Whole blood collection separator and collection and separation method thereof

Abstract

The invention relates to the technical field of blood collection and separation, in particular to a whole blood collection separator and a collection and separation method thereof.The whole blood collection separator comprises a blood collection pipeline, a red blood cell preserving fluid conveying branch, a first branch, a red blood cell collection branch and a separation branch which are connected in a through mode; the blood collection pipeline and the red blood cell collection branch are converged to be connected with one end of the first branch, and the other end of the first branch is connected with the cell preservation liquid conveying branch and the separation branch respectively; the erythrocyte preservation liquid conveying branch is connected with the second peristaltic pump, the separation branch is connected with the first peristaltic pump and comprises a separation cup and a collection bag, two separation cup connectors are formed in the top of the separation cup, and the separation cup connector on one side and the erythrocyte preservation liquid conveying branch are converged to the first branch through a guide pipe connected with the first peristaltic pump; and the separation cup connector on the other side is connected with a collection bag through a guide pipe. According to the invention, separation and extraction of blood components can be synchronously completed during collection of whole blood, and secondary treatment is not needed.

Description

Technical Field

[0001] The present application relates to the technical field of blood collection and separation, and in particular to a whole blood collection and separation device and a collection and separation method thereof. Background Art

[0002] In the medical field, blood, as a vital medical resource, plays an irreplaceable role in saving patients' lives. When patients require blood transfusions due to blood loss, anemia, or other reasons, accurately and efficiently obtaining the appropriate blood components is crucial for treatment effectiveness and patient safety. Clinically, red blood cells are primarily transfused because they carry the important physiological function of transporting oxygen and carbon dioxide, while plasma and buffy coat (containing components such as white blood cells) are generally not required in these transfusion scenarios. Therefore, blood collection requires specific processing to obtain high-purity red blood cells.

[0003] In the prior art, after a blood collection station collects blood, it needs to process the collected blood again to obtain the required red blood cells. The processing flow is as follows: First, a leukocyte removal filter is used to filter the blood in the blood bag to remove white blood cells to reduce the risk of adverse reactions to blood transfusion; the blood bag with the leukocytes removed is then placed in a large centrifuge for centrifugal stratification, allowing the blood to naturally separate into an upper layer of plasma, a middle layer of buffy coat, and a lower layer of red blood cells; after stratification, the upper opening of the blood bag needs to be opened manually, and the upper layer of plasma is slowly discharged by squeezing the lower layer of red blood cells, ultimately retaining the red blood cell components in the bag, and finally the bag opening is heat-sealed. However, the above processing process has significant drawbacks: the manual squeezing operation requires extremely high proficiency, and the slightest carelessness will cause the already stratified components to mix again, resulting in blood waste; at the same time, the entire process relies on manual intervention, which is not only time-consuming and labor-intensive, but also prolongs the cycle from blood collection to clinical availability, affecting blood transfusion efficiency; in addition, multiple manual operations also increase the potential risk of blood contamination, posing a threat to blood quality and safety.

[0004] Therefore, there is an urgent need to develop a technology that can simultaneously complete the separation of red blood cells, plasma and buffy coat during the blood collection process to overcome the above-mentioned defects of the existing technology. Summary of the Invention

[0005] The purpose of the present application is to provide a whole blood collection and separation device and a collection and separation method thereof, so as to solve the problems existing in the prior art such as the inability to complete the separation of various blood components during the collection process and the need for manual secondary processing to obtain red blood cells.

[0006] The embodiments of the present application can be implemented through the following technical solutions: A whole blood collection and separation device comprises a blood collection tube circuit, a red blood cell preservation solution delivery branch, a first branch, a red blood cell collection branch, and a separation branch connected therethrough, wherein the blood collection tube circuit and each branch are provided with a liquid stop structure, wherein the blood collection tube circuit and the red blood cell collection branch converge to be connected to one end of the first branch, and the other end of the first branch is respectively connected to the cell preservation solution delivery branch and the separation branch; The cell preservation fluid delivery branch is connected to the second peristaltic pump, and the separation branch is connected to the first peristaltic pump. The separation branch includes a separation cup and a collection bag. Two separation cup interfaces are provided on the top of the separation cup. The separation cup interface on one side is connected to the red blood cell preservation fluid delivery branch through a catheter connected to the first peristaltic pump and is converged to the first branch. The separation cup interface on the other side is connected to the collection bag through a catheter.

[0007] Furthermore, one of the blood collection tube circuit and the red blood cell collection branch is selectively connected, and the red blood cell collection branch first collects the concentrated red blood cells overflowing from the separation cup under the reverse action of the first peristaltic pump. After collecting a preset amount of concentrated red blood cells, if the separation cup is still not full after completing the collection of all the whole blood in the blood collection tube circuit, the first peristaltic pump is used to continuously transport the concentrated red blood cells to the separation cup until the separation cup is full and overflows with red blood cells, then the collection of concentrated red blood cells is stopped, and the reverse action of the first peristaltic pump is used again to collect the concentrated red blood cells in the separation cup through the red blood cell collection branch.

[0008] Furthermore, the blood collection tube circuit is a catheter connected to a whole blood bag or a combined branch of a blood collection branch and a blood preservation solution delivery branch, and the blood preservation solution delivery branch is connected to a third peristaltic pump.

[0009] Furthermore, the red blood cell collection branch includes a red blood cell bag, a catheter, and a fluid-stopping clamp.

[0010] Furthermore, the blood collection tube circuit and the red blood cell collection branch circuit are both connected to blood valves at their interfaces adjacent to the first branch circuit, and the blood valve serves as a liquid-stopping structure for selectively conducting one of the blood collection tube circuit and the red blood cell collection branch circuit.

[0011] Furthermore, the red blood cell bag is provided with an interface connected to the leukoreduction kit, the interface is connected to one end of the catheter through a foldable plug, and the other end of the catheter is connected to a flow regulator, a leukoreduction filter, a second connector, and a leukoreduction red blood cell bag through a first connector.

[0012] Furthermore, there are multiple collection bags, which are plasma bags, transfer bags, and buffy coat collection bags, respectively. An air detector is provided on the catheter connected to the first peristaltic pump, and the air detector is provided between the first peristaltic pump and the separation cup.

[0013] Furthermore, a red overflow sensor is provided on the catheter connecting the separation cup interface and the collection bag.

