LAA Occluder with Cryoablation for Electrical Isolation

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Solution Overview

Problem

Conventional catheter ablation methods for atrial fibrillation are challenging due to long operation times, large ablation areas, incomplete ablation, and the risk of thromboembolic events associated with passive left atrial appendage isolation, which can lead to recurrence of atrial fibrillation and cerebrovascular embolism.

Innovation Solution

An LAA occluder system with a sealing portion and ablation member that forms an annular isolation band on the inner wall of the LAA using cryogen, blocking electrical signals between the LAA and the left atrium, thereby achieving electrical isolation and occlusion, reducing the risk of thrombus formation and operational difficulties.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If conventional catheter ablation is performed for atrial fibrillation, then electrical isolation can be achieved, but the operation time is long and the ablation area is large

Engineering Contradiction:
Improveelectrical isolation effectivenessVSAvoidoperation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent segments the ablation procedure into two distinct components: (1) mechanical occlusion of the LAA ostium using an occluder device to physically isolate the appendage, and (2) targeted cryoablation of a limited area around the ostium to create an annular isolation band. This segmentation allows each component to perform its specific function efficiently, avoiding the need for extensive circumferential ablation of the entire LAA, thereby significantly reducing operation time while maintaining electrical isolation effectiveness.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent merges the occlusion function and ablation function into a single integrated device system. The occluder device with the cryoablation balloon can be deployed simultaneously to achieve both mechanical occlusion and thermal ablation in one procedure. This merging eliminates the need for separate ablation procedures, reduces overall operation time, and ensures coordinated action between occlusion and isolation band formation.

Inventive Principle:
Principle #5Merging (Combining)

2Reliability

If aggressive ablation is performed in the left atrium to achieve complete isolation, then electrical isolation effectiveness improves, but the ablation area increases and completeness cannot be ensured

Engineering Contradiction:
Improveelectrical isolation completenessVSAvoidablation area
Core Design Contradiction:
ReliabilityVSArea of stationary object

Solution Approach 1:

The patent applies local quality by concentrating the ablation energy specifically at the LAA ostium region where electrical isolation is most critical. The cryoablation balloon is positioned precisely at the ostium to create an annular isolation band, rather than diffusely ablating large areas of the left atrium. This localized approach ensures complete isolation at the critical site while minimizing the total ablation area and avoiding unnecessary damage to surrounding healthy tissue.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent replaces extensive mechanical/catheter-based ablation with a more precise cryoablation system. Instead of using large catheters to create extensive lesion sets throughout the left atrium, the system uses a cryoablation balloon that can be precisely positioned and inflated to create a controlled, complete annular isolation band at the ostium, achieving more complete isolation with less total tissue damage.

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

3Reliability

If passive left atrial appendage isolation occurs during ablation, then electrical isolation may be achieved, but the risk of thromboembolic events increases

Engineering Contradiction:
Improveelectrical isolationVSAvoidthromboembolic risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent applies preliminary action by performing mechanical occlusion of the LAA ostium BEFORE performing the cryoablation procedure. The occluder device is deployed first to physically seal the appendage, preventing thrombus formation and embolization during the subsequent ablation process. This preliminary occlusion protects against thromboembolic events while the cryoablation creates the electrical isolation band, allowing safe achievement of electrical isolation without exposing patients to thrombotic risks during the procedure.

Inventive Principle:
Principle #10Preliminary action

4Reliability

If circumferential pulmonary vein ablation is performed, then atrial fibrillation can be terminated, but the operation time increases and recurrence risk remains

Engineering Contradiction:
Improveatrial fibrillation terminationVSAvoidoperation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent extracts the LAA isolation component from the comprehensive circumferential pulmonary vein ablation procedure. Instead of performing extensive ablation around all pulmonary veins, the system specifically targets and isolates the LAA ostium with cryoablation while it is occluded. This extracted, focused approach addresses the critical thrombus-generating site efficiently, reducing operation time while maintaining effectiveness in preventing atrial fibrillation recurrence related to LAA activity.

Inventive Principle:
Principle #2Taking out (Extraction)

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 LAA occluder system effectively reduces the risk of stroke by ensuring long-term maintenance of sinus rhythm and minimizing the occurrence of thromboembolic events while simplifying the procedure and reducing the risk of atrial fibrillation recurrence.

Implementation Method 1

The ablation portion is configured to freeze an LAA after being injected with cryogen so as to form an annular isolation band on an inner wall of the LAA

Methodology Applied
Scientific EffectCryogen injection freezing: Freezing

Data Source

PatentUS11963708B2Left atrial appendage occluder and occlusion system
Publication Date: 2024.04.23 LIFETECH SCI (SHENZHEN) CO LTD
  • US11963708B2 patent drawing
  • US11963708B2 patent drawing
  • US11963708B2 patent drawing

AI summary

A left atrial appendage (LAA) occluder and an occluding system are provided. The LAA occluder includes a sealing portion and an ablation portion arranged in the sealing portion, as well as a hollow proximal connector at a proximal end of the sealing portion. The ablation portion is connected to the proximal connector. The ablation portion is used to freeze an LAA after being injected with cryogen so as to form an annular isolation band on an inner wall of the LAA for blocking the conduction of electrical signals between the LAA and a left atrium.