WO2007057947A1 - Unite filtrante pour separer le sang et tube d’echantillonnage sous vide - Google Patents

Unite filtrante pour separer le sang et tube d’echantillonnage sous vide Download PDF

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Publication number
WO2007057947A1
WO2007057947A1 PCT/JP2005/020999 JP2005020999W WO2007057947A1 WO 2007057947 A1 WO2007057947 A1 WO 2007057947A1 JP 2005020999 W JP2005020999 W JP 2005020999W WO 2007057947 A1 WO2007057947 A1 WO 2007057947A1
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WO
WIPO (PCT)
Prior art keywords
blood
water
separation filter
swellable polymer
plasma
Prior art date
Application number
PCT/JP2005/020999
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English (en)
Japanese (ja)
Inventor
Katsuya Togawa
Masahiro Nakaizumi
Original Assignee
Sekisui Chemical Co., Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sekisui Chemical Co., Ltd. filed Critical Sekisui Chemical Co., Ltd.
Priority to PCT/JP2005/020999 priority Critical patent/WO2007057947A1/fr
Publication of WO2007057947A1 publication Critical patent/WO2007057947A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/165—Filtering accessories, e.g. blood filters, filters for infusion liquids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • G01N33/49—Blood
    • G01N33/491—Blood by separating the blood components

Definitions

  • the present invention relates to a blood separation filter device and a vacuum specimen collection tube for separating blood into blood cell components and plasma or serum.
  • centrifugation has been used to remove blood cell components from blood and obtain plasma or serum necessary for clinical examination.
  • centrifugation has been cumbersome, such as the clotting process and the process of transferring the supernatant plasma or serum after separation.
  • Patent Document 1 has pores having a diameter of 0.05 to 1 ⁇ m, an outer surface opening ratio of 40% or less, an inner surface opening ratio of 60% or more, and a film thickness of 50 to 200.
  • a method of separating and collecting plasma from whole blood using hollow fibers of / ⁇ ⁇ has been proposed. By using this hollow fiber, it is said that plasma can be separated at a high plasma separation rate.
  • Patent Document 2 plasma or serum is obtained from whole blood using a glass fiber layer having an average fiber diameter of 0.2 to 5 ⁇ m and a density of 0.1 to 0.5 gZ cm 3 . A method of separation is disclosed.
  • Patent Document 3 discloses a plasma or serum separation filter in which a filter medium composed of a polymer microfiber assembly or a porous polymer is mounted in a container having an inlet and an outlet. And A hydrophilic polymer is fixed to the polymer ultrafine fiber aggregate or porous polymer that is a filtering material in order to make it hydrophilic.
  • the immobilized hydrophilic polymer automatically stops filtration by moving blood through the filter media, swelling during plasma or serum separation and collection, and closing the filter. After obtaining a certain amount of plasma or serum, the filtration automatically stops until the blood cell component arrives. It is said that it can automatically prevent contamination.
  • Patent Document 1 Japanese Patent Publication No. 2-23831
  • Patent Document 2 Japanese Patent Publication No. 6-64054
  • Patent Document 3 Japanese Patent Laid-Open No. 11-285607
  • the hydrophilic polymer swells while blood is separated and collected into blood cell components and plasma or serum, and the filter is automatically closed, thereby closing the filter. Therefore, even when left for a long time after separation, there is no possibility that the components in the red blood cells are mixed into the plasma or serum due to hemolysis.
  • blood is moved in the filter medium, and blood cell components in blood and plasma or serum are separated by a difference in moving speed.
  • the difference in the moving speed is different, and in some cases, the filter may be clogged during the separation. If the filter is blocked during separation, the amount of sample that can be collected is greatly reduced.
  • a blood separation filter device includes a flow channel forming member having a flow channel through which blood flows, and a blood separation filter that is disposed in the flow channel and separates bloody blood components into blood cell components and plasma or serum.
  • the blood-swellable polymer-powered blood separation filter and the blood cell stop filter are disposed.
