Cryoablation system, cryoablation catheter and control method of cryoablation catheter

Abstract

The invention relates to a cryoablation system, a cryoablation catheter and a control method of the cryoablation catheter. The cryoablation catheter comprises a slender body, an expandable assembly and a temperature measuring assembly, the expandable assembly is arranged at the far end of the slender body, and the expandable assembly can block a vein mouth when in an expanded structure; the slender body comprises an outer tube and a main body tube, the outer tube and the main body tube define an airflow channel, the main body tube is provided with a first conveying channel, the airflow channel is communicated with the expandable assembly, and the first conveying channel penetrates through the main body tube and is used for conveying mild liquid to veins; the temperature measuring assembly is arranged on the expandable assembly and can detect the temperature of the vein mouth so as to judge the effectiveness of plugging of the expandable assembly. Thus, the temperature measuring assembly on the expandable assembly is used for measuring temperature changes to judge the blocking state, the usage amount of contrast agents and X-rays can be reduced, the specific leakage position can be judged, ablation treatment can be conveniently carried out in the later period, and the treatment effect is guaranteed.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and particularly to a cryoablation system, a cryoablation catheter and a control method thereof. Background Art

[0002] Patients with atrial fibrillation have a high risk of stroke. When atrial fibrillation occurs, the atrium beats irregularly and rapidly, losing its systolic function. Blood is prone to stagnate in the atrium and form thrombus. When the thrombus detaches and enters the brain through the artery, stroke occurs. Through an interventional catheter, energy is applied to the pulmonary vein for ablation to isolate the pulmonary vein potential and achieve the treatment effect. Cryoballoon ablation is based on anatomical considerations and uses the contact between the balloon and the tissue for freezing, with characteristics such as being disposable and continuous. The cryoballoon achieves cryoablation mainly through the throttling expansion effect, which refers to the temperature drop caused by the expansion and heat absorption of a high-pressure fluid when it passes through a fine capillary to reach a low-pressure area.

[0003] The cryoablation instrument is the control integration of the entire system, mainly composed of a control panel, a cooler storage container, a vacuum system, and related pipelines. The refrigerant under high pressure is stored in a steel cylinder that is isolated from the outside at normal temperature. When cryoablation starts, the refrigerant is pressurized and cooled by the built-in device of the cryoablation instrument and then reaches the inside of the balloon through a capillary. The liquefied refrigerant sprays out through the small holes on the surface of the capillary and then rapidly vaporizes and expands, quickly taking away the temperature inside the balloon, causing the balloon to cool significantly and generating a cryoablation effect.

[0004] The effectiveness of cryoballoon ablation is based on the effective occlusion of the pulmonary vein by the balloon, so that the blood in the pulmonary vein is completely blocked, so that the energy of the balloon can be effectively transmitted to the tissue during ablation. Currently, during cryoablation surgery, a contrast agent is transmitted from the internal channel of the catheter to the balloon end, and it is judged whether there is leakage under X-ray, so as to judge whether the balloon effectively occludes this time. However, this method requires doctors and patients to be exposed to X-rays in large amounts, which will bring health risks. In addition, some patients are intolerant to the contrast agent (such as being allergic to the contrast agent or having renal insufficiency), and the imaging system can only present two-dimensional images. When there is leakage behind the image, doctors need to continuously adjust the orientation to judge the specific leakage position, or the leakage position is blocked, and at this time, misjudgment is likely to occur, thus affecting the treatment effect. Summary of the Invention

[0005] Based on this, in view of the safety problem of using a contrast agent to judge leakage and the problem of difficult determination of the leakage position, it is necessary to provide a cryoablation system, a cryoablation catheter and a control method thereof, which judge whether there is effective occlusion by delivering a mild liquid to the vein and cooperating with temperature measurement, reduce the usage amount of the contrast agent and X-rays, and can facilitate the judgment of the specific leakage position when leakage occurs for effective occlusion to ensure the treatment effect.

[0006] A cryoablation catheter includes a slender body, an expandable component, and a temperature measuring component. The expandable component is disposed at the distal end of the slender body and has an expanded configuration and a contracted configuration. When the expandable component is in the expanded configuration, it can block the venous orifice.

[0007] The slender body includes an outer tube and a main body tube. The outer tube is sleeved on the main body tube and is connected to the expandable component at the distal end. The outer tube and the main body tube enclose an air flow channel, and the air flow channel communicates with the expandable component. The main body tube has a first delivery channel extending axially therethrough for delivering mild liquid to the vein.

[0008] The temperature measuring component is disposed on the expandable component and can detect the temperature of the venous orifice to determine the effectiveness of the blockage by the expandable component.

[0009] In an embodiment of the present application, the expandable component includes a first expandable element and a second expandable element. The first expandable element wraps the second expandable element. The inner cavity of the second expandable element communicates with the air flow channel. The temperature measuring component is disposed between the first expandable element and the second expandable element and on the outer wall of the second expandable element.

[0010] In an embodiment of the present application, the number of the temperature measuring components is multiple, and the multiple temperature measuring components are disposed on the expandable component;

[0011] There is a spacing between adjacent temperature measuring components, or the multiple temperature measuring components cover the expandable component.

[0012] In an embodiment of the present application, the temperature measuring component includes a temperature measuring element and a fixing component. The fixing component fixes the temperature measuring element on the expandable component, and the temperature measuring element and the fixing component are stretched as the expandable component expands.

[0013] In an embodiment of the present application, the temperature measuring element includes a linear element and a temperature measuring point. The linear element is disposed on the fixing component, and the temperature measuring point is disposed at the distal end or the middle region of the linear element.

[0014] In an embodiment of the present application, the cryoablation catheter further includes a marking point disposed on the fixing component for marking the relative position between the temperature measuring element and the venous orifice.

[0015] In an embodiment of the present application, each fixing component has at least one marking point, and the marking points on each fixing component are different from each other.

[0016] In an embodiment of the present application, at least a part of the fixed components has at least one of the marked points, and among the fixed components having the marked points, the marked points on each of the fixed components are different from each other.

[0017] In an embodiment of the present application, the fixed components having the marked points are arranged adjacent to each other, and at least one fixed component having the marked point is provided between adjacent fixed components without the marked point, and at least one fixed component without the marked point is provided between adjacent fixed components having the marked point.

[0018] In an embodiment of the present application, at least one of the number, shape, and / or length of the marked points on each of the fixed components having the marked points is different.

[0019] A control method for a cryoablation catheter is applied to the cryoablation catheter according to any one of the above technical features, and the control method includes the following steps:

[0020] Insert the distal end of the cryoablation catheter into the venous orifice.

[0021] Deliver gas to the expandable component to expand the expandable component to block the venous orifice.

[0022] Inject a mild liquid into the vein and mix it with the blood in the vein.

[0023] The temperature measurement component acquires the temperature of the venous orifice and feeds it back to the controller of the cryoablation device, and the controller determines whether the expandable component effectively blocks the venous orifice according to the temperature rise rate of the venous orifice.

[0024] In an embodiment of the present application, the controller determines whether the expandable component effectively blocks the venous orifice according to the temperature change of the venous orifice, including the following steps:

[0025] After injecting the mild liquid into the vein, the temperature measurement component acquires the first temperature after the mild liquid and the blood are mixed at the venous orifice.

[0026] After a preset time, the temperature measurement component acquires the second temperature of the venous orifice and feeds it back to the controller. The second temperature is greater than the first temperature, and the controller determines whether the expandable component effectively blocks the venous orifice according to the temperature rise rate from the first temperature to the second temperature.

[0027] In an embodiment of the present application, when the controller determines whether the expandable component effectively blocks the venous orifice according to the temperature rise rate of the second temperature, it further includes the following steps:

[0028] When the controller determines that the second temperature is at the first rising rate, the controller determines that the expandable component effectively blocks the venous orifice;

[0029] When the controller determines that the second temperature is at the second rising rate, the controller determines that the expandable component does not effectively block the venous orifice;

[0030] Wherein, the first rising rate is less than the second rising rate.

