CN118217536B

CN118217536B - Implantable neurostimulator and system

Info

Publication number: CN118217536B
Application number: CN202410658792.5A
Authority: CN
Inventors: 何罗建; 赵云; 赵春
Original assignee: Beijing New Cloud Medical Technology Co ltd; Suzhou Xinyun Medical Equipment Co ltd
Current assignee: Beijing New Cloud Medical Technology Co ltd; Suzhou Xinyun Medical Equipment Co ltd
Priority date: 2024-05-27
Filing date: 2024-05-27
Publication date: 2024-08-09
Anticipated expiration: 2044-05-27
Also published as: CN118217536A

Abstract

The implantable neurostimulator and the implantable neurostimulator system provided by the embodiment of the invention comprise an electrode, a stimulation circuit and a controller. The electrode includes a first electrode contact and a second electrode contact. The stimulation circuit is configured to generate a first pulse signal at a current period and apply the first pulse signal to the first electrode contact. The compensation circuit is configured to receive the second pulse signal. The controller is electrically connected with the stimulating circuit and the compensating circuit, is configured to control the stimulating circuit and the compensating circuit to be respectively communicated with the first electrode contact and the second electrode contact, and iteratively adjusts the first pulse signal sent by the stimulating circuit in the next period according to the comparison result of the second pulse signal and the preset pulse signal, so that the second pulse signal detected when the first pulse signal reaches the second electrode contact in the next period tends to be consistent with the preset pulse signal, accurate compensation is facilitated for different individuals, accurate control of any electrode contact is realized for the same individual, and uniformity and accuracy of a treatment process are ensured.

Description

Implantable neurostimulator and system

Technical Field

Embodiments of the present invention relate to the field of medical devices, and in particular, to an implantable neurostimulator and system.

Background

With the continued advancement of medical technology, the use of implantable electrical stimulation to treat painful symptoms has become increasingly common. Such treatment is used to relieve pain or other symptoms by implanting electrodes in the patient to stimulate the nervous system, and is commonly used in the management of chronic pain or other chronic symptoms, such as chronic pain, tremor, parkinson's disease, epilepsy, urinary and urinary incontinence, sexual dysfunction, obesity, or gastroparesis, among others.

Implantable neurostimulation systems typically include a stimulation circuit (e.g., including a pulse generator and a battery, etc.) and electrodes. In operation, the pulse signals generated by the stimulation circuit are delivered to the nervous system or nerve fibers of the patient via the electrodes to relieve pain in the patient.

During the course of treatment, it was found that the pain relief effect was different when patients received the electrical stimulation treatment at different locations, resulting in difficulty in achieving the desired effect and even possible negative effects on the health of the patients.

Disclosure of Invention

In view of the above, an embodiment of the present invention provides an implantable neurostimulator and a system thereof, which aim to solve the problem that the therapeutic effect of the conventional implantable neurostimulator is difficult to achieve.

In one aspect, an embodiment of the present invention provides an implantable neurostimulator including an electrode, a stimulation circuit, a controller, and a compensation circuit. The electrode includes a first electrode contact and a second electrode contact configured to stimulate a human body. The stimulation circuit is configured to generate a first pulse signal in a current period and apply the first pulse signal to the first electrode contact to stimulate the human body. The compensation circuit is configured to receive a second pulse signal, the second pulse signal being a pulse signal transmitted by the first pulse signal to the second electrode contact. The controller is electrically connected with the stimulation circuit and the compensation circuit, and is configured to control the stimulation circuit and the compensation circuit to be respectively communicated with the first electrode contact and the second electrode contact, and iteratively adjust a first pulse signal sent by the stimulation circuit in a next period according to the second pulse signal and a preset pulse signal, so that the second pulse signal detected when the first pulse signal reaches the second electrode contact in the next period tends to be consistent with the preset pulse signal.

The implantable neural stimulator can obtain accurate feedback information of the first pulse signal reaching the electrode far-end contact, namely the second pulse signal in real time through the feedback loop formed by the compensation circuit and the stimulation circuit, so that the controller can iteratively adjust the first pulse signal sent by the stimulation circuit in the next period according to the comparison result of the second pulse signal and the preset pulse signal, and the second pulse signal detected when the next period reaches the second electrode contact is ensured to meet the expectations. Because the influence of individual difference on the first pulse signal is different, the feedback mechanism is favorable for realizing accurate compensation for different individuals, is favorable for realizing accurate control on any electrode contact for the same individual, ensures the uniformity and the accuracy of each electrode contact in the treatment process, furthest reduces the interference and the side effect on the human body, and provides safer and more effective treatment experience for patients.

In some examples, the electrode includes a plurality of electrode contacts, the first electrode contact and the second electrode contact being adjacent ones of the plurality of electrode contacts.

The smaller distance can provide more accurate feedback information, so that the pulse signal reaching the electrode far-end contact point in the next period tends to be consistent with the preset pulse signal, and accurate control of any electrode contact point is facilitated, and better treatment experience and effect are provided for patients.

In some examples, the compensation circuit includes a filter that is electrically connected to the controller.

In this way, the pulse signals received by the compensation circuit can filter out interference signals with different frequencies from the first pulse signals, which is beneficial to improving the accuracy, stability and reliability of the pulse signals received by the compensation circuit, thereby being beneficial to improving the accuracy of actual loss and further improving the accuracy of compensation.

In some examples, the implantable neurostimulator further includes a switching circuit connected between the stimulation circuit and the compensation circuit and the electrode configured to turn on the first and second electrode contacts with the stimulation circuit and the compensation circuit, respectively, under control of the controller.

The controller can accurately control the conduction between any electrode contact and the stimulation circuit or the compensation circuit by controlling the switch circuit without setting too many channels in the controller, thereby being beneficial to reducing the volume of the controller. The design ensures that the controller can flexibly control the electrode contacts only by controlling the switch circuit, and the channel number of the switch circuit can be flexibly designed according to the channel number of the controller and the number of the electrode contacts, thereby realizing the accurate control of single electrode contacts and being more convenient. In addition, the implementation mode of the switch circuit is relatively simple, which is beneficial to reducing the manufacturing cost of the implanted nerve stimulator.

In some examples, the implantable neurostimulator further includes an acquisition circuit electrically connected to the controller and configured to receive an evoked compound action potential signal generated by the stimulation circuit in stimulating the human body with a third pulse signal emitted by the stimulation circuit when the controller controls the stimulation circuit and the acquisition circuit to conduct with the first electrode contact and the second electrode contact, respectively.

According to the evoked compound action potential signals received by the acquisition circuit, the medical staff can conveniently analyze and evaluate the treatment effect of the implanted nerve stimulator, and a foundation is provided for the subsequent treatment of patients.

