Active Distributed Electrode Array Network for Electrical Stimulation Therapy

描述（由申请人提供）：近年来，涉及大量受刺激肌肉的经皮电刺激应用已成为一个越来越受关注的领域。近几个月来，一些研究小组和刺激应用开发商与customKYnetics进行了接触，要求将高通道数的刺激设备用于他们的脊髓损伤康复研究和产品。现有设备不具备这些应用所需的功能和/或刺激通道数量。由于刺激器的尺寸和复杂性以及任何特定配置的有限市场，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应用方式协调电极对活性的技术能力。这种应用也缺乏临床认可，因为管理大量的导线是繁重和不切实际的。我们提出了一种新的有源分布式电极阵列（ADEA）技术，该技术通过允许申请人的2通道刺激单元的输出共享来解决这些问题，从而形成一个具有基本上无限数量的虚拟刺激通道的刺激器。通过连接额外的低成本模块化“刺激节点”，可以简单地添加或删除虚拟通道。节点将以菊花链的方式相互连接，以尽量减少繁重的布线。CK200将提供增产控制能力，无论复杂程度如何，都可以在任何应用中部署电增产方式。该技术将提高运动和康复的效率，降低成本，提高高通道数刺激应用的可用性。第一阶段SBIR项目的目标是通过ADEA电路的概念验证版本的开发和台架测试来证明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。我们将展示该技术在一个或多个基于高通道数电刺激的脊髓损伤患者运动和/或康复应用中的有效性。此外，我们还将考虑开发一种专用集成电路（ASIC），将刺激节点安装在一个小而轻的封装中，可以使用松紧带或粘附在刺激电极上，轻松地安装在电极部位。该设备的目标市场是为脊髓损伤或中风患者提供康复服务的诊所，以及为这些人群服务的电刺激应用开发商。该系统的目标价格将是3000美元的8通道配置。公共卫生相关性：通过开发临床可行的电刺激技术用于无数康复应用，拟议的工作可能有益于公共卫生。与现有设备和技术相比，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，这些治疗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.