A nerve stimulation device

Abstract

The present invention provides a neural stimulation device, comprising an electrode, a limiting seat, a puncture needle and an extracorporeal pulse generator detachably fixed 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 puncture needle to pass through; the puncture needle is pre-inserted on the implantation section through the first through hole to form an electrode puncture assembly; an axial notch is provided on the outer wall of the puncture needle, the axial notch enables the puncture needle to be withdrawn from the electrode without interference; when the extracorporeal pulse generator is fixed on the limiting seat, the extracorporeal pulse generator is electrically connected to the connection section on the limiting seat. The device of the present application advances the alignment and insertion steps of the electrode and the puncture needle to before implantation, and uses the puncture function of the puncture needle to directly guide the electrode to the target position; compared with the traditional implantation method of first inserting the puncture needle and then inserting the electrode into the organism along the inner hole of the puncture needle, the implantation steps of the present application are simpler, more convenient and easier to operate.

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: a hollow puncture needle is inserted into the target area in the body, and then the electrode is inserted into the body along the inner hole of the puncture needle until it reaches the target position; the puncture needle is then withdrawn, leaving the electrode in the body; then, the electrode is connected to the extracorporeal pulse generator using an extension wire; in this way, the electric pulse generated by the extracorporeal pulse generator can be transmitted to the electrode through the extension wire, and the electrode then transmits the electric pulse to the target nerve to achieve neurostimulation.

[0004] During the actual implantation process, it was found that due to the small inner hole of the puncture needle, the operator needs to spend more time and energy to insert the electrode into the inner hole of the puncture needle to complete the electrode implantation. The overall operation difficulty is relatively high, resulting in the puncture needle being retained in the body for a long time, greatly increasing the chance of wound infection. In addition, when the electrode is inserted along the inner hole of the puncture needle, it is also difficult to accurately locate the electrode position. It is very easy for the electrode to be implanted incorrectly and need to be re-punctured and implanted, which increases the burden on the organism. Summary of the invention

[0005] In view of the above shortcomings of the prior art, the purpose of the present invention is to provide a neural stimulation device, which pre-installs a puncture needle on the electrode before implantation, so as to utilize the puncture function of the puncture needle to guide the electrode directly to the target position; compared with the traditional implantation method of first inserting the puncture needle and then inserting the electrode into the organism along the inner hole of the puncture needle, the implantation steps of the neural stimulation device of the present application are simpler, more convenient, and easier to operate, which greatly shortens the time that the puncture needle remains in the organism during the electrode implantation process, thereby reducing the chance of wound infection.

[0006] To achieve the above-mentioned purpose and other related purposes, the present invention provides a neural stimulation device, comprising an electrode, a limiting seat, a puncture needle and an extracorporeal pulse generator detachably fixed on the limiting seat; the electrode comprises an implantation section and a connection section; the implantation section comprises at least one stimulator, and the connection section has a connection contact that is electrically connected to the stimulator; the connection section of the electrode is fixed on the limiting seat; the limiting seat is provided with a first through hole for the puncture needle to pass through; the puncture needle is inserted into the implantation section of the electrode through the first through hole to form an electrode puncture assembly; during the process of inserting the electrode puncture assembly into a biological body, the limiting seat moves along with it; an axial notch is provided on the outer wall of the puncture needle; the axial notch enables the puncture needle to be withdrawn from the electrode without interference; when the extracorporeal pulse generator is fixed on the limiting seat, the extracorporeal pulse generator is electrically connected to the connection section on the limiting seat. When in use, the electrode puncture assembly formed by the pre-assembly of the puncture needle and the electrode must first be inserted into the biological body, so as to use the puncture function of the puncture needle to guide the electrode directly to the target position. During this process, since the limit seat is fixedly connected to the connecting section of the electrode, the limit seat will also move along to gradually approach the surface of the biological 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 biological body; finally, the extracorporeal pulse generator is fixed on the limit seat so that the extracorporeal pulse generator is conductively 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. ; Due to the neurostimulation device of the present application, the alignment and insertion steps of the electrode and the puncture needle are advanced to before implantation, and the puncture function of the puncture needle is used to directly guide the electrode to the target position; compared with the traditional implantation method of first inserting the puncture needle and then inserting the electrode into the organism along the inner hole of the puncture needle, the implantation steps of the present application are simpler, more convenient, and easier to operate, which greatly shortens the retention time of the puncture needle in the organism to reduce the chance of wound infection; in addition, since the present application has completed the determination of the relative position of the electrode and the puncture needle before implantation, 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 of the electrode, effectively improving the accuracy of the electrode implantation position.

[0007] Preferably, the extracorporeal pulse generator includes a shell and a circuit board for generating a pulse signal; the circuit board is located in the shell, and the circuit board is provided with first conductive pins corresponding to each connection contact on the connection section; the end of the shell close to the surface of the organism is inserted and fixed on the limit seat so that the first conductive pin is connected to the corresponding connection contact; the limit seat and / or the shell can be detachably fixed on the surface of the organism. The present application eliminates the extension wire, and only needs to insert the shell of the extracorporeal pulse generator on the limit seat to achieve the conductive connection between the extracorporeal pulse generator and the electrode; in addition, since the extracorporeal pulse generator and the limit seat can be inserted and fixed together, and the extracorporeal pulse generator and / or the limit seat can also be fixed on the surface of the organism, the extracorporeal pulse generator, the limit seat and the surface of the organism can be relatively fixed after the electrode is implanted, thereby effectively reducing the interference of the organism's activities on the implanted neural stimulation device, avoiding the problems of stimulation interruption caused by the extension wire being pulled off and electrode displacement caused by pulling, and ensuring the stability and effectiveness of neural stimulation.

[0008] Preferably, a slot is provided at one end of the shell close to the surface of the biological body to expose the first conductive pin, 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 neural stimulation device after implantation.

