Development of a Magnetically Driven Heart Pump

描述（由申请人提供）：这项工作的目的是将心室辅助系统的开发从动物试验过渡到单中心临床试验，该系统旨在支持新生儿和幼儿。由NHLBI赞助的儿童心血管疾病研究特别小组2001年的报告指出，迫切需要新的系统来支持严重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。由Levitronix及其开发合作伙伴匹兹堡大学（UOP）开发的儿科心室辅助装置旨在满足婴幼儿急性和临时心脏生命支持（长达4周）的需求。我们的目标将是扩展与小型仿肉体磁悬浮离心血泵相关的技术，为婴儿和儿童创造一种临床产品。独特的是，这种泵没有密封，轴承或其他传统上与血栓形成或机械故障相关的可移动部件。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合理性。在二期项目中，我们优化了泵的设计，以适应儿科患者典型的血液动力学条件，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液动力学性能和生物相容性。认识到将这项技术快速推进到临床领域的重要性和临床需求，我们在这里提出一个II期延续，以支持硬件开发到最终临床形式的完成，以及使用临床形式硬件的最后一系列临床前动物试验的性能；临床试验的开始。我们的具体目标包括：目标1：表征Levitronix儿童vad -插管系统（PediVAS）的体外血液动力学特性和血液相容性。目的2：确定PediVAS在幼羊模型中的功能和生物相容性。目标3。开展Levitronix PediVAS在心力衰竭婴儿和儿童中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，这些结果将为改善先天性和/或获得性心脏缺陷儿童的护理带来新的治疗机会。通过实现上述特定目标，我们打算制造完全经过验证和验证的硬件，建立组件可靠性，并进行中试阶段的临床试验。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有超过20年的经验。因此，由Levitronix和匹兹堡大学组成的研究团队将进行第一个FDA批准的儿科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提供一种新的治疗选择。7. PediVAS系统的开发是为了满足对患有严重心脏病的儿童的支持需求。小儿心室辅助装置旨在满足婴幼儿急性和临时心脏生命支持（长达4周）的需要。

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.