WO2022167768A1

WO2022167768A1 - Programming of a heated transcutaneous electrostimulation device

Info

Publication number: WO2022167768A1
Application number: PCT/FR2022/050219
Authority: WO
Inventors: Martine Paulette Jacqueline GUY; Inna SAVELII
Original assignee: Urgo Recherche Innovation Et Developpement
Priority date: 2021-02-04
Filing date: 2022-02-04
Publication date: 2022-08-11
Also published as: EP4288139A1; FR3119332B1; FR3119332A1

Abstract

Proposed is a method for adjusting a transcutaneous electrostimulation device, the device comprising at least one heating element, at least one electrode, a rechargeable battery connected to the electrode, a control unit coupled to a memory, the control unit being capable of configuring an electric current supplied by the battery and delivered by the electrode. The method comprises the operations consisting in selecting, in the memory, a program associated with several parameters of the electric current delivered by the electrode, each parameter being associated with a value, the program comprising as parameters at least: a voltage of the pulses of the electric current; a duration of the pulses of the electric current; a frequency of the pulses of the electric current, configuring the control unit so that the electric current delivered by the electrode corresponds to the values of the parameters of the selected program.

Description

Title of the invention: PROGRAMMING A DEVICE

HEATING TRANSCUTANEOUS ELECTROSTIMULATION

FIELD OF THE INVENTION

The present invention relates to the technical field of heating transcutaneous electrostimulation devices.

TECHNICAL BACKGROUND

[0002] The pain message is transmitted from the painful area to the brain via nociceptive fibres. Two types of nociceptive fibers are known. The first type is the Aô fibers (A delta) which are involved in the rapid transmission of information to the brain, for example in the case of immediate, intense and very brief pain. The second type of fibers is the C fibers which are the most numerous and which are involved in a slow and lasting transmission of information, for example for persistent and diffuse pain.

[0003] Transcutaneous electrical neurostimulation provides pain relief using an electrical current of an intensity that is specifically adapted. This drug-free method is used daily in pain centers. Transcutaneous electrical nerve stimulation reduces or eliminates pain in all painful muscle and joint tissues, but does not treat the cause of the pain. The electric current is transmitted by electrodes placed on the surface of the skin. In order to facilitate the electrical circuit, a gel is generally used between the electrode and the skin. The electric current creates an electrical excitation of the nerves. Pain is alleviated through two actions. First of all, an immediate action obtained thanks to the reduction in the transmission of pain to the spinal cord, in other words a "gateway effect" is achieved by the transcutaneous electrostimulation device. Then there is a lasting action which is caused by the increase in the secretion of endorphins, natural painkilling hormones secreted by the brain.

[0004] Transcutaneous electrical neurostimulation is therefore a real alternative to analgesics which has been scientifically proven by the medical profession. It also offers immediate and/or lasting pain relief. In addition, it is a solution with very few side effects, unlike the undesirable effects of the most common analgesics and anti-inflammatories such as digestive and/or cardiovascular side effects.

[0005] Furthermore, the therapeutic use of heat, also called

"thermotherapy" to treat pain is a natural method of relieving pain by the local application of heat. Today, the use of heat particular is a recognized method for relieving muscle pain. A local rise in temperature activates blood circulation at a specific location. Thus, the exchanges are facilitated there: more nutrients, water, oxygen... All the elements allowing the repair of the cells are present in abundance.

[0006] Therefore, applied to a painful muscle, the heat facilitates cleaning and repair. Heat decreases the efficiency of transmission of nerve messages. Thus, pain sensations have difficulty passing from the heated area to the brain. This is why a rise in temperature also has a fairly rapid analgesic effect.

[0007] The adjustment of a transcutaneous electrostimulation device can prove to be complex for the general public because the number of combinations of the parameters of the electric current is very large (theoretically infinite). Moreover, only a limited number of these combinations offer optimal therapeutic efficacy. In addition, the intensity of the pain may or may not require rapid relief, which will depend on the characteristics of the electrical neurostimulation. In addition, the type of pain (muscular) and the location of the pain (belly, head...) also require particular parameters of the electric current for greater efficiency.

[0008] There is therefore currently no simple method for adjusting a transcutaneous electrical neurostimulation device which is capable of adapting to different pain situations and which is combined with a heating element.

Summary of the invention

The present invention proposes a method for adjusting a transcutaneous electrostimulation device combined with a heating element. The device comprises at least one heating element, at least one electrode, a rechargeable battery connected to the electrode and to the heating element, and a first control unit coupled to a memory, the control unit being capable of configuring a electric current supplied by the battery and delivered by the electrode, a second control unit suitable for delivering an electric current supplied by the battery to the heating element. The method includes the operations consisting of:

- select, in the memory, a program associated with several parameters of the electric current delivered by the electrode, each parameter being associated with a value, the program comprising at least as parameters:

- a voltage of the electrical current pulses;

- a duration of the electrical current pulses;

- a frequency of the electrical current pulses;

- configuring the first control unit so that the electric current delivered by the electrode corresponds to the values of the parameters of the selected program; - optionally operate the heating element via the second control unit.

[0010] Such a method improves the efficiency, the use and the safety of use of a transcutaneous electrostimulation device. Indeed, the device comprises a memory in which a program is stored. This program is associated with at least three of the main parameters of the electric current which will be sent to the area of pain, and each of these parameters is associated with a value. These parameters and their respective values define the conditions necessary to obtain an electrical current configuration that acts on pain without user intervention (for example a manual configuration) being necessary. The user can optionally activate the heating element of the device in order to provide localized heat. In addition, the method for adjusting a transcutaneous electrostimulation device according to the invention allows a user to use the device alone for parts of the body that are more difficult to access because calling up a program does not require little or no user action; it is therefore possible for a single user to adjust the device, even if it is placed on areas of the body that are less easily accessible, for example the shoulder.

