Tibial nerve stimulation device and system for treating overactive bladder

Abstract

The invention provides a tibial nerve stimulation device and system for treating overactive bladder. The tibial nerve stimulation device comprises a program controller, a pulse generator and a stimulation electrode. The program controller is programmed to be capable of sending out signal parameter setting instructions with the frequency ranging from 500 Hz to 100 kHz, the amplitude ranging from 0.1 mA to 10 mA and the pulse width ranging from 1 us to 1 ms. And the pulse generator is in communication connection with the program controller and is used for generating a specific pulse electric signal according to the signal parameter setting instruction. One end of the stimulating electrode can be implanted into the tibial nerve of a tested object, the other end of the stimulating electrode is electrically connected with the pulse generator, and the stimulating electrode is used for receiving the specific pulse electric signal and transmitting the specific pulse electric signal to the tibial nerve for electrical stimulation. The tibial nerve stimulation device provided by the invention can emit a pulse electric signal with a higher frequency to the tibial nerve, not only can be used for treating overactive bladder, but also can effectively relieve untoward effects such as abnormal feeling or muscle activity of a stimulated part in the treatment process.

Description

Technical Field

[0001] The present application relates to the field of medical device technology, and in particular, to a tibial nerve stimulation device and system for treating overactive bladder. Background Art

[0002] Overactive bladder (OAB) is a syndrome characterized by urinary urgency, often accompanied by symptoms such as frequent urination, nocturia and urge incontinence, which seriously affects the quality of life. Treatments for overactive bladder (OAB) usually include behavioral therapy, drug therapy and surgical treatment. Among them, behavioral therapy is only suitable for patients with mild symptoms; drug therapy, as a second-line treatment method, often lacks efficacy and is accompanied by adverse reactions such as dry mouth, constipation and visual impairment, resulting in poor clinical effects and patient compliance; surgical treatment mainly includes botulinum toxin injection and neurostimulation. Among them, botulinum toxin injection is extremely expensive, so the academic community hopes to use neurostimulation to treat refractory OAB.

[0003] Since tibial nerve electrical stimulation has the advantages of good therapeutic effect and less trauma, it has gradually become a nerve stimulation method for treating overactive bladder (OAB) in recent years. The existing tibial nerve stimulator can emit low-frequency pulse electrical signals of about 20Hz to the tibial nerve, and low-frequency electrical stimulation of the tibial nerve can play a role in treating overactive bladder. Summary of the invention

[0004] The present application provides a tibial nerve stimulation device and system for treating overactive bladder, which can emit higher frequency pulse electrical signals to the tibial nerve for treating overactive bladder.

[0005] Specifically, the present application is implemented through the following technical solutions: In one aspect, the present application provides a tibial nerve stimulation device for treating overactive bladder, comprising: a programmer, a pulse generator, and a stimulation electrode; The program controller is programmed to issue signal parameter setting instructions with a frequency of 500 Hz to 100 kHz, an amplitude of 0.1 mA to 10 mA, and a pulse width of 1 us to 1 ms; The pulse generator is in communication connection with the program controller and is used to generate a specific pulse electrical signal according to the signal parameter setting instruction; One end of the stimulation electrode can be implanted into the tibial nerve of the subject, and the other end is electrically connected to the pulse generator to receive the specific pulse electrical signal and transmit the specific pulse electrical signal to the tibial nerve for electrical stimulation to treat overactive bladder.

[0006] Optionally, the program controller is programmed to be able to issue signal parameter setting instructions with a frequency of 3kHz~10kHz.

[0007] Optionally, the programmer is programmed to send out signal parameter setting instructions at a frequency of 5 kHz.

[0008] Optionally, the program controller is also programmed to issue signal parameter setting instructions with a frequency of 5 Hz to 30 Hz.

[0009] Optionally, the tibial nerve stimulation device is designed as an implantable tibial nerve stimulation device.

[0010] Optionally, the pulse generator is designed as an implantable pulse generator.

