Reduced Anxiety and Depression in Patients With Advanced Heart Failure After Left Ventricular Assist Device Implantation.

Science.gov (United States)

Yost, Gardner; Bhat, Geetha; Mahoney, Edward; Tatooles, Antone

Despite the high prevalence of depression and anxiety in patients with advanced heart failure, the effects of left ventricular assist device (LVAD) implantation on these critically important aspects of mental health are not well understood. We sought to assess changes in depression and anxiety following LVAD implantation. The Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI) were administered to 54 patients by a clinical psychologist at a mean of 12 days before LVAD implantation and 251 days after implantation. Patient demographics and clinical data were collected concurrently to psychologic testing. Changes in BDI-II, BAI, and clinical markers of heart failure were assessed using paired t-tests. A p Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved.

Successful Implantation of a Left Ventricular Assist Device in a Patient with Heparin-Induced Thrombocytopenia and Thrombosis

Science.gov (United States)

Garland, Cassandra; Somogyi, David

2014-01-01

Abstract: We report the case of a 27-year-old woman with signs of heparin-induced thrombocytopenia and thrombosis (HITT) and left heart failure presenting for urgent implantation of a left ventricular assist device (LVAD). HITT can occur in 4.2–6.1% of patients with LVADs. If the patient remains hemodynamically stable, implantation can be delayed for several months until the heparin/PF-4 antibodies decline allowing the use of heparin on cardiopulmonary bypass, However, in most cases related to cardiogenic shock, surgery cannot be delayed. We present the case of a patient who underwent implantation of a HeartMate II LVAD and discuss management strategy using bivalirudin during cardiopulmonary bypass. PMID:25208434

Ethical challenges with the left ventricular assist device as a destination therapy

Directory of Open Access Journals (Sweden)

Rady Mohamed Y

2008-08-01

Full Text Available Abstract The left ventricular assist device was originally designed to be surgically implanted as a bridge to transplantation for patients with chronic end-stage heart failure. On the basis of the REMATCH trial, the US Food and Drug Administration and the US Centers for Medicare & Medicaid Services approved permanent implantation of the left ventricular assist device as a destination therapy in Medicare beneficiaries who are not candidates for heart transplantation. The use of the left ventricular assist device as a destination therapy raises certain ethical challenges. Left ventricular assist devices can prolong the survival of average recipients compared with optimal medical management of chronic end-stage heart failure. However, the overall quality of life can be adversely affected in some recipients because of serious infections, neurologic complications, and device malfunction. Left ventricular assist devices alter end-of-life trajectories. The caregivers of recipients may experience significant burden (e.g., poor physical health, depression, anxiety, and posttraumatic stress disorder from destination therapy with left ventricular assist devices. There are also social and financial ramifications for recipients and their families. We advocate early utilization of a palliative care approach and outline prerequisite conditions so that consenting for the use of a left ventricular assist device as a destination therapy is a well informed process. These conditions include: (1 direct participation of a multidisciplinary care team, including palliative care specialists, (2 a concise plan of care for anticipated device-related complications, (3 careful surveillance and counseling for caregiver burden, (4 advance-care planning for anticipated end-of-life trajectories and timing of device deactivation, and (5 a plan to address the long-term financial burden on patients, families, and caregivers. Short-term mechanical circulatory devices (e

State-of-the-art implantable cardiac assist device therapy for heart failure: bridge to transplant and destination therapy.

Science.gov (United States)

Park, S J; Kushwaha, S S; McGregor, C G A

2012-01-01

Congestive heart failure is associated with poor quality of life (QoL) and low survival rates. The development of state-of-the-art cardiac devices holds promise for improved therapy in patients with heart failure. The field of implantable cardiac assist devices is changing rapidly with the emergence of continuous-flow pumps (CFPs). The important developments in this field, including pertinent clinical trials, registry reports, innovative research, and potential future directions are discussed in this paper.

Optimal Timing of Heart Transplant After HeartMate II Left Ventricular Assist Device Implantation.

Science.gov (United States)

Steffen, Robert J; Blackstone, Eugene H; Smedira, Nicholas G; Soltesz, Edward G; Hoercher, Katherine J; Thuita, Lucy; Starling, Randall C; Mountis, Maria; Moazami, Nader

2017-11-01

Optimal timing of heart transplantation in patients supported with second-generation left ventricular assist devices (LVADs) is unknown. Despite this, patients with LVADs continue to receive priority on the heart transplant waiting list. Our objective was to determine the optimal timing of transplantation for patients bridged with continuous-flow LVADs. A total of 301 HeartMate II LVADs (Thoratec Corp, Pleasanton, CA) were implanted in 285 patients from October 2004 to June 2013, and 86 patients underwent transplantation through the end of follow-up. Optimal transplantation timing was the product of surviving on LVAD support and surviving transplant. Three-year survival after both HeartMate II implantation and heart transplantation was unchanged when transplantation occurred within 9 months of implantation. Survival decreased as the duration of support exceeded this. Preoperative risk factors for death on HeartMate II support were prior valve operation, prior coronary artery bypass grafting, low albumin, low glomerular filtration rate, higher mean arterial pressure, hypertension, and earlier date of implant. Survival for patients without these risk factors was lowest when transplant was performed within 3 months but was relatively constant with increased duration of support. Longer duration of support was associated with poorer survival for patients with many of these risk factors. Device reimplantation, intracranial hemorrhage, and postimplant dialysis during HeartMate II support were associated with decreased survival. Survival of patients supported by the HeartMate II is affected by preoperative comorbidities and postoperative complications. Transplantation before complications is imperative in optimizing survival. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Implantable electronic medical devices

CERN Document Server

Fitzpatrick, Dennis

2014-01-01

Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation t

Durability of central aortic valve closure in patients with continuous flow left ventricular assist devices.

Science.gov (United States)

McKellar, Stephen H; Deo, Salil; Daly, Richard C; Durham, Lucian A; Joyce, Lyle D; Stulak, John M; Park, Soon J

2014-01-01

A competent aortic valve is essential to providing effective left ventricular assist device support. We have adopted a practice of central aortic valve closure by placing a simple coaptation stitch at left ventricular assist device implantation in patients with significant aortic insufficiency. We conducted a follow-up study to evaluate the efficacy and durability of this procedure. The study included patients who had undergone continuous flow left ventricular assist device implantation. The patients were divided into 2 groups, those who did not require any aortic procedure because the valve was competent and those who underwent central aortic valve closure for mild or greater aortic regurgitation. The clinical endpoints were mortality, progression or recurrence of aortic insufficiency, and reoperation for aortic valve pathologic features. Aortic insufficiency was measured qualitatively from mild to severe on a scale of 0 to 5. A total of 123 patients received continuous flow left ventricular assist devices from February 2007 to August 2011. Of those, 18 (15%) underwent central aortic valve closure at left ventricular assist device implantation because of significant aortic insufficiency (1.8 ± 1.4) and 105 who did not (competent aortic valve, 0.15 ± 0.43; P assist device-supported patients, with follow-up extending into 2 years. Although aortic insufficiency progressed over time in those with minimal native valve regurgitation initially, no such progression was noted in those with central aortic valve closure. Additional investigation is needed to evaluate whether prophylactic central aortic valve closure should be performed at left ventricular assist device implantation to avoid problematic aortic regurgitation developing over time, in particular in patients undergoing left ventricular assist device implantation for life-long (destination therapy) support. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights

Left Ventricular Assist Devices

Directory of Open Access Journals (Sweden)

Khuansiri Narajeenron

2017-04-01

Full Text Available Audience: The audience for this classic team-based learning (cTBL session is emergency medicine residents, faculty, and students; although this topic is applicable to internal medicine and family medicine residents. Introduction: A left ventricular assist device (LVAD is a mechanical circulatory support device that can be placed in critically-ill patients who have poor left ventricular function. After LVAD implantation, patients have improved quality of life.1 The number of LVAD patients worldwide continues to rise. Left-ventricular assist device patients may present to the emergency department (ED with severe, life-threatening conditions. It is essential that emergency physicians have a good understanding of LVADs and their complications. Objectives: Upon completion of this cTBL module, the learner will be able to: 1 Properly assess LVAD patients’ circulatory status; 2 appropriately resuscitate LVAD patients; 3 identify common LVAD complications; 4 evaluate and appropriately manage patients with LVAD malfunctions. Method: The method for this didactic session is cTBL.

Implantable Medical Devices

Science.gov (United States)

... Artery Disease Venous Thromboembolism Aortic Aneurysm More Implantable Medical Devices Updated:Sep 16,2016 For Rhythm Control ... a Heart Attack Introduction Medications Surgical Procedures Implantable Medical Devices • Life After a Heart Attack • Heart Attack ...

A novel implantable electromechanical ventricular assist device - First acute animal testing

NARCIS (Netherlands)

Kaufmann, R; Rakhorst, G; Mihaylov, D; Elstrodt, J; Nix, C; Reul, H; Rau, G

1997-01-01

A novel ventricular assist device (HIA-EMLVAD-AT1, Helmholtz Institute Aachen-electromechanical Left Ventricular Assist Device-Animal Test Version 1), driven by a uniformly and unidirectionally rotating actuator and a patented hypocycloidic pusherplate displacement gear unit, was developed and

Preoperative atrial fibrillation increases risk of thromboembolic events after left ventricular assist device implantation.

Science.gov (United States)

Stulak, John M; Deo, Salil; Schirger, John; Aaronson, Keith D; Park, Soon J; Joyce, Lyle D; Daly, Richard C; Pagani, Francis D

2013-12-01

Because no series has specifically analyzed the impact of preoperative atrial fibrillation (AF) on patients already at higher risk of thromboembolism after implantation of a left ventricular assist device (LVAD), we review our experience with these patients. Between July 2003 and September 2011, 389 patients (308 male) underwent implantation of a continuous flow LVAD at University of Michigan Hospital and Mayo Clinic. Median age at implant was 60 years (range, 18 to 79 years). Preoperative AF was present in 120 patients (31%). Outcomes were analyzed for the association of preoperative AF and postoperative thromboembolic (TE) events defined as stroke, transient ischemic attack, hemolysis, or pump thrombosis. Thromboembolic events occurring within the first 30 days were not counted. One hundred thirty-eight TEs events occurred in 97/389 patients (25%) for an event rate of 0.31 TE events/patient-years of support. Freedom from a TE event in patients with preoperative AF was 62% at 1 year and 46% at 2 years compared with 79% and 72% at 1 and 2 years, respectively, in patients without preoperative AF (p < 0.001). Median survival was 10 months (maximum 7.2 years, total 439 patient-years). Preoperative AF did not decrease late survival at 1 and 2 years after LVAD implant (preop AF: 85% and 70% versus no preop AF: 82% and 70%, respectively; p = 0.55). Patients with preoperative AF have a lower freedom from TE events after LVAD implant. While overall late survival was not significantly reduced in these patients, refinement in anticoagulation strategies after VAD implant may be required. Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Complications after cardiac implantable electronic device implantations

DEFF Research Database (Denmark)

Kirkfeldt, Rikke Esberg; Johansen, Jens Brock; Nohr, Ellen Aagaard

2013-01-01

Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient...

Implantation damage in silicon devices

International Nuclear Information System (INIS)

Nicholas, K.H.

1977-01-01

Ion implantation, is an attractive technique for producing doped layers in silicon devices but the implantation process involves disruption of the lattice and defects are formed, which can degrade device properties. Methods of minimizing such damage are discussed and direct comparisons made between implantation and diffusion techniques in terms of defects in the final devices and the electrical performance of the devices. Defects are produced in the silicon lattice during implantation but they are annealed to form secondary defects even at room temperature. The annealing can be at a low temperature ( 0 C) when migration of defects in silicon in generally small, or at high temperature when they can grow well beyond the implanted region. The defect structures can be complicated by impurity atoms knocked into the silicon from surface layers by the implantation. Defects can also be produced within layers on top of the silicon and these can be very important in device fabrication. In addition to affecting the electrical properties of the final device, defects produced during fabrication may influence the chemical properties of the materials. The use of these properties to improve devices are discussed as well as the degradation they can cause. (author)

The role of cerebral hyperperfusion in postoperative neurologic dysfunction after left ventricular assist device implantation for end-stage heart failure.

Science.gov (United States)

Lietz, Katherine; Brown, Kevin; Ali, Syed S; Colvin-Adams, Monica; Boyle, Andrew J; Anderson, David; Weinberg, Alan D; Miller, Leslie W; Park, Soon; John, Ranjit; Lazar, Ronald M

2009-04-01

Cerebral hyperperfusion is a life-threatening syndrome that can occur in patients with chronically hypoperfused cerebral vasculature whose normal cerebral circulation was re-established after carotid endarterectomy or angioplasty. We sought to determine whether the abrupt restoration of perfusion to the brain after left ventricular assist device (LVAD) implantation produced similar syndromes. We studied the role of increased systemic flow after LVAD implantation on neurologic dysfunction in 69 consecutive HeartMate XVE LVAD (Thoratec, Pleasanton, Calif) recipients from October 2001 through June 2006. Neurologic dysfunction was defined as postoperative permanent or transient central change in neurologic status, including confusion, focal neurologic deficits, visual changes, seizures, or coma for more than 24 hours within 30 days after LVAD implantation. We found that 19 (27.5%) patients had neurologic dysfunction, including encephalopathy (n = 11), coma (n = 3), and other complications (n = 5). The multivariate analysis showed that an increase in cardiac index from the preoperative baseline value (relative risk, 1.33 per 25% cardiac index increase; P = .01) and a previous coronary bypass operation (relative risk, 4.53; P = .02) were the only independent predictors of neurologic dysfunction. Reduction of left ventricular assist device flow in 16 of the 19 symptomatic patients led to improvement of symptoms in 14 (87%) patients. Our findings showed that normal flow might overwhelm cerebral autoregulation in patients with severe heart failure, suggesting that cerebral hyperperfusion is possible in recipients of mechanical circulatory support with neurologic dysfunction.

Outcomes of patients with right ventricular failure on milrinone after left ventricular assist device implantation.

Science.gov (United States)

Tsiouris, Athanasios; Paone, Gaetano; Brewer, Robert J; Nemeh, Hassan W; Borgi, Jamil; Morgan, Jeffrey A

2015-01-01

Previous studies have grouped together both patients requiring right ventricular assist devices (RVADs) with patients requiring prolonged milrinone therapy after left ventricular assist device (LVAD) implantation. We retrospectively identified 149 patients receiving LVADs and 18 (12.1%) of which developed right ventricular (RV) failure. We then separated these patients into those requiring RVADs versus prolonged milrinone therapy. This included 10 patients who were treated with prolonged milrinone and eight patients who underwent RVAD placement. Overall, the RV failure group had worse survival compared with the non-RV failure cohort (p = 0.038). However, this was only for the subgroup of patients who required RVADs, who had a 1, 6, 12, and 24 month survival of 62.5%, 37.5%, 37.5%, and 37.5%, respectively, versus 96.8%, 92.1%, 86.7%, and 84.4% for patients without RV failure (p milrinone therapy for RV failure had similar survivals compared with patients without RV failure. In the RV failure group, age, preoperative renal failure, and previous cardiac surgery were predictors of the need for prolonged postoperative milrinone. As LVADs become a more widely used therapy for patients with refractory, end-stage heart failure, it will be important to reduce the incidence of RV failure, as it yields significant morbidity and increases cost.

Implantable photonic devices for improved medical treatments

Science.gov (United States)

Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev

2014-10-01

An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient's body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.

Beneficial aspects of real time flow measurements for the management of acute right ventricular heart failure following continuous flow ventricular assist device implantation

Directory of Open Access Journals (Sweden)

Spiliopoulos Sotirios

2012-11-01

Full Text Available Abstract Background Optimal management of acute right heart failure following the implantation of a left ventricular assist device requires a reliable estimation of left ventricular preload and contractility. This is possible by real-time pump blood flow measurements. Clinical case We performed implantation of a continuous flow left ventricular assist device in a 66 years old female patient with an end-stage heart failure on the grounds of a dilated cardiomyopathy. Real-time pump blood flow was directly measured by an ultrasonic flow probe placed around the outflow graft. Diagnosis The progressive decline of real time flow and the loss of pulsatility were associated with an increase of central venous pressure, inotropic therapy and progressive renal failure suggesting the presence of an acute right heart failure. Diagnosis was validated by echocardiography and thermodilution measurements. Treatment Temporary mechanical circulatory support of the right ventricle was successfully performed. Real time flow measurement proved to be a useful tool for the diagnosis and ultimately for the management of right heart failure including the weaning from extracorporeal membrane oxygenation.

Calculation of the ALMA Risk of Right Ventricular Failure After Left Ventricular Assist Device Implantation.

Science.gov (United States)

Loforte, Antonio; Montalto, Andrea; Musumeci, Francesco; Amarelli, Cristiano; Mariani, Carlo; Polizzi, Vincenzo; Lilla Della Monica, Paola; Grigioni, Francesco; Di Bartolomeo, Roberto; Marinelli, Giuseppe

2018-05-08

Right ventricular failure after continuous-flow left ventricular assist device (LVAD) implantation is still an unsolved issue and remains a life-threatening event for patients. We undertook this study to determine predictors of the patients who are candidates for isolated LVAD therapy as opposed to biventricular support (BVAD). We reviewed demographic, echocardiographic, hemodynamic, and laboratory variables for 258 patients who underwent both isolated LVAD implantation and unplanned BVAD because of early right ventricular failure after LVAD insertion, between 2006 and 2017 (LVAD = 170 and BVAD = 88). The final study patients were randomly divided into derivation (79.8%, n = 206) and validation (20.1%, n = 52) cohorts. Fifty-seven preoperative risk factors were compared between patients who were successfully managed with an LVAD and those who required a BVAD. Nineteen variables demonstrated statistical significance on univariable analysis. Multivariable logistic regression analysis identified destination therapy (odds ratio [OR] 2.0 [1.7-3.9], p = 0.003), a pulmonary artery pulsatility index right ventricle/left ventricle end-diastolic diameter ratio >0.75 (OR 2.7 [1.5-5.5], p = 0.001), an right ventricle stroke work index 17 (OR 3.5 [1.9-6.9], p the major predictors of the need for BVAD. Using these data, we propose a simple risk calculator to determine the suitability of patients for isolated LVAD support in the era of continuous-flow mechanical circulatory support devices.

Frailty and outcomes after implantation of left ventricular assist device as destination therapy.

Science.gov (United States)

Dunlay, Shannon M; Park, Soon J; Joyce, Lyle D; Daly, Richard C; Stulak, John M; McNallan, Sheila M; Roger, Véronique L; Kushwaha, Sudhir S

2014-04-01

Frailty is recognized as a major prognostic indicator in heart failure. There has been interest in understanding whether pre-operative frailty is associated with worse outcomes after implantation of a left ventricular assist device (LVAD) as destination therapy. Patients undergoing LVAD implantation as destination therapy at the Mayo Clinic, Rochester, Minnesota, from February 2007 to June 2012, were included in this study. Frailty was assessed using the deficit index (31 impairments, disabilities and comorbidities) and defined as the proportion of deficits present. We divided patients based on tertiles of the deficit index (>0.32 = frail, 0.23 to 0.32 = intermediate frail, <0.23 = not frail). Cox proportional hazard regression models were used to examine the association between frailty and death. Patients were censored at death or last follow-up through October 2013. Among 99 patients (mean age 65 years, 18% female, 55% with ischemic heart failure), the deficit index ranged from 0.10 to 0.65 (mean 0.29). After a mean follow-up of 1.9 ± 1.6 years, 79% of the patients had been rehospitalized (range 0 to 17 hospitalizations, median 1 per person) and 45% had died. Compared with those who were not frail, patients who were intermediate frail (adjusted HR 1.70, 95% CI 0.71 to 4.31) and frail (HR 3.08, 95% CI 1.40 to 7.48) were at increased risk for death (p for trend = 0.004). The mean (SD) number of days alive out of hospital the first year after LVAD was 293 (107) for not frail, 266 (134) for intermediate frail and 250 (132) for frail patients. Frailty before destination LVAD implantation is associated with increased risk of death and may represent a significant patient selection consideration. Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Body Implanted Medical Device Communications

Science.gov (United States)

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.

Cerebrovascular accidents in patients with a ventricular assist device.

Science.gov (United States)

Tsukui, Hiroyuki; Abla, Adib; Teuteberg, Jeffrey J; McNamara, Dennis M; Mathier, Michael A; Cadaret, Linda M; Kormos, Robert L

2007-07-01

A cerebrovascular accident is a devastating adverse event in a patient with a ventricular assist device. The goal was to clarify the risk factors for cerebrovascular accident. Prospectively collected data, including medical history, ventricular assist device type, white blood cell count, thrombelastogram, and infection, were reviewed retrospectively in 124 patients. Thirty-one patients (25%) had 48 cerebrovascular accidents. The mean ventricular assist device support period was 228 and 89 days in patients with and without cerebrovascular accidents, respectively (P cerebrovascular accidents occurred within 4 months after implantation. Actuarial freedom from cerebrovascular accident at 6 months was 75%, 64%, 63%, and 33% with the HeartMate device (Thoratec Corp, Pleasanton, Calif), Thoratec biventricular ventricular assist device (Thoratec Corp), Thoratec left ventricular assist device (Thoratec), and Novacor device (WorldHeart, Oakland, Calif), respectively. Twenty cerebrovascular accidents (42%) occurred in patients with infections. The mean white blood cell count at the cerebrovascular accident was greater than the normal range in patients with infection (12,900/mm3) and without infection (9500/mm3). The mean maximum amplitude of the thrombelastogram in the presence of infection (63.6 mm) was higher than that in the absence of infection (60.7 mm) (P = .0309). The risk of cerebrovascular accident increases with a longer ventricular assist device support period. Infection may activate platelet function and predispose the patient to a cerebrovascular accident. An elevation of the white blood cell count may also exacerbate the risk of cerebrovascular accident even in patients without infection. Selection of device type, prevention of infection, and meticulous control of anticoagulation are key to preventing cerebrovascular accident.

Current Trends in Implantable Left Ventricular Assist Devices

Directory of Open Access Journals (Sweden)

Jens Garbade

2011-01-01

Full Text Available The shortage of appropriate donor organs and the expanding pool of patients waiting for heart transplantation have led to growing interest in alternative strategies, particularly in mechanical circulatory support. Improved results and the increased applicability and durability with left ventricular assist devices (LVADs have enhanced this treatment option available for end-stage heart failure patients. Moreover, outcome with newer pumps have evolved to destination therapy for such patients. Currently, results using nonpulsatile continuous flow pumps document the evolution in outcomes following destination therapy achieved subsequent to the landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure Trial (REMATCH, as well as the outcome of pulsatile designed second-generation LVADs. This review describes the currently available types of LVADs, their clinical use and outcomes, and focuses on the patient selection process.

Surgical treatment of tricuspid valve insufficiency promotes early reverse remodeling in patients with axial-flow left ventricular assist devices.

Science.gov (United States)

Maltais, Simon; Topilsky, Yan; Tchantchaleishvili, Vakhtang; McKellar, Stephen H; Durham, Lucian A; Joyce, Lyle D; Daly, Richard C; Park, Soon J

2012-06-01

The HeartMate II (Thoratec Corp, Pleasanton, Calif) continuous-flow left ventricular assist device has emerged as the standard of care for patients with advanced heart failure. The objective of this study was to assess the safety and early effectiveness of concomitant tricuspid valve procedures in patients undergoing implantation of a HeartMate II device. From February 2007 to April 2010, 83 patients underwent HeartMate II left ventricular assist device implantation. Of these, 37 patients had concomitant tricuspid valve procedures (32 repairs, 5 replacements) for severe tricuspid regurgitation. The effects of a tricuspid valve procedure on tricuspid regurgitation and right ventricular remodeling were assessed comparing echocardiographic findings at baseline and 30 days after left ventricular assist device implantation. Overall survival was also compared. Patients undergoing a concomitant tricuspid valve procedure had more tricuspid regurgitation (vena contracta, 5.6 ± 2.1 mm vs 2.9 ± 2.0 mm; P tricuspid regurgitation was worse in patients who underwent left ventricular assist device implantation alone (+18.6%), whereas it improved significantly in patients undergoing a concomitant tricuspid valve procedure (-50.2%) (P = .005). A corresponding significant reduction in right ventricular end-diastolic area (33.6% ± 6.2% vs 30.1% ± 9.7%; P = .03) and a trend toward better right ventricular function (55.5% ± 79.7% vs 35.7% ± 60.5%; P = .28) were noted in patients undergoing a concomitant tricuspid valve procedure. Survival was comparable between the 2 groups. In patients with severe tricuspid regurgitation undergoing left ventricular assist device implantation, a concomitant tricuspid valve procedure effectively reduces tricuspid regurgitation and promotes reverse remodeling of the right ventricle. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

A pilot study of implantable cardiac device interrogation by emergency department personnel.

Science.gov (United States)

Neuenschwander, James F; Hiestand, Brian C; Peacock, W Frank; Billings, John M; Sondrup, Cole; Hummel, John D; Abraham, William T

2014-03-01

Implanted devices (eg, pacemakers and defibrillators) provide valuable information and may be interrogated to obtain diagnostic information and to direct management. During admission to an emergency department (ED), significant time and cost are spent waiting for device manufacturer representatives or cardiologists to access the data. If ED personnel could safely interrogate implanted devices, more rapid disposition could occur, thus leading to potentially better outcomes at a reduced cost. This was a pilot study examining the feasibility of ED device interrogation. This was a prospective convenience sample study of patients presenting to the ED with any chief complaint and who had an implantable device capable of being interrogated by a Medtronic reader. After obtaining informed consent, study patients underwent device interrogation by ED research personnel. After reviewing the device data, the physician documented their opinions of the value of data in aiding care. Patients were followed up at intervals ranging from 30 days out to 1 year to determine adverse events relating to interrogation. Forty-four patients underwent device interrogation. Their mean age was 56 ± 14.7 years (range, 28-83), 75% (33/44) were male and 75% (33/44) were hospitalized from the ED. The interrogations took less than 10 minutes 89% of the time. In 60% of the cases, ED physicians reported the data-assisted patient care. No adverse events were reported relating to the ED interrogations. In this pilot study, we found that ED personnel can safely and quickly interrogate implantable devices to obtain potentially useful clinical data.

The medical physics of ventricular assist devices

International Nuclear Information System (INIS)

Wood, Houston G; Throckmorton, Amy L; Untaroiu, Alexandrina; Song Xinwei

2005-01-01

Millions of patients, from infants to adults, are diagnosed with congestive heart failure each year all over the world. A limited number of donor hearts available for these patients results in a tremendous demand for alternative, supplemental circulatory support in the form of artificial heart pumps or ventricular assist devices (VADs). The development procedure for such a device requires careful consideration of biophysical factors, such as biocompatibility, haemolysis, thrombosis, implantability, physiologic control feasibility and pump performance. Conventional pump design equations based on Newton's law and computational fluid dynamics (CFD) are readily used for the initial design of VADs. In particular, CFD can be employed to predict the pressure-flow performance, hydraulic efficiencies, flow profile through the pump, stress levels and biophysical factors, such as possible blood cell damage. These computational flow simulations may involve comprehensive steady and transient flow analyses. The transient simulations involve time-varying boundary conditions and virtual modelling of the impeller rotation in the blood pumps. After prototype manufacture, laser flow measurements with sophisticated optics and mock circulatory flow loop testing assist with validation of pump design and identification of irregular flow patterns for optimization. Additionally, acute and chronic animal implants illustrate the blood pump's ability to support life physiologically. These extensive design techniques, coupled with fundamental principles of physics, ensure a reliable and effective VAD for thousands of heart failure patients each year

Extracorporeal Life Support Bridge to Ventricular Assist Device: The Double Bridge Strategy.

Science.gov (United States)

Marasco, Silvana F; Lo, Casey; Murphy, Deirdre; Summerhayes, Robyn; Quayle, Margaret; Zimmet, Adam; Bailey, Michael

2016-01-01

In patients requiring left ventricular assist device (LVAD) support, it can be difficult to ascertain suitability for long-term mechanical support with LVAD and eventual transplantation. LVAD implantation in a shocked patient is associated with increased morbidity and mortality. Interest is growing in the utilization of extracorporeal life support (ECLS) as a bridge-to-bridge support for these critically unwell patients. Here, we reviewed our experience with ECLS double bridging. We hypothesized that ECLS double bridging would stabilize end-organ dysfunction and reduce ventricular assist device (VAD) implant perioperative mortality. We conducted a retrospective review of prospectively collected data for 58 consecutive patients implanted with a continuous-flow LVAD between January 2010 and December 2013 at The Alfred Hospital, Melbourne, Victoria, Australia. Twenty-three patients required ECLS support pre-LVAD while 35 patients underwent LVAD implantation without an ECLS bridge. Preoperative morbidity in the ECLS bridge group was reflected by increased postoperative intensive care duration, blood loss, blood product use, and postoperative renal failure, but without negative impact upon survival when compared with the no ECLS group. ECLS stabilization improved end-organ function pre-VAD implant with significant improvements in hepatic and renal dysfunction. This series demonstrates that the use of ECLS bridge to VAD stabilizes end-organ dysfunction and reduces VAD implant perioperative mortality from that traditionally reported in these "crash and burn" patients. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Comparison of early versus delayed timing of left ventricular assist device implantation as a bridge-to-transplantation: An analysis of the UNOS dataset.

Science.gov (United States)

Kitada, Shuichi; Schulze, P Christian; Jin, Zhezhen; Clerkin, Kevin; Homma, Shunichi; Mancini, Donna M

2016-01-15

Placement of left ventricular assist devices (LVAD) as a bridge-to-heart transplantation (HTx) has rapidly expanded due to organ donor shortage. However, the timing of LVAD implantation is variable and it remains unclear if earlier implantation improves survival. We analyzed 14,187 adult candidates from the United Network of Organ Sharing database. Patients were classified by 3 treatment strategies including patients medically treated alone (MED, n=11,009), patients on LVAD support at listing (Early-LVAD, n=1588) and patients undergoing LVAD placement while awaiting HTx (Delayed-LVAD, n=1590). Likelihood of HTx and event-free survival were assessed in patients subcategorized by clinical strategies and UNOS status at listing. The device support strategy, despite the timing of placement, was not associated with increased likelihood of HTx compared to MED group. However, both LVAD implantation strategies showed better survival compared to MED group (Early-LVAD: HR 0.811 and 0.633, 95% CI 0.668-0.984 and 0.507-0.789, for 1A and 1B; p=0.034 and p<0.001, Delayed-LVAD: HR 0.553 and 0.696, 95% CI 0.415-0.736 and 0.571-0.847, for 1A and 1B; both p<0.001, respectively). Furthermore, there was no significant difference in survival between these LVAD implantation strategies in patients listed as 1B (p=0.500), although Early-LVAD implantation showed worse survival in patients listed as 1A (HR 1.467, 95% CI 1.076-2.000; p=0.015). LVAD support strategies offer a safe bridge-to-HTx. Those candidates who receive urgent upfront LVAD implantation for HTx, and improve to 1B status, would achieve competitive survival with those who receive elective LVAD implantation. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Implantable Medical Devices; Networking Security Survey

Directory of Open Access Journals (Sweden)

Siamak Aram

2016-08-01

Full Text Available The industry of implantable medical devices (IMDs is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable devices is rather advanced, the issue of equipping the IMDs with sufficiently strong security system remains unresolved. In fact, IMDs have relatively weak security mechanisms which render them vulnerable to cyber-attacks that compromise the quality of IMDs’ functionalities. This study revolves around the security deficiencies inherent to three types of sensor-based medical devices; biosensors, insulin pump systems and implantable cardioverter defibrillators. Manufacturers of these devices should take into consideration that security and effectiveness of the functionality of implants is highly dependent on the design. In this paper, we present a comprehensive study of IMDs’ architecture and specifically investigate their vulnerabilities at networking interface.

Modulation Techniques for Biomedical Implanted Devices and Their Challenges

Directory of Open Access Journals (Sweden)

Salina A. Samad

2011-12-01

Full Text Available Implanted medical devices are very important electronic devices because of their usefulness in monitoring and diagnosis, safety and comfort for patients. Since 1950s, remarkable efforts have been undertaken for the development of bio-medical implanted and wireless telemetry bio-devices. Issues such as design of suitable modulation methods, use of power and monitoring devices, transfer energy from external to internal parts with high efficiency and high data rates and low power consumption all play an important role in the development of implantable devices. This paper provides a comprehensive survey on various modulation and demodulation techniques such as amplitude shift keying (ASK, frequency shift keying (FSK and phase shift keying (PSK of the existing wireless implanted devices. The details of specifications, including carrier frequency, CMOS size, data rate, power consumption and supply, chip area and application of the various modulation schemes of the implanted devices are investigated and summarized in the tables along with the corresponding key references. Current challenges and problems of the typical modulation applications of these technologies are illustrated with a brief suggestions and discussion for the progress of implanted device research in the future. It is observed that the prime requisites for the good quality of the implanted devices and their reliability are the energy transformation, data rate, CMOS size, power consumption and operation frequency. This review will hopefully lead to increasing efforts towards the development of low powered, high efficient, high data rate and reliable implanted devices.

Left ventricular assist device: exercise capacity evolution and rehabilitation added value.

Science.gov (United States)

Lamotte, Michel X; Chimenti, Sara; Deboeck, Gael; Gillet, Alexis; Kacelenenbogen, Raymond; Strapart, Jonathan; Vandeneynde, Frédéric; Van Nooten, Guido; Antoine, Martine

2018-06-01

With more than 15,000 implanted patients worldwide and a survival rate of 80% at 1-year and 59% at 5-years, left ventricular assist device (LVAD) implantation has become an interesting strategy in the management of heart failure patients who are resistant to other kinds of treatment. There are limited data in the literature on the change over time of exercise capacity in LVAD patients, as well as limited knowledge about the beneficial effects that rehabilitation might have on these patients. Therefore, the aim of our study was to evaluate the evolution of exercise capacity on a cohort of patients implanted with the same device (HeartWare © ) and to analyse the potential impact of rehabilitation. Sixty-two patients implanted with a LVAD between June 2011 and June 2015 were screened. Exercise capacity was evaluated by cardiopulmonary exercise testing at 6 weeks, 6 and 12 months after implantation. We have observed significant differences in the exercise capacity and evolution between the trained and non-trained patients. Some of the trained patients nearly normalised their exercise capacity at the end of the rehabilitation programme. Exercise capacity of patient implanted with a HeartWare © LVAD increased in the early period after implantation. Rehabilitation allowed implanted patients to have a significantly better evolution compared to non-rehabilitated patients.

Intraoperative Cochlear Implant Device Testing Utilizing an Automated Remote System: A Prospective Pilot Study.

Science.gov (United States)

Lohmann, Amanda R; Carlson, Matthew L; Sladen, Douglas P

2018-03-01

Intraoperative cochlear implant device testing provides valuable information regarding device integrity, electrode position, and may assist with determining initial stimulation settings. Manual intraoperative device testing during cochlear implantation requires the time and expertise of a trained audiologist. The purpose of the current study is to investigate the feasibility of using automated remote intraoperative cochlear implant reverse telemetry testing as an alternative to standard testing. Prospective pilot study evaluating intraoperative remote automated impedance and Automatic Neural Response Telemetry (AutoNRT) testing in 34 consecutive cochlear implant surgeries using the Intraoperative Remote Assistant (Cochlear Nucleus CR120). In all cases, remote intraoperative device testing was performed by trained operating room staff. A comparison was made to the "gold standard" of manual testing by an experienced cochlear implant audiologist. Electrode position and absence of tip fold-over was confirmed using plain film x-ray. Automated remote reverse telemetry testing was successfully completed in all patients. Intraoperative x-ray demonstrated normal electrode position without tip fold-over. Average impedance values were significantly higher using standard testing versus CR120 remote testing (standard mean 10.7 kΩ, SD 1.2 vs. CR120 mean 7.5 kΩ, SD 0.7, p automated testing with regard to the presence of open or short circuits along the array. There were, however, two cases in which standard testing identified an open circuit, when CR120 testing showed the circuit to be closed. Neural responses were successfully obtained in all patients using both systems. There was no difference in basal electrode responses (standard mean 195.0 μV, SD 14.10 vs. CR120 194.5 μV, SD 14.23; p = 0.7814); however, more favorable (lower μV amplitude) results were obtained with the remote automated system in the apical 10 electrodes (standard 185.4 μV, SD 11.69 vs. CR

Toward biomaterial-based implantable photonic devices

Directory of Open Access Journals (Sweden)

Humar Matjaž

2017-03-01

Full Text Available Optical technologies are essential for the rapid and efficient delivery of health care to patients. Efforts have begun to implement these technologies in miniature devices that are implantable in patients for continuous or chronic uses. In this review, we discuss guidelines for biomaterials suitable for use in vivo. Basic optical functions such as focusing, reflection, and diffraction have been realized with biopolymers. Biocompatible optical fibers can deliver sensing or therapeutic-inducing light into tissues and enable optical communications with implanted photonic devices. Wirelessly powered, light-emitting diodes (LEDs and miniature lasers made of biocompatible materials may offer new approaches in optical sensing and therapy. Advances in biotechnologies, such as optogenetics, enable more sophisticated photonic devices with a high level of integration with neurological or physiological circuits. With further innovations and translational development, implantable photonic devices offer a pathway to improve health monitoring, diagnostics, and light-activated therapies.

Evolution of general surgical problems in patients with left ventricular assist devices.

Science.gov (United States)

McKellar, Stephen H; Morris, David S; Mauermann, William J; Park, Soon J; Zietlow, Scott P

2012-11-01

Left ventricular assist devices (LVADs) are increasingly used to treat patients with end-stage heart failure. These patients may develop acute noncardiac surgical problems around the time of LVAD implantation or, as survival continues to improve, chronic surgical problems as ambulatory patients remote from the LVAD implant. Previous reports of noncardiac surgical problems in LVAD patients included patients with older, first-generation devices and do not address newer, second-generation devices. We describe the frequency and management of noncardiac surgical problems encountered during LVAD support with these newer-generation devices to assist noncardiac surgeons involved in the care of patients with LVADs. We retrospectively reviewed the medical records of consecutive patients receiving LVADs at our institution. We collected data for any consultation by noncardiac surgeons within the scope of general surgery during LVAD support and subsequent treatment. Ninety-nine patients received implantable LVADs between 2003 and 2009 (first-generation, n = 19; second-generation, n = 80). Excluding intestinal hemorrhage, general surgical opinions were rendered for 34 patients with 49 problems, mostly in the acute recovery phase after LVAD implantation. Of those, 27 patients underwent 28 operations. Respiratory failure and intra-abdominal pathologies were the most common problems addressed, and LVAD rarely precluded operation. Patients with second-generation LVADs were more likely to survive hospitalization (P = .04) and develop chronic, rather than emergent, surgical problems. Patients with LVADs frequently require consultation from noncardiac surgeons within the scope of general surgeons and often require operation. Patients with second-generation LVADs are more likely to become outpatients and develop more elective surgical problems. Noncardiac surgeons will be increasingly involved in caring for patients with LVADs and should anticipate the problems unique to this patient

Prospective Randomized Evaluation of Implantable Cardioverter-Defibrillator Programming in Patients With a Left Ventricular Assist Device.

Science.gov (United States)

Richardson, Travis D; Hale, Leslie; Arteaga, Christopher; Xu, Meng; Keebler, Mary; Schlendorf, Kelly; Danter, Matthew; Shah, Ashish; Lindenfeld, JoAnn; Ellis, Christopher R

2018-02-23

Ventricular arrhythmias are common in patients with left ventricular assist devices (LVADs) but are often hemodynamically tolerated. Optimal implantable cardioverter defibrillator (ICD) tachy-programming strategies in patients with LVAD have not been determined. We sought to determine if an ultra-conservative ICD programming strategy in patients with LVAD affects ICD shocks. Adult patients with an existing ICD undergoing continuous flow LVAD implantation were randomized to standard ICD programming by their treating physician or an ultra-conservative ICD programming strategy utilizing maximal allowable intervals to detection in the ventricular fibrillation and ventricular tachycardia zones with use of ATP. Patients with cardiac resynchronization therapy (CRT) devices were also randomized to CRT ON or OFF. Patients were followed a minimum of 6 months. The primary outcome was time to first ICD shock. Among the 83 patients studied, we found no statistically significant difference in time to first ICD shock or total ICD shocks between groups. In the ultra-conservative group 16% of patients experienced at least one shock compared with 21% in the control group ( P =0.66). There was no difference in mortality, arrhythmic hospitalization, or hospitalization for heart failure. In the 41 patients with CRT ICDs fewer shocks were observed with CRT-ON but this was not statistically significant: 10% of patients with CRT-ON (n=21) versus 38% with CRT-OFF (n=20) received shocks ( P =0.08). An ultra-conservative programming strategy did not reduce ICD shocks. Programming restrictions on ventricular tachycardia and ventricular fibrillation zone therapy should be reconsidered for the LVAD population. The role of CRT in patients with LVAD warrants further investigation. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01977703. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Quantum effects in ion implanted devices

International Nuclear Information System (INIS)

Jamieson, D.N.; Chan, V.; Hudson, F.E.; Andresen, S.E.; Yang, C.; Hopf, T.; Hearne, S.M.; Pakes, C.I.; Prawer, S.; Gauja, E.; Yang, C.; Dzurak, A.S.; Yang, C.; Clark, R.G.; Yang, C.

2005-01-01

Fabrication of nanoscale devices that exploit the rules of quantum mechanics to process information presents formidable technical challenges because it will be necessary to control quantum states at the level of individual atoms, electrons or photons. We have developed a pathway to the construction of quantum devices using ion implantation and demonstrate, using charge transport analysis, that the devices exhibit single electron effects. We construct devices that employ two P donors in Si by employing the technique of ion beam induced charge (IBIC) in which single 14 keV P ions can be implanted into ultra-pure silicon by monitoring on-substrate detector electrodes. We have used IBIC with a MeV nuclear microprobe to map and measure the charge collection efficiency in the development of the electrode structure and show that 100% charge collection efficiency can be achieved leading to the fabrication of prototype devices that display quantum effects in the transport of single charge quanta between the islands of implanted donors. (author). 9 refs., 4 figs., 1 tab

Left Ventricular Assist Devices: The Adolescence of a Disruptive Technology.

Science.gov (United States)

Pinney, Sean P

2015-10-01

Clinical outcomes for patients with advanced heart failure receiving left ventricular assist devices are driven by appropriate patient selection, refined surgical technique, and coordinated medical care. Perhaps even more important is innovative pump design. The introduction and widespread adoption of continuous-flow ventricular assist devices has led to a paradigm shift within the field of mechanical circulatory support, making the promise of lifetime device therapy closer to reality. The disruption caused by this new technology, on the one hand, produced meaningful improvements in patient survival and quality of life, but also introduced new clinical challenges, such as bleeding, pump thrombosis, and acquired valvular heart disease. Further evolution within this field will require financial investment to sustain innovation leading to a fully implantable, durable, and cost-effective pump for a larger segment of patients with advanced heart failure. Copyright © 2015 Elsevier Inc. All rights reserved.

Power Approaches for Implantable Medical Devices

Directory of Open Access Journals (Sweden)

Achraf Ben Amar

2015-11-01

Full Text Available Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health. In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources.

Development of Implantable Medical Devices: From an Engineering Perspective

Directory of Open Access Journals (Sweden)

Yeun-Ho Joung

2013-09-01

Full Text Available From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind.

Exercise therapy for an older patient with left ventricular assist device.

Science.gov (United States)

Park, Won Hah; Seo, Yong Gon; Sung, Ji Dong

2014-06-01

A left ventricular assist device (LVAD) is a mechanical circulation support implanted for patients with end-stage heart failure. It may be used either as a bridge to cardiac transplantation or as a destination therapy. The health of a 75-year-old man with a medical history of systolic heart failure worsened. Therefore, he was recommended to have implanted a LVAD (Thoratec Corp.) as a destination therapy. After the surgery, he was enrolled in patient cardiac rehabilitation for the improvement of dyspnea and exercise capacity. In results, there is an improvement on his exercise capacity and quality of life. For the first time in Korea, we reported a benefit of exercise therapy after being implanted with a LVAD.

The Achilles' heel of left ventricular assist device therapy: right ventricle.

Science.gov (United States)

Ranganath, Neel K; Smith, Deane E; Moazami, Nader

2018-06-01

Many patients suffer from either persistent right ventricular failure (RVF) at the time of left ventricular assist device (LVAD) or have ongoing symptoms consistent with RVF during chronic mechanical circulatory support. The lack of long-term right ventricular assist devices (RVADs) has limited the impact that mechanical circulatory support can provide to patients with biventricular failure. We aim to review the entire spectrum of RVF in patients receiving LVADs and reflect on why this entity remains the Achilles' heel of LVAD therapy. In the early postoperative period, LVAD implantation reduces right ventricle (RV) afterload, but RV dysfunction may be exacerbated secondary to increased venous return. With prolonged therapy, the decreased RV afterload leads to improved RV contractile function. Bayesian statistical models outperform previously published preoperative risk scores by considering inter-relationships and conditional probabilities amongst independent variables. Various echocardiographic parameters and the pulmonary artery pulsatility index have shown promise in predicting post-LVAD RVF. Recent publications have delineated the emergence of 'delayed' RVF. Several devices are currently being investigated for use as RVADs. Post-LVAD RVF depends on the RV's ability to adapt to acute hemodynamic changes imposed by the LVAD. Management options are limited due to the lack of an easily implantable, chronic-use RVAD.

The Effect of Preoperative Cognitive Behavior and Exercise Therapy for a Patient With an Implanted Left Ventricular Assist Device in Korea.

Science.gov (United States)

Seo, Yong Gon; Park, Won Hah; Jeon, Eun Seok; Sung, Ji Dong; Jang, Mi Ja

2017-10-01

Left ventricular assist devices (LVADs) are used in patients with progressive heart failure symptoms to provide circulatory support. Patients with LVADs are referred to inpatient cardiac rehabilitation to prevent postoperative complications and improve aerobic capacity and quality of life. Preoperative exercise therapy for cardiac patients is an emerging treatment modality, and several studies have reported that it improves postoperative outcomes, such as length of hospital stay and postoperative complications. This case report describes the benefits of preoperative cognitive behavioral and exercise therapy in a Korean patient undergoing LVAD implantation. V. Copyright © 2017 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Management issues during HeartWare left ventricular assist device implantation and the role of transesophageal echocardiography

Directory of Open Access Journals (Sweden)

Sanjay Orathi Patangi

2013-01-01

Full Text Available Left ventricular assist devices (LVAD are increasingly used for mechanical circulatory support of patients with severe heart failure, primarily as a bridge to heart transplantation. Transesophageal echocardiography (TEE plays a major role in the clinical decision making during insertion of the devices and in the post-operative management of these patients. The detection of structural and device-related mechanical abnormalities is critical for optimal functioning of assist device. In this review article, we describe the usefulness of TEE for optimal perioperative management of patients presenting for HeartWare LVAD insertion.

Impact of Tricuspid Valve Surgery at the Time of Left Ventricular Assist Device Insertion on Postoperative Outcomes

OpenAIRE

Dunlay, Shannon M.; Deo, Salil V.; Park, Soon J.

2015-01-01

Tricuspid regurgitation (TR) is common in patients with heart failure undergoing left ventricular assist device (LVAD) implantation. Whether the TR should be surgically managed at the time of LVAD surgery is controversial.

Quality of Life, Depression, and Anxiety in Ventricular Assist Device Therapy: Longitudinal Outcomes for Patients and Family Caregivers.

Science.gov (United States)

Bidwell, Julie T; Lyons, Karen S; Mudd, James O; Gelow, Jill M; Chien, Christopher V; Hiatt, Shirin O; Grady, Kathleen L; Lee, Christopher S

Patients who receive ventricular assist device (VAD) therapy typically rely on informal caregivers (family members or friends) to assist them in managing their device. The purpose of this study is to characterize changes in person-oriented outcomes (quality of life [QOL], depression, and anxiety) for VAD patients and their caregivers together from pre-implantation to 3 months post-implantation. This was a formal interim analysis from an ongoing prospective study of VAD patients and caregivers (n = 41 dyads). Data on person-oriented outcomes (QOL: EuroQol 5 Dimensions Visual Analog Scale; depression: Patient Health Questionnaire-8; anxiety: Brief Symptom Inventory) were collected at 3 time points (just prior to implantation and at 1 and 3 months post-implantation). Trajectories of change for patients and caregivers on each measure were estimated using latent growth modeling with parallel processes. Patients' QOL improved significantly over time, whereas caregiver QOL worsened. Depression and anxiety also improved significantly among patients but did not change among caregivers. There was substantial variability in change on all outcomes for both patients and their caregivers. This is the first quantitative study of VAD patient-caregiver dyads in modern devices that describes change in person-oriented outcomes from pre-implantation to post-implantation. This work supports the need for future studies that account for the inherent relationships between patient and caregiver outcomes and examine variability in patient and caregiver responses to VAD therapy.

Sex and intimacy among patients with implantable left-ventricular assist devices.

Science.gov (United States)

Marcuccilli, Linda; Casida, Jesus Jessie; Peters, Rosalind M; Wright, Susan

2011-01-01

Left-ventricular assist devices (LVADs) sustain and improve the quality of life of people living with an advanced stage of heart failure. Past research focused on the development and advancement of LVAD technology, complications, and survival rates. Limited research addressed the psychosocial aspects of living with an LVAD, yet research related to sexual functioning and intimacy is lacking. The purpose of this study was to explore and describe sex and intimacy among adults living with an LVAD. We used an interpretive phenomenological study to explore the experiences of adults living with a long-term implantable LVAD, including the effect of the LVAD on their intimate and sexual functioning. Semistructured interviews were conducted with 7 men and 2 women, 31 to 70 years of age, who had lived with the LVAD at home for at least 3 months. Interviews were audiorecorded and transcribed. The wholistic and selective approach by van Manen (Researching Lived Experience: Human Science for an Action Sensitive Pedagogy. Albany, NY: SUNY Press; 1990) guided the analysis and interpretation of the transcribed interviews. Data were organized and coded into words and phrases using qualitative software. Three themes emerged from the data: (a) improved sexual relations with LVAD, (b) sexual adjustment, and (c) nonsexual intimacy. The themes identified were consistent with the concept of normalcy from the theory of self-care. Participants reported that as the LVAD improved their overall health, their sexual functioning also improved. Participants also reported an increased sense of connectedness and intimacy with their partners even in the absence of sexual intercourse. Participants discussed ways in which they continued to develop intimate relationships even in the presence of limitations in structural and functional integrity. The knowledge derived from this study can be used as a guide for healthcare providers in counseling LVAD recipients on psychosocial and sexual health essential

Ion implantation in advanced planar and vertical devices

International Nuclear Information System (INIS)

Gossmann, Hans-Joachim L.

2005-01-01

The extent ('gate overlap') and slope ('abruptness') of the lateral junction are quickly replacing vertical junction depth as the most important physical junction metrics in advanced device architectures. This is in particular true for ultra-thin body devices, where the vertical junction is limited by a geometric constraint. The optimum gate overlap is quite small, or may even be negative, making a process without the need of high-tilt implantation feasible, even for dopant activation with negligible diffusion by flash annealing or laser thermal processing. Dopant activation by solid phase epitaxial regrowth might require high-tilt implants for a positive overlap. The use of such implants, however, is expected to lead to severe gate-poly and gate-oxide degradation. Scaling the 150 nm technology has drastically shrunk the overlap, accomplished by an equally aggressive reduction in thermal budget. For a 65 nm node device, a significant fraction of the overlap originates in the as-implanted dopant profile and the importance of diffusion is diminished. As a consequence small changes in the as-implanted profile are beginning to have a disproportionate impact on device characteristics. Small angular deviations of the incident beam from normal incidence, as seen by the wafer, lead to large changes in on-current. This can be alleviated significantly by a quad implant provided the tilt-angle is sufficiently large, in the order >5 deg.

Association of HeartMate II left ventricular assist device flow estimate with thermodilution cardiac output.

Science.gov (United States)

Hasin, Tal; Huebner, Marianne; Li, Zhuo; Brown, Daniel; Stulak, John M; Boilson, Barry A; Joyce, Lyle; Pereira, Naveen L; Kushwaha, Sudhir S; Park, Soon J

2014-01-01

Cardiac output (CO) assessment is important in treating patients with heart failure. Durable left ventricular assist devices (LVADs) provide essentially all CO. In currently used LVADs, estimated device flow is generated by a computerized algorithm. However, LVAD flow estimate may be inaccurate in tracking true CO. We correlated LVAD (HeartMate II) flow with thermodilution CO during postoperative care (day 2-10 after implant) in 81 patients (5,616 paired measurements). Left ventricular assist device flow and CO correlated with a low correlation coefficient (r = 0.42). Left ventricular assist device readings were lower than CO measurements by approximately 0.36 L/min, trending for larger difference with higher values. Left ventricular assist device flow measurements showed less temporal variability compared with CO. Grouping for simultaneous measured blood pressure (BP device flow generally trends with measured CO, but large variability exists, hence flow measures should not be assumed to equal with CO. Clinicians should take into account variables such as high CO, BP, and opening of the aortic valve when interpreting LVAD flow readout. Direct flow sensors incorporated in the LVAD system may allow for better estimation.

Implant Strategy-Specific Changes in Symptoms in Response to Left Ventricular Assist Devices.

Science.gov (United States)

Lee, Christopher S; Gelow, Jill M; Chien, Christopher V; Hiatt, Shirin O; Bidwell, Julie T; Denfeld, Quin E; Grady, Kathleen L; Mudd, James O

Although we know that the quality of life generally improves after left ventricular assist device (LVAD) implantation, we know little about how symptoms change in response to LVAD. The purpose of this study was to compare the changes in symptoms between bridge and destination therapy patients as part of a prospective cohort study. Physical (dyspnea and wake disturbances) and affective symptoms (depression and anxiety) were measured before LVAD and at 1, 3, and 6 months after LVAD. Multiphase growth modeling was used to capture the 2 major phases of change: initial improvements between preimplant and 1 month after LVAD and subsequent improvements between 1 and 6 months after LVAD. The sample included 64 bridge and 22 destination therapy patients as the preimplant strategy. Destination patients had worse preimplant dyspnea and wake disturbances, and they experienced greater initial improvements in these symptoms compared with bridge patients (all P .05). Destination patients had worse preimplant depression (P = .042) but experienced similar initial and subsequent improvements in depression in response to LVAD compared with bridge patients (both P > .05). Destination patients had similar preimplant anxiety (P = .279) but experienced less initial and greater subsequent improvements in anxiety after LVAD compared with bridge patients (both P < .05). There are many differences in the magnitude and timing of change in symptom responses to LVAD between bridge and destination therapy patients. Detailed information on changes in specific symptoms may better inform shared decision-making regarding LVAD.

Left ventricular assist device implantation via left thoracotomy: alternative to repeat sternotomy.

Science.gov (United States)

Pierson, Richard N; Howser, Renee; Donaldson, Terri; Merrill, Walter H; Dignan, Rebecca J; Drinkwater, Davis C; Christian, Karla G; Butler, Javed; Chomsky, Don; Wilson, John R; Clark, Rick; Davis, Stacy F

2002-03-01

Repeat sternotomy for left ventricular assist device insertion may result in injury to the right heart or patent coronary grafts, complicating intraoperative and postoperative management. In 4 critically ill patients, left thoracotomy was used as an alternative to repeat sternotomy. Anastomosis of the outflow conduit to the descending thoracic aorta provided satisfactory hemodynamic support.

Radiographic appearances of uncommon paediatric implants and devices

Energy Technology Data Exchange (ETDEWEB)

Urquia, Arlen; Watson, Tom A.; Arthurs, Owen J. [Great Ormond Street Hospital NHS Foundation Trust, Department of Radiology, London (United Kingdom)

2015-06-15

As childhood survival of chronic illness improves, long-term implanted devices will be encountered more frequently in routine radiology. In our paediatric tertiary referral hospital, we have come across several types of implanted devices that were not confidently recognised or identified by front-line staff and were often only identified by discussion with the patient, family or clinical team. This pictorial review highlights the appearance of nonvascular devices on paediatric radiographs in order to help clinicians identify the most frequent complications and to improve awareness of these important devices. (orig.)

