Electrodeposited Noble Metal Oxide Nerve Electrodes

描述（由申请人提供）： 电沉积氧化铱薄膜（EIROFs）作为低阻抗，高容量的电荷注入涂层的神经记录和刺激电极的发展。在第I阶段，通过定量组织学评价了植入家兔皮质的金属轴上的EIROF涂层的生物相容性，发现其与活性氧化铱（AIROF）和铱金属对照品相当。在60天植入期内，未观察到任何这些材料的不良神经病理学。体外测量建立了EIROF相关的神经记录和刺激的电化学性能，并提供了刺激电极的电荷注入限制。这些数据被用来确定神经假体和电刺激为基础的治疗，EIROF可以提供优于传统的金属电极或其他类型的电活性涂层。这些应用包括外周神经电极、耳蜗和视网膜感觉植入物以及皮质内刺激和记录电极。还确定了在基于刺激的治疗中的应用，如脑深部刺激和心脏起搏。EIROF相对于AIROF和其他竞争电极涂层的特殊优点是电沉积工艺简单，适用于涂覆神经假体中用作导体的大多数金属，以及显著降低的涂覆成本，同时对实施大批量涂覆操作所需的资本设备的投资最小。基于这些发现，II期研究的目标是：1）证明EIROF涂层的生物相容性和功能性能，用于使用植入皮质中长达一年的EIROF涂层Ptlr微电极进行长期慢性记录和刺激，2）广泛表征EIROF涂层相对于神经假体和基于刺激的治疗要求的电化学和机械性能，3）通过将EIROF结合到穿透的皮质内微电极、柔性电极阵列和微机械加工的硅基电极中来证明对广泛的神经假体的适用性，4）开发和证明EIROF沉积过程的放大，并建立用于在植入前处理和灭菌涂层的方案，和5）通过开发和提供用于EIROF涂层的体内使用、监测和维护的方案，促进最终用户和设备制造商采用EIROF，并通过在皮质中测试来验证这些方案。

DESCRIPTION (provided by applicant): The development of electrodeposited iridium oxide films (EIROFs) as low impedance, high-capacity charge-injection coatings for neural recording and stimulation electrodes is proposed. In Phase I, the biocompatibility of EIROF coatings on metal shafts implanted in rabbit cortex was evaluated by quantitative histology and found comparable with activated iridium oxide (AIROF) and iridium metal controls. No adverse neural pathology was observed with any of these materials for a 60 day implantation period. In vitro measurements established the electrochemical properties of EIROF relevant to neural recording and stimulation, and provided charge-injection limits for stimulation electrodes. These data were used to identify neuroprosthetic and electrical-stimulation based therapies for which EIROF could provide advantages over conventional metal electrodes or other types of electroactive coatings. The applications include peripheral nerve electrodes, cochlear and retinal sensory implants, and intracortical stimulation and recording electrodes. Applications in stimulation-based therapies such as deep-brain stimulation and cardiac pacing were also identified. The particular advantages of EIROF over AIROF and other competing electrode coatings are the simplicity of the electrodeposition process, suitability for coating most metals used as conductors in neural prostheses, and a significantly reduced coating cost with minimal investment in capital equipment required to implement high-volume coating operations. Based on these findings, the Phase II objectives are 1) to demonstrate biocompatibility and functional performance of EIROF coatings for long-term chronic recording and stimulation using EIROF-coated Ptlr microelectrodes implanted in cortex for periods up to one year, 2) to broadly characterize the electrochemical and mechanical properties of EIROF coatings relative to the requirements of neural prostheses and stimulation-based therapies, 3) to demonstrate suitability for a wide range of neural prostheses by incorporating EIROF into penetrating, intracortical microelectrodes, flexible electrode arrays, and micromachined silicon-based electrodes, 4) to develop and demonstrate scale-up of the EIROF deposition process and to establish protocols for handling and sterilization of coatings prior to implantation, and 5) to facilitate adoption of EIROF by end-users and device manufacturers by developing and providing protocols for in vivo use, monitoring and maintenance of EIROF coatings and to validate these protocols by testing in cortex.