CN113459593A - Inflating method for producing disposable white blood cell removing plastic blood bag - Google Patents
Inflating method for producing disposable white blood cell removing plastic blood bag Download PDFInfo
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- CN113459593A CN113459593A CN202110864639.4A CN202110864639A CN113459593A CN 113459593 A CN113459593 A CN 113459593A CN 202110864639 A CN202110864639 A CN 202110864639A CN 113459593 A CN113459593 A CN 113459593A
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- gas separation
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- 210000004369 blood Anatomy 0.000 title claims abstract description 97
- 239000008280 blood Substances 0.000 title claims abstract description 97
- 229920003023 plastic Polymers 0.000 title claims abstract description 25
- 239000004033 plastic Substances 0.000 title claims abstract description 25
- 210000000265 leukocyte Anatomy 0.000 title claims description 18
- 238000004519 manufacturing process Methods 0.000 title abstract description 16
- 238000000926 separation method Methods 0.000 claims abstract description 35
- 238000012546 transfer Methods 0.000 claims abstract description 25
- 239000007788 liquid Substances 0.000 claims abstract description 12
- 230000001105 regulatory effect Effects 0.000 claims description 25
- 238000000034 method Methods 0.000 claims description 24
- 210000003437 trachea Anatomy 0.000 claims description 11
- 238000001914 filtration Methods 0.000 claims description 9
- 230000000903 blocking effect Effects 0.000 claims description 8
- 239000000654 additive Substances 0.000 claims description 6
- 230000000996 additive effect Effects 0.000 claims description 6
- 230000001954 sterilising effect Effects 0.000 abstract description 6
- 238000004659 sterilization and disinfection Methods 0.000 abstract description 6
- 238000003860 storage Methods 0.000 abstract description 2
- 238000009826 distribution Methods 0.000 abstract 1
- 239000012503 blood component Substances 0.000 description 4
- 238000012986 modification Methods 0.000 description 3
- 230000004048 modification Effects 0.000 description 3
- 230000010100 anticoagulation Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 238000010923 batch production Methods 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000003490 calendering Methods 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 239000000306 component Substances 0.000 description 1
- 230000006837 decompression Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 238000009827 uniform distribution Methods 0.000 description 1
Images
Classifications
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B31—MAKING ARTICLES OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER; WORKING PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B—MAKING CONTAINERS OF PAPER, CARDBOARD OR MATERIAL WORKED IN A MANNER ANALOGOUS TO PAPER
- B31B70/00—Making flexible containers, e.g. envelopes or bags
- B31B70/003—Opening or distending bags
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- External Artificial Organs (AREA)
Abstract
The application provides an inflation method for producing a disposable leukocyte-removing plastic blood bag, which comprises the following steps: firstly, inflating and assembling the filtered blood bag; and B: then the transfer bag group and the liquid blood adding bag are inflated and assembled. This application adopts respectively to inflate, and at every turn the gas-oil separation governing valve and the accurate control of timer of time of aerifing, can effectually guarantee that the inside gas distribution that aerifys of blood bag is even, has avoided appearing the adhesion problem in follow-up high temperature damp and hot sterilization link and storage link, and simple easy operation, with low costs satisfy mass production's needs simultaneously.
Description
Technical Field
The application belongs to the field of production processes of three types of medical apparatus and instrument products, and particularly relates to an inflation method used in the production and assembly processes of a disposable leukocyte-removing plastic blood bag.
Background
The statements in this section merely provide background information related to the present disclosure and may not necessarily constitute prior art.
A disposable plastic blood bag for removing white blood cells from blood or blood components is composed of anticoagulation whole blood bag, liquid adding bag, transfer bag, filtered blood bag, pipeline system, white blood cell removing filter and pipeline.
