Development and clinical assessment of a robust, 3D printed titanium, myoelectric powered prosthetic digit system

强大的 3D 打印钛肌电假肢数字系统的开发和临床评估

• 批准号: 10259073
• 负责人: Rahul Reddy Kaliki
• 金额: $ 102.42万
• 依托单位: POINT DESIGNS, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10259073
• 关键词: 3D Print; Address; Amputation; Amputees; Anatomy; Bilateral; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical assessments; Computer software; Development; Devices; Digit structure; Electrodes; Electromagnetics; Electromyography; Electronics; Employment; Engineering; Ensure; Environment; Failure; Fingers; Focus Groups; Foundations; Future; Goals; Hand; Home; Home environment; Individual; Industry; Instruction; Joints; Laboratories; Light; Lithium; Measurement; Measures; Mechanics; Medical; Medical Device; Metacarpophalangeal joint structure; Methods; Motor; Myoelectric prosthesis; Outcome Measure; Output; Participant; Patients; Performance; Persons; Phase; Polymers; Preparation; Production; Prosthesis; Quality of life; Rotation; Safety; Small Business Innovation Research Grant; Software Design; Solid; Speed; System; Testing; Time; Titanium; United States; Upper Extremity; Validation; Water; Woman; Work; actigraphy; advanced system; base; design; empowerment; experience; flexibility; functional outcomes; graphical user interface; improved; limb loss; men; miniaturize; myoelectric control; patient population; powered prosthesis; primary outcome; professional atmosphere; prosthetic hand; prototype; psychologic; recruit; standard of care; verification and validation

ABSTRACT Approximately 600,000 people live with partial hand amputations in the United States, with an estimated 14,500 new cases occurring each year. Despite the advances in miniaturized electronics and motors, there has been very little advancement in mechatronic prosthetic digits for this underserved patient population. In fact, to date, there is only one myoelectric prosthetic option for patients with partial hand loss in the US. This option is fragile, often limited to light-duty tasks, and is too large to use on most partial hand loss cases. Considering this, it is no surprise that less than half of the individuals with partial hand absence are able to return to their previous employment, and those who do must often make considerable changes to their work-related tasks. Thus, there is a substantial need to deliver a robust, low-profile myoelectric prosthetic digit system. To address this need, we have formed a collaborative development team that has successfully launched six devices, which have been fit on over 3,300 patients with upper limb loss and has significant regulatory experience, having received two 510(k) approvals and five CE marks for upper limb prosthetic devices. With this background, through this Fast-Track SBIR application, our collaborative team will develop and launch the Point Powered system: an advanced mechatronic prosthesis system for individuals with partial hand loss which includes 1) robust Point Powered digits; 2) low profile EMG electrodes; 3) a multi-input controller; 4) an iPad-based user interface and 5) a flexible battery-based power system. The Point Powered system will 1) have industry leading strength and speed, 2) offer anatomical rotation and flexion around the patient’s metacarpophalangeal (MCP) joint, 3) have three anatomically accurate joints and sizes small enough to accommodate over 90% of men and women, and 4) be compatible with future sophisticated control strategies. In Phase I, we will perform three main tasks: 1) complete working prototypes of the electromechanical Point Powered digit, controller, electrodes, and user interface 2) perform iterative testing with a focus group of 5 patients and prosthetists and verify component-level functionality and 3) complete internal verification on the Point Powered system. Successful completion of these tasks will gate the progress of the project to Phase II. In Phase II, the Point Powered system will be evaluated in two aims. In the first aim, we will complete third-party verification to ensure compliance with medical device standards and we will perform clinical validations in preparation for our long-term clinical study. Once the verification and validation steps are complete, a clinical trial will be conducted to evaluate the system in 10 participants with partial hand loss against their standard-of- care treatment. At the conclusion of these studies, we will have established safety and efficacy of the devices and will submit a 510(k) application for premarket clearance. It is our long-term goal that the Point Powered system will achieve a high degree of clinical impact through empowerment of partial hand amputees.

抽象的 在美国，大约有 600,000 人患有部分手部截肢，其中估计有 14,500 人 每年都会出现新病例。尽管微型电子和电机取得了进步，但 对于这一服务不足的患者群体来说，机电假肢方面的进展甚微。事实上，迄今为止， 在美国，对于部分失手的患者来说，只有一种肌电假肢可供选择。这个选项很脆弱， 通常仅限于轻型任务，并且太大而无法在大多数部分失手的情况下使用。考虑到这一点，不 令人惊讶的是，只有不到一半的手部部分缺失的人能够恢复到以前的状态 就业，而那些就业的人通常必须对其与工作相关的任务做出相当大的改变。 因此，迫切需要提供一种坚固、低调的肌电假肢手指系统。致地址 针对这个需求，我们组建了协同开发团队，目前已经成功推出了六款设备，其中 已为超过 3,300 名上肢丧失患者进行过适配，并拥有丰富的监管经验， 获得两项 510(k) 批准和五个上肢假肢装置 CE 标志。在这样的背景下， 通过这个 Fast-Track SBIR 应用程序，我们的协作团队将开发并推出 Point Powered 系统：一种先进的机电假肢系统，适用于部分手部丧失的个体，其中包括 1) 强大的点供电数字； 2）低剖面肌电图电极； 3）多输入控制器； 4) 使用 iPad 的用户 接口和5）灵活的基于电池的电源系统。点供电系统将 1) 具有行业领先的 力量和速度，2) 提供围绕患者掌指骨 (MCP) 的解剖旋转和屈曲 关节，3) 具有三个解剖学上准确的关节，尺寸足够小，可以容纳 90% 以上的男性， 女性，4) 与未来复杂的控制策略兼容。 第一阶段，我们将完成三项主要任务：1）完成机电点的工作原型 供电数字、控制器、电极和用户界面 2) 以 5 人焦点小组进行迭代测试 患者和假肢师并验证组件级功能，3) 完成对组件的内部验证 点供电系统。这些任务的成功完成将推动项目进展到第二阶段。 在第二阶段，点供电系统将在两个目标上进行评估。第一个目标，我们将完成第三方 验证以确保符合医疗器械标准，我们将在 为我们的长期临床研究做准备。一旦验证和确认步骤完成，临床 将在 10 名部分失手的参与者中进行试验，根据他们的标准来评估该系统 护理治疗。在这些研究结束时，我们将确定设备的安全性和有效性 并将提交 510(k) 上市前许可申请。 Point Powered 是我们的长期目标 该系统将通过增强部分手部截肢者的能力来实现高度的临床影响。