WO2024116740A1 - シート状構造物及びその使用方法 - Google Patents

シート状構造物及びその使用方法 Download PDF

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Publication number
WO2024116740A1
WO2024116740A1 PCT/JP2023/039971 JP2023039971W WO2024116740A1 WO 2024116740 A1 WO2024116740 A1 WO 2024116740A1 JP 2023039971 W JP2023039971 W JP 2023039971W WO 2024116740 A1 WO2024116740 A1 WO 2024116740A1
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WO
WIPO (PCT)
Prior art keywords
flow path
sheet
porous structure
flow
fluid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2023/039971
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English (en)
French (fr)
Japanese (ja)
Inventor
卓也 文珠
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Dexerials Corp
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Dexerials Corp
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Filing date
Publication date
Application filed by Dexerials Corp filed Critical Dexerials Corp
Priority to CN202380079665.3A priority Critical patent/CN120225883A/zh
Priority to KR1020257015036A priority patent/KR20250087620A/ko
Priority to EP23897394.5A priority patent/EP4628902A1/en
Publication of WO2024116740A1 publication Critical patent/WO2024116740A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502707Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the manufacture of the container or its components
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5027Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip
    • B01L3/502746Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip characterised by the means for controlling flow resistance, e.g. flow controllers, baffles
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B3/00Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form
    • B32B3/26Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer
    • B32B3/266Layered products comprising a layer with external or internal discontinuities or unevennesses, or a layer of non-planar shape; Layered products comprising a layer having particular features of form characterised by a particular shape of the outline of the cross-section of a continuous layer; characterised by a layer with cavities or internal voids ; characterised by an apertured layer characterised by an apertured layer, the apertures going through the whole thickness of the layer, e.g. expanded metal, perforated layer, slit layer regular cells B32B3/12
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B32LAYERED PRODUCTS
    • B32BLAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B5/00Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts
    • B32B5/18Layered products characterised by the non- homogeneity or physical structure, i.e. comprising a fibrous, filamentary, particulate or foam layer; Layered products characterised by having a layer differing constitutionally or physically in different parts characterised by features of a layer of foamed material
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54306Solid-phase reaction mechanisms
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N37/00Details not covered by any other group of this subclass
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0809Geometry, shape and general structure rectangular shaped
    • B01L2300/0816Cards, e.g. flat sample carriers usually with flow in two horizontal directions
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0809Geometry, shape and general structure rectangular shaped
    • B01L2300/0825Test strips
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0861Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0874Three dimensional network
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0861Configuration of multiple channels and/or chambers in a single devices
    • B01L2300/0877Flow chambers
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/08Geometry, shape and general structure
    • B01L2300/0887Laminated structure
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/12Specific details about materials
    • B01L2300/126Paper
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00Additional constructional details
    • B01L2300/16Surface properties and coatings
    • B01L2300/161Control and use of surface tension forces, e.g. hydrophobic, hydrophilic
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01LCHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00Moving or stopping fluids
    • B01L2400/04Moving fluids with specific forces or mechanical means
    • B01L2400/0403Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406Moving fluids with specific forces or mechanical means specific forces capillary forces
    • GPHYSICS
    • G01MEASURING; TESTING
    • G01NINVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366Apparatus specially adapted for solid-phase testing
    • G01N33/54386Analytical elements
    • G01N33/54387Immunochromatographic test strips
    • G01N33/54388Immunochromatographic test strips based on lateral flow

Definitions

  • the present invention relates to a sheet-like structure and a method for using the same.
  • testing devices In daily life and clinical settings, progress is being made in the development of testing devices that enable simple and rapid diagnosis. Pregnancy tests are a typical example of testing devices.
  • a test liquid containing a target substance such as an antigen
  • the test liquid flows through a flow path within the testing device.
  • a labeling medium such as an antibody that has been placed in the flow path beforehand reacts with the target substance in the test liquid, developing a color (developing color), and the presence of the target substance can be confirmed.
  • Test chips which are an example of testing devices, are sometimes called " ⁇ -PADs (microfluidic paper-based analytical devices)" and have many advantages, including (1) low cost, (2) pumpless, (3) no need for large-scale equipment, and (4) easy disposal, and research into improving them is ongoing worldwide.
  • ⁇ -PADs microfluidic paper-based analytical devices
  • test devices Various types of test chips (test devices) have already been reported.
  • a test device has been proposed in which liquid absorbing pads (paper disks) are provided between each layer of the multiple paper chips that make up the test device in order to ensure sufficient reaction time between the phosphorus-based pesticide sample and acetylcholine esterase (AChE) that reacts with the phosphorus-based pesticide, thereby providing a device with stronger color reaction intensity and higher accuracy (see Non-Patent Document 1).
  • This test device ensures reaction time between the sample and AChE by utilizing the delay in liquid flow caused by the liquid absorbing pads.
  • a test chip has been proposed in which a three-dimensional flow path is formed in a single sheet-like material in order to significantly suppress uneven color development (see Patent Document 1).
  • the liquid flows without having undergone a sufficient primary reaction (reaction between the sample and AChE), and since multiple substrates with flow paths formed therein are attached with double-sided tape, it is necessary to fill the gaps between the substrates that are equal to the thickness of the double-sided tape, and there are concerns that the assembly process is complicated.
  • the liquid flows quickly and the reaction time in the primary reaction cannot be sufficiently secured, so the sample and testing reagent (e.g., antigen and antibody) must be mixed in advance and reacted before being added. At this time, there is room for improvement in terms of disposal of the containers used for mixing and reaction, contamination of the sample, simplicity, etc.
  • the present invention aims to solve the above-mentioned problems in the past and achieve the following objectives. That is, the present invention aims to provide a sheet-like structure that can ensure sufficient reaction time and improve the accuracy of quantitative analysis.
  • the means for solving the above problems are as follows.
  • the porous structure layer has at least a part of a flow path having a porous structure through which a fluid can flow, exposed on a surface thereof, and a support layer.
  • the sheet-like structure is characterized in that the flow paths have separation parts capable of separating adjacent flow paths to block the flow of the fluid in the flow paths.
  • the separation portion is a cutting portion that cuts the flow path in a direction intersecting a flow direction of the fluid in the flow path.
  • ⁇ 3> The sheet-like structure according to ⁇ 1> or ⁇ 2>, wherein at least a part of the flow path exposed on the surface serves as a fluid receiving portion.
  • ⁇ 4> The sheet-like structure described in ⁇ 3>, wherein the separation portion separates the fluid receiving portion from the flow path adjacent to the fluid receiving portion, thereby blocking the fluid received in the fluid receiving portion from flowing to the flow path adjacent to the fluid receiving portion.
