Deep Brain Microelectrode Array for Functional Neurosurgery

描述（由申请人提供）：脑深部电刺激（DBS）设备-“脑起搏器”-最近已成为治疗严重运动障碍（如帕金森病和原发性震颤）的令人兴奋的新型神经技术。脑深部区域的精确映射对于在对患者风险最小的情况下获得DBS的最佳治疗是必要的。目前，电生理标测包括以小步缓慢推进单通道微电极，以记录电极尖端区域的神经活动。由于该过程的连续性，该过程是乏味且耗时的。该提案的主题是脑深部微电极阵列（DBMA），它是一种创新设备，沿其长度沿着具有多个精确放置的部位，允许在大脑的不同深度同时记录和刺激，从而实现更准确和更快的映射。DBMA是一种模块化设备，由最多18个记录位点组成，以双线性排列定位，以便可以同时监测跨越9 mm或更大的多个大脑区域。DBMA的基本组成部分是电极阵列和载体。电极阵列是一种基于聚酰亚胺的微加工器件，具有薄膜金属互连和电极位点。载体由临床级钨微电极和聚酰亚胺管组成。该器械采用FDA批准的材料设计，具有与单通道标测微电极相同的外形，基本上使其成为当前器械的替代品。第II阶段的具体目标1将侧重于通过在器械中添加适合宏刺激的环形部位来扩展第I阶段开发的记录阵列的功能。将针对大批量和临床器械生产优化制造技术。Specific Aim 2将开发一种临床级多通道数据采集和刺激系统，用于多模式DBMA。将确认在目标1和2中开发和台架测试的器械和仪器用于特定目标3中的动物标测手术。该项目的成果将是一个完整的深度脑映射系统（即，标测电极和仪器）准备进行临床前评价。该系统的动物研究版本将准备商业化。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使系统定位成为神经系统疾病立体定向干预的规划和实施的关键组成部分，这将进一步优化当前的治疗方法并促进新的治疗方法。脑深部电刺激（DBS）设备-“脑起搏器”-最近已经成为一种令人兴奋的新型神经技术，用于治疗严重的运动障碍，如帕金森病和原发性震颤。脑深部区域的精确定位对于获得DBS的最佳治疗以及对患者的最小风险是必要的。该项目将开发必要的工具，创新的脑深部映射电极和相关仪器，以提高映射过程的速度和准确性。

DESCRIPTION (provided by applicant): 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. 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 targeting of deep brain regions is necessary to obtain an optimal treatment of DBS with minimal risk to the patient. This project will develop the necessary tools, an innovative deep brain mapping electrode and associated instrumentation, to increase the speed and accuracy of the mapping procedure.