Method and apparatus for adjusting electrical stimulation intensity, electrical stimulation device

Abstract

The application discloses an electric stimulation intensity adjusting method and device and an electric stimulation device. The electric stimulation intensity adjusting method is applied to a controller used for controlling a stimulator to apply electric stimulation. In the process of applying electric stimulation, an electric stimulation pulse sequence comprises a pulse intensity rising stage and a pulse intensity maintaining stage. The electric stimulation intensity adjusting method comprises the following steps: acquiring a gear-up signal and recording a signal acquisition time; when the signal acquisition time is located in the pulse intensity maintaining stage, judging whether a time interval between the signal acquisition time and a cutoff time of the pulse intensity maintaining stage is greater than a preset time interval; wherein the preset time interval is determined according to the gear-up signal; and if yes, performing electric stimulation intensity gear position promotion according to the gear-up signal. The embodiment of the application can reduce the risk that the electric stimulation intensity gear-up adjustment exceeds the tolerance of a patient, and improve the safety of the gear-up adjustment.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a method and apparatus for adjusting the intensity of electrical stimulation, and an electrical stimulation device. Background Technology

[0002] Currently, electrostimulation devices in the medical field utilize biofeedback and neuro-electrical stimulation as physical therapies for rehabilitation. Taking pelvic floor muscle rehabilitation devices as an example, the treatment process involves inserting a vaginal electrode into the vagina. The patient must then perform voluntary vaginal contractions and relaxations according to the instructions on the display interface to strengthen the pelvic floor muscles. During this process, the electrode pads on the vaginal electrode deliver electrical stimulation to the vaginal wall to ensure the therapeutic effect. During electrostimulation therapy, the patient can adjust the intensity of the stimulation based on their subjective feelings. That is, if the perceived intensity is too high, the intensity level can be lowered; conversely, if the perceived intensity is too low, the intensity level can be increased.

[0003] The application of electrical stimulation by an electrical stimulation device typically involves multiple sequences of electrical stimulation pulses. These sequences may include a pulse intensity rise phase, a pulse intensity hold phase, a pulse intensity fall phase, and a rest period. The next sequence begins after the previous one is completed, and any intensity adjustment made in the previous sequence is carried over to the next. Improper timing of intensity increase adjustments may result in the pulse intensity hold phase exceeding the patient's tolerance. For example, if the increase occurs during the rise phase of the current pulse sequence, the hold phase intensity may exceed the patient's tolerance. Similarly, if the increase occurs during the fall phase, the hold phase intensity may exceed the patient's tolerance. Current technologies often neglect the timing of intensity increase adjustments, making it difficult to ensure their safety. Summary of the Invention

[0004] This invention provides a method and apparatus for adjusting electrical stimulation intensity, as well as an electrical stimulation device, to reduce the risk of adjusting the electrical stimulation intensity beyond the patient's tolerance and to improve the safety of adjusting the intensity.

[0005] In a first aspect, embodiments of the present invention provide an electrical stimulation intensity adjustment method applied to a controller, the controller being used to control a stimulator to apply electrical stimulation; during the application of electrical stimulation, the electrical stimulation pulse sequence includes a pulse intensity rising phase and a pulse intensity holding phase;

[0006] The method for adjusting the intensity of electrical stimulation includes:

[0007] Acquire the upshift signal and record the moment the signal is acquired;

[0008] When the signal acquisition time is within the pulse intensity holding phase, it is determined whether the time interval between the signal acquisition time and the end time of the pulse intensity holding phase is greater than a preset time interval; wherein, the preset time interval is determined according to the upshift signal;

[0009] If so, the intensity of the electrical stimulation is increased according to the aforementioned upgrade signal.

[0010] Optionally, determining whether the time interval between the signal acquisition time and the pulse intensity hold phase end time is greater than a preset time interval includes:

[0011] Based on the upshift signal, the pulse intensity holding phase is sequentially divided into an allowable adjustment sub-phase and an inactive adjustment sub-phase; wherein, the duration of the inactive adjustment sub-phase is greater than or equal to the preset time interval;

[0012] Determine whether the signal acquisition time is within the allowed adjustment sub-stage;

[0013] If so, the intensity of the electrical stimulation is increased according to the aforementioned upgrade signal.

[0014] Optionally, the preset time interval can be obtained in the following ways:

[0015] Determine the target gear based on the upshift signal and the current gear;

[0016] The preset time interval is determined based on the adjustment time required to shift from the current gear to the target gear, and the information interaction time between the controller and the stimulator.

[0017] Optionally, the method for adjusting the intensity of electrical stimulation further includes: acquiring at least one additional signal during the process of increasing the intensity level of electrical stimulation, or after the increase in the intensity level of electrical stimulation is completed;

[0018] After each upshift signal is acquired, the number of remaining gears to be adjusted between the target gear corresponding to this upshift signal and the current gear is determined; and the time interval between the acquisition time of this upshift signal and the cutoff time of the pulse intensity holding phase is determined to meet the gear adjustment time requirements of all remaining gears to be adjusted.

[0019] If so, the target level corresponding to this upgrade signal will be used as the target adjustment level to increase the electrical stimulation intensity in multiple levels.

[0020] If not, then the target level corresponding to the previous upgrade signal is used as the target adjustment level, and the electrical stimulation intensity is increased in multiple levels.

[0021] Optionally, the upshift signal is a multi-level upshift signal;

[0022] The intensity level of electrical stimulation is increased according to the aforementioned upgrade signal, including:

[0023] The electrical stimulation intensity is gradually increased from the current level until the level is raised to the target level corresponding to the multi-level boost signal; wherein, the preset time interval includes the boost time from the current level to the target level.

[0024] Optionally, the electrical stimulation intensity adjustment method further includes:

[0025] Receive a pause upshift signal;

[0026] The increase in electrical stimulation intensity level is stopped according to the pause signal, and the current level is maintained for electrical stimulation.

[0027] Optionally, the adjustment time is the same for each gear.

[0028] Alternatively, as the number of gears increases, the adjustment time for each gear decreases progressively.

[0029] Optionally, the electrical stimulation intensity adjustment amount is the same for each gear level;

[0030] Alternatively, as the number of gears increases, the intensity of electrical stimulation corresponding to each gear decreases progressively.

[0031] Alternatively, as the number of gears increases, the intensity of electrical stimulation corresponding to each gear level increases progressively.

[0032] Secondly, embodiments of the present invention also provide an electrical stimulation intensity adjustment device, comprising:

[0033] The signal acquisition module is used to acquire upshift signals and record the moment of signal acquisition.

[0034] The duration determination module is used to determine whether the time interval between the signal acquisition time and the end time of the pulse intensity holding phase is greater than a preset time interval when the signal acquisition time is in the pulse intensity holding phase; wherein, the preset time interval is determined according to the upshift signal;

[0035] The intensity adjustment module is used to increase the intensity level of electrical stimulation according to the up-level signal when the time interval between the signal acquisition time and the cutoff time of the pulse intensity holding phase is greater than a preset time interval.

[0036] Thirdly, embodiments of the present invention also provide an electrical stimulation device, including: a stimulator, a controller, and a memory;

[0037] Both the stimulator and the memory are communicatively connected to the controller.

