Multi-functional pulse electrification apparatus and processing method

Abstract

The present application pertains to the technical field of medical devices and provides a multi-functional pulse electrification apparatus. The apparatus comprises a multi-cavity member and a first pulling member. A portion between the near end and the far end of the multi-cavity member is axially cut to form a plurality of sub-tube parts. The multi-cavity member is configured to form a multi-layer structure of the sub-tube parts and a center member. In addition, a first electrode member is arranged on each of the sub-tube parts, a second electrode member is arranged on the center member, and a third electrode member is arranged on the far end of the multi-cavity member. The apparatus has the functions of single-point ablation and annular ablation of tissues, offers diverse uses, features a simple process method, and is easy to manufacture.

Description

Multifunctional pulse energizing device and its processing method

[0001] Cross-reference to related applications

[0002] This application is based on and claims priority to Chinese patent applications No. 202410662242.0, filed on May 27, 2024, and PCT / CN2024 / 117514, filed on September 6, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This application belongs to the field of medical device technology, and in particular relates to a multifunctional pulse energizing device and its processing method. Background Technology

[0004] Atrial fibrillation (AF) is the most common cardiac arrhythmia and can lead to stroke, cardiomyopathy, and even death in severe cases. The incidence of AF increases with age, and percutaneous catheter ablation is a widely accepted first-line treatment for AF. The purpose of ablation is to destroy the potentially arrhythmic myocardial tissue, blocking the propagation of abnormal electrical signals or disrupting the conduction of abnormal electrical signals in cardiac tissue. Ablation treatment includes several aspects: one is thermal ablation, such as radiofrequency ablation, laser ablation, and microwave ablation; the other is pulsed ablation utilizing the principle of bioelectric perforation. Summary of the Invention

[0005] In some embodiments, this application provides a multifunctional pulse current-carrying device, comprising: a multi-cavity component having a central cavity and a plurality of peripheral cavities surrounding the central cavity, wherein the peripheral cavities and the central cavity both extend axially and are not interconnected; the portion of the multi-cavity component between its proximal and distal ends in the axial direction is cut axially into a plurality of circumferentially separated sub-tubes, each sub-tube containing one of the peripheral cavities; each sub-tube having a through hole communicating with the internal peripheral cavities; and the multi-cavity component having a multi-layer structure at least from each sub-tube toward the distal end, the multi-layer structure including a cut layer for forming each sub-tube and an inner layer for forming the central component; a first electrode component sleeved on each sub-tube for passing a pulse current; a second electrode component disposed at the distal end of the central component for single-point discharge; and a third electrode component disposed at the distal end of the multi-cavity component for single-point discharge.

[0006] In some embodiments, this application also provides a processing method for processing the above-described multifunctional pulse energizing device. The processing method includes: inserting a positioning pin into the central cavity of the multi-cavity component to be processed, and inserting mandrels into each of the surrounding cavities; placing the multi-cavity component on a processing fixture and fixing it, such that a cutting blade on the processing fixture abuts against the portion of the multi-cavity component having the multi-layer structure; driving the multi-cavity component or the cutting blade on the processing fixture to move, so that the cutting blade cuts the multi-cavity component to form a plurality of the sub-tube portions; removing the multi-cavity component from the processing fixture, and withdrawing the positioning pin and each of the mandrels respectively; wherein, when the cutting blade abuts against the portion to be cut on the multi-cavity component, the cutting blade is inserted into the cutting layer and does not contact the inner layer. Attached Figure Description

[0007] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the implementation will be briefly introduced below. Obviously, the drawings described below are some implementations of this application. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0008] Figure 1 is a schematic diagram of the structure of the multifunctional pulse energizing device provided in an embodiment of this application;

[0009] Figure 2-1 is a schematic diagram of a state of the multifunctional pulse power-on device provided in an embodiment of this application;

[0010] Figure 2-2 is a schematic diagram of the structure of a multifunctional pulse energizing device provided in some embodiments of this application;

[0011] Figures 2-3 are schematic diagrams of the structure of a multifunctional pulse energizing device provided in some other embodiments of this application;

[0012] Figure 3 is a schematic diagram of the structure of the multifunctional pulse energizing device provided in the embodiment of this application after omitting the central component;

[0013] Figure 4 is a schematic diagram of the operation of the multifunctional pulse energizing device provided in the embodiment of this application with the sub-tube section in a bent state;

[0014] Figure 5 is a schematic diagram of the sub-tube section of the multifunctional pulse energizing device provided in the embodiment of this application restoring to its initial state;

[0015] Figure 6 is a cross-sectional schematic diagram of the multi-cavity component provided in an embodiment of this application;

[0016] Figure 7 is a cross-sectional schematic diagram of the insulated electrical lead provided in an embodiment of this application;

[0017] Figure 8 is a cross-sectional schematic diagram of the center component provided in an embodiment of this application;

[0018] Figure 9 is a cross-sectional schematic diagram of the electrode provided in an embodiment of this application;

[0019] Figure 10 is a schematic diagram of an electrode with a voltage equalization structure provided in an embodiment of this application;

[0020] Figure 11 is a schematic diagram of an electrode component provided in an embodiment of this application having an equalizing ring disposed thereon;

[0021] Figure 12 is a schematic diagram of the processing tooling provided in an embodiment of this application;

[0022] Figure 13 is a schematic diagram of a multi-cavity component provided in this application, in which a positioning pin and a mandrel are inserted. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of this application clearer, the following detailed description is provided in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the scope of this application.

[0024] The specific technical features described in the specific embodiments can be combined in any suitable manner without contradiction. For example, different combinations of specific technical features can form different embodiments and technical solutions. To avoid unnecessary repetition, the various possible combinations of the specific technical features in this application will not be described separately.

[0025] In the following description, the terms "first," "second," etc., are used merely to distinguish different objects and do not indicate that the objects have the sameness or relationship. It should be understood that the directional descriptions "above," "below," "outside," and "inside" refer to the orientation under normal use conditions, while "left" and "right" refer to the left and right directions shown in the corresponding diagrams, which may or may not be the left and right directions under normal use conditions.

[0026] It should be noted that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Unless otherwise specified, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element. "A plurality of" means two or more.

[0027] Pulsed electric field ablation (PFA) is a novel tissue ablation technique that has emerged in recent years based on high-voltage pulsed energy. It primarily utilizes the principle of irreversible electroporation (IRE), applying a high-voltage pulsed electric field to cells to cause irreversible perforation of the cell membrane, leading to gradual cell necrosis and ultimately tissue ablation. Due to the different electrical properties of tissues and the varying damage thresholds of cells to high-voltage pulsed energy, PFA exhibits good tissue selectivity. For example, myocardial tissue is more sensitive to high-voltage pulsed electric fields, while nerve tissue has a higher tolerance. Therefore, by appropriately selecting the intensity of the high-voltage pulsed electric field, selective tissue ablation can be achieved, such as ablation of tissues near nerves and blood vessels. In addition to the aforementioned tissue selectivity, PFA is generally considered a non-thermal ablation technique, meaning that the ablation process does not generate any heat or tissue temperature rise, eliminating the heat sink effect present in traditional radiofrequency, microwave, and cryoablation methods. Therefore, PFA is considered to have a strong advantage for the ablation of temperature-sensitive tissues (such as tissues near the gallbladder, bile duct, esophagus, etc.), especially when performing ablation for the treatment of atrial fibrillation, PFA has the advantages of short ablation time and protection of the treatment area or blood vessels and other tissues.

