JP3890067B2 - Sample collection container - Google Patents

Description

  The present invention relates to a specimen collection container used for separating plasma or serum from blood and examining components in the plasma or serum, and more particularly, separating and collecting plasma or serum from blood in a short time. The present invention relates to a specimen collection container in which leakage of components in erythrocytes is prevented and contamination of the components in erythrocytes into plasma or serum is prevented.

  Conventionally, centrifugation has been used to remove blood cell components from blood and obtain plasma or serum necessary for clinical examination. However, in the centrifugal separation method, operations such as the coagulation process and the process of transferring the supernatant plasma or serum after the separation are complicated. Moreover, it took time to obtain the test result, and a large and expensive centrifuge was required.

  In order to solve this problem, various instruments have been proposed that can remove blood cell components from blood and obtain plasma or serum necessary for clinical examination without using a centrifuge.

  Patent Document 1 below shows an example of a blood test container that enables plasma or serum to be separated from collected blood and that the separated plasma or serum can be taken out. With reference to FIG. 8, the blood test container shown in Patent Document 1 will be described.

  As shown in a longitudinal sectional view in FIG. 8, the blood test container 101 is an airtight container having an outer tube 102, a cylindrical member 103, and a plug 104, and the inside is decompressed. A cylindrical member 103 is inserted into the outer tube 102. The outer tube 102 is a bottomed tubular container, and the outer tube 102 has an opening 102a at the upper end.

  On the other hand, the cylindrical member 103 has an opening 103a at its upper end. A filter 105 is accommodated in the lower part of the cylindrical member 103. The filter 105 includes a filter member 106 and a blood cell stop film 107 disposed below the filter member 106. The filter member 106 is made of a filter material that moves plasma or serum faster than blood cell components. The blood cell stop membrane 107 captures blood cells and prevents the blood cells from being mixed into the separated plasma or serum.

  A protruding portion 103 b protruding downward is formed at the lower end of the cylindrical member 103. A plasma or serum channel 108 is provided in the protrusion 103b. The plasma or serum channel 108 is provided so as to face the lower surface of the blood cell stop film 107 and to extend downward in the protrusion 103b. The plasma or serum separated by the filter member 106 flows down from the plasma or serum channel 108 to the lower plasma or serum storage unit 109. The space above the filter member 105 constitutes the blood storage part 110.

  The plug 104 includes a grip portion 104a, a large diameter portion 104b, and a small diameter portion 104c. The large diameter portion 104b has a larger diameter than the small diameter portion 104c. The small diameter portion 104 c is press-fitted into the opening 103 a of the cylindrical member 103, and the large diameter portion 104 b is press-fitted into the opening 102 a of the outer tube 102.

  When the blood test container 101 is used, blood is collected in the blood storage unit 110 by a pressure difference between the inside and outside by inserting a blood collection needle through the plug 104. The collected blood is filtered by the filter 105. As described above, in the filter member 106, plasma or serum moves downward faster than the blood cell component. Then, plasma or serum passes through the blood cell stop membrane 107 and reaches the plasma or serum channel 108. Thereafter, the plasma or serum flows down to the plasma or serum storage unit 109. On the other hand, blood cells are captured by the blood cell stop film 107. When the blood cell stop film 107 is blocked by blood cells, the filtration is stopped.

After the plasma or serum is separated, the stopper 104 that is press-fitted into the opening 102a of the outer tube 102 can be removed together with the tubular member 103, and the separated plasma or serum can be taken out.
JP 2004-325412 A

  In the blood test container 101 described in Patent Document 1, as described above, blood is collected in the blood storage unit 110 by a pressure difference between the inside and outside by inserting a blood collection needle through the plug 104.

  However, in Patent Document 1, when blood is allowed to flow in, if the degree of decompression in the blood test container 101 is high, blood may flow from the tip of the blood collection needle at a high speed. When blood flows in at high speed, blood cells may collide with the filter member 106 at high speed, and the blood cells may be destroyed. When blood cells are destroyed and components in red blood cells leak, the components in red blood cells are mixed into plasma or serum stored in plasma or serum storage unit 209. In this case, when the obtained plasma or serum was examined, the mixed erythrocyte component greatly affected the test result, and a highly reliable test result could not be obtained.

  In order to prevent the blood cells from being destroyed, it is necessary to reduce the degree of decompression of the blood test container 101. However, if the degree of vacuum is too low, filtration may stop during blood separation, and the required amount of plasma or serum may not be obtained.

  In view of the state of the prior art described above, the object of the present invention is to separate and collect plasma or serum from blood in a short time and to prevent leakage of erythrocyte components. An object of the present invention is to provide a specimen collection container in which contamination into serum is prevented.

  The present invention is a sample collection container used for separating plasma or serum from blood and examining components in the plasma or serum, having a first opening on one end side and a second opening on the other end side. A cylindrical container body having two openings, a first stopper attached to the first opening of the container body, a second stopper attached to the second opening of the container body, A blood separation material for separating blood into blood cells and plasma or serum, and the container body is disposed on the second opening side. The first plug body has an internal space in which plasma or serum separated from blood is accommodated, and blood introduced from the first opening of the container body is brought into contact with the blood separation material before contact. Between blood and blood separating material and separating blood while diffusing blood in multiple directions And further comprising a blood diffusion material to flow into.

