Membrane oxygenator gas exchange performance in-vitro testing device
By designing an in vitro test device for membrane oxygenators, the deoxygenation and oxygenation cycle is achieved using the blood storage container, the problem of excessive blood use and inability to test commercial oxygenators is solved, and efficient and accurate gas exchange performance testing is achieved.
Patent Information
- Application Number
- CN202510071713.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-01-16
- Publication Date
- 2025-05-27
AI Technical Summary
In the prior art, when testing the gas exchange performance of membrane oxygenators, the blood usage is too large and can only be tested with a smaller oxygenation area, and the performance of commercial oxygenators cannot be effectively evaluated.
A membrane oxygenator gas exchange performance in vitro test device is designed, and the first blood storage container and the second blood storage container are used to collect deoxygenated blood and oxygenated blood. The deoxygenated oxygenation cycle operation is realized through the on-off connection, saving blood volume and improving the test accuracy.
Through this device, blood usage can be effectively saved, the accuracy and efficiency of the test can be improved, and the gas exchange performance of commercial oxygenators with large oxygenation areas can be evaluated.
Smart Images
Figure CN120037486A_ABST
Abstract
Description
Technical Field
[0001] The invention relates to the technical field of medical device detection, and in particular to an in vitro testing device for gas exchange performance of a membrane oxygenator. Background Art
[0002] Oxygenator, also known as artificial lung, is a microporous hollow fiber oxygenator that can replace the gas transfer function of the lungs and treat patients with respiratory failure. It has important applications in the treatment of acute respiratory diseases, cardiovascular surgery and waiting for lung transplantation. Its main working principle is to oxygenate and remove carbon dioxide from the body's venous blood in the membrane oxygenator, thus turning it into arterial blood, which is then transfused back into the patient's body to maintain the supply of oxygenated blood to the body's organs and tissues.
[0003] The gas exchange performance of the membrane oxygenator is its key core performance and a key indicator for evaluating its effective oxygenation and removal of carbon dioxide in extracorporeal circulation. At present, the gas exchange performance of the oxygenator is mainly tested by in vivo animal experiments and in vitro experiments. The in vivo animal experiments are subject to individual differences in animals, and the repeatability of the experimental results is low; the in vitro experiment first needs to refer to the standard ISO7199 to adjust the ex vivo blood to a standard state (blood oxygen saturation (65±5)% and carbon dioxide partial pressure (6.0±0.7) kPa range), and then pass the adjusted blood into the membrane oxygenator to be evaluated for testing. In vitro experiments include continuous tests and discontinuous tests. The discontinuous test process requires the consumption of a large amount of blood and has a high test cost; the continuous test can only test test components with a small oxygenation area due to the low deoxygenation efficiency of the deoxygenator, and cannot test the currently commercially available oxygenators. Summary of the invention
[0004] The present application aims to solve at least one of the technical problems existing in the related art. To this end, the present application proposes an in vitro test device for gas exchange performance of a membrane oxygenator, which is used to overcome the defects of excessive blood usage during the test of gas exchange performance of a membrane oxygenator and the test circuit being able to test only test components with a smaller oxygenation area.
[0005] The in vitro test device for gas exchange performance of a membrane oxygenator according to an embodiment of the present application comprises a first blood storage container, a second blood storage container, a first heater, a second heater, a driving pump, a deoxygenator, a deoxygenation source, an oxygen filling source and an oxygenator to be evaluated; The inlet of the driving pump is connected to the first blood storage container, the outlet of the driving pump can be connected and disconnected to the deoxygenator and the oxygenator to be evaluated, the inlet of the first blood storage container can be connected and disconnected to the blood outlet of the deoxygenator; the first heater is connected to the heat exchange channel of the deoxygenator; the deoxygenated gas source is connected to the gas inlet of the deoxygenator; the blood outlet of the oxygenator to be evaluated can be connected and disconnected to the first blood storage container and the second blood storage container, and the outlet of the second blood storage container can be connected and disconnected to the inlet of the first blood storage container; the second heater is connected to the heat exchange channel of the oxygenator to be evaluated; the oxygen filling source is connected to the gas inlet of the oxygenator to be evaluated.
[0006] The in vitro test device for gas exchange performance of a membrane oxygenator of the present application adopts a first blood storage container and a second blood storage container to collect deoxygenated blood and oxygenated blood, thereby solving the problem that deoxygenated and oxygenated blood are mixed when one blood storage container is used during the test, causing inconsistent blood conditions during the test, thereby improving the accuracy of the test; one of the first blood storage container and the second blood storage container is connected in an on-off manner in the oxygenation circuit to collect oxygenated blood, and can be connected after the blood flow in the oxygenation circuit is stable, thereby solving the problem of a reduced amount of blood actually used for oxygenation testing and extending the corresponding test window time; the first blood storage container and the second blood storage container are connected in an on-off manner, and a deoxygenation and oxygenation cycle operation can be realized during the test, thereby saving blood volume.
