Coagulation Analysis Apparatus Incubation Correction Test

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Solution Overview

Problem

Existing instruments for identifying prolonged coagulation time in blood samples are inconvenient to operate and have poor effectiveness, particularly in distinguishing between coagulation factor deficiency and coagulation factor inhibitors, which are difficult to identify through conventional coagulation time screening tests.

Innovation Solution

A sample analysis apparatus and method that incorporates a seventh coagulation item, allowing for an incubation correction test with an increased initial plasma sample amount, and different detection processes for immediate and incubation correction tests to improve identification of blood coagulation factor inhibitors.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If a conventional coagulation time screening test is used, then the test is simple and quick, but it cannot distinguish between coagulation factor deficiency and coagulation factor inhibitors

Engineering Contradiction:
Improveidentification accuracyVSAvoidtest complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The mixing plasma correction test is divided into multiple detection processes: immediate correction test and incubation correction test. Each test process includes multiple coagulation items (first, second, third, fourth, fifth, sixth, and seventh coagulation items) that are detected separately. This segmentation allows the system to distinguish between coagulation factor deficiency and inhibitors by comparing results across different time points and mixing ratios, thereby improving identification accuracy without overwhelming complexity in a single test.

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The system performs preliminary mixing of patient plasma with normal plasma at specific ratios (1:4 and 1:1) before detection. The incubation correction test involves preliminary incubation at 37°C for 2 hours before detection. These preliminary actions prepare the samples in controlled conditions that reveal different characteristics of coagulation factor deficiency versus inhibitors, enabling accurate distinction between the two conditions.

Inventive Principle:
Principle #10Preliminary action

2Ease of operation

If manual incubation is used for correction test, then the test can be performed, but it is inconvenient and has poor effectiveness

Engineering Contradiction:
Improveoperation convenienceVSAvoidtest effectiveness
Core Design Contradiction:
Ease of operationVSReliability

Solution Approach 1:

The sample analysis apparatus automatically performs the incubation correction test without requiring manual intervention. The system autonomously mixes patient plasma with normal plasma, incubates at 37°C for 2 hours, and detects coagulation time for multiple items. This automation eliminates the inconvenience of manual incubation while maintaining and improving test effectiveness through consistent, controlled conditions and multiple detection parameters.

Inventive Principle:
Principle #25Self-service

Solution Approach 2:

The manual mechanical incubation process is replaced by an automated thermal incubation system within the sample analysis apparatus. The system uses controlled temperature chambers and automated mixing mechanisms to perform incubation and detection, replacing manual operations with automated mechanical and thermal systems that provide more reliable and convenient testing.

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

3Reliability

If the initial plasma sample amount is increased for incubation correction test, then the test reliability is improved, but the plasma waste increases

Engineering Contradiction:
Improvetest reliabilityVSAvoidplasma waste
Core Design Contradiction:
ReliabilityVSLoss of substance

Solution Approach 1:

The system changes the parameter of plasma sample amount dynamically based on the test type. For immediate correction tests, smaller sample amounts are used, while for incubation correction tests, larger sample amounts are used to ensure reliability. The system also optimizes the mixing ratios (1:4 and 1:1) to maximize information extraction from each sample unit, reducing overall waste while maintaining test reliability through parameter optimization rather than simply increasing all sample amounts uniformly.

Inventive Principle:
Principle #35Parameter changes

4Measurement precision

If multiple coagulation items are detected in the mixing plasma correction test, then the identification accuracy is improved, but the test time increases

Engineering Contradiction:
Improveidentification accuracyVSAvoidtest time
Core Design Contradiction:
Measurement precisionVSLoss of time

Solution Approach 1:

The system performs multiple coagulation item detections continuously during the incubation period rather than sequentially. While the plasma sample is incubating at 37°C for 2 hours, the system prepares and detects multiple coagulation items (first through seventh items) using different mixing ratios and conditions. This continuous detection approach allows multiple measurements to be obtained without extending the total test time, as the incubation and detection processes overlap.

Inventive Principle:
Principle #20Continuity of useful action

Data Source

PatentEP4227687B1Sample analysis apparatus and sample analysis method
Publication Date: 2025.07.30 BEIJING SHEN MINDRAY MEDICAL ELECTRONICS TECH RES INST CO LTD
  • EP4227687B1 patent drawingFigure 1~2
  • EP4227687B1 patent drawingFigure 3
  • EP4227687B1 patent drawingFigure 4A~4B

AI summary

Provided are a sample analysis apparatus and a sample analysis method. The sample analysis method includes: aspirating a sample from a sample vessel containing normal plasma and dispensing the sample into a fifth buffer vessel for incubating for a preset duration under a preset condition; aspirating the incubated samples from a fourth buffer vessel and the fifth buffer vessel respectively, dispensing the samples into a seventh reaction vessel, and adding a reagent for determining a coagulation time to the seventh reaction vessel to prepare a seventh testing sample. By designing and introducing a seventh coagulation item into a full-automatic correction test, the invention has a very good effect on identifying, for example, a minute amount of blood coagulation factor inhibitor.