Adhesion Promoting Base Layer for Lubricious Medical Coatings

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Solution Overview

Problem

Current lubricious coatings for medical devices face challenges in maintaining adhesion to hydrophobic substrates like polypropylene, FEP, and ETFE, leading to poor durability and high particulate release, which can be dangerous during procedures like angioplasty and stent placement.

Innovation Solution

A lubricious coating comprising a base coating layer with a polymeric adhesion promoter and a crosslinked polymeric matrix, and a top lubricious layer formed by curing a hydrophilic curable polymer with a crosslinking agent, providing strong adhesion and minimizing particulate release.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a hydrophilic polymer coating is applied to hydrophobic substrates (PP, FEP, ETFE), then lubricious performance is improved, but adhesion is poor and coating durability deteriorates

Engineering Contradiction:
Improvelubricious performanceVSAvoidadhesion and coating durability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The coating is divided into two distinct layers: a base layer containing hydrophobic polymer and adhesion promoter applied first, followed by a top layer containing hydrophilic polymer for lubricious performance. This segmentation allows each layer to perform its specialized function without compromising the other, solving the adhesion-lubrication conflict.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

An adhesion promoter component acts as an intermediary between the hydrophobic substrate and the hydrophilic top layer. This intermediary contains both hydrophobic groups (for substrate bonding) and hydrophilic groups (for top layer bonding), enabling strong interfacial adhesion across the hydrophobic-hydrophilic boundary.

Inventive Principle:
Principle #24Intermediary (Mediator)

2Ease of operation

If a single-layer hydrophilic coating is used, then lubricious performance is achieved, but adhesion to hydrophobic substrates is insufficient

Engineering Contradiction:
Improvelubricious performanceVSAvoidadhesion strength
Core Design Contradiction:
Ease of operationVSStrength

Solution Approach 1:

The coating system is segmented into functional layers: a base layer with hydrophobic polymer and adhesion promoter for substrate bonding, and a top layer with hydrophilic polymer for lubrication. This resolves the contradiction by separating adhesion and lubrication functions into different layers.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The coating uses composite material structure combining hydrophobic polymer (for adhesion to hydrophobic substrates) and hydrophilic polymer (for lubricious performance). This composite approach allows simultaneous achievement of strong adhesion and excellent lubrication.

Inventive Principle:
Principle #40Composite materials

3Ease of operation

If hydrophilic polymer coating is applied to hydrophobic substrates without proper adhesion promotion, then lubricious performance is improved, but particulate release increases

Engineering Contradiction:
Improvelubricious performanceVSAvoidparticulate release
Core Design Contradiction:
Ease of operationVSObject-generated harmful factors

Solution Approach 1:

The coating is segmented into a stable base layer that anchors to the substrate and a lubricious top layer that minimizes friction. This segmentation prevents the top layer from detaching and forming particulates, as the base layer provides strong anchoring.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The base layer with adhesion promoter is applied first to establish strong substrate bonding before applying the hydrophilic top layer. This preliminary action ensures the coating system is firmly anchored, preventing particulate release during device insertion and removal.

Inventive Principle:
Principle #10Preliminary action

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 coating achieves robust adhesion to a wide range of substrates, significantly reduces friction force, and minimizes particulate release, ensuring stability and safety during medical device insertion and removal.

Implementation Method 1

a polymeric adhesion promoter which is a block copolymer comprising hydrophobic and hydrophilic polymer blocks and/or a hydrophilic polymer comprising hydrophilic functional groups, where from 10% to 100% of the hydrophilic functional groups are capped with a hydrophobic functional group

Methodology Applied
Scientific EffectAdhesion: Adhesive

Implementation Method 2

a first crosslinked polymeric matrix formed by a first monomeric or polymeric crosslinking agent

Methodology Applied
Scientific EffectCrosslinking: Chemical Bonding

Implementation Method 3

a top lubricious layer formed by curing a hydrophilic curable polymer with a crosslinking agent

Methodology Applied
Scientific EffectCuring: Photopolymerisation

Implementation Method 4

Lubricious coatings are designed to provide medical devices with a slippery surface, which enhances the comfort of a subject during insertion, placement and/or removal of the medical device

Methodology Applied
Scientific EffectLubrication: Lubrication

Data Source

PatentEP3302595B1Coating compositions comprising adhesion promoting base layer
Publication Date: 2022.10.26 JMEDTECH XIAMEN COATING TECH CO LTD
  • EP3302595B1 patent drawingFigure 1(a)~2
  • EP3302595B1 patent drawingFigure 3~4
  • EP3302595B1 patent drawingFigure 5

AI summary

Described herein are coatings and formulations thereof for coating a substrate for use in producing a lubricious coating on a substrate surface that is to be inserted into the body lumen of a subject. Said coatings all contain an adhesion promoting coating formulation for applying to a substrate material that is formed from a polymeric adhesion promoter, a monomeric or polymeric crosslinking agent and a photoinitiator, where the polymeric adhesion promoter is a block copolymer comprising hydrophobic and hydrophilic polymer blocks and/or a hydrophilic polymer comprising hydrophilic functional groups, where from 10% to 100% of the hydrophilic functional groups are capped with a hydrophobic functional group and the formulations thereof further contain a solvent to enable the coating to be applied to a substrate surface.