oxygenator

Abstract

The present application relates to the technical field of medical devices, and particularly discloses an oxygenator. The oxygenator has a blood inlet on the upper part of the shell, a blood outlet on the lower part of the shell, and a heating module and the inner side wall of the shell form an outflow channel. Blood enters the outflow channel after passing through the oxygenation module and the heating module in sequence through the blood inlet, and then is discharged through the blood outlet. The blood flow rate at both ends of the heating module is relatively low, and at least one end of the heating module is in contact with the inner side wall of the shell in the circumferential direction, so that the thrombus formed in the low-speed area adheres to the heating module, and the thrombus cannot flow into the human body with the blood.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to an oxygenator. Background Technology

[0002] The oxygenator is one of the core components of extracorporeal membrane oxygenation (ECMO), responsible for enabling lung function and facilitating the exchange of carbon dioxide and oxygen in the blood. Taking a common membrane oxygenator as an example, blood is drawn from the patient and enters the oxygenator through the blood inlet, while fresh oxygen enters the hollow oxygenation fiber bundles through the gas inlet. Gas and blood are on opposite sides of the oxygenation membrane fibers, and the carbon dioxide in the blood and the oxygen in the membrane fibers are exchanged through a pressure difference, thus achieving gas exchange.

[0003] Existing oxygenators have an external flow channel around the heating membrane wire. This channel collects blood, which then flows out through the blood outlet. In this technology, the blood entering the oxygenator has a large circumferential diffusion area. The upper and lower ends of the external flow channel near the blood outlet, as well as the side opposite the blood outlet, are prone to forming low-velocity areas of blood flow. Blood clots are easily formed in these low-velocity areas, posing a risk of these clots entering the body via the bloodstream. Summary of the Invention

[0004] The purpose of this invention is to provide an oxygenator that reduces the risk of blood clots formed in the low-speed region of the external flow channel entering the human body with the blood.

[0005] To achieve this objective, the present invention adopts the following technical solution:

[0006] Oxygenator, including:

[0007] The outer casing has a blood inlet at its upper part and a blood outlet at its lower part.

[0008] The oxygenation module is disposed within the outer casing;

[0009] A heating module is disposed on the outside of the oxygenation module, and the gap between the heating module and the inner wall of the outer shell forms an external flow channel. The blood inlet allows blood to flow in and pass through the oxygenation module and the heating module in sequence into the external flow channel. At least one end of the heating module is circumferentially abutted against the inner wall of the outer shell.

[0010] As an optional technical solution for the oxygenator described above, the blood inlet is located at the top center of the outer shell, the blood outlet is located on the side wall of the outer shell, and both ends of the heating module abut against the inner side wall of the outer shell in the circumferential direction.

[0011] As an alternative technical solution for the aforementioned oxygenator, the middle part of the outer surface of the heating module is recessed in the circumferential direction, and the surface formed by the recess of the heating module is an arc-shaped surface.

[0012] As an optional technical solution for the aforementioned oxygenator, the height of the outer flow channel is 40mm-45mm, and the maximum width of the outer flow channel is 1.5mm-2mm.

[0013] As an optional technical solution for the oxygenator described above, the sidewalls at both ends of the heating module are flat surfaces that fit against the inner sidewall of the outer shell, and the flat surfaces smoothly transition to the middle of the heating module.

[0014] As an optional technical solution for the oxygenator described above, the ratio of the sum of the heights of the two planes to the height of the outer flow channel is 0.22-0.25.

[0015] As an alternative technical solution for the aforementioned oxygenator, the external flow channel is eccentrically positioned relative to the blood inlet, and at the same height, the width of the external flow channel near the blood outlet is greater than the width of the flow channel away from the blood outlet.

[0016] As an optional technical solution for the aforementioned oxygenator, an isolation component is provided between the end of the heating module that is attached to the inner wall of the outer shell and the oxygenation module.

[0017] As an alternative technical solution for the aforementioned oxygenator, the width of the isolation member gradually decreases towards the center of the heating module, and the size of the isolation member fitting with the heating module is larger than the size of the heating module fitting with the inner wall of the outer shell.

[0018] As an alternative technical solution for the oxygenator described above, the heating module includes a heating membrane wire, which is wound around the outside of the oxygenation module, and at least one end of the outermost heating membrane wire abuts against the inner sidewall of the outer shell.

