JP7807428B2 - Blood bag system and blood processing method - Google Patents

Description

The present invention relates to a blood bag system used for separating blood components and a method for processing blood.

JP 2016-106012 A discloses a blood bag system comprising 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, with the first to third tubes connected to each other by a branch (Y-shaped connector).

When the blood bag system is set into a centrifuge transfer device 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, second, and third bags. After transferring the blood components from the first bag to the second bag, the user closes the flow path of the second tube with the first clamp and the flow path of the third tube with the second clamp. In this state, the user removes the blood bag system from the centrifuge transfer device and suspends it on the 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.

Conventional blood bag systems require users to operate two clamps, making clamp operation cumbersome and increasing the risk of incorrect operation, such as removing the wrong clamp.

The present invention has been made in consideration of the above-mentioned problems, and aims to provide a blood bag system and a blood processing method that facilitates clamp operation and prevents incorrect clamp operation.

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 leading to 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.

Another aspect is a method for processing 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.

According to the blood bag system and blood processing method described above, by replacing one of the two conventional clamps with a pressure opening/closing valve, the number of clamps can be reduced to just one, making operation easier and preventing the user from operating the clamp incorrectly.

1 is an explanatory diagram showing the overall configuration of a blood bag system and a centrifugal separation system according to a first embodiment. [0022] FIG. FIG. 10 is a plan view showing a unit set area of the centrifugal component transfer device. 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. FIG. 2 is a cross-sectional view of a pressure on-off valve. FIG. 5 is a cutaway perspective view of the valve body of the pressure on-off valve of FIG. 4 . 5 is a plan view showing a modified example of the slit of the pressure on-off valve of FIG. 4. FIG. 2 is a flowchart showing a method for treating blood 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, and FIG. 8B is an explanatory diagram showing the flow of the additive solution when the additive solution is transferred under gravity flow. FIG. 10 is a cross-sectional view showing a modified example (part 1) of the application portion of the pressure on-off valve. FIG. 10 is a cross-sectional view showing a modified example (part 2) of the application portion of the pressure on-off valve.

Below, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings.

(First embodiment)
A blood bag system 10 according to a first embodiment of the present invention is set in a centrifugal separation device 12 by a user such as a medical professional, as shown in Figure 1. The centrifugal separation device 12 centrifuges the blood in the blood bag system 10 to generate a plurality of 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 device 12 will be referred to as a centrifugation system 14.

The blood bag system 10 comprises 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, leaving the separation treatment section 16 in the state shown in Figure 1, and it is then set in the centrifugation transfer device 12.

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, blood collection bag, initial blood bag, and filter (e.g., a white blood cell removal filter), all of which are not shown, and is configured by connecting these components via multiple tubes 30. Specifically, the pretreatment section stores the initial portion of the donor's whole blood collected through the blood collection needle in the initial blood bag, and then stores the remaining blood in the blood collection bag. Furthermore, the pretreatment section passes the whole blood stored in the blood collection bag through a filter, thereby removing white blood cells in the filter. The blood after white blood cell removal is then transferred via a relay tube 18 to the separation processing section 16, which is connected to the filter.

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

In the supplied state of the blood bag system 10, the blood bag 22 is directly connected to the relay tube 18 connected 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 with different specific gravities, such as platelet-poor plasma (PPP) and red blood cells (RBC). 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.

The PPP bag 24 is a second bag (plasma bag) that receives PPP from the blood bag 22 and stores the PPP in the second storage space 24a. Meanwhile, the drug solution bag 26 is a third bag that pre-stores a red blood cell preservative solution (hereinafter referred to as additive solution) such as MAP solution, SAGM solution, or OPTISOL in the third storage space 26a.

In addition, before the separation processing unit 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.

The multiple tubes 30 of the separation processing unit 16 branch into multiple paths via a branch connector 32 (Y-shaped connector: branch section). In detail, the multiple tubes 30 include a first tube 34 connecting the blood bag 22 to the branch connector 32, a second tube 36 connecting the PPP bag 24 to the branch connector 32, and a third tube 38 connecting the drug solution bag 26 to 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.

The branch connector 32 also 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, with the first port 32a, second port 32b, and third port 32c being integrally molded. The first port 32a, second port 32b, and third port 32c are interconnected by internal flow paths (not shown), thereby interconnecting the flow paths of the first tube 34, second tube 36, and third tube 38.

A rupturable sealing member 40 is provided at the end of the first tube 34 facing the blood bag 22, and the internal flow path is opened when the user ruptures it. Similarly, a rupturable sealing member 42 is provided at the end of the third tube 38 facing the drug solution bag 26. The sealing members 40, 42 block the first flow path 34a and the third flow path 38a, respectively, until the rupture operation is performed, preventing the transfer of blood in the blood bag 22 or the additive solution in the drug solution bag 26 to another bag 20.

