Temperature control assembly, oxygenator, ECMO device and thermostatic control method

Abstract

The application discloses a temperature control assembly, an oxygenator, an ECMO device and a constant temperature control method. The temperature control assembly is arranged in the oxygenator. The temperature control assembly is formed with a recessed heat exchange area. The heat exchange area comprises an outer flow passage area and an inner flow passage area. Heat exchange medium enters the outer flow passage area from a first end of the heat exchange area and conducts heat to blood in an oxygenation membrane filament cavity of the oxygenator through an outer peripheral side wall of the temperature control assembly. The outer flow passage area and the inner flow passage area are communicated at a second end of the heat exchange area so that the heat exchange medium enters the inner flow passage area from the outer flow passage area. The heat exchange medium in the inner flow passage area is discharged from the first end of the heat exchange area. In the ECMO device, a constant temperature water tank supplies heat exchange medium adjusted to a set temperature to the temperature control assembly of the oxygenator. The heat exchange medium transfers heat to the blood in the oxygenation membrane filament cavity in the outer flow passage area of the temperature control assembly so as to heat the blood. After heat exchange, the heat exchange medium flows from the outer flow passage area to the inner flow passage area in the temperature control assembly and returns to the constant temperature water tank. The application can be widely applied in the technical field of medical instruments.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a temperature control assembly, an oxygenator, an ECMO device and a constant temperature control method. BACKGROUND

[0002] Extracorporeal membrane oxygenation (ECMO) helps critically ill patients with severe cardiopulmonary failure to achieve continuous extracorporeal respiration and circulation, usually a motor drives the blood pump rotor to provide power for blood circulation in the oxygenator. Blood may be cooled outside the body, so the blood at the drainage site needs to be warmed. Currently, there is no good solution to maintain the temperature of extracorporeal blood. On the other hand, although the motor can generate heat during operation, the heat generated by the motor is too large and uncontrolled. Therefore, if the heat generated by the motor is conducted to the blood, it may scald the blood. Furthermore, common ECMO devices are disposable, and the cost for patients is high. SUMMARY

[0003] To solve at least one of the above technical problems, the present application provides a temperature control assembly, an oxygenator, an ECMO device and a constant temperature control method, which adopts the following technical solutions.

[0004] The temperature control assembly provided by the present application is arranged in the oxygenator, and the temperature control assembly forms a recessed heat exchange zone, which includes an outer flow passage and an inner flow passage. The heat exchange medium enters the outer flow passage from the first end of the heat exchange zone and conducts heat to the blood in the oxygenation membrane filament cavity of the oxygenator through the peripheral side wall of the temperature control assembly. The outer flow passage and the inner flow passage are communicated at the second end of the heat exchange zone to allow the heat exchange medium to enter the inner flow passage from the outer flow passage. The heat exchange medium in the inner flow passage is discharged from the first end of the heat exchange zone.

[0005] In some embodiments of the present application, the temperature control assembly includes a thermal insulation layer arranged in the heat exchange zone. The heat exchange zone is divided into the outer flow passage and the inner flow passage by the thermal insulation layer.

[0006] In some embodiments of the present application, a gap is left between the end of the thermal insulation layer and the second end in the heat exchange zone, so that the outer flow passage and the inner flow passage are communicated at the second end of the heat exchange zone.

[0007] In some embodiments of the present application, the temperature control assembly can exchange heat with the driver in the oxygenator, and the heat exchange medium in the inner flow passage absorbs the heat of the driver.

[0008] In some embodiments of the present application, a cylindrical cavity for arranging the driver is formed in the temperature control assembly.

[0009] In some embodiments of the present application, the temperature control assembly comprises an inner ring structure and an outer ring structure, the inner ring structure has an inner circumferential sidewall and an outer circumferential sidewall, the driver is arranged in a cylindrical cavity formed by the inner circumferential sidewall of the inner ring structure, the outer ring structure has an inner circumferential sidewall and an outer circumferential sidewall, the inner ring structure is arranged in a cylindrical cavity formed by the inner circumferential sidewall of the outer ring structure, and the heat exchange area is arranged between the inner ring structure and the outer ring structure.

[0010] In some embodiments of the present application, the heat insulation layer is arranged in an annular structure, and the heat insulation layer is arranged between the inner ring structure and the outer ring structure.

[0011] In some embodiments of the present application, the outer circumferential sidewall of the inner ring structure is provided with a recessed area to form the inner flow-through area, and the inner flow-through area is arranged at intervals along the circumference and has at least two, the inner circumferential sidewall of the outer ring structure is provided with a recessed area to form the outer flow-through area, and the outer flow-through area is arranged at intervals along the circumference and has at least two.

[0012] In some embodiments of the present application, the inner flow-through area is arranged as a cylindrical cavity on the outer circumferential sidewall of the inner ring structure, and the outer flow-through area is arranged as a cylindrical cavity on the inner circumferential sidewall of the outer ring structure.

[0013] In some embodiments of the present application, the heat exchange area is arranged as an annular cavity formed between the outer circumferential sidewall of the inner ring structure and the inner circumferential sidewall of the outer ring structure, and the heat insulation layer is inserted into the annular cavity to separate the annular cavity into the inner flow-through area and the outer flow-through area.

[0014] In some embodiments of the present application, the temperature control assembly comprises a first end cover, the first end cover is arranged at the first end of the temperature control assembly, the first end cover is provided with a water inlet end and a water outlet end, the water inlet end is communicated with the outer flow-through area, and the water outlet end is communicated with the inner flow-through area.

[0015] In some embodiments of the present application, one side of the first end cover is provided with an inner ring groove and an outer ring groove, the inner ring groove corresponds to the inner flow-through area, and the outer ring groove corresponds to the outer flow-through area.

[0016] The oxygenator provided by the present application comprises an oxygenator body and a temperature control assembly, the oxygenator body comprises an inner cylinder and an outer cylinder, the inner cylinder is arranged in the outer cylinder, and an area between the inner cylinder and the outer cylinder forms an oxygenation membrane wire cavity; the temperature control assembly is arranged in a cylindrical cavity formed by the inner cylinder, and the temperature control assembly is in contact with the inner cylinder for heat conduction.

[0017] In some embodiments of the present application, the oxygenator comprises a driver and a blood pump rotor, the blood pump rotor is arranged in the oxygenator body, the driver is used to drive the blood pump rotor to rotate, and the driver is arranged in the temperature control assembly.

