CN109718470A - The In-Ear noninvasive nervus auricularis vagi stimulation instrument of one kind and its pulse output method - Google Patents
The In-Ear noninvasive nervus auricularis vagi stimulation instrument of one kind and its pulse output method Download PDFInfo
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Abstract
The invention discloses a kind of In-Ear noninvasive nervus auricularis vagi stimulation instrument and its pulse output methods, including left and right two In-Ear electrodes, control devices；Wherein the two In-Ear electrodes in left and right all include 2 electrodes: concha auriculae area cranked electrode, external auditory canal electrode, so that stimulation field current energy all returns to control device along respective circuit；In-Ear electrode further includes the sound transmission aperture for having through electrode；Conductive retaining hole is provided on concha auriculae area cranked electrode and external auditory canal electrode, conductive retaining hole can protect conductive solvent not volatilized；Output waveform data corresponding to multimodality treatment built in control device exports different Wave datas according to different treatment modes.
Description
Technical field
The present invention relates to the fields for using current impulse energy stimulation nerve or tissue treatment related disease, more particularly to
Be a kind of In-Ear noninvasive nervus auricularis vagi stimulation instrument.Apparatus and method of the present invention can be used for stimulating the vagus nerve of patient
Auricular branch treats a variety of diseases, such as: headache, depression and anxiety, epilepsy, obesity, diabetes, Alzheimer's disease.
Background technique
Electro photoluminescence is used to treat existing more than 2000 years history of disease, but is actually used for clinical treatment, is 20th century 50
Age, the clinical application of first pacemaker.Modern electro-physiological research shows that: electrical stimulation can make neu straight
It connects or depolarizes indirectly, cause the electric discharge of action potential, or make neu hyperpolarization, action potential is prevented to discharge.This
The adjustable nerve fibre activity of kind nerve electric stimulation, and generate the physiological effect of some positive treatment diseases.
With the successful application of pacemaker, implantable neural electrical stimulation equipment is rapidly developed, and obtains and largely face
Bed application.Such as: implanted VNS stimulation is used to treat epilepsy, depression, obesity, Parsons；Lesions located in deep brain (DBS) is used for
The target treatment etc. of various cranial nerve function obstacles.Although implantable neural electrical stimulation equipment curative effect is reliable, need to perform the operation
Treatment, operation can damage part health tissues, it is possible to cause complication, and there are infection risk, and expensive, separately
It is exactly outside limited battery life, once dead battery capability, needs re-operation to carry out the replacement of equipment.These factors are very big
Limit implantable nerve stimulation promotion and application.
Non-built-in mode transcutaneous electrical stimulation (TENS) also has very long history, but until nineteen sixty-five Melzaclk and
Wall proposes " pain gate control theory ", just starts fast-developing.It was discovered by researchers that stimulating related mind by skin surface
Through, also can good control pain, stimulated without implanting.Non-built-in mode transcutaneous electrical stimulation (TENS) is existing
Very widely used, it is used not only for easing pain, such as: neuromuscular electric stimulation therapy (NMES) stimulates the muscle of innervation, with
Enhance the strength and endurance of injured muscle；Functional electrostimulation (FES) be utilized to activate nerve control muscle, for treat due to
Locomitivity caused by the reasons such as spinal cord, head injury lacks disease；Peripheral nerve electro photoluminescence is used to treat anxiety, insomnia, insane
The mental disorders such as epilepsy, depression.Non-built-in mode transcutaneous electrical stimulation (TENS) is typically all to require repeatedly to treat daily, often
Secondary treatment requires cleaning electrode and therapentic part, and smears conductive solvent, and operation is more troublesome, and being in addition exactly cannot be real
The now uninterrupted lasting stimulation in 24 hours as implantable nerve stimulation apparatus, therefore, it is also difficult to reach implantable nerve stimulation
Curative effect.Although being non-invasive therapy, it is easy the Sensory nerve fibre that skin is arrived in stimulation, generates tingling sensation.
