Blood bag system and blood processing method

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

[Technical Field]

[0001] The present invention relates to a blood bag system used for separating blood components and a method for treating blood. [Background technology]

[0002] Japanese Patent Application Laid-Open Publication No. 2016-106012 discloses a blood bag system including a first bag (parent bag) for storing blood, a second bag (child bag) for storing blood components obtained by centrifuging the blood in the first bag, and a third bag (medicinal solution bag) for storing 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, and the first to third tubes are connected to each other by a branching section (Y-shaped connector).

[0003] When the blood bag system is set in a centrifugal separator by a user such as a medical professional, it constitutes a centrifuge system that centrifuges blood to produce blood components and transfers a liquid containing the blood components between the first to third bags. 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 a first clamp and closes the flow path of the third tube with a second clamp. In this state, the user removes the blood bag system from the centrifugal separator and suspends it on a suspension stand, and then removes the second clamp from the third tube to transfer the additive solution from the third bag to the first bag. Summary of the Invention

[0004] Conventional blood bag systems require the user to operate two clamps, which makes clamp operation cumbersome and increases the risk of incorrect operation, such as releasing the wrong clamp.

[0005] The present invention has been made in consideration of the above problems, and aims to provide a blood bag system and a blood processing method that can facilitate clamp operation and prevent incorrect clamp operation.

[0006] One aspect of the following disclosure is a blood bag system comprising: a first bag for storing blood; a second bag for storing blood components obtained by centrifuging the blood in the first bag; a third bag for storing 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 section connecting the first tube, the second tube, and the third tube; and a pressure on-off valve provided on a flow path passing through the second tube or on a flow path toward the second tube inside the branching section, which closes the flow path and opens the flow path when the pressure in the flow path reaches or exceeds a predetermined opening pressure.

[0007] Another aspect is a method for treating blood using the blood bag system of the above aspect, comprising the steps of: 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 some of the blood components to the second bag; and transferring the additive solution in the third bag to the first bag by gravity flow.

[0008] According to the blood bag system and blood processing method described above, by using a pressure opening / closing valve instead of one of the two conventional clamps, the number of clamps can be reduced to just one, making operation easier and preventing users from operating the clamp incorrectly. [Brief explanation of the drawings]

[0009] [Figure 1] 1 is an explanatory diagram showing the overall configuration of a blood bag system and a centrifugal separation system according to a first embodiment.

[0023] FIG. [Figure 2] FIG. 10 is a plan view showing a unit set area of ​​the centrifugal component transfer device. [Figure 3]FIG. 10 is a perspective view showing a state in which a branching portion of the blood bag system is set in a holder of a centrifugal separation and transfer device. [Figure 4] FIG. 2 is a cross-sectional view of a pressure on-off valve. [Figure 5] FIG. 5 is a cutaway perspective view of the valve body of the pressure on-off valve of FIG. [Figure 6] 5 is a plan view showing a modified example of the slit of the pressure on-off valve of FIG. 4. FIG. [Figure 7] 2 is a flowchart showing a method for treating blood using the blood bag system of FIG. 1. [Figure 8] 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 when the additive solution is transferred under gravity flow. [Figure 9] FIG. 10 is a cross-sectional view showing a modified example (part 1) of the application portion of the pressure on-off valve. [Figure 10] FIG. 10 is a cross-sectional view showing a modified example (part 2) of the application portion of the pressure on-off valve. DETAILED DESCRIPTION OF THE INVENTION

[0010] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will now be described in detail with reference to preferred embodiments thereof and the accompanying drawings.

[0011] (First embodiment) A blood bag system 10 according to the first embodiment of the present invention is set in a centrifugal separation and transfer device 12 by a user such as a medical professional, as shown in Figure 1. The centrifugal separation and transfer device 12 centrifuges the blood in the blood bag system 10 to generate multiple types of blood components, and transfers the generated blood components to appropriate bags 20 for storage. Hereinafter, a configuration including the blood bag system 10 and the centrifugal separation and transfer device 12 will be referred to as a centrifugal separation system 14.

