Disposable plasma separation consumable

Abstract

The utility model relates to a disposable plasma separation consumable which comprises a plasma single bag and a hemostix assembly communicated with an input port in the upper end of the plasma single bag. The device further comprises a pipeline and at least one plasma adding bag or / and plasma collecting bag. The plasma single bag is communicated with the plasma adding bag or / and the plasma collecting bag through a pipeline to realize a closed state; a puncture outfit can be connected through a pipeline tee joint so as to add functional liquid; or a pressure monitor and an exhaust valve are connected to ensure that the pressure and the flow speed of the pipeline are normal. The plasma split charging device is integrally assembled, pipelines do not need to be assembled and disassembled, and the complexity of plasma split charging is greatly reduced; a full-closed state and an integral sterilization state can also ensure a sterile state in the product; the product is isolated from the external environment, and has the functions of plasma subpackaging, multifunctional fluid infusion, pressure balance and the like, so that the functions of plasma subpackaging and preservative fluid adding are realized in a sterile state, and the defects of plasma subpackaging are fundamentally overcome.

Description

TECHNICAL FIELD

[0001] The utility model relates to the field of medical apparatus and instruments, and particularly relates to disposable plasma separation consumables. BACKGROUND

[0002] The statements in this section merely provide background information related to the present disclosure and can constitute the prior art. During the implementation of the utility model, the inventors found at least the following problems in the prior art.

[0003] Plasma separation is one of the common collection methods in the field of apheresis, and the plasma bag is a very important component with important functions such as collection and storage. The existing disposable centrifugal plasma separator consumables, as shown in the drawings, only have a single plasma bag, and the plasma bag specifications are 1000ml and 1300ml. During the plasma collection process, the plasma is collected, and after the collection is completed, the upper end pipeline of the plasma bag is packaged, and the plasma bag is stored. Figure 4

[0004] After the plasma is collected into a single bag, according to the needs, the split charging operation will be performed. Due to the need to maintain sterility, the existing plasma split charging process is relatively complex and requires partitioning and hierarchical processing.

[0005] In the existing split charging process, the clean area required for sterile drug filling can be divided into four levels from high to low according to the cleanliness level, namely A, B, C and D. C and D levels generally refer to the clean area with low importance in the operation steps of sterile drug filling. B level generally refers to the area for filling liquid medicine into the filling bag. A level is a high-risk area, which is generally the area for filling liquid medicine into the vial. When the filling bag is used, it is first transferred from the storage area to the C and D levels, and then transferred to the B level after wiping the outer surface of the filling bag with sterile 75% ethanol in the C and D levels. Then the liquid medicine is pumped into the filling bag through the liquid injection device. After the liquid injection is completed, the outer surface of the filling bag is wiped with sterile 75% ethanol, and then the vial can be filled in the A level. This filling bag needs multiple cleaning and disinfection procedures to remove microorganisms when used, which is low in efficiency and still has the risk of carrying microorganisms through wiping.

[0006] In order to improve the efficiency, the patent with the patent name "a hierarchical quick-release filling bag" and the application number 202322305447.7 is designed with three packaging layers on the outside of the plasma bag in sequence, and a liquid inlet is provided on the bag body and extends to the liquid inlet pipeline between the above packaging layers. The patent can avoid the pollution of the bag body in the B level area, C level area or D level area by removing the corresponding packaging layer in different areas through hierarchical quick-release, and does not need to use sterile 75% ethanol for wiping, which is simple in operation and improves the efficiency of the filling bag when used.

[0007] ​Although the above-mentioned patent makes certain improvements, simplifies the operation process, and reduces the risk of pollution, it still retains the defects in the existing split operation. Specifically:

[0008] 1. Artificial disassembly of the pipeline is time-consuming and labor-intensive, and the user experience is not good;

[0009] 2. The risk of error in manually disassembling the pipeline is extremely high;

[0010] 3. Disassembling the pipeline (disconnecting the sterile disconnecter between the second pipeline and the third pipeline), the residual liquid in the pipeline spills out, causing environmental pollution;

[0011] 4. Environmental pollution of the pipeline interior (the sterile connector is connected to the filter, and operating in a B-level environment will pollute the interior of the pipeline);

[0012] 5. Product grading unpacking, the process is complicated. SUMMARY

[0013] In view of the above problems, the purpose of the present utility model is to solve some of the problems in the prior art, or at least to alleviate these problems.

