Bubble separation device for organ low-temperature mechanical perfusion and use method thereof

Abstract

The invention discloses a bubble separation device for organ low-temperature mechanical perfusion, and the device comprises a housing which is composed of a bottom housing and a cover body, the interior of the housing is a sealed cavity, the cover body is provided with a gas escape port, and the gas escape port is provided with a first water-blocking breathable film; the liquid inlet pipe is arranged on the shell; and the liquid discharge pipe is arranged on the shell. The invention further discloses a use method of the bubble separation device for organ low-temperature mechanical perfusion. Bubbles in the perfusion loop are discharged out of the pipeline at the first time by utilizing buoyancy of the bubbles and pressure in the perfusion pipeline, so that the risk of bubble separation failure caused by accumulation of a large number of bubbles is greatly reduced, and the bubble embolism risk of organ perfusion is reduced; the problems that a bubble separation function fails due to accumulation of a large number of bubbles, perfusion equipment repeatedly enters a flushing mode, and the most precious repair time of organs is wasted are avoided.

Description

TECHNICAL FIELD

[0001] The present application relates to a bubble separation device, in particular to a bubble separation device for organ hypothermic mechanical perfusion and a method of using the same. BACKGROUND

[0002] Hypothermic mechanical perfusion is a medical device that simulates the human blood circulation, mainly to play the function of organ preservation, transportation and repair before organ transplantation, so as to reduce the delayed functional recovery and other complications after transplantation. In the process of hypothermic mechanical perfusion, the gas bubbles in the perfusion liquid circuit will enter the organ artery with the perfusion liquid, which may cause embolism, so the separation and filtration of gas bubbles are the key link in the hypothermic mechanical perfusion technology.

[0003] In the existing hypothermic mechanical perfusion technology, a closed container is usually used as a bubble trapping device, and the gas bubbles in the liquid circuit are lifted to the upper part of the closed container by the buoyancy of the gas bubbles, and then the liquid in the container is pumped out through the outlet pipe below the container by the pressure generated by the pressure source in the liquid circuit, so as to realize gas-liquid separation. The existing technology has the following problems: the separation effect of the existing bubble separation device is not ideal, especially in the case of handling a large amount of gas bubbles, which may cause the liquid level in the closed container to drop sharply, and when the liquid level drops to the inlet of the low liquid level pipe, the gas bubbles will be punched into the low liquid level pipe, thereby losing the function of bubble separation.

[0004] The device disclosed in US8128740B2 uses a sealed sterile cavity to store gas bubbles in the upper part of the sealed container by the buoyancy of the gas bubbles, and the liquid is pumped out from the pipe below the container by the pressure of the perfusion circuit, and then enters the organ. This method will lose the function of gas-liquid separation in the presence of a large amount of gas bubbles, and when the volume of gas in the sealed container is large enough, the liquid level in the container will drop below the outlet of the low liquid level pipe, so that the gas bubbles reflow into the perfusion circuit and enter the organ. In order to solve this problem, the technical solution has to use a fixed time period to perform a bypass exhaust process once, which makes the pipe design very complex, and frequent bubble flushing will waste valuable organ perfusion time and slow down the organ repair process. SUMMARY

[0005] The purpose of the present application is to provide a bubble separation device for organ hypothermic mechanical perfusion, which aims to reduce the risk of gas embolism during organ perfusion.

[0006] In order to achieve the above purpose, the present application adopts the following technical scheme: a bubble separation device for organ hypothermic mechanical perfusion, characterized in that it has:

[0007] A shell composed of a bottom shell and a cover, the shell having a closed cavity inside, the cover being provided with a gas escape port, the first water-blocking and air-permeable film being arranged at the gas escape port;

[0008] A liquid inlet pipe arranged on the shell;

[0009] A liquid outlet pipe arranged on the shell.

[0010] Further, one side of the bottom shell is an opening, the opening is provided with a mounting step, and the cover is arranged at the mounting step.

[0011] Further, the cover comprises a cover body, a plurality of gas escape ports are arranged circumferentially on the cover body, and a liquid outlet pipe is arranged at the middle part of the cover body.

[0012] Further, the liquid inlet pipe is arranged on the bottom shell close to the cover.