[0007] According to one embodiment of the present application, the inlet of the driving pump is connected to the first blood storage container through the first pipeline, and the outlet of the driving pump is connected to the first end of the fifth pipeline; The deaerator is connected to the second end of the fifth pipeline through the sixth pipeline; The inlet of the first blood storage container is connected to the blood outlet of the deoxygenator through the second pipeline; The first heater is connected to the heat exchange channel of the deaerator; The deoxygenated gas source is connected to the gas inlet of the deoxygenator; The blood inlet of the oxygenator to be evaluated is connected to the second end of the fifth pipeline through the seventh pipeline, the blood outlet of the oxygenator to be evaluated is connected to the first end of the eighth pipeline through the third pipeline, and the oxygenator to be evaluated is connected to the first blood storage container through the third pipeline; The inlet of the second blood storage container is connected to the second end of the eighth pipeline, and the outlet of the second blood storage container is connected to the inlet of the first blood storage container through the fourth pipeline; The second heater is connected to the heat exchange channel of the oxygenator to be evaluated; The oxygen-filled gas source is connected to the gas inlet of the oxygenator to be evaluated; Among them, the sixth pipeline is provided with a first shut-off device, and the first shut-off device is used to control the on-off of the sixth pipeline; the seventh pipeline is provided with a second shut-off device, and the second shut-off device is used to control the on-off of the seventh pipeline; the second pipeline is provided with a third shut-off device, and the third shut-off device is used to control the on-off of the second pipeline; the eighth pipeline is provided with a fourth shut-off device, and the fourth shut-off device is used to control the on-off of the eighth pipeline; the third pipeline is provided with a fifth shut-off device, and the fifth shut-off device is used to control the on-off of the third pipeline; the fourth pipeline is provided with a sixth shut-off device, and the sixth shut-off device is used to control the on-off of the fourth pipeline.
[0008] According to one embodiment of the present application, the in vitro testing device for gas exchange performance of a membrane oxygenator has a deoxygenation mode. In the deoxygenation mode, the deoxygenation source is connected to the gas inlet of the deoxygenator, the first heater is turned on, the driving pump is turned on, the second shut-off device, the fourth shut-off device, the fifth shut-off device and the sixth shut-off device are turned off, and the first shut-off device and the third shut-off device are turned on.
[0009] According to one embodiment of the present application, the in vitro testing device for gas exchange performance of a membrane oxygenator has a blood circulation mode. In the blood circulation mode, the oxygen filling source is connected to the gas inlet of the oxygenator to be evaluated, the second heater is turned on, the driving pump is turned on, the first shut-off device, the third shut-off device, the fourth shut-off device and the sixth shut-off device are closed, and the second shut-off device and the fifth shut-off device are turned on.
[0010] According to one embodiment of the present application, the in vitro testing device for gas exchange performance of a membrane oxygenator has an oxygenation test mode. In the oxygenation test mode, the oxygen filling source is connected to the gas inlet of the oxygenator to be evaluated, the second heater is turned on, the driving pump is turned on, the first shut-off device, the third shut-off device, the fifth shut-off device and the sixth shut-off device are closed, and the second shut-off device and the fourth shut-off device are turned on.
[0011] According to one embodiment of the present application, the blood inlet of the oxygenator to be evaluated is provided with a first sampling port, and the blood outlet of the oxygenator to be evaluated is provided with a second sampling port, and the first sampling port and the second sampling port are used for performing gas-blood analysis in oxygenation test mode.
[0012] According to one embodiment of the present application, the in vitro test device for gas exchange performance of a membrane oxygenator has a blood transfer mode. In the blood transfer mode, the driving pump is turned off, the first shut-off device, the second shut-off device, the third shut-off device, the fourth shut-off device and the fifth shut-off device are turned off, and the sixth shut-off device is turned on.
[0013] According to one embodiment of the present application, a ternary gas mixing device is included, and the ternary gas mixing device is connected to the deoxygenated gas source, wherein the ternary gas mixing device is used to mix three gases: oxygen, carbon dioxide and nitrogen.
[0014] According to an embodiment of the present application, a first flow monitor and a second flow monitor are included, wherein the first flow monitor is disposed in the second pipeline, and the second flow monitor is disposed in the third pipeline.
[0015] According to one embodiment of the present application, there are multiple deoxygenators, and the multiple deoxygenators are connected in parallel to form a deoxygenation module. The blood inlet of the deoxygenation module is connected to the second end of the fifth pipeline through the sixth pipeline; the inlet of the first blood storage container is connected to the blood outlet of the deoxygenation module through the second pipeline; the first heater is connected to the heat exchange channel of the deoxygenation module; and the deoxygenation gas source is connected to the gas inlet of the deoxygenation module.
[0016] Additional aspects and advantages of the present application will be given in part in the description below, and in part will become apparent from the description below, or will be learned through the practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS
[0017] In order to more clearly illustrate the technical solutions in the present invention or the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.
