WO2023072205A1

WO2023072205A1 - Electrode wire and fabrication method therefor

Info

Publication number: WO2023072205A1
Application number: PCT/CN2022/127997
Authority: WO
Inventors: 高伟; 杨竹清; 石峰
Original assignee: 深圳市应和脑科学有限公司
Priority date: 2021-10-29
Filing date: 2022-10-27
Publication date: 2023-05-04
Also published as: CN113975625A

Abstract

The present application relates to the field of medical instruments, and discloses an electrode wire and a fabrication method therefor. The electrode wire (20) comprises: at least one segmented electrode (201), at least two isolation rings (203), at least two conductive filaments (206), and a support tube (204); the segmented electrodes (201) are sleeved on the support tube (204) by using the form of being provided between two adjacent isolation rings (203); the segmented electrodes (201) each comprise at least two sub-electrode sheets (202), and the sub-electrode sheets (202) each comprise a body (2022) and first coupling portions that are provided on two opposite axial sides of the body (2022); each of the isolation rings (203) is provided with a positioning portion and a second coupling portion, and each of the sub-electrode sheets (202) may be detachably connected to two adjacent isolation rings (203) by means of the cooperation of the first coupling portions and the second coupling portions; a plurality of circumferentially distributed through grooves (2041) are provided on the support tube (204), wherein some of the through grooves (2041) are used for accommodating the positioning portions of the isolation rings (203), the other through grooves (2041) are used for accommodating the conductive filaments (206), and one conductive filament (206) is accommodated in one through groove (2041); and the distal ends of the conductive filaments (206) are electrically connected to the bodies (2022) of the sub-electrode sheets (202). The electrode wire (20) has a simple assembly process and a stable assembly relationship, and the fabrication method therefor is simple and feasible.

Description

A kind of electrode wire and its manufacturing method

Cross References to Related Applications

This application is based on the Chinese patent application with the application number "202111272424.X" and the filing date is October 29, 2021, and claims the priority of the Chinese patent application. The entire content of the Chinese patent application is incorporated herein by reference. into this application.

technical field

The application belongs to the field of medical devices, in particular to an electrode lead and a manufacturing method thereof.

Background technique

Implantable neurostimulation systems can be used to treat chronic pain, Parkinson's, epilepsy, movement disorders, incontinence, and many other conditions. For example, the deep brain stimulation system (deep brain stimulation, DBS) implants the electrode leads into the specific nucleus area of the human brain, and the pulse generator implanted in the body passes pulses with parameters such as frequency, pulse width and amplitude. The signal stimulates the target, and then has the effect of relieving Parkinson's, dystonia, epilepsy and other diseases. With the continuous development and maturity of this technology, its clinical application has been more and more affirmed.

The traditional DBS electrode wire has multiple ring electrodes at the far end to stimulate the brain target. However, since the stimulation current is evenly distributed around the ring electrodes, it has no directionality and cannot be guided to one or more specific areas around the ring electrodes. location, it is difficult to achieve precise stimulation, and it may also produce some side effects caused by unnecessary stimulation. Therefore, a new DBS electrode wire came into being. The DBS electrode wire is provided with a plurality of segmented electrodes at the far end, and each segmented electrode can stimulate a specific area through control, thereby improving the stimulation accuracy. However, the segmented electrodes need to be circumferentially positioned and reliably fixed on the electrode wires, and the assembly and process are very difficult. Therefore, at present, molds are usually used to realize segmented electrode positioning, and then integral injection molding is performed, which requires high precision of the mold and is difficult to assemble.

Contents of the invention

The technical scheme that this application provides is as follows:

The application provides an electrode lead, including:

at least one segmented electrode, at least two spacer rings, at least two conductive filaments, and a support tube;

The segmented electrode is sleeved on the support tube in the form of being arranged between two adjacent spacer rings, and the segmented electrode includes at least two sub-electrode sheets, and the sub-electrode sheets include a body and a a first coupling portion disposed on axially opposite sides of the body;

The spacer ring is sleeved on the support tube, and is provided with a positioning part and a second coupling part. a detachable connection of the isolating ring;

The support tube is provided with several circumferentially distributed through grooves, wherein part of the through grooves are used to accommodate the positioning parts of the spacer rings, and one of the through grooves accommodates the corresponding positioning parts of all the spacer rings , the other through grooves are used to accommodate the conductive wires, and one of the conductive wires is accommodated in one of the through grooves; the distal end of the conductive wires is electrically connected to the body of the sub-electrode sheet, so The proximal end of the conductive wire is accommodated in the through groove, and extends from the through groove to the proximal end of the electrode wire.

The present application also provides a method for manufacturing an electrode wire, comprising the following steps:

(1) Pre-preparing a segmented electrode including at least two sub-electrode sheets, a spacer ring, a support tube, and a conductive wire, the sub-electrode sheets include a body and first coupling parts arranged on opposite axial sides of the body, so A positioning portion and a second coupling portion are provided on the spacer ring, and the support tube has several circumferentially distributed through grooves;

(2) electrically connecting the body of each of the sub-electrode sheets with one of the conductive wires to obtain a sub-electrode sheet kit;

(3) Put the positioning part corresponding to the spacer ring into the same through groove of the support tube, and then place the spacer ring on the target position of the support tube along the axial direction;

(4) Snap the first coupling part on the sub-electrode sheet assembly obtained in step (2) to the second coupling part of the isolation ring, and connect the sub-electrode obtained in step (2) The conductive wire on the chip set is placed in the through groove;

(5) Repeat step (4) to complete the assembly of all the sub-electrode sheets and the isolation ring of the same segmented electrode;

(6) Repeat step (3), put another spacer ring on the other side of the segmented electrode, and put the corresponding positioning parts of another spacer ring into the same In the through groove, all the sub-electrode sheets of the segmented electrode are assembled with another isolating ring according to step (4), so as to realize the detachable connection between the segmented electrode and the isolating rings on both sides;

(7) Repeat steps (4) to (6) to complete the detachable connection between all the segmented electrodes and the isolation rings on both sides to obtain an assembly;

(8) Filling and curing the assembly with glue to obtain the electrode lead.

