The BION devices: injectable interfaces with peripheral nerves and muscles.

Abstract

OBJECT: The purpose of this study was to describe a novel technology for implantable neuromuscular stimulation to treat complications of paralysis and disuse atrophy, including shoulder subluxation, hand contractures, drop foot, and osteoarthritis. The authors review the results so far of several pilot clinical studies of these muscle stimulation devices. METHODS: Miniature wireless stimulators received power and individually addressed command signals from an external radiofrequency transmission coil. One or more implants were injected through a 12-gauge hypodermic insertion tool into muscles or adjacent to motor nerves, where they provided the means to activate the muscles in any desired pattern of intensity and frequency. Randomized controlled studies in small numbers of patients are underway to identify efficacy, acceptability, best methods of practice, and any design changes that may be required to improve the technology. Fifty patients have been enrolled in five studies; 35 patients have undergone implantation of a total of 79 BION1 devices. Comparisons with surface stimulation in patients who have suffered a stroke with shoulder subluxation and hand contractures show similar improvements in objective measures of efficacy but higher comfort levels for stimulation by implants. CONCLUSIONS: Injected microstimulators represent a promising new class of technology for the rehabilitation of patients with upper motor neuropathies. As the technology evolves, practitioners may be able to use it to facilitate functional reanimation of paralyzed limbs.