Electromagnetic Interference in Implantable Rhythm Devices - The Indian Scenario

Directory of Open Access Journals (Sweden)

Johnson Francis

2002-07-01

Full Text Available Implantable rhythm device (IRD is the generic name for the group of implantable devices used for diagnosis and treatment of cardiac arrhythmias. Devices in this category include cardiac pacemakers, implantable cardioverter defibrillators and implantable loop recorders. Since these devices have complex microelectronic circuitry and use electromagnetic waves for communication, they are susceptible to interference from extraneous sources of electromagnetic radiation and magnetic energy. Electromagnetic interference (EMI is generally not a major problem outside of the hospital environment. The most important interactions occur when a patient is subjected to medical procedures such as magnetic resonance imaging (MRI, electrocautery and radiation therapy. Two articles in this issue of the journal discusses various aspects of EMI on IRD1,2 . Together these articles provide a good review of the various sources of EMI and their interaction with IRD for the treating physician.

Infective endocarditis and risk of death after cardiac implantable electronic device implantation

DEFF Research Database (Denmark)

Özcan, Cengiz; Raunsø, Jakob; Lamberts, Morten

2017-01-01

AIMS: To determine the incidence, risk factors, and mortality of infective endocarditis (IE) following implantation of a first-time, permanent, cardiac implantable electronic device (CIED). METHODS AND RESULTS: From Danish nationwide administrative registers (beginning in 1996), we identified all...

Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry.

Science.gov (United States)

Gadler, Fredrik; Valzania, Cinzia; Linde, Cecilia

2015-01-01

The National Swedish Pacemaker and Implantable Cardioverter-Defibrillator (ICD) Registry collects prospective data on all pacemaker and ICD implants in Sweden. We aimed to report the 2012 findings of the Registry concerning electrical devices implantation rates and changes over time, 1 year complications, long-term device longevity and patient survival. Forty-four Swedish implanting centres continuously contribute implantation of pacemakers and ICDs to the Registry by direct data entry on a specific website. Clinical and technical information on 2012 first implants and postoperative complications were analysed and compared with previous years. Patient survival data were obtained from the Swedish population register database. In 2012, the mean pacemaker and ICD first implantation rates were 697 and 136 per million inhabitants, respectively. The number of cardiac resynchronization therapy (CRT) first implantations/million capita was 41 (CRT pacemakers) and 55 (CRT defibrillators), with only a slight increase in CRT-ICD rate compared with 2011. Most device implantations were performed in men. Complication rates for pacemaker and ICD procedures were 5.3 and 10.1% at 1 year, respectively. Device and lead longevity differed among manufacturers. Pacemaker patients were older at the time of first implant and had generally worse survival rate than ICD patients (63 vs. 82% after 5 years). Pacemaker and ICD implantation rates seem to have reached a level phase in Sweden. Implantable cardioverter-defibrillator and CRT implantation rates are very low and do not reflect guideline indications. Gender differences in CRT and ICD implantations are pronounced. Device and patient survival rates are variable, and should be considered when deciding device type. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.

The effects of cosmic radiation on implantable medical devices

International Nuclear Information System (INIS)

Bradley, P.

1996-01-01

Metal oxide semiconductor (MOS) integrated circuits, with the benefits of low power consumption, represent the state of the art technology for implantable medical devices. Three significant sources of radiation are classified as having the ability to damage or alter the behavior of implantable electronics; Secondary neutron cosmic radiation, alpha particle radiation from the device packaging and therapeutic doses(up to 70 Gγ) of high energy radiation used in radiation oncology. The effects of alpha particle radiation from the packaging may be eliminated by the use of polyimide or silicone rubber die coatings. The relatively low incidence of therapeutic radiation incident on an implantable device and the use of die coating leaves cosmic radiation induced secondary neutron single event upset (SEU) as the main pervasive ionising radiation threat to the reliability of implantable devices. A theoretical model which predicts the susceptibility of a RAM cell to secondary neutron cosmic radiation induced SEU is presented. The model correlates well within the statistical uncertainty associated with both the theoretical and field estimate. The predicted Soft Error Rate (SER) is 4.8 x l0 -12 upsets/(bit hr) compared to an observed upset rate of 8.5 x 10 -12 upsets/(bit hr) from 20 upsets collected over a total of 284672 device days. The predicted upset rate may increase by up to 20% when consideration is given to patients flying in aircraft The upset rate is also consistent with the expected geographical variations of the secondary cosmic ray neutron flux, although insufficient upsets precluded a statistically significant test. This is the first clinical data set obtained indicating the effects of cosmic radiation on implantable devices. Importantly, it may be used to predict the susceptibility of future to the implantable device designs to the effects of cosmic radiation

An Implantable Intravascular Pressure Sensor for a Ventricular Assist Device

Directory of Open Access Journals (Sweden)

Luigi Brancato

2016-08-01

Full Text Available The aim of this study is to investigate the intravascular application of a micro-electro-mechanical system (MEMS pressure sensor to directly measure the hemodynamic characteristics of a ventricular assist device (VAD. A bio- and hemo-compatible packaging strategy is implemented, based on a ceramic thick film process. A commercial sub-millimeter piezoresistive sensor is attached to an alumina substrate, and a double coating of polydimethylsiloxane (PDMS and parylene-C is applied. The final size of the packaged device is 2.6 mm by 3.6 mm by 1.8 mm. A prototype electronic circuit for conditioning and read-out of the pressure signal is developed, satisfying the VAD-specific requirements of low power consumption (less than 14.5 mW in continuous mode and small form factor. The packaged sensor has been submitted to extensive in vitro tests. The device displayed a temperature-independent sensitivity (12 μ V/V/mmHg and good in vitro stability when exposed to the continuous flow of saline solution (less than 0.05 mmHg/day drift after 50 h. During in vivo validation, the transducer has been successfully used to record the arterial pressure waveform of a female sheep. A small, intravascular sensor to continuously register the blood pressure at the inflow and the outflow of a VAD is developed and successfully validated in vivo.

Wireless microsensor network solutions for neurological implantable devices

Science.gov (United States)

Abraham, Jose K.; Whitchurch, Ashwin; Varadan, Vijay K.

2005-05-01

The design and development of wireless mocrosensor network systems for the treatment of many degenerative as well as traumatic neurological disorders is presented in this paper. Due to the advances in micro and nano sensors and wireless systems, the biomedical sensors have the potential to revolutionize many areas in healthcare systems. The integration of nanodevices with neurons that are in communication with smart microsensor systems has great potential in the treatment of many neurodegenerative brain disorders. It is well established that patients suffering from either Parkinson"s disease (PD) or Epilepsy have benefited from the advantages of implantable devices in the neural pathways of the brain to alter the undesired signals thus restoring proper function. In addition, implantable devices have successfully blocked pain signals and controlled various pelvic muscles in patients with urinary and fecal incontinence. Even though the existing technology has made a tremendous impact on controlling the deleterious effects of disease, it is still in its infancy. This paper presents solutions of many problems of today's implantable and neural-electronic interface devices by combining nanowires and microelectronics with BioMEMS and applying them at cellular level for the development of a total wireless feedback control system. The only device that will actually be implanted in this research is the electrodes. All necessary controllers will be housed in accessories that are outside the body that communicate with the implanted electrodes through tiny inductively-coupled antennas. A Parkinson disease patient can just wear a hat-system close to the implantable neural probe so that the patient is free to move around, while the sensors continually monitor, record, transmit all vital information to health care specialist. In the event of a problem, the system provides an early warning to the patient while they are still mobile thus providing them the opportunity to react and

Ventricular Assist Device implant (AB 5000 prototype cannula: In vitro assessment of MRI issues at 3-Tesla

Directory of Open Access Journals (Sweden)

Valencerina Samuel

2008-05-01

Full Text Available Abstract Purpose To evaluate MRI issues at 3-Tesla for a ventricular assist device (VAD. Methods The AB5000 Ventricle with a prototype Nitinol wire-reinforced In-Flow Cannula and Out-Flow Cannula attached (Abiomed, Inc., Danvers, MA was evaluated for magnetic field interactions, heating, and artifacts at 3-Tesla. MRI-related heating was assessed with the device in a gelled-saline-filled, head/torso phantom using a transmit/received RF body coil while performing MRI at a whole body averaged SAR of 3-W/kg for 15-min. Artifacts were assessed for the main metallic component of this VAD (atrial cannula using T1-weighted, spin echo and gradient echo pulse sequences. Results The AB5000 Ventricle with the prototype In-Flow Cannula and Out-Flow Cannula attached showed relatively minor magnetic field interactions that will not cause movement in situ. Heating was not excessive (highest temperature change, +0.8°C. Artifacts may create issues for diagnostic imaging if the area of interest is in the same area or close to the implanted metallic component of this VAD (i.e., the venous cannula. Conclusion The results of this investigation demonstrated that it would be acceptable for a patient with this VAD (AB5000 Ventricle with a prototype Nitinol wire-reinforced In-Flow Cannula and Out-Flow Cannula attached to undergo MRI at 3-Tesla or less. Notably, it is likely that the operation console for this device requires positioning a suitable distance (beyond the 100 Gauss line or in the MR control room from the 3-Tesla MR system to ensure proper function of the VAD.

[Design and application of implantable medical device information management system].

Science.gov (United States)

Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

2013-03-01

Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk.

Left ventricular assist device management in patients chronically supported for advanced heart failure.

Science.gov (United States)

Cowger, Jennifer; Romano, Matthew A; Stulak, John; Pagani, Francis D; Aaronson, Keith D

2011-03-01

This review summarizes management strategies to reduce morbidity and mortality in heart failure patients supported chronically with implantable left ventricular assist devices (LVADs). As the population of patients supported with long-term LVADs has grown, patient selection, operative technique, and patient management strategies have been refined, leading to improved outcomes. This review summarizes recent findings on LVAD candidate selection, and discusses outpatient strategies to optimize device performance and heart failure management. It also reviews important device complications that warrant close outpatient monitoring. Managing patients on chronic LVAD support requires regular patient follow-up, multidisciplinary care teams, and frequent laboratory and echocardiographic surveillance to ensure optimal outcomes.

Quantum effects in ion implanted devices

International Nuclear Information System (INIS)

Jamieson, D.N.; Chan, V.; Hudson, F.E.; Andresen, S.E.; Yang, C.; Hopf, T.; Hearne, S.M.; Pakes, C.I.; Prawer, S.; Gauja, E.; Dzurak, A.S.; Clark, R.G.

2006-01-01

Fabrication of nanoscale devices that exploit the rules of quantum mechanics to process information presents formidable technical challenges because of the need to control quantum states at the level of individual atoms, electrons or photons. We have used ion implantation to fabricate devices on the scale of 10 nm that have allowed the development and test of nanocircuitry for the control of charge transport at the level of single electrons. This fabrication method is compatible with the construction of devices that employ counted P dopants in Si by employing the technique of ion beam induced charge (IBIC) in which single 14 keV P ions can be implanted into ultra-pure silicon substrates by monitoring on-substrate detector electrodes. We have used IBIC with a MeV nuclear microprobe to map and measure the charge collection efficiency in the development of the electrode structure and show that 100% charge collection efficiency can be achieved. Prototype devices fabricated by this method have been used to investigate quantum effects in the control and transport of single electrons with potential applications to solid state quantum information processing devices

Hemodynamic Effects of Ventricular Assist Device Implantation on Norwood, Glenn, and Fontan Circulation: A Simulation Study.

Science.gov (United States)

Di Molfetta, Arianna; Amodeo, Antonio; Gagliardi, Maria G; Trivella, Maria G; Fresiello, Libera; Filippelli, Sergio; Toscano, Alessandra; Ferrari, Gianfranco

2016-01-01

The growing population of failing single-ventricle (SV) patients might benefit from ventricular assist device (VAD) support as a bridge to heart transplantation. However, the documented experience is limited to isolated case reports. Considering the complex and different physiopathology of Norwood, Glenn, and Fontan patients and the lack of established experience, the aim of this work is to realize and test a lumped parameter model of the cardiovascular system able to simulate SV hemodynamics and VAD implantation effects to support clinical decision. Hemodynamic and echocardiographic data of 30 SV patients (10 Norwood, 10 Glenn, and 10 Fontan) were retrospectively collected and used to simulate patients' baseline. Then, the effects of VAD implantation were simulated. Simulation results suggest that the implantation of VAD: (i) increases the cardiac output and the mean arterial systemic pressure in all the three palliation conditions (Norwood 77.2 and 19.7%, Glenn 38.6 and 32.2%, and Fontan 17.2 and 14.2%); (ii) decreases the SV external work (Norwood 55%, Glenn 35.6%, and Fontan 41%); (iii) decreases the pressure pulsatility index (Norwood 65.2%, Glenn 81.3%, and Fontan 64.8%); (iv) increases the pulmonary arterial pressure in particular in the Norwood circulation (Norwood 39.7%, Glenn 12.1% and Fontan 3%); and (v) decreases the atrial pressure (Norwood 2%, Glenn 10.6%, and Fontan 8.6%). Finally, the VAD work is lower in the Norwood circulation (30.4 mL·mm Hg) in comparison with Fontan (40.3 mL·mm Hg) and to Glenn (64.5 mL·mm Hg) circulations. The use of VAD in SV physiology could be helpful to bridge patients to heart transplantations by increasing the CO and unloading the SV with a decrement of the atrial pressure and the SV external work. The regulation of the pulmonary flow is challenging because the Pap is increased by the presence of VAD. The hemodynamic changes are different in the different SV palliation step. The use of numerical models

In-vivo orthopedic implant diagnostic device for sensing load, wear, and infection

Science.gov (United States)

Evans, III, Boyd McCutchen; Thundat, Thomas G.; Komistek, Richard D.; Dennis, Douglas A.; Mahfouz, Mohamed

2006-08-29

A device for providing in vivo diagnostics of loads, wear, and infection in orthopedic implants having at least one load sensor associated with the implant, at least one temperature sensor associated with the implant, at least one vibration sensor associated with the implant, and at least one signal processing device operatively coupled with the sensors. The signal processing device is operable to receive the output signal from the sensors and transmit a signal corresponding with the output signal.

Low permanent pacemaker rates following Lotus device implantation for transcatheter aortic valve replacement due to modified implantation protocol.

Science.gov (United States)

Krackhardt, Florian; Kherad, Behrouz; Krisper, Maximilian; Pieske, Burkert; Laule, Michael; Tschöpe, Carsten

2017-01-01

Conduction disturbances requiring permanent pacemaker implantation following transcatheter aortic valve replacement (TAVR) are a common problem. Pacemaker implantation rates after TAVR appear to be higher compared to conventional aortic valve replacement. The aim of this study was to analyze whether a high annulus implantation conveys the benefit of a decreased rate of permanent pacemaker implantation while being safe and successful according to Valve Academic Research Consortium 2 (VARC2)-criteria. A total of 23 patients with symptomatic severe aortic valve stenosis, an aortic annulus of 19-27 mm and at high risk for surgery were treated with the Lotus valve. In all patients the valve was implanted in a high annulus position via femoral access. The primary device performance endpoint was VARC2-defined device success after 30 days and the primary safety endpoint was the need for permanent pacemaker implantation. The mean age was 73.23 ± 7.65 years, 46% were female, 38% were New York Heart Association class III/IV at baseline. Thirty-day follow-up data were available for all patients. The VARC2-defined device success rate after 30 days was 22/23 (96%). 2/21 (10%) patients required a newly implanted pacemaker due to 3rd degree atrioventricular block. 25% of the patients developed a new left bundle branch block after valvuloplasty or device implantation. 21 of the 23 patients (96%) had no other signs of conduction disturbances after 30 days. The approach of the modified implantation technique of Lotus TAVR device was safe and effective. The incidence of need for a permanent pacemaker following TAVR could be significantly reduced due to adopted implantation protocol.

Research on ion implantation in MEMS device fabrication by theory, simulation and experiments

Science.gov (United States)

Bai, Minyu; Zhao, Yulong; Jiao, Binbin; Zhu, Lingjian; Zhang, Guodong; Wang, Lei

2018-06-01

Ion implantation is widely utilized in microelectromechanical systems (MEMS), applied for embedded lead, resistors, conductivity modifications and so forth. In order to achieve an expected device, the principle of ion implantation must be carefully examined. The elementary theory of ion implantation including implantation mechanism, projectile range and implantation-caused damage in the target were studied, which can be regarded as the guidance of ion implantation in MEMS device design and fabrication. Critical factors including implantations dose, energy and annealing conditions are examined by simulations and experiments. The implantation dose mainly determines the dopant concentration in the target substrate. The implantation energy is the key factor of the depth of the dopant elements. The annealing time mainly affects the repair degree of lattice damage and thus the activated elements’ ratio. These factors all together contribute to ions’ behavior in the substrates and characters of the devices. The results can be referred to in the MEMS design, especially piezoresistive devices.

Implantable Medical Devices; Networking Security Survey

OpenAIRE

Siamak Aram; Rouzbeh A. Shirvani; Eros G. Pasero; Mohamd F. Chouikha

2016-01-01

The industry of implantable medical devices (IMDs) is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable dev...

Assistive Devices

Science.gov (United States)

If you have a disability or injury, you may use a number of assistive devices. These are tools, products or types of equipment that help you perform tasks and activities. They may help you move around, see, communicate, eat, or get ...

Ion implantation in compound semiconductors for high-performance electronic devices

International Nuclear Information System (INIS)

Zolper, J.C.; Baca, A.G.; Sherwin, M.E.; Klem, J.F.

1996-01-01

Advanced electronic devices based on compound semiconductors often make use of selective area ion implantation doping or isolation. The implantation processing becomes more complex as the device dimensions are reduced and more complex material systems are employed. The authors review several applications of ion implantation to high performance junction field effect transistors (JFETs) and heterostructure field effect transistors (HFETs) that are based on compound semiconductors, including: GaAs, AlGaAs, InGaP, and AlGaSb

Left ventricular assist device exchange: the Toronto General Hospital experience.

Science.gov (United States)

Tsubota, Hideki; Ribeiro, Roberto V P; Billia, Filio; Cusimano, Robert J; Yau, Terrence M; Badiwala, Mitesh V; Stansfield, William E; Rao, Vivek

2017-08-01

As support times for left ventricular assist devices (LVADs) become longer, several complications requiring device exchange may occur. To our knowledge, this is the first Canadian report regarding implantable LVAD exchange. We retrospectively reviewed the cases of consecutive, unique patients implanted with an LVAD between June 2006 and October 2015 at Toronto General Hospital. In total, 122 patients were impanted with an LVAD during the study period. Eight patients required LVAD exchange, and 1 patient had 2 replacements (9 of 122, 7.3%). There were 7 HeartMate II (HMII), 1 HVAD and 1 DuraHeart pumps exchanged. Two of these exchanges occurred early at the time of initial implant, whereas 7 occurred late (range 8-623 d). Six exchanges were made owing to pump thrombosis. Of the 3 exchanges made for other causes, 1 HMII exchange was owing to a driveline fracture, 1 DuraHeart patient had early inflow obstruction requiring exchange to HMII at the initial implant, and the third had a suspected inflow obstruction with no evidence of thrombosis at the time of the procedure. The mean support time before exchange was 225 days, and time from exchange to transplant, death or ongoing support was 245 days. Three patients were successfully bridged to transplant, and at the time of data collection 2 were supported awaiting transplant. Three patients died after a mean duration of 394.3 days (range 78-673 d) of support postreplacement. Four cases were successfully performed using a subcostal approach. Pump thrombosis is the most common cause for LVAD exchange, which can be performed with acceptable morbidity and mortality. The subcostal approach may be the preferred procedure for an HMII exchange when indicated.

New horizon for infection prevention technology and implantable device

Directory of Open Access Journals (Sweden)

Yusuke Kondo, MD, PhD

2016-08-01

Full Text Available There has been a significant increase in the number of patients receiving cardiovascular implantable electronic devices (CIED over the last two decades. CIED infection represents a serious complication after CIED implantation and is associated with significant morbidity and mortality. Recently, newly advanced technologies have offered attractive and suitable therapeutic alternatives. Notably, the leadless pacemaker and anti-bacterial envelope decrease the potential risk of CIED infection and the resulting mortality, when it does occur. A completely subcutaneous implantable cardioverter defibrillator is also an alternative to the transvenous implantable cardioverter defibrillator (ICD, as it does not require implantation of any transvenous or epicardial leads. Among the patients who require ICD removal and subsequent antibiotics secondary to infection, the wearable cardioverter defibrillator represents an alternative approach to inpatient monitoring for the prevention of sudden cardiac death. In this review paper, we aimed to introduce the advanced technologies and devices for prevention of CIED infection.

Pinch-off syndrome: transection of implantable central venous access device

OpenAIRE

Sugimoto, Takuya; Nagata, Hiroshi; Hayashi, Ken; Kano, Nobuyasu

2012-01-01

As the population of people with cancer increases so does the number of patients who take chemotherapy. Majority of them are administered parentally continuously. Implantable central venous catheter device is a good choice for those patients; however, severe complication would occur concerning the devices. Pinch-off syndrome is one of the most severe complications. The authors report a severe case of pinch-off syndrome. The patient with the implantable central venous device could not take che...

Critical appraisal of cardiac implantable electronic devices: complications and management

Directory of Open Access Journals (Sweden)

Padeletti L

2011-09-01

Full Text Available Luigi Padeletti1, Giosuè Mascioli2, Alessandro Paoletti Perini1, Gino Grifoni1, Laura Perrotta1, Procolo Marchese3, Luca Bontempi3, Antonio Curnis31Istituto di Clinica Medica e Cardiologia, Università degli Studi di Firenze, Italia; 2Elettrofisiologia, Istituto Humanitas Gavazzeni, Bergamo, Italia; 3Elettrofisiologia, Spedali Civili, Brescia, ItaliaAbstract: Population aging and broader indications for the implant of cardiac implantable electronic devices (CIEDs are the main reasons for the continuous increase in the use of pacemakers (PMs, implantable cardioverter-defibrillators (ICDs and devices for cardiac resynchronization therapy (CRT-P, CRT-D. The growing burden of comorbidities in CIED patients, the greater complexity of the devices, and the increased duration of procedures have led to an augmented risk of infections, which is out of proportion to the increase in implantation rate. CIED infections are an ominous condition, which often implies the necessity of hospitalization and carries an augmented risk of in-hospital death. Their clinical presentation may be either at pocket or at endocardial level, but they can also manifest themselves with lone bacteremia. The management of these infections requires the complete removal of the device and subsequent, specific, antibiotic therapy. CIED failures are monitored by competent public authorities, that require physicians to alert them to any failures, and that suggest the opportune strategies for their management. Although the replacement of all potentially affected devices is often suggested, common practice indicates the replacement of only a minority of devices, as close follow-up of the patients involved may be a safer strategy. Implantation of a PM or an ICD may cause problems in the patients' psychosocial adaptation and quality of life, and may contribute to the development of affective disorders. Clinicians are usually unaware of the psychosocial impact of implanted PMs and ICDs. The

Accuracy of mechanical torque-limiting devices for dental implants.

Science.gov (United States)

L'Homme-Langlois, Emilie; Yilmaz, Burak; Chien, Hua-Hong; McGlumphy, Edwin

2015-10-01

A common complication in implant dentistry is unintentional implant screw loosening. The critical factor in the prevention of screw loosening is the delivery of the appropriate target torque value. Mechanical torque-limiting devices (MTLDs) are the most frequently recommended devices by the implant manufacturers to deliver the target torque value to the screw. Two types of MTLDs are available: friction-style and spring-style. Limited information is available regarding the influence of device type on the accuracy of MTLDs. The purpose of this study was to determine and compare the accuracy of spring-style and friction-style MTLDs. Five MTLDs from 6 different dental implant manufacturers (Astra Tech/Dentsply, Zimmer Dental, Biohorizons, Biomet 3i, Straumann [ITI], and Nobel Biocare) (n=5 per manufacturer) were selected to determine their accuracy in delivering target torque values preset by their manufacturers. All torque-limiting devices were new and there were 3 manufacturers for the friction-style and 3 manufacturers for the spring-style. The procedure of target torque measurement was performed 10 times for each device and a digital torque gauge (Chatillon Model DFS2-R-ND; Ametek) was used to record the measurements. Statistical analysis used nonparametric tests to determine the accuracy of the MTLDs in delivering target torque values and Bonferroni post hoc tests were used to assess pairwise comparisons. Median absolute difference between delivered torque values and target torque values of friction-style and spring-style MTLDs were not significantly different (P>.05). Accuracy of Astra Tech and Zimmer Dental friction-style torque-limiting devices were significantly different than Biohorizons torque-limiting devices (Ptorque value. Astra Tech and Zimmer Dental friction-style torque-limiting devices were significantly more accurate than Biohorizons (C) torque-limiting devices (Ptorque-limiting devices fell within ±10% of the target torque value preset by the

Design of wheel-type walking-assist device

International Nuclear Information System (INIS)

Jung, Seung Ho; Kim, Seung Ho; Kim, Chang Hoi; Seo, Yong Chil; Jung, Kyung Min; Lee, Sung Uk

2006-03-01

In this research, a outdoor wheel-type walking-assist device is developed to help an elder having a poor muscular strength at legs for walking, sitting and standing up easily at outdoors, and also for going and downing stairs. In conceptually designing, the environments of an elder's activity, the size of an elder's body and a necessary function of helping an elder are considered. This device has 4 wheels for stability. When an elder walks in incline plane with the proposed device, a rear-wing is rotated to keep the supporting device horizontal, regardless of an angle of inclination. A height-controlling device, which can control the height of the supporting device for adjusting an elder's height, is varied vertically to help an elder to sit and stand-up easily. Moreover, a outdoor wheel-type walking-assist device is conceptually designed and is made. In order to design it, the preview research is investigated firstly. On the basis of the proposed walking-assist device, the outdoor walking-assist device is designed and made. The outdoor wheel-type walking-assist device can go and down stairs automatically. This device go up and down the stair of having maximum 20cm height and an angle of 25 degrees with maximum 4 sec/stairs speed, and move at flatland with 60cm/sec speed

Postoperative B-Type Natriuretic Peptide as Predictor for Postoperative Outcomes in Patients Implanted With Left Ventricular Assist Devices.

Science.gov (United States)

Yost, Gardner; Bhat, Geetha; Pappas, Patroklos; Tatooles, Antone

2018-04-18

Brain natriuretic peptide (BNP) is a cardiac neurohormone known to correlate with left ventricular (LV) dilation, decreased contractility, and increased stiffness. Consequently, BNP has been used as a prognostic tool to assess the degree of LV unloading for patients supported by continuous-flow LV assist devices (LVADs). We assessed the prognostic value of changes in BNP in the 2 weeks after LVAD implantation. This retrospective study analyzed laboratory findings and outcomes of 189 LVAD patients. Patients were separated into two groups based on whether serum BNP levels had improved from preoperative levels by postoperative day 14. Group 1 had improvement in BNP levels, whereas group 2 had no improvement or worsening in BNP. There were no significant differences between the groups in age, gender, race, body mass index, or comorbidities. Group 1 had preoperative BNP 1,125 ± 1,078.3 pg/dl and postoperative BNP 440.2 ± 267.7 pg/dl (ΔBNP = -693.09 ± 942.4 pg/dl), whereas group 2 had preoperative BNP 346.0 ± 309.1 pg/dl and postoperative BNP 631.57 ± 483.4 pg/dl (ΔBNP = 289.32 ± 329.7 pg/dl). Postoperative survival in group 2 was significantly worse than in group 1. Rates of right ventricular failure (RVF) were significantly higher in group 2 (group 1: 39%, group 2: 52.7%; p = 0.01). In most patients implanted with a LVAD, BNP improves significantly in the postoperative period as the LV is unloaded. Our results indicate that lack of improvement in postoperative BNP is associated with longer length of stay, increased rates of RVF, and is an independent risk factor for reduced postoperative survival.

Mechanical circulatory assist device development at the Texas Heart Institute: a personal perspective.

Science.gov (United States)

Frazier, O H

2014-01-01

In December 2013, we performed our 1000th ventricular assist device implantation at the Texas Heart Institute. In my professional career, I have been fortunate to see the development of numerous mechanical circulatory support devices for the treatment of patients with advanced heart failure. In fact, most of the cardiac pumps in wide use today were developed in the Texas Heart Institute research laboratories in cooperation with the National Heart, Lung and Blood Institute or device innovators and manufacturers and implanted clinically at our partner St. Luke's Episcopal Hospital. My early involvement in this field was guided by my mentors, Dr Michael E. DeBakey and, especially, Dr Denton A. Cooley. Also, many of the advances are directly attributable to my ongoing clinical experience. What I learned daily in my surgical practice allowed me to bring insights to the development of this technology that a laboratory researcher alone might not have had. Young academic surgeons interested in this field might be well served to be active not only in laboratory research but also in clinical practice. Copyright © 2014 Elsevier Inc. All rights reserved.

Brain-controlled body movement assistance devices and methods

Energy Technology Data Exchange (ETDEWEB)

Leuthardt, Eric C.; Love, Lonnie J.; Coker, Rob; Moran, Daniel W.

2017-01-10

Methods, devices, systems, and apparatus, including computer programs encoded on a computer storage medium, for brain-controlled body movement assistance devices. In one aspect, a device includes a brain-controlled body movement assistance device with a brain-computer interface (BCI) component adapted to be mounted to a user, a body movement assistance component operably connected to the BCI component and adapted to be worn by the user, and a feedback mechanism provided in connection with at least one of the BCI component and the body movement assistance component, the feedback mechanism being configured to output information relating to a usage session of the brain-controlled body movement assistance device.

Is exercise training safe and beneficial in patients receiving left ventricular assist device therapy?

Science.gov (United States)

Alsara, Osama; Perez-Terzic, Carmen; Squires, Ray W; Dandamudi, Sanjay; Miranda, William R; Park, Soon J; Thomas, Randal J

2014-01-01

Because a limited number of patients receive heart transplantation, alternative therapies, such as left ventricular assist device (LVAD) therapy, have emerged. Published studies have shown that LVAD implantation, by itself, improves exercise tolerance to the point where it is comparable to those with mild heart failure. The improvement in exercise capacity is maximally achieved 12 weeks after LVAD therapy and can continue even after explantation of the device. This effect varies, depending on the type of LVAD and exercise training. The available data in the literature on safety and benefits of exercise training in patients after LVAD implantation are limited, but the data that are available suggest that training trends to be safe and have an impact on exercise capacity in LVAD patients. Although no studies were identified on the role of cardiac rehabilitation programs in the management of LVAD patients, it appears that cardiac rehabilitation programs offer an ideal setting for the provision of supervised exercise training in this patient group.

Pinch-off syndrome: transection of implantable central venous access device.

Science.gov (United States)

Sugimoto, Takuya; Nagata, Hiroshi; Hayashi, Ken; Kano, Nobuyasu

2012-11-30

As the population of people with cancer increases so does the number of patients who take chemotherapy. Majority of them are administered parentally continuously. Implantable central venous catheter device is a good choice for those patients; however, severe complication would occur concerning the devices. Pinch-off syndrome is one of the most severe complications. The authors report a severe case of pinch-off syndrome. The patient with the implantable central venous device could not take chemotherapy because the device occluded. Further examination revealed the transection of the catheter. The transected fragment of the catheter in the heart was successfully removed by using a loop snare placed through the right femoral vein.

Post-operative orbital imaging: a focus on implants and prosthetic devices

International Nuclear Information System (INIS)

Adams, Ashok; Mankad, Kshitij; Poitelea, Cornelia; Verity, David H.; Davagnanam, Indran

2014-01-01

Accurate interpretation of orbital imaging in the presence of either orbital implants requires a sound knowledge of both the surgical approach used and the imaging characteristics of the implanted devices themselves. In this article, the radiological appearance of the various devices used in ophthalmology, and their relationship to other orbital structures, is reviewed. In addition, the intended anatomical location, function of these devices, and clinical indications for their use are provided. (orig.)

Update on Renal Replacement Therapy: Implantable Artificial Devices and Bioengineered Organs.

Science.gov (United States)

Attanasio, Chiara; Latancia, Marcela T; Otterbein, Leo E; Netti, Paolo A

2016-08-01

Recent advances in the fields of artificial organs and regenerative medicine are now joining forces in the areas of organ transplantation and bioengineering to solve continued challenges for patients with end-stage renal disease. The waiting lists for those needing a transplant continue to exceed demand. Dialysis, while effective, brings different challenges, including quality of life and susceptibility to infection. Unfortunately, the majority of research outputs are far from delivering satisfactory solutions. Current efforts are focused on providing a self-standing device able to recapitulate kidney function. In this review, we focus on two remarkable innovations that may offer significant clinical impact in the field of renal replacement therapy: the implantable artificial renal assist device (RAD) and the transplantable bioengineered kidney. The artificial RAD strategy utilizes micromachining techniques to fabricate a biohybrid system able to mimic renal morphology and function. The current trend in kidney bioengineering exploits the structure of the native organ to produce a kidney that is ready to be transplanted. Although these two systems stem from different technological approaches, they are both designed to be implantable, long lasting, and free standing to allow patients with kidney failure to be autonomous. However, for both of them, there are relevant issues that must be addressed before translation into clinical use and these are discussed in this review.

Processing of Silver-Implanted Aluminum Nitride for Energy Harvesting Devices

Science.gov (United States)

Alleyne, Fatima Sierre

One of the more attractive sources of green energy has roots in the popular recycling theme of other green technologies, now known by the term "energy scavenging." In its most promising conformation, energy scavenging converts cyclic mechanical vibrations in the environment or random mechanical pressure pulses, caused by sources ranging from operating machinery to human footfalls, into electrical energy via piezoelectric transducers. While commercial piezoelectrics have evolved to favor lead zirconate titanate (PZT) for its combination of superior properties, the presence of lead in these ceramic compounds raises resistance to their application in anything "green" due to potential health implications during their manufacturing, recycling, or in-service application, if leaching occurs. Therefore in this study we have pursued the application of aluminum nitride (AlN) as a non-toxic alternative to PZT, seeking processing pathways to augment the modest piezoelectric performance of AlN and exploit its compatibility with complementary-metal-oxide semiconductor (CMOS) manufacturing. Such piezoelectric transducers have been categorized as microelectromechanical systems (MEMS), which despite more than a decade of research in this field, is plagued by delamination at the electrode/piezoelectric interface. Consequently the electric field essential to generate and sustain the piezoelectric response of these devices is lost, resulting in device failure. Working on the hypothesis that buried conducting layers can both mitigate the delamination problem and generate sufficient electric field to engage the operation of resonator devices, we have undertaken a study of silver ion implantation to experimentally assess its feasibility. As with most ion implantation procedures employed in semiconductor fabrication, the implanted sample is subjected to a thermal treatment, encouraging diffusion-assisted precipitation of the implanted species at high enough concentrations. The objective

Improving hemodynamics of cardiovascular system under a novel intraventricular assist device support via modeling and simulations.

Science.gov (United States)

Zhu, Shidong; Luo, Lin; Yang, Bibo; Li, Xinghui; Wang, Xiaohao

2017-12-01

Ventricular assist devices (LVADs) are increasingly recognized for supporting blood circulation in heart failure patients who are non-transplant eligible. Because of its volume, the traditional pulsatile device is not easy to implant intracorporeally. Continuous flow LVADs (CF-LVADs) reduce arterial pulsatility and only offer continuous flow, which is different from physiological flow, and may cause long-term complications in the cardiovascular system. The aim of this study was to design a new pulsatile assist device that overcomes this disadvantage, and to test this device in the cardiovascular system. Firstly, the input and output characteristics of the new device were tested in a simple cardiovascular mock system. A detailed mathematical model was established by fitting the experimental data. Secondly, the model was tested in four pathological cases, and was simulated and coupled with a fifth-order cardiovascular system and a new device model using Matlab software. Using assistance of the new device, we demonstrated that the left ventricle pressure, aortic pressure, and aortic flow of heart failure patients improved to the levels of a healthy individual. Especially, in state IV level heart failure patients, the systolic blood pressure increased from 81.34 mmHg to 132.1 mmHg, whereas the diastolic blood pressure increased from 54.28 mmHg to 78.7 mmHg. Cardiac output increased from 3.21 L/min to 5.16 L/min. The newly-developed assist device not only provided a physiological flow that was similar to healthy individuals, but also effectively improved the ability of the pathological ventricular volume. Finally, the effects of the new device on other hemodynamic parameters are discussed.

Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review.

Science.gov (United States)

Bocan, Kara N; Sejdić, Ervin

2016-03-18

Wireless energy transfer is a broad research area that has recently become applicable to implantable medical devices. Wireless powering of and communication with implanted devices is possible through wireless transcutaneous energy transfer. However, designing wireless transcutaneous systems is complicated due to the variability of the environment. The focus of this review is on strategies to sense and adapt to environmental variations in wireless transcutaneous systems. Adaptive systems provide the ability to maintain performance in the face of both unpredictability (variation from expected parameters) and variability (changes over time). Current strategies in adaptive (or tunable) systems include sensing relevant metrics to evaluate the function of the system in its environment and adjusting control parameters according to sensed values through the use of tunable components. Some challenges of applying adaptive designs to implantable devices are challenges common to all implantable devices, including size and power reduction on the implant, efficiency of power transfer and safety related to energy absorption in tissue. Challenges specifically associated with adaptation include choosing relevant and accessible parameters to sense and adjust, minimizing the tuning time and complexity of control, utilizing feedback from the implanted device and coordinating adaptation at the transmitter and receiver.

Adaptive Transcutaneous Power Transfer to Implantable Devices: A State of the Art Review

Directory of Open Access Journals (Sweden)

Kara N. Bocan

2016-03-01

Full Text Available Wireless energy transfer is a broad research area that has recently become applicable to implantable medical devices. Wireless powering of and communication with implanted devices is possible through wireless transcutaneous energy transfer. However, designing wireless transcutaneous systems is complicated due to the variability of the environment. The focus of this review is on strategies to sense and adapt to environmental variations in wireless transcutaneous systems. Adaptive systems provide the ability to maintain performance in the face of both unpredictability (variation from expected parameters and variability (changes over time. Current strategies in adaptive (or tunable systems include sensing relevant metrics to evaluate the function of the system in its environment and adjusting control parameters according to sensed values through the use of tunable components. Some challenges of applying adaptive designs to implantable devices are challenges common to all implantable devices, including size and power reduction on the implant, efficiency of power transfer and safety related to energy absorption in tissue. Challenges specifically associated with adaptation include choosing relevant and accessible parameters to sense and adjust, minimizing the tuning time and complexity of control, utilizing feedback from the implanted device and coordinating adaptation at the transmitter and receiver.

The Role of Implantable Cardioverter Defibrillators in Patients Bridged to Transplantation with a Continuous Flow Left Ventricular Assist Device: A Propensity Score Matched Analysis

Science.gov (United States)

Clerkin, Kevin J.; Topkara, Veli K.; Mancini, Donna M.; Yuzefpolskaya, Melana; Demmer, Ryan T.; Dizon, Jose M.; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C.; Garan, A. Reshad

2016-01-01

Background Implantable cardioverter defibrillators (ICD) provide a significant mortality benefit for appropriately selected patients with advanced heart failure. ICDs are associated with a mortality benefit when used in patients with a pulsatile left ventricular assist device (LVAD). However it is unclear whether patients with a continuous flow LVAD (CF-LVAD) derive the same benefit. This study sought to determine if the presence of an ICD provided a mortality benefit during CFLVAD support as a bridge to transplantation. Methods Patients were identified in the United Network for Organ Sharing (UNOS) registry that underwent LVAD implantation as bridge to transplantation from May 2004 and April 2014, with follow-up through June 2014. The primary outcome was freedom from death while on CF-LVAD support with adjustment for complications requiring UNOS listing status upgrade. Secondary endpoints included freedom from delisting while on CF-LVAD support and incidence of transplantation. Results 2,990 patients composed the study cohort and propensity score matching identified 1,012 patients with similar propensity scores. There was no difference in survival during device support between patients with and without an ICD (Hazard Ratio [HR] 1.20, 95% Confidence Interval [CI] 0.66-2.17, p=0.55). Adjusting for device complications requiring a UNOS listing status upgrade had minimal influence (HR 1.11, 95% CI 0.60-2.05, p=0.74). There was no increased risk of delisting due to being too sick for those with an ICD (HR 1.08, 95% CI 0.63-1.86, p=0.78). Likewise, the probability of transplantation was similar (HR 1.05, 95% CI 0.87-1.27, p=0.62). Conclusions Among patients bridged to transplantation with a CF-LVAD, the presence of an ICD did not reduce mortality. PMID:28089072

The role of implantable cardioverter defibrillators in patients bridged to transplantation with a continuous-flow left ventricular assist device: A propensity score matched analysis.

Science.gov (United States)

Clerkin, Kevin J; Topkara, Veli K; Mancini, Donna M; Yuzefpolskaya, Melana; Demmer, Ryan T; Dizon, Jose M; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C; Garan, A Reshad

2017-06-01

Implantable cardioverter defibrillators (ICDs) provide a significant mortality benefit for appropriately selected patients with advanced heart failure. ICDs are associated with a mortality benefit when used in patients with a pulsatile left ventricular assist device (LVAD). It is unclear whether patients with a continuous-flow LVAD (CF-LVAD) derive the same benefit. We sought to determine if the presence of an ICD provided a mortality benefit during CF-LVAD support as a bridge to transplantation. Patients were identified in the United Network for Organ Sharing (UNOS) registry who underwent LVAD implantation as bridge to transplantation between May 2004 and April 2014, with follow-up through June 2014. Primary outcome was freedom from death while on CF-LVAD support with adjustment for complications requiring UNOS listing status upgrade. Secondary end-points included freedom from delisting while on CF-LVAD support and incidence of transplantation. The study cohort comprised 2,990 patients, and propensity score matching identified 1,012 patients with similar propensity scores. There was no difference in survival during device support between patients with and without an ICD (hazard ratio [HR] = 1.20; 95% confidence interval [CI], 0.66-2.17; p = 0.55). Adjusting for device complications requiring a UNOS listing status upgrade had minimal influence (HR = 1.11; 95% CI, 0.60-2.05; p = 0.74). There was no increased risk of delisting owing to being too sick for patients with an ICD (HR = 1.08; 95% CI, 0.63-1.86; p = 0.78). Likewise, the probability of transplantation was similar (HR = 1.05; 95% CI, 0.87-1.27; p = 0.62). Among patients bridged to transplantation with a CF-LVAD, the presence of an ICD did not reduce mortality. Copyright © 2017 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Extending the Limits of Wireless Power Transfer to Miniaturized Implantable Electronic Devices

Directory of Open Access Journals (Sweden)

Hugo Dinis

2017-12-01

Full Text Available Implantable electronic devices have been evolving at an astonishing pace, due to the development of fabrication techniques and consequent miniaturization, and a higher efficiency of sensors, actuators, processors and packaging. Implantable devices, with sensing, communication, actuation, and wireless power are of high demand, as they pave the way for new applications and therapies. Long-term and reliable powering of such devices has been a challenge since they were first introduced. This paper presents a review of representative state of the art implantable electronic devices, with wireless power capabilities, ranging from inductive coupling to ultrasounds. The different power transmission mechanisms are compared, to show that, without new methodologies, the power that can be safely transmitted to an implant is reaching its limit. Consequently, a new approach, capable of multiplying the available power inside a brain phantom for the same specific absorption rate (SAR value, is proposed. In this paper, a setup was implemented to quadruple the power available in the implant, without breaking the SAR limits. A brain phantom was used for concept verification, with both simulation and measurement data.

The efficacy of maxillary protraction protocols with the micro-implant-assisted rapid palatal expander (MARPE) and the novel N2 mini-implant-a finite element study.

Science.gov (United States)

Moon, Won; Wu, Kimberley W; MacGinnis, Matthew; Sung, Jay; Chu, Howard; Youssef, George; Machado, Andre

2015-01-01

Maxillary protraction with the novel N2 mini-implant- and micro-implant-assisted rapid palatal expander (MARPE) can potentially provide significant skeletal effects without surgery, even in older patients where conventional facemask therapy has limited skeletal effects. However, the skeletal effects of altering the location and direction of force from mini-implant-assisted maxillary protraction have not been extensively analyzed. In this study, the application of the novel N2 mini-implant as an orthopedic anchorage device is explored in its ability to treat patients with class III malocclusions. A 3D cranial mesh model with associated sutures was developed from CT images and Mimics modeling software. Utilizing ANSYS simulation software, protraction forces were applied at different locations and directions to simulate conventional facemask therapy and seven maxillary protraction protocols utilizing the novel N2 mini-implant. Stress distribution and displacement were analyzed. Video animations and superimpositions were created. By changing the vector of force and location of N2 mini-implant, the maxilla was displaced differentially. Varying degrees of forward, downward, and rotational movements were observed in each case. For brachyfacial patients, anterior micro-implant-supported protraction at -45° or intermaxillary class III elastics at -45° are recommended. For dolicofacial patients, either anterior micro-implants at -15° or an intermaxillary spring at +30° is recommended. For mesofacial patients with favorable vertical maxillary position, palatal micro-implants at -30° are recommended; anterior micro-implants at -30° are preferred for shallow bites. For patients with a severe mid-facial deficiency, intermaxillary class III elastics at -30° are most effective in promoting anterior growth of the maxilla. By varying the location of N2 mini-implants and vector of class III mechanics, clinicians can differentially alter the magnitude of forward, downward, and

Simulation study of a high power density rectenna array for biomedical implantable devices

Science.gov (United States)

Day, John; Yoon, Hargsoon; Kim, Jaehwan; Choi, Sang H.; Song, Kyo D.

2016-04-01

The integration of wireless power transmission devices using microwaves into the biomedical field is close to a practical reality. Implanted biomedical devices need a long lasting power source or continuous power supply. Recent development of high efficiency rectenna technology enables continuous power supply to these implanted devices. Due to the size limit of most of medical devices, it is imperative to minimize the rectenna as well. The research reported in this paper reviews the effects of close packing the rectenna elements which show the potential of directly empowering the implanted devices, especially within a confined area. The rectenna array is tested in the X band frequency range.

The Use of Pediatric Ventricular Assist Devices in Children's Hospitals From 2000 to 2010: Morbidity, Mortality, and Hospital Charges.

Science.gov (United States)

Mansfield, Robert T; Lin, Kimberly Y; Zaoutis, Theoklis; Mott, Antonio R; Mohamad, Zeinab; Luan, Xianqun; Kaufman, Beth D; Ravishankar, Chitra; Gaynor, J William; Shaddy, Robert E; Rossano, Joseph W

2015-07-01

The use of ventricular assist devices has increased dramatically in adult heart failure patients. However, the overall use, outcome, comorbidities, and resource utilization of ventricular assist devices in pediatric patients have not been well described. We sought to demonstrate that the use of ventricular assist devices in pediatric patients has increased over time and that mortality has decreased. A retrospective study of the Pediatric Health Information System database was performed for patients 20 years old or younger undergoing ventricular assist device placement from 2000 to 2010. None. Four hundred seventy-five pediatric patients were implanted with ventricular assist devices during the study period: 69 in 2000-2003 (era 1), 135 in 2004-2006 (era 2), and 271 in 2007-2010 (era 3). Median age at ventricular assist device implantation was 6.0 years (interquartile range, 0.5-13.8), and the proportion of children who were 1-12 years old increased from 29% in era 1 to 47% in era 3 (p = 0.002). The majority of patients had a diagnosis of cardiomyopathy; this increased from 52% in era 1 to 72% in era 3 (p = 0.003). Comorbidities included arrhythmias (48%), pulmonary hypertension (16%), acute renal failure (34%), cerebrovascular disease (28%), and sepsis/systemic inflammatory response syndrome (34%). Two hundred forty-seven patients (52%) underwent heart transplantation and 327 (69%) survived to hospital discharge. Hospital mortality decreased from 42% in era 1 to 25% in era 3 (p = 0.004). Median hospital length of stay increased (37 d [interquartile range, 12-64 d] in era 1 vs 69 d [interquartile range, 35-130] in era 3; p interquartile range, $227,052-$853,318] in era 1 vs $1,577,983 [interquartile range, $874,463-$2,280,435] in era 3; p < 0.001). Factors associated with increased mortality include age less than 1 year (odds ratio, 2.04; 95% CI, 1.01-3.83), acute renal failure (odds ratio, 2.1; 95% CI, 1.26-3.65), cerebrovascular disease (odds ratio, 2.1; 95% CI, 1

Wearable Assistive Devices for the Blind

OpenAIRE

Velazquez, Ramiro

2016-01-01

Assistive devices are a key aspect in wearable systems for biomedical applications, as they represent potential aids for people with physical and sensory disabilities that might lead to improvements in the quality of life. This chapter focuses on wearable assistive devices for the blind. It intends to review the most significant work done in this area, to present the latest approaches for assisting this population and to understand universal design concepts for the development of wearable ass...

Investigational Clinical Trial of a Prototype Optoelectronic Computer-Aided Navigation Device for Dental Implant Surgery.

Science.gov (United States)

Jokstad, Asbjørn; Winnett, Brenton; Fava, Joseph; Powell, David; Somogyi-Ganss, Eszter

New digital technologies enable real-time computer-aided (CA) three-dimensional (3D) guidance during dental implant surgery. The aim of this investigational clinical trial was to demonstrate the safety and effectiveness of a prototype optoelectronic CA-navigation device in comparison with the conventional approach for planning and effecting dental implant surgery. Study participants with up to four missing teeth were recruited from the pool of patients referred to the University of Toronto Graduate Prosthodontics clinic. The first 10 participants were allocated to either a conventional or a prototype device study arm in a randomized trial. The next 10 participants received implants using the prototype device. All study participants were restored with fixed dental prostheses after 3 (mandible) or 6 (maxilla) months healing, and monitored over 12 months. The primary outcome was the incidence of any surgical, biologic, or prosthetic adverse events or device-related complications. Secondary outcomes were the incidence of positioning of implants not considered suitable for straightforward prosthetic restoration (yes/no); the perception of the ease of use of the prototype device by the two oral surgeons, recorded by use of a Likert-type questionnaire; and the clinical performance of the implant and superstructure after 1 year in function. Positioning of the implants was appraised on periapical radiographs and clinical photographs by four independent blinded examiners. Peri-implant bone loss was measured on periapical radiographs by a blinded examiner. No adverse events occurred related to placing any implants. Four device-related complications led to a switch from using the prototype device to the conventional method. All implants placed by use of the prototype device were in a position considered suitable for straightforward prosthetic restoration (n = 21). The qualitative evaluation by the surgeons was generally positive, although ergonomic challenges were identified

Biomedical Impact in Implantable Devices-The Transcatheter Aortic Valve as an example

Science.gov (United States)

Anastasiou, Alexandros; Saatsakis, George

2015-09-01

Objective: To update of the scientific community about the biomedical engineering involvement in the implantable devices chain. Moreover the transcatheter Aortic Valve (TAV) replacement, in the field of cardiac surgery, will be analyzed as an example of contemporary implantable technology. Methods: A detailed literature review regarding biomedical engineers participating in the implantable medical product chain, starting from the design of the product till the final implantation technique. Results: The scientific role of biomedical engineers has clearly been established. Certain parts of the product chain are implemented almost exclusively by experienced biomedical engineers such as the transcatheter aortic valve device. The successful professional should have a multidisciplinary knowledge, including medicine, in order to pursue the challenges for such intuitive technology. This clearly indicates that biomedical engineers are among the most appropriate scientists to accomplish such tasks. Conclusions: The biomedical engineering involvement in medical implantable devices has been widely accepted by the scientific community, worldwide. Its important contribution, starting from the design and extended to the development, clinical trials, scientific support, education of other scientists (surgeons, cardiologists, technicians etc.), and even to sales, makes biomedical engineers a valuable player in the scientific arena. Notably, the sector of implantable devices is constantly raising, as emerging technologies continuously set up new targets.

Identification of non-HLA antibodies in ventricular assist device recipients

Directory of Open Access Journals (Sweden)

Sandy von Salisch

2013-11-01

Full Text Available Aims Recipients of ventricular assist devices (VADR have a higher incidence to develop antibodies (Abs against human leukocyte antigens (HLA. Non-HLA antibodies like major histocompatibility complex class I-related chain A (MICA and autoantibodies against angiotensin type 1 receptor (AT1R and endothelin receptor A (ETAR are also implicated in the pathogenesis of acute rejection and allograft vasculopathy. We monitored non-HLA- and HLA-Abs in VADR up to one year after implantation. Materials and methods Sera of 56 VADR (54.1±12.8 years old, 50 men were analyzed for Abs against HLA-, MICA-, AT1R- and ETAR several times over one year after implantation using ELISA and Luminex xMAP technology. Blood transfusions, gender and age were reviewed. Results Sera of 56 VADR (54.1±12.8 years old, 50 men were analyzed for Abs against HLA-, MICA-, AT1R- and ETAR several times over one year after implantation using ELISA and Luminex xMAP technology. Blood transfusions, gender and age were reviewed. Conclusion Beside HLA- and MICA-Abs, VADR showed high titres of Abs against AT1R or ETAR, which underlines the necessity for monitoring non-HLA antibodies in VADR prior heart transplantation.

Pain-only complaint about cochlear implant device: A five-patient pediatric experience.

Science.gov (United States)

Todd, Norman Wendell; Fainberg, Jolie C; Ukatu, CeIsha Chinwe; Venable, Claudia Y; Segel, Phil

2015-09-01

To present the case histories and management of five pediatric patients who experienced pain at the receiver-stimulator site, but no other indication that the device was failing. Patients were from a sole-surgeon pediatric practice (600 + implant surgeries before June 2013; about even proportions of Advanced Bionics, Cochlear Corporation, and MED-EL devices). The University Institutional Review Board-approved review of sole-surgeon pediatric case series. The onset of pain ranged from 2 to 16 years post implantation. Pain, not amenable to conventional medical therapy, was present regardless of whether or not the external appliance was 'on', or even being worn on the head. Four of the five patients were bilaterally implanted, but pain was only at one receiver-stimulator package. Clinical management ultimately included revision surgery in all five cases, with immediate resolution of the pain in four. For those four, the replacement cochlear implant (CI) performed well; the other patient fears pain if her replacement device is used, but continues enjoying her contralateral implant. At analysis by the company, two of five explanted devices exhibited problems: loss of hermeticity; insulation failure. Though infrequently reported, pain-only complaint by a CI user is a challenging dilemma. Pain may be the sole clinical manifestation of cochlear implant device failure. We offer a flowchart for the care of CI patients with pain, encourage a worldwide registry of such cases, and offer ideas to try to understand better the problem.

Hearing improvement with softband and implanted bone-anchored hearing devices and modified implantation surgery in patients with bilateral microtia-atresia.

Science.gov (United States)

Wang, Yibei; Fan, Xinmiao; Wang, Pu; Fan, Yue; Chen, Xiaowei

2018-01-01

To evaluate auditory development and hearing improvement in patients with bilateral microtia-atresia using softband and implanted bone-anchored hearing devices and to modify the implantation surgery. The subjects were divided into two groups: the softband group (40 infants, 3 months to 2 years old, Ponto softband) and the implanted group (6 patients, 6-28 years old, Ponto). The Infant-Toddler Meaning Auditory Integration Scale was used conducted to evaluate auditory development at baseline and after 3, 6, 12, and 24 months, and visual reinforcement audiometry was used to assess the auditory threshold in the softband group. In the implanted group, bone-anchored hearing devices were implanted combined with the auricular reconstruction surgery, and high-resolution CT was used to assess the deformity preoperatively. Auditory threshold and speech discrimination scores of the patients with implants were measured under the unaided, softband, and implanted conditions. Total Infant-Toddler Meaning Auditory Integration Scale scores in the softband group improved significantly and approached normal levels. The average visual reinforcement audiometry values under the unaided and softband conditions were 76.75 ± 6.05 dB HL and 32.25 ± 6.20 dB HL (P hearing devices is effective for auditory development and hearing improvement in infants with bilateral microtia-atresia. Wearing softband bone-anchored hearing devices before auricle reconstruction and combining bone-anchored hearing device implantation with auricular reconstruction surgery may bethe optimal clinical choice for these patients, and results in more significant hearing improvement and minimal surgical and anesthetic injury. Copyright © 2017 Elsevier B.V. All rights reserved.

