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，可穿戴的补丁为基础的系统，客观 测量主要消化器官-胃、小肠和结肠-的运动活动， 连续三天。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，因此涉及许多疾病， 功能障碍一些例子是肠易激综合征，炎症性肠病， 家庭使用情况下的胃轻瘫，以及 医院环境 这项工作包括对一个原型系统的升级和扩展，该原型系统已在多个 临床试验涉及200多名患者，在医院和完全门诊设置。升级将 解决了原型性能的局限性，并根据FDA指南准备制造。 延伸导线专门用于支持神经刺激方面的合作伙伴团队 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， 机械硬件;采集原始肌电数据、存储并传输的内部电子设备 传输到移动终端;在移动终端上运行的将原始数据传输到云服务器的应用; 数据分析软件，其处理个体数据集并提取运动活动结果;以及 一种群组分析软件，它汇总了多个测试的结果，并提供了研究趋势的工具 和相关性。 其他目标包括该系统在动物模型（狗、迷你猪、猪）上的早期测试， 证明获取类似数据的可行性，供开发和使用的可持续发展伙伴团队使用， 测试他们的干预措施，以评估疗效，优化参数，并了解他们如何影响 整个胃肠道的运动活动。早期研究将为工程任务提供反馈， 最终的系统在动物模型中将是有效的 以及人类。

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.