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WO2015189960A1 - Instrument de prélèvement d'échantillon de sang - Google Patents

Instrument de prélèvement d'échantillon de sang Download PDF

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Publication number
WO2015189960A1
WO2015189960A1 PCT/JP2014/065627 JP2014065627W WO2015189960A1 WO 2015189960 A1 WO2015189960 A1 WO 2015189960A1 JP 2014065627 W JP2014065627 W JP 2014065627W WO 2015189960 A1 WO2015189960 A1 WO 2015189960A1
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WO
WIPO (PCT)
Prior art keywords
blood
body fluid
bodily
collection
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/JP2014/065627
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English (en)
Japanese (ja)
Inventor
功 米久保
進 大澤
晋哉 杉本
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.)
Leisure Inc Japan
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Leisure Inc Japan
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Filing date
Publication date
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Priority to PCT/JP2014/065627 priority Critical patent/WO2015189960A1/fr
Publication of WO2015189960A1 publication Critical patent/WO2015189960A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N1/00—Sampling; Preparing specimens for investigation
    • G01N1/02—Devices for withdrawing samples
    • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers

Definitions

  • the present invention relates to a bodily fluid sample collection device and a bodily fluid dilution container for collecting a bodily fluid sample (blood, saliva, tears, sweat, etc.) to be tested in a clinical test such as a biochemical test.
  • the present invention relates to a blood sample collection device and a blood dilution container.
  • Patent Document 1 describes a body fluid sample separation device (blood separation device) in which a subject to be examined collects blood as a body fluid sample in order to simplify the body fluid sample collection operation.
  • the blood separation instrument includes a blood collection container, a cylinder that can be inserted into the blood collection container, a cap piston that can be attached to the cylinder, and a sealing lid that is provided at the lower end of the cap piston.
  • the test subject pierces the finger of his / her hand with a blood collection needle, collects a small amount of blood into a blood collection container containing a blood dilution buffer (dilution solution), and the collected blood is gradually dissolved in the dilution solution. Separated into blood cells and plasma or serum.
  • the test subject inserts and fixes the cylinder with the cap piston attached to the blood collection container, so that the plasma or serum in the diluted solution passes through the filtration membrane at the tip of the cylinder and moves to the cylinder side.
  • the blood cells cannot pass through the filtration membrane and remain in the blood collection container.
  • the test subject can easily separate blood sampled from blood cells and plasma or serum by using this instrument.
  • the test subject directly attaches a small amount of blood from the finger of his / her hand to the mandrel (fiber rod) of the cylindrical body that can be inserted into the blood collection container, thereby causing blood to flow through the capillary phenomenon. It is collected in a rod, and the fiber rod is dropped into a blood collection container containing a blood dilution buffer, and the blood absorbed by the fiber rod can be diffused and dissolved in the blood dilution buffer.
  • a small amount of blood necessary for blood collection with such a blood separation device is about 65 microliters ( ⁇ L), and in order to measure blood components and enzyme activity, the blood is diluted with an internal standard substance.
  • a buffer solution diluted solution
  • blood which is a body fluid sample, can be mailed to an examination center or a hospital.
  • the subject to be examined collects blood by himself, so that a sufficient amount of blood can be collected to maintain the reliability of the examination. There may not be.
  • a tube having a fiber rod is inserted into a blood collection container containing a blood dilution buffer, and the fiber rod is immersed in the blood dilution buffer.
  • blood components are not sufficiently eluted from the fiber rod.
  • the person to be inspected collects 1 to 2 drops of blood using a fiber rod as a guide when collecting blood from the finger of the hand, so that the prescribed amount required for the inspection (for example, about 65 microliters)
  • the subject of the test stops collecting when the fiber rod turns red with blood at his or her own discretion. Even if collected, the amount of plasma components eluted from the fiber rod may be insufficient, and the reliability of the test results for blood may be reduced.
  • a blood collection lid provided with means (blood collection unit) for collecting blood from fingers without using a fiber rod
  • a blood dilution container for diluting blood with a blood dilution buffer.
  • a blood sample sampling device is: A bodily fluid collection lid having a cylindrical bodily fluid collection portion and a lid portion; A body fluid dilution container that can be sealed by inserting the body fluid collection part and screwing the body fluid collection lid;
  • the bodily fluid collecting unit has a slope for flowing the collected bodily fluid and a recess for holding the bodily fluid flowing from the slope inside, and the volume (mm 2 ) of the container in which the bodily fluid sample is placed is in contact with the bodily fluid sample
