Membrane oxygenator performance testing device and testing method

Abstract

This invention relates to a membrane oxygenator performance testing device and method. The membrane oxygenator performance testing device includes a gas input component and a liquid circulation component. The gas input component's outlet is connected to the membrane oxygenator's inlet to input gas into the membrane oxygenator. The liquid circulation component has a liquid outlet and a liquid return end; the liquid outlet is connected to the membrane oxygenator's liquid inlet, and the liquid return end is connected to the membrane oxygenator's liquid outlet. The liquid circulation component provides power to circulate liquid within the membrane oxygenator. The gas input component can adjust and acquire the gas pressure at the outlet; and / or, the liquid circulation component can adjust and acquire the hydraulic pressure at the outlet. The aforementioned membrane oxygenator performance testing device can test both its performance against gas burst pressure and its performance against liquid burst pressure.

Description

Technical Field

[0001] This invention relates to the field of membrane oxygenator performance testing technology, and in particular to a membrane oxygenator performance testing device and testing method. Background Technology

[0002] A membrane oxygenator, also known as a membrane artificial lung or oxygenation membrane, is a disposable artificial device that enables blood gas exchange. Based on the principle of alveolar gas exchange, it integrates oxygenation, temperature regulation, blood storage, and filtration functions to replace lung function in oxygenating the blood and removing carbon dioxide to meet the needs of patients during surgery. Oxygenation membranes currently mostly use a hollow fiber structure where gas flows through the inner cavity and blood flows through the outer layer. The principle is that when a partial pressure gradient exists between any gas components on both sides of the semi-permeable membrane, the corresponding gas molecules will diffuse from the side with higher partial pressure to the side with lower partial pressure, thereby achieving oxygenation of the blood and removal of CO2, regulating the O2 and CO2 levels in the blood.

[0003] Currently, there are no unified national standards for performance testing devices and testing methods for membrane oxygenators, and the testing methods and judgment criteria are still under exploration. Among them, resistance to gas burst pressure and resistance to blood burst pressure are two important mechanical properties of membrane oxygenators. The former characterizes the maximum pressure of gas passing through the membrane oxygenator under a certain blood pressure, while the latter characterizes the maximum pressure of blood passing through the membrane oxygenator under a certain gas pressure. Summary of the Invention

[0004] Based on this, the present invention provides a membrane oxygenator performance testing device and testing method to solve one or more technical problems in the prior art.

[0005] The technical solution is as follows: A membrane oxygenator performance testing device, wherein the membrane oxygenator includes a communicating air inlet and an air outlet, and a communicating liquid inlet and a liquid outlet, and the membrane oxygenator performance testing device includes:

[0006] A gas input assembly, comprising an outlet for communicating with the inlet to input gas to the membrane oxygenator; and

[0007] A liquid circulation assembly is provided with an outlet end and a return end. The outlet end is connected to the inlet end, and the return end is connected to the outlet end. The liquid circulation assembly can provide power to circulate liquid within the membrane oxygenator.

[0008] The gas input component can adjust and acquire the gas pressure at the gas outlet; and / or the liquid circulation component can adjust and acquire the hydraulic pressure at the liquid outlet.

[0009] In one embodiment, the gas input component includes a gas storage container, a first pipeline, a first switch, and a first pressure sensor; the gas storage container is connected to one end of the first pipeline, and the other end of the first pipeline is the gas outlet; the first switch is disposed on the first pipeline for adjusting the opening size of the first pipeline; the first pressure sensor is disposed near the gas outlet for obtaining the gas pressure at the gas outlet.

[0010] In one embodiment, the gas input component further includes a second switch and a second pressure sensor; the second switch is disposed near the gas storage container, and the second switch and the first switch are sequentially and spaced apart along the gas flow direction of the first pipeline; the second pressure sensor is disposed between the second switch and the first switch, and is used to obtain the gas pressure in the first pipeline corresponding to the section between the first switch and the second switch.

[0011] In one embodiment, the gas input assembly further includes a first controller; the first switch and the second switch are each independently selected from an electromagnetic control valve or a pneumatic control valve; the first controller is electrically connected to the first switch, the second switch, the first pressure sensor, and the second pressure sensor.

[0012] In one embodiment, the first controller is provided with a first display screen, which is used to display the air pressure value sensed by the first air pressure sensor and the rate of increase of the air pressure value sensed by the first air pressure sensor.

[0013] The first display screen is a touch screen; or, the first controller is provided with control buttons; or, the first controller is provided with a signal interface; or, the first controller is provided with a signal transceiver module.

[0014] In one embodiment, the membrane oxygenator performance testing device further includes a plug; the plug is detachably disposed at the air outlet of the membrane oxygenator.

