Process for Establishing an Electrostimulation Protocol for Headache Control, and the Respective Portable Electrostimulation Equipment for Headache Control Using Said Protocol

Abstract

Process and electrostimulation equipment employed in the control of headaches, said process predicting the development of an electrostimulation protocol in which the variation of electric pulse variation is made in a random manner to reduce the physiological phenomenon of nerve fiber accommodation upon stimuli; portable electrostimulation equipment, formed by an electrostimulation set and support is provided, the former consisting of a cylindrical compartment housing an electric circuit board and disposable coin-shaped lithium-ion battery, model CR20XX, in whose back face there are recesses, which house the respective electrodes, suitably covered by respective gel layers protected by removable protective sheets; the electrostimulation set being engaged with the medial longitudinal groove of the support, which configures the rail along which aid set is moved; the following internal components are also provided: Power source module, step-up regulator module, micro controller module, power supply seal module, boost source module, H-bridge module, and electrode output module.

Claims

1. A process for establishing an electrostimulation protocol for headache control characterized in that it provides a random variation of electrical pulse intensity, respecting the stimulation efficacy limits, wherein said random variation is comprised in the range of 10 V, and said electrical pulses exhibit a square wave shape, are monopolar, have a width (or duration) between 60 μs and 100 μs, and a frequency between 40 Hz and 70 Hz; and said electrostimulation protocol further involves the following steps: a) intensity ramp from 0V to 25V peak (with 500Ω charge), for 2 seconds; b) 1.sup.st continuous mode period, maintained for 5 minutes; c) 1.sup.st intermittent mode period, maintained for 2 minutes; d) 2.sup.nd continuous mode period, maintained for 5 minutes; e) 2.sup.nd intermittent mode period, maintained for 2 minutes; 3.sup.rd continuous mode period, maintained for 5 minutes; g) 3.sup.rd intermittent mode period, maintained for 2 minutes; h) end of the protocol, after 21 minutes and 2 seconds.

2. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that electrical pulse intensity varies randomly, preferably within the range of 5V.

3. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that the width (or duration) of the electrical pulses is preferably 80 μs.

4. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that the frequency of the electrical pulses is preferably 55 Hz.

5. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that it provides two electrostimulation modes, namely, continuous mode and intermittent mode.

6. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that pulse bursts are continuously applied, in a continuous mode, with duration from 500 milliseconds to 2 seconds, and with sequentially inverted polarity.

7. The process for establishing an electrostimulation protocol for headache control, according to claim 6, characterized in that said pulse bursts exhibit preferably a duration of 1 second.

8. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that, in the intermittent mode, pulse bursts lasting 1-4 seconds and with sequentially inverted polarity, with a time intervals between the pulse bursts, are applied in an intermittent fashion, wherein said interval lasts 1-4 seconds.

9. The process for establishing an electrostimulation protocol for headache control, according to claim 8, characterized in that said pulse bursts exhibit preferably a duration of 3 second.

10. The process for establishing an electrostimulation protocol for headache control, according to claim 8, characterized in that said time interval between the pulse bursts exhibits preferably a duration of 3 second.

11. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that it optionally discloses the simultaneous use of other strategies both to avoid nerve fiber accommodation, used together with the random variation of pulse intensity.

12. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that one of said strategy is the use of monopolar pulse bursts.

13. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that the other of said strategies is pulse burst polarity inversion.

14. The process for establishing an electrostimulation protocol for headache control, according to claim 1, characterized in that one of said strategy is the addition of intermittent stimulation modes.

