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.

项目概述/摘要：与目前进入矫形和假肢（O&P）市场的产品趋势一致，上肢假肢在技术上变得越来越复杂和昂贵。由于各种原因，有一群处境不利的截肢者无法负担这些非凡的新辅助器具，也无法从中受益；随着价格的攀升，越来越多的截肢者受到进一步的创伤，发现自己成为了这个群体的一员。据一些调查人员估计，除了美国，全球上肢截肢者的人数高达2500万人；其中约80%生活在农村地区，以农业和畜牧业为生。在几个发展中国家进行的有限调查表明，人们对辅助器具的需求很大，如果提供辅助器具将大大提高生产力，帮助截肢者获得并享受更高的整体生活质量。第一阶段SBIR项目旨在证明生产一种上肢假肢系统的可行性，该系统可以经济地分发给美国和国外的截肢者，以克服治疗差距，满足这些服务不足的群体的需求。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、家庭和整个社会受益。各种人道主义机构正在积极提供下肢用具；这些团体报告说，由于缺乏负担得起的硬件，他们帮助上肢截肢者的努力受到阻碍；捐赠的二手设备目前正在使用，但不足以满足需要，在某些情况下，这种做法是法律所禁止的。为了满足这一需求，ADA的高素质研究团队将创建一个由两个关键部件组成的假肢系统。首先，一种创新的低成本终端设备将通过结合两种现有的和经过验证的技术来开发：1)功能强大的抓取数字，专门提供多种抓取模式；2)在美国农民和牧场主中非常受欢迎的自动开启驱动机制，该机制已经证明了极高的实用性和可靠性。其次，国际上已经用于下肢关节的廉价支架技术将被应用于上肢。将这两个组件（一个创新的终端装置和插座）集成到一个单一系统中，将构成一个可用的假肢系统，适合大规模制造和分发给处境不利和服务不足的截肢者。正如预期的那样，第二阶段需要进行人体临床试验，以充分验证该系统，并确定文化适应性，以提高实用性和接受度，而第三阶段则针对大规模商业生产。已经确定了分销渠道，并表示一旦ADA的系统可用，他们渴望向客户提供ADA的系统。项目简介：在美国和国外，上肢截肢者需要一种负担得起的电缆操作（传统）辅助器具。这类装置帮助截肢者恢复功能，使他们能够重返有利于自己、家人和国家的生产性职业；随着这些功能的恢复，我们会重新获得自给自足、目标感和新发现的快乐。目前，不断上涨的成本和明显缺乏合适的硬件，导致越来越多的截肢者得不到服务，他们不能公平地从石油和石油部门的技术进步中受益。