Pulse ablation device

Abstract

The invention relates to the technical field of ablation, in particular to a pulse ablation device which comprises an electrode assembly. A handle assembly; the tube body assembly comprises a supporting section and a bent section used for containing the electrode assembly, and the near end of the supporting section is connected with the handle assembly; the first driving assembly is arranged on the handle assembly, the first driving assembly is in transmission connection with the bending section, and the first driving assembly can drive the bending section to bend towards the near end of the bending section; the second driving assembly is arranged on the handle assembly and is in transmission connection with the electrode assembly, and the second driving assembly can drive the electrode assembly to move relative to the bent section and can drive the electrode assembly to contract or expand; the first driving assembly can drive the bending section to bend towards the supporting section, so that the angle of the tube body assembly can be adjusted under the driving of the first driving assembly, and the positioning precision of the tube body assembly and the position to be ablated is guaranteed; meanwhile, the second driving assembly can drive the electrode assembly to move, and more accurate conformal treatment is achieved through diameter adjustment.

Description

Technical Field

[0001] The present application relates to the technical field of ablation, and in particular to a pulse ablation device. Background Art

[0002] The pulse ablation device uses the principle of pulse ablation electric field. It mainly applies a short and high pulse voltage between two electrodes made of special materials to change the original membrane potential of the cell and produce irreversible nanoscale holes in the lipid bilayer of the membrane, destroying the homeostasis of the cell and causing cell death.

[0003] However, existing pulsed electric field ablation products used for irreversible electroporation ablation technology have many shortcomings. For example, existing pulsed ablation devices cannot freely adjust the angle of the tube body at deeper positions, resulting in some lesion locations being inaccessible, thereby reducing the ablation coverage; at the same time, the positioning accuracy of the pulsed ablation device is low and cannot adapt to complex ablation locations, which leads to a low success rate of pulsed ablation. Summary of the invention

[0004] In order to solve the above-mentioned technical problems, the first driving component in the present application can drive the bending section to bend toward the supporting section, so that the angle of the tube body component can be adjusted under the drive of the first driving component, thereby ensuring the positioning accuracy of the tube body component and the position to be ablated; at the same time, the second driving component can drive the electrode assembly to move, thereby achieving more precise conformal treatment through diameter adjustment.

[0005] The present application provides a pulse ablation device, comprising:

[0006] Electrode assembly;

[0007] Handle assembly;

[0008] A tube body assembly, comprising a support segment and a curved segment connected in sequence from a distal end to a proximal end for accommodating the electrode assembly, wherein the proximal end of the support segment is connected to the handle assembly;

[0009] A first driving assembly is disposed on the handle assembly, the first driving assembly is in driving connection with the bending section, and the first driving assembly can drive the bending section to bend toward the proximal end of the bending section;

[0010] The second driving assembly disposed on the handle assembly is transmission-connected to the electrode assembly. The second driving assembly can drive the electrode assembly to move relative to the bending section, and can drive the electrode assembly to contract or expand.

[0011] Furthermore, an image acquisition device is provided at the distal end of the curved section;

[0012] The electrode assembly is arranged within the field of view of the image acquisition device, and the image acquisition device is used to acquire image information of the position to be ablated and image information of the electrode assembly.

[0013] Further, it also includes at least one light source assembly;

[0014] The illumination range of the at least one light source assembly at least partially covers the field of view of the image acquisition device.

[0015] Further, the electrode assembly comprises an electrode, and the electrode is a tubular structure having a cavity inside;

[0016] Driven by the second driving assembly, the two opposite ends of the electrode move toward each other until the tubular structure is expanded, or the two opposite ends of the electrode move away from each other until the tubular structure is contracted.

[0017] Furthermore, the electrode assembly further comprises an inner tube and an outer tube sleeved on the inner tube, and the tube body assembly is sleeved on the outer tube;

[0018] The distal end of the electrode is fixedly connected to the distal end of the inner tube, and the proximal end of the electrode is fixedly connected to the outer tube;

[0019] Driven by the second driving assembly, the inner tube can move relative to the outer tube to adjust the distance between the two opposite ends of the electrode.

[0020] Furthermore, when the electrode is retracted into the curved section, the distance between the distal end of the electrode and the distal end of the tube assembly is 4-8 mm.

[0021] Furthermore, the electrode assembly further comprises a first fixing member and a second fixing member, wherein the first fixing member is arranged at a distal end of the electrode assembly, and the second fixing member is arranged at a proximal end of the electrode assembly;

[0022] The first fixing member and the second fixing member are respectively arranged at two ends of the electrode, and the electrode is fixedly connected to the outer tube through the second fixing member.

[0023] Further, the second driving assembly includes a pushing assembly and a pulling assembly;

[0024] The first end of the pushing assembly is fixedly connected to the outer tube of the electrode assembly, and the pushing assembly can drive the electrode assembly to move back and forth relative to the curved section;

[0025] The second end of the pushing assembly can be slidably connected to the pulling assembly, and the pulling assembly is fixedly connected to the inner tube of the electrode assembly; the pulling assembly can drive the inner tube to move relative to the outer tube to adjust the distance between the opposite ends of the electrode.

[0026] Furthermore, the second driving assembly further comprises a limit assembly, and the limit assembly can switch between a limit state and a free state;

[0027] When the limiting component is in the limiting state, the limiting component can limit the movement of the pushing component;

[0028] When the limiting assembly is in the free state, the pushing assembly can move relative to the limiting assembly.

[0029] Further, the handle assembly is provided with a receiving area, and the receiving area is used to receive the pushing assembly and the pulling assembly;

[0030] Either the accommodating area or the pushing assembly is provided with a slide rail, and the other is provided with a slider matched with the slide rail, and the pushing assembly is slidably connected with the handle assembly.

[0031] Furthermore, the pulling assembly comprises a pulling wire and a pulling member, and two ends of the pulling wire are fixedly connected to the inner tube and the pulling member respectively;

[0032] The pulling member is transmission-connected to the pushing assembly. When the pushing assembly is restricted from moving, the pulling member can slide relative to the pushing assembly. The pulling member can drive the inner tube to move relative to the outer tube through the pull wire to adjust the distance between the two opposite ends of the electrode.

[0033] Further, it also includes a rotating member and a rotating shaft;

[0034] The rotating member is sleeved on the rotating shaft, and one end of the rotating shaft can be fixedly connected to the handle assembly;

[0035] The rotating member is fixedly connected to the proximal end of the supporting section, and the proximal end of the supporting section is rotatably connected to the handle assembly via the rotating member.

[0036] Further, the first driving assembly includes a traction structure and a traction assembly fixedly disposed on the handle assembly;

[0037] At least two force application positions are evenly spaced around the curved section, the first end of the traction structure is respectively connected to the at least two force application positions, and the second end of the traction structure is connected to the traction assembly;

[0038] The traction assembly can apply traction force to each of the force application positions respectively to drive the bending section to bend toward the supporting section in at least two directions corresponding to the at least two force application positions.

[0039] Furthermore, at least four force application positions are evenly spaced around the circumference of the bending section; the traction assembly can apply traction to each of the force application positions respectively to drive the bending section to bend toward the supporting section in at least four directions corresponding to the at least four force application positions.

[0040] Furthermore, the bending section is provided with a deformable hollow structure, and the hollow structure can provide a deformation amount for the bending section to bend toward the supporting section.

[0041] Furthermore, the hollow structure includes at least one of a thread-shaped groove structure, a grid-shaped groove structure, a grid hollow structure or a corrugated groove structure.

[0042] Furthermore, the hollow structure includes a grid hollow structure, and adjacent grid units in the grid hollow structure are rotationally connected.

[0043] Implementing the embodiments of the present application has the following beneficial effects:

[0044] The present application sets up an electrode assembly, a tube assembly, a first drive assembly and a second drive assembly that cooperate with each other, so that the first drive assembly can drive the bending section to bend toward the supporting section, so that the angle of the tube assembly can be freely adjusted under the drive of the first drive assembly, thereby ensuring the positioning accuracy of the tube assembly and the position to be ablated, and can also enter complex positions to be ablated by controlling the angle of the tube assembly, thereby improving the adaptation range of ablation; at the same time, it also realizes that the second drive assembly can drive the electrode assembly to move relative to the bending section, and the second drive assembly can drive the electrode assembly to contract or expand, so as to achieve more precise conformal treatment of lesions with irregular shapes or positions through diameter adjustment, avoiding insufficient ablation range due to too small an electrode or unnecessary normal tissue damage due to too large an electrode; and optimizing operating efficiency, reducing the complexity and operating difficulty of surgical equipment, thereby improving the success rate of electrode delivery and surgical safety, thereby further improving the success rate of ablation. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] 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.

[0046] Figure 1This is a structural diagram of the pulse ablation device in the case where the electrode assembly of this embodiment extends out of the curved section;

[0047] Figure 2 This is a structural diagram of the pulse ablation device when the electrode assembly of this embodiment is retracted to the curved section;

[0048] Figure 3 is a structural diagram of the electrode assembly, the pushing assembly and the pulling assembly in this embodiment after being connected;

[0049] Figure 4 is a structural diagram of the image acquisition device, the light source assembly and the tube assembly in this embodiment after being connected;

[0050] Figure 5 This is a structural diagram of the electrode assembly in this embodiment in a contracted state;

[0051] Figure 6 is a structural diagram of the electrode assembly in this embodiment in an unfolded state;

[0052] Figure 7 2 is a structural diagram of the bending section described in this embodiment.

[0053] Among them, the reference numerals in the figure correspond to:

[0054] 1-image acquisition device; 2-electrode assembly; 3-tube body assembly; 4-handle assembly; 5-light source assembly; 201-electrode; 202-second fixing member; 203-outer tube; 204-inner tube; 301-bending section; 302-supporting section; 303-instrument channel; 401-rotating member; 402-pushing assembly; 403-pulling assembly; 404-traction assembly; 405-gripping portion; 406-traction structure; 407-limiting assembly; 3011-rotating shaft; 4031-pull wire; 4032-pulling member. DETAILED DESCRIPTION

[0055] 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.