  • the ratio (surface area / volume) of the surface area (mm 3 ) is 1.1 (mm 2 / mm 3 ) or more.
  • an angle of the slope with respect to a horizontal edge of the bodily fluid collecting portion is 70 degrees to 115 degrees, preferably 95 degrees to 115 degrees. .
  • a flat portion is provided between the slope and the recess.
  • the bottom surface of the recess is formed in an uneven shape.
  • an anticoagulant is applied to the inner wall and the bottom surface of the recess.
  • a screw structure having a plurality of threads is formed on the inner peripheral side wall of the lid portion of the body fluid sampling lid,
  • a screw structure having a plurality of screw threads is formed on the outer peripheral side wall of the body fluid dilution container in contact with the inner peripheral side wall of the lid when sealed.
  • the concave portion is arranged close to a part of the inner wall of the bodily fluid collecting portion.
  • a planar collection wall is provided on the partial inner wall where the concave portion is brought close to.
  • one or more capillaries made of linear grooves are provided on the surface of the collecting wall.
  • the bodily fluid dilution container holds a bodily fluid dilution buffer, and the bodily fluid dilution buffer contains an internal standard substance.
  • the body fluid is blood
  • the body fluid dilution container holds a blood dilution buffer therein
  • the blood dilution buffer is either an internal standard substance that does not penetrate into blood cells or an internal standard substance that penetrates into blood cells, Or it is characterized by including both.
  • the internal standard substance contained in the blood dilution buffer has a property of not penetrating into blood cells, and is a disaccharide containing maltose, glutamic acid, leucine , Valine, isoleucine, 4-hydroxyxenebenzene, hydroxybutyric acid, creatine, malic acid, and a Trinder reagent.
  • the internal standard substance contained in the blood dilution buffer has a property of penetrating into blood cells, and includes 2-phenylethylamine, ethanolamine, and hexylamine. And a substance selected from the group consisting of amyramine, histamine, putrescine, hypoxanthine, tryptophan, pregrenolone, and ⁇ -sitosterol.
  • the internal standard substance contained in the blood dilution buffer is a mixture of an internal standard having a property of penetrating into blood cells and two internal standards that do not penetrate into blood cells.
  • the bodily fluid sampling part is formed of a transparent or translucent material.
  • the bodily fluid sampling device can be reliably collected by scooping a small amount of blood from the fingers with the bodily fluid collection lid, and the operation of the device is very simple.
  • the body fluid collection part since the collected blood enters the concave part of the body fluid collection part of the body fluid collection lid and does not spill even if it is reversed by the surface tension of the blood, the body fluid collection part is inserted into the body fluid dilution container. It can be easily sealed by screwing. After sealing, high airtightness can be maintained, so that the blood sample can be transported safely. As a result, it is possible to reliably collect a small amount of finger blood and improve the reliability of the test result.
  • the body fluid sample collecting device of the present invention can be applied not only to blood but also to body fluids in general. As a result, it can contribute to public health management and early detection of diseases.
  • FIG. 6 shows one embodiment of a blood collection lid.
  • FIG. 3 is a cross-sectional view of the blood sampling lid cut in a vertical direction along the line AA in FIG. 2. It is sectional drawing which shows another embodiment which changed the angle of the slope of the blood collection lid
  • FIG. 6 is a cross-sectional view of the blood sampling lid cut in a vertical direction along the line BB in FIG. 5. It is a figure which shows another embodiment of the blood collection lid
  • FIG. 8 is a cross-sectional view of the blood sampling lid cut in a vertical direction along the line CC in FIG. It is a figure which shows the blood collection lid
  • a plurality of embodiments according to the present invention are intended to collect a blood sample as an example of a body fluid sample
  • other body fluid samples such as saliva, saliva, sweat, etc.
  • the body fluid sample to be collected is blood
  • FIG. 1 shows a configuration of a blood sample collecting device according to one embodiment of the present invention.
  • the blood sample collection device is composed of a blood collection lid 100 and a blood dilution container 200.
  • the blood collection lid 100 has a cylindrical blood collection unit 102 that can be accommodated in the blood dilution container 200, and a recess 104 and an upper edge of the recess 104 are adjacent to the inside of the cylinder of the blood collection unit 102. And a slope 108 adjacent to the outer periphery of the flat portion 106.
  • a blood dilution buffer 202 is placed in the blood dilution container 200 for examination.
  • the blood collection lid 100 and the blood dilution container 200 can be made of plastic, and the blood dilution container 200 can be made of a transparent material such as transparent plastic or glass.
  • the blood collection part 102 can be formed using a transparent or translucent material (plastic or glass) so that the blood collected in the recess 104 can be easily confirmed.
