Radio frequency ablation catheter, flexible electrode thereof and radio frequency ablation system

Abstract

The invention provides a radiofrequency ablation catheter, a flexible electrode of the radiofrequency ablation catheter and a radiofrequency ablation system. The flexible electrode comprises a flexible metal electrode layer, a lining plate layer, a first flexible conductor layer, a substrate layer and a second flexible conductor layer which are sequentially arranged in a stacked mode, the lining plate layer and the substrate layer are made of flexible insulating materials, and a power connection area of the flexible metal electrode layer is used for being connected with the far end of a radio frequency cable of the radio frequency ablation catheter. The far end of the flexible metal electrode layer is provided with a radio frequency conduction area used for conducting radio frequency energy to target tissue, the far end of the substrate layer is provided with an electric connection part, and the far end of the second flexible conductor layer is electrically connected with the far end of the first flexible conductor layer through the electric connection part. The orthographic projection of the joint of the far ends of the first flexible conductor layer and the second flexible conductor layer and the electric connection part on the first surface falls in the radio frequency conduction area, and the near ends of the second flexible conductor layer and the first flexible conductor layer are used for being connected with the far ends of two wires of the radio frequency ablation catheter to form a thermocouple loop.

Description

Technical Field

[0001] The present disclosure relates to the technical field of medical equipment, and in particular to a radiofrequency ablation catheter and a flexible electrode thereof, and a radiofrequency ablation system. Background Art

[0002] At present, radio frequency ablation (RFA) is widely used in the medical field to treat arrhythmias, tumors and other diseases. Its working principle is to apply radio frequency current to the target tissue (such as tumors, heart disease foci) through electrodes. When the radio frequency current flows in the target tissue, it is converted into heat energy. The temperature of the target tissue rises rapidly, causing the water in the cells to evaporate and the protein to denature, thereby causing necrosis of the target tissue. It can be seen that the key to radio frequency ablation technology lies in precise temperature control.

[0003] As a common medical device that uses radiofrequency ablation technology for treatment, radiofrequency ablation catheters are also equipped with temperature sensing elements to achieve precise temperature control. The temperature sensing elements are located near the electrodes to monitor the temperature of the target tissue. During treatment, radiofrequency ablation catheters often need to be inserted into the patient's body through natural cavities (such as blood vessel lumens). The electrodes made of metal materials are placed against the target tissue for discharge, and the radiofrequency current is conducted along the electrodes to the target tissue.

[0004] However, in actual use, this radiofrequency ablation catheter encounters great resistance during the process of being inserted into the patient's body. Summary of the invention

[0005] The disclosed embodiments provide a radiofrequency ablation catheter and a flexible electrode thereof, and a radiofrequency ablation system, which can reduce the resistance encountered by the radiofrequency ablation catheter using the flexible electrode during the process of inserting the catheter into the patient's body.

[0006] According to a first aspect of the present disclosure, there is provided a flexible electrode for a radiofrequency ablation catheter, comprising: a flexible metal electrode layer, a liner layer, a first flexible conductor layer, a substrate layer, and a second flexible conductor layer;

[0007] The flexible metal electrode layer has a first surface and a second surface opposite to the first surface along its thickness direction, the power connection area of ​​the flexible metal electrode layer is used to connect with the distal end of the radio frequency cable of the radio frequency ablation catheter, and the distal end of the flexible metal electrode layer has a radio frequency conduction area, and the radio frequency conduction area is configured to conduct radio frequency energy to the target tissue;

[0008] The lining layer is arranged on the second surface, and the lining layer is made of a flexible insulating material;

[0009] The first flexible conductor layer is stacked on a side of the liner layer facing away from the flexible metal electrode layer, and the first flexible conductor layer and the flexible metal electrode layer are insulated and isolated by the liner layer;

[0010] The substrate layer is arranged on a side of the first flexible conductor layer facing away from the flexible metal electrode layer, an electrical connection portion is arranged at a distal end of the substrate layer, and the substrate layer is made of a flexible insulating material;

[0011] The second flexible conductor layer is stacked on the side of the substrate layer facing away from the flexible metal electrode layer. The second flexible conductor layer and the first flexible conductor layer are insulated and isolated by the substrate layer. The distal end of the second flexible conductor layer is electrically connected to the distal end of the first flexible conductor layer through an electrical connection portion. The orthographic projections of the connection between the distal end of the first flexible conductor layer and the distal end of the second flexible conductor layer and the electrical connection portion fall within the radio frequency conduction area on the first surface. The proximal end of the second flexible conductor layer and the proximal end of the first flexible conductor layer are used to respectively connect to the distal ends of the two wires of the radio frequency ablation catheter to form a thermocouple loop.

[0012] The flexible electrode of the disclosed embodiment can perform radiofrequency ablation and monitor the temperature of the radiofrequency ablation area. At the same time, by designing each layer of the flexible electrode to be flexible, the flexible electrode as a whole has good flexibility, and the flexible metal electrode layer, the first flexible conductor layer and the second flexible conductor layer are designed to be stacked along the thickness direction, so that when the radiofrequency ablation catheter adopts the flexible electrode of the disclosed embodiment, the resistance encountered during the intervention in the patient's body is reduced.

[0013] In some embodiments, the proximal end of the first flexible conductor layer has a first connection area, and the first connection area is connected to one of the two wires; the proximal end of the second flexible conductor layer has a second connection area, and the second connection area is used to connect to the other of the two wires; the orthographic projections of the first connection area and the second connection area on the first surface are staggered, and the orthographic projection of the first connection area on the first surface does not fall within the orthographic projection area of ​​the second flexible conductor layer on the first surface.

[0014] In some embodiments, the orthographic projection of the first flexible conductor layer on the first surface falls within the boundary of the orthographic projection area of ​​the substrate layer on the first surface, and the proximal end of the substrate layer exceeds the proximal end of the second flexible conductor layer in its own extension direction; a first conductive through hole is provided at the proximal end of the substrate layer, and the first conductive through hole is provided at the part of the substrate layer that exceeds the proximal end of the second flexible conductor layer, and the first connection area is connected to one of the two wires through the first conductive through hole.

