Localized Native Valve Leaflet Fusion With Activated Adhesive

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Solution Overview

Problem

Existing methods for treating valvular regurgitation, such as mitral valve regurgitation, involve deploying clips or devices that require permanent implants, posing risks of tissue damage and device dislodgement.

Innovation Solution

A delivery device is used to apply a biocompatible adhesive between valve leaflets, which is cured using ultraviolet radiation, eliminating the need for permanent implants and minimizing tissue damage by allowing repositioning without mechanical gripping.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If clips or permanent implants are used to hold valve leaflets together, then the valve regurgitation can be corrected, but tissue damage and device dislodgement risks increase

Engineering Contradiction:

Improvevalve regurgitation correctionVSAvoidtissue damage and device dislodgement

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent replaces mechanical clipping systems with a chemical bonding system using photopolymerizable adhesive. The adhesive is applied between valve leaflets and cured with UV light to create a permanent fusion without mechanical gripping structures, thereby eliminating the risks of mechanical tissue damage and device dislodgement associated with clips

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The adhesive transitions from an uncured liquid or semi-liquid state to a cured solid state through UV irradiation. This parameter change (curing) transforms the adhesive from a flexible, repositionable state to a rigid, permanent bond state, enabling reliable valve leaflet fusion without the need for permanent mechanical implants

Inventive Principle:

Principle #35Parameter changes

2Reliability

If clips are deployed to hold leaflets together, then valve function can be improved, but the need for permanent implants increases

Engineering Contradiction:

Improvevalve functionVSAvoidpermanent implant requirement

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The invention substitutes mechanical clipping devices with a chemical adhesive system that cures to form a permanent bond. This eliminates the need for complex mechanical implant structures while achieving the same valve function improvement through chemical fusion of the leaflets

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent extracts and eliminates the permanent implant component from the treatment system. By using a photopolymerizable adhesive that cures in situ, the solution removes the need for separate permanent mechanical implants, simplifying the overall device complexity while maintaining valve function

Inventive Principle:

Principle #2Taking out (Extraction)

3Reliability

If mechanical gripping devices are used, then valve leaflets can be held together, but repositioning capability is lost

Engineering Contradiction:

Improveleaflet holdingVSAvoidrepositioning capability

Core Design Contradiction:

ReliabilityVSAdaptability or versatility

Solution Approach 1:

The adhesive system provides dynamic repositioning capability during the uncured state, allowing the delivery device to adjust and reposition the adhesive application site. Once cured with UV light, the adhesive becomes static and permanent, providing reliable holding without the need for repositioning. This dynamic-to-static transition resolves the contradiction between holding reliability and repositioning adaptability

Inventive Principle:

Principle #15Dynamics

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 biocompatible adhesive effectively fuses valve leaflets together, reducing regurgitation without the risks associated with permanent implants, and can be repositioned as needed, thus minimizing tissue damage and device dislodgement.

Implementation Method 1

A delivery device is used to apply a biocompatible adhesive between valve leaflets, which is cured using ultraviolet radiation

Methodology Applied

Scientific EffectPhotopolymerization: Photopolymerisation

Data Source

PatentUS12419622B2Localized fusion of native leaflets using activated adhesive

Publication Date: 2025.09.23 EDWARDS LIFESCIENCES CORP

AI summary

Disclosed is a delivery device, kit, system, method, etc. for localized fusion of leaflets of a tissue valve, for example, a native heart valve, using an adhesive. The delivery device can have one or more capture features for capturing separate leaflets, for example, the anterior and posterior mitral leaflets. An applicator can be configured to apply a biocompatible adhesive between the captured leaflets, and one or more curing elements can be configured to cure the applied biocompatible adhesive. The kit can have the aforementioned delivery device, and the biocompatible adhesive used therewith. The method can include positioning the aforementioned delivery device adjacent the anterior and posterior mitral leaflets, capturing the mitral leaflets between the paddles of the delivery device, applying a biocompatible adhesive between the captured mitral leaflets via the applicator, and curing the applied biocompatible adhesive via the energy elements to locally fuse the mitral leaflets.