CN114949410A - Oxygenator - Google Patents

Abstract

The oxygenator comprises at least one oxygenating unit, wherein the oxygenating unit comprises an inflow part, an oxygenating part and an outflow part, the oxygenating part comprises two layers of oxygenation membranes which are stacked, a supporting part is arranged between the inner sides of the two layers of oxygenation membranes, a blood flow channel is formed in the area between the supporting part and the two layers of oxygenation membranes, and a pressing plate is arranged on each of the outer sides of the two layers of oxygenation membranes of the oxygenating part. The oxygenator provided by the invention has the advantages that the oxygenator adopts a polydimethylsiloxane material, the oxygenator has good air permeability and is convenient for gas exchange of blood, an ultrathin blood passage is formed between the two layers of oxygenation membranes, and the pressing plate on the outer side of the oxygenation membranes can accurately adjust the thickness of the blood passage, so that the efficient gas exchange effect is realized.

Description

Oxygenator

Technical Field

The invention relates to the field of medical instruments, in particular to an oxygenator.

Background

Extracorporeal membrane oxygenation (ECMO) may also be referred to as Extracorporeal life support (ECLS). An artificial extracorporeal circulation device is formed by taking a circulating blood flow pump and an extracorporeal oxygenator as a core, and cardiopulmonary support with the purposes of extracorporeal alternative gas exchange support and cardiac alternative support is carried out. Meanwhile, the requirements of severe patients on other conventional cardiopulmonary support measures can be reduced, vasoactive drugs and mechanical ventilation parameters can be reduced, and time is won for the recovery of cardiopulmonary function. ECMO plays an important role in supporting COVID-19 critically ill patients since the COVID-19 outbreak. Membrane oxygenators are key components of extracorporeal membrane lung oxygenation systems for the removal of carbon dioxide and the uptake of oxygen in the blood. The blood and the gas environment are separated by an oxygen-containing film for reducing blood damage. The oxygenating membrane material in a common oxygenator on the market is a hollow fiber membrane of polymethylpentene. The compact layer of the outer layer of the oxygenation membrane can effectively reduce plasma leakage and prolong the service life of the oxygenator, but the oxygenator still has the defects of large precharge amount, large pressure drop and the like, and thrombus can be generated in the using process. In addition, the conventional ECMO system is large in size and poor in portability.

Disclosure of Invention

The invention aims to provide an oxygenator, which solves the technical problems of large pre-charging amount, large volume and poor portability of the oxygenator in the prior art.

In order to solve the technical problems, the technical scheme of the invention is as follows:

the oxygenator comprises at least one oxygenating unit, wherein the oxygenating unit comprises an inflow part, an oxygenating part and an outflow part, the oxygenating part comprises two layers of oxygenation membranes which are arranged in a stacked mode, and a blood flow channel is formed in a region between the two layers of oxygenation membranes.

Preferably, in the oxygenator, an oxygenating part housing is provided between the outer sides of the two layers of oxygenation membranes and the pressing plate, the oxygenating part housing is provided with a window to expose the oxygenation membranes, the two outer sides of the oxygenating part are respectively provided with one pressing plate, and the pressing plates are arranged on the outer sides of the oxygenation membranes exposed through the window and used for exchanging the oxygenation membranes with gas.

Preferably, in the oxygenator, the oxygenating part further includes a support part disposed in the blood flow channel between the inner sides of the two layers of oxygenation membranes, and the support part is a woven mesh or a boss structure formed by micro-nano processing.

Preferably, in the oxygenator, the pressing plate is formed by weaving or laser engraving, and the pressing plate has a mesh or hollow structure.

Preferably, in the oxygenator, a platen gap adjusting device disposed on an edge of the platen to adjust a distance between the two platens is further included, and the platen gap adjusting device includes a pressure head and a pressure head control device.

Preferably, in the oxygenator, the inflow part and the outflow part have the same structure, the inflow part comprises a round hole end and a flat end, and the cross-sectional area of the flow channel of the flat end is larger than or equal to that of the flow channel of the round hole end.

