Device and method for unattended treatment of a patient.

DEVICE AND METHOD FOR TREATMENT WITHOUT PATIENT ATTENTION

FIELD OF THE INVENTION

The present invention relates to methods and apparatus for treating the patient by means of active elements that supply electromagnetic energy and/or secondary energy in such a way that the treatment area is treated homogeneously without the need for manipulation of the active elements during therapy. .

BACKGROUND OF THE INVENTION

The delivery of various forms of electromagnetic energy to the patient for medical and cosmetic purposes has been widely used in the past. These common procedures include, but are in no way limited to, skin rejuvenation, wrinkle removal, skin tightening and lifting, cellulite and fat reduction, treatment of pigmented lesions, tattoo removal, soft tissue coagulation and ablation. , reduction of vascular injuries, face lifting, muscle contractions and muscle strengthening, etc.

All of these procedures are performed to improve the patient's visual appearance.

In addition to many indisputable advantages of thermal therapy, these procedures also carry certain limitations and associated risks. Among other things is the limited ability of reproducible results, since these depend largely on the treatment techniques applied and the capabilities of the operator. Additionally, if therapy is performed improperly, there is an increased risk of burns and adverse events.

It is very difficult to guarantee a homogeneous distribution of energy if the energy delivery is controlled by manual movement of the operator's hand, which is the most common procedure. Certain stains can be easily undertreated or overtreated. For this reason, devices containing scanning or other mechanisms capable of managing unattended skin have emerged. These devices generally deliver energy without direct contact with the treated area, and only in a limited, well-defined area with no apparent irregularities. Maintaining the same distance between the treated tissue and the energy generator or maintaining the necessary contact with the tissue can be a challenge when treating irregular or bumpy areas. Therefore, the use of commonly available devices in specific areas that also differ from patient to patient (for example, the face) could be practically impossible.

Unattended facial application is, in addition to the complications introduced by fixation to rugged areas and the need to adapt to the shapes of different patients, specific due to its greater need for protection against burns and other side effects. Although the face heals more easily than other areas of the body, it is also more exposed, leading to much higher requirements for treatment downtime. Another important aspect of a facial procedure is that the face houses the most important human senses, the function of which should not be compromised during the treatment. Above all, eye safety must be ensured throughout the treatment.

The current aesthetic market offers traditional manually controlled radiofrequency or light devices that allow heating of facial tissue to a target temperature in the range of 40 °C - 100 °C or unattended LED facial masks whose operation is based on light effects (phototherapy ) instead of thermal effects. These masks are predominantly intended for home use and do not pose a risk to patients from burns, overheating, or overtreatment. Variability in the facial shapes of individual patients does not represent a problem for these masks, as the energy delivered and temperatures achieved are so low that the risk of thermal tissue damage is minimized and there is no need for homogeneous treatment. Furthermore, due to low temperatures, it is not important for such devices to maintain the predetermined distance between individual diodes and the patient's skin, and the shape of the masks is only a very rough representation of the human face. But their use is very limited by low energy and minimal or no thermal effect and therefore they are considered a preventive tool for daily use rather than an in-office skin rejuvenation method with immediate effect.

Nowadays, the aesthetic market feels the needs of the combination of heating treatment performed by electromagnetic energy delivered to the epidermis, dermis, hypodermis or adipose tissue with the secondary energy that provides muscle contraction or muscle stimulation in the field of improvement of the visual appearance of the patient. However, none of the actual devices are adapted to treat irregular areas such as the face. Additionally, commercially available devices are typically portable devices that must be operated by the medical professional throughout the treatment.

Therefore, it is necessary to improve medical devices that provide more than one treatment energy (e.g., electromagnetic energy and electric current), so that both energies can be delivered through different active elements or the same active element (e.g. , electrode). Additionally, the applicator or pad of the device must be connected to the patient, allowing unattended treatment of the patient, and the applicator or pad must be made of flexible material that allows sufficient contact with the uneven treatment area of the part of the device. patient's body.

SUMMARY OF THE INVENTION

In order to enable well-defined unattended treatment of irregular and bumpy areas of a patient (e.g., facial area) while preserving safety, minimally invasive electromagnetic energy delivery methods and devices have been proposed. invasive through one or more active elements.

Patient can include skin and a body part, where a body part can refer to an area of the body.

The desired effect of improving the patient's visual appearance may include heating the tissue (e.g., skin) in the range of 40°C to 50°C, coagulation of the tissue at temperatures of 40°C to 80°C, or ablation. tissue at temperatures from 60 °C to 100 °C. Various patients and skin conditions may require different treatment approaches: higher temperatures allow for better results with fewer sessions, but require longer healing times, while lower temperatures allow for treatment with no downtime, but with results. limited within more sessions. Another effect of heating can lead to a decrease in the number of fat cells.

Another desired effect may be muscle contraction that causes muscle stimulation (e.g., strengthening or toning) to improve the patient's visual appearance.

An agreement has been proposed for contact or non-contact therapy.

For contact therapy, the proposed device comprises at least one electromagnetic energy generator within a main unit that generates an electromagnetic energy that is delivered to the treatment area through at least one active element attached to the skin. At least one active element may be embedded in a pad made of flexible material that conforms to the shape of the rough surface. A bottom portion of the pad may include an adhesive layer that allows the active elements to adhere to the treatment area and maintain the necessary contact with the tissue. Furthermore, the product may employ a safety system capable of adjusting one or more therapeutic parameters based on the measured values of at least one sensor, for example, thermal sensors or impedance measurement sensors capable of measuring the quality of contact with the tissue. treaty.

For non-contact therapy, the proposed device comprises at least one electromagnetic energy generator within a main unit that generates an electromagnetic energy that is delivered to the treatment area through at least one active element located at a defined distance from the tissue at treat. A distance from at least one active element of the treatment area can be controlled before, throughout the treatment or after the treatment. Furthermore, the device may employ a safety system capable of adjusting one or more therapy parameters based on the measured values of at least one sensor, for example, one or more distance sensors. The energy can be supplied by one or more static active elements or by moving one or more active elements throughout the entire treatment area, for example, through a built-in automatic movement system, for example, an integrated scanner. Treatment areas can be established using a laser sight: the operator can mark the area to be treated before treatment.

The active element can supply energy across its entire surface or through a so-called fractional arrangement when the active part includes an array formed by points of defined size. These points may be separated by inactive (and therefore untreated) areas that allow for faster healing of the tissue. The surface of the points can constitute from 1% to 99% of the area of the active element.

Electromagnetic energy can be generated mainly by a laser, laser diode module, LED, flash lamp or incandescent bulb or by a radio frequency generator to cause warming of the patient. Furthermore, an acoustic energy or electrical or electromagnetic energy, which does not heat the patient, can be delivered simultaneously, alternatively or in superposition with the primary electromagnetic energy.

The active element can supply more than one energy simultaneously (at the same time), in a successive or superimposed manner.

For example, the active element can supply a radio frequency energy and subsequently an electrical energy n (electric current). In another example, the active element can deliver the radio frequency energy and the electrical energy at the same time.

Furthermore, the device can be configured to supply the electromagnetic field by at least one active element and simultaneously (at the same time) to supply, for example, electrical energy by a different element.

Therefore, the proposed methods and devices can lead to proper skin rejuvenation, wrinkle removal, skin tightening and lifting, cellulite and fat reduction, pigmented lesion treatment, tattoo removal, tissue coagulation and ablation. soft, reduction of vascular injuries, etc. of irregular areas without causing further damage to important parts of the patient's body, for example, nerves or internal organs. The proposed method and devices can lead to a reduction of adipose tissue, for example, by lipolysis or apoptosis of fat cells.

Furthermore, the proposed methods and devices can lead to tissue rejuvenation, for example, muscle strengthening or muscle toning through muscle contraction caused by electrical or electromagnetic energy.

BRIEF DESCRIPTION OF THE DRAWINGS

Fig. 1 shows a block diagram of a contact therapy apparatus.

Fig. 2 is an illustration of an apparatus for contact therapy.

Fig. 3 represents the shapes and design of the pads.

Fig. 4 represents a side view of the pad intended for contact therapy.

Fig. 5 shows a variant of power supply by switching multiple active elements.

Fig. 6 shows a block diagram of a device for non-contact therapy.

Fig. 7 is an illustration of an apparatus for non-contact therapy.

Fig. 8A is an illustration of the framed grated electrode.

Fig. 8B is an illustration of another framed grated electrode.

Fig. 8C is an illustration of grated electrode framed with conductive thinning lines.

Figure 8D is an illustration of grated electrode without frame.

Fig. 9 is an illustration of the applicator from the front.

DETAILED DESCRIPTION

The methods and devices presented can be used for the stimulation and/or treatment of a tissue, including, but not limited to, skin, epidermis, dermis, hypodermis or muscles. The proposed apparatus is designed for minimal or non-invasive treatment of one or more tissue areas to enable well-defined unattended treatment of irregular and rough areas (e.g. facial area) by supplying electromagnetic energy through one or several active elements without causing further damage to important parts of the patient's body. for example, nerves or internal organs.

Additionally, the methods and devices presented can be used to stimulate body parts or body areas such as head, neck, bra fat, love handles, torso, back, abdomen, buttocks, thighs, calves, legs, arms, forearms, hands, fingers, or body cavities (e.g., vagina, anus, mouth, inner ear, etc.).

The proposed methods and devices may include various protocols to improve visual appearance, which may be pre-programmed in the control unit (for example, CPU which may include a flexible circuit or a printed circuit board and may include a microprocessor or memory to control the device)).

The desired effect may include tissue (e.g. skin) heating (thermal therapy) in the range of 37.5°C to 65°C or in the range of 38°C to 60°C or in the range of 39°C at 55 °C or in the range of 40 °C to 50 °C, tissue coagulation at temperatures in the range of 37.5 °C to 95 °C or in the range of 38 °C to 90 °C or in the range of 39 °C to 85 °C or between 40 °C and 80 °C or tissue ablation at temperatures between 50 °C and 130 °C or between 55 °C and 120 °C or between 60 °C and 110 °C or between 60 °C and 100 °C. The device can be operated in contact or non-contact methods. For contact therapy, a target skin temperature may typically be within the range of 37.5°C to 95°C or in the range of 38°C to 90°C or in the range of 39°C to 85°C or in the range of 40 °C to 80 °C, while for non-contact therapy a target skin temperature can be in the range of 37.5 °C to 130 °C or in the range of 38 °C to 120 °C or in the range of 39 °C to 110 °C or in the range of 40 °C to 100 °C. The temperature within the range of 37.5 °C to 130 °C or in the range of 38 °C to 120 °C or in the range of 39 °C to 110 °C or in the range of 40 °C to 100 ° C can lead to the stimulation of fibroblasts and the formation of connective tissue, for example, collagen, elastin, hyaluronic acid, etc. Depending on the target temperature, controlled tissue damage is triggered, physiological repair processes are initiated and new tissue is formed. Temperatures within the range of 37.5 °C to 130 °C or in the range of 38 °C to 120 °C or in the range of 39 °C to 110 °C or in the range of 5 40 °C to 100 °C They can cause changes in adipose tissue. During the process of apoptosis caused by high temperatures, fat cells are separated into apoptotic bodies and further eliminated through the process of phagocytosis. During a process called necrosis, fat cells rupture due to high temperatures, and their contents are released into an extracellular matrix.

