CN116256292A - Membrane oxygenator plasma leakage testing device and testing method thereof - Google Patents

Membrane oxygenator plasma leakage testing device and testing method thereof Download PDF

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Publication number
CN116256292A
CN116256292A CN202111462160.4A CN202111462160A CN116256292A CN 116256292 A CN116256292 A CN 116256292A CN 202111462160 A CN202111462160 A CN 202111462160A CN 116256292 A CN116256292 A CN 116256292A
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China
Prior art keywords
membrane oxygenator
leakage
membrane
oxygenator
plasma
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CN202111462160.4A
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Chinese (zh)
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郭景军
倪澄峰
甘宇
邓智华
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Zhejiang Maitong Intelligent Manufacturing Technology Group Co ltd
Chuangmai Medical Technology Shanghai Co ltd
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Zhejiang Maitong Intelligent Manufacturing Technology Group Co ltd
Chuangmai Medical Technology Shanghai Co ltd
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Priority to CN202111462160.4A priority Critical patent/CN116256292A/en
Publication of CN116256292A publication Critical patent/CN116256292A/en
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N15/00—Investigating characteristics of particles; Investigating permeability, pore-volume, or surface-area of porous materials
    • G01N15/08—Investigating permeability, pore-volume, or surface area of porous materials
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02W—CLIMATE CHANGE MITIGATION TECHNOLOGIES RELATED TO WASTEWATER TREATMENT OR WASTE MANAGEMENT
    • Y02W10/00—Technologies for wastewater treatment
    • Y02W10/10—Biological treatment of water, waste water, or sewage

Abstract

The invention relates to the technical field of membrane oxygenator products, in particular to a membrane oxygenator plasma leakage testing device and a testing method thereof. The membrane type oxygenator plasma leakage testing device comprises a gas supply device, a fluid circulation device, a condensing device, a leakage collecting device and a weight measuring device, wherein the gas supply device is connected with a gas inlet of the membrane type oxygenator; the leakage collecting device is connected with the gas outlet of the membrane oxygenator through the condensing device, and the weight measuring device can measure the weight of leakage quantity of the leakage collecting device. The membrane oxygenator plasma leakage testing device is simple in component assembly and connection relation, and can be configured according to practical application scenes.

Description

Membrane oxygenator plasma leakage testing device and testing method thereof
Technical Field
The invention relates to the technical field of membrane oxygenator products, in particular to a membrane oxygenator plasma leakage testing device and a testing method thereof.
Background
The membrane oxygenator is a disposable artificial device capable of blood and gas exchange. According to the alveolar gas exchange principle, the device integrates functions of oxygenation, temperature change, blood storage, filtration and the like, and is used for replacing the lung function to perform blood oxygenation and discharge carbon dioxide so as to meet the needs of patients in operation.
The membrane oxygenator mostly adopts a mode that the inner cavity of a semipermeable membrane is used for gas and the outside is used for blood, and the principle is as follows: when a partial pressure gradient exists in any one of the gas components on both sides of the permeable membrane, the corresponding gas molecules will diffuse from the side with high partial pressure to the side with low partial pressure. By adjusting the partial pressure of the gas in the inner cavity of the semipermeable membrane, O is formed 2 Is greater than O in blood 2 And CO 2 Is less than the partial pressure of CO in blood 2 So that O of the inner cavity of the semipermeable membrane 2 Will pass through the semipermeable membrane and fuse with the blood outside the semipermeable membrane, and CO in the blood in the outer cavity of the semipermeable membrane 2 Will pass through the semi-permeable membrane to enter the gas, thereby realizing the oxygenation of human blood and CO 2 Regulate the excretion of O in blood 2 And CO 2 Is contained in the composition.
However, as previously mentioned, membrane oxygenators are a single-use, manual device whose semipermeable membranes lose the ability to prevent plasma leakage, which is an important form of failure of membrane oxygenators in practice, after a certain period of use. Therefore, how to perform and sometimes effectively judge the plasma leakage condition of the membrane oxygenator is a technical problem to be solved urgently.
Disclosure of Invention
Based on the problems in the prior art, the invention provides a membrane type oxygenator plasma leakage testing device and a testing method thereof, which can accurately test the time of failure caused by plasma leakage of an oxygenator assembly and provide effective reference for product design and quality evaluation.
