Cryoablation system, cryoablation catheter, and control method therefor

Abstract

The present application relates to a cryoablation system, a cryoablation catheter (10) and a control method therefor. The cryoablation catheter (10) comprises an elongated body (100), an expandable assembly (200) and a temperature measuring assembly (300). The expandable assembly (200) is arranged at the distal end of the elongated body (100); and when the expandable assembly (200) is in an expanded configuration, the expandable assembly can block a venous orifice portion (510). The elongated body (100) comprises an outer tube (110) and a main body tube (120), the outer tube (110) and the main body tube (120) enclosing an airflow channel (130); the main body tube (120) is provided with a first delivery channel; the airflow channel (130) is in communication with the expandable assembly (200); and the first delivery channel penetrates through the main body tube (120) and is used for delivering a mild liquid to a vein (50). The temperature measuring assembly (300) is provided on the expandable assembly (200) and can measure the temperature of the venous orifice portion (510), so as to determine the effectiveness of the blocking achieved by the expandable assembly (200).

Description

Cryoablation system, cryoablation catheter and control method thereof

[0001] Related applications

[0002] This application claims priority to Chinese patent application No. 2024100021389, filed on January 2, 2024, entitled “Cryoablation System, Cryoablation Catheter and Control Method Thereof,” the entire text of which is hereby incorporated by reference. Technical Field

[0003] The present application relates to the technical field of medical equipment, and in particular to a cryoablation system, a cryoablation catheter, and a control method thereof. Background Art

[0004] Patients with atrial fibrillation have a high risk of stroke. When atrial fibrillation occurs, the atria beat irregularly and rapidly, losing their contractile function. Blood easily stagnates in the atria and forms thrombi. The thrombi break off and enter the brain through the arteries, causing a stroke. Through interventional catheters, energy is applied to the pulmonary veins for ablation to isolate the pulmonary vein potential and achieve the therapeutic effect. Cryoballoon ablation is based on anatomical considerations and uses the contact between the balloon and the tissue for freezing. It has the characteristics of being one-time and continuous. Cryoballoons achieve low-temperature ablation mainly through the throttling expansion effect, which refers to the temperature drop caused by the absorption of heat by the expansion of high-pressure fluid when it passes through tiny capillaries to reach a low-pressure area.

[0005] The cryoablation device is the control center for the entire system, primarily consisting of a control panel, a cryocooler storage container, a vacuum system, and related piping. High-pressure refrigerant is stored in a steel cylinder at room temperature, isolated from the outside world. At the start of cryoablation, the refrigerant is pressurized and cooled by the device's built-in device, liquefying and then entering the balloon through a capillary tube. After being ejected through small holes on the capillary tube's surface, the liquefied refrigerant rapidly vaporizes and expands, rapidly removing heat from the balloon's interior, significantly cooling it and producing the cryoablation effect.

[0006] The effectiveness of cryoballoon ablation is based on the balloon's effective occlusion of the pulmonary veins, which completely blocks the blood in the pulmonary veins, allowing the balloon's energy to be effectively transmitted to the tissue during the ablation process. Currently, cryoablation surgery involves delivering contrast agents from the catheter's internal channel to the balloon end, and determining whether there is any leakage of the contrast agent under X-rays to determine whether the balloon has effectively blocked the area. However, this method requires doctors and patients to be exposed to a large amount of X-rays, which poses health risks. In addition, some patients are intolerant to contrast agents (such as allergies to contrast agents or renal insufficiency) and the imaging system can only present two-dimensional images. When there is a leak behind the image, the doctor needs to constantly adjust the position to determine the specific leak location, or the leak location may be obscured, which can easily lead to misjudgment and affect the treatment effect. Summary of the Invention

[0007] Based on this, a cryoablation system, a cryoablation catheter and a control method thereof are provided, which determine whether the blockage is effective by delivering a mild liquid to the vein in combination with temperature measurement, thereby reducing the use of contrast agents and X-rays. When a leak occurs, it is easy to determine the specific location of the leak for effective blockage and ensure the treatment effect.

[0008] A cryoablation catheter comprises an elongated body, an expandable component, and a temperature measurement component. The expandable component is disposed at the distal end of the elongated body and has an expanded configuration and a contracted configuration. The expandable component can occlude a venous ostium when in the expanded configuration.

[0009] The elongated body includes an outer tube and a main tube. The outer tube is sleeved on the main tube and connected to the expandable component at the distal end. The outer tube and the main tube form an air flow channel, which is connected to the expandable component. The main tube has a first delivery channel extending in the axial direction. The first delivery channel passes through the main tube and is used to deliver a mild liquid to the vein.

[0010] The temperature measuring component is arranged on the expandable component and can detect the temperature of the venous opening to judge the effectiveness of the occlusion of the expandable component.

[0011] In one embodiment of the present application, the expandable component includes a first expandable element and a second expandable element, the first expandable element covers the second expandable element, the inner cavity of the second expandable element is connected to the airflow channel, and the temperature measuring component is arranged between the first expandable element and the second expandable element, and is arranged on the outer wall of the second expandable element.

[0012] In one embodiment of the present application, there are multiple temperature measuring components, and the multiple temperature measuring components are arranged on the expandable component;

[0013] There is a distance between adjacent temperature measuring components, or a plurality of temperature measuring components are distributed throughout the expandable component.

[0014] In one 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 to the expandable component, and the temperature measuring element and the fixing component are stretched as the expandable component expands.

[0015] In one embodiment of the present application, the temperature measuring element includes a linear element and a temperature measuring point. The linear element is arranged on the fixed component, and the temperature measuring point is arranged at the distal end or middle area of ​​the linear element.

[0016] In one embodiment of the present application, the cryoablation catheter further includes a marking point, which is provided on the fixing component and is used to mark the relative position of the temperature measuring element and the venous opening.

[0017] In one embodiment of the present application, each of the fixing components has at least one marking point, and the marking points on each of the fixing components are different.

[0018] In one embodiment of the present application, at least some of the fixing components have at least one marking point, and among the fixing components having the marking point, the marking points on each fixing component are different.

[0019] In one embodiment of the present application, the fixing components with the marking points are arranged adjacent to each other, and at least one fixing component with the marking points is set between adjacent fixing components without the marking points, and at least one fixing component without the marking points is set between adjacent fixing components with the marking points.

[0020] In one embodiment of the present application, at least one of the number, shape, and length of the marking points on each of the fixing components having the marking points is different.

[0021] A control method for a cryoablation catheter, applied to a cryoablation catheter according to any of the above technical features, comprises the following steps:

[0022] inserting the distal end of the cryoablation catheter into the ostium of the vein;

[0023] delivering gas to the expandable component to expand the expandable component to occlude the venous ostium;

[0024] A mild fluid is injected into a vein and mixed with the blood in said vein;

[0025] The temperature measuring component obtains the temperature of the venous opening and feeds it back to the controller of the refrigeration equipment. The controller determines whether the expandable component effectively blocks the venous opening based on the temperature rise rate of the venous opening.