[0019] The beneficial effects of this invention are:

[0020] The oxygenator provided by this invention has a blood inlet at the upper part of the outer shell and a blood outlet at the lower part of the outer shell. The gap between the heating module and the inner wall of the outer shell forms an external flow channel. Blood enters the external flow channel after passing through the oxygenation module and the heating module in sequence through the blood inlet, and then exits through the blood outlet. The blood flow velocity at both ends of the heating module is relatively low. At least one end of the heating module abuts against the inner wall of the outer shell in the circumferential direction, so that the thrombus formed by the blood in the low-velocity area adheres to the heating module and the thrombus will not enter the human body with the blood flow. Attached Figure Description

[0021] Figure 1This is a schematic diagram of the oxygenator provided in an embodiment of the present invention;

[0022] Figure 2 This is a schematic diagram of the internal structure of the oxygenator provided in an embodiment of the present invention;

[0023] Figure 3 This is a cross-sectional view of the internal structure of the oxygenator provided in an embodiment of the present invention;

[0024] Figure 4 This is a graph showing the changing trend of dead zone volume and pressure drop corresponding to the maximum width of the flow channel in an embodiment of the present invention;

[0025] Figure 5 This is a graph showing the trend of dead zone coverage in an embodiment of the present invention.

[0026] In the picture:

[0027] 1. Outer shell; 2. Blood inlet; 3. Blood outlet; 4. Heating module; 5. Outer flow channel; 6. Blood outlet pipe; 7. Blood inlet pipe; 8. Oxygenation module; 9. Blood flow channel; 10. Exhaust port; 11. Isolation component. Detailed Implementation

[0028] To make the technical problems solved by the present invention, the technical solutions adopted, and the technical effects achieved clearer, the technical solutions of the embodiments of the present invention will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0029] In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0030] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0031] like Figures 1 to 3 As shown, this embodiment provides an oxygenator, which includes a housing 1, an oxygenation module 8, and a heating module 4. Both the oxygenation module 8 and the heating module 4 are disposed within the housing 1, with the heating module 4 located outside the oxygenation module 8. The heating module 4 is spaced apart from the inner wall of the housing 1, forming an external flow channel 5. A blood inlet 2 is provided at the upper part of the housing 1, and a blood outlet 3 is provided at the lower side wall of the housing 1. Blood can enter the oxygenator through the blood inlet 2, flowing sequentially through the oxygenation module 8 and the heating module 4 into the external flow channel 5, and then exiting through the blood outlet 3. Blood undergoes oxygenation within the oxygenation module 8, and is heated within the heating module 4.

[0032] Alternatively, the blood inlet 2 is located at the top center of the housing 1, and the blood outlet 3 is located on the side wall of the housing 1, so that the blood can flow fully through the oxygenation module 8 and the heating module 4.

[0033] When blood flows into the oxygenator through the blood inlet 2, the blood flow rate is relatively low when it first enters the oxygenator. The blood flow rate decreases as it flows to the bottom of the oxygenator. Therefore, in this embodiment, at least one end of the heating module 4 is circumferentially abutted against the inner wall of the outer shell 1 so that the blood clot formed in the low-speed area adheres to the heating module 4 and the blood clot will not enter the human body with the blood flow.

[0034] Optionally, both ends of the heating module 4 are circumferentially abutted against the inner wall of the outer shell 1. The areas where the blood flow velocity is relatively low when it first enters the oxygenator and the areas where the blood flow velocity is relatively low at the bottom of the oxygenator are both low-speed areas. In these two low-speed areas, the heating module 4 abuts against the inner wall of the outer shell 1 so that the blood clot formed in the low-speed area adheres to the heating module 4, reducing the probability of the blood clot entering the human body with the blood flow.

[0035] In some embodiments, the heating module 4 includes a heating membrane wire wound around the outside of the oxygenation module 8. After the heating membrane wire is wound around the outside of the oxygenation module 8, the heating membrane wire is pressed down to deform it, causing at least one end of the heating membrane wire to bend and abut against the inner wall of the outer casing 1. The gap between the remaining portion of the heating membrane wire and the inner wall of the outer casing 1 forms an external flow channel 5. Specifically, at least one end of the outermost heating membrane wire abuts against the inner wall of the outer casing 1, so that thrombi in the low-velocity region adhere to the heating membrane wire and do not fall off.

[0036] After the heating membrane is deformed by pressing down, the end of the heating module 4 that is attached to the inner wall of the outer shell 1 is separated from the oxygenation module 8. Therefore, an isolation member 11 is provided between the end of the heating module 4 that is attached to the inner wall of the outer shell 1 and the oxygenation module 8. The isolation member 11 can fill the gap between the heating module 4 and the oxygenation module 8, and prevent the blood in the oxygenation module 8 from not flowing through the heating module 4.

