CN217006884U - Plasma leakage testing device of membrane oxygenator - Google Patents
Plasma leakage testing device of membrane oxygenator Download PDFInfo
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- CN217006884U CN217006884U CN202123011680.1U CN202123011680U CN217006884U CN 217006884 U CN217006884 U CN 217006884U CN 202123011680 U CN202123011680 U CN 202123011680U CN 217006884 U CN217006884 U CN 217006884U
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Abstract
The utility model relates to the technical field of membrane oxygenator products, in particular to a plasma leakage testing device of a membrane oxygenator. The plasma leakage testing device of the membrane oxygenator comprises a gas supply device, a fluid circulating 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 circulating device is arranged outside the membrane oxygenator, and the fluid inlet is connected with a fluid outlet by the fluid circulating device; the leakage collecting device is connected with a gas outlet of the membrane oxygenator through a condensing device, and the weight measuring device can measure the weight of the leakage amount of the leakage collecting device. The plasma leakage testing device of the membrane oxygenator has simple components and concise connection relation, and can be configured according to practical application scenes.
Description
Technical Field
The utility model relates to the technical field of membrane oxygenator products, in particular to a plasma leakage testing device of a membrane oxygenator.
Background
A membrane oxygenator is a disposable manual device capable of blood-gas exchange. According to the principle of alveolar gas exchange, the device integrates functions of oxygenation, temperature change, blood storage, filtration and the like, is used for replacing the function of the lung to oxygenate blood and discharge carbon dioxide, and meets the requirements of patients in operation.
The existing membrane oxygenator mostly adopts a mode that a semi-permeable membrane inner cavity is used for air and blood is externally used, and the principle is as follows: when a partial pressure gradient exists between any one of the gas components on both sides of the permeable membrane, the corresponding gas molecules will diffuse from the side with the higher partial pressure to the side with the lower partial pressure. By adjusting the partial pressure of gas in the inner cavity of the semi-permeable membrane, O is generated2Has a gas partial pressure greater than O in blood2Partial pressure of gas of (2), and CO2Has a gas partial pressure less than that of CO in blood2Partial pressure of gas of (1), thus, O of the inner cavity of the semipermeable membrane2Will penetrate through the semi-permeable membrane to be fused with the blood outside the semi-permeable membrane, and CO in the blood outside the outer cavity of the semi-permeable membrane2Then the oxygen passes through the semi-permeable membrane and enters the gas, thereby realizing the oxygenation and CO of the human blood2Regulating O in blood2And CO2The content of (a).
However, as previously mentioned, membrane oxygenators are disposable artificial devices in which the semi-permeable membrane loses its ability to prevent plasma leakage, which is also a significant form of membrane oxygenator failure in practice, from gas exchange after a certain period of use. Therefore, how to timely and effectively judge the plasma leakage of the membrane oxygenator is a technical problem to be solved urgently at present.
SUMMERY OF THE UTILITY MODEL
Based on the problems in the prior art, the utility model provides a membrane oxygenator plasma leakage testing device which can accurately test the failure time of an oxygenator assembly caused by plasma leakage and provide effective reference for product design and quality evaluation.
The utility model discloses a plasma leakage testing device of a membrane oxygenator on one hand, which 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 oxygenator;
the fluid circulation device is arranged outside the membrane oxygenator and connects the fluid inlet with the fluid outlet;
the condensation device is connected with a gas outlet of the membrane oxygenator, the leakage collection device is used for receiving leakage liquid in the condensation device, and the weight measurement device can measure the weight of the leakage amount of the leakage collection device.
In one embodiment, the fluid circulation means comprises a pumping drive and a reservoir assembly, the reservoir assembly storing a circulating fluid therein, the reservoir assembly being in communication with the fluid outlet of the membrane oxygenator, the pumping drive having one end in communication with the reservoir assembly and another end in communication with the fluid inlet of the membrane oxygenator.
In one embodiment, the fluid circulation device further comprises a thermostat.
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 condenser tube, an inlet of the condenser tube communicates with the gas outlet of the membrane oxygenator, and an outlet of the condenser tube leads to the leakage collecting means.
In one embodiment, the leak collection device is a beaker and the weighing device is an analytical balance.
In one embodiment, the leak collection device is a beaker and the weighing device is an analytical balance.
