WO2024012510A1 - Refrigeration device, and cryoablation system and method - Google Patents

Abstract

A refrigeration device, and a cryoablation system and method. The refrigeration device comprises: a refrigeration unit (100); a Stirling cold head (200), which is connected to the refrigeration unit (100); a fixing component, which is connected to a cooling surface of the Stirling cold head (200); and a cooling tube (400), which is arranged on the fixing component and is used for cooling a refrigerant used for cryoablation. The Stirling cold head (200) cools, by means of the cooling surface thereof, the cooling tube (400), which is arranged on the fixing component.

Description

Refrigeration device, cryoablation system and method

Cross-references to related applications

This disclosure claims priority to the Chinese patent application filed with the China Patent Office on July 14, 2022, with application number 2022108269449 and the invention name "refrigeration device, cryoablation system and method". The entire content of the patent application is incorporated by reference. incorporated in this disclosure.

Technical field

The present disclosure relates to the technical field of medical devices, and in particular to a refrigeration device, cryoablation system and method.

Background technique

Cryoablation, as a new surgical procedure for the treatment of atrial fibrillation, has received widespread attention in recent years. Its working principle is to take away tissue heat through the endothermic evaporation of liquid refrigerant, lowering the temperature of the target ablation site, "freezing" the cell tissue, thereby destroying the area with abnormal electrophysiological activity, so as to achieve the purpose of treating arrhythmia. A large amount of clinical data shows that compared with other ablation methods, cryoablation is easier for doctors to learn and operate, shortens the operation time, has high treatment effectiveness, reduces serious complications such as thrombosis, and reduces patient pain.

However, the traditional cryoablation system uses a fixed flow rate during the ablation stabilization process. The longer the ablation time, the lower the temperature, and cannot be maintained at a lower temperature. In order to prevent risks, the only option is to stop the ablation and wait for the temperature to recover. The next ablation process is cycled, which not only increases the difficulty of the operation and prolongs the time of the operation, but also increases the risks during the operation, resulting in poor isolation of the pulmonary veins and greater side effects on the tissue. As the number of cryoablation surgeries increases, the demand market has more demands for low temperature control in cryosurgery. How to maintain the balloon temperature within the demand range during cryoablation has become an urgent problem to be solved.

Contents of the invention

Based on this, it is necessary to address the problems in the above-mentioned background technology and provide a refrigeration device and cryoablation device that can control the temperature inside the cryoablation balloon to be within a preset safe ablation range and avoid the deformation of the cryoablation balloon from causing damage to the tissue. Systems and methods.

The first aspect of this application provides a refrigeration device, including a refrigeration unit, a Stirling cold head, a fixed component and a cooling pipe. The Stirling cold head is connected to the refrigeration unit; the fixed component is connected to the cooling surface of the Stirling cold head. ; The cooling tube is arranged on the fixed component and is used to cool the refrigerant used for cryoablation. The Stirling cold head cools the cooling tube arranged on the fixed component through the cooling surface. In this embodiment, a Stirling cold head is used in the cryoablation system. The Stirling cold head is used to transmit energy, which improves the cooling rate of ablation and reduces the air inlet pressure of the cooling tube, thereby improving the efficiency and efficiency of the operation. safety.

In one embodiment, the fixing component includes a coil fixing piece, the side wall of the coil fixing piece is provided with an annular pipeline groove, and the pipeline groove is used to accommodate the cooling pipe; the coil fixing piece The sleeve is placed on the Stirling cold head to achieve heat transfer between the cooling pipe and the cooling surface in the pipeline groove.

In one embodiment, the cooling pipe is welded into the pipe groove through a vacuum welding process. The cooling tube is embedded in the pipeline groove on the side wall of the coil fixture, and is welded to the pipeline groove as a whole through a vacuum welding process. Compared with previous cryoablation systems, the refrigeration device in this application has improved Due to the integration of coil fixings, the cooling pipe can more directly utilize the energy of the Stirling cold head, and the cooling pipe can more fully absorb the energy transmitted by the refrigeration unit through the cooling surface of the Stirling cold head.

In one embodiment, the refrigeration device further includes a base plate, which is connected to the end face of the coil fixing member away from the refrigeration unit; the refrigeration device also includes a temperature detection component, which is disposed on a surface of the base plate away from the refrigeration unit. To detect real-time temperature value.

In one embodiment, the refrigeration device further includes a heating component and a controller, which are disposed on a surface of the base plate away from the refrigeration unit; the controller is electrically connected to the temperature detection component and the heating component, and is used to detect when the real-time temperature value is lower than a preset phase. When the threshold value changes, the heating component is controlled to heat so that the real-time temperature value is within the preset safe ablation range. The controller can obtain the real-time temperature value of the cooling pipe on the coil fixing part through the temperature detection component, that is, the approximate real-time temperature value of the refrigerant, and when the real-time temperature value is lower than the preset phase change threshold, control the heating component to heat the coil The fixing piece is used to heat the refrigerant in the cooling tube so that the actual temperature of the refrigerant can be maintained within the preset safe ablation range. Through this setting, the temperature of the center of the cryoablation balloon can be kept within the patient's range during the ablation process. The cooling rate provided by the site is better, thus ensuring that the doctor can complete the operation better and safer.

In one embodiment, the heating assembly includes an electric heating plate attached to the base plate or the coil fixture. The electric heating plate occupies a large area and can heat the coil fixings more comprehensively and quickly.

In one embodiment, the electric heating plate is in an The bolts inside cause damage to the heating wire in the electric heating element.

In one embodiment, the fixing component includes: a thermally conductive fastener, which is sleeved on an end of the Stirling cold head away from the refrigeration unit and used to connect the coil fixing part and the Stirling cold head. Lin cold head and conduct heat transfer.

In one embodiment, the refrigeration device further includes the temperature detection component, which is disposed on the surface of the bottom plate away from the refrigeration unit for detecting real-time temperature values. The temperature detection component includes a thermocouple, which is disposed on the surface of the bottom plate away from the refrigeration unit. Surface of thermally conductive fasteners. The thermocouple installed on the surface of the bottom plate away from the heat-conducting fastener can realize real-time temperature detection of the cooling pipe installed on the coil fixing part. Through the thermocouple, the actual cooling of the refrigerant in the cooling pipe by the refrigeration device can be visually observed. Effect. The coil fixing piece is sleeved on the heat-conducting fastener, which can make the combined components of the refrigeration device occupy a smaller volume, achieve a higher degree of integration, and also make the assembled refrigeration device more beautiful.

In one embodiment, screw holes are provided on the contact end surfaces of the thermally conductive fasteners and the bottom plate, and the coil fixing member is connected to the thermally conductive fasteners through bolts provided in the screw holes. The bolts pass through the screw holes on the bottom plate and the heat-conducting fasteners in sequence, connecting the bottom plate, the coil fixing piece and the heat-conducting fasteners into a solid body, which improves the solidity of the assembled refrigeration device. The thermocouple is wound around the stud of the bolt, so that when the bolt is screwed into the screw hole, the head of the bolt presses the thermocouple and fixes the thermocouple to the surface of the base plate away from the heat-conducting fastener. The way the bolt head presses the thermocouple can prevent the thermocouple from falling off the coil fixture due to vibration during actual use.

In one embodiment, the thermally conductive fastener includes a barrel-shaped body, the inner diameter of the barrel-shaped body is adjustable and has a through hole matching the cooling surface, and is used to surround and fix the end of the Stirling cold head away from the refrigeration unit, so that the tube The cooling pipe in the groove is in contact with the cooling surface through the through hole. The inner diameter of the barrel body can be adjusted accordingly 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 body, and the cooling surface of the Stirling cold head and the barrel body can be seamlessly attached. , reduces the loss during energy transfer, improves the refrigeration efficiency of the refrigeration unit, and also allows different types of Stirling cold heads to be fastened to coil fixings of the same size, improving product adaptability.

