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60万人患有部分手动截肢，估计有14,500人 新案件每年发生。尽管微型电子和电动机取得了进步，但 对于这个服务不足的患者人群，机器人假肢数字的进步很少。实际上，迄今为止 在美国有部分手损失的患者只有一种肌电假体选择。此选项很脆弱， 通常仅限于轻度任务，并且太大，无法在大多数部分手部损失案例中使用。考虑到这一点，没有 令人惊讶的是，只有一半的人缺席的人能够返回以前的 就业，以及那些经常考虑对工作相关的任务进行更改的人。 这是非常需要提供强大，低调的肌电假肢系统的。解决 这种需求，我们组成了一个协作开发团队，该团队已成功启动了六个设备，该设备 适合3300多名上肢损失的患者，并具有大量的调节经验， 在上肢假体设备上获得了两个510（k）批准和五个CE标记。在这个背景下， 通过此快速跟踪SBIR应用程序，我们的协作团队将开发并启动该点的动力 系统：针对部分手损失的个体的高级机电假体系统，其中包括1） 强大的点驱动数字； 2）低剖面EMG电极； 3）多输入控制器； 4）基于iPad的用户 接口和5）基于电池的灵活电源系统。点驱动系统将1）具有行业领先 强度和速度，2）在患者的掌pophangeal（MCP）周围提供解剖旋转和屈曲 关节，3）具有三个解剖学精确的关节，大小很小，足以容纳90％以上的男性和 妇女和4）与未来复杂的控制策略兼容。 在第一阶段，我们将执行三个主要任务：1）机电点的完整工作原型 动力数字，控制器，电极和用户界面2）用5个焦点组执行迭代测试 患者和假肢，并验证组件级功能以及3）完整的内部验证 点驱动系统。这些任务的成功完成将使项目的进度登上第二阶段。 在第二阶段，将以两个目的评估点驱动系统。在第一个目标中，我们将完成第三方 验证以确保符合医疗设备标准，我们将在 为我们的长期临床研究做准备。验证和验证步骤完成后，临床 将进行试验，以评估10名参与者的系统，其中部分手损失与其标准标准 护理治疗。在这些研究结束时，我们将确定设备的安全性和效率 并将提交510（k）申请上市批准。这是我们的长期目标是动力 系统将通过赋予部分手动截距的能力来实现高度的临床影响。