CN119034107A

CN119034107A - Nerve stimulation device

Info

Publication number: CN119034107A
Application number: CN202411539540.7A
Authority: CN
Inventors: 陈风顺; 王守东; 汪伟林
Original assignee: Hangzhou Shenluo Medical Technology Co ltd
Current assignee: Hangzhou Shenluo Medical Technology Co ltd
Priority date: 2024-10-31
Filing date: 2024-10-31
Publication date: 2024-11-29
Anticipated expiration: 2044-10-31
Also published as: CN119034107B

Abstract

The present invention provides a neural stimulation device, comprising an electrode with a through-channel, a limiting seat, a puncture needle and an extracorporeal pulse generator detachably mounted on the limiting seat; the electrode comprises an implantation section and a connection section, the connection section being fixed on the limiting seat; the limiting seat is provided with a first through hole for the implantation section to pass through; the puncture needle is inserted into the through-channel of the electrode so that the electrode reaches the target position; when the extracorporeal pulse generator is mounted on the limiting seat, the extracorporeal pulse generator is electrically connected to the connection section on the limiting seat. The present application directly uses the puncture needle to guide the electrode to the target position, making the implantation step simpler and more convenient, which not only greatly reduces the requirements for the operator, but also reduces the risk of wound infection; at the same time, it also reduces the size of the wound when the electrode is implanted, reducing the burden on the organism.

Description

Nerve stimulation device

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a nerve stimulation device.

Background

The nerve stimulating device is a medical apparatus for treating nerve diseases and mainly comprises an electrode and an external pulse generator. Wherein the electrodes are provided separately from the external pulse generator.

At present, the nerve stimulation device is implanted and used in the process that a trocar is formed by a puncture needle and a guide tube, the trocar is implanted into a living body by utilizing the puncture function of the puncture needle, then the puncture needle is withdrawn, the guide tube is kept at an implantation position, then an electrode is inserted into the guide tube to enter a target position along the guide tube, finally the guide tube is withdrawn, the electrode implanted into the body is connected with an external pulse generator, the whole implantation process is complicated in steps, an operator is not easy to align when inserting the electrode into the guide tube, and the operation requirement on the operator is high, so that the rapid and convenient implantation of the electrode is not facilitated.

Disclosure of Invention

In view of the above-mentioned drawbacks of the prior art, the present application is directed to a nerve stimulation device, in which a puncture needle is inserted into an inner hole of an electrode before implantation, so that when the puncture needle is inserted into a living body, the electrode sleeved outside the puncture needle can enter the living body along with the puncture needle and reach a target position.

In order to achieve the above and other related objects, the application provides an external pulse generator which comprises an electrode with a through channel, a limiting seat, a puncture needle and a detachable mounting on the limiting seat, wherein the electrode comprises an implantation section and a connecting section, the implantation section comprises at least one stimulation piece, the connecting section is provided with a connecting contact in conductive communication with the stimulation piece, the connecting section of the electrode is fixed on the limiting seat, a first through hole for the implantation section to pass through is arranged on the limiting seat, the puncture needle is arranged in the through channel of the electrode in a penetrating way so that the electrode reaches a target position, and when the external pulse generator is mounted on the limiting seat, the external pulse generator is in conductive communication with the connecting section on the limiting seat. When the nerve stimulation device is used, the electrode is directly guided to the target position by the aid of the puncture needle, compared with the traditional trocar consisting of the guide tube and the puncture needle, the puncture needle is pulled out along the first through hole after the electrode reaches the target position, so that the implantation section of the electrode is kept in the organism, and finally, the extracorporeal pulse generator is fixed on the limit seat, so that the extracorporeal pulse generator is in conductive communication with the connecting section on the limit seat, and an electric pulse signal generated by the extracorporeal pulse generator is transmitted to the target position through the electrode to complete the application of electric stimulation.

Preferably, one end of the implantation section far away from the connecting section is a stop end, the stop end is used for positioning the insertion depth of the puncture needle when the puncture needle is inserted into the electrode so that the puncture end of the puncture needle partially or completely protrudes out of the electrode, thus, when the puncture needle is inserted into a living body, the electrode can enter the living body along with the puncture needle to ensure the smoothness of electrode implantation, and in addition, the relative position of the electrode and the puncture needle is kept unchanged in the process of inserting the puncture needle into the living body, therefore, the implantation position of the electrode can be accurately controlled only by guiding the puncture position and the puncture depth of the puncture needle by utilizing ultrasound, and the accuracy of the electrode implantation position is effectively improved.

The puncture end of the puncture needle is of a sharp structure, the stop end is of a hollow structure and is provided with a stop piece for stopping the puncture end from going deep, the puncture end of the sharp structure can ensure that the puncture needle successfully penetrates into a living body, and the stop piece can ensure that the relative position of the electrode and the puncture needle cannot be changed in the puncture process of the puncture needle, so that the electrode can be successfully implanted in place.

Preferably, the puncture end of the puncture needle is in a conical structure with an outer conical surface, and the stop piece is an inner conical surface matched with the outer conical surface so as to position the insertion position of the puncture needle through the matching of the outer conical surface and the inner conical surface.

Preferably, the whole stop end is in an inverted cone table shape so as to avoid the transition tearing wound of the electrode in the implantation process and increase the burden of organisms.

The external pulse generator comprises a shell and a circuit board for generating pulse signals, wherein the circuit board is positioned in the shell, first conductive columns which are in one-to-one correspondence with the connecting contacts on the connecting section are arranged on the circuit board, one end, close to the surface of a living body, of the shell is inserted into the limiting seat so as to conduct the first conductive columns with the corresponding connecting contacts, one end, close to the surface of the living body, of the shell is detachably fixed on the surface of the living body, and/or the shell is detachably and fixedly connected with the limiting seat. The nerve stimulation device can realize the connection of the external pulse generator and the electrode without extending a lead, and the external pulse generator, the limiting seat and the surface of the organism can be relatively fixed, so that the nerve stimulation device is not easily influenced by the activity of the organism, the problems of stimulation interruption, electrode displacement caused by traction and the like caused by the stretch-break of the extending lead are effectively avoided, and the stability and the effectiveness of nerve stimulation are ensured.

Because the external pulse generator and the limiting seat can be in plug-in fit, the volume of the external pulse generator and the limiting seat after assembly is effectively reduced, and therefore the interference of the activities of a patient on the nerve stimulation device can be further reduced.

Preferably, the shell is provided with a slot for exposing the first conductive column at one end close to the surface of the organism, and the external pulse generator is inserted on the limiting seat through the slot.

