Electrical stimulation device and method of electrical stimulation adjustment

Abstract

The application provides an electric stimulation device and an electric stimulation adjusting method, the electric stimulation device at least comprises a controller and a stimulator, the electric stimulation method comprises the following steps: inputting a control instruction, the control instruction comprises a set gear; the controller acquires the set gear; calculating a first gear difference value between the set gear and a gear before adjustment of the stimulator; and according to the first gear difference value, a real-time gear output by the stimulator is gradually increased according to a reference gear until the real-time gear reaches the set gear, and the stimulator outputs electric stimulation according to the set gear; wherein, there is a multiple N between the first gear difference value and the reference gear, and the multiple N is greater than 1.

Description

Technical Field

[0001] This invention belongs to the field of electronic equipment technology, specifically relating to an electrical stimulation device and an electrical stimulation modulation method. Background Technology

[0002] Of the two existing types of neuromuscular stimulation devices, one type has a controller and stimulator that are an integrated host system, with the controller being, for example, a button or knob; the other type has a controller that is separate from the stimulator, with the controller being, for example, software or a remote control.

[0003] In existing neuromuscular stimulation devices, the intensity of electrical stimulation is adjusted by a controller outputting commands to the stimulator, thereby increasing the amplitude of the stimulator's electrical stimulation output. The process of the controller outputting commands to the stimulator typically involves two methods: one is to adjust the electrical stimulation intensity in increments of one level, with the controller outputting a signal increasing by one level each time, repeating this process multiple times until the stimulator's electrical stimulation intensity reaches the target intensity; the other is to adjust the electrical stimulation intensity across multiple levels, with the controller directly outputting a signal increasing by N levels to the stimulator, directly increasing the stimulator's output amplitude by N levels and outputting the electrical stimulation intensity after increasing by N levels.

[0004] The People's Republic of China pharmaceutical industry standard YY 0607-2007, "Medical Electrical Equipment Part 2: Particular Safety Requirements for Nerve and Muscle Stimulators," clearly stipulates that "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." Therefore, in the event of a power interruption followed by restoration, the electrical stimulation intensity needs to be readjusted. The aforementioned step-by-step adjustment of electrical stimulation intensity is cumbersome and time-consuming. Furthermore, in the scheme of adjusting electrical stimulation intensity across multiple levels, directly increasing the stimulator's output amplitude by N levels would result in an increment greater than 1mA or 1V, thus failing to meet the standard's requirement that "the stimulator must be equipped with an output amplitude controller that allows continuous adjustment of the stimulator's output amplitude from minimum to maximum, or intermittent adjustment in increments not exceeding 1mA or 1V."

[0005] In view of this, it is necessary to propose an electrical stimulation device and an electrical stimulation adjustment method that can meet the requirements of the above-mentioned pharmaceutical industry standards, and must also meet the requirements of simple operation and short adjustment time. Summary of the Invention

[0006] The purpose of this invention is to provide an electrical stimulation device and an electrical stimulation adjustment method, overcoming the problems of long adjustment time, cumbersome operation, and non-compliance with standards that are common in existing electrical stimulation device adjustment methods.

[0007] To address the aforementioned problems, the present invention provides an electrical stimulation adjustment method applicable to an electrical stimulation device. The electrical stimulation device includes at least a controller and a stimulator. The electrical stimulation method includes: inputting a control command, the control command including a set level; the controller acquiring the set level; calculating a first level difference between the set level and the stimulator's initial level; and, based on the first level difference, gradually increasing the real-time level output by the stimulator according to a reference level until the real-time level reaches the set level, and the stimulator outputting electrical stimulation according to the set level; wherein the first level difference and the reference level have a multiple N, the multiple N being greater than 1.

[0008] As an optional technical solution, the step of gradually increasing the real-time output level of the stimulator according to the reference level based on the first level difference until the real-time level reaches the set level further includes:

[0009] The controller decomposes the first gear difference into multiple reference gears and sends the multiple reference gears to the stimulator multiple times; the stimulator receives the multiple reference gears multiple times until the real-time gear reaches the set gear.

[0010] As an optional technical solution, the step of gradually increasing the real-time output level of the stimulator according to the reference level based on the first level difference until the real-time level reaches the set level further includes:

[0011] The controller sends the first gear difference to the stimulator; the stimulator decomposes the first gear difference into multiple reference gears, and gradually increases them according to the multiple reference gears until the real-time gear reaches the set gear.

[0012] As optional technical solutions, the following also include:

[0013] The selected treatment plan includes multiple electrical stimulation sequences, each with a corresponding multiple pulse energy, and the multiple pulse energies are different for each other;

[0014] Determine the maximum pulse energy among the plurality of pulse energies, wherein the maximum pulse energy is the maximum value of the first threshold interval;

[0015] The minimum value of the first threshold interval is calculated based on the maximum pulse energy. The minimum value of the first threshold interval is the maximum pulse energy multiplied by a first coefficient, where the first coefficient is less than 1.