  In a specific aspect of the sample collection container according to the present invention, the sample collection container further includes a blood cell stop membrane that is disposed between the blood separation material and the internal space and prevents passage of blood cells separated by the blood separation material. .

  In another specific aspect of the sample collection container of the present invention, the sample collection container is disposed between the blood separation material and the internal space, and swells when contacted with plasma or serum separated by the blood separation material, and the flow path A flow path closing member is further provided.

  In still another specific aspect of the specimen collection container of the present invention, the flow path blocking member is disposed between the blood cell stop film and the internal space.

  In still another specific aspect of the specimen collection container according to the present invention, the outer surface of the second stopper is covered with a cover that prevents the second stopper from being pierced by a blood collection needle or a syringe. Yes.

  In another specific aspect of the specimen collection container according to the present invention, the inner peripheral surface of the cylindrical container body is tapered toward the first opening side of the container body.

  In still another specific aspect of the sample collection container according to the present invention, the first and second stoppers are hermetically attached to the first and second openings of the container body, and the inside of the container body is decompressed. Has been.

  The sample collection container of the present invention has a cylindrical container body having a first opening on one end side and a second opening on the other end side, and a first attached to the first opening of the container body. And a second plug attached to the second opening of the container body. The container body is disposed on the second opening side and has an internal space in which plasma or serum separated from blood is accommodated. In the present invention, since the blood separation material is provided on the first opening side of the container main body and for separating blood into blood cells and plasma or serum, the blood is separated during blood separation. The separation material can be used to separate blood into blood cells and plasma or serum by using a difference in moving speed between blood cells and plasma or serum. The separated plasma or serum can be stored in the internal space.

  In the present invention, the blood introduced from the first opening of the container body is disposed between the first stopper and the blood separating material so that the blood comes into contact with the blood separating material, and the blood The blood diffusion material is further provided to flow the blood into the blood separation material while diffusing blood in multiple directions, so that the blood is diffused in multiple directions within the blood diffusion material, and the blood reaches the blood separation material. That is, in the sample collection container of the present invention, when blood is collected, blood cells are prevented from directly colliding with the blood separation material, and the blood is diffused in multiple directions and flows into the blood separation material. Therefore, it is possible to obtain plasma or serum that is hard to destroy blood cells and is not contaminated with components in red blood cells.

  In the case of further comprising a blood cell stopping membrane disposed between the blood separating material and the internal space and preventing passage of blood cells separated by the blood separating material, the blood cells are separated by the blood cell stopping membrane during blood separation. Can be reliably prevented, and contamination of red blood cells and white blood cells into plasma or serum can be more reliably prevented.

  In the case of further comprising a flow path closing member that is disposed between the blood separation material and the internal space, swells by being contacted with plasma or serum separated by the blood separation material, and closes the flow path, After the separated plasma or serum is accommodated in the internal space, the flow path is closed by swelling of the flow path closing member due to contact with plasma or serum.

  Therefore, when blood cells reach the flow path closing member later than plasma or serum due to the difference in moving speed, the flow path is closed, so blood cells are mixed into the plasma or serum stored in the internal space. Can be prevented. Furthermore, even when the blood components are left for a long time after separating the blood and the components in the red blood cells leak, the flow path is blocked, so that the components of the red blood cells can be prevented from being mixed into the plasma or serum.

  When the plasma or serum contained in the internal space is taken out after separating the blood, after arranging the sample collection container so that the first opening is on the lower side and the second opening is on the upper side, What is necessary is just to extract a 2nd stopper from a 2nd opening. In the present invention, since the flow path is closed by the flow path closing member, the plasma or serum stored in the internal space does not reach the blood separation material. Therefore, since plasma or serum is difficult to come into contact with blood cells or erythrocyte components, contamination of plasma or serum can be prevented. Therefore, uncontaminated plasma or serum can be easily and reliably removed from the second opening. In addition, it is possible to reliably prevent a laboratory technician from being infected with a pathogen in the blood by contacting the separated plasma or serum.

  When the flow path blocking member is disposed between the blood cell stop film and the internal space, the flow path between the blood cell stop film and the internal space is blocked, so that the plasma contained in the internal space or When removing the serum, even if the sample collection container is arranged so that the first opening is on the lower side and the second opening is on the upper side, plasma or serum does not reach the blood cell stop membrane. Therefore, it is possible to more reliably prevent the red blood cells and white blood cells trapped in the blood cell stop membrane from being mixed into the plasma or serum.

  If the outer surface of the second plug is covered with a cover that prevents the second plug from being pierced by the blood collection needle or syringe, the blood collection needle or The syringe can be pierced and blood can be prevented from being collected in the internal space.

  When the inner peripheral surface of the cylindrical container body is tapered toward the first opening side of the container body, the amount of plasma or serum contained in the internal space is small. Since the liquid level becomes higher and the liquid level becomes closer to the second opening, it becomes possible to take out plasma or serum more easily.