[0031] In an embodiment of the present application, there are multiple temperature measuring components, which are arranged on the expandable component and are circumferentially distributed to contact the inner wall of the venous orifice. The control method further includes the following steps:

[0032] After injecting the mild liquid, each of the temperature measuring components respectively obtains the temperature at the corresponding position of the venous orifice;

[0033] If the temperatures obtained by each of the temperature measuring components rise steadily, the expandable component effectively blocks the venous orifice;

[0034] If the temperature obtained by at least one of the temperature measuring components rises rapidly, there is a leak at the expandable component corresponding to the temperature measuring component;

[0035] Rotate the cryoablation catheter until the temperatures obtained by each of the temperature measuring components rise steadily.

[0036] A cryoablation system includes a cryogenic device, a display control device, and a cryoablation catheter as described in any of the above technical features. The display control device is connected to the cryogenic device. The proximal end of the control handle of the cryoablation catheter is connected to the cryogenic device, and the distal end extends into the venous orifice for blocking the venous orifice.

[0037] After adopting the above technical solution, the present application has at least the following technical effects:

[0038] For the cryoablation system, cryoablation catheter and its control method of the present application, after the distal end of the cryoablation catheter is delivered to the venous orifice, gas is delivered through the gas flow channel to make the expandable component in an expanded configuration and block the venous orifice. At this time, the temperature measuring component can obtain the temperature of the blood at the venous orifice and feedback it to the controller of the cryogenic device. Subsequently, mild liquid is delivered to the vein through the first delivery channel. After the mild liquid is mixed with the blood, the temperature measuring component detects the temperature of the venous orifice to determine whether the expandable component effectively blocks the venous orifice when it is in the expanded configuration.

[0039] This cryoablation catheter delivers gas to the gas flow channel of the main body tube to achieve the expansion of the expandable component, so that the expandable component is in an expanded configuration and blocks the venous orifice. Moreover, before ablation, the cryoablation catheter delivers harmless mild liquid to the vein through the first delivery channel. The temperature measurement component on the expandable component can be used to measure the temperature change to judge the occlusion state this time, so as to judge whether there is leakage between the expandable component and the venous orifice, and it can also reduce the usage amount of contrast agent and X-ray, avoiding harm to the health of doctors and patients. At the same time, the specific position of the leakage can be judged through the temperature measurement component, which can then help the operator quickly rotate and / or move to adjust the direction and position of the expandable component for effective occlusion, facilitating subsequent ablation treatment and ensuring the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1 FIG. is a schematic diagram of the cryoablation catheter according to an embodiment of the present application applied to a cryoablation system.

[0041] Figure 2 is Figure 1 a schematic diagram of the cryoablation catheter shown.

[0042] Figure 3 is Figure 2 a schematic diagram of the distal end of the cryoablation catheter shown effectively occluding the venous orifice.

[0043] Figure 4 is Figure 2 a schematic diagram of the distal end of the cryoablation catheter shown not effectively occluding the venous orifice.

[0044] Figure 5 is Figure 2 a schematic diagram of the expandable component of the cryoablation catheter in an expanded configuration.

[0045] Figure 6 is Figure 5 a top view of one embodiment of the distal end of the cryoablation catheter shown.

[0046] Figure 7 is Figure 5 a top view of another embodiment of the distal end of the cryoablation catheter shown.

[0047] Figure 8 is Figure 2 a temperature change curve of the temperature rise of the temperature measurement component after the cryoablation catheter is effectively occluded.

[0048] Figure 9 is Figure 2 a temperature change curve of the temperature rise of the temperature measurement component after the cryoablation catheter is not effectively occluded.

[0049] Wherein: 10, cryoablation catheter; 100, slender body; 110, outer tube; 120, main body tube; 121, helix opening; 130, air flow channel; 140, flexible tube; 150, temperature sensor; 160, imaging element; 200, expandable assembly; 210, first expandable element; 220, second expandable element; 300, temperature measurement assembly; 310, fixing component; 320, temperature measurement element; 321, temperature measurement point; 322, linear element; 330, marker point; MT1, first temperature measurement component; MT2, second temperature measurement component; MT3, third temperature measurement component; MT4, fourth temperature measurement component; MT5, fifth temperature measurement component; MT6, sixth temperature measurement component; 400, control handle; 410, electrical interface; 420, first interface; 430, second interface; 50, vein; 510, vein orifice; 60, cryo device; 70, display control device. Detailed implementation manners

[0050] To make the above objects, features, and advantages of the present application more apparent and understandable, the following will describe the detailed implementation manners of the present application in conjunction with the accompanying drawings. Many specific details are set forth in the following description to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without departing from the connotation of the present application. Therefore, the present application is not limited by the specific embodiments disclosed below.

[0051] In the description of the present application, it should be understood that if such terms as "center", "longitudinal", "transverse", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or positional relationship indicated by these terms is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present application and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of the present application.

[0052] In addition, if such terms as "first" and "second" appear, these terms are only for descriptive purposes and should not be construed as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, features defined with "first" and "second" may explicitly or implicitly include at least one such feature. In the description of the present application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise specifically defined.

[0053] In this application, unless otherwise clearly specified and defined, if terms such as "installed", "connected", "joined", "fixed", etc. appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or integrated; 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 communication inside two components or the interaction relationship between two components, unless otherwise clearly defined. For those of ordinary skill in the art, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0054] In this application, unless otherwise clearly specified and defined, if there is a description such as a first feature being "on" or "under" a second feature, its meaning can be that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "over", and "on top of" the second feature can mean that the first feature is directly above or obliquely above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. The first feature being "under", "beneath", and "underneath" the second feature can mean that the first feature is directly below or obliquely below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0055] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it can be directly on the other element or there can also be an intermediate element. If an element is considered to be "connected" to another element, it can be directly connected to the other element or there may be an intermediate element at the same time. If so, the terms "vertical", "horizontal", "up", "down", "left", "right", and similar expressions used in this application are only for the purpose of illustration and do not represent the only implementation.

[0056] See Figures 1 to 4 , this application provides a cryoablation catheter 10. Figure 1 FIG. is a schematic diagram of the cryoablation catheter 10 of an embodiment of this application applied to a cryoablation system. Figure 2 is Figure 1 a schematic diagram of the cryoablation catheter 10 shown in Figure 3 is Figure 2 a schematic diagram of the distal end of the cryoablation catheter 10 shown in effectively blocking the venous orifice 510. Figure 4 is Figure 2Schematic diagram of the distal end of the cryoablation catheter 10 not effectively blocking the venous orifice 510. The cryoablation catheter 10 is applied in a cryoablation system and is connected to the cryoablation system. The distal end of the cryoablation catheter 10 can extend into a blood vessel and move in the blood vessel until it reaches the venous orifice 510. The cryoablation catheter 10 can block the venous orifice 510 and perform cryoablation on the lesion site near the venous orifice 510 to achieve the purpose of treatment. In this application, the venous orifice 510 is the end where the vein 50 discharges blood, and the vein 50 here refers to the pulmonary vein. Of course, in other embodiments of this application, the cryoablation catheter 10 can also block other veins or other blood vessels to perform ablation treatment on the nearby lesion sites. Only the example of the cryoablation catheter 10 blocking the venous orifice 510 is described hereinafter for illustration.

