CN117796895A - Steep pulse ablation catheter and equipment - Google Patents

Abstract

The invention discloses a steep pulse ablation catheter and equipment, comprising an introduction unit, an energy application unit, a first contraction assembly and a second contraction assembly, wherein the energy application unit is arranged on the introduction unit, and the introduction unit is used for driving the energy application unit to enter or leave a target channel; the introducing unit comprises an inner introducing piece and an outer introducing piece; the energy application unit includes at least one pair of energy application elastic elements, each pair of energy application elastic elements including a positive energy application elastic element and a negative energy application elastic element, the positive energy application elastic element and the negative energy application elastic element being configured to elastically expand into an operative configuration by an elastic force, the positive energy application elastic element and the negative energy application elastic element being configured to conform to and support the target passageway in the operative configuration to achieve positioning in the target passageway such that it is relatively stationary with respect to the target tissue. The invention has reliable structure, high realizability, convenient operation, difficult adhesion generation and better ablation effect.

Description

Steep pulse ablation catheter and equipment

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a steep pulse ablation catheter and equipment.

Background

A steep pulse ablation catheter is a device that uses a high voltage pulsed electric field to ablate. Pulsed field ablation (Pulse Field Ablation, PFA) is a technique that uses high voltage discharge to produce irreversible electroporation of cells, which can act directly on cells to cause apoptosis for therapeutic purposes. The irreversible electroporation ablation technique utilized for pulsed field ablation is a non-heating ablation technique, and has some theoretical advantages over other ablation methods.

Firstly, the ablation time of irreversible electroporation is very short; secondly, since irreversible electroporation is non-thermal ablation, no heat sink effect can produce complete cell death around the blood vessel (unlike thermal ablation, blood flow in the blood vessel takes away heat, resulting in incomplete inactivation of cells around the blood vessel);

furthermore, irreversible electroporation can form numerous irreversible nanometer holes on the cell membrane to destroy the lipid bilayer structure of the cell membrane and the stability of the intracellular environment, and the irreversible electroporation can theoretically retain the structures around the cell matrix and the cell, and the structures and functions of large blood vessels, biliary tracts, intestinal tracts, nerves and the like are still intact;

In addition, the mechanism by which irreversible electroporation causes cell death is apoptosis, not necrosis. The apoptosis has the advantages that the apoptotic cells are cleared through immune intervention, and the phagocytes clear the apoptotic cells as the death process of the normal cells, so that the regeneration and repair of the normal tissues are promoted, and therefore, the treatment area can be replaced by the normal cells in a short time after irreversible electroporation treatment, so that the original functions are restored.

The radio frequency ablation catheter is initially applied and is used for treating hemangiomas and other human lumen lesion sites, and the treatment is initially shown to have the advantages of definite curative effect, high safety, small wound, low recurrence rate and the like; later in the course of treatment it was found that: 1. the existing radio frequency ablation catheter has generally poor adaptability to the curved blood vessel, and most of the radio frequency ablation catheters cannot be attached to the electrode in the curved blood vessel at all, so that if a new radio frequency ablation catheter can improve the coverage to the curved blood vessel at the same time, the application range of the radio frequency ablation can be greatly expanded, the radio frequency ablation effect can be improved at the same time, and the radio frequency ablation catheter has a positive effect on popularization of the radio frequency ablation. 2. Because the radiofrequency ablation catheter uses the thermal ablation principle, the coagulated tissue after ablation can be adhered to the surface of the electrode, and the electrode is easy to tear to normal tissue when withdrawn, so that secondary hemorrhage is caused; furthermore, after the surface of the electrode is wrapped by the solidified tissue, the radio frequency energy transmission medium (liquid polar molecules) on the surface of the electrode is isolated, so that the radio frequency energy cannot be continuously output.

At present, high-voltage pulse field ablation is used as a new effective ablation treatment mode, is continuously popularized and applied in interventional treatment methods, and is also popularized and applied in the treatment of diseases of natural human body cavities. The high-voltage pulse ablation catheter is designed and developed to have electrodes which are matched with the lumen for interventional ablation treatment of different natural human body passages and different lesion parts, so that the lesion parts are positioned and ablated more accurately, and the treatment effect is better.

The invention patent publication No. CN113317868A discloses a pulse field ablation catheter and apparatus. The pulse field ablation catheter comprises an inner tube and an elastic deformation body; the elastic deformation body is arranged at the front end of the inner tube, and at least one end of the elastic deformation body is fixedly connected with the inner tube; the middle portion of the elastic deformation body can expand or contract, and when the elastic deformation body contracts, the inner surface of the elastic deformation body is at least partially fitted with the inner tube.

The prior art has the problem that irreversible electroporation (irreversible electroporation, IRE) ablation technology is an emerging treatment means, and the technology can destroy the cell membrane structure of a tumor by applying a high-voltage pulse electric field with microsecond pulse width around the tumor cells to form a plurality of hydrophilic micropores, and finally, the cells die. Because of the technical principle, peripheral blood vessels, nerves and the like are not damaged, and lumen walls such as bile ducts, pancreatic ducts, intestinal ducts and the like are not ablated and perforated, but the scheme that the existing part of steep pulse catheter technology is used for various lumen structures of a human body is realized, most of the existing schemes only stay in a theoretical stage at present, and an integral and feasible solution is not presented.

Disclosure of Invention

In view of the problems in the background art, it is an object of the present invention to provide a steep pulse ablation catheter for ablating target tissue within a target pathway, comprising an introduction unit, an energy application unit, a first retraction assembly and a second retraction assembly, the energy application unit being provided on the introduction unit, the introduction unit being for driving the energy application unit into or out of the target pathway, the energy application unit being for applying energy to the target tissue to ablate the same;

the introducing unit comprises an inner introducing part and an outer introducing part which are mutually nested, the outer introducing part can move relative to the inner introducing part, and the outer introducing part at least has a first position at a far end and a second position at a near end when moving relative to the inner introducing part;

the energy applying unit comprises at least one pair of energy applying elastic elements, each pair of the energy applying elastic elements comprises a positive energy applying elastic element connected with a positive electrode and a negative energy applying elastic element connected with a negative electrode, the positive energy applying elastic element and the negative energy applying elastic element of each pair of the energy applying elastic elements are alternately arranged on the inner guide piece at intervals along the length direction of the inner guide piece in turn, and the positive energy applying elastic element and the negative energy applying elastic element are configured to be elastically expanded into an operating configuration through elastic force and elastically contracted into a conveying configuration through the action of the first contraction assembly or the second contraction assembly; the positive energy applying resilient element and the negative energy applying resilient element are configured to conform to and support the target passageway in the operative configuration to achieve positioning in the target passageway such that it is relatively stationary with respect to the target tissue;

The first contraction assembly is the outer introduction member which constrains the positive energy application elastic element and the negative energy application elastic element into the delivery configuration when the introduction unit drives the energy application unit to enter the target channel and the outer introduction member is in the first position state; when the outer introducing member is in the second position state, the outer introducing member releases the positive energy applying elastic element and the negative energy applying elastic element to elastically expand into the working configuration by elastic force;

the introduction unit causes the positive energy application elastic element and the negative energy application elastic element to retract into the delivery configuration through the first retraction assembly or the second retraction assembly as the energy application unit is moved away from the target pathway.

