Gas exchange device

Abstract

A gas exchange device, comprising a housing, a gas exchange module (3), and a heat exchange cylinder (4). The housing comprises a substantially cylindrical outer shell (1) and end caps located at both ends of the outer shell (1). The heat exchange cylinder (4) is arranged between the outer shell (1) and the gas exchange module (3), and a heat exchange medium chamber (41) is formed between the heat exchange cylinder (4) and the outer shell (1). A heat exchange medium can flow from a heat exchange medium inlet (13) into the heat exchange medium chamber (41). The heat exchange medium chamber (41) is not in fluid communication with the blood. The heat exchange medium in the heat exchange medium chamber (41) can exchange heat with the blood in the gas exchange module (3).

Description

Gas exchange device

[0001] This application claims priority to Chinese Patent Application No. 202410683204.3, filed with the Chinese Patent Office on May 29, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0002] This application relates to the field of medical device technology, such as a gas exchange device. Background Technology

[0003] The main functions of the lungs are blood oxygenation and removal of carbon dioxide from the blood. Gas exchange devices that partially or completely replace the main functions of the lungs include extracorporeal membrane oxygenation (ECMO) and extracorporeal carbon dioxide removal (ECCO2R).

[0004] ECMO, for example, is a medical device that performs gas exchange outside the patient's body to oxygenate the blood, thereby partially or completely replacing the patient's cardiopulmonary function. It is often used in complex surgeries such as cardiac arrest, cardiopulmonary failure, or organ transplantation.

[0005] An oxygenator, a gas exchange device, is one of the core components of ECMO (Extracorporeal Membrane Oxygenation). It is used to restore lung function and facilitate the exchange of carbon dioxide and oxygen in the blood. Taking a common membrane oxygenator as an example, after the patient's blood is drawn, it enters the oxygenator through the blood inlet, while fresh oxygen enters the hollow oxygenation membrane fibers through the gas inlet. The gas and blood exchange fresh oxygen and carbon dioxide in the blood through diffusion on both sides of the oxygenation membrane fibers.

[0006] Currently, there are very few oxygenators designed specifically for infants and young children. Existing oxygenators suitable for infants and young children either lack heat exchange functionality or have excessively high pre-charge levels. Summary of the Invention

[0007] This application provides a gas exchange device that can perform heat exchange without increasing the blood pre-fill volume, and can achieve effective heating and heat preservation functions, making it suitable for use by infants or adults with low pre-fill volume requirements.

[0008] A gas exchange device, comprising:

[0009] The housing includes a generally cylindrical outer shell and end caps located at both ends of the outer shell. The housing is provided with a blood inlet, a blood outlet, a heat exchange medium inlet, and a heat exchange medium outlet.

[0010] A gas exchange module, disposed inside the housing, allows blood flowing in from the blood inlet to pass through the gas exchange module for gas exchange before flowing out from the blood outlet; and

[0011] A heat exchange cylinder is disposed between the outer shell and the gas exchange module, and is arranged around the gas exchange module. A heat exchange medium chamber is formed between the heat exchange cylinder and the outer shell. The heat exchange medium can flow into the heat exchange medium chamber from the heat exchange medium inlet and flow out from the heat exchange medium outlet.

[0012] The heat exchange medium chamber is not fluidly connected to the blood, and the heat exchange medium can exchange heat with the blood flowing through the gas exchange module via the heat exchange cylinder.

[0013] As an optional technical solution for the aforementioned gas exchange device, the heat exchange cylinder is made of metal.

[0014] As an optional technical solution for the aforementioned gas exchange device, the heat exchange cylinder is configured to fit closely to the gas exchange module.

[0015] As an optional technical solution for the aforementioned gas exchange device, the gas exchange module includes a gas exchange zone and sealing zones located at both ends of the gas exchange zone. The outer peripheral surface of the gas exchange zone includes a covered area covered by the heat exchange cylinder and an uncovered area not covered by the heat exchange cylinder. The outer shell is at least partially made of transparent or semi-transparent material, so that the outer shell forms at least one observation window at the position corresponding to the uncovered area.

