Prosthetic Valve Leaflets Mechanical Coupling

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Solution Overview

Problem

Prosthetic valves with flexible leaflets face challenges in securing leaflets to a support structure due to the limitations of suturing and adhesive/thermal bonding, which affect the long-term functionality and structural integrity, especially in aqueous environments.

Innovation Solution

The use of a leaflet frame with projections that extend through apertures in the leaflet attachment region, combined with restraining elements like deformable or attachable locking bars, to mechanically couple and retain the leaflets, preventing decoupling during valve operation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If adhesive bonding is used to secure leaflets to the support structure, then the attachment process is simplified, but the bond integrity deteriorates in aqueous environments over time

Engineering Contradiction:

Improveattachment process simplicityVSAvoidbond integrity

Core Design Contradiction:

Ease of manufactureVSReliability

Solution Approach 1:

The patent replaces adhesive/chemical bonding with a mechanical interlocking system consisting of leaflet frame projections that extend through apertures in the leaflet attachment region. The projections are retained by restraining members that provide mechanical interference to prevent decoupling, thereby substituting chemical adhesion with mechanical retention that maintains integrity in aqueous environments.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

2Strength

If suturing is used to secure leaflets to the support structure, then the attachment strength is improved, but the manufacturing complexity and labor intensity increase

Engineering Contradiction:

Improveattachment strengthVSAvoidassembly process complexity

Core Design Contradiction:

StrengthVSDevice complexity

Solution Approach 1:

The patent segments the attachment system into distinct components: leaflet frame projections, leaflet apertures, and restraining members. This segmentation allows for standardized manufacturing of each component and simplifies the overall assembly process while maintaining attachment strength through the mechanical interlocking of these discrete elements.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The leaflet frame projections serve as intermediary elements that mediate between the support structure and the leaflets. These projections extend through apertures in the leaflet attachment region and are retained by restraining members, providing a standardized mechanical interface that simplifies assembly while maintaining strong attachment.

Inventive Principle:

Principle #24Intermediary (Mediator)

3Strength

If high tension is applied to sutures to secure leaflets, then the attachment firmness is improved, but the local leaflet geometries are distorted

Engineering Contradiction:

Improveattachment firmnessVSAvoidleaflet geometry

Core Design Contradiction:

StrengthVSShape

Solution Approach 1:

The patent replaces the tension-based suture system with a mechanical interlocking system where leaflet frame projections extend through apertures and are retained by restraining members. This substitution eliminates the need for high tension application, thereby securing leaflets firmly while preserving their natural local geometries and preventing distortion.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

Data Source

PatentEP3718510A1Prosthetic valves with mechanically coupled leaflets

Publication Date: 2020.10.07 EDWARDS LIFESCIENCES CORP

Figure 1A~1B
Figure 1C
Figure 2A~2B

AI summary

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices (100) having a leaflet frame (200) and a mechanically coupled leaflet (310). 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.