MAGSCREW ACUTATOR FOR VAD AND TAH PUMPS--PHASE II

根据国家卫生研究院提供的第一阶段SBIR拨款， 机械技术公司(MTL)已成功 展示了一种创新的磁力螺丝技术 可能用于全人工心脏的(磁螺杆)致动器 (TAH)由克利夫兰临床基金会(CCF)开发。 因此，该阶段II应用描述了联合MTI/CCF 计划将磁螺杆执行器的设计提升到 完全集成的TAH子系统。此外，四个TAH系统将 可同时支持体外和体内试验。尽管 心脏病防治取得重大进展， 心力衰竭仍然是美国人死亡的主要原因 各州。还有许多患者因心脏功能低下而丧失工作能力。 输出。1991年，医学研究所发表了一份报告 强烈支持继续人工心脏研究工作。它 MTI/CCF的这种社会需求和商业机会 团队将解决下一代执行器的问题，该执行器可适应这两种情况 心脏辅助和心脏置换设备。的最终目标是 这项研究旨在获得FDA的批准，将CCF/MTI TAH用于 研究临床试验，并随后获得充分的 监管部门批准将其作为临床产品使用。 建议的商业应用磁螺杆执行器将是一种 使能子系统(就商业上可接受的寿命和 可靠性)，用于心脏辅助装置(VAD)和 永久植入型TAH。根据1991年发布的一份报告， 医学研究所，可能有35,000到70,000名初级学生 每年一次的机械循环支持系统候选人 (MCSS)到2010年。虽然大多数人都需要VAD，但多达 10,000到20,000个案例可能证明使用TAH是合理的。到2020年， 参加中学文凭考试的学生可能多达20万人。 这些估计假设至少有一个批准的VAD可用 到1999年，并且至少有一个批准的TAH 15可在 21世纪初

Under a Phase I SBIR grant from the National Institutes Of Health, Mechanical Technology Incorporated (MTl) has successfully demonstrated the technology of an innovative magnetic Screw (magscrew) actuator for possible use in a total artificial heart (TAH) developed by the Cleveland Clinic Foundation (CCf). Accordingly, this Phase II application describes a joint MTI/CCF program to advance the magscrew actuator design to the level of a fully Integrated TAH subsystem. Additionally, four TAH systems will be built to support both in vitro and in vivo testing. Despite great progress in the prevention and treatment of heart disease, cardiac failure remains the leading cause of death in the United States. Many additional patients are Incapacitated by low cardiac output. In 1991, the Institute of Medicine published a report strongly endorsing continued work on artificial heart research. lt is this social need and commercial opportunity that the MTI/CCF team will address with a next-generation actuator adaptable to both heart assist and heart replacement devices. The ultimate goal of this research is to obtain FDA approval to use the CCF/MTI TAH for investigational clinical trials, and to subsequently gain full regulatory approval to make it available as a clinical product. PROPOSED COMMERCIAL APPLICATIONS The magscrew actuator will be an enabling subsystem (in terms of commercially acceptable life and reliability) for both ventricular assist devices (VADs) and the permanent implantable TAH. According to a 1991 report published by the Institute Of Medicine, there could be 35,000 to 70,000 primary candidates annually for mechanical Circulatory support systems (MCSSs) by year 2010. While most would require VADs, as many as 10,000 to 20,000 cases may justify the use of a TAH. By year 2020, there may be as many as 200,000 secondary candidates for MCSSs. These estimates assume that at least one approved VAD is available by 1999, and that at least one approved TAH 15 available in the early 2000s