[0028] When performing PFA ablation for atrial fibrillation, for some paroxysmal atrial fibrillation cases and all persistent atrial fibrillation cases, it is necessary not only to perform circumferential ablation of the pulmonary veins but also to perform ablation of the posterior wall or roof of the left atrium. Therefore, the PFA catheter used must be able to meet both circumferential and single-point ablation requirements. However, existing PFA catheters have a single function and cannot simultaneously meet different requirements. Furthermore, they are structurally complex and difficult to manufacture.

[0029] This application provides a multifunctional pulsed current device or catheter, which is typically connected to a control device and a high-voltage pulse generator. One end of the multifunctional pulsed current device is inserted into a blood vessel, and the control device (such as an operating handle) is used to move the device along the blood vessel to the tissue to be treated. After the device is in place, a high-voltage, high-frequency pulse voltage generated by the high-voltage pulse generator is delivered to the device, thereby establishing a high-intensity electric field at the site of treatment, forming a region with high current density. The high-voltage pulse electric field acts on the cells, causing irreversible perforation of the cell membrane, leading to gradual cell necrosis and ultimately achieving tissue ablation.

[0030] The term "electroporation" in this article refers to applying an electric field to the cell membrane to alter its permeability to the extracellular environment. The term "irreversible electroporation" in this article refers to applying an electric field to the cell membrane to permanently alter its permeability to the extracellular environment. For example, cells subjected to irreversible electroporation may show the formation of one or more pores in their cell membrane, which persist even after the electric field is removed. The term "proximal 101" in this article refers to the end of the multifunctional pulsed energizing device that is close to the operator or connected to the operation; "distal 102" refers to the end of the multifunctional pulsed energizing device inserted into a blood vessel or close to the tissue to be treated.

[0031] As shown in Figures 1 to 5, an embodiment of this application provides a multifunctional pulse energizing device 1, which includes a multi-cavity component 11 and a first electrode component 12. The multi-cavity component 11 is typically a tubular material with a circular cross-section, and has a central cavity 111 and a plurality of peripheral cavities 112 surrounding the central cavity 111. Each peripheral cavity 112 and the central cavity 111 extends along the axial direction of the multi-cavity component 11 and are not interconnected; for example, the length direction of each peripheral cavity 112 and the central cavity 111 extends approximately along the length direction of the multi-cavity component 11.

[0032] In some other embodiments, the thickness of the multi-cavity component 11 is greater than a preset value, for example, 0.5mm-1.5mm. The specific thickness is to ensure the reliable setting of the central cavity 111 and each surrounding cavity 112, and to avoid the overall diameter being too large, which would be detrimental to delivery within the blood vessel.

[0033] In some embodiments, the portion of the multi-cavity member 11 between its proximal and distal ends is axially cut into multiple sub-tubes 113. These sub-tubes 113 are circumferentially spaced within the multi-cavity member 11, with each sub-tube 113 extending along the length of the multi-cavity member 11. Each sub-tube 113 has a surrounding cavity 112. The distal end of the cut layer 114a is axially movable, allowing each sub-tube 113 to switch between two shapes: extending in a straight line and protruding outwards in a curved form. For example, as shown in FIG. 4, each sub-tube 113 exhibits elastic deformation properties, enabling it to bend under external force. After the external force is removed, as shown in FIG. 5, it can retract under its own elastic deformation force, returning to its initial state or essentially its initial state. Typically, the multi-cavity component 11 is made of polymeric materials that meet medical standards, such as Pebax (thermoplastic nylon elastomer) and PA (polyamide) polymers, which offer high strength, good fracture resistance, and excellent elasticity. The multi-cavity component 11 can be structured with varying hardness at different locations through a gradual transition, such as a gradual decrease in hardness from distal to proximal, thus providing better insertion performance at the distal end to facilitate guiding movement within the blood vessel, while the hardness gradually decreases towards the proximal end for easier bending. The central region of the multi-cavity component 11 has moderate hardness; for example, the hardness of the central region is lower than that of the proximal end to ensure overall strength and delivery. Of course, the hardness of the multi-cavity component 11 can also be set in other ways according to usage requirements, such as designing a higher or lower hardness in a specific area, offering good design flexibility.

[0034] In some embodiments, as shown in Figures 1 and 2-1, at least each sub-tube portion 113 is provided with a multi-layer structure 114 towards its distal end in a multi-cavity member 11 having a cutting layer 114a and an inner layer 114b. The cutting layer 114a is used to form each sub-tube portion 113, and the inner layer 114b is used to form a central member 115. That is, the portion of the multi-cavity member 11 used to form each sub-tube portion 113, and the region extending from that portion towards the distal end, are provided to include at least the cutting layer 114a and the inner layer 114b. Along the radial direction of the multi-cavity member 11, each sub-tube portion 113 is located outside the central member 115, which provides a guide path for the bending deformation of each sub-tube portion 113. Exemplarily, the bending deformation of each sub-tube portion 113 includes deformation from a first configuration (e.g., a straight-line extension state) to a second configuration (e.g., a cage-like shape) or other configurations (e.g., other morphological configurations different from the straight-line extension state and the cage-like shape, or morphological configurations between the straight-line extension state and the cage-like shape). In this configuration, each sub-tube 113 and the central component 115 can be fabricated using a single multi-cavity component 11, eliminating the need for extensive additional structural design and significantly improving the ease of manufacturing the multifunctional pulse energizing device 1. Furthermore, by adjusting the position of each sub-tube 113 on the central component 115, the degree of deformation of each sub-tube 113 can be adjusted, thereby adjusting the fit between each sub-tube 113 and the tissue to achieve a better ablation effect.

[0035] In some other embodiments, the central member 115 (or inner layer 114b) is slidably or movably engaged with the cutting layer 114a forming each sub-tube portion 113. In other words, the central member 115 is slidably disposed in the central cavity 111 of the multi-cavity member 11 (or cutting layer 114a).

[0036] In some embodiments, as shown in Figures 2-1 and 3, a first electrode 12 is provided on each sub-tube portion 113. Exemplarily, the first electrode 12 is sleeved on the corresponding sub-tube portion 113 for applying a pulse current to the multifunctional pulse device 1, for example, applying a pulse current when each sub-tube portion 113 protrudes outward in a bent shape or when each sub-tube portion 113 extends in a straight line.

[0037] In some embodiments, the first electrode 12 disposed on each sub-tube 113 is substantially aligned on the same concentric ring in the circumferential direction of the multi-cavity component 11. This allows for circumferential ablation of the tissue through the combined action of the first electrode 12 at different positions within the circumferential direction of the multi-cavity component 11. For example, as shown in FIG4, when each sub-tube 113 is bent into a cage shape, adjacent first electrode 12 can be discharged sequentially, ultimately forming a complete circumferential ablation, achieving circumferential ablation of the tissue. The phrase "substantially aligned on the same concentric ring" means that the cross-section of each first electrode 12 at its center point, perpendicular to the axis of the multi-cavity component 11, is on the same circle, or within an allowable error range, so that each first electrode 12 can achieve circumferential ablation of the tissue at the same circumferential position.

