CN106693179B - Waveform generating device and method of constant-current percutaneous ear vagus nerve stimulator - Google Patents
Waveform generating device and method of constant-current percutaneous ear vagus nerve stimulator Download PDFInfo
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- CN106693179B CN106693179B CN201710092865.9A CN201710092865A CN106693179B CN 106693179 B CN106693179 B CN 106693179B CN 201710092865 A CN201710092865 A CN 201710092865A CN 106693179 B CN106693179 B CN 106693179B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/025—Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/0404—Electrodes for external use
- A61N1/0408—Use-related aspects
- A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/08—Arrangements or circuits for monitoring, protecting, controlling or indicating
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36025—External stimulators, e.g. with patch electrodes for treating a mental or cerebral condition
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Abstract
The invention discloses a waveform generating device and method of a constant-current percutaneous ear vagus nerve stimulator, which comprises a constant-current control circuit and a waveform control circuit, wherein the constant-current control circuit controls output pulses to be in a constant-current mode, and the waveform control circuit controls the output pulses to be: the pulse generator comprises an initial spike T1, wherein the width of the initial spike is smaller than the minimum time threshold of a nerve sense cell, so that the pain sense of the nerve sense cell is not caused, meanwhile, the current intensity of 2-5mA generates at least 50V voltage drop at skin impedance (about 20-30 k ohm), the voltage drop can rapidly reduce the skin impedance, and the initial spike is a high-frequency signal with steep edges, and the signal can well penetrate through the skin and enter subcutaneous tissues. This initial spike achieves a rapid reduction in body impedance without producing pain and increases the efficiency of stimulating the subcutaneous nerve.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a waveform generating device and method of a constant-current percutaneous ear vagus nerve stimulator.
Background
Hypertension, diabetes, epilepsy, depression and the like are common diseases caused by neuroendocrine dysfunction, the traditional treatment method is mainly drug treatment, but the side effects of long-term taking of the drugs are many and are difficult to avoid. With the development of electrophysiology in recent years, electrical nerve stimulation therapy has proved to have definite therapeutic effects on over 20 kinds of neurological disorders, wherein stimulation of vagus nerve can treat hypertension, diabetes, epilepsy, depression, and other diseases, mainly because most internal organs are doubly innervated and regulated by vagus nerve and sympathetic nerve.
Clinical verification shows that the nerve electrical stimulation has good auxiliary treatment effect on epilepsy, diabetes, insomnia, depression and the like. There are mainly 2 methods of vagus nerve stimulation: one is implantable stimulation and the other is transcutaneous stimulation, which is expensive and requires surgery. The percutaneous stimulation does not need an operation, is convenient to operate and is cheaper.
The waveform of the existing percutaneous ear vagus nerve stimulation waveform generating device is mainly bipolar symmetrical square waves, bipolar asymmetrical square waves and unipolar square waves. Such stimulation waveforms suffer from the following disadvantages: 1. when the electric stimulation device is used, a user needs to adjust the intensity to a large value firstly to have the feeling of effective stimulation of current, the feeling is accompanied with a large pricking feeling, and then the user can adjust the electric stimulation device to a proper feeling according to the stimulation intensity. The strength is relatively troublesome to adjust; 2. without high frequency components, the effective stimulation of the subcutaneous vagus nerve is inefficient.
Disclosure of Invention
The invention aims to solve the technical problem of providing a waveform generating device and a method of a constant-current percutaneous ear vagus nerve stimulator aiming at the defects of the prior art.
The technical scheme of the invention is as follows:
the utility model provides a wave form generating device of constant current percutaneous ear vagus nerve stimulation appearance, includes constant current control circuit and wave form control circuit, and constant current control circuit control output pulse is the constant current mode, and wave form control circuit control output pulse is: comprises an initial spike T1, a high-level pulse T2 following the initial spike T1 and a low-level pulse T3 following the high-level pulse T2, wherein the initial spike T1 is a high-frequency signal with steep edges, the width of the initial spike T1 is less than the minimum time threshold (generally 40us) of the nerve sensory cell, preferably between 0.5us and 30us, preferably between 1us and 5us, and the constant current value is kept between 2 and 5mA during the duration of the initial spike T1;
the product of the amplitude of the low level pulse T3 and the duration of the low level pulse T3 is equal to the sum of the product of the amplitude of the start spike T1 and the duration of the start spike T1 and the product of the amplitude of the high level T2 and the duration of the high level T2; preferably, the amplitude of the low level pulse T3 is half of the amplitude of the high level pulse T2, and the duration of the low level pulse T3 is twice the time of the high level pulse T2 and the start spike T1; the preferred pulse width of the high-level pulse T2 is 80 us-300 us; the low level pulse T3 has a pulse width of 160us to 620 us.