[0016] Compare the maximum value of each pulse energy in the plurality of pulse energies with the minimum value of the first threshold interval; and

[0017] The electrical stimulation sequence corresponding to the pulse energy falling within the range of the maximum value and the minimum value of the first threshold interval among the plurality of pulse energies is defined as the first set of electrical stimulation sequences, where the maximum value of the first threshold interval corresponds to the maximum pulse energy.

[0018] The set position includes multiple sub-set positions, each sub-set position corresponds to a set of electrical stimulation sequences; each set of electrical stimulation sequences corresponds to a sub-adjustment position, and each set of electrical stimulation sequences is based on the difference between the sub-set position and the sub-adjustment position, and is gradually increased according to the benchmark position until the corresponding sub-set position is reached, and electrical stimulation is output according to the corresponding sub-set position.

[0019] As optional technical solutions, the following also include:

[0020] The remaining pulse energies that do not fall into the first threshold interval among the plurality of pulse energies are defined as the first remaining group;

[0021] Determine the maximum pulse energy in the first remaining group, and use the maximum pulse energy in the first remaining group as the maximum value of the second threshold interval;

[0022] The minimum value of the second threshold interval is calculated based on the maximum pulse energy in the first remaining group, and the minimum value of the second threshold interval is the maximum pulse energy in the first remaining group multiplied by the first coefficient.

[0023] Compare the pulse energy of each pulse in the first remaining group with the maximum value and the minimum value of the second threshold interval. The maximum pulse energy in the first remaining group corresponds to the maximum value of the second threshold interval.

[0024] The electrical stimulation sequences corresponding to multiple pulse energies falling within the range of the maximum and minimum values ​​of the second threshold interval in the first remaining group are defined as the second group of electrical stimulation sequences; and

[0025] Repeat the above process until all the remaining pulse energy in the first remaining group is distributed to the electrical stimulation sequences of different groups;

[0026] When the treatment plan is run, the real-time level of the stimulator output gradually increases according to the baseline level until it reaches the sub-set level corresponding to each set of electrical stimulation sequences, and outputs electrical stimulation according to the sub-set level corresponding to each set of electrical stimulation sequences.

[0027] As optional technical solutions, the following also include:

[0028] Receive an interrupt command to control the stimulator to stop outputting electrical stimulation; and

[0029] After receiving the stop command, the stimulator receives a new adjustment command and enters an automatic adjustment mode, which includes:

[0030] Retrieve the same treatment plan from the previous run;

[0031] Obtain the set level for each electrical stimulation sequence in the previously run version of the same treatment protocol;

[0032] Based on the set level of each electrical stimulation sequence, the automatic adjustment level of each electrical stimulation sequence is calculated. The automatic adjustment level of each electrical stimulation sequence is the set level multiplied by a second coefficient, where the second coefficient is less than 1.

[0033] Based on the automatic adjustment level of each electrical stimulation sequence, the pre-adjustment level of each electrical stimulation sequence output by the stimulator is moved to the automatic adjustment level of each electrical stimulation sequence;

[0034] Calculate the second level difference between the pre-adjustment level and the set level for each electrical stimulation sequence output by the stimulator; and

[0035] Based on the second level difference, the real-time level of each electrical stimulation sequence output by the stimulator is gradually increased according to the reference level until the real-time level reaches the automatic adjustment level, and each electrical stimulation sequence output by the stimulator outputs the electrical stimulation according to the automatic adjustment level.

[0036] As an optional technical solution, the step of moving from the pre-adjustment setting of each electrical stimulation sequence output by the stimulator to the automatic adjustment setting of each electrical stimulation sequence, based on the automatic adjustment setting of each electrical stimulation sequence, further includes:

[0037] The level is automatically adjusted according to each electrical stimulation sequence, and the real-time level of the stimulator output is gradually increased from the reference level to the first intermediate level.

[0038] Upon receiving a first pause command, the stimulator outputs electrical stimulation at the first intermediate setting.

[0039] Wherein, the first intermediate gear is smaller than the automatic adjustment gear.

[0040] As an optional technical solution, based on the first level difference, the real-time level of the stimulator output is gradually increased according to the reference level until the real-time level reaches the set level. The step of the stimulator outputting electrical stimulation according to the set level further includes:

[0041] Based on the first gear difference, the real-time gear output by the stimulator gradually increases from the baseline gear to the second intermediate gear; upon receiving a second pause command, the stimulator outputs electrical stimulation at the second intermediate gear; wherein the second intermediate gear is lower than the set gear.

[0042] As an optional technical solution, the stimulator includes multiple output channels, which can simultaneously output electrical stimulation according to the set level; or, some of the multiple output channels output electrical stimulation according to the set level.

