Bio-Compatibility and Bio-Insulation of Implantable Electrode Prosthesis Ameliorated by A-174 Silane Primed Parylene-C Deposited Embedment

Abstract

Microelectrodes for pain management, neural prosthesis or assistances have a huge medical demand, such as the application of pain management chip or retinal prosthesis addressed on age-related macular degeneration (AMD) and the retinitis pigmentosa (RP). Due to lifelong implanted in human body and direct adhesion of neural tissues, the electrodes and associated insulation materials should possess an ideal bio-compatibility, including non-cytotoxicity and no safety concern elicited by immune responses. Our goal intended to develop retinal prosthesis, an electrical circuit chip used for assisting neural electrons transmission on retina and ameliorating the retinal disability. Therefore, based on the ISO 10993 guidance for implantable medical devices, the electrode prosthesis with insulation material has to conduct bio-compatibility assessment including cytotoxicity, hemolysis, (skin) irritation and pathological implantation examinations. In this study, we manufactured inter-digitated electrode (IDE) chips mimic the electrode prosthesis through photolithography. The titanium and platinum composites were deposited onto a silicon wafer to prepare an electric circuit to mimic the electrode used in retinal prosthesis manufacture, which further be encapsulated to examine the bio-compatibility in compliance with ISO 10993 and ASTM guidance specifically for implantable medical devices. Parylene-C, polyimide and silicon carbide were selected as materials for electrode encapsulation in comparison. Our data revealed parylene-C coating showed a significant excellence on bio-insulation and bio-compatibility specifically addressed on implantable neuron stimulatory devices and provided an economic procedure to package the electrode prosthesis. Therefore, parylene C encapsulation should serve as a consideration for future application on retinal prosthesis manufacture and examination.