Bag set with fluid diverting cassette and apparatus for preparing suspensions in the bag set into different components

Abstract

The bag set with fluid diversion box and the equipment for preparing blood in the bag set into different component blood, the bag set includes fluid diversion box, bag body, transfer tube, the outflow interface, mixing interface and inflow interface of the fluid diversion box are respectively communicated with at least one bag body through the transfer tube, which is used for collecting blood, centrifugal separation, and preserving component blood; the outflow interface and the inflow interface are respectively communicated with one bag body through the transfer tube, and the mixing interface is connected with the transfer tube, which is used for preparing and preserving washed red blood cells. The equipment for preparing blood in the bag set into different component blood can complete centrifugal separation of blood, component blood collection, addition of red blood cell preserving solution, heat sealing of the transfer tube, and automatically prepare component blood from whole blood, and can also automatically complete preparation of washed red blood cells, thereby improving the convenience of component blood preparation.

Description

Technical Field

[0001] This invention relates to medical devices, specifically to a bag assembly with a fluid reversing box and an apparatus for preparing a suspension within the bag assembly into different components. Background Technology

[0002] Blood transfusion is used in clinical treatment, and there are two main methods of transfusion: whole blood transfusion and component blood transfusion. In order to conserve blood resources, reduce the input of unnecessary blood components, and reduce the risks of transfusion therapy, clinical treatment mainly uses component blood transfusion, such as leukocyte-reduced red blood cells, concentrated platelets, and fresh frozen plasma.

[0003] The preparation of blood components mainly includes: manual or semi-automatic preparation of ex vivo blood, where the collected whole blood is centrifuged using a large-capacity centrifuge and then manually prepared using a separator or semi-automatically prepared using an automatic squeezing device; and single-component blood collection using a cell separator, where the cell separator extracts whole blood from the donor, and while the whole blood is circulated in vitro, it is centrifuged to separate the components, selectively and automatically identifying and collecting the stratified blood components.

[0004] Manual or semi-automatic preparation of blood components suffers from drawbacks such as low separation efficiency, high labor intensity, cumbersome operation procedures, high skill requirements for operators, variations in blood quality depending on the operator, and the need for secondary centrifugation to ensure the quality of the blood components. Currently, the preparation of blood components from ex vivo blood mainly involves converting whole blood into plasma and red blood cells, with less focus on the preparation of concentrated platelets, resulting in a waste of platelet components in the blood.

[0005] Cell separators can collect blood components, producing stable quality blood components that are easy to operate and require less labor. However, they also have drawbacks, such as the large volume of blood requiring extracorporeal circulation from donors, long separation and preparation times, high health requirements for component donors, difficulty in recruiting component donors, and expensive disposable consumables.

[0006] The applicant's previous patent application, 202011244334.5, described blood bags and equipment for blood collection, separation, transfer, storage, and transfusion. However, these devices have drawbacks, such as the need to manually add red blood cell preservation solution after the blood components are removed from the device, manually heat-sealing the transfer tubes between blood bags, and the inability to automatically wash blood cells.

[0007] The above discussion addresses the specific problem of preparing blood into component blood. The application of this invention is not limited to the separation of blood components, but can also be extended to other forms of suspension preparation into two or more components. Summary of the Invention

[0008] The purpose of this invention is to provide a bag assembly with a fluid reversing box and an apparatus for preparing the suspension within the bag assembly into different components. The bags in the bag assembly are made of a flexible material, and the suspension can be a cell-containing suspension, such as whole blood or a cell-containing liquid.

[0009] Compared with the series blood bags and separation device with separation chamber described in patent application 202011244334.5, this invention further improves and enriches the technical content. The present invention uses a bag assembly with a fluid reversing box and a device for preparing blood from the bag assembly into different components, thus solving the defects in patent application 202011244334.5. It achieves automatic addition of red blood cell additives and a heat-sealing function for the transfer tube between blood bags, and also enables automatic preparation of washed red blood cells.

[0010] The technical solution of the present invention is as follows: A bag assembly with a fluid reversing box, the bag assembly including a fluid reversing box, a bag body, and a transfer tube. The fluid reversing box is a plug-type fluid reversing box composed of a box body and a valve core. The box body is provided with a plug cavity and an outflow port, a mixing port, and an inflow port respectively connected to the plug cavity. The plug cavity is an open cavity, and a valve core is installed in the plug cavity. The valve core is connected to a valve core handle, one end of which is exposed outside the plug cavity and has a locking structure. A guide channel is provided on the valve core, and the valve core and the plug cavity can rotate relative to each other. When the valve core is in the stationary position, the outflow port, the mixing port, and the inflow port are mutually closed and connected. When the valve core rotates in the plug cavity, the mixing port and the outflow port are connected through the guide channel, while the inflow port is kept closed from being connected to the outflow port and the mixing port. Alternatively, when the valve core rotates in the plug cavity, the mixing port and the inflow port are connected through the guide channel, while the outflow port and the inflow port and the mixing port are kept closed.

[0011] The fluid reversing box has an outflow port, a mixing port, and an inflow port each connected to at least one bag via a transfer tube. This connection is used for blood collection, separation and transfer, addition, storage, and infusion of preservation solution. For example, the outflow port is connected to a plasma bag via a transfer tube, the mixing port to a blood collection bag via a transfer tube, and the inflow port to a preservation solution bag via a transfer tube. Alternatively, the fluid reversing box has an outflow port and an inflow port each connected to at least one bag via a transfer tube. The mixing port is a closed transfer tube, which is used for aseptic connection to a washed blood bag containing cellular components, completing the automated washing and preparation of cellular components.

[0012] Furthermore, the fluid reversing box body is also provided with a detection chamber and / or a separation chamber. The detection chamber is located between the mixing interface and the stopcock chamber or between the stopcock chamber and the outflow interface, and the separation chamber is located between the outflow interface and the stopcock chamber.

[0013] The placement of the detection cavity depends on the location of the photodetector on the device used to prepare different components from a suspension in a bag assembly with a fluid reversing box. Different photodetector placements result in different detection locations. When the photodetectors are installed on both sides of the hot melt bath, they detect the liquid in the transfer tube connected to the mixing interface, and a detection cavity is not needed on the fluid reversing box. When the first photodetector is located in the recess or on the top cover of the device, the detection location is where the detection cavity is located, therefore a detection cavity is required on the fluid reversing box.

[0014] Depending on whether or not a separation chamber is required to prepare blood components without leukocytes, the separation chamber may or may not be provided on the fluid diversion box. For example, when leukocytes are first removed by filtration and then centrifugation is used to prepare blood components, a separation chamber may not be provided on the fluid diversion box.

[0015] When a separation chamber is provided on the plug-type fluid diverter box, the separation chamber is either a funnel-shaped separation chamber or a pipe-shaped separation chamber. A funnel-shaped separation chamber is a cavity shaped like a funnel, while a pipe-shaped separation chamber is a cavity shaped like a curved, coiled pipe.

[0016] When a funnel-shaped separation chamber is provided on the stopcock-type fluid diverter box, the front opening of the funnel-shaped cavity is connected to the detection chamber or the stopcock chamber, and the rear opening of the funnel-shaped cavity is connected to the outflow interface. The inner wall of the funnel-shaped separation chamber can also be stepped or conical, or it can be a cavity of other shapes with a gradually increasing cross-sectional area from the front opening to the rear opening. When a pipe-type separation chamber is provided on the fluid diverter box, one end of the pipe-type separation chamber is connected to the outflow interface, and the other end is connected to the stopcock chamber or the detection chamber. The pipe is curved or coiled, and the pipe adopts a spiral, serpentine, or U-shaped shape. The purpose is to increase the residence time of the liquid in the separation chamber under a set centrifugal force, to achieve the effect of stratification within the pipe, so that cells of different specific gravities generally form separate flow areas (e.g., Figure 3d (As shown).

[0017] Considering the complexity and high cost of manufacturing a single pipe shape, the preferred option is a modular structure for the pipe-type separation chamber, comprising a box and a cover. The box has a groove in a coiled shape, and the cover connects to the box to form a closed pipe. Alternatively, grooves with matching positions and shapes can be provided on both the box and the cover, with the cover connecting to the box to form a closed pipe (e.g., ...). Figure 2c , 2d (As shown). One end of the closed pipe is connected to the plug chamber or probe chamber, and the other end of the closed pipe is connected to the outflow interface.

[0018] Furthermore, the fluid reversing box also includes a guide groove and / or a locking point between the plug chamber and the valve core. The guide groove is located at the open portion of the plug chamber, with the valve core stalk exposed within it, allowing for rotatable connection between the plug chamber and the valve core. The guide groove prevents the valve core stalk from protruding from the fluid reversing box surface, facilitating installation. While it can be used without the guide groove, the valve core stalk protrudes from the fluid reversing box surface, making installation less convenient and quick. The locking point between the inner wall of the plug chamber and the valve core body wall can be a connection between a convex ring and a groove, or a connection between a convex ring and a protruding point. The locking does not affect the relative rotation of the valve core and the plug chamber, but it will not dislodge within a certain force range; beyond this force range, the valve core can be pulled out.

[0019] The above describes a plug-type fluid diverter box. Corresponding suspension preparation equipment requires a valve rotation assembly. In order to reduce the number of parts in the suspension preparation equipment, a centrifugal plug-type fluid diverter box that relies solely on centrifugal force to achieve the combination of flow channels can be used.

[0020] A bag assembly with a fluid diversion box, the bag assembly comprising a fluid diversion box, a bag body, and a transfer tube, wherein the fluid diversion box is a centrifugal plug-type fluid diversion box composed of a box body, a first plunger, a second plunger, and a spring; the box body is provided with a first plunger cavity, a second plunger cavity, an outflow port, a mixing port, and an inflow port; the first plunger cavity is connected to the mixing port, the outflow port, and the second plunger cavity respectively, and the other end of the second plunger cavity is connected to the inflow port; a spring and a first plunger are installed in the first plunger cavity, and a second plunger is installed in the second plunger cavity; when the first plunger is in the stationary position, the connection between the first plunger cavity and the outflow port is closed, and when the second plunger is in the stationary position, the connection is closed. The connection between the first plunger cavity and the second plunger cavity is closed. Under the set centrifugal force, the first plunger compression spring moves within the first plunger cavity, connecting the first plunger cavity to the outlet port. The second plunger moves within the second plunger cavity, connecting the first and second plunger cavities and closing the connection between the inlet port and the second plunger cavity, allowing fluid to enter the outlet port from the mixing port but not the inlet port. After the set centrifugal force is removed, the spring pushes the first plunger to move within the first plunger cavity, closing the connection between the first plunger cavity and the outlet port, and connecting the inlet port to the second plunger cavity, allowing fluid to enter the mixing port from the inlet port but not the outlet port.

[0021] The fluid reversing box has at least one bag connected to its outflow, mixing, and inflow ports via transfer tubes for blood collection, separation, transfer, storage, and infusion. For example, the outflow port is connected to a plasma bag via a transfer tube, the mixing port is connected to a blood collection bag via a transfer tube, and the inflow port is connected to a preservation solution bag via a transfer tube. Alternatively, the fluid reversing box has at least one bag connected to its outflow and inflow ports via transfer tubes, and the mixing port is a closed transfer tube for washing blood containing cellular components.

[0022] Similarly, like the plug-type fluid diverter box, the centrifugal plug-type fluid diverter box body is also provided with a detection chamber and / or a separation chamber. The detection chamber may or may not be provided depending on the installation position of the photodetector, and the separation chamber may or may not be provided depending on the different blood components to be prepared.