(3) Put all the spacer rings into the support tube, and put the corresponding positioning parts of all the spacer rings into the same through groove of the support tube, and then place the all the spacer rings are moved to the target position of the support tube;

(4) Snap the first coupling part on each of the sub-electrode sheet sets obtained in step (2) to the second coupling part of the isolation ring, and connect each of the sub-electrode sheet assemblies obtained in step (2) The conductive wire on the sub-electrode sheet kit is put into the through groove to obtain an assembly, and realize detachable connection of all the segmented electrodes with the isolation rings on both sides;

(5) Filling and curing the assembly with glue to obtain the electrode lead.

An electrode wire provided by the present application and its manufacturing method can bring at least one of the following beneficial effects:

By distributing the segmented electrodes and the spacer rings on the support tube at intervals, it is ensured that spacer rings are provided on both axial sides of each segmented electrode. Wherein, the segmented electrode includes at least two sub-electrode sheets, and first coupling parts are provided on opposite axial sides of each sub-electrode sheet body. The isolation ring is provided with a positioning part and a second coupling part, and the support tube is provided with several circumferentially distributed through grooves, and the corresponding positioning parts of all the isolation rings are placed in the same through groove on the support tube , to ensure that the circumferential direction of all spacer rings on the support tube is consistent. The second coupling part is used for detachable connection with the first coupling part, and the sub-electrode sheet is arranged on the isolation ring through the cooperation of the first coupling part and the second coupling part, so as to realize each sub-electrode sheet of each segmented electrode Positioned on the support tube in the circumferential direction, the sub-electrode sheets can be accurately arranged on the segmented electrodes and reliably fixed on the electrode wires to avoid the problem of falling off during use. The distal end of the conductive wire is electrically connected to the body of the sub-electrode sheet, and its proximal end is accommodated in the through groove and extends to the proximal end of the electrode wire. A through groove on the support tube accommodates a conductive wire, thereby ensuring that the electrode wire The electrical connection of each electrode. In addition, the structure and matching relationship of the sub-electrode sheet, the spacer ring and the support tube make the assembly process of the electrode wire simple and the assembly relationship stable.

Description of drawings

In order to illustrate the technical solutions of the embodiments of the present application more clearly, the drawings that need to be used in the description of the embodiments will be briefly introduced below. Obviously, the drawings in the following description are some embodiments of the present application. Ordinary technicians can also obtain other drawings based on these drawings on the premise of not paying creative work.

Fig. 1 is a schematic diagram of the structure of the distal part of the electrode wire provided by some embodiments of the present application;

Fig. 2 is a schematic structural diagram of a sub-electrode sheet provided by some embodiments of the present application;

3 is a schematic structural view of a sub-electrode sheet kit formed by connecting conductive wires to the sub-electrode sheets provided in some embodiments of the present application;

Fig. 4 is a schematic structural view of a support tube with 7 through grooves provided in some embodiments of the present application;

Fig. 5 is a schematic structural diagram of an isolation ring provided by some embodiments of the present application;

Fig. 6 is a schematic diagram of the assembly of a support tube, an isolation ring and a sub-electrode sheet provided by some embodiments of the present application;

Fig. 7 is an assembly cross-sectional view of electrode wires provided by some embodiments of the present application;

Fig. 8 is a schematic diagram of an assembly provided by some embodiments of the present application;

Fig. 9 is a schematic diagram of the structure of the distal part of the electrode wire after injection molding provided by some embodiments of the present application;

Fig. 10 is a schematic structural view of the distal part of the electrode lead provided in some embodiments of the present application;

Fig. 11 is a schematic structural view of a support tube with 8 through slots provided by some embodiments of the present application;

Fig. 12 is an assembly cross-sectional view of electrode wires provided by some embodiments of the present application;

Fig. 13 is a schematic diagram of an assembly provided by some embodiments of the present application;

Fig. 14 is a schematic diagram of the structure of the distal end of the electrode lead after injection molding provided by some embodiments of the present application.

Detailed ways

The purpose of the embodiment of the present application is to provide an electrode wire and its manufacturing method, so as to solve the DBS electrode wire in the prior art, and its segmented electrodes have difficulty in assembly and complicated process under the requirements of achieving circumferential positioning and reliable fixing. And other issues.

An embodiment of the present application provides an electrode wire, including: at least one segmented electrode, at least two spacer rings, at least two conductive wires, and a support tube; The form between the rings is sleeved on the support tube, and the segmented electrode includes at least two sub-electrode sheets, and the sub-electrode sheets include a body and first couplings arranged on opposite axial sides of the body. part; the spacer ring is sleeved on the support tube, and is provided with a positioning part and a second coupling part, and the sub-electrode sheet is matched with the corresponding part through the cooperation of the first coupling part and the second coupling part. The adjacent two spacer rings are detachably connected; the support tube is provided with several circumferentially distributed through grooves, wherein, part of the through grooves are used to accommodate the positioning part of the spacer ring, and one The through groove accommodates the positioning parts corresponding to all the isolation rings, the other through grooves are used to accommodate the conductive wire, and one of the conductive wires is accommodated in one of the through grooves; The distal end is electrically connected to the body of the sub-electrode sheet, and the proximal end of the conductive wire is accommodated in the through groove, and extends from the through groove to the proximal end of the electrode wire. The corresponding positioning parts of all spacer rings are placed in the same through groove of the support tube, so as to ensure that the circumferential direction arrangement of all spacer rings on the support tube is consistent. The sub-electrode pieces are detachably arranged on the isolation ring through the cooperation of the first coupling part and the second coupling part, so as to realize the circumferential direction positioning of each sub-electrode piece of each segmented electrode on the support tube. In this way, the sub-electrode sheets can be accurately arranged on the segmented electrodes and reliably fixed on the electrode wires, avoiding the problem of falling off during use. The distal end of the conductive wire is electrically connected to the body of the sub-electrode sheet, and its proximal end is accommodated in the through groove and extends to the proximal end of the electrode wire. A through groove on the support tube accommodates a conductive wire, thereby ensuring that the electrode wire The electrical connection of each electrode. In addition, the structure and matching relationship of the sub-electrode sheet, the spacer ring and the support tube make the assembly process of the electrode wire simple and the assembly relationship stable.

This application has no special restrictions on the use of the electrode leads, which can be used as DBS electrode leads or other nerve stimulation devices (such as spinal cord electrical stimulation devices, dorsal root nerve stimulation devices, vagus nerve stimulation devices, sacral nerve stimulation devices), Lead wires for cardiac stimulation devices (pacing devices, cardiac ablation devices).