  • ⁇ 5> The sheet-like structure according to the item ⁇ 3> or ⁇ 4>, wherein the support layer is disposed in an area of the porous structure layer where the fluid receiving portion is not located.
  • ⁇ 6> The sheet-like structure according to any one of ⁇ 1> to ⁇ 5>, wherein the support layer is water-impermeable.
  • ⁇ 7> The sheet-like structure according to any one of ⁇ 1> to ⁇ 6>, wherein an exposed shape of the flow path exposed on one surface of the porous structure layer is different from an exposed shape of the flow path exposed on the other surface of the porous structure layer.
  • ⁇ 8> The sheet-like structure according to any one of ⁇ 3> to ⁇ 5>, wherein at least a portion of the flow path exposed on the surface is a detection portion, and the detection portion is arranged at a position in the flow path different from the fluid receiving portion.
  • ⁇ 9> A method for using the sheet-like structure according to any one of ⁇ 1> to ⁇ 8>, a first flow path is provided on one side of the separation section, and the first flow path and the second flow path are separated at the separation section to block the flow of the fluid so that the fluid received in the first flow path does not flow into a second flow path on the other side of the separation section;
  • This method of using a sheet-like structure is characterized in that after a certain period of time has elapsed, the first flow path and the second flow path are brought into contact with each other in the separation section, thereby allowing the fluid to circulate between the first flow path and the second flow path.
  • the present invention provides a sheet-like structure that ensures sufficient reaction time and improves the accuracy of quantitative analysis.
  • FIG. 1A is a schematic perspective view of a sheet-like structure according to a first embodiment.
  • FIG. 1B is a schematic cross-sectional view of the sheet-like structure of FIG. 1A taken along line aa'.
  • FIG. 2A is an explanatory diagram for explaining the function of the separation unit.
  • FIG. 2B is an explanatory diagram for explaining another function of the separation unit.
  • FIG. 3A is an explanatory diagram for explaining an example of the distribution of the support layer.
  • FIG. 3B is an explanatory diagram for explaining another example of the distribution of the support layer.
  • FIG. 3C is an explanatory diagram for explaining still another example of the distribution of the support layer.
  • FIG. 4A is a schematic cross-sectional view of a sheet-like structure according to a second embodiment.
  • FIG. 4A is a schematic cross-sectional view of a sheet-like structure according to a second embodiment.
  • FIG. 4B is a schematic plan view of the porous structure layer of FIG. 4A when viewed from the ⁇ direction.
  • FIG. 4C is a schematic plan view of the porous structure layer of FIG. 4A when viewed from the ⁇ direction.
  • FIG. 5A is a schematic cross-sectional view of a sheet-like structure according to a third embodiment.
  • FIG. 5B is a schematic plan view of the porous structure layer of FIG. 5A when viewed from the ⁇ direction.
  • FIG. 5C is a schematic plan view of the porous structure layer of FIG. 5A when viewed from the ⁇ direction.
  • FIG. 6A is a schematic cross-sectional view of a sheet-like structure according to a fourth embodiment.
  • FIG. 6B is a schematic plan view of the porous structure layer of FIG.
  • FIG. 6A when viewed from the ⁇ direction.
  • FIG. 6C is a schematic plan view of the porous structure layer of FIG. 6A when viewed from the ⁇ direction.
  • FIG. 7A is a schematic plan view of a porous structure layer in a sheet-like structure of the fifth embodiment as viewed from the ⁇ direction.
  • FIG. 7B is a schematic plan view of the porous structure layer in the sheet-like structure of the fifth embodiment when viewed from the ⁇ direction.
  • FIG. 8A is a schematic plan view of the porous structure layer in the sheet-like structure of the sixth embodiment when viewed from the ⁇ direction.
  • FIG. 8B is a schematic plan view of the porous structure layer in the sheet-like structure of the sixth embodiment when viewed from the ⁇ direction.
  • FIG. 8A is a schematic plan view of the porous structure layer in the sheet-like structure of the sixth embodiment when viewed from the ⁇ direction.
  • FIG. 8B is a schematic plan view of the porous structure layer in the sheet-
  • FIG. 9A is a schematic plan view of a porous structure layer in a sheet-like structure of the seventh embodiment as viewed from the ⁇ direction.
  • FIG. 9B is a schematic plan view of the porous structure layer in the sheet-like structure of the seventh embodiment when viewed from the ⁇ direction.
  • FIG. 10A is a schematic plan view of a porous structure layer in a sheet-like structure of the eighth embodiment as viewed from the ⁇ direction.
  • FIG. 10B is a schematic plan view of the porous structure layer in the sheet-like structure of the eighth embodiment when viewed from the ⁇ direction.
  • FIG. 11A is a schematic plan view of a porous structure layer in a sheet-like structure of the ninth embodiment as viewed from the ⁇ direction.
  • FIG. 11B is a schematic plan view of the porous structure layer in the sheet-like structure of the ninth embodiment when viewed from the ⁇ direction.
  • FIG. 12A is a schematic plan view of a porous structure layer in the sheet-like structure of the tenth embodiment as viewed from the ⁇ direction.
  • FIG. 12B is a schematic plan view of the porous structure layer in the sheet-like structure of the tenth embodiment when viewed from the ⁇ direction.
  • FIG. 13A is an explanatory diagram for explaining a specific flow channel shape in the embodiment.
  • FIG. 13B is an explanatory diagram for explaining a specific flow channel shape in the embodiment.
  • FIG. 13C is an explanatory diagram for explaining a missing flow channel shape in the example.
  • FIG. 13A is an explanatory diagram for explaining a specific flow channel shape in the embodiment.
  • FIG. 13B is an explanatory diagram for explaining a specific flow channel shape in the embodiment.
  • FIG. 13C is an explanatory diagram for explaining a missing flow channel shape
  • FIG. 13D is an explanatory diagram for explaining a missing flow channel shape in the example.
  • FIG. 14A is an explanatory diagram for explaining a single-sided or double-sided printing flow path in the embodiment.
  • FIG. 14B is a cross-sectional photograph of the single-sided printing flow path taken along line ff' in FIG. 14A.
  • FIG. 14C is a cross-sectional photograph of the double-sided printing flow path taken along line ff' in FIG. 14A.
  • FIG. 15 is a schematic cross-sectional view for explaining a porous structure layer in an example.
  • FIG. 16 is a schematic cross-sectional view for explaining a sheet-like structure in an embodiment.
  • FIG. 17 is a schematic cross-sectional view for explaining a sheet-like structure in an embodiment.
  • FIG. 18A is a graph showing the measurement results of the quantitative analysis in the example.
  • FIG. 18B is a graph showing the measurement results of the quantitative analysis in the example.
  • the sheet-like structure of the present invention has a porous structure layer in which at least a part of a flow path of a porous structure through which a fluid can flow is exposed on a surface, and a support layer,
  • the flow paths have a separation portion capable of separating adjacent flow paths to block the flow of the fluid in the flow paths.
