Implantable tibial nerve stimulation device and system

Abstract

The invention provides an implantable tibial nerve stimulation device and system, the implantable tibial nerve stimulation device comprises a stimulator, a connector and a stimulation electrode which are connected, and the symmetrical center line of the stimulation electrode and the symmetrical center line of the stimulator are collinear; the stimulator comprises a shell, a circuit board and a feed-through, the circuit board is used for generating stimulation pulses, the shell is connected with the feed-through to form a sealing cavity for accommodating the circuit board, and the circuit board is electrically connected with the feed-through; one side of the connector is fixed with the feed-through, the other side of the connector is fixed with the stimulating electrode, the connector is provided with a via hole for a wire in the stimulating electrode to pass through, and the wire is connected with the feed-through. The nerve stimulator is easy to implant, the strip-shaped stimulating electrodes are easier to contact with tibial nerves of a patient, the nerve stimulator is more suitable for moving along with ankles of the patient, and the stimulating effect is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of nerve stimulation, and in particular to an implantable tibial nerve stimulation device and a stimulation system. Background Art

[0002] Overactive bladder (OAB) is a bladder disease, mainly manifested as an urgent and sudden urge to urinate. Typical symptoms include frequent urination, urgency, bladder spasm, and urine leakage. Possible causes of OAB include neurological diseases, diabetes, acute urinary tract infections, and bladder masses (such as tumors or bladder stones).

[0003] Based on the current market, the methods for treating overactive bladder (OAB) mainly include sacral neuromodulation technology, transcutaneous nerve stimulation, percutaneous tibial nerve modulation, and implantable tibial nerve modulation, etc.

[0004] Sacral neuromodulation (SNM) is an effective method for treating various lower urinary tract dysfunctions and is becoming increasingly popular in China. This therapy uses an implantable nerve stimulator and electrodes. The electrodes are placed near the sacral nerve, and the nerve stimulator is placed in a subcutaneous pocket in the lower back. By stimulating the sacral nerve, the nerve reflexes of the bladder, colorectum, sphincter, and pelvic floor related to urination and defecation are adjusted, so that the abnormal nerve reflexes reach a new balance, thereby effectively controlling the symptoms of urination and defecation dysfunction. Currently, sacral neuromodulation has a high cost, and the implantation site (the patient's back) is prone to pain, resulting in complications such as difficulty in the patient's leg movement, loss of efficacy, and electrode infection.

[0005] Tibial nerve electrical stimulation (TNS) is an innovative method for treating overactive bladder (OAB). This method inhibits the movement of the bladder by implanting a tibial nerve electrical stimulator to stimulate the tibial nerve in the leg, and treats problems such as frequent urination and urinary incontinence caused by overactive bladder. However, due to the limited implantation position of the implantable tibial nerve electrical stimulator, the volume of this electrical stimulator needs to be smaller than that of other stimulators to avoid inconvenience to the patient caused by excessive volume.

[0006] Therefore, it is necessary to develop an easily implantable tibial nerve electrical stimulation device. Summary of the Invention

[0007] The purpose of the present invention is to provide an implantable tibial nerve stimulation device and its system, which is strip-shaped, small in volume, easy to implant, and can improve the treatment experience of patients.

[0008] The present invention provides an implantable tibial nerve stimulation device, which includes a connected stimulator, a connector, and a stimulation electrode. The stimulation electrode is collinear with the symmetry 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 the 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 two long sides in the width direction of the stimulator 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, a guiding post is provided on one side of the feedthrough facing the connector, and a guiding hole for the guiding post to extend into is provided on the connector; and / or, the feedthrough is welded to the housing through a flange.

[0012] Optionally, a protruding guiding platform is provided on one side of the feedthrough facing the stimulator, and the electrode terminal of the feedthrough penetrates through the guiding platform.

[0013] Optionally, a groove is provided on the guiding platform, and the electrode terminal of the feedthrough is located in the groove.

