Methods for adjusting electrical stimulation intensity and electrical stimulation equipment

Abstract

This invention discloses a method and device for adjusting electrical stimulation intensity. The method is applied to the electrical stimulation device, wherein during the application of electrical stimulation, the electrical stimulation pulse sequence includes an intensity increase phase and an intensity maintenance phase. The method includes: acquiring an intensity increase command, and determining whether the acquisition time of the intensity increase command falls within the intensity maintenance phase; if so, increasing the electrical stimulation intensity according to the intensity increase command. The maximum electrical stimulation intensity within the intensity maintenance phase is determined based on: the intensity increase command, the acquisition time of the intensity increase command, and the end time of the intensity maintenance phase. This invention improves the safety and reliability of electrical stimulation intensity adjustment.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a method 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 patient can control the intensity to decrease, and vice versa.

[0003] The application of electrical stimulation by an electrical stimulation device typically involves multiple sequences of electrical stimulation pulses. These sequences may include an intensity increase phase, an intensity maintenance phase, an intensity decrease phase, and a rest period. The next sequence begins after the previous one is completed, and the intensity adjustment made in the previous sequence is remembered and carried over to the next. If the timing of the intensity increase is inappropriate, the intensity during the maintenance phase may exceed the patient's tolerance. For example, increasing the intensity during the intensity increase phase of the current sequence may result in the maintenance phase exceeding the patient's tolerance. Conversely, increasing the intensity during the intensity decrease phase may lead to the maintenance phase exceeding the patient's tolerance, and simultaneous increases and decreases may cause control confusion in the device, affecting the reliability of intensity adjustment. Current technologies often neglect the timing of intensity adjustment, making it difficult to guarantee the safety and reliability of intensity increases. Summary of the Invention

[0004] This invention provides a method and device for adjusting the intensity of electrical stimulation to improve the safety and reliability of increasing the intensity of electrical stimulation.

[0005] In a first aspect, embodiments of the present invention provide an electrical stimulation intensity adjustment method applied to an electrical stimulation device, wherein during the electrical stimulation application process of the electrical stimulation device, the electrical stimulation pulse sequence includes an intensity increase phase and an intensity maintenance phase;

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

[0007] Obtain an intensity boost instruction and determine whether the intensity boost instruction is obtained during the intensity maintenance phase;

[0008] If so, the electrical stimulation intensity is increased according to the intensity increase command, wherein the determination of the maximum electrical stimulation intensity during the intensity maintenance phase includes: the intensity increase command, the time of acquisition of the intensity increase command, and the end time of the intensity maintenance phase.

[0009] Optionally, when the remaining adjustment time of the intensity maintenance phase is greater than or equal to the intensity increase requirement time, the maximum electrical stimulation intensity is the target electrical stimulation intensity corresponding to the intensity increase command; wherein, the remaining adjustment time is the interval between the acquisition time of the intensity increase command and the end time of the intensity maintenance phase, and the intensity increase requirement time is the time required to increase the electrical stimulation intensity to the target electrical stimulation intensity;

[0010] When the remaining adjustment time is less than the intensity increase requirement time, the maximum electrical stimulation intensity is the electrical stimulation intensity reached until the end of the intensity maintenance phase.

[0011] Optionally, the intensity increase instruction is an N-level increase instruction, where N is an integer greater than or equal to 2;

[0012] The step of increasing the intensity of electrical stimulation according to the intensity increase command includes:

[0013] The upshift N command is split into multiple upshift M commands, and the upshift M command is repeatedly executed before the upshift end condition is met, where 1 ≤ M < N;

[0014] The conditions for ending the intensity increase are: the N-level increase command is completed before the end of the intensity maintenance phase, or the increase in electrical stimulation intensity has continued until the end of the intensity maintenance phase.

[0015] Optionally, executing the M-mode command includes:

[0016] Before executing the M-gear command, determine whether the current moment is in the intensity maintenance phase;

[0017] If so, the electrical stimulation intensity is increased according to the M-level instruction; wherein, if the time interval between the current moment and the end moment of the intensity maintenance phase meets the duration requirement of the M-level adjustment, the M-level adjustment is completed; if the time interval between the current moment and the end moment of the intensity maintenance phase does not meet the duration requirement of the M-level adjustment, the electrical stimulation intensity is increased according to the M-level instruction until the end moment of the intensity maintenance phase.

[0018] If not, then stop increasing the intensity of electrical stimulation.

[0019] Optionally, executing the M-mode command includes:

[0020] Before executing the M-gear adjustment command, it is determined whether the M-gear adjustment can be completed before the end of the intensity maintenance phase;

[0021] If so, then adjust to M mode according to the M mode adjustment command.

[0022] If not, then stop increasing the intensity of the electrical stimulation.

[0023] Optionally, the electrical stimulation device includes a user terminal component and a stimulation terminal component connected in communication; the user terminal component is used to acquire the N-level increase command;

[0024] The upshift command is broken down into multiple upshift commands (M gear commands), and the upshift command (M gear command) is repeatedly executed before the upshift end condition is met, including:

[0025] The user terminal component splits the "add N" instruction into multiple "add M" instructions, and before the upgrade end condition is met, repeatedly sends the "add M" instructions to the stimulation terminal component, causing the stimulation terminal component to execute the "add M" instructions.

