CN112914721A

CN112914721A - Electrode device, medical catheter and ablation system

Info

Publication number: CN112914721A
Application number: CN202110310411.0A
Authority: CN
Inventors: 沈磊; 刘梦瑶; 梁波; 孙毅勇
Original assignee: Shanghai Microport EP MedTech Co Ltd
Current assignee: Shanghai Microport EP MedTech Co Ltd
Priority date: 2021-03-23
Filing date: 2021-03-23
Publication date: 2021-06-08

Abstract

The present invention relates to an electrode device, a medical catheter and an ablation system; the ablation system comprises a medical catheter and an energy output device for outputting ablation energy to the medical catheter; the medical catheter comprises an electrode arrangement; the electrode device comprises a head electrode group, the head electrode group comprises at least two head electrodes which are distributed circumferentially, the at least two head electrodes are connected through a first insulator, and the electrode device is configured that any cross section contains the cross section of the at least two head electrodes; thereby enabling more accurate and comprehensive ablation or mapping.

Description

Electrode device, medical catheter and ablation system

Technical Field

The invention relates to the technical field of medical instruments, in particular to an electrode device, a medical catheter and an ablation system.

Background

Tissue ablation is a treatment commonly used to treat disorders such as cardiac arrhythmias, including atrial fibrillation. Abnormal electrical propagation to ablate myocardial tissue and/or ablation interrupts abnormal electrical conduction to repair tissue. Radio frequency ablation is a common mode currently used clinically for treating arrhythmia such as atrial fibrillation. The rf ablation is to release rf current to cause coagulation necrosis of local endocardium and endocardium myocardium, and achieve ablation effect in the form of heat release, but it has certain limitations, lacks selectivity for damage to tissue in the ablation area, and depends on the adhesion force of the catheter, so it may cause damage to the adjacent esophagus, coronary artery, and phrenic nerve.

With the development of pulse technology, pulsed electric fields are used as an efficient and safe ablation energy for treating cardiac ablation. Unlike radiofrequency ablation, microsecond pulses are a non-thermal biological effect on irreversible electroporation damage of myocardial cell membranes, and can effectively avoid injury of blood vessels, nerves and esophagus. The existing cardiac ablation field mostly adopts single energy ablation technologies such as radio frequency and pulsed electric field, and cannot flexibly make up for deficiencies. Radio frequency ablation, which is precipitated for many years, has a mature ablation technology on one hand and rich radio frequency ablation experience of doctors on the other hand. Compared with radio frequency ablation, the pulse technology is in a development stage, and the selection characteristic of the pulse technology to the tissues can make up the deficiency of the radio frequency ablation to a great extent.

However, none of the existing ablation catheters, such as the PFA ablation catheter (PFA is pulsed field ablation) or the rf ablation catheter, is compatible with both rf ablation and pulsed electric field ablation, and the ablation mode is single, which reduces the flexibility of the operation and also increases the complexity of the operation. In addition, the conventional PFA ablation catheter cannot be well attached to tissues, so that the tissues are easily ablated insufficiently, a plurality of electrodes cannot be attached to target tissues simultaneously in the whole ablation process, the ablation energy field cannot be guaranteed to cover the target tissues in a concentrated manner, and the ablation effect is influenced. In addition, the existing ablation catheter cannot perform effective mapping on the arrhythmia part, and the mapping precision is low.

Disclosure of Invention

In order to solve at least one of the above technical problems, it is an object of the present invention to provide an electrode device, a medical catheter and an ablation system, which at least solve the problems that the ablation energy field, especially the pulse electric field, cannot be concentrated to cover the target tissue, so that the target tissue is not completely ablated or the potential mapping is not accurate.

In order to achieve the above object, according to a first aspect of the present invention, there is provided an electrode device including a head electrode group including at least two head electrodes circumferentially distributed, at least two of the head electrodes being connected by a first insulator, and the electrode device being configured such that any one cross section includes a cross section of at least two of the head electrodes.

Optionally, at least two of the head electrodes are uniformly arranged in the circumferential direction of the first insulator.

Optionally, at least two of the head electrodes are connected to the first insulator in an injection molding manner, or at least two of the head electrodes are connected to the first insulator in a snap-fit and/or press-fit manner.

Optionally, the first insulator has at least two circumferentially distributed assembly grooves, and one of the head electrodes is mounted in each assembly groove;

one of the first insulator and the head electrode is provided with a buckle, and the other is provided with a clamping groove, and the buckle is connected with the clamping groove in a matched manner; and/or at least part of the inner edge of any one of the head electrodes is in concave-convex fit connection with the side wall of the assembly groove.

Optionally, a buckle is arranged on the assembling groove of the first insulator, a clamping groove is arranged on the inner side surface of the head electrode, and the buckle and the clamping groove are both arc-shaped.

Optionally, the electrode device further comprises a perfusion channel and a perfusion hole, and the perfusion hole is formed in the side surface of the electrode device and communicated with the perfusion channel; and a lead passage is arranged on the inner side surface of each head electrode, and the perfusion channel is separated from the lead passage through the first insulator.

Optionally, the electrode device further comprises at least one microelectrode, at least one microelectrode is used for detecting electrocardiosignals and/or temperature, and the microelectrode and the head electrode group are insulated from each other;

the side surface of each head electrode is provided with a through mounting hole, and the mounting hole is used for mounting the microelectrode; a lead passage is arranged on the inner side surface of each head electrode and is communicated with the mounting hole; and a temperature sensor is arranged in the microelectrode and used for sensing the temperature of the tissue or the head electrode.

Optionally, the first insulator includes a hollow rod-shaped body and a jaw, and the jaw has at least two clamping arms; the clamping jaws are arranged on the rod-shaped body and are coaxially arranged, each clamping arm is fixedly connected with the rod-shaped body, and one head electrode is arranged between the two clamping arms; the proximal end of the rod-shaped body is provided with threads.

Optionally, the number of the head electrodes is two, and the insulation distance between two head electrodes is 0.15mm to 1.5mm, or the number of the head electrodes is at least three, and the insulation distance between any two adjacent head electrodes in the at least three head electrodes is 0.15mm to 1.5 mm.

