Flexible electrode pulse ablation catheter, pulse ablation device and ablation equipment

Abstract

The invention relates to the technical field of ablation, in particular to a flexible electrode pulse ablation catheter, a pulse ablation device and ablation equipment.The ablation catheter comprises a catheter body with a far end and a near end which are oppositely arranged, and the catheter body comprises a traction structure and a conveying pipe assembly arranged on the traction structure in a sleeving mode; the electrode assembly comprises at least one connecting pipe and at least two electrodes, every two adjacent electrodes are fixedly connected through the corresponding connecting pipe, and each electrode is of a tubular structure internally provided with a cavity; one end of the traction structure penetrates through the conveying pipe assembly, then extends into the electrode assembly and is fixedly connected with one end of an electrode arranged close to the far end of the pipe body. Under the action of external force, the traction structure can drive the two opposite ends of the same electrode to move oppositely or move away from the tubular structure until the tubular structure shrinks or expands. The flexible degree of the electrode assembly can be improved, the electrode with a larger area can be attached to the focus, conveying and ablation at the large-angle position of the periphery of the focus are achieved, the ablation effect is guaranteed, and the ablation success rate is increased.

Description

Technical Field

[0001] The present application relates to the field of ablation technology, and in particular to a flexible electrode pulse ablation catheter, a pulse ablation device and an ablation equipment. Background Art

[0002] The pulse ablation device uses the principle of pulse ablation electric field, mainly applying a short and high pulse voltage between two electrodes made of special materials, so that the original membrane potential of the cell changes, and irreversible nano-scale holes are generated in the lipid bilayer of the membrane, which destroys the homeostasis of the cell and causes cell death. Moreover, this ablation method only causes cell death in a specific area, while preserving the integrity of the cell's tissue scaffold, fiber structure, etc., while the tissues adjacent to the ablation area (such as blood vessels or surrounding normal tissues) are not damaged, avoiding the "heat sink effect" of the ablation area, which is conducive to the repair of the body.

[0003] Pulse ablation devices are mainly used for the treatment of atrial fibrillation, tumors, and cardiac electrophysiological diseases. Tumor treatment includes liver cancer, lung cancer, kidney cancer, etc. Existing pulse ablation devices have many shortcomings in the treatment of lung tumors, which limits their clinical application: for example, first, at least 2 and up to 6 electrodes are required to be placed in or around the tumor, which is very time-consuming and may lead to needle placement errors. At the same time, multiple punctures have a high risk of complications such as pneumothorax and pleural effusion; second, the ablation electrodes must be placed precisely and in parallel to generate a sufficiently strong electric field. On the one hand, the angle of the electrodes may cause overcurrent at locations where the electrodes are close, resulting in unnecessary Joule heating; on the other hand, incomplete ablation may occur at locations where the electrodes are far apart. Placing electrodes in parallel in the chest is extremely challenging due to the obstruction of the ribs; third, the air in the alveoli of the lungs is an excellent insulator for electric current, which significantly affects the energy transfer between the electrodes, limits the degree of ablation of lung cancer tissue outside the electrodes, and leads to an overestimation of the ablation area, thereby reducing the ablation effect. Summary of the invention

[0004] In order to solve the above technical problems, the present application can improve the flexibility of the electrode assembly, achieve a larger area of ​​electrode and lesion contact, realize the delivery and ablation of lesions at large angles around the lesions, ensure the ablation effect, and improve the ablation success rate.

[0005] The present application provides a flexible electrode pulse ablation catheter, comprising:

[0006] A tube body having a distal end and a proximal end disposed opposite to each other, the tube body comprising a traction structure and a delivery tube assembly sleeved on the traction structure;

[0007] An electrode assembly disposed at the distal end of the tube body, the electrode assembly comprising at least one connecting tube and at least two electrodes, two adjacent electrodes being fixedly connected via the connecting tube, and the electrode being a tubular structure having a cavity inside;

[0008] One end of the traction structure passes through the delivery tube assembly and then extends into the electrode assembly, and is fixedly connected to one end of the electrode arranged near the distal end of the tube body;

[0009] Under the action of external force, the traction structure can reciprocate along the axial direction of the delivery tube assembly to drive the opposite ends of the same electrode to move toward or away from each other until the tubular structure contracts or expands.

[0010] Furthermore, the electrode satisfies at least one of the following characteristics:

[0011] The electrode is in a contracted state, and the maximum diameter of the electrode is 0.5 mm-5 mm;

[0012] The electrode is in an expanded state, and the maximum diameter of the electrode is 1.5 mm-20 mm.

[0013] Furthermore, when the electrode is in a contracted state, the cross-section of the electrode is cylindrical; when the electrode is in an expanded state, the cross-section of the electrode is elliptical.

[0014] Furthermore, the electrode assembly satisfies at least one of the following characteristics:

[0015] The distance between two adjacent electrodes is 5mm-20mm;

[0016] The length of the electrode assembly is 10 mm-40 mm.

[0017] Furthermore, the positive and negative polarities of two adjacent electrodes are opposite.

[0018] Further, the two ends of the tubular structure are respectively a first polymerization end and a second polymerization end;

[0019] The first polymer end and the second polymer end are arranged along the axial direction of the delivery tube assembly, the first polymer end is arranged close to the distal end of the tube body, and the second polymer end is arranged close to the proximal end of the tube body;

[0020] One end of the delivery tube assembly is fixedly connected to a second polymer end of an electrode disposed near the proximal end of the tube body;

[0021] One end of the traction structure passes through the delivery tube assembly and then extends into the electrode assembly, and is fixedly connected to the first aggregation end of the electrode arranged near the distal end of the tube body.

[0022] Furthermore, the electrode is a tubular structure woven from metal wires.

[0023] Furthermore, the electrode further comprises an extension section, and two ends of the extension section are fixedly connected to the first polymerization end and the second polymerization end respectively;

[0024] The extension section includes at least two first connectors, and the at least two first connectors are spaced apart around the circumference of the delivery tube assembly.

[0025] Further, when the electrode is in a compressed state, the length direction of the first connecting member is parallel to the axial direction of the delivery tube assembly, the thickness direction of the first connecting member passes through the axis of the delivery tube assembly, and the first connecting member satisfies at least one of the following characteristics:

[0026] The thickness of the first connecting member is much smaller than the width of the first connecting member;

[0027] The width of the first connecting member is much smaller than the length of the first connecting member;

[0028] The number of the first connecting members is 2-14.

[0029] Furthermore, along the first polymerizing end to the second polymerizing end, the surface slope of the first connecting member gradually increases from small to large, and then gradually decreases from large to small, so as to form an arch structure.

[0030] Furthermore, it also includes an extension section, and two ends of the extension section are fixedly connected to the first polymerization end and the second polymerization end respectively;

[0031] The extension section includes a balloon membrane and an electrode membrane arranged in sequence from the inside to the outside. The interior of the balloon membrane has a sealed cavity, which can be connected to the delivery tube assembly. Liquid can enter or move away from the sealed cavity through the delivery tube assembly to drive the balloon membrane to contract or expand.

[0032] Furthermore, the electrode membrane includes at least two second connecting members, and the at least two second connecting members are arranged at intervals around the circumference of the balloon membrane.

[0033] Furthermore, the electrode film satisfies at least one of the following characteristics:

[0034] The thickness of the electrode film is 10 μm-100 μm;

[0035] The electrode film is a multi-layer film structure.

[0036] Further, when the electrode is in a compressed state, the length direction of the second connecting member is parallel to the axial direction of the delivery tube assembly, the thickness direction of the second connecting member passes through the axis of the delivery tube assembly, and the second connecting member satisfies at least one of the following characteristics:

[0037] The thickness of the second connecting member is much smaller than the width of the second connecting member;

[0038] The width of the second connecting member is much smaller than the length of the second connecting member;

[0039] The number of the second connecting members is 2-10.

[0040] Further, the electrode assembly also includes a cap and a rigid electrode;

[0041] The first end of the cap is provided with an arc surface, and the second end of the cap is provided with a traction structure mounting position and a polymerization end mounting position;

[0042] The traction structure installation position is used to be fixedly connected to one end of the traction structure, and the polymerization end installation position is used to be fixedly connected to the first polymerization end of the electrode arranged near the distal end of the tube body;

[0043] The first end of the rigid electrode is fixedly connected to the second aggregate end of the electrode arranged near the proximal end of the tube body, and the second end of the rigid electrode is fixedly connected to the tube body.

[0044] Further, the cap member includes an end cap and an electrode ring;

[0045] The arc surface is arranged at the first end of the end cap, the electrode ring is fixedly connected to the second end of the end cap, and after the electrode ring is connected to the second end of the end cap, the polymer end mounting position is formed between the electrode ring and the end cap;

[0046] The traction structure mounting position is arranged at the second end of the end cap.

[0047] Furthermore, the hardness of the tube body gradually decreases from the proximal end of the tube body to the distal end of the tube body.

[0048] Furthermore, the tube body is made of a material with a developing function.

[0049] Furthermore, along the radial direction of the delivery pipe assembly, the delivery pipe assembly is sequentially provided with an insulating pipe, a channel pipe, an outer conduit and a stress pipe;

[0050] The first end of the outer catheter is fixedly connected to the electrode assembly, the second end of the outer catheter can be fixedly connected to the handle assembly, and the stress tube is arranged at the connection position between the outer catheter and the handle assembly;

[0051] Part of the wire electrically connected to the electrode can extend into the insulating tube, and the insulating tube is used to isolate the wire electrically connected to the adjacent electrode;

[0052] There is a gap between the inner wall of the channel tube and the outer wall of the insulating tube, and one end of the channel tube is connected to the electrode assembly so as to guide the liquid to the position of the electrode assembly through the channel tube.

[0053] Furthermore, it also includes at least one position detection device, which is arranged inside the electrode and fixedly arranged on the traction structure.

[0054] The second aspect of the present invention also protects a pulse ablation device, comprising a handle assembly and a flexible electrode pulse ablation catheter as described above;

[0055] The first end of the handle assembly can be electrically connected to an ablation mechanism that emits ablation energy;

[0056] One end of the delivery tube assembly is fixedly connected to the second end of the handle assembly, and one end of the traction structure passes through the delivery tube assembly and is drivingly connected to the handle assembly. The handle assembly can drive the traction structure to reciprocate axially relative to the delivery tube assembly along the delivery tube assembly.

[0057] Further, the handle assembly includes at least two wires, a rotating wheel mechanism and a connector assembly;

[0058] The rotating wheel mechanism is fixedly connected to one end of the traction structure, and the rotating wheel mechanism drives the traction structure to reciprocate relative to the conveying pipe assembly along the axial direction of the conveying pipe assembly under the action of external force;

[0059] The first ends of the at least two wires are electrically connected to the connector assembly, the connector assembly is located at the first end of the handle assembly, and the connector assembly is electrically connected to the ablation mechanism;

[0060] The second ends of the at least two wires are electrically connected to the at least two electrodes respectively, so that the positive and negative polarities of two adjacent electrodes are opposite.

[0061] The third aspect of the present invention also protects a pulse ablation device, comprising an ablation mechanism and the pulse ablation device as described above;

[0062] The ablation mechanism is used to provide at least one pulse group to the pulse ablation device.

[0063] Furthermore, the pulse group ensures at least one high-frequency high-voltage sub-pulse and / or one low-frequency low-voltage sub-pulse, the high-frequency high-voltage sub-pulse is a bipolar pulse, and the low-frequency low-voltage sub-pulse is a unipolar pulse or a bipolar pulse; wherein the bipolar pulse includes a positive pulse amplitude and a negative pulse amplitude.

