WO2023093733A1

WO2023093733A1 - Ablation system

Info

Publication number: WO2023093733A1
Application number: PCT/CN2022/133571
Authority: WO
Inventors: 段超; 刘成
Original assignee: 杭州德诺电生理医疗科技有限公司
Priority date: 2021-11-24
Filing date: 2022-11-22
Publication date: 2023-06-01
Also published as: CN116158833A

Abstract

An ablation system (100A), comprising a first catheter (10) and a second catheter (30). The first catheter (10) comprises a circulation conduit (11) and an expandable member (13). The circulation conduit (11) comprises a first fluid channel (111) and a second fluid channel (113) isolated from each other. The expandable member (13) is sleeved on the circulation conduit (11). The first fluid channel (111) is used for providing a first fluid to the expandable member (13) to expand the expandable member (13). The second fluid channel (113) is used for providing a second fluid for ablation to a target tissue region. The second catheter (30) passes through the circulation conduit (11), and the second catheter (30) is exposed from the distal end of the circulation conduit (11) for potential mapping. When the second fluid is provided through the second fluid channel (113) of the first catheter (10) to ablate the target tissue region, the distal end of the second catheter (30) can perform potential mapping at the same time, thereby realizing real-time monitoring of the intracardiac potential during the ablation process, greatly simplifying the operation steps, shortening the operation time; therefore, ablation treatment can be quickly performed.

Description

Ablation system

This application claims the priority of a Chinese patent application with application number 202111406405.1 (application title "Ablation System") filed with the State Intellectual Property Office of China, the entire contents of which are incorporated herein by reference.

technical field

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

Background technique

Studies have shown that both the Marshall bundle and nerves are the trigger foci of some atrial arrhythmias, which is one of the pathogenesis of atrial fibrillation. Despite the small size of the Marshall vein and the difficulty of radiofrequency or pulse ablation with conventional catheters, several studies have demonstrated that retrograde alcohol injection through the Marshall vein can terminate AF.

However, at present, when retrograde alcohol injection is used to treat atrial fibrillation through the Marshall vein, the operation of intracardiac potential measurement is quite cumbersome, which makes it impossible to perform simple and rapid chemical ablation of the Marshall vein.

Contents of the invention

In order to achieve the above purpose, the implementation mode of this application adopts the following technical solutions:

The present application provides an ablation system, including a first catheter and a second catheter. The first conduit includes a flow channel and an expandable member, the flow channel includes a first fluid channel and a second fluid channel isolated from each other; the expandable member is sleeved on the flow channel, the first fluid The channel is used to provide a first fluid to the expandable member to expand the expandable member; the second fluid channel is used to provide a second fluid for ablation to the target tissue area; the second catheter is passed through In the flow conduit, the second conduit is exposed from the distal end of the flow conduit for potential mapping.

In the ablation system provided by the present application, when the second fluid is provided through the second fluid channel of the first catheter to ablate the target tissue area, the distal end of the second catheter can perform potential mapping at the same time, which realizes centering during the ablation process. Real-time monitoring of the internal potential, and can judge the ablation effect according to the real-time monitoring of the intracardiac potential, so as to achieve a good therapeutic purpose. When it is judged that the ablation effect is not good according to the intracardiac potential, re-ablation can be performed directly through the first catheter, and potential mapping can be performed synchronously through the distal end of the second catheter. Compared with related schemes where ablation and mapping can only be performed separately (correspondingly, catheters for ablation or mapping need to be fed into and withdrawn from the body separately), the ablation system provided by this application can perform intracardiac potential while ablation The measurement greatly simplifies the operation steps, shortens the operation time, can perform ablation treatment quickly, and can judge the ablation effect according to the monitored intracardiac potential, guarantees the ablation effect, and can achieve a good therapeutic purpose.

Description of drawings

In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings that need to be used in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only These are some implementations of the present application. For those skilled in the art, other drawings can also be obtained according to these drawings without creative work.

Fig. 1 is a schematic diagram of an ablation system provided in the first embodiment of the present application.

FIG. 2 is a schematic diagram of removing a second catheter by the ablation system shown in FIG. 1 .

Fig. 3 is a schematic cross-sectional view of the inner tube and the outer tube of the flow channel.

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

FIG. 5 is an enlarged schematic diagram of a local area of FIG. 4 .

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

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

Fig. 8 is a schematic diagram of the assembly of the second pipe body, the sealing gasket, the tail cap and the second conduit.

Figure 9 is a schematic diagram of a second catheter.

Fig. 10, Fig. 11 and Fig. 12 are schematic diagrams of possible structures of the bearing part in some other embodiments.

Fig. 13 is a schematic diagram of an ablation system provided in the second embodiment of the present application.

FIG. 14 is a schematic diagram of removing the second catheter by the ablation system shown in FIG. 13 .

FIG. 15 is an enlarged schematic diagram of a partial area of the ablation system shown in FIG. 14 .

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

Fig. 17 is a schematic diagram of the assembly of the connecting pipe and the inner pipe in one embodiment of the present application.

Fig. 18 is a schematic diagram of an ablation system provided in the third embodiment of the present application.

Fig. 19 is a schematic diagram of removing the second catheter by the ablation system shown in Fig. 18 .

FIG. 20 is an enlarged schematic diagram of a partial area of the ablation system shown in FIG. 19 .

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

Fig. 22 is a schematic diagram of an ablation system provided in a fourth embodiment of the present application.

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

Fig. 24 is a schematic diagram of an ablation system provided in a fifth embodiment of the present application.

FIG. 25 is an enlarged schematic diagram of a partial area of the ablation system shown in FIG. 24 .

Fig. 26 is a schematic diagram of an ablation system provided in the sixth embodiment of the present application.

FIG. 27 is a schematic cross-sectional view of the flow channel of the ablation system shown in FIG. 26 .

FIG. 28 is an enlarged schematic diagram of a partial area of the ablation system shown in FIG. 26 .

FIG. 29 is a schematic diagram of the first catheter of the ablation system shown in FIG. 26 .

Detailed ways

The following will clearly and completely describe the technical solutions in the embodiments of the application with reference to the accompanying drawings in the embodiments of the application. Apparently, the described embodiments are only part of the embodiments of the application, not all of them. Based on the implementation manners in this application, all other implementation manners obtained by persons of ordinary skill in the art without creative efforts shall fall within the scope of protection of this application.

The following descriptions of the various embodiments refer to the accompanying drawings to illustrate specific embodiments in which the invention may be practiced. The directional terms mentioned in the present invention, for example, "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., only is to refer to the direction of the attached drawings. Therefore, the direction terms used are for better and more clearly explaining and understanding the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, use a specific orientation construction and operation, therefore, should not be construed as limiting the invention.

In addition, the serial numbers assigned to components herein, such as "first", "second", etc., are only used to distinguish the described objects, and do not have any sequence or technical meaning. The "connection" and "connection" mentioned in this application all include direct and indirect connection (connection) unless otherwise specified.

In the field of interventional medical device technology, the orientation close to the operator is generally defined as the proximal end, and the orientation away from the operator is defined as the distal end; the direction of the rotation center axis of objects such as cylinders and tubes is defined as the axial direction, A direction perpendicular to the axial direction is defined as a radial direction. These definitions are only for the convenience of expression and do not constitute a limitation to the present application.