Preferably, in the oxygenator, the inflow portion includes an inflow portion baffle therein and the outflow portion includes an outflow portion baffle therein.

Preferably, in the oxygenator, the oxygenation membrane is made of polydimethylsiloxane material.

Preferably, in the above oxygenator, the oxygenator further includes an oxygenator housing, a gas chamber enclosed by the oxygenator housing, a gas inlet, a gas outlet, a blood inlet, and a blood outlet, the 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.

Preferably, in the above oxygenator, the oxygenator is connected with a temperature control device, and two ends of the oxygenation unit are connected with sensing modules, and the sensing modules are integrated with a pressure sensor, a temperature sensor, a flow sensor, a bubble sensor and a blood oxygen saturation sensor.

The invention has the beneficial effects that:

the oxygenation membrane of the oxygenator adopts polydimethylsiloxane material which has very good air permeability and is convenient for gas exchange of blood. An ultrathin blood passage is formed between the two layers of the oxygenation membranes, and the thickness of the blood passage can be accurately adjusted by the pressing plate on the outer side of the oxygenation membrane, so that the specific surface area and the oxygenation efficiency of the oxygenator can be regulated and controlled, and the efficient gas exchange effect is realized. The oxygenator is closer to the physiological structure of the alveolus, has small pre-charging amount and small pressure drop, and is convenient to use.

Drawings

In order to more clearly illustrate the detailed description of the invention or the technical solutions in the prior art, the drawings that are needed in the detailed description of the invention or the prior art will be briefly described below.

FIG. 1 is a cut-away view of an oxygenation unit of the invention;

FIG. 2 is a cross-sectional cutaway view of the oxygenation unit and oxygenation section of the present invention;

FIG. 3 is an exploded schematic view of the oxygenation unit of the present invention;

FIG. 4 is a schematic diagram of the configuration of the oxygenation unit of the oxygenator of the present invention;

FIG. 5 is a woven mesh support in the oxygenation unit;

fig. 6 is a composite structure of two layers of the oxygen-containing membrane and a woven mesh structure as the intermediate support;

fig. 7 is an exploded schematic view of two layers of an oxygen-containing membrane and a plateau formation therein;

fig. 8 is a schematic view of a combination of two layers of an oxygen-containing membrane and a plateau formation therein;

FIG. 9 is an exploded view of an oxygenation unit with a platen on the outside;

FIG. 10 is a schematic of an oxygenation unit with a platen on the outside;

FIG. 11 is a structure of a platen in a preferred embodiment;

FIG. 12 is a structure of a pressing plate in another preferred embodiment;

FIG. 13 is a schematic view of a platen gap adjustment arrangement;

FIG. 14 is a schematic view of the structure of the inflow part of the oxygenation unit;

fig. 15 is a schematic view of the construction of an oxygenator including a plurality of oxygenation units;

FIG. 16 is a schematic view of an oxygenation unit with sensing modules at both ends.

Reference numbers in the drawings illustrate:

10: an inflow section; 11: an inflow port; 12: an inflow portion guide plate; 20: an oxygenation section; 21: an oxygen-containing membrane; 22: a support portion; 23: an oxygenation section housing; 24: windowing; 30: an outflow section; 31: an outflow port; 32: a flow-out part guide plate; 100: an oxygenation unit; 213: blood passage.

221: weaving silk; 222: mesh grid pores are woven.

211: a boss structure; 212: a microchannel.

25: pressing a plate; 251: a pressure plate support rib; 252: the holes of the support ribs of the pressing plate; 253: the edge of the pressing plate; 254: pressing plate body; 255: and (4) micro-pores.

26: a platen gap adjustment device; 261: a pressure head; 262: and a pressure head control device.

101: a round hole end of the inflow portion; 102: a flat end of the inflow portion.