[0013] Further, the inlet of the liquid outlet pipe extends to the inside of the cavity close to the bottom.

[0014] Further, the first water-blocking and air-permeable film is installed below the gas escape port of the cover, and the second water-blocking and air-permeable film is arranged on the side of the cover away from the cavity.

[0015] Further, the cover and the bottom shell are connected by a sealing ring, or the cover and the bottom shell are ultrasonically welded, or the cover and the bottom shell are bonded by an adhesive.

[0016] In another aspect, a method for using a bubble separation device for organ hypothermic mechanical perfusion, characterized in that the method uses the bubble separation device for organ hypothermic mechanical perfusion as claimed in any one of the above, comprising the following steps:

[0017] S1, under the initial condition of perfusion, under the action of external pump pressure, the gas-liquid mixture enters the device cavity from the liquid inlet pipe, and the liquid starts to cover the inlet (12-1) of the liquid outlet pipe under the pump pressure. At this time, since the fluid leakage pressure threshold of the exhaust hole of the first water-blocking and air-permeable film (3) is lower than that of the inlet (12-1) of the liquid outlet pipe, the air inside the cavity is pumped out through the exhaust hole of the first water-blocking and air-permeable film (3), the gas escape port (21) and the exhaust hole of the second water-blocking and air-permeable film (4);

[0018] When the second water-blocking and air-permeable film (4) is provided, the air inside the cavity is pumped out through the exhaust hole of the first water-blocking and air-permeable film (3), the gas escape port (21) and the exhaust hole of the second water-blocking and air-permeable film (4);

[0019] S2, when the liquid level rises to reach the first water-blocking breathable membrane (3), the exhaust hole fluid leakage pressure threshold of the first water-blocking breathable membrane (3) is much higher than the inlet (12-1) of the liquid discharge pipe under the action of the first water-blocking breathable membrane (3), liquid cannot be discharged from the exhaust hole of the first water-blocking breathable membrane (3), and under the action of pump pressure, liquid flows out from the inlet (12-1) of the liquid discharge pipe and the outlet (12-2) of the liquid discharge pipe;

[0020] During perfusion, when bubbles appear continuously in the liquid circuit, according to the above process, the liquid is separated from the gas through the gas-liquid separation device.

[0021] Compared with the prior art, the present application has the following beneficial effects: the present application uses a container with a water-blocking breathable membrane on the top to replace the original design of a sealed container, and uses the buoyancy of the bubbles and the pressure in the perfusion pipeline to first remove the bubbles in the perfusion circuit from the pipeline, thereby greatly reducing the risk of bubble separation failure caused by the accumulation of a large number of bubbles, thereby reducing the risk of bubble embolism in organ perfusion. Through the improvement of the water-blocking breathable membrane structure and the pipeline structure, the captured bubbles in the liquid circuit during mechanical perfusion are completely discharged in time, thereby avoiding the waste of the most precious repair time of the organ due to the accumulation of a large number of bubbles leading to bubble separation failure and the repeated entry of the perfusion equipment into the flushing mode. BRIEF DESCRIPTION OF DRAWINGS

[0022] Fig. 1 It is a perspective view of a bubble separation device for organ low-temperature mechanical perfusion.

[0023] Fig. 2 It is a cross-sectional view of a bubble separation device for organ low-temperature mechanical perfusion.

[0024] Fig. 3 It is an exploded view of a bubble separation device for organ low-temperature mechanical perfusion.

[0025] BRIEF DESCRIPTION OF DRAWINGS:

[0026] 1: housing, 1-1: bottom shell, 1-1a: mounting step, 11: liquid inlet pipe, 12: liquid discharge pipe, 12-1: inlet of liquid discharge pipe, 12-2: outlet of liquid discharge pipe, 2: cover, 21: gas escape port, 3: first water-blocking breathable membrane, 4: second water-blocking breathable membrane, 5: sealing ring. DETAILED DESCRIPTION

[0027] Example 1

[0028] Reference Figs. 1 to 3A bubble separation device for organ hypothermic mechanical perfusion has a shell 1 which is composed of a bottom shell 1-1 and a cover 2, and a closed cavity in the shell 1, and the cover 2 is provided with a gas escape port 21, and a first water-proof air-permeable film 3 is arranged at the gas escape port 21. In the embodiment, the first water-proof air-permeable film 3 is installed below the gas escape port 21 (the installation mode is only an example, and the specific position can be changed as long as the function is met). 2 @7kpa. It should be noted that the above values are only examples and are not limited, and in actual use, they can be changed as needed.

