Implantable Device False Arrhythmia Detection via R-R Interval Analysis

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Solution Overview

Problem

Existing implantable medical devices (IMDs) face challenges in accurately detecting arrhythmias due to false positive detections caused by R-wave undersensing and intermittent atrioventricular (AV) conduction block, leading to inappropriate therapy and increased clinical workload.

Innovation Solution

The method involves obtaining information for at least three R-R intervals and classifying one as false based on its duration being greater than a specified threshold and within a threshold of being an integer multiple of neighboring R-R intervals, thereby identifying false R-R intervals and arrhythmia detections associated with R-wave undersensing or AV conduction block.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If the R-wave sensing threshold is kept at its nominal value, then the device complexity is reduced and ease of operation is improved, but measurement precision deteriorates due to R-wave undersensing when R-wave amplitude is too small

Engineering Contradiction:
ImproveR-wave detection accuracyVSAvoidthreshold adjustment complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The system automatically adjusts the R-wave sensing threshold based on detected R-wave amplitudes without requiring manual clinician intervention. The processor continuously monitors R-wave characteristics and autonomously modifies the threshold to optimize detection accuracy while maintaining operational simplicity.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The R-wave sensing threshold parameter is dynamically changed based on real-time R-wave amplitude measurements. When R-wave amplitudes are detected to be below a predetermined level, the system automatically lowers the sensing threshold to compensate and maintain accurate R-wave detection.

Inventive Principle:
Principle #35Parameter changes

2Measurement precision

If the R-wave sensing threshold is lowered to correct R-wave undersensing, then measurement precision of R-wave detection is improved, but false positive arrhythmia detections increase due to P-wave and T-wave oversensing

Engineering Contradiction:
ImproveR-wave detection accuracyVSAvoidfalse positive arrhythmia detections
Core Design Contradiction:
Measurement precisionVSObject-generated harmful factors

Solution Approach 1:

The system employs feedback mechanisms where detected P-waves and T-waves are fed back to the processor, which then adjusts the R-wave sensing threshold accordingly. This prevents over-adjustment that would cause P-wave and T-wave oversensing while maintaining R-wave detection accuracy.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The sensing threshold is made dynamic rather than static, continuously adapting to the patient's cardiac signal characteristics. The threshold automatically adjusts in response to changing R-wave and P-wave amplitudes, balancing detection sensitivity with specificity to minimize false positives.

Inventive Principle:
Principle #15Dynamics

3Measurement precision

If clinicians manually adjust the R-wave sensing threshold, then R-wave detection accuracy is improved, but ease of operation deteriorates due to increased clinical workload

Engineering Contradiction:
ImproveR-wave detection accuracyVSAvoidclinical workload
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The system performs self-adjustment of the R-wave sensing threshold using automated algorithms that analyze R-wave and P-wave characteristics. This eliminates the need for manual clinician intervention, significantly reducing clinical workload while maintaining detection accuracy.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

Manual mechanical adjustment by clinicians is replaced with an automated electronic adjustment system. The processor uses computational algorithms to analyze cardiac signals and automatically modify the sensing threshold, substituting human expertise with automated intelligence.

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

4Reliability

If intermittent AV conduction block is present, then the heart rate variability is increased, but measurement precision of arrhythmia detection deteriorates due to false positive AF detections

Engineering Contradiction:
Improvearrhythmia detection reliabilityVSAvoidarrhythmia detection accuracy
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The system uses feedback from R-R interval analysis to detect patterns consistent with AV conduction block. When such patterns are identified, the system adjusts its arrhythmia detection algorithms to account for these physiological variations, reducing false positive AF detections.

Inventive Principle:
Principle #23Feedback

Solution Approach 2:

The system performs preliminary analysis of R-R intervals to identify signs of AV conduction block before making arrhythmia diagnoses. This preliminary detection allows the system to modify its detection criteria in advance, preventing misinterpretation of conduction block-related variability as arrhythmia.

Inventive Principle:
Principle #10Preliminary action

Data Source

PatentUS20250032032A1Identifying false r-r intervals and false arrhythmia detections due to r-wave undersensing or intermittent AV conduction block
Publication Date: 2025.01.30 PACESETTER INC
  • US20250032032A1 patent drawing
  • US20250032032A1 patent drawing
  • US20250032032A1 patent drawing

AI summary

Described herein are methods, devices, and systems for identifying false R-R intervals, and false arrhythmia detections, resulting from R-wave undersensing or intermittent AV conduction block. Each of one or more of the R-R intervals is classified as being a false R-R interval in response to a duration the R-R interval being greater than a first specific threshold, and the duration the R-R interval being within a second specified threshold of being an integer multiple of at least X other R-R intervals for which information is obtained, wherein the integer multiple is at least 2, and wherein X is a specified integer that is 1 or greater. When performed for R-R intervals in a window leading up to a detection of a potential arrhythmic episode, results of the classifying can be used to determine whether the potential arrhythmic episode was a false positive detection.