CN113729923B

CN113729923B - Surface ablation electrode catheter and ablation equipment

Info

Publication number: CN113729923B
Application number: CN202111162735.0A
Authority: CN
Inventors: 罗中宝; 代聪育; 张朕华; 孙佳宝
Original assignee: Shanghai Remedicine Co ltd
Current assignee: Shanghai Ruidao Medical Technology Co ltd
Priority date: 2021-09-30
Filing date: 2021-09-30
Publication date: 2022-07-12
Anticipated expiration: 2041-09-30
Also published as: CN113729923A

Abstract

The present disclosure relates to a surface ablation electrode catheter and an ablation apparatus, the surface ablation electrode catheter including: an outer tube for forming a receiving cavity and an electrode arm portion including at least three electrode arms, the electrode arms being respectively provided with an electrode portion for ablation and each including a first spline segment, a second spline segment, a third spline segment and a fourth spline segment, wherein at least a portion of each electrode arm assumes a wire-like contracted state when disposed in the receiving cavity; and an extended state when at least a portion of each electrode arm is disposed outside the receiving cavity, with the first and second spline segments in the first face and the third spline segment and the fourth spline segment not in the first face, wherein the first spline segment includes a portion of the electrode arm extending from the tip to a first point in the first face at a maximum distance from the tip and the second spline segment includes a portion extending from the first point to a second point away from the first face.

Description

Surface ablation electrode catheter and ablation equipment

Technical Field

The present disclosure relates to the field of medical devices, and more particularly to a planar ablation electrode catheter and an ablation device.

Background

Atrial Fibrillation (AF) is a common cardiac arrhythmia affecting the lives of over 3300 million people worldwide. Radiofrequency ablation and cryoablation are two common methods currently used clinically to treat cardiac arrhythmias such as atrial fibrillation. Both types of ablation must be sufficiently damaging to the arrhythmic tissue or to substantially interfere with or isolate abnormal electrical conduction in the myocardial tissue, while excessive ablation may affect surrounding healthy tissue as well as neural tissue, but insufficient ablation may not serve to block abnormal electrical conduction. Therefore, it is critical to produce a suitable ablation zone.

The radio frequency ablation adopts point-by-point ablation, the operation time is long, the requirement on the catheter operation level of an operator (such as a doctor) is high, discomfort can be caused due to the long time during the operation of a patient, and the problems of pulmonary vein stenosis and the like easily occur after the operation. In addition, radiofrequency ablation can damage the cardiac endothelial surface, activate the extrinsic coagulation cascade and lead to coke and thrombosis, which in turn can lead to systemic thromboembolism. It follows that the application of radio frequency energy to target tissue can have an effect on non-target tissue, for example, the application of radio frequency energy to atrial wall tissue can cause damage to the digestive system, such as the esophagus, or the nervous system. Radiofrequency ablation may also lead to scarring of the tissue, further leading to embolization problems. Cryoablation has a high probability of causing phrenic nerve damage, and epicardial freezing near the coronary arteries can also lead to thrombosis and progressive coronary stenosis.

A new and recent technique for treating atrial fibrillation is the pulsed electric field technique, which applies a brief high voltage to the tissue cells and can produce a local high voltage electric field of several hundred volts per centimeter. The local high electric field destroys the cell membrane by forming pores in the cell membrane, wherein the applied electric field is above the cell threshold so that the perforations do not close, and such electroporation is irreversible, thereby allowing biomolecular material to exchange across the membrane, resulting in cell necrosis or apoptosis. Since different tissue cells have different voltage penetration thresholds, the high voltage pulse technique can selectively treat myocardial cells (relatively low threshold) without affecting other non-target cellular tissues (e.g., nerves, esophagus, blood vessels, and blood); meanwhile, the pulse technology cannot generate a thermal effect because the time for releasing energy is very short, so that the problems of tissue damage, pulmonary vein stenosis and the like are avoided. Therefore, the pulsed electric field technology is increasingly applied to clinical treatment due to its advantages of non-thermal and cell selectivity.

However, the main current ablation electrode catheters are single-point ablation and ring ablation catheters adapting to the shape of the pulmonary vein ostium, including spherical, cage, basket or ring electrode catheters, and these forms of electrode catheters have the disadvantages that: the electric field range generated by the single-point ablation or annular ablation electrode catheter is too small, the requirement on the precision of the operation is higher, and the operation is time-consuming; the catheter designed according to the shape of the pulmonary vein opening can only be used for pulmonary vein ablation, and the treatment area and the indications are relatively limited.

Disclosure of Invention

In view of the deep understanding of the problems existing in the background art, that is, the range of the electric field generated by the conventional electrode catheter is too small, or the ablation area and the application limitation are large, the inventor of the present disclosure provides a surface ablation catheter in the present application, which can generate an electric field in a large range, has a large ablation range, can satisfy not only small-range and fine ablation (such as pulmonary veins, atrial flutter, atrial septa, etc.), but also can be applied to large-range ablation (such as atrial walls, hypertrophic cardiac muscle, etc.), and has a wide application range.