Please refer to FIG. 1 and FIG. 2. The first embodiment of the present application provides an ablation system 100A, which is used to ablate the target tissue area by means of chemical ablation therapy to achieve the effect of electrical isolation, and can perform cardiac ablation at the same time. Internal potential measurement. The target tissue area can be located in the heart, including but not limited to the vein of Marshall. It can be understood that the target tissue area is not limited to be located on the heart, but may also be located on other body tissues, which is not limited here.

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 catheter 10 includes a flow conduit 11 and an expandable member 13 . Please refer to FIG. 3 , the flow channel 11 includes a first fluid channel 111 and a second fluid channel 113 which are isolated from each other. The expandable member 13 is sheathed on the flow channel 11 . The first fluid channel 111 is used to provide the first fluid to the expandable member 13 to expand the expandable member 13 to achieve occlusion of blood vessels. The second fluid channel 113 is used to provide a second fluid for ablation to the target tissue area. The second conduit 30 is passed through the flow conduit 11 , and the second conduit 30 is exposed from the distal end of the flow conduit 11 for potential mapping.

When the ablation system 100A provides the second fluid through the second fluid channel 113 of the first catheter 10 to ablate the target tissue area, the distal end of the second catheter 30 can simultaneously perform potential mapping. Real-time monitoring of intracardiac potential, and can judge the ablation effect according to the real-time monitoring of intracardiac potential, so as to achieve the purpose of good treatment. On the other hand, the ablation system 100A in this embodiment can perform intracardiac potential Measurement does not require separate operations for ablation and mapping, which greatly simplifies the operation steps and shortens the operation time.

The flow channel 11 includes an inner tube 114 and an outer tube 115 . The inner tube 114 passes through the outer tube 115 . The outer wall of the inner tube 114 and the inner wall of the outer tube 113 jointly 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 passage 113 . The second conduit 30 passes through the second fluid channel 113 . The proximal end of the second conduit 30 exposes the proximal end of the inner tube 114 , and the distal end of the second conduit 30 exposes the distal end of the inner tube 114 . The expandable member 13 is sheathed on the inner tube 114 , and the proximal end of the expandable member 13 is fixedly connected with the distal end of the outer tube 115 and communicated with the first fluid channel 111 .

The inner tube 114 and the outer tube 115 are arranged coaxially, and the distal end of the inner tube 114 exposes the distal end of the outer tube 115 . The inner tube 114 and the outer tube 115 are made of nylon (polyamide, PA). It can be understood that, in other embodiments, the inner tube 114 and the outer tube 115 may not be arranged coaxially, and the application does not limit the materials of the inner tube 114 and the outer tube 115 .

In this embodiment, the inner diameter of the inner tube 114 ranges from 0.55 mm to 1.40 mm, and the inner diameter of the outer tube 115 ranges from 0.85 mm to 1.70 mm. For example, the inner diameter of the inner tube 114 is 0.70 mm, and the inner diameter of the outer tube 115 is 1.20 mm. . It can be understood that the application does not limit the inner diameter range of the inner tube 114 , and the application does not limit the inner diameter range of the outer tube 115 .

Further, optionally, the expandable member 13 includes a first expandable part 131 and a second expandable part 133 arranged along the axial direction of the flow channel 11 . The first expandable part 131 is fixedly connected with the second expandable part 133 . The first expandable member 131 and the second expandable member 133 are arranged in series along the axial direction of the flow channel 11 to improve the effect of the expandable member 13 on blood vessel occlusion.

Specifically, the first expandable element 131 has a first cavity 1310 (as shown in FIG. 4 ), and the second expandable element 133 has a second cavity 1330 (as shown in FIG. 4 ). The first cavity 1310 communicates with the second cavity 1330 , and the second cavity 1330 communicates with the first fluid channel 111 . In other words, the first fluid channel 111 is used to input the first fluid into the first cavity 1310 and the second cavity 1330 . The distal end of the inner tube 114 passes through the second cavity 1330 of the second expandable element 133 and the first cavity 1310 of the first expandable element 131 in turn. The distal end of the outer tube 115 is fixedly connected to the proximal end of the second expandable member 133 .

In this embodiment, the first expandable member 131 is roughly in the shape of a balloon, and the second expandable member 133 is roughly in the shape of a balloon. The distance between the center of the first expandable part 131 and the center of the second expandable part 133 ranges from 4 mm to 12 mm, for example, the distance between the center of the first expandable part 131 and the center of the second expandable part 133 is 6mm. Optionally, both the first inflatable member 131 and the second inflatable member 133 are semi-compliant balloons, so as to improve the sealing effect of the balloons. Semi-compliant balloons have a wide working range, can flexibly manipulate the size of the balloon, and are mostly used for pre-dilation. The material of the first expandable member 131 and the second expandable member 133 includes one of polyether block amide (polyether block amide, PEBAX), PA, thermoplastic polyurethane elastomer rubber (thermoplastic polyurethanes, TPU). It can be understood that the present application does not limit the materials of the first expandable element 131 and the second expandable element 133 .

The expandable member 13 includes an expanded state and a non-expanded state. The expandable member 13 is expanded by the first fluid provided by the first fluid channel 111 to be able to occlude the blood vessel. The volume of the expandable member 13 in the expanded state is larger than the volume of the expandable member 13 in the non-expanded state. In the expanded state, the shape of the first expandable part 131 and the shape of the second expandable part 133 may be a hollow cylindrical shape as shown in FIG. 4 . As shown in FIG. 4 , the axial length of the first expandable element 131 is greater than the maximum outer diameter of the first expandable element 131 , and the axial length of the second expandable element 133 is greater than the maximum outer diameter of the second expandable element 133 .

It can be understood that the present application does not limit the shape of the first expandable member 131 , for example, it may be heart-shaped, square, spherical and so on. The present application does not limit the shape of the second expandable member 133 , for example, it may be heart-shaped, square, spherical and so on.

Please refer to FIG. 5 and FIG. 6 , the expandable member 13 further includes a connecting pipe 135 outside the flow channel 11 for connecting the first expandable part 131 and the second expandable part 133 . The distal end of the connecting tube 135 is fixedly connected to the proximal end of the first expandable element 131 , and the proximal end of the connecting tube 135 is fixedly connected to the distal end of the second expandable element 133 . The connecting tube 135 has a lumen 1350 , and the lumen 1350 communicates with the first cavity 1310 and the second cavity 1330 , so that the first fluid input into the second cavity 1330 enters the first cavity 1310 through the lumen 1350 . The distal end of the inner tube 114 also passes 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 can be understood that the present application does not limit the fixed connection method between the connecting pipe 135 and the first expandable member 131 , and the present application does not limit the fixed connection method between the connecting pipe 135 and the second expandable member 133 .

In this embodiment, the axial length of the connecting pipe 135 is not less than 6 mm, the inner diameter of the connecting pipe 135 is approximately the same as the outer diameter of the distal end of the outer pipe 115 , and the material of the connecting pipe 135 is the same as that of the outer pipe 115 . It can be understood that the present application does not limit the length of the connecting pipe 135 , and the present application does not limit the outer diameter and material of the connecting pipe 135 .

Further, in one embodiment, a breach 1351 is provided on the tube wall of the connecting tube 135 to expose part of the inner tube 114 . The breach 1351 is roughly rectangular. It can be understood that the present application does not specifically limit the shape of the opening 1351 , for example, it may be circular, oval, rectangular, or irregular. The flow pipe 11 passes through the side wall of the inner tube 114 to define an injection through hole 119 for injecting the second fluid, and the position of the injection through hole 119 corresponds to the position of the breach 1351 . The injection through hole 119 is substantially circular. The inner wall of the lumen 1350 includes a first sealing area 1353 disposed around the periphery of the breach 1351 . The flow pipe 11 is provided with a second sealing area 1133 around the injection hole 119 . The first sealing area 1353 is in sealing connection with the second sealing area 1133 to ensure the sealing connection between the edge of the opening 1351 and the inner tube 114 . The first sealing area 1353 and the second sealing area 1133 can be hermetically connected by heat fusion or the like.