[0038] In some embodiments, as shown in Figures 1 and 2-1, a second electrode 13 is provided at the distal end of the central member 115, and the number of such electrodes is exemplarily one.

[0039] In some embodiments, a third electrode 14 is provided at the distal end of the cutting layer 114a. In other embodiments, the second electrode 13 can be used as a calibration electrode.

[0040] In some other embodiments, as shown in FIG2-2, a head electrode 16 is provided at the distal end of the center member 115. The head electrode 16 is located at the distal end of the second electrode member 13. In other words, the second electrode 13 is closer to each sub-tube 113 than the head electrode 16.

[0041] In some other embodiments, as shown in Figures 2-3, a return electrode 17 is provided on the multi-cavity component 11, and the return electrode 17 is located on the proximal side of each sub-tube section 113; in other words, the return electrode 17 is located on the multi-cavity component 11 near each sub-tube section 113.

[0042] In this way, single-point ablation of tissue can be achieved by passing a pulse current through the second electrode 13, the third electrode 14, or the tip electrode 16, thereby improving the functionality and meeting the needs of single-point ablation of tissue.

[0043] Optionally, single-point ablation can be achieved by discharging between the second electrode 13 and the third electrode 14; alternatively, single-point ablation can be achieved by discharging through the second electrode 13, covering a smaller area. The "distal end of the central component 115" and "distal end after the connection of each sub-tube 113" mentioned above refer to the end farther from the operator relative to the distance from the operator, or the end that first enters the blood vessel when inserted.

[0044] Alternatively, single-point ablation can be achieved by discharging between the head electrode 16 and the third electrode 14; or single-point ablation can be achieved by discharging through the head electrode 16 to a smaller area.

[0045] Alternatively, single-point ablation can be achieved by discharging between the tip electrode 16 and the return electrode 17; or single-point ablation can be achieved by discharging through the tip electrode 16 to a smaller area.

[0046] Alternatively, single-point ablation can be achieved by discharging between the third electrode 14 and the return electrode 17; or single-point ablation can be achieved by discharging through the third electrode 14 to a smaller area.

[0047] In some embodiments, as shown in Figures 2-1 and 3, the multifunctional pulse energizing device 1 further includes a first pull-out member 15. One end of the first pull-out member 15 is inserted into the central cavity 111 (see Figure 6) and extends to connect with the distal end of the third electrode member 14 and / or the multi-cavity member 11; or one end of the first pull-out member 15 is inserted into the central cavity 111 (see Figure 6) and extends to connect with the distal end of the third electrode member 14 and / or the cutting layer 114a. The other end of the first pull-out member 15 is connected to a control device or is used for handheld use by an operator. In this way, by pulling the first pull-out member 15, force can be transmitted to the distal end of the cutting layer 114a or the third electrode member 14, thereby causing the distal end of the cutting layer 114a to move axially along the central member 115 (in other words, the distal end of the cutting layer 114a slides or is movably sleeved on the outer periphery of the central member 115), thereby switching each sub-tube portion 113 between two shapes: extending in a straight line and protruding outward in a curved shape.

[0048] For example, one end of the first pull member 15 can be connected to the distal end of the cutting layer 114a, allowing the distal end of the cutting layer 114a to slide back and forth on the central member 115. Alternatively, since the third electrode member 14 is located at the distal end of the cutting layer 114a, connecting one end of the first pull member 15 to the third electrode member 14 can also achieve the same effect. Of course, one end of the first pull member 15 can be connected to both the distal end of the cutting layer 114a and the third electrode member 14, similarly achieving the same effect. In this way, by pulling each sub-tube portion 113 outwardly in a curved shape or extending in a straight line by the first pull member 15, a pulsed current is applied to each first electrode member 12, achieving the therapeutic purpose of circumferential ablation of the tissue.

[0049] In some other embodiments, when each sub-tube portion 113 maintains a straight extension, the second electrode 13 is covered, and single-point ablation of the tissue can be achieved by applying a pulsed current to the third electrode 14 or the tip electrode 16. As the curvature of each sub-tube portion 113 gradually decreases and it becomes a straight extension, the second electrode 13, the third electrode 14, or the tip electrode 16 can be used individually or simultaneously for single-point ablation of the tissue, offering flexibility in application.

[0050] In some embodiments, under high-voltage, high-frequency pulses (such as nanosecond pulses or millisecond pulses), the first electrode 12 may easily generate heat due to the contact resistance with blood, causing the surface temperature of the first electrode 12 to rise and triggering the coagulation mechanism of the blood around the first electrode 12, resulting in scabs on the surface of the first electrode 12. The scabs further increase the contact resistance between the electrode and the blood, thus forming a vicious cycle.

[0051] In some embodiments of this application, a through hole (not shown in the figure) is provided on each sub-tube 113 to connect to the surrounding cavity 112. The through hole is disposed adjacent to the first electrode 12 and can be disposed at any position around the contour shape of the first electrode 12. For example, there are multiple through holes, such as 2-6, and the multiple through holes are distributed at intervals along the circumference of the sub-tube 113.

[0052] By injecting fluid (e.g., saline) into each of the surrounding cavities 112 and then allowing the injected fluid to flow out through corresponding through holes, the fluid flowing out from near the first electrode 12 not only improves the conductivity of the surrounding area but also continuously cools the first electrode 12, thereby achieving the purpose of cooling the first electrode 12 and reducing the risk of scab formation. Of course, it is understandable that through holes for fluid passage can also be provided near the second electrode 13 and the third electrode 14, thereby cooling the second electrode 13 and the third electrode 14 and reducing the risk of scab formation, improving the safety and reliability of the treatment. Alternatively, through holes for fluid passage can also be provided near the second electrode 13, the third electrode 14, the tip electrode 16, and / or the return electrode 17.

[0053] In some embodiments, the through hole can be circular, rectangular, elliptical, etc., and optionally circular. The diameter of the through hole is exemplary in the range of 0.05mm-0.5mm. For example, the diameter of the through hole can be 0.05mm, 0.06mm, 0.1mm, 0.13mm, 0.21mm, 0.29mm, 0.32mm, 0.4mm, 0.47mm, 0.5mm, etc. Of course, the diameter of the through hole can also be any other value within the exemplary range of 0.05mm-0.5mm.

[0054] The multifunctional pulsed electrocautery device 1 provided in this application comprises a multi-cavity component 11 ring and a first electrode component 12. The multi-cavity component 11 has a central cavity 111 and multiple peripheral cavities 112 surrounding the central cavity 111. By axially cutting the portion between the proximal and distal ends of the multi-cavity component 11, multiple sub-tubes 113 separated in the circumferential direction are formed. Each sub-tube 113 has a peripheral cavity 112 and a first electrode component 12 is provided in each sub-tube 113, enabling circumferential ablation treatment of tissues. Simultaneously, the portion of the multi-cavity component 11 extending distally from each sub-tube 113 is configured as a multi-layer structure 114 to form each sub-tube 113 and the central component 115. A second electrode component 13 is provided distally to the central component 115, and a third electrode component 14 is provided distally to the cutting layer 114a. Single-point ablation treatment of tissues can be achieved through the second electrode component 13 and / or the third electrode component 14. In this embodiment, the first pull member 15 pulls the distal end of the cutting layer 114a to move axially along the center member 115, thereby causing each sub-tube 113 to switch between two shapes: extending in a straight line and protruding outward in a curved shape. This enables the switching between single-point ablation and ring ablation treatment methods for tissues, resulting in diverse treatment options.

