A nerve stimulation device

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 is 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

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a nerve stimulation device. Background Art

[0002] A neurostimulator is a medical device for treating neurological diseases, which mainly includes electrodes and an extracorporeal pulse generator, wherein the electrodes and the extracorporeal pulse generator are provided separately.

[0003] At present, the implantation and use process of the neurostimulation device is as follows: first, the puncture needle and the guide tube are assembled into a trocar, so as to utilize the puncture function of the puncture needle to implant the trocar into the body; then, the puncture needle is withdrawn, and the guide tube is retained at the implantation position; then, the electrode is inserted into the guide tube, so that it enters the target position along the guide tube; finally, the guide tube is withdrawn, and the electrode implanted in the body is connected to the external pulse generator; the entire implantation process is cumbersome, and it is difficult for the operator to align the electrode when inserting it into the guide tube, which places high operational requirements on the operator, and is not conducive to the rapid and convenient implantation of the electrode. Summary of the invention

[0004] In view of the above shortcomings of the prior art, the purpose of the present invention is to provide a neural stimulation device, which inserts a puncture needle into the inner hole of the electrode before implantation, so that when the puncture needle penetrates into the biological body, the electrode mounted on the outside of the puncture needle can enter the biological body and reach the target position; compared with the traditional implantation method of first inserting a sheath needle composed of a guide tube and a puncture needle, and then pulling out the puncture needle to allow the electrode to be inserted into the biological body along the inner hole of the guide tube; the implantation steps of the neural stimulation device of the present application are more convenient and quick, which not only greatly reduces the requirements for operators, but also reduces the risk of wound infection.

[0005] To achieve the above-mentioned purpose and other related purposes, the present invention provides an extracorporeal pulse generator including an electrode with a through-channel, a limiting seat, a puncture needle and a detachable installation on the limiting seat; the electrode includes an implantation section and a connection section; the implantation section includes at least one stimulation piece, and the connection section has a connection contact which is electrically connected to the stimulation piece; the connection section of the electrode is 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 installed on the limiting seat, the extracorporeal pulse generator is electrically connected to the connection section on the limiting seat. When in use, the puncture needle must first be inserted into the inner hole of the electrode, and then, under the guidance of ultrasound, the puncture needle is inserted into the body, so that the electrode is directly guided to the target position by the puncture needle. In this process, since the limit seat is fixedly connected to the connecting section of the electrode, the limit seat will also move along with it to gradually approach the surface of the body; when the electrode reaches the target position, the puncture needle can be directly pulled out along the first through hole so that the implanted section of the electrode continues to remain in the body; finally, the extracorporeal pulse generator is fixed on the limit seat so that the extracorporeal pulse generator is electrically connected to the connecting section on the limit seat; in this way, the electric pulse signal generated by the extracorporeal pulse generator will be transmitted to the target position through the electrode to complete the application of electrical stimulation; because the neural stimulation device of the present application directly uses the puncture needle to guide the electrode to the target position; compared with the traditional implantation method of first inserting a sheath needle composed of a guide tube and a puncture needle, and then pulling out the puncture needle, so that the electrode is inserted into the body along the inner hole of the guide tube, the implantation steps of the present application are simpler and more convenient, which not only greatly reduces the requirements for operators, but also reduces the risk of wound infection.

[0006] Preferably, one end of the implantation section away from the connecting section is a stop end; when the puncture needle is inserted into the electrode, the stop end is used to locate the insertion depth of the puncture needle so that the puncture end of the puncture needle partially or completely protrudes from the electrode; in this way, when the puncture needle is inserted into the biological body, the electrode can follow the puncture needle into the biological body, thereby ensuring the smoothness of the electrode implantation; in addition, since the relative position of the electrode and the puncture needle remains unchanged during the process of the puncture needle being inserted into the biological body, the implantation position of the electrode can be accurately controlled by only using ultrasound to guide the insertion position and insertion depth of the puncture needle, thereby effectively improving the accuracy of the electrode implantation position.

[0007] Preferably, the puncture end of the puncture needle is a sharp structure; the stop end is a hollow structure, and the stop end has a stopper for stopping the puncture end from going deeper; the puncture end with a sharp structure can ensure that the puncture needle can be smoothly inserted into the biological body, and the setting of the stopper can ensure that the relative position of the electrode and the puncture needle will not change during the puncture needle insertion process, thereby ensuring that the electrode can be successfully implanted in place.

[0008] Preferably, the puncture end of the puncture needle is a conical structure with an outer conical surface; the stopper is an inner conical surface that cooperates with the outer conical surface, so as to locate the insertion position of the puncture needle through the cooperation between the outer conical surface and the inner conical surface.

[0009] Preferably, the stop end is in an inverted cone shape as a whole to prevent the electrode from tearing the wound excessively during the implantation process, thereby increasing the burden on the organism.

[0010] Preferably, the extracorporeal pulse generator includes a shell and a circuit board for generating a pulse signal; the circuit board is located inside the shell, and a first conductive column corresponding to each connection contact on the connection section is provided on the circuit board; the end of the shell close to the surface of the organism is inserted into the limit seat to make the first conductive column conductive with the corresponding connection contact; the end of the shell close to the surface of the organism is detachably fixed to the surface of the organism, and / or the shell and the limit seat are detachably fixedly connected. The neural stimulation device of the present application can realize the connection between the extracorporeal pulse generator and the electrode without extending the wire, and because the extracorporeal pulse generator, the limit seat and the surface of the organism can be relatively fixed, it is not easily affected by the activities of the organism, and effectively avoids the problems of stimulation interruption caused by breaking of the extended wire and electrode displacement caused by pulling, thereby ensuring the stability and effectiveness of neural stimulation.

[0011] Since the extracorporeal pulse generator and the limit seat can be plugged together, the volume of the two after assembly is effectively reduced, thereby further reducing the interference of patient activities on the neural stimulation device.

[0012] Preferably, a slot is provided at one end of the shell close to the surface of the biological body to expose the first conductive column, and the extracorporeal pulse generator is inserted into the limit seat through the slot; such a configuration can minimize the volume of the extracorporeal pulse generator and the limit seat after assembly, thereby further reducing the impact of patient activities on the implanted neural stimulation device.

[0013] Preferably, the limit seat includes a limit plate and a plurality of first locking claws formed on the limit plate, and the first through hole is opened on the limit plate; the slot is provided with a first locking piece that cooperates with the first locking claw; when the extracorporeal pulse generator is inserted into the limit seat, the first locking claw cooperates with and locks with the corresponding first locking piece to limit the removal of the extracorporeal pulse generator.

