WO2022085489A1 - シリンジシステム - Google Patents

シリンジシステム Download PDF

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Publication number
WO2022085489A1
WO2022085489A1 PCT/JP2021/037347 JP2021037347W WO2022085489A1 WO 2022085489 A1 WO2022085489 A1 WO 2022085489A1 JP 2021037347 W JP2021037347 W JP 2021037347W WO 2022085489 A1 WO2022085489 A1 WO 2022085489A1
Authority
WO
WIPO (PCT)
Prior art keywords
buoy
syringe
syringe cylinder
gasket
liquid
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2021/037347
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
久 坂井
悠 森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Kyocera Corp
Original Assignee
Kyocera Corp
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 Kyocera Corp filed Critical Kyocera Corp
Priority to JP2022556914A priority Critical patent/JP7598941B2/ja
Priority to US18/033,255 priority patent/US20230329970A1/en
Publication of WO2022085489A1 publication Critical patent/WO2022085489A1/ja
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236—Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150244—Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150755—Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02—Blood transfusion apparatus
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • 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
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/3129—Syringe barrels

Definitions

  • the present disclosure relates to a syringe system for fractionating blood or the like to prepare a liquid containing a desired component.
  • a buoy-type suspension fractionation system or the like that fractionates blood or the like using a difference in specific density is known.
  • the syringe system includes a first syringe having a first syringe cylinder, and a second syringe having a second syringe cylinder movably connected from the first syringe to the inside of the first syringe cylinder. And at least one of a first floating marker located in the first syringe cylinder and a second floating marker located in the second syringe cylinder.
  • FIG. 1 shows the structural example of the preparation kit which includes the syringe system which concerns on Embodiment 1 of this disclosure.
  • It is sectional drawing which shows the example of the 1st buoy and the 2nd buoy which has a plurality of buoy members.
  • FIG. 1 It is a figure which shows the structural example of the preparation kit which includes the syringe system which the 3rd syringe can connect to the 2nd gasket. It is a figure which shows the structural example of the preparation kit which includes the syringe system which has the 3rd buoy. It is a figure which shows an example of the flow of the process of preparing PRP from blood using the preparation kit shown in FIG. It is a figure which shows an example of the flow of the process of preparing PRP from blood using the preparation kit shown in FIG. It is a figure which shows an example of the first half of the flow of the process of preparing PRP from blood using the preparation kit shown in FIG.
  • Embodiment 1 There is increasing interest in techniques and methods for fractionating a patient's own blood or the like to prepare a solution containing a desired component.
  • PRP platelet rich plasma
  • fractionation refers to a process of separating a liquid into two or more layers.
  • the “fraction” is, for example, a process of separating a liquid into two or more layers having different masses per unit volume of the principal component contained in each layer, or separating a liquid into two or more layers having different liquids in each layer. It is intended to be processed.
  • a syringe system 100 for preparing platelet-rich plasma (PRP) from blood will be described as an example.
  • the syringe system 100 can be utilized in the process of separating the components based on the specific densities of the components contained in various liquids.
  • the syringe system 100 can also be used, for example, in the process of separating a solution containing stem cells from bone marrow tissue or adipose tissue.
  • FIG. 1 is a diagram showing a configuration example of a preparation kit 110 including a syringe system 100.
  • the syringe system 100 includes a first syringe 10 having a first syringe cylinder 11 capable of storing liquid, a second syringe 20 having a second syringe cylinder 21 capable of storing liquid, and a buoy 50.
  • the buoy 50 includes at least one of a first buoy 51 located in the first syringe cylinder 11 and a second buoy 52 located in the second syringe cylinder 21.
  • the first buoy 51 is a buoy for the liquid to be fractionated stored in the first syringe cylinder 11
  • the second buoy 52 is a fraction target stored in the second syringe cylinder 21. It is a buoy for liquids.
  • FIG. 1 shows a syringe system 100 further comprising a first needle 90, but the first needle 90 is not an essential configuration of the syringe system 100.
  • the first syringe 10 may include a first gasket 14 that can be located within the first syringe cylinder 11. Further, the first syringe 10 may include a first plunger 12 (see FIG. 15 and the like) detachably provided on the first gasket 14.
  • the first syringe cylinder 11 can store the contained liquid.
  • the first syringe cylinder 11 together with the first gasket 14 constitutes at least a part of the first syringe 10.
  • a first port 13 (first tip portion) is arranged at one end of the first syringe cylinder 11.
  • the portion of the first syringe cylinder 11 for storing the liquid may have a substantially tubular shape.
  • the liquid stored in the first syringe cylinder 11 may be any liquid containing platelets.
  • the liquid stored in the first syringe cylinder 11 is (1) blood, (2) bone marrow fluid, (3) a fluid containing platelets collected from blood / bone marrow fluid / spleen, etc., and (4). ) It may be a liquid containing platelets produced in vitro (in vitro).
  • the first syringe cylinder 11 can be used as a centrifuge container.
  • Centrifugal force uses centrifugal force to create a heavy layer containing a heavy mass (ie, high density) component per unit volume and a light weight component containing a light mass (ie, low density) component per unit volume. It is a process of separating the layers and separating the heavy layer and the light layer.
  • a high density may be expressed as a large specific gravity
  • a low density may be expressed as a small specific gravity.
  • the blood contained in the first syringe tube 11 (that is, whole blood) is fractionated into a heavy layer H1 mainly containing red blood cells and a light layer L1 containing white blood cells and platelets in the centrifugation process.
  • a heavy layer H1 mainly containing red blood cells
  • a light layer L1 containing white blood cells and platelets in the centrifugation process.
  • red blood cells about 1.102 g / ml
  • white blood cells 1.064 to 1.097 g / ml
  • the density of platelets (1.03 to 1.04 g / ml)
  • the density of plasma (1.03 to 1.04 g / ml). This is because it is larger than 1.025 to 1.029 g / ml).
  • the blood contained in the first syringe cylinder 11 is separated into a heavy layer H1 mainly containing red blood cells, an intermediate layer M1 containing PRP, and a light layer L1 (PPP layer) in the centrifugation process. It may be good (see FIG. 15).
  • the specific gravity is intended to be the ratio between the density of the object (for example, red blood cells, white blood cells, platelets, and buoyancy 50, etc.) and the density of the standard substance (for example, distilled water at 4 degrees Celsius).
  • density is intended to be mass per unit volume. The density may be determined by, for example, an immersion method using a pycnometer (ISO 1183-1: 2019).
  • ISO 1183-1 an immersion method using a pycnometer
  • the first port 13 has a tubular shape.
  • the internal space of the first port 13 communicates with the internal space of the first syringe cylinder 11.
  • the first port 13 can function as a blood collection tube for accommodating a liquid in the first syringe cylinder 11 and a mounting portion for attaching an injection needle (for example, a blood collection needle, a bone marrow needle, etc.) and the like. good.
  • the inner surface of the first port 13 may be formed with a female screw screwed with a male screw formed in a blood collection tube (not shown) for collecting blood or bone marrow fluid.
  • the female screw formed on the inner surface of the first port 13 may be the same as the female screw 231 formed on the inner surface of the second port 23 described later (see FIG. 11).
  • the first gasket 14 is located in the first syringe cylinder 11 and is reciprocated in the first syringe cylinder 11.
  • the first gasket 14 is formed with a first mounting hole 141 to which the first plunger 12 can be mounted.
  • the reciprocating movement of the first gasket 14 in the first syringe cylinder 11 may be performed, for example, via the first plunger 12.
  • the liquid By reciprocating the first gasket 14, the liquid can be introduced into or discharged from the first syringe cylinder 11.
  • the preparation kit 110 may include a first cap 16 that can be liquid-tightly attached to the first port 13.
  • the first cap 16 is attached to the first port 13, for example, when the first syringe cylinder 11 is used as a centrifuge container.
  • the first syringe cylinder 11 can also function as a centrifuge container by attaching the first cap 16 to the first port 13. If the first cap 16 is used, the liquid can be centrifuged while the liquid is contained in the first syringe cylinder 11, or the liquid can be centrifuged with the first plunger 12 or the like attached to the first mounting hole 141. It is possible to perform separation processing.
  • the second syringe 20 may include a second gasket 24 that can be located within the second syringe cylinder 21. Further, the second syringe 20 may include a second plunger 22 that is detachably provided on the second gasket 24.
  • the second syringe cylinder 21 can store the contained liquid.