In one embodiment, the refrigeration device further includes a heat conductive layer, the heat conductive layer is disposed between the coil fixing member and the barrel. between the mating surfaces of the body. The thermal conductive layer can fill the gap between the coil fixing part and the barrel body, reducing the loss during temperature transfer.

In one embodiment, the thermal conductive layer includes thermal conductive silicone grease and is evenly coated between the mating surface of the coil fixing member and the barrel body. Thermal silicone grease has good thermal conductivity and can reduce losses during temperature transfer.

In one embodiment, the refrigeration device further includes an interactive unit electrically connected to the controller for displaying real-time temperature values; and/or obtaining a preset safe ablation range set by the user. The user can obtain the real-time temperature value detected by the temperature detection component 600 through the interactive unit, and set the preset safe ablation range through the interactive unit 900, which improves the interactivity between the refrigeration device and the user.

In one embodiment, the preset safe ablation range is [-80°C, -50°C]. When the controller controls the real-time temperature value to be within the preset safe ablation range [-80°C, -50°C], it can make the temperature of the balloon center during the ablation process provide a better cooling rate at the patient site, and the cooling tube will not clogged.

In one of the embodiments, the controller is electrically connected to the refrigeration unit, and the controller is configured to: during the initial stage of refrigeration, control the refrigeration unit to quickly cool down at a preset full load power; From the beginning of time to the end of cryoablation, the temperature detection component is controlled to detect the real-time temperature value of the coil fixing part, and the proportional integral differential algorithm is used to control the real-time temperature value to be within the preset safe ablation range. In actual surgery, the refrigeration device may need to wait for different periods of time after starting to cool before starting the surgery. At this time, the refrigeration device needs to maintain full cooling power to ensure that the refrigeration unit can quickly cool down the refrigerant when ablation begins. However, due to the refrigerant Phase change will occur at low temperatures, from gas/liquid state to solid state, causing blockage of the cooling tube. Therefore, the controller controls the temperature detection component to detect the real-time temperature value of the coil fixture. When the real-time temperature value is lower than the preset phase change threshold, In this case, the heating component is controlled to heat so that the real-time temperature value is within the preset safe ablation range. This setting ensures that the refrigerant remains low while preventing the cooling pipe from being blocked.

A second aspect of the present application provides a cryoablation system, including a cryoablation balloon catheter and the refrigeration device described in any embodiment of the present application. The cryoablation balloon catheter includes a cryoablation balloon for achieving flow through the The refrigerant of the cryoablation balloon transfers heat to the outside world, and the outlet of the cooling tube is provided inside the cryoablation balloon. The cryoablation system uses the above-mentioned refrigeration device to replace the traditional refrigeration device. The refrigeration device includes a refrigeration unit, a Stirling cold head, a coil fixture, a cooling tube, a thermally conductive fastener, a temperature detection component, a heating component, a controller and an interactive unit , the refrigeration unit is used for refrigeration, and the Stirling cold head is connected to the refrigeration unit; the coil fixing piece is connected to the cooling surface of the Stirling cold head, and is used to cool down the cooling pipe set on it through the cooling surface, and the coil fixing piece The side wall is provided with an annular pipeline groove, and the pipeline groove is used to accommodate the cooling pipe; the bottom plate is connected to the end face of the coil fixing piece away from the refrigeration unit, and is used to form an accommodation cavity covered with thermally conductive fasteners. Thermal conductive fasteners are sleeved on the end of the Stirling cold head away from the refrigeration unit. They are used to connect the coil fixing part and the Stirling cold head and conduct heat transfer. The thermal conductive fasteners include a barrel-shaped body, and the inner diameter of the barrel-shaped body The surface that is adjustable and matches the cooling surface includes a through hole, which is used to surround and fix the end of the Stirling cold head away from the refrigeration unit, so that the cooling pipe in the pipeline groove contacts the cooling surface through the through hole. The temperature detection component is disposed on the surface of the base plate away from the thermally conductive fasteners for detecting real-time temperature values; the heating component is disposed on the surface of the baseplate away from the thermally conductive fasteners; the controller is electrically connected to the temperature detection component and the heating component for use in When the real-time temperature value is lower than the preset phase change threshold, the heating component is controlled to heat so that the real-time temperature value is within the preset safe ablation range; the controller is also electrically connected to the refrigeration unit, and the controller can be configured as: In the initial stage of refrigeration, the refrigeration unit is controlled to rapidly cool down at the preset full-load power; from any moment in the first preset time before cryoablation to the end of cryoablation, the temperature detection component is controlled to detect the real-time temperature value of the coil fixing part. The proportional integral differential algorithm is used to control the real-time temperature value within the preset safe ablation range. In this cryoablation system, the controller in the refrigeration device can obtain the real-time temperature value of the bottom plate through the temperature detection component, that is, the approximate real-time temperature value of the refrigerant, and when the real-time temperature value is lower than the preset phase change threshold of the refrigerant When , the heating component is controlled to heat the bottom plate to achieve the purpose of heating the refrigerant, so that the actual temperature of the refrigerant can be maintained within the preset safe ablation range. Through this setting, the temperature of the center of the cryoablation balloon during the ablation process can be within The cooling rate provided by the patient site is better, thereby ensuring that the doctor can complete the operation better and safer. Furthermore, the controller can also control the refrigeration unit to rapidly cool down at the preset full load power during the initial stage of refrigeration to ensure that when ablation begins, the refrigeration unit can quickly cool down the refrigerant to provide the best temperature for the operation. state, and the controller controls the temperature detection component to detect the real-time temperature value of the coil fixture during the period from any moment within the first preset time before freezing and ablation to the end of freezing and ablation. When the real-time temperature value is lower than When the phase change threshold is preset, the heating component is controlled to heat so that the real-time temperature value is within the preset safe ablation range. Through this setting, while ensuring that the refrigerant remains low, the cooling tube is prevented from being blocked, making the operation possible. Better and safer finish.

A third aspect of the present application provides a cryoablation temperature control method for cooling a refrigerant used for cryoablation. The method includes: controlling a refrigeration unit to control a cooling tube on a coil fixing member via a Stirling cold head. To cool down, the coil fixture is connected to the cooling surface of the Stirling cold head; the real-time temperature value of the cooling pipe is obtained, and when the real-time temperature value is lower than the preset phase change threshold, the heating component is controlled to heat so that the real-time temperature value is within Within the preset safe ablation range, the heating component is installed on the coil fixture.

In one embodiment, the method further includes: in the refrigeration initial stage, controlling the refrigeration unit to quickly cool down at a preset full load power; from any time within the first preset time before cryoablation to the end of cryoablation , controlling the temperature detection component to detect the real-time temperature value of the coil fixture, and using a proportional-integral-derivative algorithm to control the real-time temperature value to be within a preset safe ablation range.

Description of drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings needed to be used in the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present application. Those of ordinary skill in the art can also obtain drawings of other embodiments based on these drawings without exerting creative efforts.

Figure 1 shows a schematic structural diagram of the assembled refrigeration device in an embodiment of the present application.

Figure 2 shows an exploded view of the structure of a refrigeration device in an embodiment of the present application.

FIG. 3 is a schematic structural diagram of a coil fixing member, a bottom plate and a heating assembly in a refrigeration device according to an embodiment of the present application.

Figure 4 shows a schematic structural diagram of a thermally conductive fastener in a refrigeration device according to an embodiment of the present application.

Figure 5 shows a schematic structural diagram of the coil fixing member, temperature detection component and heating component in the refrigeration device according to an embodiment of the present application.

Figure 6 shows a schematic module structure diagram of a controller in a refrigeration device in an embodiment of the present application.

Figure 7 shows a schematic module structure diagram of a controller in a refrigeration device in another embodiment of the present application.

Figure 8 shows a schematic module structure diagram of a controller in a refrigeration device in another embodiment of the present application.