Preferably, one end of the positive energy application elastic element and one end of the negative energy application elastic element are fixed ends, are in a radial shrinkage state, are fixedly connected with the inner guide piece, and the other end of the positive energy application elastic element and the negative energy application elastic element are open ends, and are in a radial expansion state when in the working configuration, and are symmetrically arranged between the adjacent positive energy application elastic element and the adjacent negative energy application elastic element;

When the introducing unit drives the energy applying unit to leave the target channel, the outer introducing piece drives the positive energy applying elastic element and the negative energy applying elastic element with the open ends facing to the distal end to change into the conveying configuration, and the distal end of the outer introducing piece is sleeved into the positive energy applying elastic element and the negative energy applying elastic element through the fixed end and applies force to the positive energy applying elastic element and the negative energy applying elastic element to enable the positive energy applying elastic element and the negative energy applying elastic element to elastically shrink into the conveying configuration; the outer introducer is constrained between the outer introducer and the inner introducer via the open end after the positive and negative energy-applying elastic elements are driven proximally by the second retraction assembly to change to the delivery configuration.

Preferably, the second retraction assembly comprises a driving element and a force transfer element, wherein the driving element surrounds and wraps the inner introduction piece and is positioned on one side of the positive energy application elastic element and one side of the negative energy application elastic element, which are oriented towards the distal end, the force transfer element extends from the proximal end of the inner introduction piece to the driving element and is fixedly connected with the driving element, the driving element is driven to move towards the proximal end through the force transfer element, and the driving element is sleeved on the driving element through the fixed end of the energy application elastic element and applies force to drive the driving element to change into the conveying configuration.

Preferably, the driving element is a driving ring, the driving ring is sleeved on the inner guiding piece, the force transmission element is a driving wire, the inner guiding piece is hollow, and the driving wire is arranged in the inner guiding piece in a penetrating way;

the driving wire penetrates through the inner guide piece and is fixedly connected with the driving ring when extending from the proximal end to a position close to the driving ring, and the driving wire is pulled towards the proximal end to drive the driving ring to move towards the proximal end so as to drive the positive energy application elastic element and the negative energy application elastic element to change into the conveying configuration.

Preferably, the inner guiding member is an inner tube, the outer guiding member is an outer tube, the outer tube is sleeved on the inner tube, and a gap for accommodating the positive energy application elastic element and the negative energy application elastic element is arranged between the outer tube and the inner tube.

Preferably, the positive energy application elastic element and the negative energy application elastic element are annular elastic mesh electrodes.

Preferably, the device comprises a flexible guiding element penetrating the inner guiding element and extending to one side of the inner guiding element facing the distal end, wherein the flexible guiding element is used for guiding the inner guiding element and the outer guiding element to move in the target channel.

Preferably, the flexible guide element is a guide wire extending from a proximal end to a distal end and penetrating the distal end of the inner guide member into the target passageway, the guide wire being disposed in the target passageway in a curved configuration along a target path, the inner guide member and the outer guide member being movable along the guide wire.

Based on the same conception, the invention also provides a steep pulse ablation device which is used for ablating target tissues in a target channel and comprises a steep pulse ablation catheter and a control unit, wherein the control unit is arranged at the proximal end of the steep pulse ablation catheter and is used for driving the steep pulse ablation catheter to enter the target channel;

the steep pulse ablation catheter comprises an introduction unit, an energy application unit, a first contraction assembly and a second contraction assembly, wherein the energy application unit is arranged on the introduction unit and is used for driving the energy application unit to enter or leave the target channel, and the energy application unit is used for applying energy to the target tissue so as to ablate the target tissue;

the introducing unit comprises an inner introducing part and an outer introducing part which are mutually nested, the outer introducing part can move relative to the inner introducing part, and the outer introducing part at least has a first position at a far end and a second position at a near end when moving relative to the inner introducing part;

The energy applying unit comprises at least one pair of energy applying elastic elements, each pair of the energy applying elastic elements comprises a positive energy applying elastic element connected with a positive electrode and a negative energy applying elastic element connected with a negative electrode, the positive energy applying elastic element and the negative energy applying elastic element of each pair of the energy applying elastic elements are alternately arranged on the inner guide piece at intervals along the length direction of the inner guide piece in turn, and the positive energy applying elastic element and the negative energy applying elastic element are configured to be elastically expanded into an operating configuration through elastic force and elastically contracted into a conveying configuration through the action of the first contraction assembly or the second contraction assembly; the positive energy applying resilient element and the negative energy applying resilient element are configured to conform to and support the target passageway in the operative configuration to achieve positioning in the target passageway such that it is relatively stationary with respect to the target tissue;

the first contraction assembly is the outer introduction member which constrains the positive energy application elastic element and the negative energy application elastic element into the delivery configuration when the introduction unit drives the energy application unit to enter the target channel and the outer introduction member is in the first position state; when the outer introducing member is in the second position state, the outer introducing member releases the positive energy applying elastic element and the negative energy applying elastic element to elastically expand into the working configuration by elastic force;

The introduction unit drives the energy application unit to leave the target channel, and the positive energy application elastic element and the negative energy application elastic element are contracted into the conveying configuration through the first contraction assembly or the second contraction assembly;

the control unit comprises a first control element and a second control element, the first control element is movably connected with the second control element, the first control element can move towards the near end or the far end relative to the second control element, a locking component is further arranged between the first control element and the second control element, and the locking component can lock the first control element and the second control element to fix the relative positions of the first control element and the second control element; the first control element is connected with the outer guide-in part, the second control element is connected with the inner guide-in part, and the first control element can drive the outer guide-in part to move relative to the inner guide-in part when moving relative to the second control element.

Preferably, the first control element is a three-way connector, and the three-way connector is hollow and is provided with a first interface, a second interface and a third interface which are communicated with the interior of the three-way connector;

The first interface is arranged at the far end of the three-way connector, the first interface is connected with the near end of the outer guide-in part, and the inner part of the outer guide-in part is hollow and is communicated with the three-way connector through the first interface;

the second interface is used for injecting liquid medicine into the three-way connector piece and the outer guide piece, and the liquid medicine enters the energy applying unit in the target channel through the distal end of the outer guide piece;

the third interface is arranged at the proximal end of the three-way joint piece, and the second control element is arranged in the three-way joint piece in a penetrating way through the third interface and is connected with the inner guide-in piece through the first interface.

Preferably, the locking component is arranged at the third interface of the three-way connector piece, and comprises a sealing plug and a locking nut;

the sealing plug is arranged in the three-way joint piece and is in sealing connection with the inner wall of the three-way joint piece, and the distal end of the sealing plug is mutually abutted with the abutting part in the three-way joint piece; a through hole is formed in the sealing plug, and the second control element penetrates through the through hole;

the lock nut is in threaded connection with the third interface, an extrusion part is arranged in the lock nut, the extrusion part is in butt joint with the proximal end of the sealing plug through the threaded locking force of the lock nut and compresses the proximal end of the sealing plug, so that the sealing plug and the second control element are tightly sealed in a tensioning manner, and the second control element and the three-way connector piece are mutually locked through the tensioning force.

