Hybrid Electrical-Mechanical Pump for Vacuum Suspension of Prosthetic Sockets

假体插座通过各种悬挂技术固定在残肢上，包括 机械(皮带、销锁衬垫)和吸气(密封套、单向阀、真空泵)系统。 有力的证据表明，真空辅助悬架(VAS)比其他悬架更有优势 技术，包括：减少影响眼窝适合性的残存肢体体积波动，改善步态 对称性，减少残肢与窝之间的相对运动，促进残肢愈合 创伤，以及应用于残肢较短的假肢使用者。商用泵的设计可以是 机械的或电气的，各有其独特的优缺点。混合式集成泵 项目倡议(HIPI)开始于2010年，是国防部资助的一个项目的一部分，并导致 泵技术的设计结合了电气和机械系统，以实现VAS，而不受 用户状态，同时最大限度地延长电池寿命和最大限度减少噪音。河马技术经历了 初步评价证明了可行性，但强调了进一步改进的必要性。这个 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，以 吸引行业合作伙伴，通过未来的协作努力，与他们合作开发面向市场的设备。这 该设备将对退伍军人健康管理局具有相当大的价值，因为它提供的技术将 适用于希望通过最少的电池充电快速生成VAS的活动患者和老年患者 他们依赖持续的VAS，而不需要不断地加载他们的假体。 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 旨在提高商业可行性并确保截肢者使用的有效性。这些需求将 通过这项工作的开发活动来解决，包括阶段门设计流程、工作台 和人体试验，以及利益相关者的意见。我们计划改进机电混合动力 真空泵的设计通过：1)优化机械泵系统，确保产生最大液位 与现有真空泵相当的真空度；2)无缝集成微处理器控制的 电动泵系统，用于监控真空水平，并在压力降至设定值以下时重新接合系统 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以及与工业设计师和我们的行业合作伙伴的咨询， 增强商业生存能力。HIPPI系统的每个迭代原型都将经历BASE和人类 受试者测试。电气系统将进行台式测试，以量化系统运行的时间和速度 在密封的体积中达到最低要求的真空度，并验证微处理器 识别标高何时低于预定义的值，并激活以重新建立该标高。这个 机械系统将进行台架测试，以量化循环次数，以达到足够的真空度和 验证设备是否满足结构ISO 10328标准(静态强度和耐久性)。原型将会 也在实验室对膝下和膝上肢体丧失的个人进行评估，以验证 在行走过程中，泵能在假体衬套和承窝之间达到并维持足够的真空水平。 但不会显著改变插座反应时刻。该项目的可交付成果将是一个精炼和 适用于VAS资深用户的工作HIPPI原型，无论其年龄、性别或 活动级别。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，以继续商业化努力并评估 在大规模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.