[0012] The blood bag system 10 has a pre-treatment section (not shown) used to collect blood before centrifugation, a separation treatment section 16 that generates blood components by centrifugation and stores them separately, and a relay tube 18 that connects the pre-treatment section and the separation treatment section 16. Before centrifugation, the relay tube 18 connecting to the pre-treatment section is cut off, and the separation treatment section 16 is set in the centrifugal separation and transfer device 12 in the state shown in Figure 1.

[0013] The pretreatment section of the blood bag system 10 collects whole blood from a donor and removes blood components such as white blood cells from the whole blood. To this end, the pretreatment section includes a blood collection needle, a blood collection bag, an initial blood flow bag, a filter (e.g., a white blood cell removal filter), and other components (not shown), and is configured by connecting these components via multiple tubes 30. Specifically, the pretreatment section stores the initial blood from 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. Furthermore, the pretreatment section removes white blood cells in the filter by passing the whole blood stored in the blood collection bag through the filter. The blood after white blood cell removal is then transferred via a relay tube 18 to a separation processing section 16 connected to the filter.

[0014] The separation processing unit 16 of the blood bag system 10 has a plurality of bags 20 (blood bags 22, PPP bags 24, and drug solution bags 26), and is configured by connecting each bag 20 with a plurality of tubes 30.

[0015] In the delivered state of the blood bag system 10, the blood bag 22 is directly connected to the relay tube 18 that connects to the pre-treatment unit. The blood bag 22 is a first bag having a first storage space 22a that stores blood from which white blood cells have been removed by passing it through a filter during blood collection. The blood bag 22 is set in the centrifugal separation device 12, and centrifugal force is applied by the operation of the centrifugal separation device 12. As a result, the removed blood in the blood bag 22 is centrifuged to separate blood components such as platelet poor plasma (PPP) and red blood cells (RBC), which have different specific gravities. After centrifugation, the PPP is transferred under the operation of the centrifugal separation device 12, and the blood bag 22 stores only the remaining RBCs.

[0016] The PPP bag 24 is a second bag (plasma bag) that stores the PPP in the second storage space 24a when the PPP is supplied from the blood bag 22. On the other hand, the drug solution bag 26 is a third bag that stores a red blood cell preservation solution (hereinafter referred to as an additive solution) such as MAP solution, SAGM solution, or OPTISOL in the third storage space 26a in advance.

[0017] Before the separation processing section 16 is set in the centrifugal separation and transfer device 12, the relay tube 18 is sealed at predetermined intervals to form segment tubes 28.

[0018] The plurality of tubes 30 of the separation processing unit 16 are branched into a plurality of tubes via a branch connector 32 (Y-shaped connector: branch portion). In detail, the plurality of tubes 30 include 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 third tube 38 connecting the drug solution bag 26 and the branch connector 32. 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.

[0019] 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, and 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 are connected to one another by internal flow paths (not shown), which connect the flow paths of the first tube 34, the second tube 36, and the third tube 38 to one another.

[0020] A rupturable sealing member 40 is provided at the end of the first tube 34 on the blood bag 22 side, and the internal flow path is opened when the user ruptures the sealing member 40. Similarly, a rupturable sealing member 42 is provided at the end of the third tube 38 on the drug solution bag 26 side. The sealing members 40, 42 block the first flow path 34a and the third flow path 38a, respectively, until the rupturing operation is performed, and prevent the blood in the blood bag 22 or the additive solution in the drug solution bag 26 from being transferred to another bag 20.

[0021] The blood bag system 10 also includes a pressure on-off valve 100 provided in 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 user operation, allowing the third flow path 38a of the third tube 38 to be switched between an open state and a closed state. The pressure on-off valve 100 is closed in an initial state, blocking the second flow path 36a of the second tube 36. When a fluid pressure equal to or greater than the opening pressure acts on the pressure on-off valve 100, the pressure on-off valve 100 opens the second flow path 36a. Details of the pressure on-off valve 100 will be described later.

