TWI773436B - Percutaneous auricle stimulation equipment - Google Patents

Abstract

A percutaneous auricle stimulation equipment includes an electrical stimulation device wearable on one of two ears of a user, and a physiological status monitoring device. The electrical stimulation device includes an electrode module adaptive to be attached to the ear, and an electrical stimulation control module in signal connection to the electrode module. The electrical stimulation control module can be triggered to control the electrode module to provide transcutaneous electrical stimulation on the ear. The physiological status monitoring device include a sensor module adaptive to sense physiological signals of the user, and an analyzing module adaptive to analyze the physiological signals according to a balance condition of autonomic nervous system of the user. The physiological status monitoring device can automatically analyze the condition of the autonomic nervous system of the user at any time and then provide appropriate electrical stimulation when the lower function of parasympathetic nervous system or the hyperfunction of sympathetic nervous system , so that the autonomic nervous system of the user is kept in balance.

Description

Auricle percutaneous nerve stimulator

The present invention relates to a medical aid, in particular to an auricle percutaneous nerve stimulator for the ear.

The ear is the only part of the body where the parasympathetic nerves are close to the body surface. The parasympathetic nerves in the ear can be stimulated by electrical stimulation to stimulate the activity of the parasympathetic nerves, thereby promoting the balance between the sympathetic nerves and the parasympathetic nerves.

However, the current electrical stimulators used in the ear can only simply give electrical stimulation, and cannot evaluate the therapeutic effect of electrical stimulation according to the physiological state of the user being treated at any time during the electrical stimulation treatment.

Accordingly, it is an object of the present invention to provide an auricle percutaneous nerve stimulator that ameliorates at least one of the disadvantages of the prior art.

Therefore, the auricle percutaneous nerve stimulator of the present invention is suitable to be worn on the ear of a user. The auricle percutaneous nerve stimulator includes an electrical stimulation device and a physiological monitoring device. The electrical stimulation device includes a casing mechanism for hanging on the user's ear, at least one electrode module exposed outside the casing mechanism and used to abut against the ear, and an electrode module disposed on the ear An electrical stimulation control module in the housing mechanism and signally connected to the at least one electrode module, the electrical stimulation control module can be triggered and activated by a trigger signal, and an electrical stimulation is applied to the ear through the at least one electrode module . The physiological monitoring device is signal-connected to the electrical stimulation control module, including a sensing module disposed on the user and capable of measuring a physiological signal of the user, and a sensing module capable of analyzing an autonomic nervous balance condition The analysis module of the physiological signal, the analysis module generates the trigger signal when the physiological signal is determined to be low parasympathetic nerve activity and/or sympathetic nerve hyperactivity.

The effect of the present invention is that the physiological monitoring device can be used to automatically analyze and judge the current autonomic nervous balance state of the user at any time, and when the parasympathetic nerve activity is low and/or the sympathetic nerve is hyperactive, the design of appropriate electrical stimulation can help The user maintains a state of autonomic balance at all times.

Referring to FIGS. 1 and 2 , an embodiment of the auricle percutaneous nerve stimulator 200 of the present invention is suitable to be worn on the ear 900 of a user, and can be used to measure the physiological signals of the user, and according to the measured physiological signals Based on the analysis result of the physiological signal, the user's ear 900 is given electrical stimulation and sound stimulation in a timely manner, so as to stimulate the activity of parasympathetic nerves, promote the balance between sympathetic nerves and parasympathetic nerves, that is, promote the balance of autonomic nerves. In addition, the auricle percutaneous nerve stimulator 200 can also be connected to a remote control device 800 through signals of various known wireless communication technologies, and can be remotely controlled by the remote control device 800 . The remote control device 800 is, for example, but not limited to, computer equipment such as desktop computers and notebook computers, and mobile devices such as tablet computers and mobile phones. Since the wireless communication methods between the auricle percutaneous nerve stimulator 200 and the remote control device 800 are numerous and are existing technologies, such as wireless network technologies such as wifi and bluetooth, and mobile communication technologies such as 4G and 5G, the details are not detailed here. stated

The auricle percutaneous nerve stimulator 200 includes an electrical stimulation device 3 to be worn on the user's ear 900 , an electrical stimulation device 3 mounted on the electrical stimulation device 3 and used to abut against the user's body surface. The monitoring device 4 and a sound output device 5 of the physiological monitoring device 4 are connected with a signal.

