CN218075202U

CN218075202U - Ablation catheter and ablation system

Info

Publication number: CN218075202U
Application number: CN202221510983.XU
Authority: CN
Inventors: 徐剑刚; 王永胜; 刘成
Original assignee: Hangzhou Dinova EP Technology Co Ltd
Current assignee: Hangzhou Dinova EP Technology Co Ltd
Priority date: 2022-06-15
Filing date: 2022-06-15
Publication date: 2022-12-20
Anticipated expiration: 2032-06-15

Abstract

The application provides an ablation catheter and an ablation system. The ablation catheter includes a catheter body, a first electrode, and a second electrode. The proximal end of the first electrode is connected with the distal end of the tube body. The second electrode is arranged in the first electrode and insulated from the first electrode. The ablation catheter can be switched between a radio frequency ablation mode and a pulse ablation mode by controlling the electric conduction state of the first electrode and the second electrode, wherein in the radio frequency ablation mode, the ablation catheter carries out radio frequency ablation, and in the pulse ablation mode, the ablation catheter carries out pulse ablation. Like this, the ablation catheter can realize the free switching of ablation process energy, and at the ablation in-process, the operation operator can select more suitable energy mode according to operation position complexity, patient actual conditions or operation experience and carry out the ablation, promotes the flexibility of ablation process to the complexity of significantly reduced operation increases the maneuverability of operation, effectively shortens the operation time, reduces the risk in the operation process.

Description

Ablation catheter and ablation system

Technical Field

The utility model relates to the field of medical equipment, in particular to melt pipe and system of melting.

Background

With the development of economy, aging population and lifestyle changes, chronic non-infectious diseases mainly including cardiovascular and cerebrovascular diseases are becoming major diseases affecting life health. Cardiovascular and cerebrovascular diseases mainly include atrial fibrillation, structural heart disease, heart failure and the like. The harm of atrial fibrillation mainly shows high fatality rate, high disability rate and high recurrence rate. According to statistics of relevant data, the high disability rate of atrial fibrillation in China is 73%, the high fatality rate of atrial fibrillation is 50%, and the high recurrence rate of atrial fibrillation in China is 69%.

In recent years, radio frequency ablation is gradually becoming one of important means for catheter ablation to treat atrial fibrillation, and although complications of atrial fibrillation radio frequency ablation tend to be reduced along with accumulation of experience and continuous improvement of related radio frequency ablation catheter design and production technologies, the incidence rate can still reach 5%, and the consequences are serious once part of the complications occur, so that new energy sources are needed to assist radio frequency ablation. The pulse electric field energy forms irreversible micropores on a cell membrane through instant discharge to cause cell apoptosis, so that the aim of non-thermal ablation is fulfilled.

However, the existing ablation catheters are not compatible with radiofrequency ablation and pulsed electric field ablation at the same time, the ablation mode is single, the flexibility of the operation is reduced, and the complexity of the operation is increased. Therefore, in order to meet the needs of a wide range of ablations, it is necessary to develop an ablation catheter that is compatible with multiple ablation modalities.

SUMMERY OF THE UTILITY MODEL

The embodiment of the application provides an ablation catheter and an ablation system which are compatible with multiple ablation modes.

In a first aspect, the present application provides an ablation catheter. The ablation catheter includes a catheter body, a first electrode, and a second electrode. The proximal end of the first electrode is connected with the distal end of the tube body. The second electrode is arranged in the first electrode and insulated from the first electrode. The ablation catheter can be switched between a radio frequency ablation mode and a pulse ablation mode by controlling the electric conduction state of the first electrode and the second electrode, wherein in the radio frequency ablation mode, the ablation catheter carries out radio frequency ablation, and in the pulse ablation mode, the ablation catheter carries out pulse ablation.

In a second aspect, the present application provides an ablation system. The ablation system comprises an energy output device and an ablation catheter, wherein the energy output device is used for selectively outputting radio frequency ablation energy and pulse ablation energy to the ablation catheter.

An ablation catheter of the present application includes a catheter body, a first electrode, and a second electrode. The ablation catheter can be switched between a radio frequency ablation mode and a pulse ablation mode by controlling the electric conduction state of the first electrode and the second electrode, wherein in the radio frequency ablation mode, the ablation catheter carries out radio frequency ablation, and in the pulse ablation mode, the ablation catheter carries out pulse ablation. Like this, the ablation catheter can realize the free switching of ablation process energy, and at the ablation in-process, the operation operator can select more suitable energy mode according to operation position complexity, patient actual conditions or operation experience and carry out the ablation, promotes the flexibility of ablation process to the complexity of significantly reduced operation increases the maneuverability of operation, effectively shortens the operation time, reduces the risk in the operation process.

Drawings

In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings used in the embodiments or the prior art descriptions will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present application, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic illustration of ablation energy delivery in an ablation system provided herein;

fig. 2 is a schematic view of an ablation catheter structure provided in accordance with an embodiment of the present application;

fig. 3 is a schematic view of a positional relationship of the first electrode and the second electrode shown in fig. 2;

FIG. 4 isbase:Sub>A schematic cross-sectional view taken along line A-A of FIG. 3;

FIG. 5 is a schematic cross-sectional view taken along line B-B of FIG. 3;

FIG. 6 is a schematic cross-sectional view at C-C of FIG. 3;

fig. 7 is a schematic structural view of an ablation catheter provided in accordance with a second embodiment of the present application;

fig. 8 is a schematic structural diagram of an ablation catheter provided in the third embodiment of the present application.