[0011] Optionally, the program controller is designed as a programmable logic chip. Exemplarily, the program controller can be designed as a programmable logic chip such as CPLD, FPGA, etc.

[0012] Optionally, the stimulation electrode includes a plurality of electrode contacts for cooperating with different positions of the tibial nerve, thereby transmitting the electrical stimulation signal to different positions of the tibial nerve, thereby increasing the stimulation effect of electrical stimulation of the tibial nerve.

[0013] Optionally, the implantable tibial nerve stimulation device further comprises a housing; The implantable pulse generator, the programmable logic chip and the stimulation electrode are integrated in the housing; the multiple electrode contacts are all extended out of the housing, so that the tibial nerve stimulation device can be implanted into the skin to contact the tibial nerve.

[0014] On the other hand, the present application provides a tibial nerve stimulation system, comprising a control terminal and any of the tibial nerve stimulation devices described above.

[0015] Optionally, the control terminal includes a remote controller. In some embodiments, the control terminal can also be a mobile phone, a computer, etc., but is not limited thereto.

[0016] The technical solution provided by this application can achieve the following beneficial effects: The present application provides a tibial nerve stimulation device and system for treating overactive bladder. Different from the existing tibial nerve stimulator, the tibial nerve stimulation device provided by the present application can emit higher frequency pulse electrical signals to the tibial nerve, which can not only be used to treat overactive bladder, but also effectively alleviate adverse reactions such as abnormal sensations or muscle activities in the stimulated area during the treatment process. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1It is a schematic structural diagram of a tibial nerve stimulation device shown in an exemplary embodiment of the present application.

[0018] Figure 2 It is a schematic diagram of the structure of a TNS (Transcutaneous Nerve Stimulator) shown in an exemplary embodiment of the present application.

[0019] Figure 3 It is a structural diagram of a PNS (Peripheral Nerve Stimulator) shown in an exemplary embodiment of the present application.

[0020] Figure 4 It is a structural schematic diagram of an SCS (Spinal Cord Stimulator) shown in an exemplary embodiment of the present application.

[0021] Figure 5 It is a schematic structural diagram of an M-SCS (Multi-modal Spinal Cord Stimulator) shown in an exemplary embodiment of the present application.

[0022] Figure 6 This is a field operation diagram of the bladder test of an adult pig in Example 1 of the present application.

[0023] Figure 7 It is a data result diagram of the final bladder volume test of Examples 1 to 7 of the present application and Comparative Example 1.

[0024] Figure numerals: 1. programmer; 2. pulse generator; 3. stimulation electrode; 31. electrode contact; 32. electrode wire. DETAILED DESCRIPTION

[0025] The technical solution of the present application will be described in detail below in conjunction with the accompanying drawings.

[0026] Here, the technical solutions in the embodiments (or "implementation methods") of the present application will be described clearly and completely in conjunction with the accompanying drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements.

[0027] If there are terms involving directional indications or positional relationships in the embodiments of the present application (such as up, down, left, right, front, back, inside, outside, top, bottom, center, vertical, horizontal, longitudinal, transverse, length, width, counterclockwise, clockwise, axial, radial, circumferential, etc.), such terms are only used to explain the relative positional relationship, movement, etc. between the components under a certain specific posture (as shown in the accompanying drawings); if the specific posture changes, the directional indication or positional relationship will also change accordingly. In addition, the terms "first" and "second" in the embodiments of the present application are only used for the purpose of convenience of description and cannot be understood as indicating or implying relative importance.

[0028] There are two main types of nerve stimulation for OAB: sacral nerve stimulation (SNS) and tibial nerve stimulation (TNS). The mechanism of nerve regulation is extremely complex. The sacral nerve is a complex nerve while the tibial nerve is a simple nerve. The academic community speculated early that complex nerves may have better regulatory effects. Therefore, the mechanism research of sacral nerve stimulation therapy was carried out earlier than that of tibial nerve stimulation therapy.