[0018] In some embodiments of this application, the temperature control component is detachably disposed within the cylindrical cavity enclosed by the inner cylinder.

[0019] The ECMO device provided in this application includes an oxygenator and a constant temperature water tank. The constant temperature water tank supplies heat exchange medium to the external circulation zone, and the heat exchange medium in the internal circulation zone flows back to the constant temperature water tank. The constant temperature water tank adjusts the returned heat exchange medium to a set temperature.

[0020] In some embodiments of this application, the constant temperature water tank includes a heater and / or a radiator.

[0021] The constant temperature control method provided in this application is implemented using an ECMO device, and the constant temperature control method includes the following workflow:

[0022] Continuously acquire the first real-time temperature of the external circulation area and the second real-time temperature at the inlet of the constant temperature water tank;

[0023] The first real-time temperature is compared with the second real-time temperature, and the first real-time temperature is compared with the preset target temperature.

[0024] If the second real-time temperature is greater than the first real-time temperature, and the first real-time temperature is greater than the target temperature, the radiator is activated and the flow rate of the heat exchange medium is increased until the first real-time temperature reaches the target temperature.

[0025] If the second real-time temperature is greater than the first real-time temperature and the first real-time temperature is less than the target temperature, the radiator is controlled to close and the flow rate of the heat exchange medium is increased. If the first real-time temperature does not reach the target temperature within a preset time, the heater is controlled to turn on until the first real-time temperature reaches the target temperature.

[0026] If the second real-time temperature is lower than the first real-time temperature, and the first real-time temperature is higher than the target temperature, control the heater to turn off, the radiator to start, and increase the flow rate of the heat exchange medium until the first real-time temperature reaches the target temperature.

[0027] If the second real-time temperature is lower than the first real-time temperature, and the first real-time temperature is lower than the target temperature, the heater is turned on and the flow rate of the heat exchange medium is increased until the first real-time temperature reaches the target temperature.

[0028] In some embodiments of this application, the constant temperature control method further includes:

[0029] If the second real-time temperature is greater than the first real-time temperature before the first real-time temperature is adjusted to the target temperature;

[0030] After the first real-time temperature is adjusted to the target temperature, the radiator and the heater are turned off, and the heat exchange medium is controlled to be at the first preset flow rate.

[0031] In some embodiments of this application, the constant temperature control method further includes:

[0032] If the second real-time temperature is lower than the first real-time temperature before the first real-time temperature is adjusted to the target temperature;

[0033] After the first real-time temperature is adjusted to the target temperature, the heater is controlled to be in a constant temperature state, and the heat exchange medium is controlled to be at a second preset flow rate.

[0034] In some embodiments of this application, the constant temperature control method further includes:

[0035] If the first real-time temperature is greater than the preset temperature threshold range, an alarm signal is output; the temperature threshold range is determined based on the target temperature and the error tolerance.

[0036] The embodiments of this application have at least the following beneficial effects: In the ECMO device, the constant temperature water tank supplies heat exchange medium adjusted to the set temperature to the temperature control component of the oxygenator. The heat exchange medium transfers heat to the blood in the oxygenation membrane fiber cavity in the outer flow area of ​​the temperature control component, thereby raising the blood temperature. After heat exchange is completed, the heat exchange medium flows from the outer flow area to the inner flow area in the temperature control component and then flows back to the constant temperature water tank. This application can be widely applied in the field of medical device technology. Attached Figure Description

[0037] The aspects and advantages described and / or added to the embodiments of this application will become apparent and readily understood in conjunction with the following drawings. It should be noted that the embodiments illustrated in the following drawings are exemplary and are used only to explain this application, and should not be construed as limiting this application.

[0038] Figure 1-1 This is a structural diagram of an oxygenator.

[0039] Figure 1-2 for Figure 1-1 A cross-sectional view of the structure.

[0040] Figure 1-3 A structural diagram showing the assembly of the locking assembly and the oxygenator body.

[0041] Figure 1-4 This is a structural diagram of the locking assembly and the temperature control assembly.

[0042] Figure 2-1 This is a cross-sectional view of the temperature control component installed in the oxygenator, showing the flow direction of the heat exchange medium in the heat exchange zone where the temperature control component is located.

[0043] Figure 2-2This is a structural diagram of the temperature control assembly and the first end cap.

[0044] Figure 2-3 for Figure 2-1 A cross-sectional view of the structure, the first end cap is not shown in the figure, and the flow direction of the heat exchange medium in the heat exchange zone is shown in the figure.

[0045] Figure 3-1 This is a schematic diagram of a constant temperature water tank in an ECMO device, showing the flow direction of the heat exchange medium.

[0046] Figure 3-2 This is a flowchart of a temperature control method for an ECMO device.

[0047] Figure 3-3 This is a flowchart of another method for temperature control in ECMO devices.

[0048] Reference numerals: 1000, Oxygenator body; 1100, Blood pump rotor; 1201, Inner cylinder; 1202, Outer cylinder; 1203, Oxygenation membrane fiber cavity; 2100, Base; 2200, Clamping component; 2301, Clamping transmission structure; 2302, Clamping operation structure; 2401, Locking operation structure; 2402, Locking connection structure; 3100, Driver; 3200, Temperature control component; 3201, External flow area; 3202, Inner flow area; 3203, Insulation layer; 3204, Inner ring structure; 3205, Outer ring structure; 3300, First end cap; 3301, Water inlet; 3302, Water outlet; 3303, Inner ring groove; 3304, Outer ring groove; 3305, Partition; 4001, Controller; 4002, Heater; 4003, Temperature sensor; 4004, Constant temperature water tank; 4005, Radiator; 4006, Water pump. Detailed Implementation

[0049] The following is combined Figures 1-1 to 3-3 The embodiments of this application are described in detail below, examples of which are illustrated in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain this application, and should not be construed as limiting this application.

[0050] In the description of this application, it should be understood that the use of terms such as "center," "middle," "longitudinal," "transverse," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "axial," "radial," and "circumferential" to indicate orientation or positional relationships is based on the orientation or positional relationships shown in the accompanying drawings and is only for the convenience of describing this application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application. Furthermore, features defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this application, unless otherwise stated, "a plurality of" means two or more.