[0015] In one embodiment, the liquid circulation assembly includes a second pipeline, a power pump, and a hydraulic sensor; the two ends of the second pipeline are the liquid outlet and the liquid return, respectively; the power pump is connected in series on the second pipeline, and the hydraulic sensor is used to sense the liquid pressure in the second pipeline.

[0016] In one embodiment, the liquid circulation assembly further includes a second controller; the power pump is a control pump, and the second controller is electrically connected to the power pump and the hydraulic sensor respectively.

[0017] In one embodiment, the liquid circulation assembly further includes a liquid storage tank and a temperature control module; the liquid storage tank is connected in series on the second pipeline; the temperature control module is used to heat the liquid to control the temperature of the liquid to a preset temperature; the temperature control module is electrically connected to the second controller.

[0018] In one embodiment, the second controller is provided with a second display screen; the second display screen is used to display the hydraulic value sensed by the hydraulic sensor, the rate of increase of the hydraulic value sensed by the hydraulic sensor, and the temperature of the liquid;

[0019] The second display screen is a touch screen; or, the second controller is equipped with control buttons; or, the second controller is equipped with a signal interface; or, the second controller is equipped with a signal transceiver module.

[0020] A method for testing the performance of a membrane oxygenator, the membrane oxygenator comprising an air inlet, an air outlet, a membrane cavity, a liquid inlet, a liquid outlet, and a main chamber, wherein the air inlet and the air outlet are connected to the membrane cavity, and the liquid inlet and the liquid outlet are connected to the main chamber; the method for testing the performance of the membrane oxygenator includes the following steps:

[0021] The gas burst pressure resistance test procedure involves: introducing liquid at a first preset pressure into the main chamber through the inlet; blocking the outlet and introducing gas into the membrane cavity through the inlet, while gradually increasing the gas pressure entering the inlet; when the first continuous bubble is observed at the outlet, acquiring the gas pressure entering the inlet and using this gas pressure as the gas burst pressure; and / or,

[0022] The liquid burst pressure resistance test procedure involves introducing gas at a second preset pressure into the membrane cavity through the air inlet; introducing liquid into the main chamber through the liquid inlet, and gradually increasing the liquid pressure entering the liquid inlet; when continuous droplets are observed to be generated at the air outlet, the liquid pressure at the liquid inlet is taken as the liquid burst pressure resistance.

[0023] In one embodiment, in the gas explosion pressure test step, the step of gradually increasing the gas pressure entering the inlet includes: increasing the gas pressure in the inlet to the initial gas pressure, and increasing the gas pressure in the inlet at a first rate of increase based on the initial gas pressure.

[0024] In the liquid burst pressure test step, the step of gradually increasing the liquid pressure entering the inlet of the membrane oxygenator includes: increasing the liquid pressure at the inlet to the initial hydraulic pressure, and increasing the liquid pressure at the inlet at a second rising rate based on the initial hydraulic pressure.

[0025] In one embodiment, the initial air pressure is less than the first preset pressure, and the first rising speed is 0.01-0.05 MPa / min; the initial hydraulic pressure is less than the second preset pressure, and the second rising speed is 0.01-0.05 MPa / min.

[0026] In one embodiment, the first preset pressure is 0.01-1 MPa, and the second preset pressure is 0.01-1 MPa.

[0027] In one embodiment, during the gas burst pressure test step and / or the liquid burst pressure test step, the temperature of the liquid input into the main chamber is 36°C to 38°C.

[0028] The aforementioned membrane oxygenator performance testing device, when performing a gas explosion pressure test, uses a liquid circulation component to power the liquid circulation flow within the main chamber of the membrane oxygenator. It controls the hydraulic pressure at the outlet end entering the inlet of the membrane oxygenator to a first preset pressure. Simultaneously, for example, the outlet of the membrane oxygenator is blocked, and gas is introduced into the membrane chamber through a gas input component. The gas pressure entering the inlet is gradually increased. When the first continuous bubble is observed at the outlet of the membrane oxygenator, the gas pressure at the outlet end is recorded by the gas input component. The pressure at the gas explosion resistance is used as the test pressure. When a liquid explosion resistance test is required, gas is introduced into the membrane chamber of the membrane oxygenator through the gas input component, and the gas pressure entering the inlet of the membrane oxygenator is controlled to be at a second preset pressure. Simultaneously, the liquid circulation component provides power to circulate liquid within the main chamber of the membrane oxygenator, and the hydraulic pressure at the outlet end entering the inlet of the membrane oxygenator is gradually increased. When continuous droplets are observed at the outlet of the membrane oxygenator, the liquid pressure at the outlet end obtained by the liquid circulation component is taken as the liquid explosion resistance pressure. Therefore, the above-described membrane oxygenator performance testing device can test both gas explosion resistance and liquid explosion resistance performance.

