A tube-type continuous blood component separation device

Abstract

The present invention discloses a tubular continuous blood component separation device, which aims to provide a blood component separation device with high component separation purity, stable quality of component blood products, less donor cell loss, and continuous and accurate collection. The present invention is implemented through the following technical scheme: it includes a tubular centrifuge with four fixed heads and four component blood inlet and outlet tubes connected to the fixed heads on the tubular centrifuge, the component blood inlet and outlet tubes are gathered into an elastic back-twisting tube bundle, the whole blood and component blood inlet and outlet inside the tubular centrifuge are arranged in sequence according to the distance from the centrifugal rotation center line, and the designated blood component collection is achieved by adjusting the blood cell centrifugal stratification interface.

Description

Technical Field

[0001] The present invention relates to a continuous blood component separation device which is mainly used for blood cell separation, platelet apheresis, peripheral blood stem cell collection, plasma collection, lymphocyte collection, plasma exchange therapy, lymphoplasma exchange therapy, red blood cell exchange therapy and other component blood collection and treatment. Background Art

[0002] Blood component transfusion is a new blood transfusion technology developed in recent decades with the progress of medical science and medical technology. The emergence of blood component transfusion is a milestone in the development of modern blood transfusion, and blood component transfusion is obviously superior to whole blood transfusion. Compared with whole blood transfusion, blood component transfusion has the following advantages: 1. High purity and good efficacy; 2. Safe transfusion and small side effects; 3. Good stability, easy to store and transport; 4. Comprehensive utilization and saving blood.

[0003] Stem cells are produced in large quantities by the bone marrow, and a small amount of them are released into the blood, which are called peripheral blood stem cells. Peripheral blood stem cell transplantation is an effective treatment for solid tumors such as malignant blood diseases, lymphomas, and breast tumors. Even with the use of stem cell mobilization drugs, the content of stem cells in peripheral blood is still very scarce. Therefore, the blood component separation device suitable for peripheral blood stem cell collection needs to have the function of dynamically adjusting the blood stratification interface, so that the originally scarce peripheral blood stem cells can be gathered in large quantities in the centrifuge and then collected at one time.

[0004] Human blood is composed of red blood cells, white blood cells, platelets, plasma and other components. Component blood donation is to separate and extract the designated blood components from the donor's blood using a blood component separation device, and return the remaining components to the donor. In the quality control requirements for component blood collection, high requirements are placed on the cell concentration and purity contained in the component blood. The common blood component separation devices on the market currently include cup-type centrifugal separation devices represented by the MCS+ products of the American Blood Technology Company and bag-type centrifugal separation devices represented by the Trima products of the Japanese Terumo Bister Company. The above separation devices all have the following problems and defects:

[0005] 1. Cup type centrifugal separation device:

[0006] The cup - type centrifugal separation device belongs to the intermittent centrifugal separation device. Its separation device uses a fixed - volume centrifugal cup as the centrifuge separator. The fixed - volume centrifugal cup has two ports, one of which is the whole - blood inlet and the other is the component - blood outlet. Its working principle is that anticoagulated whole blood enters the rotating fixed - volume centrifugal cup from the whole - blood inlet. Various components in the anticoagulated whole blood are stratified under the action of centrifugal force due to different densities. When the cells fill the centrifugal cup, the component blood will flow out to the component - blood outlet in turn from the component blood with lower density to the component blood with higher density. Since it cannot dynamically and freely adjust the position of the blood - cell stratification interface during a single collection process, and the component - blood overflow port is not parallel to the position of the blood - stratification interface, it has to adopt methods such as elutriation surfing to separate component blood to obtain component blood that meets the quality - control requirements. It has problems and defects such as excessive extracorporeal blood circulation volume of donors, high unqualified rate of component - blood apheresis, difficulty in applying to the collection of peripheral - blood stem cells, lymphocyte collection, and relatively low component - blood separation rate. In addition, since the cup - type centrifugal separation device belongs to the intermittent centrifugal separation device, it will cause a sharp fluctuation in the patient's blood volume during the treatment of blood diseases such as plasma exchange and lymphocyte - plasma exchange, resulting in adverse symptoms such as arrhythmia, chest tightness, nausea, etc.

[0007] 2. The bag - type centrifugal separation device:

[0008] The bag - type centrifugal separation device belongs to the continuous centrifugal separation device. Its separation device is a ring - shaped centrifugal belt. The ring - shaped centrifugal belt generally has four ports, one of which is the anticoagulated - whole - blood inlet, and the other three are the outlets for three kinds of component blood. Its working principle is that anticoagulated whole blood enters the rotating centrifugal belt. Various components in the anticoagulated whole blood are stratified under the action of centrifugal force due to different densities, and the stratified component blood flows out from the corresponding component - blood outlet. Since the area of the blood - cell stratification interface is too large during its separation process, the thickness of the stratified area of each component blood cell is very thin. Using conventional methods to extract stratified cells from the stratified pipe orifice cannot meet the quality - control requirements for the collection of component blood. To meet the quality - control requirements for the collection of component blood, it uses an LRS centrifuge chamber for secondary centrifugal separation. This method will cause a large number of donor white blood cells to get stuck in the LRS centrifuge chamber and cannot be transfused back into the donor's body. It has problems and defects such as relatively large loss of donor white blood cells.

[0009] To simultaneously meet the requirements of blood - cell separation, apheresis of platelets, collection of peripheral - blood stem cells, plasma collection, lymphocyte collection, plasma exchange, lymph - plasma exchange, red - cell exchange, etc. for component - blood collection and treatment, reduce the risks in component - blood collection and blood treatment, and achieve the best component - blood collection and blood - treatment effects, a tube - type continuous blood - component separation device should simultaneously meet the following technical characteristics:

[0010] 1. The area of the component - blood stratification interface is small enough to make the thickness of the component - blood cell stratification area higher;

[0011] 2. The position of the stratified interface of each component blood can be dynamically adjusted by adjusting the flow rates of anticoagulated whole blood flowing into the centrifuge and component blood flowing out of the centrifuge, so as to achieve the purpose of collecting the target component blood or aggregating the target component blood cells in the centrifuge.

