CN118044877A

CN118044877A - Ablation catheter and ablation system

Info

Publication number: CN118044877A
Application number: CN202211408041.5A
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: 2024-05-17

Abstract

The embodiment of the application discloses an ablation catheter and an ablation system. The inner tube is coaxially and movably arranged in the outer tube in a penetrating way. The first ablation assembly is disposed at the distal end of the inner tube for punctiform ablation of a target tissue region. The second ablation assembly is arranged at the proximal end of the first ablation assembly, the proximal end of the second ablation assembly is connected with the distal end of the outer tube, and the second ablation assembly is used for performing annular ablation on a target tissue region. The ablation catheter and the ablation system integrate point-shaped ablation and annular ablation functions, can be used for continuous atrial fibrillation ablation treatment, meets the ablation requirement of any position of the heart, and has higher ablation efficiency.

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

The occurrence of persistent atrial fibrillation has so far remained a very complex procedure, the main mechanism of which can be divided into a trigger mechanism and a maintenance mechanism. Trigger mechanisms include ganglion plexus, marshall (Marsha l l) ligament, coronary sinus intramuscularly cuff, non-pulmonary venous trigger, pulmonary venous intramuscularly cuff, and the like. The maintenance mechanism includes a fragmentation potential zone, cardiac muscle fibrosis, a low potential zone at sinus rate, etc. Different treatment strategies are available for the trigger and maintenance mechanisms, respectively.

For a patient with continuous atrial fibrillation of a multi-trigger mechanism, after pulmonary vein isolation, the operation of dotting and scribing is needed to be carried out on the areas such as the top of the left atrium, the mitral valve, the tricuspid valve and the like, however, in the existing operation process, dotting and scribing ablation and pulmonary vein isolation are completed through different ablation catheters, so that the overall time required for completing the operation is long, and the ablation efficiency is low. There is a need for a medical device that combines pulmonary vein isolation with score isolation.

Disclosure of Invention

The application aims to provide an ablation catheter and an ablation system, which integrate point-shaped ablation and annular ablation functions, can be used for continuous atrial fibrillation ablation treatment, meet the ablation requirement of any position of a heart, and have higher ablation efficiency.

In a first aspect the present application provides an ablation catheter comprising an outer tube, an inner tube, a first ablation assembly, and a second ablation assembly. The inner tube is coaxially and movably arranged in the outer tube in a penetrating way. The first ablation assembly is disposed at the distal end of the inner tube for punctiform ablation of a target tissue region. The second ablation assembly is arranged at the proximal end of the first ablation assembly, the proximal end of the second ablation assembly is connected with the distal end of the outer tube, and the second ablation assembly is used for performing annular ablation on a target tissue region.

In a second aspect, the present application provides an ablation system comprising a pulsed ablation device and an ablation catheter of any of the preceding claims, the ablation catheter being connected to the pulsed ablation device.

The embodiment of the application provides an ablation catheter and an ablation system, wherein the ablation catheter is provided with a first ablation assembly and a second ablation assembly, the first ablation assembly can perform punctiform ablation on a target tissue area, the second ablation assembly can perform annular ablation on the target tissue area, the punctiform ablation function and the annular ablation function are integrated, the punctiform ablation can be realized by using the ablation catheter in the operation process, the annular ablation can be realized, the ablation catheter can be used for continuous atrial fibrillation ablation treatment, the ablation requirement of any position of a heart is met, and the ablation efficiency is improved.

Drawings

FIG. 1 is a schematic diagram of a pulse ablation system according to the present application;

FIG. 2 is a schematic view of a portion of the ablation catheter of FIG. 1 in a use configuration;

FIG. 3 is a schematic cross-sectional view of the ablation catheter of FIG. 2 taken along line A-A;

FIG. 4 is a schematic illustration of the structure of the second ablation assembly of FIG. 2;

FIG. 5 is a schematic illustration of the configuration of the first ablation assembly of FIG. 2;

FIG. 6 is a schematic cross-sectional view of the first ablation assembly of FIG. 5 taken along line B-B;

FIG. 7 is a schematic view of the ablation catheter of FIG. 2 at another angle;

FIG. 8 is a schematic view of the structure of the ablation catheter of FIG. 1 in two different use scenarios;

FIG. 9 is a schematic view of a portion of the ablation catheter of FIG. 1 in another use scenario;

FIG. 10 is a schematic view of an ablation catheter according to the present application in various use conditions in some embodiments;

FIG. 11 is a schematic view of a portion of an ablation catheter in accordance with another embodiment of the application;

FIG. 12 is a schematic cross-sectional view of the ablation catheter of FIG. 11 taken along line C-C;

FIG. 13 is a schematic view of a portion of the structure of an ablation catheter provided in accordance with the present application in still other embodiments;

Fig. 14 is a schematic view of the ablation catheter of fig. 13 at another angle.

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 description of the present application, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present application will be understood in specific cases by those of ordinary skill in the art. The term "and/or" is an association relationship describing an associated object, meaning that there may be three relationships, e.g., a and/or B, which may represent: a exists alone, A and B exist together, and B exists alone.

In the description of the present specification, reference to an embodiment of the terms "embodiment," "specific embodiment," "example," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the application. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.

For ease of description, in the field of endoluminal interventions, the proximal end refers to the end of the instrument that is close to the operator after the intervention, and the distal end refers to the end of the instrument that is far from the operator after the intervention. "proximal" and "distal" are non-limiting directional descriptions.

According to the ablation catheter and the ablation system, the first ablation assembly can conduct punctiform ablation on the target tissue area, the second ablation assembly can conduct annular ablation on the target tissue area, the punctiform ablation function and the annular ablation function are integrated, so that punctiform ablation can be achieved by using the ablation catheter in the operation process, annular ablation can be achieved, the ablation catheter can be used for continuous atrial fibrillation ablation treatment, the ablation requirement of any position of a heart is met, and the ablation efficiency is improved.

In particular use, the ablation catheter of the present application may be percutaneously delivered via an ablation sheath to a specific location of the heart, such as the mitral isthmus, tricuspid isthmus, left atrial apex, pulmonary veins, left atrial appendage, or a triggering device incorporating typical atrial flutter, non-pulmonary venous origin (e.g., superior vena cava, coronary sinus ostium), for ablation.

It should be noted that, the target tissue area of the first ablation assembly for punctiform ablation and the target tissue area of the second ablation assembly for annular ablation may be the same or different, for example, the target tissue area of the first ablation assembly for punctiform ablation is the top of the left atrium, and the target tissue area of the second ablation assembly for annular ablation is the pulmonary vein; for another example, the target tissue region where the first ablation assembly performs punctiform ablation and the target tissue region where the second ablation assembly performs annular ablation are both pulmonary veins, and if a local abnormal potential still exists after the annular ablation is performed on the pulmonary veins by the second ablation assembly, the punctiform ablation can be performed on the pulmonary veins by the first ablation assembly.

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

In some embodiments, the pulsed ablation system 100 includes an ablation catheter 10, a pulsed ablator 30, a patch panel 40, a three-dimensional mapping system 50, and a multi-guide recorder 60. The ablation catheter 10 is connected to the pulse ablator 30 by an ablation line 20a and a mapping line 20 b. The mapping lines 20b of the ablation catheter 10 are also connected to a patch panel 40, a three-dimensional mapping system 50 and a multi-guide recorder 60, respectively. The ablation catheter 10 may be used for dotting ablation of the mitral isthmus, tricuspid isthmus, left atrial apex line, left atrial posterior wall line, fragmentation potential zone, large annulus around pulmonary veins, etc., as well as for annular ablation of pulmonary vein ostia, etc.

In some embodiments, the pulse ablator 30 includes a user interface, a pulse generator, a controller, and a data storage module. The user interface is used for indicating various operations of the pulse ablation instrument 30, the to-be-ablated region and other information, so that the user can conveniently use the pulse ablation instrument. The pulse 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, the operator can operate the pulse ablator 30 to control the ablation catheter 10 to reach the low voltage region or focus of the heart of the patient for precise ablation, thereby blocking the transmission of abnormal electrical signals.

In some embodiments, the three-dimensional mapping system 50 employs electric field modeling in combination with electrocardiographic mapping. 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-conductivity recorder 60 is used for recording electrocardiographic signals.

In this embodiment, the heart model formed by the body surface leads and the ablation catheter 10 contains a lot of noise, and the three-dimensional mapping system 50 can also correct the coordinate values of the image in the three-dimensional model by inputting the image data of the computed tomography and the image data of the subtraction angiography and then combining the algorithm so as to construct a finer three-dimensional image, thereby being convenient for an operator to more accurately control the ablation catheter 10 to perform discharge ablation.

Referring to fig. 2 and 3 in combination, fig. 2 is a schematic view of a portion of the ablation catheter 10 shown in fig. 1 in a use state, and fig. 3 is a schematic view of a cross-sectional structure of the ablation catheter 10 shown in fig. 2 taken along A-A.

In some embodiments, the ablation catheter 10 may include an outer tube 1, an inner tube 2, a first ablation assembly 101, a second ablation assembly 102, and an irrigation catheter 7. The outer tube 1 and the inner tube 2 are hollow structures, the inner tube 2 is coaxially and movably arranged in the outer tube 1 in a penetrating manner, the infusion catheter 7 is positioned on the inner side of the inner tube 2, and the distal end of the infusion catheter 7 is positioned on the inner side of the first ablation assembly 101. A first ablation assembly 101 is provided at the distal end of the inner tube 2. The first ablation assembly 101 may be used as a spot ablation structure for the ablation catheter 10 for spot ablating a target tissue region. The second ablation assembly 102 is provided at the proximal end of the first ablation assembly 101, the proximal end of the second ablation assembly 102 being connected to the distal end of the outer tube 1. The second ablation assembly 102 may be configured as an annular ablation structure of the ablation catheter 10 for annular ablation of a target tissue region.

In some embodiments, the first ablation assembly 101 includes a conductive backbone 3 with a proximal end of the conductive backbone 3 mounted to a distal end of the inner tube 2 and a plurality of second electrodes 6 secured to the conductive backbone 3. The conductive skeleton 3 may be made of a conductive material. The conductive framework 3 is a multi-surface grid structure. The second ablation assembly 102 includes a plurality of secondary rods 4 and a plurality of first electrodes 5, the distal end of each secondary rod 4 being secured to the distal end of the inner tube 2, the proximal end of each secondary rod 4 being secured to the distal end of the outer tube 1. Each auxiliary rod 4 has an arc-shaped structure. In other embodiments, each secondary rod 4 may also be of helical or other curvilinear type. The first electrodes 5 are provided on the sub-rod 4, and the plurality of first electrodes 5 can form an annular electric field to perform annular ablation on the target tissue region.

