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）：目前在美国有1.20万至150万个下limb截肢者，与糖尿病相关的截肢数量预计将在未来15年内三倍。大多数截肢者已有65年的历史了，这种人口不受年轻，更活跃的截肢者流行的“能量存储”脚的良好服务，因为这种僵硬的运动技术本质上适合跑步，并且大多数下部运动型amputees无法使用。目前可用的“常规”脚是基于数十年来的设计，这些设计无法使截肢者正常或有效地行走。在这个多相SBIR项目下开发了张力的创新，正在申请专利的脚步假体，旨在满足大多数截肢者的需求，他们只是想舒适地走路。第一阶段的结果证明了张力的新型脚部设计可能导致竞争性的商业假体脚。比今天出售的任何假体可以进行更高效，更有效的步行。张力的成功的2年阶段项目成功地介绍了II期较大的演示和验证工作，重点是三个目标：1）完成商业上准备好的假肢脚的设计，专注于耐用性和易于制造性，以确保提供高质量的产品，以提供有效的稳定性，并在剩余limb上施加较低的载荷； 2）获得该产品的ISO认证； 3）运行具有50个截然序列的Beta测试，以验证新的假肢将在初次安装后至少6个月内无维护且耐用。第二阶段的成功将为张力III期商业化工作奠定基础。这种令人兴奋的新脚假体将吸引并将极大地使使用当前技术困难的近50万截肢者受益。 II期研发将涉及1）从I期经过验证的设计中制造“测试脚”，以及2）在假肢上完成各种长凳，疲劳和人类受试者测试。人类测试将包括仪器步态实验室测试和代谢效率/氧气消耗测试。第一阶段的数据表明，与当前的叶子脚部设计相比，可以以低制造成本生产新脚，并且能够在40％的时间内适合患者。这种下一代的张力假肢设计将为下limb amputees提供更高的护理和生活质量，因为脚的生物力学大大改善了，他们将能够重返他们曾经享受的活动。我们预计，第二阶段的研究结果将产生一种在生物力学上更高，更舒适的假肢设计，准备用于商业生产，并广泛使用国内和全球销售。公共卫生相关性。 这个SBIR II期项目旨在证明，紧张的下一代假肢可以改善当前和未来的截肢者的大部分截肢者的生活质量和健康，这些脚the脚受到当今可用的假肢脚部设计的严重服务。成功的原型制作，验证和商业化这种新的假肢将受益1）下limb amuputees，由于更舒适的合身和步伐，他们将享受更正常的生活，以减少对医生进行疼痛控制； 2）我们的医疗保健行业负担重大的假肢，他们将能够在更少的时间内为更多的患者提供盈利； 3）我们国家的财务负担负担重大 - 将受益于成千上万的截肢者，因为这种新的假肢技术在精神和身体上都更健康