[0043] The present invention provides an electrical stimulation device, which includes a controller and a stimulator, the controller and the stimulator being electrically connected, and the electrical stimulation device adjusting the electrical stimulation output of the stimulator according to the electrical stimulation adjustment method described above.

[0044] As an optional technical solution, the controller includes application software, control buttons or knobs running on the electronic device; the stimulator includes an output end, which is an electrode pad, which is attached to the skin of the human body, and the electrical stimulation output by the stimulator is provided to the human body through the electrode pad.

[0045] Compared with existing technologies, the electrical stimulation device and method provided by this invention divide the set level into multiple reference levels and automatically adjust according to multiple reference units, simplifying user operation while meeting existing standard requirements. Furthermore, during the adjustment process, the electrical stimulation sequences involved in the treatment plan are grouped, and one electrical stimulation sequence from each group is selectively adjusted, which helps simplify the number of adjustments, shorten adjustment time, and improve user experience.

[0046] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments, but this is not intended to limit the present invention. Attached Figure Description

[0047] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0048] Figure 1 This is a flowchart of an electrical stimulation modulation method according to an embodiment of the present invention.

[0049] Figure 2 This is a functional block diagram of an electrical stimulation device according to an embodiment of the present invention.

[0050] Figure 3This is a functional block diagram of the electrical stimulation device and user interaction in one embodiment of the present invention.

[0051] Figure 4 This is a functional block diagram of the electrical stimulation device and user interaction in another embodiment of the present invention.

[0052] Figure 5 This is a functional block diagram of a treatment plan in one embodiment of the present invention.

[0053] Figure 6 This is a schematic diagram of the stimulation pattern of a treatment scheme in one embodiment of the present invention.

[0054] Figure 7 This is a schematic diagram of an electrical stimulation sequence in one embodiment of the present invention.

[0055] Figure 8 This is a schematic diagram of an electrical stimulation pulse in one embodiment of the present invention. Detailed Implementation

[0056] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments and accompanying drawings. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0057] In the description of this invention, it should be noted that the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing this invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0058] like Figure 1 and Figure 2 As shown, in one embodiment of the present invention, an electrical stimulation modulation method 10 is provided, applicable to an electrical stimulation device 100. The electrical stimulation device 100 includes at least a controller 110 and a stimulator 120. The electrical stimulation modulation method 10 includes:

[0059] Input control commands, the control commands including setting gears

[0060] Controller 110 obtains the set gear;

[0061] Calculate the first gear difference between the set gear and the stimulator's initial adjustment gear; and

[0062] Based on the first gear difference, the real-time gear output by the stimulator 120 gradually increases according to the reference gear until the real-time gear reaches the set gear, and the stimulator 120 outputs electrical stimulation according to the set gear.

[0063] The set gear and the base gear are separated by a multiple N, where the multiple N is greater than 1.

[0064] In a preferred embodiment, such as Figure 3 As shown, the user outputs the set level to the controller 110. The controller 110 calculates the first level difference between the set level and the stimulator's pre-adjustment level, decomposes the first level difference into multiple reference levels, and sends multiple reference levels to the controller 120 multiple times. The stimulator 120 receives multiple reference levels multiple times until the real-time level gradually increases to the set level.

[0065] For example, the baseline level is level 1, the set level is level 5, the initial level is level 0, and the difference between the first and second levels is level 5. For each additional baseline level 1 added to the stimulator 120, the electrical stimulation intensity applied to the user's skin by the stimulator 120 increases by level 1. Specifically, when gradually increasing from level 0 to level 5, the electrical stimulation intensity applied to the user's skin by the stimulator 120 increases to level 5.

[0066] In this embodiment, the controller 110 decomposes the first level difference of 5 levels into 5 reference levels. The 5 reference levels are sent to the stimulator 120 in 5 separate transactions. Each time the stimulator 120 receives a reference level, the electrical stimulation intensity of the stimulator 120 increases by 1 level. After 5 increases, the electrical stimulation intensity of the stimulator 120 increases to level 5.

[0067] In addition, after the stimulator 120 receives a reference level and increases the electrical stimulation intensity by one level, the stimulator 120 feeds back the real-time level signal to the controller 110, and the controller 110 continues to resend the next reference level to the stimulator 120. The real-time level is the superposition of the previous level and the reference level.

[0068] Finally, when the stimulator 120 reports that the real-time setting matches the set setting, the controller 110 stops sending the reference setting to the stimulator 120.

[0069] In another preferred embodiment, such as Figure 4 As shown, the user outputs the set level to the controller 110. The controller 110 calculates the first level difference between the set level and the stimulator's pre-adjustment level and sends the first level difference to the stimulator 120. The stimulator 120 decomposes the first level difference into multiple reference levels and gradually increases them according to the multiple reference levels until the real-time level and the set level are consistent.