Detailed Description

The technical solutions in the embodiments of the present application will be described clearly and completely with reference to the drawings in the embodiments of the present application, and it is obvious that the described embodiments are only some embodiments of the present application, and not all embodiments. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments in the present application without making any creative effort belong to the protection scope of the present application.

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used in the description of the present application herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

In the description of the embodiments of the present application, it should be noted that "scheme a and/or B" includes scheme a and scheme B and scheme AB. In this application "proximal" refers to the end of the medical instrument that is closer to the operator and "distal" refers to the end of the medical instrument that is further from the operator.

Referring to fig. 1, fig. 1 is a schematic diagram illustrating delivery of ablation energy in an ablation system 1000 provided herein. The ablation system 1000 includes an ablation catheter 100 and an energy output device 200. The energy output device 200 is used to selectively output radiofrequency ablation energy and pulse ablation energy to the ablation catheter 100. The ablation catheter 100 is used for releasing radiofrequency ablation energy and pulse ablation energy to ablate target tissues, thereby achieving the purpose of treating diseases. The target tissue is the focal tissue region that needs to be ablated during the ablation procedure.

The energy output device 200 includes an external radio frequency generator 210 and an external pulse generator 220. The external radio frequency generator 210 and the external pulse generator 220 are electrically connected to the ablation catheter 100. The external radio frequency generator 210 is used to send high frequency current to the ablation catheter 100 to achieve radio frequency ablation. The external pulse generator 220 is used to send a pulsed current to the ablation catheter 100 to effect pulsed ablation.

The ablation system 1000 provided by the present application may be used for cardiac ablation, and may also be used for ablation of different sites or diseases such as renal artery ablation and bronchial ablation, which is not limited in the present application. The ablation system 1000 provided herein is described in the context of cardiac ablation.

The ablation catheter 100 embodiments of the present application are described in detail below with reference to the drawings.

Example one

Referring to fig. 2 to 6, the ablation catheter 100 includes a first electrode 10, a second electrode 20, at least one third electrode 30, and a catheter body 40. The proximal end of the first electrode 10 is connected to the distal end of the tube 40. The surface of the first electrode 10 is smooth and free of sharp corners. In this way, normal tissue is protected from being easily damaged while achieving good abutment of the ablation catheter 100 to the target tissue. In one embodiment, the first electrode 10 is a smooth flat surface or a smooth curved surface (e.g., a spherical surface).

The first electrode 10 is a cylindrical structure, and the distal end of the first electrode 10 is smoothly transited to the outer peripheral surface of the tube 40. At the same time, the distal portion of the first electrode 10 has rounded corners that are large enough (e.g., greater than 90 °) to maximize the placement of the first electrode 10 against the tissue during the ablation process, resulting in better ablation. In other ways, the first electrode 10 may be an elliptical cylinder.

The axial length of the first electrode 10 is in the range 3mm to 8mm and the radial width is in the range 1mm to 4mm. In the present embodiment, the axial length of the first electrode 10 is 5mm, and the radial width of the first electrode 10 is 2.8mm.

Referring to fig. 3, the second electrode 20 is disposed in the first electrode 10 and insulated from the first electrode 10. The second electrode 20 is located inside the first electrode 10, which means that the second electrode 20 is embedded in the first electrode 10. In addition, one end of the second electrode 20 is exposed out of the surface of the first electrode 10, and the portion of the second electrode 20 exposed out of the first electrode 10 is flush with the surface of the first electrode 10. Thus, when an ablation operation is performed, on one hand, one end of the second electrode 20 exposed out of the surface of the first electrode 10 can be attached to a target tissue for ablation and/or mapping, and on the other hand, the outer surface of the first electrode 10 can be ensured to be smooth and free of protrusions, so that the tissue is protected from being scratched easily.

The second electrode 20 is smaller in size than the first electrode 10, and target tissue having a smaller lesion area can be ablated by the second electrode 20.

The side surface of the first electrode 10 is provided with a mounting hole 11, and the mounting hole 11 is used for mounting the second electrode 20. In one embodiment, an insulating ring 12 is disposed in the mounting hole 11, and the insulating ring 12 is sleeved outside the second electrode 20, so as to insulate the first electrode 10 and the second electrode 20 from each other. The insulating ring 12 can be made of organic insulating materials such as rubber and plastic, and has good insulating property and long service life. In other embodiments, the second electrode 20 may also be connected to the first electrode 10 by gluing, and the insulation between the first electrode 10 and the second electrode 20 is achieved by glue.

The second electrode 20 is made of metal, and the second electrode 20 is cylindrical and embedded in the first electrode 10. The diameter of the second electrode 20 is preferably 0.8mm and the thickness of the insulating ring 12 is preferably 0.1mm.

The number of the second electrodes 20 may be one or more. In this embodiment, the number of the second electrodes 20 is plural, the plural second electrodes 20 are disposed in the first electrode 10 and are spaced apart from each other and insulated, and the plural second electrodes 20 are circumferentially arranged around the axial center line of the first electrode 10. The scheme of arranging around circumference makes second electrode 20 can distribute in the circumference of first electrode 10 all-round to realize the ablation in multiple directions, it is better to ablate the effect.