Specifically, a first aspect of the present disclosure proposes a planar ablation electrode catheter including:

an outer tube configured to form a receiving cavity; and

an electrode arm including at least three electrode arms on which electrode portions for ablation are respectively provided and each including a first spline segment, a second spline segment, a third spline segment, and a fourth spline segment,

wherein when at least a portion of each electrode arm is disposed within the receiving cavity, the at least a portion assumes a contracted state; and when at least a portion of each of the electrode arms is disposed outside of the receiving cavity, the at least a portion assumes an extended state, and wherein, in the extended state, the first spline segment and the second spline segment are in a first plane and the third spline segment and the fourth spline segment are not in the first plane, wherein the first spline segment includes a portion of the electrode arm extending from a tip of the electrode arm to a first point in the first plane at a furthest distance from the tip, and the second spline segment includes a portion extending from the first point to a second point away from the first plane.

Different from the electrode catheter in the prior art, in the surface ablation electrode catheter disclosed by the disclosure, the front end part of the electrode arm has a part similar to a J shape or even a U shape in an extending state to form an ablation surface, namely, the front end part extends outwards from the center and then extends a section towards the center in a reverse direction, so that the range of the ablation surface is remarkably increased, and further the surface ablation electrode catheter disclosed by the disclosure can generate an electric field in a larger range, has a large ablation range, can meet small-range and fine ablation (such as pulmonary veins, atrial flutter, atrial septa and the like), can be applied to large-range ablation (such as atrial walls, hypertrophic cardiac muscle and the like), and has a wide application range.

In one embodiment according to the present disclosure, the fourth spline segment extends outwardly from the axial center of the face ablation electrode catheter to determine a closeness of the first face, and wherein the third spline segment is configured to connect the fourth spline segment and the second spline segment. In this way, the fourth spline segment can control the degree of expansion or the degree of convergence of the leading-end electrode arm, so that the shape of expansion of the electrode arm can be indirectly controlled by setting the expanded shape of the fourth spline segment, and the size of the electric field range formed after the electrode arm is expanded can be controlled.

In one embodiment according to the present disclosure, the area ablation electrode catheter further includes an electrode arm drive configured to drive the electrode arm to move between the inner and outer positions of the receiving cavity. In this way, the electrode arm for forming the area ablation can be conveniently moved outside the accommodating cavity, and simple operation and control are realized.

In one embodiment according to the present disclosure, the ends of the at least three electrode arms are mechanically connected by a woven mesh. More preferably, in one embodiment according to the present disclosure, the mesh grid has a regular polygonal shape and is made of an elastic material. Therefore, on one hand, the shape of the ablation surface formed by the electrode arm is relatively controllable, and on the other hand, certain elasticity is ensured, so that the shape of the ablation surface formed by the electrode arm has certain variation possibility.

In one embodiment according to the present disclosure, the area ablation electrode catheter further comprises: an inner tube located within the receiving cavity; and a central electrode disposed on the mesh and powered via a wire in the inner tube. In this way, the formation of the electric field can be further diversified in order to improve the ablation effect.

In one embodiment according to the present disclosure, the electrode arm further includes: an inner core; a wire routed along an axial direction of the inner core; and an insulating sleeve covering the inner core and the wire, wherein the electrode portion is disposed outside the insulating sleeve, and wherein the wire is connected to the electrode portion at the electrode portion through the insulating sleeve. Preferably, in one embodiment according to the present disclosure, the inner core is made of a memory material or a medical stainless steel material.

Optionally, in an embodiment according to the present disclosure, the electrode portion is provided at the first spline segment and/or the second spline segment on the electrode arm. In this way, an electric field can be formed on the first surface, and targeted tissue ablation can be performed. Alternatively or additionally, in an embodiment according to the present disclosure, the electrode portion is further provided at the third spline segment and/or the fourth spline segment on the electrode arm. In this way, an ablation electric field can be formed on the first surface and in the region other than the first surface, and flexible configuration can be performed for different scenes.

In one embodiment according to the present disclosure, the polarity of the electrode portion is set to one of the following configurations: the electrode parts on the same electrode arm have the same polarity; the polarities of the electrode parts on the adjacent spline sections of the same electrode arm are different; and the polarities of the electrode parts on the same spline segment on the two adjacent electrode arms are different. In this way, flexible configuration can be carried out according to specific ablation targets, and dynamic configuration of the electric field range and the electric field direction is realized, so that the ablation effect is improved.

Preferably, in one embodiment according to the present disclosure, the number of the electrode arms is eight and each electrode arm has the same shape in the extended state. It will be appreciated by those skilled in the art that more or less than eight electrode arms are also within the scope of the present disclosure, such as six or ten electrode arms.