  When the first and second stoppers are airtightly attached to the first and second openings of the container body, and the inside of the container body is depressurized, blood is sucked into the sample collection container by vacuum suction Since blood filtration proceeds rapidly, blood can be separated into blood cells and plasma or serum in a shorter time.

  Hereinafter, the present invention will be clarified by describing specific embodiments of the present invention.

  1 (a) and 1 (b) show a sample collection container according to the first embodiment of the present invention in a front view and a front sectional view.

  As shown in FIGS. 1 (a) and 1 (b), the sample collection container 1 has a cylindrical container body 2 having a first opening 2a on one end side and a second opening 2b on the other end side. Have. The other end side of the container body 2 has a shape tapered to an inverted frustoconical shape, and the opening diameter of the first opening 2a is smaller than the opening diameter of the second opening 2b. On the inner peripheral surface of the center of the container body 2, an annular protrusion 2c is provided. The annular protrusion 2c forms an opening 2d surrounded by the annular protrusion 2c, and constitutes a hollow flow path. The annular protrusion 2c on the inner peripheral surface of the container body 2 is tapered 2e toward the first opening 2c.

  1A and 1B, the sample collection container 1 is illustrated so that the first opening 2a is on the lower side and the second opening 2b is on the upper side.

  The container body is not limited to a cylindrical shape, and may have a shape such as a rectangular tube. The material of the container body is not particularly limited as long as it has air impermeability. Examples of the material of the container body include a resin made of acrylonitrile / butadiene / styrene (ABS), polyethylene terephthalate (PET), polycarbonate, polystyrene, polypropylene (PP), polyethylene (PE), nylon, acrylic, or the like. When the container body is made of a synthetic resin, the air non-permeation performance may be improved by depositing metal, silicon, or the like on the surface.

  A first stopper 3 is attached to the first opening 2 a of the container body 2 so as to hermetically seal the inside. The first plug 3 has a large diameter portion 3a and a small diameter portion 3b. The large diameter portion 3a has a larger diameter than the small diameter portion 3b. A circular recess 3c is formed in the center of the outer surface of the first stopper so as to be fitted with a blood collection needle or a distal end portion of a syringe, which will be described later, and to facilitate piercing with the blood collection needle or syringe. Is provided. The small diameter portion 3b is press-fitted into the first opening 2a, and the first opening 2a is hermetically sealed by the first plug body 3.

  The first stopper is preferably made of a material that is impermeable to air and can be pierced by a blood collection needle or syringe. Examples of the material constituting the first plug body include elastic bodies such as natural rubber, butyl rubber, isoprene rubber, and thermoplastic elastomer.

  On the other hand, a second stopper 4 is detachably attached to the second opening 2b of the container body 2. The second plug 4 has a large diameter part 4a and a small diameter part 4b. The large diameter portion 4a has a larger diameter than the small diameter portion 4b. The large diameter portion 4 a has a diameter larger than the outer diameter of the container body 2. The small diameter portion 4b is press-fitted into the second opening 2b, and the second opening 2b is hermetically sealed by the second plug body 4.

  It is preferable that the 2nd plug body is comprised with the raw material which does not have air permeability. Examples of the material constituting the second plug body include elastic bodies such as natural rubber, butyl rubber, isoprene rubber, or thermoplastic elastomer.

  In order to prevent the second plug body 4 from being pierced by a blood collection needle or a syringe, the outer surface of the second plug body 4 is covered with a cover 5. In the present embodiment, the entire outer surface of the large diameter portion 4 a is covered with the cover 5. The cover 5 extends further downward from the outer peripheral side surface of the large diameter portion 4a, and the lower end 5a of the cover 5 reaches the outer peripheral side surface of the second opening 2b. An annular projection 5 b is formed on the inner peripheral side surface of the cover 5. The inner diameter of the cover 5 is equal to or slightly smaller than the outer diameter of the large diameter portion 4a, but the inner diameter of the annular protrusion 5b is equal to or slightly smaller than the outer diameter of the small diameter portion 4b. That is, the front end surface 5c of the annular protrusion 5b is in contact with the outer peripheral side surface of the small diameter portion 4b, and the side surface 5d of the annular protrusion 5b is in contact with the step portion 4c between the large diameter portion 4a and the small diameter portion 4b. ing. Further, a plurality of steps 5e are formed on the outer peripheral side surface of the cover 5 so that the cover 5 can be easily removed together with the second plug 4 so that it can be easily grasped.

  It is preferable that the outer surface of the second plug is covered with a cover made of, for example, metal, synthetic resin, or the like. When a cover that is not pierced by the blood collection needle or syringe is provided, the blood collection needle or syringe is accidentally pierced by the second stopper and blood is prevented from being collected in the second internal space. be able to. Although it does not specifically limit as a material which comprises a cover, For example, a polypropylene, polyethylene, a polyethylene terephthalate, a polycarbonate etc. are mentioned.

Since blood is filtered by the pressure difference between the inside of the syringe and the internal space of the sample collection container, when the internal space is at atmospheric pressure, the pressure inside the syringe is reduced to atmospheric pressure by pressing the piston of the syringe. That is all. In this case, it is necessary to keep pressing the piston until the filtration is completed.

