Ablation catheters and ablation systems

Abstract

The present application provides an ablation catheter and an ablation system, wherein the ablation catheter comprises: a catheter body; a support frame, which is arranged at the distal end of the catheter body, the support frame defines an equatorial position, and the support frame comprises a first frame and a second frame, the second frame is arranged at the distal end relative to the first frame, the proximal end of the first frame is connected to the distal end of the catheter body, the distal end of the first frame is connected to the proximal end of the second frame, and the first frame is entirely or partially arranged as a conductive part; at least one ablation electrode is arranged on the second frame, and is located between the equatorial position and the distal end of the second frame; at least one mapping electrode is arranged on the second frame, and is located at the equatorial position or between the equatorial position and the proximal end of the second frame. The ablation catheter has both mapping and ablation functions, and the ablation catheter can not only ensure the ablation effect and improve the ablation depth, but also improve the mapping efficiency and effect and ensure the mapping accuracy.

Description

Technical Field

[0001] The present application relates to the field of medical devices, and in particular to an ablation catheter and an ablation system. Background Art

[0002] With the continuous development of medical technology and the advancement of minimally invasive interventional devices, the field of electrophysiology has gradually received more attention. The devices related to cardiac electrophysiological interventional technology mainly include mapping catheters, ablation catheters and other electrophysiological interventional devices.

[0003] Currently, when designing a catheter to treat atrial fibrillation, what is usually considered is to base the mapping and ablation functions on an integrated skeleton structure design. However, the related mapping and ablation functions based on an integrated skeleton structure design often finds it difficult to ensure both the efficiency and effectiveness of mapping and ablation. Summary of the invention

[0004] One purpose of the present application is to provide an ablation catheter, which has both mapping and ablation functions, and can not only increase the ablation depth and ensure the ablation effect, but also improve the mapping effect and ensure the mapping accuracy.

[0005] In order to solve the above technical problems, this application adopts the following technical solutions:

[0006] The technical solution of one aspect of the present application proposes an ablation catheter, comprising: a catheter body; a support skeleton, arranged at the distal end of the catheter body, the support skeleton has an equatorial position between its proximal end and its distal end, the support skeleton comprises a first frame and a second frame, the second frame is arranged at the distal end relative to the first frame, the proximal end of the first frame is connected to the distal end of the catheter body, the distal end of the first frame is connected to the proximal end of the second frame, and the first frame is configured as a conductive part in whole or in part; at least one ablation electrode, arranged on the second frame, at least one of the ablation electrodes is located between the equatorial position and the distal end of the second frame, the total area of ​​the ablation electrodes is smaller than the total area of ​​the conductive part, the ablation electrode cooperates with the conductive part to transmit ablation energy to the target tissue area for ablation; at least one mapping electrode, arranged on the second frame, at least one of the mapping electrodes is located at the equatorial position or between the equatorial position and the proximal end of the second frame, and the mapping electrode is used to detect electrophysiological signals of the target tissue area.

[0007] The technical solution of another aspect of the present application proposes an ablation system, comprising a pulse ablation device and the ablation catheter described in any of the above technical solutions, wherein the ablation catheter is connected to the pulse ablation device.

[0008] The ablation catheter proposed in the present application has a support frame comprising a first frame and a second frame, the first frame is entirely or partially configured as a conductive portion, and a mapping electrode and an ablation electrode are arranged on the second frame. Based on the design of the conductive portion, the ablation electrode and the mapping electrode, the ablation catheter has both mapping and ablation functions. In the case where the mapping and ablation functions are integrated into one, on the one hand, by arranging the first frame at the proximal end relative to the second frame, at least one ablation electrode is arranged between the equatorial position of the support frame and the distal end of the second frame, so that the positions of the conductive portion and the ablation electrode are relatively dispersed, thereby achieving a larger electric field between the conductive portion and the ablation electrode. The coverage range is beneficial to improving the ablation depth. In addition, the total area of ​​the ablation electrode is smaller than the total area of ​​the conductive part, so that the current density of the second frame will be relatively larger, and the ablation energy will be more concentrated on the second frame. In this way, ablation of the target tissue area using the second frame can obtain a deeper ablation depth and a better ablation effect; on the other hand, at least one mapping electrode of the ablation catheter is arranged at the equatorial position or between the equatorial position and the proximal end of the second frame, which ensures that even if the ablation catheter is in contact with the myocardial tissue, it can accurately map the electrophysiological signal, thereby improving the mapping effect and ensuring the mapping accuracy.

[0009] It should be understood that the foregoing general description and the following detailed description are exemplary only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The above and other objects, features and advantages of the present application will become more apparent by describing in detail exemplary embodiments thereof with reference to the attached drawings.

[0011] Figure 1 It is a schematic diagram of the structure of an ablation system provided in one embodiment of the present application.

[0012] Figure 2 This is a reference diagram of the usage status of an ablation catheter provided by an embodiment of the present application.

[0013] Figure 3 It is a schematic diagram of the structure of an ablation catheter provided in one embodiment of the present application.

[0014] Figure 4 It is a schematic diagram of the structure of an ablation catheter provided in one embodiment of the present application.

[0015] Figure 5 It is a schematic diagram of the cross-sectional structure of a catheter body of an ablation catheter provided in one embodiment of the present application.

[0016] Figure 6 It is a schematic diagram of the cross-sectional structure of a catheter body of an ablation catheter provided in one embodiment of the present application.

[0017] Figure 7It is a schematic structural diagram of a catheter body of an ablation catheter provided in one embodiment of the present application.

[0018] Figure 8 It is a schematic diagram of the structure of an ablation catheter in an expanded state provided by an embodiment of the present application.

[0019] Fig. 9 The indication is based on Figure 8 The deflated state of the ablation catheter is provided.

[0020] Fig.10 The indication is based on Figure 8 A further expanded state of the ablation catheter is provided.

[0021] Fig.11 The indication is based on Figure 8 A schematic diagram of the main structure of the ablation catheter is provided.

[0022] Fig.12 It is a schematic diagram of the main structure of an ablation catheter provided in one embodiment of the present application.

[0023] Fig.13 yes Fig.12 Schematic diagram of the enlarged structure of section A of the ablation catheter.

[0024] Fig.14 It is a schematic diagram of the main structure of an ablation catheter provided in one embodiment of the present application.

[0025] Fig.15 It is a schematic diagram of the structure of an ablation catheter provided in one embodiment of the present application.

[0026] Fig.16 yes Fig.15 Schematic diagram of the main structure of the ablation catheter.

[0027] Fig.17 It is a schematic diagram of the three-dimensional structure of a distal connector provided in one embodiment of the present application.

[0028] Fig.18 It is a schematic diagram of the three-dimensional structure of a distal connector provided in one embodiment of the present application.

[0029] Fig.19 It is a schematic diagram of the three-dimensional structure of the second proximal connecting piece provided in one embodiment of the present application.

[0030] Fig. 20 It is a schematic diagram of the three-dimensional structure of a first proximal connecting piece provided in one embodiment of the present application.

[0031] Fig.21 It is a schematic diagram of the structure of a catheter body provided by an embodiment of the present application.

[0032] The reference numerals are as follows:

[0033] 100, ablation catheter; 110, catheter body; 111, first proximal connector; 1111, first fixed tube; 1112, second fixed tube; 1113, annular wall; 112, second proximal connector; 1121, third fixed tube; 113, tube gap; 1141, bending section; 1142, support section; 1143, wire channel; 1144, braided mesh; 1145, hypotube; 1146, tube wall; 120, ablation component; 121, support frame; 1210-1, equatorial position; 1210-3, reference position; 1211, first frame; 1211-1, grid group; 1211-11, first main grid; 1211-12, second main grid; 1211-2, connection grid; 1211-21, first subgrid; 1211-22, second subgrid; 1211 -3, connecting rib; 1212, second frame; 1212-10, bearing rod; 1212-11, first bearing rod; 1212-12, second bearing rod; 1212-22, bending portion; 1212-3, insulating sleeve; 1212-4, distal plane; 122, ablation electrode; 123, mapping electrode; 130, traction tube; 132, distal connector; 1321, first connecting portion; 1321-11, positioning hole; 1321-21, axial hole; 1322, second connecting part; 13221, blocking rib; 13222, notch; 13223, receiving groove; 141, first reference electrode; 142, second reference electrode; 151, guide wire; 200, pulse ablation device; 300, terminal block; 400, multi-channel recorder; 500, three-dimensional mapping system; 600, conveyor. DETAILED DESCRIPTION

[0034] Although the present application can be easily embodied in different forms of embodiments, only some of the specific embodiments are shown in the drawings and described in detail in this specification. It should be understood that this description should be regarded as an exemplary illustration of the principles of the present application and is not intended to limit the present application to that described herein.

[0035] Thus, a feature indicated in this specification will be used to illustrate one of the features of an embodiment of the present application, rather than implying that each embodiment of the present application must have the described feature. In addition, it should be noted that this specification describes many features. Although some features can be combined together to illustrate possible system designs, these features can also be used in other combinations that are not explicitly described. Thus, unless otherwise stated, the described combinations are not intended to be limiting.

[0036] In the embodiments shown in the drawings, the indications of directions (such as up, down, left, right, front, back, etc.) used to explain the structure and movement of various elements of the present application are not absolute but relative. These descriptions are appropriate when these elements are in the positions shown in the drawings. If the descriptions of the positions of these elements change, the indications of these directions also change accordingly.

[0037] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, the features defined as "first" and "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0038] In the description of this application, it should be noted that, unless otherwise clearly specified and limited, the terms "install", "connect", "connect", and "set" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection, or it can be indirectly connected through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to specific circumstances.

[0039] Example embodiments will now be described more fully with reference to the accompanying drawings. However, example embodiments can be implemented in a variety of forms and should not be construed as limited to the examples set forth herein; rather, these example embodiments are provided so that the description of the present application will be more comprehensive and complete and the concepts of the example embodiments will be fully conveyed to those skilled in the art. The accompanying drawings are only schematic illustrations of the present application and are not necessarily drawn to scale. The same reference numerals in the figures represent the same or similar parts, and thus their repeated description will be omitted.

[0040] For ease of description, in the field of intracavitary interventional therapy, the proximal end refers to the end of the instrument that is close to the operator after the interventional therapy, and the distal end refers to the end of the instrument that is far away from the operator after the interventional therapy. "Proximal end" and "distal end" are non-restrictive descriptions of directions.

[0041] First embodiment

[0042] See also Figure 1 , Figure 1 It is a structural schematic diagram of an ablation system provided in this application.

[0043] In some embodiments, the ablation system may include a pulse ablation device and an ablation catheter 100, wherein the pulse ablation device may include a pulse ablator 200, a wiring board 300, a multichannel recorder 400, and a three-dimensional mapping system 500. The ablation catheter 100 is connected to the pulse ablator 200 via an ablation circuit and a mapping circuit, and the mapping circuit is also connected to the wiring board 300, the multichannel recorder 400, and the three-dimensional mapping system 500, respectively.

