A potential signal acquisition method and an implantable nerve stimulator

Abstract

The present disclosure provides a potential signal acquisition method and an implantable nerve stimulator, wherein the method comprises: outputting a pulse stimulation signal to a stimulation target; performing passive charge balance on the stimulation target after the end of the stimulation pulse of the pulse stimulation signal; and acquiring a potential signal of the target stimulation target after the end of the passive charge balance and before the start of the next stimulation pulse.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to the field of medical devices, in particular to a potential signal acquisition method and an implantable nerve stimulator. BACKGROUND

[0002] A deep brain stimulator is an implantable medical device, mainly used for treating movement disorders and mental disorders, and its indications include Parkinson's disease, dystonia, essential tremor and obsessive-compulsive disorder, etc. With the development of neural regulation field, the correlation between the mechanism of deep brain electrical stimulation and the electrical stimulation parameters is becoming closer and closer. As a direct intervention on the electrical activity of deep brain, the relationship between deep brain electrical stimulation and spontaneous brain electrical activity may affect the efficacy and side effects of stimulation. Therefore, the demand for developing a deep brain stimulator with deep brain potential signal acquisition function is more urgent.

[0003] In related technologies, the acquired potential signal is mainly LFP (local field potential) signal and ECAP (evoked compound action potential) signal, with amplitude of uV order of magnitude, and the acquisition occurs during the stimulation pulse, which will produce noise influence on the acquisition of potential signal. SUMMARY

[0004] The present disclosure provides a potential signal acquisition method and an implantable nerve stimulator.

[0005] According to a first aspect of the embodiments of the present disclosure, a potential signal acquisition method is provided, comprising:

[0006] outputting a pulse stimulation signal to a stimulation target point;

[0007] passively balancing charges of the stimulation target point after the end of the stimulation pulse of the pulse stimulation signal;

[0008] acquiring a potential signal of the target stimulation point after the end of the passive charge balancing and before the start of the next stimulation pulse.

[0009] According to a second aspect of the embodiments of the present disclosure, an implantable nerve stimulator is provided, comprising a main controller, a pulse generation module and a signal acquisition module;

[0010] The main controller is configured to control the pulse generation module to output a pulse stimulation signal to a stimulation target point.

[0011] The main controller is configured to control the pulse generation module to output a pulse stimulation signal to a stimulation target point.

[0012] The main controller is configured to control the pulse generation module to output a pulse stimulation signal to a stimulation target point.

[0013] In the embodiments of the present disclosure, after inputting the pulse stimulation signal to the stimulation target, passive charge balance can be performed on the stimulation target after the end of the stimulation pulse, i.e., at the stimulation falling edge of the pulse stimulation signal, and the potential signal of the target target can be collected after the passive charge balance ends and before the next stimulation pulse starts. With this scheme, the potential signal of the target object can be collected in the case of eliminating the residual charge of the pulse stimulation signal, so that the collected potential signal is more accurate.

[0014] It should be understood that the above general description and the following detailed description are only exemplary and explanatory, but not limiting the present disclosure. BRIEF DESCRIPTION OF DRAWINGS

[0015] The accompanying drawings, which are incorporated into the specification and constitute a part of the specification, illustrate embodiments consistent with the present disclosure and, together with the specification, serve to explain the principles of the present disclosure.

[0016] Figure 1 is a potential signal collection method flowchart according to an exemplary embodiment;

[0017] Figure 2 is a stimulation waveform schematic diagram according to an exemplary embodiment;

[0018] Figure 3 is a time length determination method flowchart according to an exemplary embodiment;

[0019] Figure 4 is another stimulation waveform schematic diagram according to an exemplary embodiment;

[0020] Figure 5 is another stimulation waveform schematic diagram according to an exemplary embodiment;

[0021] Figure 6 is another stimulation waveform schematic diagram according to an exemplary embodiment;

[0022] Figure 7 is another stimulation waveform schematic diagram according to an exemplary embodiment;

[0023] Figure 8 is an implantable neurostimulator schematic diagram according to an exemplary embodiment;

[0024] Figure 9 is a structural schematic diagram of a computer device according to an exemplary embodiment. DETAILED DESCRIPTION

[0025] The exemplary embodiments will be described in detail herein with reference to the attached drawings. The description of the exemplary embodiments is only to illustrate the principles of the present disclosure and should not be construed to limit the scope of the present disclosure. Rather, they are merely examples of apparatuses and methods consistent with some aspects of the present disclosure as detailed in the appended claims.