[0014] The disposable plasma separation consumables include a plasma single bag and a blood collector assembly in communication with an input port at the upper end of the plasma single bag; further comprising a pipeline and at least one plasma addition bag or / and plasma collection bag; the lower end of the plasma single bag is provided with an output port in communication with the first end of the pipeline; the second end of the pipeline is in communication with the input port of the plasma addition bag or / and plasma collection bag, so as to flow the plasma in the plasma single bag into the bag body of the plasma addition bag or / and plasma collection bag; a liquid stop clamp is arranged at the pipeline in communication with the output port of the lower end of the plasma single bag.

[0015] The input port at the upper end of the plasma addition bag is provided with a needle injection member, and the pipeline is in communication with the input port of the plasma addition bag through the needle injection member; the lower end of the plasma addition bag is provided with a transfusion connector socket.

[0016] Preferably, a liquid stop clamp is arranged at the pipeline in communication with the input port at the upper end of the plasma addition bag or / and plasma collection bag.

[0017] The disposable plasma separation consumables further comprise a puncture device; the puncture device is in communication with the pipeline through a tee joint; a liquid stop clamp is arranged at the transfusion tube between the puncture device and the tee joint.

[0018] The disposable plasma separation consumables further comprise a pressure monitor; the pressure monitor is in communication with the pipeline through a tee joint; a liquid stop clamp is arranged at the transfusion tube between the pressure monitor and the tee joint.

[0019] Optionally, the disposable plasma separation consumable further comprises an exhaust valve; the exhaust valve is communicated with the pipeline through a tee joint; a liquid stop clamp is arranged at a liquid delivery tube between the exhaust valve and the tee joint.

[0020] Optionally, an upper end of the plasma adding bag or / and the plasma collecting bag is provided with an exhaust valve; a liquid stop clamp is arranged at a liquid delivery tube between the exhaust valve of the plasma adding bag or / and the plasma collecting bag and a lower end bag body.

[0021] The disposable plasma separation consumable further comprises a power pump arranged on the pipeline, which is used to deliver the plasma in the plasma single bag into the bag body of the plasma adding bag or / and the plasma collecting bag.

[0022] Preferably, the power pump is a peristaltic pump.

[0023] The utility model has the following beneficial effects:

[0024] 1. The whole is assembled, and does not need to assemble and disassemble the pipeline when subpackaging;

[0025] 2. The whole is sterilized, and the internal sterile state of the product is ensured;

[0026] 3. The product is isolated from the external environment, and the operation environment is not affected by the external environment;

[0027] 4. The bag body has powerful functions: plasma subpackaging, multifunctional liquid supplement, liquid taking, detection and the like;

[0028] 5. The extension function is powerful: there is a puncture device infusion interface to supplement functional liquid; there is a pressure sensor to monitor the pressure value in the pipeline; there is an exhaust valve to exhaust, so that the bag body and the pipeline maintain pressure balance with the external environment. BRIEF DESCRIPTION OF DRAWINGS

[0029] The above structure of the utility model can be further illustrated by the following non-limiting examples shown in the drawings.

[0030] Figure 1 It is a schematic view of the utility model with a plasma adding bag and a plasma collecting bag;

[0031] Figure 2 It is a schematic view of the utility model with only a plasma adding bag;

[0032] Figure 3 It is a schematic view of the utility model with only a plasma collecting bag;

[0033] Figure 4 It is a schematic view of the existing plasma bag.

[0034] Wherein: 1-plasma single bag; 2-plasma addition bag; 3-plasma collection bag; 4-puncture device; 5-liquid stopper; 6-three-way; 7-vent valve; 8-injection member; 9-pressure monitor; 10-blood collection device assembly; 11-infusion connector socket; 12-peristaltic pump. DETAILED DESCRIPTION

[0035] The embodiments of the present application are only used for illustrating the present application but not limiting the present application, and various substitutions and changes can be made according to the ordinary technical knowledge and common practices in the art without departing from the technical thought of the present application, which should be included in the scope of the present application.

[0036] In order to fundamentally solve the defects in the split operation, the applicant designs the following scheme.

[0037] As shown in Figure 1 or 2 or 3, the disposable plasma separation consumables include a plasma single bag 1 and a blood collection device assembly 10 communicated with an input port at the upper end of the plasma single bag 1; further include a pipeline and at least one plasma addition bag 2 or / and plasma collection bag 3; the lower end of the plasma single bag 1 is provided with an output port communicated with a first end of the pipeline; a second end of the pipeline is communicated with an input port of the plasma addition bag 2 or / and plasma collection bag 3, so as to flow the plasma in the plasma single bag 1 into the bag body of the plasma addition bag 2 or / and plasma collection bag 3; a liquid stopper 5 is arranged at the pipeline communicated with the output port of the lower end of the plasma single bag 1.