[0026] In one embodiment of the present application, the controller determines whether the expandable component effectively blocks the venous opening based on the temperature change of the venous opening, including the following steps:

[0027] After the mild liquid is injected into the vein, the temperature measuring component obtains a first temperature of the mild liquid mixed with blood at the mouth of the vein;

[0028] After a preset time, the temperature measuring component obtains the second temperature of the venous opening and feeds it back to the controller. The second temperature is greater than the first temperature. The controller determines whether the expandable component effectively blocks the venous opening based on the recovery rate from the first temperature to the second temperature.

[0029] In one embodiment of the present application, the controller determines whether the expandable component effectively blocks the venous ostium according to the recovery rate of the second temperature, further comprising the following steps:

[0030] When the controller determines that the second temperature is at a first recovery rate, the controller determines that the expandable component effectively blocks the venous ostium;

[0031] When the controller determines that the second temperature is at a second recovery rate, the controller determines that the expandable component has not effectively blocked the venous ostium;

[0032] The first recovery rate is smaller than the second recovery rate.

[0033] In one embodiment of the present application, the temperature measuring components are multiple and are disposed on the expandable component and are distributed circumferentially to contact the inner wall of the venous opening. The control method further includes the following steps:

[0034] After the warm liquid is injected, each of the temperature measuring components respectively obtains the temperature at the corresponding position of the vein opening;

[0035] If the temperature obtained by each of the temperature measuring components rises steadily, the expandable component effectively blocks the venous opening;

[0036] If the temperature obtained by at least one of the temperature measuring components rises rapidly, the expandable component is leaking at the corresponding temperature measuring component;

[0037] The cryoablation catheter is rotated until the temperature obtained by each temperature measuring component rises steadily.

[0038] A cryoablation system comprises a cryoablation device, a display control device and a cryoablation catheter as described in any of the above technical features, wherein the display control device is connected to the cryoablation device, the proximal end of the control handle of the cryoablation catheter is connected to the cryoablation device, and the distal end extends into the venous orifice for blocking the venous orifice.

[0039] After adopting the above technical solution, this application has at least the following technical effects:

[0040] The cryoablation system, cryoablation catheter and control method thereof of the present application, after the distal end of the cryoablation catheter is delivered to the venous orifice, gas is delivered through the airflow channel to put 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 feed it back to the controller of the freezing equipment, and then deliver a warm liquid to the vein through the first delivery channel. After the warm 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.

[0041] The cryoablation catheter delivers gas to the airflow channel of the main tube to expand 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 a harmless mild liquid to the vein through the first delivery channel. The temperature measuring component on the expandable component can be used to measure the temperature change to determine the current blocking state, so as to determine whether there is a leak between the expandable component and the venous orifice. It can also reduce the use of contrast agents and X-rays, and avoid harm to the health of doctors and patients. At the same time, the specific location of the leak can be determined by the temperature measuring component, which can help the operator quickly rotate and / or move to adjust the direction and position of the expandable component for effective blocking, facilitate the subsequent ablation treatment, and ensure the treatment effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to more clearly illustrate the specific implementation methods of the present application or the technical solutions in the prior art, the following is a brief introduction to the drawings required for use in the specific implementation methods or the description of the prior art. Obviously, the drawings described below are some implementation methods of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0043] FIG1 is a schematic diagram of a cryoablation catheter according to an embodiment of the present application applied to a cryoablation system.

[0044] FIG. 2 is a schematic diagram of the cryoablation catheter shown in FIG. 1 .

[0045] FIG3 is a schematic diagram showing the distal end of the cryoablation catheter shown in FIG2 effectively blocking the venous ostium.

[0046] FIG4 is a schematic diagram showing that the distal end of the cryoablation catheter shown in FIG2 is not effectively blocked at the venous ostium.

[0047] FIG. 5 is a schematic diagram of the expandable component of the cryoablation catheter shown in FIG. 2 in an expanded configuration.

[0048] FIG. 6 is a top view of an embodiment of the distal end of the cryoablation catheter shown in FIG. 5 .

[0049] FIG. 7 is a top view of another embodiment of the distal end of the cryoablation catheter shown in FIG. 5 .

[0050] FIG8 is a temperature change curve of the temperature measuring component after the cryoablation catheter shown in FIG2 is effectively blocked.

[0051] FIG9 is a temperature change curve of the temperature measuring component shown in FIG2 after the cryoablation catheter fails to effectively block the temperature.

[0052] Among them: 10, cryoablation catheter; 100, slender body; 110, outer tube; 120, main body tube; 121, spiral opening; 130, air flow channel; 140, flexible tube; 150, temperature sensor; 160, developing part; 200, expandable component; 210, first expandable element; 220, second expandable element; 300, temperature measuring component; 310, fixing component; 320, temperature measuring element; 321, temperature measuring point; 322, linear element; 330, marking point; MT1, first temperature measuring component; MT2, second temperature measuring component; MT3, third temperature measuring component; MT4, fourth temperature measuring component; MT5, fifth temperature measuring component; MT6, sixth temperature measuring component; 400, control handle; 410, electrical interface; 420, first interface; 430, second interface; 50, vein; 510, venous orifice; 60, freezing equipment; 70, display control equipment. DETAILED DESCRIPTION

[0053] To make the above-mentioned objects, features, and advantages of the present application more clearly understood, the specific embodiments of the present application are described in detail below with reference to the accompanying drawings. The following description sets forth many specific details to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways than those described herein, and those skilled in the art can make similar improvements without violating the scope of the present application. Therefore, the present application is not limited to the specific embodiments disclosed below.

[0054] In the description of the present application, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply 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 understood as a limitation on the present application.

[0055] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of the technical features being referred to. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of such features. Throughout the description of this application, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0056] In this application, unless otherwise specified or limited, the terms "installed," "connected," "connect," "fixed," etc. should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integration; mechanical connection or electrical connection; direct connection or indirect connection through an intermediate medium; internal communication between two elements or interaction between two elements, unless otherwise specified. Those skilled in the art will understand the specific meanings of the above terms in this application based on specific circumstances.

[0057] In this application, unless otherwise expressly specified or limited, when a first feature is "above" or "below" a second feature, it may mean that the first and second features are in direct contact, or the first and second features are in indirect contact through an intermediate medium. Furthermore, when a first feature is "above," "above," or "above" a second feature, it may mean that the first feature is directly above or diagonally above the second feature, or simply means that the first feature is at a higher level than the second feature. When a first feature is "below," "below," or "below" a second feature, it may mean that the first feature is directly below or diagonally below the second feature, or simply means that the first feature is at a lower level than the second feature.

[0058] It should be noted that when an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be an intermediate element. When an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be an intermediate element. The terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used herein are for illustrative purposes only and do not represent the only implementation methods.