In one embodiment according to the present disclosure, the area ablation electrode catheter further comprises: a bending adjustment device that adjusts a deflection direction of the surface ablation electrode catheter by controlling a pull wire in the outer tube, wherein the bending adjustment device includes: a first housing portion and a second housing portion, a first wheel disc and a second wheel disc, wherein the first housing portion and the first wheel disc are fixedly connected and the second housing portion and the second wheel disc are fixedly connected, and wherein the first wheel disc has a first fixing portion and fixes a proximal end of a first pull wire to the first wheel disc at the first fixing portion, and the second wheel disc has a second fixing portion and fixes a proximal end of a second pull wire to the second wheel disc at the second fixing portion. In this way, it is possible to control the deflection direction, for example, upward deflection or downward deflection, of the electrode line connected thereto by means of the bending device.

In one embodiment according to the present disclosure, a locking mechanism is provided between the first housing portion and the second housing portion or between the first wheel disc and the second wheel disc, the locking mechanism being configured to lock the first housing portion and the second housing portion or the first wheel disc and the second wheel disc to each other, wherein the locking mechanism includes: a slide rail provided on one of the first housing portion and the second housing portion; and a slider provided on the other of the first housing portion and the second housing portion. In the case of the first housing part and the second housing part being locked to one another, the first wheel and the second wheel are likewise locked to one another, so that the first wheel and the second wheel can be actuated together in order to control the deflection direction of the electrode line connected thereto, for example, whether it is deflected upwards or downwards.

Furthermore, a second aspect of the present disclosure proposes an ablation apparatus comprising: a pulse signal generator configured to generate a pulse signal; and the surface ablation electrode catheter according to the first aspect of the disclosure, wherein an electrode part of the surface ablation electrode catheter is electrically connected with an output end of the pulse signal generator.

In summary, in the area ablation electrode catheter proposed according to the present disclosure, unlike the electrode catheter in the prior art, the front end portion of the electrode arm has a portion similar to a J shape or even a U shape in the extended state to form an ablation area, that is, after extending outward from the center, the front end portion of the electrode arm further extends toward the center in a reverse direction by a section, which significantly increases the range of the ablation area, so that the area ablation electrode catheter disclosed according to the present disclosure can generate an electric field in a wider range, and the ablation range is wider, and thus, the area ablation electrode catheter can not only meet small-range and fine ablation (such as pulmonary veins, atrial flutter, atrial septa, etc.), but also can be applied to large-range ablation (such as atrial wall, hypertrophic myocardium, etc.), and has a wide application range.

Drawings

Embodiments are shown and described with reference to the drawings. These drawings are provided to illustrate the basic principles and thus only show the aspects necessary for understanding the basic principles. The figures are not to scale. In the drawings, like reference numerals designate similar features.

Fig. 1A illustrates an elevation view of the front end of a face ablation electrode catheter 100 according to one embodiment of the present disclosure;

FIG. 1B illustrates a side view of the front end of the face ablation electrode catheter 100 in accordance with the embodiment illustrated in FIG. 1A of the present disclosure;

fig. 2 illustrates an elevation view of the front end of a face ablation electrode catheter 200 according to another embodiment of the present disclosure;

fig. 3A illustrates an elevation view of the front end of a face ablation electrode catheter 300 according to yet another embodiment of the present disclosure;

FIG. 3B illustrates a perspective view of the front end of the face ablation electrode catheter 300 according to the embodiment illustrated in FIG. 3A of the present disclosure;

FIG. 4 illustrates an internal schematic view of a bend tuning device 370 according to one embodiment of the present disclosure;

FIG. 5 shows a schematic view of two discs in the sweep apparatus according to the embodiment shown in FIG. 4 of the present disclosure;

fig. 6 shows a schematic view of a bending knob 373 in the bending apparatus according to the embodiment shown in fig. 4 of the present disclosure; and

fig. 7 is a schematic view of a face ablation electrode catheter 400 in accordance with the present disclosure.

Other features, characteristics, advantages and benefits of the present disclosure will become more apparent from the following detailed description in conjunction with the accompanying drawings.

Detailed Description

In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings, which form a part hereof. The accompanying drawings illustrate, by way of example, specific embodiments in which the disclosure can be practiced. The example embodiments are not intended to be exhaustive of all embodiments according to the disclosure. It is to be understood that other embodiments may be utilized and structural or logical changes may be made without departing from the scope of the present disclosure. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present disclosure is defined by the appended claims.

The technique used in this disclosure to treat atrial fibrillation is a pulsed electric field technique that applies brief high voltages to the target tissue cells that can produce local high voltage electric fields of several hundred volts per centimeter. The local high voltage electric field destroys the cell membrane by forming a puncture in the cell membrane where the applied electric field is above the cell threshold so that the puncture does not reclose, thereby making such electroporation irreversible. The perforation will allow the exchange of biomolecular material across the cell membrane, resulting in necrosis or apoptosis of the cell.