[0029] Researchers have conducted a large number of experiments and mechanism studies on sacral nerve stimulation, such as "Effects of stimulationsite and stimulation parameters on bladder inhibition by electrical nerve stimulation" published by Andre 'E. Snellings and Warren M. Grill in "BJU INTERNATIONAL" in 2012, "The Effect of sacral nerve stimulation on uterine activity: a pilot study" published by B. Govaert et al. in "Colorectal Disease" in 2010, etc.

[0030] Researchers have found that the frequency range of sacral nerve stimulation that is effective is roughly between 5 and 20 Hz, and no effect is shown at higher frequencies. For this reason, the academic community has established a relatively consensus stimulation mechanism for the sacral nerve (i.e., part of the central nervous system), which is one of the complex nerves. That is, the response mechanism of complex nerves to diseases is a compound feedback effect, that is, the feedback nerve signal is not a simple positive feedback or simple negative feedback of the lower-level nerve signal, but a comprehensive signal feedback through the sensory nerve and motor nerve to regulate the sensory area.

[0031] The description of the relevant mechanisms was well summarized by Stefan De Wachter in his article "Sacral Neuromodulation: Mechanism of Action" in "European Urology Focus" in 2019.

[0032] Influenced by the sacral nerve research, the post-activated tibial nerve stimulation is also studied roughly within this range. Researchers have found that tibial nerve stimulation is effective in the frequency range of 5-30 Hz, such as the study "Prolonged poststimulation inhibition of bladder activity induced by tibial nerve stimulation in cats" published by Changfeng Tai in "American Journal of Physiology-Renal Physiology 300.2" in 2011, and "Feasibility of Long-term Tibial Nerve Stimulation Using a Multi-contact and Wirelessly Powered Neurostimulation System Implanted in Rats" published by Zainab Moazzam in "Urology" in 2017.

[0033] However, the academic community has also found that at too high a frequency, tibial nerve stimulation even shows further aggravation of the patient's condition. For example, Mario Kovacevic published a study titled "Reflex neuromodulation of bladder function elicited by posterior tibial nerve stimulation in anesthetized rats" in American Journal of Physiology-Renal Physiology 308.4 in 2014. At a high frequency of 50Hz, the bladder activity of experimental animals (rats) was not inhibited, but it further increased the bladder activity of experimental animals (rats). The academic community's understanding of the mechanism of the tibial nerve's further activation of OAB at high frequencies is: the academic community believes that according to the classification of nerves, the tibial nerve is classified as a simple nerve, and the sacral nerve is classified as a complex nerve. When both show no significant therapeutic effect at high frequencies, it is simply believed that since the sacral nerve, as a complex nerve, has no significant therapeutic effect at high frequencies, it is also expected that the tibial nerve, as a simple nerve, will be active at high frequencies.

[0034] The applicant's description of the progress of the above-mentioned academic research is to emphasize that, whether starting from the research in the related field of sacral nerve stimulation or from the research in the field of tibial nerve stimulation itself, the current academic community has formed the inherent idea that "high-frequency nerve stimulation cannot effectively treat OAB" based on the current understanding of the mechanism, and has no motivation to conduct nerve stimulation research on the tibial nerve at a higher frequency band.

[0035] Based on a large number of mechanism studies, the applicant recognized the blocking and regulating effect of the tibial nerve in the ultra-high frequency band, and proposed a parameter optimization scheme for the tibial nerve stimulator. The details are as follows: The tibial nerve stimulation device provided in the present application can not only be used to treat overactive bladder by emitting higher frequency pulse electrical signals to the tibial nerve, but can also effectively alleviate adverse reactions such as abnormal sensations or muscle activities in the stimulated area during the treatment process, which is safer and more reliable.

