Shape-Memory Stylet Ablation Catheter for Continuous Lesions

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Solution Overview

Problem

Existing ablation catheters face challenges in creating continuous, complete, and durable lesions for pulmonary vein isolation due to anatomical variations and inefficient thermal conductivity, leading to high pulmonary vein reconnection rates in atrial fibrillation treatments.

Innovation Solution

A cryoablation catheter with a shape-memory stylet that can be pre-set to match the desired lesion shape, allowing for adjustable flexibility and efficient cryogenic cooling to form continuous lesions, even in varying anatomical conditions.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional ablation catheters are used, then the procedure is simpler, but the lesions are discontinuous and pulmonary vein reconnection occurs frequently

Engineering Contradiction:
Improvepulmonary vein isolation durabilityVSAvoidcatheter structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The catheter shaft is divided into multiple segmented sections that can independently articulate and adjust to anatomical variations, allowing the catheter to conform to the pulmonary vein geometry while maintaining continuous lesion formation

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter incorporates dynamic articulation capabilities with multiple degrees of freedom, enabling real-time adjustment of the catheter shape to match the target anatomy and ensure continuous contact for durable lesion creation

Inventive Principle:
Principle #15Dynamics

2Adaptability or versatility

If the catheter is made flexible to adapt to anatomical variations, then adaptability improves, but thermal conductivity efficiency decreases

Engineering Contradiction:
Improveanatomical adaptation capabilityVSAvoidthermal energy loss
Core Design Contradiction:
Adaptability or versatilityVSLoss of energy

Solution Approach 1:

The catheter employs composite construction with thermally conductive core materials for efficient cryogen transfer, surrounded by flexible articulation sections that provide anatomical adaptability while minimizing thermal energy loss through optimized material layering

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

The catheter design incorporates intermediary thermal coupling sections that maintain efficient heat transfer between the cryogen source and target tissue while accommodating anatomical variations, acting as a bridge between flexibility requirements and thermal efficiency

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If multiple ablation points are added to prevent gaps, then isolation completeness improves, but procedure time increases

Engineering Contradiction:
Improveisolation completenessVSAvoidprocedure time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The catheter is designed to form continuous lesions in a single pass by maintaining constant contact with the tissue surface through its articulation capabilities, eliminating the need for multiple discrete ablation points and reducing procedure time while ensuring complete isolation

Inventive Principle:
Principle #20Continuity of useful action

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

The cryoablation catheter effectively forms continuous lesions, enhancing pulmonary vein isolation and reducing reconnection rates by ensuring complete electrical signal isolation in the heart chambers.

Implementation Method 1

the stylet comprises a shape-memory material. In some embodiments, at least a distal portion of the stylet is pre-set with a shape that corresponds to a desired shape of the lesion to be formed

Methodology Applied
Scientific EffectShape memory: Shape Memory Alloy

Implementation Method 2

A cryoablation catheter with a shape-memory stylet that can be pre-set to match the desired lesion shape, allowing for adjustable flexibility and efficient cryogenic cooling to form continuous lesions

Methodology Applied
Scientific EffectCryogenic cooling: Cryogenics

Data Source

PatentEP3678567B1Ablation catheter having a shape memory stylet
Publication Date: 2025.09.17 ADAGIO MEDICAL
  • EP3678567B1 patent drawingFigure 1
  • EP3678567B1 patent drawingFigure 2
  • EP3678567B1 patent drawingFigure 3

AI summary

An ablation apparatus for creating a lesion in target tissue, the ablation apparatus having an ablation shaft including a handle, a first portion, an ablation portion, distal tip, at least one ablation energy delivery lumen, at least one ablation energy return lumen, and a stylet lumen that extends substantially along a length of the ablation shaft from the handle to at least the ablation portion. The ablation apparatus also includes a stylet that is capable of being inserted into the stylet lumen where the stylet is made of a shape-memory material.