Surgical technique for installing an eight-channel neuroprosthesis for standing.

Abstract

A standardized surgical procedure to implant an eight-channel functional neuromuscular stimulation system in the lower extremities for standing, exercise, and transfers for individuals with spinal cord injury has been developed. The implanted components include: (1) one eight-channel receiver-stimulator, (2) epimysial electrodes, (3) intramuscular electrodes, and (4) inline connectors. The development process included identifying the target muscle set for electrode placement and the corresponding surgical approaches, determining the stages of the surgical procedure, and assessing the effectiveness and stability of the implanted neuroprosthesis. The bilateral muscle set consists of the vastus lateralis, the gluteus maximus, the semimembranosus, and the erector spinae. Surgical approaches to the nerve entry points were developed through a series of cadaveric studies and intraoperative tests. Electrode placement is related to bony landmarks and based on standard orthopaedic approaches. The components of the neuroprosthesis are installed in one surgical session, with three stages. This procedure has been applied successfully in seven individuals, resulting in strong, isolated stimulated contractions adequate to raise and lower the body, maintain standing with a walker, and perform pivot transfers. The standardized surgical procedure is repeatable and teachable and will be used in upcoming multicenter clinical trials of the implanted neuroprosthesis.