[0038] The memory stores a computer program that can be executed by the controller, and the computer program is executed by the controller to enable the controller to perform the electrical stimulation intensity adjustment method provided in any embodiment of the present invention.

[0039] In the electrical stimulation intensity adjustment method provided by this invention, the intensity increase is performed during the pulse intensity maintenance phase. This ensures that the intensity increase is based on the maximum intensity of the current electrical stimulation pulse sequence, avoiding increases during pulse intensity changes that could cause the electrical stimulation intensity in the subsequent pulse intensity maintenance phase to exceed the patient's tolerance, thus guaranteeing the safety of the electrical stimulation intensity adjustment. Furthermore, this invention performs the intensity increase adjustment when the time interval between the signal acquisition time and the end time of the pulse intensity maintenance phase is greater than a preset time interval. This ensures that intensity adjustment based on the intensity increase signal can be completed during the pulse intensity maintenance phase, while avoiding the impact of the intensity increase operation on the duration of the current pulse intensity maintenance phase, and consequently, avoiding any impact on the timing of subsequent treatment processes. Therefore, compared to existing technologies, this invention reduces the risk of the electrical stimulation intensity increase exceeding the patient's tolerance, improving the safety of intensity increase adjustment.

[0040] It should be understood that the description in this section is not intended to identify key or essential features of the embodiments of the present invention, nor is it intended to limit the scope of the invention. Other features of the invention will become readily apparent from the following description. Attached Figure Description

[0041] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0042] Figure 1 This is a schematic diagram of the treatment process of an electrical stimulation device provided in an embodiment of the present invention;

[0043] Figure 2 This is a pulse diagram illustrating the treatment process of an electrical stimulation device provided in an embodiment of the present invention;

[0044] Figure 3 This is a schematic diagram of an electrical stimulation pulse sequence provided in an embodiment of the present invention;

[0045] Figure 4This is a schematic flowchart of an electrical stimulation intensity adjustment method provided in an embodiment of the present invention;

[0046] Figure 5 This is a schematic flowchart of another method for adjusting the intensity of electrical stimulation provided in an embodiment of the present invention;

[0047] Figure 6 This is a schematic diagram of a method for increasing the intensity level of electrical stimulation provided in an embodiment of the present invention;

[0048] Figure 7 This is a schematic diagram of another method for increasing the intensity level of electrical stimulation provided in an embodiment of the present invention;

[0049] Figure 8 This is a schematic diagram of the structure of an electrical stimulation intensity adjustment device provided in an embodiment of the present invention;

[0050] Figure 9 This is a schematic diagram of the structure of an electrical stimulation device provided in an embodiment of the present invention. Detailed Implementation

[0051] To enable those skilled in the art to better understand the present invention, the technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort should fall within the scope of protection of the present invention.

[0052] It should be noted that the terms "first," "second," etc., in the specification, claims, and accompanying drawings of this invention are used to distinguish similar objects and are not necessarily used to describe a specific order or sequence. It should be understood that such data can be interchanged where appropriate so that the embodiments of the invention described herein can be implemented in orders other than those illustrated or described herein. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion.

[0053] This invention provides a method for adjusting the intensity of electrical stimulation, applicable to applications requiring increased intensity from electrical stimulation devices. By allowing sufficient time for the intensity increase during the pulse intensity holding phase, the method ensures the increase is completed before the pulse intensity holding phase ends, guaranteeing the safety of the increase operation. This method can be executed by an electrical stimulation intensity adjustment device, which can be implemented in hardware and / or software and can be configured within the electrical stimulation device.

[0054] To better explain the electrical stimulation intensity adjustment method provided in this embodiment, the treatment process of the electrical stimulation device will be described first.

[0055] Figure 1 This is a schematic diagram of the treatment process of an electrical stimulation device provided in an embodiment of the present invention. Figure 2 This is a pulse diagram illustrating the treatment process of an electrical stimulation device provided in an embodiment of the present invention. (Combined with...) Figure 1 and Figure 2 For example, the treatment process of the electrical stimulation device can consist of multiple treatment stages, each of which may include one or more electrical stimulation pulse sequences, each of which may be composed of a basic electrical stimulation waveform (pulse). The number of electrical stimulation pulse sequences in each treatment stage may be the same or different, and the pulse intensity, frequency, number, period, and duty cycle of each electrical stimulation pulse sequence may also be the same or different, and can be set according to actual needs.

[0056] For details on the specific composition of the electrical stimulation pulse sequence, please refer to [link / reference]. Figure 3 For example, an electrical stimulation pulse sequence may include a pulse stimulation period T1 and a rest period T2. Based on the changing trend of the pulse intensity envelope or the changing pattern of each pulse amplitude, the pulse stimulation period T1 may include a pulse intensity rising phase T11, a pulse intensity holding phase T12, and a pulse intensity falling phase T13 arranged sequentially in time. During treatment, at least the duration of the pulse intensity rising phase T11 of the first electrical stimulation pulse sequence is not zero. The patient's tolerance to electrical stimulation is established by gradually increasing the electrical stimulation pulse intensity (e.g., current magnitude), and the patient's tolerance to the initial intensity level at the start of treatment is determined, ensuring the safety of the treatment process. If the electrical stimulation intensity remains within the patient's tolerance range until the pulse intensity rising phase T11 ends and the pulse intensity holding phase T12 begins, the patient can be deemed to have tolerated the initial intensity level. Therefore, in subsequent electrical stimulation pulse sequences, when the electrical stimulation intensity maintained during the pulse intensity holding phase T12 is less than or equal to the initial intensity level, the duration of the pulse intensity rising phase T11 can be shortened, or even shortened to zero. In addition, it should be noted that for any electrical stimulation pulse sequence, the duration of any of the phases, including the pulse intensity maintenance phase T12, the pulse intensity decrease phase T13, and the rest period T2, can be 0.

[0057] Studies have shown that the intensity of electrical stimulation can be reduced at any point during the pulse stimulation period T1 in an electrical stimulation pulse sequence. However, increasing the intensity at certain stages may cause the intensity to exceed the patient's tolerance during the subsequent pulse intensity maintenance phase T12, leading to discomfort or tingling sensations and affecting the safety of electrical stimulation.

[0058] Generally, in the field of medical devices, according to standards such as YY 0607-2007-Medical Electrical Equipment Part 2: Safety of Nerve and Muscle Stimulators, electrical stimulation applied to the human body needs to be adjusted in increments of no more than 1mA or 1V. Therefore, electrical stimulation devices can have dozens of adjustment levels. During electrical stimulation therapy, the intensity of the electrical stimulation is adjusted based on actual biofeedback or the patient's subjective feelings. Taking an initial level of 50 as an example, if the patient feels that the intensity of level 50 is insufficient in the previous electrical stimulation pulse sequence, and increases the level to 55, and finds the intensity of this level tolerable, then after the sequence ends and before entering the next electrical stimulation pulse sequence, the pulse intensity maintenance phase T12 maintains an intensity of level 55. However, during the pulse stimulation period T1, patients cannot actually distinguish which stage they are in. If a patient increases the intensity during the pulse intensity increase phase (in the pulse intensity increase phase T11) or after the pulse intensity has started to decrease (in the pulse intensity decrease phase T13), they may misjudge their own tolerance level. If they cannot actually tolerate the intensity of 55, they will experience discomfort in the next pulse stimulation sequence.

