Biological Valve Material with Phosphocholine Modification for Antithrombosis

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Solution Overview

Problem

Current valve materials used in heart valve replacements, particularly those cross-linked with glutaraldehyde, face issues with calcification and clotting due to their blood compatibility limitations, especially in complex hemodynamic environments like pulmonary and venous valves.

Innovation Solution

A method involving cross-linking animal-derived biological valve materials with glutaraldehyde, followed by immersion in a formulated solution containing a cross-linking agent and modifier, and heat treatment to create a valve material with long-acting antithrombosis properties, which blocks residual aldehyde groups and introduces phosphocholine components for improved anti-calcification and anti-clotting performance.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Stability of the object's composition

If glutaraldehyde cross-linking is used to improve mechanical properties and preservation performance, then valve material stability is improved, but blood compatibility deteriorates leading to calcification and clotting

Engineering Contradiction:

Improvevalve material stabilityVSAvoidcalcification and clotting

Core Design Contradiction:

Stability of the object's compositionVSObject-affected harmful factors

Solution Approach 1:

The patent introduces phosphocholine compounds as intermediary substances that react with residual aldehyde groups on the glutaraldehyde cross-linked valve surface. This intermediary reaction blocks the harmful interaction between aldehyde groups and blood components, thereby preventing calcification and clotting while preserving the mechanical stability provided by glutaraldehyde cross-linking.

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent converts the harmful residual aldehyde groups left after glutaraldehyde cross-linking into beneficial phosphocholine-modified groups. The aldehyde groups that would normally promote calcification and clotting are instead reacted with phosphocholine compounds to form stable phosphocholine cross-links, transforming the harmful residual groups into beneficial anti-thrombotic and anti-calcification sites.

Inventive Principle:

Principle #22Blessing in disguise (Convert harm into benefit)

2Reliability

If glutaraldehyde cross-linking is used to achieve detoxification and sterilization, then valve material safety is improved, but long-acting antithrombosis property deteriorates

Engineering Contradiction:

Improvevalve material safetyVSAvoidantithrombosis duration

Core Design Contradiction:

ReliabilityVSDuration of action of stationary object

Solution Approach 1:

The patent extends the antithrombosis duration by continuously blocking residual aldehyde groups with phosphocholine compounds throughout the valve material structure. This continuous modification ensures long-lasting prevention of thrombus formation, maintaining antithrombosis activity over the entire service life of the valve implant.

Inventive Principle:

Principle #20Continuity of useful action

Solution Approach 2:

The patent creates a composite modified valve material combining glutaraldehyde cross-linked biological valve substrate with phosphocholine compound modifications. This composite structure integrates the safety benefits of glutaraldehyde cross-linking (detoxification, sterilization, mechanical stability) with the long-acting antithrombosis properties of phosphocholine modifications.

Inventive Principle:

Principle #40Composite materials

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 enhanced anti-calcification and anti-clotting properties, reducing thrombosis and calcification risks, thereby improving their suitability for long-term use in heart valve replacements.

Implementation Method 1

Crosslinking an animal-derived biological valve material with glutaraldehyde

Methodology Applied

Scientific EffectCross-linking: Chemical Bonding

Implementation Method 2

blocks residual aldehyde groups and introduces phosphocholine components

Methodology Applied

Scientific EffectChemical reaction blocking: Chemical Bonding

Implementation Method 3

heating to 30-60° C. for heat treatment for 1-12 h

Methodology Applied

Scientific EffectHeat treatment: Heat Treatment

Data Source

PatentUS20230347016A1Valve material with long-acting antithrombosis property and preparation method therefor

Publication Date: 2023.11.02 VENUS MEDTECH (HANGZHOU) INC

AI summary

The present invention provides a valve material having a long-acting antithrombosis property and a preparation method therefor. The preparation method therefor comprises the following steps: performing glutaraldehyde cross-linking treatment on an animal-derived biological valve material, so that the valve material can resist decomposition for a long time; soaking the treated valve material in a formulation solution containing a cross-linking agent and a modifier for 10-60 min, then increasing the temperature to 30-60° C., and performing heat treatment for 1-12 h; and rinsing the valve material after heat treatment, so as to obtain the valve material. The valve material prepared by the method has excellent antithrombosis and anti-calcification properties, and can effectively solve the problem of calcification and thrombosis in the valve material treated by existing means of glutaraldehyde cross-linking. 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.