JP2007003479A - Blood separation device - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a blood separation device capable of performing quickly and easily operation from blood collection to separation thereof into plasma or serum, and supplying the collected plasma or serum to an analyzer as a specimen as it is. <P>SOLUTION: This blood separation device 1 is constituted as follows: a blood separation filter 4 is stored inside a tubular container body 2; a plug body 3 pierceable by a hollow needle is fitted thereto so as to seal airtightly the first opening 2a; a gasket 7 is arranged in the second internal space 2d positioned on the second opening 2b side of the blood separation filter 4; an operation rod 8 is connected to the gasket 7; the outer circumferential surface of the gasket 7 is in contact airtightly with the inner circumferential surface of the tubular container body 2; the gasket 7 can be moved in the longitudinal direction of the tubular container body 2, while keeping the airtight contact state; and the first and second internal spaces 2c, 2d are depressurized. <P>COPYRIGHT: (C)2007,JPO&INPIT

Description

  The present invention relates to a blood separation device for separating plasma or serum from blood, and more specifically, blood separation that has a reduced pressure inside and that can separate plasma or serum from blood by a pressure difference. Relates to the device.

  Conventionally, centrifugation has been widely used to obtain plasma or serum in clinical tests and the like. However, the separation method using the centrifugal method has a problem that an expensive centrifuge is required and a relatively long time is required for the separation.

  In recent years, various filter devices have been proposed in order to remove blood cell components from blood and obtain plasma or serum necessary for clinical examination. The separation method using the filter device does not require a centrifuge, and therefore can reduce costs, space, and time for obtaining plasma or serum.

  For example, the following Patent Document 1 uses a blood test container having an opening, a stopper that hermetically seals the opening, a blood container, a serum container, and a filter that separates blood into serum or plasma. A rapid recovery method of serum or plasma from blood is disclosed.

However, in the configuration described in Patent Document 1, since the degree of decompression is determined in advance, it is difficult to make the pressure difference, which is the driving force for separation, correspond to blood with individual differences, and erythrocyte rupture occurs during separation. There was a case.
JP 2004-325412 A

  As described above, in the conventional blood separation filter device, in order to shorten the time required to obtain plasma or serum as compared with the centrifugal separation method, it is necessary to filter by applying a pressure difference. However, when a pressure difference is applied, hemolysis may occur, and thus there is a problem that an erroneous determination result or a test value varies in a clinical test using plasma or serum.

  In view of the current state of the prior art described above, the object of the present invention is to enable quick and easy operations from collection of blood to separation of blood into blood cell components and plasma or serum. Alternatively, it is possible to provide a blood separation apparatus that can separate the blood plasma or serum without causing hemolysis without allowing the blood serum to be grounded to the testing device as it is.

  According to the present invention, a tubular container body provided with a first opening at one end and a second opening at the other end, and stored in the tubular container body, blood A blood separation filter for separating blood cell components and plasma or serum, the first opening side of the blood separation filter being a first internal space in which blood is collected, and the blood separation The second opening is separated from the filter by the second internal space for containing plasma or serum, the first and second internal spaces are decompressed, and the first opening is hermetically sealed. A stopper body made of a material fixed to the first opening and piercable by a hollow needle, and disposed in the second internal space of the blood separation filter, Having an outer peripheral surface in airtight contact with the inner peripheral surface of It is connected to the gasket and the gasket, and allows the gasket to be moved in a direction connecting the first and second openings of the tubular container body while maintaining a state of being in airtight contact with the inner peripheral surface of the tubular container, The blood separation device is further provided with an operation rod having an outer end portion located outside the tubular container body through the second opening of the tubular container body.

  In a specific aspect of the blood separation device according to the present invention, in the second internal space, a blood cell stop filter is provided downstream of the blood separation filter to pass only plasma or serum and prevent passage of blood cell components. The outer peripheral edge of the blood cell stop filter is fixed to the inner peripheral surface of the tubular container body.