  • the second syringe cylinder 21 together with the second gasket 24 constitutes at least a part of the second syringe 20.
  • a second port 23 (second tip portion) is arranged at one end of the second syringe cylinder 21.
  • the portion of the second syringe cylinder 21 for storing the liquid may have a substantially tubular shape.
  • the liquid contained and stored in the second syringe cylinder 21 may be a part of the liquid stored in the first syringe cylinder 11.
  • the second syringe cylinder 21 can be used as a centrifuge container.
  • a heavy layer H2 having a high platelet concentration (that is, containing PRP) and a light layer L2 having a low platelet concentration (that is, containing PRP) are subjected to centrifugation. That is, it can be fractionated into platelets (hereinafter referred to as PPP) (see FIG. 18 and the like).
  • the concentration of each blood component when the concentration of each blood component is described as high or low without specifying a comparison target, it means that the concentration of each blood component is high or low as compared with whole blood.
  • the statement "high platelet concentration” means that the platelet concentration is high compared to whole blood
  • the statement "low platelet concentration” means that the platelet concentration is high compared to whole blood. It means low.
  • PRP means a liquid having a higher concentration of platelets as compared to whole blood.
  • PRP may mean a liquid having a higher concentration of growth factors released from platelets as compared to whole blood.
  • each blood component in the liquid for example, the number of predetermined components per unit volume (pieces / ⁇ L) can be used.
  • Each blood component in the liquid may be measured by, for example, an electric resistance method or a flow cytometry method.
  • the second port 23 has a tubular shape.
  • the internal space of the second port 23 communicates with the internal space of the second syringe cylinder 21.
  • the second port 23 functions as a mounting portion for mounting a member (for example, a tube, an injection needle, etc.) for accommodating the liquid in the second syringe cylinder 21 and discharging the liquid from the inside of the second syringe cylinder 21.
  • a member for example, a tube, an injection needle, etc.
  • the second port 23 may have the same structure as the first port 13. That is, a female screw 231 screwed with the male screw of the injection needle may be formed on the inner surface of the second port (see FIG. 11).
  • the male screw and the female screw 231 of the injection needle may be screwed by a luer lock type (ISO80369-7: 2016).
  • the second gasket 24 is located in the second syringe cylinder 21 and is reciprocated in the second syringe cylinder 21.
  • the second gasket 24 may be formed with a second mounting hole (not shown) to which the second plunger 22 can be mounted.
  • the reciprocating movement of the second gasket 24 in the second syringe cylinder 21 may be performed, for example, via the second plunger 22.
  • the liquid By reciprocating the second gasket 24, the liquid can be introduced into or discharged from the second syringe cylinder 21.
  • the preparation kit 110 may include a second cap 26 that can be liquid-tightly attached to the second port 23.
  • the second cap 26 is attached to the second port 23, for example, when the second syringe cylinder 21 is used as a centrifuge container.
  • the second cap 26 it is possible to perform the centrifugal separation treatment of the liquid while the liquid is contained in the second syringe cylinder 21.
  • the first needle 90 has a tubular shape having a first end 91 that can be inserted into a first gasket 14 that can be located in the first syringe cylinder 11 and a second end 92 that is located on the opposite side of the first end 91. It is a needle.
  • the first needle 90 may be connectable to the second port 23 of the second syringe cylinder 21.
  • the second end 92 of the first needle 90 is connected to the second port 23 and the first end 91 of the first needle 90 is passed through the first gasket 14 located in the first syringe cylinder 11, the second syringe 20 Can be connected to the first gasket 14 via the first needle 90.
  • the first needle 90 may be used to move a part of the liquid (for example, the light layer L1) in the first syringe cylinder 11 into the second syringe cylinder 21.
  • the preparation kit 110 may further include a first needle guide 96 used when the first end 91 of the first needle 90 is passed through the first gasket 14 (see FIG. 15).
  • the first needle guide 96 has a first guide hole, which is a through hole through which the first end 91 of the first needle 90 can move toward the first gasket 14.
  • the first end 91 of the first needle 90 moves in the first guide hole and reaches the first gasket 14.
  • the first end 91 that has passed through the first guide hole penetrates the first gasket 14 and reaches the internal space inside the first syringe cylinder 11 (see FIG. 15 and the like).
  • the buoy 50 may include at least one of a first buoy 51 located in the first syringe cylinder 11 and a second buoy 52 located in the second syringe cylinder 21.
  • the first buoy 51 is a buoy for the liquid in the first syringe cylinder 11. That is, the first buoy 51 is a sign located at the boundary between the two or more layers when the liquid in the first syringe cylinder 11 is divided into two or more layers.
  • the second buoy 52 is a buoy for the liquid in the second syringe barrel 21.
  • the second buoy 52 is a sign located at the boundary between the two or more layers when the liquid in the second syringe cylinder 21 is divided into two or more layers.
  • the first floating marker 51 may be a floating marker located at the boundary between the heavy layer H1 and the light layer L1 when the liquid in the first syringe cylinder 11 is fractionated.
  • the first buoy 51 has a specific density smaller than the specific density of the heavy layer H1 when the liquid in the first syringe cylinder 11 is fractionated, and the liquid in the first syringe cylinder 11 is fractionated. It may have a specific density larger than that of the light layer L1.
  • the second buoy 52 may be a buoy located at the boundary between the heavy layer H2 and the light layer L2 when the liquid in the second syringe cylinder 21 is fractionated.
  • the second buoy 52 has a specific density smaller than the specific density of the heavy layer H2 when the liquid in the second syringe cylinder 21 is fractionated, and the liquid in the second syringe cylinder 21 is fractionated. It may have a specific density larger than the specific gravity of the light layer L2.
  • the first buoy 51 when the liquid and the first buoy 51 are housed in the first syringe cylinder 11 and the liquid is fractionated into a heavy layer H1 having a large specific density and a light layer L1 having a small specific density, the first buoy is used. 51 may be located at the boundary between the heavy layer H1 and the light layer L1.
  • the second buoy 52 when the liquid and the second buoy 52 are housed in the second syringe cylinder 21, when the liquid is divided into a heavy layer having a large specific density and a light layer having a small specific density, the second buoy 52 is used. It may be located at the boundary between the heavy layer H2 and the light layer L2.
  • FIG. 1 shows a syringe system 100 including a buoy 50 including a first buoy 51 and a second buoy 52, but is not limited to this configuration. That is, the float 50 of the syringe system 100 may have only the second float 52 or only the first float 51.
  • buoy 50 when each buoy such as the first buoy 51 and the second buoy 52 is not distinguished, these buoys may be intentionally referred to as buoy 50.
  • the buoy 50 is intended, in one example, the first buoy 51 and / or the second buoy 52.
  • the buoy 50 is a buoy having a predetermined specific gravity.
  • the buoy 50 may have two or more buoy members having different specific densities.
  • the floating mark 50 is not limited to this, but is made of polystyrene, polypropylene, polyethylene, silicone, acrylic resin, acrylonitrile-butadiene-styrene resin (ABS), acrylonitrile-styrene resin (AS), and the like. And at least one of these combinations may have a floating member.
  • FIG. 2 is a cross-sectional view showing an example of a first buoy 51 and a second buoy 52 having a plurality of buoy members.
  • the first buoy 51 may be created by stacking the first buoy member 511 and the second buoy member 512 having different specific densities in a layered manner.
  • the first buoy member 511 and the second buoy member 512 may be stacked in layers by laminating them.
  • the first buoy member 511 may be made of silicone and the second buoy member 512 may be made of polystyrene.
  • the second buoy 52 may be created by laminating the third buoy member 521 and the fourth buoy member 522 having different specific gravities from each other in a layered manner.
  • the third buoy member 521 may be made of ABS and the second buoy member 512 may be made of silicone.
  • FIG. 2 shows an example of a first buoy 51 and a second buoy 52 having two buoy members, but the present invention is not limited thereto.
  • the first buoy 51 and the second buoy 52 may have a single buoy member or may have three or more buoy members.
  • the first buoy 51 and the second buoy 52 can be created so as to have a predetermined specific weight.
  • the first buoy 51 and the second buoy 52 may have a plurality of layers of buoy members, as shown in FIG.
  • the first buoy 51 and the second buoy 52 shown in FIG. 2 are merely examples, and the first buoy 51 and the second buoy having a desired specific density can be obtained by arbitrarily combining one or a plurality of buoy members having different specific densities. 2 Buoy 52 can be realized.