  • the water-swellable polymer is disposed downstream of the blood cell stop filter.
  • the water-swellable polymer is formed into a sheet shape.
  • At least a part of the flow path forming member forming the flow path downstream of the blood cell stop filter is a water-swellable polymer. It is formed by the molded body.
  • the water-swellable polymer is arranged in a mixture with a thermoplastic resin.
  • a vacuum sample collection tube of the present invention includes a blood separation filter device configured according to the present invention.
  • the blood cell stop filter is disposed downstream of the blood separation filter in the flow path through which blood flows.
  • the hemostasis filter prevents red blood cells from passing through. Therefore, it is possible to separate the blood into the blood cell component and the plasma or serum by using the difference in moving speed between the blood cell component and plasma or serum in the blood separation filter, and to prevent the passage of red blood cells in the blood cell stop filter. Therefore, blood can be more effectively separated into blood cell components and plasma or serum. Even when hematocrit or blood of different viscosities is used, plasma or serum can be obtained in a short time in order to effectively prevent the passage of red blood cells.
  • a water-swellable polymer is disposed downstream from the blood separation filter. If the device is left after the blood is separated into plasma or serum by the blood separation filter and the blood cell stop filter, the water-swellable polymer in contact with the plasma or serum swells and the flow path is blocked. Therefore, it is possible to prevent the components leaked from red blood cells due to hemolysis from being mixed into plasma or serum.
  • the blood separation filter device of the present invention it is possible to provide a vacuum sample collection tube that makes it possible to obtain plasma or serum free from contamination of erythrocyte components by hemolysis.
  • FIG. 1 is a front sectional view of a vacuum specimen collection tube according to an embodiment of the present invention.
  • FIG. 2 is an enlarged front sectional view showing the blood separation filter device shown in FIG.
  • FIG. 3 is a front sectional view of a modification of the blood separation filter device according to the present invention.
  • FIG. 4 is a front sectional view of another modification of the blood separation filter device according to the present invention.
  • FIG. 5 is a front sectional view of still another modified example of the blood separation filter device according to the present invention.
  • FIG. 6 is a front sectional view of another modified example of the blood separation filter device according to the present invention.
  • FIG. 7 is a front sectional view showing another embodiment of the blood separation filter device according to the present invention.
  • FIG. 8 is not desired between the blood cell stop filter and the flow path forming member in the blood separation filter device of the embodiment shown in FIG. A gap is formed!
  • FIG. 8 (b) is a front sectional view showing a state after the water-swellable polymer expands in the structure of (a).
  • Fig. 9 is configured in the same manner as the blood separation filter device shown in Fig. 2, but there is an undesired gap between the blood cell stop filter and the flow path forming member. It is a front sectional view for explaining a problem in a non-defective product.
  • FIG. 10 is a front sectional view of another modification of the blood separation filter device according to the present invention. is there.
  • FIG. 11 is a front cross-sectional view of still another modification of the blood separation filter device according to the present invention.
  • FIG. 12 is a graph showing the relationship between the blood separation time of hematogrit 25% in Example 3 and the amount of sample collected.
  • FIG. 13 is a graph showing the relationship between the blood separation time of hematogrit 25% in Comparative Example 1 and the sample collection amount.
  • the material of the blood separation filter used in the present invention is not particularly limited as long as it is a filter having a property of moving plasma or serum faster than blood cell components.
  • a fiber made of a synthetic polymer such as polyester, polyethylene, polypropylene, or polyamide is used.
  • Use glass fiber or porous polymer is used.
  • the blood separation filter may adsorb a measurement component in blood.
  • surface treatment may be performed.
  • Hydrophobic polymers such as polyether type
  • hydrophilic polymers such as polybulal alcohol or polybulyl pyrrolidone
  • natural hydrophilic macromolecules such as polybulal alcohol or polybulyl pyrrolidone
  • natural hydrophilic macromolecules such as polybulal alcohol or polybulyl pyrrolidone
  • macromolecule Surfactant etc. are mentioned.
