CN116158833A

CN116158833A - Ablation system

Info

Publication number: CN116158833A
Application number: CN202111406405.1A
Authority: CN
Inventors: 王永胜; 段超; 刘成
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2021-11-24
Filing date: 2021-11-24
Publication date: 2023-05-26
Also published as: WO2023093733A1

Abstract

An ablation system includes a first catheter and a second catheter. The first conduit includes a flow conduit and an expandable member. The flow conduit includes a first fluid passage and a second fluid passage that are isolated from each other. The inflatable member is sleeved on the flow pipeline. The first fluid passage is for providing a first fluid to the inflatable member to inflate the inflatable member. The second fluid channel is for providing a second fluid for ablation to the target tissue region. The second conduit is arranged through the flow pipeline. A second catheter is exposed from the distal end of the flow conduit for potential mapping. When the second fluid is provided for ablating the target tissue area through the second fluid channel of the first catheter, the potential mapping can be simultaneously carried out at the distal end of the second catheter, so that the real-time monitoring of the intracardiac potential in the ablation process is realized, the operation steps are greatly simplified, the operation time is shortened, and the ablation treatment can be rapidly carried out.

Description

Ablation system

Technical Field

The present application relates to the field of medical devices, and in particular, to an ablation system.

Background

Research shows that both Marshall bundles and nerves are trigger foci of part of atrial arrhythmias, and are one of pathogenesis of atrial fibrillation. Although Marshall veins are small in size and difficult to ablate with conventional catheters at radio frequency or pulse, several studies have demonstrated that atrial fibrillation can be terminated by Marshall intravenous retrograde alcohol injection.

However, when atrial fibrillation is treated by retrograde alcohol injection of Marshall veins at present, the operation of measuring the intracardiac potential is quite complicated, so that the chemical ablation treatment of Marshall veins cannot be simply and rapidly performed.

Disclosure of Invention

In order to solve the foregoing problems, the present application provides an ablation system capable of simplifying a surgical procedure and improving ablation efficiency.

An ablation system includes a first catheter and a second catheter. The first conduit comprises a flow conduit and an inflatable member, the flow conduit comprising a first fluid channel and a second fluid channel isolated from each other; the expandable member is sleeved on the flow pipeline, and the first fluid channel is used for providing a first fluid for the expandable member so as to expand the expandable member; the second fluid channel is for providing a second fluid for ablation to a target tissue region; the second catheter penetrates through the flow pipeline, and the second catheter is exposed out of the distal end of the flow pipeline and is used for potential mapping.

According to the ablation system, when the second fluid channel through the first catheter provides the second fluid to ablate the target tissue area, the potential mapping can be simultaneously carried out at the far end of the second catheter, so that the real-time monitoring of the intracardiac potential in the ablation process is realized, the ablation effect can be judged according to the real-time monitored intracardiac potential, and the good treatment purpose is achieved. When the ablation effect is not good according to the intracardiac potential, the first catheter can be directly used for re-ablation, and the second catheter can be used for potential mapping through the remote end of the second catheter. Compared with the related scheme that the ablation and the mapping can only be operated separately (correspondingly, the catheter with the ablation or mapping function needs to be respectively fed into and withdrawn from the body), the ablation system provided by the application can perform intracardiac potential measurement while ablation, so that the operation steps are greatly simplified, the operation time is shortened, the ablation treatment can be rapidly performed, meanwhile, the ablation effect can be judged according to the monitored intracardiac potential, the ablation effect is ensured, and the good treatment purpose can be achieved.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings that are required in the embodiments or the description of the prior art will be briefly described below, it being obvious that the drawings in the following description are only some embodiments of the present application, and that other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.

FIG. 1 is a schematic illustration of an ablation system provided in a first embodiment of the present application;

FIG. 2 is a schematic illustration of the ablation system of FIG. 1 with a second catheter removed;

FIG. 3 is a schematic cross-sectional view of an inner tube and an outer tube of a flow conduit;

FIG. 4 is a schematic view of the distal end of the first catheter;

FIG. 5 is an enlarged schematic view of a portion of FIG. 4;

FIG. 6 is a schematic cross-sectional view of the structure of FIG. 5 taken along line A-A;

FIG. 7 is an enlarged schematic view of the distal end portion region of the first catheter shown in FIG. 4;

FIG. 8 is a schematic diagram of the assembly of the second tube, gasket, tail cap, and second conduit;

FIG. 9 is a schematic view of a second conduit;

FIGS. 10, 11 and 12 are schematic views of possible structures of the bearing part in some other embodiments;

FIG. 13 is a schematic illustration of an ablation system provided in accordance with a second embodiment of the present application;

FIG. 14 is a schematic view of the ablation system of FIG. 13 with a second catheter removed;

FIG. 15 is an enlarged schematic view of a portion of the ablation system of FIG. 14;

FIG. 16 is a schematic cross-sectional view of the structure of FIG. 15 taken along line B-B;

FIG. 17 is a schematic view of a connecting tube and an inner tube assembled together according to an embodiment of the present application;

FIG. 18 is a schematic view of an ablation system provided in a third embodiment of the present application;

FIG. 19 is a schematic view of the ablation system of FIG. 18 with a second catheter removed;

FIG. 20 is an enlarged schematic view of a portion of the ablation system of FIG. 19;

FIG. 21 is a schematic cross-sectional view of the structure of FIG. 20 taken along line C-C;

FIG. 22 is a schematic illustration of an ablation system provided in a fourth embodiment of the present application;

FIG. 23 is a schematic cross-sectional view of the structure of FIG. 22 taken along line D-D;

FIG. 24 is a schematic illustration of an ablation system provided in a fifth embodiment of the present application;

fig. 25 is an enlarged schematic view of a portion of the ablation system of fig. 24.

Detailed Description

The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all, of the embodiments of the present application. All other embodiments, based on the embodiments herein, which would be apparent to one of ordinary skill in the art without undue burden are within the scope of the present application.

The following description of the embodiments refers to the accompanying drawings, which illustrate specific embodiments in which the invention may be practiced. Directional terms, such as "upper", "lower", "front", "rear", "left", "right", "inner", "outer", "side", etc., in the present invention are merely referring to the directions of the attached drawings, and thus, directional terms are used for better, more clear explanation and understanding of the present invention, rather than indicating or implying that the apparatus or element being referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus, should not be construed as limiting the present invention.

Furthermore, the numbering of the components itself, e.g., "first," "second," etc., herein is merely used to distinguish between the described objects and does not have any sequential or technical meaning. The terms "coupled" and "connected," as used herein, are intended to encompass both direct and indirect coupling (coupling), unless otherwise indicated.