According to different embodiments, any combination of at least one of the following characteristics can be implemented:

- selecting a program comprises the operations consisting of selecting a default program, supplying a default value, stored in the memory, associated with each parameter of the selected default program;

- selecting a program further comprises the operation consisting in selecting, by user action on a first selection member, a new value of at least one parameter of the electric current delivered by the electrode;

- the new selected value of at least one parameter is an intensity value of an electric current;

- selecting a program further comprises the operation consisting in selecting sequentially, by user action on a second selection device, a program from among at least two programs stored in the memory;

- a selection operation further comprises emitting, by a light-emitting device, a light signal for each new selection;

- one of the operations consisting in selecting a program further comprises emitting, by a sound emitting device, a sound which uniquely identifies the selected program;

- the memory storing a first program for which the width of the pulses of the electric current delivered by the electrode is between 50 and 500 microseconds inclusive, preferably between 150 and 250 microseconds inclusive or between 50 and 120 microseconds inclusive, the current pulse frequency electric delivered by the electrode is between 60 and 140 hertz terminals inclusive, preferably between 80 and 120 hertz terminals inclusive or between 60 and 110 hertz;

- the memory storing a second program for which the width of the electric current pulses is between 50 and 500 microseconds inclusive, preferably between 150 and 250 microseconds inclusive, the frequency of the electric current pulses is between 2 and 8 hertz terminals included, preferably between 3 and 6 hertz terminals included;

- the electrical current pulses delivered by the electrode are generated continuously, for example for the first program and the second program;

- the memory storing a third program for which the width of the electric current pulses is between 50 and 500 microseconds inclusive, preferably between 150 and 250 microseconds inclusive, the frequency of the electric current pulses delivered by the electrode comprises: a first pulse frequency of the electric current comprised between 60 and 140 hertz terminals inclusive, preferably between 80 and 120 hertz terminals inclusive; and a second electric current pulse frequency of between 2 and 8 hertz, terminals inclusive, preferably between 4 and 6 hertz, terminals inclusive; a first duration for generating the pulses according to the first frequency and a second duration for generating the pulses according to the second frequency, the first duration and the second duration being substantially equal;

- the memory storing a fourth program for which the frequency of the electric current pulses delivered by the electrode is between 1 and 150 hertz terminals inclusive, the frequency of the pulses increasing and decreasing as a function of time in order to form a triangle signal;

- the width of the pulses of the electric current delivered by the electrode is between 50 and 500 microseconds inclusive, preferably between 50 and 250 microseconds inclusive, the width of the pulse decreasing for each increase in the frequency of the pulses and increasing for each decrease in pulse frequency;

- the electrical current pulses delivered by the electrode are generated in discontinuous cycles;

- the memory stores a fifth program which successively executes the first, second, third and fourth programs repeatedly, no electrical signal being emitted between each repetition so that each successive execution of the three programs has a duration of between 45 and 75 seconds , preferably substantially equal to 60 seconds;

- the memory storing a sixth program comprising six phases forming a repeatable cycle: - a first phase in which pulses of electric current are generated with a frequency between 60 and 140 hertz terminals inclusive, preferably between 80 and 120 hertz terminals inclusive;

— a second phase in which pulses of electric current are generated with a frequency of between 60 and 140 hertz, terminals included, preferably between 80 and 120 hertz, terminals included, their generation being carried out according to a periodicity of between 1 and 8 hertz, terminals included , preferably between 1 and 3 hertz terminals included;

- a third phase in which pulses of electric current are generated with a frequency between 40 and 120 hertz terminals inclusive, preferably between 60 and 100 hertz terminals inclusive;

— a fourth phase in which pulses of electric current are generated with a frequency of between 40 and 120 hertz, terminals included, preferably between 60 and 100 hertz, terminals included, their generation being carried out according to a periodicity of between 1 and 8 hertz, terminals included , preferably between 1 and 3 hertz terminals included;

- a fifth phase in which pulses of electric current are generated with a frequency between 20 and 100 hertz terminals inclusive, preferably between 40 and 80 hertz terminals inclusive;

— a sixth phase in which pulses of electric current are generated with a frequency of between 20 and 100 hertz, terminals included, preferably between 40 and 80 hertz, terminals included, their generation being carried out according to a periodicity with a frequency of between 1 and 8 hertz terminals included, preferably between 1 and 3 hertz terminals included; and for which the width of the electric current pulses is between 50 and 500 microseconds inclusive, preferably between 80 and 120 microseconds inclusive;

— the electrical current pulses are delivered by a first cycle of duration tl during which the pulses generated continuously, the first cycle being followed by a second cycle of duration t2 during which no pulses are generated, tl being greater than t2;

— the voltage value of the electric current is between 3.5 and 30 volts, terminals included;

- control, by user action on a third selection member, the second control unit so that an electric current is delivered to the heating element;

- the second control unit is further coupled to the memory, the memory storing a seventh program controlling the delivery, by the second control unit, of the electric current supplied by the battery to the heating element. - the heating element is preferably located under the electrodes and is made of flexible conductive metal. The diffused temperature is preferably below 43°C, more preferably between 38 and 42°C.

The present invention also proposes a computer program comprising program code instructions for the execution of the steps of the method according to the invention when said program is executed on a control unit of the transcutaneous electrostimulation device.

[0013] A computer-readable information medium on which the computer program is recorded is also proposed.

[0014] A transcutaneous electrostimulation device is also proposed, comprising:

- at least one heating element;

- at least one electrode;

- a rechargeable battery connected to the electrode;

- a first control unit coupled to a memory, the control unit being adapted to configure an electric current supplied by the battery and delivered by the electrode, the memory comprising program code instructions of the program according to the invention;

- a second control unit capable of controlling the delivery of an electric current supplied by the battery to the heating element.

[0015] The device may further comprise:

- the battery, the first and the second control unit and the memory are arranged in a case comprising a bottom forming a surface;

- the electrode is placed on a flexible material which is substantially in the same plane as the bottom of the case;

- the heating element is placed in the flexible material;

- the heating element is configured to heat to a temperature below 43°C, preferably to a temperature between 38°C and 42°C, terminals included. BRIEF DESCRIPTION OF FIGURES

Embodiments of the invention will now be described by means of non-limiting examples of the invention, and with reference to the figures, where:

[0017] [fig.l] is an example of a top view of a device according to the invention;

[0018] [fig.2] is a second example of a top view of a device according to the invention;

[0019] [fig.3] is a generic representation of current intensity as a function of current pulse time;

[0020] [fig.4] is a representation of the current pulse width of a first example of a current pulse program;

[0021] [fig.5] is a representation of the width of the current pulses of a second current program example;

[0022] [fig.6] is a representation of the frequency versus time of a third example of a current pulse program;

[0023] [fig.7] is a representation of the width of the current pulses in the example of [fig.6];

[0024] [fig.8] is a representation of the frequency versus time of a fourth example of a current pulse program;

[0025] [fig.9] is a table presenting an example of the parameters of the current program of [fig.8];

[0026] [fig.10] is a representation of the width of the current pulses in the example of [fig.9];

[0027] [fig.l 1] is a representation of the frequency versus time of a ninth example of a current pulse program;

[0028] [fig.12] is a representation of the frequency as a function of time of a tenth example of a current pulse program similar to the first program;

[0029] [fig.13] is a representation of the frequency versus time of an eleventh example of a current pulse program;

[0030] [fig.14] is a schematic example of a device according to the invention;

[0031] [fig.15] is an example of a programming method according to the invention;

[0032] [fig.16] is a photograph of an example of a heating element.