[0056] 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.

[0057] See attached Figure 1-7 The present embodiment provides a pulse ablation device, comprising: an electrode assembly 2; a handle assembly 4; a tube assembly 3, comprising a support segment 302 and a curved segment 301 for accommodating the electrode assembly 2, which are sequentially connected from the distal end to the proximal end, and the proximal end of the support segment 302 is connected to the handle assembly 4; a first drive assembly is arranged on the handle assembly 4, the first drive assembly is transmission-connected to the curved segment 301, and the first drive assembly can drive the curved segment 301 to bend toward the proximal end of the curved segment 301; a second drive assembly is arranged on the handle assembly 4, and is transmission-connected to the electrode assembly 2, and the second drive assembly can drive the electrode assembly 2 to move relative to the curved segment 301, and can drive the electrode assembly 2 to contract or expand.

[0058] It should be noted that: in this embodiment, by setting up the electrode assembly 2, the tube assembly 3, the first drive assembly and the second drive assembly that cooperate with each other, the first drive assembly can drive the bending section 301 to bend toward the supporting section 302, so that the angle of the tube assembly 3 can be freely adjusted under the drive of the first drive assembly, thereby ensuring the positioning accuracy of the tube assembly 3 and the position to be ablated, and can also enter a complex position to be ablated by controlling the angle of the tube assembly 3, thereby improving the adaptation range of ablation; at the same time, it is also realized that the second drive assembly can drive the electrode assembly 2 to move relative to the bending section 301, and the second drive assembly can drive the electrode assembly 2 to shrink or expand, so as to achieve more precise conformal treatment of lesions with irregular shapes or positions through diameter adjustment, avoiding insufficient ablation range due to too small an electrode or unnecessary normal tissue damage due to too large an electrode; and optimizing operating efficiency, reducing the complexity and operating difficulty of surgical equipment, thereby improving the success rate of electrode delivery and surgical safety, thereby further improving the success rate of ablation.

[0059] In this embodiment, when the tube assembly 3 reaches the position to be ablated, the pushing assembly 402 controls the electrode assembly 2 to push forward a fixed distance. When the electrode assembly 2 and the tube assembly 3 need to be bent, the bending adjustment of the distal end of the tube assembly 3 is operated by the pulling assembly 404 until the relevant area is input; when the electrode assembly 2 needs to be unfolded, the pulling assembly 403 drives the inner tube 204 to move relative to the outer tube 203, so that the electrode 201 in the electrode assembly 2 is unfolded to expand the ablation area between the electrode 201 and the position to be ablated.

[0060] Specifically, the tube body assembly 3 in the pulse ablation device can be positioned at the position to be ablated. Before positioning, the distal end of the tube body assembly 3 is bent by operating the traction assembly 404 to achieve precise positioning of the tube body assembly 3 and the position to be ablated. After the electrode 201 extends out of the curved section 301, if the electrode 201 needs to adjust its relative position with the position to be ablated, the distal end of the tube body assembly 3 can be bent by operating the traction assembly 404, thereby driving the electrode 201 to bend, thereby achieving position adjustment between the electrode 201 and the position to be ablated.

[0061] After the tube body assembly 3 is positioned, the electrode assembly 2 can extend out of the curved section 301, and the electrode assembly 2 is unfolded to adapt to the area of ​​the position to be ablated, so that the electrode assembly 2 is in close contact with a large area of ​​the position to be ablated, thereby ensuring the pulse ablation effect of the electrode assembly 2 on the position to be ablated; for ease of understanding, the pulse ablation device is introduced in the following description by taking the example of delivering the electrode assembly 2 to the peripheral bronchus to treat malignant lung nodules. The electrode assembly 2 in this embodiment is configured to transmit pulse energy to the target lesion for irreversible electroporation ablation; the electrode assembly 2 is configured so that at least one electrode 201 contacts the lesion tissue; wherein, when only one electrode 201 contacts the lesion, an energy release loop is formed with the body surface electrode 201 to achieve local irreversible electroporation ablation of small lesions; when at least two adjacent electrodes 201 can contact the lesion, bipolar ablation can be achieved, that is, the pulsed electric field is transmitted through adjacent electrodes of opposite sex; optionally, the electrode assembly 2 is composed of a distal electrode 201 and a proximal electrode 201; the distal electrode 201 and the proximal electrode 201 are arranged axially at intervals along the tube body assembly 3; the exterior of the distal electrode 201 and the proximal electrode 201 are conductive surfaces; the distal electrode 201 and / or the proximal electrode 201 can be expanded from a tubular shape to an ellipsoid or a spindle shape to more fully contact the lesion tissue and improve the pulse energy delivery effect.

[0062] When the pulse ablation device is used to deliver the electrode assembly 2 through the bronchoscope, the electrode assembly 2 and the tube assembly 3 are inserted into the bronchoscope channel; then, the electrode assembly 2 is guided to the lesion site with the help of positioning technology such as electromagnetic navigation, and the electrode assembly 2 is delivered into the lesion, and then the electrode assembly 2 is controlled by the pulse ablation device to achieve radial expansion and / or radial bending of the electrode 201, so that the electrode assembly 2 is fully in contact with the lesion tissue, reducing the loss of the pulse electric field transmission caused by media such as air, mucus, and blood; finally, the relative position of the electrode assembly 2 and the lesion is confirmed by CT imaging and / or image acquisition device 1 and the pulse electric field ablation operation is performed; optionally, if the lesion location is not confirmed before the operation, it can also be delivered in conjunction with a guide sheath, and the electromagnetic navigation and / or image acquisition device 1 is used to pre-push the adapted guide sheath to the vicinity of the lesion, the tube assembly 3 is positioned with the lesion, the electrode assembly 2 is controlled to extend the curved section 301, and the electrode 201 in the electrode assembly 2 is controlled to unfold to fit the lesion, and the unfolded electrode 201 is controlled to ablate the lesion.

[0063] In this embodiment, the tube body assembly 3 has a distal end and a proximal end that are relatively set, the distal end of the curved section 301 is at the same position as the distal end of the tube body assembly 3, the distal end of the support section 302 is fixedly connected to the proximal end of the curved section 301, and the proximal end of the support section 302 is at the same position as the proximal end of the tube body assembly; the electrode 201 has a distal end and a proximal end that are relatively set, and when the electrode 201 is retracted in the curved section 301, the distal end of the electrode 201 is close to the distal end of the curved section 301, and the proximal end of the electrode 201 is far away from the distal end of the curved section 301.

[0064] In this embodiment, the pulse ablation device is mainly used for tumor ablation treatment, especially for tumors that are difficult to observe or irregular. The electrode assembly 2 arranged at the distal end of the tube body assembly 3 can be extended into the diseased tissue, and the outer surface of the electrode assembly 2 is abutted against the diseased tissue. The pushing assembly 402 and the pulling assembly 403 drive the movement of the electrode assembly 2 and adjust the diameter of the electrode assembly 2 to improve the electrode pulse energy transmission efficiency and prevent the electrode assembly 2 from shifting during the ablation process. At the same time, the electrode assembly 2 can also adapt to lesions of different shapes or sizes, so that the electrode assembly 2 in this embodiment, driven by the pushing assembly 402 and the pulling assembly 403, can perform pulse ablation on tumors that are difficult to observe or irregular, while ensuring the ablation effect.

[0065] Preferably, the pulse formed by the electrode assembly 2 can emit pulses with a width of microns or nanoseconds to the pulmonary diseased tissue, so as to damage the stability of the surface of the diseased tissue cell membrane and cause multiple hydrophilic micropores to appear on the surface of the diseased tissue cells, thereby destroying the homeostasis of the diseased tissue cells and causing the diseased tissue cells to die, thereby achieving the therapeutic effect of pulse ablation of the diseased tissue.

[0066] It is understandable that different diseased tissue cells have different destruction thresholds. By controlling the size of the pulse energy emitted by the electrode assembly 2, the pulse emitted by the electrode assembly 2 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 the electrode assembly 2 corresponding to the diseased tissue cells, the pulse only performs pulse ablation treatment on the diseased tissue cells without destroying other tissue cells, thereby ensuring the safety of ablation to a certain extent.

[0067] In some possible embodiments, an image acquisition device 1 is provided at the distal end of the curved section 301; the electrode assembly 2 is arranged within the field of view of the image acquisition device 1, and the image acquisition device 1 is used to acquire image information of the position to be ablated and image information of the electrode assembly 2. By arranging the image acquisition device 1 at the distal end of the tube body assembly 3, it is possible to obtain image information of the position to be ablated, image information of the distal end of the tube body assembly 3, and image information of the electrode assembly 2. Such a configuration enables the image acquisition device 1 to provide real-time visual monitoring, thereby improving the accuracy and safety of the ablation operation.

[0068] In this embodiment, the image acquisition device 1 is used to obtain image information of surrounding tissues, and the above-mentioned image information is at least one of picture information or video information. By setting up the image acquisition device 1, it is convenient for users to directly observe the lesion area, reduce reliance on indirect guidance of traditional imaging equipment (such as CT or ultrasound), and thus improve the safety and accuracy of pulse treatment; the image acquisition device 1 is arranged at the end of the tube body assembly 3 or near the end. Preferably, the image acquisition device 1 is arranged on the end face of the distal end of the curved section 301.

[0069] In this embodiment, the image acquisition device 1 is a device capable of acquiring images, such as a camera or a miniature camera; at least one image acquisition device 1 is disposed at the distal end of the curved section 301, and the image acquisition device 1 can be disposed on the end surface of the curved section 301 or on the side wall of the curved section 301, as long as the image acquisition device 1 can acquire image information of the distal end of the curved section 301 in real time.

