Reinforced Electrophysiology Balloon Catheter Tails Against Delamination

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Solution Overview

Problem

Balloon catheters used for cardiac tissue ablation face challenges in withstanding multiple cycles of deployment, expansion, and withdrawal due to potential delamination of components, which can be exacerbated by friction and stress, affecting the integrity and functionality of the catheter.

Innovation Solution

A reinforcement component with a horn-like shape is applied over the tails of the balloon membrane, combined with a filament to enhance the connection between the substrate and membrane, reducing the likelihood of delamination and stress, while maintaining the catheter's flexibility and electrical contact.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If the balloon membrane is made flexible to allow repeated expansion and collapse cycles, then the ease of operation is improved, but the reliability deteriorates due to potential delamination of substrates and tails from the membrane

Engineering Contradiction:
Improveflexibility for repeated expansion and collapseVSAvoidattachment integrity of substrates and tails
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

A reinforcement member is attached to the balloon membrane before the substrates and tails are attached to the membrane. This reinforcement member acts as a protective layer that distributes mechanical stresses and prevents direct contact between the flexible membrane and the attachment interfaces, thereby preventing delamination during repeated expansion and collapse cycles while maintaining membrane flexibility

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The balloon structure employs a composite design with multiple layers: the flexible membrane, a reinforcement member layer, and substrate/tail assemblies. This composite structure combines the flexibility of the membrane with the structural integrity of the reinforcement member, allowing repeated deformation cycles without delamination while maintaining ease of operation

Inventive Principle:
Principle #40Composite materials

2Reliability

If the balloon structure is reinforced to prevent delamination, then the reliability is improved, but the device complexity increases due to additional reinforcement components

Engineering Contradiction:
Improveresistance to delaminationVSAvoidnumber of reinforcement components
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The reinforcement function is segmented into modular components - the reinforcement member is divided into multiple segments corresponding to different regions of the balloon membrane. Each segment can be independently attached to reinforce specific areas where substrates and tails are attached, providing targeted reinforcement without requiring a complete reinforcement layer across the entire balloon, thus reducing overall device complexity

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The reinforcement member is strategically positioned only at specific locations on the balloon membrane where substrates and tails are attached, rather than covering the entire membrane. This localized reinforcement approach provides delamination prevention exactly where needed while minimizing the addition of device complexity and maintaining a relatively simple overall structure

Inventive Principle:
Principle #3Local quality

Data Source

PatentEP3586778B1Reinforcement for irrigated electrophysiology balloon catheter with flexible-circuit electrodes
Publication Date: 2026.02.25 BIOSENSE WEBSTER (ISRAEL) LTD
  • EP3586778B1 patent drawingFigure 1
  • EP3586778B1 patent drawingFigure 2
  • EP3586778B1 patent drawingFigure 3

AI summary

A balloon of a balloon catheter must be able to withstand fatigue to its componentry caused by multiple cycles of repeat motions, such as deployment from a lumen of the catheter, expanding the balloon, collapsing the balloon, and withdrawal of the balloon into the lumen. The catheter balloon may include plurality of electrode substrates, each including a plurality of tails. A reinforcement component, which may be a portion of another balloon, may be disposed over at least some of the plurality of tails and attached to the membrane. Where tails are provided on the proximal and distal ends of the balloon, two reinforcement mechanisms may be used.