Ong Samuel, Kullmann Aura, Mertens Steve, Rosa Dave, Diaz-Botia Camilo A
NeuroOne Medical Technologies Corporation, Eden Prairie, MN 55344, USA.
Micromachines (Basel). 2022 Oct 21;13(10):1798. doi: 10.3390/mi13101798.
Subdural electrode arrays are used for monitoring cortical activity and functional brain mapping in patients with seizures. Until recently, the only commercially available arrays were silicone-based, whose thickness and lack of conformability could impact their performance. We designed, characterized, manufactured, and obtained FDA clearance for 29-day clinical use (510(k) K192764) of a new thin-film polyimide-based electrode array. This study describes the electrochemical characterization undertaken to evaluate the quality and reliability of electrical signal recordings and stimulation of these new arrays. Two testing paradigms were performed: a short-term active soak with electrical stimulation and a 29-day passive soak. Before and after each testing paradigm, the arrays were evaluated for their electrical performance using Electrochemical Impedance Spectroscopy (EIS), Cyclic Voltammetry (CV) and Voltage Transients (VT). In all tests, the impedance remained within an acceptable range across all frequencies. The different CV curves showed no significant changes in shape or area, which is indicative of stable electrode material. The electrode polarization remained within appropriate limits to avoid hydrolysis.
硬膜下电极阵列用于监测癫痫患者的皮质活动和脑功能图谱。直到最近，唯一可商购的阵列是硅基的，其厚度和缺乏贴合性可能会影响其性能。我们设计、表征、制造了一种新型的基于聚酰亚胺薄膜的电极阵列，并获得了美国食品药品监督管理局（FDA）为期29天临床使用（510(k) K192764）的许可。本研究描述了为评估这些新阵列电信号记录和刺激的质量与可靠性而进行的电化学表征。进行了两种测试范式：电刺激短期活性浸泡和29天被动浸泡。在每种测试范式前后，使用电化学阻抗谱（EIS）、循环伏安法（CV）和电压瞬变（VT）评估阵列的电性能。在所有测试中，阻抗在所有频率范围内均保持在可接受范围内。不同的CV曲线在形状或面积上没有显著变化，这表明电极材料稳定。电极极化保持在适当限度内以避免水解。
