CN115813526A

CN115813526A - Electrophysiology catheter and high-voltage pulse ablation system

Info

Publication number: CN115813526A
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: 2023-03-21
Anticipated expiration: 2043-02-17
Also published as: CN116407261A; CN115813526B; 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 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 relative to the end electrode; the electrode assembly includes at least one electrode carrier and a plurality of electrodes on the electrode carrier, the tip electrode is paired with at least one of the electrodes for discharging when the tip electrode ablates the target tissue, and at least one of the electrodes involved in the paired discharge is located on a side of the electrode carrier near the catheter shaft. When the target tissue is ablated by the end electrode, the invention can lead the electrode participating in the pairing to be back to the non-target tissue or at least to be difficult to contact with the non-target tissue, thereby preventing the electrode participating in the pairing from acting on the non-target tissue to form an unintended 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 clinical arrhythmias. Pulsed electric field ablation, a relatively new method of atrial fibrillation ablation, is delivered to the myocardial tissue by a catheter-electrode pulsed electric field. The pulsed electric field may cause irreversible electroporation of cell production to increase the permeability of the cells, resulting in cell death to form foci. Compared with the traditional radio frequency ablation and cryoablation, the pulsed electric field ablation technology is a non-thermal effect ablation technology, and the pulsed electric field ablation technology has better safety in the field of atrial fibrillation treatment due to the characteristic of cell selectivity.

The pulse electric field ablation operation is characterized in that after a catheter head end (far end) is inserted into a human body to reach a corresponding treatment target position through a blood vessel interventional operation, an energy platform connected with a catheter tail end (near end) is used for sending energy media (such as radio frequency, ultrasonic, pulse and other energy), an energy delivery electrode is arranged at the far end of the catheter, and the energy is transferred to tissues after the electrode is attached to the tissues, so that tissue ablation is carried out.

The structure of the catheter mainly comprises a polymer pipe material and an electrode assembly of a ring electrode, a certain number of electrode assemblies are circumferentially arranged on the catheter shaft to form an electrode section, and the electrode section is switched among a contraction state, a basket state and a petal state through the relative movement of the catheter shaft, so that the purpose of adapting to different vascular anatomical structures is achieved, and the treatment is better carried out. Meanwhile, in order to make up the problem that the electrode section cannot meet the treatment requirement of small-area ablation, an end electrode is arranged at the far end of the electrode section, the ablation mode of the end electrode comprises a unipolar mode and a multipolar mode, the unipolar mode is used for treating by forming energy transmission between the end electrode at 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 a ring electrode of the electrode section. In actual atrial fibrillation, when the end electrode is placed against the intended site in the multi-polar mode, the ring electrode is usually suspended in blood, but may be placed against the unintended ablation site with a certain probability. When a pulse voltage is applied, high-intensity electric fields are formed at the end electrode and the annular electrode, so that the non-predetermined ablation part close to the annular electrode is ablated with a certain probability to form complications.

In addition to the catheter electrode segment structure with polymer matched with the ring electrode, the electrode segment composed of the flexible circuit board as the electrode carrier is also used in the catheter structure design for atrial fibrillation treatment. The flexible circuit board is influenced by the manufacturing technology, and the torsion resistance and the bending resistance of the material are poor. When the flexible circuit board is used as an electrode section carrier, the form change is limited, and particularly when the electrode section is changed into a petal form, the joint of the electrode section 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 present invention is directed to an electrophysiology catheter and a high voltage pulse ablation system, which at least solve one of the problems of the prior art or the related art.

To achieve the above object, 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 electrode segment comprising an end electrode and an electrode assembly, the electrode assembly being closer to the proximal end of the catheter shaft relative to the end electrode;

the electrode assembly includes at least one electrode carrier and a plurality of electrodes on the electrode carrier, the tip electrode is paired with at least one of the electrodes to discharge when the tip electrode ablates the target tissue, and at least one of the electrodes involved in the paired discharge is located on a side of the electrode carrier near the catheter shaft.

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

Optionally, the inner electrode has a position disposed toward the 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 is different from the electrode carrier electrically connected to the end electrode.

Optionally, electrode carriers on which the at least one of the electrodes participating in the mating discharge is electrically connected to the tip electrodes 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, the electrode carrier with the inner electrode 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 moving from a collapsed position toward the catheter shaft to a position away from the catheter shaft, the inner electrode being toward the distal end of the catheter shaft.

Optionally, the electrode assembly further comprises a plurality 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 the third position, the electrode carrier where the inner electrode is located is in an expanded state, and at least a part of the inner electrode and at least a part of the outer electrode act on the target tissue and ablate the target tissue.

Optionally, 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.

Optionally, the electrophysiology catheter further comprises at least one stress spreader disposed on at least one of the carrier proximal end and the carrier distal end, the stress spreader being capable of spreading stress applied to the at least one of the carrier proximal end and the carrier distal end in the expanded state.

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

Optionally, the electrophysiology catheter further comprises a sizing disposed within the electrode assembly, the sizing being sleeved on the catheter shaft, the sizing acting on at least one of the carrier proximal end and the carrier distal end in a collapsed state and causing the at least one of the carrier proximal end and the carrier distal end to bulge outwardly away from the catheter shaft.

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

the sizer is disposed over the inner shaft adjacent the carrier distal end.

Optionally, the shape-fixing piece is of a reducing structure, so that the electrode carrier forms a preset working shape.

Optionally, at least one of the distal end and the proximal end of the former has a radial dimension no greater than the inner diameter of the circle in which the ends of the electrode carrier lie.

Optionally, the length of the fixed part is between 1mm and 5mm.

Optionally, the spacing between the shape-fixing member and a gathering member provided on the catheter shaft for gathering the distal end of the carrier is not more than 5mm.

Optionally, at least one electrode carrier of the electrode assembly comprises a transmission line electrically connected with an electrode of the electrode assembly and a blind line electrically connected with an energy supply unit and not forming an electrical circuit;

when the electrode assembly normally operates, the blind circuit and the transmission line are not electrically conducted; when the electrode carrier is cracked, the blind circuit is electrically conducted with the transmission line and forms an electric 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 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 arranged closer to the outer side 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 improve its form retention.