[0023] The detection chamber is located between the mixing interface and the first plunger chamber or between the first plunger chamber and the outflow interface, and the separation chamber is located between the outflow interface and the first plunger chamber.

[0024] When a separation chamber is provided on the centrifugal plug-type fluid reversing box, the separation chamber is either a funnel-shaped separation chamber or a pipe-shaped separation chamber. The funnel-shaped separation chamber is a cavity shaped like a funnel, with the front opening of the funnel-shaped cavity communicating with the detection chamber or the first plunger cavity, and the rear opening of the funnel-shaped cavity communicating with the outflow interface; the pipe-shaped separation chamber is a cavity shaped like a curved, coiled pipe, with one end of the pipe-shaped separation chamber (which has the same shape and function as the plug-type fluid reversing box) communicating with the outflow interface, and the other end communicating with the first plunger cavity or the detection chamber.

[0025] Similarly, the pipe-type fluid diverter box and the centrifugal plug fluid diverter box are designed as a split-type combined structure, with one end of the closed pipe connected to the first plunger cavity or the detection cavity, and the other end of the closed pipe connected to the outflow interface.

[0026] An apparatus for preparing suspensions in a bag assembly with a fluid reversing box into different components is disclosed. A centrifugal motor drives a separating rotor to rotate via a centrifugal shaft. The separating rotor is equipped with a lifting mechanism and has an open-top separating chamber and a hot-melt chamber. The separating chamber is an open-top cavity used to load the bag assembly box. A hot-melt chamber cover is installed on the hot-melt chamber, and the hot-melt chamber cover has a cavity corresponding to the separating chamber. The cavity is used to load the fluid reversing box. A hot-melt groove is provided between the side wall of the separating chamber and the cavity of the hot-melt chamber cover. Hot-melt components for hot-melting and sealing the transfer tube inside the hot-melt groove are installed on both sides of the hot-melt groove and inside the hot-melt chamber.

[0027] The hot-melt assembly includes: a hot-melt moving head, a hot-melt stationary head, a moving head driver, a radio frequency generator, and a spring. The hot-melt moving head consists of a fork-shaped hot-melt head and a hot-melt connecting part. The hot-melt connecting part is connected to the drive shaft of the moving head driver. The hot-melt head and the hot-melt stationary head are mounted opposite each other on both sides of the hot-melt groove. The hot-melt head or the hot-melt stationary head of the hot-melt moving head is connected to the radio frequency generator, which provides radio frequency energy for the hot-melt sealing of the transfer tube. The moving head driver drives the hot-melt moving head to move. A spring is installed on the drive shaft, which is adapted to maintain the pressure of the hot-melt moving head on the transfer tube when the transfer tube is hot-melt sealed. A vertical semi-cylindrical or trapezoidal column is provided on the opposite surface of the hot-melt head and the hot-melt stationary head to facilitate manual disconnection after the transfer tube is sealed by hot-melt.

[0028] The bag assembly box is used to load the bags on the bag assembly with the fluid reversing box. It includes a box body and a bottom cover. The box body has an open membrane cup cavity at the top. The inner wall of the membrane cup cavity is covered with a flexible membrane. The flexible membrane and the membrane cup cavity wall are not completely connected to form a sealed expansion and contraction space, or the flexible membrane and the membrane cup cavity are not completely connected to form a non-sealed space and an airbag is installed. The bottom cover includes a bottom cover frame and a bag body pad. The bag body pad is flexible and its edge is fixed to the bottom cover frame. The bottom cover frame is movably connected to the box body. An openable and closable compression cavity is formed between the box body and the bottom cover.

[0029] It also includes an air pump. The air pump is installed on the bag assembly box, and the air pump inflation port is connected to the sealed expansion and contraction space or airbag between the flexible membrane and the membrane cup cavity. The bag assembly box is also provided with a pressure relief valve that is connected to the sealed expansion and contraction space or airbag between the flexible membrane and the membrane cup cavity. Alternatively, the air pump may be installed on the separating rotor, and the inner wall of the separating chamber may be provided with an air nozzle that communicates with the air pump's inflation port. The bag assembly box body may be provided with air holes, which connect the sealed space or air bladder between the flexible membrane and the membrane cup cavity to the outside of the box body. After the bag assembly box is loaded into the separating chamber, the air holes and air nozzles are sealed and connected.

[0030] The lifting mechanism is installed inside the separating rotor and close to the centrifugal shaft. The mounting cavity of the lifting mechanism is connected to the separating chamber. When the lifting end face of the lifting mechanism is raised, it is higher than the inner wall of the separating chamber and passes through the bottom cover frame to generate extrusion force on the fluid in the bag of the bag group box extrusion chamber.

[0031] A control unit is electrically connected to the hot melt assembly, air pump, and lifting mechanism, and the control unit controls the status of the hot melt assembly, air pump, and lifting mechanism.

[0032] The bag set box also includes a top cover and / or a cup cavity on the box body; the top cover and the box body are movably connected to form an openable collection cavity, the concave cavity of the collection cavity box body is provided with a body protrusion, and the concave cavity of the top cover of the collection cavity is provided with a cover protrusion; the cup cavity is an open cavity at the top of the box body.

[0033] The equipment is also equipped with multiple photoelectric detectors. The first photoelectric detector is located in a recessed cavity, or in a hot melt tank that at least accommodates the transfer tube connected to the mixing interface, or in the top cover of the equipment; the second photoelectric detector is located in a recessed cavity or in the top cover of the equipment. When the photoelectric detectors are located in the top cover of the equipment, as the separator rotor rotates, the first photoelectric detector periodically detects the presence of liquid or component concentration in the fluid reversing box detection cavity or the transfer tube connected to the mixing interface in multiple recessed cavities. The second photoelectric detector periodically detects the color markings, QR codes, or barcodes on the fluid reversing boxes. When the photoelectric detectors are located in the recessed cavity of the hot melt chamber cover or in the hot melt tank, the first photoelectric detector only detects the presence of liquid or component concentration in the detection cavity of a single fluid reversing box or the transfer tube connected to the mixing interface, and the second photoelectric detector only detects the color markings, QR codes, or barcodes on a single fluid reversing box.

[0034] When the bag assembly used is a plug-type fluid reversing box, the separation rotor hot melt chamber is also equipped with a valve rotation assembly (the centrifugal plug-type fluid reversing box does not have a valve rotation assembly), including a valve rotation motor and a plug shaft. The end of the plug shaft is exposed in the cavity. After the plug-type fluid reversing box with valve core is installed in the cavity, the plug shaft is matched and engaged with the locking structure on the valve core handle. The rotation motor drives the valve core to rotate via the plug shaft.

[0035] The beneficial effects of this invention are as follows: The bag assembly with a fluid reversing box of this invention is used for blood collection. When used in conjunction with the device of this invention for preparing blood into different components from the blood in the bag assembly, the blood in the bag assembly undergoes centrifugation separation, component blood collection, addition of red blood cell preservation solution, and heat-sealing of the transfer tube in a single operation, automatically preparing whole blood into component blood. It can also be used for aseptic connection to blood bags containing cellular components, performing cell washing and heat-sealing of the transfer tube, automatically completing the preparation of washed cells. This invention achieves "one-click" completion of component blood or washed cell preparation and heat-sealing of the transfer tube.

[0036] This invention can further improve the convenience of component blood preparation, improve the quality of component blood, save component blood preparation time, reduce the labor intensity of staff, improve the comprehensive utilization rate of blood and save blood resources. Attached Figure Description

[0037] Figure 1 This is a schematic diagram of a bag assembly method with a fluid reversing box according to the present invention; Figure 2a This is a schematic cross-sectional view of the funnel-shaped separation chamber of the plug-type fluid reversing box of the present invention. Figure 2b This is a cross-sectional schematic diagram of the separator chamber of the plug-type fluid reversing box of the present invention being of the pipe type; Figure 2c This is a longitudinal sectional view of the fluid reversing box separation chamber of the present invention, which is a spiral pipe type; Figure 2d This is a longitudinal sectional view of the fluid reversing box separation chamber of the present invention, which is a U-shaped pipe. Figure 2e This is an isometric view of the rotary fluid reversing box of the present invention; Figure 3a This is a schematic cross-sectional view of the centrifugal plug-type fluid reversing box separation chamber of the present invention, which is funnel-shaped. Figure 3b This is a cross-sectional schematic diagram of the centrifugal plug-type fluid reversing box separation chamber of the present invention, which is of the pipe type. Figure 3c This is an isometric view of the centrifugal plug-type fluid reversing box of the present invention; Figure 3dThis is a schematic diagram of the fluid reversing box pipe-type separation chamber of the present invention, showing that the components of different weight ratios are generally stratified. Figure 4 This is a schematic diagram of the bag assembly box of the present invention in the open state; Figure 5 This is a cross-sectional schematic diagram of the bag assembly box of the present invention; Figure 6 This is a partial sectional view of the separated rotor of the present invention, which is an isometric view. Figure 7 It is an isometric view of the bag assembly containing the bag assembly with the fluid reversing box after it is installed into the separator rotor; Figure 8 This is a cross-sectional view of a bag assembly containing a fluid reversing box after it has been installed into a centrifugal separator. Figure 9 This is a partial cross-sectional view of the bag assembly containing the fluid reversing box after it has been inserted into the separator rotor. Detailed Implementation

[0038] This invention describes a specific suspension separation, namely, a bag assembly with a fluid reversing box for the collection and separation of blood, separating whole blood into plasma and erythrocyte components, or separating it into plasma, platelets, and erythrocyte components. This specific application is exemplary.

[0039] Figure 1 This is a schematic diagram of one assembly of the bag assembly 1 with a fluid reversing box according to the present invention. This bag assembly is suitable for collecting blood and separating whole blood into plasma, concentrated platelets, and suspended red blood cells in a single step, and then preparing the suspended red blood cells into leukocyte-reduced suspended red blood cells.

[0040] The connection method of this bag assembly is as follows: the fluid switching box 2 has three ports. The outflow port 22 is connected to the first transfer tube 3. The other end of the first transfer tube 3 is connected to the second component bag 8. The second component bag 8 is connected to the first component bag 6 via the second transfer tube 4. The mixing port 25 of the fluid switching box 2 is connected to the fourth transfer tube 19. The other end of the fourth transfer tube 19 is connected to the cell bag 11. The cell bag 11 is connected to the third transfer tube 9 and the easy-break plug 12. The other end of the third transfer tube 9 is connected to the needle 10 and the needle cap. It is connected to the fifth transfer tube 14 via the easy-break plug 12. The fifth transfer tube 14 is connected in series with the white blood cell filter 18 and then connected to the transfer bag 15. The inflow port 27 of the fluid switching box 2 is connected to the sixth transfer tube 17. The other end of the sixth transfer tube 17 is connected to the liquid bag 16.

[0041] The component bag 6 is used to collect plasma, which is ultimately used for plasma storage. The bag is generally a rectangular flat bag. The top of the bag has a fixing hole for positioning and fixing the bag, and connects to the transfusion port 5 and the first transfer tube 4.

[0042] Component bag 2, 8, is used to collect platelets and ultimately store concentrated platelets. The bag is generally rectangular with a rounded or trapezoidal top, and has a fixing hole 7 at the top for positioning and securing the bag, connecting to the transfusion port 5, the first transfer tube 3, and the second transfer tube 4. Preferably, the first transfer tube 3 and the second transfer tube 4 are symmetrically connected on both sides of the top center of component bag 2, 8.