According to the national standard of disposable leukocyte-removing plastic blood bag products, the plastic blood bag should meet the requirements of final sterilization, and should not adhere during the sterilization process and in the storage life of which the temperature does not exceed 40 ℃. Therefore, the existing production process of the disposable leukocyte-removing plastic blood bag has a 115 ℃ damp-heat sterilization link, before the 115 ℃ damp-heat sterilization link, proper amount of gas needs to be filled in the filtered blood bag and the two transfer bags, otherwise, the blood bag body after the 115 ℃ damp-heat sterilization process is adhered, and the product is unqualified. Meanwhile, the air content of the whole set of disposable leukocyte-removing plastic blood bag products is clearly specified by the nation. Reference GB14232.1-2004 bag-type plastic container for human blood and blood components part 1: traditional blood bag 5.2.1: the total air content of the plastic blood bag system divided by the number of blood bags should not exceed 15 mL. Therefore, a process method with appropriate inflation amount is needed in blood bag manufacturing, the blood bag can be adhered when the inflation amount is reduced, the product performance can be affected when the inflation amount is increased, and the process method is suitable for mass production.
The traditional method for solving the adhesion of the disposable leukocyte-removing plastic blood bag mainly comprises three methods: one is to fill gas into all blood bags at one time in the production process, but the gas quantity in the bags is easily distributed unevenly; the other is that the polyvinyl chloride calendered film is adopted to emboss the two sides of the blood bag film in the patent document with the document number of CN200510110840.4, so the cost is high; another is, for example, patent document CN201520321564.5, in which the shape of the outer surface of the blood bag is controlled by using a surface forming mold, which also increases the production cost, and the latter two have higher requirements for the mold due to the characteristics of the blood bag film.
Disclosure of Invention
The application aims to overcome the defects in the prior art and provides an inflation method for producing a disposable leukocyte-removing plastic blood bag.
The following technical scheme is specifically adopted in the application:
a method of inflating a disposable leukocyte-depleted plastic blood bag using an inflation device comprising: oil-gas separation governing valve, oil-gas separation governing valve admit air the side and connect outside compressed air through the gas circuit air inlet, oil-gas separation governing valve gives vent to anger the air inlet that the side connects the solenoid valve body, the gas outlet of solenoid valve body connects an trachea two-way to connect through the pipeline, the solenoid valve is connected with the timer, its characterized in that includes following step:
step A: firstly, inflating and assembling the filtered blood bag;
and B: then the transfer bag group and the liquid adding blood bag are inflated and assembled.
Preferably, step a specifically comprises the following steps:
a1, setting the pressure of an oil-gas separation regulating valve and the working time of a timer, connecting a two-way connector of an air pipe into an inflating port of a filtered blood bag, opening a flow stopping clamp I, and closing a flow stopping clamp II;
a2, starting a timer, inflating the filtered blood bag by compressed air through an oil-gas separation regulating valve and an electromagnetic valve communication air pipe two-way connector until the timer times out, and ending the inflation of the filtered blood bag;
a3, closing the flow stopping clip I, pulling out the filtered blood bag inflation inlet from the trachea two-way joint, fixedly connecting the filtered blood bag inflation inlet with the blocking piece II, opening the flow stopping clip I and the flow stopping clip II, and completing the assembly of the filtered blood bag.
Preferably, step B specifically comprises the following steps:
b1, setting the pressure of the oil-gas separation regulating valve and the working time of a timer, connecting the two-way joint of the air pipe into an inflation port of the transfer bag set, and opening a flow stopping clamp III;
b2, starting a timer, inflating the transfer bag set and the additive liquid blood bag by compressed air which is communicated with the two-way joint of the air pipe through the oil-gas separation regulating valve and the electromagnetic valve until the timer times out, and ending the inflation of the transfer bag set and the additive liquid blood bag;
b3, closing the flow stopping clip III, pulling the air charging port of the transfer bag set from the two-way connector of the trachea, fixedly connecting the air charging port of the transfer bag set with the blocking piece I, and opening the flow stopping clip III to complete the assembly of the transfer bag set and the blood adding bag.
Preferably, the timer time setting value in the step A1 is 0.11-0.20S.
Preferably, the timer time setting value in the step B1 is 0.15 to 0.25S.
Preferably, the pressure set value of the oil-gas separation regulating valve is 0.090-0.120 MPa.
Preferably, the pressure set value of the oil-gas separation regulating valve is 0.092-0.110 MPa.
Preferably, the oil-gas separation regulating valve contains an oil removal and 0.01 micron-sized filtering filter element.
Preferably, the working pressure range of the electromagnetic valve is 0.01-0.50 MPa.
Preferably, the working pressure range of the electromagnetic valve is 0.05-0.20 Mpa.
