Implantable nerve stimulator system and control method thereof

Abstract

The invention relates to an implantable nerve stimulator system and a control method thereof. The system comprises an in-vitro energy controller and an implantable nerve stimulator. The in-vitro energy controller sends an input signal including energy and control information to the implantable nerve stimulator, and the implantable nerve stimulator maintains operation according to the energy and forms a stimulation signal having a stimulation period, effective stimulation time and stimulation intensity according to the control information; the in-vitro energy controller is configured to continuously send energy in an initial energy supply time period after starting so as to maintain the implantable nerve stimulator to configure a stimulation signal; energy is sent according to a specific duty ratio in each energy supply period after the initial energy supply time period, the duty ratio is determined by the stimulation period, the effective stimulation time and the stimulation intensity of the stimulation signal, and the energy supply periods are in one-to-one correspondence with the stimulation periods, so that synchronization of energy supply of the in-vitro energy controller and stimulation of the implantable nerve stimulator is realized. According to the invention, the problem that an in-vitro energy controller and an implantable nerve stimulator are severe in heating is solved.

Description

Technical Field

[0001] This invention relates to the technical field of neurostimulators, and more particularly to implantable neurostimulator systems and their control methods. Background Technology

[0002] Implantable neurostimulation systems are widely used in the medical field. Currently, implantable neurostimulation systems mainly include implantable neurostimulators placed inside the body and external controllers placed outside the body. An implantable neurostimulator is a device that surgically implants a neurostimulation chip and electrodes into a patient's muscle or nerve tissue through a shell. It can electrically stimulate specific muscles or nerves according to the patient's condition. By stimulating the patient's nerves, it can help relieve pain, or by stimulating the patient's muscles, it can help restore specific functions. The implantable neurostimulator communicates with the external controller via radio frequency to receive control signals from the external controller and receive energy from the external controller. Specifically, the external controller provides radio frequency control signals in real time to drive the electrodes of the implantable neurostimulator, thereby applying stimulation signals to the patient's treatment site. The external controller also provides radio frequency energy to the implantable neurostimulator to maintain its operation.

[0003] Currently, there are relatively few implantable neurostimulators. Existing implantable neurostimulator solutions mostly focus on optimizing the matching circuit to obtain more stable communication quality; however, this is far from sufficient. Due to the very low efficiency of wireless power transmission, without a reasonable wireless power transmission scheme, and while ensuring communication quality under abnormal conditions such as antenna movement, problems such as high power consumption, severe overheating, and short battery life of the external power controller, as well as severe overheating of the implantable neurostimulator, will inevitably arise. These issues seriously affect treatment efficacy and may even cause irreversible damage to the patient.

[0004] The above description of the background technology is only for the purpose of facilitating a deeper understanding of the technical solution of the present invention (the technical means used, the technical problems solved, and the technical effects produced, etc.), and should not be regarded as an admission or in any form an implication that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0005] The purpose of this invention is to provide an implantable neurostimulator system and its control method that can solve the problem of severe overheating in external energy controllers and implantable neurostimulators.

[0006] According to one embodiment of the present invention, an implantable neurostimulator system is provided, comprising an external controller and an implantable neurostimulator. The external controller sends an input signal including energy and control information to the implantable neurostimulator. The implantable neurostimulator maintains operation based on the received energy and forms a stimulation signal with a stimulation cycle, effective stimulation time, and stimulation intensity for application to a treatment site on a patient based on the received control information. The external controller is configured to: continuously send energy during an initial power supply period after startup to maintain the stimulation signal configured in the implantable neurostimulator; and send energy with a specific duty cycle in each power supply cycle after the initial power supply period, the duty cycle being determined by the stimulation cycle, effective stimulation time, and stimulation intensity of the stimulation signal, and the power supply cycle corresponds one-to-one with the stimulation cycle to achieve synchronization between the power supply of the external controller and the stimulation of the implantable neurostimulator.

[0007] The stimulation signal may have a preceding neural stimulation zone and a following non-neural stimulation zone within each stimulation cycle. The neural stimulation zone may include a forward stimulation zone for generating a positive current pulse, a reverse stimulation zone for generating a negative current pulse, and a transition zone between the forward and reverse stimulation zones. The pulse amplitude of the positive and negative current pulses represents the stimulation intensity of the stimulation signal, the duration of the neural stimulation zone represents the effective stimulation time, and the sum of the durations of the neural stimulation zone and the non-neural stimulation zone represents the stimulation cycle.

