CN221124228U - Device for detecting integrity of hollow fiber membrane of dialyzer - Google Patents
Device for detecting integrity of hollow fiber membrane of dialyzer Download PDFInfo
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- CN221124228U CN221124228U CN202322822721.8U CN202322822721U CN221124228U CN 221124228 U CN221124228 U CN 221124228U CN 202322822721 U CN202322822721 U CN 202322822721U CN 221124228 U CN221124228 U CN 221124228U
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Abstract
The utility model relates to the technical field of dialyzer detection, and discloses a device for detecting the integrity of a hollow fiber membrane of a dialyzer, which comprises a first pipeline, a second pipeline, a third pipeline, a fourth pipeline, a fifth pipeline and a sixth pipeline, wherein an upper blood chamber port of the dialyzer to be detected is communicated with a clean air source through the sixth pipeline and the first pipeline and is communicated with a process water source through the sixth pipeline and the third pipeline, an upper dialysate port of the dialyzer to be detected is communicated with the clean air source through the second pipeline, a lower blood chamber port of the dialyzer to be detected is communicated with a waste liquid tank through the fourth pipeline, and a lower dialysate port of the dialyzer to be detected is communicated with the waste liquid tank through the fifth pipeline. The detection device disclosed by the utility model can be applied to various processes including wet membrane, detection and air blowing and emptying of the hollow fiber membrane integrity detection of the dialyzer, and can be used for fully cleaning the inside and the outside of the hollow fiber membrane in the wet membrane process, so that the leachable content in the dialyzer is reduced, and the clinical application safety of the dialyzer is improved.
Description
Technical Field
The utility model relates to the technical field of dialyzer detection, in particular to a device for detecting the integrity of a hollow fiber membrane of a dialyzer.
Background
Hemodialysis filters (hereinafter, abbreviated as dialyzers) are a conventional hemodialysis apparatus mainly used for treating chronic renal failure, acute renal failure, drug poisoning and other diseases, and have been widely used clinically. The dialyzer consists of a membrane bundle, a shell, a sealing layer and an end cover, wherein the membrane bundle is a hollow fiber membrane and consists of a large number of hollow fibers, and a large number of membrane holes with specific size requirements are formed, if the hollow fiber walls are damaged, the loss of blood components of a patient can be caused, and the dialysis treatment effect of the patient is seriously affected, so that the integrity of the hollow fiber membrane needs to be detected in the production process of the dialyzer.
Meanwhile, the hollow fiber membrane is usually made of polysulfone or polyethersulfone, PVP, NMP or DAMC and the like are added in the spinning process, and in clinical use, harmful substances possibly remain, and the risk of entering blood is caused, so that the health of a human body is damaged, and therefore, the content of the substances in a dialyzer is required to be reduced as much as possible in clinical use.
The existing method for detecting the integrity of the hollow fiber membrane of the dialyzer comprises two methods of direct detection and indirect detection: indirect testing methods include turbidity detection, particle detection, etc., which are destructive detection, poor sensitivity, low resolution, and are often used as auxiliary detection means; direct detection methods include wet leak detection, air diffusion flow testing, vacuum decay testing, and the like. The method for detecting leakage by wet method can fill the dialyzer with process water, namely wet film, and can have a certain cleaning effect on the hollow fiber film of the dialyzer, so that the content of leachables such as PVP in the fiber film is reduced, and the method is more commonly used. However, the conventional wet detection device has unreasonable arrangement of a wet film pipeline, so that the cleaning effect is poor during wet film cleaning, and the hollow fiber film cannot be cleaned sufficiently.
Disclosure of utility model
The utility model discloses a device for detecting the integrity of a hollow fiber membrane of a dialyzer, which is used for solving the technical problem that the existing wet method device for detecting the integrity of the hollow fiber membrane of the dialyzer cannot sufficiently clean the hollow fiber membrane.
