Viscometer Coagulation Measurement Without Activators

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Solution Overview

Problem

Current methods for measuring coagulation haemostatic parameters in blood samples are limited by the use of artificial activators, non-physiological shear rates, and arbitrary units of measurement, which reduce the accuracy and comparability of results.

Innovation Solution

A method involving a viscometer that applies a physiological shear rate to a native blood sample without activators, allowing for dynamic and continuous measurement of coagulation parameters like time to gel point, maximum clot viscosity, and steady clot viscosity, expressed in directly comparable units.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Productivity

If artificial activators (kaolin, tissue factor) are added to stimulate coagulation, then the coagulation process can be measured, but the measurement conditions become non-physiological and platelet function assessment is compromised

Engineering Contradiction:

Improvecoagulation measurement speedVSAvoidphysiological accuracy

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The invention removes artificial activators from the measurement system, using only physiological activators already present in the blood sample. This extraction of harmful elements allows natural coagulation to proceed without non-physiological stimulation, resolving the contradiction between measurement speed and physiological accuracy.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The invention changes the measurement parameters by using physiological shear rates (0.5-2.0 sec^-1) that match in-vivo conditions, rather than arbitrary high shear rates. This parameter change enables accurate assessment of platelet function and coagulation dynamics under realistic physiological conditions.

Inventive Principle:

Principle #35Parameter changes

2Ease of operation

If high shear rates are applied to measure coagulation, then measurement can be performed, but the shear rate does not correspond to physiological conditions

Engineering Contradiction:

Improvemeasurement capabilityVSAvoidphysiological relevance

Core Design Contradiction:

Ease of operationVSMeasurement precision

Solution Approach 1:

The invention changes the shear rate parameter from arbitrary high values to physiological ranges (0.5-2.0 sec^-1), making the measurement conditions match in-vivo blood flow conditions. This enables accurate assessment of coagulation and platelet function under realistic physiological stress.

Inventive Principle:

Principle #35Parameter changes

3Ease of manufacture

If arbitrary units of measurement are used, then data can be represented graphically, but the units are not comparable to experimental viscosity data

Engineering Contradiction:

Improvedata representationVSAvoiddata comparability

Core Design Contradiction:

Ease of manufactureVSMeasurement precision

Solution Approach 1:

The invention replaces the mechanical measurement system (rotating sensor) with a microfluidic flow system that directly measures viscosity in standard units (cP). This substitution eliminates arbitrary units and provides direct comparability with other viscosity measurements while maintaining graphical data representation capabilities.

Inventive Principle:

Principle #28Mechanics substitution (Replace mechanical system)

4Productivity

If the blood sample is activated with kaolin or tissue factor, then coagulation can be stimulated, but platelet inhibitory drug effects cannot be properly assessed

Engineering Contradiction:

Improvecoagulation inductionVSAvoidplatelet function assessment

Core Design Contradiction:

ProductivityVSReliability

Solution Approach 1:

The invention removes artificial activators that cause non-physiological platelet activation. By using only physiological activators present in the patient's blood, the system can accurately assess the effect of platelet inhibitory drugs without the confounding effect of artificial activation.

Inventive Principle:

Principle #2Taking out (Extraction)

Solution Approach 2:

The blood sample activates coagulation through its own physiological mechanisms without external artificial activators. This self-service approach preserves the natural balance between pro-coagulant and anti-coagulant factors, enabling accurate assessment of platelet function and drug effects.

Inventive Principle:

Principle #25Self-service

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

Enables accurate, dynamic, and continuous exploration of the coagulation process, simulating physiological conditions and avoiding the use of activators, thus providing reliable and comparable data for clinical assessment.

Implementation Method 1

The viscometer is configured to apply to the blood sample a shear rate, which corresponds to a physiological shear rate

Methodology Applied

Scientific EffectShear rate: Shear Stress

Data Source

PatentUS20240003799A1Method of acquisition and analysis of coagulation haemostatic parameters of a blood sample

Publication Date: 2024.01.04 VISCOP SRL

AI summary

A method of acquisition and analysis of coagulation haemostatic parameters of a blood sample comprises: supply of at least one blood sample; preparation of at least one viscometer in contact with the blood sample; acquisition of a plurality of viscosity data of the blood sample during a coagulation haemostatic process; and calculation of at least one characteristic parameter of the coagulation haemostatic process depending on the density values measured, the parameter being selected from: time to gel point, maximum clot viscosity and steady clot viscosity.