CN215651496U - Electrode device, medical catheter and ablation system - Google Patents

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 electrode device; the medical catheter comprises a catheter body, the catheter body comprises a catheter head end, and an electrode device is arranged at the catheter head end; the electrode device comprises a head electrode group, wherein the head electrode group comprises at least two head electrodes which are connected through a first insulator; the electrode device is provided with a specific area, and any cross section and any longitudinal section of the specific area both comprise the sections of at least two head electrodes; thereby realizing more accurate and comprehensive ablation and improving the ablation effect.

Description

Electrode device, medical catheter and ablation system

Technical Field

The utility model 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. For example, radiofrequency ablation has been precipitated for many years, and on one hand, ablation techniques are mature, and on the other hand, the radiofrequency ablation experience of doctors is rich. 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, the attachment of electrodes and the tissues can not be realized at any position 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.

SUMMERY OF THE UTILITY MODEL

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 problem that the ablation energy field, especially the pulsed electric field, cannot be concentrated to cover the target tissue, so that the target tissue is not completely ablated.

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 connected through a first insulator; and the electrode device is provided with a specific area, and any cross section and any longitudinal section of the specific area comprise at least two sections of the head electrode.

Optionally, the specific region is defined by a distal end face of the electrode device and at least part of an outer circumferential surface of the electrode device.

Optionally, each of the head electrodes is configured as a spirally extending curved structure, at least two of the head electrodes are coaxial and spaced apart from each other, and at least two of the head electrodes each spirally extend along the axis of the first insulator;

the first insulator is provided with a concave structure, the concave structure is in a curved surface shape, and at least two head electrodes are arranged at the concave structure.

Optionally, the first insulator comprises a rod-shaped body and a curved structure wound on the rod-shaped body, and the curved structure and the rod-shaped body form the recessed structure therebetween; each head electrode is matched and fixed with the concave structure.

Optionally, the number of the head electrodes is two, and the two head electrodes are nested; one of the head electrodes comprises a top cover and at least two first branches connected with the top cover, the at least two first branches are distributed along the circumferential direction of the top cover, the other head electrode comprises a bottom and at least two second branches connected with the bottom, and the at least two second branches are distributed along the circumferential direction of the bottom;

the number of the first branches is the same as that of the second branches, one first branch is arranged between every two adjacent second branches, and one second branch is arranged between every two adjacent first branches; and/or the first branch and the second branch are arranged in parallel with each other.

Optionally, the electrode device further comprises at least one microelectrode for acquiring intracardiac signals, the microelectrode and the head electrode being insulated from each other, and/or the electrode device further comprises at least one temperature sensor for acquiring a temperature of the target tissue, the temperature sensor and the head electrode being insulated from each other.

Optionally, when the electrode device comprises a plurality of said microelectrodes, the plurality of said microelectrodes are arranged on the distal end face of the electrode device and/or on the outer peripheral surface of the electrode device.

Optionally, the number of the head electrodes is two, and two microelectrodes are arranged on the distal end surface of the electrode device;

at least part of two of the head electrodes, at least part of one of the first insulators, and two of the microelectrodes are arranged in a tai chi pattern on a distal end face of the electrode device, the first insulator being disposed between the two head electrodes.

Optionally, the number of the head electrodes is three, three the head electrodes are arranged along the circumference of the first insulator and arranged on the distal end surface of the electrode device to form a three-petal structure, the first insulator is arranged between every two adjacent head electrodes, and a microelectrode is arranged on each petal of the distal end surface of the electrode device.

Optionally, the electrode device further comprises a plurality of perfusion holes for releasing a cooling medium; the filling hole is provided on the first insulator or the head electrode.

Optionally, the insulation distance between at least two of the head electrodes is 0.15mm to 1.5 mm.

Optionally, the electrode device has a smooth outer surface, and/or the electrode device is of a cylindrical structure.

Optionally, at least two of the head electrodes are connected to the first insulator by injection molding.

Optionally, a conductor is disposed inside each of the head electrodes, and penetrates the first insulator and extends in an axial direction of the first insulator.

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.

Optionally, the catheter tip further comprises a ring electrode set including at least one ring electrode, at least one ring electrode is mounted on the catheter body, and the head electrode set and the ring electrode set are insulated from each other by a second insulator.

In order to achieve the above object, according to a third aspect of the present invention, there is provided an ablation system comprising any of the medical catheters, 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.

Optionally, the energy output device is a radiofrequency meter and/or a pulse generator;

when the energy output device is a radiofrequency instrument, the energy output device is used for outputting radiofrequency current to at least one head electrode in the medical catheter;

when the energy output device is a pulse generator, the energy output device is used for outputting pulse current to at least two head electrodes in the medical catheter.