[0059] Referring to Figures 1 to 4, the present application provides a cryoablation catheter 10. Figure 1 is a schematic diagram of a cryoablation catheter 10 according to one embodiment of the present application, applied to a cryoablation system. Figure 2 is a schematic diagram of the cryoablation catheter 10 shown in Figure 1. Figure 3 is a schematic diagram of the distal end of the cryoablation catheter 10 shown in Figure 2 effectively blocking the ostium 510 of a vein. Figure 4 is a schematic diagram of the distal end of the cryoablation catheter 10 shown in Figure 2 not effectively blocking the ostium 510 of a vein. The cryoablation catheter 10 is applied to and connected to the cryoablation system. The distal end of the cryoablation catheter 10 can be inserted into a blood vessel and moved within the vessel until it reaches the ostium 510 of a vein. The cryoablation catheter 10 can block the ostium 510 of the vein and perform cryoablation on the lesion near the ostium 510 to achieve the purpose of treatment. The ostium 510 in the present application refers to the end of the vein 50 where blood flows out. The vein 50 here refers to the pulmonary vein. Of course, in other embodiments of the present application, the cryoablation catheter 10 can also block other veins or other blood vessels to perform ablation treatment on nearby lesions. The following text only uses the cryoablation catheter 10 to block the vein orifice 510 as an example to illustrate.

[0060] It is understandable that the current cryoablation surgery passes contrast agent from the internal channel of the catheter to the end of the balloon, and determines whether the contrast agent has leaked under X-rays, thereby determining whether the balloon is effectively blocked. However, this method requires doctors and patients to be exposed to X-rays for a large amount, which will bring health risks. In addition, some patients are intolerant to contrast agents, and the leakage location is prone to misjudgment, thereby affecting the treatment effect. To this end, the present application provides a new type of cryoablation catheter 10, which delivers a mild liquid to the vein 50 and uses temperature measurement to determine whether it is effectively blocked, avoid leakage, facilitate later ablation treatment, reduce the use of contrast agent and X-rays, avoid harm to the health of doctors and patients, and when a leak occurs, it can be easy to determine the specific location of the leak for effective blocking to ensure the treatment effect. The following introduces the specific structure of the cryoablation catheter 10 of one embodiment.

[0061] Referring to Figures 1 to 5, in one embodiment, a cryoablation catheter 10 includes an elongated body 100, an expandable assembly 200, and a temperature measurement assembly 300. The expandable assembly 200 is disposed at the distal end of the elongated body 100 and has an expanded configuration and a contracted configuration. When in the expanded configuration, the expandable assembly 200 can occlude a vein ostium 510. The elongated body 100 includes an outer tube 110 and a main tube 120. The outer tube 110 is sleeved within the main tube 120 and connected to the expandable assembly 200 at its distal end. The outer tube 110 and the main tube 120 enclose an airflow channel 130. The main tube 120 has an axially extending first delivery channel that communicates with the expandable assembly 200. The first delivery channel 130 passes through the main tube 120 and is used to deliver a warm liquid to the vein 50. The temperature measurement assembly 300 is disposed within the expandable assembly 200 and is capable of detecting the temperature of the vein ostium 510 to determine the effectiveness of the expandable assembly 200 in occluding the vein. FIG5 is a schematic diagram of the expandable component 200 in the cryoablation catheter 10 shown in FIG2 in an expanded configuration.

[0062] The elongated body 100 extends along its length and has a proximal end and a distal end disposed in opposite directions. The proximal end refers to the end of the elongated body 100 that is closer to the operator, and the distal end refers to the end of the elongated body 100 that is farther from the operator and closer to the patient. The axial direction, or longitudinal direction, refers to the direction of the line connecting the proximal and distal ends. It is worth noting that the proximal and distal ends of the elongated body 100 also apply to other components and will not be discussed further below. An expandable assembly 200 is disposed at the distal end of the elongated body 100. The distal end of the elongated body 100 is capable of extending into a blood vessel and driving the expandable assembly 200 within the vessel to push the expandable assembly 200 to the venous ostium 510.

[0063] As shown in Figure 2, the outer tube 110 is sleeved on the main tube 120 to form the main structure of the slender body 100. There is a gap between the inner wall of the outer tube 110 and the outer wall of the main tube 120, and an air flow channel 130 is formed. The air flow channel 130 can allow gas and gaseous refrigerant to flow. The distal ends of the outer tube 110 and the main tube 120 are connected to the expandable component 200, forming an annular air flow channel 130 with a proximal opening and a distal closed end. The inner cavity of the expandable component 200 is connected to 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 can facilitate the slender body 100 to drive the expandable component 200 to be pushed in the blood vessel. When the slender body 100 pushes the expandable component 200 to the venous opening 510, and the air flow channel 130 introduces gas into the expandable component 200, the expandable component 200 switches from a contracted configuration to an expanded configuration. At this time, the expandable component 200 can block the venous opening 510, preventing blood from flowing out of the vein 50 through the venous opening 510, so as to facilitate subsequent cryoablation operations.

[0064] The main tube 120 is hollow and has a first delivery channel and a second delivery channel, each of which extends axially. The first delivery channel extends through the main tube 120, with its proximal end extending to the proximal end of the main tube 120 and its distal end extending to the distal end of the main tube 120. Both sides of the first delivery channel are open. After the expandable assembly 200 seals the ostium 510, the distal end of the main tube 120 is located in the vein 50. A mild liquid then enters from the proximal end of the first delivery channel, flows through the first delivery channel, and is delivered 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 has effectively sealed the ostium 510. When the expandable assembly 200 has effectively sealed the ostium 510, it can seal the ostium 510, preventing blood from leaking from the ostium 510. When the expandable component 200 fails to effectively block the venous opening 510, there is a gap between the expandable component 200 and the venous opening 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 component 200 to ensure that the expandable component 200 effectively blocks the venous opening 510, thereby facilitating the subsequent ablation treatment operation.

[0065] There is a certain distance between the second delivery channel and the distal end of the main tube 120. The second delivery channel is connected to the expandable component 200, and the second delivery channel is connected to the airflow channel 130. When inflated, the airflow channel is used to transport gas, and the airflow channel can transport gas to the expandable component 200. At this time, the expandable component 200 can block the venous opening 510. The second delivery channel is used to transport refrigerant, and the airflow channel can also output the refrigerant in a gaseous state after cryoablation. After the expandable component 200 completely blocks the venous opening 510, the second delivery channel can transport refrigerant to the expandable component 200 to perform a cryoablation operation. Specifically, the refrigerant enters from the proximal end of the second delivery channel, and then transports the refrigerant to the inner cavity of the expandable component 200 to perform a cryoablation operation at the venous opening 510. After cryoablation, the refrigerant will become gaseous and flow out from the airflow channel 130.