  In another specific aspect of the blood separation device according to the present invention, a blood flow blocking member that swells by contact with a liquid component and blocks a flow path in the second internal space downstream of the blood separation filter is further provided. It has been.

  In another specific aspect of the blood separation device according to the present invention, the operation rod is formed of a cylindrical body, and the cylindrical body is a longitudinal direction of the tubular container. And a rod arranged so as to be able to move independently, wherein a through hole is formed in the gasket, and an airtight sealing member having an outer peripheral edge in airtight contact with an inner peripheral surface of the through hole of the gasket The hermetic sealing member is connected to the inner end of the rod, and the rod is moved in the length direction of the tubular container body so that the hermetic sealing member is removed from the through hole of the gasket. It can be removed.

  In the blood separation device according to the present invention, the blood separation filter is disposed in the tubular container body, the first internal space disposed on the upstream side of the blood separation filter, and the first disposed on the downstream side. The internal space of 2 is decompressed. The plug is attached so as to hermetically seal the first opening, and the plug is made of a material that can be pierced by a hollow needle, so that the plug is pierced by a blood collection needle or the like. Thus, blood can be collected in the first internal space. In addition, a gasket is arranged in the second internal space, the operation rod is connected to the gasket, the operation rod is operated, and the gasket is connected to the first and second openings of the tubular container body. Can be moved to. Accordingly, when collecting blood, the gasket is arranged on the blood separation filter side so that the second internal space becomes small, and then the operation rod is pulled out so that the volume of the second internal space is expanded. The pressure difference between the first internal space and the second internal space can be increased. Therefore, separation of blood in the blood separation filter can be started.

  As described above, in the blood separation filter, blood is separated into blood cell components and plasma or serum. Then, plasma or serum that is a liquid component is collected in the second internal space on the downstream side from the blood separation filter.

  After the separation, the collected plasma or serum can be immediately taken out from the second opening side by turning the tubular container body upside down and pulling out the operating rod from the tubular container body together with the gasket.

  When a transparent tubular container body is used, the tubular container body of the blood separation device storing the collected plasma or serum is supplied to an analyzer or the like employing an optical measuring method as it is for measurement. You can also Therefore, the process from the collection of blood to the separation of blood into blood cell components and plasma or serum can be performed quickly and easily in the blood separation apparatus of the present invention, and the complicated process for collecting a plug is required. The operation can be omitted.

  Further, in the blood separation device according to the present invention, blood is collected in a state where the first internal space is previously decompressed as described above, but by pulling out the gasket of the piston composed of the operation rod and the gasket, Blood separation is performed. Therefore, since blood collection and blood separation operation can be performed separately, hemolysis in the process of blood permeation into the upper surface of the blood separation filter can be suppressed. That is, it is possible to perform the separation operation after blood collection without reducing the initial decompression at the time of blood collection, that is, without reducing the pressure in the first and second internal spaces, thereby suppressing hemolysis. Can do.

  In addition, blood properties such as hematocrit and viscosity are usually different from person to person. Therefore, when blood is separated at a constant pressure, hemolysis may occur. On the other hand, when the blood separation device of the present invention is used, blood separation is started by moving the gasket. Therefore, in the case of blood that is susceptible to hemolysis, it is possible to reliably prevent hemolysis by operating so as to reduce the moving speed of the gasket.

  In addition, if the gasket is moved stepwise by operating the operating rod, the pressure during blood separation can be increased stepwise, and hemolysis can be suppressed accordingly.

  Furthermore, in the blood separation device of the present invention, after the separation, it is only necessary to pull out the gasket and the operating rod from the second opening as described above, and accordingly, the second internal space, that is, the collected plasma or serum is stored. There is no obstructive member in the space where the operation for extracting plasma or serum is performed. Therefore, the collected plasma or serum can be quickly taken out from the second opening side. Therefore, a part of plasma or serum can be easily taken out by a pipette or a collection tube of an automatic analyzer.