[0022] On the other hand, the centrifugal separation and transfer device 12 in which the separation processing unit 16 of the blood bag system 10 is set comprises a box-shaped base 44, a lid 46 that can open and close the top surface of the base 44, and a centrifugal drum 48 provided on the base 44. The base 44 of the centrifugal separation and transfer device 12 is also provided with a motor (not shown) that rotates the centrifugal drum 48, a control unit 50 that controls the operation of the centrifugal separation and transfer device 12, and an operation display unit 52 that the user can check and operate.

[0023] The centrifugal drum 48 has a plurality of (six) unit setting areas 54 in which the separation processing units 16 can be set. The height of one unit setting area 54 is longer than the longitudinal length of the bag 20, and is set within a range of 60° with respect to the rotation center of the centrifugal drum 48. In other words, the six unit setting areas 54 are lined up without gaps along the circumferential direction to form the centrifugal drum 48, which is an annular structural part.

[0024] As shown in FIG. 2, the unit set area 54 includes a blood bag pocket 56 for accommodating the blood bag 22, a PPP bag pocket 58 for accommodating the PPP bag 24, and a drug solution bag pocket 60 for accommodating the drug solution bag 26, all located radially outward of the centrifugal drum 48.

[0025] The blood bag pocket 56 is provided in the circumferential center of the unit set area 54, and has a larger capacity than 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 radially outward of the blood bag pocket 56 and lined up in the circumferential direction.

[0026] The upper surface 54a of the unit set area 54 is configured to arrange and hold the multiple tubes 30 of the blood bag system 10. The first tube 34 and a portion of the segment tube 28 are arranged in a central region 54a1 of the upper surface 54a, which is radially inward of the blood bag pocket 56. A lid 62 that opens and closes the opening of the blood bag pocket 56 is also provided in the central region 54a1. Furthermore, at the arrangement position of the first tube 34 closed by the lid 62, a portion of a breaking portion 64 that breaks the sealing member 40 and a sensor 66 that detects the state of blood flowing through the first tube 34 are provided.

[0027] A portion of the first tube 34 that passed through the central region 54a1, the branch connector 32, and portions of the second tube 36 and third tube 38 are disposed in a left region 54a2 of the top surface 54a. A holder 150 that holds the branch connector 32, a PPP clamp 70 that opens and closes the second flow path 36a of the second tube 36, and a chemical clamp 72 that opens and closes the third flow path 38a of the third tube 38 are provided in this left region 54a2.

[0028] A segment pocket 74 for accommodating a plurality of sealing tubes 28a (see FIG. 1) of the segment tube 28 is provided in a right region 54a3 of the upper surface 54a.

[0029] Furthermore, a tube holding portion 76 that protrudes above the upper surface 54a is provided radially outward of the PPP bag pocket 58 and the drug 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 positioned.

[0030] The unit set area 54 also includes a slider 82 that presses the blood bag 22 after centrifugation, located radially inside the blood bag pocket 56. The slider 82 moves forward and backward along the radial direction of the centrifugal drum 48 under the control of the control unit 50 (see FIG. 1).

[0031] In the unit set area 54, the user places the blood bag 22 containing removed blood in the blood bag pocket 56, the empty PPP bag 24 in the PPP bag pocket 58, and the medicinal solution bag 26 containing medicinal solution in the medicinal solution bag pocket 60. Then, in the unit set area 54, the removed blood in the blood bag 22 is centrifuged by rotation of the centrifugal drum 48, and after centrifugation, the slider 82 advances to press the blood bag 22. As a result, the PPP generated by centrifugation in the blood bag 22 is transferred to the PPP bag 24, and after the transfer of the PPP, RBCs remain in the blood bag 22. After the transfer of the PPP, the user removes the blood bag system 10 from the centrifugal transfer device 12.

[0032] Next, the pressure on-off valve 100 of the blood bag system 10 according to this embodiment will be described with reference to FIGS.

[0033] 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 open due to the fluid pressure generated when the blood bag 22 is pressurized by the centrifugal separation and transfer device 12. Furthermore, the pressure on-off valve 100 is configured to close again when the fluid pressure drops.