[0029] The above-mentioned performance testing method for membrane oxygenators can be used to test their performance against gas burst pressure and / or their performance against liquid burst pressure. Attached Figure Description

[0030] The accompanying drawings, which form part of this application, are used to provide a further understanding of the invention. The illustrative embodiments of the invention and their descriptions are used to explain the invention and do not constitute an improper limitation of the invention.

[0031] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0032] Figure 1 This is a schematic diagram of the structure of a membrane oxygenator according to an embodiment of the present invention;

[0033] Figure 2 This is a schematic diagram of the structure of a membrane oxygenator performance testing device according to an embodiment of the present invention.

[0034] 10. Membrane oxygenator; 11. Membrane housing; 111. Air inlet; 112. Air outlet; 113. Liquid inlet; 114. Liquid outlet; 115. First end; 116. Second end; 12. Membrane fiber; 13. First sealing layer; 14. Second sealing layer; 15. First chamber; 16. Second chamber; 17. Main chamber; 20. Gas input assembly; 21. Gas storage container; 22. First pipeline; 221. Air outlet; 23. First switch; 24. First pressure sensor; 25. Second switch; 26. Second pressure sensor; 27. First controller; 30. Liquid circulation assembly; 31. Second pipeline; 311. Liquid outlet; 312. Liquid return; 32. Constant temperature and pressure circulation control box; 321. Second display screen; 33. Third switch; 40. Plug. Detailed Implementation

[0035] To make the above-mentioned objects, features, and advantages of the present invention more apparent and understandable, specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of the present invention. However, the present invention can be practiced in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the present invention. Therefore, the present invention is not limited to the specific embodiments disclosed below.

[0036] See Figure 1 , Figure 1A schematic diagram of a membrane oxygenator 10 according to an embodiment of the present invention is shown. The membrane oxygenator 10 includes a membrane shell 11; one or more membrane filaments 12 disposed within the membrane shell 11, the extending direction of the membrane filaments 12 being consistent with the radial direction of the membrane shell 11; and a first sealing layer 13 and a second sealing layer 14 disposed within the membrane shell 11 and disposed opposite to each other at both ends of the membrane filaments 12, the first sealing layer 13 and the second sealing layer 14 being perpendicular to the extending direction of the membrane filaments 12. Further, the membrane shell 11 also includes a first end 115 and a second end 116 located at both ends. A first chamber 15 is formed between the first sealing layer 13 and the first end 115 of the membrane shell 11, and the first end 115 of the membrane shell 11 is also provided with an air inlet 111 communicating with the first chamber 15. A second chamber 16 is formed between the second sealing layer 14 and the second end 116 of the membrane shell 11, and the second end 116 of the membrane shell 11 is also provided with an air outlet 112 communicating with the second chamber 16. One end of all membrane fibers 12 passes through the first sealing layer 13 and communicates with the first chamber 15, while the other end of all membrane fibers 12 passes through the second sealing layer 14 and communicates with the second chamber 16. Furthermore, the first sealing layer 13, the second sealing layer 14, and the membrane shell 11 enclose a main chamber 17. The wall of the membrane shell 11 is provided with an inlet 113 and an outlet 114 that communicate with the main chamber 17.

[0037] See Figure 1 and Figure 2 , Figure 2 A schematic diagram of a performance testing device for a membrane oxygenator 10 according to an embodiment of the present invention is shown. The membrane oxygenator 10 performance testing device provided by this embodiment includes a gas input component 20 and a liquid circulation component 30. The gas input component 20 includes an outlet end 221, which is connected to the inlet 111 of the membrane oxygenator 10 to input gas into the membrane oxygenator 10. The liquid circulation component 30 has a liquid outlet end 311 and a liquid return end 312. The liquid outlet end 311 is connected to the liquid inlet 113 of the membrane oxygenator 10, and the liquid return end 312 is connected to the liquid outlet 114 of the membrane oxygenator 10. The liquid circulation component 30 provides power to circulate liquid within the membrane oxygenator 10. The gas input component 20 can adjust and obtain the gas pressure at the gas outlet 221; and / or the liquid circulation component 30 can adjust and obtain the hydraulic pressure at the liquid outlet 311.