[0015] In some embodiments, the flexible electrode also includes a back film layer stacked on the side of the second flexible conductor layer facing away from the flexible metal electrode layer, the side of the back film layer facing away from the flexible metal electrode layer is used to connect to the supporting carrier of the radio frequency ablation catheter, and the back film layer is made of a flexible insulating material; the proximal end of the back film layer is provided with a first through hole and a second through hole spaced apart from each other, the first through hole is used to expose the connection point between the first conductive through hole and one of the two wires, and the second through hole is used to expose the connection point between the second connection area and the other of the two wires.

[0016] In some embodiments, the flexible electrode also includes a conductive layer, which is arranged on the same layer as the second flexible conductor layer, the proximal ends of the conductive layer and the second flexible conductor layer are adjacent to and spaced apart from each other, and the first conductive through-hole is connected to one of the two wires through the conductive layer; and / or, the proximal end of the back film layer is configured as a rectangle, and the first through-hole and the second through-hole are arranged at both ends of the diagonal of the rectangle along its own extension direction.

[0017] In some embodiments, the flexible electrode also includes a coating layer, which is arranged on the side of the flexible metal electrode layer facing away from the lining layer. The coating layer is provided with a first window and a second window, the first window exposes the power connection area, and the second window exposes the radio frequency conduction area; the coating layer is made of a flexible insulating material.

[0018] In some embodiments, the electrical connection portion is a second conductive via that penetrates through the thickness of the distal end of the substrate layer.

[0019] In some embodiments, the total thickness of the flexible electrode is less than or equal to 0.2 mm.

[0020] According to a second aspect of the present disclosure, a radiofrequency ablation catheter is provided, comprising: an expandable support carrier and a flexible electrode assembly, wherein the flexible electrode assembly comprises one or more flexible electrodes of any one of the types provided in the first aspect of the present disclosure, and the flexible electrodes are attached to the support carrier.

[0021] In some embodiments, the radiofrequency ablation catheter also includes a tube body, the supporting carrier is a balloon, and the proximal end of the balloon is arranged on the tube body; the flexible electrode assembly includes: a fixing ring and a plurality of flexible electrodes, the fixing ring is sleeved to the outer periphery of the proximal shaft segment of the balloon; the plurality of flexible electrodes are all connected to the fixing ring, and the distal end and proximal end of any flexible electrode are respectively located on both sides of the fixing ring along its axial direction, the parts of each flexible electrode located on the distal side of the fixing ring are independent of each other and attached to the balloon, and the parts of each flexible electrode located on the proximal side of the fixing ring have at least two common lining layers and substrate layers and extend into the lumen of the tube body.

[0022] In some embodiments, the supporting carrier is a balloon, and the flexible electrode assembly includes a plurality of flexible electrodes, the distal ends of all the flexible electrodes are evenly and spaced apart around the longitudinal axis of the balloon, and the distal ends of all the flexible electrodes are distributed sequentially along the longitudinal axis of the balloon from the proximal end to the distal end of the balloon.

[0023] According to a third aspect of the present disclosure, a radiofrequency ablation system is provided, comprising: a radiofrequency device and any radiofrequency ablation catheter provided in the second aspect of the present disclosure, wherein the proximal end of the radiofrequency cable of the radiofrequency ablation catheter is connected to the radiofrequency device.

[0024] These and other aspects of the disclosure will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Further details, features and advantages of the present disclosure are disclosed in the following description of exemplary embodiments in conjunction with the accompanying drawings, in which:

[0026] Figure 1 It is a schematic diagram of the partial structure of a radiofrequency ablation catheter according to some embodiments of the present disclosure;

[0027] Figure 2 It is a schematic diagram of the partial structure of the radiofrequency ablation catheter according to other embodiments of the present disclosure;

[0028] Figure 3 It is a schematic diagram of the structure of the flexible electrode in some embodiments of the present disclosure;

[0029] Figure 4 They are shown respectively Figure 3 A partial enlarged schematic diagram of A, B, and C in the middle;

[0030] Figure 5 A simplified schematic diagram of the connection between the flexible electrode and the wire in some embodiments of the present disclosure;

[0031] Figure 6 A simplified schematic diagram of the connection between flexible electrodes and wires in other embodiments of the present disclosure;

[0032] Figure 7 It is a schematic diagram of the back side of the flexible electrode of some embodiments of the present disclosure;

[0033] Figure 8 It is a front schematic diagram of a flexible electrode according to some embodiments of the present disclosure;

[0034] Fig. 9 This is a schematic structural diagram of the flexible electrode assembly in the unfolded state in some embodiments of the present disclosure.

[0035] Description of reference numerals:

[0036] 100-RF ablation catheter;

[0037] 10-support carrier, 11-balloon;

[0038] 20-flexible electrode assembly, 21-fixing ring, 22-flexible electrode, 221-film layer, 2211-first window, 2212-second window, 222-fourth adhesive layer, 2221-fifth opening, 2222-sixth opening, 223-flexible metal electrode layer, 224-lining layer, 225-first adhesive layer, 226-first flexible conductor layer, 227-substrate layer, 2271-electrical connection part, 2272-second conductive through hole, 2273-first conductive through hole, 228-second adhesive layer, 2281-first opening, 2282-second opening, 229-second flexible conductor layer, 2291-insulating hole, 230-third adhesive layer, 2301-third opening, 2302-fourth opening, 231-back film layer, 2311-first through hole, 2312-second through hole, 232-conductive layer, 233a, 233b, 233c, 233d-gold-plated layer;

[0039] 30-tube body;

[0040] 40a, 40b-wires. DETAILED DESCRIPTION

[0041] In the following, only some exemplary embodiments are briefly described. As those skilled in the art will appreciate, the described embodiments may be modified in various ways without departing from the spirit or scope of the present disclosure. Therefore, the drawings and descriptions are considered to be exemplary and non-restrictive in nature.

[0042] As used herein, the terms "patient," "host," and "user" refer to any human or animal subject, and are not intended to limit the systems or methods or uses to human use, although use of the subject invention in human patients represents a preferred embodiment.

[0043] In order to reduce the resistance encountered by the RF ablation catheter during the process of inserting it into the patient's body, the volume of the distal end of the RF ablation catheter should be as small as possible. In order to allow the electrode to fit well to the target tissue during treatment, the volume of the distal end of the RF ablation catheter should be larger. It can be seen that the volume requirements of the RF ablation catheter are opposite at different stages. In view of this, some existing related technologies have proposed setting the electrode on a memory metal component, which can be constrained into a narrow configuration to pass through the natural cavity. When reaching the target tissue, the memory metal component will restore its deformation and increase in volume.

