CN117426854A

CN117426854A - Refrigerating device, cryoablation system and method

Info

Publication number: CN117426854A
Application number: CN202210826944.9A
Authority: CN
Inventors: 庞德贵; 沈刘娉; 王浩松; 许元兴; 陈春英
Original assignee: Shanghai Microport EP MedTech Co Ltd
Current assignee: Shanghai Microport EP MedTech Co Ltd
Priority date: 2022-07-14
Filing date: 2022-07-14
Publication date: 2024-01-23
Also published as: WO2024012510A1

Abstract

The application relates to a refrigeration device, a cryoablation system and a method, comprising: a refrigerating unit; the Stirling cold head is connected with the refrigerating unit; the fixed part is connected with the cooling surface of the Stirling cold head; and the cooling pipe is arranged on the fixing part and used for cooling the refrigerant used for cryoablation, and the Stirling cold head is used for cooling the cooling pipe arranged on the fixing part through the cooling surface. The utility model provides a can carry out the accurate control to the actual temperature of refrigerant for the temperature of refrigerant is in the safe ablation scope of predetermineeing, not only can prevent that the cooling tube from appearing blockking up, makes the temperature of ablation in-process cryoablation sacculus better at the cooling rate that patient's position provided, guarantees that the doctor can be better, safer completion operation, can also reduce the air inlet pressure of cryoablation sacculus, prevents that cryoablation sacculus from warping and bringing the damage for the tissue.

Description

Refrigerating device, cryoablation system and method

Technical Field

The application belongs to the technical field of medical instruments, and particularly relates to a refrigerating device, a cryoablation system and a method.

Background

Cryoablation has received much attention in recent years as a new modality for treating atrial fibrillation. The working principle is that the heat of the tissue is taken away through the endothermic evaporation of the liquid refrigerant, so that the temperature of the target ablation part is reduced, and the cell tissue is frozen down, thereby damaging the region with abnormal electrophysiological activity and achieving the aim of treating arrhythmia. A large amount of clinical data show that compared with other ablation modes, cryoablation is easier for doctors to learn and operate, shortens the operation time, has high treatment effectiveness, reduces serious complications such as thrombus and the like, and reduces the pain degree of patients.

However, in the conventional cryoablation system, the ablation is controlled by a fixed flow in the ablation stabilization process, the longer the ablation time is, the lower the temperature is, and the lower the temperature cannot be kept, in order to prevent risks, the ablation can only be stopped, the next ablation process circulation operation can be performed after the temperature is recovered, so that the operation difficulty is increased, the operation time is prolonged, the risk in the operation process is increased, the isolation effect of the pulmonary veins is poor, and the side effect of the operation on tissues is large. With the increase of the number of cryoablation operations, the demand market has more demands on the low-temperature control in the cryosurgery, and how to maintain the balloon temperature in the cryoablation process within the demand range becomes a problem to be solved urgently.

Disclosure of Invention

In view of the foregoing, it is desirable to provide a refrigerating device, a cryoablation system, and a method capable of controlling the temperature in the cryoablation balloon within a preset safe ablation range and avoiding damage to the tissue caused by deformation of the cryoablation balloon.

A first aspect of the present application provides a refrigeration device, including a refrigeration unit, a stirling cold head, a fixing component, and a cooling tube, the stirling cold head being connected to the refrigeration unit; the fixed part is connected with the cooling surface of the Stirling cold head; the cooling tube is arranged on the fixing part and used for cooling the refrigerant used for cryoablation, and the Stirling cold head is used for cooling the cooling tube arranged on the fixing part through the cooling surface. The Stirling cold head is used for a cryoablation system, and the Stirling cold head is used for transmitting energy, so that the cooling rate of ablation is improved, and meanwhile, the air inlet pressure of a cooling tube is reduced, and therefore the efficiency and the safety of an operation are improved.

In one embodiment, the fixing component comprises a coil fixing piece, and the side wall of the coil fixing piece is provided with an annular pipeline groove for accommodating the cooling pipe; the sleeve of coil pipe mounting locates the Stirling cold head for the cooling tube in the pipeline recess realizes heat transfer with the cooling surface.

In one embodiment, the cooling tube is welded into the tube recess by a vacuum welding process. The cooling tube is embedded in the pipeline recess on coil pipe mounting lateral wall to weld into a whole with the pipeline recess through vacuum welding technology, compare with the cryoablation system in the past, refrigerating plant in this application has improved the integrated level of coil pipe mounting, and the cooling tube can more direct utilization Stirling cold head's energy, and the cooling tube can more abundant absorption to refrigerating unit passes through Stirling cold head's cooling surface transmission energy.

In one embodiment, the refrigeration unit further comprises a bottom plate connected to an end face of the coil mount remote from the refrigeration unit; the refrigerating device further comprises a temperature detection component, wherein the temperature detection component is arranged on the surface, far away from the refrigerating unit, of the bottom plate and is used for detecting a real-time temperature value.

In one embodiment, the refrigeration device further comprises a heating assembly and a controller disposed on a surface of the base plate remote from the refrigeration unit; the controller is electrically connected with the temperature detection component and the heating component and is used for controlling the heating component to heat under the condition that the real-time temperature value is lower than a preset phase change threshold value, so that the real-time temperature value is positioned in a preset safe ablation range. The controller can obtain the real-time temperature value of the cooling tube on the coil pipe fixing part through the temperature detection part, namely, the real-time temperature value of the approximate refrigerant, and when the real-time temperature value is lower than a preset phase change threshold value, the heating assembly is controlled to heat the coil pipe fixing part so as to achieve the purpose of heating the refrigerant in the cooling tube, so that the actual temperature of the refrigerant can be kept in a preset safe ablation range.

In one embodiment, the heating assembly comprises an electrical heater strip attached to the base plate or the coil mount. The electric heating plate occupies a large area, and can be used for heating coil fixing pieces more comprehensively and rapidly.

In one embodiment, the electric heating plate is X-shaped to form a plurality of clamping grooves; the bottom plate is provided with screw holes, and the screw holes are uniformly distributed in the clamping grooves, so that the damage to the heating wires in the electric heating plates caused by bolts arranged in the screw holes is avoided.

In one embodiment, the fixing member includes: and the heat conduction fastener is sleeved at one end of the Stirling cold head, which is far away from the refrigerating unit, and is used for connecting the coil fixing piece with the Stirling cold head and carrying out heat transfer.

In one embodiment, the refrigerating device further comprises a temperature detection component, the temperature detection component is arranged on the surface, far away from the refrigerating unit, of the bottom plate and is used for detecting a real-time temperature value, and the temperature detection component comprises a thermocouple, and the thermocouple is arranged on the surface, far away from the heat conducting fastening piece, of the bottom plate. The thermocouple arranged on the surface of the bottom plate far away from the heat conduction fastener can realize real-time temperature detection of the cooling pipe arranged on the coil pipe fixing piece, and the actual effect of the refrigerating device for refrigerating the refrigerant in the cooling pipe can be visually observed through the thermocouple. The coil pipe fixing piece is sleeved on the heat conduction fastening piece, so that the occupied volume of each part of the refrigerating device after being combined is smaller, the integration degree is higher, and the assembled refrigerating device is more attractive.

In one embodiment, screw holes are formed in the contact end surfaces of the heat conduction fasteners and the bottom plate, and the coil fixing piece is connected with the heat conduction fasteners through bolts arranged in the screw holes. Bolts sequentially penetrate through screw holes in the bottom plate and the heat conduction fasteners, the bottom plate, the coil fixing pieces and the heat conduction fasteners are connected into a firm whole, and the firmness of the assembled refrigerating device is improved. The thermocouple is wound on the stud of the bolt, so that when the bolt is in threaded connection with the screw hole, the head of the bolt presses the thermocouple, and the thermocouple is fixed on the surface of the bottom plate far away from the heat conducting fastener. The mode that the bolt head pushed down the thermocouple can prevent that the thermocouple from falling off from coil pipe mounting because of vibration in the in-service use.

