Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses

上肢假体滑动控制策略的监管许可 摘要 目前迫切需要改善对上肢丧失患者的肌电假体的控制。 到目前为止，只有两种基本的控制方法已经商业化--直接控制(DC， 和模式识别(PR，于2016年推出)。两者都有很大的局限性，因为 提案中概述了这一点。 因此，我们提出了一种新的控制方法--滑动控制。Glide架构不使用“触发器”来切换 在不同的抓取之间，如DC系统，也不需要像公关系统那样频繁的“重新校准”。相反， 它结合了DC的简单性和PR的功能。它基于实现操纵杆样式的运动 剩余肢体将“滑动光标”移动到称为“滑动区域”的圆形区域内的特定位置。这个 滑动光标位置由两到八个肌电通道的矢量求和的结果确定 (取决于个别患者的需要)，其中每个电极通道以等角度间隔 在Glide域上彼此之间的距离。 到目前为止，我们已经开发了控制器硬件；2)迭代开发了控制策略和用户 与临床医生和ULL患者直接参与的接口；以及3)总共评估了9名患者 其中包括7名完成长期居家测试的患者。值得注意的是，我们现在的经验 包括一名已经使用该系统两年半并在继续使用的个人。 我们现在提议将新的滑翔控制策略商业化，并使最广泛的群体能够访问 尽可能多的病人。为了实现这些目标，我们提出了两个目标。第一个目标是监管目标，其中 我们将完成系统的验证和确认，并提交510(K)供监管部门批准。这个 第二个目标是一个科学目标，我们将评估使用Glide会带来改善的假设 与使用标准DC假体相比，功能、满意度和使用指标。一个重要的好处 这一目标的目的，假设结果是有利的，是它将提供强有力的支持偿还。 如果我们成功了，我们将完成我们的双重使命-提高上肢假体的可用性，同时 同时增加现实世界获得先进假肢技术的机会。

Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses ABSTRACT There is a pressing need to improve control of myoelectric prostheses for individuals with upper limb loss (ULL). To date, only two fundamental control methods have been made commercially available – Direct Control (DC, introduced in 1960) and Pattern Recognition (PR, introduced in 2016). Both have significant limitations, as outlined within the proposal. Thus, we propose a new control method called Glide. The Glide architecture does not use ‘triggers’ to switch between different grasps like DC systems, nor does it require frequent ‘recalibration’ like PR systems. Instead, it combines the simplicity of DC with the functionality of PR. It is based on effecting joystick-style motions of the residual limb to move a “Glide cursor” to specific locations within a circular region called the “Glide domain.” The Glide cursor position is determined by the resultant of the vector summation of two to eight EMG channels (depending on individual patient’s needs), where each of the electrode channels are spaced at equal angular distances apart from each other on the Glide domain. To date, we have 1) developed the controller hardware; 2) iteratively developed the control strategy and user interface with direct involvement of clinicians and individuals with ULL; and 3) evaluated a total of nine individuals with trans-radial ULL including seven who completed long-term in-home testing. Of note, our experience now includes one individual who has been using the system for two and half years and counting. We now propose to commercialize the novel Glide control strategy and enable accessibility to the widest group of patients possible. We propose two aims to accomplish these goals. The first aim is a regulatory aim, where we will complete the Verification and Validation of the system and submit a 510(k) for regulatory approval. The second aim is a scientific aim, where we will evaluate the hypothesis that use of Glide results in improved functional, satisfaction and usage metrics as compared to use of a standard DC prosthesis. An important benefit of this aim, presuming the results are favorable, is that it will provide strong support for reimbursement. If we are successful, we will have met our dual mandate – to improve usability of upper limb prostheses, while simultaneously increasing real-world access to advanced prosthetic technologies.