[0008] The external energy controller can be configured such that: the duty cycle is set to be greater than the ratio of the effective stimulation time to the stimulation cycle, and the difference between the duty cycle and the ratio of the effective stimulation time to the stimulation cycle is related to the ratio of the effective stimulation time to the stimulation cycle and / or the stimulation intensity; based on the same ratio of the effective stimulation time to the stimulation cycle, the greater the stimulation intensity, the greater the difference between the duty cycle and the ratio of the effective stimulation time to the stimulation cycle; based on the same stimulation intensity, the smaller the ratio of the effective stimulation time to the stimulation cycle, the greater the difference between the duty cycle and the ratio of the effective stimulation time to the stimulation cycle.

[0009] The energy supply cycle is equal to the stimulation cycle, and each energy supply cycle can begin earlier than the corresponding stimulation cycle.

[0010] The external controller is configured to acquire the maximum and minimum voltages of the stimulation signal, and / or the average current in the positive and negative stimulation regions, in order to adjust the output power of the external controller.

[0011] According to another embodiment of the present invention, a control method for an implantable neurostimulator system is provided. The implantable neurostimulator system includes an external controller and an implantable neurostimulator. The control method includes: the external controller sending an input signal including energy and control information to the implantable neurostimulator; the implantable neurostimulator maintaining operation based on the received energy and forming a stimulation signal with a stimulation period, effective stimulation time, and stimulation intensity for application to a treatment site on a patient based on the received control information; the external controller continuously sending energy during the initial power supply period after startup to maintain the stimulation signal configured in the implantable neurostimulator; and the external controller sending energy with a specific duty cycle in each power supply cycle after the initial power supply period, the duty cycle being determined by the stimulation period, effective stimulation time, and stimulation intensity of the stimulation signal, and the power supply cycle corresponding one-to-one with the stimulation cycle to achieve synchronization between the power supply of the external controller and the stimulation of the implantable neurostimulator.

[0012] The stimulation signal may have a preceding neural stimulation interval and a following non-neural stimulation interval in each stimulation cycle. The neural stimulation interval may include a forward stimulation interval for generating a positive current pulse, a reverse stimulation interval for generating a negative current pulse, and a transition interval located between the forward stimulation interval and the reverse stimulation interval. The pulse amplitude of the positive current pulse and the negative current pulse represents the stimulation intensity of the stimulation signal, the duration of the neural stimulation interval represents the effective stimulation time, and the sum of the durations of the neural stimulation interval and the non-neural stimulation interval represents the stimulation cycle.

[0013] The duty cycle can be set to be greater than the ratio of the effective stimulus time to the stimulus period, and the difference between the duty cycle and the ratio of the effective stimulus time to the stimulus period can be related to the ratio of the effective stimulus time to the stimulus period and / or the stimulus intensity. For the same ratio of the effective stimulus time to the stimulus period, the greater the stimulus intensity, the greater the difference between the duty cycle and the ratio of the effective stimulus time to the stimulus period. For the same stimulus intensity, the smaller the ratio of the effective stimulus time to the stimulus period, the greater the difference between the duty cycle and the ratio of the effective stimulus time to the stimulus period.

[0014] The energy supply cycle is equal to the stimulation cycle, and each energy supply cycle can begin earlier than the corresponding stimulation cycle.

[0015] The control method of the implantable neurostimulator system may further include: acquiring the maximum and minimum voltages of the stimulation signal and / or the average current in the positive and negative stimulation regions by an external controller, in order to adjust the output power of the external controller.

[0016] The present invention adopts the above technical solution and has the following beneficial effects: The external controller in the present invention adopts a duty cycle power supply method, and the stimulation signal generated by the implantable neurostimulator adopts a phase synchronized with the energy supply of the external controller. This fundamentally solves the serious overheating problem of the external controller and the implantable neurostimulator in the implantable neurostimulator system, greatly reduces energy waste, enhances the endurance of the implantable neurostimulator system, and thus ensures the long-term and continuous operation of the implantable neurostimulator system, guaranteeing the continuous therapeutic effect on the patient, and avoiding potential harm to the patient due to the increased temperature of the external controller and the implantable neurostimulator. In addition, the present invention collects the maximum and minimum voltage of the stimulation signal during voltage measurement and the average current of the stimulation signal in the positive and negative stimulation ranges during current measurement. Using these collected voltage and / or current information, the output power of the external controller can be adjusted, further saving energy. Attached Figure Description

[0017] The exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. For clarity, the same components in different drawings are shown with the same reference numerals. It should be noted that the drawings are for illustrative purposes only and are not necessarily drawn to scale. In these drawings:

[0018] Figure 1 This is a schematic diagram of an electrode implanted in a patient's body.