The utility model discloses a device for detecting the integrity of a hollow fiber membrane of a dialyzer, which comprises: a first pipeline, a second pipeline, a third pipeline, a fourth pipeline, a fifth pipeline and a sixth pipeline;
The first pipeline, the third pipeline and the sixth pipeline are connected through an electromagnetic three-way valve, an upper blood chamber port of the dialyzer to be tested is communicated with a clean air source through the sixth pipeline and the first pipeline, and the upper blood chamber port is communicated with a process water source through the sixth pipeline and the third pipeline;
The upper dialysate port of the dialyzer to be tested is communicated with the clean air source through the second pipeline, the lower blood chamber port of the dialyzer to be tested is communicated with the waste liquid tank through the fourth pipeline, and the lower dialysate port of the dialyzer to be tested is communicated with the waste liquid tank through the fifth pipeline;
The second pipeline is provided with a first electromagnetic valve, the fourth pipeline is provided with a second electromagnetic valve, and the fifth pipeline is provided with a third electromagnetic valve;
and a pressure sensor is arranged between the third electromagnetic valve and the lower dialysate port.
Optionally, the detection device further comprises a clamping module;
The clamping module is used for fixedly clamping the dialyzer to be tested.
Optionally, the clamping module comprises a base, a blood chamber port sealing connection unit and a dialysate port sealing connection unit;
The blood chamber port sealing connection unit is arranged on the base and comprises a first blood chamber port sealing connector and a second blood chamber port sealing connector;
The first blood chamber port sealing connector is used for sealing and connecting the lower blood chamber port and the fourth pipeline, and the second blood chamber port sealing connector is used for sealing and connecting the upper blood chamber port and the sixth pipeline;
The dialysate port sealing connection unit is arranged on the base and comprises a first dialysate port sealing connector and a second dialysate port sealing connector;
The first dialysate port sealing connector is used for being in sealing connection with the lower dialysate port and the fifth pipeline, and the second dialysate port sealing connector is used for being in sealing connection with the upper dialysate port and the second pipeline.
Optionally, the clamping module further comprises a first movable connection unit;
The first movable connecting unit is arranged on the base, one end of the first movable connecting unit is connected with the first dialysate opening sealing connector, and the other end of the first movable connecting unit is connected with the second dialysate opening sealing connector;
The first movable connecting unit is used for adjusting the positions of the first dialysate opening sealing connector and the second dialysate opening sealing connector.
Optionally, the clamping module further comprises a second movable connection unit;
The second movable connecting unit is arranged on the base, one end of the second movable connecting unit is connected with the first blood chamber opening sealing connector, and the other end of the second movable connecting unit is connected with the second blood chamber opening sealing connector;
The second movable connecting unit is used for adjusting the positions of the first blood chamber opening sealing connector and the second blood chamber opening sealing connector.
Optionally, the process water source is a process water generating device.
Optionally, the clean air source is a clean air generating device.
Optionally, an air pump is arranged between the first pipeline and the clean air source and between the second pipeline and the clean air source.
Optionally, a negative pressure pump is arranged between the fourth pipeline and the waste liquid tank and between the fifth pipeline and the waste liquid tank.
Optionally, the detection device further comprises a control module;
The control module is used for carrying out data monitoring and acquisition on the measurement data of the pressure sensor and controlling all pumps on the first electromagnetic valve, the second electromagnetic valve, the third electromagnetic valve, the electromagnetic three-way valve and the detection device pipeline.
From the above technical scheme, the utility model has the following advantages:
The utility model provides a device for detecting the integrity of a hollow fiber membrane of a dialyzer, which comprises a first pipeline, a second pipeline, a third pipeline, a fourth pipeline, a fifth pipeline and a sixth pipeline, wherein an upper blood chamber port of the dialyzer to be detected is communicated with a clean air source through the sixth pipeline and the first pipeline and is communicated with a process water source through the sixth pipeline and the third pipeline, an upper dialysate port of the dialyzer to be detected is communicated with the clean air source through the second pipeline, a lower blood chamber port of the dialyzer to be detected is communicated with a waste liquid tank through the fourth pipeline, and a lower dialysate port of the dialyzer to be detected is communicated with the waste liquid tank through the fifth pipeline. The detection device provided by the utility model can be applied to various processes of wet detection of the integrity of the hollow fiber membrane of the dialyzer including wet membrane detection and air blowing emptying, and can be used for fully cleaning the inside and the outside of the hollow fiber membrane in the wet membrane process, so that the leachable content in the dialyzer is reduced, and the clinical application safety of the dialyzer is improved.