In the waveform generating device, the pulse width of the high-level pulse T2 is 80 us-300 us; the low level pulse T3 has a pulse width of 160us to 620 us.
The waveform generating device has an initial spike pulse T1 constant current value of 2.5 mA.
The constant current value of the waveform generating device at the continuous stage of the high-level pulse T2 and the low-level pulse T3 is adjustable between 0.1 and 5 mA.
The stimulation frequency f of the constant current pulse of the waveform generating device is 20 Hz-30 Hz.
According to the waveform generating method of the waveform generating device, the waveform generating step is as follows: an initial spike T1 occurs, a high level pulse T2 occurs immediately after the initial spike T1, and a low level pulse T3 occurs immediately after the high level pulse T2, the initial spike T1 is a high frequency signal with steep edges, the width of the initial spike T1 is less than the minimum time threshold of the neurosensory cell, preferably between 0.5us and 30us, preferably between 1us and 5us, and the duration of the initial spike T1 is maintained at a constant current value of 2-5 mA.
The product of the amplitude of the low level pulse T3 and the duration of the low level pulse T3 is equal to the sum of the product of the amplitude of the start spike T1 and the duration of the start spike T1 and the product of the amplitude of the high level T2 and the duration of the high level T2; preferably, the amplitude of the low level pulse T3 is half of the amplitude of the high level pulse T2, and the duration of the low level pulse T3 is twice the time of the high level pulse T2 and the start spike T1; the preferred pulse width of the high-level pulse T2 is 80 us-300 us; the low level pulse T3 has a pulse width of 160us to 620 us.
In the waveform generation method, the pulse width of the high-level pulse T2 is 80 us-300 us; the low level pulse T3 has a pulse width of 160us to 620 us.
According to the waveform generation method, the constant current value of the initial spike pulse T1 is 2.5 mA.
According to the waveform generation method, the constant current values of the high-level pulse T2 and the low-level pulse T3 in the continuous stage are adjustable from 0.1 mA to 5 mA.
In the waveform generation method, the stimulation frequency f of the constant current pulse is 20Hz to 30 Hz.
The pulse width of the initial spike pulse is 0.5-30 us; the pulse width time is less than the minimum time threshold of the nerve sense cells by 40us, so that the pain sense of the nerve sense cells is not caused, meanwhile, the current intensity of 2.5mA generates at least 50V voltage drop on skin impedance (about 20-30 k ohms), the voltage drop can rapidly reduce the skin impedance (the skin impedance can rapidly drop after the voltage exceeds 50V), and meanwhile, the initial spike pulse is a high-frequency signal with comma edges, and the signal can well penetrate the skin and enter subcutaneous tissues. This initial spike achieves a rapid reduction in body impedance without producing pain and increases the efficiency of stimulating the subcutaneous nerve.
Drawings
FIG. 1 is a schematic diagram of the apparatus of the present invention;
FIG. 2 is a schematic diagram of waveforms according to the present invention;
Detailed Description
The present invention will be described in detail with reference to specific examples.
The waveform generating device of the constant-current percutaneous ear vagus nerve stimulation instrument comprises a constant-current control circuit and a waveform control circuit, wherein the constant-current control circuit controls output pulses to be in a constant-current mode, and the waveform control circuit controls the output pulses to be characterized in that: the pulse constant current control circuit comprises an initial spike T1, a high-level pulse T2 next to the initial spike T1 and a low-level pulse T3 next to the high-level pulse T2, wherein the initial spike T1 has a steep edge and a high-frequency signal, the width of the initial spike T1 is 0.5-30 us, the constant current value is kept at about 2.5mA in the initial spike duration period, and the pulse level in the initial spike duration period is different according to the initial impedance of a human body, and the preferred constant current value is 2.5 mA. The pulse width of the initial spike pulse is 0.5-30 us, more preferably 1-5 us, the pulse width time is less than the minimum time threshold of 40us of the nerve sensory cell, so that the pain sensation of the nerve sensory cell is not caused, simultaneously, the current intensity of 2.5mA generates at least 50V voltage drop on skin impedance (about 20-30 k ohm), the voltage drop can rapidly reduce the skin impedance (the skin impedance can rapidly drop after the voltage exceeds 50V), and simultaneously, the initial spike pulse T1 is a high-frequency signal with sharp edges, and the signal can well penetrate the skin and enter subcutaneous tissues. This initial spike achieves a rapid reduction in body impedance without producing pain and increases the efficiency of stimulating the subcutaneous nerve. In the existing percutaneous vagus nerve stimulation waveform generation device, the generated square wave has no initial spike pulse, and when the voltage on the skin impedance exceeds 50V, the continuous pulse width is 200us, so that the device can cause uncomfortable stabbing pain. The pain can be gradually eliminated after the human body is adapted by adjusting the pressure and the temperature back and forth for several times.
