Nerve stimulator, control method of nerve stimulator, and storage medium

Abstract

The invention relates to a nerve stimulator, a control method of the nerve stimulator and a storage medium, and the nerve stimulator comprises a control unit which is used for controlling a signal generator; a signal generator for generating a stimulation signal, the energy of the stimulation signal satisfying an energy relationship, the energy relationship being accumulation of the charge with respect to time based on the waveform; and the output unit is used for outputting the stimulation signal. According to the application, the problem that the stimulation parameters of the stimulation equipment are easy to fail in adaptation is solved.

Description

Technical Field

[0001] This application relates to the field of electrical stimulation, and in particular to neurostimulators, methods for controlling neurostimulators, and storage media. Background Technology

[0002] Percutaneous vagus nerve stimulation (tVNS), as a non-invasive neuromodulation technique, applies electrical stimulation to branches of the vagus nerve via surface electrodes. In related techniques, the setting of the stimulation signal typically relies on the separate setting and adjustment of a series of discrete electrical parameters (such as pulse amplitude, frequency, and duty cycle). However, this approach makes the therapeutic effect highly dependent on the operator's experience and difficult to reproduce between different individuals or devices, thus easily affecting the stability of the stimulation signal output by the stimulation device.

[0003] Currently, no effective solution has been proposed to address the issue of low stability in the stimulation signals output by stimulation devices in related technologies. Summary of the Invention

[0004] This application provides a neurostimulator, a control method for the neurostimulator, and a storage medium to at least address the problem of low stability of the stimulation signal output by stimulation devices in related technologies.

[0005] In a first aspect, embodiments of this application provide a neurostimulator, comprising:

[0006] Control unit, used to control the signal generator;

[0007] A signal generator is used to generate a stimulus signal whose energy satisfies an energy relationship, which is the accumulation of charge based on the waveform over time.

[0008] An output unit is used to output the stimulation signal.

[0009] In some embodiments, the energy relationship is PT= Where PT represents the energy within one period, This represents a waveform function, where N represents the number of waveforms within one period. This indicates the duration of each waveform within one cycle. Indicates from 0 to Points earned during this period.

[0010] In some embodiments, if the waveform of the stimulus signal is a sine wave, then =E×sin(t); If the waveform is a square wave, then =±E; If the waveform is a triangular wave, then =E× Where E represents the signal strength and t represents the current time.

[0011] In some of these embodiments, N The calculation formula is: N =Duty cycle / Frequency;

[0012] The frequency ranges from 0.5 kHz to 20 kHz; and / or the duty cycle ranges from 5% to 45%.

[0013] In some embodiments, the control unit is further configured to determine a preset effective energy range of the stimulus signal based on the effective range or threshold of each parameter of the stimulus signal, according to the energy relationship;

[0014] The applied stimulation energy of the stimulation signal is controlled within the preset effective energy range.

[0015] In some embodiments, the preset energy effective range of the stimulation signal includes a first boundary and a second boundary; the value of the first boundary is smaller than the value of the second boundary;

[0016] The control unit includes:

[0017] An energy accumulator is used to accumulate the energy value of the output stimulus signal to obtain the applied stimulus energy.

[0018] A comparator is used to compare the applied stimulus energy with the first boundary and the second boundary;

[0019] A control subunit is configured to, in response to an output from the comparator indicating that the applied stimulus energy is less than the first boundary, control the signal generator to increase the stimulus duration and / or the number of stimulus cycles; and, in response to an output from the comparator indicating that the applied stimulus energy has reached or exceeded the second boundary, control the signal generator to stop outputting the stimulus signal.

[0020] In some embodiments, the control unit is also configured to maintain the energy of the stimulus signal constant during stimulus signal modulation based on the energy relationship.

[0021] In some embodiments, the signal generator is controlled to output a series of test stimulus signals, each of which has a different value for its stimulus parameter, but maintains a constant energy based on the energy relationship;

[0022] The control unit is communicatively connected to a user response interface and is also used to receive physiological response signals of the target object collected by the user response interface during the output of test stimulus signals.

[0023] The control unit is also used to determine the target configuration parameters from the stimulation parameters corresponding to the series of test stimulation signals according to the physiological response signals;

[0024] The signal generator is also configured to generate the stimulation signal in a controlled manner according to the target configuration parameters.

[0025] In some embodiments, it also includes:

[0026] A storage unit is used to store target adjustable parameter types; the target adjustable parameter types are determined by the control unit from the parameter types of the series of test stimulus signals based on the physiological response signals collected by the user response interface.

[0027] The control unit is also configured to, in response to a detected adjustment trigger command, control the signal generator to adjust the corresponding stimulation signal according to the target adjustable parameter type.

[0028] In some embodiments, in the series of test stimulus signals, the value of at least one stimulus parameter between adjacent signals changes monotonically, and the amount of change of the stimulus parameter between adjacent signals is a fixed value.

[0029] In some embodiments, the control unit is further configured to control the signal generator to output a determined stimulation duration and stimulation number according to a total energy configuration parameter generated based on the energy relationship; the stimulation duration and the stimulation number satisfy the energy relationship.

[0030] In some embodiments, the total energy configuration parameter is determined based on the energy relationship and a preset stimulation cycle requirement parameter.

[0031] In some embodiments, the control unit includes:

[0032] An energy accumulator is used to accumulate the energy value of the output stimulus signal to obtain the applied stimulus energy.

[0033] A comparator is used to compare the applied stimulus energy with the total energy configuration parameter;

[0034] A control subunit is configured to control the signal generator to stop outputting a stimulus signal in response to an output from the comparator indicating that the applied stimulus energy has reached the total energy configuration parameter.

[0035] In some embodiments, the control unit is communicatively connected to a user input interface and receives configuration instructions sent by the user input interface that characterize the physiological condition of the target object; the configuration instructions are used to instruct the adjustment of the total energy configuration parameters.

[0036] In some embodiments, it also includes:

[0037] A storage unit for storing reference stimulus energy generated based on reference parameter values ​​of the stimulus signal;

[0038] The control unit is configured to perform an energy relationship calibration mode;

[0039] In the energy relationship calibration mode, the control unit is also used to control the signal generator to adjust the reference stimulus energy to the target stimulus energy; the target stimulus energy indicates the energy reached by the stimulus signal under the energy relationship.

[0040] In some embodiments, in the energy relationship calibration mode, the signal generator is controlled to output a sequence of stimulation signals whose energy values ​​increase or decrease according to a preset energy step size.

[0041] The control unit is communicatively connected to a user response interface and is also used to receive physiological feedback signals from the target object collected by the user response interface during the output of the stimulus signal sequence; when the physiological feedback signal indicates that the current energy value exceeds a preset tolerance threshold, the current energy value is locked as the target stimulus energy.

[0042] Secondly, embodiments of this application provide a method for controlling a neurostimulator, including:

[0043] The control unit controls the signal generator to generate a stimulus signal, the energy of which satisfies an energy relationship, which is the accumulation of charge based on the waveform over time;

[0044] The output unit outputs the stimulation signal.

[0045] In some embodiments, the control unit controls the signal generator to generate stimulation signals, including:

[0046] The control unit determines the preset effective energy range of the stimulus signal based on the effective range or threshold of each parameter of the stimulus signal and in accordance with the energy relationship.

[0047] The applied stimulation energy of the stimulation signal is controlled within the preset effective energy range.

[0048] In some embodiments, the preset energy effective range of the stimulation signal includes a first boundary and a second boundary; the value of the first boundary is less than the value of the second boundary; the control unit includes an energy accumulator, a comparator, and a control subunit; the method further includes:

[0049] The energy accumulator accumulates the energy value of the output stimulus signal to obtain the applied stimulus energy;

[0050] The comparator compares the applied stimulus energy with the first boundary and the second boundary;

[0051] In response to the comparator's output indicating that the applied stimulus energy is less than the first boundary, the control subunit controls the signal generator to increase the stimulus duration and / or the number of stimulations; and in response to the comparator's output indicating that the applied stimulus energy has reached or exceeded the second boundary, controls the signal generator to stop outputting the stimulus signal.

[0052] In some embodiments, the control unit controls the signal generator to generate stimulation signals, including:

[0053] Based on the energy relationship, the control unit maintains the energy of the stimulus signal constant during the stimulation signal modulation process.

[0054] In some embodiments, the control unit maintains a constant energy level of the stimulus signal during stimulus signal modulation based on the energy relationship, including:

[0055] While the signal generator outputs a series of test stimulus signals under control, each of the series of test stimulus signals has a different value for its stimulus parameter, but the energy remains constant based on the energy relationship, the control unit receives the physiological response signal of the target object collected by the user response interface during the output of the test stimulus signal; the control unit is communicatively connected to the user response interface.

[0056] The control unit determines the target configuration parameters from the stimulation parameters corresponding to the series of test stimulation signals according to the physiological response signals, and controls the signal generator to generate the stimulation signals according to the target configuration parameters;

[0057] The signal generator is controlled to generate the stimulation signal according to the target configuration parameters.