50: an oxygenator; 51: an oxygenator housing; 52: a gas chamber; 53: a gas inlet; 54: a gas outlet; 55: a blood inlet; 56: a blood outlet; 57: a temperature control device; 58: a pressure sensor; 59: a blood flow passage.

40: and a sensing module.

Detailed Description

In order to make the objects, 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 drawings in the embodiments of the present invention.

The oxygenator of the invention is a flat membrane oxygenator, which comprises at least one oxygenation unit, and when the oxygenator comprises a plurality of oxygenation units 100, the oxygenation units 100 are connected in series or in parallel or in a combination of series and parallel by pipelines to form the oxygenator. As shown in fig. 1 to 4, the oxygenation unit 100 includes an inflow portion 10, an oxygenation portion 20, and an outflow portion 30, blood enters the oxygenation portion 20 from the inflow portion 10 through an inflow port 11, the oxygenation portion 20 includes two layers of oxygenation membranes 21 stacked, a blood flow channel is formed in a region between the two layers of oxygenation membranes 21, ambient air is exchanged with the blood in the oxygenation portion 20, and then the blood flows out of the oxygenator from the outflow portion 30 through an outflow port 31.

The oxygenation section 20 includes: two layers of oxygenation membranes 21 which are arranged in a laminating way, a supporting part 22 which is arranged between the inner sides of the two layers of oxygenation membranes 21, and an oxygenation part shell 23 which is arranged at the outer side of the two layers of oxygenation membranes 21. The oxygenation section casing 23 is provided with a window 24, and the oxygenation membrane 21 is exposed through the window 24 for exchanging gas with the oxygenation membrane 21. The inner region of the two-layer oxygenation membrane 21 is the blood passageway 213 and the outer region is exposed to air or oxygen or a mixture of both through the fenestration 24. The oxygenator of the present invention is symmetrically arranged with the plane of the supporting portion 22 as the center, for example, the upper and lower sides of the supporting portion 22 are respectively provided with a layer of oxygenation membrane 21, an oxygenation portion housing 23, and a pressing plate 25 (described in detail below) on the outer side of the oxygenation membrane 21 exposed through the window 24.

The supporting part 22 is a woven net structure (fig. 5 and 6) or a boss structure 211 (fig. 7 and 8) formed by micro-nano processing, and a blood passage is formed between the supporting part 22 and the upper and lower layers of the oxygenation membranes 21. The support portion 22 prevents the two films from sticking together and prevents blood flow, and also allows blood to be distributed more evenly in the blood flow path. As shown in fig. 5, the supporting 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 support structure of the woven net can also generate disturbance to blood flow, and oxygenation efficiency is increased. Preferably, as shown in fig. 7 and 8, the support portion has a convex structure 211, and the microchannel 212 formed between the convex structure 211 and the oxygen-containing membrane 21 is a blood passage.

One pressing plate 25 is provided on each of both outer sides of the oxygenating portion 20, and as shown in fig. 9 and 10, the pressing plate 25 is specifically provided on the outer side of the oxygenating membrane 21 exposed through the window 24 of the oxygenating portion casing 23. The pressing plate 25 can adjust the distance, so that the pressure of the pressing plate on the oxygenation part can be adjusted, the thickness of the blood passage can be accurately adjusted, and the efficient gas exchange effect can be realized. The pressing plate 25 is formed by weaving or laser engraving, has a mesh or hollow structure, and has air permeability. 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 impede blood flow. In a preferred embodiment, the thickness of the blood passageway is maintained by a balance of blood pressure and ambient gas pressure.

As shown in FIG. 11, a schematic view of a preferred embodiment of the pressure plate 25, the pressure plate 25 includes pressure plate support ribs 251, pressure plate support rib apertures 252, and a pressure plate edge 253;

fig. 12 is a schematic diagram of another preferred embodiment of a platen, including a platen body 254 and micro-holes 255, wherein the micro-holes 255 may be formed by laser cutting.

