WO2022186122A1 - Blood bag system and blood treatment method - Google Patents

Blood bag system and blood treatment method Download PDF

Info

Publication number
WO2022186122A1
WO2022186122A1 PCT/JP2022/008229 JP2022008229W WO2022186122A1 WO 2022186122 A1 WO2022186122 A1 WO 2022186122A1 JP 2022008229 W JP2022008229 W JP 2022008229W WO 2022186122 A1 WO2022186122 A1 WO 2022186122A1
Authority
WO
WIPO (PCT)
Prior art keywords
bag
blood
tube
pressure
valve
Prior art date
Application number
PCT/JP2022/008229
Other languages
French (fr)
Japanese (ja)
Inventor
武田典彦
川口悟司
Original Assignee
テルモ株式会社
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 テルモ株式会社 filed Critical テルモ株式会社
Priority to JP2023503811A priority Critical patent/JPWO2022186122A1/ja
Publication of WO2022186122A1 publication Critical patent/WO2022186122A1/en

Links

Images

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/02Blood transfusion apparatus

Definitions

  • the present invention relates to a blood bag system used for separating blood components and a blood processing method.
  • Japanese Patent Application Laid-Open No. 2016-106012 discloses a first bag (parent bag) for containing blood and a second bag for containing blood components obtained by centrifuging the blood in the first bag (A blood bag system is disclosed that includes a secondary bag) and a third bag (medicine bag) containing an additive solution.
  • the blood bag system has a first tube connected to the first bag, a second tube connected to the second bag, and a third tube connected to the third bag. are connected to each other by branches (Y-connectors).
  • the blood bag system is set in a centrifugal separation transfer device by a user such as a medical professional, centrifuges blood to generate blood components, and separates a liquid containing blood components between the first to third bags.
  • a user such as a medical professional
  • centrifuges blood to generate blood components, and separates a liquid containing blood components between the first to third bags.
  • the user closes the flow path of the second tube with the first clamp and closes the flow path of the third tube with the second clamp. be done.
  • the user removes the blood bag system from the centrifugal transfer device, suspends it on the suspension base, and removes the second clamp from the third tube to transfer the additive solution from the third bag to the first bag. do.
  • the conventional blood bag system requires the user to operate two clamps, and the operation of the clamps is complicated, and there is a risk of erroneous operations such as removing the wrong clamp.
  • the present invention has been made in view of the above problems, and an object thereof is to provide a blood bag system and a blood processing method that facilitate clamp operation and prevent erroneous clamp operation.
  • One aspect of the following disclosure is a first bag for containing blood, a second bag for containing blood components obtained by centrifuging the blood in the first bag, and an additive solution containing a third bag connected to the first bag, a first tube connected to the first bag, a second tube connected to the second bag, a third tube connected to the third bag, and the first tube , a branch connecting the second tube and the third tube, and a flow path passing through the second tube or a flow path toward the second tube inside the branch, and closes the flow path and a pressure opening/closing valve that opens the flow path when the pressure in the flow path reaches or exceeds a predetermined opening pressure.
  • Another aspect is a method of processing blood using the blood bag system of the above aspect, comprising the steps of: separating blood in said first bag into blood components under the action of centrifugal force; transferring part of the blood components to the second bag by applying pressure to open the pressure on-off valve; and transferring the added solution in the third bag to the first bag by gravity flow. and a method for treating blood.
  • one of the conventional two clamps is a pressure opening/closing valve, so that the number of clamps can be reduced to only one. It is possible to prevent erroneous operation of the clamp due to
  • FIG. 1 is an explanatory diagram showing the overall configuration of a blood bag system and a centrifugal separation system according to a first embodiment
  • FIG. FIG. 4 is a plan view showing a unit set area of the centrifugal transfer device
  • FIG. 4 is a perspective view showing a state in which the branching portion of the blood bag system is set in the holder of the centrifugal transfer device
  • It is a sectional view of a pressure on-off valve.
  • 5 is a cutaway perspective view of the valve body of the pressure on-off valve of FIG. 4
  • FIG. FIG. 5 is a plan view showing a modification of the slit of the pressure on-off valve of FIG. 4
  • 2 is a flow chart showing a blood processing method using the blood bag system of FIG. 1;
  • FIG. 8A is an explanatory diagram showing the flow of blood components in the blood bag system during centrifugation
  • FIG. 8B is an explanatory diagram showing the flow of the additive solution during gravity flow transfer of the additive solution. It is sectional drawing which shows the modification (1) of the application site
  • a blood bag system 10 according to the first embodiment of the present invention is set in a centrifugal transfer device 12 as shown in FIG. 1 by a user such as a medical worker.
  • the centrifugal transfer device 12 centrifuges the blood in the blood bag system 10 to produce a plurality of types of blood components, and transfers the produced blood components to an appropriate bag 20 for storage.
  • a configuration including the blood bag system 10 and the centrifugal transfer device 12 is hereinafter referred to as a centrifugal separation system 14 .
  • the blood bag system 10 includes a pretreatment unit (not shown) used for blood collection before centrifugation, a separation processing unit 16 for generating blood components by centrifugation and individually storing them, and a pretreatment unit and separation processing unit 16. and a relay tube 18 connecting the .
  • the separation processing section 16 Prior to centrifugation, the separation processing section 16 is set in the centrifugal transfer device 12 in the state shown in FIG.
  • the pretreatment unit of the blood bag system 10 collects whole blood from a blood donor and removes blood components such as leukocytes from the whole blood. Therefore, the pretreatment unit has a blood collection needle, a blood collection bag, an initial blood flow bag, a filter (for example, a leukocyte removal filter) and the like (not shown), and is configured by connecting each member with a plurality of tubes 30 . Specifically, the preprocessing unit stores the first blood of the donor's whole blood collected through the blood collection needle in the initial blood flow bag, and then stores the remaining blood in the blood collection bag. Further, the preprocessing unit passes the whole blood stored in the blood collection bag through a filter to remove leukocytes in the filter. The blood from which leukocytes have been removed is transferred to the separation processing section 16 connected to the filter via the relay tube 18 .
  • a filter for example, a leukocyte removal filter
  • the separation processing section 16 of the blood bag system 10 has a plurality of bags 20 (blood bag 22, PPP bag 24, and drug solution bag 26) and is configured by connecting each bag 20 with a plurality of tubes 30.
  • the blood bag 22 is directly connected to the relay tube 18 connected to the pretreatment section in the state where the blood bag system 10 is provided as a product.
  • the blood bag 22 is a first bag having a first storage space 22a that stores blood from which leukocytes have been removed by passing through a filter during blood collection.
  • This blood bag 22 is set in the centrifugal separation transfer device 12 and centrifugal force is applied by the operation of the centrifugal separation transfer device 12 .
  • the blood removed from the blood bag 22 is centrifuged into blood components such as platelet poor plasma (PPP) and red blood cells (RBC) having different specific gravities. After centrifugation, the blood bag 22 stores only the remaining RBCs by transferring the PPP under the operation of the centrifugal transfer device 12 .
  • PPP platelet poor plasma
  • RBC red blood cells
  • the PPP bag 24 is a second bag (plasma bag) that stores the PPP in the second storage space 24a as the PPP is supplied from the blood bag 22.
  • the chemical solution bag 26 is a third bag in which a red blood cell preservation solution (hereinafter referred to as an additive solution) such as MAP solution, SAGM solution, OPTISOL, etc. is stored in advance in the third storage space 26a.
  • an additive solution such as MAP solution, SAGM solution, OPTISOL, etc.
  • the relay tubes 18 are sealed at predetermined intervals to form segment tubes 28.
  • a plurality of tubes 30 of the separation processing unit 16 are branched into a plurality of via branch connectors 32 (Y-shaped connectors: branch portions).
  • the plurality of tubes 30 includes a first tube 34 connecting the blood bag 22 and the branch connector 32, a second tube 36 connecting the PPP bag 24 and the branch connector 32, and a drug solution bag 26 and the branch connector 32.
  • a third tube 38 is included.
  • the first tube 34 has a first flow path 34a
  • the second tube 36 has a second flow path 36a
  • the third tube 38 has a third flow path 38a.
  • the branch connector 32 has a first port 32a to which the first tube 34 is connected, a second port 32b to which the second tube 36 is connected, and a third port 32c to which the third tube 38 is connected,
  • the first port 32a, the second port 32b, and the third port 32c are integrally molded.
  • the first port 32a, the second port 32b, and the third port 32c communicate with each other through an internal channel (not shown), thereby allowing the channels of the first tube 34, the second tube 36, and the third tube 38 to flow. communicate with each other.
  • a sealing member 40 that can be broken and the internal flow path is opened by the user's breaking operation.
  • a breakable sealing member 42 is provided at the end of the third tube 38 on the drug solution bag 26 side. The sealing members 40 and 42 block the first flow path 34a and the third flow path 38a, respectively, until the breaking operation is performed, and the blood in the blood bag 22 and the additive solution in the drug solution bag 26 are separated from the other bags 20. prevent it from being transferred to
  • the blood bag system 10 also includes a pressure on-off valve 100 provided on the second tube 36 near the branch connector 32 and a clamp 37 attached to the third tube 38 .
  • the clamp 37 is configured to open and close based on the user's operation and switch the third channel 38a of the third tube 38 between an open state and a closed state.
  • the pressure on-off valve 100 is closed in the initial state and closes the second flow path 36 a of the second tube 36 .
  • a fluid pressure equal to or higher than the opening pressure acts on the pressure on-off valve 100, the second flow path 36a is opened. Details of the pressure on-off valve 100 will be described later.
  • the centrifugal transfer device 12 in which the separation processing unit 16 of the blood bag system 10 is set includes a box-shaped base 44, a lid 46 capable of opening and closing the upper surface of the base 44, and a centrifugal drum 48 provided on the base 44.
  • the base 44 of the centrifugal transfer device 12 includes a motor (not shown) for rotating the centrifugal drum 48, a control unit 50 for controlling the operation of the centrifugal transfer device 12, and an operation display unit for user confirmation and operation. 52 are provided.
  • the centrifugal drum 48 has a plurality (six) of unit setting areas 54 in which the separation processing units 16 can be set.
  • One unit set area 54 has a height longer than the longitudinal length of the bag 20 and is set within a range of 60° with respect to the center of rotation of the centrifugal drum 48 .
  • the six unit set areas 54 are arranged circumferentially without gaps to form the centrifugal drum 48, which is an annular structure.
  • the unit set area 54 includes a blood bag pocket 56 containing the blood bag 22, a PPP bag pocket 58 containing the PPP bag 24, and a medical solution bag pocket 60 containing the medical solution bag 26. It is provided at a radially outer position of the centrifugal drum 48 .
  • the blood bag pocket 56 is provided in the circumferential central portion of the unit set area 54 and has a volume larger than that of the PPP bag pocket 58 and the drug solution bag pocket 60 .
  • the PPP bag pocket 58 and the drug solution bag pocket 60 are provided side by side in the circumferential direction outside the blood bag pocket 56 in the radial direction.
  • the upper surface 54a of the unit set area 54 is configured to arrange and hold the plurality of tubes 30 of the blood bag system 10.
  • a portion of the first tube 34 and the segment tube 28 are arranged in a central region 54a1 radially inside the blood bag pocket 56 on the upper surface 54a.
  • a lid 62 for opening and closing the opening of the blood bag pocket 56 is provided in the central region 54a1. Further, at the arrangement position of the first tube 34 closed by the lid 62, a part of the breaking portion 64 that breaks the sealing member 40 and a sensor 66 that detects the state of the blood flowing through the first tube 34 are provided. It is
  • a portion of the first tube 34, a portion of the branch connector 32, a second tube 36 and a portion of the third tube 38 passing through the central region 54a1 are arranged in the left region 54a2 of the upper surface 54a.
  • the left area 54a2 includes a holder 150 for holding the branch connector 32, a PPP clamp 70 for opening and closing the second flow path 36a of the second tube 36, and a chemical solution for opening and closing the third flow path 38a of the third tube 38.
  • a clamp 72 is provided.
  • a right region 54a3 of the upper surface 54a is provided with a segment pocket 74 for accommodating a plurality of closed tubes 28a (see FIG. 1) of the segment tube 28. As shown in FIG.
  • a tube holding portion 76 that protrudes upward from the upper surface 54a is provided radially outward of the PPP bag pocket 58 and the chemical solution bag pocket 60 of the unit set area 54 .
  • the tube holding portion 76 has a guide groove portion 78 in which the second tube 36 is arranged.
  • the unit set area 54 also includes a slider 82 radially inside the blood bag pocket 56 for pressing the blood bag 22 after centrifugation.
  • the slider 82 advances and retreats along the radial direction of the centrifugal drum 48 under the control of the controller 50 (see FIG. 1).
  • the user puts the blood bag 22 storing the removed blood into the blood bag pocket 56 , the empty PPP bag 24 into the PPP bag pocket 58 , and the drug solution bag 26 storing the drug solution into the drug solution bag pocket 60 . are accommodated in each.
  • the unit set area 54 centrifuges the removed blood in the blood bag 22 by rotating the centrifugal drum 48 , and advances the slider 82 to press the blood bag 22 after the centrifugal separation.
  • the PPP produced in the blood bag 22 by centrifugation is transferred to the PPP bag 24, and the RBC remains in the blood bag 22 after the PPP is transferred.
  • the blood bag system 10 is removed from the centrifuge transfer device 12 by the user.
  • FIG. 1 the pressure on-off valve 100 of the blood bag system 10 according to this embodiment will be described with reference to FIGS. 3 to 6.