[0016] As an optional technical solution for the aforementioned gas exchange device, the uncovered area is located at at least one of the upper or lower ends of the outer peripheral surface of the gas exchange area.

[0017] As an optional technical solution for the aforementioned gas exchange device, the uncovered area is arranged 360° around the gas exchange area.

[0018] As an optional technical solution for the aforementioned gas exchange device, the axial height of the uncovered area located at the upper end of the outer peripheral surface of the gas exchange zone is 3mm-15mm; and / or

[0019] The axial height of the uncovered area located at the lower end of the outer peripheral surface of the gas exchange zone is 3mm-15mm.

[0020] As an optional technical solution for the aforementioned gas exchange device, the upper and lower ends of the outer peripheral surface of the gas exchange zone are respectively provided with uncovered areas, wherein the height of the uncovered area at the lower end is greater than the height of the uncovered area at the upper end.

[0021] As an optional technical solution for the aforementioned gas exchange device, the uncovered area is located on at least one of the outer peripheral surface of the gas exchange area facing the blood outlet or away from the blood outlet.

[0022] As an optional technical solution for the aforementioned gas exchange device, the uncovered area is arranged around the gas exchange area at an angle of 5°-90°. Attached Figure Description

[0023] Figure 1 is a schematic diagram of the gas exchange device provided in an embodiment of this application;

[0024] Figure 2 is a cross-sectional view of the gas exchange device provided in an embodiment of this application;

[0025] Figure 3 is a schematic diagram of the heat exchange medium flow direction provided in an embodiment of this application;

[0026] Figure 4 is a structural schematic diagram of the first housing and partition plate provided in an embodiment of this application;

[0027] Figure 5 is a schematic diagram of the structure of the partition plate and heat exchange cylinder provided in the embodiment of this application;

[0028] Figure 6 is a first-view structural schematic diagram of the bottom heat exchange channel provided in an embodiment of this application;

[0029] Figure 7 is a structural schematic diagram of the bottom heat exchange channel provided in an embodiment of this application from a second perspective.

[0030] Figure 8 is a schematic diagram of blood flow provided in an embodiment of this application.

[0031] In the diagram: 1. Outer shell; 2. Blood flow channel; 3. Gas exchange module; 4. Heat exchange cylinder; 5. Observation window; 6. Internal heat exchange module; 7. Bottom heat exchange channel; 8. Blood inflow channel; 9. Top end cap; 11. Blood inlet; 12. Blood outlet; 13. Heat exchange medium inlet; 14. Heat exchange medium outlet; 15. Base; 16. First outer shell; 17. Second outer shell; 31. Gas exchange area; 32. Sealing area; 41. Heat exchange medium chamber; 411. First heat exchange medium chamber; 412. Second heat exchange medium chamber; 42. Partition plate; 71. First bottom heat exchange channel; 72. Second bottom heat exchange channel. Detailed Implementation

[0032] In the description of this application, unless otherwise expressly 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 application based on the specific circumstances.

[0033] In this application, unless otherwise expressly 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 being 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 being 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.

[0034] As shown in Figures 1 and 2, this embodiment provides a gas exchange device, which can be an oxygenation device for blood oxygenation, a carbon dioxide removal device for removing carbon dioxide from blood, or a gas exchange device for other therapeutic purposes of blood. This application does not limit the scope of the application.

[0035] The gas exchange device includes a housing, a gas exchange module 3, and a heat exchange cylinder 4. The housing includes a generally cylindrical outer shell 1 and end caps located at both ends of the outer shell 1. The housing is provided with a blood inlet 11, a blood outlet 12, a heat exchange medium inlet 13, and a heat exchange medium outlet 14. The gas exchange module 3 is disposed inside the outer shell 1. Blood flows into the blood inlet 11, and the blood exchanges gases with the gas exchange module 3 as it flows through it, and then flows out from the blood outlet 12.

