Method of electrical stimulation intensity adjustment and electrical stimulation device

Abstract

The application discloses an electric stimulation intensity adjusting method and an electric stimulation device. The electric stimulation intensity adjusting method is applied to the electric stimulation device. During electric stimulation application of the electric stimulation device, an electric stimulation pulse sequence comprises an intensity maintaining stage and an intensity decreasing stage. The electric stimulation intensity adjusting method comprises the following steps: obtaining a gear-up instruction; when a time point of obtaining the gear-up instruction is located in the intensity maintaining stage, performing gear-up of electric stimulation intensity according to the gear-up instruction, and judging whether the gear-up can be completed before the intensity maintaining stage ends; if yes, entering the intensity decreasing stage at the end of the intensity maintaining stage; if no, entering the intensity decreasing stage at the completion of the gear-up. The embodiment of the application can improve safety and reliability of electric stimulation intensity promotion.

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 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 stimulation pulses. These sequences may include an intensity increase phase, an intensity hold phase, an intensity decrease phase, and a rest period. The next sequence begins after the previous one is completed, and any intensity adjustments made in the previous sequence are remembered and carried over to the next. Improper timing of intensity increases can lead to the intensity during the hold phase exceeding the patient's tolerance. For example, increasing the intensity during the intensity increase phase of the current sequence may result in an intensity exceeding the patient's tolerance during the hold phase. Similarly, increasing the intensity during the intensity decrease phase may lead to an intensity exceeding the patient's tolerance during the hold phase of the next sequence. Furthermore, increasing the intensity at the beginning or continuing into the intensity decrease phase can cause a conflict between simultaneous intensity increases and decreases, leading to control confusion and affecting the reliability of intensity adjustment. Existing technologies typically neglect the timing of adjusting the intensity of electrical stimulation, making it difficult to guarantee the safety and reliability of increasing the intensity of electrical stimulation. 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 the electrical stimulation pulse sequence includes an intensity maintenance phase and an intensity decrease phase;

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

[0007] Get the upshift command;

[0008] When the acquisition time of the upshift command is within the intensity maintenance phase, the intensity of electrical stimulation is increased according to the upshift command, and it is determined whether the upshift can be completed before the end of the intensity maintenance phase.

[0009] If so, then the intensity decrease phase begins at the end of the intensity holding phase;

[0010] If not, the intensity reduction phase will begin when the gear shift is completed.

[0011] Optionally, determining whether the gear shift can be completed before the end of the intensity maintenance phase includes:

[0012] The remaining time of the intensity holding phase is determined based on the acquisition time of the upshift command and the end time of the intensity holding phase;

[0013] The target gear is determined based on the upshift command and the current gear, and the adjustment time required to shift from the current gear to the target gear is determined.

[0014] Determine whether the adjustment time is greater than the remaining time;

[0015] If so, the gear shift cannot be completed before the end of the intensity maintenance phase;

[0016] If not, the gear shift can be completed before the end of the intensity maintenance phase.

[0017] Optionally, the upshift command is an upshift command for N gears, where N is an integer greater than 1;

[0018] Increasing the intensity of electrical stimulation according to the aforementioned increase command includes:

[0019] The electrical stimulation intensity is increased step by step from the current level until the target level corresponding to the N-level command is reached.

[0020] Optionally, the electrical stimulation intensity is increased step by step from the current level until the target level corresponding to the N-level increase command is reached, including:

[0021] The upshift command is broken down into multiple upshift commands, and the upshift commands are repeatedly executed before the target gear is reached.

[0022] Optionally, the electrical stimulation device includes a control device and a stimulation device; the control device is used to acquire the N-level increase command;

[0023] The step of decomposing the upshift command into multiple upshift commands and repeatedly executing the upshift commands before reaching the target gear includes:

[0024] The control device decomposes the "increase N" command into multiple "increase 1" commands, and before reaching the target level, repeatedly sends the "increase 1" commands to the stimulation device, causing the stimulation device to execute the "increase 1" commands.

