Electrode Sets, Medical Catheters, and Ablation Systems

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, the energy output device is used to output ablation energy to the electrode device; the medical catheter comprises a tube body, the tube body comprises a catheter head end, the catheter head end is provided with an electrode device; the electrode device comprises a head electrode group, the head electrode group comprises at least two head electrodes, the at least two head electrodes are connected by a first insulator; and the electrode device has a specific area, any cross section and any longitudinal section of the specific area contain sections of at least two head electrodes; thereby achieving more accurate and comprehensive ablation and improving the ablation effect.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and more particularly to an electrode device, a medical catheter and an ablation system. Background Art

[0002] Tissue ablation is a treatment method commonly used to treat arrhythmias, including atrial fibrillation. Abnormal electrical propagation in myocardial tissue is ablated and / or abnormal electrical conduction is interrupted to repair tissue. Radiofrequency ablation is currently a common method used clinically to treat arrhythmias such as atrial fibrillation. Radiofrequency ablation is a method of releasing radiofrequency current to cause coagulative necrosis of local endocardial and subendocardial myocardium, and achieves the effect of ablation in the form of heat release, but it has certain limitations. It lacks selectivity in destroying tissue in the ablation area and relies on the adhesion force of the catheter, so it may cause damage to the adjacent esophagus, coronary arteries, and phrenic nerves.

[0003] With the development of pulse technology, pulsed electric fields are used as an efficient and safe ablation energy for the treatment of cardiac ablation. Unlike radiofrequency ablation, the irreversible electroporation damage of microsecond pulses to the myocardial membrane is a non-thermal biological effect that can effectively avoid damage to blood vessels, nerves, and esophagus. The existing field of cardiac ablation mostly uses single energy ablation technologies such as radiofrequency and pulsed electric fields, which cannot flexibly complement each other's strengths. For example, radiofrequency ablation has been precipitated for many years. On the one hand, the ablation technology is relatively mature, and on the other hand, doctors have rich experience in radiofrequency ablation. Compared with radiofrequency ablation, pulse technology is in the development stage, and its tissue selectivity can largely make up for the shortcomings of radiofrequency ablation.

[0004] However, current ablation catheters such as PFA ablation catheters (PFA stands for pulsed field ablation) or radiofrequency ablation catheters are not compatible with both radiofrequency ablation and pulsed electric field ablation. The ablation method is single, which reduces the flexibility of the operation and increases the complexity of the operation. In addition, the current PFA ablation catheter cannot achieve good adhesion with the tissue, which easily causes the tissue to be ablated incompletely. It is also impossible to achieve adhesion between the electrode and the tissue at any position during the entire ablation process, and it is impossible to ensure that the ablation energy field covers the target tissue in a concentrated manner, which affects the ablation effect. Summary of the invention

[0005] In order to solve at least one of the above technical problems, the purpose of the present invention is to provide an electrode device, a medical catheter and an ablation system, which at least solves the problem that the current ablation energy field, especially the pulsed electric field, cannot concentrate on covering the target tissue, resulting in insufficient ablation of the target tissue.

[0006] To achieve the above-mentioned purpose, according to the first aspect of the present invention, there is provided an electrode device, comprising a head electrode group, wherein the head electrode group comprises at least two head electrodes, and the at least two head electrodes are connected by a first insulator; and the electrode device has a specific area, and any cross-section and any longitudinal section of the specific area contain cross-sections of at least two of the head electrodes.

[0007] Optionally, the specific area is defined by a distal surface of the electrode device and at least a portion of an outer peripheral surface of the electrode device.

[0008] 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 from each other, and at least two of the head electrodes both extend spirally along the axis of the first insulator;

[0009] The first insulator has a recessed structure, the recessed structure is in a curved shape, and at least two head electrodes are installed at the recessed structure.

[0010] Optionally, the first insulator includes a rod-shaped body and a curved structure wound around the rod-shaped body, the recessed structure is formed between the curved structure and the rod-shaped body; each of the head electrodes is fixedly matched with the recessed structure.

[0011] Optionally, the number of the head electrodes is two, and the two head electrodes are nested; one of the head electrodes includes a top cover and at least two first branches connected to the top cover, and at least two of the first branches are distributed along the circumference of the top cover; the other head electrode includes a bottom and at least two second branches connected to the bottom, and at least two of the second branches are distributed along the circumference of the bottom;

[0012] The number of the first branches and the second branches is the same, 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 parallel to each other.

[0013] Optionally, the electrode device also includes at least one microelectrode for collecting intracardiac signals, and the microelectrode and the head electrode are insulated from each other, and / or the electrode device also includes at least one temperature sensor for collecting the temperature of the target tissue, and the temperature sensor and the head electrode are insulated from each other.

[0014] Optionally, when the electrode device includes a plurality of the microelectrodes, the plurality of microelectrodes are arranged on a distal surface of the electrode device and / or an outer peripheral surface of the electrode device.

[0015] Optionally, the number of the head electrodes is two, and two microelectrodes are arranged on the distal surface of the electrode device;

[0016] At least part of the two head electrodes, at least part of one first insulator and the two microelectrodes are arranged in a Tai Chi pattern on the distal surface of the electrode device, and the first insulator is disposed between the two head electrodes.

[0017] Optionally, the number of the head electrodes is three, and the three head electrodes are arranged along the circumference of the first insulator and on the distal surface of the electrode device to form a three-petal structure, the first insulator is arranged between each adjacent two head electrodes, and a microelectrode is arranged on each petal of the distal surface of the electrode device.

[0018] Optionally, the electrode device further comprises a plurality of injection holes for releasing cooling medium; the injection holes are arranged on the first insulator or on the head electrode.

[0019] Optionally, the insulation distance between at least two of the head electrodes is 0.15 mm to 1.5 mm.