[0043] Cell bag 11 is used to collect or receive blood. The bag is generally rectangular with a rounded or trapezoidal top, and has a fixing hole 7 on the top edge for positioning and fixing. When collecting blood, the bag contains a blood preservation solution for a predetermined amount of blood (e.g., 400 mL). The top of the bag is connected to a transfusion port 5, a foldable stopper 12, a catheter 13 for infusing the preservation solution, a third transfer tube 9, a fourth transfer tube 19, and a fifth transfer tube 14. The other end of the transfer tube 9 is connected to a needle 10 and a needle cap. The fifth transfer tube 14 is connected to the foldable stopper 12. Preferably, the fourth transfer tube 19 is located in the center of the rounded or trapezoidal top of the bag.

[0044] Leukocyte filter 18 is used to retain leukocytes in the blood flowing through leukocyte filter 18.

[0045] The transfer bag 15 is used to collect leukocyte-reduced blood. It is a roughly rectangular flat bag with a transfusion port 5 and a fifth transfer tube 14 connected to the top.

[0046] The liquid bag 16 is a generally rectangular flat bag containing a predetermined amount of red blood cell preservation solution (e.g., 100 mL). The top of the bag is connected to a sixth transfer tube 17 and a conduit 10 for perfusing the red blood cell preservation solution.

[0047] Depending on the need to prepare different blood components, the fluid switching box 2 of the bag assembly 1 with fluid switching box of the present invention can be selectively connected with bags and white blood cell filters 18 with different functions to form bag assemblies 1 with fluid switching boxes in different combinations.

[0048] The following examples illustrate several other combinations of the bag assembly 1 with fluid reversing box according to the present invention: Suitable for blood collection, first filtering removes white blood cells from whole blood, then separating the white blood cells-free blood into bags of plasma, concentrated platelets, and white blood cell-free suspended red blood cells in one step. The connection method for these bags is as follows: the first transfer tube 3 is connected to the outflow port 22 of the fluid switching box 2; the other end of the first transfer tube 3 is connected to component bag two 8; component bag two 8 is connected to component bag one 6 via the second transfer tube 4; the fourth transfer tube 19 is connected to the mixing port 25 of the fluid switching box 2; the other end of the fourth transfer tube 19 is connected to transfer bag 15; the top of transfer bag 15 is connected to the fifth transfer tube 14; the fifth transfer tube 14 is connected in series... After connecting to the leukocyte filter 18 (which filters out only leukocytes and not platelets), connect to the cell bag 11. The cell bag 11 is connected to the fifth transfer tube 14 with an easy-break plug 12. The top of the cell bag 11 is connected to the third transfer tube 9. The other end of the third transfer tube 9 is connected to the needle 10 and the needle cap. The cell bag 11 contains a blood preservation solution containing a predetermined amount of blood (e.g., 400 mL). The fluid diversion box 2 is connected to the inlet 27 of the sixth transfer tube 17. The other end of the sixth transfer tube 17 is connected to the liquid bag 16. The liquid bag 16 contains a predetermined amount of red blood cell preservation solution (e.g., 100 mL).

[0049] A bag assembly with a fluid reversing box is suitable for collecting blood and separating the collected whole blood into plasma, concentrated platelets, and leukocyte-reduced suspended red blood cells in a single operation. The connection method of this bag assembly is as follows: the first transfer tube 3 is connected to the outflow port 22 of the fluid reversing box 2, and the other end of the first transfer tube 3 is connected to the second component bag 8. The second component bag 8 is connected to the first component bag 6 via the second transfer tube 4. The fourth transfer tube 19 is connected to the mixing port 25 of the fluid reversing box 2, and the other end of the fourth transfer tube 19 is connected to the cell bag 11. The third transfer tube 9 is connected to the cell bag 11, and the other end of the third transfer tube 9 is connected to the needle 10 and needle cap. The cell bag 11 contains a blood preservation solution containing a predetermined amount of blood (e.g., 400 mL). The sixth transfer tube 17 is connected to the inflow port 27 of the fluid reversing box 2, and the other end of the sixth transfer tube 17 is connected to the liquid bag 16, which contains a predetermined amount of red blood cell preservation solution (e.g., 100 mL).

[0050] This is a bag assembly with a fluid reversing box suitable for collecting blood and filtering whole blood to remove white blood cells, then separating the white blood cells-free blood into plasma and white blood cell-free suspended red blood cells in a single step. The connection method of this bag assembly is as follows: the first transfer tube 3 is connected to the outflow port 22 of the fluid reversing box 2, and the other end of the first transfer tube 3 is connected to the component bag 6; the fourth transfer tube 19 is connected to the mixing port 25 of the fluid reversing box 2, the other end of the fourth transfer tube 19 is connected to the transfer bag 15, and the top of the transfer bag 15 is connected to the fifth transfer tube 14, which is connected in series... After connecting the white blood cell filter 18, connect the cell bag 11. The cell bag 11 is connected to the fifth transfer tube 14 with an easy-break plug 12. The top of the cell bag 11 is connected to the third transfer tube 9. The other end of the third transfer tube 9 is connected to the needle 10 and the needle cap. The cell bag 11 contains blood preservation solution pre-collected with a predetermined amount of blood (e.g., 400 mL). The fluid diversion box 2 inlet 27 is connected to the sixth transfer tube 17. The other end of the sixth transfer tube 17 is connected to the liquid bag 16. The liquid bag 16 contains a predetermined amount of red blood cell preservation solution (e.g., 100 mL).

[0051] A bag assembly with a fluid reversing box is suitable for collecting blood and converting collected whole blood into plasma and leukocyte-reduced red blood cell suspensions. The connection method of this bag assembly is as follows: the first transfer tube 3 is connected to the outflow port 22 of the fluid reversing box 2, and the other end of the first transfer tube 3 is connected to the component bag 6; the fourth transfer tube 19 is connected to the mixing port 25 of the fluid reversing box 2, and the other end of the fourth transfer tube 19 is connected to the cell bag 11, the third transfer tube 9 is connected to the cell bag 11, and the other end of the third transfer tube 9 is connected to the needle 10 and the needle cap. The cell bag 11 contains a blood preservation solution containing a predetermined amount of blood (e.g., 400 mL); the sixth transfer tube 17 is connected to the inflow port 27 of the fluid reversing box 2, and the other end of the sixth transfer tube 17 is connected to the liquid bag 16, which contains a predetermined amount of red blood cell preservation solution (e.g., 100 mL).

[0052] The above-described examples illustrate several embodiments of the present invention with fluid switching boxes suitable for collecting blood and separating the collected whole blood into blood bags of different components: Optionally, the transfer tube 9 downstream of the needle 10 is connected to the sample retention device via a branch tube and a clamp is installed.

[0053] Optionally, the cell bag 11 or transfer bag 15 is provided with a foldable plug, one end of the fourth transfer tube 19 is connected to the foldable plug on the cell bag 11 or transfer bag 15, and the other end of the fourth transfer tube 19 is connected to the mixing port 25 of the fluid reversing box 2; the top of the liquid bag 16 is provided with a foldable plug, one end of the sixth transfer tube 17 is connected to the foldable plug on the liquid bag 16, and the other end of the sixth transfer tube 17 is connected to the inflow port 27 of the fluid reversing box 2.

[0054] Optionally, a transfer tube can be connected in parallel to the fifth transfer tube 14 at both ends of the white blood cell filter 18 and clamps can be installed.

[0055] A bag assembly with a fluid reversing chamber is suitable for washing and preparing washed cells. The bag assembly is connected as follows: a first transfer tube 3 is connected to the outflow port 22 of the fluid reversing chamber 2, and the other end of the first transfer tube 3 is connected to component bag 6; a fourth transfer tube 19 with a closed port is connected to the mixing port 25 of the fluid reversing chamber 2, and the closed port of the fourth transfer tube 19 is used for aseptic connection to the bag containing the cells to be washed; a sixth transfer tube 17 is connected to the inflow port 27 of the fluid reversing chamber 2, and the other end of the sixth transfer tube 17 is connected to a liquid bag 16 containing a predetermined amount of cell washing solution (e.g., 400 mL of physiological saline). Component bag 6 serves as a waste bag to collect the discarded cell washing solution after washing.

[0056] The above examples illustrate several commonly used combinations. As needed, the present invention may also have other combinations of different bags and other components connected via the fluid reversing box 2, which will not be listed further.

[0057] Figure 2a , 2b 2c, 2d, and 2e are schematic diagrams of the fluid switching box 2 of the present invention, which is a plug-type fluid switching box.

[0058] The plug-type fluid diverter box 2 consists of a box body and a valve core 24. The box body has at least a plug cavity 23, an outlet port 22, a mixing port 25, and an inlet port 27. The plug cavity 23 is a cavity that is closed at one end and open at the other. The outlet port 22, the mixing port 25, and the inlet port 27 are respectively connected to the plug cavity 23. The valve core 24 is installed inside the plug cavity 23. The valve core 24 has a guide channel 26. The valve core 24 can rotate inside the plug cavity, which can seal the flow and change the direction of liquid flow after rotation.

[0059] In the initial state of the stopcock chamber, the valve core 24 prevents any connection between the outflow port 22, the mixing port 25, and the inflow port 27. When the valve core 24 rotates a certain angle (e.g., 90°), the guide channel 26 connects the mixing port 25 to the outflow port 22 while continuing to prevent connection between the mixing port 25 and the inflow port 27, and between the outflow port 22 and the inflow port 27. When the valve core 24 rotates again by a certain angle (e.g., 90°), the guide channel 26 connects the mixing port 25 to the inflow port 27 while preventing connection between the mixing port 25 and the outflow port 22, and between the outflow port 22 and the inflow port 27. Figure 2aThe guide channel 26 connects the mixing port 25 and the outlet port 22, and prevents the mixing port 25 from connecting with the inlet port 27, and the outlet port 22 from connecting with the inlet port 27. A valve core shank 30 is connected to the valve core 24. The valve core shank 30 is a wedge-shaped or notched locking structure, preferably a wedge-shaped end, exposed outside the stopcock cavity. The valve core 24 is inserted into the stopcock cavity 23 and engaged. Specifically, the engagement structure can be: a concave groove is provided on the inner wall of the stopcock cavity, and a convex ring is provided on the wall of the valve core 24. When the concave groove in the stopcock cavity matches and aligns with the convex ring on the valve core 24, the stopcock cavity 23 is connected to the valve core 24; alternatively, the convex ring and convex point can be engaged. The connection is a snap-fit; the valve core 24 is engaged within the stopcock cavity 23, but this does not affect the rotation of the valve core 24. Only when the applied force exceeds the design range can the valve core 24 be pulled out.

[0060] Preferably, the plug cavity 23 and the valve core 24 are correspondingly fitted cylindrical or correspondingly fitted spherical shapes. For better sealing, a sealing gasket can also be added between the plug cavity 23 and the valve core 24.

[0061] Preferably, a detection cavity 21 is further provided between the outflow port 22 of the fluid diversion box 2 and the stopcock cavity 23. One end of the detection cavity 21 is connected to the stopcock cavity 23 and the other end is connected to the outflow port 22. The inner diameter of the detection cavity 21 is square or rectangular and is made of a transparent material suitable for the light of the first photodetector 60 on the centrifugal separation device to pass through. The detection cavity 21 can also be provided between the mixing port 25 and the stopcock cavity 23, with one end of the detection cavity 21 connected to the stopcock cavity 23 and the other end connected to the mixing port 25.

[0062] Preferably, the fluid reversing box 2 is provided with a guide groove 28. The open valve chamber 23 is located within the guide groove 28, and the valve core handle 30 is exposed in the guide groove 28, such as... Figure 2e As shown.

[0063] Preferably, the fluid diverter box 2 guide groove 28 is covered with a sealing film or sealing cover (not shown in the figure), and the sealing film or sealing cover is a tear-away or easy-to-remove connection, which can be torn or easily removed.