Optionally, the electrode means has a smooth outer surface and/or rounded corners are formed between the distal and side surfaces of the electrode means.

Optionally, the number of the head electrodes is 3, and any longitudinal section of the electrode device comprises at least one section of the head electrode.

In order to achieve the above object, according to a second aspect of the present invention, there is provided a medical catheter comprising a catheter body including a catheter tip, the catheter tip being provided with any one of the electrode devices.

Optionally, the catheter tip further comprises an elastic tube body and at least one strain gauge, and the at least one strain gauge is disposed on the elastic tube body; the electrode device is connected with the elastic tube body and is coaxially arranged; and/or the catheter tip further comprises a ring electrode set comprising at least one ring electrode mounted on the catheter body, and the head electrode and the ring electrode are insulated from each other by a second insulator; the ring electrode is used for potential mapping or is used for being matched with the head electrode to release ablation energy.

To achieve the above object, according to a third aspect of the present invention, there is provided an ablation system comprising the medical catheter and an energy output device for selectively outputting ablation energy to the medical catheter, the ablation energy comprising pulsed ablation and/or radiofrequency ablation energy.

Optionally, the ablation system has the following ablation modes:

the energy output device is configured for simultaneously delivering ablation energy to at least one of the head electrode and at least one reference electrode to form a monopolar ablation; and/or the presence of a gas in the gas,

the energy output device is configured for releasing ablation energy to at least two of the head electrodes simultaneously or to at least one of the head electrodes and at least one of the ring electrodes simultaneously to form a bipolar ablation.

The electrode device, the medical catheter and the ablation system provided by the invention have the following advantages:

first, any cross section of the electrode device comprises a section of at least two head electrodes, so that when the electrode device is attached to the target tissue, the head of the electrode device can simultaneously attach the at least two head electrodes to the target tissue at any time and at any position, or the side surfaces of the electrode device can simultaneously attach the at least two head electrodes to the target tissue at some positions, so that energy is concentrated in the target tissue rather than blood, ablation of the target tissue is more thorough, or electric potential mapping is more accurate;

secondly, after the electrode device is applied to the medical catheter, energy selection in an ablation process can be realized, such as radio frequency ablation or pulse ablation, namely, in the ablation process, an operator can select a more appropriate energy mode to perform ablation according to the complexity of an operation part, the actual condition of a patient or the experience of a doctor, so that the flexibility of the ablation process is improved, the complexity of an operation is greatly reduced, the operability of the operation is increased, the operation time is effectively shortened, and the risk in the operation process is reduced;

thirdly, after the medical catheter is applied to the electrode device, a proper electrode can be selected according to an ablation part, for example, at least one head electrode and at least one reference electrode form unipolar radio frequency ablation or unipolar pulsed electric field ablation, or at least one head electrode and at least one ring electrode form bipolar pulsed electric field ablation, or a plurality of head electrodes (a plurality of which include two) form bipolar pulsed electric field ablation, so that the operation is more flexible and convenient, the simultaneous attachment of the plurality of head electrodes to a target tissue is facilitated, more accurate and comprehensive ablation is achieved, unnecessary injuries are reduced, and the ablation safety is improved;

fourthly, at least part of the inner edge of the head electrode in the electrode device is in concave-convex fit connection with the groove wall of the assembly groove of the first insulator, so that the connectivity of the head electrode and the first insulator is increased, the structure of the electrode device is more stable, and the head electrode can be effectively prevented from falling off; in addition, one of the first insulator and the head electrode is provided with a buckle, and the other is provided with a clamping groove, and the buckle is connected with the clamping groove in a matched manner, so that the connection stability of the electrode device and the medical catheter body is further enhanced; particularly, the first insulator is provided with threads to be connected with the tube body of the medical catheter, so that the connection strength can be enhanced, and the electrode can be effectively prevented from falling off.

Drawings

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

FIG. 1 is a schematic view of a medical catheter in a preferred embodiment of the invention;

FIG. 2a is an enlarged view of the catheter tip shown in FIG. 1;

FIG. 2B is a cross-sectional view of the catheter tip shown in FIG. 2a taken along line B-B;

FIG. 2c is an enlarged partial view of the catheter tip shown in FIG. 2b at position A;

FIG. 2D is a cross-sectional view of the catheter tip shown in FIG. 2b taken along line D-D;

FIG. 3a is a perspective view of a catheter tip in a preferred embodiment of the invention;

FIG. 3b is an enlarged partial view of the catheter tip shown in FIG. 3a at position E;

FIG. 4a is a schematic view of the internal structure of the head electrode group in the preferred embodiment of the present invention, in which a partial schematic view of a lead path is shown;

FIG. 4B is a cross-sectional view of the head electrode assembly shown in FIG. 4a taken along line B-B;

FIG. 5a is a schematic end view of an arrangement of three head electrodes in a preferred embodiment of the present invention;

FIG. 5b is a schematic perspective view of a three head electrode arrangement in a preferred embodiment of the invention;

FIG. 5c is a schematic end view of the first insulator in a preferred embodiment of the invention;

FIG. 5d is a perspective view of the first insulator in the preferred embodiment of the present invention;

FIG. 6a is a schematic diagram of the electric field formed by two head electrodes in a preferred embodiment of the present invention;

FIG. 6b is a schematic diagram of the electric fields formed by the three head electrodes in the preferred embodiment of the present invention;

fig. 6c is a schematic diagram of the electric field formed by four head electrodes in the preferred embodiment of the present invention.

The reference numerals are explained below:

100-a catheter tip; 1-head electrode group; 1-a first head electrode; 1-B-a second head electrode; 1-C-third head electrode; 1-D-card slot; 1-E-groove; 1-F-conductor path; 2-microelectrodes; 3-1-a first insulator; 3-2-a second insulator; 3-3-assembling a groove; 3-4-buckling; 31-a rod-shaped body; 32-jaws; 33-a clamp arm; 4-a perfusion hole; 41-perfusion channel; 101-ring electrode set; 5-a first ring electrode; 6-a second ring electrode; 7-a third ring electrode; 8-a pipe body; 102-a handle assembly; 10-controlling the bending pushing piece; 11-a handle; 12-a signal port; 13-an energy port; 14-cooling medium pouring opening; 15-a wire; 16-an elastic tube body; 17-inner tube.

