CN101069769A - Needle-free pain-relieving instrument and its setting method - Google Patents

Needle-free pain-relieving instrument and its setting method Download PDF

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CN101069769A
CN101069769A CN 200710021061 CN200710021061A CN101069769A CN 101069769 A CN101069769 A CN 101069769A CN 200710021061 CN200710021061 CN 200710021061 CN 200710021061 A CN200710021061 A CN 200710021061A CN 101069769 A CN101069769 A CN 101069769A
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pulse
frequency
output
needle
pain
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韩济生
刘亦鸣
郝学元
刘希蒙
戴�峰
万绍瑾
陆显革
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NANJING JISHENG MEDICAL SCIENCE-TECHNOLOGY Co Ltd
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Abstract

The present invention relates to a needleless pain-alleviating apparatus. It is characterized by that said needleless pain-alleviating apparalus can output dilatational wave with 2H2 low-frequency and 100 plus or minus 10H2 high-frequency and uses said dilalational wave as electric pulse stimulation signal so as to attain the goal of alleviating pain. Said needleless pain-alleviating apparatus includes the following several portions: microcontroller, low-frequency signal generator, high-frequency signal generator, low-pass filter and mos switch. Said invention also provides the working principle of said meedleless pain-alleviating apparatus and its concrete operation method.

Description

A kind of needle-free pain-relieving instrument and method to set up thereof
Technical field
The present invention relates to the to ease pain method to set up and the instrument of equipment also comprise the method and apparatus that the human body vegetative nerve stimulates.
Background technology
Acupuncture is used for the treatment of various acute and chronic disease, in the existing history in several thousand of China.Particularly the analgesic effect of acupuncture receive magical effect sometimes, but its action principle is rarely known by the people.Chinese medicine thinks that the function of human body is controlled by channel system and the QI and blood that runs on wherein, and acupuncture reaches the purpose for the treatment of sick health care by restoring menstrual flow and invigorating blood circulation.China medical investigator also attempts to explain the acapuncture action principle with modern medicine means and theory when exploring meridians essence with all strength.The fifties later stage in this century, the clinical trial that has the human acupoint to produce analgesic effect, and design and use the pain that needle-punching method comes the prevention of surgical operation, be referred to as " acupuncture anesthesia ", cause very big interest at home and abroad.Find that after deliberation the generation of analgesic activity needs 20-30 minute induction period, (about 16 minutes) are then followed certain half-life in its disappearance.They provide hypothesis from this rule, think that acupoint can cause that producing certain chemical substance in the brain brings into play analgesic activity.This hypothesis has obtained proof in the experiment of rabbit and rat.Found in brain, to generate and to secrete the chemical substance of the similar morphine of multiple effect afterwards at the electric pulse stimulation that applies low frequency and high frequency on the acupuncture point, enkephalin that low frequency electroacupuncture discharges (5 aminoacid are formed) and endorphins (31 aminoacid are formed), what high frequency discharged is dynorphin (17 aminoacid are formed).If use low frequency and high frequency, then can make above-mentioned three kinds of materials is that enkephalin, endorphins, dynorphin discharge simultaneously, brings into play the strongest analgesic activity.This serial experiment has tentatively disclosed the principle of acupuncture analgesia." the Han Shi acupoint stimulation instrument (HANS) " of inventor's development, be called for short the Han Shi instrument, the certain electric pulse that it sends both can stimulate by the metal needle that thrusts in the acupuncture point, also can the surface of electrode paste at point skin be made electric current see through skin and enter the acupuncture point.Under one situation of back, use, can remove acupuncture treatment from, and reach same therapeutic effect, be called as " the acupuncture and moxibustion instrument of needleless." 1980 years World Health Organization (WHO)s once proposed 43 kinds of diseases and can treat with acupuncture and moxibustion treatment; according to present data, every acupuncture can be treated, and the Han Shi instrument also all can be treated; thus simplified the application of acupuncture and moxibustion treatment greatly, quickened acupuncture and moxibustion treatment and applied global.How the effect of acupuncture analgesia is expressed quantitatively, it is a learned difficult problem, one of its reason is that the maneuver of acupuncture has nothing in common with each other, be difficult in addition standardization, the application of Han Shi instrument is resolved this problem, because the frequency of this instrument output pulse, electric current wave mode, time are all with digital accurate demonstration.
