Acid Violet 43 Staining Agent for Gastrointestinal Mucosa

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Solution Overview

Problem

Current gastrointestinal mucosa staining agents, such as indigo carmine, methylene blue, and Lugol's iodine, face issues with stability, safety, and effectiveness due to color discrepancies, adverse reactions, cumbersome preparation, and instability, leading to suboptimal visualization and detection during endoscopy.

Innovation Solution

A staining agent comprising acid violet 43, optionally combined with allure red and an antioxidant like citric acid, is developed, providing improved stability, safety, and rinsing performance, with a concentration range of 0.01-5% for acid violet and 0.01-2.5% for allure red, packaged in a sealed brown bottle to enhance shelf life and visualization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If indigo carmine is used for staining, then the staining effect is enhanced through physical deposition, but the color discrepancy with the digestive tract causes an unclear staining visual field

Engineering Contradiction:
Improvestaining effectVSAvoidvisual field clarity
Core Design Contradiction:
ReliabilityVSIllumination intensity

Solution Approach 1:

The patent changes the staining agent color from blue (indigo carmine) to red (acid violet 43). The red color provides better contrast with the gastrointestinal mucosa, improving visual field clarity while maintaining effective staining. This color change resolves the contradiction between staining effectiveness and visual clarity.

Inventive Principle:
Principle #32Color changes

2Illumination intensity

If methylene blue is used for staining, then the mucosa turns blue for visualization, but it cannot be rinsed and requires re-staining, and may cause adverse reactions

Engineering Contradiction:
Improvemucosa visualizationVSAvoidrinsing and re-staining
Core Design Contradiction:
Illumination intensityVSEase of operation

Solution Approach 1:

The patent employs a staining agent (acid violet 43) that is designed for single-use and easy removal, unlike methylene blue which persists on the mucosa. The red staining agent can be completely rinsed off after observation, eliminating the need for re-staining and reducing operational complexity.

Inventive Principle:
Principle #27Cheap short-living objects (Disposable)

3Reliability

If Lugol's iodine is used at 5% concentration, then staining is effective, but the preparation is cumbersome and concentration accuracy is difficult to maintain

Engineering Contradiction:
Improvestaining effectivenessVSAvoidpreparation convenience
Core Design Contradiction:
ReliabilityVSEase of manufacture

Solution Approach 1:

The patent changes the concentration parameter from 5% (Lugol's iodine) to a much lower 0.01-5% range for acid violet 43. This parameter change maintains effective staining while dramatically simplifying preparation procedures and improving concentration accuracy, as lower concentrations are easier to prepare precisely and store stably.

Inventive Principle:
Principle #35Parameter changes

4Ease of operation

If indigo carmine is stored at room temperature, then it is readily available, but it undergoes redox reaction with oxygen and becomes unstable

Engineering Contradiction:
ImproveavailabilityVSAvoidchemical stability
Core Design Contradiction:
Ease of operationVSStability of the object's composition

Solution Approach 1:

The patent creates a protective environment for the staining agent by adding antioxidants (vitamin C, vitamin E, or sodium metabisulfite) that prevent oxidation reactions. This effectively creates a chemically inert environment that protects acid violet 43 from degrading through redox reactions with atmospheric oxygen, maintaining stability during storage.

Inventive Principle:
Principle #39Inert atmosphere (Inert environment)

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 proposed staining agent offers better safety, stability, and rinsing performance compared to existing agents, providing a clearer visualization with improved staining effects at lower concentrations and extended shelf life, while avoiding adverse reactions and oxidation.

Implementation Method 1

The principle of action of the indigo carmine staining agent is to perform staining comparison by means of physical deposition

Methodology Applied
Scientific EffectPhysical deposition: Deposition (physical)

Implementation Method 2

Methylene blue staining is to make a mucosa turn blue by absorbing the methylene blue by the mucosa

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 3

after the methylene blue is absorbed, human hemoglobin may become methemoglobin

Methodology Applied
Scientific EffectOxidation: Oxidation

Implementation Method 4

the indigo carmine staining agent is unstable in properties, and may undergo a redox reaction with oxygen in air at a room temperature

Methodology Applied
Scientific EffectOxidation prevention: Oxidation

Data Source

PatentEP4442284A1Staining agent for gastrointestinal mucosa and preparation method therefor
Publication Date: 2024.10.09 BEIJING COMPONT MEDICAL DEVICES CO LTD
  • EP4442284A1 patent drawingFigure 1~3
  • EP4442284A1 patent drawingFigure 4~6
  • EP4442284A1 patent drawingFigure 7~8

AI summary

The present invention provides a staining agent for gastrointestinal mucosa, including acid violet 43. Compared with existing commercially available staining agent products, the staining agent for gastrointestinal mucosa provided by the present invention has better safety, rinsing performance and stability. It is not susceptible to oxidation and decomposition under conventional conditions, and may provide a longer shelf life. Meanwhile, its staining effect is better than those of commercially available staining agent products at a low concentration.