Low Power Design for Future Wearable and Implantable Devices

DEFF Research Database (Denmark)

Lundager, Katrine; Zeinali, Behzad; Tohidi, Mohammad

2016-01-01

limit, which is a critical limit for further miniaturization to develop smaller and smarter wearable/implantable devices (WIDs), especially for multi-task continuous computing purposes. Developing smaller and smarter devices with more functionality requires larger batteries, which are currently the main...

[Guided and computer-assisted implant surgery and prosthetic: The continuous digital workflow].

Science.gov (United States)

Pascual, D; Vaysse, J

2016-02-01

New continuous digital workflow protocols of guided and computer-assisted implant surgery improve accuracy of implant positioning. The design of the future prosthesis is based on the available prosthetic space, gingival height and occlusal relationship with the opposing and adjacent teeth. The implant position and length depend on volume, density and bone quality, gingival height, tooth-implant and implant-implant distances, implant parallelism, axis and type of the future prosthesis. The crown modeled on the software will therefore serve as a guide to the future implant axis and not the reverse. The guide is made by 3D printing. The software determines surgical protocol with the drilling sequences. The unitary or plural prosthesis, modeled on the software and built before surgery, is loaded directly after implant placing, if needed. These protocols allow for a full continuity of the digital workflow. The software provides the surgeon and the dental technician a total freedom for the prosthetic-surgery guide design and the position of the implants. The prosthetic project, occlusal and aesthetic, taking the bony and surgical constraints into account, is optimized. The implant surgery is simplified and becomes less "stressful" for the patient and the surgeon. Guided and computer-assisted surgery with continuous digital workflow is becoming the technique of choice to improve the accuracy and quality of implant rehabilitation. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

"Real life" longevity of implantable cardioverter-defibrillator devices.

Science.gov (United States)

Manolis, Antonis S; Maounis, Themistoklis; Koulouris, Spyridon; Vassilikos, Vassilios

2017-09-01

Manufacturers of implantable cardioverter-defibrillators (ICDs) promise a 5- to 9-year projected longevity; however, real-life data indicate otherwise. The aim of the present study was to assess ICD longevity among 685 consecutive patients over the last 20 years. Real-life longevity of ICDs may differ from that stated by the manufacturers. The study included 601 men and 84 women (mean age, 63.1 ± 13.3 years). The underlying disease was coronary (n = 396) or valvular (n = 15) disease, cardiomyopathy (n = 220), or electrical disease (n = 54). The mean ejection fraction was 35%. Devices were implanted for secondary (n = 562) or primary (n = 123) prevention. Single- (n = 292) or dual-chamber (n = 269) or cardiac resynchronization therapy (CRT) devices (n = 124) were implanted in the abdomen (n = 17) or chest (n = 668). Over 20 years, ICD pulse generator replacements were performed in 238 patients (209 men; age 63.7 ± 13.9 years; ejection fraction, 37.7% ± 14.0%) who had an ICD for secondary (n = 210) or primary (n = 28) prevention. The mean ICD longevity was 58.3 ± 18.7 months. In 20 (8.4%) patients, devices exhibited premature battery depletion within 36 months. Most (94%) patients had none, minor, or modest use of ICD therapy. Longevity was longest for single-chamber devices and shortest for CRT devices. Latest-generation devices replaced over the second decade lasted longer compared with devices replaced during the first decade. When analyzed by manufacturer, Medtronic devices appeared to have longer longevity by 13 to 18 months. ICDs continue to have limited longevity of 4.9 ± 1.6 years, and 8% demonstrate premature battery depletion by 3 years. CRT devices have the shortest longevity (mean, 3.8 years) by 13 to 17 months, compared with other ICD devices. These findings have important implications, particularly in view of the high expense involved with this type of electrical

Development of industrial ion implantation and ion assisted coating processes: A perspective

International Nuclear Information System (INIS)

Legg, K.O.; Solnick-Legg, H.

1989-01-01

Ion beam processes have gone through a series of developmental stages, from being the mainstay of the semiconductor industry for production of integrated circuits, to new commercial processes for biomedical, aerospace and other industries. Although research is still continuing on surface modification using ion beam methods, ion implantation and ion assisted coatings for treatment of metals, ceramics, polymers and composites must now be considered viable industrial processes of benefit in a wide variety of applications. However, ion implantation methods face various barriers to acceptability, in terms not only of other surface treatment processes, but for implantation itself. This paper will discuss some of the challenges faced by a small company whose primary business is development and marketing of ion implantation and ion-assisted coating processes. (orig.)

[Radiotherapy and implantable medical device: example of infusion pumps].

Science.gov (United States)

Abrous-Anane, S; Benhassine, S; Lopez, S; Cristina, K; Mazeron, J-J

2013-12-01

Indication for radiotherapy is often questioned for patients equipped with implantable medical devices like infusion pumps as the radiation tolerance is poor or not known. We report here on the case of a patient who we treated with pelvic radiotherapy for cervical cancer and who had an infusion pump in iliac fossa. We conducted a series of tests on five identical pumps that insured that the treatment protocol is harmless to the implanted device. Copyright © 2013 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

Implant-assisted removable partial dentures: practical considerations.

Science.gov (United States)

Omura, Aaron J; Latthe, Vaibhav; Marin, Mark M; Cagna, David R

2016-01-01

At the heart of prosthodontic treatment planning must be a sound understanding of the quality and reliability of the prosthodontic foundation. Implant prosthodontics relies almost entirely on the biological and mechanical properties of an osseous foundation. Initiation of therapy in the absence of a healthy and stable prosthodontic foundation risks unintended and suboptimal treatment outcomes. For conventional removable partial denture (RPD) therapy, consideration must be given to interactions between the soft and hard tissues available to support and stabilize planned prostheses. The strategic addition of implants to the partially edentulous foundation can improve the support, comfort, and esthetics of an RPD, resulting in elevated patient satisfaction and greater therapeutic success. This article discusses aspects of diagnosis, treatment planning, clinical management, laboratory execution, and maintenance that must be considered in order to obtain optimal results with implant-assisted RPDs.

A comparison of the health status and psychological distress of partners of patients with a left ventricular assist device versus an implantable cardioverter defibrillator

DEFF Research Database (Denmark)

Brouwers, Corline; Caliskan, Kadir; de Jonge, Nicolaas

2014-01-01

(F = 10.71, p = .001) but poorer mental health status (F = 14.82, p depression scores compared to ICD partners (F = 3.68, p = .05) at 6 months follow-up, also in adjusted analyses. There was no significant difference between groups on anxiety. CONCLUSION: Caregivers of LVAD......OBJECTIVE: To examine if the caregiving for patients with a left ventricular assist device (LVAD) is related to a poorer health status and more distress compared to patients with an implantable cardioverter defibrillator (ICD). BACKGROUND: Partners distress may influence patient outcomes...... and is therefore an important aspect in the care of LVAD and ICD patients. METHODS: Multi-center prospective observational study with 6 months follow-up of 33 LVAD partners (27% men; mean age = 54 ± 10 years) and 414 ICD partners (22% men; mean age = 60 ± 12 years). RESULTS: LVAD partners reported better physical...

Proximal thoracic aorta dimensions after continuous-flow left ventricular assist device implantation: Longitudinal changes and relation to aortic valve insufficiency.

Science.gov (United States)

Fine, Nowell M; Park, Soon J; Stulak, John M; Topilsky, Yan; Daly, Richard C; Joyce, Lyle D; Pereira, Naveen L; Schirger, John A; Edwards, Brooks S; Lin, Grace; Kushwaha, Sudhir S

2016-04-01

In this study we examined the impact of continuous-flow left ventricular assist device (CF-LVAD) support on proximal thoracic aorta dimensions. Aortic root and ascending aorta diameter were measured from serial echocardiograms before and after CF-LVAD implantation in patients with ≥6 months of support, and correlated with the development of >mild aortic valve insufficiency (AI). Of 162 patients included, mean age was 58 ± 11 years and 128 (79%) were male. Seventy-nine (63%) were destination therapy patients. Mean aortic root and ascending aorta diameters at baseline, 1 month, 6 months, 12 months and long-term follow-up (mean 2.0 ± 1.4 years) were 3.5 ± 0.4, 3.5 ± 0.3, 3.9 ± 0.3, 3.9 ± 0.2 and 4.0 ± 0.3, and 3.3 ± 0.2, 3.3 ± 0.3, 3.6 ± 0.2, 3.6 ± 0.3 and 3.6 ± 0.3 cm, respectively. Only change in aortic root diameter from 1-month to 6-month follow-up reached statistical significance (p = 0.03). Nine (6%) patients had accelerated proximal thoracic aorta expansion (>0.5 cm/year), occurring predominantly in the first 6 months after implantation. These patients were older and more likely to have hypertension and baseline proximal thoracic aorta dilation. Forty-five (28%) patients developed >mild AI at long-term follow-up, including 7 of 9 (78%) of those with accelerated proximal thoracic aorta expansion. All 7 had aortic valves that remained closed throughout the cardiac cycle, and this, along with duration of CF-LVAD support and increase in aortic root diameter, were significantly associated with developing >mild AI. CF-LVAD patients have small increases in proximal thoracic aorta dimensions that predominantly occur within the first 6 months after implantation and then stabilize. Increasing aortic root diameter was associated with AI development. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

A survey of cardiac implantable electronic device implantation in India: By Indian Society of Electrocardiology and Indian Heart Rhythm Society

Directory of Open Access Journals (Sweden)

Jayaprakash Shenthar

2016-01-01

Conclusion: A large proportion of CIED implants in India are PM for bradyarrhythmic indications, predominantly AV block. ICD's are implanted almost equally for primary and secondary prophylaxis. Most CRT devices are implanted for NYHA Class III. There is a male predominance for implantation of CIED.

Identification of Bodies by Unique Serial Numbers on Implanted Medical Devices.

Science.gov (United States)

Blessing, Melissa M; Lin, Peter T

2018-05-01

Visual identification is the most common identification method used by medical examiners but is not always possible. Alternative methods include X-ray, fingerprint, or DNA comparison, but these methods require additional resources. Comparison of serial numbers on implanted medical devices is a rapid and definitive method of identification. To assess the practicality of using this method, we reviewed 608 consecutive forensic autopsies performed at a regional medical examiner office. Of these, 56 cases required an alternative method of identification due to decomposition (n = 35), gunshot wound (n = 9), blunt trauma (n = 6), or charring (n = 6). Of these 56 cases, eight (14.3%) were known to have an implanted medical device. Of these eight cases, five (63%) could be positively identified by comparing serial numbers. If an implanted medical device is known to be present, and medical records are available, identification by medical device serial number should be a first-line method. © 2017 American Academy of Forensic Sciences.

New orthopaedic implant management tool for computer-assisted planning, navigation, and simulation: from implant CAD files to a standardized XML-based implant database.

Science.gov (United States)

Sagbo, S; Blochaou, F; Langlotz, F; Vangenot, C; Nolte, L-P; Zheng, G

2005-01-01

Computer-Assisted Orthopaedic Surgery (CAOS) has made much progress over the last 10 years. Navigation systems have been recognized as important tools that help surgeons, and various such systems have been developed. A disadvantage of these systems is that they use non-standard formalisms and techniques. As a result, there are no standard concepts for implant and tool management or data formats to store information for use in 3D planning and navigation. We addressed these limitations and developed a practical and generic solution that offers benefits for surgeons, implant manufacturers, and CAS application developers. We developed a virtual implant database containing geometrical as well as calibration information for orthopedic implants and instruments, with a focus on trauma. This database has been successfully tested for various applications in the client/server mode. The implant information is not static, however, because manufacturers periodically revise their implants, resulting in the deletion of some implants and the introduction of new ones. Tracking these continuous changes and keeping CAS systems up to date is a tedious task if done manually. This leads to additional costs for system development, and some errors are inevitably generated due to the huge amount of information that has to be processed. To ease management with respect to implant life cycle, we developed a tool to assist end-users (surgeons, hospitals, CAS system providers, and implant manufacturers) in managing their implants. Our system can be used for pre-operative planning and intra-operative navigation, and also for any surgical simulation involving orthopedic implants. Currently, this tool allows addition of new implants, modification of existing ones, deletion of obsolete implants, export of a given implant, and also creation of backups. Our implant management system has been successfully tested in the laboratory with very promising results. It makes it possible to fill the current gap

Wireless communication with implanted medical devices using the conductive properties of the body.

Science.gov (United States)

Ferguson, John E; Redish, A David

2011-07-01

Many medical devices that are implanted in the body use wires or wireless radiofrequency telemetry to communicate with circuitry outside the body. However, the wires are a common source of surgical complications, including breakage, infection and electrical noise. In addition, radiofrequency telemetry requires large amounts of power and results in low-efficiency transmission through biological tissue. As an alternative, the conductive properties of the body can be used to enable wireless communication with implanted devices. In this article, several methods of intrabody communication are described and compared. In addition to reducing the complications that occur with current implantable medical devices, intrabody communication can enable novel types of miniature devices for research and clinical applications.

Implantable optical-electrode device for stimulation of spinal motoneurons

International Nuclear Information System (INIS)

Matveev, M V; Erofeev, A I; Zakharova, O A; Vlasova, O L; Pyatyshev, E N; Kazakin, A N

2016-01-01

Recent years, optogenetic method of scientific research has proved its effectiveness in the nerve cell stimulation tasks. In our article we demonstrate an implanted device for the spinal optogenetic motoneurons activation. This work is carried out in the Laboratory of Molecular Neurodegeneration of the Peter the Great St. Petersburg Polytechnic University, together with Nano and Microsystem Technology Laboratory. The work of the developed device is based on the principle of combining fiber optic light stimulation of genetically modified cells with the microelectrode multichannel recording of neurons biopotentials. The paper presents a part of the electrode implant manufacturing technique, combined with the optical waveguide of ThorLabs (USA). (paper)

Exercise physiology, testing, and training in patients supported by a left ventricular assist device.

Science.gov (United States)

Loyaga-Rendon, Renzo Y; Plaisance, Eric P; Arena, Ross; Shah, Keyur

2015-08-01

The left ventricular assist device (LVAD) is an accepted treatment alternative for the management of end-stage heart failure. As we move toward implantation of LVADs in less severe cases of HF, scrutiny of functional capacity and quality of life becomes more important. Patients demonstrate improvements in exercise capacity after LVAD implantation, but the effect is less than predicted. Exercise training produces multiple beneficial effects in heart failure patients, which would be expected to improve quality of life. In this review, we describe factors that are thought to participate in the persistent exercise impairment in LVAD-supported patients, summarize current knowledge about the effect of exercise training in LVAD-supported patients, and suggest areas for future research. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Total Artificial Heart Implantation Blood Pressure Management as Resolving Treatment for Massive Hemolysis following Total Artificial Heart Implantation.

Science.gov (United States)

Ghodsizad, Ali; Koerner, Michael M; El-Banayosy, A; Zeriouh, Mohamed; Ruhparwar, Arjang; Loebe, Matthias

2016-10-21

The SynCardia Total Artificial Heart (TAH) has been used for patients with biventricular failure, who cannot be managed with implantation of a left ventricular (LV) assist device. Following TAH implantation, our patient developed severe hemolysis, which could only be managed successfully by aggressive blood pressure control [Ohashi 2003; Nakata 1998].

78 FR 2647 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant

Science.gov (United States)

2013-01-14

.... FDA-2012-N-0677] Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant AGENCY: Food...) is proposing to reclassify the blade- form endosseous dental implant, a preamendments class III... proposing to revise the classification of blade-form endosseous dental implants. DATES: Submit either...

Use of Ventricular Assist Device in Univentricular Physiology: The Role of Lumped Parameter Models.

Science.gov (United States)

Di Molfetta, Arianna; Ferrari, Gianfranco; Filippelli, Sergio; Fresiello, Libera; Iacobelli, Roberta; Gagliardi, Maria G; Amodeo, Antonio

2016-05-01

Failing single-ventricle (SV) patients might benefit from ventricular assist devices (VADs) as a bridge to heart transplantation. Considering the complex physiopathology of SV patients and the lack of established experience, the aim of this work was to realize and test a lumped parameter model of the cardiovascular system, able to simulate SV hemodynamics and VAD implantation effects. Data of 30 SV patients (10 Norwood, 10 Glenn, and 10 Fontan) were retrospectively collected and used to simulate patients' baseline. Then, the effects of VAD implantation were simulated. Additionally, both the effects of ventricular assistance and cavopulmonary assistance were simulated in different pathologic conditions on Fontan patients, including systolic dysfunction, diastolic dysfunction, and pulmonary vascular resistance increment. The model can reproduce patients' baseline well. Simulation results suggest that the implantation of VAD: (i) increases the cardiac output (CO) in all the three palliation conditions (Norwood 77.2%, Glenn 38.6%, and Fontan 17.2%); (ii) decreases the SV external work (SVEW) (Norwood 55%, Glenn 35.6%, and Fontan 41%); (iii) increases the mean pulmonary arterial pressure (Pap) (Norwood 39.7%, Glenn 12.1%, and Fontan 3%). In Fontan circulation, with systolic dysfunction, the left VAD (LVAD) increases CO (35%), while the right VAD (RVAD) determines a decrement of inferior vena cava pressure (Pvci) (39%) with 34% increment of CO. With diastolic dysfunction, the LVAD increases CO (42%) and the RVAD decreases the Pvci. With pulmonary vascular resistance increment, the RVAD allows the highest CO (50%) increment with the highest decrement of Pvci (53%). The single ventricular external work (SVEW) increases (decreases) increasing the VAD speed in cavopulmonary (ventricular) assistance. Numeric models could be helpful in this challenging and innovative field to support patients and VAD selection to optimize the clinical outcome and personalize the therapy

- LAA Occluder View for post-implantation Evaluation (LOVE) - standardized imaging proposal evaluating implanted left atrial appendage occlusion devices by cardiac computed tomography

International Nuclear Information System (INIS)

Behnes, Michael; Akin, Ibrahim; Sartorius, Benjamin; Fastner, Christian; El-Battrawy, Ibrahim; Borggrefe, Martin; Haubenreisser, Holger; Meyer, Mathias; Schoenberg, Stefan O.; Henzler, Thomas

2016-01-01

A standardized imaging proposal evaluating implanted left atrial appendage (LAA) occlusion devices by cardiac computed tomography angiography (cCTA) has never been investigated. cCTA datasets were acquired on a 3 rd generation dual-source CT system and reconstructed with a slice thickness of 0.5 mm. An interdisciplinary evaluation was performed by two interventional cardiologists and one radiologist on a 3D multi-planar workstation. A standardized multi-planar reconstruction algorithm was developed in order to assess relevant clinical aspects of implanted LAA occlusion devices being outlined within a pictorial essay. The following clinical aspects of implanted LAA occlusion devices were evaluated within the most appropriate cCTA multi-planar reconstruction: (1) topography to neighboring structures, (2) peri-device leaks, (3) coverage of LAA lobes, (4) indirect signs of neo-endothelialization. These are illustrated within concise CT imaging examples emphasizing the potential value of the proposed cCTA imaging algorithm: Starting from anatomical cCTA planes and stepwise angulation planes perpendicular to the base of the LAA devices generates an optimal LAA Occluder View for post-implantation Evaluation (LOVE). Aligned true axial, sagittal and coronal LOVE planes offer a standardized and detailed evaluation of LAA occlusion devices after percutaneous implantation. This pictorial essay presents a standardized imaging proposal by cCTA using multi-planar reconstructions that enables systematical follow-up and comparison of patients after LAA occlusion device implantation. The online version of this article (doi:10.1186/s12880-016-0127-y) contains supplementary material, which is available to authorized users

Experience With a Long-term Pulsatile Ventricular Assist Device as a Bridge to Heart Transplant in Adults.

Science.gov (United States)

Gómez Bueno, Manuel; Segovia Cubero, Javier; Serrano Fiz, Santiago; Ugarte Basterrechea, Juan; Hernández Pérez, Francisco José; Goirigolzarri Artaza, Josebe; Castedo Mejuto, Evaristo; Burgos Lázaro, Raúl; García Montero, Carlos; Moñivas Palomero, Vanessa; Mingo Santos, Susana; González Román, Ana Isabel; Álvarez Avelló, José Manuel; Vidal Fernández, Mercedes; Forteza Gil, Alberto; Alonso-Pulpón, Luis

2017-09-01

Most long-term ventricular assist devices (VADs) that are currently implanted are intracorporeal continuous-flow devices. Their main limitations include their high cost and inability to provide biventricular support. The aim of this study was to describe the results of using paracorporeal pulsatile-flow VADs as a bridge to transplant (BTT) in adult patients. Retrospective analysis of the characteristics, complications, and outcomes of a single-center case series of consecutive patients treated with the EXCOR VAD as BTT between 2009 and 2015. During the study period, 25 VADs were implanted, 6 of them biventricular. Ventricular assist devices were indicated directly as a BTT in 12 patients and as a bridge to decision in 13 due to the presence of potentially reversible contraindications or chance of heart function recovery. Twenty patients (80%) were successfully bridged to heart transplant after a median of 112 days (range, 8-239). The main complications included infectious (52% of patients), neurological events (32%, half of them fatal), bleeding (28%), and VAD malfunction requiring component replacement (28%). Eighty percent of patients with the EXCOR VAD as BTT achieved the goal after an average of almost 4 months of support. The most frequent complications were infectious, and the most severe were neurological. In our enivonment, the use of these pulsatile-flow VAD as BTT is a feasible strategy that obtains similar outcomes to those of intracorporeal continuous-flow devices. Copyright © 2016 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Percutaneous Implantation of A Parachute Device For Treatment of Ischemic Heart Failure

Energy Technology Data Exchange (ETDEWEB)

Cilingiroglu, Mehmet, E-mail: mcilingiroglu@yahoo.com; Rollefson, William A.; Mego, David

2013-07-15

Congestive heart failure (CHF) secondary to ischemic cardiomyopathy is associated with significant morbidity and mortality despite currently available medical therapy. The Parachute{sup TM} device is a novel left ventricular partitioning device that is delivered percutaneously in the left ventricle (LV) in patients with anteroapical regional wall motion abnormalities, dilated LV and systolic dysfunction after anterior myocardial infarction with favorable clinical and LV hemodynamic improvements post-implantation. Here, we do review the current literature and present a case of the Parachute device implantation.

Percutaneous Implantation of A Parachute Device For Treatment of Ischemic Heart Failure

International Nuclear Information System (INIS)

Cilingiroglu, Mehmet; Rollefson, William A.; Mego, David

2013-01-01

Congestive heart failure (CHF) secondary to ischemic cardiomyopathy is associated with significant morbidity and mortality despite currently available medical therapy. The Parachute TM device is a novel left ventricular partitioning device that is delivered percutaneously in the left ventricle (LV) in patients with anteroapical regional wall motion abnormalities, dilated LV and systolic dysfunction after anterior myocardial infarction with favorable clinical and LV hemodynamic improvements post-implantation. Here, we do review the current literature and present a case of the Parachute device implantation

Current State and Future Perspectives of Energy Sources for Totally Implantable Cardiac Devices.

Science.gov (United States)

Bleszynski, Peter A; Luc, Jessica G Y; Schade, Peter; PhilLips, Steven J; Tchantchaleishvili, Vakhtang

There is a large population of patients with end-stage congestive heart failure who cannot be treated by means of conventional cardiac surgery, cardiac transplantation, or chronic catecholamine infusions. Implantable cardiac devices, many designated as destination therapy, have revolutionized patient care and outcomes, although infection and complications related to external power sources or routine battery exchange remain a substantial risk. Complications from repeat battery replacement, power failure, and infections ultimately endanger the original objectives of implantable biomedical device therapy - eliminating the intended patient autonomy, affecting patient quality of life and survival. We sought to review the limitations of current cardiac biomedical device energy sources and discuss the current state and trends of future potential energy sources in pursuit of a lifelong fully implantable biomedical device.

Assistive Devices for Students with Disabilities.

Science.gov (United States)

Wisniewski, Lech; Sedlak, Robert

1992-01-01

Describes a variety of devices that can assist students with disabilities. Highlights recently developed devices for students with specific learning disabilities, and with vision, hearing, health, physical, and speech and language impairments. The devices can help rehabilitate, reeducate, facilitate normalcy, or augment current functioning. (GLR)

A wireless power transmission system for implantable devices in freely moving rodents.

Science.gov (United States)

Eom, Kyungsik; Jeong, Joonsoo; Lee, Tae Hyung; Kim, Jinhyung; Kim, Junghoon; Lee, Sung Eun; Kim, Sung June

2014-08-01

Reliable wireless power delivery for implantable devices in animals is highly desired for safe and effective experimental use. Batteries require frequent replacement; wired connections are inconvenient and unsafe, and short-distance inductive coupling requires the attachment of an exterior transmitter to the animal's body. In this article, we propose a solution by which animals with implantable devices can move freely without attachments. Power is transmitted using coils attached to the animal's cage and is received by a receiver coil implanted in the animal. For a three-dimensionally uniform delivery of power, we designed a columnar dual-transmitter coil configuration. A resonator-based inductive link was adopted for efficient long-range power delivery, and we used a novel biocompatible liquid crystal polymer substrate as the implantable receiver device. Using this wireless power delivery system, we obtain an average power transfer efficiency of 15.2% (minimum efficiency of 10% and a standard deviation of 2.6) within a cage of 15×20×15 cm3.

Assessment of Safety and Effectiveness of the Extracorporeal Continuous-Flow Ventricular Assist Device (BR16010) Use as a Bridge-to-Decision Therapy for Severe Heart Failure or Refractory Cardiogenic Shock: Study Protocol for Single-Arm Non-randomized, Uncontrolled, and Investigator-Initiated Clinical Trial.

Science.gov (United States)

Fukushima, Norihide; Tatsumi, Eisuke; Seguchi, Osamu; Takewa, Yoshiaki; Hamasaki, Toshimitsu; Onda, Kaori; Yamamoto, Haruko; Hayashi, Teruyuki; Fujita, Tomoyuki; Kobayashi, Junjiro

2018-06-08

The management of heart failure patients presenting in a moribund state remains challenging, despite significant advances in the field of ventricular assist systems. Bridge to decision involves using temporary devices to stabilize the hemodynamic state of such patients while further assessment is performed and a decision can be made regarding patient management. The purpose of this study (NCVC-BTD_01, National Cerebral and Cardiovascular Center-Bridge to Dicision_01) is to assess the safety and effectiveness of the newly developed extracorporeal continuous-flow ventricular assist system employing a disposable centrifugal pump with a hydrodynamically levitated bearing (BR16010) use as a bridge-to-decision therapy for patients with severe heart failure or refractory cardiogenic shock. NCVC-BTD_01 is a single-center, single-arm, open-label, exploratory, medical device, investigator-initiated clinical study. It is conducted at the National Cerebral and Cardiovascular Center in Japan. A total of nine patients will be enrolled in the study. The study was planned using Simon's minimax two-stage phase design. The primary endpoint is a composite of survival free of device-related serious adverse events and complications during device support. For left ventricular assistance, withdrawal of a trial device due to cardiac function recovery or exchange to other ventricular assist devices (VADs) for the purpose of bridge to transplantation (BTT) during 30 days after implantation will be considered study successes. For right ventricular assistance, withdrawal of tal device due to right ventricular function recovery within 30 days after implantation will be considered a study success. Secondary objectives include changes in brain natriuretic peptide levels (7 days after implantation of a trial device and the day of withdrawal of a trial device), period of mechanical ventricular support, changes in left ventricular ejection fraction (7 days after implantation of a trial device

Implantable devices in the electromagnetic environment

Directory of Open Access Journals (Sweden)

Luca Santini

2013-12-01

Full Text Available In the last few years we are witnessing a dramatic increase in the number of CIEDs implanted. At the same time new emitters are constantly entering the marketplace and more and more medical procedures are based on electromagnetic fields as well. Therefore, the topic of the interaction of CIEDs with the EMI is a real, actual and challenging one. In the non-medical environment several types of devices may be intentional or non-intentional sources of EMI. Most of the studies reported in literature focused on mobile phones, metal detectors, as well as on headphones or digital players, but many other instruments and tools may generate electromagnetic fields. In the medical environment most of the attention is paid to MRI and recently new PM and MRI conditional ICDs have been developed and launched in the market, but the risk of interaction is present also with ionizing radiation, electrical nerve stimulation and electrosurgery. Pacemaker/ICD manufacturers are incorporating state of the art technology to make implantable devices less susceptible to EMI. However, patients and emitter manufacturers should be aware that limitations exist and that there is not complete immunity to EMI.

Deep ion implantation for bipolar silicon devices; investigations into the use of the third dimension

International Nuclear Information System (INIS)

Mouthaan, A.J.

1986-01-01

This thesis covers various aspects of the use of deep ion implantations in digital bipolar circuits. It starts with the implications of the use of deep ion implantations for numerical process, device and circuit simulation. It shows the use of 1MeV boron and phosphorus implantations in the realization of a fully vertical IIL, here named Buried Injector Logic, which can also be used as static and dynamic memory device in several different configurations. The author presents a combined MOS-bipolar device, called the Charge Injection Device as a dynamic memory cell. Finally, deep ion implantations are used to realize a stack of photovoltaic cells that produces a multiple of the open circuit voltage of one photodiode. (Auth.)

Introduction of assistive devices: home nurses' practices and beliefs.

Science.gov (United States)

Roelands, Marc; Van Oost, Paulette; Depoorter, Anne Marie; Buysse, Ann; Stevens, Veerle

2006-04-01

This paper reports a study describing home nurses' intention and current practices regarding introducing assistive devices, and investigating whether their practice is related to social cognitive factors (attitudes, subjective norms and self-efficacy). Home nurses not only care for patients in particular medical domains, but also educate and guide them towards more independence. Patients with age-related disabilities in mobility and self-care might benefit from the use of assistive devices. A home nurse might be the first and only person to discuss the disability and use of an assistive device. Therefore, home nurses' beliefs about the introduction of assistive devices could affect their daily practices. A cross-sectional study was conducted with a convenience sample of 64 home nurses chosen from a random sample of home nursing departments. The home nurses completed a self-administered questionnaire. The Theory of Planned Behaviour framework was used to develop the social cognitive measures regarding each of the six steps distinguished in the introduction of assistive devices. Home nurses had positive attitudes and high levels of intention, subjective norm and self-efficacy towards most steps of the decision process to introduce assistive devices. In a multiple linear regression analysis, attitude and self-efficacy predicted intention to introduce assistive devices to older clients with disabilities. Intention was correlated to home nurses' current practices. The findings suggest that conditions are present to involve home nurses more explicitly in the introduction of assistive devices to their patients. Social cognitive factors should be taken into account when developing interventions that aim to support home nurses to do this.

Diode laser and periodontal regeneration-assisted management of implant complications in anterior maxilla

Directory of Open Access Journals (Sweden)

Sanjeev Kumar Salaria

2018-01-01

Full Text Available Dental implant is being considered successful if the patient is pleased with both of its functional and esthetic outcome. As implant complications (such as peri-implantitis, inappropriate implant position, wrong angulation, and implant location too close to anatomical structures have been frequently encountered in dental practice, therefore, thorough knowledge to manage such complications is the key prerequisite to prevent the failure of implant. The present case report discussed the etiology, diagnosis of early peri-implantitis, and periodontal abscess with their successful management through periodontal regeneration and diode laser-assisted therapy.

Diode Laser and Periodontal Regeneration-Assisted Management of Implant Complications in Anterior Maxilla.

Science.gov (United States)

Salaria, Sanjeev Kumar; Sharma, Isha; Brar, Navjot Kaur; Kaur, Satwant

2018-01-01

Dental implant is being considered successful if the patient is pleased with both of its functional and esthetic outcome. As implant complications (such as peri-implantitis, inappropriate implant position, wrong angulation, and implant location too close to anatomical structures) have been frequently encountered in dental practice, therefore, thorough knowledge to manage such complications is the key prerequisite to prevent the failure of implant. The present case report discussed the etiology, diagnosis of early peri-implantitis, and periodontal abscess with their successful management through periodontal regeneration and diode laser-assisted therapy.

Efficient adders for assistive devices

Directory of Open Access Journals (Sweden)

Mansi Jhamb

2017-02-01

Full Text Available The Body sensor network [IEEE 802.15] is a wireless communication network consisting of assistive devices which are of prime importance in medical applications. The delay critical and power hungry blocks in these assistive devices are designed so that they consume less power, have low latency and require a lesser area on chip. In this paper, we present a qualitative as well as a quantitative analysis of an asynchronous pipelined adder design with two latest computation completion sensing approaches based on Pseudo NMOS logic and other based on C-element. The Pseudo NMOS based completion sensing approach provides a maximum improvement of 76.92% in critical path delay at supply voltage of 1.2 V and the maximum drop in power dissipation has been observed at a supply voltage of 1.1 V which is 85.60% as compared to C-element based completion sensing approach. Even at low voltages such as 0.8 V, there is a significant improvement in speed and power which is 75.64% and 74.79% respectively. Since the adder is the most widely used component in all present day assistive devices, this analysis acts as a pointer for the application of asynchronous pipelined circuits with efficient Pseudo NMOS based completion sensing approach in low voltage/low power rehabilitative devices.

Late outcomes of subcostal exchange of the HeartMate II left ventricular assist device: a word of caution.

Science.gov (United States)

Yu, Sarah N; Takayama, Hiroo; Han, Jiho; Garan, Arthur R; Kurlansky, Paul; Yuzefpolskaya, Melana; Colombo, Paolo C; Naka, Yoshifumi; Takeda, Koji

2018-04-10

Previous studies have shown the usefulness of the subcostal exchange of the HeartMate II left ventricular assist device for device malfunction. However, long-term data are still limited. Between March 2004 and July 2017, 41 of 568 (7.2%) patients who had received a HeartMate II implant at our institution had a device exchange via a subcostal incision. We summarized early and late outcomes. Forty-one patients had a total of 48 subcostal pump exchanges. Indications for device exchange included device thrombosis (n = 31, 76%), driveline infection (n = 2, 5%) and driveline injury (n = 8, 19%). All of the procedures were successful, and there were no in-hospital deaths. A Kaplan-Meier survival curve showed 30-day and 1-year survival rates after subcostal exchange of 100% and 94.6%, respectively. However, 10 (25%) patients had left ventricular assist device-related infections following subcostal exchange that included 7 pump pocket infections and 3 driveline infections. Freedom from left ventricular assist device-related infection at 1 year after subcostal exchange was 79.3%. Thirteen (32%) patients had device malfunction due to pump thrombosis that required a 2nd device exchange. Seven patients had recurrent thrombosis. Three (7%) patients had a stroke. Freedom from device thrombosis and from a stroke event at 1 year was 74.4%. Subcostal pump exchange can be safely performed. However, there is a substantial risk of infection and recurrent thrombosis. Careful follow-up for late complications is mandatory.

Leadless Cardiac Pacemaker Implantation After Lead Extraction in Patients With Severe Device Infection.

Science.gov (United States)

Kypta, Alexander; Blessberger, Hermann; Kammler, Juergen; Lambert, Thomas; Lichtenauer, Michael; Brandstaetter, Walter; Gabriel, Michael; Steinwender, Clemens

2016-09-01

Conventional pacemaker therapy is limited by short- and long-term complications, most notably device infection. Transcatheter pacing systems (TPS) may be beneficial in this kind of patients as they eliminate the need for a device pocket and leads and thus may reduce the risk of re-infection. We assessed a novel procedure in 6 patients with severe device infection who were pacemaker dependent. After lead extraction a single chamber TPS was implanted into the right ventricle. Of the 6 patients who underwent lead extraction due to severe device infection at our institution, 3 were diagnosed with a pocket infection only, whereas the other 3 showed symptoms of both pocket and lead infection. Successful lead extraction and TPS implantation was accomplished in all patients. Four patients were bridged with a temporary pacemaker between 2 hours and 2 days after lead extraction, whereas 2 patients had the TPS implanted during the same procedure just before traditional pacemaker system removal. All patients stayed free of infection during the follow-up period of 12 weeks. An additional positron emission tomography scan was performed in each patient and indicated no signs of an infection around the TPS. Transcather pacemaker implantation was safe and feasible in 6 patients and did not result in re-infection even if implanted before removal of the infected pacemaker system within the same procedure. Therefore, implantation of a TPS may be an option for patients with severe device infection, especially in those with blocked venous access or who are pacemaker dependent. © 2016 Wiley Periodicals, Inc.

Pacemaker implantation rate after transcatheter aortic valve implantation with early and new-generation devices: a systematic review.

Science.gov (United States)

van Rosendael, Philippe J; Delgado, Victoria; Bax, Jeroen J

2018-02-06

The incidence of new-onset conduction abnormalities requiring permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) with new-generation prostheses remains debated. This systematic review analyses the incidence of PPI after TAVI with new-generation devices and evaluates the electrical, anatomical, and procedural factors associated with PPI. In addition, the incidence of PPI after TAVI with early generation prostheses was reviewed for comparison. According to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist, this systematic review screened original articles published between October 2010 and October 2017, reporting on the incidence of PPI after implantation of early and new-generation TAVI prostheses. Of the 1406 original articles identified in the first search for new-generation TAVI devices, 348 articles were examined for full text, and finally, 40 studies (n = 17 139) were included. The incidence of a PPI after the use of a new-generation TAVI prosthesis ranged between 2.3% and 36.1%. For balloon-expandable prostheses, the PPI rate remained low when using an early generation SAPIEN device (ranging between 2.3% and 28.2%), and with the new-generation SAPIEN 3 device, the PPI rate was between 4.0% and 24.0%. For self-expandable prostheses, the PPI rates were higher with the early generation CoreValve device (16.3-37.7%), and despite a reduction in PPI rates with the new Evolut R, the rates remained relatively higher (14.7-26.7%). When dividing the studies according to the highest (>26.0%) and the lowest (left ventricular outflow tract (anatomical factor), and balloon valvuloplasty and depth of implantation (procedural factors) were associated with increased risk of PPI. The rate of PPI after TAVI with new-generation devices is highly variable. Specific recommendations for implantation of each prosthesis, taking into consideration the presence of pre-existent conduction abnormalities and

Centrifuge-simulated suborbital spaceflight in subjects with cardiac implanted devices.

Science.gov (United States)

Blue, Rebecca S; Reyes, David P; Castleberry, Tarah L; Vanderploeg, James M

2015-04-01

Future commercial spaceflight participants (SFPs) with conditions requiring personal medical devices represent a unique challenge. The behavior under stress of cardiac implanted devices (CIDs) such as pacemakers is of special concern. No known data currently exist on how such devices may react to the stresses of spaceflight. We examined the responses of two volunteer subjects with CIDs to G forces in a centrifuge to evaluate how similar potential commercial SFPs might tolerate the forces of spaceflight. Two subjects, 75- and 79-yr-old men with histories of atrial fibrillation and implanted dual-lead, rate-responsive pacemakers, underwent seven centrifuge runs over 2 d. Day 1 consisted of two +Gz runs (peak = +3.5 Gz, run 2) and two +Gx runs (peak = +6.0 Gx, run 4). Day 2 consisted of three runs approximating suborbital spaceflight profiles (combined +Gx/+Gz). Data collected included blood pressures, electrocardiograms, pulse oximetry, neurovestibular exams, and postrun questionnaires regarding motion sickness, disorientation, greyout, and other symptoms. Despite both subjects' significant medical histories, neither had abnormal physiological responses. Post-spin analysis demonstrated no lead displacement, damage, or malfunction of either CID. Potential risks to SFPs with CIDs include increased arrhythmogenesis, lead displacement, and device damage. There are no known prior studies of individuals with CIDs exposed to accelerations anticipated during the dynamic phases of suborbital spaceflight. These cases demonstrate that even individuals with significant medical histories and implanted devices can tolerate the acceleration exposures of commercial spaceflight. Further investigation will determine which personal medical devices present significant risks during suborbital flight and beyond.

Security and privacy issues in implantable medical devices: A comprehensive survey.

Science.gov (United States)

Camara, Carmen; Peris-Lopez, Pedro; Tapiador, Juan E

2015-06-01

Bioengineering is a field in expansion. New technologies are appearing to provide a more efficient treatment of diseases or human deficiencies. Implantable Medical Devices (IMDs) constitute one example, these being devices with more computing, decision making and communication capabilities. Several research works in the computer security field have identified serious security and privacy risks in IMDs that could compromise the implant and even the health of the patient who carries it. This article surveys the main security goals for the next generation of IMDs and analyzes the most relevant protection mechanisms proposed so far. On the one hand, the security proposals must have into consideration the inherent constraints of these small and implanted devices: energy, storage and computing power. On the other hand, proposed solutions must achieve an adequate balance between the safety of the patient and the security level offered, with the battery lifetime being another critical parameter in the design phase. Copyright © 2015 Elsevier Inc. All rights reserved.

Ventricular fibrillation in an ambulatory patient supported by a left ventricular assist device: highlighting the ICD controversy.

Science.gov (United States)

Boilson, Barry A; Durham, Lucian A; Park, Soon J

2012-01-01

Left ventricular assist devices (LVADs) provide an effective means of managing advanced pump failure as a means of bridging to cardiac transplantation or as permanent therapy. Although ventricular arrhythmias remain common post-LVAD implantation, such therapy may allow malignant arrhythmias to be tolerated hemodynamically. This report describes the clinical findings in a patient who had likely been in a ventricular tachyarrhythmia for several days and presented in ventricular fibrillation, ambulatory, and mentating normally. This report, with previous similar reports, is additive to the body of evidence that LVADs alter the physiologic impact of ventricular arrhythmias in advanced heart failure and highlights the need for thoughtful programming of implantable cardioverter defibrillator therapies in these patients.

Sequential bilateral cochlear implantation in children: parents' perspective and device use.

NARCIS (Netherlands)

Sparreboom, M.; Leeuw, A.R.; Snik, A.F.M.; Mylanus, E.A.M.

2012-01-01

OBJECTIVE: The purpose of this study was (1) to measure parental expectations before surgery of a sequentially placed second cochlear implant and compare these results with parental observations postoperatively and (2) to measure device use of the second cochlear implant and compare to unilateral

Scaling of ion implanted Si:P single electron devices

International Nuclear Information System (INIS)

Escott, C C; Hudson, F E; Chan, V C; Petersson, K D; Clark, R G; Dzurak, A S

2007-01-01

We present a modelling study on the scaling prospects for phosphorus in silicon (Si:P) single electron devices using readily available commercial and free-to-use software. The devices comprise phosphorus ion implanted, metallically doped (n + ) dots (size range 50-500 nm) with source and drain reservoirs. Modelling results are compared to measurements on fabricated devices and discussed in the context of scaling down to few-electron structures. Given current fabrication constraints, we find that devices with 70-75 donors per dot should be realizable. We comment on methods for further reducing this number

Scaling of ion implanted Si:P single electron devices

Energy Technology Data Exchange (ETDEWEB)

Escott, C C [Centre for Quantum Computer Technology, School of Electrical Engineering and Telecommunications, UNSW, Sydney, NSW 2052 (Australia); Hudson, F E [Centre for Quantum Computer Technology, School of Electrical Engineering and Telecommunications, UNSW, Sydney, NSW 2052 (Australia); Chan, V C [Centre for Quantum Computer Technology, School of Electrical Engineering and Telecommunications, UNSW, Sydney, NSW 2052 (Australia); Petersson, K D [Centre for Quantum Computer Technology, School of Electrical Engineering and Telecommunications, UNSW, Sydney, NSW 2052 (Australia); Clark, R G [Centre for Quantum Computer Technology, School of Physics, UNSW, Sydney, 2052 (Australia); Dzurak, A S [Centre for Quantum Computer Technology, School of Electrical Engineering and Telecommunications, UNSW, Sydney, NSW 2052 (Australia)

2007-06-13

We present a modelling study on the scaling prospects for phosphorus in silicon (Si:P) single electron devices using readily available commercial and free-to-use software. The devices comprise phosphorus ion implanted, metallically doped (n{sup +}) dots (size range 50-500 nm) with source and drain reservoirs. Modelling results are compared to measurements on fabricated devices and discussed in the context of scaling down to few-electron structures. Given current fabrication constraints, we find that devices with 70-75 donors per dot should be realizable. We comment on methods for further reducing this number.

Developing an Anti-Xa-Based Anticoagulation Protocol for Patients with Percutaneous Ventricular Assist Devices.

Science.gov (United States)

Sieg, Adam; Mardis, B Andrew; Mardis, Caitlin R; Huber, Michelle R; New, James P; Meadows, Holly B; Cook, Jennifer L; Toole, J Matthew; Uber, Walter E

2015-01-01

Because of the complexities associated with anticoagulation in temporary percutaneous ventricular assist device (pVAD) recipients, a lack of standardization exists in their management. This retrospective analysis evaluates current anticoagulation practices at a single center with the aim of identifying an optimal anticoagulation strategy and protocol. Patients were divided into two cohorts based on pVAD implanted (CentriMag (Thoratec; Pleasanton, CA) / TandemHeart (CardiacAssist; Pittsburgh, PA) or Impella (Abiomed, Danvers, MA)), with each group individually analyzed for bleeding and thrombotic complications. Patients in the CentriMag/TandemHeart cohort were subdivided based on the anticoagulation monitoring strategy (activated partial thromboplastin time (aPTT) or antifactor Xa unfractionated heparin (anti-Xa) values). In the CentriMag/TandemHeart cohort, there were five patients with anticoagulation titrated based on anti-Xa values; one patient developed a device thrombosis and a major bleed, whereas another patient experienced major bleeding. Eight patients received an Impella pVAD. Seven total major bleeds in three patients and no thrombotic events were detected. Based on distinct differences between the devices, anti-Xa values, and outcomes, two protocols were created to guide anticoagulation adjustments. However, anticoagulation in patients who require pVAD support is complex with constantly evolving anticoagulation goals. The ideal level of anticoagulation should be individually determined using several coagulation laboratory parameters in concert with hemodynamic changes in the patient's clinical status, the device, and the device cannulation.

A temperature sensor implant for active implantable medical devices for in vivo subacute heating tests under MRI.

Science.gov (United States)

Silemek, Berk; Acikel, Volkan; Oto, Cagdas; Alipour, Akbar; Aykut, Zaliha Gamze; Algin, Oktay; Atalar, Ergin

2018-05-01

To introduce a temperature sensor implant (TSI) that mimics an active implantable medical device (AIMD) for animal testing of MRI heating. Computer simulations and phantom experiments poorly represent potential temperature increases. Animal experiments could be a better model, but heating experiments conducted immediately after the surgery suffer from alterations of the thermoregulatory and tissue properties during acute testing conditions. Therefore, the aim of this study was to introduce a temperature sensor implant that mimics an AIMD and capable of measuring the electrode temperature after implantation of the device without any further intervention at any time after the surgery in an animal model. A battery-operated TSI, which resembled an AIMD, was used to measure the lead temperature and impedance and the case temperature. The measured values were transmitted to an external computer via a low-power Bluetooth communication protocol. In addition to validation experiments on the phantom, a sheep experiment was conducted to test the feasibility of the system in subacute conditions. The measurements had a maximum of 0.5°C difference compared to fiber-optic temperature probes. In vivo animal experiments demonstrated feasibility of the system. An active implant, which can measure its own temperature, was proposed to investigate implant heating during MRI examinations. Magn Reson Med 79:2824-2832, 2018. © 2017 International Society for Magnetic Resonance in Medicine. © 2017 International Society for Magnetic Resonance in Medicine.

Single-Ion Implantation for the Development of Si-Based MOSFET Devices with Quantum Functionalities

Directory of Open Access Journals (Sweden)

Jeffrey C. McCallum

2012-01-01

Full Text Available Interest in single-ion implantation is driven in part by research into development of solid-state devices that exhibit quantum behaviour in their electronic or optical characteristics. Here, we provide an overview of international research work on single ion implantation and single ion detection for development of electronic devices for quantum computing. The scope of international research into single ion implantation is presented in the context of our own research in the Centre for Quantum Computation and Communication Technology in Australia. Various single ion detection schemes are presented, and limitations on dopant placement accuracy due to ion straggling are discussed together with pathways for scale-up to multiple quantum devices on the one chip. Possible future directions for ion implantation in quantum computing and communications are also discussed.

Science and technology of biocompatible thin films for implantable biomedical devices.

Energy Technology Data Exchange (ETDEWEB)

Li, W.; Kabius, B.; Auciello, O.; Materials Science Division

2010-01-01

This presentation focuses on reviewing research to develop two critical biocompatible film technologies to enable implantable biomedical devices, namely: (1) development of bioinert/biocompatible coatings for encapsulation of Si chips implantable in the human body (e.g., retinal prosthesis implantable in the human eye) - the coating involves a novel ultrananocrystalline diamond (UNCD) film or hybrid biocompatible oxide/UNCD layered films; and (2) development of biocompatible films with high-dielectric constant and microfabrication process to produce energy storage super-capacitors embedded in the microchip to achieve full miniaturization for implantation into the human body.

Electromagnetic Radiation Efficiency of Body-Implanted Devices

Science.gov (United States)

Nikolayev, Denys; Zhadobov, Maxim; Karban, Pavel; Sauleau, Ronan

2018-02-01

Autonomous wireless body-implanted devices for biotelemetry, telemedicine, and neural interfacing constitute an emerging technology providing powerful capabilities for medicine and clinical research. We study the through-tissue electromagnetic propagation mechanisms, derive the optimal frequency range, and obtain the maximum achievable efficiency for radiative energy transfer from inside a body to free space. We analyze how polarization affects the efficiency by exciting TM and TE modes using a magnetic dipole and a magnetic current source, respectively. Four problem formulations are considered with increasing complexity and realism of anatomy. The results indicate that the optimal operating frequency f for deep implantation (with a depth d ≳3 cm ) lies in the (108- 109 )-Hz range and can be approximated as f =2.2 ×107/d . For a subcutaneous case (d ≲3 cm ), the surface-wave-induced interference is significant: within the range of peak radiation efficiency (about 2 ×108 to 3 ×109 Hz ), the max-to-min ratio can reach a value of 6.5. For the studied frequency range, 80%-99% of radiation efficiency is lost due to the tissue-air wave-impedance mismatch. Parallel polarization reduces the losses by a few percent; this effect is inversely proportional to the frequency and depth. Considering the implantation depth, the operating frequency, the polarization, and the directivity, we show that about an order-of-magnitude efficiency improvement is achievable compared to existing devices.

Left ventricular assist device implantation in a patient who had previously undergone apical myectomy for hypertrophic cardiomyopathy.

Science.gov (United States)

Cho, Yang Hyun; Deo, Salil V; Topilsky, Yan; Grogan, Martha A; Park, Soon J

2012-03-01

Apical hypertrophy is a rare variant of hypertropic cardiomyopathy. These patients may present with end-stage congestive heart failure subsequent to long standing diastolic dysfunction. We report the technique for left ventricular assist device insertion in a patient with previous apical myectomy for hypertrophic cardiomyopathy. © 2012 Wiley Periodicals, Inc.

Remote Monitoring of Cardiac Implantable Electronic Devices.

Science.gov (United States)

Cheung, Christopher C; Deyell, Marc W

2018-01-08

Over the past decade, technological advancements have transformed the delivery of care for arrhythmia patients. From early transtelephonic monitoring to new devices capable of wireless and cellular transmission, remote monitoring has revolutionized device care. In this article, we review the current evolution and evidence for remote monitoring in patients with cardiac implantable electronic devices. From passive transmission of device diagnostics, to active transmission of patient- and device-triggered alerts, remote monitoring can shorten the time to diagnosis and treatment. Studies have shown that remote monitoring can reduce hospitalization and emergency room visits, and improve survival. Remote monitoring can also reduce the health care costs, while providing increased access to patients living in rural or marginalized communities. Unfortunately, as many as two-thirds of patients with remote monitoring-capable devices do not use, or are not offered, this feature. Current guidelines recommend remote monitoring and interrogation, combined with annual in-person evaluation in all cardiac device patients. Remote monitoring should be considered in all eligible device patients and should be considered standard of care. Copyright © 2018 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.

Outflow monitoring of a pneumatic ventricular assist device using external pressure sensors.

Science.gov (United States)

Kang, Seong Min; Her, Keun; Choi, Seong Wook

2016-08-25

In this study, a new algorithm was developed for estimating the pump outflow of a pneumatic ventricular assist device (p-VAD). The pump outflow estimation algorithm was derived from the ideal gas equation and determined the change in blood-sac volume of a p-VAD using two external pressure sensors. Based on in vitro experiments, the algorithm was revised to consider the effects of structural compliance caused by volume changes in an implanted unit, an air driveline, and the pressure difference between the sensors and the implanted unit. In animal experiments, p-VADs were connected to the left ventricles and the descending aorta of three calves (70-100 kg). Their outflows were estimated using the new algorithm and compared to the results obtained using an ultrasonic blood flow meter (UBF) (TS-410, Transonic Systems Inc., Ithaca, NY, USA). The estimated and measured values had a Pearson's correlation coefficient of 0.864. The pressure sensors were installed at the external controller and connected to the air driveline on the same side as the external actuator, which made the sensors easy to manage.

Electromagnetic interference of implantable cardiac devices from a shoulder massage machine.

Science.gov (United States)

Yoshida, Saeko; Fujiwara, Kousaku; Kohira, Satoshi; Hirose, Minoru

2014-09-01

Shoulder massage machines have two pads that are driven by solenoid coils to perform a per cussive massage on the shoulders. There have been concerns that such machines might create electromagnetic interference (EMI) in implantable cardiac devices because of the time-varying magnetic fields produced by the alternating current in the solenoid coils. The objective of this study was to investigate the potential EMI from one such shoulder massage machine on implantable cardiac devices. We measured the distribution profile of the magnetic field intensity around the massage machine. Furthermore, we performed an inhibition test and an asynchronous test on an implantable cardiac pacemaker using the standardized Irnich human body model. We examined the events on an implantable cardioverter-defibrillator (ICD) using a pacemaker programmer while the massage machine was in operation. The magnetic field distribution profile exhibited a peak intensity of 212 (A/m) in one of the solenoid coils. The maximal interference distance between the massage machine and the implantable cardiac pacemaker was 28 cm. Ventricular fibrillation was induced when the massage machine was brought near the electrode of the ICD and touched the Irnich human body model. It is necessary to provide a "don't use" warning on the box or the exterior of the massage machines or in the user manuals and to caution patients with implanted pacemakers about the dangers and appropriate usage of massage machines.

VENTRICLE ASSIST DEVICE: PAST, PRESENT, AND FUTURE NONPULSATILE PUMPS

Directory of Open Access Journals (Sweden)

G. Р. Itkin

2009-01-01

Full Text Available The article briefly describes the history of the non-pulsating type blood pumps for ventricular assist circulation and heart-lung machine. Disclosed the main advantages of these pumps before pulsating type, especially for implantable systems development. However, disadvantages of these pumps and the directions of minimize or eliminate ones have shown. Specific examples of our implantable centrifugal and axial pump developments are presented. Declare the ways to further improve the pumps. 

Management of antithrombotic therapy during cardiac implantable device surgery.

Science.gov (United States)

AlTurki, Ahmed; Proietti, Riccardo; Birnie, David H; Essebag, Vidal

2016-06-01

Anticoagulants are commonly used drugs that are frequently encountered during device placement. Deciding when to halt or continue the use of anticoagulants is a balance between the risks of thromboembolism versus bleeding. Patients taking warfarin with a high risk of thromboembolism should continue to take their warfarin without interruption during device placement while ensuring their international normalized ratio remains below 3. For patients who are taking warfarin and have low risk of thromboembolism, either interrupted or continued warfarin may be used, with no evidence to clearly support either strategy. There is little evidence to support continuing direct acting oral anticoagulants (DOACs) for device implantation. The timing of halting these medications depends largely on renal function. If bleeding occurs, warfarin׳s anticoagulation effect is reversible with vitamin K and activated prothrombin complex concentrate. There are no DOAC reversal agents currently available, but some are under development. Regarding antiplatelet agents, aspirin alone can be safely continued while clopidogrel alone may also be continued, but with a slightly higher bleeding risk. Dual antiplatelet therapy for bare-metal stent/drug-eluting stent implanted within 4 weeks/6 months, respectively, should be continued due to high risk of stent thrombosis; however, if they are implanted after this period, then clopidogrel can be halted 5 days before the procedure and resumed soon after, while aspirin is continued. If the patient is taking both aspirin and warfarin, aspirin should be halted 5 days prior to the procedure, while warfarin is continued.

