CN113694372B

CN113694372B - Stimulation electrodes

Info

Publication number: CN113694372B
Application number: CN202111015667.5A
Authority: CN
Inventors: 姜传江; 朱为然
Original assignee: Jingyu Medical Technology Suzhou Co ltd
Current assignee: Jingyu Medical Technology Suzhou Co ltd
Priority date: 2021-08-31
Filing date: 2021-08-31
Publication date: 2024-11-22
Anticipated expiration: 2041-08-31
Also published as: CN113694372A

Abstract

The present application provides a stimulation electrode, which includes a flexible conductive soft board, wherein the flexible conductive soft board is divided into a stimulation segment, a connecting segment, and an intermediate segment located between the stimulation segment and the connecting segment, wherein the stimulation segment and the connecting segment are respectively cylindrical structures, and the intermediate segment is a cylindrical structure, a spiral structure, or a flattened wavy structure formed by rolling the flexible conductive soft board; a plurality of stimulation contacts are arranged on the outer surface of the stimulation segment of the flexible conductive soft board, a plurality of connecting contacts are arranged on the outer surface of the connecting segment of the flexible conductive soft board, a plurality of conductive layers extending along the length direction of the flexible conductive soft board are embedded in the flexible conductive soft board, and the connecting contact is electrically connected to at least one stimulation contact through at least one conductive layer.

Description

Stimulating electrode

Technical Field

The application relates to the technical field of stimulating electrodes, in particular to a stimulating electrode.

Background

The stimulating electrode is used for being implanted into a human body and applying electric stimulation to a patient. In the prior art, a segmented annular stimulation ring is adopted as a stimulation electrode, when the patient is electrically stimulated, a stimulation signal can be sent to the periphery in 360 degrees, the nerve nucleus part needing stimulation cannot be accurately found, unnecessary electrical stimulation is possibly received at a disease-free part, excessive treatment of brain parts irrelevant to treatment is possibly caused, and unpredictable other symptoms such as slow action, unsmooth speaking, deglutition function degradation and the like are possibly caused.

The existing another stimulation electrode comprises a stimulation end, a connection end and a middle conduction line part positioned between the stimulation end and the connection end, wherein the stimulation end and the connection end are provided with annular segmented contacts, the middle conduction line part is provided with a spiral metal guide wire, the contacts of the stimulation end and the metal guide wire of the middle conduction line part are connected in a welding mode, and the contacts of the connection end and the metal guide wire of the middle conduction line part are connected in a welding mode.

The connection mode of the contact points of the stimulation electrode and the metal guide wires is high in manufacturing cost, the manufacturing process is complex, and when more stimulation contact points are required to be arranged, more metal guide wires for conducting connection are required to be arranged at the moment, the mode is limited by the micro pipe diameter of the stimulation electrode and the size requirement of the metal guide wires, more stimulation contact points are difficult or impossible to arrange (such as 18 stimulation contact points and 24 stimulation contact points), and the screening of a doctor on disease positions and the theoretical research and treatment flexibility of more stimulation contact point positions are limited.

Disclosure of Invention

The application aims to provide a stimulation electrode, which solves the problem of limitation of the pipe diameter size of the existing stimulation electrode on the number of contacts, simplifies the connection mode between the contacts of a stimulation end and the contacts of a connection end, fully utilizes the self structure of a flexible conductive soft board, and has rich and flexible circuit arrangement mode and wide application range when the flexible conductive soft board is used for manufacturing the stimulation electrode.

The application adopts the following technical scheme:

The stimulation electrode comprises a flexible conductive soft board, wherein the flexible conductive soft board is divided into a stimulation section, a connection section and a middle section positioned between the stimulation section and the connection section, the stimulation section and the connection section are respectively in a cylindrical structure, and the middle section is in a cylindrical structure, a spiral structure or a flattened wavy flexible conductive soft board which is formed by rolling; the outer surface of the stimulation section of the flexible conductive soft board is provided with a plurality of stimulation contacts, the outer surface of the connection section of the flexible conductive soft board is provided with a plurality of connection contacts, a plurality of conductive layers extending along the length direction of the flexible conductive soft board are embedded in the flexible conductive soft board, and the connection contacts are electrically connected with at least one stimulation contact through at least one conductive layer.

Preferably, the stimulation contacts are one or more of annular, linear, punctiform or sheet-shaped, the annular stimulation contacts are distributed along the circumferential direction on the outer surface of the stimulation section, and the linear stimulation contacts are distributed along the circumferential direction or along the length direction of the flexible conductive soft board on the outer surface of the stimulation section.

Preferably, the plurality of stimulation contacts are divided into a plurality of groups along the length direction of the flexible conductive soft board, and each group of stimulation contacts comprises three sheet-shaped stimulation contacts which are distributed on the outer surface of the stimulation section at equal intervals along the circumferential direction.

Preferably, the plurality of stimulation contacts comprise two annular stimulation contacts and a plurality of sheet-shaped stimulation contacts positioned between the two annular stimulation contacts, the plurality of sheet-shaped stimulation contacts are divided into a plurality of groups along the length direction of the flexible conductive soft board, and each group of stimulation contacts comprises three sheet-shaped stimulation contacts which are distributed on the outer surface of the stimulation section at equal intervals along the circumferential direction.

Preferably, one of said connection contacts is electrically connected to one of the stimulation contacts via one of the conductive layers.

Preferably, the spacing between adjacent two stimulation contacts along the length of the flexible conductive flexible board is 0.5mm,1mm or 1.5mm.

Preferably, the connection contacts are annular, the annular connection contacts are circumferentially distributed on the outer surface of the connection section, and a plurality of connection contacts are distributed at intervals.

Preferably, the plurality of conductive layers are distributed on at least two layers of the flexible conductive flexible board having different thicknesses in a thickness direction of the flexible conductive flexible board, and at least a portion of the at least two conductive layers overlap in the thickness direction of the flexible conductive flexible board.

Preferably, the stimulating electrode further comprises: the lining pipe is arranged in the stimulation section, the middle section and the connecting section of the flexible conductive soft board; a first support tube disposed within the lined tube proximate the stimulation section to increase the rigidity of the stimulation section of the stimulation electrode and/or a second support tube disposed within the lined tube proximate the connection section to increase the rigidity of the connection section of the stimulation electrode; the outer sleeve is arranged outside the middle section of the flexible conductive soft board and is close to the flexible conductive soft board; the locking ring is fixedly sleeved on the outer sleeve corresponding to the middle section and is adjacent to the connecting section of the stimulating electrode.

Preferably, the first support tube extends from one end of the lining tube near the stimulation section, and the extending part of the first support tube is provided with a smooth end surface.

Compared with the prior art, the application has the technical effects that at least:

Through burying a plurality of conducting layers inside the flexible conductive soft board, the connection contact passes through at least one conducting layer electric connection at least one stimulation contact, when making the flexible conductive soft board into stimulating electrode, owing to need not to walk the line in stimulating electrode's the tiny pipe diameter, can set up more conducting layers and contacts on the stimulating electrode, the circuit arrangement mode is richer and nimble, application scope is wide.

Drawings

The application will be further described with reference to the drawings and examples.

