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

Abstract

Electrostimulation processes and equipment used in the control of pelvic pain of different etiologies, particularly, pain resulting from dysmenorrhea and endometriosis, the process predicting the development of an electrostimulation protocol wherein variation of the intensity of the electric pulses is performed in a random manner to reduce the physiological phenomenon of nerve fiber accommodation upon stimuli. A portable electrostimulation device includes a double bandage formed by two sheets, each including a central portion and two side flaps, a compartment between the central portions housing the electronic module of the apparatus, the side flaps of the top sheet housing the respective electrodes having respective gel layers protected by removable protective sheets which include respective fastening strips. A coin-shaped lithium-ion supply battery, a single on-off button, and the following internal components are provided: power source, step-up regulator, micro controller, power supply seal, boost source, H-bridge, and electrode output modules.

Claims

1. A process for establishing an electrostimulation protocol for pelvic pain 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, monopolar polarity, 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 0 V to 25 V peak [measured with resistive charge of 500Ω], for 5 seconds; b) 1st period of continuous mode, maintained for 5 minutes; c) 1st period of intermittent mode, maintained for 2 minutes; d) 2nd period of continuous mode, maintained for 5 minutes; e) 2nd period of intermittent mode, maintained for 2 minutes; f) 3rd period of continuous mode, maintained for 5 minutes; g) 3rd period of intermittent mode, maintained for 2 minutes; h) end of the protocol, after 21 minutes and 5 seconds.

2. The process for establishing an electrostimulation protocol for pelvic pain 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 pelvic pain 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 pelvic pain 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 pelvic pain 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 pelvic pain 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 pelvic pain 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 pelvic pain 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, wherein said interval lasts 1-4 seconds.

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

15. Portable electrostimulation equipment for pelvic pain control using said protocol, characterized in that it consists of a double bandage of two sheets, each comprising a central portion and two lateral flaps, the central portion of both sheets housing between them a compartment formed by a body and a cover, which configures a housing for the electronic module of the apparatus, and the two side flaps of the top sheet housing the respective electrodes, duly covered by the respective gel layers, protected by removable protective sheets; each one of the sheets is additionally endowed with a respective fastening strip; the electronic module consists of a printed circuit board with the electrical components and circuit of the apparatus, a disposable coin-shaped lithium-ion supply battery, model CR20XX and a single connecting button, whose activation initiates the electrical stimulation protocol, at the end of which the apparatus is automatically switched off, are provided; 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, electrode output module.

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

Description

DESCRIPTION OF THE DRAWINGS

[0042] 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:

[0043] 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;

[0044] 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;

[0045] 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;

[0046] 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.

[0047] FIG. 5 is another graphical representation showing the steps of this innovative electrostimulation protocol;

[0048] FIGS. 6 and 7 show this innovative portable electrostimulation equipment for pelvic pain control, respectively by bottom and top perspectives;

[0049] FIGS. 8 and 9 show the same perspectives illustrated in FIGS. 5 and 6, now showing their components in exploded view;

[0050] FIG. 10 is a bottom view of said equipment;

[0051] FIG. 11 is a top view of said equipment;

[0052] FIG. 12 is a section of the equipment, indicated by line A-A in FIG. 11, wherein FIG. 12A is an enlarged detail thereof, indicated in the previous figure;

[0053] FIG. 13 is another section of the equipment, indicated by line B-B in FIG. 11, wherein FIG. 13A, is an enlarged detail thereof, indicated in the previous figure;

[0054] FIG. 14 is a block diagram of said equipment;

[0055] FIG. 15 is the electric scheme of this innovative equipment;

[0056] Finally, FIG. 16 is a flowchart of the software, specifically developed for this innovative electrostimulation protocol.

DETAILED DESCRIPTION OF THE INVENTION

[0057] The present patent relates to a “PROCESS FOR ESTABLISHING AN ELECTROSTIMULATION PROTOCOL FOR PELVIC PAIN CONTROL, AND THE RESPECTIVE PORTABLE ELECTROSTIMULATION EQUIPMENT FOR PELVIC PAIN CONTROL USING SAID PROTOCOL”, said electrochemical process and equipment being more specifically used for controlling the pain deriving from dysmenorrhea, endometriosis and other painful conditions of women's pelvic cavity.

[0058] With references to the “PROCESS FOR ESTABLISHING 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 limits of stimulation efficacy, to reduce the physiological phenomenon of nervous fiber accommodation upon receiving stimuli.

[0059] More specifically, according to the present process, the electrical pulses have a square wave shape, are monopolar, have a width (or duration) between 60 μis 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.

[0060] Furthermore, the present process discloses two embodiments for this innovative electrostimulation protocol, namely, continuous mode and intermittent mode.

[0061] 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.

[0062] 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.

