An oxygenator and its preparation method

Abstract

An oxygenator, comprising: a housing and a membrane group, a first sealing part and a second sealing part arranged in the housing cavity. The membrane group includes a plurality of flat membrane units and a plurality of hollow fiber membrane groups arranged alternately in layers. The hollow fiber membrane group includes heat-exchangeable hollow fiber membrane units and oxygenation hollow fiber membrane units arranged side by side. On both sides of the hollow fiber openings, the second sealing part seals the outer edges of the plurality of flat membrane units and the plurality of hollow fiber membrane groups arranged in layers; the first sealing part sequentially seals the edges of two adjacent flat membrane units arranged in layers parallel to the longitudinal axis of the hollow fiber membrane filament bundle. The two adjacent flat membrane units after sealing form a flat membrane group, and each two adjacent flat membrane groups are separated by a layer of hollow fiber membrane group. Through the cooperation of the sealing part with the plurality of flat membrane units and hollow fiber membrane groups arranged in a cross-layered manner, the oxygenator increases the gas exchange area, can effectively improve the blood-gas exchange efficiency, and improve the treatment rate.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to an oxygenator and a preparation method thereof. Background Art

[0002] Extracorporeal membrane oxygenation (ECMO) is an extracorporeal circulation system with both heart and lung assist functions. It is an essential medical device for cardiac and pulmonary surgeries, acute respiratory diseases, and rescuing critically ill patients, and is the last barrier to protect patients' lives. The membrane oxygenator, also known as an artificial lung, is a key core component in the ECMO system and is used to replace the lung function to oxygenate the blood and expel carbon dioxide.

[0003] Although the ECMO membrane lungs currently used in clinics have treated many patients, they still have disadvantages such as low gas-blood exchange efficiency of the oxygenation membrane filaments, easy blood coagulation to form thrombus, and easy contamination of the pipeline, resulting in frequent replacement of consumables. Therefore, it is necessary to develop new membrane oxygenator technologies to improve the oxygenation efficiency of the blood and provide more efficient and economical equipment support for the treatment of clinical critical and severe medicine. Summary of the Invention

[0004] The purpose of the present invention is to provide an oxygenator and a preparation method thereof. The oxygenator, through the cooperation of a sealing part with multiple cross-layered flat membrane units and hollow fiber membrane groups, increases the gas exchange area, can effectively improve the gas-blood exchange efficiency, and improve the treatment rate.

[0005] To solve the above technical problems, the technical solution of the present invention is as follows:

[0006] According to one aspect of the present invention, there is provided an oxygenator, comprising: a housing, and a membrane group, a first sealing part, and a second sealing part disposed in the cavity of the housing. The membrane group includes multiple flat membrane units and multiple hollow fiber membrane groups that are alternately stacked. Each hollow fiber membrane group includes a heat-exchangeable hollow fiber membrane unit and an oxygenation hollow fiber membrane unit arranged side by side. On both sides where the membrane filaments of the hollow fiber membrane group have openings, the second sealing part seals the outer edges of the multiple flat membrane units and the multiple hollow fiber membrane groups that are stacked, and exposes the membrane filament opening channels of the hollow fiber membrane group; the first sealing part sequentially seals the edges of two adjacent flat membrane units that are stacked parallel to the longitudinal axis of the hollow fiber membrane filaments of the hollow fiber membrane group. The two adjacent flat membrane units that are sealed form a flat membrane group, and each two adjacent flat membrane groups are separated by a layer of hollow fiber membrane group.

[0007] Preferably, in the above-mentioned oxygenator, the heat-exchangeable hollow fiber membrane unit includes 9 to 12 hollow fiber membrane bundles arranged side by side, the oxygenation hollow fiber membrane unit includes 98 to 113 hollow fiber membrane bundles arranged side by side, and the hollow fiber membrane bundles of both the heat-exchangeable hollow fiber membrane unit and the oxygenation hollow fiber membrane unit are braided in a twist shape and are composed of two or three hollow fiber membranes.

[0008] Preferably, in the above-mentioned oxygenator, the overall shape of the outer shell is a cuboid, including a left shell and a right shell close to the plane where the first sealant part is located, a front shell and a rear shell close to the plane where the second sealant part is located, and an opposite top shell and bottom shell.

[0009] Preferably, in the above-mentioned oxygenator, a blood inlet and a blood outlet are respectively provided on the left shell and the right shell; a temperature control medium inlet and a temperature control medium outlet are respectively provided at positions corresponding to the heat-exchangeable hollow fiber membrane unit on the front shell and the rear shell; a gas inlet and a gas outlet are respectively provided at positions corresponding to the oxygenation hollow fiber membrane unit on the front shell and the rear shell.