[0064] Preferably, the guide channel 26 on the valve core 24 of the fluid reversing box 2 is a “∟” type with two openings and right angles, or it can be a “T” type with two openings and an included angle of 120°, or it can be a “T” type with three openings and right angles.

[0065] Preferably, the outlet port 22, mixing port 25, and inlet port 27 of the fluid reversing box 2 are located on the same side of the fluid reversing box 2, and the three ports are connected to three openings on the side wall of the stopcock cavity 23 in a "T" shape. The positions of the three ports on the side wall of the stopcock cavity 23 determine the positions of the mixing port 25 and the inlet port 27. Figure 2aIn the diagram, the guide channel 26 is shaped like a "∟". The two openings of the outflow port 22 and the inflow port 27 on the side wall of the stopcock cavity 23 are on a straight line opposite to each other on the left and right sides (as described in the diagram, the same applies below). The inflow port 27 is in the middle of the outflow port 22 and the mixing port 25. If the guide channel 26 is a right-angled "∟" or "T" shaped, the two openings of the outflow port 22 and the inflow port 27 on the side wall of the stopcock cavity 23 are on a straight line opposite to each other on the top and bottom sides. Then the mixing port 25 is in the middle of the outflow port 22 and the inflow port 27. If the guide channel 26 has two openings with an included angle of 120°, then the three ports are connected. The three openings on the side wall of the stopcock cavity 23 have an included angle of 120° with each other. The mixing port 25 is in the middle of the outflow port 22 and the inflow port 27, or the inflow port 27 is in the middle of the outflow port 22 and the mixing port 25.

[0066] Preferably, a separation chamber is provided between the detection chamber 21 of the fluid reversing box 2 and the outflow interface 22 (the detection chamber 21 is located between the outflow interface 22 and the plug chamber 23).

[0067] Optionally, the separation chamber is a funnel-shaped separation chamber 20. Figure 2a This is a cross-sectional schematic diagram of the funnel-shaped separation chamber of the fluid diverter box of the present invention. The separation chamber is a funnel-shaped cavity. The front opening of the funnel-shaped cavity is connected to the detection cavity 21 or the plug cavity 23, and the rear opening of the funnel-shaped cavity is connected to the outflow port 22. The inner wall of the funnel-shaped separation chamber can also be stepped, or it can be a cavity of other shapes with the cross-sectional area gradually increasing from the front opening to the rear opening. After the fluid diverter box 2 is installed in the cavity 58 on the separation rotor 55, the longitudinal axis of the funnel-shaped cavity of the funnel-shaped separation chamber 20 points to the centrifugal shaft 73, and the rear opening of the funnel-shaped cavity is close to the centrifugal shaft 73. Preferably, the front opening of the funnel-shaped separation chamber 20 transitions to the rear opening in a stepped manner.

[0068] Optionally, the separation chamber is a pipe-type separation chamber 29. For example... Figure 2b , Figure 2b This is a cross-sectional view of the separator chamber of the plug-type fluid diverter box of the present invention, which is of the pipe type. The pipe-type separator chamber 29 is a cavity in the shape of a curved and coiled pipe. One end of the pipe-type separator chamber 29 is connected to the outflow interface 22, and the other end is connected to the plug chamber 23 or the detection chamber 21.

[0069] Figure 2c This is a longitudinal sectional view of the fluid reversing box separation chamber of the present invention, which is a spiral pipe type; Figure 2d This is a longitudinal sectional view of the fluid reversing box separation chamber of the present invention, which is a U-shaped pipe. The pipe adopts shapes such as spiral, U-shaped, or serpentine to increase the residence time of the liquid within the separation chamber under a set centrifugal force, achieving stratification within the pipe and allowing components of different proportions to form largely separate flow zones (e.g., ...). Figure 3d (As shown).

[0070] Preferably, the pipe-type separation chamber 29 is a split-type combined structure, including a box body and a cover body. The box body is provided with a groove, which is coiled in shape. The cover body is connected to the box body so that the groove forms a closed pipe; or the box body and the cover body are provided with grooves that match the position and shape. The cover body is connected to the box body so that the grooves of the two are connected to form a closed pipe.

[0071] Optionally, the fluid switching box 2 may be equipped with a color recognition section or a QR code or barcode to identify bag groups 1 with fluid switching boxes that have different connection methods. For example, the fluid switching box 2 recognition section on bag group 1 that collects 400mL of whole blood and separates and prepares plasma, concentrated platelets, and leukocyte-reduced suspended red blood cells is marked in green; the fluid switching box 2 recognition section on bag group 1 that collects 400mL of whole blood and separates and prepares plasma and leukocyte-reduced suspended red blood cells is marked in blue.

[0072] Outflow port 22 is used to connect to the first transfer tube 3, mixing port 25 is used to connect to the fourth transfer tube 19, and inflow port 27 is used to connect to the sixth transfer tube 17.

[0073] Optionally, for the funnel-shaped separation chamber 20, a leukocyte filtration membrane (not shown in the figure) can be installed inside the funnel-shaped separation chamber 20 to further filter leukocytes in the plasma retained in the funnel-shaped separation chamber 20 or in platelet-rich plasma.

[0074] Figure 3a , 3b Figures 3 and 3c are schematic diagrams of the centrifugal plug-type fluid switching box of the present invention.

[0075] The centrifugal plug-type fluid reversing box 2 consists of a box body, a first plunger 33, a second plunger 35, and a spring 32. The box body has a first plunger cavity 31, a second plunger cavity 34, an outlet port 22, a mixing port 25, and an inlet port 27. The first plunger cavity 31 is connected to the mixing port 25, the outlet port 22, and the second plunger cavity 34, respectively. The other end of the second plunger cavity 34 is connected to the inlet port 27. The spring 32 and the first plunger 33 are installed inside the first plunger cavity 31, and the second plunger 35 is installed inside the second plunger cavity 34. When the first plunger 33 is in the stationary position, it closes the connection between the first plunger cavity 31 and the outlet port 22. When the second plunger 35 is in the stationary position, it closes the connection between the first plunger cavity 31 and the second plunger 34. Under constant centrifugal force, the first plunger 33 compresses the spring 32 and moves within the first plunger cavity 31, connecting the first plunger cavity 31 to the outlet port 22. The second plunger 35 moves within the second plunger cavity 34, connecting the first plunger cavity 31 to the second plunger cavity 34 and closing the connection between the inlet port 27 and the second plunger cavity 34, allowing fluid to enter the outlet port 22 from the mixing port 25 but not the inlet port 27. After the set centrifugal force is removed, the spring 32 pushes the first plunger 33 to move within the first plunger cavity 31, closing the connection between the first plunger cavity 31 and the outlet port 22, and connecting the inlet port 27 to the second plunger cavity 34, allowing fluid to enter the mixing port 25 from the inlet port 27 but not the outlet port 22.

[0076] At least one bag is connected to the outflow port 22, mixing port 25, and inflow port 27 of the fluid diversion box 2 via a transfer tube, or at least one bag is connected to the outflow port 22 and inflow port 27 of the fluid diversion box 2 via a transfer tube, and the mixing port 25 is a closed transfer tube.

[0077] Preferably, the first plunger cavity 31 and the second plunger cavity 34 are each composed of a chamber section and a sealing section. The first plunger 33 and the second plunger 35 are each composed of a "T"-shaped head section and a tail section. The head sections of the first plunger 33 and the second plunger 35 are located in the sealing sections of the first plunger cavity 31 and the second plunger cavity 34, respectively, and the tail sections of the first plunger 33 and the second plunger 35 are located in the chamber sections of the first plunger cavity 31 and the second plunger cavity 34, respectively. The first plunger 33 and the second plunger 35 are made of a high-density material wrapped with a flexible material to increase the sealing performance between the head of the first plunger 33 and the second plunger 35 and the sealing section of the first plunger cavity 31 and the second plunger cavity 34. Under a set centrifugal force, the first plunger 33 and the second plunger 35 can easily fall off to the bottom of the chamber section of the first plunger cavity 31 and the second plunger cavity 34. For example, stainless steel wrapped with rubber.

[0078] Preferably, a detection cavity 21 is provided between the mixing interface 25 and the first plunger cavity 31, or between the first plunger cavity 31 and the outflow interface 22. The inner diameter of the detection cavity 21 is square or rectangular and is made of a transparent material suitable for the light of the first photodetector 60 on the centrifugal separation device to pass through.

[0079] Preferably, a separation chamber is provided between the first plunger cavity 31 and the outflow port 22. One end of the separation chamber is connected to the first plunger cavity 31 and the other end is connected to the outflow port 22, or one end of the separation chamber is connected to the detection cavity 21 and the other end is connected to the outflow port 22. The separation chamber can be a funnel-shaped separation chamber 20 or a pipe-shaped separation chamber 29.

[0080] Optionally, the centrifugal plug-type fluid diverter box 2 may be equipped with a color recognition section or a QR code or barcode to identify bag groups 1 with fluid diverter boxes of different connection methods.

[0081] The shape of the centrifugal plug-type fluid reversing box funnel-shaped separation chamber 20 or pipeline-type separation chamber 29 of this invention is similar to... Figure 2a , 2b The separation chambers described in the plug-type fluid reversing box of the present invention are the same as those in 2c and 2d.

[0082] Figure 3a This is a cross-sectional schematic diagram of the centrifugal plug fluid reversing box separation chamber of the present invention, which is funnel-shaped. In the figure, a detection chamber 21 and a funnel-shaped separation chamber 20 are provided between the first plunger cavity 31 and the outflow interface 22.

[0083] Figure 3b This is a cross-sectional schematic diagram of the centrifugal plug-type fluid reversing box separation chamber of the present invention, which is of the pipe type.

[0084] Figure 3d This is a schematic diagram showing the stratified separation of components with different specific gravities in the fluid reversing box pipe-type separation chamber of the present invention. After the fluid reversing box 2 is installed in the cavity 58 on the separation rotor 55, the components with higher specific gravity are farther away from the centrifugal shaft 73.

[0085] Figure 4 , Figure 5 These are schematic diagrams of the "four-cavity double-opening" bag box 40 of the present invention in its open state and cross-sectional views in its closed state.

[0086] The bag assembly box 40 is used to load the bag assembly 1 with the fluid reversing box in the compartment. The "four-chamber double-opening" type bag assembly box 40 mainly includes: top cover 47, box body 42, and bottom cover 41.

[0087] The box body 42 is generally a cuboid with concave sides on both sides. One concave side and bottom edge extend upwards and inwards to form a semi-enclosed box side plate 46. The top surface of the box body 42 has an upwardly open, generally cuboid membrane cup cavity 43 and a box cup cavity 44, wherein: the inner wall of the membrane cup cavity 43 is fitted and covered with a flexible membrane 50, and the flexible membrane 50 is fully enclosed (e.g., Figure 5 As shown) or in a semi-enclosed form (e.g., covering the inner wall of the membrane cup cavity 43 on the side of the cup cavity 44), the upper periphery (fully enclosed form) or periphery (semi-enclosed form) of the flexible membrane 50 is fixedly connected to the wall of the membrane cup cavity 43, and a closed expansion and contraction interlayer is formed between the flexible membrane 50 and the wall of the membrane cup cavity 43. Air is injected into the interlayer, and at least the flexible membrane 50 on the side of the wall of the membrane cup cavity 43 expands into the membrane cup cavity 43.