Specifically, the plurality of second electrodes 20 arranged around the circumferential direction enclose a ring shape in the circumferential direction of the first electrode 10, and the plane of the ring shape is perpendicular to the axial line of the first electrode 10. It should be noted that, the ring shape here is a ring shape formed by connecting the positions of the plurality of second electrodes 20 in sequence along the surface of the first electrode 10, and the last connecting line. In other embodiments, the plane of the ring may be at a non-right angle to the axis of the first electrode 10. The plurality of second electrodes 20 in the ring shape are evenly or unevenly spaced along the circumference of the first electrode 10.

More specifically, a plurality of rings are sequentially arranged on the first electrode 10 along the axial direction, and any one of the second electrodes 20 included in one of the two adjacent rings is arranged in a staggered manner with any one of the second electrodes 20 included in the other ring along the circumferential direction of the first electrode 10. The plurality of rings may be arranged at equal intervals or at unequal intervals in the axial direction, and the number of the plurality of second electrodes 20 in each ring may be equal or unequal.

In this embodiment, three rings, i.e., a first ring 21, a second ring 22, and a third ring 23, are sequentially disposed at equal intervals along the axial direction on the first electrode 10. The first ring 21 includes three second electrodes 211, the second ring 22 includes three second electrodes 221, the third ring 23 includes three second electrodes 231, and an included angle between two adjacent second electrodes 211 in the first ring 21, an included angle between two adjacent second electrodes 221 in the second ring 22, and an included angle between two adjacent second electrodes 231 in the third ring 23 are all 120 °. The second electrode 211 of the first ring 21 and the second electrode 221 of the second ring 22 are arranged to be displaced in the circumferential direction of the first electrode 10, and the second electrode 221 of the second ring 22 and the second electrode 231 of the third ring 23 are arranged to be displaced in the circumferential direction of the first electrode 10. Compared with the mode of alignment, the staggered mode enables the distance between the second electrodes 20 included in the adjacent rings to be increased, so that the coverage of the electric field is larger, and the distribution of the electric field is more uniform. In other embodiments, the number of loops provided on the first electrode 10 may also be one, two, four, or any other suitable number.

At least one third electrode 30 is further disposed on the outer wall of the tube 40, and the third electrode 30 is spaced apart from the first electrode 10. In the present embodiment, the ablation catheter 100 includes three third electrodes 30, the three third electrodes 30 being insulated from each other and the third electrode 30 adjacent to the first electrode 10 being insulated from the first electrode 10. From the distal end to the proximal end in the axial direction of the tubular body 40 are a third electrode 31, a third electrode 32, and a third electrode 33, respectively. In this embodiment, the third electrode 30 is annular and is disposed on the outer wall of the tube 40. In other embodiments, the third electrode 30 may have other shapes, such as a sheet, a dot, a sphere, a 1/2 circular ring, a 1/3 circular ring, etc.

The axial dimensions of the third electrode 30 are all 1mm. The distance between the first electrode 10 and the third electrode 31 along the axial direction of the tube 40 is in the range of 1mm to 2 mm. The distance between the third electrode 31 and the third electrode 32 is in the range of 2mm to 8mm. The third electrode 32 is spaced from the third electrode 33 by a distance in the range of 1mm to 2 mm. Note that, the pitch here is the pitch between the adjacent end faces of the different electrodes. In the present embodiment, the distance between the first electrode 10 and the third electrode 31 is 1mm along the axial direction of the tube 40. The third electrode 31 and the third electrode 32 are spaced apart by 4mm. The third electrode 32 and the third electrode 33 are spaced apart by 1mm. In other embodiments, the axial dimension of the third electrode 30 may also be greater than 1mm or less than 1mm. The distance between the third electrode 30 and the first electrode 10 and the distance between adjacent ones of the plurality of third electrodes 30 may be adjusted as required.

Referring again to fig. 2, the distal end of the tube 40 is connected to the proximal end of the first electrode 10. The tube body 40 serves as a carrier of the first electrode 10, the second electrode 20 and the at least one third electrode 30, and is delivered to a focal position related to arrhythmia, such as a pulmonary vein, an atrioventricular node, a mitral isthmus, a ventricular outflow tract and other sites needing to be ablated in a point or linear manner, and the first electrode 10, the second electrode 20 and the third electrode 30 ablate target tissues in a focal region by using radio frequency and/or pulse energy, so that the focal is eliminated or isolated.

The pipe body 40 is provided with a wire passage (not shown) for laying a wire. The wires make the first electrode 10, the second electrode 20, and the third electrode 30 electrically conductive with the external pulse generator 220 and the external radio frequency generator 210. The pulse current transmitted from the external pulse generator 220 and the high frequency current transmitted from the external rf generator 210 are transferred to the first electrode 10, the second electrode 20, and the third electrode 30 by wires via the wire path. The number of the wire paths may be one or more. The leads connecting the different electrodes may be provided in one lead path or may be separately provided in different lead paths.

