WO2024024039A1

WO2024024039A1 - Blood storage container and blood collection instrument

Info

Publication number: WO2024024039A1
Application number: PCT/JP2022/029137
Authority: WO
Inventors: 肇岩澤
Original assignee: ナッジヘルステック株式会社
Priority date: 2022-07-28
Filing date: 2022-07-28
Publication date: 2024-02-01
Also published as: TWI828265B; JP7261526B1

Abstract

Provided is a blood storage container for storing and preserving collected blood, the blood storage container comprising: a storage container configured to have a hollow shape; and a sealed container attached to an end portion of the storage container. The storage container has: a blood collection space in which a first opening to be connected to a blood collection chip is formed on one side in an axial direction; a separation flow path which is continuous with the other end side in the axial direction of the blood collection space and which is formed to have a cross section smaller than that of the blood collection space; and a preservation space which is continuous with the separation flow path on the other side in the axial direction, which has a second opening formed on the other side in the axial direction, and which is formed to have a cross section larger than that of the separation flow path. The sealed container has: a dial part which is movable along an axial direction so as to cover the second opening on the other side in the axial direction of the storage space of the storage container; and a sealed container shaft part which is formed to protrude inside the dial part and which is freely movable in the axial direction in a state of being in contact with an inner surface of the preservation space.

Description

Blood storage containers and blood collection equipment

TECHNICAL FIELD The present invention relates to a blood sampling device and a blood storage container used for collecting minute amounts of blood and preparing, storing, and analyzing blood samples.

Blood tests and other tests that analyze human body fluids as samples are performed to closely examine the manifestation of diseases and examine the state of health of the body. In general, blood collection is known as venous blood collection, such as syringe collection by puncturing a brachial vein. Venous blood sampling may be difficult for infants, small blood vessels, or fragile patients. In such cases, it is known to collect peripheral blood from a fingertip or the like as a test sample.

Test samples required for blood tests in various fields such as chemistry, immunology, and hematology generally require a volume of several microliters to several tens of microliters per test item. In addition, techniques have been widely disclosed that allow a trace amount of blood to be collected and analyzed with high sensitivity.

In recent years, disease mechanisms involving extracellular vesicles, exosomes, are becoming clearer through liquid biopsy technology that detects genetic mutations in components contained in body fluids. It has been confirmed that various cells in the body load functional molecules such as proteins, microRNAs, and mRNAs into exosomes and send messages to nearby and distant cells via exosomes. Micro blood tests that collect a small amount of blood are expected to be applied to new testing technologies such as exosome analysis, and can be used to detect the risk of diseases such as cancer at an early stage for ordinary people who are at risk of asymptomatic diseases. It is expected that this will enable the screening of

In general, when collecting a small amount of blood, a method is known in which a predetermined amount of blood is aspirated from a small amount of blood bled by pricking a fingertip with a lancet using a blood sampling tool or the like. This method of collecting peripheral blood samples is minimally invasive, reduces the risk of contamination with body blood and hemolysis due to insufficient blood sampling capacity or pressure during bleeding, and collects as small a volume as possible that is necessary and sufficient for testing. It is advisable to take blood.

In the field of blood testing, including biochemistry and immunology, in order to store and analyze collected blood as a test sample, it is generally necessary to prepare blood cells (red blood cells, white blood cells, platelets) that make up about 45% of the blood. It is necessary to separate blood cells from plasma or serum, and centrifugation techniques are widely used as a standard method for separating blood cells and plasma (serum).

Furthermore, in venous blood collection, it is known that 1 ml or more of blood is collected using a syringe, and the blood cells and plasma are centrifuged using a separating agent sealed in a test tube in advance. However, when collecting a small amount of peripheral blood in which several tens of microliters of blood is collected, it is impossible to seal the blood in a small container with a diameter of several millimeters and perform centrifugation using a separating agent in the same way as in venous blood collection test tubes. Have difficulty. During centrifugation, due to the viscosity of the separating agent, a portion of the blood near the separation surface remains mixed with the separating agent and remains on the wall of the syringe, causing a situation where plasma (serum) and blood cells cannot be properly separated. There is. Furthermore, when physical centrifugation is performed using a separating agent, the separated lower blood cells cannot be used as a sample, so if blood cell analysis is required, blood must be collected by puncture twice.

When using a small blood storage container in a micro blood test, it is common to quickly centrifuge the whole blood after blood collection without using a separating agent to obtain a test sample. However, when dispensing the upper plasma (serum) after centrifugation as a test sample, it is necessary to avoid mixing and aspiration of blood cell components, so it is not possible to aspirate the sample near the separation surface. This significantly reduces sample yield. For example, when 60 μl of blood is centrifuged using a tube with a diameter of 4 mm, and the blood cell ratio is 45%, the height of the upper plasma is approximately 2.15 mm, and 1 mm from the separation surface is the practical suction limit. Considering this, the amount of plasma that can be aspirated on average is about 15 μl, and the plasma yield is about 25% even though the volume ratio of the plasma sample to the total blood volume is 55%. Therefore, when performing a minute blood test from a fingertip or the like, it is common to collect approximately four times the amount of sample of plasma or the like required for the test.

In self-drawn blood tests, a membrane separation method is sometimes used that uses multiple permeable membranes to separate plasma from a small amount of blood sample, rather than centrifugation. The blood collection device used in this method sucks the blood collected at the punctured fingertip into a filter containing an anticoagulant, and then drops the filter into a buffer solution and shakes it. A test sample is prepared by filtering the mixed solution of blood and buffer solution through a membrane to separate blood cells and plasma. However, the test sample prepared by this method is a plasma sample obtained by diluting whole blood in a non-quantitative manner and separating it by membrane permeation. Spilling of blood cell solution into the diluent may occur. For this reason, accurate item concentration measurement cannot be performed, and the plasma dilution rate is unknown. In general, a method is used in which the concentration of an external substance dissolved in the diluent is used as a marker and the dilution rate is estimated from the difference in marker concentration before and after dilution. There are problems such as the unavoidable change in concentration over time, and the accuracy and reliability of this measurement method is low, so it has not been adopted as a standard testing method.

A device called a capillary, which utilizes capillary action, is generally used to collect blood collected from a fingertip or the like. Blood stored in a fingertip or the like is subjected to a force that tries to shrink the liquid level due to surface tension, and as a result, the liquid level is pushed up. Since the force pushing up the liquid level is equal to the vertical component of the surface tension near the wall surface, a capillary phenomenon occurs that pushes up the liquid level inside the capillary until this force and the weight of the sucked up liquid balance out. In capillary blood collection, the tip is brought into contact with the surface of blood cells, and an appropriate amount of minute blood is collected using capillary action. Capillaries are generally straight glass tubes with a length of about 10 mm, an inner diameter of 1 mm or less, and a thickness of about 0.2 mm, and are used by third parties such as doctors and nurses to collect blood from a few microliters to several tens of microliters. It is often done.

When collecting a relatively large amount of peripheral blood, such as 100 μl or more, a method is sometimes used in which blood collected at a fingertip or the like is directly poured into a storage container with a tongue. This method is generally performed by a skilled third party, such as a doctor or nurse, because the blood that has been sufficiently collected in the fingertip must be stored in a storage container without flowing or falling.

