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.
The implantable myoelectric sensor produced in this program will provide fundamental improvements in the usability and reliability of prosthetic arms, wrists, and hands. The multi-channel recordings provided by the system will also enable prostheses to produce coordinated, multi-joint movements with a more intuitive, natural feel of control for the user. In the long term, this technology may also help improve outcomes for pediatric prosthesis users by enabling systems that are simpler to learn during critical neurological development periods.