[0055] In some embodiments, the multifunctional pulse energizing device 1 is directly fabricated based on the multi-cavity component 11. The multi-cavity component 11 itself has a simple structure, and its structure meets the usage requirements, thus eliminating the need for excessive other complex structural designs, making the structure of the multifunctional pulse energizing device 1 simpler. Furthermore, it is manufactured by cutting, resulting in a relatively simple and less demanding production process. It is also reproducible, effectively meeting the requirement for the reproducibility of the multifunctional pulse energizing device 1.

[0056] In some embodiments, as shown in Figures 1 and 2-1, the number of sub-tubes 113 formed by cutting the multi-cavity component 11 can be multiple, optionally 3-12, and the specific number can be set according to actual usage requirements. In this way, at the same location, each sub-tube 113 faces a different position in the circumferential direction, thereby enabling circumferential ablation of different parts of the tissue at that location, achieving the purpose of circumferential ablation. This eliminates the need for rotation at the same location to meet the treatment needs of different positions, improving the convenience of treatment and reducing patient discomfort during the treatment process. Simultaneously, the relatively independent sub-tubes 113 formed by cutting have good deformation performance, thereby enhancing the fit with the first pull-out member 15 and the fit between the sub-tubes 113. This facilitates the reduction of the overall outer diameter of the multi-cavity component 11, allowing the overall outer diameter of the multi-cavity component 11 to be, for example, within 3.2 mm, thereby improving its passage within blood vessels and meeting the needs of smaller blood vessels.

[0057] In some embodiments, as shown in Figures 1 and 2-1, the number of first electrode elements 12 disposed on each sub-tube 113 is exemplarily one, thereby enabling better control over the treatment position of the first electrode element 12. Of course, it is understood that in other embodiments, the number of first electrode elements 12 disposed on each sub-tube 113 may be two or more, achieving the purpose of adjusting the treatment range. Exemplarily, the first electrode element 12 disposed on the sub-tube 113 may be inserted from the distal end of the sub-tube 113 and moved to a predetermined position on the sub-tube 113, or it may be formed by wrapping around the predetermined position on the sub-tube 113, providing good flexibility in its placement. When two or more first electrode elements 12 are disposed on each sub-tube 113, the through-hole for saline infusion can be disposed between two first electrodes 12, and closer to the distal first electrode 12.

[0058] In some embodiments, as shown in Figures 3 and 6, the first pull-out member 15 can also be a metal wire such as stainless steel or nickel-titanium. The number of wires can be set according to the usage requirements; for example, the number of metal wires is 2-4. Figure 3 shows three first pull-out members 15. No limitation is made here. One end of the metal wire is inserted into the central cavity 111 and extends towards the distal end of the cutting layer 114a, and can be connected to the third electrode member 14 or the distal end of the cutting layer 114a, or simultaneously connected to the distal ends of both the third electrode member 14 and the cutting layer 114a. The first pull-out member 15 is movable relative to the central member 115, thereby driving the distal end to move, realizing the on-demand switching of each sub-tube section 113 in an outwardly protruding, curved, or cage-shaped state. Furthermore, a PTFE (polytetrafluoroethylene) or PI (polyimide) coating can be applied to the stainless steel or nickel-titanium metal wire to improve the durability and safety of the metal wire, meeting the requirements for medical use.

[0059] In some embodiments, the length direction of the 2-4 first pull-out members 15 extends along the longitudinal axis of the multi-cavity member 11. The 2-4 first pull-out members 15 are arranged close to each other or spaced apart. For example, the 2-4 first pull-out members 15 are arranged side by side in a plane parallel to the longitudinal axis of the multi-cavity member 11, and the side-by-side arrangement can be close to each other or spaced apart; or, the 2-4 first pull-out members 15 are spaced apart along the circumference of the multi-cavity member 11; or, along the cross-sectional direction of the multi-cavity member, the 2-4 inserts are located at different cross-sectional positions, for example, when the number of first pull-out members 15 is at least three, the cross-section formed by the at least three first pull-out members 15 is perpendicular to the length direction of the multi-cavity member 11.

[0060] It can be understood that the length direction of the 2-4 first pull-out members 15 extends along the longitudinal axis of the multi-cavity member 11. This does not mean that any part of the length direction of the first pull-out member 15 extends along the longitudinal axis of the multi-cavity member 11. It can also mean that at least a part of the length direction of the first pull-out member 15 extends along the longitudinal axis of the multi-cavity member 11 (such as the length direction of the part of the first pull-out member 15 near the sub-tube 113 extends along the longitudinal axis of the multi-cavity member 11). Furthermore, at least a part of the length direction of the first pull-out member 15 can be fixed to other structures (such as operating handles) away from the central axis of the multi-cavity member 11.

[0061] In some embodiments, as shown in Figures 1 and 6, each first electrode 12 is connected to a first insulated electrical lead (not shown) disposed within a surrounding cavity 112, through which current is supplied to the first electrode 12. The effective diameter of this first insulated electrical lead is, exemplarily, not less than 0.12 mm, and the overall diameter is, exemplarily, an extremely fine multilayer insulated electrical lead of not more than 0.25 mm. The insulation breakdown strength of the lead is, exemplarily, above 5 kV. Furthermore, the multilayer insulation structure prevents electromagnetic interference during corona discharge and also prevents short circuits caused by conduction during saline infusion. Simultaneously, the length of the sub-tube 113 is, exemplarily, set to 30 mm-80 mm, ensuring that the length of the sub-tube 113 is within a suitable range and that it has a diameter that meets usage requirements when bent, avoiding excessively small lengths that would fail to provide an effective working area or reduce the overall structural strength.

[0062] In some embodiments, as shown in Figures 6 and 8, the central member 115 has multiple axially extending sub-cavities 1151 that communicate with the central cavity 111. At least one sub-cavity 1151 contains a second pull member (not shown) for bending the central member 115; and / or at least another sub-cavity 1151 contains a second insulated electrical lead (not shown) for connection to the second electrode member 13 (see Figure 1). Optionally, the number of sub-cavities 1151 is typically exemplarily set to three or more, and they are arranged in a circumferentially uniformly spaced manner. Since the central member 115 usually enters the blood vessel first during actual treatment, and because blood vessels have diverse shapes and many bends, the central member 115 needs to be able to follow the bends during the pushing process to improve the smoothness of the pushing. Therefore, by employing a plurality of sub-cavities 1151 inside the central component 115, and then providing a movable second pull member in any one of the sub-cavities 1151, with one end of the second pull member connected to the distal end of the central component 115 and the other end extending towards the operator, it can be connected to a control device or pulled by the operator to obtain a pulling force, thereby achieving adjustment of the distal shape of the central component 115 and improving the smoothness of pushing. Simultaneously, at least one of the remaining sub-cavities 1151 is provided with a second insulated electrical lead for connection to the second electrode component 13, thereby enabling the delivery of pulsed current to the second electrode component 13. Furthermore, the remaining sub-cavities 1151 can be used as fluid (e.g., saline) infusion channels, for inputting fluid (e.g., saline) and allowing it to flow out from around the second electrode component 13 through corresponding through holes, thus achieving the purpose of cooling the second electrode component 13 and reducing the risk of scab formation. Of course, it can also be used as a reserved function for future expansion.