Fig. 1 is a schematic structural view of a flexible conductive flexible board according to an embodiment of the present application;

Fig. 2A is a schematic circuit diagram of a flexible conductive flexible board according to an embodiment of the present application;

FIG. 2B is a schematic view of a partial structure of the flexible conductive flexible board of FIG. 2A adjacent to the stimulation section;

FIG. 2C is a schematic view of a partial structure of adjacent connection sections of the flexible conductive flexible board in FIG. 2A;

FIG. 3 is a cross-sectional view at A-A in FIG. 2B;

FIG. 4 is a cross-sectional view at B-B in FIG. 2C;

Fig. 5 is a schematic structural diagram of a stimulation electrode according to an embodiment of the present application, in which the outer sleeve is omitted;

FIG. 6 is a cross-sectional view at C-C in FIG. 5;

FIG. 7 is a cross-sectional view at D-D in FIG. 5;

FIG. 8A is a schematic view of a partial structure of a stimulating electrode adjacent to a stimulating segment according to an embodiment of the present application;

FIG. 8B is a schematic view of the stimulating electrode of FIG. 8A with the outer sleeve omitted;

FIG. 9 is a partial cross-sectional view of the stimulation electrode of FIG. 8A;

FIG. 10 is a schematic view of a partial structure of adjacent connection sections of a stimulating electrode according to an embodiment of the present application;

FIG. 11 is a partial cross-sectional view of the stimulation electrode of FIG. 10;

Fig. 12 is a schematic flow chart of a method for manufacturing a flexible conductive flexible board according to an embodiment of the present application;

FIG. 13 is a schematic flow chart of forming a conductive layer pattern according to an embodiment of the present application;

fig. 14 is a schematic flow chart of forming a conductive layer according to an embodiment of the present application;

fig. 15 is a flow chart of a method for manufacturing a stimulating electrode according to an embodiment of the present application;

fig. 16 is a schematic structural view of a coiled flexible conductive flexible board adjacent to a stimulation section according to an embodiment of the present application;

FIG. 17 is a flow chart of another method for manufacturing a stimulating electrode according to an embodiment of the present application;

Fig. 18A to 18D are schematic diagrams illustrating a substep of rounding a flexible conductive flexible board according to an embodiment of the present application;

FIG. 19 is a flow chart of a method for fabricating a stimulation electrode according to an embodiment of the present application;

Fig. 20 is a schematic structural diagram of a rounding device according to an embodiment of the present application;

fig. 21 is a schematic structural diagram of a rolling device according to an embodiment of the present application when a lower pressing head is omitted;

fig. 22 is an enlarged schematic view of the structure at S in fig. 21.

In the figure: 10. a flexible conductive flexible board; 10a, a stimulation section; 10b, an intermediate section; 10c, a connecting section; 11. a flexible substrate; 12. a first conductive layer; 12a, a first opening; 121. a first conductor; 13. a second conductive layer; 14. a third conductive layer; 14a, a second opening; 141. a second conductor; 15. a stimulation contact; 16. a connection contact; 17. a direction indication mark; 18. a first insulating layer; 19. a second insulating layer; 20. an inner liner tube; 21. a locking ring; 22. a first support tube; 23. a second support tube; 24. an outer sleeve; 30. a base; 31. a first semicircular groove; 32. a core rod; 40. a lower pressure head; 50. a first lifting assembly; 51. a first bracket; 511. a first lifting guide rail; 52. a first lifting driving mechanism; 521. a first connector; 522. the first lifting screw rod; 53. a second bracket; 531. a first fixing member; 532. a second fixing member; 533. a first sidewall; 534. a second sidewall; 535. a third sidewall; 536. a bottom wall; 537. a second lifting guide rail; 54. an adjustment assembly; 541. an adjusting handle; 542. a slider; 60. a second lifting driving mechanism; 61. a second connector; 62. and a second lifting screw.

Detailed Description

The present application will be further described with reference to the accompanying drawings and detailed description, wherein it is to be understood that, on the premise of no conflict, the following embodiments or technical features may be arbitrarily combined to form new embodiments.

Words of expression position and direction, such as "upper" and "lower", in the present application are described by taking the drawings as examples, but may be changed according to the need, and all the changes are included in the protection scope of the present application. The drawings of the present application are only for illustrating the relative positional relationship, and the layer thicknesses of some portions are shown exaggerated in the drawing for easy understanding, and the layer thicknesses in the drawings do not represent the proportional relationship of the actual layer thicknesses.

Referring to fig. 1 to 4, an embodiment of the present application provides a flexible conductive flexible printed circuit board 10, wherein the flexible conductive flexible printed circuit board 10 is divided into a stimulating section 10a, a connecting section 10c and a middle section 10b between the stimulating section 10a and the connecting section 10c along a length direction, the flexible conductive flexible printed circuit board 10 may be a flattened structure before manufacturing a stimulating electrode, and the flexible conductive flexible printed circuit board 10 may be rounded when manufacturing the stimulating electrode, wherein the stimulating section 10a and the connecting section 10c are respectively processed into a cylindrical structure, and the middle section 10b is processed into a cylindrical structure, a spiral structure or a structure formed by rounding a corrugated flexible conductive flexible printed circuit board.

The flexible conductive flexible board 10 includes: the flexible substrate 11, the plurality of conductive layers and the insulating layer may further include a plurality of first conductive bodies 121, a plurality of second conductive bodies 141, a plurality of stimulating contacts 15, a plurality of connecting contacts 16, a plurality of first conductive shielding layers (not shown), a plurality of second conductive shielding layers (not shown), and a direction indication mark 17. The plurality of conductive layers are buried inside the flexible conductive flexible board 10 and extend along the length direction of the flexible conductive flexible board 10, and the plurality of conductive layers may include a plurality of first conductive layers 12, a plurality of second conductive layers 13, and a plurality of third conductive layers 14.

In some embodiments, the total length of the flexible conductive flexible board 10 may be 300mm, 400mm, 500mm or 600mm, the width of the stimulating segment 10a and the connecting segment 10c may be equal, and the width of the stimulating segment 10a and the connecting segment 10c may be 3mm, 3.2mm, 3.444mm, 3.6mm or 4mm.

The length of the stimulating segment 10a may be 10mm, 12.05mm or 20mm, the length of the intermediate segment 10b may be 300mm, 361.5mm or 400mm, and the length of the connecting segment 10c may be 20mm, 23.2mm or 30mm.

In some embodiments, the thickness of the flexible substrate 11 may be 20 μm, 25 μm or 30 μm, wherein the flexible substrate 11 may be made of polyimide, polyethylene terephthalate or other polymer materials.

In some embodiments, the middle section 10b of the flexible conductive flexible board 10 may have a wave-shaped structure. After the intermediate section 10b of the wave-shaped structure is rounded, the intermediate section 10b can be uniformly coated outside the lining tube 20 and has elasticity when the lining tube 20 is inserted, and the intermediate section 10b of the spiral structure also has elasticity. The middle section 10b of the flexible conductive flexible board 10 is equally wide everywhere in the wave extension direction and may be 1.6mm, 1.8mm or 2mm in width. The width of the middle section 10b of the flexible conductive flexible board 10 in the direction perpendicular to the length direction of the flexible conductive flexible board 10 may be 4.5mm, 4.8mm, 5.079mm, or 5.2mm.

Referring to fig. 3 and 4, the first conductive layer 12 is disposed on the flexible substrate 11 and is located at the stimulating section 10a, the first conductive layer 12 is used for electrically connecting with a stimulating contact 15 on the flexible conductive flexible board 10, the second conductive layer 13 is disposed on the flexible substrate 11 and is located at the middle section 10b, the third conductive layer 14 is disposed on the flexible substrate 11 and is located at the connecting section 10c, the third conductive layer 14 is used for electrically connecting with a connecting contact 16 on the flexible conductive flexible board 10, and the first conductive layer 12, the second conductive layer 13 and the third conductive layer 14 respectively extend along the length direction of the flexible conductive flexible board 10. Each of the second conductive layers 13 is electrically connected to at least one of the first conductive layers 12 and at least one of the third conductive layers 14, such that one connection contact 16 may be electrically connected to one of the stimulation contacts 15 or simultaneously electrically connected to a plurality of the stimulation contacts 15 through the first conductive layer 12 to the third conductive layer 14, or a plurality of the connection contacts 16 may be electrically connected to one of the stimulation contacts 15 or simultaneously electrically connected to a plurality of the stimulation contacts 15 through the first conductive layer 12 to the third conductive layer 14.

