Self-expanding pulse energization device and processing method

Abstract

The present application is applicable to the technical field of medical instruments, and provides a self-expanding pulse energization device, comprising a multi-cavity piece, shape memory pieces, and electrode pieces. The multi-cavity piece is axially cut to form a plurality of sub-tube parts, each sub-tube part being provided with the shape memory piece and the electrode piece. The present application, by arranging the multi-cavity piece and directly processing on the basis of the multi-cavity piece, features a simple structure, an ingenious design, and a simple processing method, enabling the self-expanding pulse energization device to be reproducible.

Description

Self-expanding pulsed energizing device and processing method

[0001] Cross-reference to related applications

[0002] This application is based on and claims priority to Chinese Patent Application No. 202410662250.5, filed on May 27, 2024, the entire contents of which are incorporated herein by reference. TECHNICAL FIELD

[0003] The present application belongs to the technical field of medical devices, and particularly relates to a self-expanding pulsed energizing device and a processing method. BACKGROUND

[0004] Atrial fibrillation is the most common arrhythmia, which can lead to stroke, cardiomyopathy, and even death in severe cases. With increasing age, the incidence of atrial fibrillation is increasing, and percutaneous catheter ablation is the first-line treatment for atrial fibrillation and has been widely recognized. The purpose of ablation is to destroy the underlying arrhythmic myocardial tissue, prevent abnormal electrical signals from propagating, or destroy abnormal electrical signals in heart tissue. Ablation therapy includes multiple aspects: one is thermal ablation, such as radiofrequency ablation, laser ablation, microwave ablation, etc., and the other is pulse ablation using the principle of bioelectric perforation. SUMMARY

[0005] In some embodiments, the self-expanding pulsed energizing device provided by the present application comprises: a multi-cavity member having a central cavity and a plurality of peripheral cavities surrounding the central cavity, each of the peripheral cavities and the central cavity extends axially and is not in communication with each other, the wall thickness of the multi-cavity member is greater than a predetermined value, and the portion of the multi-cavity member between the proximal end and the distal end in the axial direction is cut axially into a plurality of sub-tube portions separated in the circumferential direction, each of the sub-tube portions has one of the peripheral cavities inside, and a through hole communicating with the peripheral cavity is formed on each of the sub-tube portions; a shape memory member arranged in each of the sub-tube portions, the shape memory member is provided with a predetermined shape to drive each of the sub-tube portions to protrude outward in a curved shape; and an electrode member sleeved on each of the sub-tube portions for passing a pulse current in the state that each of the sub-tube portions protrudes outward in a curved shape.

[0006] In some embodiments, the application also provides a processing method for processing the self-expanding pulse energizing device described above, the processing method comprising: inserting a positioning needle into a center cavity of a 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 a cutting knife on the processing tool abuts against a part to be cut on the multi-cavity piece; 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; and taking out the multi-cavity piece from the processing tool, and extracting the positioning needle and the core rod respectively. BRIEF DESCRIPTION OF DRAWINGS

[0007] In order to more clearly illustrate the technical solutions of the embodiments of the application, the drawings needed to be used in the embodiments will be briefly introduced as follows. Obviously, the drawings in the following description are some embodiments of the application, and other drawings can also be obtained by those skilled in the art without any creative effort on the basis of these drawings.

[0008] Fig. 1 is a structural schematic diagram of a self-expanding pulse energizing device provided by an embodiment of the application;

[0009] Fig. 2 is a structural schematic diagram of a shape memory member provided by an embodiment of the application;

[0010] Fig. 3 is a sectional schematic diagram of a multi-cavity piece close to a proximal end provided by an embodiment of the application;

[0011] Fig. 4 is a sectional schematic diagram of an insulating electric lead provided by an embodiment of the application;

[0012] Fig. 5 is a sectional schematic diagram of an electrode member provided by an embodiment of the application;

[0013] Fig. 6 is a schematic diagram of an electrode member provided by an embodiment of the application, wherein a voltage equalizing structure is arranged on the electrode member;

[0014] Fig. 7 is a schematic diagram of an electrode member provided by an embodiment of the application, wherein a voltage equalizing ring is arranged on the electrode member;

[0015] Fig. 8 is a structural schematic diagram of a processing tool provided by an embodiment of the application;

[0016] Fig. 9 is a schematic diagram of a multi-cavity piece provided by an embodiment of the application, wherein a positioning needle and a core rod are inserted into the multi-cavity piece.

[0017] Explanation of reference signs:

[0018] 1. A self-expanding pulse energizing device; 101. proximal end; 102. distal end; 11. multi-lumen member; 111. central lumen; 112. peripheral lumens; 113. sub-tube portion; 114. braided layer; 12. shape memory member; 13. electrode member; 131. receiving aperture; 132. pressure equalizing structure; 133. pressure equalizing ring; 14. insulated electrical lead; 141. conductive core; 142. insulating layer;

[0019] 2. A processing tool; 21. worktable; 22. tool holder; 23. cutting tool; 24. positioning block; 25. push rod; 27. positioning pin; 28. core rod. DETAILED DESCRIPTION

[0020] In order to make the objectives, technical solutions and advantages of the present application clearer, the present application will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present application and not intended to limit the present application.