[0025] Optionally, the electrical stimulation device includes a control device and a stimulation device; the control device is used to acquire the N-level increase command;

[0026] The step of decomposing the upshift command into multiple upshift commands and repeatedly executing the upshift commands before reaching the target gear includes:

[0027] The control device sends the N-level increase command to the stimulation device;

[0028] The stimulation device decomposes the "increase N" command into multiple "increase 1" commands, and repeatedly executes the "increase 1" command before reaching the target level.

[0029] Optionally, the adjustment time is the same for each gear.

[0030] Alternatively, as the number of gears increases, the adjustment time for each gear decreases progressively.

[0031] Optionally, the electrical stimulation intensity adjustment amount is the same for each gear level;

[0032] Alternatively, as the number of gears increases, the intensity of electrical stimulation corresponding to each gear decreases progressively.

[0033] Alternatively, as the number of gears increases, the intensity of electrical stimulation corresponding to each gear level increases progressively.

[0034] Optionally, the method for adjusting the intensity of electrical stimulation further includes:

[0035] Get the command to pause upshifting;

[0036] According to the pause and increase command, the increase in electrical stimulation intensity is stopped, and the current intensity is maintained for electrical stimulation.

[0037] Optionally, the method for adjusting the intensity of electrical stimulation further includes:

[0038] The display in the electrical stimulation device is controlled to show the current setting and / or the operating information of the current electrical stimulation pulse sequence.

[0039] 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.

[0040] In the electrical stimulation intensity adjustment method provided by this invention, controlling the increase in intensity of the electrical stimulation device during the intensity maintenance phase ensures that the intensity increase is based on the maximum electrical stimulation intensity of the current electrical stimulation pulse sequence. This avoids 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, thus ensuring the safety of electrical stimulation intensity adjustment. Furthermore, if the intensity increase operation exceeds the time limit of the intensity maintenance phase, this invention waits until the intensity increase is complete before entering the intensity decrease phase. This is equivalent to delaying the start time of the intensity decrease phase based on the intensity increase adjustment time when the remaining time in the intensity maintenance phase is insufficient, thereby completing the intensity increase of the electrical stimulation device and avoiding conflicts between the intensity increase and the subsequent intensity decrease phase, improving the reliability of intensity adjustment. Therefore, compared to the prior art, this invention can improve the safety and reliability of electrical stimulation intensity increase.

[0041] 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

[0042] 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.

[0043] Figure 1 This is a schematic diagram of the treatment process of an electrical stimulation device provided in an embodiment of the present invention;

[0044] Figure 2 This is a pulse diagram illustrating the treatment process of an electrical stimulation device provided in an embodiment of the present invention;

[0045] Figure 3 This is a schematic diagram of an electrical stimulation pulse sequence provided in an embodiment of the present invention;

[0046] Figure 4 This is a schematic flowchart of an electrical stimulation intensity adjustment method provided in an embodiment of the present invention;

[0047] 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;

[0048] 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;

[0049] 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;

[0050] 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

[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 a non-exclusive inclusion; for example, a process, method, system, product, or apparatus that comprises a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to such processes, methods, products, or apparatus.

[0053] This invention provides a method for adjusting the intensity of electrical stimulation, applicable to applications requiring increased intensity levels from electrical stimulation devices. During the application of electrical stimulation, the method increases the intensity during a hold phase based on the user's desired level, and then decreases the intensity after the increase is complete, 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 a controller within the integrated device; alternatively, the device can be a separate unit comprising a control device and a stimulation device, with the adjustment method implemented by the control device and the stimulation device working together. Specific implementation details are described below, and configurations can be tailored to specific needs in practical applications.

[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 1This 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.

[0056] For the specific composition of the electrical stimulation pulse sequence, please refer to Figure 3 For 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. During 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 level at the start of treatment, ensuring the safety of the treatment process. If the electrical stimulation intensity remains within the patient's tolerance range until the intensity maintenance phase T12 ends, it can be determined that the patient tolerates the initial intensity level. Therefore, in subsequent electrical stimulation pulse sequences, when the intensity level maintained in the intensity maintenance phase T12 is less than or equal to the initial intensity level, 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 decrease phase T13, and rest period T2 can be 0.

