CN210020867U - Electrical stimulation device for vagus nerve of ear - Google Patents

Abstract

The utility model provides a vagus nerve of ear electro photoluminescence device. The device comprises a stimulation module, a battery, an interactive interface and at least one pair of stimulation electrodes for stimulating the vagus nerve projection region of the ear; the interactive interface is used for detecting and identifying the input control signal and determining the treatment parameters according to the control signal; the battery is respectively electrically connected with the interactive interface and the stimulation module and supplies power to the interactive interface and the stimulation module; and the stimulation module is respectively electrically connected with the interaction interface and each pair of stimulation electrodes and is used for controlling each pair of stimulation electrodes to electrically stimulate the vagus nerve projection area of the ear according to the treatment parameters. The utility model discloses a vagus nerve of ear electro photoluminescence device can be in the use and do not need the health care professional supervision of training, and it is very convenient to use.

Description

Electrical stimulation device for vagus nerve of ear

Technical Field

The utility model relates to the technical field of medical equipment, especially, relate to a vagus nerve of ear electro photoluminescence device.

Background

Vagal Nerve Stimulation (VNS) has previously been used to treat epilepsy, depression, and other disorders. After the cholinergic anti-inflammatory pathway of the vagus nerve is proved, the vagus nerve electrical stimulation enters the visual field of more disciplines, and the vagus nerve electrical stimulation is developed on the basis of the visual field for treating diseases such as rheumatoid arthritis, inflammatory bowel diseases, myocardial ischemia reperfusion injury and the like.

The role of autonomic nervous system in chronic pain has been widely recognized, and clinical treatment of neuropathic pain such as migraine, postherpetic neuralgia or complex regional pain syndrome using stellate ganglion blocking or sympathetic nerve destruction has been shown to have good efficacy, but sympathetic nerve destruction can cause irreversible damage to sympathetic nerves, and sympathetic nerve blocking/destruction can also cause a series of problems, such as Horner syndrome, dyshidrosis, neuritis and the like.

However, in the prior art, the electrical stimulation of the vagus nerve of the ear is only used in theoretical and experimental stages, and there is a great need to provide a medical device for relieving pain by electrically stimulating the vagus nerve of the ear.

SUMMERY OF THE UTILITY MODEL

In order to make up the deficiency of the prior art, the utility model provides an ear vagus nerve electrical stimulation device to realize the scheme of vagus nerve electrical stimulation at the ear.

The utility model provides an electrical stimulation device for vagus nerve of ear, which comprises a wearable structure body and a bracket fixed on auricle, wherein the wearable structure body is provided with a stimulation module, a battery and an interactive interface; the interactive interface is used for detecting and identifying an input control signal and determining treatment parameters according to the control signal; the battery is respectively and electrically connected with the interactive interface and the stimulation module and supplies power to the interactive interface and the stimulation module; the support is provided with at least one pair of stimulation electrodes for stimulating the vagus nerve projection area of the ear, and the stimulation module is respectively electrically connected with the interaction interface and each pair of stimulation electrodes and is used for controlling each pair of stimulation electrodes to electrically stimulate the vagus nerve projection area of the ear according to the treatment parameters.

Further optionally, in the apparatus as described above, the interactive interface is implemented by using a mechanical button, and the interactive interface includes a switch button.

Further optionally, in the apparatus as described above, the interactive interface further includes a status indicator light, a treatment duration adjustment button, an intensity adjustment button, and/or a pause/continue button;

the interactive interface also comprises a detection module which is respectively and electrically connected with the switch button, the treatment duration adjusting button and the intensity adjusting button;

the pause/continue button is pressed during treatment to trigger the pause of treatment; when pressed in the pause, triggers the continuation of the treatment.

Further optionally, in the apparatus as described above, the interaction interface is implemented by using an interaction apparatus with a touch display screen, and the interaction apparatus is provided with a switch module.

Further optionally, in the apparatus as described above, a parameter setting module and/or a mode selection module are further provided in the interaction apparatus;

the interactive interface also comprises a detection module which is respectively and electrically connected with the switch module, the parameter setting module and the mode selection module.

Further optionally, in the apparatus as described above, the parameter setting module includes at least one of a frequency setting unit, a voltage setting unit, a current setting unit, a wave width setting unit, a waveform setting unit, and a treatment duration setting unit.

Further optionally, the device as described above, wherein the at least one pair of stimulation electrodes is disposed on a substrate, and wherein the at least one pair of stimulation electrodes is configured to stimulate a first and/or a second projection of the vagus nerve of the ear.

Further optionally, the device as described above, wherein the at least one pair of stimulation electrodes are disposed on two substrates, and wherein one stimulation electrode pair on the substrate is for stimulating a first projection of the vagus nerve of the ear and the other stimulation electrode pair on the substrate is for stimulating a second projection of the vagus nerve of the ear.

Further optionally, the device as described above, wherein the battery is a dry cell battery, a rechargeable battery or a lithium battery;

when the battery is a lithium battery, the device further comprises a charging interface electrically connected with the lithium battery.

Further optionally, the apparatus as described above, the at least one pair of stimulation electrodes being disposed on a support secured to the pinna; the stimulation module, the battery and the interactive interface are all arranged on the bracket, or one part of the stimulation module, the battery and the interactive interface is arranged on the bracket, the other part of the stimulation module, the battery and the interactive interface is arranged on an integrated body,

further, the integrated body is a wearable structural body in a collar shape or other structural bodies convenient to carry;

further, the device also comprises an earplug which is used for plugging the external auditory canal to support the bracket.

The utility model discloses a vagus nerve of ear electro photoluminescence device through adopting above-mentioned technical scheme, can compensate prior art's not enough, provides a medical instrument that is used for vagus nerve of ear electro photoluminescence, and this medical instrument can be in the use and need not receive the supervision of trained health care professional, and it is very convenient to use.