  • FIG. 1 the pressure on-off valve 100 of the blood bag system 10 according to this embodiment will be described with reference to FIGS. 3 to 6.
  • the pressure on-off valve 100 is attached to the second tube 36 of the blood bag system 10 and closes the second flow path 36a. Furthermore, the pressure on-off valve 100 is configured to be opened by the fluid pressure when the blood bag 22 is pressurized by the centrifugal transfer device 12 . The pressure on-off valve 100 is also configured to close again when the fluid pressure drops.
  • the pressure on-off valve 100 includes a cylindrical housing 84 made of resin material or metal material.
  • a first connection port 86 and a second connection port 88 to which the second tube 36 is connected are provided at one end and the other end of the housing 84 of the pressure on-off valve 100 .
  • a hollow portion 84 a is formed inside the housing 84 .
  • a valve body 90 is arranged in the hollow portion 84a.
  • the valve body 90 is made of a soft elastic material such as rubber or elastomer.
  • the valve body 90 includes a disk-shaped valve body 92 and a support portion 94 projecting from the peripheral edge portion of the valve body 92 to one side (axial direction) in the thickness direction of the valve body 92 . have.
  • the support portion 94 is formed to protrude in the shape of a circular wall along the peripheral portion of the valve body 92 .
  • the support portion 94 is in close contact with the inner wall of the housing 84 and prevents the valve body 90 from being displaced even when pressure is applied.
  • the valve body 92 is formed in the same shape as the cross section of the hollow portion 84a, and divides the hollow portion 84a into an area on the first connection port 86 side and an area on the second connection port 88 side in an air-tight and liquid-tight manner.
  • a slit 96 is formed in the central portion of the valve body 92 and is a linear cut extending through the valve body 92 in the thickness direction.
  • the slit 96 is formed in a linear shape passing through the central axis of the disk-shaped valve body 92 when viewed from the front.
  • the slit 96 is tightly closed when no pressure is applied, and prevents the passage of fluid.
  • the valve main body 92 is elastically deformed when pressure is applied, and a gap is generated in the slit 96 so that the valve body 92 can be deformed into an open state in which fluid is allowed to pass.
  • the pressure (opening pressure) when the valve body 90 is opened can be appropriately set according to the thickness of the valve body 92 . As the thickness of the valve body 92 increases, the opening pressure increases, and as the thickness of the valve body 92 decreases, the opening pressure decreases.
  • the opening pressure of the valve body 90 is preferably set to at least a value that does not open due to the pressure when the added solution in the drug solution bag 26 is transferred to the blood bag 22 under gravity flow.
  • the pressure generated when the chemical solution bag 26 naturally flows down varies depending on the difference in height between the chemical solution bag 26 and the valve body 90, but is approximately 1.7 kPa.
  • the pressure generated when the drug solution bag 26 was lightly gripped was about 3.3 kPa, and the pressure generated when the drug solution bag 26 was gripped strongly was about 8 kPa.
  • the opening pressure should be higher than 1.7 kPa. ) is preferred.
  • the pressure of the blood bag 22 of the centrifugal separation transfer device 12 prevents the valve body 90 from opening.
  • the PPP bag 24 is operated by the user to remove air bubbles after the plasma component is transferred. If the opening pressure of the valve body 90 is too high, it becomes difficult for the user to remove air bubbles. Therefore, the upper limit of the opening pressure is more preferably equal to or less than the pressure (eg, 8 kPa) that can be generated by gripping the PPP bag 24 strongly. is preferably A pressure of 3.3 kPa to 6 kPa is more preferable from the viewpoint of preventing mixing of the plasma component and the additive solution and removing air.
  • the number of slits 96 is not limited to one, and a plurality of slits 96 may be provided radially around the central axis as shown in the modified example of FIG.
  • the above pressure on-off valve 100 is connected to the middle of the second tube 36 as shown in FIG. Although not particularly limited, the pressure on-off valve 100 can be connected to the second tube 36 near the branch connector 32 .
  • the holder 150 has a connector holding portion 152 holding the branch connector 32 and a clamp holding portion 154 holding the clamp 37 .
  • the pressure on-off valve 100 is arranged near the holder 150 together with the branch connector 32 when the blood bag system 10 is set on the centrifugal transfer device 12 .
  • the connector holding portion 152 is formed in a columnar shape, has a Y-shaped holding groove 152a cut from the upper end portion to a predetermined depth, and is configured so that the branch connector 32 can be fitted from the outside.
  • the valve body 92 is formed by injection molding or the like separately from the bag 20 and the tube 30. By arranging the valve body 92 in the housing 84 and connecting the first connection port 86 and the second connection port 88, the pressure on-off valve 100 is manufactured.
  • the pressure on/off valve 100 is connected to the second tube 36 and the clamp 37 is attached to the third tube 38 .
  • the second tube 36 and the third tube 38 are then secured to the branch connector 32 . Thereby, the blood bag system 10 having the pressure on-off valve 100 is formed.
  • the blood bag system 10 is basically configured as described above, and the operation thereof will be described below together with the blood processing method.
  • the blood processing method using the blood bag system 10 includes a blood collection step (step S1), a leukocyte removal step (step S2), an apparatus setting step (step S3), a centrifugation step (step S4), a plasma component transfer step (step S5), an apparatus extraction step (step S6), a suspension step (step S7), an additive solution injection step (step S8), and a seal separation step (step S9). be done.
  • step S1 the user collects the donor's whole blood using the blood collection needle of the preprocessing unit (not shown) and stores it in a blood collection bag.
  • step S2 the user moves whole blood from the blood collection bag to the blood bag 22. FIG. At this time, the whole blood passes through the filter, and the blood bag 22 stores the removed blood from which leukocytes have been removed from the whole blood.
  • the user separates the separation processing section 16 of the blood bag system 10 from the preprocessing section and sets it on the centrifugal transfer device 12 in the device setting step (step S3).
  • the user stores the blood bag 22 in the blood bag pocket 56 of the unit setting area 54, and along the predetermined path on the upper surface 54a of the unit setting area 54, the first tube 34 and the second tube. 36, and the third tube 38 are set.
  • the first tube 34 is routed along a predetermined path in the central area 54a1 and then directed toward the left area 54a2. Further, the user manages the first tube 34, the second tube 36, and the third tube 38 in the left area 54a2, and holds the branch connector 32 and the clamp 37 in the holder 150.
  • the second tube 36 extends outward in the centrifugal direction from the branch connector 32 through the left area 54 a 2 and is arranged to pass through the PPP clamp 70 . Further, the second tube 36 is accommodated in the guide groove portion 78 of the tube holding portion 76 radially outside the medical solution bag pocket 60 .
  • the third tube 38 also extends outward in the centrifugal direction from the branch connector 32 through the left region 54 a 2 and is arranged to pass through the drug solution clamp 72 . Then, the user stores the PPP bag 24 connected to the second tube 36 in the PPP bag pocket 58 and stores the drug solution bag 26 connected to the third tube 38 in the drug solution bag pocket 60 . This completes the setting of the blood bag system 10 to the centrifugal transfer device 12 .
  • the user attaches the branch connector 32 to the connector holding portion 152 of the holder 150, and at the same time inserts the clamp 37 into the arrangement space 162 between the holding plate 160 and the opposing wall 161 of the holder 150. do.
  • the pressure on-off valve 100 closes the second flow path 36a of the second tube 36. As shown in FIG.
  • the centrifugal transfer device 12 rotates the centrifugal drum 48 under the control of the control unit 50, thereby separating the removed blood from the blood bag 22 into PPP, RBC, etc. having different specific gravities. Centrifuge into blood components. During centrifugation, the second tube 36 and the third tube 38 are closed by the PPP clamp 70 and the drug solution clamp 72 (see FIG. 2 for both), thereby suppressing the flow of blood components.
  • step S5 the centrifugal transfer device 12 releases only the PPP clamp 70 and presses the blood bag 22 with the slider 82 .
  • the pressure on-off valve 100 provided on the second tube 36 is opened.
  • the PPP in the blood bag 22 then flows through the first tube 34 , the branch connector 32 and the second tube 36 in order and flows into the PPP bag 24 .
  • step S5 After the plasma component transfer step (step S5), the pressure on-off valve 100 is closed as the pressure in the second channel 36a decreases. Therefore, the second flow path 36a and the third flow path 38a return to the blocked state.
  • the centrifugal transfer device 12 retracts the slider 82 and opens the drug solution clamp 72 (see FIG. 2) to centrifuge the blood bag system 10. It is made separable from the transfer device 12 .
  • the user closes the third channel 38 a of the third tube 38 with the clamp 37 .
  • the user takes out the blood bag system 10 .
  • the suspending step step S7, the user suspends the drug solution bag 26 on a stand (not shown) and further arranges the blood bag 22 below the drug solution bag 26 in the direction of gravity.
  • step S8 the user opens the third tube 38 and breaks the sealing member 42, so that the additive solution in the drug solution bag 26 is poured into the blood as shown in FIG. 8B.
  • Supply bag 22 the user opens the third channel 38 a by deforming the clamp 37 .
  • the added solution in the drug solution bag 26 is injected into the blood bag 22 through the third tube 38 and the first tube 34 .
  • the pressure on/off valve 100 of the second tube 36 receives a pressure corresponding to the difference in height from the liquid medicine bag 26, but since it is lower than the opening pressure of the pressure on/off valve 100, the pressure on/off valve 100 is kept closed. be Therefore, according to this embodiment, it is possible to prevent the additive solution from entering the PPP bag 24 without providing the clamp 37 on the second tube 36 .
  • step S9 after the additive solution injection step (step S8), the user seals and cuts the first tube 34 at an appropriate position.
  • the blood bag 22 is separated from the blood bag system 10 with the RBCs containing the added solution stored therein.
  • the user seals and cuts the PPP bag 24 side of the pressure shut-off valve 100 in the second tube 36 . This separates the PPP bag 24 from the blood bag system 10 with the PPP stored therein. The remaining blood bag system 10 including the pressure on-off valve 100 is discarded as appropriate.
  • valve body 92 is arranged in the second flow path 36a of the second tube 36A, and the pressure on-off valve 100 is connected to the second tube 36A.
  • the valve body 92 is arranged in the second flow path 36a of the second tube 36A, and the pressure on-off valve 100 is connected to the second tube 36A. may be integrated with
  • valve body 92 may be arranged inside the branch connector 32A, and the pressure on-off valve 100 may be integrated with the branch connector 32A.
  • the blood bag system 10 of this embodiment has the following effects.
  • the blood bag system 10 of this embodiment includes a first bag (for example, a blood bag 22) for containing blood, and a first bag for containing blood components obtained by centrifuging the blood in the first bag.
  • 2 bags for example, PPP bag 24
  • a third bag for example, drug solution bag 26
  • a branch portion for example, a branch connector 32
  • the first tube 34, the second tube 36 and the third tube 38 and the second tube 36 provided on the flow path (for example, the second flow path 36a) passing through or on the flow path toward the second tube 36 inside the branch, closing the flow path and increasing the pressure in the flow path to a predetermined opening pressure or higher
  • a pressure on-off valve 100 that opens the flow path.
  • the pressure on-off valve 100 may be provided on the flow path passing through the third tube 38 or on the flow path toward the third tube 38 at the branch.
  • the pressure on-off valve 100 is provided in the second tube 36, and the opening pressure of the pressure on-off valve 100 is the pressure of the additive solution that acts due to the drop between the third bag and the pressure on-off valve 100.
  • the pressure opening/closing valve 100 is kept closed during the operation of injecting the additive solution from the third bag to the first bag, which is performed after the centrifugation step.
  • the addition solution can be prevented from flowing into the second tube 36 side. That is, it becomes unnecessary to attach the clamp 37 to the second tube 36 . This improves workability for the user.
  • the opening pressure of the pressure on-off valve 100 may be 3.3 kPa or more.
  • the opening pressure of the pressure on-off valve 100 may be 200 kPa or less. With this configuration, the pressure opening/closing valve 100 is reliably opened when the blood components are transferred from the first bag to the second bag, so that the blood components can be reliably transferred.
  • the pressure on-off valve 100 may be provided inside the branch. This configuration simplifies the configuration of the device and improves the handleability.
  • the pressure on-off valve 100 may be provided inside the second tube 36 or the third tube 38 . This configuration simplifies the configuration of the device and improves the handleability.
  • the pressure on-off valve 100 includes a plate-like (for example, disk-like) valve body 92 that closes the flow path, a support portion 94 that contacts the wall surface of the flow path, and a valve body 92. and a slit 96 passing through the central axis and through the valve body 92 in the thickness direction.
  • a plurality of slits 96 may be radially provided.
  • the axial thickness of the channel of the valve body 92 may be thinner than the axial thickness of the channel of the support portion 94 . According to this configuration, the valve body 92 can be deformed and opened and closed according to the pressure.
  • the pressure on-off valve 100 may be made of rubber or elastomer.
  • the blood processing method of the present embodiment is a method of processing blood using the above-described blood bag system 10, comprising the step of separating the blood in the first bag into blood components under the action of centrifugal force; by pressurizing to open the pressure on-off valve 100 to transfer a portion of the blood components to the second bag; and transferring the additive solution in the third bag to the first bag by gravity flow. .
  • the user can concentrate on opening and closing one clamp 37, thereby preventing erroneous opening and closing.