In some embodiments, the plurality of conductive layers may be distributed on at least two layers of the flexible conductive flexible board 10 having different thicknesses in the thickness direction of the flexible conductive flexible board 10, at least a portion of the at least two conductive layers overlap in the thickness direction of the flexible conductive flexible board 10, and the number of conductive layers may be increased without changing the width of the flexible substrate 11.

It should be noted that, in the thickness direction of the flexible substrate 11, the plurality of first conductive layers 12 may be located on the same layer or different layers, the plurality of second conductive layers 13 may be located on the same layer or different layers, the plurality of third conductive layers 14 may be located on the same layer or different layers, the manufacturing process may be simplified and the manufacturing difficulty may be reduced when the conductive layers are located on the same layer, and when the conductive layers are located on different layers, the number of conductive layers may be increased under the condition that the width of the flexible substrate 11 is unchanged, so that the number of the stimulating contacts 15 may be increased. In some embodiments, each of the second conductive layers 13 may be electrically connected to one of the first conductive layers 12 and one of the third conductive layers 14, and each of the second conductive layers 13 is integrally formed with the connected one of the first conductive layers 12 and one of the third conductive layers 14. In this way, a connection contact 16 may be electrically connected to a stimulation contact 15 through a first conductive layer 12, a second conductive layer 13 and a third conductive layer 14, and the integrally formed structure may be implemented by disposing the second conductive layer 13 and the first conductive layer 12 and the third conductive layer 14 connected thereto in the same layer in the thickness direction of the flexible substrate 11, which may simplify the manufacturing process and reduce the manufacturing difficulty.

In some embodiments, the thickness of the first conductive layer 12 may be equal to the thickness of the second conductive layer 13, the third conductive layer 14, and the thicknesses may be 0.01mm, 0.02mm, or 0.03mm.

The insulating layer is disposed on the flexible substrate 11 and covers the first conductive layer 12, the second conductive layer 13 and the third conductive layer 14, a portion of the insulating layer located at the stimulation section 10a is provided with a plurality of first openings 12a, for example blind holes, one of the first conductive layers 12 is exposed through one of the first openings 12a, electrical connection between the first conductive layer 12 and one of the stimulation contacts 15 on the flexible conductive flexible board 10 is achieved through one of the first openings 12a, a plurality of second openings 14a are disposed at a portion of the insulating layer located at the connection section 10c, for example blind holes, one of the third conductive layers 14 is exposed through one of the second openings 14a, and electrical connection between the third conductive layer 14 and one of the connection contacts 16 on the flexible conductive flexible board 10 is achieved through one of the second openings 14 a.

In some embodiments, the insulating layer may be selected from parylene or other silicon-based materials.

Through setting up a plurality of first conducting layers 12, a plurality of second conducting layers 13 and a plurality of third conducting layers 14 on flexible substrate 11, wherein every second conducting layer 13 electric connection at least one first conducting layer 12 and at least one third conducting layer 14, with first conducting layer 12 to third conducting layer 14 integrated setting on flexible substrate 11, when making flexible conductive flexible board 10 into stimulating electrode, because need not to walk the line in stimulating electrode's the tiny pipe diameter, can set up more conducting layers and contact on the stimulating electrode, the circuit arrangement mode is richer and nimble, application scope is wide.

In some embodiments, the flexible conductive flexible board 10 may further include a plurality of first conductors 121 and a plurality of second conductors 141, where each of the first openings 12a is provided with one first conductor 121, the first conductors 121 may electrically connect the first conductive layer 12 to one stimulation contact 15 on the flexible conductive flexible board 10, each of the second openings 14a is provided with one second conductor 141, and the second conductors 141 may electrically connect the third conductive layer 14 to one connection contact 16 on the flexible conductive flexible board 10.

In some embodiments, the flexible conductive flexible board 10 may further include a plurality of stimulation contacts 15 and a plurality of connection contacts 16 on the insulating layer, the plurality of stimulation contacts 15 are located on an outer surface of the stimulation section 10a of the flexible conductive flexible board 10 and are spaced apart, the stimulation contacts 15 may be used to apply electrical stimulation, the plurality of connection contacts 16 are located on an outer surface of the connection section 10c of the flexible conductive flexible board 10 and are spaced apart, the connection contacts 16 may establish electrical connection between the stimulation contacts 15 and a stimulator (not shown), the connection contacts 16 may be electrically connected to the stimulator (not shown) through cables, for example, each stimulation contact 15 is connected to at least one first electrical conductor 121, each connection contact 16 is connected to at least one second electrical conductor 141, such that the stimulation contacts 15 establish electrical connection with the stimulation contacts 15 through the first electrical conductor 121, the first electrical conductor layer 12 to the third electrical conductor 14, and the second electrical conductor 141.

In some embodiments, the stimulation contacts 15 may be one or more of annular, linear, dot-shaped or sheet-shaped, the annular stimulation contacts 15 may be circumferentially distributed on the outer surface of the stimulation section 10a, the linear stimulation contacts 15 may be circumferentially distributed on the outer surface of the stimulation section 10a or distributed along the length direction of the flexible conductive flexible board 10, the dot-shaped stimulation contacts 15 may be a dot-shaped structure, and the sheet-shaped stimulation contacts 15 may be a circular sheet-shaped structure or an oval sheet-shaped structure.

In some embodiments, the plurality of stimulation contacts 15 may be divided into a plurality of groups along the length direction of the flexible conductive flexible board 10, and each group of stimulation contacts 15 may include three sheet-like stimulation contacts 15 distributed at equal intervals along the circumferential direction on the outer surface of the stimulation section 10 a.

In some embodiments, the plurality of stimulation contacts 15 may include two annular stimulation contacts 15 and a plurality of sheet-shaped stimulation contacts 15 located between the two annular stimulation contacts 15, the plurality of sheet-shaped stimulation contacts 15 may be divided into a plurality of groups along the length direction of the flexible conductive flexible board 10, and each group of stimulation contacts 15 may include three sheet-shaped stimulation contacts 15 distributed at equal intervals along the circumferential direction on the outer surface of the stimulation section 10 a.

In some embodiments, the plurality of stimulation contacts 15 may be divided into 3 groups along the length direction of the flexible conductive flexible board 10, and after the flexible conductive flexible board 10 is manufactured into the stimulation electrode by arranging the segmented stimulation contacts 15, each group of stimulation contacts 15 can realize independent directional electrical stimulation, so that the generated electrical stimulation can perform electrical stimulation to a specific position/direction, thereby reducing excessive treatment.

Referring to fig. 2A and 2B, in some embodiments, the plurality of stimulating contacts 15 may be distributed in a matrix manner, the plurality of connecting contacts 16 may be distributed at intervals along the length direction of the flexible conductive flexible board 10, each connecting contact 16 may extend along a direction perpendicular to the length direction of the flexible conductive flexible board 10, and the connecting contacts 16 may have a ring-shaped structure.

In some embodiments, the number of stimulation contacts 15 and connection contacts 16 may each be 12. The stimulation contacts 15 may be arranged in 4 columns along the length direction of the flexible conductive flexible board 10 and may be arranged in 3 rows along the width direction of the flexible conductive flexible board 10.

In some embodiments, the number of connection contacts 16 may be 6, wherein 1 connection contact 16 may be electrically connected to 2 stimulation contacts 15 at the same time.

In some embodiments, the width of the annular connection contact 16 may be 0.8mm, 1mm, or 1.5mm. The length of the sheet-like stimulation contacts 15 may be 1.2mm, 1.5mm or 1.8mm and the width of the stimulation contacts 15 may be 0.7mm, 0.9mm or 1.2mm.

The gap between two adjacent connection contacts 16 along the length direction of the flexible conductive flexible board 10 may be 0.3mm, 0.5mm or 0.8mm. The gap between two adjacent stimulation contacts 15 in the same row along the length direction of the flexible conductive flexible board 10 may be 0.5mm, 1mm or 1.5mm.