In one embodiment, the heat conductive fastener comprises a barrel-shaped body with an adjustable inner diameter and a through hole matched with the cooling surface, and the heat conductive fastener is used for encircling and fixing one end of the Stirling cold head far away from the refrigeration unit, so that the cooling pipe in the pipeline groove is contacted with the cooling surface through the through hole. The barrel-shaped body can correspondingly adjust the inner diameter according to the size of the Stirling cold head, so that the cooling surface of the Stirling cold head can be fully wrapped by the barrel-shaped body, the cooling surface of the Stirling cold head can be in seamless contact with the barrel-shaped body, the loss in the energy transfer process is reduced, the refrigeration efficiency of a refrigeration unit is improved, simultaneously, stirling cold heads of different models can be fastened with coil pipe fixing pieces of the same size, and the suitability of products is improved.

In one embodiment, the refrigeration device further comprises a thermally conductive layer disposed between the coil mount and the mating surface of the barrel body. The heat conducting layer can fill gaps between the coil fixing piece and the barreled body, so that loss in the temperature transmission process is reduced.

In one embodiment, the thermally conductive layer comprises a thermally conductive silicone grease uniformly applied between mating surfaces of the coil mount and the barrel body. The heat conduction silicone grease has good heat conduction performance, and can reduce the loss in the temperature transmission process.

In one embodiment, the refrigeration device further comprises an interaction unit, wherein the interaction unit is electrically connected with the controller and is used for displaying the real-time temperature value; and/or acquiring a preset safe ablation range set by a user. The user can obtain the real-time temperature value detected by the temperature detecting part 600 through the interaction unit and set the preset safe ablation range through the interaction unit 900, so that the interactivity between the refrigerating device and the user is improved.

In one embodiment, the predetermined safe ablation range is [ -80 ℃, -50 ℃). When the controller controls the real-time temperature value to be in a preset safe ablation range of-80 ℃ and-50 ℃, the temperature of the center of the balloon in the ablation process can be enabled to provide a better cooling rate at the patient position, and the cooling tube is not blocked.

In one embodiment, a controller is electrically connected to the refrigeration unit, the controller configured to: in the initial stage of refrigeration, controlling the refrigeration unit to quickly cool at a preset full-load power; and controlling the temperature detection component to detect the real-time temperature value of the coil pipe fixing piece from any moment in the first preset time before cryoablation to the end of cryoablation, and controlling the real-time temperature value to be in a preset safe ablation range by adopting a proportional-integral-derivative algorithm. In actual operation, the refrigerating device starts to refrigerate and then possibly needs to stand by for different time to start operation, at this moment, the refrigerating device needs to keep full-load refrigerating power to ensure that when starting to ablate, the refrigerating unit can cool down the refrigerant rapidly, but because the refrigerant can change phase at low temperature, thereby the cooling tube is blocked by the solid state of gas/liquid state, therefore the controller controls the temperature detection component to detect the real-time temperature value of the coil fixing piece, when the real-time temperature value is lower than the preset phase change threshold value, the heating component is controlled to heat, the real-time temperature value is positioned in the preset safe ablation range, and through the arrangement, the cooling tube is prevented from being blocked while the refrigerant is kept at low temperature.

A second aspect of the present application provides a cryoablation system comprising a cryoablation balloon catheter and a refrigeration device according to any of the embodiments of the present application, the cryoablation balloon catheter comprising a cryoablation balloon for effecting heat transfer between a refrigerant flowing through the cryoablation balloon and the environment, the outlet of the cooling tube being disposed within the cryoablation balloon. The refrigeration device is used for replacing the traditional refrigeration device, and comprises a refrigeration unit, a Stirling cold head, a coil pipe fixing piece, a cooling pipe, a heat conduction fastening piece, a temperature detection part, a heating component, a controller and an interaction unit, wherein the refrigeration unit is used for refrigerating, and the Stirling cold head is connected with the refrigeration unit; the coil pipe fixing piece is connected with the cooling surface of the Stirling cold head and used for cooling a cooling pipe arranged on the coil pipe fixing piece through the cooling surface, the side wall of the coil pipe fixing piece is provided with an annular pipeline groove, and the pipeline groove is used for accommodating the cooling pipe; the bottom plate is connected with the end face of the coil pipe fixing piece, which is far away from the refrigerating unit, and is used for forming a containing cavity for coating the heat conduction fastening piece. The heat conduction fastener cover is located the one end that refrigeration unit was kept away from to the Stirling cold head for connect coil pipe mounting and Stirling cold head and carry out heat transfer, heat conduction fastener includes the tubbiness body, and the internal diameter of tubbiness body is adjustable and the surface of cooperation cooling surface includes the through-hole, is used for encircling to be fixed in the one end that refrigeration unit was kept away from to the Stirling cold head, makes the interior cooling tube of pipeline recess pass through the through-hole and the cooling surface contact. The temperature detection component is arranged on the surface of the bottom plate far away from the heat conduction fastener and is used for detecting a real-time temperature value; the heating component is arranged on the surface of the bottom plate far away from the heat conduction fastener; the controller is electrically connected with the temperature detection component and the heating component and is used for controlling the heating component to heat under the condition that the real-time temperature value is lower than a preset phase change threshold value, so that the real-time temperature value is positioned in a preset safe ablation range; the controller is also electrically connected to the refrigeration unit, and the controller may be configured to: in the initial stage of refrigeration, controlling the refrigeration unit to quickly cool at a preset full-load power; and controlling the temperature detection component to detect the real-time temperature value of the coil pipe fixing piece from any moment in the first preset time before cryoablation to the end of cryoablation, and controlling the real-time temperature value to be in a preset safe ablation range by adopting a proportional-integral-derivative algorithm. In the cryoablation system, the controller in the refrigeration device can acquire the real-time temperature value of the bottom plate through the temperature detection component, namely, the real-time temperature value of the approximate refrigerant, and when the real-time temperature value is lower than the preset phase change threshold value of the refrigerant, the heating component is controlled to heat the bottom plate so as to achieve the purpose of heating the refrigerant, so that the actual temperature of the refrigerant can be kept within the preset safe ablation range. Further, the controller can also control the refrigerating unit to quickly cool down at the initial stage of refrigeration with the preset full load power so as to ensure that the refrigerating unit can quickly cool down the refrigerant when the ablation starts, thereby providing the best temperature state for the operation, and the controller controls the temperature detection component to detect the real-time temperature value of the coil pipe fixing piece in the period from any moment in the first preset time before the cryoablation to the end of the cryoablation, and controls the heating component to heat when the real-time temperature value is lower than the preset phase change threshold value, so that the real-time temperature value is positioned in the preset safe ablation range.

A third aspect of the present application provides a cryoablation temperature control method for cooling a refrigerant for cryoablation, the method comprising: the control refrigeration unit cools down a cooling pipe on a coil fixing piece through the Stirling cold head, and the coil fixing piece is connected with a cooling surface of the Stirling cold head; and acquiring a real-time temperature value of the cooling pipe, and controlling the heating assembly to heat under the condition that the real-time temperature value is lower than a preset phase change threshold value, so that the real-time temperature value is positioned in a preset safe ablation range, and the heating assembly is arranged on the coil pipe fixing piece.

In one embodiment, the method further comprises: in the initial stage of refrigeration, controlling the refrigeration unit to quickly cool at a preset full-load power; and controlling the temperature detection part to detect the real-time temperature value of the coil pipe fixing piece from any moment in a first preset time before cryoablation to the end of cryoablation, and controlling the real-time temperature value to be in a preset safe ablation range by adopting a proportional-integral-derivative algorithm.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the description of the embodiments will be briefly introduced below, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other embodiments of the drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

Fig. 1 is a schematic diagram of an assembled refrigeration device according to an embodiment of the present application.

Fig. 2 shows an exploded view of the structure of the refrigeration device in one embodiment of the present application.

Fig. 3 shows a schematic view of the coil holder, base plate and heating assembly of the refrigeration unit of one embodiment of the present application.

