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: 10706614
• 负责人: Raja Edward Hitti
• 金额: $ 49.63万
• 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/10706614
• 关键词: Address; Air; Algorithmic Software; Algorithms; Ally; Android; Architecture; Biochemical; Biological Markers; Blood; Bluetooth; Cellular Phone; Chemicals; Clinical; Clinical Research; Communication; Dedications; Development; Diagnostic Equipment; Disease; Effectiveness; Electrocardiogram; Exhalation; Explosion; Face; Galaxy; Galvanic Skin Response; Glucose; Implant; Individual; Lead; Mechanics; Medical Device; Medicine; Modality; Monitor; Operating System; Patients; Physical activity; Physiologic pulse; Physiological; Research Personnel; Respiration; Running; Sleep; System; Tablets; Technology; Telemetry; Temperature; Testing; autonomic nerve; bioelectronics; clinical diagnostics; design; electric impedance; experience; flexibility; interest; mathematical ability; neuroregulation; open source; operation; provider communication; sensor; wireless fidelity

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 mechanical modules for the implantable pulse generator (IPG) platform and external charger, which will be based on a flexible, open-architecture, 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 IPG 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 mechanical testing.

尽管对对生物电子医学应用进行临床研究的兴趣广泛，但仍有 没有可用的开放式结构和开源植入系统用于自主神经刺激和 记录。结果，临床研究人员面临着重大的技术，法规和财务障碍 访问进行这些临床研究所需的可植入神经调节技术。 目前有几种可用的临床闭环神经调节系统 有助于支持临床研究。但是，以目前的形式，不适合生物电子 医学应用，因为它们缺少用于访问自主神经的关键模块；而且，其中许多 使用封闭的体系结构。 为了应对这一挑战，我们建议开发可植入脉冲的机械模块 发电机（IPG）平台和外部充电器将基于灵活，开放式结构和模块化 方法。这种灵活性将允许对不同的临床适应症进行大量自定义， 包括开环和闭环IPG操作。 IPG模块将设计用于与A接口 大量的感应和刺激导线。一旦开发了IPG和充电器模块，他们将 进行台式机械测试。