[0026] The terminology used in the present disclosure is for the purpose of describing particular embodiments only and is not intended to be limiting of the present disclosure. As used in the present disclosure and the appended claims, the singular forms "a," "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

[0027] It will be understood that, although the terms first, second, third, etc. can be used herein to describe various information, these terms are not intended to denote a temporal or chronological order. Rather, these terms are used only to distinguish different sets of information from one another. For example, a first information can be termed a second information, and similarly, a second information can also be termed a first information, without departing from the scope of the present disclosure. As used herein, the word "if' can be construed to mean "when" or "in response to determining" depending on the context.

[0028] To make the potential signal acquisition method provided by the present disclosure clearer, the process of the scheme provided by the present disclosure is described in detail below in combination with the drawings and specific embodiments.

[0029] Referring to Figure 1 , Figure 1 is a flowchart of a potential signal acquisition method according to an embodiment of the present disclosure. As Figure 1 shown, the flow includes steps 101 to 103.

[0030] Step 101, output a pulse stimulation signal to a stimulation target.

[0031] The stimulation target is a part of the body of the target object that needs to be stimulated. For example, the stimulation target can be a target region in the brain tissue of the target patient that needs to be stimulated by the deep brain stimulator during the treatment process. The pulse stimulation signal is a stimulation signal output when stimulating the target object. For example, the pulse stimulation signal can be a pulse signal output by the deep brain stimulator when stimulating the target region in the brain tissue of the target patient.

[0032] The step can output a pulse stimulation signal to the stimulation target of the target object to stimulate the stimulation target of the target object. For example, the step can output a corresponding pulse signal to a target region in the brain tissue of the target patient to stimulate the target region in the brain tissue. For example, the signal waveform of the pulse stimulation signal output by the step to the stimulation target can be a waveform as shown in Figure 2 It can be understood that the process of outputting the pulse stimulation signal to the stimulation target is a periodic output process, and in the embodiments of the present disclosure, the collection of the potential signal is also implemented within an output period. For example Figure 2 In the embodiments of the present disclosure, the potential signal is collected within a time t in a pulse stimulation signal output period.

[0033] It can be understood that the embodiments of the present disclosure do not limit the specific implementation of outputting the pulse stimulation signal to the stimulation target. For example, the main controller of the deep brain stimulator can be used to control the pulse generation module, and the pulse stimulation signal can be output to the stimulation target based on the stimulation electrode.

[0034] Step 102, after the stimulation pulse of the pulse stimulation signal ends, passive charge balance is performed on the stimulation target.

[0035] In the step, passive charge balance can be performed on the stimulation target after the stimulation pulse of the pulse stimulation signal ends. The step can use the passive charge balance process to reduce the "residual" effect on the body of the target object after the stimulation pulse ends.

[0036] It can be understood that the specific manner of passive charge balance in the embodiments of the present disclosure is not limited. For example, in the embodiments of the present disclosure Figure 2 For example, the passive charge balance process can start at the moment when the stimulation pulse ends and last for a preset period of time to gradually eliminate the residual charge on the body of the target object after the pulse stimulation signal is output.

[0037] Step 103, after the passive charge balance ends and before the next stimulation pulse starts, the potential signal of the target target is collected.

[0038] Since the passive charge balance process can reduce or eliminate the residual charge caused by the pulse stimulation signal output to the stimulation target, in the embodiments of the present disclosure, it is desirable to collect the potential signal without any residual charge effect or with residual charge below a threshold value, so that the collected potential signal is more accurate and is not or is reduced by the influence of the residual charge of the pulse stimulation signal.

