Blood Coagulation Kinetics Analysis for Severe Bleeding Detection

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Solution Overview

Problem

Existing methods for determining the severity of hemophilia A based on factor VIII activity levels fail to detect patients who may experience severe bleeding, as they rely on correlations with template samples and do not account for individual variations in coagulation kinetics.

Innovation Solution

An analysis method that involves obtaining time-series data sets of blood coagulation reactions to determine maximum speed and acceleration arrival times, along with reference times, to assess bleeding tendency by calculating a value (S) that reflects the speed of coagulation progression, enabling detection of individuals at risk of severe bleeding.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If FVIII activity level measurement is used to determine hemophilia A severity, then the measurement process is simple and quick, but it fails to detect patients who may experience severe bleeding

Engineering Contradiction:
Improvedetection accuracy of bleeding riskVSAvoidcomplexity of coagulation analysis
Core Design Contradiction:
ReliabilityVSDevice complexity

Solution Approach 1:

The coagulation reaction curve is segmented into multiple time regions (first region before maximum speed, second region at maximum speed, third region after maximum speed). By dividing the continuous curve into discrete segments and analyzing specific parameters in each segment, the method extracts detailed kinetic information that reveals bleeding risk patterns not visible in overall FVIII activity measurements.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The invention transitions from a single-dimension FVIII activity level measurement to a multi-dimensional analysis by examining multiple parameters (maximum coagulation speed, maximum acceleration, deceleration, and their arrival times) across different time regions of the coagulation curve. This dimensional expansion enables detection of subtle kinetic variations that indicate bleeding tendency.

Inventive Principle:
Principle #17Another dimension (Dimensionality change)

2Measurement precision

If template sample correlation method is used to determine hemophilia severity, then the analysis can be standardized, but it cannot detect individual variations in coagulation kinetics

Engineering Contradiction:
Improveprecision of bleeding tendency assessmentVSAvoidtime for coagulation curve analysis
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The method pre-establishes reference ranges for coagulation kinetic parameters (maximum speed arrival time, maximum acceleration arrival time, deceleration patterns) based on normal and abnormal coagulation profiles. By having these reference criteria prepared in advance, the actual patient analysis can quickly compare their kinetic parameters against these predetermined standards, achieving both precision and efficiency.

Inventive Principle:
Principle #10Preliminary action

Solution Approach 2:

Instead of comparing patients to template samples of known severity, the invention creates an idealized reference coagulation curve representing normal kinetics, then measures deviations from this reference. This copying approach establishes a universal standard that captures individual variations while maintaining analytical consistency across different patients.

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 method accurately identifies patients with a high bleeding tendency that may not be detected by conventional FVIII activity level measurements, providing a more precise assessment of bleeding risk.

Implementation Method 1

a coagulation reaction curve obtained from a blood sample

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentUS12436157B2Analysis method, analysis device, analysis system, and analysis program for analyzing a bleeding tendency of a subject
Publication Date: 2025.10.07 SYSMEX CORP
  • US12436157B2 patent drawing
  • US12436157B2 patent drawing
  • US12436157B2 patent drawing

AI summary

PROBLEM: According to the present invention, a patient who experiences severe bleeding is detected based on a value obtained by a common coagulation test.SOLUTION: The present invention is an analysis method for analyzing the bleeding tendency of a subject, and the problem is resolved by this analysis method which includes obtaining a time-series data set of a coagulation reaction of a blood sample collected from the subject; obtaining, based on the time-series data set, a maximum speed arrival time until a coagulation reaction speed is maximized or a maximum acceleration arrival time until a coagulation reaction acceleration is maximized, and a reference time in the coagulation reaction; obtaining a value based on the maximum speed arrival time or the maximum acceleration arrival time, and the reference time; and outputting the value or information relating to the bleeding tendency based on the value.