In order to make the purpose, technical solutions and advantages of some embodiments of the present application clearer, some embodiments of the present application will be described in detail below with reference to the accompanying drawings. In this application, if there is no special description, "distal end" and "distal side" refer to the side of the electrode lead that is relatively far away from the external device connected to the electrode lead. Correspondingly, "proximal end" and "proximal side" refer to the electrode wire The side of the wire that is relatively close to the external device that is electrically connected to the electrode lead.

Referring to FIGS. 1 to 9 , an embodiment of the present application provides an electrode wire 20 , including: at least one segmented electrode 201 , at least two isolation rings 203 , at least two conductive wires 206 and a support tube 204 . Specifically, in this embodiment, the electrode wire 20 includes two segmented electrodes 201, three spacer rings 203 and a support tube 204, and the segmented electrodes 201 and spacer rings 203 are arranged on the support tube 204 in a manner of interval distribution. , and ensure that each segmented electrode 201 is provided with spacer rings 203 on both axial sides. Wherein, each segmented electrode 201 includes three sub-electrode sheets 202, and each sub-electrode sheet 202 includes a body 2022 and first coupling parts arranged on opposite axial sides of the body 2022; correspondingly, each spacer ring 203 is provided with There are three second coupling parts, and the cooperation between the first coupling part and the second coupling part enables the sub-electrode sheet 202 to be detachably connected between two adjacent isolation rings 203 . The support tube 204 is provided with several through grooves 2041 distributed in the circumferential direction. Each spacer ring 203 is also provided with one or more positioning parts, in order to ensure that all the spacer rings 203 are arranged in a specific manner in the circumferential direction of the support tube 204 in the electrode lead, so as to ensure the assembly requirements of the sub-electrode sheet 202, so The corresponding positioning portion of each spacer ring 203 is accommodated in the same through groove 2041 on the support tube 204 . Each sub-electrode piece 202 is correspondingly connected with a conductive wire 206 to form a sub-electrode piece set, so as to realize the electrical connection between the segmented electrode 201 and an external device (such as a pulse generator IPG), as shown in FIG. 3 . The electrical connection can be realized by laser welding or resistance welding. The distal end of the conductive wire 206 is electrically connected to the body 2022 of the sub-electrode sheet 202 , and the proximal end of the conductive wire 206 is accommodated in the through groove 2041 and extends to the proximal end of the electrode lead. Since the conductive wires 206 are relatively thin, each conductive wire 206 is accommodated in a through groove 2041 in order to ensure the later use effect and service life.

Due to the larger surface area of the sub-electrode sheet 202, the better the electrode sensing performance, plus the limitation of the size of the electrode wire 20 electrically connected to the sub-electrode sheet 202, the number of sub-electrode sheets 202 in each segmented electrode 201 will not Many, usually three or four. The number of sub-electrode sheets 202 in each segmented electrode 201 of the electrode wire 20 may be consistent, and the number of sub-electrode sheets 202 in each segmented electrode 201 may also be inconsistent. Those skilled in the art can select appropriate segmented electrodes 201 and corresponding isolation rings 203 in the above embodiments according to specific requirements to meet assembly requirements.

In addition, the material of the sub-electrode sheet 202 may be platinum or its alloy, iridium or its alloy. Preferably, a chemical coating (such as titanium nitride TiN, iridium oxide IrO2) is also provided on the outer surface of the sub-electrode sheet 202 to increase its microscopic surface area and improve the sensing performance of the electrode. Preferably, the first coupling portion of each sub-electrode sheet 202 is made of the same material as the body 2022 , thereby reducing processing difficulty and manufacturing cost.

It can be understood that the present embodiment does not limit the shape and size of the sub-electrode sheets 202 , and those skilled in the art can design according to actual needs. Preferably, the shape and size of each sub-electrode sheet 202 in any segment electrode 201 are consistent. For example, in this embodiment, the three sub-electrode pieces 202 of the segmented electrode 201 have the same shape and size, and are evenly arranged in the circumferential direction. Preferably, the inner surface of the sub-electrode sheet 202 matches the outer surface of the support tube 204 to achieve better fit between the segmented electrodes 201 and the support tube 204 .

Referring to FIG. 2 , the first coupling portion of the sub-electrode sheet 202 may be a stepped structure 2021 , and correspondingly, the second coupling portion is a locking groove 2031 . By embedding the step structure 2021 in the locking groove 2031, the circumferential positioning and fixing of the sub-electrode sheet 202 can be realized, and the sub-electrode sheet 202 can be prevented from falling off during use. Preferably, the surface of the stepped structure 2021 matches the surface of the locking groove 2031 to achieve better engagement between the stepped structure 2021 and the locking groove 2031 . Specifically, the body 2022 of the sub-electrode sheet 202 and the stepped structure 2021 are tile-shaped, and the size of the outer surface of the stepped structure 2021 in the radial direction of the support tube 204 is equal to or slightly smaller than that of the body 2022 of the sub-electrode sheet 202 in the support tube. The size of the outer surface in the radial direction of 204 is so that after the stepped structure 2021 is embedded with the slot 2031, the radial size of the embedded part is consistent with the radial size of the segmented electrode 201, so that the surface of the electrode wire 20 is smooth. slip. On the other hand, the width dimension of the step structure 2021 in the circumferential direction of the support tube 204 is smaller than the width dimension of the body 2022 in the circumferential direction of the support tube 204 to form a holding shoulder 2023, thereby making the step structure 2021 compatible with the card After the slot 2031 is embedded, the sub-electrode sheet 202 will not move axially relative to the spacer ring 203 . Wherein, the stepped structure 2021 can be formed by mechanical cutting, laser etching and other methods. In an alternative embodiment, the first coupling part is a slot, and the second coupling part is a stepped structure. By embedding the step structure and the slot, the sub-electrode sheet 202 can also be fixed and positioned in the circumferential direction. In another alternative embodiment, the first coupling part and the second coupling part may also be in a snap-fit relationship or the like.