Detailed Description

In order to make the content of the present invention more comprehensible, the present invention is further described with reference to the accompanying drawings. The invention is of course not limited to this particular embodiment, and general alternatives known to those skilled in the art are also covered by the scope of the invention. The present invention is described in detail with reference to the drawings, but these drawings are only for convenience of describing the present invention in detail and should not be construed as limiting the present invention.

Furthermore, each of the embodiments described below has one or more technical features, which, however, does not mean that all of the technical features of any one embodiment must be implemented simultaneously by the inventor or that only one or all of the technical features of different embodiments can be implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.

Herein, "proximal" and "distal" are relative orientations, relative positions, directions of elements or actions with respect to each other from the perspective of a physician using the product, although "proximal" and "distal" are not limiting, but "proximal" generally refers to the end of the product that is closer to the physician during normal operation, while "distal" or "head end" or "head" generally refers to the end that is first introduced into the patient. As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the plural form "a plurality" includes at least two. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. Furthermore, the term "circumferential" generally refers to a direction about the axis of the medical catheter; the term "longitudinal" generally refers to a direction parallel to the axis of a medical catheter; the term "transverse" generally refers to a direction perpendicular to the axis of the medical catheter.

An object of the present invention is to provide an electrode device including a head electrode group including at least two head electrodes circumferentially distributed and connected to be insulated from each other by a first insulator, and configured such that any one cross section includes a cross section of at least two of the head electrodes. So constructed, when the electrode device is contacted with the target tissue, if the electrode device is contacted with the target tissue by the head or contacted with the target tissue by the side surface, the head and some side surfaces can realize that at least two head electrodes are simultaneously attached to the target tissue, thereby enabling the released energy, especially the pulse electric field, to cover the target tissue but not blood as much as possible, achieving more accurate ablation or more accurate electric potential mapping, enabling the target tissue to be ablated more thoroughly or enabling the electric potential mapping to be more accurate. Therefore, the head electrode is not limited to an ablation electrode, and may be a mapping electrode.

Preferably, the number of the head electrodes is 3 or more (i.e., includes 3 or more), and more preferably, a plurality of head electrodes are uniformly distributed along the circumferential direction of the first insulator.

It is another object of the present invention to provide a medical catheter, which may be an ablation catheter or a mapping catheter. Specifically, the medical catheter comprises a catheter body, wherein the catheter body comprises a catheter tip, and the catheter tip is provided with the electrode device. When the electrode device is used for ablation, the medical catheter can use radio frequency energy for ablation and can also use a pulse electric field for ablation, namely, the head electrode can receive pulse current to achieve the purpose of pulse ablation and can also receive high-frequency current to achieve the purpose of radio frequency ablation. Therefore, the medical catheter can realize the selection of energy in the ablation process, namely, in the ablation process, an operator can select a more suitable energy mode to perform ablation according to the complexity of a surgical part, the actual condition of a patient or the experience of a doctor, so that the flexibility of the ablation process is improved, the complexity of the operation is greatly reduced, the operability of the operation is improved, the operation time is effectively shortened, and the risk in the operation process is reduced. More specifically, during the radio frequency ablation, at least one head electrode and at least one reference electrode are selected to be electrically conducted to receive high-frequency current, so that monopolar radio frequency ablation is formed; monopolar ablation with a pulsed electric field, similar to radiofrequency ablation, also requires electrical communication between at least one head electrode and at least one reference electrode to receive electrical pulses, resulting in monopolar pulsed electric field ablation. It should be understood that in monopolar ablation, the number of head electrodes may be one or more, and the polarity of the plurality of head electrodes is the same. Furthermore, the pulsed electric field may also be bipolar ablation: selectively electrically conducting the at least one head electrode and the at least one ring electrode to receive electrical pulses, the at least one head electrode and the at least one ring electrode being of opposite polarity; alternatively, at least two of the head electrodes may be selectively electrically conducted to receive the electrical pulses, and the polarity of at least two of the head electrodes may be reversed. It should be understood that in bipolar ablation, the polarity of the positive and negative electrodes of the electrode can be selected, i.e. the negative electrode and the positive electrode are not fixed certain head electrode or certain ring electrode, and the negative electrode can be one or more, and the positive electrode can also be one or more.

It should also be understood that the medical catheter of the present invention is not limited to cardiac ablation, but may be used for ablation of different sites or diseases such as renal artery ablation, bronchial ablation, etc., and the present application is not limited thereto. Then, in the whole ablation process, when the catheter head end is in contact with the target tissue, at least the far end of the catheter head end can realize that the plurality of head electrodes are attached to the target tissue at any time, so that ablation energy (such as a pulse electric field) covers the target tissue rather than blood as much as possible, a better ablation effect is achieved, unnecessary injuries are reduced, or a better potential mapping effect is obtained.

Further, the catheter head end further comprises an elastic tube body and at least one strain gauge, the at least one strain gauge is arranged on the elastic tube body, and the electrode device is connected with the elastic tube body and coaxially arranged. In this case, the medical catheter is provided with a pressure sensor at the distal end, which monitors the force applied to the distal end of the catheter. The structure of the elastic tube body is not limited in the present invention, and it is understood that the elastic tube body can be endowed with excellent elasticity by various means, such as a plastic tube or a rubber tube (polymer material) having elasticity or a metal tube, and the metal tube is preferably made of a metal material having a shape memory function, including but not limited to nitinol. The strain gauges are preferably three strain gauges, and at least three strain gauges are uniformly arranged in the circumferential direction of the elastic tube body. The strain gauge may be a conventional single-bridge strain gauge or a half-bridge strain gauge, or may be an unconventional strain gauge such as a shear gauge or a strain gauge, and the strain gauge of the corresponding type is selected mainly according to the structure of the elastic tube body, and is not particularly limited. Therefore, when the electrode device is contacted with the vessel wall or the tissue surface, the head end of the catheter can carry out tissue ablation or potential mapping through the head electrode, and can also obtain the magnitude and the direction of the contact force when the head end of the catheter is contacted with the tissue, and after the elastic tube body is subjected to the contact force, the electric signal of the pressure sensor changes, and the magnitude and the direction of the contact force can be obtained according to the changed electric signal. That is, the strain gauge senses the deformation of the elastic tube body to output a varying electrical signal.

