Automatic tester for human blood and blood component bag plastic container

Abstract

The present invention discloses an automated tester for a bag-type plastic container of human blood and blood components, which belongs to the technical field of medical device inspection. The structure thereof includes one or more test units, each of which includes a liquid injection part and a pressurizing part; the liquid injection part includes a liquid injection pump, the water inlet of the liquid injection pump is connected to a water inlet tank, and the water inlet and the water outlet of the liquid injection pump are respectively provided with electromagnetic valves; the pressurizing part includes a pressurizing base, a pressurizing base and a pressing plate, the pressing plate is located above the pressurizing base, and the pressing plate is connected to a driving device for driving it to press down and rise; the electromagnetic valve is connected to a controller of the driving device, and the pressurizing part is provided with a pressure feedback device, which is connected to the controller of the driving device. The technical solution exemplified by the present invention is used for conducting anti-leakage tests and pressurized emptying tests of bag-type plastic containers of human blood and blood components, thereby improving the test efficiency and accuracy.

Description

Technical Field

[0001] The invention relates to the technical field of medical device inspection, in particular to the field of medical bag-type plastic container inspection, in particular to an automatic tester for bag-type plastic containers of human blood and blood components. Background Art

[0002] Disposable plastic blood bags and other bag-type plastic containers for blood and blood components are commonly used medical devices in clinical practice. Their general structure is a bag-type plastic container and ancillary blood bags with blood collection tubes, blood collection needles, blood transfusion ports, anticoagulants or maintenance fluids, and transfer tubes. They are mainly used for blood collection and preparation of various blood components. Blood is closely related to human life safety. Such medical devices must undergo strict quality inspections before they can be put on the market.

[0003] The national standard GB14232.1-2004 "Bag-type plastic containers for human blood and blood components Part 1: Traditional blood bags" provides a normative overview of the inspection methods for this type of container, but does not provide corresponding inspection devices. In current operations, staff use existing pressurized equipment to conduct anti-leakage tests on bag-type plastic containers, but there are still the following deficiencies in actual applications:

[0004] 1. Before the test, the container needs to be filled with liquid and then placed on the testing machine. The operation steps are cumbersome, which increases the workload of the staff and reduces efficiency;

[0005] 2. The current pressurizing equipment can only simply pressurize to achieve anti-leakage test. When performing pressurized emptying test, the current equipment cannot maintain stable pressure and cannot determine the end of the test, which not only leads to poor accuracy of test results, but also leads to a waste of time;

[0006] 3. Currently, the quality inspection of bag-type plastic containers can only be carried out one at a time, which is inefficient.

[0007] The quality and safety of bag-type plastic containers for human blood and blood components are directly related to the quality of clinical treatment and the life safety of patients. Therefore, designing a comprehensive and highly reliable tester for bag-type plastic containers for human blood and blood components is a problem that needs to be solved at present. Summary of the invention

[0008] In order to solve the deficiencies in the above-mentioned prior art, the object of the present invention is to provide an automated tester for bag-type plastic containers of human blood and blood components, which is used to perform anti-leakage tests and pressurized emptying tests on bag-type plastic containers of human blood and blood components, thereby improving the test efficiency and accuracy.

[0009] The technical solution adopted by the present invention to solve the technical problem is:

[0010] Provided is an automated tester for bag-type plastic containers of human blood and blood components, comprising one or more test units, each of which comprises a liquid injection part and a pressurizing part; the liquid injection part comprises a liquid injection pump, the water inlet of the liquid injection pump is connected to a water inlet tank, and the water inlet and outlet of the liquid injection pump are respectively provided with electromagnetic valves; the pressurizing part comprises a pressurizing base and a pressing plate, the pressing plate is located above the pressurizing base, and the pressing plate is connected to a driving device for driving it to press down and rise; the electromagnetic valve is connected to a controller of the driving device.

[0011] Furthermore, the injection part and the pressurizing part are jointly arranged inside the shell, and the inside of the shell is divided into three cavities from top to bottom. The driving device is located in the top cavity, the pressurizing base and the pressure plate are located in the middle cavity, the injection part is located in the bottom cavity, and the actuating part of the driving device extends into the middle cavity and is connected to the pressure plate.

[0012] Furthermore, the middle cavity and the bottom cavity are both provided with openable doors.

[0013] Furthermore, a transparent plate is provided on the door of the middle cavity.

