CN113081240B - Cage-shaped electrode catheter and ablation device comprising same - Google Patents

Cage-shaped electrode catheter and ablation device comprising same Download PDF

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CN113081240B
CN113081240B CN202110359595.XA CN202110359595A CN113081240B CN 113081240 B CN113081240 B CN 113081240B CN 202110359595 A CN202110359595 A CN 202110359595A CN 113081240 B CN113081240 B CN 113081240B
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electrode
cage
polarity
catheter
ablation
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CN113081240A (en
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王海峰
罗中宝
张星光
诸敏
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Shanghai Ruidao Medical Technology Co ltd
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Shanghai Remedicine Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345Vascular system
    • A61B2018/00351Heart
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/1407Loop
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1405Electrodes having a specific shape
    • A61B2018/144Wire
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B2018/1465Deformable electrodes

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Abstract

The present disclosure relates to an electrode catheter, including: a cage having a first state and a second state, the cage being capsuloid 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 groups of electrode parts which are arranged on a cage-shaped bracket of the cage-shaped object at intervals, wherein the number of the electrode parts in each group of the at least two groups of electrode parts is the same; and at least three conductors corresponding to and configured to power the at least two sets of electrode portions and the first electrode, wherein an electric field formed between the at least two sets of electrode portions is orthogonal to an electric field formed between the at least two sets of electrode portions and the first electrode.

Description

Cage-shaped 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 same.
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.
Disclosure of Invention
In view of the profound understanding of the problems with the background, that existing radiofrequency ablation is time consuming and has a consequent tissue destruction, and the cryoablation also causes problems such as embolism, the inventor of the present disclosure proposes an electrode catheter using a pulsed electric field ablation technique in the present case, the cage-shaped bracket of the cage-shaped object included in the electrode catheter is provided with electrodes which can be connected with different polarities, the distal rod connected with the cage-shaped object is provided with another electrode, the other electrode can generate effective mutually orthogonal pulse electric fields by matching with the electrode on the cage-shaped bracket of the cage-shaped object, the pulse electric field can be used for ablating target tissues in a targeted manner to form a continuous effective ablation zone, successfully block the adverse effect of noise signals on the heart rate of the heart, thereby avoiding the occurrence of atrial fibrillation and simultaneously reducing or even avoiding the damage to good tissue cells which do not need to be ablated.
Specifically, a first aspect of the present disclosure proposes an electrode catheter including:
a cage having a first state and a second state, the cage being capsuloid 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 groups of electrode parts which are arranged on a cage-shaped bracket of the cage-shaped object at intervals, wherein the number of the electrode parts in each group of the at least two groups of electrode parts is the same; and
at least three conductors corresponding to and configured to power the at least two sets of electrode portions and the first electrode, wherein an electric field formed between the at least two sets of electrode portions is orthogonal to an electric field formed between the at least two sets of electrode portions and the first electrode.
The present disclosure innovatively proposes to use not only electrodes capable of connecting different polarities arranged on a cage-like support of the cage, but also first electrodes arranged outside the cage, for example on distal rods provided on a first end of the cage, to form, for example, mutually orthogonal electric fields, so as to be able to ensure that ablation regions generated for target cells in different directions are, for example, ablation rings that are continuous in both the radial direction and the circumferential direction of a blood vessel, and to be able to successfully cut off a transmission path of a noise signal to the heart, thereby causing arrhythmia.
In one embodiment according to the present disclosure, the electrode catheter further includes an outer tube connected to the cage via a second end distal from the first end and configured to control the cage to transition between the first state and the second state. In this way, the operator of the electrode catheter can be facilitated to control the state of the cage.
In one embodiment according to the present disclosure, the at least two sets of electrode portions are disposed on a half side of the cage near the first end and at equal distances 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, minimizing damage to tissue that does not require ablation. In one embodiment according to the present disclosure, the electrode part provided on each of the cage-shaped brackets has a plurality of electrode sub-parts, 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 spheroidal or pyramidal-like bladder shape in the second state. Preferably, in one embodiment according to the present disclosure, the at least two sets of electrode portions are uniformly arranged on the cage-shaped support of the cage and at least a portion of each electrode portion of the at least two sets of electrode portions is exposed. Optionally or alternatively, in an embodiment according to the present disclosure, the cage support of the cage is configured to receive at least one conductor of the at least three conductors.
Preferably, in one embodiment according to the present disclosure, the cage-shaped brackets are uniformly arranged. Further preferably, in one embodiment according to the present disclosure, the cage support includes a central support made of a deformable material.
In one embodiment according to the present disclosure, a potential difference exists between the first electrode and each electrode portion of the at least two sets of electrode portions. In such a way that an electric field is formed between the first electrode and an 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-shaped electrode.
In one embodiment according to the present disclosure, a first set of electrode portions of the at least two sets of electrode portions has a first polarity and a second set of electrode portions of the at least two sets of electrode portions has a second polarity, wherein the first polarity and the second polarity are different and the first electrode has either the first polarity or the second polarity, wherein the potentials of the first polarity and the second polarity are configured in one of the following configurations:
the first polarity is a positive-negative alternating pulse and the second polarity is ground;
the first polarity is a positive or negative pulse and the second polarity is ground;
the first polarity is ground and the second polarity is alternating positive and negative pulses;
the first polarity is ground and the second polarity is a positive or negative pulse;
the first polarity is a positive pulse and the second polarity is a negative pulse; or
The first polarity is a negative pulse and the second polarity is a positive pulse.
In one embodiment according to the present disclosure, the polarity of the first electrode is switchable between said first polarity and said second polarity. In this way a more uniform ablation zone can be created in order to achieve a better ablation effect.