In the technical field of interventional medical instruments, the position close to an operator is generally defined as a proximal end, and the position far away from the operator is defined as a distal end; the direction of the rotation center axis of the column, the tube body and the like is defined as the axial direction, and the direction perpendicular to the axial direction is defined as the radial direction. The definitions are provided for convenience of description and are not to be construed as limiting the present application.

Referring to fig. 1 and 2, a first embodiment of the present application provides an ablation system 100A for ablating a target tissue region by means of chemical ablation treatment, so as to achieve an effect of electrical isolation, and to perform intracardiac potential measurement while ablating. The target tissue region may be located in the heart, including but not limited to Marshall veins. It will be appreciated that the target tissue region is not limited to being located in the heart, but may be located on other body tissues, and is not limited thereto.

The ablation system 100A includes a first catheter 10 and a second catheter 30. The first catheter 10 is used to ablate a target tissue region. The first conduit 10 comprises a flow conduit 11 and an expandable member 13. Referring to fig. 3, the flow channel 11 includes a first fluid channel 111 and a second fluid channel 113 isolated from each other. The inflatable member 13 is sleeved on the flow conduit 11. The first fluid channel 111 is used to provide a first fluid to the expandable member 13 to expand the expandable member 13 to effect occlusion of a blood vessel. The second fluid channel 113 is used to provide a second fluid for ablation to the target tissue region. A second conduit 30 is provided through the flow conduit 11, the second conduit 30 being exposed from the distal end of the flow conduit 11 for potential mapping.

When the ablation system 100A provides the second fluid to ablate the target tissue region through the second fluid channel 113 of the first catheter 10, the distal end of the second catheter 30 can perform potential mapping simultaneously, on one hand, real-time monitoring of the intracardiac potential in the ablation process is realized, and the ablation effect can be judged according to the real-time monitored intracardiac potential, so that the aim of good treatment is achieved, on the other hand, the ablation system 100A in the embodiment can perform intracardiac potential measurement while ablation, and separate operation of ablation and mapping is not needed, so that the operation steps are greatly simplified, and the operation time is shortened.

The flow conduit 11 comprises an inner tube 114 and an outer tube 115. The inner tube 114 is disposed through the outer tube 115. The outer wall of the inner tube 114 and the inner wall of the outer tube 113 together enclose the first fluid channel 111. The distal end of the first fluid channel 111 is closed. The inner tube 114 is provided with a second fluid channel 113. The second conduit 30 is disposed through the second fluid channel 113. The proximal end of the second catheter 30 exposes the proximal end of the inner tube 114 and the distal end of the second catheter 30 exposes the distal end of the inner tube 114. The expandable member 13 is disposed over the inner tube 114, with the proximal end of the expandable member 13 fixedly coupled to the distal end of the outer tube 115 and in communication with the first fluid passageway 111.

The inner tube 114 is coaxially disposed with the outer tube 115, with the distal end of the inner tube 114 exposing the distal end of the outer tube 115. The inner tube 114 and the outer tube 115 are made of nylon (PA). It is understood that in other embodiments, the inner tube 114 and the outer tube 115 may be disposed on different axes, and the material of the inner tube 114 and the outer tube 115 is not limited in the present application.

In this embodiment, the inner diameter of the inner tube 114 is in the range of 0.55mm to 1.4mm, the inner diameter of the outer tube 115 is in the range of 0.85mm to 1.7mm, for example, the inner diameter of the inner tube 114 is 0.70mm, and the inner diameter of the outer tube 115 is 1.20mm. It is to be understood that the present application is not limited to the inner diameter of the inner tube 114 and the present application is not limited to the inner diameter of the outer tube 115.

Further, optionally, the expandable member 13 includes a first expandable element 131 and a second expandable element 133 disposed along the axial direction of the flow conduit 11. The first expandable member 131 is fixedly coupled to the second expandable member 133. The first expandable member 131 and the second expandable member 133 are configured in series along the axial direction of the flow conduit 11 to enhance the effect of the expandable member 13 on occluding a blood vessel.

Specifically, the first inflatable member 131 has a first balloon (not shown) and the second inflatable member 133 has a second balloon (not shown). The first bladder communicates with the second bladder, which communicates with the first fluid passage 111. In other words, the first fluid channel 111 is used to input the first fluid to the first and second lumens. The distal end of the inner tube 114 sequentially passes through the second lumen of the second inflatable member 133 and the first lumen of the first inflatable member 131. The distal end of the outer tube 115 is fixedly connected to the proximal end of the second inflatable member 133.

In this embodiment, the first inflatable member 131 is substantially balloon-shaped and the second inflatable member 133 is substantially balloon-shaped. The distance between the center of the first expandable member 131 and the center of the second expandable member 133 is in the range of 4mm-12mm, for example, the distance between the center of the first expandable member 131 and the center of the second expandable member 133 is 6mm. Optionally, the first inflatable member 131 and the second inflatable member 133 each employ a semi-compliant balloon to enhance the sealing effect of the balloon. Semi-compliant balloons have a wide working range, flexible balloon sizes, and are used for pre-dilation. The materials of the first expandable member 131 and the second expandable member 133 include one of polyether block polyamide (polyetherblock amide, pebax), PA, and thermoplastic polyurethane elastomer rubber (thermoplastic polyurethanes, TPU). It is understood that the materials of the first expandable member 131 and the second expandable member 133 are not limited in this application.

The expandable member 13 includes an expanded state and a non-expanded state. The expandable member 13 is expanded by a first fluid provided by the first fluid channel 111 to enable occlusion of a blood vessel. The volume of the expandable member 13 in the expanded state is greater than the volume of the expandable member 13 in the unexpanded state. In the expanded state, the shape of the first expandable member 131, the shape of the second expandable member 133 may be a shape having a hollow cylinder as shown in fig. 4. As shown in fig. 4, the axial length of the first expandable member 131 is greater than the maximum outer diameter of the first expandable member 131, and the axial length of the second expandable member 133 is greater than the maximum outer diameter of the second expandable member 133.

It is to be understood that the shape of the first expandable member 131 is not limited in this application, and may be, for example, heart-shaped, square-shaped, spherical-shaped, etc. The shape of the second expandable member 133 is not limited in this application, and may be, for example, heart-shaped, square-shaped, spherical-shaped, or the like.

Referring to fig. 5 and 6, the expandable member 13 further includes a connection tube 135 disposed outside the flow conduit 11 for connecting the first expandable member 131 and the second expandable member 133. The distal end of the connecting tube 135 is fixedly connected to the proximal end of the first expandable member 131, and the proximal end of the connecting tube 135 is fixedly connected to the distal end of the second expandable member 133. The connection tube 135 has a lumen 1350, and the lumen 1350 communicates the first and second lumens such that the first fluid input to the second lumen enters the first lumen through the lumen 1350. The distal end of the inner tube 114 also extends through the lumen 1350.