Fig. 4 is a schematic structural view of a heat-conducting fastener in a refrigeration device according to an embodiment of the present application.

Fig. 5 shows a schematic structural view of a coil holder, a temperature detecting member and a heating assembly in a refrigeration apparatus according to an embodiment of the present application.

Fig. 6 is a schematic block diagram showing a controller in a refrigeration apparatus according to an embodiment of the present application.

Fig. 7 is a schematic block diagram showing a controller in a refrigeration apparatus according to another embodiment of the present application.

Fig. 8 is a schematic block diagram showing a controller in a refrigeration apparatus according to still another embodiment of the present application.

Fig. 9 is a schematic electrical structure of a controller in a refrigeration apparatus according to an embodiment of the present application.

Fig. 10 is a schematic diagram of a PID control in an embodiment of the present application.

Fig. 11 is a schematic structural view of a cryoablation system in one embodiment of the present application.

Fig. 12 is a flow chart of a cryoablation temperature control method in one embodiment of the present application.

Fig. 13 is a graph showing the temperature versus time of a cryoablation balloon when the temperature of the cryoablation balloon is controlled to decrease by using the refrigeration device in one embodiment of the present application and a conventional refrigeration device using a conventional compressor with a working medium R134 a.

Fig. 14 is a graph showing the relationship between the intake pressure and time of the cryoablation balloon when the temperature of the cryoablation balloon is controlled to be reduced to the same temperature by using the refrigeration device in one embodiment of the present application and the conventional refrigeration device using a common compressor with a working medium R134 a.

Detailed Description

In order to facilitate an understanding of the present application, a more complete description of the present application will now be provided with reference to the relevant figures. Preferred embodiments of the present application are shown in the drawings. This application may, however, be embodied in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein in the description of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The term "and/or" as used herein includes any and all combinations of one or more of the associated listed items.

Where the terms "comprising," "having," and "including" are used herein, another component may also be added unless explicitly defined as such, e.g., "consisting of … …," etc. Unless mentioned to the contrary, singular terms may include plural and are not to be construed as being one in number.

It will be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or be connected to the other element through intervening elements. Furthermore, "connected" in the following embodiments, if there is a transfer of electrical signals or data between the objects being connected, is understood to be "electrically connected", "communication connected", etc., and the description herein of "remote" is merely for the purpose of describing the relative positional characteristics, and does not mean a substantial distance size, for example "the end face of the base plate and the coil fixture remote from the refrigeration unit" means that the coil fixture has two opposite end faces, one of which is farther from the refrigeration unit than the other end face, and the base plate is disposed on this end face.

The traditional refrigeration device contained in the existing cryoablation system often cannot effectively control the temperature of the cryoablation balloon, and the cooling speed and the safety are not well controlled.

The application aims at providing a refrigerating device which can realize the accurate control of the temperature of the refrigerant in a cryoablation system and further improve the safety.

As shown in fig. 1, in one embodiment of the present application, there is provided a refrigeration device for cooling a cooling tube that delivers a refrigerant to a cryoablation balloon, the refrigeration device comprising: the refrigeration unit 100, the Stirling cold head 200, the fixing component and the cooling pipe 400, wherein the refrigeration unit 100 is used for refrigeration, and the Stirling cold head 200 is connected with the refrigeration unit 100; in the present embodiment, the fixing member includes a coil fixing member 300, and the coil fixing member 300 is connected to the cooling surface of the Stirling cold head 200, and the Stirling cold head 200 performs heat transfer via the cooling surface and the cooling tube 400 provided on the coil fixing member 300.

Specifically, the cooling tube 400 is used for connecting a cryoablation system, the inlet of the cooling tube 400 receives a gaseous, liquid or gas-liquid two-phase refrigerant, and the refrigerant is fully liquefied by the refrigeration function of the refrigeration unit 100 after passing through the cooling tube 400, and the outlet of the cooling tube 400 outputs a low-temperature liquid refrigerant to the patient.

Illustratively, the refrigeration unit 100 is a refrigerator coupled to the Stirling cold head 200.

By way of example, the coil mount 300 may be a retaining ring, a retaining bracket, or the like.

As an example, a stirling cooler is used for cooling and refrigerating, one end of the stirling cooler 200 is fixedly arranged on the stirling cooler, the cooling surface of the stirling cooler 200 is the outer surface of the stirling cooler 200, the cooling surface of the stirling cooler 200 is connected with a coil fixing member 300, a cooling tube 400 is arranged on the coil fixing member 300, and the cooling surface of the stirling cooler 200 is in temperature exchange with the cooling tube 400 through the arrangement, so that the purpose of reducing the temperature of the refrigerant flowing through the cooling tube 400 is achieved.

At present, in the refrigeration mode, the conventional refrigeration mode is basically selected by a common compressor, the common compressor is commonly used in household appliances such as air conditioners, refrigerators and the like, and has the advantages of low price, mature refrigeration technology and the like, but in the field of refrigeration ablation medical treatment, the cooling rate is required to be faster, the common compression can not fully convert the refrigerant into the liquid state under a certain flow, and the refrigerant can be converted into the liquid state only by being improved to a higher pressure according to a pressure enthalpy diagram. From the aspect of surgery treatment, the temperature of the refrigerant needs to be lower in a shorter time (the lower the temperature of the tissue is in the first tens of seconds, the better the effect of cooling is), and the common compressor can not meet the higher requirements on refrigeration by combining with a cryoablation pipeline.

Therefore, in the embodiment, the Stirling cold head is used for a cryoablation system, and the Stirling cold head is used for transmitting energy, so that the cooling rate of ablation is improved, and the air inlet pressure of the cooling tube is reduced, and the efficiency and the safety of an operation are improved.

As shown in fig. 1 and 3, in one embodiment of the present application, the side wall of the coil holder 300 is provided with an annular pipe groove 311, and the pipe groove 311 is used for accommodating the cooling pipe 400; the coil fixing member 300 is sleeved on one end of the Stirling cold head 200 away from the refrigeration unit 100, so that heat transfer is realized between the cooling tube 400 in the pipeline groove 311 and the cooling surface.

Specifically, the coil fixing member 300 is sleeved at one end of the stirling cooler 200 away from the refrigeration unit 100, the outer side wall of the coil fixing member 300 is recessed inwards to form an annular pipeline groove 311, the cooling tube 400 is wound in the pipeline groove 311 and is connected with the bottom of the pipeline groove 311, the bottom of the pipeline groove 311 is spaced between the cooling tube 400 and the cooling surface of the stirling cooler 200, the refrigerant flowing in the cooling tube 400 and the cooling surface of the stirling cooler 200 exchange heat indirectly through the bottom of the pipeline groove 311, in another possible embodiment, the coil fixing member 300 comprises two annular bodies, the first annular body, the cooling tube 400 and the second annular body are sequentially connected into a whole in a welding mode, at this time, the refrigerant flowing in the cooling tube 400 and the cooling surface of the stirling cooler 200 can directly exchange heat, and the refrigeration unit 100 directly cools the cooling tube arranged in the pipeline groove 311 through the cooling surface of the stirling cooler 200.

Specifically, the cooling tube 400 is welded into the pipe groove 311 by a vacuum welding process to ensure a seamless connection of the cooling tube 400 and the coil holder 300.

In the present embodiment, the cooling tube 400 is embedded in the pipe groove 311 on the side wall of the coil fixing member 300 and is welded with the pipe groove 311 into a whole through a vacuum welding process, so that the integration of the coil fixing member 300 is improved, and by this arrangement, the cooling tube 400 can more directly utilize the energy of the Stirling cold head 200, and the cooling tube 400 can more sufficiently absorb the energy transferred from the refrigerating unit 100 through the cooling surface of the Stirling cold head 200.

As shown in fig. 1 and 4, in one embodiment of the present application, the fixing member further includes a heat conductive fastener 500, and the heat conductive fastener 500 is sleeved on the end of the stirling cooler head 200 away from the refrigeration unit 100, for connecting the coil fixing member 300 and the stirling cooler head 200 and conducting temperature.