In this embodiment, the isolation ring 203 is a hollow structure, as shown in FIG. 5 . Its outer surface is preferably cylindrical, and its outer diameter is consistent with that of the segmented electrode 201 , so that the surface of the electrode wire 20 is smooth. The spacer ring 203 can be formed by injection molding, machining, laser cutting and other methods. The material of the isolation ring 203 can be selected from polymer materials such as polyurethane, Peek, and nylon. The inner surface of the spacer ring 203 is provided with a radially inwardly extending protruding structure 2032 as a positioning portion. In addition, the protruding structure 2032 is disposed between any two adjacent second coupling parts. Wherein, the shape of the raised structure 2032 of the isolation ring 203 needs to match the through groove 2041 of the support tube 204, and the size of the raised structure 2032 is slightly smaller than the size of the channel 2041, so that the raised structure 2032 can be accommodated in the through groove of the support tube 204 2041 and slide, so as to ensure positioning and also realize the adjustment of the axial position of the spacer ring 203 on the support tube 204 . Further, the protruding structure 2032 is located on the bisector of the angle between two adjacent second coupling parts, so that the processing of the isolation ring 203 is easier and more convenient. The number of positioning parts is not particularly limited, and may be one or more. In this embodiment, there is only one protruding structure 2032 , and all the protruding structures 2032 of the isolation ring 203 need to be placed in one through groove 2041 , so that the isolation rings 203 are based on the same circumferential reference. In an alternative embodiment, there are multiple protrusion structures 2032, such as two or three. At this time, the protrusion structures 2032 corresponding to all the isolation rings 203 need to be placed in one through groove 2041 . The circumferential distribution positions of the second coupling parts correspond to the circumferential distribution positions of the sub-electrode pieces 202 in the segment electrodes 201 . However, two adjacent sub-electrode sheets 202 in each segment electrode 201 need to be isolated from each other to achieve insulation. For this reason, the adjacent second coupling parts need to maintain sufficient circumferential spacing. In order to more easily control the gap between the two adjacent sub-electrode sheets 202 , the second coupling portions may be arranged on the isolation ring 203 in a uniform distribution manner. In the case that the shape and size of the sub-electrode sheets 202 are consistent, the above arrangement makes the gap between the two adjacent sub-electrode sheets 202 consistent. In addition, considering the processing flow and the assembly relationship between the various components, the second coupling portion can be arranged on the inner surface of the isolation ring 203 . In another embodiment, the second coupling part can also be arranged in the inner wall of the isolation ring 203, which can further maintain the position of the second coupling part in the radial direction. In this embodiment, the sub-electrode sheets 202 on both axial sides of the spacer ring 203 are arranged in a uniform distribution manner, therefore, the second coupling portions are arranged in a circumferential uniform distribution manner on both axial sides of the spacer ring 203 . In other implementations, the second coupling portions may also be arranged in different distributions on both axial sides of the spacer ring 203 , corresponding to the different circumferential distributions of the sub-electrode pieces 202 in the segment electrodes 201 . Exemplarily, three second coupling parts are respectively provided on both axial sides of the isolation ring 203, and the second coupling parts on one side can be arranged according to the preset distribution method of the sub-electrode sheets 202 of the segment electrodes 201 connected thereto. Evenly distributed on the isolation ring 203, the second coupling part on the other side can ensure that two adjacent sub-electrode sheets 202 are non-uniformly arranged on the spacer ring 203 under the premise of the gap.

On the other hand, the number of the second coupling portion of the isolation ring 203 matches the number of the sub-electrode pieces 202 in the corresponding segment electrode 201, so as to satisfy all the sub-electrodes in the segment electrode 201 adjacent to the isolation ring 203 Positioning and fixation of the sheet 202. In this embodiment, the number of sub-electrode sheets 202 of the two segment electrodes 201 is the same, all of which are three, so the number of second coupling parts on the isolation ring 203 between the two segment electrodes 201 is also three. indivual. Of course, in other embodiments, different numbers of second coupling parts can also be set on both sides of the isolation ring 203, for example, three second coupling parts are set on one side of the isolation ring 203, and four second coupling parts are set on the other side. Two coupling parts, to adapt to the situation that one segment electrode 201 connected by the isolation ring 203 has three sub-electrode sheets 202, and the other segment electrode 201 has four sub-electrode sheets 202, that is, the isolation ring 203 in this embodiment can The assembly requirements of segmented electrodes 201 with different numbers of quantum electrode sheets 202 are met. Continuing to refer to FIG. 5 , in this embodiment, the second coupling part is a clamping groove 2031. Since each segmented electrode 201 includes three sub-electrode sheets 202 uniformly arranged in the circumferential direction, correspondingly, the second coupling parts on both sides of the isolation ring 203 The coupling parts each include three locking grooves 2031 uniformly arranged in the circumferential direction. The locking groove 2031 is disposed on the surface of the inner wall of the isolation ring 203 . Moreover, the locking groove 2031 is provided through the axial direction of the spacer ring 203 , that is, the locking grooves 2031 on both sides of the spacer ring 203 form a whole, which facilitates the processing of the spacer ring 203 . Further, the shape of the locking groove 2031 and the shape of the step structure 2021 are both tile-shaped, so as to achieve better engagement between the locking groove 2031 and the step structure 2021 . The size of the step structure 2021 of the sub-electrode sheet 202 is slightly smaller than the size of the slot 2031, so that the step structure 2021 can be conveniently accommodated in the slot 2031, and the sub-electrode sheet 202 cannot rotate in the circumferential direction, and at the same time, the sub-electrode sheet 202 can be rotated. Circumferential positioning. In addition, the sum of the lengths of the stepped structures 2021 of the opposite sub-electrode sheets 202 on both sides of the spacer ring 203 along the axial direction of the spacer ring 203 is less than the axial length of the slot 2031 passing through the spacer ring 203 along the axial direction of the spacer ring 203, so that the shaft It is electrically insulated between adjacent sub-electrode sheets 202 .

As shown in Figures 6 and 7, the inner diameter of the spacer ring 203 matches the outer diameter of the support tube 204, making it easy to place the spacer ring 203

Sleeve onto the support tube 204. A plurality of spacer rings 203 are assembled on the support tube 204, and the protrusion structures 2032 corresponding to all spacer rings 203 are coupled with the same through-slot 2041 on the support tube 204, so as to ensure that the plurality of spacer rings 203 electrode wires 20 in the circumferential direction based on the same benchmark. In this way, after the inner surface of the sub-electrode sheet 202 is bonded to the outer surface of the support tube 204, the stepped structures 2021 at both ends snap into the corresponding slots 2031 of the spacer ring 203 to realize the positioning and fixing of the sub-electrode sheet 202 in the circumferential direction. In addition, the distance between axially adjacent segmented electrodes 201 can be changed by adjusting the length of the isolation ring 203 to meet different human body differences.