[0010] Preferably, in the above-mentioned oxygenator, the left shell and the right shell are end-cap-shaped shells. The end-cap-shaped shell includes an end face and a side face extending from the periphery of the end face. A first exhaust port is provided on the side face of the left shell coplanar with the top shell, and a second exhaust port is provided on the side face of the right shell coplanar with the top shell.

[0011] Preferably, in the above-mentioned oxygenator, the front shell, the bottom shell, the rear shell, and the top shell are integrally formed.

[0012] Preferably, in the above-mentioned oxygenator, the material of the heat-exchangeable hollow fiber membrane unit is polyethylene terephthalate; the material of the oxygenation hollow fiber membrane unit is polypropylene or polymethylpentene, and the material of the flat membrane unit is silicone rubber.

[0013] Preferably, in the above-mentioned oxygenator, the side length of the flat membrane unit is 110 mm to 150 mm, and the lengths of the heat-exchangeable hollow fiber membrane unit and the oxygenation hollow fiber membrane unit are 115 mm to 160 mm.

[0014] According to another aspect of the present invention, there is provided a method for preparing the above-mentioned oxygenator, comprising the following steps: S1: preparing a hollow fiber membrane module, and alternately stacking the hollow fiber membrane module and a flat membrane unit to form a membrane module; S2: injecting glue at the edges of the alternately stacked hollow fiber membrane module and flat membrane unit to form a first glue-sealing part and a second glue-sealing part; S3: cutting the second glue-sealing part to expose the membrane wire opening channels of the hollow fiber membrane module; cutting the first glue-sealing part so that the cut surface of each first glue-sealing part is on the same plane and does not damage the glue-sealed part; and S4: preparing a cuboid housing and fixing the membrane module in the cavity of the housing.

[0015] Preferably, in the above-mentioned method for manufacturing an oxygenator, in step S1, preparing the hollow fiber membrane module includes weaving a plurality of heat-exchangeable hollow fiber membrane units and oxygenation hollow fiber membrane units, cutting them according to dimensions, and placing the heat-exchangeable hollow fiber membrane units and oxygenation hollow fiber membrane units side by side to form a hollow fiber membrane module; in step S2, injecting glue at the outer edges of the stacked hollow fiber membrane module and flat membrane unit on both sides of the openings of the hollow fiber membrane filaments of the hollow fiber membrane module to form a second glue-sealing part, and sequentially injecting glue at the two side edges parallel to the longitudinal axis of the hollow fiber membrane filament bundle of two adjacent flat membrane units to form a first glue-sealing part. The two adjacent flat membrane units that are glued form a flat membrane module, and each two adjacent flat membrane modules are separated by a layer of hollow fiber membrane module, so that the first glue-sealing part is distributed in a strip shape.

[0016] The beneficial effects of the present invention are as follows:

[0017] The present invention provides a new membrane oxygenator technology to improve the oxygenation efficiency of blood. Through the cooperation of the glue-sealing part with a plurality of cross-stacked flat membrane units and hollow fiber membrane modules, the gas exchange area is increased, the gas-blood exchange efficiency can be effectively improved, the rescue rate is increased, and more efficient and economical equipment support is provided for the rescue in clinical critical care medicine. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art.

[0019] Figure 1 is an external schematic view of an oxygenator according to an embodiment of the present invention;

[0020] Figure 2 is an overall structural schematic view of an oxygenator according to an embodiment of the present invention;

[0021] Figure 3A is a cross-sectional view obtained on a plane parallel to the top surface housing of an oxygenator according to an embodiment of the present invention; Figure 3BSchematic structural diagram of the front side housing of an oxygenator according to an embodiment of the present invention;

[0022] Figure 4 Partial enlarged schematic diagram of partial sealant and structure of an oxygenator membrane module according to an embodiment of the present invention;

[0023] Figure 5 Top view of a hollow fiber membrane module of an oxygenator according to an embodiment of the present invention;

[0024] Figure 6 Schematic structural diagram of a hollow fiber membrane module woven from hollow fiber membrane filaments of an oxygenator according to an embodiment of the present invention;

[0025] Figure 7 Schematic structural diagram of blood passage, heat exchange passage and gas passage in the membrane module and sealant part of an oxygenator according to an embodiment of the present invention;

[0026] Figure 8 Partial enlarged schematic structural diagram of heat exchange passage and gas passage in the membrane module and sealant part of an oxygenator according to an embodiment of the present invention. Detailed implementation manners

[0027] To make the objectives, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention.