The invention discloses a membrane oxygenator plasma leakage testing device, which comprises an air supply device, a fluid circulation device, a condensing device, a leakage collecting device and a weight measuring device, wherein,
the gas supply device is connected with a gas inlet of the membrane oxygenator;
the fluid circulation device is arranged outside the membrane oxygenator and connects the fluid inlet with the fluid outlet;
the condensing device is connected with the gas outlet of the membrane oxygenator, the leakage collecting device is used for receiving leakage liquid in the condensing device, and the weight measuring device can measure the weight of leakage quantity of the leakage collecting device.
In one embodiment, the fluid circulation device comprises a pumping drive and a reservoir assembly having a circulating fluid stored therein, the reservoir assembly being in communication with the fluid outlet of the membrane oxygenator, one end of the pumping drive being in communication with the reservoir assembly and the other end thereof being in communication with the fluid inlet of the membrane oxygenator.
In one embodiment, the fluid circulation device further comprises a thermostat device.
In one embodiment, the pumping drive is a hydraulic pump.
In one embodiment, the pumping drive is capable of constant pressure pumping.
In one embodiment, the condensing means comprises a condensing tube, the inlet of which communicates with the gas outlet of the membrane oxygenator, the outlet of which opens into the leakage collection means.
In one embodiment, the leak collection device is a beaker and the weight measurement device is an analytical balance.
The invention also discloses a membrane oxygenator plasma leakage test method, which uses any one of the membrane oxygenator plasma leakage test devices and comprises the following steps:
(1) Opening the air supply device, the fluid circulation device, the condensing device, the leakage collecting device and the weight measuring device, and starting timing when the weight measuring device has weight measuring record;
(2) Recording the weight data of the leakage liquid measured by the weight measuring device according to a preset interval, and calculating the leakage liquid increment in the preset interval;
(3) Comparing a plurality of leakage liquid increment at preset intervals, and summarizing the value ranges of the N leakage liquid increment before continuous operation;
(4) Finding out the first preset interval which does not accord with the value range of the leakage liquid increment, and obtaining the complete failure time of the membrane oxygenator.
In one embodiment, the membrane oxygenator plasma leakage test method further comprises setting the circulation temperature of the fluid circulation device to be 36-38 ℃, the circulation pressure to be 0.05-0.15 MPa, and the circulation flow rate to be 5-8L/min.
In one embodiment, the method for testing plasma leakage of a membrane oxygenator further comprises setting the pipeline pressure from the gas supply device to the membrane oxygenator to be 0.05MPa-0.1MPa, and the pipeline flow rate to be 5L/min-8L/min.
Advantageous effects
The membrane type oxygenator plasma leakage testing device has the advantages of simple component assembly and very simple connection relationship, and can rapidly complete the assembly of the membrane type oxygenator plasma leakage testing device. When the membrane oxygenator plasma leakage testing device is used for testing the membrane oxygenator, the membrane oxygenator can be configured according to the actual application scene of the membrane oxygenator, so that the testing result with high reference value for the actual application of the membrane oxygenator can be obtained.
The invention discloses a membrane oxygenator plasma leakage test method, which provides a test method for determining the complete leakage time of a membrane oxygenator for a person skilled in the art, and the principle of the method accords with objective characterization of complete failure of the membrane oxygenator, and the test method is simple and visual in test result. The test result obtained by the method has a strong practical application reference value, can help the person skilled in the art to further grasp the complete failure time of the membrane oxygenator, and provides reliable assistance for the person skilled in the art to carry out product design and quality evaluation.
Drawings
FIG. 1 is a schematic illustration of the membrane oxygenator plasma leakage testing device in some embodiments of the present invention;
FIG. 2 is a schematic view of the membrane oxygenator in some embodiments of the present invention;
FIG. 3 is a schematic illustration of the results of the membrane oxygenator plasma leakage test method in some embodiments of the present invention.
Wherein, 1 is the membrane oxygenator, 2 is the air feeder, 3 is the fluid circulation device, 5 is leakage collection device, 6 is the weighing device, 10 is the membrane shell, 11 is the gas inlet, 12 is the gas outlet, 13 is the fluid inlet, 14 is the fluid outlet, 15 is the membrane silk, 41 is the condenser pipe, 42 is the cold water machine.