[0038] In the aforementioned performance testing device for the membrane oxygenator 10, when a gas explosion pressure test is required, the liquid circulation component 30 provides power to circulate liquid within the main chamber 17 of the membrane oxygenator 10, and controls the hydraulic pressure at the outlet 311 entering the inlet 113 of the membrane oxygenator 10 to be at a first preset pressure. Simultaneously, for example, the outlet 112 of the membrane oxygenator 10 is blocked, and gas is input into the membrane cavity of the membrane oxygenator 10 through the gas input component 20. The gas pressure entering the inlet 111 of the membrane oxygenator 10 is gradually increased. When the first continuous bubble is observed at the outlet 114 of the membrane oxygenator 10, the gas pressure at the outlet 22 obtained by the gas input component 20 is recorded. The gas pressure of 1 is used as the resistance to gas explosion pressure. When liquid explosion pressure resistance testing is required, gas is input into the membrane cavity of the membrane oxygenator 10 through the gas input component 20, and the gas pressure entering the air inlet 111 of the membrane oxygenator 10 is controlled to be at a second preset pressure. At the same time, the liquid circulation component 30 provides power to make the liquid circulate in the main chamber 17 of the membrane oxygenator 10, and the hydraulic pressure entering the liquid inlet 113 of the membrane oxygenator 10 through the liquid outlet 311 is controlled to gradually increase. When continuous droplets are observed to be generated at the air outlet 112 of the membrane oxygenator 10, the liquid pressure at the liquid outlet 311 obtained by the liquid circulation component 30 is used as the resistance to liquid explosion pressure. Thus, it can be seen that the above-mentioned membrane oxygenator 10 performance testing device can test both the performance resistance to gas explosion pressure and the performance resistance to liquid explosion pressure.

[0039] It should be noted that the gas in this embodiment includes, but is not limited to, oxygen, and may also be other types of gas. No limitation is made here, and it can be set according to actual needs.

[0040] It should also be noted that the liquid in this embodiment includes, but is not limited to, blood and plasma substitutes, and may also be other liquids. No limitation is made here; the choice can be made according to actual needs. When plasma substitutes are used, this includes, but is not limited to, solutions prepared with a concentration of 1.5g / 500ml lecithin and 0.9% physiological saline.

[0041] Please see Figure 1 and Figure 2In one embodiment, the gas input component 20 includes a gas storage container 21, a first pipeline 22, a first switch 23, and a first pressure sensor 24. The gas storage container 21 is connected to one end of the first pipeline 22, and the other end of the first pipeline 22 is a gas outlet 221. The first switch 23 is disposed on the first pipeline 22 and is used to adjust the opening size of the first pipeline 22. The first pressure sensor 24 is disposed near the gas outlet 221 and is used to obtain the gas pressure at the gas outlet 221. Thus, the gas storage container 21 inputs gas into the membrane cavity of the membrane oxygenator 10 through the first pipeline 22. When, for example, a gas explosion pressure test is performed, by adjusting the opening of the first switch 23 and obtaining the gas pressure at the outlet 221 through the first pressure sensor 24, the gas pressure at the outlet 221 of the gas input component 20 can be adjusted to a preset value, and the gas pressure entering the inlet 111 of the membrane oxygenator 10 can be gradually increased. When, for example, a liquid explosion pressure test is performed, by adjusting the opening of the first switch 23 and obtaining the gas pressure at the outlet 221 through the first pressure sensor 24, the gas pressure at the outlet 221 of the gas input component 20 can be adjusted to a preset value.

[0042] As an example, the gas storage container 21 may include, but is not limited to, oxygen cylinders or oxygen tanks, and may also be a container for storing other gases, depending on actual needs.

[0043] Please see Figure 1 and Figure 2 In one embodiment, the gas input component 20 further includes a second switch 25 and a second pressure sensor 26. The second switch 25 is disposed on the first pipeline 22, near the gas storage container 21. The second switch 25 and the first switch 23 are sequentially and spaced apart along the gas flow direction of the first pipeline 22. The second pressure sensor 26 is disposed between the second switch 25 and the first switch 23, and is used to obtain the gas pressure in the section of the first pipeline 22 corresponding to the section between the first switch 23 and the second switch 25. Thus, by disposing of the second switch 25 and the second pressure sensor 26 on the first pipeline 22, by adjusting the opening of the second switch 25 and according to the gas pressure sensed by the second pressure sensor 26, the gas pressure in the section of the first pipeline 22 corresponding to the section between the first switch 23 and the second switch 25 can be controlled at a preset value. This preset value is less than the gas pressure stored inside the gas storage container 21, thus acting as a buffer and allowing for better adjustment of the gas pressure at the outlet 221.

[0044] Please see Figure 1 and Figure 2In one embodiment, the gas input assembly 20 further includes a first controller 27. The first switch 23 and the second switch 25 are both electromagnetic control valves or pneumatic control valves. The first controller 27 is electrically connected to the first switch 23, the second switch 25, the first pressure sensor 24, and the second pressure sensor 26, respectively. Thus, the first controller 27 obtains the air pressure at the outlet 221 sensed by the first pressure sensor 24, and adjusts the first switch 23 and / or the second switch 25 accordingly based on the air pressure sensing signal from the first pressure sensor 24, thereby effectively adjusting the air pressure at the outlet 221. Furthermore, the first controller 27 obtains the air pressure at the pipe section between the first switch 23 and the second switch 25 sensed by the second pressure sensor 26, and adjusts the second switch 25 accordingly based on the air pressure sensing signal from the second pressure sensor 26, thereby effectively adjusting the air pressure at the pipe section between the first switch 23 and the second switch 25.