Preferably, the inner guiding member is hollow, the second control element comprises a hollow connecting member and a main body member, the connecting member is movably connected with the first control element, and the distal end of the connecting member is communicated with the inner guiding member, and the proximal end of the connecting member is communicated with the main body member.

Preferably, one end of the positive energy application elastic element and one end of the negative energy application elastic element are fixed ends, are in a radial shrinkage state, are fixedly connected with the inner guide piece, and the other end of the positive energy application elastic element and the negative energy application elastic element are open ends, and are in a radial expansion state when in the working configuration, and are symmetrically arranged between the adjacent positive energy application elastic element and the adjacent negative energy application elastic element;

when the introducing unit drives the energy applying unit to leave the target channel, the outer introducing piece drives the positive energy applying elastic element and the negative energy applying elastic element with the open ends facing to the distal end to change into the conveying configuration, and the distal end of the outer introducing piece is sleeved into the positive energy applying elastic element and the negative energy applying elastic element through the fixed end and applies force to the positive energy applying elastic element and the negative energy applying elastic element to enable the positive energy applying elastic element and the negative energy applying elastic element to elastically shrink into the conveying configuration; the outer introducer being constrained between the outer introducer and the inner introducer via the open end after the positive and negative energy-applying elastic elements, driven proximally by the second retraction assembly, change to the delivery configuration;

The second contraction assembly comprises a driving element and a force transmission element, wherein the driving element surrounds and is coated on the inner introduction piece and is positioned on one side of the positive energy application elastic element and one side of the negative energy application elastic element, which are oriented towards the distal end, the force transmission element extends from the proximal end of the inner introduction piece to the driving element and is fixedly connected with the driving element, the driving element is driven by the force transmission element to move towards the proximal end, and the driving element is sleeved on the driving element through the fixed end of the energy application elastic element and applies force to drive the driving element to change into the conveying configuration;

the force transfer element is arranged in the inner guide-in part, the connecting part and the main body part in a penetrating way, the main body part is connected with a control part in a sliding way, the control part is connected with the force transfer element, and the control part is slid to drive the force transfer element and the driving element to move towards the near end.

Preferably, the main body member is provided with a wire port, and wires for supplying energy to the positive energy application elastic element and the negative energy application elastic element enter the main body member through the wire port and are electrically connected with the energy application elastic element through the connecting member and the inner guide member in sequence.

Preferably, the device comprises a flexible guiding element penetrating the inner guiding piece and extending to one side of the inner guiding piece facing to the distal end, wherein the flexible guiding element is used for guiding the inner guiding piece and the outer guiding piece to move in the target channel;

the main body piece is provided with a guide opening, and the flexible guide element enters the main body piece through the guide opening and penetrates through the inner guide piece through the connecting piece.

By adopting the technical scheme, the invention has the following advantages and positive effects compared with the prior art:

1. the positive and negative energy-imparting resilient elements of the present invention are configured to change between an elastically expanded, operative configuration and an elastically contracted, delivery configuration, which in the delivery configuration may be constrained between the outer and inner introducers so as to smoothly shuttle in the target pathway. When the device is in the working configuration, the positive energy application elastic element and the negative energy application elastic element can be adaptively adjusted to be abutted against and supported by the target channel, and can be matched with the target channel to realize positioning in the target channel, so that the energy application elastic element corresponds to target tissue and is kept relatively static, better lamination can be realized, and the effect of ablating the target tissue is enhanced. Meanwhile, the steep pulse ablation catheter has the advantages of reliable structure, high realizability, convenient operation, difficult adhesion generation and better ablation effect.

2. The adjacent positive energy application elastic element and the adjacent negative energy application elastic element are symmetrically arranged, so that an energy field formed by the positive energy application elastic element and the negative energy application elastic element is more uniform, and the ablation effect is better.

3. The invention is provided with a flexible guiding element which can guide the inner guiding element and the outer guiding element to move in the target channel, and particularly when the target channel turns or branches, the inner guiding element and the outer guiding element can be smoothly guided to the target tissue by the flexible guiding element.

4. The invention is provided with a control unit, the control unit comprises a first control element and a second control element, the movement of the outer guide-in part and the movement of the inner guide-in part can be controlled respectively, and the liquid medicine can be injected into the target channel through the first control element, so that the functionality of the device is greatly enhanced, for example, a developer, physiological saline and the like can be injected into the target channel, the ultrasonic detectability of the developer can be enhanced, the conductivity around the energy-applying elastic element can be enhanced by the physiological saline, and the ablation effect is improved.

Drawings

The invention is described in further detail below with reference to the attached drawing figures, wherein:

FIG. 1 is a schematic diagram of a steep pulse ablation device according to the invention;

FIG. 2 is a schematic view of a steep pulse ablation catheter in accordance with the present invention;

FIG. 3 is a schematic view of a tee fitting of the present invention;

FIG. 4 is a schematic view of a body member of the present invention;

FIG. 5 is a cross-sectional view of an inner tube of the present invention;

FIG. 6 is a cross-sectional view of a three-way fitting of the present invention;

FIG. 7 is an isometric view of the cage nut of the present invention;

FIG. 8 is a cross-sectional view of a cage nut of the present invention;

FIG. 9 is a schematic view of the opening and closing handle on the body member of the present invention at the proximal end;

FIG. 10 is a schematic view of the control buttons on the body member of the present invention at the distal end;

FIG. 11 is a schematic view of the control buttons on the body member of the present invention at the proximal end;

fig. 12 is a schematic diagram of an ablation procedure in accordance with the present invention.

Reference numerals illustrate:

11. an inner tube; 111. a wire lumen; 112. driving the wire cavity; 113. a guidewire lumen; 12. an outer tube; 13. a first annular elastic mesh electrode; 14. a second annular elastic mesh electrode; 15. an electrode fixing ring; 16. a protective cap; 17. a drive ring; 18. a drive wire; 19. a middle tube; 21. a three-way joint member; 211. a first interface; 212. a second interface; 213. a third interface; 214. a sealing plug; 215. a lock nut; 2151. a top block; 22. a connecting rod; 23. a body member; 231. a chute; 232. a wire port; 233. a guide port; 24. an opening/closing handle; 25. a control button; 26. a wire; 3. a target channel.

Detailed Description

The invention is described in further detail below with reference to the drawings and the specific examples. The advantages and features of the present invention will become more apparent from the following description. It is noted that the drawings are in a very simplified form and utilize non-precise ratios, and are intended to facilitate a convenient, clear, description of the embodiments of the invention.