[0014] Optionally, the feedthrough is welded to the housing through a flange.

[0015] Optionally, an annular groove is provided on the feedthrough, and an annular protrusion is provided on one side of the connector. The annular protrusion is limited in the annular groove.

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

[0017] Optionally, 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.

[0018] Optionally, positioning holes for suture fixation are provided at the end of the stimulation electrode; or, the through hole is filled with sealant.

[0019] The present invention also provides an implantable nerve stimulation system, which includes: a programmer, a wireless power supply device, and the implantable tibial nerve stimulation device described in any one of the above. An electric energy receiving coil is provided on the circuit board, and the wireless power supply device is provided with an electric energy transmitting coil matching the electric energy receiving coil.

[0020] The implantable tibial nerve stimulation device and stimulation system of the present invention have the following beneficial effects: The stimulation electrode is collinear with the symmetry center line of the stimulator, so that the tibial nerve stimulation device is a symmetric structure, and the whole is in a long strip shape. The line-shaped structure stacked from the stimulator to the stimulation electrode is easy to implant, and the strip-shaped stimulation electrode is more likely to contact the patient's tibial nerve and is more suitable for moving with the patient's ankle joint, improving the stimulation effect; While the stimulator realizes electrical connection with the stimulation electrode through the feedthrough and the connector, it also realizes a firm mechanical connection, which is easy for assembly and production; The implantable nerve stimulation system of the present invention realizes wireless power supply of the stimulator, so that the stimulator does not need to carry a battery, further reducing its volume, making it easier to implant into the body and easier to correspond to the tibial nerve. Description of the Drawings

[0021] Figure 1 Shown is an exploded view of an embodiment of the implantable tibial nerve stimulation device of the present invention; Figure 2 Shown is an axonometric view of the feedthrough; Figure 3 Shown is another axonometric view of the feedthrough; Figure 4 Shown is an embodiment view of the connector; Figure 5 Shown is an embodiment view of the stimulation electrode.

[0022] In the figure, 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 guiding post; 303 is the electrode terminal; 304 is the guiding platform; 401 is the through hole; 402 is the guiding 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; 502b is the positive electrode. Detailed Embodiments

[0023] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be described clearly and completely below. Apparently, the described embodiments are some, but not all, of the embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention. Unless otherwise defined, the technical terms or scientific terms used herein shall have the ordinary meanings as understood by those of ordinary skill in the art to which the present invention pertains. The words such as "including" used herein mean that the elements or items appearing before this word cover the elements or items listed after this word and their equivalents, without excluding other elements or items.

[0024] Currently, the methods for overactive bladder (OAB) on the market mainly include sacral neuromodulation technology, percutaneous tibial nerve stimulation, and implantable tibial nerve stimulation. Among them, sacral neuromodulation technology mainly implants a nerve stimulator in the patient's back, which is likely to cause various complications to the patient; percutaneous tibial nerve stimulation is a non-invasive treatment that mainly uses high-voltage current to complete stimulation. Since the energy is transmitted through the skin to the tibial nerve and decays greatly during the transmission process, the device output energy needs to be relatively large, the patient's physical sensation is slightly poor, and there are unknown harms to other cells around the stimulation; the implantable tibial nerve stimulation currently mainly uses the function of the stimulator's housing to be compatible with the electrode, which has high requirements for the design and production of the electrode. It is mainly implanted at the ankle to stimulate the tibial nerve at the ankle, which has a greater impact on the patient's activities and makes the patient unable to do strenuous exercises such as jumping.

[0025] The tibial nerve is one of the most important mixed nerves in the lower extremities of the human body. It is one of the two terminal branches of the Sciatic Nerve. It branches from the sciatic nerve above the popliteal fossa (behind the knee) and descends along the deep surface of the deep fascia on the posterior side of the calf, passing through the space between the soleus muscle and the posterior tibial muscle; it enters the sole of the foot behind the medial malleolus and divides into the medial plantar nerve and the lateral plantar nerve.