[0028] As Figures 1 to 8 shown, an oxygenator includes: a housing 20 and a membrane module (10), a first sealant part 16 and a second sealant part 34 disposed in the cavity of the housing 20.

[0029] The membrane module 10 includes a plurality of flat membrane units 17 and a plurality of hollow fiber membrane modules alternately stacked, as Figure 7 and Figure 8 shown. The flat membrane unit 17 is a single-layer flat membrane, and the hollow fiber membrane module includes heat-exchangeable hollow fiber membrane units 14 and oxygenation hollow fiber membrane units 15 arranged side by side (as Figure 4 and Figure 5 ), the heat-exchangeable hollow fiber membrane unit 14 contains 9 to 12 hollow fiber membrane filament bundles arranged side by side, each oxygenation hollow fiber membrane unit 15 includes 98 to 113 hollow fiber membrane filament bundles arranged side by side, and the hollow fiber membrane filament bundles are all braided in a twist shape and are woven from two or three hollow fiber membrane filaments, as Figure 6 shown.

[0030] The first sealant part 16 and the second sealant part 34 seal the outer edges of the stacked flat membrane units 17 and the hollow fiber membrane module (as Figure 4 and Figure 7); On both sides where the orifices of the hollow fiber membrane filaments in the hollow fiber membrane module are located, the second sealing portion 34 seals the outer edges of the stacked multiple flat membrane units 17 and the multiple hollow fiber membrane modules, and exposes the orifice channels of the hollow fiber membrane filaments of the hollow fiber membrane module ( Figure 4 and Figure 7 as shown); The first sealing portion 16 seals the edges of two adjacent stacked flat membrane units parallel to the longitudinal axis of the hollow fiber membrane filament bundle, and the first sealing portion 16 is strip-shaped ( Figure 2 and Figure 4 ). The two adjacent flat membrane units with sealing form a flat membrane module, and each two adjacent flat membrane modules are separated by a layer of hollow fiber membrane module, forming a blood passage 11 between the two adjacent flat membrane modules ( Figure 4 and Figure 7 ).

[0031] As Figure 2 shown, the membrane module 10 is fixed in the cavity of the housing 20. The overall shape of the outside of the housing 20 is a cuboid, including the opposite left housing 201 and right housing 202, the opposite front housing 203 and rear housing 204, and the opposite top housing 205 and bottom housing 206. Among them, the front housing 203, bottom housing 206, rear housing 204 and top housing 205 are integrally formed, and the left housing 201 and right housing 202 are end cap-shaped housings (as Figure 1 and Figure 2 shown), each including an end face and a side face extending from the periphery of the end face, and the side face extending from the periphery of the end face is coplanar with the corresponding one of the integrally formed front housing 203, bottom housing 206, rear housing 204 and top housing 205.

[0032] The end faces of the left housing 201 and right housing 202 are close to the plane where the first sealing portion 16 is located, forming a gap 33 for the blood passage, and the front housing 203 and rear housing 204 are close to the plane where the second sealing portion 34 is located, forming a gap 31 for the temperature control medium passage and a gap 32 for the gas passage (as Figure 3A shown). The heat exchangeable hollow fiber membrane units 14 and oxygenation hollow fiber membrane units 15 of each hollow fiber membrane module are arranged side by side in the direction from the left housing 201 to the right housing 202.

[0033] A blood inlet 21 and a blood outlet 22 are respectively provided on the left housing 201 and right housing 202, and both ends of the flat membrane unit 17 are respectively communicated with the blood inlet 21 and the blood outlet 22, forming a blood passage 11.

[0034] At positions corresponding to the heat-exchange hollow fiber membrane unit 14 on the front-side housing 203 and the rear-side housing 204, a temperature-control medium inlet 23 and a temperature-control medium outlet 24 are respectively provided. Both ends of the heat-exchange hollow fiber membrane unit 14 are respectively communicated with the temperature-control medium inlet 23 and the temperature-control medium outlet 24 to form a heat-exchange passage 12( Figure 4 and Figure 5 ).

[0035] At positions corresponding to the oxygenation hollow fiber membrane unit 15 on the front-side housing 203 and the rear-side housing 204, a gas inlet 25 and a gas outlet 26 are respectively provided. Both ends of the oxygenation hollow fiber membrane unit 15 are respectively communicated with the gas inlet 25 and the gas outlet 26 to form a gas passage 13. The direction of the blood passage 11 is perpendicular to the directions of the heat-exchange passage 12 and the gas passage 13.

