AU627691B2 - Electrostimulating device - Google Patents

Description

r- Ia PCT WORLD DPI DATE 11/08/89 APPFLN. ID 17064 88 AOJP DATE 07/09/89 PCT NUMBER PCT/BR88/00005 INTERNATIONAL APPLICATION PCu u I I\n I i I (51) International Patent Classification 4 (1l) International Publication Number: WO 89/ 06554 A61N 1/32, 1/34, 1/36 Al (43) International Publication Date: 27 July 1989 (27.07.89) (21) International Application Number: PCT/BR88/00005 Published With international search report.

(22) International Filing Date: 28 April 1988 (28.04.88) (31) Priority Application Number: PI 8800201 (32) Priority Date: 21 January 1988 (21.01.88) (33) Priority Country: BR (71X72) Applicant and Inventor: GIORDANI, Antonio, IIson [BR/BR]; Rua Coronel Jose Eusebio no 73, Consolag o, 01239-Sdo Paulo, SP (BR).

(81) Designated States: AT (European patent), AU, BE (European patent), CH (European patent), DE (European patent), FR (European patent), GB (European patent), IT (European patent), JP, KR, LU (European patent), NL (European patent), SE (European patent), SU, US.

(54) Title: ELECTROSTIMULATING DEVICE (57) Abstract The invention refers to a series of devices for medical, therapeutic and odontological treatments, which employ impulsetherapy or transcutaneous nervous electrostimulation as means of physical, rational and non-invasive relaxation of specific muscular areas: the developed basic Electrostimulating Device consists of a triangular signal generator followed by an amplifier which is connected to a modulation controller A squared signal generator (11) is connected to a first stage signal conformator which, in its turn, is parallely connected to a frequency divider to a final amplifier and to another 2 nd stage signal conformator and another final amplifier follows the latter. The referred frequency divider is also connected through a key of three positions B, C) to a 3 rd stage signal conformator and this one to a low frequency -ignal controller 'WO 89/06554 PCT/BR88/00005 1A- "ELECTROSTIMULATING DEVICE" FIELD OF INVENTION The present invention refers to an Electrostimulating Device for applications in medical and odontological fields.

More specifically, the invention deals with a series of devices for medical, therapeutic and odontological treatments, that employ impulse-therapy or transcutaneous nervous electrostimulation, also called "TENS", as means of physiological, rational and non-invasive relaxation of specific muscular areas.

BACKGROUND ART Pain accompanies mankind from his birth until the end of his life. Maybe, for this reason, one type of fear, among many which exist, also accompanies man throughout his life, the fear of pain.

In odontological treatment, for example, fear of pain is almost constant, in spite of the fact that the advances in modern dentistry have been able to soothe in an extraordinary way, the unpleasant sensations experienced by the patient. Tension and anxiety still remain and constitute factors that discourage many patients from going to the dentist's, afraid of the pain they might feel. This number is quite larger than those who evade due to many other reasons added together.

The search for solutions to diminish the "stress" of odontological patients has worried dentistry. The impulsetherapy or transcutaneous nervous electrostimulation "ENT" or "TENS", is an efficient method to achieve a physiological, rational and non-invasive relaxation, of specific muscular areas.

In 1975, Bernard Jankelson initiated studies on its applications in the odontological area, and developed a device, the "Myo-Monitor" of specific use in dentistry. Since then, many similar devices have been developed with the same purpose of relaxation and regulation of the musculature of the odonto-stomatognatic system. All of them utilize low frequency, fixed or variable (from 40 to 350 impulses per minute) to attain Uji I, WO 89/06554 PCT/BR88/00005, 2the proposed objetives. These devices, in spite of presenting results considered satisfactory, have several restrictions, due, mainly, to the adoption of a unique band of performance of the electrostimulating signals, the most critical being the i following: The high frequency applied separately promotes a fast analgesic and miorelaxing effect, however of low duration after its application.

The low frequency applied separately promotes analgesis, relaxation of longer duration, after application; however, it takes longer for the effect to initiate and, besides this, it provokes an unpleasant sensation in the patient.

