EA044406B1 - DEVICE AND METHOD FOR FULLY AUTOMATIC TREATMENT OF A PATIENT - Google Patents

Description

Cross reference to related applications

The invention claims benefit from U.S. Provisional Patent Application No. 63/019619, filed May 4, 2020, which is incorporated herein by reference in its entirety.

Field of technology to which the invention relates

The present invention relates to methods and equipment for treating a patient with active elements that deliver electromagnetic energy and/or secondary energy so that the treatment area is uniformly treated without the need to manipulate the active elements during therapy.

BACKGROUND OF THE INVENTION

Delivery of various forms of electromagnetic energy into the patient's body for medical and cosmetic purposes has been widely used in the past. These common procedures include, but are not limited to, skin rejuvenation, wrinkle removal, skin tightening and lifting, cellulite and fat reduction, treatment of pigmented areas of the skin, tattoo removal, soft tissue coagulation and ablation, vascular damage reduction, face lifting, muscle contraction and increased muscle strength, etc.

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

In addition to the many undeniable benefits of thermotherapy, these procedures also come with certain limitations and associated risks. Among other disadvantages is the limited ability to provide reproducible results, as they are highly dependent on the treatment techniques used and the ability of the operator. Moreover, if therapy is not performed properly, there is an increased risk of burns and negative consequences.

It is very difficult to ensure uniform energy distribution if the energy delivery is manually controlled by the operator, which is the most common procedure. Certain areas are easy to over- or under-treat. In this regard, devices have emerged containing scanning or other mechanisms capable of delivering to the skin in a fully automatic mode. These devices typically deliver energy without direct contact with the area being treated and only to a limited, precisely defined area without visible unevenness. Maintaining the same distance between the tissue being treated and the energy generator or maintaining adequate contact with the tissue may be difficult when performing treatment on uneven or rough areas. Consequently, the use of widely available devices on such specific areas, which furthermore differ from patient to patient (eg, on the face) may be practically impossible.

A fully automatic facial procedure, in addition to the complications caused by attachment to rough areas and the need to adapt to the shapes of different patients, is characterized by an increased need to protect against burns and other side effects. Although the face heals more easily than other areas of the body, it is also more exposed, resulting in increased treatment interval requirements. Another important aspect of the procedure performed on the face is that the face contains the most important human sensory organs, the function of which should not be impaired during treatment. First of all, it is necessary to ensure eye safety throughout the treatment.

Today's aesthetic therapy market offers traditional manually operated radiofrequency or light-emitting devices that heat facial tissue to a target temperature ranging from 40 to 100°C, or fully automatic LED face masks that rely on light (phototherapy) rather than influence of temperature. These masks are primarily intended for home use and do not pose a risk to patients from burns, overheating, or overtreatment. Variation in facial shapes of individual patients does not present any problems with 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 uniform treatment. Moreover, due to the low temperatures, such devices do not necessarily have to maintain a predetermined distance between the individual diodes and the patient's skin, and the shape of the masks only very roughly matches the shape of the human face. However, their use is very limited by low energy and negligible thermal effect, and therefore they are considered a preventive treatment for daily use rather than an outpatient skin rejuvenation treatment with immediate effect.

Currently, the aesthetic medicine market is experiencing a need for a combination of thermal treatment, carried out by electromagnetic energy delivered to the epidermis, dermis, hypodermis or fatty tissue, with secondary energy providing muscle contractions or muscle stimulation in the area to improve the patient's appearance. However, none of the actual devices are designed to treat uneven, rough areas such as the face. Additionally, commercially available devices are typically hand-held devices that must be operated by a healthcare professional throughout the treatment.

Therefore, there is a need to improve medical devices that provide more

- 1 044406 one type of healing energy (for example, electromagnetic energy and electric current), so that both types of energy can be delivered through different active elements or the same active element (for example, an electrode). In addition, the applicator or contact plate of the device must be attached to the patient, allowing for fully automatic treatment of the patient. In some embodiments, the applicator or contact plate is made of a flexible material that provides sufficient contact with the uneven treatment area on a part of the patient's body.

The essence of the invention

To enable well-defined, fully automatic treatment of uneven, rough areas of a patient (eg, the facial area) while ensuring safety, methods and devices have been proposed for minimally invasive or non-invasive delivery of electromagnetic energy through one or more active elements.

The patient may include skin and a body part, wherein the body part may be referred to as a body region.

The desired effect of improving a patient's appearance may include heating tissue (eg, skin) between 40 and 50°C, coagulating tissue at temperatures between 40 and 80°C, or ablation of tissue at temperatures between 60 and 100°C. Different patients and skin conditions may require different treatment approaches - higher temperatures provide better results in fewer sessions but require longer healing periods, while lower temperatures allow treatment without downtime but with limited results over longer periods of time. number of sessions. In some embodiments, another effect of heating is to reduce the number of fat cells.

Another desired effect may be muscle contraction, which results in muscle stimulation (eg, increased strength or tone) to improve the patient's appearance.

A design has been proposed for contact or non-contact therapy.

For contact therapy, the proposed device contains at least one electromagnetic energy generator within a main assembly that generates electromagnetic energy that is delivered to the treatment area by at least one active element attached to the skin. The at least one active element may be integrated into a contact plate made of a flexible material that conforms to the shape of the rough surface. The underside of the contact plate may contain an adhesive layer to allow adhesion of the active elements to the treatment area and maintain the necessary contact with the tissue. In addition, the device may utilize a safety system capable of adjusting one or more therapy parameters based on measured values obtained from at least one sensor, such as temperature sensors or impedance sensors capable of measuring the quality of contact with the tissue being treated.

For non-contact therapy, the proposed device contains at least one electromagnetic energy generator within the main assembly, which generates electromagnetic energy that is delivered to the treatment area by at least one active element located at a certain distance from the tissue to be treated. The distance between the at least one active element and the treatment area may be monitored before treatment, throughout treatment, or after treatment. In addition, the device may utilize a safety system capable of adjusting one or more therapy parameters based on measured values obtained from at least one sensor, such as one or more distance sensors. The energy can be delivered through one or more static active elements or by moving one or more active elements throughout the treatment area, for example, through an integrated automatic moving system, such as an integrated scanner. Treatment areas can be set using a laser sight - the operator can mark the area to be treated before treatment.

The active element can deliver energy over its entire surface or through a so-called fractional design, where the active part contains a matrix formed by dots of a certain size. These points can be separated by inactive (and therefore untreated) areas, which allow the tissue to heal more quickly. The surface of the dots can be from 1 to 99% of the area of the active element.

Electromagnetic energy can mainly be generated by a laser, laser diode module, LED, flash lamp or incandescent light bulb, or radio frequency generator to provide heating to the patient. Additionally, sound energy or electrical or electromagnetic energy that does not heat the patient may be delivered simultaneously, alternately, or overlapping with the primary electromagnetic energy.

An active element can deliver more than one type of energy simultaneously (at the same time), sequentially, or overlapping. For example, the active element can deliver radio frequency energy and subsequently electrical energy (electrical current). In another example, the active element may deliver radio frequency energy and electrical energy at the same time.

- 2 044406

In addition, the device may be configured to deliver an electromagnetic field through at least one active element and simultaneously (at the same time) deliver, for example, electrical energy through another element.

Thus, the proposed methods and devices can provide proper skin rejuvenation, wrinkle elimination, skin tightening and lifting, cellulite and fat reduction, treatment of pigmented areas of the skin, tattoo removal, coagulation and ablation of soft tissues, reduction of vascular damage, etc. uneven rough areas without damaging important parts of the patient's body, such as nerves or internal organs. The proposed method and devices can provide reduction of adipose tissue, for example, through lipolysis or apoptosis of fat cells.

In addition, the proposed methods and devices can provide tissue rejuvenation, such as increased muscle strength or increased muscle tone through muscle contraction caused by electrical or electromagnetic energy.

Brief description of graphic materials

In fig. Figure 1 shows a block diagram of equipment for contact therapy.

In fig. Figure 2 shows an image of equipment for contact therapy.

In fig. 3A shows possible shapes and layout of the contact plate.

In fig. 3B shows possible shapes and layout of the contact plate.

In fig. 4 is a side view of a contact plate for contact therapy.

In fig. Figure 5 shows one option for delivering energy by switching several active elements.

In fig. Figure 6 shows a block diagram of equipment for non-contact therapy.

In fig. Figure 7 shows an image of equipment for non-contact therapy.

In fig. 8A shows an image of a grid electrode with a frame.

In fig. 8B is an image of another grid electrode with a frame.

In fig. 8C is an image of a grid electrode with a frame with thinning conductive lines.

In fig. 8D is an image of the grid electrode without a frame.

In fig. 9 shows an image of an applicator for placement on the forehead.

Detailed description

The present methods and devices can provide stimulation and/or treatment of tissue, including, but not limited to, skin, epidermis, dermis, hypodermis, or muscle. The proposed equipment is designed for minimally invasive or non-invasive treatment of one or more tissue areas to provide well-defined, fully automatic treatment of uneven, rough areas (for example, the facial area) by delivering electromagnetic energy through one or more 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 areas of the body, for example, the head, neck, chest fat, waist fat, torso, back, abdomen, buttocks, thighs, calves, legs, arms, forearms, hands, fingers or body cavities (eg vagina, anus, mouth, inner ear, etc.).

The proposed methods and devices may provide multiple protocols to enhance the appearance, which may be programmed into a control unit (eg, a CPU, which may include a flex circuit or printed circuit board and may include a microprocessor or memory device for controlling the device).

The desired effect may include heating (heat therapy) the tissue (eg skin) in the range of 37.5 to 65, or in the range of 38 to 60, or in the range of 39 to 55, or in the range of 40 to 50, coagulation of the tissue at temperatures ranging from 37.5 to 95, or in the range from 38 to 90, or in the range from 39 to 85, or in the range from 40 to 80, or tissue ablation at temperatures in the range from 50 to 130, or in the range from 55 to 120, or in the range from 60 to 110, or in the range from 60 to 100°C. The device can be operated by contact or non-contact methods. For contact therapy, the target skin temperature can typically be in the range of 37.5 to 95, or in the range of 38 to 90, or in the range of 39 to 85, or in the range of 40°C to 80°C, while For non-contact therapy, the target skin temperature may be in the range of 37.5 to 130, or in the range of 38 to 120, or in the range of 39 to 110, or in the range of 40 to 100°C. Temperatures in the range of 37.5 to 130, or in the range of 38 to 120, or in the range of 39 to 110, or in the range of 40 to 100 ° C can lead to stimulation of fibroblasts and the formation of connective tissue - e.g. 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 in the range of 37.5 to 130, or in the range of 38 to 120, or in the range of 39 to 110, or in the range of 40 to 100 ° C can additionally lead to changes in adipose tissue. During the process of apoptosis induced by high temperatures, fat cells are broken down into apoptotic bodies and are further eliminated through the process of phagocytosis. In a process called necrosis, fat cells rupture due to high temperatures and their contents are released into the extracellular matrix. Both processes can reduce fat layers, allowing for changes in facial shape. Removing fat from the face can be beneficial, for example in areas such as the submentum or cheeks.

Another desired effect may include tissue rejuvenation, such as increased muscle strength through muscle contraction caused by electrical or electromagnetic energy that does not heat the patient, or muscle relaxation caused by massage pressure. The combined effect of contracting muscles using electrical energy and heating tissue (such as skin) using an electromagnetic field as described can lead to significant improvements in appearance.