[0019] Figure 2 This is a schematic diagram of the stimulation signals generated by an implanted neurostimulator.

[0020] Figure 3 This is a schematic diagram of the power supply method of an external energy controller transmitting energy at a specific duty cycle according to an embodiment of the present invention, and the stimulation method of an implantable neurostimulator. Detailed Implementation

[0021] The following provides a detailed description of the embodiments of the present invention. These embodiments are implemented based on the technical solution of the present invention, and provide detailed implementation methods and specific operation processes. However, the scope of protection of the present invention is not limited to the following embodiments.

[0022] According to various embodiments of the present invention, an implantable neurostimulator receives an input signal including energy and control information from an external controller. The implantable neurostimulator includes a neurostimulation chip and electrodes. On one hand, the neurostimulation chip generates a stimulation signal having a stimulation period, effective stimulation time, and stimulation intensity based on the resolved control information, and distributes the stimulation signal to specific electrodes for application to the patient's treatment site.

[0023] Figure 1This is a schematic diagram of an electrode implanted in a patient's body. (For example...) Figure 1 As shown, at least one electrode is placed on the nerve 10 to be stimulated. Current can be output from either electrode or input to either electrode, with a "+" sign indicating output current and a "-" sign indicating input current. For example, Figure 1 The current in the electrode is output from electrode 8 and input to electrode 5. When current is input to or output from the electrode, the current intensity is generated on the electrode and stimulates the corresponding part of the nerve 10. In addition, electric field lines originate from electrode 8, diverge, and converge to reach electrode 5. Figure 1 The electric field lines shown are directed from right to left, resulting in a positive current pulse. Conversely, when the electric field lines are directed from left to right, a negative current pulse is formed.

[0024] In the stimulation control process, a cycle of positive and negative current pulses needs to be completed on two specific electrodes to ensure that each electrode involved in stimulation can achieve charge balance in this cycle, that is, the number of charges output by the electrode is equal to the number of charges input, thereby greatly reducing the electrochemical corrosion of the electrodes.

[0025] Figure 2 This is a schematic diagram of the stimulation signals generated by the neurostimulation chip in an implantable neurostimulator. (Example) Figure 2 As shown, the stimulation signal has a preceding neural stimulation zone and a following non-neural stimulation zone within each stimulation cycle. The neural stimulation zone includes: a forward stimulation zone for generating positive current pulses between specific electrodes (e.g., electrodes 8 and 5), a reverse stimulation zone for generating negative current pulses between specific electrodes (e.g., electrodes 8 and 5), and a transition zone between the forward and reverse stimulation zones.

[0026] Nerve stimulation is pulsed, not continuous electrical stimulation. Pulsed stimulation is necessary to relieve pain; continuous electrical stimulation not only has limited therapeutic effect but may also damage nerve tissue. Furthermore, in the nerve stimulation zone, the implanted neurostimulator generates current pulses between electrodes, consuming a significant amount of energy, while in the non-nerve stimulation zone, the implanted neurostimulator consumes only a very low quiescent current, typically below 100uA.

[0027] On the other hand, after the neurostimulation chip detects that the external controller is in a powered state, it generates a stimulation signal. In existing technologies, the external controller continuously sends energy, i.e., it is in a powered state. With the external controller providing continuous power for extended periods, most of the energy acquired by the implantable neurostimulator in the non-nerve stimulation zone is converted into heat and wasted. This is the fundamental reason for the severe overheating of implantable neurostimulators. The smaller the proportion of time spent in the non-nerve stimulation zone, the larger the stimulation current, and the more severe the overheating of the implantable neurostimulator. The prolonged continuous power supply also directly causes overheating of the external controller; the larger the stimulation current, the higher the output power of the external controller, and the more severe the overheating. The high power consumption, severe overheating, and short battery life of the external controller, along with the severe overheating of the implantable neurostimulator, can seriously affect treatment efficacy and even cause irreversible damage to the patient.