  • Fig. 1A is a schematic perspective view of a sheet-like structure according to a first embodiment
  • Fig. 1B is a schematic cross-sectional view of the sheet-like structure of Fig. 1A taken along line aa'.
  • the sheet-like structure 11 has a porous structure layer 101, a support layer 301, and a separation section X. Although details will be described later, the sheet-like structure 11 has such a configuration, and thus can block the flow of fluid in the flow path of the porous structure layer 101, and can ensure, for example, a sufficient reaction time between a sample and a reaction reagent.
  • the porous structure layer 101 in the sheet-like structure 11 is provided with flow paths A, B, and C, each made of a porous structure through which a fluid can flow by capillary action or the like, and a non-flow path Y in an area other than the flow paths A to C.
  • the flow path C is connected to both the flow paths A and B, and the fluid can flow in the order of flow path A, flow path C, and flow path B, or in the order of flow path B, flow path C, and flow path A.
  • FIG. 1B when a fluid is received in the flow path A, the fluid flows in the order of flow path A, flow path C, and flow path B.
  • the flow path of the porous structure may be formed so that at least a part of it is exposed on the surface of the porous structure layer, and may be formed so that it is exposed on the entire surface of the porous structure layer.
  • the porous structure layer may have the porous structure (flow path) formed only on a part of the porous structure layer, or may be formed on the entire surface.
  • it is preferable that at least a part of the flow path exposed on the surface is a fluid receiving part.
  • flow path A into which a fluid is introduced can be the fluid receiving part.
  • flow path B can be the detection part.
  • the "fluid” is not particularly limited and can be appropriately selected depending on the purpose as long as it can flow through the flow path of the porous structure by capillary action, etc.
  • examples of the fluid include a solution containing a specimen or a reaction reagent that reacts with the specimen.
  • the viscosity of the fluid is not particularly limited as long as the fluid can flow through the flow paths of the porous structure, and can be appropriately adjusted depending on the purpose.
  • porous structure refers to a structure having a plurality of interconnected pores, and is generally also referred to as a co-continuous structure or a monolith structure.
  • the porous structure has continuously interconnected pores that extend three-dimensionally, allowing fluid to permeate (i.e., capillary action).
  • the cross-sectional shape of the pores in the porous structure can be appropriately set in consideration of the physical properties such as the viscosity of the fluid, and examples thereof include a substantially circular shape, a substantially elliptical shape, and a substantially polygonal shape.
  • the size of the pores in the porous structure is not particularly limited and can be appropriately selected according to the purpose.
  • the cross-sectional shape and size of the pores can be obtained, for example, from a cross-sectional photograph taken with a scanning electron microscope (SEM) or the like.
  • the porosity of the porous structure can be appropriately set in consideration of the physical properties of the liquid, such as the viscosity, etc.
  • the method for measuring the porosity is not particularly limited, but for example, a method can be mentioned in which the porous structure is filled with unsaturated fatty acid (commercially available butter), and then osmium staining is performed, and then the internal cross-sectional structure is cut out with an FIB, and the porosity is measured using a scanning electron microscope (SEM) or the like.
  • the distribution of pores in the porous structure can be appropriately set in consideration of the physical properties of the fluid, such as the viscosity, so long as the fluid can flow through it, but it is preferable that the pores are distributed uniformly within the flow path region.
  • the shape of the channels A to C in a plan view is not particularly limited as long as it allows fluid to flow therethrough and can be appropriately selected depending on the purpose. Examples of the shape include a circle, an ellipse, a square, and a rectangle.
  • the diameters of the channels A and B are not particularly limited and can be appropriately selected depending on the purpose, and can be, for example, ⁇ 3 mm or more and ⁇ 10 mm or less.
  • the width of the channel C is not particularly limited and can be appropriately selected depending on the purpose, and can be, for example, 1 mm or more and 5 mm or less.
  • the material M of flow paths A to C there are no particular limitations on the material M of flow paths A to C, so long as it has a porous structure that allows fluid to flow through it, and it can be appropriately selected depending on the purpose.
  • Examples include paper such as filter paper, nonwoven fabric, nitrocellulose, polypropylene, etc. Among these, filter paper is more preferable from the viewpoint of simplicity and low cost.
  • the non-flow passage Y is an area other than the flow passages A to C in the porous structure layer, that is, an area where no fluid flow occurs.
  • the material M' of the non-channel Y is not particularly limited and can be appropriately selected according to the purpose as long as it does not allow the flow of fluid, and can be obtained, for example, by impregnating the material M with a hydrophobic material.
  • the hydrophobic material is preferably one having a melting point of 90° C. or less, for example, wax or a composition containing the same.
  • the hydrophobic material can be appropriately blended with a viscosity adjusting component such as a resin, a dispersing agent, a filler, etc.
  • the hydrophobic material is preferably heated and melted.
  • the heating temperature can be appropriately set in consideration of the melting points of the hydrophobic material and the viscosity adjusting component.
  • the viscosity of the hydrophobic material when melted can be appropriately set so that the porous structure layer can be impregnated as desired, taking into consideration the average thickness and basis weight (density) of the porous structure layer.
  • the impregnation rate of the hydrophobic material with respect to the material M is within a range of 14% to 32%.
  • the porous structure layer so that the impregnation rate is 14% or more, the flow path wall surface (the interface between material M and material M') becomes sufficiently uniform, and for example, the flow of fluid from the flow path to the flow path can be made smoother.
  • the porous structure layer so that the impregnation rate is 32% or less, problems such as blockages that occur when impregnating material M with a hydrophobic material can be sufficiently avoided, and a porous structure layer having a desired flow path structure can be more reliably obtained.
  • the impregnation rate refers to the impregnation rate of the material M' in the region of the porous structure layer that is made of the material M' over the entire thickness direction.
  • the impregnation rate can be considered to be 100% for the material M' obtained by immersing the material M in a hydrophobic material that has been heated to a sufficiently low viscosity (e.g., heated to 120°C) and leaving it at the temperature for a sufficient time (e.g., 3 minutes).
  • the impregnation rate can be adjusted, for example, by adjusting the amount of the hydrophobic material to be impregnated (e.g., the thickness of the hydrophobic film).
  • the method for measuring the impregnation rate of the hydrophobic material into the material M is not particularly limited and may be appropriately selected depending on the purpose. For example, the following method may be mentioned.
  • Method of measuring impregnation rate The filter paper is cut to an appropriate size and dried at 120° C. for 3 minutes, and then the dry mass M0 (g) is measured. The filter paper is then immersed in a hydrophobic material and left at 120° C. for 3 minutes. The immersed filter paper is sandwiched between the same type of filter paper and a slide glass, and left at 120° C. for 1 minute under a load of 100 gf to remove excess hydrophobic material.
