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（逐字病申请人的摘要）： 拟议的计划将使临床准备就绪 基于Magscrew执行器，电力，完全可植入的TAH 和生物泵。实现此目标的具体目的是：（1） 设计和开发先进的技术，失败安全，电子控制单元 （ECU），将在电衰竭后维持患者的生活， 直到进行维护为止。 ECU还包含硬件和病人 监视功能和遥测功能。 （2）构建和测试完善 其余系统组件的版本，基于当前的最新技术状态 技术。 （3）将组件集成到功能，完整的系统中。 （4）执行体内性能测试，锻炼系统功能。 （5） 进行体内耐用性测试。 （6）执行基准耐力测试。 （7） 符合FDA设计控制法规，完成这项工作。 由于这种设计和测试工作，外科医生将有另一个 相对有限的TAH替代方案中的较高选择。 “生物化”泵 Magscrew Tah的心包瓣膜结合生物，蛋白质 血接触表面，以及极为罕见的长期记录 尽管没有抗凝凝结，但犊牛中的血管发作发作。在 此外，Magscrew执行器在概念上是最简单，最坚固的 那些可用于TAH的，几乎没有接触或摩擦表面。 机械故障几乎没有可能的来源，这显然增加了 可靠性和长期耐用性。 “故障安全”控制器将 解决剩余的捏电线，腐蚀的焊接接头，软件挂起和 类似的问题是不可避免的，即使有最佳的基本设计， 和严格的质量控制，以精致的，密集的电子设备为 被植入敌对的环境，并导致其他人的失败， 较旧的系统。虽然对TAH的临床需求始终估计 比VAD小得多，在全国范围内和 在国际上具有商业意义。在美国，它可能 每年的潜在销售额超过$ 1B。 TAH市场将支持几个 供应商，即使不是现在追求VAD市场的供应商。给那些患者 将需要一个tah，替代方案的潜在替代供应可能非常有限。 实际上，生死意义。