[0026] Optionally, the electrical stimulation device includes a user terminal component and a stimulation terminal component connected in communication, wherein the user terminal component is used to acquire the N-level increase command;

[0027] The upshift command is broken down into multiple upshift commands (M gear commands), and the upshift command (M gear command) is repeatedly executed before the upshift end condition is met, including:

[0028] The user terminal component sends the N-level increase command to the stimulation terminal component;

[0029] The stimulation end component splits the N-level increase command into multiple M-level increase commands, and repeatedly executes the M-level increase command before the level increase end condition is met.

[0030] Optionally, after each k-level adjustment, the stimulation terminal component feeds back electrical stimulation intensity information to the user terminal component, where 1≤k≤N;

[0031] Alternatively, the user terminal component may acquire electrical stimulation intensity information from the stimulation terminal component at preset time intervals.

[0032] Optionally, the user terminal component includes a control module for acquiring the N-level increase command and receiving the electrical stimulation intensity information;

[0033] The electrical stimulation device further includes: a display module, disposed in the user terminal component or the stimulation terminal component;

[0034] The method for adjusting the intensity of electrical stimulation also includes:

[0035] The control module controls the display module to display the electrical stimulation intensity value;

[0036] Specifically, the control module controls the display module to refresh the electrical stimulation intensity value according to the frequency of increasing the electrical stimulation intensity level based on the N-level increase instruction; or, when the control module receives the electrical stimulation intensity information, it controls the display module to refresh the electrical stimulation intensity value based on the electrical stimulation intensity information.

[0037] Optionally, M=1, and the instruction to add M gears is an instruction to add 1 gear.

[0038] Optionally, the electrical stimulation intensity adjustment method further includes:

[0039] Get the pause command;

[0040] The electrical stimulation intensity is stopped from increasing according to the pause command, and the current electrical stimulation intensity is maintained for electrical stimulation.

[0041] Secondly, embodiments of the present invention also provide an electrical stimulation device for performing the electrical stimulation intensity adjustment method provided in any embodiment of the present invention.

[0042] In the electrical stimulation intensity adjustment method provided by this invention, the increase in electrical stimulation intensity is controlled to occur during the intensity maintenance phase. This ensures that the intensity increase is based on the maximum electrical stimulation intensity of the current electrical stimulation pulse sequence, avoiding the problem of the electrical stimulation intensity exceeding the patient's tolerance during the subsequent intensity maintenance phase, which would occur if the intensity increase were performed during other intensity change phases. This ensures the safety of electrical stimulation intensity adjustment. Furthermore, this invention controls the intensity increase to end no later than the end of the intensity maintenance phase. This allows for the maximum possible increase in electrical stimulation intensity even when the remaining adjustment time in the intensity maintenance phase is insufficient. It also avoids conflicts between the intensity increase and the subsequent intensity reduction phase, and avoids the impact on the duration of the current intensity maintenance phase that might occur while waiting for the intensity increase to complete. This, in turn, avoids affecting the timing of subsequent treatment processes and improves the reliability of intensity adjustment. Therefore, compared to the prior art, this invention can improve the safety and reliability of electrical stimulation intensity increase.

[0043] 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

[0044] 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.

[0045] Figure 1 This is a schematic diagram of the treatment process of an electrical stimulation device provided in an embodiment of the present invention;

[0046] Figure 2 This is a pulse diagram illustrating the treatment process of an electrical stimulation device provided in an embodiment of the present invention;

[0047] Figure 3 This is a schematic diagram of an electrical stimulation pulse sequence provided in an embodiment of the present invention;

[0048] Figure 4 This is a schematic flowchart of an electrical stimulation intensity adjustment method provided in an embodiment of the present invention;

[0049] Figure 5 This is a schematic diagram of a method for increasing the intensity level of electrical stimulation provided in an embodiment of the present invention;

[0050] Figure 6 This is a schematic diagram of another method for increasing the intensity level of electrical stimulation provided in an embodiment of the present invention;

[0051] 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;

[0052] Figure 8 This is a schematic diagram of the structure of an electrical stimulation device provided in an embodiment of the present invention. Detailed Implementation

[0053] 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.

[0054] 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.

[0055] This invention provides a method for adjusting the intensity of electrical stimulation, applicable to applications requiring increased intensity from electrical stimulation devices. During the application of electrical stimulation, the method increases the intensity during a maintenance phase, based on the user's desired increase, and continues this increase until the end of the maintenance phase, ensuring the safety and reliability of the intensity increase. This method can be executed by the electrical stimulation device. The device can be an integrated unit, with the adjustment method executed by its control module; alternatively, the device can be a separate unit comprising a user-end component and a stimulation-end component, with the adjustment method implemented by both components working together. Specific implementation details are described below, and configurations can be tailored to specific needs in practical applications.

[0056] 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.

[0057] 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 an 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 energy and 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.