In a second aspect, the 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 the electrophysiology 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 transmitting high-voltage pulses to the electrode section of the electrophysiological 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 energy transmission according to the working instruction so as to realize pairing discharge of the electrode sections;

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

Optionally, the high voltage pulse ablation system comprises at least one of the following operating modes:

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

in a second mode of operation, the electrode segments are in an expanded state and ablation is 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 by an inner electrode of the electrode assembly and/or an outer electrode of the electrode assembly.

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

In a third aspect, the 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 the electrophysiology 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 needing energy transmission according to the working instruction so as to realize 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 realize control and information display of the high-voltage pulse ablation system;

the power supply unit is also used for electrifying the blind line and the transmission line needing to be discharged, so that the polarity of the blind line is opposite to that 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 line is communicated with the transmission line, and if the blind line is communicated with the transmission line, a cracking signal is sent to the main control module.

Optionally, the energy supply unit supplies high voltage pulses to the blind line.

Optionally, the energy supply unit still includes low voltage generator, under the non-discharge state, electrode combination switch can switch over to with low voltage generator switches on, low voltage generator's the two poles of the earth respectively with blind circuit and at least one transmission line electricity is connected.

In a fourth aspect, the present invention provides a catheter for treating a target tissue, comprising a catheter shaft and a basket structure, the basket structure being disposed at a distal section of the catheter shaft and having a collapsed state in which the basket structure is collapsed towards the catheter shaft to ensure that the catheter can safely reach an area where the target tissue is located 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 away from the catheter shaft;

the basket structure comprises a basket proximal end and a basket distal end that are relatively movable to switch the basket structure between the collapsed state and the expanded state;

at least one stress spreader disposed on at least one of the basket proximal end and basket distal end, the stress spreader being capable of spreading stress applied to the at least one of the basket proximal end and basket distal end in the expanded state.

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

Optionally, the catheter further comprises a shape-fixing member disposed in the basket structure, the shape-fixing member being sleeved on the catheter shaft, and in a contracted state, the shape-fixing member acts on at least one of the basket proximal end and the basket distal end and protrudes the at least one of the basket proximal end and the basket distal end outward away from the catheter shaft.

Optionally, the catheter shaft comprises an inner shaft and an outer tube, the inner and outer tubes being relatively movable, the basket proximal end being disposed on the outer tube and the basket distal end being disposed on the inner shaft; the profile is disposed on the inner shaft adjacent a distal end of the basket.

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

Optionally, the length of the fixed part is between 1mm and 5mm.

Optionally, the spacing between the shape fixing element and a furling element arranged on the catheter shaft for furling the far end of the net basket is not more than 5mm.

Optionally, the basket structure comprises a superelastic memory alloy to improve the form-retaining ability 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 and having a collapsed state in which the basket structure is collapsed towards the catheter shaft to ensure that the catheter can safely reach the area 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 away from the catheter shaft;

the catheter also comprises a shaping piece arranged in the net 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 net basket proximal end and the net basket distal end and enables the at least one of the net basket proximal end and the net basket distal end to protrude outwards 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 basket proximal end being disposed on the outer tube and the basket distal end being disposed on the inner tube;

the shape-fixing member is arranged on the inner pipe adjacent to the far end of the net basket.

Optionally, the length of the fixed part is between 1mm and 5mm.

In a sixth aspect, the present invention provides an electrode carrier, which is capable of being arranged at a distal section of a catheter and comprises a transmission line electrically connected to an electrode and a blind line electrically connected to a power supply unit and not forming an electrical loop;

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

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

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 includes an electrode carrier as described above and the electrode on the electrode carrier.

Optionally, the electrodes comprise an inner electrode on a side of the electrode carrier proximal to the catheter shaft and an outer electrode on a side of the electrode carrier distal to the catheter shaft, the outer electrode being closer to the distal end of the catheter shaft than the inner electrode.

In an eighth aspect, the 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 the electrophysiology 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 transmitting high-voltage pulses to the electrode assembly according to the working instruction;

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

The electrophysiology catheter and the high-voltage pulse ablation system provided by the invention have at least one of the following beneficial effects:

1) By locating at least one of the electrodes involved in the paired discharge on the side of the electrode carrier near the catheter shaft, when the target tissue is ablated by the tip electrode, the electrodes involved in the paired discharge can be made to face away from the non-target tissue or at least be hard to contact with the non-target tissue, thereby preventing the electrodes involved in the paired discharge from acting on the non-target tissue to form an unintended lesion;

2) By providing the stress diffusion member on at least one of the proximal carrier end and the distal carrier end, in the expanded state, the stress diffusion member can disperse stress applied to the at least one of the proximal carrier end and the distal carrier end, increase a bending radius of the electrode carrier corresponding to a position where the stress diffusion member is located, prevent stress concentration, and thereby avoid cracking of the electrode carrier;

3) The sizing is sleeved on the catheter shaft by disposing a sizing within the electrode assembly, the sizing 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 project outwardly away from the catheter shaft. When the electrode assembly acts on a bent blood vessel, the fixing piece is sleeved on the catheter shaft adjacent to the far end of the carrier and/or the near end of the carrier, so that the electrode carrier can still be bent in a direction away from the catheter shaft, and the electrode assembly cannot form a preset working form (such as a basket shape or a petal shape) due to bending (i.e. folding back) in a direction close to the catheter shaft;

4) The maximum distance of relative movement between the inner shaft and the outer pipe of the catheter shaft can be controlled by arranging the shaping piece, and the final expansion form of the electrode assembly is further controlled;

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

Drawings

It will be appreciated by those skilled in the art that the drawings are provided for a better understanding of the invention and do not constitute any limitation to the scope of the invention. Wherein:

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

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

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

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

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

FIG. 6 is a schematic view of a stress spreader in an activated state, according to an embodiment of the present invention;

FIG. 7 is a schematic view of one embodiment of the present invention providing a shaped element disposed at the distal end of the carrier;

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

FIG. 9 is a schematic view of a reducing swage disposed at the distal end of a carrier according to one embodiment of the present invention;

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

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

FIG. 12 is a schematic view of the connection of the tip electrode to the electrode carrier according to one embodiment of the present invention;

fig. 13 is a schematic structural diagram of an insulating layer according to an embodiment of the present invention;

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

fig. 15 is a schematic view of another high voltage pulse ablation system in accordance with an embodiment of the present invention.