[0064] Furthermore, the pulse group satisfies at least one of the following characteristics:

[0065] The voltage amplitude range of the bipolar pulse of the high-frequency high-voltage sub-pulse is 2000V-70000V;

[0066] The pulse width of the bipolar pulse of the high-frequency and high-voltage sub-pulse is 50ns-50000ns;

[0067] The number of bipolar pulses of the high-frequency and high-voltage sub-pulses is 1-5000;

[0068] The amplitude voltage of the unipolar pulse and the amplitude voltage of the bipolar pulse of the low-frequency and low-voltage sub-pulse are 200V-3000V;

[0069] The pulse width of the unipolar pulse and the pulse width of the bipolar pulse of the low-frequency and low-voltage sub-pulse are 10 μs-500 μs;

[0070] The number of unipolar pulses and bipolar pulses of the low-frequency and low-voltage sub-pulses is 1-5000;

[0071] The number of the pulse groups is 1-5000 groups.

[0072] Implementing the embodiments of the present application has the following beneficial effects:

[0073] The electrode assembly, traction structure and delivery tube assembly in the present application cooperate with each other to achieve synchronous contraction or expansion of at least two electrodes in the electrode assembly, ensure that the flexible electrode pulse ablation catheter can bend and expand with the bronchial cavity, flexibly adjust the electrode shape to adapt to the lesion structure, and achieve a larger area of ​​electrode and lesion contact; and the electrode assembly includes at least two electrodes arranged at intervals. Compared with the conventional non-ductile ring electrode or needle electrode structure, it can reduce the electrode stiffness, improve the electrode ductility, increase the electrode coverage area, and improve the flexibility of the electrode assembly, ensuring that the electrode assembly can enter the lesion with a larger bending angle, and the two adjacent electrodes are fixedly connected by a connecting tube to achieve synchronous contraction or expansion of the two adjacent electrodes, which can further improve the flexibility of the electrode assembly, achieve a larger area of ​​electrode and lesion contact, and achieve delivery and ablation of lesions at large angles around the lesion, ensure the ablation effect, and improve the ablation success rate. BRIEF DESCRIPTION OF THE DRAWINGS

[0074] In order to more clearly illustrate the technical solution of the present application, the following is a brief introduction to the drawings required for use in the embodiments or prior art descriptions. Obviously, the drawings described below are only some embodiments of the present application, and a person of ordinary skill in the art can obtain other drawings based on these drawings without creative work.

[0075] Figure 1 This is a structural diagram of the flexible electrode pulse ablation catheter in this embodiment;

[0076] Figure 2 is a structural diagram of the electrode assembly in a contracted state in the first embodiment;

[0077] Figure 3 is a structural diagram of the electrode assembly in the first embodiment in an unfolded state;

[0078] Figure 4 is a structural diagram of the electrode described in this embodiment;

[0079] Figure 5 is a cross-sectional view of the cap member after being connected to the electrode in this embodiment;

[0080] Figure 6 is a structural diagram of the end cap described in this embodiment;

[0081] Figure 7 is a structural diagram of the end cap, the electrode ring and the electrode after being connected in this embodiment;

[0082] Figure 8 is a structural diagram of the position detection device in this embodiment after being connected to the electrode assembly;

[0083] Fig. 9 is a structural diagram of the electrode assembly in a contracted state in the second embodiment;

[0084] Fig.10 is a structural diagram of the electrode assembly in the second embodiment in an unfolded state;

[0085] Fig.11 is a structural diagram of the electrode assembly in a contracted state in the third embodiment;

[0086] Fig.12 is a structural diagram of the electrode assembly in the unfolded state in the third embodiment;

[0087] Fig.13 is a cross-sectional view of the tube body described in this embodiment;

[0088] Fig.14 is a structural diagram of the pulse ablation device described in this embodiment;

[0089] Fig.15 A schematic diagram of a pulse electric field energy packet that can be provided by a pulse ablation device in one embodiment;

[0090] Fig.16 A schematic diagram of a pulse electric field energy packet that can be provided by the pulse ablation device in the first embodiment;

[0091] Fig.17 A schematic diagram of a pulse electric field energy packet that can be provided by a pulse ablation device in a second possible embodiment;

[0092] Fig.18 A schematic diagram of a pulse electric field energy packet that can be provided by a pulse ablation device in a third embodiment;

[0093] Fig.19 A schematic diagram of a pulse electric field energy packet that can be provided by a pulse ablation device in a fourth possible embodiment;

[0094] Fig. 20 is a structural diagram of the electrode assembly in a fourth embodiment in an unfolded state;

[0095] Fig.21 is a structural diagram of the electrode assembly in a fifth embodiment in an unfolded state;

[0096] Fig. 22 is a structural diagram of the electrode assembly in a sixth embodiment in an unfolded state;

[0097] Fig.23 It is a structural diagram of the electrode assembly in the seventh embodiment in an unfolded state.

[0098] Among them, the reference numerals in the figure correspond to:

[0099] 10-electrode assembly; 20-tube body; 30-handle assembly; 40-position detection device; 50-pulse group; 101-cap; 102-electrode; 103-connecting tube; 104-rigid electrode; 301-rotating wheel mechanism; 302-connector assembly; 501-high-frequency and high-voltage sub-pulse; 502-low-frequency and low-voltage sub-pulse; 1021-extension section; 1022-first polymerization end; 1023-second polymerization end; 201-traction structure; 202-insulating tube; 203-channel tube; 204-outer catheter; 205-stress tube; 1011-end cap; 1012-electrode ring; 1011a-end; 1011b-connecting column. DETAILED DESCRIPTION

[0100] The following will be combined with the drawings in the embodiments of the present application to clearly and completely describe the technical solutions in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, not all of the embodiments. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0101] It should be noted that the terms "first", "second", etc. in the specification and claims of the present application and the above-mentioned drawings are used to distinguish similar objects, and are not necessarily used to describe a specific order or sequence. It should be understood that the data used in this way can be interchanged where appropriate, so that the embodiments of the present application described herein can be implemented in an order other than those illustrated or described herein. In addition, the terms "including" and "having" and any variations thereof are intended to cover non-exclusive inclusions.

[0102] See attached Figure 1-23 The present embodiment provides a flexible electrode pulse ablation catheter, comprising: a tube body 20 having a distal end and a proximal end relatively arranged, the tube body 20 comprising a traction structure 201 and a delivery tube assembly sleeved on the traction structure 201; an electrode assembly 10 arranged at the distal end of the tube body 20, the electrode assembly 10 comprising at least one connecting tube 103 and at least two electrodes 102, two adjacent electrodes 102 are fixedly connected by the connecting tube 103, and the electrode 102 is a tubular structure with a cavity inside; one end of the traction structure 201 passes through the delivery tube assembly and then extends into the electrode assembly 10, and is fixedly connected to one end of the electrode 102 arranged near the distal end of the tube body 20; under the action of external force, the traction structure 201 can reciprocate along the axial direction of the delivery tube assembly to drive the opposite ends of the same electrode 102 to move toward or away from each other until the tubular structure contracts or expands.

[0103] The electrode assembly 10, the traction structure 201 and the delivery tube assembly in this embodiment cooperate with each other to achieve synchronous contraction or expansion of at least two electrodes 102 in the electrode assembly 10, ensure that the flexible electrode pulse ablation catheter can bend and expand with the bronchial cavity, flexibly adjust the shape of the electrode 102 to adapt to the lesion structure, and achieve a larger area of ​​electrode and lesion contact; and the electrode assembly 10 includes at least two electrodes 102 arranged at intervals. Compared with the conventional ring electrode or needle electrode structure without ductility, it can reduce the stiffness of the electrode 102, improve the ductility of the electrode 102, increase the electrode coverage area, and improve the flexibility of the electrode assembly 10, ensure that the electrode assembly 10 can enter the lesion with a larger bending angle, and the two adjacent electrodes 102 are fixedly connected by the connecting tube 103 to achieve synchronous contraction or expansion of the two adjacent electrodes 102, which can further improve the flexibility of the electrode assembly 10, achieve a larger area of ​​electrode 102 and lesion contact, and achieve delivery and ablation of lesions at large angles around the lesion, ensure the ablation effect, and improve the ablation success rate.

[0104] In this embodiment, the flexible electrode pulse ablation catheter is mainly used for lung tumors, especially for lung tumors with a large bending angle of the lung that are difficult to observe or difficult to enter; the flexible electrode pulse ablation catheter in the flexible electrode pulse ablation catheter is inserted into the lung diseased tissue through a bronchoscope, and the outer surfaces of at least two electrodes 102 are arranged to be in contact with the diseased tissue, so that the pulses formed between the at least two electrodes 102 can ablate the lung diseased tissue; by setting up the above flexible electrode pulse ablation catheter, the problems of the ablation catheter being difficult to bend and deform and the low coverage of the electrode 102, resulting in difficult delivery of the electrode 102 and a narrow ablation range, can be solved.

[0105] Preferably, the electrode assembly 10 includes two electrodes 102 that are spaced apart. The pulse formed between the two electrodes 102 that are spaced apart can emit pulses with a width of microns or nanoseconds to the lesioned lung tissue, so as to damage the stability of the cell membrane surface of the lesioned lung tissue, and cause multiple hydrophilic micropores to appear on the cell surface of the lesioned lung tissue, so as to destroy the homeostasis of the lesioned lung tissue cells and cause the lesioned lung tissue cells to die, thereby achieving the therapeutic effect of pulse ablation of the lesioned lung tissue.

[0106] It is understandable that different lung diseased tissue cells have different destruction thresholds. By controlling the size of the pulse energy emitted by the electrode assembly 10, the pulses emitted by at least two electrodes 102 can be accurately directed to the lesion location, and the pulse ablation treatment has tissue cell selectivity; by controlling the size of the pulse energy emitted by at least two electrodes 102 corresponding to the lung diseased tissue cells, the pulse only performs pulse ablation treatment on the lung diseased tissue cells without destroying other tissue cells.

[0107] In this embodiment, the outer diameter of the electrode 102 can be extended and deformed to increase the contact area with the lesion; the conductor part in the electrode 102 is preferably made of a material with excellent biocompatibility and corrosion resistance, such as medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver, platinum, titanium, tungsten, palladium and other materials.

[0108] In this embodiment, the electrode assembly 10 includes a connecting tube 103 and two electrodes 102, the first polymer end 1022 of the first electrode 102 is fixedly connected to the first end of the traction structure 201, the second polymer end 1023 of the first electrode 102 is fixedly connected to the first end of the connecting tube 103, the second end of the connecting tube 103 is fixedly connected to the first polymer end 1022 of the second electrode 102, the second polymer end 1023 of the second electrode 102 is fixedly connected to the first end of the conveying tube assembly, the second end of the conveying tube assembly can be fixedly connected to the shell of the handle assembly 30, and the second end of the traction structure 201 can be fixedly connected to the rotating wheel mechanism 301 of the handle assembly 30, so that the traction structure 201 can be driven by the rotating wheel mechanism 301 to reciprocate relative to the conveying tube assembly, thereby driving the first polymer end 1022 and the second polymer end 1023 of the same electrode 102 to move toward or away from each other, so as to realize the contraction or expansion of the electrode 102.

[0109] In other possible embodiments, the electrode assembly 10 includes two connecting tubes 103 and three electrodes 102. Along the axial direction of the traction structure 201, the first electrode 102, the first connecting tube 103, the second electrode 102, the second connecting tube 103 and the third electrode 102 are fixedly connected in sequence. Compared with setting two electrodes 102 at intervals, setting three electrodes 102 at intervals can further improve the ductility of the electrode assembly 10, while improving the flexibility of the electrode assembly 10, achieving a larger area of ​​the electrode 102 in contact with the lesion, achieving delivery and ablation of lesions at large angles around the lesion, and ensuring the ablation effect.

[0110] In other possible embodiments, the electrode assembly 10 includes three connecting tubes 103 and four electrodes 102. Along the axial direction of the traction structure 201, the first electrode 102, the first connecting tube 103, the second electrode 102, the second connecting tube 103, the third electrode 102, the third connecting tube 103 and the fourth electrode 102 are fixedly connected in sequence. Compared with the three electrodes 102 arranged at intervals, the four electrodes 102 arranged at intervals can further improve the ductility of the electrode assembly 10, and at the same time improve the flexibility of the electrode assembly 10, so as to achieve a larger area of ​​the electrode 102 in contact with the lesion, realize the delivery and ablation of lesions at large angles around the lesion, and ensure the ablation effect.

