Device for the unattended treatment of the patient

Abstract

Device for treating a patient, comprising: a first generator designed to produce high-frequency energy; an applicator designed to be attached to a part of a patient's body, wherein the applicator has: a connector designed to connect the applicator to the first generator; and a pad with at least one active element that can be attached to a treatment area of ​​the body part and is designed to deliver the high-frequency energy of the first generator to the treatment area; a control unit with one or more pre-programmed protocols; wherein the control unit is designed to control the first generator and deliver the high-frequency energy to the treatment area according to one or more pre-programmed protocols.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of now-pending U.S. application 17 / 664,161, filed May 19, 2022, which is a continuation-in-part of now-pending U.S. application 17 / 518,243, filed November 3, 2021, which is a continuation-in-part of now-pending International Application No. PCT / IB2021 / 00300, filed May 3, 2021, claiming priority to U.S. Provisional Application No. 63 / 019,619, filed May 4, 2020, all of which are incorporated herein by reference in their entirety. FIELD OF THE INVENTION

[0002] The present invention relates to methods and devices for treating patients by means of active elements that emit electromagnetic energy and / or secondary energy in such a way that the treatment area is treated homogeneously without the active elements having to be manipulated during therapy. GENERAL STATE OF THE ART

[0003] Skin ages over time, primarily due to UV exposure—a process known as photoaging. Daily exposure to UV light gradually leads to a reduction in skin thickness and a lower amount of the skin's basic building proteins—collagen and elastin. A third important skin component, hyaluronic acid, is also reduced. These changes occur more rapidly in visible areas of the body, especially the face. Various technologies are available for non-invasive facial skin rejuvenation, including lasers, high-intensity focused ultrasound, and radiofrequency. Ultrasound and RF fields are also expected to increase hyaluronic acid levels in the dermis.

[0004] In the past, the delivery of various forms of electromagnetic energy to patients was widely used for medical and cosmetic purposes. These common procedures for improving visual appearance include, but are not limited to, skin rejuvenation, wrinkle removal, wrinkle smoothing, skin tightening and lifting, cellulite and fat reduction, treatment of pigmented lesions, tattoo removal, soft tissue coagulation and ablation, reduction of vascular lesions, facelifts, muscle contractions and strengthening, temporary relief of pain, muscle spasms, improvement of local circulation, etc.

[0005] Despite the many undeniable benefits of heat therapy, these procedures also carry certain limitations and associated risks. Among other things, the reproducibility of results is limited, as these depend largely on the treatment techniques used and the skill of the practitioner. Furthermore, improperly performed therapy carries an increased risk of burns and adverse events.

[0006] It is very difficult to ensure homogeneous energy distribution when energy delivery is controlled by manual movement of the operator's hand, which is the most common procedure. Certain areas can easily be over- or under-treated. For this reason, devices incorporating scanning or other mechanisms that allow uncontrolled delivery to the skin have emerged. These devices typically deliver energy without direct contact with the treated area and only to a limited, well-defined area with no visible inequality. Maintaining the same distance between the treated tissue and the energy generator or maintaining the required tissue contact can be challenging when treating uneven or rough areas.Therefore, the use of commonly available devices on such specific areas, which also vary from patient to patient (e.g., the face), is practically impossible.

[0007] In addition to the complications arising from application to rough areas and the need to adapt to the contours of different patients, unattended application on the face is also specified by the increased need for protection against burns and other adverse effects. Although the face heals more easily than other body areas, it is also more exposed, resulting in much higher demands on non-treatment times. Another important aspect of a facial procedure is that the face houses the most important human senses, whose function must not be impaired during treatment. Above all, the safety of the eyes must be ensured throughout the entire treatment.

[0008] The current aesthetic market offers either traditional, manually controlled radiofrequency or light devices that heat facial tissue to a target temperature in the range of 40°C–100°C, or unattended LED facial masks that operate using light effects (phototherapy) rather than heat. These masks are primarily intended for home use and do not pose a risk of burns, overheating, or overtreatment to patients. The varying facial shapes of individual patients are not a problem for these masks, as the energy delivered and the temperatures reached are so low that the risk of tissue damage due to heat is minimized and a homogeneous treatment is not required.Due to the low temperatures involved, it's also not important for such devices to maintain a predetermined distance between the individual diodes and the patient's skin, and the shape of the masks is only a fairly approximate representation of the human face. However, their application is severely limited by the low energy and minimal to nonexistent thermal effect, which is why they are considered more of a preventative tool for daily use than an in-office skin rejuvenation procedure with immediate results.

[0009] Today, there is a need in the aesthetic market for the combination of heat treatment using electromagnetic energy delivered to the epidermis, dermis, hypodermis, or adipose tissue, with secondary energy that provides muscle contraction or stimulation in the field of improving the patient's visual appearance. However, none of the actual devices are designed for the treatment of uneven, rough areas such as the face. In addition, the commercially available devices are typically handheld devices that require the operation of a medical professional throughout the treatment.

[0010] Therefore, it is necessary to improve medical devices that provide more than one treatment energy (e.g., electromagnetic energy and electrical current) so that both energies can be delivered via different active elements or the same active element (e.g., electrode). Furthermore, the device's applicator or pad must be attached to the patient, allowing unattended treatment, and the applicator or pad must be made of a flexible material that allows sufficient contact with the uneven treatment area of ​​the patient's body part. SUMMARY OF THE INVENTION

[0011] To enable well-defined, unattended treatment of a patient's uneven, rough areas (e.g., the face) while maintaining safety, methods and devices for minimally invasive to non-invasive delivery of electromagnetic energy via a single active element or a plurality of active elements have been proposed.

[0012] The patient may include skin and a body part, where a body part may refer to a body area.

[0013] The desired effect of improving the patient's visual appearance may, depending on the patient, involve heating a tissue (e.g., skin) in the range of 37.5°C to 55°C, tissue coagulation at temperatures of 50°C to 70°C, or tissue ablation at temperatures of 55°C to 130°C. Different patients and skin conditions may require different treatment approaches—higher temperatures allow for better results with fewer sessions but require a longer healing time, while lower temperatures allow for uninterrupted treatment but with limited results in more sessions. Another effect of heating may be to reduce the number of fat cells.

[0014] Another desired effect may be muscle contraction, which induces muscle stimulation (e.g., strengthening or toning) to improve the patient's visual appearance.

[0015] An arrangement for contact or contactless therapy was proposed.

[0016] For contact therapy, the proposed devices and methods comprise at least one electromagnetic energy generator in a main unit, which generates electromagnetic energy that is delivered to the treatment area via at least one active element attached to the skin. At least one active element can be embedded in a pad made of a flexible material that adapts to the shape of the rough surface. An underside of the pad can include an adhesive layer that allows the active elements to adhere to the treatment area and maintain the necessary tissue contact. Furthermore, the device can employ a safety system capable of adjusting one or more therapy parameters based on the values ​​measured by at least one sensor, e.g.Thermal sensors or impedance sensors capable of measuring the quality of contact with the treated tissue.

[0017] For contactless therapy, the proposed devices and methods comprise at least one electromagnetic energy generator in a main unit, which generates electromagnetic energy that is delivered to the treatment area via at least one active element located at a defined distance from the tissue to be treated. The distance of at least one active element from the treatment area can be monitored throughout the treatment, before, or after the treatment. Furthermore, the device can employ a safety system capable of adjusting one or more therapy parameters based on the values ​​measured by at least one sensor, e.g., one or more distance sensors.The energy can be delivered by a single static active element or a plurality of static active elements, or by the movement of a single active element or a plurality of active elements across the entire treatment area, for example, via a built-in automatic movement system, such as an integrated scanner. Treatment areas can be defined by laser vision—the operator can mark the area to be treated before treatment.

[0018] The active element can deliver energy across its entire surface or through a so-called fractional arrangement, where the active part contains a matrix formed by points of defined size. These points can be separated by inactive (and therefore untreated) areas, allowing for faster tissue healing. The surface area of ​​the points can range from 1% to 99% of the area of ​​the active element.

[0019] The electromagnetic energy can be primarily generated by a laser, a laser diode module, an LED, a flashlight, a filament lamp, or a radio frequency generator to cause heating of the patient. Additionally, acoustic, electrical, or electromagnetic energy that does not heat the patient can be delivered simultaneously, alternately, or overlapping with the primary electromagnetic energy.

[0020] Additionally, patient warming can be provided by a heated fluid, a magnetic field, ultrasound, or a heating element (e.g., a resistance wire or a Peltier cooler (thermoelectric cooler - TEC)).

[0021] The active element can emit more than one energy simultaneously (at the same time), successively, or overlappingly. For example, the active element can emit radio-frequency energy followed by electrical energy (electric current). In another example, the active element can emit the radio-frequency energy and the electrical energy at the same time.

[0022] Furthermore, the device may be configured to emit the electromagnetic field through at least one active element and simultaneously (at the same time) emit, for example, electrical energy through another element.

[0023] The proposed methods and devices may provide heating of tissue, contractions of muscles, or a combination of heating and muscle contractions.

[0024] In one aspect, the proposed device can provide three different types of energy. For example, radiofrequency energy, electric current, and magnetic field; radiofrequency energy, electric current, and pressure pulses; radiofrequency energy, magnetic field, and pressure pulses; or any other possible combination of energies provided by the proposed device.

[0025] Thus, the proposed methods and devices can temporarily lead to an improvement in a visual appearance, including, among other things, appropriate skin rejuvenation, wrinkle removal, skin tightening and lifting, cellulite and fat reduction, treatment of pigmented lesions, wrinkle smoothing, tattoo removal, soft tissue coagulation and ablation, reduction of vascular lesions, temporary relief of pain, muscle spasms, improvement of local blood circulation, etc., in uneven, rough areas, without causing further damage to vital parts of the patient's body, such as nerves or internal organs. The proposed method and devices can lead to a reduction in adipose tissue, e.g., through lipolysis or apoptosis of fat cells.

[0026] Furthermore, the proposed methods and devices may lead to an improvement in visual appearance, e.g., tissue rejuvenation via muscle strengthening or muscle tightening through muscle contractions induced by electrical current or electromagnetic energy and through elastogenesis and / or neocollagenesis, and / or to the relief of pain and / or muscle spasms and / or to the improvement of local blood circulation through heating with radiofrequency energy.

