Method for switching stimulation scheme and related product

Abstract

Provided are a method for switching a stimulation scheme and a related product. The method comprises: in a sensing phase, determining, on the basis of an acquired bioelectric signal, a plurality of energy features of the bioelectric signal, wherein the energy features comprise an energy value or an energy proportion; comparing the plurality of energy features with one or more energy thresholds, wherein the one or more energy thresholds are used for defining a plurality of energy intervals; and determining, on the basis of energy intervals to which the plurality of energy features belong, whether to switch the stimulation scheme. The method can effectively avoid misjudgments caused by transient signal changes, so that the switching of the stimulation scheme is more accurate.

Description

Method for switching stimulation programs and related products Cross-reference to related applications

[0001] The present application claims priority from the Chinese patent application No. 202411049155.4, filed on July 31, 2024, and entitled “Method for switching stimulation programs and related products”. TECHNICAL FIELD

[0002] The present disclosure relates generally to the technical field of data processing. More specifically, the present disclosure relates to a method for switching stimulation programs, a neural stimulator, a device, and a computer readable storage medium. BACKGROUND

[0003] When treating functional disorder diseases such as Parkinson's disease, a conventional deep brain stimulation system (DBS) often adopts an open-loop electrical stimulation treatment method. The open-loop electrical stimulation treatment method is a fixed continuous stimulation output method, which cannot accurately regulate in real time according to the clinical symptoms or disease changes of the patient. Doctors often adjust the stimulation treatment parameters for patients according to the clinical symptoms of the patients combined with clinical experience, so when the clinical symptoms or disease changes of the patient, the patient still needs to be hospitalized for parameter regulation by the clinician.

[0004] In order to solve the above problems, a stimulation system capable of closed-loop regulation of the stimulation program has become a research hotspot today. The closed-loop stimulation system can monitor brain electrical data, and when an abnormal signal is detected, the corresponding stimulation is automatically output. However, since the transient abnormal signal may not be caused by the onset of the disease, it may also be caused by the user's movement or action, so there is a risk of misjudgment when the current technology switches the stimulation program as soon as an abnormal signal is detected.

[0005] Therefore, there is an urgent need to provide a technical solution for switching the stimulation program in order to improve the accuracy of switching the stimulation program and reduce the risk of misjudgment. SUMMARY

[0006] In order to at least solve one or more of the above-mentioned technical problems, the present disclosure proposes, in various aspects, a method for switching stimulation programs, a neural stimulator, a device, and a computer readable storage medium.

[0007] In a first aspect, the present disclosure provides a method for switching stimulation protocols, comprising: in a sensing phase, determining a plurality of energy features of a bioelectric signal based on the acquired bioelectric signal, wherein the energy features comprise energy values or energy proportions; comparing the plurality of energy features with one or more energy thresholds, wherein the one or more energy thresholds are used to divide a plurality of energy intervals; and determining whether to switch stimulation protocols based on the energy intervals to which the plurality of energy features belong.

[0008] In some embodiments, determining the plurality of energy features of the bioelectric signal comprises: calculating the bioelectric signal acquired in time series in a sliding window manner to obtain the plurality of energy features, wherein the moving step length of the sliding window is (1-n)×T, n represents the coverage rate, 0≤n<1, and T represents the time length of the amount of data required for a single calculation of energy features.

[0009] In other embodiments, the method further comprises: determining the sensing duration of the sensing phase according to an integer multiple of (1-n)×T; and / or removing artifact signals of an artifact phase before entering the sensing phase; and / or in response to determining the stimulation protocol, performing a soft start operation based on the stimulation parameters of the stimulation protocol so as to output a corresponding stimulation signal in a stimulation phase.

[0010] In some embodiments, the sensing duration is 1 second to 60 minutes; and / or the artifact duration of the artifact phase is 0.1 second to 22.5 seconds; and / or the soft start duration of the soft start operation is 1 second to 8 seconds; and / or the stimulation duration of the stimulation phase is 0.1 second to 24 hours.

[0011] In yet other embodiments, determining whether to switch stimulation protocols comprises: in response to the stimulation protocol determined based on the energy intervals to which the plurality of energy features belong being the same as the current stimulation protocol, entering a stimulation phase and outputting a corresponding stimulation signal based on the current stimulation protocol; or in response to the stimulation protocol determined based on the energy intervals to which the plurality of energy features belong being different from the current stimulation protocol, entering a stimulation phase and outputting a corresponding stimulation signal based on the stimulation protocol determined based on the energy intervals to which the plurality of energy features belong.

[0012] In other embodiments, the method further comprises: adaptively performing one of the following determination modes according to the acquired life activity state and / or the type of the target event: determining whether to switch stimulation protocols based on the stimulation protocol corresponding to the energy interval to which the average value of the plurality of energy features belongs; or determining whether to switch stimulation protocols based on whether a plurality of consecutive energy features are all higher or lower than a certain energy threshold.

[0013] In some embodiments, the method further comprises: calculating an average value of a plurality of energy features determined within an induction duration of the induction phase; comparing the average value with the one or more energy thresholds to determine an energy interval to which the average value belongs; and determining whether to switch the stimulation scheme based on a stimulation scheme corresponding to the energy interval to which the average value belongs.

[0014] In some embodiments, the method further comprises: performing a plurality of rounds of average value calculation to obtain the average value in the induction phase, wherein, in response to determining a first energy feature and a second energy feature, an initial average value of the first energy feature and the second energy feature is calculated, and the initial average value is taken as input data for the next round of average value calculation to be calculated with a next energy feature until average values of all energy features within the induction duration are obtained.

[0015] In some other embodiments, determining whether to switch the stimulation scheme based on the energy interval to which the plurality of energy features belongs comprises: in response to a plurality of consecutive energy features being all higher or lower than a certain energy threshold, determining whether to switch the stimulation scheme based on a stimulation scheme corresponding to an energy interval higher or lower than the certain energy threshold.

[0016] In yet some other embodiments, the method further comprises: in response to a plurality of consecutive energy features being all distributed in a same energy interval, determining whether to switch the stimulation scheme based on a stimulation scheme corresponding to the same energy interval; and in response to a plurality of consecutive energy features being distributed in a plurality of energy intervals, determining whether to switch the stimulation scheme based on a stimulation scheme corresponding to an energy interval adjacent to the certain energy threshold among the plurality of energy intervals, and / or based on a stimulation scheme corresponding to an energy interval adjacent to the current stimulation scheme among the plurality of energy intervals.

[0017] In some embodiments, the method further comprises: determining a feature marker duration of the target event according to a duration of an abnormal signal occurring when the target event occurs in a historical bioelectric signal; and determining a required number of consecutive energy features according to a ratio between the feature marker duration and a moving step of a sliding window in calculating the energy features in a sliding window manner.

[0018] In some other embodiments, the feature marker duration is 0.1s-5min.

[0019] In some embodiments, the method further comprises: in response to there being no plurality of consecutive energy features higher or lower than a certain energy threshold within an induction duration of the induction phase, entering the stimulation phase and outputting a corresponding stimulation signal based on the current stimulation scheme.

[0020] In some embodiments, the span of the frequency band of interest is 5-10 Hz.

[0021] In some embodiments, the span of the frequency band of interest is 5-10 Hz.

[0022] In some embodiments, the span of the frequency band of interest is 5 Hz.