From maincenter neuro chemistry angle, systematic study acupuncture analgesia principle finds that acupuncture can mobilize intravital analgesia system, discharges opioid peptide, monoamine neurotransmitter etc., the performance analgesic activity; The electricity irritation of different frequency can discharge the variety classes opioid peptide; The quality that pin is imitated depends on the growth and decline of easing pain in the body and resisting two kinds of strength of analgesia.The achievement in research that these are advanced in the world has obtained the high evaluation of international scientific circle, has obtained great success, has advanced the development of neuroscience, has promoted acupuncture and moxibustion treatment and has gone to the world.
The existing pulse width of general instrument output both at home and abroad all is constant, constant as pulse amplitude, increase frequency is after 15Hz, because of boost pulse overstocked, muscle shrinks with impulse stimulation, but do not have the enough time and loosen and get back to original position, adjacent pulse finally becomes pain tetanic (spasm) unbearably to the stack of muscular irritation.Pulse frequency increases, and its stimulus intensity increases thereupon.
But the setting of the needle-free pain-relieving instrument of needleless and instrument also do not have open.Comprise that the method and apparatus that the human body vegetative nerve stimulates does not also have open.
Summary of the invention
The present invention seeks to: the setting and the instrument that propose a kind of needle-free pain-relieving instrument of needleless, especially in conjunction with the method for oriental medicine and western medicine treatment pain, a kind of needle-free pain-relieving instrument product of needleless is proposed, this instrument adopts microcontroller to operate the overall process of all treatment parameters and control treatment, and be shown to the user by liquid crystal display screen etc., the user can be accomplished precisely and in real time to the operation of this product.Remove misery for the Persistent Pain patient simultaneously.Especially also be applied to the human body vegetative nerve is produced the method and apparatus of useful stimulation.
The present invention seeks to realize like this: the method to set up of needle-free pain-relieving instrument, it is the electric pulse stimulation signal that needle-free pain-relieving instrument adopts the dilatational wave that is output as 2Hz low frequency and high frequency 100Hz ± 10Hz, electric pulse stimulation signal and export in the constant-current source mode, implementation is: the signal of low frequency and high frequency produces by (two-way) pulse-width modulation PWM signal respectively, and, also can be the low frequency and the high-frequency signal of single channel output checker from the continuous adjustable output of 0-5V.
The specific embodiment that realizes invention is opening of other gauge tap pipe and turn-offs the generation pulse signal, utilizes operational amplifier to amplify, and according to working power and current transformer, produces positive and negative alternative constant current, and two paths of signals is independent mutually.
Output of the present invention is: the persistent period of every kind of frequency is that the design of 3s ± 0.5s has good effect.
The present invention exports in the constant-current source mode, guarantees that therapeutic effect is not different because of skin resistance difference; Preferred waveform can make three kinds of morphine attitude materials that have analgesic activity in the nerve discharge simultaneously, brings into play the strongest analgesic effect.In addition when frequency raises, pulsewidth narrows down automatically, become typical " TENS " waveform, so this product can have the advantage of " TENS " and acupuncture concurrently, also have multinomial innovation parts such as timing shutdown, zero output are shut down automatically, battery electric quantity shows, locking button, back lighting except above main this machine of characteristic, be that the user can arbitraryly operate machines, thereby make therapeutic effect reach best.
The formation of needle-free pain-relieving instrument of the present invention comprises microcontroller, mixed signal, and be used to control the control of output waveform, Frequency and Amplitude and pulsewidth, the response button drives formations such as LCD demonstration, operational amplifier; Q3, Q4, Q5 (audion), D4 (the linear pipe of adjusting), S6 (switching tube) forms power circuit, gauge tap pipe and voltage transitions, in addition the gauge tap pipe open and turn-off the generation pulse signal, and utilize operational amplifier to amplify, according to working power and current transformer, produce positive and negative alternative constant current, two paths of signals is independent mutually.Microcontroller produces two independent pwm signal (PWM_A, PWM_B), forms the voltage signal of 0-5V through capacitance-resistance low-pass filtering (R16, R17, R18, R19, C1, C2).Connect the mos switch again through low-pass filtering, the switching signal of microcontroller accurate timing signal (CP1, CP2) as 4066 also is admitted to simultaneously, 4066 output treatment waveform (PWM_A_L/R, PWM_B_L/R) signals, and concatenation operation amplifier D22 output is amplified, recommend audion Q1, Q2 or Q6, Q7 through two groups again and take turns conducting, recommend audion for two groups and export current transformer D3, D5 to, the output of current transformer produces the impulse wave at positive and negative interval.
Characteristics of the present invention are: multinomial studies show that, in surgical operation, use the dilatational wave of the present invention's output, and can make the narcotics consumption reduce 40-50%, in the control of postoperative pain; Vegetative nerve had good stimulation.The application of the inventive method also can make the analgesic consumption reduce more than 40%.This is a kind of quantitative method for expressing, can verify on science.The present invention has condensed the theory in more than 40 year of inventor and academic research.