In this embodiment, the connecting tube 135 is fixedly connected to the proximal end of the first expandable member 131 by laser welding, and the connecting tube 135 is fixedly connected to the distal end of the second expandable member 133 by laser welding. It is understood that the present application does not limit the manner of fixing the connection tube 135 to the first expandable member 131, and the present application does not limit the manner of fixing the connection tube 135 to the second expandable member 133.

In the present embodiment, the axial length of the connection tube 135 is not less than 6mm, the inner diameter of the connection tube 135 is substantially the same as the outer diameter of the distal end of the outer tube 115, and the material of the connection tube 135 is the same as the material of the outer tube 115. It is understood that the present application does not limit the length of the connection tube 135, and the present application does not limit the outer diameter size and material of the connection tube 135.

Further, in one embodiment, a break 1351 is provided in the wall of the connecting tube 135 to expose a portion of the inner tube 114. Break 1351 is generally rectangular. It is to be understood that the shape of the break 1351 is not particularly limited in this application, and may be, for example, circular, elliptical, rectangular, irregular, or the like. The flow pipe 11 is provided with an injection through hole 119 for injecting the second fluid through the side wall of the inner pipe 114, and the position of the injection through hole 119 corresponds to the position of the break 1351. The ejection through hole 119 is substantially circular. The inner wall of lumen 1350 includes a first sealing region 1353, the first sealing region 1353 being disposed around the perimeter of the break 1351. The flow conduit 11 is provided with a second sealing region 1133 surrounding the ejection through hole 119. The first sealing region 1353 is sealingly connected to the second sealing region 1133 to ensure a sealed connection between the edge of the break 1351 and the inner tube 114. The first sealing region 1353 and the second sealing region 1133 may be sealed by heat fusion or the like.

When the inflatable member 13 is in a tandem type double-balloon structure and the target tissue region is ablated, since the distal end of the inner tube 114 can jet the second fluid to the distal end section of the target tissue region and the jet through hole 119 can jet the second fluid to the middle section and the proximal end section of the target tissue region, the operation of expanding, contracting, retracting and the like the inflatable member 13 for multiple times is not needed to complete the fluid injection to the distal end section, the middle section and the proximal end section of the target tissue region, and the injection and the ablation of the second fluid to the whole target tissue region can be completed only by expanding and contracting the inflatable member 13 once. Therefore, after the inflatable member 13 adopts the tandem type double-balloon structure, not only can ablation and mapping be realized, but also the ablation of the whole target tissue area can be completed only through one operation, so that the operation steps are further simplified to a greater extent, the operation time is shortened, and the rapid ablation treatment can be realized.

Referring again to fig. 4, the first conduit 10 further includes a first developer 141 and a second developer 143. The first visualization material 141 is positioned within the inner tube 114 at a location corresponding to the first expandable member 131 to mark the location of the first expandable member 131 when the ablation system 100A is in operation. A second visualization object 143 is positioned on the inner tube 114 at a location corresponding to the second expandable member 133 to mark the location of the second expandable member 133 when the ablation system 100A is in operation. The first and

second visualizations

141 and 143 are each made of an X-ray opaque material.

In this embodiment, each of the first and second developing

objects

141 and 143 is disposed on the outer wall of the inner tube 114 and circumferentially disposed around the inner tube 114 to form an annular developing structure, the first developing object 141 is disposed substantially in the middle of the first expandable member 131, and the second developing object 143 is disposed substantially in the middle of the second expandable member 133, so that the position of the expandable member during the operation can be determined by developing the first developing object 141 and the second developing object 143, and the two developing objects are circumferentially disposed around the inner tube 114 to improve the developing effect.

It is understood that in other embodiments, the first developing substance 141 may be located on the first expandable member 131 and the second developing substance 143 may be located on the second expandable member 133.

Referring to fig. 1, 2 and 7 in combination, the first catheter 10 further includes a head end 15 disposed at a distal end of the inner tube 114. The outer diameter of the head end 15 decreases from the proximal end of the head end 15 to the distal end of the head end 15, e.g., the head end 15 is generally frustoconical to improve the tracking of the first catheter 10 and the smoothness of the first catheter 10 into the blood vessel. The head end 15 includes a hollow cavity 150 in communication with the second fluid passage 113. A second catheter 30 is threaded through head end 15 and is exposed from the distal end of head end 15.

In the present embodiment, the hardness of the head end 15 is greater than that of the inner tube 114 to improve the smoothness of the first catheter 10 into a stenosed vessel. The axial length of the head end 15 ranges from 1mm to 3mm, for example the axial length of the head end 15 is 2mm. It is to be understood that the hardness and axial length of the head end 15 are not limited in this application.

Since the short and stiff head end 15 may make the first catheter 10 easier to access to the small Marshall vein, but may also cause damage to the blood vessel, the first catheter 10 may optionally include a protective layer (not shown) applied to the outer wall of the head end 15 in one embodiment. The protective layer is softer to reduce damage to the blood vessel when the head end 15 enters the blood vessel. In the present embodiment, the material of the protective layer includes, but is not limited to, polytetrafluoroethylene (poly tetra fluoro ethylene, PTFE).

Optionally, an injection port 151 is provided on the distal peripheral wall of the head end 15 in communication with the hollow cavity 150 of the head end 15. The injection port 151 is for injecting a second fluid. The hollow cavity 150 and the injection port 151 can simultaneously inject the second fluid to increase the injection area of the second fluid, thereby improving the ablation efficiency. The number of the injection ports 151 may be one or more. When the number of the injection ports 151 is one or more, the one or more injection ports 151 are provided along the circumferential direction of the head end 15. Optionally, a step 153 is formed on the inner wall of the hollow cavity 150. The distal end of the inner tube 114 is received in the hollow cavity 150 and abuts against the step 153. The step 153 is used for limiting the cooperation between the head end 15 and the inner tube 114, so as to increase the connection stability between the head end 15 and the inner tube 114. Referring again to fig. 1 and 2, the first catheter 10 further includes a first connector 16 and a second connector 17. The first connector 16 is fixedly sleeved on the proximal end of the outer tube 115 of the flow conduit 11, and the first connector 16 is used for providing the first fluid to the first fluid channel 111. The proximal end of the inner tube 114 of the flow conduit 11 is fixedly connected to the distal end of the second connector 17, the second connector 17 being adapted to provide a second fluid to the second fluid channel 113.