[0111] In some possible embodiments, the electrode 102 satisfies at least one of the following characteristics: when the electrode 102 is in a contracted state, the maximum diameter of the electrode 102 is 0.5mm-5mm; when the electrode 102 is in an expanded state, the maximum diameter of the electrode 102 is 1.5mm-20mm. By setting the relevant dimensions of the electrode within the above range, it can be ensured that the electrode 102 is easy to move in the bronchus, and the contact area between the electrode 102 and the bronchus can be ensured, so that the maximum area of ​​the electrode 102 can be attached to the lesion, and a larger radial ablation range can be achieved, thereby ensuring the ablation effect.

[0112] In this embodiment, the electrode 102 is in a contracted state, and the maximum diameter of the electrode 102 is 0.5mm-2mm, 0.5mm-5mm, 1.0mm-2.0mm, 1.5mm-2.0mm, 1.0mm-3mm, 2.0mm-2.6mm, 2.3mm-2.6mm, 2.5mm-3.0mm, 2mm-5mm or 3mm-5mm, etc.; the electrode 102 is in an expanded state, and the maximum diameter of the electrode 102 is 1.5mm-5mm, 1.5mm-8mm, 1.5mm-20mm, 4mm-6mm, 5mm-10mm, 6mm-10mm, 8mm-10mm, 10mm-12mm, 10mm-15mm or 18mm-20mm, etc.

[0113] In some possible embodiments, the electrode 102 is in a contracted state, and the cross-section of the electrode 102 is cylindrical; the electrode 102 is in an expanded state, and the cross-section of the electrode 102 is elliptical. Such a configuration can ensure that the volume of the electrode 102 is as small as possible during transportation, and the shape is a cylindrical structure that is easy to transport, thereby ensuring the transportation rate; at the same time, when the electrode 102 is in an expanded state, the cross-section of the electrode 102 is elliptical, which can increase the contact area between the electrode 102 and the lesion, thereby ensuring the ablation effect.

[0114] In this embodiment, the outer surface of the electrode 102 is a conductive surface. During the ablation process, the traction structure 201 drives the electrode 102 to contract or expand, and the traction structure 201 changes the axial distance of the extension segment 1021, thereby adjusting the diameter of the extension segment 1021, thereby adapting to the wall adhesion requirements of the lumen during ablation of different lesions, thereby achieving improved adaptability while ensuring the ablation effect.

[0115] In some possible embodiments, the electrode assembly 10 satisfies at least one of the following features: the spacing between two adjacent electrodes 102 is 5 mm-20 mm; the length of the electrode assembly 10 is 10 mm-40 mm. By setting the spacing between two adjacent electrodes 102 to the above range, the ductility of the electrode assembly 10 can be ensured, and the ablation effect of the electrode assembly 10 can be ensured.

[0116] In this embodiment, the number of electrodes 102 included in the electrode assembly 10 is not limited, as long as the distance between two adjacent electrodes 102 is within the above range and the length of the electrode assembly 10 is within the above range.

[0117] In this embodiment, the spacing between two adjacent electrodes 102 is 5mm-10mm, 5mm-15mm, 5mm-20mm, 10mm-15mm, 10mm-20mm or 15mm-20mm, etc.; the length of the electrode assembly 10 is 10mm-20mm, 10mm-30mm, 15mm-40mm, 20mm-40mm, 20mm-35mm or 30mm-40mm, etc.

[0118] In some possible embodiments, the positive and negative polarities of two adjacent electrodes 102 are opposite. The above arrangement can ensure that the ablation range is less affected by tissue impedance, and the ablation energy is concentrated around the electrode 102, thereby increasing the ablation range of the electrode assembly 10 and avoiding the problem that the ablation range of a single electrode 102 is narrow, which makes the ablation effect easily affected by the air in the lungs and causes incomplete ablation. More importantly, the pulse energy range generated by the bipolar electrode 102 is controllable, thereby ensuring that the pulse energy damage range is controllable, thereby achieving the technical effect of less damage to adjacent nerves and blood vessels and fewer postoperative complications.

[0119] In this embodiment, the electrode assembly 10 includes two electrodes 102, the first electrode 102 is electrically connected to the negative electrode, and the second electrode 102 is electrically connected to the positive electrode, so that the positive and negative polarities of the two electrodes 102 are opposite, thereby achieving bipolar ablation.

[0120] In some possible embodiments, the two ends of the tubular structure are respectively a first polymerization end 1022 and a second polymerization end 1023; the first polymerization end 1022 and the second polymerization end 1023 are arranged along the axial direction of the delivery tube assembly, the first polymerization end 1022 is arranged near the distal end of the tube body 20, and the second polymerization end 1023 is arranged near the proximal end of the tube body 20; one end of the delivery tube assembly is fixedly connected to the second polymerization end 1023 of the electrode 102 arranged near the proximal end of the tube body 20; one end of the traction structure 201 passes through the delivery tube assembly and extends into the electrode assembly 10, and is fixedly connected to the first polymerization end 1022 of the electrode 102 arranged near the distal end of the tube body 20, through After passing one end of the traction structure 201 through the delivery tube assembly, it is fixedly connected to the first aggregation end 1022 of the electrode 102 arranged near the distal end of the tube body 20. The delivery tube assembly is fixedly connected to the second aggregation end 1023 of the electrode 102 arranged near the proximal end of the tube body 20, and the two adjacent electrodes 102 are fixedly connected via the connecting tube 103. Such a configuration can ensure that each electrode 102 in the electrode assembly 10 can be contracted or expanded synchronously, so that the electrode assembly 10 can bend and expand with the bronchial cavity, flexibly adjust the shape of the electrode 102 to adapt to the lesion structure, and achieve a larger area of ​​electrode and lesion contact, thereby improving the success rate of pulse ablation.

[0121] In this embodiment, the length and shape of the first polymerization end 1022 and the second polymerization end 1023 are not limited, as long as the diameter of the first polymerization end 1022 and the second polymerization end 1023 is not greater than the diameter of the extension section 1021 in the contracted state.

[0122] In this embodiment, the first polymer end 1022 and the second polymer end 1023 are made of a material that is not easily deformed, and both the first polymer end 1022 and the second polymer end 1023 are annular structures.

[0123] In this embodiment, the first aggregation end 1022, the extension section 1021 and the second aggregation end 1023 are integrally formed or separately provided, which is specifically provided according to actual conditions and is not limited here.

[0124] In this embodiment, the electrode 102 may be a tubular structure with a cavity inside, which is formed by a grid array structure, a simply supported beam structure, or a balloon structure.

[0125] The electrode assembly 10 is configured to transmit nanosecond and / or microsecond pulsed electric field energy to the target lesion for irreversible electroporation ablation; in order to improve the depth and safety of transbronchial interventional ablation and reduce the tumor recurrence rate, the electrode assembly 10 is configured so that at least two adjacent electrodes 102 can contact the lesion to achieve bipolar ablation, that is, the pulsed electric field is transmitted through adjacent opposite-sex electrodes. Compared with monopolar ablation, the ablation depth is greater under the same pulse energy parameters and the effect on muscle tremor is smaller; at the same time, the electrode assembly 10 adopts an "island-bridge" flexible structure design in which adjacent electrodes 102 are spaced apart, which can further reduce the stiffness of the electrode 102, improve the ductility of the electrode 102, and increase the coverage area of ​​the electrode 102 compared with conventional non-ductile ring electrode or needle electrode structures; the electrode assembly 10 is composed of a grid array, a simply supported beam structure or a balloon structure, etc., which avoids the adverse effects of increased length or diameter of the electrode 102 on delivery and adhesion, and achieves better peripheral transbronchial delivery and conformal ablation of the lung.

[0126] In some possible embodiments, the electrode 102 is a tubular structure woven from metal wires. Such a configuration can ensure the connection stability of the electrode 102, and when the electrode 102 is rotated at any angle, it is guaranteed to have a maximum contact area with the lesion, further ensuring the ablation effect; at the same time, it avoids the adverse effects of increased length or diameter of the electrode 102 on delivery and adhesion, thereby achieving better delivery effect and conformal ablation.

[0127] In this embodiment, the electrode 102 is a grid array structure, and the electrode 102 is woven by metal wires, and the weaving method is one-on-one or one-on-two or two-on-two; the metal wire is preferably medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver and other metals; multiple metal wires on the electrode 102 form a mesh conductive surface for transmitting pulse energy, and at the same time have good deformation ability. On the basis of the interval setting of the electrode 102 in the electrode assembly 10, the deformation ability of the electrode 102 can be further improved, so that the flexible electrode pulse ablation catheter is easy to bend, and the shape of the electrode 102 can be flexibly adjusted to adapt to the lesion structure, so that a larger area of ​​the electrode 102 can be attached to the lesion, thereby improving the success rate of pulse ablation.

[0128] In this embodiment, the electrode 102 woven from metal wires includes a first polymerization end 1022, an extension segment 1021 and a second polymerization end 1023 in sequence, and the first polymerization end 1022, the extension segment 1021 and the second polymerization end 1023 are integrally formed. Under the action of the traction structure 201, the first polymerization end 1022 and the second polymerization end 1023 of the electrode 102 can move toward each other to compress the extension segment 1021, thereby increasing the diameter of the extension segment 1021 and increasing the contact area with the lesion, or the first polymerization end 1022 and the second polymerization end 1023 can move away from each other to compress the extension segment 1021, thereby reducing the diameter of the extension segment 1021, so as to facilitate the transportation of the electrode 102.

[0129] In some possible embodiments, the electrode 102 also includes an extension segment 1021, and the two ends of the extension segment 1021 are fixedly connected to the first aggregation end 1022 and the second aggregation end 1023 respectively; the extension segment 1021 includes at least two first connectors, and the at least two first connectors are arranged at circumferential intervals around the delivery tube assembly. By arranging at least two first connectors at circumferential intervals around the delivery tube assembly, it is possible to increase the ductility of the extension segment 1021 while ensuring the contact area between the extension segment 1021 and the lesion, thereby increasing the flexibility of the electrode 102, so as to achieve the ability to flexibly adjust the shape of the electrode 102 to adapt to the lesion structure, and achieve a larger area of ​​the electrode 102 in contact with the lesion, thereby improving the success rate of pulse ablation; at the same time, it avoids the adverse effects of increased length or diameter of the electrode 102 on delivery and contact, and achieves better delivery effect and conformal ablation.

[0130] In some possible embodiments, along the first aggregation end 1022 to the second aggregation end 1023, the surface slope of the first connecting member gradually changes from small to large, and then gradually changes from large to small, so as to form an arch structure. By setting the first connecting member as an arch structure, it can be ensured that the electrode 102 can bend and deform under the slight action of the traction structure 201, which increases the sensitivity of the electrode 102 transformation, improves the response speed of the flexible electrode pulse ablation catheter, saves ablation time, and improves user experience.

[0131] In this embodiment, the first connecting member is a simply supported beam. Initially, that is, when the electrode 102 is in a contracted state, the simply supported beam is closed to form a micro-arch structure. When the electrode 102 is in an expanded state, the simply supported beam is bent along its thickness direction.

[0132] In this embodiment, in order to achieve the expected expanded shape of the electrode 102, the extended section 1021 of the simply supported beam is initially an arched structure; in some schemes, the arched structure is achieved by pre-stressing assembly, that is, the electrode 102 is moved toward the proximal end through the traction structure 201 to maintain the pre-stressed installation, resulting in a slight bending deformation of the extended section 1021 of the simply supported beam; when fully expanded, the traction structure 201 is moved toward the proximal end by operating the handle assembly until the ellipsoidal surface is expanded; in other schemes, the arched structure can also be achieved by pre-forming, that is, the simply supported beam is fixed on a shaping tool, and pre-bending and shaping is achieved through high-temperature heat treatment.

