CN118000888A

CN118000888A - Ablation catheter and ablation system

Info

Publication number: CN118000888A
Application number: CN202211406153.7A
Authority: CN
Inventors: 李亚斌; 刘成
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2022-11-10
Filing date: 2022-11-10
Publication date: 2024-05-10

Abstract

The application discloses an ablation catheter and an ablation system. The ablation catheter comprises a catheter body and an ablation assembly, the ablation assembly comprises a conductive framework and at least one electrode arranged on the conductive framework, the conductive framework is arranged at the far end of the catheter body, the conductive framework and the at least one electrode are insulated from each other, the conductive framework can be connected with one pole of an energy generator, and at least one electrode can be connected with the other pole of the energy generator so as to transmit ablation energy output by the energy generator to a target tissue region through the cooperation of the conductive framework and the at least one electrode. The ablation catheter adopts a bipolar ablation mode of matching the conductive framework with the electrode on the conductive framework, so that not only can the stimulation to an ablation object be reduced, but also the ablation damage depth of the target tissue area for ablation can be improved, and the ablation catheter has a good ablation effect.

Description

Ablation catheter and ablation system

Technical Field

The application relates to the technical field of medical instruments, in particular to an ablation catheter and an ablation system.

Background

Complex atrial fibrillation refers to atrial fibrillation that is not curable by single pulmonary vein isolation, and essentially belongs to persistent atrial fibrillation, but the trigger factor is other complex factors besides pulmonary veins. Ablation catheters are a relatively common method for treating atrial fibrillation, including radiofrequency ablation, cryoablation, and pulse ablation. For the ablation of continuous atrial fibrillation, a 'stepwise' ablation strategy is generally adopted in China at present, namely, the electrical isolation of the bilateral pulmonary veins vestibule of the ring and the ablation of the top line, the mitral isthmus line and the tricuspid isthmus line are relatively fixed, and the implementation is relatively simple.

The problem of the ablation of the treatment position of persistent atrial fibrillation at present is that the reduction of the stimulation of the body and the ablation depth are difficult to achieve, the conventional ablation mode is accompanied by the influence on the stimulation of the body of a patient under the condition of meeting the requirement of the ablation depth, the aorta and the esophagus of the patient are easy to be damaged, and the requirement of the ablation depth is difficult to meet under the ablation mode of reducing the stimulation.

Disclosure of Invention

In view of the above, the present application provides an ablation catheter and an ablation system to solve the problems of insufficient ablation depth and large stimulation to an ablation object during the ablation process.

In a first aspect, the present application provides an ablation catheter comprising:

A catheter body;

An ablation assembly comprising a conductive backbone and at least one electrode disposed on the conductive backbone, the conductive backbone disposed at a distal end of the catheter body, the conductive backbone and at least one of the electrodes insulated from each other;

Wherein the conductive skeleton is connectable to one pole of an energy generator, at least one of the electrodes is connectable to another pole of the energy generator to deliver ablative energy output by the energy generator to a target tissue region through cooperation of the conductive skeleton and at least one of the electrodes.

In a second aspect, the present application provides an ablation system comprising: a pulse ablation device and an ablation catheter according to any preceding claim, the ablation catheter being connected to the pulse ablation device.

The ablation catheter provided by the embodiment of the application comprises a catheter main body and an ablation assembly, wherein the ablation assembly comprises a conductive framework and at least one electrode arranged on the conductive framework, the conductive framework is arranged at the distal end of the catheter main body, and the conductive framework and the at least one electrode are insulated from each other. Wherein the conductive skeleton is connectable to one pole of the energy generator and the at least one electrode is connectable to another pole of the energy generator to deliver ablative energy output by the energy generator to the target tissue region through cooperation of the conductive skeleton and the at least one electrode. On the one hand, the conductive framework and the electrodes on the conductive framework are used as positive and negative electrodes to form a large-area overall electrode, so that a large-range electric field can be generated between the electrodes and the conductive framework, and further, the conductive framework can be attached to the tissue wall after being radially expanded, so that the generated large-range electric field can cover a region within a certain range from the tissue wall, thereby forming deeper ablation damage and improving the ablation effect of pathological tissues. On the other hand, the positive electrode and the negative electrode are ablated by utilizing the conductive framework and the electrode on the conductive framework, and compared with a negative electrode plate, most of current formed between the positive electrode and the negative electrode only exists near the conductive framework and does not flow through skeletal muscles in the back and other areas, so that the body stimulation to an object to be ablated is reduced.

Drawings

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

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

FIG. 2 is a schematic view of an ablation catheter from a first perspective according to a first embodiment of the application;

FIG. 3 is a schematic structural view of the ablation catheter of FIG. 2 at a second view angle;

FIG. 4 is a schematic illustration of a scenario in which the ablation catheter of FIG. 2 is used to perform an operation on a human heart;

FIG. 5 is a simulated schematic diagram of the electric field distribution of the ablation catheter of FIG. 2;

FIG. 6 is a schematic view of an ablation catheter from a first perspective provided by a second embodiment of the application;

FIG. 7 is a schematic structural view of the ablation catheter of FIG. 6 at a second view angle;

FIG. 8 is a schematic structural view of the ablation catheter of FIG. 6 at a third view angle;

fig. 9 is a schematic view of an ablation catheter from a first perspective provided by a third embodiment of the application;

FIG. 10 is a schematic structural view of the ablation catheter of FIG. 9 at a second view angle;

The reference numerals are explained as follows:

100. An ablation system;

10. An ablation catheter; 1. a catheter body; 2. an ablation assembly; 21. a conductive skeleton; 211. a carrier bar; 2111. a first carrier bar; 2112. a second carrier bar; 2113. an outermost end; 212. a first connection frame; 2121. a connecting rod; 21211. a first connecting rod; 21212. a second connecting rod; 21213. a recessed portion; 212131, a bending section; 212132, a central section; 213. a second connection frame; 2131. a support post; 2132. a grid structure; 2133. a grid set; 2134. connecting grids; 21341. a first connection grid; 21342. a second connection grid; 2135. a main grid; 21351. a first primary grid; 21352. a second primary grid; 22. an electrode; 221. a first electrode; 2211. a first ring shape; 222. a second electrode; 2221. a second ring shape; 223. a third electrode; 2231. a third ring shape; 3. a reference electrode; 4. a head electrode;

20. a conveying device;

20a, an ablation line;

20b, mapping lines;

30. a pulse ablator;

40. A wiring board;

50. a three-dimensional mapping system;

60. A multi-guide recorder.

Detailed Description

The following description of the embodiments of the present application will be made clearly and completely with reference to the accompanying drawings, in which it is apparent that the embodiments described are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the application without making any inventive effort, are intended to be within the scope of the application.

In the interventional medical field, the end of the instrument near the operator is generally referred to as a proximal end and the end of the instrument far from the operator is generally referred to as a distal end along the transport path of the instrument. In particular, for delivery devices used to deliver and release an implantable device into a patient, the distal end refers to the end of the delivery device that is free to be inserted into an animal or human body, and the proximal end refers to the end of the delivery device that is intended for manipulation by a user or machine.

The term "axial" generally refers to the longitudinal direction of the medical device as it is delivered, the term "radial" generally refers to the direction of the medical device perpendicular to its "axial direction," and the term "circumferential" generally refers to the direction about the "axial direction," with the "axial", "radial" and "circumferential" directions of the relevant components of the ablation catheter being defined herein in accordance with this principle. The definitions are provided for convenience of description and are not to be construed as limiting the application. With the exception of a few, reasonable explanations can be made in connection with the accompanying drawings and the general understanding of those skilled in the art.

