Oxygenator and extracorporeal membrane oxygenation device

Abstract

The application discloses an oxygenator and an extracorporeal membrane oxygenation device, and relates to the technical field of medical devices, in particular to an oxygenator and an extracorporeal membrane oxygenation device. The oxygenator comprises a shell (1), a blood inlet (101) is arranged on the upper end cover (112) of the shell (1), and a blood outlet (102) is arranged on the lower end cover (113); an oxygenation chamber (2) is arranged in the shell (1), and the axes of the blood inlet (101) and the blood outlet (102) coincide with the axis of the oxygenation chamber (2). The oxygenator is characterized in that the blood inlet and the blood outlet are arranged in the middle of the oxygenation chamber, blood entering the oxygenation chamber is uniformly diffused to all directions, and then flows to the blood outlet from top to bottom under the action of gravity, the flow field and the pressure field in the oxygenation chamber are uniformly distributed, blood flow has low resistance and short blood residence time, and flow dead zones or flow disturbance zones can be eliminated, so that the probability of thrombosis is reduced.

Description

Technical Field

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

[0002] Extracorporeal membrane oxygenation (ECMO) represents advanced technology in the field of extracorporeal circulation, and the oxygenator (membrane lung) is the key core component of the ECMO system, whose main functions are blood oxygen exchange and carbon dioxide removal. In the research and design of the membrane lung, the design of the blood flow path, gas path, and heat exchange water path is crucial, as they directly affect the membrane lung's gas-blood exchange performance, blood compatibility, and heat transfer performance. For example, if the blood flow and gas path design is poor, there will be many flow dead zones in the membrane lung, resulting in high resistance to blood flow. This will increase the risk of damage when blood flows through the membrane fibers, increase the probability of thrombosis, and significantly affect the efficiency of gas-blood exchange.

[0003] While ECMO (extracorporeal membrane oxygenation) has saved many patients in clinical practice, it still presents challenges such as a high incidence of thrombosis during prolonged support, reduced gas exchange efficiency, and poor biocompatibility. This is directly related to the uneven flow and pressure fields within the ECMO, the existence of flow dead zones, slow flow velocity, and prolonged blood stagnation. Thrombosis directly affects ECMO function, reduces gas exchange efficiency, and even increases the risk of thrombosis. Summary of the Invention

[0004] This application provides an oxygenator and an extracorporeal membrane oxygenation device using the oxygenator, which can uniformly distribute the flow field and pressure field in the oxygenation chamber, eliminate flow dead zones or flow disturbance zones, thereby reducing the probability of thrombosis.

[0005] The first aspect of this application provides an oxygenator, comprising:

[0006] The housing has a blood inlet on its upper end cover and a blood outlet on its lower end cover.

[0007] An oxygenation chamber is disposed within the housing, wherein the axes of the blood inlet and the blood outlet coincide with the axis of the oxygenation chamber.

[0008] In this embodiment, the oxygenator has a blood inlet and a blood outlet centrally located at the top and bottom of the oxygenation chamber. This allows the blood to diffuse evenly in the inlet buffer zone and then flow uniformly downwards to the blood outlet due to gravity. The blood flow resistance is low, gas-blood exchange is sufficient, and the blood residence time is short. Furthermore, the flow field and pressure field within the oxygenation chamber are uniformly distributed during blood flow, eliminating dead zones or flow disturbance zones, thereby reducing the probability of thrombosis.

[0009] In some embodiments, a space is formed between the upper and lower end caps of the housing and the upper and lower end faces of the oxygenation chamber, and the space between the blood inlet and the blood outlet gradually decreases in the direction away from the space.

[0010] In this embodiment, the spacer located on the upper surface of the oxygenation chamber allows blood to diffuse before entering the oxygenation chamber, resulting in better diffusion and higher efficiency without interference from the gas-blood exchange module. The spacer located on the lower surface of the oxygenation chamber extends the blood flow path, allowing blood to flow through this area before exiting the blood outlet. This places potential flow dead zones outside the oxygenation chamber, further reducing the probability of thrombosis.

[0011] In some embodiments, the inner surface of the lower end cap of the housing is conical, and the blood outlet is located at the lowest point of the conical surface.