[0036] See also Figure 1The tibial nerve stimulation device for treating overactive bladder provided in the present application comprises: a program controller 1, a pulse generator 2 and a stimulation electrode 3. The program controller 1 is programmed to issue a signal parameter setting instruction of a frequency of 500Hz~100kHz, an amplitude of 0.1mA~10mA and a pulse width of 1us~1ms. The pulse generator 2 is communicatively connected to the program controller 1, and is used to generate a specific pulse electrical signal according to the signal parameter setting instruction. One end of the stimulation electrode 3 can be implanted into the tibial nerve of the subject, and the other end is electrically connected to the pulse generator 2, and is used to receive the specific pulse electrical signal, and transmit the specific pulse electrical signal to the tibial nerve for electrical stimulation to treat overactive bladder.

[0037] The present application adopts programming logic to write the control program of the programmable controller, so that the programmable controller can issue parameter setting instructions for higher frequency pulse electrical signals. After receiving the instructions, the pulse generator can generate higher frequency pulse electrical signals. By using stimulation electrodes to input higher frequency pulse electrical signals into nerve cells, the polarization characteristics of the nerves can be changed to achieve nerve signal blocking. The blocking is applied to the negative feedback nerve pathway, and the blocking time is mostly 1ms~2ms. The tibial nerve ascending signal can be stimulated to achieve the enhancement of the tibial nerve ascending nerve signal in the ascending nerve pathway. The enhanced tibial nerve ascending nerve signal and the bladder pressure feedback nerve signal are transmitted to the central nervous system through the same nerve bundle. Due to the enhancement of the tibial nerve ascending signal, the proportion of nerve impulses induced by the bladder pressure feedback nerve signal in the central nervous system is reduced, thereby reducing the urge to urinate, thereby improving OAB symptoms, and can effectively reduce adverse reactions such as abnormal sensation or muscle activity at the stimulation site.

[0038] Compared with low-frequency tibial nerve stimulation that uses low-frequency and large pulse width to activate the ascending signal of the tibial nerve, this patent uses ultra-high frequency to activate the ascending signal. Conventionally, as the frequency increases and gradually approaches the recovery time of the nerve polarization level, its effect will change from activation to inhibition, because the nerve polarization cannot be restored and remains in a depolarized state. Therefore, frequencies above 50Hz appear to inhibit the ascending signal of the tibial nerve, resulting in an increase in the proportion of bladder pressure feedback signals and worsening OAB symptoms. However, the stimulation device described in this patent can achieve subthreshold stimulation through appropriate amplitude, pulse width and frequency settings, preventing the nerve from entering a depolarized state, thereby directionally activating the ascending signal of the tibial nerve, inhibiting the bladder pressure feedback signal, and improving OAB symptoms.

[0039] It is worth noting that the generation of neural signals requires a certain stimulation intensity, which is manifested as a single large stimulation (i.e., multiple positive neural signals are triggered simultaneously) or continuous small stimulation (a single positive neural signal is triggered multiple times in a short period of time). When the stimulation frequency increases, the duration of a single pulse is too short, and the accumulated charge generated on the neural tissue is too small to reach the threshold for blocking neural signals. In addition, the skin effect in human tissue begins to appear, causing the electric field energy to gather on the surface, reducing the proportion of stimulation energy reaching the nerves, and affecting the stimulation effect. Therefore, the upper limit of the stimulation high frequency is set to 100kHz based on the experimental test results.

[0040] like Figure 2 As shown, the tibial nerve stimulation device provided in the present application may be a TNS (transcutaneous nerve stimulator). In the TNS, the electrode contact 31 is directly disposed on the pulse generator 2, and the pulse generator 2 is directly placed near the nerve target point during implantation to stimulate the target nerve. In one embodiment, as Figure 3 As shown, the tibial nerve stimulation device can also be a PNS (Peripheral Nerve Stimulator). Specifically, the PNS includes: a pulse generator 2, an electrode wire 32 electrically and detachably connected to the pulse generator 2, and an electrode contact 31 arranged at the end of the electrode wire 32. In this solution, the electrode wire 32 is implanted into the patient's body, and the electrode contact 31 is close to the nerve target point, so as to stimulate the nerve target point by outputting an electrical stimulation signal through the pulse generator attached and fixed to the human skin. The advantage of this PNS is that it has a small wound for the patient, can be implanted for a short period of time, and can treat the corresponding disease in a shorter period of time. It can also be used to test the effectiveness of treatment before the implantation of a long-term stimulation device.