In some embodiments, the thickness of the stimulation contacts 15 may be equal to the thickness of the connection contacts 16, which may each be 0.03mm, 0.05mm, or 0.08mm.

In some embodiments, the flexible conductive flexible sheet 10 may further include a plurality of first conductive shields and a plurality of second conductive shields on the insulating layer, each of the first conductive shields covering one of the stimulation contacts 15 and each of the second conductive shields covering one of the connection contacts 16. By arranging the first conductive shielding layer and the second conductive shielding layer, the stimulation contact 15 and the connection contact 16 can be prevented from being in direct contact with human tissues, and safety is improved.

In some embodiments, the material of the first conductive protection layer and the second conductive protection layer may be platinum, and the first conductive protection layer and the second conductive protection layer made of platinum have high compatibility and safety with human tissues. The thickness of the first conductive shield layer and the second conductive shield layer may each be 1 μm, 5 μm, or 10 μm.

The flexible conductive flexible board 10 can be manufactured as a stimulating electrode implanted into the human body, and the stimulating contact 15 can be prevented from being exposed to the human body by providing the first conductive shielding layer covering the stimulating contact 15 and the second conductive shielding layer covering the connecting contact 16, so that the safety is high.

With continued reference to fig. 3 and 4, in some embodiments, the flexible substrate 11 has opposing first and second surfaces, each of which may be provided with a plurality of first conductive layers 12, a plurality of second conductive layers 13, and a plurality of third conductive layers 14.

The insulating layers may include a first insulating layer 18 and a second insulating layer 19, the first insulating layer 18 being disposed on and covering the first conductive layer 12, the second conductive layer 13, and the third conductive layer 14 on the first surface of the flexible substrate 11, the second insulating layer 19 being disposed on and covering the first conductive layer 12, the second conductive layer 13, and the third conductive layer 14 on the second surface of the flexible substrate 11, the first opening 12a extending from the first surface to the second surface of the flexible substrate 11 and exposing one of the first conductive layers 12, and the second opening 14a extending from the first surface to the second surface of the flexible substrate 11 and exposing one of the third conductive layers 14. By providing conductive layers on both the first and second surfaces of the flexible substrate 11, the number of conductive layers can be increased without changing the width of the flexible substrate 11, and thus the number of stimulation contacts 15 can be increased.

In some embodiments, the first surface of the flexible substrate 11 may be provided with 6 first conductive layers 12, 6 second conductive layers 13, and 6 third conductive layers 14, and the second surface of the flexible substrate 11 may be provided with 6 first conductive layers 12, 6 second conductive layers 13, and 6 third conductive layers 14.

In some embodiments, each stimulation contact 15 may be electrically connected to the first conductive layer 12 by being connected to one of the first electrical conductors 121; each connection contact 16 may be electrically connected to the third conductive layer 14 by being connected to one of the second conductive bodies 141.

In some embodiments, the stimulation section 10a of the flexible conductive flexible board 10 may further be provided with a direction indication mark 17. The length of the direction indicator 17 may be 2mm, 3mm or 5mm. The direction indicator 17 assists the physician in determining the placement and rotation direction of the stimulation electrode when it is implanted in the body.

Referring to fig. 5 to 11, the embodiment of the present application further provides a stimulation electrode including any of the flexible conductive flexible sheets 10 described above, which may further include a lining tube 20, an outer sleeve 24, a locking ring 21, and a first support tube 22 and/or a second support tube 23.

The stimulating section 10a and the connecting section 10c of the flexible conductive flexible board 10 are respectively processed into a cylindrical structure, the middle section 10b of the flexible conductive flexible board 10 is processed into a cylindrical structure, a spiral structure or a structure formed by rolling the corrugated flexible conductive flexible board 10, and the first opening 12a and the second opening 14a of the insulating layer face the outer surface of the flexible conductive flexible board 10.

The stimulation electrodes may be used to implant a region of the brain to electrically stimulate the patient, and the number of stimulation contacts 15 may be preset as much as possible, such as 8 contacts, 12 contacts or 24 contacts, for optimal stimulation direction and point location combinations, for which the number of first conductive layer 12, second conductive layer 13 and third conductive layer 14 for each stimulation contact 15 is preset.

Compared with the existing stimulation electrode adopting a segmented annular stimulation ring and the stimulation electrode adopting a metal guide wire to connect a stimulation end and a connection end in a welding mode, referring to fig. 2A and 2B, the application designs a segmented stimulation contact mode by using the flexible conductive soft board 10 as a circuit part of the stimulation electrode, and divides the stimulation contacts 15 into a plurality of groups, wherein each group of stimulation contacts 15 can realize independent directional electric stimulation, so that the generated electric stimulation can perform electric stimulation aiming at a specific position/direction, thereby reducing excessive treatment; the stretching requirement of the stimulation electrode lead is met based on the process, the middle section 10b of the flexible conductive soft board 10 is designed to be of a wave-shaped structure, and the arrangement of 12 connecting lines corresponding to 12 stimulation contacts (3 x4 matrix) is achieved based on the compact structural characteristics of the flexible conductive soft board 10.

In some embodiments, the overall length of the stimulation electrode may be 300mm, 400mm, 500mm, or 600mm, and the outer diameter of the stimulation electrode may be 1.05mm, 1.25mm, or 1.5mm.

In some embodiments, the outer diameter of the stimulation electrode may be 1.25mm±0.02mm and the cylindricity of the stimulation electrode may be 0.01mm.

Referring to fig. 6 to 11, in some embodiments, the liner tube 20 may be disposed within the stimulation section 10a, the middle section 10b, and the connection section 10c of the flexible conductive flexible sheet 10. The liner tube 20 may be made of a material that is insensitive to thermal deformation, such as polyurethane. The outer diameter of the liner tube 20 may be 1.1mm and the inner diameter may be 0.9mm. By providing the lining tube 20, the rigidity of the stimulation electrode can be increased, facilitating the implantation operation when implanting the stimulation electrode.

In some embodiments, the first support tube 22 may be disposed in the lining tube 20 near the stimulating section 10a to increase the rigidity of the stimulating section 10a of the stimulating electrode, the second support tube 23 may be disposed in the lining tube 20 near the connecting section 10c to increase the rigidity of the connecting section 10c of the stimulating electrode, the first support tube 22 may be made of polypropylene, the second support tube 23 may be made of stainless steel, the first support tube 22 and the lining tube 20 may be adhesively fixed, the second support tube 23 and the lining tube 20 may be adhesively fixed, in particular, a small amount of glue may be applied to the inner wall of the lining tube 20 when the first support tube 22 and the second support tube 23 are inserted, or a small amount of glue may be applied to the outer surfaces of the first support tube 22 and the second support tube 23, and the adhesive fixation is realized after insertion. When the stimulating electrode is implanted, the stimulating section 10a and the connecting section 10c bear larger pressure, the rigidity of the stimulating section 10a and the connecting section 10c of the stimulating electrode is increased through the first supporting tube 22 and the second supporting tube 23, the operation efficiency during implantation is improved, and a doctor can conveniently complete the implantation operation.

Referring to fig. 9, the interior of the first support tube 22 may be filled with structural glue, which may be UV glue or epoxy. The model of the structural glue is for example MED2000. After the structural glue is filled and formed, the first support tube 22 may extend from an end of the lining tube 20 near the stimulation section 10a, where the extending portion of the first support tube 22 has a rounded end surface, for example, a hemispherical convex head. By providing the protruding portion of the first support tube 22 with a rounded end surface, damage to human tissue can be reduced when the stimulating electrode is implanted.

The outer diameter of the first support tube 22 may be 0.9mm and the inner diameter may be 0.52mm; the outer diameter of the second support tube 23 may be 0.9mm and the inner diameter may be 0.8mm.

