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

耐用、承重、肌肉与假肢的连接

• 批准号: 6211159
• 负责人: DAVID B MELVIN
• 金额: $ 9.99万
• 依托单位: CARDIOENERGETICS, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-15 至 2001-03-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6211159
• 关键词: biomaterial compatibility; biomaterial development /preparation; biomaterial interface interaction; circulatory assist; heart prosthesis; laboratory rabbit; medical implant science; muscle strength

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.

尽管目前有各种治疗方法，但每年仍有超过 100,000 名美国人死于心力衰竭。一项有希望的治疗创新建议采用多个骨骼肌，通过液压方式与已经证明有效的机械支撑装置相连。但所需的耐久承重肌肉与假体界面从未成功，可能是因为组织无法承受当必要的力满足可用横截面积时产生的压力（范围高达 40,000 毫米汞柱）。通过将超细聚合物纤维分散在肌肉远端，显着增加力传递表面，可以解决这个困境，特别是如果不间断的退出纤维被整体组织成不可伸展的绳索。这就是 MyoCoupler(TM)。通过现实的摩擦系数和生理组织压力可以获得有效的力传递。在为期 30 天的兔子试验中，简单的拉拔强度是预计需求的九倍。我们将在 20 只兔子的胫骨后肌群的对侧（随机侧分配）植入装置和对照（由支撑缝合线固定的相同绳索），持续 90 天至 16 天，以进行粘合强度测试； 4 界面超微结构。假设MyoCoupler(TM) 与组织完全结合，提供坚固、耐用、承重的肌肉/假肢粘合，足以为循环支持提供动力。预期的结果将有力地支持对人工心脏、辅助装置和心壁致动器的肌肉动力机制的积极追求。拟议的商业应用：肌肉到假肢耦合器可以在无需外部电源的情况下提供循环支持。这将降低大多数因心力衰竭而死亡或致残的人的风险并提高他们的生活质量——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。该设备的复杂程度类似于心脏瓣膜或关节假体，单价为 2,000 美元至 4,000 美元。这每年产生 4 亿至 24 亿美元的国内市场。