Fig. 1 and fig. 2 are considered together. In fig. 1 shows a block diagram of equipment 1 for contact therapy. In fig. 2 shows an image of equipment 1 for contact therapy. The contact therapy equipment 1 may comprise two main units: a main assembly 2 and a contact plate 4. Additionally, the equipment 1 may include an interconnecting block 3 or a neutral electrode 7. However, components of the interconnecting block 3 may be embedded in the main assembly 2.

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

The RF energy output power may be less than or equal to 450, 300, 250, or 220 W. Additionally, the radio frequency energy at the output of the primary electromagnetic generator 6 (for example, a radio frequency generator) may be in the range of 0.1 to 400, or in the range of 0.5 to 300, or in the range of 1 to 200, or in the range of 10 to 150 W. RF energy can be supplied in the industrial scientific and medical (ISM) bands at 6.78 MHz, 13.56, 27.12, 40.68, 433.92, 915 MHz, 2.45 GHz and 5.8 GHz or around these frequencies.

The main node 2 may further include a human-machine interface 8, represented by a display, buttons, keyboard, touchpad, touchpad or other controls that allow the operator to check and adjust therapy parameters and other device parameters. For example, it is possible to set the power, treatment duration, or other treatment parameters for each generator (primary electromagnetic generator 6, secondary generator 9, and ultrasonic emitter 10) independently of each other. The human-machine interface 8 may be coupled to the CPU 11. The power supply 5 located in the main node 2 may include a transformer, a disposable battery, a rechargeable battery, a power connector, or a standard power cable. The output power of the power supply 5 may be in the range of 10 to 600, or in the range of 50 to 500, or in the range of 80 to 450 W.

The interconnecting unit 3 may serve as a communication channel between the main unit 2 and the contact plate 4. It may be a simple device containing the main indicators 17 and mechanisms for controlling therapy. The indicators 17 may be implemented through a display, LEDs, audible signals, vibrations, or other forms capable of providing a sufficient message to the operator and/or the patient. The indicators 17 may indicate the patient's actual temperature, contact information or measurements of other sensors, as well as the status of the switching process between active elements, the quality of contact with the tissue being treated, the actual treatment parameters, the treatment being performed, etc. The indicators 17 may be configured to alert the operator to suspicious therapy progress, such as out-of-range temperature, improper contact with treated tissue, auto-adjustment of parameters, etc. Interconnecting block 3 can be used as an additional safety measure for heat sensitive patients. It may include an emergency stop button 16 so that the patient can immediately stop the therapy at any time during treatment. Switching circuit 14 may provide switching between active elements or adjustment of energy delivery from primary electromagnetic generator 6, secondary generator 9, or ultrasonic emitter 10. The intensity of switching between active elements 13 may depend on the amount of energy delivered, pulse length, etc. and/or the speed of switching circuit 14 and CPU 11. Switching circuit 14 may comprise a relay switch, a transistor (bipolar, PNP, NPN, FET, JFET, MOSFET), a thyristor, a diode, or an optomechanical switch, or any other suitable switch known in the art. field of technology. The switching circuit in conjunction with the CPU can control switching between primary electromagnetic energy generated by the primary electromagnetic generator 6 and secondary energy generated by the secondary generator 9 on the at least one active element.

Additionally, the interconnecting unit 3 may comprise a primary electromagnetic generator 6, a secondary generator 9, or an ultrasonic emitter 10, or only one of them, or any combination thereof.

The CPU 11 controls the primary electromagnetic generator 6 so that the primary electromagnetic energy can be delivered in a continuous mode (CM) or pulsed mode to at least one active element, having an integrated flux density in the range of 10 mJ/cm ² to 50 kJ/cm ² , or in the range from 100 mJ/ ^cm2 to 10 kJ/ ^cm2 , or in the range from 0.5 J/ ^cm2 to 1 kJ/ ^cm2 . Electromagnetic energy can mainly be generated by a laser, laser diode module, LED, flash lamp or incandescent light bulb, or radio frequency generator to provide heating to the patient. The SM mode can be operated over a time interval in the range from 0.05 s to 60 min, or in the range from 0.1 s to 45 min, or in the range from 0.2 s to 30 min. The duration of the energy delivery pulse when operated in pulse mode can 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 CPU 11 can operate the primary electromagnetic generator 6 in a pulse mode, in a single pulse mode or in a repeat mode. The repeat mode frequency can be in the range of 0.05 to 10000, or in the range of 0.1 to 5000, or in the range of 0.3 to 2000, or in the range of 0.5 to 1000 Hz. Alternatively, the repeat mode frequency 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 of 1 kHz to 80 MHz . Single pulse mode may mean generating just one electromagnetic pulse with specific parameters (eg, intensity, duration, etc.) to deliver to one treatment area. A repetition mode may mean generating one or more electromagnetic pulses, which may have specific parameters (eg, intensity, duration, etc.), at the aforementioned pulse repetition rate for delivery to one treatment area. CPU 11 may provide treatment control such as stabilization of treatment parameters, including treatment duration, power, duty cycle, time period governing switching between multiple active elements, temperature of device 1, and temperature of primary electromagnetic generator 6 and secondary generator 9 or ultrasonic emitter 10. The CPU 11 may drive the switching circuit 14 and provide information from it. The CPU 11 may also receive and provide information from sensors located on or in the contact plate 4 or anywhere in the device 1. The CPU 11 may include a flexible circuit or printed circuit board and may include a microprocessor or memory device for controlling the device.

The CPU 11 may control the secondary generator 9 such that the secondary energy (eg, electric current or magnetic field) can be delivered in a continuous mode (CM) or pulsed mode to the at least one active element, having an integrated flux density in the range of 10 mJ /cm ² to 50 kJ/cm ² , or in the range from 100 mJ/cm ² to 10 kJ/cm ² , or in the range from 0.5 J/cm ² to 1 kJ/cm ² on the surface of at least one active element. Delivery of secondary energy to the patient's treatment area may cause the patient's muscles to contract. The SM mode can be operated over a time interval in the range from 0.05 s to 60 min, or in the range from 0.1 s to 45 min, or in the range from 0.2 s to 30 min. The duration of the secondary energy delivery pulse when operating in pulse mode can be in the range from 0.1 μs to 10 s, or in the range from 0.2 μs to 1 s, or in the range from 0.5 μs to 500 ms. The secondary generator 9 in pulse mode can be operated by CPU 11 in single pulse mode or in repeat mode. The repeat mode frequency can range from 0.1 to 12000, or from 0.1 to 8000, or from 0.1 to 5000, or from 0.5 to 1000 Hz.

The proposed device may be a multi-channel device allowing the CPU 11 to control treatment of more than one treatment area simultaneously.

Alternatively, the interconnect unit 3 may not be part of the device 1, and the CPU 11, switch circuit 14, indicators 17, and emergency stop button 16 may be part of the main assembly 2 or contact plate 4. In addition, some of the CPU 11, switch circuit 14, The indicators 17 and the emergency stop button 16 may be part of the main assembly 2, and some of them are part of the contact plate 4, for example, the CPU 11, the switching circuit 14 and the emergency stop button 16 may be part of the main assembly 2, and the indicators 17 may be part of contact plate 4.

The contact plate 4 represents the part of the device that can be in contact with the patient's skin during therapy. The contact plates 4 can be made of a flexible backing material, for example a polymer-based material, polyimide (PI) films, Teflon, epoxy resin, polyethylene terephthalate (PET), polyamide or polyethylene foam with an additional adhesive layer on the underside, for example a hypoallergenic adhesive gel or adhesive tape, which can be bacteriostatic, non-irritant or water soluble. The support may also be a silicone based support. The backing may also be made of a fabric, for example a non-woven fabric. The adhesive layer may have an impedance for a current with a frequency of 500 kHz in the range of 1 to 150 ohms, or in a range of 5 to 130 ohms, or in a range of 10 to 100 ohms, and the impedance for a current of 100 Hz or less exceeds the impedance for current at 500 kHz is three times or more. The adhesive hydrogel can be made of a polymer matrix or mixture containing water, a polyhydric alcohol, polyvinylpyrrolidone, a polyisocyanate component, a polyol component, or contains a methylene diphenyl structure in the main chain. Additionally, the conductive adhesive may be supplemented with metal fillers such as silver, gold, copper, aluminum, platinum or titanium, or graphite, which constitute from 1 to 90, or from 2 to 80, or from 5 to 70% of the adhesive. The adhesive layer may be coated with ST-gel® or Tensive® conductive adhesive gel, which is applied to the body to reduce its impedance, thereby facilitating the delivery of the electrical shock.

The adhesive layer under the contact plate 4 may mean that the adhesive layer is located between the patient-facing surface of the contact plate and the patient's body. The adhesive layer may have an impedance that is 1.1, 2, 4, or up to 10 times the impedance of the patient's skin under the contact plate 4. The definition of skin impedance may be that it is a fraction of the total impedance measured between two equipotential surfaces in contact with the epidermis, which is inversely proportional to the electrode area when the flow path of the internal current is kept constant. Data applicable to this definition will conveniently be reported as admittance per unit area to facilitate application to other geometries. The impedance of the adhesive layer can be determined using the same experimental setup used to measure the impedance of the skin. The impedance of the adhesive layer may be higher than the impedance of the skin by a number of times which is in the range of 1.1 to 20, or 1.2 to 15, 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 radio frequency and for the delivery of electrical current. The hydrogel impedance may be in the range of 100 to 2000 ohms, or in the range of 150 to 1800, or 200 to 1500, or 300 to 1200 ohms in the case of electrical current delivery (eg, during electrotherapy).

The contact plate 4 may also include a sticker on the top side of the contact plate. The top side is the side opposite the bottom side (the side where the adhesive layer can be applied), or in other words, the top side is the side of the contact plate facing away from the patient during treatment. The sticker may have a bottom side and a top side, where the bottom side of the sticker may contain an adhesive layer and the top side of the sticker may contain a non-stick layer (for example, polyimide (PI) films, Teflon, epoxy resin, polyethylene terephthalate (PET), polyamide or polyethylene foam) .

The sticker may have the same shape as the contact plate 4, or may additionally overlap the contact plate. The sticker may be adhered to the contact plate such that the adhesive layer of the bottom side of the sticker faces the top side of the contact plate 4. The top side of the sticker facing away from the contact plate 4 may be made of a non-adhesive layer. The size of the additional overlap sticker can exceed the size of the contact plate in the range of 0.1 to 10, or in the range of 0.1 to 7, or in the range of 0.2 to 5, or in the range of 0.2 to 3 cm. This overlap may also comprise an adhesive layer and may be used to provide additional and more suitable contact of the contact plate with the patient.

Alternatively, the contact plate 4 may include at least one suction opening, for example, small cavities or slits located adjacent to the active elements, or the active element may be enclosed within the cavity. The suction port may be connected through a connecting pipe to a pump, which may be part of the main assembly 2. When the suction port is brought into contact with the skin, the air sucked from the suction port flows to the connecting pipe and the pump, and the skin can be slightly sucked into the suction port. hole. In this way, by applying a vacuum, the contact plate 4 can be ensured to adhere. In addition, the contact plate 4 may include an adhesive layer and suction holes for combined stronger adhesion.

In addition to vacuum (negative pressure), a pump can also provide positive pressure by pumping fluid to a suction port. Positive pressure is pressure that is above atmospheric pressure, and negative pressure or vacuum is pressure that is below atmospheric pressure. Atmospheric pressure is the air pressure in the room during therapy.