Studies have shown that the differentiation of ear's concha auriculae is furnished with vagus nerve branch auricular branch " The Nerve Supply of the
Human Auricle-----ELMAR T.PEUKER*AND TIMM J.FILLER".Ear in vagal neck branch
Branch vagus nerve ending is abundant.The A class major diameter Medullated nerve fibre that auricular branch of vagus nerve also includes, although quantity is about neck
The 1/5 of vagus nerve branch, portion, illustrating from anatomical basis, which stimulates auricular branch of vagus nerve that can also reach, stimulates neck fan absent-minded
Through the same curative effect of branch.Auricular branch of vagus nerve is distributed in the skin of auricle and external auditory canal from superior ganglion outside backward
Skin, the 01- concha auriculae court of a feudal ruler as shown in Figure 1, skin at 02- cavity of concha and 03- external auditory canal.
Existing nervus auricularis vagi stimulation instrument (ear t-VNS) is generally all made of portable main machine+ear's electrode two parts, just
The formula host of taking is although easy to carry, but treats if necessary to 24 hours, and work or other non-time of having a rest carry not side
Just.And ear's electrode generally uses ear-clip electrodes or earplug electrode.Ear-clip electrodes wearing easily causes discomfort, earplug
Electrode is even more to be easy to influence hearing.Electrode material generally uses metal electrode+Signa Gel or electric silica gel+conduction liquid side
Formula.Metal electrode+Signa Gel covers every time using requiring cleaning electrode if Signa Gel is not smeared, and leads
Cause metal electrode and direct skin contact, it is easy to cause electric injury.Electric silica gel+conduction liquid mode is easy because of conduction liquid
Volatilization, and impedance increase between electric silica gel and skin is made to cause tingling sensation.CN105056394A discloses a kind of host and electricity
Pole integral type nervus auricularis vagi stimulation instrument wears portability and comfort although improving, does not solve above-mentioned continuous 24
The problems such as hour stimulation and conduction liquid volatilization and tingling sensation.
Summary of the invention
The purpose of the present invention is to provide a kind of In-Ear noninvasive percutaneous nervus auricularis vagi stimulating apparatus and its pulse outputs
Method can be passed to neuromodulation signal ear's vagus nerve tissue by the device, to reach the mesh for the treatment of disease
's.
The invention discloses a kind of convenient for wearing in 24 hours, In-Ear noninvasive percutaneous nervus auricularis vagi stimulating apparatus, use
In the treatment of the mental diseases such as treatment epilepsy, depression, Parsons and self-closing disease, it can also be used to which the diseases such as diabetes and obesity are controlled
Treatment or clinical research.
To achieve the above object, the technical solution adopted by the present invention are as follows:
A kind of In-Ear noninvasive nervus auricularis vagi stimulation instrument, including left and right two In-Ear electrodes, control devices；It is wherein left
Right two In-Ear electrodes all include 2 electrodes: concha auriculae area cranked electrode, external auditory canal electrode, so that stimulation field current energy is all
Control device is returned along respective circuit；In-Ear electrode further includes the sound transmission aperture for having through electrode；Concha auriculae area cranked electrode and outer
Conductive retaining hole is provided on ear canal electrode, conductive retaining hole can protect conductive solvent not volatilized；It is a variety of built in control device
Output waveform data corresponding to treatment mode exports different Wave datas according to different treatment modes.
The In-Ear noninvasive nervus auricularis vagi stimulation instrument, the control device are used to control pulse output parameter and production
Output pulse signal is conveyed to pulse output driving circuit by raw output waveform, and the waveform includes high frequency burst mode and low
Frequency spike mode, high frequency burst mode include continuous 3~20 high-frequency impulses T1, each high-frequency impulse duration T 1
For 5us~200us, later immediately be intermittent time T4 and balancing charge negative pulse time T6, the T6 duration guarantees and T1
Charge balance relationship is kept, is circuited sequentially later followed by intermittent time T5, T1, T4, T6, T5, a cycle duration
T2 is 200ms~1000ms；Low frequency spike mode includes a spike T3, and the duration is 1us~100us, and then
To stimulate high level time, be 100us~1000us, be followed by intermittent time T4 ', the duration be 20us~
1000us, is followed by negative electrical charge equalizing pulse time T6 ', T6 ' duration and T3+T7 keeps charge balance relationship, it
Afterwards followed by intermittent time T5 ', the T5 ' duration is related to frequency of stimulation, circuits sequentially, a cycle duration T 2 '
About 200ms~1000ms.
The In-Ear noninvasive nervus auricularis vagi stimulation instrument, the microprocessor be also used to monitor concha auriculae area cranked electrode,
The contact condition of external auditory canal electrode and ear skin.