[0027] Alternatively, the proposed devices and methods may be used for post-operative treatment, e.g., after liposuction, e.g., for the treatment and / or healing of wounds caused by the surgery. BRIEF DESCRIPTION OF THE DRAWINGS Fig. Figure 1 shows a block diagram of a contact therapy device. Fig. Figure 2 is an illustration of a contact therapy facility. Fig. Figure 3A shows the shapes and layout of the pads. Fig. Figure 3B shows the shapes and layout of the pads. Fig. Figure 3C shows a possible pad shape and layout for treating a forehead. Fig. 3D shows a possible pad shape and layout for treating a cheek. Fig. Figure 3E illustrates a possible pad shape and layout for treating a cheek. Fig. 3F shows a possible pad shape and layout for treating a forehead. Fig. Figure 4A shows side views of a pad designed for contact therapy. Fig. Figure 4B shows side views of a pad designed for contact therapy. Fig. Figure 4C shows side views of a pad designed for contact therapy. Fig. 4D shows side views of a pad designed for contact therapy. Fig. Figure 4E shows a cross-section of a possible pad structure. Fig. Figure 5A shows a top view of a variant of the pad. Fig. Figure 5B shows a detailed view of a possible arrangement of the slot in the substrate. Fig. 6 shows a variant of energy release by switching several active elements. Fig. Figure 7 shows a block diagram of a contactless therapy device. Fig. Figure 8 is an illustration of a contactless therapy facility. Fig. Figure 9A is an illustration of the framed grid electrode. Fig. Figure 9B is an illustration of another framed grid electrode. Fig. Figure 9C is an illustration of a framed grid electrode with thinning conductive lines. Fig. Figure 9D is an illustration of an unframed grid electrode. Fig. Figure 9E is an illustration of an electrode with openings. Fig. Figure 9F is a possible illustration of an electrode. Fig. 9G is another illustration of an electrode. Fig. 9H is another illustration of an electrode. Fig. Figure 9I illustrates a detail of a framed grid electrode. Fig. 10 is an illustration of a treatment of a forehead with a pad. Fig. Figure 11A illustrates a continuous mode of electromagnetic energy. Fig. Figure 11B illustrates a pulse mode of electromagnetic energy. Fig. Figure 11C illustrates a pulse mode of secondary energy. Fig. Figure 11 D illustrates possible energy modulations that form energy envelopes. DETAILED DESCRIPTION

[0028] The presented methods and devices can be used to stimulate and / or treat a tissue, including, but not limited to, the skin, epidermis, dermis, hypodermis, or muscles. The proposed device is designed for minimally to non-invasive treatment of one or more tissue areas to enable well-defined, unattended treatment of the uneven, rough areas (e.g., facial area) by delivering electromagnetic energy via a single active element or a plurality of active elements without causing further injury to important parts of the patient's body, e.g. nerves or internal organs.

[0029] In addition, the presented methods and devices can be used to stimulate body parts or areas such as the head, neck, bra fat, waist fat, torso, back, abdomen, buttocks, thighs, calves, legs, arms, forearms, hands, fingers or body cavities (e.g., vagina, anus, mouth, inner ear, etc.).

[0030] The proposed methods and devices may include multiple visual appearance enhancement protocols that may be pre-programmed in the control unit (e.g., CPU - central processing unit, which may include a flexible circuit or a printed circuit board and may include a microprocessor or a memory for controlling the device).

[0031] The desired effect may include heating of tissue (e.g. a skin surface) (heat therapy) in the range of 37.5°C to 55°C or in the range of 38°C to 53°C or in the range of 39°C to 52°C or in the range of 40°C to 50°C or in the range of 41°C to 45°C, tissue coagulation at temperatures in the range of 50°C to 70°C or in the range of 51°C to 65°C or in the range of 52°C to 62°C or in the range of 53°C to 60°C or tissue ablation at temperatures in the range of 55°C to 130°C or in the range of 58°C to 120°C or in the range of 60°C to 110°C or in the range of 60°C to 100°C. The device can be operated in contact or contactless mode.In contact therapy the target skin temperature can typically be in the range of 37.5°C to 95°C or in the range of 38°C to 90°C or in the range of 39°C to 85°C or in the range of 40°C to 80°C whereas in non-contact therapy the target skin temperature can be in the range of 37.5°C to 130°C or in the range of 38°C to 120°C or in the range of 39°C to 110°C or in the range of 40°C to 100°C. The temperature in the range of 37.5°C to 130°C or in the range of 38°C to 120°C or in the range of 39°C to 110°C or in the range of 40°C to 100°C can be used to stimulate fibroblasts and to form connective tissue - e.g. B. 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°C to 130°C, or in the range of 38°C to 120°C, or in the range of 39°C to 110°C, or in the range of 40°C to 100°C can also lead to changes in adipose tissue. During the high-temperature-induced process of apoptosis, fat cells break down into apoptotic bodies and are further removed by the process of phagocytosis. During a process called necrosis, high temperatures cause fat cells to rupture and their contents to be released into an extracellular matrix. Both processes can lead to a reduction in fat layers, thus enabling facial remodeling. Facial fat removal can be beneficial, for example, in areas such as the submentum or cheeks.

[0032] Another desired effect may include tissue rejuvenation, e.g., muscle strengthening through muscle contraction induced by electrical or electromagnetic energy that does not heat the patient, or muscle relaxation induced by pressure massage. The combined effect of muscle contractions induced by electrical energy and heating of tissue (e.g., the skin) by an electromagnetic field, as described, can lead to a significant improvement in visual appearance.

[0033] Fig. 1 and Fig. 2 are discussed together. Fig. 1 shows a block diagram of a contact therapy device 1. Fig. Figure 2 is an illustration of a contact therapy device 1. The contact therapy device 1 may comprise two main blocks: a main unit 2 and a pad 4. Additionally, the device 1 may comprise a connecting block 3 or a neutral electrode 7. However, the components of the connecting block 3 may be implemented in the main unit 2.

[0034] The main unit 2 may include one or more generators: a primary electromagnetic generator 6, which can preferably emit radio frequency energy in the range of 10 kHz to 300 GHz or 300 kHz to 10 GHz or 400 kHz to 6 GHz, or in the range of 100 kHz to 550 MHz or 250 kHz to 500 MHz or 350 kHz to 100 MHz or 400 kHz to 80 MHz, a secondary generator 9, which can additionally emit electromagnetic energy that does not heat the patient, or can emit an electric current, in the range of 1 Hz to 10 MHz or 5 Hz to 5 MHz or in the range of 10 Hz to 1 MHz or in the range of 20 Hz to 1 kHz or in the range of 40 Hz to 500 Hz or in the range of 50 Hz to 300 Hz, and / or an ultrasound emitter 10, which can additionally emit sound energy with a frequency in the range of 20 kHz to 25 GHz or 20 kHz to 1 GHz or 50 kHz to 250 MHz or 100 kHz to 100 MHz.Additionally, the frequency of the ultrasonic energy can be in the range of 20 kHz to 80 MHz or 50 kHz to 50 MHz or 150 kHz to 20 MHz.

[0035] The output power of the radio frequency energy may be less than or equal to 450 W, 300 W, 250 W, or 220 W. In addition, the radio frequency energy at the output of the primary electromagnetic generator 6 (e.g., radio frequency generator) may be in the range of 0.1 W to 400 W, or in the range of 0.5 W to 300 W, or in the range of 1 W to 200 W, or in the range of 10 W to 150 W. The radio frequency energy may be applied in the ISM bands of 6.78 MHz, 13.56 MHz, 27.12 MHz, 40.68 MHz, 433.92 MHz, 915 MHz, 2.45 GHz, and 5.8 GHz, or in the vicinity thereof.

[0036] The primary generator 6 can also provide more than one radio frequency energy with different parameters. As a non-limiting example, the primary generator can generate one radio frequency energy with a frequency in a range of 100 kHz to 550 MHz, 250 kHz to 500 MHz, 350 kHz to 100 MHz, or 400 kHz to 80 MHz, and a second radio frequency energy with a frequency in a range of 400 kHz to 300 GHz, 500 kHz to 30 GHz, 600 kHz to 10 GHz, or 650 kHz to 6 GHz.

[0037] Additionally, patient heating may be provided by a heated fluid. In one aspect, the fluid may be heated in the heat generator within the main unit 2 and coupled to the pad 4 by a fluid conduit, which may be in the form of a closed circuit. When the heated fluid is delivered toward the patient via the active element in the pad 4, for example, via a pump, fan, or other fluid delivery system, it releases its heat, and the fluid is then returned to the heat generator where it is reheated. The fluid may be in the form of a liquid (e.g., water or oil) or a gas (e.g., air, nitrogen, carbon dioxide, carbon oxide, or other suitable gases known in the art). The fluid may be heated to a temperature in a range of 37.5°C to 100°C, in a range of 38°C to 64°C, or in a range of 40°C to 57°C.In one aspect, the heated fluid may serve as supplemental heating energy for the electromagnetic heating energy, or vice versa.

[0038] In one aspect, heating may be provided by a heating element, for example, a resistance wire or a Peltier cooler (TEC), which may be connected to the primary electromagnetic generator 6 or the secondary generator 9. In this aspect, the active element may be the heating element. The temperature on the surface of the heating element may be in a range of 37.5°C to 68°C, in a range of 38°C to 62°C, or in a range of 39°C to 50°C.

[0039] The main unit 2 may further include a human-machine interface 8 represented by a display, buttons, a keyboard, a touchpad, a touch panel, or other controls that allow an operator to review and adjust therapy and other device parameters. For example, it is possible to independently adjust the power, treatment time, or other treatment parameters of each generator (the primary electromagnetic generator 6, the secondary generator 9, and the ultrasound emitter 10). The human-machine interface 8 may be connected to the control unit 11 (e.g., the CPU). The power supply 5 located in the main unit 2 may include a transformer, a disposable battery, a rechargeable battery, a power plug, or a standard power cord.The output power of the power supply 5 can be in the range of 10 W to 600 W or in the range of 50 W to 500 W or in the range of 80 W to 450 W.

[0040] In addition, the human-machine interface 8 can also display information about the type of therapy used, the remaining therapy time and the main therapy parameters.

[0041] The connection block 3 can serve as a communication channel between the main unit 2 and the pad 4. It can be represented by a simple device containing basic indicators 17 and therapy control mechanisms. The indicators 17 can be implemented as a display, LEDs, sound signals, vibrations, or other forms that can provide an adequate indication to an operator and / or the patient.

[0042] The indicators 17 can indicate the actual patient temperature, contact information, or other sensor measurements, as well as the status of a switching process between the active elements, the quality of contact with the treated tissue, actual treatment parameters, the ongoing treatment, etc. The indicators 17 can be configured to warn the operator in case of suspicious therapy behavior, e.g., temperature outside the permissible range, incorrect contact with the treated tissue, automatically adjusted parameters, etc. The connection block 3 can be used as an additional safety feature for heat-sensitive patients. It can include an emergency stop button 16, allowing the patient to immediately stop the therapy at any time during the treatment.The switching circuit 14 may be responsible for switching between the active elements or for regulating the energy output of the primary electromagnetic generator 6, the secondary generator 9, or the ultrasonic emitter 10. The rate of switching between the active elements 13 may depend on the amount of energy delivered, the pulse length, etc., and / or on the speed of the switching circuit 14 and the control unit 11 (e.g., CPU). The switching circuit 14 may include a relay switch, a transistor (bipolar, PNP, NPN, FET, JFET, MOSFET), a thyristor, a diode, an optical switch, an optoelectric switch, or an optomechanical switch, or any other suitable switch known in the art. The circuit in conjunction with the control unit 11 (e.g.,CPU) can control the switching between the primary electromagnetic energy generated by the primary electromagnetic generator 6 and the secondary energy generated by the secondary generator 9 to the at least one active element 13.

[0043] In addition, the connection block 3 may contain the primary electromagnetic generator 6, the secondary generator 9 or the ultrasonic emitter 10 or only one of them or any combination thereof.

[0044] In one non-limiting aspect, the main unit 2 may include the primary electromagnetic generator 6, the connection block 3 may include the secondary generator 9, and the ultrasonic emitter 10 may not be present at all.

