WO2013146505A1 - Dispositif de séparation de composants sanguins et procédé de séparation de composants sanguins - Google Patents

Dispositif de séparation de composants sanguins et procédé de séparation de composants sanguins Download PDF

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Publication number
WO2013146505A1
WO2013146505A1 PCT/JP2013/057987 JP2013057987W WO2013146505A1 WO 2013146505 A1 WO2013146505 A1 WO 2013146505A1 JP 2013057987 W JP2013057987 W JP 2013057987W WO 2013146505 A1 WO2013146505 A1 WO 2013146505A1
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Prior art keywords
blood
reservoir
storage
storage part
component separation
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PCT/JP2013/057987
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English (en)
Japanese (ja)
Inventor
岡本恭典
鈴木康二
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株式会社ジェイ・エム・エス
株式会社Jimro
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Application filed by 株式会社ジェイ・エム・エス, 株式会社Jimro filed Critical 株式会社ジェイ・エム・エス
Publication of WO2013146505A1 publication Critical patent/WO2013146505A1/fr

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    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3693—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits using separation based on different densities of components, e.g. centrifuging

Definitions

  • the present invention relates to an apparatus for separating blood components used for centrifuging blood into blood components, and a blood component separating method for centrifuging blood into blood components.
  • a conventional blood bag 60 used for separating blood components includes a substantially rectangular bag body 61 made of plastic, a port 62 connected to the bag body 61, and the bag body 61 communicating with the bag body 61.
  • the liquid supply tubes 63, 64, and 65 are connected to each other.
  • child bags (not shown) for storing separated blood components (plasma components and leukocyte components) are connected to the ends of the liquid feeding tubes 64 and 65, respectively.
  • the separation of blood components using the blood bag 60 was performed as follows. First, the collected blood is stored in the bag body 61 via the liquid feeding tube 63. At this time, the port 62 and the liquid feeding tubes 64 and 65 are closed. Thereafter, it is centrifuged. Thereby, the blood in the bag body 61 is separated into a red blood cell layer A, a plasma layer B, and a white blood cell layer C containing platelets as shown in FIG. Next, the liquid supply tube 64 is brought into a communication state, and the bag body 61 is pressurized. As a result, the plasma layer B is transferred to the child bag connected to the end of the liquid supply tube 64 via the liquid supply tube 64.
  • the liquid supply tube 65 is brought into a communication state, and the bag body 61 is pressurized. Thereby, the leukocyte layer C is transferred via the liquid supply tube 65 to another child bag connected to the end of the liquid supply tube 65. Thus, the separation of each blood component is completed.
  • the white blood cell component occupying in the blood is smaller than other components, and in the conventional blood bag 60 shown in FIG. 15, the white blood cell layer C is separated as a very thin layer between the red blood cell layer A and the plasma layer B. Is done. For this reason, after pressurizing the bag main body 61 and transferring the plasma layer B to the child bag via the liquid feeding tube 64, the white blood cell component remains in the red blood cell layer A without mixing the red blood cell component into the white blood cell component. Without it, it was not easy to transfer the leukocyte layer C to the child bag via the liquid feeding tube 65. That is, with the conventional blood bag 60, it has been difficult to successfully collect the white blood cell component.
  • the leukocyte layer C was moved in the bag main body 61 to be transferred to the child bag, the white blood cell components adhered to the inner surface of the bag main body 61, and it was difficult to collect all leukocyte components.
  • a blood bag 66 shown in FIG. 16 has been proposed as a blood component separating blood bag capable of solving these problems (see, for example, Patent Document 1).
  • the blood bag 66 shown in FIG. 16 includes a bag main body 67 for storing blood, and a liquid feeding tube 68 connected to the bag main body 67 so as to transfer the collected blood to the bag main body 67.
  • the bag body 67 is located at both end portions of the bag, and stores the first bag portion 69, the second bag portion 70, the first bag portion 69, and the second bag that store the red blood cell layer A and the plasma layer B after blood component separation, respectively.
  • the third bag portion 71 is located in the middle portion of the portion 70 and stores the leukocyte layer C after blood component separation.
  • the width of the third bag portion 71 is set shorter than the widths of the first and second bag portions 69 and 70.
  • the first, second, and third bag portions 69, 70, 71 are provided with ports 72, 73, 74 for taking out the contents after blood component separation, respectively.
  • the blood bag 66 seals the boundary portion between the first bag portion 69 and the third bag portion 71 and the boundary portion between the third bag portion 71 and the second bag portion 70, respectively.
  • the second and third bag portions 69, 70, 71 can be separated. This makes it possible to separate blood into pure blood components without mixing other blood components, and in particular, it is possible to improve the recovery rate of white blood cell components.
  • the hematocrit value is a numerical value indicating the proportion of the blood cell volume in the blood.
  • the normal value is about 40 to 50% for adult men and about 35 to 45% for adult women.
  • the hematocrit value may be lower or higher than the normal value for some reason.
  • blood hematocrit values vary to some extent, and in order to further improve the recovery rate of leukocyte components, it is necessary to develop a new blood component separation device and blood component separation method that take hematocrit values into account. It is essential.
  • An object of the present invention is to provide a blood component separation device and a blood component separation method that can improve the recovery rate of leukocyte components.