FIG. 9 is a schematic diagram of the electrical structure of a controller in a refrigeration device according to an embodiment of the present application.

Figure 10 shows a schematic diagram of the principle of PID control in an embodiment of the present application.

Figure 11 shows a schematic structural diagram of a cryoablation system in an embodiment of the present application.

Figure 12 shows a schematic flow chart of a cryoablation temperature control method in an embodiment of the present application.

Figure 13 shows the relationship between the temperature of the cryoablation balloon and time when the refrigeration device in one embodiment of the present application and the traditional refrigeration device using an ordinary compressor with a working fluid of R134a respectively control the temperature of the cryoablation balloon to decrease. Comparison chart.

Figure 14 shows the air intake of the cryoablation balloon when the temperature of the cryoablation balloon is controlled to drop to the same temperature using the refrigeration device in one embodiment of the present application and the traditional refrigeration device using an ordinary compressor with a working fluid of R134a. Comparison graph of pressure versus time.

Detailed ways

In order to facilitate understanding of the present application, the present application will be described more fully below with reference to the relevant drawings. The preferred embodiments of the present application are shown in the accompanying drawings. However, the present application may be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that a thorough understanding of the disclosure of the present application will be provided.

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

Where "includes," "has," and "includes" are used herein, another component may also be added unless an explicit qualifying term is used, such as "only," "consisting of," etc. . Unless mentioned to the contrary, terms in the singular may include the plural and shall not be construed as being one in number.

It should be noted that when an element is said to be "connected" to another element, it can be directly connected to the other element, or connected to the other element through an intervening element. In addition, "connection" in the following embodiments, if there is the transmission of electrical signals or data between the connected objects, should be understood as "electrical connection", "communication connection", etc., and "remote" described in this article only means It is to express the relative position characteristics and does not mean the actual distance. For example, "the end face connection between the bottom plate and the coil fixing part away from the refrigeration unit" means that the coil fixing part has two opposite end faces, one end face is opposite to the other. The end face is further away from the refrigeration unit, and the bottom plate is arranged on this end face.

The traditional refrigeration device included in the existing cryoablation system often cannot effectively control the temperature of the cryoablation balloon, and the cooling speed and safety control are poor.

This application aims to provide a refrigeration device that can achieve precise control of the temperature of the refrigerant in the cryo-ablation system and further improve safety.

As shown in Figure 1, in one embodiment of the present application, a refrigeration device is provided. The refrigeration device is used to cool down the cooling tube that delivers refrigerant to the cryoablation balloon. The refrigeration device includes: a refrigeration unit 100, a sterilizer Stirling cold head 200, fixed parts and cooling pipe 400, the refrigeration unit 100 is used for refrigeration, and the Stirling cold head 200 is connected to the refrigeration unit 100; in this embodiment, the fixed parts include a coil fixing part 300, a coil fixing part 300 is connected to the cooling surface of the Stirling cold head 200, and the Stirling cold head 200 realizes heat transfer through the cooling surface and the cooling pipe 400 provided on the coil fixing member 300.

Specifically, the cooling tube 400 is used to connect the cryoablation system. The inlet of the cooling tube 400 receives gaseous, liquid or gas-liquid two-phase refrigerant. After the refrigerant passes through the cooling tube 400, it is cooled by the refrigeration function of the refrigeration unit 100. After being fully liquefied, the outlet of the cooling pipe 400 outputs low-temperature liquid refrigerant to the patient's site.

By way of example, the refrigeration unit 100 is a refrigerator connected to the Stirling cold head 200 .

For example, the coil fixing member 300 may be a fixing ring, a fixing bracket, or the like.

As an example, a Stirling refrigerator is used for cooling and cooling. One end of the Stirling cold head 200 is fixedly mounted on the Stirling refrigerator. The cooling surface of the Stirling cold head 200 is the outer surface of the Stirling cold head 200 . surface, and the cooling surface of the Stirling cold head 200 is connected to the coil fixing part 300. The coil fixing part 300 is provided with a cooling pipe 400, and the Stirling cold head 200 The cooling surface realizes temperature exchange with the cooling pipe 400 through this arrangement, so as to reduce the temperature of the refrigerant flowing through the cooling pipe 400 .

At present, in cryoablation, ordinary compressors are basically used for refrigeration. Ordinary compressors are often used in household appliances such as air conditioners and refrigerators that we are familiar with. They have the advantages of low price and mature refrigeration technology. However, in cryoablation, In the medical field, a faster cooling rate is required. Ordinary compression cannot fully convert the refrigerant into a liquid state at a certain flow rate. According to the pressure-enthalpy diagram, a higher pressure needs to be increased to convert the refrigerant into a liquid state. From the perspective of surgical treatment, it is necessary to make the refrigerant temperature lower in a shorter period of time (the lower the temperature of the tissue in the first few tens of seconds, the better the effect). Combined with the cryoablation pipeline, ordinary compressors are more effective in refrigeration. Higher demands cannot be met.

Therefore, in this embodiment, a Stirling cold head is used in the cryoablation system, and the Stirling cold head is used to transfer energy, which not only increases the cooling rate of the ablation, but also reduces the inlet pressure of the cooling tube, thus Improves the efficiency and safety of surgery.

As shown in Figures 1 and 3, in one embodiment of the present application, the side wall of the coil fixing member 300 is provided with an annular pipeline groove 311, and the pipeline groove 311 is used to accommodate the cooling pipe 400; The pipe fixing member 300 is sleeved on the end of the Stirling cold head 200 away from the refrigeration unit 100, so that the cooling pipe 400 in the pipe groove 311 and the cooling surface can realize heat transfer.

Specifically, the coil fixing part 300 is sleeved on the end of the Stirling cold head 200 away from the refrigeration unit 100, and the outer wall of the coil fixing part 300 is recessed inward to form an annular pipeline groove 311, around which the cooling pipe 400 is formed. It is located in the pipeline groove 311 and connected to the bottom of the pipeline groove 311. The bottom of the pipeline groove 311 is spaced between the cooling pipe 400 and the cooling surface of the Stirling cold head 200, and the cooling pipe 400 circulates The refrigerant and the cooling surface of the Stirling cold head 200 perform indirect heat exchange through the bottom of the pipeline groove 311. In another feasible embodiment, the coil fixing member 300 includes two annular bodies, and The first annular body, the cooling pipe 400 and the second annular body are sequentially connected into one body by welding. At this time, the refrigerant circulating in the cooling pipe 400 and the cooling surface of the Stirling cold head 200 can be directly connected. For heat exchange, the refrigeration unit 100 directly cools the cooling pipes arranged in the pipe groove 311 through the cooling surface of the Stirling cold head 200 .

Specifically, the cooling pipe 400 is welded into the pipe groove 311 through a vacuum welding process to ensure a seamless connection between the cooling pipe 400 and the coil fixing member 300 .

In this embodiment, the cooling pipe 400 is embedded in the pipeline groove 311 on the side wall of the coil fixing part 300, and is welded to the pipeline groove 311 through a vacuum welding process, thereby improving the coil fixing part 300. The degree of integration, and through this arrangement, the cooling pipe 400 can more directly utilize the energy of the Stirling cold head 200, and the cooling pipe 400 can more fully absorb the cooling surface of the refrigeration unit 100 through the Stirling cold head 200 energy transferred.

As shown in Figures 1 and 4, in one embodiment of the present application, the fixing component also includes a thermally conductive fastener 500. The thermally conductive fastener 500 is sleeved on the end of the Stirling cold head 200 away from the refrigeration unit 100. The coil fixing part 300 and the Stirling cold head 200 are connected to perform temperature conduction.

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

Considering that the coil fixture provided with the cooling tube is directly connected to the cold head of the refrigeration unit, during actual use, due to the vibration of the refrigeration unit 100 during refrigeration operation, the coil fixture directly connected to the cold head It may become loose, which will cause the refrigeration device to malfunction, causing the cryoablation system to be unable to perform normal refrigeration. In severe cases, it may cause the doctor to fail the operation.