[0009] Preferably, the limit seat includes a limit plate and a plurality of locking claws formed on the limit plate, and a locking block that cooperates with the locking claws is formed on the inner wall of the slot; when the extracorporeal pulse generator is inserted into the limit seat, the locking claws cooperate and lock with the corresponding locking blocks to limit the removal of the extracorporeal pulse generator.

[0010] Preferably, the limit plate is provided with a plurality of guide members, each of which cooperates to form a guide plug that slides with the slot; the accuracy of the installation position of the extracorporeal pulse generator is ensured by the cooperation between the guide plug and the slot.

[0011] Preferably, the connecting section is covered with a flexible insulating seat, and the flexible insulating seat is provided with second conductive pins corresponding to the connecting contacts on the connecting section; the connecting section is fixed to the limiting plate through the flexible insulating seat; when the extracorporeal pulse generator is inserted into the limiting seat, the first conductive pin of the extracorporeal pulse generator is electrically connected to the corresponding connecting contact through the second conductive pin. Since the flexible insulating seat can be deformed, when the extracorporeal pulse generator is installed on the limiting seat, the flexible insulating seat can be deformed so that the limiting plate, the connecting section, and the circuit board are all tightly fitted with the flexible insulating seat to achieve a sealing effect, thereby preventing sweat generated on the surface of the organism from penetrating between the connecting section, the flexible insulating seat and the circuit board, causing a short circuit problem.

[0012] Preferably, the limiting plate is provided with a second through hole for the implantation segment to pass through; the first through hole is a C-shaped hole, and the inner side wall of the C-shaped hole close to the central axis of the implantation segment is enclosed to form a first guide member; the first guide member and the puncture needle are slidably matched in the axial direction of the implantation segment to ensure that the puncture needle can be accurately sleeved outside the implantation segment of the electrode, and guide the puncture needle when it is withdrawn from the electrode, thereby improving the installation efficiency and removal efficiency of the puncture needle.

[0013] Preferably, the width of the axial notch gradually increases in the direction away from the puncture end of the puncture needle, and the minimum width of the axial notch is adapted to the root size of the first guide member; since there is always processing precision in the production of the puncture needle and the electrode (such as the difference between the actual shape of the product and the designed shape, etc.), the puncture needle and the electrode cannot cooperate smoothly (that is, the puncture needle is easily obstructed or stuck when the electrode is set, resulting in an increase in positive pressure); in order to ensure the smoothness of the cooperation between the two, the axial notch adopts a gradually widening axial notch whose width gradually increases in the direction away from the puncture end of the puncture needle, so as to reduce the risk of the puncture needle being obstructed, thereby reducing the difficulty of plugging and unplugging the puncture needle; in addition, since the minimum width of the axial notch is adapted to the root size of the first guide member, it is ensured that the puncture needle will not be obstructed by the root of the first guide member when plugging and unplugging; and since the minimum width of the axial notch is close to the puncture end of the puncture needle, when the puncture end is inserted into the biological tissue, only a small amount of biological tissue enters the puncture needle, thereby avoiding the problem of the puncture needle being blocked by the biological tissue.

[0014] Preferably, an elastic sealing pad for pressing the puncture wound is provided on the limiting seat, and an introduction gap is provided on the elastic sealing pad; by pressing the puncture wound with the elastic sealing pad, the risk of infection of the wound can be reduced.

[0015] Preferably, the connecting section is a connecting contact section of a planar flexible circuit board; the portion of the planar flexible circuit board other than the connecting contact section includes an electrode section and a transition section; the stimulator is an electrode ring sleeved on the electrode section, and the electrode section has a stimulator welded one-to-one with the electrode ring; the stimulator is connected to the corresponding connecting contact via a conductive circuit; the electrode section of the planar flexible circuit board is encapsulated and coated with a flexible insulating sleeve connected to each electrode ring, and the outer wall of each electrode ring protrudes from or is flush with the outer wall of the flexible insulating sleeve to achieve the application of electrical stimulation; since the electrode section of the planar flexible circuit board is wrapped by the flexible insulating sleeve, when the electrode section is implanted in biological tissue, the flexible insulating sleeve can protect the coating layer at the electrode section to prevent it from falling off during repeated bending and folding to cause short circuit or open circuit problems; at the same time, the flexible insulating sleeve can also enhance the anti-fracture ability of the electrode section to meet the long-term use requirements of the neural electrode.

[0016] Preferably, the electrode segment includes a strip-shaped base and an extension body for carrying each electrode contact; each extension body is formed on the same side or different sides of the length direction of the strip-shaped base; the extension body is welded with a corresponding electrode ring by slot filler welding or the extension body is bent into an arc-shaped portion that fits the inner wall of the electrode ring and then welded to the corresponding inner wall of the electrode ring to ensure the welding strength between the electrode ring and the corresponding electrode contact.

[0017] Preferably, the connecting section is a connecting contact section of a planar flexible circuit board; the portion of the planar flexible circuit board other than the connecting contact section includes an electrode section and a transition section; the electrode section includes a strip-shaped substrate and at least one extension body spaced apart along the length direction of the strip-shaped substrate, and the extension body carries at least one electrode contact; each extension body is formed on the same side or different sides of the length direction of the strip-shaped substrate, and each extension body is curled along a predetermined direction to form a ring-shaped stimulation piece; the strip-shaped substrate of the electrode section is encapsulated and coated with a flexible insulating sleeve connected to each stimulation piece, and the electrode contacts on each stimulation piece are exposed on the outer wall of the flexible insulating sleeve; since the stimulation piece is formed by curling the extension body on the electrode section, there is no need to additionally equip a conductive ring as a stimulation piece, thereby effectively reducing the manufacturing cost of the electrode.

[0018] Preferably, the extension body carries an electrode contact, and the layout area of ​​the electrode contact is consistent with the plane area of ​​the corresponding extension body; in this way, when the extension body is curled to form a ring-shaped stimulation piece, the electrode contact thereon is curled to form an omnidirectional electrode contact, thereby meeting the omnidirectional stimulation requirements.

