Clinical Validation of Myoelectric Implant for Intuitive Prosthesis Control

摘要 这个翻译的NIH SBIR计划的目标是评估一个小型的、可植入的记录系统 前臂截肢患者残馀肌肉的肌电信号。信号将会是无线的 耦合到用于控制假体的外部收发机。与传统的表面电极相比， 该系统将提供： ·从残肢的大量肌肉中获得更多的假肢控制渠道， ·提高了单个肌肉和肌群记录的特异性和可重复性， ·在不同插座条件下记录的信号具有更高的可靠性和质量， ·来自深部肌肉的选择性、一致的信号，以及 ·能够使用凝胶、真空和其他不易容纳的假体套筒衬里系统 表面电极。 这些多通道记录将使用户能够生成同时的多轴运动， 与一次只能驱动一个关节轴的现有肌肉控制器相比，它具有自然的控制感。在第一阶段，我们 将完成外部收发器的升级和测试，以消除对佩带处理器的需求。 在第二阶段，我们会与匹兹堡大学合作进行一项初步的可行性研究。我们会 与Advanced ARM Dynamic协调全国招生，招收足够数量的科目 对5名受试者植入肌电种植体进行为期1年的研究。受试者将被植入并接受 在匹兹堡大学进行的为期一年的带回家的研究中进行的季度评估。植入物将会是 评价控制多关节假肢的安全性和有效性。

Abstract The goal of this translational NIH SBIR program is to evaluate a small, implantable system for recording myoelectric signals from residual muscles of individuals with forearm amputations. The signals will be wirelessly coupled to an external transceiver for controlling a prosthesis. Compared to conventional surface electrodes, this system will provide: • more channels for prosthesis control from a larger number of muscles in the residual limb, • improved specificity and repeatability for recording from individual muscles and muscle groups, • higher reliability and quality for the recorded signals under different socket conditions, • selective, consistent signals from deep muscles, and • the ability to use gel, vacuum, and other prosthesis socket lining systems that do not easily accommodate surface electrodes. These multichannel recordings will enable users to generate simultaneous multi-axis movements with a more natural feel of control than existing myocontrollers that only actuate a single joint axis at a time. In Phase I, we will complete upgrades and testing of the external transceiver to eliminate the need of the belt-worn processor. In Phase II, we will conduct an early feasibility IDE study in conjunction with the University of Pittsburgh. We will coordinate nationwide recruitment along with Advanced Arm Dynamics to enroll a sufficient number of subjects to implant 5 subjects with the myoelectric implant for a 1-year study. Subjects will be implanted and undergo quarterly evaluation at the University of Pittsburgh throughout the 1-year take-home study. The implant will be evaluated for safety and efficacy for controlling a multi-articulating prosthetic limb.