Instrument of the present invention also has following characteristics: 1) computer is accurately controlled and is shown all stimulus parameters:
Accurately control all stimulus parameters by computer hardware and software and peripheral benchmark, full button operation, user can make things convenient for and regulate exactly, and data quantitatively show with number, meet general international standard, and the scientific research result can have international exchanges without barrier.Overcome current all can't provide rationally and accurate quantitative defective with quasi-instrument.
2) the peak point current metering is adopted in the output pulse, adopts constant-current circuit output:
No matter with skin or the treatment of acupuncture needle electrode the time, its stimulus intensity all with the pulse peak current metering, meets international electrophysiological measuring requirement.For guaranteeing that the pulse peak current value adopts special constant current output circuit not because of the resistance variations that factors such as body polarization cause changes in the stimulating course, guarantee that output current is invariable.Overcome current all do not have quantitatively with quasi-instrument or wrong be measurement unit with voltage, can not ensure the constant defective of output current simultaneously.
Constant current output circuit not only makes by the expanding of stimulating acupoint, heavy feeling of qi strong, the epidermis twinge of also having avoided the spike of the non-constant current output circuit of common instrument to cause.
3) adopt symmetric two-way rectangular wave pulse fully:
Guarantee that quantity of stimulus is identical under the paired electrode.Thoroughly eliminate common instrument and adopted two-way asymmetry pulse, under paired electrode, the asymmetric common fault of stimulus intensity.And the flip-flop of guaranteeing electricity irritation is zero, stopped some instrument and caused the acupuncture needle accident of broken needle in vivo.
4) with research in surplus the acupuncture analgesia 40 year elite---preferred 2/100Hz dilatational wave is used for clinical:
Adopted 2/100Hz (hertz) dilatational wave, the three kinds of morphine class materials (endorphins, enkephalin, dynorphin) that have the analgesia function in the nervous system are discharged simultaneously with specified time interval.By three's synergism, given play to the most intensive analgesic effect.The effect of this waveform obtains the proof that repeats of foreign study, adopted by Europe, and called after HANS ripple.
5) ripple is wide changes automatically with frequency, guarantees that the 2/100Hz dilatational wave of characteristic of the present invention is achieved:
The quantity of stimulus of certain intensity electric pulse row had both depended on the width of individual pulse, also determined in the superposition of adjacent pulse stimulation---frequency.When frequency raise, pulsewidth should narrow down automatically, and when frequency reduced, ripple is wide should to broaden automatically, just can make the frequency range of low (2Hz) and high (100Hz) that close quantity of stimulus is all arranged.Narrower pulsewidth is typical simultaneously " TENS " (transcutaneous electric nerve stimulation) waveform; Broad be again typical " acupuncture sample " waveform.Therefore when adopting 2/100Hz density alternating wave, needle-free pain-relieving instrument of the present invention (therapeutic instrument also claims the Han Shi instrument) can have the advantage of TENS and acupuncture concurrently.Ripple wide with frequency automatically the application of change technique overcome front end that common instrument adopts fixed pulse width to bring and crossed strong or low frequency end is crossed the weak discomfort of feeling, be world's initiative.
Description of drawings
Fig. 1 needle-free pain-relieving instrument system structure sketch map
Fig. 2 needle-free pain-relieving instrument control section circuit structure diagram
Fig. 3 needle-free pain-relieving instrument simulation part parallel circuit structure chart
Fig. 4 needle-free pain-relieving instrument software flow pattern
The object or the result schematic diagram of three kinds of different rectangular pulse effects of Fig. 5
Fig. 6: asymmetric bidirectional pulse signal schematic representation
Fig. 7: two kinds of symmetric double are to the electric impulse signal sketch map
Fig. 8 rectangular pulse signal sketch map
Fig. 9 equivalence is the network that resistance and electric capacity are formed, by the unpolarized condition equivalence of nerve fiber
During the power supply of Figure 10 constant voltage, transient resistance increases makes stimulating current decline sketch map
Figure 11 sketch map of the electric pulse of constant voltage and constant current in addition on skin surface
The specific embodiment
Referring to electrical schematic diagram (Fig. 2, Fig. 3)
Circuit board mainly is responsible for the control of generation, waveform frequency amplitude and the pulsewidth of waveform on Fig. 2, and LCD shows and button processing etc., and Fig. 3 is the mainly conversion, electric current amplification, positive and negative waveform generation, switching on and shutting down control etc. of responsible electric current and voltage of circuit board down.