[0014] Preferably, the first locking member is a first locking block or a first locking groove formed on the inner wall of the slot, and the user can set it according to the situation.

[0015] Preferably, the limiting seat is provided with a first elastic sealing pad for sealing the inner hole of the electrode, and the first elastic sealing pad is provided with a first introduction gap for the puncture needle to pass through; when the puncture needle is pulled out, the first introduction gap of the first elastic sealing pad will reset and block the inner hole of the electrode to prevent external contaminants from entering the organism through the inner hole of the electrode and causing wound infection.

[0016] Preferably, the first elastic sealing pad covers the entire connection section, and the first elastic sealing pad is provided with a second through hole for the first conductive column to pass through; the bottom of the limit seat is provided with a second elastic sealing pad for sealing the puncture wound; the second elastic sealing pad is configured to hold the implantation section tightly when the implantation section is inserted into the second elastic sealing pad. The presence of the second elastic sealing pad can effectively prevent the sweat generated on the surface of the organism from spreading to the connection section along the first through hole of the limit seat, causing problems such as contact oxidation and circuit short circuit.

[0017] Preferably, a circumferential sealing groove is formed on the outer wall of the limit plate, and a sealing ring is arranged in the circumferential sealing groove. The provision of the sealing ring can prevent sweat generated on the surface of the organism from spreading along the gap between the slot and the limit seat to the connection section, causing problems such as contact oxidation and circuit short circuit.

[0018] Preferably, the electrode comprises a columnar flexible circuit board; the implantation section is a stimulation section of the columnar flexible circuit board, and the connection section is formed by a connection contact section of the columnar flexible circuit board; the columnar flexible circuit board comprises a flexible insulating substrate, a patterned conductive layer and a flexible insulating coating layer arranged in sequence from the inside to the outside; the patterned conductive layer comprises electrode contacts located on the stimulation piece, connection contacts located on the connection contact section and a conductive circuit for connecting the electrode contacts with corresponding connection contacts; 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 so that each connection contact is located on a different fixed petal; each fixed petal is bent to form a connection section of the electrode; when the present application manufactures electrodes based on a flexible circuit board, more electrode channels can be provided, and the arrangement of the electrode channels is more flexible and convenient, and has a wider range of applications.

[0019] Preferably, the stimulation member includes an electrode contact, and the electrode contact is a ring structure; the electrode contact farthest from the connecting contact segment is the first electrode contact; each of the remaining electrode contacts except the first electrode contact is provided with a serpentine wiring groove for the conductive circuit to pass through; the present application ensures that each electrode contact can achieve omnidirectional stimulation function by reasonably arranging the conductive circuit.

[0020] Preferably, the columnar flexible circuit board is formed by curling a planar flexible circuit board, so as to reduce the processing difficulty and cost of the columnar flexible circuit board.

[0021] As described above, a nerve stimulation device of the present invention has at least the following beneficial effects:

[0022] The neurostimulation device provided by the present invention can directly use the puncture needle to guide the electrode to the target position; compared with the traditional implantation method of first inserting a sheath needle composed of a guide tube and a puncture needle, and then pulling out the puncture needle to allow the electrode to be inserted into the biological body along the inner hole of the guide tube, the implantation steps of the present application are simpler, more convenient, and faster, which not only reduces the requirements for operators, but also shortens the time required for the entire implantation process, greatly reducing the risk of wound infection; in addition, since the present application has completed the locking of the relative position of the electrode and the puncture needle before implantation in the body, it is only necessary to use ultrasound to guide the insertion position and insertion depth of the puncture needle to accurately control the implantation position and implantation depth of the electrode, effectively improving the accuracy of the electrode implantation position, and avoiding the deficiency of repeated punctures due to inaccurate electrode implantation position.

[0023] In addition, the present application sets a first elastic sealing pad on the limiting seat to seal the inner hole of the electrode when the puncture needle withdraws from the electrode, thereby preventing external contaminants from entering the organism along the inner hole of the electrode and causing wound infection; a second elastic sealing pad can be set at the bottom of the limiting seat, and the second elastic sealing pad is configured to hold the implantation section when the implantation section is passed through the second elastic sealing pad, so as to prevent sweat generated on the surface of the organism from spreading along the first through hole of the limiting seat to the connecting section, causing problems such as contact oxidation and circuit short circuit; of course, in order to prevent sweat generated on the surface of the organism from spreading along the gap between the slot and the limiting seat to the connecting section, a sealing ring can be installed on the outer wall of the limiting plate to use the sealing ring to prevent the spread of sweat.

[0024] Finally, the present application fixes the connecting section of the electrode and the limiting seat together, so that after the electrode reaches the target position, the limiting seat can be directly pressed and pasted on the surface of the biological body to complete the stable fixation of the electrode after implantation; the entire fixation process is convenient and fast, and easy to implement; in addition, the present application eliminates the extension wire, and only needs to insert and fix the extracorporeal pulse generator on the limiting seat to complete the electrical connection between the extracorporeal pulse generator and the connecting section; at the same time, since the extracorporeal pulse generator and / or the limiting seat can be pasted and fixed to the surface of the biological body, and there is no interference from the extension wire, the neural stimulation device of the present application is not easily affected by the activities of the biological body, effectively reducing the problems of electrode displacement and connection interruption caused by the activities of the biological body, thereby ensuring the stability and effectiveness of neural stimulation. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 This is a state diagram of the neural stimulation device in the present invention before implantation.

[0026] Figure 2 This is a diagram of the state of the neural stimulation device of the present invention after implantation.

[0027] Figure 3This is a diagram of the status of the neurostimulation device after the puncture needle is withdrawn from the electrode (looking upward).

[0028] Figure 4 FIG. 1 is an isometric view of an electrode according to an embodiment of the present invention.

[0029] Figure 5 It is a three-dimensional diagram of a limiting seat in one embodiment of the present invention.

[0030] Figure 6 This is a three-dimensional diagram of the electrode installed on the limit seat.

[0031] Figure 7 It is a schematic diagram of the structure when the first elastic sealing pad seals the inner hole of the electrode.

[0032] Figure 8 This is a state diagram when the puncture needle is inserted into the inner hole of the electrode.

[0033] Fig. 9 This is an isometric view of a puncture needle.

[0034] Fig.10 This is a three-dimensional exploded view of the extracorporeal pulse generator.