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

first, the electrode device has a specific area, and any cross section and any longitudinal section of the specific area both comprise the sections of at least two head electrodes, so that when the electrode device is attached to a target tissue, the electrode device and the target tissue can simultaneously attach at least two head electrodes to the target tissue under any condition, and the target tissue is ablated more thoroughly or the 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, the medical catheter can realize pulse discharge of the head electrode group, effectively reduce muscle stimulation to a patient and improve the ablation safety.

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 utility model;

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

FIG. 2b is a left side view of the catheter tip shown in FIG. 2a taken along direction A-A;

FIG. 2c is a transverse cross-sectional view of the catheter tip shown in FIG. 2a taken along the direction B-B, wherein the section lines are not shown;

FIG. 3 is a schematic diagram of the construction of a pressure sensor in a preferred embodiment of the utility model;

FIG. 4a is an exploded view of two of the head electrodes in the head electrode assembly in a preferred embodiment of the present invention;

FIG. 4b is a schematic view of the assembly of two head electrodes in the head electrode group according to the preferred embodiment of the present invention;

FIG. 4c is a schematic diagram of the first insulator in the head electrode set according to the preferred embodiment of the present invention;

FIG. 5a is a schematic view of the catheter tip in apposition to tissue in a preferred embodiment of the present invention;

FIG. 5b is a schematic view of the catheter tip in a preferred embodiment of the present invention after adjustment of the position against tissue;

FIG. 6a is a schematic diagram of the relative positions of two head electrodes in a front view in accordance with a preferred embodiment of the present invention;

FIG. 6b is a schematic diagram of the relative positions of the two head electrodes in a left side view in accordance with the preferred embodiment of the present invention;

FIG. 6c is a schematic diagram showing the relative positions of two head electrodes in a top view in accordance with a preferred embodiment of the present invention;

FIG. 6d is a schematic view taken along line C-C of FIG. 6C;

FIG. 7a is a front view of a head electrode assembly in a preferred embodiment of the present invention;

FIG. 7b is a perspective view of a head electrode assembly in a preferred embodiment of the present invention;

FIG. 7c is a top view of the head electrode assembly in a preferred embodiment of the present invention;

FIG. 8 is an exploded view of two head electrodes of a head electrode group according to another preferred embodiment of the present invention;

FIG. 9a is a schematic diagram of the relative positions of two head electrodes in a front view in accordance with another preferred embodiment of the present invention;

FIG. 9b is a schematic diagram showing the relative positions of two head electrodes in a left side view in accordance with another preferred embodiment of the present invention;

FIG. 9c is a schematic diagram showing the relative positions of two head electrodes in a top view in accordance with another preferred embodiment of the present invention;

fig. 9d is a schematic perspective view of the relative positions of two head electrodes in another preferred embodiment of the present invention.

The reference numerals are explained below:

100-a catheter tip; 101-head electrode group; 101 a-a helical segment; 101 b-straight line segment; 1-a first head electrode; 111-a top cover; 112-first branch; 2-a second head electrode; 211-bottom; 212-second branch; 18-a third head electrode; 3-microelectrodes; 3-1 a first microelectrode; 3-2-a second microelectrode; 102-ring electrode set; 5-a first ring electrode; 6-a second ring electrode; 7-a third ring electrode; 4-1-a first insulator; 411-a rod-shaped body; 412-curved configuration; 413-a recessed structure; 4-2-a second insulator; 8-a pipe body; 103-a handle assembly; 9-controlling the bending pushing piece; 10-a handle; 11-a signal port; 12-an energy port; 13-cooling medium pouring opening; 14-a perfusion channel; 15-controlling the bending channel; 16-a wire channel; 17-target tissue; 104-an elastic tube body; 105-strain gauge.

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 utility model 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 utility model. 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, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are 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 utility model.

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, and "distal" 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 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 connected to be insulated from each other by a first insulator; and the electrode device is provided with a specific area, and any cross section and any longitudinal section of the specific area comprise at least two sections of the head electrode. The specific region of the electrode device may be provided in some or all of the entire electrode device, and preferably, the specific region is defined by the distal end surface of the electrode device and at least a part of the outer peripheral surface of the electrode device. "distal face" refers to the end face of the distal end of the electrode device. So constructed, when the medical catheter using the electrode device, such as an ablation catheter, is attached to the target tissue, the electrode device and the target tissue can realize that at least two head electrodes are attached to the target tissue at the same time under any condition, so that the target tissue is ablated more thoroughly or the electric potential mapping is more accurate. It should be understood that the tip electrode is not limited to an ablation electrode, but may be a mapping electrode.

