A hemoperfusion cartridge

Abstract

The present application discloses a hemoperfusion device, which includes a cylinder body. A filter element assembly is arranged inside the cylinder body. A flexible blood bag is arranged at the top of the cylinder body. A flexible liquid bag is arranged inside the cylinder body and is internally connected to the filter element assembly. The volume of the flexible liquid bag can change under the action of an external force. A filter membrane assembly internally connected to the filter element assembly is arranged inside the flexible blood bag. An inlet and an outlet are arranged on the flexible blood bag. Two one-way valves arranged in the same direction are respectively arranged on both sides of the filter membrane assembly. A partition is arranged inside the blood bag. A reflux channel is formed between the partition and the filter membrane assembly, and the interior of the blood bag is divided into a first inner cavity and a second inner cavity. After the blood enters the first inner cavity through the inlet, it flows into the cylinder body from one one-way valve. After the blood is filtered by the filter membrane assembly and the filter element assembly, it flows to the second inner cavity from the other one-way valve. Part of the blood flows out through the outlet, and part of the blood can flow back to the first inner cavity through the reflux channel.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to a hemoperfusion cartridge. Background Art

[0002] Existing hemoperfusion cartridges are mainly unpacked filters filled with encapsulated activated carbon or neutral macroporous resin. Most of their technical improvements are in the encapsulation process, resin improvement, sealing, and filling structure. The prior art fails to solve problems such as the filter material in the filter element coming into direct contact with blood and being prone to blood clotting, and the encapsulated activated carbon or macroporous resin being worn due to mutual friction and extrusion during transportation. Moreover, since the filling amount of the filler is set at the factory, its performance is only divided according to the factory model and filling amount, and the performance cannot be continuously adjusted. Also due to technical limitations, the filler used has a relatively large size and general kinetic performance in mass transfer. And during use, manual participation is required to repeatedly pat and exhaust air, flush out particles, and observe the whole process, which requires high operation requirements. Summary of the Invention

[0003] In view of the above problems, this application discloses a hemoperfusion cartridge to overcome or at least partially solve the above problems.

[0004] The technical solution adopted in this application is as follows: A hemoperfusion cartridge includes a cylinder body, a filter element assembly is arranged inside the cylinder body, a flexible blood bag is arranged at the top of the cylinder body, a flexible liquid bag is arranged inside the cylinder body, the inside of the flexible liquid bag is communicated with the inside of the filter element assembly, the volume of the flexible liquid bag can change under the action of an external force, a filter membrane assembly is arranged inside the flexible blood bag, the inside of the filter membrane assembly is communicated with the inside of the filter element assembly, a liquid inlet and a liquid outlet are arranged on the flexible blood bag, two one-way valves are respectively arranged on both sides of the filter membrane assembly in the same direction, a partition is arranged inside the blood bag, one end of the partition is hermetically connected to the blood bag, a reflux channel is formed between the other end of the partition and the filter membrane assembly, the partition and the filter membrane assembly divide the inside of the blood bag into a first inner cavity and a second inner cavity, after blood enters the first inner cavity through the liquid inlet, it flows into the cylinder body through one one-way valve, after the blood is filtered by the filter membrane assembly and the filter element assembly, it flows to the second inner cavity through the other one-way valve, and part of the blood flows out through the liquid outlet, and part of the blood can flow back to the first inner cavity through the reflux channel.

[0005] Preferably, the filter membrane assembly is hermetically connected to the top cover of the cylinder body. The filter membrane assembly further includes membrane filaments and a housing. The two one-way valves are arranged on the housing. The membrane filaments are installed between the two one-way valves and on the top of the filter element assembly. The membrane filaments are used to separate plasma and blood cells in the blood.

[0006] Preferably, the partition is a heat-sealed line

[0007] Preferably, the interior of the cylinder body includes an upper partition chamber and a lower partition chamber. The filter element assembly is arranged in the upper partition chamber, and the flexible liquid bag is arranged in the lower partition chamber. A driving hole is formed in the lower partition chamber, and the driving hole is used to connect an air pump or an injection pump.

[0008] Preferably, the filter element assembly includes a filter element forming body and a filter membrane covering the periphery of the filter element forming body. A plasma channel is formed by hollowing out the interior of the filter element forming body, and the plasma channel is communicated with the flexible liquid bag.