[0133] In some possible embodiments, when the electrode 102 is in a compressed state, the length direction of the first connector is parallel to the axial direction of the delivery tube assembly, and the thickness direction of the first connector passes through the axis of the delivery tube assembly, and the first connector satisfies at least one of the following characteristics: the thickness of the first connector is much smaller than the width of the first connector; the width of the first connector is much smaller than the length of the first connector; the number of first connectors is 2-14. By restricting the first connector as above, the ductility of the first connector can be guaranteed, thereby increasing the flexibility of the electrode 102, so as to achieve the ability to flexibly adjust the shape of the electrode 102 to adapt to the lesion structure, and achieve a larger area of ​​the electrode 102 in contact with the lesion, thereby improving the success rate of pulse ablation.

[0134] In some possible embodiments, an extension segment 1021 is further included, and both ends of the extension segment 1021 are fixedly connected to the first polymerization end 1022 and the second polymerization end 1023 respectively; the extension segment 1021 includes a balloon membrane and an electrode membrane arranged in sequence from the inside to the outside, and the interior of the balloon membrane has a sealed cavity, which can be connected to the delivery tube assembly, and the liquid can enter or move away from the sealed cavity through the delivery tube assembly to drive the balloon membrane to contract or expand. By further providing the extension segment 1021 that can be extended radially between the first polymerization end 1022 and the second polymerization end 1023, the contact area between the electrode 102 and the lesion can be ensured, while avoiding the adverse effects of the increase in the length or diameter of the electrode 102 on the delivery and contact, thereby achieving a better delivery effect and conformal ablation.

[0135] In this embodiment, the balloon membrane is a compliant or semi-compliant film.

[0136] In some possible embodiments, the electrode membrane includes at least two second connectors, and the at least two second connectors are arranged at circumferential intervals around the balloon membrane. By providing at least two second connectors, the strength of the electrode membrane can be reduced and the ductility of the electrode membrane can be improved on the basis of ensuring the contact area, making it easier to deform and enabling the electrode membrane to flexibly adjust the shape of the electrode 102 to adapt to the lesion structure, thereby achieving a larger area of ​​contact between the electrode 102 and the lesion, thereby improving the success rate of pulse ablation.

[0137] In some possible embodiments, the electrode film satisfies at least one of the following characteristics: the thickness of the electrode film is 10μm-100μm; the electrode film is a multi-layer film structure, and by setting the thickness of the electrode film to the above range, it can ensure that it limits the balloon membrane set therein, and can ensure that the electrode film is easy to deform under the action of external force, thereby ensuring the fitting area between the electrode film and the lesion, thereby ensuring the ablation effect.

[0138] In some possible embodiments, when the electrode 102 is in a compressed state, the length direction of the second connector is parallel to the axial direction of the delivery tube assembly, and the thickness direction of the second connector passes through the axis of the delivery tube assembly, and the second connector satisfies at least one of the following characteristics: the thickness of the second connector is much smaller than the width of the second connector; the width of the second connector is much smaller than the length of the second connector; the number of second connectors is 2-10. By restricting the second connector as above, the ductility of the second connector can be guaranteed, thereby increasing the flexibility of the electrode 102, so as to achieve the ability to flexibly adjust the shape of the electrode 102 to adapt to the lesion structure, and achieve a larger area of ​​the electrode 102 in contact with the lesion, thereby improving the success rate of pulse ablation.

[0139] In this embodiment, the electrode film 1021b has a multilayer film structure; the outer surface of the electrode film 1021b away from the balloon membrane 1021a is a conductive material, preferably a biocompatible material such as gold, platinum, titanium, tungsten, palladium, silver, etc.; the inner surface of the electrode film 1021b close to the balloon membrane 1021a is a flexible substrate, preferably a biocompatible material such as polyurethane or polyimide; the multilayer structure of the electrode film 1021b is manufactured by semiconductor processes, such as magnetron sputtering, electroplating, chemical etching, etc., and the overall thickness is controlled between 10μm and 100μm; the electrode film 1021b has a flexible microstructure, such as transition connection through a serpentine wire, which is used to achieve conformal connection and folding compression with the balloon membrane 1021a; during transportation, the electrode film 1021b is emptied and collapsed with the balloon membrane 1021a, and is in a coiled and folded state, with a maximum diameter D0 of During operation, the extended section 1021 of the electrode 102 expands the balloon membrane 1021a by injecting liquid inside, driving the electrode membrane 1021b to expand to a maximum diameter D1 of

[0141] Furthermore, a traction structure 201 is provided inside the electrode 102; an insulating tube 202 is movably sleeved on the upper part of the traction structure 201, and a channel tube 203 is movably sleeved on the outer part of the insulating tube 202; an injection channel is provided between the traction structure 201 and the insulating tube 202, which is used for the infusion and expansion of the balloon membrane 1021a on the electrode 102 near the distal end of the tube body 20; an injection channel is provided between the insulating tube 202 and the channel tube 203, which is used for the infusion and expansion of the balloon membrane 1021a on the electrode 102 near the proximal end of the tube body 20.

[0142] In some possible embodiments, the electrode assembly 10 also includes a cap 101 and a rigid electrode 104; the first end of the cap 101 is provided with an arc surface, and the second end of the cap 101 is provided with a traction structure mounting position and a polymerization end mounting position; the traction structure mounting position is used to be fixedly connected to one end of the traction structure 201; the first end of the rigid electrode 104 is fixedly connected to the second polymerization end 1023 of the electrode 102 arranged near the proximal end of the tube body 20, the second end of the rigid electrode 104 is fixedly connected to the tube body 20, and the polymerization end mounting position is used to be fixedly connected to the first polymerization end 1022 of the electrode 102 arranged near the distal end of the tube body 20. By setting the cap 101, the electrode 102 near the distal end of the tube body 20 can be fixed. At the same time, setting the cap 101 with an arc surface can prevent the cap 101 from causing damage to the human body during movement, thereby improving the safety of the flexible electrode pulse ablation catheter.

[0143] Specifically, the cap 101 and the rigid electrode 104 are both made of developing materials, the cap 101 can play the role of a rigid electrode, the polarity of the cap 101 is the same as the polarity of the adjacent electrode 102 , and the rigid electrode 104 is the same as the polarity of the adjacent electrode 102 .

[0144] In some possible embodiments, the length of the cap 101 is shorter than the length of the electrode 102 , and the length of the rigid electrode 104 is shorter than the length of the electrode 102 .

[0145] Preferably, the length of the cap 101 is 30%-60% of the length of the electrode 102 , and the length of the rigid electrode 104 is 30%-60% of the length of the electrode 102 .

[0146] In some possible embodiments, both the cap 101 and the rigid electrode 104 can be relative to the electrode 102, that is, at least one of the cap 101 and the rigid electrode 104 can be equivalent to the electrode 102; when the electrode assembly 10 includes two electrodes 102, the cap 101 or the rigid electrode 104 can be equivalent to the electrode 102, thereby realizing that the electrode assembly 10 includes two electrodes 102.

[0147] See attached Fig. 20At this time, the electrode assembly 10 includes an electrode 102, and the electrode 102 is in an expanded state. When the electrode 102 is in a contracted state, the diameter of the electrode 102 is smaller than the diameter of the electrode 102 in the expanded state; along the length direction of the electrode assembly 10, the electrode assembly 10 includes a cap 101, a connecting tube 103, an electrode 102 and a rigid electrode 104. At this time, the cap 101 is a rigid electrode, and is equivalent to the electrode 102, and can play the role of a rigid electrode. The cap 101 and the electrode 102 are spaced apart by the connecting tube 103. At this time, the polarities of the cap 101 and the electrode 102 are opposite, and the polarity of the electrode 102 is the same as that of the rigid electrode 104.

[0148] See attached Fig.21 At this time, the electrode assembly 10 includes an electrode 102, and the electrode 102 is in an expanded state. When the electrode 102 is in a contracted state, the diameter of the electrode 102 is smaller than the diameter of the electrode 102 in the expanded state; along the length direction of the electrode assembly 10, the electrode assembly 10 includes a cap 101, an electrode 102, a connecting tube 103 and a rigid electrode 104. At this time, the cap 101 is equivalent to a rigid electrode and can play the role of a rigid electrode. The electrode 102 and the rigid electrode 104 are spaced apart by the connecting tube 103. The rigid electrode 104 is equivalent to the electrode 102. At this time, the polarities of the electrode 102 and the rigid electrode 104 are opposite, and the polarities of the cap 101 and the electrode 102 are the same.

[0149] In this embodiment, the structures of two adjacent electrodes 102 are the same or different, which is not limited here. Preferably, the structures of two adjacent electrodes 102 are the same. When the structures of two adjacent electrodes 102 are different, the electrode 102 can be a tubular structure woven from metal wires, or the extension section 1021 can include at least two first connecting members, and the at least two first connecting members are arranged at circumferential intervals around the delivery tube assembly, or the extension section 1021 can include a balloon membrane and an electrode membrane arranged in sequence from the inside to the outside.

[0150] See attached Fig. 22At this time, the electrode assembly 10 includes two electrodes 102, both of which are in the expanded state. When the electrode 102 is in the contracted state, the diameter of the electrode 102 is smaller than the diameter of the electrode 102 in the expanded state; along the length direction of the electrode assembly 10, the electrode assembly 10 includes a cap 101, a first electrode 102, a connecting tube 103, a second electrode 102 and a rigid electrode 104. At this time, the cap 101 is equivalent to a rigid electrode and can play the role of a rigid electrode. The cap 101 and the adjacent electrode 102 have the same polarity, and the rigid electrode 104 and the adjacent electrode 102 have the same polarity; the first electrode 102 and the second electrode 102 are spaced apart by the connecting tube 103. At this time, the extended section 1021 of the first electrode 102 includes at least two first connecting members, and the at least two first connecting members are spaced apart around the circumference of the conveying tube assembly. The second electrode 102 is a tubular structure woven from metal wires.

[0151] See attached Fig.23 At this time, the electrode assembly 10 includes two electrodes 102, and the two electrodes 102 are in the expanded state. When the electrode 102 is in the contracted state, the diameter of the electrode 102 is smaller than the diameter of the electrode 102 in the expanded state; along the length direction of the electrode assembly 10, the electrode assembly 10 includes a cap 101, a first electrode 102, a connecting tube 103, a second electrode 102 and a rigid electrode 104. At this time, the cap 101 is equivalent to a rigid electrode and can play the role of a rigid electrode. The cap 101 and the adjacent electrode 102 have the same polarity, and the rigid electrode 104 and the adjacent electrode 102 have the same polarity; the first electrode 102 and the second electrode 102 are spaced apart by the connecting tube 103. At this time, the first electrode 102 is a tubular structure woven from metal wires, and the extended section 1021 of the second electrode 102 includes a balloon membrane and an electrode membrane arranged in sequence from the inside to the outside.

[0152] In some possible embodiments, the cap member 101 includes an end cap 1011 and an electrode ring 1012; the arc surface is arranged at the first end of the end cap 1011, and the electrode ring 1012 is fixedly connected to the second end of the end cap 1011. After the electrode ring 1012 is connected to the second end of the end cap 1011, a polymer end mounting position is formed between the electrode ring 1012 and the end cap 1011; the traction structure mounting position is arranged at the second end of the end cap 1011, and by arranging the end cap 1011 and the electrode ring 1012 that cooperate with each other, the installation and disassembly of the electrode 102 can be facilitated, thereby shortening the preparation time of the flexible electrode pulse ablation catheter.

[0153] In this embodiment, the distal end of the end cap 1011 is the end 1011a, and the proximal end is the connecting column 1011b; the end cap 1011 and the electrode ring 1012 are fixedly connected by welding, clamping or bonding; the end 1011a of the end cap 1011 is a semicircular or conical structure, and the connecting column 1011b of the end cap 1011 is provided with a blind hole, and is fixedly connected to the traction structure 201; the end cap 1011 and the electrode ring 1012 are conductive materials, preferably medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver and other metals.

[0154] In this embodiment, the area where the blind hole is located in the connecting column 1011b is the installation position of the traction structure, and the annular area formed between the electrode ring 1012 and the end cap 1011 is the installation position of the aggregation end.