[0051] In the description of this application, it should be noted that, unless otherwise expressly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; 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; and they can refer to the internal connection 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.

[0052] This application relates to an oxygenator, which includes an oxygenator body 1000 and a temperature control component 3200. The temperature control component 3200 is disposed in the oxygenator body 1000, which has an oxygenation membrane fiber cavity 1203. The temperature control component 3200 is used to provide heat to the blood in the oxygenation membrane fiber cavity 1203 to maintain the temperature of the blood flowing in the oxygenator body 1000. Specifically, a heat exchange medium enters the temperature control component 3200 and exchanges heat with the blood in the oxygenation membrane fiber cavity 1203 to maintain the blood temperature.

[0053] It is understood that the oxygenator body 1000 includes an inner cylinder 1201 and an outer cylinder 1202, with the inner cylinder 1201 disposed within the outer cylinder 1202. The area between the inner cylinder 1201 and the outer cylinder 1202 forms an oxygenation membrane fiber cavity 1203. Specifically, the temperature control component 3200 is disposed within the cylindrical cavity enclosed by the inner cylinder 1201, enabling heat conduction between the temperature control component 3200 and the inner cylinder 1201. Referring to the attached drawings, the outer peripheral sidewall of the temperature control component 3200 abuts against the sidewall of the inner cylinder 1201, and heat is conducted from the outer peripheral sidewall of the temperature control component 3200 to the oxygenation membrane fiber cavity 1203.

[0054] In one embodiment, the oxygenator includes a driver 3100 and a blood pump rotor 1100. Referring to the accompanying drawings, the blood pump rotor 1100 is disposed within the oxygenator body 1000, and the driver 3100 is disposed within the temperature control assembly 3200. It is understood that the driver 3100 includes a motor, which drives the blood pump rotor 1100 to rotate, thereby pumping blood into the oxygenation membrane fiber cavity 1203.

[0055] In one implementation, the temperature control component 3200 is detachably disposed within the oxygenator. Specifically, the temperature control component 3200 is detachably disposed within the cylindrical cavity enclosed by the inner cylinder 1201. When replacing the oxygenator, the temperature control component 3200 can be removed from the old oxygenator and installed into the new oxygenator for reuse, thereby improving utilization and reducing costs.

[0056] This application relates to a locking assembly, in which a temperature control assembly 3200 is detachably mounted to an oxygenator. Specifically, the locking assembly includes a base 2100 and a clamping assembly. The clamping assembly is disposed on the base 2100, which is located on the top of the oxygenator body 1000. The temperature control assembly 3200 is connected to the oxygenator body 1000 via the clamping assembly, and the lower side of the base 2100 abuts against the top of the temperature control assembly 3200. Furthermore, the clamping assembly detachably clamps the oxygenator body 1000 to facilitate replacement of the oxygenator body 1000.

[0057] Furthermore, the clamping assembly includes clamping components 2200, which are hinged to the base 2100 and are used to detachably connect the oxygenator body 1000. Specifically, at least two clamping components 2200 are provided, spaced apart along the outer periphery of the clamping transmission structure 2301. A first end of each clamping component 2200 is hinged to the first base, and a second end is used to connect to the outer side wall of the oxygenator body 1000. It is understood that each clamping component 2200 rotates synchronously to simultaneously approach or move away from the outer side wall of the oxygenator body 1000, thereby clamping or releasing the oxygenator body 1000.

[0058] In some examples, the second end of the clamping component 2200 is provided with a clamping structure, which protrudes from the outer side wall of the clamping component 2200. Rotation of the clamping component 2200 allows the clamping structure to move closer to or further away from the outer side wall of the oxygenator body 1000. Referring to the accompanying drawings, the outer side wall of the oxygenator body 1000 is provided with an annular protrusion. The clamping structure engages and locks the lower side of the annular protrusion, thereby connecting the temperature control component 3200 to the oxygenator body 1000. Separating the clamping structure from the annular protrusion allows the temperature control component 3200 to be disassembled from the oxygenator body 1000.

[0059] In one embodiment, the clamping assembly includes a clamping transmission structure 2301, which is connected to the clamping component 2200 via a transmission structure. The clamping transmission structure 2301 is rotatably mounted on the base 2100. It is understood that the clamping transmission structure 2301 rotates on the base 2100 to drive the clamping component 2200 to rotate, thereby connecting the clamping component 2200 to the oxygenator body 1000.

[0060] Furthermore, the clamping transmission structure 2301 is disposed on the upper side wall of the base 2100, and the rotation axis of the clamping transmission structure 2301 is perpendicular to the upper side of the base 2100. Each clamping component 2200 is equally spaced around the rotation axis of the clamping transmission structure 2301 along the circumference of the base 2100. In this case, after the clamping assembly clamps and connects the temperature control component 3200 to the oxygenator body 1000, it can ensure that the temperature control component 3200 and the oxygenator body 1000 are aligned and coaxially arranged.

[0061] Referring to the accompanying drawings, the outer peripheral sidewall of the clamping transmission structure 2301 is designed with a circular profile. The clamping transmission structure 2301 is connected to the base 2100 via a bearing. Furthermore, the outer peripheral sidewall of the clamping transmission structure 2301 drives the clamping component 2200 to rotate through gear meshing. Specifically, the outer peripheral sidewall of the clamping transmission structure 2301 is provided with gear teeth, and correspondingly, the first end of the clamping component 2200 is provided with gear teeth. The gear teeth of the clamping component 2200 mesh with the gear teeth of the clamping transmission structure 2301, and the clamping transmission structure 2301 drives the clamping component 2200 to rotate through gear meshing.

[0062] Regarding the transmission between the clamping component 2200 and the clamping transmission structure 2301, an alternative design is provided: in some examples, a transmission gear is provided between the clamping component 2200 and the clamping transmission structure 2301. In some examples, the clamping component 2200 and the clamping transmission structure 2301 do not have gears, but are instead driven by a connecting rod, with the two ends of the connecting rod hinged to the clamping component 2200 and the clamping transmission structure 2301 respectively.