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 opens and closes based on user operation, allowing the third flow path 38a of the third tube 38 to be switched between an open and closed state. The pressure on-off valve 100 is initially closed, blocking the second flow path 36a of the second tube 36. When fluid pressure equal to or greater than the opening pressure acts on the pressure on-off valve 100, it opens the second flow path 36a. Details of the pressure on-off valve 100 will be described later.

On the other hand, the centrifugal separation and transfer device 12, on 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 attached to 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.

The centrifugal drum 48 has multiple (six) unit set areas 54 in which the separation processing units 16 can be set. The height of each unit set area 54 is longer than the longitudinal length of the bag 20 and is set within a 60° range from the center of rotation of the centrifugal drum 48. In other words, the six unit set areas 54 are lined up tightly around the circumference to form the centrifugal drum 48, which is an annular structural part.

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

The blood bag pocket 56 is located in the circumferential center of the unit set area 54 and has a larger volume 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 located radially outward of the blood bag pocket 56 and are aligned circumferentially.

The upper surface 54a of the unit set area 54 is configured to hold and accommodate 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, radially inward from 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 position of the first tube 34 closed by the lid 62, a portion of a rupturing portion 64 that ruptures the sealing member 40 and a sensor 66 that detects the state of blood flowing through the first tube 34 are provided.

The left region 54a2 of the top surface 54a is where 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 located. This left region 54a2 is provided with 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.

The right region 54a3 of the upper surface 54a is provided with a segment pocket 74 that accommodates multiple sealing tubes 28a (see Figure 1) of the segment tube 28.

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 in the unit set area 54. The tube holding portion 76 has a guide groove portion 78 in which the second tube 36 is positioned.

The unit set area 54 also includes a slider 82 located radially inside the blood bag pocket 56, which presses against the blood bag 22 after centrifugation. 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 Figure 1).

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. The unit set area 54 then centrifuges the removed blood from the blood bag 22 by rotating the centrifugal drum 48, and after centrifugation, advances the slider 82 to press against 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 RBCs remain in the blood bag 22 after the PPP has been transferred. After the PPP has been transferred, the user removes the blood bag system 10 from the centrifugal transfer device 12.

Next, the pressure on-off valve 100 of the blood bag system 10 of this embodiment will be described with reference to Figures 3 to 6.

As described above, the pressure on-off valve 100 is attached to the second tube 36 of the blood bag system 10 and blocks 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. The pressure on-off valve 100 is also configured to close again when the fluid pressure decreases.

Specifically, as shown in Figure 4, the pressure on-off valve 100 includes a cylindrical housing 84 made of a resin 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 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.

As shown in Figure 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 Figure 4, the support portion 94 is in close contact with the inner wall of the housing 84, preventing the valve element 90 from shifting position even when pressure is applied.

The valve body 92 is formed to have the same shape as the cross section of the cavity 84a, and divides the cavity 84a into an area adjacent to the first connection port 86 and an area adjacent to the second connection port 88 in an airtight and liquid-tight manner. As shown in Figure 5, a slit 96 consisting of a linear cut that penetrates the thickness of the valve body 92 is formed in the center of the valve body 92. When viewed from the front, the slit 96 is formed in a line that passes through the central axis of the disc-shaped valve body 92.

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 it 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 depending on 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 element 90 is preferably set to a value that will not open due to the pressure generated when the additive solution in the drug solution bag 26 is transferred to the blood bag 22 under gravity flow. Research conducted by the inventors of the present application has shown that the pressure generated during gravity flow of the drug solution bag 26 is approximately 1.7 kPa, although this varies depending on the height between the drug solution bag 26 and the valve element 90. Furthermore, the pressure generated when the drug solution bag 26 is lightly gripped while handling it is approximately 3.3 kPa, and the pressure generated when the drug solution bag 26 is tightly gripped is approximately 8 kPa.

Therefore, from the perspective of preventing unintended 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 plasma components, the user removes 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 perspective of preventing mixing of the plasma components and the additive solution and facilitating the air removal operation.

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

As shown in Figure 3, the holder 150 has a connector holding portion 152 that holds the branch connector 32 and a clamp holding portion 154 that holds the clamp 37. The pressure on-off valve 100 is positioned near the holder 150 together with the branch connector 32 when the blood bag system 10 is set to the centrifuge transfer device 12.

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, and is configured to allow the branch connector 32 to be fitted in from the outside.

When 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 tube 30. The valve body 92 is then placed in the housing 84, and the pressure on-off valve 100 is manufactured by connecting the first connection port 86 and the second connection port 88. 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. The second tube 36 and the third tube 38 are then fixed to the branch connector 32. This completes the formation of the blood bag system 10 having the pressure on-off valve 100.

The blood bag system 10 of the first embodiment is basically configured as described above, and its operation will be explained below along with the blood processing method.

