Pulsed electric field ablation device

Abstract

The present invention belongs to the field of medical device technology, and specifically relates to a pulsed electric field ablation device. A pulsed electric field ablation device includes an electrode structure, a connecting rod, and a handle connected in sequence from the distal end to the proximal end; the electrode structure is rotatably connected to the connecting rod via a connecting shaft, and the axial direction of the connecting shaft is perpendicular to the axial direction of the connecting rod; the pulsed electric field ablation device also includes a rotary drive structure, and the rotary drive structure includes: a pushing component, which is arranged on the handle; a transmission component, the proximal end of which is connected to the pushing component, and the distal end of which is connected to the electrode structure, and the electrode structure is driven to rotate by the pushing component via the transmission component. The present invention can flexibly control the direction and position of the electrode structure by driving the electrode structure to rotate via the transmission component through the pushing component, so as to achieve the purpose of switching the ablation direction or position.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a pulsed electric field ablation device. Background Art

[0002] Atrial fibrillation is a cardiac arrhythmia accompanied by uncoordinated atrial electrical activity, which leads to ineffective atrial contraction. Clinically, it can cause various serious diseases such as arrhythmia, stroke, heart failure, and even fatal myocardial embolism.

[0003] The pulmonary veins are a major cause of atrial fibrillation due to the presence of pulmonary vein myocardial sleeves. Between the intima and adventitia of the pulmonary veins lie colonies of cardiomyocytes. Because the cells forming these myocardial sleeves are derived from different sources than the atrial myocardium and have different electrophysiological properties, they form an abnormally excited matrix, leading to atrial fibrillation.

[0004] Late-stage atrial fibrillation can lead to heart failure, an incurable disease that constantly threatens patients' lives. Heart failure can be caused by a variety of factors. Unilateral catheter ablation of the major splanchnic nerves restores the sympathetic nervous system to normal, allowing the viscera to contract normally. This redistributes blood flow throughout the body, normalizes cardiopulmonary pressure, and ultimately reduces heart failure symptoms. This represents a novel approach to treating heart failure. During the neurotherapy process, the inner wall of the blood vessels is protected, allowing more effective information to be delivered to the nerves on the outer wall.

[0005] Catheter radiofrequency ablation has gained more clinical applications due to its simple structure and easy operation. However, as a type of thermal ablation, radiofrequency ablation can cause damage to surrounding tissues during the ablation process, and there may be problems with incomplete ablation due to the deep location of some lesions.

[0006] Different tissues have different breakdown voltages. Pulsed electric field ablation is designed based on this feature. It applies voltage around the tissue to form an electric field of a specific intensity, which breaks down the tissue that causes abnormal electrical signals while having almost no effect on other tissues. In addition, the operation time is short and the patient does not need ICU observation after the operation.

[0007] Currently, the main methods for treating atrial fibrillation through pulsed electric field ablation include: femoral vein catheter ablation, surgical clamps, etc. These two methods either require a long surgical approach and high equipment requirements, or require open-chest surgery, which causes great damage to the patient. Therefore, it is necessary to develop a method that can reduce patient pain without significantly prolonging the operation time.

[0008] U.S. Patent US2018 / 03225577A1 discloses a radiofrequency ablation device with a sensor, which uses a pulsed current to stimulate the pulmonary vein orifice through a bipolar probe to achieve the purpose of eliminating atrial fibrillation. On the one hand, it is radiofrequency ablation, which damages tissue through heat to achieve the purpose of electrical signal conduction block. On the other hand, the electrode head where the probe is located is fixedly connected to the connecting rod. During the operation, it is necessary to control the direction of the distal electrode head by rotating the handle or adjusting the angle of the handle. On the one hand, this method is not conducive to operation. On the other hand, in practice, due to the existence of tissue resistance, the rotation angle of the handle will have an angle difference with the rotation angle of the electrode head. The adjustment accuracy of the electrode head is not easy to control. During the rotation process, the connecting rod and the electrode head are prone to bouncing. Summary of the Invention

[0009] The present invention aims to provide a pulsed electric field ablation device in order to solve the technical problem in the prior art that the direction and position of an electrode plate are difficult to control.