In the present embodiment, the first ablation assembly 101 of the ablation catheter 10 is used for spot ablation of a target tissue region and the second ablation assembly 102 is used for ring ablation of the target tissue region. Compared with the existing ablation catheter, the ablation catheter 10 provided by the application integrates the spot-shaped ablation function and the annular ablation function, so that spot ablation and annular ablation can be realized by using the ablation catheter 10 in the operation process, the ablation catheter can be used for continuous atrial fibrillation ablation treatment, the ablation requirement of any position of the heart is met, and the ablation efficiency is improved.

In some embodiments, a plurality of secondary rods 4 are disposed around the inner tube 2, with the plurality of secondary rods 4 being spaced apart from one another. The plurality of auxiliary rods 4 are symmetrically arranged around the axial direction of the inner tube 2. Wherein the number of secondary bars 4 may be three, four, five, six, eight or other suitable number. Illustratively, the number of secondary rods 4 is six, and the six secondary rods 4 may be equally spaced so as to achieve omnidirectional ablation of the target tissue. In other embodiments, the plurality of auxiliary rods 4 may be asymmetrically arranged, and the plurality of auxiliary rods 4 may be spaced around only the axial direction of the inner tube 2, which is not strictly limited by the present application.

In some embodiments, the infusion catheter 7 may include a plurality of irrigation ports 71, a plurality of spiral channels 72, and a guidewire channel 73, the irrigation ports 71 being connected to the spiral channels 72 and exposed opposite the distal end 74 of the infusion catheter 7, the spiral channels 72 being located inside the infusion catheter 7. The irrigation port 71 of the irrigation catheter 7 is located inside the conductive skeleton 3. Located inside the spiral channel 72 is a guide wire channel 73, which guide wire channel 73 may be used for feeding a guide wire or for installing a traction wire (not shown in the figures). In other embodiments, the ablation catheter 10 may be provided without the irrigation catheter 7, which is not strictly limited by the present application.

In this embodiment, the irrigation catheter 7 is connected to a pulse ablator 30 for irrigating an irrigation liquid, which may be saline, for example, into the conductive skeleton 3 during ablation therapy. The channel of the perfusion catheter 7 is spiral, and the cross-sectional flow rate of the flushing liquid at the flushing port 71 can be increased by spiral, so that the flushing liquid is dispersed towards multiple directions inside the conductive framework 3 to fully flush the conductive framework 3, thereby reducing blood stasis, avoiding thrombosis and preventing cumulative thermal effect after repeated pulse ablation.

Referring to fig. 2 and 4 in combination, fig. 4 is a schematic diagram of the second ablation assembly 102 of fig. 2.

In some embodiments, the plurality of first electrodes 5 are fixed to the plurality of sub-rods 4 in one-to-one correspondence. The secondary rod 4 may include a carrier section 41 and a middle section 42, the carrier section 41 of the secondary rod 4 being disposed adjacent to the distal end of the secondary rod 4, and the first electrode 5 may be disposed on the carrier section 41 of the secondary rod 4. The first electrode 5 is arranged around the circumferential side of the carrier section 41 of the secondary rod 4. It should be noted that fig. 4 only illustrates the position of the carrier section 41 of one of the auxiliary bars 4 and the middle section 42 of the auxiliary bar 4. In the present embodiment, the curvature of the bending of the carrier section 41 of the auxiliary lever 4 is small during the bending of the auxiliary lever 4. When the first electrode 5 is fixed on the bearing section 41 of the auxiliary rod 4, the deformation of the first electrode 5 caused by the auxiliary rod 4 in the bending process can be avoided, so that the stability of the first electrode 5 is ensured.

In other embodiments, the first electrode 5 may be fixed to the middle portion 42 of the auxiliary rod 4, or fixed between the bearing section 41 of the auxiliary rod 4 and the middle portion 42 of the auxiliary rod 4, which is not strictly limited in the present application.

In some embodiments, the ablation catheter 10 may further include a first connector 43 and a second connector 44, the first connector 43 fixedly connecting the distal ends of the plurality of secondary shafts 4 and fixedly connecting the distal ends of the inner tube 2. The second connector 44 is fixedly connected to the proximal ends of the plurality of auxiliary rods 4 and fixedly connected to the distal end of the outer tube 1. The plurality of auxiliary rods 4, the first connecting piece 43 and the second connecting piece 44 may be integrally formed.

In this embodiment, the plurality of auxiliary rods 4 are fixed by the first connecting piece 43 and the second connecting piece 44 and are connected with the inner tube 2 and the outer tube 1, so that the fixation between the plurality of auxiliary rods 4 and the inner tube 2 and the outer tube 1 is more stable, and the plurality of auxiliary rods 4 are not easy to separate from the inner tube 2 and the outer tube 1 in the bending process.

In some embodiments, the plurality of first electrodes 5 of the ablation catheter 10 may be divided into a plurality of first electrode sets 51. The plurality of first electrode groups 51 are fixed to the plurality of sub-rods 4, respectively, that is, the plurality of first electrodes 5 fixed to the same sub-rod 4 form one first electrode group 51, and each sub-rod 4 is provided with one first electrode group 51. Each first electrode group 51 includes at least two first electrodes 5 arranged at intervals. Illustratively, each first electrode group 51 may include three first electrodes 5, i.e., three first electrodes 5 are fixed to each sub-rod 4. The first electrode 5 may be a ring electrode, a sheet electrode, or a rod electrode, which is not strictly limited in the present application.

In some embodiments, the first electrodes 5 may be used for ablation, the polarity of the first electrodes 5 on the same secondary rod 4 being the same, i.e. all the first electrodes 5 of the same first electrode set 51 being the same. In adjacent secondary rods 4, the first electrodes 5 are arranged in a one-to-one correspondence along the axial direction of the second ablation assembly 102 and the polarities of the corresponding first electrodes 5 are opposite, i.e. the first electrodes 5 on a secondary rod 4 are opposite to the polarities of the corresponding first electrodes 5 on an adjacent other secondary rod 4. The plurality of first electrodes 5 enclose at least one ring shape in the circumferential direction of the second ablation assembly 102, and the plurality of first electrodes 5 in each ring shape form an annular electric field for annular ablation of the target tissue region.

For example, each of the first electrode groups 51 may include three first electrodes 5 disposed at intervals, and the three first electrodes 5 may be denoted by a first electrode 511, a first electrode 512, and a first electrode 513, respectively, according to their positions on the sub-rod 4, and the first electrodes 511, 512, and 513 may be disposed at intervals. Illustratively, the first electrode 511 may be fixed to the distal end of the carrier section 41 of the secondary rod 4, the first electrode 513 may be fixed to the proximal end of the carrier section 41 of the secondary rod 4, and the first electrode 512 may be fixed between the first electrode 511 and the first electrode 513. In the adjacent sub-rod 4, the first electrodes 511, 512, and 513 in the two first electrode groups 51 are arranged in one-to-one correspondence in the axial direction of the second ablation assembly 102.

The polarities of the first electrode 511, the first electrode 512 and the first electrode 513 of the same first electrode group 51 are the same. The polarities of the first electrodes 511, 512, and 513 in one first electrode group 51 are opposite to the polarities of the first electrodes 511, 512, and 513 in the adjacent other first electrode group 51. That is, the first electrodes 5 of adjacent first electrode sets 51 in the second ablation assembly 102 may be paired with one another to form an electric field to annularly ablate a target tissue region.

Wherein, in the circumferential direction of the second ablation assembly 102, all the first electrodes 511 may enclose a ring shape, and a plurality of first electrodes 511 form an annular electric field in each ring shape. All of the first electrodes 512 may be formed in a ring shape, and a plurality of the first electrodes 512 in each ring shape form an electric field in a ring shape. All the first electrodes 513 may be enclosed in a ring shape, and a plurality of the first electrodes 513 in each ring shape form an electric field in a ring shape.

In this embodiment, the three first electrodes 5 of each first electrode group 51 can be used as ablation electrodes, and the three first electrodes 5 of the same first electrode group 51 have the same polarity and can perform discharge ablation simultaneously. Illustratively, the plurality of first electrodes 5 of the ablation catheter 10 may be divided into six regions, one region corresponding to each first electrode set 51, each first electrode set 51 being individually dischargeable. That is, the discharge may be performed with a part of the first electrode group 51, and another part of the first electrode group 51 does not participate in the discharge. The second ablation assembly 102 of the ablation catheter 10 may form six discharge regions altogether. When only a part of the first electrode group 51 participates in the discharge, the discharge area at the time of the discharge is reduced, and thus deeper ablation lesions can be formed. In addition, all of the first electrodes 5 of the ablation catheter 10 may also be discharged simultaneously to form an annular lesion, thereby enabling rapid ablation of the mitral isthmus, tricuspid isthmus, left atrial apex line, left atrial posterior wall line, fragmentation potential zone, large annulus surrounding the pulmonary vein, etc.

In some embodiments, the first electrode 5 is made of a conductive material, and illustratively, the material of the first electrode 5 may be platinum iridium alloy. The ablation catheter 10 further comprises a plurality of wires (not shown), one wire being connected to each of the first electrodes 5 individually. The first electrode 5 is electrically connected to the energy generator of the pulse ablator 30 by a wire. The auxiliary rod 4 has a hollow structure, and wires connected to the first electrode 5 are all accommodated inside the auxiliary rod 4. Wherein, the auxiliary rod 4 is made of insulating material on at least the outer surface, and the first electrode 5 is insulated from the auxiliary rod 4.

Referring to fig. 2, 5 and 6 in combination, fig. 5 is a schematic structural view of the first ablation assembly 101 shown in fig. 2, and fig. 6 is a schematic sectional structural view of the first ablation assembly 101 shown in fig. 5 taken along line B-B.

In some embodiments, the conductive skeleton 3 may be formed by three-dimensionally cutting a semi-regular polyhedral lattice to form a lattice structure, such as may be formed by laser cutting. Illustratively, the conductive skeleton 3 may be a continuous, integrally formed structure. In other embodiments, the conductive framework 3 of the ablation catheter 10 may include a plurality of plates 31, with the plurality of plates 31 being connected to one another to form a grid structure of the conductive framework 3, as the application is not limited in this regard.

In some embodiments, the conductive framework 3 may include a central grid 32 and a plurality of edge grid sets 33. Illustratively, the number of edge cell groups 33 is five. Each side grid set 33 includes at least one side grid, for example, each side grid set 33 may include a first side grid 331 and a second side grid 332. Two adjacent first side grids 331 and a central grid 32 form a first grid structure 34, and the center of the first grid structure 34 forms a first grid node 341. The first edge mesh 331 of the edge mesh group 33, the second edge mesh 332, and the first edge mesh 331 of the adjacent edge mesh group 33 form a second mesh structure 35, and the center of the second mesh structure 35 forms a second mesh node 351. In this embodiment, the conductive skeleton 3 has a grid structure, and compared with the solid head end of the conventional ablation catheter, the conductive skeleton 3 has a grid structure, so that blood can be prevented from accumulating at the conductive skeleton 3 to form thrombus during ablation.