  Prior to use, it is preferable that the first and second stoppers 3 and 4 are hermetically attached to the first and second openings 2a and 2b, and the inside of the sample collection container 1 is decompressed. When the inside of the sample collection container 1 is depressurized, blood can be efficiently filtered while vacuuming as will be described later.

  The degree of reduced pressure in the sample collection container is not particularly limited, but is preferably in the range of 2 to 90 kPa, and more preferably in the range of 20 to 60 kPa. If the degree of decompression is too low, blood may not be separated efficiently, and if the degree of decompression is too high, pressure may be applied to red blood cells, causing hemolysis.

  As shown in FIG. 1B, the container body 2 has an internal space A1 in which plasma or serum separated from blood is accommodated on the second opening 2b side. The internal space A1 is located closer to the second opening 2b than the annular protrusion 2c.

  The sample collection container 1 includes a blood separating material 6 for separating blood into blood cells and plasma or serum on the first opening 2a side. The blood separating material 6 has the property of moving plasma or serum faster than blood cells. Examples of the blood separation material include a collection of ultrafine fibers, a foam or sintered body having continuous bubbles, a hollow fiber membrane, a porous membrane, porous particles, a film having a plurality of grooves and / or pores, and the like. However, the present invention is not limited to the above examples as long as blood can be substantially separated into blood cells and plasma or serum. Further, the blood cell component may be separated by being captured inside the filter, or may be separated by a difference in moving speed between the blood cell component and the plasma or serum component.

  The material constituting the blood separating material is not particularly limited, and examples thereof include polyethylene, polypropylene, polyethylene terephthalate, polybutylene terephthalate, polystyrene, polyvinyl acetate, urethane, acrylic, rayon, and glass.

  The blood separating material may have a property of adsorbing blood components. In this case, the blood separation material may be subjected to a surface treatment. Although it does not specifically limit as a surface treating agent, Hydrophobic polymers, such as polyether type | system | group, a silicon type, hydrophilic polymers, such as polyvinyl alcohol or polyvinylpyrrolidone, Furthermore, natural hydrophilic polymers, polymeric surfactant Etc. Further, the surface of the blood separating material may be subjected to a hydrophilic treatment by chemical treatment with an oxidizing agent, plasma treatment, or the like.

  The blood separation material can be divided into an asymmetric filter and a symmetric filter. Here, the asymmetric filter is a general term for a filter having a structure in which the pore diameter decreases from the blood inflow side to the outflow side. Other blood separation materials are collectively referred to as a symmetric filter.

  Among these blood separation materials, as a symmetric filter, the average pore diameter is preferably in the range of 1 μm or more and 10 μm or less. More preferably, it is the range of 2 micrometers or more and 8 micrometers or less. This is because if the average pore size is smaller than 1 μm, red blood cells may be hemolyzed, and if it is larger than 10 μm, separation between blood cells and plasma or serum will be remarkably deteriorated.

  Moreover, it is preferable that an average pore diameter is 0.01 micrometer or more and 10 micrometers or less as an asymmetric filter among blood separation materials. More preferably, it is 0.1 μm or more and 6 μm or less. If the average pore size is less than 0.01 μm, blood cell components may become clogged and may not be separated or hemolysis may occur. If the average pore size is greater than 10 μm, separation of blood cells from plasma or serum will be extremely poor. is there.

  When the blood separation material is composed of an aggregate of ultrafine fibers, it is preferable that fiber bodies having an average fiber diameter in the range of 0.5 to 3.0 μm are accumulated. When the average fiber diameter is smaller than 0.5 μm, hemolysis is likely to occur when blood is separated. When the average fiber diameter is larger than 3.0 μm, it is necessary to form a blood separation material at a high density in order to separate blood cells from plasma or serum, and the amount of fibers used increases and the cost increases. In order to further enhance the blood separation effect, the average fiber diameter is more preferably in the range of 0.5 to 2.5 μm.

The average density of the blood separation material when installed in the container body is preferably in the range of 0.1 to 0.5 g / cm ³ . When the average density is lower than 0.1 g / cm ³ , blood separation may not be performed effectively, and the amount of plasma or serum obtained may be reduced. When the average density is higher than 0.5 g / cm ³ , the load on erythrocytes becomes large and hemolysis is likely to occur. In order to separate blood more efficiently, the average density is preferably in the range of 0.15 to 0.40 g / cm ³ .

  It is also possible to use a combination of the symmetric filter and the asymmetric filter as the blood separating material.

  The blood separating material may have a property of adsorbing blood components. In this case, the blood separation material may be subjected to a surface treatment in order to suppress or control the adsorption of components in the blood. The surface treatment agent is not particularly limited, but is a polyether-based or silicone-based lubricant, a hydrophilic polymer such as polyvinyl alcohol or polyvinylpyrrolidone, a natural hydrophilic polymer, or a polymer surfactant. Etc. Further, the surface of the blood separating material may be subjected to a hydrophilic treatment by chemical treatment with an oxidizing agent, plasma treatment or the like. Conversely, water repellent treatment may be performed using hydrophobic silicone or a fluorine-based surface treatment agent.