The expandable member 13 adopts a series-type double-balloon structure. When the target tissue area is ablated, since the distal end of the inner tube 114 can inject the second fluid to the distal end of the target tissue area, the injection through hole 119 can ablate the target tissue area. The middle section and the proximal section of the tissue area spray the second fluid, therefore, it is not necessary to perform operations such as expansion, contraction, and retraction on the expandable member 13 multiple times to complete the treatment of the distal section, the middle section, and the proximal section of the target tissue area. Injection of the fluid, only one expansion and contraction of the expandable member 13 is required to complete the injection and ablation of the second fluid to the entire target tissue area. It can be seen that after the inflatable member 13 adopts a series-type double-balloon structure, it can not only achieve simultaneous ablation and mapping, but also complete the ablation of the entire target tissue area with only one operation, which further simplifies the operation to a greater extent. The steps shorten the operation time and can realize rapid ablation treatment.

Please refer to FIG. 4 again, the first conduit 10 further includes a first developing object 141 and a second developing object 143 . The first developing object 141 is located at the position of the inner tube 114 corresponding to the first expandable member 131 , so as to mark the position of the first expandable member 131 when the ablation system 100A performs an operation. The second developing object 143 is located at the position of the inner tube 114 corresponding to the second expandable member 133, so as to mark the position of the second expandable member 133 when the ablation system 100A performs an operation. Both the first developing object 141 and the second developing object 143 are made of X-ray opaque material.

In this embodiment, each of the first developing object 141 and the second developing object 143 is arranged on the outer wall of the inner tube 114 and arranged around the circumference of the inner tube 114 to form a ring-shaped developing structure. The first developing object 141 is roughly Set in the middle of the first expandable part 131, the second developing object 143 is roughly arranged in the middle of the second expandable part 133, so that the operation process can be determined through the development of the first developing object 141 and the second developing object 143 The position of the inflatable member, and the two developers are arranged in a ring around the inner tube 114 to improve the developing effect.

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

Please refer to FIG. 1 , FIG. 2 and FIG. 7 in conjunction, 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. For example, the head end 15 is generally in the shape of a truncated cone to improve the tracking of the first catheter 10, and the first catheter 10 enters the blood vessel smoothness. The head end 15 includes a hollow cavity 150 in communication with the second fluid passage 113 . The second catheter 30 passes through the head end 15 and emerges from the distal end of the head end 15 .

In this embodiment, the hardness of the head end 15 is greater than the hardness of the inner tube 114, so as to improve the smoothness of the first catheter 10 entering narrow blood vessels. The axial length of the head end 15 ranges from 1 mm to 3 mm, for example, the axial length of the head end 15 is 2 mm. It can be understood that the present application does not limit the hardness and axial length of the head end 15 .

Since the short and hard tip 15 can make the first catheter 10 easier to enter the narrow vein of Marshall, but it may also cause damage to the blood vessel, therefore, optionally, in one embodiment, the first catheter 10 can It includes a protective layer (not shown) coated on the outer wall of the head end 15 . The material of the protective layer is relatively soft, so as to reduce the damage to the blood vessel when the head end 15 enters the blood vessel. In this embodiment, the material of the protective layer includes but is not limited to polytetrafluoroethylene (polytetrafluoroethylene, PTFE).

Optionally, the distal peripheral wall of the head end 15 is provided with an injection port 151 communicating with the hollow cavity 150 of the head end 15 . The injection port 151 is used to inject the second fluid. The hollow cavity 150 and the injection port 151 can inject the second fluid at the same time, so as to increase the injection area of the second fluid, thereby improving the ablation efficiency. The number of injection ports 151 may be one or more. When the number of injection ports 151 is more than one, 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 to limit the head end 15 when mating with the inner tube 114 , so as to increase the connection stability between the head end 15 and the inner tube 114 . Please refer to FIG. 1 and FIG. 2 again, the first conduit 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 channel 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 channel 11 is fixedly connected to the distal end of the second connector 17 , and the second connector 17 is used to provide the second fluid to the second fluid channel 113 .

More specifically, the first connector 16 includes a first tube body 161 and a first injection tube 163 that are fixedly connected. The first pipe body 161 is connected with the first injection pipe 163 to form a Y-shaped structure. The first injection pipe 163 has a first fluid injection port 1631 . Both the outer tube 115 and the inner tube 114 of the circulation channel 11 pass through the first tube body 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 for injecting the first fluid into the first tube body 161 and flowing into the first fluid channel 111 through the first injection tube 163 to inflate the expandable member 13 . The proximal end of the first tube body 161 can be fixedly connected with the inner tube 114 passing through the first tube body 161 through glue or injection molding to reduce the possibility of relative movement between the first tube body 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 includes but is not limited to 100mm-200mm.

The second connector 17 includes a second tube body 171 and a second injection tube 173 that are fixedly connected. The second pipe body 171 is connected with the second injection pipe 173 to form a Y-shaped structure. The second injection pipe 173 has a second fluid injection port 1731 . The distal end of the second tube body 171 is fixedly connected with the proximal end of the inner tube 114 of the flow channel 11 . The second tube body 171 communicates with the second fluid channel 113 . The second fluid injection port 1731 is used for injecting the first fluid into the second tube body 171 and flowing into the second fluid channel 113 through the second injection tube 173 . The proximal end of the second tube body 171 can be fixedly connected with the inner tube 114 passing through the second tube body 171 through glue or injection molding to reduce the possibility of relative movement between the second tube body 171 and the inner tube 114 .

Please refer to FIG. 1 and FIG. 8 , the second tube body 171 includes a first insertion hole 1711 arranged along the axial direction of the second tube body 171 , and the proximal end surface of the second tube body 171 is provided to communicate with the first insertion hole 1711 Flaring 1713. The first conduit 10 also includes a gasket 18 . The gasket 18 is accommodated in the flaring opening 1713 and sealed with the second tube body 171 to prevent blood and the second fluid from overflowing. The outer diameter of the gasket 18 may be slightly larger than the diameter of the flaring 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 conduit 30 passes through the first insertion hole 1711 and the second insertion hole 181 .

Optionally, the first catheter 10 further includes a tail cap 19 fixedly connected to the proximal end of the second tube body 171 . In this embodiment, the outer wall of the second pipe body 171 is provided with an external thread 1715, and the tail cap 19 is provided with an internal thread (not shown) adapted to the external thread 1715, and the second pipe body 171 is screwed to the tail cap 19. . It can be understood that the present application does not limit the connection method between the second pipe body 171 and the tail cap 19 . The gasket 18 is fixedly accommodated in the tail cap 19 . The proximal end of the tail cap 19 is provided with a conduit hole 191 . The second conduit 30 passes through the conduit hole 191 .

Please refer 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 with the proximal end of the flexible tube 32 . The proximal end of the metal shaft tube 31 is fixedly connected with the electrical connector 35 .

