JP2008232876A - Hemocyte stop membrane, blood separation filter, blood separator, and specimen sampling container - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a hemocyte stop membrane capable of collecting a plasma and a serum from blood in a short time, hardly generating blocking and hemolysis in a midway of separation, capable of reducing the number of items and capable of reducing a cost, and a blood separation filter, a blood separator and a specimen sampling container, which are respectively provided with the hemocyte stop membrane. <P>SOLUTION: The present invention discloses the hemocyte stop membrane 3 used for capturing a hemocyte component from the blood to collect the plasma and the serum, having valve point pressure within a range of 1.3-4.5 kg/cm<SP>2</SP>, and having 32 mL/min/cm<SP>2</SP>of water flow rate under 0.7 kg/cm<SP>2</SP>of pressure, and the blood separation filter, the blood separator 1 and the specimen sampling container 11 which are provided with the hemocyte stop membrane 3, and a blood separation member 4 capable of passing more quickly the plasma or the serum than the hemocyte component. <P>COPYRIGHT: (C)2009,JPO&INPIT

Description

  The present invention relates to a blood cell stop membrane used for collecting plasma or serum from blood, and more specifically, blood cells capable of capturing blood cell components in blood and collecting plasma or serum in a short time. The present invention relates to a stop membrane, a blood separation filter provided with the blood cell stop membrane, a blood separation device, and a specimen collection container.

  Conventionally, centrifugation has been used to remove blood cells from blood and obtain plasma or serum necessary for clinical examination. However, in the centrifugal separation method, the operation of transferring the supernatant plasma or serum after separation is 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 separation apparatuses that can remove blood cells from blood and obtain plasma or serum necessary for clinical examination without using a centrifuge have been proposed.

  For example, Patent Document 1 below discloses a plasma or serum separation filter in which a filter medium is mounted in a container having an inlet and an outlet. The filter medium is composed of a polymer microfiber assembly or a porous polymer. A hydrophilic polymer is fixed to the polymer microfiber aggregate or the porous polymer.

  In Patent Document 1, the hydrophilic polymer swells while blood is moved in the filter medium and plasma or serum is separated and collected. Due to the swelling of the hydrophilic polymer, the filter is blocked and the filtration is automatically stopped. It is said that, after collecting a predetermined amount of plasma or serum, filtration automatically stops until blood cells arrive, so that it is possible to automatically prevent blood cells from being mixed into the plasma or serum.

  On the other hand, in Patent Document 2 below, a blood separation filter that separates blood into blood cell components and plasma or serum in a flow channel forming member having a flow channel through which blood flows, and a blood cell stop that prevents mixing of blood cell components A blood separation filter device comprising a filter and a water-swellable polymer that swells when contacted with plasma or serum and closes the flow path is disclosed.

In Patent Document 2, when passing through a blood separation filter, blood is separated into a blood cell component and plasma or serum due to a difference in moving speed. Moreover, the passage of blood cell components is prevented by the blood cell stop filter disposed downstream of the blood separation filter. Furthermore, after collecting a predetermined amount of plasma or serum, the water-swellable polymer swells and the channel is blocked.
JP 11-285607 A Japanese Patent No. 3809457

  In Patent Document 1, since the hydrophilic polymer swells and the filter is blocked, it is possible to automatically prevent blood cells from being mixed into plasma or serum.

  However, in Patent Document 1, blood cells and plasma or serum are separated due to a difference in moving speed in the filter medium. When separation is performed based on the above-described difference in moving speed, for example, the moving speed difference is different in blood with different hematocrit and viscosity. In some cases, the filter is blocked during the separation, and the amount of collected sample may be greatly reduced. In addition, blood cells may pass through the filter and become contaminated with plasma or serum before the filter is occluded.

  On the other hand, in Patent Document 2, since a blood cell stop filter is provided, blood cells can be captured from blood and plasma or serum can be effectively separated even if hematocrit or blood with different viscosities is used. Further, since the flow path is blocked by the water-swellable polymer, there is no possibility that the components in the erythrocytes are mixed into the plasma or serum even if hemolysis occurs due to standing for a long time after the collection of plasma or serum.