[0020] Optionally, the electrode device has a smooth outer surface, and / or the electrode device is a cylindrical structure.

[0021] Optionally, at least two of the head electrodes are connected to the first insulator by injection molding.

[0022] Optionally, a conductor is disposed on the inner side of each of the head electrodes, and the conductor penetrates into the first insulator and extends along the axial direction of the first insulator.

[0023] To achieve the above object, according to a second aspect of the present invention, a medical catheter is provided, comprising a tube body, wherein the tube body comprises a catheter head end, and the catheter head end is provided with any of the electrode devices described above.

[0024] Optionally, the catheter head also includes an elastic tube body and at least one strain gauge, and at least one strain gauge is arranged on the elastic tube body; the electrode device is connected to the elastic tube body and is coaxially arranged.

[0025] Optionally, the catheter head end further includes a ring electrode group, the ring electrode group includes at least one ring electrode, at least one of the ring electrodes is mounted on the tube body, and the head electrode group and the ring electrode group are insulated from each other by a second insulator.

[0026] To achieve the above-mentioned object, according to a third aspect of the present invention, there is provided an ablation system, comprising any one of the medical catheters described above, and the ablation system further comprises an energy output device, wherein the energy output device is used to selectively output ablation energy to the medical catheter, and the ablation energy comprises pulse ablation and / or radiofrequency ablation energy.

[0027] Optionally, the energy output device is a radio frequency instrument and / or a pulse generator;

[0028] When the energy output device is a radio frequency instrument, the energy output device is used to output radio frequency current to at least one head electrode in the medical catheter;

[0029] When the energy output device is a pulse generator, the energy output device is used to output pulse current to at least two head electrodes in the medical catheter.

[0030] The electrode device, medical catheter and ablation system provided by the present invention have the following advantages:

[0031] First, the electrode device has a specific area, and any cross section and any longitudinal section of the specific area include sections of at least two head electrodes. With such a structure, when the electrode device is in contact with the target tissue, the electrode device and the target tissue can achieve at least two head electrodes in contact with the target tissue at the same time in any case, so that the ablation of the target tissue is more thorough or the potential mapping is more accurate;

[0032] Second, the above-mentioned medical catheter can realize the selection of energy during the ablation process after applying the above-mentioned electrode device, such as radiofrequency ablation or pulse ablation. That is, during the ablation process, the surgical operator can choose a more suitable energy method to perform ablation according to the complexity of the surgical site, the actual situation of the patient or the experience of the doctor, thereby improving the flexibility of the ablation process, greatly reducing the complexity of the operation, increasing the operability of the operation, effectively shortening the operation time, and reducing the risks during the operation;

[0033] Third, the above-mentioned medical catheter can realize pulse discharge of the head electrode group, which can effectively reduce muscle stimulation to the patient and improve the safety of ablation. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0035] Figure 1 is a schematic structural diagram of a medical catheter in a preferred embodiment of the present invention;

[0036] Figure 2a yes Figure 1 An enlarged view of the catheter tip is shown;

[0037] Figure 2b yes Figure 2a The catheter tip is shown in a left view along the AA direction;

[0038] Figure 2c yes Figure 2a A transverse cross-sectional view of the catheter tip along the BB direction, wherein the section line is not shown;

[0039] Figure 3 is a schematic diagram of the structure of a pressure sensor in a preferred embodiment of the present invention;

[0040] Figure 4a is an exploded schematic diagram of two head electrodes in a head electrode group in a preferred embodiment of the present invention;

[0041] Figure 4b It is a schematic diagram of assembling two head electrodes in a head electrode group in a preferred embodiment of the present invention;

[0042] Figure 4c is a schematic structural diagram of a first insulator in a head electrode group in a preferred embodiment of the present invention;

[0043] Figure 5a It is a schematic diagram of the catheter tip in contact with tissue in a preferred embodiment of the present invention;

[0044] Figure 5b It is a schematic diagram of the catheter tip in a preferred embodiment of the present invention being in contact with tissue after the position is adjusted;

[0045] Figure 6a Schematic diagram of the relative positions of two head electrodes in a front view in a preferred embodiment of the present invention;

[0046] Figure 6b Schematic diagram of the relative positions of two head electrodes in the left view in a preferred embodiment of the present invention;

[0047] Figure 6c Schematic diagram of the relative positions of two head electrodes in a top view in a preferred embodiment of the present invention;

[0048] Figure 6d For along Figure 6c Schematic diagram of the section along the CC line;

[0049] Figure 7a is a front view of a head electrode group in a preferred embodiment of the present invention;

[0050] Figure 7b is a stereoscopic diagram of a head electrode group in a preferred embodiment of the present invention;

[0051] Figure 7c is a top view of a head electrode assembly in a preferred embodiment of the present invention;

[0052] Figure 8 It is an exploded schematic diagram of two head electrodes of a head electrode group in another preferred embodiment of the present invention;

[0053] Figure 9a It is a schematic diagram of the relative positions of two head electrodes in a front view in another preferred embodiment of the present invention;

[0054] Figure 9b It is a schematic diagram of the relative positions of two head electrodes in a left view in another preferred embodiment of the present invention;

[0055] Fig.9c A schematic diagram of the relative positions of two head electrodes in a top view in another preferred embodiment of the present invention;

[0056] Figure 9d It is a three-dimensional schematic diagram of the relative positions of two head electrodes in another preferred embodiment of the present invention.

