RO137883A0 - Device for reducing pain sensations by trans-dermal electrostimulation with micro-currents - Google Patents

Abstract

The invention relates to a device for reducing pain sensations, meant to be used for various therapies in the medical field. According to the invention, the device comprises an electric energy supply module, which supplies, through electrical cables, a generator of low voltage bipolar alternating signal, which is connected to a control module and to two electrodes placed onto a patient's body, where the signal generator is configured to generate biostimulating electrical signals, which are bipolar with a rectangular wave form and have a symmetrical filling factor, and the control module is configured to run a program selected from a list of programs, consisting of a sequence of steps of electrical stimulation of the tissues and/or nerves, each characterized by time of running, frequency of the stimulating signal and intensity of the electric current.

Description

RO 137883 AO

STATE OFFICE FOR INVENTIONS AND TRADEMARKS

DEVICE FOR REDUCING PAIN SENSATIONS THROUGH TRANS TEGUMENTAL ELECTRO-STIMULATION WITH MICRO

CURRENT

The field of the invention is that of trans tegumental electrostimulation of nerves and tissues of living organisms by means of micro currents.

As is known, in cell biology electric current influences the functioning of cells and their interaction electrochemically.

From the state of the art, numerous methods of electrostimulation and therapy are known that can be classified according to the biological interactions produced by the electric current, if they are fully known, or preferably according to the characteristics of the electric currents used and the manner of their application.

Unlike indirect stimulation methods such as radiotherapy or phototherapy, direct electrostimulation methods involve the injection of electric currents through electrodes placed internally, as is the case with cardiac pacemakers, or externally, at the skin level, in precisely located stimulation points. The injected electric current produces electrochemical effects that influence microbiological processes, which may persist for a period of time even after its disappearance.

Several methods of direct electrostimulation are well known such as:

• Electrophoresis, a method by which particles suspended in a liquid or gel and which have or are covered by film electric charges, under the action of the electric current they contain, are ionically displaced. For example, the selective modulation of the permeability of cell membranes is known [1] and

RO 137883 AO influencing the electrochemical gradients between the inside and outside of cells [2] under the action of direct current and/or ionic currents. It is also known to use electrophoresis as a method to stimulate cellular uptake or intercellular concentration of ionized drug molecules [3].

• D'Arsonval procedures are methods of stimulation by bipolar currents of high frequency and relatively high intensity that cause a diathermy effect and which are used, for example, to treat the skin.

• Electroacupuncture in direct current through possibly pulsed micro current is another procedure known for the treatment of neurological conditions.

• Electro-convulsive therapy ECT through high pulsed currents of the order of hundreds of milliamperes and high voltage of the order of a hundred volts is also known and applied for example as a method of treatment on the central nervous system.

• EMS muscle electrostimulation, a method of electrostimulation of muscles by means of short, high-voltage electrical impulses and which are mainly used for training and developing muscle strength.

• NMES therapy, a method of electrostimulation of the muscles through pulsed currents in the order of ImA and which are between the threshold of sensory activation and that of motor activation and which have a duration of the order of hundreds of microseconds, the pulses being applied with a frequency between 1 -10000 Hz, NMES therapy being mainly used to strengthen muscle power.

• TENS therapy, a method of trans-tegumentary electrostimulation of the nerves through low bipolar currents of the order of milliamperes and with frequencies between 10Hz and 1OKhz and which is applied as a treatment procedure to reduce pain.

RO 137883 AO qh • MENS therapy, a method of electrical stimulation through micro currents of the tissues and in particular of the smooth muscle fibers in the walls of the lymphatic or blood vessels and which are used in pain therapy and the treatment of inflammation.

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Among the mentioned methods, TENS and MENS therapies use relatively small bipolar currents that have the advantage of being similar and comparable in intensity, potential and parameters to biological currents produced by nerves (i.e. the resting potential being -70mV) and to ionic interactions at the level cells that, due to their oscillating nature, have the advantage of not producing ionic imbalances and charge accumulations, being non-destructive.

From the state of the art, it is known that the frequency of electrostimulation produces different effects on tissues, nerves and organs.