Therefore, in this embodiment, the thermally conductive fastener 500 is used to connect the coil fixing part 300 and the Stirling cold head 200, so that the connection between the coil fixing part 300 and the Stirling cold head 200 is stronger and the coil is fixed. The component 300 will not loosen from the Stirling cold head 200 due to vibration generated during actual use, ensuring the firmness of the connection of components in the refrigeration device in this embodiment. Moreover, the thermally conductive fastener 500 has strong thermal conductivity and can better realize the energy exchange between the Stirling cold head 200 and the coil fixing piece 300 .

As shown in Figure 5, in one embodiment of the present application, the refrigeration device also includes a bottom plate 310. The bottom plate 310 is connected to the end surface of the coil fixing part 300 away from the refrigeration unit 100, and together with the coil fixing part 300, forms a covered heat-conducting tight fitting. accommodating cavity of the fastener 500; the refrigeration device also includes a temperature detection component 600. The temperature detection component 600 is disposed on the surface of the bottom plate 310 away from the thermally conductive fastener 500 for detecting real-time temperature values.

Specifically, the temperature detection component 600 may be an infrared temperature sensor, a radiation thermometer, a thermocouple, a thermal resistor, or other temperature measuring instrument.

As an example, the coil fixing member 300 and the bottom plate 310 can be integrally formed to form a cover-like component with a receiving cavity. When the fastener 500 is connected, the cover-like component can cover the thermally conductive fastener 500, which is equivalent to the cover-like component covering the end of the Stirling cold head 200 away from the refrigeration unit 100, and the temperature detection component 600 can be used. The thermocouple is disposed on the surface of the bottom plate 310 away from the heat-conducting fastener 500 and can detect the temperature of the bottom plate 310. Since the bottom plate 310 and the coil fixing part 300 are integrally formed and the coil fixing part 300 and the cooling pipe 400 are welded. As a whole, it can be considered that the temperature detection component 600 detects the temperature of the cooling pipe 400 , that is, the temperature of the refrigerant in the cooling pipe 400 .

As shown in FIG. 2 , in this embodiment, a bottom plate 310 is provided at an end of the coil fixing part 300 away from the refrigeration unit 100 , so that when the coil fixing part 300 is connected to the thermally conductive fastener 500 , the bottom plate 310 and the coil The cover-like component formed by the tube fastener 300 can cover at least most of the structure of the thermally conductive fastener 500. This arrangement can make the various components of the refrigeration device in this embodiment occupy a smaller space after being combined, and the degree of integration is high. Higher, it also makes the assembled refrigeration device more beautiful. A temperature detection component 600 is also provided on the surface of the bottom plate 310 away from the thermally conductive fastener 500, thereby realizing real-time temperature detection of the cooling pipe 400 provided on the coil fixing member 300. Through the temperature detection component 600, one can intuitively understand The actual effect of the refrigeration device in this embodiment on refrigerating the refrigerant in the cooling pipe 400.

As shown in Figure 4, in one embodiment of the present application, the thermally conductive fastener 500 includes a barrel body 510. The inner diameter of the barrel body 510 is adjustable and the surface matching the cooling surface includes a through hole 520. The barrel body 510 is used for Surrounded and fixed on the end of the Stirling cold head 200 away from the refrigeration unit 100, the coil fixing member 300 is sleeved on the barrel body 510, so that the cooling pipe 400 in the pipeline groove 311 passes through the inner wall and cooling surface of the through hole 520. Indirect connection enables energy transfer. At the same time, the distal surface of the Stirling cold head 200 can also be in contact with the inner surface of the base plate 310 to achieve energy transfer.

Specifically, the barrel body 510 may be of an open-loop design, and a nut is used to realize the closed-loop connection of the barrel body 510 . The tightness of the nut determines the inner diameter of the barrel body 510 . That is, the barrel body 510 may include one or two C-shaped structures, and have one or two openings and corresponding fastening structures and nuts provided at the openings. Through the cooperation of the nuts and the fastening structures, it can Adjust the size of the opening to adjust the inner diameter of the barrel body 510 .

As shown in Figure 3, correspondingly, the coil fixing part 300 is provided with at least one notch 312 on the other side relative to the bottom plate 310. When the coil fixing part 300 is connected to the thermally conductive fastener 500, the position of the notch 312 is consistent with The positions of the fastening structure and the nut on the barrel body 510 match each other. Through this arrangement, the assembled refrigeration device in this embodiment is more beautiful and occupies a smaller volume.

Preferably, a heat conduction layer can be provided between the barrel body 510 and the Stirling cold head 200. The heat conduction layer can use thermal conductive silicone grease to fill the gap between the cooling surface of the Stirling cold head 200 and the barrel body 510. This reduces losses during temperature transfer.

As shown in Figure 4, in this embodiment, the inner diameter of the barrel body 510 can be adjusted accordingly 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 body 510. The cooling surface of the Trine cold head 200 can be seamlessly attached to the barrel body 510. The adjustable inner diameter design allows the thermal conductive fastener 500 to be suitable for cold heads of different sizes, and has higher versatility. When the coil fixing piece 300 After the size is determined, even if different specifications of Stirling cold head 200 are used, the coil fixing part 300 and Stirling cold head 200 can be firmly connected by adjusting the size of the thermally conductive fastener 500; and the barrel body 510 is provided with a through hole 520, which allows the Stirling cold head 200 in this embodiment to pass through the through hole 520 and directly contact the coil fixing member 300, and the energy of the Stirling cold head 200 can be directly transferred to the coil The fixing part 300 does not need to pass through the thermally conductive fastener 500. This arrangement reduces the loss during energy transmission and improves the refrigeration efficiency of the refrigeration unit 100.

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

Specifically, the thermal conductive layer may be aluminum nitride coating, boron nitride coating, aluminum oxide coating or thermal conductive silicone grease coating, etc. Coating with better thermal properties.

As an example, thermally conductive silicone grease can be used as the thermal conductive layer and evenly coated between the mating surfaces of the coil fixing part 300 and the barrel body to fill the gap between the coil fixing part 300 and the barrel body 510 so that the temperature Loss during transmission is reduced.

As shown in Figures 1, 5 and 6, in one embodiment of the present application, the refrigeration device further includes a heating component 700 and a controller 800. The heating component 700 is disposed on the surface of the bottom plate 310 away from the thermally conductive fastener 500; control The device 800 is electrically connected to the temperature detection component 600 and the heating component 700, and is used to control the heating of the heating component 700 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 phase change threshold. Within the safe ablation range.

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

Although in this embodiment, the heating component 700 is disposed on the bottom plate 310, those skilled in the art will understand that the heating component 700 can also be disposed on the coil fixing member 300, and the present invention is not limited thereto.

The preset safe ablation range refers to the temperature range set in advance by the user based on the actual refrigerant used. As an example, the refrigerant in the cooling pipe 400 is laughing gas, and the critical temperature of laughing gas is -89°C. When the refrigeration device is used for cooling When the refrigerant in the tube 400 is cooled so that the temperature of the laughing gas is lower than -89°C, the laughing gas will undergo a phase change from a liquid/gas state to a solid state, causing the cooling tube 400 to become blocked. Therefore, in this embodiment, A preset safe ablation range with a minimum temperature greater than -89°C is set. The lowest value of the preset safe ablation range is the preset phase change threshold. For example, the preset safe ablation range can be [-80°C, -50°C], then the preset safe ablation range Assume that the phase change threshold is -80°C. Within this range, the refrigerant can maintain a lower temperature, so that the cryoablation balloon can cool down faster at the patient site during the ablation process without phase change, causing the cooling tube to 400 blocked.

