Heparin Bioactive Matrix for Blood-Contacting Surfaces

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Solution Overview

Problem

Current medical devices, such as blood oxygenators and catheters, face challenges in achieving biocompatibility and blood compatibility while maintaining gas permeability, as surface coatings often leach or attract phospholipids, reducing their effectiveness in gas transfer and stability.

Innovation Solution

A method involving surface activation through plasma or gas treatment, followed by wet chemistry processes using strong oxidizing agents and cationic polymers to covalently immobilize heparin on blood-contacting surfaces, creating an engineered bioactive matrix that enhances biocompatibility and stability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If surface coatings are applied to improve biocompatibility and blood compatibility, then adverse reactions are reduced, but the coatings leach or strip off over time, reducing stability and effectiveness

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidcoating stability
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary surface activation treatments (plasma, gas, or chemical) to the substrate before coating application. This creates a pre-conditioned surface with enhanced reactivity and bonding capacity, ensuring that the subsequent heparin coating adheres strongly and remains stable over time, preventing leaching and stripping

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The patent modifies surface parameters through activation treatments that change the surface energy, roughness, and chemical composition. These parameter changes create optimal surface conditions for strong covalent bonding with heparin, ensuring both biocompatibility and long-term stability without coating degradation

Inventive Principle:
Principle #35Parameter changes

2Reliability

If phospholipids are used as coating materials to improve biocompatibility, then blood compatibility is enhanced, but phospholipids attract and adhere to surfaces, coating pores and wetting the surface, which reduces gas transfer efficiency

Engineering Contradiction:
Improveblood compatibilityVSAvoidgas transfer efficiency
Core Design Contradiction:
ReliabilityVSProductivity

Solution Approach 1:

The patent extracts or removes phospholipids from the coating composition entirely, replacing them with heparin as the active anticoagulant agent. This eliminates the harmful effect of phospholipid adsorption and surface wetting while maintaining blood compatibility through heparin's anticoagulant properties

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The patent uses a spacer molecule as an intermediary between the substrate and heparin coating. This spacer layer provides optimal spacing and orientation for heparin molecules, ensuring blood compatibility while preventing excessive surface wetting and maintaining gas transfer efficiency through the membrane pores

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 engineered heparin bioactive matrix improves biocompatibility and stability, maintaining physiologically significant bioactivity over time, reducing adverse reactions and improving gas exchange efficiency in medical devices.

Implementation Method 1

activating a blood contacting surface of at least one component of a medical device via one of plasma treatment or gas activation

Methodology Applied
Scientific EffectPlasma treatment: Plasma

Implementation Method 2

enhancing at least the blood contacting surface with a wet chemistry treatment including an aqueous solution having a strong oxidizing agent, such as ammonium persulfate

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 3

adding a positively charged spacer molecule to at least the blood contacting surface with a wet chemistry treatment including an aqueous solution having a cationic polymer, such as PEI

Methodology Applied
Scientific EffectElectrostatic interaction: Electrostatics

Implementation Method 4

covalently immobilizing heparin to at least the blood contacting surface with a wet chemistry treatment including heparin

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Data Source

PatentUS20240307593A1Engineered heparin bioactive matrix for clinical application of blood contacting surface and method of manufacturing the same
Publication Date: 2024.09.19 ENSION
  • US20240307593A1 patent drawing

AI summary

A manufacturing method fora pipeline flow diverter or stent includes activating a blood-contacting metal surface of the medical device via i) propene plasma treatment or ii) contacting the surface with an organic solution comprising a silane functional compound having an ethylenically unsaturated functional group, wherein the organic solution follows a blood flow path through the medical device; grafting a polymeric hydrogel to the activated surface; bonding a positively charged spacer molecule to the polymeric hydrogel by contacting the polymeric hydrogel with a first wet chemistry treatment composition comprising an aqueous solution containing a cationic polymer, wherein the first wet chemistry treatment follows a blood flow path through the medical device; and covalently bonding heparin to the spacer molecule by contacting the spacer molecule with a second wet chemistry treatment composition comprising heparin, wherein the second wet chemistry treatment follows a blood flow path through the medical device.