[0035] Fig.11 It is a three-dimensional view of the upper shell.

[0036] Fig.12 This is a top view of the lower shell body installed on the limiting seat according to an embodiment of the present invention.

[0037] Fig.13 for Fig.12 AA section view.

[0038] Fig.14 It is a schematic diagram of the cooperation between the lower shell and the limiting seat according to another embodiment of the present invention.

[0039] Fig.15 This is a schematic diagram of the structure of a flat flexible circuit board after the insulating coating layer is removed in one embodiment of the present invention.

[0040] Fig.16 for Fig.15 A partial enlarged view at point B.

[0041] Fig.17 This is a schematic diagram of the structure of a flat flexible circuit board after the insulating coating layer is removed in another embodiment of the present invention.

[0042] Fig.18 This is a schematic diagram of the structure of a columnar flexible circuit board after the insulating coating layer is removed in one embodiment of the present invention.

[0043] Fig.19 for Fig.18 A partial enlarged view at point C.

[0044] Fig. 20 This is a schematic diagram of the structure of a columnar flexible circuit board after the insulating coating layer is removed in another embodiment of the present invention.

[0045] Description of Reference Numerals

[0046] Electrode 1, implantation section 11, stimulation piece 11a, stop end 111, connection section 12, fixing flap 121, flexible insulating base 13, electrode contact 141, conductive circuit 142, connection contact 143, limit seat 2, limit plate 21, first through hole 21a, first sealing installation groove 21b, circumferential sealing groove 21c, first locking claw 22, cantilever portion 221, claw portion 222, conductive sheet 23, extracorporeal pulse generator 3, shell 31, lower shell 31a, upper shell 31b, slot 311, first locking groove 312, first locking block 313, pressing plate 314, positioning column 315, positioning cylinder 316, second locking groove 317, second locking claw 318, circuit board 32, battery 33, first elastic sealing pad 4, second through hole 41, puncture needle 5, needle body 51, puncture end 52, handle 53, second elastic sealing pad 6, adhesive layer 7. DETAILED DESCRIPTION

[0047] The following is a description of the implementation of the present invention by means of specific embodiments. Those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification.

[0048] See also Figures 1 to 20 . It should be noted that the structures, proportions, sizes, etc. illustrated in the drawings in this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the limiting conditions for the implementation of the present invention, so they have no substantial technical significance. Any modification of the structure, change in the proportional relationship, or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the effects and purposes that can be achieved by the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description, and are not used to limit the scope of the implementation of the present invention. Changes or adjustments in their relative relationships should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0049] A neurostimulator is a medical device that applies electrical stimulation to a target nerve to achieve a therapeutic effect, and includes an electrode 1 and a pulse generator that provides an electrical pulse signal to the electrode; the electrode 1 can transmit the electrical pulse signal provided by the pulse generator to the target nerve to complete the application of electrical stimulation; in order to reduce the wound, usually only the electrode 1 is implanted in the body; because the electrode 1 has a certain flexibility and cannot be directly implanted in the body, the puncture needle must first be inserted into the guide tube to form a cannula needle, and then under the guidance of ultrasound, the cannula needle is punctured to the target area in the body and the puncture needle is pulled out, leaving the guide tube in the body, and then the electrode 1 is inserted into the body along the inner hole of the guide tube; when the electrode 1 is implanted in place, the guide tube must be pulled out, and then the pulse generator is connected to the external part of the electrode 1 through an extended wire. The entire operation process is cumbersome, and due to the small inner hole of the guide tube, it is difficult for the operator to align the electrode 1 and insert it into the guide tube, which requires a lot of time and effort; in addition, since the outer diameter of the guide tube is larger than the outer diameter of the electrode 1, when it is inserted into the organism, it is bound to cause a larger wound, increasing the burden on the organism.

[0050] In view of this, the present invention provides a nerve stimulation device, wherein the electrode 1 involved is an electrode 1 having a through channel, and the electrode 1 can effectively reduce the difficulty and time of implantation of the electrode 1, and reduce the trauma during implantation of the electrode 1. For the convenience of description, in the following embodiments, the puncture direction (i.e., the length direction) of the electrode 1 is defined as the up and down direction; based on this, Figure 1 The upper direction of the paper is the upper end, and the lower direction of the paper is the lower end.

[0051] See also Figures 1 to 8 and Fig. 20 The nerve stimulation device involved in 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.

[0052] Among them, the electrode 1 has a through channel for the puncture needle 5 to pass through, and the puncture needle 5 is used to assist the electrode 1 to reach the target position; the electrode 1 includes an implantation section 11 and a connection section 12; the implantation section 11 is a hollow cylindrical structure, which includes at least one stimulator 11a arranged at intervals along its own length direction (i.e., axial direction); the stimulator 11a is annular as a whole, and includes one electrode contact 141 or multiple electrode contacts 141; the connection section 12 is set at a preset angle to the implantation section 11, and the connection section 12 has a connection contact 143 connected to each electrode contact 141 in a one-to-one correspondence; the electrode 1 applies electrical stimulation to the target nerve through the electrode contact 141. During treatment, the electrode contact 141 in contact with the target nerve is energized, and the electrode contact 141 not in contact with the target nerve is not energized.

[0053] A first through hole 21a is provided on the limiting seat 2 for the implantation section 11 to pass through; when the implantation section 11 of the electrode 1 is passed through the first through hole 21a, the connecting section 12 of the electrode 1 can be fixed on the limiting seat 2 by gluing or welding to achieve relative fixation of the electrode 1 and the limiting seat 2; when the electrode 1 is implanted in a living body, the inner hole of the electrode 1 will connect the internal and external environments of the living body, thereby causing wound infection; in order to prevent external contaminants from entering the living body through the inner hole, a first elastic sealing pad 4 needs to be installed on the limiting seat 2 to seal the inner hole of the electrode 1.

[0054] When the extracorporeal pulse generator 3 is installed on the limiting seat 2 , the extracorporeal pulse generator 3 is electrically connected to the connecting section 12 on the limiting seat 2 to transmit the electric pulse signal generated by the extracorporeal pulse generator 3 to the electrode 1 .