[0057] It can be understood that currently, in cryoablation surgery, a contrast agent is transmitted from the internal channel of the catheter to the balloon end, and it is judged whether there is leakage of the contrast agent under X-ray, so as to judge whether the balloon effectively blocks. However, this method requires doctors and patients to be exposed to X-rays in large amounts, which will bring health risks. In addition, some patients are intolerant to the contrast agent. Moreover, the leakage position is prone to misjudgment, thus affecting the treatment effect. For this reason, this application provides a novel cryoablation catheter 10, which judges whether it effectively blocks by delivering a mild liquid to the vein 50 and cooperating with temperature measurement, avoiding the occurrence of leakage, facilitating subsequent ablation treatment, reducing the usage amount of the contrast agent and X-rays, avoiding harm to the health of doctors and patients, and being able to facilitate the judgment of the specific leakage position when leakage occurs for effective blocking to ensure the treatment effect. The following introduces the specific structure of the cryoablation catheter 10 in an embodiment.

[0058] See Figures 1 to 5 , in an embodiment, the cryoablation catheter 10 includes a slender body 100, an expandable component 200, and a temperature measurement component 300. The expandable component 200 is arranged at the distal end of the slender body 100 and has an expanded configuration and a contracted configuration. When the expandable component 200 is in the expanded configuration, it can block the venous orifice 510. The slender body 100 includes an outer tube 110 and a main body tube 120. The outer tube 110 is sleeved on the main body tube 120 and is connected to the expandable component at the distal end. The outer tube 110 and the main body tube 120 enclose an air flow channel 130. The main body tube 120 has a first delivery channel extending along the axial direction. The air flow channel 130 communicates with the expandable component 200, and the first delivery channel penetrates through the main body tube 120 for delivering a mild liquid to the vein 50. The temperature measurement component 300 is arranged on the expandable component 200 and can detect the temperature of the venous orifice 510 to judge the effectiveness of the block by the expandable component 200. Figure 5 For Figure 2 Schematic diagram of the expandable component 200 of the cryoablation catheter 10 in the expanded configuration.

[0059] The elongated body 100 extends along its length direction and has a proximal end and a distal end which are oppositely arranged. The proximal end refers to the end of the elongated body 100 close to the operator, and the distal end refers to the end of the elongated body 100 away from the operator and close to the patient. The axial direction and the length direction refer to the direction of the connection line between the proximal end and the distal end. It should be noted that the proximal end and the distal end of the elongated body 100 are also applicable to other components, which will not be elaborated later. The distal end of the elongated body 100 is provided with an expandable component 200. The distal end of the elongated body 100 can extend into the blood vessel and drive the expandable component 200 to move in the blood vessel so as to push the expandable component 200 to the venous orifice 510.

[0060] As Figure 2 shown, the outer tube 110 is sleeved on the main body tube 120 to form the main body structure of the elongated body 100. There is a gap between the inner wall of the outer tube 110 and the outer wall of the main body tube 120, and an air flow channel 130 is enclosed. The air flow channel can supply gas and gaseous refrigerant to flow. The distal ends of the outer tube 110 and the main body tube 120 are connected to the expandable component to form an annular air flow channel 130 with a proximal opening and a distal closing. The inner cavity of the expandable component 200 is communicated with the air flow channel 130, and the expandable component 200 has an expanded configuration and a contracted configuration. When the expandable component 200 is in the contracted configuration, it is convenient for the elongated body 100 to drive the expandable component 200 to be pushed in the blood vessel. When the elongated body 100 pushes the expandable component 200 to the venous orifice 510, when gas is introduced into the expandable 200 through the air flow channel, the expandable component 200 switches from the contracted configuration to the expanded configuration. At this time, the expandable component 200 can block the venous orifice 510 to prevent blood from flowing out of the vein 50 through the venous orifice 510, so as to facilitate the subsequent cryoablation operation.

[0061] The main body tube 120 is hollow inside. The main body tube 120 has a hollow and independent first delivery channel and a second delivery channel, and the first delivery channel and the second delivery channel extend axially. The first delivery channel penetrates through the main body tube 120, that is, the proximal end of the first delivery channel penetrates to the proximal end of the main body tube 120, and the distal end penetrates to the distal end of the main body tube 120. Both sides of the first delivery channel are openings. When the expandable assembly 200 blocks the venous orifice 510, the distal end of the main body tube 120 is located in the vein 50. Subsequently, the mild liquid enters from the proximal end of the first delivery channel and flows in the first delivery channel, and is sent into the vein 50 through the distal end of the first delivery channel. The mild liquid mixes with the blood in the vein 50 to determine whether the expandable assembly 200 effectively blocks the venous orifice 510. When the expandable assembly 200 effectively blocks the venous orifice 510, the expandable assembly 200 can seal and contact the venous orifice 510 to prevent blood from leaking from the venous orifice 510. When the expandable assembly 200 does not effectively block the venous orifice 510, there is a gap between the expandable assembly 200 and the venous orifice 510 at at least one position, and the blood in the vein 50 will leak from the gap, affecting the subsequent ablation treatment. At this time, it is necessary to operate the cryoablation catheter 10 to move and / or rotate the cryoablation catheter 10 to adjust the direction and position of the expandable assembly 200 to ensure that the expandable assembly 200 effectively blocks the venous orifice 510, facilitating the subsequent ablation treatment operation.

[0062] There is a certain distance between the second delivery channel and the distal end of the main body tube 120. The second delivery channel communicates with the expandable assembly 200, and the second delivery channel communicates with the gas flow channel 130. When inflating, the gas flow channel is used to transport gas, and the gas flow channel can transport the gas to the expandable assembly 200. At this time, the expandable assembly 200 can block the venous orifice 510. The second delivery channel is used to transport the refrigerant, and the gas flow channel can also output the gaseous refrigerant after cryoablation. When the expandable assembly 200 completely blocks the venous orifice 510, the second delivery channel can transport the refrigerant to the expandable assembly 200 to perform the cryoablation operation. Specifically, the refrigerant enters from the proximal end of the second delivery channel, and then the refrigerant is transported into the inner cavity of the expandable assembly 200 to perform the cryoablation operation at the venous orifice 510. After cryoablation, the refrigerant will become gaseous and flow out from the gas flow channel.

[0063] See Figures 3 to 5, To achieve the detection of the effectiveness of the occlusion, the present application provides a temperature measuring component 300 on the expandable component 200, and the temperature measuring component 300 is electrically connected to the controller of the freezing device 60. After the expandable component 200 occludes the venous orifice 510, the temperature measuring component 300 is located at the venous orifice 510. The temperature measuring component 300 can detect the temperature of the blood in the venous orifice 510 and feedback it to the controller, and the controller determines the effectiveness of the occlusion of the venous orifice 510 by the expandable component 200 based on this temperature. When the expandable component 200 effectively occludes the venous orifice 510, ablation treatment can be performed on the lesion site around the venous orifice 510. When the expandable component 200 does not effectively occlude the venous orifice 510, blood will flow out from the vein 50 through the venous orifice 510. At this time, the direction and position of the expandable component 200 need to be adjusted so that the expandable component 200 occludes the venous orifice 510.

[0064] It can be understood that the logic for judging whether the occlusion is effective is as follows: starting from the temperature measured by each temperature measuring component 300 on the surface of the expandable component 200 dropping to the lowest temperature, calculate the rate or amplitude of the temperature rise within a certain period of time to judge the occlusion state of the expandable component 200 on the vein 50. When the temperature rises steadily, the rising rate is slow, and the amplitude is small, the expandable component 200 effectively occludes the venous orifice 510. When the temperature rises rapidly, the rising efficiency is high, and the amplitude is large, the expandable component 200 does not effectively occlude the venous orifice 510. In the following text, only the rising rate is taken as an example for illustration. When the rising rate is fast, the temperature rises rapidly, and when the rising rate is slow, the temperature rises steadily.