Referring to FIGS. 2 , 3 and 4 , the electrical stimulation device 3 includes a housing mechanism 31 to be worn on the user’s ear 900 (shown in FIG. 1 ), and a plurality of electrode molds mounted on the housing mechanism 31 . A group 32 , and an electrical stimulation control module 33 installed in the housing mechanism 31 and signally connected to the electrode modules 32 . The casing mechanism 31 includes a casing body 311 and a curved rod-shaped ear-hanging rod 312 disposed on the casing body 311 and used for hooking on the ear portion 900 . Since there are many types of casing mechanisms 31 that can be hooked and worn on the ear portion 900 , the implementation is not limited to the drawings.

Referring to FIGS. 1 , 5 and 6 , the electrode modules 32 are arranged to be exposed on one side of the shell body 311 close to the ear portion 900 . In this embodiment, there are three electrode modules 32 , two of which are arranged. The group 32 is used for elastically pressing against the ear portion 900 , and the other electrode module 32 is used for clamping against the ear portion 900 .

Each electrode module 32 for elastically pressing against the surface of the ear portion 900 includes an electrode seat 321 penetrating the shell body 311 flexibly and displaceably, and two electrode seats 321 disposed at intervals at the end of the electrode seat 321 for contacting The electrode 322 abutting against the ear portion 900 , and an elastic member 323 disposed and positioned in the case body 311 and resiliently abutting between the case body 311 and the electrode seat 321 . The electrode holder 321 can be pushed and retracted into the shell body 311 to elastically compress the elastic member 323. The elastic member 323 always elastically pushes the electrode holder 321 toward the outside of the casing body 311, so that the electrode holder 321 drives the The electrodes 322 elastically abut against the elastic force of the ear portion 900 .

The electrode module 32 for elastically clipping against the ear portion 900 includes a clip 324 pivotally pivoted on the shell body 311 relative to the shell body 311 , and two clips 324 and 324 , respectively. The electrode 322 of the shell body 311 and an elastic member 323 ′ disposed between the clip 324 and the shell body 311 . The clip 324 has an operation portion 325 and a clip portion 326 located on opposite sides of the pivot axis in the radial direction. The clip portion 326 is provided with the corresponding electrode 322, and the elastic member 323' always has the ability to drive the clip 323. The abutting portion 326 of the clip 324 swings against the shell body 311 , so that the abutting portion 326 and the shell body 311 elastically clamp against the elastic force of the ear portion 900 , in addition, the elastic member 323 ′ also drives The electrode 322 disposed on the abutting portion 326 is displaced toward the other electrode 322 disposed on the shell body 311 , so that the electrodes 322 are clamped against each other and contact the ear portion 900 .

In the present embodiment, the electrode modules 32 are designed to be able to touch specific acupoints of the ear 900 , such as but not limited to the tragus, the concha cavity and the concha boat of the ear 900 . Wait for the acupuncture points that exist in the three areas.

2, 4 and 6, the electrical stimulation control module 33 is electrically connected to the electrodes 322 of the electrode modules 32, and has a plurality of built-in electrical stimulation modes that can be switched and set, which will be controlled by the remote control device A mode setting signal sent by 800 controls to switch to one of the electrical stimulation modes, set the electrical stimulation intensity of the one of the electrical stimulation modes, and set the electrode module 32 to output the electrical stimulation signal. The electrical stimulation control module 33 can also be triggered by a trigger signal generated by the physiological monitoring device 4 to activate the set electrical stimulation mode and apply the electrical stimulation to the ear 900 through each corresponding electrode module 32 Electrical stimulation corresponding to electrical stimulation intensity.

In this embodiment, the electrical stimulation modes built in the electrical stimulation control module 33 are respectively a continuous electrical stimulation mode, an intermittent electrical stimulation mode, and a random electrical stimulation mode. When the continuous electrical stimulation mode is activated, an electrical stimulation signal will be continuously output through each electrode module 32 that is set. The electrical stimulation signal is a single-phase square wave pulse signal with a width of 200 μsec and a frequency of 30 Hz. When the intermittent electrical stimulation mode is activated, an electrical stimulation signal will be output intermittently through each electrode module 32 that is set. The electrical stimulation signal is a single-phase square wave with a width of 200 μsec and a frequency of 30 Hz. 5 seconds, 5 seconds pause. When the random number electrical stimulation mode is activated, an electrical stimulation signal will be continuously outputted through each electrode module 32 that is set. The electrical stimulation intensity generated by the electrical stimulation signal controls the electrical stimulation intensity to the set value.

