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

基于宫腔电图的传感器，用于通过 impr 进行无创宫缩监测

• 批准号: 8001661
• 负责人: Neil R. Euliano
• 金额: $ 39.15万
• 依托单位: CONVERGENT ENGINEERING, INC.
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-06-15 至 2012-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8001661
• 关键词: Acoustics; Adhesives; Attention; Back; Catheters; Cervical; Clinical Research; Computer software; Data; Development; Diagnostic; Discipline of obstetrics; Documentation; Electrodes; Electronics; Ensure; Evaluation; Fetal Heart; Fetal Heart Rate; Frequencies; Goals; Good Clinical Practice; Individual; Infection; Marketing; Membrane; Methods; Monitor; Movement; Nature; Nurses; Nursing Staff; Obesity; Obstetric Delivery; Patients; Phase; Population; Positioning Attribute; Preparation; Production; Publications; Quality Control; Research; Risk; Rupture; Signal Transduction; System; Technology; Testing; Time; Ultrasonography; Uterine Contraction; Uterine Monitoring; Uterus; Validation; Woman; Work; base; design; experience; fetal; improved; next generation; non-invasive monitor; novel; nursing intervention; pandemic disease; pressure; prototype; public health relevance; sensor; software development; standard of care; transmission process

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.

描述（由申请人提供）：美国大多数产科交付都经过连续的电子子宫活性监测。通常，采用外部造物量学计（应变计）来提供子宫收缩的频率和时机。在某些患者中，尤其是肥胖症患者，监测仪无法始终检测到收缩。在其他情况下，监视器需要经常由护理人员重新定位。唯一可用的替代方法是侵入性宫内压力导管（IUPC），其与感染的风险相关。在美国，产科套房受肥胖大流行的约束，这些妇女患有劳动问题，感染和其他并发症的风险增加。拟议的研究的具体目标是开发一个可靠的，非侵入性的子宫活性监测仪，该监测仪不受肥胖的影响，并且需要比TocodyNegemmeter更少的护理干预措施。最终产品将是一种“智能EHG电缆”，称为Etoco，它将子宫（电术或EHG）的电活动转换为与现有监测器兼容的子宫活性信号。 Etoco系统将插入现有监视器的TOCO或IUP端口，并提供更健壮和可靠的收缩曲线，而所需的护理干预措施较少并改善了患者舒适性。第一阶段的结果表明，EHG可以为此显示器提供一个简单的四电极阵列。电极阵列将是带有粘合剂背衬的单个网格，以便于放置。该项目提出了以下特定目的：目标1：构建生产等效的原型TOCO TOCO替换EHG硬件，软件和电极网格 - 将根据第I期中的最佳定位设计和原型设计电极网/阵列。此外，生产等效的硬件和嵌入式软件的eToco and eToco系统将设计和构建。为了支持FDA许可，产品设计期间将启动质量系统。 AIM 2：临床评估网格EHG子宫活动监测器 - 将收集所有数据，以FDA良好的临床实践（GCP）的标准收集，并且足以提供统计显着性。临床研究分为两个部分：第一个将评估130名患者的系统，而TOCO和IUP将评估第二部分在三个信号上对熟练的临床医生的解释，以确保相似性。 AIM 3：为TOCO替换系统提交FDA 510（k）的准备工作 - 本项目期间将实施所有必要的质量控制系统。此外，将准备510（k）提交。 AIM 4：对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替代超声FHR传感器。原型声传感器将作为一种新的方法测试，用于非侵入性监测胎儿心率。 公共卫生相关性：当前对子宫活动的非侵入性监测方法经常失败，尤其是在肥胖患者中。发生这种情况时，临床医生通常必须使用侵入性的子宫内压导管，这在这些患者中尤其有问题，因为它们已经处于感染风险增加。开发一种替代，廉价的传感器替代技术，该技术允许现有监测器非侵入性监测子宫活动，将改善诊断数据，减少所需的护理干预措施，并通过限制对侵入性监测的需求来减少感染并发症。