[0057] The following are the descriptions of the reference numerals:

[0058] 100-catheter tip; 101-head electrode group; 101a-spiral segment; 101b-straight segment; 1-first head electrode; 111-top cover; 112-first branch; 2-second head electrode; 211-bottom; 212-second branch; 18-third head electrode; 3-microelectrode; 3-1 first microelectrode; 3-2-second microelectrode; 102-ring electrode group; 5-first ring electrode; 6-second ring electrode; 7-third ring electrode ;4-1-first insulator;411-rod-shaped body;412-curved structure;413-recessed structure;4-2-second insulator;8-tube body;103-handle assembly;9-bending control push piece;10-handle;11-signal port;12-energy port;13-cooling medium infusion port;14-infusion channel;15-bending control channel;16-wire channel;17-target tissue;104-elastic tube body;105-strain gauge. DETAILED DESCRIPTION

[0059] In order to make the content of the present invention more clear and easy to understand, the present invention is further described below in conjunction with the drawings of the specification. Of course, the present invention is not limited to this specific embodiment, and general replacements known to those skilled in the art are also covered within the scope of protection of the present invention. Secondly, the present invention is described in detail using schematic diagrams, but these schematic diagrams are only for the convenience of detailing examples of the present invention and should not be used as limitations of the present invention.

[0060] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0061] Herein, "proximal" and "distal" refer to the relative orientation, relative position, and direction of elements or actions relative to each other from the perspective of a doctor using the product. Although "proximal" and "distal" are not restrictive, "proximal" generally refers to the end of the product that is close to the doctor during normal operation, and "distal" generally refers to the end that first enters the patient's body. As used in this specification, the singular forms "a", "an", and "the" include plural objects unless the content clearly indicates otherwise. As used in this specification, the term "or" is generally used in a sense including "and / or" unless the content clearly indicates otherwise. In addition, the term "circumferential" generally refers to the direction around the axis of the medical catheter; the term "longitudinal" generally refers to the direction parallel to the axis of the medical catheter; the term "transverse" generally refers to the direction perpendicular to the axis of the medical catheter.

[0062] One object of the present invention is to provide an electrode device, which includes a head electrode group, the head electrode group includes at least two head electrodes, the at least two head electrodes are connected by a first insulator to be insulated from each other; and the electrode device has a specific area, any cross section and any longitudinal section of the specific area contain cross sections of at least two head electrodes. The specific area of ​​the electrode device can be set in a part or all of the entire electrode device. In a preferred embodiment, the specific area is defined by the distal surface of the electrode device and at least part of the outer peripheral surface of the electrode device. "Distal surface" refers to the end surface of the distal end of the electrode device. With such a structure, when a medical catheter using the electrode device, such as an ablation catheter, is in contact with the target tissue, the electrode device and the target tissue can achieve at least two head electrodes in contact with the target tissue at the same time in any case, so that the ablation of the target tissue is more thorough or the potential mapping is more accurate. It should be understood that the head electrode is not limited to an electrode for ablation, but can also be an electrode for mapping.

[0063] Another object of the present invention is to provide a medical catheter, which can be an ablation catheter or a mapping catheter. The medical catheter includes a tube body, and the tube body includes a catheter head end, and the catheter head end is provided with an electrode device of the present invention. When the head electrode in the electrode device of the present invention is used for ablation, radio frequency energy ablation can be used, and pulsed electric field ablation can be used, that is, the head electrode can accept pulse current to achieve the purpose of pulse ablation, and can also accept high-frequency current to achieve the purpose of radio frequency ablation. Therefore, the medical catheter of the present invention can realize the selection of energy in the ablation process, that is, during the ablation process, the surgical operator can choose a more suitable energy method to implement ablation according to the complexity of the surgical site, the actual situation of the patient or the experience of the doctor, thereby improving the flexibility of the ablation process, greatly reducing the complexity of the operation, increasing the operability of the operation, effectively shortening the operation time, and reducing the risk during the operation. More specifically, during radiofrequency ablation, one can choose to electrically conduct one head electrode to receive high-frequency current, or more head electrodes can be turned on to receive high-frequency current; and during pulse ablation, at least one pair of head electrodes can be electrically conducted, or more head electrodes can be turned on; pulse ablation is preferably bipolar ablation, that is, the polarities of the two head electrodes in a pair of head electrodes are opposite. It should also be understood that the medical catheter of the present invention is not limited to cardiac ablation, but can also be used for ablation of other parts (such as kidneys) or diseases. Therefore, during the entire ablation process, at any time and any position, when the medical catheter contacts the tissue, at least two head electrodes can be simultaneously attached to the target tissue, so that the ablation energy field, especially the pulsed electric field, covers the target tissue as much as possible instead of the blood, to achieve a better ablation effect or a better potential mapping effect.

[0064] Furthermore, the catheter head end also includes an elastic tube body and at least one strain gauge, at least one strain gauge is arranged on the elastic tube body, and the electrode device is connected to the elastic tube body and arranged coaxially. At this time, the medical catheter forms a pressure sensor at the distal end, which can monitor the force on the end of the catheter. The present invention does not limit the structure of the elastic tube body. It should be known that the elastic tube body can be given excellent elasticity by various means, such as an elastic plastic tube or rubber tube (polymer material) or a metal tube. The metal tube is preferably made of a metal material with shape memory function, including but not limited to nickel-titanium alloy. The strain gauge is preferably three strain gauges, and at least three strain gauges are evenly arranged in the circumferential direction of the elastic tube body. The strain gauge can be a conventional single-bridge strain gauge or a half-bridge strain gauge, or a shear gauge, a strain flower or other unconventional strain gauge can be selected. The corresponding type of strain gauge is mainly selected according to the structure of the elastic tube body, and there is no special restriction. Therefore, when the electrode device contacts the blood vessel wall or tissue surface, the distal end of the catheter can perform tissue ablation or potential mapping through the head electrode, and can also obtain the magnitude and direction of the contact force when in contact with the tissue. Moreover, when the elastic tube is subjected to the contact force, the electrical signal of the pressure sensor changes, and the magnitude and direction of the contact force can be obtained based on the changed electrical signal. That is, the strain gauge senses the deformation of the elastic tube to output a changed electrical signal.