The In-Ear noninvasive nervus auricularis vagi stimulation instrument, concha auriculae area cranked electrode and external auditory canal electrode stimulating point are
In the concha auriculae court of a feudal ruler and external auditory canal or in cavity of concha and external auditory canal, the direction of an electric field of concha auriculae area cranked electrode and the formation of external auditory canal electrode
Along auricular branch of vagus nerve axial direction.
The In-Ear noninvasive nervus auricularis vagi stimulation instrument, concha auriculae area cranked electrode and external auditory canal electrode are using medical
Conductive carbon silica gel, or using the isolation material of high-dielectric constant, pass through the electric field signal stimulation target mind of the high fdrequency component of electrode
Through.
The In-Ear noninvasive nervus auricularis vagi stimulation instrument, conduction keeps 0.5~2mm of bore dia, so that skin and electricity
Pole is in close contact, and forms stable contact interface, guarantees the efficiency of stimulation, and is avoided after treating conductive solvent volatilization for a long time
Caused skin burns sense and tingling sensation.
The In-Ear noninvasive nervus auricularis vagi stimulation instrument, control device and In-Ear electrode are connected by flexible cable
It connects, or In-Ear electrode is directly integrated into control device.
The In-Ear noninvasive nervus auricularis vagi stimulation instrument, control device include that battery, microprocessor and pulse are defeated
Out driving circuit, boost control circuit, constant-current control circuit, battery charging and battery cell monitoring, output open circuit short-circuit detecting with
And external communication circuit；Battery is powered to microprocessor and pulse output driving circuit；Microprocessor connects battery and pulse is defeated
Driving circuit out, microprocessor use low-power microprocessor, are built-in with multimodality treatment；The pulse output driving electricity
Road is double-polarity control driving circuit, connects battery and microprocessor.
According to the pulse output method of the nervus auricularis vagi stimulation instrument, it is first carried out:
Step 802: which kind of pulse the judgement output pulse of the treatment mode according to selected by user should be, and break out arteries and veins if it is high frequency
Punching, thens follow the steps 803, if it is low frequency spike, thens follow the steps 811；
Step 803: initialization timer parameter is high frequency blast parameter, and opens timer interruption, next
It executes:
Step 804: next one high-frequency impulse of output executes:
Step 805: judging whether high-frequency impulse the number of output has arrived at 5, if reaching 5 thens follow the steps 806；
Otherwise it continues to execute step 804 and exports next high-frequency impulse；
Step 806: interval 100us guarantees that nerve impulse has passed, avoids next negative neutralization impulse disturbances
Next the transmitting of nerve impulse executes:
Step 807: output one negative neutralization pulse is used to balancing charge, next executes:
Step 808: the intermittent time being calculated according to the frequency of setting, next wakeup time intermittent time thus is set, connect
Get off to execute:
Step 809: entering low-power consumption mode, save electric energy, wait the intermittent time to then waking up microprocessor；
Step 810: a high frequency blast end cycle；
Step 811: initialization timer is low frequency spike parameter, and opens timer interruption, is next executed:
Step 812: next one spike of output executes:
Step 813: wait the spike time to arrive, the spike time is to then executing:
Step 814: exporting high level pulse immediately；Next it executes:
Step 815: wait high level time to arrive, high level time is to then executing:
Step 806: interval 100us guarantees that nerve impulse has passed, avoids next negative neutralization impulse disturbances
Next the transmitting of nerve impulse executes step 807 and exports a negative neutralization pulse, is used to balancing charge；Next step is executed
Rapid 808, the intermittent time is calculated according to the frequency of setting, next wakeup time intermittent time thus is set, step is next executed
Rapid 809, into low-power consumption mode, electric energy is saved, waits the intermittent time to microprocessor is waken up, arrives this step 810, a low frequency
Spike end cycle.