In some examples, the implantable neurostimulator further comprises a switching circuit, the electrode further comprising a third electrode contact, the switching circuit under control of the controller, the first electrode contact, the second electrode contact, and the third electrode contact being in electrical communication with the stimulation circuit, the compensation circuit, and the acquisition circuit, respectively.

The controller can accurately control the conduction between any electrode contact and the stimulation circuit, the compensation circuit or the acquisition circuit by controlling the switch circuit without setting too many channels in the controller, thereby being beneficial to reducing the volume of the controller. The design ensures that the controller can flexibly control the electrode contacts only by controlling the switch circuit, and the channel number of the switch circuit can be flexibly designed according to the channel number of the controller and the number of the electrode contacts, thereby realizing the accurate control of single electrode contacts and being more convenient. In addition, the implementation mode of the switch circuit is relatively simple, which is beneficial to reducing the manufacturing cost of the implanted nerve stimulator.

In some examples, the first electrode contact is a distance from the second electrode contact that is less than a distance from the first electrode contact to the third electrode contact.

The smaller distance between the first electrode contact and the second electrode contact is beneficial to more accurately acquiring feedback information of the electrode contact in treatment, and the larger distance between the first electrode contact and the third electrode contact is beneficial to accurately acquiring ECAP signals, so that more accurate compensation and more efficient treatment are realized.

In some examples, the implantable neural stimulator further includes a first sensor electrically connected to the controller for detecting body position information of the human body and feeding back to the controller, the controller being configured to determine whether the human body is in a standard body position according to the body position information, and if so, control the stimulation circuit to send out a standard pulse signal corresponding to the standard body position.

The design does not need to be compared and iterated with the target ECAP signal through the acquisition circuit, so that time is saved, and the rapid treatment process is facilitated.

In some examples, the controller is configured to iteratively adjust the first pulse signal sent by the next period stimulation circuit according to the comparison result of the evoked compound action potential signal detected by the acquisition circuit and the preset target evoked compound action potential signal in the current period when the human body position is a non-standard body position, so that the evoked compound action potential signal detected by the acquisition circuit and the target evoked compound action potential signal tend to be consistent.

The first sensor is matched with the dynamic adjustment stimulation signals, so that the treatment process is optimized, patients can be treated more accurately and effectively in different positions, and the treatment effect of the patients is improved.

In some examples, the electrodes are distributed along the length of at least one electrode contact set, each electrode contact set comprising three electrode contacts.

In this way, the stimulation circuit, the compensation circuit and the acquisition circuit can work simultaneously, so that the compensation and the treatment are performed simultaneously, thereby being beneficial to improving the accuracy and the high efficiency of the treatment process.

In some examples, the electrodes are distributed along the length of eight electrode contact sets.

Therefore, the coverage ranges of the stimulation signals generated by the electrode contact sets at different positions are also different, so that richer and multi-position accurate treatment can be realized, and the treatment effect and experience are improved.

In some examples, the implantable neurostimulator further includes a circuit board on which the stimulation circuitry, the compensation circuitry, and the battery protection circuitry are disposed, and a battery disposed below the circuit board, separate from the battery protection circuitry.

The battery protection circuit is arranged on the circuit board, so that the stability and the safety of the device are improved, and the safety of a patient in the using process is ensured. Moreover, the design can reserve a larger space for the battery on the premise of not increasing the volume of the device, and the larger battery volume is beneficial to increasing the battery capacity, so that the service life of the device is prolonged, a patient can obtain longer treatment time, and the treatment experience and effect of the patient are improved.

In some examples, the battery protection circuit includes an electrical protection device in series with the battery for disconnecting the battery from the circuit board when the current of the battery is abnormal, and a second sensor located on a surface of the battery for disconnecting the battery from the circuit board when the temperature of the battery is abnormal.

The design is beneficial to rapidly cutting off the circuit when the current or the temperature is abnormal, and the safety of the device is protected.

In some examples, the implantable neurostimulator further comprises a bluetooth module, an NFC module, a first antenna and a second antenna, where the bluetooth module is connected with the first antenna and is used for implementing bluetooth communication between the implantable neurostimulator and the external controller, the NFC module is connected with the second antenna and is used for identifying the device by the external controller, and when the bluetooth module stops working, the bluetooth module is triggered to start working by sending a signal.

Through the cooperation mode of bluetooth module and NFC, can effectively reduce the consumption of device under the sleep mode to promote the duration of use of device.

In some examples, the implantable neurostimulator further includes a first flexible circuit board for connecting the circuit board and a plurality of electrode contact leads, each electrode contact lead electrically connected to one of the electrode contacts, and a second flexible circuit board for connecting the battery and the battery protection circuit.

Compared with the traditional mode of connecting through the pin, through using the flexible circuit board, can reduce the potential safety hazard that leads to because of the connector is too much, reduce discomfort and the risk that the patient received in wearing the in-process, be favorable to improving the security of implanted neural stimulator. In addition, the use of the flexible circuit board is conducive to reducing the volume and weight of the implantable neurostimulator, so that the whole device is more flexible and comfortable, better adapts to the body of a patient, and provides more convenient and comfortable treatment experience.

In some examples, the implantable neurostimulator further comprises a circuit board, a battery, an antenna, a first housing and a second housing, the circuit board being located between the antenna and the battery, the first housing being for housing the circuit board and the battery, the first housing being of a biocompatible metallic material, the second housing being for housing the antenna, the second housing being of a biocompatible non-metallic material.

Thus, the circuit board and the battery can be stably fixed by the biocompatible metal material, which is helpful for improving the strength and the firmness of the implantable neurostimulator. The antenna and the charging coil are protected by the biocompatible plastic shell, so that the charging efficiency of the charging coil is improved, shielding of the antenna can be avoided, and the communication quality is improved. In addition, the biocompatible plastic housing can reduce the weight of the device and can reduce the burden of a patient, thereby being beneficial to improving the wearing comfort.

In another aspect, an embodiment of the present invention also provides an implantable neurostimulation system. The system comprises the implantable neurostimulator and an external controller, wherein the external controller is configured to control the implantable neurostimulator to stimulate a human body according to a control instruction input by an operator.

Through the cooperative work of the above parts, the external controller can realize effective communication interaction with the implanted nerve stimulator so as to ensure the safety and reliability of the system and help provide safer and more effective treatment experience for patients.

Drawings

It is appreciated that the following drawings depict only certain embodiments of the invention and are not to be considered limiting of its scope. The same or similar reference numbers are used in the drawings to identify the same or similar elements. The drawings are merely schematic representations, not necessarily precise in size and proportion of the elements in the drawings.

Fig. 1 is a schematic diagram of an implantable neural stimulation system according to an embodiment of the present invention.