[0014] Furthermore, the separation cup is composed of a cup body, a cup cover, an upper cover, a stationary head, and a separation cup interface. A sealing bowl is provided in the stationary head, and the top is connected to the separation cup interfaces on both sides through a central tube. The central tube extends downward to pass through the cup core in the cup body. Under the action of centrifugal force, a separation cavity is formed between the outer wall of the cup core and the inner wall of the cup body. The volume of the separation cavity is the dynamic capacity, and the dynamic capacity of the separation cup is 75ml-160ml.

[0015] Furthermore, the diameter of the cup core is 44.5 mm, the height of the cup core is 24.5 mm-45.5 mm, the diameter of the cup body is 83.4 mm, and the height of the cup body is 48.5 mm-69.5 mm.

[0016] Furthermore, a pressure monitoring branch is connected between the two ends of the first branch via the first connecting piece, and a clip and a pressure monitor connector are provided on the pressure monitoring branch.

[0017] The present application also provides a collection and separation method of a whole blood collection separator, which uses the whole blood collection separator as described, including a first-stage collection and separation process. The first-stage collection and separation process is that when the red blood cell collection branch is cut off, the anticoagulated whole blood in the blood collection tube circuit is transported to the separation cup, and is separated under the action of centrifugal force in the separation cup. The separated plasma and white film layer are selectively collected in the corresponding collection bags one by one until the separation cup is full of red blood cells. The blood collection action of the blood collection tube circuit and the collection action of the collection bag are stopped, and the red blood cell preservation fluid delivery branch is kept in a closed state. The pipeline where the plasma bag is located and the red blood cell collection branch are connected, the first peristaltic pump is reversed, and the air in the plasma bag is used to return the red blood cells in the separation cup and collect them in the red blood cell bag. At this time, the collected red blood cells are concentrated red blood cells.

[0018] Furthermore, it also includes a second stage collection and separation process, the specific steps are as follows: S21, after the set amount of whole blood is collected, if the separation cup is not detected to be full within a specified time after blood collection is stopped, the blood valve closes the blood collection tube line. After blood collection is stopped, the red blood cell stop structure is opened, and concentrated red blood cells are added to the separation cup from the red blood cell bag under the positive drive of the first peristaltic pump. The concentrated red blood cells from the red blood cell bag are separated and replaced with plasma in the separation cup. S22, opening the liquid stop structure of the pipeline where the plasma bag is located, and collecting the plasma displaced from the separation cup into the plasma bag; S23, during the collection process, when the red blood cell overflow sensor detects red blood cells in the catheter connected to the outlet of the separation cup, the stopper of the line where the plasma bag is located is closed, and the stopper of the line where the buffy coat layer collection bag is located is opened, and the buffy coat layer overflowing from the separation cup is collected in the buffy coat layer collection bag. When the buffy coat layer in the buffy coat layer collection bag reaches a specified collection volume, the stopper of the line where the buffy coat layer collection bag is located is closed, and replenishment is stopped. At this point, the separation cup is full of concentrated red blood cells. S24, after stopping the red blood cell supplementation, open the liquid stop structure of the pipeline where the plasma bag is located, keep the blood valve to close the blood collection tube pipeline, reverse the first peristaltic pump, and collect the concentrated red blood cells in the full cup of the separation cup. At this time, open the liquid stop structure of the pipeline where the second peristaltic pump is located, and the second peristaltic pump reverses. The red blood cell preservation fluid delivery branch transports the red blood cell preservation fluid connected to the pipeline downward, and the red blood cell preservation fluid and red blood cells merge in proportion at the blood transfusion tee to form suspended red blood cells, which are collected in the red blood cell bag.

[0019] Furthermore, when the red blood cell collection branch is not connected to the leukoreduction kit, a third stage collection and separation process is also included, and the specific steps are as follows: S31, connecting one interface of the red blood cell bag to the relevant pipeline of the leukocyte removal filter kit through a sterile connection method, so that the red blood cell bag is connected to the leukocyte removal bag through the leukocyte removal filter; S32, the red blood cell bag is hung, and the suspended red blood cells in the red blood cell bag flow into the leukocyte-reduced red blood cell bag through the leukocyte removal filter under the action of gravity. The leukocyte removal filter is used to remove the leukocytes present in the suspended red blood cells in the red blood cell bag, so that the red blood cells in the leukocyte-reduced red blood cell bag are leukocyte-reduced suspended red blood cells.

[0020] Furthermore, when the red blood cell collection branch is connected to a leukoreduction kit, a third stage collection and separation process is also included, and the specific steps are as follows: S31, heat-sealing the catheter of the red blood cell collection branch to separate it from the whole blood collection separator, while retaining the red blood cell bag and leukocyte removal kit; S32, the red blood cell bag is hung, and the suspended red blood cells in the red blood cell bag flow into the leukocyte-reduced red blood cell bag through the leukocyte removal filter under the action of gravity. The leukocyte removal filter is used to remove the leukocytes present in the suspended red blood cells in the red blood cell bag, so that the red blood cells in the leukocyte-reduced red blood cell bag are leukocyte-reduced suspended red blood cells.

[0021] The whole blood collection and separation device and the collection and separation method provided in the embodiments of the present application have at least the following beneficial effects: The present application uses a through-connected blood collection tube line, a red blood cell collection branch, a separation branch and a matching first peristaltic pump, a separation cup and other structures, and arranges and designs the connection directions of each pipeline branch, so that whole blood can directly enter the separation cup for separation operation during the collection process. The double-interface design on the top of the separation cup cooperates with the pipeline connection to transport the separated components to each collection bag through the corresponding pipeline in real time, and transport the red blood cells to the red blood cell bag connected to the red blood cell collection branch. The collection of each component blood can be completed during the whole blood collection process, especially the separation and extraction of red blood cells can be completed.