[0045] The control unit 11 (e.g. CPU) controls the primary electromagnetic generator 6 so that the primary electromagnetic energy can be delivered to the at least one active element in a continuous mode (CM) or a pulsed mode, with a fluence in the range of 10 mJ / cm 2 up to 50 kJ / cm 2 or in the range of 100 mJ / cm 2 up to 10 kJ / cm 2 or in the range of 0.5 J / cm 2 up to 1 kJ / cm 2The electromagnetic energy can be primarily generated by a laser, a laser diode module, an LED, a flash lamp, a filament lamp, or by a radio frequency generator to cause heating of the patient. The CM mode can be operated for a time interval in the range of 0.05 s to 60 min, or in the range of 0.1 s to 45 min, or in the range of 0.2 s to 30 min. The pulse duration of the energy delivery operated in the pulse pattern 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 primary electromagnetic generator 6 in the pulse pattern can be operated by a control unit 11 (e.g., CPU) in a single-shot mode or in a repetitive mode. The frequency of the repeat mode can be in the range of 0.05 to 10,000 Hz or in the range of 0.1 to 5,000 Hz or in the range of 0.3 to 2,000 Hz or in the range of 0.5 to 1,000 Hz.Alternatively, the frequency of the repetition mode may be in the range of 0.1 kHz to 200 MHz, or in the range of 0.5 kHz to 150 MHz, or in the range of 0.8 kHz to 100 MHz, or in the range of 1 kHz to 80 MHz. The single-shot mode may mean that only a single electromagnetic pulse with specific parameters (e.g., intensity, duration, etc.) is generated for delivery to a single treatment area. The repetition mode may mean that electromagnetic pulses, which may have the specific parameters (e.g., intensity, duration, etc.), are generated at a repetition rate of the aforementioned frequency for delivery to a single treatment area. The control unit (e.g.,The control unit 11 (e.g., CPU) can provide treatment control, such as stabilizing treatment parameters, including treatment time, power, duty cycle, the period regulating switching between multiple active elements, the temperature of the device 1, and the temperature of the primary electromagnetic generator 6 and the secondary generator 9 or the ultrasonic emitter 10. The control unit 11 (e.g., CPU) can drive and provide information from the circuit 14. The control unit 11 (e.g., CPU) can also receive and provide information from sensors located on or in the pad 4 or elsewhere in the device. Device 1. The control unit (e.g., CPU) 11 may include a flexible circuit or a printed circuit board and may include a microprocessor or memory for controlling the device.

[0046] Fig. Figure 11A shows the emission of electromagnetic energy in continuous mode. The electromagnetic waves 1101 (e.g., sinusoidal high-frequency waves) are emitted continuously from the starting time t0 with the continuous electromagnetic envelope 1103 (e.g., high-frequency envelope). Fig. Figure 11B shows the delivery of electromagnetic energy in pulse mode. The electromagnetic waves 1101 (e.g., sinusoidal radio frequency waves) are delivered in electromagnetic pulses 1102 (e.g., radio frequency pulses). The electromagnetic pulses 1102 can generate at least one electromagnetic envelope 1105 (e.g., radio frequency envelope) that can be Fig. 11B is shown as a rectangular electromagnetic envelope 1105. The electromagnetic envelopes (1103, 1105) can have various shapes, e.g., circular, semicircular, sinusoidal, rectangular, triangular, trapezoidal, or polygonal.

[0047] The electromagnetic waves 1101 (e.g., radio-frequency waves) can be modulated in amplitude or frequency within an electromagnetic pulse (1102 or 1103) or can be modulated differently in different electromagnetic pulses. For example, a first electromagnetic pulse can have a rectangular envelope, and a second electromagnetic pulse following the first electromagnetic pulse can have a sinusoidal envelope. The pause time 1104 between two consecutive pulses 1102 can be in the range of 1 µs to 1 s, in the range of 500 µs to 500 ms, in the range of 1 ms to 450 ms, or in the range of 100 ms to 450 ms. The pause time 1104 is a time during which no electromagnetic waves are provided by the device.

[0048] The control unit 11 (e.g. CPU) can control the secondary generator 9 so that the secondary energy (e.g. electric current or magnetic field) can be delivered to the at least one active element in a continuous mode (CM) or a pulsed mode, with a fluence in the range of 10 mJ / cm 2 up to 50 kJ / cm 2 or in the range of 100 mJ / cm 2 up to 10 kJ / cm 2 or in the range of 0.5 J / cm 2 up to 1 kJ / cm 2on the surface of the at least one active element. The application of the secondary energy to the treatment area of ​​the patient can induce muscle contractions in the patient. The CM mode can be operated for a time interval in the range of 0.05 s to 60 min or in the range of 0.1 s to 45 min or in the range of 0.2 s to 30 min. The pulse duration of the delivery of the secondary energy in pulse pattern mode can be in the range of 0.1 µs to 10 s or in the range of 0.2 µs to 1 s or in the range of 0.5 µs to 500 ms or in the range of 0.5 to 10 s or in the range of 1 to 8 s or in the range of 1.5 to 5 s or in the range of 2 to 3 s. The secondary generator 9 in the pulse pattern can be operated by a control unit 11 (e.g., CPU) in a single-shot mode or in a repetitive mode. The frequency of the repetitive mode can be in the range of 0.1 to 12,000 Hz, or in the range of 0.1 to 8,000 Hz, or in the range of 0.1 to 5.000 Hz or in the range of 0.5 to 1,000 Hz.

[0049] Fig. Figure 11C shows the delivery of secondary energy in pulse mode. The secondary energy is delivered in the form of pulses 1111 of secondary energy (e.g., biphasic rectangular pulses of electric current), which are continuously provided from the start time t0 to the end time t1 and generate an envelope 1112 of secondary energy (e.g., an envelope of electric current). A possible pulse 1111 of secondary energy (e.g., an electric pulse) is shown in the dashed oval in Fig. 11C. The pulses 1111 of secondary energy may be delivered evenly one after the other or with a pause time 1113 of the pulses of secondary energy between the pulses 1111 of secondary energy, as in Fig. 11C. The pause time 1113 of the secondary energy pulses refers to a time during which no secondary energy is emitted / generated between two consecutive secondary energy pulses 1111. The duty cycle of the secondary energy pulse 1111 and the pause time 1113 of the secondary energy pulses can be in the range of 0.1% to 99%, the range of 0.5% to 50%, the range of 0.7% to 33%, the range of 1% to 17%, or the range of 1.5% to 10%. In one aspect, the pause time 1113 of the pulses of secondary energy may be in the range of 80 µs to 100 ms, or in the range of 160 µs to 50 ms, or in the range of 250 µs to 10 ms, or in the range of 0.5 ms to 7 ms.

[0050] The secondary energy (e.g. pulses of electrical or magnetic field pulses) generated by the secondary generator 9 can be modulated in frequency or amplitude in the same way as the electromagnetic energy (e.g. radio frequency waves) generated by the primary generator 6, thereby generating different shapes of envelopes of secondary energy (e.g. envelopes of electric current) as shown in Fig. 11D. A first triangular envelope 1112a comprises, for example, a series of pulses 1111 of secondary energy that are modulated in amplitude such that each successive pulse of secondary energy has a higher amplitude than the previous one. A second rectangular envelope 1112b comprises a series of pulses 1111 of secondary energy with the same amplitude. As shown in Fig. As can be seen in Figure 11D, the consecutive envelopes 1112a and 1112b may be separated by an envelope pause time, i.e., a time during which no pulses of secondary energy are generated / delivered and no envelope is formed. In one aspect, the envelope pause time 1114 is longer than the pulse pause time 1113. In another aspect, the envelope pause time 1114 has at least the length of the pulse 1111 of secondary energy plus the pause time 1113 of the pulses of secondary energy. In one aspect, the secondary energy may be modulated within an envelope 1112 of secondary energy, and the envelopes may be the same for the entire treatment, e.g., only one trapezoidal envelope may be delivered during the treatment. In another aspect, the secondary energy may be modulated differently for different envelopes 1112 of secondary energy delivered during the treatment, e.g.First, an increasing envelope may be delivered, then second, the rectangular envelope may be delivered, and then the decreasing triangular envelope may be delivered, with the envelopes separated by the envelope pause time 1114. The envelopes 1112 of secondary energy may be sinusoidal, triangular, conical, rectangular, trapezoidal, or polygonal.

[0051] The secondary energy (e.g., electric current or magnetic field) can also be frequency modulated within the secondary energy envelope 1112, which can cause an increasing or decreasing treatment response in the patient's body. For example, the electric current or magnetic field can be modulated so that the frequency of the secondary energy pulses 1111 increases, which can cause an increase in the intensity of muscle contractions. Then, the frequency of the secondary energy pulses 1111 can be constant, causing the same intensity of muscle contractions, and then the frequency of the secondary energy pulses 1111 can decrease, causing a decreasing intensity of muscle contractions.The same principle can be used for the primary electromagnetic energy, producing, for example, series of increasing, constant, and decreasing amplitudes of the electromagnetic energy or series of increasing, constant, and decreasing frequencies of the electromagnetic waves, both of which can cause increasing, constant, and decreasing heating of the patient's tissue.

[0052] Alternatively, it is also possible to use only one generator to generate one type of energy / signal and one or more converters to convert the energy / signal into one or more other types of energy / signal. For example, the primary generator can generate a high-frequency signal, which is converted into electrical current by the converter (e.g., through an electrical conversion circuit).

[0053] The proposed device may be a multi-channel device that allows the control unit (e.g. CPU) 11 to control the treatment of more than one treated area simultaneously.

[0054] Alternatively, the connection block 3 may not be part of the device 1, and the control unit (e.g., CPU) 11, the circuit 14, the indicators 17, and the emergency stop button 16 may be part of the main unit 2 or the pad 4. In addition, some of the control unit (e.g., CPU) 11, the circuit 14, the indicators 17, and the emergency stop button 16 may be part of the main unit 2, and some may be part of the pad 4. For example, the control unit (e.g., CPU) 11, the circuit 14, and the emergency stop button 16 may be part of the main unit 2, and the indicators 17 may be part of the pad 4.

[0055] The pad 4 represents the part of the device that may come into contact with the patient's skin during therapy. The pads 4 may be made of a flexible substrate material—for example, a polymer-based material, polyimide (PI) films, polytetrafluoroethylene (PTFE, e.g., Teflon®), epoxy, polyethylene terephthalate (PET), polyamide, or polyethylene (PE) foam—with an additional adhesive layer on the underside, e.g., a hypoallergenic adhesive gel (hydrogel) or adhesive tape, which may be bacteriostatic, non-irritating, or water-soluble. The substrate may also be a silicone-based substrate. The substrate may also be made of a fabric, e.g., a nonwoven fabric.The adhesive layer may have an impedance to a current at a frequency of 500 kHz in the range of 1 to 150 Ω, or in the range of 5 to 130 Ω, or in the range of 10 to 100 Ω, and the impedance to a current at a frequency of 100 Hz or less is three times or more of the impedance to a current at a frequency of 500 kHz. The adhesive hydrogel may be made of a polymer matrix or a mixture containing water, a polyhydric alcohol, a polyvinylpyrrolidone, a polyisocyanate component, or a polyol component, or having a methylenediphenyl structure in the main chain. In addition, a conductive adhesive (e.g., hydrogel) may be enriched with metallic fillers such as silver, gold, copper, aluminum, platinum, or titanium, or graphite, which may constitute 1 to 90%, 2 to 80%, or 5 to 70% of the adhesive.The adhesive layer can be covered with the conductive adhesive gel “STgele” or “Tensive®”, which is applied to the body to reduce its impedance and facilitate the delivery of an electric shock.