In some embodiments, the central grid 32, the first side grid 331, and the second side grid 332 of the conductive skeleton 3 are generally decagonal, i.e., the conductive skeleton 3 in this embodiment may include 11 decagonal grids. Wherein each side of the center grid 32, the first side grid 331, and the second side grid 332 is allowed to have a certain curvature. In other embodiments, the shapes of the central grid 32, the first side grid 331, and the second side grid 332 may be other shapes, such as pentagons, hexagons, circles, etc., which are not strictly limited by the present application.

In some embodiments, a plurality of second electrodes 6 and conductive backbones 3 are used to electrically connect the energy generator of the pulse ablator 30, and a plurality of second electrodes 6 and conductive backbones 3 are each available for ablation. The ablation catheter 10 also includes a plurality of wires (not shown). The first grid node 341 and the second grid node 351 of the conductive framework 3 are respectively provided with a mounting hole 36, the mounting holes 36 are used for mounting the second electrode 6, and the shape of the second electrode 6 is matched with the mounting holes 36. The second electrodes 6 are connected to different wires in a one-to-one correspondence, and then are mounted in mounting holes 36 of the conductive framework 3. The wires connected with the second electrode 6 are suspended at the inner side of the conductive framework 3 and connected with the pulse ablation instrument 30 along the inner side of the inner tube 2. The conductive framework 3 can also be connected into the pulse ablation instrument 30 through a lead wire. In other embodiments, the second electrode 6 may be fixed to the conductive skeleton 3 in other manners, and the conductive skeleton 3 may not be provided with the mounting hole 36. For example, the second electrode 6 may be fixed to the conductive frame 3 by means of engagement, adhesion, lamination, attachment, embedding, or hot pressing, and the present application is not limited thereto. The "inside", "outside" orientation of the conductive frame 3 is a description of the relative orientation in which the direction from the center of the conductive frame 3 to the plate 31 is the "inside" to "outside" direction. For example, the center of the conductive frame 3 is located inside the plate 31, and the plate 31 is located outside the center of the conductive frame 3.

In other embodiments, the first edge mesh 331 of the edge mesh set 33, the second edge mesh 332, and the second edge mesh 332 of the adjacent edge mesh set 33 form a third mesh structure 37, and the center of the third mesh structure 37 also forms a third mesh node 371. The third grid node 371 is also provided with mounting holes 36, which mounting holes 36 may also be used for mounting the second electrode 6, which is not strictly limited in the present application.

In some embodiments, the contact portion of the wire with the conductive frame 3 is provided with an insulating layer (not shown in the figure), and the insulating layer is provided at a portion of the wire suspended inside the conductive frame 3. The insulation between the plurality of wires and the conductive frame 3 can be ensured by coating or wrapping a layer of insulation material on the surfaces of the plurality of wires.

In some embodiments, the second electrode 6 is made of a conductive material, and illustratively, the material of the second electrode 6 may be platinum iridium alloy. The second electrode 6 may include a first portion 61 and a second portion 62, the second portion 62 being connected to the first portion 61 and located at a proximal end of the first portion 61. The second portion 62 of the second electrode 6 is mounted to the mounting hole 36 of the conductive frame 3, and the first portion 61 of the second electrode 6 is located outside the conductive frame 3. Wherein, the contact part of the second electrode 6 and the conductive framework 3 is provided with an insulating layer. Illustratively, the insulation between the second electrode 6 and the conductive frame 3 may be ensured by coating or wrapping an insulating material on the inner side surface of the first portion 61 of the second electrode 6, the outer surface of the second portion 62 of the second electrode 6, or by vacuum coating. In other embodiments, a layer of insulating material may be coated on the mounting hole 36 of the conductive skeleton 3 and the portion where the conductive skeleton 3 contacts the second electrode 6, so as to realize insulation between the conductive skeleton 3 and the plurality of wires and the second electrode 6.

In this embodiment, an insulating layer is disposed at the contact portion between the multiple wires and the conductive framework 3, and an insulating layer is disposed at the contact portion between the second electrode 6 and the conductive framework 3, so that the conductive framework 3 and the second electrode 6 can be separately discharged, and the damage of tissue breakdown caused by short-circuiting between the second electrode 6 and the conductive framework 3 due to direct contact between the conductive framework 3 and the multiple wires and direct contact between the conductive framework 6 and the second electrode 6 is avoided.

Referring to fig. 5 and 7 in combination, fig. 7 is a schematic view of the ablation catheter 10 of fig. 2 at another angle.

In some embodiments, the plurality of second electrodes 6 on the conductive skeleton 3 may be divided into a plurality of second electrode groups 63. The conductive backbone 3 has a central axis, the central axis of the conductive backbone 3 being parallel to the proximal to distal direction of the conductive backbone 3. The plurality of second electrode groups 63 are arranged rotationally symmetrically around the central axis of the conductive skeleton 3, each second electrode group 63 comprising at least two second electrodes 6. And the projection directions of all the second electrodes 6 in the same second electrode group 63 on a first plane, which is perpendicular to the central axis of the conductive skeleton 3, are the same. The plane in which fig. 7 is located may be regarded as a first plane.

In the present embodiment, the plurality of second electrodes 6 of the ablation catheter 10 are divided into a plurality of second electrode groups 63, and the conductive skeleton 3 is also divided into a plurality of regions, one region corresponding to each second electrode group 63. Each second electrode group 63 can be ablated by an individual discharge so that the conductive skeleton 3 can be ablated in zones. Illustratively, the conduction between a portion of the plurality of second electrode sets 63 and the energy generator may be selectively turned off under the control of the pulse ablator 30, and at least one second electrode set 63 may be selected for discharge.

In other embodiments, the plurality of second electrodes 6 may each be individually discharged for ablation. The conduction between some of the plurality of second electrodes 6 and the energy generator may be selectively turned off, while at least one second electrode 6 is selected for discharge. Thereby being convenient for operators to judge the adhesion degree of the second electrode 6 and the target tissue according to the impedance in the treatment process, and the second electrode group 63 with good adhesion is selected for discharge ablation in a targeted way so as to reduce the generation of the thermal effect of the treatment part and control the ablation area and the ablation depth.

In some embodiments, the number of second electrode sets 63 may be five. Each second electrode group 63 may include two second electrodes 6, and the two second electrodes 6 may be represented by a second electrode 631 and a second electrode 632, respectively, according to their positions on the conductive skeleton 3. The second electrode 631 is spaced from the second electrode 632. Wherein the second electrode 631 is fixed to the first grid node 341 of the conductive skeleton 3, and the second electrode 632 is fixed to the second grid node 351 of the conductive skeleton 3. Wherein, the second electrode 631 and the second electrode 632 of the second electrode group 63 can both be used as ablation electrodes. When the ablation catheter 10 is introduced into the heart of a patient for treatment, only a portion of the second electrode 6 on the conductive framework 3 can be well attached to the atrial wall due to the constant beating of the patient's heart, while a portion of the second electrode 6 in the opposite direction may be suspended in the blood and not attached to the atrial wall. Therefore, when the second electrode 6 on the conductive skeleton 3 is well attached to the atrial wall, the attached second electrode 6 can be selected to discharge, the conduction between the other second electrodes 6 and the energy generator is closed, and the ablation is performed by connecting points to form linear or band-shaped lesions at the treatment position, so that the ablation efficiency is improved.

In this embodiment, the second electrode 6 on the conductive skeleton 3 performs the partial discharge, so that the tissue which is not intended to be ablated can be prevented from being damaged. The ablation energy can be applied to the tissue to be ablated in a targeted manner, so that partial pulse energy can be prevented from being discharged and lost by the second electrode 6 in a non-contact area, the energy utilization rate is increased, the dissipation of the energy in the blood is reduced, simultaneously, the air discharge is avoided, and unnecessary bubbles generated by the electrolysis of the blood are reduced. When the subarea discharge is performed, all the second electrodes 6 do not need to be electrified, so that the total current during ablation is reduced, the possible body stimulation is reduced, the short circuit or electric arc caused by the excessive second electrodes 6 can be reduced, and the safety is improved.

In some embodiments, the first electrode 5 on the secondary rod 4 may also be used for electrocardiographic mapping of a target tissue region. The second electrode 6 on the conductive skeleton 3 may also be used for electrocardiographic mapping of the target tissue region. Illustratively, during the movement of the ablation catheter 10, the first electrode 512 on the auxiliary rod 4, the first electrode 513 and the second electrode 6 on the conductive skeleton 3 are most likely to form good abutment with myocardial tissue, so that the first electrode 512 on the auxiliary rod 4, the first electrode 513 and the second electrode 6 on the conductive skeleton 3 can be used as an ablation electrode and a mapping electrode for three-dimensional mapping of electrocardiosignals of a target tissue area, so as to generate a voltage map, an excitation map and find a focus of a local area and a focus of a low voltage area. However, the ablation discharge and mapping of the first electrode 512, the first electrode 513, and the second electrode 6 cannot be performed simultaneously, that is, the first electrode 512, the first electrode 513, and the second electrode 6 cannot discharge pulse current when performing mapping, and electrocardiographic signal mapping cannot be performed during the process of discharging pulse current.

In some embodiments, the first electrode 512 on the auxiliary rod 4, the first electrode 513 and the second electrode 6 on the conductive skeleton 3 may each independently form a mapping channel, and serve as a monopolar mapping electrode for mapping the electrocardiograph signal of the patient to form a monopolar electrogram. In this embodiment, the monopolar mapping electrode may be used to determine whether the activation passes the mapping electrode, and mapping may be performed on the electrocardiographic signal in the 360 ° direction. An operator can select mapping channels in multiple directions according to the three-dimensional mapping result or the actual ablation requirement so as to map electrocardiosignals in a certain direction of a treatment part.

In some embodiments, the plurality of first electrodes 512 on the secondary rod 4, the plurality of first electrodes 513, and the plurality of second electrodes 6 on the conductive skeleton 3 may also respectively form a bipolar mapping channel, which is used as a bipolar mapping electrode for mapping the electrocardiograph signal of the patient to obtain a bipolar electrogram. Illustratively, the first electrode 512 and the first electrode 513 located on the same sub-rod 4 may form a pair of bipolar mapping electrodes, and one bipolar electrogram is obtained, and the five sub-rods 4 may form 6 bipolar electrograms in total. The second electrodes 631 and 632 of the same second electrode group 63 on the conductive skeleton 3 may form a pair of bipolar mapping electrodes to obtain a bipolar electrogram, and all the second electrode groups 63 may form 5 bipolar electrograms. Thus, the entire ablation catheter 10 can form 11 bipolar mapping channels altogether, resulting in 11 bipolar electrograms. It should be noted that the bipolar mapping electrode is composed of two mapping electrodes which do not distinguish between positive and negative electrodes, and the electrocardiograph signal mapping is performed by the two mapping electrodes.