[0044] Among them, the pulse ablation device 200 may include a user interface, an energy generator, a data storage module and a controller. Among them, the user interface is used to indicate information such as various operations of the pulse ablation device for the convenience of the operator. The energy generator is used to emit pulse ablation energy. The data storage module stores executable instructions for cooperating with the controller to perform the various operations described in this embodiment. Under the three-dimensional mapping image, the operator can operate the pulse ablation device 200, control the ablation catheter 100 to reach the low-voltage area or focus of the patient's heart, and accurately ablate the focus, thereby blocking the conduction of abnormal electrical signals.

[0045] The three-dimensional mapping system 500 uses electric field modeling combined with electrocardiographic mapping to construct a heart model. Among them, electric field modeling is achieved through surface leads. Surface leads refer to electrodes attached to various parts of the body to form an orthogonal electric field and generate a surface electrocardiogram. After the ablation catheter 100 enters the orthogonal electric field, it forms a loop with the internal circuit of the three-dimensional mapping system 500 to form a three-dimensional model. In addition, the ablation catheter 100 can 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 500 can also combine computer tomography (CT) image data and digital subtraction angiography (DSA) image data to correct the heart model. The multichannel recorder 400 may include a storage unit, a processing unit and a display interface (not shown in the figure). The storage unit is used to receive cardiac electrical signals from the patient, the processing unit is used to analyze the ECG signals and generate corresponding images such as activation maps and voltage maps, and the display interface is used to display images such as activation maps and voltage maps to guide the operator to the location of the focal and low-voltage areas of the patient's heart.

[0046] In this embodiment, the heart model constructed only by surface leads and ablation catheter 100 contains a lot of noise. By inputting computed tomography image data and digital subtraction angiography image data and combining them with an algorithm, the coordinate values ​​of the image in the heart model can be corrected to form a more detailed heart model image, which is convenient for the operator to better control the ablation catheter 100 for ablation.

[0047] Please refer to Figure 2 and Figure 3 This embodiment proposes an ablation catheter 100, which mainly includes a catheter body 110 and an ablation component 120, and the ablation component 120 is arranged at the distal end of the catheter body 10. The ablation catheter 100 can be used for cardiac ablation. Specifically, the ablation catheter 100 can be delivered to the target tissue area by a conveyor 600 (specifically, such as a sheath) by percutaneous puncture for ablation isolation. For example, the target tissue area can be the mitral isthmus, the tricuspid isthmus, the top of the left atrium, the pulmonary vein, the left atrial appendage, or a triggering focus with typical atrial flutter and non-pulmonary vein origin (such as the superior vena cava, the coronary sinus ostium), etc.

[0048] It is understood that the target tissue area is not limited to being located in the heart, but may also be located on other body tissues, and this application does not limit this. The conveyor 600 includes but is not limited to components such as a sheath tube and a handle. It should be noted that the specific structure of the conveyor 600 can refer to the relevant technology in the field, and this application will not repeat it.

[0049] The ablation assembly 120 includes a support frame 121 and an electrode component disposed on the support frame 121 . The electrode component includes, for example, an ablation electrode 122 and a mapping electrode 123 . The proximal end of the support frame 121 is connected to the distal end of the catheter body 110 .

[0050] like Figure 4 As shown, the ablation catheter 100 can be bent in both directions. For example, the catheter body 110 of the ablation catheter 100 includes a bending section 1141 and a support section 1142, the support frame 121 is arranged at the distal end of the bending section 1141, and the proximal end of the bending section 1141 is connected to the distal end of the support section 1142. Through the bending deformation of the bending section 1141, the position of the ablation component 120 can be adjusted more flexibly.

[0051] The bending adjustment section 1141 is a soft section having an elastic modulus different from that of the supporting section 1142 .

[0052] The material of the bending adjustment section 1141 can be Pebax (also known as PEBA, Polyether Block Amide) or TPU (Thermoplastic Urethane). Further optionally, the hardness of the Pebax material of the bending adjustment section 1141 can be 35D or 40D, or the hardness of the TPU material of the bending adjustment section 1141 can be 70A-110A. The hardness of the Pebax material of the bending adjustment section 1141 can be further selected as 35D, or the hardness of the TPU material of the bending adjustment section 1141 can be further selected as 80A.

[0053] The material of the support section 1142 may be Pebax, and the hardness of the Pebax material of the support section 1142 may be 40D-72D. The hardness of the Pebax material of the support section 1142 may further be 72D.

[0054] Optionally, the bending section 1141 and the supporting section 1142 are connected together by hot-melt connection.

[0055] Optionally, in order to prevent the radial dimension of the support frame 121 from changing when the bending section 1141 is bent, so that the bending function and the diameter adjustment function are linked, the bending section 1141 can be in the form of a hypotube 1145, such as Figure 5 shown.

[0056] Optionally, the diameter of the catheter body 110 may be 8 F. The diameter of the catheter body 110 in this embodiment is only an example, and the diameter of the catheter body 110 may also be other sizes, which are not specifically limited here.

[0057] like Figure 6 As shown, the catheter body 110 has a single axial lumen or central lumen. Of course, in other embodiments, the catheter body 110 can be provided with multiple lumens therein as required to accommodate pull wires, lead wires, sensor wires and any other wires, cables and / or tubes that may be required in a specific application.

[0058] For example, the catheter body 110 includes a tube wall 1146 , and the tube wall 1146 of the catheter body 110 surrounds the axial tube cavity or the central tube cavity. The tube wall 1146 of the catheter body 110 can be made of TPU or Pebax material.

[0059] Optionally, a braided mesh 1144 is embedded in the tube wall 1146 of the catheter body 110. The braided mesh 1144 can be made of stainless steel wire, and the cross-sectional shape of the braided mesh 1144 can be circular or flat. The braided mesh 1144 can improve the support strength of the catheter body 110.

[0060] like Figure 7 As shown, at least one axially extending wire channel 1143 is provided in the tube wall 1146 of the catheter body 110 , and the wire 151 is axially inserted in the wire channel 1143 .

[0061] It is understandable that the wire channel 1143 can be opened in the tube wall 1146 of the bending section 1141 and the tube wall 1146 of the support section 1142. Since the bending section 1141 of the catheter body 110 can be bent by bending and deformation, in order to avoid the risk of the wire 151 in the wire channel 1143 of the bending section 1141 being broken, Figure 7As shown, the conductor 151 in the conductor channel 1143 corresponding to the bending section 1141 is spiral, wavy or zigzag-shaped, wherein the wavy, spiral or zigzag-shaped conductor 151 is beneficial for avoiding the phenomenon that the conductor 151 is broken during bending due to insufficient margin when the bending section 1141 is bent. At the same time, when the bending section 1141 is bent back, the wavy, spiral or zigzag-shaped conductor 151 can also alleviate the influence of the extrusion pressure on the conductor 151, thereby reducing the risk of breakage of the conductor 151.

[0062] See also Figure 8 , shows the structure of the support skeleton 121 in an expanded state. When the support skeleton 121 expands, the support skeleton 121 expands radially in a direction away from the axis of the catheter body 110. At this time, the two ends of the support skeleton 121 are gathered together and the middle part expands to form a cage shape as a whole. Further optionally, the support skeleton 121 is approximately spherical in shape when expanded. The fitting surface formed on the surface of the cage-shaped support skeleton 121 is easy to fit, and can be positioned on the target tissue area at any angle.

[0063] See also Fig. 9 , showing the Figure 8 The structure of the support frame 121 in the contracted state. When the support frame 121 contracts, the support frame 121 is radially gathered toward the axis direction of the catheter body 110. Specifically, Figure 8 Based on the structure of the support frame 121 shown in the figure, the support frame 121 can be contracted radially inward relative to the catheter body 110 under the action of external force, that is, the middle part of the support frame 121 is retracted toward the axial direction of the catheter body 110 to present the following Fig. 9 The support frame 121 is shown in a contracted state. In the contracted state, the support frame 121 will be straightened to a generally linear shape. In the contracted state of the support frame 121, the support frame 121 can be accommodated in a loading tube to facilitate delivery to the human body through a conveyor 600, wherein the conveyor 600 is sleeved outside the catheter body 110. When the support frame 121 reaches the target tissue area through the conveyor 600, the support frame 121 is released from the conveyor 600 and then unfolded into Figure 8 It is understandable that the expansion state of the support frame 121 can be formed by the support frame 121 naturally expanding when extending out of the conveyor 600, or it can be formed by the support frame 121 expanding under human control intervention after extending out of the conveyor 600. For example, for the ablation catheter 100 provided with the traction tube 130, the traction tube 130 described below can be driven by the handle to control the support frame 121 to switch from the contracted state to the expanded state.

[0064] See also Fig.10 , showing the Figure 8The structure of the support frame 121 in a further expanded state. Specifically, based on Figure 8 The structure of the support frame 121 shown in the figure makes the middle part of the support frame 121 further expand radially away from the axis of the catheter body 110. Figure 8 The expansion state shown is switched from Fig.10 The further expanded state is shown. The support skeleton 121 is roughly pumpkin-shaped in this further expanded state. Optionally, in this further expanded state, the distal end face of the support skeleton 121 is approximately a plane, that is, the distal plane 1212-4. Further optionally, at least one ablation electrode 122 is distributed in the distal plane 1212-4. In this way, when the support skeleton 121 is close to the target tissue area for ablation, the approximately planar structure is conducive to the support skeleton 121 being stably and vertically close to the lesion tissue, so that the ablation electrode 122 in the distal plane 1212-4 structure can better contact the lesion tissue, which is conducive to improving the ablation effect.

[0065] like Fig.11 As shown, an equatorial position 1210 - 1 is formed between the proximal end of the support frame 121 and the distal end of the support frame 121. Optionally, the equatorial position 1210 - 1 may specifically be the widest radial position of the support frame 121.

[0066] The support frame 121 includes a first frame 1211 and a second frame 1212 connected axially, the second frame 1212 is arranged at the distal end relative to the first frame 1211, the proximal end of the first frame 1211 is connected to the distal end of the catheter body 110, and the equatorial position 1210-1 is located between the proximal end of the second frame 1212 and the distal end of the second frame 1212. The first frame 1211 is entirely or partially configured as a conductive portion, and it can be understood that the conductive portion of the first frame 1211 can be used as an electrode due to its conductive properties.

[0067] The electrode component of the ablation assembly 120 specifically includes one or more ablation electrodes 122, which are arranged on the second frame 1212 and located between the equatorial position 1210-1 and the distal end of the second frame 1212 (i.e., the distal end of the supporting skeleton 121). At least one ablation electrode 122 cooperates with the conductive part to transmit ablation energy to the target tissue area for ablation.

