A method and apparatus for vagus nerve stimulation

Abstract

A vagus nerve stimulation method and device, when the user is in the exhalation stage in the respiratory information, the vagus nerve is stimulated by the pulse current, the frequency of the pulse current is 20-25 Hz, and the current intensity is 1-6 mA. From the above, the vagus nerve is stimulated by the pulse current when the user is in the exhalation stage, the regulation function of the vagus nerve and the brain is enhanced, so as to regulate the psychological state of the user, improve the psychological health of the user and promote the general cognitive function.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a vagus nerve stimulation method and device. BACKGROUND

[0002] With the increasing stress of people's life, study and work, more and more physical and mental health problems are caused, and the vagus nerve disorder, anxiety and depression, insomnia and other psychological health problems caused by stress have caused serious challenges. At the same time, the demand of individuals for improving individual psychological state and cognitive function is increasing.

[0003] In order to relieve stress, intervene depression, anxiety and other psychological health problems, people usually can only intervene and treat by drugs or psychological counseling. However, long-term drug use will cause drug dependence, and drugs will also have adverse effects on the body of individuals. Psychological counseling is also affected by the regional limitations of professional workers, and the promotion of general cognitive function in the past is more based on cognitive behavior training, which is time-consuming and laborious and the effect is limited by various factors. Therefore, a method or device is urgently needed to replace or assist drugs or psychological counseling to intervene or treat people's stress and psychological health problems, and to promote individual general cognitive function. SUMMARY

[0004] The purpose of the present application is to provide a vagus nerve stimulation method and device to relieve or treat the symptoms of insomnia and depression, and to promote individual general cognitive function.

[0005] The first aspect of the present application provides a vagus nerve stimulation method, comprising: collecting the breathing information of a user; determining that the user is in the exhalation phase according to the breathing information, and controlling to generate a pulse current to stimulate the vagus nerve of the user through the pulse current.

[0006] From the above, the vagus nerve can be stimulated by emitting a pulse current when the user is in the exhalation phase, so as to regulate the vagus nerve and the brain, thereby regulating the mental health state of the user, and further assisting the adjustment and treatment of the mental state of the user such as insomnia, stress, anxiety and depression, and improving the psychological health state of the user. At the same time, the general cognitive function of the user can also be improved.

[0007] As a possible implementation manner of the first aspect, the frequency of the pulse current includes 20-25Hz, and the current intensity includes 1-6mA.

[0008] Therefore, the frequency range and the intensity range of the pulse current are provided, so that the pulse current can more effectively stimulate the vagus nerve, thereby regulating the vagus nerve and the brain, adjusting the mental state of the user, and further assisting in adjusting and treating the mental state such as insomnia and depression of the user, improving the mental health state of the user, and promoting the general cognitive function of the user.

[0009] As a possible implementation manner of the first aspect, the sensory threshold and the pain threshold of the user are detected, the sensory threshold is a current intensity value of the pulse current when the user can feel stimulation, and the pain threshold is a current intensity value of the pulse current when the user can feel pain; the current intensity of the pulse current is controlled to be between the sensory threshold and the pain threshold and in a range of 75%-85%.

[0010] Therefore, the intensity range of the pulse current is provided, so that the pulse current can more effectively stimulate the vagus nerve within the range that the user can bear, thereby regulating the vagus nerve and the brain, adjusting the mental state of the user, and further assisting in adjusting and treating the mental state such as insomnia and depression of the user, improving the mental health state of the user, and promoting the general cognitive function of the user.

[0011] As a possible implementation manner of the first aspect, the breathing frequency of the user is guided to reach a resonant breathing frequency.

[0012] Therefore, the breathing frequency of the user is guided to reach the resonant breathing frequency, and the resonance phenomenon is generated with the heartbeat of the user, so that the amplitude of the heart rate oscillation is increased. Therefore, the adjustment effect on the mental health state of the user can be improved.

[0013] As a possible implementation manner of the first aspect, the resonant breathing frequency is kept at 4-6 times per minute.

[0014] Therefore, based on the neural regulation method of the resonant breathing and the vagus nerve stimulation, the vagus nerve inhibition control can be increased, the effect of the vagus nerve stimulation can be improved, the mental health state of the user can be improved, and the general cognitive function of the user can be promoted.

[0015] The second aspect of the present application provides a vagus nerve stimulation device, comprising: an information acquisition module, configured to acquire breathing information of a user; a stimulation module, comprising a pulse current generating device, configured to generate a pulse current to stimulate the vagus nerve of the user; and a control module, electrically connected with the information acquisition module and the stimulation module, configured to control the stimulation module to generate the pulse current when it is determined that the user is in an exhalation phase according to the breathing information.

[0016] From the above, the vagus nerve can be stimulated by the pulse current when the user is in the exhalation phase, so as to adjust the vagus nerve and the brain, adjust the mental state of the user, and further assist in adjusting and treating the mental state such as insomnia and depression of the user, improve the psychological health state of the user, and promote the general cognitive function of the user.

[0017] As a possible implementation manner of the second aspect, the frequency of the pulse current includes 20-25 Hz, and the current intensity includes 1-6 mA.

[0018] From the above, the frequency range and intensity range of the pulse current are provided, so that the pulse current can more effectively stimulate the vagus nerve, thereby adjusting the vagus nerve and the brain, adjusting the mental state of the user, and further assisting in adjusting and treating the mental state such as insomnia and depression of the user, improving the psychological health state of the user, and promoting the general cognitive function of the user.

[0019] As a possible implementation manner of the second aspect, further comprising a detection module for detecting the sensory threshold and the pain threshold of the user, the sensory threshold being the current intensity value of the pulse current when the user can feel the stimulation, and the pain threshold being the current intensity value of the pulse current when the user can feel pain; the control module is used to control the stimulation module to generate the current intensity of the pulse current, which is between the sensory threshold and the pain threshold and is in the range of 75%-85%.