[0044] However, since the electrodes made of metal materials have great hardness, and the electrodes and the temperature sensing elements located near the electrodes are laid flat on the memory metal component, the memory metal component carrying the electrodes and the temperature sensing elements is difficult to shrink into a smaller volume even if it is constrained and formed, and the resistance encountered during the intervention into the patient's body is still relatively large.

[0045] Figure 1 is a schematic diagram of a partial structure of a radiofrequency ablation catheter according to some embodiments of the present disclosure, Figure 2 FIG. 1 is a schematic diagram of the partial structure of a radiofrequency ablation catheter according to other embodiments of the present disclosure. Figure 1 and Figure 2 As shown, the embodiment of the present disclosure provides a flexible electrode, which is applied to a radiofrequency ablation catheter 100 and is specifically arranged on an expandable and contractible support carrier 10 (such as a memory metal component, a balloon 11, etc.) of the radiofrequency ablation catheter 100. For the sake of clarity, the balloon 11 is used as an example in the following description.

[0046] Figure 3 FIG. 2 is a schematic diagram of the structure of the flexible electrode 22 in some embodiments of the present disclosure. Figure 3 As shown, the flexible electrode 22 includes: a flexible metal electrode layer 223, a lining layer 224, a first flexible conductor layer 226, a substrate layer 227 and a second flexible conductor layer 229. The flexible metal electrode layer 223 has a first surface and a second surface opposite to the first surface along its thickness direction. The lining layer 224 is arranged on the second surface. The first flexible conductor layer 226 is stacked on the side of the lining layer 224 opposite to the flexible metal electrode layer 223. The substrate layer 227 is arranged on the side of the first flexible conductor layer 226 opposite to the flexible metal electrode layer 223. The second flexible conductor layer 229 is stacked on the side of the substrate layer 227 opposite to the flexible metal electrode layer 223. Along the radial direction of the balloon 11, from the outer surface of the balloon 11 to the inner surface of the balloon 11, the flexible metal electrode layer 223, the lining layer 224, the first flexible conductor layer 226, the substrate layer 227 and the second flexible conductor layer 229 are stacked in sequence. That is, the first surface faces away from the outer surface of the balloon 11 , the second surface faces the outer surface of the balloon 11 , and the second flexible conductor layer 229 is closer to the outer surface of the balloon 11 than the flexible metal electrode layer 223 .

[0047] The material of the flexible metal electrode layer 223 can be selected from any of the flexible conductors such as copper, gold, silver, aluminum, etc., so that the flexible metal electrode layer 223 has high conductivity and a certain bending and deformation ability. All or part of the distal end of the flexible metal electrode layer 223 is a radio frequency conduction area. The radio frequency ablation catheter 100 is inserted into the patient's body, and the distal end of the flexible metal electrode layer 223 is close to the target tissue. The radio frequency conduction area is configured to conduct radio frequency energy to the target tissue. The configuration of the radio frequency conduction area can be any of the shapes such as circular, rectangular, and elliptical.

[0048] In the embodiment of the present disclosure, taking the flexible metal electrode layer 223 as an example, the end of the flexible metal electrode layer 223 or its components that is closer to the operator in the extension direction is defined as the "proximal end", and similarly, the end of the flexible metal electrode layer 223 or its components that is farther away from the operator in the extension direction is defined as the "distal end". The definitions of the "proximal end" and "distal end" of other layers or components on the flexible electrode 22 except the flexible metal electrode layer 223, and the definitions of the "proximal end" and "distal end" of the balloon 11 or its components can all refer to the flexible metal electrode layer 223, and will not be repeated here. As discussed herein, the "operator" may include a doctor, a surgeon, or any other individual or delivery instrument associated with delivering the radiofrequency ablation catheter 100 to a patient.

[0049] The lining layer 224 is made of a flexible insulating material, so that the lining layer 224 has a flexible deformation capability. Exemplarily, the flexible insulating material can be polyimide (PI), polyethylene terephthalate (PET), polyurethane (PU) or a combination thereof. The lining layer 224 can also be used to insulate and isolate the flexible metal electrode layer 223 and the first flexible conductor layer 226, so as to prevent the flexible metal electrode layer 223 and the first flexible conductor layer 226 from being connected and causing a short circuit.

[0050] Similar to the liner layer 224 , the substrate layer 227 is also made of a flexible insulating material, so that the substrate layer 227 has flexible deformation capability and insulating isolation capability, so as to be used for insulating and isolating the first flexible conductor layer 226 and the second flexible conductor layer 229 . Figure 4 They are shown respectively Figure 3 The local enlarged schematic diagram of A, B, and C in the figure is as follows: Figure 3 and Figure 4 As shown in (A), an electrical connection portion 2271 is also provided at the distal end of the substrate layer 227 .

[0051] The distal end of the first flexible conductor layer 226 is electrically connected to the distal end of the second flexible conductor layer 229 through the electrical connection portion 2271. One of the first flexible conductor layer 226 and the second flexible conductor layer 229 is made of a thermocouple positive electrode conductor material, and the other is made of a thermocouple negative electrode conductor material. The proximal end of the first flexible conductor layer 226 and the proximal end of the second flexible conductor layer 229 are respectively connected to the distal ends of the two wires 40a and 40b of the radio frequency ablation catheter 100 to form a thermocouple loop. The orthographic projections of the connection points of the distal ends of the first flexible conductor layer 226 and the second flexible conductor layer 229 with the electrical connection portion 2271 both fall within the radio frequency conduction area, that is, the connection point of the distal ends of the first flexible conductor layer 226 and the second flexible conductor layer 229 corresponds to the radio frequency conduction area. In this way, the temperature of the target tissue can be transmitted to the connection point of the distal end of the first flexible conductor layer 226 and the distal end of the second flexible conductor layer 229 through the radio frequency conduction area, and the connection point of the distal end of the first flexible conductor layer 226 and the distal end of the second flexible conductor layer 229 can be affected by the temperature change of the target tissue. By using the thermocouple effect, the temperature of the connection point of the distal ends of the first flexible conductor layer 226 and the second flexible conductor layer 229, that is, the temperature of the radio frequency conduction area and the target tissue can be detected. In order to make the thermocouple loop form a closed loop, the proximal ends of the two wires 40a and 40b can be connected to a voltage measuring instrument (such as a voltmeter). In other words, one of the first flexible conductor layer 226 and the second flexible conductor layer 229 is equivalent to the positive pole of the thermocouple, and the other is equivalent to the negative pole of the thermocouple. The two wires 40a and 40b are respectively the positive pole wire and the negative pole wire. The one of the first flexible conductor layer 226 and the second flexible conductor layer 229 as the positive pole of the thermocouple is connected to the positive pole wire, and the one as the negative pole is connected to the negative pole wire.