Blood sampling devices for self-collecting small amounts of blood from a fingertip or other source without relying on a third party are generally not capillaries or containers with tongues, but are often dedicated blood sampling devices designed for self-collection. . For example, a plastic tube having a capillary suction section with a tip diameter of approximately 0.5 mm to 1.0 mm and a tapered conical outlet structure connected to the capillary suction section may be used. The tip of a blood sampling device is brought into contact with the blood collected at the fingertip after puncturing it with a lancet or the like from diagonally below, and the blood is suctioned by capillary action and flows into the container under the pressure of its own weight. However, since the wall surface of plastic has hydrophobic properties, it becomes water-repellent when the tip comes into contact with blood, and capillary suction force cannot be exerted as it is. Therefore, when a plastic tube is generally used as a blood sampling device that utilizes capillarity, countermeasures are taken to ensure contact suction, such as making the inner wall surface hydrophilic.

When collecting blood from a fingertip, etc., it is inevitable that the tip of the blood sampling device comes into contact with the accumulated blood, and at this time friction occurs between the surface of the collected liquid and the surface of the fingertip. When this happens, the surface tension of the pooled blood is lost. If blood is continuously pushed out from the fingertip puncture hole in this state, the pushed blood will not be able to stay on the fingertip and will flow down the fingertip surface. This phenomenon makes it difficult to self-collect a small amount of peripheral blood from a fingertip, and as a countermeasure, a donut-shaped tape that is attached to the fingertip puncture site is sometimes used. The following

Patent Documents

1 and 2 have already been proposed as techniques related to this type of general blood collection.

Japanese Patent Application Publication No. 2012-185146 Japanese Patent Application Publication No. 2018-105830

When self-collecting a small amount of blood for the purpose of various blood tests, a method often used is to puncture the fingertip with a lancet and aspirate the small amount of blood collected at the puncture site with a plastic blood collection tip. In such a dedicated blood sampling device for self-collection, the amount of blood necessary for the test, usually several tens of microliters to 100 microliters, flows into the hemolysis device by creating an inclined shape like a pipette tip from the capillary tip. . However, since the wall surface of plastic has hydrophobic properties, water repellency occurs when the tip comes into contact with blood, and capillary suction force does not work as it is, so a suction tool is used to draw blood into the hemolysis tool. It is necessary to have an inflow.

When conducting various component concentration tests using a small amount of blood saved after blood collection, generally, the separated plasma portion is diluted with a diluent and the diluted plasma solution is used as a sample, and the blood cell portion is hemolyzed to measure the components. do. When diluting separated plasma, a fixed amount of plasma is dispensed, and the liquid is diluted with a fixed amount of diluent to create a constant dilution plasma solution. If a constant dilution plasma solution is measured as a test sample, the reported value shall be the actual measured value multiplied by the dilution rate. In this dilution operation, accurate dispensing of a predetermined amount is essential to maintain inspection accuracy. However, if the plasma part and the blood cell part are not physically separated and there is a direct contact separation surface between the blood cells and plasma, for example, when 30 μl of blood is centrifuged in a 3 mm diameter container, The upper plasma volume is only 2 mm deep, making it difficult to dispense accurately and in a sufficient amount.

If a blood sample is left without physically separating the blood cells and plasma (serum) after collection or centrifugation, components in the blood cells, such as glucose and urea nitrogen, will spill out into the plasma (serum) portion and affect the analysis results. influence Therefore, when it takes a certain amount of time to carry out a test, such as when transporting a specimen after blood collection, it is necessary to physically separate plasma and blood cells. For this separation, a centrifugal separation technique using a separating agent is generally used. However, when centrifugation using a separation agent is performed in a small blood collection device or storage container with an inner diameter of several mm or less than 10 mm, which is used for general micro-blood collection, the separation surface cannot be reliably established, resulting in separation using a separation agent. It is difficult to perform this stably. Furthermore, when plasma separation is performed using a separating agent, the blood cells separated under the separating agent cannot be used as an analysis sample, so if blood cell analysis is required, separate blood sampling is required.

In blood tests, the amount of blood required for analysis varies depending on the test items and their combinations. In brachial vein blood sampling, various tests can be performed by generally collecting a quantitative amount of blood of 1 ml or more, but on the other hand, much of the collected blood becomes surplus and is discarded. In micro blood tests, in order to reduce the invasiveness of the user and make the most of the limited amount of blood collected, we set a sample concentration range for each item that allows for highly sensitive measurements. Dilute the sample within the chamber, secure the amount of sample necessary for the test, and perform the measurement. However, in general micro blood collection, the blood collection amount and dilution rate (diluted sample amount) are set fixedly. For this reason, inspection items and item combinations have to be fixed, making it difficult to set items flexibly according to the inspection purpose.

In view of the above-mentioned problems, the present invention has been developed to quickly and easily collect a small amount of blood stored at a fingertip, etc. according to the required amount of blood that changes depending on the test purpose, and add the blood in the same container. By mixing agents, physically separating and storing blood cells and plasma, and making it possible to accurately dilute the sample without dispensing a fixed amount, the minimum amount of plasma can be used as an analysis sample, allowing for blood collection and testing operations. The purpose of the present invention is to provide a blood storage container and a blood sampling device to reduce the burden and stably and efficiently perform tests related to blood item analysis.

One aspect of the present invention is a blood storage container that stores and preserves collected blood, and includes a storage container configured in a hollow shape and an airtight container attached to an end of the storage container. The container is continuous with a blood collection space in which a first opening connected to a blood collection chip is formed on one axial side, and the other end of the blood collection space in the axial direction, and has a smaller cross section than the blood collection space. a storage space whose other side in the axial direction is continuous with the separation flow path, a second opening is formed on the other side in the axial direction, and whose cross section is larger than that of the separation flow path; The airtight container has a lid portion movably placed along the axial direction so as to cover the second opening on the other axial side of the storage space of the storage container, and a lid portion on the inside of the lid portion. The blood storage container has a closed container shaft that is formed to protrude and is movable in the axial direction while in contact with the inner surface of the storage space.

According to the present invention, it is possible to reduce the burden of blood collection work and testing work, and to stably and efficiently implement tests related to blood item analysis.

FIG. 1 is a longitudinal sectional view showing an assembled state of a blood sampling device according to an embodiment of the present invention. FIG. 2 is an exploded perspective cross-sectional view showing the configuration of a blood sampling device. FIG. 2 is a cross-sectional view showing the configuration of a container lid that closes the containment container. FIG. 3 is a cross-sectional view showing how the blood sampling device is used. FIG. 2 is a cross-sectional view showing a blood sampling method using a blood sampling device. FIG. 3 is a cross-sectional view showing how to use the blood sampling device. FIG. 2 is a cross-sectional view showing a centrifugation method using a blood storage container. FIG. 3 is a cross-sectional view showing a method of dispensing blood cells from a blood storage container. FIG. 3 is a cross-sectional view showing a method of measuring plasma in a blood storage container. FIG. 3 is a cross-sectional view showing a method for discharging blood from a blood sampling device. FIG. 7 is an exploded perspective view showing the configuration of a blood sampling device according to a modified example. FIG. 7 is a perspective cross-sectional view showing the configuration of a blood sampling chip according to a modified example.

