CN115813526B

CN115813526B - Electrophysiology catheter and high-voltage pulse ablation system

Info

Publication number: CN115813526B
Application number: CN202310127332.5A
Authority: CN
Inventors: 周磊; 曹海朋; 郭东杰; 史胜凤; 薛卫
Original assignee: Shanghai Antaike Medical Technology Co ltd
Current assignee: Shanghai Antaike Medical Technology Co ltd
Priority date: 2023-02-17
Filing date: 2023-02-17
Publication date: 2023-06-30
Anticipated expiration: 2043-02-17
Also published as: CN115813526A; CN116407261A; CN116687544A

Abstract

The invention provides an electrophysiology catheter and a high-voltage pulse ablation system, wherein the electrophysiology catheter comprises a catheter shaft and an electrode section, and the electrode section is arranged at the distal end section of the catheter shaft; the electrode segment comprising an end electrode and an electrode assembly, the electrode assembly being closer to the proximal end of the catheter shaft than the end electrode; the electrode assembly comprises at least one electrode carrier and a plurality of electrodes positioned on the electrode carrier, when the end electrode ablates the target tissue, the end electrode is paired with at least one electrode for discharge, and at least one electrode of the electrodes participating in paired discharge is positioned on the side surface of the electrode carrier close to the catheter shaft. When the end electrode is used for ablating target tissues, the electrode matched with the electrode can be opposite to non-target tissues or at least difficult to contact with the non-target tissues, and the electrode matched with the electrode can be prevented from acting on the non-target tissues to form an unexpected ablation focus.

Description

Electrophysiology catheter and high-voltage pulse ablation system

Technical Field

The invention relates to the technical field of medical instruments, in particular to an electrophysiology catheter and a high-voltage pulse ablation system.

Background

Atrial fibrillation (abbreviated as atrial fibrillation) is one of the most common cardiac arrhythmias in clinic. Pulsed electric field ablation is a newer method of atrial fibrillation ablation, which delivers pulsed electric fields to myocardial tissue through catheter electrodes. The pulsed electric field may cause irreversible electroporation of cells to increase cell permeability, causing cell death to form an ablation focus. Compared with the traditional radio frequency ablation and cryoablation, the pulsed electric field ablation technology is a non-thermal effect ablation technology, and the characteristics of cell selectivity of the pulsed electric field ablation technology enable the pulsed electric field ablation technology to have better safety in the field of atrial fibrillation treatment.

The pulse electric field ablation operation is performed by vascular intervention operation, after the head end (distal end) of a catheter is inserted into a human body to reach a corresponding treatment target position, an energy medium (such as energy of radio frequency, ultrasound, pulse and the like) is sent through an energy platform connected with the tail end (proximal end) of the catheter, an energy conveying electrode is arranged at the distal end of the catheter, and the energy is transferred to tissues after the electrode is abutted against the tissues, so that tissue ablation is performed.

The catheter structure is mainly composed of electrode assemblies of polymer tubes matched with annular electrodes, a certain number of electrode assemblies are circumferentially arranged on a catheter shaft to form electrode segments, and the electrode segments are converted among a contracted state, a basket state and a petal state through relative movement of the catheter shaft, so that the aim of adapting to different vascular anatomy structures is fulfilled, and treatment is better carried out. Meanwhile, in order to make up for the treatment requirement that the electrode section cannot meet the small-area ablation, an end electrode is arranged at the distal end of the electrode section, the ablation mode of the end electrode is a monopolar mode and a multipolar mode, the monopolar mode is used for treating by forming energy transmission between the end electrode of the target ablation position and a reference electrode on the surface of a body, and the multipolar mode is used for treating by forming energy transmission between the end electrode of the catheter and an annular electrode of the electrode section. In actual atrial fibrillation, the ring electrode would typically be suspended in the blood when the end electrode is against the intended site in multipolar mode, but with some probability against an unintended ablation site. When pulse voltage is applied, high-intensity electric fields are formed at the end electrode and the annular electrode, so that a certain probability exists that an unintended ablation part which is abutted against the annular electrode is ablated, and complications are formed.

Besides the catheter electrode section structure of the polymer matched ring electrode, the electrode section formed by taking the flexible circuit board as an electrode carrier is also used in the catheter structure design of atrial fibrillation treatment. The flexible circuit board is affected by the manufacturing technology, and the material has poor torsion resistance and bending resistance. When the flexible circuit board is used as an electrode segment carrier, the shape change is limited, particularly when the electrode segment is changed into a petal shape, the joint of the electrode segment and the head electrode is bent to form a smaller curvature radius, so that stress is concentrated, and the bending fatigue performance of the flexible circuit is reduced.

Disclosure of Invention

The invention aims to provide an electrophysiology catheter and a high-voltage pulse ablation system, which are used for solving at least one of the technical problems in the prior art or related technologies.

To achieve the above object, in a first aspect, the present invention provides an electrophysiology catheter, comprising a catheter shaft and an electrode section, the electrode section being disposed at a distal section of the catheter shaft;

the electrode segment comprising an end electrode and an electrode assembly, the electrode assembly being closer to the proximal end of the catheter shaft than the end electrode;

the electrode assembly comprises at least one electrode carrier and a plurality of electrodes positioned on the electrode carrier, when the end electrode ablates the target tissue, the end electrode is paired with at least one electrode for discharge, and at least one electrode of the electrodes participating in paired discharge is positioned on the side surface of the electrode carrier close to the catheter shaft.

Optionally, the electrode assembly comprises a number of inner electrodes on the side of the electrode carrier close to the catheter shaft, the inner electrodes comprising the at least one of the electrodes participating in the paired discharge.

Optionally, the inner electrode has a position disposed toward a distal end of the catheter shaft.

Optionally, the electrode carrier where the at least one electrode of the electrodes participating in the paired discharge is located and the electrode carrier electrically connected with the end electrode are different electrode carriers.

Optionally, electrode carriers where the at least one electrode of the electrodes participating in the paired discharge is located and electrode carriers where the end electrodes are electrically connected are alternately arranged in the circumferential direction of the catheter shaft.

Optionally, the inner electrode has at least a first position and a second position;

in the first position, an electrode carrier where the inner electrode is positioned is in a contracted state, and the electrode carrier is folded towards the catheter shaft;

in the second position, the electrode carrier is in an expanded state, at least a portion of the electrode carrier moves from a position of collapsing toward the catheter shaft to a position away from the catheter shaft, and the inner electrode is toward the distal end of the catheter shaft.

Optionally, the electrode assembly further comprises a number of outer electrodes on a side of the electrode carrier facing away from the catheter shaft, the outer electrodes being closer to the end electrode than the inner electrodes.

Optionally, the inner electrode has at least a third position in which the electrode carrier on which the inner electrode is located is in an expanded state, and at least a portion of the inner electrode and at least a portion of the outer electrode act on and ablate the target tissue.

Optionally, the electrode carrier of the electrode assembly includes a carrier proximal end and a carrier distal end, the carrier proximal end and the carrier distal end being capable of relative movement to switch the electrode carrier of the electrode assembly between a contracted state and an expanded state.

Optionally, the electrophysiology catheter further comprises at least one stress diffuser disposed on at least one of the carrier proximal end and the carrier distal end, the stress diffuser being capable of distributing stress acting on the at least one of the carrier proximal end and the carrier distal end in the expanded state.

Optionally, the stress-dispersing member is sleeved on at least one of the proximal carrier end and the distal carrier end, and in the expanded state, at least a portion of the stress-dispersing member is deformed by the at least one of the proximal carrier end and the distal carrier end.

Optionally, the electrophysiology catheter further comprises a shaping member disposed within the electrode assembly, the shaping member being disposed over the catheter shaft, the shaping member acting on at least one of the proximal carrier end and the distal carrier end in a contracted state and causing the at least one of the proximal carrier end and the distal carrier end to protrude outwardly away from the catheter shaft.

Optionally, the catheter shaft comprises an inner shaft and an outer tube, the inner shaft and the outer tube being relatively movable, the carrier proximal end being disposed on the outer tube, the carrier distal end being disposed on the inner shaft;

the shaping member is disposed on the inner shaft adjacent the distal end of the carrier.