  • a blood component separation device includes a blood reservoir for storing blood, and is used for centrifuging blood stored in the blood reservoir into blood components.
  • the blood reservoir is provided between the first reservoir, the second reservoir, the first reservoir, and the second reservoir, and communicates with each of the first and second reservoirs. 3 reservoirs.
  • the apparatus further includes a volume adjustment mechanism capable of adjusting the volume of the blood storage unit.
  • the blood component separation method relates to a method of centrifuging blood stored in a blood reservoir into each blood component.
  • the blood reservoir is provided between the first reservoir, the second reservoir, the first reservoir, and the second reservoir, and communicates with each of the first and second reservoirs. 3 reservoirs.
  • the volume of the blood reservoir is adjusted based on the hematocrit value and amount of blood stored in the blood reservoir so that the buffy coat after centrifugation is collected in the third reservoir. An adjustment process is provided.
  • the “buffy coat” is a layer containing white blood cells and platelets and formed between the red blood cell layer and the plasma layer after blood is centrifuged.
  • the volume of the blood reservoir is adjusted based on the hematocrit value and the amount of blood stored in the blood reservoir, and the buffy coat after centrifugation is collected in the third reservoir. Is possible. This makes it possible to easily collect leukocyte components of blood more easily and without being an expert, and to further improve the recovery rate of leukocyte components. .
  • FIG. 1 is a schematic perspective view showing a configuration of a blood component separation device according to an embodiment of the present invention.
  • FIG. 2 is a schematic longitudinal sectional view showing the configuration of the blood component separation device according to one embodiment of the present invention.
  • FIG. 3A is a schematic cross-sectional view showing another diaphragm mechanism used in the blood component separation device of the present invention.
  • 3B is a schematic cross-sectional view showing the operation of the diaphragm mechanism shown in FIG. 3A.
  • FIG. 4 is a schematic cross-sectional view showing another configuration of the connection portion in the blood component separation device according to the present invention.
  • FIG. 5 is a schematic cross-sectional view showing another arrangement of outlets provided at both ends of the third reservoir in the blood component separation device according to the present invention.
  • FIG. 6A is a schematic perspective view showing another configuration of the second reservoir in the blood component separation device of the present invention.
  • 6B is a schematic cross-sectional view of the second reservoir shown in FIG. 6A.
  • FIG. 7 is a schematic exploded perspective view showing the configuration of the posture holder used for holding the blood component separation device in one embodiment of the present invention in a stable state when performing centrifugation.
  • FIG. 8 is a schematic perspective view showing a state in which the blood component separation device according to one embodiment of the present invention is held by a posture holder.
  • FIG. 9 is a flowchart for explaining a blood component separation method according to an embodiment of the present invention.
  • FIG. 10 is a schematic perspective view showing a state in which the separated leukocyte component is being collected.
  • FIG. 10 is a schematic perspective view showing a state in which the separated leukocyte component is being collected.
  • FIG. 11 is a schematic longitudinal sectional view showing the configuration of a concentration device for washing and concentrating the collected leukocyte component.
  • FIG. 12 is a flowchart for explaining a method for collecting, washing, and concentrating separated leukocyte components.
  • FIG. 13 is a schematic longitudinal sectional view showing another example of the volume adjustment mechanism constituting the blood component separation device according to one embodiment of the present invention.
  • FIG. 14 is a schematic longitudinal sectional view showing still another example of the volume adjustment mechanism constituting the blood component separation device according to one embodiment of the present invention.
  • FIG. 15 is a schematic longitudinal sectional view showing a conventional blood bag used for separating blood components.
  • FIG. 16 is a schematic longitudinal sectional view showing a conventional improved blood bag used for separating blood components.
  • the volume adjusting mechanism is provided so as to adjust the volume of the first reservoir or the second reservoir. According to this preferred example, since the volume of the third storage portion does not change, a sufficient storage space for the white blood cell component can be ensured.
  • the volume adjustment mechanism may be a diaphragm mechanism having a diaphragm that can expand and contract, a piston mechanism having a piston member that can move forward and backward, or a screw member that can move forward and backward. It is preferable to include the provided screw mechanism. According to this preferred example, the volume of the blood reservoir can be easily adjusted with a simple configuration.
  • the first to third reservoirs are each formed in a substantially cylindrical shape, and the diameter of the third reservoir is smaller than the diameters of the first and second reservoirs. It is preferable that it is set. According to this preferred example, since the leukocyte component layer can be present in a relatively thick layer, the leukocyte component can be efficiently recovered.
  • a connecting portion is provided between each of the first and second reservoirs and the third reservoir.
  • the connecting portion is made of a flexible tube. According to this preferred example, after centrifuging the blood stored in the blood storage part into each blood component, by sealing or clamping each connection part, between the first storage part and the third storage part, and The second reservoir and the third reservoir can be blocked.
  • connection part is inserted into each port of the first storage part, the second storage part, and the third storage part, so that the first storage part, the second storage part, And it is preferable that it is connected with the said 3rd storage part.
  • outlets for collecting blood components stored in the third reservoir after centrifugation are provided at both ends of the third reservoir.
  • physiological saline is provided at one outlet.