  In the present invention, the specimen collection container 1 includes a blood diffusion material 7 that allows blood to flow into the blood separation material 6 while diffusing blood in multiple directions. The blood diffusing material 7 is disposed between the first stopper 3 and the blood separating material 6 so that the blood introduced from the first opening 2 a is brought into contact with the blood separating material 6 before the blood is introduced. . The blood diffusing material 7 is disposed so as to contact the blood separating material 6.

  The material constituting the blood diffusion material is not particularly limited, and examples thereof include polyethylene, polypropylene, polyethylene terephthalate, polybutylene terephthalate, polystyrene, polyvinyl acetate, urethane, acrylic, rayon, and glass.

  The blood diffusion material preferably has a plurality of holes in order to diffuse blood in multiple directions. The pore diameter of the blood diffusing material is preferably in the range of 15 to 2000 μm, and more preferably in the range of 20 to 1000 μm. When the pore diameter is in the range of 15 to 2000 μm, blood diffuses more effectively in multiple directions in the blood diffusion material 6.

  The porosity of the blood diffusion material formed by a plurality of pores is preferably in the range of 50 to 97%, more preferably in the range of 60 to 95%. When the porosity is in the range of 50 to 97%, blood diffuses more effectively in multiple directions in the blood diffusion material 6.

  The sample collection container 1 includes a disk-shaped flow path blocking member 8 made of a resin that swells when it comes into contact with plasma or serum separated by a blood separation material 6. The flow path closing member 8 is disposed between the blood separating material 6 and the internal space A1. The flow path closing member 8 is disposed so as to contact the annular protrusion 2c.

  In the initial state, that is, before swelling, a hole 8a is formed in the center of the channel closing member 8 so as to secure a channel through which plasma or serum flows. The hole 8a is connected to the opening 2d. Note that the flow path blocking member 8 may be disposed between a blood cell stop membrane and a blood separation material 6 described later.

  Examples of the material constituting the flow path blocking member include a resin having a hydrophilic functional group in the molecular skeleton and capable of absorbing the same amount or more of water relative to its own weight. Specific examples of the material constituting the flow path blocking member include polyacrylic acid alkali metal salt resins or copolymers thereof and their crosslinked products, polyacrylamide resins or copolymers thereof and their crosslinked products, poly N -Vinylacetamide resin or a copolymer thereof and a crosslinked product thereof, a silicon resin or a copolymer thereof and a crosslinked product thereof, a polyvinyl ether resin and a copolymer thereof and a crosslinked product thereof, a polyalkylene oxide resin or Examples thereof include copolymers and cross-linked products thereof, polyvinyl alcohol, polyvinyl pyrrolidone or copolymers thereof and cross-linked products thereof.

  As the flow path blocking member, a powdered or granular material may be used, or a film or sheet shaped material may be used, and it may be added and dried as a paste, slurry or solution. May be.

  The channel closing member swells itself when it comes into contact with plasma or serum, and blocks the channel. Therefore, the required amount of the flow path closing member varies depending on the flow path volume to be closed, the swelling rate and the swelling speed of the flow path closing member. Therefore, the optimum amount of the channel closing member is calculated from the channel volume to be closed, the swelling rate and the swelling speed of the channel closing member.

  The channel volume to be closed is set in a range where moisture in the blood is absorbed and the collected amount of the sample does not decrease. When the volume of the flow path is increased, the amount of the flow path blocking member for blocking is increased, so that the amount of collected sample may be reduced.

Therefore, the closed channel volume is preferably in the range of 0.005 to 1.0 cm ³ . The volume of the channel closing member is preferably in the range of 5 to 95% with respect to the channel volume to be closed. If the volume of the flow path blocking member is less than 5% of the flow path volume to be blocked, the time until the flow path is closed becomes longer, so components that have leaked from red blood cells due to hemolysis are mixed into the separated plasma or serum. There is a risk. If the volume of the flow path closing member is larger than 95% of the volume of the flow path to be closed, the flow path may be closed before all the plasma or serum is collected, and the efficiency of collecting plasma or serum is reduced. There is a fear.

  The sample collection container 1 includes a disk-shaped blood cell stop film 9 in which a large number of holes 9 a that prevent passage of blood cells separated by the blood separating material 6 are formed. The blood cell stop membrane 9 is disposed between the blood separating material 6 and the flow path closing member 8. The blood cell stop membrane 9 is in contact with the blood separating material 6 and is spaced apart from the flow path closing member 8 by a certain distance.

  The blood cell stop membrane is composed of a membrane in which a large number of pores are formed so that blood cells cannot pass through but plasma or serum can pass through. However, the blood cell stop membrane may be a filter member other than the membrane.

  The blood cell stop membrane is not particularly limited as long as it has a property of preventing passage of red blood cells. Examples of materials having such properties include polyvinylidene difluoride, polytetrafluoroethylene, cellulose acetate, nitrocellulose, polycarbonate, polyethylene terephthalate, polyethylene, polypropylene, glass fiber, borosilicate, vinyl chloride, silver, and the like. Can be mentioned.