Optionally, the shaping member is of a reducing structure, so that the electrode carrier forms a predetermined working shape.

Optionally, at least one of the distal end and the proximal end of the shaping member has a radial dimension that is no greater than the inner diameter of the circle in which the ends of the electrode carrier are located.

Optionally, the length of the shaping piece is between 1mm and 5mm.

Optionally, the shaping member is spaced from a gathering member disposed on the catheter shaft for gathering the distal end of the carrier by no more than 5mm.

Optionally, the at least one electrode carrier of the electrode assembly includes a transmission line electrically connected with the electrode of the electrode assembly and a blind line electrically connected with the power supply unit and forming no electrical circuit;

when the electrode assembly works normally, the blind circuit and the transmission circuit are not electrically conducted; when the electrode carrier breaks, the blind circuit is electrically connected with the transmission circuit and forms an electrical circuit with the energy supply unit.

Optionally, the electrode carrier further includes an insulating layer and a substrate, the transmission line is disposed on the insulating layer, the substrate covers the transmission line, and the electrode is disposed on the other side of the substrate with respect to the transmission line and is electrically connected to the transmission line.

Optionally, the blind line extends along the extension direction of the electrode carrier at least from the carrier proximal end of the electrode carrier to a maximum bend of the carrier distal end of the electrode carrier in the expanded state.

Optionally, the blind line is disposed closer to the outside of the electrode carrier than the transmission line.

Optionally, there are a plurality of electrode carriers electrically connected to the end electrodes.

Optionally, a superelastic memory alloy is disposed in at least one electrode carrier of the electrode assembly to enhance its shape retention capability.

In a second aspect, the present invention provides a high voltage pulse ablation system comprising an energy supply unit, a main control module, an electrode combination switch, a user interface and an electrophysiological catheter as described above;

the main control module is used for sending a working instruction;

the energy supply unit is in communication connection with the main control module and is used for conveying high-voltage pulses to the electrode section of the electrophysiology catheter according to the working instruction;

the electrode combination switch is in communication connection with the main control module and is used for selecting a transmission line of an electrode carrier of the electrode assembly needing to transmit energy according to the working instruction so as to realize paired discharge of the electrode segments;

the user interface is in communication connection with the main control module and is used for performing man-machine interaction to control the high-voltage pulse ablation system and display information.

Optionally, the high-pressure pulse ablation system includes at least one of the following modes of operation:

in a first mode of operation, ablation is performed through the tip electrode;

in a second mode of operation, the electrode segments are in an expanded state, ablation being performed by the end electrodes and/or the outer electrodes of the electrode assembly;

In a third mode of operation, the electrode segments are in an expanded state, and ablation is performed through the inner electrode of the electrode assembly and/or the outer electrode of the electrode assembly.

Optionally, the main control module is capable of selectively controlling the end electrode, the outer electrode, and the inner electrode.

In a third aspect, the present invention provides a high voltage pulse ablation system comprising an energy supply unit, a main control module, an electrode combination switch, a user interface and an electrophysiological catheter as described above;

the main control module is used for sending a working instruction;

the electrode combination switch is in communication connection with the main control module and is used for selecting the transmission line which needs to transmit energy according to the working instruction so as to realize the pairing discharge of the electrode sections;

the user interface is in communication connection with the main control module and is used for performing man-machine interaction to control the high-voltage pulse ablation system and display information;

the energy supply unit is also used for electrifying the blind circuit and the transmission lines needing to be discharged, so that the polarity of the blind circuit is opposite to the polarity of at least one transmission line;

The ablation system further comprises a cracking detection module in communication connection with the main control module, wherein the cracking detection module is used for detecting whether the blind circuit is conducted with the transmission circuit or not, and if so, a cracking signal is sent to the main control module.

Optionally, the energy supply unit delivers a high voltage pulse to the blind circuit.

Optionally, the energy supply unit further includes a low-voltage generator, and in a non-discharge state, the electrode combination switch can be switched to be conducted with the low-voltage generator, and two poles of the low-voltage generator are respectively and electrically connected with the blind circuit and at least one transmission circuit.

In a fourth aspect, the present invention provides a catheter for treating a target tissue, comprising a catheter shaft and a basket structure disposed at a distal section of the catheter shaft, the basket structure having a contracted state and an expanded state, the basket structure being collapsed toward the catheter shaft in the contracted state to ensure that the catheter can safely reach the region of the target tissue; in the expanded state, at least a portion of the basket structure moves from a position collapsed toward the catheter shaft to a position remote from the catheter shaft;

The basket structure comprises a basket proximal end and a basket distal end, the basket proximal end and the basket distal end being capable of relative movement to switch the basket structure between the contracted state and the expanded state;

at least one stress diffuser is disposed on at least one of the proximal basket end and the distal basket end, the stress diffuser being capable of distributing stress on the at least one of the proximal basket end and the distal basket end in the expanded state.

Optionally, the stress dispersing member is sleeved on at least one of the proximal end of the basket and the distal end of the basket, and in the expanded state, at least a portion of the stress dispersing member is deformed by the at least one of the proximal end of the basket and the distal end of the basket.

Optionally, the catheter further includes a shaping member disposed within the basket structure, the shaping member being disposed over the catheter shaft, the shaping member acting on at least one of the proximal basket end and the distal basket end in the collapsed condition and causing the at least one of the proximal basket end and the distal basket end to protrude outwardly away from the catheter shaft.

Optionally, the catheter shaft comprises an inner shaft and an outer tube, the inner shaft and the outer tube being capable of relative movement, the proximal end of the basket being disposed on the outer tube, the distal end of the basket being disposed on the inner shaft; the shaping member is disposed on the inner shaft adjacent the basket distal end.

Optionally, the length of the shaping piece is between 1mm and 5mm.

Optionally, a distance between the shaping member and a furling member disposed on the catheter shaft for furling the distal end of the basket is no greater than 5mm.

Optionally, the basket structure includes a superelastic memory alloy to enhance the shape retention capability of the basket structure.

In a fifth aspect, the present invention provides a catheter for treating a target tissue, comprising a catheter shaft and a basket structure disposed at a distal section of the catheter shaft, the basket structure having a contracted state in which the basket structure is collapsed toward the catheter shaft to ensure that the catheter can safely reach the region of the target tissue, and an expanded state; in the expanded state, at least a portion of the basket structure moves from a position collapsed toward the catheter shaft to a position remote from the catheter shaft;

the catheter further comprises a shaping piece arranged in the basket structure, the shaping piece is sleeved on the catheter shaft, and in the contracted state, the shaping piece acts on at least one of the proximal basket end and the distal basket end and enables the at least one of the proximal basket end and the distal basket end to be outwards protruded away from the catheter shaft.

Optionally, the catheter shaft includes an inner shaft and an outer tube, the inner shaft and the outer tube being capable of relative movement, the proximal basket end being disposed on the outer tube, the distal basket end being disposed on the inner tube;

the shaping member is disposed on the inner tube adjacent the basket distal end.

Optionally, the length of the shaping piece is between 1mm and 5 mm.

In a sixth aspect, the present invention provides an electrode carrier that is capable of being disposed at a distal section of a catheter and includes a transmission line that is electrically connected to an electrode and a blind line that is electrically connected to an energy supply unit and that does not form an electrical circuit;

when the electrode carrier works normally, the blind circuit and the transmission circuit are not electrically conducted; when the electrode carrier is cracked, the blind circuit is electrically conducted with the transmission circuit and forms an electrical circuit with the power supply unit.

Optionally, the electrode carrier further includes an insulating layer and a substrate, the transmission line is disposed on the insulating layer, the substrate covers the transmission line, and the electrode is disposed on the other side of the substrate with respect to the transmission line and is electrically connected with the transmission line.

Optionally, a superelastic memory alloy is arranged in the electrode carrier to improve the shape retaining capability.

In a seventh aspect, the present invention provides an electrophysiology catheter for ablating target tissue, comprising a catheter shaft and an electrode assembly disposed at a distal section of the catheter shaft;

the electrode assembly comprises an electrode carrier as described above and the electrode on the electrode carrier.