The pulse output method of the nervus auricularis vagi stimulation instrument, the step 802: the treatment mode according to selected by user
Which kind of pulse judgement output pulse should be, specifically includes the following steps:
Step 903: reading treatment mode if it is epilepsy therapy mode and then follow the steps 905；In step 905, make
Stimulation 5 minutes/20 minutes treatment modes in interval are carried out with low frequency spike, repeat step 905 until executing step
912 terminate shutdown, complete an epilepsy therapy；If it is blahs aypnia treatment mode, step 907 is executed, in step 907,
Executing high frequency blast stimulates 5 minutes/interval, 15 minutes treatment modes, executes step 907 repeatedly until executing step 912
Terminate shutdown, completes primary depressed sleep pattern treatment；If it is weight reducing treatments mode, 909 are thened follow the steps, in step 909
In, it is alternately stimulated using low frequency spike/high frequency blast, alternately stimulation is spaced 30 minutes after five minutes, repeats step
909 terminate shutdown until executing step 912, complete primary weight-reducing mode treatment；If it is customized treatment mode, led to by user
It crosses key or PORT COM setting treatment waveform selection, frequency and the parameters such as intensity and treatment time carries out customized control
It treats, terminates shutdown until executing step 912, complete primary customized treatment.
The present invention is designed by reasonable form and electrode structural designs, and solve ear t-VNS has to subcutaneous nerve stimulation is goed deep into
The low problem of effect property enables electrode to last for hours even days of holding wet by designing built-in earplug electrode structure
Moisten to solve the problems, such as to be easy because conductive molten volatilization causes tingling sensation.By way of opening aperture to earplug electrode patient is made
Hearing is not influenced when with equipment, external sound cannot be heard by solving the problems, such as ear t-VNS when because treating.Simultaneously because this equipment is excellent
Change circuit structure design, optimizes stimulation programs, patient can be treated with very easily 24 hours wearable devices, to reach and plant
Enter the same treatment means of Formula V NS stimulation.
Detailed description of the invention
Fig. 1 is the schematic diagram of electrode stimulating point of the present invention position；
Fig. 2 is the structural schematic diagram of an embodiment of the invention；
Fig. 3 is the electrode structural chart of an embodiment of the invention；
Fig. 4 is the controller structure diagram of an embodiment of the invention；
Fig. 5 is system structure diagram of the invention；
Fig. 6 is the stimulus waveform schematic diagram of an embodiment of the invention；
Fig. 7 is the circuit structure block diagram of an embodiment of the invention；
Fig. 8 is the output waveform control flow chart of an embodiment of the invention；
Fig. 9 is the treatment mode control flow chart of an embodiment of the invention；
Specific embodiment
Below in conjunction with specific embodiment, the present invention is described in detail.
As shown in Fig. 2, this embodiment includes two In-Ear electrodes 107, control devices 108 of left and right.Wherein left and right two
A In-Ear electrode all includes 2 electrodes: concha auriculae area cranked electrode 6, external auditory canal electrode 7, so that stimulation field current energy all edges
Respective circuit returns to control device 108.
As shown in figure 3, In-Ear electrode 107 includes concha auriculae area cranked electrode 6 and external auditory canal electrode 7, electric field or electric current energy
Amount after concha auriculae area skin and subcutaneous nervus auricularis vagi branch make nervous excitation, passes through external ear from concha auriculae area cranked electrode 6
Road electrode 7 returns to control device 108.
In-Ear electrode 107 further includes the sound transmission aperture 9 for having through electrode, can conduct sound to ear, guarantee equipment just
Often when treatment, patient's hearing is not influenced；
It is provided with conductive solvent on concha auriculae area cranked electrode 6 and external auditory canal electrode 7 and keeps structure -- conductive retaining hole 8, it is conductive
Preferred 0.5~the 2mm of diameter of retaining hole 8, conductive retaining hole 8 can protect conductive solvent not volatilized, so that skin and electrode seal
Contact, forms stable contact interface, guarantees the efficiency of stimulation, and avoids caused by being treated after conductive solvent volatilization for a long time
Skin burns sense and tingling sensation.
The shell mechanism of control device 108 is as shown in figure 4, include key (10,11,12), indicator light 13, wherein key 10
For power switch, key 11 and key 12 are respectively the increase of strength control and reduce key, and indicator light 13 indicates current device
Working condition.
Control device 108 can be connected with In-Ear electrode 107 by flexible cable, can also be by directly In-Ear
Electrode is integrated to be welded to control device 108, this depends on the size of structure design and circuit board and battery of the invention.Control
Device 108 includes battery 102, microprocessor 101 and pulse output driving circuit 103, boost control circuit, current constant control electricity
Road, battery charging and battery cell monitoring, output open circuit short-circuit detecting and external communication circuit.Battery 102 gives microprocessor 101
It powers with pulse output driving circuit 103, disposable battery or rechargeable battery, preferably chargeable electricity can be used in battery
Pond；Microprocessor 101 is core component, connects battery 102 and pulse output driving circuit 103, and microprocessor 101 uses low function
Microprocessor is consumed, multimodality treatment is built-in with；The pulse output driving circuit 103 is double-polarity control driving circuit,
Battery 102 and microprocessor 101 are connected, can be realized by H-bridge circuit or high voltage analog switch, in this embodiment,
Integrated level can be improved in preferably high voltage analog switch, reduces circuit volume, and simplified control program.