  In the present invention, in the second internal space, a blood cell stop filter that allows only plasma or serum to pass and blocks the passage of blood cell components is provided downstream of the blood separation filter, and the outer peripheral edge of the blood cell stop filter is tubular. When the blood vessel is fixed to the inner peripheral surface of the container body, after the blood cell component and plasma or serum are separated in the blood separation filter, only the separated plasma or serum passes through the blood cell stop filter, It is stored in the internal space. And since passage of a blood cell is reliably blocked | prevented by the blood cell stop filter, mixing of the blood cell component to the 2nd internal space side can be suppressed more reliably.

  In the case where a blood flow blocking member that swells due to contact with the liquid component downstream of the blood separation filter and blocks the flow path in the second internal space is provided, the first and second internal spaces Due to the pressure difference, the blood flow blocking member gradually swells while the filtration proceeds. And after filtration is complete | finished, the flow path in 2nd internal space will be interrupted | blocked by the said blood-flow interruption | blocking member, and the movement of plasma or serum or a blood cell component from the blood separation filter side is prevented further. Usually, even after filtration is complete, hemolysis occurs if some amount of blood, plasma, serum or blood cell components remain in the blood separation filter and left to stand. Therefore, if it is allowed to stand even after the filtration is stopped, the components in the blood cells generated by hemolysis may move to the second internal space side. However, when the flow path to the second internal space side is blocked by the blood flow blocking member, it is possible to reliably prevent the movement of the components in the blood cell caused by the hemolysis to the plug body. It becomes.

  In the present invention, the operating rod is made of a cylindrical body, and the rod is arranged in the cylindrical body constituting the operating rod so as to be able to move independently from the cylindrical body in the length direction of the tubular container body. And a hermetic sealing member that is inserted into the through hole of the gasket and has an outer peripheral edge that hermetically contacts the outer peripheral edge of the through hole of the gasket, and the hermetic sealing member is coupled to the inner end of the rod. And by moving the rod in the longitudinal direction of the tubular container body, the hermetic sealing member can be moved while maintaining hermetic contact with the inner peripheral surface of the gasket. After the filtration is completed, with the tubular container body turned upside down, the rod is operated to move the hermetic sealing member to the outside of the through hole of the gasket, so that the hermetic sealing state of the second inner space is achieved. It can be canceled. Therefore, by releasing the pressure reduction, the piston composed of the operation rod and the gasket and the second piston composed of the rod and the hermetic sealing member can be easily extracted from the second opening.

  Hereinafter, the present invention will be clarified by describing specific embodiments of the present invention with reference to the drawings.

  1 to 3 are a perspective view, a front view, and a front sectional view showing a blood separation device according to an embodiment of the present invention.

  The blood separation device 1 has a tubular container body 2. Although the tubular container body 2 is not particularly limited, it has a cylindrical shape, and has a first opening 2a at one end and a second opening 2b at the other end. The material which comprises the said tubular container main body 2 is not specifically limited, The synthetic resin which has gas barrier property, or glass is used. Preferably, the tubular container body 2 is preferably made of a transparent material so that the internal state can be visually confirmed and used as it is in an optical measurement method. Examples of such a transparent synthetic resin material include polyethylene terephthalate and polypropylene.

  The dimensions of the tubular container body 2 are not particularly limited, but considering the mounting property of a general analyzer rack, it is desirable that the outer dimensions are 16 mm and the length is 100 mm.

  The direction connecting the first opening 2 a and the second opening 2 b of the tubular container body 2 is the length direction of the tubular container body 2.

  The plug 3 is attached to the first opening 2a so as to hermetically seal the first opening 2a. The plug 3 can be made of an appropriate material as long as it has a hermetic seal and can be pierced by a hollow needle. Examples of such materials include elastic materials such as natural rubber, butyl rubber, and thermoplastic elastomer.