[0018] Figure 1 Schematic diagram of the structure of an in vitro test device for gas exchange performance of a membrane oxygenator in a deoxygenation mode according to an embodiment of the present invention.
[0019] Figure 2 FIG. 1 is a schematic structural diagram of an in vitro test device for gas exchange performance of a membrane oxygenator in a blood circulation mode according to an embodiment of the present invention.
[0020] Figure 3 Schematic diagram of the structure of an in vitro test device for gas exchange performance of a membrane oxygenator in an oxygenation test mode according to an embodiment of the present invention.
[0021] Figure 4 It is a schematic structural diagram of an in vitro testing device for gas exchange performance of a membrane oxygenator in a blood transfer mode according to an embodiment of the present invention.
[0022] Figure 5 FIG. 1 is a schematic structural diagram of an in vitro testing device for gas exchange performance of a membrane oxygenator in one embodiment of the present invention.
[0023] Reference numerals: 31. First blood storage container; 32. Second blood storage container; 33. First heater; 34. Second heater; 35. Driving pump; 36. Deoxygenator; 37. Deoxygenation source; 38. Oxygenation source; 39. Oxygenator to be tested; 310. First shut-off device; 311. Second shut-off device; 312. Fourth pipeline; 313. Third shut-off device; 314. Fourth shut-off device; 315. First pipeline; 316. Second pipeline; 3161. First flow monitor; 317. Fifth shut-off device; 318. Sixth shut-off device; 351. Fifth pipeline; 352. Sixth pipeline; 359. Seventh pipeline; 39. Oxygenator to be evaluated; 391. Third pipeline; 3911. First blood sampling point; 3912. Second blood sampling point; 3913. Second flow monitor; 392. Eighth pipeline; 43. Deoxygenation module. DETAILED DESCRIPTION
[0024] The following is a further detailed description of the implementation of the present application in conjunction with the accompanying drawings and examples. The following examples are used to illustrate the present application but cannot be used to limit the scope of the present application.
[0025] In the description of the embodiments of the present application, it should be noted that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the accompanying drawings, which are only for the convenience of describing the embodiments of the present application and simplifying the description, and do not indicate or imply 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 embodiments of the present application. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.
[0026] In the description of the embodiments of the present application, it should be noted that, unless otherwise clearly specified and limited, the terms "connected" and "connection" should be understood in a broad sense, for example, it can be a fixed connection or a detachable connection, wherein the fixed connection can include an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms in the embodiments of the present application can be understood according to specific circumstances.
[0027] In the embodiments of the present application, unless otherwise clearly specified and limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, a first feature being "above", "above" or "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below", "below" or "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.
[0028] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" etc. means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the embodiments of the present application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described may be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples, without contradiction.
[0029] Combine the following Figure 1-Figure 5 The in vitro testing device for gas exchange performance of a membrane oxygenator of the present invention is described.
[0030] The in vitro test device for gas exchange performance of a membrane oxygenator according to an embodiment of the present application comprises a first blood storage container 31, a second blood storage container 32, a first heater 33, a second heater 34, a driving pump 35, a deoxygenator 36, a deoxygenation source 37, an oxygen filling source 38 and an oxygenator to be evaluated 39; the inlet of the driving pump 35 is connected to the first blood storage container 31, the outlet of the driving pump 35 can be connected to the deoxygenator 36 and the oxygenator to be evaluated 39, and the inlet of the first blood storage container 31 can be connected to the blood outlet of the deoxygenator 36; the first heater 33 is connected to the heat exchange channel of the deoxygenator 36; the deoxygenation source 37 is connected to the gas inlet of the deoxygenator 36; the blood outlet of the oxygenator to be evaluated 39 can be connected to the first blood storage container 31 and the second blood storage container 32, and the outlet of the second blood storage container 32 can be connected to the inlet of the first blood storage container 31; the second heater 34 is connected to the heat exchange channel of the oxygenator to be evaluated 39; the oxygen filling source 38 is connected to the gas inlet of the oxygenator to be evaluated 39.
[0031] The in vitro test device for gas exchange performance of a membrane oxygenator of the present application adopts a first blood storage container 31 and a second blood storage container 32 to collect deoxygenated blood and oxygenated blood, thereby solving the problem that deoxygenated and oxygenated blood are mixed due to the use of one blood storage container during the test, causing inconsistent blood conditions during the test, thereby improving the accuracy of the test; one of the first blood storage container 31 and the second blood storage container 32 is connected in an on-off manner in the oxygenation circuit to collect oxygenated blood, and can be connected after the blood flow in the oxygenation circuit is stable, thereby solving the problem of a reduced amount of blood actually used for oxygenation testing and extending the corresponding test window time; the first blood storage container 31 and the second blood storage container 32 are connected in an on-off manner, and a deoxygenation and oxygenation cycle operation can be realized during the test, thereby saving blood volume.