It is to be understood that the terminology used in the description and claims of the application and in the above description and drawings is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. The terms first, second and the like in the description and in the claims and in the above-described figures, are used for distinguishing between different objects and not necessarily for describing a sequential or chronological order. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprising" and any variations thereof is intended to cover a non-exclusive inclusion. Furthermore, the present application may be embodied in many different forms and is not limited to the embodiments described in the present embodiment. The following specific examples are provided to facilitate a more thorough understanding of the present disclosure, in which terms indicating orientations of the components, up, down, left, right, etc., are merely for the locations of the illustrated structures in the corresponding drawings.

The description is then made of the preferred embodiments for carrying out the application, however, the foregoing description is for the purpose of illustrating the general principles of the application and is not meant to limit the scope of the application. The scope of the application is defined by the appended claims.

First embodiment

Referring to fig. 1, fig. 1 is a schematic structural diagram of an ablation system 100 according to the present application.

The ablation system 100 may include a pulse ablation device and an ablation catheter 10, wherein the pulse ablation device may include a pulse ablator 30, a patch panel 40, a three-dimensional mapping system 50, and a multi-guide recorder 60. Ablation catheter 10 is connected to pulse ablator 30 by ablation line 20a and mapping line 20b, and mapping line 20b is also connected to patch panel 40, three-dimensional mapping system 50, and multi-guide recorder 60, respectively.

The pulse ablator 30 may include, among other things, a user interface, an energy generator, a data storage module, and a controller. Wherein the user interface is used to indicate information such as various operations of the pulse ablator 30 for use by an operator. The energy generator is for emitting pulsed ablation energy. The data storage module stores executable instructions for performing the operations described in this embodiment in conjunction with the controller. Under the three-dimensional mapping image, an operator can operate the pulse ablation instrument 30 to control the ablation catheter 10 to reach a low-voltage area or a focus of the heart of the patient, and precisely ablate the focus, so that the conduction of abnormal electric signals is blocked.

The three-dimensional mapping system 50 employs electric field modeling in combination with electrocardiography mapping to construct a heart model. The electric field modeling is realized through body surface leads, wherein the body surface leads are electrodes attached to all parts of the body so as to form orthogonal electric fields and generate a body surface electrocardiogram. After the ablation catheter 10 enters the orthogonal electric field, a loop is formed with the internal circuit of the three-dimensional mapping system 50, so that a three-dimensional model is formed. In addition, the ablation catheter 10 may also collect electrocardiographic signals, and combine the electrocardiographic signals with the three-dimensional model to form a complete heart model. The three-dimensional mapping system 50 may also incorporate computed tomography (Computer tomography, CT) image data, digital subtraction angiography (Digital subtraction angiography, DSA) image data to modify the heart model. The multi-guide recorder 50 may include a storage unit, a processing unit, and a display interface (not shown in the figure), where the storage unit is configured to receive cardiac electrical signals from a patient, the processing unit is configured to analyze cardiac electrical signals to generate images such as corresponding excitation patterns, voltage patterns, and the like, and the display interface is configured to display images such as excitation patterns, voltage patterns, and the like, so as to direct the operator of the location of the focal area and the low voltage area of the heart of the patient.

In this embodiment, only the cardiac model constructed by the body surface leads and the ablation catheter 10 contains a lot of noise, and the coordinate values of the image in the cardiac model can be corrected by inputting the computed tomography image data and the digital subtraction angiography image as data and combining the algorithm to form a finer cardiac model image, so that an operator can control the ablation catheter 10 to perform ablation better.

Referring to fig. 1 and 3 together, fig. 1 is a schematic structural diagram of an ablation catheter 10 according to a first embodiment of the present application, and fig. 3 is a schematic view of a scenario in which the ablation catheter 10 in fig. 1 performs an operation on a human heart. The ablation catheter 10 includes a catheter body 1, and an ablation assembly 2 disposed at a distal end of the catheter body 1, the ablation catheter 10 being deliverable to the interior of the heart by a delivery device 20, which may generally comprise a sheath, handle, etc., and reference is made to the relevant art for the specific construction of the delivery device.

It should be understood by those skilled in the art that the illustrated figure 1 is merely an example of an ablation catheter 10 and is not intended to be limiting of the ablation catheter 10, and that the ablation catheter 10 may include more or fewer components than illustrated in figure 1, or may incorporate certain components, or different components, such as the ablation catheter 10 may also include temperature sensors, etc. The temperature sensor is used to detect the temperature of the target tissue during ablation to prevent the temperature from being too low or too high.

The catheter body 1 is constructed as a hollow tubular structure. The central axis L of the catheter body 1 extends in the distal and proximal directions. The catheter body 1 has a single axial lumen or central lumen (not shown) therein. The catheter body 1 may also have multiple lumens to accommodate wires, leads, sensor cables, and any other wire, cable, and/or tube structures that may be needed in a particular application, as desired.

It will be appreciated that the catheter body 1 may also be of any suitable construction and may be made of any suitable material, for example one construction comprising an outer wall made of a polymeric material such as polyurethane or polyether block amide (polyether block amide, PEBAX). The catheter body 1 has a certain flexibility and is bendable to adapt to a bending structure inside the heart. The diameter of the catheter body 1 is approximately 8F. The dimensions of the catheter main body 1 are merely for explanation, and are not particularly limited.

The ablation assembly 2 includes a radially contractible and expandable conductive skeleton 21 and at least one electrode 22 disposed on the conductive skeleton 21.

The proximal end of the conductive skeleton 21 is connected to the distal end of the catheter body 1, and the distal end of the conductive skeleton 21 is folded toward the axis L of the catheter body 1. Fig. 1 illustrates a structure in which the conductive frame 21 is in an expanded state, and at this time, both ends of the conductive frame 21 are folded and the middle part is expanded, and the outline of the conductive frame 21 is substantially in a basket shape. The conductive skeleton 21 may also be of other configurations, such as spherical, egg-shaped, pumpkin-shaped, lantern-shaped, oval-shaped, etc.

Based on the structure illustrated in fig. 1, the conductive skeleton 21 may be contracted radially inward with respect to the axis L of the catheter main body 1, that is, the middle portion of the conductive skeleton 21 is also contracted in the direction of the axis L of the catheter main body 1, and the conductive skeleton 21 will straighten to a substantially linear state in the contracted state. The conductive backbone 21 will have an axial length in the contracted state that is greater than its axial length in the expanded state.

In the contracted state, the conductive frame 21 may be accommodated in the conveying device 20 to be conveniently conveyed into the human body through the conveying device 20. When the target ablation site is reached by the delivery device 20, the conductive framework 21 is released from the delivery device 20 and radially expanded to the expanded state shown in fig. 1.

The conductive framework 21 may be self-expanding to expand as it extends out of the delivery device 20, or the conductive framework 21 may be radially expanded under artificial steering intervention after extending out of the delivery device 20.

The conductive framework 21 can be made of elastic metal pipe by cutting, can be made of elastic metal wire by weaving, or can be processed by combining local weaving and local pipe cutting, and different parts can be welded or mutually fixed through connecting pieces. The material of the pipe is metal or nonmetal material, preferably memory metal material or nickel-titanium alloy material. In this embodiment, the conductive frame 21 may be formed by cutting and shaping a nickel-titanium alloy tube.