Specifically, the heat conductive fastener 500 is made of a material with high transmission performance, such as copper.

Considering that the coil fixing member provided with the cooling tube is directly connected to the cold head of the cooling unit, in the actual use process, due to vibration of the cooling unit 100 during the cooling operation, the coil fixing member directly connected to the cold head may be loosened, which may cause the cooling device to malfunction, further make the cryoablation system unable to cool normally, and seriously cause operation failure of doctors.

Therefore, in the present embodiment, the heat-conducting fastener 500 is used to connect the coil fixing member 300 and the stirling cooler 200, so that the connection between the coil fixing member 300 and the stirling cooler 200 is more secure, and the coil fixing member 300 cannot be loosened from the stirling cooler 200 due to vibration generated during actual use, thereby ensuring the connection firmness of the components in the refrigeration device in the present embodiment. And the heat conduction fastener 500 has stronger heat conduction performance, and can better realize the energy exchange of the Stirling cold head 200 and the coil fixing piece 300.

As shown in fig. 5, in one embodiment of the present application, the refrigeration apparatus further includes a bottom plate 310, where the bottom plate 310 is connected to an end surface of the coil fixing member 300 away from the refrigeration unit 100, and forms a receiving cavity together with the coil fixing member 300 to cover the heat conducting fastener 500; the refrigeration device further includes a temperature detecting member 600, where the temperature detecting member 600 is disposed on a surface of the base plate 310 away from the heat conducting fastener 500, for detecting a real-time temperature value.

Specifically, the temperature detecting component 600 may be a temperature measuring instrument such as an infrared temperature sensor, a radiation thermometer, a thermocouple, a thermal resistor, and the like.

By way of example, the coil mount 300 may be integrally formed with the base plate 310 to form a cap-like member having a receiving cavity, the cap-like member being capable of covering the heat-conductive fastener 500 when the cap-like member is coupled to the heat-conductive fastener 500 fitted over the Stirling cold head 200, i.e., corresponding to the cap-like member being disposed at an end of the Stirling cold head 200 remote from the refrigeration unit 100, while the temperature detecting member 600 may employ a thermocouple disposed at a surface of the base plate 310 remote from the heat-conductive fastener 500 to detect the temperature of the base plate 310, and since the base plate 310 is integrally formed with the coil mount 300 and the coil mount 300 is welded integrally with the cooling tube 400, it may be considered that the temperature detecting member 600 detects the temperature of the cooling tube 400, i.e., the temperature of the refrigerant in the cooling tube 400.

As shown in fig. 2, in this embodiment, a bottom plate 310 is disposed at one end of the coil fixing member 300 away from the refrigeration unit 100, so that when the coil fixing member 300 is connected to the heat conducting fastening member 500, at least most of the structure of the heat conducting fastening member 500 can be covered by the cover-shaped member formed by the bottom plate 310 and the coil fixing member 300. The surface of the bottom plate 310 far away from the heat conduction fastener 500 is further provided with a temperature detection component 600, so that real-time temperature detection of the cooling tube 400 arranged on the coil fixing piece 300 is realized, and the actual effect of the refrigerating device in the embodiment on refrigerating the refrigerant in the cooling tube 400 can be intuitively known through the temperature detection component 600.

As shown in fig. 4, in one embodiment of the present application, the heat-conducting fastener 500 includes a barrel-shaped body 510, the inner diameter of the barrel-shaped body 510 is adjustable, and the surface of the cooling surface includes a through hole 520, the barrel-shaped body 510 is used for surrounding and fixing one end of the stirling cooler 200 far away from the refrigeration unit 100, the coil fixing member 300 is sleeved on the barrel-shaped body 510, so that the cooling tube 400 in the pipe groove 311 is indirectly connected with the cooling surface through the inner wall of the through hole 520, thereby realizing energy transfer, and meanwhile, the distal end surface of the stirling cooler 200 can also be in contact with the inner surface of the bottom plate 310, thereby realizing energy transfer.

Specifically, the barreled body 510 may be an open-loop design, and a nut is used to implement closed-loop connection of the barreled body 510, and the tightness of the nut determines the inner diameter of the barreled body 510. That is, the barreled body 510 may include one or two C-shaped structures, and have one or two openings and fastening structures and nuts correspondingly disposed at the openings, and the size of the openings may be adjusted by the cooperation of the nuts and fastening structures, thereby adjusting the inner diameter of the barreled body 510.

As shown in fig. 3, at least one notch 312 is provided on the other side of the coil fixing member 300 opposite to the bottom plate 310, and when the coil fixing member 300 is connected to the heat conducting fastener 500, the position of the notch 312 matches with the fastening structure and the position of the nut on the barreled body 510, so that the assembled refrigeration device in this embodiment is more beautiful and occupies a smaller volume.

Preferably, a heat conductive layer may be disposed between the barreled body 510 and the stirling cooler 200, and the heat conductive layer may be made of a heat conductive silicone grease to fill the gap between the cooling surface of the stirling cooler 200 and the barreled body 510, so that the loss during the temperature transfer process is reduced.

As shown in fig. 4, in this embodiment, the barrel-shaped body 510 can correspondingly adjust the inner diameter according to the size of the stirling cold head 200, so that the cooling surface of the stirling cold head 200 can be fully wrapped by the barrel-shaped body 510, the cooling surface of the stirling cold head 200 can be in seamless contact with the barrel-shaped body 510, the design of the adjustable inner diameter enables the heat-conducting fastener 500 to be applicable to cold heads with different sizes, the universality is higher, and after the size of the coil fixing piece 300 is determined, even though the stirling cold heads 200 with different specifications are adopted, the coil fixing piece 300 can be firmly connected with the stirling cold head 200 through the size adjustment of the heat-conducting fastener 500; and the barreled body 510 is provided with the through hole 520, so that the Stirling cold head 200 in the embodiment can directly contact with the coil fixing piece 300 through the through hole 520, and the energy of the Stirling cold head 200 can be directly transmitted to the coil fixing piece 300 without passing through the heat conducting fastener 500.

In one embodiment of the present application, the refrigeration device further includes a thermally conductive layer disposed between the coil mount 300 and the contact surface of the barrel body 510.

Specifically, the heat conducting layer can be a coating with better heat conducting performance, such as an aluminum nitride coating, a boron nitride coating, an aluminum oxide coating or a heat conducting silicone grease coating.

As an example, a thermally conductive silicone grease may be used as the thermally conductive layer, uniformly coated between the mating surfaces of the coil mount 300 and the barreled body, to fill the gap between the coil mount 300 and the barreled body 510, such that losses during temperature transfer are reduced.

As shown in fig. 1, 5 and 6, in one embodiment of the present application, the refrigeration apparatus further includes a heating assembly 700 and a controller 800, the heating assembly 700 being disposed on a surface of the base plate 310 remote from the heat conductive fastener 500; the controller 800 is electrically connected to the temperature detecting component 600 and the heating component 700, and is configured to control the heating component 700 to heat when the real-time temperature value is lower than the preset phase change threshold, so that the real-time temperature value of the refrigerant in the cooling tube is within the preset safe ablation range.

Specifically, the heating assembly 700 may be an electric heating device such as a resistance wire, an electric heating tube, an electric heating sheet, or the like.

Although in the present embodiment, the heating assembly 700 is disposed above the bottom plate 310, those skilled in the art will appreciate that the heating assembly 700 may also be disposed on the coil mount 300, which is not a limitation of the present invention.

The preset safe ablation range refers to a temperature range set in advance by a user according to an actually adopted refrigerant, as an example, the refrigerant in the cooling tube 400 adopts laughing gas, the critical temperature of the laughing gas is-89 ℃, when the refrigerating device refrigerates the refrigerant in the cooling tube 400 so that the temperature of the laughing gas is lower than-89 ℃, the laughing gas is subjected to phase change, and is converted from liquid/gas state to solid state, so that the cooling tube 400 is blocked, therefore, in the embodiment, the preset safe ablation range with the lowest temperature being higher than-89 ℃ is set, the lowest value of the preset safe ablation range is a preset phase change threshold, for example, the preset safe ablation range can be [ -80 ℃, -50 ℃), the preset phase change threshold is-80 ℃, and the refrigerant can keep a lower temperature in the range, so that the cooling rate of the cryoablation balloon at a patient part in the ablation process is faster, and the phase change cannot occur, so that the cooling tube 400 is blocked.

