CN113081239B

CN113081239B - Cage electrode catheter and ablation device comprising same

Info

Publication number: CN113081239B
Application number: CN202110349537.9A
Authority: CN
Inventors: 王海峰; 罗中宝; 张星光; 诸敏
Original assignee: Shanghai Ruidao Medical Technology Co ltd
Current assignee: Shanghai Ruidao Medical Technology Co ltd
Priority date: 2021-03-31
Filing date: 2021-03-31
Publication date: 2024-01-09
Anticipated expiration: 2041-03-31
Also published as: CN113081239A

Abstract

The present disclosure relates to an electrode catheter, comprising: a cage having a first state and a second state, the cage being saccoid in the second state; a distal rod disposed on a first end of the cage; a first electrode disposed on the distal shaft; at least two electrode portions disposed on a cage-like support of the cage; and at least three conductors corresponding to the at least two electrode portions and the first electrode and configured to supply power to the at least two electrode portions and the first electrode.

Description

Cage electrode catheter and ablation device comprising same

Technical Field

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

Background

Atrial Fibrillation (AF) is a common arrhythmia affecting over 3300 thousands of people worldwide. Radio frequency ablation and cryoablation are currently two common methods used clinically to treat cardiac arrhythmias such as atrial fibrillation. The lesions of both ablations must be sufficient to destroy arrhythmic tissue or substantially interfere with or isolate abnormal electrical conduction within myocardial tissue, while excessive ablation affects surrounding healthy tissue as well as neural tissue, but insufficient ablation does not act to block abnormal electrical conduction. Therefore, it is important to create 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 generated in the operation of a patient due to long time, and the problems of pulmonary vein stenosis and the like easily occur after the operation. In addition, radiofrequency ablation may damage the heart endothelial surface, activate an exogenous coagulation cascade and cause coke and thrombosis, which in turn may lead to systemic thromboembolism. It follows that the application of radio frequency energy to target tissue may have an effect on non-target tissue, for example, the application of radio frequency energy to atrial wall tissue may result in damage to the digestive or nervous system, such as the esophagus. In addition, rf ablation can also lead to tissue scarring, further leading to embolic problems. While cryoablation causes a higher probability of phrenic nerve injury, epicardial freezing near the coronary arteries may also lead to thrombosis and progressive coronary stenosis.

Disclosure of Invention

In view of the deep understanding of the problems existing in the background art, that is, the existing rf ablation is time-consuming and has a tissue destructive property, and cryoablation also brings about problems such as embolism, the inventor of the present disclosure proposes an electrode catheter using a pulsed electric field ablation technique, in which an electrode is disposed on a cage-like support of a cage included in the electrode catheter, and another electrode is disposed on a distal rod connected to the cage, and the electrode cooperates with the electrode on the cage-like support of the cage to generate an effective pulsed electric field, so that the pulsed electric field can selectively ablate a target tissue to form a continuous effective ablation zone, thereby successfully blocking the adverse effect of a noise signal on the heart rate, further avoiding atrial fibrillation, and at the same time reducing or even avoiding damage to good tissue cells that do not need ablation.

Specifically, a first aspect of the present disclosure proposes an electrode catheter comprising:

a cage having a first state and a second state, the cage being saccoid in the second state;

a distal rod disposed on a first end of the cage;

a first electrode disposed on the distal shaft;

at least two electrode portions disposed on a cage-like support of the cage; and

at least three conductors corresponding to the at least two electrode portions and the first electrode and configured to power the at least two electrode portions and the first electrode.

The present disclosure innovatively proposes to use not only electrodes arranged on the cage-like support of the cage, but also a first electrode arranged outside the cage, for example on a distal rod arranged on a first end of said cage, to form an electric field, so as to be able to ensure that the generated ablation zone is for example an ablation ring that is continuous both in the radial and in the circumferential direction of the vessel, ensuring that the transmission path of the noise signal conduction to the heart and thus causing arrhythmia can be successfully cut off.

In one embodiment according to the present disclosure, the electrode catheter further comprises an outer tube connected to the cage via a second end remote from the first end and configured to control the transition of the cage between the first state and the second state. In this way it is possible to facilitate the control of the state of the cage by the operator of the electrode catheter.

In one embodiment according to the present disclosure, the at least two electrode portions are disposed on a half side of the cage proximate the first end and equidistant from the first electrode. In this way, the formation of unwanted ablation zones can be reduced or even avoided, while ensuring the formation of a closed ablating loop, so that damage to tissue that does not need to be ablated is minimized. In one embodiment according to the present disclosure, the electrode portion provided on each cage has a plurality of electrode sub-portions, so that the width of the ablation zone can be controlled.

Optionally, in one embodiment according to the present disclosure, the cage is in a ball-like capsule or a cone-like capsule in the second state. Preferably, in one embodiment according to the present disclosure, the at least two electrode portions are uniformly disposed on the cage-like support of the cage and at least a portion of the at least two electrode portions are exposed. Alternatively or additionally, in one embodiment according to the present disclosure, the cage-like support of the cage is configured to accommodate at least one conductor of the at least three conductors.

Preferably, in one embodiment according to the present disclosure, the cage brackets are uniformly disposed. Further preferably, in one embodiment according to the present disclosure, the cage-like scaffold comprises a central scaffold made of a deformable material.

In one embodiment according to the present disclosure, a potential difference exists between the first electrode and each of the at least two electrode portions. In such a way that an electric field is formed between the first electrode and the electrode portion arranged on the cage-like support, thereby forming a closed ablating loop. Preferably, in one embodiment according to the present disclosure, the first electrode is configured as a ring electrode.

In one embodiment according to the present disclosure, the potential of the first electrode and the electrode portion is configured as one of the following configurations:

the polarity of the first electrode is a pulse with positive and negative alternation and the electrode part is grounded;

the polarity of the first electrode is positive pulse or negative pulse and the electrode part is grounded;

the first electrode is grounded and the polarity of the electrode part is a pulse with positive and negative alternation;

The first electrode is grounded and the polarity of the electrode portion is either positive or negative;

the polarity of the first electrode is a positive pulse and the polarity of the electrode portion is a negative pulse; or alternatively

The polarity of the first electrode is a negative pulse and the polarity of the electrode portion is a positive pulse.