[0036] In some embodiments, the gas exchange module 3 includes a plurality of hollow fiber membranes, in which gas flows inside the hollow fiber membranes and blood flows between the hollow fiber membranes. Gas and blood exchange occurs between the two sides of the hollow fiber membranes through diffusion.

[0037] In some embodiments, the gas is oxygen or a mixture containing oxygen; in other embodiments, the gas is carbon dioxide or a mixture containing carbon dioxide.

[0038] A heat exchange cylinder 4 is disposed between the outer shell 1 and the gas exchange module 3, and is arranged around the gas exchange module 3. A heat exchange medium chamber 41 is formed between the heat exchange cylinder 4 and the outer shell 1. The heat exchange medium can flow into the heat exchange medium chamber 41 from the heat exchange medium inlet 13 and flow out from the heat exchange medium outlet 14. The heat exchange medium chamber 41 is not fluidly connected to the blood. The heat exchange medium can exchange heat with the blood flowing through the gas exchange module 3 through the heat exchange cylinder 4.

[0039] The gas exchange device provided in this embodiment has a heat exchange cylinder 4 between the outer shell 1 and the gas exchange module 3, and a heat exchange medium chamber 41 is formed between the heat exchange cylinder 4 and the outer shell 1. The heat exchange medium can flow into the heat exchange medium chamber 41 from the heat exchange medium inlet 13. The heat exchange medium chamber 41 is not fluidly connected to the blood. The heat exchange medium in the heat exchange medium chamber 41 can exchange heat with the blood in the gas exchange module 3. Under the premise of achieving effective heat exchange function, the blood pre-filling volume of the gas exchange device is not increased, which is suitable for use by infants or adults with low pre-filling volume requirements.

[0040] In some embodiments, the heat exchange cylinder 4 is made of metal, which has high heat transfer efficiency and can improve the heat exchange efficiency between the heat exchange medium and the blood in the gas exchange module 3. Optionally, the heat exchange cylinder 4 is made of stainless steel.

[0041] In some embodiments, the heat exchange cylinder 4 is fitted to the gas exchange module 3, and the heat exchange medium flows within the heat exchange medium chamber 41. The heat exchange medium transfers heat to the blood within the gas exchange module 3 through the side wall of the heat exchange cylinder 4. The fitted arrangement of the heat exchange cylinder 4 to the gas exchange module 3 improves the heat exchange efficiency between the heat exchange medium and the blood within the gas exchange module 3. The gas exchange module 3 has a cylindrical structure, and the heat exchange cylinder 4 is sleeved on the outside of the gas exchange module 3. In other feasible embodiments, there is a certain radial gap between the heat exchange cylinder 4 and the gas exchange module 3.

[0042] The gas exchange module 3 includes a gas exchange zone 31, with sealing zones 32 at both ends of the gas exchange zone 31. A heat exchange cylinder 4 is disposed on the outer peripheral surface of the gas exchange zone 31. The gas exchange zone 31 is configured to exchange gases with blood, and the sealing zones 32 are configured to seal both ends of the gas exchange zone 31 to prevent blood leakage.

[0043] In some embodiments, as shown in Figures 3, 4, and 5, one end of the outer casing 1 is provided with a heat exchange medium inlet 13 and a heat exchange medium outlet 14, with the heat exchange medium inlet 13 located below the heat exchange medium outlet 14. The heat exchange medium inlet 13 and the heat exchange medium outlet 14 can be located on the same side of the casing. The heat exchange medium chamber 41 has an annular structure, including a first heat exchange medium chamber 411 and a second heat exchange medium chamber 412. One end of the first heat exchange medium chamber 411 is connected to the heat exchange medium inlet 13, and the other end of the first heat exchange medium chamber 411 is connected to one end of the second heat exchange medium chamber 412. The other end of the second heat exchange medium chamber 412 is connected to the heat exchange medium outlet 14. The heat exchange medium enters the first heat exchange medium chamber 411 through the heat exchange medium inlet 13, then flows into the second heat exchange medium chamber 412, and is discharged through the heat exchange medium outlet 14 to form a cycle, thereby achieving heat exchange with the blood in the gas exchange module 3.

