Cleveland Open Source Modular Implant Innovators Community (COSMIIC)

克利夫兰开源模块化植入物创新者社区 (COSMIIC)

• 批准号: 10701809
• 负责人: Cynthia Anne Chestek
• 金额: $ 434.68万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-10 至 2025-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10701809
• 关键词: Bladder; Blood Vessels; Brain; Businesses; Central Nervous System; Chemicals; Clinical; Code; Communication; Communities; Complex; Computer software; Data; Disease; Ecosystem; Education; Electric Stimulation; Electrocardiogram; Electrodes; Encapsulated; Endocrine; Future; Future Generations; Goals; Heart; Human; Implant; Instruction; Intellectual Property; Intestines; Knowledge; Letters; Licensing; Manufacturer; Mechanics; Modeling; Network Communication Protocols; Optics; Participant; Peripheral Nerves; Peripheral Nervous System; Process; Research; Research Personnel; Signal Transduction; Skeletal Muscle; Solid; Spinal Cord; System; Techniques; Technology; Technology Transfer; Temperature; Testing; Universities; Writing; bioelectronics; body system; clinical implementation; design; experience; fabrication; implantable device; innovation; interoperability; invention; kinematics; medical specialties; member; neuroprosthesis; neuroregulation; open source; permissiveness; programs; sensor; technology development; technology platform; ultrasound

The overall goal of the Cleveland Open Source Modular Implant Innovators Community (COSMIIC) is to establish an open source, modular network of active implantable devices for use in early feasibility human research and to provide ongoing support for this technology through a vibrant, sustainable community of active users. Our team is poised to successfully achieve all of the goals of the HORNET program because our proposed concept is based on our established platform ecosystem, the Networked Neuroprosthesis (NNP). This provides a solid technological platform with known regulatory status for our COSMIIC HORNET project. Critically, all technology described in this proposal was invented by the investigative team and therefore we are able to fully embrace the open source ideology for the end-to-end technology. The proposed COSMIIC HORNET System, which will be established on the platform NNP System, is a system of interoperable and integrated modules that can simultaneously electrically activate, block, and sense throughout the body. The system can record and process electroneurogram (ENG), electromyogram (EMG), intracortical signals, electrocardiogram (EKG), kinematic variables, photoplethysmogram (PPG), and temperature. Each module can directly communicate with all other modules through an established network communication protocol. The system can process signals to implement complex closed-loop control without requiring non-implanted hardware. Importantly, the existing NNP platform components (power module, stimulator module, biopotential recording module, network cable, electrodes) already have IDE approval from the FDA and have been successfully implanted and implemented in human research participants. Thus, the COSMIIC HORNET System has the necessary features to provide the modular platform ecosystem for use by the bioelectronic community for the foreseeable future. Aim #1. Dissemination. We will establish the COSMIIC community with full open-source access to an established modular implantable device for use in the peripheral and central nervous system. Access will be given for all circuit designs and layouts; mechanical drawings for all enclosures and connectors and cabling; the annotated code for all operating software, firmware, and bootloader; written instructions and videos of fabrication techniques; and all regulatory documents and test data, including our approved IDE document. Aim #2. Sustainability. We will develop a sustainable open source model through the development of technology that attracts a broad investigative team to establish a critical mass of COSMIIC users. We will provide ongoing support of the technology and partner with commercial partners to create a sustainable business plan so that the COSMIIC community remains independently vibrant and active after three years.

克利夫兰开源模块化种植体创新者社区（COSMIIC）的总体目标是 建立一个开放源代码的模块化网络，用于早期可行性人类 研究，并通过一个充满活力的，可持续的社区， 用户.我们的团队准备成功实现大黄蜂计划的所有目标，因为我们的 我们提出的概念是基于我们建立的平台生态系统，网络神经假体（NNP）。 这为我们的COSMIIC HORNET项目提供了一个具有已知监管状态的坚实技术平台。 关键是，该提案中描述的所有技术都是由调查小组发明的， 因此，我们能够完全接受端到端技术的开源思想。 拟议中的COSMIIC HORNET系统将建立在NNP系统平台上， 可同时电激活、阻断和感测的可互操作和集成模块的系统 在整个身体。该系统能记录和处理神经电图（ENG）、肌电图（EMG）、 皮质内信号、心电图（EKG）、运动学变量、光电容积描记图（PPG），以及 温度每个模块可以通过已建立的网络直接与所有其他模块通信 通信协议。该系统可以处理信号以实现复杂的闭环控制， 需要非植入硬件。重要的是，现有的NNP平台组件（电源模块， 刺激器模块、生物电位记录模块、网络电缆、电极）已经获得IDE批准， 并已成功植入并实施于人类研究参与者。因此 COSMIIC HORNET系统具有提供模块化平台生态系统的必要功能， 在可预见的未来，生物电子界。 目标1。传播。我们将建立一个COSMIIC社区， 一种用于外周和中枢神经系统的成熟模块化植入式器械。Access将 提供所有电路设计和布局;所有外壳、连接器和布线的机械图纸; 所有操作软件、固件和引导程序的注释代码; 制造技术;以及所有监管文件和测试数据，包括我们批准的IDE文件。 目标2。持续发展我们将通过以下方式发展可持续的开源模式： 这项技术吸引了一个广泛的调查小组，以建立一个临界质量的COSMIIC用户。我们将 提供持续的技术支持，并与商业合作伙伴合作， 商业计划，以便COSMIIC社区在三年后保持独立、充满活力和活跃。