[0023] In some embodiments, the span of the frequency band of interest is 5 Hz.

[0024] In some embodiments, the bioelectric signal comprises a local field potential signal.

[0025] In a second aspect, the present disclosure provides a neural stimulator comprising a stimulation module configured to perform the method according to any one of the first aspect of the present disclosure.

[0026] In a third aspect, the present disclosure provides a device for switching stimulation scheme, comprising: a processor configured to execute program instructions; and a memory storing the program instructions, which, when loaded and executed by the processor, cause the processor to perform the method according to any one of the first aspect of the present disclosure.

[0027] In a fourth aspect, the present disclosure provides a computer-readable storage medium, characterized in that computer-readable instructions are stored thereon, which, when executed by one or more processors, implement the method according to any one of the first aspect of the present disclosure.

[0028] By the method, neural stimulator, device and computer-readable storage medium for switching stimulation scheme as provided above, the embodiments of the present disclosure can effectively avoid misjudgment caused by transient signal changes by setting the induction phase and determining whether to switch the stimulation scheme based on the plurality of energy features of the induction phase, so that the switching of the stimulation scheme is more accurate. BRIEF DESCRIPTION OF DRAWINGS

[0029] The above and other objects, features and advantages of the present disclosure exemplary embodiments will become more apparent from the following detailed description read in conjunction with the accompanying drawings. In the drawings, several embodiments of the present disclosure are illustrated by way of example and not limitation in which like reference numerals represent similar, equivalent or corresponding elements, features and aspects. In the drawings:

[0030] FIG. 1 shows an exemplary method flow chart for switching stimulation scheme according to some embodiments of the present disclosure;

[0031] FIG. 2 shows a schematic diagram of a frequency band of interest according to some embodiments of the present disclosure;

[0032] FIG. 3 shows a schematic diagram of switching stimulation scheme according to some embodiments of the present disclosure;

[0033] FIG. 4 shows a schematic diagram of switching stimulation scheme including a dummy phase and a soft start phase according to an embodiment of the present disclosure;

[0034] FIG. 5a shows a spectrogram of a bioelectrical signal including a artifact signal;

[0035] FIG. 5b shows a spectrogram of a bioelectrical signal after removing the artifact signal;

[0036] FIG. 6 shows an exemplary method flow chart for determining whether to switch stimulation scheme based on average values of a plurality of energy features according to an embodiment of the present disclosure;

[0037] FIG. 7 shows an exemplary method flow chart for determining whether to switch stimulation scheme based on a plurality of consecutive energy features according to an embodiment of the present disclosure;

[0038] FIG. 8a shows a schematic diagram of a plurality of consecutive energy features being distributed in a same energy interval according to an embodiment of the present disclosure;

[0039] FIG. 8b shows a schematic diagram of a plurality of consecutive energy features being distributed in a plurality of energy intervals according to an embodiment of the present disclosure;

[0040] FIG. 9 shows a schematic block diagram of a neural stimulator according to some embodiments of the present disclosure;

[0041] FIG. 10 shows a schematic block diagram of a device for switching stimulation scheme according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0042] The technical solutions in the embodiments of the present disclosure will be apparently and completely described below with reference to the drawings in the embodiments of the present disclosure. Obviously, the described embodiments are part of the embodiments of the present disclosure, rather than all the embodiments. Based on the embodiments in the present disclosure, all other embodiments obtained by a person skilled in the art without creative labor fall within the scope of protection of the present disclosure.

[0043] It should be understood that the terms "comprises" and "comprising" used in the specification and claims of the disclosure, indicate the presence of the stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0044] It should also be understood that the terminology used herein in the specification and claims of the disclosure is for the purpose of describing specific embodiments only and is not intended to be limiting of the disclosure. As used in the specification and the 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 be further understood that the terms "and / or," as used herein in the specification and / or claims, refers to and encompasses any and all possible combinations of one or more of the associated listed items, and that the term "at least one of" followed by a list of two or more items means any single one of the items in the list individually, as well as any combination of two or more of the items in the list.

[0045] As used in the specification and claims, the term "if can be construed to mean "when" or "upon" or "in response to determining" or "in response to detecting" depending on the context. Similarly, the phrase "if it is determined" or "if [a described condition or event] is detected" can be construed to mean "upon determining" or "in response to determining" or "upon detecting [the described condition or event]" or "in response to detecting [the described condition or event]" depending on the context.

[0046] A detailed description of specific embodiments of the disclosure follows.

[0047] FIG. 1 illustrates an exemplary method flowchart for switching stimulation protocols according to some embodiments of the disclosure. As shown in FIG. 1, the method 100 can include, in step S102, during a sensing phase, determining a plurality of energy features of a bioelectric signal based on the acquired bioelectric signal, where the energy features can include an energy value or an energy proportion. The bioelectric signal is a physiological electrical signal emitted by a living body. In some embodiments, the bioelectric signal can include at least one of an electroencephalogram signal, an electrocardiogram signal, an electromyogram signal, etc. In some embodiments, the bioelectric signal can include a local field potential signal. A local field potential (LFP) signal is a transient electrical signal in neural tissue or other tissue, resulting from the superposition and synchronization of cellular electrical activity.

[0048] In some embodiments, the plurality of energy features can be determined based on the full frequency band of the bioelectric signal. In other embodiments, the plurality of energy features can be determined based on a frequency band of interest in the bioelectric signal. In some embodiments, for a received bioelectric signal, filtering, denoising, or the like can be performed to process the bioelectric signal into a plurality of frequency bands, and the frequency band of interest can be one or more of the plurality of frequency bands. In other embodiments, the plurality of frequency bands can include, for example, a Delta band (0-3 Hz), a Theta band (4-7 Hz), an Alpha band (8-12 Hz), a Beta band (13-35 Hz), a Gamma band (36-200 Hz), or the like. The frequency band segmentation of the bioelectric signal can not be limited to this, and more or less can be divided as needed. In yet other embodiments, the frequency band of interest can be set as needed, for example, the frequency band of interest can be a frequency band related to a desired treatment disease.

[0049] The frequency band of interest can be determined according to historical bioelectric signals, so that in step S102, the energy features can be calculated based on the determined frequency band of interest. In some embodiments, the frequency band of interest can be 0-100 Hz or a part thereof. In other embodiments, the span of the frequency band of interest can be 3-22 Hz, for example, 3 Hz, 5 Hz, 7 Hz, 10 Hz, 12 Hz, 15 Hz, 18 Hz, 20 Hz, 21 Hz, or 22 Hz, or the like. The span of the frequency band of interest described herein refers to the distance between the two frequency endpoints of the frequency band of interest. In other embodiments, the span of the frequency band of interest can be determined to be less than the span of the characteristic frequency band, for example, less than the 22 Hz span of the Beta band. In yet other embodiments, the span of the frequency band of interest can be 5-10 Hz. Taking the span of 5 Hz as an example, the span can cover the range of the center frequency (or peak frequency) of the frequency spectrum graph of the bioelectric signal. That is, in the frequency spectrum graph of the bioelectric signal, taking the center frequency (or peak frequency) with the strongest signal intensity as the reference, the frequency range with a span of 5 Hz is selected by extending 2.5 Hz upward and downward. For ease of understanding, the determination method of the frequency band of interest is exemplarily illustrated below taking FIG. 2 as an example.