[0029] The liquid inlet pipe 11 is arranged on the shell 1. The liquid outlet pipe 12 is arranged on the shell 1.

[0030] In order to facilitate the installation of the cover and the stability after installation, one side (top) of the bottom shell 1-1 is open, and the open part is provided with a mounting step 1-1a, and the cover 2 is arranged at the mounting step 1-1a. The cover 2 and the bottom shell 1-1 are connected by a sealing ring 5; or the cover 2 and the bottom shell 1-1 can be ultrasonically welded; or the cover 2 and the bottom shell 1-1 are bonded by an adhesive, which includes but is not limited to UV glue, and reference can be made to the prior art. It should be noted that the above connection mode of the cover and the bottom shell is only an example and is not limited, and reference can be made to the prior art. After the cover and the bottom shell are connected, the shell is a closed cavity.

[0031] In the embodiment, the cover 2 includes a cover body, a plurality of gas escape ports 21 are arranged circumferentially on the cover body, and a liquid outlet pipe 12 is arranged in the middle of the cover body. The liquid inlet pipe 11 is arranged on the bottom shell 1-1 near the cover.

[0032] In the embodiment, the liquid outlet pipe 12 is L-shaped, and the inlet of the liquid outlet pipe extends to the cavity near the bottom. It should be noted that the shape of the liquid outlet pipe includes but is not limited to L-shaped, and reference can be made to the prior art as long as the function is met.

[0033] Fig. 3 In the embodiment, the arrow F1 is an example of the fluid flow path.

[0034] A method for using a bubble separation device for organ hypothermic mechanical perfusion, which uses the bubble separation device for organ hypothermic mechanical perfusion as described above, includes the following steps:

[0035] S1, under the initial condition of perfusion, under the external pump pressure, the gas-liquid mixture with a flow rate of 0-240 ml / min (preferably 240 ml / min) enters the device cavity from the liquid inlet pipe, and the liquid starts to overflow the inlet 12-1 of the liquid outlet pipe under the pump pressure, at this time, due to the low fluid leakage pressure threshold of the exhaust hole of the first water-blocking gas-permeable membrane 3 at the inlet 12-1 of the liquid outlet pipe, the air in the cavity is pumped out of the cavity through the exhaust hole of the first water-blocking gas-permeable membrane 3 and the gas escape port 21.

[0036] S2, when the liquid level rises to the water-blocking gas-permeable membrane, the fluid leakage pressure threshold of the exhaust hole of the water-blocking gas-permeable membrane is much higher than that at the inlet 12-1 of the liquid outlet pipe under the action of the water-blocking gas-permeable membrane, and the liquid cannot be discharged from the exhaust hole of the water-blocking gas-permeable membrane, and under the action of the pump pressure, the liquid flows out from the inlet 12-1 of the liquid outlet pipe and the outlet 12-2 of the liquid outlet pipe.

[0037] During perfusion, when bubbles appear continuously in the liquid circuit, according to the above process, the liquid is separated from the gas by the gas-liquid separation device.

[0038] Example 2

[0039] The scheme is the same as that of Example 1, except that in a gas bubble separation device for organ hypothermic mechanical perfusion, the first water-blocking gas-permeable membrane is installed below the gas escape port of the cover, and in order to prevent the liquid circuit in the cavity from being contaminated by the external environment during use or transportation, a second water-blocking gas-permeable membrane 4 is arranged on the side (outer side) of the cover 2 away from the cavity.

[0040] Correspondingly, in step S1 of the method for using the gas bubble separation device for organ hypothermic mechanical perfusion, "the air in the cavity is pumped out of the cavity through the exhaust hole of the first water-blocking gas-permeable membrane 3 and the gas escape port 21" is changed to "when the second water-blocking gas-permeable membrane 4 is arranged, the air in the cavity is pumped out of the cavity through the exhaust hole of the first water-blocking gas-permeable membrane 3, the gas escape port 21 and the exhaust hole of the second water-blocking gas-permeable membrane 4".