[0055] When using the above-mentioned neural stimulation device, the puncture needle 5 must first be inserted into the through channel of the electrode 1 to form a puncture assembly; then, under the guidance of ultrasound, the puncture assembly is inserted into the biological body, so that the electrode 1 in the puncture assembly is implanted into the target position using the puncture needle 5. During this process, since the limit seat 2 is fixedly connected to the connecting section 12 of the electrode 1, the limit seat 2 will also move along to gradually approach the surface of the biological body; when the electrode 1 reaches the target position, the limit seat 2 can be directly fixed to the surface of the biological body by pressing (robot pressing or manual pressing), gluing, binding, etc., and the puncture needle 5 can be pulled out to leave the electrode 1 in the biological body. inside; finally, the first elastic sealing pad 4 is installed on the limit seat 2, and the extracorporeal pulse generator 3 is installed on the limit seat 2 to realize the electrical connection between the extracorporeal pulse generator 3 and the electrode 1; the neural stimulation device of the present application adopts the electrode 1 with a through channel for electrical stimulation transmission, which has higher flexibility and is not easy to produce rejection reaction compared with the traditional solid electrode; in addition, the present application cancels the guide tube and directly uses the puncture needle 5 to guide the electrode 1 to the target position, making the implantation step simpler and more convenient, which not only reduces the difficulty of operation for the operator, but also greatly shortens the time required for the entire implantation process and reduces the chance of wound infection.

[0056] Of course, the first elastic sealing pad 4 can also be installed on the limiting seat 2 first, and a first introduction gap for the puncture needle 5 to pass through can be set on the first elastic sealing pad 4; then, the puncture needle 5 can be installed on the electrode 1 with the limiting seat 2 to form a puncture assembly; in this way, when the electrode 1 follows the puncture needle 5 to move to the target position and is fixed, the puncture needle 5 can be directly pulled out. After the puncture needle 5 is pulled out, the first introduction gap of the first elastic sealing pad 4 will automatically shrink and close the inner hole of the electrode 1, thereby further reducing the probability of external contaminants entering the electrode 1.

[0057] It can be understood that in order to facilitate the replacement of different types of electrodes 1 (such as electrodes 1 with implant segments 11 of different lengths or electrodes 1 with different arrangement spacings of stimulation members 11a on the implant segments 11, etc.) so as to expand the scope of application of the neurostimulation device, the connecting segment 12 is preferably fixed to the limit seat 2 in a detachable manner, and the detachable fixing method includes but is not limited to gluing or bolting or snap-on connection, which is not limited to.

[0058] In order to provide the puncture needle 5 with puncture energy, Fig. 9 As shown, the puncture needle 5 includes a needle body 51 and a puncture end 52 located at the bottom end of the needle body 51. The puncture end 52 adopts a cone-shaped structure or a spear-shaped structure or other sharp structures that can pierce a biological body, and there is no limitation to this. In this embodiment, in order to facilitate puncture, a gripping end 53 can be set at the top of the needle body 51.

[0059] In order to ensure that the electrode 1 can follow the puncture needle 5 to smoothly enter the body and reach the target position; Figure 4 and Figure 8 As shown, the end of the implantation section 11 away from the connection section 12 is the stop end 111, which is a hollow structure and is used to locate the position where the puncture needle 5 is inserted into the electrode 1 to prevent the puncture needle 5 from being inserted too far; after the puncture needle 5 is inserted into place, the puncture end 52 of the puncture needle 5 can partially or completely protrude from the electrode 1. Therefore, after the puncture end 52 of the puncture needle 5 is aligned with the part to be implanted in the organism and force is applied to the puncture needle 5, the puncture needle 5 can penetrate the organism and enter the part to be implanted. At the same time, the electrode 1 can move with the puncture needle 5 to implant the electrode 1 into the target position. In this process, the relative position of the electrode 1 and the puncture needle 5 remains unchanged. The accuracy of the implantation position of the electrode 1 can be ensured by accurately controlling the puncture position and puncture depth of the puncture needle 5 through ultrasound guidance.

[0060] Specifically, the stop end 111 has a stopper for stopping the puncture end 52 from going deeper; the structural form of the stopper can be determined according to the structural form of the puncture end 52, such as when the puncture end 52 is a conical structure with an outer conical surface (the outer conical surface is a conical surface or a pyramidal surface), the stopper is an inner conical surface that matches the outer conical surface; for example, the stopper is a stop block arranged in the stop end 111, and the stop block is used to limit the insertion depth of the puncture needle 5; there is no limitation on the specific structural form, as long as the depth of the puncture needle 5 inserted into the inner hole can be limited; in this embodiment, the puncture end 52 of the puncture needle 5 preferably adopts a conical structure, which has an inverted cone-shaped outer conical surface; the stop end 111 preferably adopts a hollow frustum structure, which has an inner conical surface that matches the outer conical surface.

[0061] In a more specific embodiment, the stop end 111 is in an overall inverted cone shape to reduce the problem of wound tearing during the implantation process.

[0062] See also Figures 1 to 3 , Fig.10 As shown, the extracorporeal pulse generator 3 involved in the present application includes a shell 31 detachably mounted on the limit seat 2 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 (not shown in the figure) corresponding to each connecting contact 143 on the connecting section 12; the first conductive column is exposed relative to the shell 31, so that when the shell 31 is mounted on the limit seat 2, the first conductive column can be connected to the corresponding connecting contact 143 to realize conductive connection between the extracorporeal pulse generator 3 and the electrode 1.

[0063] It can be understood that the shell 31 is installed on the limit seat 2 by various existing detachable connection methods such as bolt connection, snap connection, magnetic connection or plug-in connection, and the specific detachable connection method is not limited to this; in this embodiment, the shell 31 is preferably plug-in installed on the limit seat 2 to reduce the difficulty of installing the extracorporeal pulse generator 3.

[0064] It is understandable that the plug-in matching modes of the housing 31 and the limit seat 2 include but are not limited to the following two:

[0065] The first plug-in matching mode: the limiting seat 2 acts as a plug, and the bottom end of the shell 31 (i.e., the end close to the surface of the organism) is provided with a slot 311 that exposes the first conductive column, and the slot 311 is plug-matched with the limiting seat 2 acting as a plug.

[0066] The second plug-in matching mode: a plug with the first conductive column exposed is provided at the bottom end of the shell 31 (i.e., the end close to the surface of the organism), and a slot is provided on the limit seat 2, and the plug of the shell 31 is plugged into and matched with the slot on the limit seat 2.

[0067] In order to reduce the volume of the limit seat 2 and the extracorporeal pulse generator 3 after assembly, thereby further reducing the impact of the patient's activities on the nerve stimulation device, this embodiment preferably adopts the first plug-in matching method.

