Archives of Facial Plastic Surgery · 2012 · 15 citations · 25 references
EngineeringBioengineeringSurgeryBiocompatibilityNeural EngineeringTissue EngineeringImplantable BiomaterialsImplantable Biomedical DevicesImplantable Neural DevicesNeural ProstheticsNeurostimulationProsthetic DevicesBiomedical ImplantsFibrous EncapsulationHistologic ExaminationImplant - Tissue InterfaceImplant-host InterfaceImplantable Neural StimulationPermanent Facial ParalysisPolymer-based Artificial Muscles
BACKGROUND: Current management of permanent facial paralysis centers on nerve grafting and muscle transfer; however, limitations of those procedures call for other options. OBJECTIVES: To determine the durability and biocompatibility of implanted artificial muscle in a gerbil model and the degree of inflammation and fibrosis at the host tissue-artificial muscle interface. METHODS: Electroactive polymer artificial muscle (EPAM) devices engineered in medical-grade silicone were implanted subcutaneously in 13 gerbils. The implanted units were stimulated with 1 kV at 1 Hz, 24 h/d via a function generator. Electrical signal input/output was recorded up to 40 days after implantation. The animals were euthanized between 23 and 65 days after implantation, and the host tissue-implant interface was evaluated histologically. RESULTS: The animals tolerated implantation of the EPAM devices well, with no perioperative deaths. The muscle devices created motion for a mean of 30.3 days (range, 19-40 days), with a mean of 2.6 × 106 cycles (range, 1.6 × 106 to 3.5 × 106 cycles). Histologic examination of the explanted devices revealed the development of a minimal fibrous capsule surrounding the implants, with no evidence of bacterial infection or inflammatory infiltrate. No evidence of device compromise, corrosion, or silicone breakdown was noted. CONCLUSIONS: Artificial muscle implanted in this short-term animal model was safe and functional in this preliminary study. We believe that EPAM devices will be a safe and viable option for restoration of facial motions in patients with irreversible facial paralysis.
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