[0056] The adhesive layer, e.g., the hydrogel, can cover exactly the entire surface of the pad facing the patient's body area. The thickness of the hydrogel layer can range from 0.1 to 3 mm, from 0.3 to 2 mm, from 0.4 to 1.8 mm, or from 0.5 to 1.5 mm.

[0057] The adhesive layer under pad 4 can mean that the adhesive layer is located between the patient-facing surface of the pad and the patient's body. The adhesive layer can have an impedance 1.1 times, 2 times, 4 times, or up to 10 times higher than the impedance of the patient's skin under pad 4. One definition of skin impedance can be that it is a portion of the total impedance measured between two equipotential surfaces in contact with the epidermis and is inversely proportional to the electrode area when the internal current flow path is held constant. Data applicable to this definition are conveniently recorded 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 as for measuring skin impedance.The impedance of the adhesive layer can be higher than the impedance of the skin by a factor in the range of 1.1 to 20 times, or 1.2 to 15 times, or 1.3 to 10 times.

[0058] The impedance of the adhesive layer can vary depending on the different types of energy delivered to the patient. For example, the impedance may be different for radiofrequency and electrical current delivery. The impedance of the hydrogel can range from 100 to 2000 ohms for electrical current delivery (e.g., during electrotherapy), or from 150 to 1800 ohms, 200 to 1500 ohms, or 300 to 1200 ohms. In one aspect, the impedance of an adhesive layer (e.g., hydrogel) for alternating current at 1 kHz may be in the range of 100 to 5000 ohms, or 200 to 4500 ohms, or 500 to 4000 ohms, or 1000 to 3000 ohms, or 1200 to 2800 ohms, or 1500 to 2500 ohms. In another aspect, the impedance of the adhesive layer (e.g., hydrogel) for alternating current at 10 Hz may be in the range of 2000 to 4000 ohms, or 2300 to 3700 ohms, or 2500 to 3500 ohms.

[0059] The electrical conductivity of the adhesive layer at a high frequency of 3.2 MHz can be in the range of 20 to 200 mS / m or in the range of 50 to 140 mS / m or in the range of 60 to 120 mS / m or in the range of 70 to 100 mS / m.

[0060] Alternatively, the adhesive layer may be a composition of multiple elements, where some elements may have suitable physical properties (referred to herein as adhesive elements), e.g., suitable adhesive and / or conductivity and / or impedance and / or cooling properties, etc.; and some elements may have nutritional properties (referred to herein as nutritional elements), e.g., they may contain nutrients and / or vitamins and / or minerals and / or organic and / or inorganic substances with a nutritional effect that can be delivered to the patient's skin during treatment. The volumetric ratio of adhesive elements to nutritional elements may range from 1:1 to 20:1, or from 2:1 to 10:1, or from 3:1 to 5:1, or from 5:1 to 50:1, or from 10:1 to 40:1, or from 15:1. In one aspect, the adhesive layer composition may contain a hydrogel as the adhesive element and a hyaluronic acid as the nutritional element.In another aspect, the adhesive layer composition may contain a hydrogel as an adhesive element and one or more vitamins as nutritional elements. In another aspect, the adhesive layer composition may contain a hydrogel as an adhesive element and one or more minerals as nutritional elements.

[0061] In addition, the devices and methods may also comprise a skin bleaching ingredient, e.g., a skin lightening ingredient. The skin lightening ingredient may contain at least one of the following: 4-Methoxyphenol, Kojic Acid, Arbutin, Hydroquinone, Niacinamide, Ellagic Acid, 4-n-Butylresorcinol (Rucinol), Potassium 4-Methoxysalicylate (4MSK), Linoleic Acid, Tranexamic Acid, 4-(4-Hydroxyphenyl)-2-Butanol (Rododenol), Tranexamic Acid Cetyl Ester, Adenosine Monophosphate, Dexpanthenol, Magnesium L-Ascorbyl 2-Phosphate, Vitamin C, 3-O-Ethyl Ascorbic Acid, 5-Dipropylbiphenyl-2,2-diol, Ascorbyl Tetra-2-Hexyl Decanoate, Glutathione, Salicylic Acid, Glycolic Acid, Corticosteroids, Tretinonin, Alpha Hydroxyl Acids, Azelaic Acid, Glucosamine, Retinaldehyde, Retinol, Mequinol, Resvetrasol, Oxyresvaretral, Vitamin E, Thioctic Acid, Lactic Acid, Glycolic Acid, Liquiritin, Glycyrrhetinic Acid, Aloesin, Tocopheryl Acetate and / or Glabren.Furthermore, the skin-lightening ingredient may comprise any salt and / or modification of the above-mentioned compounds. In one aspect, the skin-lightening ingredients may be part of the adhesive layer. For example, the adhesive layer may comprise an adhesive portion (e.g., hydrogel) and / or nourishing elements (e.g., hyaluronic acid) and / or skin-lightening ingredients (e.g., skin-lightening ingredients).

[0062] In one aspect, the nourishing element can release itself continuously during the treatment. In another aspect, the nourishing element can be released due to the delivery of treatment energy (e.g., heat, radio frequency, light, electric current, magnetic field, or ultrasound) passing through the nourishing element, thus causing its release to the patient's skin.

[0063] In one aspect, the skin-bleaching ingredients (e.g., skin-lightening ingredients) can be released continuously during treatment. In another aspect, the skin-bleaching ingredients (e.g., the skin-lightening ingredient) can be released by the delivery of treatment energy (e.g., heat, radio frequency, light, electric current, magnetic field, or ultrasound) that can pass through the skin-bleaching ingredients (e.g., the skin-lightening ingredient), thus causing their release to the patient's skin.

[0064] In another aspect, the nourishing elements (e.g., hyaluronic acid) and / or the skin-whitening ingredients (e.g., skin-lightening ingredients) may not be part of the adhesive layer and may be bonded to the patient prior to applying the pad and / or the active element (e.g., the electrode). For example, the treatment area may be coated with the nourishing elements (e.g., hyaluronic acid) and / or the skin-lightening ingredients (e.g., skin-lightening agent), and then the pad may be applied to the treatment area (e.g., via the adhesive layer or tape, or in the form of a mask).

[0065] Another aspect is that the device and method can be used for iontophoresis (transdermal drug delivery). Drug molecules can be transported through the stratum corneum by electrophoresis and electroosmosis, and the electric field generated by the electric current can also increase skin permeability. The device can be used for therapeutic purposes by transporting a charged substance, typically a drug or bioactive agent, transdermally through the skin through a repulsive electromotive force, or for diagnostic purposes.

[0066] The pad containing the adhesive layer may be configured for single use (disposable).

[0067] Alternatively, the pad may not contain the adhesive layer and may comprise at least the substrate and the active element (e.g., the electrode).

[0068] In one aspect, at the start of treatment, the adhesive layer (e.g., the hydrogel) can be applied externally to the patient's surface prior to applying the pad. The pad is then coupled to the adhesive layer. In another aspect, a cover layer (e.g., a thin film) can be inserted between the adhesive layer and the pad. The film can be adhesive on one or both sides and provide for coupling the pad to the patient's body. In this case, it may be possible to use the same pad multiple times, as the cover layer ensures the hygienic safety of the pad.

[0069] Another aspect is that the adhesive layer (e.g. conductive adhesive hydrogel) does not have to be part of the pad and can be applied to the pad from the outside before the pad is bonded to the surface of the treatment area.

[0070] In another aspect, layers of another substance can be applied to the patient's surface before the pad is applied, and the pad is coupled to this layer. This can be a drug layer, a cooling layer (e.g., a cooling gel), a partial adhesive layer, or any other non-adhesive layer. In one aspect, the drug layer can comprise, for example, hyaluronic acid, one or more vitamins, one or more minerals, one or more skin-whitening ingredients, or any combination thereof. The active ingredient from the drug layer can be in the form of a solution (e.g., gel or cream) that is applied to the patient, or can be coupled to the cover layer (e.g., thin film), which is then applied to the patient's skin. The active ingredient can be delivered to the patient throughout the treatment by at least one energy provided by the pad (e.g.,Radiofrequency energy, heat, electric current, magnetic field, etc.) can be continuously released into the skin. In another aspect, the active ingredient can be released into the skin at the beginning, at some point during, or at the end of the treatment to visually improve the skin.

[0071] The pad 4 can also have a sticker on a top side of the pad. The top side is the side opposite the bottom side (the side on which the adhesive layer can be arranged) or, in other words, the top side is the side of the pad facing away from the patient during treatment. The sticker can have a bottom side and a top side, where the bottom side of the sticker can comprise an adhesive layer and the top side of the sticker can comprise a non-adhesive layer (e.g., polyimide (PI) films, PTFE (e.g., Teflon®), epoxy, polyethylene terephthalate (PET), polyamide or PE foam, PE film, or PVC foam). Thus, the sticker can be made of two layers (the top layer is non-adhesive and the bottom layer is adhesive). The sticker covers the top side of the pad and can also cover some sensors located on the top side of the pad (e.g., thermal sensors).

[0072] The sticker may have the same shape as the pad 4 or may additionally overlap the pad, e.g., extend beyond the shape of the pad 4. The sticker may be adhered to the pad with the adhesive layer on the underside of the sticker facing the top side of the pad 4. The top side of the sticker facing away from the pad 4 may be made of a non-adhesive layer. The linear dimension of the sticker with additional overlap may exceed the corresponding dimension of the pad in the range of 0.1 to 10 cm, or in the range of 0.1 to 7 cm, or in the range of 0.2 to 5 cm, or in the range of 0.2 to 3 cm, or in the range of 0.3 to 1 cm. The area of ​​the sticker (including the overlap) can be 0.5% to 50%, 1% to 40%, 1.5% to 33%, 2% to 25%, 3% to 20% or 5% to 15% larger than the area of ​​the pad.This overlap may also include an adhesive layer and can be used to create additional and better contact between the pad and the patient. The thickness of the sticker can range from 0.05 to 3 mm, or from 0.1 to 2 mm, or from 0.5 to 1.5 mm. The top of the sticker may contain printed information for easy identification of the pad, such as the manufacturer's brand or the proposed treatment area.

[0073] In one aspect, the adhesive layer, e.g., the hydrogel, on the underside of the pad facing the patient's body area can cover the entire surface of the pad and even overlap the surface of the pad and at least partially cover the adhesive layer overlap. In another aspect, the underside of the adhesive layer and / or the sticker overlap (both parts facing the patient) can be covered by a protective film that can be removed immediately before treatment. The protective film protects the adhesive layer and / or the sticker overlap, ensuring proper adhesion to the patient's body area upon removal of the protective film.