[0065] Another object of the present invention is to provide an ablation system, comprising the medical catheter of the present invention, and the ablation system further comprises an energy output device, which may be a radio frequency device and / or a pulse generator, and the energy output device is used to selectively output ablation energy to the medical catheter. For example, when the energy output device is a radio frequency device, a high-frequency current is sent to an electrode device in the medical catheter to achieve radio frequency ablation; when the energy output device is a pulse generator, a pulse current is sent to an electrode device in the medical catheter to achieve pulse ablation.

[0066] Furthermore, the catheter tip also includes a ring electrode group, the ring electrode group includes at least one ring electrode, at least one of the ring electrodes is mounted on the tube body or the elastic tube body, and the head electrode group and the ring electrode group are insulated from each other by a second insulator. Here, the ring electrode group is used for potential mapping, such as mapping the site of arrhythmia. The present invention does not limit the number of ring electrodes, which can be one, two, three or more.

[0067] Furthermore, the medical catheter of the present invention also includes a traction device and a handle assembly. The traction device is arranged inside the tube body. The handle assembly is connected to the proximal end of the tube body and is used to control the traction device to adjust the position and direction of the head electrode group. In more detail, the traction device includes a bending control cable, the medical catheter has a bendable section, the bending control cable is connected to the bendable section and the handle assembly, and the bending control cable controls the bending of the bendable section to adjust the position and direction of the head electrode group, so that the head electrode group reaches various complex and fine tissue structures, and then the ablation energy is applied to the target tissue through the head electrode group. Preferably, the electrode device is also used to extract intracardiac electrocardiogram signals. In this case, the electrode device also includes at least one microelectrode for collecting intracardiac signals, and at least one of the microelectrodes is insulated from all the head electrodes. The present invention does not limit the number of microelectrodes, which can be one, two, three or more. Preferably, the electrode device also has a temperature detection function, which is used to monitor the actual temperature of the tissue during the ablation process to adjust the output of the ablation energy according to the feedback temperature. In this case, the electrode device also includes at least one temperature sensor, which can be arranged on the head electrode or the microelectrode and insulated from these electrodes. More preferably, the temperature sensor is integrated with the microelectrode. The so-called "integrated into one" means that the temperature sensor is arranged on the microelectrode, and preferably the temperature sensor is arranged inside the microelectrode so that the microelectrode has its own temperature detection function.

[0068] The electrode device, medical catheter and ablation system proposed in the present invention are further described below in conjunction with the accompanying drawings and preferred embodiments. Although the following description uses the head electrode group including two or three head electrodes and an ablation catheter as an illustration, this illustration does not constitute a limitation of the present invention. The solution of the present invention is also applicable to the case of more head electrodes, and to the case of a mapping catheter or other medical catheters.

[0069] Figure 1 is a schematic diagram of the structure of a medical catheter in a preferred embodiment of the present invention, Figure 2a yes Figure 1 An enlarged view of the catheter tip is shown. Figure 2b yes Figure 2a The view of the catheter tip along the AA direction is shown. Figure 2c yes Figure 2a The catheter tip is shown in a transverse cross-sectional view along the BB direction.

[0070] refer to Figure 1 , Figure 2a to Figure 2c This embodiment provides a medical catheter that is compatible with radiofrequency and pulsed field ablation. The medical catheter includes a tube body 8, and the tube body 8 includes a catheter head end 100. The catheter head end 100 is used to abut against the target tissue to implement ablation or potential mapping. It should be understood that Figure 1The portion encircled by the dotted line is the catheter tip 100. For ease of understanding, Figure 1 The catheter tip 100 is shown enlarged.

[0071] The catheter tip 100 is provided with an electrode device, the electrode device includes a head electrode group 101, the head electrode group 101 includes at least two head electrodes, and the junction of the at least two head electrodes is provided with a first insulator, and the first insulator is used to insulate the head electrodes from each other. In particular, the head electrode group 101 has a specific area, the specific area is used to abut against the target tissue, and any cross section and any longitudinal section of the specific area contain cross sections of at least two head electrodes. It should be understood that any cross section of the specific area contains the cross sections of at least two head electrodes, and any longitudinal section of the specific area contains the longitudinal sections of at least two head electrodes. Preferably, the head electrode group 101 includes at least two head electrodes on the outer surface (mainly the distal end surface) in the transverse direction, and at least part of the outer surface (i.e., the peripheral surface) in the circumferential direction includes at least two head electrodes. In the preferred embodiment, the specific area is defined by the distal end surface of the electrode device and at least part of the peripheral surface of the electrode device. In this way, during the entire ablation process, when the catheter head end 100 is in contact with the target tissue, at least two head electrodes can be in contact with the target tissue at the same time, so that the ablation energy field (preferably a pulsed electric field) covers the target tissue as much as possible instead of blood, achieving a better ablation effect, making the ablation more thorough, and thus improving the ablation effect. In other words, the medical catheter of this 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 during the operation.

[0072] 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 to achieve bipolar pulse discharge, thereby contacting the target tissue for ablation or mapping, and abutting against the tissue at any position circumferentially of the catheter head end 100. The first head electrode 1 and the second head electrode 2 can both abut against the target tissue at the same time to the greatest extent, and the two head electrodes can also abut against the target tissue at the distal end of the catheter head end 100. In other embodiments, the two head electrodes can be used as energy input electrodes simultaneously or selectively during radiofrequency ablation. Of course, in other embodiments, the polarity of the two head electrodes during pulse discharge may also be the same, thereby achieving unipolar pulse discharge.