[0022] On this basis, the present application relies on the synergistic effect of the red blood cell collection branch and the first peristaltic pump, and can automatically complete the collection of concentrated red blood cells through the forward and reverse control of the pump: it can directly collect the concentrated red blood cells overflowing from the separation cup, and when the separation cup is not full, it can continuously transport the concentrated red blood cells until the cup is full and then collect them. It can meet the separation requirements of any quantitative whole blood collection and ensure that all the collected whole blood is separated and extracted. At the same time, the red blood cell preservation fluid delivery branch can synchronously complete the addition of preservation fluid, and finally obtain qualified red blood cell products directly through the collection bag, without the need for manual intervention to transfer and process blood components throughout the process. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 The blood collection line is a whole blood collection separator equipped with a venipuncture device; Figure 2 A whole blood collection separator for aseptic connection of blood collection tubes; Figure 3 Connect the red blood cell collection branch to a whole blood collection separator with a leukoreduction kit; Figure 4 A side cross-sectional view of the separation cup in this application; Figure 5 This is an overall schematic diagram of the separation cup in this application.

[0024] Numbers in the figure 1 - Venipuncture device; 2 - First connector; 3 - Stop clamp; 4 - Sample bag; 5 - Needle holder for Ancai collection; 6 - Catheter; 7 - Blood transfusion port puncture device; 8 - Liquid filter; 9 - Limiting card; 11 - Clip; 12 - Pressure monitor connector; 13 - Separation cup interface; 14 - Separation cup; 17 - Red blood cell bag; 18 - Plasma bag; 19 - Transfer bag; 20 - Buffy coat collection bag; 21 - Foldable stopper; 22 - Flow regulator; 23 - White blood cell removal filter; 24 - Second connector; 25 - White blood cell removal bag; 26 - First peristaltic pump; 27 - Second peristaltic pump; 28 - Third peristaltic pump; 29 - Blood valve; 1.0-blood collection branch; 1.1-blood preservation solution delivery branch; 1.2-red blood cell preservation solution delivery branch; 1.4-first branch; 1.5-red blood cell collection branch; 1.6-separation branch; DETAILED DESCRIPTION Hereinafter, the present application will be further described based on preferred embodiments with reference to the accompanying drawings.

[0025] In addition, various components in the drawings are enlarged or reduced in size for ease of understanding, but this is not intended to limit the scope of protection of this application.

[0026] Words importing the singular include the plural and vice versa.

[0027] In the description of the embodiments of the present application, it should be noted that if the terms "upper", "lower", "inner", "outer" and the like indicate an orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or are the orientation or positional relationship in which the products of the embodiments of the present application are usually placed when in use, they are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application. In addition, in the description of the present application, in order to distinguish different units, words such as first and second are used in this specification, but these are not limited by the order of manufacture, nor can they be understood as indicating or implying relative importance. Their names may be different in the detailed description and claims of the present application.

[0028] The vocabulary in this specification is used to illustrate the embodiments of the present application, but is not intended to limit the present application. It should also be noted that, unless otherwise clearly specified and limited, the terms "disposed", "connected", and "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, a direct connection, an indirect connection through an intermediate medium, or a communication between the two components. For those skilled in the art, the specific meanings of the above terms in this application can be specifically understood.

[0029] like Figures 1 to 3As shown, a whole blood collection and separation device includes a blood collection tube circuit, a red blood cell preservation solution delivery branch 1.2, a first branch 1.4, a red blood cell collection branch 1.5 and a separation branch 1.6. The blood collection tube circuit and each branch are connected to each other through a plurality of first connectors 2, wherein the blood collection tube circuit and the red blood cell collection branch 1.5 are connected to one end of the first branch 1.4 through the first connector 2, and the other end of the first branch 1.4 is connected to the cell preservation solution delivery branch 1.2 and the separation branch 1.6 respectively through the first connector 2. .6 connection, the whole blood collection and separation device is connected to the whole blood collection and separation equipment, the fully automatic whole blood collection and separation equipment is equipped with a peristaltic pump, a centrifuge, a detector, a blood valve 29, a measuring scale, and an air detector, wherein the peristaltic pump includes a first peristaltic pump 26, a second peristaltic pump 27, and a third peristaltic pump 28, and the measuring scale includes a plasma scale and a whole blood scale. Under the driving action of each peristaltic pump, each pipeline and branch works in coordination with each other to complete the collection and separation needs of each pipeline. The fully automatic whole blood collection and separation equipment is the existing technology in this field, and the specific structure is not further limited here.

[0030] In some preferred embodiments, the first connecting member 2 is a tee.

[0031] In some preferred embodiments, the blood collection tube circuit and the red blood cell collection branch 1.5 are connected to the interface adjacent to the first branch 1.4 with a blood valve 29. The blood valve 29 is a liquid-stopping structure for conducting or cutting off the pipeline in which it is located.

[0032] In some preferred embodiments, the blood collection tube circuit is a catheter 6 connected to a whole blood bag or a combined branch of a blood collection branch 1.0 and a blood preservation fluid delivery branch 1.1. When the blood collection tube circuit is a combined branch, the blood collection branch 1.0 and the blood preservation fluid delivery branch 1.1 are respectively connected to the two branch interfaces of the first connector 2, and finally converge to the main interface of the first connector 2. The main interface of the first connector 2 is connected to a catheter 6, and anticoagulated whole blood formed by a mixture of whole blood collected by the blood collection branch 1.0 and blood preservation fluid delivered by the blood preservation fluid delivery branch 1.1 flows in the catheter 6 as the blood collection tube circuit.

[0033] In some preferred embodiments, the blood collection branch 1.0 includes a main branch and two branch roads, wherein the main branch is connected to a venous puncture device 1 and is connected to the other two branch roads through a first connecting piece 2, one of the branch roads is connected to the blood preservation liquid delivery branch 1.1 through the first connecting piece 2, and the other branch road is connected to a liquid stop clamp 3, a sample bag 4, and a collection needle holder 5. Preferably, the liquid stop clamp 3 can also be replaced with a blood valve 29, so that there is no need to manually adjust the conduction or cutoff of the pipeline in which it is located.

[0034] In some preferred embodiments, the blood preservation solution delivery branch 1.1 is connected to the third peristaltic pump 28, and the blood preservation solution delivery branch 1.1 includes a blood transfusion socket puncture device 7, a liquid medicine filter 8, and a limit card 9.

[0035] In the prior art, the above-mentioned blood collection tube circuit is directly connected to the separation branch 1.6. Unlike the prior art, the present application is further provided with a red blood cell collection branch 1.5. The blood collection tube circuit and the red blood cell collection branch 1.5 are converged to the main end of the first branch 1.4 through the two branch interfaces of the first connecting piece 2. The red blood cell collection branch 1.5 includes a red blood cell bag 17, a catheter 6, and a liquid stop clamp 3, which are used to collect or retransfuse red blood cells.