  • a lid 110 is formed at the end of the blood collection lid 100 opposite to the end having the blood collection section 102, and the blood collection section 102 is brought into the blood dilution container 200 from the opening 204 of the blood dilution container 200.
  • the screw structure 112 inside the lid 110 and the screw structure 206 of the blood dilution container 200 can be sealed by screwing.
  • the inner circumference of the lid 110 of the blood collection lid 100 is slightly larger than the outer circumference of the blood dilution container 200, and the screw structure 112 having a plurality of screw threads is formed in the gap between the lid 110 and the cylinder of the blood collection unit 102. , Formed on the inner peripheral side wall of the lid 110.
  • the screw structure 206 having a plurality of threads is formed on the outer peripheral side wall of the blood dilution container 200 in contact with the inner peripheral side wall of the lid part 110 when the blood dilution container 200 is sealed with the blood collection lid 100.
  • two protrusions can be provided as the threads in the screw structure 112, and similarly, two protrusions can be provided as the threads in the screw structure 206.
  • the inner periphery of the blood dilution container 200 is slightly larger than the outer periphery of the blood collection part 102 of the blood collection lid 100, and the cylindrical blood collection part 102 can be accommodated inside the cylindrical blood dilution container 200. is there.
  • the lid 110 of the blood collection lid 100 By turning the lid 110 of the blood collection lid 100 in a state where the blood collection portion 102 is housed in the blood dilution container 200, the screw structure 112 of the lid 110 and the screw structure 206 of the blood dilution container 200 are screwed in mesh.
  • the blood dilution container 200 is sealed with the blood collection lid 100.
  • the blood collection lid 100 and the blood dilution container 200 containing the blood dilution buffer 202 can be combined with each other by screwing, and fulfill the functions of a lid and a container that maintain a high degree of airtightness.
  • the collector can safely mail the blood sample collection device containing the blood sample to an examination center or a hospital.
  • the blood sample collection instrument containing the blood sample sent by mail is analyzed at an examination center or hospital.
  • a specific analysis method is a method for quantitatively analyzing a component of a body fluid sample containing blood cells of unknown concentration collected and analyzing the enzyme activity, which is a component that is not or hardly contained in a body fluid sample.
  • An internal standard that does not pass through the membrane is prepared, and this is added to a blood dilution buffer (hereinafter also simply referred to as “buffer”). Analyze the internal standard concentration in the buffer before adding blood, and measure the absorbance and the concentration of the internal standard in the diluted buffer after adding blood.
  • the plasma dilution rate is determined, and the biological components and enzyme activities in the raw plasma are determined.
  • the osmotic pressure of the buffer solution is adjusted so as to be approximately the blood osmotic pressure.
  • the blood dilution method in the present invention can be defined as follows.
  • the blood dilution method is a measurement method developed to obtain the maximum amount of biological information with the minimum blood volume. This method allows the blood dilution rate to be calculated backward by making the internal standard substance present in the diluted solution, and the measurement result can be brought close to the original blood measurement value by correcting the dilution rate. Since this measurement method is a quantitative measurement, it can be said that it is a measurement technique with a much higher accuracy than the qualitative measurement, but its precision and accuracy are not equal compared with the case of directly measuring blood material.
  • the accuracy and accuracy of the dilution method is sufficient to distinguish between healthy individuals and those with disease, and the minimum blood volume required for this method is extremely small (almost several drops of blood volume 65 ⁇ L). Therefore, it is the amount of blood that can be collected from a fingertip or the like without imposing a special burden even for general users at home or the like.
  • the blood dilution method can be said to be the only method that can provide the measurement values of a multi-item test with a small amount of blood.
  • hydrogen peroxide is generated by adding an oxidase using the internal standard substance or a substance derived from the internal standard substance as a substrate, and peroxidase
  • an enzymatic measurement method in which the color development of a quinone dye, NAD (P) H, or tetrazonium salt obtained by oxidative condensation of a Trinder reagent and 4-aminoantipyrine in the presence is measured and quantified as absorbance.
  • the internal standard substance to be put in the buffer solution is a component that does not exist in the living body or is present in a very small amount, and the blood cell membrane It must be non-permeable, stable in buffer solution, and not adsorbed on the container. It is also necessary not to interfere with other biological components.