[0059] Specifically, if a patient increases the intensity level during the pulse intensity increase phase (T11), the intensity of the electrical stimulation during the pulse intensity maintenance phase (T12) will exceed the patient's tolerance. For example, if a patient mistakenly believes that the intensity has reached level 50 when it reaches level 47 and increases it by 5 levels, the device will maintain the intensity at level 55 during the pulse intensity maintenance phase (T12) after reaching level 55, exceeding the patient's tolerance and causing stinging or burning.

[0060] If a patient increases the intensity level during the pulse intensity decrease phase (T13), the intensity of the electrical stimulation in the pulse intensity maintenance phase (T12) of the next electrical stimulation pulse sequence will exceed the patient's tolerance. For example, if a patient mistakenly believes the electrical stimulation intensity is still at level 50 when it drops to level 47, and increases it by 5 levels, the device can only increase the intensity to level 52 according to the user's operation. If the patient subjectively feels that it is tolerable at this point, then the patient is actually tolerating level 52. However, because the patient cannot know the actual electrical stimulation output, based on their operation, they will subjectively believe that they can tolerate level 55. When entering the next electrical stimulation pulse sequence, the intensity is based on the adjusted level 55, which exceeds the patient's actual tolerance of level 52. Therefore, the patient will experience discomfort during the pulse intensity maintenance phase (T12) of the next electrical stimulation pulse sequence.

[0061] To address the aforementioned problems, embodiments of the present invention provide a scheme for increasing the intensity level of electrical stimulation during the pulse intensity maintenance phase. This scheme can be applied to a controller in an electrical stimulation device, which controls the stimulator to apply electrical stimulation. The stimulator may include a control unit and electrodes. The electrodes may be attached to the patient's skin or other tissue surface. The control unit provides stimulation signals (e.g., voltage or current signals) to the electrodes, causing the electrodes to apply electrical stimulation to the patient's body tissue. Exemplarily, the control unit and electrodes may be integrated or separate, and the controller and control unit may be integrated or separate; neither is limited herein.

[0062] Figure 4 This is a schematic flowchart of an electrical stimulation intensity adjustment method provided in an embodiment of the present invention. See also... Figure 4 The method for adjusting the intensity of electrical stimulation includes the following steps:

[0063] S110. Obtain the upshift signal and record the moment the signal is obtained.

[0064] The electrostimulation device may include a human-machine interface (HMI) module, connected to or integrated into the controller. The HMI module may be, for example, a button, knob, or touchscreen, through which the user transmits a boost signal. Exemplarily, the boost signal may be a single-level boost signal or a multi-level boost signal, with the specific number of levels adjustable according to actual needs. Exemplarily, the electrostimulation device may include a control device electrically connected to the electrodes; functional modules such as the controller, control unit, HMI module, and display module can all be integrated into the same control device. Alternatively, the electrostimulation device may include a separate control device and a stimulation device. The control device may be, for example, a computer or mobile phone, with the controller (e.g., a processor) located within it. The stimulation device may be, for example, an electrode rod with an integrated control unit, or the stimulation device may include a separate control unit (e.g., a device host) and electrodes. Functional modules such as the HMI module and display module can be integrated into either the control device or the stimulation device.

[0065] S120. When the signal acquisition time is in the pulse intensity holding phase, determine whether the time interval between the signal acquisition time and the end time of the pulse intensity holding phase is greater than a preset time interval; wherein, the preset time interval is determined according to the upshift signal; if yes, then execute S130; if no, then execute S140.

[0066] In this step, it can be determined whether the signal acquisition time is within the pulse intensity holding phase. If so, the time interval can be further determined. If not, S140 can be executed directly.

[0067] For example, the preset time interval includes at least the time required to increase the intensity from the current level to the target level corresponding to the upshift signal. The current level is the level during the pulse intensity maintenance phase of the current electrical stimulation pulse sequence. The target level equals the current level plus the number of levels that need to be increased according to the upshift signal. In addition, the preset time interval may also include the signal transmission time in the electrical stimulation device, such as the signal interaction time between the controller and the stimulator. When the time interval between the signal acquisition moment and the end moment of the pulse intensity maintenance phase is greater than the preset time interval, it indicates that the remaining time of the pulse intensity maintenance phase is sufficient to complete the upshift adjustment based on the upshift signal; otherwise, it can be considered that the remaining time does not meet the adjustment requirements of the upshift signal, and the electrical stimulation intensity cannot be increased.

[0068] S130, Increase the intensity of electrical stimulation according to the upshift signal.

[0069] For example, when the boost signal is a multi-level boost signal, the electrical stimulation intensity can be automatically controlled to gradually increase according to the multi-level boost signal, so that the increase in electrical stimulation intensity meets the requirements of national standards, while avoiding discomfort to the patient caused by abrupt increases in electrical stimulation intensity. Specifically, the national standard may be the following standard specified in "YY 0607-2007 - Medical Electrical Equipment Part 2: Safety for Nerve and Muscle Stimulators": The stimulator must be equipped with an output amplitude controller that allows continuous adjustment of the stimulator's output amplitude from minimum to maximum, or intermittent adjustment in increments not exceeding 1mA or 1V. The device must be designed so that it has no energy output unless the output amplitude controller is preset to the minimum position; this requirement must also apply to situations where power is interrupted and then restored.

[0070] S140, Do not increase the intensity of electrical stimulation.

[0071] If the remaining time in the current electrical stimulation pulse sequence does not meet the adjustment time requirement of the upshift signal obtained in S110, after determining that the upshift signal will not be executed, the controller can continue to obtain other upshift signals and continue the judgment in S120.

[0072] In the electrical stimulation intensity adjustment method provided by this invention, the intensity increase is performed during the pulse intensity maintenance phase. This ensures that the intensity increase is based on the maximum intensity of the current electrical stimulation pulse sequence, avoiding increases during pulse intensity changes that could cause the electrical stimulation intensity in the subsequent pulse intensity maintenance phase to exceed the patient's tolerance, thus guaranteeing the safety of the electrical stimulation intensity adjustment. Furthermore, this invention performs the intensity increase adjustment when the time interval between the signal acquisition time and the end time of the pulse intensity maintenance phase is greater than a preset time interval. This ensures that intensity adjustment based on the intensity increase signal can be completed during the pulse intensity maintenance phase, while avoiding the impact of the intensity increase operation on the duration of the current pulse intensity maintenance phase, and consequently, avoiding any impact on the timing of subsequent treatment processes. Therefore, compared to existing technologies, this invention reduces the risk of the electrical stimulation intensity increase exceeding the patient's tolerance, improving the safety of intensity increase adjustment.

[0073] The above embodiments exemplify the core idea of ​​completing the upshift adjustment during the pulse intensity holding phase. The following describes the possible specific implementation methods of this method, but it is not intended to limit the present invention.

[0074] Figure 5 This is a schematic flowchart of another method for adjusting the intensity of electrical stimulation provided in an embodiment of the present invention. See also... Figure 5 In one embodiment, optionally, the electrical stimulation intensity adjustment method includes:

[0075] S210. Obtain the upshift signal and record the moment the signal is obtained.