  When the blood cell stopping membrane is composed of a porous substance, plasma or serum can pass through. The porous substance constituting the blood cell stopping membrane is not particularly limited as long as it has a pore size within a range that can prevent passage of red blood cells. In order to prevent passage of red blood cells, the pore diameter is preferably 1 μm or less. If the pore size is small, clogging may occur due to protein components in the blood. Therefore, the pore size is preferably 0.01 μm or more. In order to more effectively prevent the passage of red blood cells, the pore diameter is more preferably in the range of 0.05 μm or more and 1 μm or less.

  In order to increase the flow rate of filtration, the surface of the blood cell stop membrane may be subjected to a hydrophilic treatment. Examples of the hydrophilic treatment method include plasma treatment and coating with a hydrophilic polymer, but are not limited to these methods, and other methods may be used.

  A method of using the sample collection container 1 according to this embodiment described above will be described below with reference to FIGS. In FIGS. 2 to 5, the process of separating blood into blood cells and plasma or serum and further taking out the separated plasma or serum is shown step by step.

  2 shows a state before the syringe from which blood is collected is inserted into the sample collection container 1, and FIG. 3 shows a state in which blood is flowing into the sample collection container 1 from the syringe from which blood has been collected. Each state is shown in front sectional view. FIG. 4 shows a state after the separated plasma or serum is accommodated in the internal space, and FIG. 5 shows a state when the separated plasma or serum is taken out from the sample collection container 1 in a front sectional view. 2 to 4 show the sample collection container 1 in a state where the state shown in FIG. 1 is turned upside down.

  As shown in FIG. 2, when separating blood, the specimen collection container 1 is arranged so that the first opening 2a is on the upper side and the second opening 2b is on the lower side.

  First, for example, blood is collected in the syringe 11. On the needle tip 12a side of the hollow needle 12 of the syringe 11, a hub 13 that can be airtightly fitted with the concave portion 3c of the first plug 3 described above is provided. The insertion distance of the hollow needle 12 into the first plug body 3 is regulated by the hub 13. That is, the syringe 11 is configured so that the needle tip 12a can be inserted into the blood diffusion material 7 so that the needle tip 12a does not reach the blood separating material 6 when inserted into the first plug body 3. Has been.

  Next, as shown in FIG. 3, the hollow needle 12 is pierced through the first stopper 3 while the hub 13 is fitted in the recess 3 c, and the needle tip 12 a is brought into the blood diffusion material 7. Thereafter, blood flows into the blood diffusing material 7. The blood flowing in from the first opening 2 a comes into contact with the blood diffusion material 7 before the blood separation material 6.

  In this embodiment, since the inside of the sample collection container 1 is depressurized, blood is quickly sucked into the sample collection container 1 due to a pressure difference between the inside of the sample collection container 1 and the syringe 11. That is, the piston of the syringe 11 moves as blood flows in, the atmospheric pressure in the syringe 11 is maintained, and blood quickly flows into the sample collection container 1 according to the degree of pressure reduction in the sample collection container 1.

  As shown in FIG. 3, the blood is preferably flowed into the blood diffusion material 7. When blood flows directly into the blood diffusing material 7, it is possible to prevent blood cells from colliding with the blood diffusing material 7 at a high speed when the blood flows in and destroying the blood cells. The blood that has flowed into the blood diffusion material 7 diffuses in multiple directions within the blood diffusion material 7. Therefore, the blood diffused in multiple directions in the blood diffusion material 7 flows into the entire surface 6a of the blood separation material 6 on the first opening 2a side.

  When blood is collected, vacuum blood collection may be performed using a holder, or the blood collection needle may be inserted into the first stopper 3 after blood is once collected from the blood collection needle. After collecting blood, the syringe 11 may remain inserted in the first plug 3 or may be removed from the first plug 3.

  The blood that has reached the blood separating material 6 passes through the blood separating material 6. In the blood separating material 6, when blood passes, plasma or serum moves faster than blood cells. In this embodiment, since blood flows into the entire surface 6a on the first opening 2a side of the blood separating material 6, the blood separation efficiency is enhanced.

  Plasma or serum that has moved relatively fast reaches the blood cell stop membrane 9 first and passes through the hole 9a of the blood cell stop membrane 9. Then, plasma or serum passes through the hole 8a of the flow path closing member 8, flows down from the hollow flow path of the opening 2d of the container body 2, and is stored in the internal space A1.

  Even if the blood cells moved at a lower speed than plasma or serum reach the blood cell stop film 9, they do not pass through the blood cell stop film 9. Therefore, blood cells are not mixed into the plasma or serum stored in the internal space A1.

  As shown in FIG. 4, the flow path closing member 8 gradually swells when contacted with plasma or serum, and closes the flow path after the plasma or serum to be accommodated has passed. More specifically, after the plasma or serum that has moved relatively quickly in the blood separating material 6 passes through the flow path portion where the flow path closing member 8 is disposed, the flow path closing member 8 swells. That is, the hole 8a of the flow path closing member 8 is closed, and the flow path closing member 8 closes the flow path.