The low frequency can only be utilized up to 300 pulses per minute, for above this it promotes muscular stress, which is a totally undesirable effect.

Disclosure of the Invention The developed electrostimulating device presents technical innovations, which resulted from experiences and research carried out with other miostimulating devices, which indicated that the incorporation of high frequency, modulated to high and low frequencies, isolated or superposed, improved appreciably the efficiency of the "TENS" results, in the treatment of the symptomatology of pain and in the musculature relaxation.

Thus, the following may bo pointzd Cut C thomain innovations of the electrostimulating device: Incorporation of the modulati of the low frequency pulses, in those of high frequency n frequency as well as in phase. Under these conditions the characteristics of the pulse length are kept stable nd adjustments are allowed regardless of intensity; Intro ction of the modulation of the high frequency signal by ther low frequency signal (in the range of 0,5 to 8,333 H which wave may be triangular or sinusoidal.

Internally he modulation may be adjusted between 0 to 100%.

Pract' 1 experiments indicated a modulation factor of 50% as h- ng of good efficiency in the impulsetherapy applications, li 2a.

The present invention provides an electrostimulating device adapted to provide electrical stimulation to the body of a patient in order to alleviate the sensation of pain, said device comprising a first signal generator for generating a high frequency signal, a second signal generator for generating a low frequency signal, modulation means for providing a modulated output signal which includes said high and said low frequency signals.

Thus, the following may be pointed out as the main innovations of the electrostimulating device: incorporation of tihe modulation of the low frequency pulses, in those of high frequency, in frequency as well as in phase. Under these conditions, the characteristics of the pulse length are kept stable and adjustments are allowed regardless of intensity; introduction of the modulation of the high frequency signal by another low frequency signal (in the range of 0.5 to 8.333 Hz), which wave may be triangular or sinusoidal. Internally, the modulation may be adjusted between 0 to 100%. Practical experiments indicated a modulation factor of 50% as being of good efficiency in the impulse therapy applications,

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WO 89/06554 PCT/BR88/00005 3due to the remnant effect of the continuous low frequency signal; and Combined utilization of the resources described above, which allows the therapeutic application of the three signals simultaneously.

Such innovations increase the field of application of the device, due to the combination of frequencies which it permits. Resulting from this, devices have been projected for odontological, physiotherapeutic and therapeutic applications, constituting a series of miostimulating devices.

For the obtention of the outlet functions, the electrostimulator consists of two generators of base time and associated circuits. One of the generators is destined to the generation of high and low frequency signals and the other, to the generation of the signal which constitutes the modulation.

The characteristic of the form of the outlet wave is of the squared alternated type or approximately squared in both alternances, or still, squared in one of the alternances (positive or negative) with or without exponential in the other.

Other possible forms of waves are: triangular, sinusoidal, double-phase or monophase type.

Each stimulus must have the pulse length adjustable from 60 to 20.000 microseconds and current limitation of a maximum of 50 milliamperes, and the signal that composes each stimulus may be of the unique type or the "burst" type.

Brief Description of the Drawings Fig. 1 diagram of blocks representing the functional structure of the electrostimulating device for odontological applications, representing the basic units which constitute it.

Figures 2, 3 and 4 diagrams of blocks representing the functional structures of different forms of the electrostimulating device, applied to other medical and odontological fields.

Figure 5 scheme of the basic circuit of the triangular signal generator unit, amplifying unit, modulation control unit and measuring unit.

Figure 6 scheme of the basic circuit of the i: i I

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WO 89/06554 PCT/BR88/00005 st squared signal generator unit, 1 stage signal conformator, e unit,dividing unit, 2 stage signal conformator unit, 3 stage signal conformator unit, low frequency signal controller unit, final amplification unit and outlet transformer unit.