[0088] The aforementioned method of connecting the flexible membrane 50 to the wall of the membrane cup cavity 43 to form a sandwich requires an airtight connection, such as adhesive bonding. The material of the flexible membrane 50 also needs to be airtight, so the manufacturing cost will be higher. Alternatively, an airbag can be installed between the flexible membrane 50 and the wall of the membrane cup cavity 43. Inflating the airbag causes the flexible membrane 50 to expand into the membrane cup cavity 43. The airbag is prefabricated and can be placed into the sandwich. With this structure, the sandwich between the flexible membrane 50 and the membrane cup cavity 43 does not need to be airtight. As long as the upper perimeter of the flexible membrane 50 can be connected to the membrane cup cavity 43 (such as by using retaining rings), the flexible membrane 50 can also be made of a non-airtight material.

[0089] Optionally, an air pump 75 is installed inside the housing 42. The air pump 75's inflation port is connected to the interlayer space or airbag between the flexible membrane 50 and the membrane cup cavity 43. The housing 42 is also provided with a pressure relief valve that is connected to the sealed expansion and contraction space or airbag between the flexible membrane 50 and the membrane cup cavity 43.

[0090] Optionally, when the air pump 75 is not installed inside the box 42, the box 42 is provided with an air hole 72, which is connected to the interlayer formed between the air hole 72 and the flexible membrane 50 and the membrane cup cavity 43 wall, or the air hole 72 is connected to the air bladder.

[0091] The membrane cup cavity 43 is used to load the liquid bag 16 containing liquid, and the box cup cavity 44 is used to load the component bag 6 or to load the component bag 6, transfer bag 15 and leukocyte filter 18 together.

[0092] The bottom cover 41 consists of a rectangular bottom cover frame and a bag body pad 48. The inner side of the frame opposite to the box body 42 is circularly concave inward. A bag body pad 48 made of a flexible material is fitted and covered inside the concave. The edge of the bag body pad 48 is fixed to the bottom cover frame. The two side edges and the bottom edge of the circular concave of the bottom cover frame extend upward and inward to form a semi-surrounding bottom cover side plate 49. A bottom plate 52 can also be installed at the bottom of the bag body pad 48. The bottom plate 52 has a certain rigidity and is located inside the border or / and the concave of the bottom cover 41. A short post (not shown) for fixing the bag body is provided on the top edge of the circular concave of the bottom cover frame. The bottom cover 41, the bag body pad 48 and the inner concave of the box body 42 together form an extrusion cavity 53. After the bag set box 40 is loaded into the separation chamber 56, the lifting table 81 in the separation rotor 55 can pass through the inner border of the bottom cover 41 and push the bottom plate 52 and the bag body pad 48 to extrude the blood-containing bag body in the extrusion cavity 53.

[0093] The top cover 47 is a cuboid with a slightly concave inner side on one side. The concave on the top cover 47 is arranged opposite to the box body side plate 46 on the box body 42. The concave on the top cover 47 and the concave in the box body 42 form a platelet collection cavity 51. The platelet collection cavity 51 is used to load the component bag two 8; on the concave of the top cover 47 and the concave in the box body 42, there are respectively provided cover convex ribs 54 and body convex ribs 45 that are relatively positioned up and down and conformal. The bottom ends of the cover convex ribs 54 and the body convex ribs 45 are respectively at a certain distance (for example, about 2 cm) from the bottom edge of the concave of the top cover 47 and the box body 42, and the top ends are close to the top edge of the concave (for example, the top ends are about 0.5 cm away from the top edge of the concave). The cover convex ribs 54 and the body convex ribs 45 are not limited to the straight type from the top edge to the bottom edge, and also include other shapes that can divide the concave from the top edge into sub-regions and connect them from the top edge to the bottom edge in the concave of the top cover 47 and the concave in the box body 42, such as the shape of "individual".

[0094] The top cover 47 and the bottom cover 41 are respectively hinged or push-pull connected (not shown) to the box body 42. Rotating or pushing and pulling the top cover 47 opens or closes the platelet collection cavity 51, and rotating or pushing and pulling the bottom cover 41 opens or closes the extrusion cavity 53.

[0095] The shapes and volumes of the membrane cup cavity 43, the box cup cavity 44, the platelet collection cavity 51, and the extrusion cavity 53 are suitable for loading blood bags with different collected blood volumes (for example: 400 mL) and the shapes and volumes of the blood bags for collecting different separated component bloods.

[0096] The usage mode of the "four-chamber double-opening" type bag set box 40 when preparing blood components is as follows: the extrusion cavity 53 is loaded with the cell bag 11 or the transfer bag 15 containing the blood to be separated; the platelet collection cavity 51 is loaded with the component bag two 8 mainly used for collecting platelet components; the membrane cup cavity 43 is loaded with the liquid bag 16 containing the preservative solution; the box cup cavity 44 is used to load the component bag one 6 for collecting plasma or the component bag one 6 for collecting plasma, the empty transfer bag 15 and the leukocyte filter (when needed).

[0097] Depending on the type of bag assembly 1 with fluid reversing box used, the bag assembly box 40 can have different variations: Optionally, the bag assembly 40 is a "three-chamber double-opening" type, mainly including: a top cover 47, a box body 42, and a bottom cover 41. The box body 42 only has a membrane cup cavity 43. The top cover 47 and the box body 42 form a platelet collection cavity 51, and the bottom cover 41 and the box body 42 form a squeezing cavity 53. The bag assembly 40 with the "three-chamber double-opening" structure is suitable for preparing various blood components. In use, the squeezing cavity 53 is loaded with a cell bag 11 or a transfer bag 15 containing blood to be separated, the platelet collection cavity 51 is loaded with a component bag 8, and the membrane cup cavity 43 is loaded with the remaining bags and a leukocyte filter (if needed).

[0098] Optionally, the bag assembly 40 is a "three-chamber single-opening" type, mainly including: a bottom cover 41 and a box body 42. The box body 42 has a cup cavity 44 and a membrane cup cavity 43. The box body 42 and the bottom cover 41 form a squeezing cavity 53. The bag assembly 40 with the "three-chamber single-opening" structure is suitable for preparing blood components that do not collect platelets or preparing washed cells. In use, the squeezing cavity 53 is loaded with a cell bag 11 or transfer bag 15 containing blood to be separated or a blood bag containing cells to be washed. The membrane cup cavity 43 is loaded with a liquid bag 16, and the remaining bags are loaded in the membrane cup cavity 43.

[0099] Optionally, the bag assembly 40 is a "dual-chamber" type, including: a top cover 47 and a box body 42. The box body 42 has only a membrane cup cavity 43. The box body 42 and the bottom cover 41 form a squeezing cavity 53, which constitutes a dual-chamber bag assembly 40. It is mainly suitable for washing cells and preparing blood into plasma and red blood cell components. When used for washing cells, the squeezing cavity 53 contains the blood bag containing the cells to be washed, and the membrane cup cavity 43 contains a liquid bag 16 and a component bag 6 used as a waste liquid bag. When used for preparing plasma and red blood cell components, the squeezing cavity 53 contains a cell bag 11 or a transfer bag 15 containing the blood to be separated, and the membrane cup cavity 43 contains a component bag 6 for collecting plasma or a component bag 6 and a liquid bag 16 containing a preservation solution and a white blood cell filter (if needed).

[0100] Figure 6 This is a side view of the separate rotor 55 of the present invention. Figure 7 This is an isometric view of the bag assembly 1 with fluid reversing box after it has been inserted into the bag assembly box 40 and installed onto the separator rotor 55. Figure 8 This is a cross-sectional view of the centrifugal separation device of the present invention after the bag assembly 1 with the fluid reversing box and the bag assembly box 40 are installed. Figure 9 It is a partial cross-sectional view of the separated rotor 55 after the bag assembly 1 and bag assembly box 40 with fluid reversing box are loaded.

[0101] The device for preparing suspensions in a bag assembly with a fluid reversing box into different components mainly includes: a centrifugal motor 70 and a centrifugal shaft 73 for driving the separation rotor 55 to rotate; a separation rotor 55 fixed to the end of the centrifugal shaft 73; a slip ring 71 for supplying power to the separation rotor 55; a control unit 79 for controlling the coordinated operation of the centrifugal motor 70 and the lifting and squeezing mechanism, valve rotation assembly, hot-melt assembly, air pump 75, and photodetector within the separation rotor 55; and a bag assembly box 40 for loading the bag assemblies. The slip ring 71, the lifting and squeezing mechanism, and the photodetector are described in patent application 202011244334.5, which are incorporated herein by reference.

[0102] The centrifugal motor 70 includes a centrifugal shaft 73, which is fixed to the centrifuge frame by a bearing assembly 78. The separating rotor 55 is fixed to the end of the centrifugal shaft 73, and a slip ring 71 is installed on the centrifugal shaft 73 between the centrifugal motor 70 and the separating rotor 55.

[0103] The upper part of the separating rotor 55 is provided with a separating chamber 56 and a hot melt chamber 69, and a hot melt chamber cover 68 is installed on the hot melt chamber 69.

[0104] Multiple centrifugal separation units are symmetrically arranged at equal intervals around the axis of the centrifugal shaft 73, preferably 4 or 6 centrifugal separation units. Each centrifugal separation unit includes: The separation chamber 56 is a rectangular cavity with an open upper portion used to hold the bag assembly box 40. The separation chamber 56 is at a certain angle (e.g., 20°) to the axis of the centrifugal shaft 73. The shape and size of the separation chamber 56 are basically the same as the shape and size of the bag assembly box 40 in the closed state, allowing the bag assembly box 40 to be easily placed into or removed from the separation chamber 56. Multiple toothed grooves are provided on the side wall of the separation chamber 56 near the centrifugal shaft 73.

[0105] The lifting and squeezing mechanism is used to expel the fluid from the bag body in the squeezing chamber 53. The lifting and squeezing mechanism is a scissor type and mainly includes: a lifting platform 81, a fixed frame 82, a lead screw 86, a nut 87, fork arm one 84, fork arm two 85, and a squeezing motor 83. The lifting mechanism is installed inside the separating rotor 55 and close to the centrifugal shaft 73. The mounting cavity of the lifting mechanism communicates with the separating chamber 56. The lifting platform 81 is located inside the side wall of the separating chamber 56 near the centrifugal shaft 73 and is flush with the side wall, forming part of the side wall of the centrifugal separating chamber 56. The squeezing motor 83 drives the lead screw 86 to rotate, causing the nut 87 to move the two fork arms one 84 or fork arm two 85, further driving the lifting platform 81 to rise and fall. After the bag assembly box 40 is loaded into the separating chamber 56, the lifting platform 81 rises above the inner wall of the separating chamber 56, passing through the inner side of the bottom cover frame to expel the fluid from the bag body in the squeezing chamber 53 of the bag assembly box 40 in the separating chamber 56.

[0106] Optionally, the side walls extending around the lifting platform 81 are sealed to the fixed frame 82 via sealing cups 88 to prevent leakage of lubricant from the lifting and pressing mechanism.

[0107] The extrusion motor 83 can be a geared motor, a servo motor, or a stepper motor.

[0108] The lifting and pressing mechanism can also be a linear motion actuator such as an electric push rod or an electric cylinder that is vertically connected to the lifting platform 81.

[0109] The hot-melt assembly is installed inside the hot-melt chamber 69. The hot-melt assembly mainly includes: a hot-melt moving head 64, a hot-melt stationary head 65, a moving head driver 63, and an RF transmitter 67. The hot-melt moving head 64 is generally a "fork"-shaped structure composed of a hot-melt connection part and multiple hot-melt heads, preferably four heads. Figure 6 Four heat-fusion heads are shown. The heat-fusion connection part is connected to the shaft of the moving head driver 63, and a spring (not shown) is installed on the shaft of the moving head driver 63. The heat-fusion stationary head 65 is arranged opposite to the head of the heat-fusion moving head 64, and the heat-fusion stationary head 65 is fixed on the heat-fusion chamber cover 68. The heat-fusion head of the heat-fusion moving head 64 or the heat-fusion stationary head 65 is connected to the radio frequency generator 67. Vertical semi-cylinders or trapezoidal columns are provided on the opposing surfaces of the heat-fusion heads and the heat-fusion stationary head 65.

