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功能模块；此外，许多 其中一些使用封闭式架构(例如，使用定制ASIC，而不是商用现成的 组件)和专有软件。 因此，这个黄蜂自主神经记录和刺激中心的总体目标是 系统(CASS)是为自主神经开发一个开放架构和开源的植入性系统 刺激和记录。我们计划开发为生物电子量身定做的CASS植入式系统 医药应用。CARSS系统包括一个外部充电器和控制器，可植入脉冲 发电机，以及用于刺激和传感的各种可互操作和可植入的导线。因此，这是 无缝统一的系统将实现闭环传感和神经调节，提供实验性的 对临床研究社区的灵活性和可控性。 为了使开发的系统及其组件可供社区使用，我们的CASS中心 将与用户社区接触，并通过提供系统模板和 图书馆(连同辅助技术文档)以及培训。我们的中心目标是 传播方法是与社区合作，以减少技术、法规和财务方面的 进入生物电子医学研究的壁垒，从而加快开发和转化 新的生物电子医疗疗法。我们已经组建了一个来自产业界和学术界的协作团队，以 实现了一个适合于人类临床研究的CARSS系统。

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 functional modules for accessing the autonomic nerves; moreover, many of them use closed architectures (e.g., the use of custom ASICs instead of commercial over-the-shelf components) and proprietary software. Therefore, the overall objective of this HORNET Center for Autonomic Nerve Recording and Stimulation Systems (CARSS) is to develop an open-architecture and open-source implantable system for autonomic nerve stimulation and recording. We propose to develop the CARSS implantable system tailored for bioelectronic medicine applications. The CARSS system includes an external charger and controller, implantable pulse generator, and an assortment of interoperable and implantable leads for stimulation and sensing. As such, this seamlessly unified system will enable closed-loop sensing and neuromodulation, providing experimental flexibility and control to the clinical research community. In order to make the developed system and its components available to the community, our CARSS Center will engage with the user community and facilitate technology dissemination by providing system templates and libraries (along with supporting technical documentation) as well as training. The central goal of our dissemination approach is to collaborate with the community to reduce the technical, regulatory, and financial barriers to entry into bioelectronic medicine research and thereby accelerate the development and translation of novel bioelectronic medical therapies. We have assembled a collaborative team from industry and academia to achieve a CARSS system suitable for use in human clinical research.