LAA Occluder Delivery Device with Ablation Balloon

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Solution Overview

Problem

Current medical devices are inadequate for simultaneously occluding and ablating the left atrial appendage (LAA) during atrial fibrillation, leading to increased risk of embolic strokes due to blood stagnation and clot formation, and often require separate procedures, which complicate treatment and extend the time frame.

Innovation Solution

A medical device comprising a catheter with an occluder and an inflatable balloon equipped with ablation electrodes, allowing for simultaneous occlusion and ablation of the LAA via transcatheter delivery, where the occluder is anchored within the LAA and the balloon delivers ablation energy to electrically isolate the tissue, reducing the risk of clot formation and stroke.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If separate occlusion and ablation procedures are used, then each procedure can be optimized independently, but treatment complexity increases and treatment time extends

Engineering Contradiction:
Improveprocedure optimizationVSAvoidtreatment complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines occlusion and ablation functions into a single integrated device. The occluder device includes an occlusion element for closing the LAA and an ablation element for delivering energy to ablate tissue, allowing both functions to be performed in one procedure rather than requiring separate procedures.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The occluder device is designed with multi-functionality, serving both as an occlusion device and an ablation device. The single device can perform both mechanical occlusion of the LAA and thermal or electrical ablation of the tissue, eliminating the need for multiple specialized devices.

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

2Reliability

If separate occlusion and ablation procedures are used, then each procedure can be optimized independently, but treatment time frame extends

Engineering Contradiction:
Improveprocedure optimizationVSAvoidtreatment time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent combines occlusion and ablation functions into a single integrated device. The occluder device includes an occlusion element for closing the LAA and an ablation element for delivering energy to ablate tissue, allowing both functions to be performed in one procedure rather than requiring separate procedures.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The device allows the occluder to be deployed first to establish occlusion, then the ablation element is activated to deliver energy to the tissue. This preliminary deployment followed by ablation sequence optimizes the treatment process by ensuring proper positioning before energy delivery.

Inventive Principle:
Principle #10Preliminary action

3Device complexity

If conventional occlusion devices are used without ablation capability, then device simplicity is maintained, but subsequent ablation therapy is prevented

Engineering Contradiction:
Improvedevice simplicityVSAvoidtreatment flexibility
Core Design Contradiction:
Device complexityVSAdaptability or versatility

Solution Approach 1:

The occluder device is designed with multi-functionality, serving both as an occlusion device and an ablation device. The single device can perform both mechanical occlusion of the LAA and thermal or electrical ablation of the tissue, eliminating the need for multiple specialized devices.

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

Solution Approach 2:

The patent combines occlusion and ablation functions into a single integrated device. The occluder device includes an occlusion element for closing the LAA and an ablation element for delivering energy to ablate tissue, allowing both functions to be performed in one procedure rather than requiring separate procedures.

Inventive Principle:
Principle #5Merging (Combining)

4Reliability

If surgical occlusion techniques are used, then complete occlusion can be achieved, but invasiveness and patient risk increase

Engineering Contradiction:
Improveocclusion effectivenessVSAvoidpatient risk
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces surgical mechanical occlusion techniques with a transcatheter-delivered device that uses mechanical expansion and energy delivery for ablation. The occluder is delivered through a catheter and deployed within the LAA, avoiding the need for open surgery while achieving effective occlusion.

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

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 device effectively occludes the LAA, preventing blood clotting and ablating tissue to restore normal heart rhythms, thereby reducing the risk of embolic strokes and simplifying the treatment process by combining occlusion and ablation in a single procedure.

Implementation Method 1

an ablation electrode disposed on the balloon and configured to deliver ablation energy to tissue of the left atrial appendage

Methodology Applied
Scientific EffectAblation: Ablation

Data Source

PatentEP3970634A1Left atrial appendage occluder delivery device incorporating ablation functionality
Publication Date: 2022.03.23 ST JUDE MEDICAL CARDILOGY DIV INC
  • EP3970634A1 patent drawingFigure 1
  • EP3970634A1 patent drawingFigure 2
  • EP3970634A1 patent drawingFigure 3

AI summary

A heart treatment device includes a delivery device allowing for simultaneous ablation of the left atrial appendage and delivery of an occluder into the left atrial appendage. The device includes a steerable catheter, an occluder releasably disposed within the catheter, an inflatable balloon coupled to a distal end of the catheter, and an array of electrodes coupled to the balloon. The balloon may be inflated to bring the electrodes into contact with the interior wall of the left atrial appendage. Energy supplied to the electrodes through the catheter ablates the tissue of the left atrial appendage to electrically isolate the left atrial appendage from the heart, and the delivery device deploys the occluder in the left atrial appendage.