[0041] In one embodiment, Figure 4 As shown, the tibial nerve stimulation device can also be an SCS (Spinal Cord Stimulator). As a fully implantable nerve stimulator, the SCS includes a pulse generator 2, an electrode wire 32 that is detachably electrically connected to the pulse generator 2, and an electrode contact 31 disposed on the electrode wire 32. Among them, the pulse generator 2 has a battery and a receiving coil, which are implanted in the human body together with the electrode wire 32 and the electrode contact 31 for operation. After the power inside the pulse generator 2 is consumed, the external power supply uses the transmitting coil to supply power to keep the stimulator working. The advantage of the SCS is that the pulse generator 2 can be implanted in the body for a long time, reducing the impact on the patient's daily life, and only needs to be powered by a charger (not shown) after the power is consumed.

[0042] Of course, in other examples, such as Figure 5As shown, the tibial nerve stimulation device can also be an M-SCS (Multi-modal Spinal Cord Stimulator). As a fully implantable nerve stimulator, the M-SCS directly sets the electrode contact 31 on the pulse generator 2. The pulse generator 2 does not use a battery for energy storage. The energy storage unit is a capacitor. It needs to be continuously wirelessly powered by a matching wireless power supply device placed outside the human body to realize the operation of the pulse generator. The advantages of M-SCS are: Since there is no battery inside the pulse generator 2, the size of the pulse generator 2 implanted in the human body is greatly reduced, the implantation wound is smaller, and the safety is higher. In addition, the problem of battery cycle life is solved at the same time. After the battery cycle life is exhausted, the battery of the external power supply device can be replaced without surgical removal. Of course, the specific structure of the tibial nerve stimulation device is not limited to this.

[0043] Since there is no mature tibial nerve stimulation effectiveness evaluation standard, the experimental verification of this mechanism is carried out in accordance with the animal experiment and clinical evaluation guidelines for implantable sacral nerve stimulation systems for the same disease and the same nerve stimulation method. The experimental animals selected are adult pigs, which are commonly used in animal experimental verification of sacral nerve stimulation for the treatment of overactive bladder. Their tibial nerves are similar to humans in morphology and size, so they are selected as experimental animals for this model. The experimental steps evaluate the effectiveness of the mechanism through the urodynamic measurement indicators of the animal model (the volume of the first detrusor contraction in this experiment). First, saline infusion is used to measure the standard bladder volume model (calibration group), followed by acetic acid infusion to establish an overactive bladder model (OAB group), and then electrical stimulation is used and different frequencies are set to observe the changes in the bladder volume of experimental animals under different stimulations to evaluate the effectiveness of this program.

[0044] Example 1 (1) Basic bladder stress test: Figure 6 As shown, evenly apply lubricant to the front end of a double-lumen urinary catheter of specification model 8F and smoothly insert it into the urethral opening of an adult pig (Note: when encountering resistance, do not force it forward, but withdraw it slightly for a distance and readjust the angle before trying to insert it again). When the double-lumen urinary catheter smoothly enters the urethra through the external urethral opening, continue to gently push it forward until the resistance disappears and urine flows out automatically, indicating that the intubation is successful.

[0045] Then use the ligation method to fix the double-lumen catheter around the urethra. Connect one of the lumens of the double-lumen catheter to a peristaltic pump to infuse normal saline (NS) into the bladder at a rate of 30 mL / min. Connect the other lumen to a pressure sensor to measure the pressure curve of the bladder as the volume increases. The measured pressure curve is used as the basic curve. Record the total volume of normal saline injected from the start of infusion to the first sudden increase in bladder pressure. The total volume of normal saline injected can be approximately regarded as the volume of the bladder. Record the total volume of normal saline injected from the start of infusion to the first sudden increase in bladder pressure three times in a row and take the average value. The final bladder volume test result data is as follows: Figure 7 shown.

