Pericardium Prosthetic Heart Valve Stent Integration
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Solution Overview
Problem
Existing prosthetic heart valves face issues with durability, reverse blood flow prevention, and secure attachment to wire stents, leading to potential tearing and functionality loss due to prolonged use and blood pressure.
Innovation Solution
A prosthetic heart valve manufactured using quadrangular-shaped heterogeneous tissue pieces from bovine or porcine pericardium, folded and sewn to form valve and securing pieces, integrated with a wire stent using superelastic shape-memory alloy wires, ensuring secure attachment and preventing reverse blood flow.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Productivity
If traditional trilobate polymer valve manufacturing methods are used, then the valve can be fabricated with leaflets and conduit, but the production time is several days and quality consistency is poor due to manual labor
Solution Approach 1:
The patent combines the fabrication of valve leaflets and valve conduit into a single integrated structure. The pericardium is processed to create both components simultaneously, eliminating the need for separate fabrication and assembly steps. This merging of operations reduces production time from several days to a single continuous process while ensuring consistent quality through automated or semi-automated processing.
Solution Approach 2:
The pericardium is divided into specific segments or regions that are systematically processed. The valve leaflets and conduit are created from defined portions of the pericardium through controlled cutting, folding, and suturing operations. This segmentation approach allows for standardized processing steps that improve both productivity and manufacturing precision.
2Shape
If the valve conduit is made thin to match leaflet thickness, then the valve appears more natural, but the conduit lacks sufficient strength to withstand blood pressure and prolonged use
Solution Approach 1:
The patent applies different structural characteristics to different regions of the valve. The valve leaflets maintain a thin, flexible structure for natural appearance and function, while the valve conduit is constructed with increased thickness and reinforced with wire stent integration. This local differentiation allows each component to have the optimal properties for its specific function: thinness for the leaflets and strength for the conduit.
Solution Approach 2:
The valve conduit is created as a composite structure combining pericardium tissue with wire stent reinforcement. The wire stent provides the necessary structural strength and rigidity to withstand blood pressure, while the pericardium layer maintains biocompatibility and a natural appearance. This composite construction resolves the contradiction between thinness and strength.
3Strength
If the valve conduit is made thicker to increase strength, then the valve can withstand blood pressure, but the thickness becomes two to twenty times greater than the leaflets, creating an unnatural appearance
Solution Approach 1:
The patent applies different structural characteristics to different regions of the valve. The valve leaflets maintain a thin, flexible structure for natural appearance and function, while the valve conduit is constructed with increased thickness and reinforced with wire stent integration. This local differentiation allows each component to have the optimal properties for its specific function: thinness for the leaflets and strength for the conduit.
4Adaptability or versatility
If separate fabrication of leaflets and conduit is used, then each component can be optimized independently, but the manufacturing process requires multiple steps and manual assembly
Solution Approach 1:
The patent combines the fabrication of valve leaflets and valve conduit into a single integrated structure. The pericardium is processed to create both components simultaneously, eliminating the need for separate fabrication and assembly steps. This merging of operations reduces production time from several days to a single continuous process while ensuring consistent quality through automated or semi-automated processing.
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
The solution provides a durable and secure prosthetic heart valve that withstands blood pressure and prevents reverse blood flow, with improved manufacturing efficiency and reduced risk of tearing, enhancing the valve's longevity and functionality.
Implementation Method 1
preparing a wire stent by intertwining wires made of an superelastic shape-memory alloy
Implementation Method 2
wires made of an superelastic shape-memory alloy
Data Source
Figure 1(a)~1(b)
Figure 2(a)~2(b)
Figure 3
AI summary
A prosthetic heart valve using a pericardium is disclosed where: three hetero-biological tissue slices, which are extracted in a quadrangular shape from a bovine pericardium or a porcine pericardium, are prepared; each hetero-biological tissue slice is folded so as to form an inner tissue slice inside and an outer tissue slice outside, the outer tissue slice being longer than the inner tissue slice; each of the inner tissue slice and outer tissue slice is coupled by sewing in a semicircular shape with a first coupling thread such that each inner tissue slice forms a pulmonic valve slice inside the first coupling thread and a fixing slice outside the first coupling thread such that each hetero-biological tissue slice is formed in a cylindrical shape by allowing each slice to be adjacent to each other. The disclosed prosthetic heart valve has increased durability and prevents reverse blood flow.