  • Internal standard substances that permeate the blood cell membrane include chemical groups with a molecular weight of 500 or less, such as amino groups (-NH 2 ), alkyl groups (-CH 3 , -C 6 H 6 ), ester groups (-COOR), alkoxy groups ( -OR), halogen (-Cl, -Br, -I) and other hydrophobic substituents, 2-phenylethylamine, ethanolamine, hexylamine, amiramine, histamine, putrescine, hypoxanthine, tryptophan, pregrenolone , ⁇ -sitosterol and the like. Corresponding to these internal standards can be analyzed by enzymatic measurement using oxidase. Since these internal standard substances are distributed in blood cells and plasma, they can be used to determine the dilution factor of whole blood (plasma + blood cells).
  • the buffer solution for diluting the biological component must be miscible with the body fluid sample in an arbitrary amount, and the component to be measured in the body fluid sample must be stably stored.
  • the components of the buffer solution are not limited, but HEPES ⁇ 2- [4- (2-hydroxyethyl) -1-piperazinyl] ethanesulfonic acid ⁇ buffer solution having buffer capacity, ACES [N- (2-acetamido) -2- Aminoethanesulfonic acid] buffer, ADA [N- (2-acetamido) iminodiacetic acid] buffer, BES [N, N-bis (2-hydroxyethyl) -2-aminosulfonic acid] buffer, Bicine [N, N-bis (2-hydroxyethyl) glycine] buffer, Bis-Tris [bis (2-hydroxyethyl) iminotris (hydroxymethyl) methane] buffer, CAPS (N-cyclohexyl-3-aminopropanesulfonic acid
  • the pH of the buffer solution is not particularly limited, but is preferably around the original pH of the body fluid sample from the viewpoint of the stability of the body fluid sample to be diluted. In the case of blood, plasma or serum, pH 6 to 8 is preferable.
  • the dilution buffer may contain a chelating agent, antibacterial agent, preservative, coenzyme, saccharide, inhibitor and the like for the purpose of keeping the component to be measured stable.
  • Examples of chelating agents include ethylenediaminetetraacetate, citrate, and oxalate.
  • antibacterial agents and preservatives include amikacin sulfate, kanamycin sulfate, thiabendazole, sodium azide and the like.
  • Examples of coenzymes include pyridoxal phosphate, magnesium, zinc and the like.
  • Examples of the saccharide include mannitol, dextrose, oligosaccharide and the like.
  • Examples of inhibitors include sodium dodecyl sulfate, mercury, heparin and the like.
  • Stabilizers may be added in combination of a plurality of types depending on the component to be measured.
  • AST aspartate aminotransferase
  • ALT aslanine aminotransferase
  • the buffer preferably contains 0.1 to 5.0 mmol / L of ethylenediaminetetraacetic acid salt and 0.01 to 0.20 mmol / L of pyridoxalphosphate, particularly 0.5 to 3.0 mmol / L of ethylenediaminetetraacetic acid and pyridoxalphosphate. It is preferable that 0.02 to 0.10 mmol / L is contained.
  • the internal standard added to the buffer solution is not in the living body or is extremely small, does not interfere with biological components, is stable in the buffer solution, does not adsorb to the storage container, and can be detected with high accuracy.
  • the system must be available. When diluting blood, an osmotic pressure is required so that blood cells do not hemolyze, and an osmotic pressure of 250 to 500 mOsm / kg is preferable.
  • Table 1 shows the composition of a buffer solution containing maltose, which is one of internal standard substances that do not permeate the blood cell membrane, and 2-phenylethylamine, which is one of the internal standard substances that permeate the blood cell membrane. It is shown.
  • HEPES is N-2-hydroxyethylpiperazine-N′-2-ethanesulfonic acid.
  • Table 2 shows a measurement reagent for maltose, which is one of internal standard substances that do not pass through the blood cell membrane.
  • TOOS is N-ethyl-N- (2-hydroxy-3-sulfopropyl) -3-methylaniline sodium dihydrate.
  • the measurement procedure for maltose is shown below.
  • Table 3 shows a measurement reagent for 2-phenylethylamine, which is one of the internal standard substances that pass through the blood cell membrane.
  • DAOS is N-ethyl-N (2-hydroxy-3-sulfopropyl) -3,5-dimethylaniline sodium salt.
  • Blood is composed of plasma, which is a liquid component, or blood cells, which are serum and solid components, and blood cells are known to have a solid component such as a blood cell membrane and a liquid component inside thereof. Blood can be blocked from clotting by adding EDTA-2 sodium, an anticoagulant. When this whole blood is centrifuged, blood cells with heavy specific gravity settle to the bottom, and plasma is separated into the supernatant.
  • the internal standard substance that does not permeate the blood cell membrane is dissolved in the buffer solution, the internal standard substance that is originally present in the buffer solution will be distributed in the buffer solution and plasma or serum. Diluted.
  • This internal standard indicates an internal standard such as maltose that penetrates only into plasma. Since maltose is dissolved in the buffer as an anion, it dissolves in plasma and does not penetrate into blood cells.
  • the initial concentration (C0) of the internal standard substance that does not permeate the blood cell membrane in the buffer solution changes to the concentration (C1) when blood is added.
  • the dilution ratio (r1) of plasma or serum C0 / (C0 ⁇ C1) is calculated from C0 and C1.
  • the blood When the blood is diluted with a predetermined buffer, components that permeate the blood cell membrane will be distributed in the buffer and plasma or serum and blood cells and diluted.