[0046] (2) OAB modeling test: Anesthetize the experimental pigs and insert a double-lumen catheter with a specification of 8F according to the above method, and drain all the urine. Implant the tibial nerve stimulation device on the inner side of the ankle skin and do not turn on the machine. Induce overactive bladder syndrome in the experimental pigs, and infuse 5% acetic acid (AA) into the bladder at a rate of 30 mL / min. At the same time, record the pressure curve of the bladder as the volume increases. Record the total volume of normal saline injected from the start of infusion to the first sudden increase in bladder pressure. The total volume of normal saline injected can be approximately regarded as the volume of the bladder. Record the total volume of normal saline injected from the start of infusion to the first sudden increase in bladder pressure for 3 consecutive times and take the average value. The final bladder volume test result data is as follows: Figure 7 shown.

[0047] (3) Tibial nerve electrical stimulation test: After the basic bladder pressure test and OAB modeling test are completed, empty the urine. Implant the tibial nerve stimulation device on the inner side of the ankle skin, turn on the machine, control the program controller to send out pulse electrical signal parameter setting instructions with a frequency of 5kHz, an amplitude of 5mA, and a pulse width of 20us, control the pulse generator to send out a high-frequency pulse electrical signal, induce overactive bladder syndrome in the experimental pigs, and infuse 5% acetic acid (AA) into the bladder at a rate of 30 mL / min. At the same time, record the pressure curve of the bladder as the volume increases. Record the total volume of saline injected from the start of infusion to the first sudden increase in bladder pressure. The total volume of saline injected can be approximately regarded as the volume of the bladder. Record the total volume of saline injected from the start of infusion to the first sudden increase in bladder pressure for 3 consecutive times and take the average value. The final bladder volume test result data is as follows: Figure 7 (5kHz) as shown.

[0048] Example 2 The difference from Example 1 is that during the tibial nerve electrical stimulation test, the program controller is controlled to send a pulse electrical signal parameter setting instruction with a frequency of 500 Hz, an amplitude of 5 mA and a pulse width of 20 us, and the pulse generator is controlled to send a low-frequency pulse electrical signal. Other experimental conditions are the same as in Example 1.

[0049] Example 3 The difference from Example 1 is that during the tibial nerve electrical stimulation test, the program controller is controlled to send a pulse electrical signal parameter setting instruction with a frequency of 1 kHz, an amplitude of 5 mA and a pulse width of 20 us, and the pulse generator is controlled to send a low-frequency pulse electrical signal. Other experimental conditions are the same as in Example 1.

[0050] Example 4 The difference from Example 1 is that during the tibial nerve electrical stimulation test, the program controller is controlled to send a pulse electrical signal parameter setting instruction with a frequency of 3 kHz, an amplitude of 5 mA and a pulse width of 20 us, and the pulse generator is controlled to send a low-frequency pulse electrical signal. Other experimental conditions are the same as in Example 1.

[0051] Example 5 The difference from Example 1 is that during the tibial nerve electrical stimulation test, the program controller is controlled to send a pulse electrical signal parameter setting instruction with a frequency of 7 kHz, an amplitude of 5 mA and a pulse width of 20 us, and the pulse generator is controlled to send a low-frequency pulse electrical signal. Other experimental conditions are the same as in Example 1.

[0052] Example 6 The difference from Example 1 is that during the tibial nerve electrical stimulation test, the program controller is controlled to send a pulse electrical signal parameter setting instruction with a frequency of 10kHz, an amplitude of 5mA and a pulse width of 20us, and the pulse generator is controlled to send a low-frequency pulse electrical signal. Other experimental conditions are the same as in Example 1.

[0053] Example 7 The difference from Example 1 is that during the tibial nerve electrical stimulation test, the program controller is controlled to send a pulse electrical signal parameter setting instruction with a frequency of 100 kHz, an amplitude of 5 mA and a pulse width of 20 us, and the pulse generator is controlled to send a low-frequency pulse electrical signal. Other experimental conditions are the same as in Example 1.

