On Biocompatibility and Stability of Transversal Intrafascicular Multichannel Electrodes-TIME

Transversal intrafascicular multichannel electrodes (TIME) have been developed to interface with peripheral nerves after upper limb amputation. Intended use is the electrical stimulation of the median and ulnar nerve to deliver sensory feedback during phantom limb pain treatment and artificial hand control. Miniaturized electrode arrays were developed on polyimide substrates with thin film metallization using sputtered iridium oxide as electrode coating. Here, we report on the essential requirements including biocompatibility, mechanical and stimulation stability that have been investigated before permission was granted by the legal authorities to conduct subchronic first-in-man clinical trials. Explants have been investigated to identify possible first failure points and optimize the devices for chronic implantation.