Best Mode for Carrying Out the Invention In Figure 1 where the constitution of the device is shown for odontological application, including the basic units of all the others shown in figures 2, 3 and 4, it may be observed that the electrostimulating device includes a triangular signal generator followed by the amplifier which is connected to the modulation controller A'squared signal generator (11) which may also generate other wave forms, according to therapeutic needs, is connected to a 1 st stage signal conformator, which, in its turn, is parallely connected to a frequency divider to a final amplifier and to another 2 nd stage signal conformator and another final amplifier follows the latter. The referred divider is still connected through a key of three positions B, C) to rd a 3 stage signal conformator and this one to a low frequency signal controller. This device presents the following characteristics: Main applications: relaxation, and unprogramming of the chewing and facial muscles, mandibular monitoring and other electrotherapy applications in the facial region.

Technical functions: continuous high frequency (100 Hz), modulated high frequency (0,666 Hz modulation), low frequency (40 ppm, 100 ppm, 300 ppm), continuous high frequency juxtaposed by the low frequency, modulated high frequency juxtaposed by the low frequency.

Control: high frequency intensity, low frequency intensity, equilibrium, low frequency selector, continuous/modulated high frequency selector, turn-on/turn-off.

Outlets: two active poles, right and left, a diffusing pole.

In figure 2, the diagram of blocks of a I variant of the device is shown, which, as an example of the others, presents a basic structure similar to that of figure 1, Si wo 89/06554 PCT/BR88/00005 the main difference being the substitution of the divider (6) by a divider having characteristics different from those of figure i. The referred device has as main characteristics the following: Main applications: analgesia, muscular stimulation, cicatricial process activation, general electrotherapy.

Technical functions: continuous high frequency (100 Hz), modulated high frequency (0,666 Hz modulation), low frequency (80 ppm, 160 ppm, 300 ppm), continuous high frequency juxtaposed by the low frequency, modulated high frequency juxtaposed by the low frequency.

Controls: high frequency intensity, low frequency intensity, continuous/modulated high frequency selector, turn-on/turn-off low frequency selector.

Outlets: two or more positive poles, two or more negative poles.

Figure 3, shows the diagram of another variant of the device and its structure is generatedby the suppression of the low frequency controller of the 3 rd stage signal conformator and of the divider being 1 st and nd still possible the suppression of the s t and 2 stage signal conformators (10; 9).

This variant presents the following characteristics: Main applications: relaxation, analgesia, lymphatic drainage, cellular revitalization.

Technical functions: continuous high frequency (100 Hz), modulated high frequency (modulation with 0,666 Hz), where the low frequency modulation may also be added.

Controls: intensity, equilibrium, continuous/modulated, turn-on/turn-off high frequency selector.

Outlets: two active poles, right and left, a diffusing pole.

In figure 4, it is observed the diagram of the functional structure of the other version of the device, which unities are similar to those of the device in figure 3, however, being here suppressed the 1 and 2 stage signal ii ia WO 89/06554 PCT/BR8/00005 -6conformators and an inverter (12) is introduced in their place and connected to the final amplifier Its main characteristics are: Applications: analgesia, relaxation, stimulation.

Technical functions: continuous high frequency (100 Hz), modulated high frequency (0,666 Hz modulation).

Controls: continuous/modulated high frequency selector, Outlets: two poles, a positive and a negative one.

This device may also present a model with low frequency modulation.

Figures 5 and 6 associated,form the general basic circuit of the electrostimulating device of the invention, according to figure i.

In this way, it may be observed by figure that the developed device includes a generating unit of triangular signal, in which the high frequency modulation is of the "modulation by amplitude" type, with modulation frequency of 0,666 Hz, of the triangular or sinusoidal type. This unit contains an oscillator which consists of a CI-l circuit and other circuit supports, which is controlled by tension and with triangular (pin 4) and squared (pin 3) outlet wave. The adjustment of the frequency is achieved by R3 and C2. From the CI-l outlet, only the triangular signal (pin 4) is utilized for the feeding of the operational amplifier CI-2 of the inverter type with an approximate tenfold gain. The referred operational amplifier CI-2 varies the base polarity of the Q1 transistor of the modulation controller, by a variable resistor In the controller, the low frequency is controlled by means of variations in PI, Rll and Q2, associated to variations in Ql. These variations are cadenced with the above-mentioned frequency of the oscillator, thus obtaining the triangular or sinusoidal modulation of the high frequency signal, the percentual control of the modulation being obtained by the variable resistor RIO. A key S2 acts to impose or not the WO 89/06554 PCT/BR88/00005 7modulation, and when it is in the turned off position, the base of the Q1 transistor becomes positively polarized and it passes to conduct the current, allowing, in this form, to adjust the high frequency intensity by means of P1.