Specifically, the conductive skeleton 21 includes a plurality of carrier bars 211 arrayed circumferentially about the axis L of the catheter main body 1; the plurality of load bars 211 are enclosed in a radially collapsible and expandable structure. In the present embodiment, the carrier bars 211 are provided nine in the circumferential direction around the axis L of the catheter main body 1, and the carrier bars 211 are uniformly arranged in the circumferential direction. In other embodiments, the number of load bars 211 may be four, five, six, seven, eight, ten, eleven, twelve, or any other suitable number. The load bars 211 may be uniformly or non-uniformly circumferentially spaced.

The proximal ends of the respective carrier bars 211 are connected to the distal ends of the catheter main body 1, and the distal ends of the plurality of carrier bars 211 are folded toward the axis L direction of the catheter main body 1 and fixed to each other.

The electrode 22 is disposed on the carrier bar 211 of the conductive skeleton 21. After radial expansion of the conductive skeleton 21, each of the load bars 211 may be brought into contact with the inner wall of the tissue inside the heart, and the electrodes 22 may be used for tissue ablation using ablation energy. The electrode 22 is disposed on the conductive frame 21, and the electrode 22 does not change in position with the expansion of the conductive frame 21 during the radial expansion of the conductive frame 21.

Each carrying rod 211 is provided with at least one electrode 22, the plurality of electrodes 22 form at least one ring shape in the circumferential direction of the conductive framework 21, and the plane of the ring shape is perpendicular to the central axis of the conductive framework 21, so that the ablation can be more uniform when the electrode 22 is adopted to ablate a target tissue region, and the potential can be more easily mapped when the electrode 22 is adopted to map the target tissue region.

In the present embodiment, the plurality of load bars 211 includes a plurality of first load bars 2111 and a plurality of second load bars 2112. At least two second bearing bars 2112 are provided between two adjacent first bearing bars 2111, and the first bearing bars 2111 and the second bearing bars 2112 are provided with different numbers of electrodes 22, respectively.

Specifically, in the present embodiment, the plurality of first carrier bars 2111 and the plurality of second carrier bars 2112 are provided with a plurality of electrodes 22, the plurality of electrodes 22 include a plurality of first electrodes 221, a plurality of second electrodes 222 and a plurality of third electrodes 223, each first carrier bar 2111 is provided with a first electrode 221, a second electrode 222 and a third electrode 223 at intervals from distal end to proximal end along the axial direction, each second carrier bar 2112 is provided with a second electrode 222 and a third electrode 223 at intervals from distal end to proximal end along the axial direction, the plurality of first electrodes 221 are formed with a first ring shape 2211 in the circumferential direction of the conductive framework 21, the plurality of second electrodes 222 are formed with a second ring shape 2221 in the circumferential direction of the conductive framework 21, the plurality of third electrodes 223 are formed with a third ring shape 2231 in the circumferential direction of the conductive framework 21, and planes of the first ring shape 2211, the second ring shape 2221 and the third ring shape 2231 are parallel to each other and are perpendicular to the central axis of the conductive framework 21.

It is understood that in some embodiments, the plurality of electrodes 22 may also include a plurality of fourth electrodes, a plurality of fifth electrodes, …, and a plurality of nth electrodes, where N is an integer greater than 3. The plurality of fourth electrodes form a fourth ring shape in the circumferential direction of the conductive frame 21, the plurality of fifth electrodes form a fifth ring shape in the circumferential direction of the conductive frame 21, and the plurality of nth electrodes form an nth ring shape in the circumferential direction of the conductive frame 21. The number of loops of the conductive skeleton 21 is for illustration only and is not particularly limited. The radial dimensions of the plurality of loops gradually increase from the distal end of the conductive skeleton 21 toward the proximal end.

In this embodiment, the plurality of electrodes 22 disposed on the conductive skeleton 21 form three rings, in the fully released state of the conductive skeleton 21, including the third ring 2231 close to the catheter body 1, the first ring 2211 far from the catheter body 1, and the second ring 2221 between the first ring 2211 and the second ring 2231, the second ring 2231 includes the second electrode 222 and the third ring 2231 includes the third electrode 223 disposed on the first bearing rod 2111 and the second bearing rod 2112, and the first ring 2211 includes the first electrode 221 disposed on the first bearing rod 2111 only, the purpose of this arrangement is that the second ring 2221 and the third ring 2231 form a double-layer ablation, which can make the ablation more uniform, and the potential is also easily mapped, and since the first ring 2211 is close to the distal end of the conductive skeleton 21, only a small amount of the first electrode 221 is disposed at a position close to the distal end of the conductive skeleton 21 for the convenience of sheath, so that a sufficient space can be vacated, which is convenient for sheath retraction.

The positions of the carrier bars 211 farthest from the axis L of the catheter body 1 in the radial direction are referred to as outermost ends 2113, respectively, and the electrode 22 provided on the first carrier bar 211 of the present embodiment may be disposed between the distal end of the carrier bar 211 and the outermost ends 2113. Because the electrode 22 is disposed on the carrying bar 211 near the distal end, and the carrying bar 211 near the distal end is mainly used for performing the abutting ablation with the target tissue region, it is ensured that the electrode 22 has good adhesion and compliance with the target tissue region, thereby being beneficial to the ablation of the target tissue region.

It should be noted that, at the position where the electrode 22 is disposed on the carrier bar 211, an insulation treatment is required to insulate the carrier bar 211 and the electrode 22 at the position from each other, for example, an insulation coating material is applied at the position where the insulation treatment is required, and the coating material includes, but is not limited to, a parylene coating, a PTFE (polytetrafluoroethylene) coating, a PI (Polyimide) coating; or covering an insulating film at a position to be subjected to an insulating treatment, wherein film materials include, but are not limited to, FEP (Fluorinated-Ethylene-propylene copolymer), PU (Polyurethane), ETFE (Ethylene-tetra-fluoro-Ethylene, ethylene-tetrafluoroethylene copolymer), PFA (Polyfluoroalkoxy, tetrafluoroethylene-perfluoroalkoxy vinyl ether copolymer), PTFE, PEEK (Poly-ether-ether-ketone), and silicone; or the insulating sleeve is sleeved at the position needing insulating treatment, and the materials of the insulating sleeve comprise, but are not limited to FEP, PU, ETFE, PFA, PTFE, PEEK and silica gel.

In this embodiment, the electrode 22 may be made of medical metal such as platinum, iridium, gold, silver, etc. and may be a cylindrical electrode sheet, one of the circular surfaces of the electrode sheet is attached to the outer surface of the carrier 211, and it is understood that the shape of the electrode 22 is not limited in this embodiment, and the electrode 22 may be an annular electrode, a dot electrode, a spherical electrode, etc.