Optionally, the electrodes include an inner electrode on a side of the electrode carrier adjacent the catheter shaft and an outer electrode on a side of the electrode carrier facing away from the catheter shaft, the outer electrode being closer to a distal end of the catheter shaft than the inner electrode.

In an eighth aspect, the present invention provides a high voltage pulse ablation system comprising an energy supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiological catheter as described above;

the main control module is used for sending a working instruction;

the energy supply unit is in communication connection with the main control module and is used for conveying high-voltage pulses to the electrode assembly according to the working instructions;

The electrode combination switch is in communication connection with the main control module and is used for selecting the transmission line which needs to transmit energy according to the working instruction so as to realize the pairing discharge of the electrode assemblies;

In the electrophysiology catheter and the high-voltage pulse ablation system provided by the invention, at least one of the following beneficial effects is achieved:

1) By positioning at least one of the electrodes involved in the paired electrical discharge on the side of the electrode carrier that is closest to the catheter shaft, the electrodes involved in the paired electrical discharge can be made to face away from or at least be difficult to contact non-target tissue when ablating the target tissue with the end electrode, thereby preventing the electrodes involved in the paired electrical discharge from acting on the non-target tissue to form an unintended ablation focus;

2) By arranging the stress dispersing element on at least one of the carrier proximal end and the carrier distal end, in the expanded state, the stress dispersing element can disperse stress acting on the at least one of the carrier proximal end and the carrier distal end, the bending radius of the electrode carrier corresponding to the position of the stress dispersing element is increased, and stress concentration is prevented, so that the electrode carrier is prevented from being cracked;

3) By providing a shaping member within the electrode assembly, the shaping member is sleeved on the catheter shaft, and in a contracted state, the shaping member acts on at least one of the proximal carrier end and the distal carrier end and projects the at least one of the proximal carrier end and the distal carrier end outwardly away from the catheter shaft. When the electrode assembly acts on a curved blood vessel, the shaping piece is sleeved on the catheter shaft adjacent to the distal end of the carrier and/or the proximal end of the carrier, so that the electrode carrier can still bend in a direction away from the catheter shaft, bending (namely reverse folding) in a direction close to the catheter shaft is avoided, and the electrode assembly cannot form a preset working shape (such as a basket shape or a petal shape);

4) The setting piece can also control the maximum distance of the relative movement of the inner shaft of the catheter shaft and the outer tube, so as to control the final expanding shape of the electrode assembly;

5) By adding a blind circuit on the electrode carrier, the blind circuit is electrified in a normal state, and an electric loop is not formed because the blind circuit is electrically insulated from the transmission circuit; when the electrode carrier is cracked, the blind circuit is exposed to the external environment, blood can serve as a conductive medium, insulation between the blind circuit and a transmission circuit which needs to transmit energy is disabled, an electric loop is formed, and current is generated, and the current can be detected by a cracking detection module (such as a current sensor) to judge whether the electrode carrier is cracked or not.

Drawings

Those of ordinary skill in the art will appreciate that the figures are provided for a better understanding of the present invention and do not constitute any limitation on the scope of the present invention. Wherein:

FIG. 1 is a schematic view of an electrophysiology catheter according to an embodiment of the present invention in a contracted state;

FIG. 2 is a schematic view of an electrophysiology catheter according to an embodiment of the present invention in a basket state;

FIG. 3 is a schematic view of an electrophysiology catheter according to an embodiment of the present invention in a petal state;

FIG. 4 is an electrical schematic diagram illustrating ablation of an end electrode according to an embodiment of the present invention;

FIG. 5 is a schematic view of a stress diffuser according to an embodiment of the present invention in a natural state;

FIG. 6 is a schematic view of a stress diffuser according to an embodiment of the present invention in an active state;

FIG. 7 is a schematic view of a shaped member disposed at a distal end of a carrier according to an embodiment of the present invention;

FIG. 8 is a schematic view of a variable diameter setting member according to an embodiment of the present invention disposed at a proximal end of a carrier;

FIG. 9 is a schematic view of a variable diameter setting member according to an embodiment of the present invention disposed at a distal end of a carrier;

fig. 10 is a schematic diagram of a blind circuit arrangement according to an embodiment of the present invention;

FIG. 11 is a schematic view of an electrode carrier according to an embodiment of the present invention;

FIG. 12 is a schematic diagram of the connection of an end electrode to an electrode carrier according to an embodiment of the present invention;

FIG. 13 is a schematic diagram of an insulation layer according to an embodiment of the present invention;

FIG. 14 is a schematic diagram of a high voltage pulse ablation system according to an embodiment of the present invention;

fig. 15 is a schematic diagram of another high-voltage pulse ablation system according to an embodiment of the present invention.

Drawings

1-a catheter shaft; 2-end electrodes; a 3-electrode assembly; 4-stress diffuser; 5-shaping piece; 6-basket structure; 7-folding the piece;

10-an inner shaft; 11-an outer tube; 20-end electrode pads; 30-an electrode carrier; 31-electrode; 32-transmission lines; 33-blind line; 34-an insulating layer; 36-superelastic memory alloy;

310-inner electrode; 311-outer electrode; 312-electrode pads; 321-a first transmission line; 322-a second transmission line; 323-a third transmission line; 341-a first insulating layer; 342-a second insulating layer; 351-a first substrate; 352-a second substrate;

1001-an energy supply unit; 1002-a main control module; 1003-electrode combination switch; 1004-a user interface; 1005-electrophysiology catheter; 1006-a crack detection module.

Description of the embodiments

The invention provides an electrophysiological catheter and a high-voltage pulse ablation system, which are used for solving the problems that in the prior art, when a ring electrode is used for high-voltage pulse ablation, an electrode is attached to an unintended ablation part to form complications, and the joint of an electrode section and an end electrode is bent to form a smaller curvature radius, so that an electrode carrier is cracked due to stress concentration.

In a first aspect, the present invention provides an electrophysiology catheter comprising a catheter shaft and an electrode segment disposed at a distal section of the catheter shaft;

the main control module is used for sending a working instruction;

So configured, by having at least one of the electrodes participating in the paired electrical discharge on the side of the electrode carrier that is closest to the catheter shaft, when ablating the target tissue with the end electrode, the electrodes participating in the paired electrical discharge can be made to face away from or at least be difficult to contact non-target tissue, thereby preventing the electrodes participating in the paired electrical discharge from acting on non-target tissue to form an unintended ablation focus. In addition, by providing the stress dispersing member on at least one of the carrier proximal end and the carrier distal end, in the expanded state, the stress dispersing member can disperse stress acting on the at least one of the carrier proximal end and the carrier distal end, increase a bending radius of the electrode carrier corresponding to a position where the stress dispersing member is located, prevent stress concentration, and thereby avoid cracking of the electrode carrier.

The invention will be described in further detail with reference to the drawings and the specific embodiments thereof in order to make the objects, advantages and features of the invention more apparent. It should be noted that the drawings are in a very simplified form and are all to a non-precise scale, merely for the purpose of facilitating and clearly aiding in the description of embodiments of the invention. For a better understanding of the invention with objects, features and advantages, refer to the drawings. It should be understood that the structures, proportions, sizes, etc. shown in the drawings are shown only in connection with the present disclosure for the understanding and reading of the present disclosure, and are not intended to limit the scope of the invention, which is defined by the appended claims, and any structural modifications, proportional changes, or dimensional adjustments, which may be made by the present disclosure, should fall within the scope of the present disclosure under the same or similar circumstances as the effects and objectives attained by the present invention.

As used in this disclosure, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this disclosure, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. As used in this disclosure, the term "plurality" is generally employed in its sense including "at least one" unless the content clearly dictates otherwise. As used in this disclosure, the term "at least two" is generally employed in its sense including "two or more", unless the content clearly dictates otherwise. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first", "a second", "a third" may include one or at least two such features, either explicitly or implicitly.

In the description of the present invention, unless explicitly stated and limited otherwise, the terms "mounted," "connected," and "secured" are to be construed broadly, and may be, for example, fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communicated with the inside of two elements or the interaction relationship of the two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art.