DESCRIPTION OF EMBODIMENTS OF THE INVENTION

The present invention relates to the adjustment or the programming of a device for transcutaneous electrostimulation and heating. Such a device makes it possible to relieve immediately and/or durably a pain which can be, but not limited to, muscular, ... using an electric current of an intensity and a suitable frequency.

[0034] With reference to [fig.14], a schematic example of a device 600 for transcutaneous electrostimulation is discussed. The device comprises at least one electrode 610 which is an electrically conductive device which makes it possible to bring electrical energy to the level of the skin of the part of the body on which it is placed. Electrical energy is typically direct current type electrical current. Direct current can be dispensed discontinuously. The electrode generally comprises a first electrically conductive face, and a second face which is insulating in order to prevent any electrical contact between this second face and another object or body or body part.

The device further comprises at least one heating element 612. The heating element can also be called heating element. The heating element produces heat when it receives (it is powered by) an electric current. For instance, the heating element can be an electrical resistor. The heating element is preferably a flexible conductive metal material. The [fig.16] is a photograph of an example of a heating element which comprises two flexible conductive metal resistors arranged on a single plastic support and whose connection points to the battery (not shown) are arranged opposite each other on the other to simplify their battery connection. The heating element is preferably arranged so that it does not interfere with the operation of the electrode. For example, the heating element can be placed between the first electrically conductive face and the second face which is insulating. In another example, the heating element can be placed between the casing and the flexible electric insulating material; the heating element is thus arranged on the second face. In another example, the heating element is arranged in the second face which is insulating. The heating element is supplied with electricity by the battery. In examples, the power supply to the heating element can be controlled by software. The heating element can be configured so that the heating temperature is less than 43°C, preferably between 38 and 42°C (terminals included), thus making it possible to avoid overheating the skin locally and to limit the consumption of battery power. The heating element can be programmed by the software so that the heating temperature remains below 43°C, preferably between 38 and 42°C.

[0036] In some embodiments, the electrode may comprise a conductive gel which facilitates the transmission of electrical energy between the electrode and the skin, and avoids skin irritation at the level of the skin. The conductive gel is therefore deposited on the conductive face of the electrode.

[0037] In certain embodiments, the conductive gel can be an adhesive gel which is deposited on the electrode before the device is used. The adhesive gel can be placed between two sheets (or even protective films) which hold and protect it before it is applied to the electrode. The two sheets can be made of plastic material. When the gel is placed on the electrode, one of the two sheets can be removed, thus releasing one of the faces of the adhesive gel which will be brought into contact with the electrode. The adhesive properties of the gel keep it on the electrode. The second sheet is then removed, so that the electrode has the adhesive gel on its conductive side. When the device is deposited on the area of the body to be treated, it can be kept fixed on the body thanks to the adhesive properties of the adhesive gel. When the device is not in use, the adhesive gel which is still on the electrode can be protected by replacing one of the protective films on it.

The device 600 further comprises a battery 606. The battery is an electrochemical element in which chemical energy is converted into electrical energy. The battery is rechargeable, i.e. it is possible to store new electrical energy, for example by connecting the battery to an external source of electricity. The rechargeable battery can be of any technology such as, but is not limited to, lithium ion, lithium polymer, ... The rechargeable battery is connected to the electrode, i.e. the electrical energy produced by the battery can be transmitted to the electrode.

The battery produces a DC-type current and therefore has a positive output terminal and a negative output terminal. Electrode 610 is therefore broken down into two sub-electrodes: a positive electrode which is connected to the positive terminal of the battery and a negative electrode which is connected to the negative terminal of the battery. When the electrode is placed on the area of skin to be treated, the electric current therefore passes from the negative electrode to the positive electrode.

Still with reference to [fig.14], the transcutaneous electrostimulation device 600 includes a control unit 608 which includes a first control unit (UC) 608a and a second control unit 608b. In this example, the first and the second control unit form a set 608; we can therefore consider that there is only one control unit in this example [fig.14]. In this example, the two control units are coupled to the memory. Examples of the first and second control unit are now discussed.

The function of the first battery control unit (CPU) 608a is to configure (we can also say conform) the electric current supplied by the battery so that it has the desired shape. The electrical energy produced by the battery is therefore transformed into an electrical signal which is transmitted to the electrode, and the latter delivers this electrical signal to the area of the body to which the electrode (and therefore the device) is applied. The first control unit is programmable, i.e. it can be configured to produce different electrical signals from the energy supplied by the battery. The control unit is therefore similar to a computing unit.

The function of the second control unit (UC) 608b of the battery is to supply the heating element with electric current supplied by the battery so that the heating element produces heat; it is therefore capable of delivering an electric current supplied by the battery to the heating element. In examples, the second control unit can also be coupled to a memory and can be programmable, that is to say it can be configured by the program to supply electric current to the heating element. The second control unit is in this example similar to a calculation unit.

It will be understood that in the particular example of [fig.14], the first 608a and the second 608b control units are combined into a single control unit 608 coupled to the memory 604. It will be understood that the first 608a and the second 608b control units can both be independent, and coupled to the same memory or else each to a respective memory. It will be understood that the second control unit can be similar to a switch which opens or else closes the electrical circuit connecting the battery to the heating element.

The transcutaneous electrostimulation device 600 also includes a memory which is coupled with the control unit. In the example of [fig.14], the control unit and the memory are coupled via a BUS 602, it being understood that they can be coupled (that is to say connected) by n' any means. Memory is memory for storing instructions and data needed to run a computer program. The memory may be, but is not limited to, non-volatile memory, including for example semiconductor memories such as EPROMs, EEPROMs, flash memory. All the elements 602, 604, 606, 608 can be supplemented by or incorporated into ASICs (acronym for “application-specific integrated circuits”).