[0066] Referring to Figures 3 to 5, in order to detect the effectiveness of the blockage, the present application sets a temperature measuring component 300 on the expandable component 200, and the temperature measuring component 300 is electrically connected to the controller of the refrigeration equipment 60. After the expandable component 200 blocks the venous ostium 510, the temperature measuring component 300 is at the venous ostium 510. The temperature measuring component 300 can detect the temperature of the blood in the venous ostium 510 and feed it back to the controller. The controller judges the effectiveness of the expandable component 200 in blocking the venous ostium 510 based on the temperature. When the expandable component 200 effectively blocks the venous ostium 510, ablation treatment can be performed on the lesion area around the venous ostium 510. When the expandable component 200 does not effectively block the venous ostium 510, blood will flow out from the vein 50 through the venous ostium 510. At this time, the direction and position of the expandable component 200 need to be adjusted so that the expandable component 200 blocks the venous ostium 510.

[0067] As can be understood, the logic for determining effective occlusion 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, the rate or amplitude of temperature recovery within a certain period of time is calculated to determine the occlusion status of the expandable component 200 on the vein 50. If the temperature recovers steadily, with a slow recovery rate and a small recovery amplitude, the expandable component 200 has effectively blocked the vein ostium 510. If the temperature recovers rapidly, with a high recovery efficiency and a large recovery amplitude, the expandable component 200 has not effectively blocked the vein ostium 510. The following description will only use the recovery rate as an example. When the recovery rate is fast, the temperature recovers quickly; when the recovery rate is slow, the temperature recovers steadily.

[0068] When the expandable component 200 completely blocks the venous ostium 510, the blood in the vein 50 cannot flow to the atrium. After a certain amount of mild liquid is injected 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 to the atrium. As the mild liquid and the blood gradually mix, the temperature in the vein 50 gradually decreases from the initial temperature of the blood. The temperature drop of the blood is measured by the temperature measuring component 300. When the temperature measuring component 300 measures that the blood has dropped to the lowest temperature, the temperature of the blood will remain for a period of time or slowly recover due to the factor of body temperature, and the recovery rate is small within a certain period of time. That is, after the expandable component 200 completely blocks the venous ostium 510, the temperature measuring component 300 begins to steadily recover after detecting the lowest temperature, indicating that the expandable component 200 effectively blocks the venous ostium 510, as shown in Figures 3 and 5.

[0069] When the expandable component 200 does not completely block the venous ostium 510, a gap exists between the venous ostium 510 and the expandable component 200, allowing blood in the vein 50 to flow through the gap into the atrium. After the expandable component 200 is inflated and in the expanded configuration, a certain amount of warm liquid is injected into the main tube 120 through the first delivery channel. The warm liquid flows through the distal end of the first delivery channel into the blood in the vein 50. After the warm liquid and the blood gradually mix, some of the warm liquid flows into the atrium through the gap between the expandable component 200 and the venous ostium 510. Under the influence of the blood flow, the temperature of the venous ostium 510 drops to a minimum before recovering at a relatively rapid rate, with a significant recovery within a certain period of time. That is, when the expandable component 200 does not completely block the venous ostium 510, the temperature measurement component 300 located at the gap detects that the temperature has dropped to a minimum and then begins to rise rapidly, indicating that the expandable component 200 has not effectively blocked the venous ostium 510. At this time, the location of the gap can be determined based on the difference in the temperature recovery rate of the temperature measuring component 300, and the operator can then adjust the direction and position of the expandable component 200 to ensure that the venous opening 510 is completely blocked.

[0070] The cryoablation catheter 10 uses a mild liquid instead of contrast agent. The temperature measurement component 300 detects surface temperature changes on the expandable component 200 to determine the occlusion status of the venous ostium 510. The final occlusion status is intuitively displayed on the display screen of the display control device 70 via the controller. If the controller determines that the temperature detected by the temperature measurement component 300 has steadily risen, it indicates that the expandable component 200 has effectively sealed the venous ostium 510. If the temperature detected by the temperature measurement component 300 has rapidly risen, it indicates that the expandable component 200 has not effectively sealed the venous ostium 510. In this case, the expandable component 200 has at least one leak, and the cryoablation catheter 10 needs to be adjusted until the expandable component 200 effectively seals the venous ostium 510. Furthermore, the mild liquid does not damage blood vessels, effectively preventing patients from developing intolerance to contrast agents, reducing X-ray exposure, and avoiding harm to the patient and the operator, as shown in Figures 4 and 5.

[0071] 1 to 5 , when the cryoablation catheter 10 is used, the distal end of the cryoablation catheter 10 is inserted into a blood vessel, and the slender body 100 is pushed, so that the expandable component 200 is pushed to the venous ostium 510. Subsequently, gas is delivered from the airflow channel 130 to the expandable component 200, so that the expandable component 200 switches from a contracted configuration to an expanded configuration. At this time, the expandable component 200 is able to block the venous ostium 510. After the expandable component 200 blocks the venous ostium 510, it is necessary to determine the effectiveness of the blockage of the venous ostium 510. A warm liquid is delivered to the vein 50 from the first delivery channel. The temperature measuring component 300 detects the blood temperature at the venous ostium 510 and feeds back to the controller to determine whether the expandable component 200 effectively blocks the venous ostium 510. After complete occlusion, refrigerant is delivered to the expandable component 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.

[0072] In the cryoablation catheter 10 of the above-described embodiment, gas is delivered through the airflow channel 130 of the main tube 120 to expand the expandable component 200, placing the expandable component 200 in the expanded configuration and occluding the venous ostium 510. During the cryoablation process, the coordination of the airflow channel, the second delivery channel, and the expandable component 200 enables cryoablation. Furthermore, before ablation, the cryoablation catheter 10 delivers a harmless, mild liquid into the vein 50 through the first delivery channel. The temperature measurement component 300 on the expandable component 200 can be used to measure temperature changes and determine the current occlusion status, thereby determining whether there is a leak between the expandable component 200 and the venous ostium 510. This can also reduce the use of contrast agents and X-rays, preventing harm to the health of doctors and patients. Furthermore, the temperature measurement component 300 can determine the specific location of the leak, thereby helping the operator quickly rotate and / or move the expandable component 200 to adjust its direction and position for effective occlusion, facilitating subsequent ablation treatment and ensuring therapeutic efficacy.

[0073] Optionally, the mild liquid is physiological saline, balanced salt solution or other types of mild liquids. In this embodiment, the mild liquid is room temperature harmless physiological saline. Using physiological saline instead of contrast agent can be used in conjunction with the temperature measuring component 300 to determine whether the expandable component 200 effectively blocks the venous orifice 510. At the same time, it can also avoid intolerance caused by the use of contrast agents and reduce X-ray exposure. Of course, in other embodiments of the present application, the mild liquid can also be a balanced salt solution or other types of mild liquids, as long as it can be used in conjunction with the temperature measuring component 300 to determine whether it is effectively blocked.