Detailed Description
In order that the above objects, features and advantages of the invention will be readily understood, a more particular description of the invention will be rendered by reference to the appended drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. The present invention may be embodied in many other forms than described herein and similarly modified by those skilled in the art without departing from the spirit of the invention, whereby the invention is not limited to the specific embodiments disclosed below.
In the description of the present 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", "circumferential", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element being referred to must have a specific orientation, be configured and operated in a specific orientation, and therefore should not be construed as limiting the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include at least one such feature. In the description of the present invention, the meaning of "plurality" means at least two, for example, two, three, etc., unless specifically defined otherwise.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly, through intermediaries, or both, may be in communication with each other or in interaction with each other, unless expressly defined otherwise. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the present invention, unless expressly stated or limited otherwise, a first feature "up" or "down" a second feature may be the first and second features in direct contact, or the first and second features in indirect contact via an intervening medium. Moreover, a first feature being "above," "over" and "on" a second feature may be a first feature being directly above or obliquely above the second feature, or simply indicating that the first feature is level higher than the second feature. The first feature being "under", "below" and "beneath" the second feature may be the first feature being directly under or obliquely below the second feature, or simply indicating that the first feature is less level than the second feature.
It will be understood that when an element is referred to as being "fixed" or "disposed" on another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are used herein for illustrative purposes only and are not meant to be the only embodiment.
Referring to fig. 1, fig. 1 shows a membrane oxygenator plasma leakage testing device according to the present invention for testing a membrane oxygenator 1 according to fig. 2, wherein the membrane oxygenator 1 comprises a gas inlet 11, a gas outlet 12, a fluid inlet 13, and a fluid outlet 14, wherein the gas inlet 11 is in communication with the gas outlet 12, and the fluid inlet 13 is in communication with the fluid outlet 14. The membrane oxygenator plasma leakage testing device comprises an air supply device 2, a fluid circulation device 3, a condensing device, a leakage collecting device 5 and a weight measuring device 6, wherein the fluid circulation device 3 is arranged outside the membrane oxygenator 1, the fluid circulation device 3 is connected with a fluid inlet 13 and a fluid outlet 14, the air supply device 2 is connected with a gas inlet 11 of the membrane oxygenator 1, the condensing device is connected with a gas outlet 12 of the membrane oxygenator 1, the leakage collecting device is used for receiving leakage liquid in the condensing device, and the weight measuring device 6 can measure the weight of leakage quantity of the leakage collecting device 5.
It should be emphasized here that, since the membrane oxygenator 1 is composed of a very large number of membrane filaments, which are hollow, the interior of the membrane filament channels is used for the passage of gas, the exterior of the membrane filament channels is used for the passage of liquid, and the gas molecules can be exchanged by diffusion through the membrane filaments. However, after long-term use, the membrane filaments are gradually wetted by the blood plasma to lose the function of gas molecule dispersion, and finally, a large amount of blood plasma enters the inner pipeline of the membrane filaments through the channels for permeation gas molecule exchange, so that the membrane oxygenator is disabled.
According to the plasma leakage testing device of the membrane oxygenator, the practical application scene of the membrane oxygenator 1 is simulated by using the fluid circulation device 3 and the air supply device 2, so that the service life of the membrane oxygenator 1 in the practical application scene can be tested in a referential manner. Specifically, the membrane oxygenator plasma leakage testing device of the present invention starts the fluid circulation device 3 during testing, and is used for simulating the circulation liquid of plasma to enter the fluid inlet 13 of the membrane oxygenator 1 under the action of the circulation liquid and to be discharged from the fluid outlet 14, and then to enter the fluid inlet 13 again after passing through the fluid circulation device 3, so that the extracorporeal circulation of plasma in a practical application scene can be simulated. At the same time, the gas supply device 2 is started, the gas supply device 2 continuously inputs air flow to the gas inlet 11 of the membrane oxygenator 1, the air flow is discharged from the gas outlet 12 through the membrane wire inner pipeline, and part of gas molecules accompanied by the air flow enter the membrane wire inner pipeline through the gas molecule exchange channel. During long testing, the fluid circulation device 3 will cause the circulating fluid to continuously pass through the membrane oxygenator 1, resulting in the membrane filaments of the membrane oxygenator 1 being gradually wetted by the circulating fluid, gradually losing the ability to prevent the circulating fluid from penetrating the membrane filaments. This means that the circulating liquid slowly permeates the membrane filaments to produce fine droplets of circulating liquid and is discharged from the gas outlet 12 following the air flow. According to the membrane oxygenator plasma leakage testing device, the condensing device and the leakage collecting device 5 are arranged at the gas outlet 12, so that fine liquid drops in the air flow can be condensed and liquefied by the condensing device and collected by the leakage collecting device 5. Further, the liquid collected by the leakage collecting device 5 is subjected to weight measurement and recording by the weight measuring device 6, so that the change trend of the liquid leakage amount can be obtained.