[0014] Furthermore, the test unit is provided with a water outlet box, the water outlet box is connected to a liquid outlet pipeline, the liquid outlet pipeline is connected to a detected container, the detected container is connected to a pressure gauge, and the pressure gauge is connected to a controller of the drive device.

[0015] Furthermore, the test units are provided in plurality, and the plurality of test units share a water inlet tank and a water outlet tank.

[0016] Furthermore, the pressure gauge is installed on the housing.

[0017] Furthermore, the controller of the driving device is connected to a flow meter, and the flow meter is used to measure the discharge flow of the detected container.

[0018] Furthermore, a weighing device is provided below the pressurizing base, and the weighing device is connected to a controller of the driving device.

[0019] Furthermore, the pressurizing part is provided with a distance sensor for detecting the distance between the press plate and the pressurizing base, and the distance sensor is connected to the controller of the driving device.

[0020] Furthermore, the test unit is arranged in a temperature control box, and a refrigeration device is arranged in the temperature control box.

[0021] Compared with the prior art, the present invention has the following beneficial effects:

[0022] 1. The automated tester of the present invention can sequentially complete the liquid filling, anti-leakage test and pressurized emptying test after assembling the bag-type plastic container to be tested, thereby simplifying the manual operation and improving the test efficiency.

[0023] 2. The automated tester of the present invention can be equipped with multiple test units on one instrument to simultaneously test multiple bag-type plastic containers, thereby further improving the testing efficiency.

[0024] 3. The automated tester of the example of the present invention has a shell configured as three cavities from top to bottom, and the liquid injection part and the pressurizing part are arranged longitudinally, so the structure is more compact, the floor space is reduced, and the space utilization rate is higher.

[0025] 4. The automated tester of the example of the present invention is provided with openable doors on the middle cavity and the bottom cavity, and a transparent plate is provided on the door of the middle cavity, which is very convenient for the operation of the test and the observation of the test process, and is easy to use.

[0026] 5. The automated tester of the example of the present invention is provided with a pressure gauge for measuring the pressure in the container to be tested, which can detect the pressure in the container to be tested during pressurization and emptying in real time; a weighing device is provided under the pressurization base, which can measure the weight of the container to be tested; the pressurization part is provided with a distance sensor for detecting the distance between the pressure plate and the pressure base, which can detect the corresponding distance; a flow meter is provided for measuring the discharge flow of the container to be tested, and it can be determined that the emptying is completed when the discharge flow is significantly reduced; through any one of the above data or a combination of multiple data, it can be determined whether the container to be tested is emptied, and the time of the end of the test can be accurately fed back, thereby improving the test efficiency and accuracy; the liquid outlet pressure is monitored in real time and the signal is fed back to the controller of the driving device, and the controller adjusts the pressing speed of the driving device in real time so that the pressure plate can maintain the required pressure on the container to press down and empty it, which meets the detection requirements and has a high reference value for the test results.

[0027] 6. In the automated tester of the example of the present invention, multiple test units share a water inlet tank and a water outlet tank, and the pressure gauge is installed on the shell, making the device structure more compact and space-saving.

[0028] 7. The automated tester of the present invention sets the test unit in a temperature-controlled box, and can perform tests at room temperature or at a constant temperature of 4°C as needed. The test results are more comprehensive and have a higher reference value. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Other features, objects and advantages of the present application will become more apparent by reading the detailed description of non-limiting embodiments made with reference to the following drawings:

[0030] Figure 1 This is a front view of the first embodiment of the present invention;

[0031] Figure 2 It is a left side view of the first embodiment of the present invention;

[0032] Figure 3 This is a schematic diagram of the internal structure of Embodiment 1 of the present invention;

[0033] Figure 4 It is a schematic diagram of the three-dimensional structure of the first embodiment of the present invention;

[0034] Figure 5 This is a front view of the second embodiment of the present invention;

[0035] Figure 6 This is a schematic diagram of the structure of Embodiment 3 of the present invention;

[0036] Figure 7 It is a schematic structural diagram of a container to be detected according to an embodiment of the present invention.

[0037] In the figure: 1 shell, 2 top cavity, 3 middle cavity, 4 bottom cavity, 5 pressure gauge, 6 pressure plate, 7 pressurized base, 8 support foot, 9 junction box, 10 incoming wiring terminal, 11 outgoing wiring terminal, 12 equipment inlet, 13 water inlet / drainage port, 14 injection pump, 15 solenoid valve, 16 drive device, 17 transparent plate, 18 temperature control box, 19 water inlet tank, 20 water outlet tank, 21 tested container, 22 blood collection tube, 23 drainage port, 24 pressure gauge connecting pipe. DETAILED DESCRIPTION

[0038] The technical solution of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments.