  However, in Patent Document 2, there is a problem that the amount of the specimen decreases due to the mechanism in which the water-swelling polymer swells by the separated specimen and the flow path is blocked. In addition, since the flow path is blocked by the water-swellable polymer, it is possible to prevent some of the red blood cell components from being mixed into the plasma or serum. However, when a water-swellable polymer is placed, the number of parts increases, and the parts Costs and processing costs tend to be high.

  The object of the present invention is to allow plasma or serum to be collected from blood in a short time in view of the current state of the prior art described above, to prevent clogging or hemolysis during separation, to reduce the number of parts, and to reduce costs. An object of the present invention is to provide a blood cell stop membrane that can be used, and a blood separation filter, a blood separation device, and a specimen collection container provided with the blood cell stop membrane.

The present invention relates to a blood cell stopping membrane used for capturing blood cell components from blood and collecting plasma or serum, wherein the bubble point pressure is in the range of 1.3 to 4.5 kg / cm ² , and 0 The water flow rate under a pressure of 0.7 kg / cm ² is 32 mL / min / cm ² or less.

  In one specific aspect of the present invention, the blood cell stop membrane has a hydrophilic surface.

  The blood separation filter according to the present invention includes a blood cell stop membrane configured according to the present invention, and a blood separation member through which plasma or serum passes faster than blood cell components.

  A blood separation device according to the present invention includes a blood separation filter configured according to the present invention, a first opening that is an inlet for blood, and a second opening that is an outlet for blood, and a flow of blood. The blood separation filter is installed in the flow path so that the blood separation member is on the upstream side.

  In a specific aspect of the blood separation device according to the present invention, the first and second openings are hermetically sealed with a stopper, and the inside is decompressed to 5 to 90 kPa.

  A specimen collection container according to the present invention includes a blood separation device configured according to the present invention, and a tubular container having an opening at one end and a bottom at the other end. The first opening of the flow path forming member and the opening of the tubular container are hermetically sealed by a stopper so that the first opening is on the opening side of the tubular container. And the inside is decompressed to 5 to 90 kPa.

The blood cells stop layer according to the present invention, there bubble point pressure in the range of 1.3～4.5Kg / cm ^2, and the water flow rate under a pressure of 0.7 kg / cm ² is 32 mL / min / cm ² or less Therefore, plasma or serum can be collected from blood in a short time. In addition, it is possible to suppress the blood cell stop membrane from being blocked during the separation or to prevent hemolysis due to the blood cell stop membrane. Furthermore, since hemolysis is unlikely to occur, there is no need to use an extra member for closing the flow path downstream of the blood cell stop membrane during separation, and the number of parts can be reduced and the cost can be reduced.

  When the surface is hydrophilic, it is possible to further suppress occlusion and hemolysis during the separation.

  Since the blood separation filter according to the present invention includes the blood cell stop membrane and a blood separation member through which plasma or serum passes faster than blood cell components, blood is more reliably separated into blood cells and plasma or serum. be able to.

  In the blood separation apparatus according to the present invention, the flow separation path includes the blood separation filter, a first opening that is a blood inlet, and a second opening that is a blood outlet, and a flow path through which blood flows. Since the forming member is provided, blood can be separated more easily.

  When the first and second openings of the flow path forming member are hermetically sealed by a plug and the inside is decompressed to 5 to 90 kPa, blood separation is performed in a shorter time. be able to.

  In the sample collection container according to the present invention, the blood separation device is accommodated in the tubular container so that the first opening of the flow path forming member is on the opening side of the tubular container, and the first opening of the flow path forming member is Since the opening of the tubular container is hermetically sealed by a stopper and the inside is decompressed to 5 to 90 kPa, separation can be performed in a short time, and contamination of red blood cell components due to hemolysis No plasma or serum can be obtained easily.

  Details of the present invention will be described below.

  The blood cell stop membrane according to the present invention is used for capturing blood cell components from blood and collecting plasma or serum.

In the present invention, there bubble point pressure of the blood cells stop layer is in the range of 1.3～4.5Kg / cm ^2, and the water flow rate under a pressure of 0.7 kg / cm ² is 32 mL / min / cm ² or less is there.

  The bubble point pressure is expressed by P = K4δcos θ / d (P: bubble point pressure, K: shape correction coefficient, δ: liquid surface tension, d: pore diameter, θ: contact angle of liquid with solid) It is defined as the pressure required to push out liquid when it is held inside the membrane.

