Clot Detection Using Disk Minimum Position Integration

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Solution Overview

Problem

Existing methods for detecting blood clots in coagulation tests, such as ACT, often result in false detections due to noise and variability in sensor readings, especially when dealing with weak clots or incomplete mixing of reagents, leading to inaccurate results.

Innovation Solution

The method involves evaluating changes in the Disk Minimum Position and integrating the Disk Minimum Position over a test period as additional or sole clot detection endpoints, rather than relying solely on drop time or velocity, to accurately detect clot formation at an early stage while minimizing false positives.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If clot detection sensitivity threshold is set low to detect weak clots, then early clot detection capability is improved, but false detections increase due to noise and reagent variability

Engineering Contradiction:
Improveclot detection sensitivityVSAvoidfalse detection rate
Core Design Contradiction:
Measurement precisionVSReliability

Solution Approach 1:

The patent segments the clot detection process into multiple independent parameters (drop time, drop velocity, Disk Minimum Position) instead of relying on a single threshold. By dividing the detection into separate measurable aspects, the system can evaluate each parameter's contribution to clot formation without any single parameter triggering false positives due to noise

Inventive Principle:
Principle #1Segmentation

Solution Approach 2:

The patent adds a new dimension to detection by introducing Disk Minimum Position evaluation and integration over time, moving beyond traditional single-point drop time measurements. This dimensional expansion allows the system to detect clot formation through cumulative changes rather than abrupt threshold crossings, reducing false detections while maintaining sensitivity

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

2Device complexity

If traditional drop time method is used for clot detection, then simplicity of detection is maintained, but false detections occur due to noise in sensor readings

Engineering Contradiction:
Improvedetection method simplicityVSAvoiddetection accuracy
Core Design Contradiction:
Device complexityVSReliability

Solution Approach 1:

The patent merges multiple detection parameters (drop time, drop velocity, Disk Minimum Position) into a unified clot detection evaluation system. By combining these parameters, the system maintains operational simplicity while achieving higher reliability through multi-parameter consensus rather than single-parameter thresholding

Inventive Principle:
Principle #5Merging (Combining)

Solution Approach 2:

The system incorporates feedback through integration of Disk Minimum Position over the test period, where cumulative position changes provide feedback on clot formation progress. This feedback mechanism allows the system to distinguish true clot formation from transient noise by requiring sustained positional changes over time

Inventive Principle:
Principle #23Feedback

3Measurement precision

If Disk Minimum Position evaluation is added as clot detection endpoint, then sensitivity to early clot formation is improved, but device complexity increases

Engineering Contradiction:
Improveearly clot detection accuracyVSAvoiddetection algorithm complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The Disk Minimum Position measurement serves multiple functions: it detects early clot formation, provides cumulative integration data for enhanced sensitivity, and acts as an independent verification parameter. This multi-functionality justifies the added computational complexity by delivering multiple detection benefits from a single measurement parameter

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

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 enhances the sensitivity of clot detection, reducing false positives and providing a more reliable assessment of clot formation, even in the presence of noise or reagent variability, thereby improving the accuracy of coagulation tests.

Implementation Method 1

a ferromagnetic disk is positioned at a Disk Maximum Position within a test chamber of a fluid viscosity testing device by magnetic force produced by a magnetic field

Methodology Applied
Scientific EffectMagnetic force: Magnetism

Implementation Method 2

the disk is then held at the Disk Maximum Position for a specified time. After the specified holding time, the magnetic force is released so that the disk falls through the fluid sample due to the force of gravity

Methodology Applied
Scientific EffectGravity: Gravitation

Implementation Method 3

The increased viscosity due to the clotting of the test sample slows the motion of the washer

Methodology Applied
Scientific EffectViscosity change: Viscometer

Data Source

PatentEP3682235B1Clot detection methods for clotting time testing
Publication Date: 2023.04.26 MEDTRONIC VASCULAR INC
  • EP3682235B1 patent drawingFigure 1~2
  • EP3682235B1 patent drawingFigure 3
  • EP3682235B1 patent drawingFigure 4A

AI summary

Aspects of the disclosure relate to blood clotting time tests detecting clotting time based on the viscosity changes of a fluid sample (200), using a disk (116) dropped within a test chamber (114) containing the fluid sample (200) from a disk maximal position to a disk minimal position, which is a point at which the disk settles within the fluid sample (200). Changes in the disk minimal position as multiple test cycles are conducted are used in assessing formation of a clot within the fluid sample (200). Methods of assessing such changes in the disk minimal position are disclosed.