[0012] In this embodiment, the inner surface of the lower end cover of the shell is designed as a conical surface, which allows blood around the partition space to converge towards the blood outlet, avoiding dead zones in the partition space and thus affecting blood flow performance.

[0013] In some embodiments, the upper and lower end faces of the oxygenation chamber are respectively provided with a first perforated plate and a second perforated plate, which are used to connect the oxygenation chamber and each of the interval spaces respectively.

[0014] In this embodiment, the first and second perforated plates can not only fix the gas-blood exchange module in the oxygenation chamber, but also improve the blood diffusion effect by evenly arranging the holes on the perforated plates. In addition, the second perforated plate can also drain the blood around the oxygenation chamber and reduce the occurrence of dead zones.

[0015] In some embodiments, a first ventilation chamber and a second ventilation chamber are formed between the side of the oxygenation chamber and the side of the shell for exchanging air with the outside of the shell.

[0016] In this embodiment, the first and second ventilation chambers can directly exchange blood with the blood in the oxygenation chamber, eliminating the need for an additional blood exchange module and thus simplifying the system structure.

[0017] In some embodiments, a plurality of hollow permeation tubes are arranged horizontally in the oxygenation chamber, with one end of each hollow permeation tube connected to the first ventilation chamber and the other end connected to the second ventilation chamber.

[0018] In this embodiment, a hollow osmosis tube is installed in the oxygenation chamber, and gas exchange is performed between the hollow osmosis tube and the blood in the oxygenation chamber. Although an additional gas exchange module is added, the hollow osmosis tube can be evenly distributed inside the oxygenation chamber, resulting in better gas exchange efficiency.

[0019] In some embodiments, the plurality of hollow permeation tubes are arranged in a layered and cross-shaped manner.

[0020] In this embodiment, the hollow permeation tubes are arranged horizontally and in layers, which changes the gas exchange path from one path to two paths. Combined with the characteristic of blood diffusion in all directions in this embodiment, the gas exchange efficiency of the membrane fibers can be greatly improved, thereby enhancing the efficacy of the membrane lung.

[0021] In some embodiments, the oxygenator further includes:

[0022] A heat exchange chamber is disposed within the shell, the lower end face of the heat exchange chamber is connected to the upper end face of the oxygenation chamber, and the axis of the heat exchange chamber coincides with the axis of the oxygenation chamber.

[0023] In this embodiment, the oxygenator is improved by adding a heat exchange chamber based on the previous embodiment, so that the oxygenator can integrate heat exchange function without changing the original performance.

[0024] In some embodiments, a third perforated plate is provided on the upper end face of the heat exchange chamber.

[0025] In this embodiment, the third perforated plate is used to connect the heat exchange chamber and the blood inlet or the space between them, and also has the function of improving the diffusion effect of blood.

[0026] In some embodiments, a first heat exchange cavity and a second heat exchange cavity are formed between the side of the heat exchange chamber and the side of the shell for heat exchange with the outside of the shell.

[0027] In this embodiment, the first heat exchange chamber and the second heat exchange chamber can directly exchange heat with the blood in the heat exchange chamber without the need for an additional air-heat exchange module, thereby simplifying the system structure.

[0028] In some embodiments, a plurality of heat exchange tubes are arranged horizontally in the heat exchange chamber, with one end of each heat exchange tube connected to the first heat exchange chamber and the other end connected to the second heat exchange chamber.

[0029] In this embodiment, heat exchange tubes are installed in the heat exchange chamber, and heat exchange is performed between the heat exchange tubes and the blood in the heat exchange chamber. Although an additional heat exchange module is added, the heat exchange tubes can be evenly distributed inside the heat exchange chamber, resulting in better heat exchange efficiency.

[0030] In some embodiments, the plurality of heat exchange tubes are arranged in a layered and cross-shaped manner.

[0031] In this embodiment, the heat exchange tubes are arranged horizontally and in a layered and cross manner, which changes the heat exchange path from one path to two paths. Combined with the characteristic of blood spreading in all directions in this embodiment, the heat exchange efficiency can be greatly improved, thereby enhancing the efficacy of the membrane lung.