[0065] When the expandable component 200 completely occludes the venous orifice 510, the blood in the vein 50 cannot flow into the atrium. After injecting a certain amount of mild liquid into the main tube 120 through the first delivery channel, the mild liquid flows into the blood in the vein 50 through the distal end of the first delivery channel. At this time, the mild liquid cannot flow into the atrium. As the mild liquid and the blood are gradually mixed, the temperature in the vein 50 gradually decreases from the initial temperature of the blood. The decreasing temperature of the blood is measured by the temperature measuring component 300. After the temperature measuring component 300 measures that the blood drops to the lowest temperature, the temperature of the blood will be maintained for a period of time or slowly rise under the influence of body temperature, and the rising amplitude is small within a certain period of time. That is, after the expandable component 200 completely occludes the venous orifice 510, the temperature measuring component 300 starts to rise steadily after detecting the lowest temperature, indicating that the expandable component 200 effectively occludes the venous orifice 510, as Figure 3 and Figure 5 shown.

[0066] When the expandable component 200 does not completely block the venous orifice 510, there is a certain gap between the venous orifice 510 and the expandable component 200, and the blood in the vein 50 flows from the gap into the atrium. After the expandable component 200 is inflated to the expandable configuration, a certain amount of mild liquid is injected into the main body tube 120 through the first delivery channel. The mild liquid flows into the blood of the vein 50 through the distal end of the first delivery channel. After the mild liquid is gradually mixed with the blood, part of it will flow into the atrium through the gap between the expandable component 200 and the venous orifice 510. Under the scouring of the blood flow, after the temperature of the venous orifice 510 drops to the lowest point, it will rise at a relatively fast rate and the rising amplitude is relatively large within a certain period of time. That is, after the expandable component 200 does not completely block the venous orifice 510, the temperature measuring component 300 at the gap starts to rise rapidly after detecting that the temperature drops to the lowest temperature, indicating that the expandable component 200 does not effectively block the venous orifice 510. At this time, the position of the gap can be judged according to the difference in the temperature rising rate of the temperature measuring component 300, and then the operator can adjust the direction and position of the expandable component 200 to ensure complete blocking of the venous orifice 510.

[0067] The cryoablation catheter 10 uses mild liquid instead of contrast agent, and judges the blocking condition of the expandable component 200 on the venous orifice 510 by detecting the temperature change on the surface of the expandable component 200 through the temperature measuring component 300. The final blocking state is displayed on the display screen of the display control device 70 by the controller in an intuitive manner. When the controller judges that the temperature detected by the temperature measuring component 300 rises steadily, it indicates that the expandable component 200 can effectively block the venous orifice 510. When the temperature detected by the temperature measuring component 300 rises rapidly, it indicates that the expandable component 200 cannot effectively block the venous orifice 510. At this time, there is a leak at least at one place in the expandable component 200, and the orientation of the cryoablation catheter 10 needs to be adjusted until the expandable component 200 effectively blocks the venous orifice 510. At the same time, the mild liquid will not cause damage to the blood vessels, can effectively avoid the situation that the patient is intolerant to the contrast agent, reduce the X-ray irradiation, and avoid damage to the patient and the operator, such as Figure 4 and Figure 5 shown.

[0068] See Figures 1 to 5, when the cryoablation catheter 10 is in use, the distal end of the cryoablation catheter 10 is inserted into a blood vessel, and the elongated body 100 is pushed, so that the expandable assembly 200 is pushed to the venous orifice 510. Subsequently, gas is delivered from the gas flow channel 130 to the expandable assembly 200, so that the expandable assembly 200 switches from the contracted configuration to the expanded configuration. At this time, the expandable assembly 200 can block the venous orifice 510. After the expandable assembly 200 blocks the venous orifice 510, it is necessary to determine the effectiveness of the blockage of the venous orifice 510. The mild liquid is delivered from the first delivery channel into the vein 50. The temperature measurement assembly 300 detects the blood temperature of the venous orifice 510 and feeds it back to the controller to determine whether the expandable assembly 200 effectively blocks the venous orifice 510. After complete blockage, a refrigerant is delivered to the expandable assembly 200 through the second delivery channel, so that the cryoablation catheter 10 can perform cryoablation on the lesion site near the venous orifice 510 to achieve the purpose of treatment.

[0069] For the cryoablation catheter 10 of the above embodiment, the expandable assembly 200 is expanded by delivering gas through the gas flow channel 130 of the main body tube 120, so that the expandable assembly 200 is in the expanded configuration and blocks the venous orifice 510. During cryoablation, cryoablation operations can be achieved through the cooperation of the gas flow channel, the second delivery channel and the expandable assembly 200. Moreover, before ablation, the cryoablation catheter 10 delivers harmless mild liquid into the vein 50 through the first delivery channel. The temperature measurement assembly 300 on the expandable assembly 200 can be used to measure the temperature change to judge the blocking state this time, so as to judge whether there is leakage between the expandable assembly 200 and the venous orifice 510, and it can also reduce the usage amount of contrast agent and X-rays, and avoid harming the health of doctors and patients. At the same time, the specific position of the leakage can be judged through the temperature measurement assembly 300, which can then help the operator quickly rotate and / or move to adjust the direction and position of the expandable assembly 200 for effective blockage, facilitating subsequent ablation treatment and ensuring the treatment effect.

[0070] Optionally, the mild liquid is normal saline, balanced salt solution or other types of mild liquid. In this embodiment, the mild liquid is normal saline that is harmless at room temperature. Using normal saline to replace the contrast agent can cooperate with the temperature measurement assembly 300 to judge whether the expandable assembly 200 effectively blocks the venous orifice 510, and at the same time can avoid the intolerance caused by using the contrast agent and reduce X-ray irradiation. Of course, in other embodiments of the present application, the mild liquid can also be a balanced salt solution or other types of mild liquid, as long as it can cooperate with the temperature measurement assembly 300 to judge whether the blockage is effective.

[0071] See Figure 2, optionally, the main body tube 120 has a spiral opening 121, and the spiral opening 121 communicates the second delivery channel with the air flow channel 130. In this way, the refrigerant in the second delivery channel can enter the expandable assembly 200 in a spiral direction through the spiral opening 121, so that the refrigerant can be delivered to the expandable assembly 200 from all directions to meet the cryoablation requirements. Optionally, the cryoablation catheter 10 further includes a control handle 400, and the control handle 400 is disposed at the proximal end of the elongated body 100. The control handle 400 is used to control the movement of the elongated body 100 to push the cryoablation catheter 10 to the desired position. Optionally, the cryoablation catheter 10 further includes a flexible tube 140, and the flexible tube 140 is disposed at the distal end of the elongated body 100 and is located at the distal end of the expandable assembly 200. The flexible tube 140 can play a role of flexible guiding and avoid scratching blood vessels. Optionally, the control handle 400 has an electrical interface 410, and the electrical interface 410 is disposed at the proximal end of the control handle 400 and is electrically connected to the temperature measurement assembly 300 through a lead wire. The lead wire is arranged in an insulated manner in the air flow channel 130, or a wiring channel is formed through an insulating tube, or the wire is routed through the outer tube 110 or the main body tube 120.

[0072] See Figure 2 , optionally, the control handle 400 further includes a first interface 420, and the first interface 420 is disposed at the proximal end of the control handle 400 and communicates with the proximal end of the second delivery channel to deliver refrigerant to the second delivery channel. The first interface 420 is connected to a storage tank storing refrigerant in the refrigeration device 60. Optionally, the control handle 400 further includes a second interface 430, and the second interface 430 is disposed at the proximal end of the control handle 400 and communicates with the proximal end of the first delivery channel to deliver a mild liquid to the first delivery channel. Of course, the first delivery channel can also be passed through by a guiding instrument. Optionally, the elongated body 100 further includes a temperature sensor 150, and the temperature sensor 150 is disposed on the outer wall of the main body tube 120 and is located in the expandable assembly 200. The temperature sensor 150 is used to measure the temperature of cryoablation. Optionally, the cryoablation catheter 100 further includes a visualization member 160, and the visualization member 160 is disposed on the outer tube 110 to locate the cryoablation catheter 10 in the blood vessel and ensure that the distal end of the cryoablation catheter 10 can accurately move to the venous orifice 510.

