Segmented Cardiac Lead for Left Bundle Branch Pacing and Defibrillation

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Solution Overview

Problem

Existing implantable cardiac stimulation leads cannot effectively combine left bundle branch pacing with defibrillation therapy due to the difficulty in fixing a lead at the right ventricle vertex while extending to the septum for left bundle branch stimulation.

Innovation Solution

A lead with a distal section of reduced bending stiffness, allowing flexible bending to place the pacing electrode near the left bundle branch and the defibrillation electrode near the right ventricle vertex, enabling simultaneous left bundle branch pacing and defibrillation therapy.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If the lead is rigid to maintain stable positioning, then the lead can be fixed at the right ventricle vertex, but the lead cannot extend flexibly to the septum for left bundle branch stimulation

Engineering Contradiction:
Improvelead positioning stabilityVSAvoidlead configuration flexibility
Core Design Contradiction:
Stability of the object's compositionVSAdaptability or versatility

Solution Approach 1:

The lead is divided into distinct sections with different mechanical properties: a proximal body section with higher bending stiffness for stable positioning at the right ventricle vertex, and a distal lead section with reduced bending stiffness for flexible extension to the septum. This segmentation allows each section to perform its specific function optimally without compromising the other.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

Different portions of the lead are assigned different local mechanical qualities. The body section maintains higher rigidity to ensure stable electrode positioning, while the distal lead section incorporates reduced bending stiffness to enable the lead to bend and reach the septum. This local differentiation of mechanical properties resolves the contradiction between stability and flexibility.

Inventive Principle:
Principle #3Local quality

2Adaptability or versatility

If the lead is made flexible to reach the septum, then the lead can extend to the left bundle branch, but the lead cannot maintain stable positioning for effective defibrillation

Engineering Contradiction:
Improvelead configuration flexibilityVSAvoidlead positioning stability
Core Design Contradiction:
Adaptability or versatilityVSStability of the object's composition

Solution Approach 1:

The lead structure is segmented into a flexible distal section for reaching the septum and a stable proximal body section for maintaining positioning. This segmentation ensures that flexibility is provided only where needed for navigation, while the body section maintains sufficient rigidity for stable electrode placement and effective defibrillation.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The lead exhibits local quality variations in bending stiffness along its length. The distal lead section has reduced bending stiffness to enable flexible extension to the septum, while the body section maintains higher bending stiffness to ensure stable positioning for defibrillation, thus resolving the contradiction between adaptability and stability.

Inventive Principle:
Principle #3Local quality

3Device complexity

If a single lead is used for both pacing and defibrillation, then device complexity is reduced, but the lead cannot simultaneously accommodate both electrode placement requirements

Engineering Contradiction:
Improvelead system complexityVSAvoidelectrode placement capability
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The lead is designed as a multi-functional device that can serve both pacing and defibrillation purposes. By incorporating a body section with defibrillation electrodes and a distal section that can be extended to the septum with pacing electrodes, the single lead performs multiple functions that would traditionally require separate leads, thereby reducing device complexity while maintaining versatility.

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

Solution Approach 2:

The lead is segmented into functional sections: the body section contains defibrillation electrodes for shock delivery, while the distal lead section can be positioned at the septum for pacing electrode placement. This functional segmentation within a single lead allows it to accommodate both pacing and defibrillation requirements without requiring multiple separate leads.

Inventive Principle:
Principle #1Segmentation

Data Source

PatentEP4051371B1Lead for an implantable stimulation device for cardiac stimulation of a patient
Publication Date: 2024.01.24 BIOTRONIK SE & CO KG
  • EP4051371B1 patent drawingFigure 1
  • EP4051371B1 patent drawingFigure 2
  • EP4051371B1 patent drawingFigure 3~4

AI summary

A lead (10) for an implantable stimulation device (1) for cardiac stimulation of a patient (P) generally extends along a longitudinal axis (L). The lead (10) comprises a body section (100), a distal lead section (101) extending from the body section (100) along the longitudinal axis (L) and forming a distal end (102), a first electrode device (14) arranged on the distal lead section (101) for at least one of transmitting an electrical pacing signal and sensing an electrical sense signal, the first electrode device (14) being configured for placement in or on intra-cardiac tissue (M), and a second electrode device (13) arranged on the body section (100) for emitting an electrical defibrillation signal. The distal lead section (101) in at least one portion comprises a reduced bending stiffness with respect to at least a portion of said body section (100).