In some embodiments, the outer sleeve 24 may be disposed outside the stimulating section 10a, the middle section 10b, and the connecting section 10c of the flexible conductive flexible board 10 and proximate to the flexible conductive flexible board 10, a third opening may be disposed on the outer sleeve 24 corresponding to the first opening 12a of the insulating layer, and a fourth opening may be disposed on the outer sleeve 24 corresponding to the second opening 14a of the insulating layer. A third opening of the outer sleeve 24 may be used for setting the stimulation contact 15 and a fourth opening of the outer sleeve 24 may be used for setting the connection contact 16. The outer sleeve 24 may be polyurethane, the outer diameter of the outer sleeve 24 may be 1.25mm, and the inner diameter may be 1.17mm. By providing the outer sleeve 24, the flexible conductive flexible board 10 can be separated from human tissues, and adverse effects of body fluid on the performance of the flexible conductive flexible board 10 and adverse effects of the flexible conductive flexible board 10 on human tissues can be reduced.

In some embodiments, the outer sleeve 24 may be disposed only outside the middle section 10b of the flexible conductive flexible sheet 10 and proximate to the flexible conductive flexible sheet 10. For the stimulating section 10a and the connecting section 10c of the flexible conductive soft board 10 which are not covered by the outer sleeve 24, after the stimulating contact 15 and the connecting contact 16 are manufactured, insulating materials or other protective materials can be filled between the stimulating contact 15 and between the connecting contacts 16, so that the outer surfaces of the stimulating section 10a and the connecting section 10c of the flexible conductive soft board 10 are flush with the outer surface of the outer sleeve 24, the stimulating electrode is in an integral structure, the outer surface of the stimulating electrode is smooth and has no bulge, and the damage to human tissues can be reduced during implantation.

Referring to fig. 5, in some embodiments, the locking ring 21 may be fixedly sleeved on the outer sleeve 24 corresponding to the middle section 10b and adjacent to the connection section 10c of the stimulating electrode, the length of the locking ring 21 may be 2.5mm, and the distance between the locking ring 21 and the end surface of the connection section 10c may be 23.2mm, for example. The locking ring 21 may be a metal ring, a PTFE (polydimethylsiloxane) coating may be disposed on the locking ring 21, the binding force between the locking ring 21 and the stimulating electrode preferably satisfies that 14N is drawn and not loosened, when the stimulating electrode is electrically connected with a stimulator (not shown) through a cable, the connecting section 10c of the stimulating electrode needs to be fixedly connected with one end of the cable, by disposing the locking ring 21, after the connecting section 10c of the stimulating electrode is inserted into a connecting piece at one end of the cable, the connecting section 10c of the stimulating electrode can be abutted against the locking ring 21 through a fastener, so that the connecting section 10c of the stimulating electrode is fixedly connected with one end of the cable.

Referring to fig. 12, the embodiment of the present application further provides a method for manufacturing a flexible conductive flexible board 10, where the flexible conductive flexible board 10 is divided into a stimulating section 10a, a connecting section 10c and an intermediate section 10b located between the stimulating section 10a and the connecting section 10c along the length direction, and the method for manufacturing the flexible conductive flexible board 10 includes steps S11 to S13.

Step S11: a plurality of first conductive layers 12, a plurality of second conductive layers 13, and a plurality of third conductive layers 14 are patterned on the flexible substrate 11.

Referring to fig. 13, in some embodiments, the step S11 may include: step S111 to step S112.

Step S111: a dry film is formed on the surface of the flexible substrate 11. The dry film may be formed on the surface of the flexible substrate 11 by hot rolling, and the temperature of the hot rolling may be 110 ℃.

Step S112: and exposing and developing the dry film on the flexible substrate 11 by using a mask plate, and forming patterns of a plurality of first conductive layers 12, a plurality of second conductive layers 13 and a plurality of third conductive layers 14 on the flexible substrate 11.

The dry film may be a polymerizable resin that reacts with ultraviolet rays, and the dry film may be polymerized to form a stable substance attached to the flexible substrate 11 after irradiation of ultraviolet rays, thereby achieving plating and etching blocking functions. The mask plate can be a film, and the part with the image on the mask plate can not transmit ultraviolet rays due to the use of the mask plate, so that the part which is not irradiated by the ultraviolet rays on the dry film can not generate polymerization. The dry film part which is not polymerized can be removed by using the developing solution, and the circuit which needs to be reserved is displayed, so that the circuit pattern manufactured through the step has the characteristics of thin, straight and flat. The developer may be a weak base, for example sodium carbonate or sodium bicarbonate solution.

Step S12: a plurality of first conductive layers 12, a plurality of second conductive layers 13 and a plurality of third conductive layers 14 are formed on the flexible substrate 11, the first conductive layers 12 are disposed on the flexible substrate 11 and located at the stimulating section 10a, the second conductive layers 13 are disposed on the flexible substrate 11 and located at the intermediate section 10b, and the third conductive layers 14 are disposed on the flexible substrate 11 and located at the connecting section 10c, and each of the second conductive layers 13 is electrically connected to at least one of the first conductive layers 12 and at least one of the third conductive layers 14.

Referring to fig. 14, in some embodiments, the step S12 may include: step S121 to step S123.

Step S121: magnetron sputtering or vacuum evaporation is performed on the surface of the flexible substrate 11, a plurality of first metal layers are formed on the patterns of the plurality of first conductive layers 12 of the flexible substrate 11, a plurality of second metal layers are formed on the patterns of the plurality of second conductive layers 13, and a plurality of third metal layers are formed on the patterns of the plurality of third conductive layers 14.

The method for performing magnetron sputtering or vacuum evaporation on the surface of the flexible substrate 11 may include: sequentially performing ultrasonic cleaning, hot air drying and surface plasma treatment on a dry film on the surface of the flexible substrate 11; the flattened flexible substrate 11 is placed in a sputtering jig or an evaporation jig, and magnetron sputtering or vacuum evaporation is performed. After the magnetron sputtering and the vacuum evaporation are completed, the thicknesses of the first metal layer, the second metal layer and the third metal layer can be 200nm, 600nm or 1 μm.

Step S122: and removing the dry film. The method of removing the dry film may include: washing the dry film by using sodium hydroxide solution; the surface of the flexible substrate 11 is rinsed with water.

Step S123: and thickening the first metal layers, the second metal layers and the third metal layers by adopting an electroplating mode to obtain a plurality of first conductive layers 12, a plurality of second conductive layers 13 and a plurality of third conductive layers 14. Since the dry film is removed without a metal layer, the conductive layer cannot be formed at the position where the dry film is removed during electroplating.

The method for thickening the first metal layers, the second metal layers and the third metal layers by electroplating can comprise the following steps: cleaning the surface of the flexible substrate 11 with an alkaline cleaner; placing the flattened flexible substrate 11 in an electroplating liquid for electroplating; rinsing with water; and (5) drying. The current used in the plating may be 2mA.

After the electroplating is completed, the thickened first metal layer forms the first conductive layer 12, the thickened second metal layer forms the second conductive layer 13, the thickened third metal layer forms the third conductive layer 14, and the thicknesses of the first conductive layer 12, the second conductive layer 13 and the third conductive layer 14 may be 0.1 μm, 10 μm, 50 μm or 100 μm.

Step S13: an insulating layer is formed on the flexible substrate 11, the insulating layer is disposed on the flexible substrate 11 and covers the first conductive layer 12, the second conductive layer 13 and the third conductive layer 14, a plurality of first openings 12a are disposed at a portion of the insulating layer located at the stimulating section 10a, one of the first conductive layers 12 is exposed through one of the first openings 12a, a plurality of second openings 14a are disposed at a portion of the insulating layer located at the connecting section 10c, and one of the third conductive layers 14 is exposed through one of the second openings 14 a.