  • the viscosity of the hydrophobic material is not particularly limited and can be appropriately selected depending on the purpose, but for example, from the viewpoint of sufficiently avoiding problems such as clogging when impregnating the material M, the viscosity at 140° C. and a shear rate of 3000 s ⁇ 1 is preferably 100 mPa ⁇ s or less, more preferably 50 mPa ⁇ s or less, and even more preferably 30 mPa ⁇ s or less.
  • the measurement of the viscosity is not particularly limited, but can be measured, for example, using a rheometer (for example, product name: AR-G2 rheometer, manufactured by TA Instruments).
  • the material M' is preferably colored to allow easy visual confirmation of the flow of liquid, but may be white or transparent, or may be uncolored.
  • the coloring of the material M' can be achieved, for example, by impregnating the material M with a colorant in addition to the hydrophobic material.
  • colorants include pigments such as carbon black (black pigment), and are preferably hydrophobic.
  • the shape of the porous structure layer 101 in plan view is not particularly limited and can be appropriately selected depending on the purpose, and examples include a rectangle, a roughly circular shape, a roughly oval shape, a roughly rectangular shape, etc.
  • the porous structure layer 101 in the sheet-like structure 11 is provided with a separation section capable of separating adjacent flow paths in the flow paths in the porous structure layer 101 to block the flow of fluid in the flow paths.
  • the separation section separates the fluid receiving section from the flow path adjacent to the fluid receiving section to block the flow of the fluid received in the fluid receiving section to the flow path adjacent to the fluid receiving section. More specifically, for example, when the flow path A in Figures 1A and 1B is the fluid receiving section, it is preferable that the separation section separates the flow path A from the flow path C adjacent to the flow path A to block the flow of the fluid received in the flow path A to the flow path C.
  • separating adjacent flow paths to block the flow of fluid in the flow paths means separating the porous structure that forms the flow paths based on the separation section, thereby preventing the flow of fluid.
  • the separation section there are no particular restrictions on the location of the separation section as long as it can separate adjacent flow paths, but it is preferable that it is between the fluid receiving section and the detection section, and in an area excluding the fluid receiving section and the detection section.
  • the number of the separation sections is not particularly limited and can be appropriately set depending on the purpose. By increasing the number of the separation sections, multiple reactions (multi-stage reactions) can be carried out in one sheet-like structure.
  • the separation section is not particularly limited as long as it can separate adjacent flow paths, and can be appropriately selected depending on the purpose, but is preferably a cutting section.
  • the cutting section is a region that cuts the flow path in a direction intersecting the flow direction of the fluid in the flow path, as shown in Figures 1A and 1B.
  • the "direction intersecting the flow direction of the fluid” is not particularly limited, and may be, for example, a direction perpendicular to the flow direction of the fluid, as shown in Figure 1A, or a direction approximately perpendicular to the flow direction of the fluid.
  • the separation portion is not a cut portion
  • the porous structure can be pulled in the vertical or horizontal direction (horizontal direction in FIG.
  • the support described later is preferably made of a material (e.g., an elastic member) that can be pulled in the vertical or horizontal direction.
  • the separation portion is a cut portion
  • the cut portion is present only in the porous structure layer of the sheet-like structure, and not in the support layer described below.
  • the cut portion is provided so that when the sheet-like structure is separated based on the cut portion, the porous structure layer separates, but the support layer does not separate.
  • Fig. 2A is an explanatory diagram for explaining an example of the function of the separation unit. Specifically, it is a diagram showing a state in which the sheet-like structure 11 shown in Fig. 1A is folded at about 45° with the separation unit X as a reference.
  • Fig. 2B is an explanatory diagram for explaining another example of the function of the separation unit. Specifically, it is a diagram showing a state in which the sheet-like structure 11 shown in Fig. 1A is folded at about 180° with the separation unit X as a reference.
  • the support layer 301 remains connected without being separated.
  • the porous structure in the porous structure layer 101 is separated, i.e., adjacent flow paths are separated, and the flow of fluid in the flow paths is blocked. More specifically, for example, when flow path A is used as a fluid receiving section, the separation section separates flow path A from flow path C adjacent to flow path A, and the fluid received in flow path A is blocked from flowing to flow path C.
  • the sheet-like structure 11 has such a configuration, so that the fluid does not flow through the flow paths, and the fluid can be sufficiently retained in the fluid receiving portion.
  • the support layer 301 is not separated by the separation portion and functions as a hinge, so that after the fluid is retained for a predetermined time, the separated flow paths can be brought into contact again to continue the flow of the fluid, as shown in FIG. 1B.
  • a sufficient reaction time between the sample and the reagent can be ensured by introducing a sample and a reagent (e.g., an antigen and an antibody) that reacts with the sample into the fluid receiving portion of the sheet-like structure in the state of Fig. 2A or Fig. 2B. After the reaction is completed (or after a predetermined time has elapsed), the separated flow paths can be brought into contact again as shown in Fig. 1B to continue the flow of the sample and the reagent.
  • a reagent e.g., an antigen and an antibody
  • the sheet-like structure 11 can rectify the fluid received in the fluid receiving section. Specifically, by separating the flow path once using the separation section, it is possible to prevent the fluid from being unevenly distributed in the flow path and the fluid receiving section due to the momentum when the fluid is received.
  • the angle at which the sheet-like structure is folded with respect to the separation portion X is not particularly limited, and can be set appropriately according to the purpose, so long as the flow path is separated and the flow of fluid is blocked.
  • the sheet-like structure 11 has a support layer 301 .
  • the support layer 301 functions as a hinge for the sheet-like structure 11, and can bring the separated flow paths into contact again to continue the flow of fluid.
  • the support layer also has a function of reinforcing the physical strength of the sheet-like structure itself.
  • Figure 3A is an explanatory diagram for explaining one example of the distribution of the support layer
  • Figure 3B is an explanatory diagram for explaining another example of the distribution of the support layer
  • Figure 3C is an explanatory diagram for explaining yet another example of the distribution of the support layer.
  • the support layer in the sheet-like structure can be disposed in an area where the fluid receiving portion in the porous structure layer is not located.
  • it may be disposed only on the side where the fluid is not introduced into the fluid receiving portion, or as shown in Figure 3A, it may be disposed on both surfaces of the porous structure layer.
  • the support layer may be disposed so as to cover the exposed flow path or a part of the flow path. Note that, when the support layer is disposed on both surfaces of the porous structure layer, particularly on the side where the fluid is introduced into the fluid receiving portion, it is preferable to dispose it so as not to overlap with the separation portion.
  • the sheet-like structure having such a configuration can prevent contamination of the fluid flowing through the flow path.