Since different tissue cells have different voltage penetration thresholds, the high voltage pulse technique can selectively treat myocardial cells with relatively low thresholds without affecting other non-target cell tissues, such as nerve cells, esophageal cells, vascular cells, and blood cells. Meanwhile, the time for releasing energy is very short, so that the pulse electric field technology cannot generate obvious thermal effect, and the problems of tissue damage, pulmonary vein stenosis and the like are avoided.

In particular, pulsed electric field (PET) ablation is a non-thermal damage technique, the damage mechanism being the appearance of nano-scale pores in certain cell membranes by high frequency electrical pulses. Potential advantages of the ability of PET ablation techniques to be used for atrial fibrillation ablation include the following: firstly, the PET ablation technology can pertinently select or avoid target tissues by setting different threshold values, so that surrounding tissues can be protected from being damaged; secondly, the PET ablation technology can be rapidly released within a few seconds, namely the treatment time of the cells of the target tissue is short, and the cells are easy to accept by a user; furthermore, compared to cryoablation, PET ablation does not produce coagulation necrosis, thereby reducing the risk of Pulmonary Vein (PV) stenosis.

A schematic view of a portion for forming an electric field, i.e., an electrode arm portion and its surrounding portion of a surface ablation electrode catheter according to the present disclosure is described below with reference to the accompanying drawings. Wherein fig. 1A shows a front view of the front end of the face ablation electrode catheter 100 in accordance with one embodiment of the present disclosure, and fig. 1B shows a side view of the front end of the face ablation electrode catheter 100 in accordance with the embodiment shown in fig. 1A of the present disclosure. As can be seen in fig. 1A and 1B, in accordance with a first embodiment of the present disclosure, i.e., the embodiment shown in fig. 1A and 1B, the front end portion of the face ablation electrode catheter 100 includes at least an outer tube 150 configured to form a receiving lumen, where the outer appearance 150 is seen in only one circle due to the front view of the front end.

In addition, the front end of the ablation electrode catheter 100 needs to further include an electrode arm portion for forming an ablation surface, the electrode arm portion includes at least three electrode arms, and includes eight electrode arms 110 in the embodiment shown in fig. 1A and 1B, generally, the structures of the eight electrode arms 110 are similar, for the sake of simplicity, we refer to the upper left electrode arm 110 to describe, and the other electrode arms 110 have similar structures, and will not be described again. The upper left electrode arm 110 is provided with an electrode part 108 for ablation, namely a rectangular-like square frame part, and the upper left electrode arm 110 and other electrode arms 110 comprise a first spline segment, a second spline segment, a third spline segment and a fourth spline segment, wherein when at least one part (for example, the part at the front end of the electrode arm) of each electrode arm in the plurality of electrode arms is arranged in the accommodating cavity, the at least one part is in a linear-like contracted state (namely, can be well accommodated in the accommodating cavity); and when at least a portion of each of the plurality of electrode arms is disposed outside the receiving cavity (when the receiving cavity formed by the outer tube does not constrain the forward end portion of the electrode arm), the at least a portion assumes an extended state, and wherein, in the extended state, the first spline segment and the second spline segment are in a first plane and the third spline segment and the fourth spline segment are not in the first plane. Referring to fig. 1B, this first face is, for example, a plane perpendicular to the longitudinal axis of the face ablation electrode catheter 100, or a similarly curved face, i.e., the left-hand end face shown in fig. 1B, which can be used to abut the target tissue and then discharge to produce the ablating action. Here, the first spline segment includes a portion of the electrode arm extending from a tip 101 of the electrode arm 110 to a first point 102 in the first face at a farthest distance from the tip 101, and the second spline segment includes a portion extending from the first point 102 to a second point 103 away from the first face (i.e., the end face on the left in fig. 1B).

Unlike the electrode catheter in the prior art, in the surface ablation electrode catheter 100 disclosed in the present disclosure, the front end portion of the electrode arm 110 has a portion similar to a J shape or even a U shape in the extended state to form an ablation surface, that is, after extending outward from the center, the front end portion extends backward to the center by a section, that is, the surface shown at the left end of fig. 1B, which significantly increases the range of the ablation surface, so that the surface ablation electrode catheter 100 disclosed in the present disclosure can generate an electric field in a wider range, the ablation range is wide, and not only small-range and fine ablation (such as pulmonary veins, atrial flutter, atrial septa, etc.) can be satisfied, but also a wide-range ablation (such as atrial wall, hypertrophic myocardium, etc.), and the application range is wide.

Preferably, the facial ablation electrode catheter 100 further includes an electrode arm drive (not shown in fig. 1, which may, for example, be disposed within the outer tube 150) configured to drive the electrode arm between the inner and outer positions within the receiving lumen. In this way, the electrode arm 110 for forming the area ablation can be easily moved outside the receiving cavity, resulting in a simple manipulation.