  A blood separation filter 4 is accommodated in the tubular container body 2. Examples of the blood separation filter 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 or on the surface of the filter, or may be separated by a difference in moving speed between the blood cell component and the plasma or serum component.

  Examples of the material for the blood separation filter include polyester, polyethylene, polypropylene, polyamide, cellulose, glass, polystyrene, ethylene fluoride, polycarbonate, polyether sulfone, polysulfone, and nylon, but are particularly limited. is not. The blood separation filter 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 filters are collectively referred to as symmetrical filters.

  Among these blood separation filters, 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 filters. 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.

  In the case where the blood separation filter 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 filter 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 ultrafine fiber aggregate 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 possible to use a combination of the symmetric filter and the asymmetric filter as the blood separation filter.

  The blood separation filter may have a property of adsorbing blood components. In this case, the blood separation filter 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. The surface of the blood separation filter 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.

  The internal space on the first opening 2a side of the blood separation filter 4 is the first internal space 2c, and the downstream side of the blood separation filter 4, that is, the internal space on the second opening 2b side is the second internal space 2d. It is.

  In the second internal space 2d, the blood cell stop filter 5 is disposed on the downstream side of the blood separation filter 4 in the present embodiment. The blood cell stop filter 5 has an outer peripheral edge fixed to the outer peripheral edge of the tubular container body 2, and the blood cell stop filter 5 is made of a material that allows liquid components such as plasma or serum to pass but does not allow red blood cells to pass. Has been. By providing such a blood cell stop filter 5, hemolysis of the blood cell component to the finally obtained plasma or serum can be more reliably prevented. However, the blood cell stop filter 5 is not an essential member in the present invention.

  The blood cell stop filter only needs to have a property of preventing passage of red blood cells, and the material thereof is not particularly limited. 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 hemostasis filter is constructed using a porous material, plasma or serum can pass through. The porous substance constituting the blood cell stopping filter is not particularly limited as long as it has a pore diameter 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 filter 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 blood flow blocking member 6 that can block the flow path in the second internal space 2d is disposed downstream of the blood cell stop filter 5. The blood flow blocking member 6 is made of a material that swells with moisture. Such a material is not particularly limited, but is preferably a water-swellable polymer 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 water-swellable polymer include polyacrylic acid alkali metal salt resins or copolymers thereof and cross-linked products thereof, polyacrylamide resins or copolymers thereof and cross-linked products thereof, and poly N-vinylacetamide type. Resin or copolymer thereof and cross-linked product thereof, silicon-based resin or copolymer thereof and cross-linked product thereof, polyvinyl ether resin and copolymer thereof and cross-linked product thereof, polyalkylene oxide resin or copolymer thereof And a crosslinked product thereof, polyvinyl alcohol, polyvinylpyrrolidone or a copolymer thereof, and a crosslinked product thereof.

  The water-swellable polymer may be used in the form of powder or granules, may be used in the form of a filter or sheet, and may be added in a paste, slurry or solution and dried. Also good.

  The water-swellable polymer swells itself when it comes into contact with plasma or serum, and blocks the flow path. Therefore, the required amount of the water-swellable polymer varies depending on the channel volume, and the optimum amount is calculated from the swelling rate and swelling speed of the water-swellable polymer.

  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 flow path volume is increased, the amount of the water-swellable polymer for blocking is increased, so that the recovery amount may be reduced.

Accordingly, the volume of the channel for closing is preferably 0.005 to 1.0 cm ³ . In addition, the volume of the water-swellable polymer is preferably 5 to 95% with respect to the flow path deposition that is blocked. If the volume of the water-swellable polymer is less than 5% of the flow path deposition that is blocked, the time until the flow path is blocked becomes longer, so that the sample from which the hemolyzed plasma or serum is separated is separated from the separated plasma or May contaminate serum. If the volume of the water-swellable polymer is greater than 95% of the blocked flow path deposit, the flow path may be blocked before all of the plasma or serum is recovered, resulting in plasma or serum recovery. Efficiency may be reduced.