The pulse width of the next high-level pulse T2 is 80 us-300 us, and this part of high-level pulse is the effective stimulation part, after the initial spike T1 has reduced the skin impedance, at this time the stimulation intensity is gradually increased and stops increasing after reaching the sensory current threshold, and no pricking sensation is generated.
The pulse width of the last low-level pulse T3 is 160 us-620 us; the product of the amplitude of the low level pulse T3 and the duration of the low level pulse T3 is equal to the sum of the product of the amplitude of the start spike T1 and the duration of the start spike T1 and the product of the amplitude of the high level T2 and the duration of the high level T2; preferably, the amplitude of the low-level pulse T3 is about half of the amplitude of the high-level pulse T2; the duration of the low pulse T3 is about one time the duration of the high pulse T2 and the start spike T1. This low level pulse T3 is mainly used to eliminate the electrolytic action of the skin electrode.
The constant current values of the high-level pulse T2 and the low-level pulse T3 in the continuous stage are adjustable between 0.1 and 5 mA.
The stimulation frequency f of the constant current pulse is 20 Hz-30 Hz.
It will be understood that modifications and variations can be made by persons skilled in the art in light of the above teachings and all such modifications and variations are intended to be included within the scope of the invention as defined in the appended claims.
Claims (8)
1. The waveform generating device of the constant-current percutaneous ear vagus nerve stimulation instrument is characterized by comprising a constant-current control circuit and a waveform control circuit, wherein the constant-current control circuit controls output pulses to be in a constant-current mode, and the waveform control circuit controls the output pulses to be: the pulse comprises an initial spike T1, a high-level pulse T2 next to the initial spike T1 and a low-level pulse T3 next to the high-level pulse T2, wherein the initial spike T1 is a high-frequency signal with steep edges, the width of the initial spike T1 is less than the minimum time threshold of a nerve sensory cell and is between 0.5us and 30us, and the constant current value is kept at 2-5mA in the duration phase of the initial spike T1; the product of the amplitude of the low level pulse T3 and the duration of the low level pulse T3 is equal to the sum of the product of the amplitude of the start spike T1 and the duration of the start spike T1 and the product of the amplitude of the high level T2 and the duration of the high level T2; the amplitude of the low-level pulse T3 is half of that of the high-level pulse T2, and the duration of the low-level pulse T3 is twice that of the high-level pulse T2 and the initial spike pulse T1; the pulse width of the high-level pulse T2 is 80 us-300 us; the low level pulse T3 has a pulse width of 160us to 620 us.
2. The waveform generator of claim 1 wherein the initial spike T1 constant current value is 2.5 mA.
3. The waveform generator of claim 1, wherein the constant current values of the high-level pulse T2 and the low-level pulse T3 are adjustable within 0.1-5 mA.
4. The waveform generating apparatus according to claim 1, wherein the stimulation frequency f of the constant current pulse is 20Hz to 30 Hz.
5. The waveform generating method of the waveform generating apparatus according to claim 1, characterized in that the waveform generating step is: an initial spike T1 occurs, a high level pulse T2 occurs next to the initial spike T1, and a low level pulse T3 occurs next to the high level pulse T2, the initial spike T1 is a high frequency signal with steep edges, the width of the initial spike T1 is less than the minimum time threshold of the nerve sensory cell and is between 0.5us and 30us, and the constant current value is kept at 2-5mA during the duration of the initial spike T1; the product of the amplitude of the low level pulse T3 and the duration of the low level pulse T3 is equal to the sum of the product of the amplitude of the start spike T1 and the duration of the start spike T1 and the product of the amplitude of the high level T2 and the duration of the high level T2; the amplitude of the low-level pulse T3 is half of that of the high-level pulse T2, and the duration of the low-level pulse T3 is twice that of the high-level pulse T2 and the initial spike pulse T1; the pulse width of the high-level pulse T2 is 80 us-300 us; the low level pulse T3 has a pulse width of 160us to 620 us.
6. The method of claim 5, wherein the initial spike T1 constant current value is 2.5 mA.
7. The method for generating waveforms according to claim 5, wherein the constant current values of the high level pulse T2 and the low level pulse T3 are adjustable from 0.1 mA to 5 mA.
8. The method of claim 5, wherein the constant current pulse has a stimulation frequency f of 20 to 30 Hz.
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US8612008B2 (en) * | 2008-10-23 | 2013-12-17 | Electromedical Products International, Inc. | Microcurrent and cranial electrotherapy stimulator for control of anxiety, insomnia, depression and pain |
CN201410229Y (en) * | 2009-06-26 | 2010-02-24 | 复旦大学附属华山医院 | Neuromuscular rehabilitation instrument |
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