Sudden visual loss after cardiac resynchronization therapy device implantation.

Science.gov (United States)

De Vitis, Luigi A; Marchese, Alessandro; Giuffrè, Chiara; Carnevali, Adriano; Querques, Lea; Tomasso, Livia; Baldin, Giovanni; Maestranzi, Gisella; Lattanzio, Rosangela; Querques, Giuseppe; Bandello, Francesco

2017-03-10

To report a case of sudden decrease in visual acuity possibly due to a cardiogenic embolism in a patient who underwent cardiac resynchronization therapy (CRT) device implantation. A 62-year-old man with severe left ventricular systolic dysfunction and a left bundle branch block was referred to our department because of a sudden decrease in visual acuity. Nine days earlier, he had undergone cardiac transapical implantation of a CRT device, which was followed, 2 days later, by an inflammatory reaction. The patient underwent several general and ophthalmologic examinations, including multimodal imaging. At presentation, right eye (RE) best-corrected visual acuity (BCVA) was counting fingers and RE pupil was hyporeactive. Fundus examination revealed white-centered hemorrhagic dots suggestive of Roth spots. Fluorescein angiography showed delay in vascular perfusion during early stage, late hyperfluorescence of the macula and optic disk, and peripheral perivascular leakage. The first visual field test showed complete loss of vision RE and a normal left eye. Due to suspected giant cell arteritis, temporal artery biopsy was performed. Thirty minutes after the procedure, an ischemic stroke with right hemisyndrome and aphasia occurred. The RE BCVA worsened to hands motion. Four months later, RE BCVA did not improve, despite improvement in fluorescein angiography inflammatory sign. We report a possible cardiogenic embolism secondary to undiagnosed infective endocarditis causing monocular visual loss after CRT device implantation. It remains unclear how the embolus caused severe functional damage without altering the retinal anatomical structure.

The Ventricular Assist Device in the Life of the Child: A Phenomenological Pediatric Study.

Science.gov (United States)

van Manen, Michael A

2017-05-01

What is it like for a child to live with an artificial heart? The use of some medical therapies in children requires developmental considerations, is associated with psychosocial consequences, and calls for ethical sensitivities. A critical case is the ventricular assist device (VAD), a mechanical pump used to support the functioning of a failing heart. As a pediatric therapy, the device can be used as a temporary solution for poor heart function, a bridge to transplantation or recovery, or as a destination therapy. While the mechanical-technical operation of the VAD is well understood, the clinical-technical aspects of young people living with this device are largely unexplored. Drawing on interviews of school-aged children, the aim of this phenomenological study is to explore how a VAD may structure or condition a child's meaningful experience of their world outside the hospital. The driveline of an implanted VAD is the peripheral attachment, extruding through the skin to connect the controller-power supply. The materiality of the device may be interruptive, restrictive, and disturbing to the psycho-physical being and sense of self-identity of the child as a child. And while a child equipped with a VAD is not necessarily conspicuous among other children, the child may experience the device as an exposing presence, while living with the worry of a caregiver who takes on the role not simply of parent but of watchful health professional. A phenomenological understanding of the VAD should assist parents and caregiving health professionals knowing how to deal with specific issues arising in the life of the VAD child.

Radiographic implications of procedures involving cardiac implantable electronic devices (CIEDs – Selected aspects

Directory of Open Access Journals (Sweden)

Roman Steckiewicz

2017-06-01

Full Text Available Background: Some cardiac implantable electronic device (CIED implantation procedures require the use of X-rays, which is reflected by such parameters as total fluoroscopy time (TFT and dose-area product (DAP – defined as the absorbed dose multiplied by the area irradiated. Material and Methods: This retrospective study evaluated 522 CIED implantation (424 de novo and 98 device upgrade and new lead placement procedures in 176 women and 346 men (mean age 75±11 years over the period 2012–2015. The recorded procedure-related parameters TFT and DAP were evaluated in the subgroups specified below. The group of 424 de novo procedures included 203 pacemaker (PM and 171 implantable cardioverter-defibrillator (ICD implantation procedures, separately stratified by single-chamber and dual-chamber systems. Another subgroup of de novo procedures involved 50 cardiac resynchronization therapy (CRT devices. The evaluated parameters in the group of 98 upgrade procedures were compared between 2 subgroups: CRT only and combined PM and ICD implantation procedures. Results: We observed differences in TFT and DAP values between procedure types, with PM-related procedures showing the lowest, ICD – intermediate (with values for single-chamber considerably lower than those for dual-chamber systems and CRT implantation procedures – highest X-ray exposure. Upgrades to CRT were associated with 4 times higher TFT and DAP values in comparison to those during other upgrade procedures. Cardiac resynchronization therapy de novo implantation procedures and upgrades to CRT showed similar mean values of these evaluated parameters. Conclusions: Total fluoroscopy time and DAP values correlated progressively with CIED implantation procedure complexity, with CRT-related procedures showing the highest values of both parameters. Med Pr 2017;68(3:363–374

Clinical manifestations and management of left ventricular assist device-associated infections.

Science.gov (United States)

Nienaber, Juhsien Jodi C; Kusne, Shimon; Riaz, Talha; Walker, Randall C; Baddour, Larry M; Wright, Alan J; Park, Soon J; Vikram, Holenarasipur R; Keating, Michael R; Arabia, Francisco A; Lahr, Brian D; Sohail, M Rizwan

2013-11-01

Infection is a serious complication of left ventricular assist device (LVAD) therapy. Published data regarding LVAD-associated infections (LVADIs) are limited by single-center experiences and use of nonstandardized definitions. We retrospectively reviewed 247 patients who underwent continuous-flow LVAD implantation from January 2005 to December 2011 at Mayo Clinic campuses in Minnesota, Arizona, and Florida. LVADIs were defined using the International Society for Heart and Lung Transplantation criteria. We identified 101 episodes of LVADI in 78 patients (32%) from this cohort. Mean age (± standard deviation [SD]) was 57±15 years. The majority (94%) underwent Heartmate II implantation, with 62% LVADs placed as destination therapy. The most common type of LVADIs were driveline infections (47%), followed by bloodstream infections (24% VAD related, and 22% non-VAD related). The most common causative pathogens included gram-positive cocci (45%), predominantly staphylococci, and nosocomial gram-negative bacilli (27%). Almost half (42%) of the patients were managed by chronic suppressive antimicrobial therapy. While 14% of the patients had intraoperative debridement, only 3 underwent complete LVAD removal. The average duration (±SD) of LVAD support was 1.5±1.0 years. At year 2 of follow-up, the cumulative incidence of all-cause mortality was estimated to be 43%. Clinical manifestations of LVADI vary on the basis of the type of infection and the causative pathogen. Mortality remained high despite combined medical and surgical intervention and chronic suppressive antimicrobial therapy. Based on clinical experiences, a management algorithm for LVADI is proposed to assist in the decision-making process.

Adult patient decision-making regarding implantation of complex cardiac devices: a scoping review.

Science.gov (United States)

Malecki-Ketchell, Alison; Marshall, Paul; Maclean, Joan

2017-10-01

Complex cardiac rhythm management device (CRMD) therapy provides an important treatment option for people at risk of sudden cardiac death. Despite the survival benefit, device implantation is associated with significant physical and psychosocial concerns presenting considerable challenges for the decision-making process surrounding CRMD implantation for patients and physicians. The purpose of this scoping review was to explore what is known about how adult (>16 years) patients make decisions regarding implantation of CRMD therapy. Published, peer reviewed, English language studies from 2000 to 2016 were identified in a search across eight healthcare databases. Eligible studies were concerned with patient decision-making for first time device implantation. Quality assessment was completed using the mixed methods appraisal tool for all studies meeting the inclusion criteria. The findings of eight qualitative and seven quantitative studies, including patients who accepted or declined primary or secondary sudden cardiac death prevention devices, were clustered into two themes: knowledge acquisition and the process of decision-making, exposing similarities and distinctions with the treatment decision-making literature. The review revealed some insight in to the way patients approach decision-making but also exposed a lack of clarity and research activity specific to CRMD patients. Further research is recommended to support the development and application of targeted decision support mechanisms.

Computer-assisted intraoperative visualization of dental implants. Augmented reality in medicine

International Nuclear Information System (INIS)

Ploder, O.; Wagner, A.; Enislidis, G.; Ewers, R.

1995-01-01

In this paper, a recently developed computer-based dental implant positioning system with an image-to-tissue interface is presented. On a computer monitor or in a head-up display, planned implant positions and the implant drill are graphically superimposed on the patient's anatomy. Electromagnetic 3D sensors track all skull and jaw movements; their signal feedback to the workstation induces permanent real-time updating of the virtual graphics' position. An experimental study and a clinical case demonstrates the concept of the augmented reality environment - the physician can see the operating field and superimposed virtual structures, such as dental implants and surgical instruments, without loosing visual control of the operating field. Therefore, the operation system allows visualization of CT planned implantposition and the implementation of important anatomical structures. The presented method for the first time links preoperatively acquired radiologic data, planned implant location and intraoperative navigation assistance for orthotopic positioning of dental implants. (orig.) [de

Electromyography tests in patients with implanted cardiac devices are safe regardless of magnet placement.

Science.gov (United States)

Ohira, Masayuki; Silcox, Jade; Haygood, Deavin; Harper-King, Valerie; Alsharabati, Mohammad; Lu, Liang; Morgan, Marla B; Young, Angela M; Claussen, Gwen C; King, Peter H; Oh, Shin J

2013-01-01

We compared the problems or complications associated with electrodiagnostic testing in 77 patients with implanted cardiac devices. Thirty tests were performed after magnet placement, and 47 were performed without magnet application. All electrodiagnostic tests were performed safely in all patients without any serious effect on the implanted cardiac devices with or without magnet placement. A significantly higher number of patient symptoms and procedure changes were reported in the magnet group (P magnet group patients had an approximately 11-fold greater risk of symptoms than those in the control group. Our data do not support a recommendation that magnet placement is necessary for routine electrodiagnostic testing in patients with implanted cardiac devices, as long as our general and specific guidelines are followed. Copyright © 2012 Wiley Periodicals, Inc.

Advances in bioartificial liver assist devices.

Science.gov (United States)

Patzer, J F

2001-11-01

Rapid advances in development of bioartificial liver assist devices (BLADs) are exciting clinical interest in the application of BLAD technology for support of patients with acute liver failure. Four devices (Circe Biomedical HepatAssist, Vitagen ELAD, Gerlach BELS, and Excorp Medical BLSS) that rely on hepatocytes cultured in hollow-fiber membrane technology are currently in various stages of clinical evaluation. Several alternative approaches for culture and perfusion of hepatocytes have been evaluated in preclinical, large animal models of liver failure, or at a laboratory scale. Engineering design issues with respect to xenotransplantation, BLAD perfusion, hepatocyte functionality and culture maintenance, and ultimate distribution of a BLAD to a clinical site are delineated.

Spatial memory in nonhuman primates implanted with the subdural pharmacotherapy device.

Science.gov (United States)

Ludvig, Nandor; Tang, Hai M; Baptiste, Shirn L; Stefanov, Dimitre G; Kral, John G

2015-06-01

This study investigated the possible influence of the Subdural Pharmacotherapy Device (SPD) on spatial memory in 3 adult, male bonnet macaques (Macaca radiata). The device was implanted in and above the subdural/subarachnoid space and cranium overlaying the right parietal/frontal cortex: a circuitry involved in spatial memory processing. A large test chamber, equipped with four baited and four non-baited food-ports at different locations, was used: reaches into empty food ports were counted as spatial memory errors. In this study of within-subject design, before SPD implantation (control) the animals made mean 373.3 ± 114.9 (mean ± SEM) errors in the first spatial memory test session. This value dropped to 47.7 ± 18.4 by the 8th session. After SPD implantation and alternating cycles of transmeningeal saline delivery and local cerebrospinal fluid (CSF) drainage in the implanted cortex the spatial memory error count, with the same port locations, was 33.0 ± 12.2 during the first spatial memory test session, further decreasing to 5.7 ± 3.5 by the 8th post-implantation session (Pmemory performance, which in fact included at least one completely error-free session per animal over time. The study showed that complication-free implantation and use of the SPD over the parietal and frontal cortices for months leave spatial memory processes intact in nonhuman primates. Copyright © 2015 Elsevier B.V. All rights reserved.

The biocompatibility of titanium cardiovascular devices seeded with autologous blood-derived endothelial progenitor cells: EPC-seeded antithrombotic Ti implants.

Science.gov (United States)

Achneck, Hardean E; Jamiolkowski, Ryan M; Jantzen, Alexandra E; Haseltine, Justin M; Lane, Whitney O; Huang, Jessica K; Galinat, Lauren J; Serpe, Michael J; Lin, Fu-Hsiung; Li, Madison; Parikh, Amar; Ma, Liqiao; Chen, Tao; Sileshi, Bantayehu; Milano, Carmelo A; Wallace, Charles S; Stabler, Thomas V; Allen, Jason D; Truskey, George A; Lawson, Jeffrey H

2011-01-01

Implantable and extracorporeal cardiovascular devices are commonly made from titanium (Ti) (e.g. Ti-coated Nitinol stents and mechanical circulatory assist devices). Endothelializing the blood-contacting Ti surfaces of these devices would provide them with an antithrombogenic coating that mimics the native lining of blood vessels and the heart. We evaluated the viability and adherence of peripheral blood-derived porcine endothelial progenitor cells (EPCs), seeded onto thin Ti layers on glass slides under static conditions and after exposure to fluid shear stresses. EPCs attached and grew to confluence on Ti in serum-free medium, without preadsorption of proteins. After attachment to Ti for 15 min, less than 5% of the cells detached at a shear stress of 100 dyne / cm(2). Confluent monolayers of EPCs on smooth Ti surfaces (Rq of 10 nm), exposed to 15 or 100 dyne/cm(2) for 48 h, aligned and elongated in the direction of flow and produced nitric oxide dependent on the level of shear stress. EPC-coated Ti surfaces had dramatically reduced platelet adhesion when compared to uncoated Ti surfaces. These results indicate that peripheral blood-derived EPCs adhere and function normally on Ti surfaces. Therefore EPCs may be used to seed cardiovascular devices prior to implantation to ameliorate platelet activation and thrombus formation. Copyright © 2010 Elsevier Ltd. All rights reserved.

Multicenter Evaluation of Octreotide as Secondary Prophylaxis in Patients With Left Ventricular Assist Devices and Gastrointestinal Bleeding.

Science.gov (United States)

Shah, Keyur B; Gunda, Sampath; Emani, Sitaramesh; Kanwar, Manreet K; Uriel, Nir; Colombo, Paolo C; Uber, Patricia A; Sears, Melissa L; Chuang, Joyce; Farrar, David J; Brophy, Donald F; Smallfield, George B

2017-11-01

Gastrointestinal (GI) bleeding is one of the most common complications after continuous-flow left ventricular assist device implantation. More than one third of patients with incident bleed go on to develop recurrent GI bleeding. Octreotide, a somatostatin analog, is proposed to reduce the risk of recurrent GI bleeding in this population. This multicenter, retrospective analysis evaluated 51 continuous-flow left ventricular assist device patients who received secondary prophylaxis with octreotide after their index GI bleed from 2009 to 2015. All patients had a hospitalization for GI bleed and received octreotide after discharge. Patient demographics, medical and medication history, and clinical characteristics of patients who rebled after receiving octreotide were compared with non-rebleeders. These data were also compared with matched historical control patients previously enrolled in the HMII (HeartMate II) clinical trials, none of whom received octreotide, to provide a context for the bleeding rates. Twelve patients (24%) who received secondary octreotide prophylaxis developed another GI bleed, whereas 39 (76%) did not. There were similar intergroup demographics; however, significantly more bleeders had a previous GI bleeding history before left ventricular assist device placement (33% versus 5%; P =0.02) and greater frequency of angiodysplasia confirmed during endoscopy (58% versus 23%; P =0.03). Fewer patients in this study experienced a recurrent GI bleed compared with a matched historical control group that did not receive octreotide (24% versus 43%; P =0.04). Patients with continuous-flow left ventricular assist device receiving secondary prophylaxis with octreotide had a significantly lower GI bleed recurrence compared with historical controls not treated with octreotide. Additional prospective studies are needed to confirm these data. © 2017 American Heart Association, Inc.

Implanting inequality: empirical evidence of social and ethical risks of implantable radio-frequency identification (RFID) devices.

Science.gov (United States)

Monahan, Torin; Fisher, Jill A

2010-10-01

The aim of this study was to assess empirically the social and ethical risks associated with implantable radio-frequency identification (RFID) devices. Qualitative research included observational studies in twenty-three U.S. hospitals that have implemented new patient identification systems and eighty semi-structured interviews about the social and ethical implications of new patient identification systems, including RFID implants. The study identified three primary social and ethical risks associated with RFID implants: (i) unfair prioritization of patients based on their participation in the system, (ii) diminished trust of patients by care providers, and (iii) endangerment of patients who misunderstand the capabilities of the systems. RFID implants may aggravate inequalities in access to care without any clear health benefits. This research underscores the importance of critically evaluating new healthcare technologies from the perspective of both normative ethics and empirical ethics.

Palliative medicine consultation for preparedness planning in patients receiving left ventricular assist devices as destination therapy.

Science.gov (United States)

Swetz, Keith M; Freeman, Monica R; AbouEzzeddine, Omar F; Carter, Kari A; Boilson, Barry A; Ottenberg, Abigale L; Park, Soon J; Mueller, Paul S

2011-06-01

To assess the benefit of proactive palliative medicine consultation for delineation of goals of care and quality-of-life preferences before implantation of left ventricular assist devices as destination therapy (DT). We retrospectively reviewed the cases of patients who received DT between January 15, 2009, and January 1, 2010. Of 19 patients identified, 13 (68%) received proactive palliative medicine consultation. Median time of palliative medicine consultation was 1 day before DT implantation (range, 5 days before to 16 days after). Thirteen patients (68%) completed advance directives. The DT implantation team and families reported that preimplantation discussions and goals of care planning made postoperative care more clear and that adverse events were handled more effectively. Currently, palliative medicine involvement in patients receiving DT is viewed as routine by cardiac care specialists. Proactive palliative medicine consultation for patients being considered for or being treated with DT improves advance care planning and thus contributes to better overall care of these patients. Our experience highlights focused advance care planning, thorough exploration of goals of care, and expert symptom management and end-of-life care when appropriate.

Legal, ethical, and procedural bases for the use of aseptic techniques to implant electronic devices

Science.gov (United States)

Mulcahy, Daniel M.

2013-01-01

The popularity of implanting electronic devices such as transmitters and data loggers into captive and free-ranging animals has increased greatly in the past two decades. The devices have become smaller, more reliable, and more capable (Printz 2004; Wilson and Gifford 2005; Metcalfe et al. 2012). Compared with externally mounted devices, implanted devices are largely invisible to external viewers such as tourists and predators; exist in a physically protected, thermally stable environment in mammals and birds; and greatly reduce drag and risk of entanglement. An implanted animal does not outgrow its device or attachment method as can happen with collars and harnesses, which allows young animals to be more safely equipped. However, compared with mounting external devices, implantation requires greater technical ability to perform the necessary anesthesia, analgesia, and surgery. More than 83% of publications in the 1990s that used radiotelemetry on animals assumed that there were no adverse effects on the animal (Godfrey and Bryant 2003). It is likely that some studies using implanted electronic devices have not been published due to a high level of unexpected mortality or to aberrant behavior or disappearance of the implanted animals, a phenomenon known as the “file drawer” problem (Rosenthal 1979; Scargle 2000). The near absence of such studies from the published record may be providing a false sense of security that procedures being used are more innocuous than they actually are. Similarly, authors sometimes state that it was unlikely that device implantation was problematic because study animals appeared to behave normally, or authors state that previous investigators used the same technique and saw no problems. Such statements are suppositions if no supporting data are provided or if the animals were equipped because there was no other way to follow their activity. Moreover, such suppositions ignore other adverse effects that affect behavior indirectly, and

Fluoroscopy-Guided Resolution of Ingested Thrombus Leading to Functional Disturbance of a Continuous-Flow Left Ventricular Assist Device

Directory of Open Access Journals (Sweden)

Jens Garbade

2012-01-01

Full Text Available The third generation of left ventricular assist devices (LVADs has been shown to improve outcome and quality of life in patients suffering from acute and chronic heart failure. However, VAD-associated complications are still a challenge in the clinical practice. Here we report the resolution of a mobile thrombus formation in the proximity of the inflow cannula of a third generation of LVADs (HVAD Pump, HeartWare, Inc. in a patient with chronic heart failure 4 months after implantation.

Translation and validation of the assistive technology device predisposition assessment in Greek in order to assess satisfaction with use of the selected assistive device.

Science.gov (United States)

Koumpouros, Yiannis; Papageorgiou, Effie; Karavasili, Alexandra; Alexopoulou, Despoina

2017-07-01

To examine the Assistive Technology Device Predisposition Assessment scale and provide evidence of validity and reliability of the Greek version. We translated and adapted the original instrument in Greek according to the most well-known guidelines recommendations. Field test studies were conducted in a rehabilitation hospital to validate the appropriateness of the final results. Ratings of the different items were statistically analyzed. We recruited 115 subjects who were administered the Form E of the original questionnaire. The experimental analysis conducted revealed a three subscales structure: (i) Adaptability, (ii) Fit to Use, and (iii) Socializing. According to the results of our study the three subscales measure different constructs. Reliability measures (ICC = 0.981, Pearson's correlation = 0.963, Cronbach's α = 0.701) yielded high values. Test-retest outcome showed great stability. This is the first study, at least to the knowledge of the authors, which focuses merely on measuring the satisfaction of the users from the used assistive device, while exploring the Assistive Technology Device Predisposition Assessment - Device Form in such depth. According to the results, it is a stable, valid and reliable instrument and applicable to the Greek population. Thus, it can be used to measure the satisfaction of patients with assistive devices. Implications for Rehabilitation The paper explores the cultural adaptability and applicability of ATD PA - Device Form. ATD PA - Device Form can be used to assess user satisfaction by the selected assistive device. ATD PA - Device Form is a valid and reliable instrument in measuring users' satisfaction in Greekreality.

Safety, efficacy, and performance of implanted recycled cardiac rhythm management (CRM) devices in underprivileged patients.

Science.gov (United States)

Hasan, Reema; Ghanbari, Hamid; Feldman, Dustin; Menesses, Daniel; Rivas, Daniel; Zakhem, Nicole C; Duarte, Carlos; Machado, Christian

2011-06-01

Patients in underdeveloped nations have limited access to life-saving medical technology including cardiac rhythm management (CRM) devices. We evaluated alternative means to provide such technology to this patient population while assessing the safety and efficacy of such a practice. Patients in the United States with clinical indications for extraction of CRM devices were consented. Antemortem CRM devices were cleaned and sterilized following a protocol established at our institution. Surveillance in vitro cultures were performed for quality assurance. The functional status of pulse generators was tested with a pacing system analyzer to confirm at least 70% battery life. Most generators were transported, in person, to an implanting institution in Nicaragua. Recipients with a Class I indication for CRM implantation, and meeting economical criteria set forth, were consented for implantation of a recycled device. Between 2003 and 2009, implantation was performed in 17 patients with an average age of 42.1 ± 20.3 years. Of the 17 patients, nine were male and eight were female. Mean follow-up was 68 ± 38 months. Device evaluation occurred prior to discharge, 4 weeks post implantation, and every 6 months thereafter. There were three deaths during the follow-up period secondary to myocardial infarction, stroke, and heart failure. Hematoma formation occurred in one patient. No infections, early battery depletion, or device malfunction were identified during follow-up. Our case series is the longest follow-up of recipients of recycled antemortem CRM devices. Our findings support the feasibility and safety of this alternative acquisition of life-saving technology. ©2011, The Authors. Journal compilation ©2011 Wiley Periodicals, Inc.

Utilization of YouTube as a Tool to Assess Patient Perception Regarding Implanted Cardiac Devices.

Science.gov (United States)

Hayes, Kevin; Mainali, Prajeena; Deshmukh, Abhishek; Pant, Sadip; Badheka, Apurva O; Paydak, Hakan

2014-07-01

The outreach of YouTube may have a dramatic role in the widespread dissemination of knowledge on implantable cardioverter devices (ICD). This study was designed to review and analyze the information available on YouTube pertaining to implantable cardiac devices such as implantable cardioverter defibrillators (ICDs) and pacemakers. YouTube was queried for the terms "ICD", "Implantable Cardioverter Defibrillator", and "Pacemaker". The videos were reviewed and categorized as according to content; number of views and "likes" or "dislikes" was recorded by two separate observers. Of the 55 videos reviewed, 18 of the videos were categorized as patient education, 12 were advertisements, 8 were intraoperative videos documenting the device implantation procedures, 7 of the videos were produced to document personal patient experiences, and 4 were categorized as documentation of a public event. 3 were intended to educate health care workers. The remaining 3 were intended to raise public awareness about sudden cardiac death. The videos portraying intraoperative procedures generated the most "likes" or "dislikes" per view. While YouTube provides a logical platform for delivery of health information, the information on this platform is not regulated. Initiative by reputed authorities and posting accurate information in such platform can be a great aid in public education regarding device therapy.

Non-Exposure, Device-Assisted Endoscopic Full-thickness Resection.

Science.gov (United States)

Bauder, Markus; Schmidt, Arthur; Caca, Karel

2016-04-01

Recent developments have expanded the frontier of interventional endoscopy toward more extended resections following surgical principles. This article presents two new device-assisted techniques for endoscopic full-thickness resection in the upper and lower gastrointestinal tract. Both methods are nonexposure techniques avoiding exposure of gastrointestinal contents to the peritoneal cavity by a "close first-cut later" principle. The full-thickness resection device is a novel over-the-scope device designed for clip-assisted full-thickness resection of colorectal lesions. Endoscopic full-thickness resection of gastric subepithelial tumors can be performed after placing transmural sutures underneath the tumor with a suturing device originally designed for endoscopic antireflux therapy. Copyright © 2016 Elsevier Inc. All rights reserved.

The Ventricular Assist Device in the Life of the Child: A Phenomenological Pediatric Study

Science.gov (United States)

van Manen, Michael A.

2017-01-01

What is it like for a child to live with an artificial heart? The use of some medical therapies in children requires developmental considerations, is associated with psychosocial consequences, and calls for ethical sensitivities. A critical case is the ventricular assist device (VAD), a mechanical pump used to support the functioning of a failing heart. As a pediatric therapy, the device can be used as a temporary solution for poor heart function, a bridge to transplantation or recovery, or as a destination therapy. While the mechanical-technical operation of the VAD is well understood, the clinical-technical aspects of young people living with this device are largely unexplored. Drawing on interviews of school-aged children, the aim of this phenomenological study is to explore how a VAD may structure or condition a child’s meaningful experience of their world outside the hospital. The driveline of an implanted VAD is the peripheral attachment, extruding through the skin to connect the controller-power supply. The materiality of the device may be interruptive, restrictive, and disturbing to the psycho-physical being and sense of self-identity of the child as a child. And while a child equipped with a VAD is not necessarily conspicuous among other children, the child may experience the device as an exposing presence, while living with the worry of a caregiver who takes on the role not simply of parent but of watchful health professional. A phenomenological understanding of the VAD should assist parents and caregiving health professionals knowing how to deal with specific issues arising in the life of the VAD child. PMID:28682718

Carotid Doppler ultrasound findings in patients with left ventricular assist devices.

Science.gov (United States)

Cervini, Patrick; Park, Soon J; Shah, Dipesh K; Penev, Irina E; Lewis, Bradley D

2010-12-01

Left ventricular assist devices (LVADs) have been used to treat advanced heart failure refractory to medical management, as bridge therapy to myocardial recovery, as bridge therapy to cardiac transplantation, or as destination therapy for patients with unfavorable transplant candidacy. Neurologic complications are some of the most common and devastating complications in these patients. Preoperative carotid ultrasound is, therefore, a standard evaluation in patients at risk for cerebrovascular disease. Postoperative carotid artery Doppler sonography is performed in those patients with neurologic symptoms. It is likely, therefore, that sonographers, radiologists, and other physicians working in a center where LVADs are implanted will likely encounter a carotid artery Doppler study in this patient group. To our knowledge, the carotid Doppler findings in these patients have never been published. We review the Doppler ultrasound findings in 6 patients after LVAD insertion.

Personalized Remote Monitoring of the Atrial Fibrillation Patients with Electronic Implant Devices

Directory of Open Access Journals (Sweden)

Gokce B. Laleci

2011-01-01

Full Text Available Cardiovascular Implantable Electronic Devices (CIED are gaining popularity in treating patients with heart disease. Remote monitoring through care management systems enables continuous surveillance of such patients by checking device functions and clinical events. These care management systems include decision support capabilities based on clinical guidelines. Data input to such systems are from different information sources including medical devices and Electronic Health Records (EHRs. Although evidence-based clinical guidelines provides numerous benefits such as standardized care, reduced costs, efficient and effective care management, they are currently underutilized in clinical practice due to interoperability problems among different healthcare data sources. In this paper, we introduce the iCARDEA care management system for atrial fibrillation patients with implant devices and describe how the iCARDEA care plan engine executes the clinical guidelines by seamlessly accessing the EHR systems and the CIED data through standard interfaces.

Stroke Risk and Mortality in Patients With Ventricular Assist Devices.

Science.gov (United States)

Parikh, Neal S; Cool, Joséphine; Karas, Maria G; Boehme, Amelia K; Kamel, Hooman

2016-11-01

Ventricular assist devices (VADs) have advanced the management of end-stage heart failure. However, these devices are associated with hemorrhagic and thrombotic complications, including stroke. We assessed the incidence, risk factors, and outcomes of ischemic and hemorrhagic stroke after VAD placement. Using administrative claims data from acute care hospitals in California, Florida, and New York from 2005 to 2013, we identified patients who underwent VAD placement, defined by the International Classification of Diseases, Ninth Revision, Clinical Modification code 37.66. Ischemic and hemorrhagic strokes were identified by previously validated coding algorithms. We used survival statistics to determine the incidence rates and Cox proportional hazard analyses to examine the associations. Among 1813 patients, we identified 201 ischemic strokes and 116 hemorrhagic strokes during 3.4 (±2.0) years of follow-up after implantation of a VAD. The incidence of stroke was 8.7% per year (95% confidence interval [CI], 7.7-9.7). The annual incidence of ischemic stroke (5.5%; 95% CI, 4.8-6.4) was nearly double that of hemorrhagic stroke (3.1%; 95% CI, 2.6-3.8). Women faced a higher hazard of stroke than men (hazard ratio, 1.6; 95% CI, 1.2-2.1), particularly hemorrhagic stroke (hazard ratio, 2.2; 95% CI, 1.4-3.4). Stroke was strongly associated with subsequent in-hospital mortality (hazard ratio, 6.1; 95% CI, 4.6-7.9). The incidence of stroke after VAD implantation was 8.7% per year, and incident stroke was strongly associated with subsequent in-hospital mortality. Notably, ischemic stroke occurred at nearly twice the rate of hemorrhagic stroke. Women seemed to face a higher risk for hemorrhagic stroke than men. © 2016 American Heart Association, Inc.

Implant-assisted removable partial dentures as an alternative treatment for partial edentulism: a review of the literature.

Science.gov (United States)

Chatzivasileiou, Konstantinos; Kotsiomiti, Eleni; Emmanouil, Ioannis

2015-01-01

This study reviewed the current literature concerning implant-assisted removable partial dentures (RPDs) in order to present the existing knowledge about performance issues. An electronic search was conducted on the PubMed database for published English-language articles that contained information about implant-assisted RPDs. A review of these articles indicated that the combination of dental implants with RPDs constitutes a cost-efficient prosthetic protocol that can offer solutions to problematic aspects of treatment with removable partial dentures. Well-designed studies are still needed to provide robust evidence on critical issues, such as design guidelines, long-term survival of implants associated with RPDs, and their effect on patients' quality of life.

Stab injury and device implantation within the brain results in inversely multiphasic neuroinflammatory and neurodegenerative responses

Science.gov (United States)

Potter, Kelsey A.; Buck, Amy C.; Self, Wade K.; Capadona, Jeffrey R.

2012-08-01

An estimated 25 million people in the US alone rely on implanted medical devices, ˜2.5 million implanted within the nervous system. Even though many devices perform adequately for years, the host response to medical devices often severely limits tissue integration and long-term performance. This host response is believed to be particularly limiting in the case of intracortical microelectrodes, where it has been shown that glial cell encapsulation and localized neuronal cell loss accompany intracortical microelectrode implantation. Since neuronal ensembles must be within ˜50 µm of the electrode to obtain neuronal spikes and local field potentials, developing a better understanding of the molecular and cellular environment at the device-tissue interface has been the subject of significant research. Unfortunately, immunohistochemical studies of scar maturation in correlation to device function have been inconclusive. Therefore, here we present a detailed quantitative study of the cellular events and the stability of the blood-brain barrier (BBB) following intracortical microelectrode implantation and cortical stab injury in a chronic survival model. We found two distinctly inverse multiphasic profiles for neuronal survival in device-implanted tissue compared to stab-injured animals. For chronically implanted animals, we observed a biphasic paradigm between blood-derived/trauma-induced and CNS-derived inflammatory markers driving neurodegeneration at the interface. In contrast, stab injured animals demonstrated a CNS-mediated neurodegenerative environment. Collectively these data provide valuable insight to the possibility of multiple roles of chronic neuroinflammatory events on BBB disruption and localized neurodegeneration, while also suggesting the importance to consider multiphasic neuroinflammatory kinetics in the design of therapeutic strategies for stabilizing neural interfaces.

Outcomes of pediatric patients supported with continuous-flow ventricular assist devices: A report from the Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS).

Science.gov (United States)

Rossano, Joseph W; Lorts, Angela; VanderPluym, Christina J; Jeewa, Aamir; Guleserian, Kristine J; Bleiweis, Mark S; Reinhartz, Olaf; Blume, Elizabeth D; Rosenthal, David N; Naftel, David C; Cantor, Ryan S; Kirklin, James K

2016-05-01

Continuous-flow (CF) ventricular assist devices (VADs) have largely replaced pulsatile-flow VADs in adult patients. However, there are few data on CF VADs among pediatric patients. In this study we aimed to describe the overall use, patients' characteristics and outcomes of CF VADs in this population. The Pediatric Interagency Registry for Mechanical Circulatory Support (PediMACS) is a national registry for U.S. Food and Drug Adminstration (FDA)-approved VADs in patients <19 years of age. Patients undergoing placement of durable CF VADs between September 2012 and June 2015 were included and outcomes were compared with those of adults from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). CF VADs were implanted in 109 patients at 35 hospitals. The median age at implantation was 15 years (2.8 to 18.9 years) and median weight was 62 kg (range 16 to 141 kg). The underlying disease was cardiomyopathy in 89 (82%) patients. The INTERMACS level at time of implant was Level 1 in 20 (19%), Level 2 in 64 (61%) and Levels 3 to 7 in 21 (20%) patients. Most were implanted as LVADs (n = 102, 94%). Median duration of support was 2.3 months (range <1 day to 28 months). Serious adverse event rates were low, including neurologic dysfunction (early event rate 4.1 per 100 patient-months with 2 late events). Competing outcomes analysis at 6 months post-implant indicated 61% transplanted, 31% alive with device in place and 8% death before transplant. These outcomes compared favorably with the 3,894 adults supported with CF VADs as a bridge to transplant. CF VADs are commonly utilized in older children and adolescents, with excellent survival rates. Further study is needed to understand impact of patient and device characteristics on outcomes in pediatric patients. Copyright © 2016 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Complications with computer-aided designed/computer-assisted manufactured titanium and soldered gold bars for mandibular implant-overdentures: short-term observations.

Science.gov (United States)

Katsoulis, Joannis; Wälchli, Julia; Kobel, Simone; Gholami, Hadi; Mericske-Stern, Regina

2015-01-01

Implant-overdentures supported by rigid bars provide stability in the edentulous atrophic mandible. However, fractures of solder joints and matrices, and loosening of screws and matrices were observed with soldered gold bars (G-bars). Computer-aided designed/computer-assisted manufactured (CAD/CAM) titanium bars (Ti-bars) may reduce technical complications due to enhanced material quality. To compare prosthetic-technical maintenance service of mandibular implant-overdentures supported by CAD/CAM Ti-bar and soldered G-bar. Edentulous patients were consecutively admitted for implant-prosthodontic treatment with a maxillary complete denture and a mandibular implant-overdenture connected to a rigid G-bar or Ti-bar. Maintenance service and problems with the implant-retention device complex and the prosthesis were recorded during minimally 3-4 years. Annual peri-implant crestal bone level changes (ΔBIC) were radiographically assessed. Data of 213 edentulous patients (mean age 68 ± 10 years), who had received a total of 477 tapered implants, were available. Ti-bar and G-bar comprised 101 and 112 patients with 231 and 246 implants, respectively. Ti-bar mostly exhibited distal bar extensions (96%) compared to 34% of G-bar (p overdentures supported by soldered gold bars or milled CAD/CAM Ti-bars are a successful treatment modality but require regular maintenance service. These short-term observations support the hypothesis that CAD/CAM Ti-bars reduce technical complications. Fracture location indicated that the titanium thickness around the screw-access hole should be increased. © 2013 Wiley Periodicals, Inc.

Implantable optogenetic device with CMOS IC technology for simultaneous optical measurement and stimulation

Science.gov (United States)

Haruta, Makito; Kamiyama, Naoya; Nakajima, Shun; Motoyama, Mayumi; Kawahara, Mamiko; Ohta, Yasumi; Yamasaki, Atsushi; Takehara, Hiroaki; Noda, Toshihiko; Sasagawa, Kiyotaka; Ishikawa, Yasuyuki; Tokuda, Takashi; Hashimoto, Hitoshi; Ohta, Jun

2017-05-01

In this study, we have developed an implantable optogenetic device that can measure and stimulate neurons by an optical method based on CMOS IC technology. The device consist of a blue LED array for optically patterned stimulation, a CMOS image sensor for acquiring brain surface image, and eight green LEDs surrounding the CMOS image sensor for illumination. The blue LED array is placed on the CMOS image sensor. We implanted the device in the brain of a genetically modified mouse and successfully demonstrated the stimulation of neurons optically and simultaneously acquire intrinsic optical images of the brain surface using the image sensor. The integrated device can be used for simultaneously measuring and controlling neuronal activities in a living animal, which is important for the artificial control of brain functions.

An unusual etiological agent of implantable cardioverter device endocarditis: Corynebacterium mucifaciens

Directory of Open Access Journals (Sweden)

Adnan Kaya

2016-03-01

Full Text Available Cardiac pacing devices and implantable cardioverter defibrillator (ICD are becoming the mainstay of therapy in cardiology and infective endocarditis (IE and pocket infection; however, these devices require careful monitoring. Here, we describe a case of a 68-year-old female with an ICD presenting with a previously unknown etiological agent of IE, Corynebacterium mucifaciens.

Miniscrew implant applications in contemporary orthodontics

Directory of Open Access Journals (Sweden)

Hong-Po Chang

2014-03-01

Full Text Available The need for orthodontic treatment modalities that provide maximal anchorage control but with minimal patient compliance requirements has led to the development of implant-assisted orthodontics and dentofacial orthopedics. Skeletal anchorage with miniscrew implants has no patient compliance requirements and has been widely incorporated in orthodontic practice. Miniscrew implants are now routinely used as anchorage devices in orthodontic treatment. This review summarizes recent data regarding the interpretation of bone data (i.e., bone quantity and quality obtained by preoperative diagnostic computed tomography (CT or by cone-beam computed tomography (CBCT prior to miniscrew implant placement. Such data are essential when selecting appropriate sites for miniscrew implant placement. Bone characteristics that are indications and contraindications for treatment with miniscrew implants are discussed. Additionally, bicortical orthodontic skeletal anchorage, risks associated with miniscrew implant failure, and miniscrew implants for nonsurgical correction of occlusal cant or vertical excess are reviewed. Finally, implant stability is compared between titanium alloy and stainless steel miniscrew implants.

Patient perspective on remote monitoring of cardiovascular implantable electronic devices

DEFF Research Database (Denmark)

Versteeg, H; Pedersen, Susanne S.; Mastenbroek, M H

2014-01-01

-implantation, other check-ups are performed remotely. Patients are asked to complete questionnaires at five time points during the 2-year follow-up. CONCLUSION: The REMOTE-CIED study will provide insight into the patient perspective on remote monitoring in ICD patients, which could help to support patient......BACKGROUND: Remote patient monitoring is a safe and effective alternative for the in-clinic follow-up of patients with cardiovascular implantable electronic devices (CIEDs). However, evidence on the patient perspective on remote monitoring is scarce and inconsistent. OBJECTIVES: The primary...

Maxillary arch rehabilitation using implant-supported computer-assisted design-computer-assisted manufacturing-milled titanium framework

Directory of Open Access Journals (Sweden)

Tulika S Khanna

2017-01-01

Full Text Available Esthetic and functional rehabilitation of completely edentulous maxillary arch with fixed implant supported prosthesis is a challenging task. Newer technologies such as computer assisted design computer assisted manufacturing (CAD CAM and cone beam conventional tomography play an important role in achieving predictable results. Full mouth porcelain fused to metal (PFM individual crowns on CAD CAM milled titanium framework provides positive esthetic and functional outcome. This is a case report of rehabilitation of partially edentulous maxillary arch patient. Staged rehabilitation of this patient was planned. In the first stage, root canal treatment of key abutment teeth was done, nonsalvageable teeth were removed, and immediate interim overdenture was provided. In the second stage, five Nobel Biocare dental implants were placed. After integration impressions were made, CAD CAM milled titanium bar was fabricated. Individual PFM crowns were made and cemented. This method gives better esthetic compared to acrylic fused to metal hybrid prosthesis with the advantage of retrievability just like screw retained prosthesis. Hence, this technique is good for rehabilitation of patients with high esthetic demands.

Ion implantation on nickel targets by means of repetitive plasma focus device

Energy Technology Data Exchange (ETDEWEB)

Vitulli, S.; Rapezzi, L. [ENEA Brasimone, Camugnano, Bologna (Italy); Apicella, M.L.; Samuelli, M. [ENEA Frascati, Frascati, Roma (Italy)

2004-07-01

Some test has been done in order to assess the possible use of a plasma focus as an implanter. The device utilized is the repetitive Plasma Focus operating in the ENEA Brasimone Center. The implanted sample is a sheet of Nickel with a surface of 17 cm{sup 2} inserted in a rigid sample at a variable distance from the top of the anode. After irradiation the sample is analyzed with Auger spectroscopy that provides the surface concentration of the various elements on the sample at different implantation depths. The result of the analysis shows that the Plasma Focus is an effective implantation source, even for metallurgical applications. (orig.)

New implantable therapeutic device for the control of an atrial fibrillation attack using the Peltier element.

Science.gov (United States)

Yambe, Tomoyuki; Sumiyoshi, Taketada; Koga, Chihiro; Shiraishi, Yasuyuki; Miura, Hidekazu; Sugita, Norihiro; Tanaka, Akira; Yoshizawa, Makoto

2012-01-01

For the development of the new therapeutic device for the atrial fibrillation, implantable cooling device using Peltier element was developed in this study. An implantable cooling device had been consisted from Peltier element with transcutaneous energy transmission system (TETS). 1st coil can be contacted from outside of the body, when the patients will feel palpitation. Electrical current will be induced to the implanted 2nd coil. Peltier element will able to cool the surface of the atrium. For the confirmation of the effect of the cooling device, trial manufacture model was developed. Animal experiments using six healthy adult goats after animal ethical committee allowance was carried out. Fourth intercostals space had been opened after anesthesia inhalation, and various sensors had been inserted. AF was induced by the electrical current with battery. As the results, AF had been recovered to the normal sinus rhythm after cooling in all six goats. So, this cooling system for the control of AF showed evident effect in these experiments. Smaller size cooling device has been under development aiming at totally implantable type. Catheter type cooling device for the insertion by the use of fiber-scope type is now under planning for the clinical application. This new type device may be able to become good news for the patients with uncontrollable AF.

Study on hydrogen assisted cracking susceptibility of HSLA steel by implant test

Directory of Open Access Journals (Sweden)

Gopa Chakraborty

2016-12-01

Full Text Available DMR-249A is an indigenously developed high strength low alloy steel for Indian ship building industry for making ship-hull and is extensively used in the construction of war ships and submarines. Welding electrodes conforming to SFA 5.5 AWS E8018 C1 has been indigenously developed for welding of this steel using shielded metal arc welding process. In the present study, susceptibility to hydrogen assisted cracking of DMR-249A steel welds made using this electrode has been assessed using implant test. Implant tests were conducted using this electrode at two different levels of diffusible hydrogen, measured using gas chromatography technique. It is observed that both the steel and the welding consumable are not susceptible to hydrogen assisted cracking even with a high diffusible hydrogen level of 9 mL/100g of weld metal. In implant tests, specimen did not fracture even after loading to stress levels higher than the yield strength of the base metal. The good resistance of this steel and the welding consumable, even with high levels of diffusible hydrogen, is attributed to absence of a susceptible microstructure in both the weld metal and heat affected zone. Hence, this study shows that, in the absence of a susceptible microstructure, hydrogen assisted cracking is unlikely to occur even if hydrogen level is high. It also confirms that in welding of DMR-249A with indigenously developed E8018 C1 electrode, hydrogen assisted cracking is not a concern and no preheating is required to avoid it during welding.

Implantable Cardioverter-Defibrillators in Patients With a Continuous-Flow Left Ventricular Assist Device: An Analysis of the INTERMACS Registry.

Science.gov (United States)

Clerkin, Kevin J; Topkara, Veli K; Demmer, Ryan T; Dizon, Jose M; Yuzefpolskaya, Melana; Fried, Justin A; Mai, Xingchen; Mancini, Donna M; Takeda, Koji; Takayama, Hiroo; Naka, Yoshifumi; Colombo, Paolo C; Garan, A Reshad

2017-12-01

This study sought to determine if the presence of implantable cardioverter-defibrillators (ICD) provided a mortality benefit during continuous-flow left ventricular assist device (LVAD) support. An ICD decreases mortality in selected patients with advanced heart failure and have been associated with reduced mortality in patients with pulsatile LVAD. However, it is unclear whether that benefit extends to patients with a contemporary continuous-flow LVAD. Propensity score matching was used to generate a cohort of patients with similar baseline characteristics. The primary outcome was freedom from death during LVAD support. Secondary endpoints included freedom from unexpected death, likelihood of transplantation and recovery, and adverse events. Among 16,384 eligible patients in the Interagency Registry for Mechanically Assisted Circulatory Support registry, 2,209 patients with an ICD and 2,209 patients without one had similar propensity scores and were included. The presence of an ICD was associated with an increased mortality risk (hazard ratio: 1.20; 95% confidence interval [CI]: 1.04 to 1.39; p = 0.013) and an increased risk of unexpected death during device support (HR: 1.33; 95% CI: 1.03 to 1.71; p = 0.03). Patients with an ICD were more likely to undergo transplantation (HR: 1.16; 95% CI: 0.99 to 1.35; p = 0.06) and less likely to have LVAD explant for recovery (HR: 0.53, 95% CI: 0.29 to 0.98; p = 0.04). Patients with an ICD had a higher rate of treated ventricular arrhythmias (rate ratio: 1.27; 95% CI: 1.10 to 1.48; p = 0.001) and rehospitalization (rate ratio: 1.08; 95% CI: 1.04 to 1.12; p < 0.0001), but rates of hemorrhagic stroke were similar (rate ratio: 1.01; 95% CI: 0.81 to 1.26; p = 0.98). Among patients with a continuous flow LVAD, the presence of an ICD was not associated with reduced mortality. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Transdermal power transfer for recharging implanted drug delivery devices via the refill port.

Science.gov (United States)

Evans, Allan T; Chiravuri, Srinivas; Gianchandani, Yogesh B

2010-04-01

This paper describes a system for transferring power across a transdermal needle into a smart refill port for recharging implantable drug delivery systems. The device uses a modified 26 gauge (0.46 mm outer diameter) Huber needle with multiple conductive elements designed to couple with mechanical springs in the septum of the refill port of a drug delivery device to form an electrical connection that can sustain the current required to recharge a battery during a reservoir refill session. The needle is fabricated from stainless steel coated with Parylene, and the refill port septum is made from micromachined stainless steel contact springs and polydimethylsiloxane. The device properties were characterized with dry and wet ambient conditions. The needle and port pair had an average contact resistance of less than 2 Omega when mated in either environment. Electrical isolation between the system, the liquid in the needle lumen, and surrounding material has been demonstrated. The device was used to recharge a NiMH battery with currents up to 500 mA with less than 15 degrees C of resistive heating. The system was punctured 100 times to provide preliminary information with regard to device longevity, and exhibited about 1 Omega variation in contact resistance. The results suggest that this needle and refill port system can be used in an implant to enable battery recharging. This allows for smaller batteries to be used and ultimately increases the volume efficiency of an implantable drug delivery device.

Intraoperative Hemodynamic and Echocardiographic Measurements Associated With Severe Right Ventricular Failure After Left Ventricular Assist Device Implantation.

Science.gov (United States)

Gudejko, Michael D; Gebhardt, Brian R; Zahedi, Farhad; Jain, Ankit; Breeze, Janis L; Lawrence, Matthew R; Shernan, Stanton K; Kapur, Navin K; Kiernan, Michael S; Couper, Greg; Cobey, Frederick C

2018-06-05

Severe right ventricular failure (RVF) after left ventricular assist device (LVAD) implantation increases morbidity and mortality. We investigated the association between intraoperative right heart hemodynamic data, echocardiographic parameters, and severe versus nonsevere RVF. A review of LVAD patients between March 2013 and March 2016 was performed. Severe RVF was defined by the need for a right ventricular mechanical support device, inotropic, and/or inhaled pulmonary vasodilator requirements for >14 days. From a chart review, the right ventricular failure risk score was calculated and right heart hemodynamic data were collected. Pulmonary artery pulsatility index (PAPi) [(pulmonary artery systolic pressure - pulmonary artery diastolic pressure)/central venous pressure (CVP)] was calculated for 2 periods: (1) 30 minutes before cardiopulmonary bypass (CPB) and (2) after chest closure. Echocardiographic data were recorded pre-CPB and post-CPB by a blinded reviewer. Univariate logistic regression models were used to examine the performance of hemodynamic and echocardiographic metrics. A total of 110 LVAD patients were identified. Twenty-five did not meet criteria for RVF. Of the remaining 85 patients, 28 (33%) met criteria for severe RVF. Hemodynamic factors associated with severe RVF included: higher CVP values after chest closure (18 ± 9 vs 13 ± 5 mm Hg; P = .0008) in addition to lower PAPi pre-CPB (1.2 ± 0.6 vs 1.7 ± 1.0; P = .04) and after chest closure (0.9 ± 0.5 vs 1.5 ± 0.8; P = .0008). Post-CPB echocardiographic findings associated with severe RVF included: larger right atrial diameter major axis (5.4 ± 0.9 vs 4.9 ± 1.0 cm; P = .03), larger right ventricle end-systolic area (22.6 ± 8.4 vs 18.5 ± 7.9 cm; P = .03), lower fractional area of change (20.2 ± 10.8 vs 25.9 ± 12.6; P = .04), and lower tricuspid annular plane systolic excursion (0.9 ± 0.2 vs 1.1 ± 0.3 cm; P = .008). Right ventricular failure risk score was not a significant predictor of

Monitoring device acceptance in implantable cardioverter defibrillator patients using the Florida Patient Acceptance Survey

DEFF Research Database (Denmark)

Versteeg, Henneke; Starrenburg, Annemieke; Denollet, Johan

2012-01-01

Patient device acceptance might be essential in identifying patients at risk for adverse patient-reported outcomes following implantation of an implantable cardioverter defibrillator (ICD). We examined the validity and reliability of the Florida Patient Acceptance Scale (FPAS) and identified corr...

Temperature rise during removal of fractured components out of the implant body: an in vitro study comparing two ultrasonic devices and five implant types.

Science.gov (United States)

Meisberger, Eric W; Bakker, Sjoerd J G; Cune, Marco S

2015-12-01

Ultrasonic instrumentation under magnification may facilitate mobilization of screw remnants but may induce heat trauma to surrounding bone. An increase of 5°C is considered detrimental to osseointegration. The objective of this investigation was to examine the rise in temperature of the outer implant body after 30 s of ultrasonic instrumentation to the inner part, in relation to implant type, type of ultrasonic equipment, and the use of coolants in vitro. Two ultrasonic devices (Satelec Suprasson T Max and Electro Medical Systems (EMS) miniMaster) were used on five different implant types that were provided with a thermo couple (Astra 3.5 mm, bone level Regular CrossFit (RC) 4.1 mm, bone level Narrow CrossFit (NC) 3.3 mm, Straumann tissue level regular body regular neck 3.3 mm, and Straumann tissue level wide body regular neck 4.8 mm), either with or without cooling during 30 s. Temperature rise at this point in time is the primary outcome measure. In addition, the mean maximum rise in temperature (all implants combined) was assessed and statistically compared among devices, implant systems, and cooling mode (independent t-tests, ANOVA, and post hoc analysis). The Satelec device without cooling induces the highest temperature change of up to 13°C, particularly in both bone level implants (p < 0.05) but appears safe for approximately 10 s of continuous instrumentation, after which a cooling down period is rational. Cooling is effective for both devices. However, when the Satelec device is used with coolant for a longer period of time, a rise in temperature must be anticipated after cessation of instrumentation, and post-operational cooling is advised. The in vitro setup used in this experiment implies that care should be taken when translating the observations to clinical recommendations, but it is carefully suggested that the EMS device causes limited rise in temperature, even without coolant.

Tissue-electronics interfaces: from implantable devices to engineered tissues

Science.gov (United States)

Feiner, Ron; Dvir, Tal

2018-01-01

Biomedical electronic devices are interfaced with the human body to extract precise medical data and to interfere with tissue function by providing electrical stimuli. In this Review, we outline physiologically and pathologically relevant tissue properties and processes that are important for designing implantable electronic devices. We summarize design principles for flexible and stretchable electronics that adapt to the mechanics of soft tissues, such as those including conducting polymers, liquid metal alloys, metallic buckling and meandering architectures. We further discuss technologies for inserting devices into the body in a minimally invasive manner and for eliminating them without further intervention. Finally, we introduce the concept of integrating electronic devices with biomaterials and cells, and we envision how such technologies may lead to the development of bionic organs for regenerative medicine.

Status and progress in ion implantation technology for semiconductor device manufacturing

International Nuclear Information System (INIS)

Takahashi, Noriyuki

1998-01-01

Rapid growth in implant applications in the fabrication of semiconductors has encouraged a dramatic increase in the range of energies, beam currents and ion species used. The challenges of a wider energy range, higher beam currents, continued reduction in contamination, improved angle integrity and larger substrates have motivated the development of many innovations. Advanced processes in submicron device production uses up to twenty implantation steps. Thus the outstanding growth of this industry has led to the evolution of a thriving business of hundreds of implantation equipment systems each year with very specific requirements. The present paper reviews the principal process requirements which resulted in the evolution of the equipment technology, and describes the recent trends in the ion implanter technology all three principal categories: high current, medium current and high energy. (author)

Costs and reimbursement gaps after implementation of third-generation left ventricular assist devices.

