A Durable, Load-Bearing Muscle to Prothesis Coupling

描述（由申请人提供）：严重的心力衰竭每年导致10万美国人死亡。心脏移植是有效的，但稀缺;药物是可用的，但最终无效。一个概念上有吸引力的答案，机械设备的“目的地疗法”，是严格限制的电源：目前的根本不兼容的人恢复到移动的，完全活跃的生活安全-这些设备的一个明确的目标。反过来，一个概念上有吸引力的答案，这个权力的问题，骨骼肌利用，是严重限制了失败的力传递肌肉假体接口。 我们已经解决了。MyoCouplerTM使用大量极细的聚合物纤维，分散在肌肉的远端，将界面应力从> 10，000 mmHg（传统缝线和夹钳）降低到现有的间质肌压力。 第一阶段证明了可行性;一个独立的小组在不同的动物模型中重现了结果。此外，我们的第二阶段合同研究合作伙伴开发了一种液压传输系统，除了这种失败的接口困境之外，该系统高效，有效和可靠。 具体目标是：1）设计并记录符合监管标准的器械，2）对其进行系统性测试，3）使用经确认的体内模型证明循环能量转移的长期可靠性。结果将使下一个商业化步骤-GLP动物研究。这样，真正独立的机械支持将是现实的。

DESCRIPTION (provided by applicant):Severe Heart failure kills 100,000 Americans yearly. Heart transplants are effective but scarce; medicines are available but - eventually - ineffective. A conceptually attractive answer, mechanical device 'destination therapy', is critically limited by power sources: present ones simply aren't compatible with safety in people restored to mobile, fully active lives - a clear goal of these devices. In turn, a conceptually attractive answer to this power problem, skeletal muscle harnessing, is critically limited by failure of force- transferring muscle-to-prosthesis interfaces. We've solved this. The MyoCouplerTM uses a myriad of extremely fine polymer fibers, dispersed very distally in the muscle, reducing interface stress from > 10,000 mmHg (conventional sutures and clamps) to the existing interstitial muscle pressure. Phase I proved feasibility; an independent group reproduced results in a different animal model. Further, our Phase II contracting research partner developed a hydraulic transfer system that is - except for this failing-interface dilemma - efficient, effective, and reliable. Specific aims are: 1) designing and documenting a device complying with regulatory standards, 2) systematically testing it, and 3) demonstrating long-term reliability of cyclic energy transfer using a validated in vivo model. Results will enable the next commercialization step - a GLP animal study. Truly self-contained mechanical support will then be realistic.