Prosthetic Valve Commissure Assembly for Stable Leaflet Attachment

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Solution Overview

Problem

Existing prosthetic heart valves face challenges in forming and securing commissures, which are prone to wear and deterioration due to complex suturing and stress from cyclical forces, leading to less robust attachments and potential displacement.

Innovation Solution

The formation of commissures involves folding commissure tabs of adjacent leaflets into overlapping layers perpendicular to the frame's axial and radial directions, secured to an attachment member that protrudes from the frame, reducing stress and improving longevity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional suturing methods are used to form commissures, then the commissures can be attached to the frame, but the attachment is subject to wear and deterioration from cyclical forces and stress

Engineering Contradiction:
Improveattachment durabilityVSAvoidcommissure longevity
Core Design Contradiction:
ReliabilityVSDuration of action of stationary object

Solution Approach 1:

A reinforcement member is introduced as an intermediary component between the commissure and the frame. The reinforcement member receives cyclical forces and stress, protecting the suture attachment points. The commissure is sutured to the reinforcement member rather than directly to the frame, creating a buffer that reduces wear on the primary attachment structure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The reinforcement member is pre-installed on the frame before commissure attachment. This protective structure is in place beforehand to absorb and distribute the cyclical forces and stress that will occur during valve operation, preventing direct transmission of these forces to the suture lines and commissure tabs.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

2Reliability

If commissure tabs are wrapped around the commissure support portion, then attachment is achieved, but displacement occurs including rotation and axial sliding

Engineering Contradiction:
Improveattachment stabilityVSAvoidcommissure position stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The reinforcement member serves as an intermediary structure that provides a stable, dedicated attachment surface for the commissure tabs. Instead of wrapping around the curved commissure support portion, the tabs attach to the reinforcement member which is positioned to provide optimal geometric stability, preventing rotation and axial sliding.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The reinforcement member is pre-positioned and secured to the frame at precise locations before commissure attachment. This preliminary action ensures that the commissure tabs have a fixed, stable reference point for attachment, eliminating the geometric uncertainties that lead to displacement during operation.

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If vertical folding of commissure tabs is used to form commissures, then the commissures can be attached, but the attachment becomes less robust

Engineering Contradiction:
Improvecommissure formationVSAvoidattachment robustness
Core Design Contradiction:
Ease of manufactureVSStrength

Solution Approach 1:

The reinforcement member provides a stable intermediate attachment surface that compensates for the reduced robustness of vertically folded commissure tabs. By attaching the folded tabs to this reinforced structure rather than directly to the frame, the overall attachment strength is enhanced despite the simplified folding configuration.

Inventive Principle:
Principle #24Intermediary (Mediator)

Data Source

PatentEP4125728B1Prosthetic heart valve leaflet commissure assemblies and method of assembling
Publication Date: 2026.04.08 EDWARDS LIFESCIENCES CORP
  • EP4125728B1 patent drawingFigure 1
  • EP4125728B1 patent drawingFigure 2
  • EP4125728B1 patent drawingFigure 3

AI summary

A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including an annular frame and a plurality of leaflets is disclosed. As one example, the valve includes a plurality of commissures, each commissure including an attachment member including a protruding portion, a first commissure tab of a first leaflet of the plurality of leaflets arranged adjacent to a first side of the protruding portion and secured directly to the attachment member. Each commissure further includes a second commissure tab of a second leaflet of the plurality of leaflets arranged adjacent to an opposite, second side of the protruding portion and secured directly to the attachment member.