The computer program may include instructions that can be executed by the control unit 608. The instructions include means for causing the system to execute the method according to the invention. The program may be recordable to any data storage medium, including memory 604. The program may, for example, be implemented in digital electronic circuits, or in computer hardware, firmware, software or combinations thereof. The program may be implemented as a device, such as a product tangibly embodied in a machine-readable storage device for execution by a programmable processor. The steps of the method according to the invention can be executed by a programmable processor executing an instruction program to execute functions of the method by operating on input data and generating an output. The control unit may be or may include the programmable processor. The processor can thus be programmed and coupled to receive data and instructions, to transmit data and instructions to a data storage system, to at least one input device and to at least one output device. The computer program can be implemented in a high-level procedural or object-oriented programming language, or in assembly or machine language if necessary. In any case, the language can be a compiled or interpreted language. The program can be a full installer or an updater. The application of the program on the system entails in all cases instructions for the execution of the method.

[0046] With reference to [fig.15], examples of the method for adjusting the transcutaneous electrostimulation device are now discussed. The different examples can be combined with each other, the combinations not being limited to that shown in [fig.15].

In embodiments according to the invention, the method may comprise an operation of powering up the transcutaneous electrostimulation device. Powering up means that the control unit is able to receive instructions from a computer program stored in the memory, or even an instruction from a user.

[0048] In embodiments according to the invention, the transcutaneous electrostimulation device may comprise a power-up member which, in response to a user action (1300), powers up the device (1302). The member can be a switch, for example a button, on which the user presses, for example, for a predetermined duration.

In examples, the device may comprise a sound emitting device, for example a loudspeaker or even a buzzer. After the user has pressed the power-up device, a sound is emitted (1304), for example a beep, confirming that the device is indeed powered up.

[0050] In examples, the device may comprise a light-emitting device, for example a light-emitting diode (LED). After the user has pressed the power-up device, a light signal is emitted (1304). The light signal can be brief, for example of the order of a few seconds, or on the contrary the light signal can be constantly on as long as the device is powered.

[0051] Next, a selection of a program is made. The selection is made in the device memory, i.e. the program is stored in the memory. The selection means that there is identification of the program in the memory, and that the control unit can access the program, for example for its execution. The program is a list of several parameters of the electric current to be delivered to the electrode (and therefore to be delivered by the electrode) in which each parameter is associated with a value. The electric current delivered by the control unit to the electrode is a succession of current pulses, i.e. the current is in a variable state. The pulses are of the rectangular signal type. The variation of the intensity of the current over time produces the pulses, and a pulse is a variation of short duration of a physical magnitude of the current with return to the initial state. The parameters of the current represent physical characteristics of the latter which can vary.

One of these parameters is the voltage of the current pulses. Its value is expressed in volts. It is understood that it is equivalent to speak of the intensity of the current impulses. Another of these parameters is the duration of the electrical pulses. The duration of the pulses represents the time during which a voltage is emitted; for example, for a rectangular signal, it is the time during which the signal remains high. Its value can be expressed in seconds or in sub-multiples.

The third of these parameters is the frequency of the electric current pulses. The frequency represents the number of pulses that are emitted per second. Its value is expressed in Hertz.

It will be understood that these parameter values are particularly suitable for characterizing electrical pulses of the rectangular type that can be used for transcutaneous electrostimulation. [fig.3] illustrates a generic example of rectangular electrical pulses that can be programmed. The two pulses have a height which represents a current intensity. Their pulse widths are identical. The time T that elapses between two rising edges of two successive pulses is the periodicity between two pulses. In the example of [fig.3], the pulses are unidirectional, i.e. the current is polarized. In examples of programs which will be described below, the pulses can be bidirectional, that is to say that the current is depolarized and therefore the negative and positive poles are reversed with each pulse.

In examples, the memory of the device can store a first program shown schematically in [fig.4], in which the voltage value of the electric current is between 3.5 and 21 volts, terminals included. Note that in [fig.4] the intensity of the pulses is represented as a function of time. The pulses are bidirectional, the voltage values are therefore given in absolute value. The width of the electric current pulses is between 50 and 500 microseconds inclusive, preferably between 150 and 250 microseconds inclusive. In another example (not shown in [fig.4]), the width of the electric current pulses is preferably between 75 and 150 microseconds, limits included. In [fig.4], all the pulses have a substantially equal width with a corresponding value of 180 microseconds. The frequency of the pulses is between 60 and 140 hertz limits inclusive, preferably between 80 and 120 hertz limits inclusive. In another example (not shown in [fig.4]), the frequency of the pulses is preferably between 60 and 110 hertz limits included. In [fig.4], the frequency is 100Hz. The first program is a high frequency simulation. It is suitable for continuously stimulating nerve fibers of type Aa and A| to reduce the message transmitted by the nerve fibers of the pain Aô and C. This first program thus produces a fast relief, but not very durable. In addition, the user can vary the value of the intensity of the electric current until he finds a value that suits him, that is to say a value at which the zone treated responds, or in other words an intensity value for which the user is relieved.

In examples, the memory of the device can store a second program shown schematically in [fig.5], in which the voltage value of the electric current is between 7 and 30 volts, terminals included. The intensity of the pulses is represented as a function of time in [fig.5]. The pulses are also bidirectional. The width of the electric current pulses is between 50 and 500 microseconds inclusive, preferably between 150 and 250 microseconds inclusive. In [fig.5], all the pulses have a substantially equal width with a corresponding value of 200 microseconds. The frequency of the pulses is between 2 and 8 hertz limits inclusive, preferably between 3 and 6 hertz limits inclusive. In [fig.5], the frequency is 4Hz. The second program is a low frequency simulation. It is suitable for stimulating the secretion of endorphins by the brain, which provides delayed but lasting pain relief. The voltage of the current can be selected around the upper limit mentioned above, for example between 20 and 30 volts in order to improve the aforementioned effects.

In examples, the pulses of the first program and of the second program are generated continuously. In other words, there are no cycles.