[0058] For the specific composition of the electrical stimulation pulse sequence, please refer to Figure 3For example, an electrical stimulation pulse sequence may include a pulse stimulation period T1 and a rest period T2. The pulse stimulation period T1 may include, in chronological order, an intensity increase phase T11, an intensity maintenance phase T12, and an intensity decrease phase T13, based on the changing trend of the pulse intensity envelope or the changing pattern of each pulse amplitude. During treatment, the duration of the intensity increase phase T11 of at least the first electrical stimulation pulse sequence is not zero. In the intensity increase phase T11, the amplitude of the electrical stimulation pulses (e.g., current magnitude) is gradually increased to establish the patient's tolerance to the electrical stimulation and to determine the patient's tolerance to the initial intensity at the start of treatment, ensuring the safety of the treatment process. If, until the end of the intensity increase phase T11 and into the intensity maintenance phase T12, the electrical stimulation intensity remains within the patient's tolerance range, it can be determined that the patient tolerates the initial intensity. Therefore, in subsequent electrical stimulation pulse sequences, when the electrical stimulation intensity maintained in the intensity maintenance phase T12 is less than or equal to the initial intensity, the duration of the intensity increase 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 one of the intensity maintenance phase T12, intensity reduction phase T13, and rest period T2 can be 0.

[0059] Studies have shown that increasing the intensity of electrical stimulation at certain stages in an electrical stimulation pulse sequence may cause the intensity to exceed the patient's tolerance during the subsequent intensity maintenance stage (T12), leading to discomfort or tingling sensations and affecting the safety of electrical stimulation.

[0060] 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 are usually divided into intensity levels, and there can be dozens of adjustment levels. During electrical stimulation therapy, the intensity of 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 electrical stimulation at level 50 is insufficient, and increases the level to 55, and feels that the intensity of electrical stimulation at this level is tolerable, then the intensity maintenance phase T12 of the next electrical stimulation pulse sequence will maintain the intensity at level 55. However, during the pulse stimulation period T1, patients cannot clearly distinguish which stage they are currently in. If the patient performs an increase in electrical stimulation intensity during the increase of electrical stimulation intensity (in the intensity increase stage T11) or after the electrical stimulation intensity has begun to decrease (in the intensity decrease stage T13), they may misjudge their own tolerance level. If they cannot actually tolerate the intensity of 55, they will experience discomfort in the next electrical stimulation pulse sequence.

[0061] Specifically, if a patient increases the intensity level during the intensity increase phase (T11), the intensity of the electrical stimulation pulse sequence during the intensity maintenance phase (T12) will exceed the patient's tolerance. For example, if a patient mistakenly believes that the intensity has increased to level 50 when the electrical stimulation intensity reaches level 47, and increases it by 5 levels because they think the current intensity is insufficient, then according to the user's operation, the electrical stimulation device will maintain the intensity at level 55 during the intensity maintenance phase (T12) after the intensity reaches level 55, exceeding the patient's tolerance and causing problems such as stinging or burning.

[0062] If a patient increases the intensity level during the intensity reduction phase (T13), the intensity of the electrical stimulation in the maintenance phase (T12) of the next electrical stimulation pulse sequence will exceed the patient's tolerance. For example, if a patient mistakenly believes the intensity is still at level 50 when it drops to level 47 and increases it by 5 levels, the intensity may not increase normally under the originally set downward trend. Even if the system stops decreasing the intensity after receiving a user-issued intensity increase command and executes the increase command, the intensity can only be increased to level 52. If the patient subjectively feels that it is tolerable at this point, then the patient is actually tolerating level 52. However, since the patient cannot know the actual current 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 adjusted level 55 is used as the baseline intensity, exceeding the patient's actual tolerable level 52. Therefore, the patient will experience discomfort during the intensity maintenance phase (T12) of the next electrical stimulation pulse sequence.

[0063] To address the above problems, embodiments of the present invention provide a method for adjusting the intensity of electrical stimulation. 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:

[0064] S110, Obtain strength enhancement command.

[0065] The intensity increase command received by the electrical stimulation device can originate from the user. This command can be a specific increase in intensity, such as a required increase in current or voltage, or a required increase in intensity level, such as one or more levels. For example, the electrical stimulation device may include a human-machine interface (HMI) module, through which the user can send intensity increase commands to the control module within the device. The HMI module can be, for example, a button, knob, or touchscreen.

[0066] When the electrostimulation device is an integrated device, the human-machine interface module and the control module can be integrated, with the control module used to implement the adjustment method provided in this embodiment. When the electrostimulation device is a separate device comprising a user terminal component and a stimulation terminal component, the user terminal component is mainly used for interaction with the user, and the stimulation terminal component is mainly used for applying electrical stimulation to the user's skin or other tissues. The human-machine interface module can be located in the user terminal component and connected to the control module therein; the stimulation terminal component may include a stimulation module (as the control part of the stimulation terminal component) and electrodes (as the execution part of the stimulation terminal component), which can be integrated or separate. The control module and the stimulation module cooperate to implement the adjustment method provided in this embodiment, and the control module and the stimulation module can communicate with each other via wired or wireless means. Furthermore, regardless of whether the electrostimulation device is integrated or separate, it can have a display module to intuitively display information such as the electrostimulation intensity value, control commands, and device operating status. In a separate device, the display module can be located in either the user terminal component or the stimulation terminal component, preferably in the user terminal component, to facilitate the user's access to treatment information.

[0067] S120. Determine whether the acquisition time of the intensity enhancement instruction is in the intensity maintenance phase; if yes, execute S130; if no, execute S140.

