Development and Commercialization of Next Generation of Neural Microelectrode Arr

描述(申请人提供)：Normann等人开发的阵列技术。二十年前在犹他大学，目前正由BlackRock MicroSystems(前身为CyberDynamic，Inc.，CKI)制造并向神经科学研究社区销售。犹他州电极阵列(UEA)是唯一获得FDA和CE批准的高电极密度、穿透性微电极阵列，可供人类使用。这些阵列，无论是慢性的还是急性的，已经被证明在动物实验中非常有效，它们的商业可用性引起了相当大的兴趣。目前用于制造UEA的“制造”程序与20年前实验室最初开发时使用的程序密切相关。到目前为止，UEA的制造一直是在单个阵列的基础上进行的，因此制造技术不仅耗时而且劳动密集型。此外，现有的制造成本，包括水电费、人力和维护费用都很高。更重要的是，用于制造UEA的当前工艺对电极阵列几何形状和电特性的公差造成了限制。此外，UEA的扁平结构和目标组织的卷曲几何形状可能导致两个“交配”表面之间的耦合较差，导致活跃的电极尖端不靠近目标神经元组织。因此，对于高效的神经接口以及在实验和临床应用中的广泛实验应用，现有的UEA制造技术提供了不足的质量、可重复性和产量。需要开发成本更低但精度更高的批量制造技术。2006年，犹他大学提出并开始了优化现有工艺、探索新材料、设计符合宿主组织的电极阵列新架构以及为UEA制造开发晶片规模的工艺流程的工作。本申请的申请者由这样一个工程师团队组成，这些工程师是科学家，他们多年来一直在为UEA的技术开发工作。这项应用的目标是将犹他大学开发的制造技术转移到BlackRock MicroSystems，通过使现有的微电极阵列负担得起、更好、可靠，并可针对急性和慢性应用进行定制，使该技术成为可传播给神经科学和临床研究社区的交钥匙技术。 与公共卫生相关：这项新技术将使我们能够制造具有以下特征的神经多电极阵列：(A)形状均匀的微电极(B)小且均匀暴露的活性针尖部位(C)涂覆能够提供高电荷密度的电极材料，即高电荷注入能力(CIC)(D)沉积有用于慢性应用的高度坚固的封装材料，以及(E)卷曲的电极阵列以更好地与目标组织进行几何匹配。此外，该技术将以更低的制造成本和更快的交货期提供更好的质量、重复性和更高的电极阵列产量。所有这些优势将有助于使电极阵列对神经科学界来说负担得起和可评估。

DESCRIPTION (provided by applicant): The array technology developed by Normann et.al. two decades ago at the University of Utah is currently being manufactured and marketed to the neuroscience research community by Blackrock Microsystems (formerly known as Cyberkinetics, Inc., CKI). The Utah electrode array (UEA) is the only high- electrode density, penetrating microelectrode array that is FDA and CE approved, for human use. These arrays, both chronic and acute, have been shown to work very well in animal subjects and their commercial availability has met with considerable interest. The 'manufacturing' procedures that are used to fabricate the UEA at present are closely based on those that were used in their initial development in the laboratory, two decades ago. To date the fabrication of the UEA's has been carried out on a single array basis and as a result the manufacturing technique is not only time consuming but also labor intensive. Also, the existing fabrication costs including utilities, manpower, and maintenance are high. More importantly, the current processes used to fabricate the UEAs impose limitations in the tolerances of the electrode array geometry and electrical characteristics. Furthermore, the flat architecture of the UEA and convoluted geometry of the targeted tissue can result in poor coupling between the two "mating" surfaces, leading to active electrode tips that are not in proximity to the target neuronal tissue. Thus for an efficient neural interface and for wide experimental usage both in experimental and clinical applications, the existing UEA fabrication technique provides inadequate quality, repeatability, and throughput. There is a need to develop less costly but higher precision batch fabrication technology. In 2006, the University of Utah proposed and began work on optimizing existing processes, exploring new materials, designing new architecture of electrode array that are compliant with the host-tissue, and last but not the least developing wafer-scale based process flow for the UEA fabrication. The applicants of this application compose of such a team of engineers, scientists that have been working together over the past years on the technology development for the UEA. The goals of this application is to transfer the manufacturing technology developed at the University of Utah to Blackrock Microsystems, making the technology into a turnkey technology that can be disseminated to the neuroscience and clinical research community, by making the existing microelectrode arrays affordable, better, reliable, and customizable for both acute and chronic applications. PUBLIC HEALTH RELEVANCE: Relevance The new technology would allow us to fabricate neural multielectrode arrays with (a) uniformly shaped microelectrodes (b) small and uniformly exposed active tip sites (c) coated with an electrode material that can deliver high charge densities i.e. high charge injection capacity (CIC) (d) deposited with a highly robust encapsulation material for chronic applications and (e) convoluted electrode arrays for better geometrical match with the targeted tissue. Furthermore the technology would provide better quality, repeatability, and higher throughput of electrode arrays at lower cost of manufacturing and faster lead time. All these advantages would help in making the electrode arrays affordable and assessable to the neuroscience community.