Magscrew TAH Testing thru Pre-Clinical Readiness

描述（来自申请人摘要的逐字）： 拟议的计划是把一个新的临床准备点， 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：（1） 设计和开发一个先进的技术，故障安全，电子控制单元 (ECU)，这将在电力故障后维持患者的生命， 直到进行维护。ECU还包含硬件和患者 监控能力和遥测功能。(2)构建和测试细化 基于当前技术水平的其余系统组件的版本 技术. (3)将各组件集成到一个功能齐全的系统中。 (4)执行体内性能测试，锻炼系统功能。（五） 进行体内耐久性试验。(6)进行台架耐久性试验。（七） 按照FDA设计控制法规完成本工作。 由于这种设计和测试的努力，外科医生将有另一个， 在相对有限的天阿替代品中的上级选择。“生物化”泵 Magscrew TAH的心包瓣膜结合了生物、蛋白质 血液接触表面，以及极其罕见的长期记录 尽管没有抗凝，小牛中仍发生血栓栓塞事件。在 此外，Magscrew致动器是概念上最简单和最坚固的 那些可用于TAH的，具有很少的接触或摩擦表面。 机械故障的可能来源非常少，这显然增加了 可靠性和长期耐用性。“故障安全”控制器将 解决残留的夹线、腐蚀的焊点、软件挂起和 类似的问题是不可避免的，即使有最好的基本设计， 和严格的质量控制，在复杂的，密集的电子产品， 被植入到一个充满敌意的环境中，并导致其他人的失败， 旧系统。尽管对TAH的临床需求一直被估计为 比VAD的小得多，它是一个国家的规模， 在国际上具有重要的商业意义。在美国， 年销售额超过10亿美元。天阿市场将支持几个 供应商，如果不像现在那么多追求VAD市场。对于那些 将需要TAH，替代品的供应可能非常有限， 生与死的意义

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.