An ablation catheter 100 is described above in connection with the figures. The ablation catheter 100 includes a first electrode 10, at least one second electrode 20, at least one third electrode 30, and a catheter body 40. Wherein the first electrode 10, the at least one second electrode 20 and the at least one third electrode 30 are operable to deliver radiofrequency ablation energy and pulsed ablation energy.

In other embodiments, the ablation catheter 100 may not be provided with the third electrode 30, in which case, the ablation catheter 100 may be subjected to rf ablation by controlling the electrical conduction between one or both of the first electrode 10 and the at least one second electrode 20 and the external rf generator 210; and may be used to pulse ablation with the ablation catheter 100 by controlling electrical communication between one or both of the first electrode 10 and the at least one second electrode 20 and the external pulse generator 220.

When the ablation catheter 100 is provided with only the first electrode 10 and the second electrode 20, the ablation catheter 100 may perform radiofrequency ablation in any one of the following three modes: 1. the first electrode 10 is electrically connected to an external radiofrequency generator 210, the external radiofrequency generator 210 being configured to deliver radiofrequency ablation energy to the first electrode 10 and to at least one back reference electrode (not shown) for monopolar radiofrequency ablation, the back reference electrode being placed on the back of the patient; 2. the at least one second electrode 20 is electrically connected to an external radiofrequency generator 210, the external radiofrequency generator 210 being configured to deliver radiofrequency ablation energy to the at least one second electrode 20 and the at least one back reference electrode for monopolar radiofrequency ablation; 3. the first electrode 10 and the at least one second electrode 20 are each electrically connected to an external radiofrequency generator 210, the external radiofrequency generator 210 being configured to deliver radiofrequency ablation energy to the first electrode 10, the at least one second electrode 20 and the at least one back reference electrode for monopolar radiofrequency ablation.

When the ablation catheter 100 is provided with only the first electrode 10 and the second electrode 20, the pulse ablation performed by the ablation catheter 100 may be any one of the following five modes: 1. the first electrode 10 is electrically connected to an external pulse generator 220, the external pulse generator 220 being adapted to deliver pulse ablation energy to the first electrode 10 and the at least one back reference electrode for monopolar pulse ablation; 2. the at least one second electrode 20 is electrically connected to an external pulse generator 220, the external pulse generator 220 for delivering pulsed ablation energy to the at least one second electrode 20 and the at least one back reference electrode for monopolar pulsed ablation; 3. the first electrode 10 and the at least one second electrode 20 are each electrically connected to an external pulse generator 220, the external pulse generator 220 being adapted to deliver pulse ablation energy to the first electrode 10, the at least one second electrode 20 and the at least one back reference electrode for monopolar pulse ablation; 4. the first electrode 10 and the at least one second electrode 20 are both electrically connected to an external pulse generator 220, the external pulse generator 220 is used for releasing pulse ablation energy to the first electrode 10 and the at least one second electrode 20 for bipolar pulse ablation, and the first electrode 10 and the at least one second electrode 20 are paired in positive and negative electrodes; 5. the at least two second electrodes 20 are electrically connected to an external pulse generator 220, the external pulse generator 220 is configured to release pulse ablation energy to the at least two second electrodes 20 for bipolar pulse ablation, and the at least two second electrodes 20 are paired in a positive and negative polarity.

In contrast to radiofrequency ablation, pulse ablation includes monopolar pulse ablation and bipolar pulse ablation. When the bipolar pulse ablation is performed, the polarity of the positive electrode and the negative electrode of the electrode can be selected, namely the negative electrode and the positive electrode are not fixed one electrode, and the negative electrode can be one or more, and the positive electrode can also be one or more. Compared with unipolar pulse ablation, bipolar pulse ablation has less stimulation on muscles and better ablation effect.

When the ablation catheter 100 is further provided with at least one third electrode 30, the ablation catheter 100 may perform rf ablation by selecting one or more of the first electrode 10, the at least one second electrode 20, and the at least one third electrode 30 to be electrically communicated with the external rf generator 210, so that the ablation catheter 100 performs rf ablation; the pulse ablation performed by the ablation catheter 100 may be selected to provide electrical communication between one or more of the first electrode 10, the at least one second electrode 20, and the at least one third electrode 30 and the external pulse generator 220 to cause the ablation catheter 100 to perform pulse ablation.

Illustratively, during the ablation procedure, during the rf ablation, the first electrode 10 and the at least one third electrode 30 are selected to be electrically connected to the external rf generator 210, the external rf generator 210 is configured to deliver rf ablation energy to the first electrode 10, the at least one third electrode 30 and the at least one back reference electrode for performing monopolar rf ablation; during pulse ablation, at least two second electrodes 20 are selected to be electrically connected to the external pulse generator 220, the external pulse generator 220 is used for releasing pulse ablation energy to the at least two second electrodes 20 so as to perform bipolar pulse ablation, and the at least two second electrodes 20 are paired in positive and negative directions.