  • the fluid is a specimen and a reagent (e.g., an antigen and an antibody, etc.), this is preferable because it can prevent reaction inhibition caused by contamination.
  • a reagent e.g., an antigen and an antibody, etc.
  • the support layer is preferably water-impermeable.
  • the material of the water-impermeable support layer is not particularly limited and can be appropriately selected depending on the purpose, and examples thereof include polypropylene.
  • the size, structure and shape of the support layer are not particularly limited as long as they can cover the flow path in the porous structure layer, and can be appropriately set depending on the purpose.
  • the support layer may be a commercially available product.
  • the product name of the commercially available product is 660-PF (manufactured by Nichiban Co., Ltd.).
  • the average thickness of the sheet-like structure 11 of the first embodiment is not particularly limited and can be appropriately selected depending on the purpose, and can be, for example, 100 ⁇ m to 300 ⁇ m.
  • the average thickness can be measured using a thickness meter such as id-c112bs (manufactured by Mitutoyo) under the trade name.
  • the size of the sheet-like structure 11 of the first embodiment is not particularly limited and can be appropriately selected depending on the purpose.
  • the porous structure layer may have a shape of the flow path exposed on one surface different from a shape of the flow path exposed on the other surface of the porous structure layer, in other words, the porous structure layer may have two or more layers having different flow path shapes.
  • Figure 4A is a schematic cross-sectional view of the sheet-like structure of the second embodiment
  • Figure 4B is a schematic plan view of the porous structure layer of Figure 4A when viewed from the ⁇ direction
  • Figure 4C is a schematic plan view of the porous structure layer of Figure 4A (i.e., the first porous structure layer 102 and the second porous structure layer 202 excluding the support layer 301 from the sheet-like structure 12 of the second embodiment) when viewed from the ⁇ direction
  • Figure 4A is also a schematic cross-sectional view when cut along the line bb' shown in Figures 4B and 4C.
  • the separation part X is omitted from illustration.
  • the first porous structure layer 102 in the sheet-like structure 12 of the second embodiment is provided with a flow path A, a flow path B, and a non-flow path Y in an area other than the flow paths A and B.
  • the flow paths A and B are separated from each other in the first porous structure layer 102.
  • the second porous structure layer 202 in the sheet-like structure 12 of the second embodiment is provided with a channel C, a channel D, a channel E, and a non-channel Y in an area other than the channels C, D, and E.
  • the channel E is connected to both the channels C and D, and fluid can flow in the order of channel C, channel E, and channel D, or in the order of channel D, channel E, and channel C.
  • a support layer 301 is provided on the surface on the side of the second porous structure layer 202 .
  • the first porous structure layer 102 and the second porous structure layer 202 are adjacent to each other with nothing interposed therebetween.
  • the flow path A of the first porous structure layer 102 and the flow path C of the second porous structure layer 202 are adjacent to each other, and the flow path B of the first porous structure layer 102 and the flow path D of the second porous structure layer 202 are adjacent to each other. That is, in the sheet-like structure 12 of the second embodiment, the flow paths are adjacent and connected in the order of flow path A, flow path C, flow path E, flow path D, and flow path B, or in the order of flow path B, flow path D, flow path E, flow path C, and flow path A. In the sheet-like structure 12 of the second embodiment, a separation portion X is formed so as to block the flow path C and the flow path E.
  • the tip region when the hydrophobic material is impregnated from the first porous structure layer 102 is drawn by a dotted line as a virtual line.
  • the tip region when the hydrophobic material is impregnated from the second porous structure layer 202 is drawn by a dotted line as a virtual line.
  • the virtual lines are similarly depicted in the other drawings.
  • the flow paths A, B, C, D, E, and Y are formed of the material M or M' described in the above ⁇ First aspect>.
  • the channels are adjacent and connected in the order of flow path A, flow path C, flow path E, flow path D, and flow path B, or in the order of flow path B, flow path D, flow path E, flow path C, and flow path A.
  • flow path A can be the fluid receiving section
  • flow path B can be the detection section.
  • the ratio (t2/t1) of the average thickness of the second porous structure layer (t2) to the average thickness (t1) of the first porous structure layer is preferably 0.56 or more and 2.2 or less.
  • the average thickness ratio (t2/t1) is more preferably greater than 1.0, that is, the average thickness (t2) of the second porous structure layer is more preferably greater than the average thickness (t1) of the first porous structure layer, more preferably 1.3 or more, and particularly preferably 1.8 or more.
  • the average thickness ratio (t2/t1) is not particularly limited and can be 3.0 or less.
  • FIG. 5A is a schematic cross-sectional view of the sheet-like structure of the third embodiment
  • Figure 5B is a schematic plan view of the porous structure layer of Figure 5A when viewed from the ⁇ direction
  • Figure 5C is a schematic plan view of the porous structure layer of Figure 5A when viewed from the ⁇ direction.
  • the sheet-like structure 13 shown in Figures 5A to 5C is the same as the sheet-like structure 12 of the second embodiment except that the flow path structure of the sheet-like structure is different from the flow path structure of the sheet-like structure of the second embodiment.
  • Figure 5A is also a schematic cross-sectional view when cut along the c-c' line shown in Figures 5B and 5C. Furthermore, the separation section X is omitted from Figures 5B and 5C.
  • a first porous structure layer 103 is provided with a flow path A, a flow path B, a flow path F connected to the flow path A, and a non-flow path Y as a portion other than the flow path F.
  • the flow path A and the flow path B are separated from each other in the first porous structure layer 103 in the sheet-like structure 13 of the third embodiment.
  • the sheet-like structure 13 of the third embodiment has a second porous structure layer 203 provided with a flow path D, a flow path E, and a non-flow path Y as a portion other than flow path D and flow path E, and flow path E is connected to flow path D.
  • a support layer 301 is provided on the surface on the side of the second porous structure layer 203 .
  • the flow path B of the first porous structure layer 103 and the flow path D of the second porous structure layer 203 are adjacent to each other, and the flow path F of the first porous structure layer 103 and the flow path E of the second porous structure layer 203 are connected to each other. That is, in the sheet-like structure 13 of the third embodiment, the flow paths A, F, E, D, and B are adjacent to each other and connected in this order, or the flow path B, D, E, F, and A are adjacent to each other and connected to each other in this order.
  • a separation portion X is formed so as to block the flow path F and the flow path E.
  • the flow paths A, B, D, E, F, and non-flow paths Y are formed of the material M or M' described in the above ⁇ First aspect> section.
  • the sheet-like structure 13 of the third embodiment is configured such that, for example, when a fluid is dropped into flow path A, the liquid passes through flow paths A, F, E, and D in this order by capillary action or the like, and finally flows into flow path B.
