Fully implanted system for upper limb myoelectric prosthesis control

描述（由申请人提供）： 该项目将在3名退伍军人中部署完全植入的肌电信号（MES）采集系统，用于控制经桡（肘部以下）截肢者的先进灵巧假手和手腕。一种新的MES控制器算法的基础上的时间延迟的神经网络和概率自适应滤波器，选择性地抑制非预期的运动命令将允许同时和连续控制的多个运动所提供的先进的假体。植入式MES采集系统将使用一个新的器械系列，包括植入式电池、植入式放大器和模数转换器以及植入式遥测系统。这种植入的MES采集系统将提供来自肢体中任何剩余肌肉的高度选择性和高度可重复的MES记录，即使是那些位于肢体深处或不直接位于关节窝下方的肌肉。植入的肌内电极可以针对任何肌肉调整尺寸，将牢固地锚定在肌肉内，并且不需要用户进行任何穿戴。植入的MES采集系统将使用行业标准MedRadio协议与安装在假肢上的小型外部"集线器"进行无线通信。外部集线器接收MES信号，执行新的MES控制器算法，然后与假体的控制总线接口，以命令其各种关节运动。 控制器算法最初将使用临时细钢丝EMG电极记录和虚拟假体模拟器开发，其中10名截肢参与者将执行模拟功能任务。在这些实验中使用的肌肉信号将被改变，以确定哪些肌肉提供用于控制的最佳MES信号，最终系统中将需要多少肌肉，以及估计最终系统的预期性能。同时，将使用内置MedRadio遥测和微控制器的小型商业器械实现外部集线器，以实现高级控制器算法，并获得监管批准（美国食品药品监督管理局和当地机构审查委员会的试验用器械豁免）。然后将永久性系统（植入MES系统、具有高级控制算法的外部集线器、灵巧的商业上肢肌电假肢）集成并在3名经桡动脉截肢的个体中实现。广泛的技术评估将证明系统组件的性能。一系列广泛的临床评估将比较用户的"护理标准"假体控制系统（通常是带有状态控制器的基于表面EMG的记录）与本项目开发的新植入MES-高级控制器算法方法的功能性能。 拟议的工作与VA康复研究和发展服务的战略计划直接一致，是对美国国防高级研究计划局（DARPA）和几家商业假肢制造商最近开发的复杂和灵巧的上肢假肢的一个很好的补充。所提出的完全植入式MES采集系统和先进的控制器算法将提供实现这些先进上肢假肢的潜力所需的更丰富的命令信息。虽然最初针对的是经桡动脉截肢的个体，但这种相同的基本方法（即，具有高级控制器的植入式MES）在未来广泛适用于其他退伍军人截肢者群体，包括经肱骨、部分手、肩关节离断和下肢截肢者。靶向肌肉神经再支配（TMR），另一种先进的假肢控制方法，也可以大大提高使用这里提出的技术。因此，拟议的系统有可能真正彻底改变假肢师和假肢用户对肌电控制的看法! 公共卫生相关性： 长期以来，减少肢体丧失的功能后果一直是VA康复研究和发展服务的主要重点。最近，1000多名士兵从伊拉克和阿富汗的当前行动中截肢返回，VA RR & D服务优先进行研究，使假肢能够提供接近受伤前水平的功能。几乎与自然人手臂的机械性能相匹配的先进假肢开始从联邦研究项目和商业制造商中出现，但使用者控制这些假肢的方式仍然太笨拙和不可靠。该项目将开发一种新的方法，使截肢者能够控制他们的假肢，基本上就像他们控制他们的自然手臂一样。这种新系统将通过手术植入，因此在使用过程中，除了假肢之外，不需要戴上任何东西，它提供的控制质量将始终相同。该系统最终可以与几乎任何肌电或动力假肢一起工作。

DESCRIPTION (provided by applicant): This project will result in the deployment of a fully implanted myoelectric signal (MES) acquisition system in 3 veterans that is used to control advanced dexterous prosthetic hands and wrists for individuals with transradial (below elbow) amputations. A novel MES controller algorithm based on a time-delayed neural network and a probabilistic adaptive filter that selectively suppresses unintended movement commands will allow simultaneous and continuous control of the multiple motions provided by the advanced prosthesis. The implanted MES acquisition system will use a new family of devices that include an implanted battery, implanted amplifiers and analog-to-digital converters, and an implanted telemetry system. This implanted MES acquisition system will provide highly selective and highly repeatable MES recordings from any remaining muscle in the limb, even those located deep within the limb or not located directly underneath the socket. The implanted intramuscular electrodes can be sized for any muscle, will be firmly anchored within the muscles, and do not require any donning by the user. The implanted MES acquisition system will communicate wirelessly with a small external "hub" that is mounted inconspicuously on the prosthetic limb using the industry standard MedRadio protocol. The external hub receives the MES signals, implements the new MES controller algorithm, and then interfaces with the control bus of the prosthesis to command its various joint motions. The controller algorithm will be initially developed using temporary fine-wire EMG electrode recordings and a virtual prosthesis simulator in which 10 amputee participants will perform simulated functional tasks. The muscle signals used in these experiments will be varied to determine which muscles provide the best MES signals for control, how many muscles will be needed in the final system, and to estimate the expected performance of the final system. In parallel, the external hub will be realized using a small commercial device with built-in MedRadio telemetry and a microcontroller for implementing the advanced controller algorithm, and regulatory approvals (Investigational Device Exemption from the Food and Drug Administration and local Institutional Review Board) will be obtained. The permanent system (implanted MES system, external hub with advanced control algorithm, dexterous commercial upper limb myoelectric prosthesis) will then be integrated and realized in 3 individuals with transradial amputations. Extensive technical assessments will demonstrate the performance of the system components. An extensive battery of clinical assessments will compare the functional performance of the user's "standard of care" prosthesis control system (typically surface EMG-based recordings with a state controller) to that of the new implanted MES - advanced controller algorithm approach developed under this project. The proposed work is directly aligned with the strategic plan of the VA Rehabilitation Research and Development Service and is an excellent complement to the recent development of sophisticated and dexterous upper limb prostheses by the Defense Advanced Research Projects Agency (DARPA) and by several commercial prosthesis manufacturers. The proposed fully-implanted MES acquisition system and advanced controller algorithm will provide the much richer command information needed to realize the potential of these advanced upper limb prostheses. Although initially targeted to individuals with transradial amputations, this same basic approach (i.e., implanted MES with advanced controller) is broadly applicable to other veteran amputee populations in the future, including transhumeral, partial hand, shoulder disarticulation, and lower extremity amputees. Targeted muscle reinnervation (TMR), another advanced prosthesis control approach, could also be greatly enhanced by the use of the techniques proposed here. The proposed system thus has the potential to truly revolutionize the way that prosthetists and prosthesis users think about myoelectric control! PUBLIC HEALTH RELEVANCE: Reducing the functional consequences of limb loss has long been a major focus of the VA Rehabilitation Research and Development Service. Recently, more than 1000 soldiers have returned from current operations in Iraq and Afghanistan with amputations, and the VA RR&D Service has prioritized research to make prostheses capable of providing function approaching pre-injury levels. Advanced prostheses that nearly match the mechanical performance of natural human arms are beginning to emerge from federal research projects and from commercial manufacturers, but the way that users control these prostheses is still too awkward and unreliable. This project will develop a new approach that will allow amputees to control their prostheses in essentially the same way they would control their natural arm. This new system will be surgically implanted, so nothing other than the prosthesis will have to be put on during use, and the quality of control it provides will always be the same. This system could eventually work with almost any myoelectric or powered prosthesis.