[0020] From the above, the intensity range of the pulse current is provided, so that the pulse current can more effectively stimulate the vagus nerve within the range that the user can bear, thereby adjusting the vagus nerve and the brain, adjusting the mental state of the user, and further assisting in adjusting and treating the mental state such as insomnia and depression of the user, improving the psychological health state of the user, and promoting the general cognitive function of the user.

[0021] As a possible implementation manner of the second aspect, further comprising a human-computer interaction module for receiving the user's setting of the pulse current.

[0022] From the above, the user can control the device through the human-computer interaction module, so as to obtain better use effect.

[0023] As a possible implementation manner of the second aspect, further comprising a guiding module for guiding the optimal resonant breathing frequency of the user, so that the breathing frequency is kept at 4-6 times per minute to reach the resonant breathing frequency.

[0024] From the above, the effect of vagus nerve stimulation can be improved, the psychological health state of the user can be improved, and the general cognitive function of the user can be promoted.

[0025] The third aspect of the present application provides a controller, which receives respiratory information of a user; when the controller determines that the user is in an exhalation phase according to the respiratory information, the controller controls to generate a pulse current to stimulate the vagus nerve of the user through the pulse current.

[0026] According to the above, the vagus nerve can be stimulated by the pulse current when the user is in the exhalation phase, so as to regulate the vagus nerve and the brain, adjust the mental state of the user, and further assist in regulating and treating the mental state such as insomnia and depression of the user, improve the mental health state of the user, and promote the general cognitive function of the user.

[0027] As a possible implementation manner of the third aspect, the frequency of the pulse current includes 20-25 Hz, and the current intensity includes 1-6 mA.

[0028] According to the above, the frequency range and intensity range of the pulse current are provided, so that the pulse current can more effectively stimulate the vagus nerve, thereby regulating the vagus nerve and the brain, adjusting the mental state of the user, and further assisting in regulating and treating the mental state such as insomnia and depression of the user, improving the mental health state of the user, and promoting the general cognitive function of the user.

[0029] As a possible implementation manner of the third aspect, the controller controls to detect a sensory threshold and a pain threshold of the user, the sensory threshold being a current intensity value of the pulse current when the user can feel stimulation, and the pain threshold being a current intensity value of the pulse current when the user can feel pain; the controller controls the current intensity of the pulse current to be between the sensory threshold and the pain threshold, and to be in a range of 75%-85%.

[0030] According to the above, the intensity range of the pulse current is provided, so that the pulse current can more effectively stimulate the vagus nerve within the range that the user can bear, thereby regulating the vagus nerve and the brain, adjusting the mental state of the user, and further assisting in regulating and treating the mental state such as insomnia and depression of the user, improving the mental health state of the user, and promoting the general cognitive function of the user.

[0031] The fourth aspect of the present application provides a computing device, which includes a processor and a memory, the memory storing program instructions, the program instructions causing the processor to execute the method of the first aspect when executed by the processor.

[0032] The fifth aspect of the present application provides a storage medium, which stores program instructions, the program instructions causing the computer to execute the method of the first aspect when executed by the computer.

[0033] The sixth aspect of the present application provides a computer program product comprising program instructions which, when executed by a computer, cause the computer to perform the method of the first aspect.

[0034] These and other aspects of the present application will become more fully understood from the following (detailed) description of (one or more) embodiments thereof, given by way of example only. BRIEF DESCRIPTION OF DRAWINGS

[0035] Various features and aspects of the present application will be further clarified with reference to the following description of various features and the interrelationship between the various features. The drawings are merely exemplary and some features are not shown to scale, and some features may be omitted from, or additional features may be shown in, the drawings, which are intended to aid in the description of the present application. Also, combinations of the various features shown in the drawings are not intended to limit the present application. Additionally, like reference numerals refer to like elements throughout the description. The following is a detailed description of the drawings:

[0036] Figure 1 A schematic diagram of the vagus nerve stimulation device in the embodiments of the present application;

[0037] Figure 2 A schematic diagram of the vagus nerve stimulation method in the embodiments of the present application;

[0038] Figure 3 A schematic diagram of the controller of the present application;

[0039] Figure 4A A schematic diagram of the change in heart rate variability of each group before and after intervention;

[0040] Figure 4B A schematic diagram of the change in general anxiety symptoms of each group before and after intervention;

[0041] Figure 4C A schematic diagram of the change in depression symptoms of each group before and after intervention;

[0042] Figure 5A A schematic diagram of the change in cognitive function of each group before and after intervention;

[0043] Figure 5B A schematic diagram of the change in attention alert network of attention network function of each group before and after intervention;

[0044] Figure 5C A schematic diagram of the comparison of attention orientation network scores of attention network function of each group before and after intervention;

[0045] Figure 5D A schematic diagram of the comparison of executive control network scores of attention network function of each group before and after intervention;

[0046] Figure 6is a structural schematic diagram of a computing device provided by an embodiment of the present application.

[0047] Reference Signs List

[0048] 100 vagus nerve stimulation device; 110 control module; 120 information acquisition module; 130 stimulation module; 140 human-computer interaction module; 150 communication module; 160 guidance module; 300 controller; 400 computing device; 410 processor; 420 memory; 430 communication interface. DETAILED DESCRIPTION

[0049] The words "first", "second", "third", etc., or module A, module B, module C, and the like in the specification and claims are only used to distinguish similar objects, and do not represent a specific order of the objects. It can be understood that the specific order or sequence can be interchanged as permitted, so that the embodiments described herein can be implemented in an order other than that illustrated or described herein.

[0050] In the following description, the labels indicating steps such as S110, S120, etc. do not necessarily mean that the steps are executed in this order, and the order of the steps can be interchanged or executed simultaneously as permitted.

[0051] The term "comprising" used in the specification and claims should not be interpreted as limiting to the contents listed thereafter; it does not exclude other elements or steps. Therefore, it should be interpreted as specifying the existence of the mentioned features, integers, steps or components, but not excluding the presence or addition of one or more other features, integers, steps or components and groups thereof. Therefore, the expression "a device comprising means A and B" should not be limited to a device consisting only of components A and B.