In summary, during the ablation process, the ablation catheter 100 may select a suitable electrode for discharging according to the ablation site, and the embodiment of the present application is not limited in particular. The ablation catheter 100 of the present embodiment achieves both radio frequency ablation and pulse ablation through different electrodes, either alone or in combination. In the process of the ablation operation, an operator can select a proper ablation mode according to the actual condition of a patient, the operation is more flexible, and the complexity of the operation is reduced. Meanwhile, the normal tissues of the patient without diseases can be protected as much as possible, and the incidence rate of the postoperative sequelae is reduced. In addition, by acting on the first electrode 10, the second electrode 20, and the third electrode 30 in combination or alone, electric fields covering regions of different sizes can be formed. For example, the first electrode 10 and the third electrode 30 may form a local pulse electric field around the tip of the tube 40 after being connected to the external pulse generator 220. The two second electrodes 20 may form a local pulse electric field smaller than the first electrode 10 after being connected to the external pulse generator 220.

In one embodiment, the ablation catheter 100 further includes a temperature sensor (not shown). Schematically, the thermoreceptors are arranged within the first electrode 10 and are insulated from the first electrode 10. The temperature sensor is used for monitoring the temperature of target tissues and/or the temperature of the first electrode 10 in the process of radio frequency ablation or pulse ablation in real time, so that eschar or heart tissue damage caused by overhigh temperature is prevented, and the safety of an ablation operation is improved. The number of the temperature sensors can be one or more.

In other embodiments, the temperature sensor may be disposed within the second electrode 20 and insulated from the second electrode 20. The wire connecting the temperature susceptor may be in the same wire path as the wire connecting the first electrode 10 or the second electrode 20. It is of course also possible to provide additional conduits inside the tubular body 40 for laying the wires electrically connected to the temperature sensor.

In another example of the present application, one or more of the first electrode 10, the at least one second electrode 20, and the at least one third electrode 30 may also be used for potential mapping. In the present embodiment, the first electrode 10, the second electrode 20, and the third electrode 30 may all be used for potential mapping.

In one embodiment, the second electrode 20 may also be used to measure the local impedance value of the target tissue when the number of second electrodes 20 is greater than two. When the second electrodes 20 contact the target tissue, any two second electrodes 20 may measure a local impedance value of the local target tissue between the two second electrodes 20.

The local impedance value between the two second electrodes 20 monitored by the external device can be used to determine the degree of apposition of the second electrodes 20 and to assess the ablation lesion. The impedance magnitude and the fitting degree are in positive correlation: good adhesion, large impedance, poor adhesion and small impedance. During the ablation, the change of the local impedance value can also reflect the situation of an ablation lesion in the tissue, for example, the average value of the local impedances measured between two second electrodes 211 of the three second electrodes 211 in the first ring 21 is used as the local impedance value to evaluate the ablation lesion at the position of the first ring 21. The magnitude of the change in the local impedance value may reflect the size of the ablation lesion (i.e., the ablation depth), and the rule is: the larger the impedance change degree before and after ablation, the deeper the ablation depth is.

Example two

Referring to fig. 7, fig. 7 is a schematic structural diagram of an ablation catheter 100 according to a second embodiment of the present application. The ablation catheter 100 of the present embodiment includes a first electrode 10, a second electrode 20, at least one third electrode 30, and a catheter body 40. The proximal end of the first electrode 10 is connected to the distal end of the tube 40, the second electrode 20 is disposed in the first electrode 10 and insulated from the first electrode 10, and at least one third electrode 30 is disposed on the outer wall of the tube 40.

The structural forms of the first electrode 10, the second electrode 20, the at least one third electrode 30 and the catheter body 40 in the second embodiment are the same as those in the first embodiment, and the modes of performing radio frequency and pulse ablation on the first electrode 10, the second electrode 20 and the at least one third electrode 30 independently or in a combined manner are not repeated herein.

The ablation catheter 100 of the second embodiment differs from the ablation catheter 100 of the first embodiment mainly in that: the ablation catheter 100 of this embodiment adds an infusion hole 50 to the first electrode 10. The infusion orifice 50 is spaced from the second electrode 20. The present embodiment does not particularly limit the relative positions of the infusion hole 50 and the second electrode 20 as long as the two do not interfere with each other.

The first electrode 10 is provided with a perfusion channel (not shown) inside, and the perfusion hole 50 is communicated with the perfusion channel and the outer surface of the first electrode 10. The perfusion channel is used for conveying a cooling medium 51, the perfusion holes 50 are used for releasing the cooling medium 51, and the cooling medium 51 is used for cooling the target tissue and the first electrode 10. The tube body 40 is also provided with a channel for transporting a cooling medium, the channel is communicated with the perfusion channel inside the first electrode 10, and an external cooling medium can be conveyed to the perfusion channel of the first electrode 10 through the channel inside the tube body 40, and finally, the target tissue and the first electrode 10 are cooled through the perfusion hole 50.

The specific number and arrangement of the infusion holes 50 in this embodiment are not limited. During ablation, the cooling medium 51 may be cold saline or other substance.

It can be understood that the irrigation holes 50 and the irrigation channels are provided in the ablation catheter 100, so that the cooling medium 51 can be released during the ablation procedure to cool the target tissue or cool the electrode at the head of the catheter, so as to more accurately control the temperature of the target tissue or the temperature of the first electrode 10, reduce the risk of eschar, thrombus and myocardial tissue damage, and improve the safety of the procedure.

