Oxygenators and Extracorporeal Membrane Oxygenation Equipment

Abstract

This invention relates to the field of medical device technology, specifically disclosing an oxygenator and an extracorporeal membrane oxygenation (ECMO) device. The oxygenator provided by this invention has a heat exchange module that can exchange heat with the blood in the blood flow channel and the blood in the oxygenation module, respectively. That is, the blood undergoes a first heat exchange with the heat exchange module within the blood flow channel, and after the blood flows into the oxygenation module, the blood in the oxygenation module exchanges heat with the heat exchange module again. The oxygenated blood then flows out through the blood outlet, achieving two heat exchanges with the blood, thereby maintaining the blood temperature. Furthermore, compared to existing technologies using heating elements such as heating wires, this oxygenator's structure does not increase the pre-filled blood volume, making it suitable for infants.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an oxygenator and extracorporeal membrane oxygenation (ECMO) device. Background Technology

[0002] ECMO (Extracorporeal Membrane Oxygenation) is a medical device that performs gas exchange outside the patient's body to create an artificial heart and lungs, thereby replacing the patient's own heart and lung functions. It is often used in complex surgeries such as cardiac arrest, cardiopulmonary failure, or organ transplantation.

[0003] The oxygenator is one of the core components of ECMO (Extracorporeal Membrane Oxygenation), responsible for maintaining lung function and facilitating the exchange of carbon dioxide and oxygen in the blood. Taking a common membrane oxygenator as an example, after blood is drawn from the patient, it enters the oxygenator through the blood inlet, while fresh oxygen enters the hollow oxygenation fiber bundles through the gas inlet. Gas and blood exchange through diffusion across the oxygenation membrane fibers, facilitating the exchange of fresh oxygen and carbon dioxide from the blood.

[0004] Currently, there are very few oxygenators designed for infants, and existing oxygenators suitable for infants either lack heat exchange function or have excessive pre-fill volume. Summary of the Invention

[0005] The purpose of this invention is to provide an oxygenator and extracorporeal membrane oxygenation device, which can perform two heat exchanges without increasing the blood prefill volume, and is suitable for use in infants.

[0006] To achieve this objective, the present invention adopts the following technical solution:

[0007] On the one hand, an oxygenator is provided, comprising:

[0008] The outer casing has a blood inlet and a blood outlet.

[0009] A blood flow channel is provided inside the outer casing, through which blood flows into the blood flow channel from the blood inlet;

[0010] An oxygenation module is disposed inside the housing. The oxygenation module is connected to the blood flow channel and the blood outlet, and blood can flow along the blood flow channel through the oxygenation module to the blood outlet.

[0011] A heat exchange module is disposed inside the outer casing, and the heat exchange module can exchange heat with the blood in the blood flow channel and the blood in the oxygenation module respectively.

[0012] As an optional technical solution for the aforementioned oxygenator, the heat exchange module has a cylindrical structure, the blood flow channel is disposed in the inner cavity of the heat exchange module, and the oxygenation module is sleeved on the outer periphery of the heat exchange module.

[0013] As an optional technical solution for the oxygenator described above, the inner cavity of the heat exchange module is provided with a flow guide cone, and the blood flow channel is formed between the circumferential sidewall of the flow guide cone and the inner sidewall of the heat exchange module.

[0014] As an alternative technical solution for the aforementioned oxygenator, the oxygenation module includes an oxygenation membrane filament, which is wound around the outside of the heat exchange module.

[0015] As an optional technical solution for the aforementioned oxygenator, the outer shell is provided with a heat exchange medium inlet and a heat exchange medium outlet;

[0016] The heat exchange module includes an annular heat exchange chamber plate, which is a hollow plate forming a hollow heat exchange cavity inside. The heat exchange medium inlet and the heat exchange medium outlet are respectively connected to the heat exchange cavity. The blood flow channel is located on the inner side of the heat exchange chamber plate, and the oxygenation module is sleeved on the outer periphery of the heat exchange chamber plate.

[0017] As an optional technical solution for the oxygenator described above, the heat exchange module further includes a heat exchange medium flow channel disposed inside one end of the outer shell. The heat exchange medium flow channel is connected to the heat exchange cavity. The heat exchange medium inlet and the heat exchange medium outlet are both disposed at one end of the outer shell and are respectively connected to the heat exchange medium flow channel. The heat exchange medium flowing in through the heat exchange medium inlet can flow through the end of the heat exchange cavity away from the heat exchange medium flow channel and then flow out from the heat exchange medium outlet.

[0018] As an optional technical solution for the above-mentioned oxygenator, the heat exchange medium flow channel includes a first heat exchange medium flow channel and a second heat exchange medium flow channel, wherein the first heat exchange medium flow channel is connected to the heat exchange medium inlet and the second heat exchange medium flow channel is connected to the heat exchange medium outlet.

[0019] The heat exchange chamber includes a first heat exchange chamber and a second heat exchange chamber. One end of the first heat exchange chamber is connected to the first heat exchange medium channel, and the other end of the first heat exchange chamber is connected to one end of the second heat exchange chamber. The other end of the second heat exchange chamber is connected to the second heat exchange medium channel.