The distal end of the flexible tube 32 emerges from the distal end of the inner tube 114 of the flow conduit 11 . In this embodiment, the material of the flexible tube 32 includes but is not limited to a resin material, for example, the resin material includes thermoplastic polyurethane elastomer rubber (thermoplastic polyurethanes, TPU) or pebax. The proximal end of the flexible tube 32 is provided with a flaring structure (not shown in the figure) to facilitate the insertion of the metal shaft tube 31 , thereby facilitating the 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 flaring structure of the flexible tube 32 and bonded with glue, and the proximal end of the metal shaft tube 31 is connected to the electrical connector 35 through glue bonding. . The material of the metal shaft tube 31 is not specifically limited, and may be metal materials such as stainless steel and nickel-titanium alloy. The inner diameter of the flexible tube 32 may range from 0.25 mm to 1.2 mm, for example, the inner diameter of the flexible tube 32 may be 0.35 mm. It can be understood that the connection method between the metal shaft tube 31 and the flexible tube 32 is not limited to bonding, for example, it may also be snap-fitting or the like.

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

The electrode 33 is disposed at the distal end of the flexible tube 32 and is electrically connected to the electrical connector 35 for potential mapping. The electrodes 33 include ring electrodes 331 and head electrodes 333 . Both the ring electrode 331 and the head electrode 333 are used for potential mapping. The ring electrode 331 is sheathed on the bearing portion 321 of the flexible tube 32 and is electrically connected to the electrical connector 35 through the wire 37 . In this embodiment, there are multiple ring electrodes 331 , and the multiple ring electrodes 331 are arranged along the axial direction of the flexible tube 32 . Each ring electrode 331 is connected to the electrical connector 35 through a wire 37 so as to be able to control the voltage applied to the ring electrodes 331 respectively. The wire 37 includes, but is not limited to, an enameled copper wire. The head electrode 333 is fixed on the farthest end of the flexible tube 32 , and the head electrode 333 is electrically connected to the electrical connector 35 through a wire 37 . The wire 37 is connected to the ring electrode 331 and the head electrode 333 by welding or other connection methods.

It can be understood that, in other implementation manners, the electrode 33 may omit the head electrode 333 and perform potential mapping through the ring electrode 331 .

It should be noted that, in a possible implementation manner, the electrode 33 may also be configured to generate a pulse electric field for pulse ablation of the target tissue region. Pulse ablation uses a high-intensity pulsed electric field to cause irreversible electrical breakdown of the cell membrane, which is called irreversible electroporation (IRE) in the medical field, to cause cell apoptosis to achieve non-thermal ablation of cells, so it is not affected by the heat sink effect. The high-voltage pulse sequence produces less heat and does not need saline irrigation for cooling, which can effectively reduce the occurrence of gas explosion, eschar and thrombus. The pulse ablation treatment time is short, the treatment time of applying a set of pulse sequences is less than 1 minute, and the whole ablation time is generally no more than 5 minutes. And because different tissues have different response thresholds to pulsed electric fields, it is possible to ablate the myocardium without disturbing other adjacent tissues, thereby avoiding accidental injury to adjacent tissues. In addition, compared with other energies, pulse ablation does not require heat conduction to ablate deep tissues, and all cardiomyocytes distributed above a certain electric field strength will undergo electroporation, which reduces the pressure requirements for catheter abutment during ablation. Therefore, even if the ablation device does not completely adhere to the inner wall of the tissue, the ablation effect of IRE will not be affected.

While high voltage pulses may be selected as the form of energy delivered through electrodes 33, other forms of energy may additionally or alternatively be delivered, such as radio frequency energy or any other suitable form of energy. That is, the electrodes 33 may also be configured to transmit radiofrequency energy or other suitable forms of energy (eg, microwaves) to perform ablation treatment on the target tissue region.

The supporting wire 34 passes through the flexible tube 32 for supporting the flexible tube 32 . The support wire 34 includes a small diameter portion (not shown) located at the distal end of the support wire 34 and a large diameter portion (not shown) located at the proximal end of the support wire 34 . The outer diameter of the large-diameter portion is greater than that of the small-diameter portion, and the small-diameter portion passes through the bearing portion 321 and the connecting portion 323 of the flexible tube 32 . The support wire 34 includes but is not limited to nickel-titanium alloy. The support wire 34 has superelasticity and memory properties, and plays a supporting role to ensure the rigidity of the distal end of the second catheter 30 . Since the distal end of the support wire 34 is thinner and the proximal end is thicker, the distal end of the second catheter 30 has rigidity and flexibility at the same time, thereby reducing damage to blood vessels caused by the second catheter 30 during surgery. The diameter of the support wire 34 ranges from 0.10 mm to 0.40 mm, for example, the diameter of the support wire 34 is 0.18 mm.

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

In some possible implementations, as shown in FIG. 10 , the bearing part 321 includes a helical structure 3213, the helical structure 3213 extends helically along the axial direction of the connecting part 323, the ring electrode 331 is arranged on the helical structure 3213, and the head electrode 333 is arranged on the At the farthest end of the bearing part 321, the radial dimension of the helical structure is equivalent to the diameter of the blood vessel. In this way, the ring electrode 331 on the bearing part 321 can be better attached to the blood vessel wall, which is beneficial to improve the heart rate. The accuracy of the internal potential measurement. The radial dimension of the helical structure refers to the dimension in the direction perpendicular to the axial direction of the helical structure.

Since the vein of Marshall is a branch of the coronary sinus, it is difficult to accurately enter the traditional straight catheter. In some possible implementations, as shown in FIG. 11 , the carrying portion 321 includes a curved structure 3215 , and the curved structure 3215 is disposed at the farthest end of the carrying portion 321 and is bent relative to the axial direction of the connecting portion 323 . The bending angle range of the curved structure 3215 relative to the axial direction of the connecting portion 323 or the axial direction of the first conduit is not less than 90° and not greater than 150°, that is, the bending angle range of the curved structure 3215 relative to the axis of the connecting portion 323 is [90°,150°]. The angle between the vein of Marshall and the coronary sinus is approximately 90° to 150°. Since the bending angle of the curved structure 3215 relative to the axis of the connecting portion 323 is approximately the same as the angle between the vein of Marshall and the coronary sinus, in this way, the second catheter 30 can enter the blood vessel well without greatly Increase manufacturing cost.

In some possible implementations, as shown in FIG. 12 , the bearing part 321 includes a helical structure 3213 and a curved structure 3215, the helical structure 3213 extends helically along the axial direction of the connecting part 323, and the ring electrode 331 is disposed on the helical structure 3213. The head electrode 333 is disposed at the farthest end of the bearing portion 321 , and the curved structure 3215 is disposed at the farthest end of the bearing portion 321 and bent relative to the axial direction of the connecting portion 323 . The bearing part 321 combines the helical structure 3213 and the curved structure 3215, wherein the helical structure 3213 can make the ring electrode 331 on the bearing part 321 and the blood vessel wall can be better attached to, thereby helping to improve the accuracy of intracardiac potential measurement . The bending angle range of the curved structure 3215 relative to the axial direction of the connecting portion 323 or the axial direction of the first conduit is not less than 90° and not greater than 150°, that is, the bending angle range of the curved structure 3215 relative to the axis of the connecting portion 323 is [90°,150°]. The angle between the vein of Marshall and the coronary sinus is approximately 90° to 150°. Since the bending angle of the curved structure 3215 relative to the axis of the connecting portion 323 is approximately the same as the angle between the vein of Marshall and the coronary sinus, in this way, the second catheter 30 can enter the blood vessel well without greatly Increase manufacturing cost.

Taking the target tissue region as the human heart as an example, the operation steps of the ablation system 100A provided in the first embodiment for operating the human heart will be briefly described. Wherein, the first fluid includes gas or liquid, and the second fluid is absolute ethanol. It can be understood that the present application does not limit the target tissue area to the human heart, for example, the lungs, kidneys or other target tissue areas of the living body.