[0073] See Figures 5 to 7 , the expandable assembly 200 includes a first expandable element 210 and a second expandable element 220. The first expandable element 210 covers the second expandable element 220. The inner cavity of the second expandable element 220 communicates with the air flow channel 130. The temperature measurement assembly 300 is disposed between the first expandable element 210 and the second expandable element 220 and is disposed on the outer wall of the second expandable element 220. Figure 6 For Figure 5Top view of one embodiment of the distal end of the cryoablation catheter 10 shown Figure 7 is Figure 5 Top view of another embodiment of the distal end of the cryoablation catheter 10 shown

[0074] Both the first expandable element 210 and the second expandable element 220 have a contracted configuration and an expanded configuration, and are sleeved. The first expandable element 210 is sleeved outside the second expandable element 220, and the inner wall of the first expandable element 210 is attached to the outer wall of the second expandable element 220. In this way, a double-layer expandable assembly 200 is formed. After the gas enters the air flow channel 130, it can enter the inner cavity of the second expandable element 220, and control the second expandable element 220 to gradually switch from the contracted configuration to the expanded configuration. During the expansion process of the second expandable element 220, it can drive the first expandable element 210 to expand, so that the expandable assembly 200 is in the expanded configuration as a whole. At this time, the first expandable element 210 can contact the venous orifice 510 to achieve occlusion of the venous orifice 510

[0075] When the second delivery channel delivers the refrigerant to the inside of the second expandable element 220, the refrigerant can perform cryoablation operations on the surrounding diseased sites at the venous orifice 50, and the gaseous refrigerant after cryoablation flows out through the air flow channel. The temperature measurement assembly 300 is arranged on the outer wall of the second expandable element 220 and is attached to the inner wall of the first expandable element 210. The temperature measurement assembly 300 can detect the temperature of the venous orifice 510 in real time. At the same time, the first expandable element 210 can also play a protective role to protect the temperature measurement assembly 300 and the second expandable element 220. Optionally, both the first expandable element 210 and the second expandable element 220 are balloons or other components that can achieve expansion and contraction

[0076] See Figures 5 to 7 , in one embodiment, the number of the temperature measurement assemblies 300 is multiple, and the multiple temperature measurement assemblies 300 are arranged on the expandable assembly 200. The multiple temperature measurement assemblies 300 are arranged on the outer wall of the second expandable element 220, and the temperature measurement assemblies 300 extend from the proximal end to the distal end, and there is a spacing between adjacent temperature measurement assemblies 300. That is to say, the multiple temperature measurement assemblies 300 can detect the temperatures at different positions. After the expandable assembly 200 contacts the venous orifice 510, the multiple temperature measurement assemblies 300 contact the venous orifice 510 in the circumferential direction of the venous orifice 510. In this way, the multiple temperature measurement assemblies 300 can monitor the temperatures at different positions of the venous orifice 510 to detect the occlusion effectiveness of each position in the circumferential direction of the expandable assembly 200

[0077] After the expandable component 200 seals the venous orifice 510, multiple temperature measuring components 300 are distributed at different positions of the venous orifice 510. After introducing mild liquid, each temperature measuring component 300 can respectively obtain the temperature change at the corresponding position of the venous orifice 510. If the temperatures obtained by each temperature measuring component 300 steadily rise, the controller determines that the expandable component 200 effectively seals the venous orifice 510. When the temperature obtained by at least one temperature measuring component 300 rapidly rises, it indicates that there is a gap between the expandable component 200 and the venous orifice 510 at the position corresponding to this temperature measuring component 300, and the situation of ineffective sealing occurs. At this time, the direction and position of the expandable component 200 need to be adjusted until the temperatures obtained by each temperature measuring component 300 steadily rise to effectively seal the venous orifice 510.

[0078] In one embodiment, there is a spacing between adjacent temperature measuring components 300, or multiple temperature measuring components 300 cover the expandable component 200. That is to say, multiple temperature measuring components 300 are arranged on the expandable component 200 with a spacing. As long as it is ensured that the multiple temperature measuring components 300 are circumferentially distributed on the expandable component 200 to meet the temperature detection at each position in the circumferential direction of the expandable component 200. Of course, multiple temperature measuring components 300 can also be arranged densely on the expandable component 200 to achieve the temperature detection at each position in the circumferential direction of the expandable component 200.

[0079] See Figures 5 to 7 , in one embodiment, the temperature measuring component 300 includes a temperature measuring element 320 and a fixing component 310. The fixing component 310 fixes the temperature measuring element 320 to the expandable component 200, and the temperature measuring element 320 and the fixing component 310 are stretched as the expandable component 200 expands. The temperature measuring element 320 is arranged on one surface of the fixing component 310, and the fixing component 310 is arranged on the second expandable element 220, thereby fixing the temperature measuring element 320 to the second expandable element 220. During the expansion of the second expandable element 220, it can drive the fixing component 310 and the temperature measuring element 320 to stretch synchronously, so that the temperature measuring element 320 can contact the blood to meet the temperature measurement requirements. Optionally, the fixing component 310 is strip-shaped after stretching, and the temperature measuring element 320 is arranged on the fixing component 310. Optionally, the temperature measuring element 320 is adsorbed and fixed to the outer wall of the second expandable element 220 through the fixing component 310.

[0080] See Figures 5 to 7, in one embodiment, the temperature measuring element 320 includes a linear element 322 and a temperature measuring point 321. The linear element 322 is disposed on the fixed member 310. The distal end of the linear element 322 is electrically connected to the temperature measuring point 321 for transmitting the temperature signal detected by the temperature measuring point 321. The proximal end of the linear element 322 is electrically connected to the controller through a lead wire, so that the temperature signal detected by the temperature measuring element 320 is fed back to the controller, facilitating the controller to determine whether the venous orifice 510 is effectively blocked. The temperature measuring point 321 is disposed at the end or middle of the linear element 322 to facilitate the detection of the blood temperature. Moreover, the temperature measuring point 321 can be at any position of the linear element 322.

[0081] It should be noted that the temperature measuring point 321 can be at any position of the second expandable assembly 200. Optionally, the temperature measuring point 321 is located on the distal spherical surface of the expandable assembly 200. In this way, when the expandable assembly 200 blocks the venous orifice 510, the temperature measuring point 321 is as much as possible located in the vein 50 to ensure the temperature measuring effect. Optionally, the temperature measuring point 321 is disposed in the distal or middle region of the linear element 322. Optionally, the temperature measuring point 321 is a temperature measuring solder joint or a temperature measuring sensor, etc. Of course, in other embodiments of the present application, the temperature measuring point 321 can also be disposed on the flexible tube 140.

[0082] See Figures 5 to 7 , in one embodiment, the cryoablation catheter 10 further includes a marking point 330. The marking point 330 is disposed on the fixed member 310. The marking point 330 can mark the relative position of the temperature measuring element 320 in the expandable assembly 200 under X-ray. The marking point 330 can mark the positions and directions of different temperature measuring elements 320, facilitating the operator to identify. When there is a gap between the expandable assembly 200 where the temperature measuring assembly 300 is located and the venous orifice 510, the leakage position can be accurately determined by identifying the marking point 330, facilitating the adjustment of the expandable assembly 200. The marking point 330 is identified in cooperation with X-ray. Optionally, the marking point 330 is made of a material that can be developed under X-ray.

[0083] In one embodiment, each fixed member 310 has at least one marking point 330, and the marking points 330 on each fixed member 310 are different from each other. That is to say, different marking points 330 are set on each fixed member 310. The position of the corresponding temperature measuring assembly 300 can be identified through the corresponding marking point 330 to determine whether the expandable assembly 200 at that position effectively seals the venous orifice 510. Once the temperature of a certain temperature measuring assembly 300 rises rapidly, the controller can easily determine that the expandable assembly 200 at that temperature measuring assembly 300 is not effectively blocked, and then adjust the orientation of the expandable assembly 200 until the expandable assembly 200 completely blocks the venous orifice 510.

