Blood package processing device, blood package processing system, and blood package processing method

RU2870867C2Active Publication Date: 2026-09-28LMB SOFT DOO NIS
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Patent Information

Application Number
RU2025128209
Authority / Receiving Office
RU · RU
Patent Type
Patents
Current Assignee / Owner
Priority Date
2023-03-17
Filing Date
2024-03-15
Publication Date
2026-09-28
Estimated Expiration
2044-03-15

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Abstract

FIELD: medical technology.SUBSTANCE: blood bag processing device is built into the table and contains a blood bag moving unit, which is designed to move blood bags arranged in a specified order, filled with separated blood components, and containing a single blood bag tube that is hermetically sealed or connected to a blood sampling needle. The unit for moving blood component bags is designed to move individual blood component bags connected to a single tube for blood component bags and / or connected via a Y‑shaped connector to the single tube for blood component bags, in accordance with a pre‑defined order of blood bags. The sterile docking unit is designed to enable sterile docking of the tubes of individual blood bags with the single tubes of blood component bags. The docking element is located on the upper surface of the table between the blood bag transfer unit and the blood component bag transfer unit. The working element is located beneath the upper surface of the table and can be accessed through a working opening made in the side surface of the table. The blood bag processing system and the blood bag processing method are disclosed.EFFECT: technical result consists in expanding the functional capabilities.18 cl, 16 dwg
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Description

[0001] The present invention relates to a blood bag processing device, a blood bag processing system and a blood bag processing method.

[0002] Patent EP 1 591 136 A1 discloses a method for collecting and processing whole blood. Prior to centrifugation, a blood bag system is formed with a variable number of component bags, depending on the subsequent processing of the blood components obtained after centrifugation. However, the component bags must be stored in the centrifuge receiver, which can complicate filling and handling the centrifuge receiver.

[0003] The aim of the present invention is therefore to provide an improved method for processing blood bags. This objective is achieved by the objects presented in the independent claims. Preferred embodiments are described in the dependent claims.

[0004] The blood bag processing device proposed in the present invention comprises: a blood bag moving unit configured to move blood bags filled with separated blood components and containing a single tube of blood bags in a predetermined order, hermetically sealed or connected to a blood collection needle; a blood component bag moving unit configured to move individual blood component bags connected to a single main tube of blood component bags and / or several blood component bags connected via a Y-shaped connector to a single main tube of blood component bags, in accordance with a predetermined order of blood bags; and a sterile docking unit configured to sterilely dock the tubes of individual blood bags with the corresponding single main tubes of blood component bags.Thus, the use of a blood bag processor allows for the creation of a blood bag system adapted for further processing of blood components stored in the blood bag and the elimination of unnecessary plastic waste.

[0005] According to one aspect of the present invention, the blood bag processing device can be integrated into a table. Thus, the blood bag processing device can be easily positioned next to a blood separation centrifuge, and blood bags can be transported directly from the blood separation centrifuge to a sterile docking unit via a blood bag transfer unit. Preferably, the table is height-adjustable to create an ergonomic workstation for the operator of the blood bag processing device.

[0006] According to one aspect of the present invention, the table can be mounted on wheels. This allows the owner of the blood bag processing device to move it alongside a separate blood separation centrifuge, thereby increasing productivity.

[0007] According to one aspect of the present invention, a sterile docking unit can be installed between the blood bag transfer unit and the blood component bag transfer unit. Thus, the tubing of a single blood bag and a single main blood component tubing can be easily connected using the sterile docking unit.

[0008] According to one aspect of the present invention, the blood bag transfer unit can be configured to accommodate centrifuge receptacles that store at least one blood bag. Thus, the centrifuge receptacles can be directly transferred from the centrifuge to the blood bag transfer unit, and the blood bags located in the centrifuge receptacle are protected from damage.

[0009] According to one aspect of the present invention, the blood bag transfer unit can be a conveyor belt. Thus, blood bags from the centrifuge receiver can be easily transferred from the blood separation centrifuge to the sterile docking unit, even over long distances. The conveyor belt preferably has receiving portions configured to accommodate one or more centrifuge receivers. This prevents the centrifuge receivers from falling.

