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 使用封闭式架构和专有软件。 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PCBA和固件 (IPG)平台和外部充电器，将基于灵活、开放架构、开源和 模块化方法。这种灵活性将允许对不同的临床适应症进行很大程度的定制， 包括开环IPG运行和闭环IPG运行。PCBA和固件模块将设计用于 与大量的传感和刺激引线连接。一旦IPG和充电器模块 开发完成后，它们将接受台式测试。

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 and proprietary software. To address this challenge, we propose to develop the PCBA and firmware for the implantable pulse generator (IPG) platform and external charger, which will be based on a flexible, open-architecture, open-source, and modular approach. Such flexibility will allow a significant degree of customization for different clinical indications, including open-loop and closed-loop IPG operation. The PCBA and firmware modules will be designed for interfacing with a large selection of sensing and stimulation leads. Once the IPG and charger modules are developed, they will be subjected to the benchtop testing.