Active Distributed Electrode Array Network for Electrical Stimulation Therapy

用于电刺激治疗的有源分布式电极阵列网络

• 批准号: 7745675
• 负责人: Eric C Hartman
• 金额: $ 9.95万
• 依托单位: CUSTOMKYNETICS, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-08-01 至 2012-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7745675
• 关键词: Area; Cations; Client; Clinic; Clinical; Complex; Custom; Data; Detection; Development; Development Plans; Devices; Electric Stimulation; Electrodes; Engineering; Exercise; Goals; Government; Individual; Institution; Lead; Marketing; Memory; Methods; Modality; Monitor; Muscle; Noise; Output; Pain management; Patients; Phase; Physiologic pulse; Population; Predisposition; Price; Problem Solving; Protocols documentation; Public Health; Rehabilitation Research; Rehabilitation therapy; Relative (related person); Research; Site; Skeletal Muscle; Small Business Innovation Research Grant; Spinal cord injury; Stream; Stroke; Subgroup; System; Technology; Testing; Therapeutic Intervention; Time; Training; Transcutaneous Electric Nerve Stimulation; Validation; Width; Work; base; cost; design; improved; interest; light weight; neuromuscular; novel; public health relevance; research and development; research study; technology/technique; virtual

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.

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，研究小组和刺激应用开发者已经接触了customKYnetics，要求在他们的脊髓损伤康复研究和产品中使用高通道计数刺激设备。现有设备不提供这些应用所需的刺激通道的特征和/或数量。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，这种高通道数装置通常成本过高。可用的设备缺乏以应用特定的方式协调电极对的活动的技术能力。这样的应用还缺乏临床接受度，因为管理大量的线是繁重且不切实际的。我们提出了新颖的有源分布式电极阵列（ADEA）技术，其通过允许申请人的2通道刺激单元的输出被共享从而形成具有基本上无限数量的虚拟刺激通道的刺激器来解决这些问题。虚拟通道可以简单地通过连接额外的低成本、模块化“刺激节点”来添加或移除。节点将以菊花链方式相互连接，以最大限度地减少繁琐的布线。CK 200将提供刺激控制功能，以在任何应用中部署电刺激模态，无论其复杂性如何。该技术将能够提高用于锻炼和康复的高通道数刺激应用的功效、降低成本并提高其可用性。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II阶段，我们将开发临床上可行的刺激节点、刺激单元的应用固件和用户界面设计。我们将证明该技术在一个或多个基于高通道数电刺激的运动和/或脊髓损伤患者康复应用中的有效性。我们还将考虑开发专用集成电路（ASIC），以在小型轻量化包装中实现刺激节点，该包装可以使用弹性带或固定在刺激电极本身上轻松地穿戴在电极部位。该器械的目标市场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，以及为这些人群提供服务的电刺激应用程序开发人员。该系统的目标价格将是3000美元的8通道配置。公共卫生关系：拟议的工作可能有利于公众健康，通过开发一种临床上可行的电刺激技术，用于无数的康复应用。与现有的装置和技术相比，该技术可以提高疗效、可用性、易用性，并降低需要以良好控制/协调的方式使用电刺激激活大量肌肉的治疗干预的成本。