[0010] A pulsed electric field ablation device comprises an electrode structure, a connecting rod and a handle connected in sequence from a distal end to a proximal end;

[0011] The electrode structure is rotatably connected to the connecting rod via a connecting shaft, and the axial direction of the connecting shaft is perpendicular to the axial direction of the connecting rod;

[0012] The pulsed electric field ablation device further includes a rotation drive structure, which includes:

[0013] a pushing assembly, disposed on the handle;

[0014] A transmission component has a proximal end connected to the pushing component and a distal end connected to the electrode structure, and the pushing component drives the electrode structure to rotate via the transmission component.

[0015] As a preferred solution, the pushing component includes:

[0016] A push button with an arc-shaped structure located outside the handle;

[0017] A rotating ring is provided in the handle and is connected to the push button via a push rod;

[0018] a fixed rotating shaft, both ends of which pass through the rotating ring and are fixed to the inner wall of the handle, the fixed rotating shaft being rotatably connected to the rotating ring, and the axial direction of the fixed rotating shaft being parallel to the axial direction of the connecting rotating shaft;

[0019] The transmission assembly comprises:

[0020] a transmission fixed wheel, the distal end of which is fixedly connected to the electrode structure, and the two sides of which are rotatably connected to the connecting rod via the connecting shaft;

[0021] The two pulling wires have proximal ends arranged on the rotating ring opposite to each other, and distal ends passing through the connecting rod and fixedly connected to the transmission fixed wheels respectively.

[0022] As a preferred solution, a raised block, a raised point or a raised strip is provided on the outer peripheral surface of the push button.

[0023] As a preferred solution, the push button is provided with extension sections on both sides along its rotation direction, the thickness of the extension sections is smaller than the thickness of the push button, and the extension sections are located outside the handle and move against the outer periphery of the handle.

[0024] As a preferred solution, the rotating ring is provided with extension cylinders on both axial sides of the fixed shaft, the inner diameter of the extension cylinders is the same as the inner diameter of the rotating ring, and the inner wall of the extension cylinders is flush with the inner wall of the rotating ring.

[0025] As a preferred solution, the rotating ring is provided with two connecting through holes, and the length direction of the connecting through holes is parallel to the axial direction of the connecting rod;

[0026] The proximal end of one of the pull wires passes through a corresponding one of the connecting through holes and is fixedly connected to the connecting through hole.

[0027] As a preferred embodiment, the distal side of the transmission fixed wheel is a plane or an arc-shaped surface recessed toward the proximal end, and the proximal side of the transmission fixed wheel is an arc surface, with wire accommodating grooves dug on both sides of the outer circumference of the arc surface from the proximal end to the distal end, and the wire accommodating grooves are connected to the distal side of the transmission fixed wheel;

[0028] The distal ends of the two pulling wires are respectively extended from the proximal end of the transmission fixed wheel along the two pulling wire accommodating grooves to the distal end side of the transmission fixed wheel and are combined into one strand and fixed in the electrode structure.

[0029] As a preferred solution, the handle includes:

[0030] a handle guide section connected to the proximal end of the connecting rod;

[0031] A handle pushing section is provided with the pushing assembly, at least one section of the outer wall of which is an arc section, and the push button is provided on the outer side of the arc section;

[0032] A handle grip section has a proximal end provided with a high-voltage generator connector, and the high-voltage generator connector is connected to the electrodes in the electrode structure via a wire.

[0033] As a preferred solution, the interior of the handle guide section is provided with:

[0034] a limiting groove abutting the proximal end of the connecting rod;

[0035] A pressing piece is located outside the limiting groove and presses the proximal end of the connecting rod. The pressing piece is detachably connected to the inner wall of the handle guide section.

[0036] As a preferred solution, the interior of the handle guide section is provided with:

[0037] Two guide wheels are arranged opposite to each other at a preset distance, and a gap between the two guide wheels is located on the proximal side of the connecting rod;

[0038] The proximal ends of the two pulling wires extend from the proximal end of the connecting rod and pass through between the two guide wheels and are fixedly connected to the rotating ring respectively.

[0039] As a preferred solution, the angle between the axis of the handle grip section and the axis of the connecting rod is α, 120°≤α150°;

[0040] The center of the rotating ring coincides with the vertex of the angle α.

[0041] As a preferred solution, the diameter of the high voltage generator connector is greater than 6 mm, preferably 8 mm.