Furthermore, as can be seen from fig. 1B, the third spline segment and the fourth spline segment included on the electrode arm 110 are respectively portions where the fourth spline segment extends from the center axis 105 to the third point 104 for defining the convergence of the electrode arm, and correspondingly, the third spline segment is a portion connecting the second point 103 and the third point 104, and the third spline segment is only for connecting the second spline segment and the fourth spline segment. In general terms, the fourth spline segment extends outwardly from a center line 105 of the face ablation electrode catheter at the axial center to determine the closeness of the first face, and wherein the third spline segment is configured to connect the fourth spline segment and the second spline segment. In this way, the fourth spline segment can control the degree of expansion or the degree of convergence of the leading-end electrode arm, so that the shape of expansion of the electrode arm can be indirectly controlled by setting the expanded shape of the fourth spline segment, and the size of the electric field range formed after the electrode arm is expanded can be controlled.

Since the tip 101 of the electrode arm 110 of the embodiment shown in fig. 1A is entirely a free end, the electrode arm 110 may undesirably change shape when it is placed against the target tissue. To further determine the deployed shape of the electrode arms 110, a woven mesh may be added at the ends of the electrode arms 110 to relatively fixedly shape the electrode arms when deployed to enhance the deployed shape of the surface ablation electrode catheter in accordance with the present disclosure.

Fig. 2 illustrates an elevation view of the front end of a face ablation electrode catheter 200 according to another embodiment of the present disclosure. As seen in the embodiment shown in fig. 2, the front end portion of the planar ablation electrode catheter 200 includes at least an outer tube (not shown in the drawings, which is a tubular member in which the front end of the planar ablation electrode catheter can be accommodated) configured to form a accommodating cavity. In addition, the front end of the ablation electrode catheter 200 also needs to include an electrode arm portion for forming an ablation surface, the electrode arm portion includes at least three electrode arms, and in the embodiment shown in fig. 2, eight electrode arms 210 are included, generally, the structures of the eight electrode arms 210 are similar, for the sake of simplicity, we refer to the upper left electrode arm 210 to describe, and the other electrode arms 210 have similar structures, and no further description is provided here. The upper left electrode arm 210 is provided with an electrode part 208 for ablation, namely a rectangular-like square frame part, and the upper left electrode arm 210 and other electrode arms 210 comprise a first spline segment, a second spline segment, a third spline segment and a fourth spline segment, wherein when at least one part (for example, the part at the front end of the electrode arm) of each electrode arm in the plurality of electrode arms is arranged in the accommodating cavity, the at least one part is in a linear-like contracted state (namely, can be well accommodated in the accommodating cavity); and when at least a portion of each of the plurality of electrode arms is disposed outside the receiving cavity (when the receiving cavity formed by the outer tube does not constrain the forward end portion of the electrode arm), the at least a portion assumes an extended state, and wherein, in the extended state, the first spline segment and the second spline segment are in a first plane and the third spline segment and the fourth spline segment are not in the first plane. Here, the first spline segment comprises the portion of the electrode arm extending from the tip 201 of the electrode arm to a first point 202 in the first face at the furthest distance from the tip 201, and the second spline segment comprises the portion extending from the first point 202 to a second point 203 away from the first face.

Further, as can be seen in fig. 2, the tips 301 of the plurality of electrode arms 210 are mechanically connected by the woven mesh 220 to relatively fixedly shape the plurality of electrode arms 210 when deployed so as to enhance the deployed shape of the surface ablation electrode catheter 200 according to the present disclosure. More preferably, the mesh grid 220 has a regular polygonal shape and is made of an elastic material. Therefore, on one hand, the shape of the ablation surface formed by the electrode arm is relatively controllable, and on the other hand, certain elasticity is ensured, so that the shape of the ablation surface formed by the electrode arm has certain variation possibility.

Further preferably, in order to enhance the configuration of the electric field of the area ablation electrode catheter disclosed according to the present disclosure, an electrode may be disposed on the woven mesh. Fig. 3A shows a front view of the front end of a face ablation electrode catheter 300 according to yet another embodiment of the present disclosure, while fig. 3B shows a perspective view of the front end of the face ablation electrode catheter 300 according to the embodiment shown in fig. 3A of the present disclosure. As can be seen in fig. 3A and 3B, the front end portion of the facial ablation electrode catheter 300 includes at least an outer tube configured to form a receiving lumen in accordance with the first embodiment of the present disclosure, i.e., the embodiment illustrated in fig. 3A and 3B.