(1) Insertion of the sheath

Under local anesthesia, the right femoral vein or subclavian vein is punctured, and the sheath is sent to the coronary sinus ostium of the right atrium through the inferior vena cava or superior vena cava.

(2) Guide catheter insertion

After confirming the existence of Marshall's vein through the contrast catheter, insert the guide catheter into the lumen of the sheath, and make the guide catheter located at the opening of Marshall's vein.

(3) Insertion of the second catheter 30

Send the second catheter 30 , which can be used instead of the guide wire, to the distal end of the Marshall vein along the lumen of the guiding catheter, and perform potential measurement.

(4) Insertion of the first catheter 10

Send the first catheter 10 along the second catheter 30 to the distal end of the vein of Marshall, and then adjust the position of the expandable member 13 so that the second expandable member 133 is placed at the proximal end of the vein of Marshall, and the first expandable member 131 is placed in the vein of Marshall remote.

(5) Expandable member 13 expansion and ethanol injection ablation

Inject the first fluid from the first fluid injection port 1631 of the first connector 16 into the expandable member 13, so that the expandable member 13 expands. 1731 Slowly inject the second fluid (4-6ml of ethanol, usually 1ml/1min), and the second fluid is sprayed out along the second fluid channel 113 of the first catheter 10; after 2 minutes of observation, inject the second fluid. A total of 2-3 bolus injections are performed, and the total bolus injection volume of the second fluid does not exceed 12ml.

(6) Potential measurement

With the first catheter 10 held proximal to the vein of Marshall, the second catheter 30 is used to perform potential measurements on the vein of Marshall. The ablation effect is judged according to the measurement results. When the ablation is unsuccessful, there is no need to withdraw the second catheter 30 , and the first catheter 10 can be directly used for re-ablation. After the ablation is completed, the second catheter 30 is retracted to the first catheter 10, and then the first catheter 10 and the second catheter 30 are retracted together to guide the catheter and the sheath to complete sheath retraction.

The ablation system 100A provided in this embodiment can measure the potential during ablation, monitor the intracardiac potential in real time and judge its ablation effect, which simplifies the ablation procedure, shortens the operation time, and improves the ablation efficiency.

Please refer to FIG. 13 and FIG. 14 , an ablation system 100B provided in the second embodiment of the present application has substantially the same structure as the ablation system 100A provided in the first embodiment, except that the connecting tube 135 is located outside the flow channel 11 .

More specifically, referring to FIG. 15 , the distal end of the flow channel 11 includes a first area 116 , a second area 117 and a third area 118 arranged along the axial direction of the flow channel 11 , and the second area 117 is located between the first area 116 and the third area 118 . Between the third area 118 . The first expandable element 131 is located in the first area 116 , and the second expandable element 133 is located in the third area 118 . Please refer to FIG. 16 , the second area 117 includes a first setting area 1171 and a second setting area 1173 . The first setting area 1171 is used for setting the connecting pipe 135 . In this embodiment, the circulation channel 11 includes an inner tube 114 and an outer tube 115 sleeved outside the inner tube 114 . The distal end of the inner tube 114 emerges from the distal end of the outer tube 115 .

The connection tube 135 has a lumen 1350 . There are multiple connecting pipes 135 , and the multiple connecting pipes 135 are located in the first setting area 1171 of the second area 117 . A plurality of connecting tubes 135 are arranged at intervals along the circumference of the inner tube 114 exposing the distal end of the outer tube 115 . Along the circumferential direction of the flow pipe 11 , a gap 1353 is formed between two adjacent connecting pipes 135 corresponding to the second installation area 1173 . The inner tube 114 is located outside the lumen 1350 of the connecting tube 135 . The inner tube 114 passes through the first cavity of the first expandable component 131 and the second cavity of the second expandable component 131 .

The sidewall of the inner tube 114 is provided with an injection through hole 119 for injecting the second fluid. The injection through hole 119 is located in the second setting area 1173 . The spraying holes 119 are arranged corresponding to the positions of the gaps 1353 .

The application does not limit the cross-sectional shape of the connecting pipe 135 , for example, the cross-section of the connecting pipe 135 may be circular as shown in FIG. 17 , or may be fan-shaped. As another example, in some embodiments, referring to FIG. 17 , the cross section of the connecting pipe 135 is substantially flat, and the connecting pipe 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 both the first side wall 1335 and the third side wall 1357 are arc-shaped walls. The first side wall 1355 coincides with the outer wall of the inner tube 114 , so that the first side wall 1355 and the outer wall of the inner tube 114 can fit together well. It can be understood that, in some embodiments, at least part of the outer wall of the connecting tube 135 coincides with the outer wall of the inner tube 114 , so that the connecting tube 135 and the inner tube 114 can be better attached together.

It can be understood that the present application does not limit the structure of the flow pipe 11. For example, the flow pipe 11 can be a multi-lumen pipe, and the flow pipe 11 only needs to have a first fluid channel and a second fluid channel. In other embodiments, the connecting pipe 135 The number can be at least one, the connecting tube 135 is at least located in the second region 117 and the flow channel 11 is located outside the lumen 1350 of all the connecting tubes 135, and the flow channel 11 is passed through the first cavity and the second cavity of the first expandable member 131. The second bladder of the expandable member 133 .

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

In the ablation system 100B provided in the second embodiment, the first expandable member 131 and the second expandable member 133 are connected through at least one connecting tube 135, so that the structural section of the flow channel 11 provided with the injection through hole 119 does not need to be connected with the connecting tube 135. The sealing process, in this way, facilitates the construction and manufacture of the ablation system 100B.

Please refer to FIG. 18 and FIG. 19 , an ablation system 100C provided in the third embodiment of the present application has substantially the same structure as the ablation system 100A provided in the first embodiment, except that the first catheter 10 omits the connecting tube 135 .

More specifically, please refer to FIG. 20 and FIG. 21 in conjunction. The distal end of the flow channel 11 includes a first area 116 , a second area 117 and a third area 118 arranged along the axial direction of the flow channel 11 . The second area 117 is located between the first area 116 and the third area 118 . The first expandable element 131 is located in the first area 116 , and the second expandable element 133 is located in the third area 118 . The second area 117 includes a first setting area 1171 and a second setting area 1173 .

The expandable member 13 further includes an air guiding portion 137 covering the first setting area 1171 for communicating with the first expandable part 131 and the second expandable part 133 . The distal end of the air guide part 137 is fixedly connected to the proximal end of the first expandable part 131 , and the proximal end of the air guide part 137 is fixedly connected to the distal end of the second expandable part 133 . The air guide part 137 has an air guide channel 1371 communicating with the first cavity of the first expansion part 131 and the second cavity of the second expansion part 133 . The second installation area 1173 is exposed outside the air guiding part 137 . The inner tube 114 passes through the side wall of the second fluid passage 113 to form an injection hole 119 for injecting the second fluid in the second installation area 1173 . The distance between the injection through hole 119 and the center of the first expandable part 131 is roughly half of the distance between the center of the first expandable part 131 and the center of the second expandable part 133 .

In this embodiment, the first expandable part 131 and the second expandable part 133 are integrally formed, and since there is no connecting pipe, the structure is simple and the manufacturing process is simple.

It can be understood that the structure of the flow pipe 11 is not limited. For example, when the flow pipe 11 is a multi-lumen pipe, the side wall of the second fluid channel 113 of the flow pipe 11 forms an injection channel for spraying the second fluid in the second setting area 1173. Hole 119.