Each electrode 22 on the carrying bar 211 is connected to an energy generator outside the ablation catheter 10 by a wire (not shown in the drawing), specifically, one wire having an insulating layer is welded to the inner wall of each electrode 22, and one end of the wire is welded to a connector on the handle to be connected to the energy generator and to the inner wall of the electrode 22 via the inner lumen of the catheter body 1 and the inner space of the conductive skeleton 21. The electrode 22 and the wire may be connected by other special processes besides soldering. The wire can be an enameled wire, and the enameled wire has insulating property and can withstand voltage of more than or equal to 500V. After electrode 22 is wired to the energy generator, the energy generator may provide electrical pulses to electrode 22 to perform electroporation procedures. The energy generator may deliver a plurality of different various waveforms or shape pulses to the electrode 22 to effect electroporation ablation of the focal tissue, such as sinusoidal alternating current pulses, direct current pulses, square wave pulses, exponentially decaying waveforms, or other pulse-shaped electrical ablations, as well as combined alternating current/direct current pulses or direct current offset signals. The energy pulse train received by the electrode 22 comprises monophasic or biphasic pulses, and the ablation electrode may be configured with different voltage, pulse width, repetition frequency, duty cycle, and number of pulses.

In this embodiment, the conductive frame 21 is made of a metal material, which has conductivity, the conductive frame 21 can be separately connected to one pole of the energy generator, the proximal end of the conductive frame 21 is connected to the distal end of a wire by welding, and the proximal end of the wire is welded to a connector on the handle to connect to the energy generator.

When the ablation catheter 10 of the first embodiment is used to deliver ablation energy to a target tissue region, the ablation energy can be achieved by the cooperation of the conductive framework 21 and the electrode 22. Specifically, the plurality of electrodes 22 are connected to the negative electrode of the energy generator, the conductive skeleton 21 is connected to the positive electrode of the energy generator, or the plurality of electrodes 22 are connected to the positive electrode of the energy generator, the conductive skeleton 21 is connected to the negative electrode of the energy generator, and the positive and negative electrodes form a pulsed electric field to deliver ablation energy to the target tissue region.

In some embodiments, it may be selected that the partial electrodes 22 of the plurality of electrodes 22 are mated with the conductive skeleton 21, specifically, the partial electrodes 22 of the plurality of electrodes 22 are connected with the positive electrode of the energy generator, the conductive skeleton 21 is connected with the negative electrode of the energy generator, or the partial electrodes 22 of the plurality of electrodes 22 are connected with the negative electrode of the energy generator, and the conductive skeleton 21 is connected with the positive electrode of the energy generator.

In some embodiments, only the plurality of electrodes 22 may be selected to effect delivery of ablation energy to the target tissue region, i.e., at least one of the plurality of electrodes 22 is connected to a positive electrode (negative electrode) of the energy generator and the remaining at least one electrode 22 is connected to a negative electrode (positive electrode) of the energy generator. In addition, in some embodiments, at least one of the plurality of electrodes 22 may be selectively coupled to one pole of the energy generator and the other pole of the energy generator coupled to the patient-attached electrode plate; optionally, the conductive frame 21 is connected to one pole of the energy generator and the other pole of the energy generator is connected to an electrode plate attached to the patient's body surface.

While the high voltage pulse may alternatively be in the form of energy delivered by the plurality of electrodes 22 and/or conductive skeleton 21, other forms of ablation energy may be additionally or alternatively emitted, such as radiofrequency energy or any other suitable form of energy.

In some embodiments, the ablation assembly 2 may further include a head electrode 4 disposed at a distal-most end of the conductive framework 21, the head electrode 4 and the conductive framework 21 being insulated from each other, the head electrode 4 may have the function of potential mapping and/or delivering ablation energy to a target tissue region. The head electrode 4 is connected with an insulated wire, one end of which is welded to a connector on the handle, and is connected to the head electrode via the lumen of the catheter body 1 and the inner space of the conductive skeleton 21.

In some embodiments, the distal end of the carrier bar 211 has a rounded arc transition, the distal end surface of the conductive skeleton 21 has an arc surface, and the distal end surface of the head electrode 4 has an arc shape and is tangent to the arc surface of the conductive skeleton 21. When the head electrode 4 is connected with the energy generator and is used for transmitting ablation energy to target tissues, the head electrode 4 and the cambered surface at the far end of the conductive framework 21 are positioned on the same tangential plane, so that the head electrode 4 can be stably attached to focus tissues and can be ablated at any angle of the focus tissues, and the rapid, efficient and high-quality ablation effect is achieved.

When the head electrode 4 is used as an ablation electrode, it can be used as a pulse ablation function or a radio frequency ablation function. Medical staff can make a targeted ablation strategy according to different conditions of patients to adjust, so that the ablation range of the focus position is enlarged, and the ablation requirements of more indications are met.

For the ablation catheter 10 of the present embodiment, the ablation energy delivery to the target tissue region may be achieved by the cooperation of the conductive skeleton 21 and the plurality of electrodes 22, or by the cooperation of the conductive skeleton 21, the plurality of electrodes 22, and the head electrode 4.

Specifically, at least one of the plurality of electrodes 22 and the head electrode 4 is connected to a positive electrode of an energy generator, and the conductive skeleton 21 is connected to a negative electrode of the energy generator to form an electric field to deliver ablation energy to the target tissue region. Or at least one of the plurality of electrodes 22 and the head electrode 4 is connected to a negative electrode of the energy generator, and the conductive skeleton 21 is connected to a positive electrode of the energy generator to form an electric field to deliver ablation energy to the target tissue region. In addition, any one of the conductive skeleton 21, at least one of the plurality of electrodes 22, and the head electrode 4 may be selectively connected to one pole of an energy generator, and the other pole of the energy generator may be connected to an electrode plate attached to the patient's body surface to form an electric field to deliver ablation energy to the target tissue region. After ablation is finished, the electrodes 22 and the head electrodes 4 are used for potential mapping, compared with the method of mapping by only adopting the electrodes 22 on the bearing rods 211, the head electrodes 4 are additionally used as mapping electrodes, the number of the mapping electrodes is increased, the acquisition range and efficiency of electrophysiological signals can be greatly improved, further, mapping can be more accurate, and when the distal end part of the conductive framework 21 is attached to cardiac muscle, electrocardiographic signals in multiple directions can be acquired, so that the acquired potential signals are more accurate.

With continued reference to fig. 1, the ablation catheter 10 of the present embodiment further includes a plurality of reference electrodes 3 disposed on the wall of the distal end of the catheter body 1, where the reference electrodes 3 are disposed at intervals along the axial direction of the catheter body 1, and in this embodiment, the reference electrodes 3 are two ring electrodes, and it is understood that the shape and number of the reference electrodes 3 are not specifically limited, the reference electrodes 3 may be made of metal materials such as platinum, iridium, gold, silver, etc., and the connection manner with the catheter body 1 includes, but is not limited to, welding, clamping, bonding, integral forming, etc., and the length of the reference electrodes 3 is preferably 1.2mm. An opening is arranged at the connecting position of each reference electrode 3 and the pipe wall, a wire with an insulating layer is welded on the inner wall of each reference electrode 3, one end of the wire is welded on a connector on the handle, and the wire is connected to the inner wall of the reference electrode 3 through the opening by passing through the inner cavity of the catheter main body 1.