In one embodiment, when the condensing means comprises a condenser tube, the beaker is placed directly below the outlet of the condenser tube, and the beaker is placed on an analytical balance.
In one embodiment, the gas supply device is connected with the membrane oxygenator through a pipeline, and a valve and a flow meter are arranged on the pipeline.
In one embodiment, the fluid circulation device is connected with the membrane oxygenator through a pipeline, and a valve and a flow meter are arranged on the pipeline.
Advantageous effects
The plasma leakage testing device of the membrane oxygenator has simple components and concise connection relation, and can quickly finish the assembly of the plasma leakage testing device of the membrane oxygenator. When the membrane oxygenator plasma leakage testing device is used for testing the membrane oxygenator, the membrane oxygenator can be configured according to the practical application scene of the membrane oxygenator, so that a testing result with high reference value for the practical application of the membrane oxygenator can be obtained.
The plasma leakage testing method for the membrane oxygenator disclosed by the utility model provides a testing method for determining the complete leakage time of the membrane oxygenator for a person skilled in the art, the principle of the testing method accords with the objective representation of complete failure of the membrane oxygenator, the testing method is simple, and the testing result is visual. The test result obtained by the method has a strong practical application reference value, can help the technicians in the field to further grasp the complete failure time of the membrane oxygenator, and provides reliable assistance for the technicians in the field to design products and evaluate quality.
Drawings
FIG. 1 is a schematic view of the membrane oxygenator plasma leak test 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 graph showing the test results of the membrane oxygenator plasma leak test method in some embodiments of the present invention.
Wherein, 1 is a membrane oxygenator, 2 is a gas supply device, 3 is a fluid circulation device, 5 is a leakage collection device, 6 is a weight measuring device, 10 is a membrane shell, 11 is a gas inlet, 12 is a gas outlet, 13 is a fluid inlet, 14 is a fluid outlet, 15 is a membrane wire, 41 is a condenser pipe, and 42 is a water cooler.
Detailed Description
In order to make the aforementioned objects, features and advantages of the present invention more comprehensible, embodiments accompanying figures are described in detail below. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.
In the description of the present invention, it is to be understood that the terms "central," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the utility model and to simplify the description, and are not intended to indicate or imply that the referenced device or element must have a particular orientation, be constructed and operated in a particular orientation, and are not to be considered limiting of the utility model.
Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the feature. In the description of the present invention, "a plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.
In the present invention, unless otherwise explicitly stated or limited, the terms "mounted," "connected," "fixed," and the like are to be construed broadly, e.g., as being permanently connected, detachably connected, or integral; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be interconnected within two elements or in a relationship where two elements interact with each other unless otherwise specifically limited. The specific meanings of the above terms in the present invention can be understood according to specific situations by those of ordinary skill in the art.
In the present invention, unless expressly stated or limited otherwise, the first feature "on" or "under" the second feature may be directly contacting the second feature or the first and second features may be indirectly contacting each other through intervening media. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature "under," "beneath," and "under" a second feature may be directly under or obliquely under the second feature, or may simply mean that the first feature is at a lesser elevation than the second feature.
It will be understood that when an element is referred to as being "secured to" 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 as used herein are for illustrative purposes only and do not denote a unique embodiment.
Referring to fig. 1, fig. 1 shows a membrane oxygenator plasma leakage testing device of the present invention for testing a membrane oxygenator 1 as described in fig. 2, the membrane oxygenator 1 includes a gas inlet 11, a gas outlet 12, a fluid inlet 13, and a fluid outlet 14, wherein the gas inlet 11 is communicated with the gas outlet 12, and the fluid inlet 13 is communicated with the fluid outlet 14. The membrane oxygenator plasma leakage testing device comprises a gas supply device 2, a fluid circulation device 3, a condensation device, a leakage collection device 5 and a weight measurement 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 gas supply device 2 is connected with a gas inlet 11 of the membrane oxygenator 1, the condensation device is connected with a gas outlet 12 of the membrane oxygenator 1, the leakage collection device is used for receiving leakage liquid in the condensation device, and the weight measurement device 6 can measure the weight of the leakage amount of the leakage collection device 5.