[0036] In some preferred embodiments, either the blood collection tube circuit or the red blood cell collection branch 1.5 is selectively connected, and the red blood cell collection branch 1.5 is used to first collect the concentrated red blood cells overflowing from the separation cup 14 under the reverse action of the first peristaltic pump 26. After a preset amount of concentrated red blood cells are collected, if the separation cup 14 is still not full after completing the collection of all whole blood in the blood collection tube circuit, the first peristaltic pump 26 is used to continuously transport concentrated red blood cells to the separation cup 14 through the forward action of the first peristaltic pump 26 until the separation cup 14 is full and overflows red blood cells, then the collection of concentrated red blood cells is stopped, and the reverse action of the first peristaltic pump 26 is used again to collect the concentrated red blood cells in the separation cup 14 through the red blood cell collection branch 1.5.

[0037] It should be noted that, in this application document, to facilitate a clear and accurate description of the relevant technical content, we have established the following reference standard for rotation direction: based on the perspective presented in Figure 1, clockwise rotation of the peristaltic pump is defined as forward rotation, and counterclockwise rotation is defined as reverse rotation. It is emphasized that this definition does not substantively limit the rotation direction of the peristaltic pump. Its core function is merely to serve as an auxiliary means for more clearly distinguishing the flow direction of the liquid in the peristaltic pump. Therefore, it should not be used as a limiting condition for the rotation direction of the peristaltic pump in the technical solution of this application. In some preferred embodiments, the red blood cell bag 17 is provided with an interface for connecting to the leukocyte removal kit. The interface is connected to one end of the catheter 6 via a frangible plug 21. The other end of the catheter 6 is connected to a flow regulator 22, a leukocyte removal filter 23, a second connector 24, and a leukocyte removal bag 25 via a first connector 2. The flow regulator 22, a leukocyte removal filter 23, a second connector 24, and a leukocyte removal bag 25 are used to pass the suspended red blood cells in the red blood cell bag 17 after separation through the leukocyte removal kit to completely remove the buffy coat layer therein. Preferably, the second connector 24 is a reducing two-way pipe.

[0038] In some preferred embodiments, the interface at the other end of the first branch 1.4 is connected to the red blood cell preservation solution delivery branch 1.2 and the separation branch 1.6 respectively through the first connecting member 2.

[0039] In some preferred embodiments, a pressure monitoring branch is further connected between the two ends of the first branch 1.4 via the first connecting piece 2. The pressure monitoring branch is provided with a clip 11 and a pressure monitor connector 12 for realizing real-time monitoring of the pressure in the pipeline and pipeline disconnection and pressure regulation control.

[0040] In some preferred embodiments, the cell preservation fluid delivery branch 1.2 is connected to the second peristaltic pump 27. The red blood cell preservation fluid delivery branch 1.2 includes a blood transfusion socket puncture device 7, a liquid medicine filter 8, and a limit card 9. The second peristaltic pump 27 is used to reverse and transport the red blood cell preservation fluid connected to the cell preservation fluid delivery branch 1.2 downward when the separation cup 14 is in the stage of full cup of concentrated red blood cells being transported to the red blood cell collection branch 1.5. The red blood cell preservation fluid and concentrated red blood cells are merged in proportion to form suspended red blood cells, which are collected in the red blood cell bag 17 of the red blood cell collection branch 1.5.

[0041] In some preferred embodiments, the liquid-stop clamp 3 and the blood valve 29 are both liquid-stop structures, used to conduct or cut off the flow of liquid in the pipelines where they are located.

[0042] In some preferred embodiments, the separation branch 1.6 is connected to the first peristaltic pump 26, and the separation branch 1.6 includes a separation cup 14 and multiple collection bags. Two separation cup interfaces 13 are provided on the top of the separation cup 14. The separation cup interface 13 on one side is connected to the red blood cell preservation fluid delivery branch 1.2 through a catheter 6 connected to the first peristaltic pump 26 and is converged to the first branch 1.4, and the separation cup interface 13 on the other side is connected to each collection bag through the catheter 6. Preferably, each collection bag is a plasma bag 18, a transfer bag 19, and a buffy coat collection bag 20.

[0043] In some preferred embodiments, an air detector is provided on the branch where the medium flow path in the plasma bag 18 is located. Preferably, an air detector is provided on the catheter 6 connected to the first peristaltic pump 26. The air detector is provided between the first peristaltic pump 26 and the separation cup 14 to monitor whether air flows into the pipeline.

[0044] In some preferred embodiments, the red blood cell preservation solution delivery branch 1.2 and the blood preservation solution delivery branch 1.1 are both provided with air detectors, which are conventional designs in the art and will not be further described here.

[0045] In some preferred embodiments, a red blood cell overflow sensor is provided on the conduit 6 connecting the separation cup interface 13 and the collection bag. The red blood cell overflow sensor is used to monitor whether red blood cells flow through the conduit 6 .

[0046] In some preferred embodiments, the dynamic capacity of the separation cup 14 is set between 75ml and 160ml. This parameter range is because after the first stage of collection and separation, the concentrated red blood cells in the separation cup 14 are recovered back to the red blood cell collection branch 1.5. After the red blood cell collection branch 1.5 collects a specified amount of concentrated red blood cells, the red blood cell collection branch 1.5 is stopped, and the blood collection tube line continues to collect whole blood. Because the remaining whole blood collected by the blood collection tube line does not fill the separation cup 14, the separation cup 14 cannot collect the separated blood components by overflow. Therefore, the collected concentrated red blood cells are pumped into the separation cup 14 to keep the separation cup 14 full. This ensures that the plasma and buffy coat produced after whole blood separation can overflow smoothly through the separation cup interface 13 on one side. Therefore, it is necessary to ensure that the red blood cells collected in a single collection and separation can fill the dynamic capacity of the separation cup 14.