Referring to fig. 1-3, in a first aspect, an embodiment of the present invention provides an electrophysiology catheter 1005 for ablating target tissue, including a catheter shaft 1 and an electrode section, wherein the electrode section is disposed at a distal end section of the catheter shaft 1;

the electrode segment comprising an end electrode 2 and an electrode assembly 3, the electrode assembly 3 being closer to the proximal end of the catheter shaft 1 than the end electrode 2;

the electrode assembly 3 comprises at least one electrode carrier 30 and a plurality of electrodes 31 positioned on the electrode carrier 30, when the end electrode 2 ablates the target tissue, the end electrode 2 is paired with at least one of the electrodes 31 for discharge, and at least one electrode 31 of the electrodes 31 participating in the paired discharge is positioned on the side of the electrode carrier 30 close to the catheter shaft 1.

When ablating the target tissue with the tip electrode 2, by positioning at least one electrode 31 of the electrodes 31 participating in the paired electrical discharges on the side of the electrode carrier 30 close to the catheter shaft 1, the electrodes 31 participating in the paired electrical discharges can face away from the non-target tissue or at least hardly contact the non-target tissue, thereby preventing the electrodes 31 participating in the paired electrical discharges from acting on the non-target tissue to form an unintended ablation focus. Preferably, all electrodes 31 participating in the paired discharge are located on the side of the electrode carrier 30 close to the catheter shaft 1.

It is to be understood that the definition of "proximal" and "distal" herein is: "proximal" generally refers to the end of the medical device that is closest to the operator during normal operation, and "distal" generally refers to the end of the medical device that first enters the patient during normal operation.

In this embodiment, the electrode carrier 30 of the electrode assembly 3 includes a carrier proximal end and a carrier distal end, which are relatively movable to switch the electrode carrier 30 of the electrode assembly 3 between a contracted state and an expanded state. As shown in fig. 1, in the contracted state, the electrode carrier 30 is folded toward the catheter shaft 1 to ensure that the catheter can safely reach the region of the target tissue; in the expanded state, at least a part of the electrode carrier 30 moves from a position retracted toward the catheter shaft 1 to a position away from the catheter shaft 1, and when the electrode carrier 30 is switched from the contracted state to the expanded state, the position of the electrode 31 on the electrode carrier 30 is also changed, and the technical idea of the present invention will be further explained by taking the two typical expanded states, i.e., the basket state (as shown in fig. 2) and the petal state (as shown in fig. 3), as examples.

In this embodiment, the catheter shaft 1 comprises an inner shaft 10 and an outer tube 11, the proximal end of the carrier being arranged on the outer tube 11, the distal end of the carrier being arranged on the inner shaft 10, the inner shaft 10 and the outer tube 11 being relatively movable for switching the electrode carrier 30 of the electrode assembly 3 between a contracted state and an expanded state.

Preferably, the outer tube 11 is sleeved on the inner shaft 10. Preferably, the inner shaft 10 and the outer shaft may be woven from polyurethane, pebax (polyether block polyamide), polyimide, or the like.

Preferably, the electrode carrier 30 where the at least one electrode 31 of the electrodes 31 participating in the paired discharge is located is a different electrode carrier 30 from the electrode carrier 30 where the end electrode 2 is electrically connected. Since the electrodes 31 involved in pairing need to transmit high-voltage pulses through the transmission lines, in order to reduce the insulation design requirement of the electrode carrier 30, the transmission lines of the electrodes 31 on the electrode carrier 30 where the end electrodes 2 are located and the transmission lines of the end electrodes 2 are prevented from forming high-voltage insulation breakdown, so that the end electrodes 2 and the electrodes 31 on different electrode carriers 30 can be paired and discharged.

Preferably, there are a plurality of electrode carriers 30 electrically connected to the end electrode 2 to disperse current, and reduce the line width of the electrode carrier 30 carrying the current of the end electrode 2. For cardiac ablation treatment, to reach the depth of an ablation range of 3-10mm, the line width of the corresponding end electrode 2 is 0.05-0.3 mm under the voltage of 500-2000V, and the line thickness is generally 20um copper line when the line width is considered.

More preferably, the electrode carriers 30 where the at least one electrode 31 of the electrodes 31 participating in the paired discharge is located and the electrode carriers 30 electrically connected to the end electrode 2 are alternately arranged in the circumferential direction of the catheter shaft 1 so as to design as many electrode carriers 30 electrically connected to the end electrode 2 as possible, improving the ablation effect. For example, as shown in fig. 4, the electrode carriers 30 are numbered clockwise when viewed from the axial direction of the catheter shaft 1, wherein the electrode carriers 30 electrically connected to the end electrodes 2 are numbered odd, and the electrode carriers 30 on which the electrodes 31 to be discharged in the pair with the end electrodes 2 are positioned are even. The "+" and "-" in fig. 4 represent different polarities, respectively.

Further, the electrode assembly 3 comprises a number of inner electrodes 310, the inner electrodes 310 being located on the side of the electrode carrier 30 close to the catheter shaft 1, the inner electrodes 310 comprising the at least one electrode 31 of the electrodes 31 participating in the paired discharge.

Still further, the inner electrode 310 has a position disposed toward the distal end of the catheter shaft 1.

In this embodiment, the inner electrode 310 has at least a first position and a second position;

In the first position, the electrode carrier 30, where the inner electrode 310 is located, is in a contracted state, and the electrode carrier 30 is folded towards the catheter shaft 1.

In the second position, the electrode carrier 30 is in an expanded state (basket state as shown in fig. 2), at least a portion of the electrode carrier 30 is moved from a position collapsed toward the catheter shaft 1 to a position remote from the catheter shaft 1, the inner electrode 310 being oriented toward the distal end of the catheter shaft 1.

It can be seen that when the end electrode 2 is paired with at least one of the inner electrodes 310 to ablate target tissue, the inner electrodes 310 will not act on non-target tissue to form an unintended ablation focus.

Further, the electrode assembly 3 further comprises a number of outer electrodes 311, said outer electrodes 311 being located on the side of the electrode carrier 30 facing away from the catheter shaft 1, said outer electrodes 311 being closer to the end electrode 2 than to the inner electrodes 310. That is, the inner electrode 310 and the outer electrode 311 are respectively located on both sides of the electrode carrier 30 opposite to each other, and the electrode 31 is divided into the inner electrode 310 and the outer electrode 311 in a manner to approach or depart from the catheter shaft 1.

Further, the inner electrode 310 has at least a third position, in which the electrode carrier 30 where the inner electrode 310 is located is in an expanded state (a petal state as shown in fig. 3), at least one of the inner electrodes 310 can be paired with at least one of the outer electrodes 311 for discharge, and at least a portion of the inner electrode 310 and at least a portion of the outer electrode 311 involved in the paired discharge act on and ablate the target tissue.

Preferably, the electrode carrier 30 is made of a flexible material, the electrode 31 may be made of platinum, gold, platinum iridium alloy, or the like, and preferably, the electrode 31 is a sheet electrode.

Referring to fig. 5-6, the electrophysiology catheter 1005 further includes at least one stress spreader 4, where the stress spreader 4 is disposed on at least one of the proximal end of the carrier and the distal end of the carrier, and in the expanded state, the stress spreader 4 can spread stress applied to the at least one of the proximal end of the carrier and the distal end of the carrier, increase a bending radius of the electrode carrier 30 corresponding to the location of the stress spreader 4, and prevent stress concentration, thereby avoiding cracking of the electrode carrier 30.

Further, the stress spreader 4 is sleeved on at least one of the proximal end of the carrier and the distal end of the carrier, and in the expanded state, at least a part of the stress spreader 4 is deformed by the at least one of the proximal end of the carrier and the distal end of the carrier. In this embodiment, the stress-spreader 4 has an initial configuration in which the stress-spreader 4 maintains its natural state, as shown in fig. 5, and an active configuration; in the active configuration, as shown in fig. 6, at least a portion of the stress-spreader 4 is deformed by the end section to spread the stress acting on the at least one of the proximal carrier end and the distal carrier end. For example, the stress diffuser 4 is provided at the distal end of the carrier, and when the electrode carrier 30 is switched from the contracted state to the expanded state, the stress diffuser 4 acts on the distal end of the carrier instead of the end electrode 2, enabling the portion of the electrode carrier 30 adjacent to the distal end of the carrier to be away from the catheter shaft 1.