  • a recovery container such as a syringe is connected to the other outlet, and the leukocyte component can be recovered while washing with physiological saline.
  • the third reservoir includes a port for communicating with the first reservoir and the second reservoir, respectively.
  • the outlet is disposed in contact with the port. According to this preferable example, it is possible to suppress the leukocyte component from staying in the vicinity of the port, so that the recovery rate of the leukocyte component can be further improved.
  • an inlet for injecting blood into the blood reservoir is provided in one of the first reservoir and the second reservoir. More preferably, the inlet is provided in the first reservoir.
  • the blood component separation device of the present invention further includes a ventilation filter that communicates the inside and outside of the blood reservoir.
  • the ventilation filter includes the third of the other of the first storage unit and the second storage unit (that is, the one of the first storage unit and the second storage unit in which the inlet is not provided). It is preferable to be arranged at a position eccentric with respect to the port communicating with the reservoir. According to this preferred example, when blood is injected into the blood reservoir, it is possible to reduce the possibility of occurrence of a situation in which blood adheres to the ventilation filter and the ventilation performance of the ventilation filter decreases.
  • the method further includes a step of blocking between the second storage unit and the third storage unit. According to this preferred example, the recovery rate of the leukocyte component can be further improved.
  • each drawing referred to in the following description shows only main members necessary for explaining the present invention in a simplified manner among members constituting the embodiment of the present invention. Therefore, the present invention can include any member not shown in the following drawings. Moreover, the dimension of the member in each following figure does not represent the dimension of an actual member, the dimension ratio of each member, etc. faithfully.
  • FIG. 1 is a schematic perspective view showing the configuration of a blood component separation device 1 (hereinafter simply referred to as “device 1”) in one embodiment of the present invention
  • FIG. 2 is a schematic longitudinal section showing the configuration of the device 1 FIG.
  • the device 1 in the present embodiment includes a blood reservoir 2 for storing blood, and centrifuges blood stored in the blood reservoir 2 into each blood component. Used for.
  • the blood reservoir 2 is provided between the first reservoir 4, the second reservoir 5, and the first reservoir 4 and the second reservoir 5, and each of the first and second reservoirs 4, 5 And a third storage section 6 communicating with the first storage section 6.
  • the first reservoir 4 is a space for storing red blood cell components after centrifugation
  • the second reservoir 5 is a space for storing plasma components after centrifugation
  • the third reservoir 6 is centrifuged. This is a space for later storing leukocyte components.
  • the apparatus 1 further includes a volume adjustment mechanism 3 that can adjust the volume of the blood reservoir 2.
  • the volume of the blood reservoir 2 is adjusted based on the hematocrit value and the amount of blood stored in the blood reservoir 2, and the buffy coat after the centrifugation is the third. It is possible to gather in the storage unit 6. This makes it possible to easily collect leukocyte components of blood more easily and without being an expert, and to further improve the recovery rate of leukocyte components. .
  • the position where the buffy coat after centrifugation is collected is determined by measuring the amount of blood stored in the blood reservoir 2 and the hematocrit value. May occur.
  • the volume adjustment mechanism 3 capable of adjusting the volume of the blood reservoir 2 is provided, the position where the buffy coat after centrifugation is collected can be easily finely adjusted. Become.
  • the volume adjusting mechanism 3 is provided so as to adjust the volume of the first storage unit 4 or the second storage unit 5. According to this desirable configuration, since the volume of the third reservoir 6 does not change, a sufficient storage space for the white blood cell component can be ensured.
  • a diaphragm mechanism is provided at the lower end opening of the first reservoir 4 as the volume adjusting mechanism 3.
  • the diaphragm mechanism is provided in a liquid-tight state on the base 7 attached to the lower end opening of the first reservoir 4 in a liquid-tight state, and on the upper surface side (the first reservoir 4 side) of the base 7, and is expanded and contracted.
  • a possible diaphragm 8 is provided.
  • physiological saline is injected into a space (adjustment chamber) 3 a between the upper surface of the base 7 and the diaphragm 8 to expand the diaphragm 8, and the physiological saline in the adjustment chamber 3 a is discharged.
  • reference numeral 9 a indicates a water supply / drainage port provided on the side surface of the base 7. If a diaphragm mechanism is used as the volume adjustment mechanism 3 in this way, the volume of the blood reservoir 2 can be easily adjusted with a simple configuration.
  • the diaphragm 8 is in close contact with the concave curved upper surface of the base 7 in an initial state where physiological saline is not injected, and the volume of the adjustment chamber 3a is minimized (preferably zero).
  • the volume of the first storage unit 4 (the volume of the space in which blood can be stored) may be maximized.
  • the volume of the 1st storage part 4 can be changed arbitrarily by adjusting the quantity of the physiological saline inject
  • the diaphragm mechanism in which the volume of the adjustment chamber 3a is the minimum (preferably zero) in the initial state as shown in FIG. 3A is obtained when the volume of the adjustment chamber 3a is expanded by injecting physiological saline.
  • air is not easily mixed in. Since air has compressibility, if air exists in the adjustment chamber 3a, the volume of the adjustment chamber 3a changes due to the centrifugal force at the time of centrifugation. As a result, the position of the buffy coat varies, and the recovery rate of the white blood cell component decreases.
