Quadruple bag integrating collection, preparation and cryopreservation of umbilical cord blood hematopoietic stem cells

Abstract

The utility model relates to a cord blood hematopoietic stem cell collection, preparation and cryopreservation integrated quadruple bag which comprises a blood collection bag, a preparation bag, a plasma bag and a cryopreservation bag, and the blood collection bag is connected with the preparation bag through a first catheter and a first three-way pipe; a first flow stopping clip is arranged on the second catheter connected between the preparation bag and the first three-way pipe; the first three-way pipe is respectively connected with the plasma bag and the cryopreservation bag through a second conduit and a second three-way pipe; a second flow stopping clip is arranged on the second catheter; a third flow stopping clip is arranged on the fourth catheter connected between the plasma bag and the second three-way pipe; and a fourth flow stopping clip is arranged on the fifth catheter connected between the second three-way pipe and the cryopreservation bag. The quadruple bag is more convenient to extract cells, the cost is reduced, the consumed time is less, the recovery rate of nucleated cells is high, and the separation effect is better.

Description

Technical Field

[0001] This utility model belongs to the field of medical device technology, specifically relating to a four-piece bag that integrates the collection, preparation, and cryopreservation of umbilical cord blood hematopoietic stem cells. Background Technology

[0002] Umbilical cord blood is the blood remaining in the placenta and umbilical cord after the umbilical cord is clamped and cut. It contains hematopoietic stem cells that can rebuild the body's hematopoietic and immune systems. These stem cells can be used to treat various blood and immune system diseases. Hematopoietic stem cell transplantation has been used clinically for over 50 years, saving the lives of countless patients.

[0003] Compared to bone marrow and peripheral blood stem cells, umbilical cord blood hematopoietic stem cells have advantages such as abundant cell source, no adverse effects on donors, lower requirements for HLA matching, lower risk of viral transmission, lower incidence of severe GVHD after transplantation, and readily available physical storage, making them more advantageous than unrelated bone marrow transplantation. Currently, umbilical cord blood transplantation accounts for one-quarter of hematopoietic cell transplantation worldwide; in Japan, it accounts for as much as half. Since 2006, umbilical cord blood has been used for more adult transplants than for pediatric transplants.

[0004] There are many existing cord blood collection devices, one of the most important of which is the cord blood hematopoietic stem cell separation triple bag described in Chinese utility model patent No. 202021271916.8. This device mainly avoids blood collection obstruction due to coagulation by adding a spare cord blood collection needle 16, ensuring smooth blood collection. It also adds a needle cap to prevent the blood bag from being punctured, ensuring smooth and safe blood collection. However, the overall technical solution shows that while it mainly completes the collection of cord blood and the separation of hematopoietic stem cells, it cannot completely separate red blood cells. This results in the unavoidable presence of a small amount of plasma and red blood cells in the collected hematopoietic stem cells. The main reason for this is that during the collection of hematopoietic stem cells, a catheter shared with plasma is used, and red blood cells are not separated separately. Utility Model Content

[0005] The purpose of this invention is to provide a four-piece bag that integrates the collection, preparation, and cryopreservation of umbilical cord blood hematopoietic stem cells for efficient and better separation of hematopoietic stem cells, thereby reducing the risk of contamination.

[0006] To achieve the above objectives, this utility model provides a four-in-one bag for collecting, preparing, and cryopreserving umbilical cord blood hematopoietic stem cells, including a blood collection bag, a preparation bag, a plasma bag, and a cryopreservation bag. The special feature is that the blood collection bag is connected to the preparation bag through a first catheter and a first three-way tube.

[0007] A first flow stop clamp is installed on the second conduit connecting the preparation bag and the first tee tube;

[0008] The first three-way tube is connected to the plasma bag and the cryopreservation bag via the third catheter and the second three-way tube, respectively.

[0009] A second flow stop clamp is installed on the third conduit;

[0010] A third flow stop clamp is installed on the fourth catheter connected between the plasma bag and the second three-way tube;

[0011] A fourth flow stop clamp is installed on the fifth conduit connecting the second tee tube and the cryopreservation bag.

[0012] Furthermore, a fifth flow stop clamp is installed on the first conduit.

[0013] The advantages of this invention are: this device makes cell extraction more convenient, reduces costs and time, and not only has a high nucleated cell recovery rate but also a better separation effect. Attached Figure Description

[0014] Figure 1 This is a schematic diagram of a four-piece bag that integrates the collection, preparation, and cryopreservation of umbilical cord blood hematopoietic stem cells.

[0015] Explanation of reference numerals in the attached figures:

[0016] 1. Blood collection bag; 2. Preparation bag; 3. Plasma bag; 4. Cryopreservation bag; 5. First catheter; 6. First three-way stopcock; 7. Second catheter; 8. First stopcock clamp; 9. Third catheter; 10. Second three-way stopcock; 11. Second stopcock clamp; 12. Third stopcock clamp; 13. Fifth catheter; 14. Fourth stopcock clamp; 15. Fifth stopcock clamp; 16. Umbilical cord blood collection needle; 17. Fourth catheter; 18. Sampling port. Detailed Implementation

[0017] To further illustrate the technical means and effects of this utility model in achieving its intended purpose, the specific implementation methods, structural features and effects of this utility model are described in detail below with reference to the accompanying drawings and embodiments.

[0018] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. Obviously, the described embodiments are only some embodiments of the present utility model, and not all embodiments. Based on the embodiments of the present utility model, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of the present utility model.

[0019] In the description of this utility model, it should be understood that the terms "center", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "aligned", "overlapping", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model.