[0070] For example, the baseline level is level 1, the set level is level 5, the previous level is level 0, and the first level difference is level 5. The controller 110 sends the increase of level 5 to the stimulator 120. The stimulator 120 divides the first level difference of level 5 into 5 baseline levels. The stimulator 120 increases by 1 level each time until the electrical stimulation intensity increases to level 5.

[0071] Finally, as the electrical stimulation intensity of the stimulator 120 increases to level 5, the level information of the electrical stimulation is fed back to the controller 110 in real time.

[0072] Furthermore, as the stimulator 120 gradually increases the level according to the baseline, if the user feels that the electrical stimulation at the current level is unbearable or has reached its upper limit, a second pause command can be provided through the pause unit on the controller 110. The controller 110 outputs the second pause command to the stimulator 120, and the stimulator 120 maintains the current real-time level for electrical stimulation output. The current real-time level is typically lower than the set level.

[0073] For example, based on the first level difference, the real-time level of the stimulator 120 output gradually increases from the baseline level to the second intermediate level.

[0074] Upon receiving the second pause command, the stimulator 120 outputs electrical stimulation at the second intermediate setting.

[0075] The second intermediate gear is lower than the set gear.

[0076] As can be seen from the above, in the electrical stimulation adjustment method 10, the set position is divided into multiple reference positions by the controller 110 or the stimulator 120, and the stimulator 120 is controlled to automatically and gradually increase according to the multiple reference positions until the real-time position is consistent with the set position, and the stimulator outputs electrical stimulation according to the set position.

[0077] For users, the operation is simple because only a single input of the setting level is required, eliminating the need to select multiple levels. The stimulator continuously increases the setting level gradually according to the baseline, ensuring that the adjustment method of electrical stimulation meets the relevant provisions of the People's Republic of China medical industry standard "YY 0607-2007 Medical Electrical Equipment Part 2: Particular Requirements for Safety of Nerve and Muscle Stimulators".

[0078] The electrical stimulation device 100 also includes a storage unit, which often stores multiple treatment plans. Each treatment plan corresponds to one or more therapeutic effects, including but not limited to analgesia, anti-inflammation, and massage.

[0079] like Figure 5 and Figure 6As shown, each treatment plan typically includes multiple treatment phases, which run cyclically. Each treatment phase often consists of one or more electrical stimulation sequences; the pulse width and pulse frequency combinations of different electrical stimulation sequences are different. Because the pulse width and pulse frequency combinations of different electrical stimulation sequences are different, the pulse energy output by different electrical stimulation sequences varies. Therefore, it is necessary to set the intensity of the electrical stimulation sequences to ensure that the output pulse energy is within the range that the user can tolerate.

[0080] like Figure 6 As shown, each treatment regimen runs for a period of time, and each treatment period includes multiple sets of stimulation times and multiple sets of rest times for running the electrical stimulation sequence, with the stimulation times and rest times running alternately.

[0081] like Figure 7 As shown, the operation of each electrical stimulation sequence includes a rise time, a level time, a fall time, and a rest time. The rise time cannot be 0, while the level time, fall time, and rest time can all be 0. The stimulation time of each electrical stimulation sequence consists of the rise time, the level time, and the fall time.

[0082] like Figure 8 As shown, the differences in each electrical stimulation sequence are determined by the waveform, pulse width, and frequency of the electrical stimulation pulses.

[0083] Furthermore, considering significant individual differences among users—that is, different users have different tolerance levels to electrical stimulation—when different users use the electrical stimulation device 100, after inputting the treatment plan, it is necessary to adjust one or more electrical stimulation sequences in the treatment plan. Since each treatment plan usually includes multiple electrical stimulation sequences, it is necessary to adjust each of the multiple electrical stimulation sequences separately so that the pulse energy corresponding to the electrical stimulation can be tolerated by the user.

[0084] Adjusting each of the multiple electrical stimulation sequences separately results in long adjustment times, leading to long waiting times and a poor user experience.

[0085] In the above-described electrical stimulation adjustment method 10, this invention groups multiple electrical stimulation sequences in each treatment plan into multiple different groups of electrical stimulation sequences. A representative electrical stimulation sequence from each group is selected for intensity adjustment, and the other electrical stimulation sequences in each group are also output according to their corresponding preset intensity levels. That is, after grouping, only a single representative electrical stimulation sequence in each group is adjusted, significantly reducing the number of adjustments required. Therefore, the adjustment time can be significantly shortened, allowing the treatment plan to be executed faster and improving execution efficiency.

[0086] In a preferred embodiment, the electrical stimulation modulation method 10 further includes:

[0087] The treatment plan is selected, which includes multiple electrical stimulation sequences, each with corresponding multiple pulse energies.

