Hydrophilic Coating Sterilization with Polyol Mediator
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Solution Overview
Problem
Sterilization of hydrophilically coated medical devices, such as urinary catheters, using radiation can lead to degradation or excessive crosslinking of the coating, resulting in increased friction and potential detachment from the device, especially when in a hydrated state.
Innovation Solution
Contacting the hydrophilic coating with a wetting fluid containing non-polymeric polyols and exposing it to radiation, such as gamma or E-Beam radiation, to maintain coating stability and adhesion during sterilization.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the hydrophilic coating is sterilized using radiation while in a hydrated state, then sterilization is achieved, but the coating degrades or undergoes excessive crosslinking leading to increased friction and potential detachment
Solution Approach 1:
The patent introduces a polyol additive as an intermediary substance during radiation sterilization. The polyol acts as a mediator that protects the hydrophilic coating from radiation-induced degradation and excessive crosslinking, thereby maintaining coating stability while achieving effective sterilization.
Solution Approach 2:
The patent modifies the chemical composition parameters of the wetting fluid by adding polyol additives. This parameter change transforms the wetting fluid from a simple protective medium into an active protective composition that chemically interferes with radiation-induced coating degradation processes.
2Reliability
If the hydrophilic coating is sterilized using radiation while in a hydrated state, then sterilization is achieved, but the coefficient of friction increases and lubricity decreases
Solution Approach 1:
The polyol additive serves as an intermediary that protects the hydrophilic coating's lubricous properties during radiation sterilization. By intervening in the radiation-coating interaction, the polyol prevents friction-increasing side reactions while allowing sterilization to proceed.
Solution Approach 2:
The patent converts the potentially harmful effect of radiation on coating lubricity into a beneficial outcome. By using polyol additives, the radiation process is transformed from a harmful degradation mechanism into a controlled sterilization process that preserves or even enhances coating performance.
3Reliability
If the hydrophilic coating is sterilized using radiation while in a hydrated state, then sterilization is achieved, but the coating may detach from the medical device
Solution Approach 1:
The polyol additive acts as a protective intermediary between the radiation field and the hydrophilic coating adhesion interface. It prevents radiation-induced bond breaking and crosslinking that would otherwise compromise coating attachment to the medical device.
Solution Approach 2:
The polyol additive provides beforehand cushioning protection against radiation-induced coating detachment. By being present before radiation exposure, it pre-establishes a protective chemical environment that buffers against adhesion failure during sterilization.
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 keeps the coefficient of friction low and maintains the stability and attachment of the hydrophilic coating, ensuring the coating remains lubricious and securely attached to the substrate even after sterilization, allowing for a ready-to-use medical device in a sealed package.
Implementation Method 1
contacting the hydrophilic coating of a medical device with an aqueous solution containing one or more non-polymeric polyols
Implementation Method 2
exposing the medical device to radiation
Data Source
AI summary
Methods for sterilizing a substrate with radiation and radiation sterilized substrates.