CRYOABLATION APPARATUS AND METHOD

Abstract

A cryoablation device comprises a freezing balloon, a catheter, a storage tank, a delivery pipeline, a recovery pipeline, and a freezing element. Within the freezing balloon circulates a freezing substance, such as a low pressure liquid or gas or a gas-liquid mixture. A cryoablation method comprises the following four steps: pre-freezing, ablation, recovery, and rewarming. Advantages of the cryoablation device and method provided herein: low risk factor, easy to operate, convenient to use, exhibits high freezing efficiency, and temperature control accuracy.

Claims

1-21. (canceled)

22. A cryoablation apparatus comprising: a cryoballoon, provided with a circulating cold carrier medium therein, and adapted for contacting a human tissue and performing cryoablation on the human tissue; a catheter, connected to the cryoballoon, having an inlet end and an outlet end, and adapted for transporting the cold carrier medium into and out of the cryoballoon; a storage tank, provided with the cold carrier medium stored therein; a delivery pipeline, having one end communicated with the storage tank and another end communicated with the inlet end of the catheter; a recovery pipeline, having one end communicated with the storage tank and another end communicated with the outlet end of the catheter; and a refrigeration assembly, connected in series with the delivery pipeline, and adapted for cooling the cold carrier medium in the delivery pipeline.

23. The cryoablation apparatus of claim 22 wherein the refrigeration assembly comprises: a first cold energy exchanger, mounted on the delivery pipeline and used for cooling the cold carrier medium flowing through the first cold energy exchanger by heat exchange; and a cold energy generator, for generating cold energy and providing the cold energy to the first cold energy exchanger.

24. The cryoablation apparatus of claim 23 further comprising a bypass pipe communicated with the delivery pipeline and the recovery pipeline to allow the delivery pipeline and the recovery pipeline to form a precooling looping path connecting the storage tank and the first cold energy exchanger in series, wherein the bypass pipe is communicated with the delivery pipeline via a first three-way valve.

25. The cryoablation apparatus of claim 23 wherein the refrigeration assembly further comprises a second cold energy exchanger having a hot fluid channel mounted on the delivery pipeline and a cold fluid channel mounted on the recovery pipeline, wherein cold energy exchange occurs between the cold fluid channel and the hot fluid channel to precool the cold carrier medium flowing through the hot fluid channel, and wherein the hot fluid channel is connected between the storage tank and the first cold energy exchanger.

26. The cryoablation apparatus of claim 25 wherein the refrigeration assembly further comprises a cold storage device, mounted on the recovery pipeline, communicated with the first cold energy exchanger via the bypass pipe, and adapted for storing cold energy coming from the first cold energy exchanger.

27. The cryoablation apparatus of claim 26 wherein the refrigeration assembly further comprises a heat-insulation device, having a heat-insulation chamber adapted for reducing or eliminating heat conduction to the exterior thereof, wherein the first cold energy exchanger, the second cold energy exchanger, the cold storage device, and a cold energy output end of the cold energy generator are located inside the heat-insulation chamber.

28. The cryoablation apparatus of claim 27 wherein the heat-insulation device is a box mounted with a vacuumizing device communicated with the heat-insulation chamber.

29. The cryoablation apparatus of claim 27 wherein the heat-insulation device is a box with the heat-insulation chamber thereof filled with heat insulation substance.

30. The cryoablation apparatus of claim 23 further comprising a rewarming looping path for transporting the cold carrier medium in the storage tank to the inlet end of the catheter of the cryoablation apparatus.

31. The cryoablation apparatus of claim 30 wherein the rewarming looping path comprises a rewarming pipe, and wherein an inlet end of the rewarming pipe is connected by a second three-way valve to a side of the delivery pipeline that is located upstream of the first cold energy exchanger.

32. The cryoablation apparatus of claim 23 further comprising a rewarming looping path for transporting the cold carrier medium in the storage tank to the inlet end of the catheter of the cryoablation apparatus after heating the cold carrier medium.

33. The cryoablation apparatus of claim 32 wherein the rewarming looping path comprises a rewarming pipe with a heating device connected in series, and wherein an inlet end of the rewarming pipe is connected by a second three-way valve to an upstream side of an inlet to the hot fluid channel.

