A Low-Cost Upper-Extremity Prosthesis for Under-Served Populations

为服务不足的人群提供低成本上肢假肢

• 批准号: 7155839
• 负责人: BRADLEY D VEATCH
• 金额: $ 17.79万
• 依托单位: ADA TECHNOLOGIES, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-26 至 2008-03-25
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7155839
• 关键词: amputation; bioengineering /biomedical engineering; biomedical equipment development; cost effectiveness; functional ability; hand; human therapy evaluation; international cooperation; joint prosthesis; medical rehabilitation related tag; medically underserved population; orthopedics; self concept; skeletal prosthesis; vocational rehabilitation

DESCRIPTION (provided by applicant): Project Summary/Abstract: Consistent with the current trend among products reaching the orthotics and prosthetics (O&P) marketplace, upper-extremity prostheses are becoming ever-more technologically sophisticated and expensive. There exists a population of disadvantaged amputees who, for diverse reasons, are unable to afford or benefit from these remarkable new assistive appliances; as prices climb, more amputees are further traumatized to find themselves in this group. Beyond just the United States, the global population of upper-extremity amputees has been estimated by some investigators to be as high as 25,000,000 persons; approximately 80% of these live in rural areas and survive through agriculture and animal husbandry. Limited surveys in several developing nations indicate that assistive appliances are much desired and if made available would substantially boost productivity, helping amputees attain and enjoy an overall higher quality of life. This Phase I SBIR project specifically aims to demonstrate the feasibility of producing an upper-extremity prosthetic system that can be economically distributed to amputees both in the United States and abroad to overcome treatment disparities and meet the needs of these under-served segments. Experience shows that as functionality is restored, amputees regain self-sufficiency and independence; many are able to resume productive occupations, benefiting themselves, their families, and society at large. Various humanitarian agencies are now actively providing lower-extremity appliances; these groups report they are hampered in their efforts to assist upper-extremity amputees by a lack of affordable hardware; donations of used equipment are currently used but are inadequate to address the need, and in some cases this approach is prohibited by law. To meet this need, ADA's well-qualified research team will create a prosthetic system comprising 2 key components. First, an innovative low-cost terminal device will be developed by combining 2 existing and proven technologies: 1) highly functional grasping digits that specifically supply multiple prehension patterns, and 2) a self-energizing voluntary opening drive mechanism, tremendously popular among American farmers and ranchers, that has demonstrated extreme utility and reliability. Second, an inexpensive socket technology that is already used internationally for lower-limb sockets will be adapted for the upper-limbs. Integrated into a single system, these 2 components, an innovative terminal device and socket, will comprise a usable prosthetic system suitable for large-scale manufacture and distribution to disadvantaged and under-served amputee populations. As envisioned, Phase II entails human subject clinical trials to fully validate the system and to identify cultural adaptations that will enhance utility and acceptance, while Phase III is directed to large-volume commercial manufacture. Distribution channels have already been identified and have expressed their eagerness to supply ADA's system to their clients once it is made available. Project Narrative: In the United States and abroad, there is a need among disadvantaged upper-extremity amputees for an affordable cable-operated (conventional) assistive appliance. Such devices help amputees by restoring functionality, enabling them to return to productive occupations that benefit themselves, their families, and their countries; along with this restored functionality comes renewed self-sufficiency, a sense of purpose, and newfound joy. At present, escalating costs and a pronounced lack of suitable hardware have resulted in a growing yet underserved population of amputees who are not equitably benefiting from technological advancements in the O&P sector.

描述（由申请人提供）：项目摘要/摘要：与目前的趋势一致，产品达到矫形和假肢（O&P）市场，上肢假肢正变得越来越技术复杂和昂贵。有一部分处境不利的被截肢者，由于各种原因，无法负担或受益于这些引人注目的新辅助器具;随着价格攀升，更多的被截肢者受到进一步的创伤，发现自己属于这一群体。除了美国之外，一些调查人员估计全球上肢截肢者人数高达25，000，000人;其中约80%生活在农村地区，通过农业和畜牧业生存。在几个发展中国家进行的有限调查表明，人们非常需要辅助器具，如果能够提供，将大大提高生产力，帮助截肢者获得和享受更高的生活质量。第一阶段SBIR项目的具体目标是证明生产上肢假肢系统的可行性，该系统可以经济地分配给美国和国外的截肢者，以克服治疗差异，满足这些服务不足的人群的需求。经验表明，随着功能的恢复，截肢者重新获得自给自足和独立;许多人能够恢复生产性职业，使自己、家人和整个社会受益。各人道主义机构目前正在积极提供下肢器具;这些团体报告说，由于缺乏负担得起的硬件，它们协助上肢截肢者的努力受到阻碍;目前使用捐赠的旧设备，但不足以满足需要，在某些情况下，这种做法是法律禁止的。为了满足这一需求，ADA的高素质研究团队将创建一个由2个关键组件组成的假肢系统。首先，将通过结合两种现有的和经过验证的技术来开发一种创新的低成本终端设备：1）高功能的抓握手指，专门提供多种抓握模式，以及2）自激励的自愿开放驱动机制，在美国农民和牧场主中非常受欢迎，已经证明了极端的实用性和可靠性。第二，国际上已经用于下肢接受腔的一种廉价接受腔技术将适用于上肢。这两个组件（创新的终端设备和承窝）集成到一个系统中，将构成一个可用的假肢系统，适用于大规模制造和分发给处境不利和服务不足的截肢者群体。按照设想，第二阶段需要进行人类受试者临床试验，以充分验证该系统，并确定将提高实用性和接受度的文化适应性，而第三阶段则针对大批量商业生产。分销渠道已经确定，并表示他们渴望提供ADA的系统，一旦它提供给他们的客户。项目叙述：在美国和国外，处于不利地位的上肢截肢者需要一种负担得起的电缆操作（传统）辅助器具。这些设备通过恢复功能来帮助截肢者，使他们能够重新从事有利于自己、家人和国家的生产性职业;沿着这种功能恢复的是重新的自给自足、目标感和新的快乐。目前，不断上升的成本和明显缺乏合适的硬件导致截肢者人数不断增加，但服务不足，他们无法公平地从O&P部门的技术进步中受益。