The control device 108 is used to control pulse output parameter and generates output waveform, and output pulse signal is conveyed
To pulse output driving circuit 103, the waveform includes high frequency burst mode and low frequency spike mode, as shown in fig. 6, high
Frequency burst mode (a figure) is by continuous high frequency pulse (3~20 pulses), and preferably 5, each high-frequency impulse duration T 1
About 5us~200us, preferably 100us, later immediately be intermittent time T4 and balancing charge negative pulse time T6, T6
Duration guarantees and T1 keeps charge balance relationship, later followed by intermittent time T5, T5 duration and frequency of stimulation
Correlation, in a stimulation period, the remaining time is all the T5 duration, and T1, T4, T6, T5 are circuited sequentially, and a cycle is lasting
Time T2 is about 200ms~1000ms, i.e., frequency is about 1Hz~50Hz.
Low frequency spike mode (b figure) is about 1us~100us by a spike T3 duration, preferably 10us, tightly
It then is stimulation high level time, about 100us~1000us；Preferably 250us is followed by intermittent time T4 ', continues
Time is about 20us~1000us, is followed by negative electrical charge equalizing pulse time T6 ', T6 ' duration and T3+T7 keeps electricity
Lotus equilibrium relation, later followed by intermittent time T5 ', the T5 ' duration is related to frequency of stimulation, in a stimulation period,
The remaining time is all the T5 ' duration, is circuited sequentially, and a cycle duration T 2 ' is about 200ms~1000ms, i.e. frequency
Rate is about 1Hz~50Hz.Waveform pattern and parameter are adjusted according to the treatment condition of patient, to reach optimum efficiency.
The microprocessor 101 is also used to monitor the contact shape of concha auriculae area cranked electrode 6, external auditory canal electrode 7 with ear skin
State.
The control device 8 also utilizes boost pulse off time gap, whole equipment power consumption is preferably minimized, extension is set
It is standby to use the time, have the function of low power operation.
The In-Ear electrode 107 is used to contact with concha auriculae area, ear or skin of external auditory canal, forms electrode/skin energy
Electric field energy stimulation is transmitted to the nervus auricularis vagi that underlying nerve is especially axially distributed along external auditory canal by transition interface.Electrode
Shape meet human body ear ergonomic designs.
Each In-Ear electrode 107 includes at least 2 electrodes, concha auriculae area cranked electrode 6 as shown in Figure 3 and external auditory canal electrode
7.03 in concha auriculae area cranked electrode 6 and the external auditory canal electrode 7 preferred stimulation point position concha auriculae as shown in Figure 1 court of a feudal ruler 01 and external auditory canal,
Or 03 in cavity of concha 02 and external auditory canal.In order to which the direction of an electric field that concha auriculae area cranked electrode 6 and external auditory canal electrode 7 are formed is walked along fan
Neural auricular branch axial direction.Concha auriculae area cranked electrode 6 and external auditory canal electrode 7 preferably use medical conductive carbon silica gel, concha auriculae
On the area's cranked electrode 6 and external auditory canal electrode 7 and surface of skin contact is covered with aperture, and use when can use conduction liquid, physiology
As contact solvent, aperture is used to be kept in contact the wettability in face for salt water or tap water, guarantees the energy conversion of contact surface, makes
Electric field energy can most efficiency arrival target nerve-branch, vagus nerve ear.Concha auriculae area cranked electrode 6 and external auditory canal
The isolation material of high-dielectric constant also can be used in electrode 7, passes through the electric field signal stimulation target nerve of the high fdrequency component of electrode.