Microcontroller D1 adopts the EM78P468N of Taiwan Elan among Fig. 2, and 8 mixed signal single-chip microcomputers are used to control the control of output waveform, Frequency and Amplitude and pulsewidth, and the response button drives LCD demonstration etc.
Q3 wherein, Q4, Q5 (audion), D4 (the linear pipe of adjusting of 78L05), S6 (switch) forms power circuit charge control switch machine and voltage conversion circuit, when the S6 Q3 conducting that is pressed, D4 changes out 5V voltage, and microcontroller is powered on and starts working, and keeps the Q3 conducting, the time that microcontroller detection S6 is pressed when needs shut down reaches certain duration and turn-offs Q4 by HOLD_t later on, and Q5 and Q6 make the power remove of entire machine.The start back is by regulating S1-S4 among Fig. 1, microcontroller produces two independent pwm signal (PWM_A, PWM_B), through low-pass filtering (R16, R17, R18, R19, C1, C2) voltage signal of formation 0-5V, the Current Regulation of complete machine has 40 grades, so one grade of output microcontroller of every increase pulse-width signal output after filtering, increasing 0.125V, signal is sent into mos switch (4066 then, D11 among Fig. 2), microcontroller calculates the signal (CP1 of output through inner accurate timing simultaneously, CP2) also be admitted to as 4066 switching signal, adjusted pulse-width signal has become initial treatment waveform (PWM_A_L/R on sequential, PWM_B_L/R), signal is through operational amplifier D22 output amplification afterwards, pass through audion Q1 at last, Q2 or Q6, Q7 takes turns conducting also by special current transformer D3, D5 has just produced the impulse wave at positive and negative interval, and form different frequency (2Hz, 15Hz, 50Hz, 100Hz etc.), pass through CON1 at last, lead and electrode slice that CON2 connects form final treatment waveform.
Accurate voltage comparator im393 is responsible for monitor voltage in addition, and when supply voltage was lower than normal voltage, microcontroller can be made corresponding processing, and the user can in time change battery.
1, the research of periodic control technology, exploitation:
The present invention utilizes specific output waveform, adopts contemporary software for calculation technology, has designed the proprietary software with independent intellectual property right, two intervalometers of control microcontroller inside, the real-time clock as the overall situation, the intervalometer as frequency shift.
Real-time clock comprises the keyboard lockout timing as the timing that global clock is used for entire machine, time-delay timing backlight, shutdown timing automatically, key scan etc.;
Intervalometer is as the frequency shift timing, and controlled frequency is the mutual alternative time at interval, and this time specifies according to Korea Spro's formula waveform.
2, ripple is wide changes automatically with frequency and preferred dilatational wave:
When frequency raise, ripple is wide to narrow down automatically, became typical " TENS " (transcutaneous electric nerve stimulation) waveform; When frequency reduced, ripple is wide to broaden automatically, and becoming typical " acupuncture sample " stimulates.
Especially 2/100Hz (hertz) dilatational wave that has specified time interval can make the three kinds of morphine class materials (endorphins, enkephalin, dynorphin) that have the analgesia function in the nervous system discharge simultaneously.By three's synergism, given play to the most intensive analgesic effect.
Study validation trial through the inventor at acupuncture analgesia, the most effective stimulus parameter is exactly 2Hz, 100Hz and 2/100Hz; Morphine peptide, enkephalin and three kinds of endogenous morphines of endorphins in 2Hz can excite and produce in brain and the spinal cord; 100Hz produces this a kind of endogenous morphine of dynorphin.Especially the mutual alternative dilatational wave of two kinds of frequencies of 2/100Hz (DD ripple) can produce 4 kinds of endogenous morphines simultaneously.Human body and zoopery show that every 3s ± alternative design in 0.5s second meets the endogenous morphine requirement of (neurotransmitter) half-life most, can obtain optimum efficiency.
In order effectively to utilize the use of multiple waveform in acupuncture and physical therapy, 2,4 lead instrument provides following waveform respectively:
Figure A20071002106100071
Under the ■ different frequency, automatic regulating impulse width
If general instrument exports 2 and the alternative dilatational wave of 100Hz, frequency differs 50 times, is difficult to operate as normal.For making the 2/100Hz energy operate as normal that exchanges automatically preferred per 3 seconds, the present invention (Han Shi) instrument product has adopted under different frequency, and the self-regulating technology of pulse width is when frequency raises, pulsewidth narrows down automatically, when frequency reduced, pulsewidth broadened automatically, had realized under frequency differs 50 times situation, automatic adjusting to stimulus intensities such as human muscles, guarantee that 2Hz and 100Hz can both effective stimuluss, realize discharging 4 kinds of endorphinss simultaneously that this is a kind of design of innovation.