It should be noted that all directional indicators (such as up, down, left, right, front, and rear … …) in the embodiments of the present invention are merely used to explain the relative positional relationship, movement, etc. between the components in a particular posture (as shown in the drawings), and if the particular posture is changed, the directional indicator is changed accordingly. The distal end in the embodiments of the present invention refers to the end that is distal to the operator and the proximal end refers to the end that is proximal to the operator.

Example 1

1-12, the core of the present invention is to provide a steep pulse ablation catheter for ablating target tissues in a target channel 3, especially for ablating various lumen lesion tissues (such as lesions) of different parts of a human body, such as lesions of the trachea, bronchi, intestinal tracts (such as large intestine, small intestine, duodenum, etc.), biliary tracts, blood vessels, etc.; also for example, can be used for the ablation of related lesions such as biliary tract stenosis, bronchitis, emphysema, bronchial gland hyperplasia hypertrophy, atrial fibrillation, local hyperplasia tumor and the like.

The steep pulse ablation catheter can ablate focuses in bronchus of a human body, and can adopt a passage which enters the lung of the human body, namely the upper respiratory tract trachea of the human body, unlike surgical excision and surgical ablation (such as microwaves and radio frequency) operation, so that pneumothorax can not be formed, and complications such as needle tract burn, hemoptysis, hydrothorax, pneumonia and the like can not be caused.

The steep pulse ablation catheter of the invention comprises an introduction unit, an energy application unit, a first retraction assembly and a second retraction assembly, the energy application unit being arranged on the introduction unit, the introduction unit being for bringing the energy application unit into or out of the target channel 3, the energy application unit being for applying energy to the target tissue for ablating thereof.

The introduction unit includes an inner introduction member and an outer introduction member which are disposed so as to be nested with each other, and the outer introduction member is movable relative to the inner introduction member, but the inner introduction member and the outer introduction member are not particularly limited in this embodiment, but the inner introduction member is preferably the inner tube 11 in this embodiment, and the outer introduction member is preferably the outer tube 12. The outer tube 12 has at least a first position at the distal end and a second position at the proximal end when moved relative to the inner tube 11.

The energy applying unit includes at least one pair of energy applying elastic elements, each pair of energy applying elastic elements includes a positive energy applying elastic element connected to the positive electrode and a negative energy applying elastic element connected to the negative electrode, and the pair of energy applying elastic elements are not limited in this embodiment, and are provided in this embodiment to connect the positive electrode and the negative electrode, respectively. The positive energy application elastic elements and the negative energy application elastic elements are alternately arranged on the inner tube 11 in sequence at intervals along the length direction of the inner tube 11.

The energy application elastic element has a flexible and deformable characteristic, and the specific implementation of the energy application elastic element is not particularly limited in this embodiment, but preferably, the energy application elastic element in this embodiment is an annular elastic mesh electrode, and the annular elastic mesh electrode is in a hollow structure and is made of an elastically deformed metal material, such as spring steel, nickel-titanium alloy, and the like, and is specifically formed by braiding a wire-shaped metal material, such as nickel-titanium alloy wire. The annular elastic mesh electrode can realize ablation by high-voltage discharge and non-contact high-voltage electric field energy covering target tissues without being required to be abutted against the target tissues like radio frequency ablation. The high-voltage electric field has selectivity, and electroporation is carried out on the cell membrane of the lipid bilayer structure cell to induce apoptosis of the lipid bilayer structure cell, so that the human lumen structure is not damaged. The steep pulse ablation catheter directly acts on pathological tissues of the trachea and biliary tract of the lung, and meanwhile, high temperature cannot be generated due to steep pulse ablation, so that the tube wall cannot be carbonized or collapsed.

The hollow structure of the annular elastic reticular electrode can enable tissue fluid in the target channel 3 such as a human trachea to contact the annular elastic reticular electrode, and the tissue fluid can flow into the annular elastic reticular electrode, so that the ablation of target tissues is better realized. In addition, the hollow structure can facilitate the positioning of the steep pulse ablation catheter, so that the target tissue can be observed by means of an endoscope, X-rays and the like.

An annular elastic mesh electrode surrounds and is wrapped around the inner tube 11, the annular elastic mesh electrode being configured to elastically expand into an operative configuration by an elastic force, to elastically contract into a delivery configuration by the action of the first contraction assembly or the second contraction assembly, the annular elastic mesh electrode being configured to conform to and support the target passageway 3 in the operative configuration to achieve positioning in the target passageway 3 such that it is relatively stationary with respect to the target tissue, thereby enhancing the effect of ablating the target tissue.

For example, the annular elastic mesh electrode can be self-adaptively attached to the lumen structures of the lung trachea, bronchus and the like, so that when the annular elastic mesh electrode is arranged on the periphery of the focus trachea, the annular elastic mesh electrode can still keep relative static with the focus when breathing, the positioning of the catheter is facilitated, and the annular elastic mesh electrode can be attached to the pathological tissue in the trachea after being expanded.

When the introducing unit drives the annular elastic mesh electrode to enter the target channel 3 and the outer tube 12 is positioned at the first position, the first contraction component is the outer tube 12, the outer tube 12 restrains the two annular elastic mesh electrodes between the outer tube 12 and the inner tube 11 to form a conveying configuration, namely, the outer tube 12 is sleeved on the annular elastic mesh electrode, and the annular elastic mesh electrode is completely attached to the inner tube 11 at the moment, so that the occupied area of the steep pulse ablation catheter when the annular elastic mesh electrode is in a contracted state can be effectively reduced, and the steep pulse ablation catheter can smoothly move in the target channel 3; when the outer tube 12 is in the second position, the outer tube 12 removes the constraint of the annular elastic mesh electrode, i.e., the outer tube 12 leaves the annular elastic mesh electrode, which is changed to the working configuration by the elastic force.

When the introducing unit drives the annular elastic mesh electrode to leave the target channel 3, the annular elastic mesh electrode is contracted from the working configuration to the delivery configuration by the outer tube 12 or the second contraction assembly.

Specifically, one end of the annular elastic mesh electrode is a fixed end and is in a radial shrinkage state and is fixedly connected with the inner tube 11, the other end of the annular elastic mesh electrode is an open end, the open end of the annular elastic mesh electrode is in a radial expansion state when the annular elastic mesh electrode is in a working configuration, the adjacent annular elastic mesh electrodes are symmetrically arranged, the annular elastic mesh electrode positioned at the far end in the embodiment is a first annular elastic mesh electrode 13, the annular elastic mesh electrode positioned at the near end is a second annular elastic mesh electrode 14, the first annular elastic mesh electrode 13 is connected with the positive electrode, the second annular elastic mesh electrode 14 is connected with the negative electrode, or the first annular elastic mesh electrode 13 is connected with the negative electrode, and the second annular elastic mesh electrode 14 is connected with the positive electrode. The open ends of the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 are disposed opposite to each other. The first annular elastic reticular electrode 13 and the second annular elastic reticular electrode 14 are symmetrically arranged, so that the formed high-voltage pulse electric field is more uniform, and the ablation effect is better.