[0058] In some embodiments, the control unit controls the signal generator to generate stimulation signals, including:

[0059] The control unit controls the signal generator to output a determined stimulation duration and stimulation number according to the total energy configuration parameters generated based on the energy relationship; the stimulation duration and the stimulation number satisfy the energy relationship.

[0060] In some embodiments, the control unit includes an energy accumulator, a comparator, and a control subunit; the control unit controls a signal generator to generate a stimulation signal, including:

[0061] The energy accumulator accumulates the energy value of the output stimulus signal to obtain the applied stimulus energy;

[0062] The comparator compares the applied stimulus energy with the total energy configuration parameter;

[0063] In response to the comparator's output indicating that the applied stimulus energy has reached the total energy configuration parameter, the control subunit controls the signal generator to stop outputting the stimulus signal.

[0064] In some embodiments, before the control unit controls the signal generator to generate a stimulation signal, the method further includes:

[0065] The storage unit stores the reference stimulus energy generated based on the reference values ​​of the parameter reference values ​​of the stimulus signal;

[0066] The control unit is configured to perform an energy relationship calibration mode;

[0067] In the energy relationship calibration mode, the control unit controls the signal generator to adjust the reference stimulus energy to the target stimulus energy; the target stimulus energy indicates the energy reached by the stimulus signal under the energy relationship.

[0068] In some embodiments, the control unit controls the signal generator to adjust the reference stimulus energy to the target stimulus energy, including:

[0069] In the energy relationship calibration mode, the signal generator is controlled to output a sequence of stimulation signals whose energy values ​​increase or decrease according to a preset energy step size;

[0070] The control unit receives physiological feedback signals from the target object collected by the user response interface during the output of the stimulation signal sequence; when the physiological feedback signal indicates that the current energy value exceeds a preset tolerance threshold, the current energy value is locked as the target stimulation energy; the control unit is communicatively connected to the user response interface.

[0071] Thirdly, embodiments of this application provide a storage medium storing a computer program thereon, which, when executed by a processor, implements the control method of the neurostimulator as described in the second aspect above.

[0072] Compared to related technologies, this application provides a neurostimulator, a control method for the neurostimulator, and a storage medium. The neurostimulator includes: a control unit for controlling a signal generator; a signal generator for generating a stimulation signal, wherein the energy of the stimulation signal satisfies an energy relationship, which is the accumulation of charge based on waveform over time; and an output unit for outputting the stimulation signal.

[0073] Based on this, it is possible to effectively avoid insufficient or excessive stimulation caused by improper adjustment of a single parameter, so that the stimulation process of the stimulation device always meets a precise, unified and physically based energy control relationship, thereby solving the problem of low stability of the stimulation signal output by the stimulation device.

[0074] Details of one or more embodiments of this application are set forth in the following drawings and description to make other features, objects and advantages of this application more readily apparent. Attached Figure Description

[0075] The accompanying drawings, which are included to provide a further understanding of this application and form part of this application, illustrate exemplary embodiments of this application and are used to explain this application, but do not constitute an undue limitation of this application. In the drawings:

[0076] Figure 1 This is a structural block diagram of a neurostimulator according to an embodiment of this application;

[0077] Figure 2 This is a waveform diagram of a stimulation signal according to an embodiment of this application;

[0078] Figure 3 This is a waveform diagram of another stimulation signal according to an embodiment of this application;

[0079] Figure 4 This is a structural block diagram of another neurostimulator according to an embodiment of this application. Detailed Implementation

[0080] To make the objectives, technical solutions, and advantages of this application clearer, the application is described and illustrated below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the application. All other embodiments obtained by those skilled in the art based on the embodiments provided in this application without inventive effort are within the scope of protection of this application. Furthermore, it is understood that although the efforts made in such a development process may be complex and lengthy, for those skilled in the art related to the content disclosed in this application, modifications to design, manufacturing, or production based on the technical content disclosed in this application are merely conventional technical means and should not be construed as insufficient disclosure of the content of this application.

[0081] In this application, the reference to "embodiment" means that a specific feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment that is mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described in this application may be combined with other embodiments without conflict.

[0082] Unless otherwise defined, the technical or scientific terms used in this application shall have the ordinary meaning understood by one of ordinary skill in the art to which this application pertains. The terms “a,” “an,” “an,” “the,” and similar words used in this application do not indicate quantity limitation and may indicate singular or plural. The terms “comprising,” “including,” “having,” and any variations thereof used in this application are intended to cover non-exclusive inclusion; for example, a process, method, system, product, or device that includes a series of steps or modules (units) is not limited to the listed steps or units, but may also include steps or units not listed, or may include other steps or units inherent to these processes, methods, products, or devices. The terms “connected,” “linked,” “coupled,” and similar words used in this application are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. “Multiple” used in this application means two or more. “And / or” describes the relationship between related objects, indicating that three relationships may exist; for example, “A and / or B” can represent: A alone, A and B simultaneously, and B alone. The terms “first,” “second,” “third,” etc., used in this application are merely to distinguish similar objects and do not represent a specific ordering of the objects.

[0083] As described in the background section, vagus nerve stimulation (VNS) is a treatment method that uses electrical stimulation of the vagus nerve to regulate the activity of the nervous system. It is widely used in the treatment of various diseases such as epilepsy, depression, and chronic pain.

[0084] Current VNS technology can be mainly divided into two major approaches: implantable and non-invasive. Among them, non-invasive vagus nerve stimulation offers the possibility of avoiding surgical risks and mainly covers two methods: transcutaneous cervical vagus nerve stimulation (tcVNS) and transauricular vagus nerve stimulation (taVNS). It can apply electrical stimulation to the corresponding positions in the neck or ear by using electrodes on the body surface.

[0085] However, optimizing and standardizing the stimulation parameters of existing VNS technologies, especially tcVNS and taVNS, remains a challenge in the field. Electrical stimulation waveforms involve several key parameters, including waveform morphology (such as sine, square, and triangular waves), frequency, duty cycle, stimulation intensity, duration of a single stimulation, and total stimulation duration. Different combinations of these parameters directly affect the efficiency of stimulation energy transfer, the selective activation of nerve fibers, and ultimately, the stimulation effect and safety.

[0086] Current technology lacks an optimization mechanism that can intelligently coordinate the above-mentioned multiple parameters to adapt to different individual physiological characteristics and disease states.

[0087] To address the aforementioned problems, embodiments of this application provide a neurostimulator. Figure 1 This is a structural block diagram of a neurostimulator according to an embodiment of this application, such as... Figure 1 As shown, the neurostimulator includes a control unit, a signal generation unit, and an output unit, wherein:

[0088] The control unit controls the signal generator; the signal generator generates stimulation signals whose energy satisfies an energy relationship, which is the accumulation of charge based on the waveform over time; the output unit outputs the stimulation signals.

[0089] It should be understood that the control unit's control over the signal generator is far more than a simple on / off command; it is a complex closed-loop process involving parameter setting, real-time monitoring, feedback adjustment, and safety management. In this embodiment, the control unit can receive internally preset stimulation parameter commands to configure the adjustment of the stimulation signal output by the signal generator. These parameters are a complete quantitative definition of the stimulation signal and may include, but are not limited to, the waveform type, duty cycle, stimulation frequency, and stimulation intensity of the stimulation.

[0090] The waveform types of stimulation signals can generally be categorized into square waves, triangle waves, and sine waves. Square wave signals are widely used in implantable VNS (Vibrational Nysfunction Syndrome); however, in tcVNS (Transcranial Vibration Syndrome), the rising and falling edges of the square wave may increase the patient's stimulation sensation. Triangle wave signals are widely used in electromuscular stimulation (EMS) for athletes. In VNS applications, triangle wave signals are suitable for young people, individuals with thick cortical tissue, and those with good tolerance. Sine wave signals, due to their slow rise and fall, produce a weaker stimulation sensation and are suitable for most people.

[0091] Frequency of the stimulus signal: Since neurons generate action potentials after responding to stimuli, and then cease responding to stimuli for a period of time (i.e., an absolute non-responsive period), the VNS requires a recovery time after the stimulus waveform. Therefore, the frequency of the VNS = 1 / (stimulation time + recovery time).

[0092] The duty cycle of the stimulus signal = stimulus time / (stimulation time + recovery time).

[0093] Stimulus intensity: When neurons are not stimulated, they are in a polarized state. Specifically, the inside of the neuron membrane has a negative voltage (typically -50 to -70 mV), while the outside of the membrane has a positive voltage or 0 V. To generate an action potential, depolarization is required, which involves applying a negative voltage (exceeding a certain threshold) outside the membrane, resulting in a positive inside and negative outside voltage. However, this threshold varies from individual to individual. Therefore, the stimulation intensity needs to be adjustable.

[0094] The duration of stimulation signals is generally 2 minutes in the morning and 2 minutes in the evening. However, it is possible to exceed this time range, and a model is needed for comprehensive management.

