An oxygenator

Abstract

The oxygenator of the present invention comprises at least one oxygenation unit, comprising an inlet, an oxygenation section, and an outlet. The oxygenation section comprises two stacked oxygenation membranes, a support portion disposed between the inner sides of the two oxygenation membranes, the region between the support portion and the two oxygenation membranes forming a blood flow channel, and a pressure plate disposed on each outer side of the two oxygenation membranes. The oxygenation membranes of the oxygenator of the present invention are made of polydimethylsiloxane, which exhibits excellent breathability and facilitates gas exchange in the blood. An ultrathin blood passage is formed between the two oxygenation membranes, and the pressure plates on the outer sides of the oxygenation membranes can precisely adjust the thickness of the blood passage, thereby achieving efficient gas exchange. The oxygenator of the present invention has a small pre-charge volume and a low pressure drop, making it easy to use. This solves the technical problems of prior art oxygenators, such as large pre-charge volumes, bulk, and poor portability.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and in particular to an oxygenator. Background Art

[0002] Extracorporeal membrane oxygenation (ECMO) is also known as Extracorporeal life support (ECLS). An artificial extracorporeal circulation device is composed of a circulating blood pump and an extracorporeal oxygenator as the core, which provides cardiopulmonary support for the purpose of extracorporeal alternative gas exchange support and heart replacement support. At the same time, it can reduce the requirements of critically ill patients for other conventional cardiopulmonary support measures, reduce vasoactive drugs and mechanical ventilation parameters, and buy time for the recovery of cardiopulmonary function. Since the outbreak of COVID-19, ECMO has played an important role in supporting critically ill COVID-19 patients. The membrane oxygenator is a key component of the extracorporeal membrane oxygenation system, which is used to remove carbon dioxide from the blood and absorb oxygen. The blood and the gas environment are separated by a layer of oxygenation membrane to reduce blood damage. The oxygenation membrane material in the common oxygenator on the market is a hollow fiber membrane of polymethylpentene. The dense outer layer of this oxygenation membrane can effectively reduce plasma leakage and extend the life of the oxygenator. However, this oxygenator still has disadvantages such as large priming volume and large pressure drop, and may also cause thrombosis during use. In addition, current ECMO systems are large and difficult to port. Summary of the Invention

[0003] The purpose of the present invention is to provide an oxygenator that solves the technical problems of the prior art oxygenator such as large pre-fill volume, large volume and poor portability.

[0004] In order to solve the above technical problems, the technical solution of the present invention is:

[0005] The oxygenator of the present invention comprises at least one oxygenation unit, which comprises an inlet, an oxygenation portion and an outlet. The oxygenation portion comprises two stacked oxygenation membranes, and a blood flow channel is formed in the area between the two oxygenation membranes.

[0006] Preferably, in the above-mentioned oxygenator, an oxygenation portion shell is provided between the outer sides of the two layers of oxygenation membranes and the pressure plate, the oxygenation portion shell is provided with a window to expose the oxygenation membrane, and a pressure plate is provided on each outer side of the oxygenation portion, and the pressure plate is provided on the outer side of the oxygenation membrane exposed by the window, and is used for exchanging gas between the oxygenation membrane and the gas.

[0007] Preferably, in the above oxygenator, the oxygenation portion further comprises a support portion provided in the blood flow channel between the inner sides of the two oxygenation membranes, and the support portion is a woven mesh or a boss structure formed by micro-nano processing.

[0008] Preferably, in the above oxygenator, the pressing plate is woven or laser engraved, and has a mesh or hollow structure.

[0009] Preferably, the above oxygenator further comprises a platen gap adjusting device provided on the edge of the platen to adjust the distance between the two platens, and the platen gap adjusting device comprises a pressure head and a pressure head control device.

[0010] Preferably, in the above oxygenator, the inflow portion and the outflow portion have the same structure, the inflow portion includes a circular hole end and a flat end, and the flow channel cross-sectional area of ​​the flat end is greater than or equal to the flow channel cross-sectional area of ​​the circular hole end.

[0011] Preferably, in the above oxygenator, an inlet guide plate is provided in the inlet portion and an outlet guide plate is provided in the outlet portion.

