Implantable Myoelectric Recording Array for Control of Prostheses

描述（由申请人提供）：这个转化SBIR项目的目标是创建一个小型的可植入系统，用于记录前臂和其他截肢患者的残余和再神经支配肌肉的肌电信号。这些信号将被无线连接到一个外部接收器上，用于控制假肢。与传统的表面电极相比，该系统将提供：7 .更多的通道用于来自更多残肢肌肉的假肢控制；7 .提高了单个肌肉和肌群记录的特异性和可重复性；7 .不同窝形条件下记录信号的可靠性和质量更高；7 .来自深层肌肉的选择性、一致性信号，特别是针对目标神经移植用户；7 .使用凝胶、真空、以及其他不容易容纳表面电极的假体插座内衬系统。这些多通道记录还将使用户能够同时产生多轴运动，比现有的肌控制器一次只驱动单个关节轴的控制感更自然。在第一阶段，我们将进行概念验证动物研究，以验证电极和电子设计。我们将比较由植入的原型系统传输的无线多通道肌电信号与标准的经皮有线肌电信号在狗在跑步机上行走时的情况。在第二阶段，我们将完成植入物、外部组件和相关灭菌包装的开发。在II期项目结束时，该系统将提交IDE，在一小部分前臂截肢者中进行III期试点临床研究。

DESCRIPTION (provided by applicant): The goal of this translational SBIR program is to create a small, implantable system for recording myoelectric signals from residual and reinnervated muscles of individuals with forearm and other amputations. The signals will be wirelessly coupled to an external receiver for controlling prostheses. Compared to conventional surface electrodes, this system will provide: 7 more channels for prosthesis control from a larger number of muscles in the residual limb, 7 improved specificity and repeatability for recording from individual muscles and muscle groups, 7 higher reliability and quality for the recorded signals under different socket conditions, 7 selective, consistent signals from deep muscles, especially in targeted reinnervation users, and 7 the ability to use gel, vacuum, and other prosthesis socket lining systems that do not easily accommodate surface electrodes. These multichannel recordings will also 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 conduct a proof-of-concept animal study to validate the electrode and electronics design. We will compare the wireless multichannel EMG signals transmitted by an implanted prototype system to a standard percutaneous EMG wired system in canines during treadmill walking. In Phase II, we will complete the development of the implant, the external components, and the associated packaging for sterilization. At the end of the Phase II program, the system will be submitted for an IDE for a pilot clinical study in a small population of forearm amputees in Phase III.