As an example, an electric heating sheet is used as the heating component 700. The electric heating sheet can be pasted on the surface of the base plate 310 away from the thermally conductive fastener 500. The electric heating sheet heats the coil fixing member 300 by heating the base plate 310, thereby heating the coil. The fixing part 300 is welded into an integrated cooling pipe 400 to achieve the purpose of heating the coolant. With this arrangement, the coolant can be heated by the electric heating plate when the temperature is lower than the preset phase change threshold.

In this embodiment, the heating component 700 is connected to the side of the base plate 310 away from the cooling unit 100. The controller 800 is electrically connected to the temperature detection component 600 and the heating component 700 respectively. The controller 800 can obtain real-time information of the base plate 310 through the temperature detection component 600. The temperature value is the real-time temperature value of the refrigerant. When the real-time temperature value is lower than the preset phase change threshold, the heating component 700 is controlled to heat the bottom plate 310 to achieve the purpose of heating the refrigerant so that the actual temperature of the refrigerant can be maintained at Within the preset safe ablation range, this setting can make the temperature of the cryoablation balloon provide a better cooling rate at the patient site during the ablation process, thus ensuring that doctors can complete the operation better and safer.

As shown in Figure 5, in one embodiment of the present application, the electric heating plate 700 has a plurality of clamping grooves 710; screw holes are provided on the contact end surfaces of the thermally conductive fastener 500 and the bottom plate 310, and the screw holes are evenly distributed on In the clamping groove 710; the coil fixing part 300 is connected to the thermally conductive fastener via bolts provided in the screw holes.

As an example, the electric heating plate may be in an X shape, and then the electric heating plate includes four clamping slots. The thermally conductive fastener 500 is provided with a screw hole at an end away from the refrigeration unit 100. The screw hole may be a blind hole or a through hole. The bottom plate 310 is provided with screw holes at corresponding positions. The screw holes on the bottom plate 310 can be through holes. The bolts pass through the screw holes on the bottom plate 310 and the thermally conductive fastener 500 in sequence to connect the bottom plate 310 and the thermally conductive fastener 500 as one body. , and since the bottom plate 310 is connected to the coil fastener 300, when the bottom plate 310 is connected to the thermally conductive fastener 500, the coil fastener 300 and the thermally conductive fastener 500 are also connected as one, and the nuts on the bolts are evenly distributed at this time. On the side of the bottom plate 310 away from the thermally conductive fastener 500, they are respectively located in the engaging grooves of the electric heating sheets.

Furthermore, if a thermocouple is used as the temperature detection component 600, in order to prevent the thermocouple from falling off the coil fixture 300 due to vibration during actual use, the thermocouple can be wound around the stud of any of the above bolts. When the bolt is screwed into the screw hole, the head of the bolt presses the thermocouple, and the thermocouple is fixed to the surface of the bottom plate 310 away from the thermally conductive fastener 500 .

In an optional embodiment, multiple thermocouples are used as the temperature detection component 600, and the multiple thermocouples are divided into The bolts are wound around the studs of the plurality of evenly distributed bolts, so that when the bolts are screwed to the screw holes, the nuts of the bolts cover the thermocouples and fix the thermocouples to the surface of the bottom plate 310 away from the thermally conductive fasteners 500. When the controller 800 can obtain the temperature values detected by multiple thermocouples, the multiple temperature values will be averaged, and the average value will be used as the final real-time temperature value to eliminate errors caused by different locations of the thermocouple distribution. If there is an error in the detected temperature, through this setting, a real-time temperature value with a smaller error from the actual temperature can be obtained, thereby achieving precise control of the temperature of the refrigerant by the refrigeration device in this 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 as:

In the initial stage of refrigeration, the refrigeration unit 100 is controlled to rapidly cool down with preset full load power;

From any moment within the first preset time before cryoablation to the end of cryoablation, the temperature detection component 600 is controlled to detect the real-time temperature value of the coil fixture 300, and a proportional integral differential algorithm is used to control the real-time temperature value to be within the preset safe ablation state. within the range.

The first preset time can be adjusted according to actual usage requirements. The first preset time can be 0s, which means that from the beginning of cryoablation, the controller 800 controls the temperature detection component 600 to detect the real-time temperature value of the coil fixture 300, and The proportional integral differential algorithm is used to control the real-time temperature value within the preset safe ablation range.

In actual surgery, the refrigeration device may need to wait for different periods of time after starting to cool before starting the surgery. At this time, the refrigeration device needs to maintain full cooling power to ensure that the refrigeration unit 100 can quickly cool down the refrigerant when ablation begins. However, due to The refrigerant will undergo a phase change at a certain low temperature, from gas/liquid state to solid state, causing the cooling pipe 400 to become blocked. Therefore, the temperature detection component 600 is controlled by the controller 800 to detect the real-time temperature value of the coil fixture 300. When the real-time temperature value When the phase change threshold is lower than the preset phase change threshold, the heating component 700 is controlled to heat so that the real-time temperature value is within the preset safe ablation range. Through this setting, the cooling tube 400 is prevented from clogging while ensuring that the refrigerant remains low. .

Specifically, based on the real-time temperature value, an incremental PD control algorithm or an incremental PID control algorithm can be used to control the actual temperature value to be within a preset safe ablation range.

In this embodiment, the controller 800 can control the refrigeration unit 100 to quickly cool down at the preset full-load power during the initial cooling stage, so that the temperature of the cryoablation balloon can drop quickly, thereby providing the best temperature state for the operation, and During the period from any moment within the first preset time before cryoablation to the end of cryoablation, the temperature detection component 600 is controlled to detect the real-time temperature value of the coil fixture 300, and uses a proportional integral differential algorithm to control the real-time temperature value. is within the preset safe ablation range, so that when cryoablation starts, the real-time temperature value detected by the temperature detection component 600 can be just within the preset safe ablation range, and the refrigerant provides a lower temperature for the cryoablation balloon. It can avoid clogging of the cooling tube 400, ensuring the good operation of the refrigeration device, allowing the operation to be performed better, without causing the operation because the temperature provided by the cryoablation balloon is not low enough or the cooling tube 400 in the refrigeration device is blocked. Prolonged.

As shown in Figure 8, in one embodiment of the present application, the refrigeration device also includes an interactive unit 900. The interactive unit 900 is electrically connected to the controller 800 and is used to display real-time temperature values; and/or obtain the presets set by the user. Safe ablation range.

Specifically, the interaction unit 900 is a graphical user interface (GUI) provided on a terminal. The terminal here can be, but is not limited to, various personal computers, laptops, smart phones, tablets, Internet of Things devices, and Portable wearable devices, IoT devices can be smart TVs, smart car devices, etc. Portable wearable devices can be smart watches, smart bracelets, head-mounted devices, etc.

Further, in the refrigeration device in the above embodiment, the user can set the preset safe ablation range, the start time of cryoablation and the first preset time through the interactive unit 900, then the controller 800 will set the preset time before the start time of cryoablation. From the first preset time to the end of cryoablation, the temperature detection component 600 is continuously controlled to detect the real-time temperature value of the coil fixture 300. At this time, the user can also obtain the temperature value detected by the temperature detection component 600 through the interactive unit 900. The controller 800 also obtains the preset safe ablation range through the interactive unit 900 and determines whether the real-time temperature value is lower than the preset phase change threshold. If so, the proportional integral differential algorithm is used to control the heating component 700 The bottom plate 310 is heated to achieve the purpose of heating the refrigerant so that the actual temperature of the refrigerant can be maintained within a preset safe ablation range. Through this setting, the temperature of the balloon center during the ablation process can be provided with a cooling rate at the patient site. Better, thus ensuring that doctors can complete operations better and safer.

In one embodiment of the present application, the interaction unit 900 can also be used to obtain a preset detection frequency.

For example, the preset detection frequency refers to the frequency at which the temperature detection component 600 detects the coil fixture 300 .