Abstract

This blood bag system (10) and blood treatment method has a first bag (22) for containing blood, a second bag (24) for containing a blood component obtained by centrifugally separating the blood in the first bag, a third bag (26) in which an additive solution is contained, a first tube (34) connected to the first bag, a second tube (36) connected to the second bag, a third tube (38) connected to the third bag, and a branch part (32) linking the above elements. The second tube (36) is provided with a pressure opening/closing valve (100) that opens when the pressure reaches or exceeds a prescribed opening pressure.

Description

血液バッグシステム及び血液の処理方法Blood bag system and blood processing method
 本発明は、血液成分の分離に使用する血液バッグシステム及び血液の処理方法に関する。 The present invention relates to a blood bag system used for separating blood components and a blood processing method.
 特開2016-106012号公報には、血液を収容するための第1バッグ(親バッグ)と、第1バッグ内の血液を遠心分離して得られた血液成分を収容するための第2バッグ(子バッグ)と、添加溶液を収容した第3バッグ(薬液バッグ)とを備える血液バッグシステムが開示されている。血液バッグシステムは、第1バッグに接続される第1チューブと、第2バッグに接続される第2チューブと、第3バッグに接続される第3チューブとを有し、第1~第3チューブは、分岐部(Y型コネクタ)によって互いに連結されている。 Japanese Patent Application Laid-Open No. 2016-106012 discloses a first bag (parent bag) for containing blood and a second bag for containing blood components obtained by centrifuging the blood in the first bag ( A blood bag system is disclosed that includes a secondary bag) and a third bag (medicine bag) containing an additive solution. The blood bag system has a first tube connected to the first bag, a second tube connected to the second bag, and a third tube connected to the third bag. are connected to each other by branches (Y-connectors).
 血液バッグシステムは、医療従事者等のユーザにより遠心分離移送装置にセットされることで、血液を遠心分離して血液成分を生成し、また第1~第3バッグ間において血液成分を含む液体を移送する遠心分離システムを構成する。遠心分離システムは、第1バッグから第2バッグへの血液成分の移送後に、ユーザにより第1のクランプによって第2チューブの流路が閉塞され、第2のクランプによって第3チューブの流路が閉塞される。この状態で、ユーザは、遠心分離移送装置から血液バッグシステムを取り外して懸架台に懸架し、さらに第2のクランプを第3チューブから外すことで、第3バッグから第1バッグに添加溶液を移送する。 The blood bag system is set in a centrifugal separation transfer device by a user such as a medical professional, centrifuges blood to generate blood components, and separates a liquid containing blood components between the first to third bags. Configure the transfer centrifuge system. In the centrifugation system, after the blood components are transferred from the first bag to the second bag, the user closes the flow path of the second tube with the first clamp and closes the flow path of the third tube with the second clamp. be done. In this state, the user removes the blood bag system from the centrifugal transfer device, suspends it on the suspension base, and removes the second clamp from the third tube to transfer the additive solution from the third bag to the first bag. do.
 従来の、血液バッグシステムは、ユーザが2つのクランプを操作する必要があり、クランプの操作が煩雑であると共に、誤ったクランプを外す等の誤操作を生じるおそれがある。 The conventional blood bag system requires the user to operate two clamps, and the operation of the clamps is complicated, and there is a risk of erroneous operations such as removing the wrong clamp.
 本発明は、上記の課題に鑑みたものであり、クランプの操作を容易にし、クランプの誤操作を防止できる血液バッグシステム及び血液の処理方法を提供することを目的とする。 The present invention has been made in view of the above problems, and an object thereof is to provide a blood bag system and a blood processing method that facilitate clamp operation and prevent erroneous clamp operation.
 以下の開示の一観点は、血液を収容するための第1バッグと、前記第1バッグ内の血液を遠心分離して得られた血液成分を収容するための第2バッグと、添加溶液が収容された第3バッグと、前記第1バッグに接続される第1チューブと、前記第2バッグに接続される第2チューブと、前記第3バッグに接続される第3チューブと、前記第1チューブ、前記第2チューブ及び前記第3チューブを連結する分岐部と、前記第2チューブを通る流路上又は前記分岐部の内部の前記第2チューブに向かう流路上に設けられ、前記流路を閉塞すると共に、前記流路内の圧力が所定の開通圧力以上となると前記流路を開通させる圧力開閉弁と、を備える血液バッグシステムにある。 One aspect of the following disclosure is a first bag for containing blood, a second bag for containing blood components obtained by centrifuging the blood in the first bag, and an additive solution containing a third bag connected to the first bag, a first tube connected to the first bag, a second tube connected to the second bag, a third tube connected to the third bag, and the first tube , a branch connecting the second tube and the third tube, and a flow path passing through the second tube or a flow path toward the second tube inside the branch, and closes the flow path and a pressure opening/closing valve that opens the flow path when the pressure in the flow path reaches or exceeds a predetermined opening pressure.
 別の一観点は、上記観点の血液バッグシステムを用いた血液の処理方法であって、遠心力の作用下で前記第1バッグの血液を血液成分に分離するステップと、前記第1バッグを加圧することにより、前記圧力開閉弁を開放させて血液成分の一部を前記第2バッグに移送するステップと、前記第3バッグの添加溶液を自然流下により前記第1バッグに移送するステップと、を有する、血液の処理方法にある。 Another aspect is a method of processing blood using the blood bag system of the above aspect, comprising the steps of: separating blood in said first bag into blood components under the action of centrifugal force; transferring part of the blood components to the second bag by applying pressure to open the pressure on-off valve; and transferring the added solution in the third bag to the first bag by gravity flow. and a method for treating blood.
 上記観点の血液バッグシステム及び血液の処理方法によれば、従来2つのクランプの一方を圧力開閉弁とすることで、クランプを1つのみに減らすことができるため、操作が容易になると共に、ユーザによるクランプの誤操作を防止できる。 According to the blood bag system and the blood processing method of the above viewpoint, one of the conventional two clamps is a pressure opening/closing valve, so that the number of clamps can be reduced to only one. It is possible to prevent erroneous operation of the clamp due to
第1実施形態に係る血液バッグシステム及び遠心分離システムの全体構成を示す説明図である。1 is an explanatory diagram showing the overall configuration of a blood bag system and a centrifugal separation system according to a first embodiment; FIG. 遠心分移送装置の単位セットエリアを示す平面図である。FIG. 4 is a plan view showing a unit set area of the centrifugal transfer device; 血液バッグシステムの分岐部を遠心分離移送装置のホルダにセットした状態を示す斜視図である。FIG. 4 is a perspective view showing a state in which the branching portion of the blood bag system is set in the holder of the centrifugal transfer device; 圧力開閉弁の断面図である。It is a sectional view of a pressure on-off valve. 図4の圧力開閉弁の弁体の切断斜視図である。5 is a cutaway perspective view of the valve body of the pressure on-off valve of FIG. 4; FIG. 図4の圧力開閉弁のスリットの変形例を示す平面図である。FIG. 5 is a plan view showing a modification of the slit of the pressure on-off valve of FIG. 4; 図1の血液バッグシステムを用いた血液の処理方法を示すフローチャートである。2 is a flow chart showing a blood processing method using the blood bag system of FIG. 1; 図8Aは、遠心分離の際の血液バッグシステムの血液成分の流れを示す説明図であり、図8Bは添加溶液を自然流下で移送する際の添加溶液の流れを示す説明図である。FIG. 8A is an explanatory diagram showing the flow of blood components in the blood bag system during centrifugation, and FIG. 8B is an explanatory diagram showing the flow of the additive solution during gravity flow transfer of the additive solution. 圧力開閉弁の適用部位の変形例(その1)を示す断面図である。It is sectional drawing which shows the modification (1) of the application site|part of a pressure on-off valve. 圧力開閉弁の適用部位の変形例(その2)を示す断面図である。It is sectional drawing which shows the modification (2) of the application site|part of a pressure on-off valve.
 以下、本発明について好適な実施形態を挙げ、添付の図面を参照して詳細に説明する。 Hereinafter, preferred embodiments of the present invention will be cited and described in detail with reference to the accompanying drawings.
(第1実施形態)
 本発明の第1実施形態に係る血液バッグシステム10は、医療従事者等のユーザにより、図1に示すように遠心分離移送装置12にセットされる。遠心分離移送装置12は、血液バッグシステム10の血液を遠心分離して複数種類の血液成分を生成し、生成した血液成分を適宜のバッグ20に移送して保存する。以下では、血液バッグシステム10と遠心分離移送装置12とを含む構成を遠心分離システム14という。
(First embodiment)
A blood bag system 10 according to the first embodiment of the present invention is set in a centrifugal transfer device 12 as shown in FIG. 1 by a user such as a medical worker. The centrifugal transfer device 12 centrifuges the blood in the blood bag system 10 to produce a plurality of types of blood components, and transfers the produced blood components to an appropriate bag 20 for storage. A configuration including the blood bag system 10 and the centrifugal transfer device 12 is hereinafter referred to as a centrifugal separation system 14 .
 血液バッグシステム10は、遠心分離前の採血に使用される図示しない前処理部と、遠心分離により血液成分を生成して個別に保存する分離処理部16と、前処理部と分離処理部16とを接続する中継チューブ18とを有する。分離処理部16は、遠心分離前に、前処理部に繋がる中継チューブ18が切断されて図1に示される状態となり、遠心分離移送装置12にセットされる。 The blood bag system 10 includes a pretreatment unit (not shown) used for blood collection before centrifugation, a separation processing unit 16 for generating blood components by centrifugation and individually storing them, and a pretreatment unit and separation processing unit 16. and a relay tube 18 connecting the . Prior to centrifugation, the separation processing section 16 is set in the centrifugal transfer device 12 in the state shown in FIG.
 血液バッグシステム10の前処理部は、供血者から全血を採取し、また全血から白血球等の血液成分を除去する。このため前処理部は、図示しない採血針、採血バッグ、初流血バッグ、フィルタ(例えば、白血球除去フィルタ)等を有し、複数のチューブ30により各部材を接続することで構成される。具体的には、前処理部は、採血針を通して採取したドナーの全血のうち最初の血液を初流血バッグに貯留し、その後に残りの血液を採血バッグに貯留する。さらに前処理部は、採血バッグに貯留された全血をフィルタに通すことで、フィルタにおいて白血球を除去する。そして白血球除去後の血液は、中継チューブ18を介してフィルタに接続された分離処理部16に移送される。 The pretreatment unit of the blood bag system 10 collects whole blood from a blood donor and removes blood components such as leukocytes from the whole blood. Therefore, the pretreatment unit has a blood collection needle, a blood collection bag, an initial blood flow bag, a filter (for example, a leukocyte removal filter) and the like (not shown), and is configured by connecting each member with a plurality of tubes 30 . Specifically, the preprocessing unit stores the first blood of the donor's whole blood collected through the blood collection needle in the initial blood flow bag, and then stores the remaining blood in the blood collection bag. Further, the preprocessing unit passes the whole blood stored in the blood collection bag through a filter to remove leukocytes in the filter. The blood from which leukocytes have been removed is transferred to the separation processing section 16 connected to the filter via the relay tube 18 .
 血液バッグシステム10の分離処理部16は、複数のバッグ20(血液バッグ22、PPPバッグ24及び薬液バッグ26)を有し、複数のチューブ30により各バッグ20を接続することで構成される。 The separation processing section 16 of the blood bag system 10 has a plurality of bags 20 (blood bag 22, PPP bag 24, and drug solution bag 26) and is configured by connecting each bag 20 with a plurality of tubes 30.
 血液バッグ22は、血液バッグシステム10の製品提供状態で、前処理部と繋がる中継チューブ18に直接接続されている。血液バッグ22は、採血時においてフィルタを経由することで白血球が除去された血液を貯留する第1貯留空間22aを有する第1バッグである。この血液バッグ22は、遠心分離移送装置12にセットされ、遠心分離移送装置12の動作により遠心力が付与される。これにより血液バッグ22の除去血液は、比重の異なる乏血小板血漿(platelet poor plasma:PPP)、濃厚赤血球(red blood cells:RBC)等の血液成分に遠心分離される。そして、血液バッグ22は、遠心分離後に遠心分離移送装置12の動作下に、PPPが移送されることで、残留したRBCのみを貯留する。 The blood bag 22 is directly connected to the relay tube 18 connected to the pretreatment section in the state where the blood bag system 10 is provided as a product. The blood bag 22 is a first bag having a first storage space 22a that stores blood from which leukocytes have been removed by passing through a filter during blood collection. This blood bag 22 is set in the centrifugal separation transfer device 12 and centrifugal force is applied by the operation of the centrifugal separation transfer device 12 . As a result, the blood removed from the blood bag 22 is centrifuged into blood components such as platelet poor plasma (PPP) and red blood cells (RBC) having different specific gravities. After centrifugation, the blood bag 22 stores only the remaining RBCs by transferring the PPP under the operation of the centrifugal transfer device 12 .
 PPPバッグ24は、血液バッグ22からPPPが供給されることで、このPPPを第2貯留空間24aに保存する第2バッグ(血漿バッグ)である。一方、薬液バッグ26は、MAP液、SAGM液、OPTISOL等の赤血球保存液(以下、添加溶液という)を第3貯留空間26aに予め収容している第3バッグである。 The PPP bag 24 is a second bag (plasma bag) that stores the PPP in the second storage space 24a as the PPP is supplied from the blood bag 22. On the other hand, the chemical solution bag 26 is a third bag in which a red blood cell preservation solution (hereinafter referred to as an additive solution) such as MAP solution, SAGM solution, OPTISOL, etc. is stored in advance in the third storage space 26a.