In one embodiment according to the present disclosure, the number of the at least two sets of 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 arranged at intervals in an axial direction of the cage stent.
In one embodiment according to the present disclosure, the electrode catheter further comprises a handle, and the handle is provided with an electrode power supply interface connected with the conductor and a fluid input/output port connected with the cage.
In one embodiment according to the present disclosure, 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.
In one embodiment according to the present disclosure, the electrode catheter further comprises a first electrode position control device configured to adjust a position of the first electrode on the distal shaft.
In one embodiment according to the present disclosure, the electrode catheter further includes an electrode cap disposed at the free end of the distal shaft, the electrode cap having a polarity different from a polarity of the first electrode.
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 electrode catheter according to the first aspect of the present disclosure, which is electrically connected with the pulse signal generator.
In summary, the present disclosure innovatively proposes that not only electrodes capable of connecting different polarities arranged on a cage-shaped stent of the cage are used, but also first electrodes arranged outside the cage, for example, arranged on a distal rod disposed on a first end of the cage, are applied to form mutually orthogonal electric fields, so that ablation regions generated for target cells in different directions can be ensured, for example, ablation rings continuous in the radial direction as well as in the circumferential direction of a blood vessel, and a transmission path for a noise signal to be conducted to the heart to cause arrhythmia can be successfully cut off.
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. 1 shows a schematic view of an electrode catheter 100 according to one embodiment of the present disclosure;
FIG. 2 shows a schematic view 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 illustrates an exploded view of an electrode catheter 400 according to yet another embodiment of the present disclosure;
FIG. 5 illustrates 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 the 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 the 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; and
fig. 12 shows a schematic view of the position of the electrode catheter 900 with the target tissue at the time of ablation by means of the electrode according to the disclosure.
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 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 PET ablation technique 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 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.
Further, the inventors of the present disclosure have recognized that there are problems in the prior art, namely: when electrical pulses are used to kill specific tissue cells, such as cardiomyocytes, each cardiomyocyte is typically elongate and thin, i.e. the lengths in the two directions are different. The cardiac tissue includes a plurality of cardiomyocytes assembled into myofibers of a conducting tissue. The spatial orientation of the muscle fibers depends to a large extent on their position in the heart. Different directions of electric field will produce different ablation effects on different directions of myocardial cells, i.e. the response of elongated cells to an applied electric field depends on the spatial orientation of the cells relative to the electric field. When the electrodes on the balloon are distributed in a positive and negative spacing mode, the electric field direction is single, namely, the electric field direction is along the weft direction of the balloon, and the ablation effect is poor.
In order to apply the pulsed electric field technique PET described above for ablation and to ablate target cells in different directions, a cage is used in the present disclosure to fix and shape the electrodes, the design is that the cage is small in volume and easy to extend into the target position in the first state (for example, the whole is in a contracted similar tubular state), and is switched into the second state (for example, the whole is in a saccular similar state with larger volume) after reaching the target position, so that the cage is easy to be attached, for example, the pulmonary vein ostia of one of the application scenarios is typically elliptical, while other target locations may have other shapes, although the target positions are different in shape, when the cage-shaped object is in a similar saccular state, the shape of the pulmonary vein opening can be changed, the pulmonary vein openings with different shapes are attached, and the attaching effect is good, so that the subsequent PET ablation effect is good. In addition, after the cage is in the second state, the contrast is obvious under X-rays, so that a doctor can easily observe the attaching condition with a target tissue, and the attaching effect can be further ensured; furthermore, after the cage is occluded with a target tissue such as the ostium of a pulmonary vein, the cage occlusion is observed and adjusted via intraluminal injectable contrast.
In addition to applying a cage that can be switched between a first state and a second state, the present disclosure also innovatively proposes to use not only electrodes arranged on the cage-like support of the cage that can be connected with different polarities, but also electrodes arranged outside the cage, for example on the distal rods provided on the first end of the cage, to form mutually orthogonal electric fields, so as to be able to ensure that the resulting ablation zone is a continuous ablation ring in the radial direction as well as in the circumferential direction of the pulmonary vein, ensuring that the transmission path of arrhythmia caused by the conduction of abnormal signals triggered or driven by ectopic excitations can be successfully cut off. Preferably, the electrode arranged on the distal rod 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 depending on the ablation effect. Further preferably, an electrode cover can be provided at the free end of the distal rod remote from the cage, the polarity of the electrode cover being different from the polarity of the first electrode, so that the extent of the ablation zone can be further adjusted, ensuring excellent ablation effect.
Specifically, the structure of the electrode catheter and the structure of the corresponding ablation apparatus according to the present disclosure will be described below with reference to fig. 1 to 11.
Fig. 1 shows a schematic view of an electrode catheter 100 according to one embodiment of the present disclosure. As can be seen in fig. 1, an electrode catheter 100 in accordance with the present disclosure includes a cage 110, a distal shaft 120, a first electrode 130, a plurality of electrode portions 141, 142, 143, 144, 145, 146, a plurality of conductors (not shown in fig. 1), and an outer tube 160. The plurality of electrode portions 141, 142, 143, 144, 145, 146 can be divided into two groups, for example, a first group of electrode portions includes the electrode portions 141, 143, 145, and a second group of electrode portions includes the electrode portions 142, 144, 146, for example. In some embodiments, the first set of electrode portions 141, 143, 145 shown in fig. 1 is only a portion of the first set of electrode portions, and similarly, the second set of electrode portions 142, 144, 146 shown in fig. 1 is also only a portion of the second set of electrode portions. In fact, the number of electrode portions of the first and second sets of electrode portions should be the same. 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 in the first state being similar to the shape and thickness of the left and right distal rods 120 and the outer tube 160. The cage 110 assumes a saccular-like shape in the second state shown in fig. 1. Furthermore, a distal rod 120 is arranged at a first end of the cage 110, in the illustration shown in fig. 1 on the left side of the cage 110, and a first electrode 130 for subsequent ablation by forming an electric field can be arranged on this distal rod 120. Furthermore, as can be seen from fig. 1, six electrode portions 141, 142, 143, 144, 145, 146 are shown arranged on the cage support of the cage 110. Here, it should be understood by those skilled in the art that six electrode portions are shown here, and that there are only two electrode portions to form a more desirable electric field with the first electrode 130 disposed on the distal rod 120 for ablation, i.e., the number of electrode portions is not limited too much. In one embodiment according to the present disclosure, as shown by the electrode portions 141 in fig. 1, each electrode portion includes a plurality of electrodes disposed at intervals along the axial direction of the cage-shaped stent.