More specifically, the first connector 16 includes a first tube body 161 fixedly connected to a first injection tube 163. The first pipe body 161 is connected to the first injection pipe 163 in a Y-shaped structure. The first injection tube 163 has a first fluid injection port 1631. The outer tube 115 and the inner tube 114 of the flow conduit 11 are both disposed through the first tube 161. The inner tube 114 exposes the proximal end of the first tube body 161. The first injection pipe 163 communicates with the first fluid passage 111. The first fluid injection port 1631 is used to inject a first fluid into the first tube 161 and flows into the first fluid channel 111 via the first injection tube 163 to inflate the inflatable member 13. The proximal end of the first tube 161 may be fixedly connected to the inner tube 114 passing through the first tube 161 by glue or injection molding, etc. to reduce the possibility of relative movement between the first tube 161 and the inner tube 114.

In this embodiment, the axial distance between the distal end of the second connector 17 and the proximal end of the first connector 16 ranges from, but is not limited to, 100mm to 200mm.

The second connector 17 includes a second tube body 171 and a second injection tube 173 fixedly connected. The second pipe body 171 is connected to the second injection pipe 173 in a Y-shaped structure. The second injection tube 173 has a second fluid injection port 1731. The distal end of the second tube 171 is fixedly connected to the proximal end of the inner tube 114 of the flow-through conduit 11. The second tube 171 communicates with the second fluid passage 113. The second fluid injection port 1731 is used to inject the first fluid into the second tube 171 and flows into the second fluid channel 113 through the second injection tube 173. The proximal end of the second tube 171 may be fixedly connected to the inner tube 114 passing through the second tube 171 by glue or injection molding, etc. to reduce the possibility of relative movement between the second tube 171 and the inner tube 114.

Referring to fig. 1 and 8 in combination, the second tube 171 includes a first insertion hole 1711 disposed along an axial direction of the second tube 171, and a distal end surface of the second tube 171 is provided with a flare 1713 communicating with the first insertion hole 1711. The first conduit 10 also includes a gasket 18. The gasket 18 is accommodated in the flare 1713 and is hermetically connected to the second tube 171, so as to prevent the blood, the second fluid, and the like from overflowing. The outer diameter of the seal 18 may be slightly larger than the bore of the flare 1713. The material of the gasket 18 includes, but is not limited to, silica gel. The gasket 18 is provided with a second insertion hole 181. The second catheter 30 is inserted through the first insertion hole 1711 and the second insertion hole 181.

Optionally, the first catheter 10 further comprises a tail cap 19 fixedly connected to the proximal end of the second tube 171. In this embodiment, an external thread 1715 is provided on an outer wall of the second tube 171, and an internal thread (not shown) that is adapted to the external thread 1715 is provided on the tail cap 19, and the second tube 171 is screwed to the tail cap 19. It is understood that the connection of the second tube 171 and the tail cap 19 is not limited in this application. The gasket 18 is fixedly accommodated in the tail cap 19. The proximal end of the tail cap 19 is provided with a conduit aperture 191. The second conduit 30 is disposed through the conduit hole 191.

Referring to fig. 9, the second catheter 30 includes a metal shaft tube 31, a flexible tube 32, an electrode 33, a support wire 34, and an electrical connector 35.

The distal end of the metal shaft tube 31 is fixedly connected to the proximal end of the flexible tube 32. The proximal end of the metal shaft tube 31 is fixedly connected to the electrical connector 35.

The distal end of the flexible tube 32 exposes the distal end of the inner tube 114 of the flow-through conduit 11. In the present embodiment, the material of the flexible tube 32 includes, but is not limited to, a resin material, for example, a thermoplastic polyurethane elastomer rubber (thermoplastic polyurethanes, TPU) or pebax. The proximal end of the flexible tube 32 is provided with a flaring (not shown) to facilitate insertion of the metal shaft tube 31 and thus facilitate assembly between the proximal end of the flexible tube 32 and the metal shaft tube 31. In this embodiment, the distal end of the metal shaft tube 31 is inserted into the proximal end flaring structure of the flexible tube 32 and bonded by glue or the like, and the proximal end of the metal shaft tube 31 is connected to the electrical connector 35 by glue bonding or the like. The material of the metal shaft tube 31 is not particularly limited, and may be a metal material such as stainless steel or nitinol. The inner diameter of the flexible tube 32 may range in size from 0.25mm to 1.2mm, for example, the inner diameter of the flexible tube 32 may be 0.35mm. It is to be understood that the connection between the metal shaft tube 31 and the flexible tube 32 is not limited to adhesion, and may be, for example, a clamping connection.

The flexible tube 32 includes a carrier portion 321 and a connecting portion 323. The distal end of the connecting portion 323 is fixedly connected to the proximal end of the bearing portion 321. The flaring is provided at the proximal end of the connecting portion 323. The inner diameter of the flaring is slightly larger than the outer diameter of the distal end of the metal shaft tube 31. The connection portion 323 is provided through the inner pipe 114 of the flow pipe 11. The carrying portion 321 is located outside the flow conduit 11, and the electrode 33 is disposed on the carrying portion 321.

An electrode 33 is provided at the distal end of the flexible tube 32 and is electrically connected to an electrical connector 35 for potential mapping. The electrode 33 includes a ring electrode 331 and a head electrode 333. The ring electrode 331 and the head electrode 333 are used for potential mapping. The ring electrode 331 is sleeved on the bearing portion 321 of the flexible tube 32 and is electrically connected with the electrical connector 35 through the lead 37. In the present embodiment, the number of ring electrodes 331 is plural, and the plurality of ring electrodes 331 are arranged in the axial direction of the flexible tube 32. Each ring electrode 331 is connected to the electrical connector 35 by a wire 37 to enable individual control of the voltage applied to the ring electrode 331. The wire 37 includes, but is not limited to, an enameled copper wire. A head electrode 333 is fixed to the distal-most end of the flexible tube 32, and the head electrode 333 is electrically connected to the electrical connector 35 through a wire 37. The connection mode of the lead 37, the ring electrode 331 and the head electrode 333 is welding or other connection modes.

It will be appreciated that in other embodiments, the electrode 33 may omit the head electrode 333, and potential mapping may be performed by the ring electrode 331.