[0047] According to my country's blood donation standards, the single blood donation volume ranges from 200ml to 400ml. The hematocrit (Hct) of normal whole blood typically ranges from 40% to 50%. Hematocrit, a key indicator of the proportion of red blood cells (RBCs) to the volume of whole blood, directly influences the calculation of the RBC collection volume. This study, combining clinical data and blood sample analysis, selected 38% as the reference lower limit for Hct. This ensures that even in extreme cases, the clinical demand for RBCs can still be met. Furthermore, my country's blood donor health check requirements require a Hct of at least 36% to ensure blood quality and donor safety. The 38% Hct calculation benchmark is both higher than the minimum acceptable standard (36%) and provides a 2% safety margin. This allows for most minor fluctuations in Hct due to individual differences (such as temporary low Hct levels caused by dehydration and menstrual cycles), and prevents insufficient RBC collection due to Hct levels approaching the acceptable lower limit.

[0048] Based on the above parameters, when calculated based on a single minimum blood donation volume of 200ml and a hematocrit of 38%, the theoretical amount of red blood cells that can be collected is 76ml (200ml×38% = 76ml); 40% is the lower limit of the average hematocrit value of healthy adults, which is approximately 40%-45%, and can represent the general level of most blood donors. Using this value to calculate the red blood cell volume (160ml) corresponding to the maximum blood donation volume (400ml) can ensure that the separation cup capacity covers most routine blood donation scenarios. When calculated based on a single maximum blood donation volume of 400ml and a hematocrit of 40%, the amount of red blood cells that can be collected is 160ml (400ml×40% = 160ml).

[0049] In some preferred embodiments, 38% is used as the hematocrit calculation value. Whether calculating the maximum or minimum value, the reliability and practicality of the blood separation technology can be guaranteed from different perspectives. If the maximum single blood donation volume is 400 ml and the hematocrit is 38%, the theoretical amount of red blood cells that can be collected is 152 ml (400 ml × 38% = 152 ml).

[0050] In order to further optimize the separation effect, ensure that the white film layer can be completely discharged, and avoid its residue affecting the purity of red blood cells, the dynamic capacity lower limit setting needs to reserve operating space based on the theoretical minimum value. Experimental verification shows that setting the dynamic capacity minimum value to 75ml can not only ensure that the separation cup can accommodate red blood cells under the minimum single blood donation volume, but also form an effective liquid level height difference during the centrifugal separation process, so as to promote the full separation of the white film layer from the red blood cells and plasma, and completely discharge them through subsequent negative pressure suction or gravity drainage. If the dynamic capacity upper limit is set at 150ml, it can cover the red blood cell collection needs under the maximum single blood donation volume, ensure that samples with different blood donation volumes can efficiently complete component separation, and significantly improve the versatility and reliability of blood collection and processing.

[0051] It should be noted that in the existing technology, although some blood separators can separate plasma, the existing technology will return the red blood cells in the separation cup 14 to the human body after completing the first stage of collection and separation process, and is only used to extract plasma from whole blood for biopharmaceuticals. The present application is to complete red blood cell separation during the whole blood collection process, collect the separated red blood cells, and ensure that the collected red blood cells meet the quality requirements of the national standard GB / T18469 on hematocrit and residual white blood cells. To achieve this goal, the circulation path of the pipeline and the structure of the separation cup 14 are designed. It is not a simple size adjustment or pipeline splicing of the existing separation equipment, but based on the separation logic, a new technical system that adapts to the needs of directional separation of red blood cells is constructed, realizing the integrated and coordinated operation of collection and separation.

[0052] In some preferred embodiments, Figure 4 、 Figure 5 As shown, the separation cup 14 consists of a cup body 143, a cup cover 145, an upper cover 148, and a stationary head 140. The top of the cup body 143 is sealed and connected to the cup cover 145 through the cup cover sealing ring 144. The top of the cup cover 145 is connected to the stationary head 140 through a ceramic sheet 146 and a phenolic pad 147. A sealing bowl 149 is provided in the stationary head 140, and the top is connected to the separation cup interface 13 on both sides through a central tube 141. The central tube 141 extends downward to pass through the cup core 142 in the cup body 143. Under the action of centrifugal force, a separation chamber is formed between the outer wall of the cup core 142 and the inner wall of the cup body 143. The volume of the separation chamber is the dynamic capacity.

[0053] In some preferred embodiments, the cup core 142 is a cylindrical structure, and the diameter of the cup core 142 is The top of the cup core 142 is in contact with the inner side of the top of the cup body 143. The straight line distance from the top of the cup core 142 to the bottom is taken as the height of the cup core 142. , the height of the cup core 142 24.5mm-45.5mm.

[0054] In some preferred embodiments, the cross section where the radial dimension of the cup body 143 reaches the maximum value is defined as the reference cross section for determining the diameter of the cup body 143, and the straight line distance between the two opposite edges on the reference cross section is used as the diameter of the cup body 143. , the diameter of the cup body 143 83.4mm. Since the top of the cup body 143 is connected to the bottom of the cup cover 145, the top of the cup body 143 cooperates with multiple components, and the effective capacity of the top is very small and can be ignored. Therefore, this application uses the vertical height from the bottom of the cup body 143 to the lower end surface of the cup cover 145 as the height of the cup body 143. , the height of the cup body 143 The diameter of the separation chamber is 48.5 mm to 69.5 mm, so as to achieve a capacity of the separation chamber of 75 ml to 160 ml.

[0055] For example, the diameter of the cup body 143 is 83.4 mm and the height is 69.5 mm. The diameter of the cup core 142 is 44.5 mm and the height is 45.5 mm. The volume of the cup core is about 70 ml and the dynamic capacity is about 150 ml. To verify the above size adjustment, the applicant tested the dynamic capacity of the separation cup of the present application with water. The test results are as follows: Table 1 Dynamic capacity test In some preferred embodiments, the separation effect of the separation cup 14 is related to the relative centrifugal force. The relative centrifugal force (RCF) required during separation is also different. The calculation formula of the relative centrifugal force is: Where RCF is the relative centrifugal force, expressed in gravitational acceleration (g); r is the radius of the centrifuge rotor, expressed in centimeters (cm); and rpm is the rotational speed of the centrifuge, expressed in revolutions per minute.

[0056] For example, when the centrifuge speed is 7000 rpm and the radius of the centrifugal rotor is 4.17 cm, the relative centrifugal force RCF = 2284.4 g.

[0057] In some preferred embodiments, the separation cup 14 is provided with an intra-cup red blood cell sensor for monitoring whether the separation cup 14 is full within a specified time. Of course, the overflow red blood cell sensor can also be used to monitor whether the separation cup 14 is full within a specified time. The specific form is not further limited here.