[0063] In one embodiment, the clamping assembly includes a clamping operation structure 2302 connected to a clamping transmission structure 2301, and the clamping operation structure 2302 extends out of the base 2100 so that the operator can hold and rotate the clamping operation structure 2302. Specifically, the operator drives the clamping transmission structure 2301 to rotate on the base 2100 via the clamping operation structure 2302, so that the clamping component 2200 connects to the oxygenator body 1000. It is understood that if the clamping transmission structure 2301 is rotated in the opposite direction by the clamping operation structure 2302, the clamping component 2200 can be released from clamping the oxygenator body 1000.

[0064] In one embodiment, the clamping assembly includes a locking operation structure 2401 and a locking connection structure 2402. The locking connection structure 2402 is fixedly disposed on the base 2100, and the locking operation structure 2401 is disposed on the clamping operation structure 2302. The locking operation structure 2401 can engage or disengage with the locking connection structure 2402. It is understood that when the clamping transmission structure 2301 is rotated to connect the clamping component 2200 to the oxygenator body 1000, the locking operation structure 2401 engages with the locking connection structure 2402 to fix the position of the rotation transmission structure, thereby fixing the clamping component 2200's gripping of the oxygenator body 1000.

[0065] Referring to the accompanying drawings, the locking connection structure 2402 is fixedly disposed on the upper side of the base 2100. Specifically, the locking connection structure 2402 is configured with a shape having an outer circumferential contour. The locking connection structure 2402 and the clamping transmission structure 2301 are both configured as annular structures, and the locking connection structure 2402 is located in the area enclosed by the clamping transmission structure 2301. In some examples, it can also be alternatively designed that the locking connection structure 2402 is integrally formed with the base 2100.

[0066] Furthermore, the locking operation structure 2401 is movably connected to the clamping operation structure 2302, so that the locking operation structure 2401 can engage or disengage from the locking connection structure 2402. Specifically, the locking operation structure 2401 is hinged to the clamping operation structure 2302. When the operator presses the first end of the locking operation structure 2401, the second end of the locking operation structure 2401 can be lifted, thereby disengaging the second end of the locking operation structure 2401 from the locking connection structure 2402.

[0067] To facilitate the engagement between the locking operation structure 2401 and the clamping transmission structure 2301, a locking elastic element is further designed at the hinge joint between the locking operation structure 2401 and the clamping operation structure 2302. This locking elastic element applies an elastic force to the locking operation structure 2401, allowing its second end to return to the position connected to the locking connection structure 2402. Specifically, the locking elastic element is a torsion spring, which is sleeved on the hinge shaft between the locking operation structure 2401 and the clamping operation structure 2302.

[0068] In some examples, the locking elastic element is replaced by a compression spring. Specifically, the two ends of the locking elastic element are respectively used to abut against the upper side of the clamping operation structure 2302 and the lower side of the first end of the locking operation structure 2401. When the first end of the locking operation structure 2401 is pressed, the locking elastic element has compressive potential energy. Further, the upper end of the locking elastic element is connected to the lower side of the first end of the locking operation structure 2401, or the lower end of the locking elastic element is connected to the upper side of the clamping operation structure 2302, or the two ends of the locking elastic element are respectively connected to the upper side of the clamping operation structure 2302 and the lower side of the first end of the locking operation structure 2401.

[0069] It should be noted that the locking operation structure 2401 is located within the clamping operation structure 2302. When the operator holds the clamping operation structure 2302, they can simultaneously press the locking operation structure 2401 to separate the locking operation structure 2401 from the locking connection structure 2402. After the clamping operation structure 2302 rotates and completes the assembly of the temperature control component 3200 and the oxygenator body 1000, the operator releases their hand. Under the action of the locking elastic element, the locking operation structure 2401 can automatically engage with the locking connection structure 2402, making the operation convenient.

[0070] In one implementation, the locking connection structure 2402 includes multiple locking connection areas for engaging the locking operation structure 2401. These locking connection areas are distributed circumferentially around the rotation axis of the clamping transmission structure 2301. It is understood that after the clamping transmission structure 2301 rotates and the clamping component 2200 clamps the oxygenator body 1000, the locking operation structure 2401 connects to the corresponding locking connection area, thereby locking and fixing the clamping transmission structure 2301.

[0071] Specifically, the locking connection area is recessed in the locking connection structure 2402. Referring to the attached drawings, the locking connection area is configured as a recessed hole, with multiple recessed holes spaced circumferentially on the upper side of the locking connection structure 2402. Further, the second end of the locking operation structure 2401 is provided with a locking connection end, which protrudes from the lower side of the second end of the locking operation structure 2401 and is inserted into the locking connection area. In some examples, the locking connection end is configured as a post.

[0072] Of course, the locking connection area can also be designed as follows.

[0073] In some examples, the locking connection area is recessed in the outer peripheral sidewall of the locking connection structure 2402, forming a groove. The upper end of the groove extends to the upper side of the locking connection structure 2402 to form an opening. It can be understood that when the second end of the locking operation structure 2401 is raised, it can move out of the locking connection area from the upper end of the groove.

[0074] In some examples, the locking connection area is set as a protruding structure on the upper side of the locking connection structure 2402. Specifically, the locking connection area is set as a protrusion or a post, and the first end of the locking operation structure 2401 is provided with a recessed area.

[0075] In some examples, the locking connection area is set as a protruding structure on the outer peripheral sidewall of the locking connection structure 2402.

[0076] This application relates to a temperature control component 3200, which has a heat exchange zone recessed within it. The heat exchange medium enters the heat exchange zone, completes heat exchange, and then exits. Specifically, the heat exchange zone includes an outer flow zone 3201 and an inner flow zone 3202. The outer flow zone 3201 is located near the outer peripheral sidewall of the temperature control component 3200, and the heat exchange medium exchanges heat with the blood in the oxygenation membrane fiber cavity 1203 within the outer flow zone 3201.

[0077] The heat exchange medium enters the outer flow zone 3201 from the first end of the heat exchange zone and conducts heat to the blood in the oxygenation membrane fiber cavity 1203 through the outer peripheral sidewall of the temperature control component 3200 to maintain the blood temperature. Further, the outer flow zone 3201 and the inner flow zone 3202 are connected at the second end of the heat exchange zone so that the heat exchange medium flows from the outer flow zone 3201 into the inner flow zone 3202, and then the heat exchange medium in the inner flow zone 3202 is discharged from the first end of the heat exchange zone. It can be understood that the flow direction of the heat exchange medium in the outer flow zone 3201 is from the first end to the second end, and the flow direction of the heat exchange medium in the inner flow zone 3202 is from the second end to the first end, and then it is discharged from the first end of the heat exchange zone.