By way of example, using an electrical heater strip as the heating assembly 700, the electrical heater strip may be affixed to the surface of the base plate 310 remote from the thermally conductive fastener 500, and then the electrical heater strip heats the coil mount 300 by heating the base plate 310, thereby heating the cooling tube 400 welded to the coil mount 300 as one, thereby achieving the purpose of heating the coolant.

In this embodiment, the heating assembly 700 is connected to one side of the bottom plate 310 far away from the cooling unit 100, the controller 800 is electrically connected to the temperature detecting component 600 and the heating assembly 700, respectively, the controller 800 can obtain the real-time temperature value of the bottom plate 310, namely, the real-time temperature value of the refrigerant through the temperature detecting component 600, and when the real-time temperature value is lower than the preset phase-change threshold value, the heating assembly 700 is controlled to heat the bottom plate 310 so as to achieve the purpose of heating the refrigerant, so that the actual temperature of the refrigerant can be kept within the preset safe ablation range.

As shown in fig. 5, in one embodiment of the present application, an electric heating plate 700 has a plurality of clamping grooves 710; screw holes are formed in the contact end surfaces of the heat conduction fasteners 500 and the bottom plate 310, and are uniformly distributed in the clamping grooves 710; the coil mount 300 is connected to the thermally conductive fastener via bolts disposed within the threaded bores.

As an example, the electric heating sheet may be of an X-type, and then the electric heating sheet includes four clamping grooves, the heat conductive fastener 500 is provided with screw holes at one end far away from the refrigerating unit 100, the screw holes may be blind holes or through holes, the bottom plate 310 is provided with screw holes at corresponding positions, the screw holes on the bottom plate 310 may be through holes, and bolts sequentially pass through the screw holes on the bottom plate 310 and the heat conductive fastener 500 to connect the bottom plate 310 and the heat conductive fastener 500 into a whole, and since the bottom plate 310 is connected with the coil fixing member 300, when the bottom plate 310 and the heat conductive fastener 500 are connected, the coil fixing member 300 and the heat conductive fastener 500 are also connected into a whole, and nuts on the bolts are uniformly distributed on one surface of the bottom plate 310 far away from the heat conductive fastener 500 and are respectively located in the clamping grooves of the electric heating sheet.

Further, in order to prevent the thermocouple from falling off the coil fixing member 300 due to vibration during the actual use, the thermocouple may be wound around the stud of any one of the bolts, so that when the bolt is screwed with the screw hole, the head of the bolt presses the thermocouple, and the thermocouple is fixed on the surface of the bottom plate 310 far from the heat conducting fastener 500.

In an alternative embodiment, a plurality of thermocouples are adopted as the temperature detecting component 600, and the plurality of thermocouples are respectively wound on the studs of the plurality of bolts which are uniformly distributed, so that when the bolts are in screwed connection with the screw holes, the nuts of the bolts cover the thermocouples, the thermocouples are fixed on the surface of the bottom plate 310 far away from the heat conducting fastener 500, at this time, the controller 800 can obtain the temperature values detected by the plurality of thermocouples, average the plurality of temperature values, and take the average value as a final real-time temperature value, so that errors of the detected temperature caused by different positions of the distribution of the thermocouples can be eliminated, and by the arrangement, the real-time temperature value with smaller actual temperature errors can be obtained, thereby realizing the accurate control of the temperature of the refrigerant by the refrigerating device in the embodiment.

As shown in fig. 7, in one embodiment of the present application, the controller 800 is also electrically connected to the refrigeration unit 100.

Specifically, the controller 800 may be configured to:

at the initial stage of refrigeration, the refrigeration unit 100 is controlled to quickly cool at a preset full-load power;

the temperature detection part 600 is controlled to detect the real-time temperature value of the coil fixing member 300 from any time within a first preset time before cryoablation to the end of cryoablation, and the real-time temperature value is controlled to be within a preset safe ablation range by adopting a proportional-integral-derivative algorithm.

The first preset time may be adjusted according to actual use requirements, and the first preset time may be 0s, that is, means that from cryoablation, the controller 800 controls the temperature detecting component 600 to detect a real-time temperature value of the coil fixing member 300, and controls the real-time temperature value to be within a preset safe ablation range by adopting a pid algorithm.

Since in an actual operation, the refrigerating apparatus may need to stand by for different time after starting to refrigerate, at this time, the refrigerating apparatus needs to maintain full refrigerating power to ensure that the refrigerating unit 100 can rapidly cool the refrigerant when starting to ablate, but the refrigerant changes phase at a certain low temperature to be solid from gas/liquid state, thereby causing the cooling tube 400 to be blocked, the controller 800 controls the temperature detecting unit 600 to detect the real-time temperature value of the coil fixing member 300, and when the real-time temperature value is lower than the preset phase change threshold, the heating assembly 700 is controlled to heat, so that the real-time temperature value is within the preset safe ablation range.

Specifically, according to the real-time temperature value, an incremental PD control algorithm or an incremental PID control algorithm can be adopted to control the actual temperature value to be in a preset safe ablation range.

In this embodiment, the controller 800 can control the refrigeration unit 100 to quickly cool with preset full power at the initial stage of refrigeration, so that the temperature of the cryoablation balloon can be quickly reduced, thereby providing the best temperature state for the operation, and during the period from any time in the first preset time before the cryoablation to the end of the cryoablation, the temperature detection component 600 is controlled to detect the real-time temperature value of the coil fixing piece 300, and the proportional-integral-derivative algorithm is adopted to control the real-time temperature value to be within the preset safe ablation range, so that the real-time temperature value detected by the temperature detection component 600 can be just within the preset safe ablation range at the beginning of the cryoablation, the refrigerant can not cause the cooling tube 400 to be blocked while providing the lower temperature for the cryoablation balloon, thereby ensuring the good operation of the refrigeration device, so that the operation can be better performed, and the operation time is not prolonged because the temperature provided by the cryoablation balloon is not low enough or the cooling tube 400 in the refrigeration device is blocked.

As shown in fig. 8, in one embodiment of the present application, the refrigeration apparatus further includes an interaction unit 900, and the interaction unit 900 is electrically connected to the controller 800, for displaying a real-time temperature value; and/or acquiring a preset safe ablation range set by a user.

Specifically, the interaction unit 900 is a graphical interaction interface (Graphical User Interface, GUI) disposed on a terminal, where the terminal may be, but not limited to, various personal computers, notebook computers, smart phones, tablet computers, internet of things devices, and portable wearable devices, and the internet of things devices may be smart televisions, smart vehicle devices, and the like. The portable wearable device may be a smart watch, smart bracelet, headset, or the like.

Further, in the refrigerating apparatus in the above embodiment, the user may set the preset safe ablation range, the start time of cryoablation and the first preset time through the interaction unit 900, then the controller 800 continuously controls the temperature detecting component 600 to detect the real-time temperature value of the coil fixing component 300 in a period from the first preset time before the start time of cryoablation to the end of cryoablation, at this time, the user may also obtain the real-time temperature value detected by the temperature detecting component 600 through the interaction unit 900, the controller 800 may also obtain the preset safe ablation range through the interaction unit 900, and determine whether the real-time temperature value is lower than the preset phase change threshold, if yes, the heating component 700 is controlled by adopting the pid algorithm to heat the bottom plate 310, so as to achieve the purpose of heating the refrigerant, so that the actual temperature of the refrigerant can be kept within the preset safe ablation range, and by this setting, the temperature of the balloon center in the ablation process can be better at the cooling rate provided by the patient, thereby ensuring that the doctor can complete the operation better and safer.

In an embodiment of the present application, the interaction unit 900 may be further configured to obtain a preset detection frequency.