Also from the state of the art, it is known that the epidermis and the tissues have a different impedance [4] depending on the electrostimulation frequency and the penetration depth and propagation paths depend on the frequency of the electrostimulation current.

From the state of the art, it is known that the natural potential of the neuronal membrane is approximately -70 mV and the use of artificial electrostimulation currents that create potentials close to this threshold is appropriate because it is similar to the natural processes of neuronal stimulation and does not generate additional inflammatory degenerative electrochemical effects at the level of neurons and other tissues being thus adapted for pain therapy without increasing inflammation.

Also from the state of the art, it is known that direct current or even bipolar currents in pulses that are not balanced as load transport are not preferable due to this imbalance, i.e. of the continuous component.

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From the state of the art, it is known that, among metals, copper is an electropositive metal abundant in nature, a good conductor, which can have a deficit of up to two electrons on the valence layer and which through oxidation has disinfectant properties [5], anti microbes [6] being thus suitable for the construction of electrodes in electrostimulation methods.

The invention TW201444599A is known which presents a localized transdermal microcurrent stimulation device comprising: a microcurrent exit point to be adhered to a point on the human skin; and a plurality of microcurrent input points distributedly adhered to a skin area, characterized in that the microcurrent output point is provided with a microcurrent control circuit and a microcurrent power element, and a unidirectional divergent circuit connected with microcurrent entry points; the microcurrent input points receive microcurrent and perform localized multidirectional converging conduction through the human skin and other subcutaneous tissues, so as to introduce microcurrent into the microcurrent output point, thus forming a planar complete loop.

US2022347477A1 discloses a system and method for applying stimulation therapy to a patient, the system including a first stimulation strip including a first elongated portion configured to be placed on the upper eyelid of the patient's first eye and a second portion elongated device configured to be placed on the lower eyelid of the patient's first eye, wherein the first stimulation strip includes: a first plurality of individually controlled electrodes configured to provide microcurrent stimulation therapy to the patient, a first plurality of controlled light emitters individually configured to provide light stimulation therapy to the patient and a first plurality of individually controlled heat sources configured to

RO 137883 AO provided thermal therapy to the patient; and a controller operatively coupled to the first stimulation strip and configured to control the administration of microcurrent stimulation therapy, light stimulation therapy, and heat therapy

US9333346B1 discloses a microcurrent stimulation device with a power source, two or more electrodes electronically coupled to the power source, a microcontroller configured to generate an electromagnetic waveform, an impedance measurement module configured to to measure the electrical impedance of one or more biological tissues between the two or more electrodes. A first safety circuit monitors the flow of electrical current through one or more components of the microcurrent stimulation device and interrupts the flow of electrical current if the flow of electrical current through the one or more components is above a predetermined level. A second safety circuit interrupts the flow of electrical current through one or more components if a firmware failure occurs.

The technical problem of the invention is the creation of a device for reducing pain sensations through electrostimulation which:

• be adapted to personal use:

• not to produce additional inflammation or adverse effects • to allow the reduction of pain by electrostimulation without knowing or precisely diagnosing its cause • to be adapted to the stimulation of different parts of the human body (i.e. peripheral nerves and/or the central nervous system, inflamed tissues, lymphatic vessels or blood, organs, etc.) and that have specific access routes and stimulation parameters.

• not require precise positioning of the electrodes

RO 137883 AO her • not to require the permanent presence of a specialist during stimulation

The system according to the invention overcomes the above disadvantages in that it is a system for treating pain by electrostimulating the tissues and nervous system of a human subject, and comprising:

• a power supply module and, • a low voltage bipolar alternating signal generator and, • a signal generator control module and, • a pair of electrically conductive flexible cables connected to the signal generator and, • two electrodes each connected by the two leads to the signal generator and placed on the body of the human subject at recommended treatment points

The signal generator is powered from the power module and configured to generate electrical biostimulation signals that:

• are square-wave bipolar and, • have a symmetrical fill factor, and, • the peak-to-peak voltage is below the 50 volt limit, and, • the generated current, when the generator is operating and skin-contact coupled to the human subject using the wires and electrodes, has a constant value controlled by the control module and which has ί value in the range [10, 500] micro Amperes and,

The control module of the generator is configured to execute a program that can be chosen from a list of programs, the program consisting of a

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4(0 sequence of phases of electrical stimulation of tissues and/or nerves, each stimulation phase being characterized by:

• a duration of execution with values in the range [3, 3700] seconds and, • a frequency of the stimulation signal with values in the range [10, 10000] Hertz and, • an intensity of the electric current that can be chosen for each phase by program or user and which is kept constant by the signal generator regardless of the impedance of the biological tissues between the two electrodes and,

The electrodes are identical in shape, weight and contact surface and are made of solid copper of high purity over 95%.

