Protective Coating for Immobilized Biologically Active Entities

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Solution Overview

Problem

Medical devices with biologically active entities face significant loss of biological activity due to sterilization, mechanical compaction, and storage conditions, which degrade the immobilized entities and reduce their effectiveness.

Innovation Solution

Incorporating biologically compatible organic compositions such as glycosaminoglycans, dextran, or dextran sulfate with immobilized biologically active entities like heparin on substrate materials, which helps maintain their activity during sterilization, mechanical manipulation, and storage by preventing conformational changes and interactions that diminish biological function.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If sterilization, mechanical compaction, and storage are performed on immobilized biologically active entities, then the medical device can be used safely and stored long-term, but the biological activity of the entities is significantly degraded

Engineering Contradiction:
Improvebiological activity retentionVSAvoiddegradation from sterilization and mechanical stress
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A protective coating layer is applied to the substrate material before immobilizing the biologically active entities. This coating serves as a cushioning barrier that protects the entities from degradation during subsequent sterilization, mechanical compaction, and storage processes, allowing them to maintain biological activity while withstanding these harsh conditions

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

Solution Approach 2:

The invention uses a composite structure consisting of a substrate material, a protective coating material layered on the substrate, and biologically active entities immobilized on the coating. This multi-layer composite architecture combines the mechanical properties of the substrate, the protective properties of the coating, and the biological functionality of the entities, resolving the contradiction between durability and biological activity retention

Inventive Principle:
Principle #40Composite materials

2Ease of manufacture

If conventional immobilization methods are used on standard substrate materials, then the device structure is simple and manufacturing is easy, but the biological activity is lost during processing and storage

Engineering Contradiction:
Improveimmobilization process simplicityVSAvoidbiological activity maintenance
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The protective coating material is applied to the substrate material before the biologically active entities are immobilized. This preliminary action prepares the substrate with a protective barrier that will preserve biological activity during subsequent processing steps, combining ease of manufacture with reliability

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The invention changes the physical and chemical parameters of the substrate surface by applying a coating material with specific properties (porosity, chemical composition, mechanical characteristics). This parameter change enables the substrate to protect biological entities while maintaining ease of manufacturing through established coating techniques

Inventive Principle:
Principle #35Parameter changes

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 use of these compositions ensures that biologically active entities retain a significant degree of their anti-thrombin III binding activity, even after exposure to conditions that would otherwise degrade them, thereby maintaining the medical device's effectiveness.

Implementation Method 1

the biological activity of many of biologics is dependent on the conformation (i.e., primary, secondary, tertiary, etc.) of the biologic in its immobilized state

Methodology Applied
Scientific EffectConformational stability:

Implementation Method 2

Modification of the chemical composition of a substrate material is often required to immobilize a biologically active entity thereon. This is usually accomplished by treating surfaces of the substrate material to generate a population of chemically reactive elements or groups

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Data Source

PatentEP2023967B1Immobilized biologically active entities having a high degree of biological activity following mecanical manipulation or sterilization
Publication Date: 2017.03.22 WL GORE & ASSOC INC
  • EP2023967B1 patent drawingFigure 1~2
  • EP2023967B1 patent drawingFigure 3~4A
  • EP2023967B1 patent drawingFigure 5~6A

AI summary

The present invention relates to immobilized biologically active entities that retain significant biological activity following mechanical manipulation of a substrate material to which the entities are immobilized. The significant biological activity is retained through the contact of the coating material and the biologically active entities with a biologically compatible composition