15. A portable electrostimulation equipment for headache control using said protocol, wherein said equipment comprises two parts, an electrostimulation set itself, and a support, in which said electrostimulation set is installed, characterized in that said electrostimulation set comprises a cylindrical compartment formed by a front body, and a back cover which are engageable with one another and which houses an electrical circuit board and a coin-shaped ion-lithium ion battery, model CR20XX; wherein, on the outer back face of the cover there are recesses housing the respective electrodes, covered by the respective gel layers protected by removable protective sheets; The body is endowed with a central hole, from which a front small tube projects outwards, whose free end extends outwardly on an external flange, said small tube being pierced by a pin constituting the power button of the equipment, electrically interconnected to the electrical circuit board, said small tube and flange constituting the means for engaging the electrostimulation set on the support; said support is configured by a lying U-shaped rod, the arched central portion of which coincides with the user's forehead, and whose lateral portions, flanking his/her temples, extend backwards in end portions resting on his/her ears; Duly fitted to the free ends of said end portions of the rod, there are stylized C-shaped adjustment pieces; said rod having a medial longitudinal groove, wherein said groove configures the rail with which the electrostimulation set is engaged, and along which said set is moved; the following internal components are further provided: power source module, step-up regulator module, micro controller module, power supply seal module, boost source module, H-bridge module, and electrode output module.

16. The portable electrostimulation equipment for headache control using said protocol, according to claim 15, characterized in that said disposable battery is preferably a 3V one.

17. The portable electrostimulation equipment for headache control using said protocol, according to claim 15, characterized in that it comprises the electrical scheme shown in FIG. 15.

18. The portable electrostimulation equipment for headache control using said protocol, according to claim 15, characterized in that it comprises the flowchart shown in FIG. 16.

Description

DESCRIPTION OF THE DRAWING(S)

[0035] To complement the present description, to better understand the characteristics of the subject matter of the patent, a set of drawings accompanies this specification, in which, in an exemplified and non-limiting manner, the following has been represented:

[0036] FIG. 1 is a graphical representation showing the usual strategy for avoiding the nerve fiber accommodation used in the known electrostimulation protocols, that is, the use of intensity (amplitude) variation of the electrical pulses, variation that, to this day, is done regularly over time;

[0037] FIG. 2 is another graphical representation, now illustrating the novel strategy to avoid nerve fiber accommodation, provided by this innovative electrostimulation protocol, that is, the use of a random variation of electrical pulse intensity (amplitude), during the application of pulse bursts;

[0038] FIG. 3 shows, also by means of a graphical representation, one of the embodiment of this innovative electrostimulation protocol, where pulse bursts with a determined duration and with sequentially inverted polarity are continuously applied;

[0039] FIG. 4 illustrates, similarly by means of a graphical representation, other embodiments of this innovative electrostimulation protocol, that is, the intermittent mode, according to which pulse bursts are applied with a determined duration, and with sequentially inverted polarity, although providing a time interval between said pulse bursts, with a determined duration.

[0040] FIG. 5 is another graphical representation showing the steps of this innovative electrostimulation protocol;

[0041] FIGS. 6 and 7 show, from two perspectives, this innovative portable electrostimulation equipment, which includes an electrostimulation set itself, and a head support where said electrostimulation set is installed;

[0042] FIGS. 8 and 9 show two further perspectives of the equipment, now showing its component in exploded view;

[0043] FIG. 10 is a side view of said equipment;

[0044] FIG. 11 is a top view of said equipment;

[0045] FIG. 12 is an enlarged detail of the equipment, referred to as “Det. A” in the previous figure, showing only the electrostimulation set;

[0046] FIG. 13 is a sectional view of said electrostimulation set, referred to by line I-I in FIG. 12, which shows the internal components of the electrostimulation set;

[0047] FIG. 14 is a block diagram of said equipment, showing its internal electrical components;

[0048] FIG. 15 is the electrical scheme of this innovative equipment;

[0049] Finally, FIG. 16 is a flowchart of the software, specifically developed for this innovative electrostimulation protocol.

DETAILED DESCRIPTION OF THE INVENTION

[0050] This patent of invention relates to a “PROCESS FOR ESTABLISHING AN ELECTROSTIMULATION PROTOCOL FOR HEADACHE CONTROL, AND THE RESPECTIVE PORTABLE ELECTRO STIMULATION EQUIPMENT FOR HEADACHE CONTROL USING SAID PROTOCOL”, said electrostimulation process and equipment being more specifically used to control headache resulting from migraine and secondary pain to temporomandibular joint disorders.