Please refer to FIG. 22 and FIG. 23 , an ablation system 100D provided by the fourth embodiment of the present application is substantially the same in structure as the ablation system 100A provided by the first embodiment, except that the flow channel 11 is a multi-lumen channel.

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

In this embodiment, the cross-sectional shape of the circulation channel 11 is approximately circular, and the cross-sectional shape of the storage cavity 121 is approximately circular. The receiving cavity 121 is located between the first fluid channel 111 and the second fluid channel 113, the sectional area of the receiving cavity 121 is larger than the sectional area of the first fluid channel 111, the sectional area of the receiving cavity 121 is larger than the sectional area of the second fluid channel 113, So that the movement space of the second conduit 30 in the receiving cavity 121 is sufficient.

Since the second conduit 30 is installed in the independent accommodation cavity 121, when the second conduit 30 moves relative to the flow conduit 11, it will not be disturbed by the second fluid, which is beneficial to improve the smoothness of the movement of the second conduit 30 relative to the flow conduit 11 .

It can be understood that the present application does not limit the cross-sectional shape of the circulation channel 11 , the cross-sectional shape of the receiving chamber 121 , the cross-sectional shape of the first fluid channel 111 , and the cross-sectional shape of the second fluid channel 113 .

Please refer to FIG. 24 and FIG. 25 , an ablation system 100E provided by the fifth embodiment of the present application is substantially the same in structure as the ablation system 100A provided by the first embodiment, and the expandable member 13 also includes a third expandable member 139 , the first The three expandable elements 139 have a third cavity 1390 , and the third cavity 1390 communicates with the first cavity 1310 and the second cavity 1330 .

In the fifth embodiment, the proximal end of the first expandable element 131 and the distal end of the second expandable element 133 are connected and communicated through a connecting tube 135, and the proximal end of the second expandable element 133 is connected to the third expandable element. The distal end of the third expandable element 139 is connected and communicated with by a connecting tube 135 , and the proximal end of the third expandable element 139 is fixedly connected with the distal end of the outer tube 115 .

The connecting tube 135 between the proximal end of the first expandable part 131 and the distal end of the second expandable part 133, the connecting tube between the distal end of the second expandable part 133 and the distal end of the third expandable part 139 135 are provided with breaches 1351, the inner tube 114 runs through the side wall of the second fluid passage 113 and is provided with injection through holes 119 for injecting the second fluid, and the positions of the injection through holes 119 correspond to the positions of the breaches 1351.

The inner wall of the lumen of the connecting tube 135 includes a first sealing area, and the first sealing area is arranged around the periphery of the opening 1351 . The flow pipe 11 is provided with a second sealing area around the injection through hole 119 . The first sealing area is in sealing connection with the second sealing area, so as to ensure the sealing connection between the edge of the opening 1351 and the inner tube 114 . The first sealing area and the second sealing area may be sealed and connected by heat fusion or the like, so that the edge of the breach 1351 is sealed and connected with the inner tube 114 .

The ablation system 100E provided by the fifth embodiment of the present application has three expandable components to adapt to organisms with relatively long blood vessels. For example, because some patients may have longer veins of Marshall, two expandable components cannot achieve one-time occlusion and ablation, and three expandable components with longer lengths can effectively occlude.

It can be understood that the structure of the flow channel 11 is not limited. For example, when the flow channel 11 is a multi-lumen channel, the expandable member 13 of multi-expansion element type is also applicable.

It can be understood that the present application does not limit the position of the third expandable part 139 , for example, the third expandable part 139 may be connected between the first expandable part 131 and the second expandable part 133 .

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

Please refer to FIG. 26 , an ablation system 100F provided in the sixth embodiment of the present application is substantially the same in structure as the ablation system 100A provided in the first embodiment, except that the structure of the first catheter 10 is different.

The ablation system 100F includes a first catheter 10 and a second catheter 30 . The first catheter 10 is used to ablate a target tissue region. The first catheter 10 includes a flow conduit 11 and an expandable member 13 . Please refer to FIG. 27 , the flow channel 11 includes a first fluid channel 111 and a second fluid channel 113 which are isolated from each other. The expandable member 13 is sheathed on the flow channel 11 . The first fluid channel 111 is used to provide the first fluid to the expandable member 13 to expand the expandable member 13 to achieve occlusion of blood vessels. The second fluid channel 113 is used to provide a second fluid for ablation to the target tissue area. The second conduit 30 is passed through the flow conduit 11 , and the second conduit 30 is exposed from the distal end of the flow conduit 11 for potential mapping.

When the ablation system 100F provides the second fluid through the second fluid channel 113 of the first catheter 10 to ablate the target tissue area, the distal end of the second catheter 30 can simultaneously perform potential mapping. Real-time monitoring of intracardiac potential, and can judge the ablation effect according to the real-time monitored intracardiac potential, so as to achieve the purpose of good treatment. On the other hand, the ablation system 100F in this embodiment can perform intracardiac potential while ablation Measurement does not require separate operations for ablation and mapping, which greatly simplifies the operation steps and shortens the operation time.

The specific structure, material, etc. of the inner tube 114 and the specific structure, material, etc. of the outer tube 115 can refer to the first embodiment of the present application.

The expandable member 13 includes a first expandable part 131 and a second expandable part 133 disposed along the axial direction of the flow channel 11 . The first expandable part 131 is fixedly connected with the second expandable part 133 . For the specific structure of the first expandable member 131 and the specific structure of the second expandable member 133 , please refer to the first embodiment of the present application. The first expandable member 131 has a first bladder 1310 , and the second expandable member 133 has a second bladder 1330 . The first cavity 1310 communicates with the second cavity 1330 , and the second cavity 1330 communicates with the first fluid channel 111 . In other words, the first fluid channel 111 is used to input the first fluid into the first cavity 1310 and the second cavity 1330 . The distal end of the inner tube 114 passes through the second cavity 1330 of the second expandable element 133 and the first cavity 1310 of the first expandable element 131 in turn. The distal end of the outer tube 115 is fixedly connected to the proximal end of the second expandable member 133 .

The first expandable part 131 and the second expandable part 133 are integrally arranged, and no connecting pipe is provided between the first expandable part 131 and the second expandable part 133 of the first catheter 10, so as to simplify the structure of the expandable member 13, And the manufacture of the expandable member 13 is facilitated.

Referring to FIG. 28 , the first developing object 141 is located at the position of the inner tube 114 corresponding to the first expandable member 131 , so as to mark the position of the first expandable member 131 when the ablation system 100F performs an operation. The second developing object 143 is located at the position of the inner tube 114 corresponding to the second expandable member 133, so as to mark the position of the second expandable member 133 when the ablation system 100F performs an operation. Both the first developing object 141 and the second developing object 143 are made of X-ray opaque material.

The head end 15 includes a hollow cavity 150 communicating with the second fluid channel 113 for injecting the second fluid. The distal peripheral wall of the head end 15 is not provided with injection ports to simplify the structure of the head end 15 .