[0020] As an optional technical solution for the aforementioned oxygenator, the heat exchange medium flow channel has an annular structure, and two partition plates are provided inside the heat exchange medium flow channel. One end of each of the two partition plates is placed inside the heat exchange medium flow channel, dividing the heat exchange medium flow channel into a first heat exchange medium flow channel and a second heat exchange medium flow channel. The other ends of the two partition plates extend into the heat exchange cavity, dividing the heat exchange cavity into a first heat exchange cavity and a second heat exchange cavity.

[0021] As an alternative technical solution for the aforementioned oxygenator, the blood outlet is perpendicular to both the heat exchange medium inlet and the heat exchange medium outlet.

[0022] As an optional technical solution for the aforementioned oxygenator, the outer shell is provided with an oxygen outlet and an oxygen inlet, and the outer shell is provided with an oxygen channel. One end of the oxygen channel is connected to the oxygen inlet, and the other end of the oxygen channel is connected to the oxygen outlet. The oxygen in the oxygen channel can pass through the oxygenation module.

[0023] On the other hand, an extracorporeal membrane oxygenation (ECMO) device is provided, comprising the oxygenator described in any one of the above-mentioned methods.

[0024] The beneficial effects of this invention are:

[0025] The oxygenator provided by this invention has a heat exchange module that can exchange heat with the blood in the blood flow channel and the blood in the oxygenation module, respectively. That is, the blood exchanges heat with the heat exchange module for the first time in the blood flow channel. After the blood flows from the blood flow channel into the oxygenation module, the blood in the oxygenation module exchanges heat with the heat exchange module again. The oxygenated blood flows out through the blood outlet, realizing two heat exchanges of the blood, thereby keeping the blood warm. Moreover, the structure of this oxygenator does not increase the pre-filled blood volume compared with the heating method of the prior art using heating wires or other heating elements, making it suitable for use in infants. Attached Figure Description

[0026] Figure 1 This is a schematic diagram of the oxygenator provided in an embodiment of the present invention;

[0027] Figure 2 This is a cross-sectional view of the oxygenator provided in an embodiment of the present invention;

[0028] Figure 3 This is a schematic diagram of the internal structure of the oxygenator provided in an embodiment of the present invention;

[0029] Figure 4 This is a schematic diagram of the heat exchange medium flow channel provided in an embodiment of the present invention;

[0030] Figure 5 This is a partial structural diagram of the internal structure of the oxygen generator provided in an embodiment of the present invention;

[0031] Figure 6 This is a schematic diagram of the connection between the first auxiliary component and the second auxiliary component and the heat exchange module provided in an embodiment of the present invention;

[0032] Figure 7 This is a cross-sectional view of the connection between the first auxiliary component and the second auxiliary component provided in the embodiment of the present invention and the heat exchange module and the guide cone;

[0033] Figure 8 This is a flowchart of the oxygenator assembly method provided in the embodiments of the present invention.

[0034] In the picture:

[0035] 1. Outer shell; 2. Blood flow channel; 3. Oxygenation module; 5. Guide cone; 6. First seal; 7. Second seal;

[0036] 11. Shell body; 12. First end cap; 121. Protrusion; 13. Blood inlet; 131. Blood inlet pipe; 14. Blood outlet; 141. Blood discharge pipe; 15. Heat exchange medium inlet; 151. Heat exchange medium inlet pipe; 16. Heat exchange medium outlet; 161. Heat exchange medium discharge pipe; 17. Second end cap; 18. Oxygen inlet; 181. Oxygen inlet pipe; 19. Oxygen outlet;

[0037] 41. First heat exchange medium flow channel; 42. Second heat exchange medium flow channel; 43. Heat exchange chamber plate; 431. Second insertion slot; 44. First heat exchange chamber; 45. Second heat exchange chamber; 46. Partition plate; 47. Flow port;

[0038] 51. First connecting hole;

[0039] 100. First auxiliary component; 101. First insertion slot; 102. Limiting slot; 103. First flange plate; 104. First fixing hole; 200. Second auxiliary component; 201. Insertion plate; 202. Second connecting hole; 203. Positioning protrusion; 204. Second flange plate; 205. Second fixing hole; 300. Connector. Detailed Implementation

[0040] 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.

[0041] 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.

[0042] 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.

[0043] The oxygenator is one of the core components of ECMO, responsible for enabling lung function and facilitating the exchange of carbon dioxide and oxygen in the blood. Currently, there are very few oxygenators designed specifically for infants, and existing oxygenators suitable for infants either lack heat exchange capabilities or have excessively high pre-fill volumes. Therefore, this embodiment provides an oxygenator to address these issues.

[0044] like Figures 1 to 3 As shown, the oxygenator provided in this embodiment includes a shell 1, a blood flow channel 2, an oxygenation module 3, and a heat exchange module. The shell 1 has a blood inlet 13 and a blood outlet 14. The blood flow channel 2 is disposed inside the shell 1, and blood flows into the blood flow channel 2 through the blood inlet 13. The oxygenation module is disposed inside the shell 1, and is connected to the blood flow channel 2 and the blood outlet 14, allowing blood to flow along the blood flow channel 2 through the oxygenation module 3 to the blood outlet 14. The heat exchange module is disposed inside the shell 1, and can exchange heat with the blood in the blood flow channel 2 and the blood in the oxygenation module, respectively. That is, the blood undergoes a first heat exchange with the heat exchange module in the blood flow channel 2, and after flowing into the oxygenation module 3 from the blood flow channel 2, the blood in the oxygenation module 3 exchanges heat with the heat exchange module again. The oxygenated blood then flows out through the blood outlet 14, achieving two heat exchanges with the blood, thereby maintaining the temperature of the blood. Furthermore, the structure of this oxygenator does not increase the pre-filled blood volume compared to existing technologies that use heating elements such as heating wires, making it suitable for infants.