[0052] It can be understood that the thermocouple described in this article can be selected from any of several models that meet the requirements that both the positive electrode material and the negative electrode material can withstand a certain degree of bending: K-type thermocouple, the positive electrode material is nickel-chromium alloy, and the negative electrode material is nickel-silicon alloy; T-type thermocouple, the positive electrode material is copper, and the negative electrode material is copper-nickel alloy; J-type thermocouple, the positive electrode material is pure iron, and the negative electrode material is copper-nickel alloy; N-type thermocouple, the positive electrode material is nickel-chromium-silicon alloy, and the negative electrode material is nickel-silicon-magnesium alloy.

[0053] In order to transmit radio frequency current to the flexible metal electrode layer 223 for ablation, the power connection area of ​​the flexible metal electrode layer 223 is connected to the distal end of the radio frequency cable of the radio frequency ablation catheter 100, and the proximal end of the radio frequency cable is connected to the radio frequency device. The power connection area can be located at the proximal end of the flexible metal electrode layer 223, or at the part between the proximal end and the distal end of the flexible metal electrode layer 223.

[0054] The flexible electrode 22 of the embodiment of the present disclosure is designed to conduct radio frequency energy to the target tissue by designing the radio frequency conduction area of ​​the flexible metal electrode layer 223, and is also designed to connect the first flexible conductor layer 226 and the second flexible conductor layer 229 at the distal end, and the connection point corresponds to the radio frequency conduction area, so as to monitor the temperature of the radio frequency conduction area. In summary, the flexible electrode 22 of the embodiment of the present disclosure integrates the functions of the ablation electrode and the thermocouple.

[0055] When the radiofrequency ablation catheter 100 adopts the flexible electrode 22 of the embodiment of the present disclosure, the resistance encountered during the intervention in the patient's body is reduced. This is due to the flexibility of each layer of the flexible electrode 22 designed in this embodiment, and the overall flexibility of the flexible electrode 22. The flexible electrode 22 can be deformed with the expansion and contraction process of the support carrier 10, so that the flexible electrode 22 can be adaptively deformed when the support carrier 10 is in a contracted state, so that the contracted support carrier 10 and the flexible electrode 22 have a smaller volume. On the other hand, it is also due to the flexible metal electrode layer 223, the first flexible conductor layer 226 and the second flexible conductor layer 229 stacked along their own thickness direction, so that the components for monitoring temperature do not need to occupy additional space on the surface of the support carrier 10, which has a positive effect on further reducing the volume of the contracted support carrier 10 and the flexible electrode 22.

[0056] In some embodiments of the present disclosure, a first adhesive layer 225 may be further provided between the lining layer 224 and the first flexible conductor layer 226. The first adhesive layer 225 is used to bond the lining layer 224 and the first flexible conductor layer 226 together, which is beneficial to improving the stability of the relative position of the lining layer 224 and the first flexible conductor layer 226.

[0057] Figure 5 FIG. 2 is a simplified schematic diagram of the connection between the flexible electrode 22 and the wire in some embodiments of the present disclosure. Figure 5 As shown, the proximal end of the first flexible conductor layer 226 has a first connection area, and the first connection area is connected to one of the two wires (i.e., wire 40a). Similarly, the proximal end of the second flexible conductor layer 229 has a second connection area, and the second connection area is used to connect to the other of the two wires (i.e., wire 40b). It can be understood that the connection position of the first connection area and the corresponding wire 40a and the connection position of the second connection area and the corresponding wire 40b are various.

[0058] In some embodiments of the present disclosure, Figure 5 As shown, the orthographic projections of the first connection area and the second connection area on the first surface are staggered, and the orthographic projection of the first connection area on the first surface may not fall within the orthographic projection area of ​​the second flexible conductor layer 229 on the first surface. Figure 6FIG. 2 is a simplified schematic diagram of the connection between the flexible electrode 22 and the wire in some other embodiments of the present disclosure. Figure 6 Compared with the technical solution in which the orthographic projection of the first connection area on the first surface falls within the orthographic projection area of ​​the second flexible conductor layer 229 on the first surface, the present embodiment is designed so that the second flexible conductor layer 229 does not need to be designed with an insulating hole 2291 for the wire 40a to pass through. This is not only conducive to simplifying the structural design of the flexible electrode 22 and facilitating manufacturing, but also helps prevent the first flexible conductor layer 226 from being connected to the second flexible conductor layer 229 through the wire 40a and causing a short circuit.

[0059] like Figure 5 As shown in (A), the proximal end of the first flexible conductor layer 226 can exceed the proximal end of the substrate layer 227 in its extension direction. In this example, the orthographic projection of the first flexible conductor layer 226 on the first surface and the orthographic projection of the substrate layer 227 on the first surface are partially non-overlapping, and the orthographic projection of the second flexible conductor layer 229 on the first surface falls within the orthographic projection of the substrate layer 227 on the first surface. The first connection area is located at the proximal end of the first flexible conductor layer 226 protruding from the substrate layer 227.

[0060] Please combine Figure 3 and Figure 5 As shown in (B), the orthographic projection of the first flexible conductor layer 226 on the first surface can also be designed to fall within the boundary of the orthographic projection area of ​​the substrate layer 227 on the first surface, and the proximal end of the substrate layer 227 exceeds the proximal end of the second flexible conductor layer 229 in its own extension direction, that is, the proximal end of the substrate layer 227 protrudes from the proximal end of the second flexible conductor layer 229. In order to achieve connection, a first conductive through hole 2273 is further provided at the proximal end of the substrate layer 227, and the first connection area is connected to the wire 40a through the first conductive through hole 2273.