[0041] The above is only a preferred embodiment of the present application, and the protection scope of the present application is not limited to the above embodiment. Any technical solution that belongs to the principle of the present application is within the protection scope of the present application. For those skilled in the art, some improvements made without departing from the principle of the present application should also be considered as within the protection scope of the present application.

Claims

1. A bubble separation device for mechanical low temperature perfusion of organs, characterized in that, The application relates to a bubble separation device for organ low-temperature mechanical perfusion, which comprises the following components. A shell (1) is composed of a bottom shell (1-1) and a cover (2), the shell (1) is internally provided with a closed cavity, the cover (2) is provided with gas escape ports (21), and the first water-blocking and air-permeating film (3) is arranged at the gas escape ports (21); An inlet pipe (11) is arranged on the shell (1); An outlet pipe (12) is arranged on the shell (1).

2. A bubble separation device for mechanical low temperature perfusion of organs according to claim 1, characterized in that: One side of the bottom shell (1-1) is provided with an opening, the opening is provided with a mounting step (1-1a), and the cover (2) is arranged at the mounting step (1-1a).

3. The bubble separation device for mechanical low temperature perfusion of organs according to claim 1, characterized in that: The cover (2) comprises a cover main body, a plurality of gas escape ports (21) are arranged on the cover main body in a circumferential direction, and the outlet pipe (12) is arranged at the middle part of the cover main body.

4. The bubble separation device for mechanical low temperature perfusion of organs according to claim 1, characterized in that: The inlet pipe (11) is arranged on the bottom shell (1-1) close to the cover.

5. The bubble separation device for mechanical low temperature perfusion of organs according to claim 3, characterized in that: The inlet of the outlet pipe (12) extends to the cavity close to the bottom.

6. The bubble separation device for mechanical low temperature perfusion of organs according to claim 1, characterized in that: The first water-blocking and air-permeating film is arranged below the gas escape ports of the cover, the second water-blocking and air-permeating film (4) is arranged on the side of the cover (2) away from the cavity.

7. The bubble separation device for mechanical low temperature perfusion of organs according to claim 1, characterized in that: The cover (2) and the bottom shell (1-1) are connected through a sealing ring (5); Or the cover (2) and the bottom shell (1-1) are connected through ultrasonic welding; Or the cover (2) and the bottom shell (1-1) are connected through adhesive.

8. A method of using a bubble separation device for mechanical low temperature perfusion of organs, characterized in that, The method uses the bubble separation device for organ low-temperature mechanical perfusion according to any one of claims 1-7, and comprises the following steps: S1, under the initial perfusion condition, under the external pump pressure, the gas-liquid mixture enters the cavity of the device from the inlet pipe, and the liquid starts to cover the inlet (12-1) of the outlet pipe under the pump pressure, at this time, because the fluid leakage pressure threshold of the exhaust hole of the first water-blocking and air-permeating film (3) is lower than that of the inlet (12-1) of the outlet pipe, the air in the cavity is discharged out of the cavity through the exhaust hole of the first water-blocking and air-permeating film (3) and the gas escape port (21) under the pump pressure; When the second water-blocking and air-permeating film (4) is arranged, the air in the cavity is discharged out of the cavity through the exhaust hole of the first water-blocking and air-permeating film (3), the gas escape port (21) and the exhaust hole of the second water-blocking and air-permeating film (4) under the pump pressure; S2, when the liquid level rises to the first water-blocking and air-permeating film (3), the fluid leakage pressure threshold of the exhaust hole of the first water-blocking and air-permeating film (3) is much higher than that of the inlet (12-1) of the outlet pipe under the action of the first water-blocking and air-permeating film (3), the liquid cannot be discharged from the exhaust hole of the first water-blocking and air-permeating film (3), and the liquid flows out from the inlet (12-1) and the outlet (12-2) of the outlet pipe under the action of the pump pressure; During the perfusion process, when bubbles continuously appear in the liquid circuit, the liquid is separated from the gas through the gas-liquid separation device according to the above process.

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