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.

产品说明：（申请人提供）：现代电动假肢的功能仅限于一次驱动一个动力关节，如钳子（手）、肘部或手腕。这些通常由来自一对皮肤表面电极的电信号或肌电图（EMG）控制。被控制的关节通常是通过同时拉紧两块肌肉来选择的，这会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、紧密间隔的并且经常萎缩的肌肉的有限活动区域，EMG控制信号难以从皮肤表面电极获取。对于肘部以下截肢者，如果多个高质量控制信号源可用，则可以实现对多个动力关节（即手腕、拇指、手指）的同时控制。通过植入EMG遥测仪以访问所有剩余肌肉，可以将高质量的控制信号从许多肌肉同时传输到多功能灵巧的假肢。第一阶段项目成功地证明了使用光学遥测技术对功率和信号进行遥测，可以从长期植入的家兔中遥测低噪声EMG信号。拟开展2期临床应用和商业化项目。首先，该技术将作为一种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一种产品，并证明该技术的好处。遥测仪将嵌入在滚动硅胶套，以消除繁琐的卡扣布线。对于更传统的假体悬挂，遥测器将粘附到皮肤上以消除由假体外壳电极在皮肤上的移动引起的电噪声。将通过蒸汽灭菌周期、长期盐水浸泡、长期动物植入、截肢者实验室评价任务和家庭试验对器械进行评价。第二个目标是，在非侵入性测试中证明该技术可靠且有效后，我们将在截肢志愿者中植入设备，他们将从这种方法中受益最多。除了工程措施和评估，同时控制多个执行器的肘部以下截肢者将被证明。在此期间，将寻求最终的监管批准，并在有限的基础上开始上市。