[0012] 3. The collection port of the component blood should be parallel or approximately parallel to the stratified interface of each component blood.

[0013] 4. When collecting the component blood, a certain centrifugal force needs to be ensured at the corresponding component blood outlet to maintain the stability of the stratified interface of the component blood.

[0014] 5. After the separation is completed, the component blood remaining in the centrifuge can be discharged from the centrifuge and transfused back into the donor's body, and the residue should be small enough.

[0015] 6. There are safe measures for transfusion and evacuation.

[0016] 7. The centrifuge can continuously rotate along a certain axis, and under the action of centrifugal force, the anticoagulated whole blood entering the centrifuge is stratified.

[0017] 8. The anticoagulated whole blood can continuously flow into the centrifuge, and the non-target component blood part can be continuously extruded from the centrifuge. Summary of the Invention

[0018] The object of the present invention is to provide a continuous blood component separation device that can simultaneously meet the requirements of blood cell separation, plateletpheresis, peripheral blood stem cell collection, plasma collection, lymphocyte collection, plasma exchange, lymph plasma exchange, red blood cell exchange and other component blood collection and treatment for the problems and deficiencies existing in the above-mentioned prior art.

[0019] The present invention achieves the above object through the following technical solutions: A tubular continuous blood component separation device, comprising: a tubular centrifuge 1 provided with four fixed heads and an elastic untwisting tube bundle 10 connected to the tubular centrifuge 1, characterized in that: the anticoagulated whole blood inlet tube fixed head 6 of the tubular centrifuge 1 internally fixes the anticoagulated whole blood inlet centrifuge inner tube 12 and externally fixes the anticoagulated whole blood inflow tube 16; the component blood one outlet fixed head 7 of the tubular centrifuge 1 internally fixes the component blood one outlet centrifuge inner tube 13 and externally fixes the component blood one outflow tube 17; the component blood two outlet fixed head 8 of the tubular centrifuge 1 internally fixes the component blood two outlet centrifuge inner tube 14 and externally fixes the component blood two outflow tube 18; the red blood cell outlet tube fixed head 9 of the tubular centrifuge 1 internally fixes the red blood cell outlet centrifuge inner tube 15 and externally fixes the red blood cell outflow tube 19. The anticoagulated whole blood inlet centrifuge inner tube 12, the component blood one outlet centrifuge inner tube 13, the component blood two outlet centrifuge inner tube 14, and the red blood cell outlet centrifuge inner tube 15 are all hard tubes. The anticoagulated whole blood inlet centrifuge inner tube 12 is provided with an anticoagulated whole blood inlet end face 2; the component blood one outlet centrifuge inner tube 13 is provided with a component blood one outlet end face 3 parallel to the centrifugal rotation center line 20; the component blood two outlet centrifuge inner tube 14 is provided with a component blood two outlet end face 4 parallel to the centrifugal rotation center line 20; the red blood cell outlet centrifuge inner tube 15 is provided with a red blood cell outlet end face 5 close to the bottom 91 of the tubular centrifuge tube. At any moment during the collection process, the red blood cell outlet end face 5, the anticoagulated whole blood inlet end face 2, the component blood two outlet end face 4, and the component blood one outlet end face 3 are all located on the same side of the centrifugal rotation center line 20, and the perpendicular distances from them to the centrifugal rotation center line 20 decrease in sequence as the red blood cell outlet end face 5, the anticoagulated whole blood inlet end face 2, the component blood two outlet end face 4, and the component blood one outlet end face 3. The anticoagulated whole blood inflow tube 16, the component blood one outflow tube 17, the component blood two outflow tube 18, and the red blood cell outflow tube 19 are all flexible tubes and converge into an elastic untwisting tube bundle 10 on the same side of the tubular centrifuge 1. The elastic untwisting tube bundle 10 is provided with an elastic untwisting tube bundle fixed head 11.

[0020] The present invention has the following beneficial effects compared with the prior art:

[0021] The quality of the component blood product is stable. The present invention uses a method of rotating the tubular centrifuge 1 with a separation chamber depth greater than the separation chamber width along the centrifugal rotation center line 20 to achieve the separation of anticoagulated whole blood in the tubular centrifuge 1, effectively reducing the area of the blood stratification interface, increasing the thickness of the stratification interface, reducing the possibility of other component blood entering the collection bag, and the quality of the component blood product is stable.

[0022] The component separation purity is high. The component blood collection ports of the present invention are parallel or approaching parallel to the stratification interfaces of each component blood, and a certain centrifugal force is ensured at all component blood outlets during the collection of component blood to maintain the stability of the component blood stratification interface, improving the success rate of the component blood meeting the quality control requirements.

[0023] There is less loss of donor cells. By keeping the tubular centrifuge 1 rotating along the centrifugal rotation center line 20, air is injected into the centrifuge from the component blood first outflow pipe 17 or the component blood second outflow pipe 18, so that the component blood in the centrifuge is extruded from the red blood cell outflow pipe 19 and transfused back into the human body. There is no area in the centrifuge that causes cells to get stuck and unable to be transfused back, reducing the loss of donor cells.