[0070] In some possible embodiments, at least one light source assembly 5 is further included; the illumination range of at least one light source assembly 5 at least partially covers the field of view of the image acquisition device 1. By making the illumination range of the light source assembly 5 at least partially cover the field of view of the image acquisition device 1, the image acquisition quality of the image acquisition device 1 can be ensured, and clearer and more accurate images can be obtained, thereby improving the operating accuracy of the equipment, thereby improving the accuracy and safety of the ablation operation.

[0071] In this embodiment, the light source assembly 5 is distributed around the image acquisition device 1 to provide lighting in a low-light environment to ensure a clear field of vision. The light source assembly 5 is preferably a light-guiding optical fiber or an LED light source. The instrument channel 303 and the electrode assembly 2 are coaxial structures with a gap therebetween, which can ensure that the electrode assembly 2 can be pushed smoothly in the instrument channel while leaving a certain gap for air circulation.

[0072] In this embodiment, the pulse ablation device further includes a controller, and the image acquisition device 1 and the light source assembly 5 are in communication connection with the controller, and the controller can control the opening and closing of the image acquisition device 1 and the light source assembly 5 .

[0073] In some possible embodiments, the electrode assembly 2 includes an electrode 201, which is a tubular structure with a cavity inside; driven by the second driving assembly, the opposite ends of the electrode 201 move toward each other until the tubular structure expands, or the opposite ends of the electrode 201 move away from each other until the tubular structure contracts. By setting the electrode 201 as a structure with variable diameter, more precise conformal treatment can be achieved for lesions with irregular shapes or positions through diameter adjustment, avoiding insufficient ablation range due to too small an electrode or unnecessary normal tissue damage due to too large an electrode, thereby ensuring the ablation area and improving the ablation effect.

[0074] In this embodiment, the electrode 201 in the electrode assembly 2 can be contracted or expanded, that is, the outer diameter of the electrode assembly 2 can be extended and deformed to adapt to lesions of different sizes; the conductor part in the electrode 201 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.

[0075] In this embodiment, when the electrode 201 is in a contracted state, the cross section of the electrode 201 is cylindrical; when the electrode 201 is in an expanded state, the cross section of the electrode 201 is elliptical.

[0076] Specifically, in order to achieve the expected expanded shape of the electrode assembly 2, the electrode assembly 2 is initially a cylindrical structure and / or a tubular structure, etc.; the head end of the electrode 201 is preferably arc-shaped or conical, so as to facilitate penetrating into the narrower sections of the bronchus and the inside of the lesion; in order to better fit the peripheral bronchial lesions, increase the effective contact area of ​​the electrode, and achieve a larger radial ablation range, the electrode assembly 2 is an expandable structure, such as a woven mesh structure, a sac structure, a spline structure, etc.; the initial diameter of the electrode 201 is preferably φ1.0mm to φ2.8mm, and the diameter after expansion is preferably φ2.0mm to φ20mm.

[0077] In this embodiment, the electrode 201 is a tubular structure woven from metal wires; and / or, the electrode 201 is a tubular structure formed by at least two simply supported beams circumferentially spaced around the distal end of the tube body assembly 3; wherein, along the length direction of the simply supported beams, the surface slope of the simply supported beams gradually changes from small to large, and then gradually changes from large to small, so as to form an arch structure; the electrode 201 is woven from metal wires in a weaving manner of one-on-one, one-on-two, or two-on-two.

[0078] In this embodiment, when the electrode 201 is in a compressed state, the length direction of the simply supported beam is parallel to the axial direction of the tube body assembly 3, and the thickness direction of the simply supported beam passes through the axis of the tube body assembly 3. The simply supported beam satisfies at least one of the following characteristics: the thickness of the simply supported beam is much smaller than the width of the simply supported beam; the width of the simply supported beam is much smaller than the length of the simply supported beam; the number of simply supported beams is 2-14.

[0079] In some possible embodiments, the electrode assembly 2 also includes an inner tube 204 and an outer tube 203 sleeved on the inner tube 204, and the tube body assembly 3 is sleeved on the outer tube 203; the distal end of the electrode 201 is fixedly connected to the distal end of the inner tube 204, and the proximal end of the electrode 201 is fixedly connected to the outer tube 203; driven by the second driving assembly, the inner tube 204 can move relative to the outer tube 203 to adjust the distance between the opposite ends of the electrode 201. By setting the electrodes 201, the outer tube 203 and the inner tube 204 that cooperate with each other, the distal end of the electrode 201 can be driven by the inner tube 204 to move toward the proximal end of the electrode 201, thereby adjusting the distance between the opposite ends of the electrode 201, ensuring that the diameter of the electrode 201 is quickly adjusted, and then quickly achieving precise conformal treatment, that is, ensuring the ablation area to improve the ablation effect.

[0080] In this embodiment, when the outer tube 203 is fixed relative to the tube body assembly 3 , the inner tube 204 can drive the distal end of the electrode 201 to move toward the proximal end of the electrode 201 , thereby realizing the deployment of the electrode 201 .

[0081] In this embodiment, the outer tube 203 is sleeved on the inner tube 204, and there is a gap between the outer tube 203 and the inner tube 204 to facilitate air circulation.

[0082] In this embodiment, the tube body component 3 is configured to deliver the image acquisition device 1 and the electrode component 2 to the target lesion area. The hardness of the tube body component 3 gradually decreases from the proximal end of the tube body component 3 to the distal end of the tube body component 3. The material of the tube body component 3 is at least one of polyetheramide, nylon, thermoplastic polyurethane, polytetrafluoroethylene, silicone or fluororubber, etc., so that the distal end of the tube body component 3 can be delivered in a curved or forked lumen. The supporting capacity of the proximal end of the tube body component 3 ensures that the tube body component 3 is smoothly delivered to the target lesion area.

[0083] In some possible embodiments, when the hardness of the tube body assembly 3 gradually changes, the hardness of the inner tube 204 in the electrode assembly 2 gradually decreases from the proximal end of the tube body assembly 3 to the distal end of the tube body assembly 3, and / or the hardness of the outer tube 203 in the electrode assembly 2 gradually decreases from the proximal end of the tube body assembly 3 to the distal end of the tube body assembly 3.

[0084] In some possible embodiments, when the electrode 201 is retracted into the curved section 301, the distance between the distal end of the electrode 201 and the distal end of the tube body assembly 3 is 4-8 mm. By setting as above, it can be ensured that when the tube body assembly 3 is positioned, the electrode 201 arranged therein will not interfere with the position to be ablated and affect the positioning accuracy. That is, the above setting can ensure the positioning accuracy of the tube body assembly 3 and the position to be ablated.

[0085] In this embodiment, the excitation part of the electrode assembly 2 is entirely within the curved section 301 of the tube assembly 2, and the electrode assembly 2 can bend in multiple directions along with the curved section 301 of the tube assembly 3. After approaching the position to be ablated, the pushing assembly 402 disposed on the handle assembly 4 is controlled to push the electrode assembly 2 forward to the extended curved section 301, and then the pulling assembly 403 is controlled to expand the electrode 201 to abut against the position to be ablated for ablation.

[0086] Preferably, the distal end of the electrode assembly 2 is spaced 5 mm from the distal end of the tube assembly 3 .

[0087] In some possible embodiments, the electrode assembly 2 also includes a first fixing member and a second fixing member 202, the first fixing member is arranged at the distal end of the electrode assembly 2, and the second fixing member 202 is arranged at the proximal end of the electrode assembly 2; the first fixing member and the second fixing member 202 are respectively arranged at both ends of the electrode 201, and the electrode 201 is fixedly connected to the outer tube 203 through the second fixing member 202. By setting the first fixing member and the second fixing member 202, the electrode 201 can be fixed, thereby ensuring the structural stability of the electrode 201 during the contraction or expansion process; at the same time, the first fixing member is set at the distal end of the electrode 201, which can prevent the electrode 201 from piercing the position to be ablated, thereby ensuring the safety of the ablation process.

[0088] In some possible embodiments, the material of the first fixing member and the second fixing member 202 is a developing material. Such a setting can intuitively show the shape of the electrode 201. In the event of a failure of the image acquisition device 1, the pulse ablation device can still work, thereby ensuring the safety of the ablation process and ensuring the stability of the operation of the pulse ablation device.

[0089] In this embodiment, the distal end of the first fixing member disposed at the distal end of the electrode 201 is in an arc shape or a cone shape, which can facilitate the electrode 201 to enter the position to be ablated.

[0090] In some possible embodiments, the electrode assembly 201 includes at least two electrodes 201, and the at least two electrodes 201 are arranged in sequence from the distal end of the tube body assembly 3 to the proximal end of the tube body assembly 3, and the two adjacent electrodes 201 are fixedly connected; the distal end of the electrode 201 close to the distal end of the electrode assembly 2 is fixedly connected to the inner tube 204, and the proximal end of the electrode 201 close to the proximal end of the electrode assembly 2 is fixedly connected to the outer tube 203, so that the inner tube 204 of at least two electrodes 201 can be synchronously contracted or expanded; by setting at least two electrodes 201, the pulse ablation area can be increased, and at the same time, the polarities passed through the two adjacent electrodes 201 are opposite, that is, the two adjacent electrodes 201 can achieve bipolar ablation of the ablation position to be treated, thereby improving the ablation effect and efficiency, and thereby improving the success rate of pulse ablation.