  • the average fiber diameter is preferably 0.2 to 5.0 m in order to move plasma or serum faster than the blood cell component. If the average fiber diameter is less than 0.2 m, hemolysis tends to occur when separating blood, and if the average fiber diameter is greater than 5.0 m, blood cell components and plasma or serum are separated. Therefore, it is necessary to form a high density, and the amount of fibers to be used is increased, resulting in an increase in cost. In order to enhance the blood separation effect, the average fiber diameter is more preferably 0.5 to 3. O / zm.
  • the material of the blood cell stopping filter is not particularly limited as long as it is a filter that can prevent passage of red blood cells.
  • Such materials include, for example, polyvinylidene difluoride, polytetrafluoroethylene, cellulose acetate, nitrocellulose, polycarbonate, polyethylene terephthalate, polyethylene, polypropylene, glass fiber, borosilicate, salt tubule or silver. Etc.
  • the blood cell stopping filter has a porous material force, it is not particularly limited as long as it has a pore size within a range that allows passage of plasma or serum and prevents passage of red blood cells.
  • the pore diameter is preferably 2 ⁇ m or less. Pore size If it is small, protein components in the blood may clog, so the pore size is preferably 0.05 m or more. In order to further enhance the effect of preventing the passage of red blood cells, the pore diameter is more preferably 0.1 to 1.5 m.
  • the surface of the blood cell stop filter is treated with a hydrophilic treatment.
  • hydrophilic treatment include plasma treatment, hydrophilic polymer coating, and the like, but are not limited thereto, and other methods may be used.
  • the material of the water-swellable polymer used in the present invention is not particularly limited.
  • the water-swellable polymer should have a hydrophilic functional group in the molecular skeleton, and should be capable of absorbing the same amount or more of water relative to its own weight. Are preferred.
  • water-swellable polymer examples include polyacrylic acid alkali metal salt-based resins or copolymers thereof and crosslinked products thereof, polyacrylamide-based resins or copolymers thereof and crosslinked products thereof, poly N— Buracetoamide resin or a copolymer thereof and a crosslinked product thereof, silicone resin or a copolymer thereof and a crosslinked product thereof, polyvinyl ether resin or a copolymer thereof and a crosslinked product thereof, a polyalkylene Examples thereof include a lenoxide series resin or a copolymer thereof and a cross-linked product thereof, polybulal alcohol, polybulylpyrrolidone or a copolymer thereof and a cross-linked product thereof.
  • the water-swellable polymer may be added in the form of a powder, granular filter, paste, slurry, or solution that may be used in the form of a sheet, and dried. Etc.
  • the water-swellable polymer swells itself when contacted with plasma or serum, and blocks the flow path. Therefore, the required amount of the water-swellable polymer varies depending on the flow path volume, and the optimum amount of water-swellable polymer swelling rate and swelling speed force are calculated.
  • the channel volume to be occluded is set in a range in which moisture in the blood is absorbed and the collected amount of the sample does not decrease.
  • 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.
  • the flow path volume for closing is preferably 0.005 to 1. Ocm 3 .
  • the volume of the water-swellable polymer is preferably 5 to 95% with respect to the clogged channel deposition. If the volume of water-swellable polymer is less than 5% of the clogged channel deposit, Specimens with hemolyzed plasma or serum separated due to longer time to block the tract
  • 1S May contaminate separated plasma or serum. If the volume of water-swellable polymer is greater than 95% of the clogged flow path deposit, the flow path may be blocked before all the plasma or serum is collected, resulting in plasma or serum recovery. Efficiency may decrease.
  • FIG. 1 is a front sectional view showing a vacuum specimen collection tube according to one embodiment of the present invention.
  • the vacuum specimen collection tube 1 has a bottomed cylindrical tubular container 2 having an opening 2a at the upper end and a round bottom 2b at the lower end.
  • a plug 3 is attached to the opening 2a so as to hermetically seal the inside.
  • Cylindrical blood separation filter device 4 is arranged so that the upper part of the inner side of tubular container 2 is in close contact with the inner wall of tubular container 2 over the middle part. Note that the vacuum sample collection tube 1 is depressurized.