[0068] In order to prevent the shell 31 from accidentally detaching from the limiting seat 2, the shell 31 can be glued and fixed on the surface of the biological body, or the shell 31 and the limiting seat 2 can be relatively fixed, or the shell 31 can be glued and fixed on the surface of the biological body while the shell 31 and the limiting seat 2 are relatively fixed; the methods for achieving relative fixation between the shell 31 and the limiting seat 2 include but are not limited to various existing detachable connection methods such as bolt connection, snap connection, magnetic connection, and adhesion, which are not limited to; in order to prevent the limiting seat 2 from being separated from the surface of the biological body under the action of gravity of the extracorporeal pulse generator 3, and to ensure the reliability of the connection between the extracorporeal pulse generator 3 and the limiting seat 2, such as Figure 3As shown, in this embodiment, an adhesive layer 7 that can be adhered to the surface of a biological body is preferably provided at the bottom end of the shell 31, and a snap-fit ​​structure is used to relatively fix the limit seat 2 and the shell 31 inserted on the limit seat 2; in this way, when the extracorporeal pulse generator 3 is inserted on the limit seat 2, it can be adhered and fixed to the surface of the biological body at the same time, effectively improving the reliability of relative fixation between the extracorporeal pulse generator 3, the limit seat 2 and the surface of the biological body.

[0069] In an alternative embodiment, if Figure 5 , Fig.10 , Fig.12 , Fig.13 and Fig.14 As shown, the limit seat 2 includes a limit plate 21 and a plurality of first locking claws 22 formed on the limit plate 21; the first through hole 21a is opened on the limit plate 21, and the connecting section 12 is horizontally fixed on the limit plate 21; the first locking claw 22 includes a cantilever portion 211 and a claw portion 222 located on the outer side of the free end of the cantilever portion 211, and the claw portion 222 is provided with a first guide surface 2221; a first locking piece that cooperates and locks with each claw portion 222 is formed on the inner wall of the slot 311; when the extracorporeal pulse generator 3 is inserted into the limit seat 2, the first locking claw 22 cooperates and locks with the corresponding first locking piece to limit the removal of the extracorporeal pulse generator 3; that is, when the extracorporeal pulse generator 3 is inserted into place, the shell 31 and the limit seat 2 are snap-connected.

[0070] It can be understood that the first locking member is the first locking groove 312 or the first locking block 313, which is not limited thereto.

[0071] When the first locking piece is the first locking groove 312, if the extracorporeal pulse generator 3 is inserted in the direction close to the limit seat 2, the bottom of the slot 311 will squeeze the guide surface 2221 of the corresponding claw portion 222, causing the claw portion 222 to deflect inward until the claw portion 222 reaches the first locking groove 312; at this time, the claw portion 222 is reset and engaged with the corresponding first locking groove 312 to limit the removal of the extracorporeal pulse generator 3.

[0072] When the first locking piece is the first locking block 313, if the extracorporeal pulse generator 3 is inserted in the direction close to the limit seat 2, the first locking block 313 will squeeze the guide surface 2221 of the corresponding claw portion 222, causing the claw portion 222 to deflect inward until the claw portion 222 passes over the first locking block 313; at this time, the claw portion 222 is reset and locked with the corresponding first locking block 313 to limit the removal of the extracorporeal pulse generator 3.

[0073] In order to ensure the accuracy of the insertion position of the extracorporeal pulse generator 3, Fig.12 and Fig.13As shown, the limiting plate 21 needs to slide with the slot 311 in the plugging and unplugging direction; 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 relative to each other.

[0074] When the extracorporeal pulse generator 3 is inserted into the limiting seat 2, in order to ensure the sealing effect of the inner hole, the first elastic sealing pad 4 is bound to be compressed and deformed; in order to prevent the deformed first elastic sealing pad 4 from squeezing the circuit board 32 at the slot 311, it is necessary to form a groove on the inner wall of the slot 311 as shown in FIG. Fig. 9 The pressure plate 314 shown in the figure can not only apply deformation pressure to the first elastic sealing pad 4, but also support the circuit board 32 at the slot 311.

[0075] Since organisms produce sweat during daily activities, when the limiting plate 21 is thin, the sweat produced on the surface of the organism can easily flow along the first through hole 21a to the top of the limiting plate 21 and contact the connecting section 12, which not only easily causes the contacts on the connecting section 12 to oxidize and fail, but also easily causes circuit short circuit problems.

[0076] In view of this, if Figure 3 , Fig.13 , Fig.14 As shown, the present application opens a second sealing installation groove at the bottom of the limiting plate 21, and a second elastic sealing pad 6 for sealing the puncture wound is installed in the second sealing installation groove; the second elastic sealing pad 6 is configured to hold the implant segment 11 when the implant segment 11 is inserted into the second elastic sealing pad 6, so as to prevent sweat from seeping into the connecting segment 12 along the gap between the first through hole 21a and the implant segment 11.

[0077] In addition, sweat may also flow along the gap between the limiting seat 2 and the slot 311 to the connecting section 12 at the top of the limiting plate 21 ; embodiments for solving this problem include but are not limited to the following.

[0078] Embodiment 1

[0079] like Figure 5 , Fig.13 As shown, a circumferential sealing groove 21c is opened on the outer wall of the limit plate 21, and a sealing ring (not shown in the figure) is arranged in the circumferential sealing groove 21c. The sealing ring is used to prevent sweat from flowing along the gap between the limit seat 2 and the slot 311 to reach the connecting section 12 at the top of the limit plate 21.

[0080] Embodiment 2

[0081] like Figure 6 , Figure 7, the first elastic sealing pad 4 needs to cover the entire connecting section 12, and the first elastic sealing pad 4 is provided with a second through hole for the first conductive column to pass through; when the extracorporeal pulse generator 3 is inserted into 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 and contact and communicate with the corresponding connecting contact 143 on the connecting section 12; because the first elastic sealing pad 4 will be tightly attached to the limiting plate 21 after being deformed under pressure, sweat that reaches 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.

[0082] Of course, in order to ensure the accuracy of the installation position of the first elastic sealing pad 4, Figure 5 and Figure 6 As shown, a first sealing installation groove 21 b may be opened on the top surface of the limiting plate 21 ; at this time, the connecting section 12 is located at the bottom of the first sealing installation groove 21 b.