[0010] According to one aspect of the present invention, a blood component bag transfer unit can be configured to accommodate a container that stores at least one blood component bag. This prevents tubing connected to multiple blood component bags from becoming tangled or twisted. In particular, the container can be a collapsible, envelope-shaped box. This saves space when storing flat component bags.

[0011] According to one aspect of the present invention, a blood component bag handling unit may comprise slots or grooves configured to accommodate a container so as to transport the container in an upright position. This allows the operator to easily control the containers or boxes being transported.

[0012] According to one aspect of the present invention, containers or boxes can be labeled according to the blood component package being stored. This allows the operator to recognize the blood component package being stored at a glance. For example, the package can be color-coded.

[0013] According to one aspect of the present invention, the blood component bag transfer unit may be a clip. The clip may be rotatable to feed a blood component bag of the appropriate configuration into a sterile docking unit. Alternatively, the clip may be tilted toward the tabletop to allow the operator of the blood component bag processing device to easily grasp the blood component bags. The clip may be configured to store and transfer containers or boxes containing the blood component bag(s).

[0014] According to one aspect of the present invention, the blood component bag transfer unit may be a conveyor belt. Thus, the blood component bag(s) can be easily transferred to a sterile docking unit.

[0015] According to one aspect of the present invention, the blood bag transfer unit and / or the blood component bag transfer unit can be recessed relative to the tabletop surface. Thus, blood bags, centrifuge receivers, blood component bags, or containers / boxes can be reliably transferred into the sterile docking unit.

[0016] According to one aspect of the present invention, the sterile docking unit may comprise a blood bag securing element configured to secure the blood bag and / or a blood component bag securing element configured to secure at least one blood component bag. The holding element may comprise shelves, pins, or a hook. Thus, the bags can be securely secured during docking.

[0017] According to one aspect of the present invention, the docking element of the sterile docking unit can be located on the top surface of the tabletop. This allows easy access to the docking element for inserting the connecting tube. The control element of the sterile docking unit can be located under the top surface of the tabletop. Thus, to perform the docking, the operator only needs to move their hand under the top surface of the tabletop. This reduces the risk of injury from touching the docking element during operation. Furthermore, the control element is accessible only through a working opening formed in the side surface of the tabletop. This further reduces the risk of injury.

[0018] According to one aspect of the present invention, the control element can be configured to be operated by simultaneous touch with both hands. Furthermore, touching the control element is required during the docking process. For example, the control element can be formed by two buttons spaced apart so that they can be operated with only two hands. Locating the control element below the tabletop virtually completely reduces the risk of injury from touching the docking element during operation.

[0019] According to one aspect of the present invention, a sterile docking unit can be configured to sterilely connect the tubing of a separate blood bag to the main tubing of blood component bags using radiofrequency heating. Thus, consumables such as plates or wires are not required, and the tubing can be securely connected.

[0020] According to one aspect of the present invention, the table is shaped on one side such that it can be positioned in close proximity to the blood separation centrifuge. Thus, blood bags or centrifuge receivers can be transferred directly from the blood separation centrifuge to a sterile docking station.

[0021] According to one aspect of the present invention, the blood bag transfer unit is aligned with the rotor of a blood separation centrifuge. Thus, the blood bags only need to be transferred from the rotor to a sterile docking unit.

[0022] According to one aspect of the present invention, the blood bag processing device may further comprise a blood bag identification data acquisition unit configured to acquire corresponding identification information about the blood bags. Thus, processed blood bags can be documented.

[0023] According to one aspect of the present invention, the blood bag processing device may further comprise a printing unit configured to print one or more labels with identification information, which are to be placed on at least one blood component bag. The printer prints the required number of labels for each blood component bag. Thus, identifying information can be applied to the blood component bags.

[0024] According to one aspect of the present invention, the blood component bag moving unit can be configured to move the blood component bag(s) in accordance with the identification information acquired by the blood bag identification information acquiring unit. This ensures that the blood component bags are correctly connected to the corresponding component bags.

[0025] According to one aspect of the present invention, the blood bag processing device may further comprise a monitor displaying identification information and the type of the corresponding at least one blood component bag. Thus, the operator can further monitor the docking process, ensuring the proper use of the blood component bag(s).

