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

项目总结最后--U41补编 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。在本行政补充中，我们将执行短期和长期验证 大小动物模型中系统组件的功能和安全性。CASS系统包括 外部充电器和控制器、可植入脉冲发生器以及各种可互操作和 用于刺激和感应的植入式导线。 胃和十二指肠被选作长期验证，与NIH的重点一致 SPARC程序。我们将在猪身上测试植入式脉冲发生器、迷走神经和骶神经刺激 导联、心电(ECG)导联、肌电(EMG)导联和基于加速度计的运动 感应(AMS)导联。我们剩下的导线，包括直径不到1毫米的神经的螺旋袖带， 机械感应导线和电化学传感器将在大鼠身上进行急性和慢性测试。这个 CARSS系统的电子模块将从外部连接到导线以执行刺激和 感官。

PROJECT SUMMARY FINAL – U41 Supplement 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. In this administrative supplement, we will perform short and long term validation of functionality and safety of system components in large and small animal models. The CARSS system includes an external charger and controller, implantable pulse generator, and an assortment of interoperable and implantable leads for stimulation and sensing. The stomach and duodenum were selected for long term validation, consistent with the focus of the NIH SPARC program. We will test in pig the implantable pulse generator, vagal nerve and sacral nerve stimulation leads, electrocardiographic (ECG) leads, electromyographic (EMG) leads, and accelerometer-based motion sensing (AMS) leads. Our remaining leads, including the helical cuff targeting nerves less than 1 mm in diameter, mechanical sensing leads, and electrochemical sensors, will be tested in rats acutely and then chronically. The electronics module for the CARSS system will be connected externally to the leads to perform stimulation and sensing.