Drawings

The above and other objects, features and advantages of the present disclosure will become more apparent by describing in greater detail exemplary embodiments thereof with reference to the attached drawings, in which like reference numerals generally represent like parts throughout.

Fig. 1 is a block diagram of an embodiment of the electrical vagus nerve stimulation device according to the present invention.

Fig. 2 is a block diagram of another embodiment of the electrical vagus nerve stimulation device according to the present invention.

Fig. 3 is a schematic structural diagram of an interactive interface of the electrical vagus nerve stimulation device according to the present invention.

Fig. 4 is a schematic structural diagram of another interface of the electrical stimulation device for vagus nerve of ear according to the present invention.

FIG. 5 is a schematic diagram of an interactive interface of the interactive interface shown in FIG. 4.

FIG. 6 is a schematic view of another interactive interface of the interactive interface shown in FIG. 4.

Fig. 7 is a schematic diagram of the projected area of the vagus nerve of the ear according to this embodiment.

Fig. 8 is a flowchart illustrating an embodiment of a method for electrical stimulation of the electrical vagus nerve according to the present invention.

Detailed Description

Preferred embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. While the preferred embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

Migraine headaches are ranked very early in the life-span-regulated (DALYs) disability in nervous system-related disorders according to year-to-year global disease burden studies published by Lancet Neurology. For example, in china, the prevalence of migraine is 9.3%, and about 12% of migraine sufferers have at least one attack per year, the impact of migraine on quality of life is enormous, headache in excess of 1/2 can affect work or learning, and nearly 1/3 patients can lack labor or lessons due to headache. 1/2, the number of people in this group is about 6000 million, and this is a potential patient for the vagal nerve stimulation device. And migraine reaches the peak in 25-49 years old, and is the golden age of work, and migraine has big influence to work and quality of life, and this part of patient population has the motivation to seek treatment. In the prior art, the treatment of migraine patients is mainly carried out by oral medicines, including analgesic medicines and triptans medicines, most patients worry about side effects, are not willing to take medicines for a long time, and prefer a noninvasive and safe alternative treatment method.

In addition, the prevalence rate of neuropathic pain in China is 3.3% -8.2%, and the number of patients with neuropathic pain is also increasing year by year through investigation. Typical neuropathic pain includes postherpetic neuralgia, chemotherapy-induced peripheral neuralgia, diabetic peripheral neuralgia, complex regional pain syndrome, central pain after stroke and the like, the pain degree of a patient is high, the influence on the quality of work and life is large, the treatment difficulty is large, the treatment period is long, a plurality of modes of combined treatment are urgently needed, and the patient can more easily receive a non-invasive electrical stimulation mode. The number of patients with neuropathic pain is large, the types of diseases are large, and the market demand of the part of patients is also very large.

Based on the above problems, there is a need to provide a medical device for treating migraine and various neuropathic pains by electrical stimulation of vagus nerve, which is not only non-invasive and safe, but also high in cost performance, and the patient can complete the treatment at home or in a work scene, and the use is very convenient.

The embodiment of the utility model provides an electrical stimulation device of vagus nerve of ear. The device comprises a stimulation module, a battery, an interactive interface and at least one pair of stimulation electrodes for stimulating the vagal nerve projection region of the ear; the interactive interface is used for detecting and identifying the input control signal and determining the treatment parameters according to the control signal; the battery is respectively electrically connected with the interactive interface and the stimulation module and supplies power to the interactive interface and the stimulation module; and the stimulation module is respectively electrically connected with the interaction interface and each pair of stimulation electrodes and is used for controlling each pair of stimulation electrodes to electrically stimulate the vagus nerve projection area of the ear according to the treatment parameters.

In this embodiment, at least one pair of stimulation electrodes for stimulating the projecting region of the vagus nerve of the ear needs to act on the projecting region of the vagus nerve of the ear of the patient, so in the electrical stimulation apparatus of the vagus nerve of the ear of this embodiment, each pair of stimulation electrodes may be disposed on a bracket fixed to the auricle, and the positions of the rest of the stimulation module, the battery and the interaction interface may not be limited.

For example, the stimulation module, the battery, the interaction interface, and the pairs of stimulation electrodes may be integrally disposed on the support.

Alternatively, the stimulation module, the battery and the interactive interface may be partially disposed on the support and partially disposed on an integrated body, for example, the integrated body may be a wearable structure in the shape of a collar, which is hung around the neck of the patient during use. Or the integrated body can be also provided with other structures which are convenient to carry, such as a structure with a clip, and the integrated body can be clipped on the clothes of a patient through the clip when in use; or the structure body can be arranged into a square block shape, a spherical shape or other personalized appearance shapes, and when the medical endoscope is used, a patient holds the medical endoscope or holds the medical endoscope, so that the medical endoscope is convenient to carry and attractive.

The following describes several structures of the electrical stimulation device for vagus nerve of ear, and in practical applications, the electrical stimulation device for vagus nerve of ear of the present invention is not limited to the following embodiments, but should be subject to the limitations of the claims.

Fig. 1 is a block diagram of an embodiment of the electrical vagus nerve stimulation device according to the present invention. As shown in fig. 1, the electrical stimulation device for the vagus nerve of the ear in this embodiment may specifically include two major parts, namely a wearable structure a and a bracket B fixed to an auricle, wherein the wearable structure a is provided with a stimulation module 1, a battery 2 and an interaction interface 3; as shown in fig. 1, in this embodiment, the wearable structural body a is taken as an example of a collar shape. The interactive interface 3 is used for detecting and identifying the input control signal and determining the treatment parameters according to the control signal; the battery 2 is electrically connected with the interactive interface 3 and the stimulation module 1 respectively to supply power for the interactive interface 3 and the stimulation module 1.