Compared with the prior art, the beneficial effect of this application is:
(1) the application divides the disposable leukocyte-removing blood bag into three parts, and then the filtered blood bag, the transfer bag group and the additive liquid blood bag are respectively and independently inflated, so that the uniform distribution of inflation bodies in the blood bag can be effectively ensured, and the inflation amount and the inflation time of different blood bags can be effectively controlled;
(2) the operation is simple, the requirement of batch production of a production line is completely met, and the requirement of production of an automatic production line is met;
(3) the bag type plastic container for human blood and blood components completely meets GB14232.1-2004 part 1: traditional blood bag 5.2.1: the total air content of the plastic blood bag system is divided by the number of the blood bags and is not more than 15mL, and meanwhile, a certain air volume in the blood bags is ensured to prevent the blood bags from being adhered.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the application and, together with the description, serve to explain the application and are not intended to limit the application.
FIG. 1 is a diagram of a disposable leukocyte-depleted plastic blood bag product,
figure 2 is a schematic view of an auxiliary device for inflating a single-use leukocyte-depleted blood bag specific to the present application,
figure 3 is a flow chart of the present method of inflation for single use leukocyte-depleted blood bag production,
figure 4 is a connection diagram of an anticoagulation whole blood bag,
figure 5 is a flow chart of post-filter bag inflation,
FIG. 6 is a flow chart of the inflation of the transfer bag set and the add-on bag.
In the figure:
1. the system comprises an anticoagulant whole blood bag, 2, a filtered blood bag, 3, a transfer bag, 4, a liquid adding blood bag, 5, a closed blood taking needle, 6, a needle puncture preventing protective piece, 7, a vacuum blood taking needle, 8, a sample reserving bag, 9, a connecting pipe, 10, a blood transfusion insertion opening, 11, a blocking piece II, 12, a blood component filter, 13, a flow stopping clamp I, 14, a leukocyte removing filter, 15, a tee joint, 16, a blood taking pipe, 17, an oil-gas separation pressure regulating valve, 18, an electromagnetic valve, 19, a trachea two-way joint, 20, a pedal switch, 21, a timer, 22, an air inlet, 23, a filtered blood bag inflation opening, 24, a flow stopping clamp II, 25, a blocking piece I, 26, a transfer bag group inflation opening, 27 and a flow stopping clamp III.
The specific implementation mode is as follows:
the present application will be further described with reference to the following drawings and examples.
It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.
In the present disclosure, terms such as "upper", "lower", "left", "right", "front", "rear", "vertical", "horizontal", "side", "bottom", and the like indicate orientations or positional relationships based on those shown in the drawings, and are only relational terms determined for convenience in describing structural relationships of the parts or elements of the present disclosure, and do not refer to any parts or elements of the present disclosure, and are not to be construed as limiting the present disclosure.
Fig. 1 to 6 are preferred embodiments of the present application.
As shown in FIG. 3, the inflation method for the single-use leukocyte-depleted blood bag (400ml) of the present application comprises:
step A: firstly, inflating the filtered blood bag, adjusting the pressure of an oil-gas separation regulating valve 17 to 0.095Mpa, setting the timing time of a timer 21 to 0.16S, then connecting the empty end of a two-way connector 19 of an air pipe into an inflation port 23 of the filtered blood bag, opening a flow stopping clamp I13, closing a flow stopping clamp II 24, stepping down a foot switch 20, enabling an electromagnetic valve 18 to act, starting timing by the timer 21, enabling external compressed air to enter the oil-gas separation regulating valve 17 through an air inlet 22 for oil removal and filtering by a 0.01 micron filter, enabling clean air subjected to oil removal and filtering by the oil-gas separation regulating valve 17 to enter the inflation port 23 of the filtered blood bag from the two-way connector 19 of the air pipe through the electromagnetic valve 18, opening the flow stopping clamp I13 due to the closing of the flow stopping clamp II 24, enabling the clean air to enter the filtered blood bag 2 for inflation through the flow stopping clamp I13 and a tee joint 15 above the filtered blood bag 2, timing by the timer 21 for 0.16S, stopping inflating, namely releasing the foot switch 20 at the moment, closing the flow stopping clamp I13, pulling down the trachea two-way joint 19, fixedly connecting the filtered blood bag inflating port 23 with the blocking piece II 11, and opening the flow stopping clamp I13 and the flow stopping clamp II 24 to complete inflating of the filtered blood bag 2;