[0058] The present application also provides a collection and separation method of a whole blood collection separator, which uses the whole blood collection separator as described above, including a first-stage collection and separation process. The first-stage collection and separation process is that when the red blood cell collection branch 1.5 is cut off, the anticoagulated whole blood in the blood collection tube circuit is transported to the separation cup 14, and is separated under the action of centrifugal force in the separation cup 14. The separated plasma and buffy coat layer are collected in the corresponding collection bags in turn until all the red blood cells in the separation cup 14 are stopped. The blood collection action of the blood collection tube circuit and the collection action of the collection bag are stopped, and the red blood cell preservation fluid delivery branch 1.2 is kept in a closed state. The pipeline where the plasma bag 18 is located and the red blood cell collection branch 1.5 are connected, the first peristaltic pump 26 is reversed, and the air in the plasma bag 18 is used to return the red blood cells in the separation cup 14 and collect them in the red blood cell bag 17. At this time, the collected red blood cells are concentrated red blood cells.

[0059] Taking the collection of 400 ml of whole blood and the dynamic capacity of the separation cup 14 being 150 ml as an example, the specific steps are as follows: S11, open the blood valve 29 of the blood collection tube circuit, keep the red blood cell preservation solution delivery branch 1.2 and the red blood cell collection branch 1.5 closed, collect anticoagulated whole blood from the blood collection tube circuit, and continuously deliver the anticoagulated whole blood to the separation cup 14 via the first peristaltic pump 26; In some preferred embodiments, when the blood collection tube circuit is composed of a blood collection branch and a blood preservation solution delivery branch 1.1, when the blood collection tube circuit collects anticoagulated whole blood, the blood collection branch 1.0 where the venous puncture device 1 is located collects blood, and the blood preservation solution delivery branch 1.1 where the blood transfusion socket puncture device 7 is located delivers the blood preservation solution downward under the action of the third peristaltic pump 28. The collected blood and the blood preservation solution are mixed in proportion in the pipeline to form anticoagulated whole blood, and the anticoagulated whole blood is continuously delivered to the separation cup 14 via the first peristaltic pump 26, completing the blood collection. S12, the separation cup 14 is driven by the centrifuge to rotate at high speed to separate the anticoagulated whole blood in the cup into plasma, buffy coat, and red blood cells, wherein the plasma is located at the top layer, the buffy coat is located in the middle layer, and the red blood cells are located at the bottom layer; S13, the plasma separated by the separation cup 14 first overflows from the outlet of the separation cup 14 and is collected in the plasma bag 18; S14, during the collection process, when the red blood cell overflow sensor connected to the pipeline at the outlet of the separation cup 14 detects red blood cells, the stopper of the pipeline where the plasma bag 18 is located is closed, and the stopper of the pipeline where the buffy coat layer collection bag is located is opened. The buffy coat layer overflowing from the separation cup 14 is collected in the buffy coat layer collection bag. When the buffy coat layer in the buffy coat layer collection bag reaches a specified collection volume, the stopper of the pipeline where the buffy coat layer collection bag is located is closed, and blood collection is stopped. S15: After blood collection stops, the blood valve 29 closes the blood collection tube line and keeps the red blood cell preservation solution delivery branch 1.2 where the second peristaltic pump 27 is located closed. The liquid stop structure of the line where the plasma bag 18 is located is opened, and the first peristaltic pump 26 reverses. The air in the plasma bag 18 is used to return the red blood cells in the separation cup 14 to the red blood cell bag 17. At this time, the collected red blood cells are concentrated red blood cells. S16, during the process of collecting red blood cells, when the pipeline air detector detects air in the red blood cell return pipeline, the return is stopped and the second cycle of blood collection begins. This process is repeated until the set blood collection volume is reached, that is, when the collection bag is full of 400ml, 300ml or 200ml, the blood valve 29 is closed.

[0060] Ideally, 400 ml of whole blood is collected. When the collection is completed, the dynamic capacity of 150 ml in the separation cup 14 is concentrated red blood cells. In practice, although enough blood components have been collected, the hematocrit of each person is different. This also means that the amount of blood entering the separation cup 14 through the blood collection tube line is uncertain. When only 300 ml of whole blood is collected, the separation cup 14 is full of concentrated red blood cells. At this time, although the first peristaltic pump 26 is reversed to return the red blood cells in the separation cup 14 to the red blood cell bag 17, when the remaining 100 ml of whole blood is collected, all 100 ml of whole blood will be separated in the separation cup 14. However, the whole blood entering the separation cup 14 through the blood collection tube line cannot make the separation cup 14 full. The separated plasma and buffy coat layer cannot overflow through the interface at the top of the separation cup 14, and the remaining whole blood in the separation cup 14 cannot be completely separated. Therefore, a second stage of collection and separation process is required.

[0061] The specific steps of the second stage collection and separation process are as follows: S21, if the separation cup 14 is still not detected to be full within the specified time, the blood valve 29 closes the blood collection tube line, stops blood collection, opens the red blood cell stop structure, and under the positive drive of the first peristaltic pump 26, the red blood cell bag 17 replenishes the separation cup 14 with concentrated red blood cells. The concentrated red blood cells from the red blood cell bag 17 are separated and exchanged for plasma in the separation cup 14; S22, opening the liquid stop structure of the pipeline where the plasma bag 18 is located, and collecting the plasma displaced from the separation cup 14 into the plasma bag 18; During the collection process, if the red blood cell overflow sensor detects red blood cells in the catheter connected to the outlet of the separation cup 14, the stopper of the line containing the plasma bag 18 is closed, and the stopper of the line containing the buffy coat collection bag 20 is opened. The buffy coat layer overflowing from the separation cup 14 is collected in the buffy coat collection bag 20. When the buffy coat layer in the buffy coat collection bag 20 reaches a specified collection volume, the stopper of the line containing the buffy coat collection bag 20 is closed, and replenishment is stopped. At this point, the separation cup 14 is full of concentrated red blood cells. S24, after stopping the red blood cell supplementation, the liquid stop structure of the pipeline where the plasma bag 18 is located is opened, the blood valve 29 is kept closed to close the blood collection tube pipeline, the first peristaltic pump 26 is reversed, and the concentrated red blood cells in the full cup of separation cup 14 are collected. At this time, the liquid stop structure of the pipeline where the second peristaltic pump 27 is located is opened, the second peristaltic pump 27 is reversed, and the red blood cell preservation solution delivery branch 1.2 delivers the red blood cell preservation solution connected to the pipeline downward. The red blood cell preservation solution and red blood cells merge in proportion at the blood transfusion tee to form suspended red blood cells, which are collected in the red blood cell bag 17.