Drawings
In order to more clearly illustrate the embodiments of the utility model or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, it being obvious that the drawings in the description below are only some embodiments of the utility model, and that other drawings can be obtained from these drawings without inventive faculty for a person skilled in the art.
Fig. 1 is a schematic structural diagram of a device for detecting the integrity of a hollow fiber membrane of a dialyzer according to an embodiment of the present utility model;
Fig. 2 is a schematic structural diagram of a clamping module of a detection device according to an embodiment of the present utility model;
FIG. 3 is a schematic diagram of wet membrane, detection and blow-down vent channels of a wet detection device for the integrity of hollow fiber membranes in a dialyzer of the prior art;
Fig. 4 is a schematic diagram of a wet film, detection and air-blowing evacuation channel of a detection device according to an embodiment of the present utility model.
Detailed Description
The embodiment of the utility model discloses a device for detecting the integrity of a hollow fiber membrane of a dialyzer, which solves the technical problem that the conventional wet detection device cannot sufficiently clean the hollow fiber membrane.
The following description of the embodiments of the present utility model will be made apparent and fully in view of the accompanying drawings, in which some, but not all embodiments of the utility model are shown. All other embodiments, which can be made by those skilled in the art based on the embodiments of the utility model without making any inventive effort, are intended to be within the scope of the utility model.
In the description of the present utility model, it should be noted that the directions or positional relationships indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, are merely for convenience of describing the present utility model and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present utility model. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance.
Unless specifically stated or limited otherwise, the terms "mounted," "connected," and "coupled" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present utility model will be understood in specific cases by those of ordinary skill in the art.
Referring to fig. 1, fig. 1 is a schematic structural diagram of a device for detecting the integrity of a hollow fiber membrane of a dialyzer according to an embodiment of the utility model.
The first embodiment of the utility model provides a device for detecting the integrity of a hollow fiber membrane of a dialyzer, which comprises: a first line 1, a second line 2, a third line 3, a fourth line 4, a fifth line 5 and a sixth line 6;
The first pipeline 1, the third pipeline 3 and the sixth pipeline 6 are connected through an electromagnetic three-way valve 7, the upper blood chamber port of the dialyzer to be tested is communicated with a clean air source through the sixth pipeline 6 and the first pipeline 1, and the upper blood chamber port is communicated with a process water source through the sixth pipeline 6 and the third pipeline 3;
The upper dialysate port of the dialyzer to be tested is communicated with a clean air source through a second pipeline 2, the lower blood chamber port of the dialyzer to be tested is communicated with a waste liquid tank through a fourth pipeline 4, and the lower dialysate port of the dialyzer to be tested is communicated with the waste liquid tank through a fifth pipeline 5;
The second pipeline 2 is provided with a first electromagnetic valve 8, the fourth pipeline 4 is provided with a second electromagnetic valve 9, and the fifth pipeline 5 is provided with a third electromagnetic valve 10;
A pressure sensor 11 is arranged between the third solenoid valve 10 and the lower dialysate port.
It is understood that the clean air source is a source of high quality, clean, pollution-free air which is provided after effective treatment, filtration or purification, and can be a clean air generating device; an air pump 18 can be arranged between the first pipeline 1 and the second pipeline 2 and the clean air source and used for conveying the clean air from the clean air source to the dialyzer to be tested; the process water source refers to a supply source of process water used in the integrity detection of the hollow fiber membrane of the dialyzer, and can be a process water generating device; a negative pressure pump 19 can be arranged between the fourth pipeline 4 and the fifth pipeline 5 and the waste liquid box and is used for providing negative pressure to suck the process water into the dialyzer to be tested; in addition to the first pipeline or the third pipeline being communicated with the sixth pipeline by adjusting the electromagnetic three-way valve, the passing pressure of the process water can be adjusted by adjusting the electromagnetic three-way valve 7.
By adjusting the opening and closing states of the first electromagnetic valve 8, the second electromagnetic valve 9, the third electromagnetic valve 10 and the electromagnetic three-way valve 7, the detection device provided by the embodiment can have various pipeline connection states, and different steps of the hollow fiber membrane integrity wet detection are correspondingly completed.
