LAA Exclusion Device Rounded Contact and Flexible Cover

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Solution Overview

Problem

Existing methods for excluding the left atrial appendage (LAA) to prevent embolic strokes in patients with atrial fibrillation are invasive and risk causing tissue necrosis or bleeding due to uneven compressive force and punctures.

Innovation Solution

A device with elongate members that compress the LAA without causing necrotic tissue, featuring rounded contact points and a flexible mesh cover to minimize stress concentrations and prevent bleeding, allowing for easy application and effective exclusion of the LAA.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If an externally applied device compresses the LAA to exclude it, then the exclusion function is achieved, but tissue necrosis may occur due to excessive or uneven compressive force

Engineering Contradiction:

Improveexclusion functionVSAvoidtissue necrosis

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The compression members feature rounded contact surfaces that distribute compressive force across a larger area of the LAA, creating localized zones of reduced pressure that prevent tissue necrosis while maintaining effective exclusion. This local modification of the contact interface quality resolves the contradiction between achieving compression and avoiding tissue damage.

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The device incorporates a flexible mesh cover that acts as a cushioning layer between the compression members and the LAA tissue. This protective covering is applied beforehand to prevent direct concentrated compression, thereby preventing tissue necrosis while still allowing the device to achieve the necessary exclusion function through distributed pressure.

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

2Ease of operation

If an externally applied device is used to close the LAA, then the procedure is simpler and less invasive, but unintended hemorrhaging may occur due to punctures in the LAA surface

Engineering Contradiction:

Improveapplication simplicityVSAvoidhemorrhaging

Core Design Contradiction:

Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The device employs a flexible mesh cover that conforms to the LAA surface without requiring punctures or incisions. This flexible film approach maintains ease of external application while eliminating the hemorrhaging risk associated with puncture-based closure methods, as the cover gently envelops the LAA without penetrating the tissue.

Inventive Principle:

Principle #30Flexible shells and thin films

3Reliability

If compression force is increased to ensure effective exclusion, then the exclusion reliability improves, but stress concentrations develop leading to necrotic tissue

Engineering Contradiction:

Improveexclusion effectivenessVSAvoidstress concentration

Core Design Contradiction:

ReliabilityVSStress or pressure

Solution Approach 1:

The compression members are designed with rounded, curved contact surfaces rather than flat or sharp edges. This spheroidal geometry distributes stress evenly across the LAA surface, preventing stress concentration points that would lead to necrotic tissue, while still maintaining sufficient compression force for effective exclusion through the curved contact interface.

Inventive Principle:

Principle #14Spheroidality (Curvature)

Data Source

PatentUS10426488B2Exclusion of the left atrial appendage

Publication Date: 2019.10.01 MICHLER ROBERT E

AI summary

A device for excluding the left atrial appendage (LAA) includes first and second members, each with first and second ends. The second ends are connected by a hinge. The first ends interlock to close the device about the LAA. The members are shaped such that they can exclude the LAA without causing the development of necrotic tissue. If desired, a flexible cover can be provided and the first and second members can be disposed within the cover. If such a cover is used, it will contact the LAA in order to cushion the contact between the members and the LAA and minimize the tendency of the LAA to bleed. The invention also includes methods for using the device to exclude the LAA.