[0074] Referring to Figure 2, optionally, the main tube 120 has a spiral opening 121, and the spiral opening 121 connects the second delivery channel and the airflow channel 130. In this way, the refrigerant in the second delivery channel can enter the expandable component 200 in a spiral direction through the spiral opening 121, so that the refrigerant can be delivered to the expandable component 200 from all directions to meet the needs of cryoablation. Optionally, the cryoablation catheter 10 also includes a control handle 400, which is arranged at the proximal end of the slender body 100. The control handle 400 is used to control the movement of the slender body 100 to push the cryoablation catheter 10 to the desired position. Optionally, the cryoablation catheter 10 also includes a flexible tube 140, which is arranged at the distal end of the slender body 100 and is located at the distal end of the expandable component 200. The flexible tube 140 can play a role of flexible guidance to avoid scratching the blood vessels. Optionally, the control handle 400 has an electrical interface 410, which is disposed at the proximal end of the control handle 400 and is electrically connected to the temperature measurement assembly 300 via a lead wire. The lead wire is arranged in an insulated manner in the airflow channel 130, or forms a wiring channel through an insulating tube, or is routed through the outer tube 110 or the main tube 120.

[0075] Referring to Figure 2, optionally, the control handle 400 also includes a first interface 420, which is arranged at the proximal end of the control handle 400 and is connected to 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 freezing equipment 60. Optionally, the control handle 400 also includes a second interface 430, which is arranged at the proximal end of the control handle 400 and is connected to 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 used for a guide instrument to pass through. Optionally, the slender body 100 also includes a temperature sensor 150, which is arranged on the outer wall of the main tube 120 and is located in the expandable component 200. The temperature sensor 150 is used to measure the temperature of cryoablation. Optionally, the cryoablation catheter 10 further includes a developing member 160 , which is disposed on the outer tube 110 to locate the position of the cryoablation catheter 10 in the blood vessel, ensuring that the distal end of the cryoablation catheter 10 can accurately move to the venous orifice 510 .

[0076] 5 to 7 , expandable assembly 200 includes a first expandable element 210 and a second expandable element 220. First expandable element 210 covers second expandable element 220. The inner lumen of second expandable element 220 communicates with airflow channel 130. Temperature measurement assembly 300 is disposed between first expandable element 210 and second expandable element 220 and on the outer wall of second expandable element 220. FIG. 6 is a top view of one embodiment of the distal end of cryoablation catheter 10 shown in FIG. 5 , and FIG. 7 is a top view of another embodiment of the distal end of cryoablation catheter 10 shown in FIG. 5 .

[0077] The first expandable element 210 and the second expandable element 220 both have contracted and expanded configurations and are nested together. The first expandable element 210 nests around the second expandable element 220, with the inner wall of the first expandable element 210 and the outer wall of the second expandable element 220 in close contact. This creates a double-layer expandable assembly 200. After entering the airflow channel 130, gas flows into the inner cavity of the second expandable element 220, gradually shifting the second expandable element 220 from the contracted configuration to the expanded configuration. The expansion of the second expandable element 220 drives the expansion of the first expandable element 210, placing the entire expandable assembly 200 in the expanded configuration. At this point, the first expandable element 210 contacts the venous ostium 510, effectively blocking it.

[0078] After the second delivery channel delivers the refrigerant to the inner side of the second expandable element 220, the refrigerant can perform a cryoablation operation on the surrounding lesions at the venous orifice 510, and the gaseous refrigerant after cryoablation flows out through the airflow channel 130. The temperature measuring component 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 measuring component 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, protecting the temperature measuring component 300 and the second expandable element 220. Optionally, the first expandable element 210 and the second expandable element 220 are both balloons or other components that can achieve expansion and contraction.

[0079] Referring to Figures 5 to 7, in one embodiment, there are multiple temperature measuring components 300, and multiple temperature measuring components 300 are arranged on the expandable component 200. Multiple temperature measuring components 300 are arranged on the outer wall of the second expandable element 220, and the temperature measuring components 300 extend from the proximal end to the distal end, and there is a distance between adjacent temperature measuring components 300. In other words, multiple temperature measuring components 300 can detect the temperature at different positions. When the expandable component 200 contacts the venous ostium 510, multiple temperature measuring components 300 contact the venous ostium 510 in the circumferential direction of the venous ostium 510. In this way, multiple temperature measuring components 300 can monitor the temperature at different positions of the venous ostium 510 to detect the sealing effectiveness of the expandable component 200 at various circumferential positions.

[0080] After the expandable component 200 blocks the venous opening 510, multiple temperature measuring components 300 are distributed at different positions of the venous opening 510. After the introduction of warm liquid, each temperature measuring component 300 can respectively obtain the temperature change at the corresponding position of the venous opening 510. If the temperature obtained by each temperature measuring component 300 rises steadily, the controller determines that the expandable component 200 has effectively blocked the venous opening 510. If the temperature obtained by at least one temperature measuring component 300 rises rapidly, it means that there is a gap between the expandable component 200 and the venous opening 510 at the position corresponding to the temperature measuring component 300, 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 temperature obtained by each temperature measuring component 300 rises steadily to effectively block the venous opening 510.

[0081] In one embodiment, adjacent temperature measuring assemblies 300 are spaced apart, or multiple temperature measuring assemblies 300 are distributed throughout the expandable assembly 200. In other words, multiple temperature measuring assemblies 300 are spaced apart within the expandable assembly 200. As long as the multiple temperature measuring assemblies 300 are distributed circumferentially around the expandable assembly 200, temperature detection at each location around the expandable assembly 200 is sufficient. Alternatively, multiple temperature measuring assemblies 300 can be distributed throughout the expandable assembly 200 to detect temperature at each location around the expandable assembly 200.

[0082] Referring to Figures 5 to 7, in one embodiment, the temperature measuring assembly 300 includes a temperature measuring element 320 and a fixing member 310. The fixing member 310 secures the temperature measuring element 320 to the expandable assembly 200. The temperature measuring element 320 and the fixing member 310 expand as the expandable assembly 200 expands. The temperature measuring element 320 is disposed on a surface of the fixing member 310, which is disposed on the second expandable element 220, thereby securing the temperature measuring element 320 to the second expandable element 220. The expansion of the second expandable element 220 can cause the fixing member 310 and the temperature measuring element 320 to simultaneously expand, allowing the temperature measuring element 320 to contact blood to meet temperature measurement requirements. Optionally, the fixing member 310, after expansion, is configured in a strip shape, with the temperature measuring element 320 disposed on the fixing member 310. Optionally, the temperature measuring element 320 is fixed to the outer wall of the second expandable element 220 by adsorption of the fixing member 310.

[0083] Referring to 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 component 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 a controller via a lead. The temperature signal detected by the temperature measuring element 320 is fed back to the controller to facilitate the controller's determination of whether the vein ostium 510 is effectively blocked. The temperature measuring point 321 is disposed at the end or middle of the linear element 322 to facilitate blood temperature detection. Furthermore, the temperature measuring point 321 may be located anywhere on the linear element 322.