[0042] As a preferred solution, the high voltage generator connector is preferably made of copper.

[0043] As a preferred solution, the connecting rod is axially provided with:

[0044] A plurality of hollow grooves are connected to the inside and outside of the connecting rod, and two adjacent hollow grooves are opposite to each other along two sides of the circumference. The plurality of hollow grooves are at least arranged at the far end of the connecting rod.

[0045] As a preferred embodiment, the pulsed electric field ablation device further includes:

[0046] A card joint, the proximal end of which is fixedly connected to the connecting rod, and the distal end of which is rotationally connected to the transmission fixed wheel via the connecting shaft.

[0047] As a preferred solution, the card connector is a card connector with a U-shaped or Y-shaped cross section, the opening of the card connector faces the distal end, and the connecting shaft is arranged at the opening of the card connector.

[0048] As a preferred solution, the electrode structure includes:

[0049] an electrode plate, rotatably connected to the connecting rod via the connecting shaft;

[0050] at least one pair of ablation electrodes, the pair of ablation electrodes being arranged opposite to each other on the electrode plate at a preset distance;

[0051] A plurality of mapping electrodes are arranged in a row on the electrode plate.

[0052] As a preferred solution, the mapping electrode is arranged between a pair of ablation electrodes.

[0053] As a preferred solution, the arrangement direction of the mapping electrodes is consistent with the length direction of the ablation electrodes.

[0054] As a preferred solution, the electrode plate is an internally hollow electrode plate formed by snapping together two halves of an electrode plate shell.

[0055] The positive progress of the present invention is that the pulsed electric field ablation device of the present invention has the following advantages:

[0056] 1. By pushing the assembly to drive the electrode structure to rotate via the transmission assembly, the direction and position of the electrode structure can be flexibly controlled to achieve the purpose of switching the ablation direction or position.

[0057] 2. The push button drives the pull wire to drive the electrode structure to rotate. The overall structure is simple, the volume is small, and it is easy to use.

[0058] 3. The design of the pushing component ensures high stability in cooperation with the handle.

[0059] 4. The guide wheel can not only play a guiding role, but also reduce the friction between the pull wire and the guide wheel.

[0060] 5. The detachable connection between the connecting rod and the handle can effectively limit the circumferential and axial movement of the connecting rod.

[0061] 6. The structure of the transmission fixed wheel can better fix the far ends of the two pull wires, making the connection between the two pull wires more stable.

[0062] 7. The distal end of the connecting rod is provided with a hollow groove, which can swing horizontally by about 45 degrees, realizing multi-directional rotation of the pulsed electric field ablation device, and can quickly switch the ablation position, effectively shortening the operation time to more than 40%.

[0063] 8. The target tissue is ablated through the ablation electrode, and the mapping electrode is used to determine the three-dimensional structure of the heart before ablation. That is, during the operation, there is no need to use external mapping equipment, avoiding tissue damage to the patient due to switching between different devices. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1 (a) is a schematic diagram of an overall structure of the present invention;

[0065] FIG1( b ) is a schematic diagram of FIG1( a ) from another angle;

[0066] Figure 2(a) is a front view of Figure 1(a);

[0067] Figure 2(b) is a cross-sectional view of Figure 2(a);

[0068] Figure 2(c) is a partial enlarged view of Figure 2(b);

[0069] FIG3( a ) is a partial diagram of the connection relationship between the connecting rod and the handle of the present invention;

[0070] Figure 3(b) is a schematic diagram of a portion of the structure in Figure 3(a);

[0071] FIG4( a ) is a schematic structural diagram of a pushing assembly of the present invention;

[0072] FIG4( b ) is a schematic diagram of FIG4( a ) from another angle;

[0073] FIG5(a) is a diagram showing a connection relationship between the electrode structure, the clamping joint and the connecting rod of the present invention;

[0074] FIG5(b) is a schematic diagram of a portion of the structure in FIG5(a). DETAILED DESCRIPTION

[0075] In order to make the technical means, creative features, objectives and effects achieved by the present invention easier to understand, the present invention is further described below with reference to specific illustrations.

[0076] In the present invention, when describing the pulsed electric field ablation device, "proximal end" refers to the side located in the direction of the end manipulated by the user, and correspondingly, "distal end" refers to the side away from the end manipulated by the user.