[0074] Alternatively, the pad 4 may have at least one suction opening, e.g., small cavities or slits adjacent to the active elements, or the active element may be embedded in a cavity. The suction opening may be connected to a pump, which may be part of the main unit 2, via a connecting tube. When the suction opening is brought into contact with the skin, the air sucked in by the suction opening flows toward the connecting tube and the pump, and the skin can be easily sucked into the suction opening. Thus, by applying a vacuum, the adhesion of the pad 4 can be provided. Furthermore, the pad 4 may comprise the adhesive layer and the suction openings for combined, stronger adhesion.

[0075] In addition to vacuum (negative pressure), the pump can also provide positive pressure by pumping the fluid to the intake port. Positive pressure is a pressure higher than atmospheric pressure, while negative pressure or vacuum is lower than atmospheric pressure. Atmospheric pressure is the pressure of the air in the room during therapy.

[0076] Pressure (positive or negative pressure) can be applied in pulses to the treatment area to provide a massage treatment. The massage treatment can be delivered through one or more suction ports, which vary the pressure applied to the patient's soft tissue, with the suction ports applying different pressures to the patient's tissue. Furthermore, the suction ports can create a pressure gradient in the soft tissue without touching the skin.

[0077] Such pressure gradients can be directed to the soft tissue layer, subcutaneously, and / or to another soft tissue structure.

[0078] Massage accelerates and enhances treatment therapy through electromagnetic energy, electrical energy or electromagnetic energy that does not heat the patient, improves blood and / or lymph circulation, angioedema, erythema effect, accelerates fat removal, accelerates metabolism, accelerates elastogenesis and / or neocollagenesis.

[0079] Each intake port may provide pressure through a suction mechanism, a flow of air or gas, a flow of liquid, pressure provided by an object contained within the intake port (e.g., a massage object, pressure cells, etc.), and / or by other means.

[0080] The pressure value applied to the patient's tissue means that a suction opening providing a massage effect applies positive pressure, negative pressure and / or sequentially alternating positive and negative pressure to the treated and / or adjacent tissue structures of the patient and / or creates a pressure gradient below the patient's tissue surface.

[0081] Massage applied to improve body fluid flow (e.g., lymphatic drainage) and / or relax tissue in the superficial soft tissue layers may be applied at a pressure lower than that used during massage of deeper soft tissue layers. Such positive or negative pressure compared to atmospheric pressure can be within a range of 10 Pa to 30,000 Pa, or within a range of 100 Pa to 20,000 Pa, or within a range of 0.5 kPa to 19 kPa, or within a range of 1 kPa to 15 kPa.

[0082] A massage applied to improve body fluid flow and / or tissue relaxation in the deeper soft tissue layers can be applied at higher pressures. Such positive or negative pressure can range from 12 kPa to 400 kPa, 15 kPa to 300 kPa, or 20 kPa to 200 kPa. The unpleasant sensation of excessive pressure applied can be used to establish a pressure threshold based on individual patient feedback.

[0083] Negative pressure can stimulate body fluid flow and / or relaxation of deep soft tissue layers (0.5 cm to an unrestricted depth within the soft tissue) and / or soft tissue layers near the patient's surface (0.1 mm to 0.5 cm). To increase the effectiveness of the massage, a negative pressure treatment can be followed by a positive pressure treatment.

[0084] The number of suction openings that change the pressure values ​​on the patient's soft tissue in a pad 4 can be between 1 and 100 or between 1 and 80 or between 1 and 40 or between 1 and 10.

[0085] The sizes and / or shapes of the suction holes may vary depending on the treated area. One suction hole can cover an area on the patient surface between 0.1 mm 2 up to 1 cm 2 or between 0.1 mm 2 up to 50 mm 2 or between 0.1 mm 2 up to 40 mm 2 or between 0.1 mm 2 up to 20 mm 2 Another suction port can cover an area on the patient surface between 1 cm 2 up to 1 m 2 or between 1 cm 2 up to 100 cm 2 or between 1 cm 2 up to 50 cm 2 or between 1 cm 2 up to 40 cm 2 cover.

[0086] Multiple intake ports can operate simultaneously or they can be switched between at intervals of 1 ms to 10 s or at intervals of 10 ms to 5 s or at intervals of 0.5 s to 2 s.

[0087] The suction ports for providing the massage effect can be controlled according to one or more predetermined massage profiles included in the one or more treatment protocols. The massage profile can be selected by the operator and / or a control unit (e.g., CPU) depending on the patient's condition. For example, a patient with lymphedema may require a different compression profile level and applied pressure than a patient with a healed leg ulcer.

[0088] The pressure applied through one or more suction ports can be applied gradually and preferably in the positive direction of lymphatic flow and / or blood flow in the veins. Depending on the specific treatment protocols, the pressure can be gradually applied in a direction opposite to or different from normal lymphatic flow. The pressure applied during treatment can vary depending on the treatment protocol.

[0089] A pressure gradient may develop between the individual suction ports. The examples of the described gradients are not limited to this method and / or procedure. The pressure gradient setting between at least two previous and successive suction ports can be as follows: 0%, meaning the pressure applied through the suction ports is equal (e.g., the pressure in all suction ports of the pad is equal);

[0090] 1%, i.e. the applied pressure between a previous and a successive intake port decreases and / or increases with a gradient of 1% (e.g. the pressure in the first intake port is 5 kPa and the pressure in the successive intake port is 4.95 kPa);

[0091] 2%, meaning the pressure increases or decreases with a gradient of 2%. The pressure gradient between two suction ports can range from 0% to 100%, where 100% means that one of the suction ports is inactive and / or is not applying pressure to the patient's soft tissue.

[0092] A treatment protocol controlling the application of the pressure gradient between a previous and a successive aspiration opening may range from 0.1% to 95%, or from 0.1% to 70%, or from 1% to 50%.

[0093] The suction port may further comprise an impacting massage object driven by a piston, a massage object driven by filling or sucking fluid or air from the gap volume through an inlet / outlet valve, or a massage object driven by an element generating an electric field, a magnetic field, or an electromagnetic field. Additionally, the massage may be provided by the impact of multiple massage objects. The multiple massage objects may be the same or different sizes, shapes, or weights, or may be made of the same or different materials. The massage objects may be accelerated by air or fluid flow (through the valve) or by an electric, magnetic, or electromagnetic field.The movement path of the massage objects can be random, circular, linear and / or the massage objects can rotate around one or more axes and / or can perform other types of movements in the gap volume.

[0094] The massage unit can also include a membrane on the side facing the patient, which can be accelerated by an electric, magnetic, or 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.

[0095] During treatment, it may be advantageous to use a combination of pads with an adhesive layer and pads with suction openings. In this case, at least one pad used during treatment may include an adhesive layer, and at least one additional pad used during treatment may include a suction opening. For example, the pad with the adhesive layer may be suitable for treating uneven areas, such as the periorbital area, and the pad with suction openings may be suitable for treating smoother areas, such as the cheeks.

[0096] The advantage of the device, in which the attachment of the pads can be provided by an adhesive layer or by a suction opening or a combination thereof, is that there is no need for an additional gripping system necessary to hold the pads to the treatment area during treatment, e.g., a band or felt, which can be uncomfortable for the patient.

[0097] In one aspect, the intake ports may provide the heated fluid to effect patient heating (e.g., hot air), which may be provided in place of, or as a supplement to, the primary electromagnetic energy (e.g., radio frequency energy).

[0098] In yet another aspect, it is possible to attach the flexible pads 4 to the face by at least one fastening mechanism, for example a band or felt, which may be made of an elastic material and thus adaptable to an individual face. In this case, the flexible pads, which may not have an adhesive layer or a suction opening, are placed on the patient's treatment area and their position is then secured by a band or felt to prevent the pads from shifting from the treatment areas. Alternatively, the band can be replaced by a mask, e.g., an elastic mask that covers 5% to 100%, or 30% to 99%, or 40% to 95%, or 50% to 90% of the face and can serve to secure the flexible pads to the treatment areas. In another aspect, the mask can be rigid or semi-rigid.The mask may contain a connector with conductive wires, which then distributes the conductive wires to specific pads. Furthermore, it may be possible to use a combination of the pad with an adhesive layer or suction port and the fastening strap, felt, or mask to ensure a strong attachment of the pads to the treatment areas.

[0099] In one aspect, the pad can be replaced by the mask; for example, the mask can have the properties of the pad as described in the application. For example, one or more active elements (e.g., electrodes) can be arranged on the mask, which the substrate can comprise. In one aspect, the mask can be attached to the patient by any means possible for the pads, e.g., by the adhesive layer, the tape, or the felt, or by suction openings as described above. As a non-limiting example, the mask can have 2 to 100, or 3 to 50, or 4 to 20 active elements (e.g., electrodes) that can be connected to the patient's face by the adhesive layer, and / or the mask can be attached to the patient's head by the tape that encloses the mask and the head. The tape can, for example, be connected to the mask and placed behind and / or over the patient's head.

[0100] Additionally, the attachment mechanism may take the form of a fabric or garment mountable on a part of the patient's body. During use of the device, one surface of the active element or pad 4 rests against an inner surface of the garment, while the opposite surface of the active element or pad 4 is in contact with the patient's skin, preferably through an interface between the skin and the hydrogel of the active element.

[0101] The garment may be fastened to or around a part of the patient's body, e.g., by means of a hook-and-loop fastener, a button, a buckle, a rivet, a leash or cord, a magnetically guided closure system, or a clamp band, and the garment may be made of flexible materials or fabrics that conform to the shape of the patient's body or limb. The pad 4 may be configured in the same way to be attached to an inner surface of the garment. The garment is preferably made of breathable materials. Non-limiting examples of such materials include soft neoprene, nylon, polyurethane, polyester, polyamide, polypropylene, silicone, cotton, or any other material that is soft and flexible. All of the aforementioned materials could be used as woven fabrics, nonwoven fabrics, disposable fabrics, or laminated structures.

[0102] The garment and the pad may be a modular system, i.e. a module or element of the device (pad, garment) and / or the system is designed separately and independently from the other modules or elements, while at the same time being compatible with each other.

[0103] The pad 4 can be designed to be attached to or in contact with the garment so that it is supported by the garment in a stationary or fixed state, such that the pads are arranged at fixed positions on the garment. The garment ensures the correct adhesion or arrangement of the pad on the patient's skin. During use of the device, 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 the pad-skin interface. Therefore, the active elements contained in the pad are in contact with the patient's skin.

[0104] The optimal placement of the pad on the patient's body part and thus of the garment that supports the pad with the active elements is determined by a technician or doctor assisting the patient.

[0105] Additionally, the garment may encompass more than one pad, or the patient may wear more than one garment encompassing more than one pad during a treatment session.

