Cryoablation catheter with supporting device and system

Abstract

The invention 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] The present application relates to the technical field of medical devices, and in particular to a cryoablation catheter and system with a support device. Background Art

[0002] Balloon catheter ablation is a minimally invasive interventional treatment that uses cryoenergy for ablation. Compared with radiofrequency catheter ablation, cryoballoon technology is easier for doctors to operate, significantly shortens the operation time, and reduces patient pain. The balloons currently widely used in clinical practice are mostly for isolating the pulmonary vein potential in atrial fibrillation. Therefore, the target blood vessels for ablation are only the pulmonary veins, and they cannot be widely used in other blood vessels and natural cavities. In the vascular field, since conventional cryoballoon catheters need to block the blood vessels, blood flow must be interrupted during the ablation process. Therefore, when applied to the pulmonary artery, renal artery, and branch arteries, it is easy to cause damage to normal tissues and lead to complications. In the field of natural cavities and skin, the freezing range of conventional cryoballoon catheters is uncontrollable and non-selective, which will cause damage to normal tissues. In addition, during the ablation process, the problem of ablation adhesion is also a major pain point during the operation. Summary of the Invention

[0003] To address the deficiencies in the prior art, the present application provides a cryoablation catheter and system with a support device.

[0004] The purpose of this application is achieved through the following technical solutions:

[0005] The tube is threaded with the outer cover of the second insulator and the outer cover of the second insulator is threaded with the support member to form a circle around the tube. The tube is threaded with the support member to form a circle around the tube. The tube is threaded with the support member to form a circle around the tube. The tube is threaded with the support member to form a circle around the tube.

[0006] In an optional embodiment, a telescopic tube is sleeved on the distal end of the guidewire lumen, and the telescopic tube is located in the sac. The proximal end of the telescopic tube is sealedly connected to the proximal end of the inner support, the proximal end of the outer support, the proximal end of the sac, the air inlet pipe, and the air return pipe. The distal end of the telescopic tube is sealedly connected to the guidewire lumen, and the guidewire lumen can move axially relative to the sheath tube, so that the telescopic tube can be stretched or compressed, thereby controlling the shape and circumferential size changes of the inner support and the 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 laser welding, soldering, hot melting or gluing.

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

[0009] In an optional embodiment, the balloon is blow-molded from one lumen of a double-lumen tube.

[0010] In an optional embodiment, the support device is a split structure, and the telescopic tube consists of an inner telescopic tube and an outer telescopic tube. The inner telescopic tube is sleeved on the distal part of the guidewire lumen and is located in the sac. The distal end of the inner telescopic tube is sealed with the guidewire lumen and the distal end of the inner support. The proximal end of the inner telescopic tube is sealed with the air inlet pipe, the air return pipe, the proximal end of the sac and the proximal end of the inner support. A liner is provided along the inner cavity of the sheath tube, and the distal end of the liner extends out of the distal end of the sheath tube. The outer telescopic tube is sleeved on The portion of the liner tube extending out of the sheath tube, the outer telescopic tube and the portion of the liner tube extending out of the sheath tube are arranged in the other lumen of the double-lumen tube, the distal end of the outer telescopic tube is fixedly connected to the liner tube, 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 sealedly connected 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 tube is fixedly connected to the adjustment mechanism on the handle, and the adjustment mechanism controls the axial movement of the guide wire lumen and the liner tube respectively.

[0011] In an optional embodiment, the support device is a split structure, the telescopic tube is composed 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 guide wire lumen are arranged in the first lumen of the sheath, and a liner is arranged in the second lumen of the sheath, the inner telescopic tube is sleeved on the distal end of the guide wire lumen and is located in the sac, the distal end of the inner telescopic tube is sealed with the guide wire lumen and the distal end of the inner support, and the proximal end of the inner telescopic tube is connected to the air inlet tube, the air return tube, and the sac The proximal end of the body is sealedly connected to the proximal end of the inner support member, the distal end of the liner extends from the second cavity of the sheath tube and is located on the outside of the sac body, the outer telescopic tube is sleeved on the part of the liner extending out of the sheath tube, the distal end of the outer telescopic tube is fixedly connected to the liner tube and the distal end of the outer support member, the proximal end of the outer telescopic tube is sealedly connected to the proximal end of the outer support member and the second cavity, the proximal end of the liner tube is fixedly connected to the adjusting mechanism on the handle, and the adjusting mechanism controls the axial movement of the guide wire cavity and the liner tube respectively.

