Heat-Set Synthetic Valve Leaflets for Better Coaptation

Resolve Bottlenecks,
Find Innovative Solutions
Generate Solutions

Solution Overview

Problem

Existing prosthetic heart valves using synthetic materials face challenges with leaflet motion, coaptation, durability, and uniformity, leading to inefficiencies in blood flow and potential regurgitation.

Innovation Solution

Heat treating synthetic materials, such as ultra-high molecular weight polyethylene (UHMWPE), to shape and bias prosthetic leaflets into desired configurations, enhancing coaptation and motion through controlled three-dimensional geometry.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If synthetic materials are used for prosthetic leaflets, then sourcing and uniformity issues are addressed, but material properties affect valve function, motion and coaptation

Engineering Contradiction:
ImproveuniformityVSAvoidleaflet function
Core Design Contradiction:
Stability of the object's compositionVSReliability

Solution Approach 1:

The patent applies heat treatment to modify the physical and mechanical properties of synthetic polymer materials. By controlling temperature, time, and atmospheric parameters during heat treatment, the material achieves optimal flexibility, elasticity, and structural stability required for proper leaflet motion and coaptation while maintaining uniformity across production batches

Inventive Principle:
Principle #35Parameter changes

2Ease of operation

If traditional tissue leaflets are used, then natural motion is achieved, but calcification, stenosis, and sourcing issues occur

Engineering Contradiction:
Improveleaflet motionVSAvoidcalcification
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The patent employs synthetic polymer materials that can be mass-produced with consistent properties, replacing expensive and variable natural tissues. The heat treatment process further enhances the material's resistance to degradation and calcification, creating a durable alternative that maintains operational performance without the harmful effects associated with biological tissues

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

Solution Approach 2:

Through controlled heat treatment, the synthetic material's physical properties are optimized to achieve natural-like leaflet motion characteristics. The process adjusts molecular structure and mechanical properties to enable proper flexibility and elastic recovery, mimicking the dynamic behavior of natural tissue while avoiding its vulnerabilities

Inventive Principle:
Principle #35Parameter changes

3Manufacturing precision

If heat treating is applied to synthetic materials, then leaflet coaptation and motion are improved, but additional processing steps are required

Engineering Contradiction:
ImprovecoaptationVSAvoidprocessing steps
Core Design Contradiction:
Manufacturing precisionVSDevice complexity

Solution Approach 1:

The heat treatment process is integrated into the manufacturing workflow as a preliminary step that prepares the synthetic material with optimal properties before final assembly. This advance treatment ensures consistent coaptation and motion characteristics are built into the material itself, reducing the need for subsequent adjustments or modifications

Inventive Principle:
Principle #10Preliminary action

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

Improves leaflet coaptation and uniform opening, reducing gaps and regurgitation, thereby optimizing blood flow efficiency and durability of prosthetic heart valves.

Implementation Method 1

Heat treating synthetic materials, such as ultra-high molecular weight polyethylene (UHMWPE), to shape and bias prosthetic leaflets into desired configurations

Methodology Applied
Scientific EffectHeat treatment: Heat Treatment

Data Source

PatentEP4225214B1Heat treating to improve synthetic leaflet motion and coaptation
Publication Date: 2025.11.19 ST JUDE MEDICAL CARDILOGY DIV INC
  • EP4225214B1 patent drawingFigure 1
  • EP4225214B1 patent drawingFigure 2A~2B
  • EP4225214B1 patent drawingFigure 3A~3B

AI summary

A prosthetic heart valve includes a support structure and a valve assembly. The valve assembly includes a cuff and a plurality of leaflets, each of the prosthetic leaflets being composed of a synthetic material. The prosthetic leaflets have a closed condition in which the prosthetic leaflets coapt to restrict blood from flowing in a retrograde direction through the support structure and an open condition in which the prosthetic leaflets allow blood to flow in an antegrade direction through the structure. The synthetic material may be heat set to bias the leaflets to the open or closed condition, or to bias one portion of the leaflet to the open condition and another portion of the leaflet to the closed condition.