  • the internal standard substance that is originally present in the buffer solution must be distributed in the buffer solution and plasma, or serum and blood cells. And diluted. That is, the initial concentration (C2) of the internal standard substance that permeates the blood cell membrane in the buffer solution changes to the concentration (C3) when blood is added.
  • the volume (V0) of the solution containing the internal standard is the specified amount, the internal standard that does not permeate the blood cell membrane From the calculated dilution rate (r1) of the body fluid sample component that does not permeate the blood cell membrane, the volume (V1) of the body fluid sample that does not permeate the blood cell membrane can be calculated.
  • V1 V0 / (r1-1) It can be calculated by
  • the volume (V0) of the solution containing the internal standard substance is quantified, it is calculated from the internal standard substance that permeates the blood cell membrane
  • the blood volume (V1 + V2 + V3) can be calculated from the dilution rate (r2) of the blood.
  • V1 + V2 + V3 V0 / (r2-1) It can be calculated by
  • V1 obtained from V0 and r1
  • V1, V2, and V3 can be calculated from V0, r1, and r2.
  • V1 Dilution rate of plasma or serum
  • V1 + V2 Whole blood dilution rate
  • V1 + V2 + V3 Blood dilution rate ⁇ (V0 + V1 + V2 + V3) / (V1 + V2 + V3) ⁇ Blood cell volume (V2 + V3) Blood cell dilution rate ⁇ (V0 + V2 + V3) / (V2 + V3) ⁇ Blood cell volume (V2) Dilution rate of blood cell liquid ⁇ (V0 + V2) / V2 ⁇
  • Amount of blood cell solids V3 Blood cell solid dilution rate ⁇ (V0 + V3) / V3 ⁇ Hematocrit value (%) ⁇ (V2 + V3) / (V1 + V2 + V3) ⁇ 100 (%) ⁇ or 1- (blood dilution rate-1) / (plasma dilution rate-1) Buffer
  • FIG. 2 shows a blood collection lid according to one embodiment of the present invention.
  • the collector or the person to be inspected
  • the collector stabs the finger with a thin needle, puts a small amount of blood on the surface of the finger, and as shown in FIG.
  • Blood is collected by scooping out blood that has come out on the surface of the finger from the edge of the slope 108 with the blood collection unit 102 facing upward.
  • the blood flows through the slope of the slope 108 from the fingers placed on the edge of the slope 108, flows into the concave portion 104 adjacent to the plane portion 106 via the plane portion 106 adjacent to the slope 108.
  • the flat portion 106 serves as a scale, and whether or not the blood that has entered the concave portion 104 has accumulated a predetermined amount (for example, 65 microliters) necessary for the examination has been collected up to the height of the flat portion 106. Can be easily determined. It is also possible to provide an appropriate blood collection amount by providing a blood collection amount instruction line at the boundary between the flat portion 106 and the concave portion 104. It is also possible to provide an instruction line for indicating the amount of blood collected in steps of 20 microliters to 100 microliters inside the blood sampling unit 102.
  • a predetermined amount for example, 65 microliters
  • the blood collection lid 100 is turned upside down and the blood collection unit 102 is directed downward, the blood accumulated in the recess 104 continues to be held in the recess 104 due to its viscosity and surface tension, and does not easily fall down.
  • the viscosity of blood is higher than the viscosity of water, and if blood flows down to the bottom of the recess 104, the contact area of the bottom surface is large and the viscosity of blood is larger than that of water. , It doesn't run off immediately.
  • FIG. 3 is a cross-sectional view of the blood sampling lid cut in the vertical direction along the line AA in FIG.
  • a screw structure 112 for screwing with the screw structure 206 of the blood dilution container 200 is provided inside the lid portion 110 of the blood collection lid 100. With these screw structures 112 and 206, the blood dilution container 200 can be sealed with the lid 110 of the blood collection lid 100.
  • the angle of the slope 108 with respect to the horizontal edge of the blood sampling part 102 ( ⁇ in FIG. 3) can be about 50 degrees to about 90 degrees in order to guide blood smoothly into the recess 104. Preferably, the angle ⁇ can be about 70 degrees to about 85 degrees.
  • the bottom surface of the recess 104 can be formed in an uneven shape.
  • the uneven bottom surface increases the surface area that the blood entering the recess 104 comes into contact with, and the blood is less likely to spill due to the viscosity or surface tension of the blood even when the blood collection portion 102 of the blood collection lid 100 is directed downward. This prevents blood from spilling out of the blood dilution container 200 when the blood collection unit 102 is housed in the blood dilution container 200.
  • the size of the recess 104 can be about 5 mm in diameter and about 3.3 mm in depth. Moreover, the diameter of the cylindrical blood collection part 102 can be about 9 mm. As another example, the bottom area of the recess 104 can be about 0.3 mm 2 to 0.6 mm 2, and preferably about 0.35 mm 2 to 0.45 mm 2 . As yet another embodiment, blood coagulation is prevented by applying and coating an anticoagulant EDTA salt or heparin on the inner surface of the blood collection unit 102, particularly the bottom and inner walls of the recess 104. It is also possible.