[0024] Continuous and precise collection can be achieved. The present invention adopts two component blood outlets with different distances from the centrifugal rotation center line 20, namely the component blood first outlet end face 3 and the component blood second outlet end face 4. It can accurately detect and estimate the position of each component blood in the tubular centrifuge 1 according to the feedback of the component blood sensor 25, and through the anticoagulated whole blood peristaltic pump 27, the control peristaltic pump 29, and the flow rate of the collection peristaltic pump 30, the position of the component blood stratification interface in the tubular centrifuge 1 is dynamically adjusted, so that continuous and precise collection can be achieved. Brief Description of the Drawings

[0025] Figure 1 It is a schematic cross-sectional view of a tubular continuous blood component separation device of the present invention;

[0026] Figure 2 is Figure 1 Schematic diagram of the rotation and untwisting principle;

[0027] Figure 3 is Figure 1 Schematic diagram of the connection of the single-needle single-donation platelet embodiment;

[0028] Figure 4 is Figure 1 Schematic diagram of the back-transfusion pipeline evacuation process in the single-needle single-donation platelet embodiment;

[0029] Figure 5 is Figure 1 Schematic diagram of the platelet collection process in the single-needle single-donation platelet embodiment;

[0030] Figure 6 is Figure 1 Schematic diagram of the back-transfusion process during the collection in the single-needle single-donation platelet embodiment;

[0031] Figure 7 is Figure 1 Schematic diagram of the back-transfusion process after the collection is completed in the single-needle single-donation platelet embodiment;

[0032] Figure 8 is Figure 1 Schematic diagram of the preferred structural scheme in the single-needle single-donation platelet embodiment;

[0033] Figure 9 is Figure 8 Schematic diagram of the partial enlargement;

[0034] Figure 10 is Figure 1 Schematic connection diagram of the single - needle and single - collection clinical plasma collection example;

[0035] Figure 11 is Figure 1 Schematic diagram of the back - transfusion pipeline evacuation process in the single - needle and single - collection clinical plasma collection example;

[0036] Figure 12 is Figure 1 Schematic diagram of the plasma collection process in the single - needle and single - collection clinical plasma collection example;

[0037] Figure 13 is Figure 1 Schematic diagram of the back - transfusion process during collection in the single - needle and single - collection clinical plasma collection example;

[0038] Figure 14 is Figure 1 Schematic diagram of the back - transfusion process after collection completion in the single - needle and single - collection clinical plasma collection example;

[0039] Figure 15 is Figure 1 Schematic connection diagram of the double - needle peripheral blood stem cell collection example;

[0040] Figure 16 is Figure 1 Schematic diagram of the back - transfusion pipeline evacuation process in the double - needle peripheral blood stem cell collection example;

[0041] Figure 17 is Figure 1 Schematic diagram of the stem cell accumulation process in the double - needle peripheral blood stem cell collection example;

[0042] Figure 18 is Figure 1 Schematic diagram of the back - transfusion process during the procedure in the double - needle peripheral blood stem cell collection example;

[0043] Figure 19 is Figure 1 Schematic diagram of the stem cell collection process in the double - needle peripheral blood stem cell collection example;

[0044] Figure 20 is Figure 1 Schematic diagram of the back - transfusion process after collection completion in the double - needle peripheral blood stem cell collection example;

[0045] In the figure: 1 tubular centrifuge, 2 anticoagulated whole blood inlet end face, 3 first component blood outlet end face, 4 second component blood outlet end face, 5 red blood cell outlet end face, 6 anticoagulated whole blood inlet tube fixing head, 7 first component blood outlet fixing head, 8 second component blood outlet fixing head, 9 red blood cell outlet tube fixing head, 10 elastic torsion-relieving tube bundle, 11 elastic torsion-relieving tube bundle fixing head, 12 anticoagulated whole blood inlet centrifuge inner tube, 13 first component blood outlet centrifuge inner tube, 14 second component blood outlet centrifuge inner tube, 15 red blood cell outlet centrifuge inner tube, 16 anticoagulated whole blood inflow tube, 17 first component blood outflow tube, 18 second component blood outflow tube, 19 red blood cell outflow tube, 20 centrifugal rotation center line, 21 torsion-relieving rotation center line, 22 centrifuge motor, 23 torsion-relieving bracket, 24 fixed frame, 25 component blood sensor, 26 anticoagulant peristaltic pump, 27 anticoagulated whole blood peristaltic pump, 28 reinfusion peristaltic pump, 29 control peristaltic pump, 30 collection peristaltic pump, 31 collection finished product bag, 32 control peristaltic pump interface tube, 33 buffer bag, 34 buffer bag lower liquid level sensor, 35 buffer bag upper liquid level sensor, 36 buffer bag reinfusion tube, 37 reinfusion peristaltic pump interface tube, 38 anticoagulated whole blood peristaltic pump interface tube, 39 anticoagulant bag, 40 anticoagulant bag outlet tube, 41 anticoagulant peristaltic pump interface tube, 42 human body puncture point connection tube 1, 43 puncture needle 1, 44 collection peristaltic pump interface tube, 45 collection selection valve, 46 anticoagulant selection valve, 47 puncture needle 2, 48 collection bag interface tube, 49 buffer transfer tube, 50 anticoagulant strobe tube 1, 51 anticoagulant strobe tube 2, 52 human body blood collection puncture point 1, 53 human body blood collection puncture point 2, 54 expansion joint, 55 expansion joint inlet inclined plane, 56 expansion joint outlet inclined plane, 57 centrifugal disc, 58 human body puncture point connection tube 2, 80 red blood cells, 81 white blood cells, 82 platelets, 83 plasma, 84 peripheral blood stem cells, 85 white blood cells other than peripheral blood stem cells, 90 tubular centrifuge tube wall, 91 tubular centrifuge tube bottom. Detailed implementation mode