  • FIG. 2 is an enlarged front sectional view showing the blood separation filter device 4 of FIG.
  • the blood separation filter device 4 includes a flow path forming member 5, a blood separation filter 6, a blood cell stop filter 7, and a water swellable polymer 8.
  • the flow path forming member 5 includes a cylindrical member 9 and a main surface member 10.
  • the cylindrical member 9 is in close contact with the inner wall of the tubular container 2 from the upper step to the middle step inside the tubular container 2.
  • the cylindrical member 9 has an opening 9a at the upper end.
  • An annular peripheral edge portion 9c is provided slightly above the lower end 9b of the cylindrical member 9 so as to protrude inward from the inner peripheral surface of the cylindrical member 9.
  • An opening 9d surrounded by the annular peripheral portion 9c is formed by the annular peripheral portion 9c.
  • the main surface member 10 includes a main surface portion 10a and a tubular outlet portion 10b extending downward from the center of the main surface portion 10a.
  • the outlet portion 10b has a hollow channel extending vertically.
  • a concave portion 10c is provided in the center of the upper surface of the main surface portion 10a.
  • the area around the recess 10c is the annular protrusion 10d.
  • the concave portion 10c of the main surface portion 10a is connected to the hollow flow path of the outlet portion 10b, and constitutes a part of the flow path.
  • the main surface member 10 is disposed below the annular peripheral edge 9c of the cylindrical member 9. More specifically, the cylindrical member 9 is open at the lower end 9b, and the main surface member 10 is inserted and fixed from this opening portion. That is, the outer peripheral edge of the main surface portion 10a of the main surface member 10 is in close contact with and fixed to the inner peripheral surface of the cylindrical member 9. In this state, the upper surface of the main surface portion 10a is opposed to the annular peripheral edge portion 9c and the opening 9d of the cylindrical member 9. Further, the upper end surface of the annular convex portion 10d is spaced apart from the lower surface of the annular peripheral portion 9c of the cylindrical member 9 by a certain distance.
  • the blood separation filter 6 that separates blood into blood cell components and plasma or serum is disposed on the annular peripheral edge 9 c of the cylindrical member 9.
  • the blood cell stop filter 7 for preventing the mixing of blood cell components is a space downstream of the blood separation filter 6 and between the annular peripheral edge portion 9c of the cylindrical member 9 and the main surface portion 10a of the main surface member 10. Is arranged. More specifically, the blood cell stop filter 7 is disposed so as to be sandwiched between the lower surface of the annular peripheral edge portion 9c and the upper end surface of the annular convex portion 10d.
  • the water-swellable polymer 8 is disposed between the blood separation filter 6 and the blood cell stop filter 7 and in an opening surrounded by the annular peripheral edge 9c of the cylindrical member 9.
  • the water-swellable polymer 8 is dispersedly arranged so as to secure a flow path through which plasma or serum flows in the initial state, that is, before swelling.
  • Plasma or serum moves faster than the blood cell component. Plasma or serum that has moved relatively quickly reaches the blood cell stop filter 7 first and passes through the blood cell stop filter 7. Then, the plasma or serum passes through the hollow channel of the outlet portion 10 b through the concave portion 10 c of the main surface portion 10 a of the main surface member 10 and is accommodated in the tubular container 2.
  • the water-swellable polymer 8 gradually swells upon contact 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 fast in the blood separation filter 6 passes through the flow path portion where the water-swellable polymer 8 is disposed, the water-swellable polymer 8 swells. That is, the water-swellable polymer 8 expands so as to seal the opening 9d surrounded by the annular peripheral edge 9c. Therefore, the flow path is blocked by the expansion of the water-swellable polymer 8.
  • FIG. 3 is a front sectional view showing a blood separation filter device 11 which is another embodiment of the blood separation filter device 4.
  • the water-swellable polymer is arranged as a mixture 12 of the water-swellable polymer and the thermoplastic resin.