[0026] An embodiment of the present invention provides an implantable tibial nerve stimulation device, as shown in Figure 1As shown in the figure, it includes a connected stimulator, a connector 4, and a stimulating electrode 5. The stimulating electrode 5 is collinear with the symmetry center line of the stimulator. In this embodiment, the stimulating electrode 5 is strip-shaped. The stimulating electrode is collinear with the symmetry center line of the stimulator. On the one hand, the symmetric structure is convenient for production and manufacturing. On the other hand, it is convenient for implantation, and it is easy for the patient to adapt after implantation, reducing foreign body rejection and the occurrence of complications. Specifically, the stimulator includes a housing 1, a circuit board 2 for generating stimulating 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, the other side of the connector 4 is fixed to the stimulating electrode 5, and 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 realizes electrical connection with the stimulating electrode 5 through the feedthrough 3, realizes mechanical connection with the stimulating electrode 5 through the connector 4, and forms a stacked structure through the sequential connection of the housing 1, the feedthrough 3, and the connector 4. The through hole of the connector 4 ensures that the stimulating electrode 5 can be located on the symmetry center line of the housing 1, which is convenient for production and assembly to form a long strip 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 volume of the stimulator can be minimized. Various circuit elements are arranged on the circuit board 2 and can be configured to generate direct current pulses or stimulating signals, which are transmitted to the tibial nerve through the stimulating electrode. Furthermore, the stimulator is in a flat shape, which is more convenient for implantation. The stimulating device in this embodiment is basically strip-shaped. The stimulator can be implanted near the ankle bone of the calf, and the stimulating electrode can be distributed along the direction of the tibial nerve. For example, its end can be fixed closer to the tibial nerve, providing electrical stimulation to the tibial nerve at the back of the calf to improve the stimulation effect. On the other hand, the strip-shaped stimulating electrode is softer compared with the existing disc-shaped stimulating electrode, that is, it is convenient for extension, can increase the multi-point stimulating contact in the length direction of the tibial nerve, and will not affect the jumping movement of the patient.

[0028] The above-mentioned circuit board 2 mainly integrates a power supply, a stimulation circuit, a communication circuit, and a control circuit. In this specification, the circuit components on the circuit board are not limited. It can achieve communication with an external programmer and can generate functions such as stimulation pulses that an in-vivo stimulator has. In this embodiment, the power supply and the circuit board 2 can be stacked in a direction perpendicular to the symmetry center line of the above-mentioned stimulator, successively reducing the length of the housing; this power supply can be a wireless charging power supply. In another embodiment, to reduce the volume of the stimulator, only a power receiving coil that can receive wireless power supply is provided on the circuit board 2. The setting of the power receiving coil enables the stimulator not to be provided with a power supply, and only a power supply device that can achieve wireless charging needs to be worn outside the body; to facilitate the alignment of wireless charging, in one embodiment, redundant coils are provided on the circuit board, and impedance detection can be performed between the redundant coils and the external charging device to achieve better coil alignment.

[0029] To facilitate implantation and improve the comfort after implantation, in one embodiment, the stimulator is a flat cuboid structure, and the two long side surfaces in the width direction of the stimulator are arc surfaces. The flat shape enables the stimulator to be only located in the skin tissue during implantation, thereby facilitating external charging and external control of the stimulator; the setting of the arc surface can reduce the friction between the stimulator and the internal tissues, reduce the foreign body sensation in the body, and further reduce the occurrence of complications. The stimulation device composed of the flat stimulator and the stimulation electrode 5 has an overall long strip structure with a flat head end, making it easier to implant. Only by placing the stimulator on the body surface and using an implantation sheath tube can the stimulation electrode be implanted into the body to be consistent with the tibial nerve direction, which is more convenient for stimulating the tibial nerve and improving the stimulation effect. In a specific embodiment, the thickness of the stimulator is 3 - 4.5 mm, such as 3.5 mm - 4 mm; the width is 9 - 12 mm; the total length of the implantable tibial nerve stimulation device is 20 - 22 mm.

