Leadless Pacemaker Fixation via Expandable Stent and Retrieval Mechanism

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Solution Overview

Problem

Existing leadless pacemakers face issues with ventricular fixation without atrial pacing, leading to atrioventricular desynchronization, low success rate of removal, and insufficient fixation firmness, resulting in dislodgement.

Innovation Solution

A cardiac pacing system with a ring-shaped stent and contractible member that allows fixation in the superior vena cava or SVC-RA junction for dual-chamber pacing, featuring a detachable connecting element and contractible elements for easy retrieval and re-positioning, along with fixation members for enhanced radial support.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a leadless pacemaker is fixed in the right ventricle, then ease of operation and minimal invasiveness are improved, but atrial pacing is lost leading to atrioventricular desynchronization

Engineering Contradiction:
Improveease of operationVSAvoidphysiological pacing
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The pacemaker is repositioned from the right ventricle to the superior vena cava, changing the spatial dimension of implantation. This allows the pacemaker to be positioned in a location that enables atrial pacing while maintaining the leadless implantation approach, thus resolving the contradiction between ease of operation and physiological pacing.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Ease of operation

If a leadless pacemaker is fixed in the right ventricle, then ease of operation is improved, but removal and retrieval success rate becomes low

Engineering Contradiction:
Improveease of operationVSAvoidremoval and retrieval
Core Design Contradiction:
Ease of operationVSEase of repair

Solution Approach 1:

A retrieval system with a retrieval member is introduced as an intermediary mechanism. The retrieval member can engage with the pacemaker through the delivery catheter, providing a controlled connection that enables easy removal and retrieval while maintaining the initial ease of implantation.

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If a leadless pacemaker is fixed in the right ventricle, then ease of operation is improved, but fixation firmness is insufficient leading to dislodgement

Engineering Contradiction:
Improveease of operationVSAvoidfixation firmness
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The fixation system incorporates a dynamic expandable stent that transitions from a compressed state during implantation to an expanded state for secure fixation. This dynamic transformation allows easy initial implantation followed by strong anchoring to prevent dislodgement, resolving the contradiction between ease of operation and fixation firmness.

Inventive Principle:
Principle #15Dynamics

Data Source

PatentUS12097375B2Cardiac pacing system and pacemaker fixing device
Publication Date: 2024.09.24 MICROPORT SORIN CRM (SHANGHAI) CO LTD
  • US12097375B2 patent drawing
  • US12097375B2 patent drawing
  • US12097375B2 patent drawing

AI summary

A cardiac pacing system and a pacemaker fixation device are disclosed. The pacemaker fixation device includes a ring-shaped stent and at least one contractible member. The ring-shaped stent is configured to load a leadless pacemaker and easily fix it at a target site in a patient's body reliably without dislodgement. A connecting element in the contractible member can be reliably connected to an external mechanism, thus facilitating retrieval and removal of the cardiac pacing system with an increased success rate. During implantation, the contractible member can be adapted by operating the external mechanism to adjust the pacing location for the leadless pacemaker, thus allowing the operator to easily determine the best pacing location that can result in enhanced pacing performance of the leadless pacemaker. Further, the leadless pacemaker may be fixed in the atrium in order to pace the atrium, thus reducing non-physiological pacing with atrioventricular desynchronization.