[0068] It can be understood that during the pulse ablation process, positive and negative electrodes are used to form a pulse electric field to act on the target tissue to ablate the target tissue. In a specific example of the present application, the conductive part of the first frame 1211 and the ablation electrode 122 are used together to perform ablation. Specifically, the conductive part of the first frame 1211 of the ablation catheter 100 is electrically connected to an external energy generator (the external energy generator is, for example, the energy generator of the pulse ablation device 200) through a wire 151. The external energy generator can be set at the proximal end of the catheter body 110, and the conductive part of the first frame 1211 is electrically connected to one pole of the external energy generator through the wire 151, and at least one ablation electrode 122 is electrically connected to the other pole of the external energy generator. In this way, the conductive part of the first frame 1211 is used as one pole and the ablation electrode 122 is used as the other pole to transmit the ablation energy output by the external energy generator to the target tissue area, thereby realizing the ablation function. In this way, since the first frame 1211 is arranged at the proximal end relative to the second frame 1212, the ablation electrode 122 is arranged on the second frame 1212 and is located between the equatorial position 1210-1 and the distal end of the second frame 1212. In this way, the positions of the positive and negative poles are relatively dispersed, so that a larger electric field coverage range can be achieved between the positive and negative poles, thereby increasing the ablation depth.

[0069] In the case where multiple ablation electrodes 122 are arranged on the second frame 1212, optionally, some or all of the multiple ablation electrodes 122 are connected to one pole of an external energy generator, and the conductive part of the first frame 1211 is connected to the other pole of the external energy generator, thereby forming a pulsed electric field to transmit ablation energy to the target tissue area.

[0070] Of course, the embodiments of the present application are not limited to the above-mentioned examples. In other embodiments, the ablation catheter 100 may also be used in the following manners:

[0071] Connect the conductive part of the first frame 1211 to one pole of an external energy generator, and connect the other pole of the external energy generator to an electrode plate attached to the patient's body surface; or,

[0072] Connect at least one ablation electrode 122 among the multiple ablation electrodes 122 and the conductive part of the first frame 1211 to one pole of an external energy generator, and connect the other pole of the external energy generator to an electrode plate attached to the patient's body surface; or,

[0073] Connect at least one of the multiple ablation electrodes 122 to one pole of the external energy generator, and connect the remaining at least one ablation electrode 122 to the other pole of the external energy generator; or,

[0074] At least one of the multiple ablation electrodes 122 is connected to one pole of an external energy generator, and the other pole of the external energy generator is connected to an electrode plate attached to the patient's body surface.

[0075] Of course, it will be appreciated that, although high voltage pulses may be selected as the energy form delivered to multiple electrodes and / or a portion, other forms of ablation energy may additionally or alternatively be emitted, such as radio frequency energy or any other suitable form of energy.

[0076] Optionally, the external energy generator can be arranged on the handle at the proximal end of the catheter body 110, the proximal end of the conductive part of the first frame 1211 and the distal end of the wire 151 are connected together by welding, and the proximal end of the wire 151 is welded to the connector on the handle to connect to the external energy generator on the handle, and a wire channel 1143 is formed in the tube wall 1146 of the catheter body 110, and the wire 151 is axially penetrated through the wire channel 1143 in the tube wall 1146 of the catheter body 110.

[0077] Optionally, the total area of ​​the ablation electrode 122 is smaller than the total area of ​​the conductive part of the first frame 1211. In this way, the current density of the conductive part of the first frame 1211 is relatively small, while the current density of the ablation electrode 122 on the second frame 1212 is relatively large, so the energy will be more concentrated on the ablation electrode 122 of the second frame 1212, and the second frame 1212 is closer to the distal end than the first frame 1211, and is mainly used to abut against the target tissue area to ablate using the ablation electrode 122, so that a deeper ablation depth, higher ablation efficiency and better ablation effect can be obtained by ablation against the target tissue area with the second frame 1212 under the condition of more concentrated energy.

[0078] Optionally, the first frame 1211 is constructed as a conductive part as a whole. In this way, the structure of the first frame 1211 is simpler, and the processing and manufacturing will be more convenient. Moreover, the first frame 1211 is a conductive part as a whole, and a larger total area of ​​the conductive part can be obtained, thereby further reducing the current density of the conductive part, and correspondingly further improving the current density of the ablation electrode 122.

[0079] The electrode component of the ablation assembly 120 specifically further includes one or more mapping electrodes 123, which are arranged on the second frame 1212, at least one mapping electrode 123 is located at the equatorial position 1210-1 or between the equatorial position 1210-1 and the proximal end of the second frame 1212, and the mapping electrode 123 is used to detect electrophysiological signals in the target tissue area.

[0080] It can be understood that the ablation electrode 122 can be used for mapping in addition to ablation. Considering that when the side of the support frame 121 is against the myocardial tissue, since at least one ablation electrode 122 is arranged between the equatorial position 1210-1 of the support frame 121 and the distal end of the second frame 1212, the ablation electrode 122 may be in a suspended state at this time, resulting in unsatisfactory mapping effect. For this reason, the ablation catheter 100 is provided with at least one mapping electrode 123 arranged on the equatorial position 1210-1 or between the equatorial position 1210-1 and the proximal end of the second frame 1212, which ensures that even when the ablation catheter 100 is against the myocardial tissue, the myocardial electrical signal can be accurately mapped, thereby improving the mapping efficiency and effect and better ensuring the mapping accuracy.

[0081] In some embodiments, the first frame 1211 and the second frame 1212 together form a cage shape, that is, the first frame 1211 and the second frame 1212 together construct a support skeleton 121 whose main body is in a cage shape. Optionally, the axial length of the first frame 1211 is smaller than the axial length of the second frame 1212. In this way, the structural shape of the support skeleton 121 is simpler, and the first frame 1211 can be more reliably restricted to the side of the equatorial position 1210-1 away from the ablation electrode 122, thereby more reliably ensuring the ablation efficiency and ablation depth.

[0082] In some embodiments, Fig.11 As shown, the first frame 1211 is a grid structure in which multiple pillars are connected end to end, the proximal end of the grid structure is connected to the distal end of the catheter body 110, and the distal end of the grid structure is connected to the proximal end of the second frame 1212. Accordingly, one or more of the multiple pillars can be set as a conductive part, and the total area of ​​the conductive part is correspondingly understood as the sum of the areas of one or more pillars used as the conductive part. Among them, by setting the first frame 1211 to include a grid structure, a larger total area of ​​the conductive part can be obtained based on the first frame 1211 of a certain volume and / or weight, thereby achieving an increase in the ablation depth. And it can be understood that by using the first frame 1211 including a grid structure, the second frame 1212 and the ablation electrode 122 on the second frame 1212 can be more stably supported, and the support skeleton 121 can have the ability to better maintain its cage shape in the expanded state, so that the ablation electrode 122 on the second frame 1212 can be more accurately and stably attached to the target tissue, thereby improving the ablation effect. In addition, the first frame 1211 has a grid structure design, which can make the first frame 1211 have a better folding and shrinking effect. In this way, when the support skeleton 121 shrinks, the grid structure of the first frame 1211 is compactly folded to enhance the volume shrinkage effect, thereby improving the sheathing effect of the support skeleton 121 and reducing the risk of damage to the conveyor 600 by the support skeleton 121.

[0083] For example, the grid structure of the first frame 1211 specifically includes a plurality of grid groups 1211-1, which are arranged circumferentially around the central axis of the support frame 121, and the distal end of each grid group 1211-1 is connected to the proximal end of the second frame 1212, and the proximal end of each grid group 1211-1 is connected to the distal end of the catheter body 110, and two adjacent grid groups 1211-1 are connected to each other in the circumferential direction of the support frame 121. The structure in which the plurality of grid groups 1211-1 are arranged around the central axis facilitates the first frame 1211 to contract and expand more efficiently, and the first frame 1211 can support the second frame 1212 more evenly and stably in the expanded state.

[0084] The grid structure also includes a plurality of connecting grids 1211-2, and two adjacent grid groups 1211-1 are connected by at least one connecting grid 1211-2 in the circumferential direction of the support frame 121. By connecting two adjacent grid groups 1211-1 through the connecting grid 1211-2, the support stability of the grid group 1211-1 to the second frame 1212 can be further improved.

[0085] Each grid group 1211-1 includes at least one main grid, at least one connecting grid 1211-2 is arranged between two adjacent grid groups 1211-1, at least one connecting grid 1211-2 reuses one side with each main grid in the two adjacent grid groups 1211-1, and the outlines of the main grid and the connecting grid 1211-2 are both polygonal.

[0086] Each grid group 1211-1 includes a first main grid 1211-11 and a second main grid 1211-12, the first main grid 1211-11 and the second main grid 1211-12 share a grid node, and the second main grids 1211-12 of two adjacent grid groups 1211-1 reuse one side; the distal end of the first main grid 1211-11 is correspondingly connected to the proximal end of the second frame 1212, the second main grid 1211-12 is a polygon opened toward the catheter body 110, and the proximal end of the second main grid 1211-12 is connected to the distal end of the catheter body 110; a connecting grid 1211-2 is provided between two adjacent grid groups 1211-1, and the connecting grid 1211-2 reuses one side with each first main grid 1211-11 and each second main grid 1211-12 in the two adjacent grid groups 1211-1.

[0087] Among them, the setting of the grid group 1211-1 structure can further enhance the supporting stability of the first frame 1211 to the second frame 1212 by increasing the surface area of ​​the first frame 1211 through the structure that the first main grid 1211-11 and the second main grid 1211-12 share a vertex and the second main grids 1211-12 of two adjacent grid groups 1211-1 reuse one side. In this way, the ablation electrode 122 on the second frame 1212 can be more stably attached to the target tissue area, thereby enhancing the ablation effect.

[0088] Optionally, the first main grid 1211-11 is configured in a rhombus shape, and the second main grid 1211-12 is configured in a rhombus-like structure. This has the advantages of simple structure and easier processing and manufacturing, and the rhombus-shaped or rhombus-like grid structure can be folded more regularly when contracted, thereby improving the radial sheathing effect of the support frame 121 and reducing the risk of damage to the conveyor 600 by the support frame 121.

[0089] In more detail, the second main grid 1211-12 is configured to be a rhombus with an opening at the proximal end, that is, the main body of the second main grid 1211-12 is roughly rhombus-shaped, and the two edges of the proximal end of the second main grid 1211-12 are opened to form an opening. In this way, the second main grid 1211-12 can be neatly folded during the sheathing of the support skeleton 121, and the proximal end of the second main grid 1211-12 can be more conveniently connected to the catheter body 110. For example, the two edges of the proximal end of the second main grid 1211-12 extend to form connecting ribs 1211-3, which are connected to the catheter body 110 using the connecting ribs 1211-3, making it easier to ensure the connection strength and assemblability.

[0090] The connection grid 1211-2 includes a first sub-grid 1211-21 and a second sub-grid 1211-22. The first sub-grid 1211-21 and the second sub-grid 1211-22 reuse one side. The first sub-grid 1211-21 reuses one side with the first main grid 1211-11 and the second main grid 1211-12 in one of the adjacent grid groups, and the second sub-grid 1211-22 reuses one side with the first main grid 1211-11 and the second main grid 1211-12 in another adjacent grid group.

