Development of Networked Implantable Neuroprostheses

描述（由申请人提供）： 神经假体装置是为患有中枢神经系统疾病（例如脊髓损伤和中风）的个体提供功能增强的强大工具。生命维持和改善功能，如呼吸，站立，行走，抓握，伸手，排尿和排便都已在临床上证明使用神经假体。现有的植入式神经假体系统利用大量的外部供电和信号处理，并且每个系统必须针对其预期的特定应用进行定制，这严重限制了该领域的进展并延迟了向最终用户引入新技术。我们的生物医学研究伙伴关系（BRP）项目通过开发网络化神经假体系统（NNPS）来解决这个问题。NNPS是基于一个小型植入模块的网络，分布在整个身体，并连接到一个集中的电源。这些模块通过网络电缆联网，该网络电缆从中央可充电锂离子电池向每个模块分配电力。每个模块都包含处理功能，通过网络电缆与其他模块通信，并可通过中央经皮链路在网络上重新编程。NNPS非常灵活，通过选择适当的模块，可满足广泛的神经假体应用的技术需求。 我们在当前BRP的前两年取得了重大进展，包括：解决需要新知识和/或技术的关键概念和设计（包括形成必要的合作伙伴关系），建立整体设计拓扑和要求，确定所需的系统组件（硬件和软件），开发网络通信协议，解决供电问题，以及启动硬件设计和原型。 在本拟议项目中，我们将：完成NNPS系统设计、制造组件、进行体外和体内鉴定和评价、开发基于研究和临床医生的软件工具，并启动人体受试者的可行性研究。我们将生产完整的功能系统，包括用于肌肉电刺激的刺激器，以及记录和处理肌电信号的传感器模块。在项目的第四年和第五年，我们将在脊髓损伤患者中实现NNPS的第一种配置，以提供增强的身体功能。该人体评价将证明NNPS的可行性，并将为NNPS更广泛的临床应用提供基础。我们相信NNPS是对神经假体领域的革命性贡献;它可以轻松配置用于当前和预期的神经假体应用，适应该领域参与者的新创新，消除外部组件，并可以使用微创手术技术实施。

DESCRIPTION (provided by applicant): Neuroprosthetic devices are powerful tools providing functional enhancement for individuals with central nervous system disorders, such as spinal cord injury and stroke. Life sustaining and improving functions such as breathing, standing, walking, grasping, reaching, micturition, and defecation have all been clinically demonstrated using neuroprostheses. Existing implanted neuroprosthetic systems utilize considerable external powering and signal processing, and each system must be customized to the specific application for which it is intended, severely limiting progress in the field and delaying the introduction of new technology to the end user. Our Biomedical Research Partnership (BRP) project addresses this issue through the development of a Networked Neuroprosthetic System (NNPS). The NNPS is based on a network of small implanted modules, distributed throughout the body, and linked to a centralized power source. The modules are networked through a network cable that distributes power to each module from a central rechargeable lithium-ion battery. Each module contains processing capabilities, communicates with other modules via the network cable, and is reprogrammable over the network via a central transcutaneous link. The NNPS is extremely flexible and meets the technical needs of a broad range of neuroprosthetic applications through the selection of the appropriate modules. We have made significant progress in the first two years of the current BRP including: addressing critical concepts and designs that required new knowledge and/or techniques (including forming the necessary partnerships), establishing overall design topology and requirements, identifying needed system components (hardware and software), developing network communication protocols, addressing powering issues, and initiating hardware designs and prototypes. In this proposed project we will: finalize the NNPS system design, fabricate components, conduct in-vitro and in-vivo qualification and evaluation, develop research and clinician based software tools, and initiate feasibility studies in human subjects. We will produce complete functional systems, including a stimulator for muscle-based electrical stimulation, and a sensor module that records and processes myoelectric signals. In the fourth and fifth years of the project, we will realize the first configurations of the NNPS in individuals with spinal cord injury to provide enhanced physical function. This human evaluation will demonstrate the feasibility of the NNPS and will provide the foundation for broader clinical application of the NNPS. We believe the NNPS is a revolutionary contribution to the field of neuroprosthetics; it is easily configured for current and anticipated neuroprosthetic applications, accommodates new innovations by participants in the field, eliminates external components, and can be implemented using minimally invasive surgical techniques.