[0088] Determine the maximum pulse energy among multiple pulse energies; the maximum pulse energy is the maximum value in the first threshold interval.

[0089] The minimum value of the first threshold interval is calculated based on the maximum pulse energy. The minimum value of the first threshold interval is the maximum pulse energy multiplied by a first coefficient, where the first coefficient is less than 1.

[0090] Compare the maximum value and minimum value of each pulse energy in the first threshold interval among multiple pulse energies;

[0091] The electrical stimulation sequence corresponding to the pulse energy that falls within the range of the maximum value and the minimum value of the first threshold interval is identified as the first set of electrical stimulation sequences.

[0092] The maximum value of the first threshold interval corresponds to the maximum pulse energy mentioned above. When the treatment plan is running, the real-time output level of the stimulator 120 gradually increases according to the baseline level until the set level is reached.

[0093] In addition, when running the treatment plan, the setting includes multiple sub-settings, each sub-setting corresponds to a set of electrical stimulation sequences; each set of electrical stimulation sequences corresponds to a sub-pre-adjustment setting. Each set of electrical stimulation sequences is based on the difference between the sub-setting and the sub-pre-adjustment setting, and is gradually increased according to the baseline setting until the corresponding sub-setting is reached, and electrical stimulation is output according to the corresponding sub-setting.

[0094] Furthermore, the electrical stimulation modulation method 10 also includes:

[0095] The remaining pulse energies that do not fall into the first threshold interval among multiple pulse energies are defined as the first remaining group;

[0096] Determine the maximum pulse energy in the first remaining group, and use the maximum pulse energy in the first remaining group as the maximum value of the second threshold interval;

[0097] The minimum value of the second threshold interval is calculated based on the maximum pulse energy in the first remaining group. The minimum value of the second threshold interval is the maximum pulse energy in the first remaining group multiplied by the first coefficient.

[0098] Compare the pulse energy of each pulse in the first remaining group with the maximum value of the second threshold interval and the minimum value of the second threshold interval;

[0099] The electrical stimulation sequences corresponding to multiple pulse energies that fall within the range of the maximum value of the second threshold interval and the minimum value of the second threshold interval in the first remaining group are defined as the second group of electrical stimulation sequences.

[0100] Repeat the above process until all the remaining pulse energy in the first remaining group is distributed to the electrical stimulation sequences of different groups;

[0101] When the treatment plan is running, the real-time output level of the stimulator 120 gradually increases from the baseline level until it reaches the sub-set level corresponding to each electrical stimulation sequence, and outputs electrical stimulation according to the sub-set level corresponding to each electrical stimulation sequence. For example, the treatment plan may be an analgesic treatment plan, which includes multiple electrical stimulation sequences as shown in the table below.

[0102] Table 1. Multiple electrical stimulation sequences for analgesia protocols

[0103]

[0104]

[0105] Take a first coefficient of 0.7 as an example.

[0106] Electrical stimulation sequence 10 has a maximum pulse energy of 19 mJ; therefore, the maximum value of the first threshold interval is 19 mJ; and 19 mJ × 0.7 = 13.3 mJ; that is, the minimum value of the first threshold interval is 13.3 mJ. Therefore, the range of the first threshold interval is 13.3 mJ to 19 mJ; at this time, electrical stimulation sequences with pulse energies between 13.3 mJ and 19 mJ are defined as the first group of electrical stimulation sequences.

[0107] In Table 1 above, electrical stimulation sequences 5 to 10 constitute the first group of electrical stimulation sequences. At this time, the pulse energies of each electrical stimulation sequence in the first group are close to each other. Therefore, after obtaining the treatment plan, the stimulator 120 gradually increases from the baseline level to the set level, selecting only electrical stimulation sequence 10 for adjustment. If the user can adapt to the pulse energy of electrical stimulation output by electrical stimulation sequence 10 at the set level, it is assumed that the user can also adapt to the pulse energy of electrical stimulation output by other electrical stimulation sequences 5-9 at the set level during the subsequent formal treatment process.

[0108] Similarly, the remaining electrical stimulation sequences 1-4 in electrical stimulation sequences 1-10 are defined as the first residual group. The maximum pulse energy in the first residual group is 13mJ, which serves as the maximum value of the second threshold interval. 13mJ × 0.7 = 9.1mJ, that is, the minimum value of the second threshold interval is 9.1mJ. Therefore, the range of the second threshold interval is 9.1mJ to 13mJ. At this time, electrical stimulation sequences with pulse energies between 9.1mJ and 13mJ are defined as the second group of electrical stimulation sequences.