[0155] In some possible embodiments, the hardness of the tube body 20 gradually decreases from the proximal end to the distal end of the tube body 20. By gradually reducing the hardness of the tube body 20, it is possible to ensure the support of the proximal end of the tube body 20 and improve the flexibility of the distal end of the tube body 20, thereby ensuring that the electrode assembly 10 disposed at the distal end of the tube body 20 can be easy to move in a lesion with a larger curvature, thereby improving the delivery rate of the electrode assembly 10.

[0156] In this embodiment, the tube body 20 is configured to deliver the electrode assembly 10 to the lesion through the bronchoscope channel.

[0157] In this embodiment, the tube body 20 includes a traction structure 201 and a delivery tube assembly, and the hardness of the delivery tube assembly gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20 .

[0158] Preferably, the hardness of the outer catheter 204 gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20 .

[0159] In some other possible embodiments, the delivery tube assembly satisfies at least one of the following features: the hardness of the outer catheter 204 gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20; the hardness of the insulating tube 202 gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20; the hardness of the channel tube 203 gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20; the hardness of the stress tube 205 gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20.

[0160] In this embodiment, by gradually reducing the hardness of the outer catheter 204, the channel tube 203 and the insulating tube 202, the support of the proximal end of the tube body 20 can be guaranteed to the greatest extent, and the flexibility of the distal end of the tube body 20 can be maximized, so as to increase the flexibility of the lucky electrode pulse ablation catheter and improve the success rate of ablation.

[0161] In some possible embodiments, the tube body 20 is made of a material with a developing function, and the tube body 20 can adjust and confirm the position of the electrode 102 under X-rays, thereby improving the accuracy of delivering the electrode assembly 10 to the lesion.

[0162] In this embodiment, the material of the tube body 20 is at least one of polyetheramide, nylon, thermoplastic polyurethane, and polytetrafluoroethylene. The above materials can ensure that the electrode 102 can be transported in a curved or bifurcated lumen.

[0163] In some possible embodiments, along the radial direction of the delivery tube assembly, the delivery tube assembly is sequentially provided with an insulating tube 202, a channel tube 203, an outer catheter 204 and a stress tube 205; the first end of the outer catheter 204 is fixedly connected to the electrode assembly 10, the second end of the outer catheter 204 can be fixedly connected to the handle assembly 30, and the stress tube 205 is arranged at the connection position between the outer catheter 204 and the handle assembly 30; part of the wire electrically connected to the electrode 102 can extend into the insulating tube 202, and the insulating tube 202 is used to connect the wire electrically connected to the adjacent electrode 102 phase isolation; there is a gap between the inner wall of the channel tube 203 and the outer wall of the insulating tube 202, one end of the channel tube 203 is connected to the electrode assembly 10 to guide the liquid to the position of the electrode assembly 10 through the channel tube 203, and the insulating tube 202 in the delivery tube assembly is partially set, which can reduce the preparation cost of the delivery tube assembly and ensure the flexibility of the delivery tube assembly; only setting the stress tube 205 at the connection position between the outer catheter 204 and the handle assembly 30 can diffuse the stress at the connection, and can also improve the support of the proximal end of the delivery tube assembly.

[0164] In this embodiment, the traction structure 201 is a core shaft, and the two electrodes 102 are internally provided with a core shaft, the upper part of the core shaft can be provided with an insulating tube 202, and the outer part of the insulating tube 202 can be movably provided with a channel tube 203, and the outer side of the channel tube 203 is connected to the outer catheter 204, and the fixed connection between the outer catheter 204 and the handle assembly 30 is provided with a stress tube 205. By providing the stress tube 205, the stress at the connection between the outer catheter 204 and the handle assembly 30 can be evenly diffused, so as to avoid the outer catheter 204 being easily broken due to the stress, thereby improving the service life of the outer catheter 204; the outer catheter 204 is preferably a composite reinforced tube structure such as a braided tube and a spring tube.

[0165] In this embodiment, when the electrode assembly 10 includes two electrodes 102, the connecting wire of the electrode 102 arranged near the distal end of the tube body 20 passes through the inner side of the insulating tube 202 to the inside of the shell of the handle assembly 30 and is electrically connected to the positive cable, and the connecting wire of the electrode 102 arranged near the proximal end of the tube body 20 passes through the inner side of the insulating tube 202 to the inside of the shell of the handle assembly 30 and is electrically connected to the negative cable.

[0166] In some possible embodiments, at least one position detection device 40 is further included. At least one position detection device 40 is arranged inside the electrode 102 and fixedly arranged on the traction structure 201. By setting the position detection device 40, the position, shape and temperature information of the electrode 102 can be collected and communicated. Through real-time electromagnetic positioning navigation guidance, the delivery planning of the electrode 102 is realized, the difficulty of arranging and delivering the electrode 102 is reduced, and the ablation effect is further improved.

[0167] In the present embodiment, at least one of the at least two electrodes 102 is internally insulated and installed with a position detection device 40, which includes but is not limited to a positioning sensor and / or a morphology sensing optical fiber and / or a temperature sensor, and is used for real-time monitoring of the position data and / or electrode morphology data and / or temperature information of the electrode 102; when the position detection device 40 is configured as a positioning sensor, at least one positioning sensor is arranged at the first aggregation end 1022 of the electrode 102 arranged near the far end of the tube body 20, and is used to collect the position and direction data of the electrode 102, and realize three-dimensional model reconstruction of the electrode 102 in space according to the above position coordinate information; the positioning sensor and the electrode 1021 are insulated and isolated by high dielectric strength materials such as polyimide and tetrafluoroethylene; the positioning sensor is preferably a 5DOF or 6DOF electromagnetic positioning sensor, which can measure the spatial position coordinates of the electrode assembly 10 in real time, and relay the position and direction data to the ablation system interface for visualization, thereby improving the user experience and increasing market share.

[0168] The second aspect of the present invention also protects a pulse ablation device, including a handle assembly 30 and a flexible electrode 102 pulse ablation catheter as above; the first end of the handle assembly 30 can be electrically connected to an ablation mechanism that emits ablation energy; one end of the delivery tube assembly is fixedly connected to the second end of the handle assembly 30, and one end of the traction structure 201 passes through the delivery tube assembly and is drive-connected to the handle assembly 30. The handle assembly 30 can drive the traction structure 201 to reciprocate along the axial direction of the delivery tube assembly relative to the delivery tube assembly. The pulse ablation device in this embodiment can be delivered through a bronchoscope for local bipolar mode ablation. The electrode 102 has bending ductility, a high coverage area of ​​the electrode 102, and is less affected by tissue impedance, and has a slight effect on muscle tremors. With the assistance of the electrode assembly 10 and electromagnetic positioning navigation, the location of the lesion and the location of important structures can be determined in real time, and the ablation electrode assembly 10 can be accurately delivered to the inside of the tumor for ablation, thereby reducing postoperative complications and improving the ablation success rate of irreversible electroporation.

[0169] In some possible embodiments, the handle assembly 30 includes at least two wires, a rotating wheel mechanism 301 and a connector assembly 302; the rotating wheel mechanism 301 is fixedly connected to one end of the traction structure 201, and the rotating wheel mechanism 301 drives the traction structure 201 to reciprocate along the axial direction of the delivery tube assembly relative to the delivery tube assembly under the action of an external force; the first ends of the at least two wires are electrically connected to the connector assembly 302, the connector assembly 302 is located at the first end of the handle assembly 30, and the connector assembly 302 is electrically connected to the ablation mechanism; the second ends of the at least two wires They are electrically connected to at least two electrodes 102 respectively so that the positive and negative polarities of two adjacent electrodes 102 are opposite. By arranging mutually matching wires, a rotating wheel mechanism 301 and a connector assembly 302, it is possible to realize that the electrode 102 can be electrically connected to the connector assembly 302 through the wire, and the electrode 102 is fixedly connected to the rotating wheel mechanism 301 through the traction structure 201. Driven by the traction structure 201, it reciprocates relative to the delivery tube assembly, and current can be supplied to the electrode 102 through the connector assembly 302 to achieve ablation of the lesion.

[0170] In this embodiment, the handle assembly 30 also includes a shell having an accommodating cavity therein, part of the rotating wheel mechanism 301 is arranged in the shell, and part of the rotating wheel mechanism 301 is protruded from the outer wall of the shell to facilitate the operator to rotate the rotating wheel mechanism 301; the wire part is arranged in the shell, and the connector assembly 302 is fixed on the shell, and the connector assembly 302 is electrically connected to the wire arranged in the shell.

[0171] In this embodiment, the shell of the handle assembly 30 is electrically insulated from the electrode assembly 10 and is electrically connected to the ablation device via the connector assembly 302; the proximal end of the traction structure 201 is connected to the rotating wheel mechanism 301 to achieve axial reciprocating movement, thereby driving the expansion or contraction adjustment of the extended section 1021 of the electrode 102; the connector assembly 302 includes a pulse cable and a pulse connector, a sensor cable and a sensor connector; the pulse cable and the pulse connector are electrically connected to the electrode assembly 10; the sensor cable and the sensor connector are electrically connected to the position detection device 40; the pulse connector and the sensor connector are communicatively connected to the ablation device.

[0172] In this embodiment, the specific structure of the rotating wheel mechanism 301 is not limited, as long as the rotating wheel mechanism 310 can drive the traction structure 201 to move relative to the conveying pipe assembly when rotating.

[0173] In this embodiment, the shell of the handle assembly 30 has two open ends arranged opposite to each other, one open end is fixedly connected to the delivery tube assembly, and the other open end is used to pass the cable through to install the connector assembly 302; after the open end on one side is fixedly connected to the delivery tube assembly, a stress tube 205 is sleeved at the connection position between the shell and the delivery tube assembly.

[0174] In some possible embodiments, a direction mark and / or an extended length mark is provided on the shell of the handle assembly 30; wherein the direction mark is used to instruct the operator to rotate the rotating wheel mechanism 301 toward a first direction, and the flexible electrode pulse ablation catheter is extended, or to rotate the rotating wheel mechanism 301 toward a second direction, and the flexible electrode pulse ablation catheter is shortened, and the first direction and the second direction are opposite.

[0175] In this embodiment, the shell of the handle assembly 30 includes a rotating area and a holding area which are connected to each other. The rotating wheel mechanism 301 is arranged in the rotating area, and the operator's hand is placed in the holding area. This facilitates operation, improves user experience, and further improves market competitiveness.

[0176] The third aspect of the present invention also protects a pulse ablation device, including an ablation mechanism and the pulse ablation device as above; the ablation mechanism is used to provide at least one pulse group 50 to the pulse ablation device. By arranging the pulse ablation device and the ablation mechanism to cooperate with each other, the ablation electrode assembly 10 can be accurately delivered to the interior of the tumor for ablation, thereby reducing postoperative complications and improving the ablation success rate of irreversible electroporation. At the same time, the ablation mechanism can provide pulse ablation energy with a pulse energy size corresponding to the diseased tissue cells of the lungs. The pulse only performs pulse ablation treatment on the diseased tissue cells of the lungs without destroying other tissue cells, thereby improving the adaptability of the pulse ablation device to a certain extent.

[0177] In this embodiment, the attached Fig.15 Where V1: SHV voltage value, T1: SHV pulse width, T3: first pulse interval, T4: second pulse interval, T5: pulse repetition interval, T6: group interval, N1: number of SHV sub-pulses, V2: LVV voltage value, T2: LLV pulse width, N2: number of LLV sub-pulses, N3: number of groups.

[0178] Fig.16 Schematic diagram of pulse electric field energy packet when the peak voltage plateau period is 100%, and the high-frequency and high-voltage sub-pulse 501 is a bipolar pulse, and the low-frequency and low-voltage sub-pulse 502 is a unipolar pulse. Fig.17 Schematic diagram of pulse electric field energy packet when the peak voltage plateau period is 80%, and the high-frequency and high-voltage sub-pulse 501 is a bipolar pulse, and the low-frequency and low-voltage sub-pulse 502 is a unipolar pulse; Fig.18 Schematic diagram of a pulse electric field energy packet when the peak voltage plateau is 80%, and the high-frequency and high-voltage sub-pulse 501 is a bipolar pulse, and the low-frequency and low-voltage sub-pulse 502 is a bipolar pulse; Fig.19 It is a schematic diagram of a pulse electric field energy packet when the peak voltage plateau period is 100%, and the high-frequency and high-voltage sub-pulse 501 is a bipolar pulse, and the low-frequency and low-voltage sub-pulse 502 is a bipolar pulse.