It is a further object of the present invention to provide a medical catheter, which may be an ablation catheter or a mapping catheter. The medical catheter comprises a catheter body, wherein the catheter body comprises a catheter head end, and the electrode device is arranged at the catheter head end. When the head electrode in the electrode device is used for ablation, the radiofrequency energy ablation and the pulsed electric field ablation can be used, namely, the head electrode can receive the pulsed current to achieve the purpose of pulse ablation and can also receive the high-frequency current to achieve the purpose of radiofrequency 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 radio frequency ablation, one head electrode can be selected to be electrically conducted to receive high-frequency current, or more head electrodes can be selected to be electrically conducted to receive high-frequency current; when the pulse ablation is carried out, at least one pair of head electrodes can be selected to be conducted, and more head electrodes can also be selected to be conducted; the pulse ablation is preferably a bipolar ablation, i.e. the two head electrodes of a pair of head electrodes are of opposite polarity. 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 other sites (e.g., kidneys) or diseases. Therefore, in the whole ablation process, at any time and at any position, when the medical catheter is in contact with the tissue, the at least two head electrodes can be attached to the target tissue at the same time, so that the ablation energy field, particularly the pulse electric field, covers the target tissue rather than blood as much as possible, and a better ablation effect or a better potential mapping effect is achieved.

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 far end of the catheter can carry out tissue ablation or potential mapping through the head electrode, the magnitude and the direction of the contact force when the far end of the catheter is contacted with the tissue can be obtained, 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 device and/or a pulse generator, 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 an electrode device in the medical catheter to realize radiofrequency ablation; when the energy output device is a pulse generator, a pulsed current is sent to an electrode device in a medical catheter to effect pulse ablation.

Further, the catheter tip further comprises a ring electrode set including at least one ring electrode mounted on the tube or the elastic tube, and the head electrode set and the ring electrode set are insulated from each other by a second insulator. Here, the ring electrode set is used for potential mapping, such as mapping a site of arrhythmia. The number of the ring electrodes is not limited in the utility model, and may be one, two, three or more.

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 near end of the tube body and is used for controlling the traction device to adjust the position and the direction of the head electrode group. 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 the handle assembly, the bending control cable controls the bending of the bendable section 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 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 the actual temperature of the tissue during the ablation process to adjust the output of the ablation energy according to the fed back temperature, and in this case, the electrode device further includes at least one temperature sensor, which may be disposed on the head electrode or the micro-electrode and insulated from these 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, and preferably, the temperature sensor is disposed inside the microelectrode, so that the microelectrode 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 purposes.

Fig. 1 is a schematic structural view of a medical catheter in accordance with a preferred embodiment of the utility model, fig. 2a is an enlarged view of the catheter tip shown in fig. 1, fig. 2B is a view of the catheter tip shown in fig. 2a taken along the direction a-a, and fig. 2c is a transverse cross-sectional view of the catheter tip shown in fig. 2a taken along the direction B-B.

Referring to fig. 1, 2a to 2c, the present embodiment provides a medical catheter compatible with radio frequency and pulsed field ablation. The medical catheter comprises a catheter body 8, wherein the catheter body 8 comprises a catheter tip 100, and the catheter tip 100 is used for applying ablation or potential mapping to the target tissue. 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 device, the electrode device comprises a head electrode group 101, the head electrode group 101 comprises at least two head electrodes, and a first insulator is arranged at the joint of the at least two head electrodes and is used for insulating the head electrodes from each other. In particular, the group of head electrodes 101 has a specific area for contact with the target tissue, and any cross section and any longitudinal section of the specific area include at least two sections of head electrodes. It is to be understood that any one cross section of the specific region includes a cross section of at least two head electrodes, and any one longitudinal section of the specific region includes a longitudinal section of at least two head electrodes. Preferably, the external surface (mainly the distal end surface) of the electrode head group 101 in the transverse direction includes at least two electrode heads, and at least a part of the external surface (i.e. the external circumferential surface) in the circumferential direction includes at least two electrode heads. By doing so, when the catheter head end 100 is attached to the target tissue in the whole ablation process, at least two head electrodes can be attached to the target tissue at the same time, the ablation energy field (preferably, the pulse electric field) covers the target tissue but not blood as much as possible, a better ablation effect is achieved, the ablation is more thorough, and the ablation effect is improved. That is to say, the medical catheter of the embodiment can achieve more accurate and comprehensive ablation, 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 101 includes two head electrodes, namely a first head electrode 1 and a second head electrode 2. The two head electrodes can form a positive and negative electrode loop during pulse discharge, realize bipolar pulse discharge, so as to be contacted with target tissues for ablation or mapping, and are attached to the tissues at any position of the circumference of the catheter head end 100, the first head electrode 1 and the second head electrode 2 can be attached to the target tissues to the maximum extent at the same time, and simultaneously, the attachment of the two head electrodes to the target tissues can be realized at the position of the far end surface of the catheter head end 100. In other embodiments, the two head electrodes may serve as energy input electrodes simultaneously or alternatively during radiofrequency ablation. Of course, in other embodiments, the polarity of the two head electrodes during pulse discharge may be the same, so as to realize unipolar pulse discharge.

