Implantable Myoelectric Recording Array for Control of Prostheses

描述(由申请人提供)：这个翻译的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馀和重新支配的肌肉的肌电信号。这些信号将被无线耦合到外部接收器，用于控制假肢。与传统的表面电极相比，该系统将提供：7从残肢中更多的肌肉控制假体的通道，7从单个肌肉和肌肉组记录的特异性和重复性，7在不同插座条件下记录的信号的更高的可靠性和质量，7来自深层肌肉的选择性、一致的信号，特别是在目标再神经使用者中，以及7能够使用凝胶、真空和其他不容易容纳表面电极的假体插座衬里系统。这些多通道记录还将使用户能够产生同时的多轴运动，与现有的一次仅驱动一个关节轴的肌肉控制器相比，具有更自然的控制感。在第一阶段，我们将进行概念验证动物实验，以验证电极和电子设计。我们将比较植入的原型系统传输的无线多通道肌电信号和标准的经皮肌电有线系统在狗的跑步机行走时的信号。在第二阶段，我们将完成植入物、外部部件和相关消毒包装的开发。在第二阶段计划结束时，该系统将被提交给集成开发环境，以便在第三阶段在一小部分前臂截肢患者中进行试点临床研究。 公共卫生相关性：该项目生产的植入式肌电传感器将从根本上改善假肢、手腕和手的可用性和可靠性。该系统提供的多通道记录还将使假肢能够产生协调的多关节运动，为用户提供更直观、更自然的控制感。从长远来看，这项技术还可能通过使系统在关键的神经发育时期更容易学习来帮助改善儿科假体使用者的预后。

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. PUBLIC HEALTH RELEVANCE: The implantable myoelectric sensor produced in this program will provide fundamental improvements in the usability and reliability of prosthetic arms, wrists, and hands. The multi-channel recordings provided by the system will also enable prostheses to produce coordinated, multi-joint movements with a more intuitive, natural feel of control for the user. In the long term, this technology may also help improve outcomes for pediatric prosthesis users by enabling systems that are simpler to learn during critical neurological development periods.