[0063] In some embodiments, the multi-cavity component 11 (e.g., the distal or proximal end of the multi-cavity component 11) near each sub-tube portion 113 is also provided with an adjustable bending structure, thereby allowing the shape to be adjusted as needed during pushing, improving the ease of operation of the multi-cavity component 11.

[0064] In some embodiments, the third electrode 14 is disposed at the far end of the cutting layer 114a. In order to enable the third electrode 14 to input pulse current, the third electrode 14 can be connected with a third insulated electrical lead (not shown in the figure) and pass through the surrounding cavity 112 in any of the sub-tubes 113 to connect to the high voltage pulse generator. This does not increase the radial dimension of the multi-cavity component 11 and has good design ingenuity.

[0065] In some embodiments, in order to enable the head electrode 16 to input pulse current, the head electrode 16 can be connected to a fourth insulated electrical lead (not shown in the figure), which passes through the surrounding cavity 112 in any of the sub-tubes 113 and is connected to the high voltage pulse generator without increasing the radial dimension of the multi-cavity component 11, and the design is ingenious.

[0066] In some embodiments, in order to enable the return electrode 17 to input pulse current, the return electrode 17 can be connected to a fifth insulated lead (not shown in the figure), which passes through the surrounding cavity 112 in any of the sub-tubes 113 and is connected to the high voltage pulse generator without increasing the radial dimension of the multi-cavity component 11, and the design is ingenious.

[0067] In some embodiments, the fourth and fifth insulated leads have the same structure as the first insulated lead, the first insulated lead, or the first insulated lead.

[0068] In some embodiments, the multifunctional pulse energizing device further includes a balloon (not shown) for defining the position of the distal end of the cutting layer 114a on the central member 115, the balloon being fitted onto the central member 115, and the inner cavity of the balloon communicating with one of the remaining sub-cavities 1151 to allow the balloon to be filled with an inflation medium through the sub-cavities 1151. For example, the balloon is made of a thin film capable of elastically expanding or contracting. The balloon is fitted onto the central member 115 and positioned between the distal end of the cutting layer 114a and the central member 115 (e.g., the distal end of the central member 115). When the balloon expands, it fills the gap between the distal end of the cutting layer 114a and the central member 115 (e.g., the distal end of the central member 115), thereby positioning the distal end of the cutting layer 114a on the central member 115. This allows for the positioning of the bending state of each sub-tube 113, meeting the need to adjust the bending shape of each sub-tube 113 under different treatment methods. This ingenious design greatly enhances the treatment capabilities of the multifunctional pulsed energizing device. The filling medium can be gas or liquid, etc.

[0069] In some embodiments, as shown in FIG7, both the first and second insulated leads include a conductive core 61 and an insulating layer 62. The conductive core 61 is connected to the corresponding first electrode 12 or second electrode 13. The insulating layer 62 is provided in multiple layers, with each insulating layer 62 successively nested on the conductive core 61 and extending along the length direction of the conductive core 61. Each insulating layer 62 is coaxially disposed with the conductive core 61. For example, the conductive core 61 may be made of copper, with a diameter of not less than 0.12 mm. The extremely fine copper wires constituting the copper core may be insulated with PTFE (polytetrafluoroethylene) or PI (polyimide) coatings to improve the insulation capability of the conductive core 61.

[0070] In some embodiments of this application, each insulating layer 62 may optionally have four layers, so that the overall size of the insulated electrical lead can pass through the corresponding surrounding cavity 112 (see Figure 3) while meeting the overall insulation performance requirements. It is understood that the structure of the third insulated electrical lead is the same as that of the first and second insulated electrical leads, also including a conductive core 61 and insulating layers 62. The conductive core 61 is connected to the third electrode 14. Multiple insulating layers 62 are provided, with each insulating layer 62 successively nested on the conductive core 61. This eliminates the need for separate material selection for the third insulated electrical lead, improving production convenience.

[0071] In some implementations, during PFA (pulsed electric field ablation) surgery, it is necessary to map the intracardiac potential signal to achieve immediate efficacy assessment of electrophysiological examination and ablation treatment. Mapping involves amplifying and acquiring weak electrocardiogram (ECG) signals, while ablation requires the release of high-voltage pulse energy through electrodes. To prevent the high-voltage pulse from damaging the ECG signal detection circuit, in this embodiment, each first electrode 12 is individually wired, and the insulation between all first electrodes 12 is exemplary to reach 5kV or higher, thereby integrating the mapping and ablation functions together. The multiplexing of ablation and mapping functions is achieved through rapid switching within the host unit.

[0072] In some embodiments, as shown in Figures 1 and 6, a braided layer 116 is provided within the multi-cavity member 11. The braided layer 116 extends from the proximal end of the multi-cavity member 11 toward the sub-tube portion 113, but does not extend into the region of the sub-tube portion 113. Specifically, in the radial direction, the braided layer 116 is provided on the outer side of each surrounding cavity 112; for example, in the radial direction, for the portion of the surrounding cavity 112 located on the proximal side of the sub-tube portion 113, the braided layer 116 is provided on the outer side of each surrounding cavity 112.

[0073] The braided layer 116 is provided to improve the torque transmission capability of the multi-cavity component 11, enabling reliable movement of the entire assembly within the blood vessel. This braided layer 116 can be a stainless steel woven mesh, which is strong and possesses suitable elastic bending deformation properties. The braided layer 116 can be provided within the multi-cavity component 11 in an exemplary manner, not continuously in the circumferential direction, but rather outside the locations of the surrounding cavities 112, with each braided layer 116 being unconnected. This not only enhances the strength of the surrounding cavities 112 but also improves the overall structural strength. Furthermore, since the distal end of the cutting layer 114a needs to be cut to form the sub-tube portions 113, the braided layer 116 does not extend into the area of ​​the sub-tube portions 113, thus not affecting the cutting of the multi-cavity component 11.

[0074] In some embodiments, as shown in Figures 1 and 6, a braided layer 116 may be arranged around the circumference of the multi-cavity member 11, with each surrounding cavity 112 located within the area surrounded by the braided layer 116. In this way, with the same braided layer 116 surrounding the outer side of each sub-tube portion 113 in the circumference of the multi-cavity member 11, each sub-tube portion 113 can be protected simultaneously, preventing accidental puncture.

[0075] In some embodiments, in order to adjust the hardness of the multi-cavity component 11 as needed, it can be achieved not only by adjusting the material forming the multi-cavity component 11, but also by adjusting the thickness or density of the braided layer, and there are various ways to set it.