In one embodiment according to the present disclosure, the number of the at least two electrode portions is 6 to 10, preferably 8.

In one embodiment according to the present disclosure, each of the electrode portions includes a plurality of electrodes disposed at intervals along an axial direction of the cage.

In one embodiment according to the present disclosure, the electrode catheter further comprises a handle having an electrode power interface coupled to the conductor and a fluid input/output port coupled to the cage.

In one embodiment according to the present disclosure, the first electrode is configured to be movably disposed on the distal shaft between a first position and a second position of the distal shaft.

In one embodiment according to the present disclosure, the electrode catheter further comprises a first electrode position control device configured to adjust the position of the first electrode on the distal shaft.

In one embodiment according to the present disclosure, the electrode catheter further comprises an electrode cap disposed at the free end of the distal shaft, the electrode cap having a polarity different from the polarity of the first electrode.

Furthermore, a second aspect of the present disclosure proposes an ablation device comprising:

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

an electrode catheter according to the first aspect of the present disclosure, the electrode catheter being electrically connected to the pulse signal generator.

In summary, the present disclosure innovatively proposes to use not only electrodes arranged on a cage-like support of the cage, but also a first electrode arranged outside the cage, for example on a distal rod arranged on a first end of the cage, to form an electric field, so as to be able to ensure that the generated ablation zone is, for example, an ablation ring that is continuous both in the radial and circumferential direction of the vessel, ensuring that the transmission path of the noise signal to the heart leading to arrhythmia can be successfully cut off.

Drawings

The embodiments are shown and described with reference to the drawings. The drawings serve to illustrate the basic principles and thus only show aspects necessary for understanding the basic principles. The figures are not to scale. In the drawings, like reference numerals refer to like features.

FIG. 1 shows a schematic view of an electrode catheter 100 according to one embodiment of the present disclosure;

FIG. 2 shows a schematic diagram of an electrode catheter 200 according to another embodiment of the present disclosure;

fig. 3 illustrates an exploded view of an electrode catheter 300 according to yet another embodiment of the present disclosure;

fig. 4 shows an exploded view of an electrode catheter 400 according to yet another embodiment of the present disclosure;

fig. 5 shows a cross-sectional view of an electrode catheter 500 according to yet another embodiment of the present disclosure;

fig. 6 shows an enlarged view of a first end of the electrode catheter 500 of fig. 5;

fig. 7 shows an enlarged view of a second end of the electrode catheter 500 of fig. 5 opposite the first end;

fig. 8 shows a perspective view of a first electrode of the electrode catheter 500 of fig. 5;

fig. 9 shows a perspective view of the distal shaft of the electrode catheter 500 of fig. 5;

FIG. 10 shows a schematic view of an inner tube 570 of the electrode catheter 500 of FIG. 5;

fig. 11 shows a schematic diagram of an ablation device 1000 in accordance with an embodiment of the present disclosure;

FIG. 12a shows a schematic view of the position of an electrode catheter 900 with a target tissue at the time of ablation by means of the disclosed electrode catheter according to the present disclosure; and

fig. 12b shows a schematic view of the ablation zone formed at the end of the ablation shown in fig. 12 a.

Other features, characteristics, advantages and benefits of the present disclosure will become more apparent from the following detailed description taken 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 may be practiced. The illustrated embodiments are not intended to be exhaustive of all embodiments according to the present disclosure. It is to be understood that other embodiments may be utilized and structural or logical modifications 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 for treatment of atrial fibrillation is a pulsed electric field technique that applies a brief high voltage to the target tissue cells that can generate a local high voltage electric field of several hundred volts per centimeter. The local high voltage electric field disrupts the cell membrane by forming perforations in the cell membrane where the applied electric field is above the cell threshold so that the perforations do not reclose, thereby rendering such electroporation irreversible. The perforation will cause 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 threshold values without affecting other non-target cellular tissues such as nerve cells, esophageal cells, vascular cells, and blood cells. Meanwhile, the energy is released for a very short time, so that the pulse electric field technology does not generate obvious thermal effect, and the problems of tissue injury, pulmonary vein stenosis and the like are avoided.

In particular, pulsed electric field technology (PET) ablates into non-thermal damage technology, the mechanism of which is the nano-scale micro-pores of certain cell membranes by high frequency electrical pulses. Potential advantages of PET ablation techniques that can be used for atrial fibrillation ablation include the following: firstly, the PET ablation technology can pertinently select or avoid target tissues by setting different thresholds, so that surrounding tissues can be protected from damage; secondly, the PET ablation technology can be rapidly released within a few seconds, namely, the treatment time of cells of the target tissue is short, and the PET ablation technology is easy to accept by a user; furthermore, compared to cryoablation, PET ablation techniques do not exhibit coagulative necrosis, thus reducing the risk of stenosis of the Pulmonary Veins (PV).

In order to apply the pulsed electric field technique PET described above to perform ablation, the present disclosure uses a cage to fix and shape the electrode, so design is because the cage has a smaller volume in a first state (e.g., a state similar to a tube that is contracted as a whole) and is easy to extend into a target position, and is switched to a second state (e.g., a state similar to a capsule that is enlarged as a whole) after reaching the target position, at this time, the cage is easy to abut, e.g., a pulmonary vein orifice of one of application scenes is generally elliptical, while other target positions may have other shapes, although the shapes of the target positions are different, the shape of the pulmonary vein orifice can be changed when the cage presents a state similar to a capsule, the pulmonary vein orifice with different fitting shapes can be changed, and a better fitting effect will ensure a better subsequent PET ablation effect. In addition, after the cage presents the second state, the contrast is obvious under the X-ray, so that a doctor can observe the fitting condition with the target tissue easily, and the fitting effect can be further ensured; furthermore, after the cage is occluded with a target tissue such as the ostium of a pulmonary vein, contrast media may be injected through the lumen to observe and adjust the occlusion of the cage.