Science.gov (United States)

Mishra, Vinod; Geiran, Odd; Fiane, Arnt E; Sørensen, Gro; Andresen, Sølvi; Olsen, Ellen K; Khushi, Ishtiaq; Hagen, Terje P

2010-01-01

The purpose of this study was to compare and contrast total hospital costs and subsequent reimbursement of implementing a new program using a third-generation left ventricular assist device (LVAD) in Norway. Between July 2005 and March 2008, the total costs of treatment for 9 patients were examined. Costs were calculated for three periods-the pre-implantation LVAD phase, the LVAD implantation phase and the post-implantation LVAD phase-as well as for total hospital care. Patient-specific costs were obtained prospectively from patient records and included personnel resources, medication, blood products, blood chemistry and microbiology, imaging, and procedure costs including operating room costs. Overhead costs were registered retrospectively and allocated to the specific patient by pre-defined allocation keys. Finally, patient-specific costs and overhead costs were aggregated into total patient costs. The average total patient cost in 2007 U.S. dollars was $735,342 and the median was $613,087 (range $342,581 to $1,256,026). The mean length of stay was 77 days (range 40 to 127 days). For the LVAD implantation phase, the mean cost was $457,795 and median cost was $458,611 (range $246,239 to $677,680). The mean length of stay for the LVAD implantation phase was 55 days (range 25 to 125 days). The diagnosis-related group (DRG) reimbursement (2007) was $143,192. There is significant discrepancy between actual hospital costs and the current Norwegian DRG reimbursement for the LVAD procedure. This discrepancy can be partly explained by excessive costs related to the introduction of a new program with new technology. Costly innovations should be considered in price setting of reimbursement for novel technology. Copyright (c) 2010 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

CT pre-operative planning of a new semi-implantable bone conduction hearing device

Energy Technology Data Exchange (ETDEWEB)

Law, Eric K.C.; Bhatia, Kunwar S.S. [Prince of Wales Hospital, The Chinese University of Hong Kong, Department of Imaging and Interventional Radiology, Hong Kong, SAR (China); Tsang, Willis S.S.; Tong, Michael C.F. [Prince of Wales Hospital, The Chinese University of Hong Kong, Department of Otorhinolaryngology, Head and Neck Surgery, Hong Kong, SAR (China); Shi, Lin [The Chinese University of Hong Kong, Department of Medicine and Therapeutics, Hong Kong, SAR (China); The Chinese University of Hong Kong, Chow Yuk Ho Technology Center for Innovative Medicine, Hong Kong, SAR (China)

2016-06-15

Accommodating a novel semi-implantable bone conduction hearing device within the temporal bone presents challenges for surgical planning. This study describes the utility of CT in pre-operative assessment of such an implant. Retrospective review of pre-operative CT, clinical and surgical records of 16 adults considered for device implantation. Radiological suitability was assessed on CT using 3D simulation software. Antero-posterior (AP) dimensions of the mastoid bone and minimum skull thickness were measured. CT planning results were correlated with operative records. Eight and five candidates were suitable for device placement in the transmastoid and retrosigmoid positions, respectively, and three were radiologically unsuitable. The mean AP diameter of the mastoid cavity was 14.6 mm for the transmastoid group and 4.6 mm for the retrosigmoid group (p < 0.05). Contracted mastoid and/or prior surgery were predisposing factors for unsuitability. Four transmastoid and five retrosigmoid positions required sigmoid sinus/dural depression and/or use of lifts due to insufficient bone capacity. A high proportion of patients being considered have contracted or operated mastoids, which reduces the feasibility of the transmastoid approach. This finding combined with the complex temporal bone geometry illustrates the importance of careful CT evaluation using 3D software for precise device simulation. (orig.)

The Heartmate III: design and in vivo studies of a maglev centrifugal left ventricular assist device.

Science.gov (United States)

Loree, H M; Bourque, K; Gernes, D B; Richardson, J S; Poirier, V L; Barletta, N; Fleischli, A; Foiera, G; Gempp, T M; Schoeb, R; Litwak, K N; Akimoto, T; Kameneva, M; Watach, M J; Litwak, P

2001-05-01

A compact implantable centrifugal left ventricular assist device (LVAD) (HeartMate III) featuring a magnetically levitated impeller is under development. The goal of our ongoing work is to demonstrate feasibility, low hemolysis, and low thrombogenicity of the titanium pump in chronic bovine in vivo studies. The LVAD is based on so-called bearingless motor technology and combines pump rotor, drive, and magnetic bearing functions in a single unit. The impeller is rotated (theta z) and levitated with both active (X, Y) and passive (Z, theta x, theta y) suspension. Six prototype systems have been built featuring an implantable titanium pump (69 mm diameter, 30 mm height) with textured blood contacting surfaces and extracorporeal electronics. The pumps were implanted in 9 calves (< or = 100 kg at implant) that were anticoagulated with Coumadin (2.5 < or = INR < or = 4.0) throughout the studies. Six studies were electively terminated (at 27-61 days), 1 study was terminated after the development of severe pneumonia and lung atelectasis (at 27 days) another study was terminated after cardiac arrest (at 2 days) while a final study is ongoing (at approximately 100 days). Mean pump flows ranged from 2 to 7 L/min, except for brief periods of exercise at 6 to 9 L/min. Plasma free hemoglobin ranged from 4 to 10 mg/dl. All measured biochemical indicators of end organ function remained within normal range. The pumps have met performance requirements in all 9 implants with acceptable hemolysis and no mechanical failures.

Analysis of Contemporary Methods for Designing Rotary Type Ventricular Assist Devices

Directory of Open Access Journals (Sweden)

E. P. Banin

2015-01-01

Full Text Available The research object is inlet apparatus of ventricular assist device, namely inlet cannula and straightener.The purpose of the study is to reveal features of blood flow in inlet apparatus of ventricular assist device. The mathematical modeling is carried out by computational fluid dynamics analysis in a stationary setting.The first part of study concerns the analysis of existing approaches to the numerical and experimental studies in designing the ventricular assist devices of rotary type. It reveals the features of each approach for their further application in practice. The article presents an original design of developed hydraulic test bench to verify the results of mathematical modeling. Analysis of foreign authors’ studies showed that there is no enough attention paid to design of the adjacent pump assemblies of ventricular assist device. The second part of study considers direct mathematical modeling of input apparatus of ventricular assist device. The study examined straightener with three or four blades. Mathematical modeling has revealed the presence of potentially dangerous stagnation zones and essential asymmetry of the outlet flow from the input unit. The found features must be taken in consideration in designing the ventricular assist device pumps. In the future we plan to use obtained data to create a parametric model of the rotor and the diffuser considering the abovementioned features.

Human implantation: the last barrier in assisted reproduction technologies?

Science.gov (United States)

Edwards, Robert G

2006-12-01

Implantation processes are highly complex involving the actions of numerous hormones, immunoglobulins, cytokines and other factors in the endometrium. They are also essential matters for the success of assisted reproduction. The nature of early embryonic development is of equal significance. It involves ovarian follicle growth, ovulation, fertilization and preimplantation growth. These processes are affected by imbalanced chromosomal constitutions or slow developmental periods. Post-implantation death is also a significant factor in cases of placental insufficiency or recurrent abortion. Clearly, many of these matters can significantly affect birth rates. This review is concerned primarily with the oocyte, the early embryo and its chromosomal anomalies, and the nature of factors involved in implantation. These are clearly among the most important features in determining successful embryonic and fetal growth. Successive sections cover the endocrine stimulation of follicle growth in mice and humans, growth of human embryos in vitro, their apposition and attachment to the uterus, factors involved in embryo attachment to uterine epithelium and later stages of implantation, and understanding the gene control of polarities and other aspects of preimplantation embryo differentiation. New aspects of knowledge include the use of human oocyte maturation in vitro as an approach to simpler forms of IVF, and new concepts in developmental genetics.

Evaluation of Automated Flagger Assistance Devices

Science.gov (United States)

2018-02-01

Automated flagger assistance devices (AFADs) are designed to improve worker safety by replacing flaggers who are typically located near traffic approaching a work zone. In this study, a new AFAD developed by the Missouri Department of Transportation ...

Pectoral nerves (PECS) and intercostal nerve block for cardiac resynchronization therapy device implantation.

Science.gov (United States)

Fujiwara, Atsushi; Komasawa, Nobuyasu; Minami, Toshiaki

2014-01-01

A 71-year-old man was scheduled to undergo cardiac resynchronization therapy device (CRTD) implantation. He was combined with severe chronic heart failure due to ischemic heart disease. NYHA class was 3 to 4 and electrocardiogram showed non-sustained ventricular. Ejection fraction was about 20% revealed by transthoracic echocardiogram. He was also on several anticoagulation medications. We planned to implant the device under the greater pectoral muscle. As general anesthesia was considered risky, monitored anesthesia care utilizing peripheral nerve block and slight sedation was scheduled. Pectoral nerves (PECS) block and intercostal block was performed under ultrasonography with ropivacaine. For sedation during the procedure, continuous infusion of dexmedetomidine without a loading dose was performed. The procedure lasted about 3 hours, but the patient showed no pain or restlessness. Combination of PECS block and intercostal block may provide effective analgesia for CRTD implantation.

Low Power Design for Future Wearable and Implantable Devices

Directory of Open Access Journals (Sweden)

Katrine Lundager

2016-10-01

Full Text Available With the fast progress in miniaturization of sensors and advances in micromachinery systems, a gate has been opened to the researchers to develop extremely small wearable/implantable microsystems for different applications. However, these devices are reaching not to a physical limit but a power limit, which is a critical limit for further miniaturization to develop smaller and smarter wearable/implantable devices (WIDs, especially for multi-task continuous computing purposes. Developing smaller and smarter devices with more functionality requires larger batteries, which are currently the main power provider for such devices. However, batteries have a fixed energy density, limited lifetime and chemical side effect plus the fact that the total size of the WID is dominated by the battery size. These issues make the design very challenging or even impossible. A promising solution is to design batteryless WIDs scavenging energy from human or environment including but not limited to temperature variations through thermoelectric generator (TEG devices, body movement through Piezoelectric devices, solar energy through miniature solar cells, radio-frequency (RF harvesting through antenna etc. However, the energy provided by each of these harvesting mechanisms is very limited and thus cannot be used for complex tasks. Therefore, a more comprehensive solution is the use of different harvesting mechanisms on a single platform providing enough energy for more complex tasks without the need of batteries. In addition to this, complex tasks can be done by designing Integrated Circuits (ICs, as the main core and the most power consuming component of any WID, in an extremely low power mode by lowering the supply voltage utilizing low-voltage design techniques. Having the ICs operational at very low voltages, will enable designing battery-less WIDs for complex tasks, which will be discussed in details throughout this paper. In this paper, a path towards battery

Subcutaneous Photovoltaic Infrared Energy Harvesting for Bio-Implantable Devices.

Science.gov (United States)

Moon, Eunseong; Blaauw, David; Phillips, Jamie D

2017-05-01

Wireless biomedical implantable devices on the mm-scale enable a wide range of applications for human health, safety, and identification, though energy harvesting and power generation are still looming challenges that impede their widespread application. Energy scavenging approaches to power biomedical implants have included thermal [1-3], kinetic [4-6], radio-frequency [7-11] and radiative sources [12-14]. However, the achievement of efficient energy scavenging for biomedical implants at the mm-scale has been elusive. Here we show that photovoltaic cells at the mm-scale can achieve a power conversion efficiency of more than 17 % for silicon and 31 % for GaAs under 1.06 μW/mm 2 infrared irradiation at 850 nm. Finally, these photovoltaic cells demonstrate highly efficient energy harvesting through biological tissue from ambient sunlight, or irradiation from infrared sources such as used in present-day surveillance systems, by utilizing the near infrared (NIR) transparency window between the 650 nm and 950 nm wavelength range [15-17].

Perioperative management for the prevention of bacterial infection in cardiac implantable electronic device placement

Directory of Open Access Journals (Sweden)

Katsuhiko Imai

2016-08-01

Full Text Available Cardiac implantable electronic devices (CIEDs have become important in the treatment of cardiac disease and placement rates increased significantly in the last decade. However, despite the use of appropriate antimicrobial prophylaxis, CIED infection rates are increasing disproportionately to the implantation rate. CIED infection often requires explantation of all hardware, and at times results in death. Surgical site infection (SSI is the most common cause of CIED infection as a pocket infection. The best method of combating CIED infection is prevention. Prevention of CIED infections comprises three phases: before, during, and after device implantation. The most critical factors in the prevention of SSIs are detailed operative techniques including the practice of proper technique by the surgeon and surgical team.

Training contraceptive providers to offer intrauterine devices and implants in contraceptive care: a cluster randomized trial.

Science.gov (United States)

Thompson, Kirsten M J; Rocca, Corinne H; Stern, Lisa; Morfesis, Johanna; Goodman, Suzan; Steinauer, Jody; Harper, Cynthia C

2018-06-01

US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60

Animal Models for Evaluation of Bone Implants and Devices: Comparative Bone Structure and Common Model Uses.

Science.gov (United States)

Wancket, L M

2015-09-01

Bone implants and devices are a rapidly growing field within biomedical research, and implants have the potential to significantly improve human and animal health. Animal models play a key role in initial product development and are important components of nonclinical data included in applications for regulatory approval. Pathologists are increasingly being asked to evaluate these models at the initial developmental and nonclinical biocompatibility testing stages, and it is important to understand the relative merits and deficiencies of various species when evaluating a new material or device. This article summarizes characteristics of the most commonly used species in studies of bone implant materials, including detailed information about the relevance of a particular model to human bone physiology and pathology. Species reviewed include mice, rats, rabbits, guinea pigs, dogs, sheep, goats, and nonhuman primates. Ultimately, a comprehensive understanding of the benefits and limitations of different model species will aid in rigorously evaluating a novel bone implant material or device. © The Author(s) 2015.

Biofunctionalization of surfaces by energetic ion implantation: Review of progress on applications in implantable biomedical devices and antibody microarrays

Science.gov (United States)

Bilek, Marcela M. M.

2014-08-01

Despite major research efforts in the field of biomaterials, rejection, severe immune responses, scar tissue and poor integration continue to seriously limit the performance of today's implantable biomedical devices. Implantable biomaterials that interact with their host via an interfacial layer of active biomolecules to direct a desired cellular response to the implant would represent a major and much sought after improvement. Another, perhaps equally revolutionary, development that is on the biomedical horizon is the introduction of cost-effective microarrays for fast, highly multiplexed screening for biomarkers on cell membranes and in a variety of analyte solutions. Both of these advances will rely on effective methods of functionalizing surfaces with bioactive molecules. After a brief introduction to other methods currently available, this review will describe recently developed approaches that use energetic ions extracted from plasma to facilitate simple, one-step covalent surface immobilization of bioactive molecules. A kinetic theory model of the immobilization process by reactions with long-lived, mobile, surface-embedded radicals will be presented. The roles of surface chemistry and microstructure of the ion treated layer will be discussed. Early progress on applications of this technology to create diagnostic microarrays and to engineer bioactive surfaces for implantable biomedical devices will be reviewed.

A Novel Transdermal Power Transfer Device for the Application of Implantable Microsystems

Directory of Open Access Journals (Sweden)

Jing-Quan Liu

2015-03-01

Full Text Available This paper presents a transdermal power transfer device for the application of implantable devices or systems. The device mainly consists of plug and socket. The power transfer process can be started after inserting the plug into the socket with an applied potential on the plug. In order to improve the maneuverability and reliability of device during power transfer process, the metal net with mesh structure were added as a part of the socket to serve as intermediate electrical connection layer. The socket was encapsulated by polydimethylsiloxane (PDMS with good biocompatibility and flexibility. Two stainless steel hollow needles placed in the same plane acted as the insertion part of the needle plug, and Parylene C thin films were deposited on needles to serve as insulation layers. At last, the properties of the transdermal power transfer device were tested. The average contact resistance between needle and metal mesh was 0.454 Ω after 50 random insertions, which showed good electrical connection. After NiMH (nickel-metal hydride batteries were recharged for 10 min with current up to 200 mA, the caused resistive heat was less than 0.6 °C, which also demonstrated the low charging temperature and was suitable for charging implantable devices.

Long-acting reversible contraceptives: intrauterine devices and the contraceptive implant.

Science.gov (United States)

Espey, Eve; Ogburn, Tony

2011-03-01

The provision of effective contraception is fundamental to the practice of women's health care. The most effective methods of reversible contraception are the so-called long-acting reversible contraceptives, intrauterine devices and implants. These methods have multiple advantages over other reversible methods. Most importantly, once in place, they do not require maintenance and their duration of action is long, ranging from 3 to 10 years. Despite the advantages of long-acting reversible contraceptive methods, they are infrequently used in the United States. Short-acting methods, specifically oral contraceptives and condoms, are by far the most commonly used reversible methods. A shift from the use of short-acting methods to long-acting reversible contraceptive methods could help reduce the high rate of unintended pregnancy in the United States. In this review of long-acting reversible contraceptive methods, we discuss the intrauterine devices and the contraceptive implant available in the United States, and we describe candidates for each method, noncontraceptive benefits, and management of complications.

Phrenic paralysis during cardiac electronic device implantation: incidence, causes and clinical course.

Science.gov (United States)

López-Gil, María; Fontenla, Adolfo; Juliá, Justo; Parra, Juan José; Arribas, Fernando

2016-10-01

Phrenic paralysis is a known complication of central venous catheterization, but it is not listed as a complication related to cardiac implantable electronic device (CIED) implants. The aim of this study is to describe the incidence, causes, clinical picture, and management of phrenic paralysis occurring in this scenario. We retrospectively analysed data from our CIED implantation database and identified those patients who suffered phrenic paralysis during the implantation procedure. Four of 891 patients (subclavian puncture in 626) developed phrenic paralysis during pacemaker or defibrillator implant procedures. Severe respiratory failure needing ventilatory support occurred in two, being the phrenic paralysis transient in all of the cases. Transient phrenic paralysis may occur during CIED implantation probably related to the infiltration of local anaesthesia in the subclavian area. Mechanism, prevention, and management are discussed. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2016. For permissions please email: journals.permissions@oup.com.

Hybrid Donor-Dot Devices made using Top-down Ion Implantation for Quantum Computing

Science.gov (United States)

Bielejec, Edward; Bishop, Nathan; Carroll, Malcolm

2012-02-01

We present progress towards fabricating hybrid donor -- quantum dots (QD) for quantum computing. These devices will exploit the long coherence time of the donor system and the surface state manipulation associated with a QD. Fabrication requires detection of single ions implanted with 10's of nanometer precision. We show in this talk, 100% detection efficiency for single ions using a single ion Geiger mode avalanche (SIGMA) detector integrated into a Si MOS QD process flow. The NanoImplanter (nI) a focused ion beam system is used for precision top-down placement of the implanted ion. This machine has a 10 nm resolution combined with a mass velocity filter, allowing for the use of multi-species liquid metal ion sources (LMIS) to implant P and Sb ions, and a fast blanking and chopping system for single ion implants. The combination of the nI and integration of the SIGMA with the MOS QD process flow establishes a path to fabricate hybrid single donor-dot devices. Sandia National Laboratories is a multi-program laboratory managed and operated by Sandia Corporation, a wholly owned subsidiary of Lockheed Martin Corporation, for the U.S. Department of Energy's National Nuclear Security Administration under contract DE-AC04-94AL85000.

Compensating for Tissue Changes in an Ultrasonic Power Link for Implanted Medical Devices.

Science.gov (United States)

Vihvelin, Hugo; Leadbetter, Jeff; Bance, Manohar; Brown, Jeremy A; Adamson, Robert B A

2016-04-01

Ultrasonic power transfer using piezoelectric devices is a promising wireless power transfer technology for biomedical implants. However, for sub-dermal implants where the separation between the transmitter and receiver is on the order of several acoustic wavelengths, the ultrasonic power transfer efficiency (PTE) is highly sensitive to the distance between the transmitter and receiver. This sensitivity can cause large swings in efficiency and presents a serious limitation on battery life and overall performance. A practical ultrasonic transcutaneous energy transfer (UTET) system design must accommodate different implant depths and unpredictable acoustic changes caused by tissue growth, hydration, ambient temperature, and movement. This paper describes a method used to compensate for acoustic separation distance by varying the transmit (Tx) frequency in a UTET system. In a benchtop UTET system we experimentally show that without compensation, power transfer efficiency can range from 9% to 25% as a 5 mm porcine tissue sample is manipulated to simulate in situ implant conditions. Using an active frequency compensation method, we show that the power transfer efficiency can be kept uniformly high, ranging from 20% to 27%. The frequency compensation strategy we propose is low-power, non-invasive, and uses only transmit-side measurements, making it suitable for active implanted medical device applications.

Implantable Glucose BioFuel Cells for Medical Devices

International Nuclear Information System (INIS)

Cinquin, P; Martin, D K; Cosnier, S; Belgacem, N; Cosnier, M L; Dal Molin, R

2013-01-01

An Implantable BioFuel Cell (IBFC) is a device that produces power only from the chemicals that are naturally occurring inside the body. We have been working on two approaches to creating an IBFC. The first approach is to use chemicals such as glucose and oxygen to provide the fuel for an enzymatic IBFC. The second approach is to use electrolytes such as sodium to provide the fuel for a biomimetic IBFC

An Implantable MEMS Drug Delivery Device for Rapid Delivery in Ambulatory Emergency Care

Science.gov (United States)

2009-06-01

controlled devices provide advantages over passive release devices, as the drug delivery process can be controlled actively after implantation and...mm, 5 μm, 100 Å, Alltech Associates, USA), with methanol and 0.1% trifluoroacetic acid (TFA) in water. The gradient used was 2 % TFA/min, starting

SdrF, a Staphylococcus epidermidis surface protein, contributes to the initiation of ventricular assist device driveline-related infections.

Directory of Open Access Journals (Sweden)

Carlos Arrecubieta

2009-05-01

Full Text Available Staphylococcus epidermidis remains the predominant pathogen in prosthetic-device infections. Ventricular assist devices, a recently developed form of therapy for end-stage congestive heart failure, have had considerable success. However, infections, most often caused by Staphylococcus epidermidis, have limited their long-term use. The transcutaneous driveline entry site acts as a potential portal of entry for bacteria, allowing development of either localized or systemic infections. A novel in vitro binding assay using explanted drivelines obtained from patients undergoing transplantation and a heterologous lactococcal system of surface protein expression were used to identify S. epidermidis surface components involved in the pathogenesis of driveline infections. Of the four components tested, SdrF, SdrG, PIA, and GehD, SdrF was identified as the primary ligand. SdrF adherence was mediated via its B domain attaching to host collagen deposited on the surface of the driveline. Antibodies directed against SdrF reduced adherence of S. epidermidis to the drivelines. SdrF was also found to adhere with high affinity to Dacron, the hydrophobic polymeric outer surface of drivelines. Solid phase binding assays showed that SdrF was also able to adhere to other hydrophobic artificial materials such as polystyrene. A murine model of infection was developed and used to test the role of SdrF during in vivo driveline infection. SdrF alone was able to mediate bacterial adherence to implanted drivelines. Anti-SdrF antibodies reduced S. epidermidis colonization of implanted drivelines. SdrF appears to play a key role in the initiation of ventricular assist device driveline infections caused by S. epidermidis. This pluripotential adherence capacity provides a potential pathway to infection with SdrF-positive commensal staphylococci first adhering to the external Dacron-coated driveline at the transcutaneous entry site, then spreading along the collagen

Real-world geographic variations in the use of cardiac implantable electronic devices - The PANORAMA 2 observational cohort study.

Science.gov (United States)

Bastian, Dirk; Ebrahim, Iftikhar O; Chen, Ju-Yi; Chen, Mien-Cheng; Huang, Dejia; Huang, Jin-Long; Kuznetsov, Vadim A; Maus, Bärbel; Naik, Ajay M; Verhees, Koen J P; Fagih, Ahmed R Al

2018-06-13

Currently, several geographies around the world remain underrepresented in medical device trials. The PANORAMA 2 study was designed to assess contemporary region-specific differences in clinical practice patterns of patients with cardiac implantable electronic devices (CIEDs). In this prospective, multicenter, observational, multi-national study, baseline and implant data of 4,706 patients receiving Medtronic CIEDs (either de novo device implants, replacements, or upgrades) were analyzed, consisting of: 54% implantable pulse generators (IPGs), 20.3% implantable cardiac defibrillators (ICDs), 15% cardiac resynchronization therapy defibrillators (CRT-Ds), 5.1% cardiac resynchronization therapy pacemakers (CRT-Ps), from 117 hospitals in 23 countries across 4 geographical regions between 2012 and 2016. For all device types, in all regions, there were less females than males enrolled, and women were less likely to have ischemic cardiomyopathy. Implant procedure duration differed significantly across the geographies for all device types. Subjects from emerging countries, women and older patients were less likely to receive a magnetic resonance imaging (MRI)-compatible device. Defibrillation testing differed significantly between the regions. European patients had the highest rates of atrial fibrillation (AF), and the lowest number of implanted single-chamber IPGs. Evaluation of stroke history suggested that the general embolic risk is more strongly associated with stroke than AF. We provide comprehensive descriptive data on patients receiving Medtronic CIEDs from several geographies, some of which are understudied in randomized controlled trials (RCTs). We found significant variations in patient characteristics. Several medical decisions appear to be affected by socioeconomic factors. Long-term follow-up data will help evaluate if these variations require adjustments to outcome expectations. This article is protected by copyright. All rights reserved. This article is

[A totally implantable venous access device. Implantation in general or local anaesthesia? A retrospective cost analysis].

Science.gov (United States)

Schuld, J; Richter, S; Moussavian, M R; Kollmar, O; Schilling, M K

2009-08-01

Implantation of venous access port systems can be performed in local or general anesthesia. In spite of the increasing rate of interventionally implanted systems, the surgical cut-down represents a safe alternative. Thus, the question arises whether--in context to the increasing health-economic pressure--open implantation in general anesthesia is still a feasible alternative to implantation in local anesthesia regarding OR efficiency and costs. In a retrospective analysis, 993 patients receiving a totally implantable venous access device between 2001 and 2007 were evaluated regarding OR utilization, turnover times, intraoperative data and costs. Implantations in local (LA) and general anesthesia (GA) were compared. GA was performed in 762 cases (76.6 %), LA was performed in 231 patients (23.3 %). Mean operation time was similar in both groups (LA 47.27 +/- 1.40 min vs. GA 45.41 +/- 0.75 min, p = 0.244). Patients receiving local anesthesia had a significantly shorter stay in the OR unit (LA 95.9 +/- 1.78 min vs. GA 105.92 +/- 0.92 min; p cut (LA 39.57 +/- 0.69 min vs. GA 50.46 +/- 0.52 min; p material costs were significantly lower in the LA group compared with the GA group (LA: 400.72 +/- 8.25 euro vs. GA: 482.86 +/- 6.23 euro; p systems in local anesthesia is superior in comparison to the implantation under general anesthesia regarding procedural times in the OR unit and costs. With the same operation duration, but less personnel and material expenditure, implantation in local anesthesia offers a potential economic advantage by permitting faster changing times. Implantation in GA only should be performed at a special request by the patient or in difficult venous conditions. Georg Thieme Verlag Stuttgart.New York.

A monitoring device for pressurised-air-driven diaphragm-based artificial heart assist devices

NARCIS (Netherlands)

Hoeben, F.P.; Hoeben, F.P.; de Mul, F.F.M.; Stokkink, J.S.D.; Stokkink, H.S.D.; Koelink, M.H.; Koelink, M.H.; Greve, Jan

1992-01-01

A non-invasive device has been developed to monitor the diaphragm position and the blood flow in artificial heart assist devices equipped with a pressurised-air-driven diaphragm. Light scattering from the diaphragm is used as a mechanism for measuring. Information about the position of several

Intracorporeal Heat Distribution from Fully Implantable Energy Sources for Mechanical Circulatory Support: A Computational Proof-of-Concept Study

OpenAIRE

Biasetti, Jacopo; Pustavoitau, Aliaksei; Spazzini, Pier Giorgio

2017-01-01

Mechanical circulatory support devices, such as total artificial hearts and left ventricular assist devices, rely on external energy sources for their continuous operation. Clinically approved power supplies rely on percutaneous cables connecting an external energy source to the implanted device with the associated risk of infections. One alternative, investigated in the 70s and 80s, employs a fully implanted nuclear power source. The heat generated by the nuclear decay can be converted into ...

A 3D Printed Implantable Device for Voiding the Bladder Using Shape Memory Alloy (SMA) Actuators.

Science.gov (United States)

Hassani, Faezeh Arab; Peh, Wendy Yen Xian; Gammad, Gil Gerald Lasam; Mogan, Roshini Priya; Ng, Tze Kiat; Kuo, Tricia Li Chuen; Ng, Lay Guat; Luu, Percy; Yen, Shih-Cheng; Lee, Chengkuo

2017-11-01

Underactive bladder or detrusor underactivity (DU) is defined as a reduction of contraction strength or duration of the bladder wall. Despite the serious healthcare implications of DU, there are limited solutions for affected individuals. A flexible 3D printed implantable device driven by shape memory alloys (SMA) actuators is presented here for the first time to physically contract the bladder to restore voluntary control of the bladder for individuals suffering from DU. This approach is used initially in benchtop experiments with a rubber balloon acting as a model for the rat bladder to verify its potential for voiding, and that the operating temperatures are safe for the eventual implantation of the device in a rat. The device is then implanted and tested on an anesthetized rat, and a voiding volume of more than 8% is successfully achieved for the SMA-based device without any surgical intervention or drug injection to relax the external sphincter.

First pediatric transatlantic air ambulance transportation on a Berlin Heart EXCOR left ventricular assist device as a bridge to transplantation.

Science.gov (United States)

Tissot, Cecile; Buchholz, Holger; Mitchell, Max B; da Cruz, Eduardo; Miyamoto, Shelley D; Pietra, Bill A; Charpentier, Arnaud; Ghez, Olivier

2010-03-01

Mechanical circulatory devices are indicated in patients with refractory cardiac failure as a bridge to recovery or to transplantation. Whenever required, transportation while on mechanical support is a challenge and still limited by technical restrictions or distance. We report the first pediatric case of transatlantic air transportation on a Berlin Heart EXCOR ventricular assist device (Berlin Heart, Berlin, Germany) of a 13-yr-old American female who presented in cardiogenic shock with severe systolic dysfunction while vacationing in France. Rapid hemodynamic deterioration occurred despite maximal medical treatment, and she was supported initially with extracorporeal membrane oxygenation converted to a Berlin Heart EXCOR left ventricular assist device. Long-distance air transportation of the patient was accomplished 3 wks after implantation from Marseille, France, to Denver, Colorado. No adverse hemodynamic effects were encountered during the 13.5-hr flight (8770 km). The patient did not recover sufficient cardiac function and underwent successful orthotopic heart transplantation 3 months after the initial event. Our experience suggests that long-distance air transportation of pediatric patients using the Berlin Heart EXCOR mobile unit as a bridge to recovery or transplantation is feasible and appears safe.

Personal digital assistant-based, internet-enabled remote communication system for a wearable pneumatic biventricular assist device.

Science.gov (United States)

Nam, Kyoung Won; Lee, Jung Joo; Hwang, Chang Mo; Choi, Seong Wook; Son, Ho Sung; Sun, Kyung

2007-11-01

Currently, personal mobile communication devices have become quite common, and the applications of such devices have expanded quickly. Remote communication systems might be employed for the telemonitoring of patients or the operating status of their medical devices. In this article, we describe the development of a mobile-based artificial heart telemanagement system for use in a wearable extracorporeal pneumatic biventricular assist device, which is capable of telemonitoring and telecontrolling the operating status of the ventricular assist device from any site. The system developed herein utilized small mobile phones for the client device and adopted a standard transmission control protocol/Internet protocol communication protocol for the purposes of telecommunication. The results of in vitro and animal experiments showed that the telemanagement system developed herein operated in accordance with the desired parameters.

Single ion implantation for single donor devices using Geiger mode detectors

International Nuclear Information System (INIS)

Bielejec, E; Seamons, J A; Carroll, M S

2010-01-01

Electronic devices that are designed to use the properties of single atoms such as donors or defects have become a reality with recent demonstrations of donor spectroscopy, single photon emission sources, and magnetic imaging using defect centers in diamond. Ion implantation, an industry standard for atom placement in materials, requires augmentation for single ion capability including a method for detecting a single ion arrival. Integrating single ion detection techniques with the single donor device construction region allows single ion arrival to be assured. Improving detector sensitivity is linked to improving control over the straggle of the ion as well as providing more flexibility in lay-out integration with the active region of the single donor device construction zone by allowing ion sensing at potentially greater distances. Using a remotely located passively gated single ion Geiger mode avalanche diode (SIGMA) detector we have demonstrated 100% detection efficiency at a distance of >75 μm from the center of the collecting junction. This detection efficiency is achieved with sensitivity to ∼600 or fewer electron-hole pairs produced by the implanted ion. Ion detectors with this sensitivity and integrated with a thin dielectric, for example a 5 nm gate oxide, using low energy Sb implantation would have an end of range straggle of -1 and 10 -4 for operation temperatures of ∼300 K and ∼77 K, respectively. Low temperature operation and reduced false, 'dark', counts are critical to achieving high confidence in single ion arrival. For the device performance in this work, the confidence is calculated as a probability of >98% for counting one and only one ion for a false count probability of 10 -4 at an average ion number per gated window of 0.015.

High pulmonary vascular resistance in addition to low right ventricular stroke work index effectively predicts biventricular assist device requirement.

Science.gov (United States)

Imamura, Teruhiko; Kinugawa, Koichiro; Kinoshita, Osamu; Nawata, Kan; Ono, Minoru

2016-03-01

Although the right ventricular stroke work index (RVSWI) is a good index for RV function, a low RVSWI is not necessarily an indicator for the need for a right ventricular assist device at the time of left VAD implantation. We here aimed to determine a more precise indicator for the need for a biventricular assist device (BiVAD). In total, 116 patients (mean age, 38 ± 14 years), who underwent hemodynamic assessments preoperatively including 12 BiVAD patients, and had been followed at our institute from 2003 to 2015, were included. Multivariate logistic regression analysis indicated that RVSWI and pulmonary vascular resistance (PVR) were independent predictors of BiVAD requirement (P 5 g/m, PVR 5, PVR > 3.7), (3) RV failure (RVSWI 3.7), and examined. Most of the patients in Group 4 (75 %), with acutely depressed hemodynamics and inflammatory responses in the myocardium, required BiVAD. Overall, patients with BiVAD had a worse survival rate as compared with those with LVAD alone. In conclusion, high PVR in addition to low RVSWI effectively predicts BiVAD requirement.

Energy transmission and power sources for mechanical circulatory support devices to achieve total implantability.

Science.gov (United States)

Wang, Jake X; Smith, Joshua R; Bonde, Pramod

2014-04-01

Left ventricular assist device therapy has radically improved congestive heart failure survival with smaller rotary pumps. The driveline used to power today's left ventricular assist devices, however, continues to be a source of infection, traumatic damage, and rehospitalization. Previous attempts to wirelessly power left ventricular assist devices using transcutaneous energy transfer systems have been limited by restrictions on separation distance and alignment between the transmit and receive coils. Resonant electrical energy transfer allows power delivery at larger distances without compromising safety and efficiency. This review covers the efforts to wirelessly power mechanical circulatory assist devices and the progress made in enhancing their energy sources. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

When withdrawal of life-sustaining care does more than allow death to take its course: the dilemma of left ventricular assist devices.

Science.gov (United States)

Bramstedt, K A; Wenger, N S

2001-05-01

Left ventricular assist devices (LVADs) are a relatively new technology that is increasingly used to preserve cardiac function. These devices work by a mechanism that may complicate ethical decision-making for patients who subsequently lose decision-making capacity and are no longer considered transplant candidates. Using a clinical case from our medical center, we explored the complex ethical issues associated with the discontinuation of LVAD therapy by discussing how this device is distinct from the withdrawal of other treatments. While halting an implanted LVAD may permit a patient to die, the deactivated device itself may contribute to patient death due to the potential for blood backflow and pooling, as well as the disruption of heart contractility. Inadequate informed consent and failure to appoint a surrogate decision-maker in advance of the implant procedure resulted in a complex ethical dilemma for the patient's family and the medical team. Clinicians and families must consider the benefits and burdens of LVAD therapy as they do when considering removal of other life-sustaining treatment. The informed consent process associated with LVADs as bridging technology should include extensive consideration of the purpose of the device, future circumstances in which it may be halted, and how such situations would be recognized and handled. Appointment of a surrogate decision-maker before the surgical procedure is essential.

Implantable batteryless device for on-demand and pulsatile insulin administration

Science.gov (United States)

Lee, Seung Ho; Lee, Young Bin; Kim, Byung Hwi; Lee, Cheol; Cho, Young Min; Kim, Se-Na; Park, Chun Gwon; Cho, Yong-Chan; Choy, Young Bin

2017-04-01

Many implantable systems have been designed for long-term, pulsatile delivery of insulin, but the lifetime of these devices is limited by the need for battery replacement and consequent replacement surgery. Here we propose a batteryless, fully implantable insulin pump that can be actuated by a magnetic field. The pump is prepared by simple-assembly of magnets and constituent units and comprises a drug reservoir and actuator equipped with a plunger and barrel, each assembled with a magnet. The plunger moves to noninvasively infuse insulin only when a magnetic field is applied on the exterior surface of the body. Here we show that the dose is easily controlled by varying the number of magnet applications. Also, pump implantation in diabetic rats results in profiles of insulin concentration and decreased blood glucose levels similar to those observed in rats treated with conventional subcutaneous insulin injections.

Right heart failure and "failure to thrive" after left ventricular assist device: clinical predictors and outcomes.

Science.gov (United States)

Baumwol, Jay; Macdonald, Peter S; Keogh, Anne M; Kotlyar, Eugene; Spratt, Phillip; Jansz, Paul; Hayward, Christopher S

2011-08-01

This study determined predictors of early post-operative right heart failure (RHF) and its consequences, as well as predictors of those who clinically thrive longer term after insertion of a continuous-flow left ventricular assist device (LVAD). Pre-operative and latest follow-up data were analyzed for 40 consecutive patients who received third-generation centrifugal-flow LVADs. RHF was defined using previously described criteria, including post-operative inotropes, pulmonary vasodilator use, or right-sided mechanical support. Patients were also categorized according to clinical outcomes after LVAD insertion. LVADs were implanted as a bridge to transplantation (BTT) in 33 patients and as destination therapy in 7. Before LVAD implant, 22 patients were Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) level 1, and 17 were at level 2. Temporary mechanical assistance was present in 50% of the cohort at LVAD implantation. The 6-month survival/progression to transplant was 92.5%. Average LVAD support time was 385 days (range, 21-1,011 days). RHF developed postoperatively in 13 of 40 patients (32.5%). RHF patients had more severe pre-operative tricuspid incompetence than non-RHF patients. The BTT patients with evidence of RHF had poorer survival to transplant (6 of 11 [54.5%]) than those without RHF (20 of 22 [90.9%]), p = 0.027). There were no other hemodynamic or echocardiographic predictors of short-term RHF. After LVAD, 22 of the 40 patients (55%) thrived clinically. For BTT patients, 20 of 21 (95%) of those who thrived progressed to transplant or were alive at latest follow-up vs 6 of 12 (50%) of those who failed to thrive (FTT; p thrived. Early post-operative RHF results in poorer survival/progression to transplantation for BTT patients and is predicted by greater pre-operative tricuspid incompetence. The most important predictor for those who will clinically thrive longer-term after LVAD insertion is younger age. Crown Copyright © 2011

Peripheral Artery Disease and Continuous Flow Left Ventricle Assist Device: An Engaging Complement Analysis May Help to Guide Treatment.

Science.gov (United States)

Falletta, Calogero; Pasta, Salvatore; Raffa, Giuseppe Maria; Crinò, Francesca; Sciacca, Sergio; Clemenza, Francesco

2018-02-13

Use of continuous flow left ventricle assist device (CF-LVAD) in advanced heart failure (HF) patients results in clinically relevant improvements in survival, functional capacity, and quality of life. Peripheral artery disease (PAD) can occur in patients with CF-LVAD due to the high rate of concomitance between risk factors for atherosclerosis and HF. Diagnosis of PAD can be difficult in the specific setting of a patient supported by this kind of device because of the marked alteration in waveform morphology and velocity created by the artificial physiology of an LVAD. We report the case of a 53-year-old man with HF secondary to ischemic cardiomyopathy supported by the HeartWare HVAD as bridge to transplant, who after the implant developed symptoms suggestive of PAD. We describe additional computational flow analysis for the study of PAD-related hemodynamic disturbances induced by a CF-LVAD. Flow simulations enhance the information of clinical image data, and may have an application in clinical investigations of the risk of hemodynamic disturbances induced by LVAD implantation. © 2018 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

Science.gov (United States)

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Interconnecting wearable devices with nano-biosensing implants through optical wireless communications

Science.gov (United States)

Johari, Pedram; Pandey, Honey; Jornet, Josep M.

2018-02-01

Major advancements in the fields of electronics, photonics and wireless communication have enabled the development of compact wearable devices, with applications in diverse domains such as fitness, wellness and medicine. In parallel, nanotechnology is enabling the development of miniature sensors that can detect events at the nanoscale with unprecedented accuracy. On this matter, in vivo implantable Surface Plasmon Resonance (SPR) nanosensors have been proposed to analyze circulating biomarkers in body fluids for the early diagnosis of a myriad of diseases, ranging from cardiovascular disorders to different types of cancer. In light of these results, in this paper, an architecture is proposed to bridge the gap between these two apparently disjoint paradigms, namely, the commercial wearable devices and the advanced nano-biosensing technologies. More specifically, this paper thoroughly assesses the feasibility of the wireless optical intercommunications of an SPR-based nanoplasmonic biochip -implanted subcutaneously in the wrist-, with a nanophotonic wearable smart band which is integrated by an array of nano-lasers and photon-detectors for distributed excitation and measurement of the nanoplasmonic biochip. This is done through a link budget analysis which captures the peculiarities of the intra-body optical channel at (sub) cellular level, the strength of the SPR nanosensor reflection, as well as the capabilities of the nanolasers (emission power, spectrum) and the nano photon-detectors (sensitivity and noise equivalent power). The proposed analysis guides the development of practical communication designs between the wearable devices and nano-biosensing implants, which paves the way through early-stage diagnosis of severe diseases.

In vivo evaluation of zirconia ceramic in the DexAide right ventricular assist device journal bearing.

Science.gov (United States)

Saeed, Diyar; Shalli, Shanaz; Fumoto, Hideyuki; Ootaki, Yoshio; Horai, Tetsuya; Anzai, Tomohiro; Zahr, Roula; Horvath, David J; Massiello, Alex L; Chen, Ji-Feng; Dessoffy, Raymond; Catanese, Jacquelyn; Benefit, Stephen; Golding, Leonard A R; Fukamachi, Kiyotaka

2010-06-01

Zirconia is a ceramic with material properties ideal for journal bearing applications. The purpose of this study was to evaluate the use of zirconium oxide (zirconia) as a blood journal bearing material in the DexAide right ventricular assist device. Zirconia ceramic was used instead of titanium to manufacture the DexAide stator housing without changing the stator geometry or the remaining pump hardware components. Pump hydraulic performance, journal bearing reliability, biocompatibility, and motor efficiency data of the zirconia stator were evaluated in six chronic bovine experiments for 14-91 days and compared with data from chronic experiments using the titanium stator. Pump performance data including average in vivo pump flows and speeds using a zirconia stator showed no statistically significant difference to the average values for 16 prior titanium stator in vivo studies, with the exception of a 19% reduction in power consumption. Indices of hemolysis were comparable for both stator types. Results of coagulation assays and platelet aggregation tests for the zirconia stator implants showed no device-induced increase in platelet activation. Postexplant evaluation of the zirconia journal bearing surfaces showed no biologic deposition in any of the implants. In conclusion, zirconia ceramic can be used as a hemocompatible material to improve motor efficiency while maintaining hydraulic performance in a blood journal bearing application.

Comparison of two systems for rigidly connecting 2.0-mm bone screws to an implantable device : in vitro stability testing

NARCIS (Netherlands)

van Loon, JP; de Bont, LGM; Verkerke, GJ

The stability of a screw-fixed implantable device can be improved by eliminating the freedom of movement between the screws and the device. Two systems have been developed for rigidly connecting 2.0-mm bone screws to an implantable device, and the aim of this study was to test and compare the

Management of Retrograde Peri-Implantitis Using an Air-Abrasive Device, Er,Cr:YSGG Laser, and Guided Bone Regeneration

Directory of Open Access Journals (Sweden)

Nikolaos Soldatos

2018-01-01

Full Text Available Background. The placement of an implant in a previously infected site is an important etiologic factor contributing to implant failure. The aim of this case report is to present the management of retrograde peri-implantitis (RPI in a first maxillary molar site, 2 years after the implant placement. The RPI was treated using an air-abrasive device, Er,Cr:YSGG laser, and guided bone regeneration (GBR. Case Description. A 65-year-old Caucasian male presented with a draining fistula associated with an implant at tooth #3. Tooth #3 revealed periapical radiolucency two years before the implant placement. Tooth #3 was extracted, and a ridge preservation procedure was performed followed by implant rehabilitation. A periapical radiograph (PA showed lack of bone density around the implant apex. The site was decontaminated with an air-abrasive device and Er,Cr:YSGG laser, and GBR was performed. The patient was seen every two weeks until suture removal, followed by monthly visits for 12 months. The periapical X-rays, from 6 to 13 months postoperatively, showed increased bone density around the implant apex, with no signs of residual clinical or radiographic pathology and probing depths ≤4 mm. Conclusions. The etiology of RPI in this case was the placement of an implant in a previously infected site. The use of an air-abrasive device, Er,Cr:YSGG, and GBR was utilized to treat this case of RPI. The site was monitored for 13 months, and increased radiographic bone density was noted.

Influence of Implant Position on Stress Distribution in Implant-Assisted Distal Extension Removable Partial Dentures: A 3D Finite Element Analysis.

Science.gov (United States)

Memari, Yeganeh; Geramy, Allahyar; Fayaz, Amir; Rezvani Habib Abadi, Shirin; Mansouri, Yasaman

2014-09-01

Distal extension removable partial denture is a prosthesis with lack of distal dental support with a 13-fold difference in resiliency between the mucosa and the periodontal ligament, resulting in leverage during compression forces. It may be potentially destructive to the abutments and the surrounding tissues. The aim of this study was to assess the effect of implant location on stress distribution, in distal extension implant assisted removable partial dentures. Three-dimensional models of a bilateral distal extension partially edentulous mandible containing anterior teeth and first premolar in both sides of the arch, a partial removable denture and an implant (4×10mm) were designed. With the aid of the finite element program ANSYS 8.0, the models were meshed and strictly vertical forces of 10 N were applied to each cusp tip. Displacement and von Mises Maps were plotted for visualization of results. When an implant was placed in the second premolar region, the highest stress on implant, abutment tooth and cancellous bone was shown. The lowest stress was shown on implant and bone in the 1(st) molar area. Implants located in the first molar area showed the least distribution of stresses in the analyzed models.

Cadaveric feasibility study of da Vinci Si-assisted cochlear implant with augmented visual navigation for otologic surgery.

Science.gov (United States)

Liu, Wen P; Azizian, Mahdi; Sorger, Jonathan; Taylor, Russell H; Reilly, Brian K; Cleary, Kevin; Preciado, Diego

2014-03-01

To our knowledge, this is the first reported cadaveric feasibility study of a master-slave-assisted cochlear implant procedure in the otolaryngology-head and neck surgery field using the da Vinci Si system (da Vinci Surgical System; Intuitive Surgical, Inc). We describe the surgical workflow adaptations using a minimally invasive system and image guidance integrating intraoperative cone beam computed tomography through augmented reality. To test the feasibility of da Vinci Si-assisted cochlear implant surgery with augmented reality, with visualization of critical structures and facilitation with precise cochleostomy for electrode insertion. Cadaveric case study of bilateral cochlear implant approaches conducted at Intuitive Surgical Inc, Sunnyvale, California. Bilateral cadaveric mastoidectomies, posterior tympanostomies, and cochleostomies were performed using the da Vinci Si system on a single adult human donor cadaveric specimen. Radiographic confirmation of successful cochleostomies, placement of a phantom cochlear implant wire, and visual confirmation of critical anatomic structures (facial nerve, cochlea, and round window) in augmented stereoendoscopy. With a surgical mean time of 160 minutes per side, complete bilateral cochlear implant procedures were successfully performed with no violation of critical structures, notably the facial nerve, chorda tympani, sigmoid sinus, dura, or ossicles. Augmented reality image overlay of the facial nerve, round window position, and basal turn of the cochlea was precise. Postoperative cone beam computed tomography scans confirmed successful placement of the phantom implant electrode array into the basal turn of the cochlea. To our knowledge, this is the first study in the otolaryngology-head and neck surgery literature examining the use of master-slave-assisted cochleostomy with augmented reality for cochlear implants using the da Vinci Si system. The described system for cochleostomy has the potential to improve the

Critical Assessment of Implantable Drug Delivery Devices in Glaucoma Management

Directory of Open Access Journals (Sweden)

Dharani Manickavasagam

2013-01-01

Full Text Available Glaucoma is a group of heterogeneous disorders involving progressive optic neuropathy that can culminate into visual impairment and irreversible blindness. Effective therapeutic interventions must address underlying vulnerability of retinal ganglion cells (RGCs to degeneration in conjunction with correcting other associated risk factors (such as elevated intraocular pressure. However, realization of therapeutic outcomes is heavily dependent on suitable delivery system that can overcome myriads of anatomical and physiological barriers to intraocular drug delivery. Development of clinically viable sustained release systems in glaucoma is a widely recognized unmet need. In this regard, implantable delivery systems may relieve the burden of chronic drug administration while potentially ensuring high intraocular drug bioavailability. Presently there are no FDA-approved implantable drug delivery devices for glaucoma even though there are several ongoing clinical studies. The paper critically assessed the prospects of polymeric implantable delivery systems in glaucoma while identifying factors that can dictate (a patient tolerability and acceptance, (b drug stability and drug release profiles, (c therapeutic efficacy, and (d toxicity and biocompatibility. The information gathered could be useful in future research and development efforts on implantable delivery systems in glaucoma.

Three-dimensional finite element analysis of implant-assisted removable partial dentures.

Science.gov (United States)

Eom, Ju-Won; Lim, Young-Jun; Kim, Myung-Joo; Kwon, Ho-Beom

2017-06-01

Whether the implant abutment in implant-assisted removable partial dentures (IARPDs) functions as a natural removable partial denture (RPD) tooth abutment is unknown. The purpose of this 3-dimensional finite element study was to analyze the biomechanical behavior of implant crown, bone, RPD, and IARPD. Finite element models of the partial maxilla, teeth, and prostheses were generated on the basis of a patient's computed tomographic data. The teeth, surveyed crowns, and RPDs were created in the model. With the generated components, four 3-dimensional finite element models of the partial maxilla were constructed: tooth-supported RPD (TB), implant-supported RPD (IB), tooth-tissue-supported RPD (TT), and implant-tissue-supported RPD (IT) models. Oblique loading of 300 N was applied on the crowns and denture teeth. The von Mises stress and displacement of the denture abutment tooth and implant system were identified. The highest von Mises stress values of both IARPDs occurred on the implants, while those of both natural tooth RPDs occurred on the frameworks of the RPDs. The highest von Mises stress of model IT was about twice that of model IB, while the value of model TT was similar to that of model TB. The maximum displacement was greater in models TB and TT than in models IB and IT. Among the 4 models, the highest maximum displacement value was observed in the model TT and the lowest value was in the model IB. Finite element analysis revealed that the stress distribution pattern of the IARPDs was different from that of the natural tooth RPDs and the stress distribution of implant-supported RPD was different from that of implant-tissue-supported RPD. When implants are used for RPD abutments, more consideration concerning the RPD design and the number or location of the implant is necessary. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

The pharmacotherapy of the HeartMate II, a continuous flow left ventricular assist device, in patients with advanced heart failure: integration of disease, device, and drug.

Science.gov (United States)

Jennings, Douglas L; Chambers, Rachel M; Schillig, Jessica M

2010-10-01

Advanced heart failure continues to be a significant cause of morbidity and mortality in the US. Patients with advanced heart failure have a poor prognosis without cardiac transplantation. The use of left ventricular assist devices (LVADs) as destination therapy for these patients is therefore expected to increase in the coming years as technology advances. The HeartMate II, a continuous flow implantable device, is currently the only LVAD that has been approved by the Food and Drug Administration for destination therapy in patients with advanced heart failure. The pharmacotherapy associated with this device is very complex and, therefore, the need for expertly trained clinical pharmacists to care for this expanding patient population will also likely increase. Unfortunately, most pharmacists are unfamiliar with the effect of LVADs on the physiology and pharmacotherapy of a patient's heart failure. The purpose of this article is to give clinical pharmacists an introduction to the most common pharmacotherapeutic issues for patients with LVADs and present practical solutions for managing common drug therapy problems.

Short-term retrospective case series of implant-assisted removable partial dentures with locator abutments.

Science.gov (United States)

Ortiz-Puigpelat, Octavi; Gargallo-Albiol, Jordi; Hernández-Alfaro, Federico; Cabratosa-Termes, Josep

2014-01-01

The purpose of this retrospective case series was to report on the clinical performance of implant-assisted removable partial dentures (IARPDs) with Locator abutments in different partial edentulism situations, with a mean follow-up period of 28.6 months. Twelve consecutive patients were treated with IARPDs. A total of 24 implants were placed in the edentulous area. Minimum follow-up period was 12 months. Overall patient satisfaction, health of peri-implant tissues, survival of implants and abutments, and prosthetic complications were reported. Overall implant survival was 91.6%; two implants failed. No major complications were reported-only one IARPD metal framework broke. No Locator abutment loosening was reported. Within the limitations of this retrospective study, treatment with IARPDs can improve the patient's function, phonetics, and esthetics without the need for extensive bone regeneration surgeries and prosthodontic rehabilitations. However, well-designed prospective clinical studies on IARPDs are needed to support their long-term use.

Biocompatible implants and methods of making and attaching the same

Energy Technology Data Exchange (ETDEWEB)

Rowley, Adrian P; Laude, Lucien D; Humayun, Mark S; Weiland, James D; Lotfi, Atoosa; Markland, Jr., Francis S

2014-10-07

The invention provides a biocompatible silicone implant that can be securely affixed to living tissue through interaction with integral membrane proteins (integrins). A silicone article containing a laser-activated surface is utilized to make the implant. One example is an implantable prosthesis to treat blindness caused by outer retinal degenerative diseases. The device bypasses damaged photoreceptors and electrically stimulates the undamaged neurons of the retina. Electrical stimulation is achieved using a silicone microelectrode array (MEA). A safe, protein adhesive is used in attaching the MEA to the retinal surface and assist in alleviating focal pressure effects. Methods of making and attaching such implants are also provided.

Heat Generation in Axial and Centrifugal Flow Left Ventricular Assist Devices.

Science.gov (United States)

Yost, Gardner; Joseph, Christine Rachel; Royston, Thomas; Tatooles, Antone; Bhat, Geetha

Despite increasing use of left ventricular assist devices (LVADs) as a surgical treatment for advanced heart failure in an era of improved outcomes with LVAD support, the mechanical interactions between these pumps and the cardiovascular system are not completely understood. We utilized an in vitro mock circulatory loop to analyze the heat production incurred by operation of an axial flow and centrifugal flow LVAD. A HeartMate II and a HeartWare HVAD were connected to an abbreviated flow loop and were implanted in a viscoelastic gel. Temperature was measured at the surface of each LVAD. Device speed and fluid viscosity were altered and, in the HeartMate II, as artificial thrombi were attached to the inflow stator, impeller, and outflow stator. The surface temperatures of both LVADs increased in all trials and reached a plateau within 80 minutes of flow initiation. Rate of heat generation and maximum system temperature were greater when speed was increased, when viscosity was increased, and when artificial thrombi were attached to the HeartMate II impeller. Normal operation of these two widely utilized LVADs results in appreciable heat generation in vitro. Increased pump loading resulted in more rapid heat generation, which was particularly severe when a large thrombus was attached to the impeller of the HeartMate II. While heat accumulation in vivo is likely minimized by greater dissipation in the blood and soft tissues, focal temperature gains with the pump housing of these two devices during long-term operation may have negative hematological consequences.

Post-transplant outcomes in pediatric ventricular assist device patients: A PediMACS-Pediatric Heart Transplant Study linkage analysis.