[0179] In some possible embodiments, the pulse group 50 ensures at least one high-frequency, high-voltage sub-pulse 501 and / or one low-frequency, low-voltage sub-pulse 502, the high-frequency, high-voltage sub-pulse 501 is a bipolar pulse, and the low-frequency, low-voltage sub-pulse 502 is a unipolar pulse or a bipolar pulse; wherein the bipolar pulse includes a positive pulse amplitude and a negative pulse amplitude, and by setting a low-frequency, high-voltage sub-pulse 501 and / or a low-frequency, low-voltage sub-pulse 502, the coverage range of the pulse group 50 can be improved, thereby increasing the range of ablation that can be performed by the pulse ablation setting.

[0180] In some possible embodiments, the pulse group 50 satisfies at least one of the following characteristics: the voltage amplitude range of the bipolar pulse of the high-frequency high-voltage sub-pulse 501 is 2000V-70000V; the pulse width of the bipolar pulse of the high-frequency high-voltage sub-pulse 501 is 50ns-50000ns; the number of bipolar pulses of the high-frequency high-voltage sub-pulse 501 is 1-5000; the amplitude voltage and bipolar pulse width of the unipolar pulse of the low-frequency low-voltage sub-pulse 502 are 2000V-70000V; the pulse width of the bipolar pulse of the high-frequency high-voltage sub-pulse 501 is 50ns-50000ns; the number of bipolar pulses of the high-frequency high-voltage sub-pulse 501 is 1-5000; the amplitude voltage and bipolar pulse width of The amplitude voltage of the pulse is 200V-3000V; the pulse width of the unipolar pulse and the pulse width of the bipolar pulse of the low-frequency and low-voltage sub-pulse 502 are 10μs-500μs; the number of unipolar pulses and the number of bipolar pulses of the low-frequency and low-voltage sub-pulse 502 are 1-5000; the number of pulse groups 50 is 1-5000. By setting the above range, it is ensured that the pulse ablation device can output energy stably and the ablation effect of the pulse ablation device is guaranteed.

[0181] In this embodiment, the voltage amplitude range of the bipolar pulse of the high-frequency high-voltage sub-pulse 501 is 2000V-5000V, 2000V-10000V, 5000V-10000V, 10000V-30000V, 20000V-50000V or 50000V-70000V, etc.; the pulse width of the bipolar pulse of the high-frequency high-voltage sub-pulse 501 is 50ns-500ns, 50ns-5000ns, 100ns-5000ns, 2000ns-50000ns, 3000ns-40000ns, 200 00ns-40000ns, 30000ns-50000ns or 40000ns-50000ns, etc.; the number of bipolar pulses of the high-frequency and high-voltage sub-pulses 501 is 1-100, 100-500, 500-2000, 500-5000, 1000-5000, 2000-3000, 3000-4000 or 4000-5000, etc.; the amplitude voltage of the unipolar pulse and bipolar pulse of the low-frequency and low-voltage sub-pulses 502 is 200V-300V, 200V-500V, 200V-1000V, 500V-1 000V, 500V-3000V, 1000V-2000V, 1000V-3000V or 2000V-3000V, etc.; the pulse width of the unipolar pulse and the bipolar pulse of the low-frequency and low-voltage sub-pulse 502 is 10μs-50μs, 10μs-100μs, 10μs-500μs, 50μs-500μs, 100μs-200μs, 100μs-500μs, 200μs-500μs or 300μs-500μs, etc.; the number of the unipolar pulse and the bipolar pulse of the low-frequency and low-voltage sub-pulse 502 is 1-100 , 1-500, 100-500, 100-1000, 100-5000, 500-1000, 500-2000, 500-5000, 1000-5000, 3000-5000 or 4000-5000, etc.; the number of pulse groups 50 is 1-5000, 1-100, 1-500, 100-500, 100-1000, 100-5000, 500-1000, 500-2000, 500-5000, 1000-5000, 3000-5000 or 4000-5000, etc.

[0182] In this embodiment, the bipolar pulse of the high-frequency high-voltage sub-pulse 501 consists of a positive pulse amplitude and a negative pulse amplitude, and the voltage amplitude range is preferably 2000V to 70000V; the pulse width of the bipolar pulse is preferably 50ns to 50000ns; a first pulse interval is provided between the positive pulse and the negative pulse of the bipolar pulse; a second pulse interval is provided between the bipolar pulses; optionally, the number of bipolar pulses is preferably 1 to 5000;

[0183] Optionally, the amplitude voltage of the unipolar pulse and the bipolar pulse of the low-frequency low-voltage sub-pulse 502 is preferably 200V to 3000V; the pulse width of the unipolar pulse and the bipolar pulse is preferably 10μs to 500μs; a second pulse interval is provided between the unipolar pulses; an inter-group period is provided between the pulse groups; the number of unipolar pulses and bipolar pulses is preferably 1 to 5000; the number of pulse groups is preferably 1 to 5000; a pulse repetition interval is provided between the bipolar pulses and the unipolar pulses; an inter-group period is provided between the pulse groups;

[0184] Optionally, the unipolar pulse and the bipolar pulse have a rising edge or a falling edge, or the rising edge and the falling edge exist at the same time, or the width of the rising edge or the falling edge is close to the pulse width; the rising edge and the falling edge time of the sub-pulse are 0 to 500ns, and the length of the peak voltage plateau period of a single sub-pulse accounts for 0 to 100% of the pulse width, Fig.16 Schematic diagram of the pulse electric field energy packet when the length of the peak voltage plateau period of a single sub-pulse accounts for 100% of the pulse width. Fig.17 Schematic diagram of the pulse electric field energy packet when the length of the peak voltage plateau period of a single sub-pulse accounts for 80% of the pulse width.

[0185] The working process of the pulse ablation device: the electrode assembly 10 and the tube body 20 are delivered to the lesion site through bronchoscope intervention; if the lesion location has been confirmed before the operation, the electrode assembly 10 and the tube body 20 can be inserted into the bronchoscope channel; then, the electromagnetic positioning technology is used to guide the tube body 20 to quickly reach the lesion site along the optimal path, and the electrode assembly 10 is delivered into the lesion, and finally the relative position of the electrode 102 and the lesion is confirmed by CT imaging to perform the ablation operation; optionally, if the lesion location is not confirmed before the operation, it can be delivered in conjunction with a guide sheath, and the adapted guide sheath is pre-pushed to the vicinity of the lesion through electromagnetic navigation, and the tube body 20 is withdrawn, and the lesion location is further confirmed by a radial ultrasound probe and biopsy;

[0186] After the location of the lesion is confirmed by pathological biopsy, the electrode assembly 10 is placed in place, and the rotating wheel mechanism 301 of the operating handle assembly 30 is properly unfolded. After confirming that the electrical impedance of the tissue is within an acceptable range, the low-dose pulsed electric field energy package is tested to observe the muscle contraction and ECG synchronization. After completion, normal ablation parameter ablation is performed; nanosecond and / or microsecond pulsed electric field energy packages are applied to the target area, which will change the permeability of organelles and / or cell membranes, leading to cell apoptosis or death. The synergistic ablation characteristics of high-frequency high-voltage sub-pulses and / or low-frequency low-voltage sub-pulses enable them to destroy cancer cells while minimizing the impact on surrounding normal tissues. A CT scan is performed immediately after the ablation operation or 24 hours after the operation to confirm that the real-time ablation range completely covers the tumor area; after confirming that there are no complications such as severe bleeding and pneumothorax, the flexible electrode pulse ablation device is removed to complete the operation.

[0187] Embodiment 1

[0188] See attached figure Figure 1-23 The present embodiment provides a flexible electrode pulse ablation catheter, comprising: a tube body 20 having a distal end and a proximal end relatively arranged, the tube body 20 comprising a traction structure 201 and a delivery tube assembly sleeved on the traction structure 201; an electrode assembly 10 arranged at the distal end of the tube body 20, the electrode assembly 10 comprising at least one connecting tube 103 and at least two electrodes 102, two adjacent electrodes 102 are fixedly connected by the connecting tube 103, and the electrode 102 is a tubular structure with a cavity inside; one end of the traction structure 201 passes through the delivery tube assembly and then extends into the electrode assembly 10, and is fixedly connected to one end of the electrode 102 arranged near the distal end of the tube body 20; under the action of external force, the traction structure 201 can reciprocate along the axial direction of the delivery tube assembly to drive the opposite ends of the same electrode 102 to move toward or away from each other until the tubular structure contracts or expands.

[0189] In this embodiment, the flexible electrode pulse ablation catheter is mainly used for lung tumors, especially for lung tumors with a large bending angle of the lung that are difficult to observe or difficult to enter; the flexible electrode pulse ablation catheter in the flexible electrode pulse ablation catheter is inserted into the lung diseased tissue through a bronchoscope, and the outer surfaces of at least two electrodes 102 are arranged to be in contact with the diseased tissue, so that the pulses formed between the at least two electrodes 102 can ablate the lung diseased tissue; by setting up the above flexible electrode pulse ablation catheter, the problems of the ablation catheter being difficult to bend and deform and the low coverage of the electrode 102, resulting in difficult delivery of the electrode 102 and a narrow ablation range, can be solved.

[0190] Preferably, the electrode assembly 10 includes two electrodes 102 that are spaced apart. The pulse formed between the two electrodes 102 that are spaced apart can emit a pulse with a width of microsecond level to the lesion tissue in the lung, so as to damage the stability of the cell membrane surface of the lesion tissue in the lung, and cause multiple hydrophilic micropores to appear on the cell surface of the lesion tissue in the lung, so as to destroy the homeostasis of the lesion tissue in the lung, and cause the lesion tissue in the lung to die, thereby achieving the therapeutic effect of pulse ablation of the lesion tissue in the lung.

[0191] In this embodiment, the tube body 20 includes a traction structure 201 and a delivery tube assembly, and the hardness of the delivery tube assembly gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20 .

[0192] Preferably, the conveying tube assembly satisfies at least one of the following characteristics: the hardness of the outer catheter 204 gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20; the hardness of the insulating tube 202 gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20; the hardness of the channel tube 203 gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20; the hardness of the stress tube 205 gradually decreases from the proximal end of the tube body 20 to the distal end of the tube body 20.

[0193] In this embodiment, the tube body 20 is made of a material having a developing function.

[0194] In this embodiment, the material of the tube body 20 is at least one of polyetheramide, nylon, thermoplastic polyurethane, and polytetrafluoroethylene. The above materials can ensure that the electrode 102 can be transported in a curved or bifurcated lumen.

[0195] In this embodiment, along the radial direction of the delivery tube assembly, the delivery tube assembly is sequentially provided with an insulating tube 202, a channel tube 203, an outer conduit tube 204 and a stress tube 205; the first end of the outer conduit tube 204 is fixedly connected to the electrode assembly 10, the second end of the outer conduit tube 204 can be fixedly connected to the handle assembly 30, and the stress tube 205 is arranged at the connection position between the outer conduit tube 204 and the handle assembly 30; part of the wire electrically connected to the electrode 102 can extend into the insulating tube 202, and the insulating tube 202 is used to isolate the wire electrically connected to the adjacent electrode 102; there is a gap between the inner wall of the channel tube 203 and the outer wall of the insulating tube 202, and one end of the channel tube 203 is connected to the electrode assembly 10 to guide the liquid to the position of the electrode assembly 10 through the channel tube 203.