[0021] In the specific embodiments, each specific technical feature described can be combined in any suitable manner without contradiction, for example, different embodiments and technical solutions can be formed by combining different specific technical features. In order to avoid unnecessary repetition, various possible combinations of each specific technical feature in the present application are not described again.

[0022] In the following description, the terms "first", "second", and the like are merely used to distinguish different objects, and do not mean that the objects have the same or related relationship. It should be understood that the terms "upper", "lower", "outer", "inner", "left", and "right" are the positions in the normal use state, and the "left" and "right" directions shown in the specific schematic diagram can be the left and right directions in the normal use state or not.

[0023] It should be noted that the terms "include", "contain" or any other variants thereof are intended to cover non-exclusive inclusion, so that the process, method, article or device including a series of elements not only includes those elements, but also includes other elements not explicitly listed or inherent to such process, method, article or device. Without more limitations, the element defined by the statement "includes one" does not exclude the existence of another identical element in the process, method, article or device including the element. "Multiple" means greater than or equal to two.

[0024] Pulse field ablation (PFA) is a new type of tissue ablation method based on high-voltage pulse energy in recent years. It mainly uses the principle of irreversible electroporation (IRE) to make the cell membrane produce irreversible perforation by high-voltage pulse electric field, so that the cells gradually necrosis, and finally realize the purpose of tissue ablation. Because of the different electrical properties of tissues and the damage threshold of cells to high-voltage pulse energy, PFA has good tissue selectivity. For example, myocardial tissue is more sensitive to high-voltage pulse electric field, while nerve tissue has higher tolerance to pulse electric field. Therefore, by reasonably selecting the intensity of high-voltage pulse electric field, selective tissue ablation can be achieved, such as tissue ablation near nerves and blood vessels. In addition to the above-mentioned tissue selectivity, PFA is generally considered as a non-thermal ablation technology, that is, the ablation process does not produce any heat and tissue temperature rise, which can eliminate the heat sink effect existing in traditional radiofrequency, microwave, and cryoablation ablation methods. Therefore, PFA is considered to have strong advantages for temperature-sensitive tissue ablation (such as tissues near gallbladder, bile duct, esophagus, etc.), especially in the treatment of atrial fibrillation ablation, PFA has the advantages of short ablation time and protection of treatment area or blood vessel tissue.

[0025] When performing PFA ablation of atrial fibrillation, it is necessary to quickly perform circumferential pulmonary vein ablation and ensure the adhesion of the catheter electrode, so the design of the PFA catheter is crucial. However, the existing PFA catheter structure is complex, and the production and processing are difficult, which increases the difficulty of producing the PFA catheter.

[0026] The self-expanding pulse power device or catheter provided by the embodiments of the present application is usually connected with a control device and a high-voltage pulse generator. By inserting one end of the self-expanding pulse power device into a blood vessel and operating the control device (such as a handle), the self-expanding pulse power device can be moved along the blood vessel into the tissue to be treated. After the self-expanding pulse power device is delivered to the site, the high-voltage pulse generator generates high-voltage and high-frequency pulse voltage to the self-expanding pulse power device, thereby establishing a high-intensity electric field at the tissue to be treated and forming a region with high current density. By the action of high-voltage pulse electric field on cells, the cell membrane produces irreversible perforation, so that the cells gradually necrosis, and finally realize the purpose of tissue ablation.

[0027] The term "electroporation" herein refers to the application of an electric field to a cell membrane to change the permeability of the cell membrane to the extracellular environment. The term "irreversible electroporation" herein refers to the application of an electric field to a cell membrane to permanently or near-permanently change the permeability of the cell membrane to the extracellular environment. For example, a cell subjected to irreversible electroporation can be observed to have one or more pores formed in its cell membrane that remain after the electric field is removed. The term "proximal" herein refers to the end of the self-expanding pulsed electroporation device closest to the operator or connected to the operation; the term "distal" refers to the end of the self-expanding pulsed electroporation device inserted into the blood vessel or closest to the tissue to be treated.

[0028] As shown in FIGS. 1-3, a self-expanding pulsed electroporation device 1 according to embodiments of the present application includes a multi-cavity member 11, a shape memory member 12, and an electrode member 13. The multi-cavity member 11 is generally a tubular material with a circular cross-sectional shape, and the interior of the multi-cavity member 11 has a central cavity 111 and a plurality of surrounding cavities 112 surrounding the central cavity 111. Each of the surrounding cavities 112 and the central cavity 111 extends along the axial direction of the multi-cavity member 11 and is not in communication with each other; for example, the length direction of each of the surrounding cavities 112 and the central cavity 111 extends along the length direction of the multi-cavity member 11.