Further, the fixed ends of the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 are provided with an electrode fixing ring 15, the electrode fixing ring 15 is sleeved and fixedly connected with the inner tube 11, the fixed end of the annular elastic mesh electrode is fixedly connected with the electrode fixing ring 15, and the electrode fixing ring 15 can be fixedly connected with the inner tube 11 in a welding, clamping, bonding, heat welding, threaded connection or integrated forming mode.

When the leading-in unit drives the second annular elastic mesh electrode 14 to leave the target channel 3, the second annular elastic mesh electrode 14 is driven by the far end of the outer tube 12 to change from a working configuration to a conveying configuration, the specific outer tube 12 moves towards the far end, is sleeved on the electrode fixing ring 15 through the fixing end of the second annular elastic mesh electrode 14, and then the second annular elastic mesh electrode 14 is gradually compressed and sleeved on the electrode fixing ring, so that the second annular elastic mesh electrode 14 is changed into the conveying configuration and restrained between the outer tube 12 and the inner tube 11, and the control mode is simple and convenient and the stability is high.

When the leading-in unit drives the first annular elastic mesh electrode 13 to leave the target channel 3, the first annular elastic mesh electrode 13 is driven by the second contraction assembly to change from the working configuration to the delivery configuration, and then the outer tube 12 is sleeved on the first annular elastic mesh electrode 13 through the open end of the first annular elastic mesh electrode 13 to restrain the first annular elastic mesh electrode 13 between the outer tube 12 and the inner tube 11.

The driving unit comprises a driving element and a force transmission element, wherein the driving element surrounds and is coated on the inner tube 11, and is positioned on one side of the annular elastic net electrode with the open end facing the proximal end facing the distal end, the force transmission element extends from the proximal end of the inner tube 11 to the driving element and is fixedly connected with the driving element, the driving element is driven by the force transmission element to move towards the proximal end, and the driving element is sleeved on the driving element through the fixed end of the annular elastic net electrode and drives the driving element to change into a conveying configuration.

Specifically, the inner tube 11 is hollow, the force transmission element penetrates through the inner tube 11, the driving element is a driving ring 17, the driving ring 17 is sleeved on the inner tube 11 and is positioned on one side of the first annular elastic mesh electrode 13 facing the distal end, the force transmission element is a driving wire 18, the driving wire 18 penetrates through the inner tube 11 and extends to the operation side of the proximal end, and the distal end of the driving wire 18 is fixedly connected with the driving ring 17 by penetrating out of the tube wall of the inner tube 11 near the first annular elastic mesh electrode 13. Pulling on the drive wire 18 moves the drive ring 17 proximally to retract the first annular elastic mesh electrode 13 into a delivery configuration. When the driving ring 17 abuts against the electrode fixing ring 15 of the first annular elastic mesh electrode 13, the first annular elastic mesh electrode 13 is in an expanded state.

The driving ring 17 is made of metal material (such as 314/316 stainless steel) or self-lubricating high-strength engineering plastic, the driving wire 18 is made of high-strength high-toughness high-molecular material (or other metal wires with insulated outer surfaces), the distal end of the driving wire 18 is fixedly connected with the driving ring 17 in a knotting manner, and of course, fixing manners such as welding, clamping, bonding and the like can also be adopted. The dimensions of the driving ring 17 and the electrode fixing ring 15 are consistent, the electrode fixing ring 15 is made of the same material as the driving ring 17, and the dimensions of the driving ring 17 and the electrode fixing ring 15 are slightly larger than the minimum diameter of the first annular elastic net electrode 13 when contracting and smaller than the inner diameter of the outer tube 12, so that the electrode fixing ring can be completely contained in the outer tube 12.

The distal end of the inner tube 11 is provided with a protective cap 16, the protective cap 16 is fixedly abutted against the electrode fixing ring 15 of the first annular elastic mesh electrode 13, and the protective cap 16 is made of a flexible material, such as a soft rubber material, so that the inner tube 11 is prevented from damaging the wall of the target channel 3 when entering the target channel.

Further, the sliding type inner tube comprises a middle tube 19, the middle tube 19 is at least partially sleeved on the inner tube 11, the outer tube 12 is sleeved on the middle tube 19, and the middle tube 19 is used for filling a gap between the inner tube 11 and the outer tube 12 so that the outer tube 12 can stably slide. The outer tube 12 may be movable relative to the middle tube 19, or the outer tube 12 may be movable relative to the inner tube 11. The inner tube 11, the middle tube 19 and the outer tube 12 can be made of insulating materials, and the manufactured inner tube 11, middle tube 19 and outer tube 12 have certain elasticity, can be bent under stress and are not easy to bend and deform. The inner tube 11, the middle tube 19, and the outer tube 12 are made of a polymer insulating material in this embodiment, which includes, but is not limited to, one or more combinations of Polyurethane (PU), polyethylene (PE), polyether block Polyamide (PEBAX), PTFE, FEP, etc., and the materials of the inner tube 11 and the middle tube 19 and the outer tube 12 may be the same or different.

The first and second annular elastic mesh electrodes 13 and 14 may be in an elastically expanded state in a natural state, the middle and open ends of the first and second annular elastic mesh electrodes 13 and 14 are automatically expanded when they are extended out of the outer tube 12, and the diameters of the first and second annular elastic mesh electrodes 13 and 14 are larger than the diameter of the outer tube 12 when they are expanded, and the diameters of the middle and open ends thereof are smaller than the diameter of the outer tube 12 and larger than the diameter of the inner tube 11 in a contracted state. In some embodiments, the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 may have diameters of 0.3mm to 3mm (e.g., 0.3mm, 0.5mm, 0.8mm, 1mm, 2mm, 3mm, etc.) when they contract. The diameter of the inner wall of the outer tube 12 may be slightly larger than the diameter of the first and second annular elastic mesh electrodes 13 and 14 when they contract. When the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 are expanded, the maximum diameter after expansion may be 5 to 40mm (e.g., 5mm, 8mm, 15mm, 25mm, 40mm, etc.). The sizes of the inner tube 11 and the outer tube 12, and the sizes of the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 may be adaptively adjusted according to the ablation site, the type of lesion target tissue, the age of the patient, and the like, which is not limited in this embodiment.

Also included is a flexible guide member extending through the inner tube 11 to a distal side of the inner tube 11 for guiding movement of the inner tube 11 and the outer tube 12 in the target pathway 3. In this embodiment, the flexible guiding element is a guide wire, so that the inner tube 11 and the outer tube 12 can be guided to move in the target channel 3, and particularly, when the target channel 3 has a curve or a bifurcation, the inner tube 11 and the outer tube 12 can be smoothly guided to the bifurcation by the guide wire, specifically, the guide wire can be firstly extended to enter the bifurcation, and then the inner tube 11 and the outer tube 12 can be smoothly guided to the bifurcation.

Preferably, three cavities, namely a wire cavity 111, a driving wire cavity 112 and a wire cavity 113 are arranged in the inner tube 11, a wire 26 is penetrated in the wire cavity 111, the wire 26 is electrically connected with the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14, the wire 26 is connected with a device for outputting energy to output high-voltage steep pulse energy to be supplied to the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14, and the driving wire cavity 112 and the wire cavity 113 are respectively used for accommodating the driving wire 18 and the guide wire.