Preferably, the limiting seat comprises a limiting plate and a plurality of first locking claws formed on the limiting plate, and the first through holes are formed on the limiting plate; the first locking claw is matched with the corresponding first locking piece to be locked when the external pulse generator is inserted on the limiting seat, so that the external pulse generator is limited to be pulled out.

Preferably, the first locking piece is a first locking piece or a first locking groove formed on the inner wall of the slot, and the user can set the first locking piece or the first locking groove according to the situation.

Preferably, a first elastic sealing pad for sealing the inner hole of the electrode is arranged on the limiting seat, a first guide-in gap for a puncture needle to pass through is arranged on the first elastic sealing pad, and when the puncture needle is pulled out, the first guide-in gap of the first elastic sealing pad resets to seal the inner hole of the electrode so as to prevent external pollutants from entering the organism along the inner hole of the electrode to cause wound infection.

The first elastic sealing pad covers the whole connecting section, a second through hole for the first conductive column to pass through is formed in the first elastic sealing pad, a second elastic sealing pad for sealing a puncture wound is arranged at the bottom of the limiting seat, and the second elastic sealing pad is configured to hold the implanting section tightly when the implanting section passes through the second elastic sealing pad. The second elastic sealing gasket can effectively avoid sweat generated on the surface of an organism from spreading to the connecting section along the first through hole of the limiting seat, so that the problems of contact oxidation, circuit short circuit and the like are caused.

Preferably, a circumferential sealing groove is formed in the outer wall of the limiting plate, and a sealing ring is arranged in the circumferential sealing groove. The arrangement of the sealing ring can avoid sweat generated on the surface of an organism from spreading to the connecting section along the gap between the slot and the limiting seat, thereby causing the problems of contact oxidation, circuit short circuit and the like.

The electrode comprises a columnar flexible circuit board, the implantation section is a stimulation section of the columnar flexible circuit board, the connection section is formed by connection contact sections of the columnar flexible circuit board, the columnar flexible circuit board comprises a flexible insulating substrate, a pattern conducting layer and a flexible insulating coating layer which are sequentially arranged from inside to outside, the pattern conducting layer comprises electrode contacts positioned on the stimulation piece, connection contacts positioned on the connection contact sections and conducting circuits used for communicating the electrode contacts with corresponding connection contacts, a plurality of axial dividing lines are arranged on the connection contact sections, the connection contact sections are divided into a plurality of fixing petals by the axial dividing lines so that the connection contacts are positioned on different fixing petals, and the fixing petals are bent to form the connection section of the electrode.

Preferably, the stimulation piece comprises an electrode contact, the electrode contact is of an annular structure, the electrode contact farthest from the connecting contact section is a first electrode contact, snake-shaped wiring grooves for the conductive lines to pass through are formed in all other electrode contacts except the first electrode contact, and the omni-directional stimulation function of each electrode contact can be guaranteed by reasonably distributing the conductive lines.

Preferably, the columnar flexible circuit board is formed by curling a planar flexible circuit board, so that the processing difficulty and the processing cost of the columnar flexible circuit board are reduced.

As described above, the nerve stimulating device of the present invention has at least the following beneficial effects:

Compared with the traditional implantation mode of firstly inserting a trocar consisting of a guide tube and a puncture needle and then pulling out the puncture needle, the nerve stimulation device provided by the application has the advantages that the implantation step is simpler, more convenient and quicker, the requirement on operators is reduced, the time required by the whole implantation process is shortened, the risk of wound infection is greatly reduced, and in addition, the locking of the relative positions of the electrode and the puncture needle is greatly reduced, and in addition, the implantation position and the implantation depth of the electrode can be accurately controlled only by utilizing the puncture position and the puncture depth of the ultrasonic guide puncture needle before implantation, so that the accuracy of the implantation position of the electrode is effectively improved, and the defect that repeated puncture is required due to inaccurate implantation position of the electrode is avoided.

In addition, the first elastic sealing pad is arranged on the limiting seat so as to seal the inner hole of the electrode when the puncture needle withdraws from the electrode, thereby avoiding wound infection caused by external pollutants entering the organism along the inner hole of the electrode, the second elastic sealing pad can be arranged at the bottom of the limiting seat and is configured to tightly hold the implantation section when the implantation section is arranged on the second elastic sealing pad in a penetrating way so as to avoid the problems of contact oxidation, circuit short circuit and the like caused by sweat generated on the surface of the organism spreading to the connecting section along the first through hole of the limiting seat, and of course, in order to avoid the sweat generated on the surface of the organism spreading to the connecting section along the gap between the slot and the limiting seat, a sealing ring can be arranged on the outer wall of the limiting plate so as to prevent the sweat spreading by the sealing ring.

Finally, the connecting section of the electrode and the limiting seat are fixed together, so that the limiting seat can be directly pressed and stuck on the surface of a living body after the electrode reaches the target position, the stable fixation after the electrode implantation is finished, the whole fixation process is convenient and quick and convenient to realize, in addition, the application eliminates an extension lead, only the external pulse generator is required to be inserted and fixed on the limiting seat, the electric connection between the external pulse generator and the connecting section can be finished, and meanwhile, the external pulse generator and/or the limiting seat can be stuck and fixed on the surface of the living body without the interference of the extension lead, so that the nerve stimulation device is not easily influenced by the living body activity, the problems of electrode displacement, connection interruption and the like caused by the living body activity are effectively reduced, and the stability and the effectiveness of nerve stimulation are ensured.

Drawings

Fig. 1 is a state diagram of a nerve stimulation device of the present invention prior to implantation.

Fig. 2 is a state diagram of the nerve stimulating device of the present invention after implantation.

Fig. 3 is a state diagram of the nerve stimulation device (looking upward and upward) after the needle is withdrawn from the electrode.

Figure 4 is an isometric view of an electrode in an example embodiment of the invention.

Fig. 5 is a perspective view of a limiting seat according to an embodiment of the invention.

Fig. 6 is a perspective view of the electrode mounted on the stopper.

Fig. 7 is a schematic view of the structure of the first elastic sealing gasket when sealing the inner hole of the electrode.

Fig. 8 is a state diagram of the puncture needle penetrating through the electrode inner hole.

Figure 9 is an isometric view of the needle.

Fig. 10 is a perspective exploded view of an in vitro pulse generator.

Fig. 11 is a perspective view of the upper housing.

Fig. 12 is a top view of a lower housing according to an embodiment of the present invention inserted on a limiting seat.

Fig. 13 is a cross-sectional view taken along the direction A-A of fig. 12.

Fig. 14 is a schematic diagram illustrating the cooperation between the lower housing and the limiting seat according to another embodiment of the present invention.

Fig. 15 is a schematic structural diagram of a planar flexible circuit board with an insulation coating removed according to an embodiment of the invention.

