Ready-to-use urinary catheter with dry-state sterilization

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Solution Overview

Problem

Urinary catheters with hydrophilic coatings face challenges in sterilization, particularly with wet sterilization methods that can damage the coating, and existing solutions for ready-to-use catheters are complex, expensive, or difficult for users with limited dexterity to activate, leading to inadequate wetting and increased infection risks.

Innovation Solution

A method involving a catheter assembly with a first compartment containing the catheter and a second compartment for the liquid swelling medium, where the catheter is sterilized in a dry state, and the swelling medium is added after sterilization to activate the coating, ensuring consistent friction reduction and extended shelf life without compromising the coating's water retention.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If wet sterilization is performed on catheters with hydrophilic coatings, then sterilization can be achieved, but the coating loses water retention ability and friction increases

Engineering Contradiction:
ImprovesterilizationVSAvoidcoating water retention
Core Design Contradiction:
ReliabilityVSManufacturing precision

Solution Approach 1:

The patent divides the catheter system into two separate compartments: a first compartment for the catheter with hydrophilic coating and a second compartment for the wetting fluid. This segmentation prevents contact between the coating and wetting fluid during storage and sterilization, allowing independent optimization of each component while maintaining overall functionality.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter is sterilized in a dry state before use, and the wetting fluid is applied only after sterilization is complete. This preliminary action sequence ensures that the hydrophilic coating is not exposed to wetting fluid during the sterilization process, preventing loss of water retention ability while still achieving complete sterilization.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If hydrophilic coating is maintained constantly wetted, then immediate use is ready, but sterilization becomes cumbersome and impossible with conventional techniques

Engineering Contradiction:
Improveready-to-useVSAvoidsterilization process
Core Design Contradiction:
Ease of operationVSEase of manufacture

Solution Approach 1:

By separating the catheter and wetting fluid into different compartments, the system allows the catheter to be sterilized in a dry state using conventional techniques, while the wetting fluid remains separate and sterile. This segmentation makes both sterilization and ready-to-use functionality achievable without contradiction.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The catheter is prepared and sterilized in advance in a dry state, then the wetting fluid is applied just before use. This preliminary preparation allows conventional sterilization techniques to be used while still achieving immediate readiness for use after the simple act of applying the wetting fluid.

Inventive Principle:
Principle #10Preliminary action

3Ease of manufacture

If wetting fluid is kept separate from hydrophilic surface, then sterilization is simplified, but activation process becomes complicated and tedious for users

Engineering Contradiction:
ImprovesterilizationVSAvoidactivation process
Core Design Contradiction:
Ease of manufactureVSEase of operation

Solution Approach 1:

The catheter and wetting fluid are combined into a single integrated assembly with a shared compartment system. This merging allows the benefits of separate sterilization while simplifying the activation process, as the wetting fluid is already positioned and ready to be applied to the catheter surface through a simple user action.

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The wetting fluid is pre-positioned in the second compartment during manufacturing, so that when the user activates the catheter, they simply need to transfer the fluid from the second compartment to the first compartment. This preliminary positioning eliminates the need for complex activation procedures while maintaining sterilization simplicity.

Inventive Principle:
Principle #10Preliminary action

4Reliability

If large volumes of wetting fluid are used, then adequate wetting is ensured, but product weight increases and logistics become complicated

Engineering Contradiction:
Improvewetting adequacyVSAvoidproduct weight
Core Design Contradiction:
ReliabilityVSWeight of moving object

Solution Approach 1:

Instead of using large volumes of wetting fluid throughout the entire catheter assembly, the system applies wetting fluid locally only where needed on the hydrophilic coating surface. The first compartment is designed to contain minimal necessary fluid, reducing weight while ensuring adequate wetting of the coating surface for proper functionality.

Inventive Principle:
Principle #3Local quality

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 method provides a ready-to-use catheter that is safe, easy to use, and maintains low friction and water retention, reducing infection risks and manufacturing costs, while allowing for extended shelf life and simplified logistics.

Implementation Method 1

a first compartment comprising a catheter, said catheter comprises on at least a part of its surface an exterior coating arranged to reduce the coefficient of friction after treatment with a liquid swelling medium

Methodology Applied
Scientific EffectSwelling:

Implementation Method 2

the catheter assembly is wrapped or placed in a gas-impermeable package sterilising the catheter assembly

Methodology Applied
Scientific EffectPhysical containment: Physical Containment

Data Source

PatentEP3257546B1Method of preparing a ready-to-use urinary catheter
Publication Date: 2022.10.05 TELEFLEX LIFE SCI PTE LTD
  • EP3257546B1 patent drawingFigure 1~2
  • EP3257546B1 patent drawingFigure 3~4
  • EP3257546B1 patent drawingFigure 5~6

AI summary

A method of preparing a ready-to-use catheter, said method comprising: providing a catheter assembly (1, 1', 1", 1"'), comprising: a first compartment (2) comprising a catheter (3), said catheter (3) comprises on at least a part of its surface (6) an exterior coating (7) designed to reduce the coefficient of friction after treatment with a liquid swelling medium (5), and a second compartment (4) comprising the liquid swelling medium (5), said method further comprises sterilising the catheter assembly (1, 1', 1", 1"'), adding the liquid swelling medium (5) to the first compartment (2) for wetting/activating the catheters exterior coating (7), and storing the ready-to-use catheter. By using the method according to the invention, the sterilisation of the catheter is effectuated in a dry-state, ensuring that the known problems with wet-sterilisation are completely eliminated and the need for preparing complicated and expensive liquid swelling mediums are no longer a requirement.