[0076] S220: Determine the target gear based on the upshift signal and the current gear.

[0077] The target gear is the sum of the number of gears corresponding to the upshift signal and the current gear value.

[0078] S230. Determine the preset time interval based on the adjustment time required to upgrade from the current gear to the target gear, and the information interaction time between the controller and the stimulator.

[0079] Specifically, the information exchange between the controller and the stimulator refers to the information interaction between the controller and the control unit. This interaction can include the controller transmitting control commands to the control unit and the control unit providing feedback on command execution status to the controller. The preset time interval is greater than or equal to the sum of the adjustment time required to upgrade from the current gear to the target gear and the information interaction time between the controller and the stimulator. Specifically, it can be a value calculated based on the total time mentioned above. For example, if the upgrade signal is a +5 gear signal, and the time for data interaction between the controller and the stimulator during the entire upgrade operation is, for example, 0.3 seconds, and upgrading 5 times requires an additional 1.5 seconds, then the total time required is 1.8 seconds. Therefore, the final preset time interval can be greater than or equal to 1.8 seconds, for example, set to 1.8 seconds; or calculated to be 2 seconds, to ensure the effectiveness of the time duration during the actual gear upgrade adjustment process.

[0080] S240. Based on the upshift signal, the pulse intensity holding phase is divided into an allowable adjustment sub-phase and an inactive adjustment sub-phase; wherein, the duration of the inactive adjustment sub-phase is greater than or equal to a preset time interval.

[0081] In step S230, after determining the preset time interval based on the upshift signal, this step can divide the pulse intensity holding phase into a time-continuous allowable adjustment sub-phase and an inactive adjustment sub-phase based on the preset time interval. It should be noted that the duration of the inactive adjustment sub-phase is a variable that changes with the upshift signal. Specifically, the more gears to be shifted in the upshift signal, the longer the total time required to complete the adjustment, and consequently, the longer the duration of the inactive adjustment sub-phase.

[0082] S250. Determine whether the signal acquisition time is within the allowable adjustment sub-stage; if yes, execute S260; if no, execute S270.

[0083] Specifically, when the signal acquisition time is within the allowable adjustment sub-stage, it indicates that the time interval between the signal acquisition time and the cutoff time of the pulse intensity holding stage is greater than a preset time interval. This embodiment divides the pulse intensity holding stage according to the upshift signal, and determines whether the remaining time in the pulse intensity holding stage from the signal acquisition time meets the time requirement for upshift adjustment by judging the sub-stage in which the signal acquisition time is located, thus providing a method for judging the adjustment timing.

[0084] S260: Increase the intensity of electrical stimulation according to the upshift signal.

[0085] In one implementation, optionally, the upshift signal is a multi-level upshift signal. The step specifically includes: gradually increasing the electrical stimulation intensity from the current level until the level is increased to the target level corresponding to the multi-level upshift signal; wherein the preset time interval includes the upshift time from the current level to the target level.

[0086] In existing technologies, electrical stimulation devices typically only have a single "+" button for increasing intensity, with each click increasing the stimulation level by one level. If a patient needs multiple levels of intensity, they must repeatedly press the "+" button to increase the intensity one level at a time, a cumbersome process. This invention addresses this by providing a multi-level increase signal, essentially a "+N levels" button, where N is a positive integer greater than 1, such as +5 or +10 levels. This effectively simplifies the user experience and improves the overall experience. For example, the handheld device of the stimulation device, such as a mobile phone, can display virtual buttons for increasing intensity levels (+5, +1, +10, etc.). After pressing the corresponding virtual button, the electrical stimulation output automatically increases level by level. For instance, when selecting +5, the patient perceives only one press of the button, but the electrical stimulation output continuously increases by one level five times. The advantages of this setup are as follows: patients do not need to perform multiple button presses, effectively reducing the time the controller spends acquiring upgrade signals; simultaneously, when the controller directly transmits multi-level upgrade signals to the stimulator, it also effectively reduces frequent interactions between the controller and the stimulator, thereby reducing the time required for electrical stimulation adjustment. Furthermore, this embodiment uses an automatic, step-by-step adjustment method with a transitional approach to increase the intensity of electrical stimulation, ensuring that the intensity adjustment process of the electrical stimulation device meets the requirements of medical device standards and avoiding the harm to patients caused by abrupt increases in stimulation intensity.

[0087] It should be noted that this approach is particularly suitable for scenarios where the boost signal is a multi-level boost signal. When the boost signal is a level 1 boost signal, because the electrical stimulation modulation corresponding to level 1 is limited, even if it is performed during the pulse intensity rising / falling phase, the patient's subjective discomfort is relatively weak, and the impact on the subsequent pulse intensity holding phase is minimal. However, with multi-level boost signals, if the boost is performed outside the holding phase, it will lead to strong discomfort during the subsequent pulse intensity holding phase. In this case, it is especially necessary to determine the timing of the boost in advance.

[0088] It is also important to emphasize that the determination of the progressive intensity increase is closely related to the preset interval time. Progressive intensity increases are automatic, and the time required to complete each increase is relatively long. If the time interval between the signal acquisition time and the end time of the pulse intensity holding phase is not longer than the preset time interval, it cannot be guaranteed that the progressive intensity increase can be reliably and accurately completed before the end of the pulse intensity holding phase, affecting the intensity increase effect. For example, if progressive intensity increases continue after the pulse intensity holding phase has ended, that is, continue during the pulse intensity decrease phase, the increase and decrease of electrical stimulation intensity will occur simultaneously. This may lead to two problems: firstly, it may cause control errors in the electrical stimulation intensity adjustment; secondly, it may prevent the electrical stimulation intensity from reaching the target intensity corresponding to the increase signal, causing the patient to misjudge their own tolerance.

[0089] S270, Do not increase the intensity of electrical stimulation.

[0090] In this embodiment, reliable adjustment of the electrical stimulation intensity is achieved through steps S210-S270.

[0091] The above embodiments exemplify the process by which an electrical stimulation device determines whether to increase the intensity based on a user-supplied signal, and how it automatically performs a step-by-step increase. However, since the increase signal is a multi-level signal, the target intensity may have already exceeded the user's tolerance threshold. To address this issue, the inventors have added a pause mechanism to the adjustment method provided in the above embodiments, allowing the user to promptly stop the further increase in intensity during the increase of electrical stimulation, thus controlling the upper limit of the electrical stimulation intensity. This pause mechanism is described in detail below.

[0092] Optionally, based on the above embodiments, the electrical stimulation intensity adjustment method further includes:

[0093] Obtain a pause / upgrade signal; based on the pause / upgrade signal, stop increasing the intensity of electrical stimulation and maintain the current intensity level for electrical stimulation.

[0094] The pause / upgrade signal can be provided by setting a pause button (e.g., a physical or virtual button) in the human-computer interaction module. When the user feels uncomfortable and presses the pause button, the controller can receive the pause / upgrade signal and promptly stop the further increase of the electrical stimulation intensity level.

