Electrohysterogram-based sensor for non-invasive contraction monitoring with impr

描述（由申请人提供）：在美国，大多数产科分娩都要进行连续的电子子宫活动监测。通常情况下，使用外部子宫肌力计（应变计）来提供子宫收缩的频率和时间。在一些患者中，特别是肥胖患者，监测器无法持续检测到宫缩。在其他情况下，监护仪需要护理人员经常重新定位。唯一可用的替代方法是侵入性宫内压力导管（IUPC），其相关的感染风险增加。在美国，产科套房受到肥胖流行病的影响，这些女性出现分娩问题、感染和其他并发症的风险增加。该研究的具体目标是开发一种可靠的、无创的子宫活动监测仪，该监测仪不受肥胖的影响，比子宫测功仪需要更少的护理干预。最终产品将是一种名为eToco的“智能宫电电缆”，它将子宫的电活动（子宫电图或EHG）转换为与现有监视器兼容的子宫活动信号。eToco系统将插入现有监护仪的toco或IUP端口，提供更可靠的收缩曲线，所需的护理干预更少，提高了患者的舒适度。第一阶段的结果表明，EHG可以提供这样一个简单的四电极阵列监测。电极阵列将是一个单一的网状物，背面有粘合剂，便于放置。该项目提出了以下具体目标：目标1：构建生产等效原型以替代EHG硬件，软件和电极网格-电极网格/阵列将根据第一阶段找到的最佳定位设计和原型。此外，将设计和构建eToco系统的生产等效硬件和嵌入式软件。为了支持FDA批准，在产品设计期间将启动质量体系。目的2：临床评价网状EHG子宫活动监测仪-所有数据将按照FDA良好临床规范（GCP）的标准收集，并将足以提供统计学意义。临床研究分为两部分：第一部分将在130例患者中评估该系统与toco和IUP的对比，第二部分将评估熟练的临床医生对三种信号的解释，以确保相似性。目标3：准备提交FDA 510(k)用于toco-replacement系统-所有必要的质量控制系统将在该项目期间实施。此外，将准备510(k)提交。目标4：用于胎儿心率监测的声学传感器的初步测试-下一代产品将包括更可靠的超声FHR传感器替代品。一个原型声传感器将被测试作为一种新的方法，无创监测胎儿心率。

DESCRIPTION (provided by applicant): The majority of obstetric deliveries in the US undergo continuous electronic uterine activity monitoring. Typically, an external tocodynamometer (strain gauge) is employed to provide the frequency and timing of uterine contractions. In some patients, particularly the obese, the monitor fails to detect contractions consistently. In others the monitor requires frequent repositioning by the nursing staff. The only available alternative is an invasive intrauterine pressure catheter (IUPC), with its associated increased risk of infection. The obstetric suite is subject to the obesity pandemic in the US, and these women have an increased risk for labor problems, infections and other complications. The specific goal of the proposed research is to develop a reliable, non-invasive uterine activity monitor that is unaffected by obesity and requires less nursing intervention than the tocodynamometer. The end-product will be a "Smart EHG Cable", called the eToco that converts the electrical activity of the uterus (electrohysterogram or EHG) into uterine activity signals compatible with existing monitors. The eToco system will plug into the toco or IUP port of existing monitors and provide more robust and reliable contraction curves with less nursing intervention required and improved patient comfort. Phase I results indicate that the EHG can provide such a monitor with a simple four electrode array. The electrode array will be a single mesh with an adhesive backing for ease of placement. This project proposes the following specific aims: Aim 1: Build production-equivalent prototype toco-replacement EHG hardware, software, and electrode mesh - An electrode mesh/array will be designed and prototyped based on the optimal positioning found in Phase I. In addition, production-equivalent hardware and embedded software for the eToco system will be designed and built. To support FDA clearance, a quality system will be initiated during product design. Aim 2: Clinically evaluate the mesh EHG uterine activity monitor -All data will be collected to the standards of the FDA Good Clinical Practice (GCP) and will be sufficient to provide statistical significance. The clinical study is in two parts: the first will evaluate the system in 130 patients versus the toco and IUP and the second part will evaluate the interpretation of skilled clinicians on the three signals to ensure similarity. Aim 3: Preparation for submission of FDA 510(k) for toco-replacement system - all necessary quality control systems will be implemented during this project. In addition, the 510(k) submission will be prepared. Aim 4: Initial testing of an acoustic sensor for fetal heart rate monitoring - The next generation product will include a more reliable replacement for the ultrasound FHR sensor. A prototype acoustic sensor will be tested as a novel method for non-invasive monitoring of the fetal heart rate. PUBLIC HEALTH RELEVANCE: The current method of non-invasive monitoring of uterine activity fails frequently, particularly in the obese patient. When this occurs, often clinicians must use an invasive intra- uterine pressure catheter that is particularly problematic in these patients since they are already at increased risk for infections. The development of an alternative, inexpensive sensor replacement technology that allows for existing monitors to non-invasively monitor uterine activity will improve diagnostic data, reduce required nursing interventions, and reduce infectious complications by limiting the need for invasive monitoring.