[0078] In one implementation, the temperature control component 3200 includes a heat insulation layer 3203 disposed in the heat exchange zone, which is divided by the heat insulation layer 3203 to form an outer flow zone 3201 and an inner flow zone 3202. It is understood that the heat exchange medium flows on both sides of the heat insulation layer 3203, and the heat insulation layer 3203 can prevent heat transfer between the heat exchange medium in the inner flow zone 3202 and the outer flow zone 3201, thus avoiding affecting the heat exchange effect.

[0079] Furthermore, a gap is left between the end of the insulation layer 3203 and the second end of the heat exchange zone, so that the outer flow zone 3201 and the inner flow zone 3202 are connected at the second end of the heat exchange zone, forming a U-shaped flow path to realize the circulating flow of the heat exchange medium. Of course, it can also be designed as follows: the end of the insulation layer 3203 abuts against the second end of the heat exchange zone, and the sidewall of the insulation layer 3203 is provided with a connecting area near the second end of the heat exchange zone, the connecting area penetrating the sidewall of the insulation layer 3203.

[0080] Furthermore, considering that the heat generated during the operation of the driver 3100 needs to be dissipated, the driver 3100 is designed to allow heat conduction between itself and the temperature control component 3200. This allows the heat generated by the driver 3100 to be transferred to the heat exchange medium, thereby reducing the temperature of the driver 3100 and preventing burns. Specifically, the heat generated by the driver 3100 is transferred to the heat exchange medium in the inner flow area 3202.

[0081] In this case, the heat exchange medium at a set temperature T1 enters the outer circulation zone 3201 from the first end of the heat exchange zone. After the heat exchange medium completes heat exchange with the blood in the outer circulation zone 3201, the heat of the heat exchange medium is conducted to the blood in the oxygenation membrane fiber cavity 1203, the temperature of the heat exchange medium decreases, and the cooled heat exchange medium flows into the inner circulation zone 3202, which can absorb the heat of the driver 3100 and complete the cooling of the driver 3100. This achieves one cycle and two heat exchanges of the heat exchange medium, improves heat exchange efficiency, and reduces power consumption.

[0082] In some examples, a cylindrical cavity for housing the actuator 3100 is formed in the temperature control assembly 3200. The inner peripheral sidewall of the temperature control assembly 3200 abuts against the sidewall of the actuator 3100. The inner flow region 3202 is disposed close to the inner peripheral sidewall of the temperature control assembly 3200. The actuator 3100 conducts heat to the heat exchange medium in the inner flow region 3202 through the inner peripheral sidewall of the temperature control assembly 3200. It can be understood that by housing the actuator 3100 within the temperature control assembly 3200, forming an integrated structure, the structure is simplified and the structural integration of the oxygenator is improved.

[0083] In one embodiment, the temperature control assembly 3200 includes an inner ring structure 3204 and an outer ring structure 3205. The inner ring structure 3204 is disposed within the outer ring structure 3205. Specifically, the inner ring structure 3204 has an inner peripheral sidewall and an outer peripheral sidewall, and the outer ring structure 3205 also has an inner peripheral sidewall and an outer peripheral sidewall. Referring to the accompanying drawings, the inner ring structure 3204 is disposed within the cylindrical cavity formed by the inner peripheral sidewall of the outer ring structure 3205.

[0084] Furthermore, the outer ring structure 3205 is connected to the inner cylinder 1201. Referring to the attached drawings, the outer peripheral sidewall of the outer ring structure 3205 abuts against the inner peripheral sidewall of the inner cylinder 1201. Furthermore, the driver 3100 is connected to the inner ring structure 3204. The driver 3100 is disposed in the cylindrical cavity formed by the inner peripheral sidewall of the inner ring structure 3204, and the sidewall of the driver 3100 abuts against the inner peripheral sidewall of the inner ring structure 3204.

[0085] It is understood that the heat exchange zone is located between the inner ring structure 3204 and the outer ring structure 3205. Referring to the attached drawings, the heat exchange zone forms an opening at the first end of both the inner ring structure 3204 and the outer ring structure 3205, and the second ends of the inner ring structure 3204 and the outer ring structure 3205 are connected. In some examples, the inner ring structure 3204 and the outer ring structure 3205 are integrally formed; in other examples, the inner ring structure 3204 and the outer ring structure 3205 are formed separately.

[0086] In some examples, the insulation layer 3203 is configured as a ring structure, forming a cylindrical shape. It is understood that the insulation layer 3203 is disposed between the inner ring structure 3204 and the outer ring structure 3205.

[0087] In some examples, referring to the accompanying drawings, the outer peripheral sidewall of the inner ring structure 3204 is provided with a recessed area to form an inner flow area 3202. The inner flow area 3202 extends along the axial direction of the inner ring structure 3204, and at least two inner flow areas 3202 are provided at intervals along the circumference. The inner peripheral sidewall of the outer ring structure 3205 is provided with a recessed area to form an outer flow area 3201. The outer flow area 3201 extends along the axial direction of the outer ring structure 3205, and at least two outer flow areas 3201 are provided at intervals along the circumference.

[0088] Regarding the configuration of the heat exchange zone, as an alternative, it can also be designed as follows: In some examples, the annular cavity formed between the outer peripheral sidewall of the inner ring structure 3204 and the inner peripheral sidewall of the outer ring structure 3205 forms the heat exchange zone. In this case, the insulation layer 3203 is inserted into the heat exchange zone between the inner ring structure 3204 and the outer ring structure 3205. The annular cavity between the inner peripheral sidewall of the insulation layer 3203 and the outer peripheral sidewall of the inner ring structure 3204 forms the inner flow zone 3202, and the annular cavity between the outer peripheral sidewall of the insulation layer 3203 and the inner peripheral sidewall of the outer ring structure 3205 forms the outer flow zone 3201.

[0089] In one embodiment, the temperature control component 3200 includes a first end cap 3300, which is disposed at the first end of the temperature control component 3200. Further, the first end cap 3300 is provided with a water inlet 3301 and a water outlet 3302. The heat exchange medium enters from the water inlet 3301, which connects to the outer flow area 3201, and the water outlet 3302 connects to the inner flow area 3202. The heat exchange medium is discharged from the water outlet 3302.