When the bubble point pressure is less than 1.3 kg / cm ² , hemolysis tends to occur when blood cell components are captured, and when it is greater than 4.5 kg / cm ² , plasma or serum is clogged during filtration. And the sample may not be sufficiently collected.

When the water flow rate under the pressure of 0.7 kg / cm ² exceeds 32 mL / min / cm ² , the flow rate is too high, and when the blood cell components are captured, they are easily destroyed, and the red blood cell components are stopped. Passes through the membrane in a short time. Therefore, components in erythrocytes are mixed into the separated plasma or serum, and normal test results cannot be obtained.

  The material constituting the blood cell stopping membrane is not particularly limited, but polyvinylidene difluoride, polyethersulfone, cellulose mixed ester, polycarbonate, polytetrafluoroethylene, nylon, polypropylene, polyethersulfone, polysulfone, acrylic copolymer Examples include coalescence.

The blood cell stopping membrane preferably has a hydrophilic surface. As described above, the bubble point pressure varies depending on the pore diameter of the blood cell stop membrane, the surface tension of the liquid, the contact angle, and the like. Therefore, the bubble point pressure can be easily set in the range of 1.3 to 4.5 kg / cm ² by increasing the hydrophilicity of the blood cell stopping membrane. In addition, it is preferable that the amount of protein or lipid in plasma or serum adsorbed to the blood cell stop membrane is small, and also in this respect, the surface of the blood cell stop membrane is preferably hydrophilic. In order to make the surface hydrophilic, the blood cell stopping film is preferably made of a hydrophilic material or coated with a hydrophilic treatment agent.

  Although it does not specifically limit as said hydrophilic material, The thing which has hydrophilicity among the materials which comprise the said blood cell stop film | membrane is used.

  The hydrophilic treatment agent is not particularly limited, and examples thereof include hydrophilic polymers. Specific examples include polyvinyl pyrrolidone, polyvinyl alcohol, hydroxyethyl cellulose, hydroxypropyl cellulose, hydrophilic silicone, and a low molecular surfactant.

  The blood cell stop membrane may be used in combination with a blood separation member through which plasma or serum passes faster than blood cell components.

  In a blood separation filter provided with a blood cell stop membrane and a blood separation member, blood can be more reliably separated into blood cells and plasma or serum by using a difference in moving speed due to the blood separation member.

  The blood separating member is not particularly limited as long as plasma or serum passes faster than blood cell components. For example, the pore size that can move plasma or serum faster than the blood cell component, the number of pores that can secure a practical filtration time, that is, the porosity, and the movement of plasma or serum in the process of blood filtration are physically or chemically A shape having a shape that does not hinder the process is used.

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

  Specific examples of the blood separation member include, for example, a product in which fibers formed from the above materials are accumulated in a nonwoven fabric, a molded body such as an open-cell foam in which continuous pores are formed using the above materials, and the above materials. What is formed by integrating shaped spherical fine particles so as to have a finely packed structure, or integrally formed by sintering this accumulated material, or having a through hole formed in a film formed from the above material, or film And a sheet in which a large number of sheets processed by corona discharge or press working are laminated on one side or both sides.

  The average pore diameter of the blood separation member is preferably in the range of 2 to 10 μm in order to enable separation of blood cell components and plasma or serum due to a difference in moving speed, and to prevent damage to blood cell components, that is, destruction of red blood cells. Preferably it is the range of 3-8 micrometers. When the average pore diameter is smaller than 2 μm, blood cell components are clogged in the blood separation member and filtration is hindered, or resistance to the blood cell components is increased during filtration and red blood cells are easily destroyed. When the average pore diameter exceeds 10 μm, the difference in moving speed between the blood cell component and plasma or serum becomes small, and the blood cell component easily reaches the blood cell stop membrane in a short time. The average pore diameter can be measured by a bubble point test method (JIS K 3832), an actual measurement method using an enlarged image by an electron microscope, or the like.

  The porosity of the blood separation member is preferably in the range of 20 to 97%, more preferably in the range of 30 to 95% in order to ensure a practical filtration time. If the porosity is lower than 20%, it takes a long time for filtration and the destruction of red blood cells tends to occur. If the porosity is higher than 97%, the shape retention of the blood separation filter is lowered, and the blood separation member may be deformed by the pressure during filtration and the pore diameter may change, so that blood separation cannot be performed stably. There is.