Fig. 16 is a partial enlarged view of fig. 15 at B.

Fig. 17 is a schematic structural diagram of a planar flexible circuit board with an insulation coating removed according to another embodiment of the present invention.

Fig. 18 is a schematic structural diagram of a post-like flexible circuit board according to an embodiment of the invention after the insulating coating layer is removed.

Fig. 19 is a partial enlarged view of fig. 18 at C.

Fig. 20 is a schematic structural diagram of a post-like flexible circuit board according to another embodiment of the present invention after the insulating coating layer is removed.

Description of the reference numerals

Electrode 1, implant section 11, stimulation member 11a, stopper 111, connection section 12, fixing tab 121, flexible insulating base 13, electrode contact 141, conductive wire 142, connection contact 143, limit seat 2, limit plate 21, first through hole 21a, first seal mounting groove 21b, circumferential seal groove 21c, first lock claw 22, cantilever portion 221, claw portion 222, conductive piece 23, external pulse generator 3, housing 31, lower housing 31a, upper housing 31b, slot 311, first lock groove 312, first lock 313, pressing plate 314, positioning post 315, positioning cylinder 316, second lock groove 317, second lock claw 318, circuit board 32, battery 33, first elastic gasket 4, second through hole 41, puncture needle 5, needle body 51, puncture tip 52, grip 53, second elastic gasket 6, and adhesive layer 7.

Detailed Description

Further advantages and effects of the present invention will become apparent to those skilled in the art from the disclosure of the present invention, which is described by the following specific examples.

Please refer to fig. 1 to 20. It should be understood that the structures, proportions, sizes, etc. shown in the drawings are for illustration purposes only and should not be construed as limiting the invention to the extent that it can be practiced, since modifications, changes in the proportions, or otherwise, used in the practice of the invention, are not intended to be critical to the essential characteristics of the invention, but are intended to fall within the spirit and scope of the invention. Also, the terms such as "upper," "lower," "left," "right," "middle," and "a" and the like recited in the present specification are merely for descriptive purposes and are not intended to limit the scope of the invention, but are intended to provide relative positional changes or modifications without materially altering the technical context in which the invention may be practiced.

The nerve stimulation device is a medical device for applying electric stimulation to target nerves to achieve a therapeutic effect, and comprises an electrode 1 and a pulse generator for providing electric pulse signals for the electrode, wherein the electrode 1 can transmit the electric pulse signals provided by the pulse generator to the target nerves to finish the application of the electric stimulation, the electrode 1 is usually implanted into a living body only for reducing wounds, a puncture needle is required to be inserted into a guide tube to form a trocar firstly, then the trocar is punctured into a target area in the living body under the guidance of ultrasound, the puncture needle is pulled out, the guide tube is left in the living body, then the electrode 1 is inserted into the living body along the inner hole of the guide tube, and after the electrode 1 is implanted in place, the guide tube is required to be pulled out, and then the pulse generator is connected with the external part of the electrode 1 through an extension wire. The whole operation process is complicated, and because the inner hole of the guide tube is smaller, an operator can hardly insert the electrode 1 into the guide tube in an aligned manner, which requires more time and effort, and in addition, because the outer diameter of the guide tube is larger than that of the electrode 1, when the guide tube is inserted into a living body, larger wound is probably caused, and the burden of the living body is increased.

In view of the above, the present invention provides a neural stimulation device, which relates to an electrode 1 having a through channel, and the neural stimulation device can effectively reduce the implantation difficulty and implantation time of the electrode 1, and reduce the trauma when the electrode 1 is implanted. For convenience of description, in the following examples, the piercing direction (i.e., longitudinal direction) of the electrode 1 is defined as the vertical direction, and the upper direction of the sheet in fig. 1 is the upper end and the lower direction of the sheet is the lower end.

Referring to fig. 1 to 8 and 20, the nerve stimulating device according to the present application includes an electrode 1, a limiting seat 2, a puncture needle 5, and an extracorporeal pulse generator 3 detachably mounted on the limiting seat 2.

The electrode 1 is provided with a penetrating channel for penetrating the puncture needle 5, the puncture needle 5 is used for assisting the electrode 1 to reach a target position, the electrode 1 comprises an implantation section 11 and a connecting section 12, the implantation section 11 is of a hollow columnar structure and comprises at least one stimulation piece 11a which is arranged at intervals along the length direction (namely the axial direction) of the implantation section, the stimulation piece 11a is in a ring shape and comprises one electrode contact 141 or a plurality of electrode contacts 141, the connecting section 12 and the implantation section 11 are arranged at a preset angle, the connecting section 12 is provided with the connecting contacts 143 which are connected with the electrode contacts 141 in a one-to-one correspondence manner, the electrode 1 applies electrical stimulation to a target nerve through the electrode contacts 141, and when in treatment, the electrode contacts 141 which are in contact with the target nerve are electrified, and the electrode contacts 141 which are not in contact with the target nerve are not electrified.

The electrode 1 is characterized in that a first through hole 21a for the implantation section 11 to penetrate is formed in the limiting seat 2, when the implantation section 11 of the electrode 1 penetrates into the first through hole 21a, the connecting section 12 of the electrode 1 can be fixed on the limiting seat 2 in a gluing or welding mode and the like to realize the relative fixation of the electrode 1 and the limiting seat 2, after the electrode 1 is implanted into a living body, the inner hole of the electrode 1 is communicated with the internal environment and the external environment, so that wound infection is caused, and in order to prevent external pollutants from entering the living body through the inner hole, a first elastic sealing gasket 4 is required to be arranged on the limiting seat 2 to seal the inner hole of the electrode 1.

When the external pulse generator 3 is arranged on the limiting seat 2, the external pulse generator 3 is in conductive communication with the connecting section 12 on the limiting seat 2 so as to transmit an electric pulse signal generated by the external pulse generator 3 to the electrode 1.

When the nerve stimulation device is used, the puncture needle 5 is inserted into the through channel of the electrode 1 to form a puncture assembly, then the puncture assembly is inserted into a living body under the guidance of ultrasound, the electrode 1 in the puncture assembly is implanted to a target position by using the puncture needle 5, in the process, the limit seat 2 moves along with the electrode 1 due to the fixed connection of the limit seat 2 and the connecting section 12 of the electrode 1, so as to gradually approach the surface of the living body, after the electrode 1 reaches the target position, the limit seat 2 can be directly fixed on the surface of the living body in a manner of pressing (robot pressing or manual pressing), gluing, binding bands and the like, the puncture needle 5 is pulled out, so that the electrode 1 is reserved in the living body, finally the first elastic sealing gasket 4 is arranged on the limit seat 2, and the external pulse generator 3 is arranged on the limit seat 2.