[0109] In Table 1 above, electrical stimulation sequences 1 to 4 constitute the second group of electrical stimulation sequences. At this time, the pulse energies corresponding to each electrical stimulation sequence in the second group are close to each other. Therefore, after obtaining the treatment plan, as the stimulator 120 gradually increases from the baseline level to the set level, only electrical stimulation sequence 4 is selected for adjustment. If the user can adapt to the pulse energy of electrical stimulation sequence 4 at the set level, then in the subsequent formal treatment process, it is assumed that the user can also adapt to the pulse energy of electrical stimulation sequences 1-3 at the set level.

[0110] The above method groups multiple electrical stimulation sequences into different groups. After grouping, only the electrical stimulation sequence with the maximum pulse energy in each group is selected for adjustment, while other electrical stimulation sequences do not need to be adjusted. This can significantly reduce the number of adjustments, shorten the adjustment time, and improve treatment efficiency.

[0111] In other embodiments of the present invention, the pulse frequency, pulse width, and pulse energy corresponding to the electrical stimulation sequence can be other values ​​and can be set according to actual treatment needs. The first coefficient is not limited to 0.7, and the grouping of multiple electrical stimulation sequences is not limited to a first group of electrical stimulation sequences and a second group of electrical stimulation sequences. A reasonable threshold range is set according to actual needs to ensure that multiple electrical stimulation sequences are all assigned to different groups.

[0112] In addition, if the treatment plan is interrupted during use of the electrical stimulation device 100 (due to power failure or other reasons), the electrical stimulation adjustment method 10 also includes:

[0113] Upon receiving an interrupt command, the stimulator 120 is controlled to stop outputting electrical stimulation; and

[0114] After the interruption command, the electrical stimulation device 100 restarts, the controller 110 receives the adjustment command, and the stimulator 120 enters the automatic adjustment mode, which includes:

[0115] Retrieve the same treatment plan from the previous run;

[0116] Retrieve the setpoint for each electrical stimulation sequence in the previous run of the same treatment plan;

[0117] Based on the set level of each electrical stimulation sequence, the automatic adjustment level of each electrical stimulation sequence is calculated. The automatic adjustment level of each electrical stimulation sequence is the set level of each electrical stimulation sequence multiplied by a second coefficient, where the second coefficient is less than 1.

[0118] Based on the automatic adjustment level of each electrical stimulation sequence, the pre-adjustment level of each electrical stimulation sequence output by the stimulator 120 is moved to the automatic adjustment level of each electrical stimulation sequence.

[0119] Calculate the second level difference between the pre-adjustment level and the set level for each electrical stimulation sequence output by stimulator 120; and

[0120] Based on the second level difference, the real-time level of each electrical stimulation sequence output by the stimulator 120 is gradually increased according to the reference level until the automatic adjustment level is reached, and each electrical stimulation sequence output by the stimulator outputs the electrical stimulation according to the automatic adjustment level.

[0121] In this embodiment, the setting level of the previous operation specifically includes multiple different setting levels corresponding to different treatment plans in the previous operation. For example, the electrical stimulation device 100 records the setting level of the last operation of each treatment plan.

[0122] This automatic adjustment mode makes the adjustment of the electrical stimulation device 100 more intelligent, overcoming the problem that existing electrical stimulation devices require manual readjustment of all levels and electrical stimulation sequences when the treatment plan is interrupted and needs to be reselected.

[0123] The aforementioned interruption commands include situations such as shutdown, power outage, and exiting the treatment plan. After the interruption command, the electrical stimulation device 100 restarts, which means that the electrical stimulation device 100 resumes the treatment plan, receives adjustment commands again, and enters the automatic adjustment mode.

[0124] Furthermore, the pulse energy of electrical stimulation that a single user can tolerate varies at different times. Therefore, the aforementioned automatic adjustment mode also provides a pause mode.

[0125] The level is automatically adjusted according to each electrical stimulation sequence. The real-time level of the stimulator 120 output is gradually increased from the reference level to the first intermediate level.

[0126] Upon receiving the first pause command, the stimulator 120 outputs electrical stimulation at the first intermediate setting.

[0127] Among them, the first intermediate gear is lower than the automatic adjustment gear.

[0128] For example, if the second coefficient is 0.8, and the setting of the previous electrical stimulation sequence was level 5, the intensity of the output electrical stimulation was level 5; then, the automatic adjustment level of the corresponding electrical stimulation sequence is level 4, and the intensity of the output electrical stimulation is level 4; furthermore, the first intermediate level is level 3, and the intensity of the output electrical stimulation is level 3.

[0129] In a preferred embodiment, the stimulator 120 may include, for example, a plurality of output channels, which simultaneously output electrical stimulation at a set level; or, a portion of the plurality of output channels output electrical stimulation at the set level.

[0130] The present invention also provides an electrical stimulation device 100, which includes a controller 110 and a stimulator 120, the controller 110 and the stimulator 120 being electrically connected to perform signal interaction, wherein the electrical stimulation device 100 is adjusted according to the above-described electrical stimulation method 10 so that the stimulator 120 outputs electrical stimulation.