[0012] In an 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 fixedly connected to the two ends of the inner support member respectively, the proximal outer support ring and the distal outer support ring are fixedly connected to the two ends of the outer support member respectively, 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 an optional embodiment, the central axis of the guidewire lumen is used as the axis of symmetry, and the capsule is an asymmetric structure in the axial direction. Preferably, the capsule is a hemispherical structure.

[0014] In an optional embodiment, the telescopic tube is a bellows, or the telescopic tube is a threaded tube with a spiral groove, or the telescopic tube is a spring coil.

[0015] On the other hand, an embodiment of the present application provides a cryoablation system, including a cryoablation device and the above-mentioned cryoablation catheter, wherein the cryoablation catheter is connected to the cryoablation device via a connector and is used to transport the refrigerant in the cryoablation device to the sac to perform cryoablation.

[0016] Compared with the prior art, the advantages of the embodiments of the present application are:

[0017] 1. In an embodiment of the present application, the support device is composed of two parts: an internal support member and an external support member. The internal support member is arranged inside the capsule, which helps the capsule to directly adhere to the target ablation area, thereby improving the ablation efficiency. The external support member is arranged outside the capsule and supported on the blood vessel wall, thereby 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 positioning of the freezing unit, but also facilitates blood flow, solving the problems of blood flow interruption and the inability of the capsule to completely adhere to the target tissue when using a balloon for cryoablation in the prior art.

[0018] 2. In an embodiment of the present application, a telescopic tube is disposed outside the guidewire lumen, and the telescopic tube can move axially relative to the guidewire lumen, thereby driving the support member fixedly connected to the distal end of the telescopic tube to expand or contract.

[0019] 3. In an embodiment of the present application, the telescopic tube is composed of an inner telescopic tube and an outer telescopic tube. The inner telescopic tube is sleeved outside the guide wire lumen, and the outer telescopic tube is sleeved outside the liner tube. The inner telescopic tube can adjust the size of the inner support member, and the outer telescopic tube is used to adjust the size of the outer support member. The separate regulation of the sizes of the inner support member and the outer support member expands the application range of the cryoablation catheter of the present application, and can be applicable to blood vessels and natural channels of various sizes and structures. BRIEF DESCRIPTION OF THE DRAWINGS

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

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

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

[0023] Figure 4A and Figure 4B Schematic diagram of the structure of various embodiments of the balloon of a cryoablation catheter.

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

[0025] Figure 6 for Figure 1 Schematic diagram of the right side of the distal portion of the cryoablation catheter.

[0026] Figure 7A and Figure 7B Schematic diagram of the combined structure of the inner support member and the outer support member of the cryoablation catheter in Example 1.

[0027] Figure 8 Schematic diagram of the cryoablation system.

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

[0029] Figure 10A and Figure 10B Schematic diagram of the structure of the split support device of the cryoablation catheter in Example 2.

[0030] Figure 11 Schematic diagram of the structure of the distal end portion of the cryoablation catheter in Example 2.

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

[0032] Reference numerals:

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

[0034] 1-sheath; 2-air inlet tube; 3-air return tube; 4-guidewire lumen; 5-cyst; 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 member; 62-outer support member; 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-computer interaction module; 202-control module; 203-gas path module. DETAILED DESCRIPTION

[0035] 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.

[0036] In the description of this application, it should be understood that if 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", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing this application and simplifying the description, and does 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 cannot be understood as a limitation on this application.

[0037] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of technical features indicated. Therefore, a feature specified as "first" or "second" may explicitly or implicitly include at least one of such features. In the description of this application, if the term "plurality" appears, "plurality" means at least two, for example, two, three, etc., unless otherwise specifically defined.

[0038] In this application, unless otherwise specified or limited, the terms "mounted," "connected," "connected," "fixed," etc., should be interpreted broadly. For example, these terms may refer to fixed connections, removable connections, or integration; mechanical connections or electrical connections; direct connections or indirect connections through an intermediary; and internal communication between two components or interaction between two components, unless otherwise specified. Those skilled in the art will understand the specific meanings of these terms in this application based on the specific circumstances.