The circuit structure block diagram of control device 8 such as Fig. 7.Battery detecting and charge protection use USB Charge Management IC chip,
Low-power microprocessor 101 can inquire battery status information by this IC chip.Keyboard input module 203 can be using touch
Key or miniature microswitch key are realized.Keying input information is also connected to low-power microprocessor 101, realizes treatment ginseng
Several some settings.Power switch 204 is arranged using key switch, this switch key is connected to low-power microprocessor 101, also
The long short-press multifunctional multiplexing of software realization can be passed through.Bluetooth or NFC communicating circuit 205 use low-power consumption in this embodiment
Some waveform parameters and corresponding treatment mode is arranged for connecting cell phone application in bluetooth communication.Boost control circuit 206 connects
Battery and low-power microprocessor 101 and output waveform driving circuit 207 are connect, boost control circuit passes through low-power consumption micro process
The pwm control signal that device 101 generates obtains wanting the voltage of acquisition, and preferred voltage is about 80V.Output waveform driving circuit 207
It is realized using high pressure simulation two-way analog switch, low-power microprocessor 101 generates control signal, controls the conducting of analog switch
With close to control output waveform, and driven by constant-current source circuit, electric current or electric field energy be output to electrode with
Electrode interface 208.In this embodiment, low-power microprocessor 101 is realized using 8 low-power scm STM8L151.
Pulse output driving circuit 103 exports stimulus waveform shown in fig. 6 under the control of low-power microprocessor 101,
Fig. 8 show the flow chart of high frequency blast and low frequency spike output control method.Pulse output is controlled from step 801
Start, the judgement output pulse of step 802 treatment mode according to selected by user is first carried out should be for which kind of pulse, quick-fried if it is high frequency
Pulse is sent out, 803 is thened follow the steps, if it is low frequency spike, thens follow the steps 811.In step 803, initialization timing
Device parameter is high frequency blast parameter, and opens timer interruption, next executes step 804 and exports a high frequency arteries and veins
Next punching executes step 805 and carries out judging whether high-frequency impulse the number of output has arrived at 5, executes if reaching 5
Step 806, it otherwise continues to execute step 804 and exports next high-frequency impulse.In step 806, interval 100us guarantees nerve punching
It is dynamic to have passed, the next negative transmitting for neutralizing impulse disturbances nerve impulse is avoided, step 807 output is next executed
One negative neutralization pulse, is used to balancing charge.Next step 808 is executed, the intermittent time is calculated according to the frequency of setting, is connect down
Wakeup time is arranged, intermittent time, following execution step 809 save electric energy into low-power consumption mode, wait interval thus
Time to microprocessor is then waken up, arrives high frequency blast end cycle of step 810.In step 811, initialization timing
Device is low frequency spike parameter, and opens timer interruption, next executes step 812, exports a spike, connect
Getting off to execute step 813 waits the spike time to arrive, and continues waiting for less than if in step 813 if the spike time, no
Then, the spike time to thening follow the steps 814, exports high level pulse immediately.Next it executes step 815 and waits high electricity
It is arrived between usually, if high level time does not arrive, continues to wait in step 815, otherwise wait for high level time to then executing step
Rapid 806, in step 806, interval 100us guarantees that nerve impulse has passed, and avoids next negative neutralization pulse dry
The transmitting of nerve impulse is disturbed, step 807 is next executed and exports a negative neutralization pulse, be used to balancing charge.Next it executes
Step 808, the intermittent time is calculated according to the frequency of setting, next wakeup time intermittent time thus is set, next execute
Step 809, into low-power consumption mode, electric energy is saved, waits the intermittent time to microprocessor is waken up, arrives this step 810, one low
Frequency spike end cycle.
Which kind of pulse the judgement output pulse of rapid 802 treatment modes according to selected by user should be, it is described in detail below how root
Output pulse is selected according to treatment mode, Fig. 9 show the treatment mode control flow of In-Ear nervus auricularis vagi stimulation instrument 100.
Treatment mode is controlled since step 901, and step 902, initialization output channel, stimulus modality and parameter and phase is first carried out
Close hardware port.Next step 903 is executed, treatment mode is read if it is epilepsy therapy mode and thens follow the steps 905.?
