Regulatory clearance of the Glide Control Strategy for Upper Limb Prostheses

上肢假肢滑动控制策略的监管许可

• 批准号: 10603007
• 负责人: Rahul Reddy Kaliki
• 金额: $ 87.33万
• 依托单位: INFINITE BIOMEDICAL TECHNOLOGIES, LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-17 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10603007
• 关键词: Affect; Amputees; Architecture; Artificial Arm; Calibration; Caring; Clinical; Clinical Research; Data; Development; Devices; Documentation; Electrodes; Engineering; Ensure; Experimental Designs; Goals; Healthcare; Individual; Intuition; Joystick; Limb Prosthesis; Location; Marketing; Measurement; Measures; Medical; Medical Device; Methods; Motion; Movement; Myoelectric prosthesis; Occupational Therapist; Outcome; Participant; Patients; Pattern Recognition; Performance; Phase; Positioning Attribute; Production; Productivity; Prosthesis; Prosthetic rehabilitation; Provider; Quality of life; Questionnaires; Radial; Rehabilitation Outcome; Rehabilitation therapy; Research; Specific qualifier value; System; Technology; Testing; United States Food and Drug Administration; Upper Extremity; Validation; Work; clinical care; clinically relevant; commercialization; design; evidence base; experience; fabrication; functional outcomes; grasp; home test; improved; individual patient; innovation; limb loss; myoelectric control; novel; prosthesis control; prosthetic hand; rehabilitative care; residual limb; satisfaction; usability; vector; verification and validation

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.

上肢假体滑动控制策略的监管许可 摘要 有一个迫切的需要，以改善控制肌电假肢的个人上肢损失（截肢）。 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， 1960年推出）和模式识别（PR，2016年推出）。两者都有很大的局限性， 在提案中提出。 因此，我们提出了一种新的控制方法称为滑翔。Glide架构不使用“触发器”来切换 它可以像DC系统一样在不同的抓取之间进行调整，也不像PR系统那样需要频繁的“重新校准”。相反地， 它结合了DC的简单性和PR的功能性。 将“滑翔光标”移动到称为“滑翔域”的圆形区域内的特定位置。的 滑动光标位置由2到8个EMG通道的矢量和的结果确定 （取决于个体患者的需要），其中每个电极通道以相等的角度间隔开， 在滑翔域上彼此相隔的距离 到目前为止，我们已经1）开发了控制器硬件; 2）迭代开发了控制策略和用户 与临床医生和患者直接接触; 3）共评估了9名患者 其中包括7名完成了长期家庭测试的经桡动脉造影患者。值得注意的是，我们现在的经验 包括一名已使用该系统两年半的个人。 我们现在建议将新的Glide控制策略商业化，并使最广泛的群体能够获得 患者可能。我们提出两个目标来实现这些目标。第一个目标是监管目标， 我们将完成系统的验证和确认，并提交510（k）申请监管批准。的 第二个目标是科学目标，我们将评估使用Glide导致改善 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 这个目的，如果效果好的话，就是给报销提供有力的支持。 如果我们成功了，我们将完成我们的双重任务-提高上肢假肢的可用性， 同时增加现实世界对先进假肢技术的使用。