Hereinafter, one embodiment of a blood storage container and a blood sampling device using the same according to the present invention will be described with reference to the drawings. In the following description, XYZ axes are set orthogonal to each other, the Z-axis direction is referred to as the axial direction, the +Z side of the Z-axis is referred to as one axial side, the -Z side is referred to as the other axial side, etc.

As shown in FIG. 1, the blood sampling device 1 includes a blood sampling chip 400 for collecting blood, and a blood storage container 10 to which the blood sampling chip 400 is attached. The blood storage container 10 is formed to store and preserve blood collected by the blood collection chip 400. The blood storage container 10 includes a storage container 100 in which a blood collection space 102 for storing blood is formed, a closed container 300 in which a storage space 302 for storing blood is formed, and a dial part 350 provided in the closed container 300. Equipped with. The blood storage container 10 is sealed with a container lid 200, which will be described later, in place of the blood collection chip 400.

The storage container 100, the sealed container 300, and the blood collection chip 400 are preferably made of a transparent, hard polymer compound material such as polycarbonate or acrylonitrile butadiene styrene, so that blood collection, blood separation, and blood storage can be monitored from the outside. Can be easily recognized visually. The containment vessel 100 and the closed vessel 300 communicate with each other through a narrow separation channel 10R having a predetermined length.

A small amount of blood is sealed in the storage container 100. After blood collection, the blood storage container 10 is centrifuged as described below, and upon completion of centrifugation, the plasma portion is stored in the storage container 100 and the blood cell portion is stored in a sealed container 300 in a physically separated state. The blood storage container 10 is provided with a stopper 250, which is a mechanism for sealing the separation channel 10R after centrifugation.

As described later, the stopper 250 seals the separation channel 10R based on a pushing operation. The stopper 250 closes the separation channel 10R and maintains a physically separated state in which the plasma part stored in the storage container 100 and the blood cell part stored in the closed container 300 do not mix again.

The storage container 100 is, for example, formed in a cylindrical shape. A blood collection space 102 is formed inside the storage container 100 to store a small amount of blood. The cross-sectional shape (cross section) of the blood collection space 102 perpendicular to the axial direction is circular. A circular first opening 101 is formed at one end of the blood collection space 102 in the axial direction. A blood sampling chip 400, which will be described later, is connected to the first opening 101. A radially protruding flange portion 101F is formed on the outer circumferential surface of one end of the blood collection space 102 in the axial direction.

The blood collection chip 400 is removed and a container lid 200 (see FIG. 3), which will be described later, is attached to the first opening 101. The blood collection space 102 is sealed by the container lid 200. Thereby, the blood storage container 10 can perform all testing operations from blood collection to sample transportation, centrifugation, and sample measurement without dispensing the sample. A first tapered portion 103 whose cross-sectional area decreases toward the end is formed on the other side in the axial direction of the blood collection space 102 . The first tapered portion 103 is formed as a solution reservoir.

The other end of the first tapered portion 103 in the axial direction is continuous with a separation flow path 10R, which will be described later. That is, the blood collection space 102 is formed so as to be continuous with the separation channel 10R on the other side in the axial direction. A closed container 300 is provided on the other axial side of the containment container 100 .

The blood stored in the storage container 100 is stored in the closed container 300. The closed container 300 is formed into a cylindrical shape. A storage space 302 for storing blood is formed inside the closed container 300. The cross-sectional shape (cross section) of the storage space 302 perpendicular to the axial direction is circular. A second tapered portion 303 whose cross-sectional area increases toward the storage space 302 is formed on one side of the storage space 302 in the axial direction. One axial end of the second tapered portion 303 is continuous with the separation channel 10R. The storage space 302 is continuous with the blood collection space 102 via the separation channel 10R.

The separation channel 10R is formed so that the blood collection space 102 and the storage space 302 are continuous. The cross section of the separation channel 10R is smaller than the cross section of the blood collection space 102. The cross section of the separation channel 10R is formed smaller than the cross section of the storage space 302. That is, the cross section of the storage space 302 is formed larger than the cross section of the separation channel 10R. The storage space 302 is formed in a cylindrical shape.

A circular second opening 301 is formed at the other end of the storage space 302 in the axial direction. A protrusion 304 having a second opening 301 and protruding toward the other axial side is formed at the other end of the closed container 300 in the axial direction. The outer circumferential surface 305 of the protrusion 304 is formed to bulge in the radial direction. A dial portion 350 is rotatably fitted into the protrusion 304 .

The dial portion 350 includes a plunger 360 that protrudes along the axis L direction. A fitting portion 351 that fits into the protrusion 304 is provided at one end of the dial portion 350 in the axial direction. An inner circumferential surface 352 of the fitting portion 351 is formed to be concave in the radial direction. The inner circumferential surface 352 of the fitting portion 351 fits into the outer circumferential surface 305 of the protruding portion 304 . Thereby, the dial part 350 is rotatably provided on the other axial side of the closed container 300. Two slits 354 are formed in the dial portion 350 symmetrically with respect to the axis L so as to cut out the outer circumferential surface and the inner circumferential surface along the axis L direction. The slit width of the slit 354 is reduced by pressing the outer peripheral surface. The fitting portion 351 deforms to expand in the radial direction as the slit width decreases, and the fitting between the inner circumferential surface 352 and the outer circumferential surface 305 of the protruding portion 304 is released. The dial portion 350 is removed from the closed container 300 together with the plunger 360 when the fitting portion 351 and the outer circumferential surface 305 of the protruding portion 304 are disengaged. That is, when the outer peripheral surface of the dial portion 350 is strongly pressed from both lateral directions, the width of the slit 354 is reduced, the fitting portion 351 is widened, and the dial portion 350 is removed from the protruding portion 304. Since the plunger 360 is also removed from the closed container 300 together with the dial portion 350, the plunger 360 can be pulled out from the storage space 302.

A through hole 353 is formed in the dial portion 350 along the axis L direction. A thread groove 353M is formed in the through hole 353. A threaded portion 361 formed on the plunger 360 is screwed into the through hole 353 . Thereby, the plunger 360 is provided inside the dial portion 350 so as to protrude along the axial direction.

A head 362 having a circular cross section is formed at one end of the plunger 360 in the axial direction. The outer diameter of the head 362 is slightly smaller than the inner diameter of the storage space 302. The head 362 is formed into a piston shape. The head 362 is configured to be able to slide along the axis L while being in close contact with the inner surface of the storage space 302 .

The head 362 is inserted into the storage space 302 from the second opening 301. With the above configuration, when the dial part 350 is rotated around the axis L, the screw part 361 rotates with respect to the through hole 353, and the plunger 360 moves along the axis with the head 362 in close contact with the inner surface of the storage space 302. It becomes movable along the L direction.