Both processes can lead to a reduction in fat layers that allow for facial reshaping. Removing fat from the face can be beneficial, for example, in areas such as the underbelly or cheeks.

Another desired effect may include tissue rejuvenation, for example muscle strengthening through muscle contraction caused by electrical or electromagnetic energy, which does not heat the patient, or muscle relaxation caused by a pressure massage. The combined effect of muscle contractions through electrical energy and heating of tissues (e.g. skin) by electromagnetic field according to the description can lead to a significant improvement of visual appearance.

Fig. 1 and Fig. 2 are discussed together. Fig. 1 shows a block diagram of a contact therapy apparatus 1. Fig. 2 is an illustration of a contact therapy apparatus 1. The contact therapy apparatus 1 may comprise two main blocks: the unit main 2 and pad 4. Additionally, apparatus 1 may comprise interconnection block 3 or neutral electrode 7. However, the components of interconnection block 3 can be implemented in the main unit 2.

The main unit 2 may include one or more generators: a primary electromagnetic generator 6 that can preferably supply radio frequency energy in the range of 10 kHz to 300 GHz or 300 kHz to 10 GHz or 400 kHz to 6 GHz, or in the range of 100 kHz to 550 MHz or 250 kHz at 500 MHz or from 350 kHz to 100 MHz or from 400 kHz to 80 MHz, a secondary generator 9 that can also supply electromagnetic energy, which does not heat the patient, or supply electric current in the range of 1 Hz to 10 MHz or 5 Hz to 5 MHz or in the range of 10 Hz to 1 MHz and/or an ultrasound emitter 10 which can also supply acoustic energy with a frequency in the range from 20 kHz to 25 GHz or 20 kHz to 1 GHz or 50 kHz to 250 MHz or 100 kHz to 100 MHz. Additionally, the frequency of the ultrasound energy can be in the range of 20 kHz to 80 MHz or kHz to 50 MHz or 150 kHz to 20 MHz.

The output power of the radio frequency energy may be less than or equal to 450, 300, 250 or 220 W. In addition, the radio frequency energy at the output of the primary electromagnetic generator 6 (for example, radio frequency generator) may be in the range from 0.1 W to 400 W, or in the range from 0.5 W to 300 W or in the range from 1 W to 200 W or in the range from 10 W to 150 W. Radio frequency energy can be applied in or near the ISM bands of 6.78 MHz, 13.56 MHz, 27.12 MHz, 40.68 MHz, 433.92 MHz, 915 MHz, 2.45 GHz and 5.8 GHz.

The main unit 2 may further comprise a human-machine interface 8 represented by a screen, buttons, a keyboard, a touch panel, a touch panel or other control members that allow the operator to check and adjust the therapy and other parameters of the device. For example, it may be possible to set the power, treatment time or other treatment parameters of each generator (gprimary electromagnetic generator 6, secondary generator 9 and ultrasound emitter 10) independently . The human-machine interface 8 may be connected to the CPU 11. The power source 5 located in the main unit 2 may include a transformer, a disposable battery, a rechargeable battery, a power plug or a standard power cord. The output power of the power supply 5 may be in the range of 10 W to 600 W, or in the range of 50 W to 500 W, or in the range of 80 W to 450 W.

The interconnection block 3 can serve as a communication channel between the main unit 2 and the platform 4. It can be represented by a simple device containing basic indicators 17 and mechanisms for therapy control. The indicators 17 can be implemented through the display, LED, acoustic signals, vibrations or other forms capable of providing adequate warning to an operator and/or the patient. The indicators 17 may indicate the actual patient temperature, contact information or other sensor measurements, as well as the status of a switching process between the active elements, the quality of contact with the treated tissue, the actual treatment parameters, ongoing treatment, etc. Indicators 17 can be configured to warn the operator in case of suspicious therapy behavior, for example, temperature out of range, inappropriate contact with the treated tissue, automatically adjusted parameters, etc. Interconnect Block 3 can be used as an additional safety feature for heat sensitive patients. It may contain the 16 emergency stop button so that the patient can stop the therapy immediately at any time during the treatment. The switching circuits 14 may be responsible for switching between active elements or for regulating the power supply of the primary electromagnetic generator 6, the secondary generator 9 or the ultrasound emitter 10. The switching speed between active elements 13 may depend on the amount of power supplied, the pulse length, etc., and/or the speed of the switching circuits 14 and CPU 11. The switching circuit 14 may include a switch. relay, transistor (bipolar, PNP, NPN, FET, JFET, MOSFET) thyristor, diode or optomechanical switch or any other suitable switch known in the state of the art. The switching circuit in connection with the CPU can control the switching between the primary electromagnetic energy generated by the primary electromagnetic generator 6 and the secondary energy generated by the secondary generator 9 in at least one active element.

Furthermore, the interconnection block 3 may contain the primary electromagnetic generator 6, the secondary generator 9 or the ultrasound emitter 10 or only one of them or any combination thereof.

The CPU 11 controls the primary electromagnetic generator 6 in such a way that the primary electromagnetic energy can be supplied in a continuous mode (CM) or a pulse mode to at least one active element, with a fluence in the range of 10 mJ/cm² at 50 kJ/cm² or in the range of 100 mJ/cm² at 10 kJ/cm² or in the range of 0.5 J/cm² at 1 kJ/cm². Electromagnetic energy can be generated mainly by a laser, laser diode module, LED, flash lamp or incandescent bulb or by a radio frequency generator to cause warming of the patient. CM mode can operate for a time interval in the range of 0.05 s to 60 min or in the range of 0.1 s to 45 min or in the range of 0.2 s to 30 min. The pulse duration of the power delivery operated in the pulse regime may be in the range of 0.1 ms to 10 s or in the range of 0.2 ms to 7 s or in the range of 0.5 ms to 5 s. The primary electromagnetic generator 6 in the pulse regime can be operated by the CPU 11 in a single shot mode or in a repeat mode. The repeat mode frequency may be in the range of 0.05 to 10,000 Hz or in the range of 0.1 to 5000 Hz or in the range of 0.3 to 2000 Hz or in the range of 0.5 to 1000 Hz. Alternatively, the frequency of the repeat mode repeat mode can be in the range of 0.1 kHz to 200 MHz or in the range of 0.5 kHz to 150 MHz or in the range of 0.5 kHz to 150 MHz or in the range of 0.8 kHz to 100 MHz or in the range from 1 kHz to 80 MHz. Single shot mode may mean the generation of a single electromagnetic pulse of specific parameters (e.g. intensity, duration, etc.) for delivery to a single treatment area. Repetition mode may mean the generation of electromagnetic pulses, which may have specific parameters (e.g. intensity, duration, etc.), with a repetition rate of the frequency mentioned above for delivery to a single treatment area. The CPU 11 may provide treatment control, such as stabilization of treatment parameters, including treatment time, power, duty cycle, time period regulating switching between multiple active elements, device temperature 1 and the temperature of the primary electromagnetic generator 6 and the secondary generator 9 or the ultrasonic emitter 10. The CPU 11 can drive and provide information from the switching circuits 14. The CPU 11 may also receive and provide information from sensors located on or within the pad 4 or any part of the device 1. The CPU 11 may include a flexible circuit or a printed circuit board and may include a microprocessor or memory to control the device.

The CPU 11 can control the secondary generator 9 in such a way that the secondary energy (for example, electric current or magnetic field) can be supplied in continuous mode (CM) or in pulse mode to at least one active element, with a fluence in the range of 10 mJ/cm² at 50 kJ/cm² or in the range of 100 mJ/cm² at 10 kJ/cm²or in the range of 0.5 kJ/cm² at 1 kJ/cm² on the surface of at least one active element. Application of secondary energy to the patient's treatment area may cause the patient's muscle contractions. CM mode can operate for a time interval in the range of 0.05 s to 60 min or in the range of 0.1 s to 45 min or in the range of 0.2 s to 30 min. The pulse duration of the secondary energy delivery operated in the pulse regime may be in the range of 0.1 ps to 10 s or in the range of 0.2 ps to 1 s or in the range of 0.5 ps to 500 ms. The secondary generator 9 in the pulse regime can be operated by the CPU 11 in a single shot mode or in a repeat mode. The repeat mode frequency can be in the range of 0.1 to 12,000 Hz or in the range of 0.1 to 8000 Hz or in the range of 0.1 to 5000 Hz or in the range of 0.5 to 1000 Hz.

The proposed device may allow the CPU 11 to control the process at the same time.

be a multichannel device treatment of more than one area

Alternatively, the interconnection block 3 may not be part of the device 1, and the CPU 11, switching circuits 14, indicators 17 and emergency stop 16 may be part of the main unit 2 or pad 4. Furthermore, some of the indicators 11 of the CPU 11, the switching circuits 14, the indicators 17 and the emergency stop 16 may be part of the main unit 2 and some of them are part of the pad 4, for example, the CPU 11, switching circuits 14 and emergency stop 16 may be part of main unit 2 and indicators 17 may be part of pad 4.

Pad 4 represents the part of the device that can be in contact with the patient's skin during therapy. The pads 4 can be made of flexible substrate material, for example, polymer-based material, polyimide (PI) films, Teflon, epoxy, polyethylene terephthalate (PET), polyamide foam or PE with an additional adhesive layer on the bottom, for example, a hypoallergenic adhesive gel or adhesive tape that can be bacteriostatic, non-irritating or water-soluble. The substrate may also be a silicone-based substrate. The substrate may also be made of a fabric, for example nonwoven fabric. The adhesive layer may have the impedance for a current at a frequency of 500 kHz in the range of 1 to 150 Ω or in the range of 5 to 130 Ω or in the range of 10 to 100 Ω, and the impedance for a current at a frequency of 100 Hz or less is three times or more the impedance for a current at a frequency of 500 kHz. The adhesive hydrogel may be made of a polymer matrix or mixture containing water, a polyhydric alcohol, a polyvinylpyrrolidone, a polyisocyanate component, a polyol component or having a methylenediphenyl structure in the main chain. Additionally, a conductive adhesive can be augmented with metallic fillers, such as silver, gold, copper, aluminum, platinum or titanium or graphite that constitute 1 to 90% or 2 to 80% or 5 to 70% of the adhesive. The adhesive layer can be covered with ST-gel(R) or Tensive conductive adhesive gel.^!R) which is applied to the body to reduce its impedance, thus facilitating the delivery of an electric shock.

The adhesive layer under the pad 4 may mean that the adhesive layer is between the surface of the pad facing the patient and the patient's body. The adhesive layer may have impedance 1.1 times, 2 times, 4 times or up to 10 times greater than the impedance of the patient's skin under pad 4. One definition of skin impedance may be that it is a portion of the total impedance, measured between two equipotential surfaces in contact with the epidermis, that is inversely proportional to the area of the electrode, when the path of internal current flow is held constant. . Data applicable to this definition would conveniently be recorded as admittance per unit area to facilitate application to other geometries. The impedance of the adhesive layer can be tuned using the same experimental setup used to measure skin impedance. The impedance of the adhesive layer may be greater than the impedance of the skin by a factor in the range of 1.1 to 20 times or 1.2 to 15 times or 1.3 to 10 times.