In addition to applying a cage that is switchable between a first state and a second state, the present disclosure innovatively proposes to use not only electrodes arranged on the cage-like support of the cage, but also electrodes arranged outside the cage, for example on a distal rod arranged on a first end of the cage, to form an electric field, so as to be able to ensure that the generated ablation zone is an ablation ring that is continuous both in radial and circumferential directions of the pulmonary vein, ensuring that the transmission path of arrhythmias due to the conduction of abnormal signals triggered or driven by an ectopic excitation burner can be successfully cut off. Preferably, the electrode arranged on the distal shaft is movable in the axial direction of the pulmonary vein, so that it can be determined whether the extent of the ablation zone is to be adjusted according to the ablation effect. It is further preferred that an electrode cap having a polarity different from that of the first electrode can be provided at the free end of the distal rod away from the cage, so that the range of the ablation region can be further adjusted to ensure excellent ablation effect.

In particular, the structure of the electrode catheter according to the present disclosure and the structure of the corresponding ablation device will be described below with reference to fig. 1 to 11.

Fig. 1 shows a schematic diagram of an electrode catheter 100 according to one embodiment of the present disclosure. As can be seen in fig. 1, the electrode catheter 100 disclosed in accordance with the present disclosure includes a basket 110, a distal shaft 120, a first electrode 130, a plurality of electrode portions 141, 142, 143, 144, 145, a plurality of conductors (not shown in fig. 1), and an outer tube 160. Wherein the cage 110 has a first state and a second state, only the second state of which is shown in fig. 1, the cage 110 has similar shapes and thicknesses of the distal rod 120 and the outer tube 160 in the first state and on both the left and right sides. The cage 110 assumes a bladder-like shape in the second state shown in fig. 1. Furthermore, a distal rod 120 is provided on a first end of the cage 110, in the view shown in fig. 1 on the left hand side of the cage 110, and a first electrode 130 can be provided on the distal rod 120 for subsequent ablation to form an electric field. Furthermore, as can be seen from fig. 1, the five electrode parts 141, 142, 143, 144, 145 are shown arranged on the cage-like support of the cage 110. Here, it should be understood by those skilled in the art that five electrode portions are shown here, and that the number of electrode portions is not limited so long as there are more than two electrode portions so as to be able to form a desirable electric field with the first electrode 130 disposed on the distal rod 120 for ablation. In one embodiment according to the present disclosure, as shown by electrode portions 141 in fig. 1, each electrode portion includes a plurality of electrodes disposed at intervals along the axial direction of the cage.

In addition to the components described above, the electrode catheter disclosed in accordance with the present disclosure also includes, for example, a plurality of conductors, including, for example, six conductors in fig. 1. Here, it should be understood by those skilled in the art that the inner tube is here, for example, six wires, and the wires are only more than two or three, so that they can be used for a corresponding number of electrode parts and first electrodes, and so that there can be a potential difference with the first electrode 130 and a plurality of electrode parts provided on the distal rod 120, so that a more ideal electric field can be formed for ablation, i.e. the number of wires is not limited too, but in principle, for example, six wires correspond to the five electrode parts 141, 142, 143, 144, 145 and the first electrode 130 and are configured to supply the five electrode parts 141, 142, 143, 144, 145 and the first electrode 130. Furthermore, the conductors supplying the first electrode 130 may be located, for example, in the inner tube 170 inside the cage 110.

Furthermore, it can be seen that, preferably, in the embodiment shown in fig. 1, the electrode catheter 100 according to the present disclosure can also, for example, comprise an outer tube 160, which outer tube 160 is connected to the cage 110 via a second end (for example, the end of the right-hand portion of the cage 110 in the direction shown in fig. 1) remote from the first end (for example, the end of the left-hand portion of the cage 110 in the direction shown in fig. 1) and is configured for controlling the transition of the cage 110 between the first state and the second state. Before the cage 110 has reached the target site, the cage 110 assumes, for example, a first state in which the thickness of the cage 110 is similar to that of the left and right distal rods 120 and the outer tube 160, thereby facilitating delivery of the electrode catheter 100 with the cage 110 to the target site, for example, via a venous blood vessel. After reaching the vicinity of the target position, the cage 110 can be switched from the first state to the second state, for example, through the outer tube 160, and the cage is in an expanded bag shape at this time so as to fit the tissue to be ablated, and after the volume becomes large, the position of the cage 110 can be finely adjusted, for example, through the outer tube 160, so that the cage can be better fit the tissue to be ablated, and the treatment effect can be improved. It will be appreciated by those skilled in the art that the above-described positioning process can also be assisted, for example by means of an X-ray machine or by means of contrast techniques, in order to be positioned precisely, which provides for a good subsequent ablation effect.

Further, after ablation is completed, for example, the ablation effect can be evaluated first, and then a decision can be made as to whether a predetermined ablation effect is achieved to further decide whether supplemental ablation is needed or the electrode catheter 100 can be withdrawn. After a predetermined ablation effect is achieved, the cage 110 can be switched back from the second state to the first state, for example via the outer tube 160, before the electrode catheter 100 is withdrawn, so that the electrode catheter 110 can be withdrawn without or with little damage to the vein through which it is passed.

As previously described, the present disclosure innovatively proposes to form an electric field not only using electrode portions arranged on the cage-like support of the cage 110, but also using first electrodes 130 arranged outside the cage 110, for example on the distal rod 120 arranged on the first end of said cage 110, so as to be able to ensure that the ablation zone generated is a continuous ablation ring both radially and circumferentially of the blood vessel, ensuring that the transmission path of the abnormal signal triggered or driven by the ectopic foci can be successfully cut off, thus causing arrhythmia. In order to achieve a more excellent ablation effect, it is preferred that the first electrode arranged on the distal shaft is movable in the axial direction of the blood vessel, so that the extent of the ablation zone can be adjusted according to the ablation need.