[0084] See Figures 5 to 7, in one embodiment, at least part of the fixing member 310 has at least one marking point 330. Among the fixing members 310 having the marking point 330, the marking points 330 on each fixing member 310 are different. That is to say, only part of the fixing members 310 have different marking points 330, and there are no marking points 330 on the remaining fixing members 310. At this time, the fixing members 310 with marking points 330 can be positioned through the marking points 330 thereon. The fixing members 310 without marking points 330 can be positioned through the adjacent fixing members 310 with marking points 330. As Figure 6 and Figure 7 shown, some of the fixing members 310 have marking points 330, and some of the fixing members 310 do not have marking points 330.

[0085] See Figures 5 to 7 , in one embodiment, at least one of the number, shape and / or length of the marking points 330 on each fixing member 310 having the marking point 330 is different. That is to say, among the fixing members 310 having the marking point 330, the marking points 330 of each fixing member 310 are different from each other, so as to facilitate distinguishing the relative positions of the expandable components 200 corresponding to the marking points 330. Exemplarily, as Figure 6 shown, the marking points 330 among the fixing members 310 having the marking point 330 are distinguished by different numbers. Exemplarily, the marking points 330 among the fixing members 310 having the marking point 330 are distinguished by different lengths.

[0086] See Figures 5 to 7 , in one embodiment, the fixing members 310 having the marking point 330 are arranged adjacent to each other, and at least one fixing member 310 having the marking point 330 is arranged between adjacent fixing members 310 without the marking point 330, and at least one fixing member 310 without the marking point 330 is arranged between adjacent fixing members 310 having the marking point 330. That is to say, at least one fixing member 310 without the marking point 330 is arranged between two adjacent fixing members 310 having the marking point 330, and at least one fixing member 310 having the marking point 330 is arranged between two adjacent fixing members 310 without the marking point 330.

[0087] See Figures 5 to 7 , exemplarily, the fixing members 310 having the marking point 330 and the remaining fixing members 310 are arranged alternately. That is to say, one fixing member 310 without the marking point 330 is arranged between two adjacent fixing members 310 having the marking point 330, and one fixing member 310 having the marking point 330 is arranged between two adjacent fixing members 310 without the marking point 330. In this way, it is convenient to judge the positions of the respective temperature measuring components 300 on the expandable component 200, so as to facilitate judging the effectiveness of the plugging.

[0088] To facilitate the description of the principle of effective plugging of multiple temperature measuring components 300, the number of temperature measuring components 300 is recorded as 6 here. Among them, three with marking points 330 are the first temperature measuring element MT1, the second temperature measuring element MT2, and the third temperature measuring element MT3 respectively, and the three without marking points 330 are the fourth temperature measuring element MT4, the fifth temperature measuring element MT5, and the sixth temperature measuring element MT6 respectively. The first temperature measuring element MT1, the second temperature measuring element MT2, and the third temperature measuring element MT3 are arranged alternately with the fourth temperature measuring element MT4, the fifth temperature measuring element MT5, and the sixth temperature measuring element MT6. The fourth temperature measuring element MT4 is arranged between the first temperature measuring element MT1 and the second temperature measuring element MT2, the fifth temperature measuring element MT5 is arranged between the second temperature measuring element MT2 and the third temperature measuring element MT3, and the sixth temperature measuring element MT6 is arranged between the first temperature measuring element MT1 and the third temperature measuring element MT3.

[0089] The marking points 330 on the first temperature measuring element MT1, the second temperature measuring element MT2, and the third temperature measuring element MT3 are different. As Figure 6 shown, the first temperature measuring element MT1 has one marking point 330, the second temperature measuring element MT2 has two marking points 330, and the third temperature measuring element MT3 has three marking points 330. As Figure 7 shown, the marking points 330 on the first temperature measuring element MT1, the second temperature measuring element MT2, and the third temperature measuring element MT3 are arranged in a strip shape, and the lengths increase in sequence.

[0090] When the expandable component 200 completely plugs the venous orifice 510, the temperatures of the first temperature measuring element MT1 to the sixth temperature measuring element MT6 rise steadily after a preset time of introducing mild liquid. At this time, the expandable component 200 effectively plugs the venous orifice 510. Assume that the expandable component 200 does not completely plug the venous orifice 510 at the first temperature measuring element MT1, and blood will flow out from the gap between the expandable component 200 and the venous orifice 510 at the first temperature measuring element MT1. The temperature detected by the first temperature measuring element MT1 rises rapidly. At the same time, the temperature rise between the second temperature measuring element MT2 and the third temperature measuring element MT3 is stable. In this way, it indicates that the expandable component 200 does not effectively plug the venous orifice 510, and it leaks at the first temperature measurement point and is effectively plugged at the other temperature measurement points. At this time, adjust the orientation of the expandable component 200 so that the expandable component 200 is effectively plugged at each temperature measuring element. The principle of leakage of the second temperature measuring element MT2 and the third temperature measuring element MT3 is essentially the same and will not be elaborated here.

[0091] When the expandable component 200 does not completely block the venous orifice 510 at the fourth temperature measuring element MT4, the temperature detected by the fourth temperature measuring element MT4 rises rapidly. Since the fourth temperature measuring element MT4 is located between the first temperature measuring element MT1 and the second temperature measuring element MT2, and since the first temperature measuring element MT1 and the second temperature measuring element MT2 effectively block, if there is a leak between the first temperature measuring element MT1 and the second temperature measuring element MT2, it indicates that the venous orifice 510 is not effectively blocked at the fourth temperature measuring element MT4. When effectively blocked at other positions, adjust the orientation of the expandable component 200 so that the expandable component 200 effectively blocks at each temperature measuring element. The principle of leakage of the fifth temperature measuring element MT5 and the sixth temperature measuring element MT6 is essentially the same and will not be elaborated here.

[0092] See Figure 3 and Figure 8 , Figure 8 is Figure 2 the temperature change curve of the temperature rise of the temperature measuring assembly 300 after the cryoablation catheter 10 shown is effectively blocked. When the expandable component 200 completely blocks the venous orifice 510, the blood in the vein 50 cannot flow into the atrium. After injecting a certain amount of warm liquid into the main tube 120 through the first delivery channel, the warm liquid flows into the blood in the vein 50 through the distal end of the first delivery channel. At this time, the warm liquid cannot flow into the atrium. As the warm liquid and the blood are gradually mixed, the temperature in the vein 50 gradually decreases from the initial temperature of the blood. At this time, the first temperature measuring element MT1, the second temperature measuring element MT2, and the third temperature measuring element MT3 record the temperature change, and the recorded data is calculated and judged by the controller, and finally the blocking state of the expandable component 200 is displayed on the display screen. Generally, the judgment logic is: starting from the temperature measured by each temperature measuring point 321 on the balloon surface dropping to the lowest temperature, calculate the rate or amplitude of the temperature rise within a certain time to judge the blocking state of the vein 50. In this case of complete blockage, since the blood in the vein 50 cannot flow into the left atrium, after injecting a certain amount of normal saline, after the temperature of the venous orifice 510 drops to the lowest point, it will maintain for a period of time or slowly rise under the influence of body temperature, and the rising amplitude is small within a certain time. Figure 8 is the surface temperature change curve when the balloon is completely blocked, and the temperature of each point on the surface rises slowly within 20 s. Measure the decreasing temperature of the blood through the temperature measuring assembly 300. When the blood drops to the lowest temperature, the temperature of the blood will maintain for a period of time or slowly rise under the influence of body temperature, and the rising amplitude is small within a certain time. That is, after the expandable component 200 completely blocks the venous orifice 510, the temperature measuring assembly 300 starts to rise steadily after detecting the lowest temperature, indicating that the expandable component 200 effectively blocks the venous orifice 510, as Figure 3 and Figure 8 shown. After 20 s, the temperature of each temperature measuring element rises slowly.