[0045] Of course, as an alternative, both the first switch 23 and the second switch 25 can be manual regulating valves, and the air pressure can be adjusted by manually adjusting the opening of the first switch 23 and the second switch 25.

[0046] Please see Figure 1 and Figure 2 In one embodiment, the first controller 27 is equipped with a first display screen, which displays the air pressure value sensed by the first air pressure sensor 24, as well as the rate of increase of the air pressure value sensed by the first air pressure sensor 24. Thus, during testing, the first display screen can promptly display the air pressure value sensed by the first air pressure sensor 24, and also display the rate of increase of the air pressure value. This allows operators to better grasp and adjust the air pressure at the outlet 221, and also to simultaneously obtain the magnitude of the gas burst pressure by observing the first display screen when the first continuous bubble is observed at the liquid outlet 114 of the membrane oxygenator 10.

[0047] Please see Figure 1 and Figure 2 In order to set relevant air pressure parameters in the first controller 27, in one embodiment, the first display screen is a touch screen; or, the first controller 27 is provided with control buttons; or, the first controller 27 is provided with a signal interface; or, the first controller 27 is provided with a signal transceiver module.

[0048] Please see Figure 1 and Figure 2In one embodiment, the performance testing device for the membrane oxygenator 10 further includes a plug 40. The plug 40 is detachably disposed at the outlet 112 of the membrane oxygenator 10. Thus, when a gas burst pressure test is required, the outlet 112 of the membrane oxygenator 10 is sealed by the plug 40. Furthermore, when a liquid burst pressure test is required, the plug 40 is opened, for example, and gas at a preset pressure is introduced into the membrane cavity through the inlet 111 of the membrane oxygenator 10. It is understood that the plug 40 can also be omitted, and other separable components can be used to seal the outlet 112 during operation; this is not limited here, and the configuration can be based on actual needs.

[0049] Please see Figure 1 and Figure 2 In one embodiment, the liquid circulation assembly 30 includes a second pipeline 31, a power pump (not shown), and a hydraulic sensor (not shown). The two ends of the second pipeline 31 are an outlet end 311 and a return end 312, respectively. The power pump is connected in series to the second pipeline 31 and can provide a preset pressure to drive the liquid circulation. When the power pump adjusts its operating power, the liquid pressure at the outlet end 311 can be adjusted accordingly. The hydraulic sensor is used to sense the liquid pressure in the second pipeline 31.

[0050] Please see Figure 1 and Figure 2 In one embodiment, the liquid circulation assembly 30 further includes a second controller (not shown in the figure). The power pump is a control pump, and the second controller is electrically connected to both the power pump and the hydraulic sensor. Thus, the second controller adjusts the operating power of the power pump according to the liquid pressure sensed by the hydraulic sensor, so that the pressure at the outlet 311 reaches a preset value, resulting in a high degree of automation.

[0051] As an alternative, the power pump is not limited to a control pump; it can also be a manual pump, which provides power manually to drive the liquid circulation.

[0052] Please see Figure 1 and Figure 2 In one embodiment, the liquid circulation assembly 30 further includes a liquid storage tank (not shown) and a temperature control module (not shown). The liquid storage tank is connected in series to the second pipeline 31. The temperature control module senses the temperature of the liquid and heats the liquid to control the liquid temperature at a preset temperature. The temperature control module is electrically connected to a second controller. Thus, by controlling the liquid temperature within a preset range, such as 36°C to 38°C, specifically 37°C, the performance testing of the membrane oxygenator 10 can be made more accurate and reliable.

[0053] It should be noted that the temperature control module is used to heat liquids, including but not limited to being connected in series on the second pipeline 31, and its specific configuration does not need to be limited.

[0054] See Figure 1 and Figure 2 In one embodiment, the second controller is equipped with a second display screen 321. The second display screen 321 displays the hydraulic pressure value sensed by the hydraulic sensor, the rate of increase of the hydraulic pressure value sensed by the hydraulic sensor, and the temperature of the liquid. Thus, during testing, the second display screen 321 can promptly display the hydraulic pressure value sensed by the hydraulic sensor and also display the rate of increase of the hydraulic pressure value. This allows the operator to better grasp and adjust the hydraulic pressure at the outlet 311, and also allows them to simultaneously observe the magnitude of the liquid burst pressure by observing the second display screen 321 when continuous droplets are observed at the outlet 112 of the membrane oxygenator 10.

