A Bioactuator-Driven Ankle Dorsiflexor Unit

描述（由申请人提供）：在美国，有相当数量的人受到疾病和伤害的影响，这些疾病和伤害会引起一种称为足下垂的麻烦状况。糖尿病、血管障碍性疾病、周围神经病变和其他病症使得一些个体在其步态周期期间不能有效地抬起他们的脚，使他们容易跌倒或受伤。目前，踝足矫形器（AFO）通常用于使足部更有利于截肢，功能性电刺激技术也在尝试中取得了一些成功。然而，对于某些人来说，这些方法并不适合或涉及不可接受的医疗风险。一个有吸引力的解决方案是一个外部佩戴，容易穿上系统，恢复协调的动力踝关节背屈与穿着者的自然步态周期的时间。在这三个阶段的研究计划中，ADA将利用以前成功的研究与电活性聚合物致动器开发这样一个踝关节背屈系统。通过NIH资助的早期研究，ADA已经证明其模块化生物致动器技术-有效的假肢肌肉-可以为全尺寸的人类上肢假肢提供动力。这项工作的自然延伸，以解决足下垂的问题，最初建议由ADA的网络支持临床医生与美国国立卫生研究院的技术审查员的一致意见。在第一阶段，ADA将证明使用电活性聚合物致动器来背屈模拟人类脚踝的技术可行性。第二阶段将包括使用人类志愿者受试者开发完整的功能系统和临床性能验证。商业化将在第三阶段进行，随着脚踝背屈肌产品的发布，临床医生可以为受足下垂影响的患者开处方。

DESCRIPTION (provided by applicant): A significant number of individuals in the U.S. are affected by diseases and injuries that give rise to a troublesome condition called foot drop. Diabetes mellitus, dysvascular diseases, peripheral neuropathies, and other conditions render some individuals unable to lift their foot effectively during their gait cycle, leaving them susceptible to falling or injury. Currently, ankle-foot orthoses (AFOs) are commonly used to orient the foot more favorably for ambulation, and functional electrical stimulation techniques are also being tried with some success. For some individuals, however, these approaches are not suitable or involve unacceptable medical risks. An attractive solution is an externally worn, easily donned system that restores coordinated powered ankle dorsiflexion in time with the wearer's natural gait cycle. In this three phase research program, ADA will leverage previous successful research with electroactive polymer actuators to develop such an ankle dorsiflexion system. Through earlier research funded by the NIH, ADA has demonstrated that its modular bioactuator technology-effectively prosthetic muscles-can power full-scale human upper-limb prosthetic appliances. The natural extension of this work to address the problem of foot drop was originally suggested by ADA'S network of supporting clinicians with the concurrence of the NIH's technical reviewers. In Phase I, ADA will demonstrate the technical feasibility of using electroactive polymer actuators to dorsiflex a simulated human ankle. Phase II will encompass the development of a complete functional system and clinical performance validations using human volunteer subjects. Commercialization will follow in Phase III, with the release of an ankle dorsiflexor product clinicians can prescribe for patients affected by foot drop.