Hemophilia Severity Determination via Coagulation Waveform Analysis

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Solution Overview

Problem

Current methods for determining the severity of hemophilia, particularly in patients with very-severe hemophilia A (VS-HA) and those with inhibitors, lack accuracy in distinguishing between different severities and the presence of antibodies against coagulation factors, making it difficult to manage hemostasis and select appropriate treatment policies.

Innovation Solution

A method involving coagulation of a blood specimen to acquire a coagulation waveform, calculating the average change rate of the coagulation rate based on the waveform's derivative, and using this metric to determine the severity of hemophilia, with a blood specimen analyzer configured to prepare samples, acquire waveforms, and output severity information.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If conventional coagulation tests are used to determine hemophilia severity, then basic coagulation status can be assessed, but accuracy in distinguishing between VS-HA patients and patients with inhibitors is insufficient

Engineering Contradiction:
Improveaccuracy in determining hemophilia severityVSAvoidcomplexity of coagulation analysis system
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent segments the coagulation curve analysis into multiple distinct parameters: coagulation time (T), maximum coagulation rate (dY/dt)max, and average coagulation rate. This segmentation allows each parameter to capture different aspects of coagulation function, enabling more precise differentiation between VS-HA patients and inhibitor-positive patients without requiring a completely new testing system.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent introduces a new dimension of analysis by calculating the average coagulation rate as an additional parameter beyond the conventional coagulation time and maximum rate. This adds a temporal dimension to the analysis, examining the rate of change throughout the entire coagulation process, which provides enhanced discriminatory power for severity classification.

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

2Measurement precision

If detailed coagulation waveform analysis is performed to improve severity determination accuracy, then differentiation between patient groups improves, but analysis time and computational complexity increase

Engineering Contradiction:
Improveaccuracy in distinguishing patient groupsVSAvoidtime for coagulation analysis
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The patent applies partial action by selecting specific key parameters (coagulation time, maximum rate, and average rate) from the complete coagulation waveform data. Rather than analyzing every aspect of the waveform, it focuses on the most discriminative features, achieving high accuracy while minimizing analysis time and computational requirements.

Inventive Principle:
Principle #16Partial or excessive action

Solution Approach 2:

The patent performs preliminary calculation of the average coagulation rate based on pre-defined time intervals and parameter ranges. This preliminary action prepares the data in advance for rapid comparison and classification, reducing the time needed for final severity determination while maintaining high precision.

Inventive Principle:
Principle #10Preliminary action

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 high-accuracy determination of severe hemophilia severity, including VS-HA and patients with inhibitors, allowing for more precise treatment policy selection by distinguishing between different severities and antibody presence.

Implementation Method 1

coagulating a blood specimen to acquire a coagulation waveform

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentEP3276356B1Method for determining severity of hemophilia and blood specimen analyzer
Publication Date: 2019.11.27 SYSMEX CORP
  • EP3276356B1 patent drawingFigure 1A~1B
  • EP3276356B1 patent drawingFigure 2~3
  • EP3276356B1 patent drawingFigure 4

AI summary

Disclosed is a method for determining the severity of hemophilia, the method including the steps of: coagulating a blood specimen to acquire a coagulation waveform; acquiring an average change rate of a coagulation rate from the coagulation waveform; and determining the severity of hemophilia in the blood specimen based on the average change rate of the coagulation rate.