In this embodiment, forming a bipolar mapping electrode from two second electrodes 6 can determine which second electrode 6 is excited closer to, thereby improving mapping accuracy. By mapping the electrocardiographic signals on 11 different mapping channels of the ablation catheter 10, electrocardiographic signal mapping under different conditions of attachment can be adapted to realize omnibearing mapping of the treatment portion, thereby facilitating rapid finding of abnormal excitation origins in the heart, and the detected mapping signals are sent into the three-dimensional mapping system 50 to form a three-dimensional excitation graph, a voltage graph and the like. Under the three-dimensional mapping system 50, the ablation catheter 10 will more precisely reach the designated location for ablation therapy. Taking an excitation graph as an example, color points on the generated excitation graph can move, and the earliest abnormal starting point and the earliest abnormal starting sequence can be found through the excitation graph, so that the abnormal position can be accurately positioned, and the accuracy of ablation treatment is improved.

In other embodiments, the first electrode 513 on the secondary rod 4 may also be used as a mapping electrode for three-dimensional mapping of the electrocardiographic signal of the target tissue region, which is not strictly limited in the present application.

In some embodiments, the three-dimensional mapping system 50 of the present ablation catheter 10 is obtained by combining electric field modeling with electrocardiographic mapping, CT imaging and DSA imaging assisted correction. Six electrode pads are attached to six parts of the neck, thigh, chest, back, left arm, and right arm of the patient to form an electric field (not shown). In addition, an electrode plate is attached to the chest as a reference. And electrifying the electrode plates to form orthogonal electric fields which are orthogonal to each other in the x, y and z three-dimensional directions. The attenuation condition of the electric field in different media is determined by measuring the electric field intensity at the reference position, and the position distance corresponding to different field strengths is determined. When the ablation catheter 10 enters the orthogonal electric field, loops are formed with the internal circuits of the three-dimensional mapping system 50 in the x, y and z directions respectively, and different field strengths in the three directions are measured simultaneously. The position distance of the single second electrode 6 on the ablation catheter 10 in the orthogonal electric field can be obtained through the attenuation equation of the field intensity along with the distance, so that the acquisition point generates a three-dimensional model. However, the image formed by electric field modeling only still contains a lot of noise, and the system can input CT image data and DSA image data. And correcting coordinate values of the image through an algorithm to construct a finer three-dimensional image. Finally, after the ablation catheter 10 collects the electrocardiosignals, data are recorded, and the electrocardiosignals are combined with the three-dimensional model, namely, a complete heart model is formed.

In this embodiment, the distance of the ablation catheter 10 in the three-dimensional electric field can be obtained through electric field modeling, so that the operator can clearly see the position of the ablation catheter 10 through the imaging device. The image formed by modeling the electric field is corrected by combining CT image data and DSA image data with an algorithm, so that the obtained three-dimensional image is finer and more accurate, an operator can conveniently and well operate the ablation catheter 10 to quickly and accurately reach a focus area for ablation treatment, the control difficulty and the use difficulty of the ablation catheter 10 are reduced, and the use experience of the operator on the ablation catheter 10 is improved.

Referring to fig. 4 and 8, fig. 8 is a schematic view of the ablation catheter 10 of fig. 1 in two different use scenarios.

In some embodiments, the inner tube 2 may be made of plastic having self-lubricating properties, and illustratively, the inner tube 2 may be made of Polytetrafluoroethylene (PTFE). The distal end of the inner tube 2 and the distal end of the secondary rod 4 are both movable relative to the outer tube 1. The inner tube 2 moves relative to the outer tube 1 to drive other components to move relative to the outer tube 1. In the present embodiment, polytetrafluoroethylene has excellent high lubrication non-stick properties, so that the frictional resistance between the inner tube 2 and the outer tube 1 is small, and the movement of the inner tube 2 relative to the outer tube 1 is easier.

In some embodiments, the second ablation assembly 102 has a contracted state and an expanded state, the second ablation assembly 102 ablating a target tissue region in the expanded state. At least the outer surface of the auxiliary rod 4 is made of insulating material. By way of example, the secondary rod 4 may be made of an elastic and insulating material, for example, the secondary rod 4 may be made of a thermoplastic polyurethane elastomer (Thermoplastic Urethane, TPU). The distal end of the auxiliary rod 4 is fixed to the distal end of the inner tube 2, and the proximal end of the auxiliary rod 4 is fixed to the distal end of the outer tube 1. The inner tube 2 is movable proximally or distally relative to the outer tube 1 to switch the second ablation assembly 102 between an expanded state and a contracted state. The bending degree of the plurality of auxiliary rods 4 can be adjusted by adjusting the relative positions of the inner tube 2 and the outer tube 1, so that the outer diameter of the basket structure formed by the plurality of auxiliary rods 4 can be adjusted. During the proximal movement of the inner tube 2 relative to the outer tube 1, the inner tube 2 brings the distal end of the secondary rod 4 close to the proximal end of the secondary rod 4, forming a movable portion between the distal end of the conductive skeleton 3 and the distal end of the outer tube 1. When the second ablation assembly 102 is in the expanded state, the middle portion 42 of the secondary rod 4 is away from the central axis of the inner tube 2, and the secondary rod 4 is arc-shaped. Wherein the central axis of the inner tube 2 is parallel to the proximal to distal direction of the ablation catheter 10. The outer diameter of the largest cross section of the basket structure formed by the plurality of auxiliary rods 4 gradually increases in the process that the distal end of the auxiliary rod 4 approaches the proximal end of the auxiliary rod 4. Wherein the maximum cross section of the basket structure is perpendicular to the axial direction of the inner tube 2.

In this embodiment, the auxiliary rod 4 is made of a thermoplastic polyurethane elastomer, which has high tension, high tensile force, toughness and aging resistance, so that wrinkles caused by the change of the curvature of the sheath of the auxiliary rod 4 can be avoided during the bending process of the auxiliary rod 4, which is beneficial to keeping the stable connection between the first electrode 5 and the auxiliary rod 4. In addition, the distance that the distal end of the secondary rod 4 moves toward the proximal end of the secondary rod 4 can be controlled as desired so that the first electrode 5 on the secondary rod 4 can better abut against the tissue at the treatment site, thereby achieving rapid pulmonary vein isolation.

In other embodiments, the auxiliary rod 4 may be made of an elastic metal material, and then an insulating material is coated or covered on the surface of the metal material, where the first electrode 5 is fixed on the auxiliary rod 4 and provided with the insulating material, and the insulating material insulates the auxiliary rod 4 from the first electrode 5. For example, the auxiliary rod 4 may be a nickel titanium metal tube, a woven metal tube, or the like, the surface of which is coated or covered with an insulating layer, which is not strictly limited by the present application.

In some embodiments, when the second ablation assembly 102 is in the contracted state, the middle portion 42 of the auxiliary rod 4 is close to the central axis of the inner tube 2, the auxiliary rod 4 is linear, that is, the plurality of auxiliary rods 4 are parallel to the central axis of the ablation catheter 10, the central axis of the ablation catheter 10 is parallel to the direction from the proximal end to the distal end of the ablation catheter 10, and the basket structure formed by the plurality of auxiliary rods 4 is in a shape of a shuttle. When the distal end of the inner tube 2 moves linearly along the direction of the central axis of the ablation catheter 10 and moves towards the distal end of the outer tube 1, the distal end of the auxiliary rod 4 is driven to move linearly along the direction of the central axis of the ablation catheter 10 and move towards the proximal end of the auxiliary rod 4, wherein when the distance that the distal end of the auxiliary rod 4 moves towards the proximal end of the auxiliary rod 4 is a first stroke, the middle parts 42 of the auxiliary rods 4 are far away from the inner tube 2, and each auxiliary rod 4 is in a general arc shape, so that the basket structure formed by the auxiliary rods 4 is in a general spindle shape; when the distal end of the auxiliary rod 4 moves toward the proximal end of the auxiliary rod 4 by a second stroke (not shown), that is, when the movement stroke is the largest, the distance between the distal end of the auxiliary rod 4 and the proximal end of the auxiliary rod 4 is the smallest, and the auxiliary rod 4 is surrounded to form a ring shape so that the basket structure formed by the plurality of auxiliary rods 4 is substantially petal-shaped, and the ring shape may be substantially perpendicular to the longitudinal axis of the inner tube 2.

Referring to fig. 2,4 and 9, fig. 9 is a schematic view of a portion of the ablation catheter 10 of fig. 1 in another use scenario.

In some embodiments, when the distal end of the inner tube 2 is moved in the direction of the central axis of the ablation catheter 10 toward the distal end of the outer tube 1, the distal end of the auxiliary rod 4 is moved in the direction of the central axis of the ablation catheter 10 in the direction of the proximal end of the auxiliary rod 4. The secondary rods 4 are helical during bending, i.e. each secondary rod 4 has a different twist angle at different positions from the proximal end of the secondary rod 4. Wherein the helix angle of the middle portion 42 of the secondary rod 4 is greater than the helix angle of the proximal end of the secondary rod 4 or the distal end of the secondary rod 4 and the helix angle decreases from the middle portion 42 of the secondary rod 4 to both ends. When the distance by which the distal end of the auxiliary rod 4 moves toward the proximal end of the auxiliary rod 4 is the first stroke, the intermediate portions 42 of the plurality of auxiliary rods 4 move toward the side away from the inner tube 2, the plurality of auxiliary rods 4 are substantially spiral, and the basket structure formed by the plurality of auxiliary rods 4 is substantially spindle-shaped. When the distance by which the distal end of the auxiliary rod 4 moves toward the proximal end of the auxiliary rod 4 is the second stroke, that is, the movement stroke is the largest, the distance between the distal end of the auxiliary rod 4 and the proximal end of the auxiliary rod 4 is the smallest, and the basket structure formed by the plurality of auxiliary rods 4 is substantially petal-shaped. Fig. 9 is a schematic structural view of the ablation catheter 10 after the first ablation assembly 101 is retracted inside the inner tube 2.