It is emphasized here that since the membrane oxygenator 1 is made up of a very large number of membrane filaments which are hollow, the inside of the membrane filament channels are used for the circulation of gas, and the outside of the membrane filament channels are used for the circulation of liquid, gas molecules can be exchanged by diffusion through the membrane filaments. However, after a long time of use, the membrane filaments are gradually wetted by the plasma and lose the function of dispersing gas molecules, and finally, a large amount of plasma enters the internal pipeline of the membrane filaments through the channel for permeating gas molecule exchange, so that the membrane oxygenator is out of work.
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 circulating 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 reference manner. Specifically, the membrane oxygenator plasma leakage testing device provided by the utility model starts the fluid circulation device 3 during testing, so that circulating liquid for simulating plasma is acted by the circulating liquid to enter the fluid inlet 13 of the membrane oxygenator 1 and is discharged from the fluid outlet 14, and enters the fluid inlet 13 again after passing through the fluid circulation device 3, thereby simulating the extracorporeal circulation of the plasma in a practical application scene. Meanwhile, the air supply device 2 is started, the air supply device 2 continuously inputs air flow to the air inlet 11 of the membrane oxygenator 1, the air flow is discharged from the air outlet 12 through the membrane filament internal pipeline, and part of gas molecules accompanying the air flow enter the membrane filament internal pipeline from the gas molecule exchange channel. In long-term testing, the fluid circulation device 3 causes 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 and gradually losing the ability to prevent the circulating fluid from penetrating the membrane filaments. This means that the circulating liquid will slowly penetrate the membrane filaments to produce fine circulating liquid droplets which follow the air flow and exit the gas outlet 12. The plasma leakage testing device of the membrane oxygenator has the advantages that the condensing device and the leakage collecting device 5 are arranged at the gas outlet 12, so that fine liquid drops in 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 measured and recorded by the weight measuring device 6, and the variation trend of the liquid leakage amount can be obtained.
It should be noted that before the membrane oxygenator 1 fails, the air flow contains some water vapor and the circulating liquid slowly permeates the membrane filaments to generate fine liquid drops, 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 collected liquid measured by the weight measuring device 6 changes by a significant increment from the previous weight after a certain time, this means that the circulating liquid has not slowly permeated the membrane filaments of the membrane oxygenator, so that it can be judged that the membrane oxygenator has failed at that time, that is, the longest service life of the membrane oxygenator with high reference value is obtained.
Specifically, the air supply device 2 of the plasma leakage testing device of the membrane oxygenator of the present invention may be an external oxygen cylinder, and the oxygen cylinder is connected to the air inlet 11 of the membrane oxygenator 1 through a pipeline. Preferably, a flow meter is further arranged on the pipeline, so that the oxygen flow of the oxygen bottle can be reasonably adjusted to meet the requirements in the use scene.
Specifically, the blood plasma leakage testing device of the membrane oxygenator of the present invention includes a pumping driving member and a container assembly, wherein the container assembly stores a circulating liquid therein, 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 pump drive draws the circulating fluid from the reservoir assembly and pumps it through the fluid inlet 13 into the membrane oxygenator 1. In this arrangement, the pumping drive pumps the circulating liquid from the container assembly and conveys the circulating liquid to the fluid inlet 13 of the membrane oxygenator, and the circulating liquid enters the membrane oxygenator 1 from the fluid inlet 13, is oxygenated, and then is discharged from the fluid outlet 14 again, enters the container assembly, and completes the circulation of the circulating liquid.
Preferably, the fluid circulation device 3 further includes a thermostat device capable of adjusting the temperature of the circulating liquid and maintaining the temperature at a constant value or so. In some embodiments, to enhance the referential of the membrane oxygenator plasma leakage testing device of the present invention, the temperature of the circulating fluid is preferably controlled at 37 ± 1 ℃ by the thermostatic device.
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 a fluid outlet 14 of the membrane oxygenator 1, and between the hydraulic pump and a fluid inlet 13 of the membrane oxygenator 1, and the hydraulic pump pumps up the circulating fluid and sends the circulating fluid into the membrane oxygenator 1 through the pipelines.
Preferably, in some embodiments, the pumping driving element can realize constant-pressure pumping, so that the membrane oxygenator 1 can be tested in a stable flow, the problem that the membrane oxygenator 1 is easily damaged abnormally under fluctuating pressure is avoided, the membrane oxygenator is closer to the actual application scene of the membrane oxygenator, and a service life test result with a higher reference value can be provided.
