Leadless Cardiac Pacing Device Helical Fixation and Retrieval

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Solution Overview

Problem

Conventional pacemakers require electrical leads that extend from a pulse generator to heart tissue, which can be cumbersome and less effective for certain cardiac arrhythmias, whereas leadless cardiac pacing devices are self-contained and fixed within the heart, but require efficient delivery and retrieval methods.

Innovation Solution

A leadless cardiac pacing device with a helical fixation member and a system for implantation and retrieval, including a proximal hub and elongate shaft, allowing for secure anchoring and removal from cardiac tissue using a transverse member and rotational mechanisms.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional pacemakers with electrical leads are used, then electrical stimulation can be provided to heart tissue, but the device becomes cumbersome and less effective for certain cardiac arrhythmias

Engineering Contradiction:
Improveeffectiveness for cardiac arrhythmiasVSAvoidcumbersomeness of electrical leads
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent divides the conventional pacemaker system into separate components: a leadless pacing device (microgenerator) that is implanted directly in the heart chamber, and an external programmer for device control. This segmentation eliminates the need for electrical leads connecting a pulse generator to the heart, thereby reducing device complexity while maintaining or improving effectiveness for treating cardiac arrhythmias

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent extracts the pulse generator function from the lead system and places it directly into the heart chamber as a self-contained microgenerator. This extraction removes the cumbersome electrical leads from the system while preserving the essential electrical stimulation function, thus improving reliability by eliminating potential failure points in the lead connections

Inventive Principle:
Principle #2Taking out (Extraction)

2Device complexity

If leadless cardiac pacing devices are used, then device complexity is reduced, but delivery and retrieval methods become challenging

Engineering Contradiction:
Improveself-contained device structureVSAvoiddelivery and retrieval efficiency
Core Design Contradiction:
Device complexityVSEase of operation

Solution Approach 1:

The patent employs a nested delivery system where the leadless pacing device is contained within a delivery catheter, which is in turn contained within an even larger delivery system. The device is nested within the catheter lumen during delivery, allowing minimally invasive insertion through blood vessels. For retrieval, the entire assembly can be withdrawn through the same access point, making the procedure easier and safer

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The patent introduces a delivery catheter as an intermediary device that facilitates the insertion and retrieval of the leadless pacing device. The catheter serves as a mediator that guides the device to the target heart chamber and provides a pathway for removal if needed, thereby improving ease of operation without compromising the self-contained nature of the pacing device

Inventive Principle:
Principle #24Intermediary (Mediator)

3Stability of the object's composition

If helical fixation member is used for anchoring, then device stability in cardiac tissue is improved, but risk of tissue damage during retrieval increases

Engineering Contradiction:
Improveanchoring stabilityVSAvoidtissue damage risk
Core Design Contradiction:
Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent designs the helical fixation member to be dynamic rather than permanently fixed. The helix can be rotated and advanced to engage with cardiac tissue for stable anchoring during device operation. For retrieval, the helix can be rotated in the opposite direction to disengage from the tissue, allowing removal without causing damage. This dynamic capability resolves the contradiction between stable anchoring and safe retrieval

Inventive Principle:
Principle #15Dynamics

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

Enables efficient delivery and anchoring of the leadless cardiac pacing device within the heart, facilitating effective electrical stimulation and sensing, while allowing for safe retrieval without causing tissue damage.

Implementation Method 1

a helical fixation member opposite the proximal hub

Methodology Applied
Scientific EffectHelical engagement: Screw

Implementation Method 2

The proximal hub includes a transverse channel extending into the proximal hub, the transverse channel being configured to engage the transverse member

Methodology Applied
Scientific EffectMechanical engagement: Mechanical Fastener

Data Source

PatentEP4028117B1Systems for implanting and/or retrieving a leadless cardiac pacing device with helix fixation
Publication Date: 2024.04.24 CARDIAC PACEMAKERS INC
  • EP4028117B1 patent drawingFigure 1
  • EP4028117B1 patent drawingFigure 2
  • EP4028117B1 patent drawingFigure 3

AI summary

A system may include a leadless cardiac pacing device including a body, a proximal hub, and a helical fixation member opposite the proximal hub; and a first elongate shaft having a lumen extending from a distal end of the elongate shaft proximally into the elongate shaft and a transverse member extending transversely across the lumen. The proximal hub may include a transverse channel extending into the proximal hub, the transverse channel being configured to engage the transverse member.