[0095] For example, after the control signal stops increasing the electrical stimulation intensity level, the subsequent adjustment process can take several forms. For instance, it can maintain the current level until the pulse intensity holding phase ends, until another intensity adjustment signal is received, or continue the increase operation corresponding to the paused increase signal. Taking an initial intensity of 50 levels in the pulse intensity holding phase, an increase signal of +5 levels, and a pause after reaching level 53 as an example: If no control signal is received after the pause, level 53 can be maintained until the pulse intensity holding phase ends. If another intensity adjustment signal is received after the pause, such as increasing by 1 level, increasing by multiple levels, decreasing by 1 level, or decreasing by multiple levels, the electrical stimulation intensity can be adjusted based on the received intensity adjustment signal, building upon level 53. When the user presses the pause button again after the pause, the increase operation can continue according to the previous increase signal, completing the remaining 2 levels of intensity increase, i.e., increasing the electrical stimulation intensity from level 53 to level 55.

[0096] This embodiment is configured in this way to effectively improve the controllability and flexibility of the adjustment method.

[0097] Based on the above embodiments, optionally, the upsampling signal can be acquired multiple times during the pulse intensity holding phase. The specific implementation of this scheme is described below.

[0098] In one embodiment, the electrical stimulation intensity adjustment method may optionally include the following steps:

[0099] During or after the increase in electrical stimulation intensity level, at least one further increase signal is obtained.

[0100] The number of gear adjustments corresponding to different upshift signals can be the same or different.

[0101] After each upgrade signal is acquired, the number of remaining adjustable levels between the target level corresponding to this upgrade signal and the current level is determined. The time interval between the acquisition time of this upgrade signal and the end time of the pulse intensity maintenance phase (denoted as the remaining time) is then checked to see if it meets the adjustment duration requirements for all remaining adjustable levels. If yes, the target level corresponding to this upgrade signal is used as the target adjustment level, and the electrical stimulation intensity is increased in multiple levels. If not, the target level corresponding to the previous upgrade signal is used as the target adjustment level, and the electrical stimulation intensity is increased in multiple levels.

[0102] Specifically, when the current upgrade signal is acquired during the increase of the electrical stimulation intensity level corresponding to the previous upgrade signal, the number of remaining levels to be adjusted is the number of incomplete levels in the previous upgrade signal plus the number of levels corresponding to the current upgrade signal. When the current upgrade signal is acquired after the increase of the electrical stimulation intensity level corresponding to the previous upgrade signal is completed, the number of remaining levels to be adjusted is the number of levels corresponding to the current upgrade signal.

[0103] When the remaining time meets the adjustment duration requirements for all remaining gears to be adjusted, it means that the adjustment process corresponding to this upshift signal can be completed within the pulse intensity holding phase. Therefore, the target gear corresponding to this upshift signal can be used as the target adjustment gear. When the remaining time does not meet the total adjustment duration requirements for all remaining gears to be adjusted, it means that the adjustment process corresponding to this upshift signal cannot be completed within the pulse intensity holding phase. In this case, it is only necessary to complete the upshift adjustment corresponding to the previous upshift signal. If the previous upshift adjustment has already been completed, then no further upshifting will be performed.

[0104] Based on the above embodiments, optionally, a complete treatment process can be a cyclical process consisting of multiple treatment stages, and a treatment stage can be a cyclical process consisting of multiple electrical stimulation pulse sequences. Within a sequence combination, some electrical stimulation pulse sequences may have different stimulation levels during the pulse intensity maintenance phase. This difference can be achieved by setting at least one difference in the pulse width, amplitude, and frequency of the pulses in different electrical stimulation pulse sequences. The electrical stimulation device can store multiple treatment plans, each corresponding to a different treatment process, and thus corresponding to different treatment effects. These effects include, but are not limited to, analgesia, anti-inflammation, massage, neuromuscular stimulation, promotion of nerve recovery, increase in muscle volume, and improvement in muscle strength and quality. Different treatment processes can correspond to different stage combinations, and different treatment stages can correspond to different sequence combinations.

[0105] To simplify the method of adjusting electrical stimulation intensity and avoid the complex process of individually increasing the intensity of multiple electrical stimulation pulse sequences within a sequence combination to test tolerance, after receiving the increase signal, the intensity can be increased according to the increase signal during the pulse intensity maintenance phase of the highest-intensity electrical stimulation pulse sequence in the current sequence combination upon its arrival. If the patient still tolerates the intensity of the highest-intensity electrical stimulation pulse sequence after the increase, it can be assumed that the patient will also tolerate the other electrical stimulation pulse sequences in the sequence combination after the increase signal. Therefore, when the sequence combination is run again, the increased intensity can be directly applied to each electrical stimulation pulse sequence in the sequence combination. Furthermore, after receiving the increase signal, the intensity can be increased according to the increase signal during the pulse intensity maintenance phase of the highest-intensity electrical stimulation pulse sequence in the current combination upon its arrival, further simplifying the adjustment process, reducing the number of adjustments to the electrical stimulation pulse sequences, and thus significantly shortening the adjustment time, allowing the treatment plan to be executed faster and improving efficiency.

[0106] Based on the above implementation methods, there are several ways to optionally increase the intensity of electrical stimulation in multiple levels. Several of these methods will be described below.

[0107] Figure 6 This is a schematic diagram of a method for increasing the intensity level of electrical stimulation according to an embodiment of the present invention. See also... Figure 6 In one embodiment, optionally, after receiving multiple (N) level boost signals SupN provided by the user, the controller 10 can directly transmit the multiple level boost signals SupN to the stimulator 20; the stimulator 20 decomposes the multiple level boost signals SupN into multiple level 1 boost signals Sup1, and repeatedly performs level 1 adjustment to achieve automatic step-by-step increase of the electrical stimulation intensity level according to the multiple level boost signals SupN. For example, during the automatic step-by-step increase process, the user can pause the level increase at any time, so the number of times the stimulator 20 performs level 1 adjustment M is less than or equal to N.

[0108] Additionally, the stimulator 20 can transmit a synchronization signal Ssyn to the controller 10, enabling the controller 10 to obtain the current electrical stimulation intensity level. For example, the stimulator 20 can automatically send the synchronization signal Ssyn back to the controller 10 after each preset number of intensity increases. For instance, the stimulator 20 can send the synchronization signal Ssyn back to the controller 10 after each intensity increase to ensure timely feedback; or, the stimulator 20 can send the synchronization signal Ssyn back to the controller 10 only after N intensity increases have been completed, to avoid frequent information interaction between the controller 10 and the stimulator 20. Alternatively, the controller 10 can periodically query the stimulator 20 to cause it to transmit the synchronization signal Ssyn, thereby allowing the controller 10 to periodically obtain the electrical stimulation intensity level.

[0109] Figure 7 This is a schematic diagram of another method for increasing the intensity level of electrical stimulation provided in an embodiment of the present invention. See also... Figure 7 In another embodiment, optionally, after receiving the multi-level boost signal SupN provided by the user, the controller 10 can decompose the multi-level boost signal SupN into multiple level 1 boost signals Sup1, and repeatedly transmit the level 1 boost signals Sup1 to the stimulator 20, causing the stimulator 20 to perform a level increase adjustment. Similarly, the automatic step-by-step increase of the electrical stimulation intensity level can be achieved based on the multi-level boost signals SupN. This setting simplifies the control logic of the stimulator 20, requiring only the receipt of level 1 boost signals Sup1 and the execution of the corresponding level increase operation. For example, during the automatic step-by-step increase process, the user can pause the level increase at any time; therefore, the number of times the controller 20 cyclically sends the level 1 boost signal Sup1, M, is less than or equal to N.