The visual control of the outlet signal (relative control) in Q2 and Q4 is carried out by instruments of the "VU" type, and the reading of the bottom of the scale is adjusted at high frequency by R23 and at low frequency by R24, R25 and R26, being selected by frequency in the Sl-C key, the low frequency pulses being amortized by P7 and C8 and, consequently, the visualization of the reading of the measuring instrument is greatly improved. This measurement may also be obtained with leds.

In figure 6, one may observe the squared signal generator, responsible for the high frequency stimuli, which is obtained by an oscillator composed by the integrated circuit CI-3.

This circuit, in the represented configuration, supplies an outlet signal in pin 3 in the form of a squared wave, resistors R12, R13 and capacitor C4 forming the time constant that determine the oscillation frequency. With resistor R13, which is of the variable type, the generator may be adjusted in the desired frequency.

The signal emitted by CI-3 is then sent to the 1 st stage signal conformator, which consists of a monostable circuit, formed by a logical part of the "NAND" type circuit and by two inverter circuits of the "Schmitt Trigger" type CI6-E and CI6-F, being that in this unit, resistor and capacitor C7 form the time constant that adjust the length of the pulse to be obtained at the outlet of transformer Tl.

~The referred monostable circuit is sensitive to the descent Slimit of the squared wave signal.

Pin 8 of the CI6-F circuit feeds a final amplifier with rectangular pulses of length defined by the referred monostable circuit and in the established frequency, as well as the second stage signal conformator and the frequency divider block The signal of the conformator stage I .y '4i WO 89/06554 PCT/BR88/00005 feeds, as stated above, the 2 n conformator stage that consists of circuits CI5-B, CI-C and C36-D and which outlet feeds, in its turn, a second final amplifier The referred final amplifiers 8) are transistorizedandin"Darlington" configuration (Q7, Q8, Q6 and being each one connected to one of the prime windings of the outlet transformer.

The outlet transformer is fed in its center by a continuous tension, which when added to the two sequential signals of the signal conformator stages, result in a reversion of the magnetic flow in the transformer, producing by induction in the secondary coils, an alternated signal of positive and negative semicycle lengths proportional to the lengths adjusted in the two monostable circuits. The variation of intensity of the outlet signal is obtained by the variation of the tension level that feeds the center of the transformer. This effect is achieved by the variation in P1 and in the base polarization of Q2.

The low frequency stimuli are obtained from the outlet of the 1 st stage signal conformator, circuits CI4-A and CI4-B forming the frequency divider circuits.

In reality, these circuits are synchronous meters of the binary type, the first circuit (CI4-A) is configurated to divide by 10 and in the second (CI4-B) circuit the subdivisions by 2,6 and 15 are selected, which permits to obtain the desired frequencies from the original frequency.

These pulses obtained from the divider circuit are selected by key Sl-a and sent to the 3 rd stage signal conformator, which constitution is identical to the previous ones (1 st and 2 nd) and formed by circuits CI6-A and CI6-B. In this conformating stage, the length of the pulse is adjusted by resistor R16, being obtained the double of time of the length of the pulse when compared to the 1 st and 2 nd signal conformator stages.

The outlet of the 3 rd conformating stage feeds transistor Q3 of the low frequency signal controller which conducts only the low frequency pulses. This transistor C OAL4 Q3 and potentiometer P2 form the potentiometer which commands ci' L WO 89/06554 PCT/BR88/00005 9 the polarization of Q4 which, by its turn, controls the tension level that feeds the circuit of the primary winding of the outlet transformer. As the low frequency pulses are obtained from the high frequency oscillator by means of potentiometers, they are always synchronized with the high frequency.

The developed device also has diodes D1 and D2 to block eventual inverse polarizations of transistors Q2 and Q4.