Drawings

1-a catheter shaft; 2-an end electrode; 3-an electrode assembly; 4-a stress spreader; 5-shaping the profile; 6-a basket structure; 7-folding the parts;

10-an inner shaft; 11-an outer tube; 20-end electrode pads; 30-an electrode carrier; 31-an electrode; 32-a transmission line; 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-second transmission line; 323-third transmission line; 341-a first insulating layer; 342-a second insulating layer; 351-a first substrate; 352-a second substrate;

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

Detailed description of the preferred embodiments

The core idea of the invention is to provide an electrophysiology catheter and a high-voltage pulse ablation system, so as to solve the problems that in the prior art, when a ring-shaped electrode is used for high-voltage pulse ablation, the electrode is attached to a non-predetermined 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 the 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 segment of the catheter shaft;

the electrode assembly includes at least one electrode carrier and a plurality of electrodes on the electrode carrier, the tip electrode is paired with at least one of the electrodes for discharging when the tip electrode ablates the target tissue, and at least one of the electrodes involved in the paired discharge is located on a side of the electrode carrier near the catheter shaft.

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

the ablation system further comprises a cracking detection module in communication connection with the main control module, the cracking detection module is used for detecting whether the blind line is communicated with the transmission line, and if the blind line is communicated with the transmission line, a cracking signal is sent to the main control module.

at least one stress spreader disposed on at least one of the basket proximal end and the basket distal end, the stress spreader being capable of spreading stress applied to the at least one of the basket proximal end and the basket distal end in the expanded state.

the catheter further comprises a shape-fixing member arranged in the basket structure, the shape-fixing member is sleeved on the catheter shaft, and in the contraction state, the shape-fixing member acts on at least one of the basket proximal end and the basket distal end and enables the at least one of the basket proximal end and the basket distal end to protrude outwards away from the catheter shaft.

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

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

So configured, by locating at least one of the electrodes participating in the paired discharge on the side of the electrode carrier near the catheter shaft, when the target tissue is ablated with the tip electrode, the electrodes participating in the pairing can be made to face away from the non-target tissue or at least be difficult to contact with the non-target tissue, thereby preventing the electrodes participating in the pairing from acting on the non-target tissue to form an unintended lesion. In addition, by providing the stress diffusion member on at least one of the carrier proximal end and the carrier distal end, in the expanded state, the stress diffusion member can disperse stress applied to the at least one of the carrier proximal end and the carrier distal end, increase the bending radius of the electrode carrier corresponding to the position of the stress diffusion member, prevent stress concentration, and thereby avoid cracking of the electrode carrier.

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It should be noted that the drawings are in a very simplified form and are all drawn to a non-precise scale for the purpose of convenience and clarity only to aid in the description of the embodiments of the invention. To make the objects, features and advantages of the present invention comprehensible, reference is made to the accompanying drawings. It should be understood that the structures, proportions, sizes, and other elements shown in the drawings and described herein are illustrative only and are not intended to limit the scope of the invention, which is to be given the full breadth of the appended claims and any and all modifications, equivalents, and alternatives to those skilled in the art should be construed as falling within the spirit and scope of the invention.

As used in this application, 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 herein, the term "at least two" is generally employed in a sense including "two or more" unless the content clearly dictates otherwise. Furthermore, the terms "first", "second", "third" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, features defined as "first", "second", "third" may explicitly or implicitly include one or at least two of the features.

In the description of the present invention, unless otherwise expressly specified or limited, the terms "mounted," "connected," and "fixed" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral part; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled 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 a target tissue, including a catheter shaft 1 and an electrode segment disposed at a distal end 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 relative to the end electrode 2;

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

When the target tissue is ablated by the tip electrode 2, the paired electrodes 31 are prevented from acting on the non-target tissue to form an unintended lesion by positioning at least one electrode 31 of the paired electrodes 31 on the side of the electrode carrier 30 near the catheter shaft 1 so that the paired electrodes 31 can face away from the non-target tissue or at least be hard to contact with the non-target tissue. Preferably, all electrodes 31 participating in the mating discharge are located on the side of the electrode carrier 30 close to the catheter shaft 1.

It is to be understood that "proximal" and "distal" are defined herein as: "proximal" generally refers to the end of the medical device that is near the operator during normal operation, while "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 that are relatively movable to switch the electrode carrier 30 of the electrode assembly 3 between a contracted state and an expanded state. In the collapsed state, as shown in fig. 1, the electrode carrier 30 is collapsed towards the catheter shaft 1 to ensure that the catheter can safely reach the area where the target tissue is located; in the expanded state, at least a part of the electrode carrier 30 moves from a position folded toward the catheter shaft 1 to a position away from the catheter shaft 1, and when the contracted state is switched to the expanded state, the position of the electrode 31 on the electrode carrier 30 is also changed, and the technical concept of the present invention will be further explained by taking two typical expanded states, namely, a basket state (as shown in fig. 2) and a petal state (as shown in fig. 3) as an example.

In this embodiment, the catheter shaft 1 includes an inner shaft 10 and an outer tube 11, the proximal end of the carrier being disposed on the outer tube 11, the distal end of the carrier being disposed on the inner shaft 10, the inner shaft 10 and the outer tube 11 being capable of relative movement to switch the electrode carrier 30 of the electrode assembly 3 between a collapsed 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 on which the at least one electrode 31 of the electrodes 31 participating in the mating discharge is located is different from the electrode carrier 30 to which the tip electrode 2 is electrically connected. Since the electrodes 31 participating in the pairing need to transmit high voltage pulses through the transmission lines, in order to reduce the insulation design requirements of the electrode carrier 30, the transmission lines of the electrodes 31 on the electrode carrier 30 where the end electrodes 2 are located are prevented from forming high voltage insulation breakdown with the transmission lines of the end electrodes 2, and the end electrodes 2 and the electrodes 31 on different electrode carriers 30 can be subjected to pairing discharge.