[0026] A blood bag processing system according to the present invention comprises: a blood separation centrifuge configured to separate whole blood collected in blood bags into blood components; a blood bag processing device according to the above-mentioned aspects; and a blood component extruder configured to extrude the blood components stored in the blood bags after centrifugation into corresponding blood component bags. In this way, whole blood can be separated into corresponding blood components. After this, the blood bags can be connected to a blood component bag(s) of an appropriate configuration. Finally, the blood components can be transferred to the corresponding blood component bag. In this way, unnecessary plastic waste can be avoided in the event that the donated whole blood is deemed unsuitable for use.

[0027] A method for processing blood bags according to the present invention includes: transporting blood bags filled with separated blood components and containing a single tube of blood bags, hermetically sealed or connected to a blood collection needle, in a predetermined order; transporting individual blood component bags connected to a single main tube of blood component bags, or several blood component bags connected through a Y-shaped connector to the main tube of an individual blood component bag, in accordance with a predetermined order of blood bags; and sterilely joining the individual tubes of a blood bag with the corresponding single main tubes of the blood component bags. Thus, using the method for processing blood bags, it is possible to create a blood bag system adapted for further processing of blood components stored in a blood bag and avoid unnecessary plastic waste.

[0028] A centrifuge receiver according to the present invention comprises: a blood bag accommodating portion formed in the shape of a bowl and configured to accommodate a blood bag filled with whole blood or blood components; and a blood component bag container accommodating portion configured to accommodate and hold a blood component bag(s) or a container containing at least one blood component bag. Thus, the blood bag as well as the blood component bag(s) can be transported using the centrifuge receiver.

[0029] According to one aspect of the present invention, the receiving portion of the blood bag container can be formed by a J-shaped portion extending from below and along the outer contour of the blood bag receiving portion. Thus, the container can be formed into a folding envelope-shaped box, ensuring convenient handling of the component bag(s).

[0030] A centrifuge receiver group according to one aspect of the present invention includes: two centrifuge receivers according to the previous aspects, assembled in such a way that the receiving parts of the container for blood component bags are located at opposite ends of the centrifuge receiver group. Thus, two blood bags and two sets of blood component bags can be transported simultaneously.

[0031] The present invention is described below with reference to the drawings. In the drawings:

[0032] Fig. 1-10 shows a blood bag processing apparatus according to a first embodiment of the present invention, and

[0033] Fig. 11-16 show the steps of the method for processing blood bags, as well as the second and third embodiments of the present invention.

[0034] Fig. 1-10 shows a blood bag processing device according to a first embodiment of the present invention. The blood bag processing device 1 comprises a blood bag moving unit 2, a blood component bag moving unit 4, and a sterile docking unit 6.

[0035] The blood bag transfer unit 2 is formed by a conveyor belt, which is configured to accommodate centrifuge receivers 8 in a separate receiving portion, which can be formed by edges on the conveyor belt. The centrifuge receivers 8 store blood bags in which blood components are stored. Blood components are obtained from whole blood by centrifugation. Blood components include, for example, plasma, buffy coat, and red blood cells. For ease of handling of blood bags during collection or centrifugation, the blood bags contain only one blood bag line connected to a blood collection needle. In this embodiment, the blood collection needle can be removed, and the separate blood bag line can be sealed to prevent the stored blood components from leaking from the single blood bag line.For further processing, blood components stored in the blood bag after centrifugation must be transported into separate blood component bags.

[0036] The blood component bag moving unit 4 is designed to move the boxes 10 that are folded in the shape of an envelope. In particular, the boxes 10 are transported in a vertical position. This is achieved due to the fact that the blood component bag moving unit 4 contains slots or grooves in which the boxes 10 can be placed. The boxes 10 store bags of different types of blood components. The boxes 10 can store the following types of blood component bags: single, three-piece top / bottom, three-piece top / bottom with filter, three-piece top / top, three-piece top / top with filter, four-piece top / bottom, four-piece top / bottom with filter, four-piece top / top, four-piece top / top with filter, five-piece top / bottom, five-piece top / bottom with filter, five-piece top / top, five-piece top / top with filter, two-piece top / bottom, two-piece top / top.All these blood component bags contain a single main blood component bag line, which must be connected to the line of a separate blood component bag. Multiple blood component bags can be connected via a Y-connector and the corresponding lines to the single main blood component bag line.