 また、分離処理部16は、遠心分離移送装置12にセットされる前に、中継チューブ18が所定間隔毎にシールされてセグメントチューブ28が形成される。 In addition, before the separation processing unit 16 is set in the centrifugal transfer device 12, the relay tubes 18 are sealed at predetermined intervals to form segment tubes 28.
 分離処理部16の複数のチューブ30は、分岐コネクタ32(Y型コネクタ:分岐部)を介して複数に分岐している。詳細には、複数のチューブ30は、血液バッグ22と分岐コネクタ32を接続する第1チューブ34、PPPバッグ24と分岐コネクタ32を接続する第2チューブ36、及び薬液バッグ26と分岐コネクタ32を接続する第3チューブ38を含む。第1チューブ34は第1流路34aを有し、第2チューブ36は第2流路36aを有し、第3チューブ38は第3流路38aを有する。 A plurality of tubes 30 of the separation processing unit 16 are branched into a plurality of via branch connectors 32 (Y-shaped connectors: branch portions). Specifically, the plurality of tubes 30 includes a first tube 34 connecting the blood bag 22 and the branch connector 32, a second tube 36 connecting the PPP bag 24 and the branch connector 32, and a drug solution bag 26 and the branch connector 32. A third tube 38 is included. The first tube 34 has a first flow path 34a, the second tube 36 has a second flow path 36a, and the third tube 38 has a third flow path 38a.
 また、分岐コネクタ32は、第1チューブ34が接続される第1ポート32a、第2チューブ36が接続される第2ポート32b、及び第3チューブ38が接続される第3ポート32cを有し、第1ポート32a、第2ポート32b、第3ポート32cが一体成形されている。第1ポート32a、第2ポート32b、第3ポート32cは、図示しない内部流路により互いに連通しており、これにより第1チューブ34、第2チューブ36、及び第3チューブ38の各流路を互いに連通している。 Also, the branch connector 32 has a first port 32a to which the first tube 34 is connected, a second port 32b to which the second tube 36 is connected, and a third port 32c to which the third tube 38 is connected, The first port 32a, the second port 32b, and the third port 32c are integrally molded. The first port 32a, the second port 32b, and the third port 32c communicate with each other through an internal channel (not shown), thereby allowing the channels of the first tube 34, the second tube 36, and the third tube 38 to flow. communicate with each other.
 第1チューブ34の血液バッグ22側の端部には、破断可能であり、ユーザによる破断操作に伴い内部流路が開通する封止部材40が設けられている。同様に、第3チューブ38の薬液バッグ26側の端部には、破断可能な封止部材42が設けられている。封止部材40、42は、破断操作が行われるまで第1流路34a及び第3流路38aの各々を遮断し、血液バッグ22内の血液や薬液バッグ26内の添加溶液を他のバッグ20に移送することを防止する。 At the end of the first tube 34 on the blood bag 22 side, there is provided a sealing member 40 that can be broken and the internal flow path is opened by the user's breaking operation. Similarly, a breakable sealing member 42 is provided at the end of the third tube 38 on the drug solution bag 26 side. The sealing members 40 and 42 block the first flow path 34a and the third flow path 38a, respectively, until the breaking operation is performed, and the blood in the blood bag 22 and the additive solution in the drug solution bag 26 are separated from the other bags 20. prevent it from being transferred to
 また、血液バッグシステム10は、分岐コネクタ32の近傍位置の第2チューブ36に設けられた圧力開閉弁100と、第3チューブ38に取り付けられたクランプ37と、を備える。クランプ37は、ユーザの操作に基づいて開閉し、第3チューブ38の第3流路38aを開放状態又は閉塞状態に切り換え可能に構成される。圧力開閉弁100は、初期状態では閉塞しており第2チューブ36の第2流路36aを閉塞している。圧力開閉弁100に、開通圧力以上の流体圧が作用すると、第2流路36aを開通させる。圧力開閉弁100の詳細については、後述する。 The blood bag system 10 also includes a pressure on-off valve 100 provided on the second tube 36 near the branch connector 32 and a clamp 37 attached to the third tube 38 . The clamp 37 is configured to open and close based on the user's operation and switch the third channel 38a of the third tube 38 between an open state and a closed state. The pressure on-off valve 100 is closed in the initial state and closes the second flow path 36 a of the second tube 36 . When a fluid pressure equal to or higher than the opening pressure acts on the pressure on-off valve 100, the second flow path 36a is opened. Details of the pressure on-off valve 100 will be described later.
 一方、血液バッグシステム10の分離処理部16がセットされる遠心分離移送装置12は、箱状の基体44と、基体44の上面を開閉可能な蓋46と、基体44に設けられる遠心ドラム48とを備える。また、遠心分離移送装置12の基体44には、遠心ドラム48を回転させる図示しないモータ、遠心分離移送装置12の動作を制御する制御部50、及びユーザが確認及び操作を行うための操作表示部52が設けられている。 On the other hand, the centrifugal transfer device 12 in which the separation processing unit 16 of the blood bag system 10 is set includes a box-shaped base 44, a lid 46 capable of opening and closing the upper surface of the base 44, and a centrifugal drum 48 provided on the base 44. Prepare. The base 44 of the centrifugal transfer device 12 includes a motor (not shown) for rotating the centrifugal drum 48, a control unit 50 for controlling the operation of the centrifugal transfer device 12, and an operation display unit for user confirmation and operation. 52 are provided.
 遠心ドラム48は、分離処理部16をセット可能な単位セットエリア54を複数(6つ)有する。1つの単位セットエリア54は、その高さがバッグ20の長手方向長さよりも長く、また遠心ドラム48の回転中心に対し60°の範囲に設定されている。つまり、6つの単位セットエリア54は、周方向に沿って隙間なく並ぶことで、環状の構造部である遠心ドラム48を構成する。 The centrifugal drum 48 has a plurality (six) of unit setting areas 54 in which the separation processing units 16 can be set. One unit set area 54 has a height longer than the longitudinal length of the bag 20 and is set within a range of 60° with respect to the center of rotation of the centrifugal drum 48 . In other words, the six unit set areas 54 are arranged circumferentially without gaps to form the centrifugal drum 48, which is an annular structure.
 図2に示すように、単位セットエリア54は、血液バッグ22を収容する血液バッグポケット56と、PPPバッグ24を収容するPPPバッグポケット58と、薬液バッグ26を収容する薬液バッグポケット60と、を遠心ドラム48の径方向外側位置に備える。 As shown in FIG. 2, the unit set area 54 includes a blood bag pocket 56 containing the blood bag 22, a PPP bag pocket 58 containing the PPP bag 24, and a medical solution bag pocket 60 containing the medical solution bag 26. It is provided at a radially outer position of the centrifugal drum 48 .
 血液バッグポケット56は、単位セットエリア54の周方向中央部に設けられ、PPPバッグポケット58や薬液バッグポケット60よりも大きな容積を有する。PPPバッグポケット58と薬液バッグポケット60は、血液バッグポケット56よりも径方向外側において周方向に並んで設けられる。 The blood bag pocket 56 is provided in the circumferential central portion of the unit set area 54 and has a volume larger than that of the PPP bag pocket 58 and the drug solution bag pocket 60 . The PPP bag pocket 58 and the drug solution bag pocket 60 are provided side by side in the circumferential direction outside the blood bag pocket 56 in the radial direction.
 また、単位セットエリア54の上面54aは、血液バッグシステム10の複数のチューブ30を配置し保持するように構成されている。上面54aにおいて血液バッグポケット56よりも径方向内側の中央領域54a1には、第1チューブ34及びセグメントチューブ28の一部分が配置される。また中央領域54a1には、血液バッグポケット56の開口を開閉する蓋体62が設けられている。さらに蓋体62に閉塞される第1チューブ34の配置位置には、封止部材40を破断する破断部64の一部、及び第1チューブ34を流動する血液の状態を検出するセンサ66が設けられている。 In addition, the upper surface 54a of the unit set area 54 is configured to arrange and hold the plurality of tubes 30 of the blood bag system 10. A portion of the first tube 34 and the segment tube 28 are arranged in a central region 54a1 radially inside the blood bag pocket 56 on the upper surface 54a. A lid 62 for opening and closing the opening of the blood bag pocket 56 is provided in the central region 54a1. Further, at the arrangement position of the first tube 34 closed by the lid 62, a part of the breaking portion 64 that breaks the sealing member 40 and a sensor 66 that detects the state of the blood flowing through the first tube 34 are provided. It is
 上面54aの左領域54a2には、中央領域54a1を通った第1チューブ34の一部分、分岐コネクタ32、第2チューブ36及び第3チューブ38の一部分が配置される。この左領域54a2には、分岐コネクタ32を保持するホルダ150、第2チューブ36の第2流路36aを開閉するPPP用クランプ70、及び第3チューブ38の第3流路38aを開閉する薬液用クランプ72が設けられている。 A portion of the first tube 34, a portion of the branch connector 32, a second tube 36 and a portion of the third tube 38 passing through the central region 54a1 are arranged in the left region 54a2 of the upper surface 54a. The left area 54a2 includes a holder 150 for holding the branch connector 32, a PPP clamp 70 for opening and closing the second flow path 36a of the second tube 36, and a chemical solution for opening and closing the third flow path 38a of the third tube 38. A clamp 72 is provided.
 上面54aの右領域54a3には、セグメントチューブ28の複数の密閉チューブ28a(図1参照)を収容するセグメントポケット74が設けられている。 A right region 54a3 of the upper surface 54a is provided with a segment pocket 74 for accommodating a plurality of closed tubes 28a (see FIG. 1) of the segment tube 28. As shown in FIG.
 さらに、単位セットエリア54のPPPバッグポケット58や薬液バッグポケット60よりも径方向外側には、上面54aよりも上方に突出するチューブ保持部76が設けられている。チューブ保持部76は、第2チューブ36を配置させるガイド溝部78を有する。 Furthermore, a tube holding portion 76 that protrudes upward from the upper surface 54a is provided radially outward of the PPP bag pocket 58 and the chemical solution bag pocket 60 of the unit set area 54 . The tube holding portion 76 has a guide groove portion 78 in which the second tube 36 is arranged.
 また、単位セットエリア54は、遠心分離後の血液バッグ22を押圧するスライダ82を血液バッグポケット56の径方向内側に備える。スライダ82は、制御部50(図1参照)の制御下に、遠心ドラム48の径方向に沿って進退する。 The unit set area 54 also includes a slider 82 radially inside the blood bag pocket 56 for pressing the blood bag 22 after centrifugation. The slider 82 advances and retreats along the radial direction of the centrifugal drum 48 under the control of the controller 50 (see FIG. 1).
 上記の単位セットエリア54では、ユーザにより、除去血液を貯留した血液バッグ22が血液バッグポケット56に、空のPPPバッグ24がPPPバッグポケット58に、薬液を貯留した薬液バッグ26が薬液バッグポケット60にそれぞれ収容される。そして、単位セットエリア54は、遠心ドラム48の回転により血液バッグ22の除去血液を遠心分離し、遠心分離後にスライダ82を進出して血液バッグ22を押圧する。これにより、血液バッグ22内で遠心分離により生じたPPPがPPPバッグ24に移送され、PPPの移送後は血液バッグ22にRBCが残留する。PPPの移送後に、血液バッグシステム10は、ユーザにより遠心分離移送装置12から取り出される。 In the unit set area 54 , the user puts the blood bag 22 storing the removed blood into the blood bag pocket 56 , the empty PPP bag 24 into the PPP bag pocket 58 , and the drug solution bag 26 storing the drug solution into the drug solution bag pocket 60 . are accommodated in each. The unit set area 54 centrifuges the removed blood in the blood bag 22 by rotating the centrifugal drum 48 , and advances the slider 82 to press the blood bag 22 after the centrifugal separation. As a result, the PPP produced in the blood bag 22 by centrifugation is transferred to the PPP bag 24, and the RBC remains in the blood bag 22 after the PPP is transferred. After transfer of the PPP, the blood bag system 10 is removed from the centrifuge transfer device 12 by the user.
 次に、本実施形態に係る血液バッグシステム10の圧力開閉弁100について、図3~図6を参照して説明する。 Next, the pressure on-off valve 100 of the blood bag system 10 according to this embodiment will be described with reference to FIGS. 3 to 6. FIG.
 圧力開閉弁100は、上記したように、血液バッグシステム10の第2チューブ36に取り付けられ、第2流路36aを閉塞している。さらに、この圧力開閉弁100は、遠心分離移送装置12によって血液バッグ22が加圧された際の流体圧力によって開通するように構成される。また、圧力開閉弁100は、流体圧力が低下すると、再び閉塞するように構成される。 As described above, the pressure on-off valve 100 is attached to the second tube 36 of the blood bag system 10 and closes the second flow path 36a. Furthermore, the pressure on-off valve 100 is configured to be opened by the fluid pressure when the blood bag 22 is pressurized by the centrifugal transfer device 12 . The pressure on-off valve 100 is also configured to close again when the fluid pressure drops.
 具体的には、図4に示すように、圧力開閉弁100は、樹脂材料又は金属材料によって構成される円筒状の筐体84を備える。そして、圧力開閉弁100の筐体84の一端と他端には、第2チューブ36がそれぞれ接続される第1接続ポート86及び第2接続ポート88が設けられている。筐体84の内部には空洞部84aが形成されている。空洞部84aには、弁体90が配置されている。弁体90は、例えば、ゴムやエラストマー等よりなる軟質な弾性材料よりなる。 Specifically, as shown in FIG. 4, the pressure on-off valve 100 includes a cylindrical housing 84 made of resin material or metal material. A first connection port 86 and a second connection port 88 to which the second tube 36 is connected are provided at one end and the other end of the housing 84 of the pressure on-off valve 100 . A hollow portion 84 a is formed inside the housing 84 . A valve body 90 is arranged in the hollow portion 84a. The valve body 90 is made of a soft elastic material such as rubber or elastomer.
 図5に示すように、弁体90は、円板状の弁本体92と、弁本体92の周縁部から弁本体92の厚さ方向の一方側に(軸方向)に突出した支持部94とを有している。支持部94は、弁本体92の周縁部に沿って円状の壁状に突出して形成されている。図4に示すように、支持部94は、筐体84の内壁に密着しており、圧力が作用した場合であっても弁体90の位置ずれを阻止する。 As shown in FIG. 5, the valve body 90 includes a disk-shaped valve body 92 and a support portion 94 projecting from the peripheral edge portion of the valve body 92 to one side (axial direction) in the thickness direction of the valve body 92 . have. The support portion 94 is formed to protrude in the shape of a circular wall along the peripheral portion of the valve body 92 . As shown in FIG. 4, the support portion 94 is in close contact with the inner wall of the housing 84 and prevents the valve body 90 from being displaced even when pressure is applied.