[0045] In some embodiments, the outer shell 1 includes a shell body 11, which is a hollow shell with openings at both ends. One end of the shell body 11 is provided with a first end cap 12, and the other end of the shell body 11 is provided with a second end cap 17. The first end cap 12, the second end cap 17 and the shell body 11 surround and form an outer shell 1 with a closed cavity.

[0046] Optionally, the first end cap 12 and the second end cap 17 are both cylindrical structures with one open end. The edges of the first end cap 12 and the second end cap 17 are respectively provided with insertion blocks, and the end face of the shell body 11 is provided with insertion grooves. The insertion blocks are inserted into the insertion grooves, thus achieving the connection between the first end cap 12 and the second end cap 17 and the shell body 11. The connection structure is simple. Furthermore, the insertion blocks are fixed in the insertion grooves by welding or bonding, improving the stability of the connection between the first end cap 12 and the second end cap 17 and the shell body 11.

[0047] In some embodiments, the heat exchange module has a cylindrical structure, with the blood flow channel 2 disposed within the inner cavity of the heat exchange module and the oxygenation module 3 sleeved on the outer periphery of the heat exchange module. The relative positions of the blood flow channel 2, the heat exchange module, and the oxygenation module 3 allow the heat exchange module to exchange heat with the blood in the blood flow channel 2 and the blood in the oxygenation module 3 respectively, increasing the heat exchange area and resulting in a compact structure. Furthermore, when the blood flow channel 2 or the oxygenation module 3 is not in contact with the heat exchange module, heat exchange can occur through thermal radiation. When the blood flow channel 2 or the oxygenation module 3 is in contact with the heat exchange module, heat exchange can occur through direct contact.

[0048] Optionally, the inner cavity of the heat exchange module is provided with a flow guide cone 5, and a blood flow channel 2 is formed between the circumferential sidewall of the flow guide cone 5 and the inner sidewall of the heat exchange module. The blood in the blood flow channel 2 directly exchanges heat with the heat exchange module, thereby improving the heat exchange efficiency and heat exchange effect.

[0049] Based on the aforementioned shell structure, a protrusion 121 is provided on the inner side of the bottom wall of the first end cover 12. The blood inlet 13 is disposed through the protrusion 121, and the protrusion 121 closes one end of the heat exchange module, forming a cavity with one open end with the heat exchange module. One end of the guide cone 5 is connected to the bottom wall of the second end cover 17, and the other end of the guide cone 5 is placed in the inner cavity of the heat exchange module and extends towards the blood inlet. Blood enters through the blood inlet 13 between the circumferential sidewall of the guide cone 5 and the inner sidewall of the heat exchange module. The guide cone 5 plays the role of diverting blood, reducing the amount of blood entering the blood flow channel 2, ensuring that the blood in the blood flow channel 2 can fully exchange heat with the heat exchange module, and achieving high heat exchange efficiency.

[0050] To facilitate the connection between the oxygenator and the extracorporeal membrane oxygenation (ECMO) equipment, a blood inlet pipe 131 is connected to the blood inlet 13 of the first end cap 12, and the blood inlet pipe 131 is connected to other pipelines of the ECMO equipment.

[0051] In some embodiments, the heat exchange module includes an annular heat exchange chamber plate 43, which is a hollow plate forming a hollow heat exchange cavity. A blood flow channel 2 is disposed on the inner side of the heat exchange chamber plate 43, and an oxygenation module 3 is sleeved on the outer periphery of the heat exchange chamber plate 43, increasing the heat exchange area. Furthermore, the inner wall of the heat exchange chamber plate 43 and the circumferential sidewall of the guide cone 5 form the blood flow channel 2, allowing direct contact between the inner wall of the heat exchange chamber plate 43 and the blood within the blood flow channel 2, simplifying the structural design and improving heat exchange efficiency.

[0052] The heat exchange chamber contains the heat exchange medium, which needs to be constantly replaced to achieve effective heat exchange with the blood. Therefore, a heat exchange medium inlet 15 and a heat exchange medium outlet 16 are provided on the outer shell 1, and the heat exchange medium inlet 15 and the heat exchange medium outlet 16 are respectively connected to the heat exchange chamber. The heat exchange medium enters the heat exchange chamber through the heat exchange medium inlet 15, and after heat exchange, the heat exchange medium is discharged through the heat exchange medium outlet 16, continuously replacing the heat exchange medium to ensure effective heat exchange with the blood.