In the refrigeration device in the above embodiment, the user can set the preset detection frequency, the preset safe ablation range, the start time of cryoablation and the first preset time through the interactive unit 900, then the controller 800 will set the preset detection frequency at the start time of cryoablation. From the previous first preset time to the end of cryoablation, the temperature detection component 600 is continuously controlled to detect the real-time temperature value of the coil fixture 300 according to the preset detection frequency. At this time, the user can also use the interactive unit 900 Obtain the real-time temperature value detected by the temperature detection component 600. The controller 800 also obtains the preset safe ablation range through the interactive unit 900, and determines whether the real-time temperature value is lower than the preset phase change threshold. If so, the proportional integral differential algorithm is used for control. The heating assembly 700 heats the bottom plate 310 to achieve the purpose of heating the refrigerant so that the actual temperature of the refrigerant can be maintained within a preset safe ablation range. Through this setting, the temperature of the center of the balloon can be provided at the patient site during the ablation process. The cooling rate is better, thus ensuring that doctors can complete the operation better and safer.

As an example, as shown in Figure 9, the electrical structure diagram of the controller 800 in this embodiment is shown. The controller 800 includes a microcontroller unit (Microcontroller Unit, MCU), an analog-to-digital converter (Analogical Digital, AD), and a graphical user interface. Interface (Graphical User Interface, GUI), amplifier and drive circuit. In the actual control process, the user can set/change the preset safe ablation range through the GUI before or during the ablation process. In the initial stage of cooling, the MCU The refrigeration unit 100 is controlled to rapidly cool down at a preset full load power, and the temperature detection component 600 collects a simulation of the temperature of the coil fixture 300 during a period starting from any time within the first preset time before cryoablation to the end of cryoablation. signal, the MCU converts the analog signal into a digital signal through AD, and converts the digital signal into the corresponding temperature, that is, the 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 the preset At the phase change threshold, the proportional integral differential algorithm is used to calculate the target digital signal, and the target digital signal is converted into the target analog signal through a digital-to-analog converter (Digital Analogical, DA). The DA then amplifies the target analog signal through the amplifier method. The final signal is input to the driving circuit, and the driving circuit then applies the signal to the heating component 700, thereby realizing the heating of the coil fixing part 300 by the heating component 700.

As an example, the controller 800 uses a PID controller and uses a proportional integral differential algorithm to control the real-time temperature value to be within the preset safe ablation range, as shown in Figure 10. In the PID control schematic diagram, r(t) is the preset safe ablation range. The temperature value within the range, for example, can be the lowest temperature value within the preset safe ablation range, y(t) is the actual temperature value, and the temperature value within the preset safe ablation range and the actual temperature value constitute the control deviation e(t) , e(t)=r(t)-y(t), then e(t) serves as the input of the PID controller, and y(t) serves as the output of the PID controller and the input of the controlled variable.

Proportional (P) control can quickly respond to errors and play a greater role when the error is large. However, proportional control cannot eliminate steady-state errors. The increase in the proportional coefficient will cause system instability. The function of integral (I) control is: as long as there is an error in the system, the integral will continue to accumulate and the control amount will be output to eliminate the error. As long as there is enough time, integral control will completely eliminate the error and bring the system error close to zero, thus eliminating the steady-state error. However, excessive integral effect will increase the overshoot of the system and even cause the system to oscillate. Differential (D) control can reduce overshoot, overcome oscillation, improve the stability of the system, speed up the dynamic response speed of the system, reduce the adjustment time, thereby improving the dynamic performance of the system. According to the control characteristics of different controlled objects, it can be divided into different control models such as P, PI, PD, and PID. Temperature control commonly uses proportional differential (Proportion Differentiation, PD) and proportional integral differential (Proportion Integration Differentiation, PID). PID two methods.

The PID control schematic diagram simulates the PID formula:

In the above formula, u(t) is the output signal of PID control, and e(t) is the temperature value and the actual temperature within the preset safe ablation range. The value constitutes the control deviation, K _p represents the proportional coefficient, T _l represents the integral time, T _D represents the differential time, u (0) is the control constant, and t is the time constant. Discretize the above PID formula: replace integral with summation, replace differential with increment, and make the following transformation in (1-1):
t≈kT k∈[1,N] (1-2)

In the above formula, T is the sampling period, j and k are the sampling sequence numbers, N is the total number of samples, t is the time constant, corresponding to kT, and e _t and e _t-1 represent the deviation values of two consecutive times.

From formula (1-2), formula (1-3) and formula (1-4), the discrete expression (1-5) can be obtained:

The incremental PID formula is derived from the above formula (1-5):

e _t =r(t)-y(t)(1-7)

In the above formula, Δu _k is the increment of the control quantity, K _p is the proportional coefficient, _Ti is the integral parameter, Td is the differential parameter, e _k , e _k-1 and e _k-2 are the deviations of three consecutive sampling values respectively. , T represents the sampling period. For the PID controller, sampling is the input and control is the output. The sampling period is usually regarded as the control period. The control period of the heating component 700 needs to be determined according to the actual response, and the control period can range from 500ms to 2s.

If the heating component 700 is controlled to heat the coil fixture 300 so that the actual temperature value detected by the temperature detection component 600 can reach the preset safe ablation range, it is necessary to control whether the heating component 700 does work, that is, to control the heating power of the heating component 700 is 0 or greater than 0, thereby achieving precise control of the refrigerant temperature so that the temperature of the refrigerant can be maintained within the preset safe ablation range.

Further, in one embodiment of the present application, a cryoablation system is provided, including a cryoablation balloon 15, a solenoid valve 16 and the above-mentioned refrigeration device. The cryoablation balloon 15 is used to achieve refrigeration flowing through the cryoablation balloon. The solenoid valve 16 is provided in the exhaust passage of the cryoablation balloon to control the flow of refrigerant within the preset safe flow threshold range. The refrigeration device includes a refrigeration unit 100, a Stirling cold head 200, a coil fixture 300, a cooling pipe 400, a thermally conductive fastener 500, a temperature detection component 600, a heating component 700, a controller 800 and an interactive unit 900. The refrigeration unit 100 is used for refrigeration, the Stirling cold head 200 is connected to the refrigeration unit 100; the coil fixing part 300 is connected to the cooling surface of the Stirling cold head 200, and the Stirling cold head 200 is connected to the coil fixing part 300 via the cooling surface. The cooling pipe 400 is provided to realize heat transfer. The side wall of the coil fixing part 300 is provided with an annular pipeline groove 311. The pipeline groove 311 is used to accommodate the cooling pipe 400; the bottom plate 310 and the coil fixing part 300 are away from the refrigeration The end faces of the units 100 are connected to form a receiving cavity covering the thermally conductive fastener 500 . The thermally conductive fastener 500 is sleeved on the end of the Stirling cold head 200 away from the refrigeration unit 100 and is used to connect the coil fixing part 300 and the Stirling cold head 200 and conduct temperature conduction. The thermally conductive fastener 500 includes: barrel-shaped The body has an adjustable inner diameter and a bottom surface including a through hole, which is used to surround and fix the end of the Stirling cold head 200 away from the refrigeration unit 100, so that the cooling pipe 400 in the pipeline groove 311 contacts the cooling surface through the through hole. The temperature detection component 600 is disposed on the surface of the base plate 310 away from the thermally conductive fastener 500 for detecting the real-time temperature value; the heating component 700 is disposed on the surface of the base plate 310 away from the thermally conductive fastener 500; the controller 800, the temperature detection component 600 and the heating element The thermal components 700 are all electrically connected, and are used to control the heating of the heating component 700 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; the controller 800 also communicates with the refrigeration unit 100 Electrically connected, the controller 800 can be configured to: in the initial stage of refrigeration, control the refrigeration unit 100 to quickly cool down with the preset full load power; and from any time within the first preset time before cryoablation to the end of cryoablation, control the temperature The detection component 600 detects the real-time temperature value of the coil fixture 300, and uses a proportional integral differential algorithm to control the real-time temperature value to be within a preset safe ablation range.