[0019] Preferably, the extension body carries a plurality of electrode contacts, and the plurality of electrode contacts are distributed in an array; thus, when the extension body where the electrode contacts are located is curled to form a ring-shaped stimulation member, each electrode contact thereon can serve as a directional electrode contact for directional stimulation.

[0020] As described above, a nerve stimulation device of the present invention has at least the following beneficial effects:

[0021] The neural stimulation device provided by the present invention pre-installs the puncture needle on the electrode before implantation, so as to utilize the puncture function of the puncture needle to directly guide the electrode to the target position; compared with the traditional implantation method of first inserting the puncture needle and then inserting the electrode into the organism along the inner hole of the puncture needle, the implantation steps of the present application are simpler, more convenient, and easier to operate, which greatly shortens the retention time of the puncture needle in the organism, thereby reducing the chance of wound infection; in addition, since the present application has completed the determination of the relative position of the electrode and the puncture needle before implantation, 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 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.

[0022] Furthermore, 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 fixing 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

[0023] Figure 1 This is a state diagram of the neural stimulation device in the present invention before electrode implantation.

[0024] Figure 2 This is a state diagram of the neurostimulation device from a first-person perspective after the puncture needle is removed from the electrode.

[0025] Figure 3 This is a state diagram of the neurostimulation device from a second perspective after the puncture needle is withdrawn from the electrode (the adhesive layer is not shown).

[0026] Figure 4 FIG. 4 is a three-dimensional diagram of an electrode in one embodiment of the present invention.

[0027] Figure 5 This is a stereoscopic view of a flexible insulating seat installed on an electrode connecting section.

[0028] Figure 6 It is a three-dimensional diagram of the flexible insulating seat.

[0029] Figure 7 It is a three-dimensional diagram of the limit seat.

[0030] Figure 8 It is a top view of the limit seat.

[0031] Fig. 9 This is a top view of the assembled electrode, flexible insulating seat and limit seat.

[0032] Fig.10 for Fig. 9 AA section view.

[0033] Fig.11 Schematic diagram of the structure of the puncture needle.

[0034] Fig.12 Schematic diagram of the puncture needle pre-installed on the electrode.

[0035] Fig.13This is a three-dimensional image of an extracorporeal pulse generator (looking upward from the bottom).

[0036] Fig.14 This is a three-dimensional exploded view of the extracorporeal pulse generator.

[0037] Fig.15 It is a structural schematic diagram of a flat flexible circuit board.

[0038] Fig.16 This is a schematic diagram of the front layer structure of a flat flexible circuit board using a double-sided board.

[0039] Fig.17 This is a schematic diagram of the reverse layer when a flat flexible circuit board uses a double-sided board.

[0040] Fig.18 FIG. 1 is a diagram showing the welding state of a flat flexible circuit board and an electrode ring in one embodiment of the present invention.

[0041] Fig.19 FIG. 4 is a diagram showing the welding state of a flat flexible circuit board and an electrode ring in another embodiment of the present invention.

[0042] Fig. 20 FIG. 4 is a flow chart of manufacturing an electrode in one embodiment of the present invention.

[0043] Fig.21 FIG. 4 is a flow chart of manufacturing an electrode in another embodiment of the present invention.

[0044] Description of Reference Numerals

[0045] Electrode 1, implantation section 11, stimulation member 111, flexible insulating sleeve 112, extension section 12, connection section 13, limit seat 2, limit plate 21, first through hole 21a, second through hole 21b, placement groove 21c, locking claw 22, cantilever portion 221, claw portion 222, first guide surface 2221, guide member 23, first positioning column 24, first guide member 25, auxiliary support member 26, extracorporeal pulse generator 3, shell 31, lower shell 31a, upper shell 31b, slot 311, locking block 312, second guide surface 31 3, second positioning column 314, circuit board 32, first conductive pin 321, battery 33, flexible insulating seat 4, second conductive pin 4a, upper seat body 41, lower seat body 42, flexible belt 43, ear seat 44, sealing pad 5, adhesive layer 6, flat flexible circuit board 7, electrode segment 71, strip substrate 711, extension body 712, transition segment 72, connecting contact segment 73, flexible insulating base layer 74, electrode contact 751, connecting contact 752, conductive circuit 753, flexible insulating coating layer 75, puncture needle 8, axial notch 81. DETAILED DESCRIPTION

[0046] 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.

[0047] See also Figures 1 to 21 . 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.

[0048] 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 1; 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, it is necessary to first puncture the hollow puncture needle into the target area in the body under the guidance of ultrasound, and then insert the electrode into the body along the inner hole of the puncture needle; when the electrode is implanted in place, the puncture needle needs to be pulled out, and then the pulse generator is connected to the external part of the electrode 1 through an extended wire. During actual implantation and use, it was found that due to the small inner hole of the puncture needle, it was difficult for the operator to align the electrode and insert it into the puncture needle, which required a lot of time and effort; since it was difficult to align the electrode 1 and insert it into the puncture needle, the puncture needle was retained in the organism for a long time, greatly increasing the risk of wound infection; in addition, even if the electrode 1 could be successfully aligned and inserted into the inner hole of the puncture needle, the operator would need to spend a lot of effort to control the insertion depth of the electrode, and it was very easy for the electrode to not be inserted into place and the puncture needle and electrode insertion would need to be re-performed, increasing the burden on the organism.

[0049] In view of this, the present invention provides a nerve stimulation device, which can effectively reduce the difficulty and time of electrode implantation, and greatly shorten the time that the puncture needle is left in the body during the electrode implantation process, thereby reducing the chance of wound infection. For ease 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.

