Prosthetic Valve Leaflet Frames with Projection-Locked Coupling

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Prosthetic valves with flexible leaflets face issues with securing leaflets to a support structure, such as suturing being labor-intensive and adhesive bonds being negatively impacted in aqueous environments, affecting long-term functionality and structural integrity.

Innovation Solution

Mechanically coupling leaflets to a leaflet frame using leaflet frame projections that extend through apertures in the leaflet attachment region, with restraining members to impede decoupling, and using deformable or attachable locking bars for additional retention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If suturing is used to secure leaflets to the leaflet frame, then the leaflets can be mechanically attached, but the process becomes labor-intensive and the quality depends on assembler skill

Engineering Contradiction:

Improveleaflet attachment integrityVSAvoidmanufacturing complexity

Core Design Contradiction:

ReliabilityVSEase of manufacture

Solution Approach 1:

The patent replaces the manual suturing mechanical system with an integrated mechanical attachment system consisting of leaflet frame projections that extend through leaflet apertures and engage with restraining members. This substitution eliminates the need for manual needle threading and knot tying, thereby reducing labor intensity and eliminating dependence on assembler skill while maintaining secure mechanical attachment of leaflets to the frame.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Ease of manufacture

If adhesive bonding is used to secure leaflets to the leaflet frame, then the attachment process is simplified, but the bond integrity is negatively impacted in aqueous environments

Engineering Contradiction:

Improveattachment process simplicityVSAvoidbond integrity in aqueous environment

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent replaces adhesive bonding with a purely mechanical attachment system using leaflet frame projections and restraining members. This substitution eliminates the chemical bond entirely, replacing it with physical mechanical engagement that remains intact in aqueous environments. The projections extend through apertures and are secured by restraining members such as locking bars or clips, providing reliable mechanical retention without susceptibility to hydrolysis or adhesive degradation.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Solution Approach 2:

The patent changes the attachment mechanism from chemical bonding (adhesive) to mechanical bonding (projections and restraining members). This parameter change in the attachment method fundamentally alters how the leaflets are secured, transitioning from a chemistry-based solution vulnerable to aqueous environments to a mechanics-based solution that maintains integrity in bodily fluids.

Inventive Principle:

Principle #35Parameter changes

3Strength

If tension is applied to sutures to secure leaflets, then the leaflets are attached to the frame, but the local geometries of the leaflet may be adversely affected

Engineering Contradiction:

Improveleaflet attachment strengthVSAvoidleaflet local geometry

Core Design Contradiction:

StrengthVSShape

Solution Approach 1:

The patent replaces the tension-based suture system with a projection-based mechanical system where leaflet frame projections extend through leaflet apertures and are secured by restraining members. This substitution allows for secure attachment without the need to apply tensile forces that would distort the leaflet tissue, thereby maintaining the natural local geometry while achieving strong mechanical attachment.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Reliability

If multiple attachment methods (suturing or adhesive) are used to secure leaflets, then the attachment can be achieved, but the manufacturing time and labor increase

Engineering Contradiction:

Improveleaflet attachment reliabilityVSAvoidmanufacturing throughput

Core Design Contradiction:

ReliabilityVSProductivity

Solution Approach 1:

The patent replaces complex multi-step attachment processes (suturing or adhesive application) with a single integrated mechanical attachment step using projections and restraining members. This substitution streamlines the manufacturing process, allowing for rapid assembly of the valve components while maintaining secure and reliable leaflet attachment, thereby significantly improving manufacturing throughput.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentUS12419740B2Prosthetic valved conduits with mechanically coupled leaflets

Publication Date: 2025.09.23 EDWARDS LIFESCIENCES CORP

AI summary

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a non-sewn mechanically coupled leaflet. The described leaflet frames have projections that are configured to couple with apertures located within the leaflet attachment region of a leaflet. Some embodiments are further directed toward pulmonary valved conduits incorporating such leaflet and leaflet frame constructs. Methods of making and using such prosthetic valve devices are also described amongst others.