[0062] Theoretically, after the second stage collection and separation process is completed, the red blood cells stored in the red blood cell bag 17 are leukoreduced suspended red blood cells. If, in fact, after the second stage collection and separation process is completed, a white film layer may still exist in the suspended red blood cells stored in the red blood cell bag 17, the third stage collection and separation process is performed.

[0063] When the red blood cell collection branch 1.5 is not connected to the leukolysis kit, the specific steps are as follows: S31, connecting one interface of the red blood cell bag 17 to the relevant pipeline of the leukocyte removal filter kit through a sterile connection method, so that the red blood cell bag 17 is connected to the leukocyte removal bag 25 through the leukocyte removal filter 23; S32, the red blood cell bag 17 is hung, and the suspended red blood cells in the red blood cell bag 17 flow into the leukocyte-reduced red blood cell bag 25 through the leukocyte removal filter 23 under the action of gravity. The leukocyte removal filter 23 is used to remove the leukocytes present in the suspended red blood cells in the red blood cell bag, so that the red blood cells in the leukocyte-reduced red blood cell bag 25 are leukocyte-reduced suspended red blood cells.

[0064] When the red blood cell collection branch 1.5 is connected to a leukolysis kit, the specific steps are as follows: S31, heat-sealing the catheter of the red blood cell collection branch 1.5 to separate it from the whole blood collection separator, while retaining the red blood cell bag 17 and the leukolysis kit; S32, the red blood cell bag 17 is hung, and the suspended red blood cells in the red blood cell bag 17 flow into the leukocyte-reduced red blood cell bag 25 through the leukocyte removal filter 23 under the action of gravity. The leukocyte removal filter 23 is used to remove the leukocytes present in the suspended red blood cells in the red blood cell bag, so that the red blood cells in the leukocyte-reduced red blood cell bag 25 are leukocyte-reduced suspended red blood cells.

[0065] To verify the collection and separation effect of this application, the applicant has conducted repeated tests and verified that the red blood cells collected using this solution can meet the quality requirements of the national standard GB / T18469 of 0.45-0.6 for hematocrit, and at the same time meet the quality requirements of the residual white blood cells in the quality control of leukocyte-depleted suspended red blood cells. The test results on hematocrit are shown in the following table: Table 2 Hematocrit test table The above is a detailed introduction to the specific implementation methods of the present application. For those skilled in the art, several improvements and modifications can be made to the present application without departing from the principles of the present application. These improvements and modifications also fall within the scope of protection of the claims of the present application.

Claims

1. A whole blood collection separator, characterized in that: include: A blood collection tube circuit, a red blood cell preservation solution delivery branch (1.2), a first branch (1.4), a red blood cell collection branch (1.5), and a separation branch (1.6) are connected through the blood collection tube circuit and each branch, wherein the blood collection tube circuit and each branch are provided with a liquid-stopping structure, wherein the blood collection tube circuit and the red blood cell collection branch (1.5) converge to be connected to one end of the first branch (1.4), and the other end of the first branch (1.4) is respectively connected to the cell preservation solution delivery branch (1.2) and the separation branch (1.6); The cell preservation fluid delivery branch (1.2) is connected to a second peristaltic pump (27), and the separation branch (1.6) is connected to a first peristaltic pump (26). The separation branch (1.6) includes a separation cup (14) and a collection bag. Two separation cup interfaces (13) are provided on the top of the separation cup (14). The separation cup interface (13) on one side is connected to the red blood cell preservation fluid delivery branch (1.2) through a catheter (6) connected to the first peristaltic pump (26) and is collected into the first branch (1.4). The separation cup interface (13) on the other side is connected to the collection bag.

2. The whole blood collection and separation device according to claim 1, characterized in that: The blood collection tube circuit and the red blood cell collection branch (1.5) are selectively connected. Under the reverse action of the first peristaltic pump (26), the red blood cell collection branch (1.5) first collects the concentrated red blood cells overflowing from the separation cup (14). After a preset amount of concentrated red blood cells are collected, if the separation cup (14) is still not full after completing the collection of all the whole blood in the blood collection tube circuit, the first peristaltic pump (26) continuously delivers concentrated red blood cells to the separation cup (14) through the forward action until the separation cup (14) is full and overflows red blood cells. The collection of concentrated red blood cells is stopped, and the reverse action of the first peristaltic pump (26) is used again to collect the concentrated red blood cells in the separation cup (14) through the red blood cell collection branch (1.5).

3. The whole blood collection and separation device according to claim 1, characterized in that: The blood collection tube circuit is a catheter (6) connected to a whole blood bag or a combined branch of a blood collection branch (1.0) and a blood preservation fluid delivery branch (1.1); a third peristaltic pump (28) is connected to the blood preservation fluid delivery branch (1.1).

4. The whole blood collection and separation device according to claim 1, characterized in that: The red blood cell collection branch (1.5) comprises a red blood cell bag (17), a catheter (6), and a liquid-stopping clamp (3).

5. The whole blood collection and separation device according to claim 1, characterized in that: The blood collection tube circuit and the red blood cell collection branch (1.5) are both connected to a blood valve (29) at the interface adjacent to the first branch (1.4). The blood valve (29) serves as a liquid-stopping structure for selectively conducting one of the blood collection tube circuit and the red blood cell collection branch (1.5).

6. The whole blood collection and separation device according to claim 4, characterized in that: The red blood cell bag (17) is provided with an interface connected to the leukoreduction kit, and the interface is connected to one end of the catheter (6) via a foldable plug (21). The other end of the catheter (6) is connected to a flow regulator (22), a leukoreduction filter (23), a second connector (24), and a leukoreduction red blood cell bag (25) via a first connector (2).