[0052] The phrase "one embodiment" or "an embodiment" appearing in the specification means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the application. Therefore, the phrases "in one embodiment" or "in an embodiment" appearing throughout the specification do not necessarily all refer to the same embodiment, but can refer to different embodiments. In addition, in one or more embodiments, each particular feature, structure, or characteristic can be combined in any appropriate manner as would be apparent to one of ordinary skill in the art from this disclosure.

[0053] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the application belongs. If there is a conflict between the definitions in the specification and the meanings according to the content described in the specification, the meanings described in the specification or derived from the content described in the specification shall prevail. In addition, the terms used herein are only for the purpose of describing the embodiments of the application and are not intended to limit the application.

[0054] In order to accurately describe the technical content of this application, and in order to accurately understand this application, the following explanations or definitions are given for the terms used in this specification before describing the specific embodiments:

[0055] 1) Vagus Nerve: The vagus nerve is a mixed nerve. Its motor fibers originate from the nucleus ambiguus, run parallel to the glossopharyngeal nerve, exit the brainstem, and exit the cranial cavity through the jugular foramen. It supplies all muscles of the pharynx, larynx, and soft palate except for the soft palate and stylopharyngeal muscles. Sensory neurons are located in the cervical ganglia and tubercular ganglia near the jugular foramen. Peripheral branches of the cervical ganglia transmit some general sensations of the external auditory canal, tympanic membrane, and auricle; central branches enter the brainstem and spinal cord nuclei of the trigeminal nerve. Peripheral branches of the tubercular ganglia transmit sensations of the pharynx, larynx, trachea, esophagus, and various internal organs, as well as taste sensations of the pharynx, soft palate, hard palate, and epiglottis; central branches enter the nucleus of the solitary tract. The parasympathetic nervous system originates from the dorsal nucleus of the vagus nerve at the base of the fourth ventricle and supplies internal organs.

[0056] 2) The Erzhong acupoint, also known as the Ge acupoint, is the vagus nerve point in the ear. It is located at the midpoint between the auricle and the crus of the helix. There are two cartilages in the ear, and the Erzhong acupoint is located on the middle cartilage. Pressing the Erzhong acupoint will cause a stinging sensation.

[0057] 3) Slowing down the breathing rate and breathing at a certain rate, the phenomenon of resonance between the breathing-related heart rhythm (i.e., high-frequency oscillation, or RSA) and the heart rhythm caused by baroreceptor reflex activity (low-frequency oscillation) is called resonant breathing.

[0058] This application provides a vagus nerve stimulation device 100. The specific structure of the vagus nerve stimulation device 100 in this application embodiment will be described in detail below with reference to the accompanying drawings.

[0059] Figure 1 This is a schematic diagram illustrating the composition of the vagus nerve stimulation device 100 in an embodiment of this application. Figure 1 As shown, the vagus nerve stimulation device 100 in this embodiment includes: an information acquisition module 120, a stimulation module 130, a control module 110, a human-computer interaction module 140, a communication module 150, and a guidance module 160. The information acquisition module 120 collects the user's respiratory information; when the user is in the exhalation phase of the respiratory information, the control module 110 controls the stimulation module 130 to emit a pulsed current.

[0060] Therefore, by stimulating the vagus nerve with pulsed electrical currents during the user's exhalation phase, the vagus nerve and brain can be regulated, thereby regulating the user's mental state. This can then be used to assist in the regulation and treatment of mental states such as insomnia and depression, improving the user's mental health. Simultaneously, it can also improve the user's general cognitive function.

[0061] In some embodiments, the information collection module 120 comprises a respiration sensor for collecting respiration information.

[0062] The respiration sensor can be a force sensor, such as a pressure sensor or a tension sensor. Since the volume of the chest cavity and the abdominal cavity changes during the exhalation and inhalation of a person, the force sensor can detect the change of pressure or tension caused by the volume change of the chest cavity or the abdominal cavity to determine whether the person is in the exhalation phase, the inhalation phase or the transition phase.

[0063] The respiration sensor can also be a displacement sensor. The displacement sensor can detect the displacement of the chest cavity and the abdominal cavity caused by the volume change during the exhalation and inhalation of a person to determine whether the person is in the exhalation phase, the inhalation phase or the transition phase.

[0064] The respiration sensor can also be an airflow sensor. The airflow sensor can detect the airflow change during the exhalation and inhalation of a person to determine whether the person is in the exhalation phase, the inhalation phase or the transition phase.

[0065] In some embodiments, the information collection module 120 further comprises a fixing device. The fixing device is used to fix the respiration sensor on the human body so that the respiration sensor can detect the respiration information.

[0066] In some embodiments, when the respiration sensor is a respiration sensor for detecting the chest cavity and the abdominal cavity, the fixing device can comprise a binding belt. The above-mentioned pressure sensor, tension sensor or displacement sensor can be fixed on the chest cavity or abdominal cavity by the binding belt, so that the sensor is between the binding belt and the human body. The binding belt can be an annular elastic binding belt. The user can put the elastic binding belt on the chest side or the abdominal side, and the position of the pressure sensor is overlaid on the position of the chest cavity or the abdominal cavity.

[0067] The above-mentioned pressure sensor, tension sensor or displacement sensor can be provided separately from the binding belt. In order to facilitate the relative stability of the sensor and the binding belt when the user uses them, the sensor and the binding belt can have an assembly structure, such as a magic tape, a clamping structure, etc. In other embodiments, the sensor can be provided integrally with the binding belt.

[0068] In some embodiments, when the respiration sensor is a respiration sensor for detecting the airflow of the mouth and nose, the fixing device can comprise a breathing mask. The breathing mask can be a head-mounted type (such as a mask type, a full-coverage type), a mouth and nose covering type (such as a mouth mask type). The breathing mask has an air-permeable part (such as a breathing valve). The respiration sensor, such as an airflow sensor, is arranged at the air-permeable part. The respiration sensor can also be arranged inside the breathing mask opposite to or near the mouth and nose to detect the airflow change caused by the respiration.

