A Biomimetic Prehensile Digit for Upper-Limb Amputees

描述（由申请人提供）：假体通过促进双手平衡使用肢体，降低上肢截肢者对侧过度使用综合征的发生率。好处包括减少疼痛和肌肉萎缩，提高生产力和自力更生，改善自我形象，幸福感，增加社会接受度。身体动力假体由于其相对可负担性、高可靠性和优异的实用性而在美国（US）和国外被广泛使用。Invisible Hand Enterprises（IHE），LLC正在开发一种创新的仿生数字技术，将这些好处扩展到两个服务不足的人群：1）部分手截肢者，对于他们来说，很少存在能够有效抓握的部件，和2）上-由于社会和文化原因，世界各地的截肢者需要类似于解剖手的假肢终端设备，验收在小企业创新研究（SBIR）计划的第一阶段，IHE展示了其核心数字技术的技术和经济可行性。聚合物树脂和高性能纺织长丝复制了解剖手指的关键结构和功能，从而使设备成本低，重量轻，非常坚固，并且不需要润滑。作为模块化构建块， 手指在临床上是灵活的，使假肢专家能够创造出与剩余的自然手指协调一致的部分手假肢。这些手指被整合到一个全手终端设备中，可以为截肢者（尤其是女性）带来心理上的满足感和运动，并有助于转移人们对肢体缺陷的偏见根深蒂固的地区的注意力，这些地区往往会导致社会排斥。在第二阶段，IHE将进行必要的设计改进，并将其核心技术转化为适合商业分销的模块化数字形式。手指也将被整合到现有的手部结构中，这是以前开发的，受到截肢者评估人员的高度赞扬，但因缺乏电缆操作和现实运动而被拒绝。这些产品将使用经确认和行业批准的评估方案沿着以及扩展的现场性能确认进行临床评价，所有这些均由志愿受试者进行。将建立生产基础设施和生产工艺，以支持第三阶段商业化活动。模块化数字和整个手持终端设备将作为商业产品推向市场，使用IHE现有的美国和国际分销商，沿着与人道主义机构。IHE的使命是通过提供负担得起的新选择来取悦美国和国外的截肢者，帮助他们享受生活并享受更高的生活质量。这项工作是重要的和有价值的，完全符合国家卫生研究所SBIR计划的精神和目的。

DESCRIPTION (provided by applicant): Prostheses reduce the incidence of contralateral overuse syndrome in upper-limb amputees by encouraging balanced, bimanual limb usage. Benefits include reduced pain and muscular atrophy, increased productivity and self-reliance, improved self-image, a sense of well being, and increased social acceptance. Body- powered prostheses are used extensively in the United States (US) and abroad owing to their relative affordability, high reliability, and excellent utility. Invisible Hand Enterprises (IHE), LLC is developing an innovative biomimetic prehensile digit technology that will extend these benefits to two underserved populations: 1) partial-hand amputees, for whom very few components exist that enable useful grasp, and 2) upper-limb amputees worldwide who need prosthetic terminal devices resembling the anatomical hand with excellent cosmesis and realistic movement for reasons pertaining to social and cultural acceptance. In Phase I of this Small Business Innovation Research (SBIR) program, IHE demonstrated technological and economical viability of its core digit technology. Polymer resins and high-performance textile filaments replicate key structures and functions of the anatomical finger, resulting in devices that are low-cost, lightweight, exceptionally robust, and that require no lubrication. As modular building-blocks, the digits are clinically flexible, enabling prosthetists to create partial-hand prostheses optimized t function in concert with remaining natural digits. Incorporated into a whole-hand terminal device, the digits deliver cosmesis and movements that are psychologically satisfying to amputees, particularly females, and that help deflect attention in regions where stigmas against limb deficiencies are deeply entrenched and often lead to social rejection. In Phase II, IHE will make necessary design refinements and translate its core technology into a modular digit form suitable for commercial distribution. Digits will also be integrated into an existing hand structur, developed previously, that was highly praised by amputee evaluators but rejected for its lack of cable-operation and realistic movement. These products will be clinically evaluated using validated and industry-approved assessment protocols along with extended field performance validations, all performed by volunteer subjects. Manufacturing infrastructure and production processes will be established to support Phase III commercialization activities. Both modular digits and whole hand terminal devices will be brought to market as commercial products using IHE's existing US and international distributors, along with humanitarian agencies. IHE's mission is to delight amputees in the US and abroad by providing affordable new options that help them relish living and enjoy an even higher quality of life. This work is important and worthwhile, and wholly consistent with the spirit and purposes of the National Institute of Health's SBIR program.