[0039] The components of the embodiments of the present invention generally described and shown in the drawings herein may be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention.

[0040] Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in the field without making any creative work shall fall within the scope of protection of the present invention.

[0041] In the description of the present invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying 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 limiting the present invention. In addition, the terms "first", "second", and "third" are used for descriptive purposes only, and cannot be understood as indicating or implying relative importance.

[0042] In the description of the present invention, it should be noted that, unless otherwise clearly specified and limited, the terms "installed", "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 or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0043] It should be noted that, in the absence of conflict, the embodiments and features in the embodiments of the present application can be combined with each other. It should also be noted that, for ease of description, only the parts related to the invention are shown in the drawings.

[0044] Embodiment 1:

[0045] like Figure 1-Figure 4 As shown, this embodiment provides an automated tester for bag-type plastic containers of human blood and blood components, including a plurality of test units, each of which can perform a test on a bag-type plastic container. This embodiment is specifically configured to include two test units, and in other embodiments, the number of test units can be increased.

[0046] Each of the test units includes a liquid injection part and a pressurizing part; the liquid injection part includes a liquid injection pump 14, the water inlet of the liquid injection pump 14 is connected to the water inlet tank, and the water inlet and outlet of the liquid injection pump 14 are respectively provided with solenoid valves 15; the pressurizing part includes a pressurizing base 7 and a pressure plate 6, the pressure plate 6 is located above the pressurizing base 7, and the pressure plate 6 is connected to a driving device 16 for driving it to press down and rise; the solenoid valve 15 is connected to a controller of the driving device 16.

[0047] Specifically, the driving device 16 is a pressurized cylinder, and the controller is provided by the pressurized cylinder. Controlling the cylinder through an electromagnetic valve is a technology that is well-known to those skilled in the art, and is not an innovative part of the present invention, and its specific setting method will not be repeated here.

[0048] The injection part and the pressurizing part are jointly arranged inside the shell 1, and the inside of the shell 1 is divided into three cavities from top to bottom. The driving device 16 is located in the top cavity 2, the pressurizing base 7 and the pressure plate 6 are located in the middle cavity 3, and the injection part is located in the bottom cavity 4. The actuating part of the driving device 16 extends into the middle cavity 3 and is connected to the pressure plate 6.

[0049] The housing 1 is provided with a water inlet / drain port 13 , and the water inlet pipe connecting the water inlet tank and the injection pump 14 and the liquid outlet pipe connecting the detected container can both enter and exit the housing 1 through the water inlet / drain port 13 .

[0050] Both the middle cavity 3 and the bottom cavity 4 are provided with openable doors, and a transparent plate 17 is provided on the door of the middle cavity 3 to facilitate operation, maintenance and observation of the equipment.

[0051] The test unit is equipped with a water outlet box, the water outlet box is connected to a liquid outlet pipeline, the liquid outlet pipeline is connected to the container to be tested, the container to be tested is connected to a pressure gauge 5, and the pressure gauge 5 is connected to the controller of the drive device 16. For easy observation, the pressure gauge 5 is installed on the housing 1. The pressure gauge 5 can be a Y-60 ordinary pressure gauge or a constant pressure pressure gauge. The pressure signal detected by the pressure gauge 5 is fed back to the controller of the drive device 16, and the controller controls the output component of the drive device 16 according to the pressure signal.

[0052] In this embodiment, two test units share one water inlet tank and one water outlet tank, making the structure of the instrument more compact and reducing the occupied space. When the number of test units increases, multiple test units can also share one water inlet tank and one water outlet tank.

[0053] This embodiment is also provided with one or more of the following signal feedback systems:

[0054] like Figure 7 As shown, the container 21 to be tested is a plastic blood bag. When conducting the test, the blood collection tube 22 is cut off and the pipeline is connected to the water outlet of the injection pump 14 for liquid inlet. A flow meter solenoid valve is set on the pipeline. The pressure gauge connecting pipe 24 is used to connect the pressure gauge 5. The pressure gauge 5 is placed on the shell 1 corresponding to the bottom cavity 4 and is used to detect the pressure inside the blood bag. The discharge port 23 is the blood transfusion socket of the blood bag. In actual use, this part will be connected to the blood transfusion device. When the blood transfusion device is connected during the test, the flow meter is connected. The flow meter detects the discharge flow of the blood bag. When the discharge flow is significantly reduced, it can be determined that the emptying is completed and the drive device 16 stops working.

