A Biomimetic Prehensile Digit for Upper-Limb Amputees

描述(由申请人提供)：假肢通过鼓励平衡的、双手的肢体使用来降低上肢截肢者对侧过度使用综合症的发生率。好处包括减轻疼痛和肌肉萎缩，提高生产力和自力更生，改善自我形象，幸福感和社会接受度增加。身体动力假体因其相对经济实惠、高可靠性和良好的实用性在美国和国外得到了广泛的应用。隐形手企业(IHE)，LLC正在开发一种创新的仿生可抓取数字技术，将把这些好处扩展到两个未得到充分服务的人群：1)手部分截肢者，他们几乎没有能够进行有效抓取的部件；2)世界各地的上肢截肢者，由于社会和文化接受的原因，他们需要类似于解剖手的假肢终端设备，具有良好的美容和逼真的运动。在这项小型企业创新研究(SBIR)计划的第一阶段，IHE展示了其核心数字技术在技术和经济上的可行性。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，从而制造出成本低、重量轻、特别坚固且不需要润滑的设备。作为模块化的构建块， 手指在临床上是灵活的，使修复师能够创造出部分手假体，优化了t功能，与剩余的自然手指相协调。这些数字被整合到一个全手终端设备中，提供了让截肢者，特别是女性在心理上感到满意的美容和动作，并有助于转移人们对肢体缺陷污名根深蒂固的地区的关注，这些地区往往会导致社会排斥。在第二阶段，研究所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发的模块化数字形式。数字还将被整合到以前开发的现有手部结构中，该结构受到截肢者评估者的高度赞扬，但因缺乏缆索操作和逼真的运动而遭到拒绝。这些产品将使用经过验证的和行业批准的评估方案以及扩展的现场性能验证进行临床评估，所有这些都由志愿者受试者执行。将建立制造基础设施和生产流程，以支持第三阶段商业化活动。模块化数字和全手终端设备将通过IHE现有的美国和国际分销商以及人道主义机构作为商业产品推向市场。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质量的生活。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.