[0039] In this step, the potential signal of the target point is collected within the acquisition time t, after the passive charge balance is completed and before the next stimulation pulse begins, i.e., after the residual charge of the output pulse stimulation signal is eliminated or below the threshold.

[0040] The acquisition duration t can be a pre-set acquisition time length, or it can be a duration information dynamically obtained based on different information such as acquisition requirements, target object's physical parameters, and stimulation parameters of the pulse stimulation signal, and is not limited thereto. In addition, the target point can be a target point region that is the same as or different from the stimulation target point, or it can be a target point region that partially overlaps with the stimulation target point. In the embodiments of this disclosure, the relationship or influence between the stimulation target point and the target point is not limited.

[0041] In this embodiment of the present disclosure, after outputting a pulsed stimulation signal to the target point, passive charge balancing can be performed on the target point after the stimulation pulse ends. Furthermore, after the passive charge balancing is completed and before the next stimulation pulse begins, the potential signal of the target point is acquired. This approach allows for the acquisition of the potential signal of the target object only after the residual charge has been eliminated or is at a low level, resulting in a more accurate acquisition of the potential signal.

[0042] In some optional embodiments, in step 103, after the passive charge balance is completed and before the next stimulation pulse begins, the potential signal of the target point is collected. Specifically, this may include: collecting the potential signal of the target point after a delay period starting from the delay start time.

[0043] by Figure 2 For example, the moment corresponding to the end of the stimulation pulse can be taken as the start time of the delay, and the duration corresponding to T2 can be taken as the delay duration. That is, in the above optional embodiment, the time T2 after the falling edge of the stimulus can be determined as the end of the passive charge balance and the beginning of the next stimulation pulse. That is, at the end of the T2 duration, it is considered that the residual charge of the output pulse stimulation signal has been eliminated or substantially eliminated, thereby acquiring the potential signal of the target point.

[0044] In the above optional embodiments, the delay start time is selected as the time corresponding to the end of the stimulation pulse, that is, the falling edge of the stimulation is taken as the delay start time. In some optional embodiments, the time corresponding to the start of the next stimulation pulse, that is, the time corresponding to the rising edge of the pulse stimulation signal, or the charge balance time can be taken as the delay start time. The difference is that, with different delay start times, the delay duration can be adaptively changed to ensure that at the end of the delay duration, the stimulation signal at the target point is basically zero, that is, the influence of residual charge in the output pulse stimulation signal is eliminated.

[0045] In some optional embodiments, the delay duration and / or the collection duration can be determined according to a stimulation parameter of the pulse stimulation signal; the stimulation parameter comprises at least one of the following: frequency information, amplitude information, pulse width information, contact impedance information of the collection electrode and / or the stimulation electrode. The contact impedance information of the collection electrode and / or the stimulation electrode specifically refers to the loop impedance of a collection and / or stimulation loop formed by the contact of the collection electrode and / or the stimulation electrode and the patient tissue.

[0046] For example, the delay duration or the collection duration can be determined according to one or more of the frequency information, the amplitude information, the pulse width information, and the contact impedance information of the pulse stimulation signal. It can be understood that the stimulation parameter is the parameter information of the pulse stimulation signal, and the above is only a specific example of the parameter, and more stimulation parameters can be selected as the parameter for determining the delay duration or the collection duration in the specific implementation. In a preferred embodiment, the delay duration can be determined according to the amplitude and the pulse width of the pulse stimulation signal. The collection duration can be determined according to the frequency, the pulse width, and the delay duration of the pulse stimulation signal. In deep brain stimulation, the amplitude of the pulse stimulation signal is 0-10V, the pulse width is 30-450us, and the delay duration T2 is preferably in the range of 0-100ms. In deep brain stimulation, the frequency of the pulse stimulation signal is 2-250Hz, and the collection time t is preferably in the range of 10us-100ms.

[0047] In some optional embodiments, the determination of the delay duration and / or the collection duration according to the stimulation parameter of the pulse stimulation signal can comprise steps 301-303. Figure 3 As shown in the figure, the determination of the delay duration and / or the collection duration according to the stimulation parameter of the pulse stimulation signal can comprise steps 301-303.