[0050] See also Figure 1 , Figure 2 , Figure 3 , Figure 4 , Figure 8 and Fig.11 The present application relates to a nerve stimulation device, comprising an electrode 1, a limiting seat 2, a puncture needle 8 and an extracorporeal pulse generator 3 detachably fixed on the limiting seat 2; the electrode 1 comprises an implantation section 11 and a connection section 13; wherein the implantation section 11 comprises at least one stimulating member 111, and the connection section 13 has a connection contact 752 which is electrically connected to each stimulating member 111; the implantation section 11 of the electrode 1 is arranged on the limiting seat 2, and the connection section 13 of the electrode 1 is fixed on the limiting seat 2 in a detachable or non-detachable manner; in this embodiment, as Figure 4 As shown, the implantation section 11 preferably adopts a columnar structure, and the electrode 1 applies electrical stimulation to the target nerve through the stimulating member 111 on the implantation section 11; the connecting section 13 is preferably in a flat plate shape to ensure that there is a sufficient connection area between the connecting section 13 and the limiting seat 2; during treatment, the stimulating member 111 in contact with the target nerve is energized, and the stimulating member 111 not in contact with the target nerve is not energized;

[0051] The limiting seat 2 is provided with a first through hole 21a for the puncture needle 8 to pass through; the puncture needle 8 is inserted into the implantation section 11 of the electrode 1 through the first through hole 21a to form an electrode puncture assembly; when the electrode puncture assembly is inserted into the biological body under the guidance of ultrasound, the limiting seat 2 moves along with it to approach the surface of the biological body; an axial notch 81 is provided on the outer wall of the puncture needle 8, and the axial notch 81 can avoid the transition part (i.e., the extension section 12) between the implantation section 11 and the connecting section 13, so that the puncture needle 8 can be withdrawn from the electrode 1 without interference;

[0052] When the extracorporeal pulse generator 3 is fixed on the limiting seat 2 , the extracorporeal pulse generator 3 is electrically connected to the connecting section 13 on the limiting seat 2 to transmit the electric pulse signal generated by the extracorporeal pulse generator 3 to the electrode 1 .

[0053] When in use, it is necessary to first insert the electrode puncture assembly formed by the puncture needle 8 and the electrode 1 pre-assembled into the biological body under ultrasound guidance, so as to use the puncture function of the puncture needle 8 to directly guide the electrode 1 to the target position. In this process, since the limit seat 2 is fixedly connected to the connecting section 13 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 on the surface of the biological body, and the puncture needle 8 can be pulled out along the first through hole 21a, so that the implanted section 11 of the electrode 1 continues to remain in the biological body; then, the extracorporeal pulse generator 3 is fixed on the limit seat 2, so that the extracorporeal pulse generator 3 and the connecting section 13 on the limit seat 2 are in contact with each other. The connecting section 13 is conductively connected; in this way, the electric pulse signal generated by the extracorporeal pulse generator 3 will be transmitted to the target position through the electrode 1 to complete the application of electrical stimulation; the neural stimulation device of the present application advances the alignment and insertion step of the electrode 1 and the puncture needle 8 to before implantation, so as to optimize the implantation method of the electrode 1, so that the electrode 1 can reach the target position conveniently and quickly under the puncture guidance of the puncture needle 8; compared with the traditional implantation method of first inserting the puncture needle 8 and then inserting the electrode 1 into the organism along the inner hole of the puncture needle 8, the implantation step of the present application is simpler and more convenient, which not only reduces the operating difficulty of the operator, but also greatly shortens the retention time of the puncture needle 8 in the organism and reduces the chance of wound infection.

[0054] In addition, in the traditional electrode implantation method, even if the electrode 1 can be successfully inserted into the inner hole of the puncture needle 8, the operator still needs to spend a lot of energy to control the insertion depth of the electrode 1. It is very easy for the electrode 1 to be implanted improperly and need to be re-implanted. This step has high requirements for the operator; while the present application has completed the determination of the relative position between the electrode 1 and the puncture needle 8 before implantation. It only needs to use ultrasound to guide the insertion position and insertion depth of the puncture needle 8 to accurately control the implantation position of the electrode 1, which not only reduces the requirements for the operator, but also effectively improves the accuracy of the implantation position of the electrode 1.

[0055] 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 111 on the implant segments 11, etc.) so as to expand the scope of application of the neurostimulation device, the connecting segment 13 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.

[0056] It can be understood that the implantation section 11 of the electrode 1 is arranged on the limiting seat 2 through the first through hole 21a, or the implantation section 11 of the electrode 1 is arranged on the limiting seat 2 through the second through hole 21b (such as Figure 8 As shown) is arranged on the limiting seat 2, and no limitation is made to this; in this embodiment, it is preferred to pass the implantation section 11 of the electrode 1 through the second through hole 21b (as shown) Figure 8As shown in the figure, the first through hole 21a is arranged on the limit seat 2. At this time, the first through hole 21a is a C-shaped hole, which is arranged in the outer circle of the second through hole 21b in a semi-enclosed form. In this way, it is only necessary to insert the puncture needle 8 into the first through hole 21a to ensure that the puncture needle 8 can be accurately sleeved outside the implantation section 11 of the electrode 1, thereby improving the installation efficiency of the puncture needle 8.

[0057] It is understandable that when the electrode 1 is implanted in place, in order to prevent the electrode 1 from being pulled and displaced, the limit seat 2 needs to be fixed on the surface of the organism. The fixing method includes but is not limited to pressing fixation (such as pressing fixation by a manipulator or a human hand) or gluing fixation or binding fixation. This is not limited. In this embodiment, the limit seat 2 is preferably glued and fixed on the surface of the organism to ensure the stability and convenience of fixation. In addition, the application eliminates the extension wire. It only needs to 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 13. At the same time, since the extracorporeal pulse generator 3, the limit seat 2 and the surface of the organism are relatively fixed, and there is no interference from the extension wire, the neural stimulation device of the application is not easily affected by the activities of the organism, effectively reducing the problems of electrode 1 displacement and connection interruption caused by the activities of the organism, and ensuring the stability and effectiveness of neural stimulation.

