A Bioactuator-Driven Ankle Dorsiflexor Unit

描述（由申请人提供）：在美国，有相当多的人受到疾病和伤害的影响，这些疾病和伤害会导致脚部下垂。糖尿病、血管异常疾病、周围神经病变和其他疾病使一些人在步态周期中无法有效地抬起脚，使他们容易跌倒或受伤。目前，踝足矫形器（AFOs）通常用于使足部更有利于行走，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种外部佩戴，易于穿戴的系统，可以根据佩戴者的自然步态周期及时恢复协调的动力踝关节背屈。在这三个阶段的研究计划中，ADA将利用先前成功的电活性聚合物致动器研究来开发这种踝关节背屈系统。通过早期由美国国立卫生研究院资助的研究，ADA已经证明了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装置提供动力。这项工作的自然延伸是为了解决足部下降问题，最初是由ADA的支持临床医生网络提出的，并得到了NIH技术审稿人的同意。在第一阶段，ADA将展示使用电活性聚合物致动器来模拟人类脚踝的技术可行性。二期将包括一个完整的功能系统的开发和使用人类志愿者受试者的临床性能验证。商业化将在第三阶段进行，临床医生可以为受足下垂影响的患者开出脚踝背屈肌产品。

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.