[0090] Referring to the attached drawings, an inner annular groove 3303 and an outer annular groove 3304 are provided on one side of the first end cap 3300. It can be understood that the inner annular groove 3303 corresponds to the inner flow area 3202, and the outer annular groove 3304 corresponds to the outer flow area 3201. Specifically, the annular area of ​​the inner annular groove 3303 corresponds to the annular area of ​​the inner flow area 3202, and the outlet end 3302 is connected to the inner annular groove 3303. The annular area of ​​the outer annular groove 3304 corresponds to the annular area of ​​the outer flow area 3201, and the inlet end 3301 is connected to the outer annular groove 3304.

[0091] Furthermore, a partition 3305 is provided on the side wall of the first end cover 3300. The partition 3305 is configured as an annular structure, with an inner annular groove 3303 located on the inner side of the partition 3305 and an outer annular groove 3304 located on the outer side of the partition 3305. Referring to the attached drawings, the partition 3305 is connected to the heat insulation layer 3203. Specifically, a groove is provided at the end of the partition 3305, and the end of the heat insulation layer 3203 at the first end of the heat exchange zone is inserted into the groove.

[0092] In one implementation, the temperature control assembly 3200 includes a thermometer for detecting the temperature of the heat exchange medium. Specifically, a thermometer is provided in the outer flow area 3201 and an inner flow area 3202. Further, a recessed slot is provided on the inner peripheral sidewall of the outer ring structure 3205, and a recessed slot is provided on the outer peripheral sidewall of the inner ring structure 3204, with the thermometer disposed in the slot.

[0093] This application relates to an ECMO device, which includes an oxygenator and a constant-temperature water tank. The constant-temperature water tank supplies heat exchange medium to the outer circulation zone 3201, and the heat exchange medium in the inner circulation zone 3202 flows back to the constant-temperature water tank. The heat exchange medium treated by the constant-temperature water tank is then circulated back to the outer circulation zone 3201. Further, the constant-temperature water tank adjusts the returning heat exchange medium to a set temperature T1 to ensure that the temperature of the heat exchange medium supplied by the constant-temperature water tank to the outer circulation zone 3201 is T1.

[0094] Understandably, the outlet of the constant temperature water tank is connected to the inlet 3301 of the first end cover 3300 via a pipe, and the inlet of the constant temperature water tank is connected to the outlet 3302 of the first end cover 3300 via a pipe.

[0095] In some embodiments, the constant temperature water tank includes a heater and a radiator. It is understood that if the temperature of the heat exchange medium flowing back from the inner flow area 3202 to the constant temperature water tank is lower than T1, the heater is activated to heat the heat exchange medium to temperature T1. Correspondingly, if the temperature of the heat exchange medium flowing back from the inner flow area 3202 to the constant temperature water tank is higher than T1, the radiator is activated to lower the temperature of the heat exchange medium to T1.

[0096] Of course, as an alternative, the design could also include: in some examples, the thermostatic water tank includes a heater, which is suitable for scenarios where the driver 3100 generates less heat. In some examples, the thermostatic water tank includes a radiator, which is suitable for scenarios where the driver 3100 generates more heat.

[0097] The following describes the constant temperature control method of this application in detail with specific embodiments. It should be noted that the following description is only illustrative and not a specific limitation of this application.

[0098] This application relates to a constant temperature control method, which is implemented using an ECMO device, wherein the ECMO device includes a constant temperature water tank.

[0099] See Figure 3-1 A partial structural diagram of an ECMO device. The ECMO device includes a controller 4001, a heater 4002, a temperature sensor 4003, a constant temperature water tank 4004, a radiator 4005, and a water pump 4006. The heat exchange medium is configured according to... Figure 3-1 The flow direction is indicated by the arrow. Temperature sensor 4003 is used to detect the real-time temperature at the inlet of the constant temperature water tank, and the real-time temperature of the external flow area 3201 is also measured using a temperature sensor. The temperature sensor, heater, and radiator are all connected to the controller.

[0100] It should be noted that the radiator includes, but is not limited to, air-cooled heat sinks, and the heater includes, but is not limited to, electric heating elements.

[0101] The constant temperature control method includes the following steps.

[0102] S100 continuously acquires the first real-time temperature of the external circulation area and the second real-time temperature at the inlet of the constant temperature water tank.

[0103] It should be noted that the first and second real-time temperatures are always being monitored. If the temperature in the external circulation area or the inlet of the constant temperature water tank changes, the first or second real-time temperature will be promptly fed back to the controller, which will then receive and update the first or second real-time temperature.

[0104] S200: Compare the first real-time temperature with the second real-time temperature, and compare the first real-time temperature with the preset target temperature.

[0105] It should be noted that the target temperature is determined based on the actual application, and this embodiment does not impose specific limitations. The first real-time temperature is compared with the second real-time temperature, and the first real-time temperature is compared with the preset target temperature. Then, the control scheme of the controller is determined based on the comparison results.

[0106] S300: If the second real-time temperature is greater than the first real-time temperature, and the first real-time temperature is greater than the target temperature, control the radiator to start and increase the flow rate of the heat exchange medium until the first real-time temperature reaches the target temperature.

[0107] In one specific embodiment, see Figure 3-2 The target temperature is set to 35℃. The blood-side temperature sensor is used to detect the first real-time temperature of the external circulation area. If the first real-time temperature is 36℃, that is, the first real-time temperature is greater than the target temperature, the air-cooled heat sink (heat radiator) is activated and the flow rate of the heat exchange medium is increased until the first real-time temperature reaches the target temperature of 35℃.

[0108] S400: If the second real-time temperature is greater than the first real-time temperature and the first real-time temperature is less than the target temperature, control the radiator to close and increase the flow rate of the heat exchange medium. If the first real-time temperature does not reach the target temperature within a preset time, control the heater to turn on until the first real-time temperature reaches the target temperature.

[0109] It should be noted that the preset time is determined according to the actual application, and this embodiment does not impose specific restrictions. For example, the preset time is set to 10 seconds.