  In this embodiment, it is comprised by the disk shaped member which has the through-hole 6a in the center, and the outer peripheral edge is being fixed to the internal peripheral surface of the tubular container main body 2. FIG. When the blood flow blocking member 6 swells, the through hole 6a is gradually narrowed and finally the through hole 6a is closed. The timing at which the through-hole 6a is closed by this swelling is set so that the blood flow is blocked after the blood separation is completed, as is apparent from the operation method described later. This timing is set by adjusting the material constituting the blood flow blocking member 6, the dimension of the through hole 6a, and the like.

  In the present embodiment, the blood flow blocking member 6 is formed of a disk-shaped member having the through-hole 6a in the center as described above. However, the blood flow blocking member 6 swells due to contact with moisture in the second internal space. As long as the flow path can be closed, the shape of the blood flow blocking member 6 can be changed as appropriate. In other words, a plurality of through-holes may be provided, an appropriate structure having a thin channel portion other than the through-hole extending in the length direction of the tubular container body 2 and capable of closing the thin channel portion by swelling. It can be.

  It should be pointed out that the blood flow blocking member 6 is not essential in the present invention. However, the provision of the blood flow blocking member 6 is desirable because it can more reliably prevent the components of the blood cells produced by the hemolysis after the separation operation from being mixed into the specimen.

  A gasket 7 is disposed on the downstream side of the blood flow blocking member 6.

  The outer peripheral edge of the gasket 7 is in airtight contact with the inner peripheral surface of the tubular container body 2, and the gasket 7 is configured to be movable in the length direction of the tubular container body 2 while maintaining this airtight contact state. Yes.

  FIG. 8 is a front view showing a structure in which the operation rod 8 and the gasket 7 are connected, and FIG. 9 is a front view and a front sectional view thereof. FIG. 10 is a schematic plan view of the gasket 7 as viewed from the blood separation filter 4 side. Although the material which comprises such a gasket 7 is not specifically limited, The appropriate material which can fulfill | perform the above effects is used. Preferably, the outer peripheral edge portion that contacts the inner peripheral surface of the tubular container body 2 is made of an elastic material such as natural rubber, butyl rubber, or thermoplastic elastomer. Thereby, the above-described hermetic sealing can be surely achieved.

  An operation rod 8 is connected to the outer main surface of the gasket 7. The operation rod 8 is pulled out to the outside of the tubular container body 2 and has an operation flange 8a at the outer end. The gasket 7 can be moved in the length direction of the tubular container body 2 by gripping the operation flange 8 a of the operation rod 8 by hand and moving it in the length direction of the tubular container body 2.

  Protrusions 8b, 8c, 8d are provided on the outer peripheral surface of the operation rod 8. The convex portions 8 b to 8 d are annular convex portions provided at different positions in the length direction of the tubular container body 2.

  On the other hand, on the inner peripheral surface of the tubular container body 2, an annular inward protruding portion 2e that engages with the convex portions 8b to 8d is provided. In a state where any one of the convex portions 8b to 8d is engaged with the annular inward projecting portion 2e, the movement is temporarily stopped when the operation rod 8 is pulled out. However, by increasing the pulling force by the operating rod 8, the convex portions 8b to 8d are configured to be able to move over the inwardly projecting portion 2e and move downward.

  In addition, the operation bar 8 is formed of a cylindrical body in the present embodiment.

  On the other hand, in this embodiment, the through-hole 7a is formed in the center of the gasket 7, and the airtight sealing member 9 is inserted in this through-hole 7a. The outer peripheral surface of the airtight sealing member 9 is in airtight contact with the inner peripheral surface of the through hole 7a. The hermetic sealing member 9 can be made of an appropriate material, but its outer peripheral surface is preferably made of an elastic material such as natural rubber, butyl rubber, or thermoplastic elastomer in order to achieve the above-described hermetic sealing. .