[0051] Initially, with references to the “PROCESS FOR ESTABILISHING AN ELECTROSTIMULATION PROTOCOL”, said process provides the development of an electrostimulation protocol in which intensity variation of the electrical pulses is performed in a random manner, respecting the lower limit of stimulation efficacy, to reduce the physiological phenomenon of nervous fiber accommodation upon receiving stimuli.

[0052] More specifically, according to the present process, the electrical pulses have a square wave shape, monopolar polarity, width (or duration) between 60 μs and 100 μs, preferably 80 μs, and a frequency between 40 Hz and 70 Hz, preferably 55 Hz, and Intensity varying randomly within a range of 10 V, preferably 5 V, as shown in attached FIG. 2.

[0053] Furthermore, the present process discloses two embodiments for this innovative electrostimulation protocol, namely, continuous mode and intermittent mode.

[0054] In the continuous mode, shown in the graphical representation of FIG. 3, burst trains lasting 500 milliseconds to 2 seconds, preferably 1 second, and with sequentially inverted polarity are continuously applied.

[0055] In the intermittent mode, shown in the graphical representation of FIG. 4, pulse bursts lasting from 1 to 4 seconds, preferably 3 seconds, and with sequentially inverted polarity are applied, however there is a time interval from 1 to 4 seconds, preferably 3 seconds, between the pulse bursts.

[0056] Due to this random variation of electrical pulse intensity throughout the stimulation cycle, the novel electrostimulation protocol for the control of headache comprises the following steps, as shown in attached FIG. 5: [0057] a) intensity ramp from 0V to 25V peak (with 500Ω charge), for 2 seconds; [0058] b) 1st continuous mode period, maintained for 5 minutes; [0059] c) 1st intermittent mode period, maintained for 2 minutes; [0060] d) 2nd continuous mode period, maintained for 5 minutes; [0061] e) 2nd intermittent mode period, maintained for 2 minutes; [0062] f) 3rd continuous mode period, maintained for 5 minutes; [0063] g) 3rd intermittent mode period, maintained for 2 minutes; [0064] h) end of the protocol, after 21 minutes and 2 seconds.

[0065] In optional embodiments, this innovative protocol discloses the simultaneous use of other strategies used together with the random intensity pulse variation, as a complementary way to further avoid nerve fiber accommodation, and to make current consumption even smaller.

[0066] Among the strategies simultaneously employed with the aleatory (or random) variation of the pulse intensity, let us cite the following ones: [0067] use of monopolar pulse bursts, which allow saving battery charge; [0068] polarity inversion of the pulse bursts, avoiding muscular fiber accommodation effect; [0069] inclusion of intermittent modes of interleaved stimulation for the maintenance of analgesia, once the desired effect has been achieved.

[0070] By means of this new protocol, in which the intensity of the electric pulses has begun to vary in a random way, it was possible to efficiently reduce nerve fiber accommodation, increasing the effectiveness of the electrostimulation and, thus, of the analgesic effect.

[0071] Concurrently, this random variation of electric pulse intensity has further allowed a substantial reduction in current consumption in the operations of the electrostimulation equipment, allowing the use of standard coin-shaped lithium ion batteries, model CR20XX, which are smaller, cheaper and of lower load capacity, but sufficient to meet the current lower current consumption due to random intensity variations, incorporated by this innovative electric stimulation protocol, without the need to replace them.

[0072] Thus, it is now possible to use such common ion-lithium batteries, substantially reducing the sizes of the electrostimulation set integrating the equipment, which were greater because of the need of higher capacity batteries to provide the electrostimulation operation of the apparatus.

[0073] Regarding this “PORTABLE ELECTROSTIMULATION EQUIPMENT FOR HEADACHE CONTROL USING SAID PROTOCOL”, said equipment has the details shown in attached FIGS. 6-12.

[0074] Such equipment comprises two parts, an electrostimulation set (1) itself, and a support (2) in which said electrostimulation set (1) is installed, said support (2) configuring the element through which the electrostimulation set (1) is properly positioned and maintained in contact with the regions of the user's head, more specifically with the supraorbital and temporal regions of the user's head.