Preferably, there are a plurality of electrode carriers 30 electrically connected to the end electrodes 2 to distribute the current and reduce the line width of the electrode carriers 30 carrying the current of the end electrodes 2. For cardiac ablation therapy, when the depth of an ablation focus is within a range of 3-10mm, under a voltage of 500v to 2000v, the line width of the corresponding end electrode 2 is between 0.05mm to 0.3mm, and the line width is generally considered in combination with the line thickness, which is generally a copper line of 20 um.

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

Further, the electrode assembly 3 includes a plurality of inner electrodes 310, the inner electrodes 310 being located on the side of the electrode carrier 30 near the catheter shaft 1, the inner electrodes 310 including the at least one electrode 31 of the electrodes 31 participating in the mating discharge.

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 with the inner electrode 310 is in a collapsed state, with the electrode carrier 30 collapsed toward the catheter shaft 1.

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

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

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

Further, the inner electrodes 310 have at least a third position, in which the electrode carrier 30 of the inner electrodes 310 is in an expanded state (e.g. petal state shown in fig. 3), at least one of the inner electrodes 310 can be paired with at least one of the outer electrodes 311, and at least a portion of the inner electrodes 310 and at least a portion of the outer electrodes 311 participating in the paired discharge act on the target tissue to 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, and the like, and preferably, the electrode 31 is a sheet-shaped electrode.

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

Further, the stress spreader 4 is sleeved on at least one of the carrier proximal end and the carrier distal end, and at least a portion of the stress spreader 4 is deformed by the at least one of the carrier proximal end and the carrier distal end in the expanded state. In this embodiment, the stress diffuser 4 has an initial configuration, in which, as shown in fig. 5, the stress diffuser 4 maintains its natural state, 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 segment to distribute stresses acting on the at least one of the carrier proximal end and the carrier distal end. For example, the stress spreader 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 spreader 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 tip electrode 2.

Preferably, the stress diffusion member 4 is a ring-shaped member, which is sleeved on at least one of the proximal end and the distal end of the carrier, and has a diameter corresponding to that of the end electrode 2 to ensure that the over-sheath is normal, and the length of the stress diffusion member 4 is generally between 0.5mm and 5mm, and the thickness is between 0.1mm and 0.5mm, and the stress diffusion member can be made of an elastic material such as Pebax, polyurethane, and the like. Preferably, the free end of the stress diffusion member 4 is made of an elastic material and can be fixed by adhesion with an adhesive.

Referring to fig. 7, the electrophysiology catheter 1005 further includes a shape-setting member 5 disposed within the electrode assembly 3, the shape-setting member 5 being fitted over the catheter shaft 1, and in a contracted state, the shape-setting member 5 acting on at least one of the carrier proximal end and the carrier distal end and protruding the at least one of the carrier proximal end and the carrier distal end outwardly away from the catheter shaft 1.

When the electrode assembly 3 is applied to a curved blood vessel, the shape-fixing member 5 is fitted around the catheter shaft 1 near the distal end and/or the proximal end of the carrier, so that the electrode carrier 30 can be bent away from the catheter shaft 1, and the electrode assembly 3 cannot be formed into a predetermined operating configuration (e.g., basket-like or petal-like configuration) because the electrode carrier is prevented from being bent (i.e., folded back) toward the catheter shaft 1. Furthermore, by providing the shaping element 5, even in the case of a sheet-like flexible structure of the electrode carrier 30, it is ensured that it assumes a predetermined operating configuration at the site of a curved blood vessel.

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

Preferably, the maximum outer diameter of the shape-defining member 5 is greater than the outer diameter of the circle on which the distal end of the carrier is located, so as to ensure that the distal end of the carrier is protruded outward when the electrode assembly 3 is in the contracted state, and tends to move away from the catheter shaft 1, thereby achieving the pre-defining function. When the fixed profile 5 is arranged near the proximal end of the carrier, the maximum outer diameter of the fixed profile 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 shaped part 5 is smaller than the maximum outer diameter of the outer tube 11 and the maximum outer diameter of the furled part 7 at the distal end of the carrier. Preferably, the furling member 7 is the end electrode 2 or the stress spreader 4 or other member that gathers the distal end of the carrier. It should be understood that, in the present application, the furling member 7 may be in the form of the end electrode 2 in fig. 1-3, 5-8, etc.

Further, at least one of the distal end and the proximal end of the shaped piece 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 the end of the shaped piece 5 from pressing the end of the electrode carrier 30 to cause stress concentration when the electrode carrier 30 is switched from the contracted state to the expanded state, thereby causing the electrode carrier 30 to bend and crack. For example, when the shaped element 5 is disposed on the inner shaft 10 adjacent to the distal end of the carrier, the outer diameter of the proximal end of the shaped element 5 is smaller than the inner diameter of the circle where the proximal end of the carrier is located, so that when the electrode carrier 30 is switched from the contracted state to the expanded state, the proximal end of the shaped element 5 does not press the proximal end of the carrier, thereby reducing the possibility of bending cracking.

More preferably, at least a part of the shape-fixing member 5 has a distal outer diameter close to the end electrode 2 smaller than a proximal outer diameter of the shape-fixing member 5 away from the end electrode 2, and in conjunction with fig. 8, the shape-fixing member 5 has a diameter-variable structure to better form the electrode carrier 30 into a predetermined working 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 disposed on the outer tube 11, the distal carrier end being disposed on the inner shaft 10, the shape member 5 being disposed on the inner shaft 10 adjacent the distal carrier end, the shape member 5 being configured to control the maximum distance the inner shaft 10 and the outer tube 11 of the catheter shaft 1 move relative to each other and thereby control the final form of expansion of the electrode assembly 3.

Further, when the shaped element 5 is disposed at the proximal end of the carrier, the proximal end of the carrier can be clamped and fixed by the shaped element 5 and the outer tube 11.