In step 905, stimulation 5 minutes/20 minutes treatment modes in interval are carried out using low frequency spike, repeat step 905
Terminate shutdown until executing step 912, completes an epilepsy therapy.If it is blahs aypnia treatment mode, step 907 is executed,
In step 907, executing high frequency blast stimulates 5 minutes/interval, 15 minutes treatment modes, and it is straight to execute step 907 repeatedly
Terminate shutdown to step 912 is executed, completes primary depressed sleep pattern treatment.If it is weight reducing treatments mode, then follow the steps
909, in step 909, alternately stimulated using low frequency spike/high frequency blast, alternately stimulation is spaced 30 points after five minutes
Clock, repeating step 909 until executing step 912 terminates shutdown, completes primary weight-reducing mode treatment.If it is customized treatment mould
Formula, by user by key or PORT COM setting treatment waveform selection, frequency and the parameters such as intensity and treatment time into
The customized treatment of row terminates shutdown until executing step 912, completes primary customized treatment.
By the description of the drawings and specific embodiments, from output waveform, circuit theory and Row control it is several in terms of it is detailed
Describe clear technical solution of the present invention in detail.Aforesaid way is the preferred embodiment of the present invention, in the art common
For technical staff, on the basis of one kind disclosed by the invention In-Ear noninvasive nervus auricularis vagi stimulation instrument, it is easy to expect
It is modified or replaced equivalently, is applied to various transcutaneous electrostimulation medical instrument systems, is not limited solely to tool of the present invention
System structure described in body embodiment, therefore previously described mode is only preferred, and not restrictive meaning
Justice.
Claims (10)
1. a kind of In-Ear noninvasive nervus auricularis vagi stimulation instrument, which is characterized in that including the two In-Ear electrodes in left and right, control dress
It sets；Wherein the two In-Ear electrodes in left and right all include 2 electrodes: concha auriculae area cranked electrode, external auditory canal electrode, so that stimulation field is electric
Stream energy all returns to control device along respective circuit；The diameter of external auditory canal electrode is suitably inserted into user's external auditory canal；It is In-Ear
Electrode further includes the sound transmission aperture for having through electrode；Equally distributed conductive guarantor is provided on concha auriculae area cranked electrode and external auditory canal electrode
Hole is held, conductive retaining hole can protect conductive solvent not volatilized；Output wave corresponding to multimodality treatment built in control device
Graphic data exports different Wave datas according to different treatment modes.
2. In-Ear noninvasive nervus auricularis vagi stimulation instrument according to claim 1, which is characterized in that the control device
108 are used to control pulse output parameter and generate output waveform, and output pulse signal is conveyed to pulse output driving circuit
103, the waveform includes high frequency burst mode and low frequency spike mode, and high frequency burst mode includes continuous 3~20
High-frequency impulse T1, each high-frequency impulse duration T 1 be 5us~200us, later immediately be intermittent time T4 and balance electricity
Bear burst length T6, the T6 duration guarantees and T1 keeps charge balance relationship, later followed by intermittent time T5, T1,
T4, T6, T5 are circuited sequentially, and a cycle duration T 2 is 200ms~1000ms；Low frequency spike mode includes a spike arteries and veins
T3 is rushed, it, and then to stimulate high level time, is 100us~1000us, between being followed by that the duration, which is 1us~100us,
Have a rest time T4 ', and the duration is 20us~1000us, is followed by negative electrical charge equalizing pulse time T6 ', T6 ' duration
Charge balance relationship is kept with T3+T7, later followed by intermittent time T5 ', the T5 ' duration is related to frequency of stimulation, according to
Secondary circulation, a cycle duration T 2 ' are 200ms~1000ms.
3. In-Ear noninvasive nervus auricularis vagi stimulation instrument according to claim 1, which is characterized in that the microprocessor is also
For monitoring the contact condition of concha auriculae area cranked electrode, external auditory canal electrode and ear skin.
4. In-Ear noninvasive nervus auricularis vagi stimulation instrument according to claim 1, which is characterized in that the curved electricity in concha auriculae area
Pole and external auditory canal electrode stimulating point be in the concha auriculae court of a feudal ruler and external auditory canal or in cavity of concha and external auditory canal, concha auriculae area cranked electrode and outer
The direction of an electric field that ear canal electrode is formed is along auricular branch of vagus nerve axial direction.
5. In-Ear noninvasive nervus auricularis vagi stimulation instrument according to claim 1, which is characterized in that the curved electricity in concha auriculae area
Pole and external auditory canal electrode use medical conductive carbon silica gel, or using the isolation material of high-dielectric constant, pass through the high frequency division of electrode
The electric field signal stimulation target nerve of amount.