Pressure (positive or negative) can be applied to the treatment area in the form of pulses to provide a massage treatment. Massage treatment can be provided by one or

- 6 044406 more suction holes changing the amount of pressure applied to the patient's soft tissue, that is, the suction hole applies different pressure to the patient's tissue. In addition, the suction holes can create a pressure differential in the soft tissue without touching the skin. Such pressure differences may target the soft tissue layer, the subsurface of the skin, and/or other soft tissue structures.

Massage accelerates and improves healing therapy using electromagnetic energy, electrical energy or electromagnetic energy, which does not heat the patient, improves blood and/or lymph circulation, eliminates angioedema, erythema effect, accelerates fat removal, accelerates metabolism and accelerates elastogenesis and/or neocollagenesis .

Each suction port may provide pressure through a suction mechanism, air flow or gas flow, liquid flow, pressure provided by an object located in the suction port (for example, a massage object, pressure cells, etc.), and/ or in other ways.

The pressure value applied to the patient tissue means that the suction port providing the massage effect applies positive, negative and/or sequential positive and negative pressure to the treated and/or adjacent tissue structures of the patient and/or creates a pressure difference under the surface of the tissue patient.

Massage used to improve the flow of bodily fluids (eg, lymphatic drainage) and/or tissue relaxation in the superficial soft tissue layers may be applied at a pressure that is lower than the pressure used during massage of the deeper soft tissue layers. Such positive or negative pressure compared to atmospheric pressure may be in the range of 10 to 30,000 Pa, or in the range of 100 to 20,000 Pa, or in the range of 0.5 to 19 kPa, or in the range of 1 to 15 kPa.

Massage used to improve the flow of bodily fluids and/or relax tissue in the deeper layers of soft tissue may be applied at higher pressures. Such positive or negative pressure may range from 12 to 400, or from 15 to 300, or from 20 to 200 kPa. The feeling of discomfort from too much applied pressure can be used to set the pressure threshold according to the individual wishes of the patient.

Negative pressure can stimulate the flow of body fluids and/or relaxation of deeper soft tissue layers (0.5 cm to unlimited depth in soft tissue) and/or soft tissue layers at the patient's surface (0.1 ^mm2 to 0.5 cm ). Negative pressure treatment followed by positive pressure treatment can be used to increase the effectiveness of the massage.

The number of suction holes that change the pressure values on the patient's soft tissue in one contact plate 4 can be from 1 to 100, or from 1 to 80, or from 1 to 40, or from 1 to 10.

The sizes and/or shapes of the suction openings may vary depending on the characteristics of the area being treated. One suction hole can cover an area on the patient's surface from 0.1 mm ² to 1 cm ² , or from 0.1 to 50 mm ² , or from 0.1 to 40 mm ² , or from 0.1 to 20 mm ² . The other suction opening may cover an area on the patient's surface of 1 cm ² to 1 m ² , or 1 to 100 cm ² , or 1 to 50 cm ² , or 1 to 40 cm ² .

Multiple suction ports can operate simultaneously, or switching between them can be in intervals from 1 ms to 10 s, or in intervals from 10 ms to 5 s, or in intervals from 0.5 s to 2 s.

To provide a massage effect, the suction ports may be directed 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 CPU based on 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 ports can be gradually applied preferentially in the positive direction of lymph flow and/or blood flow in the veins. According to specific treatment protocols, pressure may be gradually applied in a direction opposite or different from the normal flow of lymph. The applied pressure during treatment may vary according to the treatment protocol.

Pressure differences may occur between individual suction ports. The described examples of differences are not limited to this method and/or device. The set value of the pressure difference between at least two previous and subsequent suction openings can be: 0%, i.e. the pressure applied by the suction holes is the same (for example, the pressure in all the suction holes of the contact plate is the same); 1%, i.e. the applied pressure between the previous and subsequent suction ports decreases and/or increases with a difference of 1% (for example, the pressure at the first suction port is 5 kPa and the pressure at the subsequent suction port is 4.95 kPa); or 2%,

- 7 044406

those. pressure decreases or increases with a difference of 2%. The pressure difference between the two suction ports can range from 0 to 100%, where 100% means that one suction port is inactive and/or does not apply any pressure to the patient's soft tissue.

The treatment protocol governing the application of the pressure difference between the previous and subsequent suction ports may be in the range of 0.1 to 95, or in the range of 0.1 to 70, or in the range of 1 to 50%.

The suction port may also include an impact massage object receiving energy from a piston, a massage object operating by filling or pumping liquid or air out of the gap volume using an inlet/outlet valve, or a massage object receiving energy from an element generating an electric field, a magnetic field or electromagnetic field. Additionally, massage can be provided by the impact of several massage objects. 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 a flow of air or fluid (through a valve) or by an electric, magnetic or electromagnetic field. The trajectory of the massage objects can be arbitrary, circular, linear, and/or the massage objects can rotate around one or more axes and/or can perform other types of movements within the gap volume.

The massage unit may also contain a membrane on the patient side, which can be accelerated by an electric, magnetic, electromagnetic field or by changing the pressure value in the gap volume between the chamber wall and the membrane. This membrane can serve as a massage object. During treatment, it may be convenient to use a combination of adhesive pads and suction pads. In this case, at least one contact plate used during treatment may include an adhesive layer, and at least one additional contact plate used during treatment may include a suction hole. For example, a contact plate with an adhesive layer may be suitable for treating rougher areas, such as the periorbital region, while a contact plate with suction holes may be suitable for treating smoother areas, such as the cheeks.

The advantage of a device in which the attachment of the contact plates can be provided by an adhesive layer or a suction hole, or a combination thereof, is that there is no need for any additional adhesion system that might be necessary to hold the contact plates on the treatment area during treatment, for example, tape or felt, which may cause discomfort to the patient.

In yet another embodiment, it is possible to fix flexible contact plates 4 on the surface of at least one tape or felt element, which can be made of elastic material and thus adjusted to a particular surface. In this case, flexible contact plates, which may not contain an adhesive layer or a suction port, are placed on the patient's treatment area and their position is then secured with tape or felt to prevent the contact plates from moving away from the treatment areas. Alternatively, the tape 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 surface and can serve to secure the flexible contact plates to the treatment areas. Additionally, a combination of an adhesive or suction pad and an adhesive tape, felt, or mask can be used to ensure that the pads are securely attached to the treatment areas.

Additionally, the locking mechanism may take the form of a textile or clothing item that can be placed on a part of the user's body. When using the device, the surface of the electrode or electrode contact plate 4 lies along the inner surface of the garment, while the opposite surface of the electrode or electrode contact plate 4 is in contact with the user's skin, preferably through a hydrogel contact surface between the skin and the electrode.

The garment may be secured to secure the garment to or around a portion of the wearer's body, such as by means of a Velcro fastener, button, buckle, cufflink, belt or belt, magnetic guide fastening system, or clip band, and the garment may be manufactured made of flexible materials or fabrics that adapt to the shape of the user's body or limb. The electrode contact plate 4 can be configured in the same way to be fixed to the inner surface of a garment. The garment is preferably made from breathable materials. Non-limiting examples of such materials include soft neoprene, nylon, polyurethane, polyester, polyamide, polypropylene, silicone, cotton or any other soft and flexible material. All of these materials can be used in the form of woven, non-woven, disposable fabric or multi-layer structures.

The garment and the contact plate may be a modular system, which means that the module or element of the device (contact plate, garment) and/or system is designed separately and independently from the other modules or elements, and at the same time they are compatible with each other

- 8 044406 with a friend.

The contact plate 4 may be designed to be coupled or placed in contact with the garment, thereby being carried by the garment in a stationary or fixed state, so that the contact plates are placed at fixed locations of the garment. The garment ensures proper adhesion or placement of the contact plate to the wearer's skin. When the device is used, the surface of one or more active elements not in contact with the garment is in contact with the patient's skin, preferably through a hydrogel layer that serves as a contact surface between the contact plate and the skin. Consequently, the active elements included in the contact plate are in contact with the skin of the patient.

The optimal placement of the contact plate on the part of the patient's body, and therefore the garment that carries the contact plate containing the active elements, can be determined by the technician or medical professional assisting the patient.

In addition, a garment may contain more than one contact plate, or a patient may wear more than one garment containing one or more contact plates during a single treatment session.

The contact plate 4 may contain at least one active element 13 capable of delivering energy from a primary electromagnetic generator 6, or a secondary generator 9, or an ultrasonic emitter 10. The active element may be in the form of an electrode, an optical element, an acoustic window, an ultrasonic emitter or other elements for energy delivery known in the art. The electrode may be a radio frequency (RF) electrode. The RF electrode may be a dielectric electrode coated with an insulating (eg, dielectric) material. The RF electrode can be monopolar, bipolar, unipolar or multipolar. Bipolar placement may consist of electrodes alternating between active and reactive functions, and where the temperature difference under the electrodes is almost constant during treatment. Bipolar electrodes can form circular or elliptical shapes, where the electrodes are located concentrically relative to each other. However, a group of bipolar electrode systems can also be used. A unipolar electrode or one or more multipolar electrodes may also be used. Alternatively, the system can use monopolar electrodes, where the so-called return electrode has a larger area than the so-called active electrode. Consequently, the temperature difference under the active electrode is higher than under the return electrode. The active electrode may be part of the contact plate, and the passive electrode, having a large surface area, may be located at a distance of at least 5, 10 or 20 cm from the contact plate. The neutral electrode can be used as a passive electrode. The neutral electrode may be located on the opposite side of the patient's body from the attached contact plate. Optionally, a unipolar electrode can also be used. During unipolar energy delivery, there is one electrode, no neutral electrode, and a large RF field is emitted as an omnidirectional field around a single electrode. Capacitive and/or resistive electrodes can be used. The radiofrequency energy may provide an energy flux on the surface of the active element 13 or on the surface of the tissue being treated (eg, skin) in the range of 0.001 to 1500, or 0.01 to 1000, or 0.5 to 500, or 0.5 up to 100, or from 1 to 50 W/ ^cm2 . The energy flux on the surface of the active element 13 can be calculated based on the size of the active element 13 and its energy output value. The energy flow at the surface of the treated tissue can be calculated based on 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. In addition, the RF electrode located in the contact plate 4 can act as an acoustic window for ultrasonic energy.

The active element 13 may provide secondary energy from the secondary generator 9 in the form of an electric current or a magnetic field. By applying secondary energy to the treated area of the patient's body, stimulation of muscle fibers can be achieved, thereby increasing muscle tone, increasing muscle strength, restoring muscle sensitivity, relaxing muscles and/or stretching muscles.

The proposed device can provide electrotherapy when the secondary energy delivered by the active element 13 (eg, a radiofrequency electrode, which may simply be referred to as an electrode) is an electrical current. The main effects of electrotherapy are: analgesia, muscle relaxation, iontophoresis, decongestant effect or muscle stimulation leading to contraction of muscle fibers. Each of these effects can be achieved using one or more types of electrotherapy: galvanic current, pulsed direct current, and alternating current.

Galvanic (or continuous) current is a current that has a constant electric current and/or an absolute value of electric current that is greater than 0 at any time. It can mainly be used for iontophoresis, or it can be used

- 9 044406 effect of trophic stimulation (hyperemic effect). In the present invention, this current can be replaced by a galvanic intermittent current. Additionally, the galvanic component may be approximately 95%, but due to the interruption of the initially continuous intensity, the frequency may reach 5-12, or 5-10, or 5-9, or 5-8 kHz.