[0063] Due to this random variation of electrical pulse intensity throughout the stimulation cycle, the novel electrostimulation protocol for the control of pelvic pain presents the following steps, as shown in attached FIG. 5: [0064] a) intensity ramp from 0 V to 25 V peak [measured with resistive charge of 500Ω], for 5 seconds; [0065] b) 1st period of continuous mode, maintained for 5 minutes; [0066] c) 1st period of intermittent mode, maintained for 2 minutes; [0067] d) 2nd period of continuous mode, maintained for 5 minutes; [0068] e) 2nd period of intermittent mode, maintained for 2 minutes; [0069] f) 3rd period of continuous mode, maintained for 5 minutes; [0070] g) 3rd period of intermittent mode, maintained for 2 minutes; [0071] h) end of the protocol, after 21 minutes and 5 seconds.

[0072] 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.

[0073] Among the strategies simultaneously employed with the aleatory (or random) variation of the pulse intensity, let us cite the following ones: [0074] use of monopolar pulse bursts, which allow saving battery charge; [0075] polarity inversion of the pulse bursts, avoiding muscular fiber accommodation effect; [0076] inclusion of intermittent modes of interleaved stimulation for the maintenance of analgesia, once the desired effect has been achieved.

[0077] 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.

[0078] Concurrently, this random variation of electric pulse intensity 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, determined by this innovative electric stimulation protocol, without the need to replace them.

[0079] Thus, it is now possible to use such common ion-lithium batteries, substantially reducing the dimensions of the equipment, which were greater because of the need of higher capacity batteries to provide electrostimulation operations of the apparatus.

[0080] Regarding this “PORTABLE ELECTROSTIMULATION EQUIPMENT FOR PELVIC PAIN CONTROL USING SAID PROTOCOL, said equipment is shown in details in attached FIGS. 6 and 13.

[0081] Such equipment is constituted by a double bandage (1) formed by two sheets (2), each comprised of a central portion (2a) and two side flaps (2b), the central portion (2a) of both sheets (2) housing between them a compartment (3) formed by a body (3a) and a cover (3b), which forms a housing for the electronic module of the apparatus and the two side flaps (2a) of the top sheet (2) housing the respective electrodes (4), duly covered by the respective layers of gel protected by the removable protective sheets (5); each of the sheets (2) is additionally endowed with a respective fixing strip (6), which joins the sheets to the electronics compartment of the equipment.

[0082] As already mentioned, the central compartment (3) houses the electronic module of the apparatus, consisting of a printed circuit board (7) with the electrical components and circuit of the apparatus; said central compartment (3) also houses the power supply battery (8), which, thanks to the innovative electrostimulation protocol hereinbefore provided, could now be a rechargeable coin-shaped ion-lithium battery, model CR20XX.

[0083] This innovative equipment discloses a single on-off button (9), which, upon actuation, starts the above-described electrostimulation protocol, automatically switching off the device, at the end of said protocol.

[0084] The block diagram of FIG. 14 illustrates the internal components of the electronic module of this innovative equipment, namely: Power source module (10), step-up regulator module (11), micro controller module (12), power supply seal module (13), boost source module (14), H-bridge module (15), and electrode output module (16).

[0085] These modules will be explained in details below, together with the description of this innovative electrical equipment, shown in attached FIG. 15.

[0086] As verified in said FIG. 15, circuit (17), which refers to the Power Supply Module (10), 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 (19), which refers to the Step-up Regulator Module (11).

[0087] Circuit (19) 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 (21) and to power the microcontroller.

[0088] In the circuit (18), which refers to the Microcontroller Module (12), there is microcontroller “UI”, which is responsible for controlling all functions of the equipment. Once it has been powered, the “D3” LED flashes in an intermittent mode 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 sends a signal to “Q3” in the circuit (20), which refers to the Power Seal Module (13), responsible for keeping the MOSFET “Q4” of the circuit (17) saturated, which makes it unnecessary for the Power button to be pressed to allow the equipment to remain energized.

[0089] Circuit (21), which refers to Boost Source Module (14), is a boost-type DC/DC converter whose function is to raise the voltage range of 3.3 V 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 (22) through the capacitor “C1”.

[0090] Circuit (22), which refers to a H-Bridge Module (15), 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 (23) in FIG. 15, which refers to the Electrode Output Module (16) in the block diagram of FIG. 14.

[0091] FIG. 16 is a flowchart of the software specifically developed for this innovative electrostimulation protocol for this now innovative pelvic control electrostimulation protocol.

[0092] 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 (8), 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.

[0093] Hence, it has become possible to develop the innovative electric stimulation equipment, which is disposable, cheap, compact and portable, making it possible for users to use it at any time and in any place, at home or at work.

[0094] Moreover, thanks to the alterations introduced by the Filing Applicant in the electronics and mechanics of the equipment, it was possible to make it a one-touch actuating device, which substantially facilitated its use by users, who no longer need to use control bottoms to regulate the intensity of the electric pulses.

[0095] In fact, in this innovative equipment, the operation is carried out through a single on-off button (9), whose activation initiates the automated electrostimulation sequence, following this innovative electrostimulation protocol, after which the equipment is automatically switched off. Hence, not only does it facilitate the use of the apparatus, but it also avoid, in a totally safe manner, the occurrence of errors resulting from the user's incorrect control of the control buttons.