Development of a novel larynx pacemaker multichannel array electrode: In vivo animal analysis.

OBJECTIVES/HYPOTHESIS Electrical stimulation of posterior cricoarytenoid muscle offers a physiological approach to retain the function of the paralyzed larynx muscle after paralysis. The aim of this study was to develop and evaluate a durable, biocompatible, and atraumatic array electrode for inclusion in a larynx pacemaker. In addition to developing the electrode array, an evaluation methodology using in vivo multichannel electromyography was assessed. STUDY DESIGN In vivo test procedures for material evaluation: an animal model. METHODS Over the research period, 42 array electrodes representing nine different prototypes were implanted in the triceps brachii muscle of 21 rats. Biocompatibility and atraumatic functions were evaluated via observation. Electrode function and durability were determined by comparison of daily electromyographic measurements of the muscle activity of the front leg (triceps brachii muscle) during locomotion. RESULTS The used animal model demonstrated electrode material problems that could not be material evaluation from in vitro tests alone. Through use of this in vivo method, it was found that an array tip that is durable, biocompatible, and atraumatic should consist of many small electrode plates cast in flexible silicone. The connecting wires to the individual electrode plates should be Litz wire, which consists of multiple strands. CONCLUSIONS The here demonstrated in vivo test method was a suitable animal model for designing and evaluating electrodes to be further developed for inclusion in human implants. LEVEL OF EVIDENCE N/A.