  As shown in FIG. 5, when taking out the plasma or serum stored in the internal space A1, the sample collection container 1 is preferably set so that the first opening 2a is on the lower side and the second opening 2b is on the upper side. Flip upside down. In the present invention, since the flow path is closed by the flow path closing member 8, the sample collection container 1 can be turned upside down, and the plasma or serum stored in the second internal space A2 is the blood separation material. 6 is not reached. That is, the separated plasma or serum is prevented from coming into contact with the blood cell or erythrocyte components and contaminating the plasma or serum.

  As shown in FIG. 5, when taking out the separated plasma or serum, the second stopper 4 press-fitted into the second opening 2b is removed. Thereafter, plasma or serum can be transferred from the second opening 2b to another container using a spoid or the like and used for clinical examination. Alternatively, plasma or serum can be taken directly from the nozzle of the testing device.

  In the present invention, since the inner peripheral surface of the container body 2 is tapered 2e and the liquid level of plasma or serum is brought close to the second opening 2b, the plasma or serum can be taken out more easily. Is possible.

  A specimen collection container according to a second embodiment of the present invention is shown in a front view in FIG. 6A and a front sectional view in FIG. 6B.

  The specimen collection container 21 shown in FIGS. 6A and 6B is the same as that described above except that the shape of the first opening and the shape of the first stopper provided in the first opening are different. The sample collection container 1 is configured in the same manner. In the following description of the sample collection container 21, the same configuration as the sample collection container 1 is denoted by the same reference numeral, and the description thereof is omitted.

  The sample collection container 21 has a cylindrical container body 22 having a first opening 22a on one end side and a second opening 22b on the other end side. In the present embodiment, the first opening 22a and the second opening 22b have the same opening diameter. An annular protrusion 22 c is provided on the inner peripheral surface of the container body 22 between the flow path closing member 8 and the second internal space A2. The annular protrusion 22c forms an opening 22d surrounded by the annular protrusion 22c, and constitutes a hollow flow path. A taper 22e is attached to the annular protrusion 22c on the inner peripheral surface of the container body 22 toward the first opening 22a.

  A first plug body 23 is attached to the first opening 22a so as to hermetically seal the inside. The first plug body 23 has a large diameter portion 23a and a small diameter portion 23b. The large diameter portion 23a has a larger diameter than the small diameter portion 23b. The large diameter portion 23a has a diameter larger than the outer diameter of the container body. In order to facilitate piercing with a blood collection needle or a syringe, a hemispherical recess 23 c is provided at the center of the outer surface of the first stopper 23. The small diameter portion 23b is press-fitted into the first opening 22a, and the first opening 22a is hermetically sealed by the first plug body 23.

  On the other hand, the second opening 22b is hermetically sealed using the second plug 4 whose outer surface is covered by the cover 5, and the inside of the sample collection container 21 is decompressed.

  The outer surface of the first plug body 23 is covered with a cover 24. In the present embodiment, the cover 24 is provided with a hole 24a in the concave portion 23c of the first plug 23 so that the first plug 23 is pierced by a blood collection needle or syringe.

  The cover 24 extends further upward from the outer peripheral side surface of the large-diameter portion 23a, and the upper end 24b of the cover 24 reaches the outer peripheral side surface of the first opening 22a. An annular protrusion 24 c is formed on the inner peripheral side surface of the cover 24. The inner diameter of the cover 24 is equal to or slightly smaller than the outer diameter of the large diameter portion 23a, but the inner diameter of the annular protrusion 24c is equal to or slightly smaller than the outer diameter of the small diameter portion 23b. That is, the front end surface 24d of the annular protrusion 24c is in contact with the outer peripheral side surface of the small diameter portion 23b, and the side surface 24e of the annular protrusion 24c is in contact with the step portion 23c between the large diameter portion 23a and the small diameter portion 23b. ing. On the other hand, a plurality of steps 24f are formed on the outer peripheral side surface of the cover 24 so that the cover 24 can be easily removed together with the first plug 23 so that it can be easily gripped.

  When the first plug 23 having the above-described shape and having the outer surface covered by the cover 24 is attached to the first opening 22a as in the present embodiment, The blood collection needle can be easily inserted and removed from the first stopper 23 while holding the container body 22 and the cover 24 with fingers. Moreover, it is easy to remove the cover 24 together with the first plug body 23. Furthermore, after separating the blood, it is easy to erect the sample collection container 21 so that the first opening 22a is on the lower side and the second opening 22b is on the upper side.

  A specimen collection container according to a third embodiment of the present invention is shown in a front view in FIG. 7 (a) and a front sectional view in FIG. 7 (b).

  The sample collection container 31 shown in FIGS. 7A and 7B is the same as the sample collection container 1 described above except that the shape of the second stopper attached to the second opening is different. It is configured.