In examples, the memory of the device can store a third program shown schematically in [fig.6]. This third program comprises two successive phases: a first phase where the pulses are generated at high frequency and a second where the pulses are generated at low frequency. The frequency of the pulses of the first phase can be between 60 and 140 hertz limits inclusive, preferably between 80 and 120 hertz limits inclusive. The frequency of the pulses of the 2nd phase can be between 2 and 8 hertz limits inclusive, preferably between 4 and 6 hertz limits inclusive. [fig.6] illustrates these two phases with a first phase during which the pulses are generated at a frequency of 100 Hz and a second phase during which the pulses are generated at a frequency of 4 hertz. The width of the electric current pulses can be between 50 and 500 microseconds inclusive, preferably between 130 and 220 microseconds inclusive. In [fig.7], the pulses are represented with a width of 150 microseconds for the first phase and 200 microseconds for the second phase. In the example of [fig.7], the duration of the first and of the second phase are identical, it being understood that they can be of different durations. The first and the second phase form a cycle. In examples the cycles can be generated continuously. In examples, and preferably, the cycles are discontinuous with a break between each cycle of a duration which can be for example between 1 and 3 seconds. In the example of [fig.7], a cycle comprising the first and the second phase has a duration of 6 seconds, and a pause of 1 second separates each generated cycle. The voltage value of the electric current can be between 2.8 and 29 volts terminals included. Note that in [fig.7] the width or duration of the pulses is represented as a function of time and that the pulses are bidirectional. The third program is therefore a combination of the first program (high frequency, low intensity with for example 17V maximum) and the second program (low frequency, high intensity with for example 24V maximum) which is generated discontinuously. The relief provided by the third program is immediate and lasting.

[0060] In examples, the memory of the device can store a fourth program schematically shown in [fig.8]. It is a question of generating successions of cycles of current impulses where for each cycle the frequency varies according to time in order to form a triangle signal: the frequency increases gradually during the first half of the cycle and decreases gradually during the second half of the cycle to reach at the end of the cycle a frequency which is equal to the starting frequency of the first half of the cycle. In examples, the frequency of the electric current pulses is between 1 and 150 hertz terminals inclusive. Pulse width decreases with each increase in pulse frequency, and conversely increases with each decrease in pulse frequency. In other words, the first half of the cycle sees the pulse width gradually decrease while the second half of the cycle sees the pulse width gradually increase. The voltage value of the electric current can be between 2.8 and 26 volts terminals included. The [fig.9] is an example of frequency and pulse width variations for a half cycle. The same inverted values can be used for the next half cycle. The width of the electric current pulses can be between 50 and 500 microseconds inclusive, preferably between 50 and 250 microseconds inclusive. In the example of [fig.9], the pulse time of all the pulses is equal to 0.5 seconds, and the sum of the pulse times for a half cycle is 7 seconds. A complete cycle is therefore 14 seconds. Note that in [fig.10] that the width or duration of the pulses is represented and that the pulses are bidirectional. The values shown in [fig.10] correspond to those in the table in [fig.9]. It can thus be observed in [fig.10] that the first pulse comprises two pulse widths of 200 microseconds over a pulse time of 0.5 seconds at a frequency of 2 Hertz, and the last pulse of the half-cycle (rising ) comprises two 96 microsecond pulses over a pulse time of 0.5 seconds and at a frequency of 100 Hertz. This last pulse of the rising half-cycle is also the first pulse of the descending half-cycle, and the first pulse of the ascending half-cycle becomes the last pulse of the descending half-cycle. In examples the successive cycles can be generated continuously, that is to say without a pause between them. In examples, and preferably, the cycles are discontinuous with a pause between each cycle which can be comprised for example between 1 and 3 seconds. The fourth program causes rapid and lasting pain relief accompanied by a massage sensation which is notably caused by the progressive and simultaneous variation of the frequency and the pulse width of the electrical signal.

[0061] In examples, the memory of the device can store a fifth program which successively executes the first, third and fourth programs repeatedly. Between each repetition, no electrical signal is emitted so that each successive execution of the three programs lasts between 45 and 75 seconds, preferably around 60 seconds.

In examples, the memory of the device can store a sixth program which is a combination of the first program executed successively with a respective frequency substantially equal to 100 hertz, then 80 hertz and then 60 hertz, and of the second program executed successively with a respective frequency substantially equal to 100/2 hertz, then 80/2 hertz and then 60/2 hertz. The width of the pulses can be between 80 and 120 microseconds, and preferably substantially equal to 100 microseconds. This program is particularly well suited for dysmenorrhea.

In examples, the memory of the device can store a seventh program similar to the first program, for which the frequency of the pulses is between 80 and 120 hertz, preferably substantially equal to 100 hertz and the width of the pulses is between 80 and 120 microseconds, preferably substantially equal to 100 microseconds. Dysmenorrhea can be treated using this seventh program.

[0064] In examples, the memory of the device can store a ninth program schematically represented in [fig.l 1], This ninth program comprises six successive phases forming a cycle, the cycle being able to be repeated as long as the ninth program is executed. :

- a first phase where the pulses of electric current are generated discontinuously at a frequency fl for a time tl;

- a second phase where the pulses of electric current are generated at frequency f2 during a time t2 with a low frequency periodicity;

- a third phase where the pulses of electric current are generated discontinuously at a frequency f3 during a time t3;

[0068] - a fourth phase where the electrical current pulses are generated at a frequency f4 during a time t4 with a low frequency periodicity;

- a fifth phase where the electric current pulses are generated discontinuously at a frequency f5 during a time t5;

- a sixth phase where the pulses of electric current are generated at a frequency f6 during a time t6 with a low frequency periodicity.

In the examples of [fig.ll], the times t1, t2, t3, t4, t5 and t6 are equal or even substantially equal. For example, the duration of each phase is 60 seconds, it being understood that other values can be envisaged, for example 30s, 45s, 75s, 90s, 105s, 120s,... In the examples of [fig.ll ], the repetition of high frequency stimulation during the second, fourth and sixth phases are identical or else substantially identical, but their respective high frequency values differ. In the examples of [fig.l 1], the frequencies f1 and f2 can be between 60 and 140 hertz, limits included, preferably between 80 and 120 hertz, limits included. A particular example is a frequency fl and f2 equal to 100Hz. In the examples of [fig.11], the frequencies f3 and f4 can be between 40 and 120 hertz limits inclusive, preferably between 60 and 100 hertz limits inclusive. A particular example is a frequency f3 and f4 equal to 80Hz. In the examples of [fig.11], the frequencies f5 and f6 can be between 20 and 100 hertz limits inclusive, preferably between 40 and 80 hertz limits inclusive. A particular example is a frequency f5 and f6 equal to 60Hz. In the examples of [fig.l 1], the low frequency periodicity of the second, fourth and sixth phases is between 1 and 8 hertz limits inclusive, preferably between 1 and 3 hertz limits inclusive; the second, fourth and sixth phases are also said to each be a “bursts” mode in which the generation of the pulses is interspersed with pauses with a low frequency periodicity. For example, the low frequency periodicity of the “burst” mode of the second, fourth and sixth phases is 2Hz, with a work phase of 0.25s and a pause phase of 0.25s. In the examples of [fig.11], the width of the electric current pulses can be between 50 and 500 microseconds inclusive, preferably between 80 and 120 microseconds inclusive. In the examples of [fig.ll], the voltage value of the electric current can be between 2.8 and 29 volts, terminals included. In examples, a short pause between each phase can be introduced at the end of each phase so that the transition from one phase to the other is more comfortable and pleasant for the user. For example, when the times t1, t2, t3, t4, t5 and t6 are equal (or still substantially equal) and have a value of 60s, each phase will have an active time of 59 seconds and a pause of 1 second. It will be understood that the pause time can be 2, 3, 4 or even 5 seconds. The first, third and fifth phases are discontinuous, and therefore each of them has at least one active time (ON) followed by a time inactive (OFF). In examples, these active and inactive times are identical for each phase; for example, they can be active for 5 seconds and inactive for one second. One or more of the examples of [fig.l 1] can be combined with each other. In the examples discussed, the frequencies f1, f2 and f3 decrease (for example 100Hz, 80Hz, 60Hz); it is understood that the frequencies f1, f2 and f3 can on the contrary increase (for example 60Hz, 80Hz, 100Hz).

