Catheter Wetting Fluid with High Osmolality

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Solution Overview

Problem

Hydrophilic catheters face issues with water loss and drying out when inserted into the urethra due to osmotic potential differences with mucous membranes, leading to reduced friction and potential patient discomfort, and existing methods for incorporating osmolality-increasing compounds are cumbersome and costly with unpredictable results.

Innovation Solution

A catheter assembly with a wetting fluid containing osmolality-increasing compounds at a concentration exceeding 600 mOsm/dm3, which is used to maintain the hydrophilic surface in a stable, low-friction state, either integrated with the catheter or applied separately, ensuring stability and reduced crystalline growth.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If a hydrophilic coating is applied to the catheter surface, then low-friction properties are achieved, but the coating loses water and dries out when inserted into the urethra due to osmotic potential difference

Engineering Contradiction:
Improvelow-friction propertiesVSAvoidwater retention stability
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The patent changes the osmotic parameter of the hydrophilic coating by incorporating osmolality-increasing compounds (such as salts, sugars, or amino acids) into the coating formulation. This increases the osmotic potential of the coating to match or exceed that of the mucous membrane, preventing water loss and maintaining the coating's hydrophilic properties during insertion and use.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If osmolality-increasing compounds are incorporated into the hydrophilic coating, then water retention and stability are improved, but the production process becomes more complex and costly

Engineering Contradiction:
Improvecoating stabilityVSAvoidproduction process complexity
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The patent combines the osmolality-increasing compounds with the hydrophilic polymer materials during the coating formation process itself, rather than applying them as separate subsequent steps. This integration allows both functions (hydrophilicity and osmotic balance) to be achieved in a single coating application, simplifying the overall production process while maintaining coating stability.

Inventive Principle:
Principle #5Merging (Combining)

3Ease of operation

If conventional wetting fluids are used, then the catheter can be inserted, but the properties of the activated coating become unpredictable due to variations in wetting parameters

Engineering Contradiction:
Improvecatheter insertionVSAvoidcoating activation consistency
Core Design Contradiction:
Ease of operationVSManufacturing precision

Solution Approach 1:

The patent specifies precise parameters for the wetting fluid, including osmolality (matching or exceeding that of the coating), pH range, and temperature. By controlling these parameters, the patent ensures predictable and consistent activation of the coating properties, eliminating variability in catheter performance regardless of wetting conditions.

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 high concentration of osmolality-increasing compounds in the wetting fluid significantly improves the stability and water retention of the hydrophilic surface, reducing friction and sensitivity to moisture, resulting in a more reliable and cost-effective production process with predictable properties.

Implementation Method 1

the hydrophilic polymer surface may lose water and dry out when it comes in contact with e.g. a mucous membrane... because of a difference between the osmotic potential of the hydrophilic surface and the osmotic potential of the mucous membrane

Methodology Applied
Scientific EffectOsmosis: Osmosis

Data Source

PatentUS8267919B2Catheter assembly with osmolality-increasing fluid
Publication Date: 2012.09.18 ASTRA TECH AB
  • US8267919B2 patent drawing
  • US8267919B2 patent drawing
  • US8267919B2 patent drawing

AI summary

A catheter assembly is disclosed comprising: a hydrophilic catheter; a wetting fluid for wetting of the catheter; and a receptacle enclosing at least the insertable part of the catheter and the wetting fluid. Further, the wetting fluid is a solution incorporating at least one osmolality-increasing compound, and the total concentration of the osmolality-increasing compound(s) is very high, preferably exceeding 600 mOsm/dm3. The wetting fluid could either be arranged in contact with the hydrophilic surface layer of the catheter in the receptacle, for preservation of the hydrophilic surface layer in a wetted state during accommodation in said receptacle and provision of a ready-to-use catheter assembly, or be arranged to keep the wetting fluid separated from the hydrophilic surface layer of the catheter during storage, but to be brought into contact with said hydrophilic surface layer upon activation before an intended use of the catheter. A similar method and wetting fluid is disclosed as well. The provision of the osmolality-increasing compound in the wetting fluid provides several advantages per se, such as a improved properties of the hydrophilic coating, a more predictable and controllable wetting process, a more expedient and cost efficient production, etc. Further, the use of this very high concentration of osmolality-increasing compound in the wetting fluid has proven remarkably efficient.