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

Preferably, the distance between the shaping element 5 and the end electrode 2 is not greater than 5mm. More preferably, the dimension of the shaped part 5 near the end electrode 2 is smaller than the outer diameter of the circle on which the distal end of the carrier is located, so as to reduce the movement of the shaped part 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 an electrode 31 of the electrode assembly 3, the blind line 33 is electrically connected with a power supply unit and does not form an electrical loop;

when the electrode assembly 3 is normally operated, the blind wiring 33 is not electrically conducted to the transmission wiring 32; when the electrode carrier 30 is cracked, the blind line 33 is electrically connected to the transmission line 32 and forms an electrical circuit with the energizing unit.

In a normal state, the blind line 33 is energized, and since the blind line 33 is electrically insulated from the transmission line 32, an electrical loop is not formed; when the electrode carrier 30 is cracked, the blind line 33 is exposed to the external environment, and blood can be used as a conductive medium, so that the insulation between the blind line 33 and the transmission line 32 which needs to transmit energy is failed, an electric loop is formed, and an electric current is generated, and the electric current can be detected by a crack detection module (such as a current sensor), and then whether the electrode carrier 30 is cracked or not is judged.

Preferably, the blind line 33 and the transmission line 32 are layered with each other.

Preferably, the blind wire 33 extends along the extension direction of the electrode carrier 30 at least from the carrier proximal end of the electrode carrier 30 to the carrier distal end of the electrode carrier 30 at the maximum bend in the expanded state, taking into account that the carrier distal end of the electrode carrier 30 is more likely to crack at the maximum bend in the expanded state.

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 detect the cracking of the electrode carrier 30 in time and ensure the safety of treatment.

Optionally, the electrode segment may be provided with one blind line 33, or may be provided with 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 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 this 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 corresponding substrate includes a first substrate 351 and a second substrate 352, the first transmission line 321 and the second transmission line 322 are respectively disposed on two 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 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 disposed on the substrate.

Referring to fig. 12, the terminal electrode pad 20 is electrically connected to the terminal electrode 2 through a wire, and the inside of the terminal electrode 2 may be filled with glue to ensure the connection stability between the electrode carrier 30 and the terminal electrode 2, so as to provide a buffer space when the electrode carrier 30 is switched to the expanded state, thereby preventing the connection between the terminal 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, the second transmission line layer, or a third transmission line layer independently, 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 (industrial 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 nitinol, is disposed between the first insulating layer 341 and the second insulating layer 342 to improve the shape retention capability of the electrode carrier 30.

In this embodiment, an insulating glue is filled between the insulating layer and the substrate layer for bonding between layers and insulating the transmission line.

Preferably, a superelastic memory alloy 36 is disposed in at least one of the electrode carriers 30 of the electrode assembly 3 to improve its form retention.

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

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

the energy supply unit 1001 is connected with the main control module 1002 in a communication manner and is used for delivering high-voltage pulses to the electrode segments of the electrophysiological 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 the transmission line 32 of the electrode carrier 30 of the electrode assembly, which needs to transmit energy, according to the working instruction so as to implement pairing discharge of the electrode segments;

the user interface 1004 is in communication connection with the main control module 1002 and is used for performing human-computer interaction to realize control and information display of the high-voltage pulse ablation system.

Further, the high voltage pulse ablation system comprises at least one of the following working modes:

in a first mode of operation, ablation is performed by the tip electrode 2;

in a second mode of operation, the electrode segments are in an expanded state and ablation is performed by the tip 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, the ablation through the end electrode 2 and the inner electrode 310 of the electrode assembly 3 is the most important working mode in the high-voltage pulse ablation system provided by the embodiment.

In this embodiment, in the first operation mode, the electrode segments are 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 perform paired discharge.

In this embodiment, in the second operation mode, the electrode segments are in a basket state, and ablation can be performed through the end electrode 2 and/or the outer electrode 311 of the electrode assembly 3; when ablation is performed by the tip electrode 2, the tip electrode 2 is paired with the inner side 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 is paired with the inner electrode 310.

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

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 line 33 and the transmission lines 32 that need to be discharged, so that the polarity of the blind line 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 in communication connection with 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 conducted, and if so, send a crack signal to the main control module 1002.

In a normal state, since the blind line 33 is electrically insulated from the external environment, the blind line 33 does not form an electrical loop with the transmission line 32, and the crack detection module 1006 cannot detect the current generated between the normally discharged transmission line 32 and the blind line 33. When the electrode carrier 30 cracks, the blind line 33 is exposed to the external environment, blood can be used as a conductive medium, so that the insulation between the blind line 33 and the discharged transmission line 32 is failed, an electric loop is formed, current is generated, the crack detection module 1006 can detect the current and send a crack 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 crack signal to finish treatment or provides a warning (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 energy supply unit 1001 comprises a high-voltage pulsed electric field generator capable of delivering high-voltage pulses to the blind line 33.

Preferably, the energy supply unit 1001 further comprises a low voltage generator, and in a non-discharge state, the electrode combination switch 1003 can be switched to be conductive with the low voltage generator, instead of the high voltage pulsed electric field generator energizing the blind line 33, and two poles of the low voltage generator are electrically connected with the blind line 33 and at least one of the transmission lines 32, respectively. As the low voltage generator continuously releases the low voltage signal, current may be detected in real time by the crack detection module 1006. By supplying the electrical signal to the blind line 33 via the low voltage generator, the insulation design of the electrode carrier 30 can be reduced, while at the same time the treatment safety is ensured.

On the other hand, please refer to fig. 2, fig. 5 and fig. 6, an embodiment of the present invention provides a catheter for treating a target tissue, including 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 to ensure that the catheter can safely reach an area where the target tissue is located; in the expanded state, at least a part of the basket structure 6 is moved from a position collapsed towards the catheter shaft 1 to a position away from the catheter shaft 1;

the basket structure 6 comprises a proximal basket end and a distal basket end, which are relatively movable to switch the basket structure 6 between the collapsed state and the expanded state;

at least one stress diffuser 4 disposed on at least one of the basket proximal end and the basket distal end, wherein in the expanded state, the stress diffuser 4 is capable of dispersing stress applied to the at least one of the basket proximal end and the basket distal end, increasing a bending radius of the basket structure 6 corresponding to a position of the stress diffuser 4, and preventing stress concentration, thereby preventing the basket structure 6 from cracking and preventing the basket proximal end and the basket distal end from failing to return to their collapsed states under excessive stress.