[0012] Preferably, in the above oxygenator, the oxygenation membrane is made of polydimethylsiloxane material.

[0013] Preferably, in the above-mentioned oxygenator, the oxygenator further comprises an oxygenator housing, a gas chamber enclosed by the oxygenator housing, a gas inlet, a gas outlet, a blood inlet and a blood outlet, at least one oxygenation unit is located in the gas chamber, the blood inlet and the blood outlet are connected to the at least one oxygenation unit through a blood flow channel, and the gas inlet is connected to the air-oxygen mixer.

[0014] Preferably, in the above oxygenator, the oxygenator is connected to a temperature control device, and both ends of the oxygenation unit are connected to a sensor module, which integrates a pressure sensor, a temperature sensor, a flow sensor, a bubble sensor and a blood oxygen saturation sensor.

[0015] Beneficial effects of the present invention:

[0016] The oxygenator's oxygenation membrane is made of polydimethylsiloxane, a material with excellent air permeability, facilitating blood gas exchange. An ultrathin blood passage is formed between the two layers of oxygenation membrane, and a pressure plate on the outer surface of the membrane precisely adjusts the thickness of the blood passage, thereby regulating the oxygenator's specific surface area and oxygenation efficiency, achieving efficient gas exchange. This oxygenator more closely resembles the physiological structure of the alveoli, with a small priming volume and minimal pressure drop, making it easy to use. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to more clearly illustrate the specific implementation of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for the specific implementation or the description of the prior art.

[0018] Figure 1 is a cutaway view of the oxygenation unit of the present invention;

[0019] Figure 2is a cross-sectional view of the oxygenation unit and oxygenation portion of the present invention;

[0020] Figure 3 is an exploded schematic diagram of the oxygenation unit of the present invention;

[0021] Figure 4 is a schematic structural diagram of the oxygenation unit of the oxygenator of the present invention;

[0022] Figure 5 It is the woven mesh structure support part in the oxygenation unit;

[0023] Figure 6 It is a combination structure of two layers of oxygenation membrane and a middle support part with a woven mesh structure;

[0024] Figure 7 Schematic diagram of the explosion of two oxygenated membranes and the boss structure therein;

[0025] Figure 8 Schematic diagram of the combination of two layers of oxygenated membranes and the boss structure therein;

[0026] Figure 9 Schematic diagram of the explosion of the oxygenation unit with a pressure plate on the outside;

[0027] Figure 10 Schematic diagram of an oxygenation unit with a pressure plate on the outside;

[0028] Figure 11 is the structure of a pressure plate in a preferred embodiment;

[0029] Figure 12 is the structure of the pressure plate in another preferred embodiment;

[0030] Figure 13 is a schematic diagram of a pressure plate gap adjustment device;

[0031] Figure 14 Schematic diagram of the structure of the inflow part of the oxygenation unit;

[0032] Figure 15 is a schematic structural diagram of an oxygenator comprising multiple oxygenation units;

[0033] Figure 16 Schematic diagram of the oxygenation unit with sensor modules at both ends.

[0034] Description of the reference numerals in the accompanying drawings:

[0035] 10: Inflow part; 11: Inflow port; 12: Inflow part guide plate; 20: Oxygenation part; 21: Oxygenation membrane; 22: Support part; 23: Oxygenation part shell; 24: Window; 30: Outflow part; 31: Outflow port; 32: Outflow part guide plate; 100: Oxygenation unit; 213: Blood passage.

[0036] 221: Braided silk; 222: Braided mesh pores.

[0037] 211: Boss structure; 212: Microchannel.

[0038] 25: pressing plate; 251: pressing plate supporting rib; 252: pressing plate supporting rib pores; 253: pressing plate edge; 254: pressing plate body; 255: micropores.

[0039] 26: Platen gap adjustment device; 261: Press head; 262: Press head control device.

[0040] 101: the round hole end of the inflow portion; 102: the flat end of the inflow portion.

[0041] 50: oxygenator; 51: oxygenator housing; 52: gas chamber; 53: gas inlet; 54: gas outlet; 55: blood inlet; 56: blood outlet; 57: temperature control device; 58: pressure sensor; 59: blood flow channel.

