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

HORNET 自主神经记录和刺激系统中心 (CARSS)

• 批准号: 10706616
• 负责人: Victor Pikov
• 金额: $ 43万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-23 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10706616
• 关键词: Address; Affect; Algorithms; Architecture; Automobile Driving; Behavior; Charge; Classification; Clinical; Clinical Research; Communication; Complex; Computer software; Custom; Data; Detection; Development; Devices; Dimensions; Ecosystem; Electrocardiogram; Electronics; Ensure; Exhibits; Face; Goals; Implant; Individual; Laws; Medicine; Monitor; Noise; Patients; Performance; Physiologic pulse; Play; Power Sources; Process; Property; Research Personnel; Risk; Safety; Secure; Signal Transduction; Standardization; System; Technology; Testing; Time; Transistors; analog; artificial neural network; autonomic nerve; battery recharging; bioelectronics; design; digital; engineering design; experience; flexibility; high risk; implant design; improved; innovation; interest; neuroregulation; open source; operation; preference; prevent; programs; signal processing; voltage

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.

尽管人们对生物电子医学应用的临床研究有着广泛的兴趣，但 没有可用的开放架构和开源植入系统用于自主神经刺激和 记录。因此，临床研究人员在获得药物方面面临着重大的技术、监管和财务障碍。 获得进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植入式神经调节系统可用，它们具有 有助于支持临床研究。然而，就目前的形式而言，没有一个适合生物电子学 医学应用，因为它们缺乏访问自主神经的关键模块；此外，他们中的许多人 使用封闭架构和专有软件。 为了应对这一挑战，我们建议开发植入式脉冲发生器的 PCBA 和固件 （IPG）平台和外部充电器，它将基于灵活的开放架构、开源和 模块化方法。这种灵活性将允许针对不同的临床适应症进行显着程度的定制， 包括开环和闭环 IPG 操作。 PCBA 和固件模块将设计用于 与多种传感和刺激引线连接。一旦 IPG 和充电器模块安装完毕 开发完成后，它们将接受台式测试。