Heart Valve Sealing Device Mitral Regurgitation Repair

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Solution Overview

Problem

Current methods for treating mitral valve regurgitation, such as surgical stitching and catheter-delivered clips, are invasive, stressful on patient leaflets, and restrict blood flow, with a need for improved devices and methods that effectively seal the native mitral valve while maintaining leaflet mobility and effective orifice area.

Innovation Solution

A valve repair device featuring a pair of clasps that attach to native valve leaflets, moving apart during diastole and together during systole to facilitate proper closure and prevent regurgitation, while allowing for leaflet mobility and maintaining an effective orifice area.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surgical stitching or catheter-delivered clips are used to treat mitral valve regurgitation, then the valve can be sealed to prevent regurgitation, but the procedure becomes invasive and places stress on patient leaflets while restricting blood flow

Engineering Contradiction:

Improvesealing effectivenessVSAvoidstress on leaflets and restriction of blood flow

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The device employs a flexible sealing element that conforms to the native valve leaflets, creating an effective seal without rigid structures that would stress the tissue. The flexible membrane allows natural leaflet movement while preventing regurgitation, resolving the contradiction between sealing effectiveness and stress reduction.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The sealing device is designed to be dynamic rather than static, allowing it to move with the cardiac cycle and accommodate natural leaflet motion. This dynamic design maintains effective orifice area during systole while providing sealing during diastole, reducing restriction of blood flow while maintaining sealing effectiveness.

Inventive Principle:

Principle #15Dynamics

2Reliability

If rigid sealing structures are used to prevent regurgitation, then sealing effectiveness improves, but leaflet mobility and effective orifice area are restricted

Engineering Contradiction:

Improvesealing effectivenessVSAvoidleaflet mobility

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The sealing element is constructed as a flexible thin film that can deform and move with the native leaflets, maintaining their natural mobility while providing the necessary sealing function. This flexible structure adapts to leaflet motion without restricting effective orifice area.

Inventive Principle:

Principle #30Flexible shells and thin films

Solution Approach 2:

The device acts as an intermediary between the leaflets and the regurgitant flow, providing sealing without directly constraining the leaflets themselves. The flexible sealing element mediates the interaction between leaflet motion and blood flow control, preserving adaptability while achieving reliability.

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS20220117729A1Heart valve sealing devices and delivery devices therefor

Publication Date: 2022.04.21 EDWARDS LIFESCIENCES CORP

AI summary

A valve repair device for repairing a native heart valve of a patient includes a pair of clasps, a pair of paddles, and a coupler. The clasps and paddles are configured to attach to native valve leaflets of the heart valve. The coupler is mechanically connected to the paddles. The coupler is configured to move the paddles between a partially open position and a closed position. The coupler is configured to move freely such that ends of the pair of paddles move away from one another when the native valve leaflets open during a diastolic phase of a cardiac cycle and the ends of the pair of paddles move toward one another when the native valve leaflets close during a ventricular systole of the cardiac cycle.