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。研究小组和刺激应用开发商已经与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。我们提出了有源分布式电极阵列(ADEA)技术，它提供了两个新的特征来解决这些问题：网络结构和最终用户的可编程性。有了这些功能，ADEA系统将可由应用程序开发商(即研究人员、专业临床医生或OEM公司)完全配置(硬件和软件)，以创建特定于应用程序的刺激/传感网络和刺激方案。不需要终端用户编程经验。我们成功地完成了第一阶段的工作，包括节点概念的可行性论证。这个第二阶段SBIR项目的目标是开发临床上可行的刺激和传感节点、ADEA刺激器/控制器模块和最终用户编程套件，并展示该技术的有效性。这种设备的目标市场将是专业诊所、研究集团和OEM公司。该系统的目标价格将为8通道配置(OEM市场)的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 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 Active Distributed Electrode Array (ADEA) technology, which offers two novel features that address these problems: network architecture and end-user programmability. With these features, the ADEA system will be fully configurable (both in hardware and software) by the application developer (i.e., researcher, specialized clinician, or OEM company) to create application-specific stimulation/sensing networks and stimulation regimens. No end-user programming experience will be required. We successfully completed Phase I work, including feasibility demonstration of the node concept. The goals of this Phase II SBIR project will be to develop clinically viable stimulation and sensing nodes, an ADEA stimulator/controller module, and an end-user programming suite, and to demonstrate efficacy of the technology. The target markets for this device will be specialized clinics, research groups, and OEM companies. The target price for the system will be $3000 in volume for an 8-channel configuration (OEM market). 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.