The storage container 100 and the sealed container 300 are formed with a perfect circular cross section in consideration of the ease of the manufacturing process and the rotation of the threaded portion 361 and the threaded groove 353M, as well as the rotation of the plunger 360 due to the rotation. be done. The containment vessel 100 and the closed vessel 300 may be formed in a cross-sectional shape other than a perfect circle at a portion that does not involve relative rotation. The containment vessel 100 and the sealed container 300 may have, for example, a polygonal or non-circular cross-sectional shape on the outer circumferential surface for the purpose of improving handling properties, or may have irregularities formed on the outer circumferential surface as appropriate. Good too.

In the separation channel 10R, through holes 10S are continuously formed in a direction perpendicular to the axis L. A stopper 250 is fitted into the through hole 10S. The stopper 250 includes a pressing portion 251 for performing a pushing operation, and a sliding portion 252 inserted into the through hole 10S. When the pressing part 251 is pressed, the sliding part 252 moves along the through hole 10S, closes the separation flow path 10R, and blocks the blood collection space 102 and the storage space 302. When the pressing part 251 is pulled from this state, the sliding part 252 moves along the through hole 10S and opens the separation channel 10R. Thereby, the blood collection space 102 and the storage space 302 communicate with each other.

That is, the stopper 250 is provided in the separation flow path 10R so as to be movable in a direction intersecting the axis L direction, and is provided so as to communicate with or shield the blood collection space 102 and the storage space 302. By pushing this stopper 250 into the through hole 10S, the separation channel 10R is closed. By closing the separation channel 10R using the stopper 250, it is possible to maintain a physically separated state in which the plasma part stored in the storage container 100 and the blood cell part stored in the closed container 300 do not mix again. can.

The blood collection chip 400 is detachably attached to one axial side of the storage container 100 so as to close the first opening 101. The blood collection chip 400 is formed into a cylindrical shape having a conical shape as a whole. The blood sampling chip 400 includes a blood sampling section 401 provided on one axial side, and a connecting section 405 provided on the other axial side.

The blood sampling section 401 is formed in a tapered shape in which the cross-sectional area of the blood sampling section 401 decreases toward one end in the axial direction. In the blood sampling chip 400, a flow path 430 (see FIG. 4) is formed along the axis L direction. A blood sampling opening 403 is formed at one axial end of the blood sampling section 401 so that a part of the inner circumferential surface 430H of the flow path 430 is exposed. A connection opening 405H that communicates with the blood collection opening 403 is formed at the other axial end of the connection portion 405 of the blood collection unit 401 .

The blood sampling opening 403 is formed to be sealed by covering it with a cap 500, which will be described later. The blood sampling opening 403 is formed to have an inner diameter of 0.5 mm to 1.5 mm, for example. The blood sampling opening 403 is formed so that blood serving as a sample comes into contact with a portion of the exposed inner circumferential surface of the flow path 430, so that the blood flows into the flow path 430 based on capillary action.

The blood sampling opening 403 is formed in a shape cut at an angle with respect to the axis L direction. The blood sampling opening 403 is formed by cutting an angle in the range of 30 degrees to 45 degrees, preferably around 40 degrees with respect to the axis L direction. The blood sampling opening 403 is formed in an inclined shape that is linear or curved in accordance with the shape of the blood droplet with respect to the axis L direction.

Generally, when a plastic tube is used as a blood collection device that utilizes capillary action, a countermeasure for contact suction is required, such as making the inner wall surface hydrophilic. In contrast, the blood sampling section 401 has a blood sampling opening 403 formed therein, thereby eliminating the need for hydrophilic treatment in the channel 430 and allowing blood to flow into the channel 430 based on capillary action. Can be done.

Further, on the inner or outer periphery of the blood sampling section 401, an upward mark 409 indicating the upward direction of the blood sampling opening 403 at the time of blood sampling, and a measurement line 408 serving as an index for confirming the amount of blood to be sampled from the outside are formed. The metering lines 408 are marked, for example, at 50 μl and 100 μl.

The connecting portion 405 is provided on the other axial side of the blood sampling chip, and is inserted into the blood sampling space 102 from the first opening 101 on one axial side of the storage container 100 . The outer circumferential surface of the connecting portion 405 is formed to have an outer diameter that allows the connecting portion 405 to be inserted densely into the first opening 101 of the containment vessel 100 . The connecting portion 405 is removably attached to the containment vessel 100 so as to close the first opening 101 . At least one first groove 406 is formed along the axial direction on the outer peripheral surface of the connecting portion.

For example, two to four first groove portions 406 are formed, and the width is approximately 1 mm. The first groove portion 406 is formed to function as an air vent during blood suction and container storage of collected blood. A stepped portion 407 that contacts the flange portion 101F is formed around the connecting portion 405. The stepped portion 407 is formed to have a larger outer diameter than the outer diameter of the outer peripheral surface of the connecting portion.

The other axial side of the inner peripheral surface 430H of the blood collection chip 400 is a connection opening 405H that communicates with the opening 140 of the storage container. The connection opening 405H is formed to have an inner diameter of 8 mm to 15 mm, for example. Blood collection chip 400 is replaced with container lid 200 at first opening 101 .

As shown in FIG. 3, the container lid 200 is formed to close the first opening 101. The outer diameter of the outer circumferential surface of the container lid 200 is formed to fit tightly into the inner circumferential surface of the first opening 101. A radially projecting flange portion 220 is formed at one end of the container lid 200 in the axial direction. The flange portion 220 contacts the flange portion 101F around the first opening 101 of the containment vessel 100. A disk-shaped bottom portion 210 that closes the first opening 101 is formed at the other end of the container lid 200 in the axial direction.

The container lid 200 is inserted into the blood collection space 102 of the storage container 100 to a predetermined depth through the first opening 101, and seals the blood collection space 102. With the above configuration, the blood sampling device 1 can store the sample aspirated by the blood sampling chip 400 in the storage container 100. By attaching a container lid 200 to the storage container 100, the sample can be centrifuged and the centrifuged plasma can be sealed.

The blood sampling device 1 can store and seal centrifuged blood cells in a closed container 300 provided at the lower part of the storage container 100 through the separation channel 10R. The airtight container 300 can store and seal centrifuged blood cells so that the amount of blood cells can be adjusted. In the storage container 100, an additive 21, which will be described later, containing an anticoagulant such as EDTA, heparin, sodium citrate, and sodium fluoride can be preliminarily sealed or coated on the inner wall surface as shown in FIG.

As shown in FIG. 4, instead of enclosing or coating the additive 21, the storage container 100 can be filled with a solution 20 in which the additive is dissolved. The solution 20 filled in the storage container 100 is an aqueous solution in which a predetermined amount of EDTA, heparin, sodium citrate, sodium fluoride, etc. is dissolved in physiological saline, phosphate buffer, Good's buffer, or the like.

After the storage container 100 is sealed with an additive 21 or filled with a solution 20 in which the additive is melted, it is sealed with a container lid 200 and stored until blood collection. When using a storage container 100 filled with a solution 20 containing melted additives, immediately before blood collection, remove the container lid 200 from the storage container 100, attach the blood collection chip 400, and then tip it over to drain the entire solution 20 into the blood collection chip 400. After that, remove the blood collection tip and discard all the additive solution. As a result, a wet state is created in which a predetermined amount of the additive 21 remains on the inner wall 130 of the storage container and the flow path 430 of the blood collection chip.

