Adaptation and Extension of Wireless Wearable Patch System for Non-invasive Measurement of Myoelectric Signals from Gastrointestinal Organs

该项目将提供一个非侵入性的，无线的，可穿戴的基于补丁的系统 测量主要消化器官-胃、小肠和结肠-的运动活动 连续三天以上。这些器官的运动活动驱动胃肠(GI)运动，这是 是胃肠道功能的基础，因此参与了许多疾病和 功能障碍。一些例子包括肠易激综合征、炎症性肠病和 家庭使用方案中的胃轻瘫，以及手术后肠梗阻和肠道喂养不耐受 医院环境。 这项工作包括对原型系统的升级和扩展，该原型系统已在多个 涉及200多名患者的临床试验，既有医院的，也有完全门诊的。升级将 根据FDA的指导方针，解决原型性能和生产准备情况方面的限制。 这些扩展程序专门用于支持SPARC合作伙伴团队从事神经刺激工作 研究，并将适用于中等大小的动物模型以及人类。 具体目标涉及构成完整系统的子系统的工程，即补丁 机械硬件；获取原始肌电数据、将其数字化并传输的内部电子设备 到移动设备；在移动设备上运行的将原始数据传输到云服务器的应用程序； 数据分析软件，处理单个数据集并提取运动活动结果；以及 队列分析软件，汇总多项测试的结果，并提供研究趋势的工具 以及相互关系。 其他目标包括在动物模型(狗、小型猪、猪)上对该系统进行早期测试 演示获取类似数据以供SPARC合作伙伴团队开发和使用的可行性 测试他们的干预措施，以评估有效性、优化参数并了解它们如何影响 全胃肠道的运动活动。早期研究将为工程任务提供反馈，以便 最终的系统将在动物模型中有效，并最终可用于动物的常规使用，如 就像人类一样。

This project will deliver a non-invasive, wireless, wearable patch based system for objectively measuring motor activity of the major digestive organs – stomach, small intestine and colon – continuously over three days. Motor activity of these organs drive gastrointestinal (GI) motility, which is fundamental to performance of the GI tract, and is therefore involved in numerous disorders and dysfunctions. Some examples are Irritable Bowel Syndrome, Inflammatory Bowel Disease, and gastroparesis in the home use scenario, and post-operative ileus and enteral feeding intolerance in the hospital milieu. The work consists of upgrades and extensions to a prototype system that has been used in multiple clinical trials involving over 200 patients, in both hospital and fully ambulatory settings. Upgrades will address limitations in the prototype performance and readiness for manufacturing under FDA guidelines. The extensions are specific to use in support of SPARC partner teams working on neuro-stimulation research, and will apply to medium size animal models as well as humans. Specific aims relate to engineering of sub-systems that constitute the full system, the patch mechanical hardware; the internal electronics that acquire raw myoelectric data, digitize it and transmit it to a mobile device; the app that runs on the mobile device that transfers the raw data to a cloud server; the data analysis software that processes individual data sets and extracts motor activity results; and the cohort analysis software that aggregates results from multiple tests and provides tools for studying trends and correlations. Additional aims include early tests of the system on animal models (dogs, mini-pig, pigs) to demonstrate the feasibility of acquiring similar data for use by SPARC partner teams developing and testing their interventions, to assess the efficacy, optimize parameters, and learn about how they affect motor activity of the full GI tract. The early studies will provide feedback to the engineering tasks so that the final system will be effective in animal models and ultimately available for routine use in animals as well as humans.