In a preferred embodiment, shown in fig. 13, a platen gap adjusting device 26 is provided for adjusting the spacing of the platens 25, and preferably, the platen gap adjusting device 26 is provided on the edge of the platens 25. The platen gap adjustment mechanism 26 includes a ram 261 and a ram control mechanism 262, and the ram control mechanism 262 may be manually or electrically adjustable and used in conjunction with a pressure sensor.

The inflow unit 10 and the outflow unit 30 of the oxygenation unit 100 have the same structure, and the inflow unit 10 and the outflow unit 30 are symmetrically disposed at both ends of the oxygenation unit 20. As shown in fig. 14, the inflow portion 10 includes a round hole end 101 and a flat end 102, the round hole end 101 is an end of the tubular section of the inflow portion 10, the flat end 102 is an end of the triangular flat section of the inflow portion 10, the flat end 102 is adjacent to the oxygenation portion 20 and connected with the oxygenation portion 20, and the cross-sectional flow area of the flat end 102 is greater than or equal to that of the round hole end 101. The blood flows in from the circular hole end 101 of the inflow portion 10 and flows out from the flat end 102 into the oxygenation portion 20.

The inflow portion 10 has an inflow portion baffle 12 therein and the outflow portion 30 has an outflow portion baffle 32 therein, as shown in fig. 3.

The oxygenation housing 23 and the inflow 10 and outflow 30 sections are integrally formed, and an alternative material is acrylic. The oxygen-containing membrane 21 is made of polydimethylsiloxane material, has very good air permeability and is convenient for gas exchange in blood. In another preferred embodiment, the oxygen-containing membrane 21, the inflow portion 10, and the outflow portion 30 are integrally formed and made of polydimethylsiloxane material. The inner surfaces of the inflow part 10, the outflow part 30 and the oxygenation part 20 are provided with anticoagulant coatings, and the coating material can be a heparin coating, or can be an albumin, polyethylene glycol (PEG), phosphorylcholine or a zwitterionic polymer coating.

As shown in fig. 15, 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 and a gas outlet 54, a blood inlet 55 and a blood outlet 56. The oxygenator case 51 has a rectangular parallelepiped shape as a whole.

The blood inlet 55 and the blood outlet 56 are connected to the respective oxygenation units 100 through the blood flow path 59. The gas inlet 53 is connected to an air-oxygen mixer, which is a mixer that provides a certain ratio of air and oxygen. The direction of the blood flow channel 59 between the blood inlet 55 and the blood outlet 56 is perpendicular to the direction of the gas passage between the gas inlet 53 and the gas outlet 54. Preferably, the gas inlet 53 and the gas outlet 54 are provided on the left and right side surfaces of the oxygenator housing 51, respectively, and the blood inlet 55 and the blood outlet 56 are provided on the top and bottom surfaces of the oxygenator housing 51, respectively.

The gas chamber 52 may be transparent, wherein the pressure therein may be adjusted, and a pressure sensor 58 may be provided inside the gas chamber 52 to sense and display the pressure of the gas chamber 52.

The exterior of the gas chamber 52 of the oxygenator is provided with temperature control means 57 for maintaining the blood flowing through the oxygenator at a certain temperature. Preferably, a sensing unit such as a blood oxygen saturation sensor, a pressure sensor, a flow sensor, a temperature sensor, and a bubble sensor may be further installed at the temperature control device 57.

As shown in fig. 16, the two ends of the oxygenation unit 100 are connected with sensing modules 40, and the sensing modules 40 may be integrated with various sensors such as pressure sensor, temperature sensor, flow sensor, bubble sensor, and blood oxygen saturation sensor, and are used for monitoring parameters such as blood pressure, temperature, flow, bubbles, venous blood oxygen saturation, hematocrit, and hemoglobin.