It should be noted that, before the membrane oxygenator 1 fails, the air flow itself contains some water vapor, and the circulating liquid slowly permeates the membrane filaments to generate fine droplets, so that the weight of the collected liquid measured by the weight measuring device 6 should be slowly and uniformly increased. If the weight of the collecting liquid measured by the weight measuring device 6 changes by a significant amount after a certain moment in relation to the previous weight, this means that the circulating liquid has not slowly penetrated the membrane filaments of the membrane oxygenator, so that it can be judged that the membrane oxygenator has failed at that moment, i.e. that the longest service life of the membrane oxygenator with high reference value is obtained.
Specifically, the gas supply device 2 of the membrane oxygenator plasma leakage testing device of the present invention may be an external oxygen bottle, and the oxygen bottle is connected with the gas inlet 11 of the membrane oxygenator 1 through a pipeline. Preferably, the pipeline is further provided with a flowmeter, so that the oxygen flow of the oxygen bottle can be reasonably regulated to meet the requirements in the use scene.
Specifically, the membrane oxygenator plasma leakage testing device of the present invention, the fluid circulation device 3 comprises a pumping driving member and a container assembly, wherein the container assembly stores circulating liquid, the container assembly is communicated with the fluid outlet 14 of the membrane oxygenator 1, one end of the pumping driving member is communicated with the container assembly, and the other end of the pumping driving member is communicated with the fluid inlet 13 of the membrane oxygenator 1; the pumping drive draws the circulating liquid in the reservoir assembly and pumps the circulating liquid through the fluid inlet 13 into the membrane oxygenator 1. So set up, the pumping drive piece draws up and carries the circulation liquid from the container subassembly to the fluid inlet 13 of diaphragm type oxygenator, circulation liquid is from the fluid inlet 13 get into the diaphragm type oxygenator 1 and is discharged from the fluid outlet 14 again after the oxygenation, gets into the container subassembly, accomplishes the circulation of once circulation liquid.
Preferably, the fluid circulation device 3 further comprises a thermostat device, which can regulate the temperature of the circulating fluid and maintain the temperature at a fixed value. In some embodiments, to enhance the referenceability of the membrane oxygenator plasma leakage test device of the present invention, the circulating fluid temperature is preferably controlled at 37.+ -. 1 ℃ by the thermostat.
It will be appreciated that the membrane oxygenator plasma leak test device of the present invention is not limited to the pumping drive. In some embodiments, the pumping drive may be a hydraulic pump. Pipelines are arranged between the hydraulic pump and the container assembly, between the container assembly and the fluid outlet 14 of the membrane oxygenator 1 and between the hydraulic pump and the fluid inlet 13 of the membrane oxygenator 1, and the hydraulic pump pumps circulating liquid to be sent into the membrane oxygenator 1 through the pipelines.
In some embodiments, the pumping driving member is preferably capable of realizing constant pressure pumping, so that the membrane oxygenator 1 can be ensured to perform a test in a stable flow, so that the problem that the membrane oxygenator 1 is easy to be damaged irregularly under fluctuating pressure is avoided, and meanwhile, the pumping driving member is more close to the actual application scene of the membrane oxygenator, and service life test results with higher reference value can be provided.
It will be appreciated that the invention is not limited to the particular form of condensing unit. In some embodiments, the condensing device may be a cold trap. Still alternatively, in another embodiment, as shown in fig. 1, the condensing device includes a condensing tube 41 and a cold water machine 42, the cold water machine 42 can provide cooling water for the condensing tube 41 to realize cooling capability of the condensing tube 41, an inlet of the condensing tube 41 is connected to the gas outlet 12 of the membrane oxygenator 1, and an outlet of the condensing tube 41 leads to the leakage collecting device 5. The air flow input from the air supply device 2 carries tiny circulating liquid drops after passing through the membrane oxygenator 1, and the circulating liquid drops are cooled and converged into circulating liquid which can be metered after entering the condensing pipe 41, so that the circulating liquid can be collected by the leakage collecting device 5 and measured by the weight measuring device 6.