For example, the battery 2 of the present embodiment may be a dry cell battery, and may be replaced when the amount of electricity is exhausted. Or the battery 2 can also adopt a common rechargeable battery, and when the electric quantity is exhausted, the rechargeable battery is taken out and is fully charged and then is installed. Or the battery 2 of the embodiment can also be a lithium battery which has stronger cruising ability, does not need to be replaced or frequently charged and is more convenient to use.

As shown in fig. 2, if the battery 2 in the vagus nerve at the ear electrostimulation module of this embodiment is a lithium battery, a charging interface 5 may be further disposed on the wearable structure a at this time, the charging interface 5 is connected to the battery 2, and when the battery 2 is dead, the external charging wire is used to connect the charging interface 5 to the power supply, so that the battery 2 can be charged through the charging interface 5.

As shown in fig. 1 and 2, the wearable structural body a of the present embodiment can be made into an unsealed collar shape, and the collar can be hung on the neck of a patient when in use, so that the wearable structural body a is very convenient to use.

As shown in fig. 1 and fig. 2, the bracket B of the present embodiment may be configured in the shape of an ear contour, so as to be conveniently hung on an auricle and prevent the bracket B from falling off. The support B of this embodiment is provided with at least one pair of stimulation electrodes 4 for stimulating the vagal nerve projection area of the ear, the stimulation module 1 is electrically connected with the interactive interface 3 and each pair of stimulation electrodes 4, respectively, and the stimulation module 1 is configured to control each pair of stimulation electrodes 4 to electrically stimulate the vagal nerve projection area of the ear according to the treatment parameters determined by the interactive interface 3. For example, the treatment parameters of the present embodiment may include at least one of the frequency, voltage, current, wave width, waveform, and treatment duration that the stimulation module 1 controls each pair of stimulation electrodes 4 to electrically stimulate the vagal nerve projection area of the ear. In the electrical stimulation device for the vagus nerve of the ear in the embodiment, the treatment parameters can be configured in advance and cannot be modified when in use; some or all of the treatment parameters may also be adjusted as needed during use.

For example, fig. 3 is a schematic structural diagram of an interactive interface of the electrical stimulation device for vagus nerve of ear according to the present invention. As shown in fig. 3, the interactive interface 3 of the present embodiment can be implemented by using a mechanical button, for example, the interactive interface includes a switch button 30. The switch button 30 is pressed to activate the electrical stimulation device for the vagus nerve at the ear to start operation. If the switch button 30 is clicked again, the switch button 30 is bounced, and the electrical stimulation device for the vagus nerve of the ear is turned off, i.e., the electrical stimulation device for the vagus nerve of the ear stops working. Or in practical application, the switch button 30 may also be turned on and off, and the high and low positions of the switch button 30 themselves have no state change, i.e. no state change of pressing or bouncing, for example, when the switch button 30 is pressed for the first time, the electrical vagus nerve stimulation device of the ear is started to operate, and when the switch button 30 is pressed for the second time, the electrical vagus nerve stimulation device of the ear is turned off, and when the electrical vagus nerve stimulation device of the ear is not seen from the external state of the switch button 30, the electrical vagus nerve stimulation device of the ear is in the on state or the off state, which needs to be determined according to whether the stimulation electrode 4 operates.

In addition, optionally, a status indicator lamp 31, an intensity adjusting button and/or a treatment duration adjusting button may also be disposed in the interactive interface 3.

For example, if the switch button 30 is pressed, the status indicator lamp 31 may be turned on, and it is known that the electrical stimulation device for the vagus nerve of the ear is activated. If the switch button 30 is bounced, the status indicator lamp 31 may be turned off, and it may be known that the electrical stimulation device for the vagus nerve of the ear is turned off.

Further optionally, the status indicator lamp 31 of the present embodiment may also use different colors to indicate the amount of power after being turned on. For example, if the electric quantity is greater than the preset electric quantity threshold, the status indicator lamp 31 may be displayed in a first color, such as blue, to indicate that the electric quantity is sufficient; if the electric quantity is less than or equal to the preset electric quantity threshold value, the status indicator lamp 31 can be displayed in a second color different from the first color, such as orange, to indicate that the electric quantity is insufficient and charging is required. The preset charge threshold of the present embodiment may be empirically selected, such as 20% charge, 30% charge, or other percentage of charge. The first color and the second color may be implemented by other colors, which is not limited herein. In the above technical solution, two levels of electric quantity are taken as an example, in practical application, multi-level electric quantity detection can be further set, and the status indicator lamp 31 correspondingly displays in one color in each level.

Specifically, the interactive interface 3 in the present embodiment may include an intensity adjustment button for one or two gears.

For example, if there are only two selectable intensities, one of the selectable intensities may be set to be current, and the other selectable intensity may be set to be selectable, and then an intensity adjustment button may be set, and the intensity adjustment button may be clicked to switch between the two intensities.

If the selectable intensity has more than two values, such as 10, 8 or other values, then two shift position adjusting buttons, such as an intensity increasing button 32 and an intensity decreasing button 33, can be provided as shown in fig. 3. As shown in fig. 3, on the interactive interface 3, the intensity increase button 32 may be identified with the symbol "I +" and the intensity decrease button 33 may be identified with the symbol "I-".

When the intensity adjusting device is used, a default intensity can be set, and the default intensity can be the intensity which is used more frequently between the maximum intensity and the minimum intensity. In use, if the intensity is not perceived to be sufficient, the intensity may be increased by clicking the intensity increase button 32. If the intensity is perceived to be too great, clicking on the intensity decrease button 33 may be used to decrease the intensity.

It should be noted that the intensity of the present embodiment refers to the magnitude of the intensity of each pair of stimulation electrodes 4 acting on the vagal nerve projection area of the ear, and can be characterized by the magnitude of the current acting on each pair of stimulation electrodes 4 by the stimulation module 1, and therefore, the intensity of the present embodiment may also be the magnitude of the current acting on each pair of stimulation electrodes 4 by the stimulation module 1.