[0055] A weighing device is provided below the pressurizing base 7, or is integrated into the pressurizing base 7, and is connected to the controller of the driving device 16. The blood bag is placed on the pressurizing base 7, and the weighing device weighs the weight change of the blood bag. The filling amount and the discharge amount can be obtained according to the weight change, so as to monitor whether it is empty. When the filling amount and the discharge amount are equal, it indicates that the detected container 21 is completely empty, and the driving device 16 stops working.

[0056] The pressurizing part is provided with a distance sensor for detecting the distance between the press plate 6 and the pressurizing base 7, and the distance sensor is connected to the controller of the driving device 16. The distance sensor can be a CMOS laser sensor of the LR-Z series. When the distance sensor detects that the distance between the press plate 6 and the pressurizing base 7 is equal to the thickness of the detected container 21, it indicates that the detected container is completely emptied, and the driving device 16 stops working.

[0057] The pressure gauge 5 connected to the detected container 21 can also realize the function of signal feedback. When the pressure gauge 5 detects that the outlet pressure drops to 0, it indicates that the detected container 21 is completely emptied and the driving device 16 stops working.

[0058] The above signal feedback systems can be set up at the same time, and the comprehensive measurement result is more accurate, or any one of them can be selected. Controlling the cylinder according to the feedback signal has many applications in the prior art, such as various automatic control cylinders on the market, and its specific setting method will not be repeated here.

[0059] After the pipeline is connected, place the container 21 to be tested on the pressurized base 7, start the injection pump 14 to fill the liquid, and generally fill 300ml or 500ml of the test liquid. The flow controller on the liquid inlet pipeline will detect the volume of the liquid filled. After the set volume of the test liquid is filled, the solenoid valve 15 is closed and the filling is stopped. The pipeline connected to the blood collection tube 22 and the pipeline connected to the discharge port 23 are both closed, and the drive device 16 drives the pressure plate 6 to press down to apply pressure to the container 21 to be tested. The pressure gauge 5 connected to the container 21 to be tested can detect the pressure inside the container 21 to be tested. The container 21 to be tested is squeezed between the pressure plate 6 and the pressurized base 7, so that its internal pressure rises to 50kPa higher than the atmospheric pressure. The anti-leakage test is carried out for 10 minutes, and no leakage should occur.

[0060] It should be noted that the container 21 to be tested is placed in the middle cavity 3 of the tester, and the pressure gauge 5 is set at the bottom cavity 4. Therefore, there is a height difference between the container 21 to be tested and the pressure gauge 5. According to the principle of fluid statics, there is a pressure difference between the heights of the two. For example, if the height difference between the two is 20 cm, the data displayed by the actual pressure gauge 5 is 2 kPa lower than the actual pressure inside the container 21 to be tested. According to this principle, the value of the pressure difference is obtained based on the height difference between the two to ensure the accuracy of applying pressure to the container 21 to be tested.

[0061] After the anti-leakage test is completed, the drain port 23 of the container 21 to be tested that has passed the anti-leakage test is opened and a pressurized emptying test is performed. The driving device 16 continues to pressurize the pressure plate 6 and the pressurized base 7 to squeeze the container 21 to be tested, maintaining its internal pressure higher than the atmospheric pressure by 50 kPa, and emptying it within 2 minutes without leakage.

[0062] During the pressurized emptying test, the pressure signal detected by the pressure gauge 5 is fed back to the controller of the driving device 16. The controller controls the output component of the driving device 16 according to the pressure signal. If the pressure drops, the downward pressure speed is accelerated so that the internal pressure of the container 21 to be tested is always maintained higher than the atmospheric pressure by 50 kPa during the entire experimental process until the end of the test. The judgment of the end of the test has been described in this embodiment and will not be repeated here.

[0063] In this embodiment, an external operation panel can be provided to facilitate the operation of the staff. The operation panel is configured as a button type or a touch screen type to perform operations such as filling, pressurizing, and emptying. The operation panel is widely used in existing equipment, and its specific configuration method will not be repeated here.

[0064] In order to meet the power supply and wiring requirements of the equipment, the shell is also provided with structures such as a junction box 9, an incoming line terminal 10, an outgoing line terminal 11, and an equipment inlet 12.

[0065] The automated tester of this embodiment is used to perform relevant tests at room temperature.

[0066] Embodiment 2:

[0067] The features of this embodiment that are the same as those of the first embodiment are not described in detail. The features of this embodiment that are different from the first embodiment are as follows: Figure 5 As shown, this embodiment only includes one test unit.