The impedance of the adhesive layer may have different values for different types of energy delivered to the patient, for example, the impedance may be different for radiofrequency and for the administration of electrical current. The impedance of the hydrogel may be in the range of 100 to 2000 Ohm or in the range of 150 to 1800 Ohm or 200 to 1500 Ohm or 300 to 1200 Ohm in case of supplying the electrical current (for example, during electrotherapy).

Pad 4 may also have a sticker on the top of the pad. The top is the opposite site of the bottom (the side where the adhesive layer can be deposited) or in other words, the top is the side of the pad that is facing the patient during treatment. The label may have a bottom side and a top side, wherein the bottom side of the label may comprise an adhesive layer and the top side of the label may comprise a non-stick layer (e.g., polyimide (PI) films, Teflon , epoxy, polyethylene terephthalate (PET), polyamide or PE foam).

The sticker may be the same shape as pad 4 or may have an additional overlay on the pad. The sticker may be attached to the pad in such a way that the adhesive layer of the bottom of the label faces the top of the pad 4. The top of the sticker facing away from the pad 4 may be made of a non-stick layer. The size of the label with additional overlap may exceed the pad in the range of 0.1 to 10 cm, or in the range of 0.1 to Ί cm, or in the range of 0.2 to 5 cm, or in the range of 0.2 to 3 cm . This overlay can also undertake the adhesive layer and can be used to form additional and more suitable contact of the pad with the patient.

Alternatively, the pad 4 may comprise at least one suction opening, for example, small cavities or indentations adjacent to active elements or the active element may be embedded within a cavity. The suction opening can be connected via a connecting pipe to a pump which can be part of the main unit 2. When the suction opening comes into contact with the skin, the air sucked from the suction opening flows into the connecting tube and the pump and the skin can be slightly sucked into the suction opening. Therefore, by applying a vacuum, adhesion of the pad 4 can be provided. Furthermore, the pad 4 can comprise the adhesive layer and suction openings for a combined stronger adhesion.

In addition to vacuum (negative pressure), the pump can also provide positive pressure by pumping fluid to the suction opening. Positive pressure is the pressure higher than atmospheric pressure and negative pressure or vacuum is lower than atmospheric pressure. Atmospheric pressure is a pressure of the air in the room during therapy.

Pressure (positive or negative) can be applied to the treatment area in pulses providing a massage treatment. The massage treatment may be provided by one or more suction openings that change the pressure value to the patient's soft tissue in that the suction opening applies a different pressure to the patient's tissue. Additionally, the suction openings can create a pressure gradient in the soft tissue without touching the skin. Such pressure gradients can be directed to the soft tissue layer, below the surface of the skin and/or to different soft tissue structures.

Massage accelerates and improves treatment therapy by electromagnetic energy, electrical energy or electromagnetic energy that does not heat the patient, improves blood and/or lymphatic circulation, angioedema, erythema effect, accelerates the elimination of fat, accelerates metabolism, accelerates elastogenesis and/or neocollagenesis.

Each suction opening may provide pressure by a suction mechanism, air flow or gas flow, liquid flow, pressure provided by an object included in the suction opening (e.g. massage object, pressure cells, etc. ) and/or in other ways.

The pressure value applied on the patient's tissue means that a suction opening that provides a massage effect applies positive, negative and/or sequentially changing positive and negative pressure on the tissue structures of the treated and/or adjacent patient and/or creates a pressure gradient below the surface of the patient's tissue.

Massage applied to improve body fluid flow (e.g., lymphatic drainage) and/or relax tissue in the superficial soft tissue layers may be applied with lower pressure than during massage of the deeper soft tissue layers. . Said positive or negative pressure compared to atmospheric pressure may be in the range of 10 Pa to 30,000 Pa, or in the range of 100 Pa to 20,000 Pa or in the range of 0.5 kPa to 19 kPa or in a range of 1 kPa to 15 kPa.

Massage applied to improve body fluid flow and/or tissue relaxation in the deeper layers of soft tissue can be applied with higher pressure. Said positive or negative pressure may be in the range of 12 kPa to 400 kPa or 15 kPa to 300 kPa or 20 kPa to 200 kPa. An uncomfortable sensation of too high applied pressure can be used to establish a pressure threshold according to the patient's individual feedback.

Negative pressure can stimulate body fluid flow and/or relaxation of deep soft tissue layers (0.5 cm to non-limited depth in soft tissue) and/or soft tissue layers near the patient's surface (0.1 mm to 0.5 cm). In order to increase the effectiveness of the massage, negative pressure treatment followed by positive pressure treatment can be used.

A number of suction openings that change pressure values in the soft tissue of the patient in a pad 4 may be between 1 to 100 or between 1 to 80 or 1 to 40 or between 1 to 10.

The sizes and/or shapes of the suction openings may be different depending on the area treated. A suction opening can cover an area on the patient's surface between 0.1 mm² to 1 cm² or between 0.1 mm² at 50mm² or between 0.1 mm² at 40mm² or between 0.1 mm² at 20mm². Another suction opening can cover an area on the patient's surface between 1 cm² at 1m² or between 1 cm² at 100cm² or between 1 cm²at 50cm² or between 1 cm² at 4 0 cm².

Several suction openings can operate simultaneously or the switching between them can be in intervals between 1 ms to 10 s or in intervals between 10 ms to 5 s or in intervals between 0.5 s to 2 s.

The suction openings for providing a massage effect may be guided according to one or more predetermined massage profiles included in one or more treatment protocols. The massage profile can be selected by the operator and/or by a CPU with respect to the patient's condition. For example, a patient with lymphedema may require a different level of compression profile and applied pressure than a patient with a healed leg ulcer.

The pressure applied by one or more suction openings can be applied gradually, preferably in the positive direction of lymphatic flow and/or blood flow in the veins. According to specific treatment protocols, pressure can be gradually applied in a direction opposite or different from ordinary lymphatic flow. The pressure values applied during treatment may vary depending on the treatment protocol.

A pressure gradient may arise between the individual suction openings. The examples of gradients described are not limited to this method and/or device. The pressure gradient setting between at least two preceding and subsequent suction openings can be: 0%, i.e. the pressure applied by the suction openings is the same (for example, the pressure in all suction openings of the pad is the same);

%, that is, the pressure applied between a previous suction opening and a subsequent one decreases and/or increases with a slope of 1% (for example, the pressure at the first suction opening is 5 kPa and the pressure at the successive aspiration is 4.95 kPa);

%, that is, the pressure decreases or increases with a slope of 2%. The pressure gradient between two suction openings can be in the range of 0% to 100%, where 100% means that a suction opening is not active and/or does not apply any pressure to the patient's soft tissue.

A treatment protocol that controls the application of the pressure gradient between a previous and a subsequent suction opening may be in the range between 0.1% and 95%, or between 0.1% and 70%, or between 1%. and 50%.

The suction opening may also comprise an impacting massage object fed by a piston, a massage object operated by filling or sucking liquid or air from the space volume by an inlet/outlet valve, or a massage object fed by an element that creates a field. electric, magnetic field or electromagnetic field. Additionally, massage can be provided by the impact of multiple massage objects. The multiple massage objects may have the same or different size, shape, weight or may be created from the same or different materials. Massage objects can be accelerated by flowing air or liquid (through the valve) or by an electric, magnetic or electromagnetic field. The trajectory of the massage objects can be random, circular, linear and/or the massage objects can rotate around one or more axes, and/or can make other types of movements in the volume of space.

The massage unit may also comprise a membrane on the side facing the patient which may be accelerated by an electric, magnetic, electromagnetic field or by changing the pressure value in the volume of space between the chamber wall and the membrane. This membrane can act as the massage object.

During treatment, it may be advisable to use a combination of pads with an adhesive layer and pads with suction openings. In that case, at least one pad used during treatment may comprise an adhesive layer and at least one additional pad used during treatment may include a suction opening. For example, the pad with adhesive layer may be suitable for the treatment of more uneven areas, for example, periorbital area, and the pad with suction openings for the treatment of smoother areas, for example, cheeks.

The advantage of the device in which the fixation of the pads can be provided by an adhesion layer or by a suction opening or their combination is that there is no need for any additional gripping system that is necessary to hold the pads in the area of treatment during treatment, for example, a band or felt, which may cause patient discomfort.

However, in another embodiment, it is possible to attach the flexible pads 4 to the face with at least one band or felt which may be made of an elastic material and therefore adjusted for an individual face. In that case, the flexible pads, which may not have the adhesive layer or suction opening, are placed on the patient's treatment area and their position is secured by a band or felt to prevent deviation of the pads from the areas. of treatment. Alternatively, the band can be replaced by an elastic mask that covers 5% to 100% or 30% to 99% or 40% to 95% or 50% to 90% of the face and can serve to secure the pads. flexible in treatment areas. Additionally, it may be possible to use the combination of the pad with the adhesive layer or suction opening and the headband, felt or mask to ensure a strong fixation of the pads on the treatment areas.

Furthermore, the fastening mechanism may be in the form of a textile or a garment that can be mounted on the body part of a user. In use of the device, one surface of the electrode or electrode pad 4 is located along an inner surface of the garment, while the opposite surface of the electrode or electrode pad 4 is in contact with the skin of the user, preferably via a skin electrode hydrogel interface.

The garment may be fastened to secure the garment to or around a wearer's body part, for example, by hook and loop closure, button, buckle, bolt, strap or drawstring, magnetically guided locking system, or fastening band. , and the garment can be made from flexible materials or fabrics that adapt to the shape of the wearer's body or limb. The electrode pad 4 may be configured in the same way to attach to the inner surface of the garment. The garment is preferably made of breathable materials. Non-limiting examples of such materials are soft neoprene, nylon, polyurethane, polyester, polyamide, polypropylene, silicone, cotton or any other material that is soft and flexible. All of the materials named could be used as non-woven fabrics, single-use fabrics or laminated structures.

The garment and the pad can be of a modular system, which means that the module or element of the device (pad, garment) and/or system is designed separately and independently of the rest of the modules or elements, at the same time that they are compatible between Yeah.

The pad 4 may be designed to be fixed or in contact with the garment, thus being carried by the garment in a stationary or fixed condition, such that the pads are arranged in fixed positions of the garment. The garment ensures the correct adhesion or arrangement of the pad to the user's skin. In use of the device, the surface of one or more active elements that are not in contact with the garment is in contact with the patient's skin, preferably by means of a hydrogel layer that acts as a pad-skin interface. Therefore, the active elements included in the pad are in contact with the patient's skin.

The optimal placement of the pad on the patient's body part, and therefore the garment wearing the pad that has the active elements, is determined by a technician or clinician assisting the patient.

Additionally, the garment may comprise more than one treatment pad or a garment comprising one or more treatment pads during a session.

