Leadless Pacing Device Mode Switching for Atrial Undersensing

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Solution Overview

Problem

Leadless pacing devices implanted in the ventricle face challenges in detecting atrial activation events due to low-power electrical activity, leading to atrial undersensing, which can result in inappropriate pacing modes and reduced synchrony with the atrial rhythm.

Innovation Solution

The leadless pacing device is configured to switch from atrio-ventricular synchronous pacing to asynchronous ventricular pacing based on detection of atrial or ventricular undersensing events, using a processing module to manage pacing modes and adjust timing of pacing pulses to maintain heart rhythm synchrony.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a leadless pacing device is implanted in the ventricle to deliver pacing pulses, then the device can provide cardiac pacing therapy, but the device has difficulty detecting atrial activation events due to low-power electrical activity

Engineering Contradiction:
Improvedetection of atrial activation eventsVSAvoidpower of electrical activity
Core Design Contradiction:
Measurement precisionVSUse of energy by moving object

Solution Approach 1:

The patent introduces an intermediary mechanism by using the ventricular leadless device to sense both atrial and ventricular events. The device acts as a mediator between the heart's electrical activity and the pacing function, using the same sensing electrodes to detect both atrial activation (P-waves) and ventricular depolarization (R-waves), thereby resolving the contradiction between detecting low-power atrial signals and providing effective pacing therapy.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Reliability

If the device operates in sensing without pacing mode, then it can monitor heart activity, but it cannot provide pacing therapy when undersensing occurs

Engineering Contradiction:
Improvedetection accuracyVSAvoidpacing mode flexibility
Core Design Contradiction:
ReliabilityVSAdaptability or versatility

Solution Approach 1:

The patent implements dynamic mode switching capability that allows the device to transition between sensing without pacing mode and atrio-ventricular synchronous pacing mode based on detection accuracy. When undersensing is detected, the device dynamically adjusts its operational mode to maintain reliable heart rhythm management, thereby resolving the contradiction between detection reliability and pacing versatility.

Inventive Principle:
Principle #15Dynamics

Solution Approach 2:

The patent changes the operational parameters of the device by switching between different pacing modes. When atrial undersensing is detected, the device changes from attempting to synchronize with atrial activity to operating in a mode that ensures reliable ventricular pacing, thereby adapting to the detected signal quality and maintaining therapeutic effectiveness.

Inventive Principle:
Principle #35Parameter changes

3Reliability

If the device switches to asynchronous ventricular pacing to avoid atrial undersensing, then it can provide reliable pacing therapy, but it loses synchrony with atrial rhythm

Engineering Contradiction:
Improvepacing therapy deliveryVSAvoidatrio-ventricular synchrony
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent dynamically changes the pacing mode parameters based on detected signal quality. When atrial undersensing is detected, the device transitions from atrio-ventricular synchronous pacing (which maintains synchrony) to asynchronous ventricular pacing (which ensures reliable therapy delivery). This parameter change resolves the contradiction by adapting the pacing strategy to the actual sensing capabilities.

Inventive Principle:
Principle #35Parameter changes

Data Source

PatentEP3218051B1Mode switching by a ventricular leadless pacing device
Publication Date: 2023.01.25 MEDTRONIC INC
  • EP3218051B1 patent drawingFigure 1
  • EP3218051B1 patent drawingFigure 2
  • EP3218051B1 patent drawingFigure 3A

AI summary

In some examples, a leadless pacing device (hereinafter, "LPD") is configured for implantation in a ventricle of a heart of a patient, and is configured to switch between an atrio-ventricular synchronous pacing mode and an asynchronous ventricular pacing mode in response to detection of one or more sensing events, which may be, for example, undersensing events. In some examples, an LPD is configured to switch from a sensing without pacing mode to an atrio-ventricular synchronous pacing mode in response to determining, for a threshold number of cardiac cycles, a ventricular depolarization was not detected within a ventricular event detection window that begins at an atrial activation event.