[0037] Optionally, the width of the isolation member 11 gradually decreases towards the middle of the heating module 4, and the bonding size between the isolation member 11 and the heating film block 4 is larger than the bonding size between the heating module 4 and the inner sidewall of the outer shell 1, so that the isolation member 11 can adapt to the deformation of the heating module 4 after bending, so as to fully fill the gap between the heating module 4 and the oxygenation module 8.

[0038] In some embodiments, the middle portion of the outer surface of the heating module 4 is recessed circumferentially, and the surface formed by the recess of the heating module 4 is an arc-shaped surface. An external flow channel 5 is formed between the arc-shaped surface and the inner sidewall of the outer casing 1, and the smooth outer surface of the heating module 4 will not damage the blood components.

[0039] The height of the outer flow channel 5 is 40mm-50mm, preferably 40mm-45mm. The maximum width of the outer flow channel 5 is 1.5mm-2mm. The height and width of the outer flow channel 5 determine the curvature of its bending. Specifically, the curvature of the outer flow channel 5 can be set according to actual usage requirements. The height range of the outer flow channel 5 is selected based on the pre-fill volume and specific application scenario. Based on the height of the outer flow channel 5, a suitable maximum width needs to be designed to ensure that the volume occupied by the flow velocity dead zone in the outer flow channel 5 is minimized and that sufficient pressure drop is ensured so that blood can flow smoothly. Figure 4 When the height of the outer flow channel 5 is selected as 42mm, the corresponding change in the volume (normalized) of the velocity dead zone in the outer flow channel 5 is as follows: the velocity dead zone is defined as the region where the flow velocity is below 0.5mm / s under operating conditions; and the pressure drop of the oxygenator (normalized) is as follows: Figure 4It can be seen that the volume of the dead zone in the outer channel 5 exhibits a significant variation trend before the maximum width of the outer channel 5 reaches 1.5 mm. After exceeding the maximum width of 1.5 mm, increasing the maximum width does not contribute to reducing the dead zone volume, and further increasing the maximum width will increase the pre-charge. The pressure drop decreases with increasing maximum width, and a lower pressure drop is more beneficial to the oxygenator's fluid performance. However, after the maximum width reaches 2 mm, the trend of pressure drop variation slows down, and further increasing the maximum width will increase the pre-charge, producing other negative effects. In summary, considering the changes in pressure drop, velocity dead zone, and pre-charge, when the height of the outer channel 5 is between 40 mm and 45 mm, a maximum width of 1.5 mm to 2 mm is the preferred option in this application, offering significant advantages compared to other size choices.

[0040] Alternatively, the sidewalls at both ends of the heating module 4 are flat surfaces that fit against the inner sidewall of the outer casing 1 to ensure that the thrombus in the heating module 4 does not dislodge. The flat surfaces smoothly transition to the middle of the heating module 4 to avoid damaging the blood components.

[0041] The ratio of the sum of the heights of the two planes to the height of the outer flow channel 5 is 0.22-0.25. This ensures that blood can flow in and out of the oxygenator within a specified flow rate range, while maintaining the adhesion of thrombi formed in the low-velocity region to the heating module 4. Selecting a ratio of 0.22-0.25 for the sum of the heights of the two planes to the height of the outer flow channel 5 ensures that the wall-attached area of ​​the heating module 4 can cover most of the flow rate dead zones, i.e., areas with flow rates below 0.5 mm / s. Figure 5 The diagram shows the dead zone coverage rate trend of an embodiment of the present invention, corresponding to different ratios of the sum of the heights of the two planes to the height of the outer channel 5, representing the coverage rate of the velocity dead zone (volume of the region with a velocity below 0.5 mm / s). As can be seen from the design scheme, the larger the aforementioned ratio, the greater the coverage of the dead zone by the wall-mounted structure, but it will also correspondingly occupy space in the outer channel 5. According to the trend diagram, before the ratio reaches 0.22, increasing the proportion of the wall-mounted area will have a significant impact on the dead zone coverage rate. The coverage rate tends to level off in the 0.22 to 0.25 range, and there is basically no change after 0.25. Since a low-velocity region still exists at the Luer joint, it is impossible to achieve 100% coverage. Considering the volume of the outer channel, from... Figure 5 It can be seen that selecting a ratio of 0.22-0.25 between the sum of the heights of the two planes and the height of the outer channel 5 has outstanding substantial characteristics compared to other ranges.

