Wetting Agent Composition for Sterilization-Stable Medical Coatings

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Solution Overview

Problem

Existing medical device coatings are prone to degradation from reactive species formed during sterilization processes, particularly irradiation, and lose lubricious properties over time, limiting their effectiveness and applicability to specific types of coatings.

Innovation Solution

A liquid composition comprising gallic acid or its derivatives, ethylene glycol, diethylene glycol, propylene glycol, or glycerol, and an aqueous base solution, which acts as an antioxidant to prevent or retard coating degradation from irradiation and hydrolysis, maintaining lubricious properties and stability across various coating types.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If hydrophilic coatings are sterilized by irradiation or autoclaving, then sterilization is achieved, but the coatings lose water retention and lubricious properties

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidwater retention and lubricious properties
Core Design Contradiction:
ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent introduces a wetting liquid as an intermediary substance that mediates between the sterilization process and the hydrophilic coating. This liquid composition, containing antioxidants and hydrophilic polymers, protects the coating from direct damage by reactive species generated during irradiation or autoclaving, while maintaining the coating's water retention and lubricious properties throughout the sterilization process and storage period.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The patent applies preliminary action by pre-contacting the hydrophilic coating with a specially formulated wetting liquid before sterilization. This liquid composition is designed to remain stable under sterilization conditions and continue to protect the coating after sterilization, preventing degradation and maintaining lubricious properties without requiring post-sterilization treatment.

Inventive Principle:
Principle #10Preliminary action

2Stability of the object's composition

If hydrophilic polymers are added to the wetting liquid, then water retention and lubricious properties are maintained, but the composition becomes more complex and costly

Engineering Contradiction:
Improvewater retention and low frictionVSAvoidcomposition complexity
Core Design Contradiction:
Stability of the object's compositionVSDevice complexity

Solution Approach 1:

The patent applies parameter changes by carefully selecting and optimizing the molecular weight, concentration, and chemical structure of hydrophilic polymers in the wetting liquid. By adjusting these parameters, the formulation achieves effective water retention and lubricious properties while minimizing complexity. The patent specifies particular polymer types and concentration ranges to balance performance with formulation simplicity.

Inventive Principle:
Principle #35Parameter changes

3Ease of operation

If a ready-to-use medical device is stored in wetting liquid, then the coating remains lubricious, but sterilization may degrade the coating

Engineering Contradiction:
Improveready-to-use lubricious propertyVSAvoidcoating stability after sterilization
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent treats the wetting liquid as a disposable protective medium that is consumed during sterilization. The formulation is designed to sacrificially protect the expensive hydrophilic coating by absorbing the damage from sterilization processes. After sterilization, the liquid may be replaced or the device is used immediately, ensuring the coating remains intact and functional.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

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 composition effectively protects a wide range of functional coatings from degradation, ensuring lubricious properties and stability under irradiation and hydrolytic conditions, allowing for easy preparation and cost-effective, non-toxic use in ready-to-use medical devices.

Implementation Method 1

comprising an antioxidant selected from gallic acid or a derivative thereof... which acts as an antioxidant to prevent or retard coating degradation from irradiation

Methodology Applied
Scientific EffectAntioxidant: Oxidation

Implementation Method 2

preventing or retarding degradation of a functional coating on a medical device... from hydrolysis

Methodology Applied
Scientific EffectHydrolysis resistance: Hydrolysis

Data Source

PatentEP3496773B1Wetting agent formulation
Publication Date: 2025.12.17 TELEFLEX LIFE SCIENCES LLC
  • EP3496773B1 patent drawing
  • EP3496773B1 patent drawing
  • EP3496773B1 patent drawing

AI summary

The present invention relates in a first alternative to a composition for preventing or retarding degradation of a functional coating on a medical device comprising an antioxidant selected from gallic acid or a derivative thereof. The present invention relates in a second alternative to a composition for preventing or retarding degradation of a functional coating on a medical device comprising carboxymethyl cellulose or a derivative or salt thereof. The present invention also relates to the use of the compositions for preventing or retarding degradation of a functional coating on a medical device from reactive species generated during exposure of radiation, and a wetting agent comprising the compositions. Furthermore, the wetting agent prevents or retards the hydrolytic degradation of the coating during the intended shelf- life of the wetted coated product.