[0053] Furthermore, a heat exchange medium flow channel is provided inside one end of the outer shell 1. The heat exchange medium flow channel is connected to the heat exchange chamber. The heat exchange medium inlet 15 and the heat exchange medium outlet 16 are both located at one end of the outer shell 1, and the heat exchange medium inlet 15 and the heat exchange medium outlet 16 are respectively connected to the heat exchange medium flow channel. The heat exchange medium flowing in through the heat exchange medium inlet 15 flows through the end of the heat exchange chamber away from the heat exchange medium flow channel and then flows out from the heat exchange medium outlet 16, ensuring that the heat exchange medium and the blood exchange heat fully.

[0054] Optionally, the heat exchange medium flow channel is disposed inside the first end cover 12, and the heat exchange medium inlet 15 and the heat exchange medium outlet 16 are both disposed on the first end cover 12. One end of the heat exchange chamber plate 43 is open, and the open end of the heat exchange chamber plate 43 communicates with the heat exchange medium flow channel, while the other end of the heat exchange chamber plate 43 extends toward the second end cover 17.

[0055] Furthermore, a heat exchange medium channel is disposed on the aforementioned protrusion 121, and the heat exchange medium channel surrounds the blood inlet 13. One end of the heat exchange chamber plate 43 with an opening is connected to the protrusion 121, and the heat exchange chamber communicates with the heat exchange medium channel. Optionally, an installation groove is provided on the protrusion 121 surrounding the heat exchange medium channel, and the heat exchange chamber plate 43 is inserted into the installation groove, so that the connection between the protrusion 121 and the heat exchange chamber plate 43 is sealed, thereby forming a closed channel for the heat exchange medium to flow between the heat exchange medium channel and the heat exchange chamber.

[0056] The first end cap 12 is provided with a heat exchange medium inlet pipe 151 and a heat exchange medium outlet pipe 161. One end of the heat exchange medium inlet pipe 151 passes through the side wall and protrusion 121 of the first end cap 12 in sequence and communicates with the heat exchange medium flow channel. The other end of the heat exchange medium inlet pipe 151 is placed on the outside of the first end cap 12 for connection with other pipelines of the extracorporeal membrane oxygenation (ECMO) device. One end of the heat exchange medium outlet pipe 161 passes through the side wall and protrusion 121 of the first end cap 12 in sequence and communicates with the heat exchange medium flow channel. The other end of the heat exchange medium outlet pipe 161 is placed on the outside of the first end cap 12 for connection with other pipelines of the extracorporeal membrane oxygenation (ECMO) device.

[0057] In some embodiments, combined with Figure 3 and Figure 4 As shown, the heat exchange medium flow channels include a first heat exchange medium flow channel 41 and a second heat exchange medium flow channel 42. The first heat exchange medium flow channel 41 is connected to the heat exchange medium inlet 15, and the second heat exchange medium flow channel 42 is connected to the heat exchange medium outlet 16. The heat exchange chambers include a first heat exchange chamber 44 and a second heat exchange chamber 45. One end of the first heat exchange chamber 44 is connected to the first heat exchange medium flow channel 41, and the other end of the first heat exchange chamber 44 is connected to one end of the second heat exchange chamber 45. The other end of the second heat exchange chamber 45 is connected to the second heat exchange medium flow channel 42. The heat exchange medium enters the first heat exchange medium flow channel 41 through the heat exchange medium inlet 15, then enters the first heat exchange chamber 44, flows to the other end of the first heat exchange chamber 44, and then enters the second heat exchange chamber 45. From one end of the second heat exchange chamber 45, it flows to the other end and enters the second heat exchange medium flow channel 42, and then is discharged through the heat exchange medium outlet 16. The first heat exchange medium flow channel 41 serves to connect the heat exchange medium inlet 15 and the first heat exchange chamber 44, while the second heat exchange medium flow channel 42 serves to connect the heat exchange medium outlet 16 and the second heat exchange chamber 45. The heat exchange medium flows in an orderly manner within the heat exchange chamber, enabling the heat exchange medium to fully exchange heat with the blood in the blood flow channel 2 and the blood in the oxygenation module 3, thereby improving the heat exchange efficiency.

[0058] Optionally, refer to Figure 2 and Figure 5 As shown, the heat exchange medium flow channel has an annular structure, and two partition plates 46 are provided inside the heat exchange medium flow channel. One end of each partition plate 46 is placed inside the heat exchange medium flow channel, dividing the heat exchange medium flow channel into a first heat exchange medium flow channel 41 and a second heat exchange medium flow channel 42. The other ends of the two partition plates 46 extend into the heat exchange cavity, dividing the heat exchange cavity into a first heat exchange cavity 44 and a second heat exchange cavity 45. The structure is simple and easy to assemble. In some other embodiments, a first partition can be separately provided inside the heat exchange medium flow channel to divide the heat exchange medium flow channel into the first heat exchange medium flow channel 41 and the second heat exchange medium flow channel 42, and a second partition can be provided inside the heat exchange cavity to divide the heat exchange cavity into the first heat exchange cavity 44 and the second heat exchange cavity 45.

[0059] Based on the above, the outer shell 1 is provided with a blood inlet 13, a heat exchange medium inlet 15, and a heat exchange medium outlet 16. The blood inlet 13 is perpendicular to the heat exchange medium inlet 15 and the heat exchange medium outlet 16, respectively, so as to achieve better heat exchange between the blood and the heat exchange medium.