[0073] Further, the catheter tip 100 also includes a ring electrode group 102 for target tissue potential mapping, in which case the ring electrode group 102 is mainly used for potential mapping, and the head electrode group 101 is used for tissue ablation. Of course, in other embodiments, the ring electrode group 102 can also be used for tissue ablation, the head electrode group 101 is used for potential mapping, or the ring electrode group 102 is used in conjunction with the head electrode group 101 for ablation or potential mapping. The ring electrode group 102 includes one ring electrode or multiple ring electrodes (multiple means at least two). Optionally, the ring electrode group 102 includes three ring electrodes, which are respectively a first ring electrode 5, a second ring electrode 6 and a third ring electrode 7, and these ring electrodes are axially spaced on the tube body of the catheter tip 100 and insulated from each other. In addition, 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 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 the first insulator 4-1 or connected separately, and further, the second insulator 4-2 is annular and sleeved on the first insulator 4-1, so 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 is preferably tightly fitted with the proximal surface of the head electrode group 101 and the distal surface of the first ring electrode 5.

[0074] Preferably, the electrode device as a whole is a non-angular cylinder, that is, it has a smooth outer surface, so as to prevent adverse tip discharge, avoid the generation of arcs, and affect 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). Further, the electrode device is a cylindrical structure, and the distal end of the electrode device has a smooth transition to the outer peripheral surface. In addition, when there are two head electrodes, the insulation spacing between the two head electrodes is preferably 0.15mm to 1.5mm, for example, the insulation spacing at the junction of the first head electrode 1 and the second head electrode 2 is 0.15mm to 1.5mm. Similarly, when there are three or more head electrodes, the insulation spacing between any two adjacent head electrodes is 0.15mm to 1.5mm. Here, it should be understood that since the pulse electric field is released between the two electrodes as positive and negative electrode signals, if the distance between the head electrodes is too small, electric sparks and low-temperature plasma effects are likely to occur; if the distance between the head electrodes is too far, it will affect the electric field strength; in view of these problems, the distance between the two head electrodes is designed to be within the above range, within which the electric field energy intensity can be guaranteed and no ionization occurs. Preferably, the head electrode group 101 and the first insulator 4-1 are integrally injection molded in a micro-precision injection molding manner, with high connection strength and strong stability. In another embodiment, the head electrode group 101 and the first insulator 4-1 can also be connected by machining, which is not limited here.

[0075] Further preferably, the head electrode group 101 also includes at least one microelectrode 3 for collecting intracardiac signals and / or target tissue temperature. At least one of the microelectrodes 3 can be installed on the head electrode, or on the first insulator 4-1, and the microelectrode 3 and the head electrode are insulated from each other. In this embodiment, the microelectrode 3 is installed on the head electrode, for example, a microelectrode mounting hole is provided on the head electrode, and the microelectrode 3 is placed in the microelectrode mounting hole and is insulated from the head electrode. For example: the microelectrode 3 and the head electrode are bonded by glue, so as to be electrically isolated from each other by the colloid, for example, the microelectrode 3 is fixed on the first head electrode 1 or the second head electrode 2 using medical insulating glue. Or a non-metallic insulator is added between the microelectrode 3 and the head electrode to achieve isolation from each other. Preferably, the number of the microelectrodes 3 is 2 to 8. In this embodiment, the number of the microelectrodes 3 is 4, which are two first microelectrodes 3-1 and two second microelectrodes 3-2. Optionally, the two first microelectrodes 3-1 are located on the distal surface of the head electrode group 101, and the two second microelectrodes 3-2 are located on the peripheral surface (side) of the head electrode group 101. However, the number and arrangement of the microelectrodes 3 are not limited to this example. In other embodiments, a plurality of microelectrodes 3 are arranged on the distal surface and / or peripheral surface of the electrode device. The microelectrode 3 is made of metal and is used to detect ECG signals. Preferably, a temperature sensor is provided in the microelectrode 3, and the temperature sensor is used to monitor the actual temperature of the tissue during ablation. In other embodiments, the temperature sensor can also be arranged in the head electrode and insulated from each other. The present invention has no special requirements for the position of the microelectrode 3. In order to better detect ECG signals and / or temperature, the microelectrode 3 is preferably arranged on the side (peripheral surface) of the electrode device and / or on the distal surface of the electrode device. More preferably, microelectrode mounting holes are provided on the distal end surface and the side surface of the electrode device, and microelectrodes 3 are provided in these microelectrode mounting holes. Furthermore, microelectrodes 3 are provided with holes for placing TC wires (temperature sensor wires).

[0076] refer to Figure 1 The medical catheter further includes a handle assembly 103 and a traction device (not shown), wherein the handle assembly 103 is connected to the proximal end of the tube body 8, and the traction device is disposed inside the tube body 8. The handle assembly 103 is used to control the traction device to adjust the position and direction of the head electrode group 101. Further, the handle assembly 103 includes a bending control push piece 9 and a handle 10; the bending control push piece 9 is disposed at the proximal end of the tube body 8, between the tube body 8 and the handle 10; the traction device is controlled by the bending control push piece 9 to bend the bendable section of the tube body 8, thereby guiding the head electrode group 101 to approach the target tissue.

[0077] Preferably, the catheter head end 100 further includes a pressure sensor, through which the pressure sensor of the catheter head end 100 senses the size and direction of the pressure of the catheter head end 100 against the target tissue, and evaluates the strength of the contact or whether it is in contact. Figure 3 The pressure sensor includes an elastic tube body 104 and at least one strain gauge 105, and at least one strain gauge 105 is disposed on the elastic tube body 104. The at least one strain gauge 105 is used to sense the deformation of the elastic tube body 104, so as to output a changing electrical signal according to the deformation of the elastic tube body 104, thereby obtaining the pressure of the catheter head end 100 against the target tissue according to the changing electrical signal. Preferably, the number of the strain gauges 105 is three, and the three strain gauges 105 are evenly arranged along the circumference of the elastic tube body 104, and can be arranged on the same circumference or on different circumferences.