 弁本体92は、空洞部84aの断面と同一形状に形成されており、空洞部84aを第1接続ポート86の領域と、第2接続ポート88側との領域とに気密及び液密に仕切る。図5に示すように、弁本体92の中央部には、弁本体92の厚さ方向に貫通した線状の切れ込みよりなるスリット96が形成されている。スリット96は、正面視すると円板状の弁本体92の中心軸を通る線状に形成されている。 The valve body 92 is formed in the same shape as the cross section of the hollow portion 84a, and divides the hollow portion 84a into an area on the first connection port 86 side and an area on the second connection port 88 side in an air-tight and liquid-tight manner. As shown in FIG. 5 , a slit 96 is formed in the central portion of the valve body 92 and is a linear cut extending through the valve body 92 in the thickness direction. The slit 96 is formed in a linear shape passing through the central axis of the disk-shaped valve body 92 when viewed from the front.
 スリット96は、圧力が作用しない状態において、密着して閉塞しており、流体の通過を阻止する。弁本体92は、圧力が作用すると弾性変形し、スリット96に隙間が生じて流体の通過を許容する開通状態に変形可能とする。弁体90が開通する際の圧力(開通圧力)は、弁本体92の厚さに応じて適宜設定することができる。弁本体92の厚みが増すと、開通圧力が増大し、弁本体92の厚みが減少すると開通圧力が低下する。 The slit 96 is tightly closed when no pressure is applied, and prevents the passage of fluid. The valve main body 92 is elastically deformed when pressure is applied, and a gap is generated in the slit 96 so that the valve body 92 can be deformed into an open state in which fluid is allowed to pass. The pressure (opening pressure) when the valve body 90 is opened can be appropriately set according to the thickness of the valve body 92 . As the thickness of the valve body 92 increases, the opening pressure increases, and as the thickness of the valve body 92 decreases, the opening pressure decreases.
 弁体90の開通圧力は、少なくとも、薬液バッグ26の添加溶液を自然流下で血液バッグ22に移送する際の圧力によって開放しない程度の値に設定されることが好ましい。本願発明者らが調査した結果、薬液バッグ26の自然流下の際に発生する圧力は、薬液バッグ26と弁体90との落差に応じて変化するが、概ね1.7kPa程度である。また、薬液バッグ26を取り扱う際に軽く握った際に生じる圧力は3.3kPa程度であり、薬液バッグ26を強く握った際に生じる圧力は8kPa程度であった。 The opening pressure of the valve body 90 is preferably set to at least a value that does not open due to the pressure when the added solution in the drug solution bag 26 is transferred to the blood bag 22 under gravity flow. As a result of investigations by the inventors of the present application, the pressure generated when the chemical solution bag 26 naturally flows down varies depending on the difference in height between the chemical solution bag 26 and the valve body 90, but is approximately 1.7 kPa. The pressure generated when the drug solution bag 26 was lightly gripped was about 3.3 kPa, and the pressure generated when the drug solution bag 26 was gripped strongly was about 8 kPa.
 したがって、取り扱いの際に意図しない開通を防ぐ観点からは、開通圧力は1.7kPaよりも高い方が良く、弁体90の開通圧力は少なくとも軽く握るまでは開通しない圧力(例えば、3.3kPa以上)であることが好ましい。但し、弁体90の開通圧力が高すぎると、遠心分離移送装置12の血液バッグ22の加圧によって弁体90が開かなくなってしまうため、開通圧力の上限は、遠心分離移送装置12の発生圧力の上限(例えば、200kPa)以下であることが好ましい。また、PPPバッグ24は、血漿成分の移送後に、ユーザによって気泡を除去する操作が行われる。弁体90の開通圧力が高すぎると、ユーザが気泡を除去する操作が行い難くなることから、より好ましくは、開通圧力の上限はPPPバッグ24を強く握って発生できる圧力(例えば、8kPa)以下であることが好ましい。より好ましくは3.3kPa~6kPaとすると血漿成分と添加溶液との混合防止及びエア抜き操作の観点から好適である。 Therefore, from the viewpoint of preventing unintended opening during handling, the opening pressure should be higher than 1.7 kPa. ) is preferred. However, if the opening pressure of the valve body 90 is too high, the pressure of the blood bag 22 of the centrifugal separation transfer device 12 prevents the valve body 90 from opening. is preferably not more than the upper limit of (for example, 200 kPa). Further, the PPP bag 24 is operated by the user to remove air bubbles after the plasma component is transferred. If the opening pressure of the valve body 90 is too high, it becomes difficult for the user to remove air bubbles. Therefore, the upper limit of the opening pressure is more preferably equal to or less than the pressure (eg, 8 kPa) that can be generated by gripping the PPP bag 24 strongly. is preferably A pressure of 3.3 kPa to 6 kPa is more preferable from the viewpoint of preventing mixing of the plasma component and the additive solution and removing air.
 なお、スリット96は1本に限定されるものではなく、図6の変形例に示すように、複数のスリット96を中心軸回りに放射状に設けてもよい。以上の圧力開閉弁100は、図3に示すように、第2チューブ36の途上に接続される。特に限定されるものではないが、圧力開閉弁100は、分岐コネクタ32の近傍の第2チューブ36に接続することができる。 The number of slits 96 is not limited to one, and a plurality of slits 96 may be provided radially around the central axis as shown in the modified example of FIG. The above pressure on-off valve 100 is connected to the middle of the second tube 36 as shown in FIG. Although not particularly limited, the pressure on-off valve 100 can be connected to the second tube 36 near the branch connector 32 .
 図3に示すように、ホルダ150は、分岐コネクタ32を保持するコネクタ保持部152と、クランプ37を保持するクランプ保持部154とを有する。圧力開閉弁100は、遠心分離移送装置12に対する血液バッグシステム10のセット時に、分岐コネクタ32と共にホルダ150の近傍に配置される。 As shown in FIG. 3 , the holder 150 has a connector holding portion 152 holding the branch connector 32 and a clamp holding portion 154 holding the clamp 37 . The pressure on-off valve 100 is arranged near the holder 150 together with the branch connector 32 when the blood bag system 10 is set on the centrifugal transfer device 12 .
 コネクタ保持部152は、円柱状に形成され、上端部から所定深さ切り欠いたY字状の保持用溝152aを有し、分岐コネクタ32を外から嵌合可能に構成されている。 The connector holding portion 152 is formed in a columnar shape, has a Y-shaped holding groove 152a cut from the upper end portion to a predetermined depth, and is configured so that the branch connector 32 can be fitted from the outside.
 以上の圧力開閉弁100は、その製造において、バッグ20やチューブ30とは別に、射出成形等により弁本体92を形成する。そして、筐体84に弁本体92を配置し、第1接続ポート86及び第2接続ポート88を接続することで圧力開閉弁100が製造される。血液バッグシステム10を組み立てる際に、第2チューブ36に圧力開閉弁100が接続され、第3チューブ38にクランプ37を取り付ける。その後に第2チューブ36及び第3チューブ38を分岐コネクタ32に固着する。これにより、圧力開閉弁100を有する血液バッグシステム10が形成される。 In manufacturing the above-described pressure on-off valve 100, the valve body 92 is formed by injection molding or the like separately from the bag 20 and the tube 30. By arranging the valve body 92 in the housing 84 and connecting the first connection port 86 and the second connection port 88, the pressure on-off valve 100 is manufactured. When assembling the blood bag system 10 , the pressure on/off valve 100 is connected to the second tube 36 and the clamp 37 is attached to the third tube 38 . The second tube 36 and the third tube 38 are then secured to the branch connector 32 . Thereby, the blood bag system 10 having the pressure on-off valve 100 is formed.
 第1実施形態に係る血液バッグシステム10は、基本的には以上のように構成されるものであり、以下その動作について、血液の処理方法と共に説明する。 The blood bag system 10 according to the first embodiment is basically configured as described above, and the operation thereof will be described below together with the blood processing method.
 血液バッグシステム10を用いた血液の処理方法は、ユーザにより、図7に示すように採血ステップ(ステップS1)、白血球除去ステップ(ステップS2)、装置セットステップ(ステップS3)、遠心分離ステップ(ステップS4)、血漿成分移送ステップ(ステップS5)、装置取り出しステップ(ステップS6)、懸架ステップ(ステップS7)、添加溶液注入ステップ(ステップS8)、シール分離ステップ(ステップS9)からなる作業フローが順に実施される。 The blood processing method using the blood bag system 10 includes a blood collection step (step S1), a leukocyte removal step (step S2), an apparatus setting step (step S3), a centrifugation step (step S4), a plasma component transfer step (step S5), an apparatus extraction step (step S6), a suspension step (step S7), an additive solution injection step (step S8), and a seal separation step (step S9). be done.
 採血ステップ(ステップS1)において、ユーザは、図示しない前処理部の採血針を用いて供血者の全血を採取し採血バッグに貯留する。次に、白血球除去ステップ(ステップS2)において、ユーザは、採血バッグから血液バッグ22に全血を移動させる。この際に、全血がフィルタを通過することで、全血から白血球を除いた除去血液が血液バッグ22に貯留される。 In the blood collection step (step S1), the user collects the donor's whole blood using the blood collection needle of the preprocessing unit (not shown) and stores it in a blood collection bag. Next, in the leukocyte removal step (step S2), the user moves whole blood from the blood collection bag to the blood bag 22. FIG. At this time, the whole blood passes through the filter, and the blood bag 22 stores the removed blood from which leukocytes have been removed from the whole blood.
 ユーザは、除去血液を遠心分離するために、装置セットステップ(ステップS3)において、血液バッグシステム10の分離処理部16を前処理部から切り離して遠心分離移送装置12にセットする。図2に示すように、ユーザは、血液バッグ22を単位セットエリア54の血液バッグポケット56に収容し、また単位セットエリア54の上面54aの所定の経路に沿って第1チューブ34、第2チューブ36、及び第3チューブ38をセットする。第1チューブ34は、中央領域54a1の所定の経路に取り回された後、左領域54a2に向かうように配置される。さらに、ユーザは、左領域54a2において第1チューブ34、第2チューブ36、及び第3チューブ38を取り回すと共に、分岐コネクタ32及びクランプ37をホルダ150に保持する。 In order to centrifuge the removed blood, the user separates the separation processing section 16 of the blood bag system 10 from the preprocessing section and sets it on the centrifugal transfer device 12 in the device setting step (step S3). As shown in FIG. 2, the user stores the blood bag 22 in the blood bag pocket 56 of the unit setting area 54, and along the predetermined path on the upper surface 54a of the unit setting area 54, the first tube 34 and the second tube. 36, and the third tube 38 are set. The first tube 34 is routed along a predetermined path in the central area 54a1 and then directed toward the left area 54a2. Further, the user manages the first tube 34, the second tube 36, and the third tube 38 in the left area 54a2, and holds the branch connector 32 and the clamp 37 in the holder 150.
 第2チューブ36は、分岐コネクタ32から左領域54a2を遠心方向外側に延在し、PPP用クランプ70を通るように配置される。さらに第2チューブ36は、薬液バッグポケット60の径方向外側でチューブ保持部76のガイド溝部78に収容される。第3チューブ38も、分岐コネクタ32から左領域54a2を遠心方向外側に延在し、薬液用クランプ72を通るように配置される。そして、ユーザは、第2チューブ36に繋がるPPPバッグ24をPPPバッグポケット58に収容すると共に、第3チューブ38に繋がる薬液バッグ26を薬液バッグポケット60に収容する。これにより遠心分離移送装置12への血液バッグシステム10のセットが完了する。 The second tube 36 extends outward in the centrifugal direction from the branch connector 32 through the left area 54 a 2 and is arranged to pass through the PPP clamp 70 . Further, the second tube 36 is accommodated in the guide groove portion 78 of the tube holding portion 76 radially outside the medical solution bag pocket 60 . The third tube 38 also extends outward in the centrifugal direction from the branch connector 32 through the left region 54 a 2 and is arranged to pass through the drug solution clamp 72 . Then, the user stores the PPP bag 24 connected to the second tube 36 in the PPP bag pocket 58 and stores the drug solution bag 26 connected to the third tube 38 in the drug solution bag pocket 60 . This completes the setting of the blood bag system 10 to the centrifugal transfer device 12 .
 図3に示すように、ユーザは、ホルダ150のコネクタ保持部152に分岐コネクタ32を装着し、これと同時にホルダ150の保持板160と対向壁161の間の配置空間162に、クランプ37を挿入する。装置セットステップ(ステップS3)の後、圧力開閉弁100は第2チューブ36の第2流路36aを閉塞している。 As shown in FIG. 3, the user attaches the branch connector 32 to the connector holding portion 152 of the holder 150, and at the same time inserts the clamp 37 into the arrangement space 162 between the holding plate 160 and the opposing wall 161 of the holder 150. do. After the device setting step (step S3), the pressure on-off valve 100 closes the second flow path 36a of the second tube 36. As shown in FIG.
 その後、遠心分離ステップ(ステップS4)において、遠心分離移送装置12は、制御部50の制御下に遠心ドラム48を回転させることで、血液バッグ22の除去血液を、比重が異なるPPP、RBC等の血液成分に遠心分離する。遠心分離時に、第2チューブ36及び第3チューブ38は、PPP用クランプ70及び薬液用クランプ72(共に図2参照)により閉塞されており、血液成分の流動が抑制される。 Thereafter, in the centrifugal separation step (step S4), the centrifugal transfer device 12 rotates the centrifugal drum 48 under the control of the control unit 50, thereby separating the removed blood from the blood bag 22 into PPP, RBC, etc. having different specific gravities. Centrifuge into blood components. During centrifugation, the second tube 36 and the third tube 38 are closed by the PPP clamp 70 and the drug solution clamp 72 (see FIG. 2 for both), thereby suppressing the flow of blood components.
 また血漿成分移送ステップ(ステップS5)において、遠心分離移送装置12は、PPP用クランプ70のみを開放して、スライダ82により血液バッグ22を押圧する。これにより、図8Aに示すように、第2チューブ36に設けられた圧力開閉弁100が開通する。そして、血液バッグ22のPPPが、第1チューブ34、分岐コネクタ32、第2チューブ36を順に流動してPPPバッグ24に流入する。 In addition, in the plasma component transfer step (step S5), the centrifugal transfer device 12 releases only the PPP clamp 70 and presses the blood bag 22 with the slider 82 . As a result, as shown in FIG. 8A, the pressure on-off valve 100 provided on the second tube 36 is opened. The PPP in the blood bag 22 then flows through the first tube 34 , the branch connector 32 and the second tube 36 in order and flows into the PPP bag 24 .