Of course, the first elastic sealing pad 4 may be installed on the limiting seat 2, and a first introducing gap for the puncture needle 5 to pass through is provided on the first elastic sealing pad 4, then the puncture needle 5 is installed on the electrode 1 with the limiting seat 2 to form a puncture assembly, so that when the electrode 1 moves to the target position along with the puncture needle 5 and is fixed, the puncture needle 5 can be directly pulled out, and after the puncture needle 5 is pulled out, the first introducing gap of the first elastic sealing pad 4 automatically contracts to close the inner hole of the electrode 1, thereby further reducing the probability of external pollutants entering the electrode 1.

It will be appreciated that, in order to facilitate replacement of different types of electrodes 1 (e.g. electrodes 1 having different lengths of implant segments 11 or electrodes 1 with different spacing between the implants 11a on the implant segments 11, etc.), to extend the application range of the nerve stimulation device, the connection segments 12 are preferably fixed to the spacing base 2 by a detachable fixing method, including but not limited to gluing or bolting or snapping.

In order to provide the puncture needle 5 with the puncture energy, as shown in fig. 9, the puncture needle 5 includes a needle body 51 and a puncture tip 52 positioned at the bottom end of the needle body 51, the puncture tip 52 is not limited to a sharp structure capable of penetrating a living body, such as a taper structure or a spear structure, and in this embodiment, a holding tip 53 may be provided at the top end of the needle body 51 for facilitating the puncture.

In order to ensure that the electrode 1 can smoothly enter the living body along with the puncture needle 5 and reach the target position, as shown in fig. 4 and 8, one end of the implantation section 11, which is far away from the connection section 12, is a stop end 111, the stop end 111 is of a hollow structure, the stop end 111 is used for positioning the position of the puncture needle 5 inserted into the electrode 1 to avoid excessive insertion of the puncture needle 5, and after the puncture needle 5 is inserted into place, the puncture end 52 of the puncture needle 5 can partially or completely protrude out of the electrode 1. Therefore, after the puncture end 52 of the puncture needle 5 is aligned with the to-be-implanted part of the organism, the puncture needle 5 is forced to puncture the organism and enter the to-be-implanted part, meanwhile, the electrode 1 can move along with the puncture needle 5 to enable the electrode 1 to be implanted into the target position, in the process, the relative position of the electrode 1 and the puncture needle 5 is kept unchanged, and the accuracy of the implantation position of the electrode 1 can be ensured only by accurately controlling the puncture position and the puncture depth of the puncture needle 5 through ultrasonic guidance.

Specifically, the stop end 111 has a stop member for stopping the penetration end 52 from going deep, the structural form of the stop member can be determined according to the structural form of the penetration end 52, for example, when the penetration end 52 has a conical structure with an outer conical surface (the outer conical surface is a conical surface or a pyramid surface), the stop member has an inner conical surface matched with the outer conical surface, for example, the stop member is a stop block arranged in the stop end 111, and the insertion depth of the penetration needle 5 is limited by the stop block, and the specific structural form is not limited as long as the insertion depth of the penetration needle 5 into the inner hole can be limited, in this embodiment, the penetration end 52 of the penetration needle 5 preferably has a conical structure with an inverted conical outer conical surface, and the stop end 111 preferably has a hollow frustum structure with an inner conical surface matched with the outer conical surface.

In a more specific embodiment, the stop end 111 is generally inverted conical in shape to reduce the problem of wound tearing during implantation.

Referring to fig. 1 to 3 and 10, the extracorporeal pulse generator 3 according to the present application comprises a housing 31 detachably mounted on a limiting seat 2 and a circuit board 32 for generating pulse signals, wherein the circuit board 32 is located in the housing 31, and first conductive columns (not shown) corresponding to the connection contacts 143 on the connection section 12 one by one are arranged on the circuit board 32, and the first conductive columns are exposed relative to the housing 31, so that when the housing 31 is mounted on the limiting seat 2, the first conductive columns can be connected with the corresponding connection contacts 143 to realize conductive communication between the extracorporeal pulse generator 3 and the electrode 1.

It can be understood that the housing 31 is mounted on the limiting seat 2 by various existing detachable connection modes such as bolting, buckling, magnetic attraction, inserting and the like, and the specific detachable connection mode is not limited thereto, and in this embodiment, the housing 31 is preferably inserted on the limiting seat 2 to reduce the mounting difficulty of the external pulse generator 3.

It can be understood that the inserting and assembling manner of the housing 31 and the limiting seat 2 includes, but is not limited to, the following two ways:

in the first inserting and assembling mode, the limiting seat 2 serves as a plug, the bottom end (namely, one end close to the surface of a living body) of the shell 31 is provided with a slot 311 for exposing the first conductive column, and the slot 311 is in inserting fit with the limiting seat 2 serving as the plug.

In the second inserting and assembling mode, the bottom end (i.e. the end close to the surface of the living body) of the shell 31 is provided with a plug with the exposed first conductive column, the limiting seat 2 is provided with a slot, and the plug of the shell 31 is in inserting fit with the slot on the limiting seat 2.

In order to reduce the volume of the limit seat 2 and the external pulse generator 3 after assembly, thereby further reducing the influence of the patient's activities on the nerve stimulation device, the first insertion assembly method is preferably adopted in this embodiment.

In order to avoid the case 31 from accidentally separating from the limiting seat 2, the case 31 may be adhered and fixed on the surface of the organism, or the case 31 and the limiting seat 2 may be adhered and fixed on the surface of the organism, and the case 31 and the limiting seat 2 may be relatively fixed at the same time, and the manner of relatively fixing the case 31 and the limiting seat 2 includes, but is not limited to, various existing detachable connection manners such as bolting, fastening, magnetic connection, gluing, etc., which are not limited thereto, and in order to avoid the limiting seat 2 separating from the surface of the organism under the action of the gravity of the external pulse generator 3, and to ensure the connection reliability of the external pulse generator 3 and the limiting seat 2, as shown in fig. 3, in this embodiment, an adhesive layer 7 capable of being adhered on the surface of the organism is preferably provided at the bottom end of the case 31, and the limiting seat 2 is relatively fixed with the case 31 inserted on the limiting seat 2 by using a fastening structure, so that when the external pulse generator 3 is inserted on the limiting seat 2, it can be adhered and fixed with the surface of the organism at the same time, thereby effectively improving the reliability of the relative fixing between the external pulse generator 3, the limiting seat 2 and the surface of the organism.