The flexible substrate 11 has opposite first and second surfaces, and the processing steps of hot roll forming a dry film, exposing, developing, magnetron sputtering or vacuum evaporation, removing the dry film, and plating may be performed on the first and second surfaces of the flexible substrate 11, respectively.

In some embodiments, the method for manufacturing the flexible conductive flexible board 10 may further include: a first conductor 121 is formed in each of the first openings 12a, and a second conductor 141 is formed in each of the second openings 14 a. The formation of the first conductor 121 and the second conductor 141 may be performed after the flexible conductive flexible board 10 is rounded when the stimulation electrode is manufactured, and the formation of the first conductor 121 and the second conductor 141 may be performed by 3D curved surface sputtering.

In some embodiments, the method for manufacturing the flexible conductive flexible board 10 may further include: a plurality of stimulating contacts 15 and a plurality of connecting contacts 16 are formed on the insulating layer, the stimulating contacts 15 are located at the stimulating section 10a of the flexible conductive flexible board 10 and are distributed at intervals, the connecting contacts 16 are located at the connecting section 10c of the flexible conductive flexible board 10 and are distributed at intervals, each stimulating contact 15 is respectively connected with at least one first conductor 121, and each connecting contact 16 is respectively connected with at least one second conductor 141. The stimulating contact 15 and the connecting contact 16 may be completed by 3D curved sputtering, the forming of the first electrical conductor 121 and the second electrical conductor 141 may be performed in the same step as the forming of the stimulating contact 15 and the connecting contact 16, and the surfaces of the stimulating contact 15 and the connecting contact 16 formed are flush with the outer surface of the insulating layer.

In some embodiments, the flexible substrate 11 has opposing first and second surfaces, and a plurality of first conductive layers 12, a plurality of second conductive layers 13, and a plurality of third conductive layers 14 are formed on both the first and second surfaces of the flexible substrate 11.

The step S13 may include: a first insulating layer 18 is formed on the first surface of the flexible substrate 11, a second insulating layer 19 is formed on the second surface of the flexible substrate 11, the first insulating layer 18 covers the first conductive layer 12, the second conductive layer 13 and the third conductive layer 14 on the first surface of the flexible substrate 11, the second insulating layer 19 covers the first conductive layer 12, the second conductive layer 13 and the third conductive layer 14 on the second surface of the flexible substrate 11, the first opening 12a extends from the first surface to the second surface of the flexible substrate 11 and exposes one of the first conductive layers 12, and the second opening 14a extends from the first surface to the second surface of the flexible substrate 11 and exposes one of the third conductive layers 14.

Wherein a first insulating layer 18 is formed on a first surface of the flexible substrate 11, and a method of forming a second insulating layer 19 on a second surface of the flexible substrate 11 may include: a first insulating layer 18 is formed on the first surface of the flexible substrate 11 and a second insulating layer 19 is formed on the second surface of the flexible substrate 11 using a vacuum vapor deposition process or a coating process.

In some embodiments, the method for manufacturing the flexible conductive flexible printed circuit 10 may further include, before step S11, roughening the surface of the flexible substrate 11, where the bonding force between the flexible substrate 11 and the conductive layer can be improved by the roughening.

Wherein, the roughening treatment method for the surface of the flexible substrate 11 may include any one of the following: surface plasma treatment; or pressing copper plates with copper buds on the first surface and the second surface of the flexible substrate 11 respectively, so that the first surface and the second surface of the flexible substrate 11 respectively form pits in the shape of copper buds. The width of the copper bud may be 2 μm.

Referring to fig. 15, the embodiment of the present application further provides a method for manufacturing a stimulation electrode, where the stimulation electrode includes any one of the flexible conductive flexible boards 10, and the method for manufacturing a stimulation electrode includes step S20.

Step S20: the stimulating section 10a and the connecting section 10c of the flexible conductive flexible board 10 are respectively manufactured into a cylindrical structure, the middle section 10b of the flexible conductive flexible board 10 is manufactured into a cylindrical structure, a spiral structure or a structure formed by rolling the corrugated flexible conductive flexible board 10, and the first opening 12a and the second opening 14a of the insulating layer face the outer surface of the flexible conductive flexible board 10.

After the rolling, a part of the structure of the flexible conductive flexible board 10 is shown in fig. 16.

Referring to fig. 17, in some embodiments, the stimulation electrode may further include a liner tube 20, and the step S20 may include steps S201 to S203.

Step S201: the flattened flexible conductive flexible sheet 10 is placed on the base 30 of a rounding device. Wherein, the first surface of the flexible conductive flexible board 10 is attached to the upper surface of the base 30.

Step S202: the inner lining pipe 20 with the core rod 32 inserted therein is used to press a part of the flexible conductive flexible board 10 into the first semicircular groove 31 on the upper surface of the base 30, the lower pressing head 40 with a second semicircular groove on the front end surface is aligned to the inner lining pipe 20, the circular groove formed by abutting the second semicircular groove with the first semicircular groove 31 is matched with the shape of the flexible conductive flexible board 10 after being rolled, the part of the flexible conductive flexible board 10 which is not pressed into the second semicircular groove is pressed into the second semicircular groove, so that the stimulating section 10a and the connecting section 10c of the flexible conductive flexible board 10 are respectively manufactured into a cylindrical structure, a spiral structure or a wavy flexible conductive flexible board 10 after being rolled into a structure, and the inner lining pipe 20 is left in the stimulating section 10a, the middle section 10b and the connecting section 10c of the flexible conductive flexible board 10. Wherein, the outer diameter of the lining pipe 20 is matched with the inner diameter of the flexible conductive soft board 10 after being rolled.

Step S203: the mandrel 32 inside the liner tube 20 is removed.

Referring to fig. 18A-18D and 19, in some embodiments, the step S20 may include steps S301-S303.

Step S301: the flattened flexible conductive flexible printed circuit board 10 is placed on a first semicircular groove 31 extending in a first direction of an upper surface of a base 30 of a rounding apparatus, the first semicircular groove 31 being semicircular in cross-sectional shape perpendicular to the first direction.

Step S302: a portion of the flexible conductive flexible sheet 10 is pressed into the first semicircular groove 31 using a core rod 32, the core rod 32 being disposed above the first semicircular groove 31 of the base and extending in a first direction.

Step S303: the rest of the flexible conductive soft board 10 is pressed and attached to the core rod 32 by using the lower pressing head 40, a second semicircular groove extending along the first direction is arranged on the lower surface of the lower pressing head 40, the cross section of the second semicircular groove along the direction perpendicular to the first direction is semicircular, after the upper surface of the base 30 and the lower surface of the lower pressing head 40 are close to each other, a round hole extending along the first direction formed by the first semicircular groove 31 and the second semicircular groove is matched with the shape of the flexible conductive soft board 10 after being rolled.

In some embodiments, the step S302 may include: the core rod 32 is sleeved with the lining pipe 20, a part of the flexible conductive soft board 10 is pressed into the first semicircular groove 31 by using the core rod 32 and the lining pipe 20, and the outer diameter of the lining pipe 20 is matched with the inner diameter of the flexible conductive soft board 10 after being rolled.

Referring to fig. 20-22, in some embodiments, the rounding apparatus includes a base 30, a mandrel 32, and a lower ram 40, and may further include a first lift assembly 50 and a second lift drive mechanism 60.

Referring to fig. 21, the upper surface of the base 30 is provided with a first semicircular groove 31 extending in a first direction, and the first semicircular groove 31 has a semicircular cross-sectional shape perpendicular to the first direction.

The core rod 32 is disposed above the first semicircular groove 31 of the base 30 and extends in a first direction, and the core rod 32 is used to press a portion of the flattened flexible conductive flexible board 10 into the first semicircular groove 31. The material of the mandrel 32 may be tungsten.

