ECG Stability Analysis for Non-Invasive Sudden Cardiac Death Risk

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Solution Overview

Problem

Current methods for identifying individuals at risk for sudden cardiac death (SCD) lack sensitivity and specificity, particularly in low and intermediate risk groups, limiting the effectiveness of implantable cardioverter-defibrillators (ICDs) and posing a significant public health concern.

Innovation Solution

A non-invasive method using digitized electrocardiogram (ECG) data to construct linear and nonlinear mathematical models, analyzing the stability of ECG-derived control model systems to determine SCD risk with high sensitivity and specificity, utilizing techniques such as denoising, normalization, and system stability analysis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If current risk stratification methods are used to identify individuals at risk for SCD, then ICD placement can be performed, but the sensitivity and specificity are insufficient particularly in low and intermediate risk groups

Engineering Contradiction:

Improvesensitivity and specificity of SCD risk identificationVSAvoidaccuracy of risk stratification

Core Design Contradiction:

Measurement precisionVSReliability

Solution Approach 1:

The patent transforms the ECG signal from its original time-domain representation into the frequency domain using wavelet transform, enabling analysis of frequency components that are not visible in the raw signal. This parameter transformation allows detection of subtle arrhythmic patterns with high sensitivity and specificity, resolving the contradiction between measurement precision and reliability in SCD risk identification

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The patent replaces conventional mechanical/electrical risk assessment methods (such as simple ECG reading, exercise stress tests, or invasive electrophysiological studies) with a computational signal processing approach using wavelet analysis. This substitution enables non-invasive, automated detection of arrhythmic substrates with superior diagnostic accuracy, particularly in low and intermediate risk groups where current methods fail

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Productivity

If ICD therapy is provided to low and intermediate risk groups, then more patients receive treatment, but the overall incidence of SCD is not reduced because these patients do not benefit from prophylactic ICD placement

Engineering Contradiction:

Improvenumber of patients treatedVSAvoideffectiveness of SCD prevention

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The patent applies local quality analysis by examining specific frequency components and temporal patterns within the ECG signal that are locally characteristic of arrhythmic substrates. Rather than relying on global measures like left ventricular ejection fraction, the method identifies localized electrical abnormalities in the cardiac conduction system, enabling precise identification of patients who would genuinely benefit from ICD therapy

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The patent introduces wavelet analysis as an intermediary between the raw ECG signal and the clinical decision-making process. This intermediary transformation reveals hidden features in the ECG that serve as reliable markers for SCD risk, allowing clinicians to accurately distinguish between patients who need ICD implantation and those who would not benefit, thereby improving both the number of appropriately treated patients and the overall effectiveness of prevention

Inventive Principle:

Principle #24Intermediary (Mediator)

3Measurement precision

If comprehensive risk assessment methods are used to improve sensitivity and specificity, then the device complexity and cost increase

Engineering Contradiction:

Improvesensitivity and specificity of SCD risk predictionVSAvoidcomplexity of risk assessment system

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent extracts only the essential frequency components and temporal features from the ECG signal that are most predictive of SCD risk, using wavelet transform to isolate relevant information while discarding redundant data. This extraction approach achieves high sensitivity and specificity without requiring complex multi-modal assessment systems, thereby maintaining simplicity while improving measurement precision

Inventive Principle:

Principle #2Taking out (Extraction)

Data Source

PatentUS12575795B2Non-invasive prediction of risk for sudden cardiac death

Publication Date: 2026.03.17 SPANGLER SCIENTIFIC LLC

AI summary

A method and apparatus for the quantitative determination of an individual's risk for sudden cardiac death (SCD) is described. Risk determination is accomplished and may have a sensitivity and specificity of greater than 95%, by generating linear and nonlinear mathematical digital ECG-constructed models from digital ECG-type data of an individual's digital ECG, determining stability/instability of digital ECG-constructed control model systems corresponding to the digital ECG-constructed models by a plurality of techniques and transforming stability/instability values obtained by the determining stability/instability into a quantitative value reflecting an individual's risk for SCD.