Further, the catheter tip 100 further includes a ring electrode set 102 for performing potential mapping of the target tissue, where the ring electrode set 102 is mainly used for potential mapping and the head electrode set 101 is used for tissue ablation. Of course, in other embodiments, the ring electrode set 102 may also be used for tissue ablation, the headset 101 may be used for electrical potential mapping, or the ring electrode set 102 may be used in conjunction with the headset 101 for ablation or electrical potential mapping. The ring electrode set 102 includes one ring electrode or a plurality of ring electrodes (a plurality means at least two). Optionally, the set of ring electrodes 102 includes three ring electrodes, namely a first ring electrode 5, a second ring electrode 6, and a third ring electrode 7, which are axially spaced apart and insulated from each other on the body of the catheter tip 100. Further, the head electrode group 101 and the ring electrode group 102 are insulated from each other by a second insulator 4-2. In this embodiment, the joints of the respective head electrodes in the head electrode group 101 are insulated from each other by the first insulator 4-1, and the head electrode group 101 and the ring electrode group 102 are insulated from each other by the second insulator 4-2. Further, the second insulator 4-2 is integrally formed with or separately connected to the first insulator 4-1, and further, the second insulator 4-2 is ring-shaped and is fitted over the first insulator 4-1 such that the second insulator 4-2 is located between the head electrode group 101 and the first ring electrode 5, and the second insulator 4-2 preferably closely contacts the proximal end surface of the head electrode group 101 and the distal end surface of the first ring electrode 5.

Preferably, the electrode device is a cylinder without edges and corners, i.e. has a smooth outer surface, so as to prevent adverse point discharge and avoid electric arc generation and influence on the ablation effect. Here, the head (i.e. the distal end) of the electrode device is also smooth and has no sharp corners, for example, the head is a smooth plane or a smooth curved surface (such as a spherical surface), and further, the electrode device is a cylindrical structure, and the distal end portion of the electrode device is smoothly transited to the outer peripheral surface. Further, when the head electrodes are two, the insulation interval between the two head electrodes is preferably 0.15mm to 1.5mm, for example, the insulation interval at the joint of the first head electrode 1 and the second head electrode 2 is 0.15mm to 1.5 mm. Similarly, when the number of the head electrodes is three or more, the insulation distance between any two adjacent head electrodes is 0.15mm to 1.5 mm. Here, it should be understood that, since the pulse electric field is released as positive and negative electrode signals between the two electrodes, if the distance between the two electrodes is too small, the spark phenomenon and the low temperature plasma effect are easily generated; if the distance between the head electrodes is too far, the electric field intensity is affected; in view of these problems, the distance between the two head electrodes is designed to be in the above range in which the electric field energy intensity can be secured and ionization is not generated. Preferably, the head electrode group 101 and the first insulator 4-1 are integrally injection-molded in a micro precision injection molding manner, so that the connection strength and the stability are high. In another embodiment, the head electrode group 101 and the first insulator 4-1 may be connected by machining, which is not limited herein.

Further preferably, the headset 101 further comprises at least one microelectrode 3 for acquiring intracardiac signals and/or target tissue temperature. At least one of the micro-electrodes 3 may be mounted on the head electrode, and may also be mounted on the first insulator 4-1, with the micro-electrode 3 and the head electrode insulated from each other. In this embodiment, the micro-electrode 3 is mounted on a head electrode, for example, a micro-electrode mounting hole is provided on the head electrode, and the micro-electrode 3 is placed in the micro-electrode mounting hole and is insulated from the head electrode. For example: the micro-electrode 3 is adhered to the head electrode by glue so as to be electrically isolated from each other by a gel, for example, the micro-electrode 3 is fixed to the first head electrode 1 or the second head electrode 2 by using medical insulating gel. Or a non-metallic insulator is added between the microelectrode 3 and the head electrode to realize the isolation. Preferably, the number of the micro-electrodes 3 is 2 to 8, in this embodiment, the number of the micro-electrodes 3 is 4, and the number is two first micro-electrodes 3-1 and two second micro-electrodes 3-2, optionally, the two first micro-electrodes 3-1 are located on the distal end surface of the head electrode group 101, and the two second micro-electrodes 3-2 are located on the outer peripheral surface (side surface) of the head electrode group 101, but the number and arrangement of the micro-electrodes 3 are not limited to this example, and in other embodiments, a plurality of micro-electrodes 3 are arranged on the distal end surface and/or the outer peripheral surface of the electrode device. The microelectrode 3 is made of metal and used for detecting electrocardiosignals, and preferably, a temperature sensor is arranged in the microelectrode 3 and used for monitoring the actual temperature of tissues in the ablation process. In other embodiments, the temperature sensors may also be disposed within the head electrode and insulated from each other. The present invention does not particularly require the position of the micro-electrode 3, and it is preferable that the micro-electrode 3 is provided on the side (outer circumferential surface) of the electrode device and/or on the distal end surface of the electrode device for better detection of the cardiac electric signal and/or temperature. It is more preferable that both distal and lateral surfaces of the electrode device are provided with microelectrode mounting holes, and that microelectrodes 3 are provided in these microelectrode mounting holes. Further, the micro-electrode 3 is provided with a hole for placing a TC wire (temperature sensor wire).

