Prosthetic Heart Valve Leaflet Attachment Durability

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Existing prosthetic heart valves with flexible leaflets face durability issues due to repetitive loads during opening and closing, leading to mechanical failure at the mounting edge, especially with synthetic leaflets.

Innovation Solution

A prosthetic valve design featuring a leaflet frame with commissure posts and a leaflet construct with bridge regions and fold-over portions, where the leaflet construct extends through post slots in the leaflet frame and is secured by an outer frame and a securement structure.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If individual leaflets are sewn to the frame using traditional fabrication techniques, then the valve can be manufactured with flexible leaflets, but the repetitive loads during opening and closing cause mechanical failure at the mounting edge

Engineering Contradiction:

Improvevalve durabilityVSAvoidmounting edge strength

Core Design Contradiction:

ReliabilityVSStrength

Solution Approach 1:

The leaflet construct is segmented into multiple leaflets with bridge regions connecting them, allowing the load to be distributed across multiple attachment points on the frame rather than concentrated at single mounting edges. This segmentation reduces stress at any single location while maintaining overall structural integrity.

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

A securement structure acts as an intermediary element between the leaflet construct and the frame, providing a transition zone that distributes loads. The securement structure includes mounting features that spread the attachment forces across a larger area of the frame, reducing peak stresses at the mounting edge.

Inventive Principle:

Principle #24Intermediary (Mediator)

2Strength

If synthetic leaflet material is used to improve durability, then the leaflet can resist wear better, but stress concentrations at the mounting edge still lead to mechanical failure

Engineering Contradiction:

Improveleaflet material strengthVSAvoidstress concentration at mounting edge

Core Design Contradiction:

StrengthVSStress or pressure

Solution Approach 1:

The design applies local quality by providing enhanced support and load distribution specifically at the mounting edge region through the securement structure, while the leaflet material itself maintains its synthetic properties for overall durability. The securement structure creates a localized zone of improved stress management at the critical mounting interface.

Inventive Principle:

Principle #3Local quality

3Stability of the object's composition

If the leaflet is supported on the frame with a rigid mounting edge, then the leaflet can be securely attached, but the rigid support creates stress concentrations that lead to fatigue failure

Engineering Contradiction:

Improveleaflet attachment stabilityVSAvoidresistance to fatigue failure

Core Design Contradiction:

Stability of the object's compositionVSReliability

Solution Approach 1:

The securement structure introduces dynamic characteristics to the mounting system, allowing for controlled movement and stress distribution rather than rigid fixed attachment. This dynamic approach enables the mounting system to adapt to varying loads during valve operation, reducing fatigue accumulation.

Inventive Principle:

Principle #15Dynamics

Data Source

PatentUS20250114193A1Prosthetic heart valve

Publication Date: 2025.04.10 EDWARDS LIFESCIENCES CORP

AI summary

Described embodiments are directed toward centrally-opening leaflet prosthetic valve devices having a leaflet frame and a leaflet construct including one or more leaflets. In some examples, the leaflet construct is coupled to the leaflet frame via a retention element. In some examples, the retention element is in the form of an outer frame that is coaxially arranged with the leaflet frame.