EXAMPLE III

Referring to fig. 8, fig. 8 is a schematic structural diagram of an ablation catheter 100 according to a third embodiment of the present application. The ablation catheter 100 of the present embodiment includes a first electrode 10, a second electrode 20, at least one third electrode 30, and a catheter body 40. The proximal end of the first electrode 10 is connected to the distal end of the tube 40, the second electrode 20 is disposed in the first electrode 10 and insulated from the first electrode 10, and at least one third electrode 30 is disposed on the outer wall of the tube 40.

The structural forms of the first electrode 10, the second electrode 20, the at least one third electrode 30 and the catheter body 40 in the third embodiment, and the ways of performing radio frequency and pulse ablation on the first electrode 10, the second electrode 20 and the at least one third electrode 30 individually or in a combined manner are the same as those in the first embodiment, and are not described herein again.

The ablation catheter 100 of the third embodiment differs from the ablation catheter 100 of the first embodiment mainly in that: the body 40 of the ablation catheter 100 of this embodiment is provided with a deformation portion on which at least one positioning electrode 60 is disposed. At least one reference electrode 70 is also provided on the outer wall of the tube 40.

The deformation position of body 40 is located the distal end of body 40, and the deformation that the deformation portion can be followed to the distal end of body 40 takes place deformation. This application does not add the restriction to the structure of deformation portion, should know can give the good deformability of deformation portion through multiple means. For example, the deformation portion is made of a polymer material such as plastic or rubber having elasticity, or is made of a metal material having a shape memory function. Metallic materials for shape memory function include, but are not limited to, nitinol.

The at least one third electrode 30 and the at least one positioning electrode 60 are sequentially spaced from the distal end to the proximal end in the axial direction of the tubular body 40. The number of the positioning electrodes 60 may be one or multiple, and in this embodiment, the ablation catheter 100 includes two positioning electrodes 60, which are a first positioning electrode 61 and a second positioning electrode 62, respectively, and the first positioning electrode 61 and the second positioning electrode 62 are sequentially spaced from the distal end to the proximal end along the axial direction of the catheter body 40.

In this embodiment, the first positioning electrode 61 and the second positioning electrode 62 are annular and are sleeved on the outer wall of the tube 40. In other embodiments, the first positioning electrode 61 and the second positioning electrode 62 may have other shapes. The axial dimensions of the first positioning electrode 61 and the second positioning electrode 62 are both 1mm.

The third electrode 33 is spaced from the first positioning electrode 61 by a distance in the range of 20mm to 40mm in the axial direction of the tubular body 40. The spacing between the first positioning electrode 61 and the second positioning electrode 62 is in the range of 20mm to 40 mm. Note that the pitch here is the pitch between adjacent end faces of different electrodes. In the present embodiment, the third electrode 33 is spaced from the first positioning electrode 61 by 31mm along the axial direction of the tube 40. The distance between the first positioning electrode 61 and the second positioning electrode 62 is 23mm.

At least one positioning electrode 60 is disposed on the deformation portion, and the at least one positioning electrode 60 is used for determining whether the distal end of the tube 40 is deformed and the degree of deformation. The method for determining whether the distal end of the tube 40 is deformed and the degree of deformation is as follows:

the first electrode 10, the at least one third electrode 30 and the at least one positioning electrode 60 emit electric field signals with certain frequency, and the electric field signals can be captured by corresponding equipment, lock the electrode position and further can be used for judging the position of the electrode in the body.

When the connecting line among the spatial positions of the first electrode 10, the at least one third electrode 30 and the at least one positioning electrode 60 is parallel to the axial lead of the tube 40 at the proximal end, it is determined that the distal end of the tube 40 is not deformed; when the connection line among the spatial positions of the first electrode 10, the at least one third electrode 30, and the at least one positioning electrode 60 intersects with the axis of the tube 40 located at the proximal end, it is determined that the distal end of the tube 40 is deformed, and the spatial positions of the three can be used to determine the degree of deformation of the distal end of the tube 40. Specifically, the spatial positions of the first electrode 10, the at least one third electrode 30, and the at least one positioning electrode 60 may be connected by a software algorithm, and then the degree of deformation occurring at the distal end of the tubular body 40 may be calculated therefrom.

In the present embodiment, when the connection line between the spatial positions of the first electrode 10, the third electrode 31, the third electrode 32, the third electrode 33, the first positioning electrode 61, and the second positioning electrode 62 is parallel to the axial line of the tube 40 located at the proximal end, it is determined that the distal end of the tube 40 is not deformed. When the connecting lines between the spatial positions of the first electrode 10, the third electrode 31, the third electrode 32, the third electrode 33, the first positioning electrode 61, and the second positioning electrode 62 intersect with the axial line of the tube 40 located at the proximal end, it is determined that the distal end of the tube 40 is deformed.

In addition, when the distal end of the tube 40 is deformed, the spatial positions of the first electrode 10, the third electrode 31, the third electrode 32, the third electrode 33, the first positioning electrode 61 and the second positioning electrode 62 can be connected by a software algorithm, and then the degree of deformation of the distal end of the tube 40 can be calculated accordingly. It will be appreciated that the greater the number of third electrodes 30 and position electrodes 60, the closer the calculation result of the degree of deformation will be to the true degree of deformation.

The outer wall of the tube 40 is also provided with at least one reference electrode 70. The number of the reference electrodes 70 may be one or plural. In this embodiment, the number of the reference electrodes 70 is one, but in other embodiments, the number of the reference electrodes 70 may be plural.