Science.gov (United States)

Sutcliffe, David L; Pruitt, Elizabeth; Cantor, Ryan S; Godown, Justin; Lane, John; Turrentine, Mark W; Law, Sabrina P; Lantz, Jodie L; Kirklin, James K; Bernstein, Daniel; Blume, Elizabeth D

2017-12-13

Pediatric ventricular assist device (VAD) support as bridge to transplant has improved waitlist survival, but the effects of pre-implant status and VAD-related events on post-transplant outcomes have not been assessed. This study is a linkage analysis between the PediMACS and Pediatric Heart Transplant Study databases to determine the effects of VAD course on post-transplant outcomes. Database linkage between October 1, 2012 and December 31, 2015 identified 147 transplanted VAD patients, the primary study group. The comparison cohort was composed of 630 PHTS patients without pre-transplant VAD support. The primary outcome was post-transplant survival, with secondary outcomes of post-transplant length of stay, freedom from infection and freedom from rejection. At implant, the VAD cohort was INTERMACS Profile 1 in 33 (23%), Profile 2 in 89 (63%) and Profile 3 in 14 (10%) patients. The VAD cohort was older, larger, and less likely to have congenital heart disease (p < 0.0001). However, they had greater requirements for inotrope and ventilator support and increased liver and renal dysfunction (p < 0.0001), both of which normalized at transplant after device support. Importantly, there were no differences in 1-year post-transplant survival (96% vs 93%, p = 0.3), freedom from infection (81% vs 79%, p = 0.9) or freedom from rejection (71% vs 74%, p = 0.87) between cohorts. Pediatric VAD patients have post-transplant outcomes equal to that of medically supported patients, despite greater pre-implant illness severity. Post-transplant survival, hospital length of stay, infection and rejection were not affected by patient acuity at VAD implantation or VAD-related complications. Therefore, VAD as bridge to transplant mitigates severity of illness in children. Copyright © 2017 International Society for the Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Follow-up of Temporary Implantable Nitinol Device (TIND) Implantation for the Treatment of BPH: a Systematic Review.

Science.gov (United States)

Bertolo, Riccardo; Fiori, Cristian; Amparore, Daniele; Porpiglia, Francesco

2018-04-26

The purpose of the present systematic review is to offer a narrative synthesis of the available literature regarding the role of the temporary implantable nitinol device (TIND) (Medi-Tate®; Medi-Tate Ltd., Or Akiva, Israel) for the treatment of benign prostatic hyperplasia (BPH)-related lower urinary tract symptoms (LUTS), specifically focusing on the follow-up data. Current available evidences are limited in this topic. Sample size of patients available for analysis is small. Moreover, the duration of follow-up period is intermediate and longer follow-up is required. At the available 3 years follow-up, the TIND implantation is safe, effective, and well tolerated. The extended follow-up of the first and only available cohort of patients who underwent TIND for LUTS related to BPH corroborated previous literature findings. Further studies are required in order to assess the durability of TIND outcomes over a longer follow-up, to better define the indications of this approach, and to demonstrate the advantages of second-generation device over the first.

Multicentre prospective evaluation of implant-assisted mandibular removable partial dentures: surgical and prosthodontic outcomes.

Science.gov (United States)

Payne, Alan G T; Tawse-Smith, Andrew; Wismeijer, Daniel; De Silva, Rohana K; Ma, Sunyoung

2017-01-01

To determine implant survival and prosthodontic maintenance of implant-assisted mandibular removable partial dentures in a multicentre prospective study up to 10 years. Forty-eight participants with mandibular distal extension partial dentures were selected. A control group of 12 New Zealand participants had new conventional mandibular partial dentures made. Three test groups of 36 participants in New Zealand (n = 12), the Netherlands (n = 12) and Colombia (n = 12) had bilateral distal implants placed. Surgical and prosthodontic outcomes were documented with only healing caps placed (Stage 1) and with an attachment system (Stage 2). No implants failed after 3 years. Four late implant failures in three participants occurred in New Zealand (two unilateral implant failures after 5 and 8 years and two bilateral implant failures in the same participant after 6 and 10 years); two unilateral late implant failures occurred in the Netherlands and no late failures in Colombia. Implant survival rate was 92% by 10 years. Resonance frequency measurements were taken at surgery implant stability quotient (ISQ) 62.44 ± 7.46; range 40 - 79), baseline (ISQ 63.22 ± 6.17; range 50 - 74) and after 3 years (ISQ 66.38 ± 6.77; range 55 - 83). In New Zealand and Colombia, measured crestal bone levels were 2.03 ± 0.71 mm and 2.20 ± 0.81 mm, respectively, at baseline and 3 years. For Stage I, principal prosthodontic maintenance issues were loose healing caps among 10 New Zealand participants, four Colombian participants and one Netherlands participant. For Stage 2, matrix activation and overdenture puncture fractures resulted in 41 events (25 participants) in New Zealand over 10 years, whilst over 3 years, there were 14 events in nine Colombian participants and six events in five Netherlands participants. This clinical multicentre research complements previous case reports, case series, retrospective and prospective studies on the notion of implant-assisted

Device-length changes and implant function following surgical implantation of the KineSpring in cadaver knees

Directory of Open Access Journals (Sweden)

McNicholas MJ

2015-01-01

Full Text Available Michael J McNicholas,1 Stefan M Gabriel,2 Anton G Clifford,2 Evelyne M Hasler2 1Aintree University Hospital, Teaching Hospital, Major Trauma Centre, NHS Foundation Trust, Liverpool, UK; 2Moximed, Hayward, CA, USA Introduction: The KineSpring implant system has been shown to provide load reductions at the medial compartment of the knee, and has demonstrated clinical success in reducing pain and increasing function in patients with medial knee osteoarthritis. These results depend on the ability of the KineSpring to rotate, lengthen, and shorten to accommodate knee motions, and in response to knee position and loading. Purpose: The present study was undertaken to determine length changes of the implanted KineSpring in response to a range of knee positions, external knee loads, and placements by different orthopedic surgeons. Materials and methods: KineSpring system components were implanted in ten cadaver leg specimens by ten orthopedic surgeons, and absorber-length changes were measured under combined loading and in different positions of the knee. Results and conclusion: Spring compression consistent with knee-load reduction, and device lengthening and shortening to accommodate knee loads and motions were seen. These confirm the functionality of the KineSpring when implanted medially to the knee. Keywords: KineSpring, knee, function, preservation, offloading, osteoarthritis

Implementation of a transcutaneous charger for fully implantable middle ear hearing device.

Science.gov (United States)

Lim, H; Yoon, Y; Lee, C; Park, I; Song, B; Cho, J

2005-01-01

A transcutaneous charger for the fully implantable middle ear hearing device (F-IMEHD), which can monitor the charging level of battery, has been designed and implemented. In order to recharge the battery of F-IMEHD, the electromagnetic coupling between primary coil at outer body and secondary coil at inner body has been used. Considering the implant condition of the F-IMEHD, the primary coil and the secondary coil have been designed. Using the resonance of LC tank circuit at each coil, transmission efficiency was increased. Since the primary and the secondary coil are magnetically coupled, the current variation of the primary coil is related with the impedance of internal resonant circuit. Using the principle mentioned above, the implanted module could transmit outward the information about charging state of battery or coupling between two coils by the changing internal impedance. As in the demonstrated results of experiment, the implemented charger has supplied the sufficient operating voltage for the implanted battery within about 10 mm distance. And also, it has been confirmed that the implanted module can transmit information outward by control of internal impedance.

A difficult decision: what should we do when malignant tumours are diagnosed in patients supported by left ventricular assist devices?

Science.gov (United States)

Smail, Hassiba; Pfister, Christian; Baste, Jean-Marc; Nafeh-Bizet, Catherine; Gay, Arnaud; Barbay, Virginie; Bessou, Jean-Paul; Peillon, Christophe; Litzler, Pierre-Yves

2015-09-01

Left ventricular assist devices (LVADs) are used as a bridge to heart transplantation. During the preimplantation or pretransplantation screening, malignant tumours can be discovered. Owing to the lack of guidelines, the management is difficult. We describe our perioperative approach and the patients' outcomes. Between 2006 and 2014, 55 patients underwent implantation of HeartMate II LVAD. Five were diagnosed with malignant tumours: 2 renal, 2 lung and 1 breast tumours. The renal tumours were diagnosed during the preimplantation screening. An LVAD was implanted in both followed by partial nephrectomies 8 and 9 months later. The lung cancers were diagnosed after device implantation, a left pulmonary segmentectomy and a right upper sleeve lobectomy were performed. The breast cancer was diagnosed few months after support and a tumourectomy with lymphadenectomy was performed. Tumour resection was performed successfully in all patients. Prior to surgery haemostasis, device and heart function were evaluated. During surgery, haemodynamics and anticoagulation were monitored. Reoperations were necessary to evacuate haemothorax after lobectomy and an abdominal haematoma post-nephrectomy. After discussion with oncologists, 3 patients were relisted for heart transplantation. Two were successfully transplanted 2 and 3 years after partial nephrectomy with an actual survival of 56 and 59 months after the cancer diagnosis. The follow-up revealed no cancer recurrences. Malignant tumours during support with LVAD can be successfully resected. A multidisciplinary evaluation in these high-risk patients is mandatory. After careful evaluation, regaining the patient's heart transplant candidacy is possible. © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Impact of tricuspid valve surgery at the time of left ventricular assist device insertion on postoperative outcomes.

Science.gov (United States)

Dunlay, Shannon M; Deo, Salil V; Park, Soon J

2015-01-01

Tricuspid regurgitation (TR) is common in patients with heart failure undergoing left ventricular assist device (LVAD) implantation. Whether the TR should be surgically managed at the time of LVAD surgery is controversial. We searched SCOPUS, Web of Science, Ovid EMBASE, and Ovid MEDLINE (through May 10, 2014) for randomized controlled trials and observational studies comparing postoperative outcomes in patients treated with LVAD with concomitant tricuspid valve surgery (TVS) compared with LVAD alone. Six observational studies including 3,249 patients compared outcomes following LVAD + TVS versus LVAD. Four studies were single-center and most did not adjust for potential confounders. Addition of TVS prolonged cardiopulmonary bypass times by an average of 31 minutes (three studies, 95% CI 20-42). There was no difference in need for right ventricular assist device (six studies, HR 1.42, 95% CI 0.54-3.76), acute renal failure (four studies, HR 1.07, 95% CI 0.55-2.10), or early mortality (six studies, HR 1.28, 95% CI 0.78-2.08) in patients treated with LVAD + TVS versus LVAD alone. TVS prolongs cardiopulmonary bypass times, but available data demonstrate no significant association with early postoperative outcomes. However, differences in baseline risk of patients treated with TVS versus not limit our ability to draw conclusions.

Accelerated life-test methods and results for implantable electronic devices with adhesive encapsulation.

Science.gov (United States)

Huang, Xuechen; Denprasert, Petcharat May; Zhou, Li; Vest, Adriana Nicholson; Kohan, Sam; Loeb, Gerald E

2017-09-01

We have developed and applied new methods to estimate the functional life of miniature, implantable, wireless electronic devices that rely on non-hermetic, adhesive encapsulants such as epoxy. A comb pattern board with a high density of interdigitated electrodes (IDE) could be used to detect incipient failure from water vapor condensation. Inductive coupling of an RF magnetic field was used to provide DC bias and to detect deterioration of an encapsulated comb pattern. Diodes in the implant converted part of the received energy into DC bias on the comb pattern. The capacitance of the comb pattern forms a resonant circuit with the inductor by which the implant receives power. Any moisture affects both the resonant frequency and the Q-factor of the resonance of the circuitry, which was detected wirelessly by its effects on the coupling between two orthogonal RF coils placed around the device. Various defects were introduced into the comb pattern devices to demonstrate sensitivity to failures and to correlate these signals with visual inspection of failures. Optimized encapsulation procedures were validated in accelerated life tests of both comb patterns and a functional neuromuscular stimulator under development. Strong adhesive bonding between epoxy and electronic circuitry proved to be necessary and sufficient to predict 1 year packaging reliability of 99.97% for the neuromuscular stimulator.

Influence of Implant Position on Stress Distribution in Implant-Assisted Distal Extension Removable Partial Dentures: A 3D Finite Element Analysis.

Directory of Open Access Journals (Sweden)

Yeganeh Memari

2014-10-01

Full Text Available Distal extension removable partial denture is a prosthesis with lack of distal dental support with a 13-fold difference in resiliency between the mucosa and the periodontal ligament, resulting in leverage during compression forces. It may be potentially destructive to the abutments and the surrounding tissues. The aim of this study was to assess the effect of implant location on stress distribution, in distal extension implant assisted removable partial dentures.Three-dimensional models of a bilateral distal extension partially edentulous mandible containing anterior teeth and first premolar in both sides of the arch, a partial removable denture and an implant (4×10mm were designed. With the aid of the finite element program ANSYS 8.0, the models were meshed and strictly vertical forces of 10 N were applied to each cusp tip. Displacement and von Mises Maps were plotted for visualization of results.When an implant was placed in the second premolar region, the highest stress on implant, abutment tooth and cancellous bone was shown. The lowest stress was shown on implant and bone in the 1(st molar area.Implants located in the first molar area showed the least distribution of stresses in the analyzed models.

78 FR 34922 - Definition of Auditory Assistance Device

Science.gov (United States)

2013-06-11

... permitting such use of these devices would increase the comprehension of persons that need language... communications (including but not limited to applications such as assistive listening, auricular training, audio...

X-ray exposure hazards for physicians performing ablation procedures and device implantation

DEFF Research Database (Denmark)

Marinskis, Germanas; Bongiorni, Maria Grazia; Dagres, Nikolaos

2013-01-01

The purpose of the survey was to evaluate physician's and authorities policies and clinical practices when using occupational X-ray during ablation procedures and device implantation. This survey shows infrequent use of lead gloves, radiation absorbing pads, and lead glass cabins, but increasing ...

Magnetic suspension of the rotor of a ventricular assist device of mixed flow type.

Science.gov (United States)

Horikawa, Oswaldo; de Andrade, Aron José Pazin; da Silva, Isaías; Bock, Eduardo Guy Perpetuo

2008-04-01

This work presents results of preliminary studies concerning application of magnetic bearing in a ventricular assist device (VAD) being developed by Dante Pazzanese Institute of Cardiology-IDPC (São Paulo, Brazil). The VAD-IDPC has a novel architecture that distinguishes from other known VADs. In this, the rotor has a conical geometry with spiral impellers, showing characteristics that are intermediate between a centrifugal VAD and an axial VAD. The effectiveness of this new type of blood pumping principle was showed by tests and by using it in heart surgery for external blood circulation. However, the developed VAD uses a combination of ball bearings and mechanical seals, limiting the life for some 10 h, making impossible its long-term use or its use as an implantable VAD. As a part of development of an implantable VAD, this work aims at the replacement of ball bearings by a magnetic bearing. The most important magnetic bearing principles are studied and the magnetic bearing developed by Escola Politécnica of São Paulo University (EPUSP-MB) is elected because of its very simple architecture. Besides presenting the principle of the EPUSP-MB, this work presents one possible alternative for applying the EPUSP-MB in the IDPC-VAD.

Assistive acting movement therapy devices with pneumatic rotary-type soft actuators.

Science.gov (United States)

Wilkening, André; Baiden, David; Ivlev, Oleg

2012-12-01

Inherent compliance and assistive behavior are assumed to be essential properties for safe human-robot interaction. Rehabilitation robots demand the highest standards in this respect because the machine interacts directly with weak persons who are often sensitive to pain. Using novel soft fluidic actuators with rotary elastic chambers (REC actuators), compact, lightweight, and cost-effective therapeutic devices can be developed. This article describes modular design and control strategies for new assistive acting robotic devices for upper and lower extremities. Due to the inherent compliance and natural back-drivability of pneumatic REC actuators, these movement therapy devices provide gentle treatment, whereby the interaction forces between humans and the therapy device are estimated without the use of expensive force/torque sensors. An active model-based gravity compensation based on separated models of the robot and of the individual patient's extremity provides the basis for effective assistive control. The utilization of pneumatic actuators demands a special safety concept, which is merged with control algorithms to provide a sufficient level of safeness and to catch any possible system errors and/or emergency situations. A self-explanatory user interface allows for easy, intuitive handling. Prototypes are very comfortable for use due to several control routines that work in the background. Assistive devices have been tested extensively with several healthy persons; the knee/hip movement therapy device is now under clinical trials at the Clinic for Orthopaedics and Trauma Surgery at the Klinikum Stuttgart.

From assistance towards restoration with epidural brain-computer interfacing.

Science.gov (United States)

Gharabaghi, Alireza; Naros, Georgios; Walter, Armin; Grimm, Florian; Schuermeyer, Marc; Roth, Alexander; Bogdan, Martin; Rosenstiel, Wolfgang; Birbaumer, Niels

2014-01-01

Today's implanted brain-computer interfaces make direct contact with the brain or even penetrate the tissue, bearing additional risks with regard to safety and stability. What is more, these approaches aim to control prosthetic devices as assistive tools and do not yet strive to become rehabilitative tools for restoring lost motor function. We introduced a less invasive, implantable interface by applying epidural electrocorticography in a chronic stroke survivor with a persistent motor deficit. He was trained to modulate his natural motor-related oscillatory brain activity by receiving online feedback. Epidural recordings of field potentials in the beta-frequency band projecting onto the anatomical hand knob proved most successful in discriminating between the attempt to move the paralyzed hand and to rest. These spectral features allowed for fast and reliable control of the feedback device in an online closed-loop paradigm. Only seven training sessions were required to significantly improve maximum wrist extension. For patients suffering from severe motor deficits, epidural implants may decode and train the brain activity generated during attempts to move with high spatial resolution, thus facilitating specific and high-intensity practice even in the absence of motor control. This would thus transform them from pure assistive devices to restorative tools in the context of reinforcement learning and neurorehabilitation.

Influence of surgical implantation angle of left ventricular assist device outflow graft and management of aortic valve opening on the risk of stroke in heart failure patients

Science.gov (United States)

Chivukula, V. Keshav; McGah, Patrick; Prisco, Anthony; Beckman, Jennifer; Mokadam, Nanush; Mahr, Claudius; Aliseda, Alberto

2016-11-01

Flow in the aortic vasculature may impact stroke risk in patients with left ventricular assist devices (LVAD) due to severely altered hemodynamics. Patient-specific 3D models of the aortic arch and great vessels were created with an LVAD outflow graft at 45, 60 and 90° from centerline of the ascending aorta, in order to understand the effect of surgical placement on hemodynamics and thrombotic risk. Intermittent aortic valve opening (once every five cardiac cycles) was simulated and the impact of this residual native output investigated for the potential to wash out stagnant flow in the aortic root region. Unsteady CFD simulations with patient-specific boundary conditions were performed. Particle tracking for 10 cardiac cycles was used to determine platelet residence times and shear stress histories. Thrombosis risk was assessed by a combination of Eulerian and Lagrangian metrics and a newly developed thrombogenic potential metric. Results show a strong influence of LVAD outflow graft angle on hemodynamics in the ascending aorta and consequently on stroke risk, with a highly positive impact of aortic valve opening, even at low frequencies. Optimization of LVAD implantation and management strategies based on patient-specific simulations to minimize stroke risk will be presented

Retrograde Colonic Stent Implantation Assisted by Percutaneous Colostomy: A Case Report

Energy Technology Data Exchange (ETDEWEB)

Lim, Hyoung Gun; Han, Hyun Young; Chun, Tong Jin [Eulji Medical Center, Seoul (Korea, Republic of)

2009-10-15

We present a patient with disseminated pancreatic cancer who presented with symptoms of acute obstruction of the sigmoid colon. It was not possible to pass the region of the obstruction with a guide wire under colonoscopy and fluoroscopy. Consequently retrograde implantation of stents was performed successfully with the assistance of a minimally-sized colostomy when compared with a previously described procedure in the literature.

Retrograde Colonic Stent Implantation Assisted by Percutaneous Colostomy: A Case Report

International Nuclear Information System (INIS)

Lim, Hyoung Gun; Han, Hyun Young; Chun, Tong Jin

2009-01-01

We present a patient with disseminated pancreatic cancer who presented with symptoms of acute obstruction of the sigmoid colon. It was not possible to pass the region of the obstruction with a guide wire under colonoscopy and fluoroscopy. Consequently retrograde implantation of stents was performed successfully with the assistance of a minimally-sized colostomy when compared with a previously described procedure in the literature

Design of an Implantable Device for Ocular Drug Delivery

Directory of Open Access Journals (Sweden)

Jae-Hwan Lee

2012-01-01

Full Text Available Ocular diseases, such as, glaucoma, age-related macular degeneration (AMD, diabetic retinopathy, and retinitis pigmentosa require drug management in order to prevent blindness and affecting million of adults in USA and worldwide. There is an increasing need to develop devices for drug delivery to address ocular diseases. This study focuses on the design, simulation, and development of an implantable ocular drug delivery device consisting of micro-/nanochannels embedded between top and bottom covers with a drug reservoir made from polydimethylsiloxane (PDMS which is silicon-based organic and biodegradable polymer. Several simulations were carried out with six different micro-channel configurations in order to see the feasibility for ocular drug delivery applications. Based on the results obtained, channel design of osmotic I and osmotic II satisfied the diffusion rates required for ocular drug delivery. Finally, a prototype illustrating the three components of the drug delivery design is presented. In the future, the device will be tested for its functionality and diffusion characteristics.

Design and Development of a Miniaturized Percutaneously Deployable Wireless Left Ventricular Assist Device: Early Prototypes and Feasibility Testing.

Science.gov (United States)

Letzen, Brian; Park, Jiheum; Tuzun, Zeynep; Bonde, Pramod

The current left ventricular assist devices (LVADs) are limited by a highly invasive implantation procedure in a severely unstable group of advanced heart failure patients. Additionally, the current transcutaneous power drive line acts as a nidus for infection resulting in significant morbidity and mortality. In an effort to decrease this invasiveness and eliminate drive line complications, we have conceived a wireless miniaturized percutaneous LVAD, capable of being delivered endovascularly with a tether-free operation. The system obviates the need for a transcutaneous fluid purge line required in existing temporary devices by utilizing an incorporated magnetically coupled impeller for a complete seal. The objective of this article was to demonstrate early development and proof-of-concept feasibility testing to serve as the groundwork for future formalized device development. Five early prototypes were designed and constructed to iteratively minimize the pump size and improve fluid dynamic performance. Various magnetic coupling configurations were tested. Using SolidWorks and ANSYS software for modeling and simulation, several geometric parameters were varied. HQ curves were constructed from preliminary in vitro testing to characterize the pump performance. Bench top tests showed no-slip magnetic coupling of the impeller to the driveshaft up to the current limit of the motor. The pump power requirements were tested in vitro and were within the appropriate range for powering via a wireless energy transfer system. Our results demonstrate the proof-of-concept feasibility of a novel endovascular cardiac assist device with the potential to eventually offer patients an untethered, minimally invasive support.

The Challenges of Balancing Safety and Security in Implantable Medical Devices.

Science.gov (United States)

Katzis, Konstantinos; Jones, Richard W; Despotou, George

2016-01-01

Modern Implantable Medical Devices (IMDs), implement capabilities that have contributed significantly to patient outcomes, as well as quality of life. The ever increasing connectivity of IMD's does raise security concerns though there are instances where implemented security measures might impact on patient safety. The paper discusses challenges of addressing both of these attributes in parallel.

Evaluation of biofouling in stainless microfluidic channels for implantable multilayered dialysis device

Science.gov (United States)

Ota, Takashi; To, Naoya; Kanno, Yoshihiko; Miki, Norihisa

2017-06-01

An implantable artificial kidney can markedly improve the quality of life of renal disease patients. Our group has developed an implantable multilayered dialysis system consisting of microfluidic channels and dialysis membranes. Long-term evaluation is necessary for implant devices where biofouling is a critical factor, culminating in the deterioration of dialysis performance. Our previous work revealed that surface conditions, which depend on the manufacturing process, determine the amount of biofouling, and that electrolytic etching is the most suitable technique for forming a channel wall free of biofouling. In this study, we investigated the electrolytic etching conditions in detail. We conducted in vitro experiments for 7 d and evaluated the adhesion of biomaterials by scanning electron microscopy. The experiments revealed that a surface mirror-finished by electrolytic etching effectively prevents biofouling.

An implantable thermoresponsive drug delivery system based on Peltier device.

Science.gov (United States)

Yang, Rongbing; Gorelov, Alexander V; Aldabbagh, Fawaz; Carroll, William M; Rochev, Yury

2013-04-15

Locally dropping the temperature in vivo is the main obstacle to the clinical use of a thermoresponsive drug delivery system. In this paper, a Peltier electronic element is incorporated with a thermoresponsive thin film based drug delivery system to form a new drug delivery device which can regulate the release of rhodamine B in a water environment at 37 °C. Various current signals are used to control the temperature of the cold side of the Peltier device and the volume of water on top of the Peltier device affects the change in temperature. The pulsatile on-demand release profile of the model drug is obtained by turning the current signal on and off. The work has shown that the 2600 mAh power source is enough to power this device for 1.3 h. Furthermore, the excessive heat will not cause thermal damage in the body as it will be dissipated by the thermoregulation of the human body. Therefore, this simple novel device can be implanted and should work well in vivo. Copyright © 2013 Elsevier B.V. All rights reserved.

Preventing bacterial growth on implanted device with an interfacial metallic film and penetrating X-rays.

Science.gov (United States)

An, Jincui; Sun, An; Qiao, Yong; Zhang, Peipei; Su, Ming

2015-02-01

Device-related infections have been a big problem for a long time. This paper describes a new method to inhibit bacterial growth on implanted device with tissue-penetrating X-ray radiation, where a thin metallic film deposited on the device is used as a radio-sensitizing film for bacterial inhibition. At a given dose of X-ray, the bacterial viability decreases as the thickness of metal film (bismuth) increases. The bacterial viability decreases with X-ray dose increases. At X-ray dose of 2.5 Gy, 98% of bacteria on 10 nm thick bismuth film are killed; while it is only 25% of bacteria are killed on the bare petri dish. The same dose of X-ray kills 8% fibroblast cells that are within a short distance from bismuth film (4 mm). These results suggest that penetrating X-rays can kill bacteria on bismuth thin film deposited on surface of implant device efficiently.

Implantation in assisted reproduction: a look at endometrial receptivity.

Science.gov (United States)

Fatemi, H M; Popovic-Todorovic, B

2013-11-01

Implantation failure in assisted reproduction is thought to be mainly due to impaired uterine receptivity. With normal uterine anatomy, changes in endocrine profile during ovarian stimulation and medical conditions of the mother (i.e. thrombophilia and abnormal immunological response) could result in a non-receptive endometrium. High oestradiol concentrations during ovarian stimulation lead to premature progesterone elevation, causing endometrial advancement and hampering implantation, which can be overcome by a freeze-all approach and embryo transfer in natural cycles or by milder stimulation protocols. Patients with recurrent implantation failure (RIF) should be tested for inherited and acquired thrombophilias. Each patient should be individually assessed and counselled regarding therapy with low-molecular-weight heparin (LMWH). Empirical treatment with LMWH, aspirin or corticosteroids is not effective for women with RIF who have negative thrombophilic tests. If thrombophilic tests are normal, patients should be tested for immunological causes. If human leukocyte antigen dissimilarity is proven, treatment with intravenous immunoglobulin might be beneficial. Preliminary observational studies using intralipid infusion in the presence of increased natural killer cytotoxic activity are interesting but the proposed rationale is controversial and randomized controlled trials are needed. Hysteroscopy and/or endometrial scratching in the cycle preceding ovarian stimulation should become standard for patients with RIF. Copyright © 2013 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

A flexible super-capacitive solid-state power supply for miniature implantable medical devices.

Science.gov (United States)

Meng, Chuizhou; Gall, Oren Z; Irazoqui, Pedro P

2013-12-01

We present a high-energy local power supply based on a flexible and solid-state supercapacitor for miniature wireless implantable medical devices. Wireless radio-frequency (RF) powering recharges the supercapacitor through an antenna with an RF rectifier. A power management circuit for the super-capacitive system includes a boost converter to increase the breakdown voltage required for powering device circuits, and a parallel conventional capacitor as an intermediate power source to deliver current spikes during high current transients (e.g., wireless data transmission). The supercapacitor has an extremely high area capacitance of ~1.3 mF/mm(2), and is in the novel form of a 100 μm-thick thin film with the merit of mechanical flexibility and a tailorable size down to 1 mm(2) to meet various clinical dimension requirements. We experimentally demonstrate that after fully recharging the capacitor with an external RF powering source, the supercapacitor-based local power supply runs a full system for electromyogram (EMG) recording that consumes ~670 μW with wireless-data-transmission functionality for a period of ~1 s in the absence of additional RF powering. Since the quality of wireless powering for implantable devices is sensitive to the position of those devices within the RF electromagnetic field, this high-energy local power supply plays a crucial role in providing continuous and reliable power for medical device operations.

Mechanical stability of custom-made implants: Numerical study of anatomical device and low elastic Young's modulus alloy.

Science.gov (United States)

Didier, P; Piotrowski, B; Fischer, M; Laheurte, P

2017-05-01

The advent of new manufacturing technologies such as additive manufacturing deeply impacts the approach for the design of medical devices. It is now possible to design custom-made implants based on medical imaging, with complex anatomic shape, and to manufacture them. In this study, two geometrical configurations of implant devices are studied, standard and anatomical. The comparison highlights the drawbacks of the standard configuration, which requires specific forming by plastic strain in order to be adapted to the patient's morphology and induces stress field in bones without mechanical load in the implant. The influence of low elastic modulus of the materials on stress distribution is investigated. Two biocompatible alloys having the ability to be used with SLM additive manufacturing are considered, commercial Ti-6Al-4V and Ti-26Nb. It is shown that beyond the geometrical aspect, mechanical compatibility between implants and bones can be significantly improved with the modulus of Ti-26Nb implants compared with the Ti-6Al-4V. Copyright © 2016 Elsevier B.V. All rights reserved.

Results of remote follow-up and monitoring in young patients with cardiac implantable electronic devices.

Science.gov (United States)

Silvetti, Massimo S; Saputo, Fabio A; Palmieri, Rosalinda; Placidi, Silvia; Santucci, Lorenzo; Di Mambro, Corrado; Righi, Daniela; Drago, Fabrizio

2016-01-01

Remote monitoring is increasingly used in the follow-up of patients with cardiac implantable electronic devices. Data on paediatric populations are still lacking. The aim of our study was to follow-up young patients both in-hospital and remotely to enhance device surveillance. This is an observational registry collecting data on consecutive patients followed-up with the CareLink system. Inclusion criteria were a Medtronic device implanted and patient's willingness to receive CareLink. Patients were stratified according to age and presence of congenital/structural heart defects (CHD). A total of 221 patients with a device - 200 pacemakers, 19 implantable cardioverter defibrillators, and two loop recorders--were enrolled (median age of 17 years, range 1-40); 58% of patients were younger than 18 years of age and 73% had CHD. During a follow-up of 12 months (range 4-18), 1361 transmissions (8.9% unscheduled) were reviewed by technicians. Time for review was 6 ± 2 minutes (mean ± standard deviation). Missed transmissions were 10.1%. Events were documented in 45% of transmissions, with 2.7% yellow alerts and 0.6% red alerts sent by wireless devices. No significant differences were found in transmission results according to age or presence of CHD. Physicians reviewed 6.3% of transmissions, 29 patients were contacted by phone, and 12 patients underwent unscheduled in-hospital visits. The event recognition with remote monitoring occurred 76 days (range 16-150) earlier than the next scheduled in-office follow-up. Remote follow-up/monitoring with the CareLink system is useful to enhance device surveillance in young patients. The majority of events were not clinically relevant, and the remaining led to timely management of problems.

Impact of Vice President Cheney on public interest in left ventricular assist devices and heart transplantation.

Science.gov (United States)

Pandey, Ambarish; Abdullah, Kazeen; Drazner, Mark H

2014-05-01

Although celebrity illnesses attract a significant amount of media attention in the United States, there are few studies that have looked at how celebrity health conditions impact the awareness of the illness in the general population. Recently, Vice President Cheney underwent left ventricular assist device (LVAD) implantation and subsequently a cardiac transplant. The aim of this study was to determine whether there was evidence of increased interest in these 2 procedures as assessed by social media. We determined the relative frequency of Google searches for LVAD and heart transplantation from 2004 to 2013 using Google trends. We also counted the number of YouTube videos and Twitter messages posted monthly concerning LVADs over a 7-year time frame. There was a significant spike in the Google search interest for LVAD and heart transplantation in the month when Vice President Cheney underwent the respective procedure. Similarly, there was a large increase in YouTube videos and Twitter messages concerning LVADs shortly after he was implanted. In total, these data support the concept that a public figure's illness can significantly influence the public's interest in that condition and its associated therapies. Copyright © 2014 Elsevier Inc. All rights reserved.

General and acute care surgical procedures in patients with left ventricular assist devices.

Science.gov (United States)

Arnaoutakis, George J; Bittle, Gregory J; Allen, Jeremiah G; Weiss, Eric S; Alejo, Jennifer; Baumgartner, William A; Shah, Ashish S; Wolfgang, Christopher L; Efron, David T; Conte, John V

2014-04-01

Left ventricular assist devices (LVADs) have become common as a bridge to heart transplant as well as destination therapy. Acute care surgical (ACS) problems in this population are prevalent but remain ill-defined. Therefore, we reviewed our experience with ACS interventions in LVAD patients. A total of 173 patients who received HeartMate(®) XVE or HeartMate(®) II (HMII) LVADs between December 2001 and March 2010 were studied. Patient demographics, presentation of ACS problem, operative intervention, co-morbidities, transplantation, complications, and survival were analyzed. A total of 47 (27 %) patients underwent 67 ACS procedures at a median of 38 days after device implant (interquartile range 15-110), with a peri-operative mortality rate of 5 % (N = 3). Demographics, device type, and acuity were comparable between the ACS and non-ACS groups. A total of 21 ACS procedures were performed emergently, eight were urgent, and 38 were elective. Of 29 urgent and emergent procedures, 28 were for abdominal pathology. In eight patients, the cause of the ACS problem was related to LVADs or anticoagulation. Cumulative survival estimates revealed no survival differences if patients underwent ACS procedures (p = 0.17). Among HMII patients, transplantation rates were unaffected by an ACS intervention (p = 0.2). ACS problems occur frequently in LVAD patients and are not associated with adverse outcomes in HMII patients. The acute care surgeon is an integral member of a comprehensive approach to effective LVAD management.

Mycobacterium chimaera left ventricular assist device infections.

Science.gov (United States)

Balsam, Leora B; Louie, Eddie; Hill, Fred; Levine, Jamie; Phillips, Michael S

2017-06-01

A global outbreak of invasive Mycobacterium chimaera infections after cardiac surgery has recently been linked to bioaerosols from contaminated heater-cooler units. The majority of cases have occurred after valvular surgery or aortic graft surgery and nearly half have resulted in death. To date, infections in patients with left ventricular assist devices (LVADs) have not been characterized in the literature. We report two cases of device-associated M. chimaera infection in patients with continuous-flow LVADs and describe challenges related to diagnosis and management in this population. © 2017 Wiley Periodicals, Inc.

Comparison of Transplant Waitlist Outcomes for Pediatric Candidates Supported by Ventricular Assist Devices Versus Medical Therapy.

Science.gov (United States)

Law, Sabrina P; Oron, Assaf P; Kemna, Mariska S; Albers, Erin L; McMullan, D Michael; Chen, Jonathan M; Law, Yuk M

2018-05-01

Ventricular assist devices have gained popularity in the management of refractory heart failure in children listed for heart transplantation. Our primary aim was to compare the composite endpoint of all-cause pretransplant mortality and loss of transplant eligibility in children who were treated with a ventricular assist device versus a medically managed cohort. This was a retrospective cohort analysis. Data were obtained from the Scientific Registry of Transplant Recipients. The at-risk population (n = 1,380) was less than 18 years old, either on a ventricular assist device (605 cases) or an equivalent-severity, intensively medically treated group (referred to as MED, 775 cases). None. The impact of ventricular assist devices was estimated via Cox proportional hazards regression (hazard ratio), dichotomizing 1-year outcomes to "poor" (22%: 193 deaths, 114 too sick) versus all others (940 successful transplants, 41 too healthy, 90 censored), while adjusting for conventional risk factors. Among children 0-12 months old, ventricular assist device was associated with a higher risk of poor outcomes (hazard ratio, 2.1; 95% CI, 1.5-3.0; p comparative study of ventricular assist devices versus medical therapy in children. Age is a significant modulator of waitlist outcomes for children with end-stage heart failure supported by ventricular assist device, with the impact of ventricular assist devices being more beneficial in adolescents.

An ontology-based annotation of cardiac implantable electronic devices to detect therapy changes in a national registry.

Science.gov (United States)

Rosier, Arnaud; Mabo, Philippe; Chauvin, Michel; Burgun, Anita

2015-05-01

The patient population benefitting from cardiac implantable electronic devices (CIEDs) is increasing. This study introduces a device annotation method that supports the consistent description of the functional attributes of cardiac devices and evaluates how this method can detect device changes from a CIED registry. We designed the Cardiac Device Ontology, an ontology of CIEDs and device functions. We annotated 146 cardiac devices with this ontology and used it to detect therapy changes with respect to atrioventricular pacing, cardiac resynchronization therapy, and defibrillation capability in a French national registry of patients with implants (STIDEFIX). We then analyzed a set of 6905 device replacements from the STIDEFIX registry. Ontology-based identification of therapy changes (upgraded, downgraded, or similar) was accurate (6905 cases) and performed better than straightforward analysis of the registry codes (F-measure 1.00 versus 0.75 to 0.97). This study demonstrates the feasibility and effectiveness of ontology-based functional annotation of devices in the cardiac domain. Such annotation allowed a better description and in-depth analysis of STIDEFIX. This method was useful for the automatic detection of therapy changes and may be reused for analyzing data from other device registries.

[An implantable micro-device using wireless power transmission for measuring aortic aneurysm sac pressure].

Science.gov (United States)

Guo, Xudong; Ge, Bin; Wang, Wenxing

2013-08-01

In order to detect endoleaks after endovascular aneurysm repair (EVAR), we developed an implantable micro-device based on wireless power transmission to measure aortic aneurysm sac pressure. The implantable micro-device is composed of a miniature wireless pressure sensor, an energy transmitting coil, a data recorder and a data processing platform. Power transmission without interconnecting wires is performed by a transmitting coil and a receiving coil. The coupling efficiency of wireless power transmission depends on the coupling coefficient between the transmitting coil and the receiving coil. With theoretical analysis and experimental study, we optimized the geometry of the receiving coil to increase the coupling coefficient. In order to keep efficiency balance and satisfy the maximizing conditions, we designed a closed loop power transmission circuit, including a receiving voltage feedback module based on wireless communication. The closed loop improved the stability and reliability of transmission energy. The prototype of the micro-device has been developed and the experiment has been performed. The experiments showed that the micro-device was feasible and valid. For normal operation, the distance between the transmitting coil and the receiving coil is smaller than 8cm. Besides, the distance between the micro-device and the data recorder is within 50cm.

Ethical Analysis of Withdrawing Ventricular Assist Device Support

OpenAIRE

Mueller, Paul S.; Swetz, Keith M.; Freeman, Monica R.; Carter, Kari A.; Crowley, Mary Eliot; Severson, Cathy J. Anderson; Park, Soon J.; Sulmasy, Daniel P.

2010-01-01

OBJECTIVE: To describe a series of patients with heart failure supported with a ventricular assist device (VAD) who requested (or whose surrogates requested) withdrawal of VAD support and the legal and ethical aspects pertaining to these requests.

Pacemaker Use in New Zealand - Data From the New Zealand Implanted Cardiac Device Registry (ANZACS-QI 15).

Science.gov (United States)

Larsen, P D; Kerr, A J; Hood, M; Harding, S A; Hooks, D; Heaven, D; Lever, N A; Sinclair, S; Boddington, D; Tang, E W; Swampillai, J; Stiles, M K

2017-03-01

The New Zealand Cardiac Implanted Device Registry (Device) has recently been developed under the auspices of the New Zealand Branch of the Cardiac Society of Australia and New Zealand. This study describes the initial Device registry cohort of patients receiving a new pacemaker, their indications for pacing and their perioperative complications. The Device Registry was used to audit patients receiving a first pacemaker between 1 st January 2014 and 1 st June 2015. We examined 1611 patients undergoing first pacemaker implantation. Patients were predominantly male (59%), and had a median age of 70 years. The most common symptom for pacemaker implantation was syncope (39%), followed by dizziness (30%) and dyspnoea (12%). The most common aetiology for a pacemaker was a conduction tissue disorder (35%), followed by sinus node dysfunction (22%). Atrioventricular (AV) block was the most common ECG abnormality, present in 44%. Dual chamber pacemakers were most common (62%), followed by single chamber ventricular pacemakers (34%), and cardiac resynchronisation therapy - pacemakers (CRT-P) (2%). Complications within 24hours of the implant procedure were reported in 64 patients (3.9%), none of which were fatal. The most common complication was the need for reoperation to manipulate a lead, occurring in 23 patients (1.4%). This is the first description of data entered into the Device registry. Patients receiving a pacemaker were younger than in European registries, and there was a low use of CRT-P devices compared to international rates. Complications rates were low and compare favourably to available international data. Copyright © 2016 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). Published by Elsevier B.V. All rights reserved.

Exertional Angina Due To Fused Aortic Bioprosthesis During Left Ventricular Assist Device Support: Two Cases and Review of the Literature.

Science.gov (United States)

Bonios, Michael J; Selzman, Craig H; Gilbert, Edward M; McKellar, Stephen H; Koliopoulou, Antigoni; Strege, Jennifer L; Nativi, Jose N; Fang, James C; Stehlik, Josef; Drakos, Stavros G

We present the case of two patients with idiopathic dilated cardiomyopathy and moderate aortic valve regurgitation that were treated with a bioprosthetic valve at the time of the left ventricular assist device (LVAD) implantation. A few months later, patients revealed partial recovery in the left ventricle systolic function. Both patients, during the LVAD turndown protocol, reported the onset of chest pain. The transthoracic echocardiography revealed the presence of a new transaortic pressure gradient. We confirmed the presence of a fused bioprosthetic valve by further performing a transesophageal echocardiogram and a left and right heart catheterization. Replacement of aortic valve at the time of an LVAD implantation constitutes a challenging case. Although a mechanical valve is contraindicated due to the increased thromboembolic risk, selecting a bioprosthetic valve increases the risk of valve leaflets fusion. The consequences of this phenomenon should be acknowledged in LVAD patients undergoing aortic valve replacement with a bioprosthetic, especially under the view of LVAD explantation for those revealing myocardial recovery under mechanical unloading.

Active implantable medical device EMI assessment for wireless power transfer operating in LF and HF bands.

Science.gov (United States)

Hikage, Takashi; Nojima, Toshio; Fujimoto, Hiroshi

2016-06-21

The electromagnetic interference (EMI) imposed on active implantable medical devices by wireless power transfer systems (WPTSs) is discussed based upon results of in vitro experiments. The purpose of this study is to present comprehensive EMI test results gathered from implantable-cardiac pacemakers and implantable cardioverter defibrillators exposed to the electromagnetic field generated by several WPTSs operating in low-frequency (70 kHz-460 kHz) and high-frequency (6.78 MHz) bands. The constructed in vitro experimental test system based upon an Irnich's flat torso phantom was applied. EMI test experiments are conducted on 14 types of WPTSs including Qi-compliant system and EV-charging WPT system mounted on current production EVs. In addition, a numerical simulation model for active implantable medical device (AIMD) EMI estimation based on the experimental test system is newly proposed. The experimental results demonstrate the risk of WPTSs emitting intermittent signal to affect the correct behavior of AIMDs when operating at very short distances. The proposed numerical simulation model is applicable to obtain basically the EMI characteristics of various types of WPTSs.

Surface modification technique of structural ceramics: ion implantation-assisted multi-arc ion plating

International Nuclear Information System (INIS)

Peng Zhijian; Miao Hezhuo; Si Wenjie; Qi Longhao; Li Wenzhi

2003-01-01

Through reviewing the advantages and disadvantages of the existed surface modification techniques, a new technique, ion implantation-assisted multi-arc ion plating, was proposed. Using the proposed technique, the surfaces of silicon nitride ceramics were modified by Ti ion implantation, and then three kinds of ternary coatings, (Ti,Al)N, (Ti,Zr)N and (Ti,Cr)N, were deposited on the as-implanted ceramics. The coatings prepared by this technique are of high-hardness and well adhesive to the ceramic substrates. The maximal hardness measured by nanoindentation tests is more than 40 GPa. The maximal critical load by nanoscratch tests is more than 60 mN. The cutting tools prepared by this technique with the presented coatings are of excellent performance in industrial applications. The technique may be promising for the surface modification of structural ceramics. (orig.)

Benefit of a Contralateral Routing of Signal Device for Unilateral Cochlear Implant Users.

OpenAIRE

Weder, Stefan; Kompis, Martin; Caversaccio, Marco; Stieger, Christof

2014-01-01

Objective: To investigate objective and subjective effects of an adjunctive contralateral routing of signal (CROS) device at the untreated ear in patients with a unilateral cochlear implant (CI). Design: Prospective study of 10 adult experienced unilateral CI users with bilateral severe-to-profound hearing loss. Speech in noise reception (SNR) and sound localization were measured with and without the additional CROS device. SNR was measured by applying speech signals at the untreated/CROS sid...

Implanted cardiac devices are reliably detected by commercially available metal detectors

DEFF Research Database (Denmark)

Holm, Katja Fiedler; Hjortshøj, Søren Pihlkjær; Pehrson, Steen

2013-01-01

Explosions of Cardiovascular Implantable Electronic Devices (CIEDs) (pacemakers, defibrillators, and loop recorders) are a well-recognized problem during cremation, due to lithium-iodine batteries. In addition, burial of the deceased with a CIED can present a potential risk for environmental...... contamination. Therefore, detection of CIEDs in the deceased would be of value. This study evaluated a commercially available metal detector for detecting CIEDs....

Right ventricular dysfunction following continuous flow left ventriccular assist device placement in 51 patients: predicators and outcomes

Directory of Open Access Journals (Sweden)

Neragi-Miandoab Siyamek

2012-06-01

Full Text Available Abstract Background Right ventricular (RV dysfunction following implantation of a left ventricular assist device (LVAD is a serious condition and is associated with increased mortality. Methods The aim of the study is to investigate the significance of pre-existing RV dysfunction, tricuspid valve (TV insufficiency, and the severity of septal deviation following LVAD implantation on RV dysfunction, as well as the outcome and short-term complications in 51 patients from June 2006 to August 2010. Student t test was used to compare the data and estimate the p value. Results Mean age was 55.1 ± 13, with a male to female ratio of 3.25. The 30-day mortality was 13.7% (7/51 patients, and the overall mortality was 23.5% (12/51 patients. Meanwhile, 21 patients (21/51; 41.2% have undergone orthotopic heart transplantation. The mean time of support was 314.5±235 days with a median of 240 days at the time of closing this study. Echocardiographic evaluation of RV function pre- and post-implantation of an LVAD demonstrated septal deviation towards the left ventricle in immediate postoperative phase, which correlated with acute RV dysfunction (p = 0.002. Preoperative RV dysfunction was a significant predictor of postoperative right heart dysfunction following implantation of an LVAD (p = 0.001. Conclusion Preoperative RV dysfunction is a predictor of RV failure in LVAD patients. The adjustment of septal deviation through gradual increase of the LVAD flow can prevent the acute RV dysfunction following LVAD placement.

Exercise guidelines for inpatients following ventricular assist device placement: a systematic review of the literature.

Science.gov (United States)

Scheiderer, Rachel; Belden, Courtney; Schwab, Darla; Haney, Casey; Paz, Jaime

2013-06-01

For patients with end-stage heart failure awaiting transplantation, lack of donor organs has created an increased need for alternatives such as left ventricular assist device (LVAD) implantation. The purpose of this study is to determine safe and effective exercise parameters for physical therapy in the acute care setting. A systematic literature review was conducted according to PRISMA guidelines using Sackett's Levels of Evidence to rate the evidence. Multiple databases were searched with inclusion criteria of: available in English, inpatient care up to 6 months postoperatively, description of intervention type and exercise parameters. no defined exercise parameters, outpatient treatment, infection post VAD, or palliative or hospice care post VAD. Six studies out of 1,291 articles met inclusion criteria. Common exercise parameters used were the Borg Rating of Perceived Exertion scale 11-13 (6-20 scale) or > 4 (0-10 scale), Dyspnea scale > 2 (0-4 scale) and > 5 (0-10 scale), mean arterial pressure (MAP) 70-95 mmHg, and LVAD flow > 3L/min. Levels of evidence ranged from case controlled to expert opinion. Current evidence on inpatient exercise parameters for patient's status post LVAD implantation is not sufficient to suggest definitive guidelines; however, these exercise parameters provide a reference for patient care.

The Use of Lithium Batteries in Biomedical Devices

Science.gov (United States)

1989-06-15

bone growth stimulator (12) implantable sensor (6) drug infusion system (13) neurostimulator (7) gait assist device (14) pain suppressor The preferred...1000-2000 defibrillator 10-80 2000 neurostimulator 10-20 1-5 drug pump 20-50 1-2 tachyarrythmia control 20-100 2 dual cliamber paceinaker 20-100 single

De novo aortic insufficiency during long-term support on a left ventricular assist device: a systematic review and meta-analysis.

Science.gov (United States)

Deo, Salil V; Sharma, Vikas; Cho, Yang Hyun; Shah, Ishan K; Park, Soon J

2014-01-01

Aortic insufficiency (AI) may occur while supported on a left ventricular assist device (LVAD). We conducted a systematic review to determine the incidence, predictors, and consequences of AI during LVAD support. MEDLINE was searched for original studies presenting clinical data regarding patients who developed AI during LVAD implant. Seven observational studies (657 patients) were selected for review; 65% of patients underwent implantation with a continuous-flow device (Cf-LVAD). The incidence of AI was 25% (11-42%) (Support period: 412 ± 281 days). AI increased by 4% (1-6%) per month of support (p < 0.01). AI-positive patients were older at implant (weighted mean difference, 7.7 [4.3; 11.1]; p < 0.01). Female sex (0.002 ± 0.001; p = 0.01) and smaller body surface area (-0.003 ± 0.001 per m; p < 0.01) correlated with progressive AI. Destination therapy patients (odds ratio [OR], 5.3 [1.2, 24]; p = 0.02) and those with Cf-LVAD pumps were likely to develop AI (hazard ratio [HR], 2.2 [1.2, 3.8]; p < 0.01). A closed aortic valve was associated with AI (OR, 4.7 [1.9, 11.8]; p < 0.01). Survival was comparable in both cohorts (HR, 1.5 [0.81, 2.8]; p = 0.2). A significant number of patients develop de novo AI during LVAD support. Advanced age, longer support duration, continuous-flow pumps, and a closed aortic valve are associated with AI. Large cohort studies would improve our understanding of this condition.

Intra-aneurysmal flow disruption after implantation of the Medina® Embolization Device depends on aneurysm neck coverage.

Science.gov (United States)

Frölich, Andreas Maximilian; Nawka, Marie Teresa; Ernst, Marielle; Frischmuth, Isabell; Fiehler, Jens; Buhk, Jan-Hendrik

2018-01-01

Flow disruption achieved by braided intrasaccular implants is a novel treatment strategy for cerebrovascular aneurysms. We hypothesized that the degree of intra-aneurysmal flow disruption can be quantified in vitro and is influenced by device position across the aneurysm neck. We tested this hypothesis using the Medina® Embolization Device (MED). Ten different patient-specific elastic vascular models were manufactured. Models were connected to a pulsatile flow circuit, filled with a blood-mimicking fluid and treated by two operators using a single MED. Intra-aneurysmal flow velocity was measured using conventional and high-frequency digital subtraction angiography (HF-DSA) before and after each deployment. Aneurysm neck coverage by the implanted devices was assessed with flat detector computed tomography on a three-point Likert scale. A total of 80 individual MED deployments were performed by the two operators. The mean intra-aneurysmal flow velocity reduction after MED implantation was 33.6% (27.5-39.7%). No significant differences in neck coverage (p = 0.99) or flow disruption (p = 0.84) were observed between operators. The degree of flow disruption significantly correlated with neck coverage (ρ = 0.42, 95% CI: 0.21-0.59, p = 0.002) as well as with neck area (ρ = -0,35, 95% CI: -0.54 --0.13, p = 0.024). On multiple regression analysis, both neck coverage and total neck area were independent predictors of flow disruption. The degree of intra-aneurysmal flow disruption after MED implantation can be quantified in vitro and varies considerably between different aneurysms and different device configurations. Optimal device coverage across the aneurysm neck improves flow disruption and may thus contribute to aneurysm occlusion.

In-situ photopolymerization and monitoring device for controlled shaping of tissue fillers, replacements, or implants

Science.gov (United States)

Schmocker, Andreas M.; Khoushabi, Azadeh; Bourban, Pierre-Etienne; Schizas, Constantin; Pioletti, Dominique; Moser, Christophe

2015-03-01

Photopolymerization is a common tool to harden materials initially in a liquid state. A surgeon can directly trigger the solidification of a dental implant or a bone or tissue filler simply by illumination. Traditionally, photopolymerization has been used mainly in dentistry. Over the last decade advances in material development including a wide range of biocompatible gel- and cement-systems open up a new avenue for in-situ photopolymerization. However, at the device level, surgical endoscopic probes are required. We present a miniaturized light probe where a photoactive material can be 1) mixed, pressurized and injected 2) photopolymerized or photoactivated and 3) monitored during the chemical reaction. The device enables surgeries to be conducted through a hole smaller than 1 mm in diameter. Beside basic injection mechanics, the tool consists of an optical fiber guiding the light required for photopolymerization and for chemical analysis. Combining photorheology and fluorescence spectroscopy, the current state of the photopolymerization is inferred and monitored in real time. Biocompatible and highly tuneable Poly-Ethylene-Glycol (PEG) hydrogels were used as the injection material. The device was tested on a model for intervertebral disc replacement. Gels were successfully implanted into a bovine caudal model and mechanically tested in-vitro during two weeks. The photopolymerized gel was evaluated at the tissue level (adherence and mechanical properties of the implant), at the cellular level (biocompatibility and cytotoxicity) and ergonomic level (sterilization procedure and feasibility study). This paper covers the monitoring aspect of the device.

Assistive device use and mobility-related factors among adults aged≥65years.

Science.gov (United States)

West, Bethany A; Bhat, Geeta; Stevens, Judy; Bergen, Gwen

2015-12-01

Examining how assistive device (cane, walker) use relates to other mobility factors can provide insight into older adults' future mobility needs. Data come from the Second Injury Control and Risk Survey, Phase 2 (ICARIS2-P2), conducted from March 2007 to May 2008. Prevalence estimates were calculated for older adults (aged ≥65) and multivariable logistic regression was used to explore associations between assistive device use and mobility-related characteristics. Compared with non-users, assistive device users were more likely to report a recent fall (AOR 12.0; 95% CI 4.9-29.3), limit walking outside due to concerns about falling (AOR 7.1; 95% CI 2.6-19.1), be unable to walk outside for 10min without resting (AOR 3.3; 95% CI 1.1-9.3), and be no longer driving (AOR 6.7; 95% CI 2.0-22.3). Assistive device users have limited mobility and an increased risk for fall injury compared with non-users. Effective fall prevention interventions, and innovative transportation options, are needed to protect the mobility of this high-risk group. Published by Elsevier Ltd.

Implantation of a cardiac resynchronization therapy-defibrillator device in a patient with persistent left superior vena cava.

Science.gov (United States)

Atar, İlyas; Karaçağlar, Emir; Özçalık, Emre; Özin, Bülent; Müderrisoğlu, Haldun

2015-06-01

Presence of a persistent left superior vena cava (PLSVC) is generally clinically asymptomatic and discovered incidentally during central venous catheterization. However, PLSVC may cause technical difficulties during cardiac device implantation. An 82-year-old man with heart failure symptoms and an ejection fraction (EF) of 20% was scheduled for resynchronization therapy-defibrillator device (CRT-D) implantation. A PLSVC draining via a dilated coronary sinus into an enlarged right atrium was diagnosed. First, an active-fixation right ventricular lead was inserted into the right atrium through the PLSVC. The stylet was preshaped to facilitate its passage to the right ventricular apex. An atrial lead was positioned on the right atrium free wall, and an over-the-wire coronary sinus lead deployed to a stable position. CRT-D implantation procedure was successfully completed.

In vivo delivery of recombinant human growth hormone from genetically engineered human fibroblasts implanted within Baxter immunoisolation devices.