In this embodiment, the basket structure 6 includes, but is not limited to, the electrode assembly 3 of the previous embodiments. The catheter includes, but is not limited to, the electrophysiology catheter 1005 of the previous embodiments. 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 diffusion member 4 is fitted over at least one of the basket proximal end and the basket distal end, and at least a portion of the stress diffusion member 4 is deformed by the at least one of the basket proximal end and the basket distal end in the expanded state. In this embodiment, the stress diffuser 4 has an initial configuration in which the stress diffuser 4 maintains its natural state and an active configuration; in the active configuration, at least a portion of the stress spreader 4 is deformed by the end section to spread stresses applied to the at least one of the basket proximal end and the basket distal end.

Preferably, the stress dispersion member 4 is a ring-shaped member, which is sleeved on at least one of the basket proximal end and the basket distal end, and the length of the stress dispersion member 4 is generally between 0.5mm and 5mm, and the thickness thereof is between 0.1mm and 0.5mm, and the stress dispersion member can be made of an elastic material such as Pebax, polyurethane, etc. Preferably, the free end of the stress diffusion member 4 is made of an elastic material and can be fixed by adhesion with an adhesive.

Further, referring to fig. 7, the catheter further comprises a fixing member 5 disposed in the basket structure 6, wherein the fixing member 5 is sleeved on the catheter shaft 1, and in a contracted state, the fixing member 5 acts on at least one of the basket proximal end and the basket distal end to make the at least one of the basket proximal end and the basket distal end protrude outwards away from the catheter shaft 1. When the catheter is used for bending blood vessels, the positioning piece 5 is sleeved on the catheter shaft 1 adjacent to the far end and/or the near end of the mesh basket, so that the mesh basket structure 6 can still be bent in the direction away from the catheter shaft 1, and the mesh basket structure 6 cannot form a preset working state due to the fact that the mesh basket structure 6 is bent (i.e. reversely folded) in the direction close to the catheter shaft 1. Furthermore, by providing the shape-defining element 5, the basket structure 6 can be ensured to form a predetermined operating configuration at the site of a curved blood vessel even when it is a sheet-like flexible structure.

Further, the catheter shaft 1 includes an inner shaft 10 and an outer tube 11, the inner shaft 10 and the outer tube 11 being relatively movable, the basket proximal end being disposed on the outer tube 11, and the basket distal end being disposed on the inner shaft 10. When the shaped piece 5 is disposed adjacent to the basket distal end, the shaped piece 5 may be disposed on the inner shaft 10 of the catheter shaft 1; when the profile 5 is arranged adjacent to the basket proximal end, the profile 5 may be arranged on the outer tube 11 of the catheter shaft 1, alternatively on the inner shaft 10 movably relative to the inner shaft 10.

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

Preferably, the maximum outer diameter of the shape-defining piece 5 is greater than the outer diameter of the circle in which the basket distal end is located, so as to ensure that the basket distal end protrudes outwardly when the basket structure 6 is in the collapsed state, thereby tending to move away from the catheter shaft 1 and defining the shape in advance. When the fixed part 5 is arranged near the net basket proximal end, the maximum outer diameter of the fixed part 5 is larger than the outer diameter of the circle where the net basket proximal end is located. More preferably, the maximum outer diameter of the shaped member 5 is smaller than the maximum outer diameter of the outer tube 11 and the maximum outer diameter of the furling member 7 at the far end of the net basket.

Further, at least one of the distal end and the proximal end of the shape fixing element 5 has a radial dimension 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 shape fixing element 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 basket structure 6 to bend and crack. For example, when the shape-fixing element 5 is disposed on the inner shaft 10 adjacent to the basket distal end, the outer diameter of the proximal end of the shape-fixing element 5 is smaller than the inner diameter of the circle where the basket proximal end is located, so that when the basket structure 6 is switched from the contracted state to the expanded state, the proximal end of the shape-fixing element 5 does not press the basket proximal end, thereby reducing the possibility of bending and cracking.

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

The fixed part 5 may be made of Pebax (polyether block polyamide), polyurethane, or other elastic materials, and the fixed part 5 is fixed to the inner shaft 10 or the outer tube 11 by adhesion.

Preferably, the length of the shaped part 5 is between 1mm and 5mm.

Preferably, the distance between the fixed member 5 and the furling member 7 arranged on the catheter shaft 1 for furling the far end of the net basket is not more than 5mm. Preferably, the furling member 7 is the end electrode 2 or the stress diffuser 4 or other member for gathering the basket distal end.

Preferably, the basket structure 6 includes a superelastic memory alloy 36 to improve the form retention of the basket structure 6.

In another aspect, in combination with fig. 2 and 7, an embodiment of the present invention provides a catheter for treating a target tissue, including a catheter shaft 1 and a basket structure 6, wherein the basket structure 6 is disposed at a distal 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 to ensure that the catheter can safely reach an area where the target tissue is located; in the expanded state, at least a part of the basket structure 6 is moved from a position collapsed towards the catheter shaft 1 to a position away from the catheter shaft 1;

the basket structure 6 comprises a basket proximal end and a basket distal end that are relatively movable to switch the basket structure 6 between the collapsed state and the expanded state;

the catheter further comprises a shaping piece 5 arranged in the basket structure 6, the shaping piece 5 is sleeved on the catheter shaft 1, and in the contraction state, the shaping piece 5 acts on at least one of the basket proximal end and the basket distal end and enables the at least one of the basket proximal end and the basket distal end to bulge 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 embodiments. The catheter includes, but is not limited to, the electrophysiology catheter 1005 of the previous embodiments.

On the other hand, in conjunction with fig. 2 and 10, the embodiment of the present invention provides an electrode carrier which can be disposed at the distal section of a catheter and includes a transmission line 32 and a blind line 33, wherein the transmission line 32 is electrically connected with an electrode 31, and the blind line 33 is electrically connected with a power supply unit and does not form an electric loop;

when the electrode carrier 30 is normally operated, the blind wiring 33 is not electrically conducted to the transmission wiring 32; when the electrode carrier 30 is cracked, the blind line 33 is electrically conducted with the transmission line 32 and forms an electric circuit with the power supply unit.