When the auricular vagus nerve electrical stimulation device of the present embodiment is used for treatment, the treatment may be performed once, twice or more daily, and the duration of each treatment may be about 10 to 90 minutes. For example, in some embodiments, the treatment may be administered once for about 20 minutes to about 60 minutes, preferably approximately 30 minutes. The auricular vagus nerve electrical stimulation device of the present embodiment may further include a treatment duration adjustment button to adjust the treatment duration. For example, as shown in fig. 3, a treatment duration increase button 34 and a treatment duration decrease button 35 may be specifically included. As shown in fig. 3, on the interactive interface 3, the treatment duration increase button 34 may be identified with the symbol "T +" and the treatment duration decrease button 35 may be identified with the symbol "T-".

When the treatment device is used, a default treatment duration, such as 30 minutes, can be set, and the default treatment duration can be one of the maximum treatment duration and the minimum treatment duration which is used more frequently. In use, if the treatment duration is perceived to be short, the treatment duration may be extended by clicking the treatment duration increase button 34. If the treatment duration is too long, the treatment duration can be shortened by clicking the treatment duration reduction button 35. Or in practical application, if the treatment duration of each time cannot be changed after being configured in advance, the treatment duration adjusting button may not be set at this time. And when the device is used every time, the device can be instructed according to the preset time length.

Optionally, the interactive interface of this embodiment may further include a detection module (not shown in fig. 3), where the detection module is configured to detect and identify an on signal triggered by the switch button 30 when the switch button 30 is pressed, and obtain the preconfigured treatment parameters if there is no parameter adjustment at this time. At this time, the corresponding stimulation module 1 controls each pair of stimulation electrodes 4 to electrically stimulate the auricular vagus nerve projection region according to the treatment parameters.

The detection module can also be used for detecting and identifying an intensity adjusting signal triggered by the intensity increasing button 32 or the intensity decreasing button 33, and adjusting the intensity based on the intensity adjusting signal; the magnitude of the intensity may also be understood as the magnitude of the current that stimulation module 1 controls each pair of stimulation electrodes 4 to electrically stimulate the auricular vagal nerve projection region. Then, the treatment parameters can be determined by combining the configured parameters such as frequency, voltage, wave width, waveform, treatment duration and the like.

Similarly, the detection module can be further configured to detect and identify a treatment duration adjustment signal triggered by the treatment duration increase button 34 or the treatment duration decrease button 35, and adjust the size of the treatment duration based on the treatment duration adjustment signal. Then, the treatment parameters can be determined by combining the configured parameters such as frequency, voltage, current, wave width, waveform and the like.

Further optionally, in this embodiment, after the switch button 30 is pressed, the detection module is further configured to start timing, and determine whether the time duration for starting the treatment reaches the configured treatment duration, and if so, trigger the switch button 30 to bounce to turn off the electrical stimulation device for the vagus nerve of the ear. It can be understood that the switch button 30 triggers a turn-off signal, which is detected and recognized by the detection module in the interactive interface 3 and transmitted to the stimulation module 1. Correspondingly, the stimulation module 1 controls each pair of stimulation electrodes 4 to stop performing the electrical stimulation on the auricular vagus nerve projection region according to the closing signal.

In the interactive interface shown in fig. 3, the time when the switch button 30 is pressed can be used as the treatment starting time, and the adjustment of the treatment duration and the adjustment of the intensity can be considered to occur during the treatment without affecting the treatment duration. Or, the detecting module may detect whether the intensity increasing button 32, the intensity decreasing button 33, the treatment duration increasing button 34, or the treatment duration decreasing button 35 is pressed within a preset time length, such as 2s, 3s, or other time length after the switch button 30 is pressed, and if any one of the buttons is pressed, adjust the relevant treatment parameters according to the corresponding request, at this time, the response time of the detecting module may be ignored, and the time when the last button of all the buttons is clicked may be taken as the treatment starting time.

Further optionally, in the interactive interface shown in fig. 3, a pause/continue button may be further provided for triggering the pause of the treatment when pressed during the treatment; when pressed in the pause, triggers the continuation of the treatment. That is, pressing one button indicates pause, and pressing the other button indicates continuation. After the treatment is started, when the treatment needs to be suspended due to personal reasons such as the need of answering the phone or going to a toilet and the like, a user can press the suspension/continuation button to trigger a suspension signal, at the moment, the detection module sends the suspension signal to the stimulation module 1 after detecting the suspension signal, and the stimulation module 1 controls each pair of stimulation electrodes 4 to suspend to electrically stimulate the vagus nerve projection area of the ear according to the suspension signal.

Further, when the user is busy and can continue the treatment, the pause/continue button is pressed again to trigger the start signal after the pause. At this time, if the detection module detects a start signal triggered by the pause/continue button, the detection module sends the start signal to the stimulation module 1, and the stimulation module 1 controls each pair of stimulation electrodes 4 to continue to perform electrical stimulation on the auricular vagus nerve projection area according to the treatment parameters before pause according to the start signal. And after continuing the treatment, the total treatment duration is accumulated on the basis of the treatment duration before the pause. For example, if the preset treatment time required for a certain treatment is 30 minutes, after 10 minutes of treatment, the treatment is suspended for 5 minutes, then the treatment is started again, and after the treatment is continued, the treatment is required to be performed again for 20 minutes until the treatment is completed. Correspondingly, the detection module needs to accumulate the total treatment duration before and after the pause to reach the preset treatment duration, and then sends a closing signal to the stimulation module 1, closes the stimulation module 1, and closes the vagus nerve electrical stimulation device of the ear. In this embodiment, the pause/continue button is used as one button, and in practical application, two buttons may be set as the pause button and the continue button, respectively, and the implementation principle is the same as above, and is not described herein again.