[0110] For example, in this embodiment, the stimulator 20 may also transmit a synchronization signal Ssyn to the controller 10. For details, please refer to the relevant description in the above embodiments, which will not be repeated here.

[0111] The controller 10 or stimulator 20 can use any decomposition method in the prior art to split the multi-level boost signal SupN into a series of level 1 boost signals Sup1. Alternatively, the multi-level boost signal SupN can be split into multiple sub-boost signals, where the number of levels k corresponding to each sub-boost signal is between 1 and N, and the number of levels corresponding to each sub-boost signal can be the same or different. When k≠1, the stimulator 20 still automatically and progressively increases the level until the electrical stimulation intensity reaches level k.

[0112] Based on the above embodiments, optionally, the adjustment time corresponding to each gear can be the same, that is, the gear shifting process can adopt a process with uniformly varying duration.

[0113] Alternatively, at least two gear levels can be configured with different adjustment durations. For example, the adjustment duration for each gear level can be set to decrease progressively with each increase in gear level. That is, the gear increase process can employ a gradual increase in speed to reduce the total adjustment time while ensuring smooth adjustment. This allows for a longer time margin in the adjustment sub-stages, increasing the time and probability available for multiple gear increases during the pulse intensity maintenance phase. The reduction in adjustment duration for each gear level can be the same to achieve a linear decrease in adjustment duration; for example, setting it to 0.6 seconds for increasing one gear level, 0.5 seconds for the next, 0.4 seconds for the next, and so on. Alternatively, the reduction in adjustment duration for each gear level can be different to achieve a non-linear decrease in adjustment duration; for example, setting it to 0.6 seconds for increasing one gear level, 0.55 seconds for the next, 0.48 seconds for the next, and so on.

[0114] Based on the above embodiments, optionally, the electrical stimulation intensity adjustment amount corresponding to each level is the same, that is, the process of increasing the level can adopt a process of uniformly changing the adjustment amount.

[0115] Alternatively, at least two different electrical stimulation intensity adjustment levels can be set. For example, as the intensity level increases, the adjustment amount for each level can be progressively decreased. Since higher intensity levels are more likely to exceed the patient's tolerance threshold, this setting is equivalent to increasingly cautiously controlling the intensity increase as the intensity level increases, avoiding the situation where, during later adjustments after multiple increases, the intensity value exceeds the patient's tolerance threshold excessively. For example, this progressive decrease can be linear or non-linear, depending on the specific circumstances, and is not limited here.

[0116] Alternatively, as the intensity levels increase, the corresponding electrical stimulation intensity adjustment can be set to increase progressively for each level. This setting, compared to setting the same adjustment amount for each level, allows for achieving the required total electrical stimulation intensity with fewer level adjustments, thus reducing the total adjustment time. For example, this progressive increase can be linear or non-linear, depending on the specific circumstances, and is not limited here.

[0117] It should be noted that, according to national standards, the electrical stimulation adjustment (increase in electrical stimulation intensity) for each level should not exceed 1mA (under current stimulation) or 1V (under voltage stimulation).

[0118] Based on the above embodiments, optionally, the electrical stimulation device further includes a display module, which is controlled by the controller to display information. The display interface may include real-time gear level, current electrical stimulation pulse sequence information (e.g., pulse frequency, pulse width, pulse energy, etc.). As the adjustment process proceeds, the controller can control the real-time updating of this information to make the adjustment process more intuitive. For example, the controller can control the display interface to refresh based on the synchronization signal transmitted by the stimulator, achieving synchronization between the display process and the control process. Alternatively, after obtaining the gear upgrade signal, the controller can directly control the display interface to refresh according to a preset gear upgrade time and frequency without waiting for the stimulator's synchronization signal, achieving pseudo-synchronization between the display process and the control process; and after obtaining the stimulator's synchronization signal, adjust the information in the display interface accordingly to achieve actual synchronization between the display process and the control process.

[0119] The adjustment method will be described below through specific embodiments.

[0120] For example, if the boost signal is a level 5 boost signal, and the total duration of the pulse intensity maintenance phase of the current electrical stimulation pulse sequence is 10 seconds, the total time required to increase the boost by 5 levels is 2 seconds. Therefore, the first 8 seconds of the pulse intensity maintenance phase can be set as the allowable adjustment sub-phase, and the last 2 seconds as the inactive adjustment sub-phase. During the allowable adjustment sub-phase, the boost signal can be executed, and the boost level can be increased arbitrarily multiple times; during the inactive adjustment sub-phase, the boost signal cannot be executed. For example, if a level 5 boost signal is obtained at 2 seconds, the boost operation can be performed, and the boost operation ends at 4 seconds. Then, for example, a boost of 5 levels can be performed at 7 seconds, the boost operation ends at 9 seconds, and the pulse intensity maintenance phase ends at 10 seconds, entering the pulse intensity decrease phase. However, if a level 5 boost signal is obtained at 8.5 seconds, the boost operation cannot be performed.

[0121] For example, if the first received signal is a 5-level boost signal, requiring 2 seconds to adjust, then any time within the first 8 seconds can receive and execute the 5-level boost. If a subsequent 10-level boost signal is received, requiring, for example, 4 seconds to increase by 10 levels, then the signal must be received within the first 6 seconds to execute the 10-level boost operation. For instance, the boost buttons include "+1 level," "+5 level," and "+10 level." The total duration requirement for "+5 level" is 2 seconds, and for "+10 level" it is 4 seconds. If the "+5 level" button is clicked at the 2nd second of the pulse intensity hold phase, the boost will end at the 4th second. Subsequently, "+5 level" can be clicked again before the 8th second, or "+10 level" can be clicked before the 6th second. Clicking "+10 level" at the 7th second will not execute, but clicking "+5 level" at the 7th second will execute.

[0122] In summary, the electrical stimulation intensity adjustment method provided by the embodiments of the present invention can ensure that the intensity adjustment is performed during the pulse intensity maintenance phase of the electrical stimulation pulse sequence and is successfully completed before the end of the pulse intensity maintenance phase.

[0123] This invention also provides an electrical stimulation intensity adjustment device, which can execute the electrical stimulation intensity adjustment method provided in any embodiment of this invention, and has the corresponding functional modules and beneficial effects of the method. Figure 8 This is a schematic diagram of the structure of an electrical stimulation intensity adjustment device provided in an embodiment of the present invention. See also... Figure 8 The electrical stimulation intensity adjustment device includes: a signal acquisition module 331, a duration determination module 332, and an intensity adjustment module 333.

[0124] The signal acquisition module 331 acquires the up-level signal and records the signal acquisition time. The duration determination module 332 determines whether the time interval between the signal acquisition time and the end time of the pulse intensity maintenance phase is greater than a preset time interval when the signal acquisition time is within the pulse intensity maintenance phase; the preset time interval is determined based on the up-level signal. The intensity adjustment module 333 increases the electrical stimulation intensity level according to the up-level signal when the time interval between the signal acquisition time and the end time of the pulse intensity maintenance phase is greater than the preset time interval.