Thus, the high frequency outlet juxtaposed by low frequency is obtained, selected and with independent intensity controllers, whereas at the outlet of the device, an outlettransformer is placed, of the elevating-tension type, with two independent secondary windings and interconnected by the equilibrium potentiometer P3, which carries out the balancing of the stimuli applied to electrodes G and D, in contraposition to eventual differences of resistance of contact with the human skin.

The above description, as previously mentioned, is related to the basic electrostimulating device, shown in the diagram of blocks of figure i, which permits variations in the form of outlet signal measurement, in the form of feeding or still in the outlet stimuli of the alternated type with a semicycle in the form of squared wave and another in exponential form. Time controllers and many other resources may also be introduced in the device.

The functions presented at the outlet of the electrostimulating device according to the invention are: Continuous High Frequency: it is a signal with a double-phase or monophase wave form as has already been described, intensity adjustable from 0 to 100% with a frequency in the order of 100 Hz, which can vary from 50 to 5.000 Hz.

Low Frequency: it is a double-phase or monophase signal as already described, frequency adjustable in a range from 0,333 to 10 Hz (internally) and may be selected by the user in the frequencies of 0,666 Hz (40 ppm), 1,666...Hz I (100 ppm) and 5 Hz (300 ppm), such selected adjustments being i able to change according to the best utilization convenience.

t WO 89/06554 PCT/BR88/00005 The duration of the low frequency pulse is adjustable according to clinical needs.

The intensity is in the case continuously adjustable from 0 to 100%.

High Frequency with Superposed Low Frequency: consists of a signal as described for continuous high frequency and another as described for low frequency, existing in this case adjustments which are independent of intensity, where the low frequency signal should juxtapose the high frequency signal, and such juxtaposition, must occur synchronized in phase and frequency. This juxtaposition is achieved by the High Frequency modulation, where, in a repetitive and ajustable periodicity, a high frequency alternance has its intensity increased.

Conjugation of the Continuous High Frequency, Low Frequency and Modulated High Frequency: according to the characterization of the name itself, it consists of a combination of stimuli where the modulated high frequency is juxtaposed by the low frequency, whereas only the juxtaposition of the High Frequency and the Low Frequency is made in a synchronized form, which does not occur with the modulation signal and the low frequency signal, even if both have the same frequency.

The constituent devices of the miostimulating series which the invention refers to utilize the basic circuits projected for the odontological application device. This device, as well as the others may be commercialized in more than one model, that is "standard" or "Luxe", the models differing in their finishing, by complementary electronic circuits, such as time programmer, current meter, automatic turn-off, etc. By extension, the invention includes any device which principle of high and low frequency conjugation is applied.

All the devices consist of a feeding source for utilization in the commercial net of electric energy, being possible the fabrication for use with batteries or electric cells.

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Claims (4)

1. An electrostimulating device adapted to provide electrical stimulation to the body of a patient in order to alleviate the sensation of pain, said device comprising: a first signal generator means for providing a high frequency signal in the range of 50 to 500 Hz and a low frequency signal in the range of 0.333 to 10 Hz, a second signal generator means for providing a modulation signal in the range of to 8.333 Hz, combination means for providing a combined output signal which includes said high, said low and/or said modulation signals.

2. A device as claimed in claim 1, wherein the output signal comprises either said high frequency signal modulated by said low frequency signal, said low frequency signal modulated by said high frequency signal, or a combination of said low frequency signal, said high frequency signal and said modulation signal.

3. A device as claimed in claim 2, wherein said modulation signal is a triangular or sinusoidal signal.

4. A device as claimed in claim 1, 2 or 3, whe.,. n said modulation signal is modulated. A device as claimed in claim 3, in which the triangular signal emitted has a frequency modulation of the amplitude type, in the order of 0.666 Hz. S 6. An electrostimulating device as claimed in claim 1, substantially as herein S described with reference to the accompanying drawings. SDATED this 24th day ofJune, 1992. ANTONIO ILSON GIORDANI WATERMARK PATENT TRADEMARK ATTORNEYS THE ATRIUM 290 BURWOOD ROAD HAWTHORN VICTORIA 3122 AUSTRALIA A I"8