The pad 4 may contain at least one active element 13 capable of supplying energy from the primary electromagnetic generator 6 or the secondary generator 9 or the ultrasound emitter 10. The active element can be in the form of an electrode, an optical element, an acoustic window , an ultrasound emitter or other energy supply elements known in the art. The electrode may be a radio frequency (RF) electrode. The RF electrode may be a dielectric electrode coated with insulating material (e.g., dielectric). The RF electrode can be monopolar, bipolar, unipolar or multipolar. The bipolar arrangement may consist of electrodes that alternate between active and return function and where the thermal gradient under the electrodes is almost the same during treatment. Bipolar electrodes can form circular or ellipsoidal shapes, where the electrodes are concentric with each other. However, a group of bipolar electrode systems can also be used. A unipolar electrode or one or more multipolar electrodes can also be used. The system can alternatively use monopolar electrodes, where the so-called return electrode has a larger area than the so-called active electrode. Therefore, the thermal gradient under the active electrode is greater than under the return electrode. The active electrode may be part of the pad and the passive electrode having a larger surface area may be located at least 5 cm, 10 cm, or 20 cm from the pad. A neutral electrode can be used as a passive electrode. The neutral electrode may be on the opposite side of the patient's body that the pad is connected to. A unipolar electrode can also be used optionally. During unipolar power delivery there is one electrode, no neutral electrode, and a large RF field emitted in an omnidirectional field around a single electrode. Capacitive and/or resistive electrodes can be used. The radiofrequency energy can provide an energy flux on the surface of the active element 13 or on the surface of the treated tissue (e.g., skin) in the range of 0.001 W/cm² at 1500 W/cm²or 0.01 W/cm² at 1000 W/cm² or 0.5 W/cm² at 500 W/cm² or 0.5 W/cm² at 100 W/cm² or 1 W/cm² at 50 W/cm². The energy flow on the surface of the active element 13 can be calculated from the size of the active element 13 and its energy output value. The energy flux on the surface of the treated tissue can be calculated from the size of the treated tissue exactly below the active element 13 and its input value of the energy provided by the active element 13. Additionally, the RF electrode placed on pad 4 can act as an acoustic window for ultrasound energy.

The active element 13 may provide secondary energy to the secondary generator 9 in the form of an electric current or magnetic field. By applying the secondary energy to the treated area of the patient's body, stimulation of the muscle 5 fibers can be achieved and therefore increased muscle tone, muscle strengthening, restoration of muscle sensation, relaxation of the muscles and/or stretch the muscles.

The proposed device can provide electrotherapy in case the secondary energy generated by the active element 13 (for example, a radiofrequency electrode or simply called an electrode) is the electric current. The main effects of electrotherapy are: analgesic, muscle relaxation, iontophoresis, antiedematous effect or muscle stimulation causing a contraction of the muscle fiber. Each of these effects can be achieved by one or more types of electrotherapy: galvanic current, pulse direct current, and alternating current.

Galvanic (or direct) current is a current that can have constant electric current and/or the absolute value of the electric current is at all times greater than 0. It can be mainly used for iontophoresis, or its trophic stimulation effect is used (hyperemic). In the present invention this current can often be replaced by intermittent galvanic current. In addition, the galvanic component may be about 95%, but due to the interruption of the originally continuous intensity, the frequency may reach 512 kHz or 5 - 10 kHz or 5-9 kHz or 5-8 kHz.

Pulse direct current (DC) is of variable intensity but only one polarity. The basic shape of the pulse may vary. It includes, for example, diadynamic, rectangular, triangular and exponential pulse of one polarity. Depending on the frequency and intensity used, it can have a stimulating, tropic, analgesic, muscle relaxation, iontophoresis, at least partial muscle contraction and anti-edematous and/or other effect.

Alternating current (AC or biphasic) where the basic shape of the pulse can vary: rectangular, triangular, sinusoidal harmonic, exponential and/or other shapes and/or combination of those mentioned above. It can be alternating, symmetrical and/or asymmetrical. The use of alternating currents in contact electrotherapy involves much less stress on the tissue beneath the electrode. For this type of currents, the capacitive component of the skin's resistance is involved, and because of that these currents are very well tolerated by patients.

AC therapies can be differentiated into five subtypes:

TEES, classical interference (four poles), bipolar interference, isoplanar interference and field some specific variants period core, dipole vector form. There are also electrotherapy energy and energy, etc.

Due to interference electrotherapy, different nerves and tissue structures by medium frequency can be stimulated in a range of 500 Hz to 12 kHz or in a range of 500 Hz to 8 kHz, or 500 Hz to 6 kHz, creating pulse envelopes with frequencies for stimulation of nerves and tissues, e.g. sympathetic nerves (0.1-5 Hz), parasympathetic nerves (10-150 Hz), motor nerves (10-50 Hz), smooth muscle (0.1-10 Hz) , sensory nerves (90-100 Hz) nociceptive fibers (90-150 Hz).

Electrotherapy can provide stimulation with frequency currents in the range of 0.1 Hz to 12 kHz or in the range of 0.1 Hz to 8 kHz or in the range of 0.1 Hz to 6 kHz.

Muscle fiber stimulation by electrotherapy may be important during and/or as part of RF treatment. Muscle stimulation increases blood flow and lymphatic circulation. It may improve the removal of treated cells and/or prevent the creation of hot spots. In addition, the internal massage stimulation of adjacent tissues improves tissue homogeneity and dispersion of the delivered energy. Muscle fiber stimulation by electrotherapy can cause muscle contractions, which can lead to improvement of a patient's visual appearance through muscle firming and strengthening. Another beneficial effect is, for example, during fat removal with RF therapy. RF therapy can change the structure of fatty tissue. Stimulation of the muscle fiber can provide internal massage, which can be more effective than classic massage for the obese patient.

Muscle stimulation can be provided, for example, by intermittent direct currents, alternating currents (medium frequency current and TENS), faradic current as multiple stimulation method and/or others.

The frequency of the currents can be in the range of 0.1 Hz to 1500 Hz or 0.1 to 1000 Hz or 0.1 Hz to 500 Hz or 0.1 to 300 Hz.

The frequency of the current envelope is usually in the range of 0.1 Hz to 500 Hz or 0.1 to 250 Hz or 0.1 Hz to 150 Hz or 0.1 to 140 Hz.

Electrostimulation can be provided in a combined manner where several treatments with various effects can be achieved. As an illustrative example, the electromagnetic energy with electrostimulation can be dosed in trains of pulses of electrical current where the first train of electrostimulation can achieve a different effect than the second or other successive train of stimulation. Therefore, the treatment may provide stimulation of muscle fibers or muscle contractions followed by relaxation, during continuous or pulsed radiofrequency thermal heating provided by the electromagnetic energy provided by the electromagnetic energy generator.

Electrostimulation can be provided by monopolar, unipolar, bipolar or multipolar mode.

The absolute value of voltage between electrotherapy electrodes operated in bipolar, multipolar (electric current flow between more than two electrodes) mode and/or provided to at least one electrotherapy electrode may be in the range between 0.8 V and 10 kV; or in the range between 1 V and 1 kV; or in the range between 1 V and 300 V or in the range between 1 V and 100 V.

The current density of electrotherapy for non-galvanic current can be in the range between 0.1 mA/cm² and 150 mA/cm², or in the range between 0.1 mA/cm² and 100 mA/cm², or in the range between 0.1 mA/cm² and 50 mA/cm², or in the range between 0.1 mA/cm² and 20 mA/cm²; for the galvanic current can preferably be in the range between 0.05 mA/cm² and 3 mA/cm², or in the range between 0.1 mA/cm² and 1 mA/cm², or in the range between 0.01 mA/cm² and 0.5 mA/cm². The current density can be calculated on the surface of the electrode that provides the electrotherapy to the patient.

During electrotherapy, for example bipolar electrotherapy, two or more electrodes may be used. If the polarity of at least one electrode has a non-zero value in an electrode group during bipolar mode, the electrode group must include at least one electrode with opposite polarity value. The absolute values of both electrode polarities may or may not be the same. In the bipolar electrostimulation mode, the stimulating signal passes through the tissue between electrodes with opposite polarities.

The distance between two electrodes operating in bipolar mode can be in the range between 0.1 mm and 4 cm or in the range between 0.2 mm and 3 cm or in the range between 0.5 mm and 2 cm or in the range between 1 mm and 1 cm or in the range of 0.1 cm and 40 cm or in the range between 1 cm and 30 cm, or in the range between 1 cm and 20 cm.

During the monopolar electrotherapy mode, the stimulating signal can be induced by excitation of the action potential by changing the polarity of an electrode which changes the polarization in the nerve fiber and/or neuromuscular plague.

During electrotherapy, bipolar or monopolar electrotherapy is used.

You can use one of the modes or you can combine the mode

Ultrasound emitters can provide focused or unfocused ultrasound energy. Ultrasound energy can be transferred to tissue through an acoustic window. The output power of the ultrasound energy on the surface of the active element 13 may be less than or equal to 20 W or 15 W or 10 W or 5 W. The econ energy can provide an energy flux on the surface of the active element 13 or on the surface of the treated tissue (e.g., skin) in the range of 0.001 W/cm² at 250 W/cm², or in the range of 0.005 W/cm² at 50 W/cm², or in the range of 0.01 W/cm² at 25 W/cm², or in the range of 0.05 W/cm² at 20 W/cm². The treatment depth of ultrasound energy can be in the range of 0.1 mm to 100 mm or 0.2 mm to 50 mm or 0.25 mm to 25 mm or 0.3 mm to 15 mm. At a depth of 5 mm, ultrasound energy can provide an energy flux in the range of 0.01 W/cm² at 20 W/cm²or 0.05 W/cm² at 15 W/cm². An ultrasound beam may have a beam non-uniformity ratio (Rbn) in the range of 0.1 to 20 or from 2 to 15 to 4 to 10. Additionally, an ultrasound beam may have a beam non-uniformity ratio below of 15 or below 10. An ultrasound beam can be divergent, convergent and/or collimated. Ultrasound energy can be transferred to tissue through an acoustic window. It is possible that the RF electrode acts as the acoustic window. Furthermore, the ultrasound emitter 10 may be part of the active element 13, so the ultrasound emitter 10 may be part of the pad 4.

At least some of the active elements 13 may be capable of supplying power from the primary electromagnetic generator 6 or the secondary generator 9 or the ultrasound emitter 10 simultaneously (at the same time) successively or in a superimposed method or in any combination thereof. For example, the active element 13 may be capable of supplying radio frequency energy and electrical current sequentially, which may mean that, first, the active element 13 may provide primary electromagnetic energy generated by the primary electromagnetic generator 6, and subsequently, The active element 13 can provide the secondary energy generated by the secondary generator 9. Thus, the active element 13 can, for example, apply radiofrequency energy to the patient's tissue and then the same active element 13 can apply, for example, electrical current to the patient's tissue.

The pad 4 may further comprise thermal sensors 15 that allow temperature control during therapy, provide feedback to the CPU 11, allow adjustment of the treatment parameters of each active element and provide information to the operator. The thermal sensor 15 may be a contact sensor, a non-contact sensor (for example, an infrared temperature sensor) or an invasive sensor (for example, a thermocouple) for precise measurement of the temperature of deep layers of the skin, for example, epidermis, dermis or hypodermis.