[0076] In some embodiments, the cross-sectional shapes of the surrounding cavities 112 are at least partially the same in the longitudinal direction perpendicular to the multi-cavity member 11, that is, the cross-sectional shapes of the surrounding cavities 112 obtained under the same reference direction are at least partially the same. Insulated leads are passed through the surrounding cavities 112. This arrangement avoids the need for selective insertion of insulated leads due to the different shapes of the surrounding cavities 112, improving installation convenience. Furthermore, setting the inner wall surface of the surrounding cavities 112 as a smooth curved surface reduces frictional resistance, which facilitates the smooth passage of insulated leads. It also facilitates the flow of fluids (e.g., salt water). Exemplarily, setting the inner wall surface of the surrounding cavities 112 as a smooth curved surface can be achieved through a manufacturing process or by providing a PTFE (polytetrafluoroethylene) liner. Similarly, the inner wall surface of the central cavity 111 can also be provided with a PTFE (polytetrafluoroethylene) liner to improve surface smoothness.

[0077] In some embodiments, as shown in Figures 9 to 11, the first electrode 12 has a receiving hole 121 for inserting the sub-tube section 113 (refer to Figure 1), thereby allowing the first electrode 12 to be mounted onto the sub-tube section 113. Furthermore, a voltage equalization structure 122 is provided at both ends of the first electrode 12 on the discharge side; or a voltage equalization ring 123 is connected to both ends of the first electrode 12 on the discharge side, and the voltage equalization structure 122 is provided on the voltage equalization ring 123. Exemplarily, since the multifunctional pulse energizing device 1 needs to withstand a higher voltage, during pulsed electric field ablation surgery, the high-voltage pulse energy is released through the conduit electrode. During high-voltage pulse discharge, to prevent tip discharge or spark discharge at both ends of the first electrode 12, the electric field distribution is designed to be more uniform. In some embodiments of this application, by providing a voltage equalization structure 122 or a voltage equalization ring 123 with a voltage equalization structure 122 on the discharge sides of the first electrode 12, the voltage equalization structure 122 is a smooth arc surface. Under the action of the voltage equalization structure 122, the discharge sides of the first electrode 12 no longer have sharp points, thereby making the electric field distribution more uniform and preventing the formation of severe electric field distortion points at the two ends of the first electrode 12. This ensures that under a high voltage nanosecond pulse with an exemplary voltage of 10kV, the spark discharge caused by the sharp point of the first electrode 12 is reduced or avoided, thus improving the safety and service life of the first electrode 12.

[0078] In some embodiments, a voltage equalization structure 122 or a voltage equalization ring 123 with a voltage equalization structure 122 may also be provided on the discharge sides at both ends of the second electrode 13 and the third electrode 14, thereby reducing or avoiding spark discharge caused by the tips of the second electrode 13 and the third electrode 14 during operation, so as to improve the safety and service life of use.

[0079] In some embodiments, as shown in Figures 1 and 9, at least the cross-sectional shape of the receiving hole 121 is the same as the shape of the outer edge of the cross-section of the sub-tube 113 in the direction perpendicular to the length of the sub-tube 113, and the first electrode 12 is attached to the outer wall of the sub-tube 113. This allows the first electrode 12, after being installed on the sub-tube 113, to fit tightly and flush with the outer surface of the sub-tube 113, ensuring good adhesion to the corresponding tissue and reliable discharge, while also eliminating local protrusions, thus contributing to a reduction in the overall radial dimension of the multi-cavity component 11. Furthermore, in this configuration, the shape of the outer edge of the cross-section of the first electrode 12 can be the same as or different from the shape of the receiving hole 121, and can be configured as needed.

[0080] In some embodiments, the shape of the outer edge of the cross-section of the first electrode 12 is the same as the shape of the outer edge of the cross-section of the sub-tube 113 in the direction perpendicular to the length of the sub-tube 113. This arrangement ensures that the cross-sectional shape of the multi-cavity component 11 as a whole is consistent in the direction perpendicular to the axial direction, and is circular, resulting in good overall aesthetics and facilitating delivery within blood vessels.

[0081] In some embodiments, a positioning sensor (not shown in the figure) for positioning is provided on at least one of the sub-tube sections 113, and the positioning sensor is located near the proximal end of the multi-cavity member 11. This arrangement allows the positioning sensor to pinpoint the location of the sub-tube section 113, facilitating precise treatment. Optionally, the positioning sensor is a magnetic positioning sensor, which offers good positioning performance and is safe to use.

[0082] The multifunctional pulse energizing device 1 provided in some embodiments of this application is fabricated by setting up a multi-cavity component 11. It is directly processed on the basis of the multi-cavity component 11 without the need for too many other complex structural designs, making the structure of the multifunctional pulse energizing device 1 simpler. It is also manufactured by cutting, which is relatively simple and has low requirements, thus well meeting the requirement for the reproducibility of the multifunctional pulse energizing device 1.

[0083] In some embodiments of this application, a ring-shaped ablation treatment of tissue can be achieved by providing a first electrode 12 in each sub-tube 113. By configuring the multi-cavity component 11 into a multi-layer structure 114 at the distal end of each sub-tube 113 to form each sub-tube 113 and a central component 115; and by providing a second electrode 13 at the distal end of the central component 115 and a third electrode 14 at the distal end of the cutting layer 114a, single-point ablation treatment of tissue can be achieved through the second electrode 13 and / or the third electrode 14. The multi-layer insulation design of the insulated leads improves the insulation capability between each first electrode 12, enabling the insulation level of each first electrode 12 to meet the requirements of higher voltage and higher repetition frequency nanosecond pulse discharge, preventing corona discharge and interference signals. The design of the voltage equalization structure 122 on the end faces of each electrode makes the electric field distribution more uniform, effectively preventing spark discharge and greatly reducing heat generation during the discharge process. By designing the first electrode 12 and the sub-tube 113 to fit snugly together, the overall outer diameter of the multi-cavity component 11 is effectively reduced, improving overall transportability and throughput. Furthermore, by connecting each first electrode 12 with a separate, mutually insulated first insulated lead, time-division multiplexing of the first electrode 12 is achieved, allowing ablation and mapping to be performed at different times during PFA surgery using the same first electrode 12.

[0084] In some embodiments of this application, a processing method is also provided for processing the aforementioned multifunctional pulse energizing device 1. As shown in FIG12, this processing method utilizes a processing fixture 2 to process the multi-cavity component 11. The processing fixture 2 includes a worktable 21, a tool holder 22 mounted on the worktable 21, a cutting blade 23 mounted on the tool holder 22, a positioning block 24 for positioning the multi-cavity component 11, a positioning seat 25 for abutting against the multi-cavity component 11, and a push rod 26 for pushing the positioning seat 25. The processing method includes:

[0085] As shown in Figures 12 and 13, a positioning pin 27 is inserted into the central cavity 111 of the multi-cavity part 11 to be processed, and mandrels 28 are inserted into each of the surrounding cavities 112. The positioning pin 27 and mandrels 28 are used to increase the overall hardness of the multi-cavity part 11 during processing, thereby reducing or preventing deformation during processing. The multi-cavity part 11 is then placed on the worktable 21 of the processing fixture 2, with one end abutting against the positioning seat 25. The positioning block 24 presses down on the center of the multi-cavity part 11 for positioning, preventing warping during cutting. After the multi-cavity part 11 is positioned, the cutting blade 23 on the processing fixture 2 abuts against the part of the multi-layered structure 114 on the multi-cavity part 11. After that, the push rod 26 generates a driving force to move the positioning seat 25, thereby causing the multi-cavity component 11 to move toward the cutting blade 23, so that the cutting blade 23 cuts the multi-cavity component 11 to form multiple sub-tube sections 113.