Usually, the support tube 204 can be formed by precision extrusion or injection molding, and its material can be selected from polymer materials such as polyurethane, polyetheretherketone (Peek), and nylon. The outer surface of the support tube 204 is provided with a plurality of circumferentially arranged through-slots 2041 , and each through-slot 2041 is used for accommodating a conducting wire 206 passing alone or for accommodating a spacer ring 203 for circumferential positioning. Therefore, the number of through slots 2041 on the support tube 204 is related to the number of segment electrodes 201 , the number of sub-electrode sheets 202 on each segment electrode 201 and the number of positioning parts. Specifically, the number of through grooves 2041 is at least

Wherein, m is the number of segmented electrodes 201; n _i is the number of sub-electrode sheets 202 in each segmented electrode 201, i=1, . . . , m; p is the number of positioning parts. In addition, the sub-electrode sheet 202 has sufficient circumferential width, so that each through groove 2041 for accommodating the conductive wire 206 electrically connected with the sub-electrode sheet 202 can correspond to a sub-electrode sheet 202, so that the conductive wire 206 Can be accommodated in the corresponding through groove 2041. In this embodiment, referring to Fig. 1, Fig. 4 and Fig. 5, the electrode wire includes two segmented electrodes 201, and each segmented electrode 201 includes three sub-electrode sheets 202, correspondingly there are six conductive wires 206 and sub-electrodes 202 The electrode pieces 202 are electrically connected, and the isolation ring 203 includes a positioning portion, so the number of through slots 2041 is at least seven. That is, one of the through grooves 2041 is used for the circumferential positioning of a spacer ring 203, which acts as a positioning groove; each of the remaining six through grooves 2041 is used to accommodate the conductive wire 206 electrically connected to the sub-electrode sheet 202 . Preferably, the through grooves 2041 on the support tube 204 are arranged in a manner of uniform distribution in the circumferential direction. More preferably, the center of the support tube 204 is provided with a through hole 2042 extending through the entire support tube 204 in the axial direction for accommodating a guide wire. During the surgical implantation process, the rigidity of the electrode lead 20 can be enhanced, which is convenient for doctors to operate. It should be noted that during the operation, the doctor needs to insert the guide wire into the central hole of the electrode lead 20, which can increase the rigidity of the electrode lead 20 and facilitate surgical implantation. The material is generally stainless steel or tungsten; and the conductive wire 206 is The sub-electrode sheet 202 of the segment electrode 201 is electrically connected to conduct electricity and transmit electrical signals, and the material is generally a composite metal material. In order to enable the conductive wire 206 to extend along the axial direction of the electrode lead 20 without unnecessary bending, the circumferential width of the body 2022 is configured such that the connection point between the conductive wire 206 and the body 2022 is connected to the through groove 2041 where the conductive wire 206 is located. The axes have the same circumferential position.

Moreover, the electrode lead 20 also includes a spacer sleeve 205 , which is sheathed on the support tube 204 at the proximal end of the most proximal spacer ring 203 for binding the conductive wire 206 . In this embodiment, as shown in FIG. 8 , the isolation sleeve 205 is a cylindrical sleeve, the outer diameter of which is preferably consistent with the isolation ring 203 , and the inner diameter needs to match the outer diameter of the support tube 204 . The spacer sleeve 205 is sleeved at the proximal end of the support tube 204 compared to the segment electrode 201 and the spacer ring 203, and is used to constrain all the conductive wires 206 electrically connected to the segment electrode 201 in the corresponding positions of the support tube 204. Inside the through groove 2041. In this embodiment, there is no special limitation on the selection of the isolation sleeve 205, for example, the isolation sleeve 205 is made of a heat-shrinkable tube or a polyurethane elastic tube.

Further, the electrode lead 20 also includes a distal end cap 207, which is arranged at the farthest end of the electrode lead 20, and is used for the distal limit of the electrode lead 20, even if the segmented electrode 201, the isolation ring 203, etc. Cannot move far. The distal end cap 207 can be an independent component fixed on the distal end of the electrode lead 20 by means of bonding or the like, or can be integrally formed when the electrode lead 20 is filled with glue. The embodiment of the present application also provides a method for manufacturing an electrode wire 20, referring to Fig. 1, Fig. 6, Fig. 8 and Fig. 9, comprising the following steps:

Step (1) Pre-preparing a segmented electrode 201 including at least two sub-electrode sheets 202, a spacer ring 203, a support tube 204, and a conductive wire 206. The first coupling part, the isolation ring 203 is provided with a positioning part and a second coupling part, and the support tube 204 has several through grooves 2041 distributed in the circumferential direction.

Step (2) Electrically connect the body 2022 of each sub-electrode sheet 202 to a conductive wire 206 to form a sub-electrode sheet set. Among them, the conductive wire 206 is cut into a fixed length according to the design requirements. When the sub-electrode sheet 202 is connected to the conductive wire 206, it needs to be connected with the sub-electrode sheet 202 according to the corresponding through groove 2041 of the conductive wire 206 connected to the sub-electrode sheet 202. To the relative position, determine the specific position of the connection point between the conductive wire 206 and the body 2022 on the inner surface of the body 2022 . With such arrangement, it is convenient for each sub-electrode sheet 202 to be distributed in different positions in the circumferential direction during assembly.

Step (3) Put the positioning portion of the spacer ring 203 into a through groove 2041 on the support tube 204 , and then put the spacer ring 203 onto the target position of the support tube 204 along the axial direction. After setting each positioning portion of the spacer ring 203 in a through groove 2041 , the spacer rings 203 to be inserted later need to set the corresponding positioning portion in the same through groove 2041 .

Step (4) Cooperate the first coupling portion on the sub-electrode sheet assembly obtained in step (2) with the second coupling portion of the isolation ring 203, as shown in Figure 6; place the sub-electrode sheet assembly obtained in step (2) on The conductive wire 206 is put into the through groove 2041. Since the position of the second coupling part in the isolation ring 203 is determined by the position of its corresponding sub-electrode sheet 202 in the segment electrode 201, when the first coupling part of the sub-electrode sheet set is matched with the second coupling part After that, the position of the sub-electrode sheet 202 on the segment electrode 201 can be determined. After the other first coupling part of the sub-electrode sheet 202 is matched with the second coupling part of another isolation ring 203, the sub-electrode is completed. Assembly of sheet 202 in segmented electrode 201 . Similar to the above embodiments, in this embodiment, the first coupling portion is a stepped structure 2021 , and correspondingly, the second coupling portion is a locking groove 2031 . Circumferential positioning is achieved through the engagement between the stepped structure 2021 and the locking groove 2031 .

