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)的总体目标是 建立一个开源的、模块化的有源可植入设备网络，用于早期可行性人类 研究并通过一个充满活力的、可持续的活跃社区为这项技术提供持续支持 用户。我们的团队准备成功地实现大黄蜂计划的所有目标，因为我们的 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)。 这为我们的中芯国际大黄蜂项目提供了一个坚实的技术平台，具有已知的监管地位。 重要的是，这项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。 拟议的COSMIIC大黄蜂系统将建立在NNP平台系统上，是一个 一种可互操作的集成模块系统，可同时电激活、阻止和检测 遍及全身。该系统可以记录和处理神经电信号(ENG)、肌电(EMG)、 皮质内信号、心电图(EKG)、运动学变量、光体积图(PPG)和 温度。每个模块都可以通过已建立的网络与所有其他模块直接通信 通信协议。该系统可以对信号进行处理，实现复杂的闭环系统控制 需要非植入的硬件。重要的是，现有的NNP平台组件(电源模块， 刺激器模块、生物电势记录模块、网络电缆、电极)已获得IDE批准 FDA和已经成功地将其植入人体研究参与者体内并实施。因此， COSMIIC大黄蜂系统具有必要的功能，可提供模块化平台生态系统，供 在可预见的未来，生物电子社区。 目标1.传播。我们将建立COSMIIC社区，完全开放源代码访问 一种用于外周和中枢神经系统的已建立的模块化植入式装置。访问将 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、固件和引导加载程序的注释代码；的书面说明和视频 制造技术；以及所有法规文件和测试数据，包括我们批准的IDE文件。 目标2.可持续性。我们将通过开发一个可持续的开源模式 吸引了一支广泛的调查团队，以建立COSMIIC用户的临界数量的技术。我们会 提供持续的技术支持，并与商业合作伙伴合作，以创建可持续的 商业计划，以使中芯国际社区在三年后保持独立、充满活力和活跃。

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.