 血漿成分移送ステップ(ステップS5)の後、第2流路36aの圧力低下に伴って、圧力開閉弁100が閉塞する。したがって、第2流路36a及び第3流路38aが閉塞した状態に復帰する。 After the plasma component transfer step (step S5), the pressure on-off valve 100 is closed as the pressure in the second channel 36a decreases. Therefore, the second flow path 36a and the third flow path 38a return to the blocked state.
 次に図7の装置取り出しステップ(ステップS6)において、遠心分離移送装置12は、スライダ82を後退させ、また薬液用クランプ72(図2参照)を開放することで、血液バッグシステム10を遠心分離移送装置12から離脱可能とする。ユーザは、クランプ37で第3チューブ38の第3流路38aを閉塞する。その後、ユーザが血液バッグシステム10を取り出す。そしてユーザは、懸架ステップ(ステップS7)において、薬液バッグ26を図示しないスタンドに吊り下げ、さらに薬液バッグ26よりも重力方向下側に血液バッグ22を配置する。 7, the centrifugal transfer device 12 retracts the slider 82 and opens the drug solution clamp 72 (see FIG. 2) to centrifuge the blood bag system 10. It is made separable from the transfer device 12 . The user closes the third channel 38 a of the third tube 38 with the clamp 37 . After that, the user takes out the blood bag system 10 . Then, in the suspending step (step S7), the user suspends the drug solution bag 26 on a stand (not shown) and further arranges the blood bag 22 below the drug solution bag 26 in the direction of gravity.
 次に、添加溶液注入ステップ(ステップS8)において、ユーザは、第3チューブ38を開放させると共に、封止部材42を破断することで、図8Bに示すように、薬液バッグ26の添加溶液を血液バッグ22に供給する。この際、ユーザは、クランプ37を変形させることで第3流路38aを開通させる。これにより、薬液バッグ26の添加溶液は、第3チューブ38及び第1チューブ34を通じて血液バッグ22に注入される。第2チューブ36の圧力開閉弁100には、薬液バッグ26との落差に応じた圧力が作用するが、圧力開閉弁100の開通圧力よりも低いため、圧力開閉弁100は閉塞した状態に保たれる。したがって、本実施形態によれば、第2チューブ36にクランプ37を設けなくても、添加溶液のPPPバッグ24への混入を防止できる。 Next, in the additive solution injection step (step S8), the user opens the third tube 38 and breaks the sealing member 42, so that the additive solution in the drug solution bag 26 is poured into the blood as shown in FIG. 8B. Supply bag 22 . At this time, the user opens the third channel 38 a by deforming the clamp 37 . As a result, the added solution in the drug solution bag 26 is injected into the blood bag 22 through the third tube 38 and the first tube 34 . The pressure on/off valve 100 of the second tube 36 receives a pressure corresponding to the difference in height from the liquid medicine bag 26, but since it is lower than the opening pressure of the pressure on/off valve 100, the pressure on/off valve 100 is kept closed. be Therefore, according to this embodiment, it is possible to prevent the additive solution from entering the PPP bag 24 without providing the clamp 37 on the second tube 36 .
 添加溶液注入ステップ(ステップS8)後のシール分離ステップ(ステップS9)において、ユーザは、第1チューブ34の適宜の位置をシール及び切断する。これにより、血液バッグ22は、添加溶液を含むRBCが貯留された状態で血液バッグシステム10から分離する。同様に、ユーザは、第2チューブ36において圧力開閉弁100よりもPPPバッグ24側をシール及び切断する。これによりPPPバッグ24は、PPPが貯留された状態で血液バッグシステム10から分離する。残された血液バッグシステム10は、圧力開閉弁100を含めて適宜廃棄される。 In the seal separation step (step S9) after the additive solution injection step (step S8), the user seals and cuts the first tube 34 at an appropriate position. As a result, the blood bag 22 is separated from the blood bag system 10 with the RBCs containing the added solution stored therein. Similarly, the user seals and cuts the PPP bag 24 side of the pressure shut-off valve 100 in the second tube 36 . This separates the PPP bag 24 from the blood bag system 10 with the PPP stored therein. The remaining blood bag system 10 including the pressure on-off valve 100 is discarded as appropriate.
 なお、本発明は、上記の実施形態に限定されず、発明の要旨に沿って種々の改変が可能である。例えば、図9に示すように、血液バッグシステム10の圧力開閉弁100のように、弁本体92を第2チューブ36Aの第2流路36aに配置して、圧力開閉弁100を第2チューブ36Aと一体化してもよい。 It should be noted that the present invention is not limited to the above embodiments, and various modifications are possible in line with the gist of the invention. For example, as shown in FIG. 9, like the pressure on-off valve 100 of the blood bag system 10, the valve body 92 is arranged in the second flow path 36a of the second tube 36A, and the pressure on-off valve 100 is connected to the second tube 36A. may be integrated with
 また、例えば、図10に示す圧力開閉弁100のように、弁本体92を分岐コネクタ32Aの内部に配置して、圧力開閉弁100を分岐コネクタ32Aと一体化してもよい。 Further, for example, like the pressure on-off valve 100 shown in FIG. 10, the valve body 92 may be arranged inside the branch connector 32A, and the pressure on-off valve 100 may be integrated with the branch connector 32A.
 本実施形態の血液バッグシステム10は、以下の効果を奏する。 The blood bag system 10 of this embodiment has the following effects.
 本実施形態の血液バッグシステム10は、血液を収容するための第1バッグ(例えば、血液バッグ22)と、第1バッグ内の血液を遠心分離して得られた血液成分を収容するための第2バッグ(例えば、PPPバッグ24)と、添加溶液が収容された第3バッグ(例えば、薬液バッグ26)と、第1バッグに接続される第1チューブ34と、第2バッグに接続される第2チューブ36と、第3バッグに接続される第3チューブ38と、第1チューブ34、第2チューブ36及び第3チューブ38を連結する分岐部(例えば、分岐コネクタ32)と、第2チューブ36を通る流路(例えば、第2流路36a)上又は分岐部の内部の第2チューブ36に向かう流路上に設けられ、流路を閉塞すると共に、流路内の圧力が所定の開通圧力以上となると流路を開通させる圧力開閉弁100と、を備える。 The blood bag system 10 of this embodiment includes a first bag (for example, a blood bag 22) for containing blood, and a first bag for containing blood components obtained by centrifuging the blood in the first bag. 2 bags (for example, PPP bag 24), a third bag (for example, drug solution bag 26) containing an additive solution, a first tube 34 connected to the first bag, and a second bag connected to the second bag a second tube 36, a third tube 38 connected to a third bag, a branch portion (for example, a branch connector 32) connecting the first tube 34, the second tube 36 and the third tube 38, and the second tube 36 provided on the flow path (for example, the second flow path 36a) passing through or on the flow path toward the second tube 36 inside the branch, closing the flow path and increasing the pressure in the flow path to a predetermined opening pressure or higher Then, it is provided with a pressure on-off valve 100 that opens the flow path.
 上記の構成によれば、手動式のクランプ37は、第2チューブ36及び第3チューブ38のいずれか一方のみで済むため、2つのクランプの開閉操作が不要となり、ユーザの操作性が向上する。また、ユーザは1つのクランプ37の開閉操作に集中できるため、クランプ37の誤操作を起こしにくくなる。 According to the above configuration, only one of the second tube 36 and the third tube 38 is required for the manual clamp 37, which eliminates the need to open and close the two clamps, improving user operability. In addition, since the user can concentrate on opening and closing one clamp 37, it is less likely that the clamp 37 will be erroneously operated.
 上記の血液バッグシステム10において、圧力開閉弁100は、第3チューブ38を通る流路上又は分岐部の第3チューブ38に向かう流路上に設けてもよい。 In the blood bag system 10 described above, the pressure on-off valve 100 may be provided on the flow path passing through the third tube 38 or on the flow path toward the third tube 38 at the branch.
 上記の血液バッグシステム10において、圧力開閉弁100は、第2チューブ36に設けられると共に、圧力開閉弁100の開通圧力は、第3バッグと圧力開閉弁100との落差によって作用する添加溶液の圧力よりも高くしてもよい。この構成によれば、血液バッグシステム10において、遠心分離ステップの後に行われる、第3バッグから第1バッグに向けた添加溶液の注入操作において、圧力開閉弁100が閉塞した状態に保たれるため、第2チューブ36側への添加溶液の流入を防止できる。すなわち、第2チューブ36へのクランプ37の装着が不要となる。これにより、ユーザの作業性が向上する。 In the blood bag system 10 described above, the pressure on-off valve 100 is provided in the second tube 36, and the opening pressure of the pressure on-off valve 100 is the pressure of the additive solution that acts due to the drop between the third bag and the pressure on-off valve 100. can be higher than According to this configuration, in the blood bag system 10, the pressure opening/closing valve 100 is kept closed during the operation of injecting the additive solution from the third bag to the first bag, which is performed after the centrifugation step. , the addition solution can be prevented from flowing into the second tube 36 side. That is, it becomes unnecessary to attach the clamp 37 to the second tube 36 . This improves workability for the user.
 上記の血液バッグシステム10において、圧力開閉弁100の開通圧力は、3.3kPa以上であってもよい。このように構成することにより、添加溶液の第2バッグへの混入を効果的に防止できる。 In the blood bag system 10 described above, the opening pressure of the pressure on-off valve 100 may be 3.3 kPa or more. By configuring in this way, it is possible to effectively prevent the additive solution from being mixed into the second bag.
 上記の血液バッグシステム10において、圧力開閉弁100の開通圧力は200kPa以下であってもよい。このように構成することにより、第1バッグから第2バッグへの血液成分の移送の際に圧力開閉弁100が確実に開放するため、血液成分の移送を確実に行える。 In the blood bag system 10 described above, the opening pressure of the pressure on-off valve 100 may be 200 kPa or less. With this configuration, the pressure opening/closing valve 100 is reliably opened when the blood components are transferred from the first bag to the second bag, so that the blood components can be reliably transferred.
 上記の血液バッグシステム10において、圧力開閉弁100は、分岐部の内部に設けられてもよい。この構成によれば、装置構成が簡素化され、取り扱い性が向上する。 In the blood bag system 10 described above, the pressure on-off valve 100 may be provided inside the branch. This configuration simplifies the configuration of the device and improves the handleability.
 上記の血液バッグシステム10において、圧力開閉弁100は第2チューブ36又は第3チューブ38の内部に設けられてもよい。この構成によれば、装置構成が簡素化され、取り扱い性が向上する。 In the blood bag system 10 described above, the pressure on-off valve 100 may be provided inside the second tube 36 or the third tube 38 . This configuration simplifies the configuration of the device and improves the handleability.
 上記の血液バッグシステム10において、圧力開閉弁100は、流路を閉塞する板状(例えば、円板状)の弁本体92と、流路の壁面に当接する支持部94と、弁本体92の中心軸を通り、且つ弁本体92を厚さ方向に貫通するスリット96と、を有してもよい。 In the blood bag system 10 described above, the pressure on-off valve 100 includes a plate-like (for example, disk-like) valve body 92 that closes the flow path, a support portion 94 that contacts the wall surface of the flow path, and a valve body 92. and a slit 96 passing through the central axis and through the valve body 92 in the thickness direction.
 上記の血液バッグシステム10において、スリット96は放射状に複数本設けられてもよい。 In the blood bag system 10 described above, a plurality of slits 96 may be radially provided.
 上記の血液バッグシステム10において、弁本体92の流路の軸線方向の厚さは、支持部94の流路の軸線方向の厚さよりも薄くてもよい。この構成によれば、弁本体92が圧力に応じて変形して開閉することができる。 In the blood bag system 10 described above, the axial thickness of the channel of the valve body 92 may be thinner than the axial thickness of the channel of the support portion 94 . According to this configuration, the valve body 92 can be deformed and opened and closed according to the pressure.
 上記の血液バッグシステム10において、圧力開閉弁100はゴム又はエラストマーであってもよい。 In the blood bag system 10 described above, the pressure on-off valve 100 may be made of rubber or elastomer.
 本実施形態の血液の処理方法は、上記の血液バッグシステム10を用いた血液の処理方法であって、遠心力の作用下で第1バッグの血液を血液成分に分離するステップと、第1バッグを加圧することにより、圧力開閉弁100を開通させて血液成分の一部を第2バッグに移送するステップと、第3バッグの添加溶液を自然流下により第1バッグに移送するステップと、を有する。 The blood processing method of the present embodiment is a method of processing blood using the above-described blood bag system 10, comprising the step of separating the blood in the first bag into blood components under the action of centrifugal force; by pressurizing to open the pressure on-off valve 100 to transfer a portion of the blood components to the second bag; and transferring the additive solution in the third bag to the first bag by gravity flow. .
 上記の血液の処理方法によれば、使用者は1つのクランプ37の開閉操作に集中することができるので、誤開閉を防止できる。 According to the blood processing method described above, the user can concentrate on opening and closing one clamp 37, thereby preventing erroneous opening and closing.
 上記の血液の処理方法において、前記遠心力の作用下で前記第1バッグの血液を血液成分に分離するステップの後に、前記第3チューブをクランプで閉塞するステップと、前記第1バッグの加圧を解除した後に、前記第3チューブから前記クランプを取り外すステップと、をさらに有してもよい。 In the above blood processing method, after the step of separating the blood in the first bag into blood components under the action of the centrifugal force, closing the third tube with a clamp; and pressurizing the first bag. removing the clamp from the third tube after releasing the .
 上記において、本発明について好適な実施形態を挙げて説明したが、本発明は上記実施形態に限定されるものではなく、本発明の趣旨を逸脱しない範囲において、種々の改変が可能なことは言うまでもない。 Although the preferred embodiments of the present invention have been described above, the present invention is not limited to the above embodiments, and it goes without saying that various modifications can be made without departing from the scope of the present invention. stomach.