[0077] In the present invention, when describing the pulsed electric field ablation device, the “axial direction of the connecting rod 200 ” refers to the direction between the “proximal end” and the “distal end”.

[0078] Reference Figure 1(a) to Figure 5(b) A pulsed electric field ablation device includes an electrode structure 100, a connecting rod 200, and a handle 300 connected in sequence from distal to proximal. The electrode structure 100 is rotatably connected to the connecting rod 200 via a connecting shaft 110, and the axial direction of the connecting shaft 110 is perpendicular to the axial direction of the connecting rod 200.

[0079] The pulsed electric field ablation device of the present invention also includes a rotational drive structure 400, which includes a propulsion assembly 410 and a transmission assembly 420. The propulsion assembly 410 is mounted on the handle 300. The proximal end of the transmission assembly 420 is connected to the propulsion assembly 410, while the distal end of the transmission assembly 420 is connected to the electrode structure 100. The propulsion assembly 410 drives the electrode structure 100 in rotation via the transmission assembly 420. As shown in FIG1(a), the electrode structure 100 can swing up and down 90 degrees each, achieving a large rotation angle and can be controlled step by step by the propulsion assembly 410.

[0080] The present invention drives the electrode structure to rotate via the driving assembly, thereby flexibly controlling the direction and position of the electrode structure to achieve the purpose of switching the ablation direction or position.

[0081] In some embodiments, reference Figure 2(b) to Figure 4(b) The pushing component 410 includes a push button 411 , a rotating ring 412 , a fixed shaft 413 and a pushing connecting rod 414 .

[0082] The push button 411 is an arc-shaped structure and is located outside the handle 300. A rotating ring 412 is disposed within the handle 300 and is connected to the push button 411 via a push link 414. Both ends of a fixed shaft 413 pass through the rotating ring 412 and are fixed to the inner wall of the handle 300. The fixed shaft 413 is rotationally connected to the rotating ring 412, and the axial direction of the fixed shaft 413 is parallel to the axial direction of the connecting shaft 110. The push button 411 can be pushed along the outer wall of the handle 300 toward the proximal or distal end. Since both ends of the fixed shaft 413 are fixed to the inner wall of the handle 300, the fixed shaft 413 is stationary. When the push button 411 is pushed, the rotating ring 412 rotates about the fixed shaft 413.

[0083] 2( b ), 2( c ), 5( a ) and 5( b ), the transmission assembly 420 includes a transmission fixed wheel 421 and two pull wires 422 .

[0084] The distal end of the transmission fixed wheel 421 is fixedly connected to the electrode structure 100. Both sides of the transmission fixed wheel 421 are rotationally connected to the connecting rod 200 via the connecting shaft 110. That is, the electrode structure 100 is not directly connected to the connecting rod 200, but is indirectly rotationally connected to the connecting rod 200 via the transmission fixed wheel 421. The proximal ends of two pull wires 422 are disposed opposite each other on the rotating ring 412. The distal ends of the two pull wires 422 pass through the connecting rod 200 and are fixedly connected to the transmission fixed wheels 421, respectively.

[0085] When the push button 411 is pushed, the rotating ring 412 rotates about the fixed rotating shaft 413, and the two pull wires 422 fixed to the rotating ring 412 move accordingly. When the push button 411 is pushed toward the distal end, the two pull wires 422 rotate counterclockwise, driving the transmission fixed wheel 421 to rotate counterclockwise, and in turn driving the electrode structure 100 to rotate counterclockwise. When the push button 411 is pushed toward the proximal end, the two pull wires 422 rotate clockwise, driving the transmission fixed wheel 421 to rotate clockwise, and in turn driving the electrode structure 100 to rotate clockwise.

[0086] In some embodiments, the outer surface of the push button 411 is provided with raised blocks, raised points, or raised strips to increase the friction between the push button 411 and the operator's hand. Referring to Figures 4(a) and 4(b), the outer surface of the push button 411 is provided with a raised strip 415.