[0009] Preferably, the filter element forming body is in the shape of a hollow cylinder, and the filter membrane is wrapped and covered on the outer wall of the hollow cylinder.

[0010] Preferably, a baffle is arranged between the upper partition chamber and the lower partition chamber. The baffle is hermetically connected to the outer wall of the cylinder body. A connecting pipe is arranged on the baffle, and the flexible liquid bag is hermetically connected to the lower end of the connecting pipe. The plasma channel is communicated with the flexible liquid bag through the connecting pipe.

[0011] Preferably, a sealing partition is arranged at the top of the filter element assembly for covering the filter element forming body and the plasma channel. There is a circulation gap between the sealing partition and the top cover of the upper partition chamber, and blood can flow to the filter membrane assembly through the circulation gap.

[0012] Preferably, the pore diameter of the membrane filaments is 0.04μm - 0.4μm, the thickness of the membrane filaments is 30μm - 300μm, the pore diameter of the filter membrane is 1μm - 10μm, and the thickness of the filter membrane is 60μm - 600μm.

[0013] Preferably, the filter element forming body contains at least one material such as activated carbon and adsorption resin with a particle size of 20μm - 200μm, and is formed by fiber bonding.

[0014] The advantages and beneficial effects of the present application are as follows: By expanding or compressing the effective volume of the flexible liquid bag, the effective volume of the lower partition chamber is changed. Taking this as the driving force, plasma is filtered out from the blood and enters the filter element forming body for plasma adsorption, and then this part of plasma is forced to enter the blood again; under the action of the reciprocating flow, the effective flux of the blood passing through the filter element forming body is changed, thereby improving its performance.

[0015] The flexible blood bag can buffer the pulsation of the blood under the action of the reciprocating flow, protect the patient's venous blood vessels, and can also reduce the mixing ratio, thereby improving the filtration efficiency under the action of the reciprocating flow.

[0016] During the operation of the device, the blood enters the filter element assembly through the filter membrane assembly, so that the blood cells do not directly contact the adsorbent in the filter element assembly, and the safety performance is better; when the effective volume of the flexible liquid bag does not change, very little blood enters the filter element assembly passively. Therefore, even if the perfusion device is not removed for a long time, it is very difficult to generate a desorption problem.

[0017] The particle size of the adsorbent that can be selected for the filter element forming body is much wider, and the powder adsorbent can also be used safely, thus broadening the selection range of the adsorbent. Compared with the existing loose-packed filter material adsorbent, the present invention effectively reduces the requirements for dust generation and coating, so the manufacturing cost is reduced; moreover, the liquid in the flexible liquid bag does not exchange with the fluid in the lower partition cavity, which has safety; in addition, choosing a fiber-bonded filter element as the filter element forming body instead of extruded or sintered activated carbon can significantly reduce the problem of plastic microparticles entering the blood.

[0018] During flushing, due to the structural characteristics, air bubbles and particles can be removed without manual patting and observation. Place the hemoperfusion cartridge upright, connect the liquid inlet to the flushing liquid, and connect the air pump or syringe pump after the driving hole is opened. Start the air pump or syringe pump, and the air pump or syringe pump reciprocates, causing the flexible filter bag to continuously compress and expand, forcing the flushing liquid to repeatedly enter and exit the filter element forming body. The flushing liquid is then discharged from the liquid outlet. During this process, due to the fact that the liquid descends and the gas ascends, the liquid enters the interior of the filter element forming body and then enters the flexible filter bag, while the gas is discharged from the filter element forming body. The syringe pump can automatically discharge the gas completely after several repetitions, without repeatedly patting to exhaust gas and flushing particles. After flushing, the hemoperfusion cartridge can be inverted. Similarly, at this time, the hemoperfusion cartridge can play the role of removing air bubbles in the pipeline. Brief Description of the Drawings

[0019] By reading the following detailed description of the preferred embodiments, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present invention. Moreover, throughout the drawings, the same reference numerals are used to represent the same components. In the drawings:

[0020] Figure 1 is a schematic structural diagram of the hemoperfusion cartridge of the present application;

[0021] Figures 2 - 3 is a schematic diagram of blood circulation during the actual application of the present application.