[0042] 40: Sensor module. DETAILED DESCRIPTION

[0043] To make the objectives, technical solutions and advantages of the embodiments of the present invention more clear, 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.

[0044] The oxygenator of the present invention is a flat membrane oxygenator, comprising at least one oxygenation unit. When a plurality of oxygenation units 100 are included, the plurality of oxygenation units 100 are connected in series or in parallel or in a combination of series and parallel through pipelines to form the oxygenator. Figures 1 to 4 As shown, the oxygenation unit 100 includes an inflow section 10, an oxygenation section 20, and an outflow section 30. Blood enters the oxygenation section 20 from the inflow section 10 through the inflow port 11. The oxygenation section 20 includes two stacked oxygenation membranes 21. A blood flow channel is formed in the area between the two oxygenation membranes 21. Gas exchange occurs between the external gas and the blood in the oxygenation section 20, and then the blood flows out of the oxygenator from the outflow section 30 through the outflow port 31.

[0045] The oxygenation unit 20 comprises two stacked oxygenation membranes 21, a support portion 22 positioned between the inner sides of the two oxygenation membranes 21, and an oxygenation unit housing 23 positioned outside the two oxygenation membranes 21. The oxygenation unit housing 23 is provided with windows 24, exposing the oxygenation membranes 21 to facilitate gas exchange. The inner regions of the two oxygenation membranes 21 serve as blood passages 213, while the outer regions are exposed to air, oxygen, or a mixture of the two through the windows 24. The oxygenator of the present invention is symmetrically arranged on its upper and lower sides, centered around the plane of the support portion 22. For example, a layer of oxygenation membrane 21 is positioned on each of the upper and lower sides of the support portion 22, and pressure plates 25 (described in detail below) are provided on the oxygenation unit housing 23 and on the outer sides of the oxygenation membranes 21 exposed through the windows 24.

[0046] The support portion 22 is a woven mesh structure ( Figure 5 and Figure 6 ) or a boss structure 211 formed by micro-nano processing ( Figure 7 and Figure 8 ), the support portion 22 and the area between the upper and lower oxygenation membranes 21 form a blood passage. The support portion 22 can prevent the two membranes from sticking together to block blood flow, and can also make the blood more evenly distributed in the blood flow channel. Figure 5 As shown, the support portion 22 is a woven mesh structure, including woven wires 221 and woven mesh pores 222, and the woven wires 221 are metal or polymer filaments. The woven mesh support structure can also disturb the blood flow and increase the oxygenation efficiency. Preferably, as Figure 7 and Figure 8 As shown, the support portion has a boss structure 211 , and the micro-channel 212 formed between the boss structure 211 and the oxygenation membrane 21 serves as a blood passage.

[0047] A pressure plate 25 is provided on each side of the oxygenation portion 20. Figure 9 and Figure 10 As shown, the pressure plate 25 is specifically arranged on the outside of the oxygenation membrane 21 exposed through the window 24 of the oxygenation unit housing 23. The pressure plate 25 can adjust the spacing to achieve pressure adjustment of the oxygenation unit by the pressure plate, and can accurately adjust the thickness of the blood passage, thereby achieving efficient gas exchange. The pressure plate 25 is woven or laser engraved, and has a mesh or hollow structure, which is breathable. The distance between the oxygenation membranes 21 on both sides of the oxygenation unit 100 needs to be precisely controlled to ensure that the blood layer is not too thick and does not hinder blood flow. In a preferred embodiment, the thickness of the blood passage is maintained by balancing the blood pressure and the external gas pressure.

[0048] like Figure 11 As shown, it is a schematic structural diagram of a preferred embodiment of the pressing plate 25, the pressing plate 25 includes a pressing plate support rib 251, a pressing plate support rib hole 252 and a pressing plate edge 253;

[0049] Figure 12 2 is a schematic structural diagram of another preferred embodiment of a pressing plate, comprising a pressing plate body 254 and micro-holes 255, wherein the micro-holes 255 can be formed by laser cutting.

[0050] In a preferred embodiment, Figure 13 As shown, a platen gap adjustment device 26 is provided for adjusting the spacing between the platens 25. Preferably, the platen gap adjustment device 26 is provided on the edge of the platen 25. The platen gap adjustment device 26 includes a pressure head 261 and a pressure head control device 262. The pressure head control device 262 can be manually adjusted or electrically adjusted and is used in conjunction with a pressure sensor.