It is a further object of the present invention to provide an ablation system comprising the medical catheter of the present invention and further comprising an energy output device, which may be a radiofrequency instrument and/or a pulse generator. The energy output device is used for selectively outputting ablation energy to the medical catheter. For example, when the energy output device is a radiofrequency device, high frequency current is sent to the medical catheter to achieve radiofrequency ablation; when the energy output device is a pulse generator, a pulsed current is sent to the medical catheter to effect pulse ablation. In practical use, the energy output device can simultaneously release ablation energy to at least one head electrode and at least one reference electrode to realize monopolar radiofrequency ablation or monopolar pulsed electric field ablation, wherein the reference electrode is also called a back electrode and is usually fixed on the back of a patient; alternatively, the energy output device may deliver ablation energy to the at least two tip electrodes simultaneously or to the at least one tip electrode and the at least one ring electrode simultaneously to form bipolar pulsed electric field ablation.

Further, the catheter tip may further include a ring electrode set including at least one ring electrode mounted at the distal end of the catheter body, and the head electrode set and the ring electrode set are insulated from each other by a second insulator. In this embodiment, the ring electrode assembly may be used for potential mapping, such as mapping a site of arrhythmia, and/or the ring electrode assembly may be used in conjunction with a head electrode assembly for discharging for ablation. The number of ring electrodes may be one, two, three or more. In actual use, the energy output device can deliver ablation energy to the at least one tip electrode and the at least one ring electrode simultaneously to form bipolar pulsed electric field ablation. Here, it should be understood that in bipolar ablation, it is sufficient to select a suitable electrode according to the ablation site, such as selecting a combination of a ring electrode and a head electrode, or selecting only a combination of head electrodes, so as to achieve adjustability of the electrodes and ensure that a plurality of electrodes are simultaneously attached to the target tissue.

Further, the medical catheter of the present invention further comprises a pulling device and a handle assembly. The traction device is arranged inside the pipe body. The handle assembly is connected with the proximal end of the tube body and is used for controlling the traction device to adjust the position and the direction of the electrode device. In more detail, the traction device comprises a bending control cable, the medical catheter is provided with a bendable section, the bending control cable is connected with the bendable section and is also connected with the handle assembly, the bending control cable controls the bendable section to bend under the control of the handle assembly to realize the adjustment of the position and the direction of the head electrode group, so that the head electrode group reaches various complicated and fine tissue structures, and then ablation energy is applied to target tissues through the head electrode group. Preferably, the electrode device is further used for extracting intracardiac electrocardiosignals, and in this case, the electrode device further comprises at least one microelectrode which is used for collecting intracardiac signals, and at least one microelectrode is insulated from all head electrodes. The number of microelectrodes is not limited in the present invention, and may be one, two, three or more. Preferably, the electrode device further has a temperature detection function for monitoring an actual temperature of the tissue during the ablation process to adjust an output of the ablation energy according to the fed back temperature, and at this time, the electrode device further includes at least one temperature sensor, which may be disposed on the head electrode, the micro-electrode or the insulator, and is insulated from all the head electrodes. More preferably, the temperature sensor is integrated with the micro-electrode. The term "integrated" means that the temperature sensor is disposed on the microelectrode, preferably inside the microelectrode, and the microelectrode itself has a temperature detection function.

The electrode device, the medical catheter and the ablation system according to the present invention will be further described with reference to the accompanying drawings and preferred embodiments. Although the following description uses a head electrode group including two or three head electrodes and an ablation catheter as an illustration, the illustration is not a limitation of the present invention, and the present invention is also applicable to a case of more head electrodes and a case of a mapping catheter or a medical catheter for other applications.

Reference is made to fig. 1, 2 a-2 b, and 3 a-3 b; the present embodiments provide a medical catheter that is compatible with both radiofrequency ablation and pulsed field ablation. The medical catheter includes a catheter body 8, the catheter body 8 including a catheter tip 100, the catheter tip 100 for application against a target tissue for ablation or electrical potential mapping. It should be understood that the portion encircled by the dashed line in fig. 1 is the catheter tip 100, and the catheter tip 100 in fig. 1 has been enlarged for easy understanding.

Wherein the catheter tip 100 is provided with an electrode arrangement comprising a set of head electrodes 1, the set of head electrodes 1 comprising at least two head electrodes, which are circumferentially distributed and are connected by a first insulator 3-1 to be insulated from each other, preferably, at least two head electrodes are evenly distributed along the circumference of the first insulator 3-1. And the electrode device is configured to have any cross section comprising at least two head electrodes, so that when the catheter head end 100 is attached to a target tissue in the whole ablation process, the head and some side surfaces of the electrode device can realize that the at least two head electrodes are attached to the target tissue at the same time, so that the pulsed electric field covers the target tissue rather than blood as much as possible, the ablation is more accurate and thorough, the ablation effect is improved, unnecessary injuries are reduced, and the ablation safety is improved. Therefore, the medical catheter provided by the embodiment can achieve more accurate and comprehensive ablation or more accurate potential mapping, greatly reduce the complexity of the operation, enhance the operability of the operation, shorten the operation time and reduce the risk in the operation process.