[0087] In some embodiments, reference Figure 3(b) to Figure 4(b) Extensions 416 are provided on both sides of the push button 411 along its rotational direction. The thickness of the extensions 416 is smaller than that of the push button 411. The extensions 416 are located outside the handle 300 and move against the outer periphery of the handle 300. When the push button 411 is pushed, the extensions 416 move against the outer periphery of the handle 300, further improving the stability of the fit between the push button 411 and the outer wall of the handle 300.

[0088] In some embodiments, reference Figure 3(b) to Figure 4(b) Extension tubes 417 are provided on both sides of the rotating ring 412 along the axial direction of the fixed rotating shaft 413. The inner diameter of the extension tubes 417 is the same as that of the rotating ring 412, and the inner wall of the extension tubes 417 is flush with the inner wall of the rotating ring 412. The extension tubes 417 are arranged along the axial direction of the fixed rotating shaft 413. Therefore, when the rotating ring 412 is arranged outside the fixed rotating shaft 413, the extension tubes 417 are also located outside the fixed rotating shaft 413, which increases the mating stability of the rotating ring 412 and the fixed rotating shaft 413.

[0089] In some embodiments, reference Figure 3(b) to Figure 4(b) The rotating ring 412 is provided with two connecting through holes 418, the length direction of the connecting through holes 418 being parallel to the axial direction of the connecting rod 200. The proximal end of a pull wire 422 passes through a corresponding connecting through hole 418 and is fixedly connected to the connecting through hole 418. The above fixing method realizes that the two pull wires 422 are relatively fixed to the rotating ring 412.

[0090] In some embodiments, referring to Figures 2(c), 5(a), and 5(b), the distal side of the transmission fixed wheel 421 is a flat surface or an arcuate surface that is concave toward the proximal end. As shown in Figure 5(b), the distal side of the transmission fixed wheel 421 is an arcuate surface 421a that is concave toward the proximal end. The proximal side of the transmission fixed wheel 421 is an arcuate surface 421b. Wire accommodating grooves are excavated on both sides of the outer circumference of the arcuate surface 421b from the proximal end to the distal end. The wire accommodating grooves are connected to the distal side of the transmission fixed wheel 421. The distal ends of the two pull wires 422 extend from the proximal end of the transmission fixed wheel 421 along the two wire accommodating grooves to the distal side of the transmission fixed wheel 421 and merge into one strand that is fixed to the electrode structure 100 on the distal side of the transmission fixed wheel 421.

[0091] The two pull wires 422 and the transmission fixed wheel 421 are fixed in the above-mentioned manner. After the two pull wires 422 wrap around the transmission fixed wheel 421 to the distal side, the two pull wires are combined into one and fixed in the electrode structure 100, making the connection between the two more stable.

[0092] In some embodiments, the electrode structure 100 of the present invention can be rotatably connected to the connecting rod 200 by connecting the rotating shaft 110 and the transmission fixed wheel 421, and preferably an indirect connection with the connecting rod 200 is achieved through a snap joint 500 to adapt to the use scenarios of connecting rods 200 of more specifications or lengths.

[0093] 5( a ) and 5 ( b ), the pulsed electric field ablation device of the present invention further includes a card connector 500 , the proximal end of which is fixedly connected to the connecting rod 200 , and the distal end of the card connector 500 is rotationally connected to the transmission fixed wheel 421 via the connecting shaft 110 .

[0094] In some embodiments, the clamping joint 500 is a U-shaped or Y-shaped clamping joint 500 in cross section, the opening of the clamping joint 500 faces the distal end, and the connecting shaft 110 is disposed at the opening of the clamping joint 500. The U-shaped or Y-shaped clamping joint 500 can achieve a greater rotation of the electrode structure 100.

[0095] In some embodiments, referring to FIG. 5( a ), pin holes are provided at the proximal end of the card joint 500 and the distal end of the connecting rod 200 , and the card joint 500 and the connecting rod 200 are fixedly connected together by a fixing pin 510 .

[0096] In some embodiments, referring to FIG. 5( a ), the electrode structure 100 includes an electrode plate 120 , at least one pair of ablation electrodes 130 , and a plurality of mapping electrodes 140 .