Referring to fig. 1, the medical catheter further comprises a handle assembly 103 and a pulling device (not shown), the handle assembly 103 being connected to the proximal end of the tube 8, the pulling device being arranged inside the tube 8. The handle assembly 103 is used for controlling the traction device to adjust the position and the direction of the head electrode group 101. Further, the handle assembly 103 comprises a bending control pushing piece 9 and a handle 10; the bending control pushing piece 9 is arranged at the near end of the tube body 8 and is positioned between the tube body 8 and the handle 10; the bending control pushing piece 9 controls the traction device to pull, so that the bendable section of the tube body 8 is bent, and the head electrode group 101 is guided to be close to the target tissue.

Preferably, the catheter tip 100 further comprises a pressure sensor, and the magnitude and direction of the pressure of the catheter tip 100 against the target tissue are sensed by the pressure sensor of the catheter tip 100, and the fitting strength or whether fitting is performed is evaluated. With further reference to fig. 3, the pressure sensor includes an elastic tube 104 and at least one strain gauge 105, the at least one strain gauge 105 being disposed on the elastic tube 104. The at least one strain gauge 105 is used for sensing the deformation of the elastic tube 104 to output a varying electrical signal according to the deformation of the elastic tube 104, 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 105 is three, and the three strain gauges 105 are uniformly arranged along the circumferential direction of the elastic tube body 104, and may be arranged on the same circumference or different circumferences.

Referring back to fig. 1, the handle assembly 103 includes a signal port 11 and an energy source port 12. The microelectrode 3 and the strain gauge 105 are both connected with a signal port 11 at the near end of the handle 10 through a lead, and the signal port 11 can instantly reflect the performance of the catheter (including information such as temperature, pressure, electrocardiosignals and the like) through a signal display instrument. With reference to fig. 2c, a plurality of lead channels 16 are disposed in the tube 8, and both the lead and the TC wire of the microelectrode 3 pass through the lead channels 16 and then are connected to the signal port 11 at the proximal end of the handle 10. Each head electrode in the head electrode group 101 is also connected with a lead wire, and the lead wire passes through the lead wire channel 16 to be connected with the energy source port 12 at the proximal end of the handle 10. In this embodiment, the inner sides of the first and second head electrodes 1 and 2 are connected to a lead, and preferably, a conductor is provided when the head electrode group 101 is formed, specifically: a conductor (a lead or a core rod) is led out from the inner walls of the first head electrode 1 and the second head electrode 2 respectively, penetrates through the first insulator 4-1 and extends along the axial direction of the first insulator 4-1 for connecting with the rear-end energy port 12. Correspondingly, the ring electrode of the ring electrode set 102 is connected with a lead wire, and the lead wire is also connected with the signal port 11 at the proximal end of the handle through a lead wire channel 16. The wire passage 16 may be one or more.

In addition, the embodiment of the utility model also provides an ablation system, which comprises the medical catheter and an energy output device, wherein the energy output device is used for selectively outputting ablation energy to the electrode device in the medical catheter, and the ablation energy comprises pulse ablation and/or radio frequency ablation energy. In some embodiments, the energy output device is a radiofrequency meter that delivers high frequency current to at least some of the set of head electrodes 101 through the energy port 12. In some embodiments, the energy output device is a pulse generator that delivers a pulsed current to at least two head electrodes in the set of head electrodes 101 through the energy source port 12, forming a pulsed field ablation. 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.