Example 2

Referring to fig. 1 to 12, based on embodiment 1, the present invention further provides a steep pulse ablation device for ablating target tissue in a target pathway 3, comprising a steep pulse ablation catheter of embodiment 1 and a control unit provided at a proximal end of the steep pulse ablation catheter for driving the steep pulse ablation catheter into the target pathway 3.

The control unit comprises a first control element and a second control element, the first control element is movably connected with the second control element, the first control element can move towards the proximal end or the distal end relative to the second control element, a locking component is further arranged between the first control element and the second control element, and the locking component can lock the first control element and the second control element to fix the relative positions of the first control element and the second control element; the first control element is connected with the outer tube 12, the second control element is connected with the inner tube 11, and the outer tube 12 can be driven to move relative to the inner tube 11 when the first control element moves relative to the second control element.

When the locking component locks the first control element and the second control element, the first control element and the second control element can drive the outer tube 12 and the inner tube 11 to move in the target channel 3 simultaneously so as to realize the delivery of the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 to the target tissue; when the locking assembly releases the locking between the first control element and the second control element, the outer tube 12 can be driven to move proximally relative to the inner tube 11 by the proximal movement of the first control element relative to the second control element, so that the outer tube 12 releases the constraint on the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 to change to the working configuration.

Specifically, the first control element is a three-way joint piece 21, and the three-way joint piece 21 is hollow and provided with a first interface 211, a second interface 212 and a third interface 213 which are communicated with the interior of the three-way joint piece 21.

The first interface 211 is disposed at the distal end of the three-way connector 21, and the first interface 211 is fixedly connected to the proximal end of the outer tube 12, specifically, the inner portion of the outer tube 12 is hollow and is communicated with the inner portion of the three-way connector 21 through the first interface 211 by means of welding, clamping, bonding or other fixing methods. The second interface 212 is disposed at one side of the three-way joint member 21, and the second interface 212 is used for injecting a liquid medicine into the three-way joint member 21 and the outer tube 12, the liquid medicine enters the outer tube 12 through a gap between the outer tube 12 and the inner tube 11 and enters the positions of the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 in the target channel 3 from the distal end of the outer tube 12, and the functionality is greatly enhanced by injecting the liquid medicine into the target channel 3, for example, a developer, a physiological saline and the like can be injected into the target channel 3, the developer can enhance the ultrasonic detectability, the physiological saline can enhance the conductivity around the energy-applying elastic element, and the ablation effect is improved. The third interface 213 is disposed at the proximal end of the three-way joint member 21, and the second control element is disposed through the third interface 213 and disposed in the three-way joint member 21 and connected to the inner tube 11 through the first interface 211.

The second control element comprises a hollow connecting piece and a main body piece 23, the connecting piece is movably connected with the three-way joint piece 21, the connecting piece is a metal connecting rod 22 in the embodiment, the connecting rod 22 is hollow, the connecting rod 22 is arranged in the three-way joint piece 21 in a penetrating manner through a third interface 213 and is communicated with the inner tube 11 through a first interface 211, the proximal end of the connecting rod 22 is communicated with the main body piece 23, and a wire cavity 111, a driving wire cavity 112 and a wire cavity 113 are also arranged in the connecting rod 22 corresponding to the inner tube 11 and are respectively used for accommodating a wire 26, a driving wire 18 and a wire.

The third interface 213 department of tee bend joint piece 21 is located to the locking subassembly, and the locking subassembly includes sealing plug 214 and lock nut 215, and sealing plug 214 can be made by the silica gel material, and sealing plug 214 locates in the tee bend joint piece 21 and with the inner wall sealing connection of tee bend joint piece 21, and the distal end of sealing plug 214 and the mutual butt of the portion of leaning on in the tee bend joint piece 21, the portion of leaning on specifically is the step of leaning on in the tee bend joint piece 21, is equipped with the through-hole in the sealing plug 214, and connecting rod 22 wears to locate the through-hole. The lock nut 215 is in threaded connection with the third interface 213, an extrusion part is arranged in the lock nut 215, the extrusion part is specifically a top block 2151, and the top block 2151 abuts against the proximal end of the sealing plug 214 through the threaded locking force of the lock nut 215 and compresses the proximal end of the sealing plug 214, so that the sealing plug 214 and the connecting rod 22 are tightly sealed, and the connecting rod 22 and the three-way connector piece 21 are mutually locked through the tightening force, that is, the third interface 213 can be sealed through the sealing plug 214 and the lock nut 215, so that the liquid medicine does not flow back, and the locking of the connecting rod 22 can be realized.

The driving wire 18 is arranged in the inner tube 11, the connecting rod 22 and the main body piece 23 in a penetrating way, the main body piece 23 is provided with a chute 231 extending from the proximal end to the distal end, the chute 231 is connected with a control piece in a sliding way, the control piece is connected with the driving wire 18, and the driving wire 18 and the driving ring 17 are driven to move towards the proximal end through the sliding control piece.

Specific forms of the control member the present embodiment is not particularly limited, and referring to fig. 4 and 10, the control member may be an opening and closing handle 24 or a control button 25.

A wire 26 opening 232 is arranged on one side of the main body member 23, and the wire 26 enters the main body member 23 through the wire 26 opening 232 and is electrically connected with the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 through the connecting rod 22 and the inner tube 11 in sequence. The proximal end of the body member 23 is provided with a guide opening 233, and a guide wire enters the body member 23 through the guide opening 233 and passes through the connecting rod 22 into the inner tube 11.

The working process of the invention is further described below:

referring to fig. 12, in an initial state, the outer tube 12 is sleeved on the first annular elastic mesh electrode 13, the second annular elastic mesh electrode 14 and the driving ring 17, so that the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 are in an elastically contracted conveying configuration, at this time, the distal end of the outer tube 12 is abutted against the protective cap 16, the inner tube 11 and the outer tube 12 are driven to enter the target channel 3 by holding the three-way joint piece 21 and the main body piece 23 by hands, and enter the main body piece 23 from the guiding opening 233 of the main body piece 23 when entering, and pass through the inner tube 11 through the connecting rod 22 and the inner tube 11, and guide the inner tube 11 and the outer tube 12 to a target tissue of the target channel 3 by using a guide wire.

When the distal end of the protective cap 16 extends into the target tissue of the target passageway 3, the operator can unscrew the lock nut 215, unlock the three-way connector piece 21 from the connecting rod 22, then push the three-way connector piece 21 proximally, hold the connecting rod 22 and the main body piece 23 stationary, and move the three-way connector piece 21 to drive the outer tube 12 proximally relative to the inner tube 11, thereby sequentially releasing the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 from the outer tube 12, expanding the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 at the designated positions to form an operating configuration, and the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 are matched with the passageway wall of the target passageway 3 to achieve positioning in the target passageway 3.