  The hermetic sealing member 9 is arranged so as to be movable in the length direction of the tubular container body 2 by an external force while being in airtight contact with the inner peripheral surface of the through hole 7a. A rod 10 is connected to the hermetic sealing member 9.

  FIG. 11 is a schematic plan sectional view of a structure in which the hermetic sealing member and the rod are connected. The rod 10 is inserted into the hollow portion of the operation rod 8 made of the cylindrical body, the inner end is fixed to the hermetic sealing member 9, and the operation flange 10a is provided at the outer end. . The operation flange 10 a is disposed outside the operation flange 8 a of the operation rod 8.

  The operation rod 8 and the rod 10 are formed of an appropriate rigid material as long as an operation for moving the gasket 7 and the hermetic sealing member 9 can be performed. Examples of such materials include synthetic resins and metals.

  In the blood separation device 1 of the present embodiment, the first internal space 2c and the second internal space 2d are depressurized to the extent necessary to collect blood by a method similar to the vacuum blood sampling method. The degree of decompression is not particularly limited, but if the degree of decompression is too high, hemolysis may occur when blood is collected. Therefore, the degree of decompression is desirably 90 kPa or less. If the degree of decompression is too low, blood cannot be collected. Therefore, it is desirable that the degree of vacuum is higher than 10 kPa. More preferably, the degree of vacuum is in the range of 20 to 60 kPa. In the state before use, the gasket 7 is brought into contact with the surface opposite to the blood separation filter 4 of the blood flow blocking member 6 so that the volume of the second internal space 2d is minimized as shown in FIG. The hermetic sealing member 9 is inserted into the gasket 7.

  Next, with reference to FIGS. 4-7, the usage method of the said blood separation apparatus 1 is demonstrated.

  At the time of blood collection, as shown in FIG. 4, a blood collection needle 11 made of a hollow needle is pierced through the stopper 3. In this case, since the pressure in the first internal space 2c is reduced as described above, blood is collected in the first internal space 2c. Then, in order to start the separation of blood from that state, the operating rod 8 and the rod 10 are gripped by the operating flanges 8a and 10a and pulled out, and the gasket 7 is hermetically sealed as shown in FIG. It is moved together with the member 9 to the second opening 2b side. For this reason, the volume of the second internal space 2d is increased, and a pressure difference between the first internal space 2c and the second internal space 2d is generated, and filtration is started. That is, separation by the blood separation filter 4 is started by this pressure difference.

  In this case, the separation is performed based on a difference in moving speed between the blood cell component and plasma or serum. That is, in the blood separation filter 4, plasma or serum moves downward rapidly, and the movement of blood cell components is considerably slower than that. Therefore, the plasma or serum that has been separated first passes through the blood cell stop filter 5 from the lower end of the blood separation filter 4 and is collected in the second internal space 2d. In this way, plasma or serum 12a is collected.

  In the present embodiment, since the blood cell stop filter 5 is provided, even if red blood cells and white blood cells that have moved late arrive at the upper surface of the blood cell stop filter 5, they do not pass through the blood cell stop filter 5. Therefore, it is possible to reliably prevent blood cells from being mixed into plasma or serum 12a.

  When the filtration by the pressure difference is completed, the blood flow path is blocked by the blood flow blocking member 6 that has started swelling due to contact with the liquid component in the blood. That is, the blood flow blocking member 6 starts to swell together with the filtration tension, but since the blood flow is blocked at the timing after the filtration is completed, the blood separation is performed after the separation operation by the filtration is completed. The flow path is blocked.

  As shown in FIG. 5, if the separation operation is performed and left as it is after the separation operation, the red blood cells may be hemolyzed. In this case, due to hemolysis of red blood cells existing above the blood cell stop filter 5, the liquid component in the blood cells moves downward beyond the blood cell stop filter 5. However, when the flow path is blocked by the blood flow blocking member 6 as described above, it is possible to reliably prevent the components in the blood cells generated by such hemolysis from being mixed into the specimen.