[0097] The electrode plate 120 is rotatably connected to the connecting rod 200 via the connecting shaft 110. When the present invention is provided with a transmission fixed wheel 421, the connecting shaft 110 is disposed on the transmission fixed wheel 421. The proximal end of the electrode plate 120 is fixedly connected to or integrally formed with the distal end of the transmission fixed wheel 421. The electrode plate 120 is rotatably connected to the connecting rod 200 via the connecting shaft 110 and the transmission fixed wheel 421. When the present invention is provided with a clamping joint 500, the transmission fixed wheel 421 is rotatably connected to the clamping joint 500 via the connecting shaft 110. The clamping joint 500 is fixedly connected to the connecting rod 200, and the electrode plate 120 is indirectly connected to the connecting rod 200 via the clamping joint 500.

[0098] Each pair of ablation electrodes 130 is disposed on the electrode plate 120 at a predetermined distance from each other. As shown in FIG5(a), a pair of ablation electrodes 130 is disposed on one side of the electrode plate 120. Alternatively, multiple pairs of ablation electrodes 130 may be disposed on one side or multiple sides of the electrode plate 120, so that one or more pairs of ablation electrodes 130 can be selectively used according to the ablation scenario.

[0099] A number of mapping electrodes 140 are arranged in a row on the electrode plate 120. As shown in FIG5(a), the mapping electrodes 140 are preferably arranged between a pair of ablation electrodes 130. If there are multiple pairs of ablation electrodes 130, multiple rows of mapping electrodes 140 can be provided, and each row of mapping electrodes 140 is correspondingly arranged between a pair of ablation electrodes 130. The mapping electrodes 140 are used to create a three-dimensional cardiac map based on the impedance of the tissue in the heart. Different colors can be used to mark different areas of the heart and the electrical activity therein. The mapping electrodes 140 are used to determine the three-dimensional structure of the heart before ablation. That is, during the operation, medical staff can determine the origin and abnormal area of the abnormal electrical signal that causes arrhythmia in the heart based on the three-dimensional cardiac map, in preparation for subsequent atrial fibrillation ablation, without the need for external mapping equipment, to avoid tissue damage to the patient caused by switching between different devices.

[0100] In some embodiments, the arrangement direction of the mapping electrodes 140 is consistent with the length direction of the ablation electrodes 130 .

[0101] In some embodiments, the electrode plate 120 is a hollow electrode plate 120 formed by snapping together two halves of the electrode plate 120 shell. When the transmission assembly 420 includes two pull wires 422, after the two pull wires 422 wrap around the transmission fixed wheel 421 to the distal side, the two pull wires 422 are combined into one and fixed inside the hollow electrode plate 120, making the connection between the two more stable.

[0102] In some embodiments, each ablation electrode 130 and each mapping electrode 140 is electrically connected to an external high-voltage generator via its corresponding independent wire, which sequentially passes through the interior of the electrode plate 120, the interior of the connecting rod 200, and the interior of the handle 300. If a high-voltage generator connector 600 is provided at the proximal end of the handle 300, each ablation electrode 130 and each mapping electrode 140 is electrically connected to the high-voltage generator connector 600 via its corresponding independent wire, which sequentially passes through the interior of the electrode plate 120, the interior of the connecting rod 200, and the interior of the handle 300.

[0103] In some embodiments, referring to FIG5(a), a plurality of hollow grooves 210 are axially disposed on the connecting rod 200. The hollow grooves 210 connect the interior and exterior of the connecting rod 200, with adjacent hollow grooves 210 circumferentially spaced apart. The plurality of hollow grooves 210 are disposed at least in the distal portion of the connecting rod 200, i.e., no hollow grooves 210 are disposed in the middle and proximal portions of the connecting rod 200. The provision of hollow grooves 210 in the distal portion of the connecting rod 200, as shown in FIG1(a), allows the connecting rod 200 to swing horizontally approximately 45°, enabling multi-directional rotation of the pulsed electric field ablation device, enabling rapid switching of ablation positions, and effectively shortening surgical time by more than 40%.

[0104] In some embodiments, reference Figure 1(a) to Figure 3(b)The handle 300 includes a handle guide section 310, a handle push section 320 and a handle grip section 330 which are sequentially connected from the distal end to the proximal end.

[0105] The handle guide section 310 is connected to the proximal end of the connecting rod 200. The handle push section 320 is equipped with a push assembly 410. At least one section of the outer wall of the handle push section 320 is an arc-shaped section. A push button 411 is provided on the outer side of the arc segment. The push button 411 can be pushed along the arc segment toward the proximal or distal end. The proximal end of the handle grip section 330 is equipped with a high-voltage generator connector 600. The high-voltage generator connector 600 is connected to the electrodes in the electrode structure 100 via wires.