  • a mixture 12 of the water-swellable polymer and the thermoplastic resin 12 is disposed between the blood cell stop filter 7 and the main surface portion 10a of the main surface member 10, and is disposed in the concave portion 10c at the center of the upper surface of the main surface portion 10a. .
  • the mixture 12 of the water-swellable polymer and the thermoplastic resin is dispersed and arranged so as to secure an initial state, that is, a flow path for plasma or serum to flow before swelling.
  • the blood separation filter device 11 is formed in the same manner as the blood separation filter device 4 shown in FIG. 2, except that the arrangement part and the material of the water-swellable polymer are different.
  • the water-swellable polymer is used to block the flow path by contact with the separated plasma or serum and prevent passage of components in erythrocytes due to hemolysis. Accordingly, the position of the water-swellable polymer is not limited as long as the above function is achieved. Therefore, the water-swellable polymer may be disposed further downstream of the blood cell stop filter. [0058] In addition, as long as the water-swellable polymer can swell when contacted with separated plasma or serum and can serve to block the flow path, it can be thermoplastic as in the embodiment shown in FIG. May be arranged in the form of a mixture with fat!
  • FIG. 4 is a front sectional view showing another embodiment of the blood separation filter device of the present invention.
  • the lower surface portion 23a and the outlet portion 23b of the main surface member 23 of the flow path forming member 22 are formed of a water-swellable polymer molded body.
  • the main surface member 23 also has a forming force of the water-swellable polymer, and the opening 9d above the blood cell stop filter 7, that is, surrounded by the annular peripheral edge 9c described above.
  • the water-swellable polymer is disposed in the same manner as the blood separation filter device 4 except for the above.
  • the main surface member 23 is formed of a water-swellable polymer.
  • plasma or serum can flow downward through the recess 23c and the outlet 23b.
  • the water-swellable polymer begins to swell when contacted with the separated plasma or serum. As a result, after the plasma or serum to be collected flows downward, the expansion ends and the flow path 23b is blocked.
  • At least one of the flow path forming members forming the flow path is closed by the water-swellable polymer molded body, and the flow path is closed by expansion, downstream of the blood cell stop filter. It may be formed so that it can be. In that case, the flow path is blocked even in this case, and the passage of the components in the erythrocytes due to hemolysis can be prevented.
  • FIG. 5 is a front sectional view showing a modification of the blood separation filter device.
  • only the outlet portion 33b of the main surface member 33 of the flow path forming member 32 is formed of a molded body made of a mixture of water-swellable polymer and thermoplastic resin.
  • the blood separation filter device 31 is formed in the same manner as the blood separation filter device 21 shown in FIG. 4 except that the arrangement part, material, and properties of the water-swellable polymer are different.
  • a part of the flow path forming member 33 may be composed of a mixture of a water-swellable polymer and a thermoplastic resin.
  • the water-swellable polymer and the thermoplastic resin are blended so that the flow path can be reliably closed. Select a percentage. In this case, it is desirable to determine the blending ratio of the water-swellable polymer and the thermoplastic resin in consideration of the expansion rate and expansion rate of the water-swellable polymer.
  • FIG. 6 is a front sectional view showing still another embodiment of the blood separation filter device of the present invention.
  • a water-swellable polymer 42 formed into a sheet shape is used.
  • the mesh sheet-like water-swellable polymer 42 is disposed on the annular peripheral portion 9c of the cylindrical member 9 and the opening 9d surrounded by the annular peripheral portion 9c.
  • the blood separation filter 6 is disposed on a water-swellable polymer 42 in the form of a mesh sheet.
  • the blood separation filter device 41 is the same as the blood separation filter device 4 shown in Fig. 2 except that the arrangement part of the water-swellable polymer is different and the arrangement of the blood separation filter 6 is different. Is formed.
  • the water-swellable polymer 42 in the form of a mesh sheet has a large number of holes through which the separated plasma or serum can flow downward. And after expansion
  • a water-swellable polymer 42 in the form of a mesh sheet is used. Therefore, even after the separation, even if the water-swellable polymer 42 expands sufficiently and hemolysis occurs above, The downward flow can be prevented.