1, 2, and 4, the physiological monitoring device 4 includes a sensing module 41 for measuring the physiological signals of the human body against the body surface, and a sensing module 41 disposed in the housing body 311 and connected to the sensing signal The module 41 and the analysis module 42 of the electrical stimulation control module 33 . In this embodiment, the sensing module 41 is a blood oxygen sensor that can be used to measure the blood oxygen concentration of a human body, and the physiological signal is a blood oxygen concentration signal. In addition, the analysis module 42 is integrated with the electrical stimulation control module 33, but the implementation is not limited thereto.

The analysis module 42 includes a physiological signal analysis unit 421 and a physiological state determination unit 422 . The physiological signal analysis unit 421 receives and analyzes the blood oxygen concentration change represented by the physiological signal, converts the obtained blood oxygen concentration change into a heart rate variability (HRV), and further performs an analysis on the heart rate variability. The frequency domain conversion analysis will analyze the power spectral density of the corresponding high frequency region (0.15 ~ 0.40 Hz) and low frequency region (0.04 ~ 0.15 Hz).

The physiological state judging unit 422 analyzes and judges the relative relationship between the high-frequency region and the low-frequency region of the HRV according to a built-in autonomic balance condition, so as to determine whether the currently measured HRV represents the use of parasympathetic hypoactivity and/or sympathetic hyperactivity. The content of the autonomic nerve balance conditions includes, but is not limited to, when the parasympathetic nerves and sympathetic nerves are in balance, when the parasympathetic nerve activity is low, and when the sympathetic nerves are excited, the power increases in the low frequency region (0.04~0.15Hz) and the high frequency region. (0.15~0.4Hz) power drop, and the power ratio of low frequency area and high frequency area change and other parameters. The physiological state determination unit 422 generates the trigger signal and sends the trigger signal to the sound output device 5 when it is determined that the HRV of the physiological signal corresponds to the condition of low parasympathetic nerve activity and/or sympathetic nerve hyperactivity.

In addition, the physiological state determination unit 422 will stop generating the trigger signal when it is determined that the heart rate variability of the physiological signal is in line with the balance of parasympathetic nerves and sympathetic nerves, and the balance is maintained for more than a predetermined time, for example, for more than 5 minutes .

The sound output device 5 is connected to the physiological monitoring device 4, and has a built-in sound file. The sound file is music that can be used to help the user to soothe and relax, such as but not limited to natural music, musical instrument playing music and singing. etc., that is, various types of music that can be used to help stimulate the parasympathetic nervous system. The sound output device 5 can be triggered by the trigger signal to play and output the content of the sound file for the user to listen to.

Referring to FIGS. 1 and 7 , in this embodiment, the sound output device 5 is a separate device from the physiological monitoring device 4 , such as a wireless speaker, and the sound output device 5 is connected to the physiological monitoring device 5 through a signal of a currently known wireless communication technology. The monitoring device 4 can be triggered and activated by the trigger signal, and outputs the content of the sound file in amplifying manner for the user to listen to. However, during implementation, in other embodiments of the present invention, the sound output device 5 can also be a wireless earphone, or it can be changed to a type of earphone directly disposed on the shell body 311 (as shown in FIG. 7 ). When the casing mechanism 3 is worn on the ear portion 900 , it is used to be embedded in the ear portion 900 or abut against the ear bone, and output the sound file content for listening through air conduction or bone conduction. Since the sound output device 5 has many types, it will not be described in detail.

Referring to FIGS. 1 , 2 and 6 , when the auricle percutaneous nerve stimulator 200 of the present invention is worn by the user, the sound output device 5 can store a sound file that will relieve the user's mood after listening. The physiological monitoring device 4 will continuously measure and analyze the physiological signal of the user, and will trigger the electrical stimulation device 3 to activate the corresponding In the electrical stimulation mode, transcutaneous electrical stimulation is applied to the user's ear 900, and at the same time, the sound output device 5 is triggered to play and output the sound file, so as to help the user to soothe his emotions.