[0091] In some possible embodiments, the second driving assembly includes a pushing assembly 402 and a pulling assembly 403; the first end of the pushing assembly 402 is fixedly connected to the outer tube 203 of the electrode assembly 2, and the pushing assembly 402 can drive the electrode assembly 2 to reciprocate relative to the curved section 301; the second end of the pushing assembly 402 can be slidably connected to the pulling assembly 403, and the pulling assembly 403 is fixedly connected to the inner tube 204 of the electrode assembly 2; the pulling assembly 403 can drive the inner tube 204 to move relative to the outer tube 203 to adjust the distance between the two opposite ends of the electrode 201, and the pushing assembly 402 can be matched with each other. The moving component 402 and the pulling component 403 can realize that after the tube body component 3 is positioned at the position to be ablated, the pushing component 402 can drive the electrode component 2 to extend the curved section 301, thereby realizing precise contact between the electrode component 2 and the position to be ablated, and preliminarily ensuring the ablation effect; the pulling component 403 can pull the inner tube 204 of the electrode component 2, and can adjust the distance between the two opposite ends of the electrode 201, thereby realizing the adjustment of the diameter of the electrode 201, thereby achieving the adjustment of the ablation area of ​​the electrode 201, realizing the expansion of the ablation area where the electrode 201 is in contact with the lesion, ensuring the ablation effect, and improving the ablation success rate.

[0092] In this embodiment, the push rod assembly 402 and the pull rod assembly 403 are located in the middle part of the handle housing, and are used for pushing the electrode assembly 3 as a whole and opening and closing the electrode parts.

[0093] In some possible embodiments, the second driving component also includes a limit component 407, and the limit component 407 can switch between a limit state and a free state; when the limit component 407 is in the limit state, the limit component 407 can limit the movement of the pushing component 402; when the limit component 407 is in the free state, the pushing component 402 can move relative to the limit component 407. By setting the limit component 407, the pushing component 402 can be limited. Without controlling the overall movement of the electrode assembly 2 relative to the tube body assembly 3, that is, after the electrode assembly 2 is positioned with the position to be ablated, the limit component 407 can limit the pushing component 402 to avoid the movement of the pushing component 402 and affect the positioning accuracy, thereby ensuring the ablation effect and improving the ablation success rate.

[0094] In this embodiment, the limiting component 407 is protruded from the handle component 4, and the user can directly apply external force to the limiting component 407 to drive the limiting component 407 to move.

[0095] In this embodiment, the specific structure of the limiting component 407 is not limited, as long as the limiting component 407 can limit the pushing component 402.

[0096] Preferably, the limiting component 407 is a nut, and the limiting component 407 is threadedly connected to the pushing component 402 to limit the pushing component 402.

[0097] In some possible embodiments, a first protrusion structure is provided on the side of the pushing component 402 facing the electrode component 2, and the first protrusion structure is provided with an external thread. A second protrusion structure is provided on the side facing the electrode component 2 in the accommodating area of ​​the handle component 4, and the second protrusion structure is provided with an external thread. The first protrusion structure and the second protrusion structure are abutted against each other to form a cylindrical protrusion, and the cylindrical protrusion is provided with an external thread. The nut fixes the handle component 4, the pushing component 402 and the limiting component 407 through the cylindrical protrusion.

[0098] In other possible embodiments, the limiting component 407 is a nut, the inner wall and the outer wall of the nut are both threaded, the nut is sleeved on the connecting shaft and threadedly connected to the connecting shaft, the connecting shaft is fixedly connected to the handle housing, and one end of the connecting shaft is connected to the pushing component 402, when the pushing component 402 is not limited by the limiting component 407, the pushing component 402 can move relative to the connecting shaft, and the limiting component 407 can rotate relative to the connecting shaft; the pushing component 402 is provided with a connecting boss, the connecting boss is coaxially arranged with the connecting shaft, and the inner wall of the connecting boss is provided with an internal thread matching the external thread of the nut; when the pushing component 402 is limited by the limiting component 407, the nut is sleeved on the connecting shaft, and the external thread of the nut is threadedly connected to the internal thread of the connecting protrusion, so as to realize the relative fixation of the pushing component 402, the limiting component 407 and the connecting shaft.

[0099] In some possible embodiments, the handle assembly 4 is provided with a accommodating area, and the accommodating area is used to accommodate the pushing assembly 402 and the pulling assembly 403; either the accommodating area or the pushing assembly 402 is provided with a slide rail, and the other is provided with a slider matching the slide rail, and the pushing assembly 402 is slidably connected to the handle assembly 4. By arranging both the pushing assembly 402 and the pulling assembly 403 in the accommodating area of ​​the handle assembly 4, the installation stability of the pushing assembly 402 and the pulling assembly 403 can be guaranteed, and the handle assembly 4 and the pushing assembly 402 cooperate with each other through the slide rail and the slider, which can ensure the stability of the operation of the pushing assembly 402, and can further ensure the installation stability of the pushing assembly 402 and the pulling assembly 403.

[0100] In this embodiment, the handle assembly 4 also includes a handle shell, and a accommodating area is arranged on the handle shell. The pushing assembly 402 and the pulling assembly 403 are arranged behind the accommodating area, and are partially protruded on the handle shell; a gripping portion 405 is arranged on the side of the handle shell away from the electrode assembly 2. The gripping portion 405 can be easily held by the user, thereby ensuring the stability of the pulse ablation device during ablation.

[0101] In this embodiment, the pushing component 402 is a shell with an opening on one side, the pushing component 402 is provided with a first mounting hole, the pulling component 403 is provided with a second mounting hole, and the first mounting hole and the second mounting hole are coaxially arranged; the proximal end of the outer tube 203 in the electrode assembly 2 is installed in the first mounting hole, and the proximal end of the inner tube 204 in the electrode assembly 2 passes through the first mounting hole and the second mounting hole in sequence.

[0102] In this embodiment, a slider is provided on the outer wall of the pushing component 402, and a corresponding slide rail is provided in the accommodating area. The pushing component 402 moves relative to the handle shell, and the arrangement direction of the slide rail is consistent with the direction from the distal end to the proximal end of the tube body component 3. Preferably, sliders are provided on both sides of the opposite sides of the pushing component 402, which can improve the stability of the sliding connection between the pushing component 402 and the handle component 4.

[0103] In this embodiment, the length of the slide rail is not limited, as long as the pushing component 402 can slide with the slide rail when driving the electrode component 2 to move between its first extreme position and the second extreme position.

[0104] In some possible embodiments, the pulling assembly 403 includes a pulling wire 4031 and a pulling member 4032, and the two ends of the pulling wire 4031 are fixedly connected to the inner tube 204 and the pulling member 4032 respectively; the pulling member 4032 is transmission-connected to the pushing assembly 402, and when the pushing assembly 402 is restricted from moving, the pulling member 4032 can slide relative to the pushing assembly 402, and the pulling member 4032 can drive the inner tube 204 to move relative to the outer tube 203 through the pulling wire 4031, so as to adjust the distance between the two opposite ends of the electrode 201. The pushing component 402 and the pulling member 4032 that cooperate with each other can realize that the pulling member 4032 can move relative to the pushing component 402 under the action of external force, and the pulling member 4032 can be stationary relative to the pushing component 402 when not acted upon by external force. In this way, it can be ensured that after the pulling member 4032 pulls the electrode 201 to be unfolded through the pull wire 4031, the electrode 201 will not shrink. In this way, it can be ensured that the ablation area of ​​the electrode 201 at the to-be-ablated position will not change, thereby ensuring the ablation effect at the ablation position and improving the ablation success rate at the ablation position.

[0105] In this embodiment, the second mounting hole passes through the pulling member 4032, and the pulling member 4032 includes a connecting portion and an abutting portion connected in sequence. When the pulling member 4032 drives the inner tube 204 to move relative to the outer tube 203, the connecting portion can slide inside the pushing component 402; when the pulling component 403 is in the initial position, that is, when the inner tube 204 is not pulled, the connecting portion is completely arranged in the pushing component 402, and the abutting portion abuts against the side wall of the pushing component 402. When the pulling component 403 pulls the inner tube 204 until the diameter of the electrode 204 moves to the maximum, the pulling member 4032 drives the inner tube 204 to move toward the side away from the limiting component 407, and part of the connecting portion is arranged in the pushing component 402, and there is a gap between the limiting portion and the side wall of the pushing component 402.

[0106] In this embodiment, the connecting portion and the pushing assembly 402 are interference fit.

[0107] In this embodiment, the connection portion is fixedly connected to the inner tube 204 via a pull wire 4031 , and the pull wire 4031 is disposed in the pushing assembly 402 .

[0108] In some possible embodiments, a rotating member 401 and a rotating shaft are further included; the rotating member 401 is sleeved on the rotating shaft, and one end of the rotating shaft can be fixedly connected to the handle assembly 4; the rotating member 401 is fixedly connected to the proximal end of the support segment 302, and the proximal end of the support segment 302 is rotatably connected to the handle assembly 4 through the rotating member 401. By arranging the rotating member 401, the rotating shaft and the support segment 302 that cooperate with each other, the tube body assembly 3 can be driven by the rotating member 401 to rotate. When the tube body assembly 3 enters the position to be ablated, the distal end of the tube body assembly 3 can be rotated to facilitate entering a complex position to be ablated, thereby improving the pulse ablation range of the pulse ablation device.

[0109] In this embodiment, the rotating member 401 is a rotating ring, which is fixedly connected to the proximal end of the support section 302 , and is rotatably connected to the handle shell of the handle assembly 4 , and the rotating shaft is fixedly arranged at the distal end of the gripping portion 405 .