After the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 are expanded, the lock nut 215 is locked, then the first annular elastic mesh electrode 13 and the second annular elastic mesh electrode 14 are respectively connected with positive and negative voltages, a high-voltage pulse electric field is formed in a target tissue area for ablation, and in the process, the liquid medicine can be injected into the target channel 3 through the second interface 212 of the three-way connector piece 21.

After ablation, the opening and closing handle 24 is controlled to slide to the proximal end on the main body piece 23, the opening and closing handle 24 drives the driving ring 17 to move to the proximal section through the driving wire 18, and the driving wire 18 compresses the first annular elastic mesh electrode 13 to enable the first annular elastic mesh electrode to be changed into a conveying configuration again. Then unscrewing the lock nut 215 again, pushing the outer tube 12 distally through the three-way joint piece 21, compressing the second annular elastic mesh electrode 14 by the outer tube 12 to change into the delivery configuration again and sleeving the second annular elastic mesh electrode, continuing moving the outer tube 12 distally to sleeve the first annular elastic mesh electrode 13, finally screwing the lock nut 215, and pushing out the inner tube 11 and the outer tube 12.

The invention is completely attached to the inner tube 11 when the first annular elastic reticular electrode 13 and the second annular elastic reticular electrode 14 shrink, thereby effectively reducing the occupied area of the first annular elastic reticular electrode 13 and the second annular elastic reticular electrode 14 in a shrinking state in a steep pulse ablation catheter, smoothly moving in the target channel 3, adaptively adjusting and attaching to the lumen of human tissue when the first annular elastic reticular electrode 13 and the second annular elastic reticular electrode 14 expand, and ensuring that the electrode position of the steep pulse ablation catheter corresponds to and keeps relatively static with the lesion tissue, thereby enhancing the effect of ablating the lesion tissue. Meanwhile, the steep pulse ablation catheter and the steep pulse ablation device are reliable in structure, high in realizability, convenient to operate, not easy to adhere and better in ablation effect.

The embodiments of the present invention have been described in detail with reference to the drawings, but the present invention is not limited to the above embodiments. Even if various changes are made to the present invention, it is within the scope of the appended claims and their equivalents to fall within the scope of the invention.

Claims (15)

1. A steep pulse ablation catheter for ablating target tissue in a target pathway, comprising an introduction unit, an energy application unit, a first retraction assembly and a second retraction assembly, wherein the energy application unit is arranged on the introduction unit and is used for driving the energy application unit to enter or leave the target pathway, and the energy application unit is used for applying energy to the target tissue to ablate the target tissue;

the introducing unit comprises an inner introducing part and an outer introducing part which are mutually nested, the outer introducing part can move relative to the inner introducing part, and the outer introducing part at least has a first position at a far end and a second position at a near end when moving relative to the inner introducing part;

the energy applying unit comprises at least one pair of energy applying elastic elements, each pair of the energy applying elastic elements comprises a positive energy applying elastic element connected with a positive electrode and a negative energy applying elastic element connected with a negative electrode, the positive energy applying elastic element and the negative energy applying elastic element of each pair of the energy applying elastic elements are alternately arranged on the inner guide piece at intervals along the length direction of the inner guide piece in turn, and the positive energy applying elastic element and the negative energy applying elastic element are configured to be elastically expanded into an operating configuration through elastic force and elastically contracted into a conveying configuration through the action of the first contraction assembly or the second contraction assembly; the positive energy applying resilient element and the negative energy applying resilient element are configured to conform to and support the target passageway in the operative configuration to achieve positioning in the target passageway such that it is relatively stationary with respect to the target tissue;

The first contraction assembly is the outer introduction member which constrains the positive energy application elastic element and the negative energy application elastic element into the delivery configuration when the introduction unit drives the energy application unit to enter the target channel and the outer introduction member is in the first position state; when the outer introducing member is in the second position state, the outer introducing member releases the positive energy applying elastic element and the negative energy applying elastic element to elastically expand into the working configuration by elastic force;

the introduction unit causes the positive energy application elastic element and the negative energy application elastic element to retract into the delivery configuration through the first retraction assembly or the second retraction assembly as the energy application unit is moved away from the target pathway.

2. The steep pulse ablation catheter according to claim 1, wherein one end of the positive energy applying elastic element and one end of the negative energy applying elastic element are fixed ends and are in a radially contracted state and are fixedly connected with the inner lead-in member, and the other end is an open end, wherein the open end is in a radially expanded state when in the working configuration, and the adjacent positive energy applying elastic element and the adjacent negative energy applying elastic element are symmetrically arranged;

When the introducing unit drives the energy applying unit to leave the target channel, the outer introducing piece drives the positive energy applying elastic element and the negative energy applying elastic element with the open ends facing to the distal end to change into the conveying configuration, and the distal end of the outer introducing piece is sleeved into the positive energy applying elastic element and the negative energy applying elastic element through the fixed end and applies force to the positive energy applying elastic element and the negative energy applying elastic element to enable the positive energy applying elastic element and the negative energy applying elastic element to elastically shrink into the conveying configuration; the outer introducer is constrained between the outer introducer and the inner introducer via the open end after the positive and negative energy-applying elastic elements are driven proximally by the second retraction assembly to change to the delivery configuration.

3. A steep pulse ablation catheter according to claim 2, wherein the second retraction assembly comprises a drive element surrounding and surrounding the inner introducer on the distal side of the positive energy applying resilient element and the negative energy applying resilient element, and a force transfer element extending from the proximal end of the inner introducer to and fixedly attached to the drive element for driving the drive element towards the proximal end, the drive element being sleeved over the fixed end of the energy applying resilient element and being biased to drive the change to the delivery configuration.

4. A steep pulse ablation catheter according to claim 3, wherein the drive element is a drive ring, the drive ring is sleeved on the inner lead-in member, the force transfer element is a drive wire, the inner lead-in member is hollow, and the drive wire is threaded into the inner lead-in member;

the driving wire penetrates through the inner guide piece and is fixedly connected with the driving ring when extending from the proximal end to a position close to the driving ring, and the driving wire is pulled towards the proximal end to drive the driving ring to move towards the proximal end so as to drive the positive energy application elastic element and the negative energy application elastic element to change into the conveying configuration.

5. The steep pulse ablation catheter according to claim 1, wherein the inner introducer is an inner tube and the outer introducer is an outer tube, the outer tube being sleeved over the inner tube with a gap between the outer tube and the inner tube accommodating the positive and negative energy applying resilient elements.

6. The steep pulse ablation catheter according to claim 1, wherein the positive energy applying resilient element and the negative energy applying resilient element are annular resilient mesh electrodes.

7. The steep pulse ablation catheter according to claim 1, comprising a flexible guiding element penetrating the inner introducer and extending to a distally facing side of the inner introducer, the flexible guiding element being adapted to guide the movement of the inner introducer and the outer introducer in the target pathway.

8. The steep pulse ablation catheter according to claim 7, wherein the flexible guide element is a guide wire extending from a proximal end to a distal end and penetrating the distal end of the inner guide member into the target channel, the guide wire being curvedly disposed along a target path in the target channel, the inner guide member and the outer guide member being movable along the guide wire.

