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

尽管人们对为生物电子医学应用进行临床研究有广泛的兴趣，但仍有 没有可用的开放架构和开放源码的植入式系统用于自主神经刺激和 正在录音。因此，临床研究人员面临着重大的技术、法规和财务障碍 获得进行这些临床研究所需的植入性神经调节技术。 目前有几种临床上可用的闭环式植入式神经调节系统，它们 有助于支持临床研究。然而，在它们目前的形式中，没有一种适合生物电子产品 医学应用，因为它们缺乏访问自主神经的关键模块；而且，其中许多 使用封闭式架构。 为了应对这一挑战，我们建议为植入式脉冲发生器开发可植入引线 (IPG)平台，它将基于灵活、开放的架构和模块化方法。一大批精选的 将开发用于与IPG接头对接的刺激和传感导线。具体来说，我们将发展 一种以聚二甲基硅氧烷为基础的袖带，用于刺激直径1毫米及以上的自主神经。我们 还将开发一种用于刺激骶神经的引线。为了实现闭环神经调节，我们将开发 心电图学、肌电图学、神经电图学和基于加速度计的运动导联 感官。这种灵活性和模块化将允许对不同临床应用进行很大程度的定制 适应症，包括开环和闭环IPG操作。一旦可植入导线被开发出来，他们 将接受台式测试。

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.