[0110] In some possible embodiments, the first driving assembly includes a traction structure 406 and a traction assembly 404 fixedly arranged on the handle assembly 4; at least two force-applying positions are evenly arranged at intervals on the circumference of the bending section 301, the first end of the traction structure 406 is respectively connected to the at least two force-applying positions, and the second end of the traction structure 406 is connected to the traction assembly 404; the traction assembly 404 can apply traction to each force-applying position respectively to drive the bending section 301 to bend toward the supporting section 302 in at least two directions corresponding to the at least two force-applying positions, and by setting the traction structures 406 that cooperate with each other 6 and the traction assembly 404, which can realize that the first end of the traction structure 406 is connected to at least two force application positions respectively, thereby realizing that the bending section 301 can be bent toward the support section 302 in at least two directions, thereby improving the positioning accuracy of the tube body assembly 3 and the position to be ablated, and at the same time, it can facilitate the distal end of the tube body assembly 3 to enter a complex position to be ablated, meet the needs of multi-angle operation in a complex surgical environment, so that after the tube body assembly 3 is positioned with the position to be ablated, the electrode assembly 2 can be more closely fitted to the position to be ablated after extending out of the bending section 301, thereby ensuring the ablation effect and improving the ablation success rate.

[0111] In this embodiment, the traction component 404 is arranged in the middle area of ​​the handle shell and can rotate around the rotating axis; the traction component 404 is fixed to the traction structure 406 inside, and the displacement movement of the traction structures 406 on both sides is controlled by rotation, thereby driving the bending adjustment of the distal bending part of the tube body component 3; at least two traction ends are arranged on one side of the traction structure 406 close to the force application position, and the traction ends are arranged corresponding to the force application position.

[0112] In this embodiment, the traction structure 406 is a traction rope, and the traction component 404 is a rotating wheel. A rotating shaft is provided on the rotating wheel, and the rotating wheel is rotatably connected to the rotating shaft. The rotating shaft is fixedly provided on the handle housing, and the traction rope is wound around the rotating wheel; the traction rope is wound around the rotating wheel, and the traction rope is fixedly connected to the force application positions respectively.

[0113] Specifically, there are one or two traction ropes wound around the same rotating wheel.

[0114] In this embodiment, the setting position and setting direction of the rotating wheel are not set, as long as the traction rope wound thereon is approximately parallel to the axis of the curved section 301.

[0115] In this embodiment, two force application positions are evenly spaced around the circumference of the bending section 301, and a group of traction components 404 are provided correspondingly to drive the bending section 301 to bend toward the supporting section 302 in two directions corresponding to the two force application positions.

[0116] In this embodiment, the traction assembly 404 can rotate clockwise or counterclockwise. When the traction assembly 404 rotates clockwise, the traction structure 406 applies a pulling force to a force application position and bends toward the support segment 302 in a direction corresponding to the force application position.

[0117] In some possible embodiments, at least four force-applying positions are evenly spaced around the circumference of the curved segment 301; the traction assembly 404 can apply traction force to each force-applying position, respectively, to drive the curved segment 301 to bend toward the support segment 302 in at least four directions corresponding to the at least four force-applying positions. By evenly spaced at least four force-applying positions around the circumference of the curved segment 301, the first end of the traction structure 406 can be connected to the at least four force-applying positions, respectively, so that the curved segment 301 can be bent toward the support segment 302 in at least four directions, thereby improving the positioning accuracy of the tube body assembly 3 and the position to be ablated.

[0118] In this embodiment, four force application positions are evenly spaced around the circumference of the bending section 301, and two sets of traction components 404 are required to drive the bending section 301 to bend toward the supporting section 302 in two directions corresponding to the two force application positions.

[0119] In this embodiment, both groups of traction components 404 are rotating wheels, and the structures of the two groups of traction components 404 are the same, and the only difference between the two groups is the location. The two rotating wheels do not interfere with each other during rotation, and the axes arranged on the two rotating wheels are arranged vertically, thereby ensuring that the traction rope wound thereon is approximately parallel to the axis of the curved section 301.

[0120] In this embodiment, each traction assembly 404 can rotate clockwise or counterclockwise. When the traction assembly 404 rotates clockwise, the traction structure 406 applies a pulling force to a force application position and bends toward the support segment 302 in a direction corresponding to the force application position.

[0121] In this embodiment, four force-applying positions are evenly spaced around the circumference of the curved section 301, and the angle between each force-applying position is 90 degrees. The four exemplary force-applying positions are respectively at 3 o'clock, 6 o'clock, 9 o'clock and 12 o'clock. The traction structure 406 has four traction ends, and the four traction ends are respectively fixedly connected to the force-applying positions arranged at 3 o'clock, 6 o'clock, 9 o'clock and 12 o'clock to achieve multi-angle adjustment of the curved section 301.

[0122] Exemplarily, pulling the traction end attached at the 12 o'clock position causes the curved section 301 to deflect upward, and pulling the traction end attached at the 6 o'clock position causes the curved section 301 to deflect downward; pulling the traction end attached at the 3 o'clock position causes the right front end of the curved section 301 to deflect; pulling the traction end attached at the 9 o'clock position causes the left front end of the curved section 301 to deflect.

[0123] In some possible embodiments, the bending section 301 is provided with a deformable hollow structure, which can provide a deformation amount for the bending section 301 to bend toward the supporting section 302. By providing the deformable hollow structure, the flexibility of the bending section 301 can be improved. When positioning the tube body assembly 3 and the position to be ablated, the positioning accuracy of the tube body assembly 3 and the position to be ablated can be improved by adjusting the bending angle of the bending section 301, thereby improving the ablation effect.

[0124] In some possible embodiments, the hollow structure includes at least one of a threaded groove structure, a grid groove structure, a grid hollow structure or a corrugated groove structure. By setting the above structure, the hollow structure can ensure the deformation of the bending section 301, so that the bending section 301 is not prone to material overload or breakage when bending, thereby improving the reliability and durability of the bending section 301.

[0125] In some possible embodiments, the hollow structure includes a grid hollow structure, in which adjacent grid units are rotationally connected. By rotationally connecting adjacent grid units, the rotation flexibility between adjacent grid units can be improved, thereby increasing the speed of adjusting the angle of the bending section 301 and reducing the force for controlling the bending of the bending section 301, thereby achieving a labor-saving effect.

[0126] In this embodiment, the grid hollow structure is connected by a series of pivot pins. Adjacent grid units are connected by pivot pins. Each pivot pin is connected to an adjacent pivot pin.

[0127] The axis is offset by 90 degrees; the grid unit is a quadrilateral structure, and the four vertices of the four deformation structures are provided with pivot pins; each pivot pin is offset by 90 degrees from the adjacent pivot, and the two pivot pins of the first group of grid units that are relatively arranged allow the grid unit to curl in the up and down directions. The two pivot pins of the second group that are relatively arranged allow the grid unit to curl in the left and right directions. In this way, the grid hollow structure with multiple grid units, that is, the bending section 301, can be curled in any direction under the action of the above-mentioned grid units and pivot pins. The bending section 301 is bent toward the support section 302 at the far end by pulling the traction structure 406 at different positions.

[0128] The following is a detailed description of the method for using the pulse ablation device with visual and adjustable bend navigation, specifically the process and method of performing lung positioning ablation using the pulse ablation device under real-time visual guidance.

[0129] Step S10: Imaging examination: Before treatment, obtain the patient's chest CT or MRI imaging data to understand the bronchial anatomical structure, measure the location, size, shape and other information of the nodules;

[0130] Step S20: Image analysis and planning: Use the acquired CT or MRI images to analyze the location of the tumor and surrounding structures. Use navigation planning software to perform three-dimensional reconstruction of the lungs to assist in planning the ablation delivery path;

[0131] Step S30: Real-time visual guidance: Use the image acquisition device 1 of the pulse ablation device to guide the delivery of the tube body component 3, and slowly apply external force to push the tube body component 33 along the bronchus to the position to be ablated. Match and display the real-time image acquired by the image acquisition device 1 with the virtual navigation path. At the same time, the image acquisition device 1 can also be used to identify key anatomical structures such as tumors and blood vessels in real time, and provide auxiliary diagnostic information. Fusion of the image acquisition device 1 with CT or ultrasound images can provide more anatomical information to help doctors locate tumors or lesions more accurately;

[0132] Step S40: Placing the electrode assembly 2: Under real-time visual guidance, after confirming the position to be ablated, confirm the direction in which the distal end of the tube assembly 3 needs to be bent, and control the traction assembly 402 to drive the distal end of the tube assembly 3 to bend toward the proximal end of the tube assembly 3 in at least two directions, so that the distal end of the tube assembly 3 is accurately placed at the position to be ablated; during the operation, the final placement position of the electrode assembly 2 is confirmed by CT image fusion positioning technology to ensure the best placement effect of the electrode assembly 2;

[0133] Step S50: Extending the electrode assembly 2: After the tube assembly 3 is accurately positioned at the position to be ablated, the pushing assembly 402 drives the electrode assembly 2 to extend out of the curved section 301 as a whole through the outer tube 203 in the electrode assembly 2, and is convexly disposed outside the curved section 301;

[0134] Step S60: electrode 201 is unfolded: after the electrode assembly 2 is extended to abut against the position to be ablated, the limiting assembly 407 is connected to the pushing assembly 402 to limit the movement of the pushing assembly 402. At this time, the outer tube 203 in the electrode assembly 2 is fixed to the pushing assembly 402; the pulling assembly 3 pulls the inner tube 204 in the electrode assembly 2, so that the electrode 201 is unfolded to expand the contact area between the electrode 201 and the position to be ablated;

[0135] Step S70: Pulse ablation: After the electrode assembly 2 is placed, the electric pulse is tested to observe the muscle contraction and ECG synchronization. After confirming that the electrical impedance of the tissue is within an acceptable range, ablation with optimal ablation parameters is performed. Nanosecond and / or microsecond electric pulses are applied to the location to be ablated to change the permeability of organelles and / or cell membranes to control cell death. The non-thermal nature of pulsed electric field ablation enables it to destroy cancer cells while minimizing the impact on surrounding normal tissues. Observation and CT scanning are performed immediately after the ablation operation to confirm that the real-time ablation range completely covers the tumor area, and that normal tissues do not have complications such as severe bleeding and pneumothorax, and the pulse ablation device is removed.