[0050] As shown in FIG. 2, the horizontal coordinate of the line graph represents the LFP frequency, which can be divided into multiple frequency bands according to the size of the frequency, such as the Delta band (frequency of 0-3 Hz), the Theta band (frequency of 4-7 Hz), the Alpha band (frequency of 8-12 Hz), the Beta band (frequency of 13-35 Hz) and the Gamma band (frequency of 36-200 Hz) in the figure. The vertical coordinate of the line graph represents the energy value determined based on the LFP signal. As further shown in FIG. 2, the line 201 is formed by connecting the energy values of each frequency band of the local field potential signal detected in the state of not taking medicine and the neurostimulator not being in the treatment state, and the line 202 is formed by connecting the energy values of each frequency band of the local field potential signal detected in the state of taking medicine and the neurostimulator not being in the treatment state. From the line graph, the change between the energy values in each frequency band under different states can be seen.

[0051] In some embodiments, the distance between the lines in each frequency band under different states can be compared, that is, the frequency band with a larger energy value difference can be determined as the frequency band of interest. Taking FIG. 2 as an example, by comparing the difference between the line 201 and the line 202 in each frequency band, it can be seen that in the Beta band (frequency of 13-35 Hz), the change between the line 201 and the line 202 is the largest, that is, the change between the energy values under multiple states represented by the line 201 and the line 202 is the largest, and the energy value peak (i.e., the center frequency) appears at 203 of the line 201, which has a frequency of 21.65 Hz and an energy value of 1.24 μVp. Based on this, it is indicated that the Beta band has a higher correlation with the patient's condition, and therefore the Beta band can be determined as the frequency band of interest.

[0052] In other embodiments, the center frequency 203 can be taken as a reference to select a frequency range (such as a 5Hz span range of 19-24Hz in the figure) including the center frequency as the frequency band of interest. Compared with taking the entire Beta band as the frequency band of interest, taking the 5Hz span range including the center frequency as the frequency band of interest (which is smaller than the range of the Beta band), the change of the obtained energy feature is more obvious and accurate, which is beneficial to improve the accuracy of judging whether to switch the stimulation scheme.

[0053] Returning to FIG. 1, the energy value can be obtained by a frequency spectrum, which represents the relationship between signal frequency and energy. The energy value can also be obtained by a time-frequency, which represents the relationship between time and signal frequency. In some embodiments, the energy value can be determined by using classical algorithms such as a direct method (e.g., a periodogram method), an indirect method (e.g., an autocorrelation function method), or an improved direct method (e.g., a Bartlett method, a Welch method, and a Nuttall method). In other embodiments, the energy value can be determined by using algorithms such as a power spectrum calculation based on parametric modeling or a power spectrum calculation based on non-parametric modeling. The power spectrum calculation based on parametric modeling can include an AR model, an MA model, an ARMA model, or the like. The power spectrum calculation based on non-parametric modeling can include a power spectrum estimation based on a MUSIC algorithm or a power spectrum estimation based on an eigenvector, or the like. In yet other embodiments, the energy value can be determined by performing a fast Fourier transform on a time-series signal of a frequency band of interest. The energy ratio is a percentage of an energy value of a specified frequency band relative to an energy value of a full frequency band. In some embodiments, the specified frequency band can be the frequency band of interest described above. In other embodiments, the full frequency band can be a frequency range of 1 Hz to 100 Hz.

[0054] In yet other embodiments, determining the plurality of energy features of the bioelectrical signal can include calculating the bioelectrical signal in a sliding window manner to obtain the plurality of energy features. According to such an arrangement, the plurality of energy features can be obtained in a time series as the bioelectrical signal is collected. In some embodiments, a moving step of the sliding window can be determined according to an amount of data required for a single calculation of an energy feature. For example, assuming that at least 256 sampling points of data are required for a single calculation of an energy feature, and that the 256 sampling points of data are generated for a duration of 1 second (s), the sliding window can be moved by a distance of 1 s each time, and an energy feature of the bioelectrical signal for the previous 1 s can be calculated at the current point. In this case, the energy feature calculated each time is for bioelectrical signals of different time periods, and there is no overlapping data between bioelectrical signals used for adjacent energy feature calculations.

[0055] In some embodiments, the moving step of the sliding window can be (1-n) x T, n represents the coverage rate, 0≤n<1, and T represents the time length of the amount of data required for a single calculation of the energy feature. In some embodiments, 0<n<1. In yet some embodiments, 0≤n≤90%. n can take values such as 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 85%, 90%, or 95%, etc. In some embodiments, T can be, for example, 1s, 2s, 3s, 4s, or 5s, etc. T can take different values according to the algorithm used to calculate the energy feature. In some other embodiments, T is 1s.

[0056] The coverage rate refers to the coincidence rate of the overlapping part between the bioelectric signals used for adjacent two calculations of the energy feature. For example, assuming that the coverage rate is set to 90%, and still taking the example that a single calculation of the energy feature requires 1s of data, the first calculation of the energy feature uses the bioelectric signals from 0s to 1s, and the second calculation of the energy feature uses the bioelectric signals from 0.1s to 1.1s. That is to say, in this example, the moving step of the sliding window is (1-90%) = 0.1s, and each calculation of the energy feature uses the bioelectric signal data of the previous 1s. According to such a setting, especially when the coverage rate is greater than 0, the time accuracy of the calculation of the energy feature is more accurate, and the sensing of abnormal signals in the bioelectric signals is more sensitive. In addition, through the setting of the coverage rate, especially when the coverage rate is greater than 0, the amount of new data required for each calculation can be reduced, thereby reducing the consumption of computing resources.

[0057] After determining the plurality of energy features, step S104 can be performed as further shown in FIG. 1. In step S104, the plurality of energy features can be compared with one or more energy thresholds, wherein the one or more energy thresholds are used to divide a plurality of energy intervals. In some embodiments, one energy threshold can be set, which can divide two energy intervals, i.e., two energy intervals greater than and less than the energy threshold. In some other embodiments, a plurality of energy thresholds can be set, for example, m energy thresholds, m is an integer greater than 1, which can divide m+1 energy intervals.

[0058] In some embodiments, the energy threshold can be determined according to historical bioelectric signals. The historical bioelectric signals described herein can include bioelectric signals obtained before the currently collected bioelectric signals. For example, the energy threshold can be determined according to energy features in different states in the historical bioelectric signals. These different states can include at least one of, for example, no medication and no therapy of the neurostimulator, no medication and therapy of the neurostimulator, medication and no therapy of the neurostimulator, medication and therapy of the neurostimulator, etc., or energy features in other states can also be obtained as needed to obtain the corresponding energy threshold.

[0059] In other embodiments, the energy threshold can be obtained by a stimulation regulation test. For example, a larger stimulation current is output to the patient to obtain a smaller energy threshold; a smaller stimulation current is output to obtain a larger energy threshold. Based on such a manner, multiple energy thresholds can be obtained. In yet other embodiments, in the stimulation regulation test, the energy threshold can be determined based on the average or maximum value of the energy features in the frequency band of interest.

[0060] Further, in step S106, it can be determined whether to switch the stimulation scheme based on the energy interval to which the multiple energy features belong. The multiple energy intervals can correspond to different stimulation schemes respectively, so that after determining the energy interval to which the multiple energy features belong, it can be determined whether to switch the stimulation scheme according to the stimulation scheme corresponding to the energy interval. In some embodiments, the stimulation scheme can include a setting scheme of at least one stimulation parameter such as amplitude, frequency and pulse width of the stimulation wave.