[0036] A first exhaust port 271 is provided on the side surface of the left-side housing 201 that is coplanar with the top-surface housing 205, and a second exhaust port 272 is provided on the side surface of the right-side housing 202 that is coplanar with the top-surface housing 205, as Figure 1 and Figure 2 shown.

[0037] The material of the flat membrane unit 17 is silicone rubber, and the side length of each layer of the flat membrane unit is 110 mm to 150 mm; the material of the heat-exchange hollow fiber membrane unit 14 is polyethylene terephthalate; the material of the oxygenation hollow fiber membrane unit 15 is polypropylene or polymethylpentene; the lengths of the heat-exchange hollow fiber membrane unit 14 and the oxygenation hollow fiber membrane unit 15 are 115 mm to 160 mm.

[0038] Blood flows in from the blood inlet 21, enters the gap of the heat-exchange hollow fiber membrane unit 14 between adjacent flat membrane groups, and exchanges heat with the temperature-control medium flowing into the hollow fiber membrane filaments of the heat-exchange hollow fiber membrane unit 14 on the outer side of the hollow fiber membrane filaments and the surface of the flat membrane unit 17. Then the blood enters the oxygenation hollow fiber membrane unit 15 and passes through the outer side of the hollow fiber membrane filaments of the oxygenation hollow fiber membrane unit 15, and exchanges gas with the oxygen in the hollow fiber membrane filaments of the oxygenation hollow fiber membrane unit 15 through the outer side of the hollow fiber membrane filaments and the surface of the flat membrane unit 17. Finally, the blood is gathered to the blood outlet 22 and leaves the oxygenator.

[0039] A manufacturing method of an oxygenator includes the following steps:

[0040] S1: Prepare a hollow fiber membrane module and stack the hollow fiber membrane module and the flat membrane unit alternately to form a membrane module. Specifically, preparing the hollow fiber membrane module includes weaving a plurality of heat-exchangeable hollow fiber membrane units 14 and oxygenation hollow fiber membrane units 15, cutting them according to size, and placing the heat-exchangeable hollow fiber membrane units 14 and the oxygenation hollow fiber membrane units 15 side by side to form a hollow fiber membrane module.

[0041] S2: Glue the edges of the alternately stacked hollow fiber membrane module and the flat membrane unit to form a first sealing part 16 and a second sealing part 34. Specifically, on both sides of the openings of the hollow fiber membrane filaments in the hollow fiber membrane module, glue the outer edges of the stacked hollow fiber membrane module and the flat membrane unit 17 to form the second sealing part 34, and sequentially seal the two side edges parallel to the longitudinal axis of the hollow fiber membrane filament bundle of two adjacent flat membrane units 17 to form the first sealing part 16. The two adjacent flat membrane units that are sealed form a flat membrane group, and each two adjacent flat membrane groups are separated by a layer of hollow fiber membrane module. The first sealing part 16 is distributed in a strip shape.

[0042] S3: Cut the second sealing part 34 to expose the membrane filament opening channel of the hollow fiber membrane module; cut the first sealing part 16 so that the cut surface of each first sealing part 16 is on the same plane and does not damage the sealed part.

[0043] S4: Prepare a cuboid housing and fix the membrane module in the cavity of the housing. Preferably, use an integrally formed method to prepare the front housing, bottom housing, rear housing and top housing of the housing, and use a method of multiple single-sided gluing or welding to fix the left housing and the right housing of the housing to the side of the membrane module.

[0044] The above embodiments are only specific implementation manners of the present invention, used to illustrate the technical solutions of the present invention, rather than limiting it. The protection scope of the present invention is not limited thereto. Although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that: Any person skilled in the art within the technical scope disclosed by the present invention can still modify, change or replace the technical solutions recorded in the foregoing embodiments, or perform equivalent replacement on some of the technical features; and these modifications, changes or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present invention, and should all be covered by the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. An oxygenator, characterized in that, Comprising: A housing (20), a membrane group (10), a first sealant part (16) and a second sealant part (34) disposed in the cavity of the housing (20). The membrane group (10) includes a plurality of flat membrane units (17) and a plurality of hollow fiber membrane groups arranged in an alternating and laminated manner. Each hollow fiber membrane group includes a heat-exchangeable hollow fiber membrane unit (14) and an oxygenation hollow fiber membrane unit (15) arranged side by side. The hollow fiber membrane filaments of the heat-exchangeable hollow fiber membrane unit (14) and the oxygenation hollow fiber membrane unit (15) are both braided in a twist shape and are braided by two or three hollow fiber membrane filaments. On both sides where the membrane filaments of the hollow fiber membrane group are perforated, the second sealant part (34) seals the outer edges of the plurality of flat membrane units (17) and the plurality of hollow fiber membrane groups arranged in a laminated manner, and exposes the membrane filament opening channels of the hollow fiber membrane group. The first sealant part (16) sequentially seals the edges of two adjacent flat membrane units (17) arranged in a laminated manner parallel to the longitudinal axis of the hollow fiber membrane filaments of the hollow fiber membrane group. The two adjacent flat membrane units (17) being sealed form a flat membrane group, and each two adjacent flat membrane groups are separated by a layer of hollow fiber membrane group.