Fig. 2 is a block diagram of a portion of an implantable neurostimulator according to an embodiment of the present invention.

Fig. 3 is a schematic diagram of a compensation circuit according to an embodiment of the invention.

Fig. 4 is a schematic diagram of a compensation circuit according to another embodiment of the invention.

Fig. 5 is a block diagram of a portion of an implantable neurostimulator according to another embodiment of the present invention.

Fig. 6 is a schematic view of a portion of an electrode according to an embodiment of the invention.

Fig. 7 is a timing diagram of a stimulation circuit, a compensation circuit and an acquisition circuit in an implantable neurostimulator according to an embodiment of the present invention.

Fig. 8 is a schematic diagram of the structure of an electrode, a switching circuit, a stimulation circuit, a compensation circuit, an acquisition circuit and a controller in an implantable neurostimulator according to an embodiment of the present invention.

Fig. 9 is a schematic diagram of a battery protection circuit in an implantable neural stimulator according to an embodiment of the present invention.

Fig. 10 is a schematic structural diagram of an implantable neural stimulator according to an embodiment of the present invention.

Fig. 11 is a block diagram illustrating an implantable neural stimulation system according to an embodiment of the present invention.

Detailed Description

Embodiments of the present invention are described below by way of example with reference to the accompanying drawings. It should be understood that the present invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather as a more thorough and clear understanding of the present invention.

The implantable neurostimulation system 100 generally includes a stimulation circuit 11 (e.g., including a pulse generator and a battery, etc.) and an electrode 14, the stimulation circuit 11 for generating a pulse signal for therapy, the electrode 14 being positioned near a target location associated with a patient's brain, spinal cord, pelvic nerve, peripheral nerve, or gastrointestinal tract, such as near the spinal cord, near the sacral nerve, stimulation near the internal and peripheral nerves, commonly referred to as Spinal Cord Stimulation (SCS), sacral Neuromodulation (SNM), deep Brain Stimulation (DBS), and Peripheral Nerve Stimulation (PNS), respectively.

For a brief description of the implantable neurostimulation system 100, the functionality of various components of the implantable spinal cord electrical stimulation system 100 will be described below as an example. Of course, the present invention is not limited to implantable spinal cord electrical stimulation system 100, but is applicable to other implantable electrical stimulation devices.

The implanted spinal cord electric stimulation system 100 implants the electrode 14 into the epidural space of the spinal canal by interventional technique, stimulates spinal nerves of a specific section with pulse current, replaces pain sensation transferred from peripheral sensory nerves with a tolerable crunchy sensation at the spinal level, thereby blocking the uploading of pain sensation to the brain center and effectively relieving chronic intractable pain caused by different causes.

Fig. 1 is a diagram illustrating an application scenario of an implantable neural stimulation system 100 according to an embodiment of the present invention, where the implantable neural stimulation system 100 may include an implantable neural stimulator 10 and an external controller 30. It should be noted that, in fig. 1, and in other drawings of the embodiment of the present invention, arrow L may be used to indicate the length direction in which the electrodes extend, while arrow C may be used to indicate the direction perpendicular to the length direction, and SC is used to indicate the spinal cord of the human body.

As shown in fig. 1, an implantable neural stimulation system 100 may include an implantable neural stimulator 10 and an external controller 30. The implantable neurostimulator 10 is at least partially disposed within a patient and is configured to generate a pulse signal and deliver the pulse signal to the vicinity of a spinal cord SC nerve of the patient. The external controller 30 is disposed outside the patient's body and is configured to control the implantable neurostimulator 10 to stimulate the human body in accordance with control instructions entered by an operator. The specific functions of the external controller 30 will be described in detail below and will not be described again here.

Referring to fig. 1 and 2, implantable neurostimulator 10 generally also includes electrodes 14 and stimulation circuitry 11. At least a portion of the electrode 14 may be implanted into the epidural space of the spinal cord SC of the patient, for example, either to both sides of the spinal cord SC of the patient or to one side of the spinal cord SC. The electrode 14 may include a first electrode contact 141 and a second electrode contact 142 configured to stimulate a human body, for example, a spinal cord SC of the human body, or other parts of the human body, which are not particularly limited herein. The first electrode contact 141 and the second electrode contact 142 may be placed on a specific nerve nucleus, respectively, and the patient is electrically stimulated with one or more contact combinations, thereby alleviating pain of the patient. The stimulation circuit 11 is configured to generate a first pulse signal in a current period and apply the first pulse signal to the first electrode contact to stimulate the human body.

During the course of treatment, patients were found to have differences in pain relief when they received spinal cord stimulation therapy at different locations. For example, some sites can effectively relieve pain, while others have poor therapeutic effects, resulting in difficulty in achieving the desired effect. In particular, the distal contact of electrode 14 (i.e., the end of electrode 14, see fig. 1 and 3) was found to be less effective than the proximal contact (i.e., the end distal to electrode 14). Although attempts are made to compensate for the inherent losses in the transmission, the desired effect is not achieved.

Further analysis has found that this is due to the fact that the implantable neurostimulator 10 is subjected to a significant change in its environment after implantation and prior to implantation. Such environmental changes have some impact on some of the performance parameters of the first pulse signal, including, for example, contact loss, wire and contact impedance, body impedance, etc., making the therapeutic effect of the distal contact of the electrode 14 difficult to predict.

The implantable neurostimulator 10 provided by an embodiment of the present invention can obtain feedback of some performance parameters of the distal contact of the electrode implanted in the body in real time and compensate according to the feedback, so as to improve the therapeutic effect of the distal contact, thereby minimizing the interference and side effects to the human body and better relieving the pain problem of the patient.

Referring to fig. 1 and 2, the implantable neurostimulator 10 further includes a compensation circuit 12 and a controller 13. The compensation circuit 12 is configured to receive a second pulse signal, which is a pulse signal transmitted by the first pulse signal to the second electrode contact 142. The controller 13 is electrically connected to the stimulation circuit 11 and the compensation circuit 12, and is configured to control the stimulation circuit 11 and the compensation circuit 12 to be respectively connected to the first electrode contact 141 and the second electrode contact 142, and iteratively adjust the first pulse signal sent by the stimulation circuit 11 in the next period according to the second pulse signal and the preset pulse signal, so that the second pulse signal detected when the first pulse signal reaches the second electrode contact 142 in the next period tends to be consistent with the preset pulse signal.