34. The cryoablation apparatus of claim 30 wherein the rewarming looping path also comprises a rewarming backflow pipeline for connecting the outlet end of the catheter of the cryoablation apparatus to the storage tank.

35. The cryoablation apparatus of claim 34 wherein the rewarming backflow pipeline comprises a rewarming backflow pipe having both ends thereof communicated with the recovery pipeline and being connected in parallel to the second cold energy exchanger, and wherein an inlet of the rewarming backflow pipe is connected by a third three-way valve to the delivery pipeline.

36. The cryoablation apparatus of claim 35 wherein the refrigeration assembly further comprises a heat-insulation device having a heat-insulation chamber adapted for reducing or eliminating heat conduction to the exterior thereof, wherein the first cold energy exchanger, the second cold energy exchanger, a cold storage device, and a cold energy output end of the cold energy generator are located inside the heat-insulation chamber, and wherein the rewarming backflow pipe is located outside the heat-insulation device.

37. A cryoablation method comprising: a precooling step, in which a cold carrier medium is circulated through a cold energy generator for cooling; an ablating step, in which the precooled cold carrier medium is re-circulated through the cold energy generator for re-cooling and then is transported to a target tissue of a human body, so that cold energy exchange occurs between the cold carrier medium and the target tissue to cool the target tissue for cryoablation of the target tissue; a recovering step, in which the cold carrier medium after cold energy exchange with the target tissue is transported out of the human body and into a storage tank; and a rewarming step, in which the transportation of the cooled cold carrier medium into the human body is stopped, and the target tissue is rewarmed.

38. The cryoablation method of claim 37 wherein, in the recovering step, the cold carrier medium after cold energy exchange with the target tissue is transported out of the human body, and residual cold energy in the cold carrier medium transported out of the human body is utilized to carry out cold energy exchange with the cold carrier medium flowing out of the storage tank at a second cold energy exchanger, so as to cause the cold carrier medium before entry into the first cold energy exchanger to be cooled and then transported into the first cold energy exchanger.

39. The cryoablation method of claim 37 wherein a part of cold energy is stored in the precooling stage, and then transferred to the cold carrier medium recovered from a catheter, so as to be exchanged to the cold carrier medium flowing out of the storage tank at a second cold energy exchanger.

40. The cryoablation method of claim 37 wherein, in the rewarming step, the cold carrier medium is circulated through a heating device for being warmed, and then the cold carrier medium after being warmed is transported to the target tissue of the human body, so as to warm the cooled target tissue by heat exchange between the cold carrier medium and the target tissue.

41. The cryoablation method of claim 37 wherein, in the rewarming step, uncooled cold carrier medium is transported to the human body, so as to warm the target tissue by heat exchange between the uncooled cold carrier medium and the target tissue.

Description

DESCRIPTION OF THE DRAWINGS

[0069] In order to explain the specific embodiments of the present invention or the technical solutions in the prior art more clearly, the following will briefly introduce the drawings that need to be used in the specific embodiments or the description of the prior art. Obviously, the appendix in the following description The drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative work.

[0070] FIG. 1 is a schematic diagram of the mechanism of the cryoablation device provided in Embodiment 1 of the present invention;

[0071] FIG. 2 is a schematic diagram of the flow of the cold carrier medium in the pre-cooling stage of the cryoablation device shown in FIG. 1;

[0072] FIG. 3 is a schematic diagram of the flow of the cold medium in the cryoablation device shown in FIG. 1 in the cryoablation stage;

[0073] FIG. 4 is a schematic diagram of the flow of the cold medium in the cryoablation device shown in FIG. 1 during the rewarming stage;

[0074] FIG. 5 is a flowchart of the cryoablation method provided in Embodiment 3 of the present invention;

DESCRIPTION OF REFERENCE SIGNS

[0075] 1—medium storage tank, 2—medium supply pipeline, 3—medium recovery pipeline, 4—cold generating device, 5—first cold-energy exchange device, 6—second cold-energy exchange device, 7—pipe, 8—Freezing balloon, 9—bypass pipe, 10—first three-way valve, 11—cold storage device, 12—heat insulation device, 13—hot insulation chamber, 14—vacuum device, 15—reheating tube, 16—Heating device, 17—second three-way valve, 18—reheating return pipe, 19—third three-way valve, 20—pumping device, 21—flow meter, 22—thermometer, 23—check valve, 24—hot dissipation Device.