[0095] The total duration of stimulation signals: theoretically, the longer the better; however, excessively long stimulation duration may cause complications such as toothache and hoarseness. Therefore, if it is necessary to exceed a certain time range, the control unit needs to manage it comprehensively based on energy relationships.

[0096] Based on the above analysis, the control unit adjusts the stimulation parameters to ensure that the output energy of the stimulation signal generated by the signal generator always meets the energy relationship, thereby coordinating the configuration of each stimulation parameter.

[0097] It's also important to explain that neuronal activity, specifically the generation of action potentials, is essentially a charge transfer across the cell membrane caused by ion flow across the cell membrane—an electrochemical process. Therefore, charge is the ultimate physical quantity for activating or inhibiting neural activity. A stimulus signal must inject sufficient charge into the target tissue to depolarize the neuronal membrane potential to the threshold, thereby triggering a nerve impulse. How much charge is injected, and at what rate, is primarily determined by the waveform characteristics of the stimulus signal. These waveform characteristics refer first to the shape of the pulse, such as common square waves, sine waves, and triangular waves; secondly, they include key waveform parameters, including pulse amplitude (the intensity of current or voltage) and pulse width (the duration of each pulse). Ideally, the amount of charge carried by a single waveform is the product of its amplitude and width. This is the fundamental meaning of charge based on waveform.

[0098] However, the energy of a single waveform is often insufficient to produce a sustained neuromodulation effect, thus requiring continuous pulse application, which introduces the dimension of "cumulative time." In this implementation, this cumulative time is mainly reflected in the process of the neurostimulator outputting a single pulse signal, where the charge is based on the integration of the waveform over time.

[0099] In this embodiment, the specific process of the control unit controlling the signal generator to output stimulation signals begins with receiving and parsing preset stimulation parameter instructions. These parameters include stimulation amplitude, pulse width, stimulation frequency, and total stimulation duration, which together constitute the mathematical definition of the aforementioned energy relationship: "charge is based on the accumulation of waveform over time." The control unit can adjust the stimulation parameters according to the preset energy relationship to generate configuration parameters. More specifically, in this process, the control unit continuously monitors the actual output state of the stimulation waveform by the signal generator according to different sets of stimulation parameters, and calculates the integral value of the stimulation waveform function in the time domain in real time based on the aforementioned energy relationship. Therefore, the control unit can coordinately regulate various parameters of the stimulation signal, including stimulation intensity, stimulation frequency, waveform morphology, and duty cycle, while ensuring that the total charge transfer of the stimulation signal remains constant under different combinations of stimulation parameters, or that the accumulated total charge transfer within a certain time period (e.g., 24 hours) remains within a safe and effective range.

[0100] The control unit converts the aforementioned high-level parameter instructions regarding configuration parameters into low-level drive signals that the signal generator hardware can directly execute. For example, it sends specific digital codes to the digital-to-analog converter to set a precise voltage reference to control the output amplitude, uses a high-precision clock and counter to set the pulse width and interval to control the frequency, and manages the overall stimulation timing. Ultimately, this enables the signal generator to produce a stimulation signal that is precisely controlled in waveform morphology, temporal characteristics, and total energy, and the charge injection process of this signal completely follows a predetermined physical model based on the waveform's accumulation over time.

[0101] In addition, the aforementioned output unit can be one or more electrodes to ensure that the energy of the stimulation signal is transmitted from the device end to the tissue end with as little loss as possible.

[0102] By constructing a closed-loop control system for energy relationships based on the precise physical quantity "charge based on the accumulation of waveform over time" using the aforementioned neurostimulator, and taking the maintenance of this energy relationship as the highest criterion, the stimulation energy is unified into a calculable and traceable physical quantity. This ensures that the stimulation process of the stimulation device always meets a precise, unified, and physically-based energy control relationship, thereby effectively avoiding insufficient or excessive stimulation caused by improper adjustment of a single parameter, and solving the problem of low stability of the stimulation signal output by the stimulation device.

[0103] In some embodiments, the above energy relationship is shown in the formula:

[0104] PT= ;

[0105] In the above formula, PT represents the energy within one period. This represents a waveform function, where N represents the number of waveforms within one period. This indicates the duration of each waveform within one cycle. Indicates time points from 0 to Points earned during this period.

[0106] For a better understanding of this embodiment, please refer to Figure 2 The figure shows a waveform diagram of a single output pulse from a neurostimulator, where the horizontal axis represents time and the vertical axis represents electric field intensity. Figure 2 The pulse waveform shown consists of five waveforms, and the time interval between two adjacent peaks is the duration of each waveform within one cycle. Of course, in other embodiments, the number of waveforms in one cycle can be one or other values.

[0107] Please refer to the following. Figure 3 The figure shows waveforms for two consecutive cycles, with time represented on the horizontal axis and electric field intensity on the vertical axis. T represents the duration of one cycle. Since a cycle includes an absolute non-response period (i.e., a segment where the electric field intensity is 0 in the figure), the applied energy of the stimulus signal is zero during this period and can be disregarded in energy calculations. Therefore, when constructing the energy relationship, only the time points from 0 to N are considered. The energy points within this time period are sufficient.

[0108] In some exemplary embodiments, if the waveform of the stimulus signal is a sine wave, the calculation formula for the waveform function is as follows:

[0109] =E×sin(t);

[0110] If the waveform of the stimulus signal is a square wave, the formula for calculating the waveform function is as follows:

[0111] =±E;

[0112] If the waveform of the stimulus signal is a triangular wave, the formula for calculating the waveform function is as follows:

[0113] =E× ;

[0114] In the above formula, E represents the intensity of the stimulus signal (i.e., the amplitude of voltage or current), and t represents the current time.

[0115] In some exemplary embodiments, the maximum value at the current time during the integration process is based on N. Confirmed, N The calculation formula is:

[0116] N =Duty cycle / Frequency;

[0117] Optionally, the frequency range can be from 0.5 kHz to 20 kHz; and / or the duty cycle range can be from 5% to 45%.

[0118] Through the above embodiments, a method is constructed that explicitly defines the stimulus energy as a waveform function over a total time N. The integral within the model allows the control unit to automatically adjust the stimulation parameters based on the integral model as a constraint when the actual stimulation requirements change or when individual physiological differences (such as changes in tissue impedance) are encountered, effectively preventing tissue damage caused by charge imbalance.

[0119] In some embodiments, the control unit is further configured to determine a preset effective energy range of the stimulus signal based on the effective range or threshold of each parameter of the stimulus signal, according to the energy relationship; the applied energy of the stimulus signal is controlled within the preset effective energy range.

[0120] The effective range or threshold of each parameter of the aforementioned stimulation signal refers to the physical quantity boundary set for each adjustable stimulation parameter to ensure that neural stimulation can produce the expected stimulation effect while avoiding tissue damage or serious side effects. These boundaries are not arbitrarily set, but are strict limitations derived from the biophysical characteristics of neurons, the electrical characteristics of human tissues, and long-term clinical experience.

[0121] For a user receiving stimulation, individual stimulation parameters may have an effective range. Effective stimulation can only be achieved if the stimulation parameter falls within this effective range or exceeds a threshold. Conversely, if individual stimulation parameters are outside this effective range or below the threshold, effective stimulation will not be achieved even if other stimulation parameters are too large. For example, if the stimulation intensity E is very small, even if the stimulation duration, duty cycle, and frequency are too large, the stimulation effect will be negligible, and effective stimulation will not be achieved. Conversely, if the frequency f of the stimulation signal is very small, it will not be able to penetrate the user's skin at all.

[0122] Based on the above analysis, the effective range of each stimulus parameter and the formula PT = Calculate the effective range of PT (P T0 P T1Alternatively, calculate the effective minimum value P of PT based on the effective minimum value of each stimulus parameter. T0 .

[0123] Taking TCVNS technology as an example, the effective range of the stimulation intensity E of the stimulation signal can be an effective range of voltage amplitude from 5V to 20V; the effective range of the waveform shape of the stimulation signal can be sine wave, square wave, and triangle wave; the effective range of frequency is 0.5kHz to 20kHz; and the effective range of duty cycle is 5% to 45%. Thus, substituting the upper and lower limits of the parameters into the aforementioned unified energy relationship formula PT = In this process, the preset effective energy range that the stimulation energy of the stimulus signal can reach can be calculated; within this effective energy range, the stimulation applied by the stimulator should be able to ensure safety and effectiveness.

[0124] Specifically, the control unit can read in real time the effective range or safety threshold of each stored or user-defined stimulation parameter (such as current amplitude, pulse width, and frequency). These parameters are then used as input variables and substituted into the aforementioned unified energy relationship formula for real-time calculation, thereby dynamically deriving the globally preset effective energy range (P). T0 P T1 This ensures an absolute match between the energy range and the current parameter settings.

[0125] Alternatively, in another embodiment, the control unit can directly call up a pre-determined and fixed preset energy effective range from the built-in non-volatile memory. These ranges are also calculated using the energy formula described above based on standardized parameter effective thresholds.

[0126] During the application of stimulation, the control unit continuously integrates the waveform of the output stimulation signal in real time and dynamically calculates the cumulative value of the applied energy to implement closed-loop control, ensuring that the cumulative energy is always higher than P. T0 To prevent the stimulus from being ineffective, for example, if it is near P T0 However, if the target is not met, you can be prompted to adjust the parameters; at the same time, ensure that the cumulative energy is always within P. T1 Within this upper limit, if a risk arises due to prolonged stimulation duration or improper parameter settings, the control unit will proactively intervene, such as lowering the current stimulation parameter configuration or pausing the output.

[0127] Through the above embodiments, the control unit calculates the global preset effective energy range (P) by substituting the effective range of each parameter (such as intensity and frequency) into the energy relationship model. T0 P T1Based on this, by monitoring the applied energy in real time and implementing closed-loop control, it is ensured that the energy is always within the preset effective range. This elevates the stimulation from isolated parameter adjustment to intelligent overall stimulation energy management, effectively preventing stimulation failure caused by any parameter being too low, while also preventing the risk of excessive energy, and systematically solving the problem of improper parameter matching.

[0128] In some embodiments, the preset energy effective range of the stimulation signal includes a first boundary and a second boundary; the value of the first boundary is less than the value of the second boundary. The first boundary is the lower limit P of the preset energy effective range. T0 The second boundary is the upper limit P of the preset effective energy range. T1 .

[0129] Please see Figure 4 The aforementioned control unit includes an energy accumulator, a comparator, and a control subunit, wherein:

[0130] An energy accumulator is used to accumulate the energy value of the output stimulus signal to obtain the applied stimulus energy. Specifically, the energy accumulator performs a physical or mathematical integration operation by continuously sampling and analyzing the stimulus signal actually output by the signal generator and transmitted through the output unit (electrodes). Since the energy relationship of the stimulus signal is defined as "the accumulation of charge based on the waveform over time," the accumulator essentially works by integrating the stimulus waveform function over time.

[0131] In practical implementation, the energy accumulator can be implemented either through dedicated analog hardware circuits (such as an operational amplifier-based integrator) or as a software program running as a virtual unit within the microprocessor core. In hardware implementation, the accumulated energy value can be directly obtained by continuously integrating the voltage representing the stimulus signal. In software implementation, an algorithm in the firmware can periodically sample stimulus parameters (such as current amplitude, pulse width, and frequency) and perform discrete digital integration based on the energy relationship of "charge accumulation based on waveform over time," thereby updating the accumulated value of the applied stimulus energy in memory.

[0132] A comparator is used to compare the applied stimulus energy with a first boundary and a second boundary. Similar to an accumulator, a comparator can exist in hardware or software: a hardware implementation can be a fast voltage comparator chip that directly compares the analog voltage representing the energy with a reference voltage representing the boundary; a software implementation is a simple conditional statement in a program.

[0133] The control subunit is configured to, in response to a comparator output indicating that the applied stimulus energy is less than a first boundary, control the signal generator to increase the stimulus duration and / or the number of stimulus cycles; and, in response to a comparator output indicating that the applied stimulus energy has reached or exceeded a second boundary, control the signal generator to stop outputting the stimulus signal.

[0134] First, when the comparator output indicates "the applied stimulation energy is less than the first boundary," it means that the current stimulation energy may be insufficient to achieve the desired effect. Therefore, the control subunit can instruct the signal generator to intelligently increase the total energy output. This increase in energy output can be achieved through two main strategies: one is to increase the stimulation duration, that is, to extend the duration of a single stimulation beyond the original plan; the other is to increase the number of stimulations, for example, increasing the number of stimulations per day in an intermittent stimulation mode. This solves the problem of insufficient stimulation caused by overly conservative initial parameter settings or individual differences, and helps to ensure the basic effectiveness of neural stimulation. Second, when the comparator outputs an alarm "the applied stimulation energy has reached or exceeded the second boundary," it indicates that the total energy output has entered a danger zone, with a clear risk of tissue damage or side effects. At this time, the control subunit will activate the highest level of safety protection mechanism and immediately instruct the signal generator to stop outputting stimulation signals.

[0135] It should also be understood that when the applied energy is within the range of the first and second boundaries, that is, when the applied energy is greater than the first boundary and less than the second boundary, the control unit can ensure that the output stimulation energy is always kept within the range of the boundaries by fine-tuning the stimulation parameters of the stimulation signal.

[0136] Through the above embodiments, not only can the stimulation energy be actively ensured to reach an effective level, but it can also be constrained within an absolutely safe range, thereby greatly improving the safety and reliability of nerve stimulation.

[0137] It should also be noted that in related technologies, stimulation devices often use preset waveforms and fixed parameter settings (such as pulse amplitude, frequency and duty cycle). However, for different target objects to be stimulated, their individual physiological differences (such as nerve sensitivity, skin impedance, etc.) will make the stimulation effect under the same parameters significantly different, which will cause the stimulation parameters of the stimulation device to easily fail to adapt.

[0138] To improve the above-mentioned problems, in some other embodiments, the control unit is also used to maintain the energy of the stimulus signal constant during the stimulation signal modulation process based on the energy relationship.

[0139] Specifically, the control unit can dynamically adjust the output parameters of the signal generator. For example, if the adjustment involves time-domain parameters such as pulse width, frequency, or waveform shape, the control unit performs equivalent calculations based on an energy relationship model, reconfiguring the parameter combinations while maintaining the total energy constant (e.g., increasing the amplitude when reducing the pulse width, or increasing the frequency when reducing the duration of a single pulse). The entire process forms a high-bandwidth negative feedback control loop, ensuring that regardless of changes in external conditions, the energy accumulation rate and final total energy output of the stimulus signal output by the signal generator strictly adhere to the preset energy target. Thus, while maintaining a constant stimulus signal energy, the control unit can collaboratively adjust multiple sets of stimulus parameter configurations, providing an effective multi-parameter coordination mechanism. This solves the problem of stimulus energy fluctuations that are susceptible to physiological changes or individual / environmental interference, ensuring the stability and repeatability of the neuromodulation effect during the coordination of multiple stimulus parameters.

[0140] In some embodiments, the signal generator is controlled to output a series of test stimulus signals. Each signal in the series has a different value for its stimulus parameters, but the energy remains constant based on an energy relationship. Specifically, the control unit configures and continuously adjusts the stimulus parameters of the stimulus signals to control the signal generator to generate and output a series of test stimulus signals. This series of test stimulus signals is characterized in that, although the specific stimulus parameters (e.g., stimulus intensity, pulse width, frequency, etc.) of each signal are different, the output stimulus energy is always maintained at a constant level based on the energy relationship of "charge based on waveform accumulation over time."

[0141] For example, when the control unit commands the signal generator to output a test signal with a narrow pulse width, it will simultaneously and proportionally increase the current or voltage amplitude of that signal; conversely, when testing a higher frequency signal, the control unit will correspondingly reduce the amplitude or width of a single pulse. Through this coordinated adjustment of parameters, it is ensured that regardless of parameter changes, the total charge or energy injected into the target object by each test signal per unit time remains essentially consistent.

[0142] The aforementioned control unit is communicatively connected to a user response interface and is also used to receive physiological response signals of the target object collected by the user response interface during the output of test stimulus signals; the control unit is also used to determine target configuration parameters from stimulus parameters corresponding to a series of test stimulus signals according to the physiological response signals.

[0143] The aforementioned user response interface can be a simple button (providing subjective feedback of discomfort or sensory changes from the stimulated user, i.e., the target object), or it can be a device such as an electromyography sensor, a heart rate variability monitor, or a camera to monitor the user's real-time physiological responses. For example, this interface can be implemented using a camera device. The control unit can receive a series of video frame images of the target object during the stimulation test, and analyze the degree of drooping of the user's mouth in the video frame images (a sign that the vagus nerve has been effectively stimulated) to determine the user's real-time response.

[0144] The control unit communicates with the user response interface (such as an electromyography sensor or camera device used to monitor drooping corners of the mouth) to receive objective physiological response signals of the target object collected during the output of test stimulus signals, and uses this as a basis to gradually adjust and determine the final target configuration parameters.

[0145] It is understandable that adjusting any of the stimulation parameters will change the stimulation energy. However, everyone's tolerance is different; some users tolerate low stimulation intensity E, while others tolerate high stimulation intensity E; some users can tolerate high duty cycles, while others can only tolerate low duty cycles. Therefore, in order to meet the individual needs of more users while ensuring sufficient stimulation effect (i.e., sufficient stimulation energy within the aforementioned effective energy range), this application provides the following exemplary testing scheme:

[0146] The control unit first instructs the signal generator to output a test signal with a set of fixed parameters (e.g., frequency of 5kHz, duty cycle of 0.25%, i.e., Nτ=1ms, N=5, τ=200us, sine wave output, and recording the stimulation intensity E of each person's drooping corner of the mouth). At this time, the control unit accurately calculates the energy value required to trigger the effective response based on a unified energy relationship model, thereby establishing a unique "stimulation model" for that individual.

[0147] Specifically, the control unit adjusts different types of stimulation parameters in sequence, gradually constructs a series of test stimulation signals composed of various sets of stimulation parameters, and searches for and finds the optimal stimulation parameter configuration in this process.

[0148] For example, the control unit can first adjust the duty cycle stimulus parameter to determine if the individual has a maximum response to the duty cycle. The duty cycle is increased and decreased separately. After each adjustment, the total energy and stimulus model are kept constant according to the energy consistency principle through three different compensation modes (e.g., adjusting waveform, adjusting frequency, and adjusting stimulus intensity E). Test signals for each of these three modes are output, and the intensity of the drooping corner of the mouth response is collected and recorded through the user response interface for each mode. At this point, the first round of configuration optimization for the duty cycle stimulus parameter is output.

[0149] After completing the duty cycle configuration optimization test, the control unit performs the same adjustment and testing cycle on the frequency to determine whether the individual has a maximum response to the frequency. While increasing or decreasing the frequency, energy compensation is also performed and the response is tested by adjusting the waveform, duty cycle, or stimulus intensity E. Throughout the process, the control unit continuously compares the amplitude of the physiological response signals collected under all test modes (including the benchmark test), and automatically analyzes the parameter combination (such as finding the response peak) to determine which parameter combination results in the most obvious and stable drooping of the target object's corner of the mouth when the signal generator generates the test stimulus signal and outputs it to the target object.

[0150] It should also be understood that although the above example only illustrates two test cycles, the number of test cycles should be adjustable according to actual circumstances or needs. For example, if, through the above two rounds of testing, the target object's drooping mouth response under a certain set of stimulus parameters is detected to be more pronounced than that under other stimulus parameter combinations under a series of test adjustments, and the control unit receives positive feedback from the target object indicating good tolerance through other interfaces (such as buttons), or determines that the difference between the current physiological response signal amplitude and the historical physiological response signal amplitude of the target object is greater than a certain threshold, then it indicates that the configuration combination of stimulus parameters can still be further optimized. Therefore, another set of tests (such as adjusting the stimulus intensity) can be started based on these two test cycles. Alternatively, if the control unit receives positive feedback from the target object indicating intolerable behavior after implementing one test cycle, it can end the test directly to avoid over-optimization.

[0151] On the other hand, the execution order of the above-mentioned multi-round test cycle is only an example; in fact, during the test process, stimulation parameters such as frequency can be tested first, or multiple stimulation parameter adjustment tests can be started at the same time, which is not limited here.

[0152] Finally, the set of parameters that produce the maximum physiological response determined during the above test cycle is selected as the target configuration parameters, thereby completing the transformation from the general stimulation parameter configuration in related technologies to the precise stimulation parameter configuration for individual optimal solutions.

[0153] The aforementioned signal generator is also used to generate stimulus signals in a controlled manner according to the target configuration parameters. In other words, after the control unit successfully determines the target configuration parameters, it indicates that the user currently receiving the stimulus has a good acceptance of the stimulus under the target configuration parameters, and therefore the stimulus execution phase can proceed according to the target configuration parameters.

[0154] At this point, the signal generator is once again under the control of the control unit, but the instructions have switched from the previous test mode to a fixed stimulation mode. The control unit transmits the finalized set of target configuration parameters (e.g., optimal stimulation intensity of 15V, optimal frequency of 5kHz, and optimal duty cycle of 25%) to the signal generator. The signal generator then generates the stimulation signal for subsequent formal stimulation execution according to this set of target configuration parameters, which has been verified to be most effective and comfortable for the specific user.

[0155] Through the above embodiments, under the constraint of maintaining a constant total energy, the control unit determines the target configuration parameters from a series of continuously adjusted test stimulus signals based on the physiological response signals of the target object monitored in real time. This ensures that the characteristic parameters (such as waveform and frequency) of the stimulus signals during the stimulus execution phase are always optimized to the most effective state for the user, and achieves adaptive optimal configuration of each stimulus parameter.

[0156] It should also be noted that although the target stimulation parameters are configured via the control unit in the above manner, fine-tuning of the stimulation parameters may be necessary considering the differences in stimulation progress among different individuals during stimulation execution. Therefore, in some embodiments, the aforementioned neurostimulator may further include:

[0157] The storage unit is used to store the target adjustable parameter type; the target adjustable parameter type is determined by the control unit from the parameter types of a series of test stimulus signals based on the physiological response signals collected by the user response interface.

[0158] The aforementioned control unit is also used to adjust the corresponding stimulation signal of the control signal generator according to the target adjustable parameter type in response to the detected adjustment trigger command.

[0159] More specifically, after executing the aforementioned parameter optimization process, the control unit, based on the physiological response signals (such as electromyography, heart rate variability, or drooping corner of the mouth) collected by the user response interface, comprehensively analyzes and determines the category of signal parameters that can most induce the ideal physiological response for the specific target object from multiple sets of signal parameters covered by a series of test stimulus signals, and stores them in a preset storage unit.

[0160] For example, if the physiological response signal changes most significantly when the current target object changes its duty cycle through a series of tests, the duty cycle can be determined as the target adjustable parameter type, and the optimal value of the duty cycle (such as 20%) determined by the control unit in this process can be stored in a preset storage unit.

[0161] Thus, when the control unit initiates further adjustments to the stimulation parameter configuration of the target object during subsequent stimulation execution in response to a detected adjustment trigger command (which may originate from a device timer, user's active manual input, or an adaptive request automatically triggered by the real-time physiological signal analysis module), it does not perform a time-consuming full parameter scan again. Instead, it directly reads the "target adjustable parameter type" specific to that target object pre-stored in the storage unit and precisely controls the signal generator accordingly. More specifically, at this time, the control unit can, based on the aforementioned unified energy relationship and ensuring that the stimulation energy remains constant, prioritize increasing the stimulation parameter configuration value indicated by the target adjustable parameter type (e.g., increasing the duty cycle from 20% to 25%), while fine-tuning other stimulation parameters, thereby achieving fine-tuning of the stimulation energy without deviating from the proven most effective stimulation mode.

[0162] By employing the above methods, it is ensured that the device can respond to changes in user status or evolving stimulation needs during long-term use, making necessary parameter adjustments while remaining anchored within the individualized optimal stimulation window. This avoids the degradation of stimulation effects caused by blind adjustments, significantly improving the long-term stability of neural stimulation and the user experience.

[0163] In some embodiments, in the series of test stimulus signals described above, the value of at least one stimulus parameter (e.g., stimulus intensity, frequency, pulse width, or duty cycle) between adjacent signals changes monotonically, and the amount of change of the stimulus parameter between adjacent signals is a fixed value.

[0164] Taking the duty cycle η as an example, with a fixed step size of 2%, the test sequence will be η1, η2 = η1 + 2%, η3 = η2 + 2%, ..., forming an arithmetic sequence of parameters. This combination of monotonicity and fixed step size avoids random jumps or repetitions of test points, enabling the control unit to clearly establish the correspondence curve between the intensity of the physiological response (such as the degree of drooping of the corner of the mouth) and this monotonically changing parameter when receiving physiological response signals from the user's response interface. This allows for accurate location of the peak or threshold point of the response curve (such as the intensity value corresponding to the maximum response). This not only greatly improves the efficiency and reliability of searching for target configuration parameters but also provides high-quality, high signal-to-noise ratio input data for the control unit to finally determine the target configuration parameters.

[0165] In some embodiments, the control unit is further configured to control the signal generator to output a determined stimulation duration and number of stimulations according to the total energy configuration parameters generated based on the energy relationship; the stimulation duration and number of stimulations satisfy the energy relationship.

[0166] Specifically, the stimulation energy within a period T, denoted as PT, can be calculated using the energy relationship formula described above. Taking each day as a long period, the total stimulation energy for each day (i.e., the total energy configuration parameter mentioned above) is calculated. This effectively pre-stores the maximum total stimulation energy for a fixed long period (exceeding the maximum stimulation energy may lead to complications); subsequently, the user can adjust the stimulation duration or number of stimulations according to their own schedule, or the control unit can adaptively adjust it, as long as the energy applied within that fixed long period does not exceed the total energy configuration parameter.

[0167] For example, the control unit can set a stimulation model with a fixed stimulation duration, such as twice a day for 2 minutes each time. Of course, the stimulation energy applied based on this stimulation model is within the range of the total energy configuration parameters determined based on the energy relationship mentioned above.

[0168] Alternatively, the control unit can be set to a stimulation model that controls the duration of stimulation based on the total amount, such as limiting the number of stimulations to 20 per day. Once 20 stimulations are reached, it can only be used again after 24 hours, with each stimulation lasting 2 minutes. This indicates that the maximum total stimulation duration per day is 40 minutes. Therefore, the parameters can be adjusted appropriately. For example, if each stimulation lasts 4 minutes, then a maximum of 10 stimulations can be performed per day; and so on.

[0169] Alternatively, the control unit can also use frequency modeling; for example, the total number of times can be controlled at 600. After one stimulation course is completed, the operator decides whether to start the next stimulation course.

[0170] Through the above embodiments, the stimulation duration and / or number of stimulations can be flexibly adjusted within the total stimulation energy range, effectively improving the reliability of stimulation energy control and the predictability of stimulation results.

[0171] In some embodiments, the total energy configuration parameters are determined based on the energy relationship and preset stimulation cycle requirements.

[0172] In other words, the above total energy configuration parameters are calculated based on the fundamental energy relationship that "charge is accumulated over time based on waveform," combined with preset stimulation cycle requirements. The calculation process is explained below: First, the base energy PT within a single stimulation cycle T is determined according to the energy relationship; then, the required duration t for a single stimulation over a fixed long period (e.g., within 24 hours) is calculated. 次 Calculate the total energy P of the stimulus within this fixed long period. 次 =(t 次 / T) PT; Finally, based on the daily stimulation frequency requirement parameter N, determine the total energy allocation parameter P for the cycle. 总 = P 次 ×N=(t 次 / T)×PT×N. For example, assuming the period T=1ms, if the duration of each stimulus t is 2 minutes = 120s, then there are a total of 120,000 stimulus periods, and the total stimulus energy P for each stimulus is... 次 =120000×PT, i.e., P 次 =t 次 / T×PT. If the number of stimulations per day is N, then the total stimulation energy P per day is... 总 =P 次 ×N=t 次 / T×PT×N.

[0173] The control unit acquires this P 总 Then, its control logic transforms into ensuring that the signal generator accurately satisfies P within the specified period. 总 The control objective for this total energy configuration parameter. This is based on a hierarchical algorithm model (from periodic energy PT, to single-cycle energy P). 次 Then, the total energy P of the cycle 总 The control method enables a scale leap from micro-pulses to macro-stimulation execution schemes, allowing the device to systematically and predictably manage long-term stimulation energy, providing a key technical foundation for achieving standardized and quantifiable neuromodulation.

[0174] In some embodiments, the control unit described above includes:

[0175] An energy accumulator is used to accumulate the energy value of the output stimulus signal to obtain the applied stimulus energy.

[0176] A comparator is used to compare the applied stimulus energy with the total energy configuration parameters;

[0177] The control subunit is used to control the signal generator to stop outputting the stimulus signal in response to the comparator's output indicating that the applied stimulus energy has reached the total energy configuration parameter.

[0178] Specifically, in this neurostimulator, the energy accumulator acts as an energy monitoring unit, performing real-time energy integration on each stimulation pulse output by the signal generator through a hardware integration circuit or software algorithm. It should also be noted that, in this embodiment, the accumulated applied stimulation energy should be the sum of stimulation energy over a fixed long period (e.g., within 24 hours).

[0179] Next, the comparator compares the real-time accumulated value provided by the energy accumulator with the preset total energy configuration parameters using hardware circuitry or software algorithms. When the real-time accumulated value is less than P... 总 When the cumulative value reaches (equals to or first exceeds) P, the comparator outputs a "continue" state, allowing the stimulus to continue. 总 The comparator immediately flips its output state, issuing a "target achieved" trigger signal. The control subunit, as the final actuator, has its logic circuitry or control program designed to respond to this trigger signal: upon receiving it, it immediately sends a hard stop or soft shutdown command to the signal generator, cutting off the enable signal of the power output stage, thereby forcibly interrupting the generation of the stimulus signal.

[0180] The above methods fundamentally ensure the accuracy of the stimulation energy and the safety of the stimulation process, which is a key technological guarantee for achieving precise neuromodulation.

[0181] In some embodiments, the control unit is communicatively connected to a user input interface and receives configuration instructions sent by the user input interface that characterize the physiological condition of the target object; the configuration instructions are used to instruct the adjustment of total energy configuration parameters.

[0182] Specifically, the control unit establishes a communication connection with a user input interface, which is used to receive input operations from clinicians or authorized users. These operations do not directly set specific parameters, but rather send a higher-level configuration command that characterizes the current physiological state of the target object (such as the effect of stimulation).

[0183] Upon receiving this instruction, the control unit will treat it as an adjustment factor and apply it to the preset or calculated baseline total energy configuration parameters (P). 总 For example, the system has a pre-set adjustment model related to the degree of stimulus effect: when the configuration command indicates that the stimulus effect on the target object is "moderate", the control unit will increase the baseline total energy configuration parameter by 10% according to the model, that is, execute P. 总新 =P 总基准× (1 + 10%) to apply a stronger stimulus; conversely, if the instruction indicates "good", the control unit will decrease by 10%, i.e., execute P. 总新 =P 总基准 ×(1 - 10%) to avoid overstimulation.

[0184] Through the above embodiments, the configuration command, as a high-level decision input, indirectly but precisely guides the final determination of the total energy configuration parameters, enabling the stimulation energy to be flexibly and quantitatively adapted to the constantly changing stimulation conditions of the target object. This achieves an upgrade from a fixed energy scheme to a personalized, adaptive energy scheme, thereby ensuring stimulation safety and potentially achieving stimulation optimization for target objects of different severity levels.

[0185] In some embodiments, the above-described neurostimulator further includes:

[0186] A storage unit for storing reference stimulus energy generated based on reference parameter values ​​of the stimulus signal;

[0187] The control unit is configured to perform an energy relationship calibration mode;

[0188] In the energy relationship calibration mode, the control unit is also used to control the signal generator to adjust the reference stimulus energy to the target stimulus energy; the target stimulus energy indicates the energy reached by the stimulus signal under the energy relationship.

[0189] The aforementioned baseline stimulus energy is calculated from the baseline values ​​of various parameters of the stimulus signal (such as frequency, duty cycle, stimulus intensity, etc. under standard conditions) using the unified energy relationship formula mentioned above; this value represents the initial parameter value when the test of regulating the stimulus parameters begins.

[0190] Considering that during the coordination of various parameters of the test stimulus signal, the stimulus parameters will be adjusted multiple times according to the energy relationship, while ensuring that the stimulus energy value of a single output stimulus remains constant, the stimulus energy will remain unchanged. However, this may result in the energy value calculated based on the preset parameter benchmark value being too large or too small, or not optimal, for different target objects. Therefore, the initially calculated benchmark stimulus energy value can be adjusted to achieve further optimization.

[0191] The control unit is configured to execute a specific energy relationship calibration mode. In this mode, the control unit reads the reference stimulus energy from the storage unit and uses it as a reference to adjust the stimulus energy to the target stimulus energy. In this way, by adjusting the stimulus parameters, the control unit controls the stimulus energy that can be applied by the stimulus signal generated by the signal generator to always maintain the same value as the target stimulus energy.

[0192] Through the above embodiments, the calibration of the energy relationship is completed, avoiding the problem that the initial stimulus energy setting is prone to deviation, and further improving the adaptability of stimulus parameter configuration for different target users.

[0193] It should also be understood that the storage unit used to store the reference stimulus energy and the storage unit used to store the target adjustable parameter type may be the same storage device.

[0194] In some embodiments, in energy relationship calibration mode, the signal generator is controlled to output a sequence of stimulation signals whose energy values ​​increase or decrease according to a preset energy step size.

[0195] The control unit is connected in communication with a user response interface and is also used to receive physiological feedback signals from the target object collected by the user response interface during the output of the stimulus signal sequence; when the physiological feedback signal indicates that the preset tolerance threshold is exceeded, the current energy value is locked as the target stimulus energy.

[0196] Specifically, under the precise instructions of the control unit, the aforementioned signal generator outputs a stimulation signal sequence whose energy value monotonically increases or decreases according to a preset fixed step size (such as increasing by 0.1 mA equivalent charge each time). This sequence constitutes a systematic energy scanning test.

[0197] Simultaneously, the control unit continuously receives physiological feedback signals from the target object (such as subjective pain scores, muscle twitch potentials, or heart rate mutation signals) collected during the output of the stimulation signal sequence through real-time communication with the user's response interface (such as a pain feedback button, electromyography sensor, or autonomic nervous system response monitor). The control unit has a preset tolerance threshold. When the intensity or characteristics of the received physiological feedback signal indicate that the stimulation energy has reached or exceeded this preset tolerance threshold (e.g., the patient presses a button indicating discomfort, or the sensor detects a clear stress response), the control unit immediately performs a locking operation, recording and confirming the energy value corresponding to the current stimulation signal as the final target stimulation energy.

[0198] By using the above method, the physical energy output by the device is directly linked to the individual user's physiological experience. The personalized energy safety limit is automatically determined through objective feedback signals, ensuring that the subsequent stimulation energy is as close as possible to the effective energy and will never exceed the user's tolerance limit. This ensures the effectiveness of stimulation while guaranteeing the safety of stimulation.

[0199] Based on the same inventive concept, this application also provides a control method for a neurostimulator. The solution provided by this neurostimulator control method is similar to the solution described in the aforementioned device. Therefore, the specific limitations in the control method embodiments for one or more neurostimulators provided below can be found in the limitations of the neurostimulator described above, and will not be repeated here.

[0200] This embodiment provides a control method for a neurostimulator, applied to any of the neurostimulators described above. The method includes the following steps:

[0201] The control unit controls the signal generator to generate a stimulus signal. The energy of the stimulus signal satisfies an energy relationship, which is the accumulation of charge based on the waveform over time. The output unit outputs the stimulus signal.

[0202] In some embodiments, the control unit controlling the signal generator to generate stimulation signals may further include the following steps:

[0203] The control unit determines the preset effective energy range of the stimulus signal based on the effective range or threshold of each parameter of the stimulus signal and according to the energy relationship.

[0204] The applied stimulus energy of the stimulus signal is controlled within a preset effective energy range.

[0205] In some embodiments, the preset energy effective range of the stimulation signal includes a first boundary and a second boundary; the value of the first boundary is less than the value of the second boundary; the control unit includes an energy accumulator, a comparator, and a control subunit; the process of controlling the applied stimulation energy of the stimulation signal within the preset energy effective range may further include the following steps:

[0206] The energy accumulator accumulates the energy value of the output stimulus signal to obtain the applied stimulus energy;

[0207] The comparator compares the applied stimulus energy with the first boundary and the second boundary;

[0208] In response to the comparator's output indicating that the applied stimulus energy is less than the first boundary, the control subunit controls the signal generator to increase the stimulus duration and / or the number of stimuli; and in response to the comparator's output indicating that the applied stimulus energy has reached or exceeded the second boundary, the control signal generator stops outputting the stimulus signal.

[0209] In some embodiments, the control unit controlling the signal generator to generate stimulation signals may further include the following steps:

[0210] The control unit maintains a constant energy level for the stimulus signal during the stimulation signal modulation process, based on the energy relationship.

[0211] In some embodiments, the control unit, based on energy relationships, maintains a constant energy level for the stimulus signal during stimulus signal modulation, and may further include the following steps:

[0212] The signal generator outputs a series of test stimulus signals under control, where the stimulus parameters of each signal in the series of test stimulus signals are different, but the energy is kept constant based on the energy relationship. The control unit receives the physiological response signals of the target object collected by the user response interface during the output of the test stimulus signals; the control unit is communicatively connected to the user response interface.

[0213] The control unit determines the target configuration parameters from the stimulation parameters corresponding to a series of test stimulation signals based on the physiological response signals;

[0214] The signal generator is controlled to generate stimulus signals according to the target configuration parameters.

[0215] In some embodiments, the above method may further include the following steps:

[0216] The control unit determines the target adjustable parameter type from the various parameter types of a series of test stimulus signals based on the physiological response signals collected by the user response interface.

[0217] The control unit responds to the detected adjustment trigger command and adjusts the corresponding stimulation signal by controlling the signal generator according to the target adjustable parameter type.

[0218] In some embodiments, in a series of test stimulus signals, the value of at least one stimulus parameter between adjacent signals changes monotonically, and the amount of change of the stimulus parameter between adjacent signals is a fixed value.

[0219] In some embodiments, the control unit controlling the signal generator to generate stimulation signals may further include the following steps:

[0220] The control unit controls the signal generator to output a determined stimulation duration and number of stimulations according to the total energy configuration parameters generated based on the energy relationship; the stimulation duration and number of stimulations satisfy the energy relationship.

[0221] In some embodiments, the control unit includes an energy accumulator, a comparator, and a control subunit; the control signal generator generates a stimulation signal and may further include the following steps:

[0222] The energy accumulator accumulates the energy value of the output stimulus signal to obtain the applied stimulus energy;

[0223] The comparator compares the applied stimulus energy with the total energy configuration parameter;

[0224] The control unit controls the subunit in response to the comparator's output indicating that the applied stimulus energy has reached the total energy configuration parameter, and then controls the signal generator to stop outputting the stimulus signal.

[0225] In some embodiments, the above method may further include the following steps:

[0226] The control unit receives configuration instructions representing the physiological condition of the target object sent by the user input interface; the configuration instructions are used to instruct the adjustment of the total energy configuration parameters; wherein, the control unit is communicatively connected to the user input interface.

[0227] In some embodiments, before the control unit controls the signal generator to generate the stimulation signal, the above method may further include the following steps:

[0228] The storage unit stores the reference stimulus energy generated based on the reference values ​​of the parameter reference values ​​of the stimulus signal;

[0229] The control unit is configured to perform an energy relationship calibration mode;

[0230] In energy relationship calibration mode, the control unit controls the signal generator to adjust the reference stimulus energy to the target stimulus energy; the target stimulus energy indicates the energy reached by the stimulus signal under the energy relationship.

[0231] In some embodiments, the control unit controlling the signal generator to adjust the reference stimulus energy to the target stimulus energy may further include the following steps:

[0232] In energy relationship calibration mode, the signal generator outputs a sequence of stimulation signals whose energy values ​​increase or decrease according to a preset energy step size.

[0233] The control unit receives physiological feedback signals from the target object collected by the user response interface during the output of the stimulus signal sequence; when the physiological feedback signal indicates that the preset tolerance threshold is exceeded, the current energy value is locked as the target stimulus energy; the control unit is communicatively connected to the user response interface.

[0234] It should be noted that the steps shown in the above process or in the flowchart of the accompanying figures can be executed in a computer system such as a set of computer-executable instructions, and although a logical order is shown in the flowchart, in some cases the steps shown or described may be executed in a different order than that shown here.

[0235] This embodiment also provides an electronic device, including a memory and a processor, wherein the memory stores a computer program and the processor is configured to run the computer program to perform the steps in any of the above method embodiments.

[0236] Optionally, the electronic device may further include a transmission device and an input / output device, wherein the transmission device is connected to the processor and the input / output device is connected to the processor.

[0237] Optionally, in this embodiment, the processor can be configured to perform the following steps via a computer program:

[0238] S1, the control unit controls the signal generator to generate a stimulus signal. The energy of the stimulus signal satisfies an energy relationship, which is the accumulation of charge based on the waveform over time.

[0239] S2, the output unit outputs the stimulus signal.

[0240] It should be noted that the specific examples in this embodiment can refer to the examples described in the above embodiments and optional implementations, and will not be repeated here.

[0241] Furthermore, in conjunction with the control methods of the neurostimulators in the above embodiments, this application embodiment can provide a storage medium for implementation. The storage medium stores a computer program; when executed by a processor, the computer program implements any of the neurostimulator control methods in the above embodiments.

[0242] It should be noted that the user information (including but not limited to user device information, user personal information, etc.) and data (including but not limited to data used for analysis, data stored, data displayed, etc.) involved in this application are all information and data authorized by the user or fully authorized by all parties.

[0243] Those skilled in the art will understand that all or part of the processes in the above embodiments can be implemented by a computer program instructing related hardware. The computer program can be stored in a non-volatile computer-readable storage medium. When executed, the computer program can include the processes of the embodiments described above. Any references to memory, databases, or other media used in the embodiments provided in this application can include at least one of non-volatile and volatile memory. Non-volatile memory can include read-only memory (ROM), magnetic tape, floppy disk, flash memory, optical memory, high-density embedded non-volatile memory, resistive random access memory (ReRAM), magnetic random access memory (MRAM), ferroelectric random access memory (FRAM), phase change memory (PCM), graphene memory, etc. Volatile memory can include random access memory (RAM) or external cache memory, etc. By way of illustration and not limitation, RAM can take many forms, such as Static Random Access Memory (SRAM) or Dynamic Random Access Memory (DRAM). The databases involved in the embodiments provided in this application may include at least one type of relational database and non-relational database. Non-relational databases may include, but are not limited to, blockchain-based distributed databases. The processors involved in the embodiments provided in this application may be general-purpose processors, central processing units, graphics processing units, digital signal processors, programmable logic devices, quantum computing-based data processing logic devices, etc., and are not limited to these.

[0244] Those skilled in the art should understand that the technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments have been described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0245] The embodiments described above are merely illustrative of several implementation methods of this application, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these all fall within the protection scope of this application. Therefore, the protection scope of this patent application should be determined by the appended claims.

Claims

1. A neurostimulator, characterized in that, include: Control unit, used to control the signal generator; A signal generator is used to generate a stimulus signal whose energy satisfies an energy relationship, which is the accumulation of charge based on the waveform over time. An output unit is used to output the stimulation signal.

2. The neurostimulator according to claim 1, characterized in that, The energy relationship is PT= Where PT represents the energy within one period, This represents a waveform function, where N represents the number of waveforms within one period. This indicates the duration of each waveform within one cycle. Indicates from 0 to Points earned during this period.

3. The neurostimulator according to claim 2, characterized in that, If the waveform of the stimulus signal is a sine wave, then =E×sin(t); If the waveform is a square wave, then =±E; If the waveform is a triangular wave, then =E× Where E represents the signal strength and t represents the current time.

4. The neurostimulator according to claim 2, characterized in that, N The calculation formula is: N =Duty cycle / Frequency; The frequency ranges from 0.5 kHz to 20 kHz; and / or the duty cycle ranges from 5% to 45%.

5. The neurostimulator according to claim 1, characterized in that, The control unit is also used to determine the preset energy effective range of the stimulus signal according to the energy relationship based on the effective range or threshold of each parameter of the stimulus signal. The applied stimulation energy of the stimulation signal is controlled within the preset effective energy range.

6. The neurostimulator according to claim 5, characterized in that, The preset energy effective range of the stimulation signal includes a first boundary and a second boundary; the value of the first boundary is less than the value of the second boundary. The control unit includes: An energy accumulator is used to accumulate the energy value of the output stimulus signal to obtain the applied stimulus energy. A comparator is used to compare the applied stimulus energy with the first boundary and the second boundary; A control subunit is configured to, in response to an output from the comparator indicating that the applied stimulus energy is less than the first boundary, control the signal generator to increase the stimulus duration and / or the number of stimulus cycles; and, in response to an output from the comparator indicating that the applied stimulus energy has reached or exceeded the second boundary, control the signal generator to stop outputting the stimulus signal.

7. The neurostimulator according to claim 1, characterized in that, The control unit is also used to maintain the energy of the stimulus signal constant during the stimulation signal modulation process based on the energy relationship.

8. The neurostimulator according to claim 7, characterized in that, The signal generator is controlled to output a series of test stimulus signals, each of which has a different value for its stimulus parameter, but maintains a constant energy based on the energy relationship. The control unit is communicatively connected to a user response interface and is also used to receive physiological response signals of the target object collected by the user response interface during the output of test stimulus signals. The control unit is also used to determine the target configuration parameters from the stimulation parameters corresponding to the series of test stimulation signals according to the physiological response signals; The signal generator is also configured to generate the stimulation signal in a controlled manner according to the target configuration parameters.

9. The neurostimulator according to claim 8, characterized in that, Also includes: Storage unit, used to store the target adjustable parameter type; The target adjustable parameter type is determined by the control unit from the parameter types of the series of test stimulus signals based on the physiological response signals collected by the user response interface; The control unit is also configured to, in response to a detected adjustment trigger command, control the signal generator to adjust the corresponding stimulation signal according to the target adjustable parameter type.

10. The neurostimulator according to claim 8, characterized in that, In the series of test stimulus signals, the value of at least one stimulus parameter between adjacent signals changes monotonically, either increasing or decreasing, and the amount of change of the stimulus parameter between adjacent signals is a fixed value.

11. The neurostimulator according to claim 1, characterized in that, The control unit is further configured to control the signal generator to output a determined stimulation duration and stimulation number according to the total energy configuration parameters generated based on the energy relationship; the stimulation duration and the stimulation number satisfy the energy relationship.

12. The neurostimulator according to claim 11, characterized in that, The total energy configuration parameters are determined based on the energy relationship and the preset stimulation cycle requirement parameters.

13. The neurostimulator according to claim 11, characterized in that, The control unit includes: An energy accumulator is used to accumulate the energy value of the output stimulus signal to obtain the applied stimulus energy. A comparator is used to compare the applied stimulus energy with the total energy configuration parameter; A control subunit is configured to control the signal generator to stop outputting a stimulus signal in response to an output from the comparator indicating that the applied stimulus energy has reached the total energy configuration parameter.

14. The neurostimulator according to claim 11, characterized in that, The control unit is communicatively connected to a user input interface and receives configuration instructions sent by the user input interface that characterize the physiological condition of the target object; the configuration instructions are used to instruct the adjustment of the total energy configuration parameters.

15. The neurostimulator according to any one of claims 1 to 14, characterized in that, Also includes: A storage unit for storing reference stimulus energy generated based on reference parameter values ​​of the stimulus signal; The control unit is configured to perform an energy relationship calibration mode; In the energy relationship calibration mode, the control unit is also used to control the signal generator to adjust the reference stimulus energy to the target stimulus energy; the target stimulus energy indicates the energy reached by the stimulus signal under the energy relationship.

16. The neurostimulator according to claim 15, characterized in that, In the energy relationship calibration mode, the signal generator is controlled to output a sequence of stimulation signals whose energy values ​​increase or decrease according to a preset energy step size; The control unit is communicatively connected to a user response interface and is also used to receive physiological feedback signals from the target object collected by the user response interface during the output of the stimulus signal sequence. When the physiological feedback signal indicates that the current energy value exceeds the preset tolerance threshold, the current energy value is locked as the target stimulation energy.

17. A method for controlling a neurostimulator, characterized in that, include: The control unit controls the signal generator to generate a stimulus signal, the energy of which satisfies an energy relationship, which is the accumulation of charge based on the waveform over time; The output unit outputs the stimulation signal.

18. The control method for the neurostimulator according to claim 17, characterized in that, The control unit controls the signal generator to generate stimulation signals, including: The control unit determines the preset effective energy range of the stimulus signal based on the effective range or threshold of each parameter of the stimulus signal and in accordance with the energy relationship. The applied stimulation energy of the stimulation signal is controlled within the preset effective energy range.

19. The control method for a neurostimulator according to claim 18, characterized in that, The preset energy effective range of the stimulation signal includes a first boundary and a second boundary; the value of the first boundary is less than the value of the second boundary; the control unit includes an energy accumulator, a comparator, and a control subunit; the method further includes: The energy accumulator accumulates the energy value of the output stimulus signal to obtain the applied stimulus energy; The comparator compares the applied stimulus energy with the first boundary and the second boundary; In response to the comparator's output indicating that the applied stimulus energy is less than the first boundary, the control subunit controls the signal generator to increase the stimulus duration and / or the number of stimulations; and in response to the comparator's output indicating that the applied stimulus energy has reached or exceeded the second boundary, controls the signal generator to stop outputting the stimulus signal.

20. The control method for the neurostimulator according to claim 17, characterized in that, The control unit controls the signal generator to generate stimulation signals, including: Based on the energy relationship, the control unit maintains the energy of the stimulus signal constant during the stimulation signal modulation process.

21. The control method for a neurostimulator according to claim 20, characterized in that, The control unit maintains a constant energy level of the stimulus signal during stimulus signal modulation based on the energy relationship, including: While the signal generator outputs a series of test stimulus signals under control, each of the series of test stimulus signals has a different value for its stimulus parameter, but the energy remains constant based on the energy relationship, the control unit receives the physiological response signal of the target object collected by the user response interface during the output of the test stimulus signal; the control unit is communicatively connected to the user response interface. The control unit determines the target configuration parameters from the stimulation parameters corresponding to the series of test stimulation signals according to the physiological response signals. The signal generator is controlled to generate the stimulation signal according to the target configuration parameters.

22. The control method for the neurostimulator according to claim 17, characterized in that, The control unit controls the signal generator to generate stimulation signals, including: The control unit controls the signal generator to output a determined stimulation duration and stimulation number according to the total energy configuration parameters generated based on the energy relationship; the stimulation duration and the stimulation number satisfy the energy relationship.

23. The control method for a neurostimulator according to claim 22, characterized in that, The control unit includes an energy accumulator, a comparator, and a control subunit; the control unit controls a signal generator to generate a stimulation signal, including: The energy accumulator accumulates the energy value of the output stimulus signal to obtain the applied stimulus energy; The comparator compares the applied stimulus energy with the total energy configuration parameter; In response to the comparator's output indicating that the applied stimulus energy has reached the total energy configuration parameter, the control subunit controls the signal generator to stop outputting the stimulus signal.

24. The control method for the neurostimulator according to claim 17, characterized in that, Before the control unit controls the signal generator to generate the stimulation signal, the method further includes: The storage unit stores the reference stimulus energy generated based on the reference values ​​of the parameter reference values ​​of the stimulus signal; The control unit is configured to perform an energy relationship calibration mode; In the energy relationship calibration mode, the control unit controls the signal generator to adjust the reference stimulus energy to the target stimulus energy; the target stimulus energy indicates the energy reached by the stimulus signal under the energy relationship.

25. The control method for the neurostimulator according to claim 24, characterized in that, The control unit controls the signal generator to adjust the reference stimulus energy to the target stimulus energy, including: In the energy relationship calibration mode, the signal generator is controlled to output a sequence of stimulation signals whose energy values ​​increase or decrease according to a preset energy step size; The control unit receives physiological feedback signals from the target object collected by the user response interface during the output of the stimulation signal sequence; when the physiological feedback signal indicates that the current energy value exceeds a preset tolerance threshold, the current energy value is locked as the target stimulation energy; the control unit is communicatively connected to the user response interface.

26. A storage medium, characterized in that, The storage medium stores a computer program, wherein the computer program is configured to execute the control method of the neurostimulator according to any one of claims 17 to 25 when it is run.

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