[0083] In addition, in order to ensure the connection stability between the first conductive column and the corresponding first connecting contact 143, a conductive sheet 23 that can completely fit with the bottom of each first conductive column can be provided on the limiting plate 21 in advance; after the connecting section 12 is fixed on the limiting plate 21, each connecting contact 143 can 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 can just be exposed by the second through hole; in this way, when the extracorporeal pulse generator 3 is installed on the limiting seat 2, the first conductive column can just pass through the second through hole and contact the conductive sheet 23.

[0084] It is worth mentioning that in the above-mentioned extracorporeal pulse generator 3, the shell 31 can be either an integrated structure or a split structure, which is not limited.

[0085] When the housing 31 is an integral structure, it is integrally injection-molded from insulating materials such as epoxy resin, polyurethane, or polysulfone.

[0086] When the housing 31 is a split structure, it is formed by the upper housing 31b and the lower housing 31a being connected (eg Fig.10 As shown); during docking, in order to ensure the docking accuracy of the two, a positioning column 315 can be set in one of the upper shell 31b and the lower shell 31a, and a positioning cylinder 316 that cooperates with the positioning column 315 can be set in the other; the docking accuracy of the upper shell 31b and the lower shell 31a is guaranteed by the cooperation between the positioning column 315 and the positioning cylinder 316; in addition, the two need to be relatively fixed after docking, and the relative fixing methods of the two include but are not limited to magnetic connection, snap connection and bolt connection. Based on the convenience of operation and connection reliability, the snap connection is preferably adopted in this embodiment. Specifically, as Fig.10 and Fig.11As shown, one of the upper shell 31b and the lower shell 31a is provided with a second locking claw 318, and the other is provided with a second locking slot 317; the second locking claw 318 cooperates with the second locking slot 317 to achieve a snap connection between the upper and lower shells.

[0087] In addition, in the above-mentioned extracorporeal pulse generator 3, the circuit board 32 needs to be powered to provide an electrical pulse signal to the electrode 1, and the power supply methods of the circuit board 32 include but are not limited to the following two.

[0088] The first power supply mode: the circuit board 32 is powered by the battery 33 in the housing 31 .

[0089] The second power supply mode: the circuit board 32 is powered by an electric energy converter. Specifically, the electric energy converter includes a receiving coil and a transmitting coil; the transmitting coil is located outside the housing 31 and is used to generate magnetic field energy; the receiving coil is located inside the housing 31 and is used to receive the magnetic field energy and convert the magnetic field energy into electric energy to power the circuit board 32.

[0090] It is understandable that the structure of the electrode 1 is varied, including but not limited to the following two embodiments.

[0091] Embodiment 1

[0092] The electrode 1 is manufactured based on a planar flexible circuit board (i.e., a thin film electrode), and the planar flexible circuit board has an electrode segment for forming an implantation segment 11 and a connection contact segment for forming a connection segment 12; the specific manufacturing steps of the electrode 1 include:

[0093] A1. A patterned conductive layer is provided on a planar flexible insulating substrate 13 to form a planar flexible circuit board having electrode segments and connecting contact segments.

[0094] like Fig.15 and Fig.17 As shown, the patterned conductive layer includes electrode contacts 141 located on the electrode segments, connection contacts 143 located on the connection contact segments, and conductive lines 142 for connecting the electrode contacts 141 with the corresponding connection contacts 143; wherein the electrode contacts 141 located at the same length position can cooperate to form the stimulation member 11a.

[0095] It is understandable that the flexible insulating substrate 13 is a single-layer material structure or a multi-layer material structure, which is not limited. The thickness of the flexible insulating substrate 13 is 100 nm to 300 μm.

[0096] When the flexible insulating substrate 13 is 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.

[0097] When the flexible insulating substrate 13 is a multi-layer material structure, it includes a top layer structure, a bottom layer structure and an intermediate layer structure, and can be manufactured by a stacked 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 layer (PET) or fluorinated ethylene propylene copolymer (FEP) or polyurethane (TPU), without limitation; the intermediate layer structure is a tow layer (i.e., formed by a plurality of longitudinal tows spaced apart in the transverse direction) or a woven mesh layer (i.e., formed by tows woven vertically and horizontally), and is made of various materials with high tensile strength such as silk, polypropylene, polyglycolic acid (PGA), metal, etc., without limitation; the setting of the tow layer or the woven mesh layer can effectively enhance the tensile strength of the flexible insulating substrate 13.

[0098] After the flexible insulating substrate 13 is prepared, it needs to be subjected to plasma activation treatment before the patterned conductive layer is set; the plasma activation treatment can effectively increase the adhesion of the flexible insulating substrate 13, thereby ensuring the firmness of the patterned conductive layer.

[0099] It is understandable that the configuration of the patterned conductive layer includes but is not limited to the following two methods:

[0100] The first method is to plate a layer of conductive material on the entire upper surface of the flexible insulating substrate 13; then, cover the conductive material with a first mask plate, and ablate and remove excess conductive material to obtain a final patterned conductive layer; the first mask plate is manufactured according to the design of the patterned conductive layer, so that the area of ​​the non-patterned conductive layer is exposed.

[0101] The second method is to cover the flexible insulating substrate 13 with a second mask plate having grooves corresponding to the pattern conductive layer; and spray-plating a conductive material on the grooved area of ​​the second mask plate to obtain a final pattern conductive layer.

[0102] The conductive material mentioned above is made of conductive materials such as copper, molybdenum or gold, which is not limited to this; the thickness of the pattern conductive layer is 120nm~180nm.

[0103] A2. Curl the flat flexible circuit board so that the edges of both sides of the flat flexible circuit board are butted together to form a columnar electrode with the patterned conductive layer on the outside.

[0104] The winding of the planar flexible circuit board can be completed with the help of various existing winding mechanisms such as a winding mandrel; the butt joints of the two sides of the planar flexible circuit board are welded by laser.

[0105] A3. Shield the contacts in the patterned conductive layer, and then apply an insulating coating to the rest of the columnar electrode to form an insulating coating layer (not shown in the figure) covering the conductive line 142; at this time, the columnar electrode segment is the implanted segment 11 of the electrode 1.

[0106] Furthermore, in order to protect the contacts of the patterned conductive layer, a conductive protective coating may be plated on the electrode contacts 141 and the connection contacts 143 ; the conductive protective coating includes but is not limited to conductive coatings with high stability such as polytetrafluoroethylene (PTFE) or parylene coating.

