Abstract
ObjectiveUncertain biological consequences of titanium-magnet (Ti-mag) tongue implants constrain application of the Tongue Drive System (TDS), a brain-tongue-computer interface for individuals with severe physical impairment. Here we describe oromotor function and tongue tissue response following Ti-Mag implantation and explantation in the miniature pig, an animal model with a tongue similar in size to humans. DesignA 1.8×6.2mm Ti-mag tracer was implanted into the anterior tongue in five Yucatan minipigs. X-rays were taken immediately and >six days after implantation to evaluate tracer migration. In three minipigs, the tracer was explanted >16days after implantation. Twenty-five days post-explantation, tongue tissue was harvested and processed for histological and immunohistochemical (IHC) markers of healing. In two minipigs tissue markers of healing were evaluated post-mortem following >12days implantation. Drink cycle rate (DCR) was characterized to determine the impact of procedures on oromotor function. ResultsNeither implantation (N=5) nor explantation (N=3) changed DCR. X-rays revealed minimal tracer migration (N=4, 0–4mm). By histology and IHC a robust capsule was present two weeks post-implantation with limited fibrosis. Explantation produced localized fibrosis and limited muscle remodeling. ConclusionsThese findings suggest the safety of Ti-mag anterior tongue implants for assistive technologies in humans.
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