[0038] The pipeline is added at the lower end of the plasma single bag 1, and can be communicated with one or more plasma addition bags 2 or / and plasma collection bags 3 through a three-way 6 and the like, so that the entire disposable consumables form a closed loop through the pipeline, the product is completely isolated from the external environment, the operation environment of the split operation is not affected by the external environment, and the process of the split operation is fundamentally changed. Since the closed loop is formed between the bag bodies, the overall sterilization can be performed to ensure the sterile state inside the product. Not only the bag is not needed to be disassembled and transported to each area for sterilization, but also the pipeline is not needed to be assembled and disassembled, and the degree of sterilization is further improved.

[0039] In addition, since the liquid stopper 5 is additionally arranged at the pipeline at the lower end of the plasma single bag 1, the plasma collection operation can be smoothly performed by only closing the pipeline during plasma collection, and is not affected by the bag bodies or devices connected with the pipeline.

[0040] The liquid stopper 5 arranged at the pipeline communicated with the output port of the lower end of the plasma single bag 1 can be arranged on the pipeline close to the lower end of the plasma single bag 1 as shown in Figure 1 , and can be arranged at the pipeline connected with the input port of each plasma addition bag 2 or / and plasma collection bag 3.

[0041] The plasma in the plasma single bag 1 can be conveniently transferred to the plasma adding bag 2 or / and the plasma collecting bag 3 by opening the corresponding liquid stopper 5 in the pipeline, closing the liquid stopper 5 in the bypass, and placing the plasma single bag 1 higher than the other bags, so that the plasma in the plasma single bag 1 can flow into the plasma adding bag 2 or / and the plasma collecting bag 3 by gravity.

[0042] Of course, a power pump can also be used. The disposable plasma separation consumable also includes a power pump arranged on the pipeline, as shown in Figure 1 or 2 or 3, for transferring the plasma in the plasma single bag 1 to the plasma adding bag 2 or / and the plasma collecting bag 3. The power pump can be a peristaltic pump 12 arranged on the pipeline, which continuously transfers the plasma into the bag to be input by using the peristaltic pump 12.

[0043] The peristaltic pump 12 can be arranged on the pipeline again when subsequent dispensing operations are performed. The peristaltic pump 12 is a prior art device.

[0044] The plasma single bag 1 can be individually connected to one or more plasma adding bags 2 or plasma collecting bags 3 through the pipeline, as shown in Figure 2 The input port of the plasma adding bag 2 or the plasma collecting bag 3 is connected to the pipeline, and a liquid stopper 5 is arranged at the pipeline, which can also be closed during the plasma collection operation, thereby minimizing the impact on the plasma collection operation.

[0045] When the subsequent use of the collected plasma is uncertain, the plasma single bag 1 can also be connected to the plasma adding bag 2 and the plasma collecting bag 3 through the pipeline at the same time, as shown in Figure 1 The input port of the upper end of the plasma adding bag 2 and the plasma collecting bag 3 is connected to the pipeline, and a liquid stopper 5 is arranged at the pipeline. When subsequent dispensing operations are required, only the liquid stopper 5 above the corresponding bag is opened, and the corresponding function can be realized.

[0046] The manufacturer can set the number of plasma adding bags 2 or / and plasma collecting bags 3 after the pipeline of the plasma single bag 1 according to the needs. According to the actual test of the applicant, when the specification of the plasma single bag 1 is 1000 ml, the appropriate number of plasma adding bags 2 with a specification of 1000 ml is 1-2, and the appropriate number of plasma collecting bags 3 with a specification of 1000 ml is 2-3; when the specification of the plasma single bag 1 is 1300 ml, the appropriate number of plasma adding bags 2 with a specification of 1000 ml is 1-3, and the appropriate number of plasma collecting bags 3 with a specification of 1000 ml is 2-4.

[0047] As shown in Figure 2As shown, the upper inlet of the plasma addition bag 2 is equipped with an injection device 8, and the tubing is connected to the inlet of the plasma addition bag 2 through the injection device 8. Since the plasma addition bag 2 also needs to be filled with functional fluid, the lower end of the plasma addition bag 2 is equipped with an infusion connector 11. Workers can extract the liquid through the injection device 8 for testing to ensure it meets requirements. Of course, liquid can also be added to the plasma addition bag 2 through the injection device 8. However, since a large amount of functional fluid is generally injected, the efficiency of replenishing through the needle and injection device 8 is low. Therefore, replenishment is mostly done through the infusion connector 11, which is not only very convenient to operate but also ensures a sterile environment.