9. The steep pulse ablation device is used for ablating target tissues in a target channel and is characterized by comprising a steep pulse ablation catheter and a control unit, wherein the control unit is arranged at the proximal end of the steep pulse ablation catheter and is used for driving the steep pulse ablation catheter to enter the target channel;

the steep pulse ablation catheter comprises an introduction unit, an energy application unit, a first contraction assembly and a second contraction assembly, wherein the energy application unit is arranged on the introduction unit and is used for driving the energy application unit to enter or leave the target channel, and the energy application unit is used for applying energy to the target tissue so as to ablate the target tissue;

The introducing unit comprises an inner introducing part and an outer introducing part which are mutually nested, the outer introducing part can move relative to the inner introducing part, and the outer introducing part at least has a first position at a far end and a second position at a near end when moving relative to the inner introducing part;

the energy applying unit comprises at least one pair of energy applying elastic elements, each pair of the energy applying elastic elements comprises a positive energy applying elastic element connected with a positive electrode and a negative energy applying elastic element connected with a negative electrode, the positive energy applying elastic element and the negative energy applying elastic element of each pair of the energy applying elastic elements are alternately arranged on the inner guide piece at intervals along the length direction of the inner guide piece in turn, and the positive energy applying elastic element and the negative energy applying elastic element are configured to be elastically expanded into an operating configuration through elastic force and elastically contracted into a conveying configuration through the action of the first contraction assembly or the second contraction assembly; the positive energy applying resilient element and the negative energy applying resilient element are configured to conform to and support the target passageway in the operative configuration to achieve positioning in the target passageway such that it is relatively stationary with respect to the target tissue;

The first contraction assembly is the outer introduction member which constrains the positive energy application elastic element and the negative energy application elastic element into the delivery configuration when the introduction unit drives the energy application unit to enter the target channel and the outer introduction member is in the first position state; when the outer introducing member is in the second position state, the outer introducing member releases the positive energy applying elastic element and the negative energy applying elastic element to elastically expand into the working configuration by elastic force;

the introduction unit drives the energy application unit to leave the target channel, and the positive energy application elastic element and the negative energy application elastic element are contracted into the conveying configuration through the first contraction assembly or the second contraction assembly;

the control unit comprises a first control element and a second control element, the first control element is movably connected with the second control element, the first control element can move towards the near end or the far end relative to the second control element, a locking component is further arranged between the first control element and the second control element, and the locking component can lock the first control element and the second control element to fix the relative positions of the first control element and the second control element; the first control element is connected with the outer guide-in part, the second control element is connected with the inner guide-in part, and the first control element can drive the outer guide-in part to move relative to the inner guide-in part when moving relative to the second control element.

10. The steep pulse ablation apparatus according to claim 9, wherein the first control element is a three-way fitting, which is hollow inside and provided with a first port, a second port and a third port communicating with the inside thereof;

the first interface is arranged at the far end of the three-way connector, the first interface is connected with the near end of the outer guide-in part, and the inner part of the outer guide-in part is hollow and is communicated with the three-way connector through the first interface;

the second interface is used for injecting liquid medicine into the three-way connector piece and the outer guide piece, and the liquid medicine enters the energy applying unit in the target channel through the distal end of the outer guide piece;

the third interface is arranged at the proximal end of the three-way joint piece, and the second control element is arranged in the three-way joint piece in a penetrating way through the third interface and is connected with the inner guide-in piece through the first interface.

11. The steep pulse ablation device according to claim 10, wherein the locking assembly is provided at the third interface of the three way fitting, the locking assembly comprising a sealing plug and a locking nut;

the sealing plug is arranged in the three-way joint piece and is in sealing connection with the inner wall of the three-way joint piece, and the distal end of the sealing plug is mutually abutted with the abutting part in the three-way joint piece; a through hole is formed in the sealing plug, and the second control element penetrates through the through hole;

The lock nut is in threaded connection with the third interface, an extrusion part is arranged in the lock nut, the extrusion part is in butt joint with the proximal end of the sealing plug through the threaded locking force of the lock nut and compresses the proximal end of the sealing plug, so that the sealing plug and the second control element are tightly sealed in a tensioning manner, and the second control element and the three-way connector piece are mutually locked through the tensioning force.

12. The steep pulse ablation device according to claim 9, wherein the inner lead-in member is hollow and the second control element comprises a hollow connector member and a body member, the connector member being movably connected to the first control element, the connector member having a distal end in communication with the inner lead-in member and a proximal end in communication with the body member.

13. The steep pulse ablation device according to claim 12, wherein one end of the positive energy applying elastic element and one end of the negative energy applying elastic element are fixed ends and are in a radially contracted state and are fixedly connected with the inner lead-in member, and the other end is an open end, wherein the open end is in a radially expanded state in the working configuration, and the adjacent positive energy applying elastic element and the adjacent negative energy applying elastic element are symmetrically arranged;

When the introducing unit drives the energy applying unit to leave the target channel, the outer introducing piece drives the positive energy applying elastic element and the negative energy applying elastic element with the open ends facing to the distal end to change into the conveying configuration, and the distal end of the outer introducing piece is sleeved into the positive energy applying elastic element and the negative energy applying elastic element through the fixed end and applies force to the positive energy applying elastic element and the negative energy applying elastic element to enable the positive energy applying elastic element and the negative energy applying elastic element to elastically shrink into the conveying configuration; the outer introducer being constrained between the outer introducer and the inner introducer via the open end after the positive and negative energy-applying elastic elements, driven proximally by the second retraction assembly, change to the delivery configuration;

the second contraction assembly comprises a driving element and a force transmission element, wherein the driving element surrounds and is coated on the inner introduction piece and is positioned on one side of the positive energy application elastic element and one side of the negative energy application elastic element, which are oriented towards the distal end, the force transmission element extends from the proximal end of the inner introduction piece to the driving element and is fixedly connected with the driving element, the driving element is driven by the force transmission element to move towards the proximal end, and the driving element is sleeved on the driving element through the fixed end of the energy application elastic element and applies force to drive the driving element to change into the conveying configuration;

The force transfer element is arranged in the inner guide-in part, the connecting part and the main body part in a penetrating way, the main body part is connected with a control part in a sliding way, the control part is connected with the force transfer element, and the control part is slid to drive the force transfer element and the driving element to move towards the near end.

14. The steep pulse ablation device according to claim 12, wherein the body member is provided with a wire opening through which wires for energizing the positive energy applying elastic element and the negative energy applying elastic element enter the body member and are electrically connected to the energy applying elastic element in turn via the connecting member and the inner lead-in member.

15. The steep pulse ablation device according to claim 12, comprising a flexible guiding element penetrating the inner introducer and extending to a distally facing side of the inner introducer, the flexible guiding element being adapted to guide the movement of the inner introducer and the outer introducer in the target pathway;

the main body piece is provided with a guide opening, and the flexible guide element enters the main body piece through the guide opening and penetrates through the inner guide piece through the connecting piece.