Elastomeric Slit Coating for Radiation Sterilization Stability
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Solution Overview
Problem
Medical devices with radiation-crosslinkable materials, such as silicone elastomers, often experience slit closure during gamma irradiation, leading to transparency loss and material property changes when additives are used to prevent this, and liquid separating agents fail to maintain effectiveness under elevated temperatures and radiation.
Innovation Solution
A medical device with an elastically deformable functional part featuring slit wall faces coated with a biocompatible solid separating agent, which prevents slit closure and maintains transparency during radiation sterilization, using a solid agent that is free of liquids and applied only to the slit wall faces to avoid material property changes.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If additives are added to prevent slit closure during gamma irradiation, then slit closure is prevented, but transparency is lost and material properties change fundamentally
Solution Approach 1:
A liquid separating agent is introduced as an intermediary substance between the slit walls to prevent adhesion and closure during gamma irradiation. This mediator layer prevents direct contact between opposing slit surfaces, maintaining slit patency without requiring solid additives that would compromise transparency or fundamental material properties.
Solution Approach 2:
The invention changes the physical state of the separating agent from solid to liquid, and specifically selects a separating agent with low polar surface energy that remains stable under gamma irradiation conditions. This parameter change enables the agent to maintain its separating function during sterilization while preserving the transparency and fundamental properties of the elastomeric material.
2Reliability
If liquid separating agents are used to prevent slit closure, then slit opening is maintained, but the separating effect diminishes under elevated temperatures and radiation
Solution Approach 1:
The invention selects a liquid separating agent with specific physical-chemical parameters, particularly low polar surface energy, that remains stable under gamma irradiation and elevated temperatures. This parameter selection ensures the separating agent maintains its liquid state and separating function throughout sterilization and storage, preventing both slit closure and material degradation.
Solution Approach 2:
The separating agent is designed to be a simple liquid coating that can be applied in thin layers and provides sufficient protection for the intended sterilization and storage period. The agent is selected to be cost-effective and sufficiently durable for the application lifecycle without requiring complex formulations.
3Reliability
If solid additives are used to prevent slit closure, then radiation-induced healing is prevented, but material properties change fundamentally
Solution Approach 1:
Instead of incorporating solid additives into the bulk elastomeric material, the invention applies a liquid separating agent as a surface coating on the slit walls. This intermediary layer prevents radiation-induced adhesion without altering the fundamental composition or properties of the elastomeric material itself, maintaining material stability while providing radiation resistance.
Solution Approach 2:
The separating agent is applied locally to the slit wall surfaces rather than being distributed throughout the entire material volume. This localized application prevents slit closure at the critical interface region while leaving the bulk material properties unchanged, preserving the fundamental characteristics of the elastomeric material.
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 gamma radiation sterilization and enhances ageing resistance while maintaining transparency, allowing for radiation sterilization with high doses without slit closure and preserving material properties.
Implementation Method 1
Gamma irradiation is a common sterilization method for medical devices. 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.
Implementation Method 2
these materials will react with crosslinking reactions when exposed to high-energy radiation
Data Source
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. The slit arrangement widens or opens upon elastic deformation of the elastically deformable functional part and recloses upon cessation of the elastic deformation. The slit arrangement has slit wall faces with a separating agent. The separating agent can be a solid.