Ablation Balloon with Lasso Guide for Pulmonary Vein Isolation

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Solution Overview

Problem

Current methods for treating cardiac arrhythmias, such as atrial fibrillation, through cardiac catheterization are complex and require precise delivery of ablation devices to create circumferential lesions at the pulmonary vein ostia, which can be challenging and time-consuming for physicians.

Innovation Solution

A catheter system with a lasso guide and inflatable balloon having circumferentially arranged ablation electrodes, allowing for precise positioning and electrical isolation of the pulmonary vein by creating a circumferential lesion, facilitated by a method that includes pre- and post-ablation electrograms and contrast agent injection for accurate placement verification.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If a radially expandable ablation device with radiofrequency electrode is used to create circumferential lesions at pulmonary vein ostia, then effective electrical isolation of pulmonary veins can be achieved, but the procedure becomes complex and time-consuming for physicians

Engineering Contradiction:
Improveelectrical isolation of pulmonary veinsVSAvoidprocedure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The ablation balloon is nested within a delivery catheter, which is introduced percutaneously into the left atrium. The lasso guide is advanced through the catheter to engage the pulmonary vein, and the balloon is then deployed over the lasso guide. This nested configuration allows for simplified percutaneous access while maintaining the capability to deliver complex ablation functionality to the pulmonary vein ostia.

Inventive Principle:
Principle #7Nested doll (Nesting)

Solution Approach 2:

The lasso guide is advanced through the delivery catheter and engaged with the pulmonary vein interior wall before the ablation balloon is deployed. This preliminary positioning action establishes a stable foundation that simplifies subsequent balloon deployment and ensures accurate positioning at the pulmonary vein ostium, reducing procedural complexity and time.

Inventive Principle:
Principle #10Preliminary action

2Manufacturing precision

If precise delivery of ablation devices to pulmonary vein ostia is performed to create circumferential lesions, then effective arrhythmia treatment is achieved, but the procedure becomes challenging and time-consuming

Engineering Contradiction:
Improveprecise lesion placement at pulmonary vein ostiaVSAvoidprocedural time
Core Design Contradiction:
Manufacturing precisionVSLoss of time

Solution Approach 1:

The lasso guide serves as an intermediary device that is first advanced through the delivery catheter and engaged with the pulmonary vein interior wall. This intermediary structure provides a stable platform for subsequent balloon deployment, ensuring precise positioning at the pulmonary vein ostium without requiring complex direct manipulation, thereby reducing procedural time while maintaining precision.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The system replaces complex mechanical manipulation for precise positioning with a more straightforward deployment mechanism. The balloon is inflated against the pulmonary vein ostium after lasso guide engagement, using radial expansion force rather than complex mechanical positioning mechanisms, which simplifies the procedure and reduces time while maintaining precise lesion placement.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Ease of operation

If a catheter system with lasso guide and inflatable balloon is used for ablation, then procedure simplification is achieved, but device structure becomes more complex

Engineering Contradiction:
Improveprocedure simplicityVSAvoidcatheter system structure
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The catheter system is segmented into distinct functional components: a delivery catheter for percutaneous access, a lasso guide for pulmonary vein engagement, and an ablation balloon for lesion creation. This segmentation allows each component to perform its specific function efficiently, simplifying the overall procedure while the modular structure manages the inherent device complexity through functional specialization.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The delivery catheter serves multiple functions: it provides percutaneous access to the left atrium, serves as a conduit for the lasso guide, and supports the ablation balloon during deployment. This multi-functionality reduces the number of separate devices needed, simplifying the procedure while consolidating device complexity into a single versatile platform.

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

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

Simplifies the procedure for physicians by enabling precise and efficient delivery of ablation, effectively isolating the pulmonary vein from the left atrium, thereby addressing the complexity and time-consuming nature of existing methods.

Implementation Method 1

conducting electrical energy through the ablation electrodes to produce a circumferential lesion that circumscribes the pulmonary vein

Methodology Applied
Scientific EffectRadiofrequency ablation: Joule Heating

Implementation Method 2

deploying an inflated balloon over a portion of the lasso guide, the balloon having an electrode assembly disposed on an exterior wall thereof

Methodology Applied
Scientific EffectElastic expansion: Elasticity

Data Source

PatentEP3932304A1Balloon for ablation around pulmonary veins
Publication Date: 2022.01.05 BIOSENSE WEBSTER (ISRAEL) LTD
  • EP3932304A1 patent drawingFigure 1
  • EP3932304A1 patent drawingFigure 2
  • EP3932304A1 patent drawingFigure 3

AI summary

Cardiac ablation is carried out by introducing a catheter into the left atrium, extending a lasso guide through the lumen of the catheter to engage the wall of a pulmonary vein, and deploying a balloon over the lasso guide. The balloon has an electrode assembly disposed its exterior. The electrode assembly includes a plurality of ablation electrodes circumferentially arranged about the longitudinal axis of the catheter. The inflated balloon is positioned against the pulmonary vein ostium, so that the ablation electrodes are in galvanic contact with the pulmonary vein, and electrical energy is conducted through the ablation electrodes to produce a circumferential lesion that circumscribes the pulmonary vein.