Nano-Micro Letters ( IF 31.6 ) Pub Date : 2022-06-14 , DOI: 10.1007/s40820-022-00870-0 Junshi Li 1 , Yundong Ma 2 , Dong Huang 1, 3, 4 , Zhongyan Wang 1 , Zhitong Zhang 1 , Yingjie Ren 1 , Mengyue Hong 2 , Yufeng Chen 1 , Tingyu Li 1 , Xiaoyi Shi 1 , Lu Cao 1, 5 , Jiayan Zhang 1 , Bingli Jiao 3 , Junhua Liu 1 , Hongqiang Sun 2 , Zhihong Li 1
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Highlights
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Polyimide-based flexible microneedle array (PI-MNA) electrodes realize high electrical/mechanical performance and are compatible with wearable wireless recording systems.
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The normalized electrode–skin interface impedance (EII) of the PI-MNA electrodes reaches 0.98 kΩ cm2 at 1 kHz and 1.50 kΩ cm2 at 10 Hz, approximately 1/250 of clinical standard electrodes.
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This is the first report on the clinical study of microneedle electrodes. The PI-MNA electrodes are applied to clinical long-term continuous monitoring for polysomnography.
Abstract
Microneedle array (MNA) electrodes are an effective solution to achieve high-quality surface biopotential recording without the coordination of conductive gel and are thus very suitable for long-term wearable applications. Existing schemes are limited by flexibility, biosafety, and manufacturing costs, which create large barriers for wider applications. Here, we present a novel flexible MNA electrode that can simultaneously achieve flexibility of the substrate to fit a curved body surface, robustness of microneedles to penetrate the skin without fracture, and a simplified process to allow mass production. The compatibility with wearable wireless systems and the short preparation time of the electrodes significantly improves the comfort and convenience of electrophysiological recording. The normalized electrode–skin contact impedance reaches 0.98 kΩ cm2 at 1 kHz and 1.50 kΩ cm2 at 10 Hz, a record low value compared to previous reports and approximately 1/250 of the standard electrodes. The morphology, biosafety, and electrical/mechanical properties are fully characterized, and wearable recordings with a high signal-to-noise ratio and low motion artifacts are realized. The first reported clinical study of microneedle electrodes for surface electrophysiological monitoring was conducted in tens of healthy and sleep-disordered subjects with 44 nights of recording (over 8 h per night), providing substantial evidence that the electrodes can be leveraged to substitute for clinical standard electrodes.
中文翻译：
高性能柔性微针阵列作为低阻抗表面生物电势干电极用于可穿戴电生理记录和多导睡眠图
强调
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基于聚酰亚胺的柔性微针阵列 (PI-MNA) 电极实现了高电气/机械性能，并与可穿戴无线记录系统兼容。
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PI-MNA 电极的归一化电极-皮肤界面阻抗 (EII) 在 1 kHz 时达到 0.98 kΩ cm 2 ，在 10 Hz 时达到1.50 kΩ cm 2，约为临床标准电极的 1/250。
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这是关于微针电极临床研究的第一份报告。PI-MNA电极应用于临床长期连续监测多导睡眠图。
抽象的
微针阵列（MNA）电极是无需导电凝胶配合即可实现高质量表面生物电势记录的有效解决方案，因此非常适合长期可穿戴应用。现有方案受到灵活性、生物安全性和制造成本的限制，这为更广泛的应用创造了巨大障碍。在这里，我们提出了一种新型的柔性 MNA 电极，它可以同时实现基板的柔韧性以适应弯曲的体表、微针的坚固性以穿透皮肤而不断裂，以及简化的过程以允许大规模生产。与可穿戴无线系统的兼容性和电极准备时间短显着提高了电生理记录的舒适性和便利性。归一化的电极-皮肤接触阻抗达到 0。在 1 kHz 时为 2，在 10 Hz 时为 1.50 kΩ cm 2 ，与之前的报告相比创历史新低，约为标准电极的 1/250。形态学、生物安全性和电气/机械特性得到充分表征，实现了具有高信噪比和低运动伪影的可穿戴记录。首次报道的用于表面电生理监测的微针电极临床研究是在数十名健康和睡眠障碍受试者中进行的，记录时间为 44 晚（每晚超过 8 小时），提供了大量证据表明电极可用于替代临床标准电极。
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