7. The whole blood collection and separation device according to claim 1, characterized in that: There are multiple collection bags, which are respectively a plasma bag (18), a transfer bag (19), and a buffy coat collection bag (20). An air detector is provided on the catheter (6) connected to the first peristaltic pump (26), and the air detector is provided between the first peristaltic pump (26) and the separation cup (14).

8. The whole blood collection and separation device according to claim 1, characterized in that: A red overflow sensor is provided on the conduit (6) connecting the separation cup interface (13) and the collection bag.

9. The whole blood collection and separation device according to claim 1, characterized in that: The separation cup (14) is composed of a cup body (143), a cup cover (145), an upper cover (148), a stationary head (140), and a separation cup interface (13). A sealing bowl (149) is provided in the stationary head (140), and the top is connected to the separation cup interfaces (13) on both sides through a central tube (141). The central tube (141) extends downward to pass through the cup core (142) in the cup body (143). Under the action of centrifugal force, a separation cavity is formed between the outer wall of the cup core (142) and the inner wall of the cup body (143). The volume of the separation cavity is the dynamic capacity. The dynamic capacity of the separation cup (14) is 75ml-160ml.

10. The whole blood collection and separation device according to claim 9, characterized in that: The diameter of the cup core (142) is 44.5 mm, the height of the cup core (142) is 24.5 mm-45.5 mm, the diameter of the cup body (143) is 83.4 mm, and the height of the cup body (143) is 48.5 mm-69.5 mm.

11. The whole blood collection and separation device according to claim 1, characterized in that: A pressure monitoring branch is also connected between the two ends of the first branch (1.4) via the first connecting piece (2), and a clamp (11) and a pressure monitor connector (12) are provided on the pressure monitoring branch.

12. A whole blood collection and separation method using a whole blood collection and separation device, comprising: The invention comprises a first-stage collection and separation process, wherein the first-stage collection and separation process is that when the red blood cell collection branch (1.5) is cut off, the anticoagulated whole blood in the blood collection tube is transported to the separation cup (14), and is separated under the action of centrifugal force in the separation cup (14), and the separated plasma and buffy coat are collected in the corresponding collection bag in turn, until the separation cup (14) is full of red blood cells, the blood collection action of the blood collection tube and the collection action of the collection bag are stopped, and the red blood cell preservation solution transport branch (1.2) is kept in a closed state, the pipeline where the plasma bag (18) is located and the red blood cell collection branch (1.5) are connected, the first peristaltic pump (26) is reversed, and the air in the plasma bag (18) is used to return the red blood cells in the separation cup (14) and collect them in the red blood cell bag (17). At this time, the collected red blood cells are concentrated red blood cells.

13. The whole blood collection and separation method according to claim 12, characterized in that: It also includes the second stage collection and separation process, the specific steps are as follows: S21, after collecting a set amount of whole blood, when blood collection is stopped and the separation cup (14) is not detected to be in a full cup state within a specified time, the blood valve (29) closes the blood collection tube circuit, and after blood collection is stopped, the red blood cell stop structure is opened, and concentrated red blood cells are added to the separation cup (14) from the red blood cell bag (17) under the positive drive of the first peristaltic pump (26), and the concentrated red blood cells from the red blood cell bag (17) are separated and replaced with plasma in the separation cup (14); S22, opening the liquid stop structure of the pipeline where the plasma bag (18) is located, and collecting the plasma displaced from the separation cup (14) into the plasma bag (18); S23, during the collection process, when the red blood cell overflow sensor detects red blood cells in the catheter connected to the outlet of the separation cup (14), the liquid stop structure of the pipeline where the plasma bag (18) is located is closed, and the liquid stop structure of the pipeline where the white film layer collection bag (20) is located is opened, and the white film layer overflowing from the separation cup (14) is collected in the white film layer collection bag (20). After the white film layer in the white film layer collection bag (20) reaches the specified collection amount, the liquid stop structure of the pipeline where the white film layer collection bag (20) is located is closed, and replenishment is stopped. At this time, the separation cup (14) is full of concentrated red blood cells; S24, after stopping the red blood cell supplementation, the stop structure of the pipeline where the plasma bag (18) is located is opened, the blood valve (29) is kept closed to close the blood collection tube pipeline, the first peristaltic pump (26) is reversed, and the concentrated red blood cells in the separation cup (14) are collected. At this time, the stop structure of the pipeline where the second peristaltic pump (27) is located is opened, the second peristaltic pump (27) is reversed, and the red blood cell preservation solution delivery branch (1.2) delivers the red blood cell preservation solution connected to the pipeline downward, and the red blood cell preservation solution and red blood cells are combined in proportion at the blood transfusion tee to form suspended red blood cells, which are collected in the red blood cell bag (17).

14. The whole blood collection and separation method according to claim 13, characterized in that: When the red blood cell collection branch (1.5) is not connected to the leukolysis kit, the third stage of collection and separation process is also included, and the specific steps are as follows: S31, connecting one interface of the red blood cell bag (17) to the relevant pipeline of the leukocyte removal filter kit through a sterile connection method, so that the red blood cell bag (17) is connected to the leukocyte removal bag (25) through the leukocyte removal filter (23); S32, the red blood cell bag (17) is hung, and the suspended red blood cells in the red blood cell bag (17) flow into the leukocyte-removed red blood cell bag (25) through the leukocyte-removed filter (23) under the action of gravity. The leukocyte-removed filter (23) is used to remove the leukocytes present in the suspended red blood cells in the red blood cell bag, so that the red blood cells in the leukocyte-removed red blood cell bag (25) are leukocyte-removed suspended red blood cells.

15. The whole blood collection and separation method according to claim 13, characterized in that: When the red blood cell collection branch (1.5) is connected to a leukoreduction kit, a third stage of collection and separation process is also included, and the specific steps are as follows: S31, heat-sealing the catheter of the red blood cell collection branch (1.5), separating it from the whole blood collection separator, and retaining the red blood cell bag (17) and the leukocyte removal kit; S32, the red blood cell bag (17) is hung, and the suspended red blood cells in the red blood cell bag (17) flow into the leukocyte-removed red blood cell bag (25) through the leukocyte-removed filter (23) under the action of gravity. The leukocyte-removed filter (23) is used to remove the leukocytes present in the suspended red blood cells in the red blood cell bag, so that the red blood cells in the leukocyte-removed red blood cell bag (25) are leukocyte-removed suspended red blood cells.

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