Improved Electrode Material for Deep Brain Stimulation

描述（由申请人提供）：在美国，迄今为止已植入超过100，000个脑深部电刺激（DBS）装置，用于治疗基础性震颤、帕金森病和肌张力障碍，并且正在进行临床试验，以评估慢性疼痛、严重抑郁症、偏头痛和痴呆症的适应症。DBS设备属于一类称为植入式电刺激器的设备，每年植入近100万台此类设备。这些设备使用与组织接触的电极向目标细胞传递电脉冲，以引起特定的治疗反应。随着电池磨损，必须更换器械，因此，器械效率的提高将延长器械使用寿命并减少更换手术的次数。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阵列可以精确地靶向脑干区域以改善治疗。一般来说，神经调节行业一直在朝着更小、侵入性更小的电极发展。因此，有强烈的临床、工程和电力动机转向更小的电极。然而，目前的电极材料不支持小尺寸而不严重限制刺激输出。因此，改进的电极材料将有益于当前和未来的DBS系统。Platinum Group Coatings LLC开发了一种具有成本效益和材料效率的工艺，用于将超低阻抗铂铱合金涂层应用到DBS刺激器电极的触点上。如果成功，这种涂层将通过允许显著更小的电极来提供相同或增强的性能，从而实现下一代刺激装置。此外，该工艺将使柔性电路基板上的微制造引线成为可能。本第一阶段研究将对DBS器械应用的这些涂层进行可行性研究。第一阶段的目标包括在临床DBS电极上沉积各种PtIr膜，膜的电气和机械评价，以及改性电极的长期脉冲。将使用标准电化学技术和外科植入方法（在脑模型中）进行评价。

DESCRIPTION (provided by applicant): 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 dimentia. DBS devices belong to a class of devices called implantable electrical stimulators, and close to 1 Million of these devices are implanted annually. These devices use electrodes in contact with tissue to deliver electrical pulses to targeted cells, to elicit specific therapeutic responses. Devices must be replaced as batteries wear down, thus improvements in device efficiency will extend device lifetime and reduce the number of replacement surgeries. 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 precisely target brain stem region to improve therapy. In general, the neuromodulation industry has been evolving towards smaller, less invasive electrodes. Thus, there are strong clinical, engineering and power motivations for moving towards smaller 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 electrodes. If successful, this coating will enable next generation stimulation devices by allowing for significantly smaller electrodes to provide the same or enhanced performance. Additionally, this process will enable microfabricated leads on flex-circuit substrates. This phase-I research will perform a feasibility study of these coatings for the DBS device application. The objectives for phase I include deposition of a variety of PtIr films on clinical DBS electrodes, electrical and mechanical evaluation of the films, and long-term pulsing of modified electrodes. Standard electrochemical techniques and surgical implant methods (in a brain model) will be used for evaluation.