The first role of the reference electrode 3 on the wall of the catheter body 1 is to function as the reference electrode 3, i.e. for electrocardiographic mapping to obtain a reference potential. Specifically, the plurality of electrodes 22 on the conductive skeleton 21 can be well attached to the target tissue region to be used as a mapping electrode for mapping the electrocardiosignal of the target tissue region to obtain an electric potential, and the reference electrode 3 on the tube wall of the catheter main body 1 can also obtain a reference electric potential from the fluid in contact with the reference electrode 3 although not attached to the myocardial tissue, so that a relatively accurate electrocardiosignal can be obtained according to the difference between the reference electric potential obtained by the reference electrode 3 and the electric potential obtained by the electrode 22, thereby improving the accuracy of mapping. The second function of the reference electrode 3 on the wall of the catheter body 1 is to function as a positioning electrode of the three-dimensional mapping system, i.e. for displaying the tube body of the catheter body 1 during the three-dimensional modeling. The third function of the reference electrode 3 on the body of the catheter body 1 is to function as an ablation electrode, i.e. the reference electrode 3 can be used as a negative electrode for increasing the negative electrode discharge area and reducing the occurrence of electric sparks. For example, it will be appreciated that increasing the area of the anode may result in a decrease in impedance, but this is a normal phenomenon in which the baseline impedance reference needs to be reset.

In this embodiment, the conductive skeleton 21 is a unitary cage structure. The electrode 22 on the conductive skeleton 21 and the conductive skeleton 21 can be regarded as local punctiform ablation when discharging, and the requirements in operations such as tricuspid isthmus linear ablation, left atrium (Left atrium, LA) top line, left atrium (Right atrium, RA) bottom line, mitral isthmus line and the like in arrhythmia treatment can be met through point-by-point connection. The surgical procedure of the ablation catheter 10 of the present application is described below.

Referring now to fig. 4, the operation of the heart of a human subject is briefly described using the ablation catheter 10 of the present application. The delivery device 20 is delivered to the left atrium via the inferior vena cava (Inferior vena cava; IVC) and the right atrium by femoral vein puncture, the ablation catheter 10 is deployed in the left atrium by deflection of the delivery device 20, abnormal lesion areas are found by three-dimensional mapping, left atrial apex or mitral isthmus isolation is performed, and the abnormal activation points are cleared. At this time, the electrode 22 of the conductive skeleton 21 is abutted against the target tissue region (e.g., abnormal myocardial tissue), and when the electrode 21 is in contact with the target tissue region, a pulsed electric field is formed between the conductive skeleton 21 and the plurality of electrodes 22 on the conductive skeleton 21 to ablate the target tissue region, so that the tissue of the target tissue region is necrotized, and the rest of the electrodes 22 which are not in contact with the target tissue region are selectively turned off and not discharged. After completion, the delivery device 20 and ablation catheter 10 are withdrawn from the left atrium to the right atrium for isolation of the tricuspid isthmus, and the conductive framework 21 and the plurality of electrodes 22 on the conductive framework 21 are also used to form a pulsed ablation electric field for ablation.

In the process of performing pulse ablation by using the ablation catheter 10, a pulse electric field is formed between the positive electrode and the negative electrode to act on a target tissue region, the conductive framework 21 is used as the negative electrode, the conductive framework 21 is provided with the plurality of electrodes 22 as the positive electrode, the pulse electric field is formed between the plurality of electrodes 22 and the conductive framework 21 (or within a certain range around the conductive framework 21) to perform ablation, and the conductive framework 21 and the plurality of electrodes 22 on the conductive framework 21 are used as the positive electrode and the negative electrode to form a large-range electric field, and further, the conductive framework 21 can be radially expanded and then can be abutted against the tissue wall, so that the generated large-range electric field can cover the region within a certain range away from the tissue wall, thereby forming deeper ablation damage and improving the ablation effect of lesion tissues.

The ablation catheter 10 provided in this embodiment adopts a novel skeleton structure form and a bipolar ablation mode, and utilizes the conductive skeleton 21 and the plurality of electrodes 22 on the conductive skeleton 21 to perform positive and negative electrode ablation, so that the advantages of the bipolar ablation mode are fully utilized, that is, compared with the mode of a negative plate, the bipolar ablation mode has the advantages that current does not flow through skeletal muscles in the back and other areas, so that the bipolar ablation mode has smaller stimulation to the body, and the ablation depth is greatly improved while the bipolar ablation mode is utilized, the transmutation performance of ablation is ensured, and the ablation effect of the ablation catheter 10 is further improved.

Three-dimensional mapping is described herein. It will be appreciated that the electrodes 22 on the conductive skeleton 21 may be used as mapping electrodes for mapping cardiac electrical signals, in addition to being used as ablations. The electrodes 22 are connected by wires to connectors on the handle and then by cables to the energy generator in the pulse ablator 30, the three-dimensional mapping system 50, and the multi-conductor recorder 60, which are synchronized, and the signals connected to the energy generator can also be used by being connected to other systems via the output ports. The electrocardiographic signals connected to the three-dimensional mapping system 50 are processed by a computer to generate an activation map. Each mapping electrode is a single passage, when the electrocardiosignal passes through the mapping electrode, an electrocardiogram is generated and is called a monopolar electrocardiogram (marked as A), the other mapping electrode generates a monopolar electrocardiogram B, a bipolar electrocardiogram is actually used, and an electrocardiogram C is generated by using the A-B and is used for describing the distance between the electrocardiosignal and the two mapping electrodes. The closer to the mapping electrode, the larger the mapping signal, and the smaller the farther the signal. When the three-dimensional mapping system 50 is connected, the three-dimensional mapping system 50 and each mapping electrode form an electric loop, field intensity measurement is performed on each loop, mapping electrodes contacting the inner wall of the heart are positioned and traced through the distance relation between an electric field gradient equation and the reference electrode 3, the whole heart model can be constructed through movement of the ablation catheter 10, and meanwhile, cardiac electric signals are recorded when the mapping is performed, so that the heart model with exciting signals is formed.

Referring to fig. 2-5, fig. 5 is a schematic diagram illustrating the electric field distribution of the ablation catheter 10. The conductive skeleton 21 is a negative electrode, and the electrode 22 on the conductive skeleton 21 is a negative electrode, and the positive and negative electrodes of the ablation catheter 10 form a pulsed electric field as shown in fig. 5 to deliver ablation energy to the target tissue region. At an electric field strength of 500V/cm, the maximum coverage width of the pulsed electric field between the conductive skeleton 21 and the electrode 22 on the conductive skeleton 21 is about 5.3mm, and the ablation depth exceeds the mitral isthmus thickness (the mitral isthmus thickness can reach 4.0-5.2mm, and the mitral isthmus is the place where the atrial myocardial tissue is thickest), so that the ablation catheter 10 of the embodiment can form deeper ablation lesions, transmural ablation on lesion tissues, achieve a therapeutic effect, and reduce the recurrence rate of the operation.

In this embodiment, the ablation catheter 100 can also perform zone ablation on the target tissue region, thereby achieving precise zone ablation, and damage to the tissue not intended to be ablated can be avoided by zone local ablation. In addition, since the ablation energy can be targeted to the target tissue to be ablated, the utilization of the ablation energy is increased, the dissipation of the ablation energy in the blood is reduced, and unnecessary bubbles generated by electrolysis of the blood are reduced.

In some embodiments, when only a portion of the load bar 211 is in abutment with the target tissue region, the electrically conductive skeleton 21 and at least one electrode 22 on a portion of the load bar 211 may be selected to deliver ablation energy to the target tissue region, the at least one electrode 22 being of opposite polarity to the conductive skeleton 21.

Specifically, the conductive skeleton 21 is selected as the positive electrode, and the electrode 22 on the conductive skeleton 21 is selected as the negative electrode; of course, in other embodiments, the conductive skeleton 21 may be selected to be a negative electrode, and the electrode 22 on the conductive skeleton 21 may be selected to be a positive electrode. By detecting the impedance of each electrode 22, the contact condition is determined, and when only a part of the carrying bars 211 contact the target tissue region, at least one electrode 22 and the conductive skeleton 21 are selected from the part of the carrying bars 211 contact the target tissue region to participate in the partial discharge, and at least one electrode 22 may be one or more electrodes 22 selected from one carrying bar 211 or a plurality of electrodes 22 selected from a plurality of carrying bars 211, for example, a plurality of electrodes 22 and the conductive skeleton 21 on two adjacent carrying bars 211 are selected to participate in the partial discharge to transfer ablation energy to the target tissue region. Wherein the conductive skeleton 21 is of opposite polarity to the selected electrode 22. After ablation is completed, all electrodes 22 on the conductive skeleton 21 participate in mapping.

In other embodiments, when only a portion of the load bar 211 is in abutment with the target tissue region, the electrode 22 on the electrically conductive portion of the load bar 211, which is of opposite polarity, may be selected to deliver ablation energy to the target tissue region. The electrodes 22 with opposite polarities may be all located on the same carrier bar 211, and of course, the electrodes 22 with opposite polarities are located on a plurality of carrier bars 211 disposed at intervals, for example, the electrodes 22 on two adjacent carrier bars 211 have opposite polarities. After ablation is completed, all electrodes 22 on the conductive skeleton 21 participate in mapping.

Second embodiment

Referring to fig. 6 to 8, the ablation catheter 10 of the second embodiment is substantially identical in structure to the ablation catheter 10 of the first embodiment, and the ablation catheter 10 of the second embodiment is mainly different from the ablation catheter 10 of the first embodiment described above in that: the structure of the conductive skeleton 21 and the arrangement of the electrodes 22 on the conductive skeleton 21 in this embodiment are different, and in addition, the ablation catheter 10 of this embodiment further includes the head electrode 4. It should be noted that, the remaining structures of the ablation catheter 10 provided in the second embodiment are the same as those of the first embodiment, and will not be described herein.

In the present embodiment, the conductive frame 21 includes a first connection frame 212 and a second connection frame 213. In the fully expanded state of the conductive framework 21, the first connection frame 212 and the second connection frame 213 are each a frame structure having an inner cavity. The first connection frame 212 is disposed at a distal end with respect to the second connection frame 213, a proximal end of the first connection frame 212 is connected to a distal end of the second connection frame 213, and a proximal end of the second connection frame 213 is connected to a distal end of the catheter main body 1.

The axial length of the first connection frame 212 is equal to the axial length of the second connection frame 213. It is understood that in some embodiments, the axial length of the first connection frame 212 may also be less than or greater than the axial length of the second connection frame 213.

In this embodiment, the first connection frame 212 includes a plurality of connection bars 2121. A plurality of connecting bars 2121 are spaced around the central axis L of the conductive backbone 21. Distal ends of the plurality of connection bars 2121 are close to and fixed to each other toward the central axis L of the conductive skeleton 21. The proximal ends of the plurality of connection bars 2121 are connected to the distal ends of the second connection frame 213. Illustratively, the connecting rod 2121 may be generally rod-shaped, and in other examples, the connecting rod 2121 may also be an elongated plate-like structure.

In the present embodiment, the first connection frame 212 is a multi-bar frame structure, which has good flexibility, so the first connection frame 212 is easier to be abutted. Wherein the connecting rod 2121 may also be three, four, five, six, seven, eight, nine, or any other suitable number. Illustratively, the number of connecting rods 2121 in this embodiment is nine.

The second connection frame 213 comprises a plurality of struts 2131, the plurality of struts 2131 being connected end to end with each other to form a lattice structure 2132 having a plurality of lattices arranged circumferentially about the central axis L of the conductive skeleton 21, the proximal end of the lattice structure 21311 being connected to the distal end of the catheter body 1, the distal end of the lattice structure 21311 being connected to the proximal ends of the plurality of connection rods 2121.

The second connection frame 213 is formed with a plurality of grids, and is in a dense grid structure as a whole, so that the second connection frame 213 has better supporting performance, and can well support the first connection frame 212, so that the conductive framework 21 is kept in a sphere-like shape as a whole, and is convenient to form good adhesion with a target tissue region.

The grid structure 2132 formed by the second connection frame 213 comprises a plurality of grid sets 2133 and a plurality of connection grids 2134, the plurality of grid sets 2133 being circumferentially arranged around the central axis L of the conductive skeleton 21, each grid set 2133 comprising at least one primary grid 2135, two neighboring primary grids 2135 sharing one grid node, at least one connection grid 2134 being provided between two neighboring grid sets 2133, at least one connection grid 2134 multiplexing one side with at least two primary grids 2135 in two neighboring grid sets 2133, respectively, the primary grid 2135 and the connection grid 2134 being polygons, such as diamond, trapezium, pentagon, hexagon or other polygons.

Illustratively, in this embodiment, each grid set 2133 includes two primary grids 2135, a first primary grid 21351 and a second primary grid 21352, respectively. First main grid 21351 and second main grid 21352 share a grid node, two adjacent first main grids 21351 share a grid node, and two adjacent second main grids 21352 share a grid node. A first connecting grid 21341 and a second connecting grid 21342 are arranged between two adjacent grid groups 2133, one side of the first connecting grid 21341 is multiplexed with two first main grids 21351 and two second main grids 21352 in the two adjacent grid groups 2133 respectively, one side of the second connecting grid 21342 is multiplexed with two second main grids 21352 in the two adjacent grid groups 2133 respectively, and one side of the two adjacent second connecting grids 21342 is multiplexed, so that the occupied space of the second connecting frame 213 is smaller, the second connecting frame 213 is easier to scale, and the stability of the connection between every two adjacent grids through edges is stronger. The second connection mesh 21342 is an open polygon, and the proximal end of the second connection mesh 21342 is connected to the distal end of the catheter body 1. The proximal end of the second connection grid 21342 is connected to the distal end of the catheter body 1 by one or more combinations including, but not limited to, welding, clamping, adhesive, heat welding, threaded connection, sealing connection, and the like. The specific connection mode is selected according to the use requirement or the functional requirement. The second connection frame 213 in this embodiment includes nine first main grids 21351, nine second main grids 21352, nine first connection grids 21341 and nine second connection grids 21342, and the first main grids 21351, the second main grids 21352, the first connection grids 21341 and the second connection grids 21342 are diamond-shaped. It is to be understood that the shape and number of the mesh are not particularly limited in this embodiment, and the shape of the mesh may be other polygons, for example, pentagons, hexagons, and the like.

The conductive frame 21 of the present embodiment is provided with at least one electrode 22, and specifically, each connecting rod 2121 of the first connecting frame 212 and/or the second connecting frame 213 are provided with at least one electrode 22.