However, after the user pauses the treatment, the user may forget to go back to continue the treatment, so that the device is always charged to wait for the user to go back to continue the treatment, and the consumption is too large. The predetermined time period may be empirically selected, and may be 5 minutes, 10 minutes, or other minutes. At this moment, after the treatment is suspended, the detection module is further used for detecting whether the suspension time length reaches the preset time length, if so, the detection is stopped, a closing signal is sent to the stimulation module 1, the stimulation module 1 is closed, and the vagus nerve electrical stimulation device of the ear is closed.

For example, fig. 4 is a schematic structural diagram of another interface of the electrical stimulation device for vagus nerve of ear according to the present invention. The interactive interface 3 of the present embodiment can be implemented by using an interactive device with a touch display screen. Specifically, in order to facilitate the operation of the interactive apparatus, in the present embodiment, all modules of the interactive apparatus are displayed in the interactive interface of the interactive apparatus, and the patient or the doctor may initiate the function of each module by clicking each button in the interactive interface through the touch screen.

For example, as shown in fig. 4, a switch module 36 is provided in the interaction device. By clicking the switch module 36 through the touch screen, the ear vagus nerve electrical stimulation device is correspondingly activated to start working. If the switch module 36 is clicked again, the ear vagus nerve electrical stimulation device is turned off accordingly. When the electrical stimulation device for the vagus nerve of the ear is turned on and off, the display brightness or the display color of the switch module 36 in the interactive interface may be different to inform that the switch module 36 is in the on or off state.

Further optionally, as shown in fig. 4, a parameter setting module 37 and/or a mode selection module 38 may also be disposed in the interactive interface of the interactive interface, and fig. 4 exemplifies that the parameter setting module 37 and the mode selection module 38 are included at the same time. In addition, as shown in fig. 4, the interactive apparatus of this embodiment may further include a detection module, which runs in the background and is not displayed in the interactive interface, so that it is not shown in fig. 4.

Specifically, the interactive device may only include the switch module 36 and the detection module, when the operator clicks, the detection module detects and identifies the on signal, obtains the pre-configured treatment parameters, and sends the pre-configured treatment parameters to the stimulation module 1, so that the stimulation module 1 controls each pair of stimulation electrodes 4 to electrically stimulate the auricular vagus nerve projection region according to the configured treatment parameters. In this manner, all treatment parameters including frequency, voltage, current, wave width, waveform, and duration of treatment are fixed and cannot be selectively modified by the patient.

If the interactive device further comprises a parameter setting module 37, it means that all parameters can be set by the patient himself. When the patient clicks the parameter setting module 37, the detection module detects and recognizes the input parameter setting request, and an interactive interface as shown in fig. 5 may be popped up to display the parameter setting unit available for setting to the patient. In practical applications, at least one of the frequency setting unit, the voltage setting unit, the current setting unit, the wave width setting unit, the waveform setting unit and the treatment duration setting unit may be displayed in the interactive interface, and fig. 5 includes all the units as an example. The detection module is further configured to detect each setting unit in the interactive interface shown in fig. 5. If the detection module detects and identifies that any setting unit is clicked, all the optional parameters of the unit can be further displayed at the moment, the patient selects the parameters according to the display prompt, and the detection module can detect and identify the set parameters at the moment. For example, if the patient clicks on the frequency setting unit, the interactive interface may display all the frequencies that can be selected, and if there is a default frequency, the current default frequency may be displayed with different brightness or different color for differentiation. The patient can select one frequency from the selectable frequencies, and at this time, the interactive interface can return to the previous interface, namely the interface shown in fig. 5, so that the patient can click on the voltage setting unit to select the voltage, click on the current setting unit to select the current, click on the wave width setting unit to select the wave width, or click on the waveform setting unit to select the waveform in a similar manner. Or in practical application, when each setting unit sets the parameters, the parameters can be directly input by a professional doctor without giving any optional prompt.

If more than one pair of stimulation electrodes 4 are included, the treatment parameters corresponding to each pair of stimulation electrodes 4 may be the same, and the stimulation module 1 may control each pair of stimulation electrodes 4 simultaneously according to the treatment parameters. Or if the treatment parameters corresponding to each pair of stimulation electrodes 4 are different, the display of the identification information of each pair of stimulation electrodes 4 may be added in fig. 4, and then for each pair of stimulation electrodes 4, the corresponding treatment parameters may be set according to the working principle of the parameter setting module 37, which is described in the above embodiments in detail and is not described herein again.

The frequency range of the present embodiment may be 1-500Hz, the voltage range may be 0.5-50v, the current range may be 0.01-100mA, the wave width range may be 50-10000 microseconds, and the waveform may be a sine wave, a square wave, an intermittent wave, or a continuous wave, etc.

In practical applications, a return button may be further disposed in the interactive interface shown in fig. 5, and the patient may return to the interactive interface shown in fig. 4 by clicking the return button.

In addition, the mode selection module 38 of the present embodiment includes at least two disease mode selection modules, as shown in the interactive interface shown in fig. 6. Each disease mode selection module corresponds to a set of preset frequency, voltage, current, wave width, waveform and treatment duration parameter values, which can be selected empirically. Or the preset frequency, voltage, wave width, wave shape and treatment duration parameter values corresponding to each disease mode selection module are preset, and the current can be adjusted according to the requirements of patients. Thus, the detection module may also pop up a current level adjustment interface after detecting that the user selects a disease mode on the disease mode selection interface shown in fig. 6. The current magnitude adjusting interface can only comprise two buttons of increasing and decreasing for the user to adjust the current magnitude, or a plurality of current values can be set for the user to select one; or the current size adjusting interface can comprise a current input box and a current size prompting range input by the current input box, so that a user can input the current size according to the current size prompting range. After the detection module detects the current magnitude set by the user, the current magnitude is bound with the disease mode selected by the user to be used as the treatment parameter set by the user. Then the signals are sent to a stimulation module 1 together, and the stimulation module 1 controls each pair of stimulation electrodes 4 to electrically stimulate the auricular vagus nerve projection region according to the treatment parameters set by the user.