  • the first, second, and third reservoirs 4, 5, and 6 are each formed in a substantially cylindrical shape, and the diameter (particularly the inner diameter) of the third reservoir 6 is the first and second. It is desirable that the diameter is set smaller than the diameter (particularly the inner diameter) of the reservoirs 4 and 5. More specifically, the ratio of the inner diameter of the third reservoir 6 to the inner diameters of the first and second reservoirs 4 and 5 (the inner diameter of the third reservoir / the inner diameters of the first and second reservoirs) is 0. It is desirable to set in the range of 2 to 0.5, and it is desirable to set in the range of 0.35 to 0.4. According to this desirable configuration, since the leukocyte component layer can be present in a relatively thick layer, the leukocyte component can be efficiently recovered.
  • the first and second reservoirs 4 and 5 have an inner diameter of about 40 mm to 95 mm and an outer diameter of about 42 mm to 97 mm
  • the third reservoir 6 has an inner diameter of about 15 mm to 44 mm and an outer diameter. Is about 17 mm to 46 mm, and the length of the third reservoir 6 is about 30 mm to 45 mm.
  • the first reservoir 4 has an inner diameter of 51 mm and an outer diameter of 55 mm
  • the second reservoir 5 has an inner diameter of 56 mm, an outer diameter of 60 mm
  • a third reservoir. 6 has an inner diameter of 20 mm, an outer diameter of 24 mm, and a length of 39 mm.
  • the first reservoir 4 has an inner diameter of 66 mm and an outer diameter of 97 mm.
  • the second reservoir 5 can be set to an inner diameter of 92 mm and an outer diameter of 97 mm
  • the third reservoir 6 can be set to an inner diameter of 27 mm, an outer diameter of 31 mm, and a length of 43 mm.
  • the first, second and third reservoirs 4, 5, 6 have transparency from the viewpoint of allowing the blood stored in the first, second and third reservoirs 4, 5, 6 to be visible. It is desirable that the material is composed of a material, and it is desirable that the material is composed of a material having relatively high rigidity.
  • the material constituting the first, second and third reservoirs 4, 5, and 6 include polycarbonate, polyethylene, PP (polypropylene), polyester, polymethylpentene, methacryl, ABS resin (acrylonitrile / butadiene / styrene). Polymer), PET resin (polyethylene terephthalate), PVC (polyvinyl chloride), and the like.
  • connection portions 10 and 11 are provided between the first and second storage portions 4 and 5 and the third storage portion 6, respectively. And it is desirable for the connection parts 10 and 11 to consist of a tube which has flexibility from a viewpoint which can be sealed or clamped. Moreover, it is desirable that the connection portions 10 and 11 are made of a transparent material from the viewpoint of making it possible to visually recognize the blood stored in the connection portions 10 and 11. Examples of the material constituting the connecting portions 10 and 11 include rubber, PVC, PP, PBD (polybutadiene), polyurethane, silicone, and polyethyl acetate. Among these, PVC is particularly desirable.
  • the inner diameters of the connection portions 10 and 11 are about 2.0 mm to 4.0 mm.
  • the first storage unit 4 and the third storage unit 6 are connected by a connection unit 10 made of a flexible tube, and the second storage unit 5 and the third storage unit 6 are Similarly, it is connected by a connecting portion 11 made of a flexible tube. And according to this structure, after centrifuging the blood stored in the blood storage part 2 into each blood component, the first storage part 4 and the third storage part are sealed or clamped by the connection parts 10 and 11. 6 and between the second reservoir 5 and the third reservoir 6 can be blocked.
  • FIG. 4 is a cross-sectional view showing a preferred configuration of the connecting portion 10.
  • one end of the connection portion 10 is inserted into the cylindrical port 4 a of the first storage portion 4, and the other end of the connection portion 10 is the cylindrical shape of the third storage portion 6. It is preferably inserted into the port 6a. That is, it is preferable to connect the connection part 10 to the first storage part 4 and the third storage part 6 so that the ports 4 a and 6 a are arranged outside the connection part 10.
  • the pressure in the blood storage part 2 rises, and this deforms the flexible connecting part 10 to expand its diameter. Contrary to FIG.
  • a step is not substantially formed between the inner peripheral surface 10s of the connecting portion 10 and the inner peripheral surfaces 4s and 6s of the portion where the connecting portion 10 of the ports 4a and 6a is not inserted (that is, the inner diameter It is preferable that the inner diameter of the region in which the connection portion 10 of the ports 4a and 6a is inserted is expanded according to the thickness of the connection portion 10 so that no change occurs. This is advantageous in preventing hemolysis and improving the recovery rate of nucleated cells (or leukocyte components).
  • connection between the connection portion 11 and the port 5a of the second storage portion 5 and the port 6b of the third storage portion 6 is also configured in the same manner as described in FIG. In this case, the same effects as described above can be obtained.
  • outlets 12 and 13 for collecting leukocyte components stored in the third reservoir 6 after centrifugation are provided at both ends of the third reservoir 6, respectively. It is desirable that then, according to this desirable configuration, after blocking between the first storage unit 4 and the third storage unit 6 and between the second storage unit 5 and the third storage unit 6, for example, A syringe filled with physiological saline is connected to the outlet 12, a collection container such as a syringe is connected to the other outlet 13, white blood cells are injected into the third reservoir 6, and washed with the physiological saline while washing with white blood cells. Ingredients can be recovered.