[0091] For example, the connection grid 1211-2 includes a first sub-grid 1211-21 and a second sub-grid 1211-22. The first sub-grid 1211-21 and the second sub-grid 1211-22 share one side. The first sub-grid 1211-21 and the first main grid 1211-11 and the second main grid 1211-12 in one of the adjacent grid groups 1211-1 share one side respectively. The second sub-grid 1211-22 and the first main grid 1211-11 and the second main grid 1211-12 in another adjacent grid group 1211-1 share one side respectively. The first subgrid 1211-21 reuses one side with the first main grid 1211-11 and the second main grid 1211-12 in the grid group 1211-1 on the left, respectively; the second subgrid 1211-22 reuses one side with the first main grid 1211-11 and the second main grid 1211-12 in the grid group 1211-1 on the right, respectively; the connecting grid 1211-2 is smoothly connected with the first main grids 1211-11 on both sides to form a roughly V-shaped structure. In this way, through the closing and opening of the V-shaped structure, it can better adapt to the switching of the contraction and expansion of the support frame 121, so that the connecting grid 1211-2 can be folded more regularly, thereby improving the radial sheathing effect of the support frame 121 and reducing the risk of damage to the conveyor 600 by the support frame 121.

[0092] Optionally, the first subgrid 1211-21 and the second subgrid 1211-22 are both configured in a rhombus shape, which has the advantages of simple structure and easier processing and manufacturing, and the rhombus-shaped grid structure can be folded more regularly when contracted, thereby improving the radial sheathing effect of the support frame 121 and reducing the risk of damage to the conveyor 600 by the support frame 121.

[0093] Optionally, the first frame 1211 includes 24 grids, and optionally, all grids are rhombuses. In this way, while ensuring the area of ​​the first frame 1211, the first frame 1211 has a certain grid density, so as to better take into account the support stability of the first frame 1211 to the second frame 1212. Of course, the embodiments of the present application are not limited to this. It can be understood that this scheme does not specifically limit the shape and number of grids. The shape of the grid can also be other polygons or a combination of different polygons, such as pentagons, hexagons, etc., or a combination of triangles and rhombuses, a combination of triangles and pentagons, etc. The number of grids can also be set according to actual needs, and is not limited to 24.

[0094] Optionally, the first frame 1211 and the second frame 1212 are an integrated structure. For example, the support skeleton 121 is made of a metal tube by cutting and heat setting, that is, the distal end of the first main grid 1211-11 and the proximal end of the second frame 1212 are integrated. Optionally, the support skeleton 121 is made of a nickel-titanium alloy tube by cutting and heat setting. Or, for example, the first frame 1211 and the second frame 1212 of the support skeleton 121 are integrally printed by metal materials through 3D technology. Or, for example, the first frame 1211 and the second frame 1212 of the support skeleton 121 can be woven from wire.

[0095] Of course, the embodiments of the present application are not limited thereto, and in other embodiments, the first frame 1211 and the second frame 1212 may also be separate components. For example, the first frame 1211 of the support frame 121 may be made by cutting and heat-setting a metal pipe, or by metal 3D printing, or by weaving a wire, and the distal end of the first main grid 1211-11 of the first frame 1211 and the proximal end of the second frame 1212 may be connected by welding, clamping, bonding, hot melting, threaded connection, sealing connection, or a combination of one or more methods.

[0096] Combination Fig.11 It can be understood that the second frame 1212 includes a plurality of bearing rods 1212-10 (the plurality of bearing rods 1212-10 can be specifically understood by referring to the first bearing rod 1212-11 and the second bearing rod 1212-12 shown in the accompanying drawings), the plurality of bearing rods 1212-10 are arranged at intervals around the central axis of the supporting skeleton 121, the distal ends of the plurality of bearing rods 1212-10 are close to the central axis of the supporting skeleton 121 and are fixed to each other, the proximal ends of the plurality of bearing rods 1212-10 are connected to the distal end of the first frame 1211, and at least one ablation electrode 122 and at least one mapping electrode 123 are arranged on the bearing rods 1212-10.

[0097] Optionally, the number of the bearing rods 1212-10 used in the second frame 1212 may be three, four, five, six, seven, eight, nine or any other suitable number. Optionally, the number of the bearing rods 1212-10 is an even number. Optionally, in this embodiment, the number of the bearing rods 1212-10 is six.

[0098] Furthermore, a plurality of ablation electrodes 122 are provided, and at least one ablation electrode 122 is provided on each support rod 1212 - 10 . The ablation electrode 122 is located between the position on the support rod 1212 - 10 corresponding to the equatorial position 1210 - 1 and the distal end of the support rod 1212 - 10 .

[0099] In some specific embodiments, a plurality of ablation electrodes 122 are arranged on each supporting rod 1212 - 10 along its axial direction; the plurality of ablation electrodes 122 form a plurality of rings on the circumference of the second frame 1212 , and the plane of each ring is perpendicular to the central axis of the supporting frame 121 .

[0100] Schematically, two ablation electrodes 122 are provided on each supporting rod 1212 - 10 of this embodiment. The ablation electrodes 122 are ring electrodes. In the multiple supporting rods 1212 - 10 , the ablation electrodes 122 correspond one to one along the axial direction to form two rings on the circumference of the second frame 1212 .

[0101] The material of the ablation electrode 122 can be platinum, iridium, gold, silver, etc., which are medical metals that can be used for interventional treatment. It can be understood that the present embodiment does not limit the shape of the ablation electrode 122, and the ablation electrode 122 can also be a sheet electrode, a point electrode, or a spherical electrode, etc. All of the above ablation electrodes 122 can participate in the mapping of ECG signals.

[0102] Each ablation electrode 122 on the bearing rod 1212-10 is connected to the external energy generator through a wire. Specifically, a wire with an insulating sleeve is welded to the inner wall of each ablation electrode 122, and one end of the wire is welded to the connector on the handle to connect to the external energy generator, and is connected to the inner wall of the ablation electrode 122 via the catheter body 110. In addition to being connected to the wire by welding, the ablation electrode 122 can also be connected by other special processes. The wire connected to the ablation electrode 122 can be an enameled wire, which has insulation properties and can withstand a voltage greater than or equal to 500V. After the ablation electrode 122 is connected to the external energy generator through a wire, the external energy generator can provide an electric pulse to the ablation electrode 122 to perform an electroporation operation. Optionally, the external energy generator can deliver a plurality of different pulses of various waveforms or shapes to the ablation electrode 122 to achieve electroporation ablation of the lesion tissue. The energy pulse train received by the ablation electrode 122 includes a single-phase pulse or a bi-phase pulse. The ablation electrode 122 can be configured with single-phase or bi-phase pulses with different parameters such as voltage, pulse width, repetition frequency, duty cycle and number of pulses.

[0103] In some specific embodiments, the plurality of bearing bars 1212 - 10 include a plurality of first bearing bars 1212 - 11 and a plurality of second bearing bars 1212 - 12 , and the plurality of first bearing bars 1212 - 11 and the plurality of second bearing bars 1212 - 12 are alternately arranged around the central axis of the supporting frame 121 .

[0104] At least one mapping electrode 123 is disposed on the first bearing rod 1212-11 and is located at a position on the first bearing rod 1212-11 corresponding to the equatorial position 1210-1, or is located between a position on the first bearing rod 1212-11 corresponding to the equatorial position 1210-1 and a proximal end of the first bearing rod 1212-11, or,

[0105] At least one mapping electrode 123 is disposed on the second supporting rod 1212-12 and is located at a position on the second supporting rod 1212-12 corresponding to the equatorial position 1210-1, or is located between a position on the second supporting rod 1212-12 corresponding to the equatorial position 1210-1 and the proximal end of the second supporting rod 1212-12.

[0106] In the present embodiment, the ablation catheter 100 specifically includes three mapping electrodes 123, which are used to detect electrocardiogram signals. The three mapping electrodes 123 are respectively arranged on three non-adjacent bearing rods 1212-10. In other words, the plurality of bearing rods 1212-10 are divided into a plurality of first bearing rods 1212-11 and a plurality of second bearing rods 1212-12 that are alternately arranged circumferentially. For example, six bearing rods 1212-10 are divided into three first bearing rods 1212-11 and three second bearing rods 1212-12. The first bearing rods 1212-11 and the second bearing rods 1212-12 are alternately arranged circumferentially. The first bearing rods 1212-11 are provided with a plurality of ablation electrodes 122 (such as The second supporting rod 1212-12 is provided with a plurality of ablation electrodes 122 (such as two ablation electrodes 122) at a position between the equatorial position 1210-1 and the distal end of the supporting frame 121, and the mapping electrode 123 is provided at a position of the first supporting rod 1212-11 corresponding to the equatorial position 1210-1 or at a position between the first supporting rod 1212-11 corresponding to the equatorial position 1210-1 and the proximal end of the first supporting rod 1212-11, while the second supporting rod 1212-12 is not provided with the mapping electrode 123.

[0107] Compared with the solution in which each supporting rod 1212-10 is provided with a marking electrode 123, the present embodiment provides marking electrodes 123 on non-adjacent supporting rods 1212-10, which can reduce the number of marking electrodes 123, thereby correspondingly reducing the number of wires, which is more conducive to process assembly. Secondly, by providing marking electrodes 123 on non-adjacent supporting rods 1212-10, the number of marking electrodes 123 can already meet the marking requirements.

[0108] Each mapping electrode 123 is located at the equatorial position 1210-1 or at a side of the equatorial position 1210-1 close to the support frame 121. Optionally, the mapping electrode 123 is located at the proximal end of the support rod 1212-10 or at a position close to the proximal end of the support rod 1212-10. In this way, when the ablation catheter 100 is attached to the myocardial tissue, the electrocardiogram signal of the myocardium can be accurately mapped.

[0109] Optionally, the mapping electrode 123 is a ring electrode. The present embodiment does not limit the shape of the mapping electrode 123. The mapping electrode 123 can also be a sheet electrode, a point electrode, or a spherical electrode. The material of the mapping electrode 123 can be platinum, iridium, gold, silver, or other medical metals that can be used for interventional treatment. Optionally, like the ablation electrode 122, the mapping electrode 123 is sleeved on the outside of the insulating sleeve on the outside of the rod body of the bearing rod 1212-10.

[0110] In some other specific embodiments, a plurality of mapping electrodes 123 are provided, and at least one mapping electrode 123 is provided on each first supporting rod 1212 - 11 or each second supporting rod 1212 - 12 .