[0030] In one embodiment, as shown in Figure 2 and Figure 4 shown, a guiding post 302 is provided on one side of the feedthrough 3 facing the connector 4, and a guiding hole 402 for the guiding post 302 to extend into is provided on the connector 4. In this embodiment, through the setting of the guiding hole 402 and the guiding post 302, it is convenient for the rapid assembly of the connector 4 and the feedthrough 3 and for the two to be adhesively connected; it further ensures 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] For the convenience of fixedly connecting the feedthrough 3 and the connector 4, in one embodiment, an annular groove 301 is provided on the feedthrough 3, and an annular protrusion 403 is provided on one side of the connector 4. The annular protrusion 403 is limited 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 on the one hand, and on the other hand, facilitates the injection of sealant, increases the contact area between the feedthrough 3 and the connector 4, provides the stability of adhesion, and improves the waterproof property, so as to avoid the tissue fluid in the body from entering and eroding the above-mentioned wires and electrode terminals after implantation.

[0032] In the assembly of the feedthrough 3 and the connector 4 in this embodiment, through the cooperation of the guiding post 302 and the guiding hole 402, and the annular protrusion 403 and the annular groove 301, multiple positioning and guiding are adopted to improve the coaxial design of the symmetry center line of the stimulator and the stimulating electrode 5, improve the symmetry of the tibial nerve stimulation device, and make it easy to implant and use.

[0033] In one embodiment, as shown in Figure 3 shown, the side of the feedthrough 3 facing the housing 1 has a protruding guiding platform 304. The electrode terminal 303 of the feedthrough 3 penetrates through the guiding platform 304. The guiding platform 304 can facilitate the assembly and positioning of the feedthrough 3 and the flange 6. The guiding platform 304 can be embedded in the flange 6 for convenient welding and fixing. A groove is provided on the guiding platform 304, and the electrode terminal 303 of the feedthrough is located in the groove. The existence of the groove can facilitate the connection between the electrode terminal 303 and the circuit board, further shorten the connection distance between the circuit board and the feedthrough, and reduce the volume 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, which can make the end face of the housing 1 and the above-mentioned guiding platform 304 fully contact with the welding grooves, improve the stability and sealing property of the welding, and ensure that the circuit board 2 is hermetically placed.

[0034] In one embodiment, the above-mentioned housing 1 is a cuboid and the edges of the cuboid are all arc-shaped. The arc-shaped setting can improve the comfort after implantation, reduce the friction between it and the tissues in the patient's body, and reduce complications; specifically, in the length direction of the housing (the length direction is the direction consistent with the extension direction of the stimulating electrode), both of its two long side faces are arc-shaped surfaces. Grooves for supporting the circuit board 2 are provided on the inner wall of the housing 1. The grooves are used to support and position the circuit board 2 to improve the stability of the circuit board. Based on the fact that the stimulator is implanted at the patient's ankle or near the ankle of the calf, this place belongs to a position with frequent activities and large forces, so it is easy to drive the stimulator to vibrate. In order to prevent the circuit board from not working or the stimulation output from being unstable due to vibration, or disconnecting from the electrode terminal on the feedthrough, in this embodiment, grooves are provided on the inner walls of the opposite sides of the housing 1 to limit and support the circuit board 2 to prevent spatial displacement between the circuit board 2 and the housing 1.