Preferably, at least a portion of the stress-spreader 4 is more flexible than the end electrode 2.

Preferably, the stress dispersing member 4 is a ring member, and is sleeved on at least one of the proximal end of the carrier and the distal end of the carrier, and has a diameter equivalent to that of the end electrode 2, so as to ensure that the sheath passing is normal, the length of the stress dispersing member 4 is generally between 0.5mm and 5mm, and the thickness is between 0.1mm and 0.5mm, and the stress dispersing member can be made of elastic materials such as Pebax, polyurethane and the like. Preferably, the free end of the stress-spreader 4 is made of an elastic material, and can be fixed by adhesive bonding.

Referring to fig. 7, the electrophysiology catheter 1005 further includes a shaping member 5 disposed in the electrode assembly 3, the shaping member 5 is sleeved on the catheter shaft 1, and in a contracted state, the shaping member 5 acts on at least one of the proximal carrier end and the distal carrier end and makes the at least one of the proximal carrier end and the distal carrier end protrude outwards away from the catheter shaft 1.

When the electrode assembly 3 acts on a curved blood vessel, by sleeving the shaping member 5 on the catheter shaft 1 adjacent to the distal end of the carrier and/or the proximal end of the carrier, it is ensured that the electrode carrier 30 can still bend away from the catheter shaft 1, and bending (i.e., reverse folding) in a direction approaching the catheter shaft 1 is avoided, so that the electrode assembly 3 cannot form a predetermined working shape (such as a basket shape or a petal shape). In addition, by providing the shaping member 5, even in the case where the electrode carrier 30 is of a sheet-like flexible structure, it is ensured that a predetermined working pattern is formed at the portion of the bent blood vessel.

When the shaping member 5 is disposed adjacent the distal end of the carrier, the shaping member 5 may be disposed on the inner shaft 10 of the catheter shaft 1; when the shaping member 5 is disposed adjacent the proximal end of the carrier, the shaping member 5 may be disposed on the outer tube 11 of the catheter shaft 1 or alternatively may be disposed on the inner shaft 10 movably relative to the inner shaft 10. Preferably, in this embodiment, as shown in fig. 7, the shaping member 5 is disposed on the inner shaft 10 adjacent the distal end of the carrier.

Preferably, the maximum outer diameter of the shaping member 5 is larger than the outer diameter of the circle where the distal end of the carrier is located, so as to ensure that the distal end of the carrier protrudes outwards when the electrode assembly 3 is in the contracted state, and a trend of being away from the catheter shaft 1 is generated, thereby playing a role in shaping in advance. When the shaping piece 5 is arranged near the proximal end of the carrier, the maximum outer diameter of the shaping piece 5 is larger than the outer diameter of the circle where the proximal end of the carrier is located. More preferably, the maximum outer diameter of the shaping member 5 is smaller than the maximum outer diameter of the outer tube 11 and the maximum outer diameter of the gathering member 7 at the distal end of the carrier. Preferably, the gathering member 7 is the end electrode 2 or the stress spreader 4 or other means for gathering the distal end of the carrier. It is to be understood that in the present application, the gathering member 7 may be in the form of the end electrode 2 in the figures of fig. 1-3, 5-8, etc.

Further, at least one of the distal end and the proximal end of the shaping member 5 has a radial dimension not greater than the inner diameter of the circle where the end of the electrode carrier 30 is located, so as to prevent stress concentration caused by the end of the shaping member 5 pressing the end of the electrode carrier 30 when the electrode carrier 30 is switched from the contracted state to the expanded state, thereby causing bending and cracking of the electrode carrier 30. For example, when the shaping member 5 is disposed on the inner shaft 10 adjacent the distal end of the carrier, the proximal outer diameter of the shaping member 5 is smaller than the inner diameter of the circle in which the proximal end of the carrier is disposed, so that the proximal end of the shaping member 5 does not press the proximal end of the carrier when the electrode carrier 30 is switched from the contracted state to the expanded state, reducing the likelihood of buckling cracking thereof.

More preferably, at least a portion of the shaping member 5 near the distal end of the electrode 2 has a smaller outer diameter than the proximal end of the shaping member 5 away from the electrode 2, and the shaping member 5 is of a reduced diameter configuration, as shown in fig. 8, to better define the electrode carrier 30 in its intended operative configuration.

Preferably, the catheter shaft 1 comprises an inner shaft 10 and an outer tube 11, the inner shaft 10 and the outer tube 11 being relatively movable, the proximal carrier end being arranged on the outer tube 11, the distal carrier end being arranged on the inner shaft 10, the shaping member 5 being arranged on the inner shaft 10 adjacent to the distal carrier end, the shaping member 5 being adapted to control the maximum distance of relative movement of the inner shaft 10 and the outer tube 11 of the catheter shaft 1 and thereby the final configuration of the electrode assembly 3 expansion.

Further, when the shaping member 5 is disposed at the proximal end of the carrier, the proximal end of the carrier can be clamped by the shaping member 5 to the outer tube 11.

In this embodiment, the shaping member 5 may be made of an elastic material such as Pebax (polyether block polyamide) or polyurethane. Preferably, the shaping element 5 is adhesively secured to the inner shaft 10 or the outer tube 11.

Preferably, the distance between the shaping element 5 and the end electrode 2 is no more than 5mm. More preferably, the dimension of the shaping member 5 adjacent to the end electrode 2 is smaller than the outer diameter of the circle in which the distal end of the carrier is located, so as to reduce the movement of the shaping member 5.

Referring to fig. 10, at least one electrode carrier 30 of the electrode assembly 3 includes a transmission line 32 and a blind line 33, the transmission line 32 is electrically connected with the electrode 31 of the electrode assembly 3, and the blind line 33 is electrically connected with an energy supply unit and does not form an electrical circuit;

when the electrode assembly 3 is operating normally, the blind line 33 is not electrically connected to the transmission line 32; when the electrode carrier 30 breaks, the blind line 33 is electrically connected to the transmission line 32 and forms an electrical circuit with the power supply unit.

In a normal state, the blind wire 33 is energized, and an electric circuit is not formed because the blind wire 33 is electrically insulated from the transmission wire 32; when the electrode carrier 30 is broken, the blind circuit 33 is exposed to the external environment, blood may serve as a conductive medium, disabling insulation between the blind circuit 33 and the transmission circuit 32 to which energy is to be transferred, thereby forming an electrical circuit and generating a current which may be detected by a broken detection module (e.g., a current sensor) and thus determining whether the electrode carrier 30 is broken.

Preferably, the blind circuit 33 and the transmission circuit 32 are layered and layered.

Preferably, the blind line 33 extends along the extending direction of the electrode carrier 30 at least from the carrier proximal end of the electrode carrier 30 to the maximum bend of the carrier distal end of the electrode carrier 30 in the expanded state, considering that the maximum bend of the carrier distal end of the electrode carrier 30 in the expanded state is more likely to occur.

Preferably, the blind circuit 33 is disposed closer to the outer side of the electrode carrier 30 than the transmission circuit 32, so as to timely detect the cracking condition of the electrode carrier 30, and ensure the safety of treatment.

Alternatively, the electrode section may be provided with one blind line 33, or a plurality of blind lines 33 insulated from each other, which is not limited in this application.

In this embodiment, the electrode carrier 30 further includes an insulating layer 34 and a substrate, the transmission line 32 is disposed on the insulating layer 34, the substrate covers the transmission line 32, and the electrode 31 is disposed on the other side of the substrate with respect to the transmission line 32 and is electrically connected to the transmission line 32.

Preferably, the other side of the substrate is provided with an electrode pad 312, and the electrode 31 is electrically connected to the transmission line 32 through the pad 312.

Referring to fig. 11, in the present embodiment, the transmission line 32 includes a first transmission line 321 electrically connected to the inner electrode 310, and a second transmission line 322 electrically connected to the outer electrode 311, the substrates include a first substrate 351 and a second substrate 352, the first transmission line 321 and the second transmission line 322 are respectively disposed on opposite sides of the insulating layer 34, the first substrate 351 and the second substrate 352 respectively cover the first transmission line 321 and the second transmission line 322, and the insulating layer 34 is used for isolating the first transmission line 321 and the second transmission line 322.