[0111] Combination Fig.12 and Fig.13 It can be understood that each bearing rod 1212-10 includes a rod body and an insulating sleeve 1212-3 sleeved on the rod body, at least one ablation electrode 122 and at least one mapping electrode 123 are arranged on the insulating sleeve 1212-3, wherein the distal end of the rod body is exposed relative to the distal end of the insulating sleeve 1212-3, and forms a bent portion 1212-22, the bent portion 1212-22 is fixed in the traction tube 130 described below, and the farthest end of the insulating sleeve 1212-3 is connected to the farthest end of the traction tube 130. The far end of each insulating sleeve 1212-3 extends to the vicinity of the bent portion 1212-22 of the rod body, but does not exceed the bent portion 1212-22. In this way, the insulating sleeve 1212-3 will not extend into the traction tube 130, thereby avoiding the problem of the distal size of the support skeleton 121 being too large due to the insulating sleeve 1212-3 extending into the traction tube 130, and correspondingly achieving a reduction in the distal size of the support skeleton 121, which can facilitate the sheathing of the support skeleton 121 and avoid the ring electrode on the support skeleton 121 scraping the inner wall of the delivery channel of the conveyor 600, thereby further avoiding the risk of embolism.

[0112] Optionally, the insulating sleeve 1212-3 is made of a PEBAX tube or other polymer insulating materials, and the insulating sleeve 1212-3 may be one layer, two layers, or multiple layers, which is not limited here. The insulating sleeve of this embodiment is one layer.

[0113] Optionally, the cross-sectional shape of the rod body may be circular, semicircular, drum-shaped or other shapes, which are not limited here.

[0114] Optionally, the rod body is made of nickel-titanium wire, so that the rod body has excellent elastic properties and strength, so that it can be well attached to the target tissue area. The surface of the nickel-titanium wire is vacuum-coated so that its surface is covered with a layer of insulating coating. It can be understood that the rod body can also be made of other materials, such as stainless steel or polymer materials. The ablation electrode 122 is sleeved on the insulating sleeve 1212-3 to ensure the insulation between the ablation electrode 122 and the rod body. The inner surface of each ablation electrode 122 is connected to the connector on the handle through a wire from the surface of the insulating sleeve 1212-3 through the rod body along the gradient nickel-titanium wire through the catheter body 110.

[0115] Optionally, the rod body and the first frame 1211 are both made of nickel-titanium. In this way, the support frame 121 adopts a double-layer nickel-titanium grid structure of the first frame 1211 and the second frame 1212. The first frame 1211 is a dense grid structure with good support performance, and the second frame 1212 is a multi-rod structure with better flexibility and easier to stick to. The shape memory property of the nickel-titanium frame enables the support frame 121 to have good sheathing performance.

[0116] Optionally, the electrode width of the mapping electrode 123 is less than or equal to the electrode width of the ablation electrode 122 , which can prevent the potential signal collected by the mapping electrode 123 from becoming a composite signal, and is more conducive to the operator's judgment.

[0117] Optionally, a wire is connected to the inner side of the mapping electrode 123, and the wire of the mapping electrode 123 and the wire of the ablation electrode 122 can share a wire path. Of course, it is understandable that the wire of the mapping electrode 123 can also be set in a wire path different from that of the ablation electrode 122.

[0118] like Fig.11 As shown, the lengths of the first bearing rod 1212-11 and the second bearing rod 1212-12 are equal. Specifically, the proximal ends of the first bearing rod 1212-11 and the proximal ends of the second bearing rod 1212-12 are both approximately located at the reference position 1210-3, and accordingly, the distal vertices of the first main grid 1211-11 in the first frame 1211 are both approximately located at the reference position 1210-3 and are respectively connected to the proximal ends of the first bearing rod 1212-11 and the proximal ends of the second bearing rod 1212-12.

[0119] Please continue reading Figure 8 The ablation catheter 100 further includes a traction tube 130. The traction tube 130 extends from the distal end of the catheter body 110, and the distal end of the traction tube 130 is connected to the distal end of the support frame 121, and the movement of the traction tube 130 drives the support frame 121 to expand and contract radially.

[0120] More specifically, the traction tube 130 can be movably inserted into the catheter body 110 and extend out of the distal end of the catheter body 110 , and the distal ends of multiple bearing rods 1212 - 10 (such as the first bearing rod 1212 - 11 and the second bearing rod 1212 - 12) converge at the distal end of the traction tube 130 .

[0121] The traction tube 130 can move relative to the catheter body 110 along the central axis of the traction tube 130. During the movement of the traction tube 130 from the distal end of the catheter body 110 to the proximal end of the catheter body 110, the axial dimension of the support skeleton 121 becomes smaller and the radial dimension becomes larger; during the movement of the traction tube 130 from the proximal end of the catheter body 110 to the distal end of the catheter body 110, the axial dimension of the support skeleton 121 becomes larger and the radial dimension becomes smaller.

[0122] Therefore, the outer diameter of the support skeleton 121 can be flexibly adjusted through the traction tube 130, so that the support skeleton 121 can adapt to blood vessels or other body tissues of different diameters, and can ablate the target ablation area under any appropriate outer diameter condition, thereby improving the adaptability to the anatomical morphology of different target ablation areas, facilitating the operation of the ablation device, and achieving a better ablation effect.

[0123] Optionally, the traction tube 130 may be a steel cable, a flexible polyimide (PI) tube, a fluoropolyethylene tube, a stainless steel tube, or other polymer materials.

[0124] Optionally, a magnetic sensor for positioning is disposed in the traction tube 130 .

[0125] Optionally, the ablation catheter 100 further includes a reference electrode, which is disposed on the catheter body 110 and / or the traction tube 130 , and is used for electrocardiogram signal mapping to obtain a reference potential.

[0126] For example, Figure 8 As shown, the reference electrode specifically includes a first reference electrode 141 disposed on the traction tube 130. Specifically, the first reference electrode 141 is disposed on the tube wall of the traction tube 130. The connection methods of the first reference electrode 141 and the tube wall of the traction tube 130 include, but are not limited to, welding, clamping, bonding, integral molding, etc. An opening is provided at the position where the first reference electrode 141 is connected to the tube wall of the traction tube 130. A wire with an insulating sleeve is welded to the inner wall of the first reference electrode 141. One end of the wire is welded to the connector on the handle and is connected to the inner wall of the first reference electrode 141 disposed on the traction tube 130 through the opening via the inner cavity of the traction tube 130. The first reference electrode 141 can collect near-field unipolar electrograms, filter out some noise, improve the signal-to-noise ratio, and make the collected electrocardiogram more three-dimensional.

[0127] In some embodiments, see Figure 8 The reference electrode includes a second reference electrode 142 disposed on the catheter body 110. Specifically, the second reference electrode 142 is disposed on the bending section 1141 of the catheter body 110. The second reference electrode 142 is provided with a single or multiple second reference electrodes 142. The single or multiple second reference electrodes 142 are spaced apart along the axial direction of the catheter body 110. In this embodiment, the second reference electrode 142 is 2 annular electrodes. It can be understood that this embodiment does not specifically limit the shape and quantity of the second reference electrode 142. The second reference electrode 142 can be made of metal materials such as platinum, iridium, gold, and silver. The connection method with the catheter body 110 includes but is not limited to welding, clamping, bonding, integrated molding, and the like.

[0128] Optionally, the length of the second reference electrode 142 ranges from 0.5 mm to 2 mm, and further optionally 1.2 mm. An opening is provided at the position where each second reference electrode 142 is connected to the catheter body 110, and a wire with an insulating sleeve is welded to the inner wall of each second reference electrode 142, one end of the wire is welded to the connector on the handle, and is connected to the inner wall of the second reference electrode 142 through the inner cavity of the catheter body 110 through the opening.

[0129] The first function of the second reference electrode 142 on the catheter body 110 is to act as a reference electrode. Secondly, it can be used as a positioning electrode of the three-dimensional mapping system 500, and is used to display the body of the catheter body 110 during the three-dimensional modeling process. In addition, the second reference electrode 142 can also be used as a negative electrode. The negative electrode discharge area increases within a certain range, which is conducive to increasing the ablation depth. In some embodiments, the wire of the second reference electrode 142 can be set in a wavy line, spiral, or broken line shape to prevent the wire of the second reference electrode 142 from being tightened and broken when the catheter body 110 is bent.

[0130] In general, the support skeleton 121 of the present embodiment is an overall cage-like structure. When the multiple ablation electrodes 122 on the first frame 1211 and the second frame 1212 of the support skeleton 121 discharge, they can be regarded as local point ablation. By connecting points one by one, the needs of surgical operations such as linear ablation of the tricuspid isthmus, left atrial top line, left atrial bottom line, and mitral isthmus line in the treatment of arrhythmias can be achieved.

[0131] The following is a description of the surgical procedure using the ablation catheter 100 of this embodiment:

[0132] Through femoral vein puncture, the conveyor 600 is sent to the left atrium. The conveyor 600 is bent and the ablation catheter 100 is released in the left atrium to perform ablation and line ablation of anatomical parts (such as the top line of the left atrium, the line of the mitral valve isthmus, the posterior wall of the left atrium, etc.). The abnormal lesion area can also be found through three-dimensional mapping, and focal pulse ablation and removal of abnormal excitation points can be performed. At this time, a pulse ablation electric field is formed between the first frame 1211 of the support frame 121 and the multiple ablation electrodes 122 on the second frame 1212 of the support frame 121, causing necrosis of the tissue in the lesion area. After completion, the conveyor 600 and the ablation catheter 100 are withdrawn from the left atrium and reach the right atrium to perform line ablation and isolation of the tricuspid valve isthmus. At this time, a pulse ablation electric field is formed between the first frame 1211 of the support frame 121 and the multiple ablation electrodes 122 on the second frame 1212 of the support frame 121 for ablation, and ablation and electrical isolation of supraventricular tachycardia can also be performed.

[0133] Here is an explanation of three-dimensional mapping: the ablation electrode 122 can be used not only for ablation, but also for mapping, that is, the ablation electrode 122 and the mapping electrode 123 jointly map the cardiac electrical signals. The ablation electrode 122 and the mapping electrode 123 are connected to the connector on the handle through a wire, and then connected to the external energy generator, the multichannel recorder 400 and the three-dimensional mapping system 500 through a cable. These three connections are synchronous, and the signal connected to the external energy generator can also be connected to other systems through the signal output port for use. The electrocardiogram connected to the three-dimensional mapping system 500 is processed by a computer to generate an excitation map or a voltage map or other map. Each mapping electrode 123 is a single channel. When the cardiac electrical signal passes through the mapping electrode 123, an electrocardiogram is generated, which is called a unipolar electrogram (denoted as A). The other mapping electrode 123 generates a unipolar electrogram B. The actual use is a bipolar electrogram, and AB is used to generate an electrocardiogram C. When connected to the three-dimensional mapping system, the three-dimensional mapping system will form an electrical circuit with each mapping electrode 123, measure the field strength of each circuit, and locate and trace the mapping electrode 123 in contact with the inner wall of the heart through the electric field gradient equation and the distance relationship with the reference electrode. By moving the ablation catheter 100, the entire heart model can be constructed, and the heart electrical signals can be recorded when attached, thus forming a heart model with an excitation signal.

