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: 6341374
• 负责人: WILLIAM A SMITH
• 金额: $ 197.04万
• 依托单位: CLEVELAND CLINIC FOUNDATION
• 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/6341374
• 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（逐字摘自申请人摘要）：该项目的基本目标 拟议的计划是使一种新的药物达到临床准备状态 电动、完全植入式 TAH，基于 Magscrew 致动器 和生物化血泵。实现这一目标的具体目标是：（一） 设计和开发技术先进、故障安全的电子控制单元 （ECU），它将在电力故障后维持患者的生命， 直至进行维护。 ECU 还包含硬件和患者 监控能力和遥测功能。 (2) 构建和测试精细化 其余系统组件的版本，基于当前的技术水平 技术。 (3) 将组件集成为功能完整的系统。 （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。 (6) 进行台架耐久试验。 (7) 按照 FDA 设计控制条例完成这项工作。 作为这种设计和测试工作的结果，外科医生将有另一种， 相对有限的 TAH 替代方案中的最佳选择。 “生物化”泵 Magscrew 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 尽管没有抗凝治疗，犊牛仍发生血栓栓塞。在 此外，磁螺杆执行器是概念上最简单且最坚固的 这些可用于 TAH，接触或摩擦表面很少。 机械故障的可能来源很少，这明显增加了 可靠性和长期耐用性。 “故障安全”控制器将 解决残留的压线、腐蚀的焊点、软件挂起和 即使有最好的基础设计，类似的问题也是不可避免的， 和严格的质量控制，在复杂、密集的电子产品中 被植入敌对环境中，并导致其他故障， 较旧的系统。虽然 TAH 的临床需求一直被估计为 比 VAD 小得多，它在全国范围内都具有规模 在国际上具有商业意义。在美国，可能会 每年潜在销售额超过 10 亿美元。 TAH市场将支持多个 供应商，即使没有现在那么多的供应商进军 VAD 市场。对于那些 需要 TAH，替代品的供应可能非常有限 字面上的生死意义。