  • the process of assembling the blood separation filter device can be simplified, and further, the swelling speed of the water-swellable polymer can be stabilized. Can do.
  • FIG. 7 is a front sectional view showing still another embodiment of the blood separation filter device of the present invention.
  • a blood cell stop filter 51 is disposed on the lower surface of the annular peripheral edge portion 9c.
  • a sheet-like water-swellable polymer 53 is laminated on the lower surface of the blood cell stop filter 52.
  • the water-swellable polymer 53 is not necessarily in the form of a sheet, but a laminate composed of these may be disposed between the lower surface of the annular peripheral edge portion 9c and the upper surface of the annular convex portion 10d. preferable.
  • the water-swellable polymer is It is located downstream of the blood cell stop filter 52.
  • the blood separation filter device 4 shown in FIG. 2 When the blood separation filter device 4 shown in FIG. 2 is manufactured, there is a possibility that the blood separation filter device 101 as a defective product shown in FIG.
  • the blood separation filter device 101 shown in FIG. 9 in the lower surface member 10, the height of a part of the annular convex portion 1 Od is lowered as indicated by an arrow Z. Further, a part of the annular peripheral edge portion 9c is thinned above the portion indicated by the arrow Z.
  • the blood separation filter device 101 is configured in the same manner as the blood separation filter device 4. Therefore, the same reference numerals are assigned to the same parts. In this case, a gap is generated between the lower surface of the blood cell stop filter 7 and the annular convex portion 10d. Therefore, as shown by the arrow A, the red blood cells may flow around the blood cell stop filter 7 and flow toward the outlet b as shown by the arrow A.
  • red blood cells may not be reliably captured by the blood cell stop filter 7.
  • the blood separation filter device 61 shown in FIG. 10 is configured in the same way as the blood separation filter device 51 except that the water-swellable polymer 63 is disposed on the upper surface of the blood cell stop filter 62.
  • water-swellable polymers 73 and 74 are arranged on both the upper surface and the lower surface of the blood cell stop filter 72.
  • a sheet-like water-swellable polymer is disposed on at least one side of the blood cell stopping filter. Therefore, even if the size of the annular convex portion 10 on the lower surface member 10 varies or the diameter of the blood cell stop filter varies, the red blood cell can be reliably captured by the blood cell stop filter. It is possible to reliably prevent red blood cells from being mixed into the collected sample.
  • the blood separation filter device is capable of reducing various applications and modifications within the scope of the invention which is not limited to the above embodiment in other points. .
  • the pressure in the tube can be adjusted, so that a necessary amount of blood can be collected easily, The blood can be effectively separated into blood cell components and plasma or serum.
  • a cylindrical tubular container is used for the vacuum sample collection tube, but the shape thereof is not particularly limited, and an elliptical or hexagonal container may be used.
  • the material of the tubular container used for the vacuum specimen collection tube is not particularly limited.
  • Thermoplastic resins such as ethylene-butyl alcohol copolymer, thermosetting resins such as unsaturated polyester resin, epoxy resin, and epoxy-acrylate resin, cellulose acetate, cellulose propionate , Modified natural resin such as ethyl cellulose, ethyl chitin, silicate glass such as soda lime glass, phosphoric acid glass and borosilicate glass, glass such as quartz glass, and those containing these as a main component, or these Conventional combinations such as those that combine And the like.
  • the plug used for the sample collection tube is attached to the plug 3 so as to seal the opening 2 a of the tubular container 2.
  • the stopper is impermeable to air, it can be used as a vacuum specimen collection tube.
  • the material of the plug body is not particularly limited, and includes at least one elastic body selected from natural rubber, synthetic rubber and thermoplastic elastomer, or a conventionally known material such as an aluminum laminate or an aluminum vapor-deposited sheet. It is done.
  • Examples 1 to 5 and Comparative Example 1 are the same blood separation filter devices in the embodiment of Fig. 1 except that the arrangement, material, and properties of the water-swellable polymer are different.