DETAILED WAYS

[0076] The technical solutions of the present invention will be clearly and completely described below in conjunction with the accompanying drawings. Obviously, the described embodiments are part of the embodiments of the present invention, rather than all of them. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work shall fall within the protection scope of the present invention.

[0077] In the description of the present invention, it should be noted that the terms “center”, “upper”, “lower”, “left”, “right”, “vertical”, “horizontal”, “inner”, “outer”, etc. The indicated orientation or positional relationship is based on the orientation or positional relationship shown in the drawings, which is only for the convenience of describing the present purposes, and cannot be understood as indicating or implying relative importance.

[0078] In the description of the present invention, it should be noted that the term “installed”, “connected” and “connected” should be understood in a broad sense, unless otherwise clearly specified and limited. For example, they can be fixed or detachable. Connected or integrally connected; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication between two components. For those of ordinary skill in the art, the specific meaning of the above-mentioned terms in the present invention can be understood in specific situations.

[0079] In addition, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they the not conflict with each other.

Example 1

[0080] As shown in FIGS. 1 to 4, it is the first embodiment of the present invention. This embodiment provides a cryoablation device, which includes a cryo-balloon 8, a catheter 7, a medium storage tank 1, a medium supply line 2, and a medium recovery The pipeline 3 and the refrigeration components; the refrigerating balloon 8 circulates with a cold medium, which is suitable for contacting human tissue and performing cryoablation; the catheter 7 is connected to the refrigerating balloon 8 and has a medium input end and a medium output end, It is suitable for inputting and outputting cold-carrying medium into the freezing balloon 8; the cold-carrying medium is stored in the medium stooge tank 1, and the cold-carrying medium is a low-pressure medium; one end of the medium supply pipeline 2 is connected with the medium storage tank 1, and the other end The inlet end of the pipe 7 is connected; one end of the medium recovery pipe 3 is connected with the medium storage tank 1, and the other end is connected with the outlet end of the pipe 7; the refrigeration component is connected in series with the medium supply pipe 2 and is suitable for supplying the medium inside the pipe 2 The cooling medium is used for cooling and heat exchange.

[0081] In the process of cryoablation, the cooling medium flows according to the following path: after flowing out of the medium storage tank 1 along the medium supply pipeline 2, passing through the refrigeration components, the temperature of the cooling medium drops, and then enters the medium in the conduit 7 The input end then flows into the freezing balloon 8 through the balloon to contact the target tissue, and then flows out from the media output end of the catheter 7 to the media recovery pipeline 3, and finally returns to the media storage tank 1 to complete a cycle. In the above process, since the original high-pressure gas is replaced with the cold-carrying medium, the cold-carrying medium is directly refrigerated. Compared with the high-pressure gas, it is less prone to explosion, which can effectively reduce the risk of the cryoablation device during use At the same time, because the low-pressure cooling medium can be recycled, there is no need to supplement high-pressure gas during use, which improves its convenience in use. In addition, the low-pressure cold-carrying medium has a single cooling method, which only relies on refrigeration components for cooling. Therefore, the cooling process is easier to control than the cooling method that relies on high-pressure gas throttling, thus effectively reducing the difficulty of its operation. The chief surgeon does not need a professional technician Accompany you to perform the entire procedure.

[0082] As a specific implementation of the refrigeration assembly, the refrigeration assembly includes a refrigeration generating device 4, a first refrigeration exchange device 5, and a second refrigeration exchange device 6. The cooling capacity generating device 4 is used to provide cooling rapacity; the first cooling capacity exchanging device 5 is installed on the medium supply pipeline 2, and the cooling capacity generating device 4 provides cooling capacity to the first cooling capacity exchanging device 5. The first refrigeration exchange device 5 is used to perform refrigeration and heat exchange on the cooling medium passing through the first refrigeration exchange device 5; the second refrigeration exchange device 6 has heat installed on the medium supply pipe 2 The fluid channel and the cold fluid channel installed on the medium recovery pipeline 3, the cold fluid channel and the hot fluid channel generate cold energy exchange, and the cold medium flowing through the hot fluid channel Cold; the hot fluid channel is connected between the medium storage tank 1 and the first cold exchange device 5.