[0035] Specifically, the material of the above-mentioned housing 1 is ceramic. The cavity space of the housing 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 cavity space is relatively small. The above-mentioned circuit board 2 is clamped in the housing 1. In a preferred embodiment, the above-mentioned circuit board 2 is only provided with an electric energy receiving coil that can receive wireless power supply, further reducing the overall size of the stimulator. The housing 1 can be formed by 3D printing, and three-dimensional simulation can be carried out based on its implantation position to make it more ergonomic, facilitate its integration into the body tissue after implantation, move with the tissue, and avoid stimulating the tissue to cause complications. For example, the arc of one side of it is consistent with the arc of the muscle movement track in the body. For the convenience of fixation after implantation, in one embodiment, the ceramic housing 1 is provided with positioning holes or positioning grooves for implantable fixation, or the housing 1 has growth holes for tissue growth to enter. For example, the growth holes are filled with photocurable hydrogel, which can enable the tibia or body tissue to extend into the growth holes for growth, realizing "bio-electronic symbiotic fixation". In yet another embodiment, the housing 1 is provided with protrusions, grooves, or an electromagnetic positioning structure is provided inside the housing 1 (such as an electromagnetic positioning coil or an electromagnetic positioning block is arranged on the circuit board, etc.), which is convenient for mechanical or electromagnetic guiding alignment positioning with the external wireless charging device.

[0036] In one embodiment, see Figure 1 and Figure 5 As shown, the above-mentioned stimulating electrode 5 includes a main body and a plurality of electrode contacts (the columnar electrodes 502 in this embodiment constitute the electrode contacts) placed on the main body and flush with the surface of the main body. The wire 501 is placed in the main body and connected to the electrode contacts. In this embodiment, the main body can be a tubular part. The outer diameter of the columnar electrode 502 is the same as or approximate to the outer diameter of the tubular part. A plurality of tubular parts and a plurality of columnar electrodes are connected in series. The wire is threaded through the tubular part and welded and conducted and fixed at the inner surface of the columnar electrode. By setting the size of the columnar electrode to be consistent with the main body, the outer surface of the stimulating electrode is a smooth surface without abnormal surfaces such as unevenness, which is convenient for implantation, reduces the foreign body sensation after implantation, and reduces the occurrence of complications after implantation. For example, the unevenness may cause inflammation caused by stimulating the body tissue.

[0037] The above-mentioned electrode contacts can be formed by columnar electrodes or can be formed by sheet electrodes, that is, the structure of the electrode contacts themselves is not limited here. In one embodiment, the number of columnar electrodes is 4, which can stimulate multiple points along the direction of the tibial nerve to improve the stimulation effect. In addition, if the setting of multiple columnar electrodes can meet redundant stimulation, it can avoid the problem that the tibial nerve cannot be electrically stimulated due to problems with the columnar electrodes themselves. To improve the stimulation performance, in one embodiment, the spacing between the columnar electrodes is 3.5-4.5 mm.

[0038] Each stimulation contact of the above-mentioned stimulation electrode 5 can adopt directional stimulation, that is, the above-mentioned columnar electrode can be replaced by an arc-shaped electrode, or part of the surface of the columnar electrode can be covered by coating silica gel or the like to form a non-circular closed-loop stimulation. Specifically, in this embodiment, 4 electrode contacts are adopted, which can be arranged in the way of two negative electrodes and two positive electrodes. See Figure 5 as shown, that is, along the length direction of the stimulation electrode, there are a negative electrode 502a, a negative electrode, a positive electrode 502b, and a positive electrode in sequence. Thus, by the form of two adjacent negative electrodes (positive electrodes), a bipolar design with a wider polarity is formed (that is, each polar electrode is composed of two electrode contacts, thereby widening the actual size of the electrode), increasing the contact area with the tissue in the body and at the same time increasing the range of the stimulation electric field; on the other hand, the stimulation electrode with this structure is easy to manufacture. Only two wires 501 need to extend from the stimulator. One is used as the positive electrode and is welded to two adjacent columnar electrodes / sheet electrodes, and the other is used as the negative electrode and is welded to the remaining two adjacent columnar electrodes / sheet electrodes. The bipolar design can achieve a smaller-sized stimulation electrode under the same stimulation electric field condition, and further reduce the overall size of the strip-shaped 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, and the top of the end cap is spherical, further reducing the stimulation to the tissue in the body. The positioning hole is arranged on the end cap for easy fixation. In another embodiment, for the columnar electrode close to the end cap, its size in the length direction of the stimulation electrode can be larger than that of the other several stimulation contacts, and its positioning is more reliable and it is easier to contact with the tibial nerve stimulation, further improving the stimulation effect.

