Edge-Rigidized Biological Valve Crosslinking

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Solution Overview

Problem

Current artificial biological valves face issues such as tissue damage during stent compression and expansion, calcification, and edge vulnerability, leading to reduced durability and hemodynamic inefficiencies, which complicates implantation and requires surgical replacement if issues arise.

Innovation Solution

A method involving pretreatment of artificial biological valves with a glutaraldehyde solution followed by a reducing agent and tannin extract to enhance cross-linking of collagen, improving structural strength and calcification resistance, and including a sulfite to enhance solubility and interface performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If the balloon is expanded to fix the valve, then the valve is securely fixed, but the leaflet tissue structure suffers great damage

Engineering Contradiction:
Improvevalve fixation stabilityVSAvoidleaflet tissue structure
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The patent applies preliminary crosslinking treatment to the pericardial material before valve assembly and implantation. This pre-treatment strengthens the tissue structure in advance, making it more resistant to the mechanical damage that occurs during subsequent balloon expansion and fixation processes

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent creates a composite structure by crosslinking pericardial layers with collagen matrix. This composite material combines the advantages of both materials - the structural integrity of pericardium with the tensile strength and flexibility of collagen - resulting in a valve that can withstand balloon expansion without severe tissue damage

Inventive Principle:
Principle #40Composite materials

2Reliability

If the stent size is increased to prevent loosening, then valve stability improves, but the risk of tearing the aortic annulus increases

Engineering Contradiction:
Improvevalve stabilityVSAvoidaortic annulus damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent modifies the mechanical parameters of the pericardial material through crosslinking, changing its elasticity and strength characteristics. This allows the valve to achieve adequate stability with a smaller, safer stent size that won't tear the aortic annulus, while the crosslinked material compensates for the reduced mechanical support

Inventive Principle:
Principle #35Parameter changes

3Ease of manufacture

If the edge of the artificial biological valve is left untreated, then the manufacturing process is simple, but the edge is vulnerable to calcification and damage

Engineering Contradiction:
Improvemanufacturing simplicityVSAvoidedge resistance to calcification
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The patent applies crosslinking treatment specifically to the edge regions of the pericardial material, creating local quality enhancement where it is most needed. The edges receive higher concentration or longer duration crosslinking treatment compared to the central portions, providing targeted calcification resistance without requiring complete treatment of the entire valve structure

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent uses crosslinking agents as intermediary substances that facilitate the bonding between pericardial collagen fibers at the edges. These agents act as mediators that create strong intermolecular bonds, forming a protective barrier that resists calcification and mechanical damage while maintaining biocompatibility

Inventive Principle:
Principle #24Intermediary (Mediator)

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 method results in enhanced edge rigidity, improved mechanical properties, and increased durability of the artificial biological valve, reducing calcification and edge damage, thereby extending its service life and stability.

Implementation Method 1

collagen fibers in an artificial biological valve are treated with genipin and compared with those treated by the traditional glutaraldehyde method

Methodology Applied
Scientific EffectCross-linking: Chemical Bonding

Implementation Method 2

blocking the free aldehyde groups, carboxyl groups, amino groups, hydroxyl groups and carbonyl groups formed on the artificial biological valve pretreated with glutaraldehyde by a reducing agent and tannin extract

Methodology Applied
Scientific EffectChemical reaction: Chemical Bonding

Implementation Method 3

including a sulfite to enhance solubility and interface performance

Methodology Applied
Scientific EffectSolubility enhancement: Solvation

Data Source

PatentEP2774630B1Method for preparing edge-rigidized artificial biological valve
Publication Date: 2017.07.05 SHANGHAI MICROPORT CARDIOFLOW MEDTECH CO LTD
  • EP2774630B1 patent drawingFigure 1

AI summary

A method for preparing an edge-rigidized artificial biological valve comprising: first soaking an artificial biological valve in a pretreated glutaraldehyde solution, wherein the artificial biological valve can be partly fixed with glutaraldehyde before, after or during contact with the pretreated glutaraldehyde solution; and then closing the free aldehyde groups, carboxyl groups, amino groups, hydroxyl groups and carbonyl groups formed by the artificial biological valve pretreated with glutaraldehyde with a reducing agent and tannin extract. The edge rigidity of the artificial biological valve is enhanced, so that the long-term stability and durability of the artificial biological valve are improved.