  A second plug 32 is attached to the second opening 2b so as to hermetically seal the inside. The second plug 32 has a large diameter portion 32a having a truncated cone shape and a small diameter portion 32b. The large diameter portion 32a has a larger diameter than the small diameter portion 32b. The large diameter portion 32a has a diameter larger than the outer diameter of the container body. In order to facilitate piercing with a blood collection needle or syringe, a recess 32c is provided at the center of the outer surface of the second stopper 32, and a recess 32d is provided at the center of the inner surface of the second stopper 32. Is provided. The small diameter portion 32b is press-fitted into the second opening 2b, and the second opening 2b is hermetically sealed by the second plug body 32.

  In the case where the second stopper 32 is configured to be pierced by a blood collection needle or syringe as in the present embodiment, after separating the blood, the plasma contained in the internal space A1 or Serum can be collected using a blood collection needle or syringe. Therefore, since it is not necessary to remove the second plug 32 when taking out the plasma or serum, it is possible to prevent the plasma or serum from overflowing from the second opening 2b.

(A) And (b) is the front view and front sectional drawing which show the sample collection container which concerns on the 1st Embodiment of this invention. It is a figure for demonstrating the usage method of the sample collection container which concerns on the 1st Embodiment of this invention, and front sectional drawing which shows the state before piercing the syringe from which the blood was extract | collected in the sample collection container. It is a figure for demonstrating the usage method of the sample collection container which concerns on the 1st Embodiment of this invention, and the front which shows the state of the middle stage which is making blood flow in into the sample collection container from the syringe from which the blood was collected Sectional drawing. It is a figure for demonstrating the usage method of the sample collection container which concerns on the 1st Embodiment of this invention, and front sectional drawing which shows the state after isolate | separated plasma or serum was accommodated in internal space. It is a figure for demonstrating the usage method of the sample collection container which concerns on the 1st Embodiment of this invention, and front sectional drawing which shows a state when taking out the plasma or serum isolate | separated from the sample collection container. (A) And (b) is the front view and front sectional drawing which show the sample collection container which concerns on the 2nd Embodiment of this invention. (A) And (b) is the front view and front sectional drawing which show the sample collection container which concerns on the 3rd Embodiment of this invention. Front sectional drawing which shows an example of the conventional sample collection container.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Sample collection container 2 ... Container main body 2a, 2b ... 1st, 2nd opening 2c ... Annular protrusion 2d ... Opening part 2e ... Taper 3 ... 1st stopper 3a ... Large diameter part 3b ... Small diameter part 3c ... Concave part 4 ... second plug 4a ... large diameter part 4b ... small diameter part 4c ... stepped part 5 ... cover 5a ... lower end 5b ... annular protrusion 5c ... tip surface 5d ... side surface 5e ... step 6 ... blood separating material 6a ... surface DESCRIPTION OF SYMBOLS 7 ... Blood diffusion material 8 ... Flow-path obstruction | occlusion member 8a ... Hole 9 ... Blood cell stop membrane 9a ... Hole 11 ... Syringe 12 ... Hollow needle 12a ... Needle tip 13 ... Hub 21 ... Sample collection container 22 ... Container main body 22a, 22b ... No. DESCRIPTION OF SYMBOLS 1, 2nd opening 22c ... annular protrusion 22d ... opening 22e ... taper 23 ... 1st plug body 23a ... large diameter part 23b ... small diameter part 23c ... recessed part 24 ... cover 24a ... hole 24b ... upper end 24c ... annular protrusion Part 24d ... tip surface 24e ... side surface 24f ... Level difference 31 ... Sample collection container 32 ... Second stopper 32a ... Large diameter portion 32b ... Small diameter portion 32c, 32d ... Concavity A1 ... Internal space

Claims (7)

A specimen collection container used for separating plasma or serum from blood and examining components in the plasma or serum,
A cylindrical container body having a first opening on one end side and a second opening on the other end side;
A first stopper attached to the first opening of the container body; a second stopper attached to the second opening of the container body;
A blood separation material that is disposed on the first opening side of the container body and that separates blood into blood cells and plasma or serum;
The container body is disposed on the second opening side, and has an internal space for accommodating plasma or serum separated from blood,
The blood introduced from the first opening of the container body is disposed between the first stopper and the blood separating material so that the blood comes into contact with the blood separating material, and the blood A specimen collection container further comprising a blood diffusion material for allowing blood to flow into the blood separation material while diffusing blood in multiple directions.   The specimen collection container according to claim 1, further comprising a blood cell stopping membrane that is disposed between the blood separation material and the internal space and prevents passage of blood cells separated by the blood separation material.   A flow path closing member that is disposed between the blood separation material and the internal space, swells when contacted with plasma or serum separated by the blood separation material, and closes the flow path; The specimen collection container according to claim 1 or 2.   The specimen collection container according to claim 3, wherein the flow path blocking member is disposed between the blood cell stop film and the internal space.   The outer surface of the second plug body is covered with a cover that prevents the second plug body from being pierced by a blood collection needle or a syringe. Sample collection container.   The specimen collection container according to any one of claims 1 to 5, wherein an inner peripheral surface of the cylindrical container body is tapered toward the first opening side of the container body. The said 1st, 2nd stopper is airtightly attached to the 1st, 2nd opening of the said container main body, The inside of the said container main body is pressure-reduced, The any one of Claims 1-6 The specimen collection container according to Item.

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