[0106] In some embodiments, referring to FIG. 3( a ) and FIG. 3 ( b ), a limiting groove 311 and a pressing piece 312 are provided inside the handle guide section 310 .

[0107] The retaining groove 311 abuts the proximal end of the connecting rod 200. A pressing plate 312 is located outside the retaining groove 311 and compresses the proximal end of the connecting rod 200. The pressing plate 312 is detachably connected to the inner wall of the handle guide section 310. The retaining groove 311 and the pressing plate 312 respectively restrict the circumferential and axial movement of the connecting rod 200, ensuring that the proximal end of the connecting rod 200 is securely fixed within the handle guide section 310.

[0108] In some embodiments, referring to Figures 3(a) and 3(b), two guide wheels 313 are disposed within the handle guide section 310. These two guide wheels 313 are positioned relative to each other at a predetermined distance, with the gap between the two guide wheels 313 located on the proximal side of the connecting rod 200. Two pull wires 422 extending from the proximal side of the connecting rod 200 pass between the two guide wheels 313 and are then fixedly connected to the rotating ring 412. The guide wheels 313 guide the two pull wires 422 as they move, reducing friction between them and the guide wheels.

[0109] In some embodiments, two guide shafts may be provided inside the handle guide section 310 , each guide shaft being rotatably connected to a guide wheel 313 , so that the two guide wheels 313 may rotate along with the movement of the two pull wires 422 to achieve a guiding function.

[0110] In some embodiments, referring to FIG. 2( a ), the angle α between the axis of the handle gripping section 330 and the axis of the connecting rod 200 is 120° ≤ α ≤ 150°. The center of the rotating ring 412 coincides with the vertex of the angle α. That is, the length of the handle gripping section 330 is not aligned with the length of the connecting rod 200. The handle gripping section 330 is disposed at a relative angle to the proximal end of the handle pushing section 320.

[0111] In some embodiments, the diameter of the high voltage generator connector 600 is greater than 6 mm, preferably 8 mm.

[0112] In some embodiments, the high voltage generator connector 600 is preferably made of copper.

[0113] The high-voltage generator connector 600 is used to connect an external high-voltage generator. In order to prevent voltage breakdown, the diameter of the high-voltage generator connector 600 is designed to be greater than 6 mm, preferably greater than 8 mm, and the connector is preferably made of copper.

[0114] In some embodiments, the handle 300 can be formed by snapping two halves of the handle shell together. A plurality of fixing posts are provided inside one half of the handle shell, and a plurality of corresponding fixing collars are provided inside the other half of the handle shell. The fixing posts are plugged into the fixing collars to achieve the connection between the two halves of the handle shell.

[0115] As shown in FIG. 3( b ), multiple pairs of fixing collars within the handle guide section 310 may be symmetrically arranged in a direction perpendicular to the axial direction, and a gap between a pair of fixing collars accommodates the connecting rod 200 passing therethrough to further define the connecting rod 200 .

[0116] The basic principles, main features, and advantages of the present invention are shown and described above. Those skilled in the art should understand that the present invention is not limited to the foregoing embodiments. The foregoing embodiments and descriptions are merely illustrative of the principles of the present invention. Various changes and modifications may be made to the present invention without departing from the spirit and scope of the present invention. Such changes and modifications are intended to fall within the scope of the present invention. The scope of protection claimed in the present invention is defined by the appended claims and their equivalents.