[0022] In the figure: S cylinder body; S1 top cover; F blood flow direction; 1 liquid inlet; 2 liquid outlet; 3 filter element assembly; 31 filter element forming body; 32 filter membrane; 33 plasma channel; 34 sealing partition; 4 upper partition cavity; 5 lower partition cavity; 51 flexible liquid bag; 6 baffle; 61 connecting pipe; 7 driving hole; 8 flow gap; 9 blood bag; 91 filter membrane assembly; 911 membrane filaments; 912 one-way valve; 913 outer shell; 92 separator; 93 return channel; 101 first inner cavity; 102 second inner cavity. Detailed Description of the Embodiments

[0023] To make the objectives, technical solutions, and advantages of the present invention clearer, the following will clearly and completely describe the technical solutions of the present invention in conjunction with specific embodiments of the present invention and the corresponding drawings. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all of the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts belong to the scope of protection of the present invention.

[0024] The following will, with reference to the accompanying drawings, elaborate on the technical solutions provided by each embodiment of the present application. Referring to Figure 1 , the hemoperfusion device of this embodiment includes a cylinder S. A filter element assembly 3 is arranged inside the cylinder S. A flexible blood bag 9 is arranged at the top of the cylinder S. A flexible liquid bag 51 is arranged inside the cylinder S. The inside of the flexible liquid bag 51 is communicated with the inside of the filter element assembly 3. The volume of the flexible liquid bag 51 can change under the action of an external force. A filter membrane assembly 91 is arranged inside the flexible blood bag 9. The inside of the filter membrane assembly 91 is communicated with the inside of the filter element assembly 3. An inlet 1 and an outlet 2 are arranged on the flexible blood bag 9. Two one-way valves 912 arranged in the same direction are respectively opened on both sides of the filter membrane assembly 91. A partition 92 is arranged inside the blood bag 9. One end of the partition 92 is hermetically connected to the blood bag 9. The other end of the partition 92 is close to the filter membrane assembly 91 and forms a reflux channel 93 with the filter membrane assembly 91. The partition 92 and the filter membrane assembly 91 divide the inside of the blood bag into a first inner cavity 101 and a second inner cavity 102. Referring to Figure 2 and Figure 3 for the blood flow direction F, after the blood enters the first inner cavity 101 through the inlet 1, it flows into the cylinder S through one one-way valve 912. After the blood is filtered by the filter membrane assembly 91 and the filter element assembly 3, it flows through the other one-way valve 912 to the second inner cavity 102. Then, part of the blood flows out through the outlet 2, and part of the blood can flow back to the first inner cavity 101 through the reflux channel 93. The refluxed blood can enter the filter membrane assembly 91 and the filter element assembly 3 again through the one-way valve on one side of the first inner cavity 101 for filtration. Under the reciprocating flow effect, the effect of circulating filtration is achieved, and it can also ensure that the blood entering through the inlet 1 is basically unfiltered, and the blood discharged from the outlet 2 is basically filtered. In this embodiment, the effective flow rate of the blood through the filter element assembly 3 and the filter membrane assembly 91 can be controlled by adjusting the frequency of the volume change of the flexible liquid bag 51 by an external force. In actual operation, the blood filtration speed is slightly faster than the blood inlet speed, so that the blood level in the first inner cavity 101 is lower than the blood level in the second inner cavity 102, and it will not occur that the blood entering the inlet 1 bypasses directly to the outlet 2 through the reflux channel 93 without being filtered, thereby controlling the blood purification efficiency.

[0025] In a preferred embodiment, the filter membrane assembly 91 is sealingly connected to the top cover S1 of the cylinder S. In addition to the one-way valves 912 on both sides, the filter membrane assembly 91 further includes membrane filaments 911 and a housing 913. The two one-way valves 912 are provided on the housing 913, and the membrane filaments 911 are installed between the two one-way valves 912 and located at the top of the filter element assembly 3. The membrane filaments 911 are used to separate plasma from blood cells in the blood, so that only plasma enters the cylinder S, and blood cells do not enter the cylinder S to directly contact the adsorbent in the filter element assembly, resulting in better safety performance. In this embodiment, the pore diameter of the membrane filaments can be set to 0.04 - 0.4 μm, and the thickness of the membrane filaments can be set to 30 - 300 μm. The one-way valves are provided to function as one-way conduction, allowing blood to flow into the interior of the filter membrane assembly 91 from the first inner cavity 101 in a one-way manner, and after filtration, passing through the other one-way valve 912 and flowing out to the second inner cavity 102, preventing the filtered blood from returning to the first inner cavity from the interior of the filter membrane assembly again and reducing the filtration efficiency.