[0046] Refer to Figure 1。In the following Specific Embodiment 1, Specific Embodiment 2, and Specific Embodiment 3 described below, a tubular continuous blood component separation device includes: a tubular centrifuge 1 with four fixed heads and an elastic untwisting tube bundle 10 connected to the tubular centrifuge 1. It is characterized in that: the anticoagulated whole blood inlet tube fixed head 6 of the tubular centrifuge 1 internally fixes the anticoagulated whole blood inlet centrifuge inner tube 12 and externally fixes the anticoagulated whole blood inflow tube 16; the component blood one outlet fixed head 7 of the tubular centrifuge 1 internally fixes the component blood one outlet centrifuge inner tube 13 and externally fixes the component blood one outflow tube 17; the component blood two outlet fixed head 8 of the tubular centrifuge 1 internally fixes the component blood two outlet centrifuge inner tube 14 and externally fixes the component blood two outflow tube 18; the red blood cell outlet tube fixed head 9 of the tubular centrifuge 1 internally fixes the red blood cell outlet centrifuge inner tube 15 and externally fixes the red blood cell outflow tube 19. The anticoagulated whole blood inlet centrifuge inner tube 12, the component blood one outlet centrifuge inner tube 13, the component blood two outlet centrifuge inner tube 14, and the red blood cell outlet centrifuge inner tube 15 are all hard tubes. The anticoagulated whole blood inlet centrifuge inner tube 12 is provided with an anticoagulated whole blood inlet end face 2, the component blood one outlet centrifuge inner tube 13 is provided with a component blood one outlet end face 3 parallel to the centrifugal rotation center line 20, the component blood two outlet centrifuge inner tube 14 is provided with a component blood two outlet end face 4 parallel to the centrifugal rotation center line 20, and the red blood cell outlet centrifuge inner tube 15 is provided with a red blood cell outlet end face 5 close to the bottom 91 of the tubular centrifuge tube. At any moment during the collection process, the red blood cell outlet end face 5, the anticoagulated whole blood inlet end face 2, the component blood two outlet end face 4, and the component blood one outlet end face 3 are all located on the same side of the centrifugal rotation center line 20, and the vertical distances from the centrifugal rotation center line 20 are, in order from largest to smallest, the red blood cell outlet end face 5, the anticoagulated whole blood inlet end face 2, the component blood two outlet end face 4, and the component blood one outlet end face 3. The anticoagulated whole blood inflow tube 16, the component blood one outflow tube 17, the component blood two outflow tube 18, and the red blood cell outflow tube 19 are all flexible tubes and converge into an elastic untwisting tube bundle 10 on the same side of the tubular centrifuge 1. The elastic untwisting tube bundle 10 is provided with an elastic untwisting tube bundle fixed head 11.

[0047] Refer to Figure 2 。The centrifuge motor 22 is connected to the centrifugal disk 57. The centrifugal disk 57 is provided with a untwisting bracket 23 fixed to the outer ring of the bearing. The centrifuge motor 22 is fixed on the fixed frame 24. The elastic untwisting tube bundle fixed head 11 on the elastic untwisting tube bundle 10 is fixed on the fixed frame 24. The tubular centrifuge 1 is inserted into the untwisting bracket 23 with bearings and forms a tight fit with the inner ring of the bearing. When the centrifuge motor 22 rotates, the untwisting bracket 23 on the centrifugal disk 57 drives the tubular centrifuge 1 to rotate along the centrifugal rotation center line 20. At the same time, due to the elastic stress existing in the elastic untwisting tube bundle 10, the whole tubular centrifuge 1 is driven to rotate and untwist along the untwisting rotation center line 21, so that the device can continuously rotate and centrifuge without knotting.

[0048] Specific Embodiment 1: Single-needle and single-apheresis of platelets.

[0049] Refer to Figure 3 . The anticoagulated whole blood inflow tube 16 is directly connected to the anticoagulated whole blood peristaltic pump interface tube 38 and is clamped on the anticoagulated whole blood peristaltic pump 27. The component blood first outflow tube 17 is directly connected to the control peristaltic pump interface tube 32 and is clamped on the control peristaltic pump 29. The control peristaltic pump interface tube 32 is connected to a buffer bag 33 provided with a buffer bag lower liquid level sensor 34 and a buffer bag upper liquid level sensor 35, and the connection interface is not lower than the buffer bag upper liquid level sensor 35. The component blood second outflow tube 18 is directly connected to the collection peristaltic pump interface tube 44 and is clamped on the collection peristaltic pump 30. The red blood cell outflow tube 19 is connected to the buffer bag 33, and the horizontal thickness of the connection interface is not lower than the buffer bag upper liquid level sensor 35. The anticoagulant bag outlet tube 40 is directly connected to the anticoagulant peristaltic pump interface tube 41 and is clamped on the anticoagulant peristaltic pump 26. The buffer bag return tube 36 connected to the bottom of the buffer bag 33 is connected to the return peristaltic pump interface tube 37 and is clamped on the return peristaltic pump 28. A component blood sensor 25 is provided on the component blood second outflow tube 18. The anticoagulant peristaltic pump interface tube 41, the anticoagulated whole blood peristaltic pump interface tube 38, and the return peristaltic pump interface tube 37 are all connected to the human body puncture point connection tube 1 42. The human body puncture point connection tube 1 42 is connected to the puncture needle 1 43. The collection peristaltic pump interface tube 44 is connected to the collection finished product bag 31.

[0050] Refer to Figure 4 . Puncture the puncture needle 1 43 into the human body blood collection puncture point 1 52. The anticoagulant peristaltic pump 26 rotates forward to make the anticoagulant in the anticoagulant bag 39 pass through the anticoagulant bag outlet tube 40 and the anticoagulant peristaltic pump interface tube 41 into the human body puncture point connection tube 1 42 in sequence. The return peristaltic pump 28 rotates forward at a flow rate greater than that of the anticoagulant peristaltic pump 26 to make the whole blood pass through the puncture needle 1 43, the human body puncture point connection tube 1 42, the return peristaltic pump interface tube 37, and the buffer bag return tube 36 in sequence and mix with the anticoagulant to form anticoagulated whole blood and enter the buffer bag 33 until the liquid level of the anticoagulated whole blood reaches the buffer bag lower liquid level sensor 34, then stop the rotation of the anticoagulant peristaltic pump 26 and the return peristaltic pump 28, and the air in the pipeline can be safely emptied so that no air can enter the human body during return.

