Development of an Implantable EMG Micro-Telemeter

植入式肌电图微型遥测仪的开发

• 批准号: 6994036
• 负责人: DAVID J EDELL
• 金额: $ 39.61万
• 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 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6994036
• 关键词: bioengineering /biomedical engineering; biomedical equipment development; clinical biomedical equipment; clinical research; electromyography; human subject; implant; laboratory rabbit; medical implant science; miniature biomedical equipment; muscle function; patient monitoring device; skeletal prosthesis; telemetry

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，如钳子（手），肘部或腕部。这些通常是由来自一对皮肤表面电极的电信号或肌电图（emg）控制的。被控制的关节通常是通过同时拉紧两块肌肉来选择的，这使得控制器改变功能。由于皮肤电极固有的噪声和稳定性问题，以及小的、紧密间隔的、经常萎缩的肌肉的有限活动区域，很难从皮肤表面电极获得肌电控制信号。对于肘部以下截肢者，如果有多个高质量控制信号来源，可以同时控制多个动力关节（即手腕、拇指、手指）。通过植入肌电遥测仪来接触所有的残余肌肉，高质量的控制信号可以同时从许多肌肉传输到多功能，灵巧的假体。第一阶段项目成功地展示了利用光学遥测技术对长期植入的兔子的低噪声肌电信号进行遥测。拟建二期项目进行临床应用和商业化。首先，这项技术将作为一种非侵入性设备进行完善和测试，为具有特定类型插座的患者建立产品，并展示这项技术的好处。遥测仪将嵌入在滚上硅胶套，以消除繁琐的卡扣式接线。对于更传统的假体悬浮物，遥测仪将粘附在皮肤上，以消除假体外壳电极在皮肤上运动所引起的电噪声。设备将通过蒸汽灭菌循环、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，在这项技术在非侵入性测试中被证明是可靠和有效的之后，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外，还将演示由肘部以下截肢者同时控制多个致动器。在此期间，将寻求监管部门的最终批准，并在有限的基础上开始上市。