Its design is as follows: the stimulus intensity of each electric pulse depends on the width and the amplitude of pulse, and the increase of width or amplitude all makes to stimulate to strengthen.The electric pulse also muscle under the counter electrode produces and stimulates, when 2Hz stimulates, and visible muscle contraction and beating of returning, pulse strength is big more, and it is big more to beat.
50 times of the frequency discontinuities of 2/100Hz dilatational wave of the present invention, if pulsewidth remains unchanged, stimulus intensity will differ greatly.In other words, if pulse amplitude satisfies the stimulus intensity of 2Hz rightly, when transferring 100Hz to, must misery unbearably.Otherwise if intensity is suitable when 100Hz, when forwarding 2Hz to, intensity will be uselessly very low.Only under different frequency, the regulating impulse width just makes 2/100Hz dilatational wave operate as normal automatically.
■ has the advantage of acusector (EA) and transcutaneous electric nerve stimulation (TENS) simultaneously
The characteristics such as the following table of acusector (EA) and transcutaneous electric nerve stimulation (TENS):
Acusector EA TENS
Electrode area Be needled into the acupuncture point, on pin, switch on Electrode places skin surface
The nerve fiber that stimulates Middle fiber (A β+A δ) is main Crude fibre (A α+A β) is main
The electricity irritation ripple is wide Broad (0.3-1.0ms) Narrower (0.1-0.2ms) gets final product
The electricity irritation frequency Be generally low frequency (2-4Hz), in fact also available high frequency Be generally high frequency (100-200Hz), in fact also available low frequency
Therapeutic instrument series of products of the present invention have both characteristics concurrently.When frequency raise, pulse width narrowed down automatically, became typical " TENS "; When frequency reduced, pulse width broadened automatically, became typical " EA ".Therefore has the advantage of TENS and EA simultaneously.
When using EA, acupuncture needle thrusts body, and required stimulating current is far below TENS.Therefore we use desk-top 4 of design to lead instrument for actual, and output intensity is divided into two grades of " pin ", " skins ", and the former maximum intensity is 10mA, and the latter is 50mA, no matter which kind of electrode all can obtain careful, comfortable adjusting with.
3, symmetric double is to electric pulse Study on Technology, exploitation:
Unidirectional rectangular pulse, its electric current flows into and the outflow body through pair of electrodes (acupuncture needle, skin electrode), constitutes complete loop.Pulse current inflow place is an anelectrode, and outflow place is a negative electrode, and the nerve fiber under the negative electrode is just stimulated to produce excitement, does not produce excitement under the anelectrode.Unipolar pulse current is one-way flow always, so only cause stimulation at the negative electrode place, another anelectrode only plays conduction and serves as indifferent electrode, does not have therapeutical effect, the utilization rate of electrode be 50% (among Fig. 5 shown in the A) referring to the result of three kinds of different rectangular pulse effects of Fig. 5.
General instrument is for reducing cost, simplify circuit, send positive and negative asymmetric bidirectional pulse (shown in Figure 6), promptly form by unidirectional irregular rectangular wave pulse and reciprocal spike, the shape of two pulses and amplitude are all asymmetric, often cause the stimulation of two electrodes: one has a nothing, or a little less than the last one one, use inconvenience, impact effect.
" symmetric double is to electric pulse " has two rectangle electric pulses alternation that size is identical, direction is opposite, two electrodes of circuit serve as the positive and negative utmost point in turn, alternately obtain the stimulation of same intensity, do not have the problem of " has a nothing; the last one one is weak ", and the utilization rate of electrode is 100%.Therapeutic effect is doubled.
The present invention adopted two kinds of different symmetric double to electric pulse shown in B and C among Fig. 5 and Fig. 7.
Wherein " B " waveform is used for 2 and leads (electrode) and 4 and lead (electrode) two kinds of (Han Shi) instruments, and during work, two electrodes serve as negative pole in turn, and producing stimulates.If during 2Hz work, can feel that two electrodes are not that stimulation is arranged simultaneously, but alternately stimulate (shown in B among Fig. 5).One-period is: the frequency interval time through waveform after each pulse positive pulse produces a negative pulse, with this successive stimulus waveform of generation cycle; With 2Hz is example: i.e. the stimulation that obtains of each electrode is 1Hz, and the stimulation of passing to maincenter is the common result of two electrodes.Be still 2Hz.