Claims (12)

  1.  血液を収容するための第1バッグと、
     前記第1バッグ内の血液を遠心分離して得られた血液成分を収容するための第2バッグと、
     添加溶液が収容された第3バッグと、
     前記第1バッグに接続される第1チューブと、
     前記第2バッグに接続される第2チューブと、
     前記第3バッグに接続される第3チューブと、
     前記第1チューブ、前記第2チューブ及び前記第3チューブを連結する分岐部と、
     前記第2チューブを通る流路上又は前記分岐部の内部の前記第2チューブに向かう流路上に設けられ、前記流路を閉塞すると共に、前記流路内の圧力が所定の開通圧力以上となると前記流路を開通させる圧力開閉弁と、
     を備える血液バッグシステム。
    a first bag for containing blood;
    a second bag for containing blood components obtained by centrifuging the blood in the first bag;
    a third bag containing an additive solution;
    a first tube connected to the first bag;
    a second tube connected to the second bag;
    a third tube connected to the third bag;
    a branching portion that connects the first tube, the second tube, and the third tube;
    It is provided on the flow path passing through the second tube or on the flow path toward the second tube inside the branch portion, and closes the flow path, and when the pressure in the flow path reaches a predetermined opening pressure or higher, the a pressure on-off valve that opens the flow path;
    A blood bag system comprising:
  2.  請求項1記載の血液バッグシステムであって、前記圧力開閉弁は第3チューブを通る流路上又は前記分岐部の内の前記第3チューブに向かう流路上に設けられている、血液バッグシステム。 The blood bag system according to claim 1, wherein the pressure on-off valve is provided on a flow path passing through the third tube or on a flow path within the branch section toward the third tube.
  3.  請求項1又は2記載の血液バッグシステムであって、前記圧力開閉弁の前記開通圧力は、前記第3バッグと前記圧力開閉弁との落差によって作用する前記添加溶液の圧力よりも高い、血液バッグシステム。 3. The blood bag system according to claim 1 or 2, wherein said opening pressure of said pressure on-off valve is higher than the pressure of said additive solution acting due to the head difference between said third bag and said pressure on-off valve. system.
  4.  請求項1~3のいずれか1項に記載の血液バッグシステムであって、前記圧力開閉弁の前記開通圧力は、3.3kPa以上である、血液バッグシステム。 The blood bag system according to any one of claims 1 to 3, wherein the opening pressure of the pressure on-off valve is 3.3 kPa or more.
  5.  請求項1~4のいずれか1項に記載の血液バッグシステムであって、前記圧力開閉弁の前記開通圧力は200kPa以下である、血液バッグシステム。 The blood bag system according to any one of claims 1 to 4, wherein the opening pressure of the pressure on-off valve is 200 kPa or less.
  6.  請求項1~5のいずれか1項に記載の血液バッグシステムであって、前記圧力開閉弁は、前記分岐部の内部に設けられている、血液バッグシステム。 The blood bag system according to any one of claims 1 to 5, wherein said pressure on-off valve is provided inside said branch.
  7.  請求項1~6のいずれか1項に記載の血液バッグシステムであって、前記圧力開閉弁は、
     前記流路を閉塞する板状の弁本体と、
     前記流路の壁面に当接する支持部と、
     前記弁本体の中心軸を通り、且つ前記弁本体を厚さ方向に貫通するスリットと、
     を有する、血液バッグシステム。
    The blood bag system according to any one of claims 1 to 6, wherein the pressure on-off valve is
    a plate-like valve body that closes the flow path;
    a support portion that abuts against the wall surface of the channel;
    a slit passing through the central axis of the valve body and penetrating the valve body in the thickness direction;
    A blood bag system comprising:
  8.  請求項7記載の血液バッグシステムであって、前記スリットは放射状に複数本設けられている、血液バッグシステム。 The blood bag system according to claim 7, wherein a plurality of said slits are radially provided.
  9.  請求項7又は8記載の血液バッグシステムであって、前記弁本体の前記流路の軸線方向の厚さは、前記支持部の前記軸線方向の厚さよりも薄い、血液バッグシステム。 The blood bag system according to claim 7 or 8, wherein the axial thickness of the flow path of the valve body is thinner than the axial thickness of the support portion.
  10.  請求項7~9のいずれか1項に記載の血液バッグシステムであって、前記圧力開閉弁はゴム又はエラストマーよりなる、血液バッグシステム。 The blood bag system according to any one of claims 7 to 9, wherein said pressure on-off valve is made of rubber or elastomer.
  11.  請求項1記載の血液バッグシステムを用いた血液の処理方法であって、
     遠心力の作用下で前記第1バッグの血液を血液成分に分離するステップと、
     前記第1バッグを加圧することにより、前記圧力開閉弁を開放させて血液成分の一部を前記第2バッグに移送するステップと、
     前記第3バッグの添加溶液を自然流下により前記第1バッグに移送するステップと、
     を有する、血液の処理方法。
    A blood processing method using the blood bag system according to claim 1,
    separating the blood in the first bag into blood components under the action of centrifugal force;
    pressurizing the first bag to open the pressure on-off valve and transfer a portion of the blood components to the second bag;
    transferring the additive solution in the third bag to the first bag by gravity flow;
    A method of treating blood, comprising:
  12.  請求項11記載の血液の処理方法であって、
     前記遠心力の作用下で前記第1バッグの血液を血液成分に分離するステップの後に、
     前記第3チューブをクランプで閉塞するステップと、
     前記第1バッグの加圧を解除した後に、前記第3チューブから前記クランプを取り外すステップと、
     をさらに有する、血液の処理方法。
    The method for treating blood according to claim 11,
    After separating the blood in the first bag into blood components under the action of the centrifugal force,
    clamping the third tube;
    removing the clamp from the third tube after depressurizing the first bag;
    A method of treating blood, further comprising:
PCT/JP2022/008229 2021-03-01 2022-02-28 Blood bag system and blood treatment method WO2022186122A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
JP2023503811A JPWO2022186122A1 (en) 2021-03-01 2022-02-28

