Nerve stimulation device

Abstract

The invention relates to the field of medical instruments, and discloses a nerve stimulation device, which comprises a control module, a pulse issuing module and a sensing module, and is characterized in that the pulse issuing module is used for issuing pulses according to instructions; the sensing module is used for starting sensing of the evoked composite action potential according to the instruction; the control module is used for instructing to start the sensing module while instructing to issue the pulse; after the instruction issues the stimulation pulse, after sensing delay time, instructing sensing to induce a composite action potential; the instruction sensing module is closed after the ECAP window time after the instruction senses and induces the composite action potential; wherein the sensing delay time is the maximum value between the total pulse duration and the module conversion time. The sensing module is selectively started to sense the evoked composite action potential, so that the power consumption of the sensing module is reduced, and a good foundation is laid for reducing the size of the nerve stimulation device and prolonging the charging interval of the device.

Description

[0001] This application is a divisional application of a patent application with application date of August 18, 2021, application number 202110950387.7, and invention name “Neurostimulation device, neurostimulation system, electronic device and storage medium”. Technical Field

[0002] The embodiments of the present application relate to the field of medical devices, and in particular to a nerve stimulation device. Background Art

[0003] With the progress and development of science and technology, the technology of controlling and treating diseases by sending nerve stimulation has gradually matured. The so-called closed-loop function in nerve stimulation can measure the response of the organ affected by nerve stimulation to the stimulation, and then adjust the pulse to achieve better therapeutic effect. The evoked compound action potential (ECAP) is the external manifestation of the fiber population's response to electrical stimulation. Clinical studies have shown new scientific evidence to support the closed-loop spinal cord stimulation (SCS) system for the treatment of chronic pain based on feedback control of ECAP. During spinal cord stimulation, ECAP can be sensed, and the relationship between pulse stimulation, electrophysiological response and neuromodulation can be obtained based on the sensing results. Therefore, major SCS manufacturers are implementing this new function into the next generation of SCS systems to achieve the closed-loop function in spinal cord stimulation. That is, the spinal cord's response to stimulation, that is, the evoked compound action potential, is sensed, and the pulse duration, pulse intensity, pulse interval, etc. are adjusted based on the sensed ECAP results to optimize the activation within the patient's treatment window and maintain the long-term therapeutic effect of stimulation.

[0004] Existing neurostimulation devices generally have multiple stimulation electrodes (8-16 contacts or more), and the power consumption of neurostimulation devices is already relatively high. In order to achieve pulse adjustment based on the sensing results of ECAP, it is necessary to add an ECAP sensing function module to the neurostimulation device. The newly added ECAP sensing function module will further increase the power consumption of the entire device. Reducing power consumption is very necessary to reduce the size of the IPG (implanted neurostimulation device) and extend the battery charging interval of the device. The additional high power consumption brought by the newly added ECAP sensing function module will cause great trouble to reducing the size of the IPG and increasing the charging interval of the device. Summary of the invention

[0005] The embodiment of the present invention aims to provide a neural stimulation device, which starts sensing of induced compound action potentials at a fixed time interval after a sensing delay time after pulse emission, and uses a method of selectively turning on the sensing module to sense the induced compound action potential, thereby reducing the power consumption of the sensing module and minimizing the overall power consumption of the neural stimulation device, laying a good foundation for reducing the size of the neural stimulation device and extending the charging interval of the device.

[0006] To achieve the above-mentioned purpose, an embodiment of the present application provides a neural stimulation device, including: a control module, a pulse emission module and a sensing module; the pulse emission module is used to emit pulses according to the instructions of the control module; the sensing module is used to start sensing of induced compound action potentials according to the instructions of the control module; the control module is used to instruct the sensing module to be turned on while instructing the pulse emission module to emit pulses; after the sensing delay time has passed after the pulse emission module is instructed to emit stimulation pulses, the sensing module is instructed to sense the induced compound action potential; after the ECAP window time has passed after the sensing module is instructed to sense the induced compound action potential, the sensing module is instructed to be turned off; wherein the sensing delay time is the maximum value between the total duration of the pulse and the preset module switching time; the total duration of the pulse includes the pulse duration and the sensing refractory period, the pulse duration includes the main pulse time of the pulse, the recovery / charge balance pulse time and the interval time between the main pulse time and the recovery / charge balance pulse time, and the module switching time is expressed as the duration of module switching in the neural stimulation device.