The device according to the invention has the following advantages:

- effective in reducing the sensation of pain,

- the possibility of a simple personal use without the need for precise positioning of the electrodes and without the need for the presence of a specialist,

- does not produce adverse effects.

Other advantages are presented and will become apparent from the detailed description of the invention.

An example of the realization of the invention is given next in relation to the figures which represent:

Figure 1 shows the block diagram of the device for the reduction of pain sensation by trans-cutaneous electrostimulation with microcurrents.

Figure 2 illustrates a top view of the device box

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Figure 3 illustrates in a flowchart the steps of the electrostimulation procedure performed by the central unit of Figure 1.

It goes without saying that the drawings and detailed description that follows are given as preferred examples, they limit the spirit of the invention and should be interpreted broadly. It is also apparent that, to a person trained in the field of TENS or MENS electrostimulation systems, other examples and variants of alternative implementations are obvious and readily identifiable and extrapolated within the spirit of the invention.

According to a first aspect of the invention, the power module and signal generator are configured to produce a fill-factor symmetrical rectangular bipolar current with no DC component and which does not generate permanent unidirectional transport of ions or electrical charges through tissues.

According to one aspect of the invention, the current is reduced with the maximum value below one milliampere, it is comparable in order of magnitude to the natural currents produced by nerves or to those existing at the level of cell membranes and is below the limit of perceptible sensitivity producing us an additional inflammatory stress .

According to a major aspect of the invention, the control module is configured to execute at the user's choice a program from a list of electrostimulation programs, the program being made up of several successive phases each characterized by a stimulation period, a frequency and current intensity that is adequate to stimulate a part of the human body.

According to one aspect of this invention, a program executed by the central unit is in accordance with the principles of holistic medicine in which the human being is acted upon as a whole, with all his component systems in more

RO 137883 AO

8« many phases of stimulation, each phase being configured to address a certain aspect associated with pain:

• cleansing the body of toxins, which also has the effect of regulating the PH of the body (it is medically known that an acidic PH often leads to joint pain), • pain in the internal organs, • pain coming from the soft tissues, • pain of the bone system, the skeleton, • activation of the brain, to send messages to stimulate the healing process, • activation of the brain, to reevaluate the state of pain, as sometimes the brain remains stuck in a positive reaction loop and exacerbates the state of pain (it is it is known that pain has physical and psychological causes, the intensity of pain being subjective) • stimulation of lymphatic circulation, it being known that lymphatic drainage reduces swelling, reduces pain and improves body mobility in accordance with one aspect of this invention, although the cause of pain is not necessarily known or the pain radiates for example in some conditions such as sciatic nerve pain and in which the injury and the pain have different locations, however by performing several phases that are part of a known list of possible causes and which are treated in different phases it is possible to reduce the feeling of pain even in the absence of a clear diagnosis.

According to one aspect of this invention, the reusable electrodes are of high purity polished copper being easy to clean, the surface being

RO 137883 AO antibacterial and which are easily sterilized and have a large surface preferably around 50 square cm and which has two effects:

• allows even an imprecise placement in the recommended area and, • the electrostimulation current is spread with no concentration points, so it is a matter of a uniform injection or extraction of the charge over a large surface.

In accordance with an important aspect of this invention, the thickness of the electrodes is correlated with the depth of penetration of the film into the metal of the electric current and which for copper and for the electrostimulation frequency of 5228 Hz is 3 mm of waves and the recommended thickness of the electrodes which is double of this value and which is limited for practical reasons to 6mm so that the entire charge in the electrode is mobilized and injected or extracted from a large surface.