[0110] In one specific embodiment, see Figure 3-2 The target temperature is set to 35℃. The blood-side temperature sensor is used to detect the first real-time temperature of the external circulation area. If the first real-time temperature is 34℃, that is, the first real-time temperature is less than the target temperature, the air-cooled heat sink (radiator) is turned off and the flow rate of the heat exchange medium is increased. If the first real-time temperature reaches the target temperature of 35℃ within a preset time of 10 seconds, no other control is required. If the first real-time temperature does not reach the target temperature of 35℃ within a preset time of 10 seconds, the electric heating tube (heater) is turned on until the first real-time temperature reaches the target temperature of 35℃.

[0111] As one implementation method, the constant temperature control method also includes:

[0112] If the second real-time temperature is greater than the first real-time temperature before the first real-time temperature is adjusted to the target temperature;

[0113] After the first real-time temperature is adjusted to the target temperature, the radiator and heater are shut off, and the heat exchange medium is controlled to be at the first preset flow rate.

[0114] In one specific embodiment, see Figure 3-2 Before the first real-time temperature is adjusted to the target temperature, if the second real-time temperature is greater than the first real-time temperature, after the first real-time temperature is adjusted to the target temperature of 35°C, the electric heating tube (heater) and the air-cooled heat sink (radiator) are turned off, and the heat exchange medium is controlled to be at a low flow rate of the first preset flow rate so that the first real-time temperature is maintained within an effective range.

[0115] It should be noted that the first preset flow rate is determined according to the actual application, and this embodiment does not impose specific restrictions.

[0116] S500: If the second real-time temperature is lower than the first real-time temperature, and the first real-time temperature is higher than the target temperature, control the heater to shut down, the radiator to start, and increase the flow rate of the heat exchange medium until the first real-time temperature reaches the target temperature.

[0117] In one specific embodiment, see Figure 3-3 The target temperature is set to 35℃. The blood-side temperature sensor is used to detect the first real-time temperature of the external circulation area. If the first real-time temperature is 36℃, that is, the first real-time temperature is greater than the target temperature, the electric heating tube (heater) is turned off, the air-cooled heat sink (radiator) is turned on, and the flow rate of the heat exchange medium is increased until the first real-time temperature reaches the target temperature of 35℃.

[0118] S600. If the second real-time temperature is lower than the first real-time temperature, and the first real-time temperature is lower than the target temperature, control the heater to turn on and increase the flow rate of the heat exchange medium until the first real-time temperature reaches the target temperature.

[0119] In one specific embodiment, see Figure 3-3 The target temperature is set to 35℃. The blood-side temperature sensor is used to detect the first real-time temperature of the external circulation area. If the first real-time temperature is 34℃, that is, the first real-time temperature is less than the target temperature, the electric heating tube (heater) is turned on and the flow rate of the heat exchange medium is increased until the first real-time temperature reaches the target temperature of 35℃.

[0120] As one implementation method, the constant temperature control method also includes:

[0121] If the second real-time temperature is lower than the first real-time temperature before the first real-time temperature is adjusted to the target temperature;

[0122] After the first real-time temperature is adjusted to the target temperature, the heater is controlled to be in a constant temperature state, and the heat exchange medium is controlled to be at the second preset flow rate.

[0123] In one specific embodiment, see Figure 3-3 Before the first real-time temperature is adjusted to the target temperature, if the second real-time temperature is lower than the first real-time temperature, after the first real-time temperature is adjusted to the target temperature of 35°C, the electric heating tube (heater) is controlled to be in a constant temperature state, and the heat exchange medium is controlled to be at the second preset flow rate, so that the first real-time temperature is maintained within an effective range.

[0124] It should be noted that the second preset flow rate is determined according to the actual application, and this embodiment does not impose specific restrictions.

[0125] As one implementation method, the constant temperature control method also includes:

[0126] S700: If the first real-time temperature is greater than the preset temperature threshold range, an alarm signal is output; the temperature threshold range is determined based on the target temperature and error tolerance.

[0127] It should be noted that the error tolerance is determined based on the actual application, and this embodiment does not impose specific limitations. For example, the error tolerance is set to 3℃. The temperature threshold range is determined based on the target temperature plus / minus the error tolerance. For example, if the target temperature is 35℃, the error tolerance is 3℃, and the temperature threshold range is 32℃-38℃.

[0128] See Figure 3-2 and Figure 3-3 If the first real-time temperature is greater than the preset temperature threshold range of 32℃-38℃, an alarm signal will be output and manual intervention will be required.

[0129] In the description of this specification, the use of terms such as "an embodiment," "some examples," "some embodiments," "illustrative embodiment," "example," "specific example," or "some examples" indicates that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of this application. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0130] The embodiments of this application have been described in detail above with reference to the accompanying drawings. However, this application is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of this application.

[0131] In the description of this application, the presence of a comma ("、") in the patent title indicates an "and" relationship, not an "or" relationship. For example, if the patent title is "A and B", it means that the content claimed in this application is: a technical solution with the subject matter title A and a technical solution with the subject matter title B.

Claims

1. A temperature control component, characterized in that: The temperature control component (3200) is disposed in the oxygenator. The temperature control component (3200) forms a recessed heat exchange zone, which includes an outer flow zone (3201) and an inner flow zone (3202). The heat exchange medium enters the outer flow zone (3201) from the first end of the heat exchange zone and conducts heat to the blood in the oxygenation membrane fiber cavity (1203) of the oxygenator through the outer peripheral sidewall of the temperature control component (3200). The outer flow zone (3201) and the inner flow zone (3202) are connected at the second end of the heat exchange zone so that the heat exchange medium enters the inner flow zone (3202) from the outer flow zone (3201). The heat exchange medium in the inner flow zone (3202) is discharged from the first end of the heat exchange zone. The temperature control component (3200) is capable of heat exchange with the actuator (3100) in the oxygenator, and the heat exchange medium in the inner flow zone (3202) absorbs the heat from the actuator (3100). The temperature control component (3200) includes an inner ring structure (3204) and an outer ring structure (3205). The inner ring structure (3204) has an inner peripheral sidewall and an outer peripheral sidewall. The actuator (3100) is disposed in the cylindrical cavity formed by the inner peripheral sidewall of the inner ring structure (3204). The outer ring structure (3205) has an inner peripheral sidewall and an outer peripheral sidewall. The inner ring structure (3204) is disposed in the cylindrical cavity formed by the inner peripheral sidewall of the outer ring structure (3205). The heat exchange zone is disposed between the inner ring structure (3204) and the outer ring structure (3205).