[0061] By comparison, we can see that Figure 5 In the embodiment shown in (A), the wire 40a can be directly extended to connect with the first connection area, and the transmission loop of the current of the thermocouple loop between the wire 40a and the first connection area omits the first conductive through hole 2273 of the substrate layer 227, which is beneficial to reduce resistance and energy loss. Figure 5 In the embodiment shown in (B), the proximal end of the first flexible conductor layer 226 does not protrude from the substrate layer 227, which helps to reduce the risk of short circuit between the first flexible conductor layer 226 and the second flexible conductor layer 229 due to conduction of electrical interference sources in the environment.

[0062] In some embodiments of the present disclosure, please continue to refer to Figure 3The flexible electrode 22 may further include a back film layer 231, which is stacked on the side of the second flexible conductor layer 229 facing away from the flexible metal electrode layer 223. When the flexible electrode 22 is applied to the radiofrequency ablation catheter 100, the side of the back film layer 231 facing away from the flexible metal electrode layer 223 is attached to the outer surface of the support carrier 10. The back film layer 231 is made of a flexible insulating material, and the material of the back film layer 231 may be polyimide (PI), polyethylene terephthalate (PET), polyurethane (PU) or a combination thereof. In this embodiment, by introducing the back film layer 231, the back film layer 231 can provide electrical insulation protection and mechanical protection for the side of the second flexible conductor layer 229 facing away from the flexible metal electrode layer 223, and reduce the risk of short circuit by isolating the electrical interference source in the external environment from being connected to the second flexible conductor layer 229. In addition, the back film layer 231 is made of flexible insulating material. Therefore, after the back film layer 231 is introduced, the flexible electrode 22 as a whole still has good flexibility, so that the problem of large resistance encountered by the radiofrequency ablation catheter 100 using the flexible electrode 22 during intervention into the human body can still be improved.

[0063] In this example, Figure 3 and Figure 4 As shown in (B), the proximal end of the back film layer 231 is also penetrated by a first through hole 2311 and a second through hole 2312 spaced apart from each other. The first through hole 2311 is configured to expose the connection point between the first conductive via 2273 and the wire 40a, and the second through hole 2312 is configured to expose the connection point between the second connection area and the wire 40b. That is, the first through hole 2311 is used to define the connection position of the wire 40a, and the second through hole 2312 is used to define the connection position of the wire 40b, so as to prevent the back film layer 231 from hindering the connection between the first conductive via 2273 and the wire 40a, and the connection between the second connection area and the wire 40b. The shapes of the first conductive via 2273, the first through hole 2311 and the second through hole 2312 are not limited, and can be any one of circular, rectangular, elliptical, etc.

[0064] As an optional example of the present disclosure, the first through hole 2311 may be completely opposite to or partially opposite to the first conductive via 2273 , and the first through hole 2311 exposes at least a portion of the first conductive via 2273 .

[0065] As another optional example of the present disclosure, Figure 3 and Figure 4As shown in (B), the first through hole 2311 and the first conductive through hole 2273 can be completely staggered. In this example, the flexible electrode 22 can also include a conductive layer 232, which is arranged on the same layer as the second flexible conductor layer 229. The conductive layer 232 and the proximal end of the second flexible conductor layer 229 are adjacent and spaced apart, and the conductive layer 232 is connected to the first conductive through hole 2273. The first through hole 2311 exposes the conductive layer 232. In this embodiment, by introducing the conductive layer 232, the positional relationship between the first through hole 2311 and the first conductive through hole 2273 can be flexibly arranged. Even if the two are staggered, the first conductive through hole 2273 can be connected to the wire 40a through the conductive layer 232. Figure 3 As shown, the size of the first conductive via 2273 may be smaller than that of the first through hole 2311 ; of course, in other embodiments, the size of the first conductive via 2273 may also be greater than or equal to that of the first through hole 2311 .

[0066] In some embodiments, the distal end of the wire 40a can be directly electrically connected to the exposed portion of the first through hole 2311. In some embodiments, a deposition process can also be used to deposit a conductive metal material (e.g., gold, silver, platinum, copper) on the first through hole 2311 and the second through hole 2312. Exemplarily, the deposition process can be any one of electroplating and chemical plating (e.g., physical vapor deposition PVD, chemical vapor deposition CVD). Taking the gold plating of the first through hole 2311 and the second through hole 2312 as an example, the back side schematic diagram of the obtained flexible electrode 22 is as follows: Figure 7 As shown, the gold-plated layer 233a corresponding to the first through hole 2311 and the gold-plated layer 233b corresponding to the second through hole 2312 are exposed on the back of the flexible electrode 22, so as to be connected to the distal ends of the two wires 40a and 40b by welding or the like. By depositing the plating layer on the first through hole 2311 and the second through hole 2312, the connection reliability between the plating layer and the wire is stronger, which is conducive to improving the stability of the electrical connection. Figure 3 As shown, in an embodiment where the first through hole 2311 is completely offset from the first conductive via 2273, the conductive metal material will not be deposited to the first conductive via 2273 during the subsequent deposition process. Even if the aperture of the first conductive via 2273 is designed to be smaller, it will not have a negative impact on the difficulty of the deposition process, and the aperture limitation of the first conductive via 2273 is small.

[0067] The configuration of the proximal end of the back film layer 231 is not limited, and can be, for example, any of a circular, rectangular, elliptical, etc. For example, Figure 3 and Figure 4As shown in (B), the proximal end of the back film layer 231 can be configured to be rectangular, and at the same time, the first through hole 2311 and the second through hole 2312 are arranged at both ends of the diagonal line of the rectangle along its own extension direction. In other words, the first through hole 2311 and the second through hole 2312 are respectively arranged close to the two diagonal points of the proximal end of the rectangular back film layer 231. This embodiment is designed in this way, when the proximal end of the back film layer 231 is rectangular, without changing other parameters, the distance between the first through hole 2311 and the second through hole 2312 can be made larger, which is conducive to reducing the risk of short circuit caused by the flexible electrode 22 being connected to the connection points of the two wires 40a and 40b.

[0068] It should be noted that the rectangle referred to in this article is not limited to a right-angled rectangle, but may also be a rounded rectangle or a deformation thereof.