[0061] In yet other embodiments, determining whether to switch the stimulation scheme can include: in response to the stimulation scheme determined based on the energy interval to which the multiple energy features belong being the same as the current stimulation scheme, entering the stimulation phase and outputting a corresponding stimulation signal based on the current stimulation scheme; or in response to the stimulation scheme determined based on the energy interval to which the multiple energy features belong being different from the current stimulation scheme, entering the stimulation phase and outputting a corresponding stimulation signal based on the stimulation scheme determined based on the energy interval to which the multiple energy features belong. Outputting the corresponding stimulation signal includes outputting at least one stimulation parameter such as amplitude, frequency and pulse width, or a stimulation wave formed by the stimulation parameter. In some embodiments, the current stimulation scheme can be the stimulation scheme being executed before entering the current sensing phase, or can be a preset stimulation scheme when not entering the stimulation phase. For example, when the system startup phase has not performed the stimulation operation, the preset stimulation scheme can be set as the default current stimulation scheme.

[0062] In some embodiments, the method 100 can further comprise: according to the acquired life activity state and / or the type of the target event, adaptively executing one of the following determination manners: determining whether to switch the stimulation scheme based on the stimulation scheme corresponding to the energy interval to which the average value of the plurality of energy features belongs; or determining whether to switch the stimulation scheme based on whether the plurality of continuous energy features are all higher or lower than a certain energy threshold. In this embodiment, the life activity state can include, for example, a sleep state, a motion state, an eating state, a medication state, etc. The acquisition of the life activity state can be obtained by detecting physiological parameters (such as heartbeat, blood pressure, breathing rate, etc.) of the living body, or can be obtained by an instruction generated by a user setting or switching, etc. In some embodiments, the target event can include one or more of events related to the disease state or the patient state, such as medication, dyskinesia, tremor, rigidity, dystonia, etc.

[0063] For example, in some scenarios, the user is in a motion state, and the determination manner of determining whether to switch the stimulation scheme based on the plurality of continuous energy features can be adaptively executed, so as to timely and accurately output a suitable stimulation signal in the user's motion process, and avoid misjudgment of stimulation switching caused by instantaneous mutation of bioelectric signals due to excessive user action. In other scenarios, the user is in a sleep state, and since the bioelectric signal in the sleep state is relatively stable, the determination manner of determining whether to switch the stimulation scheme based on the average value can be adaptively executed to achieve more accurate stimulation scheme and more regular stimulation cycle.

[0064] For another example, in yet other scenarios, the user has an event such as dystonia, and the determination manner of determining whether to switch the stimulation scheme based on the plurality of continuous energy features can be adaptively executed, and the energy feature of the feature band (such as the Delta band) related to the target event can be detected and determined, so as to timely switch a suitable stimulation scheme. In some scenarios, the user has tremor in a sleep state, and the determination manner of determining whether to switch the stimulation scheme based on the average value can be adaptively switched to the determination manner of determining whether to switch the stimulation scheme based on the plurality of continuous energy features.

[0065] The specific implementation of determining whether to switch the stimulation scheme based on the average value will be exemplarily described below in combination with FIG. 6; the specific implementation of determining whether to switch the stimulation scheme based on the plurality of continuous energy features will be exemplarily described below in combination with FIGS. 7-8b, which will not be described here. It can be understood that, by triggering the adaptive selection between the determination manner based on the average value and the determination manner based on the plurality of continuous energy features according to the life activity state of the patient and / or the type of the target event, a more suitable stimulation switching determination manner at the moment can be selected, thereby facilitating the output of a more suitable stimulation scheme to adapt to more scenarios.

[0066] The scheme of the embodiments of the present disclosure can be used to implement closed-loop stimulation, and can include a sensing phase and a stimulation phase. In some embodiments, the sensing phase and the stimulation phase can be alternately performed. In the sensing phase, the energy features can be calculated while collecting the bioelectric signals, so as to determine a plurality of energy features of the collected bioelectric signals. In the stimulation phase, the current stimulation scheme can be switched or kept according to the stimulation scheme determined in the sensing phase, so as to output a suitable stimulation signal. For the convenience of understanding, further description will be made in combination with FIG. 3.

[0067] FIG. 3 shows a schematic diagram of switching the stimulation scheme according to some embodiments of the present disclosure. As shown in FIG. 3, the horizontal coordinate in FIG. 3 represents the sensing phase G1 and the stimulation phase G2 arranged in time sequence, the vertical coordinate of the lower graph in FIG. 3 represents the energy features, and the vertical coordinate of the upper graph represents the stimulation amplitude. In the sensing phase, a plurality of energy features can be determined based on the collected bioelectric signals, so as to obtain an energy curve 301; in the stimulation phase, the corresponding stimulation signal is output based on the stimulation scheme determined in the sensing phase before it.

[0068] As further shown in FIG. 3, a, b, c represent different energy thresholds, and a < b < c, the energy range lower than a can correspond to the stimulation scheme A; the energy range from a to b can correspond to the stimulation scheme B; the energy range from b to c can correspond to the stimulation scheme C; and the energy range exceeding c can correspond to the stimulation scheme D. Assuming that the stimulation amplitudes of the stimulation schemes A, B, C, D gradually increase, corresponding to the four stimulation amplitudes sequentially increasing in the diagram. As can be seen from FIG. 3, in response to the energy curve 301 of the sensing phase G1 being located in the energy range greater than the energy threshold b, and at least part of the energy features being located in the energy range greater than the energy threshold c, the stimulation scheme D (or the stimulation scheme C) in the diagram can be executed in the next stimulation phase; in response to the energy curve 301 of the sensing phase G1 being located in the energy range less than the energy threshold c, and no longer corresponding to the stimulation scheme D, the stimulation scheme can be switched to the stimulation scheme C in the next stimulation phase; similarly, in response to the energy curve 301 of the sensing phase G1 being located in the energy range from a to b, and no longer corresponding to the stimulation scheme C, the stimulation scheme can be switched to the stimulation scheme B in the next stimulation phase.

[0069] The method for switching stimulation scheme according to the embodiments of the present disclosure is exemplarily described above in combination with FIG. 1-3, and it can be understood that the method of the embodiments of the present disclosure makes a judgment on switching stimulation scheme based on multiple energy features, which can avoid the situation of misjudgment and premature stimulation caused by making a judgment based on only one energy feature. It can also be understood that the above description is exemplary and not limiting, for example, the method of the embodiments of the present disclosure can not be limited to being applicable to a closed-loop stimulation mode including only an induction phase and a stimulation phase, but can also include other phases. The following will be exemplarily described in combination with FIG. 4.

[0070] FIG. 4 shows a schematic diagram of a switching stimulation scheme including a pseudo phase and a soft start phase according to the embodiments of the present disclosure. As shown in FIG. 4, one switching cycle can include a pseudo phase, an induction phase, a soft start phase and a stimulation phase, and one switching cycle ends and the next switching cycle begins, and the stimulation scheme in each switching cycle is determined by the operation of the induction phase. The horizontal axis in the figure represents time, the induction duration of the induction phase is represented as t1, and the stimulation duration of the stimulation phase is represented as t2.

[0071] In some embodiments, the pseudo signal of the pseudo phase can be removed before entering the induction phase. The removal of the pseudo signal of the pseudo phase can be achieved by removing the signal of the pseudo duration t3, that is, the signal of the pseudo duration t3 does not participate in the judgment of whether to switch the stimulation scheme. This is because usually when the stimulation is stopped and sampling is started, a signal with relatively large amplitude may be generated at the beginning, which can be caused by hardware switching, so that the biological electrical signal is not included in this signal or the biological electrical signal with interference is included, and thus the calculation of the energy feature can be affected. By removing the signal of the pseudo duration t3, the accuracy of calculating the energy feature in the induction phase can be ensured, and thus the accuracy of judging whether to switch the stimulation scheme can be ensured. In some embodiments, the pseudo duration t3 of the pseudo phase can be 0.1 seconds to 22.5 seconds. For example, it can be 0.1s, 0.5s, 1s, 1.5s, 2s, 2.5s, 3s, 5s, 7.5s, 10s, 12.5s, 15s, 17.5s, 20s, or 22.5s, etc. In some preferred embodiments, the pseudo duration t3 of the pseudo phase can be 1.5 seconds.

[0072] For ease of understanding, the following will be exemplarily described in combination with FIG. 5a and FIG. 5b. FIG. 5a shows a spectrum diagram of a bioelectric signal including an artifact signal. FIG. 5b shows a spectrum diagram of the bioelectric signal after removing the artifact signal. The abscissa of the spectrum diagrams shown in FIG. 5a and FIG. 5b represents time, and the ordinate represents amplitude. As shown in FIG. 5a, in the initial stage, a sharp peak 501 appears, which is much larger than the subsequent signal, and if the energy feature represented by the spectrum diagram is used to determine whether to switch the stimulation scheme, it may cause misjudgment. As shown in FIG. 5b, after removing the artifact signal for 1.5 seconds, the energy feature in the obtained spectrum diagram is in a relatively stable and reasonable range, thereby being able to reflect the change of the energy feature of the real bioelectric signal, and based on this to determine whether to switch the stimulation scheme, obviously has higher accuracy.

[0073] Returning to FIG. 4 below, after removing the artifact signal for the artifact duration t3, the sensing stage can be entered, and the sensing duration t1 can be a preset value. In some embodiments, when the sensing duration t1 is reached, whether a new stimulation scheme is determined or not, the next stage needs to be entered, thereby avoiding long stimulation interruption, and being beneficial to guarantee the safety of patients with diseases (such as Parkinson's disease, etc.) requiring long-term treatment. In some embodiments, when the sensing duration t1 is reached, if a new stimulation scheme is not determined, the stimulation scheme is not switched; and if a new stimulation scheme is determined, the new stimulation scheme is switched to and executed in the next stage. In some application scenarios, the duration of the therapeutic effect after the stimulation is turned off can be determined as the sensing duration t1 in the open-loop test by configuring the stimulation parameters to guarantee the stimulation effect. In other embodiments, the sensing duration t1 of the sensing stage can be determined according to an integer multiple (for example, 10 times, 20 times, 50 times, or 100 times, etc.) of (1-n)×T, wherein n represents the coverage. In some embodiments, the sensing duration t1 can be set to 1 second-60 minutes. In yet other embodiments, the sensing duration t1 can be set to 1 second-59 seconds.

[0074] Further, after the stimulation scheme is determined in the induction phase, a soft start phase can be entered. In the soft start phase, a soft start operation is performed based on the stimulation parameters of the stimulation scheme determined in the induction phase, so as to output a corresponding stimulation signal in the stimulation phase. As further shown in FIG. 4, the length of the soft start operation can be denoted as t4, and the soft start length t4 can be set by multiple equal partitions, so that the amplitude of the stimulation signal gradually increases from zero to the set value in a stepwise manner, instead of being immediately switched from zero to the set value. This gradual increase helps to reduce the discomfort and possible side effects of the patient, while ensuring a smooth transition of the stimulation signal. After the soft start operation is performed so that the stimulation signal reaches the set value, the stimulation phase can be entered, in which the stimulation signal of the same amplitude is output for the stimulation length t2. In some embodiments, the soft start length t4 can be set to 1s-8s, such as 1s, 2s, 4s, or 8s, etc.

[0075] The stimulation length t2 can be set as needed. For example, in some embodiments, the stimulation length t2 can be set to 0.1 seconds-24 hours. In other embodiments, the stimulation length t2 can be set to 1 minute-1 hour. In yet other embodiments, the stimulation length t2 can be set to 1 second-59 seconds. In some embodiments, the stimulation length t2 can be set to 0.1 seconds-0.9 seconds.

[0076] It can be understood that the above description is exemplary and not limiting, for example, the induction phase can not be limited to including the artifact phase shown in FIG. 4, for example, in the scenario where the bioelectric signal is collected and the stimulation is output simultaneously, there can be no need to remove the artifact signal.

[0077] FIG. 6 shows an exemplary method flowchart for determining whether to switch the stimulation scheme based on the average value of the plurality of energy features according to embodiments of the present disclosure. As shown in FIG. 6, the method 600 can include: in step S601, a plurality of energy features of the bioelectric signal can be determined based on the bioelectric signal of the stimulation. Step S601 can be the same as or similar to step S102 described above in conjunction with FIG. 1, which will not be described here again.

[0078] Next, in step S602, the average value of the plurality of energy features determined in the induction length of the induction phase can be calculated. In some embodiments, the average value can be calculated based on all the energy features obtained in the induction length t1. For example, the average value can be calculated based on the following formula:

[0079]

[0080] In formula 1, denotes the average value, E1 denotes the first energy feature, E2 denotes the second energy feature, E jrepresents the jth energy feature, and j represents the number of energy features determined in the sensing stage.

[0081] In some embodiments, step S602 can further include: in the sensing stage, performing multiple rounds of average value calculation to obtain the average value, wherein in response to determining the first energy feature and the second energy feature, an initial average value of the first energy feature and the second energy feature is calculated, and the initial average value is taken as input data for the next round of average value calculation to be calculated with the next energy feature, until the average value of all energy features in the sensing duration is obtained. The first energy feature and the second energy feature refer to the first energy feature and the second energy feature calculated in the sensing stage according to the time sequence of collecting the bioelectric signal.

[0082] By the above-mentioned manner of performing multiple rounds of average value calculation, the average value calculated in the current round can be used to replace the average value calculated in the previous round after each round of average value calculation, so that only one round of average value and the single data amount of the bioelectric signal required for calculating the energy feature in the next round need to be stored, without storing all bioelectric signals in the sensing stage and all energy features and then calculating the average value, thereby facilitating saving of storage space and reduction of resource occupation.

[0083] Then, the flow can proceed to step S603, in which the average value can be compared with one or more energy thresholds to determine the energy interval to which the average value belongs. Since the average value of multiple energy features is only one numerical value, after being compared with the energy threshold, it will generally fall into one energy interval. Then, in step S604, whether to switch the stimulation scheme can be directly determined based on the stimulation scheme corresponding to the energy interval to which the average value belongs. If the stimulation scheme corresponding to the energy interval to which the average value belongs is different from the current stimulation scheme, the newly determined stimulation scheme is switched to; if the stimulation scheme corresponding to the energy interval to which the average value belongs is the same as the current stimulation scheme, the current stimulation scheme can be continued to be executed.

[0084] Further, in yet some embodiments, the method 600 can further include: in response to the existence of multi-channel collected bioelectric signals, determining whether each channel switches the stimulation scheme based on the bioelectric signal collected by each channel. For multi-channel collected bioelectric signals, each channel can execute steps S601-S604 to make independent judgments, and the stimulation signals output by each channel can be the same or different. In some other embodiments, for multi-channel collected bioelectric signals, the sensing duration and the stimulation duration of the multi-channels can be set to be the same, so that the multi-channels can enter the sensing stage and the stimulation stage at the same time, which is particularly suitable for the scenario in which there is only one constant current source inside the stimulator.

[0085] The method of determining whether to switch the stimulation scheme based on the average of the plurality of energy features is exemplarily described above in combination with FIG. 6, and it can be understood that the above description is exemplary but not limited, for example, the determination of whether to switch the stimulation scheme can not be limited to the average, and the determination of whether to switch the stimulation scheme can also be based on the plurality of continuous energy features. The exemplary description will be made in combination with FIG. 7 below.

[0086] FIG. 7 shows an exemplary method flowchart of determining whether to switch the stimulation scheme based on the plurality of continuous energy features according to the embodiments of the present disclosure. As shown in FIG. 7, the method 700 can comprise: in step S701, based on the acquired bioelectric signal, the plurality of energy features of the bioelectric signal can be determined. The step S701 can be the same or similar to the step S102 described above in combination with FIG. 1, and will not be described here again.

[0087] Then, in step S702, the plurality of energy features can be compared with one or more energy thresholds. Each energy feature can be compared with one or more energy thresholds to obtain the distribution of the plurality of energy features in the plurality of energy intervals.

[0088] Further, in step S703, based on the stimulation scheme corresponding to the energy interval to which the plurality of continuous energy features belong, it can be determined whether to switch the stimulation scheme. It can be understood that the step S703 can be a specific form of the step S106 described above in combination with FIG. 1, and therefore the description of the step S106 above in combination with FIG. 1 can also be used in the description of the step S703.

[0089] Specifically, in the present embodiment, in response to the plurality of continuous energy features being all higher or lower than a certain energy threshold (i.e., an energy threshold determined after performing the comparison operation of step S702, which can also be referred to as a comparison threshold in the present disclosure), it can be determined whether to switch the stimulation scheme based on the stimulation scheme corresponding to the energy interval higher or lower than the certain energy threshold. The plurality of continuous energy features refers to the plurality of energy features in time sequence in the induction phase.

[0090] In some embodiments, within the induction duration of the induction phase, in response to the plurality of continuous energy features being all higher or lower than a certain energy threshold, and the stimulation scheme determined based on the plurality of continuous energy features being the same as the current stimulation scheme, the induction can be continued until the induction duration ends and the stimulation phase is entered, and the corresponding stimulation signal is output based on the current stimulation scheme. Since no new stimulation scheme is determined in the induction phase, the switching operation of the stimulation scheme can not be performed.

[0091] In some embodiments, during the induction duration of the induction phase, in response to the consecutive energy features being all higher or lower than a certain energy threshold, and the stimulation scheme determined based on the consecutive energy features being different from the current stimulation scheme, the method 700 can further include: directly switching to the stimulation phase based on the determined new stimulation scheme, and outputting a corresponding stimulation signal based on the determined new stimulation scheme.

[0092] In some embodiments, during the induction duration of the induction phase, in response to the consecutive energy features being all higher or lower than a certain energy threshold, the method 700 can further include: entering the stimulation phase based on the stimulation scheme determined based on the consecutive energy features, without waiting for the end of the induction duration to enter the stimulation phase. According to such a setting, the stimulation signal can be output more timely, which is beneficial to improve the induction speed and effectively avoid the occurrence of delayed stimulation. According to the consecutive energy features for switching judgment, the judgment of switching the stimulation scheme can be more accurate, and the misjudgment and premature stimulation caused by judging based on one energy feature or based on interval energy features can be avoided. In some embodiments, the method 700 can further include: determining a feature marker duration of the target event according to a duration of an abnormal signal occurring when the target event occurs in the historical bioelectric signal; and determining the consecutive number X of consecutive energy features according to a ratio between the feature marker duration and a moving step of the sliding window when calculating the energy features in the sliding window manner. In some embodiments, the target event can include one or more of events related to the disease or the patient state, such as taking medicine, movement disorder, tremor, rigidity, etc. In the historical bioelectric signal, each target event can be marked. By converting the historical bioelectric signal into a time-frequency graph, and determining the duration of the abnormal signal occurring when the target event occurs according to the mark in the time-frequency graph, the duration of the abnormal signal occurring when the target event occurs is determined as the feature marker duration associated with the target event. In some other embodiments, the frequency band of the abnormal signal occurring when the target event occurs in the time-frequency graph can also be determined as the frequency band of interest.

[0093] In some embodiments, the feature marker duration can be 0.1s-5min. In some other embodiments, the feature marker duration can be 1min-5min. In some other embodiments, the feature marker duration can be 1s-59s. In some embodiments, the feature marker duration can be 0.1s-0.9s. It can be understood that the feature marker duration can not be limited to this, and other durations can also be obtained according to different target events, different patient conditions, and different application scenarios.

[0094] In some embodiments, the consecutive number X can be calculated based on the following formula:

[0095]

[0096] In formula 2, t5 represents the feature marking duration, n represents the coverage used for determining the plurality of energy features, i.e., the coverage used for calculating the energy features in a sliding window manner, T represents the duration of the amount of data required for a single calculation of the energy features, and (1-n) x T represents the moving step of the sliding window when calculating the energy features in a sliding window manner.

[0097] In other words, in the present embodiment, in response to the continuous X energy features being all higher or lower than a certain energy threshold, whether to switch the stimulation scheme can be determined based on the energy interval in which the X energy features are higher or lower than the certain energy threshold. According to such a setting, the determination of whether to switch the stimulation scheme is associated with the target event, so that the switched stimulation scheme is more targeted to the disease, and the accuracy of the output stimulation is improved.

[0098] In yet some embodiments, a plurality of feature marking durations of a plurality of target events can be set, and the feature marking duration of the required target event can be switched to as needed to determine the required number of consecutive events. In some other embodiments, the switching determination can also be based on the plurality of numbers of consecutive events determined based on the plurality of feature marking durations of the plurality of target events, and the numbers of consecutive events corresponding to different target events can be set with corresponding weights, so that when determining whether to switch the stimulation scheme, the appropriate stimulation scheme is selected from the different stimulation schemes determined based on the different numbers of consecutive events according to the weights.

[0099] In some embodiments, the method 700 can further include, in response to there being no continuous plurality of energy features higher or lower than a certain energy threshold within the sensing duration of the sensing stage, entering the stimulation stage after the sensing duration ends, and outputting a corresponding stimulation signal based on the current stimulation scheme. If there is no continuous plurality of energy features higher or lower than a certain energy threshold within the sensing duration, the stimulation stage can be directly entered based on the current stimulation scheme. According to such a setting, the situation of delayed stimulation due to long-time sensing can be avoided.

[0100] In yet some embodiments, the method 700 can further include: in response to the multi-channel collected bioelectric signals, determining whether to switch the stimulation scheme based on the bioelectric signals collected by each channel; in response to the multi-channels not simultaneously determining whether to switch the stimulation scheme, while the channel that first determines whether to switch the stimulation scheme enters the stimulation phase, the other channels that do not determine whether to switch the stimulation scheme enter the stimulation phase according to the current stimulation scheme. Since the multi-channels can be independently collected and determined, when for example one of the channels meets the condition that the continuous multiple energy features are higher or lower than a certain energy threshold, the other channels can not yet meet the condition that the continuous multiple energy features are higher or lower than a certain energy threshold. At this time, for the case of a stimulator with only one constant current source inside, the multi-channels can be simultaneously switched into the stimulation phase, and the other channels can perform the stimulation operation according to the current stimulation scheme. In response to the multi-channels simultaneously determining whether to switch the stimulation scheme, the multi-channels can simultaneously enter the stimulation phase.

[0101] In some embodiments, in response to the continuous multiple energy features being distributed in the same energy interval, it is determined whether to switch the stimulation scheme based on the stimulation scheme corresponding to the same energy interval; in response to the continuous multiple energy features being distributed in multiple energy intervals, it is determined whether to switch the stimulation scheme based on the stimulation scheme corresponding to the energy interval adjacent to the certain energy threshold in the multiple energy intervals, and / or based on the stimulation scheme corresponding to the energy interval adjacent to the current stimulation scheme in the multiple energy intervals. For ease of understanding, the following will be exemplarily described in combination with FIGS. 8a and 8b.

[0102] FIG. 8a shows a schematic diagram of the continuous multiple energy features being distributed in the same energy interval according to an embodiment of the present disclosure. As shown in FIG. 8a, the energy thresholds a, b, and c divide four energy intervals, which correspond to the stimulation schemes A, B, C, and D, respectively. One black dot in the diagram represents one energy feature. Assuming that the current stimulation scheme is the stimulation scheme B, and the continuous number needs to meet 7, as shown in the diagram, in response to at least 7 continuous energy features (as shown in the dashed circle in the diagram) being greater than the energy threshold b, and the 7 energy features being distributed in the same energy interval (for example, the energy interval greater than b and less than c in the diagram), it can be determined whether to switch the stimulation scheme according to the stimulation scheme C corresponding to the one energy interval. Since in this embodiment, the stimulation scheme C determined according to the continuous multiple energy features is different from the current stimulation scheme B, it can be determined to switch the current stimulation scheme to the stimulation scheme C, and the induction can be stopped to enter the stimulation phase to output the stimulation signal of the stimulation scheme C.

[0103] Fig. 8b shows a schematic diagram of continuous multiple energy features distributed in multiple energy intervals according to an embodiment of the present disclosure. As shown in Fig. 8b, energy thresholds a, b, c divide four energy intervals, which correspond to stimulation schemes A, B, C, D respectively, and one black dot in the diagram represents one energy feature. Assuming that the current stimulation scheme is stimulation scheme C, and the number of continuity needs to satisfy 5, then as shown in the diagram, in response to at least 5 continuous energy features (as shown in the dotted circle in the diagram) being less than energy threshold b, and the 5 energy features being distributed in two different energy intervals (i.e., the energy interval greater than a and less than b in the diagram, and the energy interval less than or equal to a), whether to switch the stimulation scheme can be determined according to the stimulation scheme B corresponding to the energy interval adjacent to energy threshold b (i.e., the energy interval greater than a and less than b) in the two energy intervals, and / or based on the stimulation scheme B corresponding to the energy interval adjacent to the current stimulation scheme C (i.e., the energy interval greater than a and less than b) in the two energy intervals. Since in this embodiment, the stimulation scheme B determined according to the continuous multiple energy features is different from the current stimulation scheme C, it can be determined to switch the current stimulation scheme to stimulation scheme B, and the induction can be stopped to enter the stimulation phase to output the stimulation signal of stimulation scheme B.

[0104] According to such a setting, when the continuous multiple energy features are distributed in different energy intervals, the stimulation scheme corresponding to the energy interval closest to the comparison threshold and / or the current stimulation scheme can be preferentially switched to, so that neither the switching cannot be performed because the continuous multiple energy features do not fall into one energy interval, nor the change range of the switched stimulation scheme is too large because part of the continuous multiple energy features falls in an energy interval far from the comparison threshold, thereby facilitating stable and safe stimulation output.

[0105] The method for switching stimulation schemes according to the embodiments of the present disclosure is described above in combination with Figs. 1-8b, and it can be understood that, by setting the induction phase and determining whether to switch the stimulation scheme based on multiple energy features in the embodiments of the present disclosure, the switched stimulation scheme can be more accurate, and misjudgment and premature stimulation can be effectively avoided. The present disclosure also provides, in multiple embodiments, implementation manners of determining whether to switch the stimulation scheme based on the average of multiple energy features, or based on continuous multiple energy features, wherein determining whether to switch the stimulation scheme based on the average of multiple energy features can be better applied to long-range stimulation scenarios requiring long stimulation time and short induction time; determining whether to switch the stimulation scheme based on continuous multiple energy features can more sensitively detect obvious changes in energy features, and can achieve more timely stimulation output.

[0106] The present disclosure also provides a nerve stimulator. FIG. 9 shows a schematic block diagram of a nerve stimulator according to some embodiments of the present disclosure. As shown in FIG. 9, the nerve stimulator 900 can include a stimulation module 910, which can be configured to perform the method according to any one of the preceding embodiments described in connection with any one of FIGS. 1-8b. In some embodiments, the stimulation module 910 can be implemented by hardware and / or software, for example, in the form of an integrated circuit. In other embodiments, the stimulation module 910 can include an operation unit, a comparison unit, and a determination unit, wherein the operation unit can be configured to determine the energy feature, the comparison unit can be configured to compare the energy feature with the energy threshold, and the determination unit can be configured to determine whether to switch the stimulation scheme according to the comparison result. The nerve stimulator 900 can be implanted in a patient. In some embodiments, the nerve stimulator 900 can be implanted in the skull of the patient.

[0107] In other embodiments, the nerve stimulator 900 can further include an acquisition module, a communication module, a control module (e.g., an MCU), etc., wherein the acquisition module can be configured to acquire a bioelectric signal, for example, a local field potential signal of a brain region of the patient; the communication module can be configured to establish a communication link with a host computer outside the living body to exchange information, for example, to transmit the acquired local field potential signal to the host computer outside the living body; and the control module can be configured to control the modules in the nerve stimulator 900, and to combine and process data of the modules, etc.

[0108] The present disclosure also provides a device for switching a stimulation scheme, which is exemplarily described below in connection with FIG. 10.

[0109] FIG. 10 shows a schematic block diagram of a device for switching a stimulation scheme according to an embodiment of the present disclosure. As shown in FIG. 10, the device 1000 can include a processor 1010 configured to execute program instructions, and a memory 1020 storing the program instructions, which when loaded and executed by the processor 1010, cause the processor 1010 to perform the method according to any one of the preceding embodiments described in connection with any one of FIGS. 1-8b.

[0110] Further, in the technical solutions of the present disclosure, a computer-readable storage medium is also provided, which stores computer-readable instructions, and the computer-readable instructions, when executed by one or more processors, implement the method according to any one of the preceding embodiments described in connection with any one of FIGS. 1-8b.

[0111] The computer-readable storage medium can be any suitable magnetic or magneto-optical storage medium, such as Resistive Random Access Memory (RRAM), Dynamic Random Access Memory (DRAM), Static Random-Access Memory (SRAM), Enhanced Dynamic Random Access Memory (EDRAM), High-Bandwidth Memory (HBM), Hybrid Memory Cube (HMC), and the like, or any other medium that can be used to store the desired information and that can be accessed by an application, module, or both. Any such computer storage media can be part of the device or accessible or connectable thereto. Any application or module described in this disclosure can be implemented by computer-readable / executable instructions stored or otherwise held by such computer-readable media.

[0112] While several embodiments of the disclosure have been shown and described herein, it is to be understood that all such embodiments are merely illustrative of the principles of the disclosure. Numerous modifications, changes and adaptations will now occur to those skilled in the art without departing from the spirit and scope of the disclosure. It should be understood that each of the embodiments described in this disclosure and comprising the several "means" for performing stated actions are intended to mean "means plus function", in accordance with 35 U.S.C. § 1 12, under 35 U.S.C. § 1 12, paragraph (f). It is intended that the appended claims be construed to include alternative embodiments to the extent permitted by the term "means plus function". The appended claims are intended to cover all such alternatives.

[0113] The collection and acquisition of various data in this application comply with relevant legal regulations and are authorized by the data provider. Any organization or individual that needs to obtain external data shall obtain authorization and ensure data security in accordance with the law, and shall not illegally collect, use, process, transmit, sell, provide, or disclose unauthorized or unprotected data.

Claims

1. A method for switching stimulation protocol, comprising: in a sensing phase, determining a plurality of energy features of a bioelectric signal based on the bioelectric signal acquired, wherein the energy features comprise energy values or energy proportions; comparing the plurality of energy features with one or more energy thresholds, wherein the one or more energy thresholds are used to divide a plurality of energy intervals; and determining whether to switch stimulation protocol based on an energy interval to which the plurality of energy features belong. 2.The method of claim 1, wherein determining the plurality of energy features of the bioelectric signal comprises: calculating the bioelectric signal acquired in time series in a sliding window manner to obtain the plurality of energy features, wherein a moving step of the sliding window is (1-n) ×T, n represents coverage, 0≤n<1, and T represents a time length of a data amount required for a single calculation of energy features. 3.The method of claim 2, further comprising: determining a sensing time length of the sensing phase according to an integer multiple of (1-n) ×T; and / or removing artifact signals of an artifact phase before entering the sensing phase; and / or in response to determining a stimulation protocol, performing a soft start operation based on stimulation parameters of the stimulation protocol so as to output a corresponding stimulation signal in a stimulation phase. 4.The method of claim 3, wherein the sensing time length is 1 second to 60 minutes; and / or an artifact time length of the artifact phase is 0.1 second to 22.5 seconds; and / or a soft start time length of the soft start operation is 1 second to 8 seconds; and / or a stimulation time length of the stimulation phase is 0.1 second to 24 hours. 5.The method of claim 1, wherein determining whether to switch stimulation protocol comprises: in response to a stimulation protocol determined based on an energy interval to which the plurality of energy features belong being the same as a current stimulation protocol, entering a stimulation phase and outputting a corresponding stimulation signal based on the current stimulation protocol; or in response to a stimulation protocol determined based on an energy interval to which the plurality of energy features belong being different from a current stimulation protocol, entering a stimulation phase and outputting a corresponding stimulation signal based on the stimulation protocol determined based on the energy interval to which the plurality of energy features belong. 6.The method of any one of claims 1-5, further comprising: adaptively performing one of the following determination manners according to an acquired life activity state and / or a type of an event of interest: determining whether to switch stimulation protocol based on a stimulation protocol corresponding to an energy interval to which an average value of the plurality of energy features belongs; or determining whether to switch stimulation protocol based on whether a plurality of consecutive energy features are all higher or lower than a certain energy threshold. 7.The method of any one of claims 1-6, further comprising: calculating an average value of the plurality of energy features determined in a sensing time length of the sensing phase; comparing the average value with the one or more energy thresholds to determine an energy interval to which the average value belongs; and determining whether to switch stimulation protocol based on a stimulation protocol corresponding to the energy interval to which the average value belongs. 8.The method of claim 7, further comprising: In the induction phase, multiple rounds of average value calculation are performed to obtain the average values, wherein, in response to determining the first energy feature and the second energy feature, an initial average value of the first energy feature and the second energy feature is calculated, and the initial average value is taken as input data for the next round of average value calculation to be calculated with the next energy feature, until the average values of all energy features within the induction duration are obtained.

9. The method of any one of claims 1-6, wherein determining whether to switch the stimulation scheme based on the energy interval to which the plurality of energy features belong comprises: in response to a plurality of consecutive energy features being all higher or lower than a certain energy threshold, determining whether to switch the stimulation scheme based on the stimulation scheme corresponding to the energy interval higher or lower than the certain energy threshold.

10. The method of claim 9, further comprising: in response to a plurality of consecutive energy features being all distributed in the same energy interval, determining whether to switch the stimulation scheme based on the stimulation scheme corresponding to the same energy interval; in response to a plurality of consecutive energy features being distributed in a plurality of energy intervals, determining whether to switch the stimulation scheme based on the stimulation scheme corresponding to the energy interval adjacent to the certain energy threshold among the plurality of energy intervals, and / or based on the stimulation scheme corresponding to the energy interval adjacent to the current stimulation scheme among the plurality of energy intervals.

11. The method of claim 9 or 10, further comprising: determining a feature marker duration of the target event according to the duration of the abnormal signal of the target event occurring in the historical bioelectric signal; determining the number of consecutive energy features required according to the ratio between the feature marker duration and the moving step of the sliding window when calculating the energy features in the sliding window manner.

12. The method of claim 11, wherein the feature marker duration is 0.1s-5min.

13. The method of claim 9, further comprising: in response to the absence of a plurality of consecutive energy features higher or lower than a certain energy threshold within the induction duration in the induction phase, entering the stimulation phase and outputting the corresponding stimulation signal based on the current stimulation scheme.

14. The method of claim 1, further comprising: determining the plurality of energy features based on a frequency band of interest in the bioelectric signal, wherein the frequency band of interest is 0-100Hz or a part of the frequency band; and / or the span of the frequency band of interest is 3Hz-22Hz.

15. The method of claim 14, wherein the span of the frequency band of interest is 5Hz-10Hz; preferably, the span of the frequency band of interest is 5Hz.

16. The method of claim 1, further comprising: in response to the presence of multi-channel collected bioelectric signals, determining whether to switch the stimulation scheme for each channel based on the bioelectric signal collected by each channel; in response to the multi-channels not simultaneously determining whether to switch the stimulation scheme, entering the stimulation phase for the channel that first determines whether to switch the stimulation scheme, while the other channels that have not determined whether to switch the stimulation scheme enter the stimulation phase according to the current stimulation scheme. ​ 17. The method of any one of claims 1-16, wherein the bioelectrical signal comprises a local field potential signal.

18. A neural stimulator comprising a stimulation module configured to perform the method of any one of claims 1-17.

19. An apparatus for switching stimulation protocols, comprising: a processor for executing program instructions; and a memory having the program instructions stored thereon, which when loaded and executed by the processor, cause the processor to perform the method of any one of claims 1-17. a computer readable medium having stored thereon computer readable instructions which, when executed by one or more processors, implement the method of any one of claims 1-17.

20. A computer-readable storage medium, characterized in that, ​

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