Disposable INR Measuring Stripe with Multi-Layer Capillary Structure

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Solution Overview

Problem

Current disposable devices for home self-checking of INR values are complex, costly to produce, and require reagents, making them unsuitable for mass production and use by non-experts, while also failing to ensure accurate results without artificial interference.

Innovation Solution

A disposable device with a multi-layered measuring stripe composed of absorbent and less absorbent celluloid materials, allowing for blood clotting measurement without reagents, featuring a capillary system that ensures continuous blood absorption and prevents false readings, with a simple structure for easy production and use.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If reagents are used in the measuring stripe to activate blood clotting, then the accuracy of INR measurement is improved, but the device complexity and production cost increase, and special expertise is required for operation

Engineering Contradiction:
ImproveINR measurement accuracyVSAvoiddevice structure complexity
Core Design Contradiction:
Measurement precisionVSDevice complexity

Solution Approach 1:

The patent removes reagents from the measuring stripe, extracting the complicating factor that required special expertise and complex production processes. Blood clotting is activated naturally through the capillary action and contact with the celluloid material itself, eliminating the need for chemical reagents while maintaining measurement capability

Inventive Principle:
Principle #2Taking out (Extraction)

Solution Approach 2:

The measuring stripe is designed to activate blood clotting automatically through its own structure and material properties (celluloid composition and capillary channels) without requiring external reagents or expert intervention. The system serves itself by using the physical properties of the material to initiate and control the clotting process

Inventive Principle:
Principle #25Self-service

2Ease of manufacture

If a single-layer absorbent material is used in the measuring stripe, then the production process is simplified, but blood absorption is inconsistent leading to false measurement results

Engineering Contradiction:
Improveproduction simplicityVSAvoidmeasurement reliability
Core Design Contradiction:
Ease of manufactureVSReliability

Solution Approach 1:

The measuring stripe uses a composite structure with multiple layers of celluloid material with different absorption properties. This composite construction ensures consistent blood absorption and reliable clotting activation while remaining compatible with mass production techniques. The layered structure compensates for variations in individual layers, improving overall reliability

Inventive Principle:
Principle #40Composite materials

Solution Approach 2:

Different regions of the measuring stripe have different absorption characteristics tailored to their specific functions. The multi-layer construction provides local variations in absorption rate and capacity, with each layer contributing to the overall reliability of blood sample processing and clotting activation

Inventive Principle:
Principle #3Local quality

3Productivity

If the measuring stripe structure is simplified for mass production, then production cost decreases, but the ability to ensure continuous blood absorption and prevent false readings is compromised

Engineering Contradiction:
Improvemass production capabilityVSAvoidcontinuous blood absorption assurance
Core Design Contradiction:
ProductivityVSReliability

Solution Approach 1:

The measuring stripe is divided into multiple functional layers, each with a specific role in blood absorption and clotting activation. This segmentation allows for standardized mass production of individual layers while ensuring that the complete multi-layer structure provides reliable continuous absorption and prevents false readings through the combined function of all layers

Inventive Principle:
Principle #1Segmentation

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 device allows for rapid, reliable, and accurate determination of INR values with minimal blood sample requirement, suitable for mass production, and can be used without special expertise, ensuring consistent and safe coagulation monitoring.

Implementation Method 1

the role of each blocked capillary tube can be taken over by several other capillary tubes at the same time, by which the continuous blood absorption is always assured until blood clotting

Methodology Applied
Scientific EffectCapillary action: Capillary Action

Implementation Method 2

an upper layer of which was made of absorbent material e.g. paper made of loose structured, veil-like celluloid fibres

Methodology Applied
Scientific EffectAbsorption: Absorption (physical)

Implementation Method 3

The further spread of the sample stops due to coagulation. The degree of spread is proportional to coagulation time

Methodology Applied
Scientific EffectCoagulation: Coagulation

Data Source

PatentEP2932261B1Disposable IVD device for home self-checking of INR value, characterising blood clotting
Publication Date: 2024.01.17 HAEMOTHROMB TEST KFT
  • EP2932261B1 patent drawingFigure 1
  • EP2932261B1 patent drawingFigure 2
  • EP2932261B1 patent drawingFigure 3~6

AI summary

The subject of the invention is a disposable IVD device for home measuring of INR value, characterising blood clotting, moreover in case of regular modification of blood clotting capacity in an artificial way e.g. taking medicine/medicines, for continuous monitoring of the induced change, e.g. in case of taking anticoagulants for determining INR value with blood absorbing material, with a device for measuring blood clotting distance comprising a measuring stripe (1), brought into contact with blood sample in the reservoir (10), attached to the lower plane (4) and braced between the distance mandrels (7) and distance pieces (5) protruding from two at least partly transparent planes: the lower plane (4) and the upper plane (6); An expediently chosen evaluation part (23), which is suitable for reading the boundary line of the clot on the measuring strite (1) off the INR value scale (15) it is supplied with in case of measuring the modification of the INR value of blood, The lower plane (4) and the upper plane (6) bracing the measuring stripe (1) are arranged at 0° < a < 90° angles to horizontal line; the measuring stripe (1) comprises at least two parts, the upper layer (2) and the lower layer (3); the upper layer (2) comprises absorbent material/materials e.g. one or two layers of veil, made of loose structured plant fibres or synthetic fibres or the orderly, veil-like heap of their mixture or paper, made of veil-like celluloid fibres, synthetic veil, blotting paper e.t.c.; the lower layer (3) comprises thicker, solid structured cardboard/cardboards with glossy and smooth surface, made of less absorbent celluloid basic material; the two or more upper layers and the at least one lower layer are joined by sticking at their ends; at least one more lower layer is stuck to the layers, fastened together at their ends in the way that the end of the stuck lower layer is placed at least 10 mm farther from the end of the measuring stripe facing the reservoir; 1st upper end is at least 3 mm shorter than the end of the fastened layers, placed over it; the free end of this lower layer is supported by a distant piece (5) or an insertion holding end (26), fixed to the end of the measuring stripe so that the end of the lower layer can slip in case of stretching.