[0069] In some embodiments of the present disclosure, a second adhesive layer 228 may be provided between the substrate layer 227 and the second flexible conductor layer 229. The second adhesive layer 228 is used to bond the substrate layer 227 and the second flexible conductor layer 229 together, which is conducive to improving the stability of the relative position of the substrate layer 227 and the second flexible conductor layer 229. The second adhesive layer 228 is provided with a first opening 2281 at a position corresponding to the electrical connection portion 2271, and the second adhesive layer 228 is provided with a second opening 2282 at a position corresponding to the first conductive through hole 2273, so that the second adhesive layer 228 can be prevented from blocking the electrical connection portion 2271 and the first conductive through hole 2273, so as to ensure the smooth construction of the electrical connection path.

[0070] On the basis that the flexible electrode 22 also includes a back film layer 231, further, a third adhesive layer 230 may be provided between the back film layer 231 and the second flexible conductor layer 229, and the third adhesive layer 230 is used to bond the back film layer 231 and the second flexible conductor layer 229, which is conducive to improving the stability of the relative position of the back film layer 231 and the second flexible conductor layer 229. Among them, the third adhesive layer 230 is provided with a third opening 2301 at a position corresponding to the first through hole 2311, and the third adhesive layer 230 is provided with a fourth opening 2302 at a position corresponding to the second through hole 2312, so that the third adhesive layer 230 can be prevented from blocking the connection point between the flexible electrode 22 and the two wires 40a, 40b, so as to ensure the smooth construction of the electrical connection path. In the embodiment in which the first through hole 2311 and the second through hole 2312 are covered with metal by a deposition process in the subsequent process, it is also conducive to the smooth progress of the subsequent deposition process.

[0071] In some embodiments of the present disclosure, Figure 3As shown, the flexible electrode 22 may also include a coating layer 221, which is arranged on the side of the flexible metal electrode layer 223 facing away from the lining layer 224. The coating layer 221 is made of a flexible insulating material. For example, the material of the coating layer 221 may be polyimide (PI), polyethylene terephthalate (PET), polyurethane (PU) or a combination thereof. In this embodiment, by introducing the coating layer 221, the coating layer 221 can provide electrical insulation protection and mechanical protection for the first surface, isolating the electrical interference source in the external environment from the flexible metal electrode layer 223 to reduce the risk of short circuit. Due to the fact that the coating layer 221 is made of a flexible insulating material, after the coating layer 221 is introduced, the flexible electrode 22 as a whole still has good flexibility, so that the problem of large resistance encountered by the radiofrequency ablation catheter 100 using the flexible electrode 22 during the intervention of the human body can still be improved.

[0072] The coating layer 221 is provided with a first window 2211 and a second window 2212, wherein the first window 2211 exposes the power connection area, and the second window 2212 exposes the radio frequency conduction area. In this way, except for the power connection area and the radio frequency conduction area, the other areas of the flexible metal electrode layer 223 are protected by the coating layer 221. On the one hand, it is helpful to prevent the coating layer 221 from hindering the connection between the power connection area and the radio frequency cable, and on the other hand, the output range of the radio frequency energy is limited to the radio frequency conduction area, that is, the action area of ​​the radio frequency ablation can be limited. Among them, the length of the second window 2212 can be, for example, 8 mm, and the width can be, for example, 4 mm, which means that the size of the radio frequency ablation area of ​​the flexible electrode 22 is approximately 4 mm×8 mm.

[0073] In this embodiment, the far end of the RF cable can be directly extended to the first window 2211 to connect to the power connection area, or a deposition process can be used to deposit a conductive metal material (such as gold, silver, platinum, copper) on the first window 2211 and the second window 2212. Taking the gold plating of the first window 2211 and the second window 2212 as an example, the front view of the obtained flexible electrode 22 is as follows: Figure 8 As shown, the gold-plated layer 233c corresponding to the first window 2211 and the gold-plated layer 233d corresponding to the second window 2212 are exposed on the front side and the surrounding environment of the flexible electrode 22. By depositing and forming the plating layer on the first window 2211 and the second window 2212, it is helpful to reduce the possibility of the power connection area and the radio frequency conduction area being exposed and oxidized by air to form an oxide layer, thereby helping to reduce the contact resistance, improve the radio frequency energy conduction efficiency, and enhance the ablation effect.

[0074] On the basis that the flexible electrode 22 also includes a coating layer 221, further, a fourth adhesive layer 222 may be provided between the coating layer 221 and the flexible metal electrode layer 223, and the fourth adhesive layer 222 is used to bond the coating layer 221 and the flexible metal electrode layer 223, which is conducive to improving the stability of the relative position of the coating layer 221 and the flexible metal electrode layer 223. Among them, the fourth adhesive layer 222 is provided with a fifth opening 2221 at the position corresponding to the first window 2211, and the fourth adhesive layer 222 is provided with a sixth opening 2222 at the position corresponding to the second window 2212, so that the fourth adhesive layer 222 can avoid blocking the electrical connection area and the RF conduction area, which is conducive to ensuring that the RF conduction area can output RF current, and is conducive to the RF cable and the electrical connection area. In the embodiment where the first window 2211 and the second window 2212 are covered with metal by a deposition process, it is also conducive to the smooth progress of the subsequent deposition process.

[0075] In some embodiments of the present disclosure, the total thickness of the flexible electrode 22 can be configured to be less than or equal to 0.2 mm. The total thickness of the flexible electrode 22 can be selected from any value of 0.15 mm, 0.16 mm, 0.17 mm, 0.18 mm, 0.19 mm, and 0.2 mm. Through such a design, the overall thickness of the flexible electrode 22 is relatively small, which is conducive to making the volume of the radiofrequency ablation catheter 100 equipped with the flexible electrode 22 smaller when it intervenes in the human body, which can have a favorable effect on reducing the intervention resistance of the radiofrequency ablation catheter 100. Moreover, because the overall thickness of the flexible electrode 22 is relatively small, the flexible electrode 22 has higher adaptability and can withstand more bending times, and can then be deformed more times with the expansion and contraction of the support carrier 10, so as to help extend the service life.