The lower surface of the lower pressing head 40 is provided with a second semicircular groove extending along the first direction, the second semicircular groove has a semicircular cross section along the direction perpendicular to the first direction, the lower pressing head 40 is used for pressing the rest of the flexible conductive soft board 10 against the core rod 32, after the upper surface of the base 30 and the lower surface of the lower pressing head 40 are close to each other, a circular hole formed by the first semicircular groove 31 and the second semicircular groove and extending along the first direction is matched with the shape of the flexible conductive soft board 10 after being rolled.

Therefore, a part of the flattened flexible conductive soft board 10 is pressed into the first semicircular groove 31 by the core rod 32, and the rest part of the flexible conductive soft board 10 is pressed and attached to the core rod 32 by the lower pressure head 40, so that the flexible conductive soft board 10 is rolled in the process that the upper surface of the base 30 and the lower surface of the lower pressure head 40 are close to each other, the operation is simple, the rolling efficiency is high, and the actual application requirement can be met.

In some embodiments, the first lifting assembly 50 may include a first bracket 51, a first lifting drive mechanism 52, and a second bracket 53, and may further include an adjustment assembly 54.

The first bracket 51 may be provided on the base 30.

The first lifting driving mechanism 52 may be disposed on the first bracket 51, and the first lifting driving mechanism 52 may drive the second bracket 53 to lift.

The first support 51 may be provided with a first lifting rail 511, the second support 53 may be connected to the first lifting rail 511 in a lifting manner, the first lifting driving mechanism 52 may include a first connecting member 521 and a first lifting screw, the first connecting member 521 is connected to the second support 53, and the first lifting screw is connected to the first connecting member 521 to drive the first connecting member 521 to lift.

In some embodiments, 2 first lifting rails 511 may be disposed on the first bracket 51.

The second bracket 53 may be provided with a first fixing piece 531 and a second fixing piece 532, where the first fixing piece 531 and the second fixing piece 532 are used to fix two ends of the mandrel 32 respectively, and the second bracket 53 drives the mandrel 32 to lift through the first fixing piece 531 and the second fixing piece 532.

In some embodiments, the mandrel 32 may be movable relative to the base 30; the base 30 is movable relative to the mandrel 32; or the mandrel 32 and the base 30 may be moved toward each other. Thereby, the position of the base 30 and/or the core rod 32 can be flexibly adjusted.

In some embodiments, the adjusting assembly 54 may be disposed on the second bracket 53, and the adjusting assembly 54 may be coupled to the first fixture 531 to adjust a distance between the first fixture 531 and the second fixture 532.

In some embodiments, the second bracket 53 may include a first sidewall 533, a second sidewall 534, a third sidewall 535, and a bottom wall 536, the second sidewall 534 and the third sidewall 535 are disposed opposite to each other, the second fixing member 532 may be disposed on the second sidewall 534, the bottom wall 536 is connected to the third sidewall 535, the adjusting assembly 54 may include an adjusting handle 541 and a sliding member 542, the sliding member 542 is slidably disposed on the bottom wall 536 in a first direction, the first fixing member 531 is disposed on the sliding member 542, the adjusting handle 541 is mounted on the third sidewall 535, and the adjusting handle 541 is connected to the sliding member 542 to adjust a distance between the first fixing member 531 and the second fixing member 532.

In some embodiments, the second elevating driving mechanism 60 may be disposed on the second bracket 53, and the second elevating driving mechanism 60 is configured to drive the lower ram 40 to elevate.

In some embodiments, a second lifting guide rail 537 may be disposed on the second bracket 53, the lower ram 40 is connected to the second lifting guide rail 537 in a lifting manner, and the second lifting driving mechanism 60 includes a second connecting member 61 and a second lifting screw, the second connecting member 61 is connected to the lower ram 40, and the second lifting screw is connected to the second connecting member 61 to drive the second connecting member 61 to lift.

In some embodiments, 2 second lifting rails 537 may be disposed on the second bracket 53.

In some embodiments, the lower ram 40 may be movable relative to the base 30; the base 30 is movable relative to the lower ram 40; or the lower ram 40 and the base 30 may be moved toward each other. Thereby, the position of the base 30 and/or the lower ram 40 can be flexibly adjusted.

In some embodiments, the method for manufacturing the stimulating electrode may further include: before step S202 or step S302, an adhesive is coated on the outer surface of the liner tube 20, and/or a lubricant is coated on the outer surface of the mandrel 32, so that the mandrel 32 can be conveniently and smoothly taken out by coating the lubricant.

In some embodiments, the method for manufacturing the stimulating electrode may further include: before step S202 or step S302, an adhesive is coated on the second surface of the flexible conductive flexible board 10. The inner liner tube 20 and the flexible conductive flexible sheet 10 can be firmly bonded by applying an adhesive.

The adhesive can be UV adhesive, or glue with the model number of MED6360 or MG 2502. The lubricant may be vaseline. The glue cannot overflow the width of the flexible conductive flexible board 10 during the rounding process.

In some embodiments, the method for manufacturing the stimulating electrode may further include: the flexible conductive flexible board 10 is heated before step S203 or after step S303. After heating to 100 ℃, the heat can be preserved for 10 minutes, so that the round flexible conductive soft board 10 is shaped.

In some embodiments, the stimulating electrode may further include an outer sleeve 24, the outer sleeve 24 may be provided with a third opening and a fourth opening, and the method of manufacturing the stimulating electrode may further include:

Before step S203, the coiled flexible conductive flexible board 10 is inserted into the outer sleeve 24, so that the third opening of the outer sleeve 24 corresponds to the first opening 12a of the insulating layer, and the fourth opening of the outer sleeve 24 corresponds to the second opening 14a of the insulating layer.

In some embodiments, the stimulating electrode may further include an outer sleeve 24, and the method of making the stimulating electrode may further include:

Before step S203 or after step S303, the coiled flexible conductive flexible printed circuit board 10 is inserted into the outer sleeve 24, so that the outer sleeve 24 is located only outside the middle section 10b of the flexible conductive flexible printed circuit board 10.

In some embodiments, the method for manufacturing the stimulating electrode may further include: before step S203 or after step S303, after the flexible conductive flexible board 10 is inserted into the outer sleeve 24, the outer sleeve 24 is heat shrunk by using a heat shrink tube, and the heat shrink tube is taken out. After completion of the heat shrinkage, the outer diameter of the outer sleeve 24 may be 1.25mm. The outer sleeve 24, the flexible conductive flexible sheet 10 and the inner liner 20 are formed into a unitary structure by heat shrinking.

In some embodiments, the flexible conductive flexible board 10 may further include a plurality of stimulating contacts 15 and a plurality of connecting contacts 16 on the insulating layer, the plurality of stimulating contacts 15 are located on the stimulating section 10a of the flexible conductive flexible board 10 and are distributed at intervals, the plurality of connecting contacts 16 are located on the connecting section 10c of the flexible conductive flexible board 10 and are distributed at intervals, one first conductor 121 is disposed in each first opening 12a, one second conductor 141 is disposed in each second opening 14a, each stimulating contact 15 is connected to at least one first conductor 121, and each connecting contact 16 is connected to at least one second conductor 141.

The manufacturing method of the stimulating electrode can further comprise the following steps: in at least one step, the plurality of stimulation contacts 15 and/or the plurality of connection contacts 16 are thickened, an insulating material is filled at the gaps between the plurality of stimulation contacts 15, and/or an insulating material is filled at the gaps between the plurality of connection contacts 16, after which the insulating material, the stimulation contacts 15, the connection contacts 16 are flush with the outer surface of the outer sleeve 24. Wherein, the insulating material can be PDMS (polydimethylsiloxane).

In some embodiments, the insulating material is filled at the gaps between the plurality of stimulation contacts 15, and/or the insulating material is filled at the gaps between the plurality of connection contacts 16 may be: 3D printing filling; or the outer surface of the flexible conductive soft board 10 after being rolled is covered with an insulating material, and the stimulation contact 15 and/or the connection contact 16 are exposed by laser cutting.

