Implantable Myoelectric Recording Array for Control of Prostheses

用于控制假肢的植入式肌电记录阵列

• 批准号: 8693030
• 负责人: Daniel McDonnall
• 金额: $ 100万
• 依托单位: RIPPLE, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2017-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8693030
• 关键词: Amplifiers; Amputation; Amputees; Animal Experimentation; Animals; Back; Canis familiaris; Childhood; Clinical Research; Coupled; Coupling; Development; Devices; Electrodes; Electromagnetics; Electronics; Forearm; Gel; Goals; Hand; Implant; In Vitro; Individual; International; Joints; Learning; Limb structure; Marketing; Measurement; Medical Device; Modeling; Movement; Muscle; Neurologic; Noise; Outcome; Phase; Population; Prostheses and Implants; Prosthesis; Residual state; Rest; Signal Transduction; Skin; Small Business Innovation Research Grant; Specificity; Sterilization; Surface; System; Technology; Telemetry; Time; Universities; Utah; Vacuum; Walking; Wireless Technology; Wrist; arm; base; design; electric impedance; improved; in vivo; joint mobilization; meetings; operation; performance tests; programs; prototype; reinnervation; sensor; usability

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.

描述（由申请人提供）：该转化性 SBIR 项目的目标是创建一个小型植入式系统，用于记录来自前臂和其他截肢者的残余和重新神经支配的肌肉的肌电信号。这些信号将无线耦合到外部接收器以控制假肢。与传统的表面电极相比，该系统将提供： 7 个更多的通道，用于来自残肢中更多肌肉的假肢控制； 7 提高了记录单个肌肉和肌肉群的特异性和可重复性； 7 不同插座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、一致的信号，特别是针对目标神经再支配用户；7 能够使用凝胶、真空和其他技术。 假肢接受腔衬里系统不易容纳表面电极。这些多通道记录还将使用户能够生成同步多轴运动，与一次仅驱动单个关节轴的现有肌肉控制器相比，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研究，以验证电极和电子设计。我们将在跑步机行走期间将植入原型系统传输的无线多通道肌电图信号与犬科动物的标准经皮肌电图有线系统进行比较。在第二阶段，我们将完成植入物、外部组件以及相关灭菌包装的开发。在第二阶段计划结束时，该系统将提交给 IDE，以便在第三阶段对一小部分前臂截肢者进行试点临床研究。