[0042] The blood flow velocity is low in the outer flow channel 5 located away from the blood outlet 3. In some embodiments, the outer flow channel 5 is eccentrically positioned relative to the blood inlet 2, and at the same height, the width of the outer flow channel 5 near the blood outlet 3 is greater than the width of the flow channel away from the blood outlet 3. By reducing the width of the flow channel away from the blood outlet 3, the blood velocity in the flow channel away from the blood outlet 3 can be increased under the same blood flow rate, reducing the probability of blood clot formation.

[0043] In some embodiments, the outer casing 1 has a cylindrical structure, and a blood outlet pipe 6 is connected to the blood outlet 3. The axis of the blood outlet pipe 6 is set at an angle to the axis of the blood outlet 3 to prevent blood clots from forming at the connection between the blood outlet pipe 6 and the blood outlet 3. The wall of the blood outlet pipe 6 is smoothly connected to the outer casing 1 to avoid damaging the blood components.

[0044] A blood inlet pipe 7 is connected to the blood inlet 2, and the blood inlet pipe 7 is eccentrically positioned relative to the blood inlet 2. After the blood enters the oxygenator, it rotates in the blood flow channel 9, and under the action of centrifugal force, the air bubbles in the blood are discharged from the exhaust port 10.

[0045] In the prior art, the oxygenator has low-speed blood flow areas at both ends of the outer flow channel 5. In this embodiment, at least one end of the heating module 4 is abutted against the inner wall of the outer shell 1. The thrombus formed in the low-speed area adheres to the heating module 4, which neither affects the oxygenation performance of the oxygenator nor prevents the thrombus formed in the low-speed area of ​​the outer flow channel 5 from entering the human body with the blood.

[0046] The side of the outflow channel 5 away from the blood outlet 3 is a low-speed area for blood flow. In this embodiment, the outflow channel 5 is set off-center relative to the blood inlet 2. By reducing the width of the flow channel away from the blood outlet 3, the speed of blood in the flow channel away from the blood outlet 3 can be increased under the same blood flow rate, thereby reducing the probability of blood clot formation.

[0047] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. An oxygenator, characterized in that, include: The outer shell (1) has a blood inlet (2) at its upper part and a blood outlet (3) at its lower part; An oxygenation module (8) is disposed inside the outer casing (1); The heating module (4) is disposed on the outside of the oxygenation module (8), and the gap between it and the inner wall of the outer shell (1) forms an external flow channel (5). The blood inlet (2) allows blood to flow in and pass through the oxygenation module (8) and the heating module (4) in sequence into the external flow channel (5). At least one end of the heating module (4) is circumferentially abutted against the inner wall of the outer shell (1). Both ends of the heating module (4) are circumferentially abutted against the inner sidewall of the outer shell (1); The heating module (4) has a concave outer surface in the middle along the circumference, and the concave surface formed by the heating module (4) is an arc-shaped surface.

2. The oxygenator according to claim 1, characterized in that, The blood inlet (2) is located at the top center of the outer shell (1), and the blood outlet (3) is located on the side wall of the outer shell (1).

3. The oxygenator according to claim 1, characterized in that, The height of the outer flow channel (5) is 40mm-45mm, and the maximum width of the outer flow channel (5) is 1.5mm-2mm.

4. The oxygenator according to claim 1, characterized in that, The sidewalls at both ends of the heating module (4) are planes that fit against the inner sidewall of the outer shell (1), and the planes smoothly transition to the middle of the heating module (4).

5. The oxygenator according to claim 4, characterized in that, The ratio of the sum of the heights of the two planes to the height of the outer channel (5) is 0.22-0.

25.

6. The oxygenator according to claim 2, characterized in that, The external flow channel (5) is eccentrically positioned relative to the blood inlet (2), and at the same height, the width of the external flow channel (5) near the blood outlet (3) is greater than the width of the flow channel away from the blood outlet (3).

7. The oxygenator according to claim 1, characterized in that, An isolation element (11) is provided between the end of the heating module (4) that is attached to the inner wall of the outer shell (1) and the oxygenation module (8).

8. The oxygenator according to claim 7, characterized in that, The isolation member (11) gradually decreases in size towards the center of the heating module (4), and the size of the isolation member (11) that fits with the heating module (4) is larger than the size of the heating module (4) that fits with the inner wall of the outer shell (1).

9. The oxygenator according to claim 1, characterized in that, The heating module (4) includes a heating membrane filament, which is wound around the outside of the oxygenation module (8), and at least one end of the outermost heating membrane filament abuts against the inner wall of the outer shell (1).

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