It will be appreciated that under the control of the controller 13, the first pulse signal from the stimulation circuit 11 passes through the first electrode contact 141 and the human body, reaches the second electrode contact 142, and is then delivered to the compensation circuit 12. It is understood that the difference between the first pulse signal sent by the stimulation circuit 11 and the second pulse signal delivered to the compensation circuit 12 reflects the actual losses experienced by the implantable neural stimulator 10 in the process of the first pulse signal sent by the stimulation circuit 11 reaching the compensation circuit 12 after being implanted in the body, and these actual losses include, but are not limited to: the transmission loss of the first pulse signal from the emission to the first electrode contact 141 (including but not limited to contact impedance, electrode contact lead impedance, impedance of the first electrode contact 141, etc.), the loss of the first pulse signal when transmitted in human nerve fibers (including but not limited to human absorption, impedance of nerve fibers, etc.), the transmission loss of the first pulse signal to the second electrode contact 142 (including but not limited to impedance of the second electrode contact 142, etc.), and the transmission loss back to the compensation circuit 12 (including but not limited to contact impedance, electrode contact lead impedance, etc.). The controller 13 may adjust the first pulse signal sent by the next-cycle stimulation circuit 11 according to the actual attenuation, so as to ensure that the second pulse signal detected when the next cycle reaches the second electrode contact 142 is consistent with the preset pulse signal.

The compensation circuit 12 and the stimulation circuit 11 form a feedback loop, so that the implantable neural stimulator 10 can obtain accurate feedback information of the first pulse signal reaching the electrode far-end contact in real time, and thus, the controller 13 can timely adjust the output of the stimulation circuit 11 according to the difference between the second pulse signal detected when the first pulse signal actually reaches the electrode contact and the preset pulse signal, so as to ensure that the second pulse signal detected when the next period reaches the second electrode contact 142 meets the expectations. Because the influence of individual difference on the first pulse signal is different, the feedback mechanism is favorable for realizing accurate compensation for different individuals, is favorable for realizing accurate control on any electrode contact for the same individual, ensures the uniformity and the accuracy of each electrode contact in the treatment process, furthest reduces the interference and the side effect on the human body, and provides safer and more effective treatment experience for patients.

The specific form of the first pulse signal emitted by the stimulation circuit 11 may be many, and may be, for example, a pulse signal for treatment, a specific non-therapeutic pulse signal, a continuous pulse signal, or a pulse sequence signal, which is not particularly limited herein.

Note that the preset pulse signal may be the target reception pulse signal, or may be the first pulse signal sent by the stimulus circuit 11, which is not specifically limited herein. When the preset pulse signal is set as the target reception pulse signal, then each electrode contact may set the same target reception pulse signal to ensure that the second pulse signal detected when the next period reaches each electrode contact can reach the preset pulse signal that tends to be uniform. Similarly, when the preset pulse signal is set as the first pulse signal emitted from the stimulus circuit 11, it is also possible to ensure that the second pulse signal detected when the next period reaches any electrode contact can be made uniform. In this way, the controller 13 can timely adjust the output of the stimulation circuit 11 according to the difference between the second pulse signal detected when the electrode contact is actually reached and the target receiving pulse signal, thereby realizing the accurate control of any electrode contact, being beneficial to improving the detection effect and ensuring the safety and comfort of the patient.

To further increase the accuracy of the electrode distal contact pulse signal, referring to fig. 2, the electrode 14 may include a plurality of electrode contacts, and the first electrode contact 141 and the second electrode contact 142 may be adjacent electrode contacts in the plurality of electrode contacts, for example, may be arranged in parallel, side-by-side, or other arrangements. By reducing the distance between the first electrode contact 141 and the second electrode contact 142, the influence of the human body fiber on the first pulse signal is reduced, thereby being beneficial to improving the accuracy of compensation. The smaller distance can provide more accurate feedback information, so that the pulse signal reaching the electrode far-end contact in the next period is enabled to be consistent with the preset pulse signal, the accurate control of any electrode contact is further realized, and better treatment experience and effect are provided for patients.

Referring to fig. 3, the compensation circuit 12 may include only wires to be electrically connected with the controller 13 without separately designing a complicated circuit, which helps to reduce the difficulty of the manufacturing process and the manufacturing cost. In addition, the simple structure is not easy to be abnormal and easy to produce and maintain, so that the implanted nerve stimulator is not easy to fail, and the service life and the treatment effect of the implanted nerve stimulator are improved.

To further enhance the accuracy of the compensation circuit 12 in receiving the pulse signal, referring to fig. 4, the compensation circuit 12 may include a filter 121, and the filter 121 may be electrically connected to the controller 13. In this way, the pulse signal received by the compensation circuit 12 is filtered to remove the interference signal with a frequency different from that of the first pulse signal, which is conducive to improving accuracy, stability and reliability of the pulse signal received by the compensation circuit 12, thereby being conducive to improving accuracy of actual loss and further improving accuracy of compensation.

With continued reference to fig. 5, the compensation circuit 12 may also include an amplifier 122 and a digital-to-analog converter 123. In this way, the pulse signal received by the compensation circuit 12 is more accurate, thereby improving the accuracy of the actual loss. Of course, the amplifier 122 and the digital-to-analog converter 123 in the compensation circuit 12 can also be implemented by the logic of the controller 13.

Referring to fig. 5, the implantable neurostimulator 10 may further include an acquisition circuit 15 configured for receiving an evoked compound action potential signal (ECAP signal) generated by the stimulation of the human body by the third pulse signal emitted by the stimulation circuit 11, when the controller 13 controls the stimulation circuit 11 and the acquisition circuit 15 to be respectively turned on with the first electrode contact 141 and the second electrode contact 142. According to the ECAP signals received by the acquisition circuit, medical staff can conveniently analyze and evaluate the treatment effect of the implanted nerve stimulator, and a foundation is provided for subsequent treatment of patients.

The ECAP signal refers to a potential superposition effect generated by the neuron population of the patient after being excited by the third pulse signal sent by the stimulus circuit 11, and may reflect the response of the nerve fiber to the electrical stimulus. Effective stimulation therapy can alleviate disease symptoms (e.g., pain) in a patient without causing adverse side effects (e.g., intense or uncomfortable stimulation sensations). The effective stimulation therapy corresponds to a particular ECAP characteristic value, and the pain of the patient is effectively alleviated when the ECAP signal received by the controller 13 corresponds to the ECAP characteristic value. The target ECAP may include multiple sets of different ECAP characteristic values for treating different types of pain, and the patient may choose according to his own pain condition. When the ECAP signal received by the controller 13 deviates from the target ECAP, the controller 13 iteratively adjusts the third pulse signal emitted by the stimulus circuit 11 in the next cycle according to the comparison result of the ECAP signal and the target ECAP, so that the third pulse signal detected by the acquisition circuit 15 in the next cycle is consistent with the target ECAP, thereby providing more effective treatment to the patient.

