Deep Brain Microelectrode Array for Functional Neurosurgery

描述(申请人提供)：深部脑刺激(DBS)设备-脑起搏器-最近作为一种令人兴奋的新神经技术出现，用于治疗严重的运动障碍，如帕金森氏病和原发性震颤。准确的脑深部区域标测对于获得最佳的DBS治疗是必要的，同时将患者的风险降至最低。目前，电生理标测包括以小步的方式缓慢推进单通道微电极，以记录电极尖端区域的神经活动。由于程序的连贯性，这一过程既繁琐又耗时。这项提议的主题是深部脑微电极阵列(DBMA)，这是一种创新的设备，它沿其长度方向有多个精确放置的位置，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，它由多达18个记录点组成，以双线性方式布置，以便可以同时监测跨越9毫米或更多的多个大脑区域。DBMA的基本部件是电极阵列和载体。电极阵列是一种基于聚酰亚胺的微细加工器件，具有薄膜金属互连和电极位置。该载体由临床级钨微电极和聚酰亚胺管组成。该设备是使用FDA批准的材料设计的，具有与单通道映射微电极相同的外形系数，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将侧重于通过向设备添加适合于宏观刺激的环形部位来扩展在第一阶段开发的记录阵列的功能。制造技术将进行优化，以适应大批量和临床设备的生产。具体目标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。在AIMS 1和AIMS 2中开发和台架测试的设备和仪器将被验证用于特定AIMS 3中的动物测绘程序。该项目的结果将是一个完整的大脑深部测绘系统(即测绘电极和仪器)，准备进行临床前评估。该系统的动物研究版本将准备好商业化。NeuroNexus公司正在与FHC公司、密歇根大学和克利夫兰诊所的顾问合作领导该项目。这一多学科的努力将使该系统成为规划和提供神经疾病立体定向干预的关键组成部分，这将使目前的治疗进一步优化，并促进新的治疗。深部脑刺激(DBS)设备--脑起搏器--最近作为一种令人兴奋的新神经技术出现，用于治疗严重的运动障碍，如帕金森氏病和原发性震颤。为了获得对患者风险最小的DBS的最佳治疗，有必要对大脑深部区域进行准确的靶向治疗。该项目将开发必要的工具，创新的大脑深部标测电极和相关仪器，以提高标测程序的速度和准确性。

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.