Development of a large area high resolution micro ECoG electrode array

 描述(申请人提供)：这项工作旨在开发一种用于皮质电成像(ECoG)的微电极阵列，允许以高空间分辨率记录和刺激大面积大脑表面的神经活动。现有的技术要么允许以低空间分辨率(标准商业脑电地形图)在大脑区记录神经活动，要么(Ii)以高空间分辨率在小脑区(所谓的微脑电)记录神经活动。BMSEED的目标是生产大面积高分辨率的微ECoG电极阵列(Lahr？ECoGs)。传统的ECoG电极阵列被放置在大脑表面，并被用作穿透性微电极的一种侵入性较小的替代方案，后者被插入脑组织。它们被用来(I)在神经科学研究中探索大脑如何运作的基本原理，(Ii)在脑机接口(BMI)中记录神经活动，为截肢者驱动神经假体或为瘫痪者移动计算机光标，以及(Iii)在癫痫手术期间监测神经活动，以确定产生癫痫发作的核心区域，然后将其移除。这些应用将受益于BMSEED的LahrµECoG，因为它将在大范围内对记录的信号(即正常神经活动和癫痫)提供更准确的定位，从而改进大脑研究，使BMI更强大，并通过为神经外科医生提供更准确的癫痫活动定位来改善癫痫手术的临床结果。在所有ECOG中，每个记录电极需要一根导线来电连接到数据采集系统，而不与其他导线相交(即，不短路)。这变得越来越困难 随着电极密度和总数的增加。BMSEED的Lahr？ECoG通过在多层布线引线来解决这一问题。此外，我们的专利技术使用微制造技术生产机械坚固的微电极，使我们能够减少设备的厚度，从而降低设备的硬度，使植入物更具柔顺性。重要的是，BMSEED的LahrµECoG完全由适合植入人体的材料组成，从而简化了FDA的审批流程。第一个具体目标是优化不同级别之间的斜率轮廓，以提供可靠的电气连接，并制造LahrµECoG原型并对其进行机电特性表征。第二个目标是展示原型的生物兼容性和能力。为此，将在五只猫身上长期植入Lahr？ECoG，并将获得至少两个月的神经记录和微刺激数据。在第一阶段结束时，BMSEED将(I)开发出生产多层金属化和LahrµECoG原型的能力，并(Ii)在CAT模型中表征它们的能力。在第二阶段，BMSEED将把LahrµECoGs的开发扩展到更大的临床相关基板尺寸的多层金属化。我们的客户最初将是研究实验室，在FDA批准后，客户将是用于BMI应用的生物医学公司和用于临床应用的医院。

 DESCRIPTION (provided by applicant): This work is directed at the development of a microelectrode array for electrocorticography (ECoG) that allows the recording and stimulation of neural activity on the surface of the brain over a large area at high spatial resolution. Existig technologies either allow the recording of neural activity (i) over a large brain area at low spatil resolution (standard commercial ECoGs), or (ii) over a small brain area at high spatial resolution (so called µECoGs). BMSEED aims to produce large-area-high-resolution µECoG electrode arrays (lahrµECoGs). Conventional ECoG electrode arrays are placed on the surface of the brain, and are used as a less invasive alternative to penetrating microelectrodes, which are inserted into the brain tissue. They are used (i) in neuroscience research to explore the fundamentals of how the brain operates, (ii) in brain-machine-interfaces (BMIs) to record neural activity to drive a neuroprosthesis for amputees or to move a computer cursor for the paralyzed, and (iii) for monitoring neural activity during epilepsy surgery to identify the regions of the corex that generate seizures, which subsequently are removed. These applications would benefit from BMSEED's lahrµECoG because it would provide more accurate localization of the recorded signals (i.e., normal neural activity as well as seizures) over a large area, thus improving brain research, making BMIs more robust, and improving clinical outcomes in epilepsy surgery by providing the neurosurgeon with more accurate localization of seizure activity. In all ECOGs, each recording electrode requires one wire to electrically connect to the data acquisition system without intersecting (i.e., without shorting) with other wires. This becomes increasingly difficult as the density and total number of electrodes increases. BMSEED's lahrµECoG solves this problem by routing the lead wires on multiple levels. In addition, our proprietary technology to produce mechanically robust microelectrodes using microfabrication techniques allows us to reduce the thickness, thus the stiffness, of the device, making the implant more compliant. Importantly, BMSEED's lahrµECoG consists entirely of materials that are suitable for implantation in humans, thus simplifying the FDA approval process. The first specific aim is to optimize the profile of the slope between different levels to provide a reliable electrical connection, and to fabricate and electromechanically characterize prototypes of the lahrµECoG. The second aim is to demonstrate the biocompatibility and capabilities of the prototypes. To that end, a lahrµECoG will be chronically implanted in five cats, and neural recording and micro-stimulation data will be obtained for at least two months. At the end of phase I, BMSEED will have (i) developed the capability to produce multi-level metallization and prototypes of lahrµECoGs, and (ii) characterized their capabilities in a cat model. In phase II, BMSEED will extend the lahrµECoGs development to multi-level metallization on larger, clinically relevant substrate sizes. Our customers will initially be research laboratories, and, after FDA approval, biomedical companies for BMI applications and hospitals for clinical applications.