Please refer to FIG. 26 and FIG. 29, the first conduit 10 further includes a connector 58, the connector 58 is sleeved on the outer tube 115 and the inner tube 114 of the flow channel 11, for providing the first fluid to the first fluid channel 111 and to the first fluid channel 111. The second fluid channel 113 provides a second fluid. The connector 58 includes a base body 581 , a first injection tube 583 and a second injection tube 585 . The seat body 581 is sheathed on the outer tube 115 . The seat body 581 defines a first installation hole 5810 and a second installation hole 5811 in communication with each other along the axial direction. The first installation hole 5810 runs through the distal end surface of the seat body 581. In this embodiment, the diameter of the first installation hole 5811 is larger than the diameter of the second installation hole 5811 . It can be understood that the diameter of the first installation hole 5811 and the diameter of the second installation hole 5811 may be the same or different. A first dispensing hole 5813 and a second dispensing hole 5814 are disposed on the outer wall of the base body 581 . Compared with the first glue dispensing hole 5813 , the second glue dispensing hole 5814 is closer to the proximal end of the seat body 581 . The first glue dispensing hole 5813 communicates with the first installation hole 5810 , and the second glue dispensing hole 5814 communicates with the second installation hole 5811 .

Both the inner tube 114 and the outer tube 115 pass through the first installation hole 5810 . The proximal end of the inner tube 114 exposes the proximal end of the outer tube 115 and passes through the second installation hole 5811 . In this embodiment, the colloid can be loaded from the first dispensing hole 5813 and the second dispensing hole 5814, so that the proximal end of the outer tube 115 is fixed to the seat body 581, and the proximal end of the inner tube 114 is connected to the seat body 581. phase fixed. It can be understood that the application does not limit the connection method between the seat body 581 and the outer tube 115 , and the application does not make limitations on the connection method between the seat body 581 and the inner tube 114 .

The first injection pipe 583 has a first fluid injection port 5831 for injecting the first fluid into the first fluid channel 111 . The second injection pipe 585 has a second fluid injection port 5851 for injecting the second fluid into the second fluid channel 113 . The first fluid injection port 5831 and the second fluid injection port 5851 are disposed on the same seat body 581 , which can simplify the structure of the connector 58 and facilitate the assembly of the ablation system 100F.

The proximal surface of the base body 581 is further provided with a flaring opening 5817 communicating with the second installation hole 5811 . The first conduit 10 also includes a gasket 58 . The sealing gasket 58 is accommodated in the flared opening 5817 and sealed with the seat body 581 to prevent blood and the second fluid from overflowing. The outer diameter of the gasket 18 can be slightly larger than the diameter of the flaring 5817. The gasket 18 is provided with a second insertion hole 181 . The material of the gasket 18 includes but is not limited to silica gel. The second conduit 30 passes through the second installation hole 5811 and the second insertion hole 181 of the gasket 18 .

Optionally, the first catheter 10 further includes a tail cap 62 fixedly connected to the proximal end of the seat body 581 . The tail cover 62 includes a sleeve portion 621 and a joint portion 623 accommodated in the sleeve portion 621 . A proximal end of the engaging portion 623 is fixedly connected to a proximal end of the sleeve portion 621 . A catheter hole 6210 is formed on the proximal surface of the sheathing portion 621 , and the catheter hole 6210 passes through the proximal surface of the joint portion 623 and the distal surface of the joint portion 623 . The second conduit 30 passes through the conduit hole 6210 .

In this embodiment, an external thread 5819 is provided on the outer wall of the proximal end of the seat body 581, and an internal thread 6213 matching the external thread 5819 is provided on the inner wall of the sleeve part 621. The internal thread 6213 is screwed. The proximal end of the base body 581 is sandwiched between the sleeve portion 621 and the joint portion 623, so that the base body 581 is limited between the sleeve portion 621 and the joint portion 623 and is difficult to move in the radial direction, thereby The stability of the ablation system 100F can be improved.

The connector 58 further includes a sheath 60 sheathed on the distal end of the base body 581 , and the flow channel 11 is passed through the sheath 60 . The sheath 60 is used to protect the flow pipe 11 and improve the strength of the flow pipe 11 to reduce the possibility of the flow pipe 11 being damaged due to bending. In this embodiment, both the inner tube 114 and the outer tube 115 are passed through the sheath 60 .

In this embodiment, the proximal end of the sheath 60 is in interference fit with the seat body 581, and the distal end of the sheath 60 is in clearance fit with the flow channel 11 (such as the outer tube 115). The sheath 60 can be made of silica gel, rubber, TPU, Pebax materials with relatively low hardness. Rubber is preferred for this embodiment.

It can be understood that if the connectors in the ablation system 100F are split, for example, the connectors in the first embodiment of the present application include a first connector and a second connector, and the distal end of the first connector can be sleeved with The sheath, and/or the distal end of the second connector can be covered with a sheath.

It can be understood that the structure of the flow pipe 11 is not limited. For example, when the flow pipe 11 is a multi-lumen pipe, the integrated connector 58 is also applicable, and the flow pipe 11 only needs to have a first fluid channel and a second fluid channel.

It can be understood that, in the case of different conflicts, the first embodiment to the sixth embodiment of the present application can be combined with each other.

What is disclosed above is only a preferred implementation mode of the application, and of course it cannot limit the scope of rights of the application. Therefore, equivalent changes made according to the claims of the application still fall within the scope of the application.