[0060] Continue to refer to Figure 2 and Figure 3 As shown, the oxygenation module 3 is sleeved around the outer periphery of the heat exchange module. The oxygenation module 3 includes oxygenation membrane fibers that are wound around the outside of the heat exchange module. The blood inside the oxygenation module 3 can contact the heat exchange module for heat exchange, resulting in good heat exchange efficiency. Furthermore, the connection structure between the oxygenation module 3 and the heat exchange module is compact, reducing the volume of the oxygenator. Further, the outer shell 1 is sleeved around the oxygenation membrane fibers, and the inner wall of the outer shell 1 contacts the oxygenation module 3. This not only improves the structural compactness of the oxygenator but also ensures that the blood flows completely through the oxygenation module 3 for oxygenation.

[0061] A first sealing element 6 is formed at the first end of the oxygenation membrane filament by potting adhesive, and a second sealing element 7 is formed at the second end of the oxygenation membrane filament. The first sealing element 6 and the second sealing element 7 are respectively disposed within the shell body 11 of the outer casing 1. The first sealing element 6 is disposed around the heat exchange chamber plate 43, and one end face of the first sealing element 6 is spaced apart from the bottom of the first end cover 12. The oxygenation membrane filament passes through the first sealing element 6 and communicates with the interior of the first end cover 12. The second sealing element 7 is disposed around the heat exchange chamber plate 43, and one end face of the second sealing element 7 is spaced apart from the bottom of the second end cover 17. The oxygenation membrane filament passes through the second sealing element 7 and communicates with the interior of the second end cover 17. A flow port 47 is provided on the side wall of the end of the heat exchange chamber plate 43 away from the heat exchange medium flow channel. The flow port 47 connects the inner side of the heat exchange chamber plate 43 and the oxygenation module 3, allowing blood between the guide cone 5 and the heat exchange chamber plate 43 to enter the oxygenation module 3.

[0062] Blood in the blood flow channel 2 flows from the end of the oxygenation membrane wire near the second seal 7 to the end of the oxygenation membrane wire near the first seal 6. The oxygenated blood within the oxygenation membrane wire is discharged through the blood outlet 14. To ensure sufficient oxygenation of the blood within the oxygenation membrane wire, the blood outlet 14 is preferably located at the end of the outer shell 1 near the blood inlet 13, allowing the blood to be discharged after sufficient oxygenation according to the blood flow direction. Furthermore, the blood outlet 14 is located on the shell body 11, and a blood discharge pipe 141 is provided at the blood outlet 14, connecting to other pipelines of the extracorporeal membrane oxygenation (ECMO) device.

[0063] Oxygen needs to be introduced into the oxygenation membrane wire to oxygenate the blood inside the oxygenation membrane wire. Specifically, an oxygen inlet 18 and an oxygen outlet 19 are provided on the outer shell 1. An oxygen channel is provided inside the outer shell 1. One end of the oxygen channel is connected to the oxygen inlet 18, and the other end of the oxygen channel is connected to the oxygen outlet 19. The oxygen in the oxygen channel can pass through the oxygenation membrane wire.

[0064] Optionally, an oxygen flow channel is provided according to the aforementioned direction of blood flow within the blood flow channel 2 and the oxygenation module 3. Specifically, a first oxygen channel is formed between the first seal 6 and the end of the outer shell 1, and the first oxygen channel is connected to the oxygen outlet 19. A second oxygen channel is formed between the second seal 7 and the end of the outer shell 1, and the second oxygen channel is connected to the oxygen inlet 18. The gaps between the oxygenation membrane filaments of the oxygenation module 3 are also part of the oxygen channel. Oxygen enters the second oxygen channel through the oxygen inlet 18, then flows through the oxygenation membrane filaments and is oxygenated with the blood. The exchanged carbon dioxide enters the first oxygen channel and is discharged through the oxygen outlet 19. The direction of oxygen flow within the oxygenator is basically consistent with the direction of blood flow within the oxygenation membrane filaments, ensuring that the blood is fully oxygenated.

[0065] According to the structure of the outer casing 1 described above, the first oxygen channel is located between the first sealing member 6 and the bottom of the first end cover 12, and the second oxygen channel is located between the second sealing member 7 and the bottom of the second end cover 17. The oxygen inlet 18 is located on the second end cover 17, and an oxygen inlet pipe 181 is provided at the oxygen inlet 18. The oxygen inlet pipe 181 is used to connect with external oxygen equipment, and the oxygen outlet 19 is located on the first end cover 12.

[0066] This embodiment also provides an extracorporeal membrane oxygenation (ECMO) setup, including the oxygenator described in any of the above embodiments.

[0067] like Figure 6 and Figure 7 As shown, when assembling the above-mentioned oxygenator, it is necessary to ensure that the gap and parallelism between the heat exchange module and the guide cone 5 meet the assembly requirements. Therefore, this embodiment also provides an oxygenator installation and positioning structure for assembling the above-mentioned oxygenator and ensuring that the gap and parallelism between the heat exchange module and the guide cone 5 are within the assembly requirements.