  • a vacuum sample collection tube was provided.
  • the blood separation filter was 0.5 g of polyester fiber having an average fiber diameter of 1.8 ⁇ m.
  • the hemostasis filter was a lysopore HTTP with a pore size of 0.4 m.
  • the flow path forming member was not formed as a water-swellable polymer molded body, and a plastic part was used.
  • the vacuum sample collection tube was sealed with a stopper, and the pressure in the tube was 25 kPa.
  • the water-swellable polymer was disposed between the blood separation filter 6 and the blood cell stop filter 7 shown in FIG. 2 and inside the annular peripheral edge 9c of the cylindrical member 9.
  • the water-swellable polymer was 3 mg of Sunfresh ST-500D (manufactured by Sundia Polymer Co., Ltd.).
  • the flow path volume at the addition position was about 0.013 cm 3 , and the volume of the water-swellable polymer was about 24% of the flow path volume.
  • the water-swellable polymer was disposed between the blood separation filter 6 and the blood cell stop filter 7 shown in FIG. 2 and inside the annular peripheral edge 9c of the cylindrical member 9.
  • the water-swellable polymer was 5 mg of Aqua Pearl A3 (manufactured by Sundia Polymer Co., Ltd.).
  • the channel volume at the addition position was about 0.013 cm 3 , and the volume of the water-swellable polymer was about 40% with respect to the channel volume.
  • the water-swellable polymer is a space between the blood cell stop filter 7 and the main surface portion 10a of the main surface member 10 shown in FIG. 3, and is disposed in the concave portion 10c at the center of the upper surface of the main surface portion 10a.
  • the channel volume at the addition position was about 0.053 cm 3 , and the volume of the water-swellable polymer was about 23% with respect to the channel volume.
  • the lower surface portion 23a and the outlet portion 23b of the main surface member 23 of the flow path forming member 22 shown in FIG. 4 were formed of a water-swellable polymer molded body.
  • the water-swellable polymer was a molded product of Aqua Coke TWB (Sumitomo Seika Co., Ltd.).
  • the diameter of the plasma or serum channel separated from the bottom surface and the outlet of the channel forming member is ⁇ 0.
  • the water-swellable polymer was disposed between the blood separation filter 6 and the blood cell stop filter 7 shown in FIG. 2 and inside the annular peripheral edge 9c of the cylindrical member 9.
  • the water-swellable polymer was 0.5 mg Aqua Pearl A3 (manufactured by Sundia Polymer Co., Ltd.).
  • the volume of the channel at the addition position was about 0.013 cm 3 , and the volume of the water-swellable polymer was about 4% of the channel volume.
  • the water-swellable polymer was not able to be placed in the misplaced area.
  • the blood separation filter devices of Examples 1 to 5 and Comparative Example 1 described above were each injected with blood of different hematoglits collected from three persons, and blood was separated.
  • FIG. 12 is a diagram showing the relationship between the blood separation time of hematogrit 25% and the amount of sample collected for the blood separation filter device of Example 3.
  • FIG. 12 is a diagram showing the relationship between the blood separation time of hematogrit 25% and the amount of sample collected for the blood separation filter device of Example 3.
  • FIG. 13 is a diagram showing the relationship between the blood separation time of hematogrit 25% and the amount of sample collected for the blood separation filter device of Comparative Example 1.
  • Example 3 as shown in FIG. 12, elution of plasma or serum that passed through the flow channel started 25 seconds after the start of blood separation, and the sample collection amount gradually increased. After 92 seconds, there was no increase in sample collection.
  • Comparative Example 1 As shown in FIG. The elution of the plasma or serum that passed through started, and the sample collection amount gradually increased. Furthermore, after elution of plasma or serum was completed after 150 seconds, contamination of erythrocyte components due to hemolysis was confirmed over time, and the amount of sample collected increased.