In practical use, when the integrity of the hollow fiber membrane of the dialyzer to be tested is detected, the method can comprise the following steps: 1. test preparation: connecting each port of the dialyzer to be tested with a corresponding pipeline on the detection device provided by the embodiment;
2. Wet film: detecting that the hollow fiber membrane of the dialyzer is wetted, so that the pores of the normal pore diameter of the fiber membrane are sealed by the surface tension of water; closing the channel connecting the electromagnetic three-way valve 7 with the first pipeline 1, opening the channel connecting the electromagnetic three-way valve 7 with the third pipeline 3 and the sixth pipeline 6, closing the first electromagnetic valve 8, opening the second electromagnetic valve 9 and the third electromagnetic valve 10, and forming two wet film channels in the detection device at the moment: 1) The water source for the process is 3-third pipeline, 6-upper blood chamber port, 6-lower blood chamber port, 4-fourth pipeline and waste liquid tank, 2) the water source for the process is 3-sixth pipeline, 6-upper blood chamber port, lower dialysate port and 5-waste liquid tank, and the process water flows in from the upper blood chamber port and the lower dialysate port of the dialyzer to be tested through the two wet film channels, flows out from the lower blood chamber port and the lower dialysate port respectively, so that the hollow fiber films are wetted;
3. And (3) detection: all channels of the electromagnetic three-way valve 7 are closed, the second electromagnetic valve 9 is closed, the first electromagnetic valve 8 and the third electromagnetic valve 10 are opened, and at this time, detection channels are formed in the detection device: clean gas source- (second pipeline 2- (upper dialysate port) - (lower dialysate port) - (fifth pipeline 5- (waste liquid tank), clean gas flowing in from upper dialysate port of dialyzer to be tested through detection channel, and discharging from lower dialysate port; after ventilation for a period of time, all valves on the detection device are closed, so that the pressure in the dialyzer to be detected is maintained for a period of time, and the pressure drop of the pressure sensor 11 in the pressure maintaining time is observed and recorded; if the pressure drop exceeds the allowable range, the hollow fiber membrane is damaged, wherein the surface tension of the water is insufficient to maintain the sealing, and the membrane of the dialyzer to be detected is broken and cannot be used; if the pressure is reduced within the allowable range, the hollow fiber membrane is complete, and the dialyzer to be tested does not break the membrane;
4. Blowing and emptying: excessive water cannot be contained in the finished product of the final dialyzer, otherwise, the quality of the dialyzer is affected, and therefore a water film for testing needs to be blown out and emptied; the channels connecting the electromagnetic three-way valve 7 with the first pipeline 1 and the sixth pipeline 6 are opened, the channels connecting the electromagnetic three-way valve 7 with the third pipeline 3 are closed, and two air blowing and emptying channels are formed in the detection device at the moment: 1) Clean air source 1- (sixth pipeline 1- (upper blood chamber port) - (lower blood chamber port) - (fourth pipeline 4- (waste liquid tank), 2) clean air source 1- (sixth pipeline 6- (upper blood chamber port) - (lower dialysate port) - (fifth pipeline 5- (waste liquid tank), clean air enters from upper blood chamber port of dialyzer to be tested through the above two blowing evacuation channels, and is discharged from lower blood chamber port and lower dialysate port respectively; and (3) after ventilation for a period of time, evacuating the redundant water adsorbed in the dialyzer to be detected, taking down the dialyzer for storage, and completing wet detection.
It should be noted that, the description of the above practical use method is merely for illustrating the beneficial effects that the structure of the device provided by the present utility model can bring in practical application, and does not represent that the content of the application protection of the device relates to the above method, and does not represent that the beneficial effects of the device depend on the method completely; after the device is obtained, a person skilled in the art can perform wet detection by himself, and the wet detection can be realized by combining a product structure and a known technology and is not in the innovative limit of the utility model; the passing pressure and passing time of the process water, the detecting ventilation time of clean gas, the blowing and emptying ventilation time, the pressure maintaining time and the pressure drop allowable range can be set according to the requirements of wet detection, different technical effects can be achieved under different settings, and a person skilled in the art can debug the process water after obtaining the structural scheme.