[0075] The electro-stimulator set (1) consists of a cylindrical compartment (3), formed by a front body (3a) and a rear cover (3b), which are engageable with each other, said compartment (3) housing the electronic module of the apparatus, which consists of an electrical circuit board (4) with the components and electrical circuit of the equipment; said compartment (3) also houses the power supply battery (5), which, thanks to the innovative electrostimulation protocol described before, could now be a disposable coin-shaped lithium-ion battery, model CR20XX.

[0076] On the outer back face of the cover (3b) of the compartment (3), there are two recesses (6a), which house the respective electrodes (6), suitably covered by the respective gel layers protected by removable protective sheets (7).

[0077] The body (3a) comprising said compartment (3) has a central hole (8), from which a short front small tube (9) protrudes outwardly, whose free end extends outwardly on an external flange (10), said small tube (9) being pierced by a pin (11) constituting the power button of the equipment (see more specifically the enlarged detail and the section of FIGS. 12 and 13).

[0078] Said pin (11) is electrically interconnected to the electric circuit board (4), which is internal to the compartment (3), constituting a touch actuating device whose pressing initiates a sequence of automated electrostimulations, following this innovative electrostimulation protocol, previously described, after which the equipment is automatically switched off.

[0079] In turn, the small tube (9) and the flange (10) constitute the means through which the electrostimulation set (1) is fitted to the other piece that integrates this innovative equipment, namely the support (2), described below.

[0080] Said support (2) is configured by a lying U-shaped rod (12) whose central portion (12a)—coincident with the user's forehead—becomes arched, when the user places it on his/her head, while its side portions (12b), flanking the temples, extend rearwardly into end portions (12c), which rest on the user's ears.

[0081] Properly engaged in the free ends of said end portions (12c) of the rod (12), there are two stylized C-shaped pieces (13), which constitute means for adjusting the support (2) to the head of each user, since said pieces (13) are slidable along said portions (12c) of the rod (12), from back to front, until their arched face anatomically touches the back of the user's ears, ensuring the maintenance of the support on the head, and causing the electrodes (7) to be firmly pressed against the user's skin.

[0082] Said rod (12) is further provided with a medial longitudinal groove (14) extending through the entire central portion (12a) and through the side portions (12b) thereof. Said groove (14) configures a rail in which the electrostimulation set (1) is engaged, and along which said set (1) can be moved, as explained below.

[0083] To engage the electrostimulation set (1) to the support (2), it is sufficient for the user to force the passage of the flange (10) and the small tube (9) of the former through the medial longitudinal groove (14) of the latter, from the inside out, wherein said flange (10) is disposed on the outer side of the rod (12), while the compartment (3) is disposed on the inner side thereof, with the electrodes (7) facing the user's forehead.

[0084] Once this is done, the user makes the electrostimulation set (1) slide along the groove (14), until it reaches a position chosen by him/her or determined by a medical care professional.

[0085] Once the position of the electrostimulation set (1) is selected, the user removes the protective sheets (8) which protected the gel layer from the electrodes (7), places the support (2) on his/her head, and adjusts the position of the back pieces (13) by moving them from backwards to forwards along the end portions (12c) of the rod (12), until they lie against the back of their ears; The equipment is thus securely fastened to the head, and the electrodes (6) are firmly pressed against the user's skin.

[0086] Thus, to initiate the electrostimulation session, the user presses the power button (11), which starts the sequence of automated stimulation, following this innovative stimulation protocol, previously described, after which the equipment is automatically switched off.

[0087] Since the electrostimulation set (1) is slidable along the groove (14) of the support (2), the user can change the position thereof, and then initiate a new electrostimulation session by pressing again the power button (11), which allows the application of electrical pulses in other regions of the user's face, alternating them more particularly between the supraorbital and temporal regions of his/her head.