In the example shown in fig. 1, the direction of the electric field formed between the first and second electrode portions is, for example, the latitudinal direction of the cage 110, and any one of the two electrode portions can form an electric field with the first electrode 130, and the electric field formed between any one of the electrode portions and the first electrode 130 is, for example, the longitudinal direction of the bladder 110, that is, the electric field formed between the at least two electrode portions and the first electrode are orthogonal to each other, so that when the direction of the target cell, such as a cardiomyocyte, is not determined, the target cell, such as a cardiomyocyte, can be effectively ablated as much as possible in each direction.
In addition to the components described above, the electrode catheter disclosed in accordance with the present disclosure includes, for example, a plurality of conductors, such as seven conductors in fig. 1. Here, it should be understood by those skilled in the art that the inner tube is, for example, seven wires, and the wires are only three wires, so that the wires can be used for a corresponding number of electrode portions and the first electrode, and further can form a perfect electric field for ablation by having a potential difference with the first electrode 130 and the plurality of electrode portions disposed on the distal rod 120, that is, the number of wires is not limited to be too large, but in principle, for example, seven wires correspond to the six electrode portions 141, 142, 143, 144, 145, 146 and the first electrode 130 and are configured to supply power to the six electrode portions 141, 142, 143, 144, 145, 146 and the first electrode 130. Furthermore, the conductors for supplying power to the first electrode 130 may be located, for example, within the inner tube 170 within the interior of 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 further include, for example, an outer tube 160, the outer tube 160 being connected to the cage 110 via a second end (e.g., an end of a right portion of the cage 110 in the direction shown in fig. 1) away from the first end (e.g., an end of a left portion of the cage 110 in the direction shown in fig. 1) and configured to control the cage 110 to switch between the first state and the second state. Before the cage 110 has not reached the target location, the cage 110 assumes, for example, a first state in which the size of the cage 110 is similar to the left and right distal rods 120 and the outer tube 160, thereby allowing the electrode catheter 100 with the cage 110 to be easily delivered to the target location, 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 is in an expanded saccular shape so as to fit the tissue to be ablated, and after the volume becomes larger, the position of the cage 110 can be finely adjusted, for example, through the outer tube 160, so that the cage can better fit the tissue to be ablated, and the treatment effect is further improved. It will be appreciated by those skilled in the art that assistance can also be provided during the above-described positioning procedure, for example by means of an X-ray machine or by means of a contrast technique, in order to position the tissue precisely, providing a guarantee for a good subsequent ablation effect.
Furthermore, after, for example, ablation is completed, the ablation effect can be evaluated first, and then it is decided whether a predetermined ablation effect is achieved, to further decide whether supplemental ablation is required or the electrode catheter 100 can be withdrawn. After a predetermined ablation effect is achieved, the cage 110 can be re-switched from the second state to the first state, for example, via the outer tube 160, prior to withdrawal of the electrode catheter 100, so that the electrode catheter 110 can be withdrawn with no or less trauma to the venous vessel through which it is passed.
As described above, the present disclosure innovatively proposes to form mutually orthogonal electric fields by using not only electrode portions capable of connecting different polarities arranged on a cage-shaped stent of the cage 110, but also the first electrodes 130 arranged outside the cage 110, for example, on the distal rod 120 arranged on the first end of the cage 110, so as to ensure that the generated ablation region is an ablation ring which is continuous in the radial direction as well as in the circumferential direction of the blood vessel, and to ensure that a transmission path of an arrhythmia caused by conduction of an abnormal signal triggered or driven by an ectopic focus can be successfully cut off. In order to achieve a better ablation effect, the first electrode arranged on the distal rod is preferably movable in the axial direction of the vessel, so that the extent of the ablation zone can be adjusted according to the ablation needs.
Fig. 2 shows a schematic view 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 according to the present disclosure includes a cage 210, a distal rod 220, a first electrode 230, a plurality of electrode portions 241, 242, 243, and an outer tube 260, and in addition, the electrode catheter 200 should include a plurality of conductors, such as wires, which can be disposed, for example, in a cage of the cage 210 or in 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 in the first state being similar to the shape and thickness of the left and right distal rods 220 and the outer tube 260. The cage 210 assumes a saccular-like shape in the second state shown in fig. 2. Furthermore, a distal rod 220 is arranged at a first end of the cage 210, at the end shown in fig. 2 to the left of the cage 210, and a first electrode 230 for forming an electric field for ablation can be arranged on the distal rod 220. As can be seen from fig. 2, three electrode portions 241, 242, 243 are shown arranged on the cage-like support of the cage 210. Here, it should be understood by those skilled in the art that three electrode portions are shown, and that electrode portions are also provided on the unseen back surface, and that there are only two electrode portions to form a desired electric field with the first electrode 230 provided on the distal end shaft 220 for ablation, i.e., the number of electrode portions is not limited to an excessive number. 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 spaced along an axial direction of the cage-shaped support.
