Development of a Magnetically Driven Heart Pump

描述(由申请人提供)：这项工作的目标是将旨在支持新生儿和儿童的脑室辅助系统的开发从动物试验转变为单中心临床试验。2001年由NHLBI赞助的儿童心血管疾病研究特别工作组的报告指出，迫切需要新的系统来支持因先天性心血管畸形、心肌病、充血性心力衰竭、心律失常、心肌梗死和冠状动脉动脉瘤而严重受损的儿童。Levitronix及其开发合作伙伴匹兹堡大学(UOP)正在开发的儿科心脏辅助装置旨在满足婴幼儿对急性和临时性心脏生命支持(长达4周)的需求。我们的目标是扩展与小型准心脏磁悬浮离心式血泵相关的技术，为婴幼儿创造一种临床产品。独特的是，这种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。在项目的第一阶段，我们通过一系列的体外和体内实验证明了这项技术在儿科应用中的可靠性。在项目的第二阶段，我们优化了泵的设计，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现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进到临床领域的重要性和临床需要，我们建议在此继续进行第二阶段，以支持完成最终临床形式的硬件开发，使用临床形式硬件进行最后一系列临床前动物试验的性能，以及启动临床试验。我们的具体目标包括：目的1：研究利维替尼小儿VAD-插管系统(PediVAS)的体外血流动力学特性和血液相容性。目的：在幼年绵羊模型中测定儿科VAS的功能和生物相容性。目的3.对婴幼儿心力衰竭患者应用左旋硝酸钙的安全性和有效性进行初步临床试验。在实现这些目标的过程中，这些结果将带来一个新的治疗机会，改善先天性和/或获得性心脏缺陷儿童的护理。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，并进行试点阶段的临床试验。Levitronix在制造临床用血泵硬件和满足临床试验测试的法规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的心脏辅助设备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将进行FDA批准的第一个儿科VAD临床试验。如果成功，这些结果将为先天性和/或获得性心脏缺陷儿童的护理带来新的治疗选择。7.项目说明正在开发儿科辅助系统，以满足支持患有严重心脏疾病的儿童的需要。儿科心脏辅助装置旨在满足婴儿和儿童对急性和临时性心脏生命支持(长达4周)的需求。

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.