In examples, the memory of the device can store a tenth program shown schematically in [fig.12]. The tenth program is similar to the first program schematically shown in [fig.4]. [fig.12] differs from [fig.4] in that all the pulses have a substantially equal width with a corresponding value of 100 microseconds.

[0073] In examples, the memory of the device can store an eleventh program schematically represented in [fig.l 3]. This eleventh program includes the characteristics of one and/or any combination of the first, third, fourth and fifth programs already discussed. The eleventh program does not generate the pulses continuously and the generation comprises two successively repeated cycles: a first cycle of duration t1 during which the pulses generated continuously and a second cycle of duration t2 during which there is a pause (the pulses do not are no longer generated). The duration of t1 can be greater than that of t2. In the example of [fig.l 3], the pulses have a frequency substantially equal to 85 Hz for a pulse width substantially equal to 75 microseconds. The first cycle has a duration t1 (substantially) equal to 3 seconds and the second cycle has a duration t2 (substantially) equal to 1 second.

In examples, the duration of the aforementioned programs can be between 20 and 35 minutes, preferably the duration of a program is substantially equal to 30 minutes, or even 60 minutes for better efficiency while preserving the level of charge. drums.

In examples, the value of the voltage of the electric current for the programs is between 3.5 and 15 volts, terminals included. These values showed good stimulation efficiency while being adapted to the voltages that the rechargeable battery can deliver.

Back to [fig.15], examples of selecting a program stored in memory are discussed. In [fig.15], the selection is presented as being performed after the device has been powered up, it will however be understood that the selection can be performed at any time, for example it is possible to select another program then even if a program is running. In general, a necessary and sufficient condition for a program to be able to be selected is that the device is powered up. [0077] In examples, the selection includes selecting a default program. For example, if the memory comprises several programs, one of these programs is automatically selected to generate the electric current delivered by the electrode. In one example, this default program is the first program previously discussed which provides rapid pain relief. The selection of the default program can be accompanied by the provision of a default value for each parameter of the default program; each value is included in the memory.

In examples, the user can select a program (1320), or even change the default program if it was selected after the device was powered up. In [fig.15], the selection is made following the default selection of the first program (operation not shown). The selection is obtained by a user action on a selection device (1310), for example a button arranged on the device, which triggers the selection of another program included in the memory. When the memory comprises several programs, the programs can be selected sequentially, that is to say that each new user action on the selection device triggers the selection of a new program, and when all the programs have been proposed to the user, the default program is again proposed for a new user action on the selection member. This allows the user to continuously cycle through all programs one by one. The last program selected is the last program presented to the user, either the program selected by default or the program selected following the last user action on the selection device.

[0079] In examples, the selection body makes it possible to propose a new program, but also to propose a program previously presented. This allows the user to more quickly select the program he wishes to have for example in case he missed it. In one example, the selection member comprises two selection members, for example a “plus” button and a “minus” button, where each member makes it possible to scroll through the programs in its own direction; for example, the “plus” button makes it possible to progress in an ordered list of programs in one direction (for example in ascending direction) while the “minus” button makes it possible to progress in the list in the opposite direction.

[0080] In examples, the selection of a program may be accompanied by a sound which uniquely identifies the selected program. It is understood that the device then comprises a sound emission device, which can be but is not limited to, a loudspeaker, a buzzer,... The identification of the selected program can be carried out for example using a number of beeps where each number is associated with a single program; for example the first program with a beep, the second with two beeps, and so on.

In examples, the selection may be accompanied by a light signal emitted by the light-emitting device.

[0082] In examples, the selection may be accompanied (1322) by a sound which uniquely identifies the selected program, as previously selected, or even by a sound which has the sole purpose of informing that the selection is confirmed.

Then, once the selection has been made, the control unit is configured so that the electric current delivered by the electrode corresponds to the values of the parameters of the selected program. In other words, the control unit is configured to perform the electrical stimulation associated with the program. This configuration is therefore a programming (or a reprogramming) of the device.

In examples, the selection can be followed by a confirmation of the selection. Selection Confirmation allows the user to confirm to the device that they want the selected program to run. In one example, this can be achieved with a particular user action on the selector.

In examples, the confirmation of the selection can be implicit with the start of the stimulation (and therefore once the control unit has been configured), for example by performing a user action on the selection organ. (1330).

[0086] In examples, the selection of the program can comprise a user action making it possible to select (1340) a new value of a parameter of the selected program. The selection of this parameter value can be made via a selection device.

In examples, the device used to select this parameter value can be the same as that used to select the program. In one example, the selection member comprises two buttons, a “plus” button and a “minus” button. Each action on the "plus" button increases the value, and conversely each user action on the "minus" button decreases the value of the parameter (1342). In order to be able to distinguish between a program selection and a modification of a parameter value when the same selection device is used, the duration of the user action on the device can be used: a long action (for example press the button for more than three seconds) will be interpreted by the device as being a program selection, and conversely a short action (for example pressing the button for less than three seconds) will be interpreted by the device as being a value selection of setting. Returning to [fig.15], the user can control (1350) the second control unit so that an electric current is delivered to the heating element. In examples, the user can actuate a third selection member. It will be understood that the decision (1350) to implement whether or not the heating element is turned on can be made at any time after the device has been powered up (1302); that is to say that the user action on the second control unit can be performed after each of the steps 1304 to 1342. Following the actuation (1350), the heating element or elements are started. It will be understood that the heating element can be turned off at any time, after it has been started, by controlling the second control unit, by action of the user, that the electric current is no longer delivered to the heating element; for example the user can actuate the third selection member so that the heating element is no longer supplied with electricity. In examples, the duration of operation of the heating element can be predetermined. In these examples, the second control unit can be coupled to a memory storing a program capable of configuring the control unit so that it supplies the heating element with electricity for the predetermined time.