  • the ratio (surface area / volume) of the surface area of the recess 104 and the volume of blood (surface area / volume) that is actually in contact with the blood becomes 1.1 (mm 2 / mm 3 ) or more
  • the recess 104 can also be formed so as to be preferably 1.2 to 2.0 (mm 2 / mm 3 ).
  • FIG. 4 shows a cross-sectional view of another embodiment in which the angle of the slope 108 of the blood collection lid 100 is changed.
  • the angle of the slope 108 ( ⁇ in FIG. 4) with respect to the horizontal edge of the blood collection unit 102 can be a large angle of 90 degrees or more. For example, it can be 95 degrees to 115 degrees. Thereby, blood can be dropped into the recess 104 more smoothly.
  • FIG. 5 is a view showing a blood collection lid according to another embodiment of the present invention.
  • the basic configuration is the same as that of the blood collection lid shown in FIG. 2, but the recess 104 is arranged at a position close to the inner wall of the blood collection unit 102.
  • a part of the inner wall of the recess 104 is common with a part of the inner wall of the blood collection part 102.
  • a flat surface can be formed at a portion where the inner walls are common, and the sampling wall 114 can be provided.
  • the flat collection wall 114 extends vertically from the edge of the blood collection unit 102 to the bottom surface of the recess 104.
  • Collection of blood from the fingers is performed using a collection wall 114 in which a part of the inner wall of the recess 104 and a part of the inner wall of the blood collection unit 102 are common.
  • a collection wall 114 in which a part of the inner wall of the recess 104 and a part of the inner wall of the blood collection unit 102 are common.
  • the blood collection unit 102 includes, in addition to the concave portion 104, a flat portion 106 adjacent to the outer periphery of the concave portion 104, a first slope 116 adjacent to the outer peripheral inner wall of the flat portion 106, A second slope 118 adjacent to the slope 116 is provided.
  • FIG. 6 is a cross-sectional view of the blood sampling lid cut in the vertical direction along the line BB in FIG.
  • the first slope 116 has a gentler slope than the second slope 118.
  • It is also possible to instruct an appropriate blood collection amount by providing a blood collection amount instruction line at the boundary between the flat portion 106 and the recess 104.
  • the first slope 116 and the second slope 118 can be provided with an indication line indicating the amount of blood collected to have a scale function.
  • the blood sampler can easily determine whether or not the blood that has entered the recess 104 has reached a prescribed amount necessary for the examination.
  • an instruction line can be provided so that the minimum necessary blood collection amount is indicated at the boundary between the concave portion 104 and the flat portion 106 and an appropriate blood collection amount is indicated at the boundary between the inner wall of the flat portion 106 and the first slope 116.
  • the surface area of the flat surface portion 106, the first slope 116, and the second slope 118 is relatively large, so that the blood flow on the surface is considered in consideration of blood viscosity and surface tension. Can be relatively slow. Therefore, even if the blood collection lid 100 is turned upside down and the blood collection unit 102 is directed downward, it is possible to prevent blood from spilling from the flat portion 106, the first slope 116, and the second slope 118 side.
  • FIG. 7 is a view showing a blood collection lid according to another embodiment of the present invention.
  • the blood collection unit 102 of the blood collection lid 100 shown in FIG. 7 includes a straight collection wall 120 having a flat inner wall. Blood can be easily collected by applying a finger that has pierced a needle and squeezed blood to the straight edge of the collection wall 120.
  • FIG. 8 is a cross-sectional view of the blood collection lid cut in the vertical direction along the line CC in FIG.
  • the roles of the concave portion 104, the flat portion 106, the first slope 116, the second slope 118, and the collection wall 120 are the same as those of the blood collection lid 100 shown in FIGS.
  • FIG. 9 is a view showing a blood collection lid according to another embodiment of the present invention.
  • the edge of the inner wall of the blood collection unit 102 is a straight line, and the straight line forms a polygonal shape (an octagon in FIG. 9).
  • a portion where a part of the inner wall of the blood collection unit 102 and a part of the inner wall of the recess 104 are common is used as the collection wall 122 for collecting blood.
  • FIG. 10 is a diagram illustrating one embodiment of a blood collection lid having a collection wall with capillaries.
  • One or more capillaries 124 can be provided in the blood collection portion 102 of the blood collection lid 100.
  • the capillary 124 is formed by providing a linear groove extending vertically from the edge of the blood collection unit 102 to the bottom surface of the recess 104 on the surface of the collection wall 114.
  • three capillaries 124 with straight grooves are provided.
  • the blood sample collection device can be used in the field of clinical tests using body fluid samples because the subject can collect blood samples themselves. It goes without saying that the blood sample collecting device according to the present invention can be used as a body fluid sample collecting device for collecting other body fluids (saliva, tears, sweat, etc.).