[0032] A second aspect of this application provides an extracorporeal membrane oxygenation (ECMO) device, including the oxygenator described in any of the foregoing embodiments.

[0033] The above embodiments of this application have the following beneficial technical effects:

[0034] The oxygenator described in this application embodiment has a blood inlet and a blood outlet centrally located at the top and bottom of the oxygenation chamber. This allows the blood entering the oxygenation chamber to diffuse evenly in all directions and then flow evenly from top to bottom to the blood outlet due to gravity. The flow field and pressure field distribution within the oxygenation chamber are uniform, resulting in low blood flow resistance and short blood residence time. This can eliminate dead zones or flow disturbance zones, thereby reducing the probability of thrombosis. Attached Figure Description

[0035] Figure 1a This is a cross-sectional view of an oxygenator provided in an embodiment of this application;

[0036] Figure 1b This is a partially enlarged view of the blood outlet of an oxygenator provided in an embodiment of this application;

[0037] Figure 1c This is a top view of an oxygenator provided in an embodiment of this application;

[0038] Figure 1d This is a bottom view of an oxygenator provided in an embodiment of this application;

[0039] Figure 2 This is a schematic diagram of the gas path design of an oxygenator provided in an embodiment of this application;

[0040] Figure 3a This is a cross-sectional view of an oxygenator provided in an embodiment of this application;

[0041] Figure 3b This is a bottom view of an oxygenator provided in an embodiment of this application;

[0042] Figure 4 This is a schematic diagram of the water flow path design of an oxygenator provided in an embodiment of this application.

[0043] Figure label:

[0044] 1. Shell; 101. Blood inlet; 102. Blood outlet; 103. Vent; 104. Vent; 105. First blood sampling port; 106. Temperature measurement port; 107. Second blood sampling port; 108. First exhaust port; 109. Second exhaust port; 110. Heat exchange hole; 111. Heat exchange hole; 112. Upper end cover; 113. Lower end cover; 2. Oxygenation chamber; 201. Upper end face; 202. Lower end face; 3. Spacing space; 4. Spacing space; 5. Hollow permeation tube; 6. First perforated plate; 7. Second perforated plate; 8. Mounting block; 9. Connector; 10. First ventilation chamber; 11. Second ventilation chamber; 12. Heat exchange chamber; 13. Third perforated plate; 14. Heat exchange tube; 15. First heat exchange chamber; 16. Second heat exchange chamber. Detailed Implementation

[0045] To make the objectives, technical solutions, and advantages of this application clearer, the application will be further described in detail below with reference to specific embodiments and accompanying drawings. It should be understood that these descriptions are merely exemplary and not intended to limit the scope of this application. Furthermore, descriptions of well-known structures and technologies are omitted in the following description to avoid unnecessarily obscuring the concepts of this application.

[0046] The applicant discovered that while ECMO (extracorporeal membrane oxygenation) machines currently used in clinical practice have saved many patients, they still suffer from high rates of thrombosis and reduced gas exchange efficiency during prolonged support. This is directly related to the uneven blood flow and pressure fields within the ECMO machine, the existence of flow dead zones, slow flow velocity, and prolonged blood stagnation. Thrombosis directly affects ECMO function, reduces gas exchange efficiency, and even increases the risk of thrombosis.

[0047] Based on the above reasons, the applicant found in the study that by optimizing the design of the blood flow path, air path and water path of the membrane lung, the internal flow field and pressure field of the membrane lung can be uniformly distributed, the flow stagnation area is small, the blood flow resistance is low, and the gas-blood exchange efficiency and heat exchange efficiency are high, thereby improving the long-term support efficacy of the membrane lung and reducing the probability of thrombosis during long-term support.

[0048] Figure 1a This is a cross-sectional view of an oxygenator provided in an embodiment of this application; Figure 1b This is a partially enlarged view of the blood outlet of an oxygenator provided in an embodiment of this application; Figure 1c This is a top view of an oxygenator provided in an embodiment of this application; Figure 1d This is a bottom view of an oxygenator provided in an embodiment of this application.

[0049] like Figures 1a to 1d As shown, an embodiment of this application provides an oxygenator, comprising:

[0050] The housing 1 has a blood inlet 101 on its upper end cover 112 and a blood outlet 102 on its lower end cover 113.