[0078] Return to reference Figure 1 The handle assembly 103 includes a signal port 11 and an energy port 12. The microelectrode 3 and the strain gauge 105 are connected to the signal port 11 at the proximal end of the handle 10 through a wire. The signal port 11 can instantly reflect the catheter performance (including temperature, pressure, ECG signal and other information) through a signal display. Figure 2c , a plurality of wire channels 16 are arranged in the tube body 8, and the wires of the microelectrode 3 and the TC wires are connected to the signal port 11 at the proximal end of the handle 10 after passing through the wire channels 16. Each head electrode in the head electrode group 101 is also connected to a wire, and the wire passes through the wire channel 16 to be connected to the energy port 12 at the proximal end of the handle 10. In this embodiment, the inner side of the first head electrode 1 and the second head electrode 2 are connected to a wire. Preferably, a conductor is provided when the head electrode group 101 is formed, specifically: a conductor (wire or core rod) is led out from the inner wall of each of the first head electrode 1 and the second head electrode 2, and the conductor penetrates the first insulator 4-1 and extends along the axial direction of the first insulator 4-1, and is used to connect to the rear end energy port 12. Correspondingly, the ring electrodes in the ring electrode group 102 are connected to wires, and the wires also pass through the wire channels 16 to be connected to the signal port 11 at the proximal end of the handle. There can be one or more wire channels 16.

[0079] In addition, an embodiment of the present invention further provides an ablation system, comprising the medical catheter and an energy output device, wherein the energy output device is used to selectively output ablation energy to the electrode device in the medical catheter, wherein the ablation energy includes pulse ablation and / or radiofrequency ablation energy. In some embodiments, the energy output device is a radiofrequency instrument, which transmits high-frequency current to at least part of the head electrodes in the head electrode group 101 through the energy port 12. In some embodiments, the energy output device is a pulse generator, which transmits pulse current to at least two head electrodes in the head electrode group 101 through the energy port 12 to form pulse field ablation. In other embodiments, the energy output device is a radiofrequency pulse generator, which integrates radiofrequency energy or pulse energy into one device, or a device that emits a pulse signal after processing radiofrequency energy, and then transmits these energies to the medical catheter to achieve ablation, which is not limited in the present application.

[0080] Preferably, the catheter tip 100 includes a plurality of perfusion holes (not shown in the figure), and the interior of the tube body 8 is provided with a perfusion channel 14 ( Figure 2c ), the perfusion channel 14 is connected to the perfusion hole. The number of perfusion holes is preferably multiple, preferably evenly arranged, and the perfusion holes are usually arranged along the circumference of the head electrode. The perfusion hole can be set on the head electrode, and can also be set on the first insulator 4-1. In the actual ablation process, a cooling medium such as saline or other substances can be selectively used to cool the target tissue or the electrode at the catheter head end 100 to more accurately control the temperature of the target tissue or the temperature of the electrode on the catheter head end. Specifically: the cooling medium is perfused through the cooling medium perfusion port 13 at the proximal end of the handle 10, so that the cooling medium flows along the perfusion channel 14 in the tube body 8 to the perfusion hole on the catheter head end 100. In addition, a bending control channel 15 is also provided inside the tube body 8, and a bending control cable is arranged in the bending control channel 15, and the bending control cable is connected to the bending control push piece 9.

[0081] Next reference Figures 4a to 4c , and combined with Figure 2a and Figure 2bIn some embodiments, the head electrode group 101 is a hyperbolic structure, such as a double helix in the same direction or in the opposite direction. For example, the first head electrode 1 and the second head electrode 2 are both spirally extended curved structures. The first head electrode 1 and the second head electrode 2 are coaxial and spaced from each other to form a double helix. The two helices spiral in the same direction or in the opposite direction at the same time. These head electrodes spirally extend along the axis of the first insulator 4-1. At the same time, the first insulator 4-1 has a concave structure, and the concave structure is a curved surface shape. The curved surface shape can be a spiral curved surface or a wavy curved surface. The first head electrode 1 and the second head electrode 2 are installed at the concave structure of the first insulator 4-1 and are fixedly connected to the first insulator 4-1. In addition, a wire is led out from the inner side of the first head electrode 1 and the second head electrode 2 (i.e., the side close to the axis of the first insulator). After passing through the first insulator 4-1, the wire of the head electrode enters the wire channel 16 in the tube body 8 and is connected to the energy port 12 at the proximal end of the handle 10.

[0082] It should be understood that the head electrode group 101 adopts a spirally extended curved structure design, which not only ensures that the positive and negative electrodes are simultaneously attached to the target tissue during pulsed electric field ablation, but also makes the electrode head more flexible than ordinary electrodes, more suitable for the need of ablation and close to tissue, and has a good adhesion effect.

[0083] refer to Figure 5a and Figure 5b The catheter tip 100 of the medical catheter provided in this embodiment can achieve dual electrodes simultaneously abutting against the target tissue 17 at different abutting positions, and the catheter tip 100 can achieve dual electrodes simultaneously abutting against the target tissue 17 in any situation (including side abutting, head end abutting, etc.). Such a setting makes the target tissue ablation more thorough and the ablation effect better. In more detail, as Figure 6a As shown, in the front view, the head (i.e., the distal end surface, also having a transverse section) of the head electrode group 101 covers two head electrodes; Figure 6b As shown, in the left view, the left side of the head electrode group 101 is also covered with two head electrodes; Figure 6c As shown, in the top view, the upper side of the head electrode group 101 also covers two head electrodes; Figure 6d As shown, along Figure 6c The longitudinal section cut along the CC line shown also covers two head electrodes. Therefore, at any time and any position, the outer surface of the catheter head end 100 and the contact surface with the target tissue 17 are covered with two head electrodes. Therefore, the first head electrode 1 and the second head electrode 2 are rotated together to form a bipolar discharge end.