Fig. 2 shows a schematic diagram of an electrode catheter 200 according to another embodiment of the present disclosure. As can be seen in fig. 2, the electrode catheter 200 disclosed in accordance with the present disclosure includes a cage 210, a distal shaft 220, a first electrode 230, a plurality of electrode portions 241, 242, 243, and an outer tube 260, and the electrode catheter 200 should further include a plurality of conductors, such as wires, which can be disposed, for example, within the cage of the cage 210 or within the inner tube 270. Wherein the cage 210 has a first state and a second state, only the second state of which is shown in fig. 2, the cage 210 has similar shapes and thicknesses of the distal rods 220 and the outer tube 260 on the left and right sides in the first state. The cage 210 assumes a bladder-like shape in the second state shown in fig. 2. Furthermore, a distal rod 220 is provided on a first end of the cage 210, on the left-hand end of the cage 210 as shown in fig. 2, and a first electrode 230 can be provided on the distal rod 220 for subsequent ablation to form an electric field. Furthermore, as can be seen from fig. 2, three electrode portions 241, 242, 243 are shown arranged on the cage support of the cage 210. Here, it should be understood by those skilled in the art that three electrode portions are shown here, and electrode portions are also provided on the back surface that is not visible, and that more than two electrode portions are required to form a preferable electric field with the first electrode 230 provided on the distal rod 220 for ablation, i.e., the number of electrode portions is not limited. In one embodiment according to the present disclosure, as shown by electrode portions 241 in fig. 2, each electrode portion includes a plurality of electrodes disposed at intervals along the axial direction of the cage.

In addition to the above-described components, the electrode catheter 200 disclosed in accordance with the present disclosure includes, for example, a plurality of conductors, it will be appreciated by those skilled in the art that the number of wires depends on the number of electrode portions and the arrangement of the first electrode, and that the number of wires corresponds to a corresponding number of electrode portions and the first electrode, such that there is a potential difference between the first electrode 230 and the plurality of electrode portions arranged on the distal shaft 220 to create a more desirable electric field for ablation, i.e., the number of wires is not limited too much, but in principle, for example, the at least two conductors and the conductors of the first electrode 230 correspond to the at least two electrode portions 241, 242, 243 and the first electrode 230 and are configured to supply power to the at least two electrode portions 241, 242, 243 and the first electrode 230. Also as previously described, the conductors for powering the first electrode 230 may be located, for example, within an inner tube 270 inside the cage 210, not shown in fig. 2.

It will be appreciated by those skilled in the art that the above-described control of the state of the cage 110 or 210 using the outer tube 160 or 260 is merely an example, and that the cage 110 or 210 itself can have a state control component that causes the cage 110 or 210 to be in either the first state or the second state by receiving a control signal, for example, without passing through the outer tube 160 or 260.

Furthermore, as can be seen from fig. 2, the first electrode 230 is configured to be movable on the distal rod 220, for example, in the axial direction, between a first position (for example, a position shown by a left-hand broken line in fig. 2) and a second position (for example, a position shown by a right-hand broken line in fig. 2) of the distal rod 220, i.e., the first electrode 230 is movable within a range of travel, indicated by a symbol T in fig. 2, formed by the distal rod 220. If a wider travel ablation zone is desired, the first electrode 230 may be positioned farther from the electrode portions 241, 242, and 243 than indicated by the left dashed lines; conversely, if a narrower travel ablation zone is desired, the first electrode 230 may be positioned closer to the electrode portions 241, 242, and 243 as identified by the right dashed lines. Furthermore, as can be seen in fig. 2, there is a slit 272 in the distal shaft 220, through which slit 272 a traction guidewire present inside the inner tube 270 can power the first electrode 230 and control the specific position of the first electrode 230 to move over the stroke T.

In order to achieve a precise control of the position of the first electrode, the electrode catheter further comprises a first electrode position control device configured for adjusting the position of the first electrode on the distal shaft. Fig. 3 illustrates an exploded view of an electrode catheter 300 according to yet another embodiment of the present disclosure. As can be seen in fig. 3, the disclosed electrode catheter 300 according to the present disclosure includes a cage formed from each cage-like support, which in turn includes a central support 312, for example, made of a deformable material, such that the cage assumes a first state when the central support 312 is in a straight state, and a second state when the central support 312 is in a raised state. The cage furthermore comprises, for example, an insulating layer 311 which is sleeved outside the central support 312, while, for example, electrode portions 341 are provided uniformly outside the insulating layer 311, which electrode portions 341 can be either ring-shaped electrodes which facilitate the installation in this case or else electrodes of other forms, for example patch electrodes. While the conductors 350 for supplying power to the electrode portions 341 are provided, for example, inside the insulating layer 311, in order to supply power to the electrode portions 341 outside the insulating layer 311, the insulating layer 311 has openings at the mounting positions of the electrode portions 341, so that the conductors 350 are electrically connected to the electrode portions 341 via the respective openings.

In addition, the electrode catheter 300 further includes a distal shaft 320, a first electrode 330, a plurality of electrode portions 341, a plurality of conductors 350, and an outer tube 360 and an inner tube 370. Wherein the cage 310 has a first state and a second state, only the second state of which is shown in fig. 3, the cage 310 has similar shapes and thicknesses of the distal rods 320 and the outer tube 360 on the left and right sides in the first state. The cage 310 assumes a bladder-like shape in the second state shown in fig. 3. In addition, a distal shaft 320 is disposed on a first end of the cage 310, on the left-hand side of the cage 310 as viewed in FIG. 3, and a first electrode 330 can be disposed on the distal shaft 320 for subsequent ablation to form an electric field.

Furthermore, as can be seen from fig. 3, the electrode portion 341 is shown arranged on a cage support of the cage 310. In addition to the components described above, the electrode catheter 300 disclosed in accordance with the present disclosure includes, for example, a plurality of conductors, five conductors being shown in fig. 3, where one skilled in the art will appreciate that the number of wires depends on the number of electrode portions and the arrangement of the first electrodes, and that the number of wires corresponds to a corresponding number of electrode portions and first electrodes, so that there is a potential difference between the first electrode and the plurality of electrode portions disposed on the distal shaft to form a more desirable electric field for ablation.

