A DURABLE, LOAD-BEARING, MUSCLE-TO-PROTHESIS COUPLING

尽管目前有各种治疗方法，每年仍有超过10万美国人死于心力衰竭。一个有希望的治疗创新建议采用多个骨骼肌，液压连接到电力已经证明的机械支持设备。但是，所需的耐用的承重肌肉-假体界面从未成功，可能是因为组织无法承受当必要的力满足可用的横截面积时产生的压力-范围为40，000 mmHg。通过在肌肉远端分散超细聚合物纤维来显著增加力传递表面，可以解决这个难题，特别是如果不间断的退出纤维被整体组织成不可伸展的索。这就是MyoCoupler（TM）。有效的力传递可通过真实的摩擦系数和生理组织压力获得。30天家兔试验中的简单拔出强度是预计需要的9倍。我们将在20只家兔的胫骨后肌群中植入器械和对照品（通过支撑缝线固定的相同绳索）（随机侧分配），持续90天-16天用于粘合强度测试; 4天用于界面超微结构测试。假设MyoCoupler（TM）与组织完全整合，以提供足以为循环支持提供动力的坚固耐用的承重肌肉/假体结合。预期的发现将有力地支持对人工心脏、辅助装置和心脏壁致动器的肌肉动力机制的积极追求。拟议的商业应用：肌肉-假体耦合器可在无外部电源的情况下提供循环支持。这将降低风险并改善大多数现在死于心力衰竭或因心力衰竭而残疾的人的生活质量-仅在美国每年就有50，000至100，000人的潜在市场，每人使用4至6个耦合器。该设备的复杂性类似于心脏瓣膜或关节假体，支持2，000至4，000美元的单价。这产生了每年4亿至24亿美元的国内市场。

Over 100,000 Americans die yearly of heart failure despite all present treatments. One promising suggested treatment innovation employs multiple skeletal muscles, hydraulically linked to power already-proven mechanical support devices. But the required durable load-bearing muscle-to-prosthetic interface has never succeeded, perhaps because tissue cannot tolerate the pressures generated-ranging to 40,000 mmHg-when necessary forces meet available cross-sectional areas. Dramatically increasing the force-transfer surface, by dispersing ultrafine polymer fibers distally in the muscles, may solve the dilemma, particularly if uninterrupted exiting fibers are integrally organized into a non-extensile cord. That is the MyoCoupler(TM). Effective force-transfer is obtainable with realistic friction coefficients and physiologic tissue pressures. Simple pull-out strength in a pilot 30 day rabbit test was nine times projected need. We will implant devices, and controls (identical cords fixed by buttressed sutures) contralaterally (random side assignment), in the posterior tibial muscle groups of 20 rabbits for 90 days-16 for bond-strength testing; 4 for interface ultrastructure. The hypothesis is that the MyoCoupler(TM) integrates thoroughly with tissue to provide a strong, durable, load-bearing muscle/prosthetic bond adequate for powering circulatory support. Expected findings would strongly support aggressive pursuit of muscle- powered mechanisms for artificial hearts, assist devices, and heart wail actuators. PROPOSED COMMERCIAL APPLICATIONS: The Muscle-to prosthesis coupler could provide circulatory support free of external power. This would reduce the risk and improve quality of life for the majority of those now dying with or disabled by heart failure-a potential market of 50,000 to 100,000 people in the USA alone each year, each utilizing 4 to 6 couplers. The complexity of the device is similar to a heart valve or a joint prosthesis, supporting a unit price of $2,000 to $4,000. This yields a domestic market of $400 million to $2.4 billion annually.