Biostimulator Transport System With Flexible Extended Electrode

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Solution Overview

Problem

Existing leadless pacemakers are not suitable for left bundle branch (LBB) pacing due to their long and rigid design, which can interfere with heart structures and function.

Innovation Solution

A biostimulator transport system that includes a flexible extended electrode and a biostimulator housing located near the apex of the right ventricle, allowing for safe and non-obstructive pacing at the LBB without interfering with adjacent heart structures.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing leadless pacemakers with long and rigid bodies are used for LBB pacing, then pacing function can be achieved, but they interfere with heart structures and may become tangled within chordae tendinae

Engineering Contradiction:
Improvepacing functionVSAvoidinterference with heart structures
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The biostimulator is divided into two main segments: a housing portion and a flexible extension portion. The housing contains the electronic circuitry and battery, while the flexible extension carries the pacing electrode. This segmentation allows the rigid housing to be positioned safely in the right ventricle apex while the flexible extension reaches the septal wall for pacing, preventing interference with chordae tendinae and other heart structures.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The flexible extension portion is designed as a thin, flexible structure that can bend and conform to the heart's internal geometry. This flexibility allows the extension to navigate around heart structures without becoming tangled in chordae tendinae, while still delivering effective pacing to the left bundle branch through the septal wall.

Inventive Principle:
Principle #30Flexible shells and thin films

2Reliability

If existing leadless pacemakers are positioned at the interventricular septal wall, then LBB pacing can be achieved, but the proximal end may flail within the heart chamber causing cyclical contact with adjacent structures

Engineering Contradiction:
ImproveLBB pacingVSAvoidcyclical contact with adjacent heart structures
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

By separating the housing and the pacing electrode through a flexible extension, the housing can be anchored in the right ventricle apex where it remains stable and does not flail. The flexible extension independently positions the pacing electrode at the septal wall, eliminating the flailing motion that would otherwise occur with a single rigid body design.

Inventive Principle:
Principle #1Segmentation

3Object-affected harmful factors

If a flexible extension electrode is used to reach the septal wall from the right ventricle apex, then interference with adjacent structures is reduced, but the device complexity increases

Engineering Contradiction:
Improveinterference with adjacent structuresVSAvoiddevice structure
Core Design Contradiction:
Object-affected harmful factorsVSDevice complexity

Solution Approach 1:

The flexible extension integrates multiple functions into a single component: it provides structural support to bridge the gap between housing and electrode, enables flexible positioning to avoid heart structures, and serves as the conduit for electrical signals. This merging reduces overall device complexity compared to having separate components for each function.

Inventive Principle:
Principle #5Merging (Combining)

Data Source

PatentEP4324510B1Biostimulator transport system having drive belt
Publication Date: 2025.03.05 PACESETTER INC
  • EP4324510B1 patent drawingFigure 1
  • EP4324510B1 patent drawingFigure 2
  • EP4324510B1 patent drawingFigure 3

AI summary

A biostimulator transport system (202) for transporting a biostimulator (100) includes a sleeve (208) having a sleeve lumen (302). A support member (206) extends through the sleeve lumen (302), and a belt (308) extends longitudinally through the sleeve lumen (302) between the sleeve (208) and the support member (206). The belt (308) has a loop (312) distal to a distal member end (306) of the support member (206). A portion of a biostimulator (100) can extend through the loop (312) such that the belt (308) retains the biostimulator (100) against the support member (206).