In an alternative embodiment, as shown in fig. 5, 10, 12, 13 and 14, the limit seat 2 comprises a limit plate 21 and a plurality of first locking claws 22 formed on the limit plate 21, a first through hole 21a is formed on the limit plate 21, and the connecting section 12 is horizontally fixed on the limit plate 21, the first locking claws 22 comprise cantilever parts 211 and claw parts 222 positioned outside the free ends of the cantilever parts 211, first guide surfaces 2221 are formed on the claw parts 222, first locking pieces which are matched and locked with the claw parts 222 are formed on the inner wall of the slot 311, and when the external pulse generator 3 is inserted on the limit seat 2, the first locking claws 22 are matched and locked with the corresponding first locking pieces to limit the external pulse generator 3 to be pulled out, that is, when the external pulse generator 3 is inserted in place, the shell 31 is in a snap connection with the limit seat 2.

It will be appreciated that the first locking member is not limited to the first locking groove 312 or the first locking block 313.

When the first locking member is the first locking groove 312, if the external pulse generator 3 is inserted in a direction approaching to the limit seat 2, the bottom of the slot 311 presses the guiding surface 2221 of the corresponding claw portion 222, so that the claw portion 222 deflects inwards until the claw portion 222 reaches the first locking groove 312, and at this time, the claw portion 222 is reset to be engaged with the corresponding first locking groove 312, so as to limit the external pulse generator 3 from being pulled out.

When the first locking member is the first locking block 313, if the external pulse generator 3 is inserted in a direction approaching to the limit seat 2, the first locking block 313 will press the guiding surface 2221 of the corresponding claw portion 222, so that the claw portion 222 deflects inwards until the claw portion 222 passes over the first locking block 313, and at this time, the claw portion 222 is reset to lock with the corresponding first locking block 313, so as to limit the external pulse generator 3 from being pulled out.

In order to ensure the accuracy of the insertion position of the external pulse generator 3, as shown in fig. 12 and 13, the limiting plate 21 needs to be slidably matched with the slot 311 in the insertion direction, and in this embodiment, the cross-sectional profile of the slot 311 is non-circular to ensure that the slot 311 and the limiting plate 21 cannot rotate relatively.

When the external pulse generator 3 is inserted on the limiting seat 2, the first elastic sealing gasket 4 is pressed and deformed to ensure the sealing effect of the inner hole, the pressing plate 314 shown in fig. 9 is required to be formed on the inner wall of the slot 311 to avoid the deformed first elastic sealing gasket 4 pressing the circuit board 32 at the slot 311, and the pressing plate 314 can apply deformation pressure to the first elastic sealing gasket 4 and also can support the circuit board 32 at the slot 311.

Because sweat can be generated by organisms in daily activities, when the limiting plate 21 is thinner, sweat generated on the surface of the organisms can easily reach the top of the limiting plate 21 along the first through hole 21a to be in contact with the connecting section 12, so that the contact on the connecting section 12 is easily oxidized and disabled, and the problem of circuit short circuit is easily caused.

In view of this, as shown in fig. 3, 13 and 14, the bottom of the limiting plate 21 is provided with a second sealing installation groove, a second elastic sealing pad 6 for sealing the puncture wound is installed in the second sealing installation groove, and the second elastic sealing pad 6 is configured to tightly hold the implant section 11 when the implant section 11 is penetrated through the second elastic sealing pad 6, so as to prevent sweat from penetrating into the connecting section 12 along the gap between the first through hole 21a and the implant section 11.

In addition, sweat may also reach the connecting section 12 at the top of the limiting plate 21 along the gap between the limiting seat 2 and the slot 311, and examples of solving this problem include, but are not limited to, the following.

Example 1

As shown in fig. 5 and 13, a circumferential seal groove 21c is formed in the outer wall of the limiting plate 21, and a seal ring (not shown) is disposed in the circumferential seal groove 21c, so that sweat is prevented from reaching the connecting section 12 at the top of the limiting plate 21 along the gap between the limiting seat 2 and the slot 311 by the seal ring.

Example two

As shown in fig. 6 and 7, the first elastic sealing pad 4 needs to cover the whole connecting section 12, the first elastic sealing pad 4 is provided with a second through hole for the first conductive column to pass through, when the external pulse generator 3 is inserted on the limiting seat 2, the first conductive column on the circuit board 32 can pass through the second through hole of the first elastic sealing pad 4 to be in contact communication with the corresponding connecting contact 143 on the connecting section 12, and as the first elastic sealing pad 4 is pressed and deformed, the first elastic sealing pad 4 clings to the limiting plate 21, so that sweat reaching the top of the limiting plate 21 along the gap between the limiting seat 2 and the slot 311 is prevented from spreading to the connecting section 12.

Of course, in order to ensure the accuracy of the mounting position of the first elastic packing 4, as shown in fig. 5 and 6, a first seal mounting groove 21b may be formed on the top surface of the limiting plate 21, and at this time, the connection section 12 is located at the bottom of the first seal mounting groove 21 b.

In addition, in order to ensure the connection stability of the first conductive posts and the corresponding first connection points 143, a conductive sheet 23 capable of being completely attached to the bottom of each first conductive post may be provided on the limiting plate 21 in advance, after the connection section 12 is fixed on the limiting plate 21, each connection point 143 may be connected to the corresponding conductive sheet 23 by welding and/or direct contact, after the first elastic sealing pad 4 is installed on the limiting plate 21, the conductive sheet 23 may be just exposed by the second through hole, so that the first conductive post may just pass through the second through hole to be in contact with the conductive sheet 23 when the external pulse generator 3 is installed on the limiting seat 2.

It should be noted that, in the extracorporeal pulse generator 3, the housing 31 may be an integral structure or a split structure, which is not limited thereto.

When the housing 31 is of unitary construction, it is integrally injection molded from an insulating material such as epoxy or polyurethane or polysulfone.

When the housing 31 is in a split structure, the housing is formed by butting an upper housing 31b with a lower housing 31a (as shown in fig. 10), in order to ensure the butting accuracy of the two housings, a positioning column 315 can be arranged on one of the upper housing 31b and the lower housing 31a, a positioning cylinder 316 matched with the positioning column 315 is arranged on the other of the upper housing 31b and the lower housing 31a, the positioning column 315 is matched with the positioning cylinder 316 to ensure the butting accuracy of the upper housing 31b and the lower housing 31a, and in addition, the upper housing 31b and the lower housing 31a are required to be fixed relatively after being butted, and the relative fixing modes of the upper housing 31b and the lower housing include but are not limited to magnetic attraction connection, buckling connection and bolt connection. The present embodiment preferably employs a snap-fit connection in view of operational convenience and connection reliability. Specifically, as shown in fig. 10 and 11, one of the upper and lower cases 31b and 31a is provided with a second locking claw 318, and the other is provided with a second locking groove 317, and the snap connection of the upper and lower cases is achieved by the cooperation of the second locking claw 318 and the second locking groove 317.

