HRV Analysis Predicting VNS Efficacy

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Solution Overview

Problem

Current methods for predicting the efficacy of vagus nerve stimulation (VNS) treatment for medically intractable epilepsy are unclear and costly, with inconsistent results due to high costs and complexity of EEG and MRI methods, and lack of effective predictive tools.

Innovation Solution

A low-cost, portable method using heart rate variability (HRV) analysis from 24-hour ECG recordings to calculate time, frequency, and nonlinear domain parameters, characterizing vagus nerve activity to predict treatment efficacy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If EEG and MRI methods are used to predict VNS treatment efficacy, then measurement precision is improved, but device complexity and cost increase

Engineering Contradiction:

Improveprediction accuracyVSAvoidcomplexity of operation

Core Design Contradiction:

Measurement precisionVSDevice complexity

Solution Approach 1:

The patent replaces expensive, complex EEG and MRI equipment with a simple, low-cost portable ECG recorder that can be easily deployed and disposed of or reused. This disposable/low-cost approach maintains adequate measurement precision for clinical decision-making while dramatically reducing device complexity and operational burden

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent substitutes complex mechanical and electronic systems (EEG electrodes, MRI magnets) with a simplified ECG-based HRV analysis system. By measuring heart rate variability through standard ECG leads and analyzing temporal patterns computationally, the system achieves predictive capability without requiring complex imaging or electroencephalographic equipment

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Measurement precision

If EEG and MRI methods are used to predict VNS treatment efficacy, then measurement precision is improved, but cost increases

Engineering Contradiction:

Improveprediction accuracyVSAvoidcost

Core Design Contradiction:

Measurement precisionVSLoss of energy

Solution Approach 1:

The patent employs low-cost portable ECG recorders instead of expensive EEG and MRI equipment. These simple devices can be obtained at minimal cost and provide sufficient data quality for HRV analysis, thereby dramatically reducing the financial burden on healthcare systems and patients while maintaining clinically useful prediction accuracy

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

The patent creates a functional copy of the neural activity information through cardiovascular manifestations. Instead of directly measuring brain electrical activity (EEG) or structural imaging (MRI), the system captures equivalent predictive information through heart rate variability patterns, which are physiological reflections of autonomic nervous system function and thus provide a cost-effective proxy measurement

Inventive Principle:

Principle #26Copying

3Reliability

If comprehensive preoperative evaluation including MRI and EEG is performed, then reliability of prediction is improved, but loss of time increases

Engineering Contradiction:

Improveprediction reliabilityVSAvoidtime for evaluation

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The patent extracts the essential predictive information from the comprehensive evaluation protocol by isolating and analyzing only the heart rate variability component from ECG data. This extraction approach removes unnecessary time-consuming procedures (extensive MRI sequences, prolonged EEG monitoring) while retaining the critical autonomic function assessment needed for reliable VNS efficacy prediction

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The patent performs preliminary HRV analysis using simple ECG recordings obtained during routine clinical visits or brief monitoring periods. By conducting this assessment early in the evaluation process before committing patients to lengthy MRI and EEG protocols, the system quickly identifies suitable candidates for VNS treatment, thereby reducing overall evaluation time while maintaining prediction reliability

Inventive Principle:

Principle #10Preliminary action

Data Source

PatentUS11793449B2Heart rate variability analysis method, device and use thereof

Publication Date: 2023.10.24 BEIJING PINS MEDICAL

AI summary

A method and an apparatus for analyzing heart rate Variability (HRV), and use thereof are provided. A low-cost, portable and wearable signal acquisition device is utilized to acquire electrocardiography (ECG) signals of epilepsy patients for 24 hours before treatment, and a time domain index, a frequency domain index and a nonlinear index of the ECG during a long term and during a short term are calculated with a programmed HRV analysis method, and the efficacy of vagus nerve stimulation (VNS) treatment for patients with medically intractable epilepsy is accurately and efficiently predicted based on characteristic parameters for characterizing an effect level of the vagus nerve regulating the heart rate, i.e., vagus nerve activity, thereby avoiding unnecessary costs and avoiding the delay of the optimal treatment timing. In addition, the characteristic parameters obtained by the HRV analysis on the ECG may be utilized to clearly select VNS treatment indication patients.