[0037] A sterile docking unit 6 is used to connect a single main tube of blood component bags and a tube of a separate blood bag. Several sterile docking units are known in the prior art, which use, for example, a heated plate, a heating wire, radiofrequency or induction heating to connect the tubes of blood bags. The present invention uses a sterile docking unit according to German Patent Application No. 102022132053. The content of this application is incorporated herein by reference, and the applicant reserves the right to include features related to the sterile docking unit in this application for further description of the sterile docking unit 6.

[0038] As shown in Fig. 1-10, the blood bag processing device 1 is integrated into a table 20 formed by an upper surface 22 of the table and a table base 24. The upper surface 22 of the table is used to accommodate various components of the blood bag processing device 1, and the table base 24 is designed to accommodate a power supply unit and drives for operating the blood bag processing device 1. A data processing device, such as a computer, can also be accommodated in the table base. The table 20 is preferably mounted on casters 26, which allows it to be moved to a location where it is necessary to connect blood component bags with blood bags. The upper surface 24 of the table can also form a protruding surface 30 protruding relative to the table base 24, which allows a chair 32 to be placed next to the table 20. Thus, the operator of the blood bag processing device 1 can work ergonomically.It is preferable that table 20 has height adjustment.

[0039] If necessary, the unit 2 for moving blood bags and / or the unit 4 for moving blood component bags can be recessed relative to the upper surface 22 of the table in such a way as to prevent unintentional tipping over of the centrifuge receivers 8 and / or boxes 10.

[0040] As shown in more detail in Fig. 6, the sterile docking unit 6 comprises a docking element 12 and an operating element 14 formed by a first button 16 and a second button 18. The docking element 12 is preferably located above the upper surface 22 of the table so that it substantially coincides with the upper surface 22 of the table. The upper surface 22 of the table surrounds the docking element 12, and the operating element 14 is accessible only under the upper surface 22 of the table. Therefore, an operating hole 28 can be formed on the side surface of the table 20, in particular on the side surface of the table base 24 (see Fig. 1). To operate the sterile docking unit 6, the operator must simultaneously press the first and second buttons 16 with both hands. This makes it possible to avoid pinching the docking element 12 by the operator during operation.

[0041] In the immediate vicinity of the sterile docking unit 6, a blood component bag holding unit 34 and / or a blood bag holding unit (not shown) may be located, designed to hold (a bag) of blood component bags and blood bags, respectively. The two holding units may be formed by shelves, pins, or hooks configured to hold bags. The holding units may be mounted, for example, on the upper surface 22 of the table.

[0042] The blood bag processing device 1 is controlled by a data processing unit, which is configured to control drives, which, in turn, drive the blood bag moving unit 2 and the blood component bag moving unit 4. As already mentioned, the data processing unit can be a computer and can be located in the table base 24. The data processing unit comprises a machine-readable storage medium and one or more processors. The storage medium contains instructions that cause the data processing unit to execute the method for processing blood bags and control the blood bag processing device 1, and the one or more processors are configured to execute these instructions and read input signals or generate output signals for controlling the components of the blood bag processing device 1.

[0043] The blood bag processing device 1 preferably includes a barcode scanner 36 as a unit for acquiring identification information about the blood bags. The barcode scanner 36 can be connected to the processing unit via a cable or wireless data transmission. Instead of the barcode scanner 36, an RFID scanner, an NFC scanner, or a Bluetooth device (registered trademark) can be used to acquire the identification information. The identification information may include the serial number of the blood bag, donor information, blood type, time and place of blood donation, destination, and / or the further processing procedure for individual components.

[0044] If necessary, the blood bag processing device 1 may also include a label printer 38 configured to print labels based on previously acquired identification information. The printer prints a number of labels corresponding to the number of component bags used. This ensures that the component bags contain identification information.

[0045] The blood bag processing device 1 may also include a monitor 40 that displays identification information and the required component bag configuration for a specific blood bag. This allows the operator to monitor the blood bag processing process.

[0046] Furthermore, as shown in Fig. 2, a shelf space 42 may be provided on the upper surface 22 of the table for storing empty centrifuge receptacles 44 after connecting the blood bag with the corresponding blood component bags. The shelf space 42 may be located behind the monitor 40, as well as behind the label printer 38 and next to the blood component bag moving unit 4.