[0039] In this application, unless otherwise expressly specified or limited, if a first feature is described as being "above" or "below" a second feature, or similar descriptions, this may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Furthermore, when a first feature is described as being "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 described as being "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.

[0040] It should be noted that if 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. If 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. If any, 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 embodiment.

[0041] The proximal end mentioned in this application refers to the end close to the surgical operator, and the distal end refers to the end far away from the surgical operator.

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

[0043] Example 1

[0044] like Figure 1 As shown, the present application provides a cryoablation catheter 100 with a support device, comprising a sheath 1, an air inlet tube 2, an air return tube 3, a guidewire lumen 4, a capsule 5, a support device 6 and a handle 7, wherein the air inlet tube 2, the air return tube 3 and the guidewire lumen 4 are all located in the sheath 1, the distal ends of the air inlet tube 2 and the air return tube 3 extend out of the distal end of the sheath 1 and are arranged in the capsule 5 and are fluidically connected to 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, the air inlet tube 2 and the air return tube 3 are connected to the joint 9, the distal end of the capsule 5 is fixedly connected to the distal end of the guidewire lumen 4, and is characterized in that, as Figure 2 As shown, the support device 6 is composed of an inner support member 61 and an outer support member 62. The inner support member 61 is arranged inside the bladder 5, and the outer support member 62 is arranged outside the bladder 5. The support device 6 is a self-expanding structure. Figure 5 As shown, during operation, the cryoablation catheter of the present 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 converted from a compressed state to an expanded state, the inner support member 61 supports the inner wall of the balloon 5 so that the balloon 5 is in close contact with the target area of ​​the blood vessel. The outer support member 62 is supported on the inner wall of the blood vessel 10, and a blood flow channel 11 is established between the outer side of the balloon 5 and the inner wall of the blood vessel 10. The internal support member 61 of the present application is provided inside the balloon 5, which helps the balloon 5 to directly adhere to the target ablation area and improve the ablation efficiency. The external support member 62 is provided outside the balloon 5 and supported on the blood vessel wall. This structure not only improves the stability of the positioning of the freezing unit, but also facilitates the passage of blood, solving the problems of blood flow interruption and the incomplete adhesion of the balloon 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 end of the guidewire lumen 4, and the telescopic tube 8 is located in the capsule 5. The proximal end of the telescopic tube 8 is sealed with the proximal end of the inner support 61, the proximal end of the outer support 62, the proximal end of the capsule, the air inlet pipe 2, and the air return pipe 3. The distal end of the telescopic tube 8 is sealed with the guidewire lumen 4, and the sealing connection method includes but is not limited to hot melting, gluing, laser welding, etc. 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 size changes of the inner support 61 and the outer support 62. When the guidewire lumen 4 moves toward the distal direction, the telescopic tube 8 is in a stretched state, the axial dimensions of the inner support member 61 and the outer support member 62 become larger, and the circumferential dimensions become smaller; when the guidewire lumen 4 moves toward the proximal direction, the telescopic tube 8 is in a compressed state, the axial dimensions of the inner support member 61 and the outer support member 62 become smaller, and the circumferential dimensions become larger.

[0046] like Figure 1 As shown, the sheath 1 is an adjustable bend tube, and the inner cavity of the sheath 1 is a vacuum insulation cavity. A bending adjustment mechanism 71 is provided on the handle 7, and the bending adjustment mechanism 71 controls the bending shape of the sheath 1 through a pull wire (not shown in the figure). The pull wire is fixed in the tube wall of the sheath 1, the distal end of the pull wire is connected to the distal end of the sheath 1, and the proximal end of the pull wire is connected to the bending adjustment mechanism 71. By setting the bending adjustment mechanism 71, the curvature of the sheath 1 can be adjusted so that the capsule 5 can better fit the target tissue. Furthermore, there are two pull wires, and the two pull wires are symmetrically arranged on both sides of the sheath 1. In this way, the cryoablation catheter can be bent in both directions, which is more flexible to use. The material of the adjustable bend is preferably PTFE, Pebax, or 304 stainless steel. The handle 7 is further 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 size of the inner support 61 and the outer support 62 by controlling the axial movement of the guidewire lumen 4, thereby controlling the shape and size of the capsule 5. The adjustment structure 72 can be a structure in which a slider and a chute cooperate, or other structures in the prior art that can control the axial movement of the guidewire lumen 4 can be selected, which will not be described in detail here.

