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: 10350559
• 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 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10350559
• 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; 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.

假肢接受腔通过各种悬挂技术固定到残肢上，包括 机械（带、销锁衬套）和抽吸（密封套、单向阀、真空泵）系统。 有证据强烈表明真空辅助悬架 (VAS) 相对于其他悬架的优势 技术，包括：减少影响接受腔贴合的残肢体积波动，改善步态 对称性，减少残肢与接受腔的相对运动，有利于残肢愈合 伤口，以及应用于残肢较短的假肢使用者。商业泵设计是 机械或电气，各自具有独特的优点和缺点。混合集成泵 项目倡议 (HIPPI) 于 2010 年启动，作为国防部资助项目的一部分，并导致 泵技术的设计结合了电气和机械系统以实现 VAS，无论 用户的状态，同时最大限度地延长电池寿命并最大限度地减少噪音。 HIPPI技术经历了 初步评估证明了可行性，但强调需要进一步改进。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 吸引行业合作伙伴，通过未来的合作开发出一款可上市的设备。这 该设备将为退伍军人健康管理局提供可观的价值，因为它提供的技术可以 适用于希望以最少的电池充电速度快速生成 VAS 的活跃患者以及老年患者 他们依赖持续的 VAS，而不需要持续加载假肢。 虽然我们的设计引起了多家假肢制造商的兴趣，但设计改进必须 旨在增强商业可行性并确保截肢患者的使用效果。这些需求将 通过这项工作的开发活动来解决，包括阶段设计流程、工作台 和人体测试，以及利益相关者的意见。我们计划完善混合机电 真空泵的设计通过：1）优化机械泵系统以确保产生最大水平 真空度与现有真空泵相当，2) 无缝集成微处理器控制的 电动泵系统用于监控真空度并在压力低于设定值时重新启动系统 最低限度。设计过程中会进行工业设计和以用户为中心的市场调研 通过利益相关者焦点小组以及与工业设计师和我们的行业合作伙伴的协商 增强商业活力。 HIPPI 系统的每个迭代原型都将经过台架和人工测试 科目测试。电气系统将进行台架测试，以量化系统运行的时间和速率 达到密封空间中所需的最低真空度，并验证微处理器 当液位低于预定义值时进行识别并激活以重新建立该液位。这 机械系统将进行台架测试，以量化达到足够真空水平的循环次数，以及 验证设备是否满足结构 ISO 10328 标准（静态强度和耐用性）。原型将 还可以在实验室对膝盖以下和膝盖以上肢体丧失的个体进行评估，以验证 泵可以在行走过程中在假肢衬垫和接受腔之间实现并维持足够的真空水平 但不会显着改变插座反应力矩。该项目的交付成果将是一个完善且 工作 HIPPI 原型将适用于 VAS 的退伍军人用户，无论其年龄、性别或 活动水平。这项工作的成果将使我们能够很好地将这项技术转让给商业合作伙伴 并与他们一起参与竞争性研究提案，以继续商业化工作并评估 大规模 VA 临床研究中的临床疗效。