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）：现代电动假肢的功能仅限于一次驱动 1 个动力关节，例如钳子（手）、肘部或腕部。这些通常由一对皮肤表面电极的电信号或肌电图 (EMG) 控制。最常见的是通过同时拉紧两块肌肉来选择被控制的关节，这会导致控制器改变功能。由于皮肤电极固有的噪声和稳定性问题，以及小而紧密且经常萎缩的肌肉的活动区域有限，因此很难从皮肤表面电极获取肌电控制信号。对于肘部以下截肢者，如果有多个高质量控制信号源，则可以同时控制多个动力关节（即手腕、拇指、手指）。通过植入肌电图遥测仪来访问所有剩余肌肉，高质量的控制信号可以同时从许多肌肉传输到多功能、灵巧的假肢。第一阶段项目成功演示了使用光学遥测技术获取功率和信号的长期植入兔子的低噪声肌电图信号遥测。拟开展临床应用和商业化二期项目。首先，该技术将作为非侵入性设备进行完善和测试，为具有某些类型插座的患者建立产品，并展示该技术的好处。遥测仪将嵌入滚式硅胶套中，以消除繁琐的卡扣式接线。对于更传统的假肢悬架，遥测仪将粘附在皮肤上，以消除因假肢外壳电极在皮肤上移动而产生的电噪声。设备将通过蒸汽灭菌周期、长期盐水浸泡、长期动物植入、截肢者实验室评估任务和家庭试验进行评估。第二个目标是，在非侵入性测试中证明该技术可靠且功能齐全后，我们将在截肢志愿者身上植入设备，他们将从这种方法中受益最多。除了工程测量和评估之外，还将演示肘部以下截肢者对多个执行器的同时控制。在此期间，将寻求最终的监管批准，并且市场将在有限的基础上开始。