[0106] The pad 4 contains at least one active element 13 capable of delivering energy from the primary electromagnetic generator 6 or the secondary generator 9 or the ultrasonic emitter 10. In various aspects, the active element is an electrode, an optical element, a sonic window, an ultrasonic emitter, a coil, a fluid conduit, a heating element, or other energy delivery elements 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 (e.g., dielectric) material. The RF electrode may be monopolar, bipolar, unipolar, or multipolar. The bipolar arrangement may consist of electrodes that alternate between active and return functions and where the thermal gradient among the electrodes is nearly equal during treatment.Bipolar electrodes can be circular or elliptical, with the electrodes concentric to each other. However, an array of bipolar electrode systems can also be used. A unipolar electrode or one or more multipolar electrodes can also be used. Alternatively, the system can use monopolar electrodes, with the so-called return electrode (or neutral electrode or ground electrode or earth electrode) having a larger surface area than the so-called active electrode. The thermal gradient under the active electrode is therefore higher than under the return electrode. The active electrode can be part of the pad, and the passive electrode with a larger surface area can be located at least 5 cm, 10 cm, or 20 cm from the pad. A neutral electrode can be used as the passive electrode.The return electrode can be located on the opposite side of the patient's body to where the pad is attached. Optionally, a unipolar electrode can also be used. During unipolar energy delivery, there is one electrode, no return electrode, and a large RF field emitted in an omnidirectional field around a single electrode. Capacitive and / or resistive electrodes can be used. Radiofrequency energy can produce an energy flux on the surface of the RF electrode or on the surface of the treated tissue (e.g., skin) in the range of 0.001 W / cm. 2 up to 1500 W / cm 2 or 0.01 W / cm 2 up to 1000 W / cm 2 or 0.5 W / cm 2 up to 500 W / cm 2 or 0.5 W / cm 2 up to 100 W / cm 2 or 1 W / cm 2 up to 50 W / cm 2The energy flux on the surface of the RF electrode can be calculated from the size of the RF electrode and its energy output. The energy flux on the surface of the treated tissue can be calculated from the size of the treated tissue directly beneath the RF electrode and the energy input provided by the RF electrode. Furthermore, the RF electrode positioned in pad 4 can serve as an acoustic window for ultrasonic energy.

[0107] The active element 13 can provide secondary energy from the secondary generator 9 in the form of an electric current or a magnetic field. By applying the secondary energy to the treated area of ​​the patient's body, stimulation of the muscle fibers (e.g., muscle contractions) can be achieved, thereby increasing muscle tone, strengthening muscles, restoring muscle sensation, relaxing muscles, and / or stretching muscles.

[0108] The magnetic field provided by the active element 13 (e.g. coil) used to simulate the muscle may be in the range of 0.01 T to 7 T or in the range of 0.015 T to 4 T or in the range of 0.02 T to 1 T or in the range of 0.05 T to 0.5 T on the surface of the active element (e.g. coil). The maximum value of the derivative of the magnetic flux density can be in the range from 1 T / s to 800 kT / s or in the range from 40 T / s to 320 kT / s or in the range from 80 T / s to 250 kT / s or in the range from 100 T / s to 250 kT / s or in the range from 250 T / s to 180 kT / s or in the range from 500 T / s to 100 kT / s or in the range from 1 kT / s to 65 kT / s. The value of the derivative of the magnetic flux density can correspond to the induced current in the tissue. The pulse duration of the magnetic field can be in the range from 3 µs to 10 ms or alternatively 3 µs to 3 ms or alternatively 3 µs to 1 ms. The active element 13 (e.g.Coil) can provide magnetic field pulses with the frequency in the range of 1 Hz to 1200 kHz or in the range of 2 Hz to 600 Hz or in the range of 3 Hz to 250 Hz or in the range of 4 Hz to 150 Hz or in the range of 4 Hz to 65 Hz.

[0109] An inductance of the active element 13 (e.g., coil) used to generate the magnetic field may be in the range of 1 nH to 500 mH, or in the range of 10 nH to 50 mH, or in the range of 50 nH to 10 mH, or in the range of 500 nH to 1 mH, or in the range of 1 µH to 500 µH. Alternatively, the inductance of the active element (e.g., coil) used to generate the magnetic field may be in the range of 1 nH to 100 µH, or in the range of 5 nH to 50 µH, or in the range of 10 nH to 25 µH, or in the range of 45 nH to 20 µH.

[0110] The proposed device can perform electrotherapy if the secondary energy delivered by the active element 13 (e.g., an electrotherapy electrode or simply referred to as an electrode, which may also be the radiofrequency electrode as described above) is the electric current generated by the secondary generator 9. The main effects of electrotherapy are: pain relief, myorelaxation, iontophoresis, anti-edematous effect, or muscle stimulation, which causes contraction of muscle fibers.

[0111] Each of these effects can be achieved through one or more types of electrotherapy: galvanic current, pulsed direct current, and alternating current.

[0112] Galvanic current (or "continuous current") is a current that can have a constant electrical current and / or whose absolute value is greater than 0 at any given moment. It can be used primarily for iontophoresis, or its effect of trophic (hyperaemic) stimulation can be utilized. In the present invention, this current can often be replaced with intermittent galvanic current. Furthermore, the galvanic component can be approximately 95%, but by interrupting the original continuous intensity, the frequency can reach 5-12 kHz, 5-10 kHz, 5-9 kHz, or 58 kHz.

[0113] Pulsed direct current (DC) is of variable intensity but has only one polarity. The basic pulse shape can vary. These include, for example, diadynamic, rectangular, triangular, and exponential pulses of one polarity. Depending on the frequency and intensity used, it can have stimulating, tropic, analgesic, myorelaxing, iontophoretic, at least partial muscle contracting, anti-edematous, and / or other effects.

[0114] Alternating current (AC or biphasic), where the basic pulse shape can vary—rectangular, triangular, harmonic, sinusoidal, exponential, and / or other shapes and / or combinations of the above. It can be alternating, symmetrical, and / or asymmetrical. The use of alternating currents in contact electrotherapy means a much lower stress on the tissue beneath the electrode. This type of current involves the capacitive component of skin resistance, which is why these currents are very well tolerated by patients.

[0115] AC therapies can be divided into five subtypes: TENS, classical (quadruple-polar) interference, bipolar interference, isoplanar interference, and dipole vector field. In addition, there are some specific electrotherapy energy variants and modularity in the period, form of energy, etc.

[0116] Through interferential electrotherapy, various nerves and tissue structures can be stimulated by medium frequency in a range of 500 Hz to 12 kHz or in a range of 500 Hz to 8 kHz or 500 Hz to 6 kHz, creating pulse envelopes with frequencies for stimulating nerves and tissues, e.g. sympathetic nerves (0.1-5 Hz), parasympathetic nerves (10-150 Hz), motor nerves (10-50 Hz), smooth muscles (0.1-10 Hz), sensory nerves (90-100 Hz), nociceptive fibers (90-150 Hz).

[0117] In electrotherapy, stimuli can be provided with currents with a frequency in the range of 0.1 Hz to 12 kHz or in the range of 0.1 Hz to 8 kHz or in the range of 0.1 Hz to 6 kHz.

[0118] Stimulation of muscle fibers through electrotherapy can be important during and / or as part of RF treatment. Muscle stimulation increases blood flow and lymph circulation. It can enhance the removal of treated cells and / or prevent the formation of hot spots. Furthermore, internal massage stimulation of the adjacent tissues improves tissue homogeneity and the distribution of the delivered energy. Stimulation of muscle fibers through electrotherapy can induce muscle contractions, which can lead to an improvement in the patient's visual appearance through muscle toning and strengthening. Another beneficial effect is during fat removal with RF therapy, for example. RF therapy can change the structure of fatty tissue. Stimulation of muscle fibers can provide an internal massage, which can be more effective than traditional massage in overweight patients.

[0119] Muscle stimulation can be provided, for example, by intermittent direct currents, alternating currents (e.g., medium frequency currents, Russian currents, and TENS currents), faradic current as a method of multiple stimulation, and / or others.

[0120] The frequency of the currents can be in the range from 0.1 Hz to 1500 Hz or from 0.1 to 1000 Hz or from 0.1 Hz to 500 Hz or from 0.1 to 300 Hz.

[0121] The frequency of the current envelope is typically in the range of 0.1 Hz to 500 Hz, or from 0.1 to 250 Hz, or from 0.1 Hz to 150 Hz, or from 0.1 to 140 Hz. In addition, the current envelopes can have an envelope repetition frequency (ERF) in the range of 0.01 to 100 per second, or from 0.05 to 50 per second, or from 0.07 to 30 per second, or from 0.1 to 20 per second, or from 0.2 to 6 per second.

[0122] Electrical stimulation can be delivered in a combined manner, allowing different treatments with different effects to be achieved. As an illustrative example, the electromagnetic energy with electrical stimulation can be dosed in pulse trains of electrical current, where the first electrical stimulation train can achieve a different effect than the second or another successive stimulation train. Therefore, the treatment can provide stimulation of muscle fibers or muscle contractions followed by relaxation during a continuous or pulsed high-frequency heat treatment delivered by electromagnetic energy provided by an electromagnetic energy generator.

[0123] Electrical stimulation can be provided through monopolar, unipolar, bipolar or multipolar mode.

[0124] The absolute value of the voltage between the electrotherapy electrodes operated in bipolar, multipolar mode (flow of electrical current between more than two electrodes) and / or provided to at least one electrotherapy electrode may be in a range between 0.8 V and 10 kV; or in a range between 1 V and 1 kV; or in a range between 1 V and 300 V; or in a range between 1 V and 100 V; or in a range between 10 V and 80 V; or in a range between 20 V and 60 V; or in a range between 30 V and 50 V.

[0125] The current density of electrotherapy can be adjusted with a non-galvanic current in a range between 0.1 mA / cm 2 and 150 mA / cm 2 or in a range between 0.1 mA / cm 2 and 100 mA / cm 2 or in a range between 0.1 mA / cm 2 and 50 mA / cm 2 or in a range between 0.1 mA / cm 2 and 20 mA / cm2 for a galvanic current, it can preferably be in a range between 0.05 mA / cm 2 and 3 mA / cm 2 or in a range between 0.1 mA / cm 2 and 1 mA / cm 2 or in a range between 0.01 mA / cm 2 and 0.5 mA / cm 2 The current density can be calculated at the surface of the electrode that provides electrotherapy to the patient. In one aspect, the current density of the

[0126] Electrotherapy for a non-galvanic current in a range between 0.1 mA / cm 2 and 200 mA / cm 2 , or in a range between 0.5 mA / cm 2 and 150 mA / cm 2 , or in a range between 1 mA / cm 2 and 120 mA / cm 2 , or in a range between 5 mA / cm 2 and 100 mA / cm 2 lay.

[0127] In the case of pulsed current (e.g., pulse mode), the electrical current in a pulse can be in the range of 0.5 mA to 150 mA, in the range of 1 mA to 100 mA, in the range of 5 mA to 75 mA, or in the range of 10 mA to 55 mA. The duration of an electrical current pulse can preferably be in the range of 1 to 500 µs, in the range of 10 to 350 µs, in the range of 20 to 200 µs, in the range of 35 to 150 µs, or in the range of 50 to 100 µs.

[0128] During electrotherapy, such as bipolar electrotherapy, two or more electrodes can be used. If the polarity of at least one electrode in an electrode group has a non-zero value during bipolar mode, the electrode group must include at least one electrode with an opposite polarity value. The absolute values ​​of the two electrode polarities can be equal or unequal. In bipolar electrical stimulation, the stimulation signal is passed through the tissue between electrodes with opposite polarities.