[0040] To better form the stimulation device, in one embodiment, see Figure 1 as shown, the through hole 401 of the above-mentioned connector 4 is used as a sealant perfusion hole. When the wire 501 passes through the through hole 401 and is connected to the feedthrough 3, sealant can be poured into the connector through the through hole 401 to firmly connect the feedthrough and the wire by the connector 4, ensuring the sealed connection at the connector 4. Specifically, the main body of the stimulation electrode 5 is hermetically connected to the connector 4 to achieve the water seal between the stimulation electrode and the connector, avoiding the infiltration of tissue fluid in the body after implantation and further corroding the wire 501.

[0041] The present invention further provides an implantable nerve stimulation system, which includes: a programmer, a wireless power supply device, and the implantable tibial nerve stimulation device as described in any one of the above. An electric energy receiving coil is provided on the circuit board 2, and the wireless power supply device is provided with an electric energy transmitting coil matching the electric energy receiving coil. The stimulation system of this embodiment can be implanted near the ankle or the lower leg close to the ankle, so that the stimulation electrode can be implanted along the direction of the tibial nerve, better contacting and stimulating the tibial nerve. Compared with the existing disc-shaped stimulation electrode, it is easier to implant and has a better sense of adaptation after implantation. Its slender strip structure can be distributed over a large range along the length of the tibial nerve, avoiding over-stimulation in a certain area. In this embodiment, the stimulation device does not need to carry a battery and relies on the external wireless power supply device to provide power, further reducing the volume of the stimulation device and making it more suitable for implantable stimulation.

[0042] Although the embodiments of the present invention have been described in detail above, it is obvious to those skilled in the art that various modifications and changes can be made to these embodiments. However, it should be understood that such modifications and changes are all within the scope and spirit of the present invention described in the claims. Moreover, the present invention described herein can have other embodiments and can be implemented or realized in various ways.

Claims

1. An implantable tibial nerve stimulation device, characterized in that: It includes a connected stimulator, a connector, and a stimulating electrode, wherein the stimulating electrode is colinear with a symmetric center line of the stimulator; The stimulator comprises 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. 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 rectangular parallelepiped structure, and two long side surfaces in the width direction of the stimulator are arc surfaces.

3. The implantable tibial nerve stimulation device according to claim 2, characterized in that: The thickness of the stimulator is 3 to 4.5 mm, and the width is 9 to 12 mm; the total length of the implantable tibial nerve stimulation device is 20 to 22 mm.

4. The implantable tibial nerve stimulation device according to claim 1, characterized in that: A guide column is provided on a side of the feedthrough facing the connector, and a guide hole for the guide column to extend into is provided on the connector; and / or the feedthrough is welded to the shell via a flange.

5. The implantable tibial nerve stimulation device according to claim 1, characterized in that: The feedthrough has a protruding guide platform on one side facing the stimulator, and the electrode terminal of the feedthrough passes through the guide platform.

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

7. The implantable tibial nerve stimulation device according to claim 1, characterized in that: The feed-through is provided with an annular groove, and one side of the connector is provided with an annular protrusion, and the annular protrusion is confined in the annular groove.

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

9. The implantable tibial nerve stimulation device according to claim 1, characterized in that: The stimulation electrode comprises 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 according to claim 1, characterized in that: 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 neural stimulation system, characterized in that: include: A programmer, a wireless power supply device, and an 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 matching the power receiving coil.

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