[0058] In a specific embodiment, Figures 8 to 10 As shown, the inner side wall of the C-shaped hole close to the axis of the implantation segment 11 encloses a first guide member 25; the first guide member 25 can enter the inner hole of the puncture needle 8 and slide with the puncture needle 8 in the axial direction of the implantation segment 11; with this arrangement, the puncture needle 8 can be quickly and stably inserted into the implantation segment 11 of the electrode 1 or pulled out of the electrode 1 under the guidance of the first guide member 25. During this process, the axial notch 81 avoids the root of the first guide member 25 to avoid interference with the puncture needle 8 during insertion and removal; in this embodiment, the root of the first guide member 25 refers to the connecting portion of the first guide member 25 and the limiting plate 12.

[0059] Since there is always processing precision in the production of the puncture needle 8 and the first guide member 25 (such as the difference between the actual shape of the product and the designed shape, etc.), the puncture needle 8 and the first guide member 25 cannot cooperate smoothly (that is, the puncture needle 8 is easily obstructed or stuck when it is sleeved on the first guide member 25, resulting in an increase in positive pressure); in order to ensure the smoothness of the cooperation between the two, the axial notch 81 adopts a gradually widening axial notch whose width gradually increases away from the puncture end of the puncture needle 8, so as to reduce the risk of the puncture needle 8 being obstructed, thereby reducing the difficulty of inserting and removing the puncture needle 8; in addition, the minimum width of the axial notch 81 is adapted to the root size of the first guide member 25, so as to ensure that the puncture needle 8 will not be obstructed by the root of the first guide member 25 when inserting and removing.

[0060] See also Figure 3 , Fig.13 and Fig.14 The extracorporeal pulse generator 3 involved in the present application includes a shell 31 that can be 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 first conductive pins 321 that correspond one-to-one to each connecting contact 752 on the connecting section 13; the first conductive pins 321 are exposed relative to the shell 31, so that when the shell 31 is mounted on the limit seat 2, the first conductive pins 321 can be connected to the corresponding connecting contacts 752.

[0061] 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.

[0062] When the shell 31 is inserted into the limiting seat 2, 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 method for relatively fixing the shell 31 and the limiting seat 2 includes but is not limited to various existing connection methods that can achieve relative fixation and release of fixation, such as bolt connection, snap connection, magnetic connection, etc., and no limitation is made to this; in this embodiment, 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, as Figure 2 and Figure 3 As shown, in this embodiment, an adhesive layer 6 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, the reliability of relative fixation between the extracorporeal pulse generator 3, the limit seat 2 and the surface of the biological body can be effectively improved.

[0063] 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:

[0064] The first plug-in matching mode: the limit 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 for exposing the first conductive pin 321, and the slot 311 is plug-fitted with the limit seat 2 acting as a plug;

[0065] The second plug-in matching method: a plug with an exposed first conductive pin 321 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 the slot on the limit seat 2.

[0066] 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.

[0067] In an alternative embodiment, if Figure 7 , Figure 8 and Fig.13 As shown, the limit seat 2 includes a limit plate 21 and a plurality of 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 13 is fixed to the top of the limit plate 21; the locking claw 22 includes a cantilever portion 211 and a claw portion 222 located outside the free end of the cantilever portion 211, and the claw portion 222 is provided with a first guide surface 2221; a locking block 312 that cooperates with each claw portion 222 to lock is formed on the inner wall of the slot 311; when the extracorporeal pulse generator 3 is moved to When inserted in the direction close to the limit seat 2, the locking block 312 on the inner wall 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 locking block 312 passes over the corresponding locking block 312; at this time, the claw portion 222 is reset and locked with the corresponding locking block 312 to limit the removal of the extracorporeal pulse generator 3; in this embodiment, the bottom of the slot 311 can be chamfered to form a second guide surface 313 that cooperates with the first guide surface 2221.

[0068] In order to ensure the accuracy of the insertion position of the extracorporeal pulse generator 3, Figure 7 As shown, a plurality of guide members 23 are formed on the limit plate 21, and each guide member 23 cooperates to form a guide plug that slides 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 guide plug cannot rotate relative to each other.

[0069] In addition, if Figure 7 As shown, the top surface of the guide member 23 is flush with the top surface of the locking claw 22 , and when the extracorporeal pulse generator 3 is inserted in place, the guide member 23 and the locking claw 22 can provide auxiliary support for the circuit board 32 at the slot 311 .

[0070] See also Figure 7 An auxiliary support member 26 is formed on the limiting plate 12 , and the top surface of the auxiliary support member 26 is preferably flush with the top surface of the guide member 23 to provide auxiliary support for the circuit board 32 exposed at the slot 311 .

[0071] 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 pass through the through holes to reach the top of the limiting plate 21 and contact the connecting section 13, which not only easily causes the contacts on the connecting section 13 to oxidize and fail, but also easily causes circuit short circuit problems.

[0072] In view of this, if Figure 5 As shown, the present application covers a flexible insulating seat 4 on the connecting section 13, and the flexible insulating seat 4 is provided with a second conductive pin 4a corresponding to each connecting contact 752 on the connecting section 13; the flexible insulating seat 4 is detachably fixed on the limiting plate 21; when the extracorporeal pulse generator 3 is inserted into the limiting seat 2, the first conductive pin 321 of the extracorporeal pulse generator 3 is electrically connected to the corresponding connecting contact 752 via the second conductive pin 4a; since the connecting section 13 is covered by the flexible insulating seat 4 and the flexible insulating seat 4 is easy to deform, when the extracorporeal pulse generator 3 is installed in place, the flexible insulating seat 4 can be deformed so that the limiting plate 21, the connecting section 13, and the circuit board 32 are all tightly fitted with the flexible insulating seat 4, so as to achieve the purpose of isolating the external environment, thereby preventing the sweat generated on the surface of the organism and the water vapor in the external environment from contacting the connecting section 13 and the circuit board 32, which is beneficial to the long-term normal operation of the neural stimulation device.

