Bioprosthetic Valve Material Blocking Residual Aldehydes
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Solution Overview
Problem
Existing valve materials for transcatheter replacement, particularly those cross-linked with glutaraldehyde, suffer from issues of calcification and clotting due to residual aldehyde groups, posing risks and reducing their service life, especially in complex hemodynamic environments like venous and pulmonary valves.
Innovation Solution
A four-step process involving glutaraldehyde crosslinking followed by immersion in a blocking solution of amino compounds, then treatment with anti-clotting agents and crosslinking agents, and finally washing, to block residual aldehyde groups and enhance anti-calcification and anti-clotting properties.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Duration of action of stationary object
If glutaraldehyde crosslinking is used to improve mechanical strength and service life, then the valve material gains enhanced durability, but residual aldehyde groups cause calcification and clotting
Solution Approach 1:
The patent removes the harmful residual aldehyde groups from the crosslinked valve material by immersing it in an amino compound solution. The amino groups react with and eliminate the residual aldehyde groups, thereby extracting the harmful substance while preserving the beneficial crosslinked structure that provides mechanical strength and service life.
Solution Approach 2:
The patent converts the harmful residual aldehyde groups into beneficial functional groups by reacting them with amino compounds. The residual aldehyde groups that cause calcification and clotting are transformed into amino-functionalized groups that provide anti-calcification and anti-thrombotic properties, turning a harmful feature into a beneficial one.
2Strength
If glutaraldehyde crosslinking is applied to enhance mechanical properties, then the valve material achieves sufficient strength, but cytotoxicity and thrombotic risk increase due to aldehyde residues
Solution Approach 1:
The patent extracts the cytotoxic and thrombotic harmful factors (residual aldehyde groups) from the mechanically strengthened valve material by chemical reaction with amino compounds. This removal process eliminates the reliability issues while maintaining the mechanical strength provided by the crosslinked structure.
Solution Approach 2:
The amino compound acts as an intermediary substance that mediates between the crosslinked valve material and the biological environment. It reacts with residual aldehyde groups to form stable amino-functionalized groups, thereby eliminating cytotoxicity and thrombotic risk while preserving the mechanical properties of the crosslinked material.
3Object-affected harmful factors
If new crosslinking methods are developed to replace glutaraldehyde, then anti-clotting properties may improve, but challenges in sterilization, detoxification and preservation arise
Solution Approach 1:
The patent performs preliminary detoxification by immersing the glutaraldehyde-crosslinked valve material in an amino compound solution before final sterilization and preservation. This preliminary action removes residual aldehyde groups that cause cytotoxicity and thrombotic risk, simplifying subsequent sterilization and preservation processes while maintaining anti-clotting properties.
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 modified valve materials exhibit improved anti-calcification and anti-clotting properties, extending their service life and ensuring better hemodynamic compatibility, as demonstrated by reduced thrombosis and calcification in tests.
Implementation Method 1
crosslinking an animal-derived biological valve material with glutaraldehyde
Implementation Method 2
immersing the valve material treated in step (1) into a blocking solution of amino compound
Implementation Method 3
placing the valve material treated in step (2) into a reaction solution containing an anti-clotting agent and a crosslinking agent
Data Source
AI summary
The present invention provides a valve material having synergistic anti-coagulation and anti-calcification functions and a preparation method therefor. The preparation method comprises the following steps: performing glutaraldehyde cross-linking treatment on an animal-derived biological valve material; immersing the treated valve material in a blocking solution containing an amine compound for 0.5-6 h, thereby blocking the remaining aldehyde groups after glutaraldehyde cross-linking; then placing the valve material into a reaction solution containing an anticoagulant and a cross-linking agent, and performing cross-linking treatment for 6-24 h at 4° C.-37° C.; and finally washing and obtaining the valve material, and storing the valve material in a mixed solvent of glutaraldehyde or isopropyl alcohol/glycerol. The method can effectively solve the problem of calcification and thrombosis caused by residual aldehyde groups in a valve material prepared by the existing method. The valve material prepared by the present method can be used as a valve material required for aortic valve, pulmonary valve, venous valve, mitral valve and tricuspid valve replacement.