[0088] In examples, the choice of a parameter value and/or the operation of the heating element and/or the stopping of the heating element can be accompanied by a sound and/or a light signal to assist the user in the selection.

For example, the range of parameter values that can be selected may be limited. When the user wishes to leave this range of values, which is not possible, the system can inform the user of this using a sound and/or a light signal.

In examples, the new value selected is an intensity value of the electric current. This allows the user to increase the effect of

F electrostimulation according to his feeling of the electrical stimulation and the relief of his pain obtained.

It is understood that the choice of the intensity value could be made before the start of the stimulation, for example, the user knows what intensity suits him.

[0092] In examples, when the battery is not sufficiently charged to carry out a complete program, the device can inform the user and/or go to safety (the program cannot be carried out) or else be carried out until the battery is empty.

In examples, when the battery is not sufficiently charged to carry out a complete program (over its entire duration), it is possible to operate the device by connecting the rechargeable battery to an external energy source. The device can then operate on mains power.

[0094] With reference to [fig.l], an example of the device is now discussed. The [fig.l] is a photograph of the device. In [fig.l], the device according to the invention comprises a housing 12 in which the battery, the first and the second control unit and the memory are arranged. The case protects them from external elements that could damage them (dust, water, etc.). The case can therefore be waterproof. The box may include a power-up and/or power-down member 120. The box may also include a first member for selecting a program and/or a second member for selecting a parameter value. The housing may also include a third control selection member of the second control unit. In the example of [fig.l], the first and the second organ are combined and identical: it is a “plus” button 122a and a “minus” button 122b. Still in [fig.l], the third member is a button 128. The case of this example includes an LED 124 acting as a light indicator and a buzzer (not shown). The housing includes two electrodes, one positive and one negative, which are not directly visible with the top view; more precisely, the second face (insulating) of the electrode 10a, 10b is visible. The two electrodes are connected and fixed to the casing, thus forming a compact device.

[0095] The casing can be made of a solid and protective polymer material, for example ABS plastic (Acrylonitrile butadiene styrene) or even PET plastic (polyethylene terephthalate). The housing 12 and the electrodes 10a, 10b can be covered on this face with a flexible and electrically insulating material of the silicone type. The electrodes further comprise in this example tabs 16a, 16b, 16c, 16d which facilitate removal of the device which is held on the skin for example using an adhesive gel.

The housing 12 comprises a bottom which forms a surface, for example a plane. This surface is preferably coincident with the surface of the electrodes 10a, 10b in order to improve the placement of the device on the area to be treated. The electrode is therefore substantially in the same plane as the bottom of the case. The electrically conductive surfaces of the electrode are accessible. These surfaces can receive the gel, for example the adhesive gel.

The housing 12 may include an opening which gives access to an interface making it possible to electrically connect the battery to an external source of electricity, for example to recharge the battery. The interface can be of any type. In one example, the interface is a USB interface and it can be connected to an electrical source using a USB 30 cable. Any technique for recharging the battery can be used. For example, magnetic induction technology can be used; therefore the aforementioned opening is not necessary in this example.

The device shown in [fig.l] is particularly suitable for being placed on the stomach in order to relieve dysmenorrhea. In particular the electrodes 10a to 10b have a shape well suited to cover the organs responsible for pain when the device is placed on the stomach. The shape of the electrodes can allow application to the lower back, for example to relieve lumbago. The heating element (not shown) of [fig.l] can have substantially the same shape as the electrodes 10a and 10b so that the heat can act on the entire area of the body covered by the device.

In examples, the device of [fig.l] stores in memory at least the ninth, tenth and eleventh programs discussed below. These programs are particularly suitable for, but not limited to, relieving primary dysmenorrhea, as well as pain that may be caused by endometriosis. The program that can be associated with the heating element can also be stored in memory.

[0100] [fig.2] is another example of a device similar to that of [fig.1], except that the electrodes 10a, 10b have a substantially different shape which is particularly suitable for being placed on parts of the body wide, for example at the top of the back on the shoulders and at the bottom of the back on the lumbago area.

In examples, the device of [fig.2] stores in memory at least the first, second, third, fourth and fifth programs discussed above. These programs are particularly suitable for, but not limited to, relieving muscle pain, for example back or lower back pain. The program that can be associated with the heating element can also be stored in memory.

[0102] The devices shown in FIGs. 1 and 2 are adapted to the pathologies to be treated (the selection of programs previously discussed) and to the areas to be applied thanks to their shape. Regarding their shape, it will be understood that the two devices can have electrodes of similar shape, or even identical, to allow the same adhesive gel reference to be used. Furthermore, this makes it possible to simplify the process of development and production of the two example devices shown in FIGs. 1 and 2. The difference in shape between the patches of FIGs. 1 and 2 allows the user to quickly identify which patch to take. In addition, it is possible to put on the cover (not visible in FIGs. 1 and 2) which closes the case 12 on the inside of the device, to place a label with a pictogram or any other diagram representing the place of application. .

[0103] In examples, the box can also comprise wireless communication means making it possible to configure the control unit, for example to carry out the operation of selecting a program and/or the operation of selecting a parameter value. The configuration can for example be carried out with the Bluetooth© protocol between an application for example executed by a smartphone and the control unit.

Claims

[Claim 1] A method of adjusting a transcutaneous electrical stimulation device, the device comprising:

- at least one heating element;

- at least one electrode;

- a rechargeable battery connected to the electrode and the heating element;

- a first control unit coupled to a memory, the control unit being capable of configuring an electric current supplied by the battery and delivered by the electrode;

- a second control unit capable of delivering an electric current supplied by the battery to the heating element; the method comprising the operations consisting of:

- a voltage of the electrical current pulses;

- a duration of the electrical current pulses;

- a frequency of the electrical current pulses;

- configuring the first control unit so that the electric current delivered by the electrode corresponds to the values of the parameters of the selected program, in which selecting a program includes the operations consisting of:

- select a default program;

- provide a default value, stored in memory, associated with each parameter of the selected default program.

