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

DESCRIPTION (provided by applicant): 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 two key components. First, an innovative low-cost terminal device will be developed by combining two 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 two 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. 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.