Preferably, the catheter tip 100 comprises a plurality of filling holes (not shown), and the tube 8 is provided with a filling channel 14 (fig. 2c), wherein the filling channel 14 is communicated with the filling holes. The number of infusion orifices is preferably a plurality, preferably uniformly arranged, the infusion orifices being generally arranged along the circumference of the head electrode. The filling hole may be provided on the head electrode, or may be provided on the first insulator 4-1. During the actual ablation procedure, a cooling medium, such as saline or other substances, may optionally be used to cool the target tissue or the electrode at the catheter tip 100 to more precisely control the temperature of the target tissue or the electrode at the catheter tip. The method specifically comprises the following steps: the cooling medium is poured through a cooling medium pouring port 13 at the proximal end of the handle 10, so that the cooling medium flows along a pouring channel 14 in the tube body 8 to a pouring hole on the catheter head end 100. In addition, a bending control channel 15 is further arranged inside the pipe body 8, bending control cables are distributed in the bending control channel 15, and the bending control cables are connected with the bending control pushing piece 9.

Referring next to fig. 4a to 4c in conjunction with fig. 2a and 2b, in some embodiments, the head electrode group 101 has a hyperbolic structure, such as a co-or counter-rotating double helix, for example, the first head electrode 1 and the second head electrode 2 are both spirally extending curved structures, the first head electrode 1 and the second head electrode 2 are coaxial and spaced apart from each other to form a double helix, and the two helices are simultaneously spirally extending in the same or opposite directions along the axis of the first insulator 4-1. Meanwhile, the first insulator 4-1 has a concave structure, the concave structure is a curved surface shape, the curved surface shape may be a spiral curved surface or a wave-shaped curved surface, and the first and second head electrodes 1 and 2 are mounted at the concave structure of the first insulator 4-1 and fixedly connected with the first insulator 4-1. In addition, a lead wire is respectively led out from the inner sides (i.e. the sides close to the axes of the first insulators) of the first head electrode 1 and the second head electrode 2, and the lead wires of the head electrodes penetrate through the first insulators 4-1 and then enter a lead wire channel 16 in the tube body 8 to be connected with the energy source port 12 at the proximal end of the handle 10.

It should be understood that the head electrode group 101 adopts a spiral extending curve structure design, which not only ensures the requirement that the positive and negative electrodes are attached to the target tissue simultaneously during the ablation of the pulsed electric field, but also ensures that the head of the electrode is more flexible than the common electrode, is more suitable for the requirement of attaching to the tissue during the ablation, and has good attaching effect.

Referring to fig. 5a and 5b, the catheter tip 100 of the medical catheter provided in this embodiment can realize simultaneous attachment of the two electrodes at different attachment positions, and the catheter tip 100 can realize simultaneous attachment of the two electrodes to the target tissue 17 (including lateral attachment, head end attachment, etc.) in any case, and the catheter tip 100 can realize simultaneous attachment of the two electrodes to the target tissue 17, so that the target tissue is ablated more thoroughly and the ablation effect is better. In more detail, as shown in fig. 6a, in a front view, i.e. the head (i.e. the distal end face, also having a transverse cross-section) of the set of head electrodes 101 covers both head electrodes; as shown in fig. 6b, the left side surface of the head electrode group 101 also covers two head electrodes in the left side view; as shown in fig. 6c, in a top view, the upper side of the head electrode group 101 also covers two head electrodes; as shown in fig. 6d, a longitudinal section taken along the line C-C shown in fig. 6C also covers two head electrodes. Thus, at any time and at any location, the interface of the outer surface of catheter tip 100 with target tissue 17 covers both tip electrodes. Therefore, the bipolar discharge end is formed by the first head electrode 1 and the second head electrode 2 being rotationally fitted.

Referring back to fig. 4c, the first insulator 4-1 may be at least partially curved, and specifically includes a rod-shaped body 411 and a curved structure 412 wound on the rod-shaped body 411, the curved structure 412 may be a spiral structure or a wave-shaped structure, a concave structure 413 is formed between the curved structure 412 and the rod-shaped body 411, the shape of the concave structure 413 may be a spiral concave structure or a wave-shaped concave structure, the concave structure 413 is just matched with the first head electrode 1 and the second head electrode 2, and the two head electrodes are insulated from each other after being mounted at the concave structure 413. In addition, several wire channels may be formed inside, at the side, or between the inside and outside of the rod-shaped body 411 for arranging wires. Preferably, the head electrode is connected to the first insulator 4-1 by micro precision injection molding. In addition, the second insulator 4-2 can be sleeved on the first insulator 4-1, and more preferably, the first insulator 4-1 and the second insulator 4-2 are of an integral structure. In this embodiment, the second insulator 4-2 ensures insulation between the first and second head electrodes 1 and 2 and the first ring electrode 1. Further, at least a part of the first head electrode 1, at least a part of the second head electrode 2, at least a part of the first insulator 4-1 and the micro-electrodes 3 are arranged in a tai chi pattern on the distal end face of the electrode device, and in particular, refer to fig. 2b and 6 a.