According to the blood sampling device 1, the blood sampling opening 403 at the tip of the blood sampling tip 400 has a narrow tube with a diameter in the range of 0.5 mm to 1.2 mm, preferably around 0.8 mm, in the range of 30° to 45°, preferably. Preferably, the angle cut is around 40°.

According to the blood sampling device 1, the blood sampling chip 400 collects a blood sample using the tapered blood sampling portion 401 having a flow path 430 that connects the blood sampling opening 403 and the connecting opening 405H in the range of 6 mm to 12 mm, preferably around 8 mm. Can be collected. According to the blood sampling device 1, since the first groove part 406 is formed in the connection part 405 of the blood sampling chip 400, when the blood sampling opening 403 is brought into contact with the upper part of the stored sample to aspirate the sample, the first groove part 406 is formed. Air can be expelled from 406 and a blood sample can be aspirated through blood collection opening 403.

According to the blood sampling device 1, the first groove portion 406 provided in the connecting portion 405 of the blood sampling tip 400 releases the airtightness of the storage container 100, so after collecting the blood sample, the container can be placed vertically with the tip upward. By leaving it still, the blood sample sucked into the blood collection chip 400 can be moved to the storage container 100 side by its own weight. According to the blood sampling device 1, after storing blood in the storage container 100, the blood sampling chip 400 is removed from the blood storage container 10, and the included container lid 200 is set to seal the blood sampling space 102 of the storage container 100. Can be done.

According to the blood sampling device 1, after the blood storage container 10 is rotated several times to mix the additive with the blood, the blood storage container 10 can be directly set in a tester via the adapter 600, and then placed in a centrifuge. . At this time, the blood storage container 10 is centrifuged at 500G to 1500G, preferably around 1000G, for 2 to 5 minutes, preferably around 3 minutes. The adapter 600 includes a cylindrical portion 601 that fills the gap between the outer peripheral surface of the containment vessel 100 and the inner peripheral surface of the test tube 800, and a flange portion 602 that contacts and positions the upper end of the test tube 800. .

According to the blood collection device 1, plasma separated in the storage container 100 can be stored in the blood collection space 102 above the separation channel 10R, and blood cells can be stored in the closed container 300 at the bottom of the separation channel 10R. According to the blood sampling device 1, after separation, the stopper 250 is inserted into the separation channel 10R to block the storage container 100 and the closed container 300, and the plasma part and the blood cell part can be physically completely separated. .

According to the blood sampling device 1, if after centrifugation, plasma and blood cells cannot fit into their respective storage areas and a surplus portion is generated, the dial portion 350 is rotated, the plunger 360 is moved along the axis L direction, After adjusting the capacity of the storage space 302, recentrifugation is performed for a short period of about 20 to 30 seconds, and then the stopper 250 is inserted to block the plasma portion and the blood cell portion. If it is desired to take out the plasma immediately, the container lid 200 is removed from the blood storage container 10 and the plasma portion is dispensed. Since only the separated plasma is stored in the storage container 100, the required amount can be sucked up to the maximum amount without waste.

Further, a certain amount of diluent, for example, about 100 μl to 500 μl, preferably around 200 μl, of a special diluent is directly injected into the blood collection space 102 of the storage container 100 and mixed evenly with plasma to prepare a test sample. can do. In this case, the adapter 600 is set in the container after dilution and mixing, and the mixture is put into a test tube and subjected to the testing device as it is. Further, the blood cells separated and sealed in the airtight container 300 are dispensed directly from the airtight container 300 into a sample cup by removing the dial part 350 and the plunger 360, and are used as a test sample. As described above, the dial portion 350 is provided with two symmetrical slits 354, and by pinching the dial portion from the side, the width of the slits 354 is reduced and the fitting portion 351 is expanded, and the closed container 300 is closed. The dial part 350 is removed from the protrusion 304, and the plunger 360 can be pulled out from the storage space 302.

Normally, the user collects blood based on the blood sampling amount of 50 μl, 100 μl, or 200 μl marked on the measurement line 408 of the blood collection chip 400. A guideline for the required amount of blood to be collected is presented in advance based on a combination of measurement items. According to the blood sampling device 1, the user not only collects the amount of blood necessary for the measurement item, but also selects and changes test items as appropriate based on the amount of blood that can actually be collected into the blood sampling chip 400. It is also possible to do so, and the collected blood can be used without wasting it.

According to the blood sampling device 1, the user can perform reliable plasma separation by adjusting the position of the plunger 360 in advance by turning the dial part 350 according to the amount of blood to be collected, and adjusting the capacity of the storage space 302. Can be done.

Next, a procedure for blood sampling using the blood storage container 10 and the blood sampling device 1 using the same will be explained.

As shown in FIG. 5, the storage container 100 is used with a blood sampling tip 400 connected to its tip when collecting blood. When connected, the first groove 406 provided on the outer wall of the proximal end 410 releases the sealed state inside the container, making it possible to aspirate blood. In FIG. 5, reference numeral 2 indicates the surface of the fingertip viewed from the direction of the tip. Generally, the surface of a finger is a convex curved surface, but for convenience of explanation, it is expressed as a flat surface. When a fingertip is pricked with a needle or the like to cause blood to bleed, the bleeding blood B is pooled in the form of water droplets on the fingertip due to surface tension. With the upward mark 409 of the blood sampling chip 400 facing upward in this droplet-like blood B, the blood sampling opening 403 is brought into close contact with the upper surface of the stored blood from the side or from below the side without any gaps.

Then, wettability occurs in a part of the inner circumferential surface 430H of the flow path 430 exposed at the blood sampling opening 403, which causes a capillary phenomenon in the blood sampling opening 403 that is continuous with the inner circumferential surface 430H that is flush with and continuous with the inner wall of the tip. Work to your advantage. In this state, the balance between the surface tension of the droplet-shaped blood B and gravity is disrupted, and the blood flows from the fingertip 2 into the blood collection tip 400. In this state, the blood B on the surface of the fingertip 2 becomes the collected blood B1 taken into the flow path 430 of the blood collecting chip 400.

As shown in FIG. 6, after blood collection is completed, the blood collection device 1 is maintained vertically with the blood collection chip 400 and the storage container 100 connected. At this time, since an air passage is secured in the flow path 430 by the first groove portion 406, air can flow into the flow path 430. Thereby, the blood sample B1 falls naturally into the storage container 100 from within the flow path 430 of the blood sample chip 400 without being dispensed based on the action of its own weight.

As shown in FIG. 7, after the blood collection B1 is moved to the storage container 100, the blood collection chip 400 is extracted from the storage container 100. A container lid 200 is inserted into the first opening 101 of the storage container 100 . As shown in FIG. 7(a), the storage container 100 is sealed with a container lid 200. In the blood collection space 102 sealed by the container lid 200, the blood collection B1 is sealed and stored.