[0034] Specifically, as shown in Fig. 4, the pressure on-off valve 100 includes a cylindrical housing 84 made of a resin material or a 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 cavity 84a is formed inside the housing 84. A valve element 90 is disposed in the cavity 84a. The valve element 90 is made of a soft elastic material such as rubber or elastomer.

[0035] As shown in Fig. 5, the valve element 90 has a disk-shaped valve body 92 and a support portion 94 that protrudes from the peripheral edge of the valve body 92 to one side in the thickness direction of the valve body 92 (axial direction). The support portion 94 is formed as a circular wall that protrudes along the peripheral edge 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 element 90 from shifting position even when pressure is applied.

[0036] 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 of ​​the first connection port 86 and an area on the side of the second connection port 88 in an airtight and liquidtight manner. As shown in Fig. 5, a slit 96 consisting of a linear cut that penetrates the valve body 92 in the thickness direction is formed in the center of the valve body 92. The slit 96 is formed in a line that passes through the central axis of the disc-shaped valve body 92 when viewed from the front.

[0037] When no pressure is applied, the slit 96 is tightly closed, preventing the passage of fluid. When pressure is applied, the valve body 92 elastically deforms, creating a gap in the slit 96, allowing the valve body 92 to deform into an open state that allows the passage of fluid. The pressure at which the valve element 90 opens (opening pressure) can be set appropriately 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.

[0038] The opening pressure of valve element 90 is preferably set to a value that will not open due to the pressure generated when the additive solution in medicinal solution bag 26 is transferred under gravity to blood bag 22. As a result of research conducted by the present inventors, the pressure generated during gravity flow of medicinal solution bag 26 is generally about 1.7 kPa, although it varies depending on the height between medicinal solution bag 26 and valve element 90. Furthermore, the pressure generated when medicinal solution bag 26 is lightly gripped during handling is about 3.3 kPa, and the pressure generated when medicinal solution bag 26 is tightly gripped is about 8 kPa.

[0039] Therefore, from the viewpoint of preventing unintentional opening during handling, the opening pressure should be higher than 1.7 kPa, and the opening pressure of the valve element 90 is preferably a pressure that does not open until it is at least lightly squeezed (e.g., 3.3 kPa or higher). However, if the opening pressure of the valve element 90 is too high, the valve element 90 will not open due to the pressurization of the blood bag 22 of the centrifugal separation and transfer device 12. Therefore, the upper limit of the opening pressure is preferably equal to or lower than the upper limit of the pressure generated by the centrifugal separation and transfer device 12 (e.g., 200 kPa). Furthermore, after the transfer of the plasma components, the user performs an operation to remove air bubbles from the PPP bag 24. If the opening pressure of the valve element 90 is too high, it becomes difficult for the user to remove air bubbles. Therefore, it is more preferable that the upper limit of the opening pressure be equal to or lower than the pressure that can be generated by tightly squeezing the PPP bag 24 (e.g., 8 kPa). A pressure of 3.3 kPa to 6 kPa is more preferable from the viewpoint of preventing mixing of the plasma components and the additive solution and for air removal.

[0040] The number of slits 96 is not limited to one, and multiple slits 96 may be provided radially around the central axis as shown in the modified example of Fig. 6. The pressure on-off valve 100 described above is connected midway through the second tube 36 as shown in Fig. 3. Although not particularly limited, the pressure on-off valve 100 can be connected to the second tube 36 near the branch connector 32.

[0041] 3, the holder 150 has a connector holder 152 that holds the branch connector 32 and a clamp holder 154 that holds the clamp 37. The pressure on-off valve 100 is disposed near the holder 150 together with the branch connector 32 when the blood bag system 10 is set to the centrifugal separation and transfer device 12.

[0042] The connector holding portion 152 is formed in a cylindrical shape and has a Y-shaped holding groove 152a cut out to a predetermined depth from the upper end, so that the branch connector 32 can be fitted in from the outside.