Step (5) Step (4) is repeated to complete the assembly of all sub-electrode sheets 202 and isolation rings 203 of the same segmented electrode 201 .

Step (6) Repeat step (3), put another isolation ring 203 on the other side of the segmented electrode 201, and put the corresponding positioning parts of the other isolation ring 203 into the same through groove 2041 respectively All sub-electrode pieces 202 of the segmented electrode 201 are assembled with another spacer ring 203 according to step (4), so that the segmented electrode 201 is detachably connected to the spacer rings 203 on both sides.

Step (7) Steps (4) to (6) are repeated to complete the detachable connection of all the segmented electrodes 201 and the isolation rings 203 on both sides to obtain an assembly. Preferably, after completing the detachable connection between all the segmented electrodes 201 and the spacer rings 203 on both sides, the spacer sleeve 205 is sleeved on the proximal end of the most end spacer ring 203 along the axial direction of the support tube 204, as shown in FIG. 8 , The conductive wires 206 and the support tube 204 are covered to constrain the proximal ends of all the conductive wires 206 in the corresponding through slots 2041 of the support tube 204 .

In step (8), the assembly is filled with glue and cured to obtain electrode wires. Specifically, put the assembled assembly into a special mold for injection filling, and the filling material can be polyurethane, epoxy resin, etc. As shown in FIG. 9 , after all the gaps are filled with glue and cured, the segmented electrodes 201 are well bonded and fixed, and are insulated from each other. In addition, the distal end cap 207 of the electrode lead 20 can also be molded in a mold at one time. Referring to FIG. 9, the distal end cap 207, as an independent component, is fixed on the distal end of the electrode lead 20 by bonding or other fixing methods, which may easily cause falling off. risks of.

Among them, step (9) can also be added, and step (9) includes the following steps: there may be glue overflow on the surface of the electrode wire 20 after glue injection and curing, and the surface needs to be ground to remove residual glue, so that the surface is smoother, such as by centerless grinding to fulfill. So far, the manufacture of the electrode lead 20 is completed, as shown in FIG. 1 .

The embodiment of the present application also provides a method for manufacturing the electrode wire 20, including the following steps:

(1) A segmented electrode 201 including at least two sub-electrode sheets 202, a spacer ring 203, a support tube 204, and a conductive wire 206 are prepared in advance. A coupling part, the isolation ring 203 is provided with a positioning part and a second coupling part, and the support tube 204 has several through grooves 2041 distributed in the circumferential direction.

(2) The body 2022 of each sub-electrode sheet 202 is electrically connected to a conductive wire 206 to obtain a sub-electrode sheet set.

(3) Insert all spacer rings 203 into the support tube 204, and put the corresponding positioning parts of all spacer rings 203 into the same through groove 2041 on the support tube 204, and then move all spacer rings 203 to Support tube 204 at the target position. That is, it should be noted that the positioning part (the raised structure 2032 in this embodiment) of each spacer ring 203 will be snapped into the same through groove 2041 of the support tube 204 during assembly, so that all spacer rings 203 can be guaranteed to be positioned in the circumferential direction. based on the same benchmark.

(4) The first coupling portion of each sub-electrode sheet assembly obtained in step (2) is engaged with the second coupling portion of the isolation ring 203, and the conductive wire 206 on each sub-electrode sheet assembly obtained in step (2) is placed into the through groove 2041 to achieve detachable connection of all the segmented electrodes 201 and the isolation rings 203 on both sides to obtain an assembly. Specifically, each conductive wire 206 is located in the set through groove 2041, and each sub-electrode sheet 202 snaps the step structure 2021 on both sides into the slot 2031 of the isolation ring 203 on both sides during assembly, ensuring that the sub-electrode sheet The outer arc surface of 202 is on the same cylindrical surface. Since the slots 2031 of the spacer ring 203 are distributed in the circumferential direction according to the preset arrangement of the sub-electrode pieces 202 on the segmented electrodes 201 , the fixing of the sub-electrode pieces 202 by the spacer ring 203 realizes circumferential positioning.

(5) Filling and curing the assembled body with glue to obtain the electrode wire 20 .

Referring to Fig. 10 to Fig. 14, another embodiment of the present application provides an electrode wire 20'. On the basis of the first embodiment, at least one ring-shaped electrode 208 is sleeved on the support tube 204, and the ring-shaped electrode 208 and the Segmented electrodes 201 are spaced apart by spacer rings 203 . Correspondingly, the distal end of the conductive wire 206 is electrically connected to the ring electrode 208, and the proximal end of the conductive wire 206 is accommodated in the through groove 2041 and extends to the proximal end of the electrode wire 20'. Specifically, in this embodiment, the electrode wire 20' includes two segmented electrodes 201, two annular electrodes 208, three isolation rings 203 and a support tube 204, with the two segmented electrodes 201 in the middle, Two ring-shaped electrodes 208 are arranged separately on both sides and sleeved on the support tube 204, between any two adjacent segment electrodes 201 and the segment electrodes 201, between any two adjacent segment electrodes 201 and the ring Spacer rings 203 are used to space between the shape electrodes 208 .

Because the ring electrodes 208 are added, the number of the conductive wires 206 is correspondingly increased, therefore, the number of the through slots 2041 of the support tube 204 changes. Referring to Figure 12, the number of through grooves 2041 is at least

Among them, m is the number of segmented electrodes 201; n _i is the number of sub-electrode sheets 202 that each segmented electrode 201 has, i=1,...,m; p is the number of positioning parts; q is the number of ring electrodes . In an alternative embodiment, when the electrode located at the proximal end of the electrode lead 20' is a ring electrode 208, the distal end of the conductive wire 206 electrically connected to the ring electrode 208 passes through the through slot where a positioning part of the isolation ring 203 is located. 2041 extends to the proximal end of the electrode wire 20', that is, the conductive wire 206 connected to the most recent ring electrode 208 shares a through groove 2041 with the most recent spacer ring 203, and the number of through grooves 2041 is at least

In this embodiment, as shown in FIG. 11 , the number of through grooves 2041 of the support tube 204 is eight, that is, the conductive wire 206 connected to the ring electrode 208 at the most end and a raised structure 2032 of the spacer ring 203 share one. The through groove 2041 reduces the complexity of the process and reduces the production time and production cost without affecting their respective functions.