[0047] If there is a need to immediately process blood components, for example in the event of an emergency or an approaching expiration date, the blood bag processing device 1 may comprise a side table 46 with an upper shelf 48 and a lower shelf 50. On the upper shelf 48, special centrifuge receivers 54 can be placed, designed for storing a blood bag containing whole blood or blood components, as well as boxes with bags for components.

[0048] Thus, the centrifuge receiver 54 comprises a blood bag accommodating portion formed in the shape of a bowl and configured to accommodate a blood bag filled with whole blood or blood components, and a blood component bag container accommodating portion configured to accommodate and hold a container, in particular a box, containing at least one blood component bag. For example, the receiving portion of the blood bag container may be formed by a J-shaped portion extending from below and along the outer contour of the receiving portion of the blood bag. Thus, the blood component bag container may be stored in a vertical position. Furthermore, multiple centrifuge receivers 54 may form a centrifuge receiver group.In this way, it is possible to form a centrifuge receiver, since the centrifuge receiver only needs to store the filled blood bag, rather than storing component bags in the centrifuge receiver during centrifugation. In this embodiment, the two centrifuge receivers 54 are assembled such that the portions for accommodating the blood component bag containers are located at opposite ends of the centrifuge receiver group.

[0049] After processing the blood bag and the blood component bag of one centrifuge receiver 54, the empty centrifuge receivers 56 can be placed on the lower shelf 50 of the side table 46.

[0050] Next, a method for processing blood bags, as well as the second and third embodiments of the present invention, will be described with reference to Figs. 11-16.

[0051] Figure 11 shows a blood bag processing system 58 according to the present invention. The blood bag processing system 58 comprises a centrifuge 60 for separating blood, a blood bag processing device 1 (shown near a blood bag moving unit 2), and a blood component squeezing device (not shown).

[0052] The blood separation centrifuge is equipped with a rotor containing several centrifuge buckets designed to accommodate centrifuge receivers or groups of centrifuge receivers. Blood bags, and subsequently the centrifuge receivers, are arranged on the rotor in a predetermined order. After centrifugation, when the whole blood initially stored in the bag has been separated into its various components, the centrifuge receivers 8 are placed on the blood bag transfer unit 2 in a predetermined order.

[0053] It should be noted that blood bags can be organized according to various characteristics, such as donation time, blood type, and storage requirements. Since not all blood components need to be used for a given collection, blood bags organized in a specific order are processed differently, which in turn requires different quantities and / or different types of component bags. To reduce the number of component bags, it is advisable to combine blood bags with blood component bags of a specific configuration.

[0054] As shown in Fig. 12 and 13, the centrifuge receivers 8, in which the blood bags are stored, are transported from the blood separation centrifuge 60 to the sterile docking unit 6 through the blood bag moving unit 2 in a predetermined order. As shown, the blood bag moving unit 2 is formed by a conveyor belt. On the other side of the sterile docking unit 6, a blood component bag moving unit 62 is located, configured to move at least one blood component bag in accordance with a predetermined order. This can be accomplished either by manually sorting the blood component bags, or by configuring the blood component bag moving unit so that it transports a blood component bag of a certain configuration in accordance with an input signal, which can correspond to previously received identification information about the blood bag.

[0055] According to the second embodiment shown in Figs. 13 and 14, the blood component bag moving unit 62 comprises a holder 64 in which the blood component bags are stored in a proper order. As shown by the arrows next to the blood component bag moving device 62, the blood component bags can be moved toward the upper surface of the table using a spring, which allows the operator of the device 1 to easily grasp the upper blood component bag. As in the previous embodiment, the blood component bags can also be transported using boxes, which facilitates the handling of the blood component bags. After that, as shown in Fig. 14, the tube of the individual blood component bag and the single main tube of the blood component bags are connected using a sterile docking unit 6.

[0056] Figures 15 and 16 show a blood bag processing device 1 according to a third embodiment of the present invention. In the third embodiment, the blood component bag moving unit 64 is also configured as a conveyor belt. As shown in Figure 16, the blood bag processing device according to the third embodiment may also include a barcode scanner 36 and a label printer 38. Of course, the barcode scanner 36 and the label printer 38 can be used in combination with the blood bag processing device 1 according to the first embodiment.