For example, the at least two disease modes of the present embodiment can include migraine modes and neuropathic pain, among others. In practical applications, the electrical stimulation device for the vagus nerve of the ear of the present embodiment may be further applied to the treatment of immune system diseases such as epilepsy, insomnia, anxiety, depression, inflammatory bowel disease, and rheumatoid arthritis.

It should be noted that, when the interactive device includes the parameter setting module 37 and/or the mode selection module 38, after the operator clicks the switch module 36, the detection module does not detect that the parameter setting module 37 or the mode selection module 38 is clicked within a preset time period, such as 2s, 3s, or other time periods, at this time, the treatment parameter obtained by the detection module is a preset default treatment parameter, and is transmitted to the stimulation device, and the stimulation module 1 controls at least one pair of stimulation electrodes to electrically stimulate the vagus nerve of the ear according to the default treatment parameter. If the detection module detects that the parameter setting module 37 or the mode selection module 38 is clicked within the preset time span, the detection module starts to control parameter adjustment or mode selection, and the detection module does not acquire the adjusted treatment parameters or the treatment parameters corresponding to the selected mode until the parameter adjustment or the mode selection is completed, and transmits the treatment parameters to the stimulation module 1; and controlling at least one pair of stimulating electrodes to electrically stimulate the vagus nerve of the ear by the stimulating module 1 according to the adjusted treatment parameters or the treatment parameters corresponding to the selected mode. In the electrical stimulation device for the vagus nerve of the ear, the time length for the detection module to transmit the treatment parameters to the stimulation module 1 is very short and can be ignored, so that the time when the detection module obtains the adjusted treatment parameters or the treatment parameters corresponding to the selected mode can be taken as the time when the treatment starts.

It should be noted that, in the above embodiment, no matter the parameter setting module 37 or the mode selection module 38 is used to select the treatment parameters, after the detection module detects the adjusted treatment parameters or the treatment parameters corresponding to the selected mode, the detection module directly transmits the detected treatment parameters to the stimulation module 1, so as to start the treatment. In order to solve this problem, in this embodiment, after the user clicks the parameter setting module 37, the parameters are set according to the interface shown in fig. 5, or after the user clicks the mode selection module 38 and selects the disease mode, the detection module may already obtain all the treatment parameters required by the user. The detection module then pops up an interactive interface that displays a start button and a pause button to prompt the user whether to start treatment and during which the user may pause. If the user detects that the start button is clicked, the detection module sends the acquired treatment parameters to the stimulation module 1, and the stimulation module 1 controls the stimulation electrode 4 according to the adjusted treatment parameters to start treatment. If the user clicks the pause button in the treatment process, the detection module sends a pause signal to the stimulation module 1, and the stimulation module 1 controls the stimulation electrode 4 to pause the treatment. Further, the detection module is further configured to detect whether the pause duration reaches a certain preset duration, and if so, stop the detection, send a shutdown signal to the stimulation module 1, and shut down the stimulation module 1.

Further optionally, in the vagus nerve of the ear electrostimulation device of the present embodiment, an earplug may be further disposed on the bracket B for plugging in the external auditory canal to support the bracket B and prevent the bracket B from falling off from the auricle.

Further alternatively, in the electrical stimulation apparatus for the vagus nerve of the ear according to the present embodiment, at least one pair of stimulation electrodes 4 may be disposed on a substrate, and at least one pair of stimulation electrodes 4 is used for stimulating the first and/or second projections of the vagus nerve of the ear.

Or at least one pair of stimulation electrodes 4 is disposed on two substrates, and a pair of stimulation electrodes on one substrate is used to stimulate a first projection of the vagus nerve of the ear, and a pair of stimulation electrodes on the other substrate is used to stimulate a second projection of the vagus nerve of the ear.

Fig. 7 is a schematic diagram of the projected area of the vagus nerve of the ear according to this embodiment. The two regions pointed to by the symbols M and N are the first projection region and the second projection region, respectively. For example, the area designated by M may be a first projection area, and the area designated by N may be a second projection area; or the area designated by N may be the first projection area and the area designated by M may be the second projection area. Through a large number of clinical trials, it can be found that the first projection area and the second projection area of the vagus nerve of the ear are the optimal areas for electrical stimulation, and the headache can be relieved by electrically stimulating the areas. When the auricular vagus nerve electrical stimulation device of the embodiment is used for treatment, only the first projection area or the second projection area can be electrically stimulated, and both the first projection area and the second projection area can be electrically stimulated at the same time.

Further optionally, if the battery 2 in the vagal nerve of the ear electrical stimulation device of this embodiment adopts a lithium battery, the interaction interface of the interaction device shown in fig. 4 may further include an electric quantity display module to display the remaining electric quantity percentage. Therefore, the user can charge the device in time when the electric quantity is about to be exhausted, and the normal use of the vagus nerve electrical stimulation device of the ear is ensured. Or further, the system also comprises a cumulative time counting module and a cumulative time display module. The accumulated time counting module is used for accumulating all treatment duration before the current time to obtain an accumulated time. The accumulated time display module is used for displaying the accumulated time counted by the accumulated time counting module so as to inform the patient.

It can be known from the above embodiments that, when the auricular vagus nerve electrical stimulation device of the present embodiment is used, the treatment parameters can be configured in advance, and the auricular vagus nerve electrical stimulation device can be turned on for direct use. The doctor or the patient can also configure the treatment parameters according to the requirements, the configured treatment parameters can be saved as default treatment parameters, and the treatment is carried out according to the default treatment parameters subsequently. Or the treatment parameters can be adjusted at any time during each treatment, so that the individual requirements are realized.