In addition to the above-mentioned components, it can also be seen from fig. 3 that the electrode catheter 300 further comprises a first electrode position control means 371, said first electrode position control means 371 being configured for adjusting the position of said first electrode 330 on said distal shaft 320, e.g. in case of a first electrode 330 self-contained drive means, the first electrode position control means 371 being capable of e.g. issuing a control signal to the first electrode 330 self-contained drive means, which first electrode 330 self-contained drive means then effecting an adjustment of the desired position in dependence of the control signal.

Of course, the above-mentioned position adjustment can also be achieved, for example, by means of a mechanical driving of the first electrode position control device 371, for example, the first electrode position control device 371 can be moved in axial direction with respect to the outer tube 360 or the inner tube 370, thereby driving the first electrode 330 to move on the distal rod 320, thereby adjusting the position of the first electrode 330 on the distal rod 320. In one embodiment, the control device 371 includes a traction wire that acts as both a conductor for supplying power to the first electrode 330 and as a control device for effecting the above-described positional adjustment in a mechanically driven manner. The distal shaft 320 is axially provided with at least one slit through which the pull wire is connected to the first electrode 330.

The above description of fig. 1 to 3 describes the structure of the front end of the ablation device for the ablation portion, and in these three embodiments, the electrode portions are disposed on the half sides of the cages 110, 210 and 310 near the first end, i.e., the left side areas of the cages 110, 210 and 310, and the electrode portions are disposed at substantially equal distances from the first electrodes 130, 230 and 330. By the arrangement, the ablation effect can be ensured to meet the expected effect, the size of the ablation zone can be minimized as small as possible, and the tissue which is not necessary to be ablated is prevented from being ablated. This is because if the electrode portions are disposed at unequal distances from the first electrodes 130, 230, and 330, the electrode portions farther away form an additional ablation region, which is however of little practical effect, i.e., ablation of that region is unnecessary.

In addition, the cages 110, 210, and 310 are in a ball-like or balloon-like shape in the second state. The balloon-like ablation results are better when using high voltage pulses, because the spacing between the electrodes is wider, allowing a wider ablation zone to be formed; in contrast, when low voltage pulses are used, balloon-like ablation results are better because the electrodes are more closely spaced and the ablation zone is not discontinuous by voltage drops. However, the cages 110, 210, and 310 of the present embodiment, whether in a balloon-like or balloon-like shape, do not have ablation dead zones in the ablating loop.

Further, as can be seen from among the electrode catheters 100, 200 and 300 shown in fig. 1 to 3, the cage-like supports are uniformly arranged, and the at least two electrode parts are uniformly arranged on the cage-like supports of the cages 110, 210 and 310 and at least a part of the at least two electrode parts are exposed, for example, at least a part of the at least two electrode parts at a side remote from the cages 110, 210 and 310 are exposed. In such a way that the exposed electrode portion is able to conform to the area to be ablated, thereby forming a suitable ablating loop in cooperation with the electrode provided on the distal shaft. When a specific ablation is performed, there is a potential difference between the first electrode 130 and each of the at least two electrode portions 141, 142, 143, 144 and 145 in fig. 1. Accordingly, there is a potential difference between the first electrode 230 and each of the at least two electrode parts 241, 242 and 243 in fig. 2, and a potential difference between the first electrode 330 and each of the at least two electrode parts 341 in fig. 3. Thereby forming an electric field between the first electrode and the electrode part so that the subsequent ablation process can be smoothly performed.

Preferably, for example in the example of electrode catheter 200 shown in fig. 2, the cage-like support of the cage 210 is configured to accommodate at least one of the at least three conductors, such as a conductor, e.g., a wire, for powering the electrode portions 241, 242, and/or 243. Since the wires are received in the cage brackets of the cage 210, such wires are not readily visible from fig. 2, whereas conductors such as wires 350 are readily visible in the exploded view shown in fig. 3. It will be appreciated by those skilled in the art that due to the presence of such a cage-like support of the cage 210, the conductors are well received therein, so that the surface of the cage-like support of the cage 210 may be flat, although by the presence of conductors, to facilitate implantation of the electrode catheter 200. As previously described, at least a portion of the electrode portions 241, 242, and 243 are bare for use in an ablation process. While other conductive portions require an insulating treatment to be able to control the ablated area, rather than uncontrolled. To this end, in the example shown in fig. 3, at least one conductor (e.g., conductor 350) of the at least three conductors (e.g., conductor 350) is provided with an insulator on a side remote from the cage 210. Preferably, the entire outer surface of the conductor 350 can also be coated or encased with an insulator, such as the insulating layer 311.

As shown in fig. 1 and 2, the electrode parts 141, 142, 143, 144, 145, 241, 242, 243 are substantially in the shape of electrode rings, the long axes of the electrode parts 141, 142, 143, 144, 145, 241, 242, 243 are disposed along the axial direction of the electrode catheter 100, 200 and the electrode part length L is related to a preset shortest ablation width W in the vein axis direction and an ablation voltage V applied between the first electrode 130, 230 and the electrode parts 141, 142, 143, 144, 145, 241, 242, 243. For example, the long axis of the electrode portions 141, 142, 143, 144, 145, 241, 242, 243 is arranged along the axial direction of the electrode catheter 100, 200 including the cages 110, 210, and the length L of the electrode portions 141, 142, 143, 144, 145, 241, 242, 243 is determined based on a preset ablation width W in the pulmonary vein axial direction and an ablation voltage V applied to the electrode portions 141, 142, 143, 144, 145, 241, 242, 243. The relation between the ablation width W and the ablation voltage V, for example, exhibits the following relation in the case of different electrode section lengths L, for example, when L is 3mm, 4mm, 5mm, 6mm or 7 mm: the ablation width W is approximately linear with the ablation voltage V, and thus can be fitted using the following fitting function:

W=a1 (L) v+a2 (L), where a1 (L) and α2 (L) represent functions on L.

