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）：涉及大量受刺激肌肉的经皮电刺激应用近年来已成为人们日益感兴趣的领域。近几个月来，研究小组和刺激应用开发商已与 customKYnetics 接洽，要求将高通道数刺激设备用于他们的脊髓损伤康复研究和产品。现有设备不提供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，这种高通道数设备的成本通常过高。现有的设备缺乏以特定于应用的方式协调电极对的活动的技术能力。此类应用还缺乏临床接受度，因为管理大量电线既繁重又不切实际。我们提出了新颖的有源分布式电极阵列（ADEA）技术，该技术通过允许共享申请人的2通道刺激单元的输出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。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，以最大程度地减少繁琐的接线。 CK200 将提供刺激控制功能，以便在任何应用中部署电刺激模式，无论其复杂程度如何。该技术将提高运动和康复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，我们将开发临床上可行的刺激节点、刺激单元的应用固件以及用户界面设计。我们将在针对脊髓损伤患者的一个或多个基于高通道数电刺激的运动和/或康复应用中展示该技术的功效。我们还将考虑开发专用集成电路（ASIC），以在小而轻的封装中实现刺激节点，该封装可以使用松紧带或粘合到刺激电极本身轻松地戴在电极部位。该设备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开发商。 8 通道配置系统的目标价格为 3000 美元。公共健康相关性：拟议的工作可能通过开发临床上可行的电刺激技术用于多种康复应用而有益于公共健康。与现有的设备和技术相比，该技术可以提高功效、可用性、易用性，并降低需要使用电刺激以良好控制/协调的方式激活大量肌肉的治疗干预的成本。