[0196] In this embodiment, the traction structure 201 is a core shaft, and the two electrodes 102 are internally provided with a core shaft, the upper part of the core shaft can be provided with an insulating tube 202, and the outer part of the insulating tube 202 can be movably provided with a channel tube 203, and the outer side of the channel tube 203 is connected to the outer catheter 204, and the fixed connection between the outer catheter 204 and the handle assembly 30 is provided with a stress tube 205. By providing the stress tube 205, the stress at the connection between the outer catheter 204 and the handle assembly 30 can be evenly diffused, so as to avoid the outer catheter 204 being easily broken due to the stress, thereby improving the service life of the outer catheter 204; the outer catheter 204 is preferably a composite reinforced tube structure such as a braided tube and a spring tube.

[0197] In this embodiment, at least one position detection device 40 is further included. The at least one position detection device 40 is disposed inside the electrode 102 and fixedly disposed on the traction structure 201 .

[0198] In the present embodiment, at least one of the at least two electrodes 102 is internally insulated and installed with a position detection device 40, which includes but is not limited to a positioning sensor and / or a morphology sensing optical fiber and / or a temperature sensor, and is used for real-time monitoring of the position data and / or electrode morphology data and / or temperature information of the electrode 102; when the position detection device 40 is configured as a positioning sensor, at least one positioning sensor is arranged at the first aggregation end 1022 of the electrode 102 arranged near the far end of the tube body 20, and is used to collect the position and direction data of the electrode 102, and realize three-dimensional model reconstruction of the electrode 102 in space according to the above position coordinate information; the positioning sensor and the electrode 1021 are insulated and isolated by high dielectric strength materials such as polyimide and tetrafluoroethylene; the positioning sensor is preferably a 5DOF or 6DOF electromagnetic positioning sensor, which can measure the spatial position coordinates of the electrode assembly 10 in real time, and relay the position and direction data to the ablation system interface for visualization.

[0199] In this embodiment, the electrode assembly 10 includes a connecting tube 103 and two electrodes 102, the first polymer end 1022 of the first electrode 102 is fixedly connected to the first end of the traction structure 201, the second polymer end 1023 of the first electrode 102 is fixedly connected to the first end of the connecting tube 103, the second end of the connecting tube 103 is fixedly connected to the first polymer end 1022 of the second electrode 102, the second polymer end 1023 of the second electrode 102 is fixedly connected to the first end of the conveying tube assembly, the second end of the conveying tube assembly can be fixedly connected to the shell of the handle assembly 30, and the second end of the traction structure 201 can be fixedly connected to the rotating wheel mechanism 301 of the handle assembly 30.

[0200] In this embodiment, the electrode assembly 10 also includes a cap 101 and a rigid electrode 104; the first end of the cap 101 is provided with an arc surface, and the second end of the cap 101 is provided with a traction structure mounting position and a polymerization end mounting position; the traction structure mounting position is used to be fixedly connected to one end of the traction structure 201, and the polymerization end mounting position is used to be fixedly connected to the first polymerization end 1022 of the electrode 102 arranged near the distal end of the tube body 20; the first end of the rigid electrode 104 is fixedly connected to the second polymerization end 1023 of the electrode 102 arranged near the proximal end of the tube body 20, and the second end of the rigid electrode 104 is fixedly connected to the tube body 20.

[0201] In this embodiment, the cap member 101 includes an end cap 1011 and an electrode ring 1012; the arc surface is arranged at the first end of the end cap 1011, and the electrode ring 1012 is fixedly connected to the second end of the end cap 1011. After the electrode ring 1012 is connected to the second end of the end cap 1011, an aggregate end mounting position is formed between the electrode ring 1012 and the end cap 1011; the traction structure mounting position is arranged at the second end of the end cap 1011.

[0202] In this embodiment, the distal end of the end cap 1011 is the end 1011a, and the proximal end is the connecting column 1011b; the end cap 1011 and the electrode ring 1012 are fixedly connected by welding, clamping or bonding; the end 1011a of the end cap 1011 is a semicircular or conical structure, and the connecting column 1011b of the end cap 1011 is provided with a blind hole, and is fixedly connected to the traction structure 201; the end cap 1011 and the electrode ring 1012 are conductive materials, preferably medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver and other metals.

[0203] In this embodiment, the area where the blind hole is located in the connecting column 1011b is the installation position of the traction structure, and the annular area formed between the electrode ring 1012 and the end cap 1011 is the installation position of the aggregation end.

[0204] In this embodiment, when the electrode assembly 10 includes two electrodes 102, the connecting wire of the electrode 102 arranged near the distal end of the tube body 20 passes through the inner side of the insulating tube 202 to the inside of the shell of the handle assembly 30 and is electrically connected to the positive cable, and the connecting wire of the electrode 102 arranged near the proximal end of the tube body 20 passes through the inner side of the insulating tube 202 to the inside of the shell of the handle assembly 30 and is electrically connected to the negative cable.

[0205] In this embodiment, the outer diameter of the electrode 102 can be extended and deformed to increase the contact area with the lesion; the conductor part in the electrode 102 is preferably made of a material with excellent biocompatibility and corrosion resistance, such as medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver, platinum, titanium, tungsten, palladium and other materials.

[0206] In this embodiment, the electrode 102 satisfies at least one of the following characteristics: when the electrode 102 is in a contracted state, the maximum diameter of the electrode 102 is 0.5 mm-5 mm; when the electrode 102 is in an expanded state, the maximum diameter of the electrode 102 is 1.5 mm-20 mm.

[0207] In this embodiment, when the electrode 102 is in a contracted state, the cross section of the electrode 102 is cylindrical; when the electrode 102 is in an expanded state, the cross section of the electrode 102 is elliptical.

[0208] In this embodiment, the outer surface of the electrode 102 is a conductive surface. During the ablation process, the traction structure 201 drives the electrode 102 to contract or expand, and the traction structure 201 changes the axial distance of the extension segment 1021, thereby adjusting the diameter of the extension segment 1021, thereby adapting to the wall adhesion requirements of the lumen during ablation of different lesions.

[0209] In this embodiment, the electrode assembly 10 satisfies at least one of the following characteristics: the interval between two adjacent electrodes 102 is 5 mm-20 mm; and the length of the electrode assembly 10 is 10 mm-40 mm.

[0210] In this embodiment, the number of electrodes 102 included in the electrode assembly 10 is not limited, as long as the distance between two adjacent electrodes 102 is within the above range and the length of the electrode assembly 10 is within the above range.

[0211] In this embodiment, the two ends of the tubular structure are respectively a first polymerization end 1022 and a second polymerization end 1023; the first polymerization end 1022 and the second polymerization end 1023 are arranged along the axial direction of the conveying tube assembly, the first polymerization end 1022 is arranged close to the distal end of the tube body 20, and the second polymerization end 1023 is arranged close to the proximal end of the tube body 20; one end of the conveying tube assembly is fixedly connected to the second polymerization end 1023 of the electrode 102 arranged close to the proximal end of the tube body 20; one end of the traction structure 201 passes through the conveying tube assembly and extends into the electrode assembly 10, and is fixedly connected to the first polymerization end 1022 of the electrode 102 arranged close to the distal end of the tube body 20.

[0212] In this embodiment, the length and shape of the first polymerization end 1022 and the second polymerization end 1023 are not limited, as long as the diameter of the first polymerization end 1022 and the second polymerization end 1023 is not greater than the diameter of the extension section 1021 in the contracted state.

[0213] In this embodiment, the first polymer end 1022 and the second polymer end 1023 are made of a material that is not easily deformed, and both the first polymer end 1022 and the second polymer end 1023 are annular structures.

[0214] In this embodiment, the first aggregation end 1022, the extension section 1021 and the second aggregation end 1023 are integrally formed or separately provided, which is specifically provided according to actual conditions and is not limited here.

[0215] In this embodiment, the electrode 102 may be a tubular structure with a cavity inside, which is formed by a grid array structure, a simply supported beam structure, or a balloon structure.

[0216] In this embodiment, the electrode 102 is a tubular structure woven from metal wires. The electrode 102 is woven from metal wires in a one-on-one or one-on-two or two-on-two manner. The metal wires are preferably medical stainless steel, nickel-titanium alloy, platinum-iridium alloy, gold, silver and other metals.

[0217] In this embodiment, the electrode 102 woven from metal wires includes a first polymerization end 1022, an extension segment 1021 and a second polymerization end 1023 in sequence, and the first polymerization end 1022, the extension segment 1021 and the second polymerization end 1023 are integrally formed. Under the action of the traction structure 201, the first polymerization end 1022 and the second polymerization end 1023 of the electrode 102 can move toward each other to compress the extension segment 1021, thereby increasing the diameter of the extension segment 1021 and increasing the contact area with the lesion, or the first polymerization end 1022 and the second polymerization end 1023 can move away from each other to compress the extension segment 1021, thereby reducing the diameter of the extension segment 1021, so as to facilitate the transportation of the electrode 102.

[0218] In some other possible embodiments, the electrode 102 further includes an extension section 1021, both ends of which are fixedly connected to the first polymerization end 1022 and the second polymerization end 1023 respectively; the extension section 1021 includes at least two first connecting members, and the at least two first connecting members are arranged at intervals around the circumference of the conveying tube assembly.

[0219] In this embodiment, along the first aggregation end 1022 to the second aggregation end 1023, the surface slope of the first connecting member gradually increases from small to large, and then gradually decreases from large to small, so as to form an arch structure.

[0220] In this embodiment, the first connecting member is a simply supported beam. Initially, that is, when the electrode 102 is in a contracted state, the simply supported beam is closed to form a micro-arch structure. When the electrode 102 is in an expanded state, the simply supported beam is bent along its thickness direction.

[0221] In this embodiment, in order to achieve the expected expanded shape of the electrode 102, the extended section 1021 of the simply supported beam is initially an arched structure; in some schemes, the arched structure is achieved by pre-stressing assembly, that is, the electrode 102 is moved toward the proximal end through the traction structure 201 to maintain the pre-stressed installation, resulting in a slight bending deformation of the extended section 1021 of the simply supported beam; when fully expanded, the traction structure 201 is moved toward the proximal end by operating the handle assembly until the ellipsoidal surface is expanded; in other schemes, the arched structure can also be achieved by pre-forming, that is, the simply supported beam is fixed on a shaping tool, and pre-bending and shaping is achieved through high-temperature heat treatment.

[0222] In this embodiment, when the electrode 102 is in a compressed state, the length direction of the first connecting member is parallel to the axial direction of the conveying tube assembly, the thickness direction of the first connecting member passes through the axis of the conveying tube assembly, and the first connecting member satisfies at least one of the following characteristics: the thickness of the first connecting member is much smaller than the width of the first connecting member; the width of the first connecting member is much smaller than the length of the first connecting member; the number of the first connecting members is 2-14.

[0223] In other possible embodiments, an extension section 1021 is further included, and both ends of the extension section 1021 are fixedly connected to the first polymerization end 1022 and the second polymerization end 1023 respectively; the extension section 1021 includes a balloon membrane and an electrode membrane arranged in sequence from the inside to the outside, and the interior of the balloon membrane has a sealed cavity, which can be connected to the delivery tube assembly, and the liquid can enter or move away from the sealed cavity through the delivery tube assembly to drive the balloon membrane to contract or expand.

[0224] In this embodiment, the electrode membrane includes at least two second connecting members, and the at least two second connecting members are arranged at intervals around the circumference of the balloon membrane.

[0225] In this embodiment, the electrode film satisfies at least one of the following characteristics: the thickness of the electrode film is 10 μm-100 μm; and the electrode film is a multi-layer film structure.

[0226] In this embodiment, when the electrode 102 is in a compressed state, the length direction of the second connecting member is parallel to the axial direction of the delivery tube assembly, the thickness direction of the second connecting member passes through the axis of the delivery tube assembly, and the second connecting member satisfies at least one of the following characteristics: the thickness of the second connecting member is much smaller than the width of the second connecting member; the width of the second connecting member is much smaller than the length of the second connecting member; the number of the second connecting members is 2-10.