and B: the empty end of the two-way joint 19 of the air pipe is connected to the air charging port 26 of the transfer bag set, the pressure of the oil-gas separation regulating valve 17 is adjusted to 0.095Mpa, the timing time of the timer 21 is set to 0.23S, the flow stopping clamp III 27 is opened, the foot switch 20 is stepped, the electromagnetic valve 18 starts to act, external compressed air entering from the air inlet 22 is subjected to oil removal and 0.01 micron filter filtration through the oil-gas separation regulating valve 17, enters the air charging port 26 of the transfer bag set from the two-way air pipe joint 19 through the electromagnetic valve 18, the timer 21 starts to time when the electromagnetic valve 18 acts, after 0.23S, the timer 21 counts time, the inflation is stopped, the foot switch 20 is released, the flow stopping clip III 27 is closed, then the trachea two-way joint 19 is pulled down, the air charging port 26 of the transfer bag group is connected with the blocking piece I25, and finally the flow stopping clip III 27 is opened to complete the air charging of the transfer bag 3 and the liquid adding blood bag 4.
Another embodiment of the present application is a 200ml disposable leukocyte-depleted blood bag, and the structure and part names of the remaining products are identical to those of a 400ml disposable leukocyte-depleted blood bag except that the volume of all blood bags is relatively small, which is different from the previous embodiment in that the timer 21 is set to 0.13s in step a, the timer 21 is set to 0.18s in step B, and the remaining embodiments are identical to those of the 400ml disposable leukocyte-depleted blood bag.
The present application also provides an accessory device specifically for use in the method of inflating a disposable leukocyte-depleted blood bag of the present application, as shown in fig. 2, the device comprising: oil-gas separation governing valve 17, oil-gas separation governing valve 17 admit air the side and connect outside compressed air supply through gas circuit air inlet 22, oil-gas separation governing valve 17 gives vent to anger the air inlet of side connection solenoid valve 18 valve body, the gas outlet of solenoid valve 18 valve body connects an trachea two-way joint 19 through the pipeline, solenoid valve 18's coil circuit with timer 21's normally closed auxiliary contact is connected, timer 21's normally closed auxiliary contact's opposite side links to each other with foot switch 20.
Further, the pressure of the oil-gas separation regulating valve 17 is set to be 0.095Mpa, and the oil-gas separation regulating valve simultaneously comprises oil removal and a 0.01 micron-sized filtering filter element. Specifically, when external compressed air enters the oil-gas separation regulating valve 17 through the air inlet 22, a 0.01 micron-sized filtering filter element is contained in the oil-gas separation regulating valve 17, the filter element has an oil removing function, clean air subjected to oil removal and 0.01 micron-sized filtering is decompressed according to the pressure of 0.095Mpa set by the oil-gas separation regulating valve 17, and the clean air subjected to decompression and filtering enters the air inlet of the valve body of the electromagnetic valve 18.
Further, the timer 21 is an on-delay type mechanical or electronic timing device. Specifically, after the foot switch 20 is stepped on, the timer 21 is powered on and starts to count time, meanwhile, the coil of the electromagnetic valve 18 is powered on, the electromagnetic valve 18 acts, and inflation is started; when the timer 21 times, the timer 21 is disconnected, the coil of the electromagnetic valve 18 is de-energized, and the inflation is stopped.
Further, the timer 21 counts a time unit of 0.01 s.
Further, the working pressure range of the electromagnetic valve 18 is 0.05-0.20 Mpa.
The above description is only a preferred embodiment of the present application and is not intended to limit the present application, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, improvement and the like made within the spirit and principle of the present application shall be included in the protection scope of the present application.
Although the embodiments of the present application have been described with reference to the accompanying drawings, it is not intended to limit the scope of the present application, and it should be understood by those skilled in the art that various modifications and variations can be made without inventive effort by those skilled in the art.