[0007] In the neural stimulation device proposed in the present application, the control module instructs the sensing module to turn on when the command pulse is sent, and after the sensing delay time has passed, the control module instructs the sensing module to start sensing of the induced compound action potential, and after the sensing of the induced compound action potential is turned on and reaches the ECAP window time, the sensing module is controlled to turn off. Therefore, the neural stimulation device of the present application pre-sets the duration of each stage in the sensing process of the induced compound action potential through the sensing delay time from the pulse issuance to the start of sensing and the ECAP window time of the sensing duration of the induced compound action potential, controls the sensing of the induced compound action potential to be completed at a fixed time within a specified time period, ensures the accuracy of the sensing result of the induced compound action potential, and avoids the long-term opening of the sensing unit for sensing the induced compound action potential, thereby reducing the overall power consumption of the neural stimulation device as much as possible, and can lay a good foundation for reducing the design size of the neural stimulation device and extending the charging interval. BRIEF DESCRIPTION OF THE DRAWINGS

[0008] One or more embodiments are exemplarily described by pictures in the corresponding drawings, and these exemplified descriptions do not constitute limitations on the embodiments. Elements with the same reference numerals in the drawings represent similar elements, and unless otherwise stated, the figures in the drawings do not constitute proportional limitations.

[0009] Figure 1 is a schematic diagram of the structure of a nerve stimulation device according to an embodiment of the present application;

[0010] Figure 2 is a schematic diagram of the working timing of the spinal cord electrical stimulation device according to an embodiment of the present application;

[0011] Figure 3 is another working timing diagram of the spinal cord electrical stimulation device according to an embodiment of the present application;

[0012] Figure 4 is another working timing diagram of the spinal cord electrical stimulation device according to an embodiment of the present application;

[0013] Figure 5 is a schematic structural diagram of a neural stimulation system according to another embodiment of the present application;

[0014] Figure 6 It is a schematic diagram of the structure of an electronic device according to another embodiment of the present application. DETAILED DESCRIPTION

[0015] As can be seen from the background technology, the existing neurostimulation device has multiple stimulation electrodes (8-16 contacts or more). In order to maintain the effectiveness of each electrode, the power consumption of the neurostimulation device is relatively high. In order to achieve pulse adjustment according to the sensing results of ECAP, the newly added sensing module will further increase the overall power consumption of the neurostimulation device, which will cause troubles in reducing the size of the neurostimulation device and extending the charging interval. Therefore, how to provide a neurostimulation device that can obtain ECAP sensing results with low power consumption for pulse adjustment is an urgent problem that needs to be solved.

[0016] In order to solve the above problems, an embodiment of the present application provides a neural stimulation device, including: a control module, a pulse emission module and a sensing module; the pulse emission module is used to emit pulses according to the instructions of the control module; the sensing module is used to start sensing of induced compound action potentials according to the instructions of the control module; the control module is used to instruct the sensing module to turn on when instructing the pulse emission module to emit pulses; after the sensing delay time has passed after the pulse emission module is instructed to emit a stimulation pulse, the sensing module is instructed to sense the induced compound action potential; after the ECAP window time has passed after the sensing module is instructed to sense the induced compound action potential, the sensing module is instructed to turn off; wherein the sensing delay time is the maximum value between the total duration of the pulse and the preset module conversion time.

[0017] In the neural stimulation device provided in the embodiment of the present application, the control module instructs the sensing module for sensing the induced compound action potential to turn on while instructing the pulse to be issued, instructs the sensing module to sense the induced compound action potential after the sensing delay time, and instructs the sensing module to turn off after the ECAP window time. Therefore, the neural stimulation device provided in the embodiment of the present application pre-sets the duration of each stage in the induced compound action potential sensing process through the sensing delay time from the pulse issuance to the start of sensing and the ECAP window time of the induced compound action potential sensing duration, controls the sensing of the induced compound action potential to be completed at a fixed time within a specified time period, ensures the accuracy of the induced compound action potential sensing result, avoids the long-term opening of the sensing unit for sensing the induced compound action potential, and reduces the overall power consumption of the neural stimulation device as much as possible, laying a good foundation for reducing the design size of the neural stimulation device and extending the charging interval.

[0018] To make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the embodiments of the present application will be described in detail below in conjunction with the accompanying drawings. However, it will be appreciated by those skilled in the art that in the present application, many technical details are proposed in order to enable the reader to better understand the present application. However, even without these technical details and various changes and modifications based on the following embodiments, the technical scheme claimed in the present application can also be implemented. The division of the following embodiments is for the convenience of description, and the specific implementation of the present application should not be construed as any limitation, and the various embodiments can be combined and referenced with each other under the premise of no contradiction.

[0019] The implementation details of the neural stimulation device described in this application will be specifically described below in conjunction with specific embodiments. The following content is only the implementation details provided for easy understanding and is not essential for this solution.

[0020] A first aspect of an embodiment of the present invention provides a neural stimulation device that can be used in a variety of neural stimulation scenarios, such as spinal cord stimulation (SCS), dorsal root ganglion stimulation (DRG), sympathetic nerve stimulation (SNS), vagus nerve stimulation (VNS), deep brain stimulation (DBS), etc. This embodiment is described by using the spinal cord stimulation scenario.