  • 1st Centrifugal Separation Treatment Using the 1st syringe cylinder 11 as a centrifuge container, the whole blood contained in the 1st syringe cylinder 11 is fractionated into the heavy layer H1 and the light layer L1 by centrifugal force. , A process of separating the light layer L1 by moving it into the second syringe cylinder 21 or the like (see FIG. 16 or the like).
  • Second centrifuge treatment Using the second syringe cylinder 21 as a centrifuge container, the light layer L1 separated by the first centrifugation treatment contained in the second syringe cylinder 21 is replaced with the heavy layer H2 (PRP.
  • the first buoy 51 may have a higher specific density than the specific density of human whole blood (1.052 to 1.060 for males and 1.049 to 1.056 for females). For example, it may have a specific density greater than 1.049 g / ml and may have a specific density greater than 1.052 g / ml.
  • the first buoy 51 may have a density between the density of red blood cells (about 1.102 g / ml) and the density of white blood cells (1.064 to 1.097 g / ml).
  • the density of the first buoy 51 may be 1.07 to 1.10 g / ml or 1.09 g / ml.
  • the first buoy 51 having such a density is located at the boundary between the heavy layer H1 and the light layer L1 in the first syringe cylinder 11 after the first centrifugation treatment. Therefore, the liquid of the light layer L1 can be selectively contained in the second syringe cylinder 21 while reducing the contamination of red blood cells.
  • the mass per unit volume of the second buoy 52 may be less than or equal to the mass per unit volume of the first buoy 51.
  • the second buoy 52 may have a density between the platelet density (1.03 to 1.04 g / ml) and the plasma density (1.025 to 1.029 g / ml).
  • the density of the second buoy 52 may be 1.026 to 1.05 g / ml or 1.03 g / ml.
  • the second buoy 52 having such a density is located at the boundary between the heavy layer H2 and the light layer L2 in the second syringe cylinder 21 when fractionation is performed in the second centrifugation treatment. Therefore, the heavy layer H2 containing PRP can be selectively collected while reducing plasma contamination.
  • the second buoy 52 has a specific gravity between the white blood cell density (1.064 to 1.097 g / ml) and the platelet density (1.03 to 1.04 g / ml). May be good.
  • the density of the second buoy 52 may be 1.04 to 1.08 g / ml or 1.05 g / ml.
  • the second buoy 52 having such a density is located at the boundary between the heavy layer H2 and the light layer L2 in the second syringe cylinder 21 after the second centrifugation treatment. Therefore, the light layer L2 containing PRP can be selectively collected while reducing leukocyte contamination.
  • the buoy 50 may have any of a through hole, a mesh portion, and a non-woven fabric-like portion at least in one place.
  • a through hole, a net-like portion, and a non-woven fabric-like portion may be provided in the central portion of the buoy 50.
  • the entire buoy 50 may be a net-like portion and a non-woven fabric-like portion.
  • the non-woven fabric is a cloth made by mechanically, chemically, and thermally treating a fiber sheet (web) and joining them with an adhesive or the fusion force of the fiber itself.
  • the non-woven portion may be a portion in which the structure of the non-woven fabric is realized by using the above-mentioned floating marker member or the like.
  • the buoy 50 is a movement of each component of the liquid in the first syringe cylinder 11 in the first centrifugation treatment, and each component of the liquid in the second syringe cylinder 21 in the second centrifugation treatment. It can be done so as not to interfere with the movement.
  • FIGS. 3 to 5 are diagrams showing an example of the shape of the buoy 50, respectively.
  • 3 to 5 are views for showing the shape of the buoy 50, and the size of each of the illustrated members is not accurate.
  • the illustrated buoy 50 when the illustrated buoy 50 is the first buoy 51, it is assumed that the first syringe cylinder 11 and the first gasket 14 are illustrated.
  • the illustrated buoy 50 when the illustrated buoy 50 is the second buoy 52, it is assumed that the second syringe cylinder 21 and the second gasket 24 are illustrated.
  • FIGS. 3 to 5 on the left side, a first syringe cylinder 11 (or a second syringe cylinder 21) and a first buoy 51 (or a second buoy 52) in a state where no liquid is contained are shown.
  • the first buoy 51 (or the second buoy 52) in a state where the liquid in the first syringe cylinder 11 (or the second syringe cylinder 21) is fractionated by the centrifugation process is shown.
  • At least one of the first floating mark 51 and the second floating mark 52 has a substantially circular flat plate shape, a disk shape having a conical surface whose central portion protrudes from the peripheral portion, or a disk shape whose central portion protrudes from the peripheral portion. It may have a disk shape having a curved surface.
  • FIG. 3 shows an example of a buoy 50 having a substantially circular flat plate shape.
  • FIG. 4 shows an example of a buoy 50 having a disk shape having a conical surface whose central portion protrudes from the peripheral portion.
  • FIG. 5 shows an example of a buoy 50 having a disk shape having a curved surface whose central portion protrudes from the peripheral portion.
  • the diameter of the first buoy 51 is preferably smaller than the inner diameter of the first syringe cylinder 11, and the diameter of the second buoy 52 may be smaller than the inner diameter of the second syringe cylinder 21.
  • the first buoy 51 and the second buoy 52 can easily move smoothly in the first syringe cylinder 11 and the second syringe cylinder 21, respectively.
  • this is not limited as long as the first buoy 51 and the second buoy 52 can move smoothly in the first syringe cylinder 11 and the second syringe cylinder 21, respectively.
  • the buoy 50 has a first point P1 at an arbitrary position on the lower surface and a second point P2 at an arbitrary position on the upper surface.
  • the length of at least one of the straight lines connecting the first point P1 and the second point P2 of the first buoy 51 may be larger than the inner diameter of the first syringe cylinder 11.
  • the length of at least one of the straight lines connecting the first point P1 and the second point P2 of the second buoy 52 may be larger than the inner diameter of the second syringe cylinder 21.
  • the lower surface of the first buoy 51 is a surface facing the bottom surface 111 of the first syringe cylinder 11
  • the upper surface of the first buoy 51 is a surface opposite to the lower surface of the first buoy 51.
  • the bottom surface 111 of the first syringe cylinder 11 is the innermost surface in the first syringe cylinder 11, and in one example, the communication hole between the internal space of the first syringe cylinder 11 and the internal space of the first port 13 is provided. It is a provided surface.
  • the upper surface of the second buoy 52 is the surface opposite to the lower surface of the second buoy 52.
  • the bottom surface 211 of the second syringe cylinder 21 is the innermost surface in the second syringe cylinder 21, and in one example, the communication hole between the internal space of the second syringe cylinder 21 and the internal space of the second port 23 is provided. It is a provided surface.
  • the buoy 50 may have flexibility.
  • the first gasket 14 in a state where no liquid is contained in the first syringe cylinder 11 and the first gasket 14 is pushed into the innermost part in the first syringe cylinder 11, the first gasket 14 has a first gasket 14. It is sandwiched between the lower surface 143 and the bottom surface 111 in the first syringe cylinder 11.
  • the first buoy 51 can be deformed according to the shape of the gap between the lower surface 143 of the first gasket 14 and the bottom surface 111 in the first syringe cylinder 11 as shown in FIGS. 3 to 5. You may.
  • the lower surface 143 of the first gasket 14 is a surface opposite to the surface on which the first plunger 12 is attached, and is a surface facing the bottom surface 111 in the first syringe cylinder 11.
  • the bottom surface 111 in the first syringe cylinder 11 is the innermost surface in the first syringe cylinder 11, and in one example, the internal space of the first syringe cylinder 11 and the internal space of the first port 13 This is a surface provided with a communication hole.
  • the air in the gap between the lower surface 143 of the first gasket 14 and the bottom surface 111 of the first syringe cylinder 11 is the first syringe together with the liquid. It is housed in the cylinder 11.
  • the upper limit of the volume of the liquid that can be contained in the first syringe cylinder 11 can be lowered. If the first buoy 51 can be deformed according to the shape of the gap between the lower surface 143 of the first gasket 14 and the bottom surface 111 in the first syringe cylinder 11, it is housed in the first syringe cylinder 11 together with the liquid. It is possible to reduce the amount of air.
  • the second buoy 52 may also have flexibility like the first buoy 51.
  • the second buoy 52 has a second gasket 24 in a state where no liquid is contained in the second syringe cylinder 21 and the second gasket 24 is pushed into the innermost part of the second syringe cylinder 21. It is sandwiched between the lower surface 243 and the bottom surface of the second syringe cylinder 21.