Wherein " C " is newly-designed rectangular pulse, be used for 4 and lead the Han Shi instrument, each pulse " preposition just " pulse produces at electrode to stimulate, the tailing edge of " preposition " pulse follows " follow-up negative " pulse closely, " preposition just " pulse is with " " pulse becomes a stimulus waveform to follow-up bearing, and produces successive stimulus waveform of cycle through the frequency interval time of waveform; It produces at another electrode stimulates (shown in C among Fig. 7), and it stimulates efficient to double than " B " waveform.It is the most effective rectangular pulse.Because two electrodes transmit information to maincenter simultaneously, and stack potentiation is arranged, clinical practice shows, can improve curative effect.Waveform is square wave preferably.
Front and back have the rectangular pulse of certain hour interval and current amplitude along precipitous, are easy to accurately quantitative and control, make excited nerve fiber generation excitement and conduction.The electrophysiological stimulation device first-selection that Neuroscience Research is used is a rectangular pulse, becomes this first-selection naturally.
During the work of rectangle electric pulse, only in the moment power consumption of exporting pulse, all the other time not power consumptions substantially, special power saving is fit to battery powered and portable domestic, also favourable safety.
4, constant current output:
Utilize the PWM mode, quantize output voltage and make button can accomplish even regulation, make voltage signal convert current signal to by wave filter and precision amplifier.
The electrical characteristics of human body under acupuncture and the skin electrode:
Under pin and two kinds of different conditions of percutaneous, the electrology characteristic of body differs greatly, to the requirement difference of instrument.Position, the depth of acupuncture treatment.The position of skin electrode, size, do wet, climatic environment, temperature or the like, all influence the electrical characteristics of stimulation object.Through measuring,, can equivalence be the network (shown in Figure 10) that resistance and electric capacity are formed through the tissue of pin or percutaneous, its structure is identical, but parameter has very big-difference, and is as shown in the table, and wherein T is time constant (R1 * C), the time constant of percutaneous (T) is than little 10-20 times through pin, show that under same voltage effect the charging rate of percutaneous electrode lower body polarization capacity is than through the fast 10-20 of pin doubly, the transient resistance that is body tissue can increase rapidly, and slower through pin.In constant voltage when power supply,, transient resistance increases descends (Figure 11) stimulating current, and for keeping the effective stimulus electric current, the percutaneous stimulation instrument is defeated goes out circuit and should have constant-current characteristics, makes the increasing of design and manufacture difficulty.
R1(KΩ) R2(KΩ) C(MF) T(ms)
Pin 0.25 2.5 41
Skin 1 1.1-10 0.1 0.05-0.1
Constant voltage and constant-current pulse output: in the market, it is adjustable that the defeated characteristic of acusector and transcutaneous electrostimulation instrument has the voltage amplitude of two quasi-instruments output pulse, in case after voltage amplitude is determined, no longer become with load, is called " constant voltage output " (abbreviation constant voltage).But its output current will change with body changes in resistance between electrode.During the application skins based upon bidding electrode, electric current flows into body through skin, the permeability of keratodermatitis is poor, hinders ion flow, and negative ions is piled up in the both sides, barrier layer, cause polarization, skin resistance increases 2-10 doubly in the 0.05mS (5/100000ths seconds) after energising, pulse current drops to and is original 1/2-1/10, forms point and narrow pulse current, very easily cause the epidermis twinge, be difficult to accept.The width of instrument pulse commonly used, though be 0.2-1ms (2/10000ths to signa), under the constant voltage mode, the time of real useful effect is less than 0.05mS.So the instrument of constant voltage output is unsuitable for the stimulation through the skin electrode.When acupuncture needle stimulates, polarization takes place slower, body resistance increases slow slightly, though the paired pulses electric current is still influential, available pulsewidth 0.5-1ms is with interior constant pressure impulse, therefore, the constant voltage instrument only should be used for less demanding electroacupuncture treatment, must not be used for the accurate quantitative scientific experiments research of requirement.
In addition the result of the test of the electric pulse of constant voltage and constant current is as shown in figure 11 on skin surface: during constant voltage output, form tangible spike electric current.Shown in Figure 11, the current amplitude of instrument output pulse is adjustable, in case after current amplitude is determined, no longer become with load, is called " constant current output " (abbreviation constant current).Empirical curve shows, though the skin polarization causes resistance to increase, but pulse current value is constant, guarantees steady operation, and the Han Shi instrument is constant current output, and electric current can accurately quantitatively be controlled.The forward position of pulse current is excessively slick and sly, and depth of interaction is big, and scope is wide, the expanding of acupuncture point, heavy, feeling of qi is strong because no sensation of pricking feels comfortable, the patient is easy to accept bigger stimulus intensity, is particularly conducive to the treatment that excites endogenous morphine.The constant current instrument can fully satisfy percutaneous stimulation, more can satisfy the needs of acusector naturally.The constant current instrument performance is superior, circuit structure is complicated, and price is more expensive.The electrophysiological stimulation device all adopts constant current output, when the scientific research of acupuncture point nerve electric stimulation and clinical practice, be measurement unit all in the world with the pulse current peak, require instrument to have Exact Number to show, guarantee the objective and accurate of scientific research and use, can repeat, can compare.Above-mentioned requirements has only under the constant current working method and could realize.