In addition, the front end of the ablation electrode catheter 300 also needs to include an electrode arm portion for forming an ablation surface, the electrode arm portion includes at least three electrode arms, and includes eight electrode arms 310 in the embodiment shown in fig. 3A and 3B, generally, the structures of the eight electrode arms 310 are similar, for simplicity, we refer to the upper left electrode arm 310 to describe, and the other electrode arms 310 have similar structures, which are not described again. The upper left electrode arm 310 is provided with an electrode portion 308 for ablation, namely a rectangular-like square frame portion, and the upper left electrode arm 310 and other electrode arms 310 comprise a first spline segment, a second spline segment, a third spline segment and a fourth spline segment, wherein when at least one part (for example, the part at the front end of the electrode arm) of each electrode arm in the plurality of electrode arms is arranged in the accommodating cavity, the at least one part is in a linear-like contracted state (namely, can be well accommodated in the accommodating cavity); and when at least a portion of each of the plurality of electrode arms is disposed outside the receiving cavity (when the receiving cavity formed by the outer tube does not constrain the forward end portion of the electrode arm), the at least a portion assumes an extended state, and wherein, in the extended state, the first spline segment and the second spline segment are in a first plane and the third spline segment and the fourth spline segment are not in the first plane. Referring to fig. 3B, this first face is, for example, a flat surface perpendicular to the longitudinal axis of the planar ablation electrode catheter 300, or a similarly curved surface, i.e., the upper face shown in fig. 3B, which can be used to abut the target tissue and then discharge to produce the ablating action. Here, the first spline segment includes a portion of the electrode arm extending from a tip 301 of the electrode arm to a first point 302 in the first face at a farthest distance from the tip 301, and the second spline segment includes a portion extending from the first point 302 to a second point 303 away from the first face (i.e., the end face on the upper side in fig. 3B).

Furthermore, in the embodiment illustrated in fig. 3A and 3B according to the present disclosure, the area ablation electrode catheter 300 further includes: an inner tube (located within the outer tube, shown as inner tube 360 in fig. 3B), the inner tube 360 being located within the receiving cavity; and a central electrode 330, the central electrode 330 being disposed on the mesh grid 320 and being supplied with power via a conductive wire 361 in the inner tube 360. In addition, as shown in fig. 3B, a wire protection sleeve 362 is further included between the wire 361 and the inner wall of the inner tube 360 to insulate the inner tube 360 from the wire 361. In this way, the formation of the electric field can be further diversified in order to improve the ablation effect. The other ends of the electrode arms 310 in the embodiment shown in fig. 3A and 3B may be connected together, for example, to form an electrode arm connecting portion 340, and the electrode arm may be restrained by pulling the electrode arm connecting portion 340 into the outer tube 350, so as to be confined, for example, in the outer tube 350 and thus in a contracted state. Conversely, the electrode arm connecting part 340 may be pushed out of the outer tube 350, so that the electrode arm is in an extended state. Further, the lead wire 311 shown in fig. 3B is configured to supply power to the electrode portion in the electrode arm, and the support portion 331 in fig. 3B is configured to fix the center electrode 330.

The

electrode portions

108, 208, 308 and the central electrode 330 in the above embodiments may be made of platinum or platinum-iridium, the lengths of the

electrode portions

108, 208, 308 may be in the range of 1 to 20mm, the lengths of each of the

electrode portions

108, 208, 308 may be uniform or non-uniform, the thicknesses of the

electrode portions

108, 208, 308 and the central electrode 330 may be in the range of 0.01 to 0.1mm, and the number of the electrode portions on each electrode arm may be in the range of 1 to 10.

In the embodiments of the face

ablation electrode catheters

100, 200 and 300 shown in fig. 1A-3B, the electrode arm further comprises: an inner core; a wire routed along an axial direction of the inner core; and an insulating sleeve covering the inner core and the wire, wherein the electrode portion is disposed outside the insulating sleeve, and wherein the wire is connected to the electrode portion at the electrode portion through the insulating sleeve. Preferably, in one embodiment according to the present disclosure, the inner core is made of a memory material or a medical stainless steel material. The inner core can be made of memory alloy or medical stainless steel material or other suitable materials; the section of the wire can be circular or rectangular; the material of inner tube 360 and outer tube 350 may be selected from suitable materials such as PEBAX, TPU, Nylon, etc., and the size of outer tube 350 may be 8-15F; the inner tube 360 is a guide wire channel, and both the inner tube 360 and the outer tube 350 can be woven with stainless steel to provide support strength. The maximum outer diameter of the electrode arm 110 is 1mm to 2mm, the deployed working diameter D of the electrode arm may be 10mm to 20mm, such as 5mm to 35mm for a ring-shaped electrode arm; possible attachment means are gluing, hot melting, welding and the like.

Furthermore, as can be seen from the drawings of the above-described embodiments, the

electrode portions

108, 208 and 308 (i.e., the portions shown by the rectangular boxes in the drawings) are provided at the first spline segment on the electrode arm, or at the second spline segment on the electrode arm, or at the first spline segment and the second spline segment on the electrode arm. In this way, an electric field can be generated on the first side, and targeted tissue ablation can be carried out. Alternatively or additionally, the

electrode portions

108, 208 and 308 are also provided on the electrode arm at a third spline segment, or at a fourth spline segment on the electrode arm, or at both the third and fourth spline segments. In this way, an ablation electric field can be formed on the first surface and in the region other than the first surface, and flexible configuration can be performed for different scenes.