  • the second buoy 52 can be deformed according to the shape of the gap between the lower surface 243 of the second gasket 24 and the bottom surface 211 in the second syringe cylinder 21 as shown in FIGS. 3 to 5. You may.
  • the lower surface 243 of the second gasket 24 is a surface opposite to the surface on which the second plunger 22 is attached, and is a surface facing the bottom surface 211 in the second syringe cylinder 21.
  • the bottom surface 211 in the second syringe cylinder 21 is the innermost surface in the second syringe cylinder 21, and in one example, the internal space of the second syringe cylinder 21 and the internal space of the second port 23. This is a surface provided with a communication hole.
  • the second buoy 52 can be deformed according to the shape of the gap between the lower surface 243 of the second gasket 24 and the bottom surface 211 in the second syringe cylinder 21, it is housed in the second syringe cylinder 21 together with the liquid. It is possible to reduce the amount of air.
  • the first buoy 51 is from the inside of the first syringe cylinder 11 to the inside of the second syringe cylinder 21 when a part of the liquid in the first syringe cylinder 11 (for example, the light layer L1) is moved into the second syringe cylinder 21. It may function as a lid that blocks the movement of liquid to. In this case, the first buoy 51 may have a first covering portion capable of covering at least a part of the first gasket 14. The shape of the first buoy 51 will be described with reference to FIG. FIG. 6 is a diagram showing an example of the shape of the first buoy 51 that can function as a lid that blocks the movement of the liquid.
  • the bottom surface 111 in the first syringe cylinder 11 may have a tapered shape in which the inner diameter decreases toward the first port 13 side.
  • the lower surface 143 of the first gasket 14 has an apex portion 1431 most protruding into the internal space in the first syringe cylinder 11 and a peripheral edge portion 1432 surrounding the apex portion 1431, and is directed from the peripheral edge portion 1432 toward the apex portion 1431. Therefore, it may have a tapered shape in which the outer diameter becomes smaller.
  • the lower surface 143 of the first gasket 14 may be a conical surface as shown in FIG.
  • the angle at the apex of the conical surface of the upper surface 514 of the first levitation 51 is defined as ⁇ b. If so, ⁇ b may be smaller than ⁇ g, which is the angle of the apex portion 1431 of the lower surface 143 of the first gasket 14.
  • the first buoy 51 gradually becomes the first gasket 14 while the liquid of the light layer L1 in the first syringe cylinder 11 is accommodated in the second syringe cylinder 21. Get closer.
  • the peripheral edge of the upper surface 514 of the first buoy 51 comes into contact with the lower surface 143 of the first gasket 14, and the liquid of the heavy layer H1 is the first buoy. It becomes difficult to move into the second syringe cylinder 21 because it is blocked by the 51.
  • the first buoy 51 can function as a lid for blocking the movement of the liquid from the inside of the first syringe cylinder 11 to the inside of the second syringe cylinder 21. Therefore, if the syringe system 100 is used, the liquid of the light layer L1 in the first syringe cylinder 11 can be selectively moved into the second syringe cylinder 21.
  • the entire first buoy 51 functions as the first covering portion.
  • the present invention is not limited to this, and a portion of the first buoy 51 corresponding to the flow path provided in the first gasket 14 (for example, a central portion or the like) may function as the first covering portion.
  • the first buoy 51 is a first syringe cylinder when a part of the liquid in the first syringe cylinder 11 (for example, the heavy layer H1) is moved out of the first syringe cylinder 11 through the first port 13.
  • 11 It may function as a lid that blocks the movement of the liquid from the inside to the outside.
  • the first buoy 51 may include a first covering portion that closes the first port 13.
  • FIG. 7 is a diagram showing an example of the shape of the first buoy 51 that can function as a lid that blocks the movement of the liquid.
  • the upper surface 514 of the first buoy 51 may be provided with a recess 513. ..
  • the structure may be such that the opening of the recess 513 of the first buoy 51 abuts on the lower surface 143 of the first gasket 14.
  • the first buoy 51 gradually approaches the first gasket 14 while the liquid of the light layer L1 in the first syringe cylinder 11 is accommodated in the second syringe cylinder 21. ..
  • the upper surface 514 of the first buoy 51 comes into contact with the lower surface 143 of the first gasket 14.
  • the recess 513 covers the first end 91 of the first needle 90, it becomes difficult for the liquid of the heavy layer H1 to move into the second syringe cylinder 21.
  • the first buoy 51 can function as a lid for blocking the movement of the liquid from the inside of the first syringe cylinder 11 to the inside of the second syringe cylinder 21. Therefore, if the syringe system 100 is used, the liquid of the light layer L1 in the first syringe cylinder 11 can be selectively moved into the second syringe cylinder 21.
  • the first buoy 51 has a shape as shown in FIG. 7, for example, the recess 513 of the first buoy 51 functions as the first covering portion.
  • the second buoy 52 is a third syringe cylinder from the inside of the second syringe cylinder 21 when a part of the liquid (for example, the light layer L2) in the second syringe cylinder 21 is moved into the third syringe cylinder 31 described later. It may function as a lid that blocks the movement of the liquid into the 31.
  • the second buoy 52 may have a second covering portion capable of covering at least a part of the second gasket 24.
  • the second buoy 52 may have a shape as shown in FIGS. 6 and 7, similarly to the first buoy. That is, the second buoy 52 may have a disk shape having a conical surface whose central portion protrudes from the peripheral edge portion, or the upper surface of the second buoy 52 may be provided with a recess such as a recess 513. good.
  • the entire second buoy 52 functions as the second covering portion.
  • the present invention is not limited to this, and the portion (for example, the central portion) of the second buoy 52 corresponding to the flow path provided in the second gasket 24 may function as the second covering portion.
  • the recess of the second buoy 52 may function as the second covering portion.
  • the second buoy 52 moves from the inside to the outside of the second syringe cylinder 21 when a part of the liquid in the second syringe cylinder 21 (for example, the heavy layer H2) is moved to the outside of the second syringe cylinder 21. It may function as a lid that blocks the movement of the liquid (see FIG. 16).
  • the second floating mark 52 may include a second covering portion that closes the second port 23.
  • the second buoy 52 may include two buoys having different masses per unit volume.
  • FIG. 8 is a diagram showing a configuration example of a preparation kit 110a including a syringe system 100a having a second buoy 52 including two buoys.
  • the second buoy 52 of the syringe system 100a includes two buoys having different masses per unit volume.
  • the syringe system 100a shown in FIG. 8 includes a buoy 52a having a specific density Y and a buoy 52b having a specific density Z different from the specific density Y. Both the buoy 52a and the buoy 52b can be located in the second syringe barrel 21.
  • the buoy 52a having a specific gravity larger than that of the buoy 52b is located closer to the second port 23 than the buoy 52b. You may.
  • the liquid in the second syringe cylinder 21 is divided into a heavy layer H2 having a large specific density, a light layer L2 having a small specific gravity, and an intermediate layer M2 having an intermediate specific gravity between the heavy layer H2 and the light layer L2.
  • the floating mark 52a may be located at the boundary between the heavy layer H2 and the intermediate layer M2
  • the floating mark 52b may be located at the boundary between the intermediate layer M2 and the light layer L2 (see FIG. 18 and the like).
  • the first buoy 51 may include two buoys having different masses per unit volume.
  • FIG. 9 is a diagram showing a configuration example of a preparation kit 110b including a syringe system 100b having a first buoy 51 including two buoys.
  • the first buoy 51 of the syringe system 100b includes a buoy 51a having a specific density P and a buoy 51b having a specific density Q different from the specific density P. Both the buoy 51a and the buoy 51b can be located in the first syringe barrel 11.
  • the buoy 51a having a specific gravity larger than that of the buoy 51b is located closer to the first port 13 than the buoy 51b. You may.
  • the liquid in the first syringe cylinder 11 is fractionated into a heavy layer H1 having a large specific density, a light layer L1 having a small specific gravity, and an intermediate layer M1 having an intermediate specific gravity between the heavy layer H1 and the light layer L1.
  • the floating mark 51a may be located at the boundary between the heavy layer H1 and the intermediate layer M1
  • the floating mark 51b may be located at the boundary between the intermediate layer M1 and the light layer L1 (see FIG. 15).
