Cytological Staining Solution for Uniform Biological Sample Processing

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Solution Overview

Problem

Existing cytological staining methods often result in poor staining quality, requiring large volumes of processing fluids and leading to non-specific staining and high variability in specimen preparation.

Innovation Solution

A cytological staining solution comprising Eosin Y, bis-tris or phosphate buffer, polysorbate 20, sodium chloride, ethylene glycol, and an antimicrobial agent, optimized for rapid and uniform specimen preparation with minimal fluid usage.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Manufacturing precision

If conventional cytological staining methods are used, then staining can be achieved, but staining quality is poor and non-specific staining occurs

Engineering Contradiction:
Improvestaining qualityVSAvoidspecificity of staining
Core Design Contradiction:
Manufacturing precisionVSReliability

Solution Approach 1:

The patent modifies the chemical parameters of the staining solution by incorporating specific concentrations of polysorbate 20 (0.01-10%), ethylene glycol (5-50%), and controlled pH levels (5.8-6.2). These parameter changes optimize the staining mechanism to achieve high-contrast, specific staining while reducing non-specific binding, directly resolving the contradiction between staining quality and staining specificity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The staining solution uses a composite formulation combining multiple agents: Eosin Y dye, polysorbate 20 surfactant, ethylene glycol, buffer salts, and antimicrobial agents. This composite material approach creates a synergistic effect where each component contributes to specific staining characteristics, improving both staining quality and specificity simultaneously.

Inventive Principle:
Principle #40Composite materials

2Productivity

If conventional staining methods are used, then specimens can be processed, but large volumes of processing fluids are required

Engineering Contradiction:
Improvespecimen processing capabilityVSAvoidfluid consumption
Core Design Contradiction:
ProductivityVSLoss of substance

Solution Approach 1:

The patent optimizes the concentration parameters of staining components to enhance staining efficiency. By adjusting the concentration of Eosin Y (0.5-5.0 g/L), polysorbate 20 (0.01-10%), and other components, the solution achieves effective staining with reduced fluid volumes, thereby maintaining productivity while reducing substance loss.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a highly efficient staining formulation that replicates the effectiveness of conventional large-volume processing with minimal fluid quantities. The optimized formula allows the same staining results to be achieved using significantly less fluid, addressing both productivity and fluid consumption concerns.

Inventive Principle:
Principle #26Copying

3Productivity

If conventional staining methods are used, then specimens can be prepared, but high variability in specimen preparation occurs

Engineering Contradiction:
Improvespecimen preparation speedVSAvoiduniformity of staining
Core Design Contradiction:
ProductivityVSManufacturing precision

Solution Approach 1:

The patent establishes controlled parameter ranges including pH (5.8-6.2), temperature (room temperature operation), and specific concentrations of staining components. These controlled parameters ensure consistent, uniform staining results across multiple specimens, eliminating variability while maintaining rapid processing speeds.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent introduces polysorbate 20 as an intermediary surfactant that mediates between the staining dye and biological specimens. This intermediary component ensures uniform distribution and consistent staining patterns, reducing variability while maintaining processing efficiency.

Inventive Principle:
Principle #24Intermediary (Mediator)

4Ease of manufacture

If conventional staining solutions are used, then staining can be performed, but operational costs and waste increase

Engineering Contradiction:
Improvestaining process simplicityVSAvoidfluid waste
Core Design Contradiction:
Ease of manufactureVSLoss of substance

Solution Approach 1:

The patent optimizes the concentration parameters to reduce the total volume of staining solution required. By adjusting Eosin Y concentration (0.5-5.0 g/L), polysorbate 20 (0.01-10%), and other components, the formulation achieves effective staining with minimal fluid consumption, thereby reducing operational costs and waste while maintaining process simplicity.

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The patent creates a cost-efficient staining formulation that replicates the effectiveness of expensive conventional solutions using cheaper components in optimized concentrations. The formula uses readily available materials like Eosin Y, polysorbate 20, and common buffers, reducing material costs while minimizing waste through reduced fluid volumes.

Inventive Principle:
Principle #26Copying

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 enables high-contrast, selective staining of biological samples with low fluid consumption, achieving rapid and uniform processing of specimens while reducing operational costs and waste.

Implementation Method 1

a cytological staining solution consisting of about 0.5 g/L to about 5.0 g/L Eosin Y

Methodology Applied
Scientific EffectStaining:

Implementation Method 2

about 0.5 mL/L to about 2.0 mL/L polysorbate 20

Methodology Applied
Scientific EffectSurfactant action: Surfactant

Implementation Method 3

about five mL/L to about 50 mL/L ethylene glycol

Methodology Applied
Scientific EffectChemical inhibition:

Implementation Method 4

about 5 mM to about 250 mM bis-tris or phosphate buffer, wherein the solution has a pH of from about 5.8 to about 6.2

Methodology Applied
Scientific EffectpH buffering:

Implementation Method 5

about 0.2 ppm to about 50 ppm of an antimicrobial agent

Methodology Applied
Scientific EffectAntimicrobial action: Preservative

Data Source

PatentEP4086605B1Solution and method for histoprocessing of biological samples
Publication Date: 2025.06.11 ROCHE DIAGNOSTICS HEMATOLOGY INC
  • EP4086605B1 patent drawingFigure 1
  • EP4086605B1 patent drawingFigure 2
  • EP4086605B1 patent drawingFigure 3

AI summary

The formulations, systems, and methods disclosed herein permit automated preparation of specimens (e.g., biological specimens) for examination. The disclosed formulations, systems, and methods provide fast, efficient, and highly uniform specimen processing using minimal quantities of fluids. The methods include at least a fixing phase for fixing a specimen to a substrate such as a microscope slide, a staining phase for staining the specimen, and a rinsing phase for rinsing the specimen. One or more of the fixing, staining, and rinsing phases include one or more agitation phases for distributing reagents evenly and uniformly across the specimen. The systems can be implemented as a standalone device or as a component in a larger system for preparing and examining specimens.