Platelet Aggregation Assay Device with Dual Activator Channels

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Solution Overview

Problem

Current methods for determining platelet aggregation or inhibition due to anti-platelet drugs are expensive, time-consuming, and often require multiple assays or baseline measurements, making them unsuitable for clinical environments and unable to provide a single measurement of percent platelet inhibition from a single blood sample.

Innovation Solution

An assay device with multiple channels is used, where a first platelet activator sensitive to the anti-platelet drug's pathway and a second platelet activator insensitive to this pathway are introduced to the same blood sample, allowing simultaneous measurement of platelet aggregation in both channels, enabling the calculation of percent aggregation or inhibition using optical turbidimetric methods.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If traditional platelet aggregation assays are used, then platelet function can be assessed, but the process is expensive, time-consuming, and requires multiple assays or baseline measurements

Engineering Contradiction:
Improveplatelet aggregation measurement accuracyVSAvoidassay time and complexity
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The assay system is divided into multiple channels (first channel with first platelet activator, second channel with second platelet activator) that can process samples in parallel. This segmentation allows simultaneous measurement of platelet aggregation responses to different activators from the same blood sample, eliminating the need for sequential assays and baseline measurements while maintaining measurement precision.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The assay device is designed to perform multiple functions using a single blood sample: measuring platelet aggregation response to both a first platelet activator (sensitive to anti-platelet drug pathway) and a second platelet activator (insensitive to the pathway). This multi-functionality eliminates the need for multiple separate assays and baseline measurements, reducing time and cost while providing comprehensive platelet function assessment.

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

2Measurement precision

If multiple assays or baseline measurements are required, then accurate percent aggregation can be determined, but the process becomes cumbersome and unsuitable for clinical environments

Engineering Contradiction:
Improvepercent aggregation determination accuracyVSAvoidclinical suitability and operational simplicity
Core Design Contradiction:
Measurement precisionVSEase of operation

Solution Approach 1:

The system performs preliminary actions by simultaneously measuring platelet aggregation responses to both activators in the same initial blood sample, rather than requiring sequential assays or baseline measurements. The first channel measures response to the first platelet activator and the second channel measures response to the second platelet activator from the same sample, providing all necessary data for percent aggregation calculation in a single operational step, thereby simplifying clinical operation while maintaining accuracy.

Inventive Principle:
Principle #10Preliminary action

3Measurement precision

If centrifugation is performed to prepare PRP and PPP samples, then platelet aggregation can be measured, but hemolysis of red blood cells occurs causing errors in optical reference level

Engineering Contradiction:
Improveoptical reference level accuracyVSAvoidhemolysis and optical interference
Core Design Contradiction:
Measurement precisionVSObject-affected harmful factors

Solution Approach 1:

The invention extracts and eliminates the problematic centrifugation step from the assay protocol. By using undiluted whole blood directly in the assay channels, the method removes the source of hemolysis and optical interference that would otherwise occur during centrifugation. This extraction of the problematic process maintains measurement precision by avoiding the generation of hemolytic artifacts that would compromise the optical reference level.

Inventive Principle:
Principle #2Taking out (Extraction)

4Measurement precision

If diluted whole blood is used with electrical impedance measurement, then platelet aggregation can be assessed, but there is no single assay means to determine percent aggregation requiring two separate assays

Engineering Contradiction:
Improveplatelet aggregation measurementVSAvoidnumber of assays required
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The invention merges the measurement of platelet aggregation responses to different activators into a single assay system with multiple channels. The first channel measures aggregation response to the first platelet activator while the second channel simultaneously measures response to the second platelet activator using the same blood sample. This merging eliminates the need for two separate assays and provides a single comprehensive measurement system that determines percent aggregation without requiring sequential testing.

Inventive Principle:
Principle #5Merging (Combining)

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 allows for a rapid, single measurement of platelet inhibition from a single blood sample, providing accurate and efficient assessment of platelet function, even in patients on anti-platelet therapy, thereby improving clinical management and reducing errors associated with sample preparation variability.

Implementation Method 1

A level of platelet aggregation is simultaneously made in both channels by assay device 10. By way of illustration, and without limitation, the level of platelet aggregation can be determined by an optical turbidimetric method.

Methodology Applied
Scientific EffectOptical turbidimetry: Absorption (EM radiation)

Data Source

PatentEP1885873B1Method and system for absolute platelet percent aggregation determination
Publication Date: 2010.09.15 ACCUMETRICS INC
  • EP1885873B1 patent drawingFigure 1
  • EP1885873B1 patent drawing
  • EP1885873B1 patent drawing

AI summary

A method for obtaining a percent aggregation or inhibition of platelets resulting from anti-platelet using a single blood sample is achieved . An assay device is provided. The assay device has multiple channels, each coupled to a common introduction port. A first platelet activator is sensitive to activation pathway targeted by the anti-platelet drug. A second platelet activator is insensitive to the activation pathway targeted by the anti-platelet drug. An anti-coagulated sample is introduced simultaneously to the first and second channels. A level of platelet aggregation is simultaneously made in both channels.