Shape-Memory Ablation Catheter for Complete Pulmonary Vein Isolation

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Solution Overview

Problem

Existing ablation catheters face challenges in creating continuous and complete lesions in the heart tissue due to varying anatomical contours and patient anatomy variations, leading to incomplete pulmonary vein isolation and high recurrence rates of atrial fibrillation.

Innovation Solution

A cryoablation catheter with a shape-memory stylet and adjustable shape, combined with pulsed field ablation, to ensure complete tissue contact and efficient lesion formation, using a shape-memory material for the stylet to match tissue contours and electrodes for pulsed field ablation to enhance lesion depth and reduce procedure time.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a traditional rigid ablation catheter is used, then the structure is simple and easy to manufacture, but the catheter cannot adapt to varying anatomical contours and patient anatomy variations, leading to incomplete pulmonary vein isolation

Engineering Contradiction:

Improveadaptability to anatomical contoursVSAvoidcatheter structure complexity

Core Design Contradiction:

Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The catheter incorporates a shape-memory stylet that allows the catheter shaft to dynamically change its shape in response to anatomical contours. The stylet can be adjusted between straight and curved configurations, enabling the catheter to adapt to different patient anatomies while maintaining a relatively simple overall structure.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The catheter utilizes a shape-memory material for the stylet that can change its physical parameters (shape, curvature) in response to temperature changes or mechanical activation. This allows the catheter to transform from a straight configuration during insertion to a curved configuration for optimal tissue contact during ablation.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If multiple ablation points are used to ensure complete isolation, then the isolation durability is improved, but the procedure time increases significantly

Engineering Contradiction:

Improveisolation durabilityVSAvoidprocedure time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

The catheter is designed to create continuous circumferential lesions around the pulmonary veins in a single pass. The shape-memory stylet enables the catheter to maintain continuous contact with the tissue around the entire pulmonary vein circumference, allowing complete isolation to be achieved in one continuous ablation process rather than requiring multiple discrete ablation points.

Inventive Principle:

Principle #20Continuity of useful action

3Object-affected harmful factors

If cryoablation is used to create lesions, then thermal damage to surrounding tissue is minimized, but the lesion formation time may be extended

Engineering Contradiction:

Improvethermal damage to surrounding tissueVSAvoidlesion formation time

Core Design Contradiction:

Object-affected harmful factorsVSLoss of time

Solution Approach 1:

The catheter ensures optimal positioning and continuous tissue contact is established before initiating cryoablation. The shape-memory stylet is pre-configured to match the anatomical contour, and the catheter is pre-positioned to ensure complete circumferential contact with the pulmonary vein tissue, allowing cryoablation to proceed efficiently without requiring extended contact times.

Inventive Principle:

Principle #10Preliminary 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 catheter achieves durable electrical signal isolation with reduced procedure time and minimal adverse effects by ensuring complete lesion formation and minimizing thermal damage, enhancing treatment efficacy for atrial fibrillation and other heart conditions.

Implementation Method 1

the stylet includes a shape-memory material and has a preset shape that corresponds to a desired shape of the catheter when deployed

Methodology Applied

Scientific EffectShape memory effect: Shape Memory Alloy

Implementation Method 2

A cryoablation catheter with a shape-memory stylet and adjustable shape, combined with pulsed field ablation, to ensure complete tissue contact and efficient lesion formation

Methodology Applied

Scientific EffectFreezing: Freezing

Data Source

PatentUS20260076728A1Multi-modality ablation catheter having a shape memory stylet

Publication Date: 2026.03.19 ADAGIO MEDICAL

AI summary

A multimodality or hybrid ablation system includes an ablation apparatus for creating a lesion in target tissue. The ablation apparatus has 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. A plurality of electrodes are arranged on the ablation portion for measuring or verifying tissue contact with the tissue and applying a pulsed electric field. Optionally, the pulsed electric field may be applied after, contemporaneously, or for only a portion that the cryo-modality is applied to the target tissue.