The preset detection frequency means, for example, a frequency at which the temperature detecting part 600 detects the coil fixture 300.

In the refrigerating apparatus in the above embodiment, the user may set the preset detection frequency, the preset safe ablation range, the start time of cryoablation and the first preset time through the interaction unit 900, then the controller 800 continuously controls the temperature detection component 600 to detect the real-time temperature value of the coil fixing member 300 according to the preset detection frequency in a period from the first preset time before the start time of cryoablation to the end of cryoablation, at this time, the user may also obtain the real-time temperature value detected by the temperature detection component 600 through the interaction unit 900, the controller 800 may also obtain the preset safe ablation range through the interaction unit 900 and determine whether the real-time temperature value is lower than the preset phase change threshold, if yes, the heating component 700 is controlled by adopting the proportional integral derivative algorithm to heat the bottom plate 310, so as to achieve the purpose of heating the refrigerant, so that the actual temperature of the refrigerant can be kept within the preset safe ablation range.

As an example, as shown in fig. 9, which shows an electrical structure diagram of the controller 800 in this embodiment, the controller 800 includes a micro control unit (Microcontroller Unit, MCU), an analog-to-digital converter (Analogical Digital, AD), a graphic user interface (Graphical User Interface, GUI), an amplifier and a driving circuit, and in the actual control process, a user can set/change a preset safe ablation range through the GUI before or during the ablation process, in the initial stage of cooling, the MCU controls the cooling unit 100 to quickly cool down at a preset full power, and starts to freeze-ablate in a time period from any time in a first preset time before freeze-ablate, the temperature detecting part 600 collects an analog signal of the temperature of the coil fixing member 300, the MCU converts the analog signal into a digital signal through the AD and converts the digital signal into a corresponding temperature, that is, a real-time temperature value, then the MCU displays the real-time temperature value through the GUI, and when the real-time temperature value is lower than a preset phase-change threshold, calculates a target digital signal through a proportional-integral-derivative algorithm, converts the target digital signal into a target analog signal through the digital-to-analog-converter (Digital Analogical), and then applies the target analog signal to the driving circuit 700 to the heating member 700 to the heating assembly after the heating assembly, thereby realizing the heating assembly 700.

As an example, the controller 800 uses the PID controller to control that the real-time temperature value is within the preset safe ablation range by adopting the PID controller and the PID control algorithm, as shown in fig. 10, in the PID control schematic diagram, r (t) is a temperature value within the preset safe ablation range, for example, may be a lowest temperature value within the preset safe ablation range, y (t) is an actual temperature value, and a control deviation e (t) is formed by setting the temperature value within the preset safe ablation range and the actual temperature value, e (t) =r (t) -y (t), where e (t) is used as an input of the PID controller, and y (t) is used as an output of the PID controller and an input of the controlled variable.

The control of the proportion (P) can quickly respond to errors, and plays a larger role when the errors are larger. However, the proportional control cannot eliminate steady state errors. An increase in the scaling factor may cause instability of the system. The effect of the integral (I) control is: as long as the system has errors, the integral is continuously accumulated, and the control quantity is output to eliminate the errors. As long as there is enough time, the integral control will be able to completely eliminate the error, bringing the systematic error close to zero, thus eliminating the steady state error. However, excessive integration can cause excessive overshoot and even oscillations in the system. The differential (D) control can reduce overshoot, overcome oscillation, improve the stability of the system, accelerate the dynamic response speed of the system, and reduce the adjustment time, thereby improving the dynamic performance of the system. According to the control characteristics of different controlled objects, the control model can be divided into P, PI, PD, PID and other different control models, and the temperature control is commonly used in two modes of proportional differentiation (Proportion Differentiation, PD) and proportional integral differentiation (Proportion Integration Differentiation, PID) PID.

The PID control schematic diagram simulates a PID formula:

in the above formula, u (t) is an output signal of PID control, e (t) is a control deviation formed by a temperature value in a preset safety ablation range and an actual temperature value, K _p Representing the proportionality coefficient, T _l Representing the integration time, T _D The differential time is represented, u (0) is a control constant, and t is a time constant. Discretizing the PID formula: instead of integration by summation and differentiation by delta, the following transformation is performed in equation (1-1):

t≈kT k∈[1,N] (1-2)

in the above formula, T is the sampling period, j and k are sampling sequence numbers, N is the total number of samples, T is the time constant, and corresponds to kT, e _t And e _t-1 Representing the offset values twice in succession.

Discrete expressions (1-5) can be obtained from formulas (1-2), formulas (1-3) and formulas (1-4):

deriving an incremental PID formula from the above formulas (1-5):

Δμ _k ＝μ _k -μ _k-1

e _t ＝r(t)-y(t) (1-7)

in the above formula, deltau _k Is the increment of the control quantity, K _p Is a proportionality coefficient, T _i Is an integral parameter, td is a differential parameter, e _k 、e _k-1 And e _k-2 The deviations of three consecutive sample values, T, represent the sample period, and for a PID controller the samples are input, the control is output, and the normal sample period is taken as the control period. The control period for the heating assembly 700 is dependent on the actual response and may range from 500ms to 2s.

If the heating assembly 700 is controlled to heat the coil fixing member 300 so that the actual temperature value detected by the temperature detecting member 600 can reach the preset safe ablation range, it is required to control whether the heating assembly 700 does work, that is, to control the heating power of the heating assembly 700 to be 0 or more than 0, so as to realize accurate control of the temperature of the refrigerant, so that the temperature of the refrigerant can be kept in the preset safe ablation range.

Further, in one embodiment of the present application, there is provided a cryoablation system including a cryoablation balloon 15, a solenoid valve 16, and the refrigeration device described above, the cryoablation balloon 15 being configured to effect heat transfer between a refrigerant flowing through the cryoablation balloon and the outside world; a solenoid valve 16 is provided in the vent path of the cryoablation balloon for controlling the flow of refrigerant to be within a preset safe flow threshold. The refrigerating device comprises a refrigerating unit 100, a Stirling cold head 200, a coil fixing piece 300, a cooling pipe 400, a heat conduction fastening piece 500, a temperature detection component 600, a heating component 700, a controller 800 and an interaction unit 900, wherein the refrigerating unit 100 is used for refrigerating, and the Stirling cold head 200 is connected with the refrigerating unit 100; the coil fixing piece 300 is connected with the cooling surface of the Stirling cold head 200, the Stirling cold head 200 realizes heat transfer through the cooling surface and the cooling pipe 400 arranged on the coil fixing piece 300, the side wall of the coil fixing piece 300 is provided with an annular pipeline groove 311, and the pipeline groove 311 is used for accommodating the cooling pipe 400; the bottom plate 310 is connected to the end surface of the coil holder 300 remote from the refrigeration unit 100 for forming a receiving cavity for the heat conductive fastener 500. The heat conduction fastener 500 is sleeved at one end of the Stirling cold head 200 away from the refrigeration unit 100, and is used for connecting the coil fixing member 300 and the Stirling cold head 200 and conducting temperature, and the heat conduction fastener 500 comprises: the barrel-shaped body has an adjustable inner diameter and the bottom surface comprises a through hole for encircling and fixing one end of the Stirling cold head 200 far away from the refrigeration unit 100, so that the cooling pipe 400 in the pipeline groove 311 is contacted with the cooling surface through the through hole. The temperature detecting component 600 is disposed on a surface of the bottom plate 310 away from the heat conducting fastener 500, and is used for detecting a real-time temperature value; the heating assembly 700 is arranged on the surface of the bottom plate 310 away from the heat conducting fastener 500; the controller 800 is electrically connected to the temperature detecting component 600 and the heating component 700, and is configured to control the heating component 700 to heat when the real-time temperature value is lower than the preset phase change threshold value, so that the real-time temperature value is within the preset safe ablation range; the controller 800 is also electrically connected to the refrigeration unit 100, and the controller 800 may be configured to: at the initial stage of refrigeration, the refrigeration unit 100 is controlled to quickly cool at a preset full-load power; the temperature detection part 600 is controlled to detect the real-time temperature value of the coil fixing member 300 from any time within a first preset time before cryoablation to the end of cryoablation, and the real-time temperature value is controlled to be within a preset safe ablation range by adopting a proportional-integral-derivative algorithm.