[0043] In manufacturing the above 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. Then, the valve body 92 is placed in the housing 84, and the first connection port 86 and the second connection port 88 are connected to manufacture the pressure on-off valve 100. When assembling the blood bag system 10, the pressure on-off valve 100 is connected to the second tube 36, and a clamp 37 is attached to the third tube 38. Thereafter, the second tube 36 and the third tube 38 are fixed to the branch connector 32. In this way, the blood bag system 10 having the pressure on-off valve 100 is formed.

[0044] The blood bag system 10 according to the first embodiment is basically configured as described above, and its operation will be described below together with the blood processing method.

[0045] In the method of processing blood using the blood bag system 10, the user sequentially performs a workflow consisting of 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 removal step (step S6), a suspension step (step S7), an additive solution injection step (step S8), and a seal separation step (step S9), as shown in FIG. 7.

[0046] In the blood collection step (step S1), the user collects whole blood from a donor using a blood collection needle in a pretreatment unit (not shown) and stores it in a blood collection bag. Next, in the leukocyte removal step (step S2), the user transfers the whole blood from the blood collection bag to the blood bag 22. At this time, the whole blood passes through a filter, and the removed blood, from which leukocytes have been removed, is stored in the blood bag 22.

[0047] In order to centrifuge the removed blood, in the device setting step (step S3), the user separates the separation processing unit 16 of the blood bag system 10 from the pre-processing unit and sets it in the centrifugal transfer device 12. As shown in FIG. 2, the user places the blood bag 22 in the blood bag pocket 56 of the unit setting area 54 and sets the first tube 34, the second tube 36, and the third tube 38 along a predetermined path on the upper surface 54a of the unit setting area 54. The first tube 34 is routed along a predetermined path in the central region 54a1 and then positioned toward the left region 54a2. Furthermore, the user routes the first tube 34, the second tube 36, and the third tube 38 in the left region 54a2 and holds the branch connector 32 and the clamp 37 in the holder 150.

[0048] The second tube 36 extends from the branch connector 32 through the left region 54a2 toward the outside in the centrifugal direction and is arranged to pass through the PPP clamp 70. The second tube 36 is further accommodated in the guide groove 78 of the tube holding portion 76 radially outside the medicinal solution bag pocket 60. The third tube 38 also extends from the branch connector 32 through the left region 54a2 toward the outside in the centrifugal direction and is arranged to pass through the medicinal solution clamp 72. The user then accommodates the PPP bag 24 connected to the second tube 36 in the PPP bag pocket 58, and the medicinal solution bag 26 connected to the third tube 38 in the medicinal solution bag pocket 60. This completes the installation of the blood bag system 10 in the centrifuge transfer device 12.

[0049] 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. After the device setting step (step S3), the pressure on-off valve 100 closes the second flow path 36a of the second tube 36.

[0050] Thereafter, in the centrifugation step (step S4), the centrifugal separation device 12 rotates the centrifugal drum 48 under the control of the control unit 50, thereby centrifuging the removed blood from the blood bag 22 into blood components such as PPP and RBC, which have different specific gravities. During centrifugation, the second tube 36 and the third tube 38 are closed by a PPP clamp 70 and a drug solution clamp 72 (both see FIG. 2), suppressing the flow of blood components.

[0051] In the plasma component transfer step (step S5), the centrifugal separation device 12 releases only the PPP clamp 70 and presses the blood bag 22 with the slider 82. This opens the pressure on-off valve 100 provided in the second tube 36, as shown in FIG. 8A. The PPP in the blood bag 22 then flows through the first tube 34, the branch connector 32, and the second tube 36 in this order, and enters the PPP bag 24.

[0052] After the plasma component transfer step (step S5), the pressure in the second flow path 36a drops, causing the pressure on-off valve 100 to close, so that the second flow path 36a and the third flow path 38a return to their closed states.

[0053] Next, in the device removal step (step S6) of Fig. 7, the centrifugal separation and transfer device 12 retracts the slider 82 and releases the chemical solution clamp 72 (see Fig. 2), thereby enabling the blood bag system 10 to be removed from the centrifugal separation and transfer device 12. The user closes the third flow path 38a of the third tube 38 with the clamp 37. Thereafter, the user removes the blood bag system 10. Then, in the hanging step (step S7), the user hangs the chemical solution bag 26 on a stand (not shown), and further positions the blood bag 22 below the chemical solution bag 26 in the direction of gravity.