Preferably, for example in the electrode catheter 200 shown in fig. 2, the first electrode 230 is configured as a ring electrode. In the examples shown in fig. 1 to 3, the potentials of the first electrodes 130, 230, 330 and the electrode portions 141, 142, 143, 144, 145, 241, 242, 243, 341 are configured to be one of the following configurations: the first configuration is that the polarity of the first electrodes 130, 230, 330 is a pulse of alternating positive and negative and the electrode portions 141, 142, 143, 144, 145, 241, 242, 243, 341 are grounded; the second configuration is that the polarity of the first electrode 130, 230, 330 is positive or negative and the electrode portion 141, 142, 143, 144, 145, 241, 242, 243, 341 is grounded; a third configuration is a pulse in which the first electrode 130, 230, 330 is grounded and the polarities of the electrode portions 141, 142, 143, 144, 145, 241, 242, 243, 341 are alternately positive and negative; the fourth configuration is that the first electrode 130, 230, 330 is grounded and the polarity of the electrode portions 141, 142, 143, 144, 145, 241, 242, 243, 341 is positive or negative; a fifth configuration is that the polarity of the first electrode 130, 230, 330 is a positive pulse and the polarity of the electrode portion 141, 142, 143, 144, 145, 241, 242, 243, 341 is a negative pulse; or for example the sixth configuration is that the polarity of the first electrode 130, 230, 330 is a negative pulse and the polarity of the electrode portion 141, 142, 143, 144, 145, 241, 242, 243, 341 is a positive pulse. The number of the at least two electrode portions 141, 142, 143, 144, 145, 241, 242, 243, 341 may be, for example, 6 to 10, and preferably 8. Here, the at least two electrode parts 141, 142, 143, 144, 145, 241, 242, 243, 341 may be flexible electrodes.

Fig. 4 shows an exploded view of an electrode catheter 400 according to yet another embodiment of the present disclosure; as can be seen in fig. 4, the electrode catheter 400 includes an electrode catheter 300 in accordance with the disclosure including a cage formed from each cage-like support, which in turn includes a center support 412, for example, made of a deformable material such that the cage assumes a first state when the center support 412 is in a straight state and assumes a second state when the center support 412 is in a raised state. Furthermore, the cage comprises, for example, an insulating layer 411 which is sleeved outside the central support 412, whereas, for example, electrode portions 441 are provided uniformly outside the insulating layer 411, one or more of the electrode portions 441 being either a ring-shaped electrode which facilitates the installation in this case or else an electrode of another form, for example a patch electrode. While the conductors 450 for supplying power to the electrode portions 441 are provided, for example, inside the insulating layer 411, in order to supply power to the electrode portions 441 outside the insulating layer 411, the insulating layer 411 has openings at the mounting positions of the electrode portions 441, so that the conductors 450 are electrically connected to the electrode portions 441 via the respective openings.

In addition, the electrode catheter 400 includes a distal shaft 420, a first electrode 430, a plurality of electrode portions 441, a plurality of conductors 450, and an outer tube 460 and an inner tube 470. Wherein the cage 410 has a first state and a second state, only the second state of which is shown in fig. 4, the cage 410 has similar shapes and thicknesses of the distal rods 420 and the outer tube 460 on the left and right sides in the first state. The cage 410 assumes a capsule-like shape in the second state shown in fig. 4. In addition, a distal rod 420 is disposed on a first end of the cage 410, on the left-hand end of the cage 410 as shown in fig. 4, and a first electrode 430 can be disposed on the distal rod 420 for subsequent ablation to create an electric field.

Furthermore, as can be seen from fig. 4, the electrode portion 441 is shown arranged on a cage-like support of the cage 410. In addition to the components described above, the electrode catheter 400 disclosed in accordance with the present disclosure includes, for example, a plurality of conductors, five conductors being shown in fig. 4, where one skilled in the art will appreciate that the number of wires depends on the number of electrode portions and the arrangement of the first electrodes, and that the number of wires corresponds to a corresponding number of electrode portions and first electrodes, so that there is a potential difference between the first electrode and the plurality of electrode portions disposed on the distal shaft to form a more desirable electric field for ablation.

In addition to the above-mentioned components, it can also be seen from fig. 4 that the electrode catheter 400 further comprises a first electrode position control device 471, said first electrode position control device 471 being configured for adjusting the position of said first electrode 430 on said distal shaft 420, e.g. in case of a first electrode 430 self-contained drive device, the first electrode position control device 471 being able to send e.g. a control signal to the first electrode 430 self-contained drive device, which then effects the adjustment of the desired position in dependence of the control signal.

Of course, the above-mentioned position adjustment can also be achieved, for example, by means of a mechanical driving of the first electrode position control device 471, for example, the first electrode position control device 471 can be moved axially with respect to the outer tube 460 or the inner tube 470, thereby driving the first electrode 430 to move on the distal rod 420, thereby adjusting the position of the first electrode 430 on the distal rod 420. In one embodiment, the control device 471 includes a traction guidewire that serves both as a conductor for supplying power to the first electrode 430 and as a control device for mechanically driving the position adjustment. The distal shaft 420 is axially provided with at least one slit through which the pull wire is connected to the first electrode 430.

In addition to the above structure, an electrode cap 425 may be added to the distal end of the distal rod 420, such as a support, and the electrode cap 425 forms an electric field with the electrode ring 430 for supplementary ablation when an ablation region formed by ablation by the electric field between the electrode portion 441 on the cage-like support of the cage 510 and the electrode ring 430 is incomplete. In one embodiment the leads of the electrode cap 425 are connected to the handle via an inner tube within the distal shaft. In the present disclosure, the electrode ring 430 may be moved back and forth in accordance with the ablation requirements, such that the ablation field region is varied, e.g., such that the ablation region extends axially inward of the ostium of the pulmonary vein. The polarity of the electrode cap 425 is different from that of the electrode ring 430, which is the first electrode, so that the range of the ablation zone can be further adjusted, and excellent ablation effect can be ensured.