In connection with fig. 7, in order for the compensation circuit 12 and the acquisition circuit 15 to detect the first pulse signal or the third pulse signal emitted by the stimulation circuit 11 in real time, the controller 13 may also include a timing controller electrically connected to the compensation circuit 12 and the acquisition circuit 15, the timing controller being configured to control the stimulation circuit 11 to emit the first pulse signal while controlling the compensation circuit 12 to start receiving the first pulse signal, and to control the acquisition circuit 15 to start receiving the evoked potential complex (ECAP) signal while the stimulation circuit stops emitting the first pulse signal.

Illustratively, when the first pulse signal is the same as the third pulse signal, the stimulation circuit 11 sends the first pulse signal between t ₀-t₁, the compensation circuit 12 receives the first pulse signal between t ₀-t₁, and the acquisition circuit 15 receives the ECAP signal between t ₁-t₂. It can be understood that under the control of the controller 13, the stimulation circuit 11 sends the first pulse signal, and the compensation circuit 12 and the acquisition circuit 15 receive the first pulse signal and the ECAP signal sequentially and time-sharing, so that the compensation and the treatment can be simultaneously performed in one period, and the effect of achieving two purposes is achieved.

By multiplexing the stimulation circuit 11 and performing reasonable time sequence control, the compensation circuit 12 and the acquisition circuit 15 can receive feedback information of electrode contacts for treatment and stimulate spinal fibers at corresponding positions of a patient in a period in a time-sharing manner to generate ECAP signals. The time-sharing treatment mode enables the treatment process to be more efficient, so that a better treatment effect is achieved.

Of course, the acquisition circuit 15 may also implement compensation for the emitted pulse signal based on the received ECAP signal. However, this compensation is relatively complex and time-consuming, since the ECAP signal is obtained by a series of processing operations by the controller and is obtained at the next time the stimulus circuit 11 emits the pulse signal. According to the embodiment of the invention, the compensation circuit 12 is independently arranged, so that the feedback information can be received while the stimulation circuit 11 sends out the pulse signal, and complex processing operation is not needed, thereby being beneficial to improving the compensation time of the implanted point stimulator and further improving the wearing experience and the treatment effect of a patient.

To achieve accurate control of each electrode contact, the controller 13 typically needs to provide a separate channel for each electrode contact. However, an increase in the number of channels causes an increase in the volume of the controller 13. In the implantable medical device, the increase in volume affects the comfort and feel of the patient, and thus minimizing the volume of the controller 13 helps to improve the comfort and feel of the patient's wear.

Referring to fig. 5, the implantable neurostimulator 10 may also include a switching circuit 16. The switching circuit 16 is connected between the stimulation circuit 11 and the compensation circuit 12 and the electrode 14 and is configured to conduct the first electrode contact 141 and the second electrode contact 142 with the stimulation circuit 11 and the compensation circuit 12, respectively, under the control of the controller 13. Illustratively, the electrode 14 further includes a third electrode contact 143, and the switching circuit 16 may, under the control of the controller 13, electrically connect the first electrode contact 141, the second electrode contact 142, and the third electrode contact 143 to the stimulation circuit 11, the compensation circuit 12, and the acquisition circuit 15, respectively.

The controller 13 can precisely control the conduction of any electrode contact with the stimulation circuit 11, the compensation circuit 12 or the acquisition circuit 15 by controlling the switching circuit 16 without providing too many channels in the controller 13, thereby contributing to the reduction of the volume of the controller 13. The design ensures that the controller 13 can flexibly control the electrode contacts only by controlling the switch circuit 16, and the channel number of the switch circuit 16 can be flexibly designed according to the channel number of the controller 13 and the number of the electrode contacts, thereby realizing the accurate control of single electrode contacts and being more convenient. In addition, the implementation of the switching circuit 16 is relatively simple, which is advantageous in reducing the manufacturing costs of the implantable neurostimulator.

It will be appreciated that the implementation of the switching circuit 16 may be varied, for example, by a transistor switching circuit, an optocoupler circuit, or by addressing, and is not limited in detail herein.

In order to obtain an accurate ECAP signal, referring to fig. 5 and 6, the distance d ₂ between the first electrode contact 141 and the third electrode contact 143 should be as large as possible. It will be appreciated that there may be a stimulus artifact after the stimulus circuit 11 sends the third pulse signal, and when d ₂ is small, the acquisition circuit 15 may quickly receive the signal, and the signal may be affected by the artifact, for example, including serious noise, so that the controller cannot accurately obtain the waveform of the ECAP signal from the signal, thereby affecting the therapeutic effect.

With continued reference to fig. 6, the distance d ₁ between the first electrode contact 141 and the second electrode contact 142 is preferably less than the distance d ₂, i.e., d ₁＜d₂, between the first electrode contact 141 and the third electrode contact 143, which facilitates both more accurate compensation and more efficient treatment for any electrode contact.

Preferably, the ratio of the distance d ₂ between the first electrode contact 141 and the third electrode contact 143 to the distance d ₁ between the first electrode contact 141 and the second electrode contact 142 is greater than 2.

It will be appreciated that a smaller d ₁ helps to more accurately obtain feedback information for the electrode contact during treatment, while a larger d ₂ helps to accurately obtain the waveform of the ECAP signal, thereby helping to improve the accuracy and efficiency of the treatment process.

By reasonably designing the distance between the electrode contacts, the method is not only beneficial to improving the accuracy and the high efficiency of the treatment process, but also beneficial to simplifying the system structure, reducing the complexity of debugging and optimizing and reducing the design and manufacturing difficulty.

Referring to fig. 5 and 8, the electrodes 14 may be distributed along the length L with at least one electrode contact set, each including three electrode contacts 141, 142, and 143. In this way, the stimulation circuit 11, the compensation circuit 12 and the acquisition circuit 15 can operate simultaneously, so that the compensation and the treatment are performed simultaneously, thereby helping to improve the accuracy and the efficiency of the treatment process.

Note that, the distribution manner of the three electrode contacts is not particularly limited, and may be, for example, distributed along the length L direction, and d ₁＜d₂, referring to fig. 8, may be distributed along the length L direction and the vertical length C direction at the same time, or the positions of the three contacts may be arbitrarily distributed. In other embodiments of the invention, each electrode contact set may also include other numbers of electrode contacts, for example, 2, 4, or more.

With continued reference to fig. 8, the electrodes may also be provided with eight electrode contact sets, e.g., eight 14', distributed along the length L. Each electrode contact group may include one electrode contact, two electrode contacts, three electrode contacts (refer to fig. 8), or more, and the present invention is not particularly limited. In other embodiments of the invention, fewer or more electrode contact sets may be provided, for example, 4 electrode contact sets, 6 electrode contact sets, or more, as desired for treatment. Therefore, the coverage ranges of the stimulation signals generated by the electrode contact sets at different positions are also different, so that richer and multi-position accurate treatment can be realized, and the treatment effect and experience are improved.

