Prosthetic Heart Valve Leaflet Planar Zone Stress Reduction

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Solution Overview

Problem

Prosthetic heart valve leaflets made from synthetic materials face durability issues due to repetitive loading, leading to mechanical failure at the mounting edge and high stress zones, which can cause holes and tears, especially when modeled after native human valves without considering the unique properties of synthetic materials.

Innovation Solution

The design features flexible leaflets with a planar central zone, specifically a truncated isosceles triangle or isosceles trapezoid shape, to minimize stress and buckling, using a composite material of expanded fluoropolymer membrane combined with an elastomer, and a redundant coaptation zone for full coaptation and reduced crease formation.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Shape

If synthetic leaflets are modeled after native human valve shapes, then the valve can achieve natural flow patterns, but the leaflets experience high stress concentrations at the mounting edge leading to mechanical failure

Engineering Contradiction:
Improvevalve leaflet shapeVSAvoidleaflet durability
Core Design Contradiction:
ShapeVSReliability

Solution Approach 1:

The patent applies local quality by creating a planar zone specifically at the mounting edge of the leaflet, while the rest of the leaflet maintains the native valve shape. This localized modification concentrates the beneficial properties where stress is highest (at the mounting edge) without sacrificing the overall natural flow patterns provided by the native-shaped leaflet geometry

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The leaflet is segmented into distinct zones: a planar zone at the mounting edge and a native-shaped zone for the main body. This segmentation allows each zone to serve its specific function - the planar zone handles stress concentration while the native-shaped zone maintains natural flow patterns

Inventive Principle:
Principle #1Segmentation

2Shape

If the leaflet has small radius bends and creases to follow native valve geometry, then the valve achieves natural hemodynamics, but high stress zones form causing holes and tears under repetitive loading

Engineering Contradiction:
Improveleaflet geometryVSAvoidleaflet material strength
Core Design Contradiction:
ShapeVSStrength

Solution Approach 1:

The patent introduces a planar zone at the mounting edge where stress concentration occurs, while allowing the rest of the leaflet to maintain the native valve geometry with its characteristic bends and creases. This localized planar region eliminates high stress concentrations without compromising the overall natural hemodynamic performance

Inventive Principle:
Principle #3Local quality

3Stability of the object's composition

If the leaflet mounting edge is made rigid to support the leaflet structure, then the leaflet maintains its shape, but stress concentrates at the mounting edge leading to fatigue failure

Engineering Contradiction:
Improveleaflet structural stabilityVSAvoidmounting edge durability
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent uses a planar zone configuration that provides structural stability through its geometry rather than material rigidity. The planar zone distributes loads evenly across the mounting edge, allowing the leaflet to maintain its shape while avoiding stress concentrations that would lead to fatigue failure in rigid structures

Inventive Principle:
Principle #30Flexible shells and thin films

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

This configuration reduces stress on the leaflets, enhances durability, and prevents prolapse and regurgitant flow, improving the longevity and performance of synthetic heart valves by distributing loads more evenly and reducing material fatigue.

Implementation Method 1

The durability of synthetic materials used for heart valve leaflets under the repetitive loads of the opening and closing is dependent, in part, on the load distribution between the leaflet and the frame

Methodology Applied
Scientific EffectStress distribution:

Implementation Method 2

The durability of the valve leaflets is also a function of the character of bending by the leaflet during the opening-closing cycle. Small radius bends, creases and intersecting creases, can produce high stress zones in the leaflet

Methodology Applied
Scientific EffectBuckling resistance:

Implementation Method 3

A coaptation height is defined as a length of the coaptation zone measured in an axial direction, wherein the coaptation height is greater than zero

Methodology Applied
Scientific EffectCoaptation:

Data Source

PatentUS20240058118A1Vertical coaptation zone in a planar portion of prosthetic heart valve leaflet
Publication Date: 2024.02.22 EDWARDS LIFESCIENCES CORP
  • US20240058118A1 patent drawing
  • US20240058118A1 patent drawing
  • US20240058118A1 patent drawing

AI summary

Described embodiments are directed toward prosthetic valve leaflets of a particular shape that allows redundant coaptation height in the leaflets when a planar segment is present in each leaflet.