High-Density Hermetic Packaging for Next-Generation Neural Prostheses

描述（由申请人提供）： 项目摘要/摘要本提案的目的是开发新一代小型化植入式微刺激器，适合于患者眼睛中的慢性植入，以治疗视网膜退行性疾病。在这项研究中，我们将使用涂有无机材料的聚酰亚胺电极阵列结构，以提供持久的植入物-组织界面。还将开发假体的定制包装和组装方法。根据本提案要完成的任务包括聚酰亚胺多层电极阵列结构的微制造，用于与我们的微型神经刺激器设计相匹配。我们还将评价这些结构的生物相容性和生物稳定性，这将在CIVR中通过体外浸泡试验和尤卡坦小型猪动物模型中使用有源和无源器械的生存手术进行部分评价。我们将与供应商一起制造新一代的高密度陶瓷馈线，并将其纳入最先进的200通道密封钛封装中，用于我们的视网膜微刺激器，这将导致临床相关的视觉修复。拟议的努力和VA正在进行的患者护理使命之间的关系是，这些改进有望通过比以前更具体、更有针对性的神经刺激开辟新的康复可能性-特别是对于恢复盲人患者真正有用的视力，但也适用于其他医学领域，如深部脑或脊髓刺激。 总之，我们希望我们所服务的盲人群体最终将受益于我们创造复杂的、高度生物稳定的视网膜神经刺激器的能力所带来的视力改善;此外，预计未来所有类型的无线植入式假体的通道容量和功效都将得到改善。 公共卫生相关性： 随着退伍军人人口在未来几年中老龄化，由于例如年龄相关性黄斑变性（AMD）引起的视力丧失而导致的进行日常生活活动的能力的丧失将伴随着巨大的社会成本而发生。必须尽快采取行动，开发一种可行的视觉假体，可以恢复这些患者真正有用的视力; AMD是美国失明的主要原因。拟议的努力旨在开发使之成为可能的技术。根据退伍军人事务部自己的估计，到2011年，有严重视力障碍的退伍军人人数将达到43万人。目前还没有有效恢复大多数AMD患者丧失的视力的治疗方法，并且为不断增长的患者群体开发康复手段的紧迫性不能被夸大。

DESCRIPTION (provided by applicant): Project Summary/Abstract The aim of this proposal is to develop a new generation of miniaturized implantable micro-stimulators suitable for chronic implantation in a patient's eye to treat degenerative diseases of the retina. In this study, we will use polyimide electrode array structures coated with inorganic materials to provide a long-lasting implant-tissue interface. Custom packaging and assembly methods for the prostheses will also be developed. The tasks to be accomplished under this proposal include the microfabrication of multi-layered electrode array structures in polyimide for mating with our micro-neurostimulator designs. We will also evaluate the biocompatibility and biostability of these structures, which will be done in part at the CIVR through both in vitro soak-testing experiments and through survival surgeries in Yucatan mini- pig animal models with active and passive devices. Together with our vendors, we will fabricate new generations of high-density ceramic feedthroughs and incorporate these into state-of-the- art 200-channel hermetic titanium packages for our retinal microstimulators that will lead to clinically relevant visual prosthetics. The relationship between the proposed effort and the ongoing patient care mission of the VA is that these improvements are expected to open up new rehabilitative possibilities through more specific, targeted neural stimulation than has previously been possible- especially for the restoration of truly useful vision to blind patients, but also in other areas of medicine such as deep brain or spinal cord stimulation. In sum, it is our hope that the blind population we serve will ultimately benefit from the improved visual acuity that will arise from our ability to create complex, highly biostable retinal neurostimulators; additionally, the channel capacity and efficacy of future wireless implantable prostheses of all types is expected to be improved. PUBLIC HEALTH RELEVANCE: Project Narrative As the veteran population ages in the years to come, the loss of the ability to perform the activities of daily living resulting from vision loss due, for example, to age- related macular degeneration (AMD) will occur with great social costs. Action must be taken soon to develop a viable visual prosthesis that can restore truly useful vision to these patients; AMD is the leading cause of blindness in the US. The proposed effort is aimed at technology development that will make this possible. According to the VA's own estimates, the number of veterans with significant visual impairment will reach 430,000 by the year 2011. There exists no current treatment that effectively restores lost vision in the majority of AMD patients, and the urgency of developing rehabilitative means for the growing patient population cannot be overstated.