Claims

1. A pulsed electric field ablation device comprising an electrode structure, a connecting rod, and a handle connected in sequence from distal end to proximal end; It is characterized in that The electrode structure is rotatably connected to the connecting rod via a connecting shaft, and the axial direction of the connecting shaft is perpendicular to the axial direction of the connecting rod; The pulsed electric field ablation device further includes a rotation drive structure, which includes: a pushing assembly, disposed on the handle; a transmission assembly, the proximal end of which is connected to the pushing assembly, and the distal end of which is connected to the electrode structure, wherein the pushing assembly drives the electrode structure to rotate via the transmission assembly; The pushing component includes: A push button with an arc-shaped structure located outside the handle; A rotating ring is provided in the handle and is connected to the push button via a push rod; a fixed rotating shaft, both ends of which pass through the rotating ring and are fixed to the inner wall of the handle, the fixed rotating shaft being rotatably connected to the rotating ring, and the axial direction of the fixed rotating shaft being parallel to the axial direction of the connecting rotating shaft; The transmission assembly comprises: a transmission fixed wheel, the distal end of which is fixedly connected to the electrode structure, and the two sides of which are rotatably connected to the connecting rod via the connecting shaft; The two pulling wires have proximal ends arranged on the rotating ring opposite to each other, and distal ends passing through the connecting rod and fixedly connected to the transmission fixed wheels respectively.

2. The pulsed electric field ablation device according to claim 1, wherein: The push button is provided with extension sections on both sides along its rotation direction. The thickness of the extension sections is smaller than the thickness of the push button. The extension sections are located outside the handle and move against the outer periphery of the handle.

3. The pulsed electric field ablation device according to claim 1, wherein: The rotating ring is provided with two connecting through holes, and the length direction of the connecting through holes is parallel to the axial direction of the connecting rod; The proximal end of one of the pull wires passes through a corresponding one of the connecting through holes and is fixedly connected to the connecting through hole.

4. The pulsed electric field ablation device according to claim 1, wherein: The distal end side of the transmission fixed wheel is a plane or an arc-shaped surface concave toward the proximal end, and the proximal end side of the transmission fixed wheel is a circular arc surface. The outer circumference of the circular arc surface is provided with a wire receiving groove from the proximal end to the distal end, and the wire receiving groove is connected to the distal end side of the transmission fixed wheel; The distal ends of the two pulling wires are respectively extended from the proximal end of the transmission fixed wheel along the two pulling wire accommodating grooves to the distal end side of the transmission fixed wheel and are combined into one strand and fixed in the electrode structure.

5. The pulsed electric field ablation device according to claim 1, wherein: The handle includes: a handle guide section connected to the proximal end of the connecting rod; A handle pushing section is provided with the pushing assembly, at least one section of the outer wall of which is an arc section, and the push button is provided on the outer side of the arc section; A handle grip section has a proximal end provided with a high-voltage generator connector, and the high-voltage generator connector is connected to the electrodes in the electrode structure via a wire.

6. The pulsed electric field ablation device according to claim 5, characterized in that: The interior of the handle guide section is provided with: a limiting groove abutting the proximal end of the connecting rod; A pressing piece is located outside the limiting groove and presses the proximal end of the connecting rod. The pressing piece is detachably connected to the inner wall of the handle guide section.

7. The pulsed electric field ablation device according to claim 5, characterized in that: The interior of the handle guide section is provided with: Two guide wheels are arranged opposite to each other at a preset distance, and a gap between the two guide wheels is located on the proximal side of the connecting rod; The proximal ends of the two pulling wires extend from the proximal end of the connecting rod and pass through between the two guide wheels and are fixedly connected to the rotating ring respectively.

8. The pulsed electric field ablation device according to claim 5, characterized in that: The included angle between the axis of the handle grip section and the axis of the connecting rod is α, 120°≤α≤150°; The center of the rotating ring coincides with the vertex of the angle α.

9. The pulsed electric field ablation device according to any one of claims 1 to 8, characterized in that: The connecting rod is axially provided with: A plurality of hollow grooves are connected to the inside and outside of the connecting rod, and two adjacent hollow grooves are opposite to each other along two sides of the circumference. The plurality of hollow grooves are at least arranged at the far end of the connecting rod.

10. The pulsed electric field ablation device according to claim 1, wherein: The pulsed electric field ablation device further comprises: A card joint, the proximal end of which is fixedly connected to the connecting rod, and the distal end of which is rotationally connected to the transmission fixed wheel via the connecting shaft.

11. The pulsed electric field ablation device according to claim 1, wherein: The electrode structure comprises: an electrode plate, rotatably connected to the connecting rod via the connecting shaft; at least one pair of ablation electrodes, the pair of ablation electrodes being arranged opposite to each other on the electrode plate at a preset distance; A plurality of mapping electrodes are arranged in a row on the electrode plate.

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