Improved Electrode Material for High-Density Closed-Loop DBS.

用于高密度闭环 DBS 的改进电极材料。

• 批准号: 9410389
• 负责人: Artin Petrossians
• 金额: $ 72.58万
• 依托单位: PLATINUM GROUP COATINGS, LLC
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-15 至 2019-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9410389
• 关键词: Address; Adverse effects; Affect; Alloys; Animals; Area; Asthma; Autopsy; BRAIN initiative; Bilateral; Blindness; Brain; Brain region; Cell Death; Cells; Charge; Chronic; Chronic Disease; Clinical; Clinical Trials; Collaborations; Deep Brain Stimulation; Dementia; Deposition; Devices; Dystonia; Effectiveness; Electric Stimulation; Electrochemistry; Electrodes; Electronics; Epilepsy; Essential Tremor; FDA approved; Failure; Feedback; Film; Future; Generations; Glial Fibrillary Acidic Protein; Government Agencies; Heterogeneity; Histology; Hypertension; Implant; In Vitro; Industry; Inflammatory; Injection of therapeutic agent; Intercellular Fluid; Iridium; Label; Longevity; Macaca mulatta; Measures; Medical Device; Medicine; Mental Depression; Metals; Microelectrodes; Migraine; Minnesota; Modality; Modeling; Modernization; Morphology; Motor; Neuroglia; Neuronal Injury; Outcome; Output; Parkinson Disease; Patient-Focused Outcomes; Performance; Periodicity; Phase; Physiologic pulse; Platinum; Population; Process; Property; Regimen; Research; Safety; Site; Spectrum Analysis; Stimulus; Structure; Surface; System; Technology; Testing; Thalamic structure; Thick; Thinness; Time; Tissues; Tremor; United States; Universities; chronic pain; cost effective; deep brain stimulation array; deep brain stimulator; density; design; electric impedance; experimental study; flexibility; flexible electronics; immunohistochemical markers; implant design; implantable device; improved; in vivo; iridium oxide; manufacturing process; neuroregulation; neurotransmission; next generation; nonhuman primate; novel; preclinical study; programs; relating to nervous system; response; sensory feedback; submicron; surface coating; treatment response

Abstract. In the United States, over 100,000 deep brain stimulation (DBS) devices have been implanted to date for treatment of basic tremor, Parkinson’s disease and dystonia, and clinical trials are underway to evaluate indications for chronic pain, severe depression, migraines and dementia. DBS devices belong to a class of devices called implantable electrical stimulators, and close to 1 Million of these devices are implanted annually. While effective in many cases, DBS shows limited effectiveness in others and also has side effects. Preclinical studies predict that DBS arrays comprised of many densely packed, small electrodes can more precisely target specific regions of the brain to improve therapy. Further, incorporating some electrodes which can provide sensory feedback (closed loop) may be able to improve therapy efficiency and effectiveness. These discoveries are motivating the neuromodulation industry to develop smaller, less invasive electrodes. However, current electrode materials do not support small sizes without severely restricting the stimulus output. Hence, an improved electrode material will benefit present and future DBS systems. Platinum Group Coatings LLC has developed a cost-effective and materials-efficient process for applying an ultra-low impedance platinum-iridium alloy coating onto the contacts of DBS stimulator and cortical recording electrodes. This program, in collaboration with University of Minnesota, seeks to validate the performance advantages of this coating when applied to a novel, flex circuit electrode array for DBS. Specifically, PtIr-coated thin film electrodes will be tested in bi-directional (i.e. stimulation and sensing) modalities to assess efficacy as well as material safety and stability in a non-human primate model of Parkinson’s disease. This phase-II research will seek to determine the durability and longevity of Pt-Ir coating on thin-film high-density DBS electrodes used bi-directionally to assess the long-term recording and stimulation performance of the coatings in vivo.

抽象。 在美国，迄今为止已经植入了超过100，000个深部脑刺激（DBS）装置， 治疗基本震颤，帕金森病和肌张力障碍，临床试验正在进行中，以评估 慢性疼痛、严重抑郁症、偏头痛和痴呆症的适应症。DBS器械属于一类 植入式电刺激器，每年有近100万个这样的设备被植入。 虽然在许多情况下有效，但DBS在其他情况下显示出有限的有效性，并且也有副作用。临床前 研究预测，由许多密集排列的小电极组成的DBS阵列可以更精确地定位 大脑的特定区域来改善治疗。此外，结合一些电极，其可以提供 感觉反馈（闭环）能够提高治疗效率和有效性。这些发现 促使神经调节行业开发更小、侵入性更小的电极。但目前的 电极材料不支持小尺寸而不严重限制刺激输出。所以安 改进的电极材料将有益于目前和未来的DBS系统。 铂金集团涂料有限责任公司开发了一种具有成本效益和材料效率的工艺， DBS刺激器和皮质记录触点上的超低阻抗铂铱合金涂层 个电极该计划与明尼苏达大学合作，旨在验证性能 这种涂层在应用于DBS的新型柔性电路电极阵列时的优点。具体而言，PtIr涂层 薄膜电极将在双向（即刺激和感知）模式下进行测试，以评估有效性， 以及在帕金森病的非人灵长类动物模型中的材料安全性和稳定性。第二阶段的研究 将寻求确定所用薄膜高密度DBS电极上Pt-Ir涂层的耐久性和寿命 以评估涂层在体内的长期记录和刺激性能。