CPU 11 can also use algorithms to calculate the lowest or highest temperatures. A temperature feedback system may monitor the temperature and, based on set or preset limits, alert the operator in a human-perceivable manner, for example, at the human-machine interface 8 or via indicators 17. In a limiting temperature condition, the device can be configured to adjust one or more treatment parameters, for example, output power, switching mode, pulse length, etc. or stop treatment. A human-perceivable alert may be a sound, an alert message displayed on the human-machine interface 8 or indicators 17, or a color change of any part of the interconnect block 3 or pad 4.

The memory 12 may include, for example, information about the type and shape of the pad 4, its remaining useful life, or the therapy time that has already been performed with the pad.

The neutral electrode 7 can ensure adequate distribution of the radiofrequency within the patient's body for monopolar radiofrequency systems. The neutral electrode 7 is attached to the patient's skin before each therapy so that the energy can be distributed between the active element 13 and the neutral electrode 7. In some bipolar or multipolar radiofrequency systems, there is no need to use a neutral electrode: the radiofrequency energy is distributed between multiple active elements 13. The neutral electrode 7 represents an optional block of the apparatus 1, since any type of radio frequency system.

Furthermore, the device 1 may include one or more sensors. The sensor may provide information about at least one physical quantity and its measurement may give rise to feedback that may be displayed by the human-machine interface 8 or the indicators 17. One or more sensors may be used to detect the delivered electromagnetic energy, the impedance of the skin, the resistance of the skin, the temperature of the treated skin, the temperature of the untreated skin, the temperature of at least one layer of the skin , the water content of the device, the phase angle of the supplied or reflected energy, the position of the active elements 13, The position of the interconnecting block 3, the temperature of the cooling medium, the temperature of the primary electromagnetic generator 6 and the secondary generator 9 and the ultrasound emitter 10 or contact with the skin. The sensor can be a thermal, acoustic, vibration, electrical, magnetic, flow, positional, optical, image, pressure, force, energy flow, impedance, current, Hall or proximity sensor. The sensor may be a capacitive displacement sensor, acoustic proximity sensor, gyroscope, accelerometer, magnetometer, infrared camera or thermal imaging camera. The sensor can be invasive or contactless. The sensor may be located on or in the pad 4, in the main unit 2, in the interconnection block 3 or may be part of a thermal sensor 15. A sensor may measure more than one physical quantity. For example, the sensor may include a combination of a gyroscope, an accelerometer, and/or a magnetometer. Additionally, the sensor may measure one or more physical quantities of the treated skin or untreated skin.

A resistance sensor can measure skin resistance, because skin resistance can vary for different patients, as well as humidity: humidity and sweat can influence the resistance and therefore the behavior of the skin. skin in the energy field. Based on the measured skin resistance, the skin impedance can also be calculated.

Information from one or more sensors may be used for the generation of a pathway in a model, for example, a model of the human body displayed on a human-machine interface screen 8. The pathway may illustrate a surface or volume of tissue. already treated, currently treated fabric, fabric to be treated or untreated fabric. A model can display a temperature map of the treated tissue that provides information about the already treated tissue or the untreated tissue.

The sensor can provide information about the location of bones, inflamed tissue or joints. Such types of eyebrows may not be attacked by electromagnetic energy due to the possibility of painful treatment. Bones, joints or inflamed tissue can be detected by any type of sensor, such as an imaging sensor (ultrasound sensor, IR sensor), impedance sensor and the like. A detected presence of these types of tissues can cause general human perceptible signals or disruption of electromagnetic energy generation. Bones can be detected by a change in tissue impedance or by analysis of reflected electromagnetic energy.

The skin of the patient in at least one treatment portion may be pre-cooled to a selected temperature for a selected period, the selected temperature and duration for pre-cooling may be sufficient to cool the skin to at least a temperature selected by below normal body temperature. The skin may be cooled at least to the selected temperature to a depth less than at least one depth for the treatment portions, such that at least one treatment portion is substantially surrounded by cooled skin. Cooling may continue during the energy application, and the duration of the energy application may be greater than the thermal relaxation time of the treatment portions. Cooling can be provided by any known mechanism, including water cooling, spray coolant, the presence of an active solid cooling element (e.g., thermoelectric cooler), or airflow cooling. A cooling element can act as an optical element. Alternatively, the cooling element may be a spacer. Cooling may be provided during, before or after treatment with electromagnetic energy. Cooling before treatment can also provide an environment for sudden thermal shock, while cooling after treatment can provide faster regeneration after thermal shock. The coolant temperature can be in the range of -200°C to 36°C. The temperature of the cooling element during treatment can be in the range of -80°C to 36°C or -70°C to 35°C or -60°C to 34°C. Additionally, when the pad is not in contact with the patient's skin, cryogenic spray cooling, gas flow, or other non-contact cooling techniques can be used. A cooling gel can also be used on the surface of the skin, either in addition to or instead of one of the cooling techniques listed above.

Fig. 3A and Fig. 3B show different shapes and designs of the pad 4 used by an apparatus for contact therapy. The pads 4 comprise at least one active element 13 and may be available in various shapes and designs so that they can cover a variety of different treatment areas and adapt to the individual needs of the patient, for example, annular, semicircular, elliptical, oblong, square, rectangular, trapezoidal, polygonal or shapeless (without shape or regular shape). The shapes and designs of the pad 4 may be shaped to cover at least part of one or more of the periorbital areas, the forehead (including the frown lines), the jaw line, the perioral area (including the marionette, perioral lines, called smoking lines, nasolabial folds, lips and chin), cheeks or subchin, etc. The shape of the pad 4 and the distribution, size and number of active elements 13 may differ depending on the area to be treated, for example, the active elements 13 within the pad 4 may be in one line, two lines, three lines. , four lines or several lines. The pad 4 with active elements 13 can be arranged in various ways, for example, in a line, where the centers of at least two active elements 13 lie on a straight line, while any additional centers of an active element 13 can be on the same or different lines within pad 4.

Additionally, pad 4 can be used to at least partially treat the neck, bra fat, love handles, torso, back, abdomen, buttocks, thighs, calves, legs, arms, forearms, hands, fingers, or body cavities (e.g., vagina, anus, mouth, inner ear, etc.).

The pad 4 may have a rectangular, oblong, square, trapezoidal shape, or in the shape of a convex or concave polygon in which the pad 4 may have at least two different internal angles of the convex or concave polygonal structure. Furthermore, the pad 4 may at least partly form the shape of a conic section (also called a conic), for example, circle, ellipse, parabola or hyperbola. The pad 4 may have at least in part one, two, three, four, five or more curvatures of an arc shape with the curvature k in the range of 0.002 to 10 mm^-1 or in the range of 0.004 to 5 mm^-1 or in the range of 0.005 to 3 mm^-1 or in the range of 0.006 to 2 mm^-1. The pad 4 may have at least one, two, three, four, five or more arcs with curvature k or may have at least two different internal angles of a convex or concave polygonal structure, and may be suitable for the treatment of the chin, the cheeks, the submental area (for example, banana shape 1 4.2), to treat the jaw line, perioral area, marionette lines and nasolabial folds (for example, banana shape 2 4.4), for the treatment of the periorbital area (e.g. horseshoe shape 4.3) or other regions of the face and neck. The banana-shaped pad 4.2 or 4.4 can have a convex-concave shape, which means that one side is convex and the opposite side is concave, which occupies at least 5% to 50% or 10% to 60% or 15%. at 70% or 20% to 90% of a total circumference of the pad 4 seen from above, in which the shortest distance between the end points 4.21a and 4.21b of the banana-shaped pad 4.2 (dashed line in Fig. 3A) is longer than the shortest distance between the end point 4.21a or 4.21b and the midpoint 4.22 of the banana shape (full line on pad 4.2 in Fig. 3A). The horseshoe shape 4.3 seen from above may have the convex-concave shape that occupies at least 15% to 50% or 20% to 60% or 25% to 70% or 30% to 90% of its total circumference. , in which the shortest distance between the end points 4.31a and 4.31b of the horseshoe-shaped pad 4.3 (dashed line in Fig. 3B) is equal to or shorter than the shortest distance between the end point 4.31a or 4.31b and the midpoint 4.32 of the horseshoe shape (full line on pad 4.3 in Fig. 3B). When viewed from above, if the longest possible central curve, which may be convex or concave and whose perpendiculars at a given point have an equidistant distance from the perimeter edges of the pad at each of its points (dotted line on the pad 4.2 in Fig. 3A), intersects the circumference of pad 4, then this point is the end point of the pad, for example, end point 4.21a or 4.21b. The midpoint, for example, 4.22, is then given as the center of the central curve, where the total length of the central curve is given by two end points, for example, 4.21a and 4.21b, so the length of the central curve (dotted line in pad 4.2 in Fig. 3A) from point 4.21a to point 4.22 is the same as the length from point 4.21b to point 4.22. The total length of the central curve can be in the range of 0.1 to 30 cm or in the range of 0.5 to 25 cm or in the range of 1 to 20 cm.

Furthermore, the central curve may have at least in part a circular, elliptical, parabolic, hyperbolic, exponential, convex or concave curve such that the straight line connecting the end point of the pad 4 with the midpoint of the central curve forms a angle alpha with the tangent of the center of the central curve. The alpha angle can be in a range of 0.1° to 179° or in a range of 0.2° to 170° or in a range of 0.5° to 160° or in a range of I^either at 150°.

The pad 4 whose shape has at least two concave arcs with curvature k or has at least two concave interior angles of the polygon structure may be suitable for forehead treatment as the T shape 4.1 in Fig. 3A. The T-shape 4.1 can also be characterized by the arrangement of the active elements 13 where the centers of at least two active elements 13 lie on a straight line and the center of at least one additional element 13 lies on a different line.

The pads can have different sizes with surface areas ranging from 0.1 to 150 cm² or from 0.2 to 125 cm² or from 0.5 to ICO cm² or in the range of 1 to 50 cm². The pad may occupy approximately 1-99% or 1-80% or 1-60% or 1-50% of the face. The number of active elements 13 within a single pad 4 varies from 1 to 100 or from 1 to 80 or from 1 to 60 or from 1 to 40. A thickness at least in a portion of the pad 4 may be in the range of 0.01 to 15 cm or in the range of 0.02 to 10 cm or in the range of 0.05 to 7 cm or in the range of 0.1 to 7 cm.

Furthermore, the pads 4 may have a shape that at least partially replicates the shape of galea aponeurotica, procerus, levatar labii superioris alaeque nasi, nasalis, lavator labii superioris, zygomaticus minor, zygomaticus major, levator angulis oris, risorius, platysma, depressor anguli oris, depressor labii inferioris, occipitofrontalis (front belly), currugator supercilii, orbicularis oculi, buccinator, masseter, orbicularis oris or mentalis muscle when pad 4 is attached to the patient's skin surface.

The pad 4 may be characterized by at least one aspect mentioned above or by a combination of more than one aspect mentioned above or by a combination of all the aspects mentioned above.