Science.gov (United States)

Josephs, S F; Loudovaris, T; Dixit, A; Young, S K; Johnson, R C

1999-01-01

Continuous delivery of therapeutic peptide to the systemic circulation would be the optimal treatment for a variety of diseases. The Baxter TheraCyte system is a membrane encapsulation system developed for implantation of tissues, cells such as endocrine cells or cell lines genetically engineered for therapeutic peptide delivery in vivo. To demonstrate the utility of this system, cell lines were developed which expressed human growth hormone (hGH) at levels exceeding 1 microgram per million cells per day. These were loaded into devices which were then implanted into juvenile nude rats. Significant levels of hGH of up to 2.5 ng/ml were detected in plasma throughout the six month duration of the study. In contrast, animals implanted with free cells showed peak plasma levels of 0.5 to 1.2 ng four days after implantation with no detectable hGH beyond 10 days. Histological examination of explanted devices showed they were vascularized and contained cells that were viable and morphologically healthy. After removal of the implants, no hGH could be detected which confirmed that the source of hGH was from cells contained within the device. The long term expression of human growth hormone as a model peptide has implications for the peptide therapies for a variety of human diseases using membrane encapsulated cells.

Multicentre prospective evaluation of implant-assisted mandibular bilateral distal extension removable partial dentures: patient satisfaction

NARCIS (Netherlands)

Wismeijer, D.; Tawse-Smith, A.; Payne, A.G.T.

2013-01-01

Objective To compare the levels of patient satisfaction with either conventional mandibular bilateral distal extension partial dentures or those assisted by bilateral distal implants. Materials and methods Forty-eight participants who were dissatisfied with their existing conventional mandibular

Wireless energy transfer platform for medical sensors and implantable devices.

Science.gov (United States)

Zhang, Fei; Hackworth, Steven A; Liu, Xiaoyu; Chen, Haiyan; Sclabassi, Robert J; Sun, Mingui

2009-01-01

Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro experiments, both in open air and using a human head phantom consisting of simulated tissues, are employed to verify the feasibility of this platform. An animal model is utilized to evaluate in vivo energy transfer within the body of a laboratory pig. Our experiments indicate that witricity is an effective new tool for providing a variety of medical sensors and devices with power.

Electromagnetic Interference in Patients with Implanted Cardioverter-Defibrillators and Implantable Loop Recorders

Directory of Open Access Journals (Sweden)

Marcos de Sousa

2002-07-01

Full Text Available Modern life exposes us all to an ever-increasing number of potential sources of electromagnetic interference (EMI and patients with Implantable rhythm devices (IRD like pacemakers, implantable cardioverter defibrillators or implantable loop recorders often ask about the use of microwave ovens, walking through airport metal detectors and the use of cellular phones. Electromagnetic interference occurs when electromagnetic waves emitted by one device impede the normal function of another electronic device. The potential for interaction between implanted pacing systems and cardioverter-defibrillators (electromagnetic interference, EMI has been recognized for years.1,2,3,4. It has been shown that EMI can produce clinically significant effects on patients with implanted pacemakers and ICDs. For these reasons the following text discusses the influence of several EMI generating devices on IRD .

Development of Hand Grip Assistive Device Control System for Old People through Electromyography (EMG) Signal Acquisitions

OpenAIRE

Khamis Herman; Mohamaddan Shahrol; Komeda Takashi; Alias Aidil Azli; Tanjong Shirley Jonathan; Julai Norhuzaimin; Hashim Nurul ‘Izzati

2017-01-01

The hand grip assistive device is a glove to assist old people who suffer from hand weakness in their daily life activities. The device earlier control system only use simple on and off switch. This required old people to use both hand to activate the device. The new control system of the hand grip assistive device was developed to allow single hand operation for old people. New control system take advantages of electromyography (EMG) and flex sensor which was implemented to the device. It wa...

Continuous flow left ventricular assist devices: shared care goals of monitoring and treating patients.

Science.gov (United States)

Estep, Jerry D; Trachtenberg, Barry H; Loza, Laurie P; Bruckner, Brian A

2015-01-01

Continuous-flow left ventricular assist devices (CF-LVADs) have been clinically adopted as a long-term standard of care therapy option for patients with end-stage heart failure. For many patients, shared care between the care providers at the implanting center and care providers in the community in which the patient resides is a clinical necessity. The aims of this review are to (1) provide a rationale for the outpatient follow-up exam and surveillance testing used at our center to monitor patients supported by the HeartMate II(®) CF-LVAD (Thoratec Corporation, Pleasanton, CA) and (2) provide the protocol/algorithms we use for blood pressure, driveline exit site, LVAD alarm history, surveillance blood work, and echocardiography monitoring in this patient population. In addition, we define our partnership outpatient follow-up protocol and the "shared care" specific responsibilities we use with referring health care providers to best manage many of our patients.

Cardiac transplantation after bridged therapy with continuous flow left ventricular assist devices.

Science.gov (United States)

Deo, Salil V; Sung, Kiick; Daly, Richard C; Shah, Ishan K; Altarabsheh, Salah E; Stulak, John M; Joyce, Lyle D; Boilson, Barry A; Kushwaha, Sudhir S; Park, Soon J

2014-03-01

Cardiac transplantation is an effective surgical therapy for end-stage heart failure. Patients (pts) may need to be bridged with a continuous flow left ventricular assist device (CF-LVAD) while on the transplant list as logistic factors like organ availability are unknown. Cardiac transplantation post-LVAD can be a surgically challenging procedure and outcome in these pts is perceived to be poorer based on experience with earlier generation pulsatile flow pumps. Data from a single institution comparing these pts with those undergoing direct transplantation in the present era of continuous flow device therapy are limited. Evaluate results of cardiac transplantation in pts bridged with a CF-LVAD (BTx) and compare outcomes with pts undergoing direct transplantation (Tx) in a single institution. From June 2007 till January 2012, 106 pts underwent cardiac transplantation. Among these, 37 (35%) pts (51±11 years; 85% male) were bridged with a CF-LVAD (BTx), while 70 (65%) comprised the Tx group (53±12 years; 72% males). The median duration of LVAD support was 227 (153,327) days. During the period of LVAD support, 10/37 (27%) pts were upgraded to status 1A and all were successfully transplanted. Median hospital stay in the BTx (14 days) was slightly longer than the Tx group (12 days) but not statistically significant (p=0.21). In-hospital mortality in the BTx (5%) and Tx (1%) were comparable (p=0.25). Estimated late survival in the BTx cohort was 94±7, 90±10 and 83±16% at the end of one, two and three years, respectively which was comparable to 97±4%, 93±6% and 89±9% for the Tx group (p=0.50). Cardiac transplantation after LVAD implant can be performed with excellent results. Patients can be supported on the left ventricular assist device even for periods close to a year with good outcome after cardiac transplantation. Copyright © 2013 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand

Left ventricular assist device (lvad design features: literature review

Directory of Open Access Journals (Sweden)

Yu. V. Bogdanova

2014-01-01

Full Text Available More than 8 million people in our country suffer from heart failure. About one million of these people die each year [1]. The problem of ventricular assist device creating - a mechanical device used for partial or complete replacement of heart function - is investigated for a long time (according to [2] just in our country since the 1970s. Today plenty of encouraging results are received. There is a number of VAD models which are successfully applied to patients with heart failure. After implantation, patients conduct a way of life that is normal in many respects: they are in the family, often they have an opportunity to work in their former specialty. Some of them live with the device about 8 years [3].According to [4] for 2010 the estimated total number of long-term devices implanted in the United States per year is over 1,700 (the population of the U.S. is 305 million, compared with over 430 per year in Europe (the population of Europe is 731 million. Unfortunately, people who need a heart transplant are much more.The principle of VAD is that being connected to the left ventricle with one cannula and to the ascending aorta with the other cannula the pump fully or partially replaces the function of the natural heart. This scheme allows the use of VAD in two ways: as a "bridge to transplantation" when the device is used temporarily until the donor heart is found, and a "bridge to recovery", when through the use of VAD the function of the heart muscle is recovered.VAD system can be divided into three subsystems: blood pump, power supply system and control system (Fig. 1.Each subsystem can be the subject of separate study. Special role in the development of VAD plays medical side of the issue. Successful research and development require interaction with qualified professionals in this field. The development of VAD is a multidisciplinary problem which demands fulfilment of a number of requirements.One of the most active programs in implantation of

Ion implantation

International Nuclear Information System (INIS)

Dearnaley, Geoffrey

1975-01-01

First, ion implantation in semiconductors is discussed: ion penetration, annealing of damage, gettering, ion implanted semiconductor devices, equipement requirements for ion implantation. The importance of channeling for ion implantation is studied. Then, some applications of ion implantation in metals are presented: study of the corrosion of metals and alloys; influence or ion implantation on the surface-friction and wear properties of metals; hyperfine interactions in implanted metals

Perioperative Interrogation of St. Jude Cardiovascular Implantable Electronic Devices: A Guide for Anesthesiologists.

Science.gov (United States)

Cronin, Brett; Essandoh, Michael K

2018-04-01

Feelings of trepidation or uncertainty regarding cardiovascular implantable electronic devices (CIEDs) in the perioperative period can often be mitigated by a thorough knowledge of societal recommendations, recommended management options, and familiarity with CIEDs. Given that effective interpretation of an interrogation report is vital to determining perioperative management options and applying societal recommendations, the creation and interpretation of St. Jude CIED interrogation reports are discussed. In an effort to increase the familiarity with St. Jude transvenous CIEDs amongst anesthesiologists, basic programming of a St. Jude pacemaker and implantable cardioverter defibrillator (ICD) also are described. Published by Elsevier Inc.

Development of high impedance measurement system for water leakage detection in implantable neuroprosthetic devices.

Science.gov (United States)

Yousif, Aziz; Kelly, Shawn K

2016-08-01

There has been a push for a greater number of channels in implantable neuroprosthetic devices; but, that number has largely been limited by current hermetic packaging technology. Microfabricated packaging is becoming reality, but a standard testing system is needed to prepare these devices for clinical trials. Impedance measurements of electrodes built into the packaging layers may give an early warning of device failure and predict device lifetime. Because the impedance magnitudes of such devices can be on the order of gigaohms, a versatile system was designed to accommodate ultra-high impedances and allow future integrated circuit implementation in current neural prosthetic technologies. Here we present the circuitry, control software, and preliminary testing results of our designed system.

Columnar transmitter based wireless power delivery system for implantable device in freely moving animals.

Science.gov (United States)

Eom, Kyungsik; Jeong, Joonsoo; Lee, Tae Hyung; Lee, Sung Eun; Jun, Sang Bum; Kim, Sung June

2013-01-01

A wireless power delivery system is developed to deliver electrical power to the neuroprosthetic devices that are implanted into animals freely moving inside the cage. The wireless powering cage is designed for long-term animal experiments without cumbersome wires for power supply or the replacement of batteries. In the present study, we propose a novel wireless power transmission system using resonator-based inductive links to increase power efficiency and to minimize the efficiency variations. A columnar transmitter coil is proposed to provide lateral uniformity of power efficiency. Using this columnar transmitter coil, only 7.2% efficiency fluctuation occurs from the maximum transmission efficiency of 25.9%. A flexible polymer-based planar type receiver coil is fabricated and assembled with a neural stimulator and an electrode. Using the designed columnar transmitter coil, the implantable device successfully operates while it moves freely inside the cage.

Telemetry and Telestimulation via Implanted Devices Necessary in Long-Term Experiments Using Conscious Untethered Animals for the Development of New Medical Treatments

Science.gov (United States)

Sugimachi, Masaru; Kawada, Toru; Uemura, Kazunori

Effective countermeasures against explosive increase in healthcare expenditures are urgently needed. A paradigm shift in healthcare is called for, and academics and governments worldwide are working hard on the application of information and communication technologies (ICT) as a feasible and effective measure for reducing medical cost. The more prevalent the disease and the easier disease outcome can be improved, the more efficient is medical ICT in reducing healthcare cost. Hypertension and diabetes mellitus are such examples. Chronic heart failure is another disease in which patients may benefit from ICT-based medical practice. It is conceivable that daily monitoring of hemodynamics together with appropriate treatments may obviate the expensive hospitalization. ICT potentially permit continuous monitoring with wearable or implantable medical devices. ICT may also help accelerate the development of new therapeutic devices. Traditionally effectiveness of treatments is sequentially examined by sacrificing a number of animals at a given time point. These inefficient and inaccurate methods can be replaced by applying ICT to the devices used in chronic animal experiments. These devices allow researchers to obtain biosignals and images from live animals without killing them. They include implantable telemetric devices, implantable telestimulation devices, and imaging devices. Implanted rather than wired monitoring and stimulation devices permit experiments to be conducted under even more physiological conditions, i.e., untethered, free-moving states. Wireless communication and ICT are indispensible technologies for the development of such telemetric and telestimulation devices.

Design and simulation of printed spiral coil used in wireless power transmission systems for implant medical devices.

Science.gov (United States)

Wu, Wei; Fang, Qiang

2011-01-01

Printed Spiral Coil (PSC) is a coil antenna for near-field wireless power transmission to the next generation implant medical devices. PSC for implant medical device should be power efficient and low electromagnetic radiation to human tissues. We utilized a physical model of printed spiral coil and applied our algorithm to design PSC operating at 13.56 MHz. Numerical and electromagnetic simulation of power transfer efficiency of PSC in air medium is 77.5% and 71.1%, respectively. The simulation results show that the printed spiral coil which is optimized for air will keep 15.2% power transfer efficiency in human subcutaneous tissues. In addition, the Specific Absorption Ratio (SAR) for this coil antenna in subcutaneous at 13.56 MHz is below 1.6 W/Kg, which suggests this coil is implantable safe based on IEEE C95.1 safety guideline.

Network-Assisted Device-to-Device (D2D) Direct Proximity Discovery with Underlay Communication

DEFF Research Database (Denmark)

Pratas, Nuno; Popovski, Petar

2015-01-01

) direct communication between proximate devices. While (ii) is treated extensively in the recent literature, (i) has received relatively little attention. In this paper we analyze a network-assisted underlay proximity discovery protocol, where a cellular device can take the role of: announcer (which......Device-to-Device communications are expected to play an important role in current and future cellular generations, by increasing the spatial reuse of spectrum resources and enabling lower latency communication links. This paradigm has two fundamental building blocks: (i) proximity discovery and (ii......, we consider the case where the announcers underlay their messages in the downlink transmissions that are directed towards the monitoring devices. We propose a power control scheme applied to the downlink transmission, which copes with the underlay transmission via additional power expenditure, while...

Dosimetry verification of radioactive seed implantation for malignant tumors assisted by 3D printing individual templates and CT guidance

International Nuclear Information System (INIS)

Ji, Zhe; Jiang, Yuliang; Guo, Fuxin; Sun, Haitao; Fan, Jinghong; Zhang, Lujing; Wang, Junjie

2017-01-01

Objective: We compared the dose distributions of postoperative plans with preoperative plans for 3D printing template-assisted radioactive seed implantations. Methods: A total of 14 patients with malignant tumors enrolled in the study. The dose parameters included D90, minimum peripheral dose, V100, V150, and V200. The statistical method was the paired t-test. Results: There was no significant difference in P values between the two groups for all parameters except for V100. Conclusions: The 3D printing guide template can provide good accuracy for radioactive seed implantation. - Highlights: • It is the first study we as for as we know to compare the preoperative and postoperative dosimetry results of 3D printing templates-assisted radioactive seeds implantation for malignant tumor. • 3D printing guide template can provide good accuracy for radioactive seeds implantation. • The actual dose distributions in postoperative validations were closed to the expectations of preoperative plans. • 3D printing template providing us an effective tool for the standardization and normalization of seed implantation, and having a good application prospect and worthy of further development and popularization.

A cardiac implantable device infection by Raoultella planticola in an immunocompromized patient.

Science.gov (United States)

Adjodah, Chandra; D'Ivernois, Chistophe; Leyssene, David; Berneau, Jean-Baptiste; Hemery, Yann

2017-02-01

Introduction. Infection of cardiac implantable electronic devices is a severe condition associated with high mortality, particularly in patients who are dependent upon heart-pacing devices. Staphylococci are found in 70 % of reported cases. Case presentation. We report the case of a cardiac-pacemaker infection in a 79-year-old man, cumulating a history of rheumatoid arthritis treated by corticosteroids and methotrexate by a recently identified micro-organism: Raoultella planticola . He presented local signs of infection on his VVI pacemaker implantation site and underwent urgent pocket device replacement under cefamandole antibioprophylaxis. On incision thick pus oozed out. It was necessary to perform a complete hardware extraction comprising the pulse generator and the ancient lead. Pus was inoculated into aerobic and anaerobic culture vials and Gram staining unveiled Gram-negative rods. Microbiology analysis identified the organism as R. planticola. A new pacing device was inserted on the contrlateral pectoral region. Ciprofloxacin enabled full recovery. A literature review concerning this pathogen revealed that it is involved in severe infections such as bloodstream infections, peritonitis, cellulitis, pneumonia and lung abscesses, and urinary tract infections. In these case reports, underlying co-morbidities were identified such as solid active neoplasia, recent chemotherapy, corticosteroids, solid-organ-recipient patients and recent open surgery. Conclusion. R. planticola is a serious emerging pathogen and contributes to the burden of various infectious conditions. Its pathogenicity and occurrence should be known by clinicians and a high level of awareness is necessary to precisely identify it provide the correct antibiotic regimen.

Fully digital data processing during cardiovascular implantable electronic device follow-up in a high-volume tertiary center.

Science.gov (United States)

Staudacher, Ingo; Nalpathamkalam, Asha Roy; Uhlmann, Lorenz; Illg, Claudius; Seehausen, Sebastian; Akhavanpoor, Mohammadreza; Buchauer, Anke; Geis, Nicolas; Lugenbiel, Patrick; Schweizer, Patrick A; Xynogalos, Panagiotis; Zylla, Maura M; Scholz, Eberhard; Zitron, Edgar; Katus, Hugo A; Thomas, Dierk

2017-10-11

Increasing numbers of patients with cardiovascular implantable electronic devices (CIEDs) and limited follow-up capacities highlight unmet challenges in clinical electrophysiology. Integrated software (MediConnect ® ) enabling fully digital processing of device interrogation data has been commercially developed to facilitate follow-up visits. We sought to assess feasibility of fully digital data processing (FDDP) during ambulatory device follow-up in a high-volume tertiary hospital to provide guidance for future users of FDDP software. A total of 391 patients (mean age, 70 years) presenting to the outpatient department for routine device follow-up were analyzed (pacemaker, 44%; implantable cardioverter defibrillator, 39%; cardiac resynchronization therapy device, 16%). Quality of data transfer and follow-up duration were compared between digital (n = 265) and manual processing of device data (n = 126). Digital data import was successful, complete and correct in 82% of cases when early software versions were used. When using the most recent software version the rate of successful digital data import increased to 100%. Software-based import of interrogation data was complete and without failure in 97% of cases. The mean duration of a follow-up visit did not differ between the two groups (digital 18.7 min vs. manual data transfer 18.2 min). FDDP software was successfully implemented into the ambulatory follow-up of patients with implanted pacemakers and defibrillators. Digital data import into electronic patient management software was feasible and supported the physician's workflow. The total duration of follow-up visits comprising technical device interrogation and clinical actions was not affected in the present tertiary center outpatient cohort.

First-in-man use of a novel embolic protection device for patients undergoing transcatheter aortic valve implantation.

Science.gov (United States)

Naber, Christoph K; Ghanem, Alexander; Abizaid, Alexander A; Wolf, Alexander; Sinning, Jan-Malte; Werner, Nikos; Nickenig, Georg; Schmitz, Thomas; Grube, Eberhard

2012-05-15

We describe the first-in-human experience with a novel cerebral embolic protection device used during transcatheter aortic valve implantation (TAVI). One current challenge of TAVI is the reduction of procedural stroke. Procedural mobilisation of debris is a known source of cerebral embolisation. Mechanical protection by transient filtration of cerebral blood flow might reduce the embolic burden during TAVI. We aimed to evaluate the feasibility and safety of the Claret CE Pro™ cerebral protection device in patients undergoing TAVI. Patients scheduled for TAVI were prospectively enrolled at three centres. The Claret CE Pro™ (Claret Medical, Inc. Santa Rosa, CA, USA) cerebral protection device was placed via the right radial/brachial artery prior to TAVI and was removed after the procedure. The primary endpoint was technical success rate. Secondary endpoints encompassed procedural and 30-day stroke rates, as well as device-related complications. Deployment of the Claret CE Pro™ cerebral protection device was intended for use in 40 patients, 35 devices were implanted into the aortic arch. Technical success rate with delivery of the proximal and distal filter was 60% for the first generation device and 87% for the second-generation device. Delivery times for the first-generation device were 12.4±12.1 minutes and 4.4 ± 2.5 minutes for the second-generation device (pto the Claret CE Pro System was 19.6 ± 3.8 ml. Captured debris was documented in at least 19 of 35 implanted devices (54.3%). No procedural transient ischaemic attacks, minor strokes or major strokes occurred. Thirty-day follow-up showed one minor stroke occurring 30 days after the procedure, and two major strokes both occurring well after the patient had completed TAVI. The use of the Claret CE Pro™ system is feasible and safe. Capture of debris in more than half of the patients provides evidence for the potential to reduce the procedural cerebral embolic burden utilising this dedicated filter

Tissue Variability and Antennas for Power Transfer to Wireless Implantable Medical Devices.

Science.gov (United States)

Bocan, Kara N; Mickle, Marlin H; Sejdic, Ervin

2017-01-01

The design of effective transcutaneous systems demands the consideration of inevitable variations in tissue characteristics, which vary across body areas, among individuals, and over time. The purpose of this paper was to design and evaluate several printed antenna topologies for ultrahigh frequency (UHF) transcutaneous power transfer to implantable medical devices, and to investigate the effects of variations in tissue properties on dipole and loop topologies. Here, we show that a loop antenna topology provides the greatest achievable gain with the smallest implanted antenna, while a dipole system provides higher impedance for conjugate matching and the ability to increase gain with a larger external antenna. In comparison to the dipole system, the loop system exhibits greater sensitivity to changes in tissue structure and properties in terms of power gain, but provides higher gain when the separation is on the order of the smaller antenna dimension. The dipole system was shown to provide higher gain than the loop system at greater implant depths for the same implanted antenna area, and was less sensitive to variations in tissue properties and structure in terms of power gain at all investigated implant depths. The results show the potential of easily-fabricated, low-cost printed antenna topologies for UHF transcutaneous power, and the importance of environmental considerations in choosing the antenna topology.

Tissue Variability and Antennas for Power Transfer to Wireless Implantable Medical Devices

Science.gov (United States)

Bocan, Kara N.; Mickle, Marlin H.

2017-01-01

The design of effective transcutaneous systems demands the consideration of inevitable variations in tissue characteristics, which vary across body areas, among individuals, and over time. The purpose of this paper was to design and evaluate several printed antenna topologies for ultrahigh frequency (UHF) transcutaneous power transfer to implantable medical devices, and to investigate the effects of variations in tissue properties on dipole and loop topologies. Here, we show that a loop antenna topology provides the greatest achievable gain with the smallest implanted antenna, while a dipole system provides higher impedance for conjugate matching and the ability to increase gain with a larger external antenna. In comparison to the dipole system, the loop system exhibits greater sensitivity to changes in tissue structure and properties in terms of power gain, but provides higher gain when the separation is on the order of the smaller antenna dimension. The dipole system was shown to provide higher gain than the loop system at greater implant depths for the same implanted antenna area, and was less sensitive to variations in tissue properties and structure in terms of power gain at all investigated implant depths. The results show the potential of easily-fabricated, low-cost printed antenna topologies for UHF transcutaneous power, and the importance of environmental considerations in choosing the antenna topology. PMID:29018637

Strains Around Abutment Teeth with Different Attachments Used for Implant-Assisted Distal Extension Partial Overdentures: An In Vitro Study.

Science.gov (United States)

ELsyad, Moustafa Abdou; Omran, Abdelbaset Omar; Fouad, Mohammed Mohammed

2017-01-01

The aim of this study was to evaluate and compare strain around abutment teeth with different attachments used for implant-assisted distal extension partial overdentures (IADEPODs). A mandibular Kennedy class I acrylic model (remaining teeth from first premolar to first premolar) was constructed. A conventional partial denture was constructed over the model (control, group 1). Two laboratory implants were then placed bilaterally in the first molar areas parallel to each other and perpendicular to the residual ridge. Three additional experimental partial overdentures (PODs) were constructed and connected to the implants using ball (group 2), magnetic (group 3), and Locator (group 4) attachments. Three linear strain gauges were bonded buccal, lingual, and distal to the first premolar abutment tooth at the right (loading) and the left (nonloading) sides. For each group, a universal testing device was used to apply a unilateral vertical static load (50 N) on the first molar area, and the strain was recorded using a multichannel digital strainometer. Significant differences between groups and between sites of strain gauges were detected. Strains recorded for all groups were compressive (negative) in nature. Group 1 demonstrated the highest strain, followed by group 3 and group 4; group 2 recorded the lowest strain. For group 2, the highest strain was recoded at the lingual nonloading side. For group 1, group 3, and group 4, the highest strain was recorded at the buccal loading side. Within the limitation of the present study, ball attachments used to retain IADEPODs to the implants were associated with lower strains around abutment teeth than Locator and magnetic attachments. The highest strain was recorded with conventional partial dentures. © 2015 by the American College of Prosthodontists.

Hip Implant Systems

Science.gov (United States)

... Implants and Prosthetics Metal-on-Metal Hip Implants Hip Implants Share Tweet Linkedin Pin it More sharing options Linkedin Pin it Email Print Hip implants are medical devices intended to restore mobility ...

Prodigiosin release from an implantable biomedical device: kinetics of localized cancer drug release

International Nuclear Information System (INIS)

Danyuo, Y.; Obayemi, J.D.; Dozie-Nwachukwu, S.; Ani, C.J.; Odusanya, O.S.; Oni, Y.; Anuku, N.; Malatesta, K.; Soboyejo, W.O.

2014-01-01

This paper presents an implantable encapsulated structure that can deliver localized heating (hyperthermia) and controlled concentrations of prodigiosin (a cancer drug) synthesized by bacteria (Serratia marcesce (subsp. marcescens)). Prototypical Poly-di-methyl-siloxane (PDMS) packages, containing well-controlled micro-channels and drug storage compartments, were fabricated along with a drug-storing polymer produced by free radical polymerization of Poly(N-isopropylacrylamide)(PNIPA) co-monomers of Acrylamide (AM) and Butyl-methacrylate (BMA). The mechanisms of drug diffusion of PNIPA-base gels were elucidated. Scanning Electron Microscopy (SEM) was also used to study the heterogeneous porous structure of the PNIPA-based gels. The release exponents, n, of the gels were found to between 0.5 and 0.7. This is in the range expected for Fickian (n = 0.5). Deviation from Fickian diffusion was also observed (n > 0.5) diffusion. The gel diffusion coefficients were shown to vary between 2.1 × 10 −12 m 2 /s and 4.8 × 10 −6 m 2 /s. The implications of the results are then discussed for the localized treatment of cancer via hyperthermia and the controlled delivery of prodigiosin from encapsulated PNIPA-based devices. - Highlights: • Fabricated thermo-sensitive hydrogels for localized drug release from an implantable biomedical device. • Determined the cancer drug diffusion mechanisms of PNIPA-co-AM copolymer hydrogel. • Encapsulated PNIPA-based hydrogels in PDMS capsules for controlled drug delivery. • Established the kinetics of drug release from gels and channels in an implantable biomedical device. • Demonstrated the potential for the controlled release of prodigiosin (PG) as an anticancer drug

Prodigiosin release from an implantable biomedical device: kinetics of localized cancer drug release

Energy Technology Data Exchange (ETDEWEB)

Danyuo, Y.; Obayemi, J.D.; Dozie-Nwachukwu, S. [Department of Materials Science and Engineering, African University of Science and Technology (AUST), Abuja, Federal Capital Territory (Nigeria); Ani, C.J. [Department of Theoretical Physics, African University of Science and Technology (AUST), Abuja, Federal Capital Territory (Nigeria); Odusanya, O.S. [Biotechnology and Genetic Engineering Advanced Laboratory, Sheda Science and Technology Complex (SHESTCO), Abuja, Federal Capital Territory (Nigeria); Oni, Y. [Department of Chemistry, Bronx Community College, New York, NY (United States); Anuku, N. [Department of Chemistry, Bronx Community College, New York, NY (United States); Princeton Institute for the Science and Technology of Materials (PRISM), 70 Prospect Street, Princeton, NJ 08544 (United States); Malatesta, K. [Department of Chemistry, Bronx Community College, New York, NY (United States); Soboyejo, W.O., E-mail: soboyejo@princeton.edu [Department of Materials Science and Engineering, African University of Science and Technology (AUST), Abuja, Federal Capital Territory (Nigeria); Princeton Institute for the Science and Technology of Materials (PRISM), 70 Prospect Street, Princeton, NJ 08544 (United States); Department of Mechanical and Aerospace Engineering 1 Olden Street, Princeton, NJ 08544 (United States)

2014-09-01

This paper presents an implantable encapsulated structure that can deliver localized heating (hyperthermia) and controlled concentrations of prodigiosin (a cancer drug) synthesized by bacteria (Serratia marcesce (subsp. marcescens)). Prototypical Poly-di-methyl-siloxane (PDMS) packages, containing well-controlled micro-channels and drug storage compartments, were fabricated along with a drug-storing polymer produced by free radical polymerization of Poly(N-isopropylacrylamide)(PNIPA) co-monomers of Acrylamide (AM) and Butyl-methacrylate (BMA). The mechanisms of drug diffusion of PNIPA-base gels were elucidated. Scanning Electron Microscopy (SEM) was also used to study the heterogeneous porous structure of the PNIPA-based gels. The release exponents, n, of the gels were found to between 0.5 and 0.7. This is in the range expected for Fickian (n = 0.5). Deviation from Fickian diffusion was also observed (n > 0.5) diffusion. The gel diffusion coefficients were shown to vary between 2.1 × 10{sup −12} m{sup 2}/s and 4.8 × 10{sup −6} m{sup 2}/s. The implications of the results are then discussed for the localized treatment of cancer via hyperthermia and the controlled delivery of prodigiosin from encapsulated PNIPA-based devices. - Highlights: • Fabricated thermo-sensitive hydrogels for localized drug release from an implantable biomedical device. • Determined the cancer drug diffusion mechanisms of PNIPA-co-AM copolymer hydrogel. • Encapsulated PNIPA-based hydrogels in PDMS capsules for controlled drug delivery. • Established the kinetics of drug release from gels and channels in an implantable biomedical device. • Demonstrated the potential for the controlled release of prodigiosin (PG) as an anticancer drug.

Multicentre clinical trial experience with the HeartMate 3 left ventricular assist device: 30-day outcomes.

Science.gov (United States)

Zimpfer, Daniel; Netuka, Ivan; Schmitto, Jan D; Pya, Yuriy; Garbade, Jens; Morshuis, Michiel; Beyersdorf, Friedhelm; Marasco, Silvana; Rao, Vivek; Damme, Laura; Sood, Poornima; Krabatsch, Thomas

2016-09-01

The objective of this study was to describe the operative experience and 30-day outcomes of patients implanted with the HeartMate 3 Left Ventricular Assist System (LVAS) during the Conformité Européenne (CE) Mark clinical trial. Adult patients met inclusion and exclusion criteria defining advanced-stage heart failure and included the indications of bridge to transplant and destination therapy. Operative parameters, outcomes, adverse events, physical status and quality-of-life parameters were assessed in the first 30 days after LVAS implant. Fifty patients were implanted with the HeartMate 3 at 10 centres in 6 countries. The 30-day survival rate was 98%. The median operative and cardiopulmonary bypass times were 200 (range: 95-585) min and 84 (range: 47-250) min, respectively. Patients required transfusion with packed red blood cells (3.6 ± 2.3 units), fresh frozen plasma (6.5 ± 5 units) and platelets (2 ± 1 units). Six patients (12%) required reoperation for postoperative bleeding and 10 patients (20%) did not require blood transfusion. The median intensive care time was 6 days (range: 1-112 days) and the total hospital stay was 28 days (range: 14-116 days). The most common adverse events were bleeding (15, 30%), arrhythmia (14, 28%) and infection (10, 20%). There were 2 (4%) strokes. The 30-day outcomes following implantation of the HeartMate 3 demonstrates excellent survival with low adverse event rates. The LVAD performed as intended with no haemolysis or device failure. NCT02170363. HeartMate 3™ CE Mark Clinical Investigation Plan (HM3 CE Mark). © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Usefulness of Tricuspid Annular Diameter to Predict Late Right Sided Heart Failure in Patients With Left Ventricular Assist Device.

Science.gov (United States)

Nakanishi, Koki; Homma, Shunichi; Han, Jiho; Takayama, Hiroo; Colombo, Paolo C; Yuzefpolskaya, Melana; Garan, Arthur R; Farr, Maryjane A; Kurlansky, Paul; Di Tullio, Marco R; Naka, Yoshifumi; Takeda, Koji

2018-07-01

Although late-onset right-sided heart failure is recognized as a clinical problem in the treatment of patients with left ventricular assist devices (LVADs), the mechanism and predictors are unknown. Tricuspid valve (TV) deformation leads to the restriction of the leaflet motion and decreased coaptation, resulting in a functional tricuspid regurgitation that may act as a surrogate marker of late right-sided heart failure. This study aimed to investigate the association of preoperative TV deformation (annulus dilatation and leaflet tethering) with late right-sided heart failure development after continuous-flow LVAD implantation. The study cohort consisted of 274 patients who underwent 2-dimensional echocardiography before LVAD implantation. TV annulus diameter and tethering distance were measured in an apical 4-chamber view. Late right-sided heart failure was defined as right-sided heart failure requiring readmission and medical and/or surgical treatment after initial LVAD implantation. During a mean follow-up of 25.1 ± 19.0 months after LVAD implantation, late right-sided heart failure occurred in 33 patients (12.0%). Multivariate Cox proportional hazard analysis demonstrated that TV annulus diameter (hazard ratio 1.221 per 1 mm, p right-sided heart failure development, whereas leaflet tethering distance was not. The best cut-off value of the TV annular diameter was 41 mm (area under the curve 0.787). Kaplan-Meier analysis showed that patients with dilated TV annulus (TV annular diameter ≥41 mm) exhibited a significantly higher late right-sided heart failure occurrence than those without TV annular enlargement (log-rank p right-sided heart failure after LVAD implantation. Copyright © 2018 Elsevier Inc. All rights reserved.

Left ventricular assist device as destination therapy: application of the payment-by-results approach for the device reimbursement.

Science.gov (United States)

Messori, Andrea; Trippoli, Sabrina; Bonacchi, Massimo; Sani, Guido

2009-08-01

Value-based methods are increasingly used to reimburse therapeutic innovation, and the payment-by-results approach has been proposed for handling interventions with limited therapeutic evidence. Because most left ventricular assist devices are supported by preliminary efficacy data, we examined the effectiveness data of the HeartMate (Thoratec Corp, Pleasanton, CA) device to explore the application of the payment-by-results approach to these devices and to develop a model for handling reimbursements. According to our model, after establishing the societal economic countervalue for each month of life saved, each patient treated with one such device is associated to the payment of this countervalue for every month of survival lived beyond the final date of estimated life expectancy without left ventricular assist devices. Our base-case analysis, which used the published data of 68 patients who received the HeartMate device, was run with a monthly countervalue of euro 5000, no adjustment for quality of life, and a baseline life expectancy of 150 days without left ventricular assist devices. Sensitivity analysis was aimed at testing the effect of quality of life adjustments and changes in life expectancy without device. In our base-case analysis, the mean total reimbursement per patient was euro 82,426 (range, euro 0 to euro 250,000; N = 68) generated as the sum of monthly payments. This average value was close to the current price of the HeartMate device (euro 75,000). Sensitivity testing showed that the base-case reimbursement of euro 82,426 was little influenced by variations in life expectancy, whereas variations in utility had a more pronounced impact. Our report delineates an innovative procedure for appropriately allocating economic resources in this area of invasive cardiology.

A 3-DOF SOI MEMS ultrasonic energy harvester for implanted devices

International Nuclear Information System (INIS)

Fowler, A G; Moheimani, S O R; Behrens, S

2013-01-01

This paper reports the design and testing of a microelectromechanical systems (MEMS) energy harvester that is designed to harvest electrical energy from an external source of ultrasonic waves. This mechanism is potentially suited to applications including the powering of implanted devices for biomedical applications. The harvester employs a novel 3-degree of freedom design, with electrical energy being generated from displacements of a proof mass via electrostatic transducers. A silicon-on-insulator MEMS process was used to fabricate the device, with experimental characterization showing that the harvester can generate 24.7 nW, 19.8 nW, and 14.5 nW of electrical power respectively through its x-, y-, and z-axis vibrational modes

Prevention of Cardiac Implantable Electronic Device Infections: Single Operator Technique with Use of Povidone-Iodine, Double Gloving, Meticulous Aseptic/Antiseptic Measures and Antibiotic Prophylaxis.

Science.gov (United States)

Manolis, Antonis S; Melita, Helen

2017-01-01

Cardiac implantable electronic device (CIED) implantation is complicated by infection still at a worrisome rate of 2-5%. Since early on during device implantation procedures, we have adopted an infection-preventive technique which has hitherto resulted in effective prevention of infections. Herein we present our results of applying this technique by a single operator in a prospective series of 762 consecutive patients undergoing device implantation. A meticulous search for and treatment of active, occult, or smoldering infection was undertaken preoperatively. An aseptic/antiseptic technique was used for implantation of each device. Skin preparation is thorough with initial cleansing performed with alcohol followed by povidone-iodine 10% solution, which is also used in the wound and inside the pocket. In addition, we routinely use double gloving, and IV antibiotic prophylaxis 1 hour before and for 48 hours afterwards followed by oral antibiotic for 2-3 days after discharge. The skin is closed with absorbable sutures. The study includes 382 patients having a new pacemaker (n = 333) or battery change, system upgrade or lead revision (n = 49), and 380 patients having a new implantable cardioverter-defibrillator (ICD) (n = 296) or device replacement/upgrade/lead revision (n = 84). The pacemaker group, aged 70.2 ± 16.5 years, includes 18% VVI, 49% DDD, 29% VDD, and 4% cardiac resynchronization therapy (CRT) devices. The ICD group, aged 61.3 ± 13.0 years, with a mean ejection fraction of 36 ± 13%, includes 325 ICD and 55 CRT implants. Over 26.6 ± 33.4 months for the pacemaker group and 36.6 ± 38.3 months for the ICD group, infection occurred in one patient in each group (0.26%) having a device replacement. A consistent and strict approach of aseptic/antiseptic technique with the use of double gloving and povidone-iodine solution within the pocket plus a 4-day regimen of antibiotic prophylaxis minimizes infections in CIED implants. © 2016 Wiley Periodicals, Inc.

Malfunctions of Implantable Cardiac Devices in Patients Receiving Proton Beam Therapy: Incidence and Predictors

International Nuclear Information System (INIS)

Gomez, Daniel R.; Poenisch, Falk; Pinnix, Chelsea C.; Sheu, Tommy; Chang, Joe Y.; Memon, Nada; Mohan, Radhe; Rozner, Marc A.; Dougherty, Anne H.

2013-01-01

Purpose: Photon therapy has been reported to induce resets of implanted cardiac devices, but the clinical sequelae of treating patients with such devices with proton beam therapy (PBT) are not well known. We reviewed the incidence of device malfunctions among patients undergoing PBT. Methods and Materials: From March 2009 through July 2012, 42 patients with implanted cardiac implantable electronic devices (CIED; 28 pacemakers and 14 cardioverter-defibrillators) underwent 42 courses of PBT for thoracic (23, 55%), prostate (15, 36%), liver (3, 7%), or base of skull (1, 2%) tumors at a single institution. The median prescribed dose was 74 Gy (relative biological effectiveness; range 46.8-87.5 Gy), and the median distance from the treatment field to the CIED was 10 cm (range 0.8-40 cm). Maximum proton and neutron doses were estimated for each treatment course. All CIEDs were checked before radiation delivery and monitored throughout treatment. Results: Median estimated peak proton and neutron doses to the CIED in all patients were 0.8 Gy (range 0.13-21 Gy) and 346 Sv (range 11-1100 mSv). Six CIED malfunctions occurred in 5 patients (2 pacemakers and 3 defibrillators). Five of these malfunctions were CIED resets, and 1 patient with a defibrillator (in a patient with a liver tumor) had an elective replacement indicator after therapy that was not influenced by radiation. The mean distance from the proton beam to the CIED among devices that reset was 7.0 cm (range 0.9-8 cm), and the mean maximum neutron dose was 655 mSv (range 330-1100 mSv). All resets occurred in patients receiving thoracic PBT and were corrected without clinical incident. The generator for the defibrillator with the elective replacement indicator message was replaced uneventfully after treatment. Conclusions: The incidence of CIED resets was about 20% among patients receiving PBT to the thorax. We recommend that PBT be avoided in pacing-dependent patients and that patients with any type of CIED receiving

Vocational Reintegration of Handicapped Workers with Assistive Devices

Science.gov (United States)

Cooper, N. E.

1977-01-01

Two approaches to vocational reintegration of handicapped workers are described: (1) adapting the disabled to the working environment through treatment, therapy, counseling, selective placement, and prostheses, and (2) adapting the working environment to particular handicaps, with the assistive device fitted to the machine or tool rather than to…

Early Healing Events around Titanium Implant Devices with Different Surface Microtopography: A Pilot Study in an In Vivo Rabbit Model

Directory of Open Access Journals (Sweden)

Ester Orsini

2012-01-01

Full Text Available In the present pilot study, the authors morphologically investigated sandblasted, acid-etched surfaces (SLA at very early experimental times. The tested devices were titanium plate-like implants with flattened wide lateral sides and jagged narrow sides. Because of these implant shape and placement site, the device gained a firm mechanical stability but the largest portion of the implant surface lacked direct contact with host bone and faced a wide peri-implant space rich in marrow tissue, intentionally created in order to study the interfacial interaction between metal surface and biological microenvironment. The insertion of titanium devices into the proximal tibia elicited a sequence of healing events. Newly formed bone proceeded through an early distance osteogenesis, common to both surfaces, and a delayed contact osteogenesis which seemed to follow different patterns at the two surfaces. In fact, SLA devices showed a more osteoconductive behavior retaining a less dense blood clot, which might be earlier and more easily replaced, and leading to a surface-conditioning layer which promotes osteogenic cell differentiation and appositional new bone deposition at the titanium surface. This model system is expected to provide a starting point for further investigations which clarify the early cellular and biomolecular events occurring at the metal surface.

Degradability of Polymers for Implantable Biomedical Devices

Science.gov (United States)

Lyu, SuPing; Untereker, Darrel

2009-01-01

Many key components of implantable medical devices are made from polymeric materials. The functions of these materials include structural support, electrical insulation, protection of other materials from the environment of the body, and biocompatibility, as well as other things such as delivery of a therapeutic drug. In such roles, the stability and integrity of the polymer, over what can be a very long period of time, is very important. For most of these functions, stability over time is desired, but in other cases, the opposite–the degradation and disappearance of the polymer over time is required. In either case, it is important to understand both the chemistry that can lead to the degradation of polymers as well as the kinetics that controls these reactions. Hydrolysis and oxidation are the two classes of reactions that lead to the breaking down of polymers. Both are discussed in detail in the context of the environmental factors that impact the utility of various polymers for medical device applications. Understanding the chemistry and kinetics allows prediction of stability as well as explanations for observations such as porosity and the unexpected behavior of polymeric composite materials in some situations. In the last part, physical degradation such interfacial delamination in composites is discussed. PMID:19865531

Novel nonsurgical left ventricular assist device and system.

Science.gov (United States)

Misiri, Juna; DeSimone, Christopher V; Park, Soon J; Kushwaha, Sudhir S; Friedman, Paul A; Bruce, Charles J; Asirvatham, Samuel J

2013-01-01

Treatment options for advanced stages of congestive heart failure remain limited. Left ventricular assist devices (LVADs) have emerged as a means to support failing circulation. However, these devices are not without significant risk such as major open chest surgery. We utilized a novel approach for device placement at the aorto-left atria continuity as a site to create a conduit capable of accommodating a percutaneous LVAD system. We designed and developed an expandable nitinol based device for placement at this site to create a shunt between the LA and aorta. Our experiments support this anatomic location as an accessible and feasible site for accommodation of an entirely percutaneous LVAD. The novelty of this approach would bypass the left ventricle, and thereby minimize complications and morbidities associated with current LVAD placement. Copyright © 2013 Elsevier Inc. All rights reserved.

Security Belt for Wireless Implantable Medical Devices.

Science.gov (United States)

Kulaç, Selman

2017-09-19

In this study, a new protective design compatible with existing non-secure systems was proposed, since it is focused on the secure communication of wireless IMD systems in all transmissions. This new protector is an external wearable device and appears to be a belt fitted around for the patients IMD implanted. However, in order to provide effective full duplex transmissions and physical layer security, some sophisticated transceiver antennas have been placed on the belt. In this approach, beam-focused multi-antennas in optimal positions on the belt are randomly switched when transmissions to the IMD are performed and multi-jammer switching with MRC combining or majority-rule based receiving techniques are applied when transmissions from the IMD are carried out. This approach can also reduce the power consumption of the IMDs and contribute to the prolongation of the IMD's battery life.

Renal Function and Outcomes With Use of Left Ventricular Assist Device Implantation and Inotropes in End-Stage Heart Failure: A Retrospective Single Center Study.

Science.gov (United States)

Verma, Sean; Bassily, Emmanuel; Leighton, Shane; Mhaskar, Rahul; Sunjic, Igor; Martin, Angel; Rihana, Nancy; Jarmi, Tambi; Bassil, Claude

2017-07-01

Left ventricular assist device (LVAD) and inotrope therapy serve as a bridge to transplant (BTT) or as destination therapy in patients who are not heart transplant candidates. End-stage heart failure patients often have impaired renal function, and renal outcomes after LVAD therapy versus inotrope therapy have not been evaluated. In this study, 169 patients with continuous flow LVAD therapy and 20 patients with continuous intravenous inotrope therapy were analyzed. The two groups were evaluated at baseline and at 3 and 6 months after LVAD or inotrope therapy was started. The incidence of acute kidney injury (AKI), need for renal replacement therapy (RRT), BTT rate, and mortality for 6 months following LVAD or inotrope therapy were studied. Results between the groups were compared using Mann-Whitney U test and Chi-square with continuity correction or Fischer's exact at the significance level of 0.05. Mean glomerular filtration rate (GFR) was not statistically different between the two groups, with P = 0.471, 0.429, and 0.847 at baseline, 3 and 6 months, respectively. The incidence of AKI, RRT, and BTT was not statistically different. Mortality was less in the inotrope group (P < 0.001). Intravenous inotrope therapy in end-stage heart failure patients is non-inferior for mortality, incidence of AKI, need for RRT, and renal function for 6-month follow-up when compared to LVAD therapy. Further studies are needed to compare the effectiveness of inotropes versus LVAD implantation on renal function and outcomes over a longer time period.

[Magnetic resonance imaging in patients with implantable devices for treatment of disturbed heart rhythm: review of the current situation].

Science.gov (United States)

Sviridova, A A

The question of the possibility of MRI scanning in patients with cardiac implantable electronic devices (CIED) appeared simultaneously with the introduction of MRI in clinical practice. A lot of in-vitro, in-vivo and clinical researches were performed to estimate wat going on with CIED in strong magnetic field and is it possible to perform some unified protocol of safe MRI-scanning for these patients. Recommendations were provided, but not for the wide practice. MRI remained strongly contraindicated for CIED patient. To meet the clinical need CIEM manufacturers changed the design of devices to made them MRI-compatible, including reducing of ferromagnetic components, additional filters, new software. Lead coil design was changed as well to minimize lead heating and electrical current induction. Now all leaders of CIED industry have in their portfolio all types of MRI-conditional implanted cardiac rhythm management devices (pacemakers, ICDs, CRTs). "Conditional" means MRI scanning can be done only under specific condition. For MRI device and lead in one system have to be from the same manufacturer. Now, if you need to implant the device, you must proceed from the fact that the patient is more likely to need an MRI in the future and choose the appropriate model, not forgetting that the electrodes should also be MRI-compatible.

The Impact of Obesity on Patients Bridged to Transplantation With Continuous-Flow Left Ventricular Assist Devices.

Science.gov (United States)

Clerkin, Kevin J; Naka, Yoshifumi; Mancini, Donna M; Colombo, Paolo C; Topkara, Veli K

2016-10-01

This study sought to determine if obese patients had worse post-left ventricular assist device (LVAD) implantation outcomes and if the implantation of an LVAD allowed for weight loss. Obesity is a risk factor for cardiovascular disease including heart failure. Obese heart failure patients have better outcomes than those with normal weight; however, obese patients have worse outcomes after heart transplantation. Patients were identified in the United Network for Organ Sharing (UNOS) database that underwent LVAD implantation as bridge to transplantation from May 2004 and April 2014, with follow-up through June 2014. Patients were grouped according to body mass index (BMI) based on the World Health Organization classification. Among 3,856 patients, the risk of death or delisting was not significantly different between BMI groups (p = 0.347). There was no increased risk of death (p = 0.234) or delisting (p = 0.918). The risk of complication requiring UNOS status upgrade was increased for those with class II obesity or greater (hazard ratio: 1.48; p = 0.004), driven by increased infection and thromboembolism. Obese patients had worse post-transplantation outcomes. Weight loss substantial enough to decrease BMI group was achieved by a small proportion of patients listed with class I obesity or greater (9.6% to 15.5%). Patients with obesity had similar freedom from death or delisting while on LVAD support. However, class II obese or greater patients had an increased risk of complications requiring UNOS status upgrade compared with those with normal BMI during LVAD support and decreased post-transplantation survival. Weight loss on device therapy was possible, but uncommon. Careful consideration is needed when a bridge to weight loss strategy is proposed. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Additively manufactured custom load-bearing implantable devices: grounds for caution

Directory of Open Access Journals (Sweden)

Elisabetta M Zanetti

2017-08-01

Full Text Available Background Additive manufacturing technologies are being enthusiastically adopted by the orthopaedic community since they are providing new perspectives and new possibilities. First applications were finalised for educational purposes, pre-operative planning, and design of surgical guides; recent applications also encompass the production of implantable devices where 3D printing can bring substantial benefits such as customization, optimization, and manufacturing of very complex geometries. The conceptual smoothness of the whole process may lead to the idea that any medical practitioner can use a 3D printer and her/his imagination to design and produce novel products for personal or commercial use. Aims Outlining how the whole process presents more than one critical aspects, still demanding further research in order to allow a safe application of this technology for fully-custom design, in particular confining attention to orthopaedic/orthodontic prostheses defined as components responding mainly to a structural function. Methods Current knowledge of mechanical properties of additively manufactured components has been examined along with reasons why the behaviour of these components might differ from traditionally manufactured components. The structural information still missing for mechanical design is outlined. Results Mechanical properties of additively manufactured components are not completely known, and especially fatigue limit needs to be examined further. Conclusion At the present stage, with reference to load-bearing implants subjected to many loading cycles, the indication of custom-made additively manufactured medical devices should be restricted to the cases with no viable alternative.

Autologous Cell Delivery to the Skin-Implant Interface via the Lumen of Percutaneous Devices in vitro

Directory of Open Access Journals (Sweden)

Antonio Peramo

2010-11-01

Full Text Available Induced tissue regeneration around percutaneous medical implants could be a useful method to prevent the failure of the medical device, especially when the epidermal seal around the implant is disrupted and the implant must be maintained over a long period of time. In this manuscript, a novel concept and technique is introduced in which autologous keratinocytes were delivered to the interfacial area of a skin-implant using the hollow interior of a fixator pin as a conduit. Full thickness human skin explants discarded from surgeries were cultured at the air-liquid interface and were punctured to fit at the bottom of hollow cylindrical stainless steel fixator pins. Autologous keratinocytes, previously extracted from the same piece of skin and cultured separately, were delivered to the specimens thorough the interior of the hollow pins. The delivered cells survived the process and resembled undifferentiated epithelium, with variations in size and shape. Viability was demonstrated by the lack of morphologic evidence of necrosis or apoptosis. Although the cells did not form organized epithelial structures, differentiation toward a keratinocyte phenotype was evident immunohistochemically. These results suggest that an adaptation of this technique could be useful for the treatment of complications arising from the contact between skin and percutaneous devices in vivo.

COST-EFFECTIVENESS OF CONTINUOUS-FLOW LEFT VENTRICULAR ASSIST DEVICES

NARCIS (Netherlands)

Neyt, Mattias; Van den Bruel, Ann; Smit, Yolba; De Jonge, Nicolaas; Erasmus, Michiel; Van Dijk, Diederik; Vlayen, Joan

Objectives: Mechanical circulatory support through left ventricular assist devices (LVADs) improves survival and quality of life for patients with end-stage heart failure who are ineligible for cardiac transplantation. Our aim was to calculate the cost-effectiveness of continuous-flow LVADs.

21 CFR 872.3645 - Subperiosteal implant material.

Science.gov (United States)

2010-04-01

... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3645 Subperiosteal implant material. (a) Identification. Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Subperiosteal implant material. 872.3645 Section...

Comparison Study of Percutaneous Osseointegrated Bone Conduction Device Complications When Using the 9 mm Abutment Versus 6 mm Abutment at Initial Implantation.

Science.gov (United States)

Wise, Sean R; LaRouere, Jacqueline S; Bojrab, Dennis I; LaRouere, Michael J

2018-04-01

To assess differences in the incidence, type, and management of complications encountered with implantation of percutaneous osseointegrated bone conduction devices when using a 9 mm abutment versus 6 mm abutment at initial implantation. Retrospective cohort study. One hundred thirty consecutive patients between January 2010 and December 2011 underwent single-stage percutaneous osseointegrated bone conduction device implantation using a 9 or 6 mm abutment. Clinical outcomes assessed for the two groups included the incidence, type, and management of postoperative complications. Abutment size, age, sex, indication for surgery, implant device type, duration of follow-up, and patient comorbidities were evaluated as potential factors affecting outcomes. Average duration of follow-up was 16 months (range 6-29 mo). Postoperative complications occurred in 38 (29.2%) patients. Twenty-four (18.4%) patients experienced minor complications requiring simple, local care; eight (6.1%) patients required in-office procedural intervention; and six (4.6%) patients required revision surgery in the operating room. Implant extrusion occurred in three (2.3%) patients. Eleven (8.5%) patients required placement of a longer abutment. Patients receiving the 6 mm abutment at initial surgery were significantly more likely to encounter a complication requiring in-office procedural intervention or revision surgery (p = 0.001). Minor complications after implantation of percutaneous osseointegrated bone conduction devices are common. The vast majority of these complications are due to localized skin reactions, most of which are readily addressed through local care. Patients receiving the 9 mm abutment during initial implantation are significantly less likely to require in-office procedural intervention or revision surgery postoperatively as compared with those receiving the shorter, 6 mm abutment.

Use of PTFE patch for pericardial closure after minimal invasive LVAD implantation.

Science.gov (United States)

Mohite, Prashant N; Sabashnikov, Anton; Popov, Aron F; Fatullayev, Javid; Simon, André R

2016-07-01

The left ventricular assist device (LVAD) is now a routine therapy for advanced heart failure. The thoracotomy approach for LVAD implantation, in which the left ventricle is approached through a pericardial rent, is becoming popular. We demonstrate closure of the pericardial rent with a polytetrafluoroethylene (PTFE) patch and its advantages. © The Author(s) 2015.