[0084] It is worth noting that the temperature measuring point 321 can be located at any position on the second expandable component 200. Optionally, the temperature measuring point 321 is located on the distal spherical surface of the expandable component 200. In this way, when the expandable component 200 blocks the venous ostium 510, the temperature measuring point 321 is located as close to the vein 50 as possible to ensure the temperature measurement effect. Optionally, the temperature measuring point 321 is set at the distal end or middle area of ​​the linear element 322. Optionally, the temperature measuring point 321 is a temperature measuring solder point or a temperature measuring sensor. Of course, in other embodiments of the present application, the temperature measuring point 321 can also be set on the flexible tube 140.

[0085] Referring to Figures 5 to 7, in one embodiment, the cryoablation catheter 10 further includes a marking point 330, which is provided on the fixed component 310. The marking point 330 can mark the relative position of the temperature measuring element 320 in the expandable component 200 under X-rays. The marking point 330 can mark the position and direction of different temperature measuring elements 320, which is convenient for the operator to identify. When there is a gap between the expandable component 200 where the temperature measuring component 300 is located and the venous orifice 510, the leakage position can be accurately determined by identifying the marking point 330, which facilitates the adjustment of the expandable component 200. The marking point 330 is identified in conjunction with X-rays. Optionally, the marking point 330 is made of a material that can be developed under X-rays.

[0086] In one embodiment, each fixing component 310 has at least one marking point 330, and each marking point 330 on each fixing component 310 is different. In other words, each fixing component 310 is provided with a different marking point 330. The corresponding marking point 330 can be used to identify the position of the corresponding temperature measuring component 300, thereby determining whether the expandable component 200 at that location is effectively sealing the venous ostium 510. If the temperature of a temperature measuring component 300 rises rapidly, the controller can easily determine that the temperature measuring component 300 is not effectively sealing, and then adjust the position of the expandable component 200 until the expandable component 200 completely seals the venous ostium 510.

[0087] Referring to Figures 5 to 7 , in one embodiment, at least some of the fixing components 310 have at least one marking point 330. Among the fixing components 310 having a marking point 330, the marking points 330 on each fixing component 310 are different. In other words, only some of the fixing components 310 have different marking points 330, while the remaining fixing components 310 do not have a marking point 330. In this case, the fixing components 310 with a marking point 330 can be positioned using the marking point 330 thereon. The fixing components 310 without a marking point 330 can be positioned using an adjacent fixing component 310 with a marking point 330. As shown in Figures 6 and 7 , some of the fixing components 310 have a marking point 330, while others do not.

[0088] Referring to Figures 5 to 7 , in one embodiment, the marking points 330 on each fixing component 310 differ in at least one of the number, shape, and length of the marking points 330. That is, the marking points 330 on each fixing component 310 differ from one another, thereby facilitating identification of the relative positions of the corresponding expandable components 200. For example, as shown in Figure 6 , the marking points 330 on each fixing component 310 differ in number. For example, the marking points 330 on each fixing component 310 differ in length.

[0089] 5 to 7 , in one embodiment, the fixing components 310 having marking points 330 are arranged adjacent to each other, and at least one fixing component 310 having a marking point 330 is disposed between adjacent fixing components 310 not having a marking point 330, and at least one fixing component 310 not having a marking point 330 is disposed between adjacent fixing components 310 having a marking point 330. In other words, at least one fixing component 310 without a marking point 330 is disposed between two adjacent fixing components 310 having a marking point 330, and at least one fixing component 310 with a marking point 330 is disposed between two adjacent fixing components 310 without a marking point 330.

[0090] 5 to 7 , the fixing components 310 with marking points 330 are exemplarily arranged in a staggered arrangement with the remaining fixing components 310. That is, a fixing component 310 without a marking point 330 is disposed between two adjacent fixing components 310 with marking points 330, and a fixing component 310 with a marking point 330 is disposed between two adjacent fixing components 310 without a marking point 330. This facilitates determining the position of each temperature measuring component 300 on the expandable component 200, thereby facilitating the determination of the effectiveness of the blockage.

[0091] To facilitate description of the principle of effective sealing by multiple temperature measuring components 300, the number of temperature measuring components 300 is recorded here as 6, of which three have marking points 330, namely the first temperature measuring component MT1, the second temperature measuring component MT2, and the third temperature measuring component MT3, and the three do not have marking points 330, namely the fourth temperature measuring component MT4, the fifth temperature measuring component MT5, and the sixth temperature measuring component MT6. The first temperature measuring component MT1, the second temperature measuring component MT2, and the third temperature measuring component MT3 are alternately arranged with the fourth temperature measuring component MT4, the fifth temperature measuring component MT5, and the sixth temperature measuring component MT6. The fourth temperature measuring component MT4 is arranged between the first temperature measuring component MT1 and the second temperature measuring component MT2, the fifth temperature measuring component MT5 is arranged between the second temperature measuring component MT2 and the third temperature measuring component MT3, and the sixth temperature measuring component MT6 is arranged between the first temperature measuring component MT1 and the third temperature measuring component MT3.

[0092] The marking points 330 on the first, second, and third temperature-measuring elements MT1, MT2, and MT3 are different. As shown in FIG6 , 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 shown in FIG7 , the marking points 330 on the first, second, and third temperature-measuring elements MT1, MT2, and MT3 are arranged in a strip shape, with increasing length.

[0093] When the expandable assembly 200 completely blocks the venous ostium 510, the temperatures of the first through sixth temperature measuring elements MT1, MT6, and MT7 rise steadily after the warm liquid is introduced for a predetermined period of time. At this point, the expandable assembly 200 effectively blocks the venous ostium 510. If the expandable assembly 200 does not completely block the venous ostium 510 at the first temperature measuring element MT1, blood will flow out from the gap between the expandable assembly 200 and the venous ostium 510 at the first temperature measuring element MT1. The temperature detected by the first temperature measuring element MT1 will rise rapidly, while the temperatures between the second and third temperature measuring elements MT2 and MT3 will rise steadily. This indicates that the expandable assembly 200 has not effectively blocked the venous ostium 510, leaking at the first temperature measuring element but effectively blocking it at the remaining temperature measuring elements. In this case, the position of the expandable assembly 200 can be adjusted to ensure that the expandable assembly 200 effectively blocks the venous ostium 510 at all temperature measuring elements. The principles of leakage in the second and third temperature measuring elements MT2 and MT3 are essentially the same and will not be further elaborated here.

[0094] When the expandable assembly 200 fails to completely seal 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 seal the orifice 510, leakage occurs between the first temperature-measuring element MT1 and the second temperature-measuring element MT2. This indicates that the fourth temperature-measuring element MT4 has failed to effectively seal the venous orifice 510. When the remaining locations are effectively sealed, the position of the expandable assembly 200 is adjusted to ensure that the expandable assembly 200 effectively seals all temperature-measuring elements. The principle of leakage in the fifth and sixth temperature-measuring elements MT5 and MT6 is essentially the same and will not be further described here.