The electromagnetic energy generator 6 or the secondary generator 9 within the main case can generate an electromagnetic or secondary energy (for example, electric current) that can be supplied through a conductive cable to at least one active element 13 attached to the skin. , respectively. The active element 13 can supply energy over its entire surface or by means of the so-called fractional arrangement. The active element 13 may comprise an active electrode in a monopolar, unipolar, bipolar or multipolar radiofrequency system. In the monopolar radio frequency system, energy is delivered between an active electrode (active element 13) and a neutral electrode 7 with a much larger surface area. Due to the mutual distance and the difference between the surface area of the active and neutral electrode, the energy is concentrated under the active electrode, allowing it to heat the treated area. In unipolar, bipolar or multipolar radiofrequency system, there is no need for neutral electrode 7. In bipolar and multipolar radiofrequency system, energy is delivered between two and multiple active electrodes with similar surface area, respectively. The distance between these electrodes determines the depth of energy penetration. In the unipolar radiofrequency system, only a single active electrode is incorporated and energy is delivered to the tissue and the environment surrounding the active electrode. The distance between the two closest active elements 13 (for example, the nearest neighboring sides of the electrodes) in a pad 4 may be in the range of 0.1 to 100 mm or in the range of 0.3 to 70 mm or in the range from 0.5 to 60 mm or in the range of 1 to 50 mm.

Fig. 4 represents a side view of pad 4 configured for contact therapy. The pads 4 can be made of flexible substrate material 42 - polyimide (PI) films, Teflon, epoxy or PE foam with an additional adhesive layer 40 on the bottom. They can be of different shapes to allow the operator to choose according to the area to be treated. The active elements 13 can have an annular, semicircular, elliptical, oblong, square, rectangular, trapezoidal or polygonal circumference with a surface area between 0.1 and 70 cm.² or between 0.5 and 50 cm² or from 1 to 25 cm² or from 1 to 10 cm². The material used can be copper, aluminum, lead or any other conductive medium that can be deposited or integrated into the pad. Furthermore, the active elements 13 (for example, electrodes) can be made of silver, gold or graphite. The electrodes 13 of the pad 4 can be printed using biocompatible ink, such as silver ink, graphite ink or a combination of inks of different conductive materials.

The active element 13 (for example, the electrode that provides a radio frequency field and/or an electric field) may be a full area electrode having a full active surface. This means that the entire surface of the electrode facing the patient can be made of conductive material deposited or integrated into the pad 4 as mentioned above.

Alternatively, the surface of the electrode 13 facing the patient may be formed by the combination of conductive (e.g., copper) and non-conductive material (e.g., dielectric material, insulating material, pad substrate, air or hydrogel). The electrode 13 may be framed by conductive material and the interior of the frame may have a combination of conductive and non-conductive material. The frame can create the maximum circumference of the electrode from the side facing the patient. The frame may have an annular, semicircular, elliptical, oblong, square, rectangular, trapezoidal or polygonal shape. The interior of the frame 801 may have a structure of a grid 802 as shown in Fig. 8A and 8B with the non-conductive part 803. The frame 801 may have the same thickness as the thickness of the grid lines 802 or the thickness of the frame 801 may be thicker than the grid lines 802 in the range of 1% to 2000% or in the range of 10% to 1000% or from 20 I to 500% or from 50% to 200%. Additionally, the frame 801 may be thinner than the grid lines 802 in the range of 0.01 times to 20 times or in the range of 0.1 times to 10 times or in the range of 0.2 times to 5 times or in the range of C .5 times to 2 times. It may also be possible to design the electrode such that the conductive material of the electrode is tapering from the center 804 of the electrode 13 as shown in Fig. 8C. The thinning step between adjacent grid lines 802 in the direction from the center 804 may be in the range of 0.1 times to 10 times or in the range of 0.2 times to 5 times or in the range of 0.5 times to 2 times with the 801 frame which has the thinnest line of conductive material. Alternatively, the electrode may not be framed, for example, it may have an unbounded grid shape as shown in Fig. 8D. A ratio between the conductive and non-conductive material of the electrode may be between 1% and 99%, or between 5% and 95%, between 10% and 90%, between 20% and 80%. , between 30% and 70%, or between 40% and 60%. Furthermore, the ratio of conductive to non-conductive material of the electrode may be between 1% and 20%, between 10% and 40%, between 33% and 67%, between 50% and 70%. or between 66% and 100%. Such a grated electrode can be very advantageous. It can be much more flexible, can ensure patient contact that is more suitable, and can have much better self-cooling properties than the full area electrode.

In case the active element 13 has the shape of the grated electrode, the energy flow of the grated electrode can be calculated as an energy flow of the grid 802 and/or the frame 801 of the active element 13 and can be in the range of 0.001W/cm²at 1500 W/cm² or 0.01 W/cm² at 1000 W/cm² or 0.5 W/cm² at 500 W/cm².

The active elements 13 may be partially embedded within the flexible substrate layer 42 or the adhesive layer 40 or at the interface of the flexible substrate layer 42 and the adhesive layer 40. The active elements 13 may be supplied and controlled independently by multiple conductors 41a or may be conductively interconnected and supplied/controlled through a single conductor cable 41b. The multiple lead wires 41a may be connected to the active elements 13 through a free space (e.g., hole) in the flexible substrate layer 42. The free space (e.g., hole) may have dimensions such that each lead wire 41a may fit firmly into the substrate layer 42, for example, the conductive wire 41a may be encapsulated by the flexible substrate layer 42. In the case of a single conductive cable connection, the active elements 13 may be partially embedded within the flexible substrate 42 or the adhesive layer 40 or at the interface of the flexible substrate layer 42 and the adhesive layer 40, and the active elements 13 may be connected via a single conductive wire 41b which may be located on the flexible substrate 42 or at the interface of the flexible substrate 42 and the adhesive layer 40. The single conductor cable 41b may leave the pad 4 on its lateral or upper side in a direction away from the patient. In both cases, the lead wire 41a or 41b does not come into contact with the treatment area.

Additionally, the active elements 13 may be partially embedded within the flexible substrate 42 and the adhesive layer 40 may surround the active elements 13 such that a surface of active elements 13 may be at least partially in direct contact with the surface of an area of treatment.

The total thickness of the pad at the narrowest point can be in the range of 0.1 mm to 60 mm or in the range of 0.5 mm to 50 mm or in the range of 0.7 mm to 40 mm or in the range of 1 mm to 30mm

The apparatus configured in a fractional arrangement may have the active element 13 comprising an array formed by active points of defined size. These points are separated by inactive (and therefore untreated) areas that allow for faster healing of the tissue. The surface containing active points may constitute 1 to 99% or 2 to 90%, 3 to 80% or 4 to 75% of the entire surface of the active element. The active points may have blunt ends on the tissue contact side that do not penetrate the tissue, wherein the tissue in surface contact may have a surface area in the range of 500 pm.² at 250,000 pm² or in the range of 1000 pm² at 200,000 pm² or in the range of 200 pm² at 180,000 pm² or in the range of 5000 pm² at 160,000 pm². The blunt end may have a radius of curvature of at least 0.05 mm. A tissue diameter in surface contact of an active spot may be in the range of 25 pm to 1500 pm or in the range of 50 pm to 1000 pm or in the range of 80 pm to 800 pm or in the range of 100 pm to 600 pm.

Furthermore, the device can employ a safety system that includes thermal sensors and a circuit capable of adjusting the therapy parameters based on the measured values. One or more thermal sensors, depending on the number and distribution of the active elements 13, can be integrated into the pad 4 to collect data from different points to ensure homogeneity of heating. Data can be collected directly from the treatment area or from 13 active elements. If uneven heating or overheating is detected, the device can notify the operator and at the same time adjust therapy parameters to prevent burns to the patient. The treatment parameters of one or more active elements can be adjusted. The main therapy parameters are power, duty cycle and time period which regulate switching between multiple active elements 13. Therapy can be automatically interrupted if the temperature rises above the safe threshold.

Additionally, impedance measurement can be incorporated to monitor the appropriate active element 13 upon contact with the skin. If the impedance value is outside the allowed limits, the therapy can be automatically suspended and the operator can be informed about possible contact problems.

The CPU 11 may be incorporated into the pad 4 itself or may form a separate part conductively connected to the pad 4. In addition to the control mechanism, the CPU 11 may also contain main indicators (for example, therapy in progress, actual temperature and contact of the active element with the skin).

Fig. 5 shows some appliance administration approaches for contact therapy.

It is possible to switch between multiple active elements 13 within the single platform 4 such that the multiple active elements 13 deliver energy simultaneously, successively or in an overlapping method or any combination thereof. For example, in case of two active elements: In simultaneous method, both active elements are used simultaneously during the time interval, for example, 1-20 s. In the successive method, the first active element is used during the first time interval, for example, from 1 s to 10 s. The first active element is stopped and the second active element is used immediately at a later time interval, for example, 10 s to 20 s. This successive step can be repeated. In the overlapping method, the first active element is used for a time interval for, for example, 1-10 s, and the second active element is used for a second overlapping time interval for, for example, 1-10 s. , in which during the second time interval the first active element and the second active element overlap, for example, with a total method overlap time of 0.19.9 s. The active elements 13 can supply power sequentially in predefined switching order or randomly, as set by the operator through the human-machine interface 8. Scheme I in Fig. 5 represents the switching between pairs/groups formed by elements non-adjacent active elements 13 located within a pad 4. Each pair/group of active elements 13 is delivering energy for a predefined period of time (dark gray elements in Fig. 5 - in elements 1 and 3 of scheme I), while the remaining pairs/groups of active elements 13 remain inactive in terms of power supply (light gray elements in Fig. 5 - in elements 2 and 4 of scheme I ). After a predefined period of time, energy is delivered by another pair/group of active elements 13 and the initial active elements become inactive. This is indicated by arrows in Fig. 5. Switching between pairs/groups of active elements 13 can continue until a target temperature is reached throughout the treatment area or until all active elements 13 supply a predefined energy. Scheme II in Fig. 5 represents the switching of all active elements 13 within pad 4 between the ON state when the active elements are delivering power and CFF when they are not delivering power. The duration of the ON and OFF states may vary depending on the predefined settings and/or the information provided by the sensors, for example, thermal sensors. Scheme III in Fig. 5 shows the sequential switching of individual active elements 13 within a pad 4. Each active element 13 supplies energy for predefined periods of time until a target temperature is reached throughout the treatment area or all active elements 13 supply a predefined energy. This sequential switching can be executed clockwise or counterclockwise. Scheme IV in Fig. 5 represents a zig-zag switching order during which preferably non-adjacent active elements 13 deliver power sequentially until all active elements 13 within a pad 4 have been turned on. Each active element 13 supplies energy for a predefined period of time until a target temperature is reached throughout the treatment area or all active elements supply a predefined energy.

The CPU may be configured to control the stimulation device and provide treatment using at least one treatment protocol that improves visual appearance. The treatment protocol is a set of parameters of primary electromagnetic energy and secondary energy that guarantees the desired treatment effect. Each pad can be controlled to provide the same or, alternatively, a different protocol. Paired areas or areas where a symmetrical effect is desired can be treated with the same treatment protocol. Each protocol can include one or more sections or steps.