[0026] In a preferred embodiment, the interior of the cylinder S includes an upper partition chamber 4 and a lower partition chamber 5. The filter element assembly 3 is disposed in the upper partition chamber 4, and the flexible liquid bag 51 is disposed in the lower partition chamber 5. A driving hole 7 is provided on the lower partition chamber 5, and the driving hole 7 is used to connect an air pump or an injection pump. Charging gas or liquid along the driving hole 7 using an air pump or an injection pump can occupy the volume of the lower partition chamber 5, thereby compressing the flexible liquid bag 51, causing the liquid in the flexible liquid bag 51 to enter the upper partition chamber 4 through the filter element assembly 3; conversely, using an air pump or an injection pump to extract the gas or liquid in the lower partition chamber 5 along the driving hole 7 can cause the liquid in the upper partition chamber 4 to pass through the filter element assembly 3 and then enter the flexible liquid bag 51. Charging or extracting fluid from the driving hole 7 can generate power to allow the liquid in the upper partition chamber 4 to enter or leave the filter element assembly 3. By changing the operating frequency and stroke of the air pump or injection pump, the effective flux of blood passing through the filter element assembly 3 can be affected, improving the performance of blood filtration.

[0027] In one embodiment of the present application, the filter element assembly 3 includes a filter element formed body 31 and a filter membrane 32 wrapped around the outer periphery of the filter element formed body 31. A plasma channel 33 is formed with a hollow inside the filter element formed body 31, and the plasma channel 33 communicates with the flexible liquid sac 51. Preferably, the filter element formed body 31 is designed in the shape of a hollow cylinder, and the filter membrane 32 is wrapped and covered on the outer wall of the hollow cylinder. In this embodiment, blood is forced to pass through the filter membrane 32 and enter the filter element formed body 31. Due to the blocking effect of the filter membrane, the blood cells in the blood do not directly contact the adsorbent in the filter element formed body 31, and the safety performance is better. In this embodiment, the pore diameter of the filter membrane can be designed to be 1 μm - 10 μm, and the thickness of the filter membrane is set to be 60 μm - 600 μm; the adsorbent in the filter element formed body 31 includes at least one material of activated carbon and adsorption resin with a particle size of 20 μm - 200 μm, and is formed by fiber bonding. Selecting a fiber-bonded filter element as the filter element formed body 31 instead of extruding or sintering activated carbon can significantly reduce the problem of plastic microparticles entering the blood. The particle size of the adsorbent that can be selected for the filter element formed body 31 is much wider, and the powder adsorbent can also be used safely, thereby broadening the selection range of the adsorbent. The formed body prepared from the fine-particle-size adsorbent material has much better mass transfer performance than the large-particle-size loose-packed filter material. Compared with the existing loose-packed filter material adsorbent in this embodiment, the generation of dust and the requirement for coating are effectively reduced, so the manufacturing cost is reduced. The liquid in the flexible liquid sac 51 does not exchange with the fluid in the lower cavity 5, and has high safety.

[0028] In one embodiment of the present application, a baffle 6 is provided between the upper cavity 4 and the lower cavity 5. The baffle 6 is hermetically connected to the outer wall of the cylinder S. A connecting pipe 61 is provided on the baffle 6, and the plasma channel 33 communicates with the flexible liquid sac 51 through the connecting pipe 61. Further, the flexible liquid sac 51 is hermetically connected to the lower end of the connecting pipe 61. The outer side of the flexible liquid sac 51 is hermetically arranged between the lower cavity 5 and the baffle 6. When the driving hole 7 is externally connected to an air pump, the influence of air pressure on the volume change of the flexible liquid sac 51 can be better controlled.

[0029] In one embodiment of the present application, a sealing partition 34 is provided at the top of the filter element assembly 3 for covering the filter element formed body 31 and the plasma channel 33. The function of the sealing partition 34 is to prevent blood from directly entering and exiting the flexible liquid sac 51 through the plasma channel 33 without passing through the filter element assembly 3.