The reference electrode 70 serves as a reference point in the potentiometric measurement. Specifically, in the process of mapping the intracardiac signals, when the first electrode 10, the second electrode 20 and the third electrode 30 are selected to map the intracardiac unipolar signals, a reference zero point needs to be set, and the reference zero point can be selected as a Wilson central point on the body surface of the patient or can be selected as an intracavitary unipolar reference electrode from any electrode except the heart in the body. The advantage of the intracavity unipolar reference electrode is that electrocardiosignals recorded by other mapping electrodes are stable and clear, and interference signals are few. Reference electrode 70 functions here as an intracardiac unipolar reference electrode.

In this embodiment, the reference electrode 70 is annular and is disposed on the outer wall of the tube 40. In other embodiments, the reference electrode 70 may have other shapes. The axial dimension of the reference electrode 70 is 1mm. In the present embodiment, the third electrode 30, the positioning electrode 60 and the reference electrode 70 are all configured to have the same shape and size, which is convenient for manufacturing and installation.

The second registration electrode 62 is spaced from the reference electrode 70 by a distance in the range of 15cm to 25cm in the axial direction of the tubular body 40. Note that, the pitch here is the pitch between the adjacent end faces of the different electrodes. In this embodiment, the second positioning electrode 62 is spaced from the reference electrode 70 by 18cm along the axial direction of the tubular body 40.

In one embodiment, the ablation catheter 100 of the present embodiment may not include the positioning electrode 60.

In one embodiment, the ablation catheter 100 of the present embodiment may not include the reference electrode 70.

In one embodiment, the ablation catheter 100 structure of example two can also be combined with the ablation catheter 100 structure of example three, i.e., the ablation catheter 100 includes a first electrode 10, a second electrode 20, at least one third electrode 30, a tube 40, at least one positioning electrode 60, and at least one reference electrode 70. Wherein the first electrode 10 is provided with an injection hole 50 for releasing a cooling medium 51.

In the present application, the structure of three ablation catheters 100 is specifically described by referring to the associated drawings. As can be appreciated, the present application provides an ablation catheter 100, the ablation catheter 100 including a catheter body 40, a first electrode 10, and a second electrode 20. By controlling the electrical conduction state of the first electrode 10 and the second electrode 20, the ablation catheter 100 can be switched between a radio frequency ablation mode in which the ablation catheter 100 performs radio frequency ablation and a pulse ablation mode in which the ablation catheter 100 performs pulse ablation. Thus, during an ablation procedure, a suitable energy output can be selected for discharge based on the ablation site, and the ablation catheter 100 can use both radiofrequency energy ablation and pulsed electric field ablation. That is, some electrodes on the ablation catheter 100 can receive the pulse current to achieve the purpose of pulse ablation, and some electrodes can receive the radio frequency current to achieve the purpose of radio frequency ablation. Therefore, the ablation catheter 100 of the embodiment can realize free switching of energy in the ablation process, that is, in the ablation process, an operator can select a more suitable energy mode to perform ablation according to the complexity of a surgical site, the actual condition of a patient or the surgical experience, so that the flexibility of the ablation process is improved, the complexity of the surgery is greatly reduced, the operability of the surgery is increased, the surgery time is effectively shortened, and the risk in the surgery process is reduced.

The above description is only an embodiment of the present application, but the scope of the present application is not limited thereto, and any person skilled in the art can easily think of the changes or substitutions within the technical scope of the present application, and the changes or substitutions should be covered within the scope of the present application; the embodiments and features of the embodiments of the present application may be combined with each other without conflict. Therefore, the protection scope of the present application shall be subject to the protection scope of the claims.

Claims

1. An ablation catheter, comprising:

a tube body;

the proximal end of the first electrode is connected with the distal end of the tube body;

the second electrode is arranged in the first electrode and is insulated from the first electrode;

controlling the electrical conduction state of the first electrode and the second electrode to enable the ablation catheter to switch between a radio frequency ablation mode and a pulse ablation mode, wherein in the radio frequency ablation mode, the ablation catheter carries out radio frequency ablation, and in the pulse ablation mode, the ablation catheter carries out pulse ablation.

2. The ablation catheter of claim 1, wherein the second electrode is provided in a plurality, the second electrode being provided within the first electrode, the second electrodes being arranged circumferentially about an axial centerline of the first electrode.

3. The ablation catheter of claim 2, wherein the plurality of second electrodes define a ring shape in a circumferential direction of the first electrode, and a plane of the plurality of second electrodes in the ring shape is perpendicular to an axial line of the first electrode.

4. The ablation catheter of claim 3, wherein the first electrode has a plurality of said rings spaced axially thereon, each of said rings including a plurality of said second electrodes circumferentially arranged about an axial centerline of the first electrode.

5. The ablation catheter according to claim 4, wherein any one of the second electrodes included in one of the two adjacent rings is offset from any one of the second electrodes included in the other ring in a circumferential direction of the first electrode.

6. The ablation catheter of claim 5, wherein each of said rings includes a plurality of said second electrodes evenly spaced circumferentially about an axial centerline of said first electrode.