[0136] Embodiment 1

[0137] See attached Figure 1-7 The present embodiment provides a pulse ablation device, comprising: an electrode assembly 2; a handle assembly 4; a tube assembly 3, comprising a support segment 302 and a curved segment 301 for accommodating the electrode assembly 2, which are sequentially connected from the distal end to the proximal end, and the proximal end of the support segment 302 is connected to the handle assembly 4; a first drive assembly is arranged on the handle assembly 4, the first drive assembly is transmission-connected to the curved segment 301, and the first drive assembly can drive the curved segment 301 to bend toward the proximal end of the curved segment 301; a second drive assembly is arranged on the handle assembly 4, and is transmission-connected to the electrode assembly 2, and the second drive assembly can drive the electrode assembly 2 to move relative to the curved segment 301, and can drive the electrode assembly 2 to contract or expand.

[0138] In this embodiment, when the tube assembly 3 reaches the position to be ablated, the pushing assembly 402 controls the electrode assembly 2 to push forward a fixed distance. When the electrode assembly 2 and the tube assembly 3 need to be bent, the bending adjustment of the distal end of the tube assembly 3 is operated by the pulling assembly 404 until the relevant area is input; when the electrode assembly 2 needs to be unfolded, the pulling assembly 403 drives the inner tube 204 to move relative to the outer tube 203, so that the electrode 201 in the electrode assembly 2 is unfolded to expand the ablation area between the electrode 201 and the position to be ablated.

[0139] Specifically, the tube body assembly 3 in the pulse ablation device can be positioned at the position to be ablated. Before positioning, the distal end of the tube body assembly 3 is bent by operating the traction assembly 404 to achieve precise positioning of the tube body assembly 3 and the position to be ablated. After the electrode 201 extends out of the curved section 301, if the electrode 201 needs to adjust its relative position with the position to be ablated, the distal end of the tube body assembly 3 can be bent by operating the traction assembly 404, thereby driving the electrode 201 to bend, thereby achieving position adjustment between the electrode 201 and the position to be ablated.

[0140] After the tube body assembly 3 is positioned, the electrode assembly 2 can extend out of the curved section 301, and the electrode assembly 2 is unfolded to adapt to the area of ​​the position to be ablated, so that the electrode assembly 2 is in close contact with a large area of ​​the position to be ablated, thereby ensuring the pulse ablation effect of the electrode assembly 2 on the position to be ablated; for ease of understanding, the pulse ablation device is introduced in the following description by taking the example of delivering the electrode assembly 2 to the peripheral bronchus to treat malignant lung nodules. The electrode assembly 2 in this embodiment is configured to transmit pulse energy to the target lesion for irreversible electroporation ablation; the electrode assembly 2 is configured so that at least one electrode 201 contacts the lesion tissue; wherein, when only one electrode 201 contacts the lesion, an energy release loop is formed with the body surface electrode 201 to achieve local irreversible electroporation ablation of small lesions; when at least two adjacent electrodes 201 can contact the lesion, bipolar ablation can be achieved, that is, the pulsed electric field is transmitted through adjacent electrodes of opposite sex; optionally, the electrode assembly 2 is composed of a distal electrode 201 and a proximal electrode 201; the distal electrode 201 and the proximal electrode 201 are arranged axially at intervals along the tube body assembly 3; the exterior of the distal electrode 201 and the proximal electrode 201 are conductive surfaces; the distal electrode 201 and / or the proximal electrode 201 can be expanded from a tubular shape to an ellipsoid or a spindle shape to more fully contact the lesion tissue and improve the pulse energy delivery effect.

[0141] In this embodiment, the pulse ablation device is mainly used for tumor ablation treatment, especially for tumors that are difficult to observe or irregular. The electrode assembly 2 arranged at the distal end of the tube body assembly 3 can be extended into the diseased tissue, and the outer surface of the electrode assembly 2 is abutted against the diseased tissue. The pushing assembly 402 and the pulling assembly 403 drive the movement of the electrode assembly 2 and adjust the diameter of the electrode assembly 2 to improve the electrode pulse energy transmission efficiency and prevent the electrode assembly 2 from shifting during the ablation process. At the same time, the electrode assembly 2 can also adapt to lesions of different shapes or sizes, so that the electrode assembly 2 in this embodiment, driven by the pushing assembly 402 and the pulling assembly 403, can perform pulse ablation on tumors that are difficult to observe or irregular, while ensuring the ablation effect.

[0142] Preferably, the pulse formed by the electrode assembly 2 can emit pulses with a width of microns or nanoseconds to the pulmonary diseased tissue, so as to damage the stability of the surface of the diseased tissue cell membrane and cause multiple hydrophilic micropores to appear on the surface of the diseased tissue cells, thereby destroying the homeostasis of the diseased tissue cells and causing the diseased tissue cells to die, thereby achieving the therapeutic effect of pulse ablation of the diseased tissue.

[0143] In this embodiment, the electrode assembly 2 includes an electrode 201, which is a tubular structure with a cavity inside; driven by the second driving assembly, the opposite ends of the electrode 201 move toward each other until the tubular structure expands, or the opposite ends of the electrode 201 move away from each other until the tubular structure contracts.

[0144] In this embodiment, the electrode 201 in the electrode assembly 2 can be contracted or expanded, that is, the outer diameter of the electrode assembly 2 can be extended and deformed to adapt to lesions of different sizes; the conductor part in the electrode 201 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.

[0145] In this embodiment, when the electrode 201 is in a contracted state, the cross section of the electrode 201 is cylindrical; when the electrode 201 is in an expanded state, the cross section of the electrode 201 is elliptical.

[0146] Specifically, in order to achieve the expected expanded shape of the electrode assembly 2, the electrode assembly 2 is initially a cylindrical structure and / or a tubular structure, etc.; the head end of the electrode 201 is preferably arc-shaped or conical, so as to facilitate penetrating into the narrower sections of the bronchus and the inside of the lesion; in order to better fit the peripheral bronchial lesions, increase the effective contact area of ​​the electrode, and achieve a larger radial ablation range, the electrode assembly 2 is an expandable structure, such as a woven mesh structure, a sac structure, a spline structure, etc.; the initial diameter of the electrode 201 is preferably φ1.0mm to φ2.8mm, and the diameter after expansion is preferably φ2.0mm to φ20mm.

[0147] In this embodiment, the electrode 201 is a tubular structure woven from metal wires; and / or, the electrode 201 is a tubular structure formed by at least two simply supported beams circumferentially spaced around the distal end of the tube body assembly 3; wherein, along the length direction of the simply supported beams, the surface slope of the simply supported beams gradually changes from small to large, and then gradually changes from large to small, so as to form an arch structure; the electrode 201 is woven from metal wires in a weaving manner of one-on-one, one-on-two, or two-on-two.

[0148] In this embodiment, the electrode assembly 2 also includes an inner tube 204 and an outer tube 203 sleeved on the inner tube 204, and the tube body assembly 3 is sleeved on the outer tube 203; the distal end of the electrode 201 is fixedly connected to the distal end of the inner tube 204, and the proximal end of the electrode 201 is fixedly connected to the outer tube 203; driven by the second driving assembly, the inner tube 204 can move relative to the outer tube 203 to adjust the distance between the opposite ends of the electrode 201.

[0149] In this embodiment, when the outer tube 203 is fixed relative to the tube body assembly 3 , the inner tube 204 can drive the distal end of the electrode 201 to move toward the proximal end of the electrode 201 , thereby realizing the deployment of the electrode 201 .

[0150] In this embodiment, the outer tube 203 is sleeved on the inner tube 204, and there is a gap between the outer tube 203 and the inner tube 204 to facilitate air circulation.

[0151] In this embodiment, when the electrode 201 is retracted into the curved section 301 , the distal end of the electrode assembly 2 is spaced 5 mm from the distal end of the tube assembly 3 .

[0152] In this embodiment, the electrode assembly 2 also includes a first fixing member and a second fixing member 202, the first fixing member is arranged at the distal end of the electrode assembly 2, and the second fixing member 202 is arranged at the proximal end of the electrode assembly 2; the first fixing member and the second fixing member 202 are respectively arranged at both ends of the electrode 201, and the electrode 201 is fixedly connected to the outer tube 203 through the second fixing member 202.

[0153] In this embodiment, the materials of the first fixing member and the second fixing member 202 are developing materials.

[0154] In this embodiment, the distal end of the first fixing member disposed at the distal end of the electrode 201 is in an arc shape or a cone shape, which can facilitate the electrode 201 to enter the position to be ablated.

[0155] In this embodiment, the tube body assembly 3 has a distal end and a proximal end that are relatively set, the distal end of the curved section 301 is at the same position as the distal end of the tube body assembly 3, the distal end of the support section 302 is fixedly connected to the proximal end of the curved section 301, and the proximal end of the support section 302 is at the same position as the proximal end of the tube body assembly; the electrode 201 has a distal end and a proximal end that are relatively set, and when the electrode 201 is retracted in the curved section 301, the distal end of the electrode 201 is close to the distal end of the curved section 301, and the proximal end of the electrode 201 is far away from the distal end of the curved section 301.

[0156] In this embodiment, the tube body component 3 is configured to deliver the image acquisition device 1 and the electrode component 2 to the target lesion area. The hardness of the tube body component 3 gradually decreases from the proximal end of the tube body component 3 to the distal end of the tube body component 3. The material of the tube body component 3 is at least one of polyetheramide, nylon, thermoplastic polyurethane, polytetrafluoroethylene, silicone or fluororubber, etc., so that the distal end of the tube body component 3 can be delivered in a curved or forked lumen. The supporting capacity of the proximal end of the tube body component 3 ensures that the tube body component 3 is smoothly delivered to the target lesion area.