Integration of implant planning workflows into the PACS infrastructure

Science.gov (United States)

Gessat, Michael; Strauß, Gero; Burgert, Oliver

2008-03-01

The integration of imaging devices, diagnostic workstations, and image servers into Picture Archiving and Communication Systems (PACS) has had an enormous effect on the efficiency of radiology workflows. The standardization of the information exchange between the devices with the DICOM standard has been an essential precondition for that development. For surgical procedures, no such infrastructure exists. With the increasingly important role computerized planning and assistance systems play in the surgical domain, an infrastructure that unifies the communication between devices becomes necessary. In recent publications, the need for a modularized system design has been established. A reference architecture for a Therapy Imaging and Model Management System (TIMMS) has been proposed. It was accepted by the DICOM Working Group 6 as the reference architecture for DICOM developments for surgery. In this paper we propose the inclusion of implant planning systems into the PACS infrastructure. We propose a generic information model for the patient specific selection and positioning of implants from a repository according to patient image data. The information models are based on clinical workflows from ENT, cardiac, and orthopedic surgery as well as technical requirements derived from different use cases and systems. We show an exemplary implementation of the model for application in ENT surgery: the selection and positioning of an ossicular implant in the middle ear. An implant repository is stored in the PACS. It makes use of an experimental implementation of the Surface Mesh Module that is currently being developed as extension to the DICOM standard.

The role of ion-implantation in the realization of spintronic devices in diamond

Energy Technology Data Exchange (ETDEWEB)

Kalish, Rafi, E-mail: kalish@si-sun1.technion.ac.il [Physics Department and Solid State Institute, Technion-Israel Institute of Technology, Haifa 32000 (Israel)

2012-02-01

The application of single photons emitted by specific quantum systems is promising for quantum computers, cryptography and for other future nano-applications. These heavily rely on ion implantation both for selective single ion implantations as well as for the introduction of controlled damage with specific properties. Of particular promise is the negatively charged nitrogen-vacancy (NV{sup -}) defect center in diamond. This center has many desirable luminescence properties required for spintronic devices operational at room temperature, including a long relaxation time of the color center, emission of photons in the visible and the fact that it is produced in diamond, a material with outstanding mechanical and optical properties. This center is usually realized by nitrogen and/or vacancy producing ion implantations into diamond which, following annealing, leads to the formation of the desired NV{sup -} center. The single photons emitted by the decay of this center have to be transported to allow their exploitation. This can be best done by realizing very thin wave guides in single crystal diamond with/or without nano-scale cavities in the same diamond in which NV centers are produced. For this, advantage is taken of the unique property of heavily ion-damaged diamond to be converted, following annealing, to etchable graphite. Thus a free standing submicron thick diamond membrane containing the NV center can be obtained. If desirable, specific photonic crystal structures can be realized in them by the use of FIB. The various ion-implantation schemes used to produce NV centers in diamond, free standing diamond membranes, and photonic crystal structures in them are reviewed. The scientific problems and the technological challenges that have to be solved before actual practical realization of diamond based spintronic devices can be produced are discussed.

Security and privacy for implantable medical devices

CERN Document Server

Carrara, Sandro

2014-01-01

 This book presents a systematic approach to analyzing the challenging engineering problems posed by the need for security and privacy in implantable medical devices (IMD).  It describes in detail new issues termed as lightweight security, due to the associated constraints on metrics such as available power, energy, computing ability, area, execution time, and memory requirements. Coverage includes vulnerabilities and defense across multiple levels, with basic abstractions of cryptographic services and primitives such as public key cryptography, block ciphers and digital signatures. Experts from engineering introduce to some IMD systems that have  recently been proposed and developed. Experts from Computer Security and Cryptography present new research, which shows vulnerabilities in existing IMDs and proposes solutions. Experts from Privacy Technology and Policy will discuss the societal, legal and ethical challenges surrounding IMD security as well as technological solutions that build on the latest in C...

Clinical application of femtosecond laser assisted cataract surgery combined with triple-focus intraocular lens implantation in the treatment of cataract

Directory of Open Access Journals (Sweden)

Qing-Song Gao

2018-02-01

Full Text Available AIM:To evaluate the effect of femtosecond laser assisted cataract surgery combined with triple-focus intraocular lens implantation in the treatment of cataract. METHODS: Totally 86 cases(106 eyesof patients with double cataract in our hospital from January 2016 to January 2017 were selected, including 49 cases(59 eyeswere set as the observation group(treated with femtosecond laser assisted phacoemulsification combined with triple-focus intraocular lens implantation, and 37 cases(47 eyeswere set as the control group(received traditional phacoemulsification combined with triple-focus intraocular lens implantation. Corneal endothelial cell density, cumulative dissipated energy(CDE, distant and near visual accommodation before and after operation were compared between the two groups, postoperative complications were observed. RESULTS: The preoperative corneal endothelial cell density of two groups had no significant difference(P>0.05. The corneal endothelial cell density of two groups significantly decreased at postoperative 1wk, with statistic significance within groups(PPPPPP>0.05. The incidence of glare and halo in the observation group was 10.2% and 8.5% in the control group, and are in the patients whose age was above 60 years old, there was no significant difference between the two groups(P>0.05. CONCLUSION: Femtosecond laser assisted cataract surgery combined with triple-focus intraocular lens implantation in the treatment of cataract can not only improve curative effect, but also provide high safety, while the adverse events including glare, halo and other adverse visual circumstances should be considered after triple-focus intraocular lens implantation.

Monitoring mobility assistive device use in post-stroke patients

DEFF Research Database (Denmark)

Boissy, Patrice; Hester, Todd; Sherrill, Delsey

2007-01-01

Mobility assistive devices (MAD) such as canes can improve mobility and allow independence in the performance of mobility-related tasks. The use of MAD is often prescribed for stroke survivors. Despite their acknowledged qualities, MAD in real life conditions are typically underutilized, misused...

21 CFR 872.3640 - Endosseous dental implant.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant. 872.3640 Section 872...) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3640 Endosseous dental implant. (a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that...

Advanced processing of gallium nitride and gallium nitride-based devices: Ultra-high temperature annealing and implantation incorporation

Science.gov (United States)

Yu, Haijiang

into AlGaN/GaN high electron mobility transistor processing has been first demonstrated. An ultra-high temperature (1500°C) rapid thermal annealing technique was developed for the activation of Si dopants implanted in the source and drain. In comparison to control devices processed by conventional fabrication, the implanted device with nonalloyed ohmic contact showed comparable device performance with a contact resistance of 0.4 Omm Imax 730 mA/mm ft/f max; 26/62 GHz and power 3.4 W/mm on sapphire. These early results demonstrate the feasibility of implantation incorporation into GaN based device processing as well as the potential to increase yield, reproducibility and reliability in AlGaN/GaN HEMTs.

Hacking medical devices a review - biomed 2013.

Science.gov (United States)

Frenger, Paul

2013-01-01

Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as “hacking”. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (“buggy”) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States.

Anesthesia for gastrointestinal endoscopy in patients with left ventricular assist devices: Initial experience with 68 procedures

Directory of Open Access Journals (Sweden)

Basavana G Goudra

2013-01-01

Full Text Available Aims and Objectives: Continuous flow left ventricular assist devices (LVAD have emerged as a reliable treatment option for heart failure. Because of bleeding secondary to anticoagulation, these patients present frequently for gastrointestinal (GI endoscopy. The presently available literature on perioperative management of these patients is extremely limited and is primarily based upon theoretical principles. Materials and Methods: Perioperative records of patients with LVAD undergoing (GI endoscopy between 2008 and 2012 were reviewed. Patient, device and procedure specific information was analyzed. Results: A total of 105 LVADs were implanted, and 68 procedures were performed in 39 patients. The most common indication was GI bleed (48/68, with yearly risk of 8.57% per patient. A total of 63 procedures were performed under deep sedation, with five procedures requiring general anesthesia. Intra-procedure hypotension was managed by fluids and (or vasopressors/inotropes (phenylephrine, ephedrine or milrinone guided by plethysmographic waveform, non-invasive blood pressure (NIBP and LVADs pulsatility index (for HeartMate II/flow pulsatility (for HeartWare. No patient required invasive monitoring and both NIBP and pulse oximeter could be reliably used for monitoring (and guided management in all patients due to the presence of native heart′s pulsatile output. Conclusion: In the presence of residual heart function, with optimal device settings, non-invasive hemodynamic monitoring can be reliably used in these patients while undergoing GI endoscopy under general anesthesia or monitored anesthesia care. Transient hypotensive episodes respond well to fluids/vasopressors without the need of increasing device speed that can be detrimental.

Implant healing in experimental animal models of diabetes.

Science.gov (United States)

Le, Nga N; Rose, Michael B; Levinson, Howard; Klitzman, Bruce

2011-05-01

Diabetes mellitus is becoming increasingly prevalent worldwide. Additionally, there is an increasing number of patients receiving implantable devices such as glucose sensors and orthopedic implants. Thus, it is likely that the number of diabetic patients receiving these devices will also increase. Even though implantable medical devices are considered biocompatible by the Food and Drug Administration, the adverse tissue healing that occurs adjacent to these foreign objects is a leading cause of their failure. This foreign body response leads to fibrosis, encapsulation of the device, and a reduction or cessation of device performance. A second adverse event is microbial infection of implanted devices, which can lead to persistent local and systemic infections and also exacerbates the fibrotic response. Nearly half of all nosocomial infections are associated with the presence of an indwelling medical device. Events associated with both the foreign body response and implant infection can necessitate device removal and may lead to amputation, which is associated with significant morbidity and cost. Diabetes mellitus is generally indicated as a risk factor for the infection of a variety of implants such as prosthetic joints, pacemakers, implantable cardioverter defibrillators, penile implants, and urinary catheters. Implant infection rates in diabetic patients vary depending upon the implant and the microorganism, however, for example, diabetes was found to be a significant variable associated with a nearly 7.2% infection rate for implantable cardioverter defibrillators by the microorganism Candida albicans. While research has elucidated many of the altered mechanisms of diabetic cutaneous wound healing, the internal healing adjacent to indwelling medical devices in a diabetic model has rarely been studied. Understanding this healing process is crucial to facilitating improved device design. The purpose of this article is to summarize the physiologic factors that

Ion implantation for microelectronics

International Nuclear Information System (INIS)

Dearnaley, G.

1977-01-01

Ion implantation has proved to be a versatile and efficient means of producing microelectronic devices. This review summarizes the relevant physics and technology and assesses the advantages of the method. Examples are then given of widely different device structures which have been made by ion implantation. While most of the industrial application has been in silicon, good progress continues to be made in the more difficult field of compound semiconductors. Equipment designed for the industrial ion implantation of microelectronic devices is discussed briefly. (Auth.)

Magnet-assisted device-level alignment for the fabrication of membrane-sandwiched polydimethylsiloxane microfluidic devices

International Nuclear Information System (INIS)

Lu, J-C; Liao, W-H; Tung, Y-C

2012-01-01

Polydimethylsiloxane (PDMS) microfluidic device is one of the most essential techniques that advance microfluidics research in recent decades. PDMS is broadly exploited to construct microfluidic devices due to its unique and advantageous material properties. To realize more functionalities, PDMS microfluidic devices with multi-layer architectures, especially those with sandwiched membranes, have been developed for various applications. However, existing alignment methods for device fabrication are mainly based on manual observations, which are time consuming, inaccurate and inconsistent. This paper develops a magnet-assisted alignment method to enhance device-level alignment accuracy and precision without complicated fabrication processes. In the developed alignment method, magnets are embedded into PDMS layers at the corners of the device. The paired magnets are arranged in symmetric positions at each PDMS layer, and the magnetic attraction force automatically pulls the PDMS layers into the aligned position during assembly. This paper also applies the method to construct a practical microfluidic device, a tunable chaotic micromixer. The results demonstrate the successful operation of the device without failure, which suggests the accurate alignment and reliable bonding achieved by the method. Consequently, the fabrication method developed in this paper is promising to be exploited to construct various membrane-sandwiched PDMS microfluidic devices with more integrated functionalities to advance microfluidics research. (paper)

Management of severe ischemic cardiomyopathy: left ventricular assist device as destination therapy versus conventional bypass and mitral valve surgery.

Science.gov (United States)

Maltais, Simon; Tchantchaleishvili, Vahtang; Schaff, Hartzell V; Daly, Richard C; Suri, Rakesh M; Dearani, Joseph A; Topilsky, Yan; Stulak, John M; Joyce, Lyle D; Park, Soon J

2014-04-01

Patients with severe ischemic cardiomyopathy (left ventricular ejection fraction assist device as destination therapy is reserved for patients who are too high risk for conventional surgery. We evaluated our outcomes with conventional surgery within this population and the comparative effectiveness of these 2 therapies. We identified patients who underwent conventional surgery or left ventricular assist device as destination therapy for severe ischemic cardiomyopathy (left ventricular ejection fraction assist device as destination therapy. We compared baseline patient characteristics and outcomes in terms of end-organ function and survival. A total of 88 patients were identified; 55 patients underwent conventional surgery (63%), and 33 patients (37%) received a left ventricular assist device as destination therapy. Patients who received left ventricular assist device as destination therapy had the increased prevalence of renal failure, inotrope dependency, and intra-aortic balloon support. Patients undergoing conventional surgery required longer ventilatory support, and patients receiving a left ventricular assist device required more reoperation for bleeding. Mortality rates were similar between the 2 groups at 30 days (7% in the conventional surgery group vs 3% in the left ventricular assist device as destination therapy group, P = .65) and at 1 year (22% in the conventional surgery group vs 15% in the left ventricular assist device as destination therapy group, P = .58). There was a trend toward improved survival in patients receiving a left ventricular assist device compared with the propensity-matched groups at 1 year (94% vs 71%, P = .171). The operative mortality and early survival after conventional surgery seem to be acceptable. For inoperable or prohibitive-risk patients, left ventricular assist device as destination therapy can be offered with similar outcomes. Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby

Pre-implantation implantable cardioverter defibrillator concerns and Type D personality increase the risk of mortality in patients with an implantable cardioverter defibrillator

DEFF Research Database (Denmark)

Pedersen, Susanne S.; van den Broek, Krista C; Erdman, Ruud A M

2010-01-01

Little is known about the influence of psychological factors on prognosis in implantable cardioverter defibrillator (ICD) patients. We examined the influence of the distressed personality (Type D) and pre-implantation device concerns on short-term mortality in ICD patients.......Little is known about the influence of psychological factors on prognosis in implantable cardioverter defibrillator (ICD) patients. We examined the influence of the distressed personality (Type D) and pre-implantation device concerns on short-term mortality in ICD patients....

Feasibility and Safety of Endovascular Stripping of Totally Implantable Venous Access Devices

International Nuclear Information System (INIS)

Heye, Sam; Maleux, Geert; Goossens, G. A.; Vaninbroukx, Johan; Jerôme, M.; Stas, M.

2012-01-01

Purpose: To evaluate the safety and feasibility of percutaneous stripping of totally implantable venous access devices (TIVAD) in case of catheter-related sleeve and to report a technique to free the catheter tip from vessel wall adherence. Materials and Methods: A total of 37 stripping procedures in 35 patients (14 men, 40%, and 21 women, 60%, mean age 53 ± 14 years) were reviewed. Totally implantable venous access devices were implanted because of malignancy in most cases (85.7%). Catheter-related sleeve was confirmed as cause of persistent catheter dysfunction despite instillation of thrombolytics. A technique to mobilize the catheter tip from the vessel wall was used when stripping with the snare catheter was impossible. Technical success, complication rate, and outcome were noted. Results: A total of 55.9% (n = 19) of the 34 technically successful procedures (91.9%) could be done with the snare catheter. In 15 cases (44.1%), additional maneuvers to free the TIVAD’s tip from the vessel wall were needed. Success rate was not significantly lower before (72.4%) than after (96.7%) implementation of the new technique (P = 0.09). No complications were observed. Follow-up was available in 67.6% of cases. Recurrent catheter dysfunction was found in 17 TIVADs (78.3%) at a mean of 137.7 days and a median of 105 days. Conclusions: Stripping of TIVADs is technically feasible and safe, with an overall success rate of 91.9%. Additional endovascular techniques to mobilize the distal catheter tip from the wall of the superior vena cava or right atrium to allow encircling the TIVAD tip with the snare catheter may be needed in 44.1% of cases.

21 CFR 872.3980 - Endosseous dental implant accessories.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant accessories. 872.3980... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3980 Endosseous dental implant accessories. (a) Identification. Endosseous dental implant accessories are manually powered devices intended...

Intraoperative bronchoscopic visualization of left ventricular assist device thrombus.

Science.gov (United States)

Yost, Gardner; Bhat, Geetha; Modi, Sejal; Pappas, Pat; Tatooles, Antone

2016-07-01

Despite advancements in left ventricular assist device (LVAD) design and clinical management, device thrombosis remains a pertinent complication. Limited imaging makes precise visualization of clot location and shape very challenging. We report the usage of videobronchoscopic exploration of explanted LVADs for direct visualization of clot in two patients. This technique is a rapid and inexpensive means of improving our understanding of LVAD clot formation and may be useful in surgical exploration of inflow and outflow tracts during LVAD exchange. © The Author(s) 2015.

Endocarditis in left ventricular assist device

Science.gov (United States)

Thyagarajan, Braghadheeswar; Kumar, Monisha Priyadarshini; Sikachi, Rutuja R; Agrawal, Abhinav

2016-01-01

Summary Heart failure is one of the leading causes of death in developed nations. End stage heart failure often requires cardiac transplantation for survival. The left ventricular assist device (LVAD) has been one of the biggest evolvements in heart failure management often serving as bridge to transplant or destination therapy in advanced heart failure. Like any other medical device, LVAD is associated with complications with infections being reported in many patients. Endocarditis developing secondary to the placement of LVAD is not a frequent, serious and difficult to treat condition with high morbidity and mortality. Currently, there are few retrospective studies and case reports reporting the same. In our review, we found the most common cause of endocarditis in LVAD was due to bacteria. Both bacterial and fungal endocarditis were associated with high morbidity and mortality. In this review we will be discussing the risk factors, organisms involved, diagnostic tests, management strategies, complications, and outcomes in patients who developed endocarditis secondary to LVAD placement. PMID:27672540

Medical implants and methods of making medical implants

Science.gov (United States)

Shaw, Wendy J; Yonker, Clement R; Fulton, John L; Tarasevich, Barbara J; McClain, James B; Taylor, Doug

2014-09-16

A medical implant device having a substrate with an oxidized surface and a silane derivative coating covalently bonded to the oxidized surface. A bioactive agent is covalently bonded to the silane derivative coating. An implantable stent device including a stent core having an oxidized surface with a layer of silane derivative covalently bonded thereto. A spacer layer comprising polyethylene glycol (PEG) is covalently bonded to the layer of silane derivative and a protein is covalently bonded to the PEG. A method of making a medical implant device including providing a substrate having a surface, oxidizing the surface and reacting with derivitized silane to form a silane coating covalently bonded to the surface. A bioactive agent is then covalently bonded to the silane coating. In particular instances, an additional coating of bio-absorbable polymer and/or pharmaceutical agent is deposited over the bioactive agent.

Bridge to transplantation using paracorporeal biventricular assist devices or the syncardia temporary total artificial heart: is there a difference?

Science.gov (United States)

Nguyen, A; Pozzi, M; Mastroianni, C; Léger, P; Loisance, D; Pavie, A; Leprince, P; Kirsch, M

2015-06-01

Biventricular support can be achieved using paracorporeal ventricular assist devices (p-BiVAD) or the Syncardia temporary total artificial heart (t-TAH). The purpose of the present study was to compare survival and morbidity between these devices. Data from 2 French neighboring hospitals were reviewed. Between 1996 and 2009, 148 patients (67 p-BiVADs and 81 t-TAH) underwent primary, planned biventricular support. There were 128 (86%) males aged 44±13 years. Preoperatively, p-BiVAD recipients had significantly lower systolic and diastolic blood pressures, more severe hepatic cytolysis and higher white blood cell counts than t-TAH recipients. In contrast, t-TAH patients had significantly higher rates of pre-implant ECLS and hemofiltration. Mean support duration was 79±100 days for the p-BiVAD group and 71±92 for t-TAH group (P=0.6). Forty two (63%) p-BiVAD recipients were bridged to transplantation (39, 58%) or recovery (3, 5%), whereas 51 (63%) patients underwent transplantation in the t-TAH group. Death on support was similar between groups (p-BiVAD, 26 (39%); t-TAH, 30 (37%); P=0.87). Survival while on device was not significantly different between patient groups and multivariate analysis showed that only preimplant diastolic blood pressure and alanine amino-transferase levels were significant predictors of death. Post-transplant survival in the p-BiVAD group was 76±7%, 70±8%, and 58±9% at 1, 3, and 5 years after transplantation, respectively, and was similar to that of the t-TAH group (77±6%, 72±6%, and 70±7%, P=0.60). Survival while on support and up to 5 years after heart transplantation was not significantly different in patients supported by p-BiVADs or t-TAH. Multivariate analysis revealed that survival while on transplantation was not affected by the type of device implanted.

Simulation of Ventricular, Cavo-Pulmonary, and Biventricular Ventricular Assist Devices in Failing Fontan.

Science.gov (United States)

Di Molfetta, Arianna; Amodeo, Antonio; Fresiello, Libera; Trivella, Maria Giovanna; Iacobelli, Roberta; Pilati, Mara; Ferrari, Gianfranco

2015-07-01

Considering the lack of donors, ventricular assist devices (VADs) could be an alternative to heart transplantation for failing Fontan patients, in spite of the lack of experience and the complex anatomy and physiopathology of these patients. Considering the high number of variables that play an important role such as type of Fontan failure, type of VAD connection, and setting (right VAD [RVAD], left VAD [LVAD], or biventricular VAD [BIVAD]), a numerical model could be useful to support clinical decisions. The aim of this article is to develop and test a lumped parameter model of the cardiovascular system simulating and comparing the VAD effects on failing Fontan. Hemodynamic and echocardiographic data of 10 Fontan patients were used to simulate the baseline patients' condition using a dedicated lumped parameter model. Starting from the simulated baseline and for each patient, a systolic dysfunction, a diastolic dysfunction, and an increment of the pulmonary vascular resistance were simulated. Then, for each patient and for each pathology, the RVAD, LVAD, and BIVAD implantations were simulated. The model can reproduce patients' baseline well. In the case of systolic dysfunction, the LVAD unloads the single ventricle and increases the cardiac output (CO) (35%) and the arterial systemic pressure (Pas) (25%). With RVAD, a decrement of inferior vena cava pressure (Pvci) (39%) was observed with 34% increment of CO, but an increment of the single ventricle external work (SVEW). With the BIVAD, an increment of Pas (29%) and CO (37%) was observed. In the case of diastolic dysfunction, the LVAD increases CO (42%) and the RVAD decreases the Pvci, while both increase the SVEW. In the case of pulmonary vascular resistance increment, the highest CO (50%) and Pas (28%) increment is obtained with an RVAD with the highest decrement of Pvci (53%) and an increment of the SVEW but with the lowest VAD power consumption. The use of numerical models could be helpful in this innovative

Recent progress in the development of Terumo implantable left ventricular assist system.

Science.gov (United States)

Nojiri, C; Kijima, T; Maekawa, J; Horiuchi, K; Kido, T; Sugiyama, T; Mori, T; Sugiura, N; Asada, T; Shimane, H; Ozaki, T; Suzuki, M; Akamatsu, T; Akutsu, T

1999-01-01

The research group of the Terumo Corporation, the NTN Corporation, and Setsunan University (T. Akamatsu) has been developing an implantable left ventricular assist system (ILVAS) featuring a centrifugal blood pump with a magnetically suspended impeller (MSCP). The impeller of the MSCP is suspended by a magnetic bearing, providing contact-free rotation of the impeller inside the pump housing. Thus the MSCP is expected to provide years of long-term durability. Ex vivo chronic sheep experiments using the extracorporeal model (Model I) demonstrated long-term durability, nonthrombogenicity, and a low hemolysis rate (plasma free Hb model (Model II; 196 ml, 400 g) was evaluated ex vivo in 2 sheep and intrathoracically implanted in a small sheep (45 kg). These experiments were terminated at 70, 79, and 17 days, respectively, because of blood leakage through the connector system within the housing of Model II. There was no thrombus formation on the retrieved pump surfaces. A new connector system was introduced to the Model II pump (modified Model II), and the pump was intrathoracically implanted in a sheep. Pump flow rate was maintained at 3-7 L/min at 1700-1800 rpm. The temperature elevation on the surfaces of the motor and the electromagnet inside the pump casing was kept less than 6 degrees C. The temperature of the tissue adjacent to the pump casing became normal 10 days postoperatively. The sheep survived for more than 5 months without any sign of mechanical failure or thromboembolic complication. In vitro real-time endurance tests of motor bearings made of stainless steel and silicone nitride have been conducted for more than 1 year without any sign of bearing wear. The next prototype system (Model III), with an implantable controller and a new MSCP with reduced input power, has been developed with a view toward a totally implantable LVAS.

Therapeutic value of 3-D printing template-assisted 125I-seed implantation in the treatment of malignant liver tumors

Directory of Open Access Journals (Sweden)

Han T

2017-07-01

Full Text Available Tao Han,1,* Xiaodan Yang,1,* Ying Xu,2,* Zhendong Zheng,1,* Ying Yan,2 Ning Wang2 1Department of Oncology, 2Department of Radiotherapy, General Hospital of Shenyang Military Region, Shenyang, China *These authors contributed equally to this work Objective: To explore the therapeutic value of 3-D printing template-assisted 125I-seed implantation in the treatment of malignant liver tumors.Materials and methods: Fifteen liver cancer patients with 47 total lesions were treated with 3-D printing template-assisted radioactive seed implantation (group A, and 25 liver-tumor patients with 66 total lesions were treated with 125I-seed implantation without a template auxiliary (group B. Operation time, in-hospital time, operation complications, dose distribution, and response rate (number were compared between the two groups. Results: Shorter operation times and better dose distribution were observed in group A than in group B, and the differences were statistically significant. The response rate after 2 months was 86.7% (13 of 15 in group A and 84% (21 of 25 in group B; differences between the two groups were not significant.Conclusion: Application of 3-D printing template-assisted radioactive seed implantation in the treatment of malignant liver tumors can help shorten operation time and optimize radiation-dose distribution, is worthy of further study, and has clinical significance. Keywords: brachytherapy, stereotactic techniques, iodine isotopes, liver, carcinoma 

Development of Hand Grip Assistive Device Control System for Old People through Electromyography (EMG Signal Acquisitions

Directory of Open Access Journals (Sweden)

Khamis Herman

2017-01-01

Full Text Available The hand grip assistive device is a glove to assist old people who suffer from hand weakness in their daily life activities. The device earlier control system only use simple on and off switch. This required old people to use both hand to activate the device. The new control system of the hand grip assistive device was developed to allow single hand operation for old people. New control system take advantages of electromyography (EMG and flex sensor which was implemented to the device. It was programmed into active and semi-active mode operation. EMG sensors were placed on the forearm to capture EMG signal of Flexor Digitorum Profundus muscle to activate the device. Flex sensor was used to indicate the finger position and placed on top of the finger. The signal from both sensors then used to control the device. The new control system allowed single hand operation and designed to prevent user from over depended on the device by activating it through moving their fingers.

Arthroscopically assisted reduction of acute acromioclavicular joint dislocation using a single double-button device: Medium-term clinical and radiological outcomes.

Science.gov (United States)

Issa, S-P; Payan, C; Le Hanneur, M; Loriaut, P; Boyer, P

2018-02-01

Double-button devices for endoscopic management of acute acromioclavicular joint dislocation (ACJD) provide satisfactory short-term functional and radiological results. However, little exists in the literature regarding the long- and medium-term results of these implants, especially regarding the evolution of the acromioclavicular joint (ACJ). Satisfactory and steady long- and medium-term outcomes can be achieved in patients with acute ACJD undergoing endoscopically assisted ACJ repair using a single double-button device. A retrospective single-center study was conducted in patients with acute Rockwood III and IV ACJD treated endoscopically with a single double-button device from October 2008 to October 2010, allowing a minimum 5-year follow-up. Functional evaluation used Constant and Quick-DASH scores. Clinical evidence of dislocation recurrence was combined with bilateral Zanca views to assess coracoclavicular distance. Acromioclavicular osteoarthritis was evaluated on the Paxinos test and Zanca views. Nineteen of the 25 operated patients were seen at a mean 76.9±8.5 months' follow-up. Mean age was 34.4±8.3 years. Mean Constant and Quick-DASH scores were 96.2±5.1 and 0.9±1.6 points, respectively. Four patients had a recurrence of their initial dislocation, 3 of whom had positive Paxinos test, whereas the 15 patients without recurrence had a negative test (p=0.004). Five patients had radiological evidence of ACJ osteoarthritis: all 4 patients with recurrence and 1 without (p=0.001). Long- and medium-term radioclinical outcome of endoscopically assisted management of acute ACJD using a single double-button device seems to be satisfactory and steady over time. Recurrence of the initial dislocation appears to be related to onset of degenerative ACJ arthropathy. Therapeutic type IV-Retrospective case series. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Osteogenic protein 1 device increases bone formation and bone graft resorption around cementless implants

DEFF Research Database (Denmark)

Jensen, Thomas B; Overgaard, Søren; Lind, Martin

2002-01-01

In each femoral condyle of 8 Labrador dogs, a non weight-bearing hydroxyapatite-coated implant was inserted surrounded by a 3 mm gap. Each gap was filled with bone allograft or ProOsteon with or without OP-1 delivered in a bovine collagen type I carrier (OP-1 device). 300 microg OP-1 was used...

Remote monitoring of cardiovascular implanted electronic devices: a paradigm shift for the 21st century.

Science.gov (United States)

Cronin, Edmond M; Varma, Niraj

2012-07-01

Traditional follow-up of cardiac implantable electronic devices involves the intermittent download of largely nonactionable data. Remote monitoring represents a paradigm shift from episodic office-based follow-up to continuous monitoring of device performance and patient and disease state. This lessens device clinical burden and may also lead to cost savings, although data on economic impact are only beginning to emerge. Remote monitoring technology has the potential to improve the outcomes through earlier detection of arrhythmias and compromised device integrity, and possibly predict heart failure hospitalizations through integration of heart failure diagnostics and hemodynamic monitors. Remote monitoring platforms are also huge databases of patients and devices, offering unprecedented opportunities to investigate real-world outcomes. Here, the current status of the field is described and future directions are predicted.

Protocol updated for the treatment of patients in radiotherapy with implanted cardiac devices

International Nuclear Information System (INIS)

Martin Martin, G.; Bermudez Luna, R.; Rodriguez Rodriguez, C.; Lopez Fernandez, A.; Rodriguez Perez, A.; Sotoca Ruiz, A.

2013-01-01

Radiotherapy treatment can be safely performed in patients with pacemakers or implanted defibrillators, however, it is very important to ensure that the patient receives the minimum dose possible in your heart device. Is considered essential good coordination with the cardiology service before, during and after radiotherapy treatment for the patient safety. Finally we present a protocol updated to treat these patients in radiotherapy. (Author)

Implantation doping of GaN

International Nuclear Information System (INIS)

Zolper, J.C.

1996-01-01

Ion implantation has played an enabling role in the realization of many high performance photonic and electronic devices in mature semiconductor materials systems such as Si and GaAs. This can also be expected to be the case in III-Nitride based devices as the material quality continues to improve. This paper reviews the progress in ion implantation processing of the III-Nitride materials, namely, GaN, AlN, InN and their alloys. Details are presented of the successful demonstrations of implant isolation as well as n- and p-type implantation doping of GaN. Implant doping has required activation annealing at temperatures in excess of 1,000 C. The nature of the implantation induced damage and its response to annealing is addressed using Rutherford Backscattering. Finally, results are given for the first demonstration of a GaN device fabricated using ion implantation doping, a GaN junction field effect transistor (JFET)

Impact of long term left ventricular assist device therapy on donor allocation in cardiac transplantation.

Science.gov (United States)

Uriel, Nir; Jorde, Ulrich P; Woo Pak, Sang; Jiang, Jeff; Clerkin, Kevin; Takayama, Hiroo; Naka, Yoshifumi; Schulze, P Christian; Mancini, Donna M

2013-02-01

Left Ventricular Assist Devices (LVAD) are increasingly used as a bridge to transplant (BTT) for patients with advanced congestive heart failure (CHF) and are assigned United Network for Organ Sharing (UNOS) high priority status (1B or 1A). The purpose of our study was asses the effect of organ allocation in the era of continuous flow pumps. A retrospective chart review was performed of all patients transplanted between 1/2001-1/2011 at Columbia University Medical Center. Seven hundred twenty six adult heart transplantations were performed. Two hundred seventy four BTT patients were implanted with LVAD; of which 227 patients were transplanted. Sixty three patients were transplanted as UNOS-1B, while 164 were transplanted as UNOS-1A (72%). Of these 164 patients, 65 were transplanted during their 30-day 1A period (43%) and 96 after upgrading to UNOS-1A for device complication (56%). For 452 non-device patients 139 (31%) were transplanted as UNOS-1A, 233 as UNOS-1B (52%), and 80 as UNOS-2 (17%). The percentage of patients bridged with LVAD increased from 19% in 2001 to 64% in 2010 while the number transplanted during their 30 day 1A grace period declined from 57% in 2005 to 16% in 2011; i.e. 84% of BTT patients in 2011 needed more than 30 days 1A time to be transplanted. Most LVAD patients are now transplanted while suffering device complication. There was no difference in post transplant survival between LVAD patients transplanted as UNOS 1B, 1A grace period or for a device complication As wait time for cardiac transplantation increased the percentage of patients being bridged to transplant with an LVAD has increased with the majority of them transplanted in the setting of device complication. Copyright © 2013 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

Awake craniotomy for assisting placement of auditory brainstem implant in NF2 patients.

Science.gov (United States)

Zhou, Qiangyi; Yang, Zhijun; Wang, Zhenmin; Wang, Bo; Wang, Xingchao; Zhao, Chi; Zhang, Shun; Wu, Tao; Li, Peng; Li, Shiwei; Zhao, Fu; Liu, Pinan

2018-06-01

Auditory brainstem implants (ABIs) may be the only opportunity for patients with NF2 to regain some sense of hearing sensation. However, only a very small number of individuals achieved open-set speech understanding and high sentence scores. Suboptimal placement of the ABI electrode array over the cochlear nucleus may be one of main factors for poor auditory performance. In the current study, we present a method of awake craniotomy to assist with ABI placement. Awake surgery and hearing test via the retrosigmoid approach were performed for vestibular schwannoma resections and auditory brainstem implantations in four patients with NF2. Auditory outcomes and complications were assessed postoperatively. Three of 4 patients who underwent awake craniotomy during ABI surgery received reproducible auditory sensations intraoperatively. Satisfactory numbers of effective electrodes, threshold levels and distinct pitches were achieved in the wake-up hearing test. In addition, relatively few electrodes produced non-auditory percepts. There was no serious complication attributable to the ABI or awake craniotomy. It is safe and well tolerated for neurofibromatosis type 2 (NF2) patients using awake craniotomy during auditory brainstem implantation. This method can potentially improve the localization accuracy of the cochlear nucleus during surgery.

Thin-film Rechargeable Lithium Batteries for Implantable Devices

Science.gov (United States)

Bates, J. B.; Dudney, N. J.

1997-05-01

Thin films of LiCoO{sub 2} have been synthesized in which the strongest x ray reflection is either weak or missing, indicating a high degree of preferred orientation. Thin film solid state batteries with these textured cathode films can deliver practical capacities at high current densities. For example, for one of the cells 70% of the maximum capacity between 4.2 V and 3 V ({approximately}0.2 mAh/cm{sup 2}) was delivered at a current of 2 mA/cm{sup 2}. When cycled at rates of 0.1 mA/cm{sup 2}, the capacity loss was 0.001%/cycle or less. The reliability and performance of Li LiCoO{sub 2} thin film batteries make them attractive for application in implantable devices such as neural stimulators, pacemakers, and defibrillators.

Exploiting spatial degrees of freedom for high data rate ultrasound communication with implantable devices

Science.gov (United States)

Wang, Max L.; Arbabian, Amin

2017-09-01

We propose and demonstrate an ultrasonic communication link using spatial degrees of freedom to increase data rates for deeply implantable medical devices. Low attenuation and millimeter wavelengths make ultrasound an ideal communication medium for miniaturized low-power implants. While a small spectral bandwidth has drastically limited achievable data rates in conventional ultrasonic implants, a large spatial bandwidth can be exploited by using multiple transducers in a multiple-input/multiple-output system to provide spatial multiplexing gain without additional power, larger bandwidth, or complicated packaging. We experimentally verify the communication link in mineral oil with a transmitter and a receiver 5 cm apart, each housing two custom-designed mm-sized piezoelectric transducers operating at the same frequency. Two streams of data modulated with quadrature phase-shift keying at 125 kbps are simultaneously transmitted and received on both channels, effectively doubling the data rate to 250 kbps with a measured bit error rate below 10-4. We also evaluate the performance and robustness of the channel separation network by testing the communication link after introducing position offsets. These results demonstrate the potential of spatial multiplexing to enable more complex implant applications requiring higher data rates.

CT-guided localization of small pulmonary nodules using adjacent microcoil implantation prior to video-assisted thoracoscopic surgical resection

Energy Technology Data Exchange (ETDEWEB)

Su, Tian-Hao; Jin, Long; He, Wen [Capital Medical University, Department of Radiology, Beijing Friendship Hospital, Beijing (China); Fan, Yue-Feng [Xiamen University, Department of Interventional Therapy, The First Affiliated Hospital, Xiamen, Fujian (China); Hu, Li-Bao [Peking University People' s Hospital, Department of Radiology, Beijing (China)

2015-09-15

To describe and assess the localization of small peripheral pulmonary nodules prior to video-assisted thoracoscopic surgical (VATS) resection using the implantation of microcoils. Ninety-two patients with 101 pulmonary nodules underwent computed tomography (CT)-guided implantation of microcoils proximal to each nodule. Patients were randomly assigned to undergo entire microcoil or leaving-microcoil-end implantations. The complications and efficacy of the two implantation methods were evaluated. VATS resection of lung tissue containing each pulmonary lesion and microcoil were performed in the direction of the microcoil marker. Histopathological analysis was performed for the resected pulmonary lesions. CT-guided microcoil implantation was successful in 99/101 cases, and the placement of microcoils within 1 cm of the nodules was not disruptive. There was no difference in the complications and efficacy associated with the entire implantation method (performed for 51/99 nodules) versus the leaving-microcoil-end implantation method (performed for 48/99 nodules). All nodules were successfully removed using VATS resection. Asymptomatic pneumothorax occurred in 16 patients and mild pulmonary haemorrhage occurred in nine patients. However, none of these patients required further surgical treatment. Preoperative localization of small pulmonary nodules using a refined percutaneous microcoil implantation method was found to be safe and useful prior to VATS resection. (orig.)

Finite volume analysis of temperature effects induced by active MRI implants with cylindrical symmetry: 1. Properly working devices

Directory of Open Access Journals (Sweden)

Schnorr Jörg

2005-04-01

Full Text Available Abstract Background Active Magnetic Resonance Imaging implants are constructed as resonators tuned to the Larmor frequency of a magnetic resonance system with a specific field strength. The resonating circuit may be embedded into or added to the normal metallic implant structure. The resonators build inductively coupled wireless transmit and receive coils and can amplify the signal, normally decreased by eddy currents, inside metallic structures without affecting the rest of the spin ensemble. During magnetic resonance imaging the resonators generate heat, which is additional to the usual one described by the specific absorption rate. This induces temperature increases of the tissue around the circuit paths and inside the lumen of an active implant and may negatively influence patient safety. Methods This investigation provides an overview of the supplementary power absorbed by active implants with a cylindrical geometry, corresponding to vessel implants such as stents, stent grafts or vena cava filters. The knowledge of the overall absorbed power is used in a finite volume analysis to estimate temperature maps around different implant structures inside homogeneous tissue under worst-case assumptions. The "worst-case scenario" assumes thermal heat conduction without blood perfusion inside the tissue around the implant and mostly without any cooling due to blood flow inside vessels. Results The additional power loss of a resonator is proportional to the volume and the quality factor, as well as the field strength of the MRI system and the specific absorption rate of the applied sequence. For properly working devices the finite volume analysis showed only tolerable heating during MRI investigations in most cases. Only resonators transforming a few hundred mW into heat may reach temperature increases over 5 K. This requires resonators with volumes of several ten cubic centimeters, short inductor circuit paths with only a few 10 cm and a quality

Finite volume analysis of temperature effects induced by active MRI implants with cylindrical symmetry: 1. Properly working devices.

Science.gov (United States)

Busch, Martin H J; Vollmann, Wolfgang; Schnorr, Jörg; Grönemeyer, Dietrich H W

2005-04-08

Active Magnetic Resonance Imaging implants are constructed as resonators tuned to the Larmor frequency of a magnetic resonance system with a specific field strength. The resonating circuit may be embedded into or added to the normal metallic implant structure. The resonators build inductively coupled wireless transmit and receive coils and can amplify the signal, normally decreased by eddy currents, inside metallic structures without affecting the rest of the spin ensemble. During magnetic resonance imaging the resonators generate heat, which is additional to the usual one described by the specific absorption rate. This induces temperature increases of the tissue around the circuit paths and inside the lumen of an active implant and may negatively influence patient safety. This investigation provides an overview of the supplementary power absorbed by active implants with a cylindrical geometry, corresponding to vessel implants such as stents, stent grafts or vena cava filters. The knowledge of the overall absorbed power is used in a finite volume analysis to estimate temperature maps around different implant structures inside homogeneous tissue under worst-case assumptions. The "worst-case scenario" assumes thermal heat conduction without blood perfusion inside the tissue around the implant and mostly without any cooling due to blood flow inside vessels. The additional power loss of a resonator is proportional to the volume and the quality factor, as well as the field strength of the MRI system and the specific absorption rate of the applied sequence. For properly working devices the finite volume analysis showed only tolerable heating during MRI investigations in most cases. Only resonators transforming a few hundred mW into heat may reach temperature increases over 5 K. This requires resonators with volumes of several ten cubic centimeters, short inductor circuit paths with only a few 10 cm and a quality factor above ten. Using MR sequences, for which the MRI

Predictors of changes in health status between and within patients 12 months post left ventricular assist device implantation

DEFF Research Database (Denmark)

Brouwers, Corline; de Jonge, Nicolaas; Caliskan, Kadir

2014-01-01

improvements in health status between baseline and 3 months follow-up as assessed by the KCCQ (clinical summary score: F = 33.49, P physical component score: F = 31.59, P ... 3 months and 12 months follow-up (P > 0.05 for all). Higher scores on anxiety and depression over time, older age, lower ejection fraction, and more co-morbidity were associated with poorer health status scores on one or both of the KCCQ and SF-12 subscales. The majority of the between......BACKGROUND: Improving patient-reported outcomes (e.g. health status) has become an important goal in left ventricular assist device (LVAD) therapy, in addition to reducing mortality and morbidity. We examined predictors of changes in health status scores between and within patients 12 months post...

Association between cell-derived microparticles and adverse events in patients with nonpulsatile left ventricular assist devices.

Science.gov (United States)

Nascimbene, Angelo; Hernandez, Ruben; George, Joggy K; Parker, Anita; Bergeron, Angela L; Pradhan, Subhashree; Vijayan, K Vinod; Civitello, Andrew; Simpson, Leo; Nawrot, Maria; Lee, Vei-Vei; Mallidi, Hari R; Delgado, Reynolds M; Dong, Jing Fei; Frazier, O H

2014-05-01

Continuous-flow left ventricular assist devices (LVADs) expose blood cells to high shear stress, potentially resulting in the production of microparticles that express phosphatidylserine (PS+) and promote coagulation and inflammation. In this prospective study, we attempted to determine whether PS+ microparticle levels correlate with clinical outcomes in LVAD-supported patients. We enrolled 20 patients undergoing implantation of the HeartMate II LVAD (Thoratec Corp, Pleasanton, CA) and 10 healthy controls who provided reference values for the microparticle assays. Plasma was collected before LVAD implantation, at discharge, at the 3-month follow-up, and when an adverse clinical event occurred. We quantified PS+ microparticles in the plasma using flow cytometry. During the study period, 8 patients developed adverse clinical events: ventricular tachycardia storm in 1, non-ST-elevation myocardial infarction in 2, arterial thrombosis in 2, gastrointestinal bleeding in 2, and stroke in 3. Levels of PS+ microparticles were higher in patients at baseline than in healthy controls (2.11% ± 1.26% vs 0.69% ± 0.46%, p = 0.007). After LVAD implantation, patient PS+ microparticle levels increased to 2.39% ± 1.22% at discharge and then leveled to 1.97% ± 1.25% at the 3-month follow-up. Importantly, levels of PS+ microparticles were significantly higher in patients who developed an adverse event than in patients with no events (3.82% ± 1.17% vs 1.57% ± 0.59%, p microparticle levels may be associated with adverse clinical events. Thus, measuring PS+ microparticle levels in LVAD-supported patients may help identify patients at increased risk for adverse events. Copyright © 2014 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

21 CFR 872.3630 - Endosseous dental implant abutment.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Endosseous dental implant abutment. 872.3630... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Prosthetic Devices § 872.3630 Endosseous dental implant abutment. (a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component...

Implantation of venous access devices under local anesthesia: patients’ satisfaction with oral lorazepam

Directory of Open Access Journals (Sweden)

Chang DH

2015-07-01

Full Text Available De-Hua Chang,1 Sonja Hiss,1 Lena Herich,2 Ingrid Becker,2 Kamal Mammadov,1 Mareike Franke,1 Anastasios Mpotsaris,1 Robert Kleinert,3 Thorsten Persigehl,1 David Maintz,1 Christopher Bangard1 1Department of Radiology, 2Institute of Medical Statistics, Informatics and Epidemiology, 3Department of Surgery, University Hospital of Cologne, Cologne, Germany Objective: The aim of the study reported here was to evaluate patients’ satisfaction with implantation of venous access devices under local anesthesia (LA with and without additional oral sedation.Materials and methods: A total of 77 patients were enrolled in the prospective descriptive study over a period of 6 months. Subcutaneous implantable venous access devices through the subclavian vein were routinely implanted under LA. Patients were offered an additional oral sedative (lorazepam before each procedure. The level of anxiety/tension, the intensity of pain, and patients’ satisfaction were evaluated before and immediately after the procedure using a visual analog scale (ranging from 0 to 10 with a standardized questionnaire.Results: Patients’ satisfaction with the procedure was high (mean: 1.3±2.0 with no significant difference between the group with premedication and the group with LA alone (P=0.54. However, seven out of 30 patients (23.3% in the group that received premedication would not undergo the same procedure without general anesthesia. There was no significant influence of lorazepam on the intensity of pain (P=0.88. In 12 out of 30 patients (40% in the premedication group, the level of tension was higher than 5 on the visual analog scale during the procedure. In 21 out of 77 patients (27.3%, the estimate of the level of tension differed between the interventionist and the patient by 3 or more points in 21 out of 77 patients (27.3%.Conclusion: Overall patient satisfaction is high for implantation of venous access devices under LA. A combination of LA with lorazepam administered

Ion implantation for semiconductors

International Nuclear Information System (INIS)

Grey-Morgan, T.

1995-01-01

Full text: Over the past two decades, thousands of particle accelerators have been used to implant foreign atoms like boron, phosphorus and arsenic into silicon crystal wafers to produce special embedded layers for manufacturing semiconductor devices. Depending on the device required, the atomic species, the depth of implant and doping levels are the main parameters for the implantation process; the selection and parameter control is totally automated. The depth of the implant, usually less than 1 micron, is determined by the ion energy, which can be varied between 2 and 600 keV. The ion beam is extracted from a Freeman or Bernas type ion source and accelerated to 60 keV before mass analysis. For higher beam energies postacceleration is applied up to 200 keV and even higher energies can be achieved by mass selecting multiplycharged ions, but with a corresponding reduction in beam output. Depending on the device to be manufactured, doping levels can range from 10 10 to 10 15 atoms/cm 2 and are controlled by implanter beam currents in the range up to 30mA; continuous process monitoring ensures uniformity across the wafer of better than 1 % . As semiconductor devices get smaller, additional sophistication is required in the design of the implanter. The silicon wafers charge electrically during implantation and this charge must be dissipated continuously to reduce the electrical stress in the device and avoid destructive electrical breakdown. Electron flood guns produce low energy electrons (below 10 electronvolts) to neutralize positive charge buildup and implanter design must ensure minimum contamination by other isotopic species and ensure low internal sputter rates. The pace of technology in the semiconductor industry is such that implanters are being built now for 256 Megabit circuits but which are only likely to be widely available five years from now. Several specialist companies manufacture implanter systems, each costing around US$5 million, depending on the

Neutrophil Responses to Sterile Implant Materials.

Directory of Open Access Journals (Sweden)

Siddharth Jhunjhunwala

Full Text Available In vivo implantation of sterile materials and devices results in a foreign body immune response leading to fibrosis of implanted material. Neutrophils, one of the first immune cells to be recruited to implantation sites, have been suggested to contribute to the establishment of the inflammatory microenvironment that initiates the fibrotic response. However, the precise numbers and roles of neutrophils in response to implanted devices remains unclear. Using a mouse model of peritoneal microcapsule implantation, we show 30-500 fold increased neutrophil presence in the peritoneal exudates in response to implants. We demonstrate that these neutrophils secrete increased amounts of a variety of inflammatory cytokines and chemokines. Further, we observe that they participate in the foreign body response through the formation of neutrophil extracellular traps (NETs on implant surfaces. Our results provide new insight into neutrophil function during a foreign body response to peritoneal implants which has implications for the development of biologically compatible medical devices.

Stroke rehabilitation: assistive technology devices and environmental modifications following primary rehabilitation in hospital--a therapeutic perspective

DEFF Research Database (Denmark)

Sørensen, Hanne Vinkel; Lendal, Susie; Schultz-Larsen, Kirsten

2003-01-01

The aim of this article is to describe the need for assistive devices and environmental modifications among long-living stroke survivors and to investigate if the need is continued and growing over time. The study sample of 155 consecutive stroke patients with stroke-related impairment, discharged...... home from three hospitals in Copenhagen from 1996 through 1998, constituted 20% of the total population of stroke survivors in this area. The results showed that 75% of these patients were provided with assistive devices and/or environmental modifications at discharge. Six months after discharge...... be required in order to target stroke survivors' changing needs for assistive devices and environmental modifications....

A prospective study evaluating cochlear implant management skills: development and validation of the Cochlear Implant Management Skills survey.

Science.gov (United States)

Bennett, R J; Jayakody, D M P; Eikelboom, R H; Taljaard, D S; Atlas, M D

2016-02-01

To investigate the ability of cochlear implant (CI) recipients to physically handle and care for their hearing implant device(s) and to identify factors that may influence skills. To assess device management skills, a clinical survey was developed and validated on a clinical cohort of CI recipients. Survey development and validation. A prospective convenience cohort design study. Specialist hearing implant clinic. Forty-nine post-lingually deafened, adult CI recipients, at least 12 months postoperative. Survey test-retest reliability, interobserver reliability and responsiveness. Correlations between management skills and participant demographic, audiometric, clinical outcomes and device factors. The Cochlear Implant Management Skills survey was developed, demonstrating high test-retest reliability (0.878), interobserver reliability (0.972) and responsiveness to intervention (skills training) [t(20) = -3.913, P = 0.001]. Cochlear Implant Management Skills survey scores range from 54.69% to 100% (mean: 83.45%, sd: 12.47). No associations were found between handling skills and participant factors. This is the first study to demonstrate a range in cochlear implant device handling skills in CI recipients and offers clinicians and researchers a tool to systematically and objectively identify shortcomings in CI recipients' device handling skills. © 2015 John Wiley & Sons Ltd.

Anesthesia management for MitraClip device implantation

Directory of Open Access Journals (Sweden)

Harikrishnan Kothandan

2014-01-01

Full Text Available Aims and Objectives: Percutaneous MitraClip implantation has been demonstrated as an alternative procedure in high-risk patients with symptomatic severe mitral regurgitation (MR who are not suitable (or denied mitral valve repair/replacement due to excessive co morbidity. The MitraClip implantation was performed under general anesthesia and with 3-dimensional transesophageal echocardiography (TEE and fluoroscopic guidance. Materials and Methods: Peri-operative patient data were extracted from the electronic and paper medical records of 21 patients who underwent MitraClip implantations. Results: Four MitraClip implantation were performed in the catheterization laboratory; remaining 17 were performed in the hybrid operating theatre. In 2 patients, procedure was aborted, in one due to migration of the Chiari network into the left atrium and in second one, the leaflets and chords of the mitral valve torn during clipping resulting in consideration for open surgery. In the remaining 19 patients, MitraClip was implanted and the patients showed acute reduction of severe MR to mild-moderate MR. All the patients had invasive blood pressure monitoring and the initial six patients had central venous catheterization prior to the procedure. Intravenous heparin was administered after the guiding catheter was introduced through the inter-atrial septum and activated clotting time was maintained beyond 250 s throughout the procedure. Protamine was administered at the end of the procedure. All the patients were monitored in the intensive care unit after the procedure. Conclusions: Percutaneous MitraClip implantation is a feasible alternative in high-risk patients with symptomatic severe MR. Anesthesia management requirements are similar to open surgical mitral valve repair or replacement. TEE plays a vital role during the MitraClip implantation.

Challenges facing academic research in commercializing event-detector implantable devices for an in-vivo biomedical subcutaneous device for biomedical analysis

Science.gov (United States)

Juanola-Feliu, E.; Colomer-Farrarons, J.; Miribel-Català, P.; Samitier, J.; Valls-Pasola, J.

2011-05-01

It is widely recognized that the welfare of the most advanced economies is at risk, and that the only way to tackle this situation is by controlling the knowledge economies and dealing with. To achieve this ambitious goal, we need to improve the performance of each dimension in the "knowledge triangle": education, research and innovation. Indeed, recent findings point to the importance of strategies of adding-value and marketing during R+D processes so as to bridge the gap between the laboratory and the market and so ensure the successful commercialization of new technology-based products. Moreover, in a global economy in which conventional manufacturing is dominated by developing economies, the future of industry in the most advanced economies must rely on its ability to innovate in those high-tech activities that can offer a differential added-value, rather than on improving existing technologies and products. It seems quite clear, therefore, that the combination of health (medicine) and nanotechnology in a new biomedical device is very capable of meeting these requisites. This work propose a generic CMOS Front-End Self-Powered In-Vivo Implantable Biomedical Device, based on a threeelectrode amperometric biosensor approach, capable of detecting threshold values for targeted concentrations of pathogens, ions, oxygen concentration, etc. Given the speed with which diabetes can spread, as diabetes is the fastest growing disease in the world, the nano-enabled implantable device for in-vivo biomedical analysis needs to be introduced into the global diabetes care devices market. In the case of glucose monitoring, the detection of a threshold decrease in the glucose level it is mandatory to avoid critic situations like the hypoglycemia. Although the case study reported in this paper is complex because it involves multiple organizations and sources of data, it contributes to extend experience to the best practices and models on nanotechnology applications and

[Electromagnetic interference in the current era of cardiac implantable electronic devices designed for magnetic resonance environment].

Science.gov (United States)

Ribatti, Valentina; Santini, Luca; Forleo, Giovanni B; Della Rocca, Domenico; Panattoni, Germana; Scali, Marta; Schirripa, Valentina; Danisi, Nicola; Ammirati, Fabrizio; Santini, Massimo

2017-04-01

In the last decades we are observing a continuous increase in the number of patients wearing cardiac implantable electronic devices (CIEDs). At the same time, we face daily with a domestic and public environment featured more and more by the presence and the utilization of new emitters and finally, more medical procedures are based on electromagnetic fields as well. Therefore, the topic of the interaction of devices with electromagnetic interference (EMI) is increasingly a real and actual problem.In the medical environment most attention is paid to magnetic resonance, nevertheless the risk of interaction is present also with ionizing radiation, electrical nerve stimulation and electrosurgery. In the non-medical environment, most studies reported in the literature focused on mobile phones, metal detectors, as well as on headphones or digital players as potential EMI sources, but many other instruments and tools may be intentional or non-intentional sources of electromagnetic fields.CIED manufacturers are more and more focusing on new technological features in order to make implantable devices less susceptible to EMI. However, patients and emitter manufacturers should be aware that limitations exist and that there is not complete immunity to EMI.

Preoperative Right-Sided Cardiac Congestion Is Associated with Gastrointestinal Bleeding in Patients with Continuous-Flow Left Ventricular Assist Devices.

Science.gov (United States)

Tomizawa, Yutaka; Tanaka, Akiko; Kitahara, Hiroto; Sakuraba, Atsushi; Uriel, Nir; Jeevanandam, Valluvan; Ota, Takeyoshi

2018-06-01