  • the buoy 51a may have a specific gravity between the density of red blood cells (about 1.102 g / ml) and the density of white blood cells (1.064 to 1.097 g / ml).
  • the density of the buoy 51a may be 1.07 to 1.10 g / ml or 1.09 g / ml.
  • the buoy 51a having such a density is located at the boundary between the heavy layer H1 and the intermediate layer M1 in the first syringe cylinder 11 after the centrifugation treatment.
  • the buoy 51b may have a density between the density of platelets (1.03 to 1.04 g / ml) and the density of plasma (1.025 to 1.029 g / ml). ..
  • the density of the buoy 51b may be 1.026 to 1.05 g / ml or 1.03 g / ml.
  • the buoy 51b having such a density is located at the boundary between the intermediate layer M1 and the light layer L1 in the first syringe cylinder 11 when fractionation is performed in the centrifugation process (see FIG. 15).
  • the syringe system 100b shown in FIG. 9 has only, but is not limited to, a first buoy 51 containing two buoys having different specific densities.
  • the buoy 50b may further have a second buoy 52.
  • the second syringe 20 may have a second port 23 (second tip portion) connectable to the first gasket 14, and may be movably connected to the first syringe 10 and the first syringe cylinder 11. In this case, at least a part of the liquid in the first syringe cylinder 11 is movable in the second syringe cylinder 21. According to this configuration, it is possible to move the liquid in the first syringe cylinder 11 into the second syringe cylinder 21 without using the first needle 90.
  • FIG. 10 is a diagram showing a configuration example of a preparation kit 110c including a syringe system 100c in which the second syringe 20 can be connected to the first gasket 14.
  • the syringe system 100c shown in FIG. 10 has one first buoy 51 and one second buoy 52, but is not limited thereto.
  • the buoy 50 may have only one of the first buoy 51 and the second buoy 52, or the first buoy 51 and the second buoy 52 may have a plurality of buoys.
  • the first gasket 14 of the first syringe 10 included in the syringe system 100c is formed with a first mounting hole 141 to which the first plunger 12 can be mounted. It is also possible to mount the second port 23 of the second syringe cylinder 21 in the first mounting hole 141.
  • the structure of the first gasket 14 and the second port 23 will be described with reference to FIG.
  • FIG. 11 is a diagram showing an example of a structure adopted for connecting the first mounting hole 141 and the second port 23.
  • a female screw 142 screwed with a male screw 232 formed on the outer surface of the second port 23 may be formed on the inner surface of the first mounting hole 141.
  • the first gasket 14 and the second syringe cylinder 21 can be liquid-tightly connected.
  • the first mounting hole 141 does not have to penetrate inside and outside the first syringe cylinder 11.
  • the first mounting hole 141 may penetrate the inside and outside of the first syringe cylinder 11. Even when the first mounting hole 141 penetrates inside and outside the first syringe cylinder 11, the second port 23 of the second syringe cylinder 21 in which the second gasket 24 is inserted in the first mounting hole 141 is inserted.
  • the first cap 16 By attaching and attaching the first cap 16 to the first port 13, the inside of the first syringe cylinder 11 can be sealed.
  • the outer diameter of at least a part of the second syringe cylinder 21 may be smaller than the inner diameter of the first syringe cylinder 11. At least a portion of the second syringe 20 can be located within the first syringe barrel 11. The internal volume of the second syringe cylinder 21 may be smaller than the internal volume of the first syringe cylinder 11.
  • FIG. 12 is a diagram showing a configuration example of a preparation kit 110d including the syringe system 100d according to the second embodiment of the present disclosure.
  • the syringe system 100d further includes a third syringe 30 having a third syringe cylinder 31 capable of storing liquid.
  • FIG. 12 shows a syringe system 100d further comprising a second needle 93, but the second needle 93 is not an essential configuration of the syringe system 100d.
  • the third syringe 30 may include a third gasket 34 that can be located within the third syringe cylinder 31. Further, the third syringe 30 may include a third plunger 32 that is detachably provided on the third gasket 34.
  • the third syringe cylinder 31 can store the contained liquid.
  • the third syringe cylinder 31 together with the third gasket 34 constitutes at least a part of the third syringe 30.
  • a third port 33 (third tip portion) is arranged at one end of the third syringe cylinder 31.
  • the portion of the third syringe cylinder 31 that stores the liquid may have a substantially tubular shape.
  • the liquid stored in the third syringe cylinder 31 may be a part of the liquid in the second syringe cylinder 21 separated by the second centrifugation treatment.
  • the liquid stored in the third syringe cylinder 31 may be PRP, PPP, or the like.
  • the preparation kit 110d may include a third cap 36 that can be liquid-tightly attached to the third port 33.
  • the third cap 36 is attached to the third port 33, for example, when the third syringe cylinder 31 is used as a centrifuge container.
  • the third syringe cylinder 31 can also function as a centrifuge container by attaching the third cap 36 to the third port 33.
  • the third cap 36 it is possible to perform the centrifugal separation treatment (the third centrifugal separation treatment described later) of the liquid while the liquid is contained in the third syringe cylinder 31.
  • the second needle 93 has a tubular shape having a third end 95 capable of penetrating a second gasket 24 located in the second syringe cylinder 21 and a fourth end 94 located on the opposite side of the third end 95. It is a needle.
  • the second needle 93 may be connectable to the third port 33 of the third syringe cylinder 31.
  • the fourth end 94 of the second needle 93 is connected to the third port 33 and the third end 95 of the second needle 93 is passed through the second gasket 24 located in the second syringe cylinder 21, the third syringe 30 can be connected to the inside of the second syringe cylinder 21 via the second needle 93.
  • the preparation kit 110d may further include a second needle guide 97 used when the third end 95 of the second needle 93 is passed through the second gasket 24.
  • the second needle guide 97 has a second guide hole, which is a through hole through which the third end 95 of the second needle 93 can move toward the second gasket 24.
  • the third end 95 of the second needle 93 moves in the second guide hole and reaches the second gasket 24.
  • the third end 95 that has passed through the second guide hole penetrates the second gasket 24 and reaches the internal space inside the second syringe cylinder 21 (see FIG. 18 and the like).
  • the third syringe 30 may be movably connected to the second syringe 20 from inside the second syringe cylinder 21.
  • the second syringe 20 and the third syringe 30 can move the liquid from the inside of the second syringe cylinder 21 into the third syringe cylinder 31.
  • the second needle 93 may be used to move a part of the liquid in the second syringe cylinder 21 (for example, the light layer L2 or the intermediate layer M2) into the third syringe cylinder 31.
  • FIG. 13 is a diagram showing a configuration example of a preparation kit 110e including a syringe system 100e in which the third syringe 30 can be connected to the second gasket 24.
  • the syringe system 100e shown in FIG. 13 has a second buoy 52 containing two buoys having different specific densities, but is not limited thereto.
  • the buoy 50a may have only one of the first buoy 51 and the second buoy 52, or may have one first buoy 51 and one second buoy 52.
  • the second gasket 24 of the second syringe 20 included in the syringe system 100e is formed with a second mounting hole 241 to which the second plunger 22 can be mounted. It is also possible to mount the third port 33 of the third syringe cylinder 31 in the second mounting hole 241.
  • the structure adopted for connecting the second mounting hole 241 and the third port 33 may be, for example, the same as that shown in FIG.
  • the second mounting hole 241 does not have to penetrate inside and outside the second syringe cylinder 21.
  • the second mounting hole 241 may penetrate inside and outside the second syringe cylinder 21 in the same manner as the first mounting hole 141 (see FIG. 11). Even when the second mounting hole 241 penetrates inside and outside the second syringe cylinder 21, the second plunger 22, the third port 33, or the like is mounted in the second mounting hole 241 and the second port 23 is attached. If the second cap 26 is attached to the second syringe cylinder 21, the inside of the second syringe cylinder 21 can be sealed.
  • the outer diameter of at least a part of the third syringe cylinder 31 may be smaller than the inner diameter of the second syringe cylinder 21. At least a portion of the third syringe 30 can be located within the second syringe barrel 21.
  • the internal volume of the third syringe cylinder 31 may be smaller than the internal volume of the second syringe cylinder 21.
  • the buoy 50 may have at least one third buoy 53 located in the third syringe cylinder 31.
  • the third buoy is a buoy for the liquid stored in the third syringe cylinder 31.
  • FIG. 14 is a diagram showing a configuration example of a preparation kit 110f including a syringe system 100f having a third buoy 53.
