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。customKYnetics已经被研究小组和刺激应用开发人员接触，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。我们提出了主动分布式电极阵列（ADEA）技术，它提供了两个新特性来解决这些问题：网络架构和最终用户可编程性。有了这些功能，ADEA系统将由应用开发者（即研究人员、专业临床医生或OEM公司）完全配置（硬件和软件），以创建特定应用的刺激/传感网络和刺激方案。不需要终端用户编程经验。我们成功完成了第一阶段的工作，包括节点概念的可行性论证。二期SBIR项目的目标是开发临床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，并证明该技术的有效性。该设备的目标市场将是专业诊所、研究小组和OEM公司。对于8通道配置（OEM市场），该系统的目标价格为3000美元。

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).