Claims (10)
1. A method of inflating a disposable leukocyte-depleted plastic blood bag using an inflation device comprising: oil-gas separation governing valve (17), oil-gas separation governing valve (17) admit air the side and connect outside compressed air through gas circuit air inlet (22), oil-gas separation governing valve (17) give vent to anger the air inlet of side solenoid valve (18) valve body, the gas outlet of solenoid valve (18) valve body connects a trachea two to connect (19) through the pipeline, solenoid valve (18) are connected with timer (21), its characterized in that includes following step:
step A: firstly, inflating and assembling the filtered blood bag (2);
and B: then the transfer bag group (3) and the liquid adding blood bag (4) are inflated and assembled.
2. The method as claimed in claim 1, wherein the step a comprises the steps of:
a1, setting the pressure of an oil-gas separation regulating valve (17) and the working time of a timer (21), connecting a trachea two-way connector (19) into a filtered blood bag inflation inlet (23), opening a flow stopping clamp I (13), and closing a flow stopping clamp II (24);
a2, starting a timer (21), and inflating the filtered blood bag (2) by compressed air which is communicated with an air pipe two-way joint (19) through an oil-gas separation regulating valve (17) and an electromagnetic valve (18) until the timer (21) times, and ending the inflation of the filtered blood bag (2);
a3, closing the flow stopping clip I (13), pulling out the filtered blood bag inflation port (23) from the trachea two-way joint (19), fixedly connecting the filtered blood bag inflation port (23) with the blocking piece II (11), opening the flow stopping clip I (13) and the flow stopping clip II (24), and completing the assembly of the filtered blood bag (2).
3. The method as claimed in claim 1, wherein step B comprises the following steps:
b1, setting the pressure of the oil-gas separation regulating valve (17) and the working time of the timer (21), connecting the two-way joint (19) of the air pipe into the air charging port (26) of the transfer bag set, and opening the flow stopping clamp III (27);
b2, starting a timer (21), and inflating the transfer bag group (3) and the additive liquid blood bag (4) by compressed air which is communicated with the two-way joint (19) of the air pipe through the oil-gas separation regulating valve (17) and the electromagnetic valve (18) until the timer (21) times, and ending the inflation of the transfer bag group (3) and the additive liquid blood bag (4);
b3, closing the flow stopping clip III (27), pulling the air charging port (26) of the transfer bag group from the trachea two-way joint (19), fixedly connecting the air charging port (26) of the transfer bag group with the blocking piece I (25), opening the flow stopping clip III (27), and completing the assembly of the transfer bag group (3) and the additive liquid blood bag (4).
4. The method of claim 2, wherein the step of inflating the plastic blood bag for single use is performed by:
in the step A1, the time set value of the time relay (21) is 0.11-0.20S.
5. A method of inflating a disposable leukocyte-depleted plastic blood bag as recited in claim 3, wherein:
in the step B1, the time set value of the time relay (21) is 0.15-0.25S.
6. The method of claim 1, wherein the step of inflating the plastic blood bag for single use is performed by:
the pressure setting value of the oil-gas separation regulating valve (17) is 0.090-0.120 Mpa.
7. The method of claim 6, wherein the step of inflating the plastic blood bag for single use is performed by:
the pressure set value of the oil-gas separation regulating valve (17) is 0.092-0.110 Mpa.
8. The method of claim 1, wherein the step of inflating the plastic blood bag for single use is performed by:
the oil-gas separation regulating valve (17) contains an oil removing and 0.01 micron-sized filtering filter element.
9. A method of inflating a disposable leukocyte-depleted plastic blood bag as claimed in claim 1, 2 or 3, wherein:
the working pressure range of the electromagnetic valve (18) is 0.01-0.50 Mpa.
10. The method of claim 9, wherein the step of inflating the plastic disposable leukocyte-depleted blood bag comprises:
the working pressure range of the electromagnetic valve (18) is 0.05-0.20 Mpa.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202110864639.4A CN113459593B (en) | 2021-07-29 | 2021-07-29 | Inflating method for producing disposable white blood cell removing plastic blood bag |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202110864639.4A CN113459593B (en) | 2021-07-29 | 2021-07-29 | Inflating method for producing disposable white blood cell removing plastic blood bag |
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| CN113459593B CN113459593B (en) | 2022-11-22 |
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| CN113459593B (en) | 2022-11-22 |
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