2. The oxygenator according to claim 1, characterized in that, The heat-exchangeable hollow fiber membrane unit (14) includes 9 to 12 hollow fiber membrane filament bundles arranged side by side, the oxygenation hollow fiber membrane unit (15) includes 98 to 113 hollow fiber membrane filament bundles arranged side by side, and the flat membrane unit (17) is a single-layer flat membrane.

3. The oxygenator according to claim 1, characterized in that, The exterior of the housing (20) is generally in the shape of a cuboid, including a left housing body (201) and a right housing body (202) adjacent to the plane where the first sealant part (16) is located, a front housing body (203) and a rear housing body (204) adjacent to the plane where the second sealant part (34) is located, and an opposite top housing body (205) and bottom housing body (206).

4. The oxygenator according to claim 3, characterized in that, A blood inlet (21) and a blood outlet (22) are respectively provided on the left housing body (201) and the right housing body (202); a temperature control medium inlet (23) and a temperature control medium outlet (24) are respectively provided at positions corresponding to the heat-exchangeable hollow fiber membrane unit (14) on the front housing body (203) and the rear housing body (204); a gas inlet (25) and a gas outlet (26) are respectively provided at positions corresponding to the oxygenation hollow fiber membrane unit (15) on the front housing body (203) and the rear housing body (204).

5. The oxygenator according to claim 3, characterized in that, The left housing body (201) and the right housing body (202) are end-cap-shaped housing bodies. The end-cap-shaped housing body includes an end face and a side surface extending from the periphery of the end face. A first exhaust port (271) is provided on the side surface of the left housing body (201) coplanar with the top housing body (205), and a second exhaust port (272) is provided on the side surface of the right housing body (202) coplanar with the top housing body (205).

6. The oxygenator according to claim 3, characterized in that, Wherein, The front side housing (203), the bottom surface housing (206), the rear side housing (204) and the top surface housing (205) are integrally formed.

7. The oxygenator according to claim 1, characterized in that, The material of the heat-exchangeable hollow fiber membrane unit (14) is polyethylene terephthalate; the material of the oxygenation hollow fiber membrane unit (15) is polypropylene or polymethylpentene, and the material of the flat membrane unit (17) is silicone rubber.

8. The oxygenator according to claim 1, characterized in that, The side length of the flat membrane unit (17) is 110 mm to 150 mm, and the lengths of the heat-exchangeable hollow fiber membrane unit (14) and the oxygenation hollow fiber membrane unit (15) are 115 mm to 160 mm.

9. The preparation method of the oxygenator according to claim 1, characterized in that, It includes the following steps: S1: Prepare a hollow fiber membrane group, and alternately stack and place the hollow fiber membrane group and the flat membrane unit to form a membrane group; S2: Glue the edges of the alternately stacked hollow fiber membrane group and the flat membrane unit to form a first sealing part and a second sealing part; S3: Cut the second sealing part to expose the membrane wire opening channels of the hollow fiber membrane group; cut the first sealing part so that the cut surfaces of each first sealing part are on the same plane and do not damage the sealed parts; S4: Prepare a cuboid housing and fix the membrane group in the cavity of the housing.

10. The manufacturing method of the oxygenator according to claim 1, wherein, In step S1, preparing the hollow fiber membrane group includes weaving a plurality of heat-exchangeable hollow fiber membrane units and oxygenation hollow fiber membrane units, cutting them according to dimensions, and placing the heat-exchangeable hollow fiber membrane units and the oxygenation hollow fiber membrane units side by side to form the hollow fiber membrane group; In step S2, on both sides of the openings of the hollow fiber membrane wires of the hollow fiber membrane group, glue the outer edges of the stacked hollow fiber membrane group and the flat membrane unit to form the second sealing part, and sequentially seal the two side edges parallel to the longitudinal axis of the hollow fiber membrane wire bundle of two adjacent flat membrane units to form the first sealing part. Two adjacent flat membrane units that are sealed form a flat membrane group, and each two adjacent flat membrane groups are separated by a layer of hollow fiber membrane group, so that the first sealing part is distributed in a strip shape.

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