[0051] Refer to Figure 5。The tubular centrifuge 1 rotates along the centrifugal rotation center line 20. The anticoagulant peristaltic pump 26 rotates forward to make the anticoagulant in the anticoagulant bag 39 pass through the anticoagulant bag outlet pipe 40 and the anticoagulant peristaltic pump interface pipe 41 in sequence and enter the first human puncture point connecting pipe 42. The anticoagulated whole blood peristaltic pump 27 rotates forward at a flow rate greater than that of the anticoagulant peristaltic pump 26 to make the anticoagulated whole blood pass through the first human puncture point connecting pipe 42, the anticoagulated whole blood inflow pipe 16, and the anticoagulated whole blood inlet centrifuge inner pipe 12 in sequence and enter the tubular centrifuge 1 from the anticoagulated whole blood inlet end face 2. Due to the action of centrifugal force and different densities in the tubular centrifuge 1, the anticoagulated whole blood is stratified into red blood cells 80, white blood cells 81, platelets 82, and plasma 83 from far to near the centrifugal rotation center line 20. At the same time, control the peristaltic pump 29 and the collection peristaltic pump 30 to rotate forward simultaneously at a flow rate such that the flow rate of the collection peristaltic pump 30 plus the flow rate of the control peristaltic pump 29 is less than the flow rate of the anticoagulated whole blood peristaltic pump 27, and continuously extrude the stratified red blood cells 80 from the red blood cell outlet end face 5, the red blood cell outlet centrifuge inner pipe 15, and the red blood cell outflow pipe 19 into the buffer bag 33. Under the condition that the flow rate of the collection peristaltic pump 30 plus the flow rate of the control peristaltic pump 29 is less than the flow rate of the anticoagulated whole blood peristaltic pump 27 and rotates forward, when the flow rate of the control peristaltic pump 29 is greater than the flow rate of the plasma separated from the anticoagulated whole blood flowing into the tubular centrifuge 1, the stratification interface of all cells moves towards the direction close to the centrifugal rotation center line 20, and when the flow rate of the control peristaltic pump 29 is less than the flow rate of the plasma separated from the anticoagulated whole blood flowing into the tubular centrifuge 1, the stratification interface of all cells moves towards the direction away from the centrifugal rotation center line 20. Control the platelets 82 to be located at the second component blood outlet end face 4 according to the feedback signal of the component blood sensor 25, and continuously collect the platelets 82 into the collection finished product bag 31.

[0052] Refer to Figure 6 。Keep the tubular centrifuge 1 rotating along the centrifugal rotation center line 20. When the liquid level in the buffer bag 33 reaches the upper liquid level sensor 35 of the buffer bag, the reinfusion peristaltic pump 28 rotates in reverse at a flow rate greater than that of the anticoagulated whole blood peristaltic pump 27 to reinfuse the liquid in the buffer bag 33 into the human body until the liquid level in the buffer bag 33 reaches the lower liquid level sensor 34 of the buffer bag, and then stop the reverse rotation of the reinfusion peristaltic pump 28 to complete the reinfusion during the collection process.

[0053] Refer to Figure 7 。When the collection is completed, keep the tubular centrifuge 1 rotating along the centrifugal rotation center line 20. Control the peristaltic pump 29 to rotate in reverse to fill the air in the buffer bag 33 into the tubular centrifuge 1, so that each component blood in the tubular centrifuge 1 is extruded into the buffer bag 33 through the red blood cell outflow pipe 19 and is reinfused through the reinfusion peristaltic pump 28. Since the red blood cell outlet end face 5 is close to the bottom 91 of the tubular centrifuge tube, only a small amount of red blood cells remain in the tubular centrifuge 1 after the reinfusion, which will not cause adverse effects on the donor's body.

[0054] Refer to Figure 8 、Figure 9 Preferably, an expansion joint 54 with a gradually increasing inlet and a gradually decreasing outlet is added to the inner tube 14 of the centrifugal separator for the second outlet of component blood, which can further improve the separation purity of platelet apheresis. Other cells that occasionally enter the inner tube 14 of the centrifugal separator for the second outlet of component blood will reach the wall of the expansion joint 54 faster due to the centrifugal force perpendicular to the untwisting rotation center line 21, and since the platelet density is lower than that of all other component blood cells and the flow rate has passed through a process of fast to slow and then to fast, they are not likely to enter the second outflow tube 18 of component blood. Also, because the centrifugal force perpendicular to the centrifugal rotation center line 20 acting on other component blood cells is much greater than the centrifugal force perpendicular to the untwisting rotation center line 21, they are thrown out of the expansion joint 54 from the inclined surface 55 of the expansion joint inlet and reach its stratification area, without causing the accumulation of other component blood cells in the expansion joint 54 and thus avoiding the loss of important cells of the donor.

[0055] Specific Embodiment 2: Single-needle apheresis of clinical plasma.

[0056] Refer to Figure 10 The anticoagulated whole blood inflow tube 16 is directly connected to and clamped on the anticoagulated whole blood peristaltic pump interface tube 38 and the anticoagulated whole blood peristaltic pump 27. The first outflow tube 17 of component blood is directly connected to and clamped on the collection peristaltic pump interface tube 44 and the collection peristaltic pump 30. The control peristaltic pump interface tube 32 is connected to a buffer bag 33 provided with a lower liquid level sensor 34 and an upper liquid level sensor 35 of the buffer bag, and the connection interface is not lower than the upper liquid level sensor 35 of the buffer bag. The second outflow tube 18 of component blood is directly connected to and clamped on the control peristaltic pump interface tube 32 and the control peristaltic pump 29. The red blood cell outflow tube 19 is connected to the buffer bag 33, and the horizontal thickness of the connection interface is not lower than the upper liquid level sensor 35 of the buffer bag. The anticoagulant bag outlet tube 40 is directly connected to and clamped on the anticoagulant peristaltic pump interface tube 41 and the anticoagulant peristaltic pump 26. The buffer bag return tube 36 connected to the bottom of the buffer bag 33 is connected to and clamped on the return peristaltic pump interface tube 37 and the return peristaltic pump 28. A component blood sensor 25 is provided on the second outflow tube 18 of component blood. The anticoagulant peristaltic pump interface tube 41, the anticoagulated whole blood peristaltic pump interface tube 38, and the return peristaltic pump interface tube 37 are all connected to the human body puncture point connection tube 1 42. The human body puncture point connection tube 1 42 is connected to the puncture needle 1 43. The collection peristaltic pump interface tube 44 is connected to the collection finished product bag 31.