[0110] Optionally, multiple radio frequency generators 67 are installed in the separating rotor 55, and one radio frequency generator 67 is connected to the hot melt head or hot melt stationary head 65 of the hot melt moving head 64 in the separating unit; or one radio frequency generator 67 is installed and one radio frequency generator 67 is connected to the hot melt head or hot melt stationary head 65 of multiple (e.g., 6) hot melt moving heads 64 in the separating unit.

[0111] Optionally, multiple radio frequency generators 67 are installed in the device housing, and one radio frequency generator 67 is connected to the hot melt head or hot melt stationary head 65 of the hot melt moving head 64 in the separation unit via a slip ring; or one radio frequency generator 67 is installed, and one radio frequency generator 67 is connected to the hot melt heads or hot melt stationary heads 65 of multiple (e.g., 6) hot melt moving heads 64 in the separation unit via a slip ring.

[0112] The moving head driver 63 is preferably an electromagnet, but it can also be a geared motor, a stepper motor, or a servo motor.

[0113] A hot-melt chamber cover 68 is mounted on a hot-melt chamber 69 and has a cavity 58 and toothed grooves. A locking tongue 59 and a button 62 are located within the cavity 58. The locking tongue 59 protrudes into the cavity 58. When the fluid diversion box 2 is placed inside the cavity 58, the locking tongue 59 secures the fluid diversion box 2 to the cavity 58. Pressing the button 62 unlocks the fluid diversion box 2 from the cavity 58. Other locking mechanisms can also be used between the fluid diversion box 2 and the cavity 58. Multiple toothed grooves for the transfer tubes of the loading bag assembly are provided between the cavity 58 and the edge of the hot-melt chamber cover 68. The "fork"-shaped hot-melt head and the hot-melt fixed head 65 of the hot-melt moving head 64 are located on both sides of the toothed grooves of the hot-melt chamber cover 68. The hot-melt fixed head 65 is fixed to the hot-melt chamber cover 68, and the hot-melt head of the hot-melt moving head 64 is slidably mounted on the hot-melt chamber cover 68.

[0114] The grooves on the side wall of the separation chamber 56 and the grooves on the hot melt chamber cover 68 together form multiple hot melt grooves 57, and at least three hot melt grooves 57 penetrate the separation chamber 56 and the cavity 58.

[0115] Optionally, the hot melt chamber 69 is connected to the separation chamber 56, the edge of the hot melt chamber cover 68 forms part of the side wall of the hot melt chamber 69, and the hot melt chamber cover 68 is provided with a toothed groove, which separately forms the hot melt groove 57.

[0116] The moving head driver 63 drives the thermoforming moving head 64, shortening the gap between the thermoforming head and the thermoforming stationary head 65 and clamping the transfer tube within the thermoforming groove 57. The radio frequency generator 67 supplies radio frequency energy to the thermoforming head of the thermoforming stationary head 65 or the thermoforming moving head 64. When the transfer tube is thermofused, the spring on the shaft of the moving head driver 63 maintains the pressure of the thermoforming head on the transfer tube, and the transfer tube is thermofused and sealed. After the transfer tube is sealed, the thermoforming head returns to its original position. The semi-cylindrical or trapezoidal column on the thermoforming head and the thermoforming stationary head 65 creates a small, thin sealing groove on the sealed section of the transfer tube after thermoforming, facilitating manual disconnection of the transfer tube after sealing.

[0117] Photodetector. A first photodetector 60 is provided at the bottom of the cavity 58 to detect whether plasma is present or absent in the detection cavity 21 of the fluid switching box 2, and further detect the concentration or number of fat particles and blood cells in the plasma; preferably, a second photodetector 61 is provided at the bottom of the cavity 58 to detect the color mark, QR code or barcode on the fluid switching box 2 to identify different bag groups of the bag group 1 with the fluid switching box.

[0118] Optionally, the first photodetector 60 and the second photodetector 61 are mounted on the equipment cover above the cavity 58. As the separating rotor 55 rotates, the first photodetector 60 and the second photodetector 61 emit beams downwards respectively. The second photodetector 61 detects color marks, barcodes, QR codes, etc. on multiple fluid reversing boxes 2 to identify the blood bag group type. The first photodetector 60 periodically detects the presence or absence of plasma in the detection chamber 21 of the multiple cavities 58 of the fluid reversing box 2, and further detects the concentration or number of fat particles and blood cells in the plasma.

[0119] Optionally, the first photodetector 60 is installed on both sides or at the bottom of the hot-melt tank 57 of the fourth transfer tube 19 connected to the fluid reversing box 2 in each centrifugal separation unit, such as by-beam photodetectors installed on both sides of the tank. After the bag assembly with the fluid reversing box is installed onto the separation rotor, the photodetector detects the presence or absence of plasma in the fourth transfer tube 19, and further detects the concentration or number of fat particles and blood cells in the plasma.

[0120] Optionally, if the air pump 75 is not installed inside the housing 42, the air pump 75 is installed inside the separator rotor 55. An air nozzle 80 is provided on the separator chamber 56, and the air pump 75's inflation port communicates with the air nozzle 80 inside the separator chamber 56. An air hole 72 is provided on the bag assembly box 40. After the bag assembly box 40 is inserted into the separator chamber 56, the air nozzle 80 and the air hole 72 on the bag assembly box 40 are sealed together. The air pump 75 is used to inflate the airtight interlayer or air bladder between the membrane cup cavity 43 sidewall of the bag assembly box 40 and the flexible membrane 50. After the bag assembly box 40 is removed from the separator chamber 56, the air in the airtight interlayer or air bladder is discharged.

[0121] Optionally, a valve rotation assembly is mounted on the separator rotor 55, including a plug shaft 66 and a shaft actuator 74 installed within the heat-melting chamber 69. One end of the plug shaft 66 is a notched end or a wedge-shaped head, preferably a notched end. The end of the plug shaft 66 protrudes into the cavity 58 through the heat-melting chamber cover 68. After the plug-type fluid diversion box 2 is placed into the cavity 58, the end of the valve core 24 and the end of the plug shaft 66 are locked together (the wedge-shaped head of the valve core 24 is inserted into the notch on the plug shaft 66, or the wedge-shaped head of the plug shaft 66 is inserted into the notch on the valve core 24). The shaft actuator 74 drives the plug shaft 66 to rotate, which in turn drives the valve core 24 to rotate.

[0122] The axis driver 74 can be a stepper motor, servo motor, servo motor, or rotary electromagnet.

[0123] To maintain centrifugal force balance, a balance disc is installed inside or outside the separating rotor 55. The balance disc is a liquid regulating disc and / or a slider regulating disc, and the central axis of the balance disc is substantially coincident with the axis of the centrifugal shaft 73. The liquid regulating disc (not shown in the figure) has at least one hollow annular cavity, and at least one vertical partition is provided inside the annular cavity. At least one liquid flow hole is provided on the vertical partition, and the annular cavity is filled with liquid. The slider regulating disc has at least one annular cavity 77, and multiple sliders 76 are arranged inside the annular cavity 77. The radial cross-sectional diameter of the annular cavity 77 is larger than the diameter of the sliders 76. When the separating rotor 55 rotates, the sliders 76 can slide inside the annular cavity 77. Because the hematocrit of blood cells is different in each centrifugal separation unit, during the blood centrifugation process, the mass of the component blood transferred from each separation chamber 56 bag group box 40 squeezing chamber 53 bag to other bags placed in the partition is inconsistent, and the displacement of accessories such as lifting platform 81, fork arm 84, and fork arm 85 in the lifting mechanism causes imbalance. At the critical rotation speed, the liquid regulating plate and / or the slider regulating plate balance the separation rotor 55.

[0124] Below, with Figure 1 The following are the operating steps for preparing different blood components in the separation equipment using the blood contained in the bag group 1 with the fluid reversing box shown as an example: the fluid reversing box 2 is a plug-type fluid reversing box, a valve rotation assembly is installed on the separation rotor 55, an air pump 57 is installed inside the separation rotor 55, and a first photodetector 60 and a second photodetector 61 are installed in the cavity 58.

[0125] Figure 1 The first type of bag assembly with a fluid reversing box shown is suitable for separating whole blood into plasma, concentrated platelets, and leukocyte-reduced suspended red blood cells.

[0126] The operation is as follows: The first step is the installation of the blood bags. Figure 1 The bag assembly 1 with fluid reversing box shown is installed in place within the separation rotor 55 of the centrifugal separator.

[0127] Before the installation phase begins, the cell bag 11 contains a certain amount of whole blood (e.g., 500 mL of whole blood with maintenance solution). The third transfer tube 9 connecting the cell bag 11 to the needle 10 is heat-sealed, and the needle 10 is sealed and discarded after being cut off.

[0128] The bag assembly 1 with the fluid reversing box is loaded into the bag assembly box 40. The bag assembly box 40 is selected as a "four-chamber double-opening" type bag assembly box 40.

[0129] A cell bag 11 containing a certain amount of blood (e.g., 500 mL, containing preservation solution) is inserted into the bottom cover 41 between the semi-enclosed bottom cover side plate 49 and the bag body pad 48. The bottom cover 41 is closed, and the cell bag 11 is placed into the squeezing chamber 53. A liquid bag 16 containing a certain amount of red blood cell preservation solution is placed into the membrane cup chamber 43. An empty component bag 1 6, a transfer bag 15, and a white blood cell filter 18 are placed into the box cup chamber 44. An empty component bag 2 8 is inserted between the upper semi-enclosed box body side plate 46 and the concave area of ​​the box body 42. The box body is closed. The top cover 47 and the empty component bag 2 8 are inserted into the platelet collection chamber 51. The component bag 2 8 is pressed tightly by the cover protrusion 54 on the top cover 47 and the body protrusion 45 on the box body 42. The component bag 2 8 inserted into the platelet collection chamber 51 is roughly divided into two areas with the bottom connected (the cover protrusion 54 and the body protrusion 45 are vertical). The first transfer tube 3 and the second transfer tube 4 are located at the upper part of the two areas respectively, and the gap position of the arc-shaped top is higher than the first transfer tube 3 and the second transfer tube 4 of the bag body on the horizontal line.

[0130] The bag assembly boxes 40 of bag assembly 1 with fluid reversing boxes are paired and balanced, and the paired and balanced bag assembly boxes 40 are symmetrically placed into the separation chamber 56 on the separation rotor 55. The fluid reversing box 2 is installed into the corresponding cavity 58 on the separation rotor 55. The locking tongue 59 fixes the fluid reversing box 2. The valve core handle 30 on the valve core 24 and the end of the stopcock shaft 66 are locked together. The first transfer tube 3, the fourth transfer tube 19, the sixth transfer tube 17 connected to the fluid reversing box 2, and the second transfer tube 4 between component bag 1 6 and component bag 2 8 are locked into the hot melt groove 57. The air nozzle 80 at the bottom of the separation chamber 56 is sealed to the air hole 72 on the bag assembly box 40.

[0131] The second step is the centrifugation of whole blood.