[0125] Based on the above embodiments, optionally, the duration determination module 332 may include a stage division unit and a determination unit. The stage division unit is used to divide the pulse intensity holding stage into an allowable adjustment sub-stage and an inallowed adjustment sub-stage according to the upshift signal; wherein the duration of the inallowed adjustment sub-stage is greater than or equal to a preset time interval. The determination unit is used to determine whether the signal acquisition time is within the allowable adjustment sub-stage.

[0126] Specifically, the preset time interval is obtained by: determining the target gear based on the upshift signal and the current gear; determining the preset time interval based on the adjustment time required to shift from the current gear to the target gear, and the information interaction time between the controller and the stimulator.

[0127] Based on the above embodiments, optionally, the electrical stimulation intensity adjustment device further includes: a continued adjustment module, used to acquire at least one more upgrade signal during or after the electrical stimulation intensity level is increased. After each upgrade signal is acquired, the number of remaining adjustable levels between the target level corresponding to the current upgrade signal and the current level is determined; and it is determined whether the time interval between the acquisition time of the current upgrade signal and the end time of the pulse intensity holding phase meets the adjustment duration requirements of all remaining adjustable levels. If yes, the target level corresponding to the current upgrade signal is used as the target adjustment level, and the electrical stimulation intensity is increased in multiple levels. If no, the target level corresponding to the previous upgrade signal is used as the target adjustment level, and the electrical stimulation intensity is increased in multiple levels.

[0128] Based on the above embodiments, optionally, the upshift signal is a multi-level upshift signal; the intensity adjustment module 333 is specifically used to increase the electrical stimulation intensity level by level from the current level until the level is upshifted to the target level corresponding to the multi-level upshift signal; wherein, the preset time interval includes the upshifting time from the current level to the target level.

[0129] Based on the above embodiments, the electrical stimulation intensity adjustment device may optionally include: a pause module, used to acquire a pause-up signal; and to stop increasing the electrical stimulation intensity level according to the pause-up signal, and maintain the current level for electrical stimulation.

[0130] This invention also provides an electrical stimulation device for performing the electrical stimulation intensity adjustment method provided in any embodiment of this invention, and has corresponding beneficial effects. Figure 9 This is a schematic diagram of the structure of an electrical stimulation device provided in an embodiment of the present invention. See also... Figure 9 The electrical stimulation device may include: a stimulator 20, a controller 10, and a memory 30. Both the stimulator 20 and the memory 30 are communicatively connected to the controller 10. The memory 30 stores a computer program executable by the controller 10, which is then executed by the controller 10 to perform the electrical stimulation intensity adjustment method provided in any embodiment of the present invention.

[0131] Exemplarily, the control units in controller 10 and stimulator 20 can be integrated into a single control device. Alternatively, controller 10 and stimulator 20 can be separate entities, for example, controller 10 and memory 30 can be integrated into a control device, where controller 10 can be software within the control device or a remote control device. Stimulator 20 can be an electrode with an integrated control unit, or a separately configured and electrically connected control unit and electrode, the control unit may also be connected to memory 30. Controller 10 can control the adjustment process of stimulator 20 via wired or wireless transmission. Exemplarily, controller 10 may include application software, control buttons, or knobs; the electrodes in stimulator 20 can be sheet-like or rod-like, for attachment to human skin or other tissues, and the electrical stimulation output from the electrical stimulation device is provided to the human body via the electrodes.

[0132] For example, memory 30 may be a read-only memory (ROM) or a random access memory (RAM), etc. Memory 30 stores computer programs that can be executed by controller 10. Controller 10 can perform various appropriate actions and processes based on the computer programs stored in the read-only memory (ROM) or loaded from storage units into the random access memory (RAM). The RAM may also store various programs and data required for the operation of the electrical stimulation device. Controller 10, ROM, and RAM can be interconnected via a bus. Input / output (I / O) interfaces can also be connected to the bus.

[0133] Multiple components in an electrostimulation device are connected to an I / O interface, which may include: input units, such as keyboards, mice, buttons, etc.; output units, such as various types of displays, speakers, etc.; storage units, such as disks, optical discs, etc.; and communication units, such as network interface cards, modems, wireless transceivers, etc. The communication unit allows the electrostimulation device to exchange information / data with other devices through computer networks such as the Internet and / or various telecommunications networks.

[0134] Controller 10 can be a variety of general-purpose and / or special-purpose processing components with processing and computing capabilities. Some examples of controller 10 include, but are not limited to, a central processing unit (CPU), a graphics processing unit (GPU), various special-purpose artificial intelligence (AI) computing chips, various processors running machine learning model algorithms, digital signal processors (DSPs), and any suitable processor, controller, microcontroller, etc. Controller 10 performs the various methods and processes described above, such as the electrical stimulation intensity modulation method.

[0135] In some embodiments, the electrical stimulation intensity modulation method may be implemented as a computer program tangibly contained in a computer-readable storage medium, such as a storage unit. In some embodiments, part or all of the computer program may be loaded into and / or installed onto the electrical stimulation device via a ROM and / or communication unit. When the computer program is loaded into RAM and executed by the controller 10, one or more steps of the electrical stimulation intensity modulation method described above may be performed. Alternatively, in other embodiments, the controller 10 may be configured to perform the electrical stimulation intensity modulation method by any other suitable means (e.g., by means of firmware).

[0136] Various embodiments of the systems and techniques described above herein can be implemented in digital electronic circuit systems, integrated circuit systems, field-programmable gate arrays (FPGAs), application-specific integrated circuits (ASICs), application-specific standard products (ASSPs), systems-on-a-chip (SoCs), payload-programmable logic devices (CPLDs), computer hardware, firmware, software, and / or combinations thereof. These various embodiments may include implementations in one or more computer programs that can be executed and / or interpreted on a programmable system including at least one programmable processor, which may be a dedicated or general-purpose programmable processor, capable of receiving data and instructions from a storage system, at least one input device, and at least one output device, and transmitting data and instructions to the storage system, the at least one input device, and the at least one output device.

[0137] Computer programs used to implement the methods of the present invention may be written in any combination of one or more programming languages. These computer programs may be provided to a processor of a general-purpose computer, a special-purpose computer, or other programmable data processing device, such that when executed by the processor, the computer programs cause the functions / operations specified in the flowcharts and / or block diagrams to be performed. The computer programs may be executed entirely on a machine, partially on a machine, or as a standalone software package, partially on a machine and partially on a remote machine, or entirely on a remote machine or server.

[0138] In the context of this invention, a computer-readable storage medium can be a tangible medium that may contain or store a computer program for use by or in conjunction with an instruction execution system, apparatus, or device. A computer-readable storage medium may include, but is not limited to, electronic, magnetic, optical, electromagnetic, infrared, or semiconductor systems, apparatus, or devices, or any suitable combination thereof. Alternatively, a computer-readable storage medium may be a machine-readable signal medium. More specific examples of machine-readable storage media include electrical connections based on one or more wires, portable computer disks, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), optical fibers, portable compact disk read-only memory (CD-ROM), optical storage devices, magnetic storage devices, or any suitable combination thereof.