[0069] In other embodiments, for the respiratory mask type of fixation device, due to the airflow of the user's breathing, the pressure in the respiratory mask will change, or the temperature in the mask will change, and a pressure sensor or a temperature sensor can also be used as a breathing sensor applied to the respiratory mask type of fixation device.

[0070] In some embodiments, when the breathing sensor uses a breathing sensor for detecting the nasal cavity breathing airflow, the fixation device can specifically include a nose clip, a patch, etc. fixation device, such as through the nose clip, the airflow sensor can be fixed at the nasal cavity outlet, or through the patch, the airflow sensor is fixed between the nasal cavity outlet and the upper lip. Similarly, a pressure sensor or a temperature sensor can also be used as a breathing sensor applied to such fixation devices.

[0071] In some embodiments, in order to more accurately detect or identify the various stages of the user's breathing, a combination of the above-mentioned various sensors can also be used to collect relevant data when the user is breathing, and the data is comprehensively detected and identified according to the data.

[0072] In some embodiments, the stimulation module 130 includes a pulse current generating device and a transmitting head connected to the pulse current generating device. The pulse current generating device generates a pulse current according to the control of the control module 110. The transmitting head is used to act on the vagus nerve position of the human body.

[0073] In some embodiments, the frequency of the pulse current is 20-25 HZ.

[0074] In some embodiments, the pulse width of the pulse current is 250 microseconds.

[0075] In some embodiments, the current intensity of the pulse current is at least 1 mA.

[0076] In some embodiments, the current intensity of the pulse current is at most 4-6 mA.

[0077] In some embodiments, the duration of the pulse current is a first length. The first length can be, for example, 30 minutes.

[0078] In some embodiments, the pulse current is a rectangular, biphasic, or symmetrical pulse.

[0079] In some embodiments, the pulse current is 1000 microseconds per phase, and the interphase interval is 30 microseconds.

[0080] In some embodiments, the current intensity of the pulse current is between the sensory threshold and the pain threshold, in the range of 75%-85%, the sensory threshold is the intensity value that can feel the stimulation, and the pain threshold is the intensity value that can feel the pain of the stimulation.

[0081] In some embodiments, the emitting heads of the stimulation module 130 can be arranged on the neck, chest or head of the human body when in operation, according to the location of the vagus nerve to be stimulated.

[0082] In some embodiments, when the vagus nerve to be stimulated is located on the head, a head-mounted device can be further included, and the emitting heads of the stimulation module 130 are fixed in the head-mounted device. The pulse current emitting heads can be electrodes protruding towards the head, and the electrodes can match the location of the vagus nerve on the head.

[0083] In some embodiments, when the vagus nerve to be stimulated is located on the ear, for example, the vagus nerve superficial branch distributed in the auricular point and / or the concha and external auditory canal (auricular point visceral area), an ear clamping device can be further included. The ear clamping device can include a fixing part sleeved on the auricle and a part extending into the ear to contact the auricular point. The pulse current emitting heads are arranged on the part, and the pulse current emitting heads can be protruding electrodes. In some embodiments, when the vagus nerve to be stimulated is located on the neck, a neck clamping device can be further included. The neck clamping device can include two contact parts contacting the two sides of the neck. The two contact parts are connected by a flexible part around the neck. The pulse current emitting heads are arranged on the side of the two contact parts facing the neck, and the pulse current emitting heads can be protruding electrodes. In other embodiments, the two contact parts can also be fixed in a similar neck collar manner.

[0084] In some embodiments, when the vagus nerve to be stimulated is located on the skin of the neck, chest, abdomen or other parts of the body, a plurality of patches can be further included, which are attached to the skin surface. For example, the patches can be made of silicone material, and the pulse current emitting heads can be arranged on the side of the patches facing the skin. The pulse current emitting heads can be protruding electrodes.

[0085] In some embodiments, the control module 110 can include a microcontroller, such as a single-chip microcomputer. The control module 110 is connected with the respiration sensor, receives the signal of the respiration sensor, and determines the expiration phase. The stimulation device is controlled to work in the expiration phase.

[0086] In some embodiments, the control module 110 can identify the expiration phase according to the periodic change of the signal of the respiration sensor, and control the stimulation device to work in the expiration phase.

[0087] In some embodiments, the microcontroller is connected with a communication module 150, or the microcontroller is built-in with a communication module 150, which is used for communication connection with a computer or a mobile phone and other external devices.

[0088] In some embodiments, the communication module 150 can include a wired communication unit and / or a wireless communication unit.

[0089] The wired communication unit can be, for example, a USB interface, and the wireless communication unit can be a Bluetooth subunit or a WIFI subunit. Thus, the communication module 150 can be connected to a mobile phone, a computer, or the like. When the mobile phone or the computer has a corresponding APP, the control module 110 can be controlled by sending instructions to the control module 110 through the corresponding APP.

[0090] In some embodiments, the user can issue a stimulation instruction through the APP during his own exhalation phase, and terminate the stimulation instruction before the end of the exhalation phase.

[0091] In some embodiments, the human-computer interaction module 140 can include a touch display screen, physical buttons, a loudspeaker, a remote control, and the like. The user can control the human-computer interaction module 140 according to needs to select the required functions and parameters.

[0092] In some embodiments, the pulsed current forms a density wave, the frequency of the density wave is 20 Hz, and the wave width is less than 1 ms. The intensity of the stimulation is adjusted according to the tolerance of the patient (4-6 mA). Each treatment lasts for 30 minutes, and is performed twice a day, at least 5 days a week, for a treatment period (4 weeks) to relieve mild or moderate depression.

[0093] In some embodiments, a current with a frequency of 25 Hz is provided to stimulate the vagus nerve for a total effective duration of 12 minutes, which can maintain a high level of wakefulness for 34 hours and perform a plurality of simulated tasks during the period.

