ECG-Based Fluid Responsiveness Prediction System

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Solution Overview

Problem

Current methods for predicting fluid responsiveness in hemodynamically unstable patients are invasive, not sufficiently accurate, and rely on single parameters, failing to account for the interplay of various physiological variables, which complicates optimal fluid administration and cardiac output management.

Innovation Solution

The use of continuous, higher resolution electrocardiogram (ECG) signals, processed by a computer system with a mathematical algorithm, to non-invasively predict fluid responsiveness by analyzing changes in ECG parameters influenced by multiple physiological variables, providing a comprehensive and accurate assessment.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If invasive methods (such as arterial line measurement, stroke volume variation monitoring) are used to predict fluid responsiveness, then measurement precision is improved, but device complexity and ease of operation deteriorate

Engineering Contradiction:
Improvefluid responsiveness prediction accuracyVSAvoidmonitoring system complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces invasive mechanical monitoring systems (arterial lines, stroke volume variation monitors) with a non-invasive ECG-based electrical signal analysis system. The method uses standard ECG leads to detect electrical cardiac signals and processes them through algorithms that analyze heart rate variability and electrical characteristics to predict fluid responsiveness without requiring invasive catheters or complex mechanical sensors.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent extracts the essential predictive information from the ECG signal itself, separating the prediction function from the invasive monitoring infrastructure. By isolating the key electrical cardiac parameters (heart rate, RR interval variability, electrical axis) from the ECG waveform, the system achieves fluid responsiveness prediction using only standard ECG equipment already present in most clinical settings, eliminating the need for additional invasive devices.

Inventive Principle:
Principle #2Taking out (Extraction)

2Device complexity

If single parameter methods (such as pulse pressure variation, stroke volume variation) are used to predict fluid responsiveness, then device complexity is reduced, but measurement precision deteriorates due to inability to account for interplay of physiological variables

Engineering Contradiction:
Improvemonitoring method simplicityVSAvoidfluid responsiveness prediction accuracy
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The patent merges multiple ECG-derived parameters into a unified analysis framework that simultaneously evaluates heart rate, RR interval variability, electrical axis orientation, and waveform characteristics. This integrated approach allows the system to capture the interplay between different physiological variables (autonomic nervous system activity, respiratory variations, cardiac mechanics) that individually cannot predict fluid responsiveness accurately, thereby improving precision while maintaining relative simplicity.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The patent creates a universal ECG-based prediction system that serves multiple functions: it analyzes electrical cardiac activity, detects respiratory variations, evaluates autonomic tone, and predicts fluid responsiveness. By making the ECG signal multi-functional for these diverse assessment purposes, the system achieves high measurement precision without requiring separate specialized monitors for each parameter, thus maintaining operational simplicity.

Inventive Principle:
Principle #6Universality (Multi-functionality)

3Reliability

If continuous monitoring of fluid responsiveness is implemented, then reliability is improved, but use of energy and loss of time increase

Engineering Contradiction:
Improvecontinuous fluid responsiveness assessmentVSAvoidmonitoring system energy consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The patent enables the ECG signal to serve dual purposes: its primary function for diagnosing cardiac arrhythmias and its secondary function for predicting fluid responsiveness. By leveraging the existing ECG signal already being recorded for cardiac monitoring, the system achieves continuous fluid responsiveness assessment without requiring separate dedicated energy-intensive sensors or continuous additional data acquisition systems, thus improving reliability while minimizing extra energy consumption.

Inventive Principle:
Principle #25Self-service

Data Source

PatentUS11284836B2Methods and systems for improved prediction of fluid responsiveness
Publication Date: 2022.03.29 CN MEDICAL RESEARCH LLC
  • US11284836B2 patent drawing
  • US11284836B2 patent drawing

AI summary

The present disclosure provides systems and methods for predicting fluid responsiveness. Embodiments include sensors configured to obtain a high-resolution electrocardiogram signal and a computer system connected to the sensors, the computer system including a memory, a processor, and a display device. Computer system may be configured to receive the electrocardiogram signal from the sensors. Processor may be configured to detect and process changes in at least one of length, amplitude, slope, area, depth, and height of at least one of P, Q, R, S, T, and U complex of the electrocardiogram signal caused by the influence of physiological variables on each other to create a prognostic index. Processor may be further configured to analyze, quantify, and combine the prognostic index of the changes in the electrocardiogram signal and generate a fluid responsiveness prediction. Display device may display the results of the fluid responsiveness prediction.