Elastomeric Slit Coating for Sterilization Resistance

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Solution Overview

Problem

Medical devices with radiation-crosslinkable materials, such as silicone elastomers, often experience undesirable slit closure during gamma sterilization, leading to opacity and material property changes, while liquid additives lack sufficient wettability and steadfastness to prevent this issue effectively.

Innovation Solution

A medical device with an elastically deformable functional part featuring a composition of biocompatible oil and thickener applied to the slit wall faces, which prevents slit closure and maintains transparency, even under radiation sterilization, by using a combination of biocompatible oils like silicone oil and thickeners like polytetrafluoroethylene (PTFE) or silica.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If gamma irradiation sterilization is applied to medical devices with radiation-crosslinkable materials, then sterilization is achieved, but the materials undergo crosslinking reactions causing slit closure and loss of transparency

Engineering Contradiction:

Improvesterilization effectivenessVSAvoidslit openness

Core Design Contradiction:

ReliabilityVSShape

Solution Approach 1:

A liquid separating agent is introduced as an intermediary substance between the slit walls. This agent prevents direct contact and adhesion of the elastomer surfaces during sterilization, thereby preventing crosslinking-induced slit closure while allowing the sterilization process to proceed effectively

Inventive Principle:

Principle #24Intermediary (Mediator)

Solution Approach 2:

The physical and chemical parameters of the separating agent are specifically optimized to withstand gamma irradiation conditions. The agent's composition, viscosity, and chemical stability are adjusted to maintain its separating function throughout the sterilization process without degrading or losing effectiveness

Inventive Principle:

Principle #35Parameter changes

2Shape

If liquid separating agents are used to prevent slit closure, then slit openness is maintained, but the agents lack sufficient wettability and steadfastness under elevated temperatures

Engineering Contradiction:

Improveslit opennessVSAvoidseparating agent performance

Core Design Contradiction:

ShapeVSReliability

Solution Approach 1:

The chemical composition and physical parameters of the separating agent are specifically optimized for thermal stability and wettability. The agent's viscosity, surface tension, and chemical resistance are adjusted to maintain effective separation under elevated temperatures during sterilization and ageing processes

Inventive Principle:

Principle #35Parameter changes

Solution Approach 2:

The separating agent is formulated as a composite liquid composition with specific chemical components that provide both wettability and thermal steadfastness. This composite formulation ensures the agent maintains its separating function under various thermal and chemical conditions throughout the device's lifecycle

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 solution effectively prevents slit closure during radiation sterilization, maintains transparency, and enhances the material's ageing resistance, allowing for sterilization with high radiation doses without adverse effects on the device's functionality or appearance.

Implementation Method 1

liquid additives are also used as separating agents

Methodology Applied

Scientific EffectSeparation effect:

Implementation Method 2

the manner in which the slit arrangement widens upon the elastic deformation of the elastically deformable functional part or the slit arrangement opens upon the elastic deformation of the elastically deformable functional part is such that said slit arrangement allows a flow of a fluid

Methodology Applied

Scientific EffectWetting: Wetting

Implementation Method 3

If the medical devices comprise a radiation-crosslinkable material, such as silicone elastomers, these materials will react with crosslinking reactions when exposed to high-energy radiation

Methodology Applied

Scientific EffectRadiation crosslinking: Photopolymerisation

Implementation Method 4

the slit arrangement widens, opens or opens out upon elastic deformation of the elastically deformable functional part

Methodology Applied

Scientific EffectElastic deformation: Elasticity

Data Source

PatentUS20240034952A1Medical device, functional part for a medical device and method for sterilizing and/or producing sterilization resistance of a medical device or functional part

Publication Date: 2024.02.01 B BRAUN MELSUNGEN AG

AI summary

A medical device, an elastically deformable functional part for a medical device, and a method for sterilizing and/or for establishing sterilization resistance of a medical device or an elastically deformable functional part. The elastically deformable functional part has an openable slit arrangement that widens or opens upon elastic deformation of the elastically deformable functional part and recloses upon cessation of the elastic deformation. The slit wall faces of the slit arrangement are coated with a composition that includes a silicone oil and a thickener.