[0068] Since the intensity maintenance phase represents the stage with the highest pulse amplitude and intensity in the electrical stimulation pulse sequence, the patient's tolerance to electrical stimulation during this phase can reliably characterize the patient's tolerance throughout the entire electrical stimulation pulse sequence. Therefore, when an intensity increase command is received during the intensity maintenance phase, it correctly represents the patient's intention; that is, the stimulation intensity of the current electrical stimulation pulse sequence is indeed too low for the patient, and an intensity increase can be performed. For example, this step can be achieved by directly determining whether the intensity increase command is received within the time interval between the start and end of the intensity maintenance phase, or by determining whether the pulse intensity of the pulse at the time of acquisition is the same as the pulse intensity corresponding to the intensity maintenance phase. The specific determination method can be set according to the actual situation.

[0069] S130. Increase the intensity of electrical stimulation according to the intensity increase command. The determination of the maximum electrical stimulation intensity during the intensity maintenance phase is based on the intensity increase command, the time of acquisition of the intensity increase command, and the end time of the intensity maintenance phase.

[0070] Specifically, the interval between the acquisition of the intensity escalation command and the end of the intensity maintenance phase is defined as the remaining adjustment time, and the time required to escalate the electrical stimulation intensity to the target electrical stimulation intensity is defined as the intensity escalation demand time. Therefore, the maximum electrical stimulation intensity during the intensity maintenance phase includes the following two cases:

[0071] The first type involves a remaining adjustment time greater than or equal to the intensity enhancement requirement time. The enhancement of electrical stimulation intensity can be fully completed within the intensity maintenance phase, and the maximum electrical stimulation intensity is the target electrical stimulation intensity corresponding to the intensity enhancement command.

[0072] The second scenario is that the remaining adjustment time is less than the time required for intensity enhancement, and the enhancement of electrical stimulation intensity cannot be fully completed within the intensity maintenance phase. The maximum electrical stimulation intensity is the electrical stimulation intensity reached from the moment the intensity enhancement is performed until the end of the intensity maintenance phase.

[0073] In other words, the maximum intensity limit can also be understood as a limit on the duration of the increase in electrical stimulation intensity. That is, if the remaining adjustment time is sufficient, the intensity adjustment based on the intensity increase command can be completed. If the remaining adjustment time is insufficient, the intensity increase will continue until the intensity maintenance phase ends.

[0074] S140, Do not increase the intensity of electrical stimulation.

[0075] Specifically, if the current intensity increase command is not acquired within any electrical stimulation pulse sequence, and it is determined that an intensity increase based on that command will not be executed, the command can be discarded directly, or the user can be notified through text display or other means that the current state (stage) is where intensity increases are not permitted. Furthermore, other intensity adjustment commands can be acquired subsequently, and corresponding responses can be made based on these commands.

[0076] In the electrical stimulation intensity adjustment method provided by this invention, the increase in electrical stimulation intensity is controlled to occur during the intensity maintenance phase. This ensures that the intensity increase is based on the maximum electrical stimulation intensity of the current electrical stimulation pulse sequence, avoiding the problem of the electrical stimulation intensity exceeding the patient's tolerance during the subsequent intensity maintenance phase, which would occur if the intensity increase were performed during other intensity change phases. This ensures the safety of electrical stimulation intensity adjustment. Furthermore, this invention controls the intensity increase to end no later than the end of the intensity maintenance phase. This allows for the maximum possible increase in electrical stimulation intensity even when the remaining adjustment time in the intensity maintenance phase is insufficient. It also avoids conflicts between the intensity increase and the subsequent intensity reduction phase, and avoids the impact on the duration of the current intensity maintenance phase that might occur while waiting for the intensity increase to complete. This, in turn, avoids affecting the timing of subsequent treatment processes and improves the reliability of intensity adjustment. Therefore, compared to the prior art, this invention can improve the safety and reliability of electrical stimulation intensity increase.

[0077] Based on the above embodiments, optionally, the electrical stimulation intensity output by the electrical stimulation device is divided into levels, and the initial intensity of the intensity maintenance phase can be the electrical stimulation intensity corresponding to the initial level. The intensity increase command can be an "increase by 1 level" command, and correspondingly, a "+" button (which can be a physical button or a virtual button) can be provided in the electrical stimulation device.

[0078] Alternatively, the intensity increase command can be an "+N" level command, where N is an integer greater than or equal to 2. Correspondingly, a "+N" button can be provided in the electrical stimulation device. This design, compared to the cumbersome process of increasing electrical stimulation intensity only by repeatedly pressing the "+" button, effectively simplifies the user's operation and improves the user experience when the user has a significant need for increased intensity. When the intensity increase command is an "+N" level command, the increase can be controlled to proceed in steps, increasing only a portion of the N levels at each step to avoid the potential harm to the patient caused by a direct, stepwise increase in stimulation intensity across N levels. The number of levels increased in each step can be the same or different.

[0079] Specifically, when the intensity increase command is an "N-level increase" command, increasing the electrical stimulation intensity according to the intensity increase command may include: splitting the "N-level increase" command into multiple "M-level increase" commands, and repeatedly executing the "M-level increase" commands before the end condition for the increase is met, where 1 ≤ M < N. Here, N can be an integer multiple of M. The end condition for the increase is: completing the "N-level increase" command before the end of the intensity maintenance phase, or the electrical stimulation intensity increase has continued until the end of the intensity maintenance phase.

[0080] Based on the above implementation methods, there are several optional ways to execute the M-file command, some of which will be described below.