[0021] like Figure 1 As shown, an embodiment of the present invention provides a nerve stimulation device, comprising:

[0022] The control module 101 is used to instruct the sensing module to turn on when the pulse emission module is instructing the pulse emission module to emit a pulse; after the sensing delay time has passed after the pulse emission module is instructing the pulse emission module to emit a stimulation pulse, the sensing module is instructing the sensing module to sense the induced compound action potential; after the ECAP window time has passed after the sensing module is instructing the sensing module to turn off; wherein the sensing delay time is the maximum value between the total duration of the pulse and the preset module conversion time.

[0023] The pulse issuing module 102 is used to issue pulses according to the instructions of the control module.

[0024] The sensing module 103 is used to start sensing of evoked compound action potentials according to the instruction of the control module.

[0025] In practical applications, there are many options for the selection of control modules, including: logic circuit, MCU, CPU, microprocessor, PLC, FPGA, PAL, GAL, CPLD, any one or any combination thereof. This embodiment does not limit the specific selection of the control module.

[0026] Specifically, before being implanted in the user's body, the spinal cord electrical stimulation device can pre-set or store various pulse and sensing related parameters, such as pulse frequency, pulse intensity, pulse release cycle, pulse duration, evoked compound action potential sensing time (i.e., ECAP window time), etc. Figure 2 As shown, the control module obtains the pulse emission period T according to the inverse of the initial pulse emission frequency f, and sends a pulse emission instruction to the pulse emission module. The pulse emission module sends the specified pulse according to the above pulse emission instruction, and then sends a new pulse emission instruction to the pulse emission module after the duration of the period T'; wherein, the preferred period of pulse emission is generally greater than 6.67ms (the corresponding pulse emission frequency is 150Hz), and the initial pulse emission period exemplified here is 20ms (the corresponding pulse emission frequency is 50Hz). In a closed-loop system, the current period T may be the same as or different from the next period T'. While the instruction pulse emission module emits a pulse, the control module sends a module opening instruction to the sensing module, and the sensing module is triggered to turn on. After the instruction pulse is emitted and the sensing delay time has passed, the control module sends a sensing opening instruction to the sensing module, and the sensing module starts sensing the induced compound action potential according to the above sensing opening instruction. After the instruction sensing module senses the induced compound action potential and the ECAP window time has passed, the sensing module sends a module closing instruction to the sensing module, and the sensing module enters the closed state according to the above module closing instruction.

[0027] The sensing delay time is the maximum value between the total duration of the pulse and the preset module switching time. A parameter t that can be adjusted by programming is stored in the control module of the neural stimulation device. sw , t sw It is a time-related parameter, which is related to the hardware of the neurostimulator and is used to identify the duration of module switching in the neurostimulator. The total duration of a pulse includes the pulse duration and the sensing refractory period. Among them, the pulse duration includes the main pulse time (primary stimulation pulse), the recovery / charge balance pulse time (recover / charge balance pulse) and the interval time between the main pulse time and the recovery / charge balance pulse time; the sensing refractory period is the duration set to avoid the influence of circuit discharge and hardware oscillation on sensing, and the sensing refractory period is related to the hardware of the neurostimulator. In order to meet the dual requirements of sensing accuracy and minimizing power consumption, the sensing delay time of induced compound action potential sensing needs to consider the total duration of the pulse and the preset module conversion time at the same time. Compared with the neurostimulator in which the sensing module is always sensing, the power consumption of the neurostimulator in this embodiment can be as low as about one-fourth of the former when applied to spinal cord electrical stimulation (pulses are emitted at a frequency of 50Hz).

[0028] After the control module instructs the sensing module to start, it needs to determine the time for instructing the sensing module to start sensing and stimulating compound action potentials, that is, the sensing delay time. sw When (module switching time) is greater than or equal to the total duration of the pulse consisting of the pulse duration and the sensing blank period, the control module directly sets t sw As the sensing delay time; if the parameter t sw When the total duration of the pulse is less than the total duration of the pulse composed of the pulse duration and the sensing blank time, the control module uses the total duration of the pulse as the sensing delay time. By setting the sensing delay time to the maximum value between the total duration of the pulse and the module switching time, it is avoided to start the evoked compound action potential sensing during the period when the evoked compound action potential cannot be effectively sensed, and the power consumption of the spinal cord electrical stimulation device is reduced as much as possible.