[0094] In some embodiments, a stimulation with a stimulation intensity of 0.5 mA, a pulse width of 200-300 ms at 25 Hz, a duration of 30 seconds, and a rest of 30 seconds enhances the action control ability of the subject.

[0095] In some embodiments, a sparse and dense wave with a pulse frequency of 20 Hz, a wave width of ≤1 ms, and a current of 1 mA that gradually increases in intensity according to the tolerance without causing pain is provided. The stimulation produces similar brain effects as previous implanted vagus nerve stimulation studies, and produces a wide range of modulation of the limbic-paralimbic system.

[0096] In some embodiments, a constant voltage device is further included, and the constant voltage device provides a continuous output current, the pulse is a continuous wave, the frequency is 20 Hz, the wave width is 0.2 ms, the electric stimulation intensity is a pain threshold current that is comfortable for the patient to tolerate and does not cause pain, the current is measured at the time before the scanning experiment, and the current is generally 4-8 mA. The average vagus nerve stimulation current of the normal subjects in the experiment is 6.44 mA (4-10 mA), and the average of the control group is 6.8 mA (5-10 mA). It is inferred that the stimulation can mediate the treatment effect of various diseases such as refractory epilepsy and depression through the solitary nucleus-marginal lobe brain network.

[0097] In some embodiments, a stimulation with an intensity of 1 mA, a frequency of 20-30 Hz, and a pulse time of ≤1 ms is provided, and the Ta-VNS treatment is performed once every 4 weeks during the treatment, and the clinical symptoms of patients with mild and moderate depression are improved, and the quality of life is obviously improved. The treatment effect of the ear concha vagus nerve stimulation site is better than that of the ear rim (non-ear concha vagus nerve) stimulation site, and the treatment effect gradually becomes better as the treatment course increases.

[0098] In some embodiments, a stimulation with a frequency of 20 Hz, an output current of 1-10 mA (250 Ω load impedance), an output power of 0.1-0.3 VA (250 Ω load impedance), and a pulse width of 0.2 ms±30% is provided, and the treatment course is timed for 30 min, which can improve the cure efficiency of depression and improve the cure effect on patients.

[0099] In some embodiments, the guiding module 160 can guide the user's breathing frequency in the form of text, pictures, animations, or sound, and preferably guides the user's breathing frequency to reach the resonant breathing frequency, and specifically, the breathing frequency can be maintained at 4-6 times / minute.

[0100] Further, the user's breathing frequency is guided, and preferably guided between the stimulation of the user's vagus nerve by the stimulation module 130, so that the user maintains a breathing frequency of 4-6 times / minute during the entire stimulation process of the stimulation module 130. It can also be guided when the stimulation module 130 stimulates the user's vagus nerve, which is not limited.

[0101] The embodiment of the present application further provides a vagus nerve stimulation method 200, and the vagus nerve stimulation method 200 in the embodiment of the present application can be implemented by the vagus nerve stimulation device 100 or other suitable devices, which is not limited. The specific steps of the vagus nerve stimulation method 200 in the embodiment of the present application are described in detail below with reference to the accompanying drawings.

[0102] Figure 2A flowchart of a vagus nerve stimulation method 200 in an embodiment of the present application is shown. As shown, the specific flow of the vagus nerve stimulation method 200 in the embodiment of the present application includes: Figure 2

[0103] In step S201, the breathing frequency is adjusted.

[0104] The breathing frequency of the user can be guided in the form of text, pictures, animations, or sound, so that the breathing frequency reaches the resonant breathing frequency. Specifically, the breathing frequency can be maintained at 4-6 times per minute.

[0105] In step S202, the breathing information is collected.

[0106] In step S203, when the person is in the exhalation phase in the breathing information, the pulse current is emitted.

[0107] In this way, the vagus nerve can be stimulated by emitting a pulse current when the person is in the exhalation phase, so as to adjust the vagus nerve and the brain, thereby adjusting the mental state of the person, and further assisting in adjusting and treating the mental state such as insomnia and depression of the person.

[0108] In some embodiments, the frequency of the pulse current is 20-25 HZ.

[0109] In some embodiments, the pulse width of the pulse current is 250 microseconds.

[0110] In some embodiments, the current intensity of the pulse current is at least 1 mA.

[0111] In some embodiments, the current intensity of the pulse current is at most 4-6 mA.

[0112] In some embodiments, the duration of the pulse current is a first duration. The first duration can be, for example, 30 minutes.

[0113] In some embodiments, steps S204 and S205 are further included.

[0114] In step S204, after the pulse current lasts for the first duration, the emission of the pulse current is stopped.

[0115] In step S205, after the emission of the pulse current is stopped for a second duration, the pulse current is emitted again.

[0116] In some embodiments, step S206 is further included.

[0117] In step S206, the pulse current is emitted again for a third duration.

[0118] ​The embodiment of the present application also provides a control method, specifically comprising: receiving breathing information, and sending first control information when a person is in an exhalation phase in the breathing information, the first control information being used for controlling sending of a pulse current.

[0119] Therefore, the vagus nerve can be stimulated by sending the pulse current when the person is in the exhalation phase, so as to regulate the vagus nerve and the brain, thereby regulating the mental state of the person, and further assisting in regulating and treating the mental state such as insomnia and depression of the person, and improving the mental health state of the user. Meanwhile, the general cognitive function of the user can also be improved.

[0120] In some embodiments, the first control information is specifically used for controlling the frequency of the pulse current to be 20-25 HZ.

[0121] In some embodiments, the first control information is specifically used for controlling the pulse width of the pulse current to be 250 microseconds.

[0122] In some embodiments, the first control information is specifically used for controlling the current intensity of the pulse current to be at least 1 mA.

[0123] In some embodiments, the first control information is specifically used for controlling the current intensity of the pulse current to be at most 4-6 mA.

[0124] In some embodiments, after the pulse current is sent for a first duration, second control information is sent, the second control information being used for controlling stopping sending of the pulse current.

[0125] In some embodiments, the first duration can be, for example, 30 minutes.