In addition to the above-mentioned components, the electrode catheter 200 disclosed in the present disclosure further includes, for example, a plurality of conductors, and it will be understood by those skilled in the art that the number of the conducting wires depends on the number of the electrode portions and the arrangement of the first electrodes, and the number of the conducting wires corresponds to the corresponding number of the electrode portions and the first electrodes, so that the first electrode 230 and the plurality of electrode portions disposed on the distal rod 220 have a potential difference therebetween to form a more ideal electric field for ablation, i.e., the number of the conducting wires is not limited to an excessive number, but in principle, the conductors, such as the at least two conductors and the first electrode 230, correspond to the at least two sets of the electrode portions 241, 242, 243 and the first electrode 230 and are configured to supply power to the at least two sets of the electrode portions 241, 242, 243 and the first electrode 230. The plurality of electrode portions 241, 242, 243 can be divided into two groups, for example, a first group of electrode portions including the electrode portions 241 and 243 and a second group of electrode portions including the electrode portion 242. Here, the first group of electrode portions 241 and 243 shown in fig. 2 are only a part of the first group of electrode portions, and similarly, the second group of electrode portions 242 shown in fig. 2 are also only a part of the second group of electrode portions. In fact, the number of electrode portions of the first and second sets of electrode portions should be the same. As also previously mentioned, the conductor for supplying power to the first electrode 230 may be located, for example, within the inner tube 270 of the interior of the cage 210, not shown in fig. 2.
It will be appreciated by those skilled in the art that the above-described use of the outer tube 160 or the outer tube 260 to control the state of the cage 110 or the cage 210 is merely an example, and it is also possible that the cage 110 or the cage 210 itself has a state control part, which makes the cage 110 or the cage 210 in the first state or the second state by receiving a control signal, for example, instead of the outer tube 160 or the outer tube 260.
Furthermore, as can be seen from fig. 2, the first electrode 230 is configured to be movably disposed on the distal rod 220, for example, along the axial direction, between a first position (for example, a position shown by a left broken line in fig. 2) and a second position (for example, a position shown by a right broken line in fig. 2) of the distal rod 220, that is, the first electrode 230 is capable of moving within a stroke range formed by the distal rod 220 and marked by a symbol T in fig. 2. If a wider ablation zone is desired, the first electrode 230 may be positioned at the location identified by the dashed left-hand line further from the electrode portions 241, 242, and 243; conversely, if a more narrow ablation zone is desired, the first electrode 230 may be positioned closer to the electrode portions 241, 242, and 243 as indicated by the dashed right-hand line. Furthermore, as can be seen in fig. 2, there is a gap 272 in the distal shaft 220, through which gap 272 a pull wire present inside the inner tube 270 can supply power to the first electrode 230 and control the specific position of the first electrode 230 that moves over the stroke T.
To achieve accurate control of the position of the first electrode, the electrode catheter further comprises a first electrode position control device configured to adjust 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 electrode catheter 300 disclosed in accordance with the present disclosure includes a cage comprised of each cage support, which in turn includes, for example, a central support 312, which is made of, for example, a deformable material, such that the cage assumes a first state when, for example, the central support 312 assumes a straight state and a second state when the central support 312 assumes a raised state. In addition, the cage further includes an insulating layer 311, for example, which is sleeved outside the central support 312, and electrode portions 341 are uniformly disposed outside the insulating layer 311, for example, and these electrode portions 341 can be ring electrodes convenient for installation in this case, and can also be electrodes of other forms, such as patch electrodes. The conductors 350 for supplying power to the electrode portions 341 are provided, for example, inside the insulating layer 311, and the insulating layers 311 are opened at the mounting positions of the electrode portions 341 in order to supply power to the electrode portions 341 outside the insulating layer 311, thereby facilitating the electrical connection of the conductors 350 to the electrode portions 341 via the corresponding openings.
In addition, the electrode catheter 300 further includes a distal rod 320, a first electrode 330, a plurality of electrode portions 341, a plurality of conductors 350, and outer and inner tubes 360 and 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 in the first state is similar to the shape and thickness of the left and right distal rods 320 and the outer tube 360. The cage 310 assumes a saccular-like shape in the second state shown in fig. 3. In addition, a distal rod 320 is disposed at a first end of the cage 310, at the end shown in FIG. 3 to the left of the cage 310, and a first electrode 330, which is subsequently used to form an electric field for ablation, can be disposed on the distal rod 320.
As can be seen from fig. 3, the electrode 341 is shown disposed on the cage-like support of the cage 310. In addition to the above-mentioned components, the electrode catheter 300 disclosed according to the present disclosure includes, for example, a plurality of conductors, five conductors are shown in fig. 3, and it will be understood by those skilled in the art that the number of wires depends on the number of electrode portions and the arrangement of the first electrodes, and the number of wires corresponds to the corresponding number of electrode portions and the first electrodes, so that there is a potential difference between the first electrode and the plurality of electrode portions provided on the distal rod to form a more desirable electric field for ablation.
In addition to the above 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, for example in case the first electrode 330 is provided with a drive means, the first electrode position control means 371 is capable of, for example, issuing a control signal to the drive means provided with the first electrode 330, which drive means provided with the first electrode 330 then effects the desired position adjustment in dependence of the control signal.