[0047] In one embodiment, a temperature sensor is provided on the inner support member 61. The connector 9 includes an air inlet connector, an air return connector, a vacuum connector, and a temperature sensor connector. The air inlet connector communicates with the air inlet pipe 2, the air return connector communicates with the air return pipe 3, the vacuum connector communicates with the vacuum insulation cavity within the sheath tube 1, and the temperature sensor connector is connected to the 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. The cryoablation device delivers refrigerant to the air inlet pipe 2 via the connector 9. The refrigerant is then delivered to the bladder 5 through the air inlet pipe 2 to achieve cryoablation of the target area. The refrigerant is then recovered to the cryoablation device via the air return pipe 3, or the refrigerant is discharged from the air return connector via the air return pipe 3. The refrigerant includes, but is not limited to, N2, N2O, liquid nitrogen, etc. In one embodiment, the portion of the air inlet pipe 2 located within the bladder 5 is provided with a plurality of jet holes, through which the refrigerant is injected into the bladder 5. The provision of the jet holes allows for more uniform injection of the refrigerant into the bladder, improving freezing efficiency.

[0048] In one embodiment, Figure 3 As shown, the telescopic tube 8 is a bellows that can be stretched and compressed. In another embodiment, the telescopic tube 8 is a threaded tube with a spiral groove. In 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 other shapes, such as Figure 6 As shown, with the central axis of the guidewire lumen 4 as the symmetry axis, the capsule 5 is an asymmetric structure in the axial direction. In one embodiment, as shown in FIG. Figure 4A and Figure 4B As shown, the capsule 5 is hemispherical. The capsule 5 can be blow-molded by 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 FIG7 , the support device 6 comprises 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 of the support device. The proximal support ring 63 and the distal support ring 64 are fixedly connected to the support device 6 by laser welding, soldering, hot melt, or gluing. When the support device 6 is connected to the capsule 5, the inner support member 61 can be first inserted into the blow-molded capsule 5, straightened, and then the proximal end of the inner support member 61 is connected to the proximal support ring 63, and the distal end of the inner support member 61 is connected to the distal support ring 64. The 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 sealedly connected to the proximal end of the air inlet pipe 2, the air return pipe 3, the telescopic tube 8, and the proximal end of the sac 5. The distal support ring 64 is sealedly connected to the distal end of the telescopic tube 8. Both the inner support member 61 and the outer support member 62 can be made of a plurality of sheet-shaped, filament-shaped, or rod-shaped 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 melt, adhesive, etc.

[0051] On the other hand, an embodiment of the present application provides a cryoablation system, referring to Figure 7, comprising a cryoablation device 200 and the above-mentioned cryoablation catheter 100, wherein the cryoablation catheter 100 is connected to the cryoablation device 200 via a connector 9, and is used to transport the refrigerant in the cryoablation device 200 to the sac 5 via the connector 9, and perform cryoablation.

[0052] Specifically, the cryoablation device 200 in this embodiment includes a human-computer interaction module 201, a control module 202, and a gas circuit module 203. The human-computer interaction module 201 is electrically connected to the control module 202, which is in turn electrically connected to the gas circuit module 203. The gas circuit module 203 can be connected to the handle 7 of the cryoablation catheter 100 via connector 9. The gas circuit module 203 of the cryoablation device is connected to the air inlet and return connectors on the handle 7 via connector 9, respectively, for delivering refrigerant to or recovering refrigerant from the cryoablation catheter 100. The gas circuit module 203 of the cryoablation device is connected to the vacuum connector provided on connector 9 via connector 9, thereby maintaining a vacuum state within the lumen of the sheath 1 to prevent loss of cooling during refrigerant delivery and frosting of the sheath 1. A thermocouple connector provided on connector 9 is connected to the control module 202 to monitor the temperature within the bladder 5. The above is an exemplary description of a cryoablation system. In actual applications, the cryoablation device 200 can also utilize other existing technical solutions, which will not be further described here.