[0157] In this embodiment, when the hardness of the tube body assembly 3 gradually changes, the hardness of the inner tube 204 in the electrode assembly 2 gradually decreases from the proximal end of the tube body assembly 3 to the distal end of the tube body assembly 3, and / or the hardness of the outer tube 203 in the electrode assembly 2 gradually decreases from the proximal end of the tube body assembly 3 to the distal end of the tube body assembly 3.

[0158] In this embodiment, an image acquisition device 1 is provided at the distal end of the curved section 301 ; the electrode assembly 2 is arranged within the field of view of the image acquisition device 1 , and the image acquisition device 1 is used to acquire image information of the position to be ablated and image information of the electrode assembly 2 .

[0159] In this embodiment, the image acquisition device 1 is used to obtain image information of surrounding tissues, and the above-mentioned image information is at least one of picture information or video information. By setting up the image acquisition device 1, it is convenient for users to directly observe the lesion area, reduce reliance on indirect guidance of traditional imaging equipment (such as CT or ultrasound), and thus improve the safety and accuracy of pulse treatment; the image acquisition device 1 is arranged at the end of the tube body assembly 3 or near the end. Preferably, the image acquisition device 1 is arranged on the end face of the distal end of the curved section 301.

[0160] In this embodiment, the image acquisition device 1 is a device capable of acquiring images, such as a camera or a miniature camera; at least one image acquisition device 1 is disposed at the distal end of the curved section 301, and the image acquisition device 1 can be disposed on the end surface of the curved section 301 or on the side wall of the curved section 301, as long as the image acquisition device 1 can acquire image information of the distal end of the curved section 301 in real time.

[0161] In this embodiment, at least one light source assembly 5 is further included; the illumination range of the at least one light source assembly 5 at least partially covers the field of view of the image acquisition device 1 .

[0162] In this embodiment, the light source assembly 5 is distributed around the image acquisition device 1 to provide lighting in a low-light environment to ensure a clear field of vision. The light source assembly 5 is preferably a light-guiding optical fiber or an LED light source; the instrument channel 303 and the electrode assembly 2 are coaxial structures with a gap therebetween.

[0163] In this embodiment, the pulse ablation device further includes a controller, and the image acquisition device 1 and the light source assembly 5 are in communication connection with the controller, and the controller can control the opening and closing of the image acquisition device 1 and the light source assembly 5 .

[0164] In this embodiment, the handle assembly 4 is provided with a accommodating area, which is used to accommodate the pushing assembly 402 and the pulling assembly 403; either the accommodating area or the pushing assembly 402 is provided with a slide rail, and the other is provided with a slider matching the slide rail, and the pushing assembly 402 is slidably connected to the handle assembly 4.

[0165] In this embodiment, the handle assembly 4 also includes a handle shell, a receiving area is arranged on the handle shell, a pushing assembly 402 and a pulling assembly 403 are arranged behind the receiving area, and partially protrude from the handle shell; a gripping portion 405 is arranged on the side of the handle shell away from the electrode assembly 2.

[0166] In this embodiment, the pushing component 402 is a shell with an opening on one side, the pushing component 402 is provided with a first mounting hole, the pulling component 403 is provided with a second mounting hole, and the first mounting hole and the second mounting hole are coaxially arranged; the proximal end of the outer tube 203 in the electrode assembly 2 is installed in the first mounting hole, and the proximal end of the inner tube 204 in the electrode assembly 2 passes through the first mounting hole and the second mounting hole in sequence.

[0167] In this embodiment, a slider is provided on the outer wall of the pushing component 402, and a corresponding slide rail is provided in the accommodating area. The pushing component 402 moves relative to the handle shell, and the arrangement direction of the slide rail is consistent with the direction from the distal end to the proximal end of the tube body component 3. Preferably, sliders are provided on both sides of the opposite sides of the pushing component 402, which can improve the stability of the sliding connection between the pushing component 402 and the handle component 4.

[0168] In this embodiment, the length of the slide rail is not limited, as long as the pushing component 402 can slide with the slide rail when driving the electrode component 2 to move between its first extreme position and the second extreme position.

[0169] In this embodiment, the second mounting hole passes through the pulling member 4032, and the pulling member 4032 includes a connecting portion and an abutting portion connected in sequence. When the pulling member 4032 drives the inner tube 204 to move relative to the outer tube 203, the connecting portion can slide inside the pushing component 402; when the pulling component 403 is in the initial position, that is, when the inner tube 204 is not pulled, the connecting portion is completely arranged in the pushing component 402, and the abutting portion abuts against the side wall of the pushing component 402. When the pulling component 403 pulls the inner tube 204 until the diameter of the electrode 204 moves to the maximum, the pulling member 4032 drives the inner tube 204 to move toward the side away from the limiting component 407, and part of the connecting portion is arranged in the pushing component 402, and there is a gap between the limiting portion and the side wall of the pushing component 402.

[0170] In this embodiment, the connecting portion and the pushing assembly 402 are interference fit.

[0171] In this embodiment, the connection portion is fixedly connected to the inner tube 204 via a pull wire 4031 , and the pull wire 4031 is disposed in the pushing assembly 402 .

[0172] In this embodiment, the first driving component includes a traction structure 406 and a traction component 404 fixedly arranged on the handle component 4; at least two force application positions are evenly spaced around the circumference of the bending section 301, the first end of the traction structure 406 is respectively connected to the at least two force application positions, and the second end of the traction structure 406 is connected to the traction component 404; the traction component 404 can apply traction force to each force application position respectively to drive the bending section 301 to bend toward the support section 302 in at least two directions corresponding to the at least two force application positions.

[0173] In this embodiment, the traction component 404 is arranged in the middle area of ​​the handle shell and can rotate around the rotating axis; the traction component 404 is fixed to the traction structure 406 inside, and the displacement movement of the traction structures 406 on both sides is controlled by rotation, thereby driving the bending adjustment of the distal bending part of the tube body component 3; at least two traction ends are arranged on one side of the traction structure 406 close to the force application position, and the traction ends are arranged corresponding to the force application position.

[0174] In this embodiment, the traction structure 406 is a traction rope, and the traction component 404 is a rotating wheel. A rotating shaft is provided on the rotating wheel, and the rotating wheel is rotatably connected to the rotating shaft. The rotating shaft is fixedly provided on the handle housing, and the traction rope is wound around the rotating wheel; the traction rope is wound around the rotating wheel, and the traction rope is fixedly connected to the force application positions respectively.

[0175] Specifically, there is one traction rope wound around the same rotating wheel.

[0176] In this embodiment, the setting position and setting direction of the rotating wheel are not set, as long as the traction rope wound thereon is approximately parallel to the axis of the curved section 301.

[0177] In this embodiment, four force application positions are evenly spaced around the circumference of the bending section 301, and two sets of traction components 404 are required to drive the bending section 301 to bend toward the supporting section 302 in four directions corresponding to the four force application positions.

[0178] In this embodiment, both traction assemblies 404 are rotating wheels, and the structures of the two traction assemblies 404 are the same, and the only difference is the location of the two wheels. The two wheels do not interfere with each other during rotation, and the axes of the rotating shafts arranged on the two wheels are arranged vertically.

[0179] In this embodiment, each traction assembly 404 can rotate clockwise or counterclockwise. When the traction assembly 404 rotates clockwise, the traction structure 406 applies a pulling force to a force application position and bends toward the support segment 302 in a direction corresponding to the force application position.

[0180] In this embodiment, four force-applying positions are evenly spaced around the circumference of the curved section 301, and the angle between each force-applying position is 90 degrees. The four exemplary force-applying positions are respectively at 3 o'clock, 6 o'clock, 9 o'clock and 12 o'clock. The traction structure 406 has four traction ends, and the four traction ends are respectively fixedly connected to the force-applying positions arranged at 3 o'clock, 6 o'clock, 9 o'clock and 12 o'clock to achieve multi-angle adjustment of the curved section 301.

[0181] Exemplarily, pulling the traction end attached at the 12 o'clock position causes the curved section 301 to deflect upward, and pulling the traction end attached at the 6 o'clock position causes the curved section 301 to deflect downward; pulling the traction end attached at the 3 o'clock position causes the right front end of the curved section 301 to deflect; pulling the traction end attached at the 9 o'clock position causes the left front end of the curved section 301 to deflect.

[0182] In this embodiment, the bending section 301 is provided with a deformable hollow structure, and the hollow structure can provide a deformation amount for the bending section 301 to bend toward the supporting section 302 .

[0183] In this embodiment, the hollow structure includes at least one of a thread-shaped groove structure, a grid groove structure, a grid hollow structure or a corrugated groove structure; the hollow structure includes a grid hollow structure, and adjacent grid units in the grid hollow structure are rotationally connected.

[0184] In this embodiment, the grid hollow structure is connected by a series of pivot pins, and adjacent grid units are connected by pivot pins, each pivot pin is offset 90 degrees from the adjacent pivot; the grid unit is a quadrilateral structure, and the four vertices of the four-deformation structure are provided with pivot pins; each pivot pin is offset 90 degrees from the adjacent pivot, and the two pivot pins of the first group of grid units that are relatively arranged allow the grid unit to curl in the up and down directions. The two pivot pins of the second group that are relatively arranged allow the grid unit to curl in the left and right directions. In this way, the grid hollow structure with multiple grid units, that is, the bending section 301, can be curled in any direction under the action of the above-mentioned grid units and pivot pins. The bending of the far end of the bending section 301 toward the support section 302 is achieved by pulling the traction structure 406 at different positions.

[0185] In this embodiment, the second driving component includes a pushing component 402 and a pulling component 403; the first end of the pushing component 402 is fixedly connected to the outer tube 203 of the electrode assembly 2, and the pushing component 402 can drive the electrode assembly 2 to reciprocate relative to the bending section 301; the second end of the pushing component 402 can be slidably connected to the pulling component 403, and the pulling component 403 is fixedly connected to the inner tube 204 of the electrode assembly 2; the pulling component 403 can drive the inner tube 204 to move relative to the outer tube 203 to adjust the distance between the opposite ends of the electrode 201.