Of course, the position adjustment can also be achieved by a mechanical driving manner of the first electrode position control device 371, for example, the first electrode position control device 371 can move in the axial direction relative to the outer tube 360 or the inner tube 370, so as to drive the first electrode 330 to move on the distal rod 320, and further adjust the position of the first electrode 330 on the distal rod 320. In one embodiment, the control 371 includes a pull wire that can be used as both a conductor to provide power to the first electrode 330 and as a control to effect the position adjustment in a mechanically driven manner. The distal rod 320 is provided with at least one slit in the axial direction 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 all 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 regions of the cages 110, 210, and 310, and are disposed at substantially equal distances from the first electrodes 130, 230, and 330. By the arrangement, the ablation effect can be ensured to be in accordance with 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 arranged at unequal distances from the first electrodes 130, 230 and 330, the further electrode portions will form additional ablation zones, which however have little practical effect, i.e. ablation of the zones is not necessary.
In addition, the cages 110, 210, and 310 are in the second state in the form of a spheroidal or spheroidal bladder. When high voltage pulses are used, the balloon-like ablation results are better because the spacing between the electrodes is wider, allowing for a wider ablation zone; in contrast, when low voltage pulses are used, the balloon-like ablation results are better because the ablation zone is not discontinuous due to the voltage drop because of the closer spacing between the electrodes. However, the cages 110, 210 and 310 of the present embodiment, whether they are balloon-like or balloon-like, do not have ablation blind areas in the ablating loop.
Furthermore, as can be seen from among the electrode catheters 100, 200 and 300 shown in fig. 1 to 3, the cage-shaped support is uniformly arranged, and the at least two sets of electrode portions are uniformly arranged on the cage-shaped support of the cages 110, 210 and 310 and at least a part of the at least two sets of electrode portions are exposed, for example at least a part of the at least two sets of electrode portions on a side away from the cages 110, 210 and 310 are exposed. In this manner, the exposed electrode portion is allowed to conform to the area to be ablated, thereby forming a suitable ablating loop in cooperation with the electrode disposed on the distal shaft. In performing a particular ablation, there is a potential difference between the first electrode 130 and each of the at least two sets of electrode portions 141, 142, 143, 144, 145 and 146 in fig. 1. Here, for example, the first electrode 130 is grounded, while the first group of electrode portions 141, 143, and 145 are connected to a positive pulse and the second group of electrode portions 142, 144, and 146 are connected to a negative pulse. It is also possible, for example, that the polarities of the first and second sets of electrode portions are different, while the polarity of the first electrode is the same as the polarity of one of the first and second sets of electrode portions 141, 143 and 145 and 142, 144 and 146. Accordingly, there is a potential difference between the first electrode 230 in fig. 2 and each of the at least two sets of electrode portions 241, 242 and 243, where, for example, the first electrode 230 in fig. 2 is grounded, while the first set of electrode portions 241 and 243 are connected to a positive pulse and the second set of electrode portions 242 are connected to a negative pulse. It is also possible, for example, for the first and second sets of electrode portions to be different in polarity, while the polarity of the first electrode is the same as the polarity of one of the first and second sets of electrode portions 241 and 243 and 242. There is a potential difference between the first electrode 330 in fig. 3 and each of the at least two sets of electrode portions 341, where, for example, the first electrode 330 in fig. 3 is grounded, while the first set of electrode portions 341 is connected to a positive pulse and the second set of electrode portions is connected to a negative pulse. It is also possible, for example, that the polarities of the first group of electrode portions and the second group of electrode portions (not shown) are different, and the polarity of the first electrode 330 is the same as the polarity of one of the first group of electrode portions 341 and the second group of electrode portions. So that an electric field is formed between the first electrode and the electrode part, and the subsequent ablation process is smoothly carried out.
Preferably, for example in the example of the electrode catheter 200 shown in fig. 2, the cage-like support of the cage 210 is configured for accommodating at least one conductor of the at least three conductors, for example a conductor, for example a lead wire, for supplying power to the electrode portions 241, 242 and/or 243. Such wires are not readily apparent from fig. 2, since they are accommodated in the cage-like support of the cage 210, whereas conductors such as wire 350 are readily apparent 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 for the cage 210, the conductors are well received therein, such that the surface of the cage-like support for the cage 210 may be flat despite the presence of the conductors therein, thereby facilitating implantation of the electrode catheter 200. As previously described, at least a portion of the electrode portions 241, 242, and 243 are exposed for use in an ablation procedure. While the other conductive parts need to be insulated to enable control of the ablated area, not left 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 away from the cage 210. Preferably, the entire conductor 350 can also be coated or wrapped with an insulator, such as insulation 311, on its outer surface.