In this embodiment, the distal end of the auxiliary rod 4 moves toward the proximal end of the auxiliary rod 4 in a spiral motion, that is, the auxiliary rod 4 is in a spiral shape during bending, so that the auxiliary rod 4 has better compliance, the bending curvature of the auxiliary rod 4 is smaller, the basket structure formed by a plurality of auxiliary rods 4 is convenient to be closely attached to the tissue of the treatment site, and the first electrode 5 positioned at the bearing section 41 or the middle section 42 of the auxiliary rod 4 is positioned on the same plane as much as possible, so as to be better attached to the tissue of the treatment site, thereby helping to improve the efficiency of pulmonary vein isolation.

Referring to fig. 3 and 10 in combination, fig. 10 is a schematic view illustrating an ablation catheter 10 according to the present application in various usage states.

In some embodiments, the outer tube 1 and the inner tube 2 may be made of an elastic material. The infusion catheter 7 may be made of an elastomeric material, and illustratively, the infusion catheter 7 may be made of polyether block polyamide (Polyether block amide, PEBA). In other embodiments, the proximal end of the infusion catheter 7 may be made of an elastic material and the body of the infusion catheter 7 may be made of a metallic material. Wherein the portion of the infusion catheter 7 other than the proximal end is the body of the infusion catheter 7.

In the present embodiment, the outer tube 1 and the inner tube 2 are both made of an elastic material, and the infusion catheter 7 is made of an elastic material or the proximal end of the infusion catheter 7 is made of an elastic material. Thus, the proximal ends of the outer tube 1, the inner tube 2 and the perfusion catheter 7 are all bendable. The proximal ends of the outer tube 1, the inner tube 2 and the irrigation catheter 7 are bendable to a side remote from the central axis of the ablation catheter 10 by a pulling mechanism (not shown) inside the outer tube 1.

In some embodiments, the bending angle θ at which the outer tube 1 is bent to a side away from the central axis of the ablation catheter 10 satisfies: θ is more than or equal to 0 and less than or equal to 90 degrees, and the outer tube 1 can be bent leftwards or rightwards. In other embodiments, the bending angle θ of the outer tube 1 to the side away from the central axis of the ablation catheter 10 is also in other ranges, which the present application is not strictly limited to. In the present embodiment, the degree of bending of the outer tube 1 can be adjusted according to actual needs. Wherein the bending direction of the outer tube 1 can also be regulated. The outer tube 1 can be bent in multiple directions in three-dimensional space, and can be bent according to different structures of the heart of a patient to select a proper treatment position and a proper treatment angle, so that the first ablation assembly 101 and the second ablation assembly 102 of the ablation catheter 10 are better abutted against the treatment position to meet the ablation requirement and the mapping requirement of any position of the heart.

Referring to fig. 2 and 3 in combination, in some embodiments, the first ablation assembly 101 has a contracted state and an expanded state, and the first ablation assembly 101 ablates a target tissue region in the expanded state. The conductive framework 3 can be made of nickel-titanium material, and the conductive framework 3 can be made of laser cutting and shaping by shaping tools. Wherein, the conductive framework 3 of the nickel titanium material has elasticity and flexibility and is a memory deformable structure. The conductive skeleton 3 is thus able to switch between a contracted state and an expanded state. When the conductive frame 3 is in the contracted state, the plurality of plates 31 of the conductive frame 3 are contracted inward, and the conductive frame 3 has a small volume and can be accommodated inside the inner tube 2. When the conductive frame 3 is in the expanded state, the plurality of plates 31 of the conductive frame 3 are expanded outwardly, and the conductive frame 3 has a substantially spherical shape. In this embodiment, the conductive skeleton 3 is a deformable structure, so that the conductive skeleton 3 can well abut against the tissue of the treatment site, so that the first ablation assembly 101 performs discharge ablation.

In some embodiments, the irrigation catheter 7 is slidably mounted inside the inner tube 2, and the conductive skeleton 3 may be fixed to the irrigation catheter 7 on a side near the distal end of the inner tube 2. The ablation catheter 10 further comprises a handle (not shown in the figure), and a pulling mechanism arranged in the handle can drive the perfusion catheter 7 to move relative to the inner tube 2, so that the perfusion catheter 7 can drive the conductive framework 3 to move relative to the inner tube 2, and the conductive framework 3 can extend and retract relative to the inner tube 2. During the movement of the distal end of the infusion catheter 7 towards the distal end of the inner tube 2, the infusion catheter 7 drives the conductive skeleton 3 towards the distal end of the inner tube 2. When the conductive skeleton 3 is in the contracted state, the volume of the conductive skeleton 3 may be small so as to be able to be retracted to the inside of the inner tube 2, so that the conductive skeleton 3 is located inside the inner tube 2, whereby the first ablation assembly 101 is in the contracted state. When the conductive skeleton 3 protrudes from the inner side of the inner tube 2, the conductive skeleton 3 can be converted into an expanded state, the conductive skeleton 3 being located at the distal end of the inner tube 2, so that the first ablation assembly 101 is in the expanded state.

In this embodiment, when the ablation catheter 10 uses only the second ablation assembly 102, both the conductive framework 3 and the irrigation catheter 7 can be accommodated inside the inner tube 2, i.e. the first ablation assembly 101 is in a contracted state, so that the second ablation assembly 102 alone is convenient for discharging. In addition, when the ablation catheter 10 uses the second ablation assembly 102, the first ablation assembly 101 and the perfusion catheter 7 cannot be accommodated inside the inner tube 2, that is, the conductive skeleton 3 is still located at the distal ends of the plurality of auxiliary rods 4, the first ablation assembly 101 is still in the expanded state, at this time, the conductive skeleton 3 can be used for positioning the ablation catheter 10, and the pulse ablation instrument 30 can control only the second ablation assembly 102 of the ablation catheter 10 to be adhered to the treatment site for ablation.

In other embodiments, the conductive framework 3 may be fixed to a fixing ring (not shown in the drawings), the fixing ring is slidably mounted on the inner side of the inner tube 2, and the pulling mechanism may drive the fixing ring to move relative to the inner tube 2, so that the fixing ring can drive the conductive framework 3 to move relative to the inner tube 2, and the conductive framework 3 can extend and retract relative to the inner tube 2, which is not strictly limited in the present application.

In some embodiments, the ablation catheter 10 further includes a reference electrode 8, the reference electrode 8 being located on a proximal side of the conductive backbone 3 when the conductive backbone 3 is in the expanded state. Wherein the proximal side is the side near the proximal end of the ablation catheter 10. The reference electrode 8 is used for electrocardiographic signal mapping to acquire a reference potential. The reference electrode 8 may be fixed to the first connection 43 of the sub rod 4, for example. In other embodiments, the reference electrode 8 may also be fixed to the distal end of the inner tube 2; alternatively, when the first connector 43 is made of an electrically conductive material, the first connector 43 may be used as a reference electrode 8 for the ablation catheter 10, as the application is not limited in this regard. The reference electrode 8 may be made of a conductive material, and illustratively, the material of the reference electrode 8 may be platinum iridium alloy. The lead wire of the reference electrode 8 is arranged on the pipe body of the inner pipe 2 and connected with the pulse ablation instrument 30.

In this embodiment, the plurality of second electrodes 6 fixed to the conductive skeleton 3 and the plurality of first electrodes 512 and 513 on the auxiliary rod 4 can be well abutted against the atrial wall of the patient to be used as mapping electrodes for mapping the electrocardiographic signals of the patient. Although the reference electrode 8 does not rest against the atrial wall, the patient's electrocardiographic signals may also be mapped. The ablation system 100 can obtain more accurate electrical signals according to the difference between the electrical signals mapped by the reference electrode 8 and the electrical signals of the second electrode 6 when the conductive framework 3 is integrally discharged, or the difference between the electrical signals mapped by the reference electrode 8 and the electrical signals when the plurality of first electrodes 512 and the first electrodes 513 on the auxiliary rod 4 are discharged, so as to realize accurate mapping of the electrocardiosignals of the patient. In addition, the reference electrode 8 can also be used as a datum of a three-dimensional mapping image of the ablation catheter 10, and is combined with digital subtraction angiography development, so that the position of the ablation catheter 10 is visible in the three-dimensional mapping image.

Referring to fig. 2, 7 and 8 in combination, in some embodiments, a pulse ablator 30 may be used to control the discharge state of the ablation catheter 10. When the ablation catheter 10 is in the spot ablation mode, the ablation catheter 10 only needs to ablate the treated site using the first ablation assembly 101, and thus the first ablation assembly 101 needs to be controlled to be in an expanded state. That is, the plurality of sub-rods 4 may be arc-shaped, or the plurality of sub-rods 4 may be linear. The first ablation assembly 101 has a plurality of ablation modes.

In some embodiments, the conductive skeleton 3 is conductive, and the conductive skeleton 3 is capable of forming a spherical electric field for punctual ablation of a target tissue region. Wherein, the conductive skeleton 3 and at least one first electrode 5 are paired with each other to form a spherical electric field, or the conductive skeleton 3 and the external negative plate are paired with each other to form a spherical electric field, so as to perform punctiform ablation on a target tissue region. The conductive skeleton 3 can be discharged alone. Illustratively, the conductive backbone 3 may be paired with at least one first electrode 512 and/or at least one first electrode 513 on the secondary rod 4. For example, the conductive frame 3 may be individually set as a positive electrode, at least one first electrode 512 and/or at least one first electrode 513 on the sub-rod 4 are each used as a negative electrode, and the first electrodes 511 are all idle. The conductive skeleton 3 forms a positive and negative electrode loop with the at least one first electrode 512 and/or the at least one first electrode 513. The first electrode 512 and/or the first electrode 513 on the secondary rod 4 are selected to mate with the conductive backbone 3 because the first electrode 512 and the first electrode 513 on the secondary rod 4 are most likely to form a good abutment with the myocardial tissue, thereby facilitating the discharge ablation of the first ablation assembly 101.

Wherein the conductive skeleton 3 and the at least one second electrode 6 are paired with each other to form a spherical electric field for punctiform ablation of a target tissue region. Illustratively, one of the conductive skeleton 3 and the at least one second electrode 6 is provided as a positive electrode, the other is provided as a negative electrode, and a positive-negative circuit is formed between the at least one second electrode 6 and the conductive skeleton 3.

Wherein the second electrodes 6 can be individually discharged, and at least one second electrode 6 and at least one first electrode 5 are paired with each other to form a local electric field for local ablation of the target tissue region. Illustratively, the at least one second electrode 6 may be paired with at least one first electrode 512 and/or at least one first electrode 513 on the secondary rod 4. For example, at least one second electrode 6 may be set as a positive electrode, at least one first electrode 512 and/or at least one first electrode 513 on the secondary rod 4 are each used as a negative electrode, and the first electrodes 511 are all idle. A positive-negative electrode circuit is formed between the at least one second electrode 6 and the at least one first electrode 512 and/or the at least one first electrode 513.

