Heat-Set Synthetic Valve Leaflets for Better Coaptation
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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
Engineering 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
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
2Ease of operation
If traditional tissue leaflets are used, then natural motion is achieved, but calcification, stenosis, and sourcing issues occur
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
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
3Manufacturing precision
If heat treating is applied to synthetic materials, then leaflet coaptation and motion are improved, but additional processing steps are required
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
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
Data Source
Figure 1
Figure 2A~2B
Figure 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.