[0032] It is understood that the oxygenator to be evaluated is a medical device that can replace the gas transfer function of the lungs and is used to treat patients with respiratory failure. The oxygen-filled source provides oxygen to the oxygenator to be evaluated to simulate the oxygen supply in the human body. The deoxygenator is used to remove oxygen from the blood to achieve a specific blood oxygen saturation. The deoxygenated source provides oxygen, carbon dioxide and nitrogen to the deoxygenator to simulate the deoxygenation process in the human body.
[0033] It can be understood that by selectively connecting or disconnecting various components, a cyclic operation of deoxygenation and oxygenation is achieved. This design not only improves the flexibility of the test, but also extends the test window time, making the test process more efficient.
[0034] In one embodiment, the inlet of the driving pump 35 is connected to the first blood storage container 31 through the first pipeline 315, and the outlet of the driving pump 35 is connected to the first end of the fifth pipeline 351; the deoxygenator 36 is connected to the second end of the fifth pipeline 351 through the sixth pipeline 352; the inlet of the first blood storage container 31 is connected to the blood outlet of the deoxygenator 36 through the second pipeline 316; the first heater 33 is connected to the heat exchange channel of the deoxygenator 36; the deoxygenation source 37 is connected to the gas inlet of the deoxygenator 36; the blood inlet of the oxygenator 39 to be evaluated is connected to the second end of the fifth pipeline 351 through the seventh pipeline 359, the blood outlet of the oxygenator 39 to be evaluated is connected to the first end of the eighth pipeline 392 through the third pipeline 391, and the oxygenator 39 to be evaluated is connected to the first blood storage container 31 through the third pipeline 391; the inlet of the second blood storage container 32 is connected to the second end of the eighth pipeline 392, and the outlet of the second blood storage container 32 is connected to the first blood storage container through the fourth pipeline 312 31; the second heater 34 is connected to the heat exchange channel of the oxygenator 39 to be evaluated; the oxygen filling source 38 is connected to the gas inlet of the oxygenator 39 to be evaluated; wherein the sixth pipeline 352 is provided with a first shut-off device 310, and the first shut-off device 310 is used to control the on-off of the sixth pipeline 352; the seventh pipeline 359 is provided with a second shut-off device 311, and the second shut-off device 311 is used to control the on-off of the seventh pipeline 359; the second pipeline 316 is provided with a third shut-off device 313, and the third shut-off device 313 is used to control the on-off of the second pipeline 316; the eighth pipeline 392 is provided with a fourth shut-off device 314, and the fourth shut-off device 314 is used to control the on-off of the eighth pipeline 392; the third pipeline 391 is provided with a fifth shut-off device 317, and the fifth shut-off device 317 is used to control the on-off of the third pipeline 391; the fourth pipeline 312 is provided with a sixth shut-off device 318, and the sixth shut-off device 318 is used to control the on-off of the fourth pipeline 312.
[0035] It can be understood that a complete in vitro test circulation system is constructed by cleverly connecting the first pipeline 315, the fifth pipeline 351, the sixth pipeline 352, the seventh pipeline 359, the third pipeline 391, the eighth pipeline 392, the second pipeline 316 and the fourth pipeline 312. This system can simulate the blood flow and gas exchange process in the human body, so as to accurately evaluate the gas exchange performance of the oxygenator to be evaluated.
[0036] The first heater 33 and the second heater 34 are respectively connected to the heat exchange channels of the deoxygenator 36 and the oxygenator to be evaluated 39, thereby ensuring the temperature of the blood is stable during the test.
[0037] In one embodiment, the first shut-off device 310 , the second shut-off device 311 , the third shut-off device 313 , the fourth shut-off device 314 , the fifth shut-off device 317 , and the sixth shut-off device 318 are hemostatic clips that can intercept blood in the tube.
[0038] Of course, one or more of the first shut-off device 310, the second shut-off device 311, the third shut-off device 313, the fourth shut-off device 314, the fifth shut-off device 317 and the sixth shut-off device 318 can adopt other on-off structures, such as valve body switches and other devices. By opening or closing the shut-off devices, the blood flow path and test conditions can be adjusted.
[0039] According to one embodiment of the present application, the in vitro testing device for gas exchange performance of a membrane oxygenator has a deoxygenation mode. In the deoxygenation mode, the deoxygenation source 37 is connected to the gas inlet of the deoxygenator 36, the first heater 33 is turned on, the drive pump 35 is turned on, the second shut-off device 311, the fourth shut-off device 314, the fifth shut-off device 317 and the sixth shut-off device 318 are turned off, and the first shut-off device 310 and the third shut-off device 313 are turned on.
[0040] The deoxygenation mode is mainly used to simulate the function of the human lungs during exhalation, removing oxygen from the blood through the deoxygenator to achieve a specific blood oxygen saturation. By precisely controlling the parameters of the deoxygenation process (such as the flow rate and temperature of the deoxygenated gas), different physiological conditions can be simulated, thereby more comprehensively evaluating the performance of the oxygenator.
