Extravascular Cardiac Defibrillator Morphology Discrimination

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Solution Overview

Problem

Implantable cardioverter defibrillators (ICDs) face challenges in accurately discriminating between different arrhythmias and efficiently delivering therapies, leading to potential unnecessary battery drain and patient discomfort due to excessive shock therapies.

Innovation Solution

The development of an extravascular cardiac defibrillation system that uses a subcutaneous ICD with advanced signal processing and morphology analysis to differentiate between ventricular tachycardia and fibrillation, optimizing therapy delivery and minimizing unnecessary shocks by employing a combination of interval-based detection and morphology processing.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If ICD delivers therapy for every detected tachycardia event, then the reliability of arrhythmia treatment is improved, but the battery charge is excessively consumed and patient exposure to painful shocks increases

Engineering Contradiction:
Improvearrhythmia treatment reliabilityVSAvoidbattery charge consumption
Core Design Contradiction:
ReliabilityVSUse of energy by moving object

Solution Approach 1:

The system uses morphology feedback by comparing the shape and characteristics of detected tachycardia waves against stored templates to determine whether therapy is truly necessary. This feedback mechanism allows the device to distinguish between genuine arrhythmias requiring treatment and false positives, thereby reducing unnecessary battery consumption while maintaining treatment reliability for actual arrhythmia events.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system changes the detection parameter from simple rate-based detection to morphology-based detection. By analyzing the shape, amplitude, and other characteristics of the cardiac waves rather than just the heart rate, the device can more accurately identify true arrhythmias and avoid unnecessary therapies, thus conserving battery charge while maintaining treatment effectiveness.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If ICD delivers therapy for every detected tachycardia event, then the reliability of arrhythmia treatment is improved, but patient exposure to painful shock therapies increases

Engineering Contradiction:
Improvearrhythmia treatment reliabilityVSAvoidpatient exposure to painful shocks
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The morphology comparison system provides feedback to verify whether detected tachycardia events truly match the characteristics of dangerous arrhythmias. By comparing wave shapes and characteristics against stored templates, the system can confidently withhold therapy from non-matching events, reducing patient exposure to painful unnecessary shocks while maintaining reliable treatment for genuine arrhythmias.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system uses stored morphology templates as reference patterns that can be quickly compared against incoming signals. These templates act as disposable reference points that enable rapid discrimination without requiring complex real-time analysis, allowing the device to quickly determine whether therapy is needed and avoid unnecessary patient exposure to painful shocks.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Device complexity

If simple rate-based detection is used, then the device complexity is reduced, but the measurement precision of arrhythmia detection deteriorates

Engineering Contradiction:
Improvedetection algorithm complexityVSAvoidarrhythmia detection precision
Core Design Contradiction:
Device complexityVSMeasurement precision

Solution Approach 1:

The system replaces simple rate-based mechanical detection with morphology-based signal analysis. Instead of merely counting heart rate intervals, the device analyzes the shape and characteristics of cardiac waves, substituting a more sophisticated detection mechanism that provides superior measurement precision while managing complexity through efficient signal processing algorithms.

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

Solution Approach 2:

The detection system changes from monitoring a single parameter (heart rate interval) to analyzing multiple parameters including wave shape, amplitude, and morphology characteristics. This multi-parameter approach significantly improves measurement precision for arrhythmia detection while the system manages complexity by focusing on key discriminatory features rather than attempting to analyze all possible signal characteristics.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3131626B1Apparatus for verifying discriminating of tachycardia events in a medical device having dual sensing vectors
Publication Date: 2020.05.06 MEDTRONIC INC
  • EP3131626B1 patent drawingFigure 1
  • EP3131626B1 patent drawingFigure 2
  • EP3131626B1 patent drawingFigure 3

AI summary

A method and medical device for detecting a cardiac event that includes sensing cardiac signals from a plurality of electrodes forming a first sensing vector sensing a first interval and a second sensing vector sensing a second interval, determining, for each of the first interval and the second interval, whether each beat of the plurality of beats is one of a match beat and a non-match beat, determining whether each beat of the plurality of beats is one of a high confidence beat and a low confidence beat, determining, for each of the first interval and the second interval, the number of beats determined to be both a non-match beat and a high confidence beat being greater than a threshold, and determining whether to deliver therapy in response to identifying of each of the first interval and the second interval as being one of shockable and not shockable.