Active Distributed Electrode Array Network for Electrical Stimulation Therapy

描述(由申请人提供)：近年来，涉及大量刺激肌肉的经皮电刺激应用一直是一个越来越感兴趣的领域。近几个月来，研究小组和刺激应用开发商与CustomKYnetics接洽，要求在他们的脊髓损伤康复研究和产品中使用高通道数刺激设备。现有设备不提供这些应用所需的特征和/或数量的刺激通道。由于刺激器的大小和复杂性以及任何特定配置的市场有限，这种高通道计数设备通常成本过高。现有的设备缺乏以特定用途的方式协调电极对活动的技术能力。这类应用也缺乏临床接受度，因为管理大量的导线既繁琐又不切实际。我们提出了新的有源分布式电极阵列(ADEA)技术，通过允许申请者共享两个通道刺激单元的输出来解决这些问题，从而形成一个基本上具有无限数量的虚拟刺激通道的刺激器。只需连接额外的低成本、模块化“刺激节点”，即可添加或删除虚拟通道。节点将以菊花链的方式相互连接，以最大限度地减少繁琐的布线。CK200将提供刺激控制能力，以在任何应用中部署电刺激模式，无论其复杂性如何。这项技术将使高通道数刺激应用能够用于运动和康复，提高效率，降低成本，并改善可用性。该第一阶段SBIR项目的目标是通过开发和平台测试概念验证版本的ADEA电路来证明ADEA技术的可行性。在第二阶段，我们将开发临床可行的刺激节点、刺激单元的应用固件和用户界面设计。我们将在一个或多个基于高通道数电刺激的运动和/或康复应用程序中展示该技术的有效性，这些应用程序适用于脊髓损伤患者。此外，我们还将考虑开发一种专用集成电路(ASIC)，以在一个小而轻的封装中实现刺激节点，该封装可以使用橡皮筋或粘合在刺激电极上，轻松地安装在电极部位。这种设备的目标市场将是为脊髓损伤或中风后接受康复治疗的患者提供服务的诊所，以及为这些人群服务的电刺激应用程序开发人员。对于8通道配置，该系统的目标价格将为3000美元。公共卫生相关性：拟议的工作可能会通过开发一种临床上可行的电刺激技术来造福公众健康，用于各种康复应用。与现有的设备和技术相比，该技术可以提高疗效、可用性、易用性，并降低治疗干预的成本，这些干预需要以良好控制/协调的方式使用电刺激激活大量肌肉。

DESCRIPTION (provided by applicant): Transcutaneous electrical stimulation applications involving high numbers of stimulated muscles have been an area of growing interest in recent years. customKYnetics has been approached in recent months by research groups and stimulation application developers requesting high channel count stimulation devices for use in their spinal cord injury rehabilitation research studies and products. Existing devices do not offer the features and/or number of stimulation channels required for these applications. Such high channel count devices are often cost prohibitive due to the size and complexity of the stimulator and the limited market for any particular configuration. Devices that are available lack the technological capability to coordinate the activity of the electrode pairs in an application-specific manner. Such applications have also lacked clinical acceptance because managing the large number of wires has been burdensome and impractical. We propose the novel Active Distributed Electrode Array (ADEA) technology that solves these problems by allowing the outputs of the applicants 2-channel stimulation unit to be shared thereby forming a stimulator with an essentially unlimited number of virtual stimulation channels. Virtual channels can be added or removed simply by connecting additional low cost, modular 'stimulation nodes'. Nodes will be connected to one another in a daisy-chain fashion to minimize burdensome wiring. The CK200 will provide the stimulation control capability to deploy the electrical stimulation modality in any application, no matter the complexity. This technology will enable, improve efficacy of, reduce cost, and improve availability of high channel count stimulation applications for exercise and rehabilitation. The goals of this Phase I SBIR project will be to demonstrate feasibility of ADEA technology through development and bench testing of concept validation versions of ADEA circuits. In Phase II we will develop clinically viable stimulation nodes, application firmware for the stimulation unit, and user interface designs. We will demonstrate efficacy of the technology in one or more high channel count electrical stimulation based exercise and/or rehabilitation applications for individuals with spinal cord injury. We will additionally consider development of an application specific integrated circuit (ASIC) to implement the stimulation node in a small and lightweight package that can be easily donned at the electrode site using either a elastic band or adhesively to the stimulating electrode itself. The target markets for this device would be clinics who serve patients undergoing rehabilitation following spinal cord injury or stroke and electrical stimulation application developers who serve these populations. The target price for the system will be $3000 for an 8-channel configuration. PUBLIC HEALTH RELEVANCE: The proposed work may benefit public health through development of a clinically viable electrical stimulation technology for use in myriad rehabilitation applications. Compared to existing devices and techniques, the technology may improve efficacy, availability, ease of use, and reduce cost of the therapeutic interventions requiring high numbers of muscles to be activated using electrical stimulation in a well controlled / coordinated fashion.