Overlapping Leaflet Tabs for Durable Heart Valve Commissures

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Solution Overview

Problem

Existing prosthetic heart valve commissures are complex, time-consuming to assemble, prone to wear, and subject to deterioration due to non-uniform stresses during valve operation, leading to axial folds and displacement.

Innovation Solution

The commissures are formed by folding commissure tabs into overlapping layers and securing them within a commissure support element using reinforcement members, which are configured to maintain the commissure tabs against the frame, reducing wear and improving longevity.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If traditional commissure assembly methods are used with numerous stitches, then the commissure can be attached to the frame, but the assembly process becomes complex and time-consuming

Engineering Contradiction:

Improvecommissure attachment reliabilityVSAvoidcommissure assembly complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The commissure assembly is segmented into distinct functional components: the commissure support portion with window, the reinforcement member, and the leaflet tabs. This segmentation allows each component to be optimized independently and assembled in a standardized sequence, reducing overall complexity while maintaining attachment reliability

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The reinforcement member is pre-positioned within the commissure support portion before the leaflet tabs are attached. This preliminary action creates a pre-prepared attachment structure that guides the leaflet tabs into proper alignment and reduces the number of adjustment steps required during final assembly

Inventive Principle:

Principle #10Preliminary action

2Reliability

If traditional commissure assembly methods with numerous stitches are used, then the commissure can be secured to the frame, but the assembly process becomes time-consuming

Engineering Contradiction:

Improvecommissure attachment reliabilityVSAvoidcommissure assembly time

Core Design Contradiction:

ReliabilityVSLoss of time

Solution Approach 1:

Inventive Principle:

Principle #10Preliminary action

Solution Approach 2:

The reinforcement member serves multiple functions simultaneously: it reinforces the attachment point, guides leaflet tab alignment, and anchors the commissure to the frame. This merging of functions into a single component reduces the number of separate assembly steps required

Inventive Principle:

Principle #5Merging (Combining)

3Device complexity

If commissure tabs are attached directly to the frame without reinforcement, then the assembly is simpler, but the commissure is subject to wear and deterioration from non-uniform stresses

Engineering Contradiction:

Improvecommissure assembly complexityVSAvoidcommissure durability

Core Design Contradiction:

Device complexityVSReliability

Solution Approach 1:

The reinforcement member is strategically positioned at the commissure attachment point where non-uniform stresses occur during valve operation. This localized reinforcement provides enhanced durability precisely where needed, without adding complexity to other parts of the commissure structure

Inventive Principle:

Principle #3Local quality

Solution Approach 2:

The reinforcement member is installed in advance to cushion and distribute the non-uniform stresses that will occur during valve operation. This beforehand cushioning prevents wear and deterioration by absorbing and redistributing stress forces before they can damage the commissure tabs or frame attachment

Inventive Principle:

Principle #11Beforehand cushioning (Prior cushioning)

4Reliability

If traditional suture methods are used to attach commissures, then the commissure can be secured to the frame, but the sutures are subject to wear from contact with moving leaflet parts

Engineering Contradiction:

Improvecommissure attachment reliabilityVSAvoidsuture lifespan

Core Design Contradiction:

ReliabilityVSDuration of action of moving object

Solution Approach 1:

The reinforcement member acts as an intermediary between the moving leaflet tabs and the stationary frame attachment. It absorbs the wear and friction from leaflet movement, protecting the sutures from direct contact with moving parts and extending their operational lifespan while maintaining attachment reliability

Inventive Principle:

Principle #24Intermediary (Mediator)

Data Source

PatentUS12427013B2Prosthetic heart valve leaflet commissure assemblies and methods

Publication Date: 2025.09.30 EDWARDS LIFESCIENCES CORP

AI summary

A prosthetic heart valve and associated methods for assembling a prosthetic heart valve including a plurality of leaflets is disclosed. As one example, a prosthetic heart valve includes a frame; a plurality of commissure support elements, each connected the frame and including two axially-extending members spaced apart from one another to form a window; and a plurality of leaflets, each leaflet comprising a body and two opposing commissure tabs, each commissure tab arranged adjacent to another commissure tab to form a pair of commissure tabs that are disposed in a commissure support element to form a commissure. Each commissure tab includes a series of overlapping layers that include a first set of two overlapping layers that extends through the window and a second set of two overlapping layers that extends away from the first set of two overlapping layers and over an outer side of a corresponding axially-extending member.