[0057] Studies have shown that increasing the intensity at certain stages of an electrical stimulation pulse sequence may cause the stimulation intensity to exceed the patient's tolerance during the subsequent 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 level 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 level 50 is insufficient and increases the level to 55, and finds the intensity tolerable at that level, 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 actually distinguish which stage they are 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.

[0059] Specifically, if a patient increases the intensity level during the intensity-increasing phase (T11), the intensity of the electrical stimulation pulse sequence during the intensity-maintaining 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 intensity-maintaining phase (T12) after reaching level 55, exceeding the patient's tolerance and causing problems such as stinging or burning.

[0060] If a patient increases the intensity level during the intensity reduction phase (T13), the intensity of the electrical stimulation in the 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 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 setting stops decreasing the intensity after receiving a user-issued 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.

[0061] 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:

[0062] S110, Obtain the shift command.

[0063] The intensity increase command received by the electrical stimulation device can come from the user, who can set the intensity increase value according to their needs, such as increasing by one or more levels. For example, the electrical stimulation device may include a human-machine interface module, through which the user can send intensity increase commands to the controller within the device. The human-machine interface module may be, for example, a button, knob, or touchscreen.

[0064] When the electrostimulation device is an integrated device, the human-machine interface module and the controller can be integrated, with the controller used to implement the adjustment method provided in this embodiment. When the electrostimulation device is a separate device comprising a control device and a stimulation device, the control device is mainly used for interaction with the user, and the stimulation device 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 control device and connected to the controller within the control device; the stimulation device may include a stimulator (as the control part of the stimulation device) and an electrode (as the execution part of the stimulation device), which can be integrated or separate. The controller and the stimulator cooperate to implement the adjustment method provided in this embodiment, and the controller and the stimulator 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 to visually display information such as the electrical stimulation intensity value, control commands, and device operating status. In separate devices, the display can be located in the control device or the stimulation device, preferably in the control device, to facilitate the user's access to treatment information.

[0065] S120. When the upshift command is received during the intensity maintenance phase, the intensity of the electrical stimulation is increased according to the upshift command.

[0066] Since the intensity maintenance phase represents the stage with the highest pulse amplitude and intensity (i.e., the highest level) 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 increase in intensity is received during the intensity maintenance phase, it can accurately represent the patient's intention; that is, the current level of the electrical stimulation pulse sequence is indeed too low for the patient, and the intensity can be increased.

[0067] S130: Determine whether the gear shift can be completed before the end of the intensity maintenance phase; if yes, execute S140; if no, execute S150.

[0068] In this embodiment, when the electrical stimulation device actually performs a level-up operation, it requires a certain amount of time to increase the level from the current level (i.e., the initial level of the pulse hold phase) to the target level corresponding to the level-up command. Furthermore, both the controller and the stimulator require a certain amount of response time to respond to the command, and the signal interaction between the controller and the stimulator also requires a certain amount of communication time. The adjustment time for level-up of the electrical stimulation device includes, but is not limited to, the various times listed above. However, in the electrical stimulation pulse sequence of the electrical stimulation device, the duration of the intensity hold phase is limited. In this embodiment, the level is increased when the level-up command is determined to be acquired during the intensity hold phase. Therefore, it is possible that when the electrical stimulation device performs a level-up operation, the adjustment time required for the level-up operation is greater than the remaining time of the intensity hold phase; that is, the remaining time of the intensity hold phase is insufficient to support the completion of the level-up operation.

[0069] Specifically, this step may involve: determining the remaining time of the intensity holding phase based on the acquisition time of the upshift command and the end time of the intensity holding phase; determining the target gear based on the upshift command and the current gear, and determining the adjustment time required to shift from the current gear to the target gear. For example, the interval between the acquisition time of the upshift command and the end time of the intensity holding phase is the remaining time, and the current gear plus the number of gears to be shifted corresponding to the upshift command is the target gear. If the adjustment time is greater than the remaining time, the gear shift cannot be completed before the end of the intensity holding phase; if the adjustment time is less than or equal to the remaining time, the gear shift can be completed before the end of the intensity holding phase.

[0070] S140, At the end of the strength holding phase, the strength decrease phase begins.

