Volume 40 Number 6, November/December 2003
Pages 457 — 468
Durability of implanted electrodes and leads in an upper-limb neuroprosthesisKevin L. Kilgore, PhD; P. Hunter Peckham, PhD; Michael W. Keith, MD; Fred W. Montague, MS;
Ronald L. Hart, MS; Martha M. Gazdik, BS; Anne M. Bryden, OTR/L; Scott A. Snyder, PhD;
Thomas G. Stage, BSDepartment of Orthopaedics, MetroHealth Medical Center, Cleveland, OH; Department of Biomedical Engineering, Case Western Reserve University, Cleveland, OH; Department of Veterans Affairs, Rehabilitation Research and Development Service, Cleveland, OHAbstract — Implanted neuroprosthetic systems have been successfully used to provide upper-limb function for over 16 years. A critical aspect of these implanted systems is the safety, stability, and reliability of the stimulating electrodes and leads. These components are (1) the stimulating electrode itself, (2) the electrode lead, and (3) the lead-to-device connector. A failure in any of these components causes the direct loss of the capability to activate a muscle consistently, usually resulting in a decrement in the function provided by the neuroprosthesis. Our results indicate that the electrode, lead, and connector system are extremely durable. We analyzed 238 electrodes that have been implanted as part of an upper-limb neuroprosthesis. Each electrode had been implanted at least 3 years, with a maximum implantation time of over 16 years. Only three electrode-lead failures and one electrode infection occurred, for a survival rate of almost 99 percent. Electrode threshold measurements indicate that the electrode response is stable over time, with no evidence of electrode migration or continual encapsulation in any of the electrodes studied. These results have an impact on the design of implantable neuroprosthetic systems. The electrode-lead component of these systems should no longer be considered a weak technological link.
Key words: electrodes, functional electrical stimulation, implants, neuroprosthesis, spinal cord injury, survival analysis.