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

摘要 在美国，大约有60万人接受部分手截肢，估计有14500人 每年都有新的病例发生。尽管小型化的电子产品和马达取得了进步，但还是有 对于这一缺乏服务的患者群体来说，机电一体化假肢的进步微乎其微。事实上，到目前为止， 在美国，只有一种肌电假体可用于部分失手患者。这个选择是脆弱的， 通常仅限于轻型任务，并且太大而不能用于大多数部分手丢失的情况。考虑到这一点，这是没有的 令人惊讶的是，只有不到一半的部分失手患者能够恢复到以前的状态 就业，而那些这样做的人必须经常对其与工作有关的任务做出重大改变。 因此，很有必要提供一种健壮、低调的肌电假体数字系统。致信地址 在这种需求下，我们成立了一个协同开发团队，已经成功推出了六款设备，其中 曾为3,300多名上肢缺失患者提供服务，并拥有丰富的管理经验， 获得两项510(K)认证和五项上肢假肢装置CE认证。在这样的背景下， 通过这款Fast-Track SBIR应用程序，我们的协作团队将开发和推出Point Powered 系统：先进的机电一体化假肢系统，适用于部分失手患者，包括1) 健壮的点供电数字；2)薄型肌电电极；3)多输入控制器；4)iPad用户 接口和5)灵活的基于电池的电源系统。POINT POWER系统将拥有行业领先地位 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)有三个解剖上准确的关节和足够小的尺寸，足以容纳90%以上的男性和 女性，以及4)与未来复杂的控制策略相适应。 在第一阶段，我们将执行三项主要任务：1)完成机电点的工作原型 带电源的数字、控制器、电极和用户界面2)以5人为焦点组进行迭代测试 患者和修复师并验证组件级功能，以及3)完成内部验证 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，点动力系统将在两个目标下进行评估。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，临床 将对10名部分手失手的参与者进行试验，以评估他们的标准- 关爱治疗。在这些研究的结论中，我们将确定这些装置的安全性和有效性 并将提交510(K)计划的上市前许可申请。Point为我们提供动力是我们的长期目标 该系统将通过赋予部分手部截肢者权力，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.