The physiological monitoring device 4 will stop generating the trigger signal when it is determined that the measured physiological signal represents the balance between the parasympathetic nerve and the sympathetic nerve, and the balance state is maintained for more than a predetermined time, so as to control the electrical stimulation device 3 and the sound The output device 5 stops operating.

In this embodiment, the physiological signal sensed by the sensing module 41 is the blood oxygen concentration signal, and the current sympathetic nerve// Parasympathetic state, and when parasympathetic activity is low and/or sympathetic is hyperactive, appropriate electrical stimulation and sound stimulation are given to help the user to ease emotions. However, because there are many types of physiological signals that can be used to analyze the balance of sympathetic nerves and parasympathetic nerves, for example, sympathetic nerves can also be judged by measuring and analyzing changes in Electrogastrography (EGG) or changes in Electroencephalography (EEG). In a state of balance with the parasympathetic nerves, and when parasympathetic nerve activity is low and/or sympathetic nerves are hyperactive, appropriate electrical stimulation and sound stimulation are given to the parasympathetic nerves through the ear 900 . Therefore, in other implementation aspects of the present invention, the sensing module 41 can also be designed to measure the physiological electrical signal type of the user, and adjust the content of the autonomic nervous balance condition accordingly, so that The physiological monitoring device 4 can also judge the balance state of the autonomic nervous system of the user according to the measured physiological electrical signals, and give appropriate electrical stimulation and sound stimulation feedback accordingly, so as to assist the user to adjust the balance state of the autonomic nervous system.

To sum up, the physiological monitoring device 4 can analyze and determine the balance state of the user's autonomic nervous system according to the changes of the measured physiological signals, and drive the electrical stimulation device 3 when judging that the parasympathetic nerve activity is low and/or the sympathetic nerve is hyperactive. The design of giving appropriate electrical stimulation and driving the sound output device 5 to give appropriate sound stimulation can be used to automatically analyze and judge the current physiological state of the user at any time, and give appropriate electrical stimulation and sound stimulation to help the user Maintain a state of autonomic balance at all times. Therefore, the auricle percutaneous nerve stimulator 200 of the present invention is indeed a rather innovative creation, and can indeed achieve the purpose of the present invention.

However, the above are only examples of the present invention, and should not limit the scope of implementation of the present invention. Any simple equivalent changes and modifications made according to the scope of the patent application of the present invention and the contents of the patent specification are still included in the scope of the present invention. within the scope of the invention patent.

200: Auricle percutaneous neurostimulator 3: Electrical stimulation device 31: Chassis mechanism 311: Shell body 312:Ear hanging rod 32: Electrode module 321: Electrode holder 322: Electrodes 323, 323': elastic parts 324: Clip 325: Operation Department 326: Clamping part 33: Electrical stimulation control module 4: Physiological monitoring device 41: Sensing module 42: Analysis Module 421: Physiological Signal Analysis Unit 422: Physiological state judgment unit 5: Sound output device 800: Remote Control 900: Ears

Other features and effects of the present invention will be clearly presented in the embodiments with reference to the drawings, wherein: FIG. 1 is a schematic perspective view schematically illustrating a situation when an embodiment of the auricle percutaneous nerve stimulator of the present invention is worn on the ear of a user; Figure 2 is a functional block diagram illustrating the architecture of this embodiment; 3 is a perspective view illustrating the structure of a housing mechanism and an electrical stimulation device of this embodiment; 4 is a perspective view illustrating the structure of the housing mechanism and the electrical stimulation device of this embodiment; 5 is an exploded perspective view illustrating the structure of the housing mechanism and the electrical stimulation device of this embodiment; 6 is a cross-sectional view illustrating the structure of the housing mechanism and the electrical stimulation device of this embodiment; and FIG. 7 is a perspective view illustrating another embodiment of a sound output device of this embodiment.