The polarity of the electrode portions 108, 208 and 308 is set to one of three configurations: the first method comprises the following steps: the electrode portions on the same electrode arm have the same polarity, for example, three electrode portions are arranged on one electrode arm, and the polarities of the three electrode portions are all positive or negative; and the second method comprises the following steps: the polarities of the electrode parts on the adjacent spline segments of the same electrode arm are different, for example, the electrode part on the first spline segment on one electrode arm is a positive electrode, the electrode part on the second spline segment on the electrode arm is a negative electrode, and the electrode part on the third spline segment on the electrode arm is a negative electrode; and the third is that: the electrode portions on the same spline segment on the two adjacent electrode arms are different in polarity, for example, the electrode portion on the first spline segment on the first electrode arm is a positive electrode, the electrode portion on the first spline segment on the second electrode arm is a positive electrode, the electrode portion on the second spline segment on the first electrode arm is a negative electrode, the electrode portion on the second spline segment on the second electrode arm is a positive electrode, and similarly, the electrode portion on the third spline segment on the first electrode arm is a negative electrode, and the electrode portion on the third spline segment on the second electrode arm is a negative electrode. The polarity of the electrode portion is merely illustrated, and the present disclosure is not limited thereto, and in practical applications, the polarity of the electrode portion may be set as needed. In this way, flexible configuration can be carried out according to specific ablation targets, and dynamic configuration of the electric field range and the electric field direction is realized, so that the ablation effect is improved. Therefore, electric fields in different directions can be formed, and the polarity of the electrode part is dynamically configured in real time according to different shapes of target tissues and the ablation target to be achieved, so that the expected ablation effect is achieved.

Fig. 4 shows a schematic internal view of the bending apparatus 370 according to an embodiment of the present disclosure, fig. 5 shows a schematic view of two discs in the bending apparatus 370 according to the embodiment shown in fig. 4 of the present disclosure, and fig. 6 shows a schematic view of the bending knob 373 in the bending apparatus 370 according to the embodiment shown in fig. 4 of the present disclosure. As can be seen from fig. 4, the bending device 370 adjusts the deflection direction of the facial ablation electrode catheter 300 by controlling the pulling wires 372 in the outer tube 350, and the two pulling wires 372 are connected to the front end of the facial ablation electrode catheter 300 via the connecting piece 371. In terms of specific structure, as can be seen from fig. 6, the bending adjustment device 370 includes a bending adjustment knob 373, and the bending adjustment knob 373 includes: first and

second housing portions

3734 and 3735, first and

second wheels

3732 and 3733, wherein first housing portion 3734 and first wheel 3732 are fixedly attached via, for example, gear portion 3736 and second housing portion 3735 and second wheel 3733 are fixedly attached via, for example, gear portion 3737, and wherein first wheel 3732 has a first securing portion 3731 and secures a proximal end of a first cable to first wheel 3732 at first securing portion 3731, and second wheel 3733 has a second securing portion 3731 and secures a proximal end of a second cable to second wheel 3733 at second securing portion 3731. In this way, the deflection direction of the surface ablation electrode catheter 300 connected thereto, for example, whether it is deflected upwards or downwards, can be controlled by means of the bending device 373. A locking mechanism, such as a geared connection, is provided between the first housing portion 3734 and the second housing portion 3735 or between the first wheel 3732 and the second wheel 3733. The locking mechanism is configured to lock the first housing portion 3734 and the second housing portion 3735 to each other or to lock the first wheel 3732 and the second wheel 3733 to each other, wherein the locking mechanism includes: a slide disposed on one of the first housing portion 3734 and the second housing portion 3735; and a slider disposed on the other of the first housing portion 3734 and the second housing portion 3735. With the first housing portion 3734 and the second housing portion 3735 locked to one another, the first disk 3732 and the second disk 3733 are also locked to one another, such that the first disk 3732 and the second disk 3733 can be actuated together to control the direction of deflection, e.g., upward deflection or downward deflection, of the face ablation electrode catheter 300 coupled thereto. In addition, the first sheave 3732 and the second sheave 3733 may have, for example, rubber rings, so that a connection damping coefficient between the wire and the first sheave 3732 and the second sheave 3733 is increased, and the adjustment accuracy is improved.

Fig. 7 is a schematic view of a face ablation electrode catheter 400 in accordance with the present disclosure. As can be seen in fig. 7, the face ablation electrode catheter 400 includes at least an outer tube 450, an electrode arm 410, and a rear end control 470.

In summary, in the area ablation electrode catheter proposed according to the present disclosure, unlike the electrode catheter in the prior art, the electrode catheter extends outward from the center and then extends a section toward the center in the opposite direction, the front end portion of the electrode arm has a portion similar to a J shape or even a U shape in the extended state to form an ablation surface, which significantly increases the range of the ablation surface, so that the area ablation electrode catheter disclosed according to the present disclosure can generate an electric field in a wider range, has a wider ablation range, and can not only satisfy small-range and fine ablation (such as pulmonary veins, atrial flutter, atrial septa, etc.), but also be applied to large-range ablation (such as atrial wall, hypertrophic myocardium, etc.), and has a wide application range.