2. The temperature control component according to claim 1, characterized in that: The temperature control component (3200) includes a heat insulation layer (3203), which is disposed in the heat exchange zone. The heat exchange zone is separated by the heat insulation layer (3203) to form the outer flow zone (3201) and the inner flow zone (3202).

3. The temperature control component according to claim 2, characterized in that: A gap is left between the end of the insulation layer (3203) and the second end in the heat exchange zone so that the outer flow zone (3201) and the inner flow zone (3202) are connected at the second end of the heat exchange zone.

4. The temperature control component according to claim 2 or 3, characterized in that: The temperature control assembly (3200) has a cylindrical cavity formed for setting the driver (3100).

5. The temperature control component according to claim 2 or 3, characterized in that: The heat insulation layer (3203) is configured as a ring structure, and the heat insulation layer (3203) is disposed between the inner ring structure (3204) and the outer ring structure (3205).

6. The temperature control component according to claim 2 or 3, characterized in that: The inner ring structure (3204) has a recessed area on its outer peripheral sidewall to form the inner flow area (3202), and at least two inner flow areas (3202) are provided at intervals along the circumference. The outer ring structure (3205) has a recessed area on its inner peripheral sidewall to form the outer flow area (3201), and at least two outer flow areas (3201) are provided at intervals along the circumference.

7. The temperature control component according to claim 6, characterized in that: The inner flow area (3202) is configured as a cylindrical cavity on the outer peripheral sidewall of the inner ring structure (3204), and the outer flow area (3201) is configured as a cylindrical cavity on the inner peripheral sidewall of the outer ring structure (3205).

8. The temperature control component according to claim 5, characterized in that: The heat exchange zone is configured as an annular cavity formed between the outer peripheral sidewall of the inner ring structure (3204) and the inner peripheral sidewall of the outer ring structure (3205), and the heat insulation layer (3203) is inserted into the annular cavity to divide the annular cavity into the inner flow zone (3202) and the outer flow zone (3201).

9. The temperature control component according to claim 1, characterized in that: The temperature control component (3200) includes a first end cap (3300), which is disposed at the first end of the temperature control component (3200). The first end cap (3300) is provided with a water inlet (3301) and a water outlet (3302). The water inlet (3301) is connected to the external flow area (3201), and the water outlet (3302) is connected to the internal flow area (3202).

10. The temperature control component according to claim 9, characterized in that: The first end cap (3300) has an inner ring groove (3303) and an outer ring groove (3304) on one side. The inner ring groove (3303) corresponds to the inner flow area (3202), and the outer ring groove (3304) corresponds to the outer flow area (3201).

11. An oxygenator, characterized in that: include The oxygenator body (1000) includes an inner cylinder (1201) and an outer cylinder (1202). The inner cylinder (1201) is disposed in the outer cylinder (1202), and the area between the inner cylinder (1201) and the outer cylinder (1202) forms an oxygenation membrane fiber cavity (1203). The temperature control component (3200) as described in any one of claims 1 to 10 is disposed in the cylindrical cavity enclosed by the inner cylinder (1201), and the temperature control component (3200) is in contact with the inner cylinder (1201) for heat conduction.

12. The oxygenator according to claim 11, characterized in that: The oxygenator includes a driver (3100) and a blood pump rotor (1100), the blood pump rotor (1100) being disposed in the oxygenator body (1000), the driver (3100) being used to drive the blood pump rotor (1100) to rotate, and the driver (3100) being disposed in the temperature control assembly (3200).

13. The oxygenator according to claim 11 or 12, characterized in that: The temperature control component (3200) is detachably disposed in the cylindrical cavity enclosed by the inner cylinder (1201).

14. An ECMO device, characterized in that: include The oxygenator as claimed in any one of claims 11 to 13; A constant temperature water tank supplies heat exchange medium to the outer circulation zone (3201), and the heat exchange medium in the inner circulation zone (3202) flows back to the constant temperature water tank. The constant temperature water tank adjusts the returned heat exchange medium to a set temperature.

15. The ECMO device according to claim 14, characterized in that: The constant temperature water tank includes a heater and / or a radiator.

16. The ECMO device according to any one of claims 14 to 15, characterized in that, It can implement the following constant temperature control methods: Continuously acquire the first real-time temperature of the external circulation area and the second real-time temperature at the inlet of the constant temperature water tank; The first real-time temperature is compared with the second real-time temperature, and the first real-time temperature is compared with the preset target temperature. If the second real-time temperature is greater than the first real-time temperature, and the first real-time temperature is greater than the target temperature, the radiator is activated and the flow rate of the heat exchange medium is increased until the first real-time temperature reaches the target temperature. If the second real-time temperature is greater than the first real-time temperature and the first real-time temperature is less than the target temperature, the radiator is controlled to close and the flow rate of the heat exchange medium is increased. If the first real-time temperature does not reach the target temperature within a preset time, the heater is controlled to turn on until the first real-time temperature reaches the target temperature. If the second real-time temperature is lower than the first real-time temperature, and the first real-time temperature is higher than the target temperature, control the heater to turn off, the radiator to start, and increase the flow rate of the heat exchange medium until the first real-time temperature reaches the target temperature. If the second real-time temperature is lower than the first real-time temperature, and the first real-time temperature is lower than the target temperature, the heater is turned on and the flow rate of the heat exchange medium is increased until the first real-time temperature reaches the target temperature.

17. The ECMO device according to claim 16, characterized in that, The temperature control methods implemented also include: If the second real-time temperature is greater than the first real-time temperature before the first real-time temperature is adjusted to the target temperature; After the first real-time temperature is adjusted to the target temperature, the radiator and the heater are turned off, and the heat exchange medium is controlled to be at the first preset flow rate.

18. The ECMO device according to claim 16, characterized in that, The temperature control methods implemented also include: If the second real-time temperature is lower than the first real-time temperature before the first real-time temperature is adjusted to the target temperature; After the first real-time temperature is adjusted to the target temperature, the heater is controlled to be in a constant temperature state, and the heat exchange medium is controlled to be at a second preset flow rate.

19. The ECMO device according to claim 16, characterized in that, The temperature control methods implemented also include: If the first real-time temperature is greater than the preset temperature threshold range, an alarm signal is output; the temperature threshold range is determined based on the target temperature and the error tolerance.

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