[Claim 2] A method according to claim 1, wherein selecting a program further comprises the step of:

- select, by user action on a first selection member, a new value of at least one parameter of the electric current delivered by the electrode.

[Claim 3] Method according to claim 2, in which the new selected value of the at least one parameter is an intensity value of an electric current.

[Claim 4] A method according to any preceding claim, wherein which to select a program further comprises the step of:

- Sequentially select, by user action on a second selection member, a program from at least two programs stored in the memory.

[Claim 5] A method according to any preceding claim, wherein a selection operation further comprises:

- emit, by a light emitting device, a light signal for each new selection.

[Claim 6] A method according to any preceding claim, wherein one of the operations of selecting a program further comprises:

- emit, through a sound emitting device, a sound that uniquely identifies the selected programme.

[Claim 7] A method according to any preceding claim, the memory storing a first program for which:

- the width of the pulses of the electric current delivered by the electrode is between 50 and 500 microseconds terminals inclusive, preferably between 150 and 250 microseconds terminals inclusive or between 50 and 120 microseconds terminals inclusive;

- the frequency of the electric current pulses delivered by the electrode is between 60 and 140 hertz terminals inclusive, preferably between 80 and 120 hertz terminals inclusive or between 60 and 110 hertz.

[Claim 8] A method according to any preceding claim, the memory storing a second program for which:

- the width of the electric current pulses is between 50 and 500 microseconds inclusive, preferably between 150 and 250 microseconds inclusive;

- the frequency of the electrical current pulses is between 2 and 8 hertz terminals inclusive, preferably between 3 and 6 hertz terminals inclusive.

[Claim 9] A method according to any of claims 8 or 9, wherein the pulses of electric current delivered by the electrode are continuously generated.

[Claim 10] A method according to any preceding claim, the memory storing a third program for which:

- the width of the electrical current pulses is between 50 and 500 microseconds inclusive, preferably between 150 and 250 microseconds croseconds bounds included;

- the frequency of the electrical current pulses delivered by the electrode includes:

— a first pulse frequency of the electric current between 60 and 140 hertz terminals inclusive, preferably between 80 and 120 hertz terminals inclusive; and

— a second electric current pulse frequency of between 2 and 8 hertz terminals inclusive, preferably between 4 and 6 hertz terminals inclusive;

- a first duration of generation of the pulses according to the first frequency and a second duration of generation of the pulses according to the second frequency, the first duration and the second duration being substantially equal.

[Claim 11] A method according to any preceding claim, the memory storing a fourth program for which:

- the frequency of the electric current pulses delivered by the electrode is between 1 and 150 hertz terminals included, the frequency of the pulses increasing and decreasing as a function of time in order to form a triangle signal;

- the width of the pulses of the electric current delivered by the electrode is between 50 and 500 microseconds inclusive, preferably between 50 and 250 microseconds inclusive, the width of the pulse decreasing for each increase in the frequency of the pulses and increasing for each decrease in pulse rate.

[Claim 12] A method according to any one of claims 10 or 11, wherein the pulses of electric current delivered by the electrode are generated in discontinuous cycles.

[Claim 13] Method according to the combination of claims 7 to 13, in which the memory stores a fifth program which successively executes the first, second, third and fourth programs in a repeated manner, no electric signal being emitted between each repetition so that each successive execution of the three programs has a duration of between 45 and 75 seconds, preferably substantially equal to 60 seconds.

[Claim 14] A method according to any preceding claim, the memory storing a sixth program comprising six phases forming a repeatable cycle: - a first phase in which pulses of electric current are generated with a frequency between 60 and 140 hertz terminals inclusive, preferably between 80 and 120 hertz terminals inclusive;

- a second phase in which pulses of electric current are generated with a frequency of between 60 and 140 hertz, terminals included, preferably between 80 and 120 hertz, terminals included, their generation being carried out with a periodicity of between 1 and 8 hertz, terminals included , preferably between 1 and 3 hertz terminals included;

- a fourth phase in which pulses of electric current are generated with a frequency of between 40 and 120 hertz, terminals included, preferably between 60 and 100 hertz, terminals included, their generation being carried out with a periodicity of between 1 and 8 hertz, terminals included , preferably between 1 and 3 hertz terminals included;

- a sixth phase in which pulses of electric current are generated with a frequency of between 20 and 100 hertz, terminals included, preferably between 40 and 80 hertz, terminals included, their generation being carried out with a periodicity with a frequency of between 1 and 8 hertz terminals included, preferably between 1 and 3 hertz terminals included; and for which the width of the electric current pulses is between 50 and 500 microseconds inclusive, preferably between 80 and 120 microseconds inclusive.

[Claim 15] Method according to any one of Claims 7, 10 to 13, in which the pulses of the electric current are delivered by a first cycle of duration t1 during which the pulses generated continuously, the first cycle being followed by a second cycle of duration t2 during which no pulse is generated, t1 being greater than t2.

[Claim 16] Method according to any one of Claims 7 to 15, in which the voltage value of the electric current is between 3.5 and 30 volts, terminals included.

[Claim 17] A method according to any preceding claim, further comprising the step of:

- control, by user action on a third selection member, the second control unit so that an electric current is delivered to the heating element.

[Claim 18] A method according to claim 17, wherein the second control unit is further coupled to the memory, the memory storing a seventh program controlling the delivery, by the second control unit, of electric current supplied by the battery to the heating element.

[Claim 19] A computer program comprising program code instructions for carrying out the steps of the method according to any one of claims 1 to 14, 18, when said program is executed on a control unit of the transcutaneous electrostimulation.

[Claim 20] Transcutaneous electrostimulation device, comprising:

- at least one heating element;

- at least one electrode;

- a rechargeable battery connected to the electrode;

- a first control unit coupled to a memory, the control unit being adapted to configure an electric current supplied by the battery and delivered by the electrode, the memory comprising program code instructions of the program according to claim 19;

[Claim 21] Apparatus according to claim 20, wherein:

- the battery, the first and the second control unit and the memory are arranged in a casing comprising a bottom forming a surface;

- the heating element is placed in the flexible material.

[Claim 22] Device according to claim 20 or 21, wherein the heating element is configured to heat to a temperature below 43°C, preferably to a temperature between 38°C and 42°C, inclusive.