In other embodiments, referring to fig. 7a to 7c, the head electrode group 101 may further include three head electrodes, namely a first head electrode 1, a second head electrode 2 and a third head electrode 18, each of which has a spiral structure, and the three head electrodes are coaxial and spaced from each other to form a triple helix, and the triple helices are simultaneously helical in the same direction or in the opposite direction. In the present embodiment, the three spirals are arranged in parallel in the same direction and extend spirally along the axis of the first insulator. Further, the first head electrode 1, the second head electrode 2 and the third head electrode 18 are arranged along the circumferential direction of the first insulator 4-1 and arranged on the distal end face of the electrode device to form a three-lobe structure, the first insulator 4-1 is arranged between every two adjacent head electrodes, and preferably, one micro-electrode 3 is arranged on each lobe of the distal end face of the electrode device. It should be understood that the first insulator 4-1 is not shown in fig. 7a and 7 b.

Further, each head electrode includes a spiral section 101a and a straight line section 101b (refer to fig. 7a), the straight line section 101b is located at one end or both ends of the spiral section 101b, and accordingly, the recess structure 413 on the first insulator 4-1 also has a spiral section and a straight line section. The helical section 101a of the head electrode mates with the helical section of the recessed structure 413 and the straight section 101b mates with the straight section of the recessed structure 413. It should be noted that the head electrode may be a variable diameter screw or a screw with a constant diameter, and is specifically adjusted according to actual needs. In addition, the spiral shape and the size of each head electrode are not limited, and the head electrodes can be arranged according to the actual operation requirement. And here, make a plurality of head electrodes arrange under the condition of the same electrical parameter through double helix or more spirals, the electric field distribution is more even, and the ablation effect is better.

Referring to fig. 8 in conjunction with fig. 9a to 9d, in another embodiment, another configuration of the head electrode group 101 is provided, the head electrode group 101 also includes a first head electrode 1 and a second head electrode 2; in distinction, the first head electrode 1 comprises a top cover 111 and a plurality of first branches 112 (a plurality of which comprises at least two) distributed (preferably evenly distributed) along the circumference of the top cover 111, preferably the top cover 111 has a smooth outer surface, such as a circular arc-shaped outer surface. The top cover 111 and/or the first branch 112 are/is preferably provided with microelectrode mounting holes for placing the microelectrodes 3; the second head electrode 2 comprises a bottom 211 (preferably circular ring-shaped) and a plurality of second branches 212 distributed along the circumference of the bottom 211 (preferably uniformly distributed), and the second branches 212 are preferably provided with microelectrode mounting holes for placing the microelectrodes 3; the number of the first branches 112 of the first head electrode 1 is the same as that of the second branches 212 of the second head electrode 2, for example, the number of the branches is 2 to 4; the first head electrode 1 and the second head electrode 2 are nested such that one first branch 112 is disposed between every two adjacent second branches 212, and one second branch 212 is disposed between every two adjacent first branches 112. And/or the first branch 112 of the first head electrode 1 and the second branch 212 of the second head electrode 2 are disposed parallel to each other. In addition, a first insulator 4-1 is provided at the junction of the first and second head electrodes 1 and 2 for insulating the first and second head electrodes 1 and 2. Preferably, the head electrode group 101 and the first insulator 4-1 are combined to form a cylinder with a smooth distal end portion, and the distal end portion of the cylinder is in smooth transition, so that the head electrodes are free from edges and corners, and adverse point discharge, electric arc generation and ablation effect influence are prevented. In this embodiment, the head electrode group 101 and the first insulator 4-1 are preferably integrally combined by integral precision injection molding. Further, the distance (i.e., the insulation pitch) at the joint of the first head electrode 1 and the second head electrode 2 is also preferably 0.15mm to 1.5 mm.

In conclusion, the pulse discharge can be realized through the electrode device to perform pulse field ablation, and the pulse field ablation can effectively reduce the muscle stimulation to a patient. In addition, the utility model can realize that a plurality of head electrodes simultaneously cling to the target tissue at any time and any position in the whole ablation process, and the pulse electric field covers the target tissue rather than blood as much as possible, thereby achieving better ablation effect. In addition, the utility model can realize energy selection in the ablation process, namely, in the ablation process, an operator can select a more suitable energy mode to carry out ablation according to the complexity of a surgical site, the actual shape of a patient or the experience of a doctor, so that the operation is more flexible and convenient. The utility model is compatible with radio frequency ablation and pulse ablation, can achieve more accurate and comprehensive ablation, greatly reduces the complexity of the operation, enhances the operability of the operation, shortens the operation time and reduces 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 in any way, and that the innovation of the present invention is derived from cardiac ablation, but those skilled in the art will appreciate that the present invention is also applicable to ablation of different sites such as renal artery ablation, bronchial ablation, etc., and the present invention is not limited thereto.