In addition, in the extracorporeal pulse generator 3, the circuit board 32 needs to supply power to provide the electrode 1 with the electrical pulse signal, and the power supply modes of the circuit board 32 include, but are not limited to, the following two modes.

In the first mode, the circuit board 32 is powered by a battery 33 within the housing 31.

The second way of supplying power is that the circuit board 32 is supplied with power from an electrical energy converter. Specifically, the electric energy converter comprises a receiving coil and a transmitting coil, wherein the transmitting coil is positioned outside the shell 31 and used for generating magnetic field energy, and the receiving coil is positioned in the shell 31 and used for receiving the magnetic field energy and converting the magnetic field energy into electric energy so as to supply power to the circuit board 32.

It will be appreciated that the electrode 1 may be of a wide variety of configurations including, but not limited to, the following two embodiments.

Example 1

The electrode 1 is manufactured on the basis of a planar flexible circuit board (i.e. a thin film electrode) having electrode sections for forming the implant sections 11 and connection contact sections for forming the connection sections 12, the specific manufacturing steps of the electrode 1 comprising:

a1, providing a pattern conductive layer on a planar flexible insulating substrate 13 to form a planar flexible circuit board with electrode sections and connection contact sections.

As shown in fig. 15 and 17, the patterned conductive layer includes electrode contacts 141 on the electrode segments, connection contacts 143 on the connection contact segments, and conductive lines 142 for communicating the electrode contacts 141 with the corresponding connection contacts 143, wherein the electrode contacts 141 at the same length position can be mated to form the stimulating elements 11a.

It is understood that the flexible insulating substrate 13 is of a single-layer material structure or a multi-layer material structure, which is not limited thereto. The thickness of the flexible insulating substrate 13 is 100nm to 300 μm.

When the flexible insulating substrate 13 has a single-layer material structure, it is made of various flexible insulating base materials such as Polyimide (PI) or polyethylene terephthalate (PET) or fluorinated ethylene propylene copolymer (FEP) or polyurethane (TPU), which are not limited thereto.

When the flexible insulating substrate 13 is a multi-layer material structure, it includes a top layer structure, a bottom layer structure and a middle layer structure, and can be manufactured by a lamination injection molding method, wherein the top layer structure and the bottom layer structure are made of various flexible insulating substrate materials such as Polyimide (PI) or polyethylene terephthalate (PET) or fluorinated ethylene propylene copolymer (FEP) or polyurethane (TPU), which are not limited, the middle layer structure is a tow layer (i.e. formed by a plurality of longitudinal tows arranged at intervals along the transverse direction) or a woven mesh layer (i.e. formed by longitudinal and transverse braiding of tows), and is made of various materials with higher tensile strength such as silk, polypropylene, polyglycolic acid (PGA), metal, and the like, which are not limited, and the arrangement of the tow layer or the woven mesh layer can effectively enhance the tensile strength of the flexible insulating substrate 13.

After the flexible insulating substrate 13 is prepared, plasma activation treatment is carried out on the flexible insulating substrate 13, and then the pattern conductive layer is arranged, wherein the plasma activation treatment can effectively increase the adhesiveness of the flexible insulating substrate 13, so that the firmness of the arrangement of the pattern conductive layer is ensured.

It is understood that the pattern conductive layer is disposed in the following ways, but not limited to:

The first method is to plate a layer of conductive material on the whole upper surface of the flexible insulating substrate 13, then cover the conductive material with a first mask plate, and ablate and remove the redundant conductive material to obtain the final patterned conductive layer, wherein the first mask plate is manufactured according to the design scheme of the patterned conductive layer, so that the region of the non-patterned conductive layer is exposed.

The second is to cover the flexible insulating substrate 13 with a second mask plate having grooves corresponding to the patterned conductive layer, and spray-plating the grooved regions of the second mask plate with conductive material to obtain the final patterned conductive layer.

The conductive material is made of copper, molybdenum, gold or other conductive materials, the conductive material is not limited to the conductive material, and the thickness of the pattern conductive layer is 120-180 nm.

A2, curling the planar flexible circuit board to enable the edges of the two sides of the planar flexible circuit board to be butted to form columnar electrodes with the pattern conducting layers outside.

The winding of the planar flexible circuit board can be completed by various existing winding mechanisms such as winding mandrels, and the butt joint positions of the two side edges of the planar flexible circuit board are welded by laser.

A3, shielding the contacts in the pattern conductive layer, and then coating an insulating coating on the rest of the columnar electrode to form an insulating coating layer (not shown) covering the conductive line 142, wherein the columnar electrode segment is the implanted segment 11 of the electrode 1.

Further, in order to protect the contacts of the patterned conductive layer, conductive protective coatings including, but not limited to, polytetrafluoroethylene (PTFE) or parylene coatings, which have high stability, may be plated on the electrode contacts 141 and the connection contacts 143.

A4, arranging a plurality of axial dividing lines on the connecting contact section, cutting the connecting contact section along the axial dividing lines to split the connecting contact section into a plurality of fixed petals 121, arranging the connecting contacts 143 on different fixed petals 121, bending the fixed petals 121 to form a state of forming a preset angle with the electrode section, and forming a connecting section 12 of the electrode 1, thereby completing the preparation of the electrode 1.

It is understood that the insulating film layer may be disposed between the A1 step and the A2 step.

It will be appreciated that the electrodes 1 are divided into omni-directional electrodes and directional electrodes. As the name implies, an omni-directional electrode refers to an electrode that can stimulate the target nerve 360 degrees, and a directional electrode refers to an electrode that stimulates a specific direction.

When the electrode 1 is a directional electrode manufactured based on a planar flexible circuit board, the planar flexible circuit board is only required to be provided with a plurality of electrode contacts 141 which are arranged at intervals at the same length position, so that when the planar flexible circuit board is curled to form the columnar electrode 1, the electrode contacts 141 at the same length position can be distributed at intervals along the periphery of the electrode 1 to form annular stimulation pieces 11a, and the stimulation requirements in different directions can be conveniently realized. Because gaps are arranged between the two adjacent electrode contacts 141, the layout of the conductive circuit 142 is convenient, and therefore, the planar flexible circuit board is easy to manufacture.