[0107] A4. Set a plurality of axial dividing lines on the connecting contact segment, and cut the connecting contact segment along the axial dividing lines to split the connecting contact segment into a plurality of fixed petals 121; each connecting contact 143 is located on a different fixed petal 121; bend each fixed petal 121 to form a preset angle with the electrode segment to form the connecting segment 12 of the electrode 1; at this point, the preparation of the electrode 1 is completed.

[0108] It is understandable that the insulating coating layer may be provided in advance between step A1 and step A2.

[0109] It is understandable that the electrode 1 is divided into an omnidirectional electrode and a directional electrode. As the name implies, an omnidirectional electrode refers to an electrode that can stimulate the target nerve 360 ​​degrees; a directional electrode refers to an electrode that stimulates a specific direction.

[0110] When the electrode 1 is a directional electrode manufactured based on a flat flexible circuit board, it is only necessary to ensure that the flat flexible circuit board has multiple electrode contacts 141 arranged at intervals at the same length position; in this way, when the flat flexible circuit board is rolled to form a columnar electrode 1, the electrode contacts 141 at the same length position can be distributed along the periphery of the electrode 1 to form a ring-shaped stimulation member 11a, thereby facilitating the stimulation needs in different directions. Since there is a gap between two adjacent electrode contacts 141, it is convenient to realize the layout of the conductive circuit 142, so the flat flexible circuit board is relatively easy to manufacture.

[0111] When the electrode 1 is an omnidirectional electrode manufactured based on a planar flexible circuit board, only one electrode contact 141 can be provided at each length position of the planar flexible circuit board, and the width of the electrode contact 141 needs to be consistent with the width of the planar flexible circuit board; in this way, when multiple electrode contacts 141 need to be provided on the planar flexible circuit board, there will inevitably be a problem that the conductive circuit 142 cannot be arranged (i.e., there will be a problem that the conductive circuit 142 is connected to multiple electrode contacts 141); in order to solve this problem, each electrode contact 141 can be numbered in sequence from far to near according to the position of the connection contact segment, that is, the electrode contact 141 farthest from the connection contact segment is defined as the first electrode contact; then, a serpentine wiring groove 141a (such as 141a) for the conductive circuit 142 to pass through is opened on each electrode contact 141 except the first electrode contact. Fig.15 and Fig.16As shown), this can avoid the situation where one conductive circuit 412 is connected to multiple electrode contacts 141 at the same time; because the serpentine wiring groove 141a will divide each electrode contact 141 except the first electrode contact into two parts; therefore, after the flat flexible circuit board is curled into a column, it is necessary to weld the electrode contacts 141 divided into two parts by the serpentine wiring groove 141a at the joint to form a stimulation member 11a, thereby ensuring that each stimulation member 11a can perform 360-degree omnidirectional stimulation.

[0112] Embodiment 2

[0113] The electrode 1 is manufactured based on a columnar flexible circuit board, and the columnar flexible circuit board has an electrode segment for forming an implantation segment 11 and a connection contact segment for forming a connection segment 12. The specific manufacturing steps of the electrode 1 include:

[0114] B1. A patterned conductive layer is provided on the hollow tubular flexible insulating substrate 13 to form a columnar flexible circuit board having electrode segments and connecting contact segments.

[0115] like Fig.18 and Fig. 20 As shown, the patterned conductive layer includes electrode contacts 141 located on the electrode segments, connection contacts 143 located on the connection contact segments, and conductive lines 142 for connecting the electrode contacts 141 with the corresponding connection contacts 143; wherein the electrode contacts 141 located at the same length position can cooperate to form the stimulation member 11a.

[0116] It is understandable that the flexible insulating substrate 13 is a single-layer material structure or a multi-layer material structure, which is not limited. The thickness of the flexible insulating substrate 13 is 100 nm to 300 μm.

[0117] When the flexible insulating substrate 13 is 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.

[0118] When the flexible insulating substrate 13 is a multi-layer material structure, it includes an inner tube, an outer tube and an intermediate tube, and can be manufactured by an alternating extrusion tube method; wherein the inner tube and the outer tube are made of various flexible insulating substrate materials such as polyimide (PI) or polyethylene terephthalate layer (PET) or fluorinated ethylene propylene copolymer (FEP) or polyurethane (TPU), without limitation; the intermediate tube is a braided mesh tube (i.e., formed by weaving bundles vertically and horizontally), and is made of various materials with high tensile strength such as silk, polypropylene, polyglycolic acid (PGA), metal, etc., without limitation; the setting of the braided mesh tube can effectively enhance the tensile strength of the flexible insulating substrate 13; of course, the inner tube can also be omitted to reduce the thickness of the flexible insulating substrate 13.

[0119] After the flexible insulating substrate 13 is prepared, its outer surface needs to be plasma activated before the pattern conductive layer is set. The plasma activation treatment can effectively increase the adhesion of the flexible insulating substrate 13, thereby ensuring the firmness of the pattern conductive layer.

[0120] It is understandable that the configuration of the patterned conductive layer includes but is not limited to the following two methods:

[0121] The first method is to plate a layer of conductive material on the entire upper surface of the flexible insulating substrate 13; then, a third mask plate is placed on the conductive material, and excess conductive material is ablated and removed to obtain a final patterned conductive layer; the third mask plate is a tubular structure manufactured according to the design of the patterned conductive layer, which can expose the area of ​​the non-patterned conductive layer.

[0122] The second method is to sleeve a fourth mask plate on the flexible insulating substrate 13, wherein the fourth mask plate has grooves corresponding to the pattern conductive layer; and spray a conductive material on the grooved area of ​​the fourth mask plate to obtain a final pattern conductive layer.

[0123] The conductive material mentioned above is made of conductive materials such as copper, molybdenum or gold, which is not limited; the thickness of the pattern conductive layer is 120nm~180nm.

[0124] B2. Mask the contacts in the patterned conductive layer, and then apply an insulating coating to the rest of the columnar flexible circuit board to form an insulating coating layer (not shown in the figure) covering the conductive line 142; at this time, the electrode segment of the columnar flexible circuit board is the implanted segment 11 of the electrode 1.

[0125] Furthermore, in order to protect the contacts of the patterned conductive layer, a conductive protective coating may be plated on the electrode contacts 141 and the connection contacts 143 ; the conductive protective coating includes but is not limited to conductive coatings with high stability such as polytetrafluoroethylene (PTFE) or parylene coating.

[0126] B3. Set a plurality of axial dividing lines on the connecting contact segment, and cut the connecting contact segment along the axial dividing lines to split the connecting contact segment into a plurality of fixed petals 121; each connecting contact 143 is located on a different fixed petal 121; bend each fixed petal 121 into a state at a preset angle with the electrode segment to form the connecting segment 12 of the electrode 1; at this point, the preparation of the electrode 1 is completed.