[0055] See Figure 1 and Figure 2 In order to set relevant hydraulic parameters in the second controller, in one embodiment, the second display screen 321 is a touch screen, through which relevant hydraulic parameters can be input; or, the second controller is provided with control buttons, through which relevant hydraulic parameters can be input and set; or, the second controller is provided with a signal interface, through which relevant hydraulic parameters can be input and set by connecting an external input device to the signal interface; or, the second controller is provided with a signal transceiver module, through which relevant hydraulic parameters can be input and set by connecting an external input device to the signal transceiver module.

[0056] See Figure 1 and Figure 2 In one specific embodiment, the power pump, hydraulic sensor, temperature control module, and second controller are all integrated into the liquid storage tank, thereby forming an integrated constant temperature and pressure circulation control box 32.

[0057] See Figure 1 and Figure 2 In one embodiment, the liquid circulation assembly 30 further includes a third switch 33 disposed on the outlet end 311 of the second pipeline 31. The third switch 33 is used to adjust the opening size of the second pipeline 31, thereby correspondingly adjusting the hydraulic pressure entering the inlet 113 of the membrane oxygenator 10 from the outlet end 311. Furthermore, after the test is completed, the third switch 33 is closed, so that liquid no longer enters the interior of the membrane oxygenator 10. Specifically, the third switch 33 is an electromagnetic control valve or a pneumatic control valve, and the third switch 33 is electrically connected to the second controller.

[0058] See Figure 1 and Figure 2In one embodiment, a method for testing the performance of a membrane oxygenator 10 is provided. The membrane oxygenator 10 includes an air inlet, an air outlet, a membrane cavity, a liquid inlet, a liquid outlet, and a main chamber. The air inlet and the air outlet are connected to the membrane cavity, and the liquid inlet and the liquid outlet are connected to the main chamber. The interior of the membrane fibers forms the membrane cavity, and the space between the exterior of the membrane fibers and the membrane shell forms the main chamber. The membrane cavity and the auxiliary chamber are separated by a hollow fiber membrane. The method for testing the performance of the membrane oxygenator 10 includes the following steps:

[0059] The gas explosion resistance pressure test procedure involves: introducing liquid at a first preset pressure into the main chamber 17 of the membrane oxygenator 10 through the inlet 113; blocking the outlet 112 of the membrane oxygenator 10; introducing gas into the membrane cavity of the membrane oxygenator 10 through the inlet 111; and gradually increasing the gas pressure entering the inlet 111; when the first continuous bubble is observed to be generated at the outlet 114 of the membrane oxygenator 10; obtaining the gas pressure entering the inlet 111 of the membrane oxygenator 10; and using the gas pressure at the inlet 111 of the membrane oxygenator 10 as the gas explosion resistance pressure; and / or,

[0060] The liquid burst pressure resistance test procedure involves introducing gas at a second preset pressure into the membrane cavity of the membrane oxygenator 10 through the air inlet 111; introducing liquid into the main chamber 17 of the membrane oxygenator 10 through the liquid inlet 113, and gradually increasing the liquid pressure entering the liquid inlet 113; when continuous droplets are observed to be generated at the air outlet 112 of the membrane oxygenator 10, the liquid pressure at the liquid inlet 113 is taken as the liquid burst pressure resistance.

[0061] The above-mentioned performance test method for the membrane oxygenator 10 can be used to test its performance against gas burst pressure and / or its performance against liquid burst pressure.

[0062] It should be noted that the first continuous bubble refers to the first two bubbles that appear together during the process of the liquid outlet 114 of the membrane oxygenator 10 discharging bubbles.

[0063] In one embodiment, the step of gradually increasing the gas pressure entering the inlet 111 of the membrane oxygenator 10 during the gas explosion pressure test includes: increasing the gas pressure at the inlet 111 of the membrane oxygenator 10 to the initial gas pressure, and then increasing the gas pressure at the inlet 111 at a first rate of increase based on the initial gas pressure. Specifically, the initial gas pressure is not limited to 0.08 MPa, as long as it is less than a first preset pressure, and the first rate of increase is not limited to 0.01-0.05 MPa / min. Thus, during the gas explosion pressure test, the initial gas pressure can be rapidly increased to, but is not limited to, 0.08 MPa, and then, starting from the initial gas pressure, the gas pressure can be increased at a first rate of increase, for example, 0.01 MPa / min. This ensures both the performance testing effect of the membrane oxygenator 10 and the testing efficiency.