It will be readily appreciated that the present invention is not particularly limited to the specific embodiments of the leak collection apparatus 5 and the weight measurement apparatus 6. When the condensing means comprises a condensing tube 41, the leakage collecting device 5 may be a beaker arranged at the outlet of the condensing tube 41. Specifically, as shown in fig. 1, the condensation pipe 41 is vertically disposed, and the beaker is disposed right below the outlet of the condensation pipe 41, so that condensed circulating liquid droplets can automatically converge and fall into the beaker below under the action of gravity, thereby simplifying the leakage collection step. When the leak collection apparatus 5 is a beaker, the weight measuring apparatus 6 may be an analytical balance, and the beaker is directly placed on the analytical balance and the total weight of the leak collection apparatus 5 is continuously tested.
The invention also discloses a membrane oxygenator plasma leakage test method, which uses any one of the membrane oxygenator plasma leakage test devices and comprises the following steps:
(1) Opening the air supply device 2, the fluid circulation device 3, the condensation device, the leakage collection device 5 and the weight measurement device 6, and starting timing when the weight measurement device 6 has weight measurement record;
(2) Recording the weight data of the leakage liquid measured by the weight measuring device 6 according to a preset interval, and calculating the leakage liquid increment in the preset interval;
(3) Comparing a plurality of leakage liquid increment at preset intervals, and summarizing the value ranges of the N leakage liquid increment before the continuous operation;
(4) Finding out the first preset interval which does not accord with the value range of the leakage liquid increment, and obtaining the complete failure time of the membrane oxygenator.
The membrane oxygenator plasma leakage test method of the present invention specifically further comprises the step of preparing a circulating solution, namely adding lecithin into physiological saline with concentration of 0.9% according to the proportion of 1.5g/500ml for preparation.
The membrane oxygenator plasma leakage test method of the invention specifically comprises the steps of arranging the fluid circulation device 3, wherein the circulation temperature is 36-38 ℃, the circulation pressure is 0.05-0.15 MPa, and the circulation flow rate is 5-8L/min. Wherein preferably, in some embodiments, the circulation temperature of the fluid circulation device 3 is set to be 37 ℃, the circulation pressure is set to be 0.1MPa, and the circulation flow rate is set to be 6L/min. By the arrangement, the fluid circulation device 3 can simulate the application scene which is more in line with the membrane oxygenator in reality.
The plasma leakage test method of the membrane oxygenator, provided by the invention, particularly further comprises the step of setting the pipeline pressure from the gas supply device to the membrane oxygenator to be 0.05-0.1 MPa, and the pipeline flow rate to be 5-8L/min. Wherein preferably, in some embodiments, the pipeline pressure from the gas supply device 2 to the membrane oxygenator 1 is set to be 0.08MPa, and the pipeline flow rate is 6L/min. By the arrangement, the air supply device 2 can simulate the application scene which is more in line with the membrane oxygenator in reality.
FIG. 3 is a schematic diagram showing the results of the plasma leakage test method of the membrane oxygenator according to the present invention, wherein the ordinate represents the leakage increment in g, the abscissa represents time, and the ordinate represents h. In fig. 3, two curves A, B are shown, which correspond to two embodiments respectively, and as can be seen from fig. 3, the preset interval of the embodiment corresponding to the A, B curve is 1h.
Further analysis of FIG. 3 shows that the leakage increase for the embodiment corresponding to the A curve was consistently stabilized at 15.+ -. 1.5g for 1-10h, and 20.4g for 11h, and after 11h, the leakage increase for the embodiment corresponding to the A curve was increasing. Since the membrane filaments of the membrane oxygenator are a disposable material, the leakage through the membrane filaments must be increasing when they are completely wetted by the circulating fluid, and the a curve after 11h corresponds to this conclusion, it can be seen that the membrane oxygenator in the embodiment corresponding to the a curve has completely failed at 11 h.