7. The ablation catheter of any one of claims 1-6, wherein the ablation catheter is radio frequency ablated by controlling electrical communication between one or both of the first electrode and at least one of the second electrodes and an external radio frequency generator;

the ablation catheter is pulsed by controlling electrical communication between one or both of the first and at least one of the second electrodes and an external pulse generator.

8. The ablation catheter of claim 7, wherein the first electrode is electrically connected to the external radiofrequency generator for radiofrequency ablation, the external radiofrequency generator being configured to deliver radiofrequency ablation energy to the first electrode and at least one back reference electrode for monopolar radiofrequency ablation; alternatively, the first and second liquid crystal display panels may be,

at least one of the second electrodes is electrically connected to the external radiofrequency generator for delivering radiofrequency ablation energy to at least one of the second electrodes and at least one of the back reference electrodes for monopolar radiofrequency ablation; alternatively, the first and second electrodes may be,

the first electrode and at least one of the second electrodes are electrically connected to the external radiofrequency generator for delivering radiofrequency ablation energy to the first electrode, at least one of the second electrodes and at least one of the back reference electrodes for monopolar radiofrequency ablation.

9. The ablation catheter of claim 7, wherein the first electrode is electrically connected to the external pulse generator for delivering pulse ablation energy to the first electrode and at least one back reference electrode for monopolar pulse ablation when the ablation catheter is performing pulse ablation; alternatively, the first and second liquid crystal display panels may be,

at least one of the second electrodes is electrically connected to the external pulse generator for delivering pulse ablation energy to at least one of the second electrodes and at least one of the back reference electrodes for monopolar pulse ablation; alternatively, the first and second liquid crystal display panels may be,

the first electrode and at least one of the second electrodes are each electrically connected to the external pulse generator for delivering pulse ablation energy to the first electrode, at least one of the second electrodes, and at least one of the back reference electrodes for monopolar pulse ablation; alternatively, the first and second liquid crystal display panels may be,

the first electrode and at least one of the second electrodes are each electrically connected to the external pulse generator for delivering pulsed ablation energy to the first electrode and at least one of the second electrodes for bipolar pulsed ablation; alternatively, the first and second electrodes may be,

at least two of the second electrodes are each electrically connected to the external pulse generator for delivering pulse ablation energy to at least two of the second electrodes for bipolar pulse ablation.

10. The ablation catheter of any one of claims 1-6 further comprising at least one third electrode disposed on an outer wall of said tubular body, said ablation catheter being switched between said radiofrequency ablation mode and said pulse ablation mode by controlling an electrical conduction state of said first electrode, at least one of said second electrodes, and at least one of said third electrodes.

11. The ablation catheter of claim 10, wherein the ablation catheter is radio frequency ablated by controlling electrical communication between one or more of the first electrode, at least one of the second electrode, and at least one of the third electrode and an external radio frequency generator;

controlling electrical communication between one or more of the first electrode, at least one of the second electrode, and at least one of the third electrode and an external pulse generator to cause the ablation catheter to perform pulse ablation.

12. The ablation catheter of claim 11, wherein the tube has a shape-changing portion at a distal end thereof, the distal end being deformable following the shape-changing portion;

the ablation catheter further comprises at least one positioning electrode arranged on the outer wall of the catheter body, at least one positioning electrode is arranged on the deformation part, and at least one positioning electrode is used for judging whether the far end of the catheter body deforms or not and the deformation degree.

13. The ablation catheter of claim 12, wherein at least one of the third electrodes and at least one of the positioning electrodes are spaced apart in sequence from the distal end to the proximal end along the axial direction of the catheter body;

when a connecting line among the spatial positions of the first electrode, the at least one third electrode and the at least one positioning electrode is parallel to the axial lead of the tube body positioned at the near end, the far end of the tube body is not deformed;

when the connecting line among the spatial positions of the first electrode, the at least one third electrode and the at least one positioning electrode intersects with the axial lead of the tube body positioned at the near end, the far end of the tube body deforms, and the spatial positions of the first electrode, the at least one third electrode and the at least one positioning electrode can be used for judging the degree of deformation of the far end of the tube body.

14. The ablation catheter of claim 10, wherein one or more of the first electrode, at least one of the second electrodes, and at least one of the third electrodes are also used for potential mapping.

15. The ablation catheter of claim 14 further comprising at least one reference electrode disposed on an outer wall of said catheter body, at least one of said reference electrodes serving as a reference point for electrical potential calibration.

16. The ablation catheter of any of claims 1-6, wherein a temperature receptor is disposed within the first electrode, the temperature receptor being configured to monitor the temperature of the target tissue and/or the temperature of the first electrode in real time.

17. The ablation catheter of any one of claims 1-6, wherein an irrigation hole is further formed in the first electrode, the irrigation hole is spaced from the second electrode, an irrigation channel is formed in the first electrode, and the irrigation hole is communicated with the irrigation channel and the outer surface of the first electrode;

the perfusion channel is used for conveying a cooling medium, the perfusion hole is used for releasing the cooling medium, and the cooling medium is used for cooling the target tissue and the first electrode.

18. The ablation catheter of claim 1, wherein a side of the first electrode is provided with a mounting hole for mounting the second electrode.

19. An ablation system comprising an ablation catheter according to any of claims 1 to 18 and an energy output device for selectively outputting radiofrequency ablation energy and pulsed ablation energy to the ablation catheter.