Optionally, the head electrode group 1 includes three head electrodes, which are a first head electrode 1-a, a second head electrode 1-B, and a third head electrode 1-C, respectively, and the three head electrodes are distributed along the circumferential direction of the first insulator 3-1, and preferably, the three head electrodes are uniformly distributed. In further embodiments, the head electrode group 1 includes two head electrodes or includes three or more head electrodes. More preferably, any longitudinal section of the electrode arrangement comprises a section of at least one head electrode. Taking three tip electrodes as an example, two or three of the three tip electrodes form a positive and negative electrode circuit during pulse ablation, and a pulsed electric field is generated to realize bipolar ablation, so that when the catheter tip 100 is attached to a target tissue, at least two tip electrodes can be attached to the target tissue at the same time to the maximum extent. In further embodiments, radiofrequency ablation may also be selected, in which case one, two or more head electrodes may be selected as energy input electrodes. Of course, in other embodiments, the polarity of the two head electrodes or the three head electrodes or more head electrodes during the pulse discharge may be the same, so as to realize the unipolar pulse discharge. Compared with unipolar pulse ablation, bipolar pulse ablation has less stimulation on muscles and better ablation effect.

The catheter tip 100 preferably further includes a loop electrode set 101 that can be used for potential mapping and/or for discharging in cooperation with the headset 1. The ring electrode set 101 includes one ring electrode or a plurality of ring electrodes, which are spaced apart along the axial direction of the catheter tip 100. In this embodiment, the ring electrode group 101 includes three ring electrodes, namely a first ring electrode 5, a second ring electrode 6 and a third ring electrode 7; the first ring electrode 5, the second ring electrode 6, and the third ring electrode 7 are arranged in this order from the distal end to the proximal end in the axial direction of the catheter tip 100, and these ring electrodes are insulated from each other. And the head electrode group 1 and the ring electrode group 101 are insulated from each other by a second insulator 3-2. In this embodiment, the head electrode group 1 may be isolated from the first ring electrode 5 by the second insulator 3-2. Further, the second insulator 3-2 is integrally formed with or separately connected to the first insulator 3-1, and further, the second insulator 3-2 is ring-shaped and is fitted over the first insulator 3-1 such that the second insulator 3-2 is located between the head electrode group 1 and the first ring electrode 5, and the second insulator 3-2 preferably closely contacts with the proximal end surface of the head electrode group 1 and the distal end surface of the first ring electrode 5.

Further, the electrode means is preferably a prism without corners, i.e. with a smooth outer surface, thereby preventing adverse tip discharge, avoiding arcing and affecting the ablation effect. Here, the head (i.e. the distal end) of the electrode device is smooth and has no sharp corners, for example, the head of the electrode device can be designed to be a smooth plane or a smooth curved surface (e.g. a spherical surface). Further, the electrode device is preferably a cylindrical structure, the distal end of the electrode device is smoothly transited to the outer peripheral surface, and more preferably, the distal end (i.e. the head) of the electrode device has a rounded corner (i.e. a rounded corner is formed between the distal end surface and the side surface), and the rounded corner is large enough to enable the electrode device to be attached to the target tissue to the maximum extent during the ablation process, so that the ablation effect is better. In addition, when the number of the head electrodes is two, the insulation distance between two head electrodes is preferably 0.15mm to 1.5mm, and similarly, when the number of the head electrodes is three or more, the insulation distance between any two adjacent head electrodes is also preferably 0.15mm to 1.5mm, and as for the joint of the first head electrode 1-a and the second head electrode 1-B, the joint of the second head electrode 1-B and the third head electrode 1-C, and the joint of the third head electrode 1-C and the first head electrode 1-a, the thickness of the insulation material at these joints is the insulation distance. Here, it is understood that the pulsed electric field is released as a positive and negative electrode signal between the two electrodes; if the distance between the head electrodes is too small, an electric spark phenomenon and a low-temperature plasma effect are easy to generate; if the distance between the head electrodes is too far, the electric field intensity is affected; in view of these problems, designing the insulation gap between the two head electrodes in the above range can secure the electric field energy intensity and does not generate ionization. Preferably, the head electrode group 1 and the first insulator 3-1 are integrally connected in a micro precise injection molding mode, so that the connection strength is high, the structural stability is strong, and the processing is convenient. In other embodiments, the head electrode assembly 1 and the first insulator 3-1 may be connected by machining, such as press-fit connection and/or snap-fit connection.

Further, the present embodiments also provide an ablation system comprising the medical catheter and an energy output device for selectively outputting ablation energy to the medical catheter, the ablation energy comprising pulsed ablation and/or radiofrequency ablation energy. In some embodiments, the energy output device is a radiofrequency meter for delivering a high frequency current to the medical catheter. In some embodiments, the energy output device is a pulse generator for delivering a pulsed current to the medical catheter, forming a unipolar or bipolar pulsed discharge. In other embodiments, the energy output device is a radio frequency pulse generator, which integrates radio frequency energy or pulse energy into one device, or a device which processes the radio frequency energy to generate a pulse signal, and then transmits the energy to the medical catheter to achieve ablation, which is not limited in this application.

In this embodiment, the ablation system preferably provides multiple discharge patterns to select the appropriate electrode for discharge based on the ablation site.

In some embodiments, the energy output device is configured for simultaneously releasing ablation energy to the at least one head electrode and the at least one ring electrode to form a bipolar discharge. In some embodiments, the energy output device is configured for releasing ablation energy to at least two tip electrodes simultaneously to form a bipolar discharge. In some embodiments, the energy output device is configured for simultaneously delivering ablation energy to the at least one head electrode and the at least one reference electrode to form monopolar radiofrequency ablation or monopolar pulsed electric field ablation, in which case the energy output device is further connected to the at least one reference electrode, the reference electrode being placed on the back of the patient.