The oxygenator has small precharge amount, small pressure drop and convenient use, the oxygenation membrane adopts the polydimethylsiloxane material with good air permeability, the gas exchange of blood is convenient, an ultrathin blood passage is formed between the two layers of oxygenation membranes, the thickness of the blood passage can be accurately adjusted, and the efficient gas exchange effect is further realized. The oxygenator of the present invention has a structure more similar to that of a physiological alveolus, and the ultrathin blood passage in the oxygenation part is similar to the capillary vessel network of the alveolus. The air pressure in the air cavity is adjustable, and the expansion and contraction effects of the whole air path system and the alveolus are closer by combining the adjustable pressure plate spacing. These features allow the oxygenator of the present invention to have a large specific surface area, a small resistance and pressure drop, a high gas exchange efficiency, and a small priming volume. The use of an anticoagulant coating also allows for good biocompatibility of the present oxygenator.

Although the present invention has been described in detail with reference to the foregoing embodiments, it should be understood by those skilled in the art that the following descriptions are only illustrative and not restrictive, and that the scope of the present invention is not limited to the above embodiments: any person skilled in the art can modify or improve the technical solutions described in the foregoing embodiments or make equivalent substitutions for some technical features within the technical scope of the present disclosure; such modifications, changes or substitutions do not depart from the spirit and scope of the embodiments of the present invention, and they should be construed as being included therein. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims (10)

1. An oxygenator, characterized in that it comprises at least one oxygenation unit (100), said oxygenation unit (100) comprising an inflow portion (10), an oxygenation portion (20) and an outflow portion (30), wherein,

the oxygenation part (20) comprises two layers of oxygenation membranes (21) which are stacked, and a blood flow channel is formed in a region between the inner sides of the two layers of oxygenation membranes (21).

2. The oxygenator according to claim 1, wherein an oxygenating portion housing (23) is provided outside two layers of the oxygenating membrane (21), a window (24) is provided on the oxygenating portion housing (23) to expose the oxygenating membrane (21), and a pressing plate (25) is provided on each of both outer sides of the oxygenating portion (20), the pressing plate (25) being provided on the outer side of the oxygenating membrane (21) exposed through the window (24).

3. The oxygenator according to claim 1, wherein the oxygenating part (20) further includes a support part (22) disposed in a blood flow channel between inner sides of the two layers of the oxygenation membranes (21), and the support part (22) is a woven mesh structure or a boss structure (211) formed by micro nano processing.

4. The oxygenator of claim 2, wherein the pressure plate (25) is woven or laser engraved, the pressure plate (25) having a mesh or openwork structure.

5. The oxygenator according to claim 2, further comprising a platen gap adjusting device (26) provided on an edge of the platen (25) to adjust a spacing between the two platens (25), the platen gap adjusting device (26) comprising a ram (261) and a ram control device (262).

6. The oxygenator of claim 1, wherein the inflow portion (10) is of the same construction as the outflow portion (30), the inflow portion (10) including a round bore end (101) and a flattened end (102), the flattened end (102) having a cross-sectional flow area greater than or equal to the cross-sectional flow area of the round bore end (101).

7. The oxygenator of claim 1, wherein the inflow portion (10) has an inflow portion baffle (12) therein and the outflow portion (30) has an outflow portion baffle (32) therein.

8. The oxygenator of claim 1, wherein the oxygenation membrane (21) is of polydimethylsiloxane material.

9. The oxygenator of claim 1, further comprising an oxygenator housing (51), a gas chamber (52) enclosed by the oxygenator housing (51), a gas inlet (53) and a gas outlet (54) disposed on left and right sides of the oxygenator housing (51), a blood inlet (55) and a blood outlet (56) disposed on top and bottom sides of the oxygenator housing (51), wherein the at least one oxygenation unit (100) is located within the gas chamber (52), the blood inlet (55) and the blood outlet (56) are connected to the at least one oxygenation unit (100) by a blood flow channel (59), and the gas inlet (53) is connected to an air-oxygen mixer.

10. The oxygenator of claim 1, characterized in that a temperature control device (57) is connected to the oxygenator and a sensing module (40) is connected to both ends of the oxygenation unit (100), the sensing module (40) integrating a pressure sensor, a temperature sensor, a flow sensor, a bubble sensor and a blood oxygen saturation sensor.

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