[0041] It can be understood that, in the deoxygenation mode, the deoxygenation source 37 and the first heater 33 are turned on, and the first heater 33 can be set to (40±1)°C to keep the blood at a constant (37±1)°C.
[0042] In the deoxygenation mode, the blood flow path is as follows: blood is drawn from the first blood storage container 31 by the driving pump 35. It enters the driving pump 35 through the first pipeline 315 and is then transported to the fifth pipeline 351. The blood in the fifth pipeline 351 enters the deoxygenator 36 for deoxygenation. The deoxygenated blood flows back to the first blood storage container 31 through the second pipeline 316 (when the third shut-off device 313 is turned on).
[0043] According to one embodiment of the present application, the in vitro test device for gas exchange performance of a membrane oxygenator has a blood circulation mode. In the blood circulation mode, the oxygen filling source 38 is connected to the gas inlet of the oxygenator 39 to be evaluated, the second heater 34 is turned on, the drive pump 35 is turned on, the first shut-off device 310, the third shut-off device 313, the fourth shut-off device 314 and the sixth shut-off device 318 are closed, and the second shut-off device 311 and the fifth shut-off device 317 are turned on.
[0044] The blood circulation mode is mainly used to simulate the blood circulation process in the human body. The blood is oxygenated through the oxygenator to be evaluated to evaluate its gas exchange performance.
[0045] It can be understood that in the blood circulation mode, the second heater 34 of the oxygenator 39 to be evaluated is in a connected state, and the second heater 34 is set to (40±1)°C, so that the blood can be kept at a constant (37±1)°C.
[0046] In the blood circulation mode, the blood flow path is as follows: blood is drawn from the first blood storage container 31 by the driving pump 35. The blood enters the driving pump 35 through the first pipeline 315 and is then transported to the fifth pipeline 351. The blood in the fifth pipeline 351 enters the oxygenator 39 to be evaluated through the seventh pipeline 359 (when the second shutoff device 311 is opened) for oxygenation. The oxygenated blood flows back to the first blood storage container 31 through the third pipeline 391 and the fifth shutoff device 317 (when the fifth shutoff device 317 is opened).
[0047] In the blood circulation mode, the blood flow and oxygen-filled source gas flow of the blood circulation mode loop are first adjusted to reach the test conditions and run stably. After the oxygen-filled source gas flow is adjusted to be stable, it is not connected to the oxygenator 39 to be tested.
[0048] According to one embodiment of the present application, the in vitro testing device for gas exchange performance of a membrane oxygenator has an oxygenation test mode. In the oxygenation test mode, the oxygen supply 38 is connected to the gas inlet of the oxygenator 39 to be evaluated, the second heater 34 is turned on, the drive pump 35 is turned on, the first shut-off device 310, the third shut-off device 313, the fifth shut-off device 317 and the sixth shut-off device 318 are closed, and the second shut-off device 311 and the fourth shut-off device 314 are turned on.
[0049] The main purpose of the oxygenation test mode is to evaluate the ability of the oxygenator to oxygenate the blood under given conditions. By precisely controlling the parameters of the oxygenation process (such as the flow rate, temperature, pressure, etc. of the oxygenating gas), different physiological conditions can be simulated, thereby more comprehensively evaluating the performance of the oxygenator.
[0050] It can be understood that in the oxygenation test mode, the second heater 34 of the oxygenator 39 to be evaluated is in a connected state, and the second heater 34 is set to (40±1)°C, so that the blood can be kept at a constant (37±1)°C.
[0051] In oxygenation test mode, the blood flow path is as follows: Blood is drawn from the first blood storage container 31 by the driving pump 35. The blood enters the driving pump 35 through the first pipeline 315 and is then transported to the fifth pipeline 351. The blood in the fifth pipeline 351 enters the oxygenator 39 to be evaluated through the seventh pipeline 359 (when the second shutoff device 311 is opened) for oxygenation. The oxygenated blood flows into the second blood storage container 32 through the third pipeline 391 and the fourth shutoff device 314 (when the fourth shutoff device 314 is opened).
[0052] According to one embodiment of the present application, the blood inlet of the oxygenator 39 to be evaluated is provided with a first sampling port 3911, and the blood outlet of the oxygenator 39 to be evaluated is provided with a second sampling port 3912. The first sampling port 3911 and the second sampling port 3912 are used for performing gas-blood analysis in the oxygenation test mode.
[0053] Through the first sampling port 3911 and the second sampling port 3912, blood samples at the inlet and outlet can be obtained during the operation of the oxygenator, and then these samples can be analyzed for gas and blood, which helps to understand the oxygenation efficiency of the oxygenator, the carbon dioxide removal capacity, and other related parameter changes of the blood during the oxygenation process.