When the auricular vagus nerve electrical stimulation device is used, a patient hangs the wearable structure A on the neck, hangs the bracket B on the auricle, then coats the auricular vagus nerve projection area with the conductive coupling agent, and adheres the stimulation electrode on the bracket B on the surface of the auricular vagus nerve projection area. Next, the stimulation module 1 may be started on the interactive interface 3 to start controlling each pair of stimulation electrodes to electrically stimulate the auricular vagus nerve projection region, which may refer to the above description of the embodiments.

The vagus nerve of ear electro-stimulation device of this embodiment can set up to the structure that the left side ear was used or the right side ear was used according to patient's condition, satisfies different patient's demand.

The vagus nerve of ear electro-stimulation device of this embodiment can compensate prior art's not enough, provides a medical instrument that is used for vagus nerve of ear electro-stimulation, and this medical instrument uses very conveniently, can use at home and do not need the health care professional supervision of training, and it is very convenient to use.

In practical applications, the treatment period of a common patient can be about 1 week to 2 years, or even longer, while the auricular vagus nerve electrical stimulation device of the present embodiment can be provided with a lithium battery for supplying power, which can meet the requirements of patients with any treatment period.

Fig. 8 is a flowchart illustrating an embodiment of a method for electrical stimulation of the electrical vagus nerve according to the present invention. As shown in fig. 8, the electrical stimulation method of the electrical stimulation apparatus for a vagus nerve of the ear according to the present embodiment may specifically include the following steps:

s100, detecting and identifying an input control signal by an interactive interface;

s101, determining treatment parameters by the interactive interface according to the control signals;

s102, the stimulation module controls each pair of stimulation electrodes to electrically stimulate the vagus nerve projection region of the ear according to the treatment parameters determined by the interactive interface.

The electrical stimulation device for the vagus nerve of the ear defined in fig. 1 to 6 is adopted in the electrical stimulation device for the vagus nerve of the ear according to the above embodiments, and the details thereof can be referred to the description of the above embodiments, and are not repeated herein.

For example, the electrical stimulation method of the electrical stimulation apparatus for the vagus nerve of the ear in this embodiment may specifically include the following scenarios:

the first scenario is: when the switch button 30 in fig. 3 or the switch module 36 in fig. 4 is clicked to be turned on, at this time, step S100 may specifically include: the interactive interface detects and identifies an externally input opening signal; for example, an externally input opening signal may be detected and recognized by a detection module in the interactive interface. Correspondingly, in this case, step S101 may specifically include: and the interactive interface acquires the pre-configured treatment parameters according to the opening signal. The step can be realized by a detection module, then the detection module sends the pre-configured treatment parameters to a stimulation module, and the stimulation module controls each pair of stimulation electrodes to electrically stimulate the auricular vagus nerve projection region according to the treatment parameters. In this embodiment, the corresponding treatment parameters are configured, and no adjustment is needed, so the details can refer to the relevant records in the above device embodiment, and are not described herein again.

The second scenario is: when one of the intensity increasing button 32 and the intensity decreasing button 33 in fig. 3 and/or one of the treatment duration increasing button 34 and the treatment duration decreasing button 35 is clicked, at this time, the step S100 may specifically include: the interactive interface detects and identifies the externally input intensity adjusting signal and/or the treatment duration adjusting signal. Correspondingly, in this case, step S101 may specifically include: the interactive interface adjusts the current and/or the treatment duration in the treatment parameters according to the intensity adjusting signal and/or the treatment duration adjusting signal, and then determines the treatment parameters. The two steps may be specifically realized by the detection module, then the detection module sends the adjusted treatment parameters to the stimulation module, and the stimulation module controls each pair of stimulation electrodes to electrically stimulate the vagus nerve auricular projection region according to the adjusted treatment parameters.

The third scenario is: in fig. 5, when at least one of the frequency setting unit, the voltage setting unit, the current setting unit, the wave width setting unit, the waveform setting unit, and the treatment duration setting unit is clicked, at this time, step S100 may specifically include at least one of the following operations:

(a1) the interactive interface detects and identifies an externally input frequency adjustment request, and displays at least one frequency for adjustment based on the frequency adjustment request; detecting and recognizing an adjusted frequency of an external input;

(b1) the interactive interface detects and identifies an externally input voltage adjustment request, and displays at least one voltage for adjustment based on the voltage adjustment request; detecting and recognizing an externally input adjusted voltage;

(c1) the interactive interface detects and identifies an externally input current adjustment request, and displays at least one current available for adjustment based on the current adjustment request; detecting and recognizing an externally input adjusted current;

(d1) the interactive interface detects and identifies an externally input wave width adjusting request, and displays at least one wave width for adjustment based on the wave width adjusting request; detecting and recognizing an adjusted wave width input from the outside;

(e1) the interactive interface detects and identifies an externally input waveform adjustment request, and displays at least one waveform for adjustment based on the waveform adjustment request; detecting and identifying an input adjusted waveform; and

(f1) the interactive interface detects and identifies an externally input treatment duration adjustment request, and displays at least one treatment duration for adjustment based on the treatment duration adjustment request; the entered adjusted treatment duration is detected and identified.

Specifically, the detection module detects each setting unit, if it is detected that a certain setting unit is clicked, the detection module is considered to detect and recognize a parameter adjustment request corresponding to the setting unit, then the detection module can display at least one parameter for adjustment, an operator can select one parameter from the parameters as an adjusted parameter, and the detection module detects and recognizes the input adjusted parameter.

Optionally, after the detection module detects that a certain setting unit is clicked, that is, detects and identifies an input certain parameter adjustment request, a corresponding parameter input window may also be directly popped up, and an experienced doctor or a patient directly inputs the adjusted parameter. And correspondingly detecting and identifying the input adjusted parameters by the detection module.

Correspondingly, step S101 may specifically include: the interactive interface configures the treatment parameters according to at least one of the adjusted frequency, the adjusted voltage, the adjusted current, the adjusted wave width, the adjusted waveform and the adjusted treatment duration. The process may also be implemented by a detection module, and reference may be made to the relevant records of the above embodiments in detail, which are not described herein again.