[0139] To provide interaction with the user, the systems and techniques described herein can be implemented on an electrostimulation device having: a display device (e.g., a CRT (cathode ray tube) or LCD (liquid crystal display) monitor) for displaying information to the user; and a keyboard and pointing device (e.g., a mouse or trackball) through which the user provides input to the electrostimulation device. Other types of devices can also be used to provide interaction with the user; for example, feedback provided to the user can be any form of sensory feedback (e.g., visual feedback, auditory feedback, or tactile feedback); and input from the user can be received in any form (including acoustic input, voice input, or tactile input).

[0140] The systems and technologies described herein can be implemented in computing systems that include backend components (e.g., as data servers), or computing systems that include middleware components (e.g., application servers), or computing systems that include frontend components (e.g., user computers with graphical user interfaces or web browsers through which users can interact with implementations of the systems and technologies described herein), or any combination of such backend, middleware, or frontend components. The components of the system can be interconnected via digital data communication of any form or medium (e.g., communication networks). Examples of communication networks include local area networks (LANs), wide area networks (WANs), blockchain networks, and the Internet.

[0141] For example, the electrical stimulation device can specifically be a pelvic floor muscle rehabilitation therapy device. The pelvic floor tissues of women play a vital role in maintaining the normal physiological state and function of the pelvic organs. Damage to the pelvic floor tissues due to pregnancy, childbirth, obesity, and prolonged sexual activity can lead to various pelvic floor dysfunctions and functional decline or loss, such as vaginal laxity, decreased vaginal contraction ability, and urinary incontinence, thus affecting women's normal lives. Therefore, pelvic floor muscle rehabilitation therapy is very important. In the pelvic floor muscle rehabilitation therapy device, the electrode pads can collect biofeedback information while outputting electrical stimulation. During the process of the patient performing corresponding contraction and relaxation movements according to the interface prompts, the electrodes are in the process of collecting information, transmitting the bioelectrical changes generated during muscle tissue activity, or biofeedback (this collection process will present muscle contraction, muscle strength level, etc., in a specific waveform or other form on the screen display). If the contraction and relaxation movements do not meet the standards, this can be detected by the electrode pads. At this time, electrical stimulation output will be intervened, releasing a current of a specific frequency and pulse width to electrically stimulate the muscles, thereby ensuring the treatment effect.

[0142] It should be understood that the various forms of processes shown above can be used, with steps reordered, added, or deleted. For example, the steps described in this invention can be executed in parallel, sequentially, or in different orders, as long as the desired result of the technical solution of this invention can be achieved, and this is not limited herein.

[0143] The specific embodiments described above do not constitute a limitation on the scope of protection of this invention. Those skilled in the art should understand that various modifications, combinations, sub-combinations, and substitutions can be made according to design requirements and other factors. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of this invention should be included within the scope of protection of this invention.

Claims

1. A method for adjusting the intensity of electrical stimulation, characterized in that, Applied to a controller, the controller being used to control the stimulator to apply electrical stimulation; During the application of electrical stimulation, the electrical stimulation pulse sequence includes a pulse intensity rise phase and a pulse intensity hold phase; The method for adjusting the intensity of electrical stimulation includes: Acquire the upshift signal and record the moment the signal is acquired; When the signal acquisition time is within the pulse intensity holding phase, it is determined whether the time interval between the signal acquisition time and the end time of the pulse intensity holding phase is greater than a preset time interval; wherein, the preset time interval is determined according to the upshift signal; If so, the intensity level of electrical stimulation will be increased according to the aforementioned upgrade signal; The preset time interval is obtained in the following ways: Determine the target gear based on the upshift signal and the current gear; The preset time interval is determined based on the adjustment time required to shift from the current gear to the target gear, and the information interaction time between the controller and the stimulator.

2. The method for adjusting the intensity of electrical stimulation according to claim 1, characterized in that, Determining whether the time interval between the signal acquisition time and the pulse intensity hold phase end time is greater than a preset time interval includes: Based on the upshift signal, the pulse intensity holding phase is sequentially divided into an allowable adjustment sub-phase and an inactive adjustment sub-phase; wherein, the duration of the inactive adjustment sub-phase is greater than or equal to the preset time interval; Determine whether the signal acquisition time is within the allowed adjustment sub-stage; If so, the intensity of the electrical stimulation is increased according to the aforementioned upgrade signal.

3. The method for adjusting the intensity of electrical stimulation according to claim 1, characterized in that, Also includes: During the process of increasing the intensity level of electrical stimulation, or after the increase in the intensity level of electrical stimulation is completed, at least one more increase signal shall be obtained; After each upshift signal is acquired, the number of remaining gears to be adjusted between the target gear corresponding to this upshift signal and the current gear is determined; and the time interval between the acquisition time of this upshift signal and the cutoff time of the pulse intensity holding phase is determined to meet the gear adjustment time requirements of all remaining gears to be adjusted. If so, the target level corresponding to this upgrade signal will be used as the target adjustment level to increase the electrical stimulation intensity in multiple levels. If not, then the target level corresponding to the previous upgrade signal is used as the target adjustment level, and the electrical stimulation intensity is increased in multiple levels.

4. The method for adjusting the intensity of electrical stimulation according to claim 1, characterized in that, The upshift signal is a multi-level upshift signal; The intensity level of electrical stimulation is increased according to the aforementioned upgrade signal, including: The electrical stimulation intensity is gradually increased from the current level until the level is raised to the target level corresponding to the multi-level boost signal; wherein, the preset time interval includes the boost time from the current level to the target level.

5. The method for adjusting the intensity of electrical stimulation according to claim 1, 3, or 4, characterized in that, Also includes: Receive a pause upshift signal; The increase in electrical stimulation intensity level is stopped according to the pause signal, and the current level is maintained for electrical stimulation.

6. The method for adjusting the intensity of electrical stimulation according to claim 4, characterized in that, The adjustment time is the same for each gear; Alternatively, as the number of gears increases, the adjustment time for each gear decreases progressively.

7. The method for adjusting the intensity of electrical stimulation according to claim 4, characterized in that, The electrical stimulation intensity adjustment amount is the same for each gear level; Alternatively, as the number of gears increases, the intensity of electrical stimulation corresponding to each gear decreases progressively. Alternatively, as the number of gears increases, the intensity of electrical stimulation corresponding to each gear level increases progressively.

8. An electrical stimulation intensity adjustment device, characterized in that, include: The signal acquisition module is used to acquire upshift signals and record the moment of signal acquisition. The duration determination module is used to determine whether the time interval between the signal acquisition time and the end time of the pulse intensity maintenance phase is greater than a preset time interval when the signal acquisition time is in the pulse intensity maintenance phase; wherein, the preset time interval is determined according to the upshift signal; the preset time interval is obtained by: determining the target gear according to the upshift signal and the current gear; determining the preset time interval according to the adjustment time required to upshift from the current gear to the target gear, and the information interaction time between the controller and the stimulator; The intensity adjustment module is used to increase the intensity level of electrical stimulation according to the up-level signal when the time interval between the signal acquisition time and the cutoff time of the pulse intensity holding phase is greater than a preset time interval.

9. An electrical stimulation device, characterized in that, include: Stimulator, controller, and memory; Both the stimulator and the memory are communicatively connected to the controller. The memory stores a computer program that can be executed by the controller, and the computer program is executed by the controller to cause the controller to perform the electrical stimulation intensity adjustment method according to any one of claims 1-7.

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