[0083] When the above-mentioned refrigeration component participates in cryoablation, the medium supply line 2, the medium recovery line 3, the catheter 7 of the cryoablation system, and the cryo-balloon 8 are used to make the cold-carrying medium circulate. The cold energy generated at 4 places is delivered to the medium supply pipeline 2 through the first cold energy exchange device 5, and then delivered to the human body through the catheter 7 for cryoablation of the target tissue, and the carrier for supercooling exchange with the target tissue. The cold medium then flows from the conduit 7 to the medium recovery pipeline 3. At this time, the cold carrier medium still has some cold capacity. Then, when the cold carrier flows through the medium recovery line 3, due to the second cold exchange device 6 With the existence of, the remaining cold in the cold-carrying medium will be transferred to the cold-carrying medium in the medium supply pipeline 2 through the second cold-exchanging device 6, so that the cold-carrying medium there is pre-cooled.

[0084] In the above process, since the second cooling capacity exchange device 6 is upstream of the first cooling capacity exchange device 5 on the medium supply pipe 2, the temperature of the cooling medium in the medium supply pipe is higher than that of the medium recovery. The temperature in the pipeline 3 can thus ensure that the cold energy is conducted from the medium recovery pipeline 3 to the medium supply pipeline 2. Through the above process, the remaining cold capacity of the cooling medium in the medium recovery pipeline 3 can pre-cool the cooling medium, reduce the initial temperature of the cooling medium when it enters the first cooling capacity exchange device 5, and then at the same cooling capacity In the case of exchange volume, this pre-cooled cold carrier medium can reach a lower temperature, so that this cryoablation method that directly cools the low-pressure medium is more likely to reach the temperature required for cryoablation, and at the same time Improve the efficiency of cold utilization.

[0085] Specifically, the cold generation device 4 in this embodiment is specifically a miniature ultra-low temperature refrigerator capable of providing a cold source below −120° C., which can be in the form of pulse tube, Stirling, mixed working fluid throttling, thermoacoustic, etc. It can be one or more units. When multiple units work together, the joint mode can be series or parallel. The cooling medium in this embodiment is a medium with a low freezing point, such as absolute ethanol.

[0086] In order to further reduce the minimum temperature that the cooling medium can reach, it also includes a bypass pipe 9, which communicates with the medium supply pipe 2 and the medium recovery pipe 3, and allows the medium supply pipe 2 and The medium recovery pipeline 3 forms a pre-cooling circuit connecting the medium storage tank 1 and the first cooling capacity exchange device 5 in series; and the bypass pipe 9 and the medium supply pipeline 2 are in communication through the first three-way valve 10.

[0087] By using the by-pass pipe 9, the refrigerant can be pro-cooled before entering the human body for freezing and ablation. In the pre-cooling stage, the refrigerant will flow through the medium supply pipeline 2 and the second after coming out of the medium storage tank 1. A cold capacity exchange device 5, a bypass pipe 9 and a medium recovery pipeline 3, and finally return to the medium storage tank 1. The temperature of the cold carrier medium after pre-cooling is reduced, and has a lower initial temperature when entering the cryoablation stage, and after cooling by the first cold quantity exchange device 5, it is easier to reach the low temperature required for cryo-ablation. Therefore, this action can further increase the possibility that the cryoablation device is carrying the cold medium to reach the temperature required for cryoablation.

[0088] As an improved embodiment of the cryo-ablation device, it also includes a cold storage device 11, which is installed on the medium recovery pipeline 3, and communicates with the first cold energy exchange device 5 by a bypass pipe 9, suitable for storing the first cold energy exchange T, amount of cold flowing out of the device 5. In this embodiment, the cold storage device 11 is specifically a box filled with a cold storage medium with a higher specific heat opacity. The medium recovery pipeline 3 passes through the cold storage device 22, and the side wall of the pipeline and the cold storage medium in the cold storage device 11 are used to generate cold energy exchange.

