title: Durability of implanted electrodes and leads in an upper-limb neuroprosthesis.
abstract: 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.
authors.affiliation: Department of Orthopaedics, MetroHealth Medical Center Cleveland, OH 44109, USA. klk4@cwru.edu
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Kilgore
authors.forename: P Hunter
authors.initials: PH
authors.lastname: Peckham
authors.forename: Michael W
authors.initials: MW
authors.lastname: Keith
authors.forename: Fred W
authors.initials: FW
authors.lastname: Montague
authors.forename: Ronald L
authors.initials: RL
authors.lastname: Hart
authors.forename: Martha M
authors.initials: MM
authors.lastname: Gazdik
authors.forename: Anne M
authors.initials: AM
authors.lastname: Bryden
authors.forename: Scott A
authors.initials: SA
authors.lastname: Snyder
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Stage
mesh_terms: D000328:Adult; D015331:Cohort Studies; D004599:Electric Stimulation Therapy / Q000379:methods*; D004567:Electrodes, Implanted; D005260:Female; D018737:Hand Strength; D006801:Humans; D008297:Male; D008875:Middle Aged; D011336:Probability; D011379:Prognosis; D011474:Prosthesis Design; D011475:Prosthesis Failure; D011782:Quadriplegia / Q000534:rehabilitation*; D020127:Recovery of Function; D012189:Retrospective Studies; D018570:Risk Assessment; D013119:Spinal Cord Injuries / Q000175:diagnosis / Q000534:rehabilitation; D016896:Treatment Outcome; D034941:Upper Extremity / Q000294:innervation*