[0051] Oxygenation chamber 2 is disposed within the housing 1, and the axes of the blood inlet 101 and the blood outlet 102 coincide with the axis of the oxygenation chamber 2.

[0052] In this embodiment, the oxygenator has a blood inlet 101 and a blood outlet 102 centrally located at the top and bottom of the oxygenation chamber 2. This allows the blood to diffuse evenly in the inlet buffer zone and then flow uniformly downwards to the blood outlet 102 due to gravity. The blood flow resistance is low, gas-blood exchange is sufficient, and the blood residence time is short. Furthermore, the flow field and pressure field within the oxygenation chamber 2 are uniformly distributed during blood flow, eliminating dead zones or flow disturbance zones, thereby reducing the probability of thrombosis.

[0053] In some embodiments, gap spaces 3 and 4 are formed between the upper and lower end caps 112 and 113 of the housing 1 and the upper and lower end faces 201 and 202 of the oxygenation chamber 2, and the space between the blood inlet 101 and the blood outlet 102 gradually decreases in the direction away from the gap spaces 3 and 4.

[0054] In this embodiment, the space 3 located on the upper end face 201 of the oxygenation chamber 2 allows blood to diffuse before entering the oxygenation chamber 2, without interference from the gas-blood exchange module, resulting in better diffusion and higher diffusion efficiency. The space 4 located on the lower end face 202 of the oxygenation chamber 2 extends the blood flow path, allowing blood to flow through this space before exiting the blood outlet 102, thus placing potential flow dead zones outside the oxygenation chamber 2 and further reducing the probability of thrombosis.

[0055] In some embodiments, the inner surface of the lower end cap 113 of the housing 1 is conical, and the blood outlet 102 is disposed at the lowest point of the conical surface.

[0056] In this embodiment, the inner surface of the lower end cover 113 of the housing 1 is designed as a conical surface, which allows blood around the partition space 4 to converge towards the blood outlet 102, avoiding the occurrence of flow dead zones in the partition space 4, thereby affecting blood flow performance.

[0057] In some embodiments, the upper and lower end faces 201 and 202 of the oxygenation chamber 2 are respectively provided with a first perforated plate 6 and a second perforated plate 7, which are used to connect the oxygenation chamber 2 and the spacer spaces 3 and 4 respectively.

[0058] In this embodiment, the first perforated plate 6 and the second perforated plate 7 can not only fix the gas-blood exchange module in the oxygenation chamber 2, but also improve the blood diffusion effect by evenly arranging the holes on the perforated plates. In addition, the second perforated plate 7 can also drain the blood around the oxygenation chamber 2 and reduce the occurrence of dead zones.

[0059] In some embodiments, a first ventilation chamber 10 and a second ventilation chamber 11 are formed between the side of the oxygenation chamber 2 and the side of the housing 1 for exchanging air with the outside of the housing 1.

[0060] In this embodiment, the first ventilation chamber 10 and the second ventilation chamber 11 can directly exchange blood gases with the blood in the oxygenation chamber 2 without the need for an additional blood gas exchange module. For example, the first ventilation chamber 10 and the second ventilation chamber 11 exchange air with the outside of the shell 1 through the air holes 103 and 104 on the shell 1, and the first ventilation chamber 10 and the second ventilation chamber 11 exchange blood gases with the blood in the oxygenation chamber 2 through the side that is in contact with the oxygenation chamber 2.

[0061] In some embodiments, a plurality of hollow permeation tubes 5 are arranged horizontally in the oxygenation chamber 2, with one end of each hollow permeation tube 5 connected to the first ventilation chamber 10 and the other end connected to the second ventilation chamber 11.

[0062] In this embodiment, a hollow permeation tube 5 is installed inside the oxygenation chamber 2. The two ends of the hollow permeation tube 5 are connected to a first ventilation chamber 10 and a second ventilation chamber 11, respectively. The first ventilation chamber 10 and the second ventilation chamber 11 exchange air with the outside environment, allowing gas to flow within the hollow permeation tube 5 and thus facilitating gas-blood exchange with the blood inside the oxygenation chamber 2. Although an additional gas-blood exchange module is added, the hollow permeation tubes 5 can be evenly distributed inside the oxygenation chamber 2, resulting in better gas-blood exchange efficiency. In this embodiment, the hollow permeation tube 5 can be a hollow fiber membrane.