Further preferably, the electrode arrangement further comprises at least one microelectrode 2 for acquiring intracardiac signals and/or for detecting the temperature of the target tissue or the electrode. At least one micro-electrode 2 may be mounted on the head electrode, and may also be mounted on the first insulator 3-1, with the micro-electrode 2 and the head electrode insulated from each other. In this embodiment, the microelectrodes 2 are mounted on the head electrodes, and preferably at least one microelectrode 2 is provided on each head electrode. Specifically, the side surface of the head electrode is provided with a through mounting hole (see fig. 5b, not labeled), and the microelectrode 2 is placed in the mounting hole of the head electrode and is insulated from the head electrode. For example: the microelectrode 2 is adhered with the head electrode by glue, so that the microelectrode and the head electrode are electrically isolated from each other by glue, for example, the microelectrode 2 is fixed on the head electrode by medical insulating glue; or a non-metallic insulator is added between the microelectrode 2 and the head electrode to realize the isolation. Preferably, the number of the micro-electrodes 2 is 2 to 8, and these micro-electrodes may be arranged on the same head electrode or on different head electrodes, and preferably, the micro-electrodes 2 are arranged on the side (i.e., outer circumferential surface) of the head electrode group 1. The microelectrode 2 is made of metal and is mainly used for detecting electrocardiosignals, preferably, a temperature sensor is arranged in the microelectrode 2 and is used for monitoring the actual temperature of tissues or electrodes in the ablation process. In other embodiments, the temperature sensors may also be disposed within the head electrode and insulated from each other. Further, the inner side of the microelectrode 2 is connected with a lead wire, including a microelectrode lead wire and/or a TC wire (the TC wire is a temperature sensor lead wire), and similarly, the inner side of the head electrode is also connected with a lead wire, the lead wires are all arranged and extended in a lead wire passage, and the lead wire of the head electrode and the lead wire of the microelectrode can share the same lead wire passage, and can also be arranged in different lead wire passages.

Referring to fig. 2b, fig. 5b, and fig. 4a to fig. 4b, in the present embodiment, a lead path 1-F is disposed on an inner side surface of each of the head electrodes, a lead 15 is disposed in the lead path 1-F, and the lead 15 can be fixedly connected to the inner side surface of the head electrode by welding. Further, a mounting hole for mounting the micro-electrode 2 is penetrated through the lead line via 1-F, and the micro-electrode lead line and/or TC line may be disposed in the lead line via 1-F penetrated through the mounting hole.

Preferably, the electrode device further comprises a plurality of perfusion holes 4 for releasing the cooling medium. Meanwhile, the interior of the catheter tip 100 is provided with a perfusion channel 41 (see fig. 2b), and the perfusion channel 41 is communicated with the perfusion hole 4. In this embodiment, the perfusion channel 41 comprises a portion located inside the electrode device and a portion located inside the tube 8. Further, the filling hole 4 includes a portion opened on the side of the head electrode and a portion opened on the first insulator 3-1. Preferably, each head electrode is provided with a perfusion hole 4, and the specific number and arrangement mode of the perfusion holes 4 are not limited. And the irrigation channel 41 in the electrode assembly is separated from any of the lead paths 1-F by the first insulator 3-1 to avoid interference. In addition, a cooling medium, such as saline or other substances, may optionally be used to cool the target tissue or the electrode at the tip of the catheter during the ablation procedure to more precisely control the temperature of the target tissue or the electrode at the tip of the catheter. The present invention does not particularly limit the relative positions of the perfusion wells 4 and the microelectrodes 2, as long as they do not interfere with each other. In this embodiment, the mounting hole is axially closer to the proximal end of the electrode arrangement than the irrigation hole 4.

Referring back to fig. 1, the medical catheter further includes a handle assembly 102 and a pulling device (not shown), the handle assembly 102 being connected to the proximal end of the tube 8, the pulling device being disposed inside the tube 8. The handle assembly 102 is used for controlling the traction device to adjust the position and the direction of the head electrode group 1. Further, the handle assembly 101 comprises a bending control pushing piece 10 and a handle 11; the bending control pushing piece 10 is arranged at the near end of the tube body 8 and is positioned between the tube body 8 and the handle 11; the traction device is controlled by the bending control pushing piece 10 to pull, so that the bendable section of the tube body 8 is bent, and the head electrode group 1 is guided to be close to the target tissue. In addition, the handle assembly 102 includes a signal port 12, an energy source port 13, and a cooling medium infusion port 14. The lead of the microelectrode 2, even the lead of a ring electrode for mapping, the lead of a temperature sensor and the lead of a strain gauge, which are described below, are connected with a signal port 12 at the near end of the handle 11, and the signal port 12 can instantly reflect the performance of the catheter (including information such as temperature, pressure, electrocardio signals and the like) through a signal display instrument. The energy output device is connected to the energy port 13 and delivers ablative energy through the energy port 13 to the tip electrode, or even the ring electrode. The cooling medium perfusion port 14 is communicated with the perfusion channel 41, so that an external cooling medium supply device can input the cooling medium into the medical catheter through the cooling medium perfusion port 14. The method specifically comprises the following steps: the cooling medium is filled through the cooling medium filling port 14, so that the cooling medium flows to the filling channel 41 in the electrode device along the filling channel 41 in the pipe body 8 and further flows into the filling hole 4 on the electrode device, and the cooling medium is released from the filling hole 4 to be cooled.

Further preferably, the catheter tip 100 is further provided with a pressure sensor, and the pressure sensor of the catheter tip 100 senses the pressure of the catheter tip 100 against the target tissue to evaluate the contact strength or whether the catheter tip is contacted with the target tissue.

Referring to fig. 2b, the pressure sensor includes an elastic tube 16 and at least one strain gauge (not shown) disposed on the elastic tube 16. The at least one strain gauge is used for sensing the deformation of the elastic tube 16 to output a varying electrical signal according to the deformation of the elastic tube 16, so as to obtain the pressure of the catheter tip 100 against the target tissue according to the varying electrical signal. Preferably, the number of the strain gauges is three, and the three strain gauges are uniformly arranged along the circumferential direction of the elastic tube body 16, and may be arranged on the same circumference or different circumferences. Further, the electrode device is connected to and coaxially arranged with the elastic tube body 16 through the first insulator 3-1.

Further, the medical catheter further comprises an inner tube 17, the elastic tube 16 wraps the inner tube 17, the distal end of the inner tube 17 is fixedly connected with the first insulator 3-1 (such as threaded connection, welding or glue bonding), the tube 8 wraps the elastic tube 16, and the ring electrode assembly 102 is mounted on the tube 8. Preferably, the tube 8 and the elastic tube 16 form a wire passage 1-F therebetween. Alternatively, the first insulator 3-1 has an internal thread and the inner tube 17 has an external thread. Preferably, the distal end of the inner tube 17 is formed with a step, so that the proximal end face of the first insulator 3-1 is closely attached to the step face of the inner tube 17.

