I-Corps: Clinical Grade Microelectromechanical Neurostimulators

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Companies dealing with profound hearing loss, chronic pain, Parkinson's disease, and epilepsy must rely on expensive and technologically-limited hand-assembled electrode arrays in their neurostimulators. These devices are costly due to low throughput and yield; the complexity is limited by what can be achieved with the human hand; and quality assurance is difficult to maintain in the presence of human error. By using lithographically-based technology for the automated manufacturing of arrays, this project has the potential to significantly reduce their cost while improving their reproducibility and performance. The microelectromechanical arrays has the potential to enable medical device manufacturers to increase the number of electrodes on their leads by 5X, reduce the size of the electrodes by greater than 30X, reduce the overall size of the leads by 92%, and easily define the mechanical properties of the arrays. And by utilizing this technology to eventually add position sensing and actuation, the team believes that the insertion of the arrays can be largely automated, reducing surgical placement time and cost while allowing better placement and improved performance.There is a rise in the incidence of neurological diseases and disorders in the US. Conditions such as hearing loss, Parkinson's disease, and epilepsy are more prevalent now than ever, and pharmaceutical solutions are lacking in both effectiveness and safety. Neurostimulation implants have been developed to treat such conditions, however, their performance and costs are lacking, due to hand-assembly manufacturing. In the case of hearing loss, over 150,000 cochlear prosthetics have been implanted worldwide to date; however, over 250 million people worldwide are estimated to be disabled due to hearing loss. Many of these people are in developing countries and lack the funds necessary to take advantage of current prostheses, both due to the cost of the systems themselves and due to the cost of the associated surgery. By using lithographically-based technology for the neurostimulation arrays, the team has the potential to significantly reduce their cost while improving their surgical safety and performance. The enabling technology will also promote the creation of new neurostimulation devices (e.g., for blindness and paralysis) whose size and complexity is not currently achievable with hand-assembly. The technology being proposed promised to result in a significant leap forward in the practical treatment of neurological disorders and diseases on a worldwide scale and thus possesses the potential for significant impact.