While various exemplary embodiments of the disclosure have been described, it will be apparent to those skilled in the art that various changes and modifications can be made which will achieve one or more of the advantages of the disclosure without departing from the spirit and scope of the disclosure. Other components performing the same function may be suitably replaced by those skilled in the art. It should be understood that features explained herein with reference to a particular figure may be combined with features of other figures, even in those cases where this is not explicitly mentioned. Further, the methods of the present disclosure may be implemented in either all software implementations using appropriate processor instructions or hybrid implementations using a combination of hardware logic and software logic to achieve the same result. Such modifications to the solution according to the disclosure are intended to be covered by the appended claims.

Claims

1. A surface ablation electrode catheter, characterized in that the surface ablation electrode catheter comprises:

an outer tube configured to form a receiving cavity; and

wherein when at least a portion of each electrode arm is disposed within the receiving cavity, the at least a portion assumes a contracted state; and when at least a portion of each of the electrode arms is disposed outside of the receiving cavity, the at least a portion assumes an extended state, and wherein, in the extended state, the first spline segment and the second spline segment are in a first plane and the third spline segment and the fourth spline segment are not in the first plane, wherein the first spline segment includes a portion of the electrode arm extending from a tip of the electrode arm to a first point in the first plane at a furthest distance from the tip, the second spline segment includes a portion extending from the first point to a second point away from the first plane,

wherein the ends of the at least three electrode arms are mechanically connected by a woven mesh.

2. The surface ablation electrode catheter of claim 1, wherein the fourth spline segments extend outward from an axial center of the surface ablation electrode catheter to determine a degree of convergence of the first surface, and wherein the third spline segments are configured to connect the fourth spline segments and the second spline segments.

3. The facial ablation electrode catheter as recited in claim 1, further comprising:

an electrode arm drive configured to drive the electrode arm to move between an inner and outer position of the receiving cavity.

4. The facial ablation electrode catheter as claimed in claim 1, wherein the woven mesh has a regular polygonal shape and is made of an elastic material.

5. The area ablation electrode catheter of claim 1 or 4, further comprising:

an inner tube located within the receiving cavity; and

a center electrode disposed on the mesh and powered via a wire in the inner tube.

6. The facial ablation electrode catheter of claim 1, wherein the electrode arm further comprises:

an inner core;

a wire routed along an axial direction of the inner core; and

an insulating sleeve covering the inner core and the wire,

wherein the electrode portion is arranged outside the insulating sleeve, and wherein the lead is connected to the electrode portion at the electrode portion through the insulating sleeve.

7. The face ablation electrode catheter of claim 6, wherein the inner core is made of a memory material or a medical stainless steel material.

8. The facial ablation electrode catheter of claim 1, wherein the electrode portion is disposed on the electrode arm at the first spline segment and/or the second spline segment.

9. The facial ablation electrode catheter of claim 8, wherein the electrode section is further disposed at the third spline segment and/or the fourth spline segment on the electrode arm.

10. The facial ablation electrode catheter according to claim 1, wherein the polarity of the electrode portion is set to one of the following configurations:

the electrode parts on the same electrode arm have the same polarity;

the polarities of the electrode parts on the adjacent spline sections of the same electrode arm are different; and

the polarity of the electrode parts on the same spline segment on the two adjacent electrode arms is different.

11. The facial ablation electrode catheter as claimed in claim 1, wherein the number of the electrode arms is eight and each electrode arm has the same shape in the extended state.

12. The facial ablation electrode catheter as recited in claim 1, further comprising:

a bending adjusting device which adjusts the deflection direction of the surface ablation electrode catheter by controlling a pull wire in the outer tube,

wherein, the accent curved device includes:

a first housing part and a second housing part,

a first wheel disc and a second wheel disc, wherein the first housing portion is fixedly connected with the first wheel disc and the second housing portion is fixedly connected with the second wheel disc,

and wherein the first wheel has a first securement and secures the proximal end of the first pull wire to the first wheel at the first securement, and the second wheel has a second securement and secures the proximal end of the second pull wire to the second wheel at the second securement.

13. The facial ablation electrode catheter of claim 12, wherein a locking mechanism is disposed between the first housing portion and the second housing portion or between the first wheel and the second wheel, the locking mechanism configured to lock the first housing portion and the second housing portion or the first wheel and the second wheel to each other,

wherein the locking mechanism comprises:

a slide rail provided on one of the first housing portion and the second housing portion; and

a slider provided on the other of the first housing portion and the second housing portion.

14. An ablation device, characterized in that the ablation device comprises:

a pulse signal generator configured to generate a pulse signal; and

the facial ablation electrode catheter according to any one of claims 1 to 13, an electrode portion of the facial ablation electrode catheter being electrically connected with an output end of the pulse signal generator.