As shown in fig. 1 and 2, the electrode portions 141, 142, 143, 144, 145, 146, 241, 242, 243 are substantially in the shape of an electrode ring, the long axes of the electrode portions 141, 142, 143, 144, 145, 146, 241, 242, 243 are arranged in the axial direction of the electrode catheter 100, 200 and the electrode portion length L is related to the preset shortest ablation width W in the axial direction of the vein and the ablation voltage V applied between the first electrode 130, 230 and the electrode portions 141, 142, 143, 144, 145, 146, 241, 242, 243. For example, the long axis of the electrode part 141, 142, 143, 144, 145, 146, 241, 242, 243 is disposed along the axial direction of the electrode catheter 100, 200 including the cage 110, 210, and the length L of the electrode part 141, 142, 143, 144, 145, 146, 241, 242, 243 is determined based on the preset ablation width W in the axial direction of the pulmonary vein and the ablation voltage V applied to the electrode part 141, 142, 143, 144, 145, 146, 241, 242, 243. Through simulation, in the case of different electrode part lengths L, for example, L is 3mm, 4mm, 5mm, 6mm or 7mm, the relationship between the ablation width W and the ablation voltage V exhibits, for example, the following relationship: the ablation width W is approximately linear with the ablation voltage V and can therefore be fitted using the following fitting function:
W=a1(L)V+a2(L) wherein a1(L) and a2(L) represents a function with respect to 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 first electrodes 130, 230, 330 can, for example, be of the same polarity as one of the first and second electrode portions, or of both electrode portions, and can, for example, be switched between two different polarities of the two electrode portions. Here, a first group of electrode portions of the at least two groups of electrode portions has a first polarity and a second group of electrode portions of the at least two groups of electrode portions has a second polarity, wherein the first polarity and the second polarity are different and the first electrode has either the first polarity or the second polarity, wherein the potentials of the first polarity and the second polarity are configured in one of the following configurations: the first polarity is a positive-negative alternating pulse and the second polarity is ground; the first polarity is a positive or negative pulse and the second polarity is ground; the first polarity is ground and the second polarity is alternating positive and negative pulses; the first polarity is ground and the second polarity is a positive or negative pulse; the first polarity is a positive pulse and the second polarity is a negative pulse; or the first polarity is a negative pulse and the second polarity is a positive pulse. Here, the number of the at least two electrode portions 141, 142, 143, 144, 145, 146, 241, 242, 243, and 341 may be, for example, 6 to 10, and preferably 8. Here, the at least two sets of electrode portions 141, 142, 143, 144, 145, 146, 241, 242, 243, 341 may be flexible electrodes.
FIG. 4 illustrates an exploded view of an electrode catheter 400 according to yet another embodiment of the present disclosure; it can be seen from fig. 4 that the electrode catheter 400 includes the electrode catheter 300 according to the present disclosure including a cage comprised of each cage support, which in turn includes, for example, a central support 412, which is made of, for example, a deformable material, such that the cage assumes a first state when, for example, the central support 412 assumes a straight state and a second state when the central support 412 assumes a raised state. In addition, the cage further includes an insulating layer 411, the insulating layer is sleeved outside the central support 412, for example, electrode portions 441 are uniformly arranged outside the insulating layer 411, and one or more electrode portions 441 can be ring electrodes convenient for installation in this case, and can also be electrodes in other forms, such as patch electrodes. While the conductors 450 for supplying power to these electrode portions 441 are provided, for example, inside the insulating layers 411, these insulating layers 411 have openings at the mounting positions of the electrode portions 441 in order to supply power to the electrode portions 441 outside the insulating layers 411, thereby facilitating the electrical connection of the conductors 450 to these electrode portions 441 via the respective openings.
In addition, the electrode catheter 400 further includes a distal rod 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 being shown in fig. 4, the cage 410 in the first state is similar to the shape and thickness of the left and right distal rods 420 and the outer tube 460. The cage 410 assumes a saccular-like shape in the second state shown in fig. 4. Furthermore, a distal rod 420 is arranged at a first end of the cage 410, at the end shown in fig. 4 to the left of the cage 410, and a first electrode 430 for subsequent formation of an electric field for ablation can be arranged on the distal rod 420.
As can be seen from fig. 4, the electrode 441 is shown arranged on a cage-like support of the cage 410. In addition to the above-mentioned components, the electrode catheter 400 disclosed according to the present disclosure includes, for example, a plurality of conductors, five conductors are shown in fig. 4, and it will be understood by those skilled in the art that the number of wires depends on the number of electrode portions and the arrangement of the first electrodes, and the number of wires corresponds to the corresponding number of electrode portions and the first electrodes, so that there is a potential difference between the first electrode and the plurality of electrode portions provided on the distal rod to form a more desirable electric field for ablation.
In addition to the above components, it can be seen from fig. 4 that the electrode catheter 400 further comprises a first electrode position control device 471, wherein the first electrode position control device 471 is configured to adjust the position of the first electrode 430 on the distal rod 420, for example, in the case of the first electrode 430 with its own driving device, the first electrode position control device 471 can, for example, send a control signal to the own driving device of the first electrode 430, and then the own driving device of the first electrode 430 can realize the desired position adjustment according to the control signal.
Of course, the above-mentioned position adjustment can also be achieved by a mechanical driving manner of the first electrode position control device 471, for example, the first electrode position control device 471 can move in the axial direction relative to the outer tube 460 or the inner tube 470, so as to drive the first electrode 430 to move on the distal rod 420, and further adjust the position of the first electrode 430 on the distal rod 420. In one embodiment, the control device 471 includes a pull wire, which can be used as a conductor to supply power to the first electrode 430, or as a control device to achieve the position adjustment in a mechanically driven manner. The distal rod 420 is provided with at least one slit in the axial direction through which the pull wire is connected to the first electrode 430.
In addition to the above structure, a tip end of the distal rod 420 such as a support may be added with an electrode cover 425, the electrode cover 425 and the electrode ring 430 form an electric field, for supplementary ablation when an ablation region formed by ablation by the electric field between the electrode portion 441 and the electrode ring 430 on the cage-shaped support of the cage 510 is incomplete. The wires of the electrode cap 425 in one embodiment are connected to the handle via an internal tube within the distal stem. In the present disclosure, the electrode ring 430 can be moved back and forth as needed for ablation to vary the ablation field area, for example, to extend the ablation area axially inward of the pulmonary vein ostium. The polarity of the electrode cover 425 is different from that of the first electrode, i.e., the electrode ring 430, so that the range of the ablation zone can be further adjusted to ensure excellent ablation effect.