In accordance with one aspect of this invention, the current is held constant by the signal generator through a feedback loop, the central unit modifying the parameters of the generator so that the target current is held constant, the user being able to percentage select its value according to the subject human and/or pain condition, it being known that for children or for subjects with wet skins the current is preferably lower.

According to an aspect of this invention, the central unit is configured so that for the phases of stimulation of the lymphatic circulation the value of the electrostimulation current is close in value to the value of the electrostimulation of the smooth muscles in the walls of the lymphatic tissues and which is around 70uA.

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In accordance with one aspect of this invention, the signal generator is configured to produce stable frequencies with a higher quality factor correlated with that of a reference clock and which, for an oscillator with a reference whose frequency is temperature compensated and using a 16 MHz quartz crystal is 20 parts per million divided by the ratio of the electrostimulation frequency to the quartz oscillation frequency, which is extremely stable. It is known from holistic medicine that the value and stability of the electrostimulation frequency has an important effect on the results of the electrostimulation.

In accordance with one aspect of this invention, a complete standard electrostimulation program has the following phases:

• a phase of cleansing the body of toxins" uses the frequency of 727 Hz for 180 sec followed by, • a phase of regulating the Ph" uses the frequency of 811 Hz for 60 sec followed by, • a phase for reducing pain due internal organs" uses the frequency of 1021 Hz for 720 sec adjustable up to 1800 sec followed by, • a phase to reduce pain due to inflammation of soft tissues and muscles" uses the frequency of 525 Hz for 900 sec adjustable up to 3660 sec followed by , • an identical first phase for the release of blocked negative charges and interruption of the positive pain reaction loop of the nervous system" which uses the frequency of 1064 Hz for 3 sec and which is followed by, • a phase for mobilizing the liver, so that to eliminate toxins more effectively" uses a frequency of 44 Hz for 600 sec and which is followed by,

RO 137883 AO • a phase to reduce pain in the genital area and sacrum uses a frequency of 65 Hz for 180 sec followed by, • a phase to release blocked negative charges and break the positive reaction loop to pain in the nervous system" 156Hz for 60s that can be repeated in conjunction with the different phases of the electrostimulation program or, • a second phase for the release of blocked negative charges and interruption of the positive pain reaction loop of the nervous system" which uses the frequency of 1064 Hz for 3 sec and which is followed by, • a phase for reducing osteo-skeletal pain" uses a frequency of 5228 Hz for 240 seconds up to 2880 sec and which is followed by, • a phase to stimulate lymphatic circulation" uses a frequency of 936.8 and

Hz for 420 sec.

In accordance with one aspect of this invention, the schedule, schedule period or phases, electrostimulation current are configurable and enable electrostimulation for a wide range of pain conditions.

According to one aspect of this invention, the human-machine communication method is by means of buttons and an LCD display, but not limited to this, various other methods being possible, for example the use of NFC, bluetooth or Wifi interfaces, commanded by a mobile phone or tablet.

According to one aspect of this invention, the power source can be battery-powered and according to medical electronics rules and regulations, during charging, the signal generator is automatically disconnected from the electrodes by a relay to avoid a potential electrocution accident.

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In accordance with one aspect of this invention, the signal generator and power circuit also have over-voltage, short-circuit or over-heat protection.

In accordance with one aspect of this invention, the central unit may be configured to suspend a program or phase of electrostimulation for a pause period, but for maximum treatment efficiency, continuous, uninterrupted execution of the program or phases is recommended.

According to one aspect of this invention, the device can be used only after a doctor verifies the potential contraindications, excluding its use in certain cases such as subjects who have a cardiovascular pacemaker.

In accordance with one aspect of this invention, the central unit may be configured to suspend a schedule or phase of electrostimulation for a pause period.

The present invention is illustrated and described below. The same alphanumeric references are used to identify the same item in the various illustrations. References with the same numeric prefix followed by a character are variants of the same entity.

9

The device for reducing the sensation of pain through transtegumental electrostimulation with microcurrents according to the invention in preferred implementation variants has the composition and operation shown below with reference to the explanatory figures.

