Development of an Implantable EMG Micro-Telemeter

植入式肌电图微型遥测仪的开发

• 批准号: 7127716
• 负责人: DAVID J EDELL
• 金额: $ 40.89万
• 依托单位: INNERSEA TECHNOLOGY, INC
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-15 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7127716
• 关键词: Development; Implantable; EMG; Micro; Telemeter

DESCRIPTION: (provided by applicant): The function of modern electrically powered prostheses is limited to actuation of 1 powered joint at a time such as a pincer (hand), elbow, or wrist. These are most often controlled by electrical signals or ElectroMyoGrams (EMGs) from a pair of skin surface electrodes. The joint being controlled is most commonly selected by tensing both muscles simultaneously which causes the controller to change function. EMG control signals are difficult to acquire from skin surface electrodes because of the intrinsic noise and stability problems of skin electrodes, and the limited active areas of small, closely spaced, and often atrophied muscles. For below-elbow amputees, simultaneous control of multiple powered joints (i.e. wrist, thumb, fingers) could be accomplished if multiple sources of high quality control signals were available. By implanting EMG telemeters to access all residual muscles, high quality control signals can be transmitted simultaneously from many muscles to a multi-functional, dexterous prosthesis. The Phase-1 project successfully demonstrated telemetry of low noise EMG signals from a chronically implanted rabbit using optical telemetry for power and signal. A Phase-2 project is proposed for clinical application and commercialization. First, the technology will be perfected and tested as a non-invasive device to establish a product for patients with certain types of sockets and to demonstrate the benefits of this technology. Telemeters will be embedded in roll-on silicone sleeves to eliminate the cumbersome snap-on wiring. For more traditional prosthesis suspensions, the telemeters will be adhered to the skin to eliminate electrical noise caused by movement of the prosthesis shell electrodes over the skin. Devices will be evaluated through steam sterilization cycles, in long term saline soak, long term animal implants, amputee laboratory evaluation tasks and home trials. The second goal, after the technology is proven reliable and functional in the non-invasive testing, we will be to implant devices in amputee volunteers who will benefit most from this approach. In addition to engineering measures and evaluations, simultaneous control of multiple actuators by a below elbow amputee will be demonstrated. During this time final regulatory approval will be sought and marketii begiaon a limited basis.

描述：（由申请人提供）：现代电动假体的功能仅限于一次促使1个电力关节的致动，例如钳子（手），肘部或手腕。这些通常是由一对皮肤表面电极的电信号或肌电图（EMG）控制的。控制关节是通过同时张紧两种肌肉来选择的，从而导致控制器改变功能。由于皮肤电极的固有噪声和稳定性问题，以及小的，紧密的肌肉且通常是萎缩的肌肉，由于固有的噪声和稳定性问题，EMG控制信号很难从皮肤表面电极中获取。对于低于肘部的截肢者，如果有多个高质量控制信号的来源，可以同时控制多个动力接头（即手腕，拇指，手指）。通过植入EMG遥测器以获取所有残留肌肉，高质量控制信号可以同时从许多肌肉传播到多功能，灵活的假体。第1阶段项目成功地证明了使用光学遥测的功率和​​信号从长期植入的兔子那里从慢性植入的兔子发出的低噪声EMG信号的遥测。提出了用于临床应用和商业化的2期项目。首先，该技术将被完善和测试，作为一种非侵入性设备，以为具有某些类型插座的患者建立产品并证明该技术的好处。遥测器将嵌入滚动硅胶套筒中，以消除笨拙的快照接线。对于更传统的假体悬浮液，遥测器将被粘附在皮肤上，以消除由皮肤上的假体壳电极移动引起的电噪声。设备将通过蒸汽灭菌周期进行评估，长期盐水浸泡，长期动物植入物，截肢实验室评估任务和家庭试验。第二个目标是在该技术在非侵入性测试中可靠且功能性之后，我们将是在截肢者志愿者中的植入设备，这些志愿者将从这种方法中受益最大。除工程措施和评估外，还将证明通过肘部截肢者同时控制多个致动器。在此期间，将寻求最终的监管批准，并有限地市场上的Begiaon。