  • the white blood cell component in the vicinity of the port 6a may not be collected.
  • the port 6b of the third reservoir 6 to which the connecting portion 11 is connected and the outlet 12 are separated, there is a possibility that the white blood cell component in the vicinity of the port 6b cannot be collected. Therefore, as shown in FIG. 5, it is preferable that the opening on the third reservoir 6 side of the cylindrical outlet 13 is brought into contact with the opening on the third reservoir 6 side of the cylindrical port 6a.
  • the outlet 13 may be branched from the port 6a.
  • the opening on the third reservoir 6 side of the cylindrical outlet 12 is brought into contact with the opening on the third reservoir 6 side of the cylindrical port 6b.
  • the outlet 12 may be branched from the port 6b. In this way, by bringing the outlets 13 and 12 into contact with the ports 6a and 6b, it is possible to prevent the leukocyte component from staying in the vicinity of the ports 6a and 6b, and to improve the leukocyte component recovery rate.
  • the outlets 12, 13 are arranged so that the outlets 12, 13 intersect obliquely (that is, neither perpendicular nor parallel) with respect to the central axis 6 c of the third reservoir 6. 13 may be inclined. Thereby, since it can further suppress that a white blood cell component retains in the 3rd storage part 6, the recovery rate of a white blood cell component further improves.
  • an inlet 14 for injecting blood into the blood reservoir 2 is provided on the upper surface of the first reservoir 4.
  • the outlets 12 and 13 are sealed in a liquid-tight state.
  • the injection port 14 is sealed in a liquid-tight state after the injection of blood into the blood reservoir 2 is completed.
  • a ventilation filter 15 is attached to the upper surface of the second storage unit 5.
  • the ventilation filter 15 is a filter having a property of allowing gas to pass but not allowing liquid to pass, and also preventing bacteria and the like from passing through.
  • the ventilation filter 15 allows the inside of the blood reservoir 2 and the outside air to communicate with each other in an air-permeable manner. is doing.
  • the ventilation filter 15 allows the inside of the blood reservoir 2 and the outside air to communicate with each other in an air-permeable manner. is doing.
  • an excessive increase in the pressure in the blood reservoir 2 is reduced, and a desired amount of blood is injected into the blood reservoir 2 without reducing the rate of blood injection into the blood reservoir 2. It becomes possible.
  • the 2nd storage part 5 is formed with a soft material and the inside of the blood storage part 2 is not satisfy
  • FIG. 6A is a perspective view of another example of the second reservoir 5, and FIG. 6B is a cross-sectional view thereof.
  • the columnar knob 5k protrudes upwards in the center of the upper surface.
  • the knob 5k can be used as a handle when the device 1 is held and moved.
  • a ventilation filter 15 is provided on the side surface of the knob 5k.
  • the ventilation filter 15 is disposed coaxially with the port 5 a of the second storage unit 5 connected to the connection unit 11. In this case, when blood is injected into the blood reservoir 2 from the inlet 14, the blood may spout upward from the port 5 a into the second reservoir 5 and wet the ventilation filter 15.
  • the ventilation filter 15 is arranged at a position eccentric with respect to the connection portion 11 and the port 5a. Thereby, when injecting blood into the blood reservoir 2, the possibility of blood adhering to the ventilation filter 15 is reduced, and the air permeability desired by the ventilation filter 15 can be maintained.
  • the ventilation filter 15 is provided on the side surface of the knob 5k. However, if the ventilation filter 15 is eccentric with respect to the connection portion 11 and the port 5a, the ventilation passage is provided at a position other than the knob 5k of the second storage portion 5.
  • a filter 15 may be provided.
  • the knob 5k has a substantially cylindrical shape, but may have any other shape. For example, it may have an inverted “U” shape so that a finger can be inserted. Further, the inside of the knob 5k may not be hollow.
  • the lower inner peripheral surface 5s of the second reservoir 5 preferably has a funnel shape (that is, a conical surface shape or a tapered surface shape).
  • the inner peripheral surface 5s is inclined so as to descend as it approaches the port 5a. This means that blood cell components having a relatively high specific gravity, such as red blood cells in the second reservoir 5a, are ported during centrifugation. It is easy to move to the first reservoir 4 through 5a.
  • the inclination angle ⁇ of the inner peripheral surface 5s with respect to the horizontal direction is not particularly limited, but is preferably 10 to 45 degrees, more preferably 15 to 30 degrees, and can be set to 20 degrees as an example.
  • the inner peripheral surface 5s does not need to be an accurate conical surface, and may be an inclined surface in which the inclination angle ⁇ of the inner peripheral surface 5s varies depending on the distance along the horizontal direction from the port 5a.
  • the 1st storage part 4 and the 3rd storage part 6 are connected by the connection part 10 which consists of a tube which has flexibility, and the 2nd storage part 5 and the 3rd storage part 6 are also possible. It is connected by a connecting portion 11 made of a flexible tube.