[0054] Comparative Example 1 The difference from Example 1 is that during the tibial nerve electrical stimulation test, the program controller is controlled to send out a pulse electrical signal parameter setting instruction with a frequency of 20 Hz, an amplitude of 5 mA and a pulse width of 20 us, and the pulse generator is controlled to send out a low-frequency pulse electrical signal to induce overactive bladder syndrome in the experimental pigs. Other experimental conditions are the same as those in Example 1. The total volume of physiological saline injected from the beginning of infusion to the first sudden increase in bladder pressure is recorded three times in a row and the average value is taken. The final bladder volume test result data is shown in the attached figure. Figure 7 (20Hz) as shown.

[0055] From the attached Figure 7 It can be seen from the data results that after the overactive bladder syndrome was induced in the experimental pigs by the electrical stimulation methods of Example 1 and Comparative Example 1, the bladder volume increased by more than 10% compared with that without electrical stimulation, and overactive bladder can be treated. At the same time, in Examples 2 to 7, high-frequency stimulation above 500 Hz also showed a therapeutic effect. Among them, the effect of this application in the 3kHz-10kHz frequency band is equivalent to low-frequency stimulation, but the best effect peak point for tibial nerve stimulation is at 5kHz.

[0056] It should be noted that the technical solutions or technical features described in the above embodiments can be combined or supplemented with each other without causing conflicts. The scope of protection of this application is not limited to the precise structures described in the above embodiments and shown in the drawings; all modifications, equivalent substitutions, improvements, etc. made within the spirit and principles of this application should be included in the scope of protection of this application.

Claims

1. A tibial nerve stimulation device for treating overactive bladder, characterized in that: include: Programmer, pulse generator and stimulation electrodes; The program controller is programmed to issue signal parameter setting instructions with a frequency of 500 Hz to 100 kHz, an amplitude of 0.1 mA to 10 mA, and a pulse width of 1 us to 1 ms; The pulse generator is in communication connection with the program controller and is used to generate a specific pulse electrical signal according to the signal parameter setting instruction; One end of the stimulation electrode can be implanted into the tibial nerve of the subject, and the other end is electrically connected to the pulse generator to receive the specific pulse electrical signal and transmit the specific pulse electrical signal to the tibial nerve for electrical stimulation to treat overactive bladder.

2. The tibial nerve stimulation device according to claim 1, characterized in that: The program controller is programmed to send out signal parameter setting instructions with a frequency of 3kHz to 10kHz.

3. The tibial nerve stimulation device according to claim 2, characterized in that: The program controller is programmed to send out signal parameter setting instructions at a frequency of 5 kHz.

4. The tibial nerve stimulation device according to claim 1, characterized in that: The program controller is also programmed to be able to issue signal parameter setting instructions with a frequency of 5 Hz to 30 Hz.

5. The tibial nerve stimulation device according to any one of claims 1 to 4, characterized in that: The tibial nerve stimulation device is designed as an implantable tibial nerve stimulation device.

6. The tibial nerve stimulation device according to claim 5, characterized in that: The pulse generator is designed as an implantable pulse generator.

7. The tibial nerve stimulation device according to claim 6, characterized in that: The programmer is designed as a programmable logic chip.

8. The tibial nerve stimulation device according to claim 7, characterized in that: The stimulation electrode includes a plurality of electrode contacts for cooperating with different positions of the tibial nerve.

9. The tibial nerve stimulation device according to claim 8, characterized in that: The implantable tibial nerve stimulation device also includes a housing; The implantable pulse generator, the programmable logic chip and the stimulation electrode are integrated in the shell; the multiple electrode contacts are all extended out of the shell.

10. A tibial nerve stimulation system, characterized in that: It comprises a control terminal and the tibial nerve stimulation device as described in any one of claims 1 to 9.

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