[0084] Return to reference Figure 4c, the first insulator 4-1 may be at least partially curved, specifically including a rod-shaped body 411 and a curved structure 412 wound around the rod-shaped body 411, the curved structure 412 may be a spiral structure or a wavy structure, a recessed structure 413 is formed between the curved structure 412 and the rod-shaped body 411, the shape of the recessed structure 413 may be a spiral recessed structure or a wavy recessed structure, the recessed structure 413 just matches the first head electrode 1 and the second head electrode 2, after the two head electrodes are installed at the recessed structure 413, the two head electrodes can be insulated. In addition, a number of wire channels may be formed inside, on the side, or between the inner and outer sides 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 may be sleeved on the first insulator 4-1, and more preferably, the first insulator 4-1 and the second insulator 4-2 are an integrated structure. In this embodiment, the insulation of the first head electrode 1 and the second head electrode 2 from the first ring electrode 1 is ensured by the second insulator 4-2. Further, at least a portion of the first head electrode 1, at least a portion of the second head electrode 2, at least a portion of the first insulator 4-1 and the microelectrode 3 are arranged on the distal surface of the electrode device according to a Tai Chi pattern. Figure 2b and Figure 6a .

[0085] In other embodiments, reference Figures 7a to 7c , the head electrode group 101 may also include three head electrodes, namely the first head electrode 1, the second head electrode 2 and the third head electrode 18, each head electrode is a spiral structure, the three head electrodes are coaxial and spaced apart from each other to form a triple helix, and the three helices spiral in the same direction or opposite directions at the same time. In this embodiment, the three spirals are arranged in parallel in the same direction and extend spirally along the axis of the first insulator. Furthermore, the first head electrode 1, the second head electrode 2 and the third head electrode 18 are arranged along the circumference of the first insulator 4-1 and arranged on the distal surface of the electrode device to form a three-petal structure, and the first insulator 4-1 is arranged between every two adjacent head electrodes, and preferably a microelectrode 3 is arranged on each petal of the distal surface of the electrode device. It should be understood that Figure 7a and Figure 7b The first insulator 4 - 1 is not shown.

[0086] Further, each head electrode includes a spiral segment 101a and a straight segment 101b (refer to Figure 7a), the straight segment 101b is located at one end or both ends of the spiral segment 101b, and accordingly, the recessed structure 413 on the first insulator 4-1 also has a spiral segment and a straight segment. The spiral segment 101a of the head electrode cooperates with the spiral segment of the recessed structure 413, and the straight segment 101b cooperates with the straight segment of the recessed structure 413. It should be noted that the head electrode can be a spiral of variable diameter or a spiral of constant diameter, which is adjusted according to actual needs. In addition, there is no limitation on the spiral shape and size of each head electrode, and they can be set according to actual surgical needs. Here, by using a double helix or more spirals to arrange multiple head electrodes under the condition of the same electrical parameters, the electric field distribution is more uniform and the ablation effect is better.

[0087] refer to Figure 8 , and combined with Figures 9a to 9d In another embodiment, a head electrode group 101 of another structure is provided, and the head electrode group 101 also includes a first head electrode 1 and a second head electrode 2; the difference is that the first head electrode 1 includes a top cover 111 and a plurality of first branches 112 (including at least two) distributed circumferentially (preferably evenly distributed) along the top cover 111, and preferably the top cover 111 has a smooth outer surface, such as an arc-shaped outer surface. The top cover 111 and / or the first branch 112 are preferably provided with microelectrode mounting holes for placing the microelectrode 3; the second head electrode 2 includes a bottom 211 (preferably in a circular shape) and a plurality of second branches 212 distributed circumferentially (preferably evenly distributed) along the bottom 211, and the second branches 212 are preferably provided with microelectrode mounting holes for placing the microelectrode 3; the number of the first branches 112 of the first head electrode 1 and the second branches 212 of the second head electrode 2 are the same, such as the number of branches is 2 to 4; the first head electrode 1 and the second head electrode 2 are nested, so that a first branch 112 is provided between each two adjacent second branches 212, and a second branch 212 is provided between each 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 arranged parallel to each other. In addition, a first insulator 4-1 is provided at the connection between the first head electrode 1 and the second head electrode 2 to isolate the first head electrode 1 and the second head electrode 2. Preferably, the head electrode group 101 and the first insulator 4-1 are combined into a cylinder with a smooth distal end, and the distal end of the cylinder has a smooth transition, while ensuring that each head electrode has no edges and corners, preventing unfavorable tip discharge, arcing, and affecting the ablation effect. In this embodiment, the head electrode group 101 and the first insulator 4-1 are preferably combined into a whole by integral precision injection molding. In addition, the distance between the first head electrode 1 and the second head electrode 2 (i.e., the insulation spacing) is also preferably 0.15mm to 1.5mm.

[0088] In summary, the present invention can realize pulse discharge to perform pulse field ablation through the electrode device, and pulse field ablation can effectively reduce muscle stimulation to the patient. Moreover, the present invention can realize that multiple head electrodes are simultaneously attached to the target tissue at any time and any position during the entire ablation process, so that the pulse electric field covers the target tissue as much as possible instead of the blood, thereby achieving a better ablation effect. In addition, the present invention can realize energy selection during the ablation process, that is, during the ablation process, the surgical operator can choose a more suitable energy method to implement ablation according to the complexity of the surgical site, the actual condition of the patient or the doctor's experience, making the operation more flexible and convenient. Moreover, the present invention is compatible with radiofrequency ablation and pulse ablation, which 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 during the operation.