[0068] Specifically, the oxygenator's installation and positioning structure includes a first auxiliary component 100 and a second auxiliary component 200. One end of the first auxiliary component 100 is detachably connected to one end of the heat exchange module, and one end of the second auxiliary component 200 is detachably connected to the other end of the heat exchange module. One end of the flow guide cone 5 can be detachably connected to one end of the second auxiliary component 200, and the other end of the flow guide cone 5 can abut against one end face of the first auxiliary component 100. The second auxiliary component enables the flow guide cone 5 to be coaxially arranged with the heat exchange module, so that a uniform blood flow channel 2 is formed between the circumferential sidewall of the flow guide cone 5 and the inner sidewall of the heat exchange module.

[0069] In the oxygenator installation and positioning structure provided in this embodiment, the first auxiliary component 100 is connected to one end of the heat exchange module to fix the position of the heat exchange module, the second auxiliary component 200 is connected to the other end of the heat exchange module, and the guide cone 5 is detachably connected to the second auxiliary component 200 to fix the relative position of the guide cone 5 and the heat exchange module. The second auxiliary component 200 is provided to make the guide cone 5 and the heat exchange module coaxial, ensuring that the gap and parallelism between the heat exchange module and the guide cone 5 can meet the assembly requirements, thereby improving the yield and performance of the oxygenator.

[0070] Optionally, the heat exchange module includes a heat exchange chamber plate 43, one end of the first auxiliary component 100 is detachably connected to one end of the heat exchange chamber plate 43, and one end of the second auxiliary component 200 is detachably connected to the other end of the heat exchange chamber plate 43.

[0071] Alternatively, one end of the heat exchange chamber plate 43 is open and extends through the heat exchange chamber. The first auxiliary component 100 is provided with an annular first insertion groove 101. The open end of the heat exchange chamber plate 43 can be inserted into the first insertion groove 101, which facilitates the installation and disassembly of the first auxiliary component 100 and has a simple structure.

[0072] The inner side plate of the heat exchange chamber plate 43 with the opening is shorter than the outer side plate. The first auxiliary member 100 is as described above. Figure 2 The structure of the protrusion 121 in the first end cap 12 shown is matched. The protrusion 121 is provided with two annular first insertion slots 101. The inner and outer plates of the heat exchange chamber plate 43 are inserted into the corresponding first insertion slots 101. Part of the protrusion 121 is placed inside the heat exchange chamber and inside the heat exchange chamber plate 43.

[0073] The other end of the first auxiliary component 100 is provided with a first flange plate 103, and the first flange plate 103 is provided with a first fixing hole 104. The first fixing hole 104 is used to fix the first flange plate 103 to other equipment so as to fix the heat exchange chamber plate 43. In addition, the first flange plate 103 can also be used to cooperate with the winding and glue filling of the oxygen film filament, and to limit the position of the oxygen film filament winding.

[0074] Alternatively, the other end of the heat exchange chamber plate 43 is provided with an annular second insertion groove 431, and one end of the second auxiliary component 200 is inserted into the second insertion groove 431, which facilitates the installation and disassembly of the second auxiliary component 200 and has a simple structure.

[0075] One end of the second auxiliary component 200 is provided with a plug-in plate 201, which is inserted into the second plug-in slot 431.

[0076] The other end of the second auxiliary component 200 is provided with a second flange plate 204, and the second flange plate 204 is provided with a second fixing hole 205. The second fixing hole 205 is used to fix the second flange plate 204 to other equipment so as to fix the heat exchange chamber plate 43. In addition, the second flange plate 204 can also be used to cooperate with the winding and glue filling of the oxygen film filament, and to limit the position of the oxygen film filament winding.

[0077] Continue to refer to Figure 7 As shown, the guide cone 5 and the second auxiliary component 200 are detachably connected. Specifically, the end of the guide cone 5 connected to the second auxiliary component 200 is provided with a first connecting hole 51, and the second auxiliary component 200 is provided with a second connecting hole 202. The connector 300 can be connected to the first connecting hole 51 through the second connecting hole 202, thus realizing the connection between the guide cone 5 and the second auxiliary component 200. The connector 300 can be disassembled and installed on the side of the second auxiliary component 200 opposite to the guide cone 5, which facilitates the disassembly and installation of the guide cone 5.

[0078] Optionally, the first connecting hole 51 is a stepped hole, and one end of the second auxiliary component 200 is provided with a positioning protrusion 203. The second connecting hole 202 passes through the positioning protrusion 203, and the positioning protrusion 203 is inserted into the first connecting hole 51. The connector 300 passes through the second connecting hole 202 and connects to the first connecting hole 51. The positioning protrusion 203 serves to limit the relative position of the guide cone 5 and the second auxiliary component 200, so that the first connecting hole 51 and the second connecting hole 202 are aligned, which facilitates the installation of the connector 300 and thus improves the installation efficiency of the guide cone 5 on the second auxiliary component 200.

[0079] The first connecting hole 51 can be a threaded hole, and the connector 300 is a screw-in connector. The screw-in connector passes through the second connecting hole 202 and is screwed into the first connecting hole 51.

[0080] The other end of the guide cone 5 abuts against one end face of the first auxiliary component 100. Optionally, a limiting groove 102 is provided on one end face of the first auxiliary component 100, and the other end of the guide cone 5 abuts against the limiting groove 102. The limiting groove 102 plays a limiting role for the guide cone 5, ensuring that the gap and parallelism between the circumferential sidewall of the other end of the guide cone 5 and the inner sidewall of the heat exchange module meet the assembly requirements.