  • the device 1 is in an unstable state because it includes a flexible tube as a component, and when performing centrifugation to separate the blood in the blood reservoir 2 into each blood component, It is necessary to maintain the posture of the apparatus 1 so as to be in a stable state.
  • the configuration of the posture holder used to hold the posture of the apparatus 1 in a stable state when performing centrifugation will be described.
  • FIG. 7 is a schematic exploded perspective view showing the configuration of the posture holder used for holding the apparatus 1 in a stable state in one embodiment of the present invention when performing centrifugation
  • FIG. It is a schematic perspective view which shows the state which hold
  • the posture holder 16 is attached to the device 1 so as to sandwich the device 1 from both the front and rear sides, and has a substantially semi-cylindrical first posture holding having a flat front surface.
  • a member 17 and a second semi-cylindrical second posture holding member 18 are provided.
  • position holding members 17 and 18 are comprised with the material which has transparency from a viewpoint which makes visible the blood (red blood cell component, plasma component, white blood cell component) stored in the blood storage part 2 to accommodate.
  • it is made of a material having relatively high rigidity.
  • the material constituting the first and second posture holding members 17 and 18 include polycarbonate, polyethylene, PP, polyester, polymethylpentene, methacryl, ABS resin, PET resin, PVC, and the like.
  • a first storage portion storage portion 25 that stores the first storage portion 4 when the first and second posture holding members 17 and 18 are attached to the apparatus 1. Is formed.
  • a second storage portion storage portion 26 that stores the second storage portion 5 when the first and second posture holding members 17 and 18 are attached to the apparatus 1. Is formed.
  • a third storage portion storage that stores the third storage portion 6 when the first and second posture holding members 17 and 18 are attached to the apparatus 1 is provided at the substantially central portion of the first and second posture holding members 17 and 18.
  • a portion 27 is formed.
  • the apparatus 1 further includes take-out tubes 23 and 24 connected to the take-out ports 12 and 13 at both ends of the third storage unit 6, respectively.
  • the first and second posture holding members 17 and 18 have take-out tube storage portions 28a and 28b for storing the take-out tubes 23 and 24 when the first and second posture holding members 17 and 18 are attached to the apparatus 1. Is connected to the external space.
  • the take-out tube storage portions 28a and 28b are formed upward from both ends of the third storage portion storage portion 27, respectively.
  • the first and second posture holding members 17, 18 are formed with connection portion storage portions 29 a, 29 b located between the first and second storage portion storage portions 25, 26 and the third storage portion storage portion 27. Has been.
  • the connection portion storage portions 29a and 29b are configured to store the connection portions 10 and 11 provided between the first and second storage portions 4 and 5 and the third storage portion 6, respectively.
  • the first posture holding member 17 is formed with an insertion hole 30a that is orthogonal to the connection portion storage portion 29a and connects the substantially central portion of the connection portion storage portion 29a and the external space.
  • a stop member 31a can be inserted into the insertion hole 30a.
  • the second posture holding member 18 is formed with an insertion hole 30b that is orthogonal to the connection portion storage portion 29b and connects the substantially central portion of the connection portion storage portion 29b and the external space.
  • a stop member 31b can be inserted into the insertion hole 30b. Then, when the stopper members 31a and 31b are inserted into the insertion holes 30a and 30b, the connection portions 10 and 11 can be clamped.
  • the stopper members 31a and 31b are prevented from easily falling out of the insertion holes 30a and 30b when the claw portions thereof are locked to the locking portions in the insertion holes 30a and 30b.
  • the posture holder 16 is formed with four fastening pin insertion holes 32, 33, 34, 35 across both the first posture holding member 17 and the second posture holding member 18. Then, by inserting the four fastening pins 19, 20, 21, and 22 into the fastening pin insertion holes 32, 33, 34, and 35, the first posture holding member 17 and the second posture holding member 18 are joined. It is made to be able to fasten in the state made to do.
  • FIG. 9 is a flowchart for explaining a blood component separation method according to an embodiment of the present invention.
  • the amount of erythrocyte component and the amount of plasma are calculated from the hematocrit value of blood and the liquid volume.
  • the volume of the blood reservoir 2 is adjusted by the diaphragm mechanism that is the volume adjustment mechanism 3 so that the buffy coat after centrifugation is collected in the third reservoir 6 of the apparatus 1 (S102 in FIG. 9). More specifically, physiological saline is injected into the adjustment chamber 3 a between the upper surface of the base 7 and the diaphragm 8 from the water supply / drain port 9 a provided on the side surface of the base 7 of the diaphragm mechanism which is the volume adjustment mechanism 3. Then, the volume of the blood reservoir 2 is adjusted by expanding the diaphragm 8.
  • the blood (bone marrow fluid) obtained in the preparation step S101 is injected from the inlet 14 provided on the upper surface of the first reservoir 4 into the blood reservoir 2 (capacity 50 ml to 400 ml) of the apparatus 1. (S103 in FIG. 9). Depending on the amount of liquid, 1 to 4 sets of apparatus 1 are used.
  • the first posture holding member 17 and the second posture holding member 18 are attached to the device 1 into which blood (bone marrow fluid) has been injected so that the device 1 is sandwiched from both the front and rear sides.
  • blood bone marrow fluid
  • the first posture holding member 17 and the second posture holding member 18 are fastened in a joined state.