[0051] The inflow portion 10 and the outflow portion 30 of the oxygenation unit 100 have the same structure, and the inflow portion 10 and the outflow portion 30 are symmetrically arranged at both ends of the oxygenation portion 20. Figure 14 As shown, the inflow portion 10 includes a circular hole end 101 and a flat end 102. The circular hole end 101 is the end of the tubular section of the inflow portion 10, and the flat end 102 is the end of the triangular flat section of the inflow portion 10. The flat end 102 is adjacent to and connected to the oxygenation portion 20. The flow channel cross-sectional area of ​​the flat end 102 is greater than or equal to the flow channel cross-sectional area of ​​the circular hole end 101. Blood flows into the inflow portion 10 from the circular hole end 101 and flows out from the flat end 102 into the oxygenation portion 20.

[0052] The inlet portion 10 has an inlet guide plate 12 and the outlet portion 30 has an outlet guide plate 32. Figure 3 shown.

[0053] The oxygenation section housing 23, inflow section 10, and outflow section 30 are integrally formed, with acrylic being an optional material. The oxygenation membrane 21 is made of polydimethylsiloxane, which has excellent breathability and facilitates gas exchange in the blood. In another preferred embodiment, the oxygenation membrane 21, inflow section 10, and outflow section 30 are integrally formed and all made of polydimethylsiloxane. The inner surfaces of the inflow section 10, outflow section 30, and oxygenation section 20 are coated with an anti-coagulant coating. The coating material may be heparin, albumin, polyethylene glycol (PEG), phosphorylcholine, or a zwitterionic polymer coating.

[0054] like Figure 15 As shown, in a preferred embodiment, the oxygenator 50 includes: an oxygenator housing 51, a gas chamber 52 enclosed by the oxygenator housing 51, a plurality of sheet-like oxygenation units 100 located in the gas chamber 52, a gas inlet 53, a gas outlet 54, a blood inlet 55, and a blood outlet 56. The outer surface of the oxygenator housing 51 is generally rectangular.

[0055] The blood inlet 55 and blood outlet 56 are connected to each oxygenation unit 100 via a blood flow channel 59. The gas inlet 53 is connected to an air-oxygen mixer, which provides a mixture of air and oxygen in a certain ratio. The direction of the blood flow channel 59 between the blood inlet 55 and blood outlet 56 is perpendicular to the direction of the gas passage between the gas inlet 53 and gas outlet 54. Preferably, the gas inlet 53 and gas outlet 54 are respectively located on the left and right sides of the oxygenator housing 51, and the blood inlet 55 and blood outlet 56 are respectively located on the top and bottom surfaces of the oxygenator housing 51.

[0056] The gas chamber 52 may be transparent, and the pressure therein may be adjusted. A pressure sensor 58 is provided inside the gas chamber 52 to sense and display the pressure of the gas chamber 52 .

[0057] A temperature control device 57 is provided outside the oxygenator's gas chamber 52 to maintain a constant temperature for the blood flowing through the oxygenator. Preferably, a blood oxygen saturation sensor, pressure sensor, flow sensor, temperature sensor, bubble sensor, or other sensor units may also be installed on the temperature control device 57.

[0058] like Figure 16 As shown, the oxygenation unit 100 is connected to a sensor module 40 at both ends. The sensor module 40 can integrate multiple sensors such as a pressure sensor, a temperature sensor, a flow sensor, a bubble sensor, and a blood oxygen saturation sensor for monitoring parameters such as blood pressure, temperature, flow, bubbles, venous blood oxygen saturation, hematocrit, and hemoglobin.