Figure 1 illustrates according to a preferred implementation, the component parts of the device for reducing the sensation of pain by means of transintegumentary electrostimulation with microcurrents (100) and which contains consists of a box (101) on which are placed a number of electrical connectors (104a-b ) and (105) which do

RO 137883 AO the connection between the internal parts of the device (100) and which are located inside the box (101) and the external parts, a switch (108), an LCD display (113) and a number of control buttons (112).

According to the preferred implementation illustrated in figure 1, the device can be powered by a power cable connected to the power terminal (105) which is at least 2 pins and preferably also a 3rd ground pin connected to the box ( 100) if it has metallic parts, the power cable being preferably connected to the local alternating current electrical network or to a direct current voltage source and for example a 5 volt or 12V USB power supply.

According to the preferred implementation illustrated in figure 1, on the box (101) there is also a double connector (104a-b) to which two solid copper electrodes (102a-b) are connected via two flexible conductive wires (103a-b) which are placed on a human subject at the cutaneous level at well-established treatment points and which when the device (100) is switched on and operating creates an electrical circuit through which the device (100) injects treatment microcurrents via the wires (103a-b) and the electrodes (102a-b).

According to the preferred implementation illustrated in figure 1, the power terminal (105) is connected to a charger (106) which transforms the input voltage present at the power terminal (105) into a voltage suitable for charging a battery (107) which is placed in the box (101) and which, when the switch (108) is positioned in a charging position, makes the connection between the charger (106) and the battery (107) which allows charging the latter when the device is supplied with electricity via the power terminal (105).

RO 137883 AO

As will be apparent to one skilled in electronics, the charger (106) preferably also has a protection circuit that monitors:

• the differential leakage of the supply current to ground and/or, • the supply current and/or voltage generated and applied to the battery (107) and/or, • the temperature of the battery (107) and/or the charger and, which limits or interrupts the supply charger (106) or battery (107) when the protection circuit is activated.

In a preferred implementation, the charger (106) is made using a Microchip MCP73833 circuit or equivalent. Other implementations are obvious, possible and within the spirit of the invention.

As is obvious to a person trained in the field of medical electronics, in order to avoid potential electrocution of users it is prohibited to operate the device when it is powered from an external power source i.e. the double connector (104a-b) must be electrically isolated and, according to the preferred implementation illustrated in figure 1, a protective relay (115) is located intermediate between a final stage (114) which produces an electrostimulation voltage and the double connector (104a-b) and which, when there is a voltage at the power terminal (105) isolates the electrical connection between the final floor (114) and the double connector (104a-b) so that the electrical circuit through the conductive wires (103a-b) is null.

In a possible alternative implementation, the accumulator (107) is replaced by a user replaceable battery. if the battery

RO 137883 AO (107) is replaced by a battery, the charger (106) and the relay (115) are neither needed nor present and the switch (108) has only two positions by which it powers or not other parts of the device (100).

According to the preferred implementation illustrated in figures 1, the switch (108) is physically operable by the user being located on the housing (101) and has three positions:

• the off position in which the charger (106), the battery (107) and respectively other parts of the device (100) are not connected and, • the charging position in which the charger (106) is connected to the battery (107) and, • the position of operation in which the charger (106) is isolated and the battery (107) is electrically connected to other parts of the device (100) which it supplies with electricity.

According to a preferred implementation not illustrated, the switch (108) can also physically interrupt the electrical connections between the power terminal (105) and the charger (106) in which case the protection relay (115) is not present.

According to the preferred implementation illustrated in figure 1, the device (100) also contains a central unit (109) which is preferably a micro controller containing a CPU processor, a RAM memory, a flash memory, a number of GPIO pins that can be commanded or read depending on the configuration and which are linked to a number of control buttons (112), to an LCD display (113) or other type and which also has GPIO pins or digital interfaces of type PWM, I2C , SPI or DAC-type analog through which it controls a signal generator (110) and a voltage source (111).

RO 137883 AO in a preferred implementation, the central unit (109) is an ATMEL ATXMEGA128A3 microcontroller or equivalent. Other implementations are obvious, possible and within the spirit of the invention.

Preferably the central unit (109) also has an interface through which it can be programmed which, in a preferred implementation, is a UART interface circuit such as Silicon Labs CP2102 or equivalent. Other implementations are obvious, possible and within the spirit of the invention.