It should be noted that in this embodiment, the cooperation between the sub-electrode sheet 202, the support tube 204, the wire 206 and the spacer ring 203 is similar to that of the three in the previous embodiment, the difference is that the electrode A ring electrode 208 is added to the wire 20, and the design and selection of the through groove 2041 for accommodating the conductive wire 206 electrically connected to the ring electrode 208 is relative to the through groove 204 where the conductive wire 206 electrically connected to the segment electrode 201 is located. Slot 2041 is more flexible. This simplifies the difficulty of layout. The similarities with the cooperation relationship among the three in the previous embodiment will not be repeated here.

In addition, in the manufacturing method of the electrode wire 20' in this embodiment, because the ring-shaped electrode 208 is added, the following steps are also included before the assembly is obtained after the axial fixation in step (7), preparing the ring-shaped electrode in advance. Electrode 208, each annular electrode 208 is electrically connected with a conductive wire 206 respectively; Referring to FIG. The conductive wire 206 is placed in the through groove 2041 , and the ring electrode 208 connected with the conductive wire 206 is separated from the segment electrode 201 by the isolation ring 203 . The remaining steps are the same as those provided in Embodiment 1, and the finally obtained electrode wire 20' is shown in Figure 14.

It should also be noted that those skilled in the art can understand that in the various embodiments of the present application, many technical details are provided for readers to better understand the present application. However, even without these technical details and various changes and modifications based on the above embodiments, the technical solution claimed in this application can also be realized. The division of the above embodiments is for the convenience of description, and should not constitute any limitation to the specific implementation of the present application, and the various embodiments can be combined and referenced to each other on the premise of no contradiction.

Claims

An electrode wire (20), including: at least one segmented electrode (201), at least two isolation rings (203), at least two conductive wires (206) and a support tube (204);

The segmented electrode (201) is sleeved on the support tube (204) in the form of being arranged between two adjacent spacer rings (203), and the segmented electrode (201) includes at least two a sub-electrode sheet (202), the sub-electrode sheet (202) includes a body (2022) and first coupling parts arranged on opposite axial sides of the body (2022);

The isolation ring (203) is sleeved on the support tube (204), and is provided with a positioning part and a second coupling part, and the sub-electrode sheet (202) is connected to the second coupling part through the first coupling part. The cooperation of the coupling part realizes detachable connection with two adjacent isolation rings (203);

The support tube (204) is provided with several circumferentially distributed through grooves (2041), wherein part of the through grooves (2041) are used to accommodate the positioning part of the spacer ring (203), and One of the through grooves (2041) accommodates the corresponding positioning parts of all the spacer rings (203), the other of the through grooves (2041) is used to accommodate the conductive wires (206), and one of the conductive wires (206) is accommodated in one of the through grooves (2041); the distal end of the conductive wire (206) is electrically connected to the body (2022) of the sub-electrode sheet (202), and the conductive wire (206) The proximal end of the electrode wire (20) is accommodated in the through groove (2041), and extends from the through groove (2041) to the proximal end of the electrode wire (20).
The electrode wire according to claim 1, wherein the second coupling portion is distributed on the inner surface of the isolation ring (203) or on the inner wall of the isolation ring (203).
The electrode wire according to claim 1 or 2, wherein, the first coupling part is a step structure (2021), the second coupling part is a slot (2031), and the step structure (2021) is used for embedding It is arranged in the clamping groove (2031), so that the sub-electrode sheet (202) is positioned on the isolation ring (203) along the circumferential direction.
The electrode wire according to claim 3, wherein the width dimension of the stepped structure (2021) in the circumferential direction of the support tube (204) is smaller than that of the body (2022) in the support tube (204) The width dimension in the circumferential direction forms a holding shoulder (2023), so that the sub-electrode sheet (202) will not move axially relative to the spacer ring (203).
The electrode lead according to claim 3, wherein the outer surface size of the stepped structure (2021) in the radial direction of the support tube (204) is smaller than that of the body (2022) in the support tube (204) ) Dimensions of the outer surface in the radial direction.
The electrode lead according to claim 3, wherein the clamping groove (2031) is uniformly arranged on the spacer ring (203) in the circumferential direction, and is arranged through the spacer ring (203) along the axial direction.
The electrode wire according to claim 6, wherein, the step structure (2021) of the sub-electrode sheets (202) opposite to each other on both sides of the isolation ring (203) is along the side of the isolation ring (203) The sum of the axial lengths is less than the axial length of the axially penetrating slots (2031) along the axial direction of the spacer ring (203), so that the axially adjacent sub-electrode sheets (202) are electrically connected to each other. insulation.
The electrode lead according to claim 1, wherein the positioning portion is disposed on an angle bisector between two adjacent second coupling portions.
The electrode lead according to claim 1 or 8, wherein the positioning part is a protruding structure (2032) extending radially inward, and the protruding structure (2032) is slidably arranged in the through groove (2041).
The electrode wire according to claim 1, wherein the number of said through grooves (2041) is
Wherein, m is the number of the segmented electrodes (201); n i is the number of the sub-electrode sheets (202) that each of the segmented electrodes (201) has, i=1,..., m; p is The number of positioning parts.
The electrode lead according to claim 1, wherein the axial width of the body (2022) is configured such that the conductive wire (206) is in contact with the body (2022) of the sub-electrode sheet (202) The connection point has the same circumferential position as the axis of the through groove (2041) where the conductive wire (206) is located.
The electrode lead according to claim 1, wherein the electrode lead (20) further comprises an isolation sleeve (205), and the isolation sleeve (205) is at the proximal end of the isolation ring (203) at the most end Sleeved on the support tube (204), used for binding the conductive wire (206) and realizing the axial fixation of the segmented electrode (201) and the spacer ring (203).
The electrode wire according to claim 1, wherein, at least one ring-shaped electrode (208) is sleeved on the support tube (204), and the ring-shaped electrode (208) is connected to the segmented electrode (201) Spaced through the isolation ring (203); the far end of the conductive wire (206) is electrically connected to the ring electrode (208), and the proximal end of the conductive wire (206) is accommodated in the through groove (2041 ), and extend along the through groove (2041) to the proximal end of the electrode wire (20).
The electrode wire according to claim 13, wherein the number of said through grooves (2041) is at least
or,

When the electrode located at the nearest end of the electrode wire (20) is a ring electrode (208), the far end of the conductive wire (206) electrically connected to the ring electrode (208) passes through the isolation ring (203) The through groove (2041) where one of the positioning parts is located extends to the proximal end of the electrode lead (20), then the number of the through grooves (2041) is at least