[0064] In one embodiment, the step of gradually increasing the liquid pressure entering the inlet 113 of the membrane oxygenator 10 during the liquid burst pressure test includes: increasing the liquid pressure at the inlet 113 of the membrane oxygenator 10 to the initial hydraulic pressure, and then increasing the liquid pressure at the inlet 113 at a second increasing rate based on the initial hydraulic pressure. Specifically, the initial hydraulic pressure includes, but is not limited to, 0.1 MPa, as long as it is less than a second preset pressure, and the second increasing rate is 0.01-0.05 MPa / min. Thus, during the liquid burst pressure test, the initial hydraulic pressure can be rapidly increased to, for example, 0.1 MPa, and then, starting from the initial hydraulic pressure, the liquid pressure can be increased at a second increasing rate, for example, 0.01 MPa / min. This ensures both the performance testing effect of the membrane oxygenator 10 and the testing efficiency.

[0065] In one embodiment, the first preset pressure is 0.01-1 MPa, and the second preset pressure is 0.01-1 MPa. For example, the first preset pressure is 0.1 MPa, and the second preset pressure is 0.1 MPa.

[0066] In one embodiment, during the gas burst pressure test step and / or the liquid burst pressure test step, the liquid temperature input into the main chamber 17 of the membrane oxygenator 10 is controlled to be between 36°C and 38°C.

[0067] To make the present invention clearer, see [reference] Figure 1 and Figure 2 The following describes in detail a specific embodiment of a membrane oxygenator 10 performance testing method, using the membrane oxygenator 10 performance testing device of any of the above embodiments, including the following steps:

[0068] The gas burst pressure test procedure involves adding a plasma substitute (a solution prepared with 1.5g / 500ml lecithin and 0.9% physiological saline) to a constant temperature and pressure circulating control chamber 32. The solution temperature is set to 37℃, and the first preset pressure is set to 0.1MPa. The outlet 112 of the membrane oxygenator 10 assembly is sealed with a plug 40. The second switch 25 of the gas storage container 21 is opened. The initial gas pressure is set to 0.08MPa on the first display screen, and the first rising rate is 0.01MPa / min. All equipment and devices are operated, and the gas pressure inside the membrane filament 12 rises at a rate of 0.01MPa / min. When the gas pressure increases to, for example, 0.14MPa, continuous bubbles are clearly observed at the outlet 114 of the membrane oxygenator 10 assembly. This 0.14MPa pressure is the gas burst pressure.

[0069] The liquid burst pressure test procedure involves adding a plasma substitute (a solution prepared with 1.5g / 500ml lecithin and 0.9% physiological saline) to a constant temperature and pressure circulating control chamber 32. The solution temperature is set to 37°C, the initial hydraulic pressure is set to 0.1MPa, and the second rising rate is set to 0.01MPa / min. The second switch 25 and the first switch 23 of the gas storage container 21 are opened, and the second preset pressure is set to 0.1MPa on the first display screen. All equipment and devices are operated, and the liquid pressure inside the membrane filament 12 rises at a rate of 0.01MPa / min. When the liquid pressure increases to, for example, 0.18MPa, and continuous droplets are observed at the outlet 112 of the membrane oxygenator 10, this pressure of 0.18MPa is the liquid burst pressure.

[0070] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0071] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

[0072] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention 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 invention.

[0073] Furthermore, 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 at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0074] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0075] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0076] It should be noted that when an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening element. When an element is considered to be "connected to" another element, it can be directly connected to the other element or there may be an intervening element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only possible implementation.

Claims

1. A method for testing the performance of a membrane oxygenator, the membrane oxygenator comprising an air inlet, an air outlet, a membrane cavity, a liquid inlet, a liquid outlet, and a main chamber, wherein the air inlet and the air outlet are connected to the membrane cavity, and the liquid inlet and the liquid outlet are connected to the main chamber; characterized in that, The membrane oxygenator performance testing method employs a membrane oxygenator performance testing device, which includes: A gas input assembly, comprising an outlet for communicating with the inlet to input gas to the membrane oxygenator; and A liquid circulation assembly is provided with an outlet end and a return end. The outlet end is connected to the inlet end, and the return end is connected to the outlet end. The liquid circulation assembly is used to provide power to circulate liquid in the membrane oxygenator. Wherein, the gas input component can adjust and acquire the gas pressure at the gas outlet; and / or, the liquid circulation component can adjust and acquire the hydraulic pressure at the liquid outlet; The performance testing method for the membrane oxygenator includes the following steps: The gas burst pressure resistance test procedure involves: introducing liquid at a first preset pressure into the main chamber through the inlet; blocking the outlet and introducing gas into the membrane cavity through the inlet, while gradually increasing the gas pressure entering the inlet; when the first continuous bubble is observed at the outlet, acquiring the gas pressure entering the inlet and using this gas pressure as the gas burst pressure; and / or, The liquid burst pressure resistance test procedure involves introducing gas at a second preset pressure into the membrane cavity through the air inlet; introducing liquid into the main chamber through the liquid inlet, and gradually increasing the liquid pressure entering the liquid inlet; when continuous droplets are observed to be generated at the air outlet, the liquid pressure at the liquid inlet is taken as the liquid burst pressure resistance.

