A multi-channel stimulator with an active electrode array implant for vagal-cardiac neuromodulation studies.

Fangqi Liu, Maryam Habibollahi, Yu Wu, Nazanin Neshatvar, Jiaxing Zhang, Ciro Zinno, Outman Akouissi, Fabio Bernini, Lisa Alibrandi, Khatia Gabisonia, Vincenzo Lionetti, Jacopo Carpaneto, Henry Lancashire, Dai Jiang, Silvestro Micera, Andreas Demosthenous
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Abstract

Background: Implantable vagus nerve stimulation is a promising approach for restoring autonomic cardiovascular functions after heart transplantation. For successful treatment a system should have multiple electrodes to deliver precise stimulation and complex neuromodulation patterns.

Methods: This paper presents an implantable multi-channel stimulation system for vagal-cardiac neuromodulation studies in swine species. The system comprises an active electrode array implant percutaneously connected to an external wearable controller. The active electrode array implant has an integrated stimulator ASIC mounted on a ceramic substrate connected to an intraneural electrode array via micro-rivet bonding. The implant is silicone encapsulated for biocompatibility and implanted lifetime. The stimulation parameters are remotely transmitted via a Bluetooth telemetry link.

Results: The size of the encapsulated active electrode array implant is 8 mm × 10 mm × 3 mm. The stimulator ASIC has 10-bit current amplitude resolution and 16 independent output channels, each capable of delivering up to 550 µA stimulus current and a maximum voltage of 20 V. The active electrode array implant was subjected to in vitro accelerated lifetime testing at 70 °C for 7 days with no degradation in performance. After over 2 h continuous stimulation, the surface temperature change of the implant was less than 0.5 °C. In addition, in vivo testing on the sciatic nerve of a male Göttingen minipig demonstrated that the implant could effectively elicit an EMG response that grew progressively stronger on increasing the amplitude of the stimulation.

Conclusions: The multi-channel stimulator is suitable for long term implantation. It shows potential as a useful tool in vagal-cardiac neuromodulation studies in animal models for restoring autonomic cardiovascular functions after heart transplantation.

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用于迷走神经-心脏神经调制研究的多通道刺激器与主动电极阵列植入物。
背景:植入式迷走神经刺激是心脏移植后恢复自主心血管功能的一种很有前景的方法。为了成功治疗,系统应具有多个电极,以提供精确的刺激和复杂的神经调控模式:本文介绍了一种用于猪迷走神经-心脏神经调控研究的植入式多通道刺激系统。该系统包括一个经皮连接到外部可穿戴控制器的有源电极阵列植入体。有源电极阵列植入体有一个集成刺激器 ASIC,安装在陶瓷基板上,通过微型铆钉与神经内电极阵列连接。植入体采用硅胶封装,具有生物相容性和植入寿命。刺激参数通过蓝牙遥测链路远程传输:封装有源电极阵列植入体的尺寸为 8 毫米 × 10 毫米 × 3 毫米。刺激器 ASIC 具有 10 位电流振幅分辨率和 16 个独立输出通道,每个通道可提供高达 550 µA 的刺激电流和 20 V 的最大电压。有源电极阵列植入体在 70 °C 下进行了 7 天的体外加速寿命测试,性能没有下降。连续刺激超过 2 小时后,植入体表面温度变化小于 0.5 °C。此外,在一只雄性哥廷根小型猪的坐骨神经上进行的体内测试表明,该植入物能有效地引起肌电图反应,随着刺激幅度的增加,肌电图反应逐渐增强:结论:多通道刺激器适合长期植入。结论:多通道刺激器适合长期植入,在心脏移植后恢复自律性心血管功能的动物模型迷走神经-心脏神经调控研究中具有潜力。
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8 weeks
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