In vitro and in vivo evaluation of a photosensitive polyimide thin-film microelectrode array suitable for epiretinal stimulation

Abstract

BackgroundEpiretinal implants based on microelectro-mechanical system (MEMS) technology with a polyimide (PI) material are being proposed for application. Many kinds of non-photosensitive PIs have good biocompatibility and stability as typical MEMS materials for implantable electrodes. However, the effects of MEMS microfabrication, sterilization and implantation using a photosensitive polyimide (PSPI) microelectrode array for epiretinal electrical stimulation has not been extensively examined.MethodsA novel PSPI (Durimide 7510) microelectrode array for epiretinal electrical stimulation was designed, fabricated based on MEMS processing and microfabrication techniques. The biocompatibility of our new microelectrode was tested in vitro using an MTT assay and direct contact tests between the microelectrode surface and cells. Electrochemical impedance characteristics were tested based on a three-electrode testing method. The reliability and stability was evaluated by a chronic implantation of a non-functional array within the rabbit eye. Histological examination and SEM were performed to monitor possible damage of the retina and microelectrodes. Electrically evoked potentials (EEPs) were recorded during the acute stimulation of the retina.ResultsThe substrate was made of PSPI and the electrode material was platinum (Pt). The PSPI microelectrode array showed good biocompatibility and appropriate impedance characteristics for epiretinal stimulation. After a 6-month epiretinal implantation in the eyes of rabbits, we found no local retinal toxicity and no mechanical compression caused by the array. The Pt electrodes adhesion to the PSPI remained stable. A response to electrical stimuli was with recording electrodes lying on the visual cortex.ConclusionWe provide a relevant design and fundamental characteristics of a PSPI microelectrode array. Strong evidences on testing indicate that implantation is safe in terms of mechanical pressure and biocompatibility of PSPI microelectrode arrays on the retina. The dual-layer process we used proffers considerable advantages over the more traditional single-layer approach and can accommodate much many electrode sites. This lays the groundwork for a future, high-resolution retinal prosthesis with many more electrode sites based on the flexible PSPI thin film substrate.

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Bioinspired Prosthetic Interfaces

“…The retinal implant was able to work without any electrode degradation and tissue response over six months in two canines with an impedance value of ≈5 kΩ at 1 kHz with a charge density of ≈0.34 mC cm −2 . Recently, Jiang et al used a flexible photosensitive polyimide (PSPI) with Pt electrodes for the simpler UV photopatternability of microelectrode array that showed good biocompatibility with increased impedance and charge density values (≈14 kΩ at 1 kHz and ≈2.8 mC cm −2 ) over six months in rabbits …”

Blending Electronics with the Human Body: A Pathway toward a Cybernetic Future

“…PI's can accomplish this daring task, since they are biocompatible and moldable into the ultrathin and delicate electronic devices required of retinal prosthetics. They also recover to their original shape even after rolling or folding in stark contrast to silicone‐based electronics 420, 421. Furthermore, other type of polymers such as parylene C and PET have been proposed for retinal prosthetic, however, they have higher CTE and lower T g compared to PI, as described in Section 2.2 (PI) and Section 2.3 (PET and parylene C) 422, 423.…”