  Next, as shown in FIG. 6, the tubular container body 2 is turned upside down. In this state, as shown in FIG. 6, the operation flange 10a is brought closer to the operation flange 8a side, and the hermetic sealing member 9 is removed from the through hole 7a. Therefore, the second internal space 2d communicates with the outside air, and the decompression is released. Therefore, the gasket 7 can be pulled out of the tubular container body 2 together with the hermetic sealing member 9 and the rod 10 by pulling out the operation rod 8. In this way, as shown in FIG. 7, plasma or serum 12a as a specimen can be reliably and accurately collected as a clean specimen in the second internal space 2d.

  Since the dimensions of the tubular container body 2 are set as described above, the tubular container body 2 can be mounted on the rack of the analyzer as it is, and the tubular container body 2 is used immediately after the sample is collected by the analyzer.

  Therefore, by using the blood separation device 1 of the present embodiment, the steps from blood collection to sample collection can be performed easily and promptly without requiring complicated procedures. In addition, there is little risk of infection due to contact of workers with blood. Moreover, since the separation operation is started by pulling out the operation rod 8, the influence of hemolysis can be effectively suppressed. That is, since it is not necessary to reduce the pressure in the second internal space 2d too low in advance, hemolysis can be prevented. Moreover, hemolysis can be prevented by slowing the moving speed of the operating rod 8 at the start of the separation operation or by moving it in stages. This stepwise movement can be easily performed by utilizing the engagement between the convex portions 8b to 8d and the inward protruding portion 2e.

  As the separation progresses, the blood cell component reaches the blood cell stop filter 5 and the through hole of the blood cell stop filter 5 is clogged. In this way, filtration is stopped.

  12 to 14 are a front view, a side view, and a front sectional view for explaining a blood separation filter device according to a modification of the embodiment. In this embodiment, the airtight sealing member 9 and the operation rod 10 constituting the second piston are not provided, the operation rod 8 is constituted by a solid rod-like member, and the tubular container body 2 has an opening 2f formed on the side surface thereof, and is configured in the same manner as the blood separation device 1 of the above embodiment except that the opening 2f is provided with a plug 22.

  As in the present embodiment, the operation rod 8 may be a solid member, and the rod 10 and the hermetic sealing member 9 may be omitted.

  That is, in the above-described embodiment, as shown in FIG. 6, the decompression of the opening 2 d is released by removing the hermetic sealing member 9 from the gasket 7. On the other hand, in this modification, the decompression of the second internal space after the sample collection is released using the opening 2f. That is, the plug 22 is attached so as to hermetically seal the opening 2f, but is easily detachably attached by hand. Examples of the material constituting the plug body 22 include appropriate elastic materials such as natural rubber, synthetic rubber, and thermoplastic elastomer.

  As shown in FIGS. 15 and 16, the operating rod 8 is moved downward from the state shown in FIG. 14 during the separation operation, and the gasket 7 is moved to the second opening 2d side from the opening 2f. Is done. Therefore, as shown in FIG. 17, after the separation operation is completed, the internal space 2d can be communicated with the atmosphere by removing the plug body 22 with the tubular container body 2 turned upside down. Therefore, the gasket 7 and the operating rod 8 can be easily pulled out from the second opening 2d side. Then, as shown in FIG. 18, after the gasket 7 and the operating rod 8 are pulled out, the opening 2 f may be closed again by the plug 22.