  • Example 1 5 and Comparative Example 1 only plasma or serum was collected for 2 minutes after the start of blood separation, and no contamination of blood cell components into plasma or serum was observed. Blood separation fill This is because the blood cell component was separated from the plasma and serum by the difference in moving speed, and the blood cell stop filter prevented the passage of red blood cells.
  • Comparative Example 1 3 minutes after the start of the separation of blood, erythrocyte components were mixed into plasma or serum due to hemolysis. In Comparative Example 1, since the water-swellable polymer was not disposed, the flow path of the erythrocyte component due to hemolysis was not blocked, and contamination of the erythrocyte component due to hemolysis into the plasma or serum could not be prevented.
  • Example 5 since a water-swellable polymer was arranged, it took a longer time for components in the red blood cells due to hemolysis to mix with plasma or serum than in Comparative Example 1. This is because the water-swellable polymer was not perfect, but the flow path of the erythrocyte component due to hemolysis was blocked.
  • the blood separation filter device of Example 5 is different from Example 1 only in the amount of the water-swellable polymer used.
  • the amount of water-swellable polymer used was 3 mg in Example 1, but 0.5 mg in Example 5.
  • the volume of the water-swellable polymer was about 4% with respect to the channel volume.
  • Example 5 since the amount of the water-swellable polymer used was small, it took a long time to block the flow path of the erythrocyte component due to hemolysis. For this reason, it is considered that the contamination of erythrocyte components into the plasma or serum due to hemolysis was completely prevented.

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Abstract

La présente invention a pour but de proposer une unité filtrante pour séparer le sang par laquelle le sang peut être séparé en composants de cellules sanguines et plasma ou sérum sur une courte période de temps même dans le cas d’utilisation de sangs à hématocrite ou viscosité différents tout en évitant la contamination avec des composés provenant d’érythrocytes par l'intermédiaire d’une hémolyse lorsqu’on laisse le sang séparé reposer longtemps après la séparation ; et un tube d’échantillonnage sous vide comportant cette unité. Elle concerne également une unité filtrante destinée à séparer le sang comportant un élément de formation de canal qui est doté d’un canal à travers lequel le sang circule, un filtre de séparation de sang qui est formé dans le canal et par lequel le sang est séparé en composants de cellules sanguines et le plasma ou le sérum, un filtre bloquant les cellules sanguines qui est formé en aval du filtre de séparation du sang dans le canal et par lequel la contamination avec les composants de cellules sanguines est évitée, et un polymère gonflant à l’eau qui est prévu en aval du filtre de séparation du sang dans le canal et gonfle lors d’un contact avec le plasma ou le sérum afin de fermer ainsi le canal ; et un tube d’échantillonnage sous vide.
PCT/JP2005/020999 2005-11-16 2005-11-16 Unite filtrante pour separer le sang et tube d’echantillonnage sous vide WO2007057947A1 (fr)

Priority Applications (1)

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PCT/JP2005/020999 WO2007057947A1 (fr) 2005-11-16 2005-11-16 Unite filtrante pour separer le sang et tube d’echantillonnage sous vide

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PCT/JP2005/020999 WO2007057947A1 (fr) 2005-11-16 2005-11-16 Unite filtrante pour separer le sang et tube d’echantillonnage sous vide

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11267463A (ja) * 1998-03-25 1999-10-05 Toyobo Co Ltd 血漿または血清分離フィルター
JP2003220053A (ja) * 2001-08-30 2003-08-05 Becton Dickinson & Co 改良型血液バリアー性を有する血液ガス注射器
JP2004325412A (ja) * 2003-04-28 2004-11-18 Sekisui Chem Co Ltd 血液検査用容器

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11267463A (ja) * 1998-03-25 1999-10-05 Toyobo Co Ltd 血漿または血清分離フィルター
JP2003220053A (ja) * 2001-08-30 2003-08-05 Becton Dickinson & Co 改良型血液バリアー性を有する血液ガス注射器
JP2004325412A (ja) * 2003-04-28 2004-11-18 Sekisui Chem Co Ltd 血液検査用容器

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