[0029] In some other embodiments, the wall thickness of the multi-cavity member 11 is greater than a predetermined value, for example, 0.5 mm-1.5 mm. The specific wall thickness is suitable to satisfy the reliable arrangement of the central cavity 111 and the surrounding cavities 112, and does not cause the overall diameter to be too large to be disadvantageous for delivery in the blood vessel.

[0030] In some embodiments, the multi-lumen member 11 is cut into a plurality of sub-tube portions 113 along the axial direction between the proximal end 101 and the distal end 102, and the plurality of sub-tube portions 113 are arranged in a circumferential direction of the multi-lumen member 11, and each sub-tube portion 113 has a length direction along the length direction of the multi-lumen member 11. Each sub-tube portion 113 has a surrounding lumen 112 inside, and the distal end of the multi-lumen member is movable along the axial direction, so that each sub-tube portion 113 switches between a linearly extending shape and a curved shape protruding outward. Each sub-tube portion 113 has an elastic deformation performance, and can be bent under the action of an external force, and can automatically restore to an initial state or a substantially initial state under the action of an elastic deformation force of the sub-tube portion 113 itself after the external force disappears. Generally, the multi-lumen member 11 is made of a high polymer material meeting medical use standards, such as Pebax (thermoplastic nylon elastomer) and PA (polyamide) high polymer materials, which have high strength, good anti-fracture and elastic performance. The multi-lumen member 11 can be formed in a gradually transitioned manner to have different hardnesses at different positions, such as gradually decreasing from the distal end 102 to the proximal end 101, so that the distal end 102 has good insertion performance, facilitating the movement in the blood vessel, and gradually decreasing near the proximal end 101, facilitating bending. The middle region of the multi-lumen member 11 has moderate hardness, for example, the hardness of the middle region of the multi-lumen member 11 is less than the hardness of the proximal end of the multi-lumen member 11, to ensure the overall strength and pushability. Of course, the hardness of the multi-lumen member 11 can be set in other forms according to use requirements, such as designing the hardness of a local position to be larger or smaller, and the design flexibility is good.

[0031] In some embodiments, as shown in FIGS. 1-3, a shape memory member 12 is provided on each sub-tube portion 113, in other words, each sub-tube portion 113 is provided with a shape memory member 12. The shape memory member 12 is provided with a predetermined shape, so that each sub-tube portion 113 protrudes outward (or self-expands) in a curved shape. Specifically, the shape memory member 12 is provided in any position of the sub-tube portion 113 and extends along the length direction of the sub-tube portion 113, for example, can be embedded in the solid portion of the sub-tube portion 113, or can be provided in the surrounding cavity 112 inside the sub-tube portion 113, and the position of the shape memory member 12 is fixed. The shape memory member 12 is a special metal material that can deform plastically at a certain temperature range (for example, -70°C-0°C), and can restore the original macroscopic shape at another temperature range (for example, 0°C-30°C), such as nickel-titanium memory alloy or copper-based memory alloy. Moreover, the shape memory member 12 can be provided with a PTFE (polytetrafluoroethylene) or PI (polyimide) coating, which can improve the durability of the shape memory member 12 and enable the shape memory member 12 to have high insulation safety, meeting the medical use requirements. The shape memory member 12 is thermoplastically preformed into a curved shape, then transformed into a straight line shape by external force, and then provided on the sub-tube portion 113. After the shape constraint of the external force is removed, the shape memory member 12 can automatically restore to the predetermined shape, thereby enabling the sub-tube portion 113 to protrude outward in a curved shape. The electrode member 13 is sleeved on each sub-tube portion 113, for example, to pass through the pulse current in the state that the sub-tube portion 113 protrudes outward in a curved shape or in the state that the sub-tube portion 113 extends along a straight line. This enables the ablation treatment of the tissue in the state that each sub-tube portion 113 protrudes outward in a curved shape or in the state that each sub-tube portion 113 extends along a straight line. Thus, in this state, the electrode member 13 provided on each sub-tube portion 113 discharges to achieve the purpose of annular ablation of the tissue.

[0032] In some embodiments, the electrode member 13 is prone to generate heat due to the contact resistance between the electrode member 13 and the blood under high-voltage and high-frequency pulses (such as nanosecond pulses or millisecond pulses), which causes the surface temperature of the electrode member 13 to rise and promote the blood clotting mechanism of the blood around the electrode member 13, resulting in scab formation on the surface of the electrode member 13, which further increases the contact resistance between the electrode and the blood, thus forming a vicious cycle. In some embodiments of the present application, a through hole (not shown in the figure) is formed on each sub-tube portion 113 to communicate with the surrounding cavity 112, and the through hole is arranged adjacent to the electrode member 13. By injecting fluid (such as saline) into each surrounding cavity 112 and then causing the injected fluid to flow out of the corresponding through hole, the fluid flowing out of the vicinity of the electrode member 13 not only improves the electrical conductivity of the surrounding area, but also continuously cools the electrode member 13, thereby achieving the purpose of cooling the electrode member 13 and reducing the risk of scab formation.