[0227] Furthermore, a traction structure 201 is provided inside the electrode 102; an insulating tube 202 is movably sleeved on the upper part of the traction structure 201, and a channel tube 203 is movably sleeved on the outer part of the insulating tube 202; an injection channel is provided between the traction structure 201 and the insulating tube 202, which is used for the infusion and expansion of the balloon membrane 1021a on the electrode 102 near the distal end of the tube body 20; an injection channel is provided between the insulating tube 202 and the channel tube 203, which is used for the infusion and expansion of the balloon membrane 1021a on the electrode 102 near the proximal end of the tube body 20.

[0228] The embodiments of the present application have been described above, and the above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and changes will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The selection of terms used herein is intended to best explain the principles of the embodiments, practical applications, or technical improvements in the market, or to enable other persons of ordinary skill in the art to understand the embodiments disclosed herein.

[0229] In the absence of conflict, the above embodiments and features in the embodiments can be combined with each other.

[0230] The above disclosure is only a preferred embodiment of the present application, and certainly cannot be used to limit the scope of rights of the present application. Therefore, equivalent changes made according to the claims of the present application are still within the scope covered by the present application.

Claims

1. A flexible electrode pulse ablation catheter, characterized in that: include: A tube body (20) having a distal end and a proximal end arranged opposite to each other, the tube body (20) comprising a traction structure (201) and a delivery tube assembly sleeved on the traction structure (201); an electrode assembly (10) disposed at the distal end of the tube body (20), the electrode assembly (10) comprising at least one connecting tube (103) and at least two electrodes (102), two adjacent electrodes (102) being fixedly connected via the connecting tube (103), and the electrode (102) being a tubular structure having a cavity inside; One end of the traction structure (201) passes through the delivery tube assembly and then extends into the electrode assembly (10), and is fixedly connected to one end of an electrode (102) disposed near the distal end of the tube body (20); Under the action of external force, the traction structure (201) can reciprocate along the axial direction of the delivery tube assembly to drive the opposite ends of the same electrode (102) to move toward or away from each other until the tubular structure contracts or expands.

2. The flexible electrode pulse ablation catheter according to claim 1, characterized in that: The electrode (102) satisfies at least one of the following characteristics: The electrode (102) is in a contracted state, and the maximum diameter of the electrode (102) is 0.5 mm to 5 mm; The electrode (102) is in an expanded state, and the maximum diameter of the electrode (102) is 1.5 mm-20 mm.

3. The flexible electrode pulse ablation catheter according to claim 2, characterized in that: When the electrode (102) is in a contracted state, the cross-section of the electrode (102) is cylindrical; when the electrode (102) is in an expanded state, the cross-section of the electrode (102) is elliptical.

4. The flexible electrode pulse ablation catheter according to claim 1, characterized in that: The electrode assembly (10) satisfies at least one of the following characteristics: The distance between two adjacent electrodes (102) is 5 mm to 20 mm; The length of the electrode assembly (10) is 10 mm-40 mm.

5. The flexible electrode pulse ablation catheter according to claim 1, characterized in that: The positive and negative polarities of two adjacent electrodes (102) are opposite.

6. The flexible electrode pulse ablation catheter according to claim 1, characterized in that: The two ends of the tubular structure are respectively a first polymerization end (1022) and a second polymerization end (1023); The first polymer end (1022) and the second polymer end (1023) are arranged along the axial direction of the delivery tube assembly, the first polymer end (1022) is arranged close to the distal end of the tube body (20), and the second polymer end (1023) is arranged close to the proximal end of the tube body (20); One end of the delivery tube assembly is fixedly connected to a second aggregation end (1023) of an electrode (102) disposed near the proximal end of the tube body (20); One end of the traction structure (201) passes through the delivery tube assembly and then extends into the electrode assembly (10), and is fixedly connected to a first aggregation end (1022) of an electrode (102) disposed near the distal end of the tube body (20).

7. The flexible electrode pulse ablation catheter according to any one of claims 1 to 6, characterized in that: The electrode (102) is a tubular structure woven from metal wires.

8. The flexible electrode pulse ablation catheter according to any one of claims 1 to 6, characterized in that: The electrode (102) further comprises an extension section (1021), and two ends of the extension section (1021) are respectively fixedly connected to the first polymerization end (1022) and the second polymerization end (1023); The extension section (1021) includes at least two first connecting members, and the at least two first connecting members are arranged at intervals around the circumference of the conveying pipe assembly.

9. The flexible electrode pulse ablation catheter according to claim 8, characterized in that: When the electrode (102) is in a compressed state, the length direction of the first connecting member is parallel to the axial direction of the delivery tube assembly, the thickness direction of the first connecting member passes through the axis of the delivery tube assembly, and the first connecting member meets at least one of the following characteristics: The thickness of the first connecting member is much smaller than the width of the first connecting member; The width of the first connecting member is much smaller than the length of the first connecting member; The number of the first connecting members is 2-14.

10. The flexible electrode pulse ablation catheter according to claim 8, characterized in that: Along the first aggregation end (1022) to the second aggregation end (1023), the surface slope of the first connecting member gradually increases from small to large, and then gradually decreases from large to small, so as to form an arch structure.

11. The flexible electrode pulse ablation catheter according to any one of claims 1 to 6, characterized in that: It also includes an extension section (1021), wherein two ends of the extension section (1021) are respectively fixedly connected to the first polymerization end (1022) and the second polymerization end (1023); The extension section (1021) includes a balloon membrane and an electrode membrane arranged in sequence from the inside to the outside. The balloon membrane has a sealed cavity inside, and the sealed cavity can be connected to the delivery tube assembly. Liquid can enter or move away from the sealed cavity through the delivery tube assembly to drive the balloon membrane to contract or expand.

12. The flexible electrode pulse ablation catheter according to claim 11, characterized in that: The electrode membrane includes at least two second connectors, and the at least two second connectors are spaced apart around the circumference of the balloon membrane.

13. The flexible electrode pulse ablation catheter according to claim 12, characterized in that: The electrode film satisfies at least one of the following characteristics: The thickness of the electrode film is 10 μm-100 μm; The electrode film is a multi-layer film structure.

14. The flexible electrode pulse ablation catheter according to claim 12, characterized in that: When the electrode (102) is in a compressed state, the length direction of the second connecting member is parallel to the axial direction of the delivery tube assembly, the thickness direction of the second connecting member passes through the axis of the delivery tube assembly, and the second connecting member meets at least one of the following characteristics: The thickness of the second connecting member is much smaller than the width of the second connecting member; The width of the second connecting member is much smaller than the length of the second connecting member; The number of the second connecting members is 2-10.

15. The flexible electrode pulse ablation catheter according to any one of claims 1 to 6, characterized in that: The electrode assembly (10) further comprises a cap (101) and a rigid electrode (104); The first end of the cap member (101) is provided with an arc surface, and the second end of the cap member (101) is provided with a traction structure mounting position and a polymerization end mounting position; The traction structure mounting position is used for fixed connection with one end of the traction structure (201), and the polymerization end mounting position is used for fixed connection with a first polymerization end (1022) of an electrode (102) arranged near the distal end of the tube body (20); The first end of the rigid electrode (104) is fixedly connected to the second aggregate end (1023) of the electrode (102) disposed near the proximal end of the tube body (20), and the second end of the rigid electrode (104) is fixedly connected to the tube body (20).

16. The flexible electrode pulse ablation catheter according to claim 15, characterized in that: The cap member (101) comprises an end cap (1011) and an electrode ring (1012); The arc surface is arranged at the first end of the end cap (1011), the electrode ring (1012) is fixedly connected to the second end of the end cap (1011), and after the electrode ring (1012) is connected to the second end of the end cap (1011), the polymer end mounting position is formed between the electrode ring (1012) and the end cap (1011); The traction structure mounting position is arranged at the second end of the end cap (1011).

17. The flexible electrode pulse ablation catheter according to any one of claims 1 to 6, characterized in that: The hardness of the tube body (20) gradually decreases from the proximal end of the tube body (20) to the distal end of the tube body (20).

18. The flexible electrode pulse ablation catheter according to any one of claims 1 to 6, characterized in that: The tube body (20) is made of a material having a developing function.

19. The flexible electrode pulse ablation catheter according to claim 17, characterized in that: Along the radial direction of the conveying pipe assembly, the conveying pipe assembly is provided with an insulating pipe (202), a channel pipe (203), an outer conduit (204) and a stress pipe (205) in sequence; The first end of the outer catheter (204) is fixedly connected to the electrode assembly (10), the second end of the outer catheter (204) can be fixedly connected to the handle assembly (30), and the stress tube (205) is arranged at the connection position between the outer catheter (204) and the handle assembly (30); Part of the wire electrically connected to the electrode (102) can extend into the insulating tube (202), and the insulating tube (202) is used to isolate the wire electrically connected to the adjacent electrode (102); There is a gap between the inner wall of the channel tube (203) and the outer wall of the insulating tube (202), and one end of the channel tube (203) is connected to the electrode assembly (10) so as to guide the liquid to the position of the electrode assembly (10) through the channel tube (203).

20. The flexible electrode pulse ablation catheter according to any one of claims 1 to 6, characterized in that: It also includes at least one position detection device (40), wherein the at least one position detection device (40) is arranged inside the electrode (102) and fixedly arranged on the traction structure (201).

21. A pulse ablation device, characterized in that: A handle assembly (30) comprising a flexible electrode pulse ablation catheter as described in any one of claims 1 to 20; The first end of the handle assembly (30) can be electrically connected to an ablation mechanism that emits ablation energy; One end of the delivery tube assembly is fixedly connected to the second end of the handle assembly (30), and one end of the traction structure (201) passes through the delivery tube assembly and is drivingly connected to the handle assembly (30). The handle assembly (30) can drive the traction structure (201) to reciprocate relative to the delivery tube assembly along the axial direction of the delivery tube assembly.

22. The pulse ablation device according to claim 21, characterized in that: The handle assembly (30) comprises at least two wires, a rotating wheel mechanism (301) and a connector assembly (302); The rotating wheel mechanism (301) is fixedly connected to one end of the traction structure (201), and under the action of an external force, the rotating wheel mechanism (301) drives the traction structure (201) to reciprocate relative to the conveying pipe assembly along the axial direction of the conveying pipe assembly; The first ends of the at least two wires are electrically connected to the connector assembly (302), the connector assembly (302) is located at the first end of the handle assembly (30), and the connector assembly (302) is electrically connected to the ablation mechanism; The second ends of the at least two wires are electrically connected to the at least two electrodes (102) respectively, so that the positive and negative polarities of two adjacent electrodes (102) are opposite.

23. A pulse ablation device, characterized in that: comprising an ablation mechanism and a pulse ablation device as described in any one of claims 21-22; The ablation mechanism is used to provide at least one pulse group (50) to the pulse ablation device.

24. The pulse ablation device according to claim 23, characterized in that: The pulse group (50) ensures at least one high-frequency high-voltage sub-pulse (501) and / or one low-frequency low-voltage sub-pulse (502), wherein the high-frequency high-voltage sub-pulse (501) is a bipolar pulse, and the low-frequency low-voltage sub-pulse (502) is a unipolar pulse or a bipolar pulse; wherein the bipolar pulse includes a positive pulse amplitude and a negative pulse amplitude.

25. The pulse ablation device according to claim 24, characterized in that: The pulse group (50) satisfies at least one of the following characteristics: The voltage amplitude range of the bipolar pulse of the high-frequency high-voltage sub-pulse (501) is 2000V-70000V; The bipolar pulse of the high-frequency and high-voltage sub-pulse (501) has a pulse width of 50ns-50000ns; The number of bipolar pulses of the high-frequency and high-voltage sub-pulses (501) is 1-5000; The amplitude voltage of the unipolar pulse and the amplitude voltage of the bipolar pulse of the low-frequency and low-voltage sub-pulse (502) are 200V-3000V; The pulse width of the unipolar pulse and the pulse width of the bipolar pulse of the low-frequency and low-voltage sub-pulses (502) are 10 μs-500 μs; The number of unipolar pulses and the number of bipolar pulses of the low-frequency and low-voltage sub-pulses (502) are 1-5000; The number of the pulse groups (50) is 1-5000.

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