In a normal state, the blind line 33 is energized, and since the blind line 33 is electrically insulated from the transmission line 32, an electrical loop is not formed; when the electrode carrier 30 is cracked, the blind line 33 is exposed to the external environment, and blood can be used as a conductive medium, so that the insulation between the blind line 33 and the transmission line 32 which needs to transmit energy is failed, an electric loop is formed, and an electric current is generated, and the electric current can be detected by a crack detection module (such as a current sensor), and then whether the electrode carrier 30 is cracked or not is judged. The crack can also be detected by an impedance value detection method, and the impedance detection is carried out by using high frequency and low voltage (1KHz to 100kHz, below 5V).

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

In another aspect, in conjunction with fig. 1-4, an embodiment of the present invention provides an electrophysiology catheter 1005 for ablating a 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 includes an electrode carrier 30 as described above and the electrode 31 on the electrode carrier 30.

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

In another aspect, in conjunction with 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 work instruction;

the energy supply unit 1001 is in communication connection with the main control module 1002 and is used for transmitting high-voltage pulses to the electrode assembly 3 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 the transmission line 32 that needs to transmit energy according to the working instruction so as to implement pairing discharge of the electrode assembly 3;

the user interface 1004 is in communication connection with the main control module 1002, and is used for performing human-computer interaction, so as to realize control and information display of the high-voltage pulse ablation system;

the power supply unit 1001 is further configured to energize the blind line 33 and the transmission line 32 to be discharged, such that the polarity of the blind line 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 connection with the main control module 1002, wherein the crack detection module 1006 is configured to detect whether the blind line 33 and the transmission line 32 are connected, and if the blind line 33 and the transmission line 32 are connected, send a crack signal to the main control module 1002.

Preferably, the energy supply unit 1001 further comprises a low voltage generator, and in a non-discharge state, the electrode combination switch 1003 can be switched to be conductive with the low voltage generator, instead of the high voltage pulsed electric field generator energizing the blind line 33, and two poles of the low voltage generator are electrically connected with the blind line 33 and at least one of the transmission lines 32, respectively. Since the low voltage generator continuously releases the low voltage signal, the current may be detected in real time by the crack detection module 1006. By supplying the electrical signal to the blind line 33 via the low voltage generator, the insulation design of the electrode carrier 30 can be reduced, while at the same time the treatment safety is ensured.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the present invention. It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, it is intended that the present invention also include such modifications and variations as come within the scope of the invention and their equivalents.

Claims

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

2. The electrophysiology catheter of claim 1, wherein the electrode assembly includes a number of inner electrodes on a side of the electrode carrier proximate the catheter shaft, the inner electrodes including the at least one of the electrodes participating in the mating discharge.

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

4. The electrophysiology catheter of any one of claims 1-3, wherein the electrode carrier on which the at least one of the electrodes participating in the mating discharge is electrically connected to the tip electrode is a different electrode carrier.

5. The electrophysiology catheter according to claim 4, wherein an electrode carrier on which the at least one of the electrodes participating in the mating discharge is located and an electrode carrier to which the tip electrode is electrically connected are alternately disposed in a circumferential direction of the catheter shaft.

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

7. The electrophysiology catheter of any one of claims 2, 3, 6, wherein the electrode assembly further includes a plurality 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.

8. The electrophysiology catheter of claim 7, wherein the inner electrode has at least a third position in which the electrode carrier of the inner electrode 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.

9. The electrophysiology catheter of any one of claims 1-3, 5, 6, 8, wherein 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 relatively movable to switch the electrode carrier of the electrode assembly between the collapsed state and the expanded state.

10. The electrophysiology catheter of claim 9, further comprising at least one stress spreader disposed on at least one of the carrier proximal end and the carrier distal end, the stress spreader being capable of spreading stress applied to the at least one of the carrier proximal end and the carrier distal end in the expanded state.

11. The electrophysiology catheter of claim 10, wherein the stress spreader is disposed over at least one of the carrier proximal end and the carrier distal end, and wherein at least a portion of the stress spreader is deformed by the at least one of the carrier proximal end and the carrier distal end in the expanded state.

12. The electrophysiology catheter of claim 9, further comprising a sizing disposed within the electrode assembly, the sizing being sleeved on the catheter shaft, the sizing acting on at least one of the carrier proximal end and the carrier distal end in a collapsed state and projecting the at least one of the carrier proximal end and the carrier distal end outward away from the catheter shaft.

13. The electrophysiology catheter of claim 12, wherein the catheter shaft includes an inner shaft and an outer tube, the inner and outer tubes being relatively movable, the carrier proximal end disposed on the outer tube, the carrier distal end disposed on the inner shaft;

the sizer is disposed over the inner shaft adjacent the carrier distal end.

14. The electrophysiology catheter of claim 12, wherein the shape member is of a reducing configuration to form the electrode carrier into a predetermined working configuration.

15. The electrophysiology catheter of claim 12, wherein at least one of the distal end and the proximal end of the shaping member has a radial dimension that is no greater than an inner diameter of a circle in which the ends of the electrode carrier lie.

16. The electrophysiology catheter of any one of claims 12-15, wherein the length of the shape-defining piece is between 1mm-5 mm.

17. The electrophysiology catheter of any one of claims 12-15, wherein the spacing of the shaping element from a gathering element disposed on the catheter shaft for gathering the distal end of the carrier is no greater than 5mm.

18. The electrophysiology catheter of any one of claims 1-3, 5, 6, 8, 10-15, wherein at least one electrode carrier of the electrode assembly includes a transmission line electrically connected to an electrode of the electrode assembly and a blind line electrically connected to an energizing unit and not forming an electrical loop;

19. The electrophysiology catheter of claim 18, wherein the electrode carrier further comprises an insulating layer and a base, the transmission line is disposed on the insulating layer, the base covers the transmission line, and the electrode is disposed on the other side of the base relative to the transmission line and is electrically connected to the transmission line.

20. The electrophysiology catheter according to claim 18, wherein the blind wire 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.