Optionally, the method defines the adjustment of the treatment parameters, and the electrical stimulation is performed according to the adjusted treatment parameters. The protocol for stopping the treatment is described below. The protocol for discontinuing treatment of this example includes two cases:

in the first case: and stopping treatment after the treatment is finished. The method may specifically include the following steps:

(a2) the interactive interface detects and identifies whether the time length for starting treatment reaches the treatment time length in the configured treatment parameters; if yes, executing step (b 2); otherwise, the detection is continued.

(b2) And the triggering stimulation module controls each pair of stimulation electrodes to stop performing electric stimulation on the vagus nerve projection region of the ear.

The time length of starting the treatment in this embodiment is the time length from the treatment start time to the current time. The steps of this embodiment may be implemented by a detection module in the interactive interface, and details may refer to relevant descriptions of the above method embodiments and are not described herein again.

In the second case: stopping of manual closing. The method may specifically include the following steps:

(a3) detecting and identifying a closing signal input from the outside by the interactive interface;

the close signal may be initiated by the switch button 30 shown in fig. 3 or the switch module 36 of fig. 4 being clicked closed.

(b3) The interactive interface sends a closing signal to the stimulation module;

the steps (a3) and (b3) may be implemented by a detection module in the interactive interface, and details thereof may be found in the relevant description of the above method embodiments and are not repeated herein.

(c3) And the stimulation module controls each pair of stimulation electrodes to stop performing electric stimulation on the vagus nerve projection region of the ear according to the closing signal.

The electrical stimulation method of the electrical stimulation device for the vagus nerve of the ear can realize the electrical stimulation process of the electrical stimulation device for the vagus nerve of the ear by adopting the scheme, can make up the defects of the prior art, effectively popularize the scheme of electrical stimulation for the vagus nerve by adopting medical instruments, and has very strong practicability.

The flowchart and block diagrams in the figures illustrate the architecture, functionality, and operation of possible implementations of systems and methods according to various embodiments of the present invention. It should also be noted that, in some alternative implementations, the functions noted in the block may occur out of the order noted in the figures. For example, two blocks shown in succession may, in fact, be executed substantially concurrently, or the blocks may sometimes be executed in the reverse order, depending upon the functionality involved. It will also be noted that each block of the block diagrams and/or flowchart illustration, and combinations of blocks in the block diagrams and/or flowchart illustration, can be implemented by special purpose hardware-based systems which perform the specified functions or acts, or combinations of special purpose hardware and computer instructions.

While various embodiments of the present invention have been described above, the above description is intended to be illustrative, not exhaustive, and not limited to the disclosed embodiments. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is chosen in order to best explain the principles of the embodiments, the practical application, or improvements made to the technology in the marketplace, or to enable others of ordinary skill in the art to understand the embodiments disclosed herein.

Claims (10)

1. An electrical vagus nerve stimulation device of the ear, the device comprising a stimulation module, a battery, an interactive interface and at least one pair of stimulation electrodes for stimulating the projecting region of the vagus nerve of the ear; the interactive interface is used for detecting and identifying an input control signal and determining treatment parameters according to the control signal; the battery is respectively and electrically connected with the interactive interface and the stimulation module and supplies power to the interactive interface and the stimulation module; the stimulation module is respectively electrically connected with the interaction interface and each pair of stimulation electrodes and is used for controlling each pair of stimulation electrodes to electrically stimulate the vagus nerve projecting region of the ear according to the treatment parameters.

2. The apparatus of claim 1, wherein the interactive interface is implemented by using a mechanical button, and the interactive interface comprises a switch button.

3. The device of claim 2, further comprising a status prompting light, a treatment duration adjustment button, an intensity adjustment button, and/or a pause/continue button;

the interactive interface also comprises a detection module which is respectively and electrically connected with the switch button, the treatment duration adjusting button and the intensity adjusting button;

the pause/continue button is pressed during treatment to trigger the pause of treatment; when pressed in the pause, triggers the continuation of the treatment.

4. The device of claim 1, wherein the interactive interface is implemented by using an interactive device with a touch display screen, and a switch module is disposed in the interactive device.

5. The device according to claim 4, wherein a parameter setting module and/or a mode selection module is further provided in the interaction device;

the interactive interface also comprises a detection module which is respectively and electrically connected with the switch module, the parameter setting module and the mode selection module.

6. The apparatus of claim 5, wherein the parameter setting module comprises at least one of a frequency setting unit, a voltage setting unit, a current setting unit, a wave width setting unit, a waveform setting unit, and a treatment duration setting unit.

7. The device of any of claims 1-6, wherein the at least one pair of stimulation electrodes is disposed on a substrate, and wherein the at least one pair of stimulation electrodes is configured to stimulate a first and/or a second projection of the vagus nerve of the ear.

8. The device of any of claims 1-6, wherein the at least one pair of stimulation electrodes are disposed on two substrates, and wherein one of the pair of stimulation electrodes on the substrate is configured to stimulate a first projection of the vagus nerve of the ear and the other of the pair of stimulation electrodes on the substrate is configured to stimulate a second projection of the vagus nerve of the ear.

9. The device of any one of claims 1-6, wherein said battery is a dry cell battery, a rechargeable battery or a lithium battery;

when the battery is a lithium battery, the device further comprises a charging interface electrically connected with the lithium battery.

10. The device according to any one of claims 1-6, wherein the at least one pair of stimulation electrodes is disposed on a support secured to the pinna; the stimulation module, the battery and the interactive interface are all arranged on the bracket, or one part of the stimulation module, the battery and the interactive interface is arranged on the bracket, the other part of the stimulation module, the battery and the interactive interface is arranged on an integrated body,

further, the integrated body is a wearable structural body in a collar shape or other structural bodies convenient to carry;

further, the device also comprises an earplug which is used for plugging the external auditory canal to support the bracket.

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