[0093] SeeFigure 4 and Figure 9 , Figure 9 is Figure 2 the temperature change curve of the temperature rise of the temperature measurement component 300 after the cryoablation catheter 10 shown in the figure is not effectively blocked. When the expandable component 200 does not completely block the venous orifice 510, there is a certain gap between the venous orifice 510 and the expandable component 200, and the blood in the vein 50 flows from the gap into the atrium. After the expandable component 200 is inflated and in the expandable configuration, a certain amount of mild liquid is injected into the main body tube 120 through the first delivery channel. After the mild liquid flows into the blood of the vein 50 through the distal end of the first delivery channel, after the mild liquid is gradually mixed with the blood, part of it will flow into the atrium from the gap between the expandable component 200 and the venous orifice 510. Under the scouring of the blood flow, after the temperature of the venous orifice 510 drops to the lowest point, it will rise at a relatively fast rate and the rising amplitude is relatively large within a certain period of time, and the expandable component 200 does not completely block the venous orifice 510. As Figure 4 and Figure 9 shown, the temperature detected by the first temperature measuring element MT1 rises rapidly, and the temperature rise speeds at the second temperature measuring element MT2 and the third temperature measuring element MT3 are relatively gentle. According to Figure 9 the shown temperature curve, it can be judged that a leak occurs at the first temperature measuring element MT1. Under the action of the marking point 330 of the first temperature measuring element MT1, according to the position of the first temperature measuring element MT1 in the vein 50, the operator can ensure the complete blockage of the venous orifice 510 by adjusting the orientation of the expandable component 200.

[0094] For the cryoablation catheter 10 of the present application, the expandable component 200 is inflated by delivering gas through the gas flow channel 130 of the main body tube 120, so that the expandable component 200 is in the inflated configuration and blocks the venous orifice 510. During the cryoablation process, the cryoablation operation can be realized through the cooperation of the gas flow channel, the second delivery channel and the expandable component 200. Moreover, before ablation, the cryoablation catheter 10 delivers harmless mild liquid into the vein 50 through the first delivery channel, and the temperature change can be measured by the temperature measurement component 300 on the expandable component 200 to judge the blockage state of this time, so as to judge whether there is a leak between the expandable component 200 and the venous orifice 510, and it can also reduce the usage amount of contrast agent and X-ray, and avoid harming the health of doctors and patients. At the same time, the specific position of the leak can be judged through the temperature measurement component 300, which can then help the operator quickly rotate and / or move to adjust the direction and position of the expandable component 200 for effective blockage, facilitating the subsequent ablation treatment and ensuring the treatment effect.

[0095] See Figures 1 to 5, the present application further provides a control method for the cryoablation catheter 10, which is applied to the cryoablation catheter 10 in any of the above embodiments. The control method includes the following steps:

[0096] Insert the distal end of the cryoablation catheter 10 into the venous orifice 510;

[0097] Deliver gas to the expandable component 200 to expand the expandable component 200 to block the venous orifice 510;

[0098] Inject a mild liquid into the vein 50 and mix it with the blood in the vein 50;

[0099] The temperature measurement component 300 obtains the temperature of the venous orifice 510 and feeds it back to the controller of the cryo device 60. The controller determines whether the expandable component 200 effectively blocks the venous orifice 510 according to the temperature rise rate of the venous orifice 510.

[0100] See Figures 1 to 5 , when the cryoablation catheter 10 is in use, insert the distal end of the cryoablation catheter 10 into the blood vessel and push the slender body 100 so that the expandable component 200 moves to the venous orifice 510. Subsequently, gas is delivered from the air flow channel 130 to the expandable component 200 to cause the expandable component 200 to switch from the contracted configuration to the expanded configuration. At this time, the expandable component 200 can block the venous orifice 510. After the expandable component 200 blocks the venous orifice 510, it is necessary to determine the effectiveness of the blockage of the venous orifice 510. The mild liquid is delivered from the first delivery channel into the vein 50. The temperature measurement component 300 detects the blood temperature of the venous orifice 510 and feeds it back to the controller to determine whether the expandable component 200 effectively blocks the venous orifice 510.

[0101] When determining whether it is effectively blocked, the controller determines that when the temperature detected by the temperature measurement component 300 rises steadily, it indicates that the expandable component 200 can effectively block the venous orifice 510. When the temperature detected by the temperature measurement component 300 rises rapidly, it indicates that the expandable component 200 cannot effectively block the venous orifice 510. At this time, there is a leak at at least one place in the expandable component 200, and it is necessary to adjust the orientation of the cryoablation catheter 10 until the expandable component 200 effectively blocks the venous orifice 510. At the same time, the mild liquid will not damage the blood vessel, can effectively avoid the situation where the patient is intolerant to the contrast agent, reduce the X-ray irradiation, and avoid damage to the patient and the operator, as Figure 4 and Figure 5 shown. After complete blockage, the cryoablation catheter 10 performs cryoablation on the lesion site near the venous orifice 510 to achieve the purpose of treatment.

[0102] In one embodiment, the controller determines whether the inflatable component 200 effectively seals the venous orifice 510 according to the temperature change of the venous orifice 510, including the following steps:

[0103] After injecting mild liquid into the vein 50, the temperature measuring component 300 obtains the first temperature after the mild liquid and blood are mixed at the venous orifice 510;

[0104] After a preset time, the temperature measuring component 300 obtains the second temperature of the venous orifice 510 and feeds it back to the controller. The second temperature is greater than the first temperature. The controller determines whether the inflatable component 200 effectively seals the venous orifice 510 according to the rising rate from the first temperature to the second temperature.

[0105] The blood has an initial temperature in the vein 50. After the inflatable component 200 seals the venous orifice 510, the temperature measuring component 300 obtains the initial temperature of the venous orifice 510 and feeds it back to the controller. Mild liquid is introduced into the vein 50, and the mild liquid is mixed with the blood. The temperature measuring component 300 detects that the temperature of the blood in the vein 50 drops to the first temperature, and the first temperature is lower than the initial temperature. The first temperature is the lowest temperature after the mild liquid and blood are mixed. After a preset time, the temperature measuring component 300 detects that the temperature of the blood in the vein 50 rises, and records this temperature as the second temperature, and the second temperature is higher than the first temperature. At this time, the controller can determine whether the seal is effective according to the rising rate from the first temperature to the second temperature. When the controller determines that the second temperature rises steadily, the inflatable component 200 effectively seals the venous orifice 510. When the controller determines that the second temperature rises rapidly, the inflatable component 200 does not effectively seal the venous orifice 510.

[0106] In one embodiment, when the controller determines whether the inflatable component 200 effectively seals the venous orifice 510 according to the rising rate of the second temperature, it further includes the following steps:

[0107] When the controller determines that the second temperature is at the first rising rate, the controller determines that the inflatable component 200 effectively seals the venous orifice 510;

[0108] When the controller determines that the second temperature is at the second rising rate, the controller determines that the inflatable component 200 does not effectively seal the venous orifice 510;

[0109] Wherein, the first rising rate is less than the second rising rate.

[0110] When the controller determines that the second temperature rises at the first rising rate, the second temperature rises steadily, and the inflatable component 200 effectively seals the venous orifice 510. When the controller determines that the second temperature rises at the second rising rate, the second temperature rises rapidly, and the inflatable component 200 does not effectively seal the venous orifice 510.