[0126] In some embodiments, after the pulse current is stopped for a second duration, third control information is sent, the third control information being used for controlling sending of the pulse current again.

[0127] In some embodiments, after the pulse current is sent again for a third duration, fourth control information is sent, the fourth control information being used for controlling stopping sending of the pulse current again.

[0128] The embodiment of the present application also provides a controller 300, the function of the controller 300 can be realized by a processor executing a program (software), in addition, the function of the controller 300 can also be realized by LSI (Large Scale Integration, large scale integrated circuit) and ASIC (Application Specific Integrated Circuit, application specific integrated circuit) and the like hardware, or the function of the controller 300 can also be realized by a combination of software and hardware.

[0129] Figure 3 The controller 300 in the embodiment of the present application is shown in FIG. 3. As shown in FIG. 3, the controller 300 can include a processor 301, a memory 302, a communication interface 303, and a power supply 304.Figure 3 As shown, the controller 300 in the embodiment of the present application comprises: receiving breathing information by the controller 300, when the person in the exhalation phase in the breathing information, the controller 300 sends the first control information, the first control information is used to control the sending of the pulse current.

[0130] Thus, the vagus nerve can be stimulated by sending a pulse current when the person is in the exhalation phase, thereby regulating the vagus nerve and the brain, thereby adjusting the mental state of the person, and further assisting in adjusting and treating the mental state of the person such as insomnia, depression, etc.

[0131] In some embodiments, the first control information is specifically used to control the frequency of the pulse current to be 20-25HZ.

[0132] In some embodiments, the first control information is specifically used to control the pulse width of the pulse current to be 250 microseconds.

[0133] In some embodiments, the first control information is specifically used to control the current intensity of the pulse current to be at least 1mA.

[0134] In some embodiments, the first control information is specifically used to control the current intensity of the pulse current to be at most 4-6mA.

[0135] In some embodiments, after sending the pulse current for a first duration, the controller 300 sends the second control information, and the second control information is used to control to stop sending the pulse current.

[0136] In some embodiments, the first duration can be, for example, 30 minutes.

[0137] In some embodiments, after stopping sending the pulse current for a second duration, the controller 300 sends the third control information, and the third control information is used to control to send the pulse current again.

[0138] In some embodiments, after sending the pulse current again for a third duration, the controller 300 sends the fourth control information, and the fourth control information is used to control to stop sending the pulse current again.

[0139] In some embodiments, the controller 300 also sends the fifth control information, and the fifth control information is used to control to send the guidance information, which can guide the user to adjust the breathing frequency, preferably, the user can keep the breathing frequency at 4-6 times per minute according to the guidance information.

[0140] Next, combined with specific experimental data, the changes of the user in the aspects of anxiety and depression psychological health and cognitive function, etc. after being adjusted by the vagus nerve stimulation method and device in the embodiment of the present application are compared and explained.

[0141] I. Comparison and explanation of the effect of anxiety and depression mental health intervention.

[0142] We adopted 125 anxiety and depression risk population college students (using anxiety and depression evaluation tools GAD, PHQ, individuals exceeding the cut-off score), randomly divided into 5 groups, as follows:

[0143] 1. Experiment 1 group, using the vagus nerve stimulation method and device in the embodiment to adjust the user. Specifically, using the combination of resonant slow expiration gating and transcutaneous vagus nerve stimulation (tVNS)

[0144] The user is guided to adjust the breathing frequency, and the breathing frequency is controlled at 4-6 times / minute, and the transcutaneous vagus nerve is stimulated during the expiration phase.

[0145] 2. Experiment 2 group, using the vagus nerve stimulation method and device in the embodiment to adjust the user. Specifically, using the combination of expiration gating and transcutaneous vagus nerve stimulation for adjustment. That is, the user stimulates the transcutaneous vagus nerve during the expiration phase under normal breathing frequency.

[0146] 3. Single factor training 1 group, guiding the user to adjust the breathing frequency, and controlling the breathing frequency at 4-6 times / minute.

[0147] 4. Single factor training group 2, without adjusting the breathing, directly stimulating the transcutaneous vagus nerve.

[0148] 5. Control group, without adjusting the breathing, stimulating the pseudo vagus nerve.

[0149] The above 5 groups of students are controlled and trained for 14 days, once a day for half an hour, the heart rate variability index of the individual is monitored at the baseline level and after the training is completed, and the subjective psychological measurement index of anxiety and depression is evaluated, and the following data is obtained.

[0150] Figure 4A The heart rate variability change diagram of each group before and after intervention is shown, which shows the HF-HRV (high frequency heart rate variability) score change of each group before and after intervention. According to the data HF-HRV-1 and data HF-HRV-2 in table 1, after training, experiment 1 group and experiment 2 group have a significant increase in heart rate variability (especially high frequency heart rate variability), and the improvement difference is significantly different from other groups. And the effect of experiment 1 group is significantly better than other 4 groups.

[0151]

[0152] Table 1

[0153] Figure 4B Figure 2 shows the changes in GAD scores in each group before and after the intervention. Figure 4C Figure 3 shows the changes in PHQ scores in each group before and after the intervention. Table 1 shows the comparison of heart rate variability and scores of anxiety and depression indicators in each group before and after the intervention. In terms of subjective psychological measurement, we found that both the experimental group 1 using resonant slow exhalation gating and transcutaneous vagus nerve stimulation and the experimental group 2 using exhalation gating and transcutaneous vagus nerve stimulation had significant reduction in anxiety indicators of GAD and depression indicators of PHQ. The reduction difference was significantly different from other groups. The effect of the experimental group 1 was significantly better than that of the other four groups.

[0154] II. Comparison and explanation of the intervention effect on individual cognitive function.

[0155] We used 125 healthy junior three students, who were randomly divided into five groups as follows:

[0156] 1. The experimental group 1 used the vagus nerve stimulation method and device in the present application to adjust the user. Specifically, the resonant slow exhalation gating and transcutaneous vagus nerve stimulation were combined to adjust the user. That is, the user was guided to adjust the breathing frequency, and the breathing frequency was controlled at 4-6 times per minute, and the transcutaneous vagus nerve was stimulated during the exhalation phase.