Pulsed direct current (DC) has variable intensity, but only one polarity. The shape of the main pulse may vary. It includes, for example, diadynamic, rectangular, triangular and exponential pulses of the same polarity. Depending on the frequency and intensity used, this current may have stimulating, trophic, analgesic, muscle relaxation, iontophoresis, at least partial muscle contraction and decongestant effects and/or other effects.

Alternating current (AC or two-phase current) is characterized by a changing shape of the main pulse - rectangular, triangular, harmonic sinusoidal, exponential and/or other shapes and/or combinations of the above mentioned shapes. It can be alternating, symmetrical and/or asymmetrical. The use of alternating currents in contact electrotherapy implies a significantly lower load on the tissue under the electrode. These types of currents engage the capacitive component of the skin's resistance, and because of this, patients tolerate such currents very well.

AC therapies can be divided into five subtypes: transcutaneous electrical nerve stimulation (TENS), classical (quadripolar) interference, bipolar interference, isoplanar interference, and vector dipole field. There are also some electrotherapy-specific energy options and period modularity, energy form, etc.

Thanks to interferential electrotherapy, it is possible to stimulate different nerves and tissue structures with an average frequency in the range of 500 Hz to 12 kHz, or in the range of 500 Hz to 8 kHz, or from 500 Hz to 6 kHz, creating pulse envelopes with frequencies to stimulate 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) and nociceptive fibers (90-150 Hz).

Electrotherapy can provide stimulation with currents ranging in frequency from 0.1 Hz to 12 kHz, or from 0.1 Hz to 8 kHz, or from 0.1 Hz to 6 kHz.

Stimulation of muscle fibers using electrotherapy may be important during and/or as part of RF treatment. Muscle stimulation improves blood and lymph circulation. It may improve the removal of treated cells and/or prevent the creation of hot spots. Moreover, internal massage stimulation of adjacent tissues improves tissue uniformity and dissipation of delivered energy. Stimulation of muscle fibers with electrotherapy can cause muscle contractions, which can lead to an improvement in the patient's appearance by imparting elasticity and strength to the muscles. Another advantageous effect is observed, for example, when removing fat using RF therapy. RF therapy can change the structure of adipose tissue. Stimulation of muscle fibers can provide internal massage, which may be more effective than traditional massage for the obese patient.

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

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

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

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

Electrical stimulation can be provided in monopolar, unipolar, bipolar or multipolar mode.

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

The electrotherapy current density for non-galvanic current may be in the range of 0.1 to 150, or in the range of 0.1 to 100, or in the range of 0.1 to 50, or in the range of 0.1 to 20 mA/ ^cm2 ; For

- 10 044406 galvanic current may preferably be in the range from 0.05 to 3, or in the range from

0.1 to 1, or in the range from 0.01 to 0.5 mA/ ^cm2 . The current density can be calculated based on the surface of the electrode providing electrotherapy to the patient.

During electrotherapy, such as bipolar electrotherapy, two or more electrodes may be used. If the polarity of at least one electrode has a non-zero value in the electrode group in bipolar mode, the electrode group must contain at least one electrode with the opposite polarity value. The absolute values of the polarities of both electrodes may or may not be equal. In bipolar electrical stimulation mode, the stimulating signal passes through tissue between electrodes of opposite polarities.

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

In monopolar electrotherapy mode, a stimulating signal can be induced by generating an action potential by changing the polarity of one electrode, which changes the polarization in the nerve fibers and/or neuromuscular plates.

During electrotherapy, one of the bipolar or monopolar electrotherapy modes may be used, or bipolar or monopolar electrotherapy modes may be combined.

Ultrasonic emitters can provide focused or defocused ultrasonic energy. Ultrasonic energy can be transmitted to tissue through an acoustic window. The output power of ultrasonic energy on the surface of the active element 13 may be less than or equal to 20, or 15, or 10, or 5 W. The ultrasonic energy can provide an energy flux on the surface of the active element 13 or on the surface of the tissue being treated (eg, skin) in the range of 0.001 to 250, or in the range of 0.005 to 50, or in the range of 0.01 to 25 W/cm ² , or in the range from 0.05 to 20 W/ ^cm2 . The treatment depth of ultrasonic energy can range from 0.1 to 100, or 0.2 to 50, or 0.25 to 25, or 0.3 to 15 mm. At a depth of 5 mm, ultrasonic energy can provide energy fluxes ranging from 0.01 to 20 or 0.05 to 15 W/cm ² . The ultrasound beam may have a beam non-uniformity (RBN) coefficient in the range of 0.1 to 20, or 2 to 15, or 4 to 10. In addition, the ultrasound beam may have a beam non-uniformity coefficient (RBN) of less than 15 or less than 10. The ultrasound beam may be divergent, convergent and/or collimated. Ultrasonic energy can be transmitted to tissue through an acoustic window. The RF electrode can serve as an acoustic window. In addition, the ultrasonic emitter 10 may be part of the active element 13, thus the ultrasonic emitter 10 may be part of the contact plate 4.

At least some of the active elements 13 may be capable of delivering energy from the primary electromagnetic generator 6, or the secondary generator 9, or the ultrasonic emitter 10 simultaneously (at the same time), sequentially, or in an overlapping manner, or in any combination thereof. . For example, the active element 13 may be capable of delivering RF 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 may provide secondary energy generated by the secondary generator 9. Thus, the active element 13 can apply, for example, radio frequency energy to the patient's tissue, and then the same active element 13 can apply, for example, an electrical current to the patient's tissue.

The contact plate 4 may further include temperature sensors 15 to control the temperature during therapy, provide feedback to the CPU 11, adjust the treatment parameters of each active element, and provide information to the operator. The temperature sensor 15 may be a contact sensor, a non-contact sensor (eg, an infrared temperature sensor), or an invasive sensor (eg, a thermocouple) to accurately measure the temperature of the deep layers of the skin, such as the epidermis, dermis, or hypodermis. The CPU 11 can also use algorithms to calculate temperatures in the deep layer or the topmost layer. A closed-loop temperature control system may control the temperature and, based on specified or predetermined limits, alert the operator in a human-perceivable form, for example, through a human-machine interface 8 or indicators 17. Under temperature-limited conditions, the device may be configured to adjust one or more treatment parameters, such as output power, switching mode, pulse length, etc., or stopping treatment. The human-perceivable warning may be a sound, a warning message displayed on the human-machine interface 8 or indicators 17, or a change in color of any part of the interconnect block 3 or contact plate 4.

The storage device 12 may contain, for example, information about the type and shape of the contact plate 4, its remaining service life, or the duration of therapy that has already been performed with this contact plate.

- 11 044406

The neutral electrode 7 can ensure proper distribution of radio frequency in the patient's body for monopolar radio frequency systems. A neutral electrode 7 is attached to the patient's skin before each treatment so that energy can be distributed between the active element 13 and the neutral electrode 7. In some bipolar or multipolar RF systems, there is no need to use a neutral electrode; the RF energy is distributed among several active elements 13. Neutral electrode 7 represents an optional equipment block 1, since any type of RF system can be integrated.

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

The resistance sensor can measure skin resistance, as skin resistance may vary between patients, as well as humidity; hydration and sweat can influence the resistance and therefore the behavior of the skin in the energy field. Based on the measured skin resistance, the total skin resistance can also be calculated.

Information from one or more sensors may be used to generate a trajectory on a model, for example, a human body model shown on the display of the human-machine interface 8. The trajectory may represent the surface or volume of tissue that has already been treated, tissue that is currently being treated, tissue that must be treated or untreated tissue. The model may display a temperature map of the tissue being treated, providing information about tissue that has already been treated or tissue that has not been treated.

The sensor can provide information about the location of bones, inflamed tissue or joints. These types of tissue may not be targeted by electromagnetic energy due to the potential for pain during treatment. Bones, joints or inflamed tissue can be detected by any type of sensor such as an image sensor (ultrasonic sensor, IR sensor), impedance sensor, etc. Detection of the presence of these types of tissue may cause the creation of signals normally perceived by humans or the interruption of the generation of electromagnetic energy. Bones can be detected by changes in tissue impedance or by analyzing reflected electromagnetic energy.

The patient's skin over the at least one treatment portion may be pre-cooled to a selected temperature for a selected duration, wherein the selected temperature and duration of pre-cooling may be sufficient to cool the skin to at least a selected temperature that is lower than normal body temperature. The skin may be cooled to at least a selected temperature to a depth greater than at least one depth for the portions being treated such that at least one portion being treated is substantially surrounded by cooled skin. Cooling may continue during energy delivery, and the duration of energy delivery may be longer than the thermal relaxation time of the parts being treated. Cooling may be provided by any known mechanism, including water cooling, atomized coolant, an active solid cooling element (eg, a thermoelectric cooler), or air flow cooling. The cooling element may function as an optical element. Alternatively, the cooling element may be a separator. Cooling can be provided during, before or after treatment using electromagnetic energy. Cooling before treatment may also provide an environment for sudden heat shock, while cooling after treatment may provide accelerated regeneration after heat shock. The refrigerant temperature may be within

- 12 044406 range from -200 to 36°C. The temperature of the cooling element during treatment can range from -80 to 36, or from -70 to 35, or from -60 to 34°C. Additionally, if the contact plate is not in contact with the patient's skin, cryogenic spray cooling, gas flow cooling, or other non-contact cooling techniques may be used. A cooling gel on the surface of the skin may also be used in addition to or instead of one of the cooling techniques mentioned above.

In fig. 3A and FIG. 3B shows various shapes and arrangements of the contact plate 4 used by the contact therapy equipment. The contact plates 4 contain at least one active element 13 and can be available in various shapes and arrangements so that they can cover a number of different treatment areas and suit the needs of the individual patient, for example, annular, semicircular, elliptical, oblong, square, rectangular , trapezoidal, polygonal or indeterminate (without any regular outline or shape). The shapes and arrangements of the contact plate 4 may be selected to cover at least a portion of one or more of the periocular region, forehead (including glabellar lines), jawline, perioral region (including vertical wrinkles extending from the corners of the lips to the chin, perioral wrinkles - so-called smoker's wrinkles, nasolabial folds, lips and chin), cheeks or submentum, etc. The shape of the contact plate 4 and the distribution, size and number of active elements 13 may vary depending on the area being treated, for example, the active elements 13 within the contact plate 4 may be arranged in one line, two lines, three lines, four lines or multiple lines . The active elements 13 may be arranged in the contact plate 4 in various shapes, for example, in the form of a line, where the centers of at least two active elements 13 lie on the same straight line, while any additional center of the active element 13 may lie on that same lines or on other lines inside the contact plate 4.

In addition, the contact plate 4 can be used to treat at least part of the neck, chest fat, waist fat, torso, back, abdomen, buttocks, thighs, legs, legs, arms, forearms, hands, fingers or cavities body (eg vagina, anus, mouth, inner ear, etc.).