Wherein, the conductive skeleton 3 and the at least one second electrode group 63 can be discharged together, and the conductive skeleton 3, the at least one second electrode group 63 and the at least one first electrode 5 are mutually paired to form a local electric field so as to perform local ablation on the target tissue region. Illustratively, the conductive skeleton 3 and the second electrode 6 of the at least one second electrode group 63 are both used as positive electrodes, the at least one first electrode 512 and/or the at least one first electrode 513 on the plurality of secondary rods 4 are both used as negative electrodes, and the first electrodes 511 are all idle. A positive-negative electrode circuit is formed between the conductive skeleton 3, the second electrode 6 of the at least one second electrode set 63, and the at least one first electrode 512 and/or the at least one first electrode 513. The positive electrode and the negative electrode are connected into the pulse ablation instrument 30, when the pulse ablation instrument 30 emits pulse energy, a pulse electric field is formed between the positive electrode and the negative electrode, and irreversible electroporation damage is formed on target tissues of a treatment part. Under a pulsed electric field, the first ablation assembly 101 may form a punctiform ablation zone.

In this embodiment, the conductive skeleton 3 serves as a positive electrode, and at least one first electrode 5 serves as a negative electrode; or at least one second electrode 6 and the conductive framework 3 are paired to form a positive and negative electrode loop; or at least one second electrode 6 as positive electrode and at least one first electrode 5 as negative electrode; or the conductive skeleton 3 and the at least one second electrode group 63 serve as positive electrodes, and the at least one first electrode 5 serves as negative electrodes, the ablation catheter 10 of the present application does not require an additional negative plate for attaching to the back of the patient, compared to the prior art. The positive electrode and the negative electrode of the ablation catheter 10 are used for ablation to form bipolar pulse ablation, and on one hand, the external negative plate is omitted in a bipolar pulse ablation mode, so that muscle stimulation is reduced, and the ablation effect is improved. On the other hand, the current generated by the discharge of the conductive skeleton 3 or the current generated by the discharge of the conductive skeleton 3 and the plurality of second electrodes 6 is directly transmitted to the second first electrode 512 and the third first electrode 513 through the tissue of the patient, and finally returns to the ablation system 100 through the lead wire to form a loop, so that the distance between the positive electrode and the negative electrode is shorter, the energy consumption of the ablation catheter 10 during the ablation is less, and the ablation speed is faster.

In other embodiments, the conductive framework 3 may be paired with an external negative plate, the conductive framework 3 may be separately set as a positive electrode, and a positive-negative circuit is formed between the conductive framework 3 and the negative plate, which is not strictly limited in the present application.

In some embodiments, the pulse ablator 30 may control the one or more second electrode sets 63 on the conductive backbone 3 to perform a zone discharge. For example, one second electrode group 63 on the conductive skeleton 3 may be discharged individually, i.e., the second electrodes 6 in one second electrode group 63 are discharged simultaneously, while the second electrodes 6 in the other second electrode groups 63 and the conductive skeleton 3 do not participate in the discharge. Illustratively, a plurality of second electrode groups 63 in one region of the conductive skeleton 3 may be discharged at the same time, and the second electrode groups 63 in other regions and the conductive skeleton 3 do not participate in the discharge. When the second electrode group 63 on the conductive skeleton 3 is subjected to the zone discharge, the second ablation assembly 102 may be in a contracted state, that is, the plurality of auxiliary shafts 4 need to be adjusted to be in a shuttle shape, and the plurality of auxiliary shafts 4 need to be adjusted to be in a shuttle shape, so that the size of the ablation catheter 10 can be reduced to facilitate better passage through the blood vessel. The second electrode 6 of the second electrode group 63, which performs the discharge, is provided as a positive electrode, and at least one first electrode 5 as a negative electrode. Illustratively, when the second electrode 6 in the one or more second electrode groups 63 of a certain region is discharged, the second electrodes 6 in the second electrode groups 63 that are discharged are all set as positive electrodes, at least one first electrode 512 and/or at least one first electrode 513 on the plurality of sub-rods 4 are set as negative electrodes, and the first electrodes 511 are all idle. The discharged second electrode set 63 forms a local electric field with the at least one first electrode 512 and/or the at least one first electrode 513, forming a spot-shaped ablation zone.

In this embodiment, when the conductive skeleton 3 is discharged to perform dotting ablation, if a deep ablation depth is required to be formed at each point according to actual clinical requirements, the his bundle is easily damaged when dotting scribing ablation is performed at the mitral isthmus of the heart, resulting in atrioventricular block. While the conductive skeleton 3 is not discharged, when the second electrode group 63 on the conductive skeleton 3 performs the partition discharge, the depth of the ablation damage can be increased due to the reduction of the discharge area during the partition discharge under the condition that the ablation parameters are the same. Meanwhile, when the second electrode group 63 on the conductive skeleton 3 performs the partitioned discharge, the discharge direction is selectable, so that the discharge can be avoided from being performed by the his bundle, so as to avoid the his bundle from being damaged, and further prevent the occurrence of adverse events.

In some embodiments, when the second ablation assembly 102 performs discharge ablation, two adjacent first electrode groups 51 on two adjacent auxiliary rods 4 may be respectively set as positive electrodes and negative electrodes, that is, six first electrode groups 51 on six auxiliary rods 4 are set as three positive electrodes and three negative electrodes, and the positive electrodes and the negative electrodes are alternately set. In this embodiment, an electric field is formed between two adjacent first electrode groups 51 on every two adjacent auxiliary rods 4, so that an electric field in six directions can be formed, which is beneficial to forming large-area lesions and rapidly completing pulmonary vein isolation.

In some embodiments, each secondary rod 4 of the second ablation assembly 102 may be individually discharged. When a certain tissue area of the patient needs to be ablated by the second ablation assembly 102, the second ablation assembly 102 needs to be in an expanded state, i.e. the bending curvature of the secondary rod 4 is adjusted, so that the secondary rod 4 is abutted against the atrial wall, so as to improve the abutment of the second ablation assembly 102. The first electrode group 51 on the part of the auxiliary rod 4 with good adhesion with the atrial wall can be selected to discharge, and the conduction between the first electrode 5 on the other auxiliary rod 4 and the energy generator is closed. For example, the first electrode group 51 on two adjacent sub-rods 4 may be selected to discharge, the first electrode group 51 on one sub-rod 4 is set as a positive electrode, the first electrode group 51 on the other sub-rod 4 is set as a negative electrode, the first electrode group 51 on the other sub-rod 4 does not participate in the discharge, and an electric field is formed only between the two adjacent sub-rods 4, thereby forming a linear damage region. Alternatively, a part of the first electrode group 51 on the sub-rod 4 may be selected for discharge, and another part of the first electrode group 51 on the sub-rod 4 does not participate in discharge. In a part of the auxiliary rods 4 involved in the discharge, the first electrode group 51 on at least one auxiliary rod 4 is set as a positive electrode, the first electrode group 51 on at least one auxiliary rod 4 is set as a negative electrode, the first electrode group 51 on the remaining auxiliary rods 4 can be set as a positive electrode or a negative electrode, and at the same time, the positive electrode and the negative electrode of the first electrode group 51 on the auxiliary rod 4 can be adjusted according to the structure of the target tissue, and an electric field is formed between the part of the auxiliary rods 4 involved in the discharge.

In the present embodiment, a part of the sub-rod 4 is selected to discharge, so that the plurality of first electrode groups 51 can be prevented from damaging the tissue which is not intended to be ablated. The ablation energy can be applied to the tissue to be ablated in a targeted manner, so that partial pulse energy can be prevented from being discharged and lost by the first electrode group 51 in the non-contact area, the utilization rate of the energy is increased, the dissipation of the energy in blood is reduced, simultaneously, the air discharge is avoided, and unnecessary bubbles generated by the electrolysis of the blood are reduced. In addition, when the ablation parameters are the same, the discharge area when part of the sub-rod 4 is discharged is reduced, so that a deeper ablation lesion can be formed. When partial auxiliary rod 4 is discharged in a partitioned mode, all the first electrode groups 51 do not need to be electrified, the total current during ablation is reduced, possible body stimulation is reduced, short circuits or electric arcs caused by excessive first electrode groups 51 can be reduced, and safety is improved.

In some embodiments, when the ablation catheter 10 only needs to use the first ablation assembly 101, the outer tube 1, the inner tube 2 and the second ablation assembly 102 can be all accommodated inside the ablation sheath (not shown in the figure), or the plurality of auxiliary rods 4 are adjusted to be in a linear state, so that the second ablation assembly 102 is in a contracted state, and only the conductive skeleton 3 and the second electrode 6 are positioned at the distal end of the ablation sheath, and at the moment, the conductive skeleton 3 is in an expanded state, that is, the first ablation assembly 101 is in an expanded state, so that the first ablation assembly 101 can form good abutment with the tissue of the treatment site, and the ablation catheter 10 can perform dotting ablation independently. When only the second ablation assembly 102 of the ablation catheter 10 is needed, the pulling mechanism can be operated by the handle to retract the conductive framework 3 and the infusion catheter 7 inside the inner tube 2 so that the first ablation assembly 101 is in a contracted state. Simultaneously, the distal end of the inner tube 2 can be controlled to move towards the outer tube 1 to drive the auxiliary rod 4 to be in different bending states, so that the second ablation assembly 102 is in an expanding state, and good adhesion is formed between the first electrode 5 on the auxiliary rod 4 and tissues of a part to be treated, thereby being more beneficial to the discharge ablation of the first electrode 5 and improving the ablation efficiency.

In this embodiment, when the ablation catheter 10 only needs to use the first ablation assembly 101, only the first ablation assembly 101 can be controlled to abut the tissue at the treatment site in order to better achieve the dotting ablation. When only the second ablation assembly 102 of the ablation catheter 10 is needed, only the second ablation assembly 102 may be controlled to abut tissue at the treatment site in order to better achieve annular ablation. Therefore, the ablation catheter 10 in this embodiment can realize the switching between the single dotting ablation function and the single annular ablation function of the ablation catheter 10 by the extension and retraction of the second ablation assembly 102 relative to the ablation sheath and the extension and retraction of the conductive framework 3 relative to the inner tube 2, so as to avoid the mutual interference between the first ablation assembly 101 and the second ablation assembly 102.

In other embodiments, when the ablation catheter 10 only requires use of the first ablation assembly 101, the plurality of secondary rods 4 may also be adjusted to an arcuate state such that the second ablation assembly 102 is in an expanded state. The first ablation assembly 101 may also be adjusted to be in an expanded state when only the second ablation assembly 102 of the ablation catheter 10 is needed, as the application is not limited in this regard.

