Prosthetic Valved Conduit Leaflet Coupling Without Sutures

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Solution Overview

Problem

Existing prosthetic valves with flexible leaflets face issues with securing leaflets to a support structure, such as through suturing or adhesive/thermal bonding, which can affect the integrity and functionality over time, especially in aqueous environments.

Innovation Solution

Mechanically coupling leaflets to a leaflet frame using leaflet frame projections that extend through apertures in the leaflet attachment region, with restraining elements to prevent decoupling, eliminating the need for suturing or adhesive bonding.

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 processVSAvoidbond integrity
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent replaces chemical bonding (adhesive) with a mechanical interlocking system consisting of protrusions on the support structure that engage with recesses in the leaflet tissue. This mechanical coupling method provides reliable long-term attachment in aqueous environments while maintaining manufacturing simplicity, directly resolving the contradiction between ease of manufacture and bond integrity.

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
Core Design Contradiction:
StrengthVSDevice complexity

Solution Approach 1:

The patent employs a self-aligning mechanical interlocking system where the protrusions and recesses automatically engage with each other during assembly, eliminating the need for complex suturing procedures. The geometric complementarity of the coupling elements ensures proper alignment and secure attachment without requiring skilled manual intervention, thus maintaining attachment strength while reducing manufacturing complexity.

Inventive Principle:
Principle #25Self-service

3Ease of manufacture

If adhesive bonding is used to secure leaflets, then the manufacturing process is simplified, but the functional performance deteriorates due to poor tension control

Engineering Contradiction:
Improveattachment processVSAvoidfunctional performance
Core Design Contradiction:
Ease of manufactureVSEase of operation

Solution Approach 1:

The patent distributes multiple protrusions across the attachment surface, with each protrusion engaging a corresponding recess in the leaflet tissue. This distributed mechanical coupling allows for localized tension control at each engagement point, ensuring uniform stress distribution and optimal functional performance while maintaining manufacturing simplicity through the repetitive modular design.

Inventive Principle:
Principle #3Local quality

Data Source

PatentUS20250381030A1Prosthetic valved conduits with mechanically coupled leaflets
Publication Date: 2025.12.18 EDWARDS LIFESCIENCES CORP
  • US20250381030A1 patent drawing
  • US20250381030A1 patent drawing
  • US20250381030A1 patent drawing

AI summary

A prosthetic heart valve comprising a radially expandable and compressible frame and a plurality of leaflets is disclosed. The frame comprises a plurality of rows of angled frame elements and a plurality of axially extending commissure support portions spaced apart from each other around a circumference of the frame and defining first and second slots. The plurality of leaflets each comprise a leaflet attachment region defining opposing attachment portions on opposite sides of the leaflet. At each commissure support portion of the frame, an attachment portion of one of the leaflets extends through the first slot and an attachment portion of an adjacent leaflet extends through the second slot.