Claims

An ablation system, characterized in that it includes a first catheter and a second catheter, the first catheter includes a flow channel and an expandable member, and the flow channel includes a first fluid channel and a second fluid channel that are isolated from each other; The expandable member is sleeved on the flow channel, the first fluid channel is used to provide the first fluid to the expandable member to expand the expandable member; the second fluid channel is used to supply the target The tissue area provides a second fluid for ablation; the second conduit is passed through the flow channel, and the second conduit is exposed from the distal end of the flow channel for potential mapping.
The ablation system according to claim 1, wherein the expandable member comprises a first expandable part and a second expandable part arranged axially along the flow channel, the first expandable part and the The second expandable element is fixedly connected, the first expandable element has a first cavity, the second expandable element has a second cavity, and the first cavity communicates with the second cavity, The second pocket communicates with the first fluid channel.
The ablation system according to claim 2, wherein the first expandable element is integrally formed with the second expandable element.
The ablation system according to claim 2, wherein the expandable member further comprises a connecting tube located outside the flow channel, the connecting tube is fixedly connected to the first expandable element, and the connecting tube Fixedly connected with the second expandable element, the connecting tube has a lumen, and the lumen communicates with the first cavity and the second cavity.
The ablation system according to claim 4, characterized in that, the flow channel is passed through the lumen, the proximal end of the connecting tube is fixedly connected to the distal end of the second expandable member, and the connection The distal end of the tube is fixedly connected to the proximal end of the first expandable member.
The ablation system according to claim 5, wherein a breach is provided on the tube wall of the connecting tube, and a wall for injecting the second fluid is provided on the side wall of the flow channel passing through the second fluid channel. The injection through hole, the position of the injection through hole corresponds to the position of the breach, the inner wall of the lumen includes a first sealing area, the first sealing area is arranged around the periphery of the breach, the The flow pipe is provided with a second sealing area around the injection through hole, and the first sealing area is in sealing connection with the second sealing area.
The ablation system according to claim 4, wherein the distal end of the flow channel includes a first area, a second area and a third area arranged along the axial direction of the flow channel, and the second area is located at Between the first area and the third area, the first expandable element is located in the first area, the second expandable element is located in the third area, and the number of connecting pipes is at least One, the connecting tube is located at least in the second area and the flow channel is located outside the lumens of all the connecting tubes, and the flow channel passes through the first cavity and the second cavity.
The ablation system according to claim 7, characterized in that, the side wall of the flow channel passing through the second fluid channel is provided with an injection through hole for injecting the second fluid, and the second area includes a first A setting area and a second setting area, the connecting pipe is located in the first setting area, and the injection through hole is located in the second setting area.
The ablation system according to claim 8, wherein the number of the connecting tubes is at least two, and the at least two connecting tubes are arranged at intervals along the circumference of the flow channel, and the number of the connecting tubes along the circumference of the flow channel In the direction, a gap is formed between two adjacent connecting pipes, and the spraying through hole is provided at a position corresponding to the gap in the flow pipe.
The ablation system according to claim 2, wherein the distal end of the flow channel comprises a first area, a second area and a third area arranged along the axial direction of the flow channel, and the second area is located at Between the first region and the third region; the first expandable member is located in the first region, the second expandable member is located in the third region, and the second region includes the first a setting area and a second setting area; the expandable member further includes an air guiding part covering the first setting area, the distal end of the air guiding part is fixedly connected to the proximal end of the first expandable part, The proximal end of the air guiding part is fixedly connected to the distal end of the second expandable part, the air guiding part has an air guiding channel communicating with the first cavity and the second cavity, and the first The second installation area is exposed outside the air guiding part, and the side wall of the second fluid channel of the flow duct forms an injection through hole for injecting the second fluid in the second installation area.
The ablation system according to claim 2, wherein the expandable member further comprises a third expandable part, the third expandable part has a third cavity, and the third cavity is connected to the first The first cavity communicates with the second cavity.
The ablation system according to claim 2, wherein the ablation system further comprises a first developing object and a second developing object, the first developing object is located on the first expandable member or on the communication channel. The position on the pipeline corresponds to the first expandable component, and the second developer is located on the second expandable component or located on the flow channel at a position corresponding to the second expandable component.
The ablation system according to any one of claims 1-12, characterized in that, the flow channel comprises an inner tube and an outer tube, the inner tube is passed through the outer tube, and the inner tube is provided with the The second fluid channel; the outer wall of the inner tube and the inner wall of the outer tube jointly enclose the first fluid channel; the expandable member is sleeved on the inner tube, and the proximal end of the expandable member It is fixedly connected with the distal end of the outer tube and communicates with the first fluid channel.
The ablation system according to any one of claims 1-12, characterized in that, the flow channel is a multi-lumen channel, and the flow channel further includes a storage cavity, and the storage cavity is isolated from the first fluid channel It is provided that the storage cavity and the second fluid channel are isolated from each other, and the second conduit is passed through the storage cavity.
The ablation system according to any one of claims 1-14, wherein the first catheter further comprises a head end, the proximal end of the head end is arranged at the distal end of the flow channel; the outer end of the head end The diameter decreases from the proximal end of the head end to the far end of the head end; the head end includes a hollow cavity communicated with the second fluid channel, and the second conduit passes through the head end The distal end of the head is exposed.
The ablation system according to claim 15, characterized in that, the peripheral wall of the distal end of the head end is provided with an injection port communicating with the hollow cavity, and the injection port is used to inject the second fluid.
The ablation system according to claim 15 or 16, wherein a step is formed on the inner wall of the hollow cavity, and the distal end of the flow channel is accommodated in the hollow cavity and abuts against the step.
The ablation system according to claim 17, wherein the outer wall of the head end is coated with a protective layer.
The ablation system according to claim 18, wherein the first catheter further comprises a connector, the connector is provided with a first fluid injection port and a second fluid injection port, and the connector is fixedly sleeved On the flow pipe, the second conduit is passed through the connector, and the first fluid injection port is used to inject the first fluid into the first fluid channel; the second fluid injection port Used for injecting the second fluid into the second fluid channel.
The ablation system according to claim 19, wherein the connector comprises a first connector and a second connector, the first connector is fixedly sleeved on the flow channel, and the flow channel The proximal end is fixedly connected to the distal end of the second connector; the second conduit is passed through the second connector; the first fluid injection port is arranged at the first connector, and the second The fluid injection port is arranged on the second connector.
The ablation system according to claim 20, wherein the first connector comprises a first tube body and a first injection tube fixedly connected, the first injection tube has the first fluid injection port, and The circulation channel is passed through the first tube body and exposes the proximal end of the first tube body, and the first injection tube communicates with the first fluid channel.
The ablation system according to claim 20, wherein the second connector comprises a second tube body and a second injection tube fixedly connected, and the second injection tube has the second fluid injection port; The distal end of the second tube body is fixedly connected to the proximal end of the flow channel, the second tube body communicates with the second fluid channel, and the second conduit is passed through the second tube body.
The ablation system according to claim 18, characterized in that, the connector includes a second installation hole arranged along the axial direction of the connector, and the proximal end surface of the connector is provided with the second installation hole. The first conduit further includes a gasket, the gasket is accommodated in the flare and is sealed with the connector, the gasket is provided with a second insertion hole, and the second The conduit passes through the second installation hole and the second insertion hole.
The ablation system according to claim 19, wherein the first catheter further comprises a tail cap fixedly connected to the proximal end of the connector, the proximal end of the tail cap is provided with a catheter hole, and the first catheter Two conduits pass through the conduit hole.
The ablation system according to claim 24, characterized in that, the tail cap comprises a sleeve part and a joint part accommodated in the sleeve part, the proximal end of the joint part and the proximal end of the sleeve part Fixedly connected, the conduit hole passes through the proximal end surface of the joint part and the distal end surface of the joint part, and the proximal end of the connector is sandwiched between the sleeve part and the joint part.
The ablation system according to claim 19, characterized in that, the ablation system further comprises a sheath, the sheath is sheathed on the distal end of the connector, and the flow channel is passed through the sheath .
The ablation system according to claim 15, wherein the second catheter comprises a metal shaft tube, a flexible tube, an electrode, a support wire and an electrical connector, and the distal end of the flexible tube exposes the distal end of the flow channel. end, the distal end of the metal shaft tube is fixedly connected to the proximal end of the flexible tube, the proximal end of the metal shaft tube is fixedly connected to the electrical connector, and the electrodes are arranged at the distal end of the flexible tube It is also electrically connected with the electrical connector for potential mapping, and the support wire is passed through the flexible tube.
The ablation system according to claim 27, wherein the electrodes are also used to generate a pulsed electric field to perform pulse ablation on the target tissue region; and/or, the electrodes are also used to deliver radio frequency energy to ablate the target tissue area; performing radiofrequency ablation on the target tissue region; and/or, the electrodes are also used to transmit microwave energy to perform microwave ablation on the target tissue region.
The ablation system according to claim 27, wherein the flexible tube includes a bearing part and a connecting part, the distal end of the connecting part is fixedly connected to the proximal end of the bearing part, and the connecting part is passed through In the circulation pipe, the bearing part is located outside the circulation pipe, the electrodes are arranged on the bearing part, the bearing part includes a helical structure and/or a curved structure, and the helical structure is along the connecting part The axial spiral extends, and the curved structure is arranged at the most distal end of the bearing part and is bent relative to the axial direction of the connecting part.
The ablation system according to claim 27, wherein the support wire comprises a small-diameter portion located at the distal end of the support wire and a large-diameter portion located at the proximal end of the support wire, and the outer diameter of the large-diameter portion is The outer diameter of the small-diameter portion is larger than that of the small-diameter portion, and the small-diameter portion is passed through the flexible tube.
The ablation system according to claim 27, wherein the electrodes include a ring electrode and a head electrode, the ring electrode is sleeved on the flexible tube and electrically connected to the electrical connector, and the head electrode Fixed to the most distal end of the flexible tube, the head electrode is electrically connected to the electrical connector.