[0048] Step 301: Obtain the stimulation parameter.

[0049] This step can obtain the stimulation parameter of the pulse stimulation signal, for example, the frequency information, the amplitude information, the pulse width information, and the contact impedance information of the pulse stimulation signal.

[0050] Step 302: Determine the delay duration and / or the collection duration to be set according to the stimulation parameter.

[0051] After obtaining the stimulation parameter, this step can comprehensively determine the delay duration or the collection duration to be set according to the stimulation parameter. It should be noted that the specific algorithm for determining the delay duration or the collection duration to be set according to the stimulation parameter can be obtained by pre-storing a mapping table or by pre-designing a calculation formula or algorithm, and the embodiments of the present disclosure are not limited.

[0052] In one possible implementation, supervised learning, unsupervised learning, or reinforcement learning methods from machine learning can be used to determine the corresponding delay or acquisition duration based on the stimulus parameters. In another possible implementation, after acquiring the stimulus parameters, a lookup table can be used to determine the corresponding delay or acquisition duration. The above are merely illustrative implementations and do not constitute a limitation on the implementation of the solution.

[0053] Step 303: If the proposed delay duration and / or acquisition duration is different from the proposed delay duration and / or acquisition duration, update the delay duration and / or acquisition duration according to the proposed delay duration and / or acquisition duration.

[0054] After determining the proposed delay duration or data collection duration, this step can further determine whether the proposed value differs from the current value. If they are the same, there is no need to update; if they are different, the current value is updated according to the determined proposed value, that is, the delay duration and / or data collection duration are updated according to the proposed delay duration and / or data collection duration.

[0055] In some alternative embodiments, determining the delay duration and / or the acquisition duration based on the stimulation parameters of the pulse stimulation signal includes: determining the delay duration and / or the acquisition duration based on the range of variation of the stimulation parameters of the pulse stimulation signal.

[0056] If the current stimulation parameters cannot be collected in real time, in the above embodiments, the range of variation of the stimulation parameters can be determined first, and the delay duration or collection duration can be determined according to the range of variation of the stimulation parameters of the pulse stimulation signal.

[0057] In some alternative embodiments, the pulsed stimulation signal can be output to the stimulation target based on the stimulation frequency; the potential signal of the target can be acquired based on the sampling frequency; wherein the sampling frequency is an integer multiple of the stimulation frequency, or the stimulation frequency is an integer multiple of the sampling frequency.

[0058] In the above optional embodiments, the stimulation frequency can be set to an integer multiple of the sampling frequency. For example, the stimulation frequency can be set to x * sampling frequency, where x is an integer. When x = 1, such as... Figure 2 As shown; in the case of x = 2, as Figure 4 As shown.

[0059] In the above optional embodiments, the sampling frequency can be set to an integer multiple of the stimulation frequency. For example, the sampling frequency can be set to x * stimulation frequency, where x is an integer. When x = 1, such as... Figure 5 As shown; in the case of x = 2, as Figure 6 As shown.

[0060] In some optional embodiments, the potential signal of the target target point can be collected at least once in the same cycle of outputting the pulse stimulation signal to the stimulation target point. In the embodiments of the present disclosure, the potential signal of the target target point can be collected once or multiple times in the same cycle of outputting the pulse stimulation signal to the stimulation target point. For example, the number of collection times can be set to 3 times per stimulation cycle as required, as shown in the following table. Figure 7

[0061] Figure 8 As shown in the following table, the present disclosure provides an implantable neurostimulator, for example, a deep brain stimulator, which can perform the potential signal collection method of any embodiment of the present disclosure. The deep brain stimulator comprises a main controller, a pulse generation module and a signal collection module; wherein the main controller,

[0062] controls the pulse generation module to output a pulse stimulation signal to a stimulation target point; and controls passive charge balance of the stimulation target point after the end of a stimulation pulse of the pulse stimulation signal.

[0063] controls the signal collection module to collect a potential signal of a target target point after the end of the passive charge balance and before the start of the next stimulation pulse.

[0064] Optionally, the deep brain stimulator further comprises a potential noise elimination module; and the main controller is further configured to

[0065] control the pulse generation module to access the potential noise elimination module after the end of the stimulation pulse of the pulse stimulation signal; and control the pulse generation module to disconnect the potential noise elimination module before the start of the next stimulation pulse.

[0066] Optionally, the deep brain stimulator further comprises a stimulation switch array and a collection switch array; and the pulse generation module is configured to

[0067] send a synchronization signal to the main controller after the falling edge of the stimulation pulse of the pulse stimulation signal, control the stimulation switch array to disconnect the stimulation channel of the pulse generation module by the main controller, and control the stimulation switch array to access the stimulation channel of the pulse generation module by the main controller after the end of the potential signal collection; or

[0068] send a synchronization signal to the main controller before the potential signal collection, control the stimulation switch array to disconnect the stimulation channel of the pulse generation module by the main controller, and control the stimulation switch array to access the stimulation channel of the pulse generation module by the main controller after the end of the potential signal collection; or

[0069] ​The main controller controls the acquisition switch array to disconnect the acquisition channel of the signal acquisition module before the rising edge of the stimulation pulse of the pulse stimulation signal, and controls the acquisition switch array to access the acquisition channel of the signal acquisition module after the end of the stimulation pulse.

[0070] For the deep brain stimulator embodiment, since it basically corresponds to the method embodiment, the relevant parts are described in the method embodiment. The above-described deep brain stimulator embodiment is only illustrative, wherein the units described as separate components can or can not be physically separated, and the components displayed as units can or can not be physical units, i.e., can be located in one place or distributed to multiple network units. Part or all of the modules can be selected according to actual needs to achieve the purpose of at least one embodiment of the present disclosure. Those skilled in the art can understand and implement without creative labor.

[0071] The present disclosure also provides a computer device, including a memory, a processor, and a computer program stored in the memory and executable on the processor, wherein the processor can implement the potential signal acquisition method of any embodiment of the present disclosure when executing the program.

[0072] Figure 9 A more specific computer device hardware structure schematic diagram provided by the embodiment of the present disclosure is shown, which can include a processor 1010, a memory 1020, an input / output interface 1030, a communication interface 1040, and a bus 1050. The processor 1010, the memory 1020, the input / output interface 1030, and the communication interface 1040 are connected to each other through the bus 1050 for communication within the device.

[0073] The processor 1010 can be implemented in the form of a general-purpose CPU (Central Processing Unit, central processor), a microprocessor, an application-specific integrated circuit (ASIC), or one or more integrated circuits, etc., for executing related programs to implement the technical solutions provided by the embodiments of the present disclosure.

[0074] The memory 1020 can be implemented in the form of a ROM (Read Only Memory), a RAM (Random Access Memory), a static storage device, a dynamic storage device, etc. The memory 1020 can store an operating system and other application programs, and when the technical solutions provided by the embodiments of the present specification are implemented by software or firmware, the related program codes are stored in the memory 1020 and are called and executed by the processor 1010.

[0075] The input / output interface 1030 is configured to connect an input / output module to realize information input and output. The input / output module can be configured as a component in the device (not shown in the figure) or can be externally connected to the device to provide corresponding functions. The input device can include a keyboard, a mouse, a touch screen, a microphone, various sensors, etc., and the output device can include a display, a speaker, a vibrator, an indicator light, etc.

[0076] The communication interface 1040 is configured to connect a communication module (not shown in the figure) to realize the communication interaction between the device and other devices. The communication module can realize communication through a wired manner (such as USB, network cable, etc.) or through a wireless manner (such as mobile network, WIFI, Bluetooth, etc.).

[0077] The bus 1050 includes a channel to transmit information between various components (such as the processor 1010, the memory 1020, the input / output interface 1030, and the communication interface 1040) of the device.

[0078] It should be noted that although the above device only shows the processor 1010, the memory 1020, the input / output interface 1030, the communication interface 1040, and the bus 1050, in the specific implementation process, the device can also include other components necessary for normal operation. In addition, those skilled in the art can understand that the above device can also only include the components necessary to implement the solutions of the embodiments of the present specification, and does not have to include all the components shown in the figure.

[0079] The present disclosure also provides a computer readable storage medium having a computer program stored thereon, wherein the program is executed by a processor to implement the potential signal acquisition method of any one of the embodiments of the present disclosure.

[0080] The non-transitory computer readable storage medium can be a ROM, a random access memory (RAM), a CD-ROM, a magnetic tape, a floppy disk, and an optical data storage device, and the present disclosure is not limited thereto.

[0081] In some optional embodiments, the embodiments of the present disclosure provide a computer program product comprising computer readable code which, when run on a device, causes a processor in the device to perform a potential signal acquisition method as provided by any of the above embodiments. The computer program product can be implemented in particular by means of hardware, software or a combination thereof.

[0082] Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the application disclosed herein. The present disclosure is intended to cover any variations, uses or adaptations of the present disclosure following, in general, the principles of the present disclosure and including such

[0083] It will be understood that the present disclosure is not limited to the precise structures herein described and illustrated in the drawings, and that various modifications and changes can be made without departing from its scope. The scope of the present disclosure is limited only by the claims that follow.

[0084] The above description is intended to be illustrative and not restrictive. Many other modifications within the scope of the present disclosure will be readily apparent to those skilled in the art, and the scope of the present disclosure should in no way be limited only to the described embodiments but can be implemented on the basis of any equivalents.

Claims

1. An implantable neurostimulator, comprising: The implantable nerve stimulator comprises a main controller, a pulse generation module and a signal acquisition module, wherein the main controller, is configured to control the pulse generation module to output a pulse stimulation signal to a stimulation target point, and perform passive charge balance on the stimulation target point after the stimulation pulse of the pulse stimulation signal ends; is configured to control the signal acquisition module to acquire a potential signal of a target point after the passive charge balance ends and before a next stimulation pulse starts; the main controller controls the signal acquisition module to acquire the potential signal of the target point after the passive charge balance ends and before the next stimulation pulse starts, including: controlling the signal acquisition module to acquire the potential signal of the target point after a delay time length from a delay start time point; the main controller is further configured to: determine the delay time length and / or the acquisition time length according to stimulation parameters of the pulse stimulation signal; the stimulation parameters include at least one of the following: frequency information, amplitude information, pulse width information, contact impedance information of an acquisition electrode and / or a stimulation electrode; wherein the main controller determines the delay time length and / or the acquisition time length according to the stimulation parameters of the pulse stimulation signal, including: obtaining the stimulation parameters; determining a set delay time length and / or acquisition time length according to the stimulation parameters; updating the delay time length and / or the acquisition time length according to the set delay time length and / or acquisition time length when the set delay time length and / or acquisition time length is different from the delay time length and / or the acquisition time length; determining the delay time length and / or the acquisition time length according to a change range of the stimulation parameters of the pulse stimulation signal in response to being unable to obtain the stimulation parameters in real time; the main controller is further configured to: acquire the potential signal of the target point at least once in the same cycle of outputting the pulse stimulation signal to the stimulation target point.

2. The implantable neurostimulator of claim 1, wherein, The implantable nerve stimulator further comprises a potential noise elimination module; and the main controller is further configured to: control the pulse generation module to access the potential noise elimination module after the stimulation pulse of the pulse stimulation signal ends, and control the pulse generation module to disconnect the potential noise elimination module before a next stimulation pulse starts.

3. The implantable neurostimulator of claim 1, wherein, The delay start time point includes a stimulation rising edge time point of the pulse stimulation signal, a stimulation falling edge time point of the pulse stimulation signal or a charge balance time point.

4. The implantable neurostimulator of claim 1, wherein, The main controller is further configured to: output the pulse stimulation signal to the stimulation target point based on a stimulation frequency; acquire the potential signal of the target point based on a sampling frequency; wherein the sampling frequency is an integer multiple of the stimulation frequency, or the stimulation frequency is an integer multiple of the sampling frequency.

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