[0073] In some embodiments, the flexible insulating seat 4 and the connecting section 13 are an integrated structure; specifically, a flexible insulating material such as silicone or polyurethane is potted on the connecting section 13 to form a flexible insulating seat 4 covering the connecting section 13 and reserving a conductive hole, and then a conductive glue is potted in the conductive hole reserved on the flexible insulating seat 4 to form a second conductive pin 4a. The flexible insulating seat 4 can be fixed on the limiting plate 21 by gluing or the like.

[0074] like Figures 6 to 8 As shown, in another embodiment, the flexible insulating seat 4 includes an upper seat body 41, a lower seat body 42 and a flexible belt 43 connecting the upper seat body 41 and the lower seat body 42; the upper seat body 41 and the lower seat body 42 can be switched between an upper and lower overlapping state and an unfolded state through the flexible belt 43; the upper seat body 41 is provided with a second conductive pin 4a corresponding to each connection contact 752; during assembly, it is only necessary to insert the connecting section 13 between the overlapping upper seat body 41 and the lower seat body 42, so that each second conductive pin 4a is connected to the corresponding connection contact 752 in a one-to-one correspondence. In this embodiment, the upper seat body 41, the lower seat body 42 and the flexible belt 43 are made of flexible insulating materials such as polyurethane potting glue or silicone.

[0075] In order to ensure the accuracy of the placement of the flexible insulating seat 4, Figure 2 , Figure 5 and Figure 7 As shown, a plurality of ear seats 44 need to be formed on the side of the upper seat body 41 away from the flexible belt 43, and a positioning hole is provided on the ear seat 44; a first positioning column 24 matching the positioning hole on the ear seat 44 is provided on the limiting plate 21; and the accuracy of the placement position of the flexible insulating seat 4 is ensured by the plug-in fit between the first positioning column 24 and the positioning hole on the ear seat 44.

[0076] Furthermore, if Figure 8 and Fig. 9 As shown, a placement groove 21c for placing the flexible insulating seat 4 is provided on the limiting plate 21, and the placement position of the flexible insulating seat 4 is further determined by the placement groove 21c to ensure the accuracy of the placement position.

[0077] 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; when the shell 31 is an integrated structure, it is integrally injection-molded from insulating materials such as epoxy resin, polyurethane, or polysulfone; when the shell 31 is a split structure, it is formed by the upper shell 31b and the lower shell 31a being connected (such as Fig.12 As shown); during docking, in order to ensure the docking accuracy of the two, a second positioning column 314 can be set in one of the upper shell 31b and the lower shell 31a, and a positioning hole that cooperates with the second positioning column 314 can be set in the other; the docking accuracy of the upper shell 31b and the lower shell 31a is ensured by the cooperation between the second positioning column 314 and the positioning hole; 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.

[0078] 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. The power supply methods of the circuit board 32 include but are not limited to the following two:

[0079] The first power supply mode: the circuit board 32 is powered by the battery 33 in the housing 31 .

[0080] 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.

[0081] It is worth mentioning that in the above-mentioned puncture needle 8, due to the existence of the axial notch 81, when the puncture end of the puncture needle 8 is inserted into the biological body, part of the biological tissue will inevitably enter the puncture needle 8; in order to reduce the entry of biological tissue, the extension section 12 needs to be as thin as possible to ensure that the root size of the first guide member 25 is minimized; based on this, the electrode 1 in this embodiment is preferably manufactured based on a planar flexible circuit board 7 (i.e., a thin film electrode); the manufacturing process of the planar flexible circuit board 7 is relatively mature and belongs to the prior art, so it will not be described in detail.

[0082] like Figures 15 to 17As shown, the planar flexible circuit board 7 is divided into an electrode segment 71, a transition segment 72 and a connection contact segment 73 along its length direction; the planar flexible circuit board 7 includes a flexible insulating base layer 74, a patterned conductive layer and a flexible insulating coating layer 76 which are stacked; the patterned conductive layer includes an electrode contact 751 located on the electrode segment 71, a connection contact 752 located on the connection contact segment 73 and a conductive circuit 753 for connecting the electrode contact 751 with the corresponding connection contact 752; the flexible insulating coating layer 76 is used to cover the conductive circuit 753 in the patterned conductive layer to protect the conductive circuit 753; wherein, the transition segment 72 of the planar flexible circuit board 7 is an extension segment 12 of the electrode 1, and the connection contact segment 73 of the planar flexible circuit board 7 is a connection segment 13 of the electrode 1; the implantation segment 11 of the electrode 1 is formed on the basis of the electrode segment 71.

[0083] It is understandable that the material of the pattern conductive layer 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.

[0084] It is understood that the flexible insulating base layer 74 and the flexible insulating film layer 76 can be made of a base material such as polyimide (PI) or polyethylene terephthalate (PET) or polyurethane (TPU), and this is not limited. The thickness of the flexible insulating base layer 74 and the flexible insulating film layer 13 is 100nm~300μm.

[0085] It is worth mentioning that the flat flexible circuit board 7 can be a single-sided board (i.e., only one pattern conductive layer), a double-sided board (for details, see Fig.16 and Fig.17 , a patterned conductive layer is respectively arranged on the front and back sides of the flexible insulating base layer 74, so as to complete the routing of more conductive circuits 753 within a smaller width range) or a multilayer board (that is, there are multiple patterned conductive layers, formed by stacking multiple single-sided boards), and there is no limitation on this. The specific board form can be determined according to the number of electrode channels that need to be integrated; in this embodiment, the planar flexible circuit board 7 preferably adopts a double-sided board form to carry as many electrode channels as possible within a plane with limited width.

[0086] It is understandable that the implant segment 11 may be formed in the following ways, but is not limited to:

[0087] The first way of formation: Fig.21As shown, the electrode segment 71 is in a strip-like structure as a whole, and an electrode ring welded to each pricking electrode contact 751 is sleeved on the electrode segment 71, and the electrode ring is used as a stimulating member 111; then, the electrode segment 71 with the welded electrode ring is placed in a potting mold, and the whole is potted with various medical flexible potting glues such as polyurethane potting glue or silicone potting glue to form the implant segment 11 of the electrode 1; in this process, the potting glue will form a flexible insulating sleeve 112 that covers the electrode segment 71 and connects the electrode ring, and the outer wall of each electrode ring protrudes from or is flush with the outer wall of the flexible insulating sleeve 112 to facilitate the application of electrical stimulation.