[0054] Next, in the additive solution injection step (step S8), the user opens the third tube 38 and breaks the sealing member 42, thereby supplying the additive solution from the drug solution bag 26 to the blood bag 22, as shown in FIG. 8B. At this time, the user deforms the clamp 37 to open the third flow path 38a. As a result, the additive solution from the drug solution bag 26 is injected into the blood bag 22 through the third tube 38 and the first tube 34. A pressure corresponding to the head difference between the second tube 36 and the drug solution bag 26 acts on the pressure on-off valve 100 of the second tube 36. However, because this pressure is lower than the opening pressure of the pressure on-off valve 100, the pressure on-off valve 100 remains closed. Therefore, according to this embodiment, the additive solution can be prevented from entering the PPP bag 24 without providing the clamp 37 on the second tube 36.

[0055] In the sealing and separating step (step S9) after the additive solution injection step (step S8), the user seals and cuts the first tube 34 at an appropriate position. This separates the blood bag 22 from the blood bag system 10 with RBCs containing the additive solution stored therein. Similarly, the user seals and cuts the second tube 36 on the PPP bag 24 side relative to the pressure on-off valve 100. This separates the PPP bag 24 from the blood bag system 10 with PPP stored therein. The remaining blood bag system 10, including the pressure on-off valve 100, is then appropriately discarded.

[0056] The present invention is not limited to the above-described embodiment, and various modifications are possible within the spirit and scope of the invention. For example, as shown in Fig. 9, like a pressure on-off valve 100 of a blood bag system 10, the valve body 92 may be disposed in the second flow path 36a of the second tube 36A, and the pressure on-off valve 100 may be integrated with the second tube 36A.

[0057] Furthermore, for example, like a pressure on-off valve 100 shown in FIG. 10, the valve body 92 may be disposed inside the branch connector 32A, and the pressure on-off valve 100 may be integrated with the branch connector 32A.

[0058] The blood bag system 10 of this embodiment has the following advantages.

[0059] The blood bag system 10 of this embodiment includes a first bag (e.g., blood bag 22) for storing blood, a second bag (e.g., PPP bag 24) for storing blood components obtained by centrifuging the blood in the first bag, a third bag (e.g., drug solution bag 26) for storing an additive solution, 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, a branching section (e.g., branching connector 32) connecting the first tube 34, the second tube 36, and the third tube 38, and a pressure on-off valve 100 provided on a flow path (e.g., second flow path 36a) passing through the second tube 36 or on a flow path leading to the second tube 36 inside the branching section, which closes the flow path and opens the flow path when the pressure in the flow path reaches or exceeds a predetermined opening pressure.

[0060] According to the above configuration, manual clamp 37 requires only one of second tube 36 and third tube 38, eliminating the need to open and close two clamps, improving operability for the user. Also, since the user can concentrate on opening and closing one clamp 37, erroneous operation of clamp 37 is less likely to occur.

[0061] In the above-described blood bag system 10, the pressure on-off valve 100 may be provided on the flow path passing through the third tube 38 or on the flow path leading to the third tube 38 at the branched portion.

[0062] In the above-described blood bag system 10, the pressure on-off valve 100 may be provided in the second tube 36, and the opening pressure of the pressure on-off valve 100 may be set higher than the pressure of the additive solution acting due to the difference in pressure between the third bag and the pressure on-off valve 100. With this configuration, in the blood bag system 10, during the operation of injecting the additive solution from the third bag to the first bag, which is performed after the centrifugation step, the pressure on-off valve 100 is kept closed, thereby preventing the additive solution from flowing into the second tube 36. In other words, it is not necessary to attach the clamp 37 to the second tube 36. This improves operability for the user.

[0063] In the above blood bag system 10, 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.