In the embodiment according to the present disclosure, the cage support of the cage 110, 210, for example, the insulating layer 311, 411 included therein, may be made of PEBAX, PET, Nylon, TPU, or other insulating materials. While the cross-section of the conductors 350, 450 can be, for example, circular or rectangular; the electrode portions 141, 142, 143, 144, 145, 146, 241, 242, 243, 341, 441 are in the shape of an electrode ring, the electrode portions 141, 142, 143, 144, 145, 146, 241, 242, 243, 341, 441, 541 are uniformly distributed on 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 field of medical devices, 3Fr ≈ 1mm, and the outer tube 160, 260, 360, 460 can be single lumen or multi-lumen; the inner tube is a mapping electrode catheter/guidewire/contrast injection channel. The connection of the supporting piece and the cage-shaped object and the connection of the cage-shaped object and the outer pipe can adopt glue or a hot melting welding process; the supporting piece and the inner tube, the electrode part and the cage-shaped object, and the conductor and the cage-shaped object can be connected by glue, and the glue is preferably UV glue. Furthermore, the electrode catheter 100, 200, 300, 400 can preferably also comprise a handle, which can be connected, for example, to the outer tube 160, 260, 360 and 460, and on which an electrode power 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 according to 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 labeled), a pull wire (not labeled), a cage 510, an electrode portion (not labeled), a wire (not labeled), a covering of the wire (not labeled), an inner tube (not labeled), and an outer tube (not labeled). 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 ostial positioning; the electrode ring is placed in the distal neck of cage 510, and this electrode ring can be controlled by the traction wire and move a certain distance along the axial, and then realize the portable setting of electrode ring, and the traction wire is as the draw gear and the voltage transmission wire of electrode ring simultaneously. The pull wire is connected to the electrode ring via an axially disposed slit in the support member 520 and extends along the lumen of the inner tube to a handle (not shown in fig. 5), a cage-like support of the cage 510 extends to the proximal end 580 of the balloon 510 and embeds the wire, securing an electrode portion, which can be, for example, a flexible electrode or an inert metal electrode, to the cage-like support of the cage 410, a covering of the wire covering the wire, which can be, for example, a film or glue.
Fig. 6 shows an enlarged view of the first end of the electrode catheter 500 in fig. 5. As can be seen from fig. 6, an electrode ring 530 can be disposed at the distal rod 520, and the electrode ring 530 is powered and pulled by a pulling wire 571, so as to change the position of the electrode ring 530 on the distal rod 520, thereby adjusting the ablation effect. In another case, the electrode catheter 500 further comprises a first electrode position control device 571, wherein the first electrode position control device 571 is configured to adjust the position of the first electrode 530 on the distal shaft 520, for example, in the case of the first electrode 530 with its own driving device, the first electrode position control device 571 can send a control signal to the own driving device of the first electrode 530, for example, and then the own driving device of the first electrode 530 can achieve the desired position adjustment according to the control signal.
Fig. 7 shows an enlarged view of the second end of the electrode catheter 500 from 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, while 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 and the corresponding electrode rings 530 and the possible motor covers can be supplied with power. In addition, proximal end 580 has a proximal anchor thereon to secure the structures together.
Fig. 8 shows a perspective view of a first electrode of the electrode catheter 500 in fig. 5. As can be seen from fig. 8, the ring electrode 530 includes a ring wire holder 572 connected thereto, and the ring electrode 530 is powered by the ring wire holder 572 and is mechanically position-controlled by the ring wire holder 572. In another case, 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, for example, in the case of the ring electrode 530 having a drive device, the first electrode position control device can send a control signal to the electrode ring wire holder 572, for example, to the drive device of the ring electrode 530, and the drive device of the ring electrode 530 can then adjust the desired position according to 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 positioning slot 522 thereon, the electrode ring positioning slot 522 defining two extreme positions of the position in which the ring electrode 530 can move back and forth across the distal rod, the two extreme positions defining the movable position range of the ring electrode 530. In addition, the distal shaft 520 includes an electrode ring runner 521, and the ring-shaped electrode 530 can be powered and position-controlled by conductors passing through the electrode ring runner 521. Further, the distal rod 520 further includes a fixing hole 523 for a flexible cage holder of the cage 510, in which the flexible cage holder constituting the cage 510 can be received to be fixed at the distal rod 520. Correspondingly, there are also fastening holes in the proximal end 580 for the flexible cage support of the cage 510, in which the flexible cage support forming the cage 510 can be received for fastening at the proximal end 580.
In correspondence therewith, fig. 10 shows a schematic view of the inner tube 570 of the electrode catheter 500 in fig. 5. As can be seen from the figure, the inner tube 570 has a receiving groove 573 for a pull wire of the electrode ring 530 near the handling end, and an electrode ring slide hole 574 at a position corresponding to the mounting 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 slide hole 574 via the pull wire received in the receiving groove 573.
Fig. 11 shows a schematic view of an ablation device 1000 in accordance with an embodiment of the present disclosure. That is, the present disclosure also relates to an ablation apparatus 1000 for performing irreversible electroporation, the ablation apparatus 1000 having a pulse signal generator configured to generate a pulse signal (not shown in the drawings), the electrode catheter 600 being connected to a pulse signal generation module and transmitting the pulse signal to a target location through an electrode ring and an electrode portion of the electrode catheter 600. Furthermore, the ablation device 1000 further comprises an electrode catheter 600 according to the above, said electrode catheter 600 being electrically connected to said pulse signal generator. Still further, optionally, the ablation device 1000 can further include an operation control part 800, the operation control part 800 (e.g., the aforementioned handle) being configured to control the pulse signal generator and manipulate the electrode catheter 600. Furthermore, as can also be seen in fig. 6, the ablation device 1000 can also include, for example, four interfaces 700, which four interfaces 700 integrate, for example, a positive and negative electrical cable interface, a mapping electrode catheter 600/guidewire/contrast access interface, and a gas/liquid injection interface.