In some embodiments, the method for manufacturing the stimulating electrode may further include: after the insulating material is filled, the stimulation electrode is entirely sleeved with a heat shrinkage tube, and the heat shrinkage is performed again.

In some embodiments, the method for manufacturing a stimulation electrode further comprises: in at least one step, a plurality of first conductive guard layers, each covering one stimulation contact 15, and a plurality of second conductive guard layers, each covering one connection contact 16, are formed on the insulating layer.

In some embodiments, the method for manufacturing the stimulating electrode may further include: in at least one step, an insulating film is formed on the first conductive shield layer and/or the second conductive shield layer.

In some embodiments, the method for manufacturing the stimulating electrode may further include: in at least one step, a locking ring 21 is fixedly fitted over the outer sleeve 24 corresponding to the intermediate section 10b and adjacent to the connection section 10c of the stimulation electrode.

In some embodiments, locking ring 21 may be deformed by pressing with a pair of pliers to tightly couple locking ring 21 with outer sleeve 24. After the fixation of the locking ring 21 is completed, the length of the locking ring 21 may be 2.5mm, the outer diameter of the locking ring 21 may be 1.25mm±0.02, and the distance between the locking ring 21 and the end face of the connection section 10c may be 23.2mm, for example.

In some embodiments, the stimulating electrode may further include a first support tube 22 and/or a second support tube 23, and the method of manufacturing the stimulating electrode may further include:

In at least one step, inserting the first support tube 22 within the liner tube 20 adjacent the stimulation section 10a to increase the rigidity of the stimulation section 10a of the stimulation electrode; and/or the number of the groups of groups,

In at least one step, the second support tube 23 is inserted into the liner tube 20 adjacent to the connection section 10c to increase the rigidity of the connection section 10c of the stimulation electrode.

In some embodiments, glue is applied to the inner wall of the liner tube 20 of the stimulation electrode prior to insertion of the first support tube 22 and/or the second support tube 23.

In some embodiments, the first support tube 22 may extend from an end of the liner tube 20 near the stimulation section 10a, and the method for manufacturing the stimulation electrode may further include: in at least one step, the protruding portion of the first support pipe 22 is made into a rounded end surface.

The present application has been described in terms of its practical and advantageous aspects, such as objectives, performance, improvements and novelty, which are all the functional improvements and advantages that will be emphasized by the patent laws, the above-described and accompanying drawings are merely preferred embodiments of the present application and not intended to limit the application thereto, and therefore all similar or identical structures, devices, features, etc. that are used in accordance with the application are included in the scope of the application.

Claims

1. The stimulation electrode is characterized by comprising a flexible conductive soft board, wherein the flexible conductive soft board is divided into a stimulation section, a connection section and a middle section positioned between the stimulation section and the connection section, the stimulation section and the connection section are respectively in a cylindrical structure, and the middle section is in a cylindrical structure, a spiral structure or a flattened wavy flexible conductive soft board which is formed by rolling;

The outer surface of the stimulation section of the flexible conductive soft board is provided with a plurality of stimulation contacts, the outer surface of the connection section of the flexible conductive soft board is provided with a plurality of connection contacts, a plurality of conductive layers extending along the length direction of the flexible conductive soft board are embedded in the flexible conductive soft board, and the connection contacts are electrically connected with at least one stimulation contact through at least one conductive layer;

the stimulation contacts are divided into a plurality of groups along the length direction of the flexible conductive soft board, and each group of stimulation contacts comprises three sheet-shaped stimulation contacts which are distributed on the outer surface of the stimulation section at equal intervals along the circumferential direction.

2. The stimulation electrode of claim 1, wherein the stimulation contacts are one or more of annular, linear, dot-like or sheet-like, the annular stimulation contacts being circumferentially distributed on the outer surface of the stimulation section, the linear stimulation contacts being circumferentially distributed on the outer surface of the stimulation section or being distributed along the length of the flexible conductive flexible sheet.

3. The stimulation electrode of claim 1, wherein one of said connection contacts is electrically connected to one stimulation contact via a conductive layer.

4. The stimulation electrode of claim 1, wherein the spacing between adjacent two stimulation contacts along the length of the flexible conductive flexible sheet is 0.5mm,1mm or 1.5mm.

5. The stimulating electrode of claim 1 wherein said connection contacts are annular in shape, said annular connection contacts being circumferentially distributed on an outer surface of said connection section, a plurality of said connection contacts being spaced apart.

6. The stimulation electrode according to claim 1, wherein the plurality of conductive layers are distributed on at least two layers of the flexible conductive flexible board having different thicknesses in a thickness direction of the flexible conductive flexible board, at least a portion of the at least two conductive layers overlapping in the thickness direction of the flexible conductive flexible board.

7. The stimulation electrode of claim 1, wherein the stimulation electrode further comprises:

The lining pipe is arranged in the stimulation section, the middle section and the connecting section of the flexible conductive soft board;

A first support tube disposed within the lined tube proximate the stimulation section to increase the rigidity of the stimulation section of the stimulation electrode and/or a second support tube disposed within the lined tube proximate the connection section to increase the rigidity of the connection section of the stimulation electrode;

the outer sleeve is arranged outside the middle section of the flexible conductive soft board and is close to the flexible conductive soft board;

the locking ring is fixedly sleeved on the outer sleeve corresponding to the middle section and is adjacent to the connecting section of the stimulating electrode.

8. The stimulating electrode of claim 7 wherein the first support tube extends from an end of the liner tube adjacent the stimulating segment, the extension of the first support tube having a rounded end surface.

9. The stimulation electrode is characterized by comprising a flexible conductive soft board, wherein the flexible conductive soft board is divided into a stimulation section, a connection section and a middle section positioned between the stimulation section and the connection section, the stimulation section and the connection section are respectively in a cylindrical structure, and the middle section is in a cylindrical structure, a spiral structure or a flattened wavy flexible conductive soft board which is formed by rolling;

The plurality of stimulation contacts comprise two annular stimulation contacts and a plurality of sheet-shaped stimulation contacts positioned between the two annular stimulation contacts, the plurality of sheet-shaped stimulation contacts are divided into a plurality of groups along the length direction of the flexible conductive soft board, and each group of stimulation contacts comprises three sheet-shaped stimulation contacts which are distributed on the outer surface of the stimulation section at equal intervals along the circumferential direction.

10. The stimulation electrode of claim 9, wherein the stimulation contacts are one or more of annular, linear, dot-like or sheet-like, the annular stimulation contacts being circumferentially distributed on the outer surface of the stimulation section, the linear stimulation contacts being circumferentially distributed on the outer surface of the stimulation section or being distributed along the length of the flexible conductive flexible sheet.

11. The stimulation electrode of claim 9, wherein one of said connection contacts is electrically connected to one stimulation contact via a conductive layer.

12. The stimulation electrode of claim 9, wherein the spacing between adjacent two stimulation contacts along the length of the flexible conductive flexible sheet is 0.5mm,1mm or 1.5mm.

13. The stimulating electrode of claim 9 wherein said connection contacts are annular in shape, said annular connection contacts being circumferentially distributed on an outer surface of said connection section, a plurality of said connection contacts being spaced apart.

14. The stimulation electrode according to claim 9, wherein the plurality of conductive layers are distributed on at least two layers of the flexible conductive flexible board having different thicknesses in a thickness direction of the flexible conductive flexible board, at least a portion of the at least two conductive layers overlapping in the thickness direction of the flexible conductive flexible board.

15. The stimulation electrode of claim 9, wherein the stimulation electrode further comprises:

16. The stimulation electrode of claim 15, wherein the first support tube protrudes from an end of the liner tube proximate the stimulation section, the protruding portion of the first support tube having a rounded end surface.