[0071] Specifically, the increase in electrical stimulation intensity can be completed entirely within the intensity maintenance phase without altering the original timing of the electrical stimulation pulse sequence, and the intensity can decrease at the end of the intensity maintenance phase. Furthermore, during or after the increase in electrical stimulation intensity, adjustment commands can be continuously acquired (e.g., acquiring another increase command or acquiring other adjustment commands), and corresponding responses can be made based on the acquired adjustment commands.

[0072] S150, The intensity decrease phase begins when the gear shift is completed.

[0073] In this case, the increase in electrical stimulation intensity cannot be completed within the intensity maintenance phase. It is necessary to adjust the original timing of the electrical stimulation pulse sequence and delay the start time of the intensity decrease phase. The delay time is the difference between the adjustment time and the remaining time.

[0074] In the electrical stimulation intensity adjustment method provided by this invention, controlling the increase in intensity of the electrical stimulation device during the intensity maintenance phase ensures that the intensity increase is based on the maximum electrical stimulation intensity of the current electrical stimulation pulse sequence. This avoids 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, thus ensuring the safety of electrical stimulation intensity adjustment. Furthermore, if the intensity increase operation exceeds the time limit of the intensity maintenance phase, this invention waits until the intensity increase is complete before entering the intensity decrease phase. This is equivalent to delaying the start time of the intensity decrease phase based on the intensity increase adjustment time when the remaining time in the intensity maintenance phase is insufficient, thereby completing the intensity increase of the electrical stimulation device and avoiding conflicts between the intensity increase and the subsequent intensity decrease phase, improving the reliability of intensity adjustment. Therefore, compared to the prior art, this invention can improve the safety and reliability of electrical stimulation intensity increase.

[0075] Based on the above embodiments, optionally, the increment command can be an increment of 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.

[0076] Alternatively, the intensity increase command can be an "+N" command, where N is an integer greater than 1. 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" command, the increase can be controlled to proceed in steps, increasing a portion of the N levels at each step, thus avoiding the harm to the patient caused by a direct, stepwise increase in electrical stimulation intensity across N levels.

[0077] The number of intensity levels increased at each step can be the same or different. Preferably, the intensity is increased incrementally from the current level until the target level corresponding to the "+N" level command is reached, thus minimizing abrupt increases in intensity. Specifically, after the user presses the "+N" button, the electrical stimulation output automatically increases in intensity levels incrementally. For example, when pressing "+5", the user perceives only one press of the adjustment button, but the electrical stimulation output continuously increases by 1 level 5 times. This design offers several advantages: patients do not need to perform multiple button presses, effectively reducing the time spent by the electrical stimulation device on signal acquisition, analysis, and internal transmission, thereby reducing the adjustment time. Furthermore, this automatic, incremental increase in intensity ensures that the intensity adjustment process meets national standards while minimizing discomfort caused by abrupt increases in 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.

[0078] For example, the specific implementation of increasing intensity by gear can be: decompose the N-gear increase instruction into multiple 1-gear increase instructions, and repeatedly execute the 1-gear increase instruction before reaching the target gear.

[0079] Based on the above embodiments, optionally, when the adjustment time is greater than the remaining time, the delay time required for the intensity decrease phase can be estimated in advance. Alternatively, before each execution of the increment command, it can be determined whether the current moment is in the intensity maintenance phase, and based on the time required for increment adjustment, it can be determined whether the start time of the intensity decrease phase should be delayed, and the specific delay time can be determined. By gradually determining the required delay time based on the adjustment time of each increment, the start time of the intensity decrease phase can be made more accurate.

[0080] Based on the above embodiments, the electrical stimulation intensity adjustment method may optionally further include: obtaining a pause-up command; stopping the increase of electrical stimulation intensity according to the pause-up command, and maintaining the current electrical stimulation intensity for electrical stimulation.

[0081] The pause / increase command can be issued by the user to the electrical stimulation device and received by the controller. 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 / increase command to the controller. Alternatively, the pause / increase command can also be automatically generated by the controller when it determines that the electrical stimulation intensity is too high after receiving feedback signals from the user's skin or other tissues.