Illustratively, as in the first embodiment, the plurality of electrodes 22 still include a plurality of first electrodes 221, a plurality of second electrodes 222, and a plurality of third electrodes 223, unlike the first embodiment, the plurality of first electrodes 221 and the plurality of second electrodes 222 are disposed on the first connection frame 212, and the plurality of third electrodes 223 are disposed on the second connection frame 213. The plurality of connecting rods 2121 in the first connecting frame 212 includes a plurality of first connecting rods 21211 and a plurality of second connecting rods 21212, at least two second connecting rods 21212 are disposed between two adjacent first connecting rods 21211, a first electrode 221 and a second electrode 222 are disposed between each first connecting rod 21212 from a distal end to a proximal end in an axial direction, each second connecting rod 21212 is disposed with a second electrode 222, a plurality of third electrodes 223 are disposed at a grid node shared by two adjacent first grids 21351, a first ring 2211 is formed by the plurality of first electrodes 221 in a circumferential direction of the first connecting frame 212, a second ring 2221 is formed by the plurality of second electrodes 222 in a circumferential direction of the first connecting frame 212, a third ring 2231 is formed by the plurality of third electrodes 223 in a circumferential direction of the second connecting frame 213, planes of the first ring 2211 and the second ring 2221 are parallel to each other, and the planes of the planes are all perpendicular to the central axis L of the conductive frame 21.

The arrangement and the number of the electrodes 22 are merely illustrative, and are not particularly limited. In other embodiments, it is also possible to provide at least one electrode 22 only on the connection rod 2121 of the first connection frame 212.

The conductive framework 21 of this embodiment adopts two part designs, and the proximal end portion adopts the second connection frame 213 of close net design, and the distal end portion adopts the first connection frame 212 of many pole structural design, and close net structural support performance is good, and many pole structural compliance is better, and is more easily to lean on, so, the conductive framework 21 of this embodiment can possess good supporting property and compliance simultaneously, and supporting property is favorable to conductive framework 21 to keep cage-like structure, realizes arbitrary angle location on the target tissue region, and compliance can be favorable to conductive framework 21 to fully lean on with the target tissue region and realize the ablation, avoids causing the ablation effect to be poor because lean on.

Third embodiment

Referring to fig. 9 to 10, the ablation catheter 10 of the third embodiment is substantially identical in structure to the ablation catheter 10 of the second embodiment, the conductive framework 21 of the present embodiment also includes a first connection frame 212 and a second connection frame 213, the first connection frame 212 includes a plurality of connection bars 2121, the second connection frame 213 includes a plurality of struts 2131, the plurality of struts 2131 are connected end to end with each other to form a lattice structure 2132 having a plurality of lattices, the lattice structure 2132 also includes a plurality of lattice groups 2133 and a plurality of connection lattices 2134, except that the ablation catheter 10 does not include a head electrode 4, the specific structure of the lattice structure 2132 is different, the connection bars 2121 are further provided with at least one recess 21211 along the axial direction thereof, and the arrangement manner of the electrodes 22 is also different.

Specifically, grid structure 2132 of the present embodiment includes a plurality of grid sets 2133 and a plurality of connection grids 2134, the plurality of grid sets 2133 are circumferentially arranged around central axis L of conductive skeleton 21, each grid set 2133 includes at least one main grid 2135, two adjacent main grids 2135 multiplex one side, at least one connection grid 2134 is provided between two adjacent grid sets 2133, at least one connection grid 2134 multiplexes one side with at least two main grids 2135 in two adjacent grid sets 2133, respectively, and main grid 2135 and connection grid 2134 are each polygonal, for example, diamond, trapezoid, pentagon, hexagon or other polygon.

Illustratively, in the present embodiment, each grid set 2133 includes one main grid 2135, two adjacent main grids 2135 are multiplexed on one side, one connecting grid 2134 is further provided between two adjacent main grids 2135, one connecting grid 2134 is multiplexed on one side with two adjacent main grids 2135, two adjacent connecting grids 2134 are multiplexed on one side, connecting grid 2134 is an open polygon, and the proximal end of connecting grid 2134 is connected with the distal end of catheter body 1. The manner of connecting the proximal end of grid 2134 to the distal end of catheter body 1 includes, but is not limited to, one or more of welding, clamping, adhesive, heat sealing, threading, sealing, and the like. The specific connection mode is selected according to the use requirement or the functional requirement. The second connection frame 213 in this embodiment includes six main grids 2135 and six connection grids 2134, and the main grids 2135 are hexagons and the connection grids 2134 are open diamond shapes. It will be appreciated that the shape and number of the mesh are not particularly limited in this embodiment, and the shape of the mesh may be other polygons, such as a diamond, a pentagon, or the like.

In this embodiment, the connecting rod 2121 is further provided with at least one recess 21213 along the axial direction thereof, the electrode 22 provided on the conductive framework 21 is installed in the recess 21213, and the axial length of the electrode 22 is slightly greater than the recess depth of the recess 21213, on one hand, the recess 21213 is formed on the connecting rod 2121, and the electrode 22 is embedded in the recess 21213, so that the protrusion of the surface of the whole cage-shaped sphere can be effectively reduced, the outer surface of the first connecting frame 212 of the conductive framework 21 is relatively smooth, and the resistance of the ablation catheter 10 entering into the patient tissue is reduced; on the other hand, the electrode 22 is slightly higher than the notch, so that an acting point for abutting against myocardial tissue can be formed, and the conductive framework 21 can better abut against continuously beating cardiac muscle, so that the ablation effect and the ablation stability are improved.

Further, the connecting rod 2121 may be provided with a plurality of concave portions 21213 along an axial direction thereof, in the plurality of connecting rods 2121, the concave portions 21213 are in one-to-one correspondence along the axial direction of the catheter main body 1 and are circumferentially spaced around the central axis L of the conductive framework 21, each concave portion 21213 is internally provided with one electrode 22 correspondingly, the plurality of electrodes 22 form a plurality of rings in the circumferential direction of the first connecting frame 212, and a plane in which each ring is located is perpendicular to the central axis L of the conductive framework 21.

Referring to fig. 10, fig. 10 shows a schematic view of a recess portion of the ablation catheter of fig. 9, the recess portion 21213 may include two bending sections 212131 and a central section 212132, the central section 212132 is connected between the two bending sections 212131, a central hole (not shown in the drawing) is formed in the central section 212132, the electrode 22 may be made of medical metals such as platinum, iridium, gold and silver for interventional therapy, and is in a cylindrical shape, one end surface of the cylindrical body near the connecting rod 2121 is provided with a protrusion (not shown in the drawing), the end surface is attached to a surface of the central section 212132, which is not facing the inner space of the conductive framework 21, and the protrusion is inserted into the central hole in the central section 212132 to be in interference fit, so that the electrode 22 is fixedly connected to the recess portion 21213, and the other end surface of the electrode 22 is slightly higher than the recess of the recess portion 21213. In this embodiment, the protrusion on the electrode 22 is matched with the central hole, so that the firmness of fixing the electrode 22 on the recess 21211 can be improved, and the electrode 22 is prevented from falling off.

It should be noted that, in addition to the above-described exemplary fastening manner, the manner in which the electrode 22 is mounted in the recess 21213 may be one or a combination of several of welding, bonding, screwing, etc., and the specific connection manner is selected according to the use requirement or the functional requirement.

The foregoing has outlined rather broadly the more detailed description of embodiments of the application, wherein the principles and embodiments of the application are explained in detail using specific examples, the above examples being provided solely to facilitate the understanding of the method and core concepts of the application; meanwhile, as those skilled in the art will appreciate, modifications will be made in the specific embodiments and application scope in accordance with the idea of the present application, and the present disclosure should not be construed as limiting the present application.

Claims

1. An ablation catheter, comprising:

A catheter body;

2. The ablation catheter of claim 1, wherein the conductive backbone comprises a plurality of carrier bars spaced around a central axis of the conductive backbone, wherein proximal ends of the plurality of carrier bars are connected to distal ends of the outer tube, and wherein distal ends of the plurality of carrier bars are tapered toward the central axis of the conductive backbone and are secured to one another.