In the embodiment according to the present disclosure, the cage-like support of the cage 110, 210, for example, may comprise an insulating layer 311, 411 made of an insulating material such as PEBAX, PET, nylon, TPU. While the conductors 350, 450 can be, for example, circular or rectangular in cross-section; the electrode portions 141, 142, 143, 144, 145, 241, 242, 243, 341, 441 are in the shape of an electrode ring, the electrode portions 141, 142, 143, 144, 145, 241, 242, 243, 341, 441, 541 are uniformly distributed in the same cross section, and the number of the electrodes can be 6 to 10, preferably 8; the diameter of the outer tube 160, 260, 360, 460 is 9-15 Fr, wherein French (F or Fr) is the diameter unit of a catheter commonly used in the medical instrument field, 3Fr is about 1mm, and the outer tube 160, 260, 360, 460 can be single lumen or multi-lumen; the inner tube is a mapping electrode catheter/guide wire/contrast agent injection channel. The support piece and the cage-shaped object, and the connection of the cage-shaped object and the outer tube can adopt glue or hot-melt welding technology; the support member and the inner tube, the electrode portion and the cage, and the conductor and the cage can be connected by glue, and the glue is preferably UV glue. Furthermore, the electrode catheter 100, 200, 300, 400 can preferably comprise a handle, which can be connected, for example, to the outer tube 160, 260, 360, 460, and on which an electrode supply interface connected to the conductor and a fluid input/output port connected to the cage are provided.

Fig. 5 illustrates a cross-sectional view of an electrode catheter 500 in accordance with yet another embodiment of the present disclosure. As can be seen in fig. 5, an electrode catheter 500 according to the present disclosure includes a distal shaft such as a support 520, an electrode ring (not shown), a traction wire (not shown), a cage 510, an electrode portion (not shown), a wire (not shown), a cover for the wire (not shown), an inner tube (not shown), and an outer tube (not shown). In the version shown in fig. 5, the support 520 is used for distal support of the cage 510 and can be used for pulmonary vein ostia positioning; the electrode ring is placed on the distal neck of the cage 510 and can be controlled to move axially a distance by a traction wire, which simultaneously serves as both a traction device for the electrode ring and a delivery voltage wire, thereby enabling movable placement of the electrode ring. The traction wires are connected to the electrode ring via axially disposed slits of the support 520 and extend along the lumen of the inner tube to a handle (not shown in fig. 5), the cage-like support of the cage 510 extends to the proximal end 580 of the balloon 510 and embeds the wires, securing the electrode portion, which can be, for example, a flexible electrode or an inert metal electrode, to the cage-like support of the cage 410, and the covering of the wires covers the wires, which can be, for example, a film or glue.

Fig. 6 shows an enlarged view of a first end of the electrode catheter 500 of fig. 5. As can be seen in fig. 6, an electrode ring 530 can be provided at the distal shaft 520, the electrode ring 530 being powered and pulled by a pulling wire 571, thereby effecting a change in the position of the electrode ring 530 on the distal shaft 520, thereby regulating the ablation effect. In another case, the electrode catheter 500 further comprises a first electrode position control means 571, said first electrode position control means 571 being configured for adjusting the position of said first electrode 530 on said distal shaft 520, e.g. in case of a first electrode 530 self-contained drive means, the first electrode position control means 571 being capable of e.g. issuing a control signal to the first electrode 530 self-contained drive means, which first electrode 530 self-contained drive means then effecting an adjustment of the desired position in dependence of the control signal.

Fig. 7 shows an enlarged view of the second end of the electrode catheter 500 of fig. 5, opposite the first end, i.e. of the proximal end, from which fig. 7 it can be seen that the outer tube 560 has a larger tube diameter than the inner tube 570, from which the outer tube 560 extends in a direction away from the cage 510, whereas the inner tube 570 has an extension in the axial direction of the entire electrode catheter 500, in correspondence with which the conductor 550 also has an extension in the axial direction of the entire electrode catheter 500, so that the electrode sections as well as the respective electrode rings 530 and possibly the motor cover can be supplied. In addition, proximal end 580 has a proximal fixation mount thereon to enable fixation of these structures together.

Fig. 8 shows a perspective view of a first electrode of the electrode catheter 500 of fig. 5. As can be seen from fig. 8, the ring electrode 530 includes an electrode ring pull wire holder 572 connected thereto, and the ring electrode 530 is supplied with power via the electrode ring pull wire holder 572, and is also mechanically position-controlled by the electrode ring pull wire holder 572. In another instance, the electrode catheter 500 further comprises a first electrode position control device configured to adjust the position of the ring electrode 530 on the distal shaft 520, e.g., in the case of a ring electrode 530 self-contained drive device, the first electrode position control device can send a control signal to the ring electrode 530 self-contained drive device via the electrode ring pull wire holder 572, for example, and then the ring electrode 530 self-contained drive device can effect the desired position adjustment based on the control signal.

Fig. 9 shows a perspective view of the distal shaft of the electrode catheter 500 of fig. 5. As can be seen in fig. 9, the distal rod 520 has an electrode ring detent 522 thereon, the electrode ring detent 522 defining two extreme positions of the position at which the ring electrode 530 can be moved back and forth across the distal rod, the two extreme positions defining a range of movable positions of the ring electrode 530. In addition, the distal rod 520 includes an electrode ring runner 521, and the ring electrode 530 can be powered and position controlled by conductors passing through the electrode ring runner 521. Furthermore, the distal rod 520 further comprises a fixation hole 523 for a flexible cage-like support of the cage 510, in which the flexible cage-like support constituting the cage 510 can be accommodated for fixation at the distal rod 520. Correspondingly, there are also fixation holes in the proximal end 580 for such flexible cage-like supports of the cage 510, in which the flexible cage-like supports constituting the cage 510 can be accommodated for fixation at the proximal end 580.

Correspondingly, fig. 10 shows a schematic view of the inner tube 570 of the electrode catheter 500 in fig. 5. As can be seen in the figures, the inner tube 570 has a receiving groove 573 for the traction wire of the electrode ring 530 near the operation end, and an electrode ring sliding hole 574 at a position corresponding to the installation position of the electrode ring 530, so that the electrode ring 530 can be supplied with power and the position of the electrode ring 530 on the distal rod 520 can be controlled through the electrode ring sliding hole 574 via the traction wire received in the receiving groove 573.

