Improved Electrode Material for Deep Brain Stimulation

描述(申请人提供)：在美国，迄今已有超过10万个脑深部刺激(DBS)设备被植入，用于治疗基本震颤、帕金森氏症和肌张力障碍，目前正在进行临床试验，以评估慢性疼痛、严重抑郁、偏头痛和肌张力障碍的适应症。DBS设备属于一种名为植入式电刺激器的设备，每年植入近100万台这样的设备。这些设备使用与组织接触的电极向目标细胞发送电脉冲，以引发特定的治疗反应。随着电池的磨损，必须更换设备，因此设备效率的提高将延长设备的寿命，减少更换手术的数量。虽然DBS在许多情况下有效，但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阵列可以精确地定位脑干区域，以提高治疗效果。总体而言，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、工程和动力动机转向更小的电极。然而，目前的电极材料在不严重限制刺激输出的情况下不支持小尺寸。因此，一种改进的电极材料将有益于现在和未来的DBS系统。铂族涂层有限责任公司开发了一种经济实惠、材料高效的工艺，用于在DBS刺激器电极的触点上涂覆超低阻抗铂-铱合金涂层。如果成功，这种涂层将允许更小的电极提供相同或增强的性能，从而使下一代刺激设备成为可能。此外，该工艺将在柔性电路基板上实现微制造引线。这项第一阶段的研究将对这些涂层应用于DBS设备进行可行性研究。第一阶段的目标包括在临床DBS电极上沉积各种PTIR膜，对膜进行电气和机械评估，以及对修饰电极进行长期脉冲处理。将使用标准的电化学技术和外科植入方法(在大脑模型中)进行评估。

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.