It will be understood that the utility model is not limited to the particular form of the 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 condensation pipe 41 and a water chiller 42, the water chiller 42 can provide cooling water to the condensation pipe 41 to realize the cooling capacity of the condensation pipe 41, an inlet of the condensation pipe 41 is connected to the gas outlet 12 of the membrane oxygenator 1, and an outlet of the condensation pipe 41 leads to the leakage collecting device 5. The air flow input from the air supply device 2 carries fine circulating liquid droplets after passing through the membrane oxygenator 1, and the circulating liquid droplets are cooled and converged into the circulating liquid which can be metered after entering the condensation pipe 41, so that the circulating liquid can be collected by the leakage collection device 5 and measured by the weight measuring device 6.
It will be readily appreciated that the present invention also has no particular requirement as to the specific embodiment of the leak collection means 5 and the weighing means 6. When the condensation device comprises a condensation duct 41, the leakage collection device 5 may be a beaker arranged at the outlet of the condensation duct 41. Specifically, as shown in fig. 1, the condensation pipe 41 is vertically arranged, and the beaker is arranged right below the outlet of the condensation pipe 41, so that the condensed circulating liquid drops can automatically converge under the action of gravity and fall into the beaker below, and the leakage collection step is simplified. When the leak collection device 5 is a beaker, the weighing device 6 can be an analytical balance, and the beaker is placed directly on the analytical balance and continuously tested for the total weight of the leak collection device 5.
The utility model also discloses a membrane oxygenator plasma leakage testing method, which uses any one of the membrane oxygenator plasma leakage testing devices and comprises the following steps:
(1) opening the gas supply device 2, the fluid circulation device 3, the condensing device, the leakage collecting device 5 and the weight measuring device 6, and starting timing when the weight measuring device 6 has weight measuring record;
(2) recording the weight data of the leakage liquid measured by the weight measuring device 6 according to preset intervals, and calculating the leakage liquid increment in the preset intervals;
(3) comparing the leakage liquid increments at a plurality of preset intervals, and summarizing the value ranges of the continuous former N leakage liquid increments;
(4) and finding out a first preset interval which does not accord with the value range of the leakage liquid increment to obtain the complete failure time of the membrane oxygenator.
The plasma leakage testing method of the membrane oxygenator, disclosed by the utility model, specifically comprises the step of preparing a circulating liquid, namely adding lecithin into physiological saline with the concentration of 0.9% according to the proportion of 1.5g/500 ml.
The plasma leakage testing method of the membrane oxygenator comprises the step of arranging the fluid circulating device 3, wherein the circulating temperature is 36-38 ℃, the circulating pressure is 0.05-0.15 MPa, and the circulating flow rate is 5-8L/min. Preferably, in some embodiments, the circulation temperature of the fluid circulation device 3 is set to 37 ℃, the circulation pressure is 0.1MPa, and the circulation flow rate is 6L/min. By such arrangement, the fluid circulation device 3 can simulate an application scene more suitable for the film oxygenator in reality.
The plasma leakage testing method of the membrane oxygenator specifically comprises the step of setting the pressure of a pipeline from the air supply device to the membrane oxygenator to be 0.05MPa-0.1MPa, and setting the flow rate of the pipeline to be 5L/min-8L/min. Preferably, in some embodiments, the pressure of the pipeline from the gas supply device 2 to the membrane oxygenator 1 is 0.08MPa, and the flow rate of the pipeline is 6L/min. So set up, gas supply unit 2 can simulate out the application scene that accords with membrane oxygenator in reality more.
FIG. 3 is a graph showing the results of the plasma leakage test using the membrane oxygenator of the present invention, with the ordinate representing the leakage increase in g and the abscissa representing time in h. In fig. 3, A, B curves are shown, which correspond to two embodiments, respectively, and it can be seen from fig. 3 that the preset interval of the embodiment corresponding to A, B curves is 1 h.