  • flow path A can be used as a fluid receiving section
  • flow path B can be used as a detection section.
  • FIG. 6A is a schematic cross-sectional view of the sheet-like structure of the fourth embodiment
  • Figure 6B is a schematic plan view of the porous structure layer of Figure 6A when viewed from the ⁇ direction
  • Figure 6C is a schematic plan view of the porous structure layer of Figure 6A when viewed from the ⁇ direction.
  • the sheet-like structure 14 shown in Figures 6A to 6C is the same as the sheet-like structure 12 of the second embodiment, except that the flow path structure of the sheet-like structure is different from the flow path structure of the sheet-like structure of the second embodiment.
  • Figure 6A is a schematic cross-sectional view taken along the line d-d' shown in Figures 6B and 6C.
  • a flow path B and a non-flow path Y as a portion other than the flow path B are provided in the first porous structure layer 104, and a flow path A is not provided.
  • 6C in the sheet-like structure 14 of the fourth embodiment, a channel A, a channel D, a channel E, and a non-channel Y as a portion other than the channels A, E, and D are provided in the second porous structure layer 204.
  • the channel E is connected to both the channel D and the channel A.
  • a support layer 301 is provided on the surface on the side of the second porous structure layer 204 .
  • the flow path D of the first porous structure layer 104 is adjacent to the flow path B of the second porous structure layer 204. That is, in the sheet-like structure 14 of the fourth embodiment, the flow paths A, E, D, and B are adjacent to each other and connected in this order, or the flow path B, D, E, and A are adjacent to each other and connected in this order. In the sheet-like structure 14 of the fourth embodiment, a separation portion X is formed so as to block the flow path A and the flow path E.
  • the flow paths A, B, D, E, and Y are formed of the material M or M' described in the above ⁇ First aspect> section.
  • the sheet-like structure 14 of the fourth embodiment is configured such that, for example, when a fluid is dropped into flow path A, the liquid passes through flow paths A, E, and D in this order by capillary action or the like, and finally flows into flow path B.
  • flow path A can be used as a fluid receiving section
  • flow path B can be used as a detection section.
  • FIG. 7A is a schematic plan view of the porous structure layer in the sheet-like structure of the fifth embodiment when viewed from the ⁇ direction
  • Figure 7B is a schematic plan view of the porous structure layer in the sheet-like structure of the fifth embodiment when viewed from the ⁇ direction.
  • the sheet-like structure of the fifth embodiment is similar to that of Figures 4B and 4C, except that the flow path D provided in the second porous structure layer 205 has a ring-shaped structure, and a non-flow path Y1 is formed inside the ring-shaped structure.
  • the flow channel D which is an annular structure, may have any contour shape, such as a circle, an ellipse, a rectangle, etc., but preferably has a contour shape that substantially matches the contour shape of the flow channel B in a plan view of the sheet-like structure.
  • the non-flow channel Y formed inside the flow channel D preferably has a shape that is a scaled-down version of the contour shape of the flow channel D in a plan view of the sheet-like structure.
  • FIG. 8A is a schematic plan view of the porous structure layer in the sixth embodiment of the sheet-like structure when viewed from the ⁇ direction
  • Figure 8B is a schematic plan view of the porous structure layer in the sixth embodiment of the sheet-like structure when viewed from the ⁇ direction.
  • the sheet-like structure of the sixth embodiment is similar to that of the second porous structure layer 206 having a structure in which the second porous structure layer 206 has a plurality of flow paths E (two flow paths E1 and E2 in FIG. 8B).
  • a plurality of flow paths F may be provided in the same number as the number of flow paths E, and the plurality of flow paths F in the first porous structure layer and the plurality of flow paths E in the second porous structure layer may be connected to each other.
  • Figure 9A is a schematic plan view of the porous structure layer in the seventh embodiment of the sheet-like structure when viewed from the ⁇ direction
  • Figure 9B is a schematic plan view of the porous structure layer in the seventh embodiment of the sheet-like structure when viewed from the ⁇ direction.
  • the sheet-like structure of the seventh embodiment is a combination of the flow channel shapes shown in Figs. 7A, 7B, 8A, and 8B.
  • FIG. 10A is a schematic plan view of the porous structure layer in the sheet-like structure of the eighth embodiment when viewed from the ⁇ direction
  • Figure 10B is a schematic plan view of the porous structure layer in the sheet-like structure of the eighth embodiment when viewed from the ⁇ direction.
  • the sheet-like structure of the eighth embodiment is generally similar to that of Fig. 9B, except that the second porous structure layer 208 has a structure having three flow paths E (E1, E2, and E3).
  • the three flow paths E are connected to a flow path D so as to face each other.
  • FIG. 11A is a schematic plan view of the porous structure layer in the sheet-like structure of the ninth embodiment when viewed from the ⁇ direction
  • Figure 11B is a schematic plan view of the porous structure layer in the sheet-like structure of the ninth embodiment when viewed from the ⁇ direction.
  • the sheet-like structure of the ninth embodiment is generally similar to that of Figure 10B, except that it has a structure in which flow path E3 branches into two (E31 and E32) and is connected to flow path D.
  • FIG. 12A is a schematic plan view of the porous structure layer in the sheet-like structure of the tenth embodiment when viewed from the ⁇ direction
  • Figure 12B is a schematic plan view of the porous structure layer in the sheet-like structure of the tenth embodiment when viewed from the ⁇ direction.
  • the sheet-like structure of the tenth embodiment is generally similar to that of Fig. 11B, except that it has a structure having two channels E (E3 and E4) in addition to channels E1 and E2.
  • the four channels E are connected to a channel D so as to face each other.
  • the number of channels E (and channels F) is preferably 4 or less, more preferably 3 or less, and even more preferably 2.
  • the number of connection points of channel E to channel D is preferably 4 or less, more preferably 3 or less, and even more preferably 2.
  • At least two of the multiple flow paths E are preferably connected to the flow path D so as to face each other.
  • at least two of the multiple flow paths E are preferably formed in substantially the same shape.
  • the above-mentioned sheet-like structure can be manufactured, for example, by forming a predetermined portion (such as flow path B) in a sheet-like material to produce a first porous structure layer, forming a predetermined portion (such as flow path D) in another sheet-like material to produce a second porous structure layer, and laminating these.
  • the above-mentioned sheet-like structure can also be manufactured by forming a predetermined portion in a part of a sheet-like material to produce a first porous structure layer, forming a predetermined portion in another part of the single sheet-like material to produce a second porous structure layer, and folding the single sheet-like material while adjusting the positions of the first porous structure layer and the second porous structure layer.
  • the sheet-like structure in the present invention is preferably produced by forming a first porous structure layer on one side of a sheet-like material and a second porous structure layer on the other side.