[0131] In a preferred embodiment, the controller 110 includes application software running on the electronic device, control buttons or knobs, etc.; the stimulator 120 includes an output terminal 121, which is an electrode pad. The electrode pad is attached to the skin of the human body, and the electrical stimulation output by the stimulator 120 is provided to the human body through the electrode pad.

[0132] In addition, the controller 10 also includes a display interface, which can display real-time gear position and adjusted electrical stimulation sequence information (pulse frequency, pulse width, pulse energy, etc.). As the adjustment is carried out, the real-time gear position and electrical stimulation sequence information can be updated in real time to make the adjustment process more intuitive.

[0133] It should be noted that the above-mentioned electrical stimulation adjustment method 10 begins after the electrode pads are attached to the skin of the human body. Furthermore, the above-mentioned electrical stimulation adjustment method 10 is a pre-adjustment process after the treatment plan is selected. In this process, the controller 110 or the stimulator 120 decomposes the first level difference into multiple reference levels. The pre-adjustment level of the stimulator 120 is automatically and gradually adjusted according to these multiple reference levels, simplifying user operation while meeting existing standard requirements.

[0134] During the pre-conditioning process, multiple electrical stimulation sequences in each treatment plan are grouped, and only the electrical stimulation sequence corresponding to the maximum pulse energy in each group is adjusted to output electrical stimulation according to the corresponding sub-set level. When the treatment plan is officially run, other electrical stimulation sequences in each group can also output electrical stimulation according to the corresponding sub-set level by default. In this process, the electrical stimulation sequences are grouped during pre-conditioning, eliminating the need to adjust each electrical stimulation sequence individually. This simplifies the number of adjustments required during pre-conditioning, helps to shorten the adjustment time of the pre-conditioning process, and improves the user experience.

[0135] In summary, the electrical stimulation device and method provided by this invention decompose the first-level difference between the set level and the pre-adjustment level into multiple reference levels. The stimulator automatically adjusts according to multiple reference units, simplifying user operation while meeting existing standard requirements. Furthermore, during the pre-adjustment process, the electrical stimulation sequences involved in the treatment plan are grouped, and one electrical stimulation sequence from each group is selectively adjusted, which helps simplify the number of adjustments, shorten the adjustment time, and improve the user experience.

[0136] The present invention has been described by the above-described embodiments; however, these embodiments are merely examples for implementing the present invention. Furthermore, the technical features involved in the different embodiments of the present invention described above can be combined with each other as long as they do not conflict with each other. It must be noted that the present invention may have other various embodiments, and those skilled in the art can make various corresponding changes and modifications based on the present invention without departing from its spirit and essence; however, all such corresponding changes and modifications should fall within the protection scope of the appended claims.

Claims

1. An electrical stimulation modulation method, applicable to an electrical stimulation device, the electrical stimulation device comprising at least a controller and a stimulator, characterized in that, The electrical stimulation modulation method includes: Input control commands, including setting a gear; The controller acquires the set gear; Calculate the first gear difference between the set gear and the stimulator's initial adjustment gear; and Based on the first gear difference, the real-time gear output of the stimulator gradually increases according to the reference gear until the real-time gear reaches the set gear, and the stimulator outputs electrical stimulation according to the set gear. Wherein, the first gear difference and the reference gear have a multiple N, and the multiple N is greater than 1; The electrical stimulation modulation method further includes: The selected treatment plan includes multiple electrical stimulation sequences, each with a corresponding multiple pulse energy, and the multiple pulse energies are different for each other; Determine the maximum pulse energy among the plurality of pulse energies, wherein the maximum pulse energy is the maximum value of the first threshold interval; The minimum value of the first threshold interval is calculated based on the maximum pulse energy. The minimum value of the first threshold interval is the maximum pulse energy multiplied by a first coefficient, where the first coefficient is less than 1. Compare the maximum value of each pulse energy in the plurality of pulse energies with the minimum value of the first threshold interval; and The electrical stimulation sequence corresponding to the pulse energy falling within the range of the maximum value and the minimum value of the first threshold interval among the plurality of pulse energies is defined as the first set of electrical stimulation sequences, where the maximum value of the first threshold interval corresponds to the maximum pulse energy. The remaining pulse energies that do not fall into the first threshold interval among the plurality of pulse energies are defined as the first remaining group; Determine the maximum pulse energy in the first remaining group, and use the maximum pulse energy in the first remaining group as the maximum value of the second threshold interval; The minimum value of the second threshold interval is calculated based on the maximum pulse energy in the first remaining group, and the minimum value of the second threshold interval is the maximum pulse energy in the first remaining group multiplied by the first coefficient. Compare the pulse energy of each pulse in the first remaining group with the maximum value and the minimum value of the second threshold interval. The maximum pulse energy in the first remaining group corresponds to the maximum value of the second threshold interval. The electrical stimulation sequences corresponding to multiple pulse energies falling within the range of the maximum and minimum values ​​of the second threshold interval in the first remaining group are defined as the second group of electrical stimulation sequences; and Repeat the above process until all the remaining pulse energy in the first remaining group is distributed to the electrical stimulation sequences of different groups; The set position includes multiple sub-set positions, each sub-set position corresponds to a set of electrical stimulation sequences; each set of electrical stimulation sequences corresponds to a sub-adjustment position, and each set of electrical stimulation sequences is based on the difference between the sub-set position and the sub-adjustment position, and is gradually increased according to the benchmark position until the corresponding sub-set position is reached, and electrical stimulation is output according to the corresponding sub-set position.