[0082] 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 holding phase ends, until another level adjustment signal is received, or continuing the paused increase command. For instance, consider an initial intensity of level 50 during the intensity holding phase, an increase command of 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 holding phase ends. If another level adjustment signal is received after the pause, such as increasing by 1 level, increasing by more levels, decreasing by 1 level, or decreasing by more levels, the electrical stimulation intensity can be adjusted based on the received signal, building upon level 53. When the user presses the pause increase command again after the pause, the previous increase command of 5 levels can be resumed, completing the remaining 2 levels of increase, and the electrical stimulation intensity can be increased from level 53 to level 55.

[0083] This embodiment is configured in this way to effectively improve the controllability and flexibility of the adjustment method.

[0084] 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.

[0085] To simplify the method of adjusting electrical stimulation intensity and avoid the complex process of individually increasing the intensity level and testing tolerance for multiple electrical stimulation pulse sequences within a sequence combination, after receiving the increase instruction, the intensity can be increased according to the instruction during the intensity maintenance phase of the electrical stimulation pulse sequence with the highest intensity level in the current sequence combination after receiving the increase instruction. If the patient still tolerates the adjusted electrical stimulation intensity after the increase, it can be assumed that the patient will also tolerate it after increasing the intensity level of other electrical stimulation pulse sequences in the same sequence combination. Then, when the sequence combination is run again, the increased intensity level of each electrical stimulation pulse sequence in the sequence combination can be directly provided. Furthermore, after receiving the increase instruction, the instruction can be executed during the intensity maintenance phase of the electrical stimulation pulse sequence with the highest intensity level in the current stage combination after receiving the increase instruction, further simplifying the adjustment process, reducing the number of adjustments of the electrical stimulation pulse sequences, and thus significantly shortening the adjustment time, allowing the treatment plan to be executed faster and improving execution efficiency.

[0086] The following description, in conjunction with the structure of the electrical stimulation device, provides an exemplary illustration of 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.

[0087] In one embodiment, the electrical stimulation device is optionally an integrated device that integrates a display and a controller. The controller 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 controller, and the display is used to display electrical stimulation-related information under the control of the controller.

[0088] 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 control device 10 and a stimulation device 20 with separate communication connections. The control device 10 is used to acquire an N-level increment command SupN. Specifically, executing the N-level increment command can be as follows: the control device 10 decomposes the N-level increment command SupN into multiple 1-level increment commands Sup1, and before reaching the target level, repeatedly sends the 1-level increment commands Sup1 to the stimulation device 20, causing the stimulation device 20 to execute the 1-level increment commands Sup1, thereby automatically increasing the electrical stimulation intensity level step by step according to the N-level increment command SupN. For example, during the automatic step-by-step increase process, the user can pause the increase at any time; therefore, the number of times the control device 10 cyclically transmits the 1-level increment commands Sup1, M, is less than or equal to N.

[0089] Specifically, such as Figure 6As shown, the control device 10 may include a controller 110 for receiving and disassembling an N-level increase command (SupN). The stimulation device 20 may include a stimulator 210 and an electrode 220. The stimulator 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 control device 10 may be a computer or a portable device such as a mobile phone. The stimulation device 20 may be an electrode bar integrating the stimulator 210, or a separate device host (including the stimulator 210) and electrode 220.

[0090] The above embodiments exemplify a scheme for the control device 10 to split the N-level increment command, but this is not intended to limit the present invention. In other embodiments, optionally, the control device 10 may directly send the N-level increment command SupN to the stimulation device 20, and the stimulation device 20 may decompose the N-level increment command SupN into multiple 1-level increment commands Sup1, and repeatedly execute the 1-level increment command Sup1 before reaching the target level. The following is a detailed description of this scheme.

[0091] 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: Controller 110 receives the "increase N levels" command SupN issued by the user and directly sends it to stimulator 210; stimulator 210 decomposes the "increase N levels" command SupN into multiple "increase 1 levels" commands Sup1, and before reaching the target level, repeatedly processes the "increase 1 level" commands Sup1 into stimulation signals, causing 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 increase at any time, therefore the number of times stimulator 210 executes the "increase 1 level" command Sup1 repeatedly, M, is less than or equal to N.

