Implantable tibial nerve stimulation device and system

Abstract

This invention provides an implantable tibial nerve stimulation device and system, comprising a connected stimulator, a connector, and a stimulation electrode, wherein the stimulation electrode is collinear with the symmetrical center line of the stimulator; the stimulator includes a housing, a circuit board for generating stimulation pulses, and a feedthrough, wherein the housing is connected to the feedthrough and forms a sealed cavity for accommodating the circuit board, and the circuit board and the feedthrough are electrically connected; one side of the connector is fixed to the feedthrough, and the other side of the connector is fixed to the stimulation electrode, and the connector has a through hole for a wire from the stimulation electrode to pass through, the wire being connected to the feedthrough. The nerve stimulator of this invention is easy to implant, and the strip-shaped stimulation electrode makes it easier to contact the patient's tibial nerve, is more suitable for movement with the patient's ankle, and improves the stimulation effect.

Description

Technical Field

[0001] This utility model relates to the field of nerve stimulation technology, and in particular to an implantable tibial nerve stimulation device and stimulation system. Background Technology

[0002] Overactive bladder (OAB) is a bladder disorder characterized by an urgent and sudden urge to urinate. Typical symptoms include urinary frequency and urgency, bladder spasms, and urinary leakage. Possible causes of OAB include neurological disorders, diabetes, acute urinary tract infections, and bladder lesions (such as tumors or bladder stones).

[0003] The main methods currently available for treating overactive bladder (OAB) include sacral nerve modulation techniques, transcutaneous nerve stimulation, transcutaneous tibial nerve modulation, and implantable tibial nerve modulation.

[0004] Sacral neuromodulation (SNM) is an effective treatment for various lower urinary tract dysfunctions and is becoming increasingly popular in China. This therapy uses an implantable neurostimulator and electrodes. The electrodes are placed near the sacral nerve, and the neurostimulator is placed in a subcutaneous pouch in the lower back. By stimulating the sacral nerve, it modulates the nerve reflexes related to urination and defecation in the bladder, colon, sphincter, and pelvic floor, restoring balance to abnormal nerve reflexes and effectively controlling the symptoms of urinary and defecation dysfunction. Currently, sacral neuromodulation is relatively expensive, and complications such as pain at the implantation site (the patient's back), difficulty in independent leg movement, loss of efficacy, and electrode infection can occur.

[0005] Tibial nerve stimulation (TNS) is an innovative treatment for overactive bladder (OAB). This method involves implanting a tibial nerve stimulator to stimulate the tibial nerve in the leg, thereby inhibiting bladder movement and treating problems such as urinary frequency and incontinence caused by OAB. However, due to limitations in implantation location, implantable tibial nerve stimulators need to be smaller than stimulators used in other locations to avoid causing inconvenience to patients due to excessive size.

[0006] Therefore, it is necessary to develop an easily implantable tibial nerve electrical stimulation device. Utility Model Content

[0007] The purpose of this invention is to provide an implantable tibial nerve stimulation device and system, which is elongated, small in size, easy to implant, and can improve the patient's treatment experience.

[0008] This invention provides an implantable tibial nerve stimulation device, which includes a connected stimulator, a connector, and a stimulation electrode, wherein the stimulation electrode is collinear with the symmetrical center line of the stimulator. The stimulator includes a housing, a circuit board for generating stimulation pulses, and a feedthrough. The housing is connected to the feedthrough and forms a sealed cavity for accommodating the circuit board. The circuit board and the feedthrough are electrically connected. One side of the connector is fixed to the feedthrough, and the other side of the connector is fixed to the stimulation electrode. The connector has a through hole for a wire in the stimulation electrode to pass through, and the wire is connected to the feedthrough.

[0009] Optionally, the stimulator is a flat cuboid structure, and the two long sides of the stimulator in the width direction are arc surfaces.

[0010] Optionally, the thickness of the stimulator is 3-4.5 mm and the width is 9-12 mm; the total length of the implantable tibial nerve stimulation device is 20-22 mm.

[0011] Optionally, the feedthrough is provided with a guide post on the side facing the connector, and the connector is provided with a guide hole for the guide post to extend into; and / or, the feedthrough is welded to the housing via a flange.

[0012] Optionally, the feedthrough has a protruding guide platform on the side facing the stimulator, and the electrode terminals of the feedthrough pass through the guide platform.