[0157] 2. The experimental group 2 used the vagus nerve stimulation method and device in the present application to adjust the user. Specifically, the exhalation gating and transcutaneous vagus nerve stimulation were combined to adjust the user. That is, the user was guided to adjust the breathing frequency, and the breathing frequency was controlled at 4-6 times per minute, and the transcutaneous vagus nerve was stimulated during the exhalation phase.

[0158] 3. The single factor training group 1 guided the user to adjust the breathing frequency, and the breathing frequency was controlled at 4-6 times per minute.

[0159] 4. The single factor training group 2 did not adjust the breathing, and directly stimulated the transcutaneous vagus nerve.

[0160] 5. The control group did not adjust the breathing, and stimulated the pseudo vagus nerve.

[0161] The control training was carried out for 14 days, once a day, for half an hour, in the real chronic stress environment of the middle school examination preparation, and the working memory cognitive function (measured by the classical 2-back paradigm) and the attention cognitive function (measured by the attention network: the attention alert network, the attention directional network and the executive control network were respectively evaluated by the classical attention network test (ANT)) of the individual were monitored at the baseline and after the experiment, and the following data were obtained.

[0162]

[0163] Table 2

[0164] Figure 5A The cognitive function change diagram before and after the intervention of each group is shown, and the 2-back reaction time data before and after the intervention of each group are shown. Figure 5B The attention alert network change diagram of the attention network function before and after the intervention of each group is shown. Figure 5C The attention directional network score comparison diagram of the attention network function before and after the intervention of each group is shown. Figure 5D The executive control network score comparison diagram of the attention network function before and after the intervention of each group is shown. Table 2 is the comparison of the cognitive function index scores of each group before and after the intervention.

[0165] According to Figures 5A-5D and Table 2, it can be found that the working memory cognitive function of the experiment 1 group (using slow resonance expiratory gating + transcutaneous vagus nerve stimulation) and the experiment 2 group (using expiratory gating + transcutaneous vagus nerve stimulation) is significantly improved before and after the intervention, and the improvement index of the experiment 1 group is significantly better than that of the other groups. Moreover, the executive control network score of the attention cognitive function of the experiment 1 group and the experiment 2 group is significantly reduced, indicating that the cognitive function is significantly improved, and the improvement index of the experiment 1 group is significantly better than that of the other groups. The attention alert network score of the experiment 1 group and the experiment 2 group is significantly improved, and the improvement index of the experiment 1 group is significantly better than that of the other groups, indicating that the attention alert network function is improved, and the attention directional network attention cognitive function index is not found to be significantly different. Figure 6 is a structural schematic diagram of a computing device 400 provided by an embodiment of the present application. The computing device 400 includes a processor 410, a memory 420, and a communication interface 430.

[0166] It should be understood that Figure 6 The communication interface 430 in the computing device 400 shown can be used for communication with other devices.

[0167] The processor 410 can be connected with the memory 420. The memory 420 can be configured to store the program code and data. Therefore, the memory 420 can be a storage unit inside the processor 410, or can be an external storage unit independent of the processor 410, or can be a component including the storage unit inside the processor 410 and the external storage unit independent of the processor 410.

[0168] It should be understood that the processor 410 can be a central processing unit (CPU) in the embodiments of the present application. The processor can also be other general-purpose processors, digital signal processors (DSP), application specific integrated circuits (ASIC), field programmable gate arrays (FPGA) or other programmable logic devices, discrete gates or transistor logic, discrete hardware components, etc. The general-purpose processor can be a microprocessor or the processor can also be any conventional processor. Alternatively, the processor 410 can be one or more integrated circuits used to execute related programs to implement the control method provided by the embodiments of the present application.

[0169] The memory 420 can include a read-only memory and a random access memory, and provide instructions and data for the processor 410. A portion of the processor 410 can also include a non-volatile random access memory. For example, the processor 410 can also store device type information.

[0170] When the computing device 400 is running, the processor 410 executes the computer-executable instructions in the memory 420 to perform the operation steps of the above method.

[0171] It should be understood that the computing device 400 according to the embodiments of the present application can correspond to the execution of the corresponding subject in the method according to the embodiments of the present application, and the above and other operations and / or functions of each module in the computing device 400 are respectively for implementing the corresponding flow of each method of the embodiments, and for brevity, will not be repeated here.

[0172] Those skilled in the art can appreciate that the units and algorithm steps of the examples described in conjunction with the embodiments disclosed herein can be implemented in electronic hardware, or a combination of computer software and electronic hardware. Whether the functions are implemented in hardware or software depends on the specific application and design constraints of the technical solution. Those skilled in the art can use different methods to implement the described functions for each specific application, but such implementation should not be considered beyond the scope of the present application.

[0173] Those skilled in the art can clearly understand that, for the convenience and brevity of description, the specific working processes of the above-described system, device and unit can refer to the corresponding processes in the foregoing method embodiments, which will not be repeated here.

[0174] In several embodiments provided in the present application, it should be understood that the disclosed system, device and method can be implemented in other manners. For example, the described device embodiments are merely schematic, and the division of the units is merely a logical function division, and there can be another division manner in actual implementation, for example, a plurality of units or components can be combined or integrated into another system, or some features can be ignored or not executed. In addition, the displayed or discussed mutual couplings or direct couplings or communication connections can be indirect couplings or communication connections through some interfaces, devices or units, and can be electrical, mechanical or other forms.

[0175] The units described as separate components can or can not be physically separate, and the components displayed as units can or can not be physical units, that is, can be located in one place, or can be distributed on a plurality of network units. Some or all of the units can be selected according to actual needs to achieve the purpose of the embodiment scheme.

[0176] In addition, each functional unit in the embodiments of the present application can be integrated in one processing unit, or each unit can be a physically independent unit, or two or more units can be integrated in one unit.