  When using the blood separation filter, it is preferable that the blood separation member is disposed upstream and the blood cell stop membrane is disposed downstream of the blood flow direction. In this case, since blood plasma or serum passes through the blood cell stop membrane before the blood cell component reaches the blood cell stop membrane, the blood separation efficiency can be further enhanced.

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

  FIG. 1 is a front sectional view showing a blood separation device according to an embodiment of the present invention.

  As shown in FIG. 1, the blood separation device 1 includes a flow path forming member 2, a blood separation member 3, and a blood cell stop film 4. That is, the blood separation device 1 includes a blood separation filter including a blood separation member 3 and a blood cell stop membrane 4. The blood separation filter is installed in the flow path of the flow path forming member 2.

As the blood separation member 3 and the blood cell stop film 4, those described above are used. Specifically, the blood separation member 3 is configured such that plasma or serum passes faster than blood cell components. Further, the bubble point pressure of the blood cell stop layer 4 is in the range of 1.3～4.5Kg / cm ^2, and the water flow rate under a pressure of 0.7 kg / cm ² is 32 mL / min / cm ² or less It is said that.

  The flow path forming member 2 has a first opening 2a that is an inlet of blood at the upper end and a second opening 2b that is an outlet of blood at the lower end, and has a flow path through which blood flows.

  The flow path forming member 2 includes a cylindrical member 5 having a cylindrical shape and a bottom member 6. The cylindrical member 5 has an upper end 5a opened. An annular peripheral edge 5c is provided slightly above the lower end 5b of the cylindrical member 5 so as to protrude inward from the inner peripheral surface of the cylindrical member 5. The annular peripheral edge 5c forms an opening 5d surrounded by the annular peripheral edge 5c.

  The bottom member 6 has a main surface portion 6a and an annular outlet portion 6b extending downward from the center of the main surface portion 6a. The outlet portion 6b has a hollow channel extending vertically. An annular protrusion 6d is provided on the upper surface of the main surface portion 6a. A portion surrounded by the annular protrusion 6d is a recess 6c. The recessed part 6c is connected to the hollow flow path of the outlet part 6b, and constitutes a part of the flow path.

  The bottom member 6 is disposed below the annular peripheral edge 5c. Specifically, the cylindrical member 5 is open at the lower end 5b, and the bottom member 6 is inserted and fixed from this opening. That is, the outer peripheral surface of the main surface portion 6a is in close contact with and fixed to the inner peripheral surface of the cylindrical member 5. In this state, the upper surface of the main surface 6a is opposed to the annular peripheral edge 5c and the opening 5d.

  The flow path forming member 2 has first and second openings 2 a and 2 b, but the first opening 2 a is at the upper end 5 a of the tubular member 5, and the second opening 2 b is the outlet portion 6 b of the bottom member 6. It is in.

  It does not specifically limit as a material which comprises the flow path formation member 2, For example, synthetic resins, such as polyethylene, a polypropylene, a polyethylene terephthalate, are mentioned. The flow path forming member 2 is preferably air impermeable. The flow path forming member 2 may be improved in air impermeability by depositing metal, silicon, or the like on the surface.

  The flow path forming member 2 has a cylindrical shape, but may have a rectangular tube shape.

  The blood separating member 3 is disposed on the annular peripheral edge 5 c in the cylindrical member 5. The outer peripheral surface of the blood separating member 3 is in close contact with the inner peripheral surface of the tubular member 5.

  The blood cell stop film 4 is disposed in a space between the annular peripheral edge 5 c and the main surface 6 a in the cylindrical member 5. Specifically, the blood cell stop membrane is disposed so as to be sandwiched between the lower surface of the annular peripheral edge 5c and the upper surface of the annular protrusion 6d.

  Therefore, the blood separation member 3 and the blood cell stop membrane 4 are installed in the flow path of the flow path forming member 2 so that the blood separation member 3 is upstream and the blood cell stop film 4 is downstream with respect to the direction of blood flow. ing.

  FIG. 2 is a front sectional view showing a sample collection container 11 in which a blood separation apparatus 1 according to an embodiment of the present invention is housed in a tubular container.