[0092] It should be noted that the controller 110 or the stimulator 210 can use any decomposition method in the prior art to break down the N-level increase instruction SupN into a series of 1-level increase instructions Sup1. Alternatively, the N-level increase instruction SupN can be broken down into multiple sub-increase instructions, where the number of levels r corresponding to each sub-increase instruction is between 1 and N, and the number of levels corresponding to each sub-increase instruction can be the same or different. When r ≠ 1, the stimulator 210 still automatically increases the level step by step until the electrical stimulation intensity is increased to level r.

[0093] See also Figure 6 and Figure 7Based on the above embodiments, optionally, the stimulation device 20 can transmit a synchronization signal Sharyn to the control device 10. The synchronization signal Sharyn may contain electrical stimulation intensity information so that the control device 10 can obtain the current electrical stimulation intensity level. Specifically, after each k-level adjustment, the stimulation device 20 can feed back the electrical stimulation intensity information to the controller 110 through the stimulator 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 controller 110 and the stimulator 210. Alternatively, the controller 110 can send an inquiry signal to the stimulator 210 at preset intervals to obtain electrical stimulation intensity information from the stimulator 210, thereby achieving timed acquisition of electrical stimulation intensity.

[0094] See also Figure 6 and Figure 7 Based on the above embodiments, optionally, the display 120 in the electrical stimulation device is disposed in the control device 10 or the stimulation device 20; here, it is described as being disposed in the control device 10. The display 120 is communicatively connected to the controller 110. The controller 110 can control the display 120 to display the current setting and other device operation-related information, such as the operation information of the current electrical stimulation pulse sequence (which may include pulse frequency, pulse width, pulse energy, etc.), so as to make the adjustment process more intuitive.

[0095] Taking the display 120 showing the intensity level of electrical stimulation as an example, the controller 110 can control the display in the following ways: according to the increment command, the controller 110 controls the display 120 to refresh the intensity level of electrical stimulation according to the increment frequency of the intensity level. That is, after receiving the increment command SupN, the controller 110 can directly control the display 120 to refresh the display interface in a incrementing manner according to the preset increment time and frequency without waiting for the synchronization signal Ssyn from the stimulator 210, thus achieving pseudo-synchronization between the display process and the control process; and after receiving the synchronization signal Ssyn from the stimulator 210, it can adjust the information in the display interface accordingly to achieve actual synchronization between the display process and the control process. Alternatively, when the controller 110 receives the synchronization signal Ssyn transmitted by the stimulator 210, it can control the display 120 to refresh the intensity level of electrical stimulation according to the synchronization signal Ssyn, directly achieving synchronization between the display process and the control process.

[0096] 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.

[0097] Alternatively, at least two adjustment durations can be set to be different. For example, the adjustment duration for each adjustment level can be set to decrease progressively as the intensity increases. That is, the increase in intensity can be a gradual process from slow to fast, reducing the total adjustment time while ensuring the smoothness of the adjustment process, increasing the probability of completing the increase within the intensity maintenance phase, and minimizing the adjustment to the original timing of the electrical stimulation pulse sequence. The reduction in adjustment duration for each adjustment level can be the same to achieve a linear decrease in adjustment duration, for example, setting it to 0.6 seconds for increasing one level, 0.5 seconds for the next, 0.4 seconds for the next, and so on. Alternatively, the reduction in adjustment duration for each adjustment level can be different to achieve a non-linear decrease in adjustment duration, for example, setting it to 0.6 seconds for increasing one level, 0.55 seconds for the next, 0.48 seconds for the next, and so on.

[0098] Based on the above embodiments, optionally, the electrical stimulation intensity adjustment amount (or the electrical stimulation intensity increment from the previous level) corresponding to each level is the same, that is, the leveling process can be a process of uniformly changing adjustment amount.

[0099] 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.

[0100] 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.

[0101] 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).

[0102] In summary, the electrical stimulation intensity adjustment method provided by the embodiments of the present invention can ensure that the intensity increase adjustment is performed during the intensity maintenance phase of the electrical stimulation pulse sequence, and ensure that the intensity decrease phase begins after the intensity increase is completed, thus ensuring the safety and reliability of the adjustment process.