[0111] In one embodiment, there are multiple temperature measurement components 300, which are arranged on the expandable component 200 and circumferentially distributed to contact the inner wall of the venous orifice 510. The control method further includes the following steps:

[0112] Each temperature measurement component 300 respectively obtains the temperature at the corresponding position of the venous orifice 510;

[0113] After injecting the mild liquid, if the temperatures obtained by each temperature measurement component 300 steadily rise, the expandable component 200 effectively blocks the venous orifice 510;

[0114] If the temperature obtained by at least one temperature measurement component 300 rapidly rises, there is a leak at the expandable component 200 at the corresponding temperature measurement component 300;

[0115] Rotate the cryoablation catheter 10 until the temperatures obtained by each temperature measurement component 300 steadily rise.

[0116] After the expandable component 200 blocks the venous orifice 510, multiple temperature measurement components 300 are distributed at different positions of the venous orifice 510. After injecting the mild liquid, each temperature measurement component 300 can respectively obtain the temperature at the corresponding position of the venous orifice 510. If the temperatures obtained by each temperature measurement component 300 steadily rise, the controller determines that the expandable component 200 effectively blocks the venous orifice 510. If the temperature obtained by at least one temperature measurement component 300 rapidly rises, it indicates that there is a gap at the position corresponding to the temperature measurement component 300 between the expandable component 200 and the venous orifice 510, and the situation of ineffective blocking occurs. At this time, it is necessary to adjust the direction and position of the expandable component 200 until the temperatures obtained by each temperature measurement component 300 steadily rise to effectively block the venous orifice 510.

[0117] See Figure 1 , the present application also provides a cryoablation system, including a cryo device 60, a display control device 70, and the cryoablation catheter 10 with any of the above technical features. The display control device 70 is connected to the cryo device 60. The proximal end of the control handle 400 of the cryoablation catheter 10 is connected to the cryo device, and the distal end extends into the venous orifice 510 for blocking the venous orifice 510. After adopting the cryoablation catheter 10 of the above embodiment in the cryoablation system of the present application, the cryoablation catheter 10 uses the method of delivering mild liquid to cooperate with temperature measurement to judge whether it is effectively blocked, reducing the usage amount of contrast agent and X-ray. When a leak occurs, it is convenient to judge the specific position of the leak for effective blocking to ensure the treatment effect. The cryo device 60 has a controller, the display control device 70 has a display screen, and the controller is electrically connected to the display screen and the temperature measurement component 300 to display the temperature transmitted by the temperature measurement component 300 and the blocking state on the display screen.

[0118] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of 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, it should be considered as falling within the scope described in this specification.

[0119] The above-described embodiments merely represent several implementation manners of the present application. The description thereof is relatively specific and detailed, but it should not be construed as a limitation to the scope of the patent application. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present application, several modifications and improvements can still be made, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application shall be subject to the appended claims.

Claims

1. A cryoablation catheter, characterized in that, It includes a slender body, an inflatable component, and a temperature measuring component. The inflatable component is arranged at the distal end of the slender body and has an inflated configuration and a contracted configuration. When the inflatable component is in the inflated configuration, it can block the venous orifice. The slender body includes an outer tube and a main body tube. The outer tube is sleeved on the main body tube and is connected to the inflatable component at the distal end. The outer tube and the main body tube enclose an air flow channel, and the air flow channel communicates with the inflatable component. The main body tube has a first delivery channel extending axially, and the first delivery channel penetrates through the main body tube for delivering warm liquid to the vein. The temperature measuring component is arranged on the inflatable component and can detect the temperature of the venous orifice to judge the effectiveness of the blockage by the inflatable component.

2. The cryoablation catheter according to claim 1, wherein The inflatable component includes a first inflatable element and a second inflatable element. The first inflatable element wraps the second inflatable element. The inner cavity of the second inflatable element communicates with the air flow channel. The temperature measuring component is arranged between the first inflatable element and the second inflatable element and on the outer wall of the second inflatable element.

3. The cryoablation catheter according to claim 1, wherein The number of the temperature measuring components is multiple, and the multiple temperature measuring components are arranged on the inflatable component. There is a spacing between adjacent temperature measuring components, or the multiple temperature measuring components cover the inflatable component.

4. The cryoablation catheter according to any one of claims 1 to 3, characterized in that, The temperature measuring component includes a temperature measuring element and a fixing component. The fixing component fixes the temperature measuring element on the inflatable component, and the temperature measuring element and the fixing component are stretched as the inflatable component expands.

5. The cryoablation catheter according to claim 4, wherein The temperature measuring element includes a linear element and a temperature measuring point. The linear element is arranged on the fixing component, and the temperature measuring point is arranged at the distal end or the middle area of the linear element.

6. The cryoablation catheter according to claim 4, wherein The cryoablation catheter further includes a marking point, and the marking point is arranged on the fixing component. The marking point is used to mark the relative position between the temperature measuring element and the venous orifice.

7. The cryoablation catheter according to claim 6, wherein, Each fixing component has at least one marking point, and the marking points on each fixing component are different from each other.

8. The cryoablation catheter according to claim 6, wherein, At least part of the fixing components have at least one marking point. Among the fixing components with marking points, the marking points on each fixing component are different.

9. The cryoablation catheter according to claim 8, wherein The fixing components with marking points are arranged adjacent to each other, and at least one fixing component with a marking point is arranged between adjacent fixing components without marking points. At least one fixing component without a marking point is arranged between adjacent fixing components with marking points.

10. The cryoablation catheter according to claim 6, wherein At least one of the number, shape, and / or length of the marking points on each fixing component with a marking point is different.

11. A control method for a cryoablation catheter, characterized in that, Applied to the cryoablation catheter according to any one of claims 1 to 10, the control method includes the following steps: Insert the distal end of the cryoablation catheter into the venous orifice. Deliver gas to the inflatable component to make the inflatable component expand to block the venous orifice. Inject warm liquid into the vein and mix it with the blood in the vein. The temperature measurement component acquires the temperature of the venous orifice and feeds it back to the controller of the cryogenic device, and the controller determines whether the expandable component effectively seals the venous orifice according to the temperature rise rate of the venous orifice.

12. The control method according to claim 11, wherein, The controller determines whether the expandable component effectively seals the venous orifice according to the temperature change of the venous orifice, including the following steps: After injecting warm liquid into the vein, the temperature measurement component acquires the first temperature after the warm liquid and blood are mixed at the venous orifice. After a preset time, the temperature measurement component acquires the second temperature of the venous orifice and feeds it back to the controller. The second temperature is greater than the first temperature, and the controller determines whether the expandable component effectively seals the venous orifice according to the rise rate from the first temperature to the second temperature.

13. The control method according to claim 12, characterized in that, The controller determines whether the expandable component effectively seals the venous orifice according to the rise rate of the second temperature, and further includes the following steps: When the controller determines that the second temperature is at the first rise rate, the controller determines that the expandable component effectively seals the venous orifice. When the controller determines that the second temperature is at the second rise rate, the controller determines that the expandable component does not effectively seal the venous orifice. Wherein, the first rise rate is less than the second rise rate.

14. The control method according to claim 11, characterized in that, There are multiple temperature measurement components, which are arranged on the expandable component and are circumferentially distributed to contact the inner wall of the venous orifice. The control method further includes the following steps: After injecting warm liquid, each temperature measurement component respectively acquires the temperature at the corresponding position of the venous orifice. If the temperatures acquired by each temperature measurement component rise steadily, the expandable component effectively seals the venous orifice. If the temperature acquired by at least one temperature measurement component rises rapidly, there is a leak at the expandable component at the corresponding temperature measurement component. Rotate the cryoablation catheter until the temperatures acquired by each temperature measurement component rise steadily.

15. A cryoablation system, characterized in that, It includes a cryogenic device, a display control device, and the cryoablation catheter according to any one of claims 1 to 10. The display control device is connected to the cryogenic device. The proximal end of the control handle of the cryoablation catheter is connected to the cryogenic device, and the distal end extends into the venous orifice for sealing the venous orifice.

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