As shown in fig. 11, as an example, the cryoablation system in the present embodiment includes a refrigerant tank 11, a pressure reducing valve 12, a high-pressure proportional valve 13, the above-described refrigerating device 14, a cryoablation balloon 15, a solenoid valve 16, a vacuum pump 17, a flow meter 18, and an air return reserve device 19 connected in this order, wherein the refrigerant tank 11, the pressure reducing valve 12, the high-pressure proportional valve 13, and the refrigerating device 14 are located in a liquid supply passage of the cryoablation balloon 15, and the refrigerant tank 11 is used for storing a refrigerant; the pressure reducing valve 12 and the high-pressure proportional valve 13 are used for controlling the air pressure value of the refrigerant in the liquid supply passage of the cryoablation balloon 15; the refrigerating device 14 is used for precisely controlling the temperature of the refrigerant; the electromagnetic valve 16, the vacuum pump 17, the flowmeter 18 and the return air reserve device 19 are positioned in the exhaust passage of the cryoablation balloon 15, and the flow rate of the electromagnetic valve 16 for controlling the refrigerant is positioned within a preset safe flow rate threshold value range; the vacuum pump 17 is used for sucking out the refrigerant in the cryoablation balloon; the flowmeter 18 is used for acquiring the real-time flow rate of the refrigerant; the return air reserve 19 is used for recovering the refrigerant. A one-way valve is further arranged between the refrigerant accumulator tank 11 and the pressure reducing valve 12 and used for controlling one-way flow of the refrigerant in the liquid supply passage of the cryoablation balloon 15, a pressure gauge is arranged between the pressure reducing valve 12 and the high-pressure proportional valve 13 and used for controlling flow of the refrigerant in the liquid supply passage of the cryoablation balloon 15, and a pressure sensor is arranged between the high-pressure proportional valve 13 and the refrigerating device 14 and used for acquiring a real-time pressure value of the refrigerant in the liquid supply passage of the cryoablation balloon 15; a pressure sensor is arranged between the cryoablation balloon 15 and the electromagnetic valve 16 and used for acquiring a real-time pressure value of the refrigerant in the exhaust passage of the cryoablation balloon 15, a low-pressure proportional valve is arranged in parallel with the electromagnetic valve 16 and used for controlling a pressure value of the refrigerant in the exhaust passage of the cryoablation balloon 15, and a one-way valve is arranged between the electromagnetic valve 16 and the vacuum pump 17 and used for controlling one-way flow of the refrigerant in the exhaust passage of the cryoablation balloon 15.

Specifically, in the cryoablation system in the above embodiment, the controller 800 in the refrigeration device 14 can obtain the real-time temperature value of the bottom plate 310, that is, the approximate real-time temperature value of the refrigerant through the temperature detection component 600, and when the real-time temperature value is lower than the preset phase change threshold of the refrigerant, the heating component 700 is controlled to heat the bottom plate 310, so as to achieve the purpose of heating the refrigerant, so that the actual temperature of the refrigerant can be kept within the preset safe ablation range.

Further, in the cryoablation system in the above embodiment, the controller 800 in the refrigerating device 14 can also control the refrigerating unit 100 to rapidly cool down at the preset full power at the initial stage of refrigeration to ensure that the refrigerating unit 100 can rapidly cool down the refrigerant when the ablation is started, thereby providing the best temperature state for the operation, and the controller 800 controls the temperature detecting component 600 to detect the real-time temperature value of the coil fixing member 300 during the period from any time of the first preset time before the cryoablation to the end of the cryoablation, and controls the heating component 700 to heat up when the real-time temperature value is lower than the preset phase change threshold, so that the real-time temperature value is within the preset safe ablation range.

As shown in fig. 12, further, in one embodiment of the present application, there is provided a cryoablation temperature control method for cooling a cooling tube delivering a refrigerant to a cryoablation balloon, the method comprising:

step 202: the refrigeration unit 100 is controlled to cool the cooling pipe 400 on the coil fixing piece 300 through the Stirling cold head 200, and the coil fixing piece 300 is connected with the cooling surface of the Stirling cold head 200;

step 204: and acquiring a real-time temperature value of the cooling pipe 400, and controlling the heating assembly 700 to heat under the condition that the real-time temperature value is lower than a preset phase change threshold value, so that the real-time temperature value is positioned in a preset safe ablation range, and the heating assembly 700 is arranged on the coil fixing piece 300.

As an example, the refrigeration unit 100 is controlled by the controller 800 to cool down the cooling tube 400 on the coil mount 300 via the stirling cooler head 200, the controller 800 being configured, for example: at the initial stage of refrigeration, the refrigeration unit 100 is controlled to rapidly cool at a preset full power to ensure that the refrigeration unit 100 can rapidly cool the refrigerant when ablation is started, thereby providing the best temperature state for the operation.

Further, the coil fixing member 300 may be connected to the stirling cooler 200 by using the heat conducting fastener 500, where the heat conducting fastener 500 is sleeved on an end of the stirling cooler 200 away from the refrigeration unit 100, so that the connection between the coil fixing member 300 and the stirling cooler 200 is firmer, and the coil fixing member 300 cannot be loosened from the stirling cooler 200 due to vibration generated in the actual use process, thereby ensuring the firmness of the connection of the components in the refrigeration device. And the heat conduction fastener 500 can be made of copper, has strong heat conduction performance, and can better realize energy exchange between the Stirling cold head 200 and the coil fixing piece 300.

As an example, the temperature detecting part 600 is used to obtain a real-time temperature value of the cooling tube 400, and a preset phase change threshold and a preset safe ablation range are set according to a critical temperature of the actually used refrigerant, so as to determine whether the real-time temperature value is lower than the preset phase change threshold, and when the real-time temperature value is lower than the preset phase change threshold, the heating assembly 700 is controlled to heat, so that the real-time temperature value is within the preset safe ablation range.

As an example, the controller 800 is used to control the temperature detecting part 600 to obtain a real-time temperature value of the cooling tube 400 according to a preset frequency, to set a preset phase change threshold and a preset safe ablation range according to a critical temperature of the actually used refrigerant, and to control the heating assembly 700 to heat when the real-time temperature value is lower than the preset phase change threshold, so that the real-time temperature value is within the preset safe ablation range.

Further, the interaction unit 900 is adopted to obtain the preset frequency, the preset phase change threshold value and the preset safe ablation range input by the user, then the controller 800 controls the temperature detection component 600 to detect the real-time temperature value of the coil pipe fixing piece 300 according to the preset detection frequency, the controller 800 also obtains the preset safe ablation range through the interaction unit 900 and judges whether the real-time temperature value is lower than the preset phase change threshold value, if yes, the heating component 700 is controlled by adopting the proportional-integral-derivative algorithm to heat the bottom plate 310 so as to achieve the purpose of heating the refrigerant, the actual temperature of the refrigerant can be kept in the preset safe ablation range, and by means of the arrangement, the temperature reduction rate provided by the temperature of the center of the balloon at the patient part in the ablation process is better, so that doctors can finish operations better and safer.

Further, when the interaction unit 900 is used to obtain the start time and the first preset time of cryoablation input by the user, the controller 800 continuously controls the temperature detection component 600 to detect the real-time temperature value of the coil fixing member 300 according to the preset detection frequency in a period from the first preset time before the start time of cryoablation to the end of cryoablation, the controller 800 also obtains the preset safe ablation range through the interaction unit 900 and judges whether the real-time temperature value is lower than the preset phase change threshold, if yes, the heating component 700 is controlled to heat the bottom plate 310 by adopting the proportional integral derivative algorithm, so as to achieve the purpose of heating the refrigerant, so that the actual temperature of the refrigerant can be kept within the preset safe ablation range, and by adopting the setting, the temperature of the center of the balloon in the ablation process can be better at the cooling rate provided by the patient part, thereby ensuring that a doctor can complete the operation better and safer.