200: Auricle percutaneous neurostimulator

3: Electrical stimulation device

31: Chassis mechanism

311: Shell body

312:Ear hanging rod

32: Electrode module

321: Electrode holder

322: Electrodes

324: Clip

325: Operation Department

326: Clamping part

4: Physiological monitoring device

41: Sensing module

Claims (16)

An auricle percutaneous nerve stimulator, suitable for wearing on a user's ear, comprising: an electrical stimulation device, including a casing mechanism for hanging on the user's ear, at least one exposed on the user's ear An electrode module outside the casing mechanism and used for abutting against the ear, and an electrical stimulation control module disposed inside the casing mechanism and signally connected to the at least one electrode module, the at least one electrode module has An electrode seat that can be retractably passed through the casing mechanism, two electrodes arranged at intervals on the electrode seat and exposed outside the casing mechanism for abutting against the ears, and one electrode disposed in the casing mechanism There is an elastic member inside and always has an elastic force to push the electrode holder to the outside of the casing mechanism, the electrical stimulation control module is electrically connected to the electrodes, and can be triggered and activated by a trigger signal, and the pair of electrodes is passed through. An electrical stimulation signal is applied to the ear; and a physiological monitoring device, the signal is connected to the electrical stimulation control module, including a sensing module that is arranged on the user and can measure a physiological signal of the user and an analysis module capable of analyzing the physiological signal according to an autonomic balance condition, and the analysis module generates the trigger signal when the physiological signal is determined to be parasympathetic hypoactivity and/or sympathetic hyperactivity. The auricle percutaneous nerve stimulator according to claim 1, comprising a plurality of the electrode modules. The auricle percutaneous nerve stimulator according to claim 1, wherein the sensing module can sense blood oxygen to obtain the physiological signal, and the analysis module includes a A physiological signal analysis unit, and a physiological state determination unit, the physiological signal analysis unit can analyze the physiological signal to obtain the heart rate variability (HRV) of the user, and the physiological state determination unit can analyze and determine that the HRV is parasympathetic This triggering signal occurs when the nerve activity is low and/or the sympathetic nerve is high. The auricle percutaneous nerve stimulator according to claim 1, wherein the sensing module can be used to sense physiological electrical signals of a specific organ of the user to obtain the physiological signal, and the analysis module includes a physiological signal An analysis unit, and a physiological state determination unit, the physiological signal analysis unit can analyze the physiological signal to obtain the electrophysiological change state of the organ of the user, and the physiological state determination unit can analyze and determine that the electrophysiological change state is a parasympathetic nerve This triggering signal occurs when activity is low and/or sympathetic is hyperactive. The auricle percutaneous nerve stimulator according to claim 1, 2, 3 or 4, further comprising a sound output device with a built-in sound file, the sound output device signal is connected to the electrical stimulation control module, and will be The trigger signal triggers and starts to play the content of the sound file for the user to listen to. The auricle percutaneous nerve stimulator according to claim 1, 2, 3 or 4, wherein the electrical stimulation control module has a built-in continuous electrical stimulation mode and an intermittent electrical stimulation mode, and when switched to the continuous electrical stimulation mode In the stimulation mode, electrical stimulation signals are continuously output through the electrodes, and when switched to the intermittent electrical stimulation mode, electrical stimulation signals are output intermittently through the electrodes. The auricle percutaneous nerve stimulator according to claim 6, wherein the electrical stimulation control module further has a built-in random electrical stimulation mode, and when switching to the electrical stimulation control module In random electrical stimulation mode, electrical stimulation signals with random changes in the frequency range of 100-640 Hz will be output through these electrodes. An auricle percutaneous nerve stimulator, suitable for wearing on a user's ear, comprising: an electrical stimulation device, including a casing mechanism for hanging on the user's ear, at least one exposed on the user's ear An electrode module outside the casing mechanism and used for abutting against the ear, and an electrical stimulation control module disposed inside the casing mechanism and signally connected to the at least one electrode module, the at least one electrode module has A clip that can be operated and pivoted on the casing mechanism, two electrodes respectively arranged on the clip and the casing mechanism, and an elastic member installed between the clip and the casing mechanism , the elastic piece always has the elastic force to drive the corresponding electrode of the clip to swing toward the other electrode, so that the electrodes are matched and clamped against the ear, and the electrical stimulation control module is electrically connected to the electrodes , and can be triggered and activated by a trigger signal, and an electrical stimulation signal is applied to the ear through the electrodes; and a physiological monitoring