Further analysis of FIG. 3 reveals that the increase in leakage for the example corresponding to curve A is consistently stable at 15. + -. 1.5g between 1 and 10h, whereas the increase in leakage at 11h is 20.4g, and after 11h the increase in leakage for the example corresponding to curve A increases. Since the membrane filaments of the membrane oxygenator are a disposable material, the amount of leakage through the membrane filaments is necessarily increasing after being completely wetted by the circulating liquid, and the a-curve after 11h is consistent with 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, as shown in fig. 3, the amount of increase in leakage liquid in the embodiment corresponding to the B curve is kept at 15 ± 2g all the time between 1h and 16h, but at 17h, the amount of increase in leakage liquid in the embodiment corresponding to the B curve is increased sharply to 20.5g, which no longer conforms to the trend of the increase in leakage liquid between 1h and 16h before, and after 17h, the amount of increase in leakage liquid 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 of the present invention and testing the membrane oxygenator according to the membrane oxygenator plasma leakage testing method of the present invention, the total failure time of the membrane oxygenator can be obtained in a simpler and more intuitive manner.
It will be appreciated that although the preset interval is 1h in the foregoing embodiment, the preset interval may be adjusted by one skilled in the art according to actual needs, for example, the preset interval may be adjusted to 0.5h, etc., so as to obtain a more accurate occurrence time of the total failure of the membrane oxygenator than in the foregoing embodiment.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is more specific and detailed, but not construed as limiting the scope of the utility model. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (10)
1. A plasma leakage testing device of a membrane oxygenator 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 condensation device is connected with the gas outlet of the membrane oxygenator, the leakage collection device is used for receiving the leakage liquid in the condensation device, and the weight measuring device can measure the weight of the leakage liquid in the leakage collection device.
2. The membrane oxygenator plasma leak testing device of claim 1 wherein the fluid circulation device includes a pump drive and a reservoir assembly, the reservoir assembly having a circulating fluid stored therein, the reservoir assembly being in communication with the fluid outlet of the membrane oxygenator, the pump drive having one end in communication with the reservoir assembly and another end in communication with the fluid inlet of the membrane oxygenator.
3. A membrane oxygenator plasma leak testing device as claimed in claim 1 or 2 wherein the fluid circulation means further includes a thermostatic means.
4. A membrane oxygenator plasma leak testing device as claimed in claim 2 wherein the pumping drive is a hydraulic pump.
5. A membrane oxygenator plasma leak testing device as claimed in claim 2 wherein the pumping drive is capable of constant pressure pumping.
6. The membrane oxygenator plasma leak testing device of claim 1 wherein the condensing means includes a condenser tube, an inlet of the condenser tube communicating with a gas outlet of the membrane oxygenator, an outlet of the condenser tube leading to the leak collection means.
7. The membrane oxygenator plasma leak testing device of claim 1 wherein the leak collection device is a beaker and the weighing device is an analytical balance.
8. The membrane oxygenator plasma leak testing device of claim 7 wherein when the condensing device includes a condenser tube, the beaker is positioned directly below the outlet of the condenser tube, the beaker being positioned on an analytical balance.
9. A membrane oxygenator plasma leak testing device as claimed in claim 1 wherein the gas supply means is in line with the membrane oxygenator and wherein a valve and flow meter are provided in the line.
10. A membrane oxygenator plasma leak testing device as claimed in claim 1 wherein the fluid circulation means is in line with the membrane oxygenator and wherein a valve and flow meter are provided in the line.
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| CN202123011680.1U CN217006884U (en) | 2021-12-02 | 2021-12-02 | Plasma leakage testing device of membrane oxygenator |
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| CN202123011680.1U CN217006884U (en) | 2021-12-02 | 2021-12-02 | Plasma leakage testing device of membrane oxygenator |
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Address after: 200135 room 1015, building 1, No. 1601, Zhangdong Road, China (Shanghai) pilot Free Trade Zone, Pudong New Area, Shanghai Patentee after: Chuangmai Medical Technology (Shanghai) Co.,Ltd. Patentee after: Zhejiang Maitong Intelligent Manufacturing Technology (Group) Co.,Ltd. Address before: 200135 room 1015, building 1, No. 1601, Zhangdong Road, China (Shanghai) pilot Free Trade Zone, Pudong New Area, Shanghai Patentee before: Chuangmai Medical Technology (Shanghai) Co.,Ltd. Patentee before: MAITONG MEDICAL TECHNOLOGY (JIAXING) Co.,Ltd. |
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