[0057] Refer to Figure 11Insert the puncture needle 1 - 43 into the human blood collection puncture point 1 - 52. The anticoagulant peristaltic pump 26 rotates forward, causing the anticoagulant in the anticoagulant bag 39 to pass through the anticoagulant bag outlet tube 40 and the anticoagulant peristaltic pump interface tube 41 in sequence and enter the human puncture point connecting tube 1 - 42. The blood transfusion peristaltic pump 28 rotates forward at a flow rate greater than that of the anticoagulant peristaltic pump 26, causing the whole blood to pass through the puncture needle 1 - 43, the human puncture point connecting tube 1 - 42, the blood transfusion peristaltic pump interface tube 37, and the buffer bag blood transfusion tube 36 in sequence and mix with the anticoagulant to form anticoagulated whole blood, which enters the buffer bag 33 until the liquid level of the anticoagulated whole blood reaches the lower liquid level sensor 34 of the buffer bag. Then, stop the rotation of the anticoagulant peristaltic pump 26 and the blood transfusion peristaltic pump 28. It is possible to safely evacuate the air in the pipeline, making it impossible for air to enter the human body during blood transfusion.

[0058] Refer to Figure 12 The tubular centrifuge 1 rotates along the centrifugal rotation center line 20. The anticoagulant peristaltic pump 26 rotates forward, causing the anticoagulant in the anticoagulant bag 39 to pass through the anticoagulant bag outlet tube 40 and the anticoagulant peristaltic pump interface tube 41 in sequence and enter the human puncture point connecting tube 1 - 42. The anticoagulated whole blood peristaltic pump 27 rotates forward at a flow rate greater than that of the anticoagulant peristaltic pump 26, causing the anticoagulated whole blood to pass through the human puncture point connecting tube 1 - 42, the anticoagulated whole blood inflow tube 16, and the anticoagulated whole blood inlet centrifuge inner tube 12 in sequence and enter the tubular centrifuge 1 from the anticoagulated whole blood inlet end face 2. Due to the action of centrifugal force and different densities in the tubular centrifuge 1, the anticoagulated whole blood is stratified into red blood cells 80, white blood cells 81, platelets 82, and plasma 83 from far to near the centrifugal rotation center line 20. At the same time, control the peristaltic pump 29 and the collection peristaltic pump 30 to rotate forward simultaneously at a flow rate such that the flow rate of the collection peristaltic pump 30 plus the flow rate of the control peristaltic pump 29 is less than the flow rate of the anticoagulated whole blood peristaltic pump 27, and continuously extrude the stratified red blood cells 80 from the red blood cell outlet end face 5, the red blood cell outlet centrifuge inner tube 15, and the red blood cell outflow tube 19 into the buffer bag 33. Under the condition that the flow rate of the collection peristaltic pump 30 plus the flow rate of the control peristaltic pump 29 is less than the flow rate of the anticoagulated whole blood peristaltic pump 27 and rotates forward, when the flow rate of the collection peristaltic pump 30 is greater than the flow rate of the plasma separated from the anticoagulated whole blood flowing into the tubular centrifuge 1, the stratification interface of all cells moves towards the direction close to the centrifugal rotation center line 20; when the flow rate of the collection peristaltic pump 30 is less than the flow rate of the plasma separated from the anticoagulated whole blood flowing into the tubular centrifuge 1, the stratification interface of all cells moves towards the direction away from the centrifugal rotation center line 20. Control the platelets 82 to be located on the left side of the component blood two outlet end face 4 according to the feedback signal of the component blood sensor 25, and continuously collect the plasma 83 into the collection finished product bag 31.

[0059] Refer to Figure 13Keep the tubular centrifuge 1 rotating along the centrifugal rotation center line 20. When the liquid level in the buffer bag 33 reaches the upper liquid level sensor 35 of the buffer bag, the back-transfusion peristaltic pump 28 reverses at a flow rate greater than that of the anticoagulated whole blood peristaltic pump 27 to back-transfuse the liquid in the buffer bag 33 into the human body until the liquid level in the buffer bag 33 reaches the lower liquid level sensor 34 of the buffer bag, and then stops the reverse rotation of the back-transfusion peristaltic pump 28 to complete the back-transfusion during the collection process.

[0060] Refer to Figure 14 After the collection is completed, stop the anticoagulant peristaltic pump 26, the anticoagulated whole blood peristaltic pump 27, and the collection peristaltic pump 30. Keep the tubular centrifuge 1 rotating along the centrifugal rotation center line 20, control the peristaltic pump 29 to reverse to inject the air in the buffer bag 33 into the tubular centrifuge 1, so that each component blood in the tubular centrifuge 1 is extruded through the red blood cell outflow tube 19 into the buffer bag 33 and is back-transfused through the back-transfusion peristaltic pump 28. Since the end face 5 of the red blood cell outlet is close to the bottom 91 of the tubular centrifuge tube, only a trace amount of red blood cells remain in the tubular centrifuge 1 after the back-transfusion, which will not cause adverse effects on the donor's body.

[0061] Specific Embodiment 3: Double-needle collection of peripheral blood stem cells.