[0030] In one embodiment of the present application, there is a flow gap 8 between the sealing partition 34 at the top of the filter element assembly and the top cover S1 of the upper cavity 4, and blood can flow to the filter membrane assembly 91 through the flow gap 8.

[0031] The above are only specific embodiments of the present invention. Under the above teachings of the present invention, those skilled in the art can make other improvements or deformations based on the above embodiments. Those skilled in the art should understand that the above specific description is only a better explanation of the purpose of the present invention, and the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. A hemoperfusion cartridge, comprising a cylinder, characterized in that, A filter element assembly is arranged inside the cylinder body. A flexible blood bag is arranged at the top of the cylinder body. A flexible liquid bag is arranged inside the cylinder body. The inside of the flexible liquid bag is communicated with the inside of the filter element assembly. The volume of the flexible liquid bag can change under the action of an external force. A filter membrane assembly is arranged inside the flexible blood bag. The inside of the filter membrane assembly is communicated with the inside of the filter element assembly. An inlet and an outlet are arranged on the flexible blood bag. Two one-way valves are respectively arranged on both sides of the filter membrane assembly and are arranged in the same direction. A partition is arranged inside the blood bag. One end of the partition is hermetically connected to the blood bag. A reflux channel is formed between the other end of the partition and the filter membrane assembly. The partition and the filter membrane assembly divide the inside of the blood bag into a first inner cavity and a second inner cavity. After blood enters the first inner cavity through the inlet, it flows into the cylinder body through one of the one-way valves. After the blood is filtered by the filter membrane assembly and the filter element assembly, it flows through the other one-way valve to the second inner cavity. Then, part of the blood flows out through the outlet, and part of the blood can flow back to the first inner cavity through the reflux channel.

2. The hemoperfusion cartridge according to claim 1, wherein, The filter membrane assembly is hermetically connected to the top cover of the cylinder body. The filter membrane assembly further includes membrane filaments and a housing. The two one-way valves are arranged on the housing. The membrane filaments are installed between the two one-way valves and are located at the top of the filter element assembly. The membrane filaments are used to separate plasma and blood cells in the blood.

3. The hemoperfusion cartridge according to claim 1, wherein, The partition is a heat-sealed line.

4. The hemoperfusion cartridge according to claim 2, wherein, The inside of the cylinder body includes an upper partition cavity and a lower partition cavity. The filter element assembly is arranged in the upper partition cavity. The flexible liquid bag is arranged in the lower partition cavity. A driving hole is arranged on the lower partition cavity. The driving hole is used to connect an air pump or an injection pump.

5. The hemoperfusion cartridge according to claim 4, wherein, The filter element assembly includes a filter element formed body and a filter membrane covering the periphery of the filter element formed body. A plasma channel is formed by hollowing out the inside of the filter element formed body. The plasma channel is communicated with the flexible liquid bag.

6. The hemoperfusion cartridge according to claim 5, wherein, The filter element formed body is in the shape of a hollow cylinder. The filter membrane wraps and covers the outer wall of the hollow cylinder.

7. The hemoperfusion cartridge according to claim 5, wherein, A baffle is arranged between the upper partition cavity and the lower partition cavity. The baffle is hermetically connected to the outer wall of the cylinder body. A connecting pipe is arranged on the baffle. The flexible liquid bag is hermetically connected to the lower end of the connecting pipe. The plasma channel is communicated with the flexible liquid bag through the connecting pipe.

8. The hemoperfusion cartridge according to claim 5, wherein, A sealing partition is arranged at the top of the filter element assembly for covering the filter element formed body and the plasma channel. There is a flow-through gap between the sealing partition and the top cover of the upper partition cavity. Blood can flow through the flow-through gap to the filter membrane assembly.

9. The hemoperfusion cartridge according to any one of claims 5-8, characterized in that, The pore diameter of the membrane filaments is 0.04 μm - 0.4 μm, the thickness of the membrane filaments is 30 μm - 300 μm, the pore diameter of the filter membrane is 1 μm - 10 μm, and the thickness of the filter membrane is 60 μm - 600 μm.

10. The hemoperfusion cartridge according to any one of claims 5-8, characterized in that, The filter element formed body contains at least one of activated carbon and adsorption resin with a particle size of 20 μm - 200 μm and is formed by bonding with fibers.

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