Further, the head electrode group 1 is preferably connected to the first insulator 3-1 in a press-fit manner, that is, the head electrode is assembled by using the elasticity of the first insulator 3-1, and more preferably, the head electrode is also snap-fitted to the first insulator 3-1, thereby forming a more secure fit.

Referring to fig. 2b to 2c, 3a to 3b, and 5a to 5d, the first insulator 3-1 has at least two fitting grooves 3-3 circumferentially distributed, and one head electrode is mounted in each fitting groove 3-3. Taking three head electrodes as an example, the fitting grooves 3-3 are also three. One of the first insulator 3-1 and the head electrode is provided with a buckle 3-4, the other is provided with a clamping groove 1-D, and the buckle 3-4 is connected with the clamping groove 1-D in a matching mode. Optionally, each assembling groove 3-3 of the first insulator 3-1 is provided with a buckle 3-4, and the inner side surface of each head electrode is provided with a clamping groove 1-D. The invention has no requirements on the shapes of the buckles and the clamping grooves, and the quantity and the positions of the buckles and the clamping grooves. Optionally, as shown in fig. 5D, each of the assembly grooves 3-3 is provided with a snap 3-4, the number of the snap 3-4 is one and is preferably arc-shaped, correspondingly, the inner side surface of each of the head electrodes is provided with a snap groove 1-D, and the number of the snap grooves 1-D is also one and is preferably arc-shaped. The arc-shaped buckles 3-4 extend along the circumferential direction of the first insulator 3-1, and the arc-shaped clamping grooves 1-D extend along the circumferential direction of the head electrode.

Furthermore, at least part of the inner edge of any one of the head electrodes is in concave-convex fit connection with the corresponding side wall of the assembly groove 3-3, so that the connection strength between the head electrode and the first insulator 3-1 is further enhanced, the structure of the head electrode device is more stable, and the electrode is prevented from falling off. Preferably, for example, as shown in fig. 5a and 3b, a groove 1-E is formed on an inner side edge of each head electrode, correspondingly, as shown in fig. 2d, a protrusion (a portion circled by a dotted line in fig. 2 d) is provided on a side wall of the fitting groove 3-3 that mates with the head electrode, and the head electrode and the first insulator 3-1 are integrally formed by injection molding, so that the first insulator 3-1 is formed in the head electrode, and the protrusion on the side wall can effectively prevent the head electrode from being separated from the first insulator 3-1 during use, and has extremely high connection reliability.

Of course, in other embodiments, it is also possible to form a protrusion on the inner side edge of each head electrode, or a groove matching with the protrusion on the head electrode, or the inner side edge of the head electrode has both a groove and a protrusion, and the inner side edge of the first insulator 3-1 also has a groove and a protrusion matching therewith (as circled by the dotted line in fig. 2 d). Preferably, the tip electrode is ground to have a rounded structure at the location where the tip electrode has sharp corners, thereby preventing the problem of the tip discharge.

Further, the first insulator 3-1 may be connected to the distal end of the tube 8 by means of threads, heat welding or glue, and more preferably, is connected by threads, and has high connection strength.

Referring to fig. 2b in conjunction with fig. 5c and 5d, the first insulator 3-1 includes a rod-shaped body 31 and a latch 32, wherein the latch 32 has at least two latch arms 33; the jaws 32 are arranged on the rod-shaped body 31 and coaxially arranged, and the two can be integrally formed or connected in a split way; each clamping arm 33 is fixedly connected with the rod-shaped body 31, and a mounting groove 3-3 is formed between the two clamping arms 33 and used for mounting the head electrode; and the inside of the rod-shaped body 31 forms a pouring channel 41, and an internal thread is provided at the proximal end of the rod-shaped body 41 so as to be screwed with the inner tube 17. In other embodiments, the proximal end of the rod-shaped body 41 may also be externally threaded. Preferably, the side surface of the chucking arm 33 is connected to the head electrode in a concavo-convex fit.

Further, the tubular body 8 is preferably a multi-lumen tube so as to form various passages such as a wire passage, a bend-controlling cable passage, a perfusion passage, etc. inside the tubular body 8.

Referring next to fig. 6a to 6c, during the pulse ablation, the adjacent head electrodes form a pulse electric field to act on the target tissue, and the adjacent head electrodes in the head electrode group are isolated by using an insulating material to achieve the electric field distribution shown in the figure; wherein "+" denotes a positive electrode; "-" denotes a negative electrode; "+/-" indicates that either the negative or positive electrode is possible. When the number of the head electrodes is more than 3, the electrode density of the electrode device is larger, for example, 3 electrodes in fig. 6b and 4 electrodes in fig. 6c, compared with 2 electrodes in fig. 6a, the electric fields generated by two electrodes are more compact, and a more comprehensive electric field coverage range can be realized by mutual overlapping, and an operator can selectively generate the electric field in the whole circumferential range of the electrode device by selecting two electrodes, so that the electrode device has a higher possibility that at least two head electrodes are attached to target tissues at any time and any position, the electric field coverage range is larger, and the ablation effect is better.

It should be understood that when the head electrode group includes 3 head electrodes, the positive and negative electrodes of the electrodes may be selectively set according to the position where the head electrode contacts the target tissue, such as selecting 2 head electrodes as the positive electrode and 1 head electrode as the negative electrode, or 2 head electrodes as the negative electrode and 1 head electrode as the positive electrode. As described above, when the number of the head electrodes is 3 or 4, the pulse electric field formed by the head electrodes is distributed more uniformly, and hardly covers a weak point, which is advantageous for more precise and complete ablation. Therefore, under the same electric field parameters, compared with 2 head electrodes, the current density of 3 head electrodes or 4 head electrodes is larger, the electric field distribution is more uniform, the coverage area of the electric field is wider, the ablation effect is better, and under the condition of 2 head electrodes, the coverage area of the electric field is small, and the ablation effect is relatively poor. Therefore, the electrode device preferably includes 3 to 4 head electrodes. Wherein, more preferably, the number of the head electrodes is 3, and at this time, any longitudinal section of the electrode device comprises at least one section of the head electrode, so that not only can the technical effect of the above-mentioned electric field overall coverage be realized, but also the electric arc harmful to human body caused by too small electrode volume and too close distance between the electrodes can be effectively avoided.