In some use scenarios, the ablation catheter 10 in this embodiment may be used to treat persistent atrial fibrillation. For patients with persistent atrial fibrillation with multiple triggers, an instrument capable of achieving both pulmonary vein isolation and dash-dot line isolation functions must be used in the operation. The present embodiment provides a combined multifunctional dotting pulse ablation catheter 10, which has a rapid pulmonary vein isolation function, and can exclude pulmonary vein triggers, so that an operator can more concentrate on solving ganglion slave, multiple wavelets (or rotors), non-pulmonary vein triggers, autonomic nerves, atrial fibrillation matrix and other triggers.

Referring to fig. 1, 2 and 7 again, the treatment method of the ablation catheter 10 in this embodiment may be, for example: first, preoperative preparation, including equipment wiring, patient table-up, sterilization, etc. The femoral vein of the patient is then punctured. After the femoral vein puncture is completed, the heart-atrial septum of the patient is punctured. After the atrial septum puncture is completed, an ablation large sheath of the pulse ablation device can be used, and after the ablation large sheath enters the left atrium, the ablation catheter 10 is inserted into the ablation large sheath and enters the left atrium through the inner cavity of the ablation large sheath. After the ablation catheter 10 reaches the left atrium, three-dimensional mapping is performed first, and after mapping is completed, the pulmonary veins are isolated by the second ablation assembly 102. After pulmonary vein isolation is completed, the mitral isthmus line and the left roof line are isolated by a first ablation assembly 101, and the abnormal activation point or focal zone is ablated. When the left atrial ablation procedure is completed, the ablation sheath and ablation catheter 10 is withdrawn from the left atrium to the right atrium, isolating the tricuspid isthmus by the second ablation assembly 102. And (3) performing three-dimensional mapping again after isolation is completed, verifying electric signal conduction, and ending the operation after the electric signal conduction is verified successfully.

Referring to fig. 11 and 12 in combination, fig. 11 is a schematic view of a portion of an ablation catheter 10 according to another embodiment of the present application, and fig. 12 is a schematic view of a cross-section of the ablation catheter 10 shown in fig. 11 taken along line C-C.

In some embodiments of the present application, the ablation catheter 10 may include an outer tube 1, an inner tube 2, a first ablation assembly 101, a second ablation assembly 102, an irrigation catheter 7, and a reference electrode 8. The first ablation assembly 101 may include a conductive backbone 3 and a plurality of second electrodes 6, and the second ablation assembly 102 may include a plurality of secondary shafts 4 and a plurality of first electrodes 5. The structures of the outer tube 1, the inner tube 2, the conductive skeleton 3, the auxiliary rod 4, the first electrode 5, the second electrode 6, the perfusion catheter 7 and the reference electrode 8 may be referred to the related descriptions of the foregoing embodiments, and will not be repeated herein.

In some embodiments, the proximal end of the conductive framework 3 may be secured to the distal end of the inner tube 2. The perfusion catheter 7 is located inside the inner tube 2, the conductive backbone 3 is located at the distal end of the inner tube 2, and the reference electrode 8 is located at the proximal end of the conductive backbone 3. When the ablation catheter 10 only needs to use the first ablation assembly 101, the outer tube 1, the inner tube 2 and the second ablation assembly 102 can be contained inside an ablation sheath (not shown in the figure), only the conductive skeleton 3 and the second electrode 6 are located at the distal end of the ablation sheath, and the conductive skeleton 3 is in an expanded state at this time, so that the first ablation assembly 101 is in an expanded state, and the first ablation assembly 101 can form good contact with the tissue of the treatment site, so that the ablation catheter 10 can perform dotting ablation independently. When the ablation catheter 10 only needs to use the second ablation assembly 102, the ablation catheter 10 can be pushed out of the ablation sheath entirely, and the pulse ablator 30 can control only the second ablation assembly 102 to discharge, while the first ablation assembly 101 formed by the conductive framework 3 is not discharged, so that annular ablation of the pulmonary veins and other parts can be realized.

In the present embodiment, since the proximal end of the conductive frame 3 is directly fixed to the distal end of the inner tube 2, the conductive frame 3 cannot be accommodated inside the inner tube 2 even if the conductive frame 3 is in a compressed state. Thus, when the second ablation assembly 102 is performing ablation, the conductive backbone 3 is still located on the distal side of the secondary shaft 4. The pulse ablator 30 can still control the discharge of only the first ablation assembly 101 and only the second ablation assembly 102 of the ablation catheter 10, so that the discharge of the first ablation assembly 101 and the discharge of the second ablation assembly 102 are not interfered with each other, and the dotting ablation and the annular ablation can be performed respectively.

Referring to fig. 13, fig. 13 is a schematic view of a portion of an ablation catheter 10 according to another embodiment of the present application.

In some embodiments of the present application, the ablation catheter 10 may include an outer tube 1, an inner tube 2, a first ablation assembly 101, a second ablation assembly 102, an irrigation catheter 7, and a reference electrode 8. The first ablation assembly 101 may include a conductive backbone 3 and a plurality of second electrodes 6, and the second ablation assembly 102 may include a plurality of secondary shafts 4 and a plurality of first electrodes 5. The structures of the outer tube 1, the inner tube 2, the conductive skeleton 3, the second electrode 6, the perfusion catheter 7 and the reference electrode 8 may be referred to in the related description of the foregoing embodiments, which will not be repeated herein, and only the structure of the auxiliary rod 4 in this embodiment is different from the foregoing embodiments.

In some embodiments, the secondary rod 4 is made of an electrically conductive material. For example, the auxiliary rod 4 may be made of an elastic metal material such as nickel-titanium alloy, which is not strictly limited by the present application. The ablation catheter 10 further comprises a plurality of wires (not shown in the figure) connected to the plurality of auxiliary rods 4 in a one-to-one correspondence, that is, the plurality of auxiliary rods 4 are connected to the pulse ablator 30 by wires. A plurality of secondary rods 4 may be used for discharge ablation. A plurality of auxiliary rods 4 are provided around the inner tube 2, and the plurality of auxiliary rods 4 are spaced apart from each other. Wherein the number of secondary bars 4 may be three, four, six, eight or other suitable number. Illustratively, the number of secondary rods 4 is six, and the six secondary rods 4 are equally spaced so as to achieve omnidirectional ablation of the pulmonary veins.

In this embodiment, the plurality of auxiliary rods 4 can be discharged, and the second ablation assembly 102 including the plurality of auxiliary rods 4 can realize annular ablation of the ablation catheter 10. Each secondary shaft 4 of the ablation catheter 10 may be individually discharged. The second ablation assembly 102 of the ablation catheter 10 may form six discharge regions altogether. In addition, all of the secondary rods 4 of the ablation catheter 10 may also be discharged simultaneously to form an annular lesion, thereby enabling rapid ablation of the mitral isthmus, tricuspid isthmus, left atrial apex line, left atrial posterior wall line, fragmentation potential zone, large annulus surrounding the pulmonary vein, etc.

In other embodiments, the secondary rod 4 may be made of a conductive material and may be coated or covered with an insulating material on a portion of the surface of the conductive material. For example, the auxiliary rod 4 may be made of an elastic metal material such as nickel-titanium alloy, and an insulating material may be coated or clad on a part of the surface of the metal material. The portion of the surface of the sub-rod 4 not coated or covered with the insulating material is used for discharge, and the present application is not limited thereto.

Referring to fig. 13 and 14, fig. 14 is a schematic view of the ablation catheter 10 of fig. 13 at another angle.

In some embodiments, the secondary rod 4 may not participate in mapping of the patient's cardiac signal when the secondary rod 4 is used as an electrical conductor for discharge ablation. The plurality of second electrodes 6 on the conductive skeleton 3 in the ablation catheter 10 may each form a mapping channel separately for mapping the electrocardiographic signals of the patient to obtain a unipolar electrogram, or a bipolar mapping channel is formed between every two of the plurality of second electrodes 6 on the conductive skeleton 3, and illustratively, two second electrodes 6 located in the same second electrode group 63 form a pair of bipolar mapping electrodes for mapping the electrocardiographic signals of the patient to obtain a bipolar electrogram. And the reference electrode 8 may be used as an auxiliary mapping electrode to map the patient's cardiac signal. In this embodiment, the plurality of second electrodes 6 on the conductive skeleton 3 are uniformly distributed, and can realize mapping of electrocardiographic signals in the 360 ° direction, so that the ablation catheter 10 can still realize good mapping effect.

In some embodiments, the pulsed ablator 30 may be used to control the discharge state of the ablation catheter 10. When the ablation catheter 10 is in the spot ablation mode, the ablation catheter 10 need only be used with the first ablation assembly 101, the first ablation assembly 101 need be in an expanded state, and the plurality of secondary shafts 4 may be adjusted to be shuttle-like to place the second ablation assembly 102 in a contracted state. Only the first ablation assembly 101 is positioned against the treatment site to ablate the site in need of treatment. The conductive skeleton 3 has conductivity, and the conductive skeleton 3 can form a spherical electric field to perform punctiform ablation on a target tissue region. Illustratively, the conductive backbone 3 and/or the at least one second electrode 6 are paired with the secondary shaft 4 in electrical connection with the energy generator to deliver pulsed ablation energy output by the energy generator to the target tissue region. The conductive skeleton 3 can be discharged alone. Illustratively, the conductive skeleton 3 and the at least one secondary rod 4 are paired with each other to form a spherical electric field. For example, the conductive frame 3 may be separately provided as a positive electrode, at least one sub-rod 4 is used as a negative electrode, and a positive-negative electrode circuit is formed between the conductive frame 3 and the at least one sub-rod 4.

Wherein the conductive skeleton 3 can be discharged together with the at least one second electrode 6, and the conductive skeleton 3, the at least one second electrode 6 and the at least one auxiliary rod 4 are mutually paired to form a local electric field so as to perform local ablation on the target tissue region. Illustratively, the conductive skeleton 3 and at least one second electrode 6 are both used as positive electrodes, and at least one secondary rod 4 is provided as negative electrode. A positive and negative electrode loop is formed among the conductive framework 3, the at least one second electrode 6 and the at least one auxiliary rod 4.

Wherein the second electrodes 6 can be individually discharged, and at least one second electrode 6 and at least one secondary rod 4 are paired with each other to form a local electric field for local ablation of the target tissue region. Illustratively, at least one second electrode 6 may be provided as a positive electrode, at least one secondary rod 4 being used as a negative electrode, and a positive-negative electrode circuit being formed between the at least one second electrode 6 and the at least one secondary rod 4.

