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接受持续的电子子宫活动监测。通常，使用外部测力仪(应变计)来提供子宫收缩的频率和时间。对于一些患者，特别是肥胖者，监护仪无法持续检测到宫缩。在其他情况下，监护仪需要护理人员频繁地重新定位。唯一可用的替代方法是侵入性宫内压力导管(IUPC)，与其相关的感染风险增加。在美国，产科套房受到肥胖大流行的影响，这些女性出现分娩问题、感染和其他并发症的风险增加。这项拟议研究的具体目标是开发一种可靠的、非侵入性的子宫活动监测器，它不受肥胖的影响，需要的护理干预比产力计更少。最终产品将是一种名为eToco的智能EHG电缆，它可以将子宫的电活动(宫电或EHG)转换为与现有监护仪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，提供更健壮和可靠的收缩曲线，所需的护理干预更少，患者舒适度更高。阶段I结果表明，EHG可以提供这样一个简单的四电极阵列的监视器。电极阵列将是带有粘性衬垫的单一网状，以便于放置。本项目提出了以下具体目标：目标1：建立生产当量样机，以替代EHG硬件、软件和电极网-将根据第一阶段找到的最佳定位设计并制作电极网/阵列的原型。此外，将设计和建造eToco系统的生产当量硬件和嵌入式软件。为了支持FDA的批准，将在产品设计期间启动质量体系。目的2：临床评价MESH EHG子宫活动监测仪-所有数据将按照FDA良好临床实践(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名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这三个信号的解释，以确保相似性。目标3：为提交FDA 510(K)的TOCO替代系统做准备--所有必要的质量控制系统将在该项目期间实施。此外，还将编写510(K)提交书。目标4：用于胎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替代超声胎心率传感器。一种原型声学传感器将作为一种非侵入性监测胎儿心率的新方法进行测试。 公共卫生相关性：目前对子宫活动的非侵入性监测方法经常失败，特别是在肥胖患者中。当这种情况发生时，临床医生通常必须使用侵入性宫内压力导管，这在这些患者中尤其有问题，因为他们已经面临着更高的感染风险。开发一种替代的、廉价的传感器替代技术，使现有的监测器能够非侵入性地监测子宫活动，将改善诊断数据，减少所需的护理干预，并通过限制侵入性监测的需求减少感染并发症。

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.