The contact plate 4 may be rectangular, oblong, square, trapezoidal, or convex or concave polygonal in shape, and the contact plate 4 may have at least two different inner corners of a convex or concave polygonal structure. Additionally, the contact plate 4 may form at least partially a conical cross-sectional shape (also called conical), such as a circle, ellipse, parabola or hyperbola. The contact plate 4 may have at least partially one, two, three, four, five or more arc-shaped curves with a curvature k in the range of 0.002 to 10 mm ^-1 , or in the range of 0.004 to 5 mm ^-1 , or range from 0.005 to 3 mm ^-1 , or in the range from 0.006 to 2 mm ^-1 . The contact plate 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 treating the chin, cheeks, submental region ( e.g. banana shape 1 4.2), for the treatment of the jaw line, perioral area, vertical wrinkles running from the corners of the lips to the chin and nasolabial folds (e.g. banana shape 2 4.4), for the treatment of the periorbital area (e.g. horseshoe shape 4.3) or other areas of the face and neck. The banana-shaped contact plate 4.2 or 4.4 may 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 to 70, or from 20 to 90% of the entire circumference of the contact plate 4 in a plan view, with the shortest distance between the end points 4.21a and 4.21b of the banana-shaped contact plate 4.2 (dashed line in Fig. 3A) being greater than the shortest distance between the end point 4.21a or 4.21b and banana shape midpoint 4.22 (solid line in contact plate 4.2 in FIG. 3A). The shape of the horseshoe 4.3 in the top view may have a convex-concave shape, which occupies at least 15 to 50, or 20 to 60, or 25 to 70, or 30 to 90% of the entire circumference, with the smallest distance between the end points 4.31a and 4.31b of the horseshoe-shaped contact plate 4.3 (dashed line in Fig. 3B) are equal to or less than the shortest distance between the end point 4.31a or 4.31b and the midpoint 4.32 of the horseshoe shape (solid line in the contact plate 4.3 in Fig. 3B ). In a plan view, if the longest possible central curve, which may be convex or concave, and whose perpendiculars at a given point are equidistant from the edges of the perimeter of the contact plate at each of its points (dashed line in contact plate 4.2 in Fig. 3A) , intersects the circumference of the contact plate 4, then this point is the end point of the contact plate, for example, the end point 4.21a or 4.21b. The midpoint, for example 4.22, is then taken as the midpoint of the central curve, with the total length of the central curve given by the two end points, for example 4.21a and 4.21b, thus the length of the central curve (dashed line in contact plate 4.2 in FIG. 3A) from point 4.21a to point 4.22 is equal to the length from point 4.21b to point 4.22. The total length of the central curve can vary

- 13 044406 zone from 0.1 to 30, or in the range from 0.5 to 25, or in the range from 1 to 20 cm.

In addition, the center curve may be at least partially circular, elliptical, parabolic, hyperbolic, exponential, convex or concave, such that a straight line connecting the end point of the contact plate 4 to the midpoint of the center curve forms an angle alpha with the tangent to the middle central curve. The alpha angle may range from 0.1 to 179, or from 0.2 to 170, or from 0.5 to 160, or from 1 to 150°.

The contact plate 4, the shape of which has at least two concave arcs with curvature k or has at least two concave inner corners of a polygonal structure, may be suitable for forehead treatment, similar to the T-shape 4.1 in FIG. 3A. The T-shape 4.1 can also be characterized by an arrangement of active elements 13, where the centers of at least two active elements 13 lie on one straight line, and the center of at least one additional element 13 lies on another line.

The contact plates can have different sizes with surface areas ranging from 0.1 to 150, or from 0.2 to 125, or from 0.5 to 100, or in the range from 1 to 50 cm ² . The contact plate may occupy approximately 1 to 99, or 1 to 80, or 1 to 60, or 1 to 50% of the surface. The number of active elements 13 in one contact plate 4 is in the range of 1 to 100, or 1 to 80, or 1 to 60, or 1 to 40. The thickness of at least a portion of the contact plate 4 may be in the range of 0. 01 to 15, or in the range from 0.02 to 10, or in the range from 0.05 to 7, or in the range from 0.1 to 7 cm.

In addition, the contact plates 4 can have a shape that at least partially follows the shape of such parts of the body as the tendon, the proud muscle, the levator labii superioris and ala nasi, the nasal muscle, the levator labii superioris muscle, the zygomatic minor muscle, zygomaticus major, levator anguli oris muscle, laughter muscle, subcutaneous neck muscle, depressor anguli oris muscle, depressor labii inferioris muscle, supracranial muscle (anterior belly), corrugator muscle, orbicularis oculi muscle, buccal muscle, masseter muscle , orbicularis oris or mentalis muscle when the contact plate 4 is attached to the surface of the patient's skin.

The contact plate 4 may be characterized by at least one of the above-mentioned aspects, or a combination of more than one of the above-mentioned aspects, or a combination of all of the above-mentioned aspects.

The electromagnetic energy generator 6 or the secondary generator 9 inside the main body can generate electromagnetic or secondary energy (eg, electric current), which can be delivered via a conductive lead to at least one active element 13 attached to the skin, respectively. The active element 13 can deliver energy over its entire surface or through a so-called fractional design. The active element 13 may comprise an active electrode in a monopolar, unipolar, bipolar or multipolar radio frequency system. In a monopolar RF 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 difference between the surface area of the active and neutral electrodes, energy is concentrated under the active electrode, allowing it to heat the area being treated. In a unipolar, bipolar, or multipolar RF system, there is no need for a neutral electrode 7. In a bipolar and multipolar RF system, energy is delivered between two or more active electrodes of similar surface area, respectively. The distance between these electrodes determines the depth of energy penetration. In a unipolar radiofrequency system, only one active electrode is embedded and energy is delivered to the tissue and environment surrounding the active electrode. The distance between the two closest active elements 13 (for example, the nearest adjacent sides of the electrodes) in one contact plate 4 may be in the range of 0.1 to 100, or in the range of 0.3 to 70, or in the range of 0.5 to 60 , or in the range from 1 to 50 mm.

In fig. 4 is a side view of a contact plate 4 configured for contact therapy. The contact plates 4 can be made of a flexible substrate material 42 - polyimide (PI) films, Teflon, epoxy resin or polyethylene foam with an additional adhesive layer 40 on the bottom side. They may have different shapes to allow the operator to select according to the area to be treated. The active elements 13 can have a contour of annular, semicircular, elliptical, oblong, square, rectangular, trapezoidal or polygonal shape with a surface area ranging from 0.1 to 70, or from 0.5 to 50, or from 1 to 25, or from 1 to 10 cm ² . The material used may be copper, aluminum, lead, or any other conductive medium that may be deposited or integrated into the contact plate. In addition, the active elements 13 (eg electrodes) can be made of silver, gold or graphite. The electrodes 13 in the contact plate 4 can be printed with biocompatible ink such as silver ink, graphite ink or a combination of inks from different conductors.

- 14 044406 basic materials.

The active element 13 (eg, an electrode providing a radio frequency field and/or an electric field) may be a full area electrode that has a fully active surface. This means that the entire patient-facing surface of the electrode can be made of a conductive material deposited or integrated into the contact plate 4, as mentioned above.

Alternatively, the patient-facing surface of the electrode 13 may be formed from a combination of a conductive material (eg, copper) and a non-conductive material (eg, dielectric material, insulating material, contact plate substrate, air, or hydrogel). Electrode 13 may include a frame of conductive material and, within the frame, may contain a combination of conductive and non-conductive materials. The frame may create an outer boundary of the electrode outline from a patient-facing side. The frame can be circular, semicircular, elliptical, oblong, square, rectangular, trapezoidal or polygonal in shape. A grid structure 802 may be located within the frame 801, as shown in FIG. 8A and 8B, with a non-conductive portion 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 greater than the thickness of the grid lines 802 by a value in the range of 1 to 2000, or in the range of 10 to 1000 , or in the range from 20 to 500, or in the range from 50 to 200%. Additionally, the frame 801 may be finer 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 0. 5 times to 2 times. It is also possible to design the electrode such that the thickness of the conductive material of the electrode decreases from the center 804 of the electrode 13, as shown in FIG. 8C. The thickness reduction increment between adjacent grid lines 802 away 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, the frame 801 having the thinnest line of conductive material. Alternatively, the electrode may not include a frame, for example it may be in the form of a grid without boundaries, as shown in FIG. 8D. The ratio of conductive material to non-conductive material of the electrode may be in the range of 1 to 99, or in the range of 5 to 95, or in the range of 10 to 90, or in the range of 20 to 80, or in the range of 30 to 70, or in range from 40 to 60%. Further, the ratio of conductive material to non-conductive material of the electrode may be in the range of 1 to 20, or in the range of 10 to 40, or in the range of 33 to 67, or in the range of 50 to 70, or in the range of 66 to 100%. Such a grid electrode can have many advantages. It can be much more flexible, it can provide improved contact with the patient, and it can have much better self-cooling than a full area electrode.

In cases where the active element 13 is in the form of a grid electrode, the energy flux of the grid electrode can be calculated as the energy flux of the grid 802 and/or frame 801 of the active element 13, and it may be in the range of 0.001 to 1500, or 0.01 to 1000. or from 0.5 to 500 W/ ^cm2 .

The active elements 13 may be partially enclosed in the flexible substrate layer 42 or the adhesive layer 40 or in the boundary between the flexible substrate layer 42 and the adhesive layer 40. The active elements 13 may be powered and controlled independently by multiple conductive terminals 41a, or they may be interconnected conductively way and be powered/controlled by one conductive terminal 41b. A plurality of conductive leads 41a may be connected to the active elements 13 via a free space (eg, an opening) in the flexible substrate layer 42. The free space (eg, hole) may be sized such that each conductive lead 41a may be closely packed within the substrate layer 42, for example, conductive lead 41a may be enclosed within the flexible substrate layer 42. In the case of connection via a single conductive terminal, the active elements 13 may be partially enclosed within the flexible substrate 42 or the adhesive layer 40 or in the boundary between the flexible substrate layer 42 and the adhesive layer 40, and the active elements 13 may be connected via a single conductive terminal 41b. which may be located in the flexible substrate 42 or at the interface between the flexible substrate 42 and the adhesive layer 40.

A single conductive terminal 41b may extend from the contact plate 4 on its side or top side in a direction away from the patient. In both cases, the conductive terminal 41a or 41b does not contact the treatment area.

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

The overall thickness of the contact plate at the narrower location may be in the range of 0.1 mm to 60 mm, or in the range of 0.5 to 50, or in the range of 0.7 to 40, or in the range of 1 to 30 mm.

Equipment made in the form of a fractional structure may have an active element 13 containing a matrix formed by active points of a certain size. These points are separated by inactive (and therefore untreatable) areas that allow tissue to heal faster. The surface containing hotspots can be from 1 to 99, or

- 15 044406 from 2 to 90, or from 3 to 80, or from 4 to 75% of the total area of the active element. The hotspots may have blunt ends on the tissue contacting side that do not penetrate the tissue, and the tissue contacting surface may have a surface area in the range of 500 to 250,000, or in the range of 1,000 to 200,000, or in the range of 200 to 180000, or in the range from 5000 to 160000 µm ² . The blunt end may have a radius of curvature of at least 0.05 mm. The diameter of the tissue-contacting surface of one active point may be in the range from 25 to 1500, or in the range from 50 to 1000, or in the range from 80 to 800, or in the range from 100 to 600 μm.

Additionally, the device can use a safety system containing temperature sensors and a circuit capable of adjusting therapy parameters based on the measured values. One or more temperature sensors, depending on the number and distribution of active elements 13, can be integrated on the contact plate 4 to collect data from different points to ensure heating uniformity. Data can be collected directly from the treatment area or from the active elements 13. If uneven heating or excessive heating 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 may be adjusted. The main parameters of therapy are power, duty cycle, a period of time that regulates switching between several active elements 13. Therapy can be automatically stopped if the temperature rises above a safe threshold value.