4, this instrument has adopted the software engineering of The present computer technology, liquid crystal display, cell phone appearance design, man-machine friendly interface, gives people's outward appearance smoothness, attractive in appearance, practical profile, characteristics easy to use, is convenient to the general population and uses.Instrument meets the technical parameter of general international standardization, with number accurately quantitatively, control, show.With the various symptom of accurate quantitative treatment parameters.
Passed through the clinical practice of how tame hospitals such as China-Japan Friendship Hospital, Beijing Obstetrical and Gynecological Hospital, Beijing Hospital, Tiantan Hospital, clinical practices such as Shanghai acupuncture and meridian institute, Wuhan Concord Hospital, Zhuhai Ruihua Detoxification And Rehabilitation Center have obtained significant effect.
5, technology 1) instrument adopts current cell phone appearance designing technique, simple and direct, full, mellow and full form; The tundish circle of silver lustre upper and lower covers and dark metal texture; Exquisite, personalized operation push-button design; Independently the LOGO label is placed with the model that eyeglass is unified; Body is enriched on recessed socket plane; Side's row that protrude at the back supports body and presents placement angle.2) instrument internal adopts current popular SMT surface mounting technology, than traditional handicraft great raising is arranged on integrated level, reliability.3) in strict accordance with the requirement of YYT0287-2003 idt ISO13485:2003 standard, formulated strict flow process from product enterprise planning, product development, buying, production, check, storage etc.
In a word: needle-free pain-relieving instrument of the present invention can be extenuated pain even thoroughly be cured pain disease.
Pain is not only brought great misery to the patient, but also systems such as nervus centralis, circulation, breathing, endocrine, digestion and autonomic nerve are caused harmful effect, therefore removes the important process that pain is the treatment painful diseases, also is patient's fundamental right.Medical circle has been regarded as pain the mankind after breathing, pulse, body temperature and blood pressure " the fifth-largest vital signs " and has been paid attention to, and chronic pain is taken seriously as a kind of disease.Since ancient times, people are just seeking the reason and the Therapeutic Method of pain always, along with social economy and cultural development, and the improving of human survival quality, people increase day by day to the needs of pain therapy.The Han Shi needle-free pain-relieving instrument succeed in developing and enter family, alleviating pain and treatment pain have been started the beginning, be the historical milestone of pain.
Needle-free pain-relieving instrument product of the present invention will promote acupuncture and moxibustion treatment and go to the world
Acupuncture has been used thousands of years in China, has only history decades in the west, and how to carry out among the people, does not enter mainstream health care, does not also formally include within the project of social medical insurance payment.But because nearly 20-30 comes determined curative effects such as acupuncture treatment pain, principle is illustrated gradually, has eliminated certain mystique, has increased scientific credibility, therefore obtains the attention of international medical community gradually.The Han Shi instrument is as the acupuncture and moxibustion instrument of needleless, and is repeatable strong because its stimulus parameter is clear and definite, uses standardization, is easy to grasp, and can make huge contribution for acupuncture and moxibustion treatment goes to the world from advantages such as line operates under simple the guidance.
The present invention is according to the requirement of YY 0016-1993 (low-frequency electronic pulse therapeutic instrument), develops, checking etc., and main pilot project has: 1) the experimental enviroment ambient temperature is 5 ℃-40 ℃.Relative humidity≤80%.2) visual examination: observe 3) electric property check: electrical apparatus test project with eyesight.

Claims (10)

1, the method to set up of needle-free pain-relieving instrument, it is characterized in that it is the electric pulse stimulation signal that the needle-free pain-relieving instrument adopts the dilatational wave that is output as 2Hz low frequency and high frequency 100 ± 10Hz, electric pulse stimulation signal and export in the constant-current source mode, implementation is: the signal of low frequency and high frequency produces by the two-way pwm signal respectively, and, also can be the low frequency and the high-frequency signal of single channel output checker from the continuous adjustable output of 0-5V.
2, the method to set up of needle-free pain-relieving instrument according to claim 1, it is characterized in that output is: per 3 ± 0.5 seconds are 2Hz low frequency and high frequency 100 ± 10Hz waveform of output alternately.
