A Next-Generation Split Hook Prehensor with Enhanced Grasp Functionality

描述（由申请人提供）：由于某些固有的优点，令人惊讶的是，大量上肢截肢者更喜欢简单的电缆操作的假肢和分裂钩终端设备用于许多活动。对于美国和发展中国家处境不利的截肢者来说，这种系统往往是唯一可行的恢复性选择。ADA技术公司及其截肢者和假肢专家的支持网络认为，帮助这些用户的一种有效方法是创造一种重量轻、坚固耐用、耐腐蚀的新型分离钩，提供两种令人耳目一新的功能改进：1）一种易于调节夹紧力以匹配任务需要并最大限度地减少影响抓握的肌肉能量消耗的方法;以及2）视觉上更吸引人的抓握轮廓，其提供稳定、高质量的抓握而不损坏使用者的物品。ADA的使命是开发创新的新型传统假肢技术，使全球用户受益，与此一致，SBIR计划的主要目标是创建一种多功能的下一代分裂钩终端设备，使美国和国外的上肢截肢者感到高兴，并且可以以低成本制造，以促进全球分销。在第一阶段，通过以前的研究开发的功能抓轮廓相结合的创新捏力调节机制，在视觉上吸引人的设计。与外部制造商的合作确保了这种设计充分利用材料和工艺，以最大限度地降低制造成本。原型设备的现场试验验证了它提供了出色的抓持功能，评估人员热情地赞扬了它的可调节夹持力能力。由于ADA的分裂钩重量轻，平均需要比基准单位少53%的能量来操作，该公司的专家顾问认为，该设备将显着受益于经股动脉和风险截肢者受到累积的创伤损伤和假体使用引起的肌肉病变的困扰。此外，该设备的低制造成本、坚固性和抗电偶腐蚀性使其成为发展中国家弱势截肢者的理想选择，其中超过82%的人靠农业职业生存。第二阶段包括建立生产基础设施，并在代表自给农业和牧场的艰苦条件下验证生产硬件的性能。对经股动脉截肢受试者进行的临床试验将检查该器械对这些用户的潜在受益。该公司还将完成法律要求的任务，将其分裂钩作为商业产品推向全球市场。第三阶段包括制造并向美国和发展中国家的临床医生和人道主义机构提供分裂钩。为了与SBIR计划的精神和意图保持一致，这种方法最大限度地利用了NIH的资金，使那些每天必须科普上肢缺陷的限制和后果的男性和女性直接受益。公共卫生相关性：在美国和发展中国家，非常需要负担得起的上肢假肢组件，因为成本不断上升，技术日益复杂，许多截肢者无法获得大多数现有产品。这里描述的分离钩技术结合了关键的功能创新，同时利用新的材料和制造工艺，使那些喜欢传统假体的截肢者和那些很少或没有其他选择的截肢者受益。该设备旨在取悦用户，通过帮助他们通过重新自给自足，目标感和个人尊严成为或保持社会的生产成员来提高他们的生活质量。

DESCRIPTION (provided by applicant): Owing to certain intrinsic advantages, a surprisingly large number of upper-extremity amputees prefer simple cable operated prostheses and split hook terminal devices for many activities. For disadvantaged amputees in the United States and in developing countries, such systems often present the only viable restorative option. ADA Technologies and its supporting network of amputees and prosthetists believe a powerful way to help these users is to create a lightweight, robust, and corrosion resistant new split hook offering two refreshing functional improvements: 1) a means to readily adjust pinch force to match task need and to minimize the muscular energy expended effecting grasp; and 2) more visually appealing gripping contours that deliver stable, quality grasp without damaging the user's possessions. Consistent with ADA's mission to develop innovative new conventional prosthetic technologies that benefit users worldwide, the Primary Objective of this SBIR program is to create a versatile next-generation split hook terminal device that delights upper-extremity amputees in the United States and abroad and that can be manufactured for low cost to facilitate global distribution. In Phase I, functional grasping contours developed through previous research were combined with an innovative pinch force adjustment mechanism in a visually appealing design. Collaboration with outside fabricators ensured this design fully leverages materials and processes to minimize manufacturing cost. Field trials of the prototype device verify it delivers excellent grasp functionality, and evaluators enthusiastically praised its adjustable pinch force capability. Because ADA's split hook is lightweight and requires on average 53% less energy to operate than benchmark units, the company's expert advisors believe the device will significantly benefit transhumeral and at-risk amputees plagued by cumulative trauma injuries and trapezius muscle pathologies arising from prosthesis usage. Moreover, the device's low manufacturing cost, robustness, and immunity to galvanic corrosion make it ideal for disadvantaged amputees in developing countries, over 82% of whom survive by agrarian occupations. Phase II comprises establishing manufacturing infrastructure and validating the performance of production hardware under strenuous conditions representative of subsistence farming and ranching. Clinical testing with transhumeral amputee subjects will examine potential benefits of the device for these users. The company will also complete tasks required by law to launch its split hook as a commercial product into the worldwide marketplace. Phase III encompasses manufacturing and supplying the split hook to clinicians and humanitarian agencies in the United States and in developing countries. In keeping with the spirit and intent of the SBIR program, this approach maximally leverages NIH funding to directly benefit men and women who must cope daily with the limitations and consequences of upper-limb deficiencies. PUBLIC HEALTH RELEVANCE: In the United States and developing countries, affordable upper-extremity prosthetic components are much needed as escalating costs and increasing technological sophistication have for many amputees placed most existing products out of reach. The split hook technology described here incorporates key functional innovations while leveraging new materials and manufacturing processes to benefit amputees who prefer conventional prostheses and those for whom few or no other options exist. The device is designed to delight users, improving their quality of life by helping them become or remain productive members of society through renewed self-sufficiency, sense of purpose, and personal dignity.