[0057] List of reference signs

[0058] 1 Blood Bag Processing Unit

[0059] 2 Blood Bag Transfer Unit

[0060] 4 Blood Component Bag Transfer Unit

[0061] 6 sterile docking block

[0062] 8 centrifuge receiver

[0063] 10 box

[0064] 12 docking element

[0065] 14 working element

[0066] 16 first button

[0067] 18 second button

[0068] 20 table

[0069] 22 table top

[0070] 24 table base

[0071] 26th video

[0072] 28 working hole

[0073] 30 protruding surface

[0074] 32 chair

[0075] 34 Blood Component Bag Retaining Element

[0076] 36 barcode scanner

[0077] 38 Label Printer

[0078] 40 monitor

[0079] 42 shelf space

[0080] 44 Empty centrifuge receiver

[0081] 46 side table

[0082] 48 top shelf

[0083] 50 Bottom Shelf

[0084] 52 roller

[0085] 54 centrifuge receiver

[0086] 56 empty centrifuge receiver

[0087] 58 Blood Bag Processing System

[0088] 60 Blood Separation Centrifuge

[0089] 62 Blood Component Bag Transfer Unit

[0090] 64 Blood Component Bag Transfer Unit.

Claims

1. A blood bag processing device built into a table and comprising: a blood bag handling unit configured to handle blood bags arranged in a predetermined order, filled with separated blood components and containing a single blood bag tube that is hermetically sealed or connected to a blood collection needle; a blood component bag moving unit configured to move individual blood component bags connected to a single blood component bag tube and / or connected via a Y-shaped connector to a single blood component bag tube in accordance with a predetermined order of the blood bags; a sterile docking unit capable of sterilely connecting the tubes of individual blood bags to the single tubes of blood component bags, and a docking element located on the upper surface of the table between the blood bag transport unit and the blood component bag transport unit, and a working element located under the upper surface of the table with the possibility of accessing it through a working opening made in the side surface of the table.

2. The device according to paragraph 1, wherein the table is height-adjustable.

3. The device according to claim 1, wherein the table is mounted on rollers.

4. A device according to any one of paragraphs 1-3, in which the blood bag transfer unit is designed to accommodate centrifuge receivers with stored blood bags.

5. The device according to claim 4, wherein the blood bag transport unit is a conveyor belt.

6. A device according to any one of paragraphs 1-5, in which the unit for moving blood bags is designed with the possibility of accommodating a container in the form of an envelope for storing bags for blood components.

7. The device according to claim 6, in which the unit for moving bags for blood components contains slots or grooves designed to receive the container in a vertical position.

8. A device according to any one of paragraphs 2-7, in which the blood bag transfer unit and / or the blood component bag transfer unit are recessed relative to the upper surface of the table.

9. The device of any one of claims 1 to 8, wherein the sterile docking unit comprises a blood bag or blood component bag retaining element.

10. The device according to claim 9, wherein the working element is designed to be activated by simultaneous touching with both hands.

11. The device according to any one of paragraphs. 1-10, in which the sterile docking unit is configured to sterilely dock the blood bag tube and the blood component bag tube using radiofrequency heating.

12. A device according to any one of paragraphs 1-11, in which the table is shaped to be positioned near the centrifuge.

13. The device according to any one of paragraphs 1-12, further comprising a unit for receiving identification information of blood bags.

14. The device according to claim 13, further comprising a printing device for printing labels with identification information placed on the blood component bag.

15. The device according to claim 14, wherein the unit for moving the blood component bags is configured to move the blood component bags in accordance with the identification information.

16. The device according to any one of paragraphs 13-15, further comprising a monitor for displaying identification information and the type of blood component bag.

17. A blood bag processing system comprising: a blood separation centrifuge capable of separating whole blood collected in blood bags into blood components; a blood bag processing device according to any one of paragraphs 1-16; and A device for squeezing blood components from blood bags after centrifugation into blood component bags.

18. A method for processing blood bags, which includes: using a blood bag processing device according to any one of paragraphs 1-16; moving blood bags that are filled with separated blood components and contain a single tube of blood bags that is sealed or connected to a blood collection needle in a predetermined order; moving the blood component bags connected to the single blood component bag tube or connected through a Y-shaped connector to the single blood component bag tube in accordance with a predetermined order of the blood bags; and sterile connection of the tubes of blood bags with the tubes of blood component bags.

Citation Information

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