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, for example, the present invention is not limited to a spiral head electrode set, nor to a head electrode set with 2U-shaped head electrodes nested, in any way, as long as it can ensure that at least two electrodes can be simultaneously placed against the target tissue at any position during the ablation process. 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 utility model is also applicable to mapping catheter techniques.

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 utility model, which should also be considered as a protection scope of the utility model. 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 (19)

1. An electrode device, characterized by comprising a head electrode group, wherein the head electrode group comprises at least two head electrodes which are connected through a first insulator; and the electrode device is provided with a specific area, and any cross section and any longitudinal section of the specific area comprise at least two sections of the head electrode.

2. The electrode device of claim 1, wherein the specific region is defined by a distal end face of the electrode device and at least a portion of an outer peripheral surface of the electrode device.

3. The electrode assembly of claim 1 wherein each of said head electrodes is configured in a helically extending curvilinear configuration, at least two of said head electrodes being coaxial and spaced apart from one another, at least two of said head electrodes each extending helically along an axis of said first insulator;

the first insulator is provided with a concave structure, the concave structure is in a curved surface shape, and at least two head electrodes are arranged at the concave structure.

4. The electrode device of claim 3, wherein the first insulator includes a rod-shaped body and a curved structure wound around the rod-shaped body, the curved structure and the rod-shaped body forming the recessed structure therebetween; each head electrode is matched and fixed with the concave structure.

5. The electrode device of claim 1, wherein the number of the head electrodes is two, and two of the head electrodes are nested; one of the head electrodes comprises a top cover and at least two first branches connected with the top cover, the at least two first branches are distributed along the circumferential direction of the top cover, the other head electrode comprises a bottom and at least two second branches connected with the bottom, and the at least two second branches are distributed along the circumferential direction of the bottom;

the number of the first branches is the same as that of the second branches, one first branch is arranged between every two adjacent second branches, and one second branch is arranged between every two adjacent first branches; and/or the first branch and the second branch are arranged in parallel with each other.

6. The electrode device according to any one of claims 1 to 5, wherein the electrode device further comprises at least one microelectrode for acquiring intracardiac signals, the microelectrode and the head electrode being insulated from each other, and/or wherein the electrode device further comprises at least one temperature sensor for acquiring the temperature of the target tissue, the temperature sensor and the head electrode being insulated from each other.

7. The electrode device according to claim 6, wherein when the electrode device comprises a plurality of said microelectrodes, the plurality of said microelectrodes are disposed on a distal end face of the electrode device and/or on an outer peripheral surface of the electrode device.

8. The electrode device of claim 7, wherein the number of said head electrodes is two, and two of said microelectrodes are provided on the distal end face of said electrode device;

at least part of two of the head electrodes, at least part of one of the first insulators, and two of the microelectrodes are arranged in a tai chi pattern on a distal end face of the electrode device, the first insulator being disposed between the two head electrodes.

9. The electrode device according to claim 7, wherein the number of the head electrodes is three, three head electrodes are arranged along the circumference of the first insulator and arranged on the distal end face of the electrode device to form a three-petal structure, the first insulator is arranged between every two adjacent head electrodes, and a micro-electrode is arranged on each petal of the distal end face of the electrode device.

10. The electrode device according to any one of claims 1 to 5, wherein the electrode device further comprises a plurality of perfusion holes for releasing a cooling medium; the filling hole is provided on the first insulator or the head electrode.

11. The electrode assembly of any one of claims 1-5 wherein the insulation spacing between at least two of said head electrodes is between 0.15mm and 1.5 mm.

12. The electrode device according to any of claims 1-5, wherein the electrode device has a smooth outer surface and/or wherein the electrode device is of cylindrical construction.

13. The electrode assembly of any one of claims 1-5 wherein at least two of said head electrodes are injection molded with said first insulator.

14. The electrode assembly of claim 13 wherein the inside of each of said head electrodes is provided with a conductor penetrating into and extending axially along said first insulator.

15. 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 14.

16. The medical catheter of claim 15, 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.

17. The medical catheter of claim 15, wherein the catheter tip further comprises a ring electrode set including at least one ring electrode, the at least one ring electrode being mounted on the tube, and the head electrode set and the ring electrode set being insulated from each other by a second insulator.

18. An ablation system comprising a medical catheter as in any of claims 15-17, 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.

19. The ablation system of claim 18, wherein the energy output device is a radiofrequency instrument and/or a pulse generator;

when the energy output device is a radiofrequency instrument, the energy output device is used for outputting radiofrequency current to at least one head electrode in the medical catheter;

when the energy output device is a pulse generator, the energy output device is used for outputting pulse current to at least two head electrodes in the medical catheter.

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