Foot Prosthesis Using Tensegrity Design Principles

采用张拉整体设计原理的足部假肢

• 批准号: 8121171
• 负责人: Jerome Rifkin
• 金额: $ 7.66万
• 依托单位: TENSEGRITY PROSTHETICS, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-03-18 至 2011-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8121171
• 关键词: Achievement; Adult; Americas; Amputation; Amputees; Athletic; Biomechanics; Certification; Comorbidity; Data; Diabetes Mellitus; Disease; Ensure; Epidemic; Exhibits; Eye; Fatigue; Future; Gait; Generations; Goals; Health; Healthcare Industry; Healthcare Systems; Hearing; Heart; Human; Left; Legal patent; Life; Limb structure; Locomotion; Lower Extremity; Maintenance; Marketing; Metabolic; Obesity; Older Population; Oxygen Consumption; Pain management; Patients; Phase; Population; Production; Prosthesis; Quality of Care; Quality of life; Research; Residual state; Running; Sales; Small Business Innovation Research Grant; Staging; Technology; Testing; Time; Trauma; Validation; Vascular Diseases; Visit; Walking; base; commercialization; cost; design; disability; foot; human old age (65+); human subject; improved; innovation; instrument; meetings; news; next generation; novel; prototype; public health relevance; research and development; success

DESCRIPTION (provided by applicant): There are currently between 1.2 and 1.5 million lower-limb amputees in the U.S., and the number of amputations associated with diabetes is expected to triple in the next 15 years. Most amputees are over 65 years old, and this population is not well-served by the "energy-storing" feet that are popular with younger, more-active amputees, because this stiff athletic technology is inherently suited to running and cannot be used by the majority of lower-activity amputees. Currently available "conventional" feet are based on decades-old designs that do not enable amputees to walk normally or efficiently. Tensegrity's innovative, patent-pending foot prosthesis being developed under this multi-phase SBIR project is designed to meet the needs of the majority of amputees who simply want to walk comfortably. Phase I results demonstrated the potential for Tensegrity's novel foot design to result in a competitive commercial prosthetic foot; one that allows for more-efficient and more-effective walking than any prosthesis sold today. Tensegrity's successful 2-year Phase I project leads into a larger Phase II demonstration and validation effort focused on three Aims: 1) complete the design for a commercially ready prosthetic foot, focusing upon durability and the ease of manufacturability to ensure a high-quality product that provides for an efficient stride and a decrease in the applied load on the residual limb; 2) acquire ISO certification for the product; and 3) run a beta test with 50 amputees to verify that the new prosthetic foot will be maintenance-free and durable for at least 6 months after initial fitting. Phase II success will set the stage for Tensegrity's Phase III commercialization effort. This exciting new foot prosthesis will appeal to and will greatly benefit the nearly half-million amputees who have difficulty using current technology. Phase II R&D will involve 1) manufacturing "test feet" from a design proven in Phase I, and 2) completing a variety of bench, fatigue, and human subjects tests on the prosthetic feet. Human testing will include instrumented gait lab testing and metabolic efficiency/oxygen consumption testing. Phase I data indicates that this new foot can be produced at a lower manufacturing cost than current leaf-spring foot designs and will be able to be fitted to patients in 40% less time. This next-generation Tensegrity prosthetic foot design will provide a higher quality of care and quality of life for lower-limb amputees, who will be able to return to activities they once enjoyed because of the greatly improved biomechanics of the foot. We expect that Phase II research results will produce a biomechanically superior, more-comfortable prosthetic foot design ready for commercial production and widespread domestic and worldwide sales. PUBLIC HEALTH RELEVANCE. This SBIR Phase II project is designed to demonstrate that Tensegrity's next-generation prosthetic foot can improve the quality of life and health for a large percentage of current and future amputees who are severely underserved by the prosthetic foot designs available today. Successful prototyping, validation, and commercialization of this new prosthetic foot will benefit 1) lower-limb amputees, who will enjoy a more-normal life with fewer visits to the doctor for pain control because of more comfortable fit and stride; 2) our health care industry's overburdened prosthetists, who will be able to profitably serve more patients in less time; and 3) our nation's financially overburdened health- care system, which will benefit from hundreds of thousands of amputees who are mentally and physically healthier because of this new prosthetic technology

描述（由申请人提供）：目前美国有 1.2 至 150 万下肢截肢者，预计与糖尿病相关的截肢人数在未来 15 年将增加两倍。大多数截肢者年龄都在 65 岁以上，而这一人群并不能很好地适应年轻、活跃的截肢者所流行的“能量储存”脚，因为这种僵硬的运动技术本质上适合跑步，不能被其他人使用。大多数活动量较低的截肢者。目前可用的“传统”脚基于几十年前的设计，无法使截肢者正常或有效地行走。 Tenseggrity 的创新型、正在申请专利的足部假肢是在这个多阶段 SBIR 项目下开发的，旨在满足大多数只想舒适行走的截肢者的需求。第一阶段的结果表明，Tensegrity 新颖的足部设计有潜力产生具有竞争力的商业假足；与当今销售的任何假肢相比，它可以让行走更加高效和有效。 Tensegrity 为期 2 年的第一阶段项目取得成功，进入了更大规模的第二阶段演示和验证工作，重点关注三个目标：1) 完成商业化假脚的设计，重点关注耐用性和易于制造性，以确保高质量的产品提供有效的步幅并减少残肢上施加的负载； 2）产品获得ISO认证； 3) 对 50 名截肢者进行 Beta 测试，以验证新的假足在初次安装后无需维护且耐用至少 6 个月。第二阶段的成功将为 Tenseggrity 第三阶段的商业化工作奠定基础。这种令人兴奋的新型足部假肢将吸引近 50 万难以使用现有技术的截肢者，并将使其受益匪浅。第二阶段的研发将涉及 1) 根据第一阶段验证的设计制造“测试脚”，以及 2) 完成对假脚的各种台架、疲劳和人体测试。人体测试将包括仪器步态实验室测试和代谢效率/耗氧量测试。第一阶段的数据表明，与目前的板簧脚设计相比，这种新脚的生产成本更低，并且安装到患者身上的时间将缩短 40%。这种下一代张拉整体假足设计将为下肢截肢者提供更高质量的护理和生活质量，由于足部生物力学的极大改善，他们将能够恢复他们曾经喜欢的活动。我们预计第二阶段的研究成果将产生生物力学优越、更舒适的假足设计，为商业生产和广泛的国内和全球销售做好准备。公共卫生相关性。 该 SBIR 第二阶段项目旨在证明 Tensegrity 的下一代假足可以改善大部分当前和未来截肢者的生活质量和健康状况，这些截肢者目前的假足设计严重缺乏服务。这种新型假足的成功原型设计、验证和商业化将有利于 1) 下肢截肢者，由于更舒适的贴合和步幅，他们将享受更正常的生活，减少去看医生控制疼痛的次数； 2）我们的医疗保健行业负担过重的假肢师，他们将能够在更短的时间内为更多的患者提供服务并从中获利； 3）我们国家财政负担过重的医疗保健系统将受益于数十万截肢者，他们因这种新的假肢技术而身心更加健康