  • the posture holder 16 is mounted in a state where the take-out tubes 23 and 24 are connected to the take-out ports 12 and 13 at both ends of the third storage unit 6, respectively (S ⁇ b> 104 in FIG. 9).
  • the device 1 to which the posture holder 16 is mounted is applied to a centrifuge and centrifuged (S105 in FIG. 9).
  • the centrifugal force acts in the direction of arrow F in FIG.
  • FIG. 10 is a schematic perspective view showing a state where the separated leukocyte component is collected
  • FIG. 11 is a schematic longitudinal sectional view showing a concentration device for washing and concentrating the collected leukocyte component
  • FIG. 12 is a separated leukocyte. It is a flowchart for demonstrating the collection
  • the concentration device 37 for washing and concentrating the collected leukocyte components includes a leukocyte component reservoir 38 for storing the collected leukocyte components and a supernatant in the leukocyte component reservoir 38 after centrifugation.
  • a supernatant accommodating part 39 for accommodating, and a connecting tube 40 for aseptically connecting the leukocyte component storing part 38 and the supernatant accommodating part 39 are provided.
  • reference numeral 41 indicates a centrifuge holder that holds the leukocyte component reservoir 38 and the supernatant container 39 when the leukocyte component in the leukocyte component reservoir 38 is centrifuged.
  • the white blood cell component storage unit 38 includes a white blood cell component storage container 42, a first storage container 43 that stores the white blood cell component storage container 42, and a first cap 44 that is joined to the white blood cell component storage container 42 and the first storage container 43. I have.
  • the white blood cell component storage container 42 has a vertically long cylindrical shape, and the side surface is made of a flexible material.
  • the side surface of the white blood cell component storage container 42 is made of a transparent material from the viewpoint of making the white blood cell component stored in the white blood cell component storage container 42 visible.
  • the white blood cell component storage container 42 is made of PVC.
  • the upper end, which is one end of the leukocyte component storage container 42, is an opening and is fitted into the first cap 44 and sealed.
  • the first storage container 43 has a vertically long cylindrical shape like the leukocyte component storage container 42, and both the diameter and height thereof are larger than that of the leukocyte component storage container 42.
  • a pressure adjustment space 45 that is a space independent of the internal space of the leukocyte component storage container 42 is formed between the leukocyte component storage container 42 and the first storage container 43.
  • the first container 43 is made of a transparent material from the viewpoint of making it possible to visually recognize the white blood cell component stored in the white blood cell component storage container 42.
  • the first storage container 43 is made of a material having relatively high rigidity.
  • the first container 43 is made of polycarbonate.
  • the transfer tube 46 is connected to the first cap 44, and the collected leukocyte component is aseptically stored in the leukocyte component storage container 42 via the transfer tube 46. Further, one end of a fluid injection tube 47 is connected to the first cap 44, and an injection means (not shown) capable of injecting fluid into the pressure adjustment space 45 is connected to the other end of the fluid injection tube 47.
  • an injection means a pump, a syringe, or the like can be used.
  • a gas such as air
  • a liquid such as water, a gel-like substance, or the like can be used.
  • the supernatant container 39 includes a supernatant container 48, a second container 49 that accommodates the supernatant container 48, and a second cap 50 that is joined to the supernatant container 48 and the second container 49. I have.
  • the supernatant container 48 has a vertically long cylindrical shape, and the side surface is made of a flexible material. Specifically, the supernatant container 48 is made of PVC. The upper end which is one end of the supernatant container 48 is an opening, and is fitted into the second cap 50 and sealed.
  • the second storage container 49 has a vertically long cylindrical shape like the supernatant storage container 48, and both the diameter and height thereof are larger than the supernatant storage container 48.
  • the upper end that is one end of the second container 49 is also an opening, and is fitted into the second cap 50 so that it can be sealed.
  • the second storage container 49 is made of a material having relatively high rigidity. Specifically, the second container 49 is made of polycarbonate.
  • the second cap 50 is connected to a vent tube 51 for allowing air to enter and exit from the supernatant container 48, and a tip of the vent tube 51 is provided with a vent filter 52.
  • a syringe 53 filled with physiological saline is connected to an extraction tube 23 connected to an outlet 12 at the upper end of the third reservoir 6 of the device 1.
  • An empty syringe 54 is connected to the extraction tube 24 connected to the outlet 13 at the lower end of the third reservoir 6.
  • Saline is injected from the syringe 53 into the third reservoir 6, and the white blood cell component in the third reservoir 6 is pushed out while being washed away with physiological saline, and collected in the syringe 54 (S ⁇ b> 201 in FIG. 12).
  • the collected leukocyte component is transferred into the leukocyte component storage container 42 of the leukocyte component storage unit 38 via the transfer tube 46 of the concentration device 37. Then, the leukocyte component in the leukocyte component storage container 42 is centrifuged (S202 in FIG. 12).
  • the pressure adjustment space 45 is pressurized.
  • the flexible white blood cell component storage container 42 is used to pressurize the pressure adjustment space 45. It is deformed so that it is crushed under the influence.
  • the separated supernatant 55 is led out through the connecting tube 40 and introduced into the supernatant container 39 (supernatant container 48) (S203 in FIG. 12).