It should be noted that in one possible implementation, the electrode 33 may also be configured to generate a pulsed electric field for pulsed ablation of the target tissue region. Pulse ablation uses a high-intensity pulsed electric field to irreversibly electrically puncture the cell membrane, known in the medical arts as irreversible electroporation (Irreversible electroporation, IRE), to cause apoptosis, thereby achieving non-thermal effect ablation of cells, so as not to be affected by the thermal sinking effect. The high-voltage pulse sequence generates less heat, does not need normal saline to be washed for cooling, and can effectively reduce the occurrence of air explosion, eschar and thrombus. The pulse ablation treatment time is short, the treatment time of applying a group of pulse sequences is less than 1 minute, and the whole-course ablation time is generally not more than 5 minutes. And because the reaction threshold values of different tissues to the pulse electric field are different, the method provides possibility for ablating cardiac muscle without interfering with other adjacent tissues, thereby avoiding accidental injury of the adjacent tissues. In addition, compared with other energies, pulse ablation does not need heat conduction to ablate deep tissues, and all myocardial cells distributed above a certain electric field strength are subjected to electroporation, so that the requirement on the catheter attaching pressure during ablation is reduced. Thus, even if the ablation instrument does not completely conform to the inner wall of the tissue, IRE ablation effects are not affected.

While the high voltage pulse may be selected to be the form of energy delivered through the electrode 33, other forms of energy may additionally or alternatively be emitted, such as radio frequency energy or any other suitable form of energy. That is, the electrodes 33 may also be configured to deliver radiofrequency energy or other suitable forms of energy (e.g., microwaves) to ablate a target tissue region.

The support wire 34 is disposed through the flexible tube 32 and is used for supporting the flexible tube 32. The support wire 34 includes a small diameter portion (not shown) at the distal end of the support wire 34 and a large diameter portion (not shown) at the proximal end of the support wire 34. The outer diameter of the large diameter portion is larger than that of the small diameter portion, and the small diameter portion is provided to penetrate the bearing portion 321 and the connecting portion 323 of the flexible tube 32. The support wire 34 includes, but is not limited to, nitinol. The support wire 34 has superelastic and memory properties and serves as a support to ensure a certain rigidity of the distal end of the second catheter 30. Because the distal end of the supporting wire 34 is thin and the proximal end is thick, the distal end of the second catheter 30 has rigidity and better flexibility, so that the damage of the second catheter 30 to the blood vessel during operation is reduced. The diameter of the support wire 34 may range from 0.10mm to 0.40mm, for example, the diameter of the support wire 34 may range from 0.18mm.

The electrical connector 35 is used to connect the wire 37 with the monitoring device. In this embodiment, one end of the electrical connector 35 is provided with pins for connecting the bonding wires 37, and the other end is provided with an interface structure for quick connection with the monitoring device.

In some possible implementations, as shown in fig. 10, the carrying portion 321 includes a spiral structure 3213, the spiral structure 3213 extends spirally along an axial direction of the connecting portion 323, the ring electrode 331 is disposed on the spiral structure 3213, the head electrode 333 is disposed at a distal end of the carrying portion 321, and a radial dimension of the spiral structure is equal to a diameter of a blood vessel, so that the ring electrode 331 on the carrying portion 321 can be better abutted against the blood vessel wall, thereby being beneficial to improving accuracy of intracardiac potential measurement.

Because the Marshall vein is a branch vessel of the coronary sinus, the traditional straight catheter is difficult to accurately enter. In some possible implementations, as shown in fig. 11, the carrier 321 includes a curved structure 3215, where the curved structure 3215 is disposed at a distal-most end of the carrier 321 and is disposed in curved relation to an axial direction of the connection 323. The axial bending angle of the bent structure 3215 with respect to the axial direction of the connecting part 323 or the axial bending angle of the first conduit is in a range of not less than 90 ° and not more than 150 °, i.e., the bending angle of the bent structure 3215 with respect to the axial direction of the connecting part 323 is in a range of [90 °,150 ° ]. The Marshall vein is at an angle of about 90 DEG to 150 DEG to the coronary sinus. Because the curved structure 3215 is curved at approximately the same angle relative to the axis of the connection 323 as the Marshall vein is at, the coronary sinus, the second catheter 30 may be well introduced into its blood vessel without significantly increasing manufacturing costs.

In some possible implementations, as shown in fig. 12, the carrying portion 321 includes a spiral structure 3213 and a curved structure 3215, the spiral structure 3213 extends spirally along an axial direction of the connecting portion 323, the ring electrode 331 is disposed on the spiral structure 3213, the head electrode 333 is disposed at a distal-most end of the carrying portion 321, and the curved structure 3215 is disposed at the distal-most end of the carrying portion 321 and is curved with respect to the axial direction of the connecting portion 323. The bearing portion 321 combines a spiral structure 3213 and a bent structure 3215, wherein the spiral structure 3213 can enable the ring electrode 331 on the bearing portion 321 to be better attached to the vessel wall, so that accuracy of intracardiac potential measurement is improved. The axial bending angle of the bent structure 3215 with respect to the axial direction of the connecting part 323 or the axial bending angle of the first conduit is in a range of not less than 90 ° and not more than 150 °, i.e., the bending angle of the bent structure 3215 with respect to the axial direction of the connecting part 323 is in a range of [90 °,150 ° ]. The Marshall vein is at an angle of about 90 DEG to 150 DEG to the coronary sinus. Because the curved structure 3215 is curved at approximately the same angle relative to the axis of the connection 323 as the Marshall vein is at, the coronary sinus, the second catheter 30 may be well introduced into its blood vessel without significantly increasing manufacturing costs.

Taking a target tissue region as a human heart as an example, the operation procedure of the ablation system 100A according to the first embodiment for performing an operation on the human heart will be briefly described. The first fluid comprises gas or liquid, and the second fluid is absolute ethyl alcohol. It is to be understood that the subject application does not limit the target tissue area to a human heart, such as the lungs, kidneys, or other target tissue area of an organism.

(1) Insertion of sheath

The sheath is delivered to the coronary sinus portion of the right atrium via the inferior vena cava or superior vena cava by a right femoral vein or subclavian venia puncture under local anesthesia.

(2) Guiding catheter insertion

After confirming the existence of the Marshall vein by the contrast catheter, the guide catheter is inserted into the lumen of the sheath, and the guide catheter is positioned at the opening of the Marshall vein.

(3) Insertion of the second catheter 30

A second catheter 30, which may be used in place of the guidewire, is delivered along the lumen of the guide catheter to the distal end of the Marshall vein and potentiometric.

(4) Insertion of the first catheter 10

The first catheter 10 is advanced along the second catheter 30 to the distal end of the Marshall vein and the position of the expandable member 13 is then adjusted so that the second expandable member 133 is positioned proximal to the Marshall vein and the first expandable member 131 is positioned distal in the Marshall vein.

(5) Expandable member 13 expands and ethanol injection ablates

Injecting a first fluid from the first fluid injection port 1631 of the first connector 16 into the expandable member 13 such that the expandable member 13 expands, and after expansion of the expandable member 13, slowly pushing a second fluid (4-6 ml of ethanol, typically 1ml/1 min) from the second fluid injection port 1731 of the second connector 17, the second fluid being injected along the second fluid channel 113 of the first catheter 10; bolus injection was performed a second time after 2min observation. The total of the two injections is 2-3 times, and the total of the injection amount of the second fluid is not more than 12ml.