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

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

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

[0056] S3: The distal end of the cryoablation catheter is delivered to the ablation position by controlling the bending mechanism at the handle.

[0057] S4: Push the distal end of the cryoablation catheter out of the outer sheath and control the adjustment mechanism at the handle to expand the support mechanism at the ablation position. According to the ablation area requirements, the guidewire lumen is moved axially by controlling the adjustment mechanism at the handle. At the same time, the axial and circumferential dimensions of the support mechanism are controlled to make the inner support mechanism abut against the ablated tissue for pre-positioning. When the guidewire lumen moves toward the distal end, the telescopic tube is in a stretched state, the axial dimension of the support mechanism increases, and the circumferential dimension decreases. When the guidewire lumen moves toward the proximal end, the telescopic tube is in a compressed state, the axial dimension of the support member decreases, and the circumferential dimension increases.

[0058] S5: The refrigerant in the cryoablation device enters the air inlet pipe through the air inlet connector, and is ejected through the spray hole provided at the distal end of the air inlet pipe and enters the capsule.

[0059] S6: After the refrigerant (which may be liquid nitrogen, liquid nitrous oxide, or other low-temperature medium) enters the bladder, the bladder is filled to perform cryoablation on the target tissue. When the bladder is filled, blood flow in the channel between the bladder and the outer support member is normal.

[0060] S7: The temperature sensor installed on the inner support inside the capsule feeds back the real-time temperature, and the cryoablation device automatically adjusts according to the fed-back temperature to avoid complications caused by excessively low temperature.

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

[0062] S9: After the ablation is completed, the adjustment mechanism unit at the control handle is controlled to shrink and withdraw the support device and the capsule.

[0063] Example 2

[0064] The structure of the cryoablation catheter with a support device described in this embodiment is basically the same as that in the first embodiment, 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 arranged inside the capsule 5, and the outer support member 62 is arranged outside the capsule 5. 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 the inner support member 61 by laser welding, soldering, hot melting or gluing, and the proximal outer support ring 67 and the distal outer support ring 68 are respectively fixedly connected to the outer support member 62 by laser welding, soldering, hot melting or gluing.

[0066] like Figure 9 As shown, the bladder body is blow-molded using a double-lumen tube. One lumen of the double-lumen tube is blow-molded into the bladder body 5. When the support device 6 is connected to the bladder body 5, the inner support member 61 can be first inserted into the blow-molded bladder body 5, 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 the first embodiment, in this embodiment, the outer support member 62 and the inner support member 61 do not share a support ring.

[0067] like Figure 11As shown, the telescopic tube 8 is composed 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 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. An air inlet pipe 2, an air return pipe 3, a guide wire lumen 4 and a liner 12 are provided in the sheath tube 1. The distal ends of the air inlet pipe 2 and the air return pipe 3 are arranged in the sac 5 and are in fluid communication with the sac 5. The distal end of the guide wire lumen 4 is located in the sac 5, and the distal end of the guide wire lumen 4 is sealed and connected to the distal end of the sac 5. The inner telescopic tube 81 is sleeved on the distal end of the guide wire lumen 4 and is located in the sac 5. The distal end of the inner telescopic tube 81 is sealed and connected to the guide wire lumen. The proximal end of the inner telescopic tube 81 is sealed and connected to the proximal inner support ring 65 of the air inlet pipe 2, the air return pipe 3, the proximal end of the sac 5 and the proximal inner support ring 65. The distal end of the liner tube 12 extends out of the sheath tube 1 and is located on the outside of the capsule 5. The outer telescopic tube 82 and the liner tube 12 are arranged in the other lumen of the double-lumen tube made of the capsule 5. The outer telescopic tube 82 is sleeved on the portion of the liner tube 12 extending out of the sheath tube 1, and the distal end of the outer telescopic tube 82 is fixedly connected to the liner tube 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 sealedly connected 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 bellows that can be both stretched and compressed. The proximal end of the liner tube 12 is fixedly connected to the adjustment mechanism 72 on the handle 7, and the adjustment mechanism 72 can control the axial movement of the guide wire lumen 4 and the liner tube 12 respectively. The guidewire lumen 4 can move axially within the inner telescopic tube 81. When the inner guidewire lumen 4 moves toward the distal end, the inner telescopic tube 81 is in a stretched state, the axial dimension of the inner support member 61 increases, and the circumferential dimension decreases. When the inner guidewire lumen 4 moves toward the proximal end, the inner telescopic tube 81 is in a compressed state, the axial dimension of the inner support member 61 decreases, and the circumferential dimension increases. Similarly, the liner tube 12 can move axially within the outer telescopic tube 82. When the liner tube 12 moves toward the distal end, the outer telescopic tube 82 is in a stretched state, the axial dimension of the outer support member 62 increases, and the circumferential dimension decreases. When the liner tube 12 moves toward the proximal end, the outer telescopic tube 82 is in a compressed state, the axial dimension of the outer support member 62 decreases, and the circumferential dimension increases. Therefore, the present application can adjust the sizes of the inner support member 61 and the outer support member 62 at the same time or separately through the setting of the inner telescopic tube 81 and the outer telescopic tube 82, thereby expanding the application scope of the cryoablation catheter of the present application and being applicable to blood vessels and natural channels of various sizes and structures.