[0076] The first conductive via 2273 and the second conductive via 2272 herein can be formed by a through-silicon via (TSV) process or a copper plug process, and this embodiment does not impose any specific restrictions on this. As disclosed herein, each adhesive layer (i.e., the first adhesive layer 225, the second adhesive layer 228, the third adhesive layer 230, and the fourth adhesive layer 222) can be any one of epoxy resin, hot melt adhesive, polyurethane adhesive, acrylic adhesive, butyl adhesive, etc.

[0077] Please refer to Figure 1 and Figure 2As shown, the embodiment of the present disclosure also provides a radiofrequency ablation catheter 100, including an expandable support carrier 10 and a flexible electrode assembly 20, wherein the flexible electrode assembly 20 includes one or more flexible electrodes 22 described in any of the aforementioned embodiments, and each flexible electrode 22 is attached to the support carrier 10. As described above, the support carrier 10 may be, but is not limited to, a memory metal component and a balloon 11. The distal end of the radiofrequency ablation catheter 100 can be deformed to a smaller volume, so as to reduce the resistance encountered during the intervention into the human body.

[0078] In some embodiments of the present disclosure, Figure 1 and Figure 2 As shown, the radiofrequency ablation catheter 100 may also include a tube body 30, the support carrier 10 is a balloon 11, and the proximal end of the balloon 11 is arranged on the tube body 30. The tube body 30 is not only used to carry the balloon 11, but also the internal lumen thereof can be used for the passage of radiofrequency cables and wires. The flexible electrode assembly 20 may include a fixing ring 21 and a plurality of flexible electrodes 22, the fixing ring 21 is sleeved on the outer periphery of the proximal shaft section of the balloon 11, each flexible electrode 22 is connected to the fixing ring 21, the distal end and the proximal end of each flexible electrode 22 are respectively located on both sides of the fixing ring 21 along its own axial direction, the parts of each flexible electrode 22 located on the distal side of the fixing ring 21 are independent of each other, and the part of each flexible electrode 22 located on the distal side of the fixing ring 21 forms an ablation terminal, and the part of each flexible electrode 22 located on the proximal side of the fixing ring 21 has at least two common lining layers 224 and substrate layers 227 to form a connection terminal. In this way, the flexible electrode assembly 20 has multiple ablation terminals and at least one connecting terminal. The number of ablation terminals is the same as the number of flexible electrodes 22. The ablation terminals are attached to the balloon 11 by bonding or the like. The connecting terminals can extend into the lumen of the tube body 30 to connect with the wires and radio frequency cables passing through the lumen.

[0079] Fig. 9 FIG. 2 is a schematic diagram of the structure of the flexible electrode assembly 20 in some embodiments of the present disclosure. Fig. 9 As shown, the flexible electrode assembly 20 includes four flexible electrodes 22, and the parts of the four flexible electrodes 22 located on the far side of the fixing ring 21 each form an ablation terminal, and the four ablation terminals are independent of each other, and the parts of every two flexible electrodes 22 located on the near side of the fixing ring 21 share a lining layer 224 and a substrate layer 227 to form a connection terminal. Of course, in other embodiments of the present disclosure, the number of flexible electrodes 22 included in the flexible electrode assembly 20 can be 2, 3, 5, etc., which can be reasonably designed according to the needs.

[0080] In this embodiment, multiple flexible electrodes 22 are formed into a flexible electrode assembly 20 by means of an integrated design. The flexible electrode assembly 20 is an integrated component with a compact structure, which is convenient for standardized manufacturing and production. Compared with installing all flexible electrodes 22 one by one on the balloon 11, in this embodiment, the assembly links of the flexible electrode assembly 20 and the balloon 11 are reduced, which is conducive to improving assembly efficiency. Moreover, the connection points of each flexible electrode 22 and the radio frequency cable and the two wires 40a and 40b in the multiple flexible electrodes 22 sharing the lining layer 224 and the substrate layer 227 are more concentrated, which is convenient for wiring.

[0081] In some embodiments of the present disclosure, Figure 1 and Fig. 9 As shown, the flexible electrode assembly 20 includes a plurality of flexible electrodes 22, the distal ends of all the flexible electrodes 22 are evenly and spaced around the longitudinal axis of the balloon 11, and the distal ends of all the flexible electrodes 22 are sequentially distributed along the longitudinal axis of the balloon 11 from the proximal end to the distal end of the balloon 11. In other words, the distal ends of the flexible electrodes 22 are sequentially arranged along a spiral curve on the surface of the balloon 11, and the normal distance between the distal ends of the flexible electrodes 22 and the distal end of the tube body 30 gradually increases. In this embodiment, by optimizing the layout of the distal ends of the plurality of flexible electrodes 22, the distribution of the RF energy can be effectively optimized.

[0082] The embodiment of the present disclosure also provides a radiofrequency ablation system, including a radiofrequency device and a radiofrequency ablation catheter 100 of any of the above embodiments, wherein the proximal end of the radiofrequency cable of the radiofrequency ablation catheter 100 is connected to the radiofrequency device. The radiofrequency ablation system can be used not only to treat arrhythmias, but also to treat diseases such as tumors. When the radiofrequency ablation system is used to ablate the target tissue of a patient, the distal end of the radiofrequency ablation catheter 100 can be deformed to a smaller volume, so as to reduce the resistance encountered during the intervention into the human body.

[0083] It should be understood that in this specification, the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential" and the like indicate orientations or positional relationships or dimensions that are based on the orientations or positional relationships or dimensions shown in the accompanying drawings, and these terms are used only for the convenience of description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the scope of protection of the present disclosure.

[0084] In addition, the terms "first", "second", "third", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first", "second", "third" may explicitly or implicitly include one or more of the feature. In the description of the present disclosure, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0085] In the present disclosure, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection, or a communication; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present disclosure can be understood according to specific circumstances.

[0086] In the present disclosure, unless otherwise expressly specified and limited, a first feature being “above” or “below” a second feature may include that the first and second features are in direct contact, or may include that the first and second features are not in direct contact but are in contact through another feature between them. Moreover, a first feature being “above”, “above”, and “above” a second feature includes that the first feature is directly above and obliquely above the second feature, or simply indicates that the first feature is higher in level than the second feature. A first feature being “below”, “below”, and “below” a second feature includes that the first feature is directly below and obliquely below the second feature, or simply indicates that the first feature is lower in level than the second feature.