In summary, according to the technical solutions provided by the embodiments of the present invention, after the medical catheter of the present invention is used, in the whole ablation process, a suitable electrode can be selected to form a pulsed electric field according to the ablation site, and it can be ensured that a plurality of electrodes simultaneously contact the target tissue, so that the energy covers the target tissue rather than blood as much as possible, more accurate and comprehensive ablation is achieved, unnecessary injuries are reduced, and the ablation safety is improved. In addition, the invention can select ablation energy, such as radio frequency ablation or pulsed electric field ablation, so that 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 experience of a doctor, thereby achieving more accurate and comprehensive ablation, greatly reducing the complexity of the operation, enhancing the operability of the operation, shortening the operation time and reducing the risk in the operation process.

It should be understood that the above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any way and substantially, for example, the present invention is not limited to the sector-shaped head electrodes, in any way, as long as it is ensured that the head electrode group includes at least two head electrodes in any one cross-section throughout the ablation process, and the head electrode groups can be insulated from each other by the first insulator. Moreover, while the innovation of the present invention originates from the field of ablation catheters and their ablation techniques, those skilled in the art will appreciate that the invention is also applicable to mapping catheter techniques.

It should also be understood that the above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention in any way and in any way, and that the inventive subject matter, although derived from cardiac ablation, will be understood by those skilled in the art to apply the present invention to ablation of different sites, such as renal artery ablation, bronchial ablation, etc., and not to limit the present invention in this regard.

It should be noted that, for a person skilled in the art, several modifications and additions can be made without departing from the method of the invention, which should also be considered as a protection scope of the invention. Those skilled in the art can make various changes, modifications and equivalent arrangements, which are equivalent to the embodiments of the present invention, without departing from the spirit and scope of the present invention, and which may be made by utilizing the techniques disclosed above; meanwhile, any changes, modifications and variations of the above-described embodiments, which are equivalent to those of the technical spirit of the present invention, are within the scope of the technical solution of the present invention.

Claims

1. An electrode device, comprising a head electrode group, wherein the head electrode group comprises at least two head electrodes distributed circumferentially, at least two head electrodes are connected through a first insulator, and the electrode device is configured such that any one cross section contains a cross section of at least two head electrodes.

2. The electrode device according to claim 1, wherein at least two of the head electrodes are uniformly arranged in a circumferential direction of the first insulator.

3. The electrode assembly of claim 1 or 2, wherein at least two of the head electrodes are injection molded with the first insulator, or wherein at least two of the head electrodes are snap fit and/or press fit with the first insulator.

4. The electrode assembly of claim 1 or 2, wherein said first insulator has at least two circumferentially distributed mounting slots, one said head electrode being mounted in each said mounting slot;

one of the first insulator and the head electrode is provided with a buckle, and the other is provided with a clamping groove, and the buckle is connected with the clamping groove in a matched manner; and/or the presence of a gas in the gas,

at least part of the inner edge of any one of the head electrodes is in concave-convex fit connection with the side wall of the assembly groove.

5. The electrode assembly of claim 4 wherein said mounting slot of said first insulator has a snap disposed thereon, said inner side of said tip electrode has a snap slot, and said snap slot are both arcuate.

6. The electrode device according to claim 1 or 2, characterized in that the electrode device further comprises a perfusion channel and a perfusion hole, wherein the perfusion hole is formed in the side surface of the electrode device and is communicated with the perfusion channel; and a lead passage is arranged on the inner side surface of each head electrode, and the perfusion channel is separated from the lead passage through the first insulator.

7. The electrode device according to claim 1 or 2, further comprising at least one microelectrode for detecting electrocardiosignals, said microelectrode being insulated from said group of head electrodes;

8. The electrode device according to claim 1 or 2, wherein the first insulator comprises a rod-shaped body and a jaw having at least two catching arms; the clamping jaws are arranged on the rod-shaped body and are coaxially arranged, each clamping arm is fixedly connected with the rod-shaped body, and one head electrode is arranged between the two clamping arms; the proximal end of the rod-shaped body is provided with threads.

9. The electrode device according to claim 1 or 2, wherein the number of the head electrodes is two, and the insulation interval between two of the head electrodes is 0.15mm to 1.5mm, or the number of the head electrodes is at least three, and the insulation interval between any adjacent two of at least three of the head electrodes is 0.15mm to 1.5 mm.

10. The electrode device according to claim 1 or 2, wherein the electrode device has a smooth outer surface and/or wherein rounded corners are formed between the distal and lateral surfaces of the electrode device.

11. The electrode device according to claim 1 or 2, wherein the number of the head electrodes is 3, and any longitudinal section of the electrode device includes a section of at least one of the head electrodes.

12. A medical catheter comprising a tubular body including a catheter tip, the catheter tip being provided with an electrode arrangement according to any one of claims 1 to 11.

13. The medical catheter of claim 12, wherein the catheter tip further comprises an elastic tube body and at least one strain gauge disposed on the elastic tube body; the electrode device is connected with the elastic tube body and is coaxially arranged; and/or the presence of a gas in the gas,

the catheter tip further comprises a ring electrode set comprising at least one ring electrode mounted on the catheter body, and the tip electrode and the ring electrode are insulated from each other by a second insulator; the ring electrode is used for potential mapping or is used for being matched with the head electrode to release ablation energy.

14. An ablation system comprising a medical catheter as in any of claims 12-13, and further comprising an energy output device for selectively outputting ablation energy to the medical catheter, the ablation energy comprising pulsed ablation and/or radiofrequency ablation energy.

15. The ablation system of claim 14, wherein the medical catheter further comprises a ring electrode set including at least one ring electrode mounted on the catheter body, the head electrode and the ring electrode being insulated from each other by a second insulator, and the ablation system has the following ablation modes: