Pulse energization device and processing method

Abstract

The present application is applicable to the technical field of medical instruments, and provides a pulse energization device, comprising a multi-cavity piece, an insertion piece, 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 electrode piece. The insertion piece is inserted into the multi-cavity piece, and one end of the insertion piece is connected to a distal end, so that under the pulling of the insertion piece, the distal end can move axially to drive the deformation of each sub-tube part. The present application, by arranging the multi-cavity piece and directly processing on the basis of the multi-cavity piece, features a simple structure and a simple processing method, enabling the pulse energization device to be reproducible.

Description

Pulse power device and processing method

[0001] Cross-reference to related applications

[0002] This application is based on Chinese Patent Application No. 202410660905.5, filed on May 27, 2024, and claims priority to the aforementioned Chinese Patent Application, 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 pulse power 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 cardiac 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 present application provides a pulse power device and a processing method, which comprises: a multi-cavity part having a central cavity and a plurality of surrounding cavities surrounding the central cavity inside, each of the surrounding cavities and the central cavity extends axially and is not connected to each other, the wall thickness of the multi-cavity part is greater than a preset value, and the part of the multi-cavity part between the proximal end and the distal end in the axial direction is cut into a plurality of circumferentially separated sub-tube parts in the axial direction, 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, the distal end is movable along the axial direction to drive each of the sub-tube parts to switch between a linearly extending state and a curved state protruding outward, an insertion part is inserted into the central cavity and extends to be connected with the distal end, and an electrode part is sleeved on each of the sub-tube parts for passing pulse current in the state of the sub-tube part protruding outward in a curved shape.

[0006] In some embodiments, the application also provides a processing method for processing the pulse power supply 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 following will briefly introduce the drawings needed to be used in the embodiments. Obviously, the drawings described below are some embodiments of the application, and other drawings can also be obtained by those skilled in the art without creative labor on the basis of these drawings.

[0008] Fig. 1 is a structural schematic diagram of a pulse power supply device provided by an embodiment of the application;

[0009] Fig. 2 is another structural schematic diagram of a pulse power supply device provided by an embodiment of the application;

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

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

[0012] Fig. 5 is a sectional view of an electrode piece provided by an embodiment of the application;

[0013] Fig. 6 is a schematic diagram of an electrode piece provided with a voltage equalizing structure by an embodiment of the application;

[0014] Fig. 7 is a schematic diagram of an electrode piece provided with a voltage equalizing ring by an embodiment of the application;

[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 in which a positioning needle and a core rod are inserted by an embodiment of the application.

[0017] Explanation of reference signs:

[0018] 1, pulse power device; 11, multi-cavity part; 101, proximal end; 102, distal end; 111, central cavity; 112, peripheral cavity; 113, sub-tube part; 114, braided layer; 12, insert; 13, electrode part; 131, accommodating hole; 132, pressure equalizing structure; 133, pressure equalizing ring; 14, insulated electrical lead; 141, conductive core; 142, insulating layer;

[0019] 2, processing tool; 21, workbench; 22, tool holder; 23, cutting knife; 24, positioning block; 25, positioning seat; 26, push rod; 27, positioning needle; 28, core rod. DETAILED DESCRIPTION

[0020] In order to make the purpose, technical scheme and advantages of the present application more clear, the present application is further described in detail below in combination with the drawings and examples. It should be understood that the specific examples described herein are only used to explain the present application, and are not used to limit the present application.

[0021] In the specific embodiments, various specific technical features 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 various specific technical features in the present application are not described again.

[0022] In the following description, the terms "first", "second", "..." are only used to distinguish different objects, and do not mean that there is the same or relationship between the objects. It should be understood that the position description "upper", "lower", "outer", "inner" is the position in the normal use state, and the "left", "right" direction represents the left and right direction shown in the specific corresponding schematic diagram, which can be the left and right direction 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 limitation, the element defined by the sentence "includes one" does not exclude the existence of other identical elements 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 as to make the cell gradually necrosis, and finally realize the purpose of tissue ablation. Because of the different damage thresholds of tissue electrical properties and 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 realized, 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, cryoablation and other 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 when treating atrial fibrillation ablation, PFA has the advantages of short ablation time and protection of treatment area or blood vessel and other tissues.

[0025] When performing PFA ablation of atrial fibrillation, it is necessary to quickly perform circumferential pulmonary vein ablation and ensure that the catheter electrode is in close contact, so the design of PFA catheter is crucial. The existing PFA catheter structure is complex, and the production and processing are difficult, which increases the difficulty of producing PFA catheter. The pulse power device or catheter provided by the embodiments of the present application is generally connected with a control device and a high-voltage pulse generator. One end of the pulse power device is inserted into the blood vessel, and the pulse power device can be moved into the tissue to be treated along the blood vessel by operating the control device (such as an operating handle). After the pulse power device is delivered to the site, the high-voltage pulse generator generates high-voltage and high-frequency pulse voltage to the pulse power device, so as to establish a high-intensity electric field at the tissue to be treated and form a region with high current density. By the action of high-voltage pulse electric field on cells, the cell membrane produces irreversible perforation, so as to make the cell gradually necrosis, and finally realize the purpose of tissue ablation.

[0026] 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 change the permeability of the cell membrane to the extracellular environment. For example, a cell subjected to irreversible electroporation can be observed to form one or more pores in its cell membrane, which remain after the electric field is removed. The term "proximal end" herein refers to the end of the pulse power device close to the operator, or the end connected with the operation; "distal end" refers to the end of the pulse power device inserted into the blood vessel, or the end close to the tissue to be treated.

[0027] As shown in FIGS. 1-3, the pulse energizing device 1 provided by the embodiments of the present application comprises a multi-cavity member 11, an insertion member 12 and an electrode member 13. The multi-cavity member 11 is generally a tubular material with a circular cross-sectional shape, and 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.

[0028] In some other embodiments, the wall thickness of the multi-cavity member 11 is greater than a preset value, for example, 0.5-1.5 mm. The specific wall thickness is appropriate to satisfy the reliable arrangement of the central cavity 111 and the surrounding cavities 112, and not to cause the overall diameter to be too large to be unfavorable for the delivery in the blood vessel.

[0029] In some embodiments, the portion of the multi-cavity member 11 between the proximal end 101 and the distal end 102 is cut into a plurality of sub-tube portions 113 along the axial direction. The plurality of sub-tube portions 113 are arranged in a circumferential direction of the multi-cavity member 11. The length direction of each of the sub-tube portions 113 is arranged along the length direction of the multi-cavity member 11. Each of the sub-tube portions 113 has one of the surrounding cavities 112 inside. The distal end of the multi-cavity member 11 is movable along the axial direction, so that each of the sub-tube portions 113 switches between the two shapes of extending along a straight line and protruding outward in a curved shape. Each of the sub-tube portions 113 has an elastic deformation performance, and can be bent under the action of an external force, and can automatically restore to the initial state or substantially the initial state under the action of the elastic deformation force of the sub-tube portion 113 itself after the disappearance of the external force. Generally, the multi-cavity member 11 is made of a high polymer material meeting the medical use standard, such as Pebax (thermoplastic nylon elastomer) and PA (polyamide) high polymer materials, which has high strength, good anti-fracture and elastic performance. The multi-cavity member 11 can be formed in a structure with different hardnesses at different positions by a gradual transition manner, for example, the hardness gradually decreases from the distal end to the proximal end, so that the distal end has good insertion performance, which is favorable for the guiding movement in the blood vessel, and the hardness gradually decreases close to the proximal end, which is convenient for bending. The hardness of the middle region of the multi-cavity member 11 is moderate, for example, the hardness of the middle region of the multi-cavity member 11 is less than the hardness of the proximal end of the multi-cavity member 11, so as to ensure the overall strength and pushability. Of course, the hardness of the multi-cavity member 11 can be set in other forms according to the use requirements, for example, the hardness of a local position is designed to be greater or lower, and the design flexibility is good.

[0030] In some embodiments, as shown in FIG. 2 and FIG. 3, one end of the insertion member 12 (e.g., the distal end of the insertion member 12) is inserted into the central cavity 111 and extends to the distal end of the multi-cavity member 11, and the opposite end of the insertion member 12 (e.g., the proximal end of the insertion member 12) is connected to the control device or used for the operator to hold. In this way, by pulling the insertion member 12, the force can be transmitted to the distal end of the multi-cavity member 11, so that the distal end of the multi-cavity member 11 can move towards the proximal end of the pulse current device 1, and then the sub-tube portions 113 can protrude outward to form a curved shape. The electrode member 13 is sleeved on each sub-tube portion 113, and is used to pass the pulse current on the pulse current device 1, for example, passing the pulse current when the sub-tube portions 113 protrude outward to form a curved shape or when the sub-tube portions 113 extend along a straight line, so that the ablation treatment of the tissue is performed when the sub-tube portions 113 protrude outward to form a curved shape or when the sub-tube portions 113 extend along a straight line. Therefore, in this state, the electrode member 13 arranged on each sub-tube portion 113 discharges to achieve the treatment purpose.

[0031] In some embodiments, under the high-voltage and high-frequency pulse (e.g., nanosecond pulse or millisecond pulse), the electrode member 13 is easy to generate a certain amount of heat due to the contact resistance with the blood, so that the surface temperature of the electrode member 13 increases to promote the blood coagulation mechanism of the blood around the electrode member 13, and a scab is generated on the surface of the electrode member 13, and the scab further increases the contact resistance between the electrode and the blood, thus forming a vicious cycle. In the embodiments of the present application, a through hole (not shown in the figure) is arranged on each sub-tube portion 113 and communicates with the surrounding cavity 112, and the through hole is arranged adjacent to the electrode member 13. By injecting a fluid (e.g., saline) into each surrounding cavity 112 and then making the injected fluid flow out of the corresponding through hole, the fluid flowing out of the vicinity of the electrode member 13 not only improves the conductivity of the surrounding, but also plays a role in continuously cooling the electrode member 13, thereby achieving the purpose of cooling the electrode member 13 and reducing the risk of scab formation.

[0032] In other embodiments, the number of through holes is 2-6, for example, 4, and the plurality of through holes are distributed along the circumference of the sub-tube portion 113.

[0033] The pulse energizing device 1 provided in the embodiments of the present application is provided with a multi-cavity member 11, an insertion 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. A plurality of sub-tube portions 113 are formed by cutting the multi-cavity member 11 in the axial direction between the proximal end and the distal end of the multi-cavity member 11, and each sub-tube portion 113 has one surrounding cavity 112. The electrode member 13 is arranged in each sub-tube portion 113. The insertion member 12 is inserted into the central cavity 111, and one end of the insertion member 12 is connected to the distal end of the multi-cavity member 11. Thus, the distal end of the multi-cavity member 11 can move in the axial direction of the pulse energizing device 1 under the pulling of the insertion member 12, so as to switch the sub-tube portions 113 between the linearly extending state and the curved state of outward protrusion. In some embodiments, the pulse current is passed through the sub-tube portions 113 in the curved state of outward protrusion or the linearly extending state, so as 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, and the multi-cavity member 11 itself has a simple structure and can meet the use requirements, so that there is no need for other complex structure design, and the pulse energizing device 1 has a simpler structure. The machining and production are realized by cutting, and the production process is relatively simple and has low requirements, and can be reproduced, which meets the reproducible requirements of the pulse energizing device 1.

[0034] In some embodiments, as shown in FIGS. 1 and 2, the number of sub-tube portions 113 formed by cutting the multi-cavity member 11 can be set to be a plurality, which is 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 portion 113 respectively faces different positions in the circumferential direction, so as to discharge and ablate different parts of the tissue at the position in the circumferential direction, without the need for rotation at the same position to meet the treatment requirements of different positions, thereby improving the convenience of treatment and reducing the discomfort of the patient during treatment. Meanwhile, each sub-tube portion 113 formed by cutting is relatively independent and has good deformation performance, thereby enhancing the adhesion of each sub-tube portion 113 to the insertion member 12 and the adhesion between the sub-tube portions 113, which is beneficial to the reduction of the overall outer diameter of the multi-cavity member 11, so that the overall outer diameter of the multi-cavity member 11 can be exemplarily less than 3.2 mm, thereby improving the passability in the blood vessel and meeting the use requirements of smaller blood vessels.

[0035] In some embodiments, as shown in FIG. 1 and FIG. 2, the number of electrode pieces 13 arranged on each sub-tube portion 113 can be multiple, optionally 2-4, and the specific number can be set according to actual use requirements. The electrode pieces 13 are arranged on each sub-tube portion 113 in the axial direction of the multi-cavity piece 11. In this way, the range of discharge of the electrode pieces 13 in the axial direction is improved, and the treatable range is further improved. Exemplarily, the electrode pieces 13 arranged on the sub-tube portion 113 can be sleeved by the end of the distal end of the sub-tube portion 113 and moved to the set position on the sub-tube portion 113, or can be wrapped to form at the set position on the sub-tube portion 113.

[0036] In a possible implementation, as shown in FIG. 1, the insert 12 can be a tube body coaxially arranged with the multi-cavity piece 11, such as an elongated filament structure. One end of the insert 12 is inserted into the central cavity 111 and extends in the direction of the distal end 102 to be connected with the distal end of the multi-cavity piece 11. Exemplarily, the proximal end of the insert 12 is fixedly connected with the distal end of the multi-cavity piece 11. The part of the insert 12 in the central cavity 111 can reciprocate in the central cavity 111 to pull the distal end of the multi-cavity piece 11 to move, so that each sub-tube portion 113 can protrude outward to be curved, or reduce the degree of curvature to be cage-shaped. Under the action of the elastic restoring force of each sub-tube portion 113 itself, each sub-tube portion 113 does not bend and is in a horizontal free state (such as a free state of extending linearly along the length direction of the multi-cavity piece 11). Moreover, the material of the insert 12 can be the same as that of the multi-cavity piece 11, which improves the convenience of manufacturing. In a possible implementation, as shown in FIG. 2, the insert 12 can also be a metal wire such as stainless steel or nickel-titanium. The number of the insert 12 can be set according to use requirements. Exemplarily, the number of the insert 12 is 2-4, which is not limited herein. Exemplarily, the number of the insert 12 shown in FIG. 2 is 3.

[0037] In some embodiments, the length direction of the 2-4 inserts 12 extends along the longitudinal axis direction of the multi-cavity piece 11. The 2-4 inserts 12 are arranged in close contact or at intervals. For example, the 2-4 inserts 12 are arranged side by side in a plane parallel to the longitudinal axis of the multi-cavity piece 11, and the side-by-side arrangement can be arranged in close contact or at intervals; or the 2-4 inserts 12 are arranged at intervals along the circumferential direction of the multi-cavity piece 11; or in the cross-sectional direction of the multi-cavity piece, the 2-4 inserts are located at different cross-sectional positions. For example, when the number of the insert 12 is at least three, the cross section formed by the at least three inserts 12 is perpendicular to the length direction of the multi-cavity piece 11.

[0038] It can be understood that the length direction of the insert 12 extends along the longitudinal axis of the multi-cavity member 11, and not only any part of the length direction of the insert 12 extends along the longitudinal axis of the multi-cavity member 11, but also at least a part of the length direction of the insert 12 extends along the longitudinal axis of the multi-cavity member 11 (for example, the length direction of the part of the insert 12 close to the sub-tube part 113 extends along the longitudinal axis of the multi-cavity member 11), and at least a part of the length direction of the insert 12 can be fixed to other structures (for example, the operating handle) deviating from the central axis of the multi-cavity member 11.

[0039] One end of the wire (i.e., the insert 12) is inserted from the central cavity 111 and extends towards the distal end 102 to be connected to the distal end of the multi-cavity member 11, so that the distal end of the multi-cavity member 11 can be pulled to move, and the sub-tube parts 113 can be switched between the curved or cage-shaped state as needed. In addition, a PTFE (polytetrafluoroethylene) or PI (polyimide) coating can be provided on the surface of the wire made of stainless steel or nickel-titanium to improve the durability of the wire and make the wire have higher safety to meet the requirements of medical use.

[0040] In some embodiments, as shown in FIGS. 1 and 4, each electrode member 13 is connected with an insulating electric lead 14 arranged in the surrounding cavity 112, and the insulating electric lead 14 supplies current to the electrode member 13. The effective diameter of the insulating electric lead 14 is exemplarily not less than 0.12 mm, and the overall diameter of the extremely thin multi-layer insulating electric lead is exemplarily not more than 0.25 mm. The insulation breakdown strength of the wire is exemplarily up to 5 kV or more, and the multi-layer insulation structure reduces the risk of electromagnetic interference during corona discharge and reduces the risk of short circuit when conducting during saline infusion. 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 the sub-tube part 113 has a diameter size that meets the use requirements when curved, avoiding too small length to provide effective working area or too long to reduce the overall structural strength.

[0041] In some embodiments, as shown in FIG. 4, the insulated electric lead 14 comprises a conductive core 141 connected with the electrode member 13 and an insulation layer 142, the insulation layer 142 is provided with multiple layers, each insulation layer 142 is sleeved on the conductive core 141 layer by layer, and each insulation layer 142 extends along the length direction of the conductive core 141. Among them, each insulation layer 142 is coaxially arranged with the conductive core 141. Exemplarily, the conductive core 141 can be composed of a copper core, the diameter is exemplarily not less than 0.12 mm, and the copper fine wires constituting the copper core can be insulated by being provided with a PTFE (polytetrafluoroethylene) or PI (polyimide) coating, so as to improve the insulation capacity of the conductive core 141. In the embodiments of the application, the insulation layer 142 can be provided with four layers, which can make the overall size of the insulated electric lead 14 pass through the corresponding surrounding cavity 112 (refer to FIG. 3) under the premise of meeting the overall insulation performance requirements.

[0042] In some embodiments, during the PFA (Pulse Field Ablation) operation, it is necessary to map the intracardiac potential signal 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 the high-voltage pulse from damaging the detection circuit of the electrocardio signal, the electrode member 13 is separately led in the application, and the insulation between all electrode members 13 can be exemplarily up to 5kV 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.

[0043] In some embodiments, as shown in FIG. 1 and FIG. 3, the multi-cavity member 11 is provided with a braided layer 114, the braided layer 114 extends from the proximal end to the direction close to the sub-pipe part 113, and does not extend into the sub-pipe part 113 area. Among them, in the radial direction, the outer side of each surrounding cavity 112 is provided with a braided layer 114; for example, in the radial direction, for the area part of each surrounding cavity 112 located on the proximal side of the sub-pipe part 113, the outer side of each surrounding cavity 112 is provided with a braided layer 114.

[0044] By setting the braided layer 114, the torque transmission capacity of the multi-cavity member 11 is improved, so that the whole can reliably move 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 multi-cavity member 11 can be set in a manner that the braided layer 114 is not continuously set in the circumferential direction, but is set outside the position where each surrounding cavity 112 is located, and each braided layer 114 is not connected, so that the strength of the surrounding cavity 112 can be enhanced, and the overall structural strength can also be improved. In addition, since the multi-cavity member 11 needs to be cut near the distal end to form each sub-tube portion 113, the braided layer does not extend to the sub-tube portion 113 area, so as not to affect the cutting of the multi-cavity member 11.

[0045] In some other embodiments, as shown in FIG. 3, the braided layer 114 can also be arranged in a circumferential direction of the multi-cavity member 11, and each surrounding cavity 112 is located in the area surrounded by the braided layer 114. In this way, the same braided layer 114 surrounds the outside of each sub-tube portion 113 in the circumferential direction of the multi-cavity member 11, which can simultaneously protect each sub-tube portion 113 from accidental puncture.

[0046] In some embodiments, in order to adjust the hardness of the multi-cavity member 11 as needed, the hardness can be adjusted not only by adjusting the material forming the multi-cavity member 11, but also by adjusting the thickness or density of the braided layer, which has various setting modes.

[0047] In some embodiments, the cross-sectional shape of each surrounding cavity 112 perpendicular to the length direction of the multi-cavity member 11 is at least partially the same, that is, the cross-sectional shape of each surrounding cavity 112 obtained in the same reference direction is at least partially the same. The insulated electric lead 14 is arranged to pass out of the surrounding cavity 112, so that the insulated electric lead 14 does not need to be selectively arranged to pass out of the surrounding cavity 112 due to the different shapes of the surrounding cavity 112, which improves 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 achieved by a machining process, or can be achieved by setting a PTFE (polytetrafluoroethylene) lining layer. Similarly, the inner wall surface of the central cavity 111 can also be arranged by setting a PTFE (polytetrafluoroethylene) lining layer to improve the smoothness of the surface.

[0048] In some embodiments, as shown in FIGS. 5-7, the electrode piece 13 is formed with a receiving hole 131 for inserting the sub-tube portion 113 (see FIG. 1), so that the electrode piece 13 can be mounted on the sub-tube portion 113. In addition, a voltage equalizing structure 132 is arranged at the two ends of the electrode piece 13, or a voltage equalizing ring 133 is connected to the two ends of the electrode piece 13, and the voltage equalizing ring 133 is provided with the voltage equalizing structure 132. For example, the voltage required to be borne by the pulse power supply device 1 is higher, and the high-voltage pulse energy is released through the electrode on the catheter during the pulse electric field ablation operation. In order to prevent the tip of the electrode from discharging or sparking during high-voltage pulse discharge, the electric field distribution is designed to be more uniform. In the embodiments of the present application, the voltage equalizing structure 132 is arranged at the two ends of the electrode piece 13, or the voltage equalizing ring 133 provided with the voltage equalizing structure 132 is arranged, and the voltage equalizing structure 132 is a smooth circular arc surface. Under the action of the voltage equalizing structure 132, the two ends of the electrode piece 13 no longer have a sharp tip, so that the electric field distribution is more uniform, and the electric field does not form a serious electric line distortion point at the two ends of the electrode piece 13, thereby avoiding or reducing the sparking caused by the sharp tip under the high-voltage nanosecond pulse of the electrode piece 13, for example, up to 10 kV, and improving the safety and service life of use.

[0049] In some embodiments, as shown in FIGS. 1 and 5, 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 portion 113 in the direction perpendicular to the length direction of the sub-tube portion 113, and the electrode piece 13 is attached to the outer wall of the sub-tube portion 113. In this way, after the electrode piece 13 is mounted on the sub-tube portion 113, the electrode piece 13 can be closely attached to the outer surface of the sub-tube portion 113, so that reliable discharge can be achieved, and there is no local protruding portion, thereby facilitating the reduction of the overall radial size of the multi-cavity piece 11. In addition, in this way, the shape of the outer edge of the cross section of the electrode piece 13 can be the same as the shape of the receiving hole 131, or can be different, and can be set as needed.

[0050] In some embodiments, the shape of the outer edge of the cross section of the electrode piece 13 is the same as the shape of the outer edge of the cross section of the sub-tube portion 113 in the direction perpendicular to the length direction of the sub-tube portion 113. In this way, the overall cross-sectional shape of the multi-cavity piece 11 obtained in the direction perpendicular to the axial direction is consistent, and is circular, which is good in overall aesthetics and is convenient for delivery in a blood vessel.

[0051] In some embodiments, at least one positioning sensor (not shown in the figure) for positioning is arranged on any one of the sub-tube portions 113, and the positioning sensor is close to the proximal end of the multi-cavity piece 11. In this way, the positioning sensor can be used to position the position of the sub-tube portion 113, so that precise treatment can be achieved. Optionally, the positioning sensor is a magnetic positioning sensor, which has good positioning effect and is safe to use.

[0052] The pulse energizing device 1 provided in the embodiment of the present application is directly machined on the basis of the multi-cavity part 11 by setting the multi-cavity part 11, without the need for other complex structure design, so that the pulse energizing device 1 is simpler in structure, and the machining and production are realized by cutting, the production process is relatively simple, and the requirement is lower, which well meets the reproducible requirement of the pulse energizing device 1. The multi-layer insulation design of the insulated electric lead 14 improves the insulation capacity between the electrode parts 13, so that the insulation level of different electrode parts 13 can meet the nanosecond pulse discharge requirement of higher voltage and higher repetition frequency, and prevents the generation of corona discharge and interference electric signal. The equalization structure 132 design of the end surface of the electrode part 13 makes the electric field distribution more uniform, effectively prevents the generation of spark discharge, and greatly reduces the heat generation in the discharge process. The close-fitting design of the electrode part 13 and the sub-tube part 113 effectively reduces the overall outer diameter of the multi-cavity part 11, and improves the overall transportability and passability. In addition, each electrode part 13 is connected by a separate and mutually insulated insulated electric lead 14, realizing the time division multiplexing of the electrode part 13, so that the same electrode part 13 can be used for ablation and mapping in different time periods during the PFA operation.

[0053] The machining method provided in the embodiment of the present application is used for machining the pulse energizing device 1, as shown in FIG. 8, and the machining method is realized by means of the machining tool 2 for machining the multi-cavity part 11. The machining tool 2 includes a workbench 21, a tool holder 22 installed on the workbench 21, a cutting knife 23 installed on the tool holder 22, a positioning block 24 for positioning the multi-cavity part 11, a positioning seat 25 for abutting against the multi-cavity part 11, and a push rod 26 for pushing the positioning seat 25. The machining method includes:

[0054] As shown in FIGS. 8 and 9, the positioning needle 27 is inserted into the central cavity 111 of the multi-cavity part 11 to be machined, and the core rod 28 is inserted into each surrounding cavity 112, respectively, so as to improve the overall hardness of the multi-cavity part 11 during machining, to prevent deformation during machining. Then, the multi-cavity part 11 is placed on the workbench 21 of the machining tool 2, one end abutting against the positioning seat 25, and the middle position of the multi-cavity part 11 is pressed and positioned by the positioning block 24, to prevent the multi-cavity part 11 from being warped during cutting. After the position of the multi-cavity part 11 is positioned, the cutting knife 23 on the machining tool 2 abuts against the part to be cut on the multi-cavity part 11. Then, the drive force generated by the push rod 26 moves the positioning seat 25, so that the multi-cavity part 11 moves towards the cutting knife 23, and the cutting knife 23 cuts the multi-cavity part 11 to form the plurality of sub-tube parts 113.

[0055] Of course, in other embodiments, the plurality of cavities 11 can be prevented from moving by abutting the push rod 26 against the positioning seat 25, and then the cutting knife 23 is moved towards the plurality of cavities 11 to cut to form the plurality of sub-tube portions 113. After the cutting is completed, the positioning block 24 is loosened, the processed plurality of cavities 11 is taken off from the machining tool 2, and the positioning needle 27 and the core rods 28 are respectively extracted.

[0056] In some embodiments, when the plurality of cavities 11 is cut, the number of cutting knives 23 is equal to the number of sub-tube portions 113 to be cut and formed, and the angle of the cutting knife 23 relative to the axial direction of the plurality of cavities 11 is adjusted so that the cutting knife 23 is inclined at a certain angle relative to the axis of the plurality of cavities 11, thereby reducing the cutting resistance and reducing the wear of the cutting knife 23.

[0057] 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 pressure generated by the spring ensures that there is always a lateral force to tightly attach the cutting knife 23 to the wall of the knife holder 22, thereby ensuring the position accuracy of the cutting knife 23.

[0058] In some embodiments, when the plurality of cavities 11 is cut, the cutting knife 23 can be continuously cut from the distal end of the plurality of cavities 11 to the proximal end to form the 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 13 is sleeved on the end of the sub-tube portion 113, so that each sub-tube portion 113 is sleeved with the electrode 13, and the insulating electric lead 14 is connected to each electrode 13, and the insulating electric lead 14 is arranged in the surrounding cavity 112 of the sub-tube portion 113 where the electrode 13 is located, and then extends towards the proximal end of the plurality of cavities 11 until it can be connected to the high-voltage pulse generator.

[0059] In some embodiments, when cutting the multi-cavity piece 11, the cutting knife 23 can also be continuously cut from a preset distance away from the distal end of the tip to the proximal end to form a plurality of sub-tube portions 113, and the cutting length is 30-80 mm. Exemplarily, in this cutting method, the cutting knife 23 does not start cutting directly from the distal end of the tip, but is spaced apart from the distal end of the tip by a preset distance, which can be between 5-15 mm, to ensure that the distal end of each sub-tube portion 113 formed after cutting is not scattered. Of course, other ranges of preset distances can also be used. After completing the cutting to form each sub-tube portion 113, an electrode piece 13 is wrapped around each sub-tube portion 113, and an insulating electric lead 14 is connected to each electrode piece 13. 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 pulse power device 1 until it can be connected to the high-voltage pulse generator. In one embodiment, after completing the arrangement of the electrode piece 13, one end of the insert piece 12 is arranged in the central cavity 111 of the multi-cavity piece 11 and extends to be fixedly connected to the distal end of each sub-tube portion 113. Thus, the two shapes of the sub-tube portions 113, i.e., linear extension and outward protrusion in a curved shape, can be switched by pulling the insert piece 12.

[0060] In other embodiments, when the cutting method starts from the distal end of the tip of the multi-cavity piece 11, after completing the arrangement of the electrode piece 13 on each sub-tube portion 113, one end of the insert piece 12 is arranged in the central cavity 111 of the multi-cavity piece 11, and then the free end of each sub-tube portion 113 is connected to the distal end of the insert piece 12, thereby completing the manufacturing.

[0061] In other embodiments, when the cutting method starts from the distal end of the tip of the multi-cavity piece 11, after completing the arrangement of the electrode piece 13 on each sub-tube portion 113, one end of the insert piece 12 is arranged in the central cavity 111 of the multi-cavity piece 11, and then the free end of each sub-tube portion 113 is connected to the distal end of the insert piece 12, thereby completing the manufacturing.

[0062] The processing method provided in this embodiment 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. Electrode components 13 and connecting inserts 12 are then provided on each sub-tube section 113, connecting the distal end of the insert 12 to the distal end of the multi-cavity component 11. This completes the production of the pulse energizing device 1. This processing method achieves production through cutting, and the process is relatively simple, with low requirements, and good repeatability, thus well meeting the requirement for reproducible pulse energizing device 1.

[0063] The above description is merely a specific embodiment of this application, but the scope of protection of this application is not limited thereto. Any modifications, equivalent substitutions, and improvements 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 pulse energizing device, wherein, The utility model relates to a kind of multi-cavity piece, insert piece and electrode piece, comprising: Multi-cavity piece, it has center cavity and multiple surrounding cavities around the center cavity inside, each surrounding cavity and the center cavity are axially extended and not interconnected, the part of the multi-cavity piece between the proximal end and the distal end in axial is cut into multiple sub-tube parts separated in circumferential direction, each sub-tube part has a surrounding cavity inside, each sub-tube part is provided with through-hole communicating with the surrounding cavity inside, the distal end of the multi-cavity piece can be moved along the axial direction of the multi-cavity piece, to drive each sub-tube part switches between linearly extending and outwardly protruding in curved shape; Insert piece, one end is inserted into the center cavity, and extends to be connected with the distal end of the multi-cavity piece; Electrode piece, each sub-tube part is sleeved, and the electrode piece is used to pass through pulse current.

2. The pulse power device of claim 1, wherein, The wall thickness of the multi-cavity piece is greater than a preset value.

3. The pulsed power device of claim 2, wherein, The preset value is 0.5mm-1.5mm.

4. The pulsed power device of claim 1, wherein, The electrode piece is used to pass through pulse current when the sub-tube part outwardly protrudes in curved shape or when the sub-tube part linearly extends.

5. The pulsed power device of claim 1, wherein, The insert piece is a wire.

6. The pulsed power device of any one of claims 1-5, wherein, The number of the insert piece is 2-4.

7. The pulsed power device of any one of claims 1-6, wherein, The 2-4 insert pieces 12 are arranged closely or spaced.

8. The pulse power device of claim 1, wherein, Each electrode piece is connected with insulated electric lead arranged in the surrounding cavity, and the length of the sub-tube part is 30mm-80mm.

9. The pulse power device of claim 8, wherein, The insulated electric lead includes conductive core and insulation layer, the conductive core is connected with the electrode piece, the insulation layer is arranged in multiple layers, each insulation layer is sleeved on the conductive core layer by layer, and each insulation layer extends along the length direction of the conductive core;Wherein, each insulation layer is coaxially arranged with the conductive core.

10. The pulse power device of claim 1, wherein, The multi-cavity piece is provided with braided layer, 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 sub-tube part area.

11. The pulsed energization device of claim 1 or 10, wherein, In radial direction, the outer side of each surrounding cavity is provided with the braided layer.

12. The pulsed power device of any of claims 10-11, wherein, In radial direction, for the area part of each surrounding cavity located on the proximal end side of the sub-tube part, the outer side of each surrounding cavity is provided with the braided layer.

13. The pulsed power device of any of claims 10-12, wherein, The braided layer is circumferentially arranged around the multi-cavity piece, and each surrounding cavity is located in the area surrounded by the braided layer.

14. The pulsed energizing device of claim 1, wherein, Perpendicular to the length direction of the multi-cavity piece, the cross-sectional shape of each surrounding cavity is at least partially the same;Wherein, the inner wall surface of the surrounding cavity is smooth curved surface.

15. The pulse power supply device according to any one of claims 1 to 14, wherein The electrode piece is formed with accommodating hole for inserting the sub-tube part; Wherein, the two ends of the electrode piece are provided with equalizing structure on the discharge side;Or the two ends of the electrode piece are connected with equalizing ring, and the equalizing ring is provided with equalizing structure.

16. The pulsed power device of claim 15, wherein, Perpendicular to the length direction of the sub-tube part, at least the cross-sectional shape of the accommodating 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.

17. The pulse power device of any one of claims 1 to 16, wherein, 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.

18. The pulsed power device of any one of claims 1 to 14, wherein, At least one positioning sensor is arranged in each of the sub-tube sections for positioning, and the positioning sensor is arranged close to the proximal end of the multi-cavity member.

19. A machining method for the pulse energizing device as claimed in any one of claims 1 to 18, wherein, The processing method comprises: a positioning needle is inserted into the central cavity of the multi-cavity member to be processed, and a core rod is inserted into each of the surrounding cavities; the multi-cavity member is placed on a processing tool and fixed, and a cutting knife on the processing tool is abutted against the part to be cut on the multi-cavity member; the multi-cavity member or the cutting knife on the processing tool is driven to move, so that the cutting knife cuts the multi-cavity member to form a plurality of sub-tube sections; the multi-cavity member is taken out from the processing tool, and the positioning needle and the core rod are respectively extracted.

20. The method of processing of claim 19, wherein, The cutting knife continuously cuts from the end of the distal end to the proximal end to form a plurality of sub-tube sections, and the cutting length is 30mm-80mm.

21. The method of processing of claim 20, wherein, Each of the sub-tube sections is sleeved with the electrode member, and an insulating electric lead wire is connected to each of the electrode members, and the insulating electric lead wire is arranged in the surrounding cavity of the sub-tube section where the electrode member is arranged.

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

23. The method of processing of claim 22, wherein, Each of the sub-tube sections is sleeved with the electrode member, and an insulating electric lead wire is connected to each of the electrode members, and the insulating electric lead wire is arranged in the surrounding cavity of the sub-tube section where the electrode member is arranged.

24. The method of processing of claim 23, wherein, One end of the insertion member is arranged in the central cavity of the multi-cavity member and is integrated with the distal end.

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