[0028] To avoid excessive heat generation in external controllers and implantable neurostimulators, and the resulting short battery life, existing implantable neurostimulation systems generally employ optimized heat dissipation schemes for external controllers, increased battery capacity, and intermittent stimulation. However, these solutions do not fundamentally solve the problem, and the intermittent stimulation method (i.e., alternating between stimulating and de-stimulating) significantly reduces the therapeutic effect and cannot help patients achieve sustained pain relief.

[0029] To address the aforementioned issues, in an embodiment of the present invention, the external energy controller does not continuously transmit energy, but rather transmits energy with a specific duty cycle.

[0030] However, under special circumstances, during the initial power supply period after the external controller is activated, the external controller continues to send energy to maintain the stimulation signal configured in the implanted neurostimulator. Subsequently, in each power supply cycle after the initial power supply period, the external controller can send energy at a specific duty cycle.

[0031] Figure 3 This is a schematic diagram of the power supply method of an external energy controller transmitting energy at a specific duty cycle according to an embodiment of the present invention, and the stimulation method of an implantable neurostimulator.

[0032] like Figure 3As shown, the power supply cycle of the external controller corresponds one-to-one with the stimulation cycle of the implanted neurostimulator to achieve synchronization between the power supply of the external controller and the stimulation of the implanted neurostimulator. For example, the power supply cycle |T1T3| corresponds to the stimulation cycle |T5T7|, and the power supply cycle is equal to the stimulation cycle, i.e., |T1T3|=|T5T7|. In an exemplary embodiment of the present invention, each power supply cycle begins earlier than the corresponding stimulation cycle, that is, the start time T1 of the power supply cycle is less than the start time T5 of the corresponding stimulation cycle, and correspondingly, the end time T3 of the power supply state is less than the end time T7 of the corresponding stimulation cycle.

[0033] Furthermore, the external energy controller can transmit energy at a specific duty cycle within one power supply cycle (i.e., |T1T3|). In this paper, the duty cycle refers to the ratio of the duration of energy transmission by the external energy controller to the entire power supply cycle, i.e., |T1T2| / |T1T3|.

[0034] Time point T2 represents the point in time when the external energy controller stops transmitting energy within one energy supply cycle, and its position also determines the duty cycle. According to an embodiment of the present invention, the duty cycle is determined by the stimulation period, effective stimulation time, and stimulation intensity of the stimulation signal. Combined with... Figure 2 and Figure 3 The amplitudes of the positive and negative current pulses are equal and represent the stimulation intensity of the stimulus signal. The sum of the durations of the neural stimulation interval and the non-neural stimulation interval represents the stimulation period (e.g., |T5T7|). The duration of the positive stimulation interval is equal to the duration of the negative stimulation interval and represents the pulse width; the duration of the neural stimulation interval (e.g., |T5T6|) represents the effective stimulation time.

[0035] Specifically, the duty cycle is set to be greater than the ratio of the effective stimulus time to the stimulus cycle. Furthermore, the difference between the duty cycle and the ratio of the effective stimulus time to the stimulus cycle is related to the ratio of the effective stimulus time to the stimulus cycle and / or the stimulus intensity.

[0036] Table 1 shows multiple sets of duty cycle data corresponding to the effective stimulation time, stimulation period, and stimulation intensity of the stimulus signal.

[0037] Table 1

[0038]

[0039] As shown in the first and second sets of data in Table 1, the ratio of effective stimulation time to stimulation cycle is 10% in both cases. Therefore, the duty cycle in the first and second sets of data is set to be greater than 10%.

[0040] When the ratio of effective stimulation time to stimulation cycle is the same in both the first and second sets of data, the stimulation intensity is 2 mA in the first set and 3 mA in the second set. If the stimulation intensity is greater, the energy supply time should be slightly longer. Therefore, the difference between the duty cycle and the ratio of effective stimulation time to stimulation cycle in the first set of data (i.e., 1%) is smaller than the difference between the duty cycle and the ratio of effective stimulation time to stimulation cycle in the second set of data (i.e., 3%).

[0041] In other words, given the same ratio of effective stimulation time to stimulation cycle, the greater the stimulation intensity, the greater the difference between the duty cycle and the ratio of effective stimulation time to stimulation cycle.

