HORNET Center for Autonomic Nerve Recording and Stimulation Systems (CARSS)

尽管人们对生物电子医学应用的临床研究有广泛的兴趣，但仍有 没有用于自主神经刺激的开放架构和开源植入式系统， 录制.因此，临床研究人员在获得技术、监管和财务方面面临重大障碍。 获得执行这些临床研究所需的植入式神经调节技术。 目前有几种临床闭环可植入神经调节系统，它们具有 有助于临床研究。然而，在他们目前的形式，没有一个是适合的生物电子 医学应用，因为它们缺乏访问自主神经的关键模块;此外，其中许多 使用封闭的体系结构。 为了应对这一挑战，我们建议开发用于植入式脉冲发生器的植入式电极导线 (IPG)该平台将以灵活、开放式架构和模块化方法为基础。一个大的选择 将开发刺激和感知电极导线，用于与IPG顶盖连接。具体来说，我们将开发 直径为1 mm或更大的用于刺激自主神经的基于聚二甲基硅氧烷的袖带。我们 还将开发一种用于骶神经刺激的电极导线。为了实现闭环神经调节，我们将开发 心电图、肌电图、神经电图和基于加速度计的运动的导联 感应这种灵活性和模块化将允许针对不同临床应用的显著程度的定制。 适应症，包括开环和闭环IPG操作。一旦植入式电极导线被开发出来， 将进行实验室测试。

Despite a wide-ranging interest in performing clinical research for bioelectronic medicine applications, there are no available open-architecture and open-source implantable systems for autonomic nerve stimulation and recording. As a result, clinical researchers face significant technical, regulatory, and financial hurdles in getting access to the implantable neuromodulation technologies that are required for performing these clinical studies. There are several clinical closed-loop implantable neuromodulation systems presently available and they have been helpful in supporting clinical research. However, in their current form, none are suitable for the bioelectronic medicine applications, as they lack key modules for accessing the autonomic nerves; moreover, many of them use closed architectures. To address this challenge, we propose to develop the implantable leads for the implantable pulse generator (IPG) platform, which will be based on a flexible, open-architecture, and modular approach. A large selection of stimulation and sensing leads will be developed for interfacing with the IPG header. Specifically, we will develop a polydimethylsiloxane-based cuff for stimulation of autonomic nerves with the diameter of 1 mm and larger. We will also develop a lead for sacral nerve stimulation. For enabling closed-loop neuromodulation, we will develop the leads for electrocardiographic, electromyographic, electroneurographic, and accelerometer-based motility sensing. Such flexibility and modularity will allow a significant degree of customization for different clinical indications, including open-loop and closed-loop IPG operation. Once the implantable leads are developed, they will be subjected to the benchtop testing.