Fig. 11 shows a schematic diagram of an ablation device 1000 in accordance with an embodiment of the present disclosure. That is, the present disclosure also relates to an ablation device 1000 for performing irreversible electroporation, the ablation device 1000 having a pulse signal generator configured to generate a pulse signal (not shown in the drawings), the electrode catheter 600 being connected to the pulse signal generation module and transmitting the pulse signal to a target site through an electrode ring and an electrode portion of the electrode catheter 600. Furthermore, the ablation device 1000 comprises an electrode catheter 600 according to the foregoing, said electrode catheter 600 being electrically connected to said pulse signal generator. Still further, optionally, the ablation device 1000 can also include an operation control member 800, the operation control member 800 (e.g., the aforementioned handle) configured to control the pulse signal generator and manipulate the electrode catheter 600. Furthermore, as can be seen in fig. 6, the ablation device 1000 can also include, for example, four interfaces 700, such as integrated positive and negative cable interfaces, mapping electrode catheter 600/guidewire/contrast access interfaces, and gas/liquid injection interfaces, for example.

In a specific use of the ablation device 1000 shown in fig. 6, a vascular sheath is first placed into the bilateral femoral vein, for example, using femoral vein puncture. Delivering the coronary sinus electrode into place through the left sheath; performing atrial septum puncture through the right femoral vein, and performing left atrial and pulmonary vein radiography; then, replacing the pulse ablation delivery system; next, electrode catheter 600 including a cage and a mapping catheter are fed; then, mapping the catheter into the target vein of interest; the cage 600 is then switched to the second state and positioned; finally, the pulmonary vein ostia are occluded by the cage 600 and ablated.

Fig. 12a shows a schematic view of an ablation zone formed at the end of ablation by means of an electrode catheter 900 according to the disclosure and a target tissue at the time of ablation, while fig. 12b shows a schematic view of an ablation zone formed at the end of ablation shown in fig. 12a, from which it can be seen that an ablation zone 902 of concentric circular band shape, for example, surrounding a distal shaft, can be formed by means of an electrode arranged on a cage-like support of a cage of the electrode catheter 900 and a first electrode arranged on the distal shaft, the ablation zone 902 being located between the non-ablation zone 901 and the non-ablation zone 903, and from which fig. 12b it can be further seen that the ablation zone 902 of a white zone has a relatively uniform ablation width, does not form an ablation zone of varying width, and that the ablation zone is continuously closed, i.e. does not form a discontinuous zone somewhere in the middle, thereby ensuring that a transmission path of an arrhythmia due to conduction of an abnormal signal activated or driven by an ectopic excitation range can be successfully cut off.

Although various exemplary embodiments of the present 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 replaced as appropriate by those of ordinary skill in the art. It will be appreciated that features explained herein with reference to particular figures may be combined with features of other figures, even in those cases where such is not explicitly mentioned. Furthermore, the methods of the present disclosure may be implemented in either all software implementations using appropriate processor instructions or in hybrid implementations utilizing hardware logic and software logic combinations to achieve the same results. Such modifications to the solution according to the present disclosure are intended to be covered by the appended claims.

Claims

1. An electrode catheter, the electrode catheter comprising:

a distal rod disposed on the first end of the cage, the distal rod for distal fixed support of the cage and for positioning of a pulmonary vein ostium;

a first electrode disposed on the distal shaft, the first electrode configured as a ring-shaped electrode, the first electrode being axially movable a distance controlled by a traction wire that simultaneously serves as a traction device for the first electrode and a delivery voltage wire;

at least two electrode portions disposed on a cage-like support of the cage, the at least two electrode portions disposed on a half side of the cage near the first end and equidistant from the first electrode; and

at least three conductors corresponding to the at least two electrode portions and the first electrode and configured to power the at least two electrode portions and the first electrode, wherein the first electrode is configured to be movably disposed on the distal rod between a first position and a second position of the distal rod, the at least two electrode portions and the first electrode having a potential difference to form an electric field so as to collectively form a continuous ablation region surrounding the distal rod and in a concentric circular band shape;

The potential of the first electrode and the electrode portion is configured as one of the following configurations:

the polarity of the first electrode is a positive pulse and the polarity of the electrode portion is a negative pulse; or,

2. The electrode catheter of claim 1, further comprising an outer tube connected to the cage via a second end distal from the first end and configured to control the transition of the cage between the first state and the second state.

3. The electrode catheter of claim 1 or 2, wherein the at least two electrode portions are disposed on a half side of the cage proximate the first end and equidistant from the first electrode.

4. The electrode catheter of claim 1 or 2, wherein the cage is balloon-like or cone-like in the second state.

5. The electrode catheter of claim 1 or 2, wherein the at least two electrode portions are uniformly disposed on the cage-like support of the cage and at least a portion of the at least two electrode portions are exposed.

6. The electrode catheter of claim 1 or 2, wherein the cage-like support of the cage is configured to receive at least one of the at least three conductors.

7. The electrode catheter of claim 6, wherein the cage-like supports are uniformly disposed.

8. The electrode catheter of claim 6, wherein the cage stent comprises a central stent made of a deformable material.

9. The electrode catheter of claim 1 or 2, wherein the number of the at least two electrode portions is 6 to 10.

10. The electrode catheter of claim 1 or 2, further comprising a handle having an electrode power interface connected to the conductor and a fluid input/output port connected to the cage.

11. The electrode catheter of claim 1, further comprising a first electrode position control device configured to adjust a position of the first electrode on the distal shaft.

12. The electrode catheter of claim 1 or 2, further comprising an electrode cap disposed at a free end of the distal shaft, the electrode cap having a polarity different from a polarity of the first electrode.

13. An ablation device, the ablation device comprising:

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

the electrode catheter of any one of claims 1 to 12, which is electrically connected to the pulse signal generator.

14. The ablation device of claim 13, further comprising:

an operation control part configured to control the pulse signal generator and to manipulate the electrode catheter.