[0089] It should be understood that the above description is only a preferred embodiment of the present invention and is not any formal or substantial limitation to the present invention. Moreover, although the innovation of the present invention is derived from cardiac ablation, those skilled in the art can understand that the present invention can also be applied to ablation of different parts such as renal artery ablation and bronchial ablation, and the present invention is not limited to this.

[0090] The above is only a preferred embodiment of the present invention, and does not constitute any formal or substantial limitation to the present invention. For example, the present invention is not limited to a spiral-shaped head electrode group, nor is it limited to a head electrode group with two U-shaped head electrodes nested. In short, as long as it can be ensured that at least two electrodes can be simultaneously attached to the target tissue when the head electrode group contacts the target tissue at any position during the entire ablation process, it can be used. Moreover, although the innovation of the present invention comes from the field of ablation catheters and ablation technology, those skilled in the art can understand that the present invention can also be applied to mapping catheter technology.

[0091] It should be pointed out that ordinary technicians in this technical field can make several improvements and supplements without departing from the method of the present invention, and these improvements and supplements should also be regarded as the protection scope of the present invention. Any technician familiar with this profession can make some changes, modifications and evolutions of the technical content disclosed above without departing from the spirit and scope of the present invention, which are equivalent embodiments of the present invention; at the same time, any changes, modifications and evolutions of any equivalent changes made to the above embodiments based on the essential technology of the present invention are still within the scope of the technical solution of the present invention.

Claims

1. An electrode device, characterized in that: It includes a head electrode group, which includes at least two head electrodes, and the at least two head electrodes are connected by a first insulator; and the electrode device has a specific area, and any cross-section and any longitudinal section of the specific area contain cross-sections of at least two head electrodes; the specific area is defined by the distal surface of the electrode device and at least part of the outer peripheral surface of the electrode device.

2. The electrode device according to claim 1, characterized in that Each of the head electrodes is configured as a spirally extending curved structure, at least two of the head electrodes are coaxial and spaced from each other, and at least two of the head electrodes both spirally extend along the axis of the first insulator; The first insulator has a recessed structure, the recessed structure is in a curved shape, and at least two head electrodes are installed at the recessed structure.

3. The electrode device according to claim 2, characterized in that The first insulator includes a rod-shaped body and a curved structure wound around the rod-shaped body, wherein the concave structure is formed between the curved structure and the rod-shaped body; each of the head electrodes is fixedly matched with the concave structure.

4. The electrode device according to claim 1, characterized in that There are two head electrodes, and the two head electrodes are nested; one of the head electrodes includes a top cover and at least two first branches connected to the top cover, and at least two of the first branches are distributed along the circumference of the top cover; the other head electrode includes a bottom and at least two second branches connected to the bottom, and at least two of the second branches are distributed along the circumference of the bottom; The number of the first branches and the number of the second branches are the same, 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 parallel to each other.

5. The electrode device according to any one of claims 1 to 4, characterized in that: The electrode device also includes at least one microelectrode for collecting intracardiac signals, and the microelectrode and the head electrode are insulated from each other, and / or the electrode device also includes at least one temperature sensor for collecting the temperature of the target tissue, and the temperature sensor and the head electrode are insulated from each other.

6. The electrode device according to claim 5, characterized in that When the electrode device includes a plurality of the microelectrodes, the plurality of microelectrodes are arranged on the distal end surface of the electrode device and / or the outer peripheral surface of the electrode device.

7. The electrode device according to claim 6, characterized in that 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 the two head electrodes, at least part of one first insulator and the two microelectrodes are arranged in a Tai Chi pattern on the distal surface of the electrode device, and the first insulator is disposed between the two head electrodes.

8. The electrode device according to claim 6, characterized in that The number of the head electrodes is three, and the three head electrodes are arranged along the circumference of the first insulator and on the distal 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 surface of the electrode device.

9. The electrode device according to any one of claims 1 to 4, characterized in that: The electrode device further comprises a plurality of injection holes for releasing cooling medium; the injection holes are arranged on the first insulator or on the head electrode.

10. The electrode device according to any one of claims 1 to 4, characterized in that: The insulation distance between at least two of the head electrodes is 0.15 mm to 1.5 mm.

11. The electrode device according to any one of claims 1 to 4, characterized in that: The electrode device has a smooth outer surface, and / or the electrode device is a cylindrical structure.

12. The electrode device according to any one of claims 1 to 4, characterized in that: At least two of the head electrodes are connected to the first insulator by injection molding.

13. The electrode device according to claim 12, characterized in that A conductor is disposed inside each of the head electrodes. The conductor penetrates the first insulator and extends along the axial direction of the first insulator.

14. A medical catheter, characterized in that: It comprises a tube body, the tube body comprises a catheter head end, and the catheter head end is provided with an electrode device according to any one of claims 1-13.

15. The medical catheter according to claim 14, characterized in that The catheter head also includes an elastic tube body and at least one strain gauge, and at least one strain gauge is arranged on the elastic tube body; the electrode device is connected to the elastic tube body and is coaxially arranged.

16. The medical catheter according to claim 14, characterized in that The catheter head end also includes a ring electrode group, which includes at least one ring electrode. At least one of the ring electrodes is installed on the tube body, and the head electrode group and the ring electrode group are insulated from each other by a second insulator.

17. An ablation system, characterized in that: The ablation system comprises a medical catheter as described in any one of claims 14 to 16, and the ablation system further comprises an energy output device, wherein the energy output device is used to selectively output ablation energy to the medical catheter, wherein the ablation energy comprises pulse ablation and / or radiofrequency ablation energy.

18. The ablation system according to claim 17, characterized in that: The energy output device is a radio frequency instrument and / or a pulse generator; When the energy output device is a radio frequency instrument, the energy output device is used to output radio frequency 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 to output pulse current to at least two head electrodes in the medical catheter.

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