In a particular use of the ablation device 1000 shown in fig. 6, a vascular sheath is first placed into the bilateral femoral vein, for example, using a femoral venipuncture. The coronary sinus electrode is sent to the right position through the left sheath tube; performing atrial septal puncture and left atrial and pulmonary vein angiography through the right femoral vein; then, replacing the pulse ablation delivery system; then, the electrode catheter 600 including the cage and the mapping catheter are sent; then, mapping the catheter into a target vein of interest; next, the cage 600 is switched to the second state and positioned; finally, the pulmonary vein ostia are blocked by the cage 600 and ablation is performed. In a specific ablation procedure, for example, three-stage ablation can be performed, the first stage forming an electric field in the dimension direction of the cage 600, for example, only by means of two sets of electrode pads arranged on the cage 600; then next in a second phase ablation is performed, for example by means of a first electrode and a first set of electrode pads forming an electric field in the longitudinal direction of the cage 600; the final third stage performs ablation, for example, by means of the first and second sets of electrode pads forming an electric field in the longitudinal direction of the cage 600.
Fig. 12 shows a schematic position diagram of an electrode catheter 900 and a target tissue during ablation according to the present disclosure, an ablation region 902 in a concentric circular band shape can be formed by means of ablation of an electrode arranged on a cage-shaped support of a cage of the electrode catheter 900 and a first electrode arranged on a distal rod, the ablation region 902 is located between an unablated region 901 and an unablated region 903, the ablation width of the ablation region 902 is uniform, and the ablation region is continuously closed, i.e., a discontinuous region is not formed in the middle, so that a transmission path of a noise signal to the heart to cause arrhythmia can be successfully cut off.
In summary, the present disclosure innovatively proposes that not only electrodes capable of connecting different polarities arranged on a cage-shaped stent of the cage are used, but also first electrodes arranged outside the cage, for example, arranged on a distal rod disposed on a first end of the cage, are applied to form mutually orthogonal electric fields, so that ablation regions generated for target cells in different directions can be ensured, for example, ablation rings continuous in the radial direction as well as in the circumferential direction of a blood vessel, and a transmission path of arrhythmia caused by conduction of abnormal signals triggered or driven by ectopic excitation can be successfully cut off.
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 substituted as appropriate 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 (19)

1. An electrode catheter, characterized in that the electrode catheter comprises:
a cage having a first state and a second state, the cage being capsuloid 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 groups of electrode parts which are arranged on a cage-shaped bracket of the cage-shaped object at intervals, wherein the number of the electrode parts in each group of the at least two groups of electrode parts is the same; and
at least three conductors corresponding to and configured to power the at least two sets of electrode portions and the first electrode, wherein an electric field formed between the at least two sets of electrode portions is orthogonal to an electric field formed between the at least two sets of electrode portions and the first electrode that is capable of ablating a target tissue.
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 cage to transition between the first state and the second state.
3. The electrode catheter of claim 1 or 2, wherein the at least two sets of 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 as claimed in claim 1 or 2, wherein the at least two sets of electrode portions are uniformly arranged on the cage-like support of the cage and at least a portion of each electrode portion of the at least two sets of electrode portions is exposed.
6. The electrode catheter of claim 1 or 2, wherein the cage support of the cage is configured to receive at least one conductor of the at least three conductors.
7. The electrode catheter of claim 6, wherein the cage-like scaffold is uniformly disposed.
8. The electrode catheter of claim 6, wherein the cage support includes a central support made of a deformable material.
9. The electrode catheter of claim 1 or 2, wherein a potential difference exists between the first electrode and each electrode portion of the at least two sets of electrode portions.
10. The electrode catheter of claim 9, wherein the first electrode is configured as a ring electrode.
11. The electrode catheter of claim 9, wherein a first set of electrode portions of the at least two sets of electrode portions has a first polarity and a second set of electrode portions of the at least two sets of electrode portions has a second polarity, wherein the first polarity and the second polarity are different and the first electrode has either the first polarity or the second polarity, wherein the potentials of the first polarity and the second polarity are configured in one of the following configurations:
the first polarity is a positive-negative alternating pulse and the second polarity is ground;
the first polarity is a positive or negative pulse and the second polarity is ground;
the first polarity is ground and the second polarity is alternating positive and negative pulses;
the first polarity is ground and the second polarity is a positive or negative pulse;
the first polarity is a positive pulse and the second polarity is a negative pulse; or
The first polarity is a negative pulse and the second polarity is a positive pulse.
12. The electrode catheter of claim 11, wherein the polarity of the first electrode is switchable between the first polarity and the second polarity.
13. The electrode catheter according to claim 1 or 2, wherein the number of the at least two sets of electrode portions is 6 to 10, preferably 8.
14. The electrode catheter of claim 1 or 2, further comprising a handle, wherein the handle is provided with an electrode power supply interface connected to the conductor and a fluid input/output port connected to the cage.
15. The electrode catheter of claim 1 or 2, 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.
16. The electrode catheter of claim 15, further comprising a first electrode position control device configured to adjust a position of the first electrode on the distal shaft.
17. The electrode catheter of claim 1 or 2, further comprising an electrode cap disposed at the free end of the distal rod, the electrode cap having a polarity different from the polarity of the first electrode.
18. An ablation device, characterized in that the ablation device comprises:
a pulse signal generator configured to generate a pulse signal; and
the electrode catheter of any one of claims 1 to 17, which is electrically connected with the pulse signal generator.
19. The ablation apparatus of claim 18, further comprising:
an operation control part configured to control the pulse signal generator and manipulate the electrode catheter.
CN202110359595.XA 2021-03-31 2021-04-02 Cage-shaped electrode catheter and ablation device comprising same Active CN113081240B (en)

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