Biomaterial Assay Strip with Micropore Gradient for RBC Separation

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Solution Overview

Problem

Current strip-type platforms for point-of-care tests face challenges in efficiently separating red blood cells from blood, leading to poor accuracy and reproducibility, especially with high red blood cell content, and require large sample volumes, causing inconvenience and pain during collection.

Innovation Solution

A biomaterial assay strip with a porous matrix composed of polysulfone-based materials, including an enzyme and dye, featuring a structured micropore size gradient that facilitates efficient separation and color development, allowing for accurate measurement with a small sample volume using a portable terminal.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Measurement precision

If multiple glass fiber pads are overlapped to remove red blood cells, then red blood cell separation efficiency is improved, but sample volume requirement increases and collection becomes more difficult

Engineering Contradiction:
Improvered blood cell separation efficiencyVSAvoidsample volume
Core Design Contradiction:
Measurement precisionVSQuantity of substance

Solution Approach 1:

The patent employs a porous membrane with specifically controlled pore sizes (0.3-1.0 μm) to achieve red blood cell separation. The porous structure allows plasma to pass through while retaining red blood cells, eliminating the need for multiple glass fiber pads and reducing sample volume requirements.

Inventive Principle:
Principle #31Porous materials

Solution Approach 2:

The patent changes the pore size parameter of the membrane to optimize separation efficiency. By controlling pore sizes within 0.3-1.0 μm, the membrane effectively separates red blood cells from plasma, achieving high separation efficiency with minimal sample volume without requiring multiple layers of pads.

Inventive Principle:
Principle #35Parameter changes

2Productivity

If an anisotropic membrane with different pore sizes in upper and lower layers is used, then red blood cell separation and measurement are performed simultaneously, but red blood cells are not properly filtered in high Hct% cases causing staining and poor measurement accuracy

Engineering Contradiction:
Improvemeasurement speedVSAvoidmeasurement accuracy
Core Design Contradiction:
ProductivityVSMeasurement precision

Solution Approach 1:

The patent applies local quality by having different pore size distributions in different regions of the membrane. The upper surface has smaller pores (0.3-0.6 μm) for effective red blood cell filtration, while the lower surface has larger pores (0.6-1.0 μm) to prevent staining and allow proper plasma passage, achieving both high-speed separation and accurate measurement.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent uses a porous membrane with controlled pore size distribution to simultaneously achieve red blood cell separation and prevent staining. The specific pore size range (0.3-1.0 μm) allows the membrane to filter red blood cells effectively while preventing them from breaking and staining the lower layer, even in high Hct% samples.

Inventive Principle:
Principle #31Porous materials

3Ease of manufacture

If a porous membrane with uniform pore size is used, then manufacturing is simplified, but separation efficiency decreases and red blood cells break causing staining

Engineering Contradiction:
Improvemembrane fabrication simplicityVSAvoidseparation efficiency and measurement accuracy
Core Design Contradiction:
Ease of manufactureVSMeasurement precision

Solution Approach 1:

The patent implements local quality by creating a pore size gradient within the membrane structure. The upper portion has smaller pores (0.3-0.6 μm) for effective red blood cell retention, while the lower portion has larger pores (0.6-1.0 μm) to prevent staining. This localized differentiation maintains manufacturing simplicity while achieving high separation efficiency and measurement accuracy.

Inventive Principle:
Principle #3Local quality

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 strip enhances measurement efficiency, accuracy, and reproducibility by effectively separating biomaterials with a small sample volume, improving disease and health information acquisition while minimizing sample collection pain and equipment constraints.

Implementation Method 1

a porous matrix having micropores... the matrix includes an enzyme, a dye, and a hydrophilic polymer material, all of which react with a biomaterial

Methodology Applied
Scientific EffectFiltration: Filter (physical)

Implementation Method 2

the matrix includes an enzyme, a dye, and a hydrophilic polymer material, all of which react with a biomaterial

Methodology Applied
Scientific EffectEnzyme reaction: Enzyme

Implementation Method 3

measuring a change in color according to concentration, and the strip includes an upper layer part where the average size of the micropores gradually decreases

Methodology Applied
Scientific EffectColorimetric assay:

Data Source

PatentEP3995826B1Biomaterial assay strip
Publication Date: 2024.09.04 1DROP INC
  • EP3995826B1 patent drawingFigure 1~2
  • EP3995826B1 patent drawingFigure 3
  • EP3995826B1 patent drawingFigure 4

AI summary

The present invention provides a biomaterial assay strip as a strip-type platform for use in a point-of-care test device. The strip includes a porous matrix bearing micropores and composed of materials comprising a copolymer selected from the group comprising polysulfone, polyethersulfone, and polyarylsulfone in order to increase separation efficiency of the blood cells contained in a sample and to improve accuracy and reproducibility of measurements with a small amount of blood, wherein the matrix comprises an enzyme, a dye, and a hydrophilic polymer material therein, which all respond to a biomaterial and wherein the matrix develops a color as the biomaterial contained in the sample which is brought into contact with the upper layer of the matrix and then diffuses to the lower layer of the matrix, thereby assaying the biomaterial.