Hyperbranched Polyglycerol Coating on Metallic Stents

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Solution Overview

Problem

Medical devices, particularly stents, suffer from fouling and thrombosis issues due to platelet adhesion and activation, leading to reduced longevity and increased risk of complications such as myocardial infarction and death.

Innovation Solution

A method of coating metallic substrates with a hyperbranched polyglycerol layer formed through plasma treatment and polymerization of glycidol monomers, which reduces platelet binding and activation, thereby minimizing fouling and thrombosis.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If metal/metal alloy stents are used, then effective treatment of narrowed or blocked arteries is achieved, but stent thrombosis risk increases due to platelet adhesion and activation

Engineering Contradiction:
Improvetreatment effectivenessVSAvoidplatelet adhesion and activation
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A hyperbranched polyglycerol coating is applied as an intermediary layer between the metal stent surface and the blood/platelets. This coating acts as a mediator that prevents direct contact and interaction between the metallic substrate and platelets, thereby reducing platelet adhesion and activation while maintaining the stent's structural function

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The hyperbranched polyglycerol coating creates an inert biochemical environment on the stent surface that is non-reactive to platelets and blood components. This inert surface layer prevents the harmful biochemical interactions that would otherwise occur between the reactive metal surface and blood elements

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

2Reliability

If metal stents are implanted, then arterial patency is improved, but fouling and protein accumulation occur on the device surface

Engineering Contradiction:
Improvearterial patencyVSAvoidfouling and protein accumulation
Core Design Contradiction:
ReliabilityVSObject-generated harmful factors

Solution Approach 1:

The hyperbranched polyglycerol coating serves as an intermediary barrier between the stent surface and biological fluids, preventing proteins and other fouling agents from adhering to the metal substrate while allowing the stent to perform its arterial support function

Inventive Principle:
Principle #24Intermediary (Mediator)

3Reliability

If anti-platelet therapy is prescribed, then stent thrombosis risk is reduced, but patient compliance and treatment complexity increase

Engineering Contradiction:
Improvethrombosis preventionVSAvoidtherapy regimen complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The stent coating provides self-service anti-thrombotic protection through its inherent anti-platelet properties. The hyperbranched polyglycerol layer actively prevents platelet adhesion and activation without requiring external pharmacological intervention, making the device itself responsible for thrombosis prevention

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The anti-thrombotic protection is built into the stent structure before implantation through the pre-applied hyperbranched polyglycerol coating. This preliminary action ensures that the anti-platelet effect is present from the moment of implantation, eliminating the need for subsequent therapeutic intervention

Inventive Principle:
Principle #10Preliminary action

4Adaptability or versatility

If stents are made from flexible metal alloys, then mechanical adaptability to arteries is improved, but thrombotic properties worsen due to metal surface reactivity

Engineering Contradiction:
Improvemechanical adaptabilityVSAvoidthrombotic properties
Core Design Contradiction:
Adaptability or versatilityVSObject-affected harmful factors

Solution Approach 1:

The stent structure maintains flexible metal alloy properties in its bulk form for mechanical adaptability, while the surface is locally modified with a hyperbranched polyglycerol coating that provides anti-thrombotic properties. This local quality differentiation allows the stent to have different properties in different locations: flexibility and strength in the bulk, and biocompatibility on the surface

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The stent becomes a composite structure combining flexible metal alloy material with a hyperbranched polyglycerol coating layer. This composite construction integrates the mechanical advantages of metal alloys with the biocompatibility and anti-thrombotic properties of the polymer coating

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 hyperbranched polyglycerol coating significantly reduces platelet attachment and activation, leading to a substantial decrease in fouling and thrombosis, potentially extending the lifespan of medical devices and reducing clinical complications.

Implementation Method 1

activating the metallic substrate by plasma treatment

Methodology Applied
Scientific EffectPlasma treatment: Plasma

Implementation Method 2

coating the activated metallic substrate with a hyperbranched polyglycerol by exposing the activated metallic substrate to substantially pure glycidol or a solution comprising at least 90% glycidol, and thereby forming the coating on the metallic substrate by polymerisation of glycidol monomers

Methodology Applied
Scientific EffectPolymerization: Photopolymerisation

Data Source

PatentEP3429651B1Anti-fouling and/or Anti-thrombotic medical devices
Publication Date: 2022.12.21 TEKCYTE LTD
  • EP3429651B1 patent drawingFigure 1A~1B
  • EP3429651B1 patent drawingFigure 2A~2B
  • EP3429651B1 patent drawingFigure 3A~3B

AI summary

The present disclosure relates to anti-fouling and/or anti-thrombotic medical devices, methods for reducing fouling and/or thrombosis associated with medical devices, and methods for coating substrates to reduce fouling and/or thrombosis. Certain embodiments of the present disclosure provide an anti-fouling and/or anti-thrombotic medical device comprising a metallic substrate comprising a hyperbranched polyglycerol coating.