[0089] In the pre-cooling stage, the cold storage device 11 can store part of the cold energy brought by the cold-carrying medium. After the freezing and ablation stage starts, the cold storage device 11 on pre-cool the cold-carrying medium left from the human body to make the first The temperature difference between the cold fluid passage and the hot fluid passage of the second cold quantity exchange device 6 is increased, which increases the cold quantity exchange rate at the second cold quantity exchange device 6, thereby further increasing the temperature of the cold medium in the medium supply pipeline 2 Lowering, these pre-cooled cooling medium on reach a lower temperature after the first cooling capacity exchange device 5 undergoes float cooling. Therefore, this action can further ensure that the cryoablation device can reach the low temperature required for cryoablation, and can further improve the cold energy utilization efficiency and reduce cold energy waste.

[0090] In order to reduce the loss of cold energy, it also includes a heat insulation device 12, the heat insulation device 12 has a heat insulation cavity 13 suitable for redoing or exchange process, and at the same time, the heat preservation effect of the cold storage device 11 is better, and the cold storage device 11 can avoid cold energy loss during the cold storage process.

[0091] Specifically, the heat insulation device 12 is a box, and a vacuum device 14 communicating with the heat insulation cavity 13 is installed on the heat insulation device 12. The heat-insulating cavity 13 close to the vacuum state can further reduce the loss rate of cold energy, so that the cryoablation device further improves the utilization efficiency of cold energy. The vacuum pump 14 is specifically a small vacuum pump.

[0092] As another alternative implementation of the heat insulation device, the heat insulation device 12 is a box, and the heat insulation cavity 13 is filled with a heat insulation material, where the heat insulation material may be a polyurethane foam material or aerogel material.

[0093] In order to meet the needs of the target tissue during cryoablation for rewarming after freezing, this embodiment also includes a rewarming circuit for heating the cold carrier medium in the storage tank and then transporting it to freezing The media input end of the catheter 7 in the ablation device. In cryoablation, the frozen target tissue needs to be rewarmed. The ideal rewarming process can improve the surgical effect of cryoablation and reduce the probability of postoperative complications. The rewarming circuit provided in the present invention can heat the cold-carrying medium and transport it to the target tissue through the catheter 7. This separately arranged rewarming circuit can not only meet the needs of cryoablation for rewarming, but also is very useful It is conducive to more precise control of the temperature, process and time of rewarming, thereby increasing the surgical cure rate and reducing postoperative complications.

[0094] Specifically, the reheating circuit includes a reheating pipe 15 which is connected in series with a heating device 16; the medium inlet end of the reheating pipe 15 uses a second three-way valve 17 and enters the hot fluid The inlet of the channel is connected upstream. After the reheating pipe 15 is connected to the upstream of the second refrigeration exchange device 6 on the medium supply pipeline 2, the reheating pipe 15 is connected in parallel with the first refrigeration exchange device 5 and the second refrigeration exchange device 6. The pipeline used for heating the refrigerant and the pipeline used for cooling are independent of each other. Therefore, it is possible to avoid the residual cooling capacity of the first refrigeration exchange device 5 and the second refrigeration exchange device 6 from interfering with the heating process of the easier refrigerant during the rewarming stage, reduce the interference factors of the rewarming process, and control the rewarming process It is easier to control.

[0095] As an alternative implementation of the above reheating circuit, the reheating circuit includes: a reheating pipe 15; the medium inlet end of the reheating pipe 15 is installed on the medium supply pipeline 2 by using a second three-way valve 17 The side that does not enter the first cold quantity exchange device 5 is connected. In this alternative embodiment, there is no series heating device on the rewarming circuit, but only the uncooled cold easier medium is introduced into the catheter to participate in the rewarming process, and the body's own heat is used for rewarming. This makes the temperature rise of the targeted tissues more gentle and reduces the damage to healthy tissues caused by cryoablation.

[0096] As a further improvement of the reheating circuit, the reheating circuit also includes a reheating return line, which is used to connect the medium output end of the catheter 7 in the cryoablation device with the recovery port of the medium storage tank 1 Connected. The separate reheating return line can make the reheating process form a separate reheating circuit composed of the medium storage tank 1, the reheating tube 15, the cryoablation device, and the reheating return line, thereby further reducing the temperature during the reheating process. Interference factors make the process of rewarming more precise.