  • heparin is removed by adding physiological saline again to the leukocyte component 56 remaining in the leukocyte component storage container 42 and washing it (S204 in FIG. 12).
  • the leukocyte component 56 in the leukocyte component storage container 42 is centrifuged again (S205 in FIG. 12).
  • the separated supernatant 55 is led out through the connecting tube 40 and introduced into the supernatant container 39 (supernatant container 48) (FIG. 12 S206).
  • physiological saline is added to the leukocyte component 56 remaining in the leukocyte component storage container 42 until the required amount of liquid is obtained to obtain a transplantation solution (about 20 ml) (S207 in FIG. 12).
  • transplantation solution is taken out from the leukocyte component storage container 42 with a syringe and transplanted to the bone marrow.
  • the leukocyte component collected in the syringe 54 of FIG. 10 can be directly administered to the patient without being washed and concentrated using the concentration device 37 shown in FIG.
  • the volume adjustment mechanism used in the blood component separation device of the present invention may be, for example, a piston mechanism including a piston member 57 that can move forward and backward as shown in FIG.
  • a screw mechanism including a screw member 58 that can move forward and backward may be used.
  • you may comprise a volume adjustment mechanism combining 2 or more of a diaphragm mechanism, a piston mechanism, and a screw mechanism.
  • the piston member 57 shown in FIG. 13 or the screw member 58 shown in FIG. 14 can be arranged below the diaphragm 8 shown in FIG. 2 or 3A.
  • the diaphragm 8 is driven by the piston member 57 or the screw member 58. Therefore, injection of physiological saline is not necessary, and the water channel 9 and the water supply / drain port 9a can be omitted.
  • the volume adjustment mechanism is configured using at least one of the diaphragm mechanism, the piston mechanism, and the screw mechanism, the volume of the blood reservoir 2 can be easily adjusted with a simple configuration. Become.
  • the volume adjustment step may be performed after the blood injection step or may be performed simultaneously with the blood injection step.
  • the present invention it is possible to easily collect leukocyte components of blood more efficiently and without being an expert, and to further improve the recovery rate of leukocyte components. Become. Therefore, the present invention is useful for blood component separation, bone marrow transplantation mainly using leukocyte components, and regenerative medicine when performing component transfusion for transfusion of only necessary components in blood.

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un dispositif (1) de séparation de composants sanguins qui comprend une partie de stockage de sang (2) conçue pour stocker du sang et un mécanisme de commande de capacité (3), la capacité de la partie de stockage de sang (2) pouvant être commandée. La partie de stockage de sang (2) comprend une première section de stockage (4), une deuxième section de stockage (5) et une troisième section de stockage (6), ladite troisième section de stockage (6) étant formée entre la première section de stockage (4) et la deuxième section de stockage (5) et communiquant avec chacune de la première section de stockage (4) et de la deuxième section de stockage (5). Le volume d'érythrocytes et le volume de plasma sanguin sont calculés sur la base de la valeur d'hématocrite et du volume liquide du sang stocké dans la partie de stockage de sang (2), et la capacité de la partie de stockage de sang (2) est donc commandée de telle sorte qu'une couche leuco-plaquettaire formée après centrifugation peut être accumulée dans la troisième section de stockage (6).
PCT/JP2013/057987 2012-03-30 2013-03-21 Dispositif de séparation de composants sanguins et procédé de séparation de composants sanguins WO2013146505A1 (fr)

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JP2012-078818 2012-03-30
JP2012078818 2012-03-30
JP2012-208202 2012-09-21
JP2012208202A JP2013226370A (ja) 2012-03-30 2012-09-21 血液成分分離用装置及び血液成分分離方法

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015045688A1 (fr) * 2013-09-25 2015-04-02 株式会社ジェイ・エム・エス Dispositif de séparation de constituants sanguins

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09206356A (ja) * 1996-02-05 1997-08-12 Nissho Corp 血液バッグ及び血液成分分離方法
JP2002291874A (ja) * 2001-03-29 2002-10-08 Jms Co Ltd 血液成分分離用血液バッグ及び血液分離方法
WO2010065018A1 (fr) * 2008-12-04 2010-06-10 Thermogenesis Corp. Appareil et procédé pour séparer et isoler des composants d’un fluide biologique

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH01199159A (ja) * 1988-02-04 1989-08-10 Kosumitsuku:Kk 遠心チューブ
WO2008143570A1 (fr) * 2007-05-23 2008-11-27 Ge Healthcare Bio-Sciences Ab Dispositif de séparation

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09206356A (ja) * 1996-02-05 1997-08-12 Nissho Corp 血液バッグ及び血液成分分離方法
JP2002291874A (ja) * 2001-03-29 2002-10-08 Jms Co Ltd 血液成分分離用血液バッグ及び血液分離方法
WO2010065018A1 (fr) * 2008-12-04 2010-06-10 Thermogenesis Corp. Appareil et procédé pour séparer et isoler des composants d’un fluide biologique

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015045688A1 (fr) * 2013-09-25 2015-04-02 株式会社ジェイ・エム・エス Dispositif de séparation de constituants sanguins
US10238787B2 (en) 2013-09-25 2019-03-26 Transell Co., Ltd. Blood component separation device

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