According to the preferred implementation illustrated in Figure 1, the buttons (112) can be operated by the user and read by the central unit (109) and allow:

• user selection of a configuration parameter and which is:

a display language and an electrostimulation program and the intensity of the electrostimulation current and the total duration of the program • changing the value of the selected parameter and • executing a command:

o starting or stopping the selected electrostimulation program using the selected and modified parameters and, o temporarily interrupting or resuming the started electrostimulation program.

According to the preferred implementation illustrated in Figure 1, the LCD display (113) displays a visual indication of the parameters selected by the user and the current state of the device (100).

In a preferred implementation, the LCD display (113) is a display of type RX12864H with a resolution of 128 / 64 pixels made by Raystar Optronics or

RO 137883 AO equivalent and which is controlled via an SPI interface by the central unit (109). Other implementations are obvious, possible and within the spirit of the invention.

Figure 2 illustrates a top view (101a) of the box (101) of the device (100) illustrated in Figure 1 and which, according to a preferred implementation, allows the LCD display (113) to be viewed and the buttons (112a-h) to be operated.

According to the preferred implementation illustrated in figure 2, the LCD display (113) displays: » • the language selected and used to display the user interface and, • the currently selected electrostimulation program, and, • the relative intensity of the electrostimulation current to a reference value, and, • the elapsed time of the treatment sequence and, • the total time or duration of the electrostimulation sequence of the selected program.

According to the preferred implementation illustrated in Figure 2, the buttons (112) of Figure 1 are:

• a start/stop control key (112a) and which by actuation starts or stops the selected electrostimulation program and, • a pause control key (112b) and which by repeated pressing temporarily stops or resumes the selected electrostimulation program allowing the user to perform another short-term task and continue

J electrostimulation after its completion and, • an increment key (112g) that allows adjusting the value of the currently selected parameter by incrementing it or choosing the next value in order from the list of parameter values and,

RO 137883 AO • a decrement key (112h) that allows adjusting the value of the currently selected parameter by decrementing or choosing previous values as order from the list of parameter values and, • a key for selecting the intensity (112c) and which, when activated, selects as current parameter that can be modified the intensity of the electrostimulation current and, • a key for selecting the electrostimulation program (112e) of the electrostimulation program and which, when actuated, selects as the current parameter the electrostimulation program and resets its duration to a predetermined initial value which can later be adjusted by the user and, • a key for selecting the electrostimulation duration (112d) of the program and which, when actuated, selects as the current parameter the duration of the electrostimulation program and, • a key for selecting the language of the user interface (112f) and which can be chosen from the list of available languages through the increment (112g) and decrement (112h) buttons.

In a preferred implementation, the buttons (112a-h) are normally open "push-button" type micro-switches which when actuated change the state of an input GPIO pin of the central unit (109). Other implementations are obvious, possible and within the spirit of the invention.

According to the preferred implementation illustrated in Figure 2, the selected parameter is prefixed by a visual selection indication "*".

Returning to Figure 1, according to the illustrated implementation, the LCD display (113) is controlled by the central unit through a display procedure.

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Equivalent and alternative ways of displaying information and reading a push-button keyboard by a microcontroller executing a human-machine interaction procedure are well known and obvious to one skilled in the electronics field.

J 5

It is also known and obvious to a person with knowledge in the field of electronics the ways of communication between a microcontroller and other devices using digital interfaces such as GPIO, SPI, I2C or others or analog-digital or digital-analog interfaces such as CAN and DAC respectively .

According to the preferred implementation illustrated in figure 1, the central unit (109) controls a voltage source (111) so that the electrostimulation current is stable and is that selected by the user regardless, for a range of values, of the impedance of the human subject that can it varies from case to case depending on the human subject and other conditions such as skin moisture and tissue composition, stimulation frequency, and electrode placement (102a-b).

in a preferred implementation, the voltage source (111) is made using a DC-DC step-up converter of the TPS61085 type and which produces a voltage limited to a maximum of 18.5 volts. Other implementations are obvious, possible and within the spirit of the invention.