[0042] As shown in the third and fourth sets of data in Table 1, the ratio of effective stimulation time to stimulation cycle in the third set of data is 20%, and the ratio in the fourth set of data is 2%. Therefore, the duty cycle in the third set of data is set to be greater than 20%, and the duty cycle in the fourth set of data is set to be greater than 2%.

[0043] With the same stimulus intensity in the third and fourth data sets, the ratio of effective stimulus time to the stimulus cycle was 20% in the third data set and 2% in the fourth data set. A smaller ratio of effective stimulus time to the stimulus cycle indicates a longer stimulation period. In the third data set, the ratio of effective stimulus time to the stimulus cycle was 20%, the duty cycle was 21%, and the difference between the duty cycle and the ratio of effective stimulus time to the stimulus cycle was 1%. In the fourth data set, the ratio of effective stimulus time to the stimulus cycle was 2%, the duty cycle was 6%, and the difference between the duty cycle and the ratio of effective stimulus time to the stimulus cycle was 4%. Because the ratio of effective stimulus time to the stimulus cycle was smaller in the fourth data set, the duty cycle of the fourth data set was significantly increased relative to the ratio of effective stimulus time to the stimulus cycle.

[0044] In other words, for the same stimulus intensity, the smaller the ratio of effective stimulus time to stimulus cycle, the greater the difference between duty cycle and the ratio of effective stimulus time to stimulus cycle.

[0045] According to an embodiment of the present invention, by using a duty cycle power supply method in the external energy controller and by using a phase synchronized with the energy supply of the external energy controller in the stimulation signal generated by the implantable neurostimulator, it is ensured that the implantable neurostimulator has sufficient energy supply in the nerve stimulation zone and avoids excessive energy accumulation in the non-nerve stimulation zone, thereby effectively curbing the temperature rise of the external energy controller and the implantable neurostimulator.

[0046] In a preferred embodiment of the present invention, the external controller can acquire the maximum and minimum voltage of the stimulation signal. These two values—maximum and minimum voltage—of the implantable neurostimulator during stimulation can be used to adjust and evaluate whether the energy or power output by the external controller is reasonable. When the maximum and minimum voltage values ​​meet a certain range, the implantable neurostimulator can output a preset stimulation signal (i.e., a pulse waveform). If the maximum or minimum voltage value is too high, it indicates energy waste; if the maximum value is too low, the output pulse amplitude may be lower than expected; if the minimum value is too low, the implantable neurostimulator may reset and stop working due to interference or other factors. Therefore, by comparing the maximum and minimum voltage values ​​to adjust the output mode of the external controller, energy saving can be further achieved.

[0047] In another preferred embodiment of the invention, the external controller can collect the average current of the stimulation signal in the forward and reverse stimulation regions to determine whether the actual stimulation current intensity is consistent with the expectation. If it is lower than the expected value, it indicates that the current power supply voltage of the implantable neurostimulator is too low, and the output power of the external controller should be increased.

[0048] Furthermore, the aforementioned first and second preset thresholds can be values ​​derived from voltage and current values ​​collected by technicians after multiple tests.

[0049] This invention also provides a control method for an implantable neurostimulator system. The implantable neurostimulator system includes an external controller and an implantable neurostimulator. The control method includes: the external controller sending an input signal containing energy and control information to the implantable neurostimulator; the implantable neurostimulator maintaining operation based on the received energy and forming a stimulation signal with effective stimulation time, stimulation cycle, and stimulation intensity for application to the patient's treatment site based on the received control information; the external controller continuously sending energy during the initial power supply period after startup to maintain the stimulation signal configured in the implantable neurostimulator; and the external controller sending energy at a specific duty cycle in each power supply cycle after the initial power supply period, the duty cycle being determined by the effective stimulation time, stimulation cycle, and stimulation intensity of the stimulation signal, with each power supply cycle corresponding to a stimulation cycle to achieve synchronization between the power supply from the external controller and the stimulation from the implantable neurostimulator.

[0050] Specifically, the stimulation signal has a preceding neural stimulation zone and a following non-neural stimulation zone in each stimulation cycle. The neural stimulation zone includes a forward stimulation zone for generating positive current pulses, a reverse stimulation zone for generating negative current pulses, and a transition zone between the forward and reverse stimulation zones. In this case, the pulse amplitudes of the positive and negative current pulses represent the stimulation intensity of the stimulation signal, the duration of the neural stimulation zone represents the effective stimulation time, and the sum of the durations of the neural and non-neural stimulation zones represents the stimulation cycle.

[0051] As mentioned above, the duty cycle is determined by the effective stimulation time, stimulation period, and stimulation intensity of the stimulus signal. Specifically, the duty cycle is set to be greater than the ratio of the effective stimulation time to the stimulation period, and the difference between the duty cycle and the ratio of the effective stimulation time to the stimulation period is related to the ratio of the effective stimulation time to the stimulation period and / or the stimulation intensity. This correlation can be manifested as follows: for the same ratio of the effective stimulation time to the stimulation period, the greater the stimulation intensity, the greater the difference between the duty cycle and the ratio of the effective stimulation time to the stimulation period; for the same stimulation intensity, the smaller the ratio of the effective stimulation time to the stimulation period, the greater the difference between the duty cycle and the ratio of the effective stimulation time to the stimulation period.

[0052] The energy supply cycle corresponds one-to-one with the stimulation cycle. Specifically, the energy supply cycle is equal to the stimulation cycle, and each energy supply cycle begins earlier than the corresponding stimulation cycle.

[0053] The control method of the implantable neurostimulator system may further include: acquiring the maximum and minimum voltages of the stimulation signal and / or the average current in the positive and negative stimulation regions by an external controller, in order to adjust the output power of the external controller.

[0054] In the implantable neurostimulator system and its control method according to an embodiment of the present invention, the external controller adopts a duty cycle power supply mode, and the stimulation signal generated by the implantable neurostimulator adopts a phase synchronized with the energy supply of the external controller. This can fundamentally solve the serious problem of overheating of the external controller and the implantable neurostimulator in the implantable neurostimulator system, greatly reduce the energy waste of the implantable neurostimulator system, enhance the endurance of the implantable neurostimulator system, thereby ensuring the long-term and continuous operation of the implantable neurostimulator system, ensuring the continuous therapeutic effect on the patient, and avoiding the possible harm to the patient caused by the temperature rise of the external controller and the implantable neurostimulator.

[0055] Furthermore, the implantable neurostimulator system and its control method according to embodiments of the present invention acquire the maximum and minimum voltage of the stimulation signal during voltage measurement, and acquire the average current of the stimulation signal in the positive and negative stimulation intervals during current measurement. The output power of the external energy controller can be adjusted using these acquired voltage and / or current information, thereby further saving energy.

[0056] The various embodiments of the present invention are not an exhaustive list of all possible combinations, but are intended to describe representative aspects of the invention, and the contents described in the various embodiments can be applied independently or in two or more combinations.

[0057] The description of the exemplary embodiments presented above is merely illustrative of the technical solutions of the present invention and is not intended to be exhaustive, nor is it intended to limit the invention to the precise forms described. Obviously, those skilled in the art can make many changes and variations based on the above teachings. The exemplary embodiments were chosen and described to explain the specific principles of the invention and its practical applications, thereby enabling others skilled in the art to understand, implement, and utilize the various exemplary embodiments of the invention and their various alternatives and modifications. The scope of protection of the present invention is intended to be defined by the appended claims and their equivalents.

Claims

1. An implantable neurostimulator system comprising an external controller and an implantable neurostimulator, wherein the external controller sends an input signal including energy and control information to the implantable neurostimulator, the implantable neurostimulator maintains operation according to the received energy, and forms a stimulation signal with stimulation period, effective stimulation time and stimulation intensity for application to a treatment site of a patient according to the received control information; in, The external energy controller is configured as follows: Energy is continuously delivered during the initial power supply period after startup to maintain the stimulation signal configured in the implantable neurostimulator; Energy is delivered at a specific duty cycle in each energy supply cycle after the initial energy supply period. The duty cycle is determined by the stimulation cycle, effective stimulation time and stimulation intensity of the stimulation signal, and the energy supply cycle corresponds one-to-one with the stimulation cycle to achieve synchronization between the energy supply of the external energy controller and the stimulation of the implanted neurostimulator.

2. The implantable neurostimulator system according to claim 1, wherein, The stimulation signal has a preceding neural stimulation interval and a following non-neural stimulation interval in each stimulation cycle. The neural stimulation interval includes a positive stimulation interval for generating a positive current pulse, a reverse stimulation interval for generating a negative current pulse, and a transition interval located between the positive stimulation interval and the reverse stimulation interval. The pulse amplitudes of positive and negative current pulses represent the stimulation intensity of the stimulation signal, the duration of the neural stimulation interval represents the effective stimulation time, and the sum of the durations of the neural stimulation interval and the non-neural stimulation interval represents the stimulation period.

3. The implantable neurostimulator system according to claim 2, wherein, The external energy controller is configured as follows: The duty cycle is set to be greater than the ratio of the effective stimulus time to the stimulus cycle, and the difference between the duty cycle and the ratio of the effective stimulus time to the stimulus cycle is related to the ratio of the effective stimulus time to the stimulus cycle and / or the stimulus intensity. Given the same ratio of effective stimulation time to stimulation cycle, the greater the stimulation intensity, the greater the difference between the duty cycle and the ratio of effective stimulation time to stimulation cycle. For the same stimulus intensity, the smaller the ratio of effective stimulus time to stimulus cycle, the greater the difference between duty cycle and the ratio of effective stimulus time to stimulus cycle.

4. The implantable neurostimulator system according to claim 1, wherein, The energy supply cycle is equal to the stimulation cycle, and each energy supply cycle begins earlier than the corresponding stimulation cycle.

5. The implantable neurostimulator system according to claim 1, wherein, The external energy controller is configured as follows: The maximum and minimum voltages of the stimulation signal, and / or the average current in the positive and negative stimulation regions, are collected to adjust the output power of the external energy controller.

6. A control method for an implantable neurostimulator system, the implantable neurostimulator system comprising an external controller and an implantable neurostimulator, the control method comprising: An external energy controller sends an input signal containing energy and control information to an implantable neurostimulator; The implantable neurostimulator maintains operation based on the received energy and generates a stimulation signal with stimulation period, effective stimulation time and stimulation intensity for application to the patient's treatment site based on the received control information; An external energy controller continuously delivers energy during the initial power supply period after activation to maintain the stimulation signal configured in the implantable neurostimulator. An external energy controller sends energy at a specific duty cycle in each energy supply cycle after the initial energy supply period. The duty cycle is determined by the stimulation cycle, effective stimulation time, and stimulation intensity of the stimulation signal. The energy supply cycle corresponds one-to-one with the stimulation cycle to achieve synchronization between the energy supply from the external energy controller and the stimulation from the implanted neurostimulator.

7. The control method for the implantable neurostimulator system according to claim 6, wherein: The stimulation signal has a preceding neural stimulation zone and a following non-neural stimulation zone in each stimulation cycle. The neural stimulation zone includes a positive stimulation zone for generating positive current pulses, a reverse stimulation zone for generating negative current pulses, and a transition zone located between the positive stimulation zone and the reverse stimulation zone. The pulse amplitudes of positive and negative current pulses represent the stimulation intensity of the stimulation signal, the duration of the neural stimulation interval represents the effective stimulation time, and the sum of the durations of the neural stimulation interval and the non-neural stimulation interval represents the stimulation period.

8. The control method for the implantable neurostimulator system according to claim 7, wherein: The duty cycle is set to be greater than the ratio of the effective stimulus time to the stimulus cycle, and the difference between the duty cycle and the ratio of the effective stimulus time to the stimulus cycle is related to the ratio of the effective stimulus time to the stimulus cycle and / or the stimulus intensity. Given the same ratio of effective stimulation time to stimulation cycle, the greater the stimulation intensity, the greater the difference between the duty cycle and the ratio of effective stimulation time to stimulation cycle. For the same stimulus intensity, the smaller the ratio of effective stimulus time to stimulus cycle, the greater the difference between duty cycle and the ratio of effective stimulus time to stimulus cycle.

9. The control method for the implantable neurostimulator system according to claim 6, wherein, The energy supply cycle is equal to the stimulation cycle, and each energy supply cycle begins earlier than the corresponding stimulation cycle.

10. The control method for the implantable neurostimulator system according to claim 6, further comprising: The maximum and minimum voltages of the stimulation signal, and / or the average current in the positive and negative stimulation regions, are collected by the external controller to adjust the output power of the external controller.

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