In addition, impedance measurement may be implemented to monitor proper contact of the active element 13 with the skin. If the impedance value is outside the permitted limits, therapy can be automatically suspended and the operator can be notified of potential contact problems.

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

In fig. Figure 5 shows some approaches to delivering contact therapy equipment.

It is possible to switch between multiple active elements 13 in a single contact plate 4 such that multiple active elements 13 deliver energy simultaneously, sequentially, or in an overlapping manner, or in any combination thereof. For example, in the case of two active elements: in the simultaneous method, both active elements are used simultaneously for a time interval, for example, 1-20 s. In the sequential method, the first active element is used during the first time interval, for example, from 1 to 10 s. The first active element is then stopped and the second active element is immediately used in a subsequent time interval, for example, from 10 to 20 seconds. This sequential step can be repeated. In the overlapping method, the first active element is used during a time interval of, for example, 1-10 s, and the second active element is used during a second overlapping time interval, for example, 1-10 s, while during the second time interval, the first the active element and the second active element overlap, for example, the total time of the overlapping method is 0.1-9.9 s. The active elements 13 can deliver energy sequentially in a predetermined switching order or in a random manner as specified by the operator via the human-machine interface 8. Circuit I in FIG. 5 represents switching between pairs/groups formed of non-adjacent active elements 13 located within the contact plate 4. Each pair/group of active elements 13 delivers energy for a predetermined period of time (dark gray elements in FIG. 5 - in diagram I elements 1 and 3), while the remaining pairs/groups of active elements 13 remain inactive in relation to energy delivery (light gray elements in Fig. 5 - elements 2 and 4 in diagram I). After a predetermined period of time, another pair/group of active elements 13 delivers energy and the original active elements become inactive. This is indicated by arrows in Fig. 5. Switching between pairs/groups of active elements 13 may continue until the target temperature is reached over the entire treatment area or until a predetermined energy is delivered by all active elements 13. Circuit II in FIG. 5 represents the switching of all active elements 13 in the contact plate 4 between an ON state when the active elements are delivering energy and an OFF state when they are not delivering energy. The duration of the ON and OFF states may vary depending on predefined settings and/or information provided by sensors, such as temperature sensors. Scheme III in Fig. 5 shows the sequential switching of individual active elements 13 in the contact plate 4. Each active element 13 delivers energy for predetermined periods of time until the target temperature is reached over the entire treatment area or until the predetermined energy is delivered by all active elements 13. This sequential switching can be done clockwise or counterclockwise. Scheme IV in Fig. 5 represents a zigzag switching order during which preferably non-adjacent active elements 13 successively deliver energy until all active elements 13 in the contact plate 4 are switched to the ON state. Each active element 13 delivers energy for a predetermined period of time until the target temperature is reached over the entire treatment area or until the predetermined energy is delivered by all active elements.

The CPU may be configured to control the stimulating device and provide treatment through at least one treatment protocol to improve appearance. The treatment protocol is a set of parameters of primary electromagnetic energy and secondary energy that provide the required treatment effect. Each contact plate can be controlled to provide the same protocol or alternatively different protocols. Pairs of areas or areas where a symmetrical effect is desired can be treated using the same treatment protocol. Each protocol may include one or more stages or steps.

As a non-limiting example, in the case of supplying RF energy to the active elements one at a time, as shown in circuits III and IV of FIG. 5, the time for one active element to deliver radiofrequency energy to the patient's tissue 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 elements in series can be switched ON and OFF in a sequential or overlapping manner. Additionally, delivery of radiofrequency energy by two sequential active elements can be separated in time by periods of no RF stimulation or low RF stimulation such that neither of the two sequential active elements provides RF heating to the tissue being treated. The duration of periods without radiofrequency stimulation or with low radiofrequency stimulation can be in the range from 1 μs to 1000 ms, or in the range from 500 μs to 500 ms, or in the range from 1 ms to 300 ms, or in the range from 10 ms to 250 ms .

In the case of treatment using more than one contact plate, sequential switching of the active elements providing radiofrequency treatment can be provided in each contact plate independently of the other contact plates, or the active elements can deliver energy sequentially across all contact plates.

As an example for three dependent contact plates, each containing two active elements:

the first stage - the radio frequency can be provided by the first active element in the first contact plate, while the other active elements are turned off, the second stage - the second active element of the first contact plate is turned on, and the remaining active elements are turned off, the third stage - the first active element of the second contact plate is turned on, and the remaining active elements are turned off, the fourth stage - the second active element of the second contact plate is turned on, and the remaining active elements are turned off, the fifth stage - the first active element of the third contact plate is turned on, and the remaining active elements are turned off, the sixth stage - the second active element of the third contact plate is turned on , and the remaining active elements are turned off.

Another non-limiting example may be the following:

the first stage - the radio frequency can be provided by the first active element in the first contact plate, while the other active elements are turned off, the second stage - the first active element of the second contact plate is turned on, and the remaining active elements are turned off, the third stage - the first active element of the third contact plate is turned on, and the remaining active elements are turned off, the fourth stage - the second active element of the first contact plate is turned on, and the remaining active elements are turned off, the fifth stage - the second active element of the second contact plate is turned on, and the remaining active elements are turned off, the sixth stage - the second active element of the third contact plate is turned on , and the remaining active elements are turned off.

In the case where contact plates are treating paired areas (eg cheeks, thighs or buttocks) where a symmetrical effect is required, a pair of contact plates can be actuated with the same protocol at the same time.

An example treatment protocol for a single contact plate delivering radiofrequency energy to heat the patient and electrical current to induce muscle contractions is described below. The protocol may include a first stage where the treatment with electrodes in a single contact plate may be such that the electrodes provide electrical current pulses modulated in an increasing amplitude modulation envelope (increasing envelope) followed by a constant amplitude (rectangular envelope) , followed by a decreasing amplitude modulation (decreasing envelope), all three of these envelopes together can create a trapezoidal amplitude modulation (trapezoidal envelope). The trapezoidal envelope can last from 1 to 10, or from 1.5 to 7, or from 2 to 5 s. An increasing rectangular or decreasing envelope can last from 0.1 to 5, or from 0.1 to 4, or from 0.1 to 3 s. The ascending and descending envelopes can have the same duration, thereby creating a symmetrical trapezoidal envelope. Alternatively, the electrical current may be modulated into a sinusoidal envelope, or a rectangular envelope, or a triangular envelope. The corresponding envelopes that cause muscle contraction can be separated by a period without current stimulation or with low current stimulation so that no muscle contraction occurs, or by radiofrequency energy that causes heating of the tissue. During this period, without muscle contraction, the suction holes can provide massaging pressure, which can lead to muscle relaxation. The first stage can be pre-programmed such that electrodes at different locations on the contact plate can be switched in time to provide AC pulses, while several other electrodes in the contact plate may not provide any AC pulses but only RF pulses causing heating the fabric. All electrodes in the contact plate can be guaranteed to provide (switched by switching circuit 14 to provide) RF pulses for tissue heating during the protocol stage or during the protocol, while only a limited number of electrodes can provide (switched by switching circuit 14 to provide) variables currents for muscle contraction during the protocol stage or during the protocol. The device can be designed in such a way that the first stage lasts 1-5 minutes.

The second stage may follow the first stage. The second stage can be pre-programmed in such a way that electrodes different from those used in the first stage at different places on the contact plate can be switched in time to provide alternating current pulses, while several other electrodes (the same electrodes used in the first stages, or other electrodes) in the contact plate may not provide any AC pulses, but only RF pulses that cause heating of the tissue.

The third stage may follow the second stage. The third stage can be pre-programmed in such a way that electrodes different from those used in the second stage at different places on the contact plate can be switched in time to provide alternating current pulses, while several other electrodes (the same electrodes used in the second stages, or other electrodes) in the contact plate may not provide any AC pulses, but only RF pulses that cause heating of the tissue.

The protocol can be pre-programmed so that the electrodes that provide the electrical current that causes muscle contractions are switched to provide radiofrequency heating after they have generated a maximum of one, two, three, four or five contractions.

The corresponding stages are assembled by the control unit (CPU) into a treatment protocol to provide at least 60-900, or 90-800, or 150-700 contractions using one contact plate.

The forehead contact plate may include an electrode arrangement such that anatomical area 1 and anatomical area 2 are stimulated by alternating currents that can cause muscle contractions, while anatomical area 3 is not stimulated by alternating currents that cause muscle contractions. The control unit (CPU) is configured to provide a treatment protocol that delivers alternating electrical currents only to those electrodes that are located near or above the anatomical regions 1 and 2; and applies only the radio frequency signal to the electrode/electrodes near or above the anatomical region 3, as shown in FIG. 9. Anatomical regions 1 and 2 may contain the frontalis muscles, and anatomical region 3 may contain the center of the proud muscle.

A contact plate used to treat the cheek (either side of the face below the eye) may include an electrode arrangement such that an anatomical area containing the buccal muscle, masseter muscle, zygomatic muscle, or laughter muscle is stimulated by electrical currents that can cause muscle contractions, in while other anatomical areas can only be heated by radiofrequency energy.

Conversely, the contact plate may be configured such that an electrode arrangement near the eyes (eg, a body part containing the orbicularis oculi muscles) or teeth (eg, a body part containing the orbicularis oris muscles) may not provide energy to cause muscle contractions.

The treatment device may be configured such that, at each stage or stage, the impedance sensor provides information to the CPU about the contact of the contact plate or active element with the patient. The CPU can determine, based on predetermined conditions, whether the contact of the contact plate or the active element with the patient is sufficient or not. If there is sufficient contact, the CPU may allow the treatment protocol to continue. In case of insufficient contact, the evaluated contact plate or active element is switched off and the treatment protocol continues on the subsequent contact plate or active element, or the treatment is stopped. The determination of sufficient contact of the contact plate or active element can be displayed on the human-machine interface 8.

Impedance measurement can be performed at the beginning of a stage/stage, during a stage/stage, or at the end of a stage/stage. The impedance measurement and/or assessment of sufficient contact may be determined only on the active electrodes for a given stage/stage or may be performed on all electrodes of all contact plates used during the stage/stage.

Fig. 6 and fig. 7 are considered together. In fig. 6 shows a block diagram of non-contact therapy equipment 100. In fig. 7 is an illustration of non-contact therapy equipment 100. The non-contact therapy equipment 100 may comprise two main units: a main assembly 2 and a delivery head 19, interconnected by a fixed or adjustable arm 21.

The main assembly 2 may include an electromagnetic generator 6 that can generate one or more forms of electromagnetic radiation, wherein the electromagnetic radiation may be, for example, in the form of incoherent light or in the form of coherent light (eg, laser light) of a predetermined wavelength. The electromagnetic field can mainly be generated by a laser, laser diode module, LED, flash lamp or incandescent light bulb. The electromagnetic radiation may be such that it may be at least partially absorbed beneath the surface of the patient's skin. The wavelength of the supplied radiation may be in the range of 100 to 15,000 nm, or in the range of 200 to 12,000, or in the range of 300 to 11,000, or in the range of 400 to 10,600 nm, or it may be in the form of a second, third, fourth, the fifth, sixth, seventh or eighth harmonic wavelengths of the above wavelength ranges. The main node 2 may further include a human-machine interface 8, represented by a display, buttons, keyboard, touchpad, touchpad or other controls that allow the operator to check and adjust therapy parameters and other device parameters. The power source 5 located in the main assembly may include a transformer, a disposable battery, a rechargeable battery, a power connector, or a standard power cable. The output power of the power supply 5 may be in the range of 10 to 600, or in the range of 50 to 500, or in the range of 80 to 450 W. The indicators 17 may independently provide additional information about the current state of the device at the human-machine interface 8. The indicators 17 may be implemented through a display, LEDs, beeps, vibrations, or other forms capable of providing a sufficient message.