[0013] Optionally, the guide platform is provided with a groove, and the feed-through electrode terminal is located in the groove.

[0014] Optionally, the feed passage is welded to the housing via a flange.

[0015] Optionally, the feedthrough is provided with an annular groove, and one side of the connector has an annular protrusion, which is confined within the annular groove.

[0016] Optionally, the housing includes at least one of the following: 1) the housing is a cuboid and all edges of the cuboid are arc-shaped; 2) The inner wall of the housing is provided with a groove for supporting the circuit board; 3) The material of the shell is ceramic.

[0017] Optionally, the stimulation electrode includes a body and a plurality of electrode contacts disposed on the body and flush with the surface of the body, the wire being disposed in the body and connected to the electrode contacts; the electrode contacts are formed by columnar electrodes or sheet electrodes.

[0018] Optionally, the end of the stimulation electrode is provided with a positioning hole for suturing and fixing; or, the through hole is filled with sealant.

[0019] This utility model also provides an implantable nerve stimulation system, which includes: a programmable controller, a wireless power supply device, and an implantable tibial nerve stimulation device as described in any of the above claims. The circuit board is provided with a power receiving coil, and the wireless power supply device is provided with a power transmitting coil that matches the power receiving coil.

[0020] The implantable tibial nerve stimulation device and system of this invention have the following beneficial effects: The stimulation electrodes are collinear with the symmetrical center line of the stimulator, thus making the tibial nerve stimulation device a symmetrical structure. Its overall shape is elongated, with a stacked linear structure extending from the stimulator to the stimulation electrodes, facilitating implantation. The strip-shaped stimulation electrodes are also more likely to contact the patient's tibial nerve and are more suitable for movement with the patient's ankle, improving the stimulation effect. The stimulator achieves both electrical and stable mechanical connections with the stimulation electrodes through feedthroughs and connectors, facilitating assembly and production. The implantable nerve stimulation system of this invention enables wireless power supply to the stimulator, eliminating the need for batteries, further reducing its size, making it easier to implant and more readily corresponding to the tibial nerve. Attached Figure Description

[0021] Figure 1 The diagram shown is an exploded view of an embodiment of the implantable tibial nerve stimulation device of this utility model. Figure 2 Shown as a feedthrough side view; Figure 3 Another axonometric view of the feedthrough is shown; Figure 4 A diagram showing an embodiment of the connector; Figure 5 A diagram showing one embodiment of the stimulating electrode is presented.

[0022] In the diagram, 1 is the housing; 2 is the circuit board; 3 is the feedthrough; 4 is the connector; 5 is the stimulation electrode; 6 is the flange; 301 is the annular groove; 302 is the guide post; 303 is the electrode terminal; 304 is the guide platform; 401 is the through hole; 402 is the guide hole; 403 is the annular protrusion; 501 is the wire; 502 is the columnar electrode; 503 is the positioning hole; 502a is the negative electrode; and 502b is the positive electrode. Detailed Implementation

[0023] To make the objectives, technical solutions, and advantages of the embodiments of this utility model clearer, the technical solutions in the embodiments of this utility model will be clearly and completely described below. Obviously, the described embodiments are only some embodiments of this utility model, not all embodiments. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model. Unless otherwise defined, the technical or scientific terms used herein should have the ordinary meaning understood by those skilled in the art to which this utility model pertains. The terms "comprising" and similar expressions used herein mean that the element or object preceding the word covers the element or object listed following the word and its equivalents, but does not exclude other elements or objects.

[0024] Currently, the main methods available for treating overactive bladder (OAB) include sacral nerve modulation, percutaneous tibial nerve modulation, and implantable tibial nerve modulation. Sacral nerve modulation involves implanting a nerve stimulator in the patient's back, a location prone to various complications. Percutaneous tibial nerve modulation is a non-invasive treatment that uses high-voltage current for stimulation. However, because the energy is conducted through the skin to the tibial nerve, it attenuates significantly during transmission, requiring a higher output energy from the device. This results in slightly less patient comfort and potential unknown damage to surrounding cells. Implantable tibial nerve modulation primarily utilizes an electrode-compatible stimulator shell, demanding high standards in electrode design and manufacturing. It is typically implanted in the ankle to stimulate the tibial nerve, significantly impacting patient mobility and preventing strenuous activities such as jumping.

[0025] The tibial nerve is one of the most important mixed nerves in the lower limbs of the human body. It is one of the two terminal branches of the sciatic nerve. It branches off from the sciatic nerve above the popliteal fossa (behind the knee) and descends along the deep fascia of the posterior calf, passing between the soleus and tibialis posterior muscles. It enters the sole of the foot behind the medial malleolus and divides into the medial plantar nerve and the lateral plantar nerve.

[0026] One embodiment of this utility model provides an implantable tibial nerve stimulation device, see [link to embodiment]. Figure 1As shown, it includes a connected stimulator, a connector 4, and a stimulating electrode 5. The stimulating electrode 5 is collinear with the symmetrical center line of the stimulator. In this embodiment, the stimulating electrode 5 is elongated. The symmetrical structure facilitates manufacturing and implantation, and patients adapt easily after implantation, reducing foreign body rejection and complications. Specifically, the stimulator includes a housing 1, a circuit board 2 for generating stimulation pulses, and a feedthrough 3. The housing 1 is connected to the feedthrough 3 and forms a sealed cavity for accommodating the circuit board 2. The circuit board 2 and the feedthrough 3 are electrically connected. One side of the connector 4 is fixed to the feedthrough 3, and the other side of the connector 4 is fixed to the stimulating electrode 5. The connector 4 has a through hole for the wire 501 in the stimulating electrode 5 to pass through. The wire 501 is connected to the feedthrough 3, thereby realizing the conduction between the circuit board and the stimulating electrode and realizing electrical stimulation.

[0027] In this embodiment, the stimulator is electrically connected to the stimulation electrode 5 via the feedthrough 3 and mechanically connected to the stimulation electrode 5 via the connector 4. The housing 1, feedthrough 3, and connector 4 are sequentially connected to form a stacked structure. The through-hole of the connector 4 ensures that the stimulation electrode 5 can be located on the symmetrical center line of the housing 1, which facilitates production and assembly to form an elongated structure. In this embodiment, the circuit board 2 is sealed in the sealed cavity formed by the housing 1 and the feedthrough 3, so that the size of the stimulator can be minimized. The circuit board 2 is provided with various circuit elements, which can be configured to generate DC pulses or stimulation signals, which are transmitted to the tibial nerve through the stimulation electrode. This further makes the stimulator a flat structure, which is easier to implant. In this embodiment, the stimulation device is basically elongated and can be implanted in the lower leg near the ankle bone. The stimulation electrodes can be distributed along the tibial nerve. If the end of the electrode can be fixed closer to the tibial nerve, electrical stimulation can be provided to the tibial nerve on the back of the lower leg to improve the stimulation effect. On the other hand, the elongated stimulation electrode is more flexible than the existing disc-shaped stimulation electrode, which makes it easier to extend and increase the multi-point stimulation contact with the tibial nerve along its length without affecting the patient's jumping movement.

[0028] The aforementioned circuit board 2 mainly integrates a power supply, stimulation circuit, communication circuit, and control circuit. This specification does not limit the circuit components on the circuit board; it only needs to be able to communicate with an external programmable device and generate stimulation pulses, as required by the functions of an in vivo stimulator. In this embodiment, the power supply and circuit board 2 can be stacked in a direction perpendicular to the symmetrical center line of the stimulator, gradually reducing the length of the housing; the power supply can be a wireless charging power supply. In another embodiment, to reduce the size of the stimulator, the circuit board 2 only has a power receiving coil that can accept wireless power. The power receiving coil eliminates the need for a power supply inside the stimulator; only an externally worn power device capable of wireless charging is required. To facilitate wireless charging alignment, in one embodiment, redundant coils are provided on the circuit board. These redundant coils can be used for impedance detection with the external charging device to achieve better coil alignment.

[0029] To facilitate implantation and improve post-implantation comfort, in one embodiment, the stimulator is a flat rectangular structure with two curved sides along its width. The flat shape allows the stimulator to reside solely within the skin tissue during implantation, facilitating external charging and control. The curved surfaces reduce friction between the stimulator and internal tissues, minimizing the feeling of a foreign body and further reducing the incidence of complications. The stimulation device, consisting of the flat stimulator and the stimulation electrode 5, has an overall elongated structure with a flat tip, making it easier to implant. Only the stimulator needs to be placed on the skin surface; the stimulation electrode can be implanted into the body using an implantation sheath, aligning it with the tibial nerve's pathway, thus facilitating nerve stimulation and improving the stimulation effect. In one specific embodiment, the stimulator's thickness is 3–4.5 mm (e.g., 3.5 mm–4 mm); its width is 9–12 mm; and the total length of the implantable tibial nerve stimulation device is 20–22 mm.