21. The electrophysiology catheter of claim 18, wherein the blind wire is disposed closer to an outside of the electrode carrier than the transmission line.

22. The electrophysiology catheter of any one of claims 1-3, 5, 6, 8, 10-15, 19-21, wherein there are a plurality of electrode carriers electrically connected to the tip electrode.

23. The electrophysiology catheter of any of claims 1-3, 5, 6, 8, 10-15, and 19-21, wherein a superelastic memory alloy is disposed in at least one electrode carrier of the electrode assembly to improve its form retention.

24. 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 of claims 1-23;

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

25. The high voltage pulse ablation system according to claim 24, comprising at least one of the following modes of operation:

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

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

26. The high voltage pulse ablation system according to claim 25, wherein the main control module is capable of selectively controlling the tip electrode, the outer electrode, and the inner electrode.

27. 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 of claims 18-21;

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

28. The high voltage pulse ablation system according to claim 27, wherein the energy supply unit delivers high voltage pulses to the blind circuit.

29. The hp pulse ablation system according to claim 27, wherein the energy supply unit further comprises a low voltage generator, and in a non-discharge state, the electrode combination switch is switchable into conduction with the low voltage generator, and two poles of the low voltage generator are electrically connected to the blind line and at least one of the transmission lines, respectively.

30. A catheter for treating a target tissue, comprising a catheter shaft and a basket structure disposed at a distal section of the catheter shaft and having a collapsed state in which the basket structure is collapsed against the catheter shaft to ensure that the catheter can safely reach the area of the target tissue and an expanded state; in the expanded state, at least a portion of the basket structure moves from a collapsed position toward the catheter shaft to a position away from the catheter shaft;

31. The catheter of claim 30, wherein the stress spreader is sleeved over at least one of the basket proximal end and the basket distal end, and wherein at least a portion of the stress spreader is deformed by the at least one of the basket proximal end and the basket distal end in the expanded state.

32. The catheter of claim 30 or 31, further comprising a shape-setting member disposed within the basket structure, the shape-setting member being sleeved on the catheter shaft, the shape-setting member acting on and bulging at least one of the basket proximal end and the basket distal end outward away from the catheter shaft in a collapsed state.

33. The catheter of claim 32, wherein the catheter shaft includes an inner shaft and an outer tube, the inner and outer tubes being relatively movable, the basket proximal end being disposed on the outer tube, the basket distal end being disposed on the inner shaft; the profile is disposed on the inner shaft adjacent the basket distal end.

34. The catheter of claim 32, wherein the shape member is a tapered structure to form the electrode carrier into a predetermined working configuration.

35. The catheter of claim 32, wherein at least one of the distal end and the proximal end of the shaping member has a radial dimension that is no greater than an inner diameter of a circle in which the ends of the electrode carrier lie.

36. The catheter of any one of claims 33-35, wherein the shape member is between 1mm-5mm in length.

37. The catheter of any one of claims 33-35, wherein the spacing of the shape-defining member from a gathering member provided on the catheter shaft for gathering the distal end of the basket is no greater than 5mm.

38. The catheter of any one of claims 30, 31, 33-35, wherein the basket structure comprises a superelastic memory alloy to improve the shape retention capability of the basket structure.

39. A catheter for treating a target tissue, comprising a catheter shaft and a basket structure disposed at a distal section of the catheter shaft and having a collapsed state in which the basket structure is collapsed against the catheter shaft to ensure that the catheter can safely reach an area where the target tissue is located 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 away 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 relatively movable to switch the basket structure between the collapsed state and the expanded state;

40. The catheter of claim 39, wherein the catheter shaft includes an inner shaft and an outer tube, the inner and outer tubes being relatively movable, the basket proximal end being disposed on the outer tube and the basket distal end being disposed on the inner tube;

the shape-fixing piece is arranged on the inner pipe adjacent to the far end of the net basket.

41. A catheter according to claim 39, wherein the shape member is of a tapered configuration to provide the electrode carrier with a predetermined working configuration.

42. The catheter of claim 39, wherein at least one of the distal end and the proximal end of the shaping member has a radial dimension that is no greater than an inner diameter of a circle in which the ends of the electrode carrier lie.

43. A catheter according to any of claims 39-42, wherein the length of the shape member is between 1mm-5 mm.

44. The catheter of any one of claims 39-42, wherein the spacing of the shape-defining member from a gathering member provided on the catheter shaft for gathering the distal end of the basket is no greater than 5mm.

45. An electrode carrier, characterized in that it can be arranged at a distal section of a catheter and comprises a transmission line electrically connected to an electrode and a blind line electrically connected to an energizing unit and not forming an electrical circuit;

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

46. The electrode carrier as claimed in claim 45, further comprising an insulating layer and a substrate, wherein the transmission line is disposed on the insulating layer, wherein the substrate covers the transmission line, and wherein 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.

47. The electrode carrier according to claim 45 or 46, wherein the blind track extends along the extension direction of the electrode carrier at least from the carrier proximal end of the electrode carrier to the maximum bend of the carrier distal end of the electrode carrier in the expanded state.

48. Electrode carrier in accordance with claim 45 or 46 characterized in that the blind line is arranged closer to the outer side of the electrode carrier than to the transmission line.

49. The electrode carrier according to claim 45 or 46, wherein a superelastic memory alloy is provided in the electrode carrier to improve its form-retaining ability.

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

the electrode assembly comprising an electrode carrier according to any one of claims 45 to 49 and the electrode located on the electrode carrier.

51. The electrophysiology catheter of claim 50, wherein the electrodes include an inner electrode on a side of the electrode carrier proximal to 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 the distal end of the catheter shaft than the inner electrode.

52. 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 claim 50 or 51;

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

53. The high voltage pulse ablation system according to claim 52, wherein the energy supply unit delivers high voltage pulses to the blind circuit.

54. The hp pulse ablation system according to claim 52, wherein said power supply unit further comprises a low voltage generator, said electrode combination switch being switchable into conduction with said low voltage generator in a non-discharge state, two poles of said low voltage generator being electrically connected to said blind line and to at least one of said transmission lines, respectively.