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Abstract

La présente invention concerne un instrument de collecte d'échantillon de fluide corporel qui a une structure simple, comprenant uniquement les deux éléments suivants : un capuchon de collecte de fluide corporel ayant un moyen pour collecter un fluide corporel, tel que le sang, sans utiliser de tige en fibre ; et un récipient de dilution de fluide corporel pour diluer le fluide corporel avec une solution tampon de dilution de fluide corporel. Ledit instrument de collecte d'échantillon de fluide corporel est caractérisé par le fait qu'il comprend les éléments suivants : un capuchon de collecte de fluide corporel qui comprend une section de collecte de fluide corporel cylindrique et une section capuchon ; et un récipient de dilution de fluide corporel, dans lequel la section de collecte de fluide corporel peut être insérée et le capuchon de collecte de fluide corporel peut être vissé et fermé de façon à obturer de manière étanche le récipient de dilution de fluide corporel. L'instrument de collecte d'échantillon de fluide corporel est également caractérisé par le fait que : l'intérieur de la section de collecte de fluide corporel a une pente le long de laquelle s'écoule le fluide corporel collecté, et une concavité pour contenir le fluide corporel qui s'est écoulé de ladite pente ; et le rapport (aire/volume) de l'aire (en mm2) de l'échantillon de fluide corporel au volume de récipient (mm3) de l'échantillon de fluide corporel est supérieur ou égal à 1,1 (mm2/mm3).
PCT/JP2014/065627 2014-06-12 2014-06-12 Instrument de prélèvement d'échantillon de sang Ceased WO2015189960A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2014/065627 WO2015189960A1 (fr) 2014-06-12 2014-06-12 Instrument de prélèvement d'échantillon de sang

