Two-Layer Woven Fabric Prosthetic Valve Leaflet Assembly
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Solution Overview
Problem
Current methods for manufacturing prosthetic heart valves face challenges in durability and efficiency, particularly in mimicking the natural valve's mechanical stresses and coaptation properties, leading to issues with valve longevity and regurgitation.
Innovation Solution
A method involving a two-layer woven fabric with selvedges forming the free margin of the leaflet, where the fabric is woven to create a tubular structure with interconnected layers, allowing for a single-piece construction of the leaflet and supporting element, enhancing durability and reducing process variability.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Ease of operation
If bioprosthetic valves with chemically treated bovine pericardium are used, then the valve can mimic natural valve properties, but early failure occurs due to high stresses on the leaflet material during continuous stretching and retracting
Solution Approach 1:
The patent combines synthetic polymer materials (such as polytetrafluoroethylene or polyurethane) with structural designs that incorporate stress-distribution elements. This composite approach replaces biological tissue with synthetic materials that have superior mechanical strength and fatigue resistance, while maintaining the natural valve's functional properties through careful material selection and structural configuration.
Solution Approach 2:
The patent modifies the mechanical parameters of the leaflet material by using synthetic polymers with controlled elasticity, tensile strength, and fatigue resistance. By changing the material parameters from biological tissue to engineered synthetic materials, the valve achieves both natural-like operation and enhanced durability against cyclic mechanical stresses.
2Ease of manufacture
If multiple separate components are assembled to form the prosthetic valve, then manufacturing flexibility is improved, but production anomalies and variability increase
Solution Approach 1:
The patent integrates the leaflet and supporting element into a single-piece constructed component. This merging of previously separate parts eliminates assembly steps, reduces production variability, and ensures consistent mechanical properties throughout the structure. The single-piece construction is achieved through molding or knitting processes that create the complete valve component in one manufacturing operation.
Solution Approach 2:
The single-piece constructed component serves multiple functions simultaneously - the leaflet provides valve closure while the integrated supporting element provides structural support and attachment functionality. This multi-functionality in a single component reduces the number of parts, simplifies manufacturing, and eliminates variability introduced by assembling multiple separate components.
3Ease of manufacture
If traditional valve designs are used, then existing manufacturing processes can be maintained, but mechanical stability and coaptation properties are insufficient
Solution Approach 1:
The patent changes the material parameters from traditional biological tissues to synthetic polymers with superior mechanical properties. These parameter changes include increased tensile strength, improved elasticity control, and enhanced fatigue resistance, while maintaining compatibility with modern manufacturing processes such as molding and knitting.
Solution Approach 2:
The patent employs composite material structures that combine different synthetic polymer properties to achieve optimal mechanical stability. The leaflet material is engineered with specific elastic and tensile characteristics, while the integrated supporting element provides complementary structural reinforcement, creating a composite system that exceeds the performance of traditional single-material designs.
Data Source
AI summary
The present invention provides a method of making a leaflet assembly, the leaflet assembly thus made and a prosthetic valve. The leaflet assembly can take a first form wherein the valve is open and a second form wherein the valve is closed, the valve comprising a leaflet assembly having at least one leaflet attached to a supporting element, the leaflet having a free margin that can move between a first position wherein the valve takes the first form and a second position wherein the valve takes the second form, the method comprising providing a textile structure, and forming the leaflet assembly from the textile structure, such that a selvedge of the textile structure forms the free margin of the leaflet, wherein the textile structure is made by weaving warp and fill threads into a two-layer woven fabric having two stacked and interconnected layers, the two layers having selvedges at one longitudinal edge, and wherein forming the leaflet assembly comprises connecting two lateral edges of a single piece of the fabric to make a substantially tubular structure wherein the inner layer forms the leaflet and the outer layer forms the supporting element. With this method a prosthetic valve can be made with little process variability and errors, and resulting in a valve with high reliability and durability.