Wherein, m is the number of the segmented electrodes (201); n is the number of sub-electrode sheets (202) that each segmented electrode (201) has, i=1,..., m; p is the positioning The number of parts; q is the number of the ring electrodes (208).
The electrode lead according to claim 1 or 13, wherein a through hole (2042) is opened at the center of the support tube (204), and the through hole (2042) is used for accommodating a guide wire.
A method of manufacturing an electrode lead, comprising the following steps:

(1) Pre-preparing a segmented electrode (201), an isolation ring (203), a support tube (204) and a conductive wire (206) including at least two sub-electrode sheets (202), and the sub-electrode sheet (202) includes a body (2022) and the first coupling part arranged on the axially opposite sides of the body (2022), the positioning part and the second coupling part are provided on the spacer ring (203), and the support tube (204) has several a circumferentially distributed through groove (2041);

(2) electrically connecting the body (2022) of each of the sub-electrode sheets (202) with one of the conductive wires (206) to obtain a sub-electrode sheet kit;

(3) Put the positioning part corresponding to the spacer ring (203) into the same through groove (2041) on the support tube (204), and then place the spacer ring (204) in the axial direction 203) sleeve to the target position of the support pipe (204);

(4) Snap the first coupling part on the sub-electrode sheet assembly obtained in step (2) to the second coupling part of the isolation ring (203), and connect the obtained sub-electrode sheet assembly in step (2) The conductive wire (206) on the sub-electrode sheet assembly is placed in the through groove (2041);

(5) Repeat step (4) to complete the assembly of all the sub-electrode sheets (202) and the isolation ring (203) of the same segmented electrode (201);

(6) Repeat step (3), put another isolating ring (203) on the other side of the segmented electrode (201), and put the corresponding part of another isolating ring (203) The positioning parts are respectively placed in the same through groove (2041), and all the sub-electrode sheets (202) of the segmented electrode (201) are completed with the other isolating ring (203) according to step (4). Assembling to realize the detachable connection between the segmented electrodes (201) and the isolation rings (203) on both sides;

(7) Repeat steps (4) to (6) to complete the detachable connection between all the segmented electrodes (201) and the isolation rings (203) on both sides to obtain an assembly;

(8) Filling and curing the assembly with glue to obtain the electrode lead (20).
The method for manufacturing an electrode lead according to claim 16, wherein, before the assembly is obtained after the axial fixation in the step (7), the following step is also included: pre-preparing a ring-shaped electrode (208), Each of the annular electrodes (208) is electrically connected to a conductive wire (206);

Put the ring electrode (208) connected with the conductive wire (206) on the support tube (204), and connect the conductive wire (206) electrically connected with the ring electrode (208) placed in the through groove (2041), and the spacer ring (203 )interval.
The method for manufacturing an electrode wire according to claim 16, wherein, in the step (6), after realizing the detachable connection between the segmented electrode (201) and the isolation rings (203) on both sides, It also includes the following steps: sleeve the isolation sleeve (205) on the proximal end of the most proximal isolation ring (203) along the axial direction of the support tube (204), and cover the conductive wire (206) and the a support tube (204), to constrain the proximal ends of all the conductive wires (206) in the corresponding through-slots (2041) of the support tube (204), and/or,

In the step (7), when the assembly is filled with glue, the following step is further included: using a mold to form an anti-loosening head at the far end of the assembly at one time.
The method for manufacturing an electrode wire according to claim 16, further comprising a step of grinding the surface of the electrode wire (20) to remove residual glue after the step (8).
A method of manufacturing an electrode lead, comprising the following steps:

(1) Pre-preparing a segmented electrode (201), an isolation ring (203), a support tube (204) and a conductive wire (206) including at least two sub-electrode sheets (202), and the sub-electrode sheet (202) includes a body (2022) and the first coupling part arranged on the axially opposite sides of the body (2022), the positioning part and the second coupling part are provided on the spacer ring (203), and the support tube (204) has several a circumferentially distributed through groove (204);

(2) electrically connecting the body (2022) of each of the sub-electrode sheets (202) with one of the conductive wires (206) to obtain a sub-electrode sheet kit;

(3) Insert all the spacer rings (203) into the support tube (204), and put the corresponding positioning parts of all the spacer rings (204) into the same positions on the support tube (204). One of the through grooves (2041), and then move all the spacer rings (203) to the target position of the support tube (204) in the axial direction;

(4) snap the first coupling part on each of the sub-electrode sheet sets obtained in step (2) to the second coupling part of the isolation ring (203), and obtain the step (2) The conductive wire (206) on each of the sub-electrode sheet sets is placed in the through groove (2041) to obtain an assembly and realize the isolation of all the segmented electrodes (201) from both sides The ring (203) is detachably connected;

(5) Filling and curing the assembly with glue to obtain the electrode lead (20).
An electrode wire, comprising: at least one segmented electrode (201), at least two spacer rings (203) and a support tube (204);

The segmented electrode (201) is sleeved on the support tube (204) in the form of being arranged between two adjacent isolation rings (203), and the segmented electrode (201) includes at least two a sub-electrode sheet (202), the sub-electrode sheet (202) includes a body (2022) and first coupling parts arranged on opposite axial sides of the body (2022);

The isolation ring (203) is sleeved on the support tube (204), and is provided with a second coupling part, and the sub-electrode sheet (202) passes through the connection between the first coupling part and the second coupling part. Cooperate to realize detachable connection with two adjacent spacer rings (203).
The electrode lead according to claim 21, wherein,

The spacer rings (203) are also provided with a positioning portion, and the positioning portion is used to make the circumferential direction arrangement of all the spacer rings (203) on the support tube (204) consistent.
The electrode lead according to claim 22, wherein,

The electrode wire (20) also includes at least two conductive wires (206);

The support tube (204) is provided with several circumferentially distributed through grooves (2041), wherein part of the through grooves (2041) are used to accommodate the positioning part of the spacer ring (203), and One of the through grooves (2041) accommodates the corresponding positioning parts of all the spacer rings (203), the other of the through grooves (2041) is used to accommodate the conductive wires (206), and one of the conductive wires (206) is accommodated in one of the through grooves (2041); the distal end of the conductive wire (206) is electrically connected to the body (2022) of the sub-electrode sheet (202), and the conductive wire (206) The proximal end of the electrode wire (20) is accommodated in the through groove (2041), and extends from the through groove (2041) to the proximal end of the electrode wire (20).