[0132] In cell bag 11, whole blood is roughly separated into four layers. First, centrifuge motor 70 starts, driving the separation rotor 55 to rotate stably. The second photoelectric detector 61 on the centrifuge separation device determines the type of the loaded bag group, for example, by identifying the color recognition part or QR code / barcode on the fluid reversing box 2, to determine whether the blood bag loaded into the separation chamber 56 is a 200mL, 300mL, or 400mL blood bag, and whether it is a blood bag for collecting platelets, etc. Second, the centrifugation rotor 55 rotates stably at the predetermined centrifugation speed (e.g., 3000RPM) to achieve the predetermined centrifugation stratification of whole blood. The centrifuge rotor 55 rotates stably at this centrifugation speed for a predetermined time (e.g., 6 minutes). The whole blood in cell bag 11 is separated into four layers. The blood in the bag is divided into a plasma layer, a platelet-rich plasma layer, a white blood cell layer (mainly containing white blood cells), and a red blood cell layer from the top of the bag near the centrifuge shaft 73 to the bottom of the bag away from the centrifuge shaft 73. There is some overlap between the layers.

[0133] The third step is the collection of component blood. First, before the separation rotor 55 starts rotating or at any speed during the centrifugation stage, the shaft driver 74 inside the separation rotor 55 drives the stopcock shaft 66 and valve core 24 to rotate at a certain angle (e.g., 90°). The guide channel 26 on the valve core 24 connects the mixing interface 25 of the fluid diversion box 2 with the outflow interface 22. Second, after the predetermined centrifugation rotation time of the centrifugation stage ends, and a certain rotation speed is maintained (e.g., 3000 RPM), the extrusion motor 83 in the lifting and extrusion mechanism drives the lifting platform 81 to move vertically into the separation chamber 56. The lifting platform 81 pushes the bottom plate 52 and the bag pad 48 to extrude the cell bag 11. The stratified plasma, platelet-rich plasma, and white membrane layer (mainly containing white blood cells) in the cell bag 11 are extruded in a constant amount (e.g., about 150 mL / min). The squeezed plasma, platelet-rich plasma, and white blood cell layer (mainly containing leukocytes) sequentially enter the separation chamber through the fourth transfer tube 19, mixing interface 25, guide channel 26, and probe chamber 21 for further washing and separation. Mixed leukocytes and erythrocytes are retained in the separation chamber. Plasma and platelets enter component bag two 8 through the outflow interface 22 and the first transfer tube 3 for a third centrifugal separation. Platelets are deposited in component bag two 8, while plasma is fed from component bag two 8 through the second transfer tube 4 and collected in component bag one 6. The rotational speed of the separation rotor 55 and the rotational speed of the extrusion motor 83 (which determines the extrusion speed of the blood components) work together to ensure that as many leukocytes and mixed erythrocytes as possible are retained in the separation chamber, and that as many platelets as possible are collected in component bag two 8. The platelets in component bag 28 are centrifuged again in different areas, which prolongs the residence time of platelets in component bag 28 and can effectively collect platelets from plasma. The gap between the two bag pieces at the top edge of the cover ridge 54 and the body ridge 45 near the concave top edge allows a certain amount of air to enter component bag 16 from component bag 28.

[0134] When the first photodetector 60 detects a set number or concentration of red or white blood cells flowing through the detection chamber 21 of the fluid reversing box 2, the squeezing motor 83 stops rotating, and the blood components in the cell bag 11 are no longer squeezed out.

[0135] The fourth step is the addition of red blood cell preservation solution. After all the squeezing motors 83 on the centrifuge units stop rotating, the speed of the centrifuge motor 70 begins to slow down until the separation rotor 55 stops rotating. First, after the squeezing motor 83 stops rotating, after the separation rotor 55 rotates or stops rotating, the shaft driver 74 corresponding to the centrifuge unit inside the separation rotor 55 again drives the stopcock shaft 66 and the valve core 24 to rotate a certain angle (e.g., 90°). The valve core 24 blocks the connection between the mixing port 25 and the outflow port 22 of the fluid diversion box 2, and connects the mixing port 25 and the inflow port 27 of the fluid diversion box 2 through the guide channel 26. Second, the squeezing motor 83 rotates in the opposite direction until the lifting platform 81 returns to its initial position. Finally, the air pump 75 is started, and a certain amount (e.g., 120 mL) of air is injected into the interlayer or air bladder between the wall of the membrane cup cavity 43 and the flexible membrane 50. The red blood cell preservation solution in the liquid bag 16 enters the cell bag 11 through the sixth transfer tube 17, the inflow interface 27, the guide channel 26, the mixing interface 25, and the fourth transfer tube 19.

[0136] Step 5: Heat sealing of the transfer tube. After the air pump 75 in the centrifugal separation unit stops filling, the moving head driver 63 in the heat sealing chamber 69 drives the heat sealing moving head 64 to move towards the heat sealing stationary head 65. The head of the heat sealing moving head 64 and the heat sealing stationary head 65 clamp the transfer tube in the heat sealing groove 57 for a certain period of time (e.g., 5 seconds). At the same time, the radio frequency generator 67 supplies radio frequency energy to the heat sealing moving head 64 or the heat sealing stationary head 65, and the transfer tube in the heat sealing groove 57 is heat-sealed. The heat sealing of the transfer tube is completed, and the heat sealing moving head 64 returns to its initial position.

[0137] Step 6: Preparation and preservation of blood components.

[0138] Remove bag assembly 40 and bag assembly 1 with fluid reversing box, and disconnect the heat-sealed transfer tube. Plasma is collected and stored in component bag 1 6, platelets are collected in component bag 2 8, red blood cells are prepared into a red blood cell suspension and stored in cell bag 11, some white blood cells are collected in fluid reversing box 2, and the empty liquid bag 16 is discarded.

[0139] Further break the easy-break plug 12 on the cell bag 11, and the red blood cell suspension in the cell bag 11 enters the transfer bag 15 through the white blood cell filter 18. Heat-seal and disconnect the fifth transfer tube 14 between the white blood cell filter 18 and the transfer bag 15. The deleukocyte-resuspended red blood cells are collected and stored in the transfer bag 15, and the white blood cell filter 18 and the empty cell bag 11 are discarded.

[0140] The air in the interlayer between the membrane cup cavity 43 wall and the flexible membrane 50 is expelled, and the flexible membrane 50 adheres to the membrane cup cavity 43 wall.

[0141] Different combinations of bag groups 1 with fluid reversing boxes result in differences in the selection of bag group box 40, the installation stage of the centrifugal separation equipment, the centrifugal separation stage, the component collection stage, and the component blood preparation stage.

[0142] The following is an example of a separation operation for a bag assembly with a fluid switching box used for washing cells, wherein: the fluid switching box 2 is a plug-type fluid switching box, a valve rotation assembly is installed on the separation rotor 55, and an air pump 57 is installed inside the separation rotor 55.

[0143] The first step is to install the washed blood bags.

[0144] Before the installation phase begins, the fourth transfer tube 19 is aseptically connected to a bag containing washed cells; the liquid bag 16 contains a predetermined amount of cell washing solution (e.g., 400 mL of physiological saline); the component bag 6 is an empty bag to receive waste cell washing solution. Choose either a "three-chamber single-opening" bag cassette 40 or a "double-chamber" bag cassette 40.

[0145] When selecting the "three-chamber single-opening" bag assembly box 40, the bag containing the washed cells is placed into the compression chamber 53, the empty component bag 6 is placed into the box cup chamber 44, and the liquid bag 16 is placed into the membrane cup chamber 43.

[0146] When selecting the "dual-chamber" bag kit 40, the bag containing the washed cells is placed into the compression chamber 53, and the component bag 6 and the liquid bag 16 are placed into the membrane cup chamber 43.

[0147] After the bag assembly boxes 40 are paired and balanced, they are symmetrically placed into the separation chamber 56 of the separation rotor 55. The fluid reversing box 2 is installed into the cavity 58 on the separation rotor 55, and the locking tongue 59 fixes the fluid reversing box 2. The valve core handle 30 on the valve core 24 and the end of the plug shaft 66 are locked together. The first transfer pipe 3, the fourth transfer pipe 19, and the sixth transfer pipe 17 connected to the fluid reversing box 2 are locked into the hot melt groove 57.

[0148] The second step is to mix the cells and washing solution thoroughly.

[0149] Before the separator rotor 55 rotates, firstly, the shaft actuator 74 inside the separator rotor 55 drives the stopcock shaft 66 and the valve core 24 to rotate at a certain angle. The guide channel 26 on the valve core 24 connects the mixing port 25 and the inflow port 27 of the fluid diversion box 2. Secondly, the air pump 75 starts, filling a certain amount (e.g., 100 mL) of air into the sealed interlayer or air bladder between the membrane cup cavity 43 wall and the flexible membrane 50. The flexible membrane 50 further squeezes a certain amount of washing liquid (e.g., 100 mL of physiological saline) in the liquid bag 16 into the bag containing the washed cells through the sixth transfer tube 17, the inflow port 27, the mixing port 25, and the fourth transfer tube 19. Subsequently, the shaft actuator 74 inside the separator rotor 55 drives the stopcock shaft 66 and the valve core 24 to rotate at a certain angle (e.g., 90°). The valve core 24 blocks the connection between the mixing port 25 and the inflow port 27.

[0150] The centrifugal motor 70 starts and rotates clockwise and counterclockwise alternately multiple times at a certain speed (e.g., 800 RPM). During this time, the squeezing motor 83 rotates in both directions, driving the lifting platform 81 to rise and fall multiple times, thus mixing the cells and washing liquid in the bag containing the washed cells.

[0151] The third step is centrifugation. The cell suspension inside the bag containing washed cells is roughly separated into a cell layer and a washing liquid layer by centrifugation. First, the centrifuge motor 70 starts, driving the separation rotor 55 to rotate stably. Second, a photoelectric detector determines the type of blood bag being transferred. For example, it identifies the color marking on the fluid reversing box 2 to determine that the blood bag loaded into the separation chamber 56 is a washed cell blood bag. The centrifugation reaches the predetermined rotational speed required for stratification (e.g., 3000 RPM), and the separation rotor 55 rotates stably at this centrifugation speed for a predetermined time (e.g., 6 minutes), separating the cell suspension in the washed cell bag into two layers. The cell suspension inside the bag separates sequentially into a washing liquid layer and a cell layer from the top of the bag near the centrifuge shaft 73 to the bottom of the bag away from the centrifuge shaft 73.

[0152] The fourth step is the collection of washing waste liquid.

[0153] At the end of the predetermined centrifugation rotation time in the centrifugation stage, at a certain rotation speed (e.g., 2000 RPM), firstly, the shaft driver 74 inside the separation rotor 55 drives the stopcock shaft 66 to rotate, further driving the valve core 24 on the fluid reversing box 2 to rotate at a certain angle (e.g., 90°). The guide channel 26 on the valve core 24 connects the mixing port 25 and the outflow port 22 of the fluid reversing box 2. Secondly, the extrusion motor 83 in the lifting and extrusion mechanism starts to rotate, and the lifting platform 81 moves vertically into the separation chamber 56. The lifting platform 81 pushes the bottom plate 52 and the bag pad 48 to extrude the washing cell bag. The air and washing liquid layer inside the washing cell bag are extruded in sequence at a constant rate (e.g., about 120 mL / min). The extruded air and washing liquid layer enter the component bag 6 after passing through the fourth transfer tube 19, the mixing port 25, the guide channel 26, and the detection chamber 21 in sequence. When the first photodetector 60 detects a set number or concentration of cells flowing through the detection chamber 21 of the fluid reversing box 2, the squeezing motor 83 stops rotating, and the washing liquid layer in the corresponding washing cell bag is no longer squeezed out.

[0154] The centrifugal motor 70 begins to decrease in centrifugal speed until it stops, and the lifting platform 81 returns to its initial position.