[0081] In one embodiment, optionally, executing the M-level adjustment command includes: before executing the M-level adjustment command, determining whether the current moment is in the intensity maintenance phase; if so, increasing the electrical stimulation intensity according to the M-level adjustment command; wherein, if the time interval between the current moment and the end moment of the intensity maintenance phase meets the duration requirement of the M-level adjustment, the M-level adjustment is completed; if the time interval between the current moment and the end moment of the intensity maintenance phase does not meet the duration requirement of the M-level adjustment, increasing the electrical stimulation intensity according to the M-level adjustment command until the end moment of the intensity maintenance phase; if not, stopping the increase in electrical stimulation intensity.

[0082] In this embodiment, when it is determined that the current moment is in the intensity maintenance phase, the M level adjustment is performed, which can meet the user's level adjustment needs as much as possible and increase the intensity of electrical stimulation as much as possible.

[0083] In another implementation, optionally, executing the M-level increase command includes: before executing the M-level increase command, determining whether the M-level increase adjustment can be completed before the end of the intensity maintenance phase; if so, then executing the M-level increase adjustment according to the M-level increase command; if not, then stopping the increase of the electrical stimulation intensity level.

[0084] In this embodiment, the adjustment of the M-level is only performed when it is determined that the adjustment can be completed before the end of the intensity maintenance phase. This ensures that the adjustment of the M-level is completed within the intensity maintenance phase and avoids the situation where the final level cannot be determined when the adjustment of the M-level ends during the enhancement process, and the user's tolerance level and the base level of the next electrical stimulation pulse sequence cannot be clearly defined. This ensures the safety and accuracy of the electrical stimulation intensity adjustment.

[0085] Based on the above embodiments, optionally, the adjustment process of adding M levels is performed step by step, or M=1, and the instruction to add M levels is an instruction to add 1 level. This setting is equivalent to the electrical stimulation device automatically controlling the electrical stimulation intensity level to increase step by step according to the instruction to add N levels. Specifically, after the user presses the "+N" button, the electrical stimulation output will automatically increase step by step. For example, when pressing "+5", the actual perception is that the user only pressed the adjustment button once, but the electrical stimulation output continuously executes +1 levels 5 times. The advantage of this setting is that the patient does not need to laboriously perform multiple level button operations, which can effectively reduce the time spent by the electrical stimulation device on signal acquisition, analysis, and internal transmission interaction, thereby reducing the electrical stimulation adjustment time. Furthermore, by using this automatic step-by-step adjustment method with a transitional form to increase the electrical stimulation intensity, it can ensure that the increase in electrical stimulation intensity meets the requirements of national standards, while minimizing discomfort caused to the patient by abrupt increases in electrical stimulation intensity. The specific national standard may be the following standard specified in "YY 0607-2007 - Medical Electrical Equipment - Part 2: Safety of Nerve and Muscle Stimulators": The device must be equipped with an output amplitude controller that allows the stimulator's output amplitude to be continuously adjustable from minimum to maximum, or intermittently adjustable in increments of no more than 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 briefly and then restored.

[0086] In summary, this embodiment limits the timing of each increment to N levels to ensure that the increment operation occurs during the intensity maintenance phase. Furthermore, for schemes that determine whether to increase intensity based on whether the current moment falls within the intensity maintenance phase—that is, schemes where increments can continue as long as the phase time limit is not exceeded—when M=1 is used, compared to setting M=2 or a larger value, the time required for incrementing by one level is shorter. As long as the increment begins near the end of the intensity maintenance phase, it can essentially be completed. Even if it cannot be completed, the final electrical stimulation intensity is not significantly different from the target intensity after incrementing by one level, allowing the final level to be determined as the level after incrementing by one level, thereby improving the accuracy and reliability of the scheme.

[0087] The above embodiments exemplify the process by which an electrical stimulation device automatically increases intensity level step by step according to an "N-level" command. However, for cases where the "N-level" command corresponds to a large intensity increase, such as 10 levels or more, the target intensity level of the electrical stimulation may have exceeded the user's tolerance threshold. To address this issue, the inventors have added a pause mechanism to the above embodiments to promptly stop the further increase in intensity in case of abnormal conditions. This pause mechanism is described in detail below.

[0088] Based on the above embodiments, the electrical stimulation intensity adjustment method may optionally further include: obtaining a pause command; stopping the increase of electrical stimulation intensity according to the pause command, and maintaining the current electrical stimulation intensity for electrical stimulation.

[0089] The pause command can be issued by the user to the electrical stimulation device and received by the control module. For example, a pause button (either a physical or virtual button) can be set in the human-computer interaction module. When the user feels discomfort, they can press the pause button to provide a pause command to the control module. Alternatively, the pause command can also be automatically generated by the control module when it determines that the electrical stimulation intensity is too high after receiving feedback signals from the user's skin or other tissues.

[0090] For example, there are several forms of adjustment procedures after the electrical stimulation intensity stops increasing. These include maintaining the current intensity until the intensity maintenance phase ends, until another intensity adjustment signal is received, or continuing the paused intensity increase command. For instance, consider an initial intensity of level 50 during the intensity maintenance phase, an intensity increase command of "increase by 5 levels," and a pause after reaching level 53. If no control signal is received after the pause, level 53 can be maintained until the intensity maintenance phase ends. If another intensity adjustment signal is received after the pause, such as "increase by 1 level," "increase by multiple levels," "decrease by 1 level," or "decrease 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 previous "increase by 5 levels" command can be executed again, increasing the electrical stimulation intensity from level 53 to level 55.