[0030] In one embodiment, see Figure 2 and Figure 4 As shown, a guide post 302 is provided on the side of the feedthrough 3 facing the connector 4, and a guide hole 402 is provided on the connector 4 for the guide post 302 to extend into. In this embodiment, the setting of the guide hole 402 and the guide post 302 facilitates the quick assembly of the connector 4 and the feedthrough 3 and facilitates the adhesive bonding between the two; further ensuring that the wire 501 on the stimulation electrode 5 can be aligned and connected with the electrode terminal 303 on the feedthrough after passing through the connector 4.

[0031] To facilitate the fixed connection between the feedthrough 3 and the connector 4, in one embodiment, the feedthrough 3 is provided with an annular groove 301, and one side of the connector 4 has an annular protrusion 403. The annular protrusion 403 is confined in the annular groove 301. The cooperation between the annular protrusion 403 and the annular groove 301 facilitates the guiding assembly of the feedthrough 3 and the connector 4, and also facilitates the injection of sealant, increases the contact area between the feedthrough 3 and the connector 4, provides the stability of the adhesive, and improves water resistance, preventing tissue fluid from entering and eroding the aforementioned wires and electrode terminals after implantation.

[0032] In this embodiment, the assembly of feedthrough 3 and connector 4 can be achieved through the cooperation of guide post 302 and guide hole 402, annular protrusion 403 and annular groove 301, using multiple positioning guidance to improve the collinear design of the symmetry center line of the stimulator and the stimulating electrode 5, thereby improving the symmetry of the tibial nerve stimulation device and making it easier to implant and use.

[0033] In one embodiment, see Figure 3 As shown, the feedthrough 3 has a protruding guide platform 304 on the side facing the housing 1. The electrode terminal 303 of the feedthrough 3 passes through the guide platform 304. The guide platform 304 facilitates the assembly and positioning of the feedthrough 3 and the flange 6. The guide platform 304 can be embedded in the flange 6 for easy welding and fixing. The guide platform 304 has a groove, in which the electrode terminal 303 of the feedthrough is located. The presence of the groove facilitates the connection of the electrode terminal 303 to the circuit board, further shortening the connection distance between the circuit board and the feedthrough and reducing the size of the stimulator. In a specific embodiment, the feedthrough 3 is welded to the housing 1 through the flange 6. Welding grooves are provided on both sides of the flange 6, allowing the end face of the housing 1 and the guide platform 304 to fully contact the welding grooves, improving the stability and sealing of the weld, and ensuring that the circuit board 2 is placed in a sealed manner.

[0034] In one embodiment, the aforementioned housing 1 is a cuboid with all edges curved. This curved design improves post-implantation comfort, reduces friction between the housing and the patient's internal tissues, and minimizes complications. Specifically, both long sides of the housing are curved along its length (the direction aligned with the extension direction of the stimulating electrode). The inner wall of the housing 1 has grooves for supporting the circuit board 2, which support and limit the circuit board 2, improving its stability. Since the stimulator is implanted near the patient's ankle or lower leg, a location with frequent and significant movement, it is prone to vibration. To prevent the circuit board from malfunctioning due to vibration, experiencing unstable stimulation output, or disconnecting from the electrode terminals on the feedthrough, this embodiment provides grooves on opposite inner walls of the housing 1 to limit and support the circuit board 2, preventing spatial displacement between the circuit board 2 and the housing 1.

[0035] Specifically, the material of the aforementioned shell 1 is ceramic. The internal space of the shell 1 has a dimension of 3-4 mm in the thickness direction of the stimulation device and a dimension of 9-10 mm in the width direction of the stimulation device. Based on this, the internal space is relatively small. The aforementioned circuit board 2 is installed inside the shell 1. In a preferred embodiment, the aforementioned circuit board 2 only has a power receiving coil that can accept wireless power supply, further reducing the overall size of the stimulator. The shell 1 can be formed by 3D printing, and its implantation position can be simulated in three dimensions to make it more ergonomic, so that it can be easily integrated into the body tissue after implantation and move with the tissue, avoiding complications caused by stimulating the tissue. For example, the curvature of one side of it is consistent with the arc of the movement trajectory of the muscles in the body. To facilitate fixation after implantation, in one embodiment, the ceramic shell 1 is provided with positioning holes or positioning grooves for easy implantation fixation. Alternatively, the shell 1 may have growth pores for tissue growth, such as growth pores filled with photocurable hydrogel, allowing the tibia or in vivo tissue to extend into the growth pores and grow, achieving "bio-electronic symbiotic fixation." In yet another embodiment, the shell 1 is provided with protrusions, grooves, or an electromagnetic positioning structure (such as an electromagnetic positioning coil or electromagnetic positioning block on a circuit board) to facilitate mechanical or electromagnetic guidance and alignment with an external wireless charging device.

[0036] In one embodiment, see Figure 1 and Figure 5 As shown, the stimulation electrode 5 includes a main body and multiple electrode contacts (in this embodiment, columnar electrodes 502 constitute the electrode contacts) placed on the main body and flush with the surface of the main body. A wire 501 is placed in the main body and connected to the electrode contacts. In this embodiment, the main body can be a tubular component. The outer diameter of the columnar electrodes 502 is the same as or approximately the same as the outer diameter of the tubular component. Multiple tubular components and multiple columnar electrodes are connected in series. Wires are threaded through the tubular component and welded to the inner surface of the columnar electrodes for conductivity and fixation. The size of the columnar electrodes is set to be consistent with the main body, making the outer surface of the stimulation electrode a smooth surface without unevenness or irregularities, facilitating implantation, reducing the foreign body sensation after implantation, and reducing post-implantation complications, such as inflammation caused by irritation of internal tissues due to unevenness.

[0037] The electrode contacts described above can be formed using either columnar electrodes or sheet electrodes; that is, the structure of the electrode contacts themselves is not limited. In one embodiment, the number of columnar electrodes is four, which can provide multi-point stimulation along the course of the tibial nerve, thereby improving the stimulation effect. Furthermore, the arrangement of multiple columnar electrodes can provide redundant stimulation, avoiding the problem of the columnar electrodes themselves failing to provide electrical stimulation to the tibial nerve. To improve stimulation performance, in one embodiment, the spacing between the columnar electrodes is 3.5–4.5 mm, the same as the spacing between the columnar electrode pieces.

[0038] The stimulation contacts of the aforementioned stimulation electrode 5 can employ directional stimulation. That is, the cylindrical electrode can be replaced by an arc-shaped electrode, or a portion of the cylindrical electrode's surface can be covered with silicone or similar materials to form a non-circular closed-loop stimulation. Specifically, this embodiment uses four electrode contacts, which can be arranged with two negative electrodes and two positive electrodes, as shown in [reference needed]. Figure 5 As shown, the electrodes are arranged in sequence along their length: negative electrode 502a, negative electrode, positive electrode 502b, and positive electrode. This arrangement, with two negative electrodes (positive electrodes) adjacent to each other, creates a bipolar design with a wider polarity (each polarity electrode has two electrode contacts, thus widening the actual size of the electrode), increasing the contact area with tissues and expanding the range of the stimulation field. Furthermore, this structure makes the electrodes easy to manufacture. Only two wires 501 extend from the stimulator: one serves as the positive electrode, welded to two adjacent columnar / sheet electrodes, and the other serves as the negative electrode, welded to the remaining two adjacent columnar / sheet electrodes. This bipolar design allows for smaller electrodes under the same stimulation field, further reducing the overall size of the elongated stimulation device.

[0039] In one embodiment, see Figure 1 and Figure 5 As shown, the end of the stimulation electrode 5 is provided with a positioning hole 503 for suture fixation. The end of the stimulation electrode 5 has an end cap, the top of which is spherical to further reduce stimulation to tissues in the body. The positioning hole is located on the end cap for easy fixation. In another embodiment, the columnar electrode close to the end cap can have a larger dimension in the length direction of the stimulation electrode than the dimensions of the other stimulation contacts. Its reliable positioning makes it easier to contact the tibial nerve for stimulation, further improving the stimulation effect.

[0040] To better form the stimulation device, in one embodiment, see Figure 1 As shown, the via 401 of the connector 4 serves as a sealant injection hole. When the wire 501 passes through the via 401 and connects to the feedthrough 3, sealant can be injected into the connector through the via 401, ensuring a secure connection between the feedthrough and the wire and guaranteeing a sealed connection at the connector 4. Specifically, the body of the stimulating electrode 5 is sealed to the connector 4, achieving a water seal between the stimulating electrode and the connector, preventing tissue fluid from seeping in after implantation and corroding the wire 501.