[0048] The injection molding component 8 generally includes an injection body and a rubber component. The injection body is obtained through injection molding, and then the purchased rubber component is placed into the injection body. Using specialized equipment with blunt edges, the rubber component is embedded into the injection body. When inspection is required, a steel needle is simply inserted into the rubber component to extract liquid from the tubing for testing.

[0049] The infusion connector 11 has the same structure as those commonly found on the market, mainly consisting of an injection-molded infusion connector and an infusion plug, with the two components combined together. The infusion connector connects to the output port of the plasma addition bag 2. To add functional fluid, first unscrew the infusion plug, then insert the infusion connector into the infusion connector. Compared to existing plasma bags, this application offers safer and more hygienic operation, is less prone to contamination, significantly reduces operational complexity, and improves efficiency.

[0050] In addition, not only can a large amount of liquid be input through the infusion connector 11, but a large amount of liquid can also be output through it, and the working principle is the same.

[0051] It is also possible to Figures 1-3 As shown, the disposable plasma separation consumable also includes a puncture device 4; the puncture device 4 is connected to the tubing via a T-junction 6; a stop clamp 5 is provided at the infusion tubing between the puncture device 4 and the T-junction 6. The puncture device 4, equipped with the stop clamp 5, allows the functional fluid to flow into the plasma addition bag 2 through the tubing and the T-junction 6, thereby enabling the addition of saline and anticoagulants, thus providing the plasma addition function of this application. Of course, if it is necessary to replenish fluid to the plasma collection bag 3, it can also be done through the puncture device 4.

[0052] Because this consumable consists of multiple bags and pipes, the entire consumable is in a closed state after plasma collection is completed and the upper inlet of plasma bag 1 is sealed. In practice, the applicant found that when plasma from plasma bag 1 is transferred to plasma addition bag 2 or plasma collection bag in this closed state, the increased pressure within the bag can affect the transfer capacity. Therefore, the applicant has addressed the pressure issue to ensure proper transfer. Figure 1or 3, the disposable plasma separation consumables also comprise a pressure monitor 9; the pressure monitor 9 is communicated with the pipeline through the three-way joint 6; a liquid stop clamp 5 is arranged at the infusion tube between the pressure monitor 9 and the three-way joint 6. The pressure monitor 9 is arranged between the plasma single bag 1 and the to-be-input bag body, and monitors the pressure value during the use of each function mode, so as to realize the pressure detection of the pipeline.

[0053] In addition, the applicant also designs the exhaust valve 7 to adjust the pipeline pressure, so as to realize the pressure balance of the pipeline and make the delivery normally. Figure 1 As shown in FIG. 3, the disposable plasma separation consumables also comprise an exhaust valve 7; the exhaust valve 7 is communicated with the pipeline through the three-way joint 6; a liquid stop clamp 5 is arranged at the infusion tube between the exhaust valve 7 and the three-way joint 6.

[0054] Of course, the upper end of the plasma adding bag 2 or / and the plasma collecting bag 3 can also be provided with the exhaust valve 7; the exhaust valve 7 of the plasma adding bag 2 or / and the plasma collecting bag 3 is provided with the liquid stop clamp 5 at the infusion tube of the lower end bag body.

[0055] Through the test of the applicant, it is found that the pipeline pressure below 100 Kpa and the flow control below 150 ml / min can make the whole system normally run, but it is not the smaller the better. The design of the pressure monitor 9 and the exhaust valve 7 can also close the exhaust valve 7 when the pressure is too small, so as to maintain the liquid flow rate and ensure the efficiency of the plasma delivery, so as to ensure the efficient operation of the plasma delivery.

[0056] The length of the whole pipeline can be adjusted according to the actual use. The consumables in the application can also be selected according to the actual needs.

[0057] The operation process of the application is very simple, which only needs to open the corresponding liquid stop clamp 5 before performing a certain operation, and close the irrelevant liquid stop clamp 5.

[0058] The specific operation process is as follows:

[0059] 1. Plasma collection operation:

[0060] The liquid stop clamp 5 of the output port at the lower end of the plasma single bag 1 is closed, and the plasma collection operation can be performed. After the plasma collection is completed, the blood collection device assembly 10 is taken out, and the input port at the upper end of the plasma single bag 1 is closed by using heat sealing or the like.

[0061] 2. Plasma adding bag 2 operation:

[0062] Open the liquid stopper 5 between the plasma single bag 1 and the plasma adding bag 2, close the liquid stopper 5 of the bypass pipeline, connect the pressure monitor 9, the power source can be provided by gravity and the peristaltic pump 12, keep the pipeline pressure below 100Kpa and the flow rate below 150ml / min. The infusion connector 8 can be used to extract the plasma from the plasma adding bag 2 for examination. Then insert the infusion connector into the infusion connector port 11, and then the functional liquid can be added into the plasma adding bag 2, and the adding function of the plasma is realized. Of course, the functional liquid can also be added through the puncture device 4.