In this state, the sealed storage container 100 is repeatedly overturned, and the blood sample B1 and the pre-filled additive component 21 (see FIG. 3) are mixed. Thereby, the blood sample B1 is managed in an appropriate storage state.

As shown in FIG. 7(b), the blood sample B1 moved to the storage container 100 is then centrifuged. This centrifugation is preferably carried out at a relatively low rotation speed in the range of 500G to 1,500G, preferably at a centrifugal acceleration of around 1,000G. By performing centrifugation under these conditions, the gravitational load on the separation channel 10R of the storage vessel 100 and the storage space 302 is reduced, and stable separation can be performed.
After the separation, plasma B2 accumulates in the blood collection space 102, and blood cells B3 accumulate in the storage space 302. The storage state of the blood cells B3 separated and stored in the storage space 302 can be confirmed from the outside.

If blood cells B3 remain in the separation channel 10R, the position of the plunger 360 is adjusted by rotating the dial part 350, the capacity of the storage space 302 is increased, and recentrifugation is performed for a short time of about 20 to 30 seconds. The separation state is optimized by

As shown in FIG. 7(c), the stopper 250 is pushed in after centrifugation is completed. The stopper 250 closes off the separation channel 10R. The plasma part and the blood cell part can be physically separated between the storage container 100 and the closed container 300.

The blood storage container 10 rotates the plunger 360 along the axis L direction within a distance defined by the thread pitch based on the rotation of the threaded portion 361 provided on the plunger 360 and the threaded groove 353M of the dial portion 350. By moving the blood cells B3, the capacity of the storage space 302 that stores the blood cells B3 can be readjusted. Therefore, the user can efficiently prepare separated specimens of plasma and blood cells while checking the separation status of plasma and blood cells.

According to the blood storage container 10, since the dial portion 350 is provided, fine adjustment is possible by appropriately setting the pitch per rotation of the threaded portion 361 of the plunger 360 and the threaded groove 353M according to the desired accuracy. It becomes possible. According to the blood storage container 10, the volume can be finely adjusted in units of 2 to 3 μl per rotation, for example, one rotation or two rotations, which the user can easily operate. Note that instead of the threaded portion 361 and the threaded groove 353M of the plunger 360, if the amount of movement of the plunger 360 can be adjusted, other materials may be used, such as a minute uneven fitting portion that has a click feeling that can be sensed by the operator. A configuration may be provided.

According to the blood storage container 10, for example, if the blood cell ratio of the blood sample is higher than the initial setting value and some of the blood cells remain in the storage container 100 after centrifugation, the capacity of the closed container 300 is increased; On the other hand, if the amount of blood collected is insufficient and the amount of plasma is low, the effective volume of the storage space 302 can be adjusted to a smaller value by rotating the dial portion 350 and adjusting the position of the plunger 360. Thereafter, by centrifuging the blood storage container 10 again for a short time, separation of plasma and blood cells can be accurately completed.

According to the blood storage container 10, by using the volume adjustment function after centrifugation configured by the dial section 350, the plasma part in the collected blood can be separated to a volume close to the maximum volume. For example, the initial blood cell volume ratio is set small to about 35% for women and 40% for men, and the storage space 302 is finely adjusted to the correct size depending on the state of blood cell storage in the closed container 300 after centrifugation, and centrifugation is performed again. According to the blood storage container 10, it is possible to easily optimize the plasma and blood cell volumes, which differ for each individual blood sample, even when collecting blood from elderly people who are concerned about the relatively small amount of blood collected.

According to the blood storage container 10, the storage container 100 and the container lid 200 have an appropriate thickness to withstand external forces associated with storage, transportation, operation, and centrifugation, and have reliable airtightness. According to the blood storage container 10, the volume inside the storage container 100 when the container lid 200 is closed is small, ranging from 300 μl to 400 μl. According to the blood storage container 10, concentration changes due to environmental factors such as water evaporation during specimen storage can be minimized. Minimizing the risk of concentrating blood sample B1 during specimen transport is important for stable analysis of minute blood samples. Regarding the airtightness of the containment vessel 100, it is desirable to confirm whether or not the desired airtightness is secured by performing a pressure reduction test.

As shown in FIG. 8, when measuring a sample, the dial part 350 is first removed from the storage container 100 together with the plunger 360. Thereafter, the dispensing instrument V is inserted into the storage space 302, the blood cells B3 stored in the storage space 302 are dispensed, and items such as HbA1c (hemoglobin A1c value) are measured using the blood cells B3 as a sample.

As shown in FIG. 9, when measuring a specimen, 100 μl to 500 μl of plasma B2 separated and stored in the blood collection space 102, more preferably about 100 μl to 300 μl of diluent C, is directly dropped into the storage container 100. dilute and mix well. The dilution rate varies depending on the test items to be simultaneously measured, but is usually set to 30 times or less, more preferably 10 times or less.

By not dispensing a fixed amount of the plasma B2 separated in the storage container 100 into the sample cup, the entire plasma B2 can be used as a sample regardless of the plasma amount. This makes it possible to reduce the dilution factor of plasma B2 during sample measurement, making it possible not only to improve test accuracy but also to expand the number of items to be tested.

As shown in FIG. 9(b), the diluent C in the storage container 100 is a liquid in which a marker substance of a known concentration is evenly mixed with an aqueous solution such as Good's buffer, phosphate buffer, or physiological saline. used to dilute. The marker substance that dissolves in the diluent is not present in plasma B2, dissolves well in water, allows for highly sensitive absorbance measurement, and has high resistance to environmental conditions such as light, temperature, and humidity. It is a substance that As the marker substance, for example, choline chloride can be used.

As shown in FIG. 9(c), after uniformly mixing the non-quantitative diluted plasma B4 stored in the storage container 100, the storage container 100 is directly set in a biochemical testing device, and the suction needle 900 of the testing device is is inserted into the blood collection space 102 of the storage container 100 and the sample is taken out.
The absorbance of the diluted plasma B4 taken out is measured for the concentration of the diluted marker as one item of biochemical analysis.

In order to perform the above-mentioned measurements, the blood storage container 10 is desirably formed with a cylinder outer diameter of 10 mm to 12 mm to fit into a standard-sized test tube 800, and the flange portion 101F is supported at the edge of the adapter 600. It is desirable that the Further, it is desirable that a conical first tapered portion 103 be formed at the lowest part of the blood collection space 102 so that the maximum amount of plasma sample can be aspirated with the suction needle 900.

The dilution rate of an aqueous solution can generally be determined by dividing the marker content (absorbance) after mixing the target solution by the marker content (absorbance) of the original aqueous solution measured immediately before dilution. Since the sum of the dilution factors in mixed blood is always "1", the plasma dilution factor can be determined by subtracting the blood solution dilution factor from 1. Therefore, the plasma dilution factor can be calculated by dividing 1 by the plasma dilution factor. The value obtained by multiplying the measured value of each test item simultaneously measured using the same specimen by the plasma dilution factor determined by the above calculation becomes the test value of each test item. At this time, since the original absorbance measurement of the diluted marker is performed without any time difference from the marker absorbance measurement of the diluted sample, it is possible to eliminate the influence of environmental factors that cause errors when measuring the diluted marker, and the measured value, that is, the dilution ratio. Reliability can be guaranteed.