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2014/065627 WO2015189960A1 (fr) 2014-06-12 2014-06-12 Instrument de prélèvement d'échantillon de sang

Publications (1)

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WO2015189960A1 true WO2015189960A1 (fr) 2015-12-17

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019050802A1 (fr) * 2017-09-05 2019-03-14 Beckman Coulter, Inc. Collecte et préparation d'échantillons de sang pour des diagnostics sur point d'intervention
US11883170B2 (en) 2018-05-01 2024-01-30 Becton, Dickinson And Company Biological fluid micro-sample management device
WO2024261167A1 (fr) 2023-06-21 2024-12-26 Daklapack Europe B.V. Collecteur de sang insérable avec élément de type pelle en saillie

Citations (10)

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Publication number Priority date Publication date Assignee Title
JPS492184U (fr) * 1972-04-06 1974-01-10
JPS55500366A (fr) * 1978-05-26 1980-06-26
JPS6184846U (fr) * 1984-11-12 1986-06-04
JPH01219561A (ja) * 1988-02-26 1989-09-01 Terumo Corp 栓体およびそれを備えた試料採取用管体
US5038794A (en) * 1987-11-16 1991-08-13 Valkenburg Nanci L Van Capillary blood collector and method
JPH07151750A (ja) * 1993-07-21 1995-06-16 Eastman Kodak Co 検査要素への液体試料の適用方法および装置
JPH11318871A (ja) * 1998-05-20 1999-11-24 Dainabotto Kk 定量採血具
JP2000232972A (ja) * 1999-02-15 2000-08-29 Daikin Ind Ltd 検体点着用具
JP2006322829A (ja) * 2005-05-19 2006-11-30 Leisure Inc 未定量の生体試料の定量分析方法
WO2008136400A1 (fr) * 2007-04-27 2008-11-13 National University Corporation Kyoto Institute Of Technology Centrifugeuse grand volume pour produits sanguins

Patent Citations (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS492184U (fr) * 1972-04-06 1974-01-10
JPS55500366A (fr) * 1978-05-26 1980-06-26
JPS6184846U (fr) * 1984-11-12 1986-06-04
US5038794A (en) * 1987-11-16 1991-08-13 Valkenburg Nanci L Van Capillary blood collector and method
JPH01219561A (ja) * 1988-02-26 1989-09-01 Terumo Corp 栓体およびそれを備えた試料採取用管体
JPH07151750A (ja) * 1993-07-21 1995-06-16 Eastman Kodak Co 検査要素への液体試料の適用方法および装置
JPH11318871A (ja) * 1998-05-20 1999-11-24 Dainabotto Kk 定量採血具
JP2000232972A (ja) * 1999-02-15 2000-08-29 Daikin Ind Ltd 検体点着用具
JP2006322829A (ja) * 2005-05-19 2006-11-30 Leisure Inc 未定量の生体試料の定量分析方法
WO2008136400A1 (fr) * 2007-04-27 2008-11-13 National University Corporation Kyoto Institute Of Technology Centrifugeuse grand volume pour produits sanguins

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019050802A1 (fr) * 2017-09-05 2019-03-14 Beckman Coulter, Inc. Collecte et préparation d'échantillons de sang pour des diagnostics sur point d'intervention
CN111194241A (zh) * 2017-09-05 2020-05-22 拜克门寇尔特公司 收集并准备用于即时诊断的血液样品
JP2020532739A (ja) * 2017-09-05 2020-11-12 ベックマン コールター， インコーポレイテッド 診療現場診断のための血液サンプルの収集および調製
JP7144511B2 (ja) 2017-09-05 2022-09-29 ベックマン コールター， インコーポレイテッド 診療現場診断のための血液サンプルの収集および調製
US11666917B2 (en) 2017-09-05 2023-06-06 Beckman Coulter, Inc. Collection and preparation of blood samples for point-of-care diagnostics
US11883170B2 (en) 2018-05-01 2024-01-30 Becton, Dickinson And Company Biological fluid micro-sample management device
WO2024261167A1 (fr) 2023-06-21 2024-12-26 Daklapack Europe B.V. Collecteur de sang insérable avec élément de type pelle en saillie
NL2035134B1 (en) * 2023-06-21 2025-01-07 Daklapack Europe B V lnsertable blood collector with protruding scoop member.

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