The method of processing blood using the blood bag system 10 is carried out by the user in the following order: blood collection step (step S1), leukocyte removal step (step S2), device setting step (step S3), centrifugation step (step S4), plasma component transfer step (step S5), device removal step (step S6), suspension step (step S7), additive solution injection step (step S8), and seal separation step (step S9), as shown in Figure 7.

In the blood collection step (step S1), the user collects whole blood from the donor using a blood collection needle in the 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.

In order to centrifuge the removed blood, in the device setting step (step S3), the user disconnects 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, second tube 36, and 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, second tube 36, and third tube 38 in the left region 54a2 and holds the branch connector 32 and clamp 37 in the holder 150.

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

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

Then, 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 separating the removed blood from the blood bag 22 into blood components with different specific gravities, such as PPP and RBC. During centrifugation, the second tube 36 and the third tube 38 are blocked by the PPP clamp 70 and the drug solution clamp 72 (both see Figure 2), suppressing the flow of blood components.

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 Figure 8A. The PPP in the blood bag 22 then flows sequentially through the first tube 34, branch connector 32, and second tube 36, and into the PPP bag 24.

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. Therefore, the second flow path 36a and the third flow path 38a return to their closed states.

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

Next, in the additive solution injection step (step S8), the user opens the third tube 38 and ruptures 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. This allows the additive solution from the drug solution bag 26 to be injected into the blood bag 22 through the third tube 38 and the first tube 34. Pressure corresponding to the head difference with 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 being mixed into the PPP bag 24 without providing a clamp 37 on the second tube 36.

In the sealing and separating step (step S9) following 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 inside. 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 inside. The remaining blood bag system 10, including the pressure on-off valve 100, is then appropriately discarded.

The present invention is not limited to the above-described embodiment, and various modifications are possible in accordance with the spirit of the invention. For example, as shown in Figure 9, like the pressure on-off valve 100 of the 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.

Furthermore, for example, as in the pressure on-off valve 100 shown in Figure 10, the valve body 92 may be positioned 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 comprises a first bag (e.g., blood bag 22) for containing blood, a second bag (e.g., PPP bag 24) for containing blood components obtained by centrifuging the blood in the first bag, a third bag (e.g., drug solution bag 26) containing 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 branch (e.g., branch connector 32) connecting the first tube 34, the second tube 36, and the third tube 38, and a pressure on-off valve 100 located on a flow path (e.g., second flow path 36a) through the second tube 36 or on a flow path inside the branch leading to the second tube 36, which closes the flow path and opens the flow path when the pressure in the flow path reaches or exceeds a predetermined opening pressure.

With the above configuration, the manual clamp 37 requires only one of the second tube 36 and the third tube 38, eliminating the need to open and close two clamps, improving user operability. Furthermore, since the user can concentrate on opening and closing one clamp 37, incorrect operation of the clamp 37 is less likely to occur.

In the above blood bag system 10, the pressure on-off valve 100 may be provided in the flow path through the third tube 38 or in the flow path toward the third tube 38 at the branch point.

In the above-described blood bag system 10, the pressure on-off valve 100 is provided in the second tube 36, and the opening pressure of the pressure on-off valve 100 may be 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 injection operation of 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, there is no need to attach a clamp 37 to the second tube 36. This improves user operability.

In the above blood bag system 10, the opening pressure of the pressure on-off valve 100 may be 3.3 kPa or more. This configuration effectively prevents the additive solution from being mixed into the second bag.

In the above-described blood bag system 10, the opening pressure of the pressure on-off valve 100 may be 200 kPa or less. By configuring it in this manner, the pressure on-off valve 100 reliably opens when transferring blood components from the first bag to the second bag, ensuring reliable transfer of blood components.

In the above blood bag system 10, the pressure on-off valve 100 may be provided inside the branch section. This configuration simplifies the device configuration and improves ease of use.

In the above-mentioned blood bag system 10, the pressure on-off valve 100 may be provided inside the second tube 36 or the third tube 38. This configuration simplifies the device configuration and improves ease of use.

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.

In the above blood bag system 10, multiple slits 96 may be provided radially.

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

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

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.

The above blood processing method allows the user to concentrate on opening and closing one clamp 37, preventing incorrect opening and closing.

The above-mentioned blood processing method may further include a step 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 the centrifugal force, and a step of removing the clamp from the third tube after releasing the pressure on the first bag.

The present invention has been described above using preferred embodiments, but it goes without saying that the present invention is not limited to the above embodiments and that various modifications are possible within the scope of the present invention.

Claims (11)

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. 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. A blood bag system according to claim 1 or 2, wherein the opening pressure of the pressure on-off valve is higher than the pressure of the additive solution acting due to the head difference between the third bag and the pressure on-off valve. 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. 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. The blood bag system according to any one of claims 1 to 5, wherein the pressure on-off valve is provided inside the branch portion. 7. The blood bag system according to claim 1 , wherein a plurality of the slits are provided radially. 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. The blood bag system according to claim 1 , wherein the pressure on-off valve is made of rubber or elastomer. 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. 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: