An asymmetric biphasic burst waveform electrical stimulation control method based on parameter space configuration

Abstract

This invention discloses an asymmetric biphasic burst waveform electrical stimulation control method based on parameter space configuration, applied to electrical stimulation devices. The invention constructs a multi-dimensional parameter space, including time-domain asymmetric control parameters, pulse sequence structure parameters, envelope modulation parameters, timing interval parameters, and amplitude and polarity configuration parameters. Within each stimulation cycle, the number of positive pulses N and the number of negative pulses M satisfy N≠M and M≥2, with trough pulses providing distributed charge compensation to peak pulses and satisfying charge balance constraints. The invention also discloses the corresponding device, waveform, and system. Through multi-dimensional parameter synergistic configuration, this invention can reduce instantaneous current density, eliminate tingling sensation, inhibit sensory adaptation, adapt to different impedance sites, and improve user comfort.

Description

Technical Field

[0001] This invention relates to the field of electrical stimulation control technology, and in particular to an electrical stimulation control method that configures asymmetric biphasic burst waveforms through a multidimensional parameter space. Background Technology

[0002] Existing electrical stimulation devices typically employ fixed or limited combinations of stimulation parameters to generate a single or a small number of preset rhythmic electrical stimulation outputs. Under certain usage conditions, when this type of electrical stimulation is applied to different body parts or usage scenarios, it may suffer from insufficient consistency in stimulation experience, limited rhythmic variation, or limited parameter adaptation space. Furthermore, in some usage scenarios, due to the relatively simple configuration of stimulation parameters, neural adaptation can lead to decreased effectiveness, an inability to simultaneously provide immediate and sustained relief, and uneven charge distribution resulting in stinging.

[0003] Known polarity switching in electrical stimulation systems (such as EndoStim, 2013) primarily employs a strategy of switching every N pulses. In contrast, the polarity switching of this invention uses cumulative charge or impedance detection triggering, enabling closed-loop adaptive control.

[0004] While some existing technologies employ random pulse sequences to suppress neural adaptation, these methods often rely on complex algorithms and redundant hardware control logic. Furthermore, the randomness leads to uneven charge distribution, easily causing localized charge accumulation in low-impedance areas of the skin, resulting in a tingling sensation. Therefore, finding a simple and charge-controlled approach to address these issues is a pressing problem in this field.

[0005] Therefore, existing technologies still need to improve the parameter configuration of the stimulation waveform without increasing the complexity of the electrical stimulation device's hardware structure, in order to enhance the overall user experience and soothing effect in different usage scenarios. Summary of the Invention

[0006] The purpose of this invention is to provide a control method for an electrical stimulation device. By constructing a parameter space for an asymmetric biphasic burst waveform and selecting or adjusting parameters based on this parameter space, the method improves the neural recruitment efficiency, adaptive mechanisms, and charge control mechanisms of the electrical stimulation device when used in multiple locations and scenarios without changing the device's hardware structure. This solution employs an asymmetric biphasic burst waveform with N positive peaks and M negative troughs.

[0007] This invention provides an electrical stimulation control method that addresses the shortcomings of existing random pulse schemes, such as complex control and the tendency to cause stinging in low-impedance regions due to charge accumulation. This invention utilizes a precisely defined N / M distributed compensation structure to achieve dynamic charge balance, reduce system control complexity, and significantly improve comfort in low-impedance sensitive areas.

[0008] The core of this invention lies in constructing a multi-dimensional parameter configuration space, where the parameters satisfy the following physical constraints:

[0009] Charge balance constraint: The total positive pulse width is equal to the total negative pulse width.

[0010] Temporal distribution constraints: Introduce the ratio coefficients of trough intervals and peak intervals, as well as the ratio coefficients of rest after troughs and rest before peaks.

[0011] Edge envelope features: A slow ramp-up ratio is set for the beginning segment of the peak, and a slow ramp-down ratio is set for the end segment of the trough, in order to simulate the smooth characteristics of bioelectrical signals.

[0012] The electrical stimulation control method and device provided by this invention can be used not only for general human sensory adjustment or comfort adjustment, but also for pain-related sensory adjustment, menstrual-related discomfort adjustment and nerve stimulation scenarios.

[0013] Compared with the prior art, the present invention has at least the following beneficial effects:

[0014] — Through parameter space configuration, it helps to improve the consistency of user experience of electrical stimulation devices in different body parts or different usage scenarios; — Through multi-parameter collaborative configuration, it enhances the adjustability and variability of electrical stimulation output rhythm, thereby helping to reduce the situation of monotonous experience during long-term use; — Without increasing the complexity of the electrical stimulation device's hardware structure, it enables the configuration of multiple stimulation modes through control logic, thereby improving the device's applicability and usage flexibility.

[0015] Technical solution

[0016] To achieve the above objectives, the present invention provides the following technical solution:

[0017] An electrical stimulation control method, applied to an electrical stimulation device, comprising:

[0018] 1) Generate at least one stimulation cycle, each stimulation cycle including at least one burst waveform output stage and at least one intermittent stage; the stimulation stage described in this specification is a generalized control concept, which can correspond to any form such as time segment, output state interval, control strategy interval or mode execution interval, and is not limited to interface display or physical division.

[0019] 2) Construct an asymmetric biphase burst waveform, wherein the asymmetric biphase burst waveform includes 4 to 10 peak pulse sequences and at least 2 to 6 trough pulse sequences;

[0020] 3) Define a parameter space for describing the asymmetric two-phase burst waveform. The parameter combination can be selected from a pre-stored parameter set and / or generated or calculated by the control module based on the parameter space.

[0021] To further reveal the intrinsic relationship between various parameters in physiological regulatory functions, this invention categorizes the parameters in the parameter space into the following five functionally orthogonal parameter categories:

[0022] (a) Time-domain asymmetric control parameters

[0023] These parameters directly define the relative duration of the positive and negative phases, and are the core degrees of freedom that determine the charge balance state, current return rate, and tissue impedance adaptation.

[0024] 101 Single peak pulse width, 102 Single trough pulse width

[0025] 103 The ratio of peak to trough pulse width

[0026] 104 The ratio of trough interval to crest interval

[0027] (ii) Pulse sequence structural parameters

[0028] These parameters define the number of pulse repetitions and distribution density within a single burst window, and are used to regulate the adaptation rate of nerve fibers and prevent synchronous tetanic contractions.

[0029] 201 Number of peaks, 202 Number of troughs

[0030] 203 The time interval between peaks, 204 The time interval between troughs

[0031] (III) Envelope Modulation Parameters

[0032] These parameters define the gradual change in the leading and trailing edges of the pulse, used to suppress the tingling sensation and startle reflex caused by sudden changes in current.

[0033] 301 The ratio of the slow rise time before the peak reaches the target amplitude to the peak pulse width (leading envelope); 302 The initial amplitude of the slow rise of the peak.

[0034] 303 The ratio of the slow decline time before the amplitude of the trough reaches zero to the pulse width of the peak (back edge envelope); 304 The amplitude at the end of the slow decline of the trough.

[0035] The amplitude decrease ratio of adjacent pulses within the 305 burst cycle (inner envelope)

[0036] 306. Ratio of superimposed potential between peaks; 307. Ratio of superimposed potential between troughs

[0037] (iv) Time interval and interval ratio parameters

[0038] These parameters define the silent windows within and between pulse groups and their relative ratios, providing polarization recovery cycles for nerve fibers and adapting to different tissue impedances.

[0039] Time interval parameters: 401 Rest time before peak, 402 Rest time after trough, 403 Rest time between peak and trough.

[0040] Interval ratio parameter: The ratio of rest time after a trough to rest time before a peak.

[0041] (v) Amplitude and polarity configuration parameters

[0042] These parameters define the energy intensity and direction attributes of the stimulus output, enabling energy gradient planning and polarity switching for multi-stage stimuli.

[0043] Amplitude parameters: 501 The amplitude ratio of the first peak to the first trough; 502 The output amplitude ratio parameter between different stimulation frequencies.

[0044] Polarity parameters: 503 stimulus output polarity configuration parameters

[0045] Thus, this invention has constructed a complete multi-dimensional parameter configuration space.

[0046] The five categories of parameters mentioned above are orthogonal to each other in terms of physical meaning and physiological effects, and can be configured independently or synergistically regulated.

[0047] 4) Select or adjust at least one set of parameter combinations from the parameter space according to the target usage location, the user-selected usage mode, or the preset usage scenario;

[0048] 5) Generate the asymmetric biphasic burst waveform based on the selected parameter combination and output it to the human body to create a relaxing and soothing experience.

[0049] 3.3 Effects of the Invention

[0050] Compared with the prior art, the present invention has at least the following beneficial effects:

[0051] (a) Time-domain asymmetric control parameters

[0052] Peak pulse width:

[0053] Beneficial effects: It establishes the basic work time for a single positive energy transfer, ensuring that energy can penetrate the skin's resistance and act on the deep target area.

[0054] trough pulse width:

[0055] Beneficial effect: It provides a time window for charge reflux. By increasing the trough pulse width (e.g., 300 μs), reflux can be completed at a lower amplitude, avoiding instantaneous high-voltage stimulation.

[0056] The ratio of peak to trough pulse width:

[0057] Beneficial effects: It establishes the basis for time-domain asymmetry. By using this ratio (e.g., 1:1.5), total charge balance is achieved, DC residue is eliminated, and electrode polarization and skin electrolytic damage are prevented.

[0058] The ratio of trough intervals to crest intervals:

[0059] Beneficial effects: Achieves a coordinated rhythm between energy output and return. This proportional linkage simulates the natural fluctuations of bioelectricity, enhancing the rhythmic feel of the massage.

[0060] (ii) Pulse sequence structural parameters

[0061] Number of peaks:

[0062] Beneficial effects: Enhances the time summation effect of neural recruitment, serves as a carrier for the inner envelope diminishing algorithm, solves the problem of neural tolerance, and regulates the "quality" and "explosiveness" of stimuli.

[0063] Number of troughs:

[0064] Beneficial effect: By using fewer troughs than peaks, the instantaneous amplitude of the negative compensation current can be reduced by utilizing wide-time-domain troughs, thereby improving the relief effect while reducing the "negative needle prick" (fluid return).

[0065] Time interval between peaks:

[0066] Beneficial effects: It controls the instantaneous frequency of positive energy output, and by adjusting the interval, it can change the "force" of the massage and prevent muscles from contracting involuntarily.

[0067] The time interval between troughs:

[0068] Beneficial effects: Controlling the rhythm of distributed reflux and dispersing reflux energy evenly along the time axis further reduces the instantaneous discharge intensity at the skin interface.

[0069] (III) Envelope Modulation Parameters

[0070] The ratio of the slow rise time before the peak reaches the target amplitude to the peak pulse width (leading envelope):

[0071] Beneficial effects: Introducing waveform leading-edge buffering prevents the impact force caused by sudden current changes, allowing the massage sensation to gradually increase and making the body feel gentler.

[0072] The initial amplitude of the slowly rising peak:

[0073] Beneficial effects: It sets a baseline for energy output, eliminates the lag from starting from zero, and avoids muscle spasms caused by excessively high initial energy.

[0074] The ratio of the slow decline time before the trough amplitude reaches zero to the peak pulse width (back edge envelope):

[0075] Beneficial effects: Introducing waveform trailing edge buffering. This ensures a smooth end to the charge return process, reduces minor fluctuations caused by voltage drops, and improves the smoothness of the device's output.

[0076] Amplitude at the end of a slow decline in the trough:

[0077] Beneficial effects: Controlling the residual voltage drop during the turn-off phase ensures thorough charge return, further solidifying the technical effect of "zero DC residue" from a physical perspective.

[0078] The percentage decrease in amplitude between adjacent peak pulses within the burst cycle (inner envelope):

[0079] Beneficial effects: Compared with medium-amplitude burst pulses in existing technologies, it can inhibit neural adaptation, prolong the effective treatment window, alleviate instantaneous sensory impact, improve the subtlety of bodily sensation, balance dynamic charge, and reduce the risk of local tissue polarization.

[0080] Ratio of superimposed potential between wave peaks:

[0081] Beneficial effects: Achieves "stepped depolarization", improves the efficiency of deep pain relief, enhances the "continuity" of stimulation, and reduces instantaneous stinging.

[0082] Ratio of superimposed potential between troughs:

[0083] Beneficial effects: Constructs a "charge recovery buffer zone," protects high-resistivity skin, inhibits neural adaptation, and prolongs the effective treatment window. Timing interval and proportional parameters.

[0084] Rest time before peak:

[0085] Beneficial effects: Setting a "quiet period" before the start of each pulse group allows nerve fibers time to recover from polarization, thus improving the sensitivity of the next pulse input.

[0086] Rest period after the trough:

[0087] Beneficial effects: Ensures that the residual weak charge after reflow has sufficient time to dissipate, guarantees the physical safety of the equipment output, and reduces the burning sensation during long-term use.

[0088] Rest time between peaks and troughs:

[0089] Beneficial effects: Provides a discharge buffer period for skin capacitance, avoids induced current spikes caused by rapid alternation of positive and negative phases, and improves the smoothness of the feel.

[0090] The ratio of rest time after a trough to rest time before a peak:

[0091] Beneficial effects: By adjusting this ratio (e.g., 1.5 times), the envelope morphology of the pulse group can be changed, thereby affecting the thickness and impedance of muscle / tissue groups in different parts of the human body.

[0092] (v) Amplitude and polarity configuration parameters

[0093] The amplitude ratio of the first peak to the first trough:

[0094] Beneficial effects: Under the premise of charge conservation, the depth of the return electric field can be flexibly adjusted. A lower trough amplitude can make the return process gentler and eliminate the "needle-pricking sensation".

[0095] Output amplitude ratio parameter between different stimulus frequencies:

[0096] Beneficial effects: By dividing the burst waveform into different stimulation stages with energy gradients, the penetration rate can be adjusted for different tissue depths. For example, a smaller proportion can prevent nerve tolerance in sensitive areas (such as around the ear), while a larger proportion can ensure effective activation of deep muscles in high-resistance areas (such as the lower back and abdomen).

[0097] Stimulus output polarity configuration parameters:

[0098] Beneficial effects: The polarity operator and pulse width scaling factor work synergistically to form the core charge balance mechanism of this invention. Active depolarization: It achieves active neutralization of accumulated charge at the tissue interface, completely solving the electrochemical polarization problem caused by traditional unidirectional pulses; and improves the smoothness of the skin.

[0099] The aforementioned 22 parameters, through multidimensional coupling mapping, collectively construct an energy management space capable of dynamically adjusting according to skin contact impedance. Its beneficial effects lie not only in achieving physical charge balance, but also in completely resolving the issues of tingling sensation and electrode polarization inherent in traditional single-wavelength solutions during high-intensity output by controlling the microscopic details of the pulse envelope. Attached Figure Description

[0100] Figure 1 This is a waveform diagram of existing technology;

[0101] Figure 2 Define the diagram for microscopic parameters;

[0102] Figure 3 This is a macroscopic time series structure diagram;

[0103] Figure 4 For control flowchart;

[0104] Figure 5 This is a block diagram of the device structure;

[0105] Figure 6 This is a graph showing the frequency-output amplitude ratio. Detailed Implementation

[0106] In practice, the electrical stimulation waveform described in this invention can be configured with parameters according to different application scenarios.

[0107] For example, during use on different parts of the human body, it can be used to achieve sensory modulation, comfort modulation, or stimulus response modulation; in specific application scenarios, it can also be used for pain-related sensory modulation, menstrual-related discomfort modulation, and other nerve stimulation scenarios.

[0108] The embodiments and parameter configurations described in this invention are intended to enhance the user's skin feel and muscle relaxation experience during use by precisely controlling the physical characteristics of electrical pulses. Terms such as 'relief' and 'sensory stimulation' in the related descriptions refer to the enhancement of physiological sensory comfort, rather than clinical treatment recommendations for specific diseases.

[0109] Example 1: Parameter combination example of shoulder relaxation electrical stimulation

[0110] In shoulder applications, a shorter peak pulse width and a relatively large ratio between the amplitudes of the first peak and the first trough are selected, along with a longer rest time after the trough, to enhance rhythmic variation and improve the relaxation experience. The above parameter combination is merely an example; the invention is not limited to this combination, and each parameter in the parameter space can be adjusted individually or in combination according to different usage scenarios.

[0111] Example 2: Parameter combination example of knee relaxation electrical stimulation

[0112] In knee applications, a longer peak pulse width and a smaller peak interval are selected, along with an increased proportion of slow peak rise time, to provide a stable electrical stimulation rhythm while maintaining comfort. The above parameter combination is merely an example; the invention is not limited to this combination, and each parameter in the parameter space can be adjusted individually or in combination according to different application scenarios.

[0113] Example 3: Parameter combination example of elbow relaxation electrical stimulation

[0114] By adjusting the ratio of peak to trough pulse widths and increasing the rest time before the peak, the design adapts to the localized sensitivity to rhythm changes. The above parameter combinations are merely examples; the invention is not limited to these combinations, and each parameter in the parameter space can be adjusted individually or in combination according to different application scenarios.

[0115] Example 4: Parameter combination example of electrical stimulation for waist and abdomen relaxation

[0116] By increasing the proportion of the slow descent time of the trough and reducing the amplitude at the end of the trough, the abruptness of the stimulation termination is reduced, thus enhancing the overall relaxation experience. The above parameter combination is merely an example; the invention is not limited to this parameter combination, and each parameter in the parameter space can be adjusted individually or in combination according to different usage scenarios.

[0117] Example 5: Example of electrical stimulation parameter combinations for the neck or submandibular region (corresponding to the pharyngeal muscle group)

[0118] By shortening the peak pulse width and significantly increasing the ratio of rest time after the trough to rest time before the peak, this parameter combination can induce sustained, gentle contraction tension in superficial muscles, preventing muscle relaxation and collapse. It also avoids waking the user due to excessive electrical stimulation, making it suitable for muscle care scenarios involving prolonged overnight wear. The above parameter combination is merely an example; the invention is not limited to this combination, and each parameter in the parameter space can be adjusted individually or in combination according to different usage scenarios.

[0119] Example 6: Example of weak current soothing mode electrical stimulation parameter combination in the concha and periauricular sensitive areas

[0120] By shortening the peak pulse width and setting the trough pulse width to a specific multiple of the peak pulse width, charge balance is achieved through time-domain stretching. Increasing the "proportion of slow peak rise time" and setting the initial rise amplitude to a specific proportion of the target amplitude allows energy to enter at an extremely gentle slope. Increasing the "ratio of rest time after trough to rest time before peak" to a specific multiple provides sufficient polarization recovery cycles for local nerves. This achieves extremely delicate, needle-free microcurrent coverage in the concha region, generating a pulse envelope that mimics natural biological fluctuations, effectively relieving muscle tension and nerve compression in sensitive areas, and achieving rhythmic relaxation without triggering pain warnings. The above parameter combination is merely an example; the invention is not limited to this parameter combination, and each parameter in the parameter space can be adjusted individually or in combination according to different usage scenarios.

[0121] Example 7: Example of combinations of peak and trough numbers

[0122] This embodiment is achieved by calling a specific combination of parameters in the parameter space.

[0123] This embodiment employs a precisely defined N / M distributed compensation structure, rather than the random pulse scheme used in existing technologies. Compared to the random scheme, the distributed structure of this invention improves charge balance and reduces tingling sensation.

[0124] Figure 2 shows the arrangement of the 6 peaks and 4 troughs in this embodiment and the waveform envelope after charge balance.

[0125] The specific spatiotemporal arrangement logic is as follows:

[0126] Within each burst cycle, six high-amplitude, 200-microsecond positive peak pulses are arranged consecutively at preset peak intervals, forming the main stimulation pulse group; this is followed by four low-amplitude, 300-microsecond negative trough pulses, forming the charge balance pulse group. Since N>M and the duration of each trough (trough pulse width) is configured to be 1.5 times the peak pulse width, the instantaneous current intensity of a single trough is significantly diluted.

[0127] This embodiment uses a specific combination of '6 peaks and 4 valleys', which has the following significant beneficial effects:

[0128] Balancing energy accumulation and sensory refinement: The explosive input of 6 peaks ensures the 'time summation effect' generated by nerve fibers, enabling it to penetrate the high-resistance layer of the skin and relieve deep pain; while the compensation charge is shared by 4 troughs, avoiding the 'sensory dragging sensation' that may be caused by excessively long single trough pulses, making the sensory neutralization process more uniform.

[0129] Optimized charge recovery distribution: Compared to the symmetrical 6 peaks and 6 valleys, this design reduces the number of valleys and extends the duration, thereby lowering the peak current of the negative wave and eliminating the stinging sensation. Compared to 6 peaks and 1 valley, the configuration of 4 valleys increases the frequency of charge neutralization (i.e., a denser neutralization rhythm), making the sensation during the energy recovery phase softer and more delicate, similar to a micro-vibration massage, thus improving the comfort of long-term wear.

[0130] Inhibition of neural adaptation: The 6:4 asymmetric ratio, combined with the decreasing peak amplitude envelope in this embodiment, creates a complex micro-rhythm, effectively preventing the nervous system from developing 'tolerance' to a single stimulation frequency, thereby extending the effective window of physical therapy. The moderate decrease in peak amplitude by a total of 20%-40% simulates the natural convergence of biological signals, effectively avoiding the rapid decline in neural sensitivity caused by constant high-frequency stimulation. Experiments show that within this ratio range, the user experiences the smallest decrease in stimulation perception after 20 minutes of continuous use.

[0131] In other alternative embodiments, N and M can also be flexibly adjusted within the above range according to the impedance of different human body parts.

[0132] Example 8: A step-by-step relief plan for specific physical discomforts during a woman's menstrual period.

[0133] See also: Figure 3 Macroscopic time series structure diagram

[0134] This embodiment uses the waveform structure of Embodiment 7.

[0135] This embodiment demonstrates an adaptive parameter configuration program with a total duration of 30 minutes. The scheme aims to combine tactile relaxation with local tissue circulation drive through four stages of frequency transformation and micro-waveform superposition rate control.

[0136] Phase 1: High-frequency, high-intensity perception phase (4 minutes)

[0137] Technical logic: By maintaining a high superposition rate of around 30%, a strong "time summation effect" is generated, which improves neural recruitment efficiency and makes the stimulus signal form a continuous sense of coverage at the brain's perception level, thereby interfering with local negative somatosensory signals.

[0138] Phase Two: Low-Frequency Pulse Drive Phase (4 minutes)

[0139] Technical Logic: By reducing the superposition rate to below 10%, sufficient space for tissue repolarization is provided, inducing regular contraction and relaxation in deep muscles. A high amplitude ratio of 280% is used to achieve deep energy penetration, effectively relieving the localized heaviness caused by muscle tension.

[0140] Phase 3: Mid-frequency somatosensory transition period (4 minutes)

[0141] Technical logic: As a smooth transition period in the later stages of the program, by simulating the natural fluctuation characteristics of bioelectricity, the tissue's familiarity with a single rhythmic signal is reduced (anti-adaptation), thus maintaining a continuous skin recruitment effect.

[0142] Phase 4: System Reset and Polarity Switching (3 minutes)

[0143] Technical Logic: The control module performs a physical polarity reversal. This step aims to eliminate polarization drift under long-term unidirectional charge output at a physical level, ensuring the electrochemical stability of the electrode-skin contact surface.

[0144] Technical effects and patent advantages

[0145] Macroscopic charge balance: In addition to the asymmetric biphase balance within a single pulse cycle, the polarity reversal of a 15-minute large cycle achieves "net zero charge accumulation" in the macroscopic dimension, completely eliminating the polarization risk under long-term use of high-impedance electrodes.

[0146] Breaking neural adaptation: Polarity reversal changes the direction of ion movement between tissue interfaces. Combined with the inner envelope reduction algorithm, it can significantly prolong the sensitive period of the nervous system to stimulation, ensuring that the second 15-minute cycle still has extremely high recruitment efficiency.

[0147] Enhanced adaptability: This scheme utilizes the polarity configuration parameter (22) in the parameter space and the timing interval parameter (16~18) to work together, enabling the device to achieve safety assurance through software timing without adding additional hardware.

[0148] The parameter combinations in the above embodiments are merely examples. This invention is not limited to these parameter combinations. Each parameter in the parameter space can be adjusted individually or in combination according to different usage scenarios.

[0149] Tissue adaptive regulation of pulse width ratio parameter

[0150] Based on the common extraction features of multiple embodiments of the present invention, the ratio of the peak pulse width to the trough pulse width exhibits a clear correlation with the tissue impedance characteristics of the target body part. This ratio parameter is configured as an adaptive adjustment benchmark for different tissue impedances:

[0151] (a) Low impedance sensitive region

[0152] For low-impedance sensitive areas with thin stratum corneum and dense nerve endings (including but not limited to the neck, jaw, concha, and elbow), where skin impedance is low and instantaneous current density easily exceeds the pain threshold, this invention provides a gradient adaptation scheme from mild to extremely mild. The proportional parameter is configured within the range of 1:1.5 to 1:3.0, wherein:

[0153] A ratio of 1:1.5 to 1:2.0 is suitable for relatively tolerant areas in low-impedance regions (such as the elbow).

[0154] A ratio of 1:2.0 to 1:2.5 is suitable for areas with moderate sensitivity or significant individual differences.

[0155] A ratio of 1:2.5 to 1:3.0 is suitable for highly sensitive areas (such as the neck and concha), which suppress the instantaneous current density below the pain threshold by significantly stretching the return time window.

[0156] (ii) Medium to high impedance deep muscle region

[0157] For areas with thicker stratum corneum and deeper muscle tissue exhibiting medium to high impedance (including but not limited to the shoulders, knees, and lower abdomen), these areas require sufficient energy penetration depth to achieve effective stimulation. This invention configures the ratio parameter within the range of 1:1.0 to 1:1.8 to achieve a gradient adaptation from high penetration to moderate buffering.

[0158] A ratio of 1:1.0 to 1:1.3 is suitable for scenarios with extremely high impedance or requiring deep and strong stimulation (such as the knee, deep abdominal and lumbar regions), maximizing the efficiency of positive energy injection.

[0159] A ratio of 1:1.3 to 1:1.6 is suitable for routine deep muscle relaxation (such as the shoulders and superficial areas of the waist and abdomen), achieving a balance between effective stimulation and comfortable sensation under the constraint of charge balance.

[0160] A ratio of 1:1.6 to 1:1.8 is suitable for sensitive areas in the medium to high impedance region (such as the junction of the neck and shoulder), providing additional backflow buffer while maintaining effective stimulation.

[0161] It is worth noting that the aforementioned ratio ranges partially overlap across different tissue regions (for example, 1:1.5 to 1:1.8 is applicable to both low-impedance, high-impedance, and sensitive regions). This overlap is not a technical contradiction, but rather reflects the multidimensional adaptability of the ratio parameters in this invention—the same ratio value can achieve different emphases of technical effect depending on different baseline impedance levels: in low-impedance scenarios, it emphasizes suppressing current surges, while in high-impedance scenarios, it emphasizes maintaining effective penetration. This further demonstrates the flexibility and adaptive control capability of the parameter space in this invention.

[0162] The above numerical ranges are common extractions based on multiple embodiments of the present invention, constituting an adaptive adjustment benchmark for the proportional parameters for different tissue impedances. Those skilled in the art should understand that, without exceeding the core concept of the present invention, the above ranges can be selected or fine-tuned according to specific application scenarios.

[0163] Device Example:

[0164] Example 1: The parameter space generation module can be implemented using digital circuits, analog circuits, firmware, or software, or any combination of the above methods.

[0165] Example 2: The control module can implement parameter configuration and stage strategy control through local control, external device control, wireless communication control or software control.

[0166] Example 3: The control module, parameter space generation module and pulse output module can be implemented by independent hardware units, or by the same processing unit in software or firmware.

[0167] Example 4: In one embodiment, at least one set of optimized parameters in the parameter space is pre-fixed in the storage unit of the electrical stimulation device, so that the device can directly call the specific parameters to generate an asymmetric biphasic burst waveform after startup.

[0168] Summary of the technical solution of this invention

[0169] In summary, this invention achieves precise full-dimensional control of electrical stimulation energy output in the time domain, value domain, and envelope morphology by constructing an asymmetric biphasic burst waveform parameter space containing 22 micro-control indicators.

[0170] in conclusion

[0171] This invention is not only a method for generating electrical stimulation signals, but also a complete human tissue impedance matching engine. Through the coordinated control of multi-dimensional parameters, it successfully breaks the impossible triangle between "safety," "energy intensity," and "relief effect" in traditional electrical stimulation devices, providing key technical support for the evolution of electrical stimulation devices towards high precision and full-scenario adaptability.

Claims

1. An electrical stimulation control method applied to an electrical stimulation device, characterized by, include: 1) Generate a set of asymmetric biphasic burst waveforms within each stimulation cycle, the waveforms including: N positive peak pulses; M negative trough pulses; in: N and M are positive integers and satisfy N > M; The trough pulse is used to perform distributed compensation for the charge generated by the peak pulse, rather than single centralized compensation. 2) Apply the following time-domain and amplitude coupling constraints to the waveform: The total charge of the trough pulse and the total charge of the peak pulse satisfy charge balance within one stimulation cycle or a preset time window. The duration of a single trough pulse is greater than or equal to 1.2–3.0 times the duration of a single crest pulse; The amplitude of the trough pulse is 50%–90% of the amplitude of the peak pulse; 3) Apply a non-uniform micro-modulation structure within the N peak pulses, including at least one of the following: The peak pulse amplitude decreases or increases monotonically according to a preset ratio; The time interval between adjacent peak pulses is non-uniformly distributed; The peak pulse amplitude and time interval change simultaneously; To form non-periodic stimulation patterns that can alter the characteristics of human sensory responses; 4) A non-zero transition level interval is set between at least one peak pulse and its adjacent trough pulse, wherein the interval satisfies: The current does not return to zero directly; The level changes in a stepped or continuous manner; To reduce the instantaneous stimulation caused by sudden changes in current; 5) Perform dynamic polarity switching control between different stages of the stimulation process, wherein: The switching is based on at least one of the following triggering conditions: Cumulative output charge; Load impedance variation; The switching is achieved by reversing the polarity of the entire output waveform; And maintain the N > M asymmetric structural relationship after polarity switching; 6) Based on the electrical impedance characteristics of the target human body part, select or adjust the following parameter combinations: Peak / trough pulse width ratio; Ratio of peaks to troughs (N / M); The ratio of crest interval to trough interval; This allows the waveform to be adapted to the stimulation requirements of different impedance regions.

2. An asymmetric biphasic burst waveform for electrical stimulation, characterized in that: One stimulation cycle includes: Multiple positive peak pulses; Multiple negative trough pulses; in: 1) The number of peak pulses is N, and the number of trough pulses is M, and the following conditions are met: N > M ≥ 2 2) The trough pulse is used to perform multiple distributed backflow compensations for the charge generated by the peak pulse, and: The pulse width of each trough pulse is greater than the pulse width of the corresponding peak pulse; The amplitude of each trough pulse is lower than the amplitude of the peak pulse; 3) An inner envelope structure is formed in the wave crest pulse sequence, characterized in that: The peak amplitude varies by a total decrease of 10%–50% within the stimulation cycle; 4) The waveform has a non-zero level transition region between the peaks and troughs, forming a continuous or stepped current change; 5) The waveform as a whole satisfies the charge balance constraint within one or more cycles.

3. An electrical stimulation device, comprising: The parameter space generation module is used to generate and store parameter space data; The control module, connected to the parameter space generation, is configured to read the parameter space data and generate control commands; The pulse output module, in response to the control command, generates and outputs the asymmetric biphasic burst waveform as described in claims 1 and 2. The device further includes: External control devices can generate corresponding parameter spaces based on user feedback and then transmit them to the parameter space generation module. The detection module is used to detect the load impedance and provide feedback to the parameter space generation module for parameter adjustment.

4. An electrical stimulation method for modulating human sensory responses, characterized in that: Within one burst waveform period, the peak pulse is modulated by at least two of the following combinations: Amplitude-decreasing modulation; Non-uniform time interval modulation; Non-zero transition modulation between peaks and troughs; This causes the stimulus signal to change non-periodically in the microscopic time domain, thereby altering the human body's sensory response characteristics to repetitive stimuli.

5. The method or waveform of claim 1 or 2, wherein: The value of N is 4 to 10, and the value of M is 2 to 6.

6. The method or waveform of claim 5, wherein: The preferred values ​​are N=6 and M=4.

7. The method of claim 1, wherein: For the low impedance region, the peak / trough pulse width ratio is 1:1.5 to 3.

0.

8. The method of claim 1, wherein: For the medium-to-high impedance region, the peak / trough pulse width ratio is 1:1.0 to 1.

8.

9. The method of claim 1, wherein, When the target body part is a low-impedance sensitive area: - When the output frequency is ≥50Hz (high frequency), the output amplitude ratio parameter is 100%; - When the output frequency is greater than 0Hz to 10Hz, the output amplitude ratio parameter is 150%-200% of that at high frequencies; - When the output frequency is greater than 10Hz to less than 50Hz, the output amplitude ratio parameter is 100%-150% of that at high frequencies.

10. The method of claim 1, wherein, When the target body part belongs to the medium-to-high impedance region: - When the output frequency is ≥50Hz (high frequency), the output amplitude ratio parameter is 100%; - When the output frequency is greater than 0Hz to 10Hz, the output amplitude ratio parameter is 200%-300% of that at high frequencies; - When the output frequency is greater than 10Hz to less than 50Hz, the output amplitude ratio parameter is 150%-200% of that at high frequencies.

11. The method of claim 1, wherein: The change in polarity configuration is performed periodically every 3-15 minutes.

12. The method according to claim 1, wherein there is a superimposed potential between the trough pulses.

13. The method according to claim 1, wherein there is a superimposed potential between the wave peak pulses.

14. The apparatus of claim 2, wherein: The device is a wearable electrical stimulation device, specifically at least one of the following: ear-hook, neck-hook, waist-belt, knee-band, or patch type.

15. The apparatus of claim 2, wherein: The storage module contains at least one set of optimal combinations of parameters for specific body parts.

16. The apparatus according to claim 2, characterized in that: The control module supports local control, external device control, or wireless network control.

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