[0054] During the test, blood samples at the inlet and outlet can be obtained through the first sampling port 3911 and the second sampling port 3912. These samples are then sent to the laboratory for gas and blood analysis to calculate the oxygen and carbon dioxide conversion rates of the membrane oxygenator to be evaluated, wherein the oxygen and carbon dioxide conversion rates of the membrane oxygenator to be evaluated are calculated according to the following two formulas: P 1 =Hb×10×1.34×(△SO 2 )+3.14×10 -5 ×1000×(△PO 2 ); Where: P 1 is the oxygen conversion rate, in mL / L; Hb is the concentration of hemoglobin in whole blood, in g / dL; SO 2 is blood oxygen saturation, unit is % PO 2 is the oxygen partial pressure, in mmHg; △SO 2 The difference between the oxygen saturation in arterial blood and venous blood; △PO 2 is the difference in oxygen partial pressure between arterial blood and venous blood; 1.34 is the capacity constant of hemoglobin to bind oxygen, the unit is mLO 2 (Standard condition) / gHb; 3.14×10 -5 is the solubility coefficient of oxygen in blood, the unit is mLO 2 (standard condition) / mL / mmHg; P 2 =22.4×△ctCO 2 ; Where: P 2 is the carbon dioxide conversion rate, in mL / L; △ctCO 2 It is the difference between the total concentration of carbon dioxide in venous blood and arterial blood, expressed in mmol / L; 22.4 is the molar volume constant of carbon dioxide.
[0055] According to one embodiment of the present application, the in vitro test device for gas exchange performance of a membrane oxygenator has a blood transfer mode. In the blood transfer mode, the drive pump 35 is turned off, the first shut-off device 310, the second shut-off device 311, the third shut-off device 313, the fourth shut-off device 314 and the fifth shut-off device 317 are turned off, and the sixth shut-off device 318 is turned on.
[0056] Before the blood in the first blood storage container 31 is exhausted, the driving pump 35 is stopped, and only the sixth shut-off device 318 on the fourth pipeline 312 is opened, and all other shut-off devices in the loop are closed, so that the oxygenated blood in the second blood storage container 32 flows into the first blood storage container 31 by gravity, so as to repeat the deoxygenation mode, blood circulation mode, and oxygenation test mode.
[0057] According to one embodiment of the present application, the in vitro test device for gas exchange performance of a membrane oxygenator includes a ternary gas mixing device, which is connected to a deoxygenated gas source 37, wherein the ternary gas mixing device is used to mix three gases: oxygen, carbon dioxide and nitrogen.
[0058] The gas ternary mixing device is a device that can accurately control and mix oxygen, carbon dioxide and nitrogen. The gas exchange performance in vitro test device of the membrane oxygenator simulates the gas exchange environment in the human body.
[0059] According to one embodiment of the present application, the in vitro testing device for gas exchange performance of a membrane oxygenator includes a first flow monitor 3161 and a second flow monitor 3913 . The first flow monitor 3161 is disposed on the second pipeline 316 , and the second flow monitor 3913 is disposed on the third pipeline 391 .
[0060] It can be understood that the first flow monitor 3161 is disposed on the second pipeline 316, and the first flow monitor 3161 is responsible for monitoring the flow of the fluid in the second pipeline.
[0061] The second flow monitor 3913 is disposed on the third pipeline 391. The second flow monitor 3913 is responsible for monitoring the flow of the fluid in the third pipeline.
[0062] Flow detectors provide system operators with real-time flow data, enabling them to monitor the operating status of the system.
[0063] According to one embodiment of the present application, the in vitro test device for gas exchange performance of a membrane oxygenator includes a control host, which is used to control the start and stop of a driving pump 35, a first heater 33, and a second heater 34; And / or, the control host is used to control the on and off of the first shutoff device 310, the second shutoff device 311, the third shutoff device 313, the fourth shutoff device 314, the fifth shutoff device 317 and the sixth shutoff device 318; And / or, the control host is used to connect the first flow monitor 3161 and the second flow monitor 3913.
[0064] The control host is responsible for receiving user instructions, processing data and sending control signals to achieve precise control of each component in the system. In this embodiment, the control host can control the start and stop of the drive pump. The control host can control the start and stop of the two heaters to adjust the temperature of the fluid in the system. In biological testing or medical equipment, temperature is an important parameter that affects the physical and chemical properties of the fluid, thereby affecting the test results or the performance of the equipment.
[0065] The control host can control the on and off of the first shutoff device 310, the second shutoff device 311, the third shutoff device 313, the fourth shutoff device 314, the fifth shutoff device 317 and the sixth shutoff device 318 as needed to switch the deoxygenation mode, the circulation mode, the oxygenation test mode and the blood transfer mode, thereby realizing precise control of the fluid flow path. This is of great significance for testing the performance of oxygenators under different conditions, simulating different physiological environments, etc.