  • the buoy 50c of the syringe system 100f further has a third buoy 53 in addition to the first buoy 51 and the second buoy 52.
  • the second buoy 52 includes a buoy 52a having a specific density Y and a buoy 52b having a specific density Z different from the specific density Y.
  • the third buoy 53 can be located within the third syringe barrel 31.
  • the third buoy 53 is a buoy for the liquid in the third syringe cylinder 31. That is, the third buoy 53 is a sign located at the boundary between the two or more layers when the liquid in the third syringe cylinder 31 is divided into two or more layers. In other words, the third buoy 53 has a specific density smaller than the specific density of the heavy layer H3 when the liquid in the third syringe cylinder 31 is fractionated, and the liquid in the third syringe cylinder 31 is fractionated. It may have a specific density larger than that of the light layer L3.
  • the third buoy 53 may have two or more buoy members having different specific densities.
  • the third floating mark 53 is not limited to this, but is made of polystyrene, polypropylene, polyethylene, silicone, acrylic resin, acrylonitrile-butadiene-styrene resin (ABS), acrylonitrile-styrene resin (AS). It may have at least one of a floating member made of, and a combination thereof.
  • the third buoy 53 is located at the boundary between the heavy layer H3 and the light layer L3. It may be located (see FIG. 24 etc.).
  • a third centrifugation treatment may be performed.
  • PRP having a low white blood cell mixture amount can be prepared from whole blood.
  • 3rd Centrifugal Separation Treatment The heavy layer H2 (layer containing PRP) obtained by the second centrifugation treatment is fractionated into a heavy layer H3 and a light layer L3 by using centrifugal force, and the heavy layer H3 or A process for separating the light layer L3 by taking it out from the inside of the third syringe cylinder 31 (see FIG. 24 and the like).
  • the heavy layer H3 may be a layer having a higher concentration of leukocytes than the light layer L3.
  • the mass per unit volume of the third buoy 53 may be less than or equal to the mass per unit volume of the first buoy 51. Further, the mass per unit volume of the third buoy 53 may be equal to or less than the mass per unit volume of the second buoy 52 (for example, the buoy 52a).
  • the third buoy 53 either the liquid of the heavy layer H3 or the liquid of the light layer L3 can be used while reducing the mixing of the liquid of the heavy layer H3 containing white blood cells and the liquid of the light layer L3 containing platelets. It is possible to discharge from the third port 33.
  • the third buoy 53 may have any of a through hole, a net-like portion, and a non-woven fabric-like portion at least in one place. According to this configuration, the third buoy 53 can prevent the movement of each component of the liquid in the third syringe cylinder 31 in the third centrifugation process.
  • the third floating mark 53 has a substantially circular flat plate shape, a disk shape having a conical surface whose central portion protrudes from the peripheral edge portion, or a disk shape having a curved surface whose central portion protrudes from the peripheral edge portion. You may.
  • the diameter of the third buoy 53 may be smaller than the inner diameter of the third syringe cylinder 31. This facilitates the smooth movement of the third buoy 53 in the third syringe cylinder 31.
  • the present invention is not limited to this as long as the third floating mark 53 can move smoothly in the third syringe cylinder 31.
  • the third floating mark 53 has a first point P1 at an arbitrary position on the lower surface and a second point P2 at an arbitrary position on the upper surface.
  • the length of at least one of the straight lines connecting the first point P1 and the second point P2 of the third buoy 53 may be larger than the inner diameter of the third syringe cylinder 31.
  • the lower surface of the third floating marker 53 is a surface facing the lower surface of the third syringe cylinder 31.
  • the upper surface of the third buoy 53 is the surface opposite to the lower surface of the third buoy 53.
  • the third buoy 53 may have flexibility like the first buoy 51 and the second buoy 52.
  • the third buoy 53 is a third when a part of the liquid in the third syringe cylinder 31 (for example, the light layer L3) is moved from the third port 33 to the outside of the third syringe cylinder 31 through the third port 33. It may function as a lid that blocks the movement of the liquid from the inside of the syringe cylinder 31 to the outside. In this case, the third buoy 53 may include a third covering portion that closes the third port 33. The usage of the third buoy 53 will be described later (see FIG. 24).
  • Example 1 (Method for preparing PRP using preparation kit 110b) The process of preparing PRP using the preparation kit 110b will be described with reference to FIG.
  • FIG. 15 is a diagram showing a flow of processing for preparing PRP from blood using the preparation kit 110b shown in FIG.
  • the first plunger 12 is attached to the first gasket 14 located in the first syringe cylinder 11.
  • a first buoy 51 including a buoy 51a and a buoy 51b is located in the first syringe cylinder 11.
  • the buoy 51b has a through hole, and the buoy 51a does not have a through hole.
  • a levitation plate 51a having a specific density P smaller than the specific density of red blood cells and larger than the specific density of white blood cells is used
  • the buoyancy standard 51b a specific density Q smaller than the specific gravity of platelets and larger than the specific gravity of plasma is used. I am using the one that has.
  • the buoy 51b may have a net-like portion or a non-woven fabric-like portion instead of the through hole.
  • the first syringe cylinder 11 from which the first plunger 12 connected to the first gasket 14 has been removed is used as a centrifuge container, and the centrifugal force from the first gasket 14 side toward the first port 13 side is used for centrifugation. Will be.
  • the liquid in the first syringe cylinder 11 is fractionated into a heavy layer H1 containing red blood cells, an intermediate layer M1 containing PRP, and a light layer L1 (PPP layer).
  • the buoy 51a When a buoy 51a having a specific density smaller than that of the heavy layer H1 and larger than that of the intermediate layer M1 is used, the buoy 51a is located at the boundary between the heavy layer H1 and the intermediate layer M1. Further, when a buoy 51b having a specific density smaller than the specific gravity of the intermediate layer M1 and larger than the specific gravity of the light layer L1 is used, the buoy 51b is located at the boundary between the intermediate layer M1 and the light layer L1.
  • the second plunger 22 is pulled in the direction of pulling out the second gasket 24 from the inside of the second syringe cylinder 21.
  • the second gasket 24 moves, and the liquid of the intermediate layer M1 is accommodated in the second syringe cylinder 21.
  • the liquid of the heavy layer H1 mainly containing red blood cells and the light layer L1 (PPP layer) remain.
  • the step of moving the second gasket 24 in the direction of pulling out from the inside of the second syringe cylinder 21 may be completed when the buoy 51b comes into contact with the buoy 51a.
  • the liquid in the intermediate layer M1 in the first syringe cylinder 11 can be selectively moved into the second syringe cylinder 21.
  • the buoy 51b comes into contact with the buoy 51a, the buoy 51a may block the flow path of the liquid from the first needle 90 into the second syringe cylinder 21.
  • the liquid in the intermediate layer M1 in the first syringe cylinder 11 can be more selectively moved into the second syringe cylinder 21. That is, it is possible to reduce the possibility that the liquid of the heavy layer H1 (and the liquid of the light layer L1) in the first syringe cylinder 11 moves into the second syringe cylinder 21.
  • the liquid of the intermediate layer M1 containing PRP can be accommodated in the second syringe cylinder 21 by one centrifugation treatment.
  • the PRP can be administered to the affected part of the patient using the second syringe 20.
  • FIG. 16 is a diagram showing an example of a flow of processing for preparing PRP from blood using the preparation kit 110c shown in FIG.
  • the first buoy 51 is located in the first syringe cylinder 11
  • the second buoy 52 is located in the second syringe cylinder 21.
  • the first cap 16 is attached to the first port 13.
  • the first buoy 51 When the first buoy 51 comes into contact with the first gasket 14, the first buoy 51 is provided with a flow path of liquid into the second syringe cylinder 21 provided in the first gasket 14 (for example, the first mounting hole 141). ) May be closed. In this case, the liquid in the light layer L1 in the first syringe cylinder 11 can be more selectively moved into the second syringe cylinder 21. That is, the possibility that the liquid in the heavy layer H1 in the first syringe cylinder 11 moves into the second syringe cylinder 21 can be reduced.
  • the heavy layer H2 containing PRP can be administered from the inside of the second syringe cylinder 21 to the affected part of the patient.
  • the second plunger 22 is oriented in the direction of pushing the second gasket 24 into the second syringe cylinder 21.
  • the second gasket 24 moves, and the liquid of the heavy layer H2 moves from the inside of the second syringe cylinder 21 to the affected part of the patient.