[0029] Further, the neurostimulation device also includes one or more timing modules. The timing module has a timing mode, which is used to ensure that a specific action can occur on time. In addition, the timing module may also have other functions, such as a timing mode, which is used to record the real time when a specific action or signal occurs. In a specific example, the neurostimulation device includes a first timing module, a second timing module and a third timing module. The first timing module is configured as a timing mode, and the timing duration is the duration of the pulse emission cycle. When the pulse emission cycle expires and the first timing module overflows, the control module instructs the sensing module to be turned on. In a preferred solution, the control module remains in a dormant state to further reduce power consumption. When the first timing module overflows, the control module is awakened by an interrupt. When the control module instructs the sensing module to be turned on, the second timing module is configured as a timing mode, and the timing duration is the duration of the sensing delay time. When the sensing delay time expires and the second timing module overflows, the control module instructs the sensing module to sense the induced compound action potential. When the control module instructs the sensing module to sense the induced compound action potential, the third timing module is configured as a timing mode, and the timing duration is the duration of the ECAP window time. When the ECAP window time expires and the third timing module overflows, the control module instructs the sensing module to shut down.

[0030] When the nerve stimulation device is working, if the pulse emission cycle expires and the first timing module overflows, the control module resets the first timing module and re-enters the timing mode. At the same time, the control module sends a pulse emission instruction to the pulse emission module to control the pulse emission module to emit a new pulse, and sends a module opening instruction to the sensing module to control the sensing module to turn on. At the same time, the control module turns on the second timing module, and the second timing module is also configured as a timing mode, and the timing duration is the duration of the sensing delay time. When the second timing module overflows, the control module determines that the sensing delay time has passed since the instruction pulse was emitted, and it is necessary to turn on the sensing of the induced compound action potential (ECAP sensing), so it sends a sensing opening instruction to the sensing module and turns off the second timing module. At the same time, the control module turns on the third timing module. The third timing module is also configured as a timing mode, and the timing duration is the duration of the ECAP window time. When the third timing module overflows, the control module determines that the sensing duration of the induced compound action potential has reached the preset ECAP window duration, so it sends a module closing instruction, and the third timing module and the sensing module are closed and enter the closed state.

[0031] In addition, the neurostimulation device also includes a sixth timing module for realizing pulse shutdown. Similar to other timing modules, the sixth timing module has a timing mode. When the first timing module overflows, the control module turns on the sixth timing module, and the timing duration is the pulse duration. When the pulse duration expires and the sixth timing module overflows, the control module sends a pulse stop instruction to the pulse issuing unit, and the pulse issuing unit stops issuing pulses according to the above instruction. The control module also turns off the sixth timing module accordingly.

[0032] In another example, the neurostimulation device can also be used for dorsal root ganglion electrical stimulation, sympathetic nerve electrical stimulation, vagus nerve electrical stimulation or deep brain electrical stimulation. When the neurostimulation device is used in different scenarios, the total duration of the pulse is adjusted according to specific needs, and the control module determines the new sensing delay time according to the total duration of the new pulse and the module conversion time. Therefore, on the basis of reducing the overall power consumption of the neurostimulation device, the accurate sensing of the induced compound action potential is guaranteed as much as possible, so that the pulse-related parameters can be adjusted according to the sensing results.

[0033] Furthermore, the control module is also used to determine whether it is necessary to sense the induced compound action potential before instructing the sensing module to start; if sensing is required, the sensing module is instructed to start, and then the sensing module is instructed to sense the induced compound action potential. In practical applications, in order to reduce power consumption, it is not necessary to sense the induced compound action potential in each pulse emission cycle. A cycle consisting of multiple pulse emission cycles can be set, and the induced compound action potential is sensed in some pulse emission cycles in the cycle, and the induced compound action potential is no longer sensed at other times in the cycle. In addition, in the event of an unexpected situation, such as when the battery is lower than a threshold, or when there is a problem with the sensing module, the control module can also determine not to sense the induced compound action potential.

[0034] In one example, the control module is used to determine whether it is necessary to sense the induced compound action potential, including obtaining the cumulative duration of the pulse emission period of the induced compound action potential that has been sensed in the current cycle, and if the cumulative duration is less than the preset first duration, it is determined that the induced compound action potential needs to be sensed; wherein the cycle includes at least two pulse emission periods. Figure 3As shown, in the control module of the nerve stimulation device for spinal cord electrical stimulation, the cycle of pulse release is pre-set, and the cumulative duration of the pulse release cycle of the induced compound action potential needs to be sensed in each cycle, that is, the first duration. Here, the cycle and the first duration can be set according to the user's physical condition, for example, the cycle is 1 minute, 3 minutes or 5 minutes. After the current cycle starts, the control module counts the cumulative duration of the pulse release cycle of the induced compound action potential sensing by the sensing module. When the cumulative duration of the pulse release cycle of the induced compound action potential that has been sensed in the current cycle does not reach the first duration, it means that the induced compound action potential needs to be sensed, the control module instructs the sensing module to turn on, and sends a control instruction to the sensing module after the sensing delay time, and senses the induced compound action potential according to the ECAP window time. After the cumulative duration reaches the first duration, it means that the induced compound action potential is no longer needed to be sensed in the subsequent pulse release cycle, and the control module no longer instructs the sensing module to turn on when the command pulse is released until the next cycle is entered.