[0066] The control host can connect these two flow monitors to obtain real-time flow data of the fluid in the system. Through the control host, users can view the flow data at any time and make adjustments as needed.
[0067] According to one embodiment of the present application, the in vitro test device for gas exchange performance of a membrane oxygenator includes a display screen, which is connected to a control host, and the display screen is used to display working data of a driving pump 35, a first heater 33, and a second heater 34; And / or, the display screen is used to display the on / off data of the first shutoff device 310, the second shutoff device 311, the third shutoff device 313, the fourth shutoff device 314, the fifth shutoff device 317 and the sixth shutoff device 318; And / or, the display screen is used to display the flow data of the first flow monitor 3161 and the second flow monitor 3913.
[0068] The display screen is an important interface for users to interact with the test device. It is responsible for displaying various data and information from the control host, allowing users to intuitively understand the working status and test results of the test device.
[0069] The display screen can display the working data of the drive pump, such as speed, flow rate, etc. These data reflect the working status of the drive pump in the system.
[0070] The display screen can display the working data of the first heater 33 and the second heater 34, such as heating temperature, heating power, etc.
[0071] The display screen can display the on / off data of the first shutoff device 310 , the second shutoff device 311 , the third shutoff device 313 , the fourth shutoff device 314 , the fifth shutoff device 317 and the sixth shutoff device 318 , that is, whether they are in an on or off state.
[0072] The display screen can display the flow data of the first flow monitor 3161 and the second flow monitor 3913 in real time, including volume flow, flow velocity, etc.
[0073] In one embodiment, there are multiple deoxygenators 36, which are connected in parallel to form a deoxygenation module 43. The blood inlet of the deoxygenation module 43 is connected to the second end of the fifth pipeline 351 through the sixth pipeline 352; the inlet of the first blood storage container 31 is connected to the blood outlet of the deoxygenation module 43 through the second pipeline 316; the first heater 33 is connected to the heat exchange channel of the deoxygenation module 43; and the deoxygenation gas source 37 is connected to the gas inlet of the deoxygenation module 43.
[0074] It can be understood that the present embodiment uses multiple deoxygenators to perform deoxygenation work simultaneously, so that it can provide more blood that meets the test conditions in a timely manner for the oxygenation test, solves the complex operation of cyclic deoxygenation and oxygenation during the test process, and improves the test efficiency and accuracy.
[0075] The deoxygenation module is formed by connecting multiple deoxygenators in parallel, and the deoxygenation capacity of the deoxygenation module can be flexibly adjusted, which is suitable for gas exchange performance testing of various oxygenators.
[0076] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit it. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.
Claims
1. An in vitro test device for gas exchange performance of a membrane oxygenator, characterized in that: It comprises a first blood storage container (31), a second blood storage container (32), a first heater (33), a second heater (34), a driving pump (35), a deoxygenator (36), a deoxygenated gas source (37), an oxygenated gas source (38), and an oxygenator to be evaluated (39); The inlet of the driving pump (35) is connected to the first blood storage container (31); the outlet of the driving pump (35) can be connected to the deoxygenator (36) and the oxygenator (39) to be evaluated; the inlet of the first blood storage container (31) can be connected to the blood outlet of the deoxygenator (36); the first heater (33) is connected to the heat exchange channel of the deoxygenator (36); the deoxygenation source (37) is connected to the gas inlet of the deoxygenator (36); the blood outlet of the oxygenator (39) to be evaluated can be connected to the first blood storage container (31) and the second blood storage container (32); the outlet of the second blood storage container (32) can be connected to the inlet of the first blood storage container (31); the second heater (34) is connected to the heat exchange channel of the oxygenator (39) to be evaluated; and the oxygen filling source (38) is connected to the gas inlet of the oxygenator (39) to be evaluated.
2. The in vitro test device for gas exchange performance of a membrane oxygenator according to claim 1, characterized in that: The inlet of the driving pump (35) is connected to the first blood storage container (31) via the first pipeline (315), and the outlet of the driving pump (35) is connected to the first end of the fifth pipeline (351); The deoxidizer (36) is connected to the second end of the fifth pipeline (351) via the sixth pipeline (352); The inlet of the first blood storage container (31) is connected to the blood outlet of the deoxygenator (36) via the second pipeline (316); The first heater (33) is connected to a heat exchange channel of the deoxidizer (36); The deoxygenated gas source (37) is connected to the gas inlet of the deoxygenator (36); The blood inlet of the oxygenator (39) to be evaluated is connected to the second end of the fifth pipeline (351) through the seventh pipeline (359), the blood outlet of the oxygenator (39) to be evaluated is connected to the first end of the eighth pipeline (392) through the third pipeline (391), and the oxygenator (39) to be evaluated is connected to the first blood storage container (31) through the third pipeline (391); The inlet of the second blood storage container (32) is connected to the second end of the eighth pipeline (392), and the outlet of the second blood storage container (32) is connected to the inlet of the first blood storage container (31) via the fourth pipeline (312); The second heater (34) is connected to a heat exchange channel of the oxygenator (39) to be evaluated; The oxygen supply (38) is connected to the gas inlet of the oxygenator (39) to be evaluated; The sixth pipeline (352) is provided with a first shut-off device (310), and the first shut-off device (310) is used to control the on-off of the sixth pipeline (352); the seventh pipeline (359) is provided with a second shut-off device (311), and the second shut-off device (311) is used to control the on-off of the seventh pipeline (359); the second pipeline (316) is provided with a third shut-off device (313), and the third shut-off device (313) is used to control the on-off of the second pipeline (316). The eighth pipeline (392) is provided with a fourth shut-off device (314), and the fourth shut-off device (314) is used to control the on-off of the eighth pipeline (392); the third pipeline (391) is provided with a fifth shut-off device (317), and the fifth shut-off device (317) is used to control the on-off of the third pipeline (391); the fourth pipeline (312) is provided with a sixth shut-off device (318), and the sixth shut-off device (318) is used to control the on-off of the fourth pipeline (312).