[0129] The distance between two electrodes operated in bipolar mode can be in a range between 0.1 mm and 4 cm or in a range between 0.2 mm and 3 cm or in a range between 0.5 mm and 2 cm or in a range between 1 mm and 1 cm or in a range between 2 mm and 7 mm or in a range between 0.1 cm and 40 cm or in a range between 1 cm and 30 cm or in a range between 1 cm and 20 cm, where the distance is the distance between the two nearest points of two electrodes operated in bipolar mode.

[0130] During monopolar electrotherapy, the stimulation signal can be induced by the excitation of an action potential by changing the polarity of an electrode, thereby changing the polarization in the nerve fiber and / or the neuromuscular layer.

[0131] During electrotherapy, one of the bipolar or monopolar electrotherapy modes can be used, or the bipolar or monopolar electrotherapy modes can be combined.

[0132] The ultrasound emitters can provide focused or defocused ultrasound energy. The ultrasound energy can be transmitted to the tissue through a sound window. The output power of the ultrasound energy on the surface of the active element 13 can be less than or equal to 20 W, 15 W, 10 W, or 5 W. The ultrasound energy can have an energy flux in the range of 0.001 W / cm on the surface of the active element 13 or on the surface of the treated tissue (e.g., skin). 2 up to 250 W / cm 2 or in the range of 0.005 W / cm 2 up to 50 W / cm 2 or in the range of 0.01 W / cm 2 up to 25 W / cm 2 or in the range of 0.05 W / cm 2 up to 20 W / cm 2The treatment depth of the ultrasonic energy can be in a range of 0.1 mm to 100 mm or 0.2 mm to 50 mm or 0.25 mm to 25 mm or 0.3 mm to 15 mm. At a depth of 5 mm, the ultrasonic energy can have an energy flux in the range of 0.01 W / cm 2 up to 20 W / cm 2 or 0.05 W / cm 2 up to 15 W / cm 2 An ultrasonic beam can have a beam inhomogeneity ratio (R BN) in the range of 0.1 to 20 or 2 to 15 to 4 to 10. Additionally, an ultrasound beam may have a beam inhomogeneity ratio of less than 15 or less than 10. An ultrasound beam may be divergent, convergent, and / or collimated. The ultrasound energy may be transmitted to the tissue through an acoustic window. It is possible that the electrode may serve as the acoustic window. Furthermore, the ultrasound emitter 10 may be part of the active element 13, thus the ultrasound emitter 10 may be part of the pad 4.

[0133] In one aspect, ultrasound may provide heating of the patient, and ultrasound emitter 10 may be used in place of the primary electromagnetic generator 6, which may not be present in the device. In another aspect, ultrasound may provide supplemental heating energy to the energy generated by the primary electromagnetic generator 6.

[0134] 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 ultrasound emitter 10 simultaneously (at the same time), successively, or in an overlapping manner, or in any combination thereof. For example, the active element 13 (e.g., electrode) may be capable of delivering radiofrequency energy and electrical current sequentially, which may mean that the active element 13 may first provide the primary electromagnetic energy generated by the primary electromagnetic generator 6, and the active element 13 may subsequently provide the secondary energy generated by the secondary generator 9. Thus, the active element 13 may, for example, apply radiofrequency energy to the patient's tissue, and then the same active element 13 may, for example, apply electrical current to the patient's tissue.In one case, the primary electromagnetic generator can generate both the radio frequency energy and the electric current.

[0135] In one aspect, the proposed device 1 may provide only one treatment energy, e.g., only electric current to cause muscle stimulation or only radiofrequency energy to cause tissue heating.

[0136] The active element (e.g., electrode or coil) can be cooled. A cooling element can provide cooling by any known mechanism, e.g., water cooling, sprayed coolant, the presence of an active solid cooling element (e.g., a Peltier cooler), or airflow cooling. Cooling of the active element (e.g., electrode or coil) can be provided during, before, or after the active element delivers energy to the patient. The temperature of the cooling element can range from -80°C to 36°C, from -70°C to 35°C, from -60°C to 34°C, from -20°C to 30°C, from 0°C to 27°C, or from 5°C to 25°C.

[0137] The pad 4 may further comprise thermal sensors 15 that enable temperature control during therapy, provide feedback to the control unit (e.g., CPU) 11, enable adjustment of the treatment parameters of each active element, and provide information to the operator. The thermal sensor 15 may be a contact sensor, a contactless sensor (e.g., an infrared temperature sensor), or an invasive sensor (e.g., a thermocouple) for precise temperature measurement in deep skin layers, e.g., in the

[0138] Epidermis, dermis, or hypodermis. The control unit (e.g., CPU) 11 can also use algorithms to calculate the lowest or highest temperatures. A temperature feedback system can control the temperature and warn the operator based on set or preset limits in a human-perceivable form, e.g., on the human-machine interface 8 or via the indicators 17. In a limit temperature condition, the device can be configured to adjust one or more treatment parameters, e.g., output power, switching mode, pulse length, etc., or to stop the treatment. A human-perceivable warning can be a sound, a warning message displayed on the human-machine interface 8 or the indicators 17, or a color change of any part of the connector block 3 or the pad 4.

[0139] The pad may include at least one electromyography (EMG) sensing electrode configured to monitor, record, or evaluate the electrical activity (e.g., twitches or contractions) generated by the skeletal muscles in response to the delivered energy (e.g., electrical current). The at least one EMG sensing electrode disposed on the pad may be electrically isolated from the active elements (e.g., the electrodes used for treatment). An electromyograph detects the electrical potential generated by muscle cells when those cells are electrically or neurologically activated. The signals may be analyzed to detect abnormalities, the activation level, or the recruitment order, or to analyze the biomechanics of the patient's movement. The EMG may be surface EMG or intramuscular EMG.Surface EMG can be recorded using a pair of electrodes or a more complex array of multiple electrodes. EMG recordings indicate the potential (voltage) difference between two separate electrodes. Alternatively, the active elements, such as electrodes, can be used for EMG. For example, if the active element is inactive (i.e., not providing / delivering any type of energy / signal to the patient), it can be used for EMG detection / recording. Intramuscular EMG can be recorded using one (monopolar) or multiple needle electrodes. These can be a fine wire inserted into a muscle, with a surface electrode as a reference, or several fine wires inserted into the muscle and related to each other. At rest, muscle tissue is normally electrically inactive.Action potentials appear following the electrical activity induced by the delivered energy (e.g., electric current). As the strength of a muscle contraction increases, more and more muscle fibers generate action potentials. When the muscle is fully contracted, a disordered group of action potentials with varying rates and amplitudes should appear (a complete recruitment and interference pattern).

[0140] The pad may also include at least one capacitive sensor for measuring correct contact of the pad with the patient. The capacitive sensor may be connected to at least two complementary metal-oxide-semiconductor (CMOS) integrated circuits (ICs), an application-specific integrated circuit (ASIC), and a digital signal processor (DSP), which may be part of the control unit. The capacitive sensor can detect and measure the skin based on its different dielectric properties compared to air, so that when the pad is released from the patient, a change in the signal can be detected and further processed by the control unit. The capacitive sensor can be configured with a surface capacitance configuration or a predicted capacitance configuration.For better contact information and to increase safety, a single pad can contain 3 to 30 or 4 to 20 or 5 to 18 or 6 to 16 or 7 to 14 capacitance sensors.

[0141] The memory 12 can, for example, contain information about the type and shape of the pad 4, its remaining usage time, or the time of therapy already performed with the pad. The memory can also provide information about the pad manufacturer or information about the intended area of ​​use on the patient's body. The memory can contain RFID, MRAM, resistors, or contacts.

[0142] The neutral electrode 7 can ensure the correct distribution of the radiofrequency energy in the patient's body in monopolar radiofrequency systems. The neutral electrode 7 is applied to the patient's skin before each therapy session so that the energy can be distributed between the active element 13 (e.g., electrode) and the neutral electrode 7. In some bipolar or multipolar radiofrequency systems, there is no need to use a neutral electrode, as the radiofrequency energy is distributed across multiple active elements 13 (e.g., electrodes). The neutral electrode 7 represents an optional block of the device 1, as any type of radiofrequency system can be integrated. In one aspect, the neutral electrode 7 can be part of the pad 4.

[0143] Additionally, the device 1 may include one or more sensors. The sensor may provide information about at least one physical quantity, and its measurement may result in feedback that may be displayed via the human-machine interface 8 or the indicators 17. The one or more sensors may be used to measure the emitted electromagnetic energy, the impedance of the skin, the resistance of the skin, the temperature of the treated skin, the temperature of the untreated skin, the temperature of at least one layer of the skin, the water content of the device, the phase angle of the emitted or reflected energy, the position of the active elements 13, the position of the connection block 3, the temperature of the cooling media, the temperature of the primary electromagnetic generator 6 and the secondary generator 9 and the ultrasonic emitter 10, or the contact with the skin.The sensor can be a thermal, acoustic, vibration, electrical, magnetic, flow, position, optical, imaging, pressure, force, energy flow, impedance, current, Hall, or proximity sensor. The sensor can be a capacitive displacement sensor, a sonic proximity sensor, a gyroscope, an accelerometer, a magnetometer, an infrared camera, or a thermal imaging camera. The sensor can be invasive or non-contact. The sensor can be located on or in the pad 4, in the main unit 2, in the connection block 3, or can be part of a thermal sensor 15. A sensor can measure more than one physical quantity. For example, the sensor can include a combination of a gyroscope, an accelerometer, and / or a magnetometer. Additionally, the sensor can measure one or more physical quantities of the treated skin or untreated skin.

[0144] A resistance sensor can measure skin resistance, as skin resistance can vary between patients, as can humidity—wetness and sweat can affect the resistance and thus the skin's behavior in the energy field. Skin impedance can also be calculated based on the measured skin resistance.

[0145] The information from one or more sensors can be used to generate a path in a model, e.g., a model of the human body, shown on a display of the human-machine interface 8. The path can illustrate a surface area or volume of previously treated tissue, currently treated tissue, tissue to be treated, or untreated tissue. A model can show a temperature map of the treated tissue, providing information about the previously treated tissue or the untreated tissue.

[0146] The sensor can provide information about the location of bones, inflamed tissue, or joints. Electromagnetic energy must not be directed at such tissue types, as treatment could be painful. Bones, joints, or inflamed tissue can be detected by any type of sensor, such as an imaging sensor (ultrasound sensor, IR sensor), impedance sensor, and the like. The detected presence of these tissue types can trigger general human-detectable signals or a disruption of the generation of electromagnetic energy. Bones can be detected by a change in the impedance of the tissue or by analyzing the reflected electromagnetic energy.

[0147] In one aspect, the active elements 13 can be used as the sensors described above. For example, the active element 13 (e.g., electrode) can measure the impedance before, during, or after the delivery of the radiofrequency energy. Additionally, the active element 13 (e.g., electrode) can measure the voltage or current flowing through the patient during electrical stimulation. Based on this information, it may be possible to determine the correct contact of the pad 4 or the active elements 13 (e.g., electrodes) with the patient.