The perspective view of the blood separation apparatus which concerns on one Embodiment of this invention. The front view of the blood separation apparatus which concerns on one Embodiment of this invention. 1 is a front sectional view of a blood separation device according to an embodiment of the present invention. Front sectional drawing for demonstrating the process of blood-collecting using the blood separation apparatus of one Embodiment of this invention. Sectional drawing for demonstrating the process of isolate | separating the blood using the blood separation apparatus which concerns on one Embodiment of this invention. Front sectional drawing for demonstrating the process which reverses the tubular container main body up and down and cancels | releases decompression of 2nd interior space. The front sectional view showing the state where plasma or serum was collected in the blood separation device of one embodiment of the present invention. The front view which shows the operation stick | rod and gasket which are used with the blood separation apparatus shown in FIGS. Front sectional drawing which shows the operation stick | rod and gasket which are used with the blood separation apparatus shown in FIGS. 1-3. The top view which looked at the gasket from the blood separation filter side in embodiment shown in FIGS. 1-3. Front sectional drawing which shows the airtight sealing member and rod which are used for the blood separation apparatus shown in FIGS. 1-3. The front view of the blood separation apparatus which concerns on the modification of this invention. The side view of the blood separation apparatus which concerns on the modification of this invention. The front sectional view of the blood separation device concerning the modification of the present invention. Front sectional drawing which shows the process of collecting blood using the blood separation apparatus of the modification shown in FIGS. The front sectional view for explaining the process of starting separation operation using the blood separation device concerning a modification. The front sectional view for explaining the process of extracting an operation stick and a gasket in the blood separation device of a modification. The front sectional view showing the state where blood plasma or serum as a sample was collected in the blood separation device concerning a modification.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Blood separation apparatus 2 ... Tubular container main body 2c, 2d ... 1st, 2nd internal space 2e ... Opening 2f ... Opening 3 ... Plug body 4 ... Blood separation filter 5 ... Blood cell stop filter 6 ... Blood flow blocking member 6a ... Through hole 7 ... Gasket 7a ... Through hole 8 ... Operation rod 8a ... Operation flange 9 ... Airtight sealing member 10 ... Rod 10a ... Operation flange 11 ... Blood collection needle 12 ... Blood 12a ... Plasma or serum 21 ... Blood separation device 22 ... Plug body

Claims (4)

A tubular container body provided with a first opening at one end and a second opening at the other end;
The tubular container main body includes a blood separation filter for separating blood into a blood cell component and plasma or serum, and the first opening side of the blood separation filter collects blood at the first opening side. 1 is a second internal space for storing plasma or serum separated on the second opening side from the blood separation filter, and the first and second internal spaces are decompressed. Has been
A plug made of a material fixed to the first opening and piercable by a hollow needle so as to hermetically seal the first opening;
A gasket disposed in the second internal space of the blood separation filter and having an outer peripheral surface in airtight contact with an inner peripheral surface of the tubular container body;
The gasket is connected to the gasket, allows the gasket to be moved in a direction connecting the first and second openings of the tubular container body while maintaining an airtight contact with the inner peripheral surface of the tubular container, and an outer end. The blood separating apparatus according to claim 1, further comprising: an operating rod positioned outside the tubular container body through the second opening of the tubular container body. In the second internal space, a blood cell stop filter is provided downstream of the blood separation filter to pass only plasma or serum and prevent passage of blood cell components,
The blood separation device according to claim 1, wherein an outer peripheral edge of the blood cell stop filter is fixed to an inner peripheral surface of the tubular container body.   The blood separation device according to claim 1 or 2, further comprising a blood flow blocking member that swells by contact with a liquid component downstream of the blood separation filter and blocks a flow path in the second internal space. The operating rod is formed of a cylindrical body, and further includes a rod disposed in the cylindrical body constituting the operating rod so as to be able to move independently from the cylindrical body in the length direction of the tubular container. ,
A through hole is formed in the gasket, and further includes an airtight sealing member having an outer peripheral edge that is in airtight contact with an inner peripheral surface of the through hole of the gasket, and the airtight sealing member is provided at an inner end of the rod. Any one of claims 1 to 3, wherein the hermetic sealing member is connected and can be removed from the through hole of the gasket by moving the rod in the longitudinal direction of the tubular container body. The blood separation device according to claim 1.

Images