According to the preferred implementation illustrated in Figure 1, the central unit (109) controls the signal generator (110) and which is precision and generates a rectangular frequency with a duty factor of 50% according to the program and the electrostimulation phase.

In a preferred implementation, the signal generator (110) is made using as a reference a programmable counter oscillator having a reference of

RO 137883 AO frequency a quartz crystal of high frequency and whose frequency ratio is controlled by the central unit (109) by means of control GPIO pins.

in a preferred implementation, the signal generator (110) is made using as a frequency reference a 16 MHz quartz crystal and two 74HC6323A circuits placed in series controlled by the central unit (109). Other implementations are obvious, possible and within the spirit of the invention.

According to the preferred implementation illustrated in figure 1, the final circuit (114) produces a rectangular differential electrostimulation signal having the frequency given by the signal generator (110) and the peak-to-peak amplitude twice the voltage produced by the voltage source (111).

in a preferred implementation, the final circuit (114) is realized by a dual MOSFET driver, each of the outputs driving an NCS2001 operational amplifier. Current through the output circuit is sensed from the voltage drop through a series resistor and a fixed-gain current op-amp of the LMP8640 type. The current detected on the two outputs is summed through two resistors and read through a CAN analog-to-digital converter by the central unit (109) which adjusts the voltage generated by the voltage source (111) so that the average of its value for a time window be equal in value to the electrostimulation current chosen by the user.

in a preferred implementation, the final circuit (114) also has diodes for overvoltage protection and the central unit (109) also detects if the impedance of the tissue is outside a range of admissible values, too high an impedance being generated by a faulty placement of electrodes or an unexpectedly high tissue impedance. Error conditions can be displayed on the LCD display or

RO 137883 AO signaled by a buzzer commanded by the central unit (109). Other implementations are obvious, possible and within the spirit of the invention.

Figure 3 illustrates by a flowchart the steps of the electrostimulation procedure (300) performed by the central unit of Figure 1, which are:

• the procedure starts in the initial state (301) which is detected by the central unit when the user presses the START/STOP button (112a) in figure 2 and which is connected to the central unit and, • in the program initialization step (302) following the state initials (301), the electrostimulation program is loaded into the RAM memory, which includes the list of electrostimulation phases and their specific parameters, which are:

a duration of the phase and, a value of the electrostimulation current and, a frequency of the electrostimulation signal and the first phase from the program phase list is chosen as the current phase and, • in the phase initialization step (303) following the program initialization step (302) the signal generator (110) in figure 1 is commanded to generate a frequency equal to the frequency of the electrostimulation signal and the voltage source (111) in figure 1 to generate a voltage of 18.5 volts and as a result the final stage produces a rectangular differential signal of maximum 37 volts peak-to-peak with the same frequency and the value of the current through the final circuit is periodically read and the value of the voltage generated by the voltage source (111) is adjusted so that the electrostimulation current has the value chosen by the user and a timer is initialized with the value of the duration of the electrostimulation phase, • in the waiting step, an interruption caused by:

RO 137883 AO o from the pause button (112b) in figure 1 and its value is memorized, the execution being continued through the pause/resume step (305) or, o from the timer when it expires and the duration of the phase has been reached and execution is continued through the next phase selection step (306) and, • in the pause/resume step (305) if:

o the state of the pause button (112b) was inactive, then the state of the current electrostimulation phase is memorized, including that of the timer, and a pause phase is loaded with the following parameters: a duration of 5 minutes, a zero stimulation current and a frequency of 0 Hz. Thus the duration of the pause cannot exceed 5 minutes after which, if the user has not pressed the pause button (112b) again to resume the electrostimulation program, it is finished or, o if the state of the pause button (112b) was active then the state of the phase of stored electrostimulation is restored by the phase initialization step (303) which receives the stored values as parameters and, • in the next phase selection step (306) it is checked if:

a current phase is the pause phase and it has expired in which case it goes to the finish step (307) a current phase is a program phase other than the last one in which the program advances to the next phase and continues through the phase initialization step ( 303) for the next phase in the list and, a current phase is the last phase of the program in which case it goes to the completion step (307) and,

RO 137883 AO • in the completion step (307) the voltage source (111) and the signal generator (110) from figure 1 are turned off and the user is alerted by a buzzer controlled by the central unit and, • the procedure ends in the final state (308) following the completion step (307).