The delivery head 19 may be interconnected with the main assembly by means of a bracket 21, which may form the main optical and electrical path. The bracket 21 may contain transmission media, such as wires or a waveguide, such as mirrors or fiber optic cables, for electromagnetic radiation in the form of light or additional electrical signals needed to power the head 19 for delivery. CPU 11 controls an electromagnetic generator 6, which can generate continuous electromagnetic energy (EM) or pulses having an integrated flux density in the range from 0.1 pJ/cm ² to 1000 J/cm ² , or in the range from 0.5 pJ/cm ² to 800 J/cm ² , or in the range from 0.8 pJ/cm ² to 700 J/cm ² , or in the range from 1 pJ/cm ² to 600 J/cm ² at the output of the electromagnetic generator. The SM mode can be operated for a time interval in the range from 0.1 s to 24 h, or in the range from 0.2 s to 12 h, or in the range from 0.5 s to 6 h, or in the range from 1 s to 3 hours. The duration of the electromagnetic radiation pulse used in the pulse mode can be in the range from 0.1 fs to 2000 ms, or in the range from 0.5 fs to 1500 ms, or in the range from 1 fs to 1200 ms, or in range from 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 pulse mode can be operated by CPU 11 in single pulse mode, or in repeat mode, or in batch mode. The frequency of repeat mode or burst mode can be in the range of 0.05 to 10000 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 repetition mode or burst mode frequency 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 of 1 kHz up to 80 MHz. The single pulse mode may be configured to generate one type of electromagnetic energy with specific parameters (eg, intensity, duration, etc.) to irradiate one treatment area. The repetition mode may be configured to generate electromagnetic energy, which may have one or more specific parameters (eg, intensity, duration, etc.), at the aforementioned pulse repetition rate to irradiate one treatment area. The burst mode may be configured to generate multiple sequential electromagnetic energies, which may have variable parameters (e.g., intensity, duration, delay, etc.), during a single sequence, wherein the sequences are repeated at the aforementioned frequency, and wherein the sequence may involve the same or different sets of successive electromagnetic energies.

Alternatively, the device may include more than one electromagnetic generator 6 for generating the same or different electromagnetic energies, for example, one electromagnetic generator is designed to generate ablative electromagnetic energy and another is designed to generate non-ablative electromagnetic energy. In this case, the operator can select which electromagnetic generators can be used for a given treatment, or the physician consultant can select the desired treatment through the human-machine interface 8, and the CPU 11 will select the electromagnetic generators to be used. It is possible to use one or more electromagnetic generators of device 100 simultaneously, in series, or in an overlapping manner. For example, in the case of two electromagnetic generators: in the simultaneous method, both electromagnetic generators are used simultaneously for a time interval of, for example, 1-20 ps. In the sequential method, the first electromagnetic generator is used during the first time interval, for example, from 1 to 10 ps. The first electromagnetic generator is then stopped and the second electromagnetic generator is immediately used in a subsequent time interval, for example, from 10 to 20 ps. This sequence of two or more successive steps may be repeated. In the overlapping method, the first electromagnetic generator is used for a time interval of, 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 is overlapped, for example, the total time of the overlapped method is 2-10 ps. In the case of more than two electromagnetic generators, activating and deactivating the electromagnetic generators in a sequential or overlapping manner may be performed by the CPU 11 in an order that is appropriate for a given treatment, for example, first activating the preheat electromagnetic generator, then the ablative electromagnetic generator, and then the non-ablative electromagnetic generator.

The active elements 13 in the delivery head 19 may take the form of optical elements, which may be one or more optical windows, lenses, mirrors, fibers or refractive elements. The optical element representing the active element 13 may be connected to or contain an electromagnetic generator 6 within the delivery head 19. The optical element may produce a single beam of electromagnetic energy, which may provide an energy irradiation site having an energy irradiation site size defined as the surface of the tissue irradiated by a single beam of light. One light generator may provide one or more energy sites, for example by dividing a single beam into multiple beams. The size of the energy impact area may be in the range of 0.001 to 1000, or in the range of 0.005 to 700, or in the range of 0.01 to 300, or in the range of 0.03 to 80 cm ² . Areas of exposure to energy of different or the same wavelength may be superimposed on each other or may be separated. Two or more light beams can be applied to the same area at the same time or with a time interval ranging from 0.1 μs to 30 s. The energy impact areas may be separated by a distance equal to at least 1% of their diameter, and further, the energy impact areas may be located close to each other or may be separated by a gap in the range of 0.01 to 20, or 0. 05 to 15, or from 0.1 to 10 mm.

The CPU 11 may further provide switching between active elements 13 or movement of active elements 13 within the delivery head 19 so that electromagnetic radiation can be uniformly delivered to the entire treatment area marked by the guide beam 18. The intensity of switching between active elements 13 may depend on the amount of delivered energy, pulse length, etc., as well as the speed of the CPU 11 or other mechanism that switches or moves the active elements 13 (for example, a scanning device). Additionally, the device may be configured to switch between multiple active elements 13 such that they deliver energy simultaneously, sequentially, or in an overlapping manner. For example, in the case of two active elements: in the simultaneous method, both active elements are used simultaneously over a time interval, for example, 1-20 ps. In the sequential method, the first active element is used during the first time interval, for example, from 1 to 10 ps. The first active element is then stopped and the second active element is immediately used in a subsequent time interval, for example, from 10 to 20 ps. This sequential step can be repeated. In the overlapping method, the first active element is used during a time interval for, for example, 1-10 ps, and the second active element is used in 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, the total time of the overlapping method is 2-10 ps.

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

In addition, the contact plate may include a distance sensor 22 driven by the CPU 11 to measure the distance from the active element 13 to a treatment point in the treatment area marked by the guide beam 18. The CPU 11 may use the measured value as a parameter for adjusting one or more treatment parameters that may depend on the distance between the electromagnetic generator and the point being treated, for example, integral flux density. Information from the distance sensor 22 may be provided to the CPU 11 before each switch/movement of the active element 13 so that the delivered energy remains the same throughout the treatment area, regardless of its shape or unevenness.

The patient's skin may be pre-cooled to a selected temperature for a selected duration in at least one portion being treated, wherein the selected temperature and pre-cooling duration are preferably sufficient to cool the skin to at least a selected temperature that is lower than normal body temperature. The skin may be cooled to at least a selected temperature to a depth greater than at least one depth for the portions being treated such that at least one portion being treated is substantially surrounded by cooled skin. Cooling may continue during the application of radiation, and the duration of application of radiation may be longer than the thermal relaxation time of the parts being treated. Cooling may be provided by any known mechanism, including water cooling, atomized coolant, an active solid cooling element (eg, a thermoelectric cooler), or air flow cooling. The cooling element may function as an optical element. Alternatively, the separator can function as a cooling element. Cooling can be provided during, before or after treatment using electromagnetic energy. Cooling before treatment may also provide an environment for sudden heat shock, while cooling after treatment may provide accelerated regeneration after heat shock. The refrigerant temperature can range from -200 to 36°C. The temperature of the cooling element during treatment can range from -80 to 36, or from -70 to 35, or from -60 to 34°C. Additionally, if the contact plate is not in contact with the patient's skin, cryogenic spray cooling, gas flow cooling, or other non-contact cooling techniques may be used. A cooling gel on the surface of the skin may also be used in addition to or instead of one of the cooling techniques mentioned above.

Additionally, device 100 may include one or more sensors. The sensor may provide information about at least one physical quantity, and its measurement may produce feedback that may be displayed by the human-machine interface 8 or indicators 17. The one or more sensors may be used to detect various physical quantities, including, but not limited to , energy of delivered electromagnetic radiation or backscattered electromagnetic radiation from the skin, skin impedance, skin impedance, temperature of treated skin, temperature of untreated skin, temperature of at least one layer of skin, water content of the device, phase angle of delivered or reflected energy, the position of the active elements 13, the position of the delivery element 19, the temperature of the cooling medium or the temperature of the electromagnetic generator 6. The sensor may be a temperature sensor, a sound sensor, a vibration sensor, an electrical sensor, a magnetic sensor, a flow sensor, a position sensor, an optical sensor, an image sensor, pressure sensor, force sensor, energy flow sensor, impedance sensor, current sensor, Hall sensor or proximity sensor. The sensor may be a capacitive displacement sensor, an audio proximity sensor, a gyroscope, an accelerometer, a magnetometer, an infrared camera, or a thermographic camera. The sensor may be invasive or non-contact. The sensor may be located on the delivery element 19 or the main assembly 2 or may be part of the distance sensor 22 . One sensor can measure more than one physical quantity. For example, the sensor may comprise 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 skin being treated. The CPU 11 can analyze the temperature. The temperature sensor may be a non-contact sensor (for example, an infrared temperature sensor). The CPU 11 may also use algorithms to calculate the temperature below the surface of the skin based on the surface temperature of the skin and one or more additional parameters. A closed-loop temperature control system may control the temperature and, based on preset or preset limits, alert the operator in a human-perceivable form, for example, through a human-machine interface 8 or indicators 17. In a temperature-limited condition, the device may be configured to adjust treatment parameters for each active element, such as power output, cooling activation or treatment stop. The human-perceivable form may be a sound, a warning message displayed on the human-machine interface 8 or indicators 17, or a color change of any part of the device 100.

The resistance sensor can measure skin resistance, as it may vary between patients, as well as moisture; hydration and sweat can affect the resistance and therefore the behavior of the skin in the energy field. Based on the measured skin resistance, the total skin resistance can also be calculated.

Information from one or more sensors may be used to generate a trajectory on a convenient model, for example, a model of the human body shown on the display of the human-machine interface 8. The trajectory may represent the surface or volume of tissue that has already been treated, tissue that is currently being treated, tissue, which is to be treated, or tissue that is not treated. A convenient model can display a temperature map of the tissue being treated, providing information about tissue that has already been treated or tissue that is not being treated.

The sensor can provide information about the location of bones, inflamed tissue or joints. These types of tissue may not be targeted by electromagnetic radiation due to the potential for pain during treatment. Bones, joints or inflamed tissue can be detected by any type of sensor such as an image sensor (ultrasonic sensor, IR sensor), impedance sensor, etc. Detection of the presence of these types of tissue may cause the creation of signals normally perceived by humans or the interruption of the generation of electromagnetic radiation. Bones can be detected, for example, by changes in tissue impedance or by analyzing reflected electromagnetic radiation.

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

As part of the present invention, the treatment method includes the following steps: tissue preparation; placement of the proposed device; selecting or setting treatment parameters; and energy supply. More than one stage can be executed simultaneously.

Tissue preparation may include removing makeup or cleaning the patient's skin. For higher target temperatures, anesthesia may be applied topically or by injection.

Placement of the device may involve selecting the correct shape of the contact plate to match the area to be treated and attaching the contact plate or neutral electrode to the patient, for example, using an adhesive layer, vacuum suction, tape or mask, and ensuring proper contact with the area being treated tissue in case of contact therapy. In the case of non-contact therapy, placement of the device may include adjusting the aiming beam of the proposed device such that the device can measure the distance from the active element(s) to the treatment area and adjust treatment parameters accordingly.

