ADVANCED MICROFABRICATION TECHNOLOGY

DESCRIPTION (provided by applicant): The broad, long-term objective of this program is to develop the tools, protocols and facilities needed to produce multielectrode arrays (MEAs) out of known biocompatible materials for eventual use in humans. This will require construction and commissioning of a computer-aided design (CAD), good manufacturing practice (GMP) facility and framework capable of fabricating a 2-dimensional MEA using an ultrashort (sometimes referred to as ultrafast) laser-based micromachining process. The direct-write technology developed herein will enable fabrication of an MEA out of flat platinum sheet material without the handling steps that compromise material plasticity in current designs. This array will then be laminated between two encapsulating layers of biocompatible polymer that serve to electrically isolate each electrode while providing flexible, mechanical support. We will use this technology to fabricate a robust, high quality, reliable cochlear implant (CI) electrode array functionally similar to those in clinical use today. We anticipate this new process technology will eliminate defects introduced during the current, hand-assembly process that results in failure and subsequent loss of residual hearing, compromised functionality, and higher cost. This effort will be performed in collaboration with a third party who wishes to evaluate this new technology as a possible replacement for their current method of manufacture. We anticipate that this program will improve health and functionality for the deaf community, especially for children during their formative years, in support of NIH's mission to improve health by mitigating disability. PUBLIC HEALTH RELEVANCE: The goal of this program is to develop the flexible, computer-assisted, integrated manufacturing cell required to fabricate neural prostheses of arbitrary shape and structure using ultrashort pulses of light. Commercial utility will be demonstrated by producing a novel, robust cochlear implant electrode array in collaboration with a well-known commercial manufacturer of cochlear implants. In furtherance of NIH's mission to reduce the burdens of illness and disability, we anticipate this program will result in a substantial improvement in quality, performance and size of this particular device and lay the foundation for production of a broad spectrum of medical device components serving other medical needs.