Mechanical design and analysis of implantable components for a retinal prosthesis

Abstract

The success of a retinal prosthesis in restoring vision to blind patients will be dependent on its long term viability when implanted in the eye. This thesis addresses mechanical aspects relating to the biocompatibility of the device and its ability to survive in a saline environment. Chronic testing of a working prosthesis requires hermetic encapsulation of all implanted electronics; any direct contact with the fluid in the eye will damage the circuitry and render the device ineffectual. A metal housing, which has provided effective protection of other prostheses, would interfere with light transmission from the external source and is therefore impractical. Encapsulation of the electronics in transparent polymers is a potential alternative. Our current prosthesis design requires both a polyimide electrode array and a return wire to penetrate the protective capsule. Therefore, a technique for evaluating the hermetic encapsulation of these components was designed and tested. Simple, expendable models of the prosthesis were developed and used to test silicone as an encapsulant. In a 60 day soak test, all prosthesis models failed within three days, while completely encapsulated control models exhibited no current leakage. For the silicone application methods and implant materials currently being used, silicone is not an effective encapsulant. The majority of the implanted electronics, including a photodiode array, will be supported in the front of the eye by an intraocular support structure. Early designs of this structure were based on the structure of commercially available intraocular lenses commonly used in cataract surgeries. Using stereolithography, a rapid prototyping technique, this structure was redesigned based on mechanical and surgical criteria. The existing haptic system was modified to improve stability, and arrangement of the photodiode array on the structure was optimized. In addition, the structure itself was simplified for fabrication from biocompatible materials. Stability of the entire structure relative to the eye and of the photodiode array relative to the structure was analyzed using finite element methods. The final design, when injection molded from silicone rubber, was tested surgically by implantation into animal eyes. The surgery was successful, and the basic design will be used in future tests.