[0068] Example 3

[0069] The structure of the cryoablation catheter with support device described in this embodiment is basically the same as that in the second embodiment, except that: first, the capsule 5 of this embodiment is blow-molded by a single-lumen tube. Second, Figure 12 As shown, the telescopic tube 8 is composed 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 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. The sheath tube 1 is a double-lumen tube, and an air inlet tube 2, an air return tube 3, and a guidewire lumen 4 are arranged in the first lumen 13 of the sheath tube 1, and a liner tube 12 is arranged in the second lumen 14 of the sheath tube 1. The distal ends of the air inlet tube 2 and the air return tube 3 are arranged in the capsule 5 and are in fluid communication with the capsule 5. The distal end of the guidewire lumen 4 is located in the capsule 5, and the distal end of the guidewire lumen 4 is sealed and connected to the distal end of the capsule 5. The inner telescopic tube 81 is sleeved on the distal end of the guidewire lumen 4 and is located in the capsule 5. The distal end of the inner telescopic tube 81 is sealed and connected to the guidewire lumen 4 and the distal inner support ring 66. The proximal end of the inner telescopic tube 81 is sealedly connected to the air inlet pipe 2, the air return pipe 3, the proximal end of the sac 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 on the outside of the sac 5. The outer telescopic tube 82 is sleeved on the protruding 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 sealedly connected 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 cavity 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 inner support member 61 becomes larger in axial direction and smaller in circumferential direction. When the guidewire lumen 4 moves proximally, the inner telescopic tube 81 is in a compressed state, and the inner support member 61 becomes smaller in axial direction and larger in circumferential direction, thereby controlling the shape and size of the capsule 5 and facilitating the capsule 5 to effectively fit the target ablation area. The liner tube 12 can move axially within the outer telescopic tube 82. When the liner tube 12 moves distally, the outer telescopic tube 82 is in a stretched state, and the outer support member 62 becomes larger in axial direction and smaller in circumferential direction. When the liner tube 12 moves proximally, the outer telescopic tube 82 is in a compressed state, and the outer support member 62 becomes smaller in axial direction and larger in circumferential direction.

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

[0071] 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.

[0072] 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 (100) with a supporting device, comprising a sheath (1), an air inlet tube (2), an air return tube (3), a guidewire lumen (4), a capsule (5), a supporting device (6) and a handle (7), wherein the air inlet tube (2), the air return tube (3) and the guidewire lumen (4) are all located in the sheath (1), the distal ends of the air inlet tube (2) and the air return tube (3) extend out of the distal end of the sheath (1) and are arranged in the capsule (5) and are fluidically connected to 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), the distal end of the capsule (5) is fixedly connected to the distal end of the guidewire lumen (4), and is characterized in that: The support device (6) is composed of an inner support member (61) and an outer support member (62), wherein the inner support member (61) is arranged inside the sac (5), and the outer support member (62) is arranged outside the sac (5). The support device (6) is a self-expanding structure. When the support device (6) is converted from a compressed state to an expanded state, the inner support member (61) supports the inner wall of the sac (5) so that the sac (5) is closely attached to the target area, and the outer support member (62) supports the inner wall of the blood vessel (10) to establish a blood flow channel (11) between the outer side of the sac (5) and the inner wall of the blood vessel (10).