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2021031557 2021-03-01
JP2021-031557 2021-03-01

Publications (1)

Publication Number Publication Date
WO2022186122A1 true WO2022186122A1 (en) 2022-09-09

Family

ID=83154421

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/JP2022/008229 WO2022186122A1 (en) 2021-03-01 2022-02-28 Blood bag system and blood treatment method

Country Status (2)

Country Link
JP (1) JPWO2022186122A1 (en)
WO (1) WO2022186122A1 (en)

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001245968A (en) * 2000-03-07 2001-09-11 Terumo Corp Method and device for separating blood component
JP2004105581A (en) * 2002-09-20 2004-04-08 Haemonetics Corp Apheresis system, and method therefor

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001245968A (en) * 2000-03-07 2001-09-11 Terumo Corp Method and device for separating blood component
JP2004105581A (en) * 2002-09-20 2004-04-08 Haemonetics Corp Apheresis system, and method therefor

Also Published As

Publication number Publication date
JPWO2022186122A1 (en) 2022-09-09

Similar Documents

Publication Publication Date Title
US9839730B2 (en) Blood bag system and cassette
JP4800617B2 (en) Method and apparatus for blood component separation
EP2349395B1 (en) Blood bag system and cassette
EP2696912B1 (en) Centrifugation system with red blood cell barrier
US11712497B2 (en) Blood bag system and blood treatment method
WO2022186122A1 (en) Blood bag system and blood treatment method
EP2823831B1 (en) Systems and methods for extracting platelet-rich plasma for therapeutic injection
WO2020184019A1 (en) Blood bag system
US20220016323A1 (en) Blood bag system and clamp
JP6805384B1 (en) Blood bag system, centrifuge system and clamp
WO2020184018A1 (en) Blood bag system
KR101433821B1 (en) Platelet concentrate set of automatically inserting anticoagulant
JP6840894B1 (en) Blood bag system and clamp
JP7140755B2 (en) Platelet separator, platelet collection device, platelet collection system and platelet collection method
JP6805393B1 (en) Blood bag system
JP6297357B2 (en) Blood bag system
JP2020146282A (en) Blood bag system and method for using the same

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22763178

Country of ref document: EP

Kind code of ref document: A1

ENP Entry into the national phase

Ref document number: 2023503811

Country of ref document: JP

Kind code of ref document: A

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 22763178

Country of ref document: EP

Kind code of ref document: A1