2. The electrical stimulation modulation method according to claim 1, characterized in that, Based on the first level difference, the step of gradually increasing the real-time level of the stimulator output according to the reference level until the real-time level reaches the set level further includes: The controller decomposes the first gear difference into multiple reference gears and sends the multiple reference gears to the stimulator multiple times. The stimulator receives the multiple reference levels multiple times until the real-time level reaches the set level.

3. The electrical stimulation modulation method according to claim 1, characterized in that, Based on the first level difference, the step of gradually increasing the real-time level of the stimulator output according to the reference level until the real-time level reaches the set level further includes: The controller sends the first gear difference to the stimulator; The stimulator decomposes the first level difference into multiple reference levels, and gradually increases according to the multiple reference levels until the real-time level reaches the set level.

4. The electrical stimulation modulation method according to claim 1, characterized in that, Also includes: Upon receiving an interrupt command, the stimulator is controlled to stop outputting electrical stimulation. as well as After the interruption command is received, the adjustment command is received again, and the stimulator enters an automatic adjustment mode, which includes: Retrieve the same treatment plan from the previous run; Obtain the set level for each electrical stimulation sequence in the previously run version of the same treatment protocol; Based on the set level of each electrical stimulation sequence, the automatic adjustment level of each electrical stimulation sequence is calculated. The automatic adjustment level of each electrical stimulation sequence is the set level multiplied by a second coefficient, where the second coefficient is less than 1. Based on the automatic adjustment level of each electrical stimulation sequence, the pre-adjustment level of each electrical stimulation sequence output by the stimulator is moved to the automatic adjustment level of each electrical stimulation sequence. Calculate the second level difference between the pre-adjustment level and the set level for each electrical stimulation sequence output by the stimulator; and Based on the second level difference, the real-time level of each electrical stimulation sequence output by the stimulator is gradually increased according to the reference level until the real-time level reaches the automatic adjustment level, and each electrical stimulation sequence output by the stimulator outputs the electrical stimulation according to the automatic adjustment level.

5. The electrical stimulation modulation method according to claim 4, characterized in that, The step of moving from the pre-adjustment setting of each electrical stimulation sequence output by the stimulator to the automatic adjustment setting of each electrical stimulation sequence, based on the automatic adjustment setting of each electrical stimulation sequence, further includes: The level is automatically adjusted according to each electrical stimulation sequence, and the real-time level of the stimulator output is gradually increased from the reference level to the first intermediate level. Upon receiving a first pause command, the stimulator outputs electrical stimulation at the first intermediate setting. Wherein, the first intermediate gear is smaller than the automatic adjustment gear.

6. The electrical stimulation modulation method according to claim 1, characterized in that, Based on the first level difference, the real-time level of the stimulator output is gradually increased according to the reference level until the real-time level reaches the set level. The step of the stimulator outputting electrical stimulation according to the set level further includes: Based on the first gear difference, the real-time gear output by the stimulator is gradually increased from the baseline gear to the second intermediate gear. Upon receiving a second pause command, the stimulator outputs electrical stimulation at the second intermediate setting. Wherein, the second intermediate gear is smaller than the set gear.

7. The electrical stimulation modulation method according to claim 1, characterized in that, The stimulator includes multiple output channels, which can simultaneously output electrical stimulation according to the set level; or, some of the multiple output channels output electrical stimulation according to the set level.

8. An electrical stimulation device, the electrical stimulation device comprising a controller and a stimulator, the controller and the stimulator being electrically connected, characterized in that, The electrical stimulation device adjusts the electrical stimulation output of the stimulator according to the electrical stimulation adjustment method as described in any one of claims 1-7.

9. The electrical stimulation device according to claim 8, characterized in that, The controller includes application software running on the electronic device, control buttons, or knobs; The stimulator includes an output terminal, which is an electrode pad. The electrode pad is attached to the skin of the human body, and the electrical stimulation output by the stimulator is provided to the human body through the electrode pad.

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