[0088] The second formation method: Fig.18 and Fig.19 As shown, the electrode segment 71 includes a strip-shaped substrate 711 and an extension body 712 for carrying each electrode contact 751; each extension body 712 is formed on the same side or different sides of the length direction of the strip-shaped substrate; a stimulation piece 111 is sleeved on the electrode segment 71 and is welded to each extension body 712 to connect the electrode contact 751 on the extension body 712 with the corresponding stimulation piece 111, and the stimulation piece 111 is an electrode ring; the extension body 712 is welded to the corresponding electrode ring with a slot filler (such as Fig.19 or the extension body 712 is bent into an arc portion that fits the inner wall of the electrode ring and then welded to the corresponding inner wall of the electrode ring (as shown in FIG. Fig.18 As shown), to ensure the connection strength between the extension body 712 and the corresponding electrode ring; finally, the electrode segment 71 of the welded electrode ring is placed in a potting mold, and the whole is potted with various medical flexible potting glues such as polyurethane potting glue or silicone potting glue to form the implant segment 11 of the electrode 1; in this process, the potting glue will form a flexible insulating sleeve 112 that covers the electrode segment 71 and connects the electrode ring, and the outer wall of each electrode ring protrudes from or is flush with the outer wall of the flexible insulating sleeve 112 to facilitate the application of electrical stimulation.

[0089] The third way of formation: Fig. 20As shown, the electrode segment 71 includes a strip-shaped substrate 711 and an extension body 712 for carrying each electrode contact 751; each extension body 712 is formed on the same side or different sides of the length direction of the strip-shaped substrate; the extension body 712 on the electrode segment 71 is wound along a predetermined direction to form a ring-shaped stimulation piece 111; then, the electrode segment 71 after the extension body 712 is wound to form the stimulation piece 111 is placed in a potting mold, and the whole is potted with various medical flexible potting glues such as polyurethane potting glue or silicone potting glue to form the implant segment 11 of the electrode 1; in this process, the potting glue will form a flexible insulating sleeve 112 that covers the strip-shaped substrate 711 and connects the stimulation piece 111, and the outer wall of each stimulation piece 111 protrudes from or is flush with the outer wall of the flexible insulating sleeve 112 to facilitate the application of electrical stimulation. In order to prevent the stimulating member 111 formed by winding the extension body 712 from spreading out, the free end of the winding extension body 712 needs to be fixed to the root of the extension body 712 by gluing, welding or clamping to maintain the shape of the stimulating member 111 .

[0090] In the third formation method, the extension body 712 carries an electrode contact 751. When the extension body 712 is curled to form a ring-shaped stimulation piece 111, the electrode contact 751 on the extension body 712 can be curled together to form an omnidirectional stimulation piece; or, the extension body 712 carries a plurality of electrode contacts 751, and the plurality of electrode contacts 751 are distributed in an array. In this way, when the extension body 712 is rolled into a ring, each electrode contact 751 thereon can constitute a directional stimulation piece.

[0091] In order to reduce the risk of infection of the puncture wound, an elastic sealing pad 5 is provided on the limiting seat 2 to press the puncture wound, and an introduction gap is provided on the elastic sealing pad 5 for the electrode 1 and the puncture needle 8 to pass through; after the puncture needle 8 is withdrawn, the elastic sealing pad 5 will shrink and hold the electrode 1 tightly to prevent external impurities from contaminating the wound.

[0092] In summary, the neurostimulation device provided by the present invention pre-installs the puncture needle 8 on the electrode 1 before implantation, so as to utilize the puncture function of the puncture needle 8 to directly guide the electrode 1 to the target position; compared with the traditional implantation method of first inserting the puncture needle 8 and then inserting the electrode 1 into the organism along the inner hole of the puncture needle 8, the implantation steps of the present application are simpler, more convenient, and easier to operate, which greatly shortens the retention time of the puncture needle 8 in the organism, thereby reducing the chance of wound infection; in addition, since the relative position of the electrode 1 and the puncture needle 8 has been determined before implantation in the present application, it is only necessary to use ultrasound to guide the insertion position and insertion depth of the puncture needle 8 to accurately control the implantation position of the electrode 1, thereby effectively improving the accuracy of the electrode implantation position and avoiding the deficiency of repeated punctures due to inaccurate electrode implantation position; in addition, the present invention will The connecting section 13 of the electrode 1 is fixed together with the limiting seat 2 that can be pasted and fixed on the surface of the biological body, so that after the electrode 1 reaches the target position, the limiting 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; the entire fixing process is convenient and fast, and easy to implement; in addition, the present application eliminates the extension wire of the neural stimulation device, and only needs to insert and fix the extracorporeal pulse generator 3 on the limiting seat 2 to complete the electrical connection between the extracorporeal pulse generator 3 and the connecting section 13; because the extracorporeal pulse generator 3 and the limiting seat 2 are both 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 neural electrode displacement and connection interruption caused by the activities of the biological body, and ensuring the stability and effectiveness of neural stimulation.

[0093] In summary, the present invention effectively overcomes various shortcomings of the prior art and has high industrial utilization value.