Specifically, the heating assembly 700 employs an electric heating sheet, which may be stuck on the coil holder 300, and heats the refrigerant by heating the coil holder 300, so that the actual temperature of the refrigerant can be maintained within a preset safe ablation range.

It should be understood that, although the steps in the flowchart of fig. 12 are shown in order as indicated by the arrows, the steps are not necessarily performed in order as indicated by the arrows. The steps are not strictly limited to the order of execution unless explicitly recited herein, and the steps may be executed in other orders. Moreover, at least some of the steps in fig. 12 may include multiple sub-steps or stages that are not necessarily performed at the same time, but may be performed at different times, or the order in which the sub-steps or stages are performed is not necessarily sequential, but may be performed in rotation or alternatively with at least a portion of the sub-steps or stages of other steps or steps.

As shown in fig. 13, experiments show that, by using the refrigeration device provided in the embodiment of the present application and the conventional refrigeration device using the common compressor with the working medium R134a, after the same time of refrigeration, the obvious cooling speed is faster and the temperature of the freezing balloon is lower by using the refrigeration device provided in the embodiment of the present application; by using the refrigerating device provided in the embodiment of the application and the conventional refrigerating device, a comparison diagram of air inlet pressure generated by the cryoablation balloon is shown as fig. 14, and experiments show that when the temperature of the cryoablation balloon is reduced to the same temperature, the air inlet pressure of the refrigerating device provided in the embodiment of the application, which is caused by the refrigerating device, is lower than the air inlet pressure of the conventional refrigerating device, which is caused by the conventional refrigerating device, by nearly 70psi, and through multiple experiments, a gap of 100psi can be found to exist between the maximum air inlet pressure difference, so that the rupture of the cryoablation balloon caused by the overlarge pressure of the cryoablation balloon is prevented, and safer protection is realized. It is clear that the air inlet pressure value that the refrigeration device provided by the application can reduce is not limited to below 100psi, and the air inlet pressure value that the application can reduce is different for different refrigerants.

The technical features of the above-described embodiments may be arbitrarily combined, and all possible combinations of the technical features in the above-described embodiments are not described for brevity of description, however, as long as there is no contradiction between the combinations of the technical features, they should be considered as the scope of the description.

The above examples only represent a few embodiments of the present application, which are described in more detail and are not to be construed as limiting the scope of the claims. It should be noted that it would be apparent to those skilled in the art that various modifications and improvements could be made without departing from the spirit of the present application, which would be within the scope of the present application. Accordingly, the scope of protection of the present application is to be determined by the claims appended hereto.

Claims

1. A refrigeration device, comprising:

a refrigerating unit;

the Stirling cold head is connected with the refrigerating unit;

a fixed member connected to a cooling surface of the Stirling cold head;

and the cooling pipe is arranged on the fixing part and used for cooling the refrigerant used for cryoablation, and the Stirling cold head cools the cooling pipe arranged on the fixing part through the cooling surface.

2. The refrigeration unit as recited in claim 1 wherein said securing means comprises a coil securing member, a side wall of said coil securing member being provided with an annular channel recess for receiving said cooling tube; the coil pipe fixing piece is sleeved on the Stirling cold head, so that heat transfer is achieved between the cooling pipe in the pipeline groove and the cooling surface.

3. The refrigeration unit of claim 2 wherein said cooling tube is welded into said tube recess by a vacuum welding process.

4. The refrigeration unit as recited in claim 2 further comprising:

the bottom plate is connected with the end face, far away from the refrigerating unit, of the coil fixing piece;

and the temperature detection component is arranged on the surface, far away from the refrigerating unit, of the bottom plate and is used for detecting a real-time temperature value.

5. The refrigeration unit as recited in claim 4 further comprising:

the heating component is arranged on the bottom plate or the coil pipe fixing piece;

and the controller is electrically connected with the temperature detection component and the heating component and is used for controlling the heating component to heat under the condition that the real-time temperature value is lower than a preset phase change threshold value, so that the real-time temperature value is positioned in a preset safe ablation range.

6. The refrigeration unit of claim 5 wherein said heating assembly comprises an electrical heater strip attached to a surface of said base plate remote from said refrigeration unit.

7. The refrigeration apparatus of claim 6, wherein the electrical heater strip is X-shaped to form a plurality of snap-fit grooves; screw holes are formed in the bottom plate and are uniformly distributed in the clamping grooves.

8. The refrigeration unit of claim 2, wherein the fixing member comprises:

and the heat conduction fastener is sleeved on the Stirling cold head and used for connecting the coil fixing piece with the Stirling cold head and conducting heat transfer.

9. The refrigeration unit as recited in claim 8 further comprising said temperature detecting means disposed on a surface of said base plate remote from said refrigeration unit for detecting a real-time temperature value, said temperature detecting means including a thermocouple disposed on a surface of said base plate remote from said heat conductive fastening portion; the coil pipe fixing piece is sleeved on the heat conduction fastening piece.

10. The refrigeration unit as recited in claim 9 wherein screw holes are provided in both of said heat conductive fastener and said bottom plate at the contact end surfaces thereof; the coil pipe fixing piece is connected with the heat conduction fastening piece through a bolt arranged in the screw hole; the thermocouple is wound on the stud of the bolt, so that when the bolt is in threaded connection with the screw hole, the head of the bolt presses the thermocouple, and the thermocouple is fixed on the surface, far away from the heat conduction fastener, of the bottom plate.

11. The refrigeration device of any one of claims 8-10 wherein the thermally conductive fastener comprises:

the inner diameter of the barrel-shaped body is adjustable, the barrel-shaped body is provided with a through hole matched with the cooling surface, and the barrel-shaped body is used for encircling and fixing the cooling surface to one end of the Stirling cold head, which is far away from the refrigerating unit, so that the cooling pipe in the pipeline groove is contacted with the cooling surface through the through hole.

12. The refrigeration unit as recited in claim 11 further comprising:

and the heat conducting layer is arranged between the coil fixing piece and the matching surface of the barrel-shaped body.

13. The refrigeration unit of claim 12 wherein said thermally conductive layer comprises:

and the heat conduction silicone grease is uniformly coated between the coil pipe fixing piece and the matching surface of the barrel-shaped body.

14. A refrigeration unit as recited in any one of claims 5 to 7 further comprising:

the interaction unit is electrically connected with the controller and used for displaying the real-time temperature value; and/or

And acquiring the preset safe ablation range set by the user.

15. The cooling device of claim 14, wherein the predetermined safe ablation range is [ -80 ℃, -50 ℃).

16. The refrigeration unit of any of claims 5-7, wherein the controller is electrically connected to the refrigeration unit and is configured to:

in the initial stage of refrigeration, controlling the refrigeration unit to quickly cool at a preset full-load power;

and controlling the temperature detection part to detect the real-time temperature value of the coil pipe fixing piece from any moment in a first preset time before cryoablation to the end of cryoablation, and controlling the real-time temperature value to be in a preset safe ablation range by adopting a proportional-integral-derivative algorithm.

17. A cryoablation system comprising:

a cryoablation balloon catheter comprising a cryoablation balloon for effecting heat transfer between a refrigerant flowing through the cryoablation balloon and the environment; and

the cooling device of any one of claims 1-16 wherein an outlet of the cooling tube is disposed inside the cryoablation balloon.

18. A cryoablation temperature control method for cooling a refrigerant used in cryoablation, the method comprising:

the cooling unit is controlled to cool down a cooling pipe on a coil fixing piece through the Stirling cold head, and the coil fixing piece is connected with a cooling surface of the Stirling cold head;

And acquiring a real-time temperature value of the cooling pipe, and controlling the heating component to heat under the condition that the real-time temperature value is lower than a preset phase change threshold value, so that the real-time temperature value is positioned in a preset safe ablation range, wherein the heating component is arranged on the coil pipe fixing piece.

19. The cryoablation temperature control method of claim 18 wherein the method further comprises: