Cryoablation catheter with supporting device and system

Abstract

The utility model relates to a cryoablation catheter with a supporting device, which comprises a sheath tube, an air inlet tube, an air return tube, a guide wire cavity tube, a bag body, the supporting device and a handle, the far end of the sheath tube is fixedly connected with the near end of the bag body, the near end of the sheath tube is fixedly connected with the handle, the far end of the bag body is fixedly connected with the far end of the guide wire cavity tube, and the bag body is fixedly connected with the handle. The supporting device is composed of an inner supporting piece and an outer supporting piece, the inner supporting piece is arranged in the bag body, the outer supporting piece is arranged outside the bag body, the supporting device is of a self-expanding structure, when the supporting device is converted from a compressed state to an expanded state, the inner supporting piece supports the inner wall of the bag body, and the outer supporting piece supports the outer wall of the bag body. The capsule body is tightly attached to a target area, the outer supporting piece is supported on the inner wall of a blood vessel, and a blood flow channel is established between the outer side of the capsule body and the inner wall of the blood vessel.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a cryoablation catheter and system with a support device. Background Technology

[0002] Balloon catheter ablation is a minimally invasive interventional treatment that uses cryo-energy for ablation. Compared to radiofrequency ablation, cryoballoon technology is easier for doctors to operate, significantly shortens the procedure time, and reduces patient discomfort. Currently, the balloons widely used in clinical practice are mostly for pulmonary vein potential isolation in atrial fibrillation; therefore, the target vessel for ablation is only the pulmonary vein, and it cannot be widely applied to other blood vessels and natural cavities. In the vascular field, because conventional cryoballoon catheters require vascular occlusion, blood flow must be interrupted during ablation. Therefore, its application in the pulmonary artery, renal artery, and branch arteries can easily cause damage to normal tissues, leading to complications. In the natural cavities and skin, the freezing range of conventional cryoballoon catheters is uncontrollable and lacks selectivity, causing damage to normal tissues. Furthermore, the issue of ablation adhesion during the ablation process is a major challenge. Summary of the Invention

[0003] To address the shortcomings of existing technologies, this application provides a cryoablation catheter and system with a support device.

[0004] The objective of this application is achieved through the following technical solution:

[0005] A cryoablation catheter with a support device is disclosed. The catheter includes a sheath, an inlet tube, a return tube, a guidewire lumen, a balloon, a support device, and a handle. The inlet tube, return tube, and guidewire lumen are all located within the sheath. The distal ends of the inlet tube and the return tube extend beyond the distal end of the sheath and are disposed within the balloon, communicating fluidly with it. The distal end of the sheath is fixedly connected to the proximal end of the balloon, and the proximal end of the sheath is fixedly connected to the handle. The distal end of the balloon is fixedly connected to the distal end of the guidewire lumen. The support device consists of an inner support member and an outer support member. The inner support member is disposed within the balloon, and the outer support member is disposed outside the balloon. The support device is a self-expanding structure. When the support device changes from a compressed state to an expanded state, the inner support member supports the inner wall of the balloon, causing the balloon to fit tightly against the target area. The outer support member supports the inner wall of the blood vessel, establishing a blood flow channel between the outer side of the balloon and the inner wall of the blood vessel.

[0006] In an optional embodiment, a telescopic tube is sleeved on the distal portion of the guidewire lumen, the telescopic tube being located within the bladder. The proximal end of the telescopic tube is sealed to the proximal ends of the inner support, the outer support, the bladder, the air inlet tube, and the air return tube. The distal end of the telescopic tube is sealed to the guidewire lumen. The guidewire lumen is axially movable relative to the sheath, allowing the telescopic tube to be stretched or compressed, thereby controlling the shape and circumferential dimension changes of the inner and outer support.

[0007] In a preferred embodiment, a proximal support ring is provided at the proximal end of the support device, and a distal support ring is provided at the distal end of the support device. The proximal support ring and the distal support ring are fixedly connected to the support device by means of laser welding, soldering, hot melting or adhesive.

[0008] In an optional embodiment, the handle is provided with an adjustment mechanism, which is fixedly connected to the proximal end of the guidewire lumen. The adjustment mechanism controls the shape and circumferential dimension changes of the inner support and the outer support by controlling the axial movement of the guidewire lumen.

[0009] In an alternative embodiment, the capsule is blow-molded from one lumen of a dual-lumen tube.

[0010] In one optional embodiment, the support device is a split structure, the telescopic tube consists of an inner telescopic tube and an outer telescopic tube. The inner telescopic tube is sleeved on the distal portion of the guidewire lumen and located within the capsule. The distal end of the inner telescopic tube is sealed to the distal ends of the guidewire lumen and the inner support member. The proximal end of the inner telescopic tube is sealed to the inlet tube, the return tube, the proximal end of the capsule, and the proximal end of the inner support member. A liner is provided along the inner lumen of the sheath, the distal end of which extends beyond the distal end of the sheath. The outer telescopic tube is sleeved on... The portion of the liner extending out of the sheath is provided within another lumen of the double-lumen tube. The distal end of the outer telescopic tube is fixedly connected to the distal end of the liner, the distal end of the outer support, and the distal end of the other lumen of the double-lumen tube. The proximal end of the outer telescopic tube is sealed to the proximal end of the other lumen of the double-lumen tube and the proximal end of the outer support. The proximal end of the liner is fixedly connected to an adjustment mechanism on the handle. The adjustment mechanism controls the axial movement of the guidewire lumen and the liner, respectively.

[0011] In one optional embodiment, the support device is a split structure, the telescopic tube consists of an inner telescopic tube and an outer telescopic tube, the sheath is a double-lumen tube, the air inlet tube, the air return tube, and the guidewire lumen are disposed in the first lumen of the sheath, and a liner is disposed in the second lumen of the sheath. The inner telescopic tube is sleeved on the distal portion of the guidewire lumen and located within the bladder. The distal end of the inner telescopic tube is sealed to the distal ends of the guidewire lumen and the inner support member, and the proximal end of the inner telescopic tube is connected to the air inlet tube, the air return tube, and the bladder. The proximal end of the body and the proximal end of the inner support are sealed together. The distal end of the liner extends from the second cavity of the sheath and is located outside the body. The outer telescopic tube is sleeved on the portion of the liner that extends out of the sheath. The distal end of the outer telescopic tube is fixedly connected to the distal ends of the liner and the outer support. The proximal end of the outer telescopic tube is sealed together with the proximal end of the outer support and the second cavity. The proximal end of the liner is fixedly connected to the adjustment mechanism on the handle. The adjustment mechanism controls the axial movement of the guidewire lumen and the liner, respectively.

[0012] In one optional embodiment, a proximal inner support ring is provided at the proximal end of the inner support member, a distal inner support ring is provided at the distal end of the inner support member, a proximal outer support ring is provided at the proximal end of the outer support member, and a distal outer support ring is provided at the distal end of the outer support member. The proximal inner support ring and the distal inner support ring are respectively fixedly connected to both ends of the inner support member, and the proximal outer support ring and the distal outer support ring are respectively fixedly connected to both ends of the outer support member. The proximal inner support ring and the distal inner support ring are sleeved on the inner telescopic tube, and the proximal outer support ring and the distal outer support ring are sleeved on the outer telescopic tube.

[0013] In one optional embodiment, the capsule is asymmetrical in the axial direction with the central axis of the guidewire lumen as the axis of symmetry. Preferably, the capsule is hemispherical.

[0014] In one alternative embodiment, the telescopic tube is a corrugated tube, or the telescopic tube is a threaded tube with helical grooves, or the telescopic tube is a spring coil.

[0015] Another embodiment of this application provides a cryoablation system, including a cryoablation device and the aforementioned cryoablation catheter. The cryoablation catheter is connected to the cryoablation device via a connector and is used to deliver the refrigerant in the cryoablation device to the capsule to perform cryoablation.

[0016] Compared with the prior art, the advantages of the embodiments of this application are as follows:

[0017] 1. In the embodiments of this application, the support device consists of two parts: an internal support and an external support. The internal support is located inside the capsule, which helps the capsule to directly adhere to the target ablation area and improves the ablation efficiency. The external support is located outside the capsule and supports the blood vessel wall, establishing a blood flow channel between the capsule and the inner wall of the blood vessel. This structure not only improves the stability of the cryoablation unit positioning but also facilitates blood flow, solving the problems of blood flow interruption and the capsule not fully adhering to the target tissue when using a balloon for cryoablation in the prior art.

[0018] 2. In the embodiments of this application, a telescopic tube is provided outside the guide wire cavity. The telescopic tube can move axially relative to the guide wire cavity, thereby causing the support member fixedly connected to the distal end of the telescopic tube to expand or contract.

[0019] 3. In the embodiments of this application, the telescopic tube consists of an inner telescopic tube and an outer telescopic tube. The inner telescopic tube is sleeved outside the guidewire lumen, and the outer telescopic tube is sleeved outside the liner. The inner telescopic tube can adjust the size of the inner support, and the outer telescopic tube is used to adjust the size of the outer support. The separate adjustment of the size of the inner support and the outer support expands the application range of the cryoablation catheter of this application, and it can be used for blood vessels of various sizes and structures as well as natural channels. Attached Figure Description

[0020] Figure 1 This is a schematic diagram of the overall structure of the cryoablation catheter with support device of this application.

[0021] Figure 2 for Figure 1 An enlarged schematic diagram of the distal portion of the cryoablation catheter shown.

[0022] Figure 3 This is a schematic diagram of one embodiment of the telescopic tube in a cryoablation catheter.

[0023] Figure 4A and Figure 4B This is a schematic diagram of various embodiments of the capsule of a cryoablation catheter.

[0024] Figure 5 This is a schematic diagram showing the cryoablation catheter with support device of this application in the state of the blood vessel.

[0025] Figure 6 for Figure 1 A right-hand view of the distal portion of the cryoablation catheter.

[0026] Figure 7A and Figure 7B This is a schematic diagram of the combined structure of the inner and outer support components of the cryoablation catheter in Example 1.

[0027] Figure 8 This is a schematic diagram of a cryoablation system.

[0028] Figure 9 This is a schematic diagram of the capsule structure of the cryoablation catheter in Example 2.

[0029] Figure 10A and Figure 10B This is a schematic diagram of the split-type support device for the cryoablation catheter in Example 2.

[0030] Figure 11 This is a schematic diagram of the distal portion of the cryoablation catheter in Example 2.

[0031] Figure 12 This is a schematic diagram of another embodiment of the distal portion of the cryoablation catheter in Example 3.

[0032] Figure label:

[0033] 100 - Cryoablation catheter; 200 - Cryoablation equipment;

[0034] 1-Sheath; 2-Inlet tube; 3-Return tube; 4-Guidewire lumen; 5-Cuff body; 6-Support device; 7-Handle; 8-Telescopic tube; 9-Connector; 10-Blood vessel; 11-Blood flow channel; 12-Liner; 20-Outer sheath; 61-Inner support; 62-Outer support; 63-Proximal support ring; 64-Distal support ring; 65-Proximal inner support ring; 66-Distal inner support ring; 67-Proximal outer support ring; 68-Distal outer support ring; 71-Bending mechanism; 72-Adjustment mechanism; 73-Flexible tube; 81-Inner telescopic tube; 82-Outer telescopic tube; 201-Human-machine interface module; 202-Control module; 203-Pneumatic circuit module. Detailed Implementation

[0035] To make the above-mentioned objectives, features, and advantages of this application more apparent and understandable, the specific embodiments of this application are described in detail below with reference to the accompanying drawings. Many specific details are set forth in the following description to provide a thorough understanding of this application. However, this application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar modifications without departing from the spirit of this application. Therefore, this application is not limited to the specific embodiments disclosed below.

[0036] In the description of this application, it should be understood that if terms such as "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", "clockwise", "counterclockwise", "axial", "radial", "circumferential" appear, these terms indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation, and therefore should not be construed as a limitation of this application.

[0037] Furthermore, where the terms "first" and "second" appear, these terms are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined with "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this application, where the term "multiple" appears, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0038] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "joining," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application based on the specific circumstances.

[0039] In this application, unless otherwise expressly specified and limited, the use of descriptions such as "above" or "below" the second feature indicates that the first and second features are in direct contact or indirect contact via an intermediate medium. Furthermore, "above," "on top of," and "over" the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. Similarly, "below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0040] It should be noted that if an element is referred to as being "fixed to" or "set on" another element, it can be directly on the other element or there may be an intervening 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 intervening element. If so, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and similar expressions used in this application are for illustrative purposes only and do not represent the only possible implementation.

[0041] The proximal end, as described in this application, refers to the end closer to the surgical operator, while the distal end refers to the end farther away from the surgical operator.

[0042] The technical solutions provided by the embodiments of this application are described below with reference to the accompanying drawings.

[0043] Example 1

[0044] like Figure 1 As shown, this application provides a cryoablation catheter 100 with a support device, including a sheath 1, an inlet tube 2, a return tube 3, a guidewire lumen 4, a capsule 5, a support device 6, and a handle 7. The inlet tube 2, the return tube 3, and the guidewire lumen 4 are all located within the sheath 1. The distal ends of the inlet tube 2 and the return tube 3 extend beyond the distal end of the sheath 1 and are disposed within the capsule 5 and in fluid communication with the capsule 5. The distal end of the sheath 1 is fixedly connected to the proximal end of the capsule 5, and the proximal end of the sheath 1 is fixedly connected to the handle 7. The inlet tube 2 and the return tube 3 are connected to a connector 9. The distal end of the capsule 5 is fixedly connected to the distal end of the guidewire lumen 4. The characteristic feature is that, as... Figure 2 As shown, the support device 6 consists of an inner support member 61 and an outer support member 62. The inner support member 61 is disposed inside the bladder 5, and the outer support member 62 is disposed outside the bladder 5. The support device 6 is a self-expanding structure. Figure 5 As shown, during operation, the cryoablation catheter of this application is provided with an outer sheath 20. When the support device 6 is released from the distal end of the outer sheath 20 and changes from a compressed state to an expanded state, the inner support 61 supports the inner wall of the capsule 5, so that the capsule 5 is closely attached to the target area of ​​the blood vessel. The outer support 62 is supported on the inner wall of the blood vessel 10, establishing a blood flow channel 11 between the outer side of the capsule 5 and the inner wall of the blood vessel 10. The inner support 61 of this application is located inside the capsule 5, which helps the capsule 5 to directly adhere to the target ablation area and improves the ablation efficiency. The outer support 62 is located outside the capsule 5 and supports the blood vessel wall. This structure not only improves the stability of the cryoablation unit positioning, but also facilitates blood flow, solving the problems of blood flow interruption and the capsule not being fully attached to the target tissue when using a balloon for cryoablation in the prior art.

[0045] like Figure 2 As shown, a telescopic tube 8 is sleeved on the distal portion of the guidewire lumen 4. The telescopic tube 8 is located inside the bladder body 5. The proximal end of the telescopic tube 8 is sealed to the proximal ends of the inner support member 61, the outer support member 62, the bladder body, the air inlet tube 2, and the air return tube 3. The distal end of the telescopic tube 8 is sealed to the guidewire lumen 4. The sealing connection methods include, but are not limited to, heat fusion, adhesive bonding, and laser welding. The guidewire lumen 4 can move axially relative to the sheath tube 1, allowing the telescopic tube 8 to be stretched or compressed, thereby controlling the shape and circumferential dimension changes of the inner support member 61 and the outer support member 62. When the guidewire lumen 4 moves toward the distal end, the telescopic tube 8 is in a stretched state, and the axial dimensions of the inner support 61 and the outer support 62 increase while the circumferential dimensions decrease; when the guidewire lumen 4 moves toward the proximal end, the telescopic tube 8 is in a compressed state, and the axial dimensions of the inner support 61 and the outer support 62 decrease while the circumferential dimensions increase.

[0046] like Figure 1 As shown, the sheath 1 is an adjustable bend tube, and its inner cavity is a vacuum-insulated chamber. An adjustment mechanism 71 is provided on the handle 7, which controls the bending shape of the sheath 1 via a pull wire (not shown in the figure). The pull wire is fixed inside the wall of the sheath 1, with its distal end connected to the distal end of the sheath 1 and its proximal end connected to the adjustment mechanism 71. By setting the adjustment mechanism 71, the curvature of the sheath 1 can be adjusted so that the capsule 5 can better conform to the target tissue. Furthermore, two pull wires are provided, symmetrically arranged on both sides of the sheath 1. This allows for bidirectional bending of the cryoablation catheter, making it more flexible to use. The adjustable bend tube is preferably made of PTFE, Pebax, or 304 stainless steel. The handle 7 is also provided with an adjustment mechanism 72, which is fixedly connected to the proximal end of the guidewire lumen 4. The adjustment mechanism 72 controls the shape and circumferential dimensions of the inner support member 61 and the outer support member 62 by controlling the axial movement of the guidewire lumen 4, thereby controlling the shape and size of the capsule 5. The adjustment mechanism 72 can be a structure that combines a slider and a groove, or other structures in the prior art that can control the axial movement of the guidewire lumen 4, which will not be described in detail here.

[0047] In one embodiment, a temperature sensor is provided on the inner support 61. The connector 9 includes an inlet connector, a return connector, a vacuum connector, and a temperature sensor connector. The inlet connector is connected to the inlet pipe 2, the return connector is connected to the return pipe 3, the vacuum connector is connected to the vacuum insulation cavity inside the sheath 1, and the temperature sensor connector is connected to a temperature sensor. In one embodiment, the connector 9 is connected to the handle 7 via a flexible tube 73. The connector 9 is connected to a cryoablation device, which delivers refrigerant to the inlet pipe 2 via the connector 9. The refrigerant is then delivered to the capsule 5 via the inlet pipe 2 to achieve cryoablation of the target area. The refrigerant is then returned to the cryoablation device via the return pipe 3, or discharged from the return connector via the return pipe 3. The refrigerant includes, but is not limited to, N2, N2O, and liquid nitrogen. In one embodiment, several jet holes are provided in the portion of the inlet pipe 2 located inside the capsule 5. The refrigerant is injected into the capsule 5 through these jet holes. The jet holes allow for more uniform injection of the refrigerant into the capsule, improving freezing efficiency.

[0048] In one implementation, such as Figure 3 As shown, the telescopic tube 8 is a corrugated tube that can be both stretched and compressed. In another embodiment, the telescopic tube 8 is a threaded tube with helical grooves. In yet another embodiment, the telescopic tube 8 is a spring coil.

[0049] like Figure 5 As shown, when the capsule 5 and the support device 6 are fully expanded, the maximum diameter of the capsule 5 is smaller than the maximum diameter of the support device 6. The capsule 5 can adopt a shape commonly used in the prior art, or it can adopt other shapes, such as... Figure 6 As shown, with the central axis of the guidewire lumen 4 as the axis of symmetry, the capsule 5 has an asymmetrical structure in the axial direction. In one embodiment, as shown... Figure 4A and Figure 4B As shown, the capsule 5 is hemispherical. The capsule 5 can be blow-molded from a single-lumen tube. The capsule 5 is a compliant balloon or a semi-compliant balloon. In another embodiment, the capsule 5 can be a single-layer balloon or a double-layer balloon.

[0050] As shown in Figure 7, the support device 6 consists of an inner support member 61 and an outer support member 62. A proximal support ring 63 is provided at the proximal end of the support device 6, and a distal support ring 64 is provided at the distal end. The proximal support ring 63 and the distal support ring 64 are fixedly connected to the support device 6 by laser welding, soldering, hot melting, or adhesive bonding. When the support device 6 is connected to the capsule 5, the inner support member 61 can be inserted into the blow-molded capsule 5 first, the inner support member 61 can be straightened, and then the proximal end of the inner support member 61 can be connected to the proximal support ring 63, and the distal end of the inner support member 61 can be connected to the distal support ring 64. The two ends of the outer support member 62 are fixedly connected to the proximal support ring 63 and the distal support ring 64, respectively. The proximal support ring 63 and the distal support ring 64 are sleeved on the telescopic tube 8. The proximal support ring 63 is sealed to the proximal ends of the air inlet pipe 2, the air return pipe 3, the telescopic pipe 8, and the proximal end of the bladder body 5. The distal support ring 64 is sealed to the distal end of the telescopic pipe 8. Both the inner support member 61 and the outer support member 62 can be made of multiple sheet-like, filament-like, or rod-like shape memory materials. In one embodiment, the proximal end of the outer support member 62 is fixedly connected to the proximal support ring 63, and the distal end of the outer support member 62 is fixedly connected to the distal support ring 64. Connection methods include, but are not limited to, laser welding, soldering, hot melting, and adhesive bonding.

[0051] Another embodiment of this application provides a cryoablation system, referring to FIG7, including a cryoablation device 200 and the aforementioned cryoablation catheter 100. The cryoablation catheter 100 is connected to the cryoablation device 200 via a connector 9 for delivering the refrigerant in the cryoablation device 200 to the capsule 5 via the connector 9 and performing cryoablation.

[0052] Specifically, in this embodiment, the cryoablation device 200 includes a human-machine interface module 201, a control module 202, and a gas path module 203. The human-machine interface module 201 is electrically connected to the control module 202, and the control module 202 is electrically connected to the gas path module 203. The gas path module 203 can be connected to the handle 7 of the cryoablation conduit 100 via a connector 9. The gas path module 203 of the cryoablation device is connected to the inlet and outlet connectors on the handle 7 via connectors 9, respectively, for supplying or recovering refrigerant to the cryoablation conduit 100. The gas path module 203 of the cryoablation device is connected to the vacuum connector on connector 9, so that the inner cavity of the sheath 1 is in a vacuum state to prevent the loss of cold energy of the refrigerant during the delivery process and the frost phenomenon of the sheath 1. Thermocouple connectors on connector 9 are connected to the control module 202 to monitor the temperature inside the capsule 5. The above is an exemplary description of a cryoablation system. In actual applications, the cryoablation device 200 can also adopt other existing technical means, which will not be described in detail here.

[0053] During operation, the following steps can be used to complete the ablation process of the cryoablation system of this application.

[0054] S1: Connect the connector of the cryoablation catheter to the cryoablation device and start the cryoablation device.

[0055] S2: Insert the cryoablation catheter into the blood vessel to be ablated within the patient's body.

[0056] S3: By controlling the bending mechanism at the handle, the distal part of the cryoablation catheter is delivered to the ablation position.

[0057] S4: Extend the distal portion of the cryoablation catheter out of the outer sheath. Adjust the handle using the adjustment mechanism to open the support mechanism at the ablation position. Based on the required ablation area, adjust the guidewire lumen axially using the handle, simultaneously controlling the axial and circumferential dimensions of the support mechanism to ensure the inner support mechanism is in contact with the ablated tissue for pre-positioning. As the guidewire lumen moves distally, the telescopic tube is stretched, increasing the axial dimension and decreasing the circumferential dimension of the support mechanism. As the guidewire lumen moves proximally, the telescopic tube is compressed, decreasing the axial dimension and increasing the circumferential dimension of the support mechanism.

[0058] S5: The refrigerant in the cryogenic ablation equipment enters the inlet pipe through the inlet connector, and is then sprayed out through the nozzle located at the far end of the inlet pipe, entering the bladder.

[0059] S6: After the refrigerant (which can be liquid nitrogen, liquid nitrous oxide, or other cryogenic media) enters the capsule, it inflates the capsule and performs cryoablation on the target tissue. While the capsule is inflated, blood flow remains normal through the channel between the capsule and the external support.

[0060] S7: A temperature sensor located on the internal support inside the cyst provides real-time temperature feedback. The cryoablation device automatically adjusts based on the feedback temperature to avoid complications caused by excessively low temperatures.

[0061] S8: During the ablation process, the refrigerant inside the capsule completes heat exchange and then enters the recovery device of the cryogenic ablation equipment through the return gas pipe and return gas connector, thus forming a cold source loop.

[0062] S9: Ablation ends. The adjustment mechanism unit at the control handle causes the support device and capsule to contract and retract.

[0063] Example 2

[0064] The structure of the cryoablation catheter with support device described in this embodiment is basically the same as that in Embodiment 1, except that:

[0065] like Figure 10A and Figure 10B As shown, the support device 6 is a split structure. The inner support member 61 and the outer support member 62 of the support device 6 are manufactured separately. The inner support member 61 is disposed inside the bladder 5, and the outer support member 62 is disposed outside the bladder 5. A proximal inner support ring 65 is provided at the proximal end of the inner support member 61, and a distal inner support ring 66 is provided at the distal end of the inner support member 61. A proximal outer support ring 67 is provided at the proximal end of the outer support member 62, and a distal outer support ring 68 is provided at the distal end of the outer support member 62. The proximal inner support ring 65 and the distal inner support ring 66 are fixedly connected to the inner support member 61 by means of laser welding, soldering, hot melting, or adhesive, respectively. The proximal outer support ring 67 and the distal outer support ring 68 are fixedly connected to the outer support member 62 by means of laser welding, soldering, hot melting, or adhesive, respectively.

[0066] like Figure 9 As shown, the capsule is blow-molded from a double-lumen tube. One lumen of the double-lumen tube is blow-molded into the capsule 5. When the support device 6 is connected to the capsule 5, the inner support member 61 can be inserted into the blow-molded capsule 5 first, the inner support member 61 can be straightened, and then the proximal end of the inner support member 61 can be connected to the proximal inner support ring 65, and the distal end of the inner support member 61 can be connected to the distal inner support ring 66. Unlike Embodiment 1, in this embodiment, the outer support member 62 and the inner support member 61 do not share a support ring at both ends.

[0067] like Figure 11As shown, the telescopic tube 8 consists of an inner telescopic tube 81 and an outer telescopic tube 82. The proximal inner support ring 65 and the distal inner support ring 66 are fitted onto the inner telescopic tube 81, and the proximal outer support ring 67 and the distal outer support ring 68 are fitted onto the outer telescopic tube 82. An air inlet tube 2, a return air tube 3, a guidewire lumen tube 4, and a liner tube 12 are provided within the sheath tube 1. The distal ends of the air inlet tube 2 and the return air tube 3 are located within the capsule body 5 and are in fluid communication with it. The distal portion of the guidewire lumen tube 4 is located within the capsule body 5, and the distal end of the guidewire lumen tube 4 is sealed to the distal end of the capsule body 5. The inner telescopic tube 81 is fitted onto the distal portion of the guidewire lumen tube 4 and is located within the capsule body 5. The distal end of the inner telescopic tube 81 is sealed to the guidewire lumen tube. The proximal end of the inner telescopic tube 81 is sealed to the air inlet tube 2, the return air tube 3, the proximal end of the capsule body 5, and the proximal inner support ring 65. The distal end of the liner 12 extends out of the sheath 1 and is located outside the capsule 5. The outer telescopic tube 82 and the liner 12 are disposed within the other lumen of the double-lumen tube forming the capsule 5. The outer telescopic tube 82 is sleeved on the portion of the liner 12 extending out of the sheath 1, and the distal end of the outer telescopic tube 82 is fixedly connected to the liner 12, the distal end, the outer support ring 68, and the distal end of the other lumen of the double-lumen tube. The proximal end of the outer telescopic tube 82 is sealed to the proximal end of the other lumen of the double-lumen tube and the proximal outer support ring 67. The outer telescopic tube 13 has the same structure as the telescopic tube 8, and is preferably a corrugated tube that can be both stretched and compressed. The proximal end of the liner 12 is fixedly connected to the adjustment mechanism 72 on the handle 7, which can control the axial movement of the guidewire lumen 4 and the liner 12 respectively. The guidewire lumen 4 can move axially within the inner telescopic tube 81. When the inner guidewire lumen 4 moves distally, the inner telescopic tube 81 is in a stretched state, and the axial dimension of the inner support member 61 increases while its circumferential dimension decreases. When the inner guidewire lumen 4 moves proximally, the inner telescopic tube 81 is in a compressed state, and the axial dimension of the inner support member 61 decreases while its circumferential dimension increases. Similarly, the liner 12 can move axially within the outer telescopic tube 82. When the liner 12 moves distally, the outer telescopic tube 82 is in a stretched state, and the axial dimension of the outer support member 62 increases while its circumferential dimension decreases. When the liner 12 moves proximally, the outer telescopic tube 82 is in a compressed state, and the axial dimension of the outer support member 62 decreases while its circumferential dimension increases. Therefore, by setting the inner telescopic tube 81 and the outer telescopic tube 82, this application can adjust the size of the inner support 61 and the outer support 62 at the same time, or adjust the size of the inner support 61 and the outer support 62 separately, thus expanding the application range of the cryoablation catheter of this application, which can be applied to blood vessels of various sizes and structures as well as natural channels.

[0068] Example 3

[0069] The structure of the cryoablation catheter with support device described in this embodiment is basically the same as that in Embodiment 2, except that: First, the capsule 5 in this embodiment is blow-molded from a single lumen. Second, as... Figure 12 As shown, the telescopic tube 8 consists of an inner telescopic tube 81 and an outer telescopic tube 82. The proximal inner support ring 65 and the distal inner support ring 66 are fitted onto the inner telescopic tube 81, and the proximal outer support ring 67 and the distal outer support ring 68 are fitted onto the outer telescopic tube 82. The sheath 1 is a double-lumen tube. An air inlet tube 2, a return air tube 3, and a guidewire lumen tube 4 are disposed in the first lumen 13 of the sheath 1, and a liner tube 12 is disposed in the second lumen 14 of the sheath 1. The distal ends of the air inlet tube 2 and the return air tube 3 are disposed within the capsule body 5 and are in fluid communication with the capsule body 5. The distal portion of the guidewire lumen tube 4 is located within the capsule body 5, and the distal end of the guidewire lumen tube 4 is sealed to the distal end of the capsule body 5. The inner telescopic tube 81 is fitted onto the distal portion of the guidewire lumen tube 4 and is located within the capsule body 5. The distal end of the inner telescopic tube 81 is sealed to the guidewire lumen tube 4 and the distal inner support ring 66. The proximal end of the inner telescopic tube 81 is sealed to the inlet tube 2, the return tube 3, the proximal end of the bladder body 5, and the proximal inner support ring 65. The distal end of the liner tube 12 extends from the second cavity 14 of the sheath tube 1 and is located outside the bladder body 5. The outer telescopic tube 82 is fitted onto the extended portion of the liner tube 12, and the distal end of the outer telescopic tube 82 is fixedly connected to the liner tube 12 and the distal outer support ring 68. The proximal end of the outer telescopic tube 82 is sealed to the proximal outer support ring 67 and the inner wall of the second cavity 14. The proximal end of the liner tube 12 is fixedly connected to the adjustment mechanism 72 provided on the handle 7, and the adjustment mechanism 72 controls the axial movement of the guidewire lumen 4 and the liner tube 12 respectively. The guidewire lumen 4 moves axially along the inner telescopic tube 81. When the guidewire lumen 4 moves distally, the inner telescopic tube 81 is in a stretched state, and the axial dimension of the inner support member 61 increases while its circumferential dimension decreases. When the guidewire lumen 4 moves proximally, the inner telescopic tube 81 is in a compressed state, and the axial dimension of the inner support member 61 decreases while its circumferential dimension increases. This controls the shape and size of the capsule 5, facilitating effective contact between the capsule 5 and the target ablation area. The liner 12 can move axially within the outer telescopic tube 82. When the liner 12 moves distally, the outer telescopic tube 82 is in a stretched state, and the axial dimension of the outer support member 62 increases while its circumferential dimension decreases. When the liner 12 moves proximally, the outer telescopic tube 82 is in a compressed state, and the axial dimension of the outer support member 62 decreases while its circumferential dimension increases.

[0070] Of course, in other embodiments, the sheath 1 is a single-lumen tube, and the liner 12 can be arranged side by side on the outside of the sheath 1, with the proximal end of the outer telescopic tube 82 fixedly connected to the proximal end of the capsule 5. The applicant believes that as long as the axial movement of the liner 12 can drive changes in the axial and circumferential dimensions of the outer support 62, those skilled in the art can use any other means in the prior art to achieve this.

[0071] The technical features of the above embodiments can be combined in any way. For the sake of brevity, 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, they should be considered to be within the scope of this specification.

[0072] The embodiments described above are merely illustrative of several implementation methods of this application, and 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 those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A cryoablation catheter (100) with a support device, comprising a sheath (1), an inlet tube (2), a return tube (3), a guidewire lumen (4), a capsule (5), a support device (6), and a handle (7), wherein the inlet tube (2), the return tube (3), and the guidewire lumen (4) are all located within the sheath (1), the distal ends of the inlet tube (2) and the return tube (3) extend from the distal end of the sheath (1) and are disposed within the capsule (5) and in fluid communication with the capsule (5), the distal end of the sheath (1) is fixedly connected to the proximal end of the capsule (5), the proximal end of the sheath (1) is fixedly connected to the handle (7), and the distal end of the capsule (5) is fixedly connected to the distal end of the guidewire lumen (4), characterized in that, The support device (6) consists of an inner support member (61) and an outer support member (62). The inner support member (61) is disposed inside the cyst (5), and the outer support member (62) is disposed outside the cyst (5). The support device (6) is a self-expanding structure. When the support device (6) changes from a compressed state to an expanded state, the inner support member (61) supports the inner wall of the cyst (5), so that the cyst (5) is close to the target area. The outer support member (62) supports the inner wall of the blood vessel (10), and a blood flow channel (11) is established between the outer side of the cyst (5) and the inner wall of the blood vessel (10).

2. The cryoablation catheter with a support device according to claim 1, characterized in that, A telescopic tube (8) is sleeved on the distal part of the guidewire lumen (4). The telescopic tube (8) is located inside the bladder body (5). The proximal end of the telescopic tube (8) is sealed to the proximal end of the inner support (61), the proximal end of the outer support (62), the proximal end of the bladder body (5), the air inlet tube (2), and the air return tube (3). The distal end of the telescopic tube (8) is sealed to the guidewire lumen (4). The guidewire lumen (4) can move axially relative to the sheath tube (1), so that the telescopic tube (8) can be stretched or compressed, thereby controlling the shape and circumferential dimension changes of the inner support (61) and the outer support (62).