[0134] During the pulse ablation process, the positive and negative electrodes form a pulse electric field to act on the target tissue. In this embodiment, the first frame 1211 with a conductive grid structure and the ablation electrode 122 are used to perform ablation. The first frame 1211 serves as one pole and the ablation electrode 122 serves as the other pole. The first frame 1211 is located in the lower hemisphere below the equatorial position 1210-1, the second frame 1212 is mainly located in the upper hemisphere, and the ablation electrode 122 is arranged above the equatorial position 1210-1 of the supporting frame 121. The advantage of this electrode arrangement is that, on the one hand, the positive and negative pole positions are relatively dispersed, which can make A larger electric field coverage range can be achieved between the positive and negative electrodes, thereby increasing the ablation damage depth. On the other hand, compared with the electrode area of ​​the ablation electrode 122 on the second frame 1212, the electrode area of ​​the first frame 1211 in the form of a grid structure is larger, so the current density of the first frame 1211 is smaller, and the current density of the ablation electrode 122 on the second frame 1212 is larger, so the energy will be more concentrated in the second frame 1212, and the second frame 1212 is mainly attached to the tissue for ablation. Therefore, when the energy is more concentrated, the ablation depth of ablation using the second frame 1212 attached to the tissue will be deeper. In addition, in addition to being used for ablation, the ablation electrode 122 can also participate in mapping. At the same time, considering that when the spherical electrode holder is against the myocardial tissue, the ablation electrode 122 may be in a suspended state, resulting in an unsatisfactory mapping effect, further, a special mapping electrode 123 is further provided at the equatorial position 1210-1 close to the spherical electrode holder or below the equatorial position 1210-1 to ensure that even when the catheter is against the myocardial tissue, the myocardial electrocardiogram signal can be accurately mapped.

[0135] In summary, the ablation catheter 100 provided in the present embodiment, based on the design of the first frame 1211, the ablation electrode 122 and the mapping electrode 123, enables the ablation catheter 100 to have both mapping and ablation functions. When the mapping and ablation functions are integrated into one, by arranging the first frame 1211 in the form of a dense grid in the lower hemisphere of the bracket, the ablation electrode 122 in the upper hemisphere of the bracket and above the equatorial position 1210-1, and the mapping electrode 123 at the equatorial position 1210-1 of the bracket or below the equatorial position 1210-1, the ablation catheter 100 of the present embodiment can not only ensure the ablation effect and increase the ablation depth, but also improve the mapping efficiency and effect and ensure the mapping accuracy.

[0136] In addition, the ablation catheter 100 of this embodiment can also perform zoned ablation, that is, select the ablation electrode 122 that is in good contact with the target tissue area among multiple ablation electrodes 122 for discharge, avoiding the waste of energy caused by the discharge of the ablation electrode 122 that is not in contact, and the discharge into the air of the ablation electrode 122 that is not in contact may also increase the stimulation to the patient, and the ablation catheter 100 of this application can adopt the method of zoned discharge to achieve precise zoned ablation, and local ablation in different regions can avoid damage to tissues that are not intended to be ablated. The ablation energy can act on the tissue that needs to be ablated in a targeted manner, increase the utilization rate of the ablation energy, reduce the dissipation of the ablation energy in the blood, and reduce unnecessary bubbles generated by electrolyzing the blood.

[0137] Second embodiment

[0138] See also Fig.14 , illustrates an ablation catheter 100 of a second embodiment. The ablation catheter 100 of the second embodiment has substantially the same structure as the ablation catheter 100 of the first embodiment. The ablation catheter 100 of the second embodiment also includes a catheter body 110 and an ablation component 120. The ablation component 120 includes a support frame 121, at least one ablation electrode 122, and at least one mapping electrode 123.

[0139] The catheter body 110 , the ablation electrode 122 , and the mapping electrode 123 of the second embodiment are the same as those of the first embodiment, and are not described in detail herein.

[0140] The difference between the ablation catheter 100 of the second embodiment and the ablation catheter 100 of the first embodiment is that the end of the first frame 1211 of the support skeleton 121 facing the second frame 1212 includes a first connection end H1 and a second connection end H2, and the first connection end H1 is closer to the proximal end of the first frame 1211 than the second connection end H2. Accordingly, when at least one mapping electrode 123 is provided on the first bearing rod 1212-11, the length of the first bearing rod 1212-11 is longer than the length of the second bearing rod 1212-12, and the proximal end of the first bearing rod 1212-11 is connected to the first connection end H1, and the proximal end of the second bearing rod 1212-12 is connected to the second connection end H2.

[0141] Specifically, since the ablation electrode 122 is arranged above the equatorial position 1210-1 of the cage-shaped supporting frame 121, and the mapping electrode 123 is arranged at the equatorial position 1210-1 of the cage-shaped supporting frame 121 or at a position below the equatorial position 1210-1, the axial length of the first frame 1211 is smaller than the axial length of the second frame 1212. In this way, the ablation depth and the area ratio K of the surface area S1 of the first frame 1211 and the surface area S2 of the ablation electrode 122 are close to a linear relationship, that is, if a larger ablation depth is to be achieved, the area ratio K can be increased, K=S1 / S2, and the axial length of the first frame 1211 becomes smaller, which means that the surface area S1 of the first frame 1211 is reduced, the area ratio K is reduced, and the ablation depth is reduced. Therefore, in order to avoid the influence of the ablation depth due to the setting of the mapping electrode 123, the length of the supporting rod 1212-10 can be set to unequal length. That is, the length of the bearing rod 1212-10 (i.e., the first bearing rod 1212-11) provided with the marking electrode 123 is greater than the length of the bearing rod 1212-10 (i.e., the second bearing rod 1212-12) not provided with the marking electrode 123. In this way, the reduction in area of ​​the first main grid 1211-11 and the second sub-grid 1211-22 corresponding to the long bearing rod 1212-10 (i.e., the first bearing rod 1212-11) and the increase in area of ​​the first main grid 1211-11 and the first sub-grid 1211-21 corresponding to the short bearing rod 1212-10 (i.e., the second bearing rod 1212-12) can offset each other, so that the surface area S1 of the first frame 1211 will not be reduced due to the setting of the marking electrode 123. In this way, the marking electrode 123 can be set to improve the marking effect, and the ablation effect can be ensured not to be affected by the setting of the marking electrode 123.

[0142] Of course, the embodiments of the present application are not limited to this. In other embodiments, when at least one marking electrode 123 is arranged on the second bearing rod 1212-12, the length of the second bearing rod 1212-12 can also be set to be longer than the length of the first bearing rod 1212-11, and the proximal end of the second bearing rod 1212-12 is connected to the first connecting end H1, and the proximal end of the first bearing rod 1212-11 is connected to the second connecting end H2.

[0143] Third embodiment

[0144] refer to Figures 15 to 17 The ablation catheter 100 of the third embodiment has substantially the same structure as the ablation catheter 100 of the first embodiment. The ablation catheter 100 of this embodiment also includes a catheter body 110 , an ablation assembly 120 and a traction tube 130 .

[0145] The catheter body 110 , the ablation assembly 120 and the traction tube 130 in the third embodiment are the same as those in the first embodiment, and are not described again.

[0146] The ablation catheter 100 of the third embodiment differs from the ablation catheter 100 of the first embodiment mainly in that the ablation catheter 100 further includes a distal connector 132 for connecting the distal end of the traction tube 130 with the distal ends of the plurality of bearing rods 1212 - 10 of the support frame 121 .

[0147] Specifically, the distal end of the distal connector 132 is used to be connected to the distal ends of multiple load-bearing rods 1212-10, so that the multiple load-bearing rods 1212-10 converge on the distal connector 132, and the proximal end of the distal connector 132 is used to be connected to the distal end of the traction tube 130, so that the traction tube 130 drives the multiple load-bearing rods 1212-10 to expand or contract radially at one end away from the distal connector 132 through axial movement.

[0148] like Fig.17 As shown, the distal connection member 132 includes a first connection portion 1321 and a second connection portion 1322 connected to each other, and the first connection portion 1321 is arranged at the distal end relative to the second connection portion 1322. The second connection portion 1322 is inserted into the interior of the distal end of the traction tube 130, and the first connection portion 1321 and the traction tube 130 are stopped in the axial direction. The first connection portion 1321 is provided with a plurality of positioning holes 1321-11, and the plurality of bearing rods 1212-10 are respectively fixed in the plurality of positioning holes 1321-11.

[0149] At least one notch 13222 is provided on the outer peripheral surface of the second connection portion 1322 , and a sealing layer (not shown in the figure) is connected between the traction tube 130 and the second connection portion 1322 , and the sealing layer includes a protrusion (not shown in the figure) embedded in the notch 13222 .

[0150] The outer peripheral wall of the second connecting portion 1322 is provided with a plurality of receiving grooves 13223 extending along the axial direction thereof. A blocking rib 13221 is formed between any two circumferentially adjacent receiving grooves 13223 , and the notch 13222 is provided on the blocking rib 13221 .

[0151] The first connection portion 1321 may be configured as follows Fig.17The cylindrical base shown in the figure has a chamfered or rounded corner on the edge of the end face of one axial end of the cylindrical base (i.e., the proximal end of the first connecting portion 1321), so that the first connecting portion 1321 and the second connecting portion 1322 have a smooth transition. A plurality of positioning holes 1321-11 are provided on the end face of the other axial end of the cylindrical base (i.e., the distal end of the first connecting portion 1321) along its axial direction, and the plurality of positioning holes 1321-11 are arranged circumferentially and spaced around the central axis of the first connecting portion 1321. Optionally, the plurality of positioning holes 1321-11 are evenly arranged circumferentially, and each positioning hole 1321-11 axially penetrates the proximal and distal surfaces of the first connecting portion 1321, so that the positioning hole 1321-11 has a distal port on the distal surface of the first connecting portion 1321, and the positioning hole 1321-11 has a proximal port on the proximal surface of the first connecting portion 1321, wherein the distal port is arranged with a chamfered or rounded corner. The distal ends of the multiple bearing rods 1212-10 are plugged into the multiple positioning holes 1321-11 along the distal end ports in a one-to-one correspondence. The rounded corners can reduce the contact stress of the distal ends of the bearing rods 1212-10 and prevent the distal ends of the bearing rods 1212-10 from breaking. More specifically, the farthest end of the rod body of the bearing rod 1212-10 extends into the positioning hole 1321-11, and the distal end surface of the insulating sleeve on the surface of the rod body is connected to the proximal end port of the positioning hole 1321-11. Optionally, each positioning hole 1321-11 can be but is not limited to any one of a cylindrical through hole, a square through hole, a rectangular through hole, a square through hole with rounded corners, and a rectangular through hole with rounded corners. The shapes of the multiple positioning holes 1321-11 can be the same or different, and the sizes of the multiple positioning holes 1321-11 can also be the same or different. In this embodiment, the plurality of positioning holes 1321 - 11 are all cylindrical through holes with the same size.

