Hybrid Electrical-Mechanical Pump for Vacuum Suspension of Prosthetic Sockets

假肢接受腔通过各种悬吊技术固定在残肢上，包括 机械（皮带，销锁定衬垫）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吊（VAS）优于其他悬吊 技术，包括：减少残肢体积波动，损害插座适合，改善步态 对称，减少残肢与接受腔的相对运动，促进残肢愈合 创伤和应用于具有短残肢的假肢使用者。商业泵设计是 机械的或电气的，每种都具有独特的优点和缺点。混合集成泵 项目倡议（HIPPI）始于2010年，是国防部资助项目的一部分， 泵技术的设计，包括电气和机械系统，以实现VAS，而不考虑 用户的状态，同时最大化电池寿命和最小化噪声。HIPPI技术经历了 初步评估表明可行性，但强调需要进一步加强。的 该项目的目的是进一步设计和评估HIPPI系统，并提高商业可行性， 吸引行业合作伙伴，通过未来的合作努力，与他们一起开发市场就绪的设备。这 该设备将通过提供技术， 适用于需要快速生成VAS且电池充电最少的活动患者和老年患者 依靠持续VAS而不需要持续加载假体的患者。 虽然我们的设计吸引了多家假肢制造商的兴趣，但设计改进必须 以提高商业可行性并确保截肢者的使用效果。这些需要将 通过这项工作的开发活动来解决，包括阶段-闸门设计过程、工作台 和人类受试者测试，以及利益相关者的投入。我们计划改进混合电力机械 真空泵的设计通过：1）优化机械泵系统，保证产生最大的水平 真空度可与现有真空泵相媲美，2）无缝集成微处理器控制的 电动泵系统，用于监控真空度，并在压力福尔斯降至设定值以下时重新启用系统 最小在设计过程中，将进行工业设计和以用户为中心的市场调查 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， 提高商业可行性。HIPPI系统的每个迭代原型都将经过台架和人工测试。 主题测试将对电气系统进行台架测试，以量化系统 在密封体积内达到最低要求的真空水平，并验证微处理器 当液位福尔斯低于预定值时，识别并激活以重新建立该液位。的 将对机械系统进行台架测试，以量化达到足够真空水平的循环次数， 验证器械是否符合结构ISO 10328标准（静态强度和耐久性）。原型将 也可以在实验室中对膝盖以下和膝盖以上肢体缺失的个体进行评估，以验证 在行走过程中，泵可以在假肢内衬和接受腔之间实现并维持足够的真空水平 但不会显著改变承窝反作用力矩。该项目的交付成果将是一个完善的， 工作HIPPI原型，适用于VAS的资深用户，无论其年龄、性别或 活动水平。这项工作的结果将使我们能够很好地将这项技术转让给商业伙伴 并与他们参与竞争性的研究提案，以继续商业化的努力，并评估 大规模VA临床研究中的临床疗效。

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.