Acid Functionalized Medical Device Coating via Plasma Treatment

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Solution Overview

Problem

Existing medical devices coated with bioactive materials face challenges in achieving consistent and reliable coatings, leading to variable bioactive results due to inadequate adhesion and release characteristics, which fail to meet regulatory requirements and can cause foreign body reactions.

Innovation Solution

The method involves surface functionalization using low-power plasma treatment with acids or bases, such as acrylic acid, to increase surface energy and adhesion, allowing for a uniform and repeatable bioactive layer without the need for containment mechanisms like polymers or matrices, ensuring strong covalent bonding of bioactive agents directly to the device surface.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of manufacture

If a bioactive coating is applied to an untreated medical device surface, then the coating process is simple, but the coating uniformity and adhesion are poor

Engineering Contradiction:
Improvecoating process simplicityVSAvoidcoating uniformity
Core Design Contradiction:
Ease of manufactureVSManufacturing precision

Solution Approach 1:

The medical device surface is subjected to plasma treatment before coating application to enhance surface energy and create optimal conditions for coating adhesion. This preliminary surface modification ensures uniform and reliable coating formation without complicating the overall manufacturing process.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The surface energy and chemical composition of the medical device are modified through plasma treatment, changing the surface parameters to be more receptive to bioactive material coating. This parameter change enables consistent coating uniformity and strong adhesion.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If containment mechanisms like polymer matrices are used to hold bioactive material, then the bioactive material adhesion is improved, but the device complexity increases and additional containment substances are required

Engineering Contradiction:
Improvebioactive material adhesionVSAvoidcoating structure complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The invention extracts and eliminates the need for containment mechanisms such as polymer matrices or carriers. By using plasma-treated surfaces with enhanced surface energy, the bioactive material adheres directly to the medical device without requiring additional containment substances, thereby reducing device complexity.

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The plasma-treated surface itself provides the adhesion function that would otherwise require separate containment mechanisms. The modified surface acts as its own binding medium, eliminating the need for additional polymer matrices or carriers while maintaining reliable bioactive material adhesion.

Inventive Principle:
Principle #25Self-service

3Duration of action of moving object

If containment devices are used to control bioactive material release, then the release rate can be controlled, but the amount of bioactive material that can be carried is reduced

Engineering Contradiction:
Improverelease rate controlVSAvoidbioactive material loading capacity
Core Design Contradiction:
Duration of action of moving objectVSQuantity of substance

Solution Approach 1:

The invention removes containment devices that limit bioactive material loading capacity. The plasma-treated surface enables direct adhesion of bioactive material without containment barriers, maximizing the amount of material that can be carried while maintaining controlled release through surface-specific interactions.

Inventive Principle:
Principle #2Taking out (Extraction)

4Object-affected harmful factors

If conventional surface treatments are used to improve biocompatibility, then the surface properties are modified, but consistent and reliable coating adhesion is not achieved

Engineering Contradiction:
ImprovebiocompatibilityVSAvoidcoating adhesion consistency
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The invention uses plasma treatment to fundamentally change the surface parameters of the medical device, creating a surface with enhanced surface energy and chemical groups that reliably bind bioactive materials. This parameter modification achieves both improved biocompatibility and consistent, reliable coating adhesion.

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

This approach significantly enhances the adhesion and uniformity of bioactive coatings, increasing the amount of bioactive material retained on the device and ensuring consistent drug release, meeting regulatory standards without the use of additional containment substances.

Implementation Method 1

The at least one surface of the structure is functionalised by subjecting the at least one surface to acidification or basification

Methodology Applied
Scientific EffectPlasma: Plasma

Implementation Method 2

ensuring strong covalent bonding of bioactive agents directly to the device surface

Methodology Applied
Scientific EffectCovalent bonding: Chemical Bonding

Data Source

PatentEP3797802B1Acid functionalised coated medical device and method of coating such a device
Publication Date: 2023.05.10 COOK MEDICAL TECHNOLOGIES LLC
  • EP3797802B1 patent drawingFigure 1~3
  • EP3797802B1 patent drawingFigure 4
  • EP3797802B1 patent drawingFigure 5~6

AI summary

A medical device such as a stent (10) or medical balloon (40) is functionalised prior to coating with a bioactive material (54), specifically by acidification or basification the contact surface or surfaces (50) of the medical device. Functionalisation with subsequent coating of bioactive agent directly onto the functionalised surface provides a significantly more consistent and reliable coating of bioactive agent on a medical device without requiring containment or time release devices.