[0155] The second step involves mixing the red blood cells and washing solution evenly. The third step involves centrifugation. The fourth step involves collecting the washing solution as one washing cycle. This process is repeated two more times or as many times as needed.

[0156] Step 5: Preparation of washed cells After the last cycle of washing is completed, the second step of mixing the cells and washing solution is repeated once more. A certain amount of washing solution (e.g., 100 mL of physiological saline) in liquid bag 16 is introduced into the washing cell bag containing concentrated red blood cells, and the cells in the washing cell bag are prepared as washing cells.

[0157] Step 6: Heat fusion sealing of the transfer tube.

[0158] Centrifugal motor 70 stops rotating. Inside the heat fusion chamber 69, moving head driver 63 drives heat fusion moving head 64 to move towards heat fusion stationary head 65 and clamp the transfer tube in the heat fusion groove 57 for a certain period (e.g., 5 seconds). Radio frequency generator 67 supplies radio frequency energy to either heat fusion moving head 64 or heat fusion stationary head 65, and the transfer tube in the heat fusion groove 57 is heat-sealed. Once the heat fusion sealing of the transfer tube is complete, moving head driver 63 drives heat fusion moving head 64 to move in the opposite direction, and heat fusion moving head 64 returns to its initial position.

[0159] Step 7: Red blood cell washing is complete.

[0160] Centrifuge motor 70 stops rotating, the washed cell blood bag is removed, and the heat-sealed transfer tube is disconnected. The cells are prepared into a washed cell suspension and stored in the washed cell blood bag. Fluid switching box 2, component bag containing washing solution 6, and liquid bag 16 are discarded.

[0161] For those skilled in the art, different combinations and modifications can be made to the various bags and components of bag assembly 1 with fluid diversion boxes, and various combinations can be made to the equipment and centrifugal separation operation steps described herein. Therefore, the present invention is not limited to the combinations of bag assembly 1 with fluid diversion boxes exemplified in the specification, and all alternative combinations involving connecting the bag bodies via fluid diversion boxes are within the scope of protection of the present invention.

Claims

1. A bag assembly with a fluid switching box, the bag assembly comprising a fluid switching box (2), a bag body, and a transfer tube, characterized in that: The fluid switching box (2) is a centrifugal plug-type fluid switching box composed of a box body, a first plunger (33), a second plunger (35), and a spring (32). The box body is provided with a first plunger cavity (31), a second plunger cavity (34), an outlet port (22), a mixing port (25), and an inlet port (27). The first plunger cavity (31) is connected to the mixing port (25), the outlet port (22), and the second plunger cavity (34) respectively. The other end of the second plunger cavity (34) is connected to the inlet port (27). The spring (32) and the first plunger (33) are installed in the first plunger cavity (31), and the second plunger (35) is installed in the second plunger cavity (34). When the first plunger (33) is in the stationary position, it closes the connection between the first plunger cavity (31) and the outlet port (22). When the second plunger (35) is in the stationary position, it closes the connection between the first plunger cavity (31) and the second plunger cavity (34). The first plunger (33) compresses the spring (32) and moves within the first plunger cavity (31), connecting the first plunger cavity (31) to the outlet port (22). The second plunger (35) moves within the second plunger cavity (34), connecting the first plunger cavity (31) to the second plunger cavity (34) and closing the connection between the inlet port (27) and the second plunger cavity (34), allowing fluid to enter the outlet port (22) from the mixing port (25) but not from the inlet port (27). After the set centrifugal force is removed, the spring (32) pushes the first plunger (33) to move within the first plunger cavity (31), closing the connection between the first plunger cavity (31) and the outlet port (22), and connecting the inlet port (27) to the second plunger cavity (34), allowing fluid to enter the mixing port (25) from the inlet port (27) but not from the outlet port (22). The fluid switching box (2) has at least one bag body connected to its outflow port (22), mixing port (25), and inflow port (27) via transfer pipes. The fluid switching box (2) has at least one bag body connected to its outflow port (22) and inflow port (27) via transfer pipes, and its mixing port (25) is connected to a section of transfer pipe with a closed port.

2. The bag assembly with fluid reversing box according to claim 1, characterized in that: The fluid switching box (2) is also provided with a detection chamber (21) and / or a separation chamber. The detection chamber (21) is located between the mixing interface (25) and the first plunger chamber (31) or between the first plunger chamber (31) and the outflow interface (22). The separation chamber is located between the outflow interface (22) and the first plunger chamber (31).

3. The bag assembly with fluid reversing box according to claim 2, characterized in that: The separation chamber is a funnel-shaped separation chamber (20), which is a cavity in the shape of a funnel. The front opening of the funnel-shaped cavity is connected to the first plunger cavity (31) or the probe cavity (21), and the rear opening of the funnel-shaped cavity is connected to the outflow interface (22). Alternatively, the separation chamber may be a pipe-type separation chamber (29), which is a cavity in the shape of a curved and coiled pipe. One end of the pipe-type separation chamber (29) is connected to the outflow interface (22), and the other end is connected to the first plunger cavity (31) or the probe cavity (21).

4. An apparatus for preparing a suspension in a bag assembly with a fluid reversing box into different components, wherein a centrifugal motor (70) drives a separating rotor (55) to rotate via a centrifugal shaft (73), the separating rotor (55) is provided with a lifting mechanism, the bag assembly includes a fluid reversing box (2), a bag body, and a transfer tube, the fluid reversing box (2) is a centrifugal plug-type fluid reversing box composed of a box body, a first plunger (33), a second plunger (35), and a spring (32), the box body is provided with a first plunger cavity (31) and a second plunger cavity (32). 4) Outflow port (22), mixing port (25), inflow port (27); the first plunger cavity (31) is connected to the mixing port (25), the outflow port (22), and the second plunger cavity (34) respectively, and the other end of the second plunger cavity (34) is connected to the inflow port (27); a spring (32) and a first plunger (33) are installed in the first plunger cavity (31), and a second plunger (35) is installed in the second plunger cavity (34); when the first plunger (33) is in the stationary position, it closes the first plunger cavity (31). When the first plunger (33) is in the stationary position, the first plunger (35) closes the connection between the first plunger cavity (31) and the second plunger cavity (34) when the first plunger (33) is in the stationary position and the first plunger (33) closes the connection between the first plunger cavity (31) and the second plunger cavity (34). Under the set centrifugal force, the first plunger (33) compresses the spring (32) and moves within the first plunger cavity (31), making the first plunger cavity (31) and the second plunger cavity (34) connect and close the connection between the inlet port (27) and the second plunger cavity (22). The opening of the plunger cavity (34) allows fluid to enter the outlet port (22) from the mixing port (25) but not the inlet port (27); after the set centrifugal force is removed, the spring (32) pushes the first plunger (33) to move in the first plunger cavity (31), closing the connection between the first plunger cavity (31) and the outlet port (22), and the inlet port (27) and the second plunger cavity (34) are connected, allowing fluid to enter the mixing port (25) from the inlet port (27) but not the outlet port (22). The fluid switching box (2) has at least one bag body connected to its outflow port (22), mixing port (25), and inflow port (27) via transfer pipes. The fluid switching box (2) has at least one bag body connected to its outflow port (22) and inflow port (27) via transfer pipes, and its mixing port (25) is connected to a section of transfer pipe with a closed port. Its characteristic is that: The separator rotor (55) is provided with an open upper separator chamber (56) and a hot melt chamber (69); the separator chamber (56) is used to load the bag assembly box (40); the hot melt chamber (69) is equipped with a hot melt chamber cover (68), the hot melt chamber cover (68) is provided with a cavity (58) corresponding to the separator chamber (56), the cavity (58) is used to load the fluid reversing box (2), a hot melt groove (57) is provided between the side wall of the separator chamber (56) and the cavity (58) of the hot melt chamber cover (68), and hot melt components for hot melting and sealing the transfer tube inside the hot melt groove (57) are installed on both sides of the hot melt groove (57) and inside the hot melt chamber (69); The hot melt assembly includes: a hot melt moving head (64), a hot melt stationary head (65), a moving head driver (63), a radio frequency generator (67), and a spring. The hot melt moving head (64) consists of a fork-shaped hot melt head and a hot melt connection part. The hot melt connection part is connected to the drive shaft of the moving head driver (63). The hot melt head and the hot melt stationary head (65) are installed opposite each other on both sides of the hot melt groove (57). The hot melt head or the hot melt stationary head (65) of the hot melt moving head (64) is connected to the radio frequency generator (67). The radio frequency generator (67) provides radio frequency energy for the hot melt sealing of the transfer tube. The moving head driver (63) drives the hot melt moving head (64) to move. A spring is installed on the drive shaft. The spring is adapted to maintain the pressure of the hot melt moving head (64) on the transfer tube when the transfer tube is hot melt sealed. The bag assembly box (40) is used to load the bags on the bag assembly with the fluid reversing box. It includes a box body (42) and a bottom cover (41). The box body (42) has an open membrane cup cavity (43) at the top. The inner wall of the membrane cup cavity (43) is covered with a flexible membrane (50). The flexible membrane (50) and the wall of the membrane cup cavity (43) are not completely connected to form a closed expansion and contraction space, or the flexible membrane (50) and the membrane cup cavity (43) are not completely connected to form a non-closed space and an airbag is installed in the non-closed space. The bottom cover (41) includes a bottom cover frame and a bag body pad (48). The bag body pad (48) is flexible and its edge is fixed to the bottom cover frame. The bottom cover frame is movably connected to the box body (42). An openable and closable compression cavity (53) is formed between the box body (42) and the bottom cover (41). It also includes an air pump (75), which is installed on the bag assembly box (40), and the air pump (75) inflation port is connected to the sealed expansion and contraction space or airbag between the flexible membrane (50) and the membrane cup cavity (43); Alternatively, the air pump (75) is installed on the separating rotor (55), and the inner wall of the separating chamber (56) is provided with an air nozzle (80) that is connected to the air inlet of the air pump (75). The bag box (40) has an air hole (72) on its body (42). The air hole (72) connects the sealed space or air bladder between the flexible membrane (50) and the membrane cup cavity (43) with the outside of the body (42). After the bag box (40) is loaded into the separating chamber (56), the air hole (72) and the air nozzle (80) are sealed together. The lifting mechanism is installed inside the separating rotor (55) and close to the centrifugal shaft (73). The mounting cavity of the lifting mechanism is connected to the separating chamber (56). When the lifting end face of the lifting mechanism is raised, it is higher than the inner wall of the separating chamber (56) and passes through the inner side of the bottom cover frame to generate extrusion force on the fluid in the bag of the bag group box (40) extrusion chamber (53). A control unit (79) is electrically connected to the hot melt assembly, the air pump (75), and the lifting mechanism. The control unit (79) controls the state of the hot melt assembly, the air pump (75), and the lifting mechanism.

5. The apparatus for preparing different components from a suspension in a bag assembly with a fluid reversing box according to claim 4, characterized in that: The bag box (40) also includes a top cover (47) and / or a cup cavity (44) on the box body (42); the top cover (47) and the box body (42) are movably connected to form an openable collection cavity (51), and the concave cavity of the box body (42) constituting the collection cavity (51) is provided with a body protrusion (45), and the concave cavity of the top cover (47) is provided with a cover protrusion (54); the cup cavity (44) is an open cavity at the top of the box body (42).

6. The apparatus for preparing suspensions in a bag assembly with a fluid reversing box into different components according to claim 4, characterized in that: The separator rotor (55) is also provided with a valve rotation assembly in the hot melt chamber (69), including a shaft driver (74) and a stopcock shaft (66). The end of the stopcock shaft (66) is exposed in the cavity (58), and the shaft driver (74) drives the stopcock shaft (66) to rotate.

Images