Magscrew TAH Testing thru Pre-Clinical Readiness

通过临床前准备进行磁螺杆 TAH 测试

• 批准号: 6658102
• 负责人: WILLIAM A SMITH
• 金额: $ 194.64万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-26 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6658102
• 关键词: auxiliary heart prosthesis; bioengineering /biomedical engineering; biomaterial compatibility; biomaterial interface interaction; biomedical equipment development; biomedical equipment safety; circulatory assist; clinical biomedical equipment; computer program /software; computer system design /evaluation; cow; electronic pacemaker; heart prosthesis; patient monitoring device; telemetry; tissue engineering

DESCRIPTION (Verbatim from Applicant's Abstract):The fundamental goal of the proposed program is to bring to the point of clinical readiness a new electrically powered, totally implantable TAH, based on the Magscrew actuator and the biolized blood pump. The specific aims to meet this goal are: (1) To design and develop an advanced technology, fail safe, electronic control unit (ECU), which will maintain the patient's life after an electrical failure, until maintenance is performed. The ECU also contains hardware and patient monitoring capability, and a telemetry function. (2) To build and test refined versions of the remaining system components, based on current state of the art technology. (3) To integrate the components into a functional, complete system. (4) To perform in-vivo performance tests, exercising system capabilities. (5) To perform in-vivo durability tests. (6) To perform bench endurance tests. (7) To complete this work in compliance with FDA Design Control Regulations. As a consequence of this design and testing effort, surgeons will have another, superior choice among relatively limited TAH alternatives. The "biolized" pump of the Magscrew TAH has pericardial valves combined with biological, protein blood contacting surfaces, and a long track record of extremely rare thrombo-embolic episodes in calves, despite the absence of anti-coagulation. In addition, the Magscrew actuator is the conceptually simplest and most rugged of those available for TAH's, with very few contacting or rubbing surfaces. Mechanical failures have very few possible sources, which clearly increases both reliability and long-term durability. The "fail safe" controller will address the residual pinched wire, corroded solder joint, software hang-up and similar problems that are unavoidable, even with the best fundamental design, and rigorous quality control, in sophisticated, densely packed electronics that are implanted in a hostile environment, and that have caused failures of other, older systems. While the clinical need for TAH's is consistently estimated to be much smaller than for VAD's, it is of a size both nationally and internationally to be of commercial significance. In the United States, it may exceed $1B per year in potential sales. The TAH market will support several suppliers, if not as many as now pursuing the VAD market. To those patients who will need a TAH, the potentially very limited supply of alternatives is of literally life and death significance.

描述(逐字摘自申请者摘要)： 拟议的计划是将临床准备工作带到一个新的点 基于磁螺杆执行器的电动、完全植入式TAH 还有生物血泵。实现这一目标的具体目标是：(1) 设计和开发一种技术先进、故障安全的电子控制单元 (ECU)，它将在电气故障后维持患者的生命， 直到执行维护为止。ECU还包含硬件和患者 监控功能和遥测功能。(2)建设和测试精细化 基于当前技术水平的其余系统组件的版本 技术(3)将组件集成到一个功能完整的系统中。 (4)进行体内性能测试，锻炼系统能力。(5) 进行体内耐久性测试。(六)进行长凳耐力试验。(7) 按照FDA的设计控制规定完成这项工作。 作为这种设计和测试工作的结果，外科医生将有另一个， 在相对有限的TAH替代方案中提供更好的选择。“生物化”泵 磁螺杆TAH的心包瓣膜与生物、蛋白质相结合 血液接触表面，以及极其罕见的长期记录 小牛出现血栓栓塞症，尽管没有抗凝。在……里面 此外，磁螺杆执行器是概念上最简单、最坚固的 适用于TAH，极少接触或摩擦表面。 机械故障的可能来源很少，这显然增加了 既可靠又经久耐用。“故障安全”控制器将 解决残余夹丝、焊点腐蚀、软件挂起和 类似的问题是不可避免的，即使是最好的基础设计， 和严格的质量控制，在复杂、密集封装的电子产品中 被植入到恶劣的环境中，并导致了其他， 较旧的系统。虽然对TAH的临床需求一直被估计为 比VAD要小得多，它的大小既有全国范围的，也有 国际上具有商业意义。在美国，它可能会 每年的潜在销售额超过10亿美元。TAH市场将支持几个 供应商，如果没有现在追求VAD市场的那么多的话。对于那些 将需要TAH，潜在的非常有限的替代供应是 字面上的生死意义。