Selection or setting of treatment parameters may include adjustment of treatment duration, power, duty cycle, delivery time and mode (CM or pulse), surface density/spot size for fractional design, and mode of operation. Selecting a mode of operation may mean selecting a simultaneous, sequential or overlapping method, or selecting the order in which active elements or groups of active elements switch, or selecting a suitable preprogrammed protocol.

Supplying energy may include providing at least one type of energy in the form of RF energy, ultrasonic energy, or electromagnetic energy in the form of polychromatic or monochromatic light, or a combination thereof. Energy can be provided from at least one active element to the skin using the proposed device. Energy can be delivered and regulated automatically by the CPU according to information from temperature sensors, and impedance measurements, and, in the case of non-contact therapy, distance sensors. All automatic adjustments and potential effects on therapy can be indicated on the device display. The operator or patient can pause therapy at any time during treatment. A typical treatment may have a duration of from about 1 to 60, or from 2 to 50, or from 3 to 40 minutes per contact plate, depending on the area being treated and the size and number of active elements located in the contact plate.

In one example, delivering energy to tissue may include providing radiofrequency energy,

-

Claims (24)

or ultrasonic energy, or a combination thereof, from active elements built into the contact plate to the patient's skin. In such a case, the active elements providing the RF energy may be dielectric and capacitive or resistive RF electrodes, and the RF energy may result in heating, coagulation, or ablation of the skin. Ultrasonic energy can be provided through an acoustic window and can increase the temperature at some depth, which can suppress the RF energy loss associated with the differential, and thus the required temperature in the nucleation layer can be achieved. In addition, the RF electrode can act as an acoustic window for ultrasonic energy. Alternatively, delivering energy to the tissue may include delivering electromagnetic energy in the form of polychromatic or monochromatic light from the active elements to the patient's skin. In this case, the active elements providing electromagnetic energy may contain optical elements described in the proposed device. The optical elements may be an optical window, lens, mirror, fiber, or electromagnetic field generator, such as an LED, laser, flash tube, incandescent light bulb, or other light sources known in the art. Electromagnetic energy in the form of polychromatic or monochromatic light can result in heating, coagulation, or ablation of the skin in the treated area. Once the desired temperature and duration of therapy have been reached, the therapy is stopped, the device accessories can be removed, and the patient's skin can be cleaned. CLAIM 1. A device for improving the appearance of a patient, the device comprising: a radio frequency generator configured to generate radio frequency energy; an electric current generator configured to generate a pulsed electric current; switch; a contact plate comprising a plurality of electrodes, the plurality of electrodes including a plurality of radiofrequency electrodes and a pair of electrotherapy electrodes, wherein the contact plate and the plurality of electrodes are configured to be attached to a body part of a patient during treatment; and a control unit configured to control a radio frequency generator, an electric current generator, and a switch, wherein the plurality of radio frequency electrodes are configured to supply radio frequency energy with a frequency in the range of 400 kHz to 80 MHz to the patient's body part, causing the skin of the body part to be heated to a temperature in the range from 37.5 to 65°C, while the pair of electrodes for electrotherapy is configured to supply a pulsed electric current with a pulse duration in the range from 0.1 μs to 10 s and a frequency in the range from 0.1 Hz to 12 kHz body part, providing electrical stimulation to a muscle on the body part, wherein the distance between a pair of electrotherapy electrodes is in the range of 0.1 mm to 4 cm, wherein the muscle on the body part includes at least one of a frontalis muscle, a buccal muscle, a masseter muscle, zygomaticus muscle or laughter muscle, and wherein the contact plate is configured to provide radiofrequency heating and electrical stimulation of the muscle to improve the appearance of the patient. 2. The device according to claim 1, characterized in that the pulsed electric current is modulated in amplitude, creating a trapezoidal envelope. 3. The device according to claim 2, characterized in that the trapezoidal envelope is a symmetrical trapezoidal envelope with a duration ranging from 1 to 10 s. 4. The device according to any one of claims 1 to 3, characterized in that the contact plate is configured to provide radio frequency energy and electrical current in an overlapping manner for at least a subset of the treatment duration. 5. The device according to any one of claims 1 to 4, characterized in that the radio frequency energy is provided sequentially by the first and second radio frequency electrodes of several radio frequency electrodes, and the provision of radio frequency energy by the first and second radio frequency electrodes is separated by a length of time during which there is no radio frequency energy, in the range from 1 µs to 1000 ms. 6. The device according to any one of claims 1 to 5, characterized in that several radio frequency electrodes provide radio frequency energy in the form of pulses with a pulse duration ranging from 0.1 ms to 10 s. 7. A device for treating a patient, the device comprising: a radio frequency generator configured to generate radio frequency energy; - 23 044406 electric current generator, configured to generate pulsed electric current; switch; a contact plate comprising a radiofrequency electrode and an electrotherapy electrode, wherein the contact plate is flexible, wherein the contact plate is configured to be attached to at least one of the patient's face, submentum or neck during treatment, wherein the radiofrequency electrode is capable of delivering radiofrequency energy with a frequency in the range of 400 kHz to 80 MHz to at least one of the face, submentum or neck, providing radiofrequency heating of the skin of at least one of the face, submentum or neck to a temperature in the range of 37.5 to 65°C and wherein the electrotherapy electrode is configured to apply a pulsed electrical current with a pulse duration in the range of 0.5 μs to 500 ms to at least one of the face, submentum or neck, causing contraction of a muscle on at least one of the face, submentum or neck; and a control unit configured to control the radio frequency generator, electric current generator or switch, wherein the control unit comprises a central processing unit or microprocessor, and wherein the control unit is configured to control the contact plate to provide radio frequency energy and pulsed electrical current during treatment. 8. The device according to claim 7, characterized in that the pulsed electric current is an alternating current with a frequency in the range from 0.5 Hz to 1 kHz. 9. The device according to claim 7 or 8, characterized in that the control unit modulates the amplitude of the pulsed electric current, creating a trapezoidal envelope containing increasing, constant and decreasing parts, while the duration of the increasing or decreasing part of the trapezoidal envelope is in the range of 0.1 up to 5 s. 10. The device according to any one of claims 7-9, characterized in that it further comprises an impedance sensor configured to obtain information indicating contact of the contact plate, radiofrequency electrode or electrotherapy electrode with the patient, wherein the impedance sensor is configured with the ability to provide contact information to the control node. 11. The device of claim 10, further comprising a user interface, wherein the control unit further comprises a pre-programmed treatment protocol, and wherein the user interface is configured to allow the user of the device to select a pre-programmed treatment protocol. 12. The device according to claim 11, characterized in that the treatment protocol contains stages, wherein each stage contains a plurality of parameters of radio frequency energy and pulsed electrical current, and wherein the impedance sensor is configured to provide contact information to the control unit at each stage pre-programmed treatment protocol. 13. The device according to claim 11 or 12, characterized in that the treatment protocol is designed to cause from 60 to 900 contractions using a contact plate during treatment. 14. A device according to any one of claims 7 to 13, characterized in that the contact plate is configured to cause contractions in at least one muscle of the frontalis muscle, the buccal muscle, the masseter muscle, the zygomatic muscle or the laughter muscle. 15. A device for treating a patient, the device comprising: radio frequency energy generator; electric current generator; switch; a contact plate comprising a flexible substrate, a flexible electrode and a conductive lead for connecting the flexible electrode to a radio frequency energy generator and an electric current generator, wherein the flexible electrode is located on the underside of the flexible substrate, wherein the contact plate is flexible and configured to adapt to parts of the patient's body, wherein the underside of the flexible substrate and the flexible electrode are configured to be attached to the body part, and wherein the flexible electrode is in contact with the body part during treatment; and a control unit containing a control processor or microprocessor, wherein the control unit is configured to control a switch, a radio frequency energy generator and an electric current generator, wherein the flexible electrode is configured to supply radio frequency energy with a frequency of - 24 044406 in the range from 400 kHz to 80 MHz to a part of the body, providing radio frequency heating of the skin of the body part to a temperature in the range from 37.5 to 65 ° C, while the flexible electrode is configured to supply a pulsed electric current with a pulse duration in the range from 0.1 μs to 10 s and a frequency in the range of 0.1 Hz to 12 kHz to a part of the body, providing muscle contraction on a part of the body, wherein the part of the body is the face, submentum or neck, and wherein the flexible electrode is configured to delivering radiofrequency energy and pulsed electrical current during treatment. 16. The device according to claim 15, characterized in that the conductive terminal is located on the upper side of the contact plate and is connected to the flexible electrode through an opening in the flexible substrate, which is located above the flexible electrode. 17. The device of claim 15 or 16, wherein the contact plate further comprises adhesive on the underside of the flexible substrate, wherein the flexible electrode is partially immersed in the adhesive, and wherein the contact plate is secured to the body part by the adhesive. 18. The device according to claim 17, characterized in that the glue is a mixture containing water or adhesive tape. 19. The device according to claim 18, characterized in that the adhesive additionally contains a polyol component. 20. The device according to claim 18 or 19, characterized in that the total resistance of the adhesive is higher than the total resistance of the skin by a factor that is in the range from 1.1 to 20 times. 21. The device according to any one of claims 17 to 20, characterized in that the contact plate further comprises a sticker adhered to the upper side of the flexible substrate, and the lower side of the sticker contains an adhesive layer configured to provide additional fixation of the contact plate to the body part patient. 22. The device according to claim 21, characterized in that the sticker is of such a size that it extends beyond the edge of the contact plate by a value in the range from 0.1 to 10 cm. 23. The device according to any one of claims 15 to 22, characterized in that the contact plate has a thickness in the range from 0.1 to 60 mm, and the flexible substrate contains at least one of a polymer-based material, a polyimide film, polytetrafluoroethylene , epoxy resin, polyethylene terephthalate, polyamide, polyethylene foam, silicone-based material or fabric. 24. A device for improving the appearance of a patient, the device comprising: radio frequency energy generator; electric current generator; switch; several conductive leads; a flexible contact plate comprising a flexible substrate and a plurality of electrodes, the plurality of electrodes including a radiofrequency electrode and a pair of electrotherapy electrodes, the plurality of electrodes located on an underside of the flexible substrate, wherein each electrode of the plurality of electrodes is connected to a corresponding conductive terminal of the plurality of electrodes conductive terminals, wherein the plurality of conductive terminals are configured to connect multiple electrodes to the switch, and wherein the switch is configured to connect the multiple conductive terminals to a radio frequency energy generator or electric current generator, wherein the contact plate is flexible and adaptable to the part the patient's body, wherein the underside of the flexible substrate and the plurality of electrodes are configured to be attached to a body part, and wherein the plurality of electrodes are in contact with the body part during treatment; and a control unit comprising a control processor or microprocessor, wherein the control unit is configured to control the switch, the radio frequency generator, and the electric current generator, wherein the radio frequency electrode is configured to supply radio frequency energy with a frequency in the range of 400 kHz to 80 MHz to the body part, providing radiofrequency heating of the skin of a body part in the range from 37.5 to 65°C, while a pair of electrodes for electrotherapy is configured to supply a pulsed electric current with a pulse duration in the range from 0.1 μs to 10 s and a frequency in the range from 0, 1 Hz to 12 kHz to a body part, providing muscle contraction to a body part, where the distance between a pair of electrotherapy electrodes is in the range of 0.1 mm to 4 cm, where the body part is the face, submentum or neck, and -