[0177] If the functions are implemented in the form of software function units and sold or used as independent products, they can be stored in a computer readable storage medium. Based on such understanding, the technical solutions of the present application essentially or the parts of the technical solutions that make contributions to the prior art or the parts of the technical solutions can be embodied in the form of a software product. The computer software product is stored in a storage medium, and includes a plurality of instructions for causing a computer device (which can be a personal computer, a server, or a network device, etc.) to execute all or part of the steps of the methods described in the embodiments of the present application. The foregoing storage medium includes: a U disk, a mobile hard disk, a read-only memory (ROM), a random access memory (RAM), a magnetic disk or an optical disk, and various media that can store program codes.

[0178] The embodiments of the present application also provide a computer readable storage medium, which stores a computer program. The program is executed by a processor to perform a diversified problem generation method. The method includes at least one of the schemes described in the foregoing embodiments.

[0179] The computer storage media of embodiments of the application can include any combination of one or more computer readable media. The computer readable media can be a computer readable signal medium or a computer readable storage medium. A computer readable storage medium can be, for example, but not limited to, an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system, apparatus, or device, or any suitable combination of the foregoing. More specific examples (a non-exhaustive list) of the computer readable storage medium include an electrical connection having one or more wires, a portable computer diskette, a hard disk, a random access memory (RAM), a read-only memory (ROM), an erasable programmable read-only memory (EPROM or Flash memory), an optical fiber, a portable compact disc read-only memory (CD-ROM), an optical storage device, a magnetic storage device, or any suitable combination of the foregoing. In the context of this document, a computer readable storage medium can be any tangible medium that can contain, or store a program for use by or in connection with an instruction execution system, apparatus, or device.

[0180] A computer readable signal medium can include a propagated data signal with computer readable program code embodied therein, for example, in baseband or as part of a carrier wave. Such a propagated signal can take any of a variety of forms, including, but not limited to, electro-magnetic, optical, or any suitable combination thereof. A computer readable signal medium can be any computer readable medium that is not a computer readable storage medium and that can communicate, propagate, or transport a program for use by or in connection with an instruction execution system, apparatus, or device.

[0181] Program code embodied on a computer readable medium can be transmitted using any appropriate medium, including but not limited to wireless, wireline, optical fiber cable, RF, etc., or any suitable combination of the foregoing.

[0182] Computer program code for carrying out operations of the present application can be written in any combination of one or more programming languages, including an object oriented programming language such as Java, Smalltalk, C++ or the like and conventional procedural programming languages, such as the "C" programming language or similar programming languages. The program code can execute entirely on the user's computer, partly on the user's computer, as a stand-alone software package, partly on the user's computer and partly on a remote computer or entirely on the remote computer or server. In the latter scenario, the remote computer can be connected to the user's computer through any type of network, including a local area network (LAN) or a wide area network (WAN), or the connection can be made to an external computer (for example, through the Internet using an Internet Service Provider). In some embodiments of the application, electronic mail (email) can be utilized as the

[0183] Note that the above merely describes preferred embodiments of the present application and the applied technical principles. Those skilled in the art will understand that the present application is not limited to the specific embodiments described herein, and that various obvious changes, modifications and substitutions can be made by those skilled in the art without departing from the scope of the present application. Therefore, although the present application has been described in detail through the above embodiments, the present application is not limited to the above embodiments, and can include more other equivalent embodiments without departing from the concept of the present application, and all of them belong to the protection scope of the present application.

Claims

1. A controller characterized by comprising: The method comprises the following steps: The controller receives the breathing information of the user; When the controller determines that the user is in the exhalation phase according to the breathing information, the controller sends the first control information, which is used to control the generation of the pulse current and the stimulation of the vagus nerve of the user by the pulse current; the first control information is used to control the frequency of the pulse current to be 20-25 Hz and the current intensity to be 1-6 mA; after the pulse current is sent for the first duration, the controller sends the second control information, which is used to control the stop of the sending of the pulse current; after the stop of the sending of the pulse current for the second duration, the controller sends the third control information, which is used to control the resending of the pulse current; after the resending of the pulse current for the third duration, the controller sends the fourth control information, which is used to control the resending of the pulse current; the controller also sends the fifth control information, which is used to guide the breathing frequency of the user to reach the resonant breathing frequency, and the resonant breathing frequency is kept at 4-6 times per minute; The controller controls the detection of the sensory threshold and the pain threshold of the user, the sensory threshold is the current intensity value of the pulse current when the user can feel the stimulation, and the pain threshold is the current intensity value of the pulse current when the user can feel pain; The first control information is used to control the current intensity of the pulse current, which is 75%-85% of the sum of the sensory threshold and the pain threshold.

2. A vagus nerve stimulation device, characterized by, The method comprises the following steps: An information acquisition module is used to acquire the breathing information of the user; A stimulation module comprises a pulse current generation device and is used to generate the pulse current and stimulate the vagus nerve of the user; the frequency of the pulse current is 20-25 Hz, and the current intensity is 1-6 mA; A control module is electrically connected with the information acquisition module and the stimulation module and is used to control the stimulation module to generate the pulse current and terminate the stimulation before the end of the exhalation phase of the user when the user is in the exhalation phase according to the breathing information; after the pulse current is sent for the first duration, the second control information is sent, which is used to control the stop of the sending of the pulse current; after the stop of the sending of the pulse current for the second duration, the third control information is sent, which is used to control the resending of the pulse current; after the resending of the pulse current for the third duration, the fourth control information is sent, which is used to control the resending of the pulse current; A guide module is used to guide the breathing frequency of the user to reach the resonant breathing frequency, and the resonant breathing frequency is kept at 4-6 times per minute; A detection module is used to detect the sensory threshold and the pain threshold of the user, the sensory threshold is the intensity value of the stimulation that the user can feel, and the pain threshold is the intensity value of the pain that the user can feel; the control module is used to control the current intensity of the pulse current generated by the stimulation module, which is 75%-85% of the sum of the sensory threshold and the pain threshold; A human-computer interaction module is used to receive the setting of the pulse current by the user.

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