[0062] Refer to Figure 15。The anticoagulated whole blood inflow tube 16 is directly connected to the human body puncture point connecting tube 1 and is clamped on the anticoagulated whole blood peristaltic pump 27. The component blood 1 outflow tube 17 is directly connected to the control peristaltic pump interface tube 32 and is clamped on the control peristaltic pump 29. The control peristaltic pump interface tube 32 is connected to the buffer bag 33 provided with a buffer bag lower liquid level sensor 34 and a buffer bag upper liquid level sensor 35, and the connection interface is not lower than the buffer bag upper liquid level sensor 35. The component blood 2 outflow tube 18 is directly connected to the collection peristaltic pump interface tube 44 and is clamped on the collection peristaltic pump 30. The red blood cell outflow tube 19 is connected to the buffer bag 33, and the horizontal thickness of the connection interface is not lower than the buffer bag upper liquid level sensor 35. The anticoagulant bag outlet tube 40 is directly connected to the anticoagulant peristaltic pump interface tube 41 and is clamped on the anticoagulant peristaltic pump 26. The buffer bag return tube 36 connected to the bottom of the buffer bag 33 is connected to the return peristaltic pump interface tube 37 and is clamped on the return peristaltic pump 28. A component blood sensor 25 is provided on the component blood 2 outflow tube 18. The fixed end of the anticoagulant selection valve 46 is connected to the anticoagulant peristaltic pump interface tube 41. The two selected ends of the anticoagulant selection valve 46 are respectively connected to the anticoagulant selection tube 1 50 and the anticoagulant selection tube 2 51. The anticoagulant selection tube 1 50 is connected to the human body puncture point connecting tube 1 42. The anticoagulant selection tube 2 51 is connected to the human body puncture point connecting tube 2 58. The human body puncture point connecting tube 2 58 is connected to the return peristaltic pump interface tube 37. The fixed end of the collection selection valve 45 is connected to the collection peristaltic pump interface tube 44. The two selected ends of the collection selection valve 45 are respectively connected to the collection bag interface tube 48 and the buffer transfer tube 49. The collection bag interface tube 48 is connected to the collection finished product bag 31. The buffer transfer tube 49 is connected to the red blood cell outflow tube 19. The human body puncture point connecting tube 2 58 is connected to the puncture needle 2 47. The human body puncture point connecting tube 1 42 is connected to the human body blood collection puncture point 1 52.

[0063] Refer to Figure 16 。Puncture the puncture needle 1 43 into the human body blood collection puncture point 1 52, and puncture the puncture needle 2 47 into the human body blood collection puncture point 2 53. Control the anticoagulant selection valve 46 so that the anticoagulant peristaltic pump interface tube 41 only communicates with the anticoagulant selection tube 2 51. The anticoagulant peristaltic pump 26 rotates forward so that the anticoagulant in the anticoagulant bag 39 sequentially passes through the anticoagulant bag outlet tube 40, the anticoagulant peristaltic pump interface tube 41, and the anticoagulant selection tube 2 51 and enters the human body puncture point connecting tube 2 58. The return peristaltic pump 28 rotates forward at a flow rate greater than that of the anticoagulant peristaltic pump 26 so that the whole blood sequentially passes through the puncture needle 2 47, the human body puncture point connecting tube 2 58, the return peristaltic pump interface tube 37, and the buffer bag return tube 36 and is mixed with the anticoagulant to form anticoagulated whole blood and enter the buffer bag 33 until the liquid level of the anticoagulated whole blood reaches the buffer bag lower liquid level sensor 34, then stop the rotation of the anticoagulant peristaltic pump 26 and the return peristaltic pump 28, which can safely empty the air in the pipeline so that no air can enter the human body during return.

[0064] Refer to Figure 17。The tubular centrifuge 1 rotates along the centrifugal rotation center line 20. The anticoagulant selection valve 46 is controlled to make the anticoagulant peristaltic pump interface tube 41 only communicate with the first anticoagulant selection tube 50. The anticoagulant peristaltic pump 26 rotates forward, and the anticoagulant in the anticoagulant bag 39 sequentially passes through the anticoagulant bag outlet tube 40, the anticoagulant peristaltic pump interface tube 41, and the first anticoagulant selection tube 50 and enters the first human puncture point connection tube 42. The anticoagulated whole blood peristaltic pump 27 rotates forward at a flow rate greater than that of the anticoagulant peristaltic pump 26, and the anticoagulated whole blood sequentially passes through the first human puncture point connection tube 42, the anticoagulated whole blood inflow tube 16, and the anticoagulated whole blood inlet centrifuge inner tube 12 and enters the tubular centrifuge 1 from the anticoagulated whole blood inlet end face 2. Due to the action of centrifugal force and different densities in the tubular centrifuge 1, the anticoagulated whole blood is stratified into red blood cells 80, peripheral blood stem cells 84, white blood cells 85 other than peripheral blood stem cells, platelets 82, and plasma 83 from far to near the centrifugal rotation center line 20. At the same time, the control peristaltic pump 29 and the collection peristaltic pump 30 are controlled to rotate forward simultaneously at a flow rate such that the flow rate of the collection peristaltic pump 30 plus the flow rate of the control peristaltic pump 29 is less than the flow rate of the anticoagulated whole blood peristaltic pump 27, and the stratified red blood cells 80 are continuously extruded into the buffer bag 33 in sequence from the red blood cell outlet end face 5, the red blood cell outlet centrifuge inner tube 15, and the red blood cell outflow tube 19. The collection selection valve 45 is controlled to make the collection peristaltic pump interface tube 44 only communicate with the buffer transfer tube 49, and the buffer transfer tube 49 communicates with the red blood cell outflow tube 19. Under the condition that the flow rate of the collection peristaltic pump 30 plus the flow rate of the control peristaltic pump 29 is less than the flow rate of the anticoagulated whole blood peristaltic pump 27 and rotates forward, when the flow rate of the collection peristaltic pump 30 is greater than the flow rate of the plasma separated from the anticoagulated whole blood flowing into the tubular centrifuge 1, the stratification interface of all cells moves towards the direction close to the centrifugal rotation center line 20, and when the flow rate of the collection peristaltic pump 30 is less than the flow rate of the plasma separated from the anticoagulated whole blood flowing into the tubular centrifuge 1, the stratification interface of all cells moves towards the direction away from the centrifugal rotation center line 20. According to the feedback signal of the component blood sensor 25, the peripheral blood stem cells 84 are controlled to be located on the left side of the second component blood outlet end face 4, so as to stack the peripheral blood stem cells 84 in the tubular centrifuge 1.