[0095] Referring to Figures 3 and 8, Figure 8 shows a temperature curve showing the temperature of the temperature measuring assembly 300 recovering after the cryoablation catheter 10 shown in Figure 2 has effectively blocked the vein. When the expandable assembly 200 completely blocks the venous ostium 510, blood in the vein 50 cannot flow to the atrium. After a certain amount of warm liquid is injected into the main tube 120 through the first delivery channel, the warm liquid flows through the distal end of the first delivery channel into the blood in the vein 50. At this point, the warm liquid cannot flow to the atrium. As the warm liquid gradually mixes with the blood, the temperature in the vein 50 gradually decreases from the initial blood temperature. At this point, the first, second, and third temperature measuring elements MT1, MT2, and MT3 record the temperature changes. The recorded data is calculated and judged by the controller, ultimately displaying the blockage status of the expandable assembly 200 on the display screen. Generally, the judgment logic is as follows: starting from the temperature measured at each temperature measuring point 321 on the balloon surface, the rate or amplitude of temperature recovery over a certain period of time is calculated to determine the blockage status of the vein 50. In this case of complete blockage, the blood in vein 50 cannot flow into the left atrium. Therefore, after a certain amount of normal saline is injected, the temperature of the venous opening 510 drops to the lowest point, and then it will remain for a period of time or slowly recover due to the factor of body temperature, and the recovery rate is small within a certain period of time. Figure 8 is a surface temperature change curve when the balloon is completely blocked. The temperature of each point on the surface recovers slowly within 20s. The falling temperature of the blood is measured by the temperature measuring component 300. When the blood drops to the lowest temperature, the temperature of the blood will remain for a period of time or slowly recover due to the factor of body temperature, and the recovery rate is small within a certain period of time. That is, after the expandable component 200 completely blocks the venous opening 510, the temperature measuring component 300 begins to recover steadily after detecting the lowest temperature, indicating that the expandable component 200 effectively blocks the venous opening 510, as shown in Figures 3 and 8. After 20s, the temperature of each temperature measuring component recovers slowly.

[0096] Referring to Figures 4 and 9, Figure 9 shows a temperature curve of the temperature measuring assembly 300 recovering after the cryoablation catheter 10 shown in Figure 2 fails to effectively occlude the vein 510. When the expandable assembly 200 fails to completely occlude the venous ostium 510, a gap exists between the venous ostium 510 and the expandable assembly 200, allowing blood in the vein 50 to flow through the gap into the atrium. After the expandable assembly 200 is inflated and in its expanded configuration, a certain amount of warm liquid is injected into the main tube 120 through the first delivery channel. The warm liquid flows through the distal end of the first delivery channel into the blood in the vein 50. After gradually mixing with the blood, some of the warm liquid flows into the atrium through the gap between the expandable assembly 200 and the venous ostium 510. Under the influence of the blood flow, the temperature of the venous ostium 510 drops to its lowest point before recovering at a relatively fast rate, with a significant increase within a certain period of time, indicating that the expandable assembly 200 fails to completely occlude the venous ostium 510. As shown in Figures 4 and 9 , the temperature detected by the first temperature-measuring element MT1 rises rapidly, while the temperature at the second and third temperature-measuring elements MT2 and MT3 rises more slowly. Based on the temperature curves in Figure 9 , it can be determined that a leak has occurred at the first temperature-measuring element MT1. Based on the marking point 330 on the first temperature-measuring element MT1 and its position within the vein 50, the operator can ensure complete occlusion of the vein ostium 510 by adjusting the position of the expandable assembly 200.

[0097] The cryoablation catheter 10 of the present application delivers gas through the airflow channel 130 of the main tube 120 to expand the expandable component 200, placing the expandable component 200 in an expanded configuration and sealing the venous ostium 510. During the cryoablation process, the coordination of the airflow channel, the second delivery channel, and the expandable component 200 enables cryoablation. Furthermore, before ablation, the cryoablation catheter 10 delivers a harmless, mild liquid into the vein 50 through the first delivery channel. The temperature measurement component 300 on the expandable component 200 can be used to measure temperature changes to determine the current occlusion status and whether there is a leak between the expandable component 200 and the venous ostium 510. This can also reduce the use of contrast agents and X-rays, preventing harm to the health of doctors and patients. Furthermore, the temperature measurement component 300 can determine the specific location of the leak, thereby helping the operator quickly rotate and / or move the expandable component 200 to adjust its direction and position for effective occlusion, facilitating subsequent ablation treatment and ensuring therapeutic efficacy.

[0098] 1 to 5 , the present application further provides a control method for a cryoablation catheter 10 , which is applied to the cryoablation catheter 10 in any of the above embodiments. The control method includes the following steps:

[0099] Insert the distal end of the cryoablation catheter 10 into the venous ostium 510;

[0100] delivering gas to the expandable component 200 to expand the expandable component 200 to occlude the venous ostium 510;

[0101] A warm liquid is injected into the vein 50 and mixed with the blood in the vein 50;

[0102] The temperature measuring component 300 obtains the temperature of the venous opening 510 and feeds it back to the controller of the refrigeration equipment 60. The controller determines whether the expandable component 200 effectively blocks the venous opening 510 based on the temperature recovery rate of the venous opening 510.

[0103] 1 to 5 , when the cryoablation catheter 10 is used, the distal end of the cryoablation catheter 10 is inserted into a blood vessel, and the slender body 100 is pushed, so that the expandable component 200 moves to the venous ostium 510. Subsequently, gas is delivered from the airflow channel 130 to the expandable component 200, so that the expandable component 200 switches from a contracted configuration to an expanded configuration. At this time, the expandable component 200 is able to block the venous ostium 510. After the expandable component 200 blocks the venous ostium 510, it is necessary to determine the effectiveness of the blockage of the venous ostium 510. A warm liquid is delivered from the first delivery channel into the vein 50. The temperature measuring component 300 detects the blood temperature at the venous ostium 510 and feeds back to the controller to determine whether the expandable component 200 effectively blocks the venous ostium 510.

[0104] When determining whether the blockage is effective, the controller determines that if the temperature detected by the temperature measuring component 300 steadily rises, it indicates that the expandable component 200 can effectively block the venous ostium 510. If the temperature detected by the temperature measuring component 300 rises rapidly, it indicates that the expandable component 200 has not effectively blocked the venous ostium 510. In this case, there is a leak in at least one location of the expandable component 200, and the position of the cryoablation catheter 10 needs to be adjusted until the expandable component 200 effectively blocks the venous ostium 510. At the same time, the mild liquid does not damage the blood vessels, can effectively prevent patients from being intolerant to contrast agents, reduce X-ray exposure, and avoid harm to the patient and the operator, as shown in Figures 4 and 5. Once the blockage is complete, the cryoablation catheter 10 performs cryoablation on the lesion near the venous ostium 510 to achieve the purpose of treatment.