2. A cryoablation catheter with a support device according to claim 1, characterized in that: A telescopic tube (8) is sleeved on the distal end of the guidewire lumen (4), and the telescopic tube (8) is located in the capsule (5). The proximal end of the telescopic tube (8) is sealedly connected to the proximal end of the inner support member (61), the proximal end of the outer support member (62), the proximal end of the capsule (5), the air inlet pipe (2), and the air return pipe (3). The distal end of the telescopic tube (8) is sealedly connected 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 size changes of the inner support member (61) and the outer support member (62).

3. The cryoablation catheter with a support device according to claim 1, characterized in that: The handle (7) is provided with an adjustment mechanism (72), and 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 size changes of the inner support member (61) and the outer support member (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 lumen of the double-lumen tube.

5. The cryoablation catheter with a support device according to claim 4, characterized in that: The supporting 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 end of the guidewire lumen (4) and is located in the capsule (5). The distal end of the inner telescopic tube (81) is sealed and connected 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 and connected to the inlet pipe (2), the return pipe (3), the proximal end of the capsule (5) and the proximal end of the inner support member (61). A liner tube (12) is arranged along the inner cavity of the sheath tube (1). The distal end of the liner tube (12) extends out of the distal end of the sheath tube (1). The outer telescopic tube (82) is sleeved on the distal end of the guidewire lumen (4). The portion of the liner tube (12) extending out of the sheath tube (1), the outer telescopic tube (82) and the portion of the liner tube (12) extending out of the sheath tube (1) are arranged in the other lumen of the double-lumen tube, the distal end of the outer telescopic tube (82) is fixedly connected to the liner tube (12), the distal end of the outer support member (62) and the distal end of the other lumen of the double-lumen tube, the proximal end of the outer telescopic tube (82) is sealedly connected to the proximal end of the other lumen of the double-lumen tube and the proximal end of the outer support member (62), the proximal end of the liner tube (12) is fixedly connected to the adjustment mechanism (72) on the handle (7), and the adjustment mechanism (72) respectively controls the axial movement of the guide wire lumen (4) and the liner tube (12).

6. The cryoablation catheter with a support device according to claim 3, characterized in that: The supporting device (6) is a split structure. The telescopic tube (8) is composed 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 (4) are arranged in the first lumen (13) of the sheath tube (1). A 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 end of the guide wire lumen (4) and is located in the capsule (5). The distal end of the inner telescopic tube (81) is sealedly connected to the distal end of the guide wire lumen (4) and the inner support member (61). The proximal end of the inner telescopic tube (81) is sealedly connected to the proximal end of the air inlet tube (2), the air return tube (3) and the capsule (5). The distal end of the liner (12) extends out from the second cavity (14) of the sheath tube (1) and is located on the outside of the capsule (5); the outer telescopic tube (82) is sleeved on the portion of the liner (12) extending out of the sheath tube (1); the distal end of the outer telescopic tube (82) is fixedly connected to the liner (12) and the distal end of the outer support member (62); the proximal end of the outer telescopic tube (82) is sealedly connected to the proximal end of the outer support member (62) and the second cavity (14); the proximal end of the liner (12) is fixedly connected to the adjusting mechanism (72) on the handle (7); the adjusting 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 the two ends of the inner support member (61); the proximal outer support ring (67) and the distal outer support ring (68) are respectively fixedly connected to the two 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); the proximal outer support ring (67) and the distal outer support ring (68) are sleeved on the outer telescopic tube (82).

8. The 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) is an asymmetric structure in the axial direction.

9. The cryoablation catheter with a support device according to claim 8, characterized in that: The capsule (5) is a hemispherical structure.

10. The cryoablation catheter with a support device according to claim 1, 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.

11. A cryoablation system, characterized in that: It comprises a cryoablation device (200) and a cryoablation catheter (100) as described in claims 1 to 10, wherein the cryoablation catheter (100) is connected to the cryoablation device (200) via a connector (9) and is used to transport the refrigerant in the cryoablation device (200) into the balloon (5) via the connector (9) to perform cryoablation.

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