[0068] Embodiment three:

[0069] The features of this embodiment that are the same as those of the first embodiment are not described in detail. The features of this embodiment that are different from the first embodiment are as follows: Figure 6As shown, in this embodiment, the test unit is arranged in a temperature control box 18, and a refrigeration device is arranged in the temperature control box 18. The arrangement of the refrigeration device in the temperature control box 18 refers to the structure of a refrigerator, a beverage display cabinet, etc. in the prior art. A partition for carrying the test unit is arranged in the temperature control box 18. The test unit, the water inlet box 19, and the water outlet box 20 are all arranged in the temperature control box 18. The temperature control box 18 is provided with a door, preferably a double door, and a transparent plate is arranged on the door. For the convenience of expression, Figure 6 The door of the temperature control box 18 is not shown.

[0070] The temperature control box 18 can maintain a constant temperature environment inside. For soft polyvinyl chloride (PVC) blood bags, after conducting relevant tests at room temperature (23±5)°C, it is advisable to repeat the above tests at 4°C. At this time, the temperature control box 18 is used to achieve a constant temperature environment of 4°C.

[0071] In order to maintain the test temperature, the control button of the tester in this embodiment is externally connected to the outside of the instrument, or a remote-controlled liquid injection pump and a driving device are selected. The button external connection and remote control technology are existing mature technologies.

[0072] The above description is only a preferred embodiment of the present application and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the present application is not limited to the technical solution formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the inventive concept. For example, the above features are replaced with (but not limited to) technical features with similar functions disclosed in the present application.

[0073] Except for the technical features described in the specification, the remaining technical features are known technologies to those skilled in the art. In order to highlight the innovative features of the present invention, the remaining technical features will not be described here in detail.

Claims

1. An automated tester for human blood and blood component bag-type plastic containers, characterized in that: The test unit comprises one or more test units, each of which comprises a liquid injection part and a pressurizing part; the liquid injection part comprises a liquid injection pump, the water inlet of the liquid injection pump is connected to the water inlet tank, and the water inlet and the water outlet of the liquid injection pump are respectively provided with electromagnetic valves; the pressurizing part comprises a pressurizing base and a pressing plate, the pressing plate is located above the pressurizing base, and the pressing plate is connected to a driving device for driving it to press down and rise; the electromagnetic valve is connected to a controller of the driving device; The container to be tested is placed on a pressurized base, and a flow controller for detecting the volume of the liquid being flushed in is provided on the liquid inlet pipeline; The injection part and the pressurizing part are arranged together inside the shell, and the inside of the shell is divided into three chambers from top to bottom, the driving device is located in the top chamber, the pressurizing base and the pressing plate are located in the middle chamber, the injection part is located in the bottom chamber, and the action part of the driving device extends into the middle chamber and is connected to the pressing plate; The test unit is equipped with a water outlet box, the water outlet box is connected to a liquid outlet pipeline, the liquid outlet pipeline is connected to a detected container, the detected container is connected to a pressure gauge, and the pressure gauge is connected to a controller of the driving device.

2. The automatic tester for human blood and blood component bag-type plastic containers according to claim 1, characterized in that: The middle cavity and the bottom cavity are both provided with openable doors.

3. The automatic tester for human blood and blood component bag-type plastic containers according to claim 2, characterized in that: A transparent plate is arranged on the door of the middle cavity.

4. The automatic tester for human blood and blood component bag-type plastic containers according to claim 1, characterized in that: The test units are provided in plurality, and the plurality of test units share a water inlet tank and a water outlet tank.

5. The automatic tester for human blood and blood component bag-type plastic containers according to claim 1, characterized in that: The controller of the driving device is connected to a flow meter, and the flow meter is used to measure the discharge flow of the detected container.

6. The automatic tester for human blood and blood component bag-type plastic containers according to claim 1, characterized in that: A weighing device is arranged below the pressurizing base, and the weighing device is connected to the controller of the driving device.

7. The automatic tester for human blood and blood component bag-type plastic containers according to any one of claims 1, 5 or 6, characterized in that: The pressurizing part is provided with a distance sensor for detecting the distance between the press plate and the pressurizing base, and the distance sensor is connected to the controller of the driving device.

8. The automated tester for human blood and blood component bag-type plastic containers according to any one of claims 1 to 6, characterized in that: The test unit is arranged in a temperature control box, and a refrigeration device is arranged in the temperature control box.

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