[0105] In one embodiment, the controller determines whether the expandable component 200 effectively blocks the venous opening 510 based on the temperature change of the venous opening 510, including the following steps:

[0106] After the warm liquid is injected into the vein 50, the temperature measuring component 300 obtains the first temperature of the mixture of the warm liquid and blood at the vein opening 510;

[0107] After a preset time, the temperature measuring component 300 obtains the second temperature of the venous opening 510 and feeds it back to the controller. The second temperature is greater than the first temperature. The controller determines whether the expandable component 200 effectively blocks the venous opening 510 based on the recovery rate from the first temperature to the second temperature.

[0108] The blood has an initial temperature in the vein 50. After the expandable component 200 blocks the venous opening 510, the temperature measuring component 300 obtains the initial temperature of the venous opening 510 and feeds it back to the controller. A warm liquid is introduced into the vein 50, the warm liquid mixes with the blood, and the temperature measuring component 300 detects that the temperature of the blood in the vein 50 drops to a first temperature, which is lower than the initial temperature. The first temperature is the lowest temperature after the warm liquid and the 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 this temperature is recorded as the second temperature, which is higher than the first temperature. At this time, the controller can determine whether the blockage is effective based on the rate of recovery from the first temperature to the second temperature. When the controller determines that the second temperature rises steadily, the expandable component 200 effectively blocks the venous opening 510. When the controller determines that the second temperature rises rapidly, the expandable component 200 does not effectively block the venous opening 510.

[0109] In one embodiment, the controller determines whether the expandable component 200 effectively blocks the venous ostium 510 based on the recovery rate of the second temperature, and further includes the following steps:

[0110] When the controller determines that the second temperature is at the first recovery rate, the controller determines that the expandable component 200 effectively blocks the venous ostium 510 ;

[0111] When the controller determines that the second temperature is at the second recovery rate, the controller determines that the expandable component 200 has not effectively blocked the venous ostium 510 ;

[0112] The first recovery rate is smaller than the second recovery rate.

[0113] When the controller determines that the second temperature is rising at the first rising rate, the second temperature is rising steadily, and the expandable component 200 effectively blocks the venous ostium 510. When the controller determines that the second temperature is rising at the second rising rate, the second temperature is rising rapidly, and the expandable component 200 does not effectively block the venous ostium 510.

[0114] In one embodiment, there are multiple temperature measuring components 300, which are arranged on the expandable component 200 and are distributed along the circumference to contact the inner wall of the venous opening 510. The control method further includes the following steps:

[0115] Each temperature measuring component 300 obtains the temperature at the corresponding position of the vein opening 510;

[0116] After the warm liquid is injected, if the temperature measured by each temperature measuring component 300 rises steadily, the expandable component 200 effectively blocks the vein opening 510;

[0117] If the temperature obtained by at least one temperature measuring component 300 rises rapidly, the expandable component 200 has a leak at the corresponding temperature measuring component 300;

[0118] The cryoablation catheter 10 is rotated until the temperature measured by each temperature measuring component 300 rises steadily.

[0119] After the expandable component 200 blocks the venous opening 510, multiple temperature measuring components 300 are distributed at different positions of the venous opening 510. After the introduction of warm liquid, each temperature measuring component 300 can respectively obtain the temperature at the corresponding position of the venous opening 510. If the temperature obtained by each temperature measuring component 300 rises steadily, the controller determines that the expandable component 200 has effectively blocked the venous opening 510. If the temperature obtained by at least one temperature measuring component 300 rises rapidly, it means that there is a gap between the expandable component 200 and the venous opening 510 at the position corresponding to the temperature measuring component 300, 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 temperature obtained by each temperature measuring component 300 rises steadily to effectively block the venous opening 510.

[0120] Referring to FIG1 , the present application also provides a cryoablation system, comprising a cryoablation device 60, a display control device 70, and a cryoablation catheter 10 having any of the above-described technical features. The display control device 70 is connected to the cryoablation device 60. The proximal end of the control handle 400 of the cryoablation catheter 10 is connected to the cryoablation device 60, and the distal end extends into the ostium 510 of the vein to block the ostium 510. The cryoablation system of the present application utilizes the cryoablation catheter 10 of the above-described embodiment. The cryoablation catheter 10 delivers a mild liquid to the vein 50 and uses temperature measurement to determine whether the blockage is effective, thereby reducing the use of contrast agents and X-rays. When a leak occurs, the specific location of the leak can be easily determined, allowing for effective blockage and ensuring therapeutic efficacy. The cryoablation device 60 includes a controller, and the display control device 70 includes a display screen. 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 blockage status on the display screen.

[0121] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0122] The above-described embodiments merely represent several implementation methods of the present application. While the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that a person of ordinary skill in the art may make various modifications and improvements without departing from the spirit of the present application, and these modifications and improvements fall within the scope of protection of the present application. Therefore, the scope of protection of the present patent application shall be determined by the appended claims.

Claims

1. A cryoablation catheter, characterized in that, It includes a slender body, an inflatable assembly, and a temperature measuring assembly. The inflatable assembly is arranged at the distal end of the slender body and has an inflated configuration and a contracted configuration. When the inflatable assembly 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 assembly 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 assembly. 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 assembly is arranged on the inflatable assembly and can detect the temperature of the venous orifice to judge the effectiveness of the blockage by the inflatable assembly.

2. The cryoablation catheter according to claim 1, wherein The inflatable assembly includes a first inflatable element and a second inflatable element. The first inflatable element covers the second inflatable element. The inner cavity of the second inflatable element communicates with the air flow channel. The temperature measuring assembly 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 assemblies is multiple, and the multiple temperature measuring assemblies are arranged on the inflatable assembly. There is a spacing between adjacent temperature measuring assemblies, or the multiple temperature measuring assemblies cover the inflatable assembly.

4. The cryoablation catheter according to any one of claims 1 to 3, characterized in that, The temperature measuring assembly includes a temperature measuring element and a fixing component. The fixing component fixes the temperature measuring element on the inflatable assembly, and the temperature measuring element and the fixing component are stretched as the inflatable assembly 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 for marking 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, and 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 a marking point. At least one fixing component without a marking point is arranged between adjacent fixing components with a marking point.

10. The cryoablation catheter according to claim 6, wherein, At least one of the number, shape, and 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 assembly to make the inflatable assembly expand to block the venous orifice. Inject warm liquid into the vein and mix it with the blood in the vein. The temperature measuring component obtains the temperature of the venous orifice and feeds it back to the controller of the cryogenic device. The controller determines whether the expandable component effectively blocks the venous orifice according to the temperature rise rate of the venous orifice.

12. The control method according to claim 11, characterized in that, 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: After injecting warm liquid into the vein, the temperature measuring component obtains the first temperature after the warm liquid and blood are mixed at the venous orifice. After a preset time, the temperature measuring component obtains the second temperature of the venous orifice and feeds it back to the controller. The second temperature is greater than the first temperature. The controller determines whether the expandable component effectively blocks the venous orifice according to the rise rate from the first temperature to the second temperature.

13. The control method according to claim 12, wherein The controller determines whether the expandable component effectively blocks 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 blocks 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 block the venous orifice. Wherein, the first rise rate is less than the second rise rate.

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

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