[0103] 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 control device 10 and a stimulation device 20. The control device 10 may include a controller 110 and a display 120, and the stimulation device 20 may include a stimulator 210 and an electrode 220.

[0104] 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 220 can collect biofeedback information while outputting electrical stimulation. During the patient's contraction and relaxation movements according to the interface prompts, the electrode 220 can be 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 display interface of the monitor 120). If the contraction and relaxation movements do not meet the standards, they can be detected by the electrode 220. At this time, electrical stimulation output will be introduced, releasing a current of a specific frequency and pulse width to electrically stimulate the muscles, thereby ensuring the treatment effect.

[0105] It should be noted that in the various embodiments of the electrical stimulation intensity adjustment method, specific descriptions have been provided 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.

[0106] 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.

[0107] 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 maintenance phase and an intensity reduction phase; The method for adjusting the intensity of electrical stimulation includes: Get the upshift command; When the acquisition time of the upshift command is within the intensity maintenance phase, the intensity of electrical stimulation is increased according to the upshift command, and it is determined whether the upshift can be completed before the end of the intensity maintenance phase. If so, then the intensity decrease phase begins at the end of the intensity holding phase; If not, the intensity reduction phase will begin when the gear shift is completed; Determining whether the gear shift can be completed before the end of the intensity maintenance phase includes: The remaining time of the intensity holding phase is determined based on the acquisition time of the upshift command and the end time of the intensity holding phase; The target gear is determined based on the upshift command and the current gear, and the adjustment time required to shift from the current gear to the target gear is determined. Determine whether the adjustment time is greater than the remaining time; If so, the gear shift cannot be completed before the end of the intensity maintenance phase; If not, the gear shift can be completed before 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 upshift command is an upshift command for N gears, where N is an integer greater than 1; Increasing the intensity of electrical stimulation according to the aforementioned increase command includes: The electrical stimulation intensity is increased step by step from the current level until the target level corresponding to the N-level command is reached.

3. The method for adjusting the intensity of electrical stimulation according to claim 2, characterized in that, The electrical stimulation intensity is increased progressively from the current level until the target level corresponding to the "add N" level command is reached, including: The upshift command is broken down into multiple upshift commands, and the upshift commands are repeatedly executed before the target gear is reached.

4. The method for adjusting the intensity of electrical stimulation according to claim 3, characterized in that, The electrical stimulation device includes a control device and a stimulation device; the control device is used to acquire the N-level increase command. The step of decomposing the upshift command into multiple upshift commands and repeatedly executing the upshift commands before reaching the target gear includes: The control device decomposes the "increase N" command into multiple "increase 1" commands, and before reaching the target level, repeatedly sends the "increase 1" commands to the stimulation device, causing the stimulation device to execute the "increase 1" commands.

5. The method for adjusting the intensity of electrical stimulation according to claim 3, characterized in that, The electrical stimulation device includes a control device and a stimulation device; the control device is used to acquire the N-level increase command. The step of decomposing the upshift command into multiple upshift commands and repeatedly executing the upshift commands before reaching the target gear includes: The control device sends the N-level increase command to the stimulation device; The stimulation device decomposes the "increase N" command into multiple "increase 1" commands, and repeatedly executes the "increase 1" command before reaching the target level.

6. The method for adjusting the intensity of electrical stimulation according to any one of claims 2-5, 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 any one of claims 2-5, 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. The method for adjusting the intensity of electrical stimulation according to claim 1, characterized in that, Also includes: Get the command to pause upshifting; According to the pause and increase command, the increase in electrical stimulation intensity is stopped, and the current intensity is maintained for electrical stimulation.

9. The method for adjusting the intensity of electrical stimulation according to claim 1, characterized in that, Also includes: The display in the electrical stimulation device is controlled to show the current setting and / or the operating information of the current electrical stimulation pulse sequence.

10. An electrical stimulation device, characterized in that, Used to perform the electrical stimulation intensity adjustment method according to any one of claims 1-9.

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