[0186] In this embodiment, the push rod assembly 402 and the pull rod assembly 403 are located in the middle part of the handle housing, and are used for pushing the electrode assembly 3 as a whole and opening and closing the electrode parts.

[0187] In this embodiment, the second driving component also includes a limit component 407, which can switch between a limit state and a free state; when the limit component 407 is in the limit state, the limit component 407 can limit the movement of the pushing component 402; when the limit component 407 is in the free state, the pushing component 402 can move relative to the limit component 407.

[0188] In this embodiment, the limiting component 407 is protruded from the handle component 4, and the user can directly apply external force to the limiting component 407 to drive the limiting component 407 to move.

[0189] In this embodiment, the specific structure of the limiting component 407 is not limited, as long as the limiting component 407 can limit the pushing component 402.

[0190] In this embodiment, the limiting component 407 is a nut, the inner wall and the outer wall of the nut are both threaded, the nut is sleeved on the connecting shaft and is threadedly connected to the connecting shaft, the connecting shaft is fixedly connected to the handle shell, and one end of the above-mentioned connecting shaft is connected to the pushing component 402. When the pushing component 402 is not limited by the limiting component 407, the pushing component 402 can move relative to the connecting shaft, and the limiting component 407 can rotate relative to the connecting shaft; the pushing component 402 is provided with a connecting boss, the connecting boss is coaxially arranged with the connecting shaft, and the inner wall of the connecting boss is provided with an internal thread that matches the external thread of the nut; when the pushing component 402 is limited by the limiting component 407, the nut is sleeved on the connecting shaft, and the external thread of the nut is threadedly connected to the internal thread of the connecting protrusion, so as to realize the relative fixation of the pushing component 402, the limiting component 407 and the connecting shaft.

[0191] In this embodiment, the pulling component 403 includes a pulling wire 4031 and a pulling member 4032, and the two ends of the pulling wire 4031 are fixedly connected to the inner tube 204 and the pulling member 4032 respectively; the pulling member 4032 is transmission-connected to the pushing component 402, and when the pushing component 402 is restricted from moving, the pulling member 4032 can slide relative to the pushing component 402, and the pulling member 4032 can drive the inner tube 204 to move relative to the outer tube 203 through the pulling wire 4031 to adjust the distance between the two opposite ends of the electrode 201.

[0192] In this embodiment, it also includes a rotating member 401 and a rotating shaft; the rotating member 401 is sleeved on the rotating shaft, and one end of the rotating shaft can be fixedly connected to the handle assembly 4; the rotating member 401 is fixedly connected to the proximal end of the support segment 302, and the proximal end of the support segment 302 is rotatably connected to the handle assembly 4 through the rotating member 401.

[0193] In this embodiment, the rotating member 401 is a rotating ring, which is fixedly connected to the proximal end of the support section 302 , and is rotatably connected to the handle shell of the handle assembly 4 , and the rotating shaft is fixedly arranged at the distal end of the gripping portion 405 .

[0194] 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.

[0195] In the absence of conflict, the above embodiments and features in the embodiments can be combined with each other.

[0196] 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 pulse ablation device, characterized in that: include: Electrode assembly (2); Handle assembly (4); A tube body assembly (3), comprising a support segment (302) connected in sequence from the distal end to the proximal end and a curved segment (301) for accommodating the electrode assembly (2), wherein the proximal end of the support segment (302) is connected to the handle assembly (4); a first driving assembly disposed on the handle assembly (4), the first driving assembly being in driving connection with the bending section (301), and the first driving assembly being capable of driving the bending section (301) to bend toward the proximal end of the bending section (301); A second driving assembly arranged on the handle assembly (4) is transmission-connected to the electrode assembly (2); the second driving assembly can drive the electrode assembly (2) to move relative to the bending section (301), and can drive the electrode assembly (2) to contract or expand.

2. The pulse ablation device according to claim 1, characterized in that: An image acquisition device (1) is provided at the distal end of the curved section (301); The electrode assembly (2) is arranged within the field of view of the image acquisition device (1), and the image acquisition device (1) is used to acquire image information of the position to be ablated and image information of the electrode assembly (2).

3. The pulse ablation device according to claim 2, characterized in that: Also includes at least one light source assembly (5); The illumination range of the at least one light source assembly (5) at least partially covers the field of view of the image acquisition device (1).

4. The pulse ablation device according to claim 1, characterized in that: The electrode assembly (2) comprises an electrode (201), wherein the electrode (201) is a tubular structure having a cavity inside; Driven by the second driving component, the two opposite ends of the electrode (201) move toward each other until the tubular structure is expanded, or the two opposite ends of the electrode (201) move away from each other until the tubular structure is contracted.

5. The pulse ablation device according to claim 4, characterized in that: The electrode assembly (2) further comprises an inner tube (204) and an outer tube (203) sleeved on the inner tube (204), and the tube body assembly (3) is sleeved on the outer tube (203); The distal end of the electrode (201) is fixedly connected to the distal end of the inner tube (204), and the proximal end of the electrode (201) is fixedly connected to the outer tube (203); Driven by the second driving assembly, the inner tube (204) can move relative to the outer tube (203) to adjust the distance between the two opposite ends of the electrode (201).

6. The pulse ablation device according to claim 4, characterized in that: When the electrode (201) is retracted into the curved section (301), the distance between the distal end of the electrode (201) and the distal end of the tube assembly (3) is 4-8 mm.

7. The pulse ablation device according to claim 5, characterized in that: The electrode assembly (2) further comprises a first fixing member and a second fixing member (202), wherein the first fixing member is arranged at the distal end of the electrode assembly (2), and the second fixing member (202) is arranged at the proximal end of the electrode assembly (2); The first fixing member and the second fixing member (202) are respectively arranged at two ends of the electrode (201), and the electrode (201) is fixedly connected to the outer tube (203) via the second fixing member (202).

8. The pulse ablation device according to claim 1, characterized in that: The second driving component includes a pushing component (402) and a pulling component (403); The first end of the pushing component (402) is fixedly connected to the outer tube (203) of the electrode component (2), and the pushing component (402) can drive the electrode component (2) to move back and forth relative to the curved section (301); The second end of the pushing component (402) can be slidably connected to the pulling component (403), and the pulling component (403) is fixedly connected to the inner tube (204) of the electrode component (2); the pulling component (403) can drive the inner tube (204) to move relative to the outer tube (203) to adjust the distance between the two opposite ends of the electrode (201).

9. The pulse ablation device according to claim 8, characterized in that: The second driving component further comprises a limiting component (407), and the limiting component (407) is capable of switching between a limiting state and a free state; When the limiting component (407) is in the limiting state, the limiting component (407) is capable of limiting the movement of the pushing component (402); When the limiting component (407) is in the free state, the pushing component (402) can move relative to the limiting component (407).

10. The pulse ablation device according to claim 8, characterized in that: The handle assembly (4) is provided with a receiving area, and the receiving area is used to receive the pushing assembly (402) and the pulling assembly (403); Either the accommodating area or the pushing assembly (402) is provided with a slide rail, and the other is provided with a slider matched with the slide rail, and the pushing assembly (402) is slidably connected to the handle assembly (4).

11. The pulse ablation device according to claim 8, characterized in that: The pulling assembly (403) comprises a pulling wire (4031) and a pulling member (4032), and two ends of the pulling wire (4031) are fixedly connected to the inner tube (204) and the pulling member (4032) respectively; The pulling member (4032) is in transmission connection with the pushing assembly (402). When the pushing assembly (402) is restricted from moving, the pulling member (4032) can slide relative to the pushing assembly (402). The pulling member (4032) can drive the inner tube (204) to move relative to the outer tube (203) through the pull wire (4031) to adjust the distance between the two opposite ends of the electrode (201).

12. The pulse ablation device according to claim 1, characterized in that: Also includes a rotating member (401) and a rotating shaft; The rotating member (401) is sleeved on the rotating shaft, and one end of the rotating shaft can be fixedly connected to the handle assembly (4); The rotating member (401) is fixedly connected to the proximal end of the supporting section (302), and the proximal end of the supporting section (302) is rotatably connected to the handle assembly (4) via the rotating member (401).

13. The pulse ablation device according to any one of claims 1 to 12, characterized in that: The first driving assembly comprises a traction structure (406) and a traction assembly (404) fixedly arranged on the handle assembly (4); At least two force-applying positions are evenly spaced around the circumference of the curved section (301), the first end of the traction structure (406) is respectively connected to the at least two force-applying positions, and the second end of the traction structure (406) is connected to the traction assembly (404); The traction assembly (404) is capable of applying traction force to each of the force application positions respectively, so as to drive the bending section (301) to bend toward the supporting section (302) in at least two directions corresponding to the at least two force application positions.

14. The pulse ablation device according to claim 13, characterized in that: At least four force-applying positions are evenly spaced around the circumference of the bending section (301); the traction assembly (404) is capable of applying traction to each of the force-applying positions, respectively, so as to drive the bending section (301) to bend toward the supporting section (302) in at least four directions corresponding to the at least four force-applying positions.

15. The pulse ablation device according to any one of claims 1 to 12, characterized in that: The bending section (301) is provided with a deformable hollow structure, and the hollow structure can provide a deformation amount for the bending section (301) to bend toward the supporting section (302).

16. The pulse ablation device according to claim 15, characterized in that: The hollow structure includes at least one of a thread-shaped groove structure, a grid-shaped groove structure, a grid hollow structure or a corrugated groove structure.

17. The pulse ablation device according to claim 16, characterized in that: The hollow structure includes a grid hollow structure, and adjacent grid units in the grid hollow structure are rotationally connected.

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