3. The ablation catheter of claim 2, wherein each of the carrier rods has at least one of the electrodes, and a plurality of the electrodes are formed with at least one ring shape in a circumferential direction of the conductive skeleton, the ring shape lying in a plane perpendicular to a central axis of the conductive skeleton.

4. The ablation catheter of claim 3, wherein the carrier rod has an outermost end radially furthest from a central axis of the support skeleton, the electrode being disposed between a distal end of the carrier rod and the outermost end.

5. The ablation catheter of claim 3, wherein the plurality of carrier bars comprises a plurality of first carrier bars and a plurality of second carrier bars, at least two of the second carrier bars being disposed between adjacent two of the first carrier bars, the first carrier bars and the second carrier bars being provided with different numbers of the electrodes, respectively.

6. The ablation catheter of claim 5, wherein the plurality of electrodes comprises a plurality of first electrodes, a plurality of second electrodes, and a plurality of third electrodes, the first electrode, the second electrode, and the third electrode are disposed on the first carrier rod along the axial direction from the distal end to the proximal end thereof, the second electrode and the third electrode are disposed on the second carrier rod along the axial direction from the distal end to the proximal end thereof, the plurality of first electrodes form a first ring shape in the circumferential direction of the conductive skeleton, the plurality of second electrodes form a second ring shape in the circumferential direction of the conductive skeleton, and the plurality of third electrodes form a third ring shape in the circumferential direction of the conductive skeleton, and the first ring shape, the second ring shape, and the third ring shape lie in planes that are all perpendicular to the central axis of the conductive skeleton.

7. The ablation catheter of claim 1, wherein the conductive framework comprises a first connection frame and a second connection frame, the first connection frame disposed distally relative to the second connection frame, a proximal end of the first connection frame connected to a distal end of the second connection frame, and a proximal end of the second connection frame connected to a distal end of the catheter body.

8. The ablation catheter of claim 7, wherein the first connection frame comprises a plurality of connection bars, the plurality of connection bars being spaced around the central axis of the conductive framework, the distal ends of the plurality of connection bars being proximate to and secured to the central axis of the conductive framework, the proximal ends of the plurality of connection bars being connected to the distal ends of the second connection frame.

9. The ablation catheter of claim 8, wherein the second connection frame comprises a plurality of struts connected end-to-end to each other to form a lattice structure, a proximal end of the lattice structure being connected to a distal end of the catheter body, a distal end of the lattice structure being connected to proximal ends of the plurality of connection rods.

10. The ablation catheter of claim 9, wherein the lattice structure comprises a plurality of lattice sets and a plurality of connecting lattices, the plurality of lattice sets being circumferentially arranged about a central axis of the conductive framework, at least one of the connecting lattices being disposed between adjacent two of the lattice sets, each of the lattice sets comprising at least one primary lattice, at least one of the connecting lattices being multiplexed with at least two of the primary lattices in adjacent two of the lattice sets, respectively, the primary and connecting lattices each having a polygonal profile.

11. The ablation catheter of claim 10, wherein each of the grid sets comprises two primary grids, a first primary grid and a second primary grid, respectively, the first primary grid and the second primary grid sharing a grid node, two adjacent primary grids sharing a grid node; a first connecting grid and a second connecting grid are arranged between two adjacent grid groups, the first connecting grid and two first main grids and two second main grids in two adjacent grid groups are respectively multiplexed on one side, the first connecting grid and two second main grids in two adjacent grid groups are respectively multiplexed on one side, two adjacent second connecting grids are multiplexed on one side, the second connecting grid is an open polygon, and the proximal end of the second connecting grid is connected to the distal end of the catheter main body.

12. The ablation catheter of claim 10, wherein each of the grid sets comprises one of the primary grids, adjacent two of the primary grids multiplexing one side; one connecting grid is arranged between two adjacent grid groups, one side of each connecting grid is multiplexed with two main grids in two adjacent grid groups, one side of each adjacent two connected grids is multiplexed, each connecting grid is an open polygon, and the proximal end of each connecting grid is connected with the distal end of the catheter main body.

13. The ablation catheter of claim 11, wherein at least one electrode is disposed on each of the connecting rods, the plurality of connecting rods including a plurality of first connecting rods and a plurality of second connecting rods, at least two of the second connecting rods being disposed between adjacent two of the first connecting rods; the electrodes comprise a plurality of first electrodes and a plurality of second electrodes, the first electrodes and the second electrodes are arranged on the first connecting rod from the far end to the near end along the axial direction of the first connecting rod, the second electrodes are arranged on the second connecting rod, the first electrodes are formed with a first ring shape in the circumferential direction of the first connecting frame, the second electrodes are formed with a second ring shape in the circumferential direction of the first connecting frame, and the planes of the first ring shape and the second ring shape are perpendicular to the central axis of the conductive framework.

14. The ablation catheter of claim 13, wherein the plurality of electrodes further comprises a plurality of third electrodes disposed at positions of grid nodes shared by two adjacent first main grids, the plurality of third electrodes forming a third ring shape in a circumferential direction of the second connection frame, and a plane of the third ring shape being perpendicular to a central axis of the conductive skeleton.

15. The ablation catheter of claim 12, wherein the connecting rod is provided with at least one recess along an axial direction thereof, the electrode being mounted in the recess, an axial length of the electrode being greater than a recess depth of the recess.

16. The ablation catheter of claim 15, wherein the recess comprises two bending sections and a central section, the central section is connected between the two bending sections, a central hole is formed in the central section, a protrusion is formed on one surface of the electrode, which is close to the connecting rod, and the protrusion is matched with the central hole, so that the electrode is fixedly connected in the recess.

17. The ablation catheter of claim 16, wherein a plurality of concave portions are provided, in the plurality of connecting rods, the concave portions are in one-to-one correspondence along the axial direction of the catheter main body and are circumferentially arranged at intervals around the central axis of the conductive framework, one electrode is correspondingly arranged in each concave portion, a plurality of annular electrodes are formed in the circumferential direction of the first connecting frame, and the plane of each annular electrode is perpendicular to the central axis of the conductive framework.

18. The ablation catheter of any of claims 13-17, wherein at least one of the electrodes on the electrically conductive backbone and on a portion of the connecting rod is selected to be electrically conductive when only a portion of the connecting rod is in abutment with the target tissue region to deliver the ablation energy to the target tissue region, the polarity of at least one of the electrodes and the electrically conductive backbone.

19. The ablation catheter of any of claims 13-17, wherein at least two of the electrodes of opposite polarity on the electrically conductive portion of the connecting rod are selected to deliver the ablation energy to the target tissue region when only a portion of the connecting rod is in abutment with the target tissue region.

20. The ablation catheter of any of claims 1-17, wherein the ablation assembly further comprises a tip electrode disposed at a distal-most end of the conductive skeleton, the tip electrode and the conductive skeleton being insulated from each other, the tip electrode being for potential mapping and/or for cooperating with at least one of the electrode and the conductive skeleton to deliver the ablation energy to the target tissue region.

21. The ablation catheter of any of claims 1-17, further comprising at least one of the reference electrodes secured to a distal end of the catheter body, the reference electrode for potential mapping to obtain a reference potential.

22. An ablation system comprising a pulsed ablation device and the ablation catheter of any of claims 1-21, the ablation catheter being connected to the pulsed ablation device.