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

描述（由申请人提供）：进入矫形器和假肢市场的新上肢辅助器具在技术上越来越复杂和昂贵，这导致越来越多的截肢者由于各种原因无法获得或使用它们，从而无法享受任何好处。目前估计全世界上肢截肢者的人数接近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。帮助这些截肢者是有利的，因为经验表明，随着功能的恢复，恢复了自给自足和独立，大多数安装了功能性假肢的截肢者恢复了生产性职业，使他们自己、他们的家庭和整个社会受益。因此，一些人道主义机构侧重于提供辅助器具，虽然存在下肢假肢备选办法，但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。这三个阶段SBIR计划的基本目标是创建一个完整的上肢假肢，可以大规模生产和销售，使弱势截肢者能够和高兴，他们很少或没有其他可行的康复选择。在该SBIR项目的I期，ADA成功证明了一种新型低成本上肢假体的技术和经济可行性，该假体专门设计用于在美国和国外销售，以克服影响服务不足人群的治疗差异。根据活跃在人道主义救援工作中的专家假肢专家的建议，ADA的假肢系统为截肢者带来了具体的好处：1）它很舒适，恢复了有用的抓握功能; 2）它减轻了截肢造成的情感和心理冲击，并培养了积极的自我形象; 3）它恢复了一个更正常的外观，支持社会接受，特别是在对毁容和残疾有强烈成见的文化中。第二阶段包括两个阶段的现场验证，涉及人类受试者。这些评估将得到IRB的批准，并将使ADA的高素质研究团队能够充分验证系统的性能，截肢者使用它的功能熟练程度，以及它在文化背景下的可接受性。将开发一套包括假体和其他材料的工具包，以促进全球销售，同时帮助截肢者熟练掌握并能够在生活中最大限度地利用这些系统。最后，将建立制造基础设施以满足第三阶段的市场需求;分销渠道已经存在，并已表示渴望开始向其客户提供ADA的系统。

DESCRIPTION (provided by applicant): New upper-extremity assistive appliances coming into the orthotics and prosthetics (O&P) market are increasingly technologically sophisticated and expensive, which has given rise to a growing population of amputees who cannot obtain them or make use of them for various reasons and thereby enjoy no benefit. Current estimates put the number of upper-extremity amputees worldwide at nearly 25,000,000 persons, with approximately 80% of these living in rural areas and surviving through agriculture and animal husbandry. It is advantageous to help these amputees because experience has shown that with functional restoration comes renewed self-sufficiency and independence, and a majority of amputees fit with functional prostheses resume productive occupations, benefiting themselves, their families, and society at large. For this reason, some humanitarian agencies focus on providing assistive appliances, and while lower-extremity prosthetic options exist, they have been hampered in their efforts to assist upper-extremity amputees owing to a lack of affordable hardware. The Fundamental Objective of this three-phase SBIR program is to create a complete upper-extremity prosthesis that can be manufactured and distributed on a large scale to enable and delight disadvantaged amputees for whom few or no other viable rehabilitative options exist. In Phase I of this SBIR project, ADA successfully demonstrated the technical and economic feasibility of a new low-cost upper- extremity prosthesis intentionally designed for distribution in the United States and abroad to overcome treatment disparities affecting under-served populations. As recommended by expert prosthetists active in humanitarian relief efforts, ADA's prosthetic system conveys specific benefits to amputees: 1) it is comfortable and restores useful grasping function; 2) it alleviates emotional and psychological shock caused by amputation and fosters a positive self-image; and 3) it restores a more normal appearance that bolsters social acceptance, particularly in cultures having strong stigmas against disfigurement and disability. Phase II incorporates two stages of field validations involving human subjects. These evaluations will be IRB- approved and will enable ADA's well-qualified research team to fully validate the system's performance, amputees' functional proficiency using it, and its acceptability in a cultural context. A kit comprising the prosthesis and additional materials will be developed to facilitate global distribution while helping amputees become proficient and able to use the systems to maximum advantage in their lives. Finally, manufacturing infrastructure will be set up to supply Phase III market demand; distribution channels already exist and have expressed their eagerness to begin supplying ADA's system to their clients.