A Biomimetic Prehensile Digit for Upper-Limb Prostheses

描述（由申请人提供）：在涉及上肢的截肢类型中，部分手是迄今为止最普遍的，也是假肢专家最难解决的问题之一。这些截肢者的健侧过度依赖导致对侧过度使用综合征（COS）的高患病率，这是一种进行性、疼痛和使人衰弱的疾病。研究表明，假肢通过鼓励更平衡的双手肢体使用来降低COS的发生率。因此，人们对为部分手截肢者开发新的假肢选择有浓厚的兴趣。与此同时，在某些发展中国家，利用强迫截肢来煽动恐怖，加上根深蒂固的文化耻辱，使越来越多的截肢者在国外，他们需要功能和外观更逼真的假肢，以帮助他们重新融入社会和重新获得社会接受。Invisible Hand Enterprises，LLC（IHE）正在开发一种新的关节数字技术，它认为通过创造具有出色美观和抓握功能的经济实惠的部分和全手假肢，有可能帮助满足这两种重叠的需求。在这个三阶段的小企业创新研究（SBIR）计划的第一阶段，IHE将完成其数字技术的开发，并启动与志愿受试者的现场验证测试，以评估商业开发是否合理。IHE的手指系统利用合成纺织纤维的特性和功能特征，复制解剖手指内韧带、肌腱和软骨关节的关键功能，沿着由工程树脂制成的“骨”元件。这种新的弹性手指技术是有目的的强大，重量轻，价格便宜，并实现了出色的自适应把握与惊人的逼真的运动。IHE将与Lake Prosthetics & Research，LLC（LPR）合作，完善其设计并最大限度地提高其临床多功能性，解决经常被忽视的问题，例如连接方式，可调节定位和有效的电缆布线。将制造原型手指，并将其纳入3个部分和3个全手假体中。志愿受试者将佩戴这些假肢，以评估手指在艰苦的现实世界操作条件下的表现。第二阶段包括改进设计以解决第一阶段中确定的问题，扩大测试以包括更苛刻的任务和环境，并建立制造基础设施以支持第三阶段的商业化活动。IHE的存在是为了为世界各地的弱势截肢者创造技术和经济上合适的假肢选择，使他们能够重新获得功能，个人尊严，生活乐趣以及社会，文化和部落的接受。该公司的基本目标是通过提供工具来帮助截肢者享受生活，享受更高的生活质量。IHE声称本文件中描述的工作是重要的和有价值的，并且完全符合美国国立卫生研究院（NIH）SBIR计划的精神和目的。 公共卫生相关性：Invisible Hand Enterprises的创新性新型可伸缩手指技术使用合成纺织纤维来实现坚固、轻便且廉价的模块化手指。专为修复师的现成使用而设计，适用于部分和整个手部假体，提供安全，稳定的抓握和逼真的运动，以实现出色的美观。该技术有目的地满足美国和发展中国家对技术和经济上适当的选择的需求，帮助用户参与并为他们的家庭和社会做出贡献。

DESCRIPTION (provided by applicant): Among amputation types involving the upper limbs, partial hand is the most prevalent by far and among the most challenging for prosthetists to address well. Sound side overreliance for these amputees gives rise to a high prevalence of contralateral overuse syndrome (COS), a progressive, painful, and debilitating condition. Research shows that prostheses reduce the incidence of COS by encouraging more balanced, bimanual limb usage. Consequently, there is strong interest in developing new prosthetic options for partial hand amputees. At the same time, in certain developing countries the use of forced amputations to incite terror combined with deeply entrenched cultural stigmas have produced a growing population of amputees abroad who need functional and more realistic looking hand prostheses to help them reintegrate and regain social acceptance. Invisible Hand Enterprises, LLC (IHE) is developing a new articulated digit technology it believes holds the potential to help satisfy both of these overlapping needs by making possible the creation of affordable partial and whole hand prostheses having excellent cosmesis and grasp functionality. In Phase I of this three-phase Small Business Innovation Research (SBIR) program, IHE will complete the development of its digit technology and initiate field validation testing with volunteer subjects to assess whether commercial development is justified. IHE's digit system exploits properties and functional characteristics of synthetic textile fibers to replicate key functions of ligaments, tendons, and cartilaginous articulations within the anatomical finger, along with "bone" elements fabricated from engineering resin. This new prehensile digit technology is purposefully robust, lightweight, inexpensive, and achieves excellent adaptive grasp with strikingly lifelike movement. IHE will collaborate with Lake Prosthetics & Research, LLC (LPR) to refine its designs and maximize their clinical versatility, addressing frequently overlooked considerations such as means of attachment, adjustable positioning, and efficient cable routing. Prototype digits will be fabricated and incorporated into three (3) partial and three (3) whole hand prostheses. Volunteer subjects will wear these prostheses to assess the digits' performance under strenuous real-world operating conditions. Phase II comprises making design refinements to address issues invariably identified in Phase I, expanding testing to include more demanding tasks and environments, and establishing manufacturing infrastructure to support Phase III commercialization activities. IHE exists to create technologically and economically appropriate prosthetics options for disadvantaged amputees worldwide, enabling them to regain functionality, personal dignity, joy in living, and social, cultural, and tribal acceptance. The company's fundamental objective is to delight amputees by providing tools that help them relish living and enjoy an even higher quality of life. IHE asserts the work described in this submittal is important and worthwhile, and wholly consistent with the spirit and purposes of the National Institute of Health's (NIH) SBIR program. PUBLIC HEALTH RELEVANCE: Invisible Hand Enterprises' innovative new prehensile digit technology uses synthetic textile fibers to realize modular fingers that are robust, lightweight, and inexpensive. Designed for off-the-shelf use by the prosthetist, they are intended for both partial and whole hand prostheses, providing secure, stable grasp and realistic movement for excellent cosmesis. The technology purposefully addresses needs within the United States and in developing countries for technologically and economically appropriate options that help users participate and contribute to their families and society.