6. In-Ear noninvasive nervus auricularis vagi stimulation instrument according to claim 1, which is characterized in that conduction keeps bore dia
0.5~2mm, so that skin and electrode seal contact, form stable contact interface, guarantee the efficiency of stimulation, and avoid growing
Caused skin burns sense and tingling sensation after the volatilization of chronotherapy conductive solvent.
7. In-Ear noninvasive nervus auricularis vagi stimulation instrument according to claim 1, which is characterized in that control device and pleasant
Formula electrode is connected by flexible cable, or In-Ear electrode is directly integrated into control device.
8. In-Ear noninvasive nervus auricularis vagi stimulation instrument according to claim 1, which is characterized in that control device includes electricity
Pond, microprocessor and pulse output driving circuit, boost control circuit, constant-current control circuit, battery charging and battery prison
Control, output open circuit short-circuit detecting and external communication circuit；Battery is powered to microprocessor and pulse output driving circuit；Micro- place
Device connection battery and pulse output driving circuit are managed, microprocessor uses low-power microprocessor, and built-in there are many treat mould
Formula；The pulse output driving circuit is double-polarity control driving circuit, connects battery and microprocessor.
9. the pulse output method of -8 any nervus auricularis vagi stimulation instruments according to claim 1, which is characterized in that first
It executes:
Step 802: which kind of pulse the judgement output pulse of the treatment mode according to selected by user should be, if it is high frequency blast,
803 are thened follow the steps, if it is low frequency spike, thens follow the steps 811；
Step 803: initialization timer parameter is high frequency blast parameter, and opens timer interruption, is next executed:
Step 804: next one high-frequency impulse of output executes:
Step 805: judging whether high-frequency impulse the number of output has arrived at 5, if reaching 5 thens follow the steps 806；Otherwise
It continues to execute step 804 and exports next high-frequency impulse；
Step 806: interval 100us guarantees that nerve impulse has passed, and avoids next negative neutralization impulse disturbances nerve
Next the transmitting of impulsion executes:
Step 807: output one negative neutralization pulse is used to balancing charge, next executes:
Step 808: the intermittent time being calculated according to the frequency of setting, next wakeup time intermittent time thus is set, next
It executes:
Step 809: entering low-power consumption mode, save electric energy, wait the intermittent time to then waking up microprocessor；
Step 810: a high frequency blast end cycle；
Step 811: initialization timer is low frequency spike parameter, and opens timer interruption, is next executed:
Step 812: next one spike of output executes:
Step 813: wait the spike time to arrive, the spike time is to then executing:
Step 814: exporting high level pulse immediately；Next it executes:
Step 815: wait high level time to arrive, high level time is to then executing:
Step 806: interval 100us guarantees that nerve impulse has passed, and avoids next negative neutralization impulse disturbances nerve
Next the transmitting of impulsion executes step 807 and exports a negative neutralization pulse, is used to balancing charge；Next step is executed
808, the intermittent time is calculated according to the frequency of setting, next wakeup time intermittent time thus is set, step is next executed
809, into low-power consumption mode, electric energy is saved, waits the intermittent time to microprocessor is waken up, arrives this step 810, a low frequency point
The peak pulse period terminates.
10. the pulse output method of nervus auricularis vagi stimulation instrument according to claim 9, which is characterized in that the step
802: which kind of pulse the judgement output pulse of the treatment mode according to selected by user should be, specifically includes the following steps:
Step 903: reading treatment mode if it is epilepsy therapy mode and then follow the steps 905；In step 905, use is low
Frequency spike carries out stimulation 5 minutes/20 minutes treatment modes in interval, repeats step 905 until executing step 912 knot
Shu Guanji completes an epilepsy therapy；If it is blahs aypnia treatment mode, executes step 907 and execute height in step 907
Frequency blast stimulates 5 minutes/interval, 15 minutes treatment modes, and execute step 907 repeatedly terminates to close until executing step 912
Machine completes primary depressed sleep pattern treatment；If it is weight reducing treatments mode, 909 are thened follow the steps, in step 909, is used
Low frequency spike/high frequency blast alternately stimulates, and alternately stimulation is spaced 30 minutes after five minutes, repeats step 909 until holding
Row step 912 terminates shutdown, completes primary weight-reducing mode treatment；If it is customized treatment mode, by user by key or
Person's PORT COM setting treatment waveform selection, frequency and the parameters such as intensity and treatment time carry out customized treatment, until holding
Row step 912 terminates shutdown, completes primary customized treatment.
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