As comparison of technical effects, reference can be made by combining with the prior art, in the existing wet method detection device for the integrity of the hollow fiber membrane of the dialyzer, as no pipeline communicated between the dialysate port and the waste liquid tank under the dialyzer to be detected is arranged, when in the wet membrane step, process water can only enter the port of the lower blood chamber from the port of the upper blood chamber, liquid only flows in the hollow fiber membrane, and does not flow out of the hollow fiber membrane, and the upper, middle and lower parts of the figure 3 correspond to the channels of the existing wet method detection device in the wet membrane, detection and air blowing emptying steps respectively; in the detection device provided by the utility model, as the pipeline communicated between the lower dialysate opening and the waste liquid box is arranged, the process water flows out from the lower dialysate opening and the lower dialysate opening when wet, the process of flowing out of the hollow fiber membrane to the outside of the membrane is increased, and the pore diameters in the membrane and the pore diameters outside the membrane are continuously flushed in the wet membrane process of water injection wetting, so that the dialysis membrane can be cleaned more fully, the leachable substance content in the dialyzer is reduced, and the clinical application safety of the dialyzer is improved.
Further, the detection device provided by the utility model can further comprise a control module; the control module is used for carrying out data monitoring and acquisition on the measurement data of the pressure sensor and controlling all pumps on the first electromagnetic valve 8, the second electromagnetic valve 9, the third electromagnetic valve 10, the electromagnetic three-way valve 7 and the detection device pipeline. Based on common knowledge, a person skilled in the art can calculate the pressure data collected by the control module and send control feedback to each electromagnetic valve, so as to realize the automatic operation of the actual use method of the detection device, and how to control is not described in detail in this embodiment.
In a preferred embodiment, the detection device further comprises a clamping module 12, the clamping module 12 being adapted to fixedly clamp the dialyzer to be tested.
In a more preferred embodiment, referring to fig. 2, the clamping module 12 comprises a base 13, a blood port sealing connection unit 14 and a dialysate port sealing connection unit 15;
The blood chamber port sealing connection unit 14 is arranged on the base 13 and comprises a first blood chamber port sealing connector and a second blood chamber port sealing connector;
The first blood chamber port sealing connector is used for sealing and connecting the lower blood chamber port with the fourth pipeline, and the second blood chamber port sealing connector is used for sealing and connecting the upper blood chamber port with the sixth pipeline;
The dialysate port sealing connection unit 15 is arranged on the base 13 and comprises a first dialysate port sealing connector and a second dialysate port sealing connector;
the first dialysate mouth sealing connector is used for sealing connection of the lower dialysate mouth and the fifth pipeline, and the second dialysate mouth sealing connector is used for sealing connection of the upper dialysate mouth and the second pipeline.
It can be understood that the arrangement of the blood chamber port sealing connection unit 14 and the dialysate port sealing connection unit 15 can avoid air leakage at the connection part of the dialyzer to be tested and the pipeline during pressure maintaining, and influence the accuracy of the detection result.
Further, the clamping module 12 further comprises a first articulation unit 16;
The first movable connecting unit 16 is arranged on the base 13, one end of the first movable connecting unit is connected with the first dialysate opening sealing connector, and the other end of the first movable connecting unit is connected with the second dialysate opening sealing connector;
The first movable connection unit 16 is used for adjusting the positions of the first dialysate opening sealing joint and the second dialysate opening sealing joint.
Further, the clamping module further comprises a second movable connection unit 17;
the second movable connecting unit 17 is arranged on the base 13, one end of the second movable connecting unit is connected with the first blood chamber port sealing connector, and the other end of the second movable connecting unit is connected with the second blood chamber port sealing connector;
The second movable connection unit 17 is used for adjusting the positions of the first blood chamber opening sealing connector and the second blood chamber opening sealing connector.
It should be noted that, the positions of the first dialysate port sealing connector, the second dialysate port sealing connector, the first blood chamber port sealing connector and the second blood chamber port sealing connector are adjusted by the first movable connecting unit 16 and the second movable connecting unit 17, so that the dialyzer to be tested can be conveniently mounted on the clamping device.
