Fabrication and Characterization of a Flexible Thin-Film-Based Array of Microelectrodes for Corneal Electrical Stimulation

The electric stimulation (ES) of the cornea is a novel therapeutic approach to the treatment of degenerative visual diseases. Currently, ES is delivered by placing a mono-element electrode on the surface of the cornea that uniformly stimulates the eye along the electrode site. It has been reported that a certain degree of correlation exists between the location of the stimulated retinal area and the position of the electrode. Therefore, in this study, we present the development of a sectioned surface electrode for selective electric stimulation of the human cornea. The proposed device consists of 16 independent microelectrodes, a reference electrode, and 18 contact pads. The microelectrodes have a size of 200 µm × 200 µm, are arranged in a 4 × 4 matrix, and cover a total stimulation area of 16 mm(2). The proposed fabrication process, based on surface micromachining technology and flexible electronics, uses only three materials: polyimide, aluminum, and titanium, which allow us to obtain a simplified, ergonomic, and reproducible fabrication process. The fabricated prototype was validated to laboratory level by electrical and electrochemical tests, showing a relatively high electrical conductivity and average impedance from 712 kΩ to 1.4 MΩ at the clinically relevant frequency range (from 11 Hz to 30 Hz). Additionally, the biocompatibility of the electrode prototype was demonstrated by performing in vivo tests and by analyzing the polyimide films using Fourier transform infrared spectroscopy (FTIR). The resulting electrode prototype is robust, mechanically flexible, and biocompatible, with a high potential to be used for selective ES of the cornea.