[0097] Specifically, the reheating return pipe includes a reheating return pipe 18, both ends of which are connected with the medium recovery pipe 3 and connected in parallel with the second cold quantity exchange device 6; the medium inlet end of the reheating return pipe 18 is used The third three-way valve 19 is connected to the medium supply pipeline 2. Further, the reheating return pipe 18 is located outside the heat insulation device 12. After the reheating return pipe 18 is arranged outside the heat insulation device 12, it can prevent the reheating return pipe 18 from taking away the cold storage device 11 or the second cold energy exchange device 6 when the reheating refrigeration medium is transported. Increase the utilization rate of cooling capacity.

[0098] In order to ensure the smooth circulation of the cooling medium, a pumping device 20 is connected in series to the medium supply pipeline 2 or the medium recovery pipeline 3, and the pumping device 20 is adapted to provide power for the flow of the cooling medium.

[0099] The cryoablation device provided in this embodiment also includes an operating device. The operating device includes a handle and an actuator for operating the catheter 7 to reach the target tissue for ablation. When performing cryoablation, the catheter 7 is a pipe that transports low-temperature cold-carrying medium, and is made of a material with a certain degree of toughness, a small thermal conductivity, and physiological compatibility. It has multiple flow channels inside, which are respectively The inlet and outlet flow channels, functional channels and isolation chambers of cold media. The cooling medium inlet and outlet flow channels are distributed on both sides to insulate the inlet and outlet fluids and avoid thermal short circuits. The functional channel is located in the center of the catheter 7 and is used for routing of functional components such as sensors and guidewires. The isolation cavities are distributed at both ends of the cold medium flow channel to further reduce the heat exchange of the fluid in and out. The tube 7 is wrapped with thermal insulation material to reduce the heat transfer between the cold-carrying medium in the duct 7 and external human tissues, on the one hand, to reduce the heat leakage of the cold-carrying medium, and on the other hand, to avoid freezing of the tissue caused by the low temperature of the outer wall of the duct 7 The cryo-balloon 8 is used for cryoablation of the target tissue, and has a medium inlet and a medium outlet inside. The medium inlets connected with the inlet of the catheter 7 and the outlet of the medium is connected with the outlet of the catheter 7. After the balloon contacts the tissue, the cold-carrying medium exchanges heat with the tissue through the balloon wall.

Example 2

[0100] As shown in FIG. 5, it is the second embodiment of the present invention. This embodiment provides a cryoablation method. In this method, a cold-carrying medium using a low-pressure medium is directly passed into the human body after refrigeration to perform targeted tissues on the human body. Cryoablation includes the following steps:

[0101] For pre-cooling, a low-pressure cooling medium is passed into the cooling capacity generating device 4 for cooling.

[0102] In ablation, the pre-cooled cold-carrying medium is circulated into the cold generation device 4, and then passed into the target tissue of the human body, so that the cold-carrying medium and the target tissue can exchange cold, so that the target tissue is cooled Then the target tissue is cryoablated.

[0103] Recycling, transport the cold-carrying medium after cold exchange with the target taste from the human body and transport it to the storage tank.

[0104] After rewarming, stop passing the cooled cold carrier medium into the human body to raise the temperature of the target tissue.

[0105] In the above steps, due to the pre-cooling slip, the cooling medium has a lower temperature after being pre-cooled, so that the initial temperature during the cooling process in the ablation stage will be lower, so the temperature that can be finally reached will be lower. Compared with the prior art method of directly cooling the cold-carrying medium and then passing it into the human body, the cold-carrying medium in this method can more easily reach the low temperature required for cryoablation.

[0106] In the recovery step, the cold-carrying medium after the cold exchange with the target tissue is transported from the human body, and the remaining cold in the cold-carrying medium and the cold-carrying medium that has not been passed into the cold generating device 4 are used for cooling. The quantity exchange, the cooling medium that has not yet passed into the cooling capacity generating device 4 is cooled and then transported to the cooling capacity generating device 4. In the recovery step, the remaining cold energy of the cooling medium in the medium recovery pipeline 3 can be reused, the utilization efficiency of the cold energy can be improved, and the power burden of the cold energy generating device 4 can be reduced.