  • a sheet-like structure in which a first porous structure layer and a second porous structure layer are formed on both sides of a sheet-like material has various advantages, such as (1) the labor and cost of stacking (or folding) can be avoided, (2) liquid circulation by capillary action is ensured between the first porous structure layer and the second porous structure layer, and (3) disposal is easy because no tool or the like is required to hold the stacked (or folded) sheet-like material.
  • the sheet-like structure As a specific method for producing the sheet-like structure, for example, it can be produced by the following method.
  • a hydrophobic material, a colorant, and a resin are blended, and melt-mixed at, for example, 100°C to 140°C to prepare a wax ink.
  • the wax ink is applied to a substrate such as a polyethylene terephthalate film to prepare an ink ribbon.
  • a specific flow path shape is printed on high-quality paper using a thermal transfer printer (e.g., product name: Respri R412v-ex, manufactured by Sato Holdings Corporation), to form a missing flow path pattern in the printed portion of the ink ribbon.
  • a thermal transfer printer e.g., product name: Respri R412v-ex, manufactured by Sato Holdings Corporation
  • the ink ribbon on which the missing flow path pattern is formed is fixed to the front and back of a filter paper, and then passed through a thermal laminator (e.g., product name: GL535ML, manufactured by GBG) set to a predetermined temperature and line speed, whereby the wax ink is transferred and penetrated into the filter paper to form a three-dimensional flow path, thereby producing a sheet-like structure.
  • a thermal laminator e.g., product name: GL535ML, manufactured by GBG
  • the filter paper is not particularly limited and can be appropriately selected depending on the purpose.
  • filter paper having an average thickness of 310 ⁇ m, basis weight of 94 g/m 3 , and CFR (Capillary flow rate) of 13.9 sec/4 cm can be used.
  • the "predetermined temperature and line speed" are not particularly limited as long as the conditions are such that the wax ink can penetrate and be transferred to the filter paper, but for transfer, the temperature can be 85°C and the line speed can be 10 mm/sec, and for penetration, the temperature can be 85°C and the line speed can be 5 mm/sec.
  • a method of using the sheet-like structure of the present invention is characterized in that a fluid is received into a first flow path located on one side of the separation section, the first flow path and the second flow path are separated in the separation section to block the flow of the fluid so that the fluid received into the first flow path does not flow into a second flow path located on the other side of the separation section, and after a certain period of time, the first flow path and the second flow path are brought into contact with each other in the separation section to allow the fluid to flow between the first flow path and the second flow path.
  • the first flow path is the fluid receiving portion, and the detection portion is disposed in a part of the second flow path.
  • the "first flow path” is preferably, in other words, a flow path on the side where a fluid receiving portion that receives a fluid is present when the flow paths are separated based on the separation portion. That is, in Fig. 1B, it is preferably a flow path including flow path A that is present on the left side of separation portion X in the figure.
  • the "second flow path” is preferably a flow path on the side other than the first flow path, i.e., a flow path on the side where the detection unit is present, when the flow paths are separated based on the separation unit. That is, in Fig.
  • separating the first flow path and the second flow path in the separation section to block the flow of the fluid means, for example, separating each flow path (porous structure) based on the separation section, as shown in Figures 2A and 2B.
  • the "certain period of time” can be appropriately set depending on the viscosity of the fluid being passed and the reaction time of components (for example, antigens and antibodies) contained in the fluid.
  • contacting the first flow path with the second flow path in the separation section to allow the fluid to circulate between the first flow path and the second flow path means, for example, returning a sheet-like structure in the state of FIG. 2A or FIG. 2B to the state of FIG. 1B.
  • a blocking agent may be applied to the fluid receiving section and the detection section in advance in order to prevent fluids (such as specimens such as antigens and reagents such as antibodies) from flowing through them and being adsorbed.
  • fluids such as specimens such as antigens and reagents such as antibodies
  • blocking agents include an aqueous albumin solution, but it is preferable to select an appropriate agent depending on the type of fluid and its physical properties such as viscosity.
  • the sheet-like structure of the present invention can be suitably used as a test device.
  • test devices include pregnancy test kits and test devices that use a measurement method called immunochromatography, which combines the principles of sandwich ELISA and chromatography.
  • Paraffin wax as hydrophobic material product name: ParaffinWax-135, manufactured by Nippon Seiro Co., Ltd.
  • synthetic wax product name: Diacarna (registered trademark) 30, manufactured by Mitsubishi Chemical Corporation
  • carbon black product name: MA-100, manufactured by Mitsubishi Chemical Corporation
  • resin product name: Ultrathene (registered trademark) 722, manufactured by Tosoh Corporation) 11.25 parts by mass.
  • the viscosity of the obtained wax ink was 23 mPa ⁇ s under the conditions of 140°C and a shear rate of 3000 s-1 .
  • the viscosity was measured using a rheometer AR-G2 (manufactured by TA Instruments).
  • the obtained wax ink was applied onto a polyethylene terephthalate film (product name: Lumirror (registered trademark) #6C F531, manufactured by Toray Industries, Inc.) having an average thickness of 6 ⁇ m to an average thickness of 5 ⁇ m to 12 ⁇ m to produce an ink ribbon.
  • a thermal transfer printer product name: Respri R412v-ex, manufactured by Sato Holdings Corporation was used to print the flow path shape shown in Figures 13A and 13B on high-quality paper, thereby forming a flow path pattern that was missing in the printed area of the ink ribbon (see Figures 13C and 13D).
  • FIG. 14A a cross-sectional photograph of the flow path was taken using a microscope (manufactured by Keyence Corporation).
  • the result is shown in FIG. 14B.
  • the flow path pattern shown in Fig. 14A was printed on both sides of a filter paper (product name: Whatman #41), and penetration was performed under the same conditions to form a double-sided printed flow path in the filter paper.
  • the double-sided printed flow path was immersed in an aqueous solution of fluorescent ink (fluorescent felt-tip pen, manufactured by Askul Corporation), and then cut at a position corresponding to line f-f' in Fig. 14A, and a cross-sectional photograph of the flow path was taken using a microscope (manufactured by Keyence).
  • FIG. 14C Fluorescent ink was confirmed only in the dotted-line area in Figures 14B to 14C, and no leakage of the fluorescent ink was observed in other areas. From this, it was confirmed that the flow path was properly formed.
  • Figure 14B shows single-sided printing, i.e., the wax ink was permeated from one side of the filter paper, so the flow path formed is tapered, widening from the side where the wax ink was permeated to the opposite side.
  • Figure 14C shows double-sided printing, i.e., the wax ink was permeated from both sides of the filter paper, so the flow path formed is symmetrical and diamond-shaped.
