LAA Closure Cinching Member for Complete Sealing

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Solution Overview

Problem

Existing medical devices for closing the left atrial appendage (LAA) often fail to achieve complete sealing due to anatomical irregularities and tissue motion, leading to potential leaks and complications such as stroke or heart attack.

Innovation Solution

A medical system comprising an expandable framework for the LAA closure device and a balloon expandable cinching member with tissue engagement elements, designed to shift between configurations to ensure complete occlusion of the LAA.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If existing medical devices are deployed to close off the left atrial appendage, then the device can be implanted, but complete sealing is not achieved due to anatomical irregularities and tissue motion

Engineering Contradiction:

Improvesealing completenessVSAvoidanatomical adaptation

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The closure device incorporates a cinching member that can dynamically adjust its position and tension to accommodate tissue motion and anatomical irregularities. The cinching member transitions from a relaxed state during delivery to a tightened state during deployment, allowing the device to adapt to the living tissue environment and maintain complete sealing despite anatomical variations and tissue movement.

Inventive Principle:

Principle #15Dynamics

Solution Approach 2:

The device utilizes changes in the cinching member's dimensional parameters (diameter, tension) to achieve proper sealing. The cinching member is compressed to a smaller diameter for delivery through the catheter, then expanded to a larger diameter that engages with the LAA ostium, allowing the system to adapt to different anatomical sizes and shapes while maintaining complete occlusion.

Inventive Principle:

Principle #35Parameter changes

2Reliability

If a cinching member is added to achieve complete closure, then sealing is improved, but device complexity increases

Engineering Contradiction:

Improveclosure completenessVSAvoiddevice structure

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The cinching member is integrated with the closure device framework, combining the sealing function with the structural support function into a single unified device. This merging reduces the number of separate components and simplifies the overall device architecture while maintaining complete closure capability through the coordinated action of the framework and cinching member.

Inventive Principle:

Principle #5Merging (Combining)

Solution Approach 2:

The cinching member serves multiple functions: it provides structural support for the closure device, engages with the LAA ostium tissue to prevent leakage, and can be adjusted to accommodate different anatomical configurations. This multi-functionality reduces the need for additional separate components, thereby simplifying the overall device structure while achieving reliable closure.

Inventive Principle:

Principle #6Universality (Multi-functionality)

3Ease of operation

If the cinching member is made balloon expandable, then ease of delivery is improved, but manufacturing precision requirements increase

Engineering Contradiction:

Improvedelivery easeVSAvoidexpansion control

Core Design Contradiction:

Ease of operationVSManufacturing precision

Solution Approach 1:

A balloon catheter serves as an intermediary tool to control the expansion of the cinching member during delivery. The balloon is inflated to a controlled pressure that causes the cinching member to expand from its compressed delivery state to its operational state, providing precise control over the expansion process and enabling easy delivery through the catheter while maintaining manufacturing precision.

Inventive Principle:

Principle #24Intermediary (Mediator)

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 system effectively achieves complete closure of the LAA, preventing leaks and reducing the risk of thrombi formation and subsequent cardiovascular events.

Implementation Method 1

the cinching member is balloon expandable until an outer diameter of the cinching member is larger than an inner diameter of a patient's left atrial appendage

Methodology Applied

Scientific EffectBalloon expansion:

Implementation Method 2

the plurality of tissue engagement elements are radially extending hooks

Methodology Applied

Scientific EffectMechanical engagement: Mechanical Force

Data Source

PatentUS20250099105A1Medical system for left atrial appendage ostial cinching

Publication Date: 2025.03.27 BOSTON SCIENTIFIC SCIMED INC

AI summary

A medical system may include a left atrial appendage closure device including an expandable framework configured to shift between a collapsed delivery configuration and an expanded deployed configuration. The expandable framework has an outer diameter in the expanded deployed configuration. The medical system also includes a cinching member configured to shift between a compressed delivery configuration and an expanded configuration. The cinching member is ring shaped with an inner diameter in the expanded configuration that is larger than the outer diameter of the left atrial appendage closure device, and the cinching member has a plurality of tissue engagement elements defined on an outer surface thereof.