[0020] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature; in the description of this utility model, unless otherwise stated, "a plurality of" means two or more.

[0021] To achieve efficient and better separation of hematopoietic stem cells and reduce the risk of procedural contamination, this embodiment provides a method... Figure 1 The illustrated four-piece bag for collecting, preparing, and cryopreserving umbilical cord blood hematopoietic stem cells includes a blood collection bag 1, a preparation bag 2, a plasma bag 3, and a cryopreservation bag 4. The blood collection bag 1 is connected to the preparation bag 2 via a first catheter 5 and a first three-way connector 6. A first stop-flow clamp 8 is installed on a second catheter 7 connecting the preparation bag 2 and the first three-way connector 6. The first three-way connector 6 is connected to the plasma bag 3 and the cryopreservation bag 4 via a third catheter 9 and a second three-way connector 10, respectively. A second stop-flow clamp 11 is installed on the third catheter 9. A third stop-flow clamp 12 is installed on a fourth catheter 17 connecting the plasma bag 3 and the second three-way connector 10. A fourth stop-flow clamp 14 is installed on a fifth catheter 13 connecting the second three-way connector 10 and the cryopreservation bag 4. A fifth stop-flow clamp 15 is installed on the first catheter 5.

[0022] The above four-bag system enables integrated collection, preparation, and cryopreservation of umbilical cord blood hematopoietic stem cells without the need for additional cell transfer bags, saving on consumables. Compared to other umbilical cord blood hematopoietic stem cell extraction methods, this system reduces the sterilization, cutting, and splicing steps, minimizing the risk of contamination from these processes. Compared to other umbilical cord blood hematopoietic stem cell extraction methods, this device offers more convenient, lower-cost, and faster cell extraction, with a higher rate of nucleated cell recovery. Furthermore, during red blood cell separation, plasma separation, and hematopoietic stem cell collection, flow-stopping clips allow for targeted control, effectively preventing contamination from plasma or red blood cells during hematopoietic stem cell collection.

[0023] The specific separation and collection process is as follows:

[0024] At the beginning of blood collection, all the stop clamps described in the above embodiments are in the closed state. Open the stop clamp on the blood collection needle catheter and sample through the umbilical cord blood collection needle 16 so that the umbilical cord blood enters the blood collection bag 1 and mixes with the anticoagulant therein. After the blood collection is completed, close the stop clamp on the blood collection needle catheter.

[0025] Next, hydroxyethyl starch (HES) is added through the sampling port 18 on the blood collection bag 1, and then the sampling port 18 is heat-sealed. At this time, the fifth stop clamp 15 and the first stop clamp 8 are opened, and the blood sample is introduced into the preparation bag 2 through the first three-way tube 6 and the second catheter 7. The preparation bag 2 is inverted to separate the red blood cells, so that the red blood cells settle at the bottom of the preparation bag 2. After the separation is completed, the red blood cells are introduced into the blood collection bag 1 to realize the return of red blood cells and achieve waste recycling.

[0026] Close the fifth stop clamp 15, place the preparation bag 2 upright, centrifuge the blood sample inside upright, separate the plasma, and after the plasma separation is completed, open the second stop clamp 11 and the third stop clamp 12. The plasma enters the plasma bag 3 through the second catheter 7, the third catheter 9 and the fourth catheter 17. After all the plasma has entered the plasma bag 3, close the third stop clamp 12 and open the fourth stop clamp 14. The remaining nucleated cells enter the cryopreservation bag 4 through the second catheter 7, the first three-way tube 6, the third catheter 9, the second three-way tube 10 and the fifth catheter 13 to complete the collection.

[0027] During the above operations, due to the retention effect of the catheters (i.e., the second catheter 7 and the fourth catheter 17) of the preparation bag 2 and the plasma bag 3, after the critical collection of red blood cells or plasma is completed, the corresponding stop clamps can be closed in time to effectively separate red blood cells, plasma and nucleated cells. Then, the stop clamps on the catheters connected to the cryopreservation bag 4 are used to complete the collection of nucleated cells. This realizes the integrated operation of umbilical cord blood collection, umbilical cord blood separation and preparation, and umbilical cord blood cryopreservation. No additional cell transfer bags are needed in the whole process, saving consumables. Compared with other umbilical cord blood hematopoietic stem cell extraction methods, it reduces the sterilization, cutting and splicing steps in the process, thereby minimizing the risk of contamination caused by sterilization, cutting and splicing during the operation. Compared with other umbilical cord blood hematopoietic stem cell extraction methods, this device is more convenient to extract cells, reduces costs and time, and has a higher nucleated cell recovery rate.

Claims

1. A four-piece bag for collecting, preparing, and cryopreserving umbilical cord blood hematopoietic stem cells, comprising a blood collection bag (1), a preparation bag (2), a plasma bag (3), and a cryopreservation bag (4), characterized in that: The blood collection bag (1) is connected to the preparation bag (2) through the first catheter (5) and the first three-way tube (6); A first flow stop clamp (8) is provided on the second conduit (7) connecting the preparation bag (2) and the first tee tube (6); The first three-way tube (6) is connected to the plasma bag (3) and the cryopreservation bag (4) through the third catheter (9) and the second three-way tube (10), respectively; A second flow stop clamp (11) is provided on the third conduit (9); A third stop clamp (12) is installed on the fourth catheter (17) connected between the plasma bag (3) and the second three-way tube (10); A fourth stop clamp (14) is provided on the fifth conduit (13) connecting the second three-way pipe (10) and the cryopreservation bag (4).

2. The four-piece bag according to claim 1, characterized in that: The first conduit (5) is provided with a fifth flow stop clamp (15).

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