Abdominal Surface Electrodes for Non-Invasive Fetal ECG Extraction
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Solution Overview
Problem
Current fetal monitoring systems during pregnancy are invasive, costly, and lack specificity, failing to provide reliable, continuous, and non-invasive assessment of fetal well-being and uterine activity, leading to increased morbidity and risk of postpartum hemorrhage.
Innovation Solution
A non-invasive maternal-fetal monitoring system using surface electrodes on the abdomen to extract maternal and fetal vital signs, including ECG, heart rate, and uterine activity, employing independent component analysis and neural networks for real-time data processing and interpretation, providing comprehensive health assessment and clinical advice.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Measurement precision
If invasive monitoring procedures (fetal scalp electrode, intra-uterine pressure catheter) are used to obtain accurate fetal and uterine data, then measurement precision and reliability are improved, but patient comfort and ease of operation deteriorate due to invasiveness and procedural risks
Solution Approach 1:
The patent uses an intermediary signal processing approach where abdominal surface electrodes capture mixed maternal-fetal signals, and independent component analysis (ICA) acts as a computational mediator to separate and extract pure fetal ECG and uterine activity signals from the composite abdominal recordings, eliminating the need for direct invasive contact with the fetus
Solution Approach 2:
The patent replaces the mechanical invasive insertion of electrodes and catheters into the uterus and fetal scalp with non-invasive abdominal surface electrode placement, using signal processing algorithms to substitute for the physical access previously required to obtain clean fetal signals
2Ease of operation
If non-invasive surface electrodes are used to monitor maternal and fetal signals, then ease of operation and patient comfort are improved, but measurement precision deteriorates due to signal contamination from maternal ECG and other abdominal signals
Solution Approach 1:
Independent component analysis (ICA) serves as a computational intermediary that processes the mixed abdominal signals containing maternal ECG, fetal ECG, and uterine activity, mathematically separating these overlapping signals to extract pure fetal and uterine components without requiring physical separation of the sources
Solution Approach 2:
The patent transforms the signal extraction problem from a spatial separation challenge to a parameter-space separation by applying ICA to decompose the composite signal into statistically independent components, changing the domain in which signal separation occurs from physical space to signal parameter space
3Reliability
If continuous electronic fetal monitoring is performed to detect fetal hypoxia early, then reliability of fetal well-being assessment is improved, but device complexity and cost increase
Solution Approach 1:
The patent makes the abdominal electrode system universal by enabling it to simultaneously perform multiple functions: recording maternal ECG, fetal ECG, and uterine electrical activity (EHG) through the same sensor array, with software algorithms separating and analyzing each signal type for comprehensive maternal-fetal monitoring
Solution Approach 2:
Signal processing algorithms act as intermediaries that transform the raw multi-component abdominal signals into clinically useful information about fetal heart rate, maternal cardiac status, and uterine contraction patterns, reducing system complexity by using computational methods rather than separate specialized sensors for each function
4Ease of operation
If tocodynamometry is used to detect uterine contractions, then ease of operation is improved, but measurement precision deteriorates in obese patients and when cervical dilation lags behind labor progress
Solution Approach 1:
The patent replaces the mechanical tocodynamometer that measures abdominal wall tension with an electrical field-based EHG system that directly detects uterine electrical activity and converts it to pressure measurements, substituting mechanical contact measurement with electrical field sensing to overcome obesity-related signal attenuation
Solution Approach 2:
The patent changes the measurement parameter from mechanical abdominal wall tension (tocodynamometry) to electrical potential differences generated by uterine muscle depolarization (EHG), transforming the physical quantity being measured to one that is less affected by maternal body composition and more directly related to actual uterine contraction strength
Data Source
AI summary
A maternal-fetal monitoring system for use during all stages of pregnancy, including antepartum and intrapartum stages. The maternal-fetal monitoring system of the subject invention comprises (1) a set of sensors; (2) an amplifying/filtering means; (3) a computing means; and (4) a graphical user interface. Accurate clinical data, which can be extracted and provided to the user in real-time using the system of the invention, include without limitation, maternal electrocardiogram (ECG) signals, maternal uterine activity signals (EHG), maternal heart rate, fetal ECG signals, and fetal heart rate. In a preferred embodiment, the maternal-fetal monitoring system of the invention includes an intelligence means, such as a neural network system, to analyze and interpret clinical data for use in clinical diagnosis antepartum, intrapartum and postpartum, as well as delivery strategy.