When the electrode 1 is an omnidirectional electrode manufactured based on a planar flexible circuit board, only one electrode contact 141 can be arranged at each length position of the planar flexible circuit board, the width of the electrode contact 141 needs to be consistent with the width of the planar flexible circuit board, so that when a plurality of electrode contacts 141 need to be arranged on the planar flexible circuit board, the problem that the conductive line 142 cannot be laid (namely, the problem that the conductive line 142 is connected with the plurality of electrode contacts 141) is solved, each electrode contact 141 can be numbered sequentially according to the position of a connecting contact section in a far-to-near mode, namely, the electrode contact 141 furthest from the connecting contact section is defined as a first electrode contact, then a snake-shaped wiring groove 141a (shown in fig. 15 and 16) through which the conductive line 142 passes is arranged on each electrode contact 141 except for the first electrode contact, the situation that one conductive line 412 is connected with the plurality of electrode contacts 141 at the same time can be avoided, each electrode contact 141 except for the first electrode contact 141 is separated into two parts due to the snake-shaped wiring groove 141a, and therefore, after the planar flexible circuit is formed into the planar flexible circuit, the two parts need to be welded into two parts, and each stimulus part can be connected with each stimulus part, namely, the stimulus part can be formed into a stimulus part, and stimulus part can be connected by 360.

Example two

The electrode 1 is manufactured based on a cylindrical flexible circuit board having an electrode section for forming the implant section 11 and a connection contact section for forming the connection section 12, the specific manufacturing steps of the electrode 1 include:

b1, providing a pattern conductive layer on a hollow tubular flexible insulating substrate 13 to form a columnar flexible circuit board with electrode sections and connecting contact sections.

As shown in fig. 18 and 20, the patterned conductive layer includes electrode contacts 141 on the electrode segments, connection contacts 143 on the connection contact segments, and conductive lines 142 for communicating the electrode contacts 141 with the corresponding connection contacts 143, wherein the electrode contacts 141 at the same length position can be mated to form the stimulating elements 11a.

When the flexible insulating substrate 13 is a multi-layer material structure, it includes an inner layer tube, an outer layer tube and an intermediate layer tube, which can be manufactured by an alternative extrusion pipe method, wherein the inner layer tube and the outer layer tube are made of various flexible insulating substrate materials such as Polyimide (PI) or polyethylene terephthalate (PET) or fluorinated ethylene propylene copolymer (FEP) or polyurethane (TPU), which are not limited, the intermediate layer tube is a woven mesh tube (i.e. formed by vertically and horizontally weaving tows) made of various materials with higher tensile strength such as silk, polypropylene, polyglycolic acid (PGA) and metal, which are not limited, and the woven mesh tube can effectively enhance the tensile strength of the flexible insulating substrate 13, and of course, the inner layer tube can also be omitted to reduce the thickness of the flexible insulating substrate 13.

After the flexible insulating substrate 13 is prepared, plasma activation treatment is carried out on the outer surface of the flexible insulating substrate 13, and then the pattern conductive layer is arranged, wherein the plasma activation treatment can effectively increase the adhesiveness of the flexible insulating substrate 13, so that the firmness of the arrangement of the pattern conductive layer is ensured.

the first is to plate a layer of conductive material on the entire upper surface of the flexible insulating substrate 13, then, a third mask is sleeved on the conductive material and the redundant conductive material is ablated to obtain the final patterned conductive layer, and the third mask has a tubular structure manufactured according to the design scheme of the patterned conductive layer, which can expose the region of the non-patterned conductive layer.

And the second is to sleeve a fourth mask plate on the flexible insulating substrate 13, wherein the fourth mask plate is provided with a notch corresponding to the pattern conductive layer, and the notch area of the fourth mask plate is sprayed with conductive material to obtain the final pattern conductive layer.

B2, shielding the contacts in the pattern conductive layer, and then coating an insulating coating on the rest of the columnar flexible circuit board to form an insulating coating layer (not shown) covering the conductive lines 142, wherein the electrode section of the columnar flexible circuit board is the implanted section 11 of the electrode 1.

B3, arranging a plurality of axial dividing lines on the connecting contact section, cutting the connecting contact section along the axial dividing lines to split the connecting contact section into a plurality of fixed petals 121, arranging the connecting contacts 143 on different fixed petals 121, bending the fixed petals 121 to form a state with a preset angle with the electrode section to form a connecting section 12 of the electrode 1, and thus, completing the preparation of the electrode 1.

When the electrode 1 is a directional electrode manufactured based on a columnar flexible circuit board, the columnar flexible circuit board is only required to be ensured to be provided with a plurality of electrode contacts 141 which are arranged at intervals along the circumferential direction at the same length position, and at the moment, each electrode contact 141 at the same length position forms a stimulation piece 11a, so that the electrode contacts 141 at different directions of the stimulation piece 11a are utilized to realize the stimulation demands of different directions. Because gaps are arranged between the two adjacent electrode contacts 141, the conductive circuit 142 is conveniently distributed, and therefore, the columnar flexible circuit board is easy to manufacture.

When the electrode 1 is an omnidirectional electrode manufactured based on a columnar flexible circuit board, only one electrode contact 141 can be arranged at each length position of the columnar flexible circuit board as a stimulation piece 11a, and the electrode contact 141 is of an annular structure, so that when a plurality of electrode contacts 141 are required to be arranged on the columnar flexible circuit board, the problem that the conductive line 142 cannot be laid (namely, the problem that the conductive line 142 is connected with the plurality of electrode contacts 141) is caused, in order to solve the problem, the electrode contacts 141 can be numbered in sequence from far to near according to the position of a connecting contact section, namely, the electrode contact 141 furthest from the connecting contact section is defined as a first electrode contact, and then a snake-shaped wiring groove 141a (shown in fig. 18 and 19) for the conductive line 142 to pass through is formed on each electrode contact 141 except the first electrode contact, so that the situation that one conductive line 412 is simultaneously connected with the plurality of electrode contacts 141 can be avoided on the basis of meeting the requirement of omnidirectional stimulation.

In summary, the nerve stimulation device provided by the application can directly guide the electrode 1 to the target position by using the puncture needle 5, so that the implantation step is simpler, more convenient and quicker, the requirement on operators is reduced, the time required by the whole implantation process is shortened, the risk of wound infection is greatly reduced, the limit seat 2 can be directly pressed and stuck on the surface of a living body after the electrode 1 is implanted in place, the stable fixation of the electrode 1 after the implantation is finished, the axial displacement problem of the electrode 1 after the puncture needle 5 is pulled out is avoided, in addition, the first elastic sealing gasket 4 on the limit seat 2 can seal the inner hole of the electrode 1 after the puncture needle 5 is pulled out, the wound infection caused by external pollutants entering the living body along the inner hole of the electrode 1 is avoided, finally, the extending wire is omitted, the electric connection between the external pulse generator 3 and the connecting section 12 can be completed only by inserting and fixing the external pulse generator 3 on the limit seat 2, meanwhile, the external pulse generator 3 and/or the limit seat 2 can be stuck and fixed on the surface of the living body, the nerve stimulation device is not influenced by the extending wire, the nerve stimulation device is effectively reduced, and the nerve stimulation is effectively and stable stimulation is ensured. After the electrode 1 is implanted in place, the locking of the relative positions of the electrode and the puncture needle is finished before the electrode is implanted in vivo, and the implantation position and the implantation depth of the electrode can be accurately controlled only by utilizing the puncture position and the puncture depth of the ultrasonic guide puncture needle, so that the accuracy of the implantation position of the electrode is effectively improved, and the defect that repeated puncture is needed due to inaccurate implantation position of the electrode is avoided.