[0086] Of course, in some other embodiments, the multi-cavity component 11 can be prevented from moving by the push rod 26 abutting against the positioning seat 25, and then the cutting blade 23 can be moved toward the multi-cavity component 11 to cut it, so as to form multiple sub-tube sections 113. After the cutting is completed, the positioning block 24 is released, the processed multi-cavity component 11 is removed from the processing fixture 2, and the positioning pin 27 and each mandrel 28 are pulled out respectively.

[0087] In some embodiments, when the cutting blade 23 abuts against the portion to be cut on the multi-cavity component 11, the cutting blade 23 is inserted into the cutting layer 114a without contacting the inner layer 114b to prevent the inner layer 114b from being cut. When cutting the multi-cavity component 11, the number of cutting blades 23 is equal to the number of sub-tube portions 113 to be formed, and the angle of the cutting blade 23 relative to the axis of the multi-cavity component 11 is adjusted so that the cutting blade 23 is tilted at a certain angle relative to the axis of the multi-cavity component 11, thereby reducing cutting resistance and wear on the cutting blade 23. Simultaneously, the angle between the cutting blade 23 and the positioning block 24 can be adjusted so that after the cutting blade 23 is installed in the tool holder 22, the spring pressure always provides a lateral force to keep the cutting blade 23 pressed against the wall of the tool holder 22, ensuring the positional accuracy of the cutting blade 23.

[0088] In some embodiments, when cutting the multi-cavity component 11, the cutting blade 23 may continuously cut from the distal end of the multi-cavity component 11 towards the proximal end to form multiple sub-tube sections 113, with the cut length exemplarily being 30mm-80mm. Thus, the distal end of each sub-tube section 113 is a free end. Then, a first electrode 12 is inserted through the end of each sub-tube section 113, so that each sub-tube section 113 is fitted with a first electrode 12, and a first insulated electrical lead is connected to each first electrode 12. The first insulated electrical lead is passed through the surrounding cavity 112 of the sub-tube section 113 containing the first electrode 12, and then extends towards the proximal end of the multi-cavity component 11 until it can be connected to the high-voltage pulse generator.

[0089] In some embodiments, when cutting the multi-cavity component 11, the cutting blade 23 may continuously cut from a predetermined distance from the distal end towards the proximal end to form multiple sub-tube sections 113, with the cutting length exemplarily being 30mm-80mm. Exemplarily, in this cutting method, the cutting blade 23 does not start cutting directly from the distal end, but rather at a predetermined distance from the distal end. This predetermined distance can be exemplarily between 5mm and 15mm, so that the distal ends of the formed sub-tube sections 113 do not disperse after cutting. Of course, other predetermined distances are also possible. After cutting to form each sub-tube section 113, a first electrode component 12 is wrapped around each sub-tube section 113, and a first insulated electrical lead is connected to each first electrode component 12. The first insulated electrical lead is threaded through the surrounding cavity 112 of the sub-tube section 113 containing the first electrode component 12, and then extends towards the proximal end of the pulse energizing device 1 until it can be connected to the high-voltage pulse generator.

[0090] In some embodiments, after the first electrode 12 is installed, a second electrode 13 is connected to the distal end of the central member 115, and a second insulated electrical lead connected to the second electrode 13 passes through a sub-cavity 1151 inside the central member 115 and is connected to a high-voltage pulse generator. Furthermore, a third electrode 14 is connected to the distal end of the cut layer 114a, and a third insulated electrical lead connected to the third electrode 14 passes through a surrounding cavity 112 in any sub-tube 113 and is connected to a high-voltage pulse generator. For example, if each sub-tube 113 has a free end after cutting, the free ends of each sub-tube 113 must first be connected together around the central member 115 and be able to reciprocate relative to the central member 115 before the third electrode 14 is installed.

[0091] In one embodiment, after the first electrode 12 is installed, one end of the first pull-out member 15 is inserted into the central cavity 111 of the multi-cavity member 11 and extends to be fixedly connected to the distal end of the third electrode 14 or the cutting layer 114a, or extends to be fixedly connected to the distal end of the third electrode 14 and the cutting layer 114a. This allows the distal end of the cutting layer 114a to move axially along the central member 115 by pulling the first pull-out member 15, thereby switching between two shapes: one extending in a straight line and the other protruding outward in a curved shape. For example, when cutting is performed from the distal end of the multi-cavity member 11, after the first electrode 12 is installed on each sub-tube 113, one end of the first pull-out member 15 can be inserted into the central cavity 111 of the multi-cavity member 11, and then the free ends of each sub-tube 113 can be connected to the distal end of the first pull-out member 15. Alternatively, the free ends of each sub-tube section 113 can be connected together around the central member 115, and a third electrode member 14 can be provided at the connection point, so that the first pull member 15 is connected to the third electrode member 14. Alternatively, the third pull member can be connected to both the distal end of the cutting layer 114a and the third electrode member 14 at the same time, thereby completing the manufacturing process.

[0092] In other embodiments, when the cutting blade 23 continuously cuts from a predetermined distance between its distal end and the distal end of the cutting layer 114a toward the proximal end of the pulse energizing device 1, one end of the first pull-out member 15 can be first inserted into the central cavity 111 of the multi-cavity member 11 and bonded or fused together with the distal end of the cutting layer 114a, and then cut to form each sub-tube portion 113. This provides diverse processing methods and good flexibility.

[0093] The processing method provided in some embodiments of this application involves first inserting a positioning pin 27 into the central cavity 111, then inserting mandrels 28 into each of the surrounding cavities 112, and finally placing the multi-cavity component 11 to be cut on the processing fixture 2 for cutting to form each sub-tube section 113. Then, a first electrode component 12 and a first pull-out component 15 are provided on each sub-tube section 113, so that the distal end of the first pull-out component 15 is connected to the distal end of the cutting layer 114a. This completes the production of the multifunctional pulse energizing device 1. This processing method achieves production through cutting, and the process is relatively simple and has low requirements. It also has good repeatability, well meeting the requirement for reproducibility of the multifunctional pulse energizing device 1.

[0094] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this application should be included within the scope of protection of this application. Therefore, the scope of protection of this application should be determined by the scope of the claims.

Claims

1. A multi-functional pulse energizing device, wherein, The application relates to a multifunctional pulse power supply device. The multifunctional pulse power supply device comprises a multi-cavity piece, a first electrode piece, a second electrode piece and a third electrode piece. The multi-cavity piece has a central cavity and a plurality of surrounding cavities surrounding the central cavity, and the surrounding cavities and the central cavity are axially extended and not communicated with each other. The multi-cavity piece is axially cut into a plurality of circumferentially separated sub-tube parts between the proximal end and the distal end of the multi-cavity piece in the axial direction. Each of the sub-tube parts has one of the surrounding cavities inside.

2. The multi-functional pulse power supply device according to claim 1, wherein, Each of the sub-tube parts is provided with a through hole communicating with the surrounding cavity.

3. The multi-functional pulse power supply device according to claims 1-2, wherein, At least the sub-tube parts towards the distal end of the multi-cavity piece are provided with a multi-layer structure.