  • the step of moving the second gasket 24 in the direction of pushing it into the second syringe cylinder 21 may be completed when the first buoy 51 comes into contact with the bottom surface (see FIGS.
  • the liquid of the heavy layer H2 in the second syringe cylinder 21 can be selectively transferred to the affected part of the patient.
  • the second buoy 52 may block the second port 23.
  • the liquid of the heavy layer H2 in the second syringe cylinder 21 can be more selectively transferred to the affected part of the patient. That is, it is possible to reduce the possibility that the liquid in the light layer L2 in the second syringe cylinder 21 will move to the affected part of the patient.
  • FIG. 17 is a diagram showing an example of the first half of the flow of processing for preparing PRP from blood using the preparation kit 110d shown in FIG.
  • FIG. 18 is a diagram showing an example of the latter half of the flow of processing for preparing PRP from blood using the preparation kit 110d shown in FIG.
  • the first syringe tube 11 is used as a centrifuge container, and the first centrifugal separation process is performed using the centrifugal force from the first gasket 14 side toward the first port 13 side.
  • blood is fractionated into, for example, a heavy layer H1 containing mainly red blood cells and a light layer L1 containing white blood cells and platelets.
  • the first buoy 51 having a lower specific density than the heavy layer H1 and a higher specific density than the light layer L1 is used, the first buoy 51 is the boundary portion between the heavy layer H1 and the light layer L1. Located in.
  • a second buoy 52 including a buoy 52a and a buoy 52b is located in the second syringe cylinder 21.
  • the buoy 52a has a through hole, and the buoy 52b does not have a through hole.
  • the buoyancy mark 52a one having a specific density Y smaller than the specific density of leukocytes such as neutrophils and basophils and larger than the specific density of platelets is used, and as the buoyancy mark 52b, it is smaller than the specific gravity of platelets. Those having a specific density Z larger than the specific density of plasma are used.
  • the buoy 52a may have a net-like portion or a non-woven fabric-like portion instead of the through hole.
  • the first end 91 of the first needle 90 is passed through the first gasket 14.
  • the first needle guide 96 having the first guide hole into which the first end 91 of the first needle 90 can be inserted may be used.
  • the first end 91 that has passed through the first guide hole penetrates the first gasket 14, and is a position in the internal space inside the first syringe cylinder 11 where the liquid of the light layer L1 in the first syringe cylinder 11 can be sucked. Has reached.
  • the second plunger 22 is pulled in the direction of pulling out the second gasket 24 from the inside of the second syringe cylinder 21.
  • the second gasket 24 moves, and the liquid of the light layer L1 is accommodated in the second syringe cylinder 21.
  • the step of moving the second gasket 24 in the direction of pulling out from the inside of the second syringe cylinder 21 may be completed when the first buoy 51 comes into contact with the first gasket 14. Thereby, the liquid of the light layer L1 in the first syringe cylinder 11 can be selectively moved into the second syringe cylinder 21.
  • the first buoy 51 When the first buoy 51 comes into contact with the first gasket 14, the first buoy 51 may block the flow path of the liquid from the first needle 90 into the second syringe cylinder 21. In this case, the liquid in the light layer L1 in the first syringe cylinder 11 can be more selectively moved into the second syringe cylinder 21. That is, the possibility that the liquid in the heavy layer H1 in the first syringe cylinder 11 moves into the second syringe cylinder 21 can be reduced.
  • the second syringe cylinder 21 is used as a centrifuge container, and the second centrifugation process is performed using the centrifugal force from the second gasket 24 side toward the second port 23 side.
  • the liquid in the second syringe cylinder 21 is fractionated into a heavy layer H2 containing leukocytes, an intermediate layer M2 containing PRP, and a light layer L2 (PPP layer).
  • a buoy 52a having a specific density smaller than that of the heavy layer H2 and larger than that of the intermediate layer M2 is used, the buoy 52a is located at the boundary between the heavy layer H2 and the intermediate layer M2.
  • a buoy 52b having a specific density smaller than the specific gravity of the intermediate layer M2 and larger than the specific gravity of the light layer L2 is used, the buoy 52b is located at the boundary between the intermediate layer M2 and the light layer L2.
  • the third plunger 32 is pulled in the direction of pulling out the third gasket 34 from the inside of the third syringe cylinder 31.
  • the third gasket 34 moves, and the liquid of the light layer L2 is accommodated in the third syringe cylinder 31.
  • the step of moving the third gasket 34 in the direction of pulling out from the inside of the third syringe cylinder 31 may be completed when the buoy 52b comes into contact with the second gasket 24.
  • the liquid of the light layer L2 in the second syringe cylinder 21 can be selectively moved into the third syringe cylinder 31.
  • the buoy 52b When the buoy 52b comes into contact with the second gasket 24, the buoy 52b may block the liquid flow path from the second needle 93 into the second syringe barrel 21. In this case, the liquid in the light layer L1 in the second syringe cylinder 21 can be more selectively moved into the third syringe cylinder 31. That is, it is possible to reduce the possibility that at least one of the liquid of the heavy layer H2 and the intermediate layer M2 in the second syringe cylinder 21 moves into the third syringe cylinder 31.
  • the buoy 52a has a through hole.
  • the liquid in the intermediate layer M2 can also be discharged from the second port 23.
  • an injection needle (not shown) may be attached to the second port 23 to administer PRP having a low leukocyte concentration to the affected area of the patient.
  • FIG. 19 is a diagram showing an example of the first half of the flow of processing for preparing PRP from blood using the preparation kit 110d shown in FIG.
  • FIG. 20 is a diagram showing an example of the latter half of the flow of processing for preparing PRP from blood using the preparation kit 110d shown in FIG.
  • the same reference numerals are added to the same states as those described in the above embodiment, and the description is not repeated.
  • a second buoy 52 including a buoy 52a and a buoy 52b is located in the second syringe cylinder 21.
  • the buoy 52a and the buoy 52b have through holes.
  • the buoyancy mark 52a one having a specific density Y smaller than the specific density of leukocytes such as neutrophils and basophils and larger than the specific density of platelets is used, and as the buoyancy mark 52b, it is smaller than the specific gravity of platelets. , Those having a specific density Z larger than the specific density of plasma are used.
  • the buoy 52a and the buoy 52b may have a net-like portion or a non-woven fabric-like portion instead of the through hole.
  • the state ⁇ 5c> shown in FIG. 20 is the same as the state ⁇ 5c> shown in FIG.
  • the second syringe cylinder 21 is used as a centrifuge container, and the second centrifugation process is performed using the centrifugal force from the second gasket 24 side toward the second port 23 side.
  • the liquid in the second syringe cylinder 21 is fractionated into a heavy layer H2 containing leukocytes, an intermediate layer M2 containing PRP, and a light layer L2 (PPP layer).
  • a buoy 52a having a specific density smaller than that of the heavy layer H2 and larger than that of the intermediate layer M2 is used, the buoy 52a is located at the boundary between the heavy layer H2 and the intermediate layer M2.
  • a buoy 52b having a specific density smaller than the specific gravity of the intermediate layer M2 and larger than the specific gravity of the light layer L2 is used, the buoy 52b is located at the boundary between the intermediate layer M2 and the light layer L2.
  • the third plunger 32 is pulled in the direction of pulling out the third gasket 34 from the inside of the third syringe cylinder 31.
  • the third gasket 34 moves, and the liquid of the intermediate layer M2 is accommodated in the third syringe cylinder 31.
  • the step of moving the third gasket 34 in the direction of pulling out from the inside of the third syringe cylinder 31 may be completed when the buoy 52b comes into contact with the buoy 52a.
  • the liquid in the intermediate layer M2 in the second syringe cylinder 21 can be selectively moved into the third syringe cylinder 31.
  • the intermediate layer M2 containing PRP is housed in the third syringe cylinder 31.
  • An injection needle (not shown) may be attached to the third port 33 to administer PRP to the affected area of the patient.
  • FIG. 21 is a diagram showing an example of a flow of processing for preparing PRP from blood using a preparation kit 110e having one first buoy 51 and one second buoy 52 shown in FIG.
  • the first buoy 51 is located in the first syringe cylinder 11
  • the second buoy 52 is located in the second syringe cylinder 21.
  • a syringe unit combining a second syringe cylinder 21 connected to the first gasket 14 and a third syringe 30 connected to the second gasket 24 is pulled in a direction of pulling out the first gasket 14 from the inside of the first syringe cylinder 11. ..