As shown in Figure 11, as an example, the cryoablation system in this embodiment includes a refrigerant storage tank 11, a pressure reducing valve 12, a high pressure proportional valve 13, the above-mentioned refrigeration device 14, a cryoablation balloon 15, and a solenoid valve connected in sequence. 16. Vacuum pump 17, flow meter 18 and return air reserve device 19. The refrigerant storage tank 11, pressure reducing valve 12, high pressure proportional valve 13 and refrigeration device 14 are located in the liquid supply path of the cryoablation balloon 15. The refrigerant The storage tank 11 is used to store refrigerant; the pressure reducing valve 12 and the high-pressure proportional valve 13 are used to control the air pressure value of the refrigerant in the liquid supply path of the cryoablation balloon 15; the refrigeration device 14 is used to accurately control the temperature of the refrigerant; the solenoid valve 16. The vacuum pump 17, the flow meter 18 and the return air reserve device 19 are located in the exhaust passage of the cryoablation balloon 15. The solenoid valve 16 is used to control the flow of refrigerant within the preset safe flow threshold range; the vacuum pump 17 is used to The refrigerant in the cryoablation balloon is sucked out; the flow meter 18 is used to obtain the real-time flow rate of the refrigerant; the return air reserve device 19 is used to recover the refrigerant. Among them, a one-way valve is also provided between the refrigerant storage tank 11 and the pressure reducing valve 12 for controlling the one-way flow of refrigerant in the liquid supply passage of the cryoablation balloon 15. The pressure reducing valve 12 and the high-pressure proportional valve 13 A pressure gauge is disposed between the cryoablation balloon 15 for controlling the flow of refrigerant in the liquid supply path of the cryoablation balloon 15. A pressure sensor is disposed between the high-pressure proportional valve 13 and the refrigeration device 14 for obtaining the flow of refrigerant in the cryoablation balloon 15 liquid supply path. The real-time pressure value of the refrigerant; a pressure sensor is provided between the cryoablation balloon 15 and the solenoid valve 16 to obtain the real-time pressure value of the refrigerant in the exhaust passage of the cryoablation balloon 15, and a low-pressure sensor is provided in parallel with the solenoid valve 16 A proportional valve is used to control the pressure value of the refrigerant in the exhaust passage of the cryoablation balloon 15. A one-way valve is provided between the solenoid valve 16 and the vacuum pump 17 to control the pressure of the refrigerant in the exhaust passage of the cryoablation balloon 15. One-way flow.

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 through the temperature detection component 600, that is, the approximate real-time temperature value of the refrigerant, and calculate the real-time temperature value at the real-time temperature value. When the value is lower than the preset phase change threshold of the refrigerant, the heating assembly 700 is controlled to heat the bottom plate 310 to achieve the purpose of heating the refrigerant, so that the actual temperature of the refrigerant can be maintained within the preset safe ablation range. Through this setting, It can make the temperature at the center of the cryoablation balloon provide a better cooling rate at the patient's site during the ablation process, thereby ensuring that doctors can complete the operation better and safer.

Furthermore, in the cryoablation system in the above embodiment, the controller 800 in the refrigeration device 14 can also control the refrigeration unit 100 to rapidly cool down at the preset full load power during the initial stage of refrigeration to ensure that the refrigeration is The unit 100 can quickly cool down the refrigerant to provide the best temperature state for the operation, and the controller 800 starts at any time within the first preset time before cryoablation to the end of the cryoablation. The temperature detection component 600 is controlled to detect the real-time temperature value of the coil fixture 300. When the real-time temperature value is lower than the preset phase change threshold, the heating component 700 is controlled to heat so that the real-time temperature value is within the preset safe ablation range. This arrangement prevents the cooling pipe 400 from being blocked while ensuring that the refrigerant remains at a low temperature, allowing the surgery to be completed better and safer.

As shown in Figure 12, further, in one embodiment of the present application, a cryoablation temperature control method is provided for cooling the cooling tube that delivers refrigerant to the cryoablation balloon. The method includes:

Step 202: Control the refrigeration unit 100 to cool down the cooling pipe 400 on the coil fixture 300 through the Stirling cold head 200. The coil fixture 300 is connected to the cooling surface of the Stirling cold head 200;

Step 204: Obtain the real-time temperature value of the cooling tube 400. When the real-time temperature value is lower than the preset phase change threshold, control the heating component 700 to heat so that the real-time temperature value is within the preset safe ablation range. The heating component 700 is set at Coil fastener 300.

As an example, the controller 800 is used to control the refrigeration unit 100 to cool down the cooling pipe 400 on the coil fixture 300 via the Stirling cold head 200. The controller 800 is configured, for example, to: in the initial stage of cooling, control the refrigeration unit 100 to The full load power is preset for rapid cooling to ensure that when ablation begins, the refrigeration unit 100 can quickly cool down the refrigerant, thereby providing the best temperature state for the operation.

Further, the coil fixing part 300 can be connected to the Stirling cold head 200 using a thermally conductive fastener 500, wherein the thermally conductive fastener 500 is sleeved on an end of the Stirling cold head 200 away from the refrigeration unit 100, so that the coil The connection between the fixing part 300 and the Stirling cold head 200 is stronger. The coil fixing part 300 will not loosen from the Stirling cold head 200 due to vibration generated during actual use, ensuring a firm connection of the components in the refrigeration device. sex. Moreover, the thermally conductive fastener 500 can be made of copper, which has strong thermal conductivity and can better realize energy exchange between the Stirling cold head 200 and the coil fixing piece 300 .

As an example, the temperature detection component 600 is used to obtain the real-time temperature value of the cooling tube 400, and the preset phase change threshold and the preset safe ablation range are set according to the critical temperature of the actually used refrigerant 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 component 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 detection component 600 to obtain the real-time temperature value of the cooling pipe 400 at a preset frequency, and set a preset phase change threshold and a preset safe ablation range according to the critical temperature of the actually used refrigerant, and When the real-time temperature value is lower than the preset phase change threshold, the heating component 700 is controlled to heat so that the real-time temperature value is within the preset safe ablation range.

Further, the interactive unit 900 is used to obtain the preset frequency, the preset phase change threshold and the preset safe ablation range input by the user, and then the controller 800 controls the temperature detection component 600 to detect the real-time temperature of the coil fixture 300 according to the preset detection frequency. value, the controller 800 also obtains the preset safe ablation range through the interactive unit 900, and determines whether the real-time temperature value is lower than the preset phase change threshold. If so, the proportional integral differential algorithm is used to control the heating component 700 to heat the bottom plate 310 to achieve heating. The purpose of the refrigerant is to keep the actual temperature of the refrigerant within the preset safe ablation range. Through this setting, the temperature of the balloon center during the ablation process can provide a better cooling rate at the patient site, thereby ensuring that the doctor The operation can be completed better and safer.

Further, the interactive unit 900 is used to obtain the start time of cryoablation and the first preset time input by the user, then the controller 800 starts at the first preset time before the start time of cryoablation, and ends the period from the start time of cryoablation to the end of cryoablation. Within the time, the temperature detection component 600 is continuously controlled to detect the real-time temperature value of the coil fixture 300 according to the preset detection frequency. The controller 800 also obtains the preset safe ablation range through the interaction unit 900 and determines whether the real-time temperature value is lower than the preset value. phase change threshold, if so, the proportional integral differential algorithm is used to control the heating component 700 to heat the bottom plate 310 to achieve the purpose of heating the refrigerant, so that the actual temperature of the refrigerant can be maintained within the preset safe ablation range. Through this setting, it can This allows the temperature at the center of the balloon to provide a better cooling rate at the patient site during the ablation process, thereby ensuring that the doctor can complete the operation better and safer.