[0044] Optionally, the outer casing 1 includes a base 15, a first outer casing 16, and a second outer casing 17 connected in sequence. A heat exchange medium inlet 13 is disposed on the base 15, a heat exchange medium outlet 14 is disposed on the second outer casing 17, a heat exchange cylinder 4 is disposed inside the second outer casing 17, and a gas exchange module 3 is disposed inside the first outer casing 16 and the second outer casing 17. One end of the base 15 is connected to one end of the first outer casing 16 by a plug-in connection, and the end of the first outer casing 16 away from the base 15 is connected to one end of the second outer casing 17 by a plug-in connection. Two partition plates 42 are spaced apart at the end of the first outer casing 16 connected to the second outer casing 17. The partition plates 42 extend into the heat exchange medium chamber 41 between the second outer casing 17 and the heat exchange cylinder 4, dividing the heat exchange medium chamber 41 into a first heat exchange medium chamber 411 and a second heat exchange medium chamber 412.

[0045] The end caps located at both ends of the outer casing 1 are a top end cap 9 and a bottom end cap (not shown in the figure). The top end cap 9 is connected to the end of the second outer casing 17 away from the first outer casing 16 by means of a plug-in connection, thereby sealing one end of the outer casing 1 and covering the outside of the sealing area 32 of the gas exchange module 3. The bottom end cap is located at the end of the base 15 away from the first outer casing 16 and is plugged into the base 15 to seal the other end of the outer casing 1.

[0046] Optionally, as shown in Figures 3, 6, and 7, the base 15 is further provided with a bottom heat exchange channel 7, which includes a first bottom heat exchange channel 71 and a second bottom heat exchange channel 72. One end of the first bottom heat exchange channel 71 is connected to the heat exchange medium inlet 13. An inner heat exchange module 6 is provided inside the gas exchange module 3. One end of the inner heat exchange module 6 is connected to the other end of the first bottom heat exchange medium channel 71, and the other end of the inner heat exchange module 6 is connected to one end of the second bottom heat exchange channel 72. The other end of the second bottom heat exchange channel 72 is connected to the first heat exchange medium chamber 411. The heat exchange medium enters the first bottom heat exchange channel 71 through the heat exchange medium inlet 13, and then flows upward into a portion of the space of the inner heat exchange module 6. When the water reaches the top of the inner heat exchange module 6, it crosses the partition plate 42 and enters another portion of the space of the inner heat exchange module 6, flowing from top to bottom. It then flows through the second bottom heat exchange channel 72 to the first heat exchange medium chamber 411 and the second heat exchange medium chamber 412, and is discharged through the heat exchange medium outlet 14. The inner heat exchange module 6 can exchange heat with the blood in the gas exchange module 3, further improving the efficiency of blood heat exchange and enhancing the heat preservation effect.

[0047] Optionally, as shown in Figures 2-3 and 7-8, the inner heat exchange module 6 has a double-layer cylindrical structure. A blood flow channel 2 is provided on the radially inner side of the inner layer of the inner heat exchange module 6. One end of the blood flow channel 2 is connected to the blood inlet 11, and the other end is connected to the upper end of the gas exchange area 31 of the gas exchange module 3. The blood inlet 11 and the blood outlet 12 are located at one end of the outer shell 1. The blood outlet 12 is correspondingly located at the lower end of the gas exchange area 31 of the gas exchange module 3, and the axial direction of the blood inlet 11 is perpendicular to the axial direction of the blood flow channel 2. Blood enters the blood flow channel 2 through the blood inlet 11, then enters the gas exchange module 3, and flows from the upper end to the lower end of the gas exchange module 3. After gas exchange within the gas exchange module 3, the blood flows out through the blood outlet 12. During the flow of blood in the blood flow channel 2 towards the upper end of the gas exchange area 31, heat exchange occurs with the inner heat exchange module 6, improving the efficiency of heat exchange and thus enhancing the heat preservation effect.

[0048] The blood inlet 11 and the blood outlet 12 are located on the same side of the outer casing 1. Optionally, the blood inlet 11 is located on the base 15, and the blood outlet 12 is located on the first outer casing 16. The base 15 has a blood inflow channel 8 inside. The first end of the blood inflow channel 8 is connected to the blood inlet 11, and the second end of the blood inflow channel 8, opposite to the first end, is connected to the first end of the blood flow channel 2. Optionally, the blood inflow channel 8 and the blood flow channel 2 are eccentrically arranged and approximately tangent to each other, so that when the blood enters the blood flow channel 2, it rotates within the blood flow channel 2, thereby avoiding blood damage caused by blood impact.

[0049] The gas exchange module 3 is prone to the formation of blood clots or bubbles. Medical personnel need to be aware of the formation of these clots or bubbles inside the gas exchange module 3 in order to take timely and appropriate measures. However, to improve heat exchange efficiency, the heat exchange cylinder 4 is made of metal. Therefore, in some embodiments, referring to Figures 2, 3, and 8, to facilitate observation of the internal conditions of the gas exchange device, the heat exchange cylinder 4 is configured to cover only a portion of the outer periphery of the gas exchange area 31. That is, the outer periphery of the gas exchange area 31 includes a covered area covered by the heat exchange cylinder 4 and an uncovered area not covered by the heat exchange cylinder 4. At the same time, the outer shell 1 is at least partially transparent or semi-transparent, so that at least one observation window 5 is formed in the outer shell 1 corresponding to the uncovered area. The observation window 5 allows medical personnel to observe the blood flow and the formation of bubbles or clots inside the gas exchange module 3 through the transparent or semi-transparent outer shell 1, and to replace the gas exchange device in a timely manner when necessary, thereby improving product safety.

[0050] In some embodiments, since the blood flow rate is slow in the upper and lower regions of the gas exchange zone 31, thrombi are more likely to form. At the same time, due to buoyancy, air bubbles are more likely to concentrate in the upper region of the gas exchange zone 31. Therefore, in order to understand the blood flow and air bubble or thrombus formation inside the gas exchange device in a timely manner while ensuring heat exchange efficiency, the uncovered area is located at the upper and / or lower end of the outer peripheral surface of the gas exchange zone 31, so that the observation window 5 can be set at the upper and / or lower end of the outer peripheral surface of the gas exchange zone 31.

[0051] Optionally, the uncovered area is set around the gas exchange area 31 at 360°, so that the observation window 5 can be set around the outer periphery of the gas exchange area 31 at 360°. This facilitates the processing and assembly of the heat exchange cylinder 4, and the internal situation of the gas exchange module 3 can be observed from every angle around the gas exchange device, improving the convenience of observation.

[0052] Optionally, to balance ease of observation and efficiency of blood heat exchange, the axial height of each uncovered area is set to 3mm-15mm. For example, the height of the uncovered area can be set to 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, or 15mm, without specific limitation. Optionally, the axial height of the uncovered area located at the upper end of the outer peripheral surface of the gas exchange area is 3mm-15mm; and / or the axial height of the uncovered area located at the lower end of the outer peripheral surface of the gas exchange area is 3mm-15mm.

[0053] Optionally, if the upper and lower regions of the outer periphery of the gas exchange zone 31 are respectively provided with uncovered areas, since the area at the lower end of the gas exchange zone 31 that is prone to thrombosis is larger than that at the upper end, the height of the uncovered area at the lower end is made greater than the height of the uncovered area at the upper end, so as to achieve accurate and comprehensive observation of the blood condition in the gas exchange device.