With continued reference to fig. 11, the transmission line 32 further includes a third transmission line 323 connected to the end electrode 2, and the third transmission line 323 is electrically connected to the end electrode 2 through an end electrode pad 20 provided on the substrate.

Referring to fig. 12, the end electrode pad 20 is electrically connected to the end electrode 2 through a wire, and the end electrode 2 may be filled with glue to ensure the connection stability between the electrode carrier 30 and the end electrode 2, so as to provide a buffer space when the electrode carrier 30 is switched to an expanded state, thereby preventing the connection between the end electrode 2 and the electrode carrier 30 from being accidentally released.

Optionally, the third transmission line 323 may be disposed on the first transmission line layer, or may be disposed on the second transmission line layer, or may be disposed independently of the first transmission line layer, which is not limited in this application.

In this embodiment, the material of the insulating layer 34 includes, but is not limited to, polyimide, PDMS (polydimethylsiloxane) or LCP (industrialized liquid crystal polymer).

Preferably, referring to fig. 13, the insulating layer 34 is a composite insulating layer, and includes a first insulating layer 341 and a second insulating layer 342, and a superelastic memory alloy 36, such as a nickel-titanium alloy, is disposed between the first insulating layer 341 and the second insulating layer 342 to improve the shape-retaining capability of the electrode carrier 30.

In this embodiment, an insulating glue is filled between the insulating layer and the base layer, so as to be used for bonding between layers and insulating a transmission line.

Preferably, a superelastic memory alloy 36 is provided in at least one electrode carrier 30 of the electrode assembly 3 to improve its shape retention capability.

Referring to fig. 14 in combination with fig. 1-4 and 11, the present invention provides a high voltage pulse ablation system, which comprises an energy supply unit 1001, a main control module 1002, an electrode combination switch 1003, a user interface 1004 and an electrophysiology catheter 1005 as described above;

The main control module 1002 is configured to send a working instruction;

the energy supply unit 1001 is in communication connection with the main control module 1002 and is used for delivering high-voltage pulses to the electrode section of the electrophysiology catheter 1005 according to the working instruction;

the electrode combination switch 1003 is in communication connection with the main control module 1002, and is configured to select a transmission line 32 of an electrode carrier 30 of the electrode assembly that needs to transmit energy according to the working instruction, so as to implement paired discharge of the electrode segments;

the user interface 1004 is in communication connection with the main control module 1002, and is configured to perform man-machine interaction, so as to control and display information of the high-voltage pulse ablation system.

Further, the high-pressure pulse ablation system includes at least one of the following modes of operation:

in a first mode of operation, ablation is performed through the end electrode 2;

in a second mode of operation, the electrode segments are in an expanded state, ablation being performed by the end electrode 2 and/or the outer electrode 311 of the electrode assembly 3;

in a third mode of operation, the electrode segments are in an expanded state, and ablation is performed by the inner electrode 310 of the electrode assembly 3 and/or the outer electrode 311 of the electrode assembly 3.

Wherein, ablation by the end electrode 2 and the inner electrode 310 of the electrode assembly 3 is the most important operation mode in the high-voltage pulse ablation system provided in this embodiment.

In this embodiment, in the first operation mode, the electrode segment is in a contracted state, ablation is performed by the end electrode 2, and in this state, the end electrode 2 and the inner electrode 310 of the electrode assembly 3 are paired for discharge.

In this embodiment, in the second operation mode, the electrode segment is in a basket state and can be ablated by the end electrode 2 and/or the outer electrode 311 of the electrode assembly 3; when ablation is performed by the end electrode 2, the end electrode 2 performs a paired discharge with the inner electrode 310 of the electrode assembly 3; when ablation is performed by the outer electrode 311 of the electrode assembly 3, the outer electrode 311 and the inner electrode 310 perform a pairing discharge.

In this embodiment, in the third operation mode, the electrode segments are in a petal state, and ablation is performed by the inner electrode 310 of the electrode assembly 3 and/or the outer electrode 311 of the electrode assembly 3, and in this state, the outer electrode 311 and the inner electrode 310 are paired for discharge.

Preferably, the main control module 1002 is capable of selectively controlling the end electrode 2, the outer electrode 311, and the inner electrode 310.

Further, the power supply unit 1001 is further configured to energize the blind lines 33 and the transmission lines 32 that need to be discharged, so that the polarity of the blind lines 33 is opposite to the polarity of at least one of the transmission lines 32;

referring to fig. 15 in combination with fig. 10, the ablation system further includes a crack detection module 1006 communicatively connected to the main control module 1002, where the crack detection module 1006 is configured to detect whether the blind line 33 and the transmission line 32 are conductive, and if so, send a crack signal to the main control module 1002.

In a normal state, since the blind wire 33 is electrically insulated from the external environment, the blind wire 33 does not form an electrical circuit with the transmission wire 32, and the crack detection module 1006 does not detect a current generated between the normally discharged transmission wire 32 and the blind wire 33. When the electrode carrier 30 is broken, the blind circuit 33 is exposed to the external environment, blood can be used as a conductive medium, so that insulation between the blind circuit 33 and the discharged transmission circuit 32 is disabled, an electric loop is formed, and a current is generated, the breaking detection module 1006 can detect the current and send a breaking signal to the main control module 1002, and the main control module 1002 interrupts the discharge of the high-voltage pulse electric field generator according to the breaking signal to end the treatment, or provides an alarm (such as an alarm) to improve the system safety.

Preferably, the transmission line 32 of the discharge is a transmission line 32 adjacent to the blind line 33.

In this embodiment, the power supply unit 1001 includes a high voltage pulse electric field generator capable of delivering a high voltage pulse to the blind circuit 33.

Preferably, the power supply unit 1001 further includes a low voltage generator, and in a non-discharging state, the electrode combination switch 1003 may be switched to be conductive to the low voltage generator, and may be used to power the blind circuit 33 instead of the high voltage pulse electric field generator, and two poles of the low voltage generator are electrically connected to the blind circuit 33 and at least one of the transmission circuits 32, respectively. Since the low voltage generator continuously releases a low voltage signal, the current can be detected in real time by the crack detection module 1006. By supplying an electrical signal to the blind circuit 33 via the low voltage generator, the insulation design of the electrode carrier 30 can be reduced while ensuring therapeutic safety.

On the other hand, referring to fig. 2, 5 and 6, an embodiment of the present invention provides a catheter for treating a target tissue, which includes a catheter shaft 1 and a basket structure 6, wherein the basket structure 6 is disposed at a distal end section of the catheter shaft 1 and has a contracted state and an expanded state, and in the contracted state, the basket structure 6 is folded toward the catheter shaft 1 so as to ensure that the catheter can safely reach a region where the target tissue is located; in the expanded state, at least a portion of the basket structure 6 is moved from a position collapsed toward the catheter shaft 1 to a position remote from the catheter shaft 1;

The basket structure 6 includes a basket proximal end and a basket distal end that are relatively movable to switch the basket structure 6 between the contracted state and the expanded state;

at least one stress spreader 4 is disposed on at least one of the proximal end and the distal end of the basket, and in the expanded state, the stress spreader 4 can spread stress applied to the at least one of the proximal end and the distal end of the basket, and increase a bending radius of the basket structure 6 corresponding to the position of the stress spreader 4, thereby preventing stress concentration, avoiding cracking of the basket structure 6 and preventing the proximal end and the distal end of the basket from failing to return to their contracted state under excessive stress.

In this embodiment, the basket structure 6 includes, but is not limited to, the electrode assembly 3 of the previous embodiment. Including but not limited to the electrophysiology catheter 1005 of the previous embodiment. It is to be understood that in the present application, the basket structure 6 may be in the form of the electrode assembly 3 in fig. 1-3.