The foregoing describes the device for detecting the integrity of a hollow fiber membrane in a dialyzer according to the present utility model in detail, and those skilled in the art will recognize that the utility model is not limited to the specific embodiments and application ranges given by the concepts of the embodiments of the present utility model.
Claims (10)
1. A device for detecting the integrity of a hollow fiber membrane in a dialyzer, comprising: a first pipeline, a second pipeline, a third pipeline, a fourth pipeline, a fifth pipeline and a sixth pipeline;
The first pipeline, the third pipeline and the sixth pipeline are connected through an electromagnetic three-way valve, an upper blood chamber port of the dialyzer to be tested is communicated with a clean air source through the sixth pipeline and the first pipeline, and the upper blood chamber port is communicated with a process water source through the sixth pipeline and the third pipeline;
The upper dialysate port of the dialyzer to be tested is communicated with the clean air source through the second pipeline, the lower blood chamber port of the dialyzer to be tested is communicated with the waste liquid tank through the fourth pipeline, and the lower dialysate port of the dialyzer to be tested is communicated with the waste liquid tank through the fifth pipeline;
The second pipeline is provided with a first electromagnetic valve, the fourth pipeline is provided with a second electromagnetic valve, and the fifth pipeline is provided with a third electromagnetic valve;
and a pressure sensor is arranged between the third electromagnetic valve and the lower dialysate port.
2. The detection device of claim 1, further comprising a clamping module;
The clamping module is used for fixedly clamping the dialyzer to be tested.
3. The testing device of claim 2, wherein the clamping module comprises a base, a blood port sealing connection unit, and a dialysate port sealing connection unit;
The blood chamber port sealing connection unit is arranged on the base and comprises a first blood chamber port sealing connector and a second blood chamber port sealing connector;
The first blood chamber port sealing connector is used for sealing and connecting the lower blood chamber port and the fourth pipeline, and the second blood chamber port sealing connector is used for sealing and connecting the upper blood chamber port and the sixth pipeline;
The dialysate port sealing connection unit is arranged on the base and comprises a first dialysate port sealing connector and a second dialysate port sealing connector;
The first dialysate port sealing connector is used for being in sealing connection with the lower dialysate port and the fifth pipeline, and the second dialysate port sealing connector is used for being in sealing connection with the upper dialysate port and the second pipeline.
4. A testing device according to claim 3, wherein the clamping module further comprises a first articulating unit;
The first movable connecting unit is arranged on the base, one end of the first movable connecting unit is connected with the first dialysate opening sealing connector, and the other end of the first movable connecting unit is connected with the second dialysate opening sealing connector;
The first movable connecting unit is used for adjusting the positions of the first dialysate opening sealing connector and the second dialysate opening sealing connector.
5. A testing device according to claim 3, wherein the clamping module further comprises a second articulating unit;
The second movable connecting unit is arranged on the base, one end of the second movable connecting unit is connected with the first blood chamber opening sealing connector, and the other end of the second movable connecting unit is connected with the second blood chamber opening sealing connector;
The second movable connecting unit is used for adjusting the positions of the first blood chamber opening sealing connector and the second blood chamber opening sealing connector.
6. The test device of claim 1, wherein the process water source is a process water generating device.
7. The test device of claim 1, wherein the clean air source is a clean air generating device.
8. The test device of claim 1, wherein an air pump is disposed between the first and second lines and the clean air source.
9. The apparatus according to claim 1, wherein a negative pressure pump is provided between the fourth and fifth pipes and the waste liquid tank.
10. The detection device of claim 1, further comprising a control module;
The control module is used for carrying out data monitoring and acquisition on the measurement data of the pressure sensor and controlling all pumps on the first electromagnetic valve, the second electromagnetic valve, the third electromagnetic valve, the electromagnetic three-way valve and the detection device pipeline.
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CN202322822721.8U CN221124228U (en) | 2023-10-20 | 2023-10-20 | Device for detecting integrity of hollow fiber membrane of dialyzer |
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CN202322822721.8U CN221124228U (en) | 2023-10-20 | 2023-10-20 | Device for detecting integrity of hollow fiber membrane of dialyzer |
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