Referring to fig. 4,5 and 11, the implantable neurostimulator 10 may further include a sensor 826, the sensor 826 including a first sensor 19 electrically connected to the controller 13 for detecting body position information of the patient and feeding back to the controller 13, the controller 13 being configured to determine whether the human body is in a standard body position based on the body position information. The storage device 827 in the implantable neurostimulator 10 stores therein standard pulse signals for a patient in a standard posture, such as standing, sitting, prone, etc. When the patient is in the stored standard body position, the controller 13 controls the stimulation circuit 11 to send out the standard pulse signal corresponding to the standard body position, and the comparison iteration between the standard pulse signal and the target ECAP signal is not needed through the acquisition circuit 15, so that the time is saved, the system power consumption is reduced, and the rapid treatment process is facilitated.

It should be noted that the first sensor 826 may include one or more accelerometers, optical sensors, position sensors, or any other type of sensor to obtain body position information, such as coordinates, of the human body, so as to more accurately and quickly sense whether the patient is in a specific body position state.

Referring to fig. 9 and 10, the implantable neurostimulator 10 further includes a circuit board 18, a battery 70, and a battery protection circuit 17, where the circuit board 18 may be provided with the stimulation circuit 11, the compensation circuit 12, and the battery protection circuit 17, and the battery 70 is located below the circuit board 18 and separately provided from the battery protection circuit 17.

Since the battery protection circuit 17 is provided on the circuit board 18, it contributes to the stability and safety of the device and ensures the safety of the patient during use. Moreover, the design can reserve a larger space for the battery 70 on the premise of not increasing the volume of the device, and the larger volume of the battery 70 is beneficial to increasing the capacity of the battery 70, so that the service life of the device is prolonged, a patient can obtain longer treatment time, and the treatment experience and effect of the patient are improved.

Preferably, the battery 70 is a solid state battery, so that the energy density is higher at the same volume, the life is long, the safety performance is high, and the battery is more friendly to the implanted human body equipment.

With continued reference to fig. 9 and 10, the battery protection circuit 17 includes an electrical protection device 71 connected in series with the cell 70a of the battery 70, the electrical protection device 71 being configured to disconnect the battery 70 from the circuit board 18 when the current of the battery 70 is abnormal, and the battery protection circuit 71 further includes a second sensor 72 located on a surface of the battery 70 for disconnecting the battery 70 from the circuit board 18 when the temperature of the battery 70 is abnormal.

The electrical protection device 71 may be located near the battery 70 to quickly cut off the circuit when the current is abnormal, so as to protect the safety of the implantable neural stimulator, for example, may be a recoverable fuse. The second sensor 72 is preferably a temperature sensor 72, which can detect the temperature of the battery 70 in real time, and can be, for example, a thermistor or a thermocouple, referring to fig. 9, the temperature sensor 72 is a thermocouple 72 and is connected to an amplifier 73, and the controller 13 controls the switch 76 to be turned off when the temperature of the battery 70 exceeds a threshold value. Of course, there are many implementations of controlling the off switch 76, and no particular limitation is made herein.

With continued reference to fig. 9-11, the circuit board 18 may also have a power distribution module 74 disposed thereon. The power distribution module 74 is configured to distribute electrical energy within the battery 70 to the stimulation circuit 11, the compensation circuit 12, the acquisition circuit 15, the switching circuit 16, and elements thereof under the control of the controller 13. There are many specific implementations of the power distribution module 74, and no specific limitations are made herein.

With continued reference to fig. 9-11, the implantable neurostimulator 10 further includes a Communication circuit 820, and the Communication circuit 820 may include a bluetooth module, an NFC (NEAR FIELD Communication) module, and an antenna. The antenna may include a first antenna 20 and a second antenna 27, and the bluetooth module is connected to the first antenna 20 for implementing bluetooth communication between the implantable neurostimulator 10 and the external controller 30, and the NFC module is connected to the second antenna 27 for identifying the device 10 by the external controller 30, and for sending a signal to trigger the bluetooth module to start working when the bluetooth module stops working.

It will be appreciated that if the implantable neurostimulator 10 is in an active state, the Bluetooth module is in an on state, maintaining real-time communication, in which case the NFC module and the second antenna 27 are not used. If the implantable neurostimulator 10 stops working, i.e., the bluetooth module is in sleep mode, it is beneficial to reduce the power consumption of the implantable neurostimulator 10. When the implantable neurostimulator 10 is needed, a signal is sent by the NFC module to trigger the bluetooth module, which will cause the bluetooth module to switch from sleep mode to standby mode, thereby communicating with the external controller 30.

Through the cooperation mode of bluetooth module and NFC, can effectively reduce the consumption of device under the sleep mode to promote the treatment duration of implanted neural stimulator.

Referring to fig. 10, the implantable neurostimulator 10 further includes a charging coil 21 and a sleeve 26. The second antenna 27 is sleeved in the charging coil 21, so that the space utilization rate of the implantable neural stimulator 10 can be improved. The sleeve 26 may be adapted to receive one end of the electrode 14 and be connected to the other end of the electrode by electrode contact leads, each of which is electrically connected to one of the electrode contacts, i.e., each of which may be in electrical communication with the switching circuit 16 via an electrode contact lead. Under the control of the controller 13, any electrode contact lead is switched to be conducted with the compensation circuit 12, the stimulation circuit 11 or the acquisition circuit 15 through the switch circuit 16.

Referring to fig. 5 and 10, the circuit board 18 may further include a first flexible circuit board 22 for connecting the circuit board 18 and the plurality of electrode contact leads, and a second flexible circuit board 23 for connecting the battery 70 and the battery protection circuit 17.

Compared with the traditional mode of connecting through pins, through using the flexible circuit board, the potential safety hazard caused by too many connectors can be reduced, the discomfort and risk of a patient in the wearing process are reduced, and the safety of the implanted nerve stimulator is improved. In addition, the use of the flexible circuit board is conducive to reducing the volume and weight of the implantable neurostimulator, so that the whole device is more flexible and comfortable, better adapts to the body of a patient, and provides more convenient and comfortable treatment experience.

With continued reference to fig. 10, the implantable neurostimulator 10 further includes a first housing and a second housing, the circuit board 18 being located between the antenna and the battery 70, the first housing being configured to house the circuit board 18 and the battery 70, the first housing being of a biocompatible metallic material, the second housing being configured to house the first antenna 20, the second antenna 27, the second housing being of a biocompatible non-metallic material.

