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

摘要 在美国，大约有60万人生活在部分手部截肢的情况下， 每年都有新的病例发生。尽管在小型化电子设备和电机方面取得了进步， 对于这一服务不足的患者群体，机电假肢手指的进展非常小。事实上，到目前为止， 在美国只有一种用于部分手丧失的患者的肌电假肢选择。这种选择是脆弱的， 通常仅限于轻型任务，并且太大而不能用于大多数部分手损失的情况。考虑到这一点，这是没有 令人惊讶的是，只有不到一半的部分手缺失的人能够恢复到他们以前的状态， 就业，而那些这样做的人往往必须对其工作相关的任务作出相当大的改变。 因此，非常需要提供一种坚固的、低轮廓的肌电假肢手指系统。解决 为了满足这一需求，我们组建了一个合作开发团队，已经成功推出了六款设备， 已适用于超过3，300名上肢丧失患者，并具有丰富的监管经验， 获得了两项510（k）批准和五项上肢假肢设备的CE认证。在这样的背景下， 通过这个快速通道SBIR应用程序，我们的合作团队将开发和推出点动力 系统：一个先进的机电一体化假肢系统，适用于部分手丧失的个人，包括1） 强大的点供电数字; 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）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（MCP）的解剖旋转和屈曲 关节，3）具有三个解剖学上精确的关节，尺寸小到足以容纳超过90%的男性， 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）完成机电点的工作原型 电动手指、控制器、电极和用户界面2）进行迭代测试，焦点组为5人 患者和修复师，并验证组件级功能; 3）完成 点供电系统。成功完成这些任务将使项目进展进入第二阶段。 在第二阶段，将从两个目标对点供电系统进行评估。在第一个目标中，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， 将在10名部分丧失手部的参与者中进行试验， 护理治疗。在这些研究结束时，我们将确定器械的安全性和有效性 并将提交510（k）上市前许可申请。我们的长期目标是， 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。

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.