[0152] The second connection part 1322 is configured as a cylindrical body, and the outer peripheral wall of the second connection part 1322 is provided with a plurality of receiving grooves 13223 extending along its axial direction, and the space of the receiving grooves 13223 can be used for the wires of the ablation electrode 122 and / or the mapping electrode 123 to pass through. Among them, the plurality of receiving grooves 13223 are connected one-to-one with the plurality of positioning holes 1321-11. Optionally, the geometric center of a positioning hole 1321-11 on the first connection part 1321 corresponds to the axis of a receiving groove 13223 on the second connection part 1322, and the positioning hole 1321-11 is connected with the corresponding receiving groove 13223, so that the protection effect on the wire is better and the operation of threading the wire is also facilitated. The shape of the cross section of each receiving groove 13223 perpendicular to its axial direction includes one of an arc, a rectangle and a waist shape. The shapes of the cross sections of the multiple receiving grooves 13223 perpendicular to their axial directions may be the same or different, and the sizes (including axial length and radial depth) of the multiple receiving grooves 13223 may also be the same or different. In this embodiment, the multiple receiving grooves 13223 are arc-shaped grooves with the same size.

[0153] A plurality of notches 13222 are also provided on the outer peripheral wall of the second connection part 1322. In more detail, a blocking rib 13221 is formed between any two circumferentially adjacent receiving grooves 13223, and at least one blocking rib 13221 is provided with a notch 13222. The distal end of the traction tube 130 is sleeved on the outer side of the second connection part 1322, and the second connection part 1322 and the traction tube 130 are connected by gluing, so that each notch 13222 corresponds to a "glue position", that is, the first glue sealing layer formed after the glue solidifies, wherein the first glue sealing layer forms a protrusion matching the shape of the notch 13222 at each notch 13222, and the clamping connection formed by the protrusion and the notch 13222 can better limit the traction tube 130 and improve the connection reliability.

[0154] In this example, if Fig.16 As shown, since the proximal portion of the ablation component 120 is a uniformly distributed grid structure (i.e., referring to the ablation catheter 100 of the first embodiment, the proximal end of the support skeleton 121 is a first frame 1211 with a grid structure), and the support rod 1212-10 of the distal portion is inserted and connected through the positioning holes 1321-11 uniformly distributed at the distal end of the distal connector 132, in this way, the distal end of the support rod 1212-10 is uniformly distributed based on the distribution design of the positioning holes 1321-11, so that the ablation component 120 maintains its integrity to the greatest extent, avoids the spiral phenomenon, ensures the uniform distribution between the ablation electrodes 122 and / or the mapping electrodes 123, and also ensures the uniformity of ablation. In addition, the notch 13222 provided at the second connecting portion 1322 forms a snap connection with the protrusion of the first glue sealing layer, which better ensures the connection reliability between the catheter body 110 of the traction tube 130 and the distal connector 132.

[0155] Fourth embodiment

[0156] refer to Fig.18 This embodiment provides a distal connector 132 of an ablation catheter 100 , and the distal connector 132 can be used to replace the distal connector 132 of the ablation catheter 100 of the third embodiment.

[0157] like Fig.18 As shown, the distal connection member 132 includes a first connection portion 1321 and a second connection portion 1322, and the second connection portion 1322 is disposed at the proximal end of the first connection portion 1321. The distal connection member 132 of this embodiment differs from the distal connection member 132 in the third embodiment as follows:

[0158] The first connection portion 1321 may be configured as follows Fig.18In the cylindrical base shown in FIG, a plurality of positioning holes 1321-11 are provided on the outer peripheral wall of the first connecting portion 1321 near the distal end of the first connecting portion 1321, and the plurality of positioning holes 1321-11 are arranged circumferentially at intervals around the central axis of the first connecting portion 1321. The positioning holes 1321-11 are used for inserting and connecting a plurality of bearing rods 1212-10 one by one.

[0159] The distal edge of the first connecting portion 1321 is provided with a rounded corner, which is approximately tangent to or has a relatively rounded transition with the distal ends of the plurality of bearing rods 1212 - 10 , which is conducive to achieving wall-adherent ablation.

[0160] The first connecting portion 1321 is further provided with a plurality of axial holes 1321 - 21 , each of which is interconnected with the corresponding positioning hole 1321 - 11 , and each of which is interconnected with the corresponding receiving groove 13223 , and the receiving groove 13223 is used for passing the wires of the ablation electrode 122 and the mapping electrode 123 .

[0161] The second connection part 1322 is configured as a cylindrical body, and the outer peripheral wall of the second connection part 1322 is provided with a plurality of receiving grooves 13223 extending along its axial direction, and the space of the receiving grooves 13223 can be used for the wires of the ablation electrode 122 and the mapping electrode 123 to pass through. Among them, the plurality of receiving grooves 13223 are connected one-to-one with the plurality of axial holes 1321-21. Optionally, the geometric center of an axial hole 1321-21 on the first connection part 1321 corresponds to the axis of a receiving groove 13223 on the second connection part 1322, and the axial hole 1321-21 is connected with the corresponding receiving groove 13223, so that the protection effect on the wire is better and the operation of threading the wire is also facilitated. The shape of the cross section of each receiving groove 13223 perpendicular to its axial direction includes one of an arc, a rectangle and a waist shape. The shapes of the cross sections perpendicular to the axial direction of the plurality of receiving grooves 13223 may be the same or different, and the sizes (including axial length and radial depth) of the plurality of receiving grooves 13223 may also be the same or different. In this embodiment, the plurality of receiving grooves 13223 are arc-shaped grooves with the same size.

[0162] A plurality of notches 13222 are also provided on the outer peripheral wall of the second connection part 1322. In more detail, a blocking rib 13221 is formed between any two circumferentially adjacent receiving grooves 13223, and at least one blocking rib 13221 is provided with a notch 13222. The distal end of the traction tube 130 is sleeved on the outer side of the second connection part 1322, and the second connection part 1322 and the traction tube 130 are connected by gluing, so that each notch 13222 corresponds to a "glue position", that is, the first glue sealing layer formed after the glue solidifies, wherein the first glue sealing layer forms a protrusion matching the shape of the notch 13222 at each notch 13222, and the clamping connection formed by the protrusion and the notch 13222 can better limit the traction tube 130 and improve the connection reliability.

[0163] Fifth embodiment

[0164] Please refer to Figures 19 to 21 The ablation catheter 100 of the fifth embodiment has substantially the same structure as the ablation catheter 100 of the third embodiment, and the main difference is that the ablation catheter 100 further includes a first proximal connector 111 and a second proximal connector 112. The first proximal connector 111 and the second proximal connector 112 are used to fix the proximal end of the ablation assembly 120 and the distal end of the catheter body 110.

[0165] Specifically, the first proximal connecting member 111 includes a first fixing tube 1111, a second fixing tube 1112 and an annular wall 1113. The radial dimension of the first fixing tube 1111 is larger than that of the second fixing tube 1112. The second fixing tube 1112 is arranged at the distal end of the first fixing tube 1111. A radially extending annular wall 1113 is provided between the second fixing tube 1112 and the first fixing tube 1111. The second proximal connecting member 112 includes a third fixing tube 1121. When used in combination, the third fixing tube 1121 is nested in the second fixing tube 111 2, the proximal end of the third fixed tube 1121 stops at the annular wall 1113, the outer circumferential surface of the third fixed tube 1121 is smoothly connected to the outer circumferential surface of the first fixed tube 1111, and a tube gap 113 is formed between the inner circumferential surface of the third fixed tube 1121 and the outer circumferential surface of the second fixed tube 1112; the proximal end of the first frame body 1211 is provided with a plurality of circumferentially distributed connecting ribs 1211-3, and the connecting ribs 1211-3 are inserted into the tube gap 113; the distal end of the catheter body 110 is nested in the first fixed tube 1111 and stops at the annular wall 1113.

[0166] Afterwards, the wire 151 of the first frame 1211 is welded to the first frame 1211, so that one end of the wire 151 of the first frame 1211 is connected to the first frame 1211, and the other end passes through the first fixed tube 1111 or the connecting hole on the annular wall 1113 (not shown in the figure), and is connected to the tail end handle via the wire channel 1143 in the tube wall 1146 of the catheter body 110. After that, the proximal end of the ablation component 120 is fixedly connected to the second proximal connecting piece 112 and the first proximal connecting piece 111 by injecting glue into the tube gap 113. In this way, the glue is cured in the tube gap 113 to form a second glue sealing layer, and the connecting rib 1211-3 at the proximal end of the first frame 1211 is fixed in the tube gap 113 by the second glue sealing layer formed by the solidified glue.

[0167] The axial length of the second fixing tube 1112 is greater than that of the third fixing tube 1121, and the distal end of the second fixing tube 1112 extends from the distal end of the third fixing tube 1121. In this way, the second fixing tube 1112 is used to protect the traction tube 130 to prevent the traction tube 130 from scratching the first frame 1211 during axial movement.

[0168] The annular wall 1113 is provided with a connection hole. The conductive portion of the first frame 1211 is connected to a wire 151 . The wire 151 passes through the connection hole of the annular wall 1113 and is arranged in a wire channel 1143 . The wire channel 1143 is opened in the tube wall 1146 of the catheter body 110 .

[0169] In this embodiment, a tube gap 113 is formed by the first proximal connector 111 and the second proximal connector 112, and the connecting rib 1211-3 is connected to the first proximal connector 111 and the second proximal connector 112 through the tube gap 113, and the first proximal connector 111 is connected to the catheter body 110, thereby realizing the connection between the proximal end of the ablation component 120 and the distal end of the catheter body 110. Since the tube gap 113 is not connected to the interior of the catheter body 110, the glue injected into the tube gap 113 will not enter the interior of the catheter body 110, and the sheath core will not be stuck due to the penetration of the glue. In addition, the cooperation between the first proximal connector 111 and the second proximal connector 112 enables the connection strength to meet the design requirements, thereby avoiding the risk of the ablation component 120 falling off.

[0170] Optionally, one or more of the second proximal connector 112, the first proximal connector 111, and the distal connector 132 in the third embodiment, the fourth embodiment, and the fifth embodiment may be made of a biocompatible metal material or an insulating material, the metal material may be but not limited to cobalt-chromium alloy or stainless steel, the insulating material may be but not limited to FEP (Fluorinated ethylene propylene), ETFE (Ethylene-Tetra-Fluoro-Ethylene, ethylene-tetrafluoroethylene copolymer, commonly known as: F-40) or PFA (Poly Fluoro Alkoxy, soluble polytetrafluoroethylene).

[0171] Although the present application has been described with reference to several typical embodiments, it should be understood that the terms used are illustrative and exemplary, rather than restrictive. Since the present application can be implemented in a variety of forms without departing from the spirit or essence of the invention, it should be understood that the above embodiments are not limited to any of the foregoing details, but should be interpreted broadly within the spirit and scope defined by the appended claims, so all changes and modifications falling within the scope of the claims or their equivalents should be covered by the appended claims.