[0059] The oxygenator of the present invention has a small pre-fill volume and a small pressure drop, making it easy to use. The oxygenation membrane is made of polydimethylsiloxane material with good air permeability, which facilitates gas exchange in the blood. An ultra-thin blood passage is formed between the two layers of oxygenation membrane, and the thickness of the blood passage can be precisely adjusted, thereby achieving efficient gas exchange. The oxygenator of the present invention has a structure that is more similar to physiological alveoli, and the ultra-thin blood passage in the oxygenation part is similar to the capillary network of the alveoli. The air pressure in the gas chamber is adjustable, and combined with the adjustable pressure plate spacing, the entire air path system is also closer to the expansion and contraction effects of the alveoli. These features enable the oxygenator of the present invention to have a larger specific surface area, smaller resistance and pressure drop, higher gas exchange efficiency, and a smaller pre-fill volume. The use of an anti-coagulation coating also makes the oxygenator have good biocompatibility.

[0060] The above embodiments are only specific implementation methods of the present invention, which are used to illustrate the technical solutions of the present invention, rather than to limit them. The protection scope of the present invention is not limited thereto. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that any person skilled in the art can modify or improve the technical solutions described in the above embodiments within the technical scope disclosed by the present invention, or replace some of the technical features therein with equivalents. Such modifications, changes or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention, and should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention should be based on the protection scope of the claims.

Claims

1. An oxygenator, characterized in that The invention comprises at least one oxygenation unit (100), wherein the oxygenation unit (100) comprises an inflow portion (10), an oxygenation portion (20) and an outflow portion (30), wherein: The oxygenation portion (20) includes two stacked oxygenation membranes (21), wherein a blood flow channel is formed in the area between the inner sides of the two oxygenation membranes (21), wherein the oxygenation membranes (21) are made of polydimethylsiloxane material; An oxygenation portion shell (23) is provided on the outside of the two layers of the oxygenation membrane (21), a window (24) is provided on the oxygenation portion shell (23) to expose the oxygenation membrane (21), and a pressure plate (25) is provided on each of the two outer sides of the oxygenation portion (20), the pressure plate (25) is provided on the outside of the oxygenation membrane (21) exposed through the window (24), and a pressure plate gap adjustment device (26) is provided on the edge of the pressure plate (25) to adjust the distance between the two pressure plates (25), the pressure plate gap adjustment device (26) includes a pressure head (261) and a pressure head control device (262), and the pressure head control device (262) is electrically adjustable; The oxygenation portion (20) further includes a support portion (22) disposed in the blood flow channel between the inner sides of the two layers of the oxygenation membrane (21), wherein the support portion (22) is a woven mesh structure or a boss structure (211) formed by micro-nano processing; The oxygenator further comprises an oxygenator housing (51), a gas chamber (52) surrounded by the oxygenator housing (51), a gas inlet (53) and a gas outlet (54) arranged on the left and right sides of the oxygenator housing (51), and a blood inlet (55) and a blood outlet (56) arranged on the top and bottom surfaces of the oxygenator housing (51), wherein the at least one oxygenation unit (100) is located in the gas chamber (52), the blood inlet (55) and the blood outlet (56) are connected to the at least one oxygenation unit (100) via a blood flow channel (59), and the gas inlet (53) is connected to an air-oxygen mixer; The pressure in the gas chamber (52) is adjustable, and a pressure sensor (58) is provided inside the gas chamber (52); The oxygenator is connected to a temperature control device (57), and both ends of the oxygenation unit (100) are connected to a sensor module (40), wherein the sensor module (40) is integrated with a pressure sensor, a temperature sensor, a flow sensor, a bubble sensor, and a blood oxygen saturation sensor; The pressure head control device (262) is used in conjunction with the pressure sensor.

2. The oxygenator according to claim 1, characterized in that The pressing plate (25) is formed by weaving or laser engraving, and the pressing plate (25) has a mesh or hollow structure.

3. The oxygenator according to claim 1, wherein: The inflow portion (10) has the same structure as the outflow portion (30), and the inflow portion (10) comprises a circular hole end (101) and a flat end (102), wherein the flow channel cross-sectional area of ​​the flat end (102) is greater than or equal to the flow channel cross-sectional area of ​​the circular hole end (101).

4. The oxygenator according to claim 1, wherein The inflow portion (10) has an inflow portion guide plate (12), and the outflow portion (30) has an outflow portion guide plate (32).

5. The oxygenator according to claim 1, wherein When the oxygenator includes a plurality of oxygenation units (100), the plurality of oxygenation units (100) are connected in series or in parallel or in a combination of series and parallel through pipelines to form the oxygenator.

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