(6) Potentiometric measurement

The Marshall vein is potentiometric with the second catheter 30 with the first catheter 10 held proximal to the Marshall vein. The ablation effect is determined according to the measurement result, and the second catheter 30 is not required to be withdrawn when the ablation is unsuccessful, so that the first catheter 10 can be directly used for re-ablation. After the ablation is finished, the second catheter 30 is retracted to the first catheter 10, and then the first catheter 10 and the second catheter 30 are retracted to the guiding catheter and the sheath tube together to complete sheath retraction.

The ablation system 100A provided in this embodiment can perform potential measurement while ablation, monitor the intracardiac potential in real time and determine the ablation effect, simplify the ablation procedure, shorten the procedure time, and improve the ablation efficiency.

Referring to fig. 13 and 14, an ablation system 100B according to a second embodiment of the present application has substantially the same structure as the ablation system 100A according to the first embodiment, except that the connection tube 135 is located outside the flow conduit 11.

More specifically, referring to fig. 15, the distal end of the flow channel 11 includes a first region 116, a second region 117, and a third region 118 disposed along the axial direction of the flow channel 11, and the second region 117 is located between the first region 116 and the third region 118. The first inflatable member 131 is located in the first region 116 and the second inflatable member 133 is located in the third region 118. Referring to fig. 16, the second region 117 includes a first disposition region 1171 and a second disposition region 1173. The first setting region 1171 is used for setting the connection pipe 135. In the present embodiment, the flow pipeline 11 includes an inner pipe 114 and an outer pipe 115 sleeved outside the inner pipe 114. The distal end of the inner tube 114 exposes the distal end of the outer tube 115.

The connection tube 135 has a lumen 1350. The number of the connection pipes 135 is plural, and the plural connection pipes 135 are located in the first disposition region 1171 of the second region 117. A plurality of connection pipes 135 are provided at intervals along the circumference of the inner pipe 114 exposing the distal end of the outer pipe 115. A gap 1353 is formed between two adjacent connection pipes 135 in the circumferential direction of the flow pipe 11 corresponding to the second disposition region 1173. The inner tube 114 is located outside the lumen 1350 of the connecting tube 135. The inner tube 114 is disposed through the first lumen of the first inflatable member 131 and the second lumen of the second inflatable member 131.

The side wall of the inner tube 114 is provided with an injection through hole 119 for injecting the second fluid. The ejection through hole 119 is located in the second disposition region 1173. The ejection through holes 119 are provided corresponding to the positions of the gaps 1353.

The cross-sectional shape of the connection pipe 135 is not limited in the present application, and for example, the cross-section of the connection pipe 135 may be circular as shown in fig. 17, or may be a sector shape. As another example, in some embodiments, referring to fig. 17, the cross section of the connecting tube 135 is substantially flat, and the connecting tube 135 includes a first side wall 1355, a second side wall 1356, a third side wall 1357, and a fourth side wall 1358. The first side wall 1355 is opposite to the third side wall 1357, and the first side wall 1335 and the third side wall 1357 are arc-shaped walls. The first side wall 1355 is in engagement with the outer wall of the inner tube 114 so that the first side wall 1355 fits snugly against the outer wall of the inner tube 114. It will be appreciated that in some embodiments, at least a portion of the outer wall of the connecting tube 135 is coincident with the outer wall of the inner tube 114 to allow the connecting tube 135 to better abut the inner tube 114.

It is understood that the present application is not limited to the structure of the flow conduit 11, for example, the flow conduit 11 may be a multi-lumen conduit, the flow conduit 11 may have a first fluid channel and a second fluid channel, in other embodiments, the number of the connection tubes 135 may be at least one, the connection tubes 135 are at least in the second region 117 and the flow conduit 11 is located outside the lumens 1350 of all the connection tubes 135, and the flow conduit 11 is disposed through the first balloon of the first inflatable member 131 and the second balloon of the second inflatable member 133.

It will be appreciated that, in other embodiments, when the number of the connection pipes 135 is at least two, at least two connection pipes 135 are disposed at intervals along the circumferential direction of the flow channel 11, a gap 1353 is formed between two adjacent connection pipes 135 along the circumferential direction of the flow channel 11, and the flow channel 11 is provided with a spray through hole 119 at a position corresponding to the gap 1353. Preferably, the number of the injection through holes 119 is the same as the number of the connection pipes 135. When the flow channel 11 is a multi-lumen tube, the side wall of the second fluid channel 113 of the flow channel 11 is provided with an ejection through hole 119.

The ablation system 100B provided in the second embodiment has the first expandable member 131 and the second expandable member 133 connected by at least one connecting tube 135, so that the structural section of the flow conduit 11 provided with the injection through hole 119 does not need to be sealed with the connecting tube 135, which is beneficial to simplifying the structure and preparation of the ablation system 100B.

Referring to fig. 18 and 19, an ablation system 100C according to a third embodiment of the present disclosure has substantially the same structure as the ablation system 100A according to the first embodiment, except that the connecting tube 135 is omitted from the first catheter 10.

More specifically, referring to fig. 20 and 21 in combination, the distal end of the flow channel 11 includes a first region 116, a second region 117, and a third region 118 disposed along the axial direction of the flow channel 11. The second region 117 is located between the first region 116 and the third region 118. The first inflatable member 131 is located in the first region 116 and the second inflatable member 133 is located in the third region 118. The second region 117 includes a first arrangement region 1171 and a second arrangement region 1173.

The expandable member 13 further includes an air guide 137 covering the first disposition region 1171 for communicating the first expandable member 131 with the second expandable member 133. The distal end of the air guide 137 is fixedly connected to the proximal end of the first expandable member 131, and the proximal end of the air guide 137 is fixedly connected to the distal end of the second expandable member 133. The air guide portion 137 has an air guide channel 1371 communicating the first balloon of the first expansion member 131 with the second balloon of the second expansion member 133. The second disposition region 1173 is exposed outside the air guide 137. The inner tube 114 forms an ejection through hole 119 for ejecting the second fluid at the second disposition region 1173 through a side wall of the second fluid passage 113. The spacing between the ejection through hole 119 and the center of the first expandable member 131 is approximately one half of the spacing between the center of the first expandable member 131 and the center of the second expandable member 133.

In this embodiment, the first expandable member 131 and the second expandable member 133 are integrally formed, and the structure is simple and the manufacturing process is simple because there is no connection tube.

