Radiation-Activated Hydration Gel for Catheter Sterilization

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Solution Overview

Problem

Hydrophilic medical devices, such as urinary catheters, face degradation and increased coefficient of friction when sterilized in a hydrated state due to radiation exposure, leading to instability and potential detachment issues.

Innovation Solution

Radiation-activated hydration gels are used to retain fluid until exposure to sterilizing radiation, which then degrades to release fluid, hydrating the hydrophilic coating and maintaining lubricity while preventing fluid contact during sterilization, thereby ensuring a sterilized and ready-to-use medical device.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If hydrophilic medical devices are sterilized in a hydrated state using radiation, then sterilization is achieved, but the coating degrades and coefficient of friction increases

Engineering Contradiction:
Improvesterilization effectivenessVSAvoidcoating integrity and lubricity
Core Design Contradiction:
ReliabilityVSStrength

Solution Approach 1:

The system separates the sterilization process from the hydration process. The medical device is sterilized in a dry state, then later hydrated through controlled fluid release from the gel, avoiding radiation exposure of the hydrated coating

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The device is sterilized in advance in a dry state before hydration occurs. The hydrophilic coating is sterilized while dry, then hydrated later through controlled fluid release from the radiation-sensitive gel, ensuring sterilization completes before hydration begins

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If hydrophilic coating is wetted with wetting fluid to improve lubricity, then ease of insertion is improved, but radiation sterilization damages the coating

Engineering Contradiction:
Improveease of insertionVSAvoidcoating stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The device is sterilized in advance in a dry state before hydration occurs. The hydrophilic coating is sterilized while dry, then hydrated later through controlled fluid release from the radiation-sensitive gel, ensuring sterilization completes before hydration begins

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

A radiation-sensitive gel acts as an intermediary fluid release mechanism. The gel contains fluid that is released only after sterilization, mediating between the sterilization process and the hydration need, preventing direct contact between radiation and hydrated coating

Inventive Principle:
Principle #24Intermediary (Mediator)

3Ease of operation

If medical device is stored in contact with water to be ready-to-use, then ease of operation is improved, but sterilization must be performed in hydrated state causing coating degradation

Engineering Contradiction:
Improveready-to-use conditionVSAvoidradiation damage to coating
Core Design Contradiction:
Ease of operationVSObject-affected harmful factors

Solution Approach 1:

The device is sterilized in advance in a dry state before hydration occurs. The hydrophilic coating is sterilized while dry, then hydrated later through controlled fluid release from the radiation-sensitive gel, ensuring sterilization completes before hydration begins

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

The system changes the physical state parameters of the fluid - storing it in a gel phase that releases liquid only after sterilization. This parameter change allows the device to remain dry during sterilization then become hydrated for use

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

The solution effectively sterilizes hydrophilic medical devices without degrading the coating, maintaining lubricity and adhesion, and reducing staining risks, resulting in a ready-to-use product with improved performance and reduced user inconvenience.

Implementation Method 1

a gel that retains a fluid

Methodology Applied
Scientific EffectGel: Gel

Implementation Method 2

when the gel is exposed to radiation, such as sterilizing E-beam or gamma radiation, the gel degrades or breaks down, thereby releasing fluid

Methodology Applied
Scientific EffectRadiation: Radiation

Implementation Method 3

the released fluid hydrates the hydrophilic coating on the medical device

Methodology Applied
Scientific EffectHydration: Hydrophile

Data Source

PatentEP3721910B1Radiation activated gels that release fluids and assemblies containing the same
Publication Date: 2023.11.01 HOLLISTER INCORPORAED
  • EP3721910B1 patent drawingFigure 1~2d

AI summary

Gels that release fluid and assemblies containing the same.