However, for items for which test values can be obtained using this method, the condition is that the calibration curve of the item expressed as absorbance versus concentration is linear. If a linear calibration curve cannot be obtained, this can be resolved by recreating the calibration curve using a diluted target area.

As shown in FIG. 10, the blood sampling device 1 can be used as a blood sampling device for immediate testing at the site in conjunction with a POCT (Point Of Care Testing) device. The test sample is either collected whole blood or centrifuged plasma. As shown in FIG. 10(a), when whole blood is used, the sample is discharged from the tip of the blood sampling tip 400 into a receiving tray specified by the testing device after blood sampling and mixing.

As shown in FIG. 10(b), when using separated plasma as a sample, the storage container 100 is centrifuged, the plasma and blood cells are separated by a stopper 250, and then the plasma is discharged into a receiving tray in the same way as for whole blood. can do. If a small amount of sample remains at the tip of the blood sampling tip 400, almost the entire amount can be discharged by touching the receiving tray at the tip of the blood sampling tip 400 and lightly tapping the blood sampling tip 400.

[Modified example]
Modifications of the present invention will be described below. In the following description, the same names and numerals will be used for the same configurations as in the above embodiment, and duplicate descriptions will be omitted as appropriate.

In this embodiment, an independent blood sampling device 1A can be configured using the configuration of the blood sampling chip 400 of the above embodiment.

As shown in FIGS. 11 and 12, the blood sampling device 1A includes a blood sampling tip 400X that collects blood, and a pusher 700 that is attached to the blood sampling tip 400X. The blood sampling chip 400X includes a blood sampling section 401 in which a blood sampling opening 403 is formed so that a part of the inner peripheral surface of the flow path is exposed on one side in the axial direction.

The blood collection chip 400X includes a blood collection part 401 that is formed so that the blood flowing into the flow path 430 when the blood serving as a sample comes into contact with a part of the inner circumferential surface 430H exposed in the blood collection opening 403; A cylinder portion 480 formed in a cylindrical shape is provided on the other side of the portion 401 in the axial direction. A pushing tool 700 is inserted into the internal space of the cylinder portion 480. An upward mark 489 having the same function as the upward mark 409 is formed on the outer peripheral surface of the cylinder portion 480 . At least one second groove portion 482 is formed in the cylinder inner peripheral surface 481 formed in the cylinder portion 480 along the axis L direction.

The second groove portion 482 is formed to have a predetermined length from one end of the cylinder inner circumferential surface 481 in the axial direction. For example, four second grooves 482 are formed in the cylinder inner circumferential surface 481, and constitute air vent passages when the pusher 700 is inserted during blood collection.

The pushing tool 700 includes a piston 701 inserted into the internal space of the cylinder portion 480 and an operating portion 702 formed continuously on one side of the piston 701 in the axial direction. The piston 701 is provided in the internal space of the cylinder portion 480 so as to be movable along the axis L direction. Piston 701 is formed into a cylindrical shape. The outer diameter of the piston 701 is formed to be slightly smaller than the inner diameter of the cylinder portion 480. A rod-shaped operating portion 702 is provided on the other axial side of the piston 701 .

With the above-described configuration, the blood sampling device 1A transfers the collected blood into the flow path 430 of the blood sampling section 401 through the blood sampling opening 403 by operating the operation section 702 and moving the piston 701 along the axial direction in the internal space. It can be discharged from The blood sampling device 1A can be used as a general-purpose plastic micro-blood sampling device that does not require hydrophilic treatment.

When collecting blood, the piston 701 is inserted to the front of the middle part of the cylinder part 480 where the second groove part 482 is formed, and the blood is aspirated using the same operating procedure as the blood sampling tip 400. In this state, the internal space of the cylinder portion 480 closed by the piston 701 communicates with the external space via the second groove portion 482. That is, the blood sampling device 1A can suck blood into the flow path 430 from the blood sampling opening 403 by capillary action instead of using the piston 701 to suck blood.

After sucking the blood, the piston 701 is pushed into the area beyond the middle part of the inner peripheral surface of the cylinder part 480 where the second groove part 482 is not formed by operating the operation part 702 to draw the blood stored in the blood collection chip 400. Dispense into a storage container, etc. In a region on one axial side of the cylinder inner circumferential surface 481 where the second groove portion 482 is not formed, the outer circumferential surface of the piston 701 and the cylinder inner circumferential surface 481 fit together without a gap.

After blood collection, the piston 701 is pushed into a region beyond the middle part of the cylinder inner circumferential surface 481, compressing the air inside the cylinder part 480 without leaking, and pushing out the blood from the blood collection tip part. Further, by applying an additive such as the above-mentioned anticoagulant to the cylinder inner circumferential surface 481 at the tip of the blood sampling tip 400X, the additive can be mixed with the blood during blood suction and discharge. By using the blood sampling device 1A shown in FIGS. 11 and 12, it is possible to efficiently conduct hematology tests, etc., in which whole blood is tested as a sample without centrifugation, and experiments on small animals such as mice. It is also highly convenient as a blood sampling tool.

According to the blood sampling device according to each of the embodiments described above or the embodiments modified without departing from the gist thereof, the plasma part of the collected blood can be used as a test sample without dispensing it without wasting a single drop. Can be done. According to the blood sampling device, the amount of blood required for testing can be halved compared to conventional blood sampling devices. For example, in a micro blood test for 13 biochemical items, a dilution test of about 10 to 15 times is generally performed, and at least 15 μl of plasma is required, so the amount of blood collected is 60 μl or more. Often requested.

By using the blood sampling device of the above embodiment, it is possible to collect the same amount of plasma as when collecting 60 μl of blood by collecting approximately 30 μl of blood with a standard hematocrit value, and the entire amount can be used as the test sample. It can be done.

In addition, according to the blood sampling device, the collected plasma can be directly diluted with a dilution solution containing a marker, and the dilution rate can be measured after the fact. There is no need to determine the amount of blood to be collected in advance, and it is sufficient to collect the minimum amount of blood each time depending on the combination of items to be tested, reducing the invasive burden on the user.

As described above, according to the blood sampling device, by cutting the tip of the plastic tube of the blood sampling tip at an angle, it is possible to automatically generate wettability on the inner wall of the tip when the liquid surface comes into close contact with the tip. When the tip hole of a plastic tube with an angle-cut tip is brought into close contact with the upper surface of the stored liquid without any gaps, a portion is created where the blood surface and the inner wall of the tube directly come into contact, and the liquid accumulates in this portion, creating a wet state. This causes a significant capillary phenomenon at the tip, making it possible to aspirate liquid from the tip into the container despite the plastic inner wall having a hydrophobic surface.

The plastic collection container has a tapered shape that expands downward, so the sucked liquid is pulled diagonally downward by gravity in addition to capillary action, and suction continues until the required amount is reached. As a result, there is no need to take measures such as hydrophilic treatment of the inner wall, which is required with conventional plastic blood sampling devices, and it is possible to reduce manufacturing man-hours and manufacturing costs.

