Leadless Pacemaker AV Synchrony via Ventricular Parameter Inversion

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Solution Overview

Problem

Implantable leadless pacemakers face challenges in maintaining atrioventricular (AV) synchrony without a lead in the atrial chamber, as direct measures of atrial contraction from the ventricle often result in small, inconsistent, or non-existent signal components, and additional sensing extensions are not desirable.

Innovation Solution

An implantable pacemaker that generates electrical pacing pulses and senses ventricular events, using a sensor to measure physiological signals like heart sounds or pressure to determine AV delay parameters, and adjusts pacing timing based on a reference curve to achieve AV synchrony without relying on atrial signals.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If direct measures of atrial contraction are attempted from the ventricle, then AV synchrony can be maintained, but the signal components become small, inconsistent, or non-existent

Engineering Contradiction:
ImproveAV synchrony maintenanceVSAvoidatrial signal detection
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

Instead of measuring atrial contraction directly from the ventricle (which yields small, unreliable signals), the patent inverts the approach by measuring ventricular contraction parameters and using these to indirectly determine AV synchrony status. The pacemaker measures ventricular contraction parameters and compares them against reference curves to infer whether AV synchrony is maintained, thereby avoiding the need for direct atrial signal detection from the ventricle.

Inventive Principle:
Principle #13The other way round (Inversion)

Solution Approach 2:

The patent introduces ventricular contraction parameters as an intermediary measure to indirectly assess AV synchrony. Rather than directly detecting atrial signals, the system uses ventricular parameters (such as contraction timing or mechanical characteristics) as a mediator that reflects the state of AV synchrony, making the measurement reliable and consistent.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If an atrial sensing extension is added to the pacemaker, then AV synchrony can be achieved, but the device complexity increases

Engineering Contradiction:
ImproveAV synchronyVSAvoidsensing extension
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent extracts the AV synchrony assessment function from the atrial chamber sensing extension and relocates it to the ventricular measurement system. By using ventricular contraction parameters measured within the existing pacemaker structure, the system eliminates the need for additional atrial sensing extensions while maintaining AV synchrony capability.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent makes the existing ventricular sensing capabilities serve multiple functions: they not only detect ventricular contraction for basic pacing but also indirectly assess AV synchrony status through parameter comparison against reference curves. This multi-functionality eliminates the need for separate atrial sensing hardware.

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

3Device complexity

If traditional VVI mode pacing is used, then the pacemaker structure remains simple, but AV dyssynchrony occurs resulting in suboptimal cardiovascular output

Engineering Contradiction:
Improvepacemaker structureVSAvoidcardiovascular output
Core Design Contradiction:
Device complexityVSProductivity

Solution Approach 1:

The patent implements feedback by continuously measuring ventricular contraction parameters and comparing them against reference curves that represent optimal AV synchrony. Based on this comparison, the pacemaker adjusts pacing timing to maintain optimal cardiovascular output, creating a closed-loop system that improves productivity while keeping the structure relatively simple.

Inventive Principle:
Principle #23Feedback

Data Source

PatentEP3718598B1AV synchrony with a ventricular leadless pacemaker using varying ventricular measures
Publication Date: 2024.07.31 BIOTRONIK SE & CO KG
  • EP3718598B1 patent drawingFigure 1
  • EP3718598B1 patent drawingFigure 2
  • EP3718598B1 patent drawingFigure 3

AI summary

The present disclosure relates to an implantable pacemaker (1) configured to provide electrical pacing pulses to the heart (2) of a patient. The pacemaker (1) comprises a pulse generator (3) configured to generate said electrical pacing pulses, at least one pacing electrode (4) to apply said electrical pacing pulses to the heart (2), a sensing unit (5) configured to sense events of electrical activity of a ventricle (2a) of the heart (2), a sensor (6) configured to measure a signal relating to the patient, and a memory (7) configured to store values of a parameter (P). The pacemaker (1) is configured to be operated in a first mode to generate a reference curve (R) and to select a target range (T) of values of the parameter (P) corresponding to a desired range (D) of atrioventricular delays. The pacemaker (1) is further configured to be operated in a second mode for approaching the target range.