Development of a Magnetically Driven Heart Pump

磁力驱动心脏泵的开发

• 批准号: 7326902
• 负责人: KURT A DASSE
• 金额: $ 80.39万
• 依托单位: THORATEC, LLC
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-09-30 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7326902
• 关键词: Accounting; Acute; Address; Adolescent; Adult; Advisory Committees; Affect; Aneurysm; Animal Testing; Animals; Arrhythmia; Autopsy; Biological Assay; Blood; Blood Cells; Blood flow; Cannulas; Cardiac; Cardiovascular Diseases; Cardiovascular system; Characteristics; Child; Child Care; Child Support; Childhood; Chronic; Clinical; Clinical Protocols; Clinical Trials; Condition; Congenital Abnormality; Congenital Heart Defects; Congestive Heart Failure; Coronary artery; Custom; Development; Devices; Dilated Cardiomyopathy; Failure; Fibrinogen; Fostering; Functional disorder; Future; Goals; Heart; Heart Diseases; Heart Transplantation; Heart failure; Hemoglobin; Implant; Implantation procedure; In Vitro; Infant; Institutes; Lead; Left; Life; Lung; Measures; Mechanics; Modeling; Motor; Myocardial Infarction; Numbers; Operative Surgical Procedures; Organ; Patients; Pediatric Hospitals; Performance; Phase; Physiological; Plasma; Population; Positioning Attribute; Production; Property; Public Health; Pump; Recovery; Reporting; Research; Research Personnel; Research Priority; Risk; Route; Safety; Series; Sheep; Simulate; Site; Staging; System; Technology; Testing; Therapeutic; Thromboembolism; Thrombosis; Thrombus; Trauma; United States; United States Food and Drug Administration; Universities; Validation; Ventricular; Week; Work; biomaterial compatibility; blood pump; day; design; efficacy trial; experience; hemodynamics; improved; in vivo; in vivo Model; malformation; neonate; novel; novel therapeutics; patient safety; pre-clinical; pressure; programs; research clinical testing; research study; seal; sham surgery; statistics; success; ventricular assist device

DESCRIPTION (provided by applicant): The objective of this work is to transition the development of a ventricular assist system designed to support neonates and small children from animal testing into a single center clinical trial. The 2001 report of the NHLBI) sponsored Task Force on Research in Pediatric Cardiovascular Disease identified the pressing need for novel systems to support children severely compromised by congenital cardiovascular malformations, cardiomyopathies, congestive heart failure, arrhythmias, myocardial infarctions and coronary artery aneurysms. The pediatric ventricular assist device under development by Levitronix and its development partner the University of Pittsburgh (UOP) is intended to fulfill the need for acute and temporary cardiac life support (up to 4 weeks) in infants and small children. Our goal will be to extend technology associated with a small-scale paracorporeal MagLev centrifugal blood pump, to create a clinical product for infants and small children. Uniquely, this pump has no seals, bearings or other movable parts that are traditionally associated with thrombus formation or mechanical failure. In Phase I of the project, we demonstrated the soundness of this technology for the pediatric application through a series of in vitro and in vivo experiments. In Phase II of the project, we optimized pump design to accommodate the hemodynamic conditions typical for the pediatric patient and demonstrated effective hemodynamic performance and biocompatibility in a series of in vivo implants simulating clinically realistic conditions. Acknowledging the importance and clinical need of advancing this technology rapidly into the clinical arena, we propose here a Phase II Continuation to support the completion of the hardware development to its final clinical form, performance of the final series of pre-clinical animal testing using the clinical-form hardware; and, the initiation of clinical trials. Our specific Aims include: Aim 1: Characterize the in vitro hemodynamic properties and hemocompatibility of Levitronix pediatric VAD-cannula system (PediVAS). Aim 2: Determine PediVAS function and biocompatibility in the juvenile ovine model. Aim 3. Conduct preliminary clinical safety and efficacy trials of the Levitronix PediVAS in infants and children with heart failure. In achieving these goals, these results will lead to a novel therapeutic opportunity to improve the care of children with congenital and/or acquired cardiac defects. By achieving the above specific aims, we intend to fabricate fully verified and validated hardware, establish component reliability, and conduct a pilot phase clinical trial. Levitronix has substantial experience in fabricating clinical-use blood pump hardware and meeting regulatory requirements for clinical trial testing. The University of Pittsburgh and Children's Hospital have more than 20 years of experience in the clinical testing and validation of ventricular assist devices for adult and pediatric patients. The research team, consisting of Levitronix and University of Pittsburgh, is thus positioned to conduct the first FDA approved clinical trial of a pediatric VAD. If successful, these results will lead to a novel therapeutic option for the care of children with congenital and/or acquired cardiac defects. 7. Project Narrative The PediVAS system is being developed to address the need to support children with severely compromised heart conditions. The pediatric ventricular assist device is intended to fulfill the need for acute and temporary cardiac life support (up to 4 weeks) in infants and small children.

描述（由申请人提供）：这项工作的目的是将旨在支持新生儿和幼儿的心室辅助系统的开发从动物试验转变为单中心临床试验。 NHLBI 资助的小儿心血管疾病研究工作组的 2001 年报告指出，迫切需要新的系统来支持患有先天性心血管畸形、心肌病、充血性心力衰竭、心律失常、心肌梗死和冠状动脉瘤的儿童。 Levitronix 及其开发合作伙伴匹兹堡大学 (UOP) 正在开发的儿科心室辅助装置旨在满足婴儿和幼儿的急性和临时心脏生命支持（长达 4 周）的需求。我们的目标是扩展与小型体外 MagLev 离心血泵相关的技术，为婴儿和幼儿创造临床产品。独特的是，该泵没有传统上与血栓形成或机械故障相关的密封件、轴承或其他可移动部件。在该项目的第一阶段，我们通过一系列体外和体内实验证明了该技术在儿科应用的可靠性。在该项目的第二阶段，我们优化了泵设计，以适应儿科患者的典型血流动力学条件，并在一系列模拟临床真实条件的体内植入物中展示了有效的血流动力学性能和生物相容性。认识到将这项技术迅速推向临床领域的重要性和临床需求，我们在此提出第二阶段延续，以支持完成最终临床形式的硬件开发、使用临床形式的硬件；以及，启动临床试验。我们的具体目标包括： 目标 1：表征 Levitronix 儿科 VAD 插管系统 (PediVAS) 的体外血流动力学特性和血液相容性。目标 2：确定幼年绵羊模型中的 PediVAS 功能和生物相容性。目标 3. 对患有心力衰竭的婴儿和儿童进行 Levitronix PediVAS 的初步临床安全性和有效性试验。在实现这些目标的过程中，这些结果将带来新的治疗机会，以改善患有先天性和/或后天性心脏缺陷的儿童的护理。通过实现上述具体目标，我们打算制造经过充分验证和验证的硬件，建立组件可靠性，并进行试点阶段临床试验。 Levitronix 在制造临床用血泵硬件和满足临床试验测试的监管要求方面拥有丰富的经验。匹兹堡大学和儿童医院在成人和儿童患者心室辅助装置的临床测试和验证方面拥有 20 多年的经验。因此，由 Levitronix 和匹兹堡大学组成的研究团队有望开展 FDA 批准的首个儿科 VAD 临床试验。如果成功，这些结果将为患有先天性和/或后天性心脏缺陷的儿童提供一种新的治疗选择。 7. 项目叙述 PediVAS 系统的开发是为了满足支持患有严重心脏病的儿童的需要。儿科心室辅助装置旨在满足婴儿和幼儿的急性和临时心脏生命支持（最长 4 周）的需求。