[0063] 3. The operation of the plasma collecting bag 3:

[0064] The operation of the plasma adding bag 2 is the same. Generally, the functional liquid does not need to be added into the plasma collecting bag 3. Of course, if the functional liquid needs to be added into the plasma collecting bag 3, it can be realized through the puncture device 4. The pipeline pressure is also kept below 100Kpa and the flow rate is controlled below 150ml / min.

[0065] 4. The operation of the puncture device 4:

[0066] Open the liquid stopper 5 between the puncture device 3 and the plasma adding bag 2 or the plasma collecting bag 3, close the liquid stopper 5 of the bypass pipeline, and open the pipeline connected with the pressure monitor 9. The power source can be provided by gravity and the peristaltic pump 12, the pipeline pressure is below 100Kpa and the flow rate is controlled below 150ml / min, and then the puncture device 3 can add the functional liquid into the plasma adding bag 2 or the plasma collecting bag 3, and the adding function is realized.

[0067] The consumables of the present application are integrally assembled, and do not need to be assembled and disassembled during the splitting; the whole is sterilized, which ensures the sterile state of the product; the product is isolated from the external environment, so that the operating environment is not affected by the external environment; the bag body has strong functions, such as plasma splitting, multi-functional liquid supplementing, and liquid taking; and the extension function is strong, the puncture device 4 infusion interface can supplement the functional liquid, and the pressure monitor 9 and the exhaust valve 7 are designed according to the whole sealing state, so that the bag body and the pipeline maintain pressure balance with the outside, to ensure the normal delivery. The present application realizes the functions of plasma splitting and adding of the preservation liquid in a sterile state, and greatly simplifies the original operation process of plasma splitting.

Claims

1. A disposable plasma separation consumable, comprising a plasma bag (1) and a blood collection device assembly (10) connected to the inlet at its upper end; characterized in that, It also includes tubing, and at least one plasma addition bag (2) and / or plasma collection bag (3); the lower end of the plasma bag (1) is provided with an outlet, which is connected to the first end of the tubing; the second end of the tubing is connected to the inlet of the plasma addition bag (2) and / or plasma collection bag (3) to allow plasma in the plasma bag (1) to flow into the bag body of the plasma addition bag (2) and / or plasma collection bag (3); a stop clamp (5) is provided at the tubing connected to the outlet at the lower end of the plasma bag (1).

2. The disposable plasma separation consumable according to claim 1, characterized in that, The upper end of the plasma addition bag (2) is provided with an injection device (8), and the pipeline is connected to the inlet of the plasma addition bag (2) through the injection device (8); the lower end of the plasma addition bag (2) is provided with an infusion connector socket (11).

3. The disposable plasma separation consumable according to claim 1, characterized in that, A stop clamp (5) is provided at the inlet of the tubing connected to the upper end of the plasma addition bag (2) and / or plasma collection bag (3).

4. The disposable plasma separation consumable according to claim 1, characterized in that, It also includes a puncture device (4); the puncture device (4) is connected to the pipeline through a tee (6); a stop clamp (5) is provided at the infusion tube between the puncture device (4) and the tee (6).

5. The disposable plasma separation consumable according to claim 1, characterized in that, It also includes a pressure monitor (9); the pressure monitor (9) is connected to the pipeline via a tee (6); a stop clamp (5) is provided at the infusion tube between the pressure monitor (9) and the tee (6).

6. The disposable plasma separation consumable according to claim 5, characterized in that, It also includes an exhaust valve (7); the exhaust valve (7) is connected to the pipeline through a tee (6); a stop clamp (5) is provided at the infusion pipe between the exhaust valve (7) and the tee (6).

7. The disposable plasma separation consumable according to claim 5, characterized in that, The upper end of the plasma addition bag (2) and / or plasma collection bag (3) is provided with an exhaust valve (7); the exhaust valve (7) of the plasma addition bag (2) and / or plasma collection bag (3) and the infusion tube of the lower end of the bag body are provided with a stop clamp (5).

8. The disposable plasma separation consumable according to claim 1, characterized in that, It also includes a power pump, located on the pipeline, for delivering plasma from the plasma bag (1) to the plasma addition bag (2) or / and plasma collection bag (3).

9. The disposable plasma separation consumable according to claim 8, characterized in that, The power pump is a peristaltic pump (12).

Images