[0041] This invention also provides an implantable neurostimulation system, comprising: a programmable controller, a wireless power supply device, and an implantable tibial nerve stimulation device as described in any of the preceding embodiments. The circuit board 2 is equipped with a power receiving coil, and the wireless power supply device is equipped with a power transmitting coil matched to the power receiving coil. The stimulation system of this embodiment can be implanted in the ankle or lower leg near the ankle, allowing the stimulation electrodes to be implanted along the tibial nerve pathway for better contact and stimulation. Compared to existing disc-shaped stimulation electrodes, it is easier to implant and provides better post-implantation adaptation. Its slender, elongated structure can be distributed over a wide range along the length of the tibial nerve, avoiding overstimulation in a specific area. In this embodiment, the stimulation device does not require a battery; it relies on an external wireless power supply device for power, further reducing the size of the stimulation device and making it more suitable for implantable stimulation.

[0042] Although the embodiments of this utility model have been described in detail above, it will be apparent to those skilled in the art that various modifications and variations can be made to these embodiments. However, it should be understood that such modifications and variations fall within the scope and spirit of this utility model as described in the claims. Moreover, the utility model described herein may have other embodiments and can be implemented or realized in various ways.

Claims

1. An implantable tibial nerve stimulation device, characterized by: It includes a connected stimulator, a connector, and a stimulating electrode, wherein the stimulating electrode is collinear with the center line of symmetry of the stimulator; The stimulator includes a housing, a circuit board for generating stimulation pulses, and a feedthrough. The housing is connected to the feedthrough and forms a sealed cavity for accommodating the circuit board. The circuit board and the feedthrough are electrically connected. One side of the connector is fixed to the feedthrough, and the other side of the connector is fixed to the stimulation electrode. The connector has a through hole for a wire in the stimulation electrode to pass through, and the wire is connected to the feedthrough.

2. The implantable tibial nerve stimulation device according to claim 1, characterized in that, The stimulator is a flat cuboid structure, and the two long sides of the stimulator in the width direction are arc surfaces.

3. The implantable tibial nerve stimulation device of claim 2, wherein, The stimulator has a thickness of 3–4.5 mm and a width of 9–12 mm; the total length of the implantable tibial nerve stimulation device is 20–22 mm.

4. The implantable tibial nerve stimulation device of claim 1, wherein, The feedthrough is provided with a guide post on the side facing the connector, and the connector is provided with a guide hole for the guide post to extend into; and / or, the feedthrough is welded to the housing via a flange.

5. The implantable tibial nerve stimulation device of claim 1, wherein, The feedthrough has a protruding guide platform on the side facing the stimulator, and the electrode terminals of the feedthrough pass through the guide platform.

6. The implantable tibial nerve stimulation device of claim 5, wherein, The guide platform is provided with a groove, and the feed-through electrode terminal is located in the groove.

7. The implantable tibial nerve stimulation device of claim 1, wherein, The feedthrough is provided with an annular groove, and one side of the connector has an annular protrusion, which is confined within the annular groove.

8. The implantable tibial nerve stimulation device of claim 1, wherein, The shell includes at least one of the following: 1) The shell is a cuboid and all edges of the cuboid are arc-shaped; 2) The inner wall of the housing is provided with a groove for supporting the circuit board; 3) The material of the shell is ceramic.

9. The implantable tibial nerve stimulation device according to claim 1, characterized in that, The stimulation electrode includes a main body and a plurality of electrode contacts placed on the main body and flush with the surface of the main body. The wire is placed in the main body and connected to the electrode contacts. The electrode contacts are formed by columnar electrodes or sheet electrodes.

10. The implantable tibial nerve stimulation device of claim 1, wherein, The end of the stimulation electrode is provided with a positioning hole for suturing and fixing; or, the through hole is filled with sealant.

11. An implantable neurostimulation system comprising: include: The programmable controller, the wireless power supply device, and the implantable tibial nerve stimulation device as described in any one of claims 1 to 10, wherein the circuit board is provided with a power receiving coil, and the wireless power supply device is provided with a power transmitting coil that matches the power receiving coil.

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