Deep Brain Microelectrode Array for Functional Neurosurgery

脑深部电刺激（DBS）装置--“脑起搏器”--最近已经成为一种令人兴奋的新产品 神经技术用于治疗严重的运动障碍，如帕金森病和原发性震颤。 脑深部区域的精确映射对于以最小风险获得DBS的最佳治疗是必要的 给病人。目前，电生理标测包括缓慢推进单通道 以小的步长移动微电极，以便记录电极尖端区域中的神经活动。这 由于该过程的连续性，该过程是乏味和耗时的。本提案的主题， 脑深部微电极阵列（DBMA）是一种具有多个精确放置部位的创新设备 沿着它的长度，允许在大脑的不同深度同时记录和刺激，导致 更准确和更快的映射。 DBMA是一种模块化设备，由多达18个记录位点组成，位于双线性 这样的布置使得可以同时监测跨越9mm或更大的多个大脑区域。的 DBMA的基本组件是电极阵列和载体。电极阵列是一个 基于聚酰亚胺的具有薄膜金属互连和电极位点的微制造装置。所述载体是 包括临床级钨微电极和聚酰亚胺管。这个装置的设计 使用FDA批准的材料并具有与单通道标测微电极相同的形状因子， 基本上使其成为当前设备的直接替代品。 第二阶段的具体目标1将侧重于扩展开发的记录阵列的功能， 第一阶段，在器械上添加适合宏刺激的环形部位。制造 技术将针对大批量和临床器械生产进行优化。第2章将开发一个 临床级多通道数据采集和刺激系统，用于多模式DBMA。的 在目标1和2中开发和台架测试的设备和仪器将被确认用于标测 在动物中的程序在具体目标3中。该项目的成果将是一个完整的深层大脑地图 系统（即，标测电极和仪器）准备进行临床前评价。一项动物研究 该系统的版本将准备用于商业化。 NeuroNexus，Inc.正在与FHC公司合作领导该项目，密歇根大学和 克利夫兰诊所的顾问这种多学科的努力将导致一个系统定位成为 神经系统疾病立体定向介入治疗计划和实施的关键组成部分， 能够进一步优化当前的治疗并促进新的治疗。

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.