Hybrid Electrical-Mechanical Pump for Vacuum Suspension of Prosthetic Sockets

用于假肢接受腔真空悬挂的混合机电泵

• 批准号: 10088337
• 负责人: Matthew J. Major
• 金额: --
• 依托单位: JESSE BROWN VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10088337
• 关键词: Address; Age; Amputation; Area; Charge; Clinical Research; Computers; Consultations; Department of Defense; Development; Devices; Disadvantaged; Ensure; Esthetics; Evaluation; Feedback; Focus Groups; Funding; Future; Gender; Generations; Health; Housing; Hybrids; Individual; Industrialization; Knee; Laboratories; Leg; Legal patent; Life; Limb Prosthesis; Limb structure; Manufacturer Name; Market Research; Mechanics; Methodology; Microprocessor; Monitor; Motion; Noise; Patients; Performance; Periodicity; Persons; Positioning Attribute; Process; Prosthesis; Pump; Reaction; Research Proposals; Respiratory Diaphragm; Secure; Structure; Suction; Suspensions; System; Techniques; Technology; Technology Transfer; Testing; Time; Universities; Vacuum; Vacuum Pumps; Veterans; Veterans Health Administration; Walking; Work; base; clinical efficacy; commercialization; design; falls; gait symmetry; healing; human subject; improved; in vivo; industry partner; insight; interest; limb amputation; limb loss; older patient; pressure; prosthesis wearer; prosthetic socket; prototype; residual limb; seal; success; wound

Prosthetic sockets are secured to the residual limb by a variety of suspension techniques, including mechanical (straps, pin locking liners) and suction (sealing sleeves, one-way valves, vacuum pumps) systems. Evidence strongly suggests the benefit of vacuum-assisted suspension (VAS) over other suspension techniques, including: reducing residual limb volume fluctuations that compromise socket fit, improving gait symmetry, reducing relative motion between the residual limb and socket, facilitating healing of residual limb wounds, and application to prosthesis users with short residual limbs. Commercial pump designs are either mechanical or electrical, each having unique advantages and disadvantages. The Hybrid Integrated Pump Project Initiative (HIPPI) began in 2010 as part of a Department of Defense funded project and resulted in the design of pump technology that incorporates electrical and mechanical systems to achieve VAS irrespective of the state of the user while maximizing battery life and minimizing noise. The HIPPI technology underwent preliminary evaluation demonstrating feasibility but highlighting the need for additional enhancements. The purpose of this project is to further design and evaluate the HIPPI system and enhance commercial-viability to attract industry partners with whom to generate a market-ready device through future collaborative efforts. This device would have considerable value for the Veterans Health Administration by offering technology that would apply to active patients who desire rapid generation of VAS with minimal battery recharging, and older patients who rely on sustained VAS without the need to continuously load their prosthesis. While our design has attracted interest from multiple prosthetics manufacturers, design improvements must be made to enhance commercial-viability and ensure efficacy of use in persons with amputation. These needs will be addressed through the development activities of this work including stage-gate design processes, bench and human subject testing, and input from stakeholders. We plan to refine the hybrid electrical-mechanical vacuum pump design by: 1) optimizing the mechanical pump system to ensure generation of a maximum level of vacuum comparable to existing vacuum pumps, and 2) seamlessly integrating a microprocessor-controlled electrical pump system to monitor vacuum level and reengage the system when pressure falls below a set minimum. During the design process, industrial design and user-centered market research will be conducted through stakeholder focus groups and consultation with an industrial designer and our industry partner to enhance commercial viability. Each iterative prototype of the HIPPI system will undergo bench and human subject testing. The electrical system will be bench tested to quantify the time and rate by which the system achieves the minimum-required vacuum level in a sealed volume, and verify that the microprocessor recognizes when the level falls below a predefined value and activates to reestablish that level. The mechanical system will be bench tested to quantify the number of cycles to achieve sufficient vacuum level and verify that the device satisfies structural ISO 10328 standards (static strength and durability). A prototype will also be assessed on individuals with below-knee and above-knee limb loss in the laboratory to verify that the pump can achieve and sustain sufficient vacuum level between the prosthetic liner and socket during walking but does not considerably alter socket reaction moments. The deliverable from this project will be a refined and working HIPPI prototype that will be applicable to Veteran users of VAS irrespective of their age, gender, or activity level. The results of this work will position us well to transfer this technology to a commercial partner and engage with them in competitive research proposals to continue commercialization efforts and evaluate clinical efficacy in large-scale VA clinical studies.

假肢插座可以通过多种悬架技术固定在残留的肢体上 机械（皮带，销锁定衬里）和吸力（密封套，单向阀，真空泵）系统。 证据强烈表明真空辅助悬架（VA）比其他悬架的好处 技术，包括：减少损害插座的残留肢体体积波动，改善步态 对称性，减少残留肢体和插座之间的相对运动，促进残留肢体的愈合 伤口，并适用于肢体短的假体使用者。商业泵设计要么 机械或电气，每种都有独特的优势和缺点。混合集成泵 项目倡议（HIPPI）始于2010年，作为国防部资助项目的一部分，并导致了 泵技术的设计，该技术结合了电气和机械系统，以实现VAS 用户的状态同时使电池寿命最大化并最大程度地减少噪音。河比技术接受了 初步评估表明可行性，但突出了需要进行其他增强功能的必要性。这 该项目的目的是进一步设计和评估HIPPI系统并增强商业可行性 吸引与之通过未来的合作努力来生成市场就绪设备的行业合作伙伴。这 通过提供技术，设备将对退伍军人卫生管理具有相当大的价值 适用于希望快速生成VA的活跃患者，并以最小的电池充电和老年患者 依靠持续的VA，而无需不断加载假体。 尽管我们的设计吸引了多个假肢制造商的兴趣，但设计的改进必须是 为了提高商业易害性并确保在截肢者中使用的功效。这些需求会 通过这项工作的开发活动来解决，包括舞台设计过程，长凳 和人类受试者测试，以及利益相关者的投入。我们计划完善混合机械机械 真空泵设计作者：1）优化机械泵系统以确保产生最大水平 与现有真空泵相当的真空吸尘器和2）无缝整合微处理器控制的 电动泵系统监视真空水平并在压力下降以下时重新连接系统 最低限度。在设计过程中，将进行工业设计和以用户为中心的市场研究 通过利益相关者焦点小组并与工业设计师和我们的行业合作伙伴进行磋商 增强商业生存能力。 Hippi系统的每个迭代原型都会经过板凳和人类 主题测试。电气系统将进行台式测试，以量化系统的时间和速率 在密封的体积中达到最低含量的真空水平，并验证微处理器是否存在 认识到水平何时低于预定义的值并激活以重新建立该水平。这 机械系统将进行台式测试，以量化以达到足够的真空水平和 验证该设备是否满足结构ISO 10328标准（静态强度和耐用性）。原型会 还可以评估实验室中膝盖低于膝盖和膝盖肢体损失以上的人 泵可以在步行过程中实现并维持假肢和插座之间的足够真空水平 但不会大大改变插座反应力矩。该项目的可交付将是一个精致的， 工作的河比原型将适用于VAS的资深使用者，无论其年龄，性别或 活动水平。这项工作的结果将使我们很好地将这项技术转移给商业合作伙伴 并与他们参与竞争性研究建议，以继续商业化工作并评估 大规模VA临床研究中的临床功效。