Further, the stress dispersing member 4 is sleeved on at least one of the proximal end of the basket and the distal end of the basket, and in the expanded state, at least a portion of the stress dispersing member 4 is deformed by the at least one of the proximal end of the basket and the distal end of the basket. In this embodiment, the stress-spreader 4 has an initial configuration in which the stress-spreader 4 maintains its natural state and an active configuration; in the active configuration, at least a portion of the stress diffuser 4 deforms under the action of the end section, dispersing the stress acting on the at least one of the basket proximal end and the basket distal end.

Preferably, the stress dispersing member 4 is an annular member and is sleeved on at least one of the proximal end and the distal end of the basket, the length of the stress dispersing member 4 is generally between 0.5mm and 5mm, and the thickness is between 0.1mm and 0.5mm, and the stress dispersing member can be made of elastic materials such as Pebax, polyurethane and the like. Preferably, the free end of the stress-spreader 4 is made of an elastic material, and can be fixed by adhesive bonding.

Further, referring to fig. 7, the catheter further comprises a shaping member 5 disposed within the basket structure 6, the shaping member 5 being disposed over the catheter shaft 1, the shaping member 5 acting on at least one of the proximal basket end and the distal basket end in a contracted state and causing the at least one of the proximal basket end and the distal basket end to bulge outwardly away from the catheter shaft 1. When the catheter acts on a curved vessel, by sleeving the shaping member 5 on the catheter shaft 1 adjacent to the distal end and/or the proximal end of the basket, it is ensured that the basket structure 6 can still bend away from the catheter shaft 1, avoiding bending (i.e. reverse folding) in a direction towards the catheter shaft 1, so that the basket structure 6 cannot form a predetermined working configuration. In addition, by arranging the shaping member 5, when the basket structure 6 is a sheet-like flexible structure, it is ensured that a predetermined working form is formed at a portion of the bent blood vessel.

Still further, the catheter shaft 1 comprises an inner shaft 10 and an outer tube 11, the inner shaft 10 and the outer tube 11 being relatively movable, the proximal basket end being arranged on the outer tube 11 and the distal basket end being arranged on the inner shaft 10. When the shaping member 5 is disposed adjacent the distal end of the basket, the shaping member 5 may be disposed on the inner shaft 10 of the catheter shaft 1; when the shaping member 5 is disposed adjacent the proximal end of the basket, the shaping member 5 can be disposed on the outer tube 11 of the catheter shaft 1 or alternatively can be disposed on the inner shaft 10 movably relative to the inner shaft 10.

Preferably, the shaping member 5 is disposed on the inner shaft 10 adjacent the basket distal end, and the shaping member 5 controls the maximum distance that the inner shaft 10 of the catheter shaft 1 and the outer tube 11 can move relative to each other, thereby controlling the final configuration of the expansion of the basket structure 6.

Preferably, the maximum outer diameter of the shaping member 5 is greater than the outer diameter of the circle where the distal end of the basket is located, so as to ensure that the distal end of the basket protrudes outwards when the basket structure 6 is in the contracted state, and a trend of being far away from the catheter shaft 1 is generated, thereby playing a role in shaping in advance. When the shaping piece 5 is arranged close to the proximal end of the basket, the maximum outer diameter of the shaping piece 5 is larger than the outer diameter of the circle where the proximal end of the basket is located. More preferably, the maximum outer diameter of the shaping member 5 is smaller than the maximum outer diameter of one of the maximum outer diameter of the outer tube 11 and the maximum outer diameter of the gathering member 7 at the distal end of the basket.

Further, the radial dimension of at least one of the distal end and the proximal end of the shaping member 5 is not greater than the inner diameter of the circle where the end of the basket structure 6 is located, so as to prevent the end of the shaping member 5 from pressing the end of the basket structure 6 to cause stress concentration when the basket structure 6 is switched from the contracted state to the expanded state, thereby causing the bending and cracking of the basket structure 6. For example, when the shaping member 5 is disposed on the inner shaft 10 adjacent the basket distal end, the proximal outer diameter of the shaping member 5 is less than the inner diameter of the circle in which the basket proximal end is disposed, such that when the basket structure 6 is switched from the contracted state to the expanded state, the proximal end of the shaping member 5 does not squeeze the basket proximal end, reducing the likelihood of buckling cracking thereof.

Preferably, as shown in fig. 8, at least a portion of the shaping member 5 has a smaller distal outer diameter near the distal end of the catheter shaft 1 than the proximal outer diameter of the shaping member 5 near the proximal end of the catheter shaft 1, i.e. the shaping member 5 may be designed in a reducing configuration to better shape the basket structure 6 into a predetermined working configuration.

The shaping member 5 may be made of an elastic material such as Pebax (polyether block polyamide), polyurethane, etc., and the shaping member 5 is adhesively fixed to the inner shaft 10 or the outer tube 11.

Preferably, the length of the shaping piece 5 is between 1mm and 5mm.

Preferably, the distance between the shaping piece 5 and a furling piece 7 arranged on the catheter shaft 1 for furling the distal end of the basket is not more than 5mm. Preferably, the gathering member 7 is the end electrode 2 or the stress spreader 4 or other member that gathers the distal end of the basket.

Preferably, the basket structure 6 includes a superelastic memory alloy 36 to enhance the shape retention capability of the basket structure 6.

On the other hand, referring to fig. 2 and 7, the embodiment of the present invention provides a catheter for treating a target tissue, which includes a catheter shaft 1 and a basket structure 6, wherein the basket structure 6 is disposed at a distal end section of the catheter shaft 1 and has a contracted state and an expanded state, and in the contracted state, the basket structure 6 is folded toward the catheter shaft 1 so as to ensure that the catheter can safely reach an area where the target tissue is located; in the expanded state, at least a portion of the basket structure 6 is moved from a position collapsed toward the catheter shaft 1 to a position remote from the catheter shaft 1;

The catheter further comprises a shaping member 5 arranged in the basket structure 6, the shaping member 5 is sleeved on the catheter shaft 1, and in the contracted state, the shaping member 5 acts on at least one of the proximal basket end and the distal basket end and enables the at least one of the proximal basket end and the distal basket end to protrude outwards away from the catheter shaft 1.

In this embodiment, the basket structure 6 includes, but is not limited to, the electrode assembly 3 of the previous embodiment. Including but not limited to the electrophysiology catheter 1005 of the previous embodiment.

On the other hand, referring to fig. 2 and 10, an embodiment of the present invention provides an electrode carrier that can be disposed at a distal end section of a catheter, and includes a transmission line 32 and a blind line 33, the transmission line 32 being electrically connected to an electrode 31, the blind line 33 being electrically connected to an energy supply unit and not forming an electrical circuit;

when the electrode carrier 30 is operating normally, the blind line 33 is not electrically connected to the transmission line 32; when the electrode carrier 30 breaks, the blind line 33 is electrically connected to the transmission line 32 and forms an electrical circuit with the power supply unit.

In a normal state, the blind wire 33 is energized, and an electric circuit is not formed because the blind wire 33 is electrically insulated from the transmission wire 32; when the electrode carrier 30 is broken, the blind circuit 33 is exposed to the external environment, blood may serve as a conductive medium, disabling insulation between the blind circuit 33 and the transmission circuit 32 to which energy is to be transferred, thereby forming an electrical circuit and generating a current which may be detected by a broken detection module (e.g., a current sensor) and thus determining whether the electrode carrier 30 is broken. The crack can be detected by an impedance value detection method, and the impedance value is detected by using high-frequency low-voltage (1 KHz-100 kHz, below 5V).

In this embodiment, the catheter includes, but is not limited to, the electrophysiology catheter 1005 in the previous embodiment.

In another aspect, referring to FIGS. 1-4, an embodiment of the present invention provides an electrophysiology catheter 1005 for ablating target tissue, comprising a catheter shaft 1 and an electrode assembly 3, the electrode assembly 3 being disposed at a distal section of the catheter shaft 1;

the electrode assembly 3 comprises an electrode carrier 30 as described above and the electrode 31 on the electrode carrier 30.

Further, the electrode 31 comprises an inner electrode 310 and an outer electrode 311, the inner electrode 310 being located on the side of the electrode carrier 30 closest to the catheter shaft 1, the outer electrode 311 being located on the side of the electrode carrier 30 facing away from the catheter shaft 1, the outer electrode 311 being located closer to the distal end of the catheter shaft 1 than the inner electrode 310.