[0063] In some embodiments, the plurality of hollow permeation tubes 5 are arranged in a layered and cross-shaped manner.

[0064] In this embodiment, the hollow permeation tubes 5 are arranged horizontally and in layers, which changes the gas exchange path from one path to two paths. Combined with the characteristic of blood diffusion in all directions in this embodiment, the gas exchange efficiency of the membrane fibers can be greatly improved, thereby enhancing the efficacy of the membrane lung.

[0065] In some embodiments, the oxygenator further includes:

[0066] A heat exchange chamber 12 is disposed inside the housing 1. The lower end face 202 of the heat exchange chamber 12 is connected to the upper end face 201 of the oxygenation chamber 2. The axis of the heat exchange chamber 12 coincides with the axis of the oxygenation chamber 2.

[0067] In this embodiment, the oxygenator is improved by adding a heat exchange chamber 12, so that the oxygenator can combine heat exchange function without changing its original performance.

[0068] In some embodiments, a third perforated plate 13 is provided on the upper end surface of the heat exchange chamber 12.

[0069] In this embodiment, the original first perforated plate 6 is removed, or the original first perforated plate 6 is used to connect the heat exchange chamber 12 and the oxygenation chamber 2, and the third perforated plate 13 is used to connect the heat exchange chamber 12 and the blood inlet 101 or the space 3, and also has the function of improving the diffusion effect of blood.

[0070] In some embodiments, a first heat exchange chamber 15 and a second heat exchange chamber 16 are formed between the side of the heat exchange chamber 12 and the side of the housing 1 for heat exchange with the outside of the housing 1.

[0071] In this embodiment, the first heat exchange chamber 15 and the second heat exchange chamber 16 can directly exchange heat with the blood in the heat exchange chamber 12 without the need for an additional air-to-heat exchange module. For example, the first heat exchange chamber 15 and the second heat exchange chamber 16 exchange heat with the outside of the shell 1 through heat exchange holes 110 and 111 on the outer shell, and the first heat exchange chamber 15 and the second heat exchange chamber 16 exchange heat with the blood in the heat exchanger chamber through the side connected to the heat exchange chamber 12.

[0072] In some embodiments, a plurality of heat exchange tubes 14 are arranged horizontally in the heat exchange chamber 12, with one end of each heat exchange tube 14 connected to the first heat exchange cavity 15 and the other end connected to the second heat exchange cavity 16.

[0073] In this embodiment, a heat exchange tube 14 is installed inside the heat exchange chamber 12. The two ends of the heat exchange tube 14 are connected to a first heat exchange cavity 15 and a second heat exchange cavity 16, respectively. The first heat exchange cavity 15 and the second heat exchange cavity 16 exchange heat with the outside environment, allowing a heat medium to flow inside the heat exchange tube 14, thereby exchanging heat with the blood inside the heat exchange chamber 12. Although an additional heat exchange module is added, the heat exchange tubes 14 can be evenly distributed inside the heat exchange chamber 12, resulting in better heat exchange efficiency. In this embodiment, the heat exchange tube 14 can be a water filament.

[0074] In some embodiments, the plurality of heat exchange tubes 14 are arranged in a layered and cross-shaped manner.

[0075] In this embodiment, the heat exchange tubes 14 are arranged horizontally and in a layered and cross-shaped manner, which changes the heat exchange path from one path to two paths. Combined with the characteristic of blood spreading in all directions in this embodiment, the heat exchange efficiency can be greatly improved, thereby enhancing the efficacy of the membrane lung.

[0076] In some embodiments, the blood inlet 101 is provided with a first blood sampling port 105, and the blood outlet 102 is provided with a temperature measuring port 106 and a second blood sampling port 107. The first blood sampling port 105 is used for sampling and detecting blood before oxygenation, the second blood sampling port 107 is used for sampling and detecting blood after oxygenation, and the temperature measuring port 106 is used to detect the temperature of the oxygenated blood in real time to determine whether the oxygenated blood can flow directly into the arteries and veins.