4. The multi-functional pulse power supply device according to claim 1, wherein, The multi-layer structure comprises a cutting layer for forming the sub-tube parts and an inner layer for forming a central piece.

5. The multi-functional pulse power supply device according to claim 4, wherein, The first electrode piece is sleeved on each of the sub-tube parts for passing in pulse current.

6. The multi-functional pulse power supply device according to any one of claims 1 to 5, wherein, The second electrode piece is arranged at the distal end of the central piece for single-point discharge.

7. The multi-functional pulsed energizing device of any of claims 1-6, wherein, The third electrode piece is arranged at the distal end of the cutting layer for single-point discharge.

8. The multi-functional pulse power supply device according to claim 7, wherein The distal end of the central piece is provided with a head-end electrode.

9. The multi-functional pulse power device of claim 8, wherein, The head-end electrode is located on the distal end side of the second electrode piece.

10. The multi-functional impulse power device of claim 1, wherein, The head-end electrode is used for single-point discharge.

11. The multi-functional pulsed power device of any of claims 1-10, wherein, The multi-cavity piece is provided with a return electrode. The return electrode is located on the proximal end side of the sub-tube parts.

12. The multi-functional pulsed energizing device of claim 11, wherein, The return electrode is used for single-point discharge.

13. The multi-functional pulsed energizing device of any of claims 11-12, wherein, The thickness of the multi-cavity piece is greater than a preset value. The preset value is 0.5mm-1.5mm. The first electrode piece is used for passing in pulse current in the state that the sub-tube parts outwardly protrude in a curved shape or extend along a straight line. The multifunctional pulse power supply device further comprises a first pulling piece. One end of the first pulling piece is inserted into the central cavity and extends to be fixedly connected with the third electrode piece and / or the cutting layer. The first pulling piece is used for moving the distal end of the cutting layer along the axial direction of the central piece to drive the sub-tube parts to switch between the shape of extending along a straight line and the shape of outwardly protruding in a curved shape. The first pulling piece is a metal wire. The number of the metal wires is 2-4. Each of the first electrode pieces is connected with a first insulated electric lead wire arranged in the surrounding cavity. The length of the sub-tube parts is 30mm-80mm. The central piece has a plurality of sub-cavities axially extending and communicating with the central cavity. At least one of the sub-cavities is provided with a second pulling piece for bending the central piece. At least another one of the sub-cavities is provided with a second insulated electric lead wire for being connected with the second electrode piece. The multifunctional pulse power supply device further comprises a balloon for limiting the moving position of the distal end of the cutting layer on the central piece. The balloon is sleeved on the central piece. The inner cavity of the balloon communicates with the remaining one of the sub-cavities to pass in filling medium into the balloon through the sub-cavity. The first insulated electric lead wire and the second insulated electric lead wire each comprise a conductive core and an insulating layer. The conductive core is connected with the corresponding first electrode piece or second electrode piece. The insulating layer is provided with a plurality of layers. Each of the insulating layers is coaxially arranged on the conductive core.

14. The multi-functional pulsed power device of any one of claims 1-13, wherein, The multi-cavity piece is provided with a braided layer, which extends from the proximal end of the multi-cavity piece towards the direction close to the sub-tube part and does not extend into the region of the sub-tube part.

15. The multi-functional pulsed power device of any one of claims 1-14, wherein, In the radial direction, the outer side of each of the surrounding cavities is provided with the braided layer.

16. The multi-functional pulsed energizing device of any of claims 14-15, wherein, The braided layer is circumferentially arranged on the multi-cavity piece, and each of the surrounding cavities is located in the region surrounded by the braided layer.

17. The multi-functional pulsed energizing device of any one of claims 1-16, wherein, In the radial direction, for the region part of each of the surrounding cavities on the proximal side of the sub-tube part, the outer side of each of the surrounding cavities is provided with the braided layer.

18. The multi-functional pulsed energizing device of claim 1, wherein, The cross-sectional shape of each of the surrounding cavities is at least partially the same in the direction perpendicular to the length direction of the multi-cavity piece; wherein the inner wall surface of the surrounding cavity is a smooth curved surface.

19. The multi-functional pulsed power device of any one of claims 1 to 18, wherein, The first electrode piece is formed with a receiving hole for inserting the sub-tube part; wherein the discharge side of the first electrode piece is provided with a pressure equalizing structure; or the discharge side of the first electrode piece is connected with a pressure equalizing ring provided with a pressure equalizing structure.

20. The multi-functional pulsed energizing device of claim 19, wherein, In the direction perpendicular to the length direction of the sub-tube part, at least the cross-sectional shape of the receiving hole is the same as the shape of the cross-sectional outer edge of the sub-tube part, and the first electrode piece is attached to the outer wall of the sub-tube part.

21. The multi-functional pulsed energizing device of claim 19, wherein, In the direction perpendicular to the length direction of the sub-tube part, the shape of the cross-sectional outer edge of the first electrode piece is the same as the shape of the cross-sectional outer edge of the sub-tube part.

22. A processing method for the multi-functional pulse energizing device as claimed in any one of claims 1 to 21, wherein, The processing method comprises: inserting a positioning needle into the central cavity of the multi-cavity piece to be processed, and inserting a core rod into each surrounding cavity, respectively; placing the multi-cavity piece on a processing tool and fixing, so that the cutting knife on the processing tool abuts against the part of the multi-cavity piece with the multi-layer structure; driving the cutting knife on the processing tool or the multi-cavity piece to move, so that the cutting knife cuts the multi-cavity piece to form a plurality of sub-tube parts; taking out the multi-cavity piece from the processing tool, and extracting the positioning needle and each core rod, respectively; wherein when the cutting knife abuts against the part to be cut of the multi-cavity piece, the cutting knife is inserted into the cutting layer and does not contact the inner layer.

23. The method of processing of claim 22, wherein, The cutting knife continuously cuts from the end of the distal end to the proximal end to form a plurality of sub-tube parts, and the cutting length is 30-80 mm.

24. The method of processing of claim 23, wherein, Each of the sub-tube parts is respectively sleeved with the first electrode piece, and a first insulating electric lead wire is connected to each of the first electrode pieces, and the first insulating electric lead wire is arranged in the surrounding cavity of the sub-tube part where the first electrode piece is located.

25. The processing method as described in claim 22, wherein, The cutting knife continuously cuts from a preset distance away from the end of the distal end to the proximal end, and the cutting length is 30-80 mm.

26. The method of processing of claim 25, wherein, Each of the sub-tube parts is respectively wrapped with the first electrode piece, and a first insulating electric lead wire is connected to each of the first electrode pieces, and the first insulating electric lead wire is arranged in the surrounding cavity of the sub-tube part where the first electrode piece is located.

27. The method of processing of claim 22 or 25, wherein, The second electrode piece is connected to the distal end of the central piece, and the third electrode piece is connected to the distal end of the multi-cavity piece.

28. The method of processing of claim 27, wherein, One end of the first pulling piece is arranged in the central cavity of the multi-cavity piece and extends to the third electrode piece.

29. The method of processing according to claim 27 or 28, wherein, One end of the first puller is threaded in the center cavity of the multi-cavity member and extends to connect with the distal end of the cutting layer.

Images