In another aspect, with reference to fig. 10 and 15, an embodiment of the present invention provides a high voltage pulse ablation system, comprising an energy supply unit 1001, a main control module 1002, an electrode combination switch 1003, a user interface 1004, and an electrophysiology catheter 1005 as described above;

the main control module 1002 is configured to send a working instruction;

The energy supply unit 1001 is in communication connection with the main control module 1002, and is configured to deliver a high-voltage pulse to the electrode assembly 3 according to the operation command;

the electrode combination switch 1003 is communicatively connected to the main control module 1002, and is configured to select the transmission line 32 that needs to transmit energy according to the working instruction, so as to implement paired discharge of the electrode assembly 3;

the user interface 1004 is in communication connection with the main control module 1002, and is configured to perform man-machine interaction, so as to control and display information of the high-voltage pulse ablation system;

the power supply unit 1001 is further configured to energize the blind lines 33 and the transmission lines 32 that need to be discharged, so that the polarity of the blind lines 33 is opposite to the polarity of at least one of the transmission lines 32;

the ablation system further comprises a crack detection module 1006 in communication with the main control module 1002, wherein the crack detection module 1006 is configured to detect whether the blind line 33 is conducted with the transmission line 32, and if so, send a crack signal to the main control module 1002.

The above description is only illustrative of the preferred embodiments of the present invention and is not intended to limit the scope of the present invention, and any alterations and modifications made by those skilled in the art based on the above disclosure shall fall within the scope of the present invention. It will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the spirit or scope of the invention. Thus, the present invention is intended to include such modifications and alterations insofar as they come within the scope of the invention or the equivalents thereof.

Claims

1. An electrophysiology catheter for ablating target tissue, comprising a catheter shaft and an electrode segment disposed at a distal end segment of the catheter shaft;

the electrode assembly comprises at least one electrode carrier and a plurality of electrodes positioned on the electrode carrier, when the end electrode ablates the target tissue, the end electrode is paired with at least one electrode for discharge, and at least one electrode of the electrodes participating in paired discharge is positioned on the side surface of the electrode carrier close to the catheter shaft;

the electrode carrier where the at least one electrode is positioned in the electrodes participating in the paired discharge is different from the electrode carrier where the end electrode is electrically connected;

the electrode carriers where the at least one electrode among the electrodes participating in the paired discharge is located and the electrode carriers where the end electrodes are electrically connected are alternately arranged in the circumferential direction of the catheter shaft.

2. The electrophysiology catheter according to claim 1, wherein the electrode assembly comprises several inner electrodes on the side of the electrode carrier close to the catheter shaft, the inner electrodes comprising the at least one of the electrodes participating in the paired electrical discharge.

3. The electrophysiology catheter according to claim 2, wherein the inner electrode has a position disposed toward a distal end of the catheter shaft.

4. The electrophysiology catheter according to claim 2, wherein the inner electrode has at least a first position and a second position;

5. The electrophysiology catheter according to any one of claims 2, 3, 4, wherein the electrode assembly further comprises a number of outer electrodes on the side of the electrode carrier facing away from the catheter shaft, the outer electrodes being closer to the end electrode than the inner electrodes.

6. The electrophysiology catheter according to claim 5, wherein the inner electrode has at least a third position in which the electrode carrier on which the inner electrode is positioned is in an expanded state, and at least a portion of the inner electrode and at least a portion of the outer electrode act on and ablate the target tissue.

7. The electrophysiology catheter according to any one of claims 1-3, 4, 6, wherein the electrode carrier of the electrode assembly comprises a carrier proximal end and a carrier distal end, the carrier proximal end and the carrier distal end being relatively movable to switch the electrode carrier of the electrode assembly between a contracted state and an expanded state.

8. The electrophysiology catheter according to claim 7, further comprising at least one stress diffuser disposed on at least one of the carrier proximal end and the carrier distal end, the stress diffuser being capable of distributing stress acting on the at least one of the carrier proximal end and the carrier distal end in the expanded state.

9. The electrophysiology catheter of claim 8 wherein the stress diffuser is positioned over at least one of the proximal carrier end and the distal carrier end, wherein in the expanded state at least a portion of the stress diffuser is deformed by the at least one of the proximal carrier end and the distal carrier end.

10. The electrophysiology catheter according to claim 7, further comprising a sizing member disposed within the electrode assembly, the sizing member being disposed over the catheter shaft, the sizing member acting on at least one of the proximal carrier end and the distal carrier end in a contracted state and protruding the at least one of the proximal carrier end and the distal carrier end outwardly away from the catheter shaft.

11. The electrophysiology catheter according to claim 10, wherein the catheter shaft comprises an inner shaft and an outer tube, the inner shaft and the outer tube being relatively movable, the carrier proximal end being disposed on the outer tube, the carrier distal end being disposed on the inner shaft;

12. The electrophysiology catheter according to claim 10, wherein the shaping member is of a variable diameter configuration so that the electrode carrier is formed into a predetermined working configuration.

13. The electrophysiology catheter of claim 10 wherein at least one of the distal end and the proximal end of the sizing member has a radial dimension that is no greater than an inner diameter of a circle in which the end of the electrode carrier is located.

14. The electrophysiology catheter according to any one of the claims 10-13, wherein the shaping member has a length of between 1mm-5 mm.

15. The electrophysiology catheter according to any one of claims 10-13, wherein the sizing member is spaced apart from a tucking member provided on the catheter shaft for tucking the distal end of the carrier by no more than 5mm.

16. The electrophysiology catheter according to any one of claims 1-3, 4, 6, 8-13, wherein the at least one electrode carrier of the electrode assembly comprises a transmission line and a blind line, the transmission line being electrically connected with the electrode of the electrode assembly, the blind line being electrically connected with the power supply unit and not forming an electrical circuit;

17. The electrophysiology catheter according to claim 16, wherein the electrode carrier further comprises an insulating layer and a substrate, the transmission line is provided on the insulating layer, the substrate covers the transmission line, and the electrode is provided on the other side of the substrate with respect to the transmission line and is electrically connected to the transmission line.

18. The electrophysiology catheter according to claim 16, wherein the blind line extends along the extension direction of the electrode carrier at least from the carrier proximal end of the electrode carrier to a maximum bend of the carrier distal end of the electrode carrier in the expanded state.

19. The electrophysiology catheter according to claim 16, wherein the blind wire is arranged closer to the outer side of the electrode carrier than the transmission wire.

20. The electrophysiology catheter according to any one of claims 1-3, 4, 6, 8-13, 17-19, wherein there are a plurality of electrode carriers electrically connected to the tip electrode.

21. The electrophysiology catheter according to any one of claims 1-3, 4, 6, 8-13, 17-19, wherein a superelastic memory alloy is provided in at least one electrode carrier of the electrode assembly to improve its shape retention capacity.

22. A high voltage pulse ablation system comprising an energy supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiology catheter according to any one of claims 1-21;

the main control module is used for sending a working instruction;

23. The high pressure pulse ablation system of claim 22, wherein the high pressure pulse ablation system comprises at least one of the following modes of operation:

In a first mode of operation, ablation is performed through the tip electrode;

in a third mode of operation, the electrode segments are in an expanded state, and ablation is performed through the inner electrode of the electrode assembly and the outer electrode of the electrode assembly.

24. The high voltage pulse ablation system of claim 23, wherein the main control module is capable of selectively controlling the end electrode, the outer electrode, and the inner electrode.

25. A high voltage pulse ablation system comprising an energy supply unit, a main control module, an electrode combination switch, a user interface, and an electrophysiology catheter according to any one of claims 16-19;

the main control module is used for sending a working instruction;

26. The high voltage pulse ablation system of claim 25, wherein the energy supply unit delivers high voltage pulses to the blind circuit.

27. The high voltage pulse ablation system of claim 25, wherein the power supply unit further comprises a low voltage generator, the electrode combination switch being switchable to be in electrical communication with the low voltage generator in a non-discharge state, the low voltage generator having two poles electrically connected to the blind circuit and at least one of the transmission lines, respectively.