[0077] In some embodiments, the housing 1 is further provided with a mounting block 8, on which a connector 9 for connecting to the blood storage tank is mounted.

[0078] In one embodiment, the housing 1 is further provided with a first exhaust port 108, which communicates with the spacer 3; the housing 1 is also provided with a second exhaust port 109, which communicates with the spacer 4. The first exhaust port 108 and the second exhaust port 109 are used to remove air bubbles from the blood. This application also provides an extracorporeal membrane oxygenation (ECMO) system, including the oxygenator described in any of the foregoing embodiments.

[0079] The extracorporeal membrane oxygenation (ECMO) system in this embodiment possesses the advantages of the oxygenator described in any of the aforementioned embodiments, which will not be elaborated upon here.

[0080] It should be understood that the specific embodiments described above are merely illustrative or explanatory of the principles of this application and do not constitute a limitation thereof. Therefore, any modifications, equivalent substitutions, improvements, etc., made without departing from the spirit and scope of this application should be included within the protection scope of this application. Furthermore, the appended claims are intended to cover all variations and modifications falling within the scope and boundaries of the appended claims, or equivalent forms of such scope and boundaries.

Claims

1. An oxygenator comprising: The shell (1) is provided with a blood inlet (101) on the upper end cover (112) and a blood outlet (102) on the lower end cover (113); an oxygenation chamber (2) is arranged in the shell (1), the axes of the blood inlet (101) and the blood outlet (102) coincide with the axis of the oxygenation chamber (2); a first spacing space (3) is formed between the upper end cover (112) of the shell (1) and the upper end face (201) of the oxygenation chamber (2), a second spacing space (4) is formed between the lower end cover (113) of the shell (1) and the lower end face (202) of the oxygenation chamber (2), and the space of the blood inlet (101) and the blood outlet (102) gradually decreases in the direction away from the first spacing space (3) and the second spacing space (4); the inner surface of the lower end cover (113) of the shell (1) is a conical surface, and the lowest point of the conical surface is provided with the blood outlet (102); The upper and lower end faces (201, 202) of the oxygenation chamber (2) are respectively provided with a first hole plate (6) and a second hole plate (7) for respectively communicating the oxygenation chamber (2) with the first spacing space (3) and the second spacing space (4).

2. The oxygenator of claim 1, wherein, First and second gas exchange cavities (10, 11) are formed between the side face of the oxygenation chamber (2) and the side face of the shell (1) for gas exchange with the outside of the shell (1).

3. The oxygenator of claim 2, wherein, A plurality of hollow permeation tubes (5) are arranged in the oxygenation chamber (2) in the horizontal direction, one end of each of the hollow permeation tubes (5) communicates with the first gas exchange cavity (10), and the other end communicates with the second gas exchange cavity (11).

4. The oxygenator of claim 3, wherein, The plurality of hollow permeation tubes (5) are arranged in layers and cross each other.

5. The oxygenator of any one of claims 1-4, wherein, The oxygenator further comprises a heat exchange chamber (12) arranged in the shell (1), the lower end face of the heat exchange chamber (12) is connected with the upper end face (201) of the oxygenation chamber (2), and the axis of the heat exchange chamber (12) coincides with the axis of the oxygenation chamber (2).

6. The oxygenator of claim 5, wherein, The upper end face of the heat exchange chamber (12) is provided with a third hole plate (13).

7. The oxygenator of claim 6, wherein, First and second heat exchange cavities (15, 16) are formed between the side face of the heat exchange chamber (12) and the side face of the shell (1) for heat exchange with the outside of the shell (1).

8. The oxygenator of claim 7, wherein, A plurality of heat exchange tubes (14) are arranged in the heat exchange chamber (12) in the horizontal direction, one end of each of the heat exchange tubes (14) communicates with the first heat exchange cavity (15), and the other end communicates with the second heat exchange cavity (16).

9. The oxygenator of claim 8, wherein, The plurality of heat exchange tubes (14) are arranged in layers and cross each other.

10. An extracorporeal membrane oxygenation device, comprising: An oxygenator comprising any one of claims 1-9.

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