Novel fetal heart monitor technology

新型胎心监护技术

• 批准号: 6885247
• 负责人: WAYNE I STERNBERGER
• 金额: $ 10万
• 依托单位: BIOCONNEXIONS, LLC
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-02-01 至 2005-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6885247
• 关键词: biomedical automation; biomedical equipment development; clinical research; computer assisted diagnosis; data collection; electrocardiography; embryo /fetus monitoring; heart function; patient monitoring device

DESCRIPTION (provided by applicant): Significant progress has been made in the science of electrocardiography since 1938. Heart rate and biophysical profiles are routinely derived from multi-lead electrocardiograms (ECGs) in animals and humans after birth. In contrast, only limited heart monitoring technologies exist for the fetus. Moreover, available technology fails to satisfy many existing needs in fetal ECG monitoring, both to support fundamental research on fetal development, and for clinical assessment of fetal health. This grant application proposes to reduce the technology gap that persists in fetal ECG monitoring in order to support advanced assessments of fetal health and development. The goal of this technology is to 1) monitor the fetal condition in an objective, quantitative, and non-invasive manner by enabling continuous and highly specific data collection during pre-natal development and the intra-partum period, 2) aid in the fetal and maternal treatment planning regimen potentially earlier than presently feasible, thus facilitating or indicating interventions which may reduce maternal and fetal morbidity and mortality, 3) maximize the health and well-being of the mother and fetus by reducing unnecessary or ineffective interventions (e. g., unnecessary C-sections) and the number of babies born with effects of such interventions, and 4) support fetal development research. Specific aims are directed to the refinement and validation of the technology for the purpose of prototyping a device that is fully automated, requires no user intervention, and produces a relevant quantitative output in real time. The specific aims of this Phase 1 effort include: 1) automating and optimizing the existing signal processing parameter controls by eliminating current requirement for certain operator decisions ("man-in-the-loop") during processing, and 2) designing a robust and clinically acceptable data collection interface to the patient by optimizing the data collection hardware configuration. This research will serve to further the experimental technology advanced in the existing research by providing the capability to collect transabdominal fetal ECG data without multiple, individually applied electrodes, making such monitoring valuable as a commercial application and more accessible to the research community. In addition, the proposed instrumentation will overcome existing limitations in accuracy resulting from data averaging to extract the maternal ECG. In this regard, the development of the new fetal heart rate technology not only has significant commercial potential, but offers the research community new tools to assess fetal health and fetal development.

描述（由申请人提供）：自1938年以来，心电图科学已经取得了重大进展。心率和生物物理特征通常源自生物和人类后的动物和人类的多铅心电图（ECG）。相反，胎儿只有有限的心脏监测技术。此外，可用的技术无法满足胎儿心电图监测中的许多现有需求，既支持胎儿发育的基本研究，又用于胎儿健康的临床评估。该赠款申请建议减少胎儿心电图监测中持续存在的技术差距，以支持对胎儿健康和发育的高级评估。该技术的目的是1）通过在产前发育期间和伴侣内启用连续且高度特定的数据收集，以客观，定量和非侵入性方式监测胎儿状况，2）以及孕产妇的治疗计划可能早于目前可行的，因此可以促进或表明可能会降低孕产妇和胎儿的发病率和死亡率的干预措施，3）最大化母亲和胎儿的健康和福祉（通过减少不必要或无效的干预措施）剖腹产）以及出生的婴儿的数量，以及4）支持胎儿发育研究。具体目标是针对技术的完善和验证，目的是制定完全自动化的设备，不需要用户干预，并实时产生相关的定量输出。该阶段1的特定目的包括：1）通过消除处理过程中某些操作员的当前要求（“人工”）的当前要求，并在处理过程中自动化和优化现有的信号处理参数控件，以及2）设计强大的和强大的和通过优化数据收集硬件配置，向患者临床上可接受的数据收集接口。这项研究将通过提供跨腹胎胎心电图数据的能力，而无需多个单独应用的电极，从而使现有研究的实验技术进一步提高了现有研究的实验技术，从而使研究社区更有价值的监控。此外，提出的仪器将克服数据平均以提取母体心电图的数据导致的准确性局限性。在这方面，新的胎儿心率技术的发展不仅具有巨大的商业潜力，而且为研究社区提供了评估胎儿健康和胎儿发育的新工具。