[0094] 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), a limiting seat (2), a puncture needle (8), and an extracorporeal pulse generator (3) detachably fixed to the limiting seat (2); the electrode (1) comprises an implantation section (11) and a connection section (13); the implantation section (11) comprises at least one stimulating element (111), and the connection section (13) has a connection contact (752) electrically connected to the stimulating element (111); the connection section (13) of the electrode (1) is fixed to the limiting seat (2); The limiting seat (2) is provided with a first through hole (21a) for the puncture needle (8) to pass through; the puncture needle (8) is inserted into the implantation section (11) of the electrode (1) through the first through hole (21a) to form an electrode puncture assembly; during the process of inserting the electrode puncture assembly into a biological body, the limiting seat (2) moves along with it; an axial notch (81) is provided on the outer wall of the puncture needle (8); the axial notch (81) enables the puncture needle (8) to be withdrawn from the electrode (1) without interference; After the puncture needle (8) is withdrawn from the electrode (1), the extracorporeal pulse generator (3) is detachably fixed on the limiting seat (2), and the extracorporeal pulse generator (3) is electrically connected to the electrode (1) via the connecting section (13) on the limiting seat (2).

2. A nerve stimulation device according to claim 1, 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 pins (321) corresponding one-to-one to each connection contact (752) on the connection section (13); one end of the housing (31) close to the surface of the biological body is inserted and fixed on the limit seat (2) so that the first conductive pins (321) are connected to the corresponding connection contacts (752); the limit seat (2) and / or the housing (31) can be detachably fixed on the surface of the biological body.

3. A nerve stimulation device according to claim 2, characterized in that: A slot (311) for exposing the first conductive pin (321) 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).

4. A nerve stimulation device according to claim 3, characterized in that: The limiting seat (2) comprises a limiting plate (21) and a plurality of locking claws (22) formed on the limiting plate (21); the first through hole (21a) is provided on the limiting plate (21); a locking block (312) cooperating with the locking claw (22) is formed on the inner wall of the slot (311); when the extracorporeal pulse generator (3) is inserted into the limiting seat (2), the locking claw (22) cooperates with the corresponding locking block (312) to lock, so as to limit the removal of the extracorporeal pulse generator (3).

5. A nerve stimulation device according to claim 4, characterized in that: The limiting plate (21) is provided with a plurality of guide members (23), and each guide member (23) cooperates to form a guide plug that is slidably matched with the slot (311).

6. A nerve stimulation device according to claim 4 or 5, characterized in that: The connecting section (13) is covered with a flexible insulating seat (4), and the flexible insulating seat (4) is provided with second conductive pins (4a) corresponding one-to-one to each connecting contact (752) on the connecting section (13); the connecting section (13) is fixed to the limiting plate (21) through the flexible insulating seat (4); when the extracorporeal pulse generator (3) is inserted into the limiting seat (2), the first conductive pin (321) of the extracorporeal pulse generator (3) is electrically connected to the corresponding connecting contact (752) via the second conductive pin (4a).

7. A nerve stimulation device according to any one of claims 1 to 5, characterized in that: The limiting seat (2) is provided with a second through hole (21b) for the implantation section (11) to pass through; the first through hole (21a) is a C-shaped hole, and the inner side wall of the C-shaped hole close to the central axis of the implantation section is surrounded to form a first guide member (25); the first guide member (25) and the puncture needle (8) are slidably matched in the axial direction of the implantation section (11).

8. A nerve stimulation device according to claim 7, characterized in that: The width of the axial notch (81) gradually increases in a direction away from the puncture end of the puncture needle, and the minimum width of the axial notch (81) is matched with the root size of the first guide member (25).

9. A nerve stimulation device according to claim 1, characterized in that: The limiting seat (2) is provided with an elastic sealing pad (5) for pressing the puncture wound, and the elastic sealing pad (5) is provided with an introduction gap.

10. A nerve stimulation device according to claim 1, characterized in that: The connecting section (13) is a connecting contact section (73) of the planar flexible circuit board (7); the part of the planar flexible circuit board (7) other than the connecting contact section (73) comprises an electrode section (71) and a transition section (72); the stimulating element (111) is an electrode ring sleeved on the electrode section (71), and the electrode section (71) has electrode contacts (751) welded one-to-one with the electrode rings; the electrode contacts (751) are connected to the corresponding connecting contacts (752) via conductive lines (753); the electrode section (71) of the planar flexible circuit board (7) is encapsulated and coated with a flexible insulating sleeve (112) connected to each electrode ring, and the outer wall of each electrode ring protrudes from or is flush with the outer wall of the flexible insulating sleeve (112) to achieve the application of electrical stimulation.

11. A nerve stimulation device according to claim 10, characterized in that: The electrode segment (71) comprises a strip-shaped substrate (711) and an extension body (712) for carrying each electrode contact (751); each extension body (712) is formed on the same side or different sides of the length direction of the strip-shaped substrate; the extension body (712) is welded with a corresponding electrode ring by slot filler welding, or the extension body (712) is bent into an arc-shaped portion that fits the inner wall of the electrode ring and then welded to the inner wall of the corresponding electrode ring.

12. A nerve stimulation device according to claim 1, characterized in that: The connecting section (13) is a connecting contact section (73) of a planar flexible circuit board (7); the portion of the planar flexible circuit board (7) other than the connecting contact section (73) comprises an electrode section (71) and a transition section (72); the electrode section (71) comprises a strip-shaped substrate (711) and at least one extension body (712) arranged at intervals along the length direction of the strip-shaped substrate, and the extension body (712) carries at least one electrode contact (751); each extension body (712) is formed on the same side or different sides of the length direction of the strip-shaped substrate, and each extension body (712) is curled along a predetermined direction to form an annular stimulating member (111); the strip-shaped substrate (711) of the electrode section (71) is encapsulated and coated with a flexible insulating sleeve (112) connected to each stimulating member (111), and the electrode contact (751) on each stimulating member (111) is exposed on the outer wall of the flexible insulating sleeve (112).

13. A nerve stimulation device according to claim 12, characterized in that: The extension body (712) carries an electrode contact (751), and the layout area of ​​the electrode contact (751) is consistent with the plane area of ​​the corresponding extension body (712).

14. A nerve stimulation device according to claim 12, characterized in that: The extension body (712) carries a plurality of electrode contacts (751), and the plurality of electrode contacts (751) are distributed in an array.

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