It will be appreciated that the structure of the flow conduit 11 is not limited, for example, when the flow conduit 11 is a multi-lumen conduit, the side wall of the second fluid passage 113 of the flow conduit 11 forms an injection through hole 119 for injecting the second fluid at the second disposition region 1173.

Referring to fig. 22 and 23, an ablation system 100D according to a fourth embodiment of the present invention has substantially the same structure as the ablation system 100A according to the first embodiment, except that the flow conduit 11 is a multi-lumen tube.

The flow channel 11 includes a first fluid channel 111, a second fluid channel 113, and a receiving cavity 121, where the first fluid channel 111 and the second fluid channel 113 are isolated from each other, the receiving cavity 121 and the first fluid channel 111 are isolated from each other, the receiving cavity 121 and the second fluid channel 113 are isolated from each other, and the second conduit 30 is penetrating through the receiving cavity 121.

In the present embodiment, the cross-sectional shape of the flow duct 11 is substantially circular, and the cross-sectional shape of the housing chamber 121 is substantially circular. The accommodating cavity 121 is located between the first fluid channel 111 and the second fluid channel 113, the cross-sectional area of the accommodating cavity 121 is larger than that of the first fluid channel 111, and the cross-sectional area of the accommodating cavity 121 is larger than that of the second fluid channel 113, so that the movable space of the second conduit 30 in the accommodating cavity 121 is sufficient.

Since the second conduit 30 is disposed in the independent accommodating cavity 121, the second conduit 30 is not interfered by the second fluid when moving relative to the flow channel 11, which is beneficial to improving the smoothness of the movement of the second conduit 30 relative to the flow channel 11.

It is understood that the present application does not limit the cross-sectional shape of the flow conduit 11, the cross-sectional shape of the receiving cavity 121, the cross-sectional shape of the first fluid passage 111, and the cross-sectional shape of the second fluid passage 113.

Referring to fig. 24 and 25, an ablation system 100E according to a fifth embodiment of the present application has substantially the same structure as the ablation system 100A according to the first embodiment, and the inflatable member 13 further includes a third inflatable member 139, where the third inflatable member 139 has a third balloon (not shown) and the third balloon communicates with the first and second balloons.

In the fifth embodiment, the proximal end of the first inflatable member 131 is connected to and communicates with the distal end of the second inflatable member 133 via a connecting tube 135, the proximal end of the second inflatable member 133 is connected to and communicates with the distal end of the third inflatable member 139 via a connecting tube 135, and the proximal end of the third inflatable member 139 is fixedly connected to the distal end of the outer tube 115.

The connecting pipes 135 between the proximal end of the first expandable member 131 and the distal end of the second expandable member 133, and the connecting pipes 135 between the distal end of the second expandable member 133 and the distal end of the third expandable member 139 are each provided with a break 1351, the side wall of the inner tube 114 penetrating the second fluid passage 113 is provided with a jetting through hole 119 for jetting the second fluid, and the position of the jetting through hole 119 corresponds to the position of the break 1351.

The inner wall of the lumen of the connecting tube 135 includes a first sealing region disposed around the perimeter of the break 1351. The flow conduit 11 is provided with a second sealing area around the ejection through hole 119. The first sealing region is in sealing engagement with the second sealing region to ensure a sealing engagement between the edge of break 1351 and inner tube 114. The first sealing region and the second sealing region may be sealed by heat staking or the like to provide a sealed connection between the edge of the break 1351 and the inner tube 114.

The fifth embodiment of the present application provides an ablation system 100E having three inflatable members to accommodate organisms with longer vessels. For example, because some patients may have longer Marshall veins, two inflatable members may not be able to be occluded and ablated at a time, and the length of three inflatable members may be longer to effectively occlude.

It will be appreciated that the configuration of the flow conduit 11 is not limited, e.g. when the flow conduit 11 is a multi-lumen conduit, a multi-inflatable member 13 is equally applicable.

It is understood that the position of the third inflatable member 139 is not limited in this application, and for example, the third inflatable member 139 may be connected between the first inflatable member 131 and the second inflatable member 133.

It will be appreciated that in other embodiments, the expandable member 13 may also include a fourth expansion, a fifth expansion … …, and so on.

The foregoing disclosure is merely illustrative of the preferred embodiments of the present application and is not intended to limit the scope of the claims herein, as such equivalent variations are contemplated by the present application.

Claims

1. An ablation system comprising a first catheter and a second catheter, the first catheter comprising a flow conduit and an expandable member, the flow conduit comprising a first fluid passageway and a second fluid passageway isolated from each other; the expandable member is sleeved on the flow pipeline, and the first fluid channel is used for providing a first fluid for the expandable member so as to expand the expandable member; the second fluid channel is for providing a second fluid for ablation to a target tissue region; the second catheter penetrates through the flow pipeline, and the second catheter is exposed out of the distal end of the flow pipeline and is used for potential mapping.

2. The ablation system of claim 1, wherein the expandable member comprises a first expandable member and a second expandable member disposed axially along the flow conduit, the first expandable member being fixedly connected to the second expandable member, the first expandable member having a first balloon and the second expandable member having a second balloon, the first balloon being in communication with the second balloon, the second balloon being in communication with the first fluid passageway.

3. The ablation system of claim 2, wherein the expandable member further comprises a connecting tube located outside the flow conduit, the connecting tube being fixedly connected to the first expandable member, the connecting tube being fixedly connected to the second expandable member, the connecting tube having a lumen that communicates the first balloon lumen with the second balloon lumen.

4. The ablation system of claim 3, wherein the flow conduit is disposed through the lumen, the proximal end of the connecting tube is fixedly connected to the distal end of the second expandable member, and the distal end of the connecting tube is fixedly connected to the proximal end of the first expandable member.

5. The ablation system of claim 4, wherein a break is provided in a wall of the connecting tube, the flow conduit is provided with an injection through hole for injecting the second fluid through a side wall of the second fluid channel, a position of the injection through hole corresponds to a position of the break, an inner wall of the lumen includes a first sealing region, the first sealing region is disposed around a periphery of the break, the flow conduit is provided with a second sealing region around the injection through hole, and the first sealing region is in sealing connection with the second sealing region.

6. The ablation system of claim 3, wherein the distal end of the flow conduit includes a first region, a second region, and a third region disposed axially of the flow conduit, the second region being located between the first region and the third region, the first expandable member being located at the first region, the second expandable member being located at the third region, the number of connection tubes being at least one, the connection tubes being located at least at the second region and the flow conduit being located outside of the lumens of all connection tubes, the flow conduit passing through the first and second lumens.

7. The ablation system of claim 6, wherein the flow conduit is provided with an ejection orifice through a sidewall of the second fluid passage for ejecting the second fluid, the second region including a first disposed region and a second disposed region, the connecting tube being located in the first disposed region, the ejection orifice being located in the second disposed region.