  As shown in FIG. 2, the tubular container 12 has an opening 12a at one end and a round bottom 12b at the other end. The blood separation device 1 is accommodated in the tubular container 12 such that the first opening 2a of the flow path forming member 2 is on the opening 12a side of the tubular container 12.

  The first opening 2 a of the flow path forming member 2 and the opening 12 a of the tubular container 12 are hermetically sealed by a plug body 13. The plug body 13 has a large diameter portion 13a, a medium diameter portion 13b, and a small diameter portion 13c. The large diameter portion 13 a has a diameter slightly larger than the outer diameter of the opening 12 a of the tubular container 12. The medium diameter portion 13b has a diameter substantially equal to the inner diameter of the opening 12a of the tubular container 12. The small diameter portion 13 has a diameter substantially equal to the inner diameter of the first opening 2 a of the flow path forming member 2.

  The plug 13 is 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 plug 13 include an elastic body such as natural rubber, butyl rubber, isoprene rubber, or thermoplastic elastomer.

  In the sample collection container 11, the medium diameter portion 13b is press-fitted into the opening 12a of the tubular container 12, and the opening 12a is hermetically sealed. The small diameter portion 13c is press-fitted into the first opening 2a of the flow path forming member 2, and the first opening 2a is hermetically sealed.

  The inside of the sample collection container 11 is depressurized. The inside of the sample collection container 11 is preferably decompressed to 5 to 90 kPa. If the pressure is lower than 5 kPa, red blood cells are destroyed during separation, and components in red blood are liable to leak. If the pressure is higher than 90 Pa, blood collection may not be performed quickly.

  When blood is collected and separated using the sample collection container 11, a blood collection needle or the like is pierced through the stopper 13, and blood is extracted from the first opening 2 a of the flow path forming member 2 to the upper end 3 a of the blood separation member 3. To supply. After supplying the blood, the blood collection needle is removed.

  The blood to be separated may be whole blood or blood diluted with an isotonic aqueous solution. Further, the blood is not limited to human blood, but may be blood from laboratory animals or livestock. Further, it may be fresh blood or blood to which an anticoagulant such as heparin, ethylenediaminetetraacetate or citric acid is added.

  When collecting blood, vacuum blood collection may be performed using a holder, or the syringe may be pierced through the plug body 13 after collecting blood in the syringe. After the blood is collected, the blood collection needle is preferably removed, but may remain pierced by the plug body 13.

  In the blood separation member 3, when blood passes, plasma or serum moves faster than blood cell components. Plasma or serum that has moved relatively quickly reaches the blood cell stop membrane 4 first and passes through the blood cell stop membrane 4. Plasma or serum flows down from the second opening 2 b of the flow path forming member 2 and is stored in the bottom 12 b of the tubular container 12.

  Even if the blood cell component that has moved relatively later than plasma or serum reaches the blood cell stop film 4, it does not pass through the blood cell stop film. Therefore, blood cell components are not mixed in the plasma or serum stored in the bottom 12b. Moreover, since the blood cell stop film | membrane 4 is comprised as mentioned above, the blood cell stop member is obstruct | occluded in the middle of isolation | separation, or generation | occurrence | production of the hemolysis by the blood cell stop member is suppressed. Therefore, many specimens can be collected, and plasma or serum free from contamination with red blood cell components can be obtained. Moreover, since the generation of hemolysis is suppressed, there is no need to use an extra member for closing the flow path, and the number of parts can be reduced and the cost can be reduced.

  Plasma or serum stored in the bottom 12b can be collected by, for example, removing the blood separating apparatus 1 from the opening 12a of the tubular container 12.

  Next, a blood separation device according to another embodiment of the present invention will be described with reference to FIG.

  As shown in FIG. 3, the blood separation device 21 includes a flow path forming member 22, a blood separation member 23, and a blood cell stop film 24. That is, the blood separation device 21 includes a blood separation filter including a blood separation member 23 and a blood cell stop film 24. The blood separation filter is installed in the flow path of the flow path forming member 22. The blood separation member 23 and the blood cell stop membrane 24 are configured in the same manner as the blood separation member 3 and the blood cell stop membrane 4 except that their sizes are different.