Specifically, the heating assembly 700 uses an electric heating sheet. The electric heating sheet can be pasted on the coil fixing part 300, and the electric heating sheet heats the refrigerant through the heating coil fixing part 300, so that the actual temperature of the refrigerant can be maintained at a predetermined value. Within the safe ablation range.

It should be understood that although each step in the flowchart of FIG. 12 is shown in sequence as indicated by the arrows, these steps are not necessarily executed in the order indicated by the arrows. Unless explicitly stated in this article, there is no strict order restriction on the execution of these steps, and these steps can be executed in other orders. Moreover, at least some of the steps in Figure 12 may include multiple sub-steps or multiple stages. These sub-steps or stages are not necessarily executed at the same time, but may be executed at different times. The execution of these sub-steps or stages The sequence is not necessarily sequential, but may be performed in turn or alternately with other steps or sub-steps of other steps or at least part of the stages.

As shown in Figure 13, it can be seen through experiments that using the refrigeration device provided in the embodiment of the present application and the traditional refrigeration device using an ordinary compressor with a working fluid of R134a, after the same time of refrigeration, using the refrigeration device provided in the embodiment of the present application. The refrigeration device obviously cools down faster and the cryoballoon temperature is lower; using the refrigeration device provided in the embodiment of the present application and the traditional refrigeration device, the comparison chart of the inlet pressure generated by the cryoablation balloon is shown in Figure 14. Experiment show that in When the temperature of the cryoballoon is reduced to the same temperature, the air inlet pressure caused by the refrigeration device provided in the embodiment of the present application to the cryoablation balloon is nearly 70 psi lower than the air inlet pressure caused by the traditional refrigeration device to the cryoablation balloon. After After multiple tests, it was found that the inlet pressure difference can have a maximum difference of 100 psi, which provides safer protection to prevent the cryoablation balloon from rupturing due to excessive pressure. It is clear that the inlet pressure value that the refrigeration device provided in this application can reduce is not limited to less than 100 psi. For different refrigerants, the inlet pressure value that this application can reduce is also different.

The technical features of the above embodiments can be combined in any way. To simplify the description, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, All should be considered to be within the scope of this manual.

The above-described embodiments only express several implementation modes of the present application, and their descriptions are relatively specific and detailed, but they should not be construed as limiting the scope of the patent application. It should be noted that, for those of ordinary skill in the art, several modifications and improvements can be made without departing from the concept of the present application, and these all fall within the protection scope of the present application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims (20)

A refrigeration device, characterized by including: refrigeration unit; Stirling cold head, connected to the refrigeration unit; A fixed component connected to the cooling surface of the Stirling cold head; A cooling tube is provided on the fixed component for cooling the refrigerant used for cryoablation. The Stirling cold head cools the cooling tube provided on the fixed component through the cooling surface. The refrigeration device according to claim 1, wherein the fixing component includes a coil fixing piece, a side wall of the coil fixing piece is provided with an annular pipeline groove, and the pipeline groove is used for The cooling pipe is accommodated; the coil fixing member is sleeved on the Stirling cold head, so that the cooling pipe in the pipeline groove and the cooling surface can realize heat transfer. The refrigeration device according to claim 2, wherein the cooling pipe is welded into the pipeline groove through a vacuum welding process. The refrigeration device according to claim 2, further comprising: The bottom plate is connected to the end surface of the coil fixing member away from the refrigeration unit; A temperature detection component is provided on the surface of the bottom plate away from the refrigeration unit, and is used to detect real-time temperature values. The refrigeration device according to claim 4, further comprising: A heating component, arranged on the bottom plate or the coil fixture; A controller, electrically connected to both the temperature detection component and the heating component, for controlling the heating of the heating component when the real-time temperature value is lower than a preset phase change threshold, so that the real-time temperature value Within the preset safe ablation range. The refrigeration device according to claim 5, wherein the heating component includes an electric heating sheet attached to a surface of the base plate away from the refrigeration unit. The refrigeration device according to claim 6, characterized in that the electric heating plate is in an inside the tank. The refrigeration device according to claim 2, wherein the fixing component includes: Thermal conductive fasteners are sleeved on the Stirling cold head and used to connect the coil fixing part and the Stirling cold head and conduct heat transfer. The refrigeration device according to claim 8, further comprising a temperature detection component disposed on a surface of the bottom plate away from the refrigeration unit for detecting a real-time temperature value, and the temperature detection component includes a thermocouple. , is arranged on the surface of the bottom plate away from the thermally conductive fastening part; the coil fixing piece is sleeved on the thermally conductive fastener. The refrigeration device according to claim 9, characterized in that, screw holes are provided on the contact end surfaces of the thermally conductive fasteners and the bottom plate; and the coil fixing member is connected to the coil through bolts provided in the screw holes. Thermal conductive fasteners are connected; the thermocouple is wound around the stud of the bolt, so that when the bolt is screwed to the screw hole, the head of the bolt presses the thermocouple, and the The thermocouple is fixed on the surface of the base plate away from the thermally conductive fastener. The refrigeration device according to any one of claims 8-10, characterized in that the thermally conductive fastener includes: A barrel-shaped body, the inner diameter of the barrel-shaped body is adjustable and has a through hole matching the cooling surface, which is used to be fixed around the end of the Stirling cold head away from the refrigeration unit, so that the pipeline is concave The cooling pipe in the tank contacts the cooling surface through the through hole. The refrigeration device according to claim 11, further comprising: A heat conductive layer is provided between the mating surface of the coil fixing member and the barrel body. The refrigeration device according to claim 12, wherein the heat conductive layer includes: Thermal conductive silicone grease is evenly coated between the mating surface of the coil fixing part and the barrel body. The refrigeration device according to any one of claims 5-7, further comprising: An interactive unit, electrically connected to the controller, used to display the real-time temperature value; and/or Obtain the preset safe ablation range set by the user. The refrigeration device according to claim 14, wherein the preset safe ablation range is [-80°C, -50°C]. The refrigeration device according to any one of claims 5-7, characterized in that the controller is electrically connected to the refrigeration unit and is configured to: In the initial stage of refrigeration, control the refrigeration unit to rapidly cool down at preset full load power; From any moment within the first preset time before cryoablation to the end of cryoablation, the temperature detection component is controlled to detect the real-time temperature value of the coil fixture, and a proportional integral differential algorithm is used to control the real-time temperature value to be within Within the preset safe ablation range. A cryoablation system including: A cryoablation balloon catheter, including a cryoablation balloon, used to realize heat transfer between the refrigerant flowing through the cryoablation balloon and the outside world; and The refrigeration device according to any one of claims 1 to 16, wherein the outlet of the cooling tube is disposed inside the cryoablation balloon. A cryoablation temperature control method, characterized in that it is used to cool the refrigerant used for cryoablation, and the method includes: Control the refrigeration unit to cool down the cooling pipe on the coil fixing part through the Stirling cold head, and the coil fixing part is connected to the cooling surface of the Stirling cold head; Obtain the real-time temperature value of the cooling tube, and when the real-time temperature value is lower than the preset phase change threshold, control the heating of the heating component so that the real-time temperature value is within the preset safe ablation range, wherein the heating The assembly is provided on the coil fixture. The cryoablation temperature control method according to claim 18, characterized in that the method further includes: In the initial stage of refrigeration, control the refrigeration unit to rapidly cool down at preset full load power; From any moment within the first preset time before cryoablation to the end of cryoablation, the temperature detection component is controlled to detect the real-time temperature value of the coil fixture, and a proportional integral differential algorithm is used to control the real-time temperature value to be within Within the preset safe ablation range. The cryoablation temperature control method according to claim 18, wherein the side wall of the coil fixing member is provided with an annular pipeline groove, and the pipeline groove is used to accommodate the cooling tube; The coil fixing member is sleeved on the Stirling cold head, so that the cooling pipe in the pipeline groove and the cooling surface can realize heat transfer.