Furthermore, the conductive skeleton 3 and the at least one second electrode 6 are paired with each other to form a spherical electric field for punctiform ablation of the target tissue region. Illustratively, one of the conductive skeleton 3 and the at least one second electrode 6 is provided as a positive electrode, the other is provided as a negative electrode, and a positive-negative circuit is formed between the at least one second electrode 6 and the conductive skeleton 3. The positive electrode and the negative electrode are connected with an energy generator of the pulse ablation instrument 30, and when the pulse ablation instrument 30 emits pulse energy, a spherical electric field is formed between the positive electrode and the negative electrode, so that irreversible electroporation damage is formed on target tissues of a treatment part. Under a spherical electric field, the first ablation assembly 101 may form a punctiform ablation zone.

In this embodiment, the conductive skeleton 3 serves as a positive electrode, and at least one sub-rod 4 serves as a negative electrode; or at least one second electrode 6 and the conductive framework 3 are paired to form a positive and negative electrode loop; or at least one second electrode 6 as positive electrode and at least one secondary rod 4 as negative electrode; or the conductive skeleton 3 and the at least one second electrode group 63 serve as positive electrodes, and the at least one first electrode 5 serves as negative electrodes, the ablation catheter 10 of the present application does not require an additional negative plate for attaching to the back of the patient, compared to the prior art. The positive electrode and the negative electrode of the ablation catheter 10 are used for ablation to form bipolar pulse ablation, and on one hand, the external negative plate is omitted in a bipolar pulse ablation mode, so that muscle stimulation is reduced, and the ablation effect is improved. On the other hand, the current generated by the discharge of the conductive skeleton 3 or the current generated by the discharge of the conductive skeleton 3 and the plurality of second electrodes 6 is directly transmitted to the plurality of auxiliary rods 4 through the tissue of the patient, and finally returns to the ablation system 100 through the lead wire to form a loop, and the distance between the conductive skeleton 3 and the auxiliary rods 4 is shorter. Thus, the ablation catheter 10 consumes less energy during ablation and ablates faster.

In some embodiments, the conductive skeleton 3 and/or at least one second electrode set 63 are paired with the secondary shaft 4 to be electrically connected to an energy generator to deliver pulsed ablation energy output by the energy generator to the target tissue region. Specific embodiments may refer to the above-mentioned pairing manner of the conductive skeleton 3 and/or the at least one second electrode 6 and the auxiliary rod 4, which is not described herein.

Referring again to fig. 13 and 14, in some embodiments, when the second ablation assembly 102 performs discharge ablation, the second ablation assembly 102 is placed in an expanded state, two adjacent auxiliary rods 4 are respectively set as positive and negative electrodes, that is, six auxiliary rods 4 are respectively set as three positive and three negative electrodes, and the positive and negative electrodes are alternately set. In this embodiment, an electric field is formed between every two adjacent auxiliary rods 4, so that six electric fields can be formed in total, which is beneficial to forming large-area injury and rapidly completing pulmonary vein isolation.

In some embodiments, when ablation of a tissue region of a patient is desired, the bending curvature of the secondary rod 4 is adjusted so that the secondary rod 4 abuts the atrial wall. A portion of the secondary rod 4 with good abutment with the atrial wall may be selected for discharge, closing the conduction between the other secondary rods 4 and the energy generator. For example, two adjacent sub-rods 4 may be selected to discharge, one of the sub-rods 4 is set as a positive electrode, the other sub-rod 4 is set as a negative electrode, and the other sub-rods 4 do not participate in the discharge, and an electric field is formed only between the two adjacent sub-rods 4, thereby forming a linear damage region. Or a part of the auxiliary rod 4 may be selected for discharge, and another part of the auxiliary rod 4 does not participate in discharge. Among the sub-rods 4, at least one sub-rod 4 is a positive electrode, at least one sub-rod 4 is a negative electrode, the remaining sub-rods 4 may be positive electrodes or negative electrodes, and the positive and negative electrodes of the sub-rods 4 may be adjusted according to the structure of the target tissue, thereby forming an electric field between the sub-rods 4.

In the present embodiment, a part of the sub-rods 4 is selected for discharge, and it is possible to avoid that a plurality of sub-rods 4 are discharged together to damage the tissue which is not intended to be ablated. The ablation energy can be applied to the tissue to be ablated in a targeted manner, so that partial pulse energy can be prevented from being lost by the discharge of the auxiliary rod 4 in a non-contact area, the energy utilization rate is increased, the dissipation of the energy in blood is reduced, simultaneously, the air discharge is avoided, and unnecessary bubbles generated by the electrolysis of the blood are reduced. In addition, when the ablation parameters are the same, the discharge area when part of the sub-rod 4 is discharged is reduced, so that a deeper ablation lesion can be formed. When part of the auxiliary rods 4 are discharged, all the auxiliary rods 4 do not need to be electrified, so that the total current during ablation is reduced, and possible body irritation is reduced.

The foregoing has outlined and described in detail the basic principles and features of the present application and their advantages. Those skilled in the art will appreciate that the application is not limited to the above-described structural examples and embodiments described herein, but rather, the application is capable of other modifications and improvements without departing from the spirit and scope of the application as claimed.

Claims

1. An ablation catheter, characterized in that,

An outer tube;

The inner pipe is coaxially and movably arranged in the outer pipe in a penetrating way;

The first ablation assembly is arranged at the distal end of the inner tube and is used for performing punctiform ablation on a target tissue region;

The second ablation assembly is arranged at the proximal end of the first ablation assembly, the proximal end of the second ablation assembly is connected with the distal end of the outer tube, and the second ablation assembly is used for performing annular ablation on a target tissue area.

2. The ablation catheter of claim 1, wherein the first and second ablation assemblies each have a contracted state and an expanded state, wherein the first and second ablation assemblies each ablate a target tissue region in the expanded state, and wherein the second ablation assembly is in either the contracted state or the expanded state when the first ablation assembly is in the expanded state; when the second ablation assembly is in an expanded state, the first ablation assembly is in a contracted state or an expanded state.

3. The ablation catheter of claim 2, wherein the second ablation assembly comprises a plurality of secondary shafts disposed about the inner tube and spaced apart from one another, a distal end of each secondary shaft being secured to the distal end of the inner tube and a proximal end of each secondary shaft being secured to the distal end of the outer tube.

4. The ablation catheter of claim 3, wherein the second ablation assembly further comprises a plurality of first electrodes disposed on the secondary shaft, the plurality of first electrodes capable of forming an electric field in a ring shape to perform annular ablation of a target tissue region.

5. The ablation catheter of claim 4, wherein the secondary shaft includes a carrier section disposed adjacent a distal end thereof, the first electrode disposed on the carrier section.

6. The ablation catheter of claim 4, wherein the polarity of the first electrodes on the same secondary shaft is the same, and in adjacent secondary shafts, the first electrodes are arranged in one-to-one correspondence along the axial direction of the second ablation assembly and the polarities of the corresponding first electrodes are opposite;

The first electrodes surround at least one ring in the circumferential direction of the second ablation assembly, and each ring forms an annular electric field to perform annular ablation on a target tissue region.

7. The ablation catheter of claim 3, wherein the inner tube is movable proximally or distally relative to the outer tube to switch the second ablation assembly between an expanded state and a contracted state; when the second ablation assembly is in an expanded state, the middle part of the auxiliary rod is far away from the central axis of the inner tube, the auxiliary rod is arc-shaped, or the proximal end and the distal end of the auxiliary rod are gathered, and the auxiliary rod is surrounded to form a ring shape; when the second ablation assembly is in a contracted state, the middle part of the auxiliary rod is close to the central axis of the inner tube, and the auxiliary rod is linear.

8. The ablation catheter of claim 3, wherein a plurality of the secondary rods are symmetrically arranged about the axis of the inner tube.

9. The ablation catheter of claim 3, further comprising a first connector fixedly connected to the distal ends of the plurality of secondary shafts and fixedly connected to the distal ends of the inner tube, and a second connector fixedly connected to the proximal ends of the plurality of secondary shafts and fixedly connected to the distal ends of the outer tube.

10. The ablation catheter of claim 4 or 5, wherein the first ablation assembly comprises a conductive backbone movably mounted to the distal end of the inner tube, the first ablation assembly being in a contracted state when the conductive backbone is contracted inside the inner tube; when the conductive framework is exposed out of the inner tube, the first ablation assembly is in an expanded state, the conductive framework has conductivity, and the conductive framework can form a spherical electric field so as to perform punctiform ablation on a target tissue region.

11. The ablation catheter of claim 10, wherein the conductive backbone and at least one of the first electrodes are paired to form a spherical electric field or the conductive backbone and the extra-corporeal negative plate are paired to form a spherical electric field for punctual ablation of a target tissue region.

12. The ablation catheter of claim 10, wherein the first ablation assembly further comprises a plurality of electrode sets disposed on the conductive backbone, the plurality of electrode sets being rotationally arranged about a central axis of the conductive backbone, each electrode set comprising at least two second electrodes for electrocardiograph mapping of a target tissue region.

13. The ablation catheter of claim 12, wherein the conductive framework comprises a central lattice and a plurality of edge lattice sets, the central lattice is located at a distal end of the conductive framework, a center of the central lattice is located on a central axis of the ablation catheter, the central lattice is polygonal, and the plurality of edge lattice sets are circumferentially disposed about the central lattice and rotationally symmetrically arranged about the central axis.

14. The ablation catheter of claim 13, wherein each of the edge grid sets comprises a first edge grid and a second edge grid, adjacent two of the first edge grids and the center grid form a first grid structure, a center of the first grid structure forms a first grid node, the first edge grid of the edge grid set, the second edge grid, and the first edge grid of the adjacent edge grid set form a second grid structure, a center of the second grid structure forms a second grid node; each electrode group comprises two second electrodes, and the two second electrodes are respectively fixed on the first grid node and the second grid node.

15. The ablation catheter of any of claims 12-14, wherein the second electrode is further configured for ablation, the conductive backbone and at least one of the second electrodes being paired with one another to form a spherical electric field for punctual ablation of a target tissue region.

16. The ablation catheter of any of claims 12-14, wherein the second electrodes are further configured for ablation, at least one of the second electrodes paired with at least one of the first electrodes to form a localized electric field for localized ablation of a target tissue region.

17. The ablation catheter of claim 12, wherein the first electrode is further for electrocardiographic mapping of a target tissue region.

18. The ablation catheter of claim 12, further comprising a reference electrode located proximal to the conductive backbone, the reference electrode for electrocardiograph mapping to obtain a reference potential.

19. The ablation catheter of claim 10, further comprising an irrigation catheter positioned inside the inner tube and a distal end of the irrigation catheter positioned inside the conductive backbone, the irrigation catheter being for irrigation of an irrigation liquid into the conductive backbone.

20. An ablation system comprising a pulsed ablation device and the ablation catheter of any of claims 1-19, the ablation catheter being connected to the pulsed ablation device.