  The flow path forming member 22 has a cylindrical shape. The flow path forming member 22 has a first opening 22a which is a blood inlet and a second opening 22b which is a blood outlet at both ends, and a flow path through which blood flows. The first opening 22a of the flow path forming member 22 has a shape tapered to a truncated cone shape. The opening diameter of the first opening 22a is smaller than the opening diameter of the second opening 22b. The flow path forming member 22 can be configured using the same material as the flow path forming member 2.

  The flow path forming member 22 is not particularly limited. Specifically, considering the rack compatibility of general clinical laboratory equipment, for example, a member having a size up to an outer diameter of 16 mm and a length of 100 mm can be mentioned. .

  The first opening 22 a is hermetically sealed by the first plug body 25. The first plug body 25 has a large diameter portion 25a and a small diameter portion 25b having a smaller diameter than the large diameter portion 25a. The large diameter portion 25 a has a diameter substantially equal to the outer diameter of the first opening 22 a of the flow path forming member 22. An inverted frustoconical recess 25c is provided at the center of the outer surface of the first stopper 25 so that a blood collection needle or syringe can be easily inserted. The small diameter portion 25b is press-fitted into the first opening 22a.

  The second opening 22b is hermetically sealed by the second plug 26. The second plug 26 includes a large diameter portion 26a and a small diameter portion 26b having a smaller diameter than the large diameter portion 26a. The small diameter part 26b is press-fitted into the second opening 22b. The first and second plug bodies 25 and 26 can be configured using the same material as that of the plug body 13.

  The blood separator 21 is depressurized. The inside of the blood separation device 21 is preferably decompressed to 5 to 90 kPa.

  The outer surface of the second stopper 26 is covered with a cover 27 so that the blood collection needle or syringe is not pierced by the second stopper 26. The outer surface of the second plug 26 is preferably covered with a cover 27. When the cover 27 is provided, it is possible to prevent a blood collection needle or syringe from being accidentally pierced by the second stopper 26 and blood from being collected from the second stopper 26 side.

  Although it does not specifically limit as a material which comprises the cover 27, For example, a polypropylene, polyethylene, a polyethylene terephthalate, a polycarbonate etc. are mentioned.

  In the flow path forming member 22, an annular shelf 22 c is provided on the inner peripheral surface near the center in the length direction of the flow path forming member 22. An opening 22d surrounded by the annular shelf 22c is formed by the annular shelf 22c, and constitutes a hollow flow path. On the second opening 22b side, the annular shelf 22c has a taper 22e toward the first opening 22a side.

  The flow path forming member 22 has an annular protrusion 22f that protrudes inward from the inner peripheral surface of the flow path forming member 22 slightly closer to the first opening 22a than the annular shelf 22c.

  The blood cell stop film 23 is disposed on the annular protrusion 22 f in the flow path forming member 22. The outer peripheral surface of the blood cell stop film 23 is in close contact with the inner peripheral surface of the flow path forming member 22.

  The blood cell separation member 24 is disposed on the blood cell stop film 23 so as to be in contact with the upper surface of the blood cell stop film 23 in the cylindrical member 5. The outer peripheral surface of the blood cell separation member 24 is in close contact with the inner peripheral surface of the flow path forming member 22.

  Therefore, the blood separation member 23 and the blood cell stop film 24 are installed in the flow path of the flow path forming member 22 so that the blood separation member 23 is on the upstream side and the blood cell stop film 24 is on the downstream side with respect to the direction of blood flow. ing.

  In the blood separation device 21, blood is supplied from the first opening 22 a of the flow path forming member 22. The supplied blood passes through the blood separation member 23 and further passes through the blood cell stop film 24. Then, plasma or serum flows down from the opening 22 d of the flow path forming member 22 and is accommodated on the second opening 22 b side of the flow path forming member 22, that is, on the second plug 26. The plasma or serum stored on the second plug 26 can be taken out from the second opening 22b side.

  EXAMPLES Hereinafter, although an Example is hung up and this invention is demonstrated in more detail, this invention is not limited only to these Examples.

(Examples 1-6, Comparative Examples 1-3)
A blood separation apparatus shown in FIGS. 1 and 2 and a sample collection container equipped with the blood separation apparatus were produced.