Similarly, when analyzing fig. 3, the leakage increment in the embodiment corresponding to the B curve is always kept at 15±2g between 1h and 16h, but at 17h, the leakage increment in the embodiment corresponding to the B curve is increased to 20.5g sharply, the leakage increment trend of 1h to 16h before is no longer met, and after 17h, the leakage increment in the embodiment corresponding to the B curve is increased continuously, so that it can be seen that the membrane oxygenator of the embodiment corresponding to the B curve has completely failed at 17 h.
From the above analysis, it can be seen that by using the membrane oxygenator plasma leakage testing device and testing the membrane oxygenator according to the membrane oxygenator plasma leakage testing method of the present invention, the time for complete failure of the membrane oxygenator can be obtained in a relatively simple and intuitive manner.
It will be appreciated that although the preset interval is 1h in the foregoing embodiment, the person skilled in the art may still adjust the preset interval according to actual needs, for example, to 0.5h, so as to obtain a more accurate total failure time of the membrane oxygenator compared with the foregoing embodiment.
The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.
The above examples illustrate only a few embodiments of the invention, which are described in detail and are not to be construed as limiting the scope of the invention. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the invention, which are all within the scope of the invention. Accordingly, the scope of protection of the present invention is to be determined by the appended claims.

Claims (10)

1. A membrane oxygenator plasma leakage testing device is characterized by comprising an air supply device, a fluid circulation device, a condensing device, a leakage collecting device and a weight measuring device, wherein,
the gas supply device is connected with a gas inlet of the membrane oxygenator;
the fluid circulation device is arranged outside the membrane oxygenator and connects the fluid inlet with the fluid outlet;
the condensing device is connected with the gas outlet of the membrane oxygenator, the leakage collecting device is used for receiving leakage liquid in the condensing device, and the weight measuring device can measure the weight of the leakage liquid of the leakage collecting device.
2. The membrane oxygenator plasma leakage test device of claim 1 wherein the fluid circulation device comprises a pumping drive and a reservoir assembly, the reservoir assembly having circulation fluid stored therein, the reservoir assembly being in communication with the fluid outlet of the membrane oxygenator, one end of the pumping drive being in communication with the reservoir assembly and the other end being in communication with the fluid inlet of the membrane oxygenator.
3. A membrane oxygenator plasma leakage test device according to claim 1 or 2, wherein the fluid circulation device further comprises a thermostatic device.
4. The membrane oxygenator plasma leakage test device of claim 2, wherein the pumping drive is a hydraulic pump.
5. The membrane oxygenator plasma leakage test device according to claim 2, wherein said pumping drive is capable of constant pressure pumping.
6. The membrane oxygenator plasma leakage test device according to claim 1, wherein the condensing means comprises a condensing tube, an inlet of the condensing tube being in communication with a gas outlet of the membrane oxygenator, an outlet of the condensing tube leading to the leakage collection means.
7. The membrane oxygenator plasma leakage test device according to claim 1, wherein the leakage collection device is a beaker and the weighing device is an analytical balance.
8. A membrane oxygenator plasma leakage test method, characterized by using the membrane oxygenator plasma leakage test device according to any one of claims 1-7, and comprising the steps of:
(1) Opening the air supply device, the fluid circulation device, the condensing device, the leakage collecting device and the weight measuring device, and starting timing when the weight measuring device has weight measuring record;
(2) Recording the weight data of the leakage liquid measured by the weight measuring device according to a preset interval, and calculating the leakage liquid increment in the preset interval;
(3) Comparing a plurality of leakage liquid increment at preset intervals, and summarizing the value ranges of the N leakage liquid increment before continuous operation;
(4) Finding out the first preset interval which does not accord with the value range of the leakage liquid increment, and obtaining the complete failure time of the membrane oxygenator.
9. The method of claim 8, further comprising setting the circulation temperature of the fluid circulation device to be 36-38 ℃, the circulation pressure to be 0.05-0.15 MPa, and the circulation flow rate to be 5-8L/min.
10. The method of claim 8, further comprising providing the gas supply to the membrane oxygenator at a line pressure of 0.05MPa to 0.1MPa and a line flow rate of 5L/min to 8L/min.
CN202111462160.4A 2021-12-02 2021-12-02 Membrane oxygenator plasma leakage testing device and testing method thereof Pending CN116256292A (en)

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