3. The in vitro test device for gas exchange performance of membrane oxygenator according to claim 2, characterized in that: The in vitro test device for gas exchange performance of a membrane oxygenator has a deoxygenation mode. In the deoxygenation mode, the deoxygenation source (37) is connected to the gas inlet of the deoxygenator (36), the first heater (33) is turned on, the drive pump (35) is turned on, the second shut-off device (311), the fourth shut-off device (314), the fifth shut-off device (317) and the sixth shut-off device (318) are turned off, and the first shut-off device (310) and the third shut-off device (313) are turned on.
4. The in vitro test device for gas exchange performance of a membrane oxygenator according to claim 2, characterized in that: The in vitro test device for gas exchange performance of a membrane oxygenator has a blood circulation mode. In the blood circulation mode, the oxygen supply (38) is connected to the gas inlet of the oxygenator (39) to be evaluated, the second heater (34) is turned on, the drive pump (35) is turned on, the first shutoff device (310), the third shutoff device (313), the fourth shutoff device (314) and the sixth shutoff device (318) are turned off, and the second shutoff device (311) and the fifth shutoff device (317) are turned on.
5. The in vitro testing device for gas exchange performance of a membrane oxygenator according to claim 2, characterized in that: The in vitro test device for gas exchange performance of a membrane oxygenator has an oxygenation test mode. In the oxygenation test mode, the oxygen supply (38) is connected to the gas inlet of the oxygenator (39) to be evaluated, the second heater (34) is turned on, the drive pump (35) is turned on, the first shutoff device (310), the third shutoff device (313), the fifth shutoff device (317) and the sixth shutoff device (318) are turned off, and the second shutoff device (311) and the fourth shutoff device (314) are turned on.
6. The in vitro test device for gas exchange performance of a membrane oxygenator according to claim 5, characterized in that: The blood inlet of the oxygenator (39) to be evaluated is provided with a first sampling port, and the blood outlet of the oxygenator (39) to be evaluated is provided with a second sampling port, and the first sampling port and the second sampling port are used for performing gas-blood analysis in an oxygenation test mode.
7. The in vitro test device for gas exchange performance of a membrane oxygenator according to claim 2, characterized in that: The membrane oxygenator gas exchange performance in vitro testing device has a blood transfer mode. In the blood transfer mode, the driving pump (35) is turned off, the first shut-off device (310), the second shut-off device (311), the third shut-off device (313), the fourth shut-off device (314) and the fifth shut-off device (317) are turned off, and the sixth shut-off device (318) is turned on.
8. The in vitro testing device for gas exchange performance of a membrane oxygenator according to any one of claims 1 to 7, characterized in that: It comprises a gas ternary mixing device, the gas ternary mixing device is connected to the deoxygenated gas source (37), wherein the gas ternary mixing device is used to mix three gases: oxygen, carbon dioxide and nitrogen.
9. The in vitro testing device for gas exchange performance of a membrane oxygenator according to any one of claims 1 to 7, characterized in that: It comprises a first flow monitor (3161) and a second flow monitor (3913), wherein the first flow monitor (3161) is arranged on the second pipeline (316), and the second flow monitor (3913) is arranged on the third pipeline (391).
10. The in vitro testing device for gas exchange performance of a membrane oxygenator according to any one of claims 1 to 7, characterized in that: The number of the deoxygenators (36) is plural, and the plural deoxygenators (36) are connected in parallel to form a deoxygenation module (43); the blood inlet of the deoxygenation module (43) is connected to the second end of the fifth pipeline (351) via the sixth pipeline (352); the inlet of the first blood storage container (31) is connected to the blood outlet of the deoxygenation module (43) via the second pipeline (316); the first heater (33) is connected to the heat exchange channel of the deoxygenation module (43); and the deoxygenation gas source (37) is connected to the gas inlet of the deoxygenation module (43).