I-Corps: Clinical Grade Microelectromechanical Neurostimulators

治疗重度听力损失、慢性疼痛、帕金森氏症和癫痫的公司必须依靠昂贵且技术有限的手工组装的神经刺激器电极阵列。由于低通量和成品率，这些设备价格昂贵；这种复杂性受到人手所能达到的程度的限制；而且在存在人为错误的情况下，质量保证很难维持。通过使用基于光刻技术的阵列自动化制造技术，该项目有可能显著降低成本，同时提高其可重复性和性能。微机电阵列有潜力使医疗设备制造商能够将其引线上的电极数量增加5倍，将电极的尺寸减小30倍以上，将引线的总体尺寸减小92%，并且易于定义阵列的机械性能。通过利用这项技术最终增加位置传感和驱动，该团队相信阵列的插入可以在很大程度上自动化，减少手术放置时间和成本，同时实现更好的放置和提高性能。在美国，神经系统疾病和失调的发病率正在上升。听力损失、帕金森氏病和癫痫等疾病现在比以往任何时候都更为普遍，而药物解决方案既缺乏有效性，又缺乏安全性。神经刺激植入物已经被开发用于治疗这种疾病，然而，由于手工组装制造，它们的性能和成本都很缺乏。在听力损失的情况下，迄今为止，全世界已经植入了超过150,000个人工耳蜗；然而，据估计，全世界有超过2.5亿人因听力损失而残疾。其中许多人生活在发展中国家，由于系统本身的费用和相关手术的费用，他们缺乏必要的资金来利用现有的假肢。通过使用基于光刻技术的神经刺激阵列，该团队有可能显著降低成本，同时提高手术安全性和性能。这项技术还将促进创造新的神经刺激装置（例如，用于失明和瘫痪），其尺寸和复杂性目前无法通过手工组装实现。提出的这项技术有望在全球范围内对神经紊乱和疾病的实际治疗方面取得重大飞跃，因此具有重大影响的潜力。

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.