[0081] When assembling the oxygenator, the aforementioned oxygenator mounting and positioning structure is used. Specifically, as follows: Figure 8 As shown, the assembly method of the oxygenator mainly includes the following steps:

[0082] Install the first auxiliary component 100 at one end of the heat exchange module;

[0083] Install the guide cone 5 onto the second auxiliary component 200;

[0084] The second auxiliary component 200 is installed at the other end of the heat exchange module, and the guide cone 5 is placed in the inner cavity of the heat exchange module.

[0085] The first auxiliary component 100 is connected to one end of the heat exchange module to fix the position of the heat exchange module. The second auxiliary component 200 is connected to the other end of the heat exchange module. The guide cone 5 is detachably connected to the second auxiliary component 200 to fix the relative position of the guide cone 5 and the heat exchange module. The second auxiliary component 200 can make the guide cone 5 and the heat exchange module coaxial, ensuring that the gap and parallelism between the heat exchange module and the guide cone 5 can meet the assembly requirements, thereby improving the yield and performance of the oxygenator.

[0086] The assembly method of the oxygenator provided in this embodiment is described in detail below. The assembly method includes the following steps:

[0087] Step 1: Install the first auxiliary component 100 at one end of the heat exchange module.

[0088] Specifically, the heat exchange chamber plate 43 has an open end that is inserted into the first insertion slot 101 on the first auxiliary component 100, and the first flange plate 103 on the first auxiliary component 100 can be fixed to other equipment to facilitate the assembly of other components of the oxygenator.

[0089] Step 2: Install the guide cone 5 onto the second auxiliary component 200.

[0090] Specifically, the guide cone 5 is installed on the second auxiliary component 200 by connecting the second connecting hole 202 through the connector 300 and connecting it to the first connecting hole 51 on the guide cone 5.

[0091] Step 3: Install the second auxiliary component 200 at the other end of the heat exchange module, and place the guide cone 5 in the inner cavity of the heat exchange module.

[0092] Specifically, the plug-in plate 201 provided on the second auxiliary component 200 is plugged into the second plug-in slot 431 of the heat exchange chamber plate 43, the guide cone 5 is placed in the inner cavity of the heat exchange module, and the relative position between the guide cone 5 and the inner side wall of the heat exchange module is fixed.

[0093] The second flange plate 204 on the second auxiliary component 200 can be fixed to other equipment to facilitate the assembly of other components of the oxygenator.

[0094] Step 4: Wrap the oxygenated membrane wire around the outer periphery of the heat exchange module.

[0095] Specifically, the flow port 47 on the heat exchange chamber plate 43 of the heat exchange module is located at the position where the oxygen film wire is wound, and the flow port 47 connects the inner side of the heat exchange chamber plate 43 and the oxygen film wire.

[0096] Step 5: Install the shell body 11 on the outer periphery of the oxygen membrane filament.

[0097] Specifically, such as Figure 3 As shown, the gap between the shell body 11 and the oxygenation membrane filament is smaller than the preset gap value, ensuring that blood can enter the oxygenation membrane filament for oxygenation and reducing the amount of blood entering the space between the oxygenation membrane filament and the shell body 11.

[0098] Step 6: Place the shell body 11 along the axial direction of the shell body 11, and inject glue into the lower part of the oxygen film filaments to bond the shell body 11 and the heat exchange module to the oxygen film filaments.

[0099] Specifically, in combination Figure 3 and Figure 7 As shown, the first flange plate 103 of the first auxiliary component 100 is fixed, the second auxiliary component 200 is placed above the first auxiliary component 100, and glue is injected into the part of the oxygen film filament near the first auxiliary component 100. At the same time, the shell body 11 and the heat exchange module are bonded to the oxygen film filament. After the glue solidifies, the part of the oxygen film filament injected with glue forms the first sealing component 6.

[0100] Step 7: After the glue has solidified, rotate the shell body 11 180°.

[0101] Step 8: Apply adhesive to the lower oxygen film filaments to bond the shell body 11 and the heat exchange module to the oxygen film filaments, and deform the heat exchange module to clamp one end of the guide cone 5.

[0102] Specifically, in combination Figure 3 and Figure 7 As shown, the fixing of the first flange plate 103 is released, the heat exchange module 180° is flipped, and the second flange plate 204 of the second auxiliary component 200 is fixed, with the first auxiliary component 100 placed above the second auxiliary component 200. Adhesive is injected into the portion of the oxygenation module 3 near the second auxiliary component 200, simultaneously bonding the shell body 11 and the heat exchange module to the oxygenation membrane filaments. After the adhesive solidifies, the portion of the oxygenation membrane filaments injected with adhesive forms the second sealing element 7, and the heat exchange chamber plate 43 of the heat exchange module deforms to clamp one end of the guide cone 5, fixing the guide cone 5 to the heat exchange chamber plate 43.

[0103] Step 9: After the glue has solidified, oxygenation module 3 is formed. Then, the first auxiliary component 100 and the second auxiliary component 200 are disassembled.