During aspiration, the angle-cut tip of the blood sampling device is brought into contact with the upper part of the surface of the liquid, such as the pooled blood, so that the surface tension of the pooled liquid that is formed between the fingertip surface and the surface of the fingertip is not broken during contact, thus preventing the liquid from flowing down. does not induce Therefore, continuous suction of the stored liquid is possible without using tape to prevent dripping. In addition, the blood collected with the blood collection chip naturally falls into the storage container under its own weight through the air vent slit made in the fitting part of the blood collection chip and the container, so you can safely and reliably collect high-quality blood without any dispensing operations. The sample can be guided and stored in the storage container.

The collected blood is mixed with additives in a sealed storage container 100, and the blood cells are moved by centrifugation into a sealed container 300 partitioned by a separation channel 10R. Thereafter, the storage container and the closed container 300 are shut off by the stopper 250, and the physical separation of blood cells and plasma is completed. Separated plasma and blood cell samples are sealed and stored in the storage container 100 and airtight container 300, respectively, so they can be used as test samples even under various management conditions such as blood transportation, as long as standard storage requirements are met. Quality assurance can be obtained.

The blood cell storage capacity of the sealed container 300 can be freely changed by moving the plunger 360 along the axis L direction. By adjusting the position of the plunger 360 and changing the volume for storing blood cells during centrifugation, not only can the amount of collected plasma be maximized, but also the plasma portion and blood cell portion can be adjusted for blood samples with different blood collection volumes and hematocrit rates. It is possible to perform appropriate separation of plasma and maximize plasma volume. As a result, it becomes possible to reduce the blood collection volume for women and the elderly, who generally have low hematocrit rates, and to reduce the invasive burden.

The separated plasma is completely blocked from the blood cells or separation agent and has no contact at the separation surface, so the entire amount can be used as an analysis sample. Compared to a blood sampling device having a separate contact point, by sampling more plasma, the dilution rate of the analysis sample can be reduced and the concentration of components in the sample to be analyzed can be increased. As a result, we can expect not only a reduction in the amount of blood collected, but also an improvement in test accuracy and an expansion of the items to be tested.

When measuring a sample in a testing laboratory, after centrifugation, the plasma and blood cells are hermetically sealed in the container, and the diluent is dropped directly into the storage container, allowing the separated plasma to be collected without dispensing plasma. are mixed and diluted in the storage container 100, and using the adapter 600, the container is set in a testing test tube and applied to testing equipment. In addition, the stem of the sealed container is removed, and the blood cells stored in the sealed container are taken out, dispensed, and tested. This not only improves the efficiency of inspection work, but also eliminates manual weighing work and improves inspection accuracy.

Although the embodiment of the present invention has been described above in detail with reference to the drawings, the specific configuration is not limited to this embodiment, and design changes and the like may be made without departing from the gist of the present invention.

1, 1A Blood collection device 10 Blood storage container 10R Separation channel 100 Storage container 101 First opening 101F Flange section 102 Blood collection space 103 First tapered section 130 Storage container inner wall 140 Opening section 160 Cylinder section 200 Container lid 210 Bottom section 220 Flange section 250 Stopper 251 Pressing part 252 Slide part 300 Airtight container 301 Second opening 302 Storage space 303 Second tapered part 304 Projection part 305 Outer peripheral surface 350 Dial part 351 Fitting part 352 Inner peripheral surface 353 Through hole 353M Thread groove 354 Slit 360 Plunger 361 Screw part 362

Head

400, 400X Blood collection chip 401 Blood collection part 403 Blood collection opening 405 Connection part 405H Connection opening 406 First groove part 408 Measuring line 409 Upward mark 430 Flow path 430H Inner peripheral surface 480 Cylinder part 481 Inner circumference of cylinder Surface 482 Second groove 500 Cap 600 Adapter 700 Pusher 701 Piston 702 Operating section 800 Test tube 900 Suction needle

Claims

A blood storage container for storing and preserving blood,
a storage container having a first opening on one side in the axial direction and forming a blood collection space for storing the blood;
a closed container provided on the other axial side of the storage container, having a second opening on the other axial side and forming a storage space for storing the blood;
a dial portion rotatably provided on the other axial side of the closed container so as to cover the second opening,
A separation flow path that is continuous with the blood collection space and the storage space is formed between the blood collection space and the storage space,
The blood collection space is formed so as to be continuous with the separation flow path on the other side in the axial direction,
The separation flow path is formed to have a smaller cross section than the blood collection space,
The storage space has a larger cross section than the separation channel,
The dial portion is formed to protrude toward the other side in the axial direction, and has a plunger that is movable in the axial direction while in contact with the inner surface of the storage space.
Blood storage container.
The dial portion includes a fitting portion that fits into the airtight container, and two slits formed symmetrically along the axial direction so as to cut out an outer circumferential surface and an inner circumferential surface,
The width of the slit is reduced by pressing the outer peripheral surface,
The fitting part deforms as the slit width decreases, and the fitting part with the closed container is released,
The dial portion is removed from the sealed container together with the plunger when the fitting between the fitting portion and the sealed container is released.
The blood storage container according to claim 1.
The separation flow path is provided with a stopper that connects or blocks the blood collection space and the storage space,
The stopper is provided so as to be movable in a direction intersecting the axial direction of the separation flow path and the storage space.
The blood storage container according to claim 2.
A blood storage container according to any one of claims 1 or 2,
a blood collection chip that is removably attached to the blood storage container so as to close the first opening on one axial side of the storage container,
The blood collection chip includes a blood collection part in which a blood collection opening is formed so that a part of the inner circumferential surface of the flow path is exposed on one side in the axial direction,
The blood sampling section is formed such that blood serving as a sample comes into contact with a part of the inner circumferential surface exposed in the blood sampling opening, so that the blood flows into the flow path.
Blood sampling equipment.
The blood sampling opening is formed in a shape cut at an angle with respect to the axial direction.
The blood sampling device according to claim 4.
The blood collection chip includes a connection portion inserted from the first opening on the other axial side,
At least one first groove portion is formed along the axial direction on the outer peripheral surface of the connecting portion.
The blood sampling device according to claim 5.
A blood collection chip is provided with a blood collection opening formed so that a part of the inner circumferential surface of the flow path is exposed on one side in the axial direction,
The blood sampling chip includes a blood sampling section formed in such a way that blood serving as a sample comes into contact with a part of the inner circumferential surface exposed in the blood sampling opening so that the blood flows into the flow path;
a cylinder portion formed in a cylindrical shape and provided on the other axial side of the blood collection chip;
a pushing tool inserted into the internal space of the cylinder part,
The extrusion tool is
A piston inserted into the internal space and provided movably along the axial direction; and an operating section formed continuously on one side of the piston in the axial direction,
Discharging the blood collected into the flow path from the blood collection opening by operating the operation portion and moving the piston along the axial direction within the internal space;
Blood sampling equipment.
At least one second groove is formed along the axial direction on the inner peripheral surface of the cylinder formed in the cylinder part,
The second groove portion is formed to have a predetermined length from one end in the axial direction of the inner circumferential surface of the cylinder.
The blood sampling device according to claim 7.