Standardizing Platelet Function Measurement Across PFA Cell Types

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Solution Overview

Problem

Current methods for determining platelet function using the Platelet Function Analyzer System (PFA) yield non-standardized results due to variations in measuring cell types, making it difficult to compare measurements across different cells.

Innovation Solution

Standardizing platelet function measurement by determining the sample volume that passes through the separating element within a defined time interval and comparing it to a reference sample volume value for normal platelet function, using formulas PHC1 and PHC2 to normalize results regardless of measuring cell type.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If different types of measuring cells are used in platelet function analysis, then the system can examine various platelet activation pathways, but the measurement results become non-standardized and difficult to compare

Engineering Contradiction:
Improveability to examine different platelet activation pathwaysVSAvoidstandardization of measurement results
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent applies parameter changes by introducing a normalization parameter (reference value) that transforms the raw closure time measurements into standardized platelet function values. Different measuring cell types produce different closure times, but by dividing each closure time by its corresponding reference value, the results are normalized to a common scale, enabling comparison across different cell types while maintaining the ability to examine various platelet activation pathways.

Inventive Principle:
Principle #35Parameter changes

2Reliability

If closure time is used as the measurement parameter, then platelet function can be assessed, but the closure time values differ significantly across measuring cell types making direct comparison difficult

Engineering Contradiction:
Improveplatelet function assessmentVSAvoidcomparability of closure time values
Core Design Contradiction:
ReliabilityVSMeasurement precision

Solution Approach 1:

The patent replaces the direct mechanical measurement of closure time with a calculated derived value (platelet function value). Instead of comparing raw closure times directly, the system substitutes them with normalized values calculated by dividing closure time by reference values. This substitution transforms the measurement into a standardized metric that maintains reliability for platelet function assessment while eliminating the comparability issues of raw closure times across different cell types.

Inventive Principle:
Principle #28Mechanics substitution (Replace mechanical system)

3Adaptability or versatility

If measuring cells with different activator combinations are used, then specific platelet activation pathways can be targeted, but the reference ranges become cell-type specific reducing overall standardization

Engineering Contradiction:
Improvetargeting specific platelet activation pathwaysVSAvoidstandardization across cell types
Core Design Contradiction:
Adaptability or versatilityVSMeasurement precision

Solution Approach 1:

The patent achieves universality by creating a standardized reference framework that applies across all measuring cell types. Each cell type has its own reference value determined from healthy donor samples, but these reference values are used to normalize results from all cell types to a common scale. This allows the system to maintain the ability to target specific activation pathways with different cell types while achieving overall standardization through the unified normalization approach.

Inventive Principle:
Principle #6Universality (Multi-functionality)

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 ensures that platelet function test results are directly comparable across all types of measuring cells, with results below 100% indicating reduced function and above 100% indicating increased function, thereby standardizing normal ranges and improving diagnostic accuracy.

Implementation Method 1

a negative pressure of around -40 mbar is generated in a PFA measuring cell

Methodology Applied
Scientific EffectNegative pressure: Pressure Gradient

Implementation Method 2

As a result of the induced adhesion and aggregation of the platelets, a platelet clot (thrombus) forms in the area of the aperture, which closes the membrane opening and stops the blood flow

Methodology Applied
Scientific EffectPlatelet aggregation: Coagulation

Data Source

PatentEP2543998B1Method for standardising measurement results in a system for measuring thrombocyte function
Publication Date: 2014.10.29 SIEMENS HEALTHCARE DIAGNOSTICS PRODS
  • EP2543998B1 patent drawingFigure 1
  • EP2543998B1 patent drawingFigure 2
  • EP2543998B1 patent drawingFigure 3

AI summary

The invention lies in the field of coagulation diagnostics and relates to in vitro methods for determining platelet function using measuring cells, in particular measuring cells of the PFA system. The methods enable the obtaining of standardized measurement results that are comparable regardless of the type of measuring cell used.