Deep Brain Microelectrode Array for Functional Neurosurgery

用于功能神经外科的深部脑微电极阵列

• 批准号: 7486243
• 负责人: Jamille F Hetke
• 金额: $ 63.42万
• 依托单位: NEURONEXUS TECHNOLOGIES
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-15 至 2011-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7486243
• 关键词: Animal Experimentation; Animals; Brain; Brain Mapping; Brain region; Clinic; Clinical; Collaborations; Deep Brain Stimulation; Depth; Devices; Drops; Electrodes; Essential Tremor; Film; Intervention; LDLR gene; Length; Maps; Metals; Michigan; Microelectrodes; Monitor; Movement Disorders; Nature; Outcome; Pacemakers; Parkinson Disease; Patients; Phase; Positioning Attribute; Procedures; Process; Production; Risk; Shapes; Site; Speed; System; Techniques; Testing; Time; Tube; Tungsten; United States Food and Drug Administration; Universities; base; commercialization; data acquisition; design; innovation; instrumentation; nervous system disorder; neurosurgery; neurotechnology; novel; pre-clinical; relating to nervous system; research clinical testing; tool

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.

描述（由申请人提供）：深部脑刺激（DBS）装置——“脑起搏器”——最近已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，例如帕金森病和特发性震颤。准确绘制深部大脑区域对于获得 DBS 的最佳治疗以及将患者风险降至最低是必要的。目前，电生理图绘制涉及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。由于该过程的串行性质，该过程是乏味且耗时的。该提案的主题是深部脑微电极阵列（DBMA），是一种创新设备，沿其长度有多个精确放置的位点，允许在大脑不同深度同时记录和刺激，从而实现更准确、更快速的绘图。 DBMA 是一种模块化设备，由多达 18 个以双线性排列的记录位点组成，因此可以同时监测跨越 9 毫米或更长的多个大脑区域。 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。该载体由临床级钨微电极和聚酰亚胺管组成。该设备采用 FDA 批准的材料设计，具有与单通道标测微电极相同的外形尺寸，本质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 将侧重于通过向设备添加适合宏观刺激的环形位点来扩展第一阶段开发的记录阵列的功能。制造技术将针对大批量临床设备生产进行优化。 Specific Aim 2 将开发临床级多通道数据采集和刺激系统，与多模式 DBMA 一起使用。目标 1 和 2 中开发和台架测试的设备和仪器将经过验证，可用于具体目标 3 中的动物测绘程序。该项目的成果将是一个完整的深部脑测绘​​系统（即测绘电极和仪器），可供临床前评估。该系统的动物研究版本将准备商业化。 NeuroNexus, Inc. 与 FHC, Inc.、密歇根大学以及克利夫兰诊所的顾问合作领导该项目。这种多学科的努力将产生一个系统，该系统将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，这将有助于进一步优化当前的治疗方法并促进新的治疗方法。深部脑刺激（DBS）设备——“脑起搏器”——最近作为一种令人兴奋的新型神经技术出现，用于治疗严重的运动障碍，如帕金森病和特发性震颤。准确定位大脑深部区域对于获得 DBS 的最佳治疗以及将患者风险降至最低是必要的。该项目将开发必要的工具、创新的深部脑测绘​​电极和相关仪器，以提高测绘过程的速度和准确性。