2. The method for testing the performance of a membrane oxygenator according to claim 1, characterized in that, In the gas explosion pressure test step, the step of controlling the gas pressure entering the air inlet to gradually increase includes: increasing the gas pressure in the air inlet to the initial gas pressure, and increasing the gas pressure in the air inlet at a first rate of increase based on the initial gas pressure. In the liquid burst pressure test step, the step of gradually increasing the liquid pressure entering the inlet of the membrane oxygenator includes: increasing the liquid pressure at the inlet to the initial hydraulic pressure, and increasing the liquid pressure at the inlet at a second rising rate based on the initial hydraulic pressure.

3. The method for testing the performance of a membrane oxygenator according to claim 2, characterized in that, The initial air pressure is less than the first preset pressure, and the first rising speed is 0.01-0.05 MPa / min; the initial hydraulic pressure is less than the second preset pressure, and the second rising speed is 0.01-0.05 MPa / min.

4. The method for testing the performance of a membrane oxygenator according to claim 3, characterized in that, The first preset pressure is 0.01-1 MPa, and the second preset pressure is 0.01-1 MPa.

5. The method for testing the performance of a membrane oxygenator according to claim 1, characterized in that, In the gas burst pressure test step and / or liquid burst pressure test step, the liquid temperature input into the main chamber is 36°C to 38°C.

6. The method for testing the performance of a membrane oxygenator according to claim 1, characterized in that, The gas input component includes a gas storage container, a first pipeline, a first switch, and a first pressure sensor; the gas storage container is connected to one end of the first pipeline, and the other end of the first pipeline is the gas outlet; the first switch is disposed on the first pipeline and is used to adjust the opening size of the first pipeline. The first air pressure sensor is located near the air outlet and is used to obtain the air pressure at the air outlet.

7. The method for testing the performance of a membrane oxygenator according to claim 6, characterized in that, The gas input component further includes a second switch and a second pressure sensor; the second switch is disposed near the gas storage container, and the second switch and the first switch are sequentially and alternately disposed on the first pipeline along the gas flow direction of the first pipeline; The second pressure sensor is disposed between the second switch and the first switch, and is used to obtain the pressure of the pipe section in the first pipeline corresponding to the section between the first switch and the second switch.

8. The method for testing the performance of a membrane oxygenator according to claim 7, characterized in that, The gas input assembly further includes a first controller; the first switch and the second switch are each independently selected from an electromagnetic control valve or a pneumatic control valve; the first controller is electrically connected to the first switch, the second switch, the first pressure sensor, and the second pressure sensor respectively.

9. The method for testing the performance of a membrane oxygenator according to claim 8, characterized in that, The first controller is equipped with a first display screen, which is used to display the air pressure value sensed by the first air pressure sensor, and to display the rate of increase of the air pressure value sensed by the first air pressure sensor. The first display screen is a touch screen; or, the first controller is provided with control buttons; or, the first controller is provided with a signal interface; or, the first controller is provided with a signal transceiver module.

10. The method for testing the performance of a membrane oxygenator according to claim 1, characterized in that, The membrane oxygenator performance testing device also includes a plug; the plug is detachably disposed at the air outlet of the membrane oxygenator.

11. The method for testing the performance of a membrane oxygenator according to claim 1, characterized in that, The liquid circulation assembly includes a second pipeline, a power pump, and a hydraulic sensor; the two ends of the second pipeline are the liquid outlet and the liquid return, respectively; the power pump is connected in series on the second pipeline, and the hydraulic sensor is used to sense the liquid pressure in the second pipeline.

12. The method for testing the performance of a membrane oxygenator according to claim 11, characterized in that, The liquid circulation assembly also includes a second controller; the power pump is a control pump, and the second controller is electrically connected to the power pump and the hydraulic sensor respectively.

13. The method for testing the performance of a membrane oxygenator according to claim 12, characterized in that, The liquid circulation assembly further includes a liquid storage tank and a temperature control module; the liquid storage tank is connected in series on the second pipeline; the temperature control module is used to heat the liquid to control the temperature of the liquid to a preset temperature; the temperature control module is electrically connected to the second controller.

14. The method for testing the performance of a membrane oxygenator according to claim 13, characterized in that, The second controller is equipped with a second display screen; the second display screen is used to display the hydraulic value sensed by the hydraulic sensor, the rate of increase of the hydraulic value sensed by the hydraulic sensor, and the temperature of the liquid; The second display screen is a touch screen; or, the second controller is equipped with control buttons; or, the second controller is equipped with a signal interface; or, the second controller is equipped with a signal transceiver module.

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