A fully implanted intramuscular bipolar myoelectric signal recording electrode.

Objectives: The objective of this study is to develop a fully implanted, intramuscular, bipolar, myoelectric signal (IM-MES) recording electrode for functional electrical stimulation (FES), prosthetic myoelectric control, and other permanently implantable systems.

Materials And Methods: An existing fully implanted intramuscular stimulating electrode was modified at each end to allow bipolar recording. The design change also required a modification of the implantation method. Mechanical and in vivo testing was performed on the novel components of the electrode. The first clinical application also is described.

Results: The electrode design modifications did not create any areas of excess mechanical strain on the wires at the distal end where the leads were wound into electrode surfaces. In vivo testing showed that the IM-MES electrode recorded myoelectric signals that were equivalent to an existing epimysial MES electrode. The modified implantation method was simple to implement. The IM-MES electrode was used in an upper extremity FES system in an individual with a spinal cord injury and provided signals that were suitable for a command signal.

Conclusions: A fully implanted, bipolar intramuscular recording electrode (IM-MES) was developed. Implantation of the IM-MES is straightforward, and almost any muscle can be targeted. Testing has been performed to demonstrate the suitability of the IM-MES electrode for clinical use. Initial clinical applications were successful.