[0127] It is understandable that the electrode 1 is divided into an omnidirectional electrode and a directional electrode. As the name implies, an omnidirectional electrode refers to an electrode that can stimulate the target nerve 360 ​​degrees; a directional electrode refers to an electrode that stimulates a specific direction.

[0128] When the electrode 1 is a directional electrode manufactured based on a columnar flexible circuit board, it is only necessary to ensure that the columnar flexible circuit board has multiple electrode contacts 141 spaced apart in the circumferential direction at the same length position. At this time, each electrode contact 141 at the same length position constitutes a stimulation member 11a, so that the electrode contacts 141 at different directions of the stimulation member 11a can be used to achieve stimulation requirements in different directions. Since there is a gap between two adjacent electrode contacts 141, it is convenient to realize the layout of the conductive circuit 142, so the manufacture of the columnar flexible circuit board is relatively easy.

[0129] When the electrode 1 is an omnidirectional electrode manufactured based on a cylindrical flexible circuit board, the cylindrical flexible circuit board can only be provided with one electrode contact 141 as the stimulator 11a at each length position, and the electrode contact 141 is a ring-shaped structure; in this way, when it is necessary to provide multiple electrode contacts 141 on the cylindrical flexible circuit board, there will inevitably be a problem that the conductive circuit 142 cannot be laid out (i.e., there will be a problem that the conductive circuit 142 is connected to multiple electrode contacts 141); in order to solve this problem, each electrode contact 141 can be numbered in sequence from far to near according to the position of the connection contact segment, that is, the electrode contact 141 farthest from the connection contact segment is defined as the first electrode contact; then, a serpentine wiring groove 141a (such as Fig.18 and Fig.19 As shown), in this way, the omnidirectional stimulation requirement can be met while avoiding the situation where one conductive circuit 412 is connected to multiple electrode contacts 141 at the same time.

[0130] In summary, the neurostimulation device provided by the present invention can directly use the puncture needle 5 to guide the electrode 1 to the target position, making the implantation step simpler, more convenient and faster, which not only reduces the requirements for the operator, but also shortens the time required for the entire implantation process, greatly reducing the risk of wound infection; moreover, when the electrode 1 is implanted in place, the limit seat 2 can be directly pressed and pasted on the surface of the biological body to complete the stable fixation of the electrode 1 after implantation, avoiding the problem of axial displacement of the electrode 1 after the puncture needle 5 is pulled out; in addition, after the puncture needle 5 is pulled out, the first elastic sealing pad 4 on the limit seat 2 can The inner hole of the electrode 1 is sealed to prevent external contaminants from entering the organism through the inner hole of the electrode 1 and causing wound infection; finally, the present application eliminates the extension wire, and only needs to insert and fix the extracorporeal pulse generator 3 on the limit seat 2 to complete the electrical connection between the extracorporeal pulse generator 3 and the connecting section 12; at the same time, since the extracorporeal pulse generator 3 and / or the limit seat 2 can be adhered and fixed to the surface of the organism, and there is no interference from the extension wire, the neural stimulation device of the present application is not easily affected by the activities of the organism, effectively reducing the connection interruption problem caused by the activities of the organism, and ensuring the stability and effectiveness of neural stimulation. After the electrode 1 is implanted in place, the relative position of the electrode and the puncture needle can be locked before implantation into the body. Only by using ultrasound to guide the insertion position and insertion depth of the puncture needle, the implantation position and implantation depth of the electrode can be accurately controlled, effectively improving the accuracy of the electrode implantation position, and avoiding the deficiency of repeated punctures due to inaccurate electrode implantation position.

[0131] In summary, the present invention effectively overcomes various shortcomings of the prior art and has high industrial utilization value.

[0132] The above embodiments are merely illustrative of the principles and effects of the present invention, and are not intended to limit the present invention. Anyone familiar with the art may modify or alter the above embodiments without departing from the spirit and scope of the present invention. Therefore, all equivalent modifications or alterations made by a person of ordinary skill in the art without departing from the spirit and technical concept disclosed by the present invention shall still be covered by the claims of the present invention.

Claims

1. A nerve stimulation device, characterized in that: The invention 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; after the puncture needle (5) is withdrawn from the electrode (1), the extracorporeal pulse generator (3) is detachably mounted on the limiting seat (2), and the extracorporeal pulse generator (3) is electrically connected to the electrode (1) via the connecting section (12) on the limiting seat (2).

2. A nerve stimulation device according to claim 1, characterized in that: One end of the implantation section (11) away from the connection section (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 an inverted frustum shape as a whole.

6. A nerve stimulation device according to any one of claims 1 to 5, characterized in that: The extracorporeal pulse generator (3) comprises a housing (31) and a circuit board (32) for generating a pulse signal; the circuit board (32) is located inside the housing (31), and is provided with first conductive posts corresponding one-to-one to each connection contact (143) on the connection section (12); an end of the housing (31) close to the surface of the biological body is inserted into a limiting seat (2) so that the first conductive posts are connected to the corresponding connection contacts (143); an end of the housing (31) close to the surface of the biological body is detachably fixed to the surface of the biological body, and / or the housing (31) and the limiting 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 housing (31) close to the surface of the biological body, and the extracorporeal pulse generator (3) is inserted into the limiting seat (2) through the slot (311).

8. A nerve stimulation device according to claim 7, characterized in that: The limiting seat (2) comprises a limiting plate (21) and a plurality of first locking claws (22) formed on the limiting plate (21); the first through hole (21a) is provided on the limiting plate (21); a first locking piece cooperating with the first locking claw (22) is provided on the slot (311); when the extracorporeal pulse generator (3) is inserted into the limiting seat (2), the first locking claw (22) cooperates with and locks with the corresponding first locking piece to restrict 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: The limiting seat (2) is provided with a first elastic sealing pad (4) for sealing the inner hole of the electrode (1), and the first elastic sealing pad (4) is provided with a first introduction gap for the puncture needle (5) to pass through.

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) tightly 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 formed 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 a corresponding connection contact (143); a plurality of axial dividing lines are arranged 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 nerve stimulation device according to claim 13, characterized in that: The stimulation member (11a) comprises an electrode contact (141) which is a ring-shaped structure; the electrode contact (141) farthest from the connection 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 a 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 rolling a planar flexible circuit board.

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