[0065] Refer to Figure 18 。Keep the tubular centrifuge 1 rotating along the centrifugal rotation center line 20. When the liquid level in the buffer bag 33 reaches the upper liquid level sensor 35 of the buffer bag, the reinfusion peristaltic pump 28 rotates in reverse to reinfuse the liquid in the buffer bag 33 into the human body until the liquid level in the buffer bag 33 reaches the lower liquid level sensor 34 of the buffer bag, and then the reverse rotation of the reinfusion peristaltic pump 28 stops, completing the reinfusion during the collection process.

[0066] Refer to Figure 19Keep the tubular centrifuge 1 rotating along the centrifugal rotation center line 20. When the number of peripheral blood stem cells 84 in the tubular centrifuge 1 reaches a certain amount, under the condition that the flow rate of the collection peristaltic pump 30 plus the flow rate of the control peristaltic pump 29 is less than the forward rotation flow rate of the anticoagulated whole blood peristaltic pump 27, continuously increase the flow rate of the control peristaltic pump 29 to move the component blood stratification interface towards the centrifugal rotation center line 20. When the component blood sensor 25 detects that the component blood in the current tube is peripheral blood stem cells 84, control the collection selection valve 45 to make the collection peristaltic pump interface tube 44 only communicate with the collection bag interface tube 48, and collect the peripheral blood stem cells 84 into the collection finished product bag 31.

[0067] Refer to Figure 20 After the collection is completed, stop the anticoagulant peristaltic pump 26, the anticoagulated whole blood peristaltic pump 27, and the collection peristaltic pump 30. Keep the tubular centrifuge 1 rotating along the centrifugal rotation center line 20, control the peristaltic pump 29 to rotate in reverse to fill the air in the buffer bag 33 into the tubular centrifuge 1, so that each component blood in the tubular centrifuge 1 is extruded into the buffer bag 33 through the red blood cell outflow tube 19 and is transfused back through the reinfusion peristaltic pump 28. Since the red blood cell outlet end face 5 is close to the bottom 91 of the tubular centrifuge tube, only a small amount of red blood cells remain in the tubular centrifuge 1 after the reinfusion is completed, which will not cause adverse effects on the donor's body.

[0068] The above is a preferred embodiment of the present invention. It should be noted that the above embodiments are used to illustrate the present invention. However, the present invention is not limited thereto, and those skilled in the art can design alternative embodiments without departing from the scope of the appended claims. For those skilled in the art, various corresponding changes and deformations can be made according to the technical solutions and concepts described above, and all these changes and deformations should fall within the protection scope of the claims of the present invention.

Claims

1. A tube-type continuous blood component separation device, characterized in that: Comprising a tubular centrifuge (1) provided with four fixed heads and an elastic torsion-relieving tube bundle (10) connected to the tubular centrifuge (1), the anticoagulated whole blood inlet tube fixed head (6) of the tubular centrifuge (1) internally fixes the anticoagulated whole blood inlet centrifuge inner tube (12) and externally fixes the anticoagulated whole blood inflow tube (16), the component blood one outlet fixed head (7) of the tubular centrifuge (1) internally fixes the component blood one outlet centrifuge inner tube (13) and externally fixes the component blood one outflow tube (17), the component blood two outlet fixed head (8) of the tubular centrifuge (1) internally fixes the component blood two outlet centrifuge inner tube (14) and externally fixes the component blood two outflow tube (18), the red blood cell outlet tube fixed head (9) of the tubular centrifuge (1) internally fixes the red blood cell outlet centrifuge inner tube (15) and externally fixes the red blood cell outflow tube (19), the anticoagulated whole blood inlet centrifuge inner tube (12), the component blood one outlet centrifuge inner tube (13), the component blood two outlet centrifuge inner tube (14), and the red blood cell outlet centrifuge inner tube (15) are all rigid tubes, the anticoagulated whole blood inlet centrifuge inner tube (12) is provided with an anticoagulated whole blood inlet end face (2), the component blood one outlet centrifuge inner tube (13) is provided with an outlet end face (3), the component blood two outlet centrifuge inner tube (14) is provided with a component blood two outlet end face (4), the red blood cell outlet centrifuge inner tube (15) is provided with a red blood cell outlet end face (5) close to the bottom of the tubular centrifuge tube (91), the red blood cell outlet end face (5), the anticoagulated whole blood inlet end face (2), the component blood two outlet end face (4), and the component blood one outlet end face (3) are all on the same side of the centrifugal rotation center line (20) at any moment during the collection process and the vertical distances from the centrifugal rotation center line (20) are in descending order as the red blood cell outlet end face (5), the anticoagulated whole blood inlet end face (2), the component blood two outlet end face (4), and the component blood one outlet end face (3), the anticoagulated whole blood inflow tube (16), the component blood one outflow tube (17), the component blood two outflow tube (18), and the red blood cell outflow tube (19) are all flexible tubes and converge into an elastic torsion-relieving tube bundle (10) on the same side of the tubular centrifuge (1), and the elastic torsion-relieving tube bundle (10) is provided with an elastic torsion-relieving tube bundle fixed head (11). The centrifuge motor (22) is connected to a centrifugal disc, the centrifugal disc is provided with a torsion-relieving bracket (23) fixed to the outer ring of the bearing, the centrifuge motor (22) is fixed on a fixed frame (24), the elastic torsion-relieving tube bundle fixed head (11) on the elastic torsion-relieving tube bundle (10) is fixed on the fixed frame (24), and the tubular centrifuge (1) is inserted into the torsion-relieving bracket (23) with a bearing and forms a tight fit with the inner ring of the bearing.

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