[0088] Due to the substantially reduced sizes of the battery (5) which could now be used in the equipment in question (a coin-shaped lithium-ion rechargeable battery, model CR20XX), as well as to its substantially lower cost, electrostimulation (1) is fully disposable. Hence, said electrostimulation set (1) is used during the duration of the battery charge (5), after which it is removed from the support (2) and replaced by another set (1), which is easily engaged with the support (2), as already described above.

[0089] As mentioned earlier, when the power button (11) is pressed, the above-described electrostimulation protocol is started again, automatically switching off the device at the end of said protocol.

[0090] The block diagram of FIG. 14 illustrates the internal components of the electronic module of this innovative equipment, namely: Power source module (15), step-up regulator module (16), micro controller module (17), power supply seal module (18), boost source module (19), H-bridge module (20), and electrode output module (21). These components will be explained in details below, together with the description of this innovative electrical equipment, shown in attached FIG. 15.

[0091] As verified in said FIG. 15, the circuit (22), which refers to the Power Supply Module (15), supplies all the other circuits with the voltage supplied by the battery. When MOSFET “Q2” is saturated with the signal coming from the power bottom, it will saturate MOSFET “Q4”, energizing the circuit (24), which refers to the Step-up Regulator Module (16).

[0092] Circuit (24) has a “Q6” Step-Up Regulator Module, which acquires the voltage of the battery and raises it to 3.3 V. This output voltage is filtered by the capacitor “C6”, and then supplied to the circuit (26) and to power the microcontroller.

[0093] In the circuit (23), which refers to the Microcontroller Module (17), there is microcontroller “U1”, which is responsible for controlling all functions of the equipment. Once it has been powered, the “D3” LED flashes in an intermittent manner to indicate the operation of the equipment. Furthermore, the microcontroller then monitors the power button signal, sends the PWM signal to “Q1”, sends the signals to control the H-Bridge and also sends a signal to “Q3” in the circuit (25), which refers to the Power Seal Module (18), responsible for keeping the MOSFET “Q4” of the circuit (22) saturated, which makes it unnecessary for the Power button to be pressed to allow the equipment to remain energized.

[0094] Circuit (26) which refers to Boost Source Module (19) is a boost-type DC/DC converter whose function is to raise the 3.3V voltage range to the level that will be used in electrostimulation. The converter is controlled by a PWM signal applied to the MOSFET “Q1”, and the output voltage is sent to the circuit (27) through the capacitor “C1”.

[0095] Circuit (27), which refers to an H-Bridge Module (20), has the function of discharging in the electrodes the energy stored in the capacitor “C1” of the boost source. Another feature is to reverse the polarity of current flowing through these electrodes, said inversion occurring according to the digital signals emitted by the microcontroller. The width of the pulses outcoming from the H-bridge is also controlled by the same signal which controls polarity reversal, and then, finally, these stimuli are conducted to the user through the electrodes represented by the block (28) in FIG. 15, which refers to the Electrode Output Module (21) in the block diagram of FIG. 14.

[0096] FIG. 16 is a flowchart of the software specifically developed for this innovative electrostimulation protocol for this innovative headache control electrostimulation protocol.

[0097] As previously mentioned, not only does the new protocol of electrostimulation created by the Inventor(s) effectively reduce nerve fiber accommodation, but it makes also possible to reduce current consumption in the operations of the electrostimulation equipment, allowing the use of a disposable coin-shaped lithium-ion battery (5), model CR20XX, with smaller sizes, low cost and lower charge capacity, but sufficient to meet the current lower current consumption thanks to the random intensity variations determined by the innovative electric stimulation protocol.

[0098] Hence, it has become possible to develop the innovative electric stimulation equipment, whose electrostimulation set (1) is small, cheap, disposable and portable, making it possible for users to use it at any time and in any place, at home or at work.

[0099] Furthermore, thanks to the arrangement of the novel support (2), which also integrates this innovative equipment, the performed electrostimulation sessions have been carried out in a safer and more efficient manner, and in various regions of the user's face, more particularly between the supraorbital and temporal regions of his/her head, providing even more comfort to the user.