[0087] This specification provides many different embodiments or examples that can be used to implement the present disclosure. It should be understood that these different embodiments or examples are purely exemplary and are not intended to limit the scope of protection of the present disclosure in any way. Those skilled in the art can conceive of various changes or replacements based on the disclosure of the present specification, which should all be included in the scope of protection of the present disclosure. Therefore, the scope of protection of the present disclosure should be based on the scope of protection defined by the attached claims.

Claims

1. A flexible electrode for a radiofrequency ablation catheter, characterized in that: The flexible electrode comprises: A flexible metal electrode layer, having a first surface and a second surface opposite to the first surface along its thickness direction, wherein the power connection area of ​​the flexible metal electrode layer is used to connect to the distal end of the radio frequency cable of the radio frequency ablation catheter, and the distal end of the flexible metal electrode layer has a radio frequency conduction area, and the radio frequency conduction area is configured to conduct radio frequency energy to the target tissue; A lining layer is arranged on the second surface, and the lining layer is made of a flexible insulating material; A first flexible conductor layer is stacked on a side of the liner layer facing away from the flexible metal electrode layer, and the first flexible conductor layer and the flexible metal electrode layer are insulated and isolated by the liner layer; A substrate layer, arranged on a side of the first flexible conductor layer facing away from the flexible metal electrode layer, an electrical connection portion is arranged at a distal end of the substrate layer, and the substrate layer is made of a flexible insulating material; A second flexible conductor layer is stacked on a side of the substrate layer facing away from the flexible metal electrode layer, the second flexible conductor layer and the first flexible conductor layer are insulated and isolated by the substrate layer, the distal end of the second flexible conductor layer is electrically connected to the distal end of the first flexible conductor layer through the electrical connection portion, and the orthographic projection of the connection between the distal end of the first flexible conductor layer and the distal end of the second flexible conductor layer and the electrical connection portion on the first surface falls within the radio frequency conduction area, and the proximal end of the second flexible conductor layer and the proximal end of the first flexible conductor layer are used to be respectively connected to the distal ends of the two wires of the radio frequency ablation catheter to form a thermocouple loop.

2. The flexible electrode according to claim 1, characterized in that: The proximal end of the first flexible conductor layer has a first connection area, and the first connection area is connected to one of the two wires; the proximal end of the second flexible conductor layer has a second connection area, and the second connection area is used to connect to the other of the two wires; The orthographic projections of the first connection area and the second connection area on the first surface are staggered, and the orthographic projection of the first connection area on the first surface does not fall within the orthographic projection area of ​​the second flexible conductor layer on the first surface.

3. The flexible electrode according to claim 2, characterized in that: The orthographic projection of the first flexible conductor layer on the first surface falls within the boundary of the orthographic projection area of ​​the substrate layer on the first surface, and the proximal end of the substrate layer exceeds the proximal end of the second flexible conductor layer in its own extension direction; A first conductive through hole is provided at the proximal end of the substrate layer. The first conductive through hole is provided at a portion of the substrate layer that exceeds the proximal end of the second flexible conductor layer. The first connection area is connected to one of the two wires through the first conductive through hole.

4. The flexible electrode according to claim 3, characterized in that: It also includes a back film layer stacked on the side of the second flexible conductor layer facing away from the flexible metal electrode layer, the side of the back film layer facing away from the flexible metal electrode layer is used to connect with the support carrier of the radio frequency ablation catheter, and the back film layer is made of a flexible insulating material; The proximal end of the back film layer is provided with a first through hole and a second through hole spaced apart from each other, the first through hole is used to expose the connection point between the first conductive via and one of the two wires, and the second through hole is used to expose the connection point between the second connection area and the other of the two wires.

5. The flexible electrode according to claim 4, characterized in that: It also includes a conductive layer, the conductive layer and the second flexible conductor layer are arranged in the same layer, the conductive layer and the proximal end of the second flexible conductor layer are adjacent and spaced apart, and the first conductive through hole is connected to one of the two wires through the conductive layer; And / or, the proximal end of the back film layer is in a rectangular shape, and the first through hole and the second through hole are arranged at two ends of a diagonal line of the rectangle along its own extending direction.

6. The flexible electrode according to claim 1, characterized in that: It also includes a coating layer, which is arranged on the side of the flexible metal electrode layer facing away from the lining layer. The coating layer is provided with a first window and a second window. The first window exposes the power connection area, and the second window exposes the radio frequency conduction area. The coating layer is made of a flexible insulating material.

7. The flexible electrode according to claim 5, characterized in that: The electrical connection portion is a second conductive through hole, and the second conductive through hole penetrates the thickness of the distal end of the substrate layer.

8. The flexible electrode according to any one of claims 1 to 7, characterized in that: The total thickness of the flexible electrode is less than or equal to 0.2 mm.

9. A radiofrequency ablation catheter, characterized in that: include: An expandable support carrier and a flexible electrode assembly, wherein the flexible electrode assembly comprises one or more flexible electrodes as claimed in any one of claims 1 to 8, and the flexible electrodes are attached to the support carrier.

10. The radiofrequency ablation catheter according to claim 9, characterized in that: It also includes a tube body, the support carrier is a balloon, and the proximal end of the balloon is arranged on the tube body; The flexible electrode assembly comprises: A fixing ring, sleeved on the outer circumference of the proximal shaft section of the balloon; and Multiple flexible electrodes are all connected to the fixing ring, and the distal end and proximal end of any flexible electrode are respectively located on both sides of the fixing ring along its axial direction, the parts of each flexible electrode located on the distal side of the fixing ring are independent of each other and attached to the balloon, and there are at least two parts of each flexible electrode located on the proximal side of the fixing ring that share the lining layer and the base plate layer and extend into the lumen of the tube body.

11. The radiofrequency ablation catheter according to claim 9, characterized in that: The supporting carrier is a balloon, and the flexible electrode assembly includes a plurality of the flexible electrodes, the distal ends of all the flexible electrodes are evenly and spaced apart around the longitudinal axis of the balloon, and the distal ends of all the flexible electrodes are distributed in sequence from the proximal end to the distal end of the balloon along the longitudinal axis of the balloon.

12. A radiofrequency ablation system, characterized in that: include: A radio frequency device and a radio frequency ablation catheter according to any one of claims 9 to 11, wherein the proximal end of a radio frequency cable of the radio frequency ablation catheter is connected to the radio frequency device.

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