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Claims (8)

RO 137883 AO demand 1. Device for reducing pain sensations by means of trans-integumentary electrostimulation with micro currents comprising: • a power supply module and, • a low voltage bipolar alternating signal generator and, • a signal generator control module and, • a pair of electrically conductive flexible cables connected to the signal generator and, • two electrodes each connected by the two cables to the signal generator and which are placed on the body of the human subject at treatment points and characterized in that: the signal generator is powered from the power module and configured to generate electrical biostimulation signals that: • are square-wave bipolar and, • have a symmetrical fill factor, and, • the peak-to-peak voltage is below the 50 volt limit, and, • the generated current, when the generator is operating and skin-contact coupled to the human subject using the wires and electrodes, has a constant value controlled by the control module and has a value in the range of [10, 500] micro Amps and, RO 137883 AO the control module of the generator is configured to execute a program that can be chosen from a list of programs, the program being a sequence of phases of electrical stimulation of tissues and/or nerves, each phase of stimulation being characterized by: • a duration of execution with values in the range [3, 3700] seconds and, • a frequency of the stimulation signal with values in the range [10, 10000] Hertz and, • an intensity of the electric current that can be chosen for each phase by program or user and which is held constant by the signal generator regardless of the impedance of the biological tissues between the two electrodes and, the electrodes are identical in shape, weight and contact area and are made of solid copper of high purity over 95%. 2. The system according to claim 1, characterized in that the two electrodes are made of a plate with a constant thickness and which has a thickness in the range [25%, 150%] of twice the penetration depth of the film electric curtenite in the copper electrodes for the higher frequency used but not higher than 6mm. 3. The system according to claim 2 characterized in that the two electrodes have a surface between 5 and 150 square centimeters. 4. The system according to claim 3 characterized in that the two electrodes have a rectangular shape with sides between 3 and 15 centimeters. RO 137883 AO 5. The system according to claim 1 characterized in that the signal generator generates a constant peak-to-peak voltage for a stimulation phase and has the maximum value of 36V. 6. The system according to claim 1 characterized in that the control module of the generator is configured to execute in order at least one phase for stimulating the regeneration of inflamed tissues and at least one phase for local stimulation of nerves and muscles and/or the nervous system central. » и i 7. The method of using the device according to claim 1 characterized in that a stimulation phase is one of the following: FI) A phase of cleansing the body of toxins" uses the frequency of 727 Hz for 180 sec or, F2) A "Ph adjustment" phase uses the frequency of 811 Hz for 60 sec or, F3) A phase for reducing pain due to internal organs" uses the frequency of 1021 Hz for 720 sec adjustable up to 1800 sec or, F4) A phase to reduce pain due to inflammation of soft tissues and muscles" uses the frequency of 525 Hz for 900 sec adjustable up to 3660 sec or, F5) A phase for releasing blocked negative charges and interrupting the positive pain reaction loop of the nervous system” uses the frequency of 1064 Hz for 3 sec or, RO 137883 AO F6) A phase to "mobilize the liver" so as to eliminate toxins more effectively and which uses a frequency of 44 Hz for 600 sec or, F7) A phase to reduce pain in the genital area, of the sacrum" uses a frequency of 65 Hz for 180 sec: F8) Another phase for releasing blocked negative charges and interrupting the positive pain reaction loop of the nervous system" uses a frequency of 156 Hz for 60 sec or, F9) A phase to reduce osteo-skeletal pain” uses a frequency of 5228 Hz for 240 seconds up to 2880 sec or, FIO) A lymphatic circulation stimulation phase" uses a frequency of 936.8 Hz for 420 sec. each phase can use shorter or longer durations, and the final phase of use, provides that after each stimulation session, the electrodes are passivated by immersion in a liquid solution of water, disinfectants and salts 8. The method of use according to claim 7, characterized in that the sequence of phases of the stimulation program is composed in order of at least one of the phases FI or F2, followed by at least one of the phases F3-F9 and completed by at least one of F1-F2 and FIO phases.