As a non-limiting example: in case of applying the radio frequency energy by the active elements one by one as shown in Scheme III and IV in Fig. 5, the time in which an active element delivers the radio frequency energy to the tissue of the patient may be in the range of 1 ms to 10 s or in the range of 10 ms to 5 s or in the range of 50 ms to 2 s or in the range of 100 ms to 1500 ms. Two consecutive elements can be turned on and off in successive or overlapping methods. Furthermore, the delivery of the radiofrequency energy by two consecutive active elements can be separated by the timing of no or low radiofrequency stimulation, such that neither of the two consecutive active elements provides radiofrequency heating of the treatment tissue. The stimulation time with no or low radiofrequency may be in the range of 1 ps to 1000 ms, or in the range of 500 με to 500 ms or in the range of 1 ms to 300 ms or in the range of 10 ms to

250 ms.

In the case of treatment when more than one pad is used, sequential switching of the active elements providing radiofrequency treatment may be provided within each pad independently of the other pads or the active elements may deliver energy sequentially across all pads. .

As an example for three dependent pads, each with two active elements: first step: the radio frequency can be provided by active element one in the first pad, in which other active elements are turned off, second step: active element two of the first pad turns on and the rest of the active elements are off, third step: active element one of the second pad is on and the rest of the active elements are off, fourth step: the active element two of the second pad is on and the rest of the active elements are off, fifth step: the active element one of the third pad is on and the rest of the active elements are off, Sixth step: the active element two of the third pad is on and the rest of the active elements are off.

Another non-limiting example may be: first step: the radio frequency can be provided by the active element one in the first pad, in which other active elements are turned off, second step: the active element one of the second pad is turned on and the rest of the active elements are turned off, third step: the active element one of the third pad is on and the rest of the active elements are off, Fourth step: active element two of the first pad is on and the rest of the active elements are off, fifth step: active element two of the second pad is on and the rest of the active elements are off, sixth step: active element two of the third pad is on and the rest of the active elements are off.

In case the pads are treating paired areas (e.g. cheeks, thighs or buttocks), where a symmetrical effect is desired, the pair pads can be powered by the same protocol at the same time.

An example treatment protocol for a pad that delivers radiofrequency energy for patient warming and electrical current that causes muscle contractions is as follows. The protocol may include a first section where the electrodes on a pad may be treated such that the electrodes provide an electrical current modulated pulses in a modulation envelope of increasing amplitude (increasing envelope) followed by constant amplitude (rectangular envelope) followed by decreasing amplitude modulation (decreasing envelope), all of these three envelopes can together create a trapezoidal amplitude modulation (trapezoidal envelope). The trapezoidal wrap can last from 1 to 10 seconds or 1.5 to 7 seconds or 2 to 5 seconds. The increasing, rectangular or decreasing envelope can last from 0.1 to 5 seconds or 0.1 to 4 seconds or 0.1 to 3 seconds. The increasing and decreasing envelope can last the same time, thus creating a symmetrical trapezoidal envelope. Alternatively, the electrical current may be modulated to a sinusoidal envelope or rectangular or triangular envelope. The respective envelopes that cause muscle contractions can be separated by time of zero or low current stimulation, so that no muscle contraction is achieved or by radiofrequency energy that causes heating of the tissue. During this time without muscle contraction, pressure massage can be provided through suction openings, which can cause relaxation of the muscles. The first section may be pre-programmed in such a way that the electrodes at various locations on the pad can be switched in time to provide alternating current pulses where some other electrodes on the pad may not provide alternating current pulses but only AC pulses. RF that causes tissue heating. All of the electrodes on the pad can ensure the supply (be switched by the switching circuit 14 to provide) RF pulses to heat the tissue during the protocol or protocol section, while only a limited number of the electrodes can provide (be switched by switching circuit 14 to provide) alternating currents for muscle contraction during the protocol or protocol section. The device can be set so that the first section lasts from 1 to 5 minutes.

A second section may follow the first section. The second section may be preprogrammed such that electrodes other than those used in the first section can be switched in time at various locations on the pad to provide alternating current pulses in which some other electrodes (same or different electrodes as those used in the first section) on the pad may not provide AC pulses, but only RF pulses that cause tissue heating.

A third section may follow the second section. The third section can be preprogrammed such that different electrodes than those used in the second section can be switched in time at various locations on the pad to provide alternating current pulses in which some other electrodes (same or different electrodes as those used in the second section) on the pad may not provide AC pulses, but only RF pulses that cause tissue heating.

The protocol can be pre-programmed such that the electrodes that provide the electrical current that causes muscle contractions are switched to provide radiofrequency heating after they produce one, two, three, four or five contractions at most.

The respective sections are assembled by the control unit (CPU) in the treatment protocol to provide at least 60-900 contractions or 90-800 contractions, or 150-700 contractions with a single pad.

The forehead pad may include an electrode design such that anatomical area 1 and anatomical area 2 are stimulated by alternating currents that may cause muscle contractions, while anatomical area 3 is not stimulated by alternating electricity causing muscle contraction. The control unit (CPU) is configured to provide an energizing treatment protocol by alternating electrical currents only those electrodes located in proximity or above anatomical area 1 and 2; and energizing electrodes in proximity to or above the anatomical area 3 by radiofrequency signal only as shown in Fig. 9. The anatomical area 1 and 2 may comprise the frontal muscles and the anatomical area may comprise the center of the Procerus muscle.

The pad used for a cheek treatment (on each side of the face below the eye) may include an electrode design such that the anatomical area comprising the buccinator muscle, masseter muscle, zygomatic muscles, or risorius muscle They are stimulated by electrical currents, which can cause muscle contractions, in which the other anatomical area can only be heated with radiofrequency energy.

Conversely, the pad can be configured such that the arrangement of the electrodes near the eyes (for example, the part of the body comprising the Orbicularis oculi muscles) or the teeth (for example, the part of the body comprising the Orbicularis oris muscles) may not provide energy that causes muscle contractions.

The treatment device can be configured in such a way that in each section or step the impedance sensor provides information about the contact of the pad or active element with the patient to the CPU. The CPU can determine based on preset conditions whether the contact of the pad or active element with the patient is sufficient or not. In case of sufficient contact, the CPU may allow the treatment protocol to continue. In the event of inadequate contact, the titrated pad or active element is turned off and the treatment protocol continues to consecutive pad or active element or the treatment is terminated. The determination of the proper contact of the pad or active element can be displayed on the human-machine interface 8.

Impedance measurement can be performed at the beginning of the section/step, during the section/step, or at the end of the section/step. Impedance measurement and/or appropriate contact evaluation can be determined only on the active electrodes for the given section/step or can be performed on all electrodes of all pads used during the section/step.

Fig. 6 and Fig. 7 are discussed together. Fig. 6 shows a block diagram of a non-contact therapy apparatus 100. Fig. 7 is an illustration of a non-contact therapy apparatus 100. The non-contact therapy apparatus 100 may comprise two main blocks: the main unit 2 and a delivery head 19 interconnected through a fixed or adjustable arm 21.

The main unit 2 may include the electromagnetic generator 6 which may generate one or more forms of electromagnetic radiation in which the electromagnetic radiation may be, for example, in the form of incoherent light or in the form of coherent light (for example, laser light). of predetermined wavelength. The electromagnetic field can be generated mainly by a laser, laser diode module, LED, flash lamp or incandescent bulb. The electromagnetic radiation may be such that it can be absorbed at least partially under the surface of the patient's skin. The wavelength of the applied radiation may be in the range of 100 to 15000 nm or in the range of 200 to 12000 nm or in the range of 300 to 11000 nm or in the range of 400 to 10600 nm or may be in the form of second, third, fourth, fifth, sixth, seventh or eighth harmonic wavelengths of the wavelength ranges mentioned above. The main unit 2 may further comprise a human-machine interface 8 represented by screen, buttons, keyboard, touch panel, touch panel or other control members that allow the operator to check and adjust the therapy and other parameters of the device. The power source 5 located in the main unit may include a transformer, a disposable battery, a rechargeable battery, a power plug or a standard power cord. The output power of the power supply 5 may be in the range of 10 W to 600 W, or in the range of 50 W to 500 W, or in the range of 80 W to 450 W. The indicators 17 can provide information additional information about the current state of the device independently in the human-machine interface 8. The indicators 17 can be carried out through the screen, LEDs, acoustic signals, vibrations or other ways that can be adequately warned.

The delivery head 19 may be interconnected with the main unit through the arm 21 which may form the main optical and electrical path. The arm 21 may comprise transmission means, for example cables or waveguides, for example mirrors or fiber optic cables, for electromagnetic radiation in the form of light or additional electrical signals necessary to power the delivery head 19. The CPU 11 controls the electromagnetic generator 6 which can generate a continuous electromagnetic energy (CM) or a pulse, having a fluence in the range of 0.1 pJ/cm² at 1000 J/cm² or in the range of 0.5 pJ/cm² at 800 J/cm² or in the range of 0.8 pJ/cm² at 700 J/cm² or in the range of 1 pJ/cm² at 600 J/cm²at the output of the electromagnetic generator. The CM mode can operate for a time interval in the range of 0.1 s to 24 hours or in the range of 0.2 s to 12 hours or in the range of 0.5 s to 6 hours or in the range of 1 s to 3 hours. The pulse duration of the electromagnetic radiation operated in the pulse regime may be in the range of 0.1 fs to 2000 ms or in the range of 0.5 fs to 1500 ms or in the range of 1 fs to 1200 ms or in the range of 1 fs to 1000 ms. Alternatively, the pulse duration may be in the range of 0.1 fs to 1000 ns or in the range of 0.5 fs to 800 ns or in the range of 1 fs to 500 ns or in the range of 1 fs to 300 ns. Alternatively, the pulse duration may be in the range of 0.3 to 5000 ps or in the range of 1 to 4000 ps or in the range of 5 to 3500 ps or in the range of 10 to 3000 ps. Or alternatively, the pulse duration may be in the range of 0.05 to 2000 ms or in the range of 0.1 to 1500 ms or in the range of 0.5 to 1250 ms or in the range of 1 to 1000 ms. The electromagnetic generator 6 in the pulse regime can be operated by the CPU 11 in a single shot mode or in a repetition mode or in a burst mode. The frequency of repeat mode or burst mode may be in the range of 0.05 to 10,000 Hz or in the range of 0.1 to 5000 Hz or in the range of 0.3 to 2000 Hz or in the range of 0.5 to 1000 Hz. Alternatively, the frequency of the repeat mode or burst mode may be in the range of 0.1 kHz to 200 MHz or in the range of 0.5 kHz to 150 MHz or in the range of 0.8 kHz to 100 MHz or in the range from 1 kHz to 80 MHz. The single shot mode can be configured to generate a single electromagnetic energy of specific parameters (e.g. intensity, duration, etc.) for irradiation of a single treatment area. The repetition mode can be configured to generate an electromagnetic energy, which may have one or more specific parameters (e.g. intensity, duration, etc.), with a repetition rate of the above-mentioned irradiation frequency of a single treatment area . The burst mode can be configured to generate multiple consecutive electromagnetic energies, which may have variable parameters (e.g. intensity, duration, delay, etc.), during a sequence, in which the sequences are repeated with the frequency mentioned above and in which the sequence may include the same or different sets of consecutive electromagnetic energies.

