Polyurethane Stent Bonding via SiO2 Adhesion Layers

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Solution Overview

Problem

The durable bonding of polyurethane polymers to stent frames, especially under cyclic mechanical stresses and for biomedical implants like heart valves, is challenging due to embedding issues that affect the implant's compatibility and delivery.

Innovation Solution

A multi-layered adhesion method involving the deposition of an SiO2 layer, followed by hydroxysilane and urethane (meth)acrylate compounds, and finally a polyurethane (meth)acrylate compound, to form a strong bond between the polyurethane polymer and the substrate, ensuring the polymer can withstand dynamic and cyclical loads.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a spray coating process is used to form the prosthetic heart valve by coating the frame and leaflet form together, then the manufacturing process is simplified, but the frame structure becomes embedded in the polymer base which increases the foreign material surface area and complicates catheter delivery

Engineering Contradiction:
Improvemanufacturing process simplicityVSAvoidcatheter delivery ease
Core Design Contradiction:
Ease of manufactureVSEase of operation

Solution Approach 1:

The invention divides the coating process into separate stages: first coating the frame structure, then separately forming and attaching the leaflet form. This segmentation prevents the frame from being embedded in the polymer base while still achieving complete coverage, thereby maintaining ease of manufacture without compromising delivery capability.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The frame is pre-coated with polymer material before the leaflet form is attached. This preliminary action ensures that the frame surface is prepared for subsequent leaflet attachment while maintaining frame visibility and accessibility, avoiding embedding issues that would complicate catheter delivery.

Inventive Principle:
Principle #10Preliminary action

2Strength

If the frame is embedded in the polymer base to increase coverage, then the structural integrity is improved, but the actual frame is not discernible which increases foreign material surface area and affects body acceptance

Engineering Contradiction:
Improvestructural integrityVSAvoidforeign material surface area
Core Design Contradiction:
StrengthVSObject-affected harmful factors

Solution Approach 1:

The invention applies polymer coating selectively: the frame structure receives a initial coating layer that maintains its discernibility, while the leaflet form receives the primary polymer coverage. This local differentiation ensures structural integrity through adequate coating while minimizing unnecessary foreign material surface area exposure.

Inventive Principle:
Principle #3Local quality

3Reliability

If more polymer base material is present to ensure complete coverage, then the bonding durability is improved, but the implant becomes more difficult to compress for catheter delivery

Engineering Contradiction:
Improvebonding durabilityVSAvoidcompression ease for delivery
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The invention applies polymer coating in controlled amounts: sufficient to ensure complete coverage and durable bonding between frame and leaflet form, but not excessive to the point of impeding compression. The separate formation and attachment process allows precise control of polymer quantity, achieving reliability without compromising deliverability.

Inventive Principle:
Principle #16Partial or excessive 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

This method achieves a robust and durable bond that enhances the mechanical performance of biomedical implants, improving their compatibility and ease of delivery, with the polyurethane polymer layer effectively adhering to the substrate without embedding the frame, thus maintaining structural integrity under cyclic loads.

Implementation Method 1

depositing an SiO2 layer onto the substrate

Methodology Applied
Scientific EffectPhysical Vapour Deposition: Physical Vapour Deposition

Implementation Method 2

subjecting to conditions suitable to at least partially effect a condensation reaction between Si-OH groups of the SiO2 layer and the hydroxysilane compound

Methodology Applied
Scientific EffectCondensation reaction: Condensation

Implementation Method 3

subjecting to conditions suitable to at least partially effect a reaction between the carbon-carbon double bonds present in the first adhesive layer and the urethane (meth)acrylate compound

Methodology Applied
Scientific EffectPolymerization reaction: Photopolymerisation

Implementation Method 4

subjecting to conditions suitable to at least partially effect a reaction between the (meth)acrylate groups and/or carbon radicals present in the second adhesive layer and the polyurethane (meth)acrylate compound

Methodology Applied
Scientific EffectFree radical polymerization: Photopolymerisation

Data Source

PatentEP3307339B1Method for bonding a polyurethane polymer to a substrate, in particular for the manufacturing of stents
Publication Date: 2020.12.16 RWTH AACHEN UNIV
  • EP3307339B1 patent drawingFigure 1a~1c
  • EP3307339B1 patent drawingFigure 1d~1e
  • EP3307339B1 patent drawingFigure 2~3

AI summary

The present invention relates to a method for bonding a polyurethane polymer to a substrate using a multi-layered adhesion approach. Steps of the method include A) selecting a polyurethane polymer to be bonded to the substrate (100); B) depositing an SiO2 layer (200) onto the substrate (100); C) contacting the SiO2 layer (200) with a hydroxysilane compound, thereby forming a first adhesive layer (300) bonded to the SiO2 layer (200); D) contacting the first adhesive layer (300) with a urethane (meth)acrylate compound, thereby forming a second adhesive layer (400) bonded to the first adhesive layer (300); E) contacting the second adhesive layer (400) with a polyurethane (meth)acrylate compound, thereby forming a third adhesive layer (500) bonded to the second adhesive layer (400); F) contacting the third adhesive layer (500) with the polyurethane polymer selected in step A); G) solidifying the polyurethane polymer of step F). The invention further relates to an article obtainable by the method according to the invention, in particular a biomedical implant such as a heart valve stent.