[0091] This embodiment is configured in this way to effectively improve the controllability and flexibility of the adjustment method.

[0092] Based on the above embodiments, optionally, if time permits, the intensity enhancement command can be acquired and executed multiple times during the intensity maintenance phase, and the number of executions is not limited here.

[0093] 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 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.

[0094] To simplify the method of adjusting electrical stimulation intensity and avoid the complex process of individually increasing the intensity and testing tolerance for multiple electrical stimulation pulse sequences within a sequence combination, an intensity increase can be implemented after receiving the intensity increase command. This occurs when the highest-intensity electrical stimulation pulse sequence in the current sequence combination arrives, and the intensity is increased according to the command during its intensity maintenance phase. If the patient still tolerates the adjusted intensity after the increase, it can be assumed that the patient will also tolerate the increased intensity of other electrical stimulation pulse sequences in the same sequence combination. Therefore, when the sequence combination is run again, the increased intensity can be directly applied to each electrical stimulation pulse sequence within that combination. Furthermore, after receiving the intensity increase command, the command can be executed during the intensity maintenance phase of the highest-intensity electrical stimulation pulse sequence in the current sequence combination, further simplifying the adjustment process, reducing the number of adjustments to the electrical stimulation pulse sequences, significantly shortening the adjustment time, and enabling faster execution of the treatment plan, thus improving efficiency.

[0095] The following description, using the structure of the electrical stimulation device and taking M=1 as an example, illustrates the specific implementation of the adjustment method provided in the embodiments of the present invention, but this is not intended to limit the present invention.

[0096] In one embodiment, the electrical stimulation device is optionally an integrated device that integrates a display module and a control module. The control module is used to execute the electrical stimulation intensity adjustment method provided in any of the above embodiments. The electrodes in the device apply electrical stimulation to the patient under the control of the control module, and the display module is used to display electrical stimulation-related information under the control of the control module.

[0097] Figure 5 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 5 In one embodiment, optionally, the electrical stimulation device includes a user terminal component 10 and a stimulation terminal component 20 with separate communication connections. The user terminal component 10 is used to acquire an N-level increment command SupN. Specifically, executing the N-level increment command can be as follows: the user terminal component 10 splits the N-level increment command SupN into multiple 1-level increment commands Sup1, and before the end condition for the increment is met, repeatedly sends the 1-level increment commands Sup1 to the stimulation terminal component 20, causing the stimulation terminal component 20 to execute the 1-level increment commands Sup1, thereby achieving automatic incremental increase of electrical stimulation intensity according to the N-level increment command SupN. For example, during the automatic incremental increase process, the user can pause the increment at any time, and since the intensity increase process may end prematurely due to the end of the intensity maintenance phase, the number of times the user terminal component 10 cyclically transmits the 1-level increment commands Sup1, R, is less than or equal to N.

[0098] Specifically, such as Figure 6As shown, the user terminal component 10 may include a control module 110 for receiving and splitting an N-level increase command (SupN). The stimulation terminal component 20 may include a stimulation module 210 and an electrode 220. The stimulation module 210 receives a 1-level increase command (Sup1), processes it into a stimulation signal, and transmits it to the electrode 220, causing the electrode 220 to apply the increased electrical stimulation to the patient. For example, the user terminal component 10 may be a computer or a portable device such as a mobile phone. The stimulation terminal component 20 may be an electrode bar integrating the stimulation module 210, or a separately configured device host (including the stimulation module 210) and electrode 220.

[0099] The above embodiments exemplify a scheme for the user terminal component 10 to split the N-level increment command, but this is not intended to limit the present invention. In other embodiments, alternatively, the user terminal component 10 may directly send the N-level increment command SupN to the stimulation terminal component 20, and the stimulation terminal component 20 may split the N-level increment command SupN into multiple 1-level increment commands Sup1, and repeatedly execute the 1-level increment command Sup1 before the end condition of the increment is met. The following is a detailed description of this scheme.

[0100] 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 Specifically, executing the "increase N levels" command can be as follows: the control module 110 receives the "increase N levels" command SupN issued by the user and directly sends it to the stimulation module 210; the stimulation module 210 breaks down the "increase N levels" command SupN into multiple "increase 1 levels" commands Sup1, and before the end of the increment condition is met, repeatedly processes the "increase 1 level" commands Sup1 into stimulation signals, causing the electrode 220 to apply the increased electrical stimulation to the patient. In this way, the electrical stimulation intensity can be automatically increased step-by-step according to the "increase N levels" command SupN. For example, during the automatic step-by-step increase process, the user can pause the increment at any time, and since the intensity increase process may end prematurely due to the end of the intensity maintenance phase, the number of times the stimulation module 210 executes the "increase 1 level" command Sup1 is less than or equal to N.