Alternatively, the device may contain more than one electromagnetic generator 6 for the generation of the same electromagnetic energy or a different electromagnetic energy, for example, one electromagnetic generator is for the generation of an ablative electromagnetic energy and the other is for the generation of a non-ablative electromagnetic energy. In this case, it is possible for an operator to select which electromagnetic generators can be used for a given treatment or the doctor can select a required treatment through the human machine interface 8 and the CPU 11 will select which electromagnetic generators will be used. It is possible to operate one or more electromagnetic generators of device 100 simultaneously, successively, or in an overlapping method. For example, in the case of two electromagnetic generators: In the simultaneous method, both electromagnetic generators are used simultaneously for a time interval, for example, 1-20 ps. In the subsequent method, the first electromagnetic generator is used during the first time interval, for example, 1 to 10 ps. The first electromagnetic generator is stopped and the second electromagnetic generator is used immediately at a later time interval, for example, 10 to 20 ps. This sequence of two or more successive steps can be repeated. In the superposition method, the first electromagnetic generator is used for a time interval, for example, 1-10 ps, and the second electromagnetic generator is used in a second overlapping time interval for, for example, 2-11 ps, wherein during the second time interval the first electromagnetic generator and the second electromagnetic generator are superimposed, for example, with a total superposition method time of 2-10 ps. In the case of more than two electromagnetic generators, the activation and deactivation of the electromagnetic generators in a successive or superimposed method can be actuated by the CPU 11 in the appropriate order for a given treatment, for example, by activating the preheating electromagnetic generator first. , then the ablative electromagnetic generator and then the non-ablative electromagnetic generator.

The active elements 13 in the delivery head 19 may be in the form of optical elements, which may be represented by one or more optical windows, lenses, mirrors, fibers or diffraction elements. The optical element representing the active element 13 may be connected to or contain the electromagnetic generator 6 within the delivery head 19. The optical element may produce a beam of electromagnetic energy, which may provide an energy spot having an energy spot size defined as a tissue surface irradiated by a light beam. A light generator may provide one or more points of energy, for example, by splitting a beam into a plurality of beams. The size of the energy spot can be in the range of 0.001 cm² at 1000 cm², or in the range of 0.005 cm² at 700 cm², or in the range of 0.01 cm² at 300 cm², or in the range of 0.03 cm 2 to 80 cm². Energy points of different or the same wavelength can overlap or separate. Two or more light beams can be applied to the same point at the same time or with a time interval ranging from 0.1 ps to 30 seconds. The energy points may be separated by at least 1% of their diameter, and in addition, the energy points may follow each other closely or may be separated by a gap ranging from 0.01 mm to 20 mm or from 0.05 mm to 15 mm. or from 0.1 mm to 10 mm.

The CPU 11 may further be responsible for switching between the active elements 13 or for moving the active elements 13 within the delivery head 19 so that the electromagnetic radiation can be delivered homogeneously throughout the treatment area marked with the aiming beam 18. The Switching speed between active elements 13 may depend on the amount of energy supplied, the length of the pulse, etc. and the speed of the CPU 11 or other mechanism responsible for switching or moving the active elements 13 (e.g., scanner). Additionally, a device may be configured to switch between multiple active elements 13 such that they deliver power simultaneously, successively, or in an overlapping method. For example, in the case of two active elements: In the simultaneous method, both active elements are used simultaneously during the time interval, for example, 1-20 ps. In the successive method, the first active element is used during the first time interval, for example, 1 to 10 ps.

The first active element is stopped and the second active element is used immediately at a later time interval, for example, 10 to 20 ps. This successive step can be repeated. In the overlapping method, the first active element is used for a time interval for, for example, 1-10 ps, and the second active element is used for a second overlapping time interval for, for example, 2-11 ps. , wherein during the second time interval the first active element and the second active element overlap, for example, with a total method time overlapping for 2-10 ps.

The aiming beam 18 has no clinical effect on the treated tissue and can serve as a tool to mark the area to be treated so that the operator knows what exact area will be irradiated and the CPU 11 can set and adjust the treatment parameters accordingly. . A aiming beam may be generated by a separate electromagnetic generator or by the primary electromagnetic generator 6. The aiming beam 18 can deliver power at a wavelength in the range of 300 - 800 nm and can deliver power at a maximum power of 10 mW.

Additionally, the pad may contain a CPU-driven oistance sensor 11 22 to measure a distance from the active element 13 to the treated point within the treated area marked by the aiming beam 18. The measured value may be used by the

CPU 11 as a parameter to adjust one or more treatment parameters that may depend on the distance between an electromagnetic generator and a treatment point, for example, creep. Information from the distance sensor 22 can be provided to the CPU 11 before each switch/movement of an active element 13 so that the energy supplied remains the same in the treated area regardless of its shape or irregularity.

The patient's skin may be pre-cooled to a selected temperature for a selected duration in at least one treatment portion, the selected temperature and duration for pre-cooling are preferably sufficient to cool the skin to at least a temperature selected by below normal body temperature. The skin may be cooled at least to the selected temperature to a depth less than at least one depth for the treatment portions, such that at least one treatment portion is substantially surrounded by cooled skin. Cooling may continue during the radiation application, where the duration of the radiation application may be greater than the thermal relaxation time of the treatment portions. Cooling can be provided by any known mechanism, including water cooling, spray coolant, the presence of an active solid cooling element (e.g., thermoelectric cooler), or airflow cooling. A cooling element can act as an optical element. Alternatively, a spacer can serve as a cooling element. Cooling may be provided during, before or after treatment with electromagnetic energy. Cooling before treatment can also provide an environment for sudden thermal shock, while cooling after treatment can provide faster regeneration after thermal shock.

The coolant temperature can be in the range of -200°C to 36°C. The temperature of the cooling element during the treatment can be in the range of -80 °C to 36 °C or -70 °C to °C or -60 °C to 34 °C. Additionally, when the pad is not in contact with the patient's skin, cryogenic spray cooling, gas flow, or other non-contact cooling techniques can be used. A cooling gel 15 can also be used on the surface of the skin, either in addition to or instead of one of the cooling techniques indicated above.

Additionally, device 100 may include one or more sensors.

The sensor may provide information about at least one physical quantity 20 and its measurement may give rise to feedback that may be displayed by the human-machine interface 8 or the indicators 17. One or more sensors can be used to detect a variety of physical quantities, including, but not limited to, the energy of supplied electromagnetic radiation or backscattered electromagnetic radiation from the skin, skin impedance, skin resistance, temperature of the treated skin, the temperature of the untreated skin, the temperature of at least one layer of the skin, water content of the device, the phase angle of the energy delivered or reflected, the position of the active elements 13, the position of the supply element 19, the temperature of the cooling medium or the temperature of the electromagnetic generator 6. The sensor may be a temperature, acoustic, vibration, electrical, magnetic, flow sensor, positional, optical, image, pressure, force, energy flow, impedance, current, Hall or proximity. The sensor may be a capacitive displacement sensor, acoustic proximity sensor, gyroscope, accelerometer, magnetometer, infrared camera or thermal imaging camera. The sensor can be invasive or contactless. The sensor may be located in the delivery element 19 or in the main unit 2 or may be part of a distance sensor 22. A sensor may measure more than one physical quantity. For example, a sensor may include a combination of a gyroscope, an accelerometer, or a magnetometer. Additionally, the sensor may measure one or more physical quantities of the treated skin or untreated skin.

The temperature sensor measures and monitors the temperature of the treated skin. The temperature may be analyzed by a CPU 11. The temperature sensor may be a non-contact sensor (e.g., infrared temperature sensor). The CPU 11 may also use algorithms to calculate a temperature below the skin surface based on the skin surface temperature and one or more additional parameters. A temperature feedback system can monitor the temperature and, based on set or preset limits, alert the operator in a human-perceivable manner, for example, at the human-machine interface 8 or through indicators 17. In a limit temperature condition, The device can be configured to adjust the treatment parameters of each active element, for example, power output, activate cooling or stop treatment. The human perceptible form may be a sound, alert message displayed on the human-machine interface 8 or indicators 17 or a color change of any part of the device 100.

A resistance sensor can measure the resistance of the skin, as it can vary for different patients, as well as humidity: humidity and sweat can influence the resistance and therefore the behavior of the skin in the field of energy. Based on the measured skin resistance, the skin impedance can also be calculated.

The information from one or more sensors can be used for the generation of a path in a convenient model, for example, a model of the human body displayed on a human-machine interface screen 8. The path can illustrate a surface or volume of fabric already treated, fabric currently treated, fabric to be treated or untreated fabric. A convenient model may display a temperature map of the treated tissue that provides information about the already treated tissue or the untreated tissue.

The sensor can provide information about the location of bones, inflamed tissue or joints. Such tissue types may not be targeted by electromagnetic radiation due to the possibility of painful treatment. Bones, joints or inflamed tissue can be detected by any type of sensor, such as an image sensor (ultrasound sensor, IR sensor), impedance and the like. A detected presence of these types of tissues can cause general human perceptible signals or interruption of the generation of electromagnetic radiation. Bones can be detected, for example, by a change in tissue impedance or by analysis of reflected electromagnetic radiation.

Additionally, the device 100 may include an emergency stop button 16 so that the patient can stop the therapy immediately at any time during the treatment.

It may be part of the invention that the treatment method includes the following steps: tissue preparation; position the proposed device; select or configure the treatment and energy application parameters. More than one step can be executed simultaneously.

Tissue preparation may include removing makeup or cleansing the patient's skin. For higher target temperatures, anesthetics can be applied topically or in an injection.

Positioning of the device may include selecting the correct shape of the pad according to the area to be treated and securing the pad or neutral electrode to the patient, for example, with an adhesive layer, vacuum suction, band or mask. , and verify adequate contact with the treated tissue in the case of contact therapy. In the case of non-contact therapy, positioning of the device may include adjusting the aiming beam of the proposed device so that the device can measure the distance of the active element(s) from the treatment area and adjust the treatment parameters accordingly. .

Selection or configuration of treatment parameters may include adjustment of treatment time, power, duty cycle, delivery time and mode (CM or pulsed), density/surface size of active spots for fractional layout and mode of operation. Selecting the mode of operation may mean choosing simultaneous, successive or overlapping methods or selecting the switching order of active elements or groups of active elements or selecting the appropriate pre-programmed protocol.

The application of the energy may include providing at least one type of energy in the form of RF energy, ultrasound energy, or electromagnetic energy in the form of polychromatic or monochromatic light, or a combination thereof. The energy can be provided by at least one active element in the skin by the proposed device. Energy can be supplied and regulated automatically by the CPU according to information from temperature sensors and impedance measurements and, in the case of contactless therapy, distance sensors. All automatic settings and possible impacts on therapy can be indicated on the device screen. Both the operator and the patient can stop therapy at any time during treatment. A typical treatment may last approximately 1 to 60 minutes or 2 to 50 minutes or 3 to 40 minutes per pad, depending on the area treated and the size and number of active elements located within the pad.

In an example, the application of energy to the tissue may include the delivery of radiofrequency energy or ultrasound energy or their combination, from active elements embedded in the tissue.

After reaching the required temperature and therapy time, the therapy is terminated, the device accessories can be removed, and cleansing of the patient's skin can be provided.