Claims

1. An ablation catheter, characterized in that: include: a catheter body; A support frame is arranged at the distal end of the catheter body, the support frame has an equatorial position between the proximal end and the distal end thereof, the support frame comprises a first frame body and a second frame body, the second frame body is arranged at the distal end relative to the first frame body, the proximal end of the first frame body is connected to the distal end of the catheter body, the distal end of the first frame body is connected to the proximal end of the second frame body, and the first frame body is entirely or partially arranged as a conductive part; At least one ablation electrode is disposed on the second frame, at least one of the ablation electrodes is located between the equatorial position and the distal end of the second frame, the total area of ​​the ablation electrodes is smaller than the total area of ​​the conductive portion, and the ablation electrode cooperates with the conductive portion to transmit ablation energy to the target tissue area for ablation; At least one mapping electrode is arranged on the second frame, at least one of the mapping electrodes is located at the equatorial position or between the equatorial position and the proximal end of the second frame, and the mapping electrode is used to detect electrophysiological signals of the target tissue area.

2. The ablation catheter according to claim 1, characterized in that: The first frame is integrally constructed as the conductive part, wherein the conductive part is electrically connected to one pole of the external energy generator, and at least one ablation electrode is electrically connected to the other pole of the external energy generator to transmit the ablation energy output by the external energy generator to the target tissue area.

3. The ablation catheter according to claim 1, characterized in that: An axial length of the first frame body is smaller than an axial length of the second frame body.

4. The ablation catheter according to claim 1, characterized in that: The first frame is a grid structure with a plurality of pillars connected end to end, the proximal end of the grid structure is connected to the distal end of the catheter body, and the distal end of the grid structure is connected to the proximal end of the second frame.

5. The ablation catheter according to claim 4, characterized in that: The grid structure includes a plurality of grid groups, which are arranged circumferentially around the central axis of the support frame, the distal end of each grid group is connected to the proximal end of the second frame, the proximal end of each grid group is connected to the distal end of the catheter body, and two adjacent grid groups are connected to each other in the circumferential direction of the support frame.

6. The ablation catheter according to claim 5, characterized in that: The grid structure further includes a plurality of connecting grids, and two adjacent grid groups are connected in the circumferential direction of the supporting skeleton by at least one connecting grid.

7. The ablation catheter according to claim 6, characterized in that: Each of the grid groups includes at least one main grid, at least one connecting grid is arranged between two adjacent grid groups, at least one connecting grid reuses one side with each main grid in two adjacent grid groups, and the outlines of the main grid and the connecting grid are both polygonal.

8. The ablation catheter according to claim 6, characterized in that: Each of the grid groups includes a first main grid and a second main grid, the first main grid and the second main grid share a grid node, and the second main grids of two adjacent grid groups reuse one side; The distal end of the first main grid is correspondingly connected to the proximal end of the second frame, the second main grid is a polygon opening toward the catheter body, and the proximal end of the second main grid is connected to the distal end of the catheter body; A connection grid is provided between two adjacent grid groups, and the connection grid reuses one side with each of the first main grids and each of the second main grids in the two adjacent grid groups.

9. The ablation catheter according to claim 8, characterized in that: The connected grid includes a first sub-grid and a second sub-grid, the first sub-grid and the second sub-grid reuse one side, the first sub-grid and the first main grid and the second main grid in one of the adjacent grid groups reuse one side respectively, and the second sub-grid and the first main grid and the second main grid in another adjacent grid group reuse one side respectively.

10. The ablation catheter according to any one of claims 1 to 9, characterized in that: The second frame includes a plurality of supporting rods, which are spaced apart around the central axis of the supporting frame, the distal ends of the supporting rods are close to the central axis of the supporting frame and fixed to each other, the proximal ends of the supporting rods are connected to the distal end of the first frame, and at least one ablation electrode and at least one mapping electrode are arranged on the supporting rods.

11. The ablation catheter according to claim 10, characterized in that: There are a plurality of ablation electrodes, and at least one ablation electrode is disposed on each of the support rods. The ablation electrode is located between a position on the support rod corresponding to the equator and a distal end of the support rod.

12. The ablation catheter according to claim 10, characterized in that: The plurality of bearing bars include a plurality of first bearing bars and a plurality of second bearing bars, and the plurality of first bearing bars and the plurality of second bearing bars are alternately arranged around the central axis of the supporting frame; At least one of the mapping electrodes is disposed on the first supporting rod and is located at a position on the first supporting rod corresponding to the equatorial position, or is located between a position on the first supporting rod corresponding to the equatorial position and a proximal end of the first supporting rod, or, At least one of the mapping electrodes is disposed on the second supporting rod and is located at a position on the second supporting rod corresponding to the equatorial position, or is located between a position on the second supporting rod corresponding to the equatorial position and a proximal end of the second supporting rod.

13. The ablation catheter according to claim 12, characterized in that: There are a plurality of the mapping electrodes, and at least one mapping electrode is disposed on each of the first supporting rods or each of the second supporting rods.

14. The ablation catheter according to claim 12, characterized in that: The end of the first frame body facing the second frame body includes a first connection end and a second connection end, and the first connection end is closer to the proximal end of the first frame body than the second connection end; When at least one of the mapping electrodes is disposed on the first bearing rod, the length of the first bearing rod is longer than the length of the second bearing rod, the proximal end of the first bearing rod is connected to the first connecting end, and the proximal end of the second bearing rod is connected to the second connecting end; or When at least one of the mapping electrodes is arranged on the second supporting rod, the length of the second supporting rod is longer than that of the first supporting rod, the proximal end of the second supporting rod is connected to the first connecting end, and the proximal end of the first supporting rod is connected to the second connecting end.

15. The ablation catheter according to claim 10, characterized in that: The ablation catheter further comprises: A traction tube is movably arranged in the catheter body and extends out of the distal end of the catheter body. The distal ends of the plurality of bearing rods converge at the distal end of the traction tube.

16. The ablation catheter according to claim 15, characterized in that: The supporting rod includes a rod body and an insulating sleeve sleeved on the rod body, at least one ablation electrode and at least one mapping electrode are arranged on the insulating sleeve, wherein the distal end of the rod body is exposed relative to the distal end of the insulating sleeve and forms a bending portion, the bending portion is fixed in the traction tube, and the farthest end of the insulating sleeve is connected to the farthest end of the traction tube.

17. The ablation catheter according to claim 15, characterized in that: Also includes: A distal end connecting piece, through which the distal ends of the plurality of bearing rods are connected to the distal end of the traction tube.

18. The ablation catheter according to claim 17, characterized in that: The distal connecting member includes a first connecting part and a second connecting part connected to each other, the first connecting part is arranged at the distal end relative to the second connecting part, the second connecting part is inserted into the interior of the traction tube, the first connecting part is stopped by the traction tube, the first connecting part is provided with a plurality of positioning holes, and the plurality of bearing rods are respectively fixed in the plurality of positioning holes.

19. The ablation catheter according to claim 18, characterized in that: At least one notch is arranged on the outer peripheral surface of the second connecting part, and a glue sealing layer is connected between the traction tube and the second connecting part, wherein the glue sealing layer includes a protrusion embedded in the notch.

20. The ablation catheter according to claim 19, characterized in that: The outer peripheral wall of the second connecting portion is provided with a plurality of receiving grooves extending along the axial direction thereof, a blocking rib is formed between any two circumferentially adjacent receiving grooves, and the notch is provided on the blocking rib.

21. The ablation catheter according to claim 20, characterized in that: The first connecting portion is provided with a plurality of positioning holes along its axial direction, and the plurality of positioning holes are circumferentially spaced around the central axis of the first connecting portion. The plurality of positioning holes correspond one-to-one to the plurality of receiving grooves, and each of the positioning holes is interconnected with the corresponding receiving groove, and the receiving groove is used for passing the wires of the ablation electrode and the mapping electrode.

22. The ablation catheter according to claim 21, characterized in that: The positioning hole has a distal end port on the distal end surface of the first connecting portion, and the distal end port is arranged with a chamfered angle or a rounded angle.

23. The ablation catheter according to claim 20, characterized in that: A plurality of positioning holes are formed on an outer peripheral wall of the first connecting portion close to a distal end of the first connecting portion, and the plurality of positioning holes are circumferentially spaced around a central axis of the first connecting portion.

24. The ablation catheter according to claim 23, characterized in that: The first connecting portion is also provided with a plurality of axial holes, each of which is communicated with the corresponding positioning hole, and each of which is communicated with the corresponding receiving groove, and the receiving groove is used for passing the wires of the ablation electrode and the mapping electrode.

25. The ablation catheter according to claim 15, characterized in that: The ablation catheter further comprises: A reference electrode is disposed on the catheter body and / or the traction tube, and is used for electrocardiogram signal mapping to obtain a reference potential.

26. The ablation catheter according to claim 1, characterized in that: When the support frame is in an expanded state, the distal end of the support frame forms a distal plane, wherein at least one ablation electrode is distributed in the distal plane.

27. The ablation catheter according to claim 1, characterized in that: The width of the mapping electrode is less than or equal to the width of the ablation electrode.

28. The ablation catheter according to claim 1, characterized in that The catheter body includes a bending section and a supporting section, the proximal end of the bending section is connected to the distal end of the supporting section; the conductive part is connected to a wire, the wire is axially inserted into a wire channel, and the wire channel is opened in the tube wall of the bending section and the tube wall of the supporting section, wherein the wire in the wire channel corresponding to the bending section is spiral, wavy or zigzag.

29. The ablation catheter according to claim 1, characterized in that: Also includes: The first proximal connecting member comprises a first fixing tube, a second fixing tube and an annular wall, wherein the radial dimension of the first fixing tube is larger than that of the second fixing tube, the second fixing tube is arranged at the distal end of the first fixing tube, and a radially extending annular wall is provided between the second fixing tube and the first fixing tube; The second proximal connecting member comprises a third fixing tube, wherein the third fixing tube is nested on the outside of the second fixing tube, the proximal end of the third fixing tube abuts against the annular wall, and a tube gap is formed between the third fixing tube and the second fixing tube, wherein the proximal end of the first frame is fixed in the tube gap; The distal end of the catheter body is nested in the first fixing tube and stops on the annular wall.

30. The ablation catheter according to claim 29, characterized in that The axial length of the second fixing tube is greater than that of the third fixing tube, and the distal end of the second fixing tube extends out from the distal end of the third fixing tube.

31. The ablation catheter according to claim 29, characterized in that The outer circumferential surface of the third fixing tube is smoothly connected to the outer circumferential surface of the first fixing tube.

32. The ablation catheter according to claim 29, characterized in that The annular wall is provided with a connecting hole, the conductive part is connected with a conducting wire, the conducting wire passes through the connecting hole and is arranged in a conducting wire channel, and the conducting wire channel is opened in the tube wall of the catheter body.

33. The ablation catheter according to claim 29, characterized in that A glue sealing layer is arranged in the tube gap, and the proximal end of the first frame is fixedly connected to the glue sealing layer.

34. The ablation catheter according to claim 1, characterized in that: A braided mesh is embedded in the tube wall of the catheter body.

35. An ablation system, characterized in that: It comprises a pulse ablation device and the ablation catheter according to any one of claims 1 to 34, wherein the ablation catheter is connected to the pulse ablation device.

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