device, the signal is connected to the electrical stimulation control module, including a A sensing module on the body that can measure a physiological signal of the user, and an analysis module that can analyze the physiological signal according to an autonomic nervous balance condition, the analysis module will analyze and determine that the physiological signal is a parasympathetic nerve This triggering signal occurs when activity is low and/or sympathetic is hyperactive. The auricle percutaneous nerve stimulator according to claim 8, comprising a plurality of the electrode modules. The auricle percutaneous nerve stimulator of claim 8, comprising two of the electrical Pole module, one of the electrode modules has an electrode seat which is retractably penetrated in the casing mechanism, and two electrodes are arranged at intervals in the electrode seat and are exposed outside the casing mechanism for abutting against the ear. Electrodes, and an elastic member arranged in the casing mechanism and constantly having the elastic force to push the electrode base to the outside of the casing mechanism, and the other electrode module has the clip, which are respectively arranged on the clip and the The electrodes of the casing mechanism, and the elastic piece installed between the clip and the casing mechanism. The auricle percutaneous nerve stimulator according to claim 8, wherein the sensing module can sense blood oxygen to obtain the physiological signal, and the analysis module includes a physiological signal analysis unit and a physiological state determination unit , the physiological signal analysis unit can analyze the physiological signal to obtain the heart rate variability (HRV) of the user, and the physiological state determination unit can analyze and determine that the HRV is generated when the parasympathetic nerve activity is low and/or the sympathetic nerve is hyperactive. trigger signal. The auricle percutaneous nerve stimulator according to claim 8, wherein the sensing module can be used to sense physiological electrical signals of a specific organ of the user to obtain the physiological signal, and the analysis module includes a physiological signal An analysis unit, and a physiological state determination unit, the physiological signal analysis unit can analyze the physiological signal to obtain the electrophysiological change state of the organ of the user, and the physiological state determination unit can analyze and determine that the electrophysiological change state is a parasympathetic nerve This triggering signal occurs when activity is low and/or sympathetic is hyperactive. The auricle percutaneous nerve stimulator according to any one of claims 8 to 12, further comprising a sound output device with a built-in sound file, the sound output The output device signal is connected to the electrical stimulation control module, and is triggered and activated by the trigger signal to play the content of the sound file for the user to listen to. The auricle percutaneous nerve stimulator according to any one of claims 8 to 12, wherein the electrical stimulation control module has a built-in continuous electrical stimulation mode and an intermittent electrical stimulation mode, and switches to the continuous electrical stimulation In the mode, the electrical stimulation signals are continuously output through the electrodes, and when switched to the intermittent electrical stimulation mode, the electrical stimulation signals are intermittently output through the electrodes. The auricle percutaneous nerve stimulator according to claim 14, wherein the electrical stimulation control module further has a built-in random electrical stimulation mode, and when switching to the random electrical stimulation mode, the electrodes are used Output electrical stimulation signals that vary randomly in the frequency range of 100~640Hz. An auricle percutaneous nerve stimulator, suitable for wearing on a user's ear, comprising: an electrical stimulation device, including a casing mechanism for hanging on the user's ear, at least one exposed on the user's ear An electrode module outside the casing mechanism and used for abutting against the ear, and an electrical stimulation control module disposed inside the casing mechanism and signally connected to the at least one electrode module, the electrical stimulation control module can It is triggered and activated by a trigger signal, and an electrical stimulation signal is applied to the ear through the at least one electrode module. The electrical stimulation control module has a built-in continuous electrical stimulation mode, an intermittent electrical stimulation mode, and a random electrical stimulation mode. The digital electrical stimulation mode, when switching to the continuous electrical stimulation mode, will continuously output electrical stimulation signals through the at least one electrode module, and when switching to the intermittent electrical stimulation mode, intermittently output electrical stimulation through the at least one electrode module When the signal is switched to the random electrical stimulation mode, it will pass through The at least one electrode module outputs an electrical stimulation signal that varies randomly in the frequency range of 100-640 Hz; and a physiological monitoring device, the signal is connected to the electrical stimulation control module, including a A sensing module for a physiological signal of the user, and an analysis module for analyzing the physiological signal according to an autonomic nervous balance condition, the analysis module will analyze and determine that the physiological signal is parasympathetic hypoactivity and/or sympathetic The trigger signal is generated when the nerve is excited.

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