MAGSCREW ACUTATOR FOR VAD AND TAH PUMPS--PHASE II

根据美国国立卫生研究院的第一阶段SBIR赠款， 机械技术公司（MTl）已成功地 展示了一种创新的磁性螺丝技术 可用于全人工心脏的（磁螺旋）致动器 (TAH)克利夫兰临床基金会（Cleveland Clinic Foundation，CCF） 因此，本第二阶段申请描述了一个联合MTI/CCF 程序，以推进磁螺旋致动器设计的水平， 完全集成的天阿子系统。此外，四个天阿系统将 支持体外和体内测试。尽管 心脏病的防治取得了很大进展， 心力衰竭仍然是美国人死亡的主要原因 States.许多其他患者因低心功能而丧失能力。 输出. 1991年，医学研究所发表了一份报告， 强烈支持继续进行人工心脏研究。Lt 正是这种社会需求和商业机会， 团队将使用下一代致动器解决这两个问题， 心脏辅助和心脏置换装置。的最终目标 这项研究是为了获得FDA批准，将CCF/MTI TAH用于 研究性临床试验，并随后获得全面 监管部门批准，使其可作为临床产品。 建议的商业应用磁螺旋致动器将是一个 使能子系统（就商业上可接受的寿命而言， 心室辅助装置（VAD）和 永久性植入式TAH。根据1991年出版的一份报告， 在医学研究所，可能有35，000到70，000名初级 循环支持系统的候选人 （2010年）。虽然大多数需要VAD，但 10，000至20，000例病例可证明使用TAH是合理的。到2020年， 可能有多达200，000个MCSS的二级候选人。 这些估计假设至少有一个批准的VAD可用 到1999年，至少有一个批准的TAH 15可在 2000年代初

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