[0101] See also Figure 6 and Figure 7Based on the above embodiments, optionally, the stimulation end component 20 can transmit a synchronization signal Ssyn to the user end component 10. The synchronization signal Ssyn may contain electrical stimulation intensity information so that the user end component 10 can obtain the current electrical stimulation intensity. Specifically, after the stimulation end component 20 completes each k-level adjustment, it feeds back the electrical stimulation intensity information to the control module 110 through the stimulation module 210, where 1 ≤ k ≤ N. For example, k = 1 to ensure the timeliness of the feedback information; or k = N to avoid frequent information interaction between the control module 110 and the stimulation module 210. Alternatively, the control module 110 may obtain the electrical stimulation intensity information from the stimulation module 210 at preset time intervals to achieve timed acquisition of the electrical stimulation intensity.

[0102] See also Figure 6 and Figure 7 Based on the above embodiments, optionally, the display module 120 in the electrical stimulation device is disposed in the user terminal component 10 or the stimulation terminal component 20; here, it is described as being disposed in the user terminal component 10. The display module 120 is communicatively connected to the control module 110. The control module 110 can control the display module 120 to display the electrical stimulation intensity value and other device operation-related information, such as the current electrical stimulation pulse sequence information (which may include pulse frequency, pulse width, pulse energy, etc.), so as to make the adjustment process more intuitive.

[0103] Taking the display module 120 displaying the electrical stimulation intensity value as an example, the specific method by which the control module 110 controls the display can be: according to the intensity increase command, the control module 110 controls the display module to refresh the electrical stimulation intensity value according to the intensity level increase frequency. That is, after receiving the increase N level command SupN, the control module 110 can, without waiting for the synchronization signal Ssyn from the stimulation module 210, directly control the display module 120 to refresh the display interface in a level-by-level manner according to the preset increase time and frequency, achieving pseudo-synchronization between the display process and the control process; and after receiving the synchronization signal Ssyn from the stimulation module 210, adjust the information in the display interface accordingly to achieve actual synchronization between the display process and the control process. Alternatively, when the control module 110 receives the electrical stimulation intensity information transmitted by the stimulation module 210, it can control the display module 120 to refresh the electrical stimulation intensity value according to the electrical stimulation intensity information, directly achieving synchronization between the display process and the control process.

[0104] 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.

[0105] Alternatively, at least two intensity levels can be configured with different adjustment durations. For example, the adjustment duration for each intensity level can be set to decrease progressively with each increase in intensity. This means the increase in intensity can proceed gradually from slow to fast, reducing the total adjustment time while ensuring smooth adjustment and increasing the probability of completing the intensity increase during the maintenance phase, thus meeting the user's intensity increase needs as much as possible. The reduction in adjustment duration for each intensity level can be the same to achieve a linear decrease, such as setting it to 0.6 seconds for increasing one intensity level, 0.5 seconds for the next, 0.4 seconds for the next, and so on. Alternatively, the reduction in adjustment duration for each intensity level can be different to achieve a non-linear decrease, such as setting it to 0.6 seconds for increasing one intensity level, 0.55 seconds for the next, 0.48 seconds for the next, and so on.

[0106] 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 be a process of uniformly changing the adjustment amount.

[0107] 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.

[0108] 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.

[0109] 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).

[0110] The adjustment method will be described below through specific embodiments.

[0111] For example, increasing the intensity by N takes 2 seconds, and a total of 4 increases in intensity are required. At the end of each increase in intensity, the stimulation module or control module determines whether the current intensity is maintained.

[0112] For example: the total duration of shifting to N gear is 2 seconds, the intensity maintenance phase is set to 10 seconds, shifting gears can be performed at the 9th second, shifting to the gear value at the 10th second or less, and the current shifting ends immediately when the 10th second is over.

[0113] For example, if the remaining seconds of the intensity maintenance phase and the gear adjustment time do not meet the matching requirements, the gear increase will stop at the nearest maximum allowable gear increase. For instance, if the total duration of increasing to gear N is 2 seconds, including 4 gears, and each gear increase takes 0.5 seconds, and the intensity maintenance phase is set to 10 seconds, and the gear increase operation is performed at 8.7 seconds, then theoretically, after increasing two gears, it will take 9.7 seconds. Increasing a third gear would exceed 10 seconds. At this point, the third gear increase can be stopped at 9.7 seconds, and the gear increase will stop until the intensity reduction phase begins after 10 seconds.

[0114] In summary, the electrical stimulation intensity adjustment method provided by the embodiments of the present invention can ensure that the intensity enhancement adjustment is performed during the intensity maintenance phase of the electrical stimulation pulse sequence and is forcibly terminated at the end of the intensity maintenance phase, thus ensuring the safety and reliability of the adjustment process.

[0115] 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 8 This is a schematic diagram of the structure of an electrical stimulation device provided in an embodiment of the present invention. See also... Figure 8 For example, the electrical stimulation device includes a user terminal component 10 and a stimulation terminal component 20. The user terminal component 10 may include a control module 110 and a display module 120, and the stimulation terminal component 20 may include a stimulation module 210 and an electrode 220.

[0116] It should be noted that in the various embodiments of the electrical stimulation intensity adjustment method, specific descriptions have been made for electrical stimulation devices with different structures. These device structures can all be considered as the configuration of the electrical stimulation device provided in the embodiments of the present invention, and repeated content will not be described here.

[0117] 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.