3, the method to set up of needle-free pain-relieving instrument according to claim 1, when it is characterized in that frequency raises, pulsewidth should narrow down automatically, and when frequency reduced, ripple is wide should to broaden automatically, made the frequency range of low frequency 2 Hz and high frequency 100Hz that close quantity of stimulus all be arranged.
4, the method to set up of needle-free pain-relieving instrument according to claim 3 is characterized in that the wide scope of ripple is: broad is 0.3-1.0ms and and narrower 0.1-0.2ms.
5, the method to set up of needle-free pain-relieving instrument according to claim 1, it is characterized in that adopting two kinds of different symmetric double to replace stimulus waveform to electric pulse: 1) one-period is: the frequency interval time through waveform after each pulse positive pulse produces a negative pulse, with this successive stimulus waveform of generation cycle; 2) each pulse " preposition just " pulse produces at electrode to stimulate, the tailing edge of " preposition " pulse follows " follow-up negative " pulse closely, " preposition just " pulse is with " " pulse becomes a stimulus waveform to follow-up bearing, and produces successive stimulus waveform of cycle through the frequency interval time of waveform.
6, the needle-free pain-relieving instrument comprises mixed signal, and is used to control the control of output waveform, Frequency and Amplitude and pulsewidth, and the response button drives microcontroller, operational amplifier formation that LCD shows; The control voltage transitions, (Q3, Q4 Q5) form power circuit with linear adjustment pipe (D4) and switch (S6) to the audion that produces pulse signal of opening and turn-off of gauge tap pipe; It is characterized in that microcontroller output two independent pwm signal (PWM_A, PWM_B), form the voltage signal of 0-5V through capacitance-resistance low-pass filtering (R16, R17, R18, R19, C1, C2); Connect mos switch (4066) again through low-pass filtering, microcontroller accurate timing signal (CP1, CP2) also is admitted to as the control signal of mos switch simultaneously, mos switch (4066) output treatment waveform (PWM_A_L/R, PWM_B_L/R) signal, and concatenation operation amplifier D22 output is amplified, recommend audion Q1, Q2 or Q6, Q7 through two groups again and take turns conducting, recommend audion for two groups and export current transformer D3, D5 to, the output of current transformer produces the impulse wave at positive and negative interval.
7, needle-free pain-relieving instrument according to claim 6 is characterized in that the analog input adjustable side of microprocessor is provided with 40 grades of current regulating resistance devices, one grade of output of every increase, microcontroller pwm signal output increasing after filtering 0.125V.
8, needle-free pain-relieving instrument according to claim 6 is characterized in that being provided with and monitors supply voltage comparator (393).
9, needle-free pain-relieving instrument according to claim 6 is characterized in that controlling two intervalometers of microcontroller inside, the real-time clock as the overall situation, the intervalometer as frequency shift.
10, needle-free pain-relieving instrument according to claim 6 is characterized in that the instrument output intensity is divided into two grades of " pin ", " skins ", and the former maximum intensity is 10mA, and the latter is 50mA.
CN 200710021061 2007-03-23 2007-03-23 Needle-free pain-relieving instrument and its setting method Pending CN101069769A (en)

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CN102058935B (en) * 2010-12-24 2013-09-18 东莞市南星电子有限公司 Medical electronic acupuncture instrument and control method thereof
CN102579042A (en) * 2012-03-06 2012-07-18 复旦大学 Multilevel constant-current pulse generating circuit
CN102580238A (en) * 2012-03-06 2012-07-18 复旦大学 Multilevel high and constant voltage pulse generator circuit
CN102579042B (en) * 2012-03-06 2014-02-19 复旦大学 Multilevel constant-current pulse generating circuit
CN102580238B (en) * 2012-03-06 2014-06-11 复旦大学 Multilevel high and constant voltage pulse generator circuit
CN105395311A (en) * 2014-08-15 2016-03-16 土井瞳 Device for promoting blood circulation through heat and electric shocks and use method thereof
CN105395311B (en) * 2014-08-15 2017-12-01 土井瞳 The device and its application method to be stimulated circulation with heat and electric shock
CN104784821A (en) * 2015-04-24 2015-07-22 山东威高集团医用高分子制品股份有限公司 Electronic equilibrium auxiliary anesthesia instrument
CN105771086A (en) * 2016-03-21 2016-07-20 浙江中医药大学 Acupoint electrical stimulation method and device for assistant analgesia
CN106038247A (en) * 2016-06-28 2016-10-26 浙江中医药大学 Electrical acupuncture point stimulation method and device based on continuous wave
CN106178253A (en) * 2016-06-28 2016-12-07 浙江中医药大学 A kind of electric acupoint stimulation method and device based on dilatational wave
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