Development of a Magnetically Driven Heart Pump

该II期提案旨在解决心力衰竭儿童机械循环支持的未满足需求。小儿心脏病患者具有几个独特的特征，如体型小，血容量减少，血流动力学特性改变，这些特征将其与成人心力衰竭区分开来。我们试图通过开发一种微型、低成本、离心式心室辅助装置来解释这些特征， 机械支持系统我们的方法具有磁悬浮，因此摩擦少，转子/定子配置，有效地产生流量，最小的溶血。当前设计的主要优点是其体积小且相对简单的体外设计、其在大范围流量条件下有效调节泵输出的能力以及其易于生产。在第一阶段测试中，Levitronix与匹兹堡大学合作，通过一系列成功的体外和体内实验证明了该技术在儿科应用中的可靠性。在第二阶段，我们打算完成产品的设计和验证，并在预期的临床试验中启动设备准备测试。我们认为，开发一种小型、廉价的泵是非常可取的，这种泵需要最小的灌注量，并且消除了密封件和轴承。本建议的具体目标是：1）优化泵和插管的设计，以满足儿童的心脏支持需求。2)完善儿科操作条件下的驱动控制台设计。3)对电机、泵和驱动控制台进行可靠性测试。4)证明体内血流动力学性能和生物相容性。我们相信，我们的技术，它提供了有效的左心室援助与一个小的，一次性的， 该设备将为患有严重心脏病的儿童的健康提供所需的益处，同时不会显著增加护理这些患者的成本。实现本II期项目中提出的目标将确认Levitronix小儿心室辅助装置的安全性和适用性，以在IDE临床试验中进行评价，该临床试验将在III期项目中进行。我们预计，在项目的第三阶段，我们将满足监管要求 管理IDE，制造经过验证和确认的硬件，建立可靠性，并进行指定的临床试验。

This Phase II proposal seeks to address an unmet need for mechanical circulatory support in children with heart failure. Pediatric heart patients possess several unique features, such as small body size, reduced blood volume, and altered hemodynamic properties, which distinguish them from adults with heart failure. We have sought to account for these features by developing a miniature, low-cost, centrifugal ventricular assist device for use as an extracorporeal mechanical support system. Our approach features a magnetically levitated, and thus friction-less, rotor/stator configuration, which efficiently generates flow, with minimum hemolysis. The major advantages of the current design are its small and relatively simple extracorporeal design, its ability to efficiently regulate pump output over a large range of flow conditions, and its ease of production. In Phase I testing, Levitronix, in collaboration with the University of Pittsburgh, demonstrated the soundness of this technology for the pediatric application through a series of successful in vitro and in vivo experiments. In Phase II we intend to complete the design and validation of the product, and to launch device readiness testing in anticipation of clinical trials. We contend that the development of a small, inexpensive pump, which requires a minimal priming volume, and which eliminates seals and bearings, is highly desirable. The specific aims of this proposal are: 1) To optimize pump and cannulae design to meet the cardiac support requirements of children. 2) To refine the design of the drive console for pediatric operating conditions. 3) Conduct reliability testing of motors, pumps, and drive consoles. 4) Demonstrate hemodynamic performance and biocompatibility in vivo. We believe that our technology, which provides effective left ventricular assistance with a small, disposable device, will provide needed benefits to the health of children with severe cardiac disease, while not adding significantly to cost of caring for these patients. Achieving the aims proposed in this Phase II program will validate the safety and suitability of the Levitronix pediatric ventricular assist device for evaluation under an IDE clinical trial, which will be carried out in a Phase III program. We project that in Phase III of the project, we will meet the regulatory requirements governing an IDE, fabricate verified and validated hardware, establish reliability, and conduct indicated clinical trials.