  A flow path forming member 2 having a cylindrical shape with a diameter of about 11 mm was prepared. At the position shown in FIG. 1 in the flow path forming member 2, the blood cell stop membrane shown in Table 1 below was arranged. In addition, a blood separating member in which 0.55 g of a polyester ultrafine fiber having a diameter of about 1.8 μm was wound in a spiral shape was disposed at the position shown in FIG.

  As shown in FIG. 2, the blood separation device was housed in a bottomed tubular container, sealed with a stopper, and the inside was decompressed to 40 kPa to produce a sample collection container.

(Evaluation)
After injecting about 2 mL of human blood (hematocrit 40%) from the stopper of the sample collection container using a syringe, the stopper is immediately pierced with a hollow needle, and the blood inflow part is set to atmospheric pressure to separate the blood. It was. The specimen container in the container was decompressed during blood separation, and was left in that state after completion of blood separation to confirm hemolysis. After leaving for 60 minutes, the separated specimen was compared with the centrifuged serum to confirm the presence or absence of hemolysis. The results are shown in Table 2 below.

  In the sample collection containers of Examples 1 to 6, no hemolysis was observed, the sample collection amount was stable, and 320 to 340 μL of sample could be collected.

  On the other hand, in the sample collection containers of Comparative Examples 1 and 2, contamination of the hemolyzed sample was observed 5 minutes after the completion of blood separation. This is why the sample collection containers of Comparative Examples 1 and 2 have a larger amount of collected sample after 60 minutes than the sample collection containers of Examples 1 to 6. In Comparative Example 3, hemolysis was not observed, but the blood cell stop membrane was clogged during blood separation, and the amount of collected sample was small.

1 is a front sectional view showing a blood separation device according to an embodiment of the present invention. The front sectional view showing the sample collection container provided with the blood separation device concerning one embodiment of the present invention. Front sectional drawing which shows the blood separation apparatus which concerns on other embodiment of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 ... Blood separation apparatus 2 ... Flow path formation member 2a ... 1st opening 2b ... 2nd opening 3 ... Blood separation member 3a ... Upper end 4 ... Blood cell stop film 5 ... Cylindrical member 5a ... Upper end 5b ... Lower end 5c ... Annular Peripheral part 5d ... Opening part 6 ... Bottom member 6a ... Main surface part 6b ... Outlet part 6c ... Recessed part 6d ... Annular projection 11 ... Sample collection container 12 ... Tubular container 12a ... Opening 12b ... Bottom part 13 ... Plug 13a ... Large diameter part 13b ... Medium diameter part 13c ... Small diameter part 21 ... Blood separation device 22 ... Flow path forming member 22a ... First opening 22b ... Second opening 22c ... Annular shelf 22d ... Opening part 22e ... Taper 22f ... Annular protrusion 23 ... blood separation member 24 ... blood cell stop membrane 25 ... first plug body 25a ... large diameter part 25b ... small diameter part 25c ... concave part 26 ... second plug body 26a ... large diameter part 26b ... small diameter part 27 ... cover

Claims (6)

A blood cell arrest membrane used to capture blood cell components from blood and collect plasma or serum,
Wherein the bubble point pressure is in the range of 1.3～4.5Kg / cm ^2, and the water flow rate under a pressure of 0.7 kg / cm ² is 32 mL / min / cm ² or less, blood cells Stop membrane.   The blood cell stopping membrane according to claim 1, wherein the surface is hydrophilic. The blood cell arresting membrane according to claim 1 or 2,
A blood separation filter comprising a blood separation member through which plasma or serum passes faster than a blood cell component. A blood separation filter according to claim 3;
A flow path forming member having a first opening that is an inlet of blood and a second opening that is an outlet of blood, and having a flow path through which blood flows,
The blood separation device, wherein the blood separation filter is installed in the flow path so that the blood separation member is on the upstream side.   The blood separation device according to claim 4, wherein the first and second openings are hermetically sealed by a stopper and the inside is depressurized to 5 to 90 kPa. A blood separation device according to claim 4;
A tubular container having an opening at one end and a bottom at the other end;
The blood separation device is housed in the tubular container such that the first opening of the flow path forming member is on the opening side of the tubular container;
Sample collection, characterized in that the first opening of the flow path forming member and the opening of the tubular container are hermetically sealed by a stopper and the inside is decompressed to 5 to 90 kPa container.

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