[0104] Specifically, the fixation of the second flange plate 204 is released, and the first auxiliary component 100 and the second auxiliary component 200 are disassembled, separating the first auxiliary component 100 and the second auxiliary component 200 from the heat exchange module. The potted oxygenated film filaments form the oxygenated module 3.

[0105] Step 10: Cut both ends of the oxygenation module 3 so that the two ends of the oxygenation module 3 are flush with the two ends of the heat exchange module.

[0106] Step 11, Installation Figure 3 The first end 12 shown covers one end of the shell body 11.

[0107] Specifically, a first end cap 12 is installed at one end of the shell body 11 to close one end of the shell body 11, and the connection between the first end cap 12 and the shell body 11 is bonded with sealant.

[0108] Step 12, Installation Figure 3 The second end cap 17 shown is located at the other end of the shell body 11.

[0109] Specifically, a second end cap 17 is installed at the other end of the shell body 11 to close the other end of the shell body 11, and the connection between the second end cap 17 and the shell body 11 is bonded with sealant.

[0110] 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) is provided with a blood inlet (13) and a blood outlet (14). Blood flow channel (2) is provided inside the outer shell (1), and blood flows into the blood flow channel (2) through the blood inlet (13). An oxygenation module (3) is disposed inside the outer shell (1). The oxygenation module (3) is connected to the blood flow channel (2) and the blood outlet (14). Blood can flow along the blood flow channel (2) through the oxygenation module (3) to the blood outlet (14). A heat exchange module is disposed inside the outer shell (1), and the heat exchange module can exchange heat with the blood in the blood flow channel (2) and the blood in the oxygenation module (3) respectively; The heat exchange module includes an annular heat exchange chamber plate (43), which is a hollow plate forming a hollow heat exchange chamber inside; The heat exchange module further includes a heat exchange medium flow channel disposed inside one end of the outer shell (1), and the heat exchange medium flow channel is connected to the heat exchange cavity; The heat exchange medium flow channel includes a first heat exchange medium flow channel (41) and a second heat exchange medium flow channel (42). The heat exchange cavity includes a first heat exchange cavity (44) and a second heat exchange cavity (45). One end of the first heat exchange cavity (44) is connected to the first heat exchange medium flow channel (41), and the other end of the first heat exchange cavity (44) is connected to one end of the second heat exchange cavity (45). The other end of the second heat exchange cavity (45) is connected to the second heat exchange medium flow channel (42). The heat exchange medium flow channel has an annular structure. Two partition plates (46) are provided in the heat exchange medium flow channel. One end of the two partition plates (46) is placed in the heat exchange medium flow channel and divides the heat exchange medium flow channel into the first heat exchange medium flow channel (41) and the second heat exchange medium flow channel (42). The other ends of the two partition plates (46) extend into the heat exchange cavity and divide the heat exchange cavity into the first heat exchange cavity (44) and the second heat exchange cavity (45).

2. The oxygenator according to claim 1, characterized in that, The heat exchange module has a cylindrical structure, the blood flow channel (2) is located in the inner cavity of the heat exchange module, and the oxygenation module (3) is sleeved on the outer periphery of the heat exchange module.

3. The oxygenator according to claim 2, characterized in that, The heat exchange module has a flow guide cone (5) in its inner cavity, and the blood flow channel (2) is formed between the circumferential sidewall of the flow guide cone (5) and the inner sidewall of the heat exchange module.

4. The oxygenator according to claim 2, characterized in that, The oxygenation module (3) includes oxygenation membrane filaments, which are wound around the outside of the heat exchange module.

5. The oxygenator according to claim 2, characterized in that, The outer shell (1) is provided with a heat exchange medium inlet (15) and a heat exchange medium outlet (16). The heat exchange medium inlet (15) and the heat exchange medium outlet (16) are respectively connected to the heat exchange chamber, the blood flow channel (2) is located on the inner side of the heat exchange chamber plate (43), and the oxygenation module (3) is sleeved on the outer periphery of the heat exchange chamber plate (43).

6. The oxygenator according to claim 5, characterized in that, The heat exchange medium inlet (15) and the heat exchange medium outlet (16) are both located at one end of the outer shell (1) and are respectively connected to the heat exchange medium flow channel. The heat exchange medium flowing in through the heat exchange medium inlet (15) can flow through the end of the heat exchange cavity away from the heat exchange medium flow channel and then flow out from the heat exchange medium outlet (16).

7. The oxygenator according to claim 6, characterized in that, The first heat exchange medium channel (41) is connected to the heat exchange medium inlet (15), and the second heat exchange medium channel (42) is connected to the heat exchange medium outlet (16).

8. The oxygenator according to claim 5, characterized in that, The blood outlet (14) is perpendicular to the heat exchange medium inlet (15) and the heat exchange medium outlet (16), respectively.

9. The oxygenator according to claim 1, characterized in that, The outer shell (1) is provided with an oxygen outlet (19) and an oxygen inlet (18). An oxygen channel is provided inside the outer shell (1). One end of the oxygen channel is connected to the oxygen inlet (18), and the other end of the oxygen channel is connected to the oxygen outlet (19). The oxygen in the oxygen channel can pass through the oxygenation module (3).

10. An extracorporeal membrane oxygenation (ECMO) device, characterized in that, The oxygenator included in any one of claims 1-9.

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