[0035] More specifically, the nerve stimulation device includes a first timing module, a fourth timing module and a fifth timing module. When the cycle starts, the control module instructs to turn on the first timing module and the fourth timing module, the first timing module is configured as a timing mode, and the timing duration is the duration of the pulse emission cycle; the fourth timing module is configured as a timing mode, and the timing duration is the duration of the cycle. At the same time or after the cycle starts, the control module instructs to turn on the fifth timing module, and the fifth timing module is configured as a timing mode, and the timing duration is the first duration. When the fourth timing module does not overflow, the fifth timing module does not overflow, and the first timing module overflows, the control module determines that it is necessary to sense the induced compound action potential in this pulse cycle, and instructs to turn on the sensing module while instructing to emit pulses, and then instructs the sensing module to sense the induced compound action potential. At the same time, the control module instructs to reset the first timing module. When the fifth timing module overflows, sufficient induced compound action potential information has been obtained in this cycle, and the control module instructs to turn off the fifth timing module. When the fourth timing module overflows, the current cycle has ended, and the next cycle begins, and the control module instructs to reset the fourth timing module. In an alternative embodiment, the cycle period is described by the number of pulse emission periods rather than the duration, and similarly, the pulse emission period of the sensing module that has been used to sense the induced compound action potential is also described by the number rather than the duration. In this case, a counter is used to record the relevant quantity, for example, within the cycle period, when the first timing module overflows, the first counter is incremented by one, and when the sensing module senses the generation of the pulse emission period of the induced compound action potential, the second counter is incremented by one. This embodiment is a variation of the above embodiment and is also within the protection scope of the present invention.

[0036] In another alternative embodiment, when the cycle is counted by duration, in the case where the first duration and the cycle are started / ended synchronously, the parameter of the cumulative duration of the pulse emission cycle that does not sense the induced compound action potential in the pulse emission cycle (i.e., the blank sensing duration) and the parameter of the cumulative duration of the pulse emission cycle that allows the induced compound action potential sensing in the pulse emission cycle (i.e., the first duration) can also be used to achieve sensing of the induced compound action potential in part of the pulse emission cycle in a cycle, while the remaining pulse emission cycles are not sensed. At this time, the sum of the blank sensing duration and the first duration is a cycle. For example, at the beginning of a cycle, the fourth timing module is configured as a timing mode and starts timing, and the timing duration is the blank sensing duration. Before the fourth timing module overflows, the control module controls the third timing module and the sensing module to be in a closed state in each pulse emission cycle until the fourth timing module overflows. At this time, the control module instructs the fifth timing module to start, and configures the fifth timing module to the timing mode respectively, and the timing duration of the fifth timing module is the first duration. When the fifth timely module does not overflow, in each pulse emission cycle, the control module sends a module start instruction to the sensing module while sending a pulse emission instruction to the pulse emission module, and after the sensing delay time, instructs the sensing module to start sensing the induced compound action potential and starts sensing the induced compound action potential; when the fifth timing module overflows, the current cycle ends, the control module instructs the fourth timing module to reopen, the fifth timing module to close, and enters the next cycle. Among them, the settings of the two data of the blank sensing duration and the first duration can be set according to actual conditions. For example, when the neural stimulation device is used for setting the first duration for spinal cord electrical stimulation, the specific value of the first duration can be considered according to the user's breathing rhythm, and the specific value of the blank sensing duration can be set according to factors such as the user's living habits and physical fitness, which is not limited in this embodiment. By sensing the induced compound action potential in part of the pulse emission cycle in a cycle, while not sensing the remaining pulse emission cycles, the overall power consumption of the neural stimulation device is further reduced.

[0037] In another example, the accumulated duration of the pulse emission cycle of the sensing induced compound action potential of the nerve stimulation device, that is, the first duration is determined according to the vital sign parameters of the user, wherein the vital sign parameters include any one or any combination of the following: breathing rhythm, heart rate, blood pressure value. By combining the vital sign parameters of the user, the first duration that the nerve stimulation device needs to sense the induced compound action potential is set, and the overall energy consumption of the nerve stimulation device is reduced as much as possible on the basis of ensuring the effectiveness of sensing.

[0038] Furthermore, the neural stimulation device also includes: a human posture sensing module; a human posture sensing module for sensing the real-time posture of the human body; the control module is also used to communicate with the human posture sensing module to obtain the human posture. If a change in the human posture is detected within a cycle, a new cycle is started and the cumulative duration is reset to zero. For example, the neural stimulation device for spinal cord electrical stimulation enters the working state after setting the cycle, the first duration, the pulse emission cycle and other parameters. The control module obtains the cumulative duration of the pulse emission cycle that has been used to induce compound action potential sensing within the current cycle through the timing module, and obtains the user's real-time posture data through the posture sensor to detect whether the user's posture has changed. Within a cycle, if the cumulative duration has reached the first duration, then within the new pulse emission cycle, the control module no longer sends a module start instruction to the sensing module, and the sensing module remains in a closed state. At this time, if the control module detects that the user's posture has changed through the human posture sensor, then the control module interrupts the current cycle, and the next pulse emission cycle is regarded as the beginning of a new cycle, and the cumulative duration of the induced compound action potential sensing in the current cycle and the duration of the current cycle have been reset to zero, and the fourth timing module is controlled to reset and start a new timing. At the beginning of a pulse emission cycle in the new cycle, the control module sends a module start instruction to the sensing module while issuing the instruction pulse, and sends an opening instruction to the fifth timing module, and after the sensing delay time, instructs the sensing module to start sensing the induced compound action potential after the user's posture changes. If the cumulative duration is still less than the first duration at this time, that is, the induced compound action potential is still sensed in the pulse emission cycle, after completing this pulse emission cycle, similar to the above situation, the control module interrupts the current cycle, and the next pulse emission cycle is regarded as the beginning of a new cycle, and the cumulative duration of the induced compound action potential sensing in the current cycle and the duration of the current cycle have been reset to zero, and the fourth timing module is controlled to reset and start a new timing. The posture sensor monitors the user's posture changes, interrupts the current cycle in time, starts a new cycle, senses the evoked compound action potential after the user's posture changes, and obtains the user's response to the pulse after the posture change, so as to facilitate subsequent adjustment of the pulse according to the sensing results, avoiding the user's uncomfortable reaction to the pulse after the posture change.

[0039] Furthermore, the control module is also used to update the parameters of the pulse according to the evoked compound action potential information obtained by sensing, and send the updated pulse emission instruction to the pulse emission module in the next pulse emission cycle, and instruct the pulse emission module to adjust the subsequently sent pulses according to the updated pulse emission instruction. For example, in the control module of the neural stimulation device used for spinal cord electrical stimulation, according to the sensing result of the evoked compound action potential by the sensing module, one or more of the parameters such as the pulse duration, pulse intensity, pulse frequency, and pulse emission cycle are adaptively adjusted to determine a more suitable pulse. Then, the control module sends the updated pulse emission instruction to the pulse emission module in the next pulse emission cycle, and instructs the pulse emission module to emit pulses according to the updated pulse emission instruction. By adjusting the pulse parameters according to the sensing result of the evoked compound action potential, it is ensured that the user can achieve the most effective treatment effect for as long as possible under the action of the pulse.

[0040] In addition, the control module can send an updated pulse issuance instruction to the pulse issuance module based on the sensing results of the sensing module at the beginning of any pulse issuance cycle, or adjust the pulse parameters based on multiple sensing results obtained within the cycle after the end of a cycle, and send the updated pulse issuance instruction to the pulse issuance module at the beginning of the next cycle. This embodiment does not impose any restrictions on this.

[0041] The pulse emission modes of the neural stimulation device in this embodiment include the tonic spiking emission mode (also known as the forced discharge mode, Tonic Spiking) and the tonic burst emission mode (Tonic Bursting). In the tonic peak emission mode, the control module emits pulses at a pulse emission frequency of less than 150Hz, and the neural stimulation device controls the sensing module to turn on and subsequently sense the induced compound action potential in the manner described above. In the tonic burst emission mode, the control module first emits pulses at a high frequency (the pulse emission frequency is 400Hz to 600Hz, for example, 500Hz, and the corresponding high frequency period T h =2ms), after emitting 4 to 6 pulses, the pulse is emitted at a low frequency (the pulse emission frequency is less than 150Hz, for example, 50Hz, and the corresponding low frequency period T l =20ms) to release pulses, and then release pulses at high frequency, and so on. Figure 4 As shown, when the control module emits pulses at a high frequency, the sensing module is not turned on and the induced compound action potential is not sensed; when the pulses are emitted at a low frequency, while the pulse emission module is instructing to emit pulses at a low frequency, the sensing module is instructing to turn on, similar to the method described above, and the sensing module is instructing to turn on, and after the sensing delay time, the sensing module is instructing to sense the induced compound action potential; after the sensing module is instructing to sense the induced compound action potential, after the ECAP window time has passed, the sensing module is instructing to turn off.

[0042] Another aspect of the present invention provides a neural stimulation system, such as Figure 5 As shown, it includes the above-mentioned neural stimulation device 501 and an electrode wire 502 electrically connected to the neural stimulation device. The electrode wire includes a plurality of stimulation electrodes and sensing electrodes, the stimulation electrode is used to transmit the electrical stimulation signal into the user's body, and the sensing electrode is used to transmit the induced compound action potential caused by the stimulation pulse to the sensing module, wherein the stimulation electrode can be a ring electrode or a directional electrode, etc. This embodiment does not impose any special restrictions on the type of electrode. For example, the electrode wire is an electrode wire with a ring electrode at the distal end. For another example, the electrode wire is an electrode wire with a directional electrode at the distal end. For another example, the electrode wire is an electrode wire with a ring electrode and a directional electrode at the distal end.

[0043] Another aspect of an embodiment of the present invention provides a method for controlling a nerve stimulation device, comprising:

[0044] Instruct the sensing module to be turned on while instructing the pulse to be issued;

[0045] After the pulse is issued, the sensing delay time is passed, and the sensing is instructed to induce a compound action potential; wherein the sensing delay time is the maximum value between the total duration of the pulse and the preset module conversion time;

[0046] The sensing module is instructed to shut down after a preset ECAP window time has passed after the sensing module senses the evoked compound action potential.

[0047] It is not difficult to find that this embodiment is a method embodiment corresponding to the device embodiment, and this embodiment can be implemented in conjunction with the device embodiment. The relevant technical details mentioned in the device embodiment are still valid in this embodiment, and in order to reduce repetition, they are not repeated here. Accordingly, the relevant technical details mentioned in this embodiment can also be applied in the device embodiment.

[0048] Another aspect of the embodiment of the present invention further provides an electronic device, referring to Figure 6 , including at least one processor 601; and, a memory 602 communicatively connected to the at least one processor 601; wherein the memory 602 stores instructions executable by the at least one processor 601, and the instructions are executed by the at least one processor 601, so that the at least one processor 601 can execute the following method for controlling a neural stimulation device: when instructing to release a pulse, instructing to turn on the sensing module; after the instructing to release the pulse, after a sensing delay time has passed, instructing to sense an induced compound action potential; wherein the sensing delay time is the maximum value between the total duration of the pulse and the preset module conversion time; after the instructing the sensing module to sense the induced compound action potential, after a preset ECAP window time has passed, instructing the sensing module to turn off.

[0049] The memory 602 and the processor 601 are connected in a bus manner, and the bus may include any number of interconnected buses and bridges, and the bus connects various circuits of one or more processors 601 and the memory 602 together. The bus can also connect various other circuits such as peripheral devices, voltage regulators, and power management circuits, which are well known in the art and are therefore not further described herein. The bus interface provides an interface between the bus and the transceiver. The transceiver can be one element or multiple elements, such as multiple receivers and transmitters, providing a unit for communicating with various other devices on a transmission medium. The data processed by the processor 601 is transmitted on a wireless medium via an antenna, and further, the antenna also receives data and transmits the data to the processor 601.

[0050] The processor 601 is responsible for managing the bus and general processing, and can also provide various functions, including timing, peripheral interfaces, voltage regulation, power management and other control functions. The memory 602 can be used to store data used by the processor 601 when performing operations.

[0051] Another aspect of the embodiments of the present invention further provides a computer-readable storage medium storing a computer program. When the computer program is executed by a processor, the following control method of a nerve stimulation device is implemented: when instructing to release a pulse, instructing to turn on the sensing module; after the sensing delay time has passed after the instruction to release the pulse, instructing to sense the induced compound action potential; wherein the sensing delay time is the maximum value between the total duration of the pulse and the preset module conversion time; after the preset ECAP window time has passed after the instruction to sense the induced compound action potential, instructing the sensing module to turn off.

[0052] That is, those skilled in the art can understand that all or part of the steps in the above-mentioned embodiment method can be completed by instructing the relevant hardware through a program, and the program is stored in a storage medium, including several instructions to enable a device (which can be a single-chip microcomputer, chip, etc.) or a processor to execute all or part of the steps of the method described in each embodiment of the present application. The aforementioned storage medium includes: U disk, mobile hard disk, read-only memory (ROM, Read-Only Memory), random access memory (RAM, Random Access Memory), disk or optical disk and other media that can store program codes.

[0053] Those skilled in the art will appreciate that the above embodiments are specific embodiments for implementing the present invention, and that in actual applications, various changes may be made in form and detail without departing from the spirit and scope of the present invention.

Claims

1. A nerve stimulation device, characterized in that: include: A control module, a pulse emission module and a sensing module; The pulse issuing module is used to issue pulses according to the instructions of the control module; The sensing module is used to start sensing of evoked compound action potentials according to the instructions of the control module; The control module is used to instruct the sensing module to turn on while instructing the pulse emission module to emit a pulse; to instruct the sensing module to sense the induced compound action potential after a sensing delay time has passed after the pulse emission module has been instructed to emit a stimulation pulse; and to instruct the sensing module to turn off after an ECAP window time has passed after the sensing module has been instructed to sense the induced compound action potential; wherein the sensing delay time is the maximum value between the total duration of the pulse and a preset module conversion time, the total duration of the pulse includes the pulse duration and the sensing refractory period, the pulse duration includes the main pulse time of the pulse, the recovery / charge balance pulse time, and the interval time between the main pulse time and the recovery / charge balance pulse time, and the module conversion time is represented by the duration of module switching in the neural stimulation device.

2. The nerve stimulation device according to claim 1, characterized in that The control module is also used to determine whether it is necessary to sense the induced compound action potential before instructing the sensing module to start up; if sensing is necessary, instructing the sensing module to start up to sense the induced compound action potential.

3. The nerve stimulation device according to claim 1, characterized in that The control module is used to determine whether it is necessary to sense the induced compound action potential, including obtaining the cumulative duration of the pulse emission period of the induced compound action potential that has been sensed in the current cycle period, and if the cumulative duration is less than a preset first duration, it is determined that the induced compound action potential needs to be sensed; wherein the first duration is used to indicate the cumulative duration of the pulse emission period of the induced compound action potential that needs to be sensed in each cycle period, the cycle period includes at least two pulse emission periods, and the first duration is determined based on the vital sign parameters of the user.

4. The nerve stimulation device according to claim 3, characterized in that: The neural stimulation device further comprises: a human posture sensing module; The human body posture sensing module is used to sense the posture of the human body; The control module is also used to communicate with the human posture sensing module to obtain the human posture. If a change in the human posture is detected within the cycle, a new cycle is started and the accumulated duration is reset to zero.

5. The nerve stimulation device according to claim 1, characterized in that: The control module is also used to update the parameters of the pulse according to the sensed evoked compound action potential.

6. The nerve stimulation device according to any one of claims 1 to 5, characterized in that: The nerve stimulation device is applied to spinal cord electrical stimulation, dorsal root ganglion electrical stimulation, sympathetic nerve electrical stimulation, vagus nerve electrical stimulation or deep brain electrical stimulation.

7. The nerve stimulation device according to claim 1, characterized in that: The nerve stimulation device comprises a first timing module, a second timing module and a third timing module, The first timing module is configured as a timing mode, the timing duration is the duration of the pulse emission cycle, and when the first timing module overflows, the control module instructs to turn on the sensing module; The second timing module is configured to be in a timing mode when the control module instructs the sensing module to start, the timing duration is the duration of the sensing delay time, and when the second timing module overflows, the control module instructs the sensing module to sense the evoked compound action potential; The third timing module is configured as a timing mode when the control module instructs the sensing module to sense the evoked compound action potential. The timing duration is the duration of the ECAP window time, and when the third timing module overflows, the control module instructs the sensing module to shut down.

8. The nerve stimulation device according to claim 3, characterized in that: The nerve stimulation device comprises a first timing module, a first counter and a second counter, The first timing module is configured as a timing mode, and the timing duration is the duration of the pulse emission cycle; A first counter, configured to increase the first counter by one when the first timing module overflows; A second counter is configured to add one when the sensing module senses the generation of a pulse emission cycle that induces a compound action potential; When the count of the first counter is less than the number of pulse emission periods in the cycle, and the count of the second counter is less than the number of pulse emission periods corresponding to the first duration, the control module instructs the pulse emission module to emit a pulse and at the same time instructs the sensing module to turn on.

9. The nerve stimulation device according to claim 3, characterized in that: The nerve stimulation device comprises a first timing module, a fourth timing module and a fifth timing module, The first timing module is configured as a timing mode, and the timing duration is the duration of the pulse emission cycle; The fourth timing module is configured as a timing mode, the timing duration is a blank sensing duration, and the blank sensing duration is a cumulative duration of the pulse emission cycle in which no compound action potential is induced during the pulse emission cycle; The fifth timing module is configured as a timing mode, and the timing duration is the first duration; Before the fourth timing module overflows, the control module controls the sensing module to be in a closed state; when the fourth timing module overflows, the control module instructs the fifth timing module to start, and when the fifth timing module does not overflow and the first timing module overflows, the control module instructs the pulse emission module to emit pulses while instructing the sensing module to start.

10. The nerve stimulation device according to claim 1, characterized in that: The pulse emission mode of the neural stimulation device is an excitation peak emission mode, or the pulse emission mode of the neural stimulation device is an excitation cluster emission mode, and the control module instructs the pulse emission module to emit the pulse at a low frequency and at the same time instructs the sensing module to turn on.

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