[0107] In the pre-cooling step, a part of the cold energy is stored, and the cold energy is transported to the cold-carrying medium sent from the human body to cool the cold-carrying medium sent from the human body. Through the above steps, these pre-stored refrigeration can be transferred to the medium recovery pipeline 3 to reduce the temperature of the refrigerating medium, so that the residual refrigeration of the conveyed refrigerating medium can be used in the recovery step to perform The temperature difference in the

[0108] As a specific embodiment of the rewarming step, in the rewarming step, the cooling medium is circulated through the heating device (16), the cooling medium is heated, and then the heated cooling medium is passed into the target of the human body At the tissue, the cold-carrying medium and the target tissue generate heat exchange, so that the temperature of the target tissue after cooling is raised.

[0109] As an alternative implementation of the above-mentioned rewarming step, in the rewarming step, a cold-carrying medium that has not been refrigerated can also be input into the human body, so that the target tissue can exchange heat with the cold-carrying medium that has not beet refrigerated and then increase in temperature.

[0110] In combination with the cryoablation device in Embodiment 1, the specific process of the cryoablation method in this embodiment is:

[0111] In the pre-cooling stage, see FIG. 2. The cooling capacity generating device 4 and the pumping device 20 are opened, and the three three-way valves are adjusted to make the cooling medium flow according to the following process: After the normal temperature cooling medium flows out of the medium storage tank 1, After passing through the flow meter, the pumping device 20, and the flow regulating valve, it enters the heat insulation device 12. After passing through the second refrigeration exchange device 6 to exchange heat with the refluxing refrigerating medium for pre-cooling, it enters the first refrigeration exchange device 5 for cooling, After passing through the bypass pipe 9, it enters the cold storage device 11, stores a part of the cold energy in the cold storage device 11, and then flows back to the second cold energy exchange device 6 to pre-cool the cold carrier medium left from the medium storage tank 1, and finally It flows out of the heat insulation device 12 and finally returns to the medium storage tank 1.

[0112] After about 20 minutes of pre-cooling cycle, the cooling medium drops to minus 80-100° C.

[0113] In the ablation stage, refer to FIG. 3. After the pre-cooling is completed, adjust the three three-way valves so that the cooling medium flows according to the following process: after passing through the flow meter, the pumping device 20, and the flow regulating valve, it enters the insulation device 12, and passes through the first After the second cooling capacity exchange device 6 exchanges heat with the refluxed cooling medium, it enters the first cooling capacity exchange device 5 for cooling. After the cooling medium is cooled by the first cooling capacity exchange device 5, it flows out of the heat insulation device 12 and enters the duct 7. Then enter the freezing balloon 8 for ablation, then flow out of the catheter 7, return to the heat insulation device 12, and flow through the cold storage device 11. At this time, the temperature of the cold carrier medium is higher than the temperature of the heat storage medium in the cold storage device 11. The heat storage medium releases heat and the temperature drops, and then enters the second cooling capacity exchange device 6 to exchange cooling capacity for the cooling medium flowing out of the medium storage tank 1, then exits the heat insulation device 12 and returns to the medium storage tank 1.

[0114] In the rewarming stage, refer to FIG. 4. After the freezing and ablation is completed, adjust the three three-way valves to make the cooling medium flow according to the following process: the cooling medium first comes out of the medium storage tank 1 and flows through the flow meter and the pumping device 20 After the flow control valve, it enters the heating device 16 and is heated to 37° C. by the heating device 16, and then enters the catheter 7 through the rewarming tube 15, heating and rewarming the ablated tissue, and flows out of the catheter 7 and passes through the third three-way The valve 10 flows through the reheating return pipe 18 and then returns to the medium storage tank 1.

[0115] Obviously, the above-mentioned embodiments are merely examples for clear description, and are not intended to limit the implementation. For those of ordinary skill in the art, other changes or changes in different forms can be made on the basis of the above description. It is unnecessary and impossible to list all the implementation methods here. The obvious changes or modifications derived from this are still within the protection scope created by the present invention.