In this way, the circuit board 18 and the battery 70 may be stably secured by the biocompatible metal material, helping to increase the strength and robustness of the implantable neurostimulator 10. The first antenna 20 and the second antenna 27 are protected by the biocompatible plastic housing, so that the charging efficiency of the charging coil 21 is improved, shielding of the first antenna 20 and the second antenna 27 can be avoided, and the communication quality is improved. In addition, the biocompatible plastic housing can reduce the weight of the device and can reduce the burden of a patient, thereby being beneficial to improving the wearing comfort.

Of course, the second housing may also house the charging coil 21 and the sleeve 26, which is advantageous for improving the space utilization of the implantable neurostimulator.

Referring to fig. 11, the implantable neurostimulator 10 may also include a storage device 827. Storage 827 is used to store usage-related instructions and data, including control policies 828, therapeutic programs 829, target ECAP830, and buffers 831. The control strategy 828 is configured to adjust the third pulse signal, which may be, for example, the voltage strength, pulse width, pulse frequency, etc., of the pulse signal for treatment, to alleviate pain or other symptoms, in accordance with the ECAP signal of the patient. The treatment program 829 may include multiple sets of pulse stimulation parameters for treatment, such as combinations of electrodes, pulse shapes, pulse rates, etc. The target ECAP830 is set and/or adjusted to a set of ECAP characteristic values that are effective to relieve pain in the patient, while still providing effective relief from pain when the distance between the electrode 14 and the nerve fibers is varied. Buffer 831 is used to temporarily store data, such as a first pulse signal or an ECAP signal, for analysis by a healthcare worker, and for increasing the rate of operation of processor 813, thereby improving the patient's therapeutic experience.

For ease of understanding, the various portions of the external controller 30 in the implantable neurostimulation system 100 are described functionally below in connection with FIG. 11. External controller 30 may include communication circuitry 850, storage device 851 and user interface 852, processing circuitry 853 and power supply circuitry 854. The communication circuit 850 is configured to enable wireless communication with the implantable neurostimulator 10, such as may be bluetooth communication, under control of the processing circuit 850 to ensure reliable data transmission. The storage device 851 is used for storing instructions and data, such as pulse signals for treatment, pulse signals for non-treatment, pulse signals for detection, ECAP signals, etc., to ensure effective stimulation parameter settings and treatment effects. The user interface 852 may include a display screen or the like for displaying information related to the delivery of the pulse signal, identifying patient position information, displaying information related to the stimulation circuit 811, the compensation circuit 812 or the acquisition circuit 815, etc., to enable an operator to intuitively understand the system status and patient condition. The processing circuitry 851, which is configured to control the communication circuitry 850 and to execute instructions in the storage device 851, may comprise at least one processor, such as a microprocessor, DSP, ASIC, FPGA, or any other logic circuitry, to ensure efficient operation of the system. The power supply circuit 854 may provide a stable battery to the external controller 30 to ensure proper operation of the system.

In some examples, continuing with fig. 11, implantable neurostimulator 10 may include stimulation circuitry 811, compensation circuitry 812, controller 813, acquisition circuitry 815, electrodes 14, sleeve 26, communication circuitry 820, sensor 826, storage device 827, control strategy 828, therapy program 829, target ECAP 830, buffer 831, power supply circuitry 833, and battery protection circuitry 817. For the design of these circuits and modules, reference may be made to the relevant description of the foregoing embodiments, and details are not repeated here.

Through the cooperative work of the above components, the external controller 30 is able to achieve effective communicative interaction with the implantable neurostimulator 10 to ensure safety and reliability of the system, helping to provide a safer and more effective therapeutic experience for the patient.

For ease of understanding, the compensation and treatment process of the implantable neurostimulation system 100 is briefly described in accordance with one embodiment.

The compensation process comprises the following steps:

The operator selects the compensation command at the user interface 852 of the external controller 30, the communication circuit 853 communicates with the communication circuit 820 of the implantable neurostimulator 10, and the controller 813 begins operation according to the compensation command.

Under the control of the controller 813, the stimulation circuit 811 and the compensation circuit 812 are respectively conducted with the first electrode contact 141 and the second electrode contact 142 through the switch circuit 816, the first pulse signal sent by the stimulation circuit 811 reaches the second electrode contact 142 after passing through the first electrode contact 141 and the human body, and then is delivered to the controller 813 through the compensation circuit 812, and the controller 813 can iteratively adjust the first pulse signal sent by the stimulation circuit 811 in the next period according to the comparison result of the actually detected second pulse signal and the preset pulse signal, so that the second pulse signal detected by the controller 813 in the next period tends to be consistent with the preset pulse signal.

The treatment process comprises the following steps:

The operator selects the treatment instructions at the user interface 852 of the external controller 30, the communication circuit 853 communicates with the communication circuit 820 of the implantable neurostimulator 10, and the controller 813 begins operation according to the treatment instructions. The third pulse signal from the stimulus circuit 811 passes through the first electrode contact 141 and the human body, reaches the second electrode contact 142, and is then delivered to the controller 813 through the acquisition circuit 815.

Under the control of the controller 813, the stimulation circuit 811 and the acquisition circuit 815 are respectively connected to the first electrode contact 141 and the second electrode contact 142 through the switch circuit 816, and if the controller 813 determines that the body position is a non-standard body position according to the body position information fed back by the first sensor 19 in the sensor 826, the controller 813 iteratively adjusts the third pulse signal sent by the stimulation circuit 811 in the next period according to the comparison result of the detected ECAP signal and the target ECAP, so that the third pulse signal detected by the acquisition circuit 815 in the next period is consistent with the target ECAP. If the controller 813 determines a standard posture based on the posture information fed back from the first sensor 19 of the sensors 826, the controller 811 controls the stimulation circuit 811 to emit a standard pulse signal corresponding to the standard posture.

It should be noted that the compensation process and the treatment process may be performed simultaneously or separately, and are not particularly limited herein.

An embodiment of the present invention provides an implantable neural stimulation system 100, wherein a feedback loop is formed by a compensation circuit and a stimulation circuit, so that an implantable neural stimulator can obtain accurate feedback information of a first pulse signal reaching a distal electrode contact in real time, and thus, a controller can iteratively adjust the first pulse signal sent by the stimulation circuit in a next period according to a second pulse signal and a preset pulse signal, so as to ensure that the second pulse signal detected when the next period reaches the second electrode contact meets expectations. Because the influence of individual difference on the first pulse signal is different, the feedback mechanism is favorable for realizing accurate compensation for different individuals, is favorable for realizing accurate control on any electrode contact for the same individual, ensures the uniformity and the accuracy of each electrode contact in the treatment process, furthest reduces the interference and the side effect on a human body, provides safer and more effective treatment experience for patients, can obtain the feedback of the second pulse signal with certain properties of the distal contact of the electrode implanted in the body in real time and compensates according to the feedback, so as to improve the treatment effect of the distal contact, further furthest reduce the interference and the side effect on the human body, and better relieve the pain problem of the patients.

It will be understood that although the terms "first" or "second," etc. may be used in embodiments of the invention to describe various elements (e.g., a first electrode contact and a second electrode contact), these elements are not provided by these terms, which are merely used to distinguish one element from another.

It should be noted that, the drawings merely illustrate examples, and are not limiting to the structure of the circuit diagrams, wherein the circuit diagrams may be parallel or progressive, or may be combined, or circuit units in the circuit diagrams may be mutually referred to and combined, so that various possible combinations are not described in detail in order to avoid unnecessary repetition.

Those of ordinary skill in the art will appreciate that the elements or modules of the examples described in connection with the embodiments disclosed herein may be implemented as electronic hardware, or as a combination of computer software and electronic hardware. Whether such functionality is implemented as hardware or software depends upon the particular application and design constraints imposed on the solution. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present application.

In the several embodiments provided by the present application, it should be understood that the disclosed systems and apparatus may be implemented in other ways. For example, the apparatus embodiments described above are merely illustrative, and the division of the units or modules is merely a logical function division, and there may be additional divisions when actually implemented, for example, multiple units or modules may be combined or integrated into another system, or some features may be omitted or not performed. Alternatively, the coupling or direct coupling or communication connection shown or discussed with each other may be through some interfaces, units or modules, or may be in electrical or other forms.

In addition, each functional unit or module in the embodiments of the present application may be integrated in one processing unit or module, or each unit or module may exist alone physically, or two or more units or modules may be integrated in one unit or module.

The foregoing is merely illustrative of the embodiments of the present invention, and the present invention is not limited thereto, and any person skilled in the art will recognize that changes and substitutions are within the scope of the present invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.

Claims

1. An implantable neurostimulator, characterized by comprising the following steps:

an electrode comprising a first electrode contact and a second electrode contact configured to stimulate a human body;

a stimulation circuit configured to generate a first pulse signal in a current period and apply the first pulse signal to the first electrode contact to stimulate the human body;

A compensation circuit configured to receive a second pulse signal, the second pulse signal being a pulse signal of the first pulse signal transmitted to the second electrode contact through the first electrode contact and the human body;

The controller is electrically connected with the stimulation circuit and the compensation circuit, and is configured to control the stimulation circuit and the compensation circuit to be respectively conducted with the first electrode contact and the second electrode contact, and iteratively adjust a first pulse signal sent by the stimulation circuit in a next period according to a comparison result of the second pulse signal and a preset pulse signal, so that the second pulse signal detected when the first pulse signal reaches the second electrode contact in the next period tends to be consistent with the preset pulse signal.

2. The implantable neurostimulator of claim 1, wherein the electrode comprises a plurality of electrode contacts, the first and second electrode contacts being adjacent ones of the plurality of electrode contacts.

3. The implantable neurostimulator of claim 1, wherein the compensation circuit comprises a filter, the filter being electrically connected to the controller.

4. The implantable neurostimulator of claim 1, further comprising a switching circuit connected between the stimulation circuit and the compensation circuit and the electrode configured to conduct the first and second electrode contacts, respectively, with the stimulation circuit and the compensation circuit under the control of the controller.

5. The implantable neurostimulator of claim 1, further comprising an acquisition circuit electrically connected to the controller, configured for receiving an evoked compound action potential signal generated by the stimulation of the human body with a third pulse signal from the stimulation circuit, when the controller controls the stimulation circuit and the acquisition circuit to conduct with the first electrode contact and the second electrode contact, respectively.

6. The implantable neurostimulator of claim 5, further comprising a switching circuit, wherein the electrode further comprises a third electrode contact, wherein the switching circuit, under control of the controller, turns on the first, second, and third electrode contacts with the stimulation circuit, the compensation circuit, and the acquisition circuit, respectively.

7. The implantable neurostimulator of claim 6, wherein the first electrode contact is a smaller distance from the second electrode contact than the first electrode contact is from the third electrode contact.

8. The implantable neurostimulator of claim 5, further comprising a first sensor electrically connected to the controller for detecting body position information of the human body and feeding back to the controller, wherein the controller is configured to determine whether the human body is in a standard body position according to the body position information, and if so, control the stimulation circuit to emit a standard pulse signal corresponding to the standard body position.

9. The implantable neurostimulator of claim 8, wherein the controller is configured for iteratively adjusting the first pulse signal from the stimulation circuit in the next cycle according to the comparison of the evoked compound action potential signal detected by the acquisition circuit and the preset target evoked compound action potential signal in the current cycle when the body position of the human body is a non-standard body position, so that the evoked compound action potential signal detected by the acquisition circuit and the target evoked compound action potential signal tend to coincide.

10. The implantable neurostimulator of any of claims 1 to 9, wherein the electrodes are distributed lengthwise with at least one electrode contact set, each electrode contact set comprising three electrode contacts.

11. The implantable neurostimulator of any of claims 1 to 9 wherein the electrodes are distributed with eight sets of electrode contacts along the length.

12. The implantable neurostimulator of claim 1, further comprising a circuit board on which the stimulation circuitry, the compensation circuitry, and battery protection circuitry are disposed, and a battery located below the circuit board, separate from the battery protection circuitry.

13. The implantable neurostimulator of claim 12, wherein the battery protection circuit comprises an electrical protection device in series with the battery for disconnecting the battery from the circuit board when the current of the battery is abnormal, and a second sensor on a surface of the battery for disconnecting the battery from the circuit board when the temperature of the battery is abnormal.

14. The implantable neurostimulator of claim 1, further comprising a Bluetooth module, an NFC module, a first antenna, and a second antenna,

The Bluetooth module is connected with the first antenna and used for realizing Bluetooth communication between the implanted nerve stimulator and an external controller, the NFC module is connected with the second antenna and used for identifying the implanted nerve stimulator by the external controller and sending a signal to trigger the Bluetooth module to start working when the Bluetooth module stops working.

15. The implantable neurostimulator of claim 12, further comprising a first flexible circuit board for connecting the circuit board and a plurality of electrode contact leads, each electrode contact lead electrically connected to one electrode contact, and a second flexible circuit board for connecting the battery and the battery protection circuit.

16. The implantable neurostimulator of any of claims 1 to 9, further comprising a circuit board, a battery, an antenna, a first housing and a second housing, the circuit board being located between the antenna and the battery, the first housing being for housing the circuit board and the battery, the first housing being of a biocompatible metallic material, the second housing being for housing the antenna, the second housing being of a biocompatible non-metallic material.

17. An implantable neurostimulation system comprising an implantable neurostimulator according to any one of claims 1-16, and an external controller configured for controlling the implantable neurostimulator to stimulate the human body in accordance with control instructions entered by an operator.