Spatially Separated Coagulation Reagent Pellets for Diagnostic Stability

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Solution Overview

Problem

Current viscoelastic analysis methods for blood coagulation face challenges with complex reagent handling, instability, and error-prone pipetting steps, leading to inconsistent and time-consuming measurements.

Innovation Solution

A diagnostic composition comprising spatially separated pellets of coagulation activators, calcium salts, and inhibitors, which are dissolved in the blood sample, simplifying the process to four pipetting steps and enhancing stability and standardization.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Ease of operation

If multiple reagents are mixed in liquid form before use, then the analysis can be performed, but the handling becomes complex and error-prone with multiple pipetting steps

Engineering Contradiction:
Improvereagent handlingVSAvoidpipetting steps
Core Design Contradiction:
Ease of operationVSDevice complexity

Solution Approach 1:

The reagent composition is segmented into spatially separated dry pellets within the container. Each pellet contains a specific reagent component (activator, calcium salt, inhibitor) that remains separate until contact with the blood sample. This segmentation eliminates the need for multiple liquid handling steps while maintaining the functional integrity of each component.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The reagents are transformed from liquid phase to dry solid phase (pellets). This parameter change from liquid to solid state allows the reagents to be stored stably and handled simply as discrete units that dissolve automatically upon contact with the blood sample, eliminating complex liquid handling procedures.

Inventive Principle:
Principle #35Parameter changes

2Stability of the object's composition

If reagents are stored in liquid form, then they are ready for use, but their stability decreases over time

Engineering Contradiction:
Improvereagent stabilityVSAvoidreagent preparation
Core Design Contradiction:
Stability of the object's compositionVSEase of manufacture

Solution Approach 1:

The reagents undergo a phase transition from liquid to dry solid state for storage. The dry pellets are stable over long periods and only transition back to dissolved state when the blood sample is added, ensuring both stability during storage and readiness for use without complex preparation.

Inventive Principle:
Principle #36Phase transitions

Solution Approach 2:

The reagents are prepared in advance as dry pellets and stored in the container ready for use. This preliminary preparation in stable dry form eliminates the need for complex liquid handling and mixing procedures at the time of analysis, while maintaining long-term stability.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If reagents are mixed in substance mixture form, then all components are available, but reproducibility decreases due to handling errors

Engineering Contradiction:
ImprovereproducibilityVSAvoidhandling simplicity
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The reagent components are segmented into separate dry pellets within the container rather than mixed together. This spatial separation ensures that each component is delivered in precise, predetermined amounts when the blood sample dissolves all pellets simultaneously, eliminating variability from manual mixing while maintaining handling simplicity.

Inventive Principle:
Principle #1Segmentation

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

This approach reduces handling errors, improves reproducibility, and provides a standardized system for determining coagulation characteristics with improved long-term stability and ease of use.

Implementation Method 1

A diagnostic composition comprising spatially separated pellets of coagulation activators, calcium salts, and inhibitors, which are dissolved in the blood sample

Methodology Applied
Scientific EffectDissolution: Solvation

Data Source

PatentEP3002591B1Composition for the determination of coagulation characteristics of a test liquid
Publication Date: 2020.05.06 C A CASYSO GMBH
  • EP3002591B1 patent drawingFigure 1
  • EP3002591B1 patent drawingFigure 2
  • EP3002591B1 patent drawingFigure 3

AI summary

The present invention is directed to a diagnostic composition for use in the viscoelastic analysis of a test liquid, and to a container (1) comprising same. The composition comprises at least an activator of coagulation, and, optionally CaCl2 and, optionally, one or more inhibitors and/or coagulation components, wherein the composition is present in essentially dry form of all constituents and in an amount sufficient for performing one single viscoelastic analysis of a specified blood or plasma sample and wherein the constituents are not present in a substance mixture, but in a spatially separated form. The present invention is further directed to a method of performing a viscoelastic analysis on a test liquid, and to the use of the diagnostic composition in such a method.