[0064] In the above-described blood bag system 10, the opening pressure of the pressure on-off valve 100 may be 200 kPa or less. With this configuration, the pressure on-off valve 100 opens reliably when the blood components are transferred from the first bag to the second bag, thereby ensuring the transfer of the blood components.

[0065] In the above-described blood bag system 10, the pressure on-off valve 100 may be provided inside the branch portion. This configuration simplifies the device configuration and improves ease of handling.

[0066] In the above-described blood bag system 10, the pressure on-off valve 100 may be provided inside the second tube 36 or the third tube 38. According to this configuration, the device configuration is simplified and handling is improved.

[0067] In the above-mentioned blood bag system 10, the pressure on-off valve 100 may have a plate-shaped (e.g., disc-shaped) valve body 92 that blocks the flow path, a support portion 94 that abuts the wall surface of the flow path, and a slit 96 that passes through the central axis of the valve body 92 and penetrates the valve body 92 in the thickness direction.

[0068] In the above-described blood bag system 10, a plurality of slits 96 may be provided radially.

[0069] In the above-described blood bag system 10, the thickness of the valve body 92 in the axial direction of the flow path may be thinner than the thickness of the support part 94 in the axial direction of the flow path. With this configuration, the valve body 92 can deform and open / close in response to pressure.

[0070] In the above blood bag system 10, the pressure on-off valve 100 may be made of rubber or elastomer.

[0071] The blood processing method of this embodiment is a blood processing method using the above-mentioned blood bag system 10, and includes the steps of 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 100 and transfer some of the blood components to the second bag, and transferring the additive solution in the third bag to the first bag by gravity flow.

[0072] According to the above-described blood processing method, the user can concentrate on opening and closing one clamp 37, thereby preventing erroneous opening and closing.

[0073] The above-mentioned blood processing method may further include the steps of blocking the third tube with a clamp after the step of separating the blood in the first bag into blood components under the action of centrifugal force, and removing the clamp from the third tube after releasing the pressure on the first bag.

[0074] Although the present invention has been described above by citing preferred embodiments, it goes without saying that the present invention is not limited to the above embodiments, and various modifications are possible within the scope of the present invention.

Claims

1. a first bag for containing blood; a second bag for storing 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 branch portion connecting the first tube, the second tube, and the third tube; a pressure on-off valve that is provided on a flow path passing through the second tube or on a flow path leading to the second tube inside the branch portion, and that closes the flow path and opens the flow path when the pressure in the flow path reaches or exceeds a predetermined opening pressure; Equipped with The pressure on-off valve is a plate-shaped valve body that closes the flow path; a support portion that abuts against a wall surface of the flow path; a slit passing through the central axis of the valve body and penetrating the valve body in a thickness direction, The blood bag system further comprises a clamp attached to the third tube.

2. 2. 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 leading to the third tube inside the branched portion.

3. 3. The blood bag system according to claim 1, wherein the opening pressure of the pressure on-off valve is higher than the pressure of the additive solution acting due to a head difference between the third bag and the pressure on-off valve.

4. 4. The blood bag system according to claim 1, wherein the opening pressure of the pressure on-off valve is 3.3 kPa or more.

5. 5. The blood bag system according to claim 1, wherein the opening pressure of the pressure on-off valve is 200 kPa or less.

6. 6. The blood bag system according to claim 1, wherein the pressure on-off valve is provided inside the branch portion.

7. 7. The blood bag system according to claim 1, wherein a plurality of the slits are provided radially.

8. 8. The blood bag system according to claim 1, wherein the axial thickness of the flow path of the valve body is thinner than the axial thickness of the support portion.

9. 9. The blood bag system according to claim 1, wherein the pressure on-off valve is made of rubber or elastomer.

10. A method for treating blood 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; a step of 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 from the third bag to the first bag by gravity flow; A blood processing method comprising the steps of:

11. 11. The method for treating blood according to claim 10, After the step of separating the blood in the first bag into blood components under the action of centrifugal force, occluding the third tube with the clamp; removing the clamp from the third tube after depressurizing the first bag; The method for treating blood further comprises:

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