3. The cryoablation catheter with a support device according to claim 2, characterized in that, An adjustment mechanism (72) is provided on the handle (7). The adjustment mechanism (72) is fixedly connected to the proximal end of the guidewire lumen (4). The adjustment mechanism (72) controls the shape and circumferential dimension changes of the inner support (61) and the outer support (62) by controlling the axial movement of the guidewire lumen (4).

4. The cryoablation catheter with a support device according to claim 3, characterized in that, The capsule (5) is blow-molded from one of the lumens of the double-lumen tube.

5. A cryoablation catheter with a support device according to claim 4, characterized in that, The support device (6) is a split structure. The telescopic tube (8) consists of an inner telescopic tube (81) and an outer telescopic tube (82). The inner telescopic tube (81) is sleeved on the distal part of the guidewire lumen (4) and located inside the capsule (5). The distal end of the inner telescopic tube (81) is sealed to the distal end of the guidewire lumen (4) and the inner support member (61). The proximal end of the inner telescopic tube (81) is sealed to the proximal end of the air inlet tube (2), the air return tube (3), the capsule (5), and the inner support member (61). A liner (12) is provided along the inner cavity of the sheath (1). The distal end of the liner (12) extends out of the distal end of the sheath (1). The outer telescopic tube (82) is sleeved on the distal part of the guidewire lumen (4) and located inside the capsule (5). The portion of the liner (12) extending out of the sheath (1) is provided in the other lumen of the double-lumen tube. The distal end of the outer telescopic tube (82) is fixedly connected to the liner (12), the distal end of the outer support (62), and the distal end of the other lumen of the double-lumen tube. The proximal end of the outer telescopic tube (82) is sealed to the proximal end of the other lumen of the double-lumen tube and the proximal end of the outer support (62). The proximal end of the liner (12) is fixedly connected to the adjustment mechanism (72) on the handle (7). The adjustment mechanism (72) controls the axial movement of the guidewire lumen (4) and the liner (12).

6. A cryoablation catheter with a support device according to claim 3, characterized in that, The support device (6) is a split structure. The telescopic tube (8) consists of an inner telescopic tube (81) and an outer telescopic tube (82). The sheath tube (1) is a double-lumen tube. The air inlet tube (2), the air return tube (3), and the guide wire lumen tube (4) are arranged in the first lumen (13) of the sheath tube (1). The liner tube (12) is arranged in the second lumen (14) of the sheath tube (1). The inner telescopic tube (81) is sleeved on the distal part of the guide wire lumen tube (4) and located inside the capsule (5). The distal end of the inner telescopic tube (81) is sealed to the distal end of the guide wire lumen tube (4) and the inner support member (61). The proximal end of the inner telescopic tube (81) is connected to the proximal end of the air inlet tube (2), the air return tube (3), and the capsule (5). The end of the inner support (61) is sealed to the proximal end of the inner support (61). The distal end of the liner (12) extends from the second cavity (14) of the sheath (1) and is located outside the capsule (5). The outer telescopic tube (82) is sleeved on the part of the liner (12) that extends out of the sheath (1). The distal end of the outer telescopic tube (82) is fixedly connected to the distal end of the liner (12) and the outer support (62). The proximal end of the outer telescopic tube (82) is sealed to the proximal end of the outer support (62) and the second cavity (14). The proximal end of the liner (12) is fixedly connected to the adjustment mechanism (72) on the handle (7). The adjustment mechanism (72) controls the axial movement of the guide wire cavity (4) and the liner (12) respectively.

7. A cryoablation catheter with a support device according to claim 5 or 6, characterized in that, A proximal inner support ring (65) is provided at the proximal end of the inner support member (61), a distal inner support ring (66) is provided at the distal end of the inner support member (61), a proximal outer support ring (67) is provided at the proximal end of the outer support member (62), and a distal outer support ring (68) is provided at the distal end of the outer support member (62). The proximal inner support ring (65) and the distal inner support ring (66) are respectively fixedly connected to both ends of the inner support member (61), and the proximal outer support ring (67) and the distal outer support ring (68) are respectively fixedly connected to both ends of the outer support member (62). The proximal inner support ring (65) and the distal inner support ring (66) are sleeved on the inner telescopic tube (81), and the proximal outer support ring (67) and the distal outer support ring (68) are sleeved on the outer telescopic tube (82).

8. A cryoablation catheter with a support device according to claim 2, characterized in that, The telescopic tube (8) is a corrugated tube, or the telescopic tube (8) is a threaded tube with a spiral groove, or the telescopic tube (8) is a spring coil.

9. A cryoablation catheter with a support device according to claim 1, characterized in that, With the central axis of the guidewire lumen (4) as the axis of symmetry, the capsule (5) has an asymmetrical structure in the axial direction.

10. A cryoablation catheter with a support device according to claim 9, characterized in that, The capsule (5) has a hemispherical structure.

11. A cryoablation system, characterized in that, Includes a cryoablation device (200) and a cryoablation catheter (100) as claimed in any one of claims 1 to 10, the cryoablation catheter (100) being connected to the cryoablation device (200) via a connector (9) for delivering refrigerant from the cryoablation device (200) to the capsule (5) via the connector (9) to perform cryoablation.

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