[0054] Optionally, the uncovered area can be arranged in a circumferentially discontinuous manner. For example, the uncovered area is located on the outer peripheral surface of the gas exchange zone 31 facing the blood outlet 12 and / or away from the blood outlet 12. At the locations facing and away from the blood outlet 12, the blood experiences a higher shear rate, making it more susceptible to damage and increasing the likelihood of thrombus formation. Therefore, observation windows 5 are provided at these locations to allow for timely observation of the internal condition of the gas exchange device. Optionally, the uncovered area is arranged at an angle of 5°-90° around the gas exchange zone, ensuring efficient blood heat exchange while facilitating observation of the internal blood condition.

[0055] In other embodiments, various arrangements of the uncovered area can be combined to achieve the best overall effect that facilitates observation and ensures heat exchange efficiency.

Claims

1. A gas exchange device, comprising: The housing includes a generally cylindrical outer shell (1) and end caps located at both ends of the outer shell (1). The housing is provided with a blood inlet (11), a blood outlet (12), a heat exchange medium inlet (13), and a heat exchange medium outlet (14). A gas exchange module (3) is disposed inside the outer casing (1). Blood flowing in from the blood inlet (11) can flow through the gas exchange module (3) to exchange gases with the gas exchange module (3), and then flow out from the blood outlet (12); and A heat exchange cylinder (4) is disposed between the outer shell (1) and the gas exchange module (3) and is arranged around the gas exchange module (3). A heat exchange medium chamber (41) is formed between the heat exchange cylinder (4) and the outer shell (1). The heat exchange medium can flow into the heat exchange medium chamber (41) from the heat exchange medium inlet (13) and flow out from the heat exchange medium outlet (14). The heat exchange medium chamber (41) is not fluidly connected to the blood, and the heat exchange medium can exchange heat with the blood flowing through the gas exchange module (3) through the heat exchange cylinder (4).

2. The gas exchange device of claim 1, wherein, The heat exchange cylinder (4) is made of metal.

3. The gas exchange device according to claim 1 or 2, wherein, The heat exchange cylinder (4) is fitted into the gas exchange module (3).

4. The gas exchange device according to claim 2, wherein, The gas exchange module (3) includes a gas exchange area (31) and sealing areas (32) located at both ends of the gas exchange area (31). The outer peripheral surface of the gas exchange area (31) includes a covered area covered by the heat exchange cylinder (4) and an uncovered area not covered by the heat exchange cylinder (4). The outer shell (1) is at least partially made of transparent or semi-transparent material, so that the outer shell (1) forms at least one observation window (5) at the position corresponding to the uncovered area.

5. The gas exchange device according to claim 4, wherein, The uncovered area is located at least one of the upper or lower ends of the outer peripheral surface of the gas exchange area (31).

6. The gas exchange device according to claim 5, wherein, The uncovered area is arranged 360° around the gas exchange area (31).

7. The gas exchange device according to claim 5 or 6, wherein, The axial height of the uncovered area located at the upper end of the outer peripheral surface of the gas exchange zone (31) is 3mm-15mm; and / or The axial height of the uncovered area located at the lower end of the outer peripheral surface of the gas exchange zone (31) is 3mm-15mm.

8. The gas exchange device according to claim 5 or 6, wherein, The outer periphery of the gas exchange zone (31) is provided with uncovered areas at the upper and lower ends, respectively, wherein the height of the uncovered area at the lower end is greater than the height of the uncovered area at the upper end.

9. The gas exchange device according to claim 4 or 5, wherein, The uncovered area is located on at least one of the outer peripheral surface of the gas exchange area (31) facing the blood outlet (12) or away from the blood outlet (12).

10. The gas exchange device according to claim 9, wherein, The uncovered area is set around the gas exchange area (31) at a 5°-90° angle.

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