  • Paraoxon ethyl (or paraoxon) is a type of phosphorus-based pesticide. When paraoxon adheres to crops and the like, it is a neurotoxin that inhibits the function of acetylcholinesterase (AChE), which is involved in neurotransmission, and causes convulsions, miosis, and the like when it enters the body.
  • AChE acetylcholinesterase
  • the concentration of paraoxon ethyl in a sample is quantitatively analyzed using a sheet-like structure.
  • the obtained porous structure layer had the structure shown in Fig. 15.
  • Fig. 15 is a schematic cross-sectional view taken along the line e-e' shown in Figs. 13A to 13D.
  • the obtained porous structure layer was labeled with flow paths A to H as shown in Fig. 15.
  • a layer having flow path A as a fluid receiving portion and flow path B as a detection portion is shown as a first porous structure layer 111, and a layer other than the first porous structure layer 111 is shown as a second porous structure layer 211.
  • IDA is a substrate that reacts with AChE to produce a blue color.
  • IDA Sigma-Aldrich
  • methanol Flujifilm Wako Pure Chemical Industries, Ltd.
  • 3 ⁇ L of this solution was dropped into the detection section (flow path B) and dried at 30° C. for 15 minutes.
  • support layer-- Adhesive tape product name: 660PF, manufactured by Nichiban Co., Ltd.
  • the support layer on the side of the first porous structure layer 111 is designated as 302
  • the support layer on the side of the second porous structure layer 211 is designated as 301.
  • a separation portion X was formed by cutting between the fluid receiving portion (flow path A) and the flow path C adjacent to the fluid receiving portion with a cutter, thereby obtaining a sheet-like structure 15.
  • the obtained sheet-like structure 15 had the structure shown in FIG.
  • the obtained sheet-like structure 15 was folded 180° with the separation portion X as a reference as shown in FIG. 17 and fixed with a clip.
  • Tris-HCl (pH 8.0) (manufactured by Nippon Gene Co., Ltd.), 3 ⁇ L of which was dropped onto the fluid receiving part (flow path A) and dried at 30° C. for 15 minutes.
  • Tris-HCl (pH 8.0) was prepared with EtOH (manufactured by Fujifilm Wako Pure Chemical Industries, Ltd.) added to a concentration of 6 vol.%, and solutions containing paraoxon ethyl (manufactured by Sigma-Aldrich) at concentrations of 0 ⁇ g/L, 200 ⁇ g/L, 400 ⁇ g/L, and 800 ⁇ g/L were prepared.
  • the sample in which the sheet-like structure was folded at the separation section showed an increase in L * value and an increase in b * value.
  • the adjacent flow paths were completely blocked, and sufficient reaction time between paraoxon ethyl and AChE could be secured, thereby improving the accuracy of the quantitative analysis.
  • First sheet-like structure of the first embodiment First sheet-like structure of the second embodiment 13 First sheet-like structure of the third embodiment 14 First sheet-like structure of the fourth embodiment 15 First sheet-like structure of the fifth embodiment 16 First sheet-like structure of the sixth embodiment 17 First sheet-like structure of the seventh embodiment 18 First sheet-like structure of the eighth embodiment 19 First sheet-like structure of the ninth embodiment 101 Porous structure layer 102 First porous structure layer 103 First porous structure layer 104 First porous structure layer 105 First porous structure layer 106 First porous structure layer 107 First porous structure layer 108 First porous structure layer 109 First porous structure layer 110 First porous structure layer 111 First porous structure layer 202 Second porous structure layer 203 Second porous structure layer 204 Second porous structure layer 205 Second porous structure layer 206 Second porous structure layer 207 Second porous structure layer 208 Second porous structure layer 209 Second porous structure layer 210 Second porous structure layer 211 Second porous structure layer 301 Support layer 302 Support layer 303 Support layer 304 Support layer A Flow path B

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PCT/JP2023/039971 2022-11-28 2023-11-07 シート状構造物及びその使用方法 Ceased WO2024116740A1 (ja)

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CN202380079665.3A CN120225883A (zh) 2022-11-28 2023-11-07 片状结构物及其使用方法
KR1020257015036A KR20250087620A (ko) 2022-11-28 2023-11-07 시트 형상 구조물 및 그 사용 방법
EP23897394.5A EP4628902A1 (en) 2022-11-28 2023-11-07 Sheet-like structure and method for using same

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002219697A (ja) * 2000-09-22 2002-08-06 Kawamura Inst Of Chem Res バルブ機構を有するマイクロ流体デバイス及びその流量調節方法
JP2003139660A (ja) * 2001-11-02 2003-05-14 Kawamura Inst Of Chem Res マイクロ流体デバイス及びその製造方法
JP2005083510A (ja) * 2003-09-09 2005-03-31 Toshiba Corp バルブ装置、化学分析装置及び化学分析システム
JP2009541037A (ja) * 2006-06-28 2009-11-26 マイクロリティック アーペーエス 結晶化を促進するデバイス及び方法
JP2011145236A (ja) * 2010-01-18 2011-07-28 Seiko Epson Corp マイクロ流体チップおよびこれを用いた検体の測定方法
JP2016003922A (ja) * 2014-06-16 2016-01-12 株式会社エンプラス 流体取扱装置
JP2021175970A (ja) 2020-04-28 2021-11-04 デクセリアルズ株式会社 検査チップ、及びその製造方法
JP2022188860A (ja) 2021-06-10 2022-12-22 大成建設株式会社 移動体位置推定システム、移動体位置推定方法

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002219697A (ja) * 2000-09-22 2002-08-06 Kawamura Inst Of Chem Res バルブ機構を有するマイクロ流体デバイス及びその流量調節方法
JP2003139660A (ja) * 2001-11-02 2003-05-14 Kawamura Inst Of Chem Res マイクロ流体デバイス及びその製造方法
JP2005083510A (ja) * 2003-09-09 2005-03-31 Toshiba Corp バルブ装置、化学分析装置及び化学分析システム
JP2009541037A (ja) * 2006-06-28 2009-11-26 マイクロリティック アーペーエス 結晶化を促進するデバイス及び方法
JP2011145236A (ja) * 2010-01-18 2011-07-28 Seiko Epson Corp マイクロ流体チップおよびこれを用いた検体の測定方法
JP2016003922A (ja) * 2014-06-16 2016-01-12 株式会社エンプラス 流体取扱装置
JP2021175970A (ja) 2020-04-28 2021-11-04 デクセリアルズ株式会社 検査チップ、及びその製造方法
JP2022188860A (ja) 2021-06-10 2022-12-22 大成建設株式会社 移動体位置推定システム、移動体位置推定方法

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
QUOC TRUNG HUA ET AL., ANALYTICAL SCIENCES, vol. 35, April 2019 (2019-04-01), pages 393 - 399
See also references of EP4628902A1

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TW202441178A (zh) 2024-10-16

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