  • the first gasket 14 moves and blood is contained in the first syringe cylinder 11.
  • the syringe unit in which the second syringe cylinder 21 and the third syringe 30 are combined serves as a plunger for moving the first gasket 14.
  • the first cap 16 is attached to the first port 13.
  • the first buoy 51 When the first buoy 51 comes into contact with the first gasket 14, the first buoy 51 is provided with a flow path of liquid into the second syringe cylinder 21 provided in the first gasket 14 (for example, the first mounting hole 141). ) May be closed. In this case, the liquid in the light layer L1 in the first syringe cylinder 11 can be more selectively moved into the second syringe cylinder 21. That is, the possibility that the liquid in the heavy layer H1 in the first syringe cylinder 11 moves into the second syringe cylinder 21 can be reduced.
  • the second buoy 52 When the second buoy 52 comes into contact with the second gasket 24, the second buoy 52 is provided with a flow path of liquid into the third syringe cylinder 31 provided in the second gasket 24 (for example, the second mounting hole 241). ) May be closed.
  • the liquid of the light layer L2 in the second syringe cylinder 21 can be more selectively moved into the third syringe cylinder 31. That is, the possibility that the liquid in the heavy layer H2 in the second syringe cylinder 21 moves into the third syringe cylinder 31 can be reduced. As a result, only the heavy layer H2 containing PRP remains in the second syringe cylinder 21.
  • the third syringe 30 is removed from the second gasket 24 and instead a second plunger 22 is attached to the second gasket 24.
  • the liquid containing PRP in the second syringe cylinder 21 can be discharged from the inside of the second syringe cylinder 21 by using the second plunger 22.
  • An injection needle (not shown) may be attached to the second port 23 to administer PRP to the affected area of the patient.
  • FIG. 22 is a diagram showing another example of the flow of processing for preparing PRP from blood using the preparation kit 110e shown in FIG.
  • the first buoy 51 is located in the first syringe cylinder 11, and the buoy 52a and the buoy 52b are located in the second syringe cylinder 21.
  • State ⁇ 2e> ⁇ State ⁇ 5e>
  • Each of the states ⁇ 2e> to the state ⁇ 5e> has the same state as the above-mentioned state ⁇ 2d> to the state ⁇ 5d> except that the buoy 52a and the buoy 52b are located in the second syringe cylinder 21. Shows.
  • buoy 52a When a buoy 52a having a specific density smaller than that of the heavy layer H2 and larger than that of the intermediate layer M2 is used, the buoy 52a is located at the boundary between the heavy layer H2 and the intermediate layer M2. Further, when a buoy 52b having a specific density smaller than the specific gravity of the intermediate layer M2 and larger than the specific gravity of the light layer L2 is used, the buoy 52b is located at the boundary between the intermediate layer M2 and the light layer L2.
  • the buoy 52b When the buoy 52b comes into contact with the second gasket 24, the buoy 52b closes the liquid flow path (for example, the second mounting hole 241) into the third syringe cylinder 31 provided in the second gasket 24. May be good.
  • the liquid of the light layer L2 in the second syringe cylinder 21 can be more selectively moved into the third syringe cylinder 31. That is, it is possible to reduce the possibility that the liquid of the intermediate layer M2 and the liquid of the heavy layer H2 in the second syringe cylinder 21 move into the third syringe cylinder 31.
  • the heavy layer H2 containing leukocytes and the intermediate layer M2 containing PRP remain in the second syringe cylinder 21 from which the liquid of the light layer L2 is taken out.
  • the second plunger 22 is attached to the second gasket 24 and the second cap 26 is removed from the second port 23
  • only the liquid in the layer closer to the second port 23 (that is, the heavy layer H2) than the buoy 52a can be used. It can be discharged from the 2 port 23. This also makes it possible to reduce the amount of leukocytes contained in PRP.
  • the buoy 52a has a through hole.
  • the liquid in the intermediate layer M2 can also be discharged from the second port 23.
  • an injection needle (not shown) may be attached to the second port 23 to administer PRP to the affected area of the patient.
  • FIG. 23 is a diagram showing another example of the flow of processing for preparing PRP from blood using the preparation kit 110e shown in FIG.
  • the same reference numerals are added to the same states as those described in the above embodiment, and the description is not repeated.
  • the second buoy 52 When the second buoy 52 comes into contact with the second gasket 24, the second buoy 52 is provided with a flow path of liquid into the third syringe cylinder 31 provided in the second gasket 24 (for example, the second mounting hole 241). ) May be closed.
  • the liquid in the heavy layer H2 in the second syringe cylinder 21 can be more selectively moved into the third syringe cylinder 31. That is, the possibility that the liquid in the light layer L2 in the second syringe cylinder 21 moves into the third syringe cylinder 31 can be reduced.
  • the third syringe 30 is removed from the second gasket 24.
  • the heavy layer H2 which is a liquid containing PRP in the third syringe cylinder 31
  • An injection needle may be attached to the third port 33 to administer PRP to the affected area of the patient.
  • FIG. 24 is a diagram showing an example of a flow of processing for preparing PRP from blood using the preparation kit 110f shown in FIG.
  • State ⁇ 1g> ⁇ State ⁇ 6g>
  • the states ⁇ 1g> to ⁇ 6g> are the above-mentioned states ⁇ 1d> to ⁇ 5d> and the state ⁇ 6f>, respectively, except that the third buoy 53 is located in the third syringe cylinder 31. It shows the same state as.
  • the second buoy 52 When the second buoy 52 comes into contact with the second gasket 24, the second buoy 52 is provided with a flow path of liquid into the third syringe cylinder 31 provided in the second gasket 24 (for example, the second mounting hole 241). ) May be closed.
  • the liquid in the heavy layer H2 in the second syringe cylinder 21 can be more selectively moved into the third syringe cylinder 31. That is, the possibility that the liquid in the light layer L2 in the second syringe cylinder 21 moves into the third syringe cylinder 31 can be reduced.
  • the liquid containing white blood cells (heavy layer H2) in the third syringe cylinder 31 can be discharged from the third syringe cylinder 31 using the third plunger 32, and the amount of white blood cells can be adjusted.
  • An injection needle (not shown) may be attached to the third port 33 to administer PRP (light layer L3) to the affected area of the patient.

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024043028A1 (ja) * 2022-08-25 2024-02-29 京セラ株式会社 シリンジシステム及びシリンジシステムの使用方法

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Publication number Priority date Publication date Assignee Title
JPS5754861A (en) * 1980-09-19 1982-04-01 Terumo Corp Blood serum separating member
JPS60107763U (ja) * 1983-12-26 1985-07-22 オリンパス光学工業株式会社 血液試料分離用部材
US4936315A (en) * 1988-10-20 1990-06-26 Lineback Paul I Methods and apparatus for obtaining arterial blood samples
JPH0581713U (ja) * 1992-04-03 1993-11-05 新潟化工株式会社 血液分離部材
JPH0581712U (ja) * 1992-04-03 1993-11-05 新潟化工株式会社 血液分離部材
JP2002204906A (ja) * 2001-01-15 2002-07-23 Fujirebio Inc 分離装置
WO2008050688A1 (en) * 2006-10-27 2008-05-02 Nipro Corporation Platelet-rich plasma separator and platelet-rich plasma separation method

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS5754861A (en) * 1980-09-19 1982-04-01 Terumo Corp Blood serum separating member
JPS60107763U (ja) * 1983-12-26 1985-07-22 オリンパス光学工業株式会社 血液試料分離用部材
US4936315A (en) * 1988-10-20 1990-06-26 Lineback Paul I Methods and apparatus for obtaining arterial blood samples
JPH0581713U (ja) * 1992-04-03 1993-11-05 新潟化工株式会社 血液分離部材
JPH0581712U (ja) * 1992-04-03 1993-11-05 新潟化工株式会社 血液分離部材
JP2002204906A (ja) * 2001-01-15 2002-07-23 Fujirebio Inc 分離装置
WO2008050688A1 (en) * 2006-10-27 2008-05-02 Nipro Corporation Platelet-rich plasma separator and platelet-rich plasma separation method

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024043028A1 (ja) * 2022-08-25 2024-02-29 京セラ株式会社 シリンジシステム及びシリンジシステムの使用方法
JPWO2024043028A1 (https=) * 2022-08-25 2024-02-29

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