Department of Bioengineering, University of Utah, Salt Lake City, UT, United States of America.
J Neural Eng. 2017 Aug;14(4):046011. doi: 10.1088/1741-2552/aa69d3.
Performance of many dielectric coatings for neural electrodes degrades over time, contributing to loss of neural signals and evoked percepts. Studies using planar test substrates have found that a novel bilayer coating of atomic-layer deposited (ALD) AlO and parylene C is a promising candidate for neural electrode applications, exhibiting superior stability to parylene C alone. However, initial results from bilayer encapsulation testing on non-planar devices have been less positive. Our aim was to evaluate ALD AlO-parylene C coatings using novel test paradigms, to rigorously evaluate dielectric coatings for neural electrode applications by incorporating neural electrode topography into test structure design.
Five test devices incorporated three distinct topographical features common to neural electrodes, derived from the utah electrode array (UEA). Devices with bilayer (52 nm AlO + 6 µm parylene C) were evaluated against parylene C controls (N ⩾ 6 per device type). Devices were aged in phosphate buffered saline at 67 °C for up to 311 d, and monitored through: (1) leakage current to evaluate encapsulation lifetimes (>1 nA during 5VDC bias indicated failure), and (2) wideband (1-10 Hz) impedance.
Mean-times-to-failure (MTTFs) ranged from 12 to 506 d for bilayer-coated devices, versus 10 to >2310 d for controls. Statistical testing (log-rank test, α = 0.05) of failure rates gave mixed results but favored the control condition. After failure, impedance loss for bilayer devices continued for months and manifested across the entire spectrum, whereas the effect was self-limiting after several days, and restricted to frequencies <100 Hz for controls. These results correlated well with observations of UEAs encapsulated with bilayer and control films.
We observed encapsulation failure modes and behaviors comparable to neural electrode performance which were undetected in studies with planar test devices. We found the impact of parylene C defects to be exacerbated by ALD AlO, and conclude that inferior bilayer performance arises from degradation of ALD AlO when directly exposed to saline. This is an important consideration, given that neural electrodes with bilayer coatings are expected to have ALD AlO exposed at dielectric boundaries that delineate electrode sites. Process improvements and use of different inorganic coatings to decrease dissolution in physiological fluids may improve performance. Testing frameworks which take neural electrode complexities into account will be well suited to reliably evaluate such encapsulation schemes.
许多用于神经电极的介电涂层的性能会随时间退化,导致神经信号和诱发感知的损失。使用平面测试衬底的研究发现,原子层沉积(ALD)AlO 和聚对二甲苯 C 的新型双层涂层是神经电极应用的有前途的候选材料,其稳定性优于单独的聚对二甲苯 C。然而,在非平面设备上进行双层封装测试的初步结果并不那么乐观。我们的目标是使用新的测试范例来评估 ALD AlO-聚对二甲苯 C 涂层,通过将神经电极拓扑结构纳入测试结构设计,严格评估神经电极应用的介电涂层。
五个测试设备结合了源自犹他电极阵列(UEA)的三种常见的神经电极的独特拓扑特征。对具有双层(52nm AlO+6μm 聚对二甲苯 C)的设备与聚对二甲苯 C 对照(每种设备类型 N≥6)进行了评估。设备在 67°C 的磷酸盐缓冲盐中老化,最长可达 311 天,并通过以下方式进行监测:(1)漏电流评估封装寿命(在 5VDC 偏压下超过 1nA 表示失效),以及(2)宽带(1-10Hz)阻抗。
双层涂层设备的平均故障时间(MTTF)范围为 12 至 506 天,而对照设备的范围为 10 至>2310 天。故障速率的统计检验(对数秩检验,α=0.05)得出的结果喜忧参半,但有利于对照条件。失效后,双层设备的阻抗损耗持续数月,并在整个频谱上表现出来,而对照设备的影响在几天后就自我限制,并且仅限于<100Hz 的频率。这些结果与用双层和对照薄膜封装的 UEA 的观察结果非常吻合。
我们观察到与神经电极性能相当的封装失效模式和行为,而这些在使用平面测试设备的研究中未被检测到。我们发现,ALD AlO 加剧了聚对二甲苯 C 缺陷的影响,并且得出结论,当直接暴露在盐水中时,ALD AlO 的降解导致双层性能下降。这是一个重要的考虑因素,因为预计具有双层涂层的神经电极在界定电极位置的介电边界处将暴露有 ALD AlO。改进工艺并使用不同的无机涂层来减少在生理流体中的溶解可能会提高性能。考虑到神经电极复杂性的测试框架将非常适合可靠地评估这种封装方案。