Deep Brain Microelectrode Array for Functional Neurosurgery

深度脑刺激(DBS)设备--脑起搏器--最近以一种令人兴奋的小说形式出现 治疗严重运动障碍的神经技术，如帕金森氏症和特发性震颤。 为了以最小的风险获得DBS的最佳治疗，有必要对大脑深部区域进行准确的标测 给病人的。目前，电生理标测涉及缓慢推进单通道 小步微电极，以记录电极尖端区域的神经活动。这 由于程序的连贯性，这一过程冗长而耗时。这项提案的主题是， 深脑微电极阵列(DBMA)，是一种具有多个精确放置位置的创新设备 它允许在大脑的不同深度同时记录和刺激，导致 更准确、更快速的映射。 DBMA是一种模块化设备，由最多18个记录站点组成，以双线形式放置 可以同时监测跨越9毫米或更大的多个脑区的安排。这个 DBMA的基本部件是电极阵列和载体。电极阵列是一种 具有薄膜金属互连和电极位置的聚酰亚胺微细加工器件。承运人是 由临床级钨微电极和聚酰亚胺管组成。这个装置已经设计好了 使用FDA清除的材料并具有与单通道标测微电极相同的形状系数， 基本上使其成为当前设备的临时替代品。 第二阶段的具体目标1将侧重于扩展#年开发的记录阵列的功能 通过在装置中添加适合于宏观刺激的环形部位来进行第一阶段。制造业 技术将进行优化，以实现大批量和临床设备的生产。特定目标2将开发一种 与多模式DBMA配合使用的临床级多通道数据采集和刺激系统。这个 将验证AIMS 1和AIMS 2中开发的设备和仪器，并进行平台测试，以便在测绘中使用 在动物身上进行特定目标的程序3.该项目的结果将是一个完整的脑深部图 系统(即标测电极和仪器)已准备好进行临床前评估。一项动物研究 该系统的版本将准备好商业化。 NeuroNexus，Inc.与FHC，Inc.、密歇根大学和 克利夫兰诊所的顾问。这一多学科的努力将导致一个定位为 计划和实施立体定向干预治疗神经疾病的关键组成部分，这将 使现有治疗进一步优化，并促进新的治疗。

Deep brain stimulation (DBS) devices - `brain pacemakers' - have recently emerged as an exciting novel neurotechnology for treating severe movement disorders, such as Parkinson's Disease and Essential Tremor. Accurate mapping of deep brain regions is necessary to obtain an optimal treatment of DBS with minimal risk to the patient. At present, electrophysiological mapping involves slowly advancing a single-channel microelectrode in small steps in order to record the neural activity in the region of the electrode tip. This process is tedious and time-consuming due to the serial nature of the procedure. The subject of this proposal, the Deep Brain Microelectrode Array (DBMA), is an innovative device that has multiple precisely placed sites along its length which permit simultaneous recording and stimulation at different depths in the brain, leading to more accurate and faster mapping. The DBMA is a modular device that consists of up to 18 recording sites positioned in a bi-linear arrangement such that multiple brain regions spanning 9mm or more may be monitored simultaneously. The basic components of the DBMA are the electrode array and the carrier. The electrode array is a microfabricated device based on polyimide with thin-film metal interconnects and electrode sites. The carrier is comprised of a clinical grade tungsten microelectrode and a polyimide tube. The device has been designed using FDA cleared materials and has the same form factor as a single-channel mapping microelectrode, essentially making it a drop-in replacement for the current device. Specific Aim 1 of Phase II will focus on extending the functionality of the recording array developed in Phase I by adding ring-shaped sites to the device that are suitable for macrostimulation. Manufacturing techniques will be optimized for high volume and clinical device production. Specific Aim 2 will develop a clinical grade multichannel data acquisition and stimulation system for use with the multimodal DBMA. The devices and instrumentation developed and bench tested in Aims 1 and 2 will be validated for use in mapping procedures in animals in Specific Aim 3. The outcome of the project will be a complete deep brain mapping system (i.e., mapping electrodes and instrumentation) ready for pre-clinical evaluation. An animal research version of the system will be ready for commercialization. NeuroNexus, Inc. is leading the project in collaboration with FHC, Inc., the University of Michigan and consultants from the Cleveland Clinic. This multi-disciplinary effort will result in a system positioned to become a key component in the planning and delivery of stereotactic interventions for neurological disorders, which will enable further optimization of current treatments and facilitate new treatments.