Development of a Magnetically Driven Heart Pump

磁力驱动心脏泵的开发

• 批准号: 7016350
• 负责人: KURT A DASSE
• 金额: $ 55.58万
• 依托单位: THORATEC, LLC
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-07-01 至 2007-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7016350
• 关键词: auxiliary heart prosthesis; bioengineering /biomedical engineering; biomagnetism; biomaterial compatibility; biomedical equipment development; biomedical equipment safety; circulatory assist; clinical biomedical equipment; consumable /disposable biomedical equipment; extracorporeal circulation; health economics; heart failure; hemodynamics; miniature biomedical equipment; newborn animals; pediatrics; sheep

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.

该第二阶段提案旨在解决心力衰竭儿童对机械循环支持的未满足需求。儿童心脏病患者具有一些独特的特征，例如体型较小、血容量减少和血流动力学特性改变，这些特征使他们与患有心力衰竭的成人区分开来。我们试图通过开发一种微型、低成本、离心心室辅助装置来解释这些特征，该装置用作体外 机械支撑系统。我们的方法采用磁悬浮、无摩擦的转子/定子配置，可有效产生流量，同时最大限度地减少溶血。当前设计的主要优点是其体积小且相对简单的体外设计、能够在大范围的流量条件下有效调节泵输出以及易于生产。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，并在临床试验之前启动设备准备测试。我们认为，非常需要开发一种小型、廉价的泵，它需要最小的启动量，并且不需要密封件和轴承。该提案的具体目标是： 1）优化泵和插管设计，以满足儿童的心脏支持需求。 2）针对儿科操作条件完善驱动控制台的设计。 3）对电机、泵、驱动控制台进行可靠性测试。 4) 展示体内血流动力学性能和生物相容性。我们相信，我们的技术可以通过小型一次性装置提供有效的左心室辅助 设备将为患有严重心脏病的儿童的健康提供所需的好处，同时不会显着增加这些患者的护理成本。实现该 II 期计划提出的目标将验证 Levitronix 儿科心室辅助装置的安全性和适用性，以便在 IDE 临床试验下进行评估，该临床试验将在 III 期计划中进行。我们预计在项目三期，我们将满足监管要求 管理 IDE、制造经过验证和验证的硬件、建立可靠性并进行指定的临床试验。