[0118] 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 an electrical stimulation device, the electrical stimulation pulse sequence during the application of electrical stimulation by the device includes an intensity increase phase and an intensity maintenance phase; The method for adjusting the intensity of electrical stimulation includes: Obtain an intensity boost instruction and determine whether the intensity boost instruction is obtained during the intensity maintenance phase; If so, the electrical stimulation intensity is increased according to the intensity increase command, wherein the determination of the maximum electrical stimulation intensity during the intensity maintenance phase includes: the intensity increase command, the time of acquisition of the intensity increase command, and the end time of the intensity maintenance phase; When the remaining adjustment time of the intensity maintenance phase is greater than or equal to the intensity increase requirement time, the maximum electrical stimulation intensity is the target electrical stimulation intensity corresponding to the intensity increase command; wherein, the remaining adjustment time is the interval between the acquisition time of the intensity increase command and the end time of the intensity maintenance phase, and the intensity increase requirement time is the time required to increase the electrical stimulation intensity to the target electrical stimulation intensity; When the remaining adjustment time is less than the intensity increase requirement time, the maximum electrical stimulation intensity is the electrical stimulation intensity reached until the end of the intensity maintenance phase.

2. The method for adjusting the intensity of electrical stimulation according to claim 1, characterized in that, The intensity increase instruction is an N-level increase instruction, where N is an integer greater than or equal to 2; The step of increasing the intensity of electrical stimulation according to the intensity increase command includes: The upshift N command is split into multiple upshift M commands, and the upshift M command is repeatedly executed before the upshift end condition is met, where 1 ≤ M < N; The conditions for ending the intensity increase are: the N-level increase command is completed before the end of the intensity maintenance phase, or the increase in electrical stimulation intensity has continued until the end of the intensity maintenance phase.

3. The method for adjusting the intensity of electrical stimulation according to claim 2, characterized in that, Executing the command to add M mode includes: Before executing the M-gear command, determine whether the current moment is in the intensity maintenance phase; If so, the electrical stimulation intensity is increased according to the M-level instruction; wherein, if the time interval between the current moment and the end moment of the intensity maintenance phase meets the duration requirement of the M-level adjustment, the M-level adjustment is completed; if the time interval between the current moment and the end moment of the intensity maintenance phase does not meet the duration requirement of the M-level adjustment, the electrical stimulation intensity is increased according to the M-level instruction until the end moment of the intensity maintenance phase. If not, then stop increasing the intensity of electrical stimulation.

4. The method for adjusting the intensity of electrical stimulation according to claim 2, characterized in that, Executing the command to add M mode includes: Before executing the M-gear adjustment command, it is determined whether the M-gear adjustment can be completed before the end of the intensity maintenance phase; If so, then adjust to M mode according to the M mode adjustment command. If not, then stop increasing the intensity of the electrical stimulation.

5. The method for adjusting the intensity of electrical stimulation according to claim 2, characterized in that, The electrical stimulation device includes a user terminal component and a stimulation terminal component connected in communication; the user terminal component is used to acquire the N-level increase command. The upshift command is broken down into multiple upshift commands (M gear commands), and the upshift command (M gear command) is repeatedly executed before the upshift end condition is met, including: The user terminal component splits the "add N" instruction into multiple "add M" instructions, and before the upgrade end condition is met, repeatedly sends the "add M" instructions to the stimulation terminal component, causing the stimulation terminal component to execute the "add M" instructions.

6. The method for adjusting the intensity of electrical stimulation according to claim 2, characterized in that, The electrical stimulation device includes a user terminal component and a stimulation terminal component connected in communication, wherein the user terminal component is used to acquire the N-level increase command; The upshift command is broken down into multiple upshift commands (M gear commands), and the upshift command (M gear command) is repeatedly executed before the upshift end condition is met, including: The user terminal component sends the N-level increase command to the stimulation terminal component; The stimulation end component splits the N-level increase command into multiple M-level increase commands, and repeatedly executes the M-level increase command before the level increase end condition is met.

7. The method for adjusting the intensity of electrical stimulation according to any one of claims 5-6, characterized in that, After each k-level adjustment, the stimulation terminal component feeds back electrical stimulation intensity information to the user terminal component, where 1≤k≤N; Alternatively, the user terminal component may acquire electrical stimulation intensity information from the stimulation terminal component at preset time intervals.

8. The method for adjusting the intensity of electrical stimulation according to claim 7, characterized in that, The user terminal component includes a control module for acquiring the N-level increase command and receiving the electrical stimulation intensity information; The electrical stimulation device further includes: a display module, disposed in the user terminal component or the stimulation terminal component; The method for adjusting the intensity of electrical stimulation also includes: The control module controls the display module to display the electrical stimulation intensity value; Specifically, the control module controls the display module to refresh the electrical stimulation intensity value according to the frequency of increasing the electrical stimulation intensity level based on the N-level increase instruction; or, when the control module receives the electrical stimulation intensity information, it controls the display module to refresh the electrical stimulation intensity value based on the electrical stimulation intensity information.

9. The method for adjusting the intensity of electrical stimulation according to any one of claims 2-6, characterized in that, When M=1, the instruction to add M gear is the instruction to add 1 gear.

10. The method for adjusting the intensity of electrical stimulation according to claim 1, characterized in that, Also includes: Get the pause command; The electrical stimulation intensity is stopped from increasing according to the pause command, and the current electrical stimulation intensity is maintained for electrical stimulation.

11. An electrical stimulation device, characterized in that, Used to perform the electrical stimulation intensity adjustment method according to any one of claims 1-10.

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