[0033] In other embodiments, the number of through holes is 2-6, for example, 4, and the plurality of through holes are spaced apart along the circumference of the sub-tube portion 113; for example, the plurality of through holes are uniformly spaced apart along the circumference of the sub-tube portion 113.

[0034] In some embodiments of the present application, a self-expanding pulse energizing device 1 is provided by arranging a multi-cavity member 11, a shape memory member 12, and an electrode member 13. The multi-cavity member 11 has a central cavity 111 and a plurality of surrounding cavities 112 surrounding the central cavity 111. The multi-cavity member 11 is cut into a plurality of sub-tube portions 113 along the axial direction between the proximal end 101 and the distal end 102 of the multi-cavity member 11. The plurality of sub-tube portions 113 are arranged spaced apart in the circumferential direction of the multi-cavity member 11. The length direction of each sub-tube portion 113 is arranged along the length direction of the multi-cavity member 11. Each sub-tube portion 113 has one surrounding cavity 112 inside, and the electrode member 13 is arranged in each sub-tube portion 113. Meanwhile, the shape memory member 12 is arranged in each sub-tube portion 113, so that under the action of the shape memory member 12, the sub-tube portion 113 can automatically deform to protrude outward in a curved shape. The sub-tube portion 113 is inserted with pulse current in a state of protruding outward in a curved shape or in a state of extending along a straight line to achieve discharge and achieve the purpose of tissue ablation. In the embodiments of the present application, the multi-cavity member 11 is directly machined on the basis of the multi-cavity member 11. The multi-cavity member 11 itself has a simple structure and the structure can meet the use requirements, so that no additional complex structure design is needed, the self-expanding pulse energizing device 1 has a simple structure, and the shape memory member is arranged to automatically deform each sub-tube portion 113 into a predetermined shape, which is a clever design. The machining and production are realized by cutting, the production process is simple, the operation requirement is low, and it can be reproduced, which well meets the reproducible requirement of the self-expanding pulse energizing device 1.

[0035] In some embodiments, as shown in FIG. 1, the number of each sub-tube part 113 formed by cutting the multi-cavity part 11 can be set to be multiple, optionally 3-12, and the specific number can be set according to actual use requirements. In this way, at the same position, each sub-tube part 113 respectively faces different positions in the circumferential direction, so as to be able to discharge and ablate different parts of the tissue at the position in the circumferential direction, without the need to rotate at the same position to meet the treatment needs of different positions, thereby improving the convenience of treatment and reducing the degree of discomfort of the patient during treatment. At the same time, each sub-tube part 113 formed by cutting is relatively independent and has good deformation performance, thereby enhancing the fit between each sub-tube part 113, being conducive to reducing the overall outer diameter of the multi-cavity part 11, so that the overall outer diameter of the multi-cavity part 11 can be exemplarily less than 3.2 mm, thereby improving the passability in the blood vessel and being able to meet the use requirements of smaller blood vessels.

[0036] In some embodiments, as shown in FIG. 1, the number of the electrode part 13 arranged on each sub-tube part 113 can be multiple, optionally 1-4, and the specific number can be set according to actual use requirements. And the required electrode part 13 is arranged on each sub-tube part 113 in the axial direction of the multi-cavity part 11. In this way, the range of discharge of the electrode part 13 in the axial direction of the multi-cavity part 11 is improved, thereby improving the treatable range. Specifically, the electrode part 13 arranged on the sub-tube part 113 can be sleeved by the end of the distal end of the sub-tube part 113 and moved and adjusted to the set position on the sub-tube part 113, or can be wrapped to form at the set position on the sub-tube part 113.

[0037] Optionally, the shape memory part 12 is arranged in the surrounding cavity 112 of the sub-tube part 113, and one end of the shape memory part 12 is connected with the distal end of the multi-cavity part 11, and the opposite end extends to the proximal end of the multi-cavity part 11 along the surrounding cavity 112. In this way, by connecting one end of the shape memory part 12 with the distal end of the multi-cavity part 11, the position of the shape memory part 12 in the surrounding cavity 112 is fixed, and when the shape is restored, the sub-tube part 113 can be effectively driven to change to the predetermined shape, and the final changed shape is the same as the predetermined shape, which can reliably meet the design requirements.

[0038] In some embodiments, as shown in FIG. 1 and FIG. 4, each electrode piece 13 is connected with an insulated electric lead 14 arranged in the surrounding cavity 112 (refer to FIG. 3), and the electrode piece 13 is supplied with current through the insulated electric lead 14. The effective diameter of the insulated electric lead 14 is exemplarily not less than 0.12 mm, and the overall diameter of the extremely thin multi-layer insulated electric lead is exemplarily not more than 0.25 mm. The insulation breakdown strength of the lead wire is exemplarily up to 5 kV or more, and the multi-layer insulation structure can reduce the risk of electromagnetic interference when corona discharge occurs, and can also reduce the risk of short circuit caused by conduction when the saline is filled. At the same time, the length of the sub-tube part 113 is exemplarily set to 30-80 mm, so that the length of the sub-tube part 113 is within a suitable range, and when bent, it can have a diameter size that meets the use requirements, avoiding too small length to provide effective working area or too long to reduce the overall structural strength.

[0039] In some embodiments, as shown in FIG. 4, the insulated electric lead 14 includes a conductive core 141 and an insulation layer 142. The conductive core 141 is connected with the electrode piece 13, and the insulation layer 142 is arranged in multiple layers. Each insulation layer 142 is sequentially sleeved on the conductive core 141 and extends along the length direction of the conductive core 141. Each insulation layer 142 is coaxially arranged with the conductive core 141. Exemplarily, the conductive core 141 can be composed of a copper core with a diameter of not less than 0.12 mm. The copper wires constituting the copper core can be insulated by being coated with PTFE (polytetrafluoroethylene) or PI (polyimide) to improve the insulation capability of the conductive core 141. In the embodiments of the present application, the insulation layer 142 can be optionally provided with four layers. Under the premise of meeting the overall insulation performance requirements, the overall size of the insulated electric lead 14 can pass through the corresponding surrounding cavity 112 (refer to FIG. 3).

[0040] In some embodiments, during the PFA (Pulse Field Ablation) operation, the intracardiac potential signal needs to be mapped to realize the immediate efficacy evaluation of electrophysiological examination and ablation treatment. The mapping is realized by amplifying and collecting the weak electrocardio signal, and the ablation needs to release high-voltage pulse energy through the electrode. In order to prevent or reduce the situation that the high-voltage pulse damages the detection circuit of the electrocardio signal, the electrode piece 13 is individually led, and the insulation between all electrode pieces 13 can be exemplarily up to 5 kV or more, so as to integrate the mapping and ablation functions together, and realize the multiplexing of the ablation and mapping functions through the rapid switching inside the host.

[0041] In some embodiments, as shown in FIG. 1 and FIG. 3, the multi-lumen member 11 is provided with a braided layer 114 extending from the proximal end towards the direction close to the sub-tube portion 113, and does not extend into the region of the sub-tube portion 113. In some embodiments, in the radial direction, the outer side of each surrounding lumen 112 is provided with the braided layer 114. For example, in the radial direction, for the region of each surrounding lumen 112 on the proximal side of the sub-tube portion 113, the outer side of each surrounding lumen 112 is provided with the braided layer 114.

[0042] By providing the braided layer 114, the torque transmission capacity of the multi-lumen member 11 is improved, so that the whole can be reliably moved in the blood vessel. The braided layer 114 can be a stainless steel braid, which has great strength and also has suitable elastic bending deformation performance. The way of providing the braided layer 114 in the multi-lumen member 11 can be not continuously provided in the circumferential direction, but provided on the outer side of the position where each surrounding lumen 112 is located, and each braided layer 114 is not connected, so that not only the strength of the surrounding lumen 112 can be enhanced, but also the overall structural strength can be improved. In addition, since the distal end of the multi-lumen member 11 needs to be cut to form each sub-tube portion 113, the braided layer does not extend into the region of the sub-tube portion 113, so as not to affect the cutting of the multi-lumen member 11.

[0043] In other embodiments, as shown in FIG. 3, the braided layer 114 can also be circumferentially arranged around the multi-lumen member 11, and each surrounding lumen 112 is located in the region surrounded by the braided layer 114. In this way, in the circumferential direction of the multi-lumen member 11, the same braided layer 114 surrounds the outer side of each sub-tube portion 113, which can simultaneously provide protection for each sub-tube portion 113 to avoid accidental puncture.

[0044] In some embodiments, in order to adjust the hardness of the multi-lumen member 11 as needed, not only can it be achieved by adjusting the material forming the multi-lumen member 11, but also it can be achieved by adjusting the thickness or density of the braided layer, and the arrangement is various.

[0045] In some embodiments, the cross-sectional shape of each surrounding cavity 112 is at least partially the same in a direction perpendicular to the length direction of the multi-cavity member 11, i.e., the cross-sectional shape of each surrounding cavity 112 obtained in the same reference direction is at least partially the same. Since the insulated electric lead 14 needs to be passed out of the surrounding cavity 112, such arrangement does not need to select the surrounding cavity 112 to be passed out of the insulated electric lead 14 due to the different shapes of the surrounding cavity 112, thereby improving the convenience of installation. Moreover, the inner wall surface of the surrounding cavity 112 is arranged as a smooth curved surface, which has small frictional resistance and is conducive to improving the smoothness of the insulated electric lead 14 passing through. At the same time, it is also convenient for the flow of fluid (such as saline). Exemplarily, the inner wall surface of the surrounding cavity 112 arranged as a smooth curved surface can be realized by a machining process or by arranging a PTFE (polytetrafluoroethylene) lining layer. Similarly, the inner wall surface of the central cavity 111 can also be arranged by arranging a PTFE (polytetrafluoroethylene) lining layer to improve the smoothness of the surface.

[0046] In some embodiments, as shown in FIGS. 5 to 7, the electrode member 13 is formed with a receiving hole 131 for inserting the sub-tube part 113 (see FIG. 1), so that the electrode member 13 can be mounted on the sub-tube part 113. Moreover, a voltage equalizing structure 132 is arranged on the discharge side of both ends of the electrode member 13, or a voltage equalizing ring 133 is connected to the discharge side of both ends of the electrode member 13, and the voltage equalizing ring 133 is provided with the voltage equalizing structure 132. Exemplarily, since the voltage required to be borne by the nanosecond self-expanding pulse energizing device 1 is higher, when performing a pulse electric field ablation operation, high-voltage pulse energy is released through the electrode on the catheter. In order to prevent or reduce the sharp discharge or spark discharge when high-voltage pulse discharge, the electric field distribution is designed to be more uniform. In the embodiments of the present application, by arranging the voltage equalizing structure 132 or the voltage equalizing ring 133 provided with the voltage equalizing structure 132 on the discharge side of both ends of the electrode member 13, the voltage equalizing structure 132 is a smooth circular arc surface, and under the action of the voltage equalizing structure 132, the discharge side of both ends of the electrode member 13 no longer has a sharp tip, thereby making the electric field distribution more uniform, so as to avoid or reduce the spark discharge caused by the sharp tip, thereby improving the safety and service life of use.

[0047] In some embodiments, as shown in Figures 1 and 5, at least the cross-sectional shape of the receiving hole 131 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 electrode 13 is attached to the outer wall of the sub-tube 113. In this way, after the electrode 13 is installed on the sub-tube 113, it can fit tightly against the outer surface of the sub-tube 113, which not only reliably achieves discharge but also eliminates local protrusions, thereby facilitating a reduction in the overall radial dimension of the multi-cavity component 11. Furthermore, in this manner, the shape of the outer edge of the cross-section of the electrode 13 can be the same as or different from the shape of the receiving hole 131, and can be configured as needed.

[0048] In some embodiments, the shape of the outer edge of the cross-section of the electrode 13 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.

[0049] In some embodiments, a positioning sensor (not shown in the figure) for positioning is arranged on at least one of the sub-tube portions 113, close to the proximal end of the multi-cavity member 11. In this way, the position of the sub-tube portion 113 can be positioned by the positioning sensor arranged, facilitating accurate treatment. Optionally, the positioning sensor is a magnetic positioning sensor, which has good positioning effect and is safe to use. The self-expanding pulse energizing device 1 provided in the embodiments of the present application is directly machined on the basis of the multi-cavity member 11 without the need for excessive and complex structural design, making the self-expanding pulse energizing device 1 simpler in structure, and the machining and production are realized by cutting, which is relatively simple in production process and has lower requirements, thus well meeting the reproducible requirements of the self-expanding pulse energizing device 1. The shape memory member 12 is arranged to automatically deform the sub-tube portions 113 into a preset shape, which is a clever design. The multi-layer insulation design of the insulated electric lead 14 improves the insulation capacity between the electrode members 13, so that the insulation level of different electrode members 13 can meet the requirements of nanosecond pulse discharge of higher voltage and higher repetition frequency, preventing the generation of corona discharge and interference electric signals. The equalizing structure 132 of the end surface of the electrode member 13 is designed to make the electric field distribution more uniform, effectively preventing or reducing the generation of spark discharge, and greatly reducing the heat generation in the discharge process. The close design of the electrode member 13 and the sub-tube portion 113 effectively reduces the overall outer diameter of the multi-cavity member 11, and improves the overall transportability and passability. Moreover, each electrode member 13 is connected by a separate and mutually insulated insulated electric lead 14, realizing the time division multiplexing of the electrode member 13, so that the same electrode member 13 can be ablated and mapped at different time periods during the PFA operation. A machining method is also provided in the embodiments of the present application for machining the self-expanding pulse energizing device 1 described above, as shown in FIG. 8, which realizes the machining of the multi-cavity member 11 by means of a machining tool 2. The machining tool 2 includes a workbench 21, a tool holder 22 mounted on the workbench 21, a cutting knife 23 mounted on the tool holder 22, a positioning block 24 for positioning the multi-cavity member 11, a positioning seat 25 for abutting against the multi-cavity member 11, and a push rod 26 for pushing the positioning seat 25. The machining method includes:

[0050] As shown in FIGS. 8 and 9, the positioning needle 27 is inserted into the center cavity 111 of the multi-cavity piece 11 to be processed, and the core rod 28 is inserted into each surrounding cavity 112, respectively, to increase the rigidity of the multi-cavity piece 11 during processing to prevent the multi-cavity piece 11 from being deformed during processing. The multi-cavity piece 11 is then placed on the worktable 21 of the processing tool 2, one end of the multi-cavity piece 11 abuts against the positioning seat 25, and the positioning block 24 is pressed against the middle position of the multi-cavity piece 11 to prevent the multi-cavity piece 11 from being warped during cutting. After the position of the multi-cavity piece 11 is positioned, the cutting knife 23 on the processing tool 2 abuts against the part to be cut on the multi-cavity piece 11. Thereafter, the driving force generated by the push rod 26 moves the positioning seat 25, so that the multi-cavity piece 11 moves towards the cutting knife 23, and the cutting knife 23 cuts the multi-cavity piece 11 to form a plurality of sub-pipe portions 113.

[0051] Of course, in other embodiments, the multi-cavity piece 11 can be prevented from moving by abutting the positioning seat 25 against the push rod 26, and then the cutting knife 23 is moved towards the multi-cavity piece 11 to cut to form a plurality of sub-pipe portions 113. After cutting is completed, the positioning block 24 is loosened, the processed multi-cavity piece 11 is removed from the processing tool 2, and the positioning needle 27 and the core rod 28 are extracted, respectively.

[0052] In some embodiments, the part to be cut on the multi-cavity piece 11 to form the sub-pipe portions 113 is provided with a shape memory member 12, and the number of the shape memory members 12 is equal to the number of the sub-pipe portions 113. The shape memory member 12 is provided according to the number of the sub-pipe portions 113, and when the multi-cavity piece 11 is cut, the cutting position of the cutting knife 23 is between two adjacent sub-pipe portions 113, and the number of the cutting knives 23 is equal to the number of the sub-pipe portions 113 to be cut. The angle of the cutting knife 23 relative to the axial direction of the multi-cavity piece 11 is adjusted so that the cutting knife 23 is inclined at a certain angle (exemplarily 30-75 degrees) relative to the axis of the multi-cavity piece 11, thereby reducing the cutting resistance and the wear of the cutting knife 23.

[0053] In other embodiments, the angle of the cutting knife 23 relative to the positioning block 24 can also be adjusted, so that after the cutting knife 23 is installed in the knife holder 22, the cutting knife 23 is always tightly attached to the wall of the knife holder 22 by the lateral force generated by the spring pressure, thereby ensuring the position accuracy of the cutting knife 23.

[0054] In some embodiments, when cutting the multi-cavity piece 11, the cutting knife 23 can be continuously cut from the end of the distal end of the multi-cavity piece 11 to the proximal end to form a plurality of sub-tube portions 113, and the cut length is exemplarily 30mm-80mm. In this way, the distal end of each sub-tube portion 113 is a free end. Then, the electrode piece 13 is sleeved from the end of the sub-tube portion 113, so that each sub-tube portion 113 is sleeved with the electrode piece 13. The insulating electric lead 14 is connected to each electrode piece 13, and the insulating electric lead 14 is arranged in the surrounding cavity 112 of the sub-tube portion 113 where the electrode piece 13 is located, and then extends to the proximal end of the self-expanding pulse energizing device 1 until it can be connected to the high-voltage pulse generator.

[0055] In some embodiments, when cutting the multi-cavity piece 11, the cutting knife 23 can be continuously cut from the end of the distal end of the multi-cavity piece 11 to the proximal end to form a plurality of sub-tube portions 113, and the cut length is exemplarily 30mm-80mm. In this way, the distal end of each sub-tube portion 113 is a free end. Then, the electrode piece 13 is sleeved from the end of the sub-tube portion 113, so that each sub-tube portion 113 is sleeved with the electrode piece 13. The insulating electric lead 14 is connected to each electrode piece 13, and the insulating electric lead 14 is arranged in the surrounding cavity 112 of the sub-tube portion 113 where the electrode piece 13 is located, and then extends to the proximal end of the self-expanding pulse energizing device 1 until it can be connected to the high-voltage pulse generator.

[0056] The above is only a specific embodiment of the present application, but the protection scope of the present application is not limited thereto. Any person skilled in the art can easily think of changes or replacements within the technical range disclosed in the present application, which should be covered in the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A self-inflating pulse-energizing device, wherein, The application relates to a multi-cavity piece, a shape memory piece, and an electrode piece. The multi-cavity piece has a central cavity and a plurality of surrounding cavities surrounding the central cavity, each of the surrounding cavities and the central cavity axially extends and is not communicated with each other, and a part of the multi-cavity piece between an axial proximal end and a distal end is axially cut into a plurality of circumferentially separated sub-tube parts, each of the sub-tube parts has one of the surrounding cavities inside, and each of the sub-tube parts is provided with a through hole communicating with the surrounding cavity inside; The shape memory piece is arranged in each of the sub-tube parts, and the shape memory piece is provided with a predetermined shape, so that each of the sub-tube parts can be self-inflated to outwardly protrude in a curved shape; The electrode piece is sleeved on each of the sub-tube parts, and the electrode piece is used for passing pulse current.

2. The self-inflating pulse-empowering device of claim 1, wherein, The number of the through holes is 2-6.

3. The self-inflating pulse-empowering device of claim 1, wherein, The wall thickness of the multi-cavity piece is greater than a preset value.

4. The self-inflating pulse-empowering device of claim 3, wherein, The preset value is 0.5-1.5 mm.

5. The self-inflating pulse-empowering device of any one of claims 1-4, wherein, The electrode piece is used for passing pulse current when the sub-tube part outwardly protrudes in a curved shape or when the sub-tube part extends in a straight line.

6. The self-inflating pulse-empowering device of any one of claims 1-5, wherein, Each of the shape memory pieces is arranged in the surrounding cavity of the sub-tube part along the length direction of the sub-tube part, and one end of each of the shape memory pieces is connected with the distal end of the multi-cavity piece.

7. The self-inflating pulse-empowering device of any one of claims 1-6, wherein, Each of the electrode pieces is connected with an insulated electric lead wire arranged in the surrounding cavity, and the length of the sub-tube part is 30-80 mm.

8. The self-inflating pulse-empowering device of claim 7, wherein, The insulated electric lead wire comprises a conductive core and an insulation layer, the conductive core is connected with the electrode piece, the insulation layer is arranged in multiple layers, each of the insulation layers is sleeved on the conductive core layer by layer and extends along the length direction of the conductive core, and each of the insulation layers is coaxially arranged with the conductive core.

9. The self-inflating pulse-empowering device of any one of claims 1-8, wherein, A braided layer is arranged in the multi-cavity piece, the braided layer 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.

10. The self-inflating pulse-empowering device of any one of claims 1 or 9, wherein, In the radial direction, the outer side of each of the multi-cavity pieces is provided with the braided layer.

11. The self-inflating pulse-empowering device of any of claims 9-10, wherein, In the radial direction, for the region part of each of the surrounding cavities located on the proximal end side of the sub-tube part, the outer side of each of the surrounding cavities is provided with the braided layer.

12. A self-inflating pulse-empowering device according to any one of claims 9-11, 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.

13. The self-inflating pulse-empowering device of any one of claims 1-12, wherein, In the direction perpendicular to the length direction of the multi-cavity piece, the cross-sectional shapes of each of the surrounding cavities are at least partially the same; wherein the inner wall surface of the surrounding cavity is a smooth curved surface.

14. The self-inflating pulse-empowering device of any of claims 1-13, wherein, The electrode piece is formed with a receiving hole for inserting the sub-tube part; wherein the two end discharge sides of the electrode piece are provided with an equalizing structure; or the two end discharge sides of the electrode piece are connected with an equalizing ring, and the equalizing ring is provided with an equalizing structure.

15. The self-inflating pulse-empowering device of claim 14, 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 electrode piece is attached to the outer wall of the sub-tube part.

16. The self-inflating pulse-empowering device of any of claims 1-13, wherein, In the direction perpendicular to the length direction of the sub-tube part, the cross-sectional outer edge of the electrode piece is the same as the shape of the cross-sectional outer edge of the sub-tube part.

17. The self-inflating pulse-empowering device of any of claims 1-13, wherein, At least one positioning sensor for positioning is arranged in any one of the sub-tube parts, and the positioning sensor is close to the proximal end of the multi-cavity piece.

18. A method of processing for the self-inflating pulse-energized device as claimed in any one of claims 1-17, wherein, The processing method comprises: inserting a positioning needle into a central cavity of a multi-cavity part to be processed, and inserting a core rod into each surrounding cavity; placing and fixing the multi-cavity part on a processing tool, and making a cutting knife on the processing tool abut a part to be cut on the multi-cavity part; driving the cutting knife on the processing tool to cut the multi-cavity part to form a plurality of sub-tube parts; taking the multi-cavity part out of the processing tool, and extracting the positioning needle and the core rod.

19. The method of processing of claim 18, 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.

20. The method of processing of claim 19, wherein, Each of the sub-tube parts is sleeved with the electrode part, and each electrode part is connected with an insulated electric lead wire, and the insulated electric lead wire is arranged in the surrounding cavity of the sub-tube part where the electrode part is located.

21. The method of processing according to claim 19, wherein, The cutting knife continuously cuts from a preset distance from the end of the distal end to the proximal end, and the cutting length is 30-80 mm.

22. The method of processing of claim 21, wherein, Each of the sub-tube parts is wrapped with the electrode part, and each electrode part is connected with an insulated electric lead wire, and the insulated electric lead wire is arranged in the surrounding cavity of the sub-tube part where the electrode part is located.

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