8. The ablation system of claim 7, wherein the number of the connection pipes is at least two, the at least two connection pipes are arranged at intervals along the circumferential direction of the flow channel, a gap is formed between two adjacent connection pipes along the circumferential direction of the flow channel, and the position of the flow channel corresponding to the gap is provided with the jetting through hole.

9. The ablation system of claim 2, wherein the distal end of the flow conduit comprises a first region, a second region, and a third region disposed along an axial direction of the flow conduit, the second region being located between the first region and the third region; the first expandable member is positioned in the first area, the second expandable member is positioned in the third area, and the second area comprises a first setting area and a second setting area; the inflatable component still include cover in the air guide part of first setting region, the distal end of air guide part with the proximal end fixed connection of first inflatable, the proximal end of air guide part with the distal end fixed connection of second inflatable, air guide part has the intercommunication first bag chamber with the air guide passageway of second bag chamber, the second setting region exposes the outside of air guide part, the lateral wall of the second fluid passageway of circulation pipeline is in the second setting region forms the injection through-hole that is used for spraying the second fluid.

10. The ablation system of claim 2, wherein the expandable member further comprises a third expandable member having a third balloon lumen in communication with the first balloon lumen and the second balloon lumen.

11. The ablation system of claim 2, further comprising a first visualization object positioned on the first inflatable member or on the flow conduit at a location corresponding to the first inflatable member and a second visualization object positioned on the second inflatable member or on the flow conduit at a location corresponding to the second inflatable member.

12. The ablation system of any of claims 1-11, wherein the flow conduit comprises an inner tube and an outer tube, the inner tube passing through the outer tube, the inner tube being provided with the second fluid passageway; the outer wall of the inner pipe and the inner wall of the outer pipe jointly enclose the first fluid channel; the expandable member is sleeved on the inner tube, and the proximal end of the expandable member is fixedly connected with the distal end of the outer tube and is communicated with the first fluid channel.

13. The ablation system of any of claims 1-11, wherein the flow conduit is a multi-lumen conduit, the flow conduit further comprising a receiving cavity, the receiving cavity being spaced apart from the first fluid passage, the receiving cavity being spaced apart from the second fluid passage, the second conduit passing through the receiving cavity.

14. The ablation system of claim 1, wherein the first catheter further comprises a head end, a proximal end of the head end being disposed at a distal end of the flow conduit; the outer diameter of the head end decreases from the proximal end of the head end to the distal end of the head end; the head end includes a hollow cavity in communication with the second fluid passage, and the second conduit extends through the head end and emerges from a distal end of the head end.

15. The ablation system of claim 14, wherein a circumferential wall of the distal end of the head end is provided with an ejection port in communication with the hollow cavity, the ejection port being configured to eject the second fluid.

16. The ablation system of claim 14 or 15, wherein a step is formed on an inner wall of the hollow cavity, and the distal end of the flow conduit is received within the hollow cavity and abuts the step.

17. The ablation system of claim 16, wherein an outer wall of the head end is coated with a protective layer.

18. The ablation system of any of claims 1-11, wherein the first catheter further comprises a first connector and a second connector, the first connector fixedly sleeved on the flow conduit, a proximal end of the flow conduit fixedly connected to a distal end of the second connector; the second conduit penetrates through the second connector; the first connector has a first fluid injection port for injecting the first fluid into the first fluid channel; the second connector has a second fluid injection port for injecting the second fluid into the second fluid channel.

19. The ablation system of claim 18, wherein the first connector comprises a first tube fixedly connected to a first injection tube, the first injection tube having the first fluid injection port, the flow conduit passing through the first tube and exposing a proximal end of the first tube, the first injection tube in communication with the first fluid passageway.

20. The ablation system of claim 18, wherein the second connector comprises a fixedly connected second tube body and a second injection tube, the second injection tube having the second fluid injection port; the distal end of the second pipe body is fixedly connected with the proximal end of the flow pipeline, the second pipe body is communicated with the second fluid channel, and the second catheter penetrates through the second pipe body.

21. The ablation system of claim 20, wherein the second tube includes a first insertion aperture disposed axially of the second tube, a distal end face of the second tube having a flared end in communication with the first insertion aperture, the first catheter further including a gasket received within the flared end and sealingly coupled to the second tube, the gasket having a second insertion aperture, the second catheter being disposed through the first and second insertion apertures.

22. The ablation system of claim 21, wherein the first catheter further comprises a tail cap fixedly coupled to the proximal end of the second catheter body, the seal is fixedly received within the tail cap, a catheter aperture is provided at the proximal end of the tail cap, and the second catheter is disposed through the catheter aperture.

23. The ablation system of any of claims 1-11, wherein the second catheter comprises a metal shaft tube, a flexible tube, an electrode, a support wire, and an electrical connector, the distal end of the flexible tube exposing the distal end of the flow conduit, the distal end of the metal shaft tube being fixedly connected to the proximal end of the flexible tube, the proximal end of the metal shaft tube being fixedly connected to the electrical connector, the electrode being disposed at the distal end of the flexible tube and electrically connected to the electrical connector for performing electrical mapping, the support wire being disposed through the flexible tube.

24. The ablation system of claim 23, wherein the electrode is further configured to generate a pulsed electric field to pulse ablate the target tissue region; and/or the electrode is further used for transmitting radio frequency energy to perform radio frequency ablation on the target tissue region; and/or the electrodes are further configured to deliver microwave energy to perform microwave ablation of the target tissue region.

25. The ablation system of claim 23, wherein the flexible tube comprises a carrier portion and a connector portion, wherein a distal end of the connector portion is fixedly connected to a proximal end of the carrier portion, the connector portion is disposed through the flow conduit, the carrier portion is disposed outside the flow conduit, the electrode is disposed on the carrier portion, the carrier portion comprises a spiral structure and/or a curved structure, the spiral structure extends helically along an axial direction of the connector portion, and the curved structure is disposed at a distal-most end of the carrier portion and is curved with respect to the axial direction of the connector portion.

26. The ablation system of claim 23, wherein the support wire comprises a small diameter portion at a distal end of the support wire and a large diameter portion at a proximal end of the support wire, the large diameter portion having an outer diameter greater than an outer diameter of the small diameter portion, the small diameter portion being disposed through the flexible tube.

27. The ablation system of claim 23, wherein the electrode comprises a ring electrode and a tip electrode, the ring electrode being disposed over the flexible tube and electrically connected to the electrical connector, the tip electrode being secured to a distal-most end of the flexible tube, the tip electrode being electrically connected to the electrical connector.