In summary, the present invention effectively overcomes the disadvantages of the prior art and has high industrial utility value.

The above embodiments are merely illustrative of the principles of the present invention and its effectiveness, and are not intended to limit the invention. Modifications and variations may be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the invention. Accordingly, it is intended that all equivalent modifications and variations of the invention be covered by the claims, which are within the ordinary skill of the art, be within the spirit and scope of the present disclosure.

Claims

1. A nerve stimulation device, characterized in that it comprises an electrode (1) having a through channel, a stopper (2), a puncture needle (5), and an extracorporeal pulse generator (3) detachably mounted on the stopper (2); the electrode (1) comprises an implantation section (11) and a connection section (12); the implantation section (11) comprises at least one stimulating element (11a), and the connection section (12) has a connection contact (143) electrically connected to the stimulating element (11a); the connection section (12) of the electrode (1) is fixed on the stopper (2);

The limiting seat (2) is provided with a first through hole (21a) for the implantation section (11) to pass through; the puncture needle (5) is inserted into the through channel of the electrode (1) so that the electrode (1) reaches the target position; when the extracorporeal pulse generator (3) is mounted on the limiting seat (2), the extracorporeal pulse generator (3) is electrically connected to the connection section (12) on the limiting seat (2).

2. A neural stimulation device according to claim 1, characterized in that one end of the implant segment (11) away from the connecting segment (12) is a stop end (111); when the puncture needle (5) is inserted into the electrode (1), the stop end (111) is used to locate the insertion position of the puncture needle (5) so that the puncture end (52) of the puncture needle (5) partially or completely protrudes from the electrode (1).

3. A nerve stimulation device according to claim 2, characterized in that the puncture end (52) of the puncture needle (5) is a sharp structure; the stop end (111) is a hollow structure, and the stop end (111) has a stopper for stopping the puncture end (52) from going deeper.

4. A nerve stimulation device according to claim 3, characterized in that the puncture end (52) of the puncture needle (5) is a conical structure with an outer conical surface; and the stopper is an inner conical surface matching the outer conical surface.

5. A nerve stimulation device according to claim 2, characterized in that the stop end (111) is in the shape of an inverted cone as a whole.

6. A neural stimulation device according to any one of claims 1 to 5, characterized in that the extracorporeal pulse generator (3) comprises a shell (31) and a circuit board (32) for generating a pulse signal; the circuit board (32) is located in the shell (31), and the circuit board (32) is provided with a first conductive column corresponding to each connection contact (143) on the connecting section (12); the end of the shell (31) close to the surface of the biological body is inserted into the limit seat (2) so that the first conductive column is connected to the corresponding connection contact (143); the end of the shell (31) close to the surface of the biological body can be detachably fixed to the surface of the biological body, and/or the shell (31) and the limit seat (2) are detachably fixedly connected.

7. A nerve stimulation device according to claim 6, characterized in that a slot (311) for exposing the first conductive column is provided at one end of the shell (31) close to the surface of the biological body, and the extracorporeal pulse generator (3) is inserted into the limit seat (2) through the slot (311).

8. A neural stimulation device according to claim 7, characterized in that the limit seat (2) includes a limit plate (21) and a plurality of first locking claws (22) formed on the limit plate (21), and the first through hole (21a) is opened on the limit plate (21); the slot (311) is provided with a first locking piece that cooperates with the first locking claw (22); when the extracorporeal pulse generator (3) is inserted into the limit seat (2), the first locking claw (22) cooperates with the corresponding first locking piece to lock, so as to limit the removal of the extracorporeal pulse generator (3).

9. A nerve stimulation device according to claim 8, characterized in that the first locking member is a first locking block (313) or a first locking groove (312) formed on the inner wall of the slot (311).

10. A nerve stimulation device according to claim 8, characterized in that a first elastic sealing pad (4) for sealing the inner hole of the electrode (1) is provided on the limiting seat (2), and a first introduction gap for the puncture needle (5) to pass through is provided on the first elastic sealing pad (4).

11. A nerve stimulation device according to claim 10, characterized in that the first elastic sealing pad (4) covers the entire connecting section (12), and the first elastic sealing pad (4) is provided with a second through hole (41) for the first conductive column to pass through; the bottom of the limiting seat (2) is provided with a second elastic sealing pad (6) for sealing the puncture wound; the second elastic sealing pad (6) is configured to hold the implant section (11) when the implant section (11) is inserted into the second elastic sealing pad (6).

12. A nerve stimulation device according to claim 10, characterized in that a circumferential sealing groove (21c) is provided on the outer wall of the limiting plate (21), and a sealing ring is provided in the circumferential sealing groove (21c).

13. A nerve stimulation device according to claim 1, characterized in that the electrode (1) comprises a columnar flexible circuit board; the implantation section (11) is a stimulation section of the columnar flexible circuit board, and the connection section (12) is formed by a connection contact section of the columnar flexible circuit board; the columnar flexible circuit board comprises a flexible insulating substrate (13), a patterned conductive layer and a flexible insulating coating layer arranged in sequence from the inside to the outside; the patterned conductive layer comprises an electrode contact (141) located on the stimulation piece (11a), a connection contact (143) located on the connection contact section and a conductive line (142) for connecting the electrode contact (141) with the corresponding connection contact (143); a plurality of axial dividing lines are provided on the connection contact section, and the axial dividing lines divide the connection contact section into a plurality of fixed petals (121) so that each connection contact (143) is located on a different fixed petal (121); each fixed petal (121) is bent to form the connection section (12) of the electrode (1).

14. A neural stimulation device according to claim 13, characterized in that the stimulation element (11a) includes an electrode contact (141), and the electrode contact (141) is a ring structure; the electrode contact (141) farthest from the connecting contact section is the first electrode contact; and each of the electrode contacts except the first electrode contact is provided with a serpentine wiring groove (141a) for the conductive line (142) to pass through.

15 . A nerve stimulation device according to claim 13 or 14 , characterized in that the columnar flexible circuit board is formed by curling a planar flexible circuit board.