[0148] The patient's skin may be pre-cooled to a selected temperature for a selected duration over at least one treatment session, wherein the selected temperature and duration of pre-cooling may be sufficient to cool the skin to at least one selected temperature below normal body temperature. The skin may be cooled to at least the selected temperature to a depth below the at least one depth for the treatment sessions, such that the at least one treatment session is substantially surrounded by cooled skin. Cooling may continue during energy application, and the duration of energy application may be greater than the heat relaxation time of the treatment sessions. Cooling may be provided by any known mechanism, including water cooling, sprayed coolant, the presence of an active solid cooling element (e.g., a Peltier cooler), or airflow cooling.A cooling element can serve as an optical element. Alternatively, the cooling element can be a spacer. Cooling can be provided during, before, or after treatment with electromagnetic energy. Pre-treatment cooling can also provide an environment for sudden heat shock, while post-treatment cooling can provide faster recovery from the heat shock. The temperature of the coolant can range from -200°C to 36°C. The temperature of the cooling element during treatment can range from -80°C to 36°C, or -70°C to 35°C, or -60°C to 34°C, or -20°C to 30°C, or 0°C to 27°C, or 5°C to 25°C. When the pad is not in contact with the patient's skin, cooling via cryospray, gas flow, or other non-contact cooling techniques can be used. A cooling gel applied to the skin surface can also be used, either in addition to or instead of one of the cooling techniques listed above.

[0149] Fig. 3A and Fig. 3B show different shapes and layouts of the pad 4 used by a contact therapy device. The pads 4 comprise at least one active element 13 (e.g., electrode) and can be available in various shapes and layouts to cover a variety of different treatment areas and meet the individual needs of patients, e.g., ring-shaped, semicircular, elliptical, oblong, square, rectangular, trapezoidal, polygonal, or amorphous (without a regular shape or form). The shapes and layouts of the pad 4 can be shaped to cover at least a portion of one or more of the periorbital area, forehead (including frown lines), jawline, perioral area (including marionette lines, perioral folds—so-called smoker's lines, nasolabial folds, lips, and chin), cheeks, or submentum, etc.The shape of the pad 4 and the distribution, size, and number of the active elements 13 (e.g., electrodes) can vary depending on the area to be treated. For example, the active elements 13 can be arranged within the pad 4 in one line, two lines, three lines, four lines, or multiple lines. The pad 4 with the active elements 13 can be arranged in various shapes, for example, in a line, with the centers of at least two active elements 13 lying in a straight line, while any additional center of an active element 13 can be located in the same or different lines within the pad 4.

[0150] Additionally, Pad 4 can be used to at least partially treat the neck, bra fat, waist fat, torso, back, abdomen, buttocks, thighs, calves, legs, arms, forearms, hands, fingers or body cavities (e.g. vagina, anus, mouth, inner ear, etc.).

[0151] In one aspect, the one or more pads 4 can be used to treat the patient's décolleté or breast, e.g., to remove wrinkles. In another aspect, the décolleté or breast can be treated with the device to push or enlarge the breasts, e.g., to stimulate breast enlargement, make the breasts fuller and healthier, and make the breasts healthy. The one or more pads 4 can improve the elasticity and fibers of muscle tissue, restore the elasticity and softness of the breasts, lift and develop the breasts, and solve problems such as sagging breasts, inverted nipples, and breast distension.

[0152] The pad 4 may have a rectangular, oblong, square, trapezoidal shape, or the shape of a convex or concave polygon, wherein the pad 4 may have at least two different interior angles of the convex or concave polygon structure. In addition, the pad 4 may at least partially have the shape of a conic section (also called a cone), e.g., a circle, an ellipse, a parabola, or a hyperbola. The pad 4 may at least partially have one, two, three, four, five, or more arcuate curvatures, wherein the curvature k is in the range from 0.002 to 10 mW. -1 or in the range of 0.004 to 5 mm -1 or in the range of 0.005 to 3 mm -1 or in the range of 0.006 to 2 mm -1The pad 4 may have at least one, two, three, four, five or more arches with the curvature k or may have at least two different interior angles of a convex or concave polygon structure and may be suitable for the treatment of the chin, cheeks, submental area (e.g., "banana shape 1" 4.2), for the treatment of the jaw line, perioral area, marionette lines 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 regions of the face and neck. The “banana-shaped” pad 4.2 or 4.4 may have a convexo-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 20% to 90% of a total circumference of the pad 4 when viewed from above, wherein the shortest distance between the end points 4.21a and 4.21b of the “banana-shaped” pad 4.2 (dashed line in Fig. 3A) is longer than the shortest distance between the end point 4.21a or 4.21b and the center point 4.22 of the “banana shape” (solid line in pad 4.2 in

[0153] Fig. 3A). The horseshoe shape 4.3 may, when viewed from above, 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 its total circumference, the shortest distance between the end points 4.31a and 4.31b of the horseshoe-shaped pad 4.3 (dashed line in Fig. 3B) is equal to or shorter than the shortest distance between the end point 4.31a or 4.31b and the center point 4.32 of the “horseshoe shape” (solid line in pad 4.3 in Fig. 3B). If, when viewed from above, the longest possible central curve, which may be convex or concave and whose normal at a given point has at each of its points the same distance from the peripheral edges of the pad (dotted line in pad 4.2 in Fig. 3A), intersects the circumference of pad 4, then this point is the end point of the pad, e.g., the end point 4.21a or 4.21b. The center point, e.g., 4.22, is then given as the center of the center curve, where the total length of the center curve is given by two end points, e.g., 4.21a and 4.21b, so that the length of the center curve (dotted line in pad 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 center curve may be in the range from 0.1 to 30 cm, or in the range from 0.5 to 25 cm, or in the range from 1 to 20 cm.

[0154] Additionally, the center curve may have an at least partially circular, elliptical, parabolic, hyperbolic, exponential, convex, or concave curve such that the straight line connecting the end point of pad 4 to the center point of the center curve forms an angle alpha with the tangent of the center of the center curve. The angle alpha may be in a range of 0.1° to 179°, or in a range of 0.2° to 170°, or in a range of 0.5° to 160°, or in a range of 1° to 150°.

[0155] The pad 4, whose shape has at least two concave arches with the curvature k or at least two concave interior angles of the polygon structure, can be suitable for the treatment of the forehead like the “T-shape” 4.1 in Fig. 3A. The "T-shape" 4.1 can also be characterized by the arrangement of the active elements 13, wherein the centers of at least two active elements 13 lie on a straight line and the center of at least one additional element 13 lies on another line.

[0156] Another possible non-limiting configuration of the pad 4 used for the treatment of the forehead is in Fig. 3C. In this non-limiting example, a forehead pad (pad 4 is used for treating the forehead) may contain two lines of active elements 13 (e.g., electrodes) - the active elements 13a-13f, as shown in Fig. 3C, wherein the active elements 13a-13f in a line may be at least partially separated by slots 43 for better flexibility of the pad 4. A first line of active elements comprises active elements (e.g., electrodes) shown in the dotted box 131a in Fig. 3C - the active elements 13d, 13e and 13f. The second line of active elements (e.g. electrodes) includes active elements shown in the dashed box 131b in Fig. 3C—active elements 13a, 13b, 13c. The dotted and dashed boxes 131a and 131b are used only to visualize the first and second lines of active elements (e.g., electrodes). Such a pad 4 may have a shape that includes a total number of convex and / or concave arcs in a range from 14 to 36, or in a range from 18 to 32, or in a range from 20 to 30, or in a range from 22 to 28 with a curvature k. In addition, the pad 4 may have a number of concave interior angles in a range of 2 to 20 or in a range of 5 to 17 or in a range of 7 to 15 or in a range of 9 to 13 or the pad 4 may have a number of convex interior angles in a range of 2 to 20 or in a range of 5 to 17 or in a range of 10 to 16 or in a range of 11 to 15.

[0157] Fig. 3C also shows the sticker 44 on a top side of the pad 4. The top side is the side opposite the bottom side (the side on which the adhesive layer or the active elements on the substrate of the pad 4 can be arranged) or, in other words, the top side is the side of the pad 4 facing away from the patient during treatment. The sticker 44 can have a bottom side and a top side, wherein the bottom side of the sticker 44 can comprise an adhesive layer and the top side of the sticker 44 can comprise a non-adhesive layer (e.g., polyimide (PI) films, PTFE (e.g., Teflon®), epoxy, polyethylene terephthalate (PET), polyamide, or PE foam).

[0158] As in Fig. 3C, the sticker 44 may have the same or a similar shape as the pad 4 with an additional overlap beyond the pad 4. The overlap is in Fig. 3C hatched. The sticker 44 can be adhered to the pad 4 such that the adhesive layer on the underside of the sticker 44 faces the top side of the pad 4. The overlap of the sticker can exceed the pad 4 in the range of 0.1 to 10 cm, or in the range of 0.1 to 7 cm, or in the range of 0.2 to 5 cm, or in the range of 0.2 to 3 cm, or in the range of 0.3 to 1 cm. This overlap can further comprise an adhesive layer and can be used to form additional and better contact of the pad 4 with the patient. In another aspect, the sticker can have a different shape or size than the pad.

[0159] The forehead pad (pad 4 is used for treating the forehead) may comprise active edge elements (e.g. electrodes) 13a, 13c, 13d and 13f and active center elements (e.g. electrodes) - 13b and 13e - as shown in Fig. 3C. The forehead pad 4 can be divided into a top side 131a with active elements (e.g., electrodes) 13d, 13e, and 13f and a bottom side 131b with active elements (e.g., electrodes) 13a, 13b, and 13c, as well as a left side with active elements (e.g., electrodes) 13a and 13f and a right side with active elements (e.g., electrodes) 13c and 13d. The active edge elements (e.g., electrodes) 13a, 13c, 13d, and 13f in the forehead pad 4, which is shown in Fig. 3C, a surface in the range of 1 to 10 cm 2 or in the range of 2 to 6.5 cm 2 or in the range of 2.3 to 6 cm 2 or in the range of 2.5 to 5.5 cm 2 which can be the same for all active edge elements. The active center elements (e.g. electrodes) 13b and 13e in Fig. 3C may have the same surface area as the active edge elements (e.g. electrodes) or may have a larger surface area than the active edge elements (e.g. electrodes), with the surface area of ​​the active center elements (e.g. electrodes) being in the range of 1 to 20 cm 2 or in the range of 2 to 15 cm 2 or in the range of 3 to 12 cm 2 or in the range of 4 to 10 cm 2 In one aspect, each active element (e.g., electrode) may have a different surface area. The ratio of the surface area of ​​a center active element (e.g., electrode) to a surface area of ​​an edge active element (e.g., electrode) on the face pad may be in the range of 0.8 to 2.5, or in the range of 1 to 2.3, or in the range of 1.1 to 2.2.

[0160] The distance d Kante between the nearest points of the active lower edge elements (e.g. electrodes) 13a and 13c in Fig. 3C or the active top edge elements (e.g. electrodes) 13d and 13f in Fig. 3C can be in the range of 2 to 8 cm or in the range of 3 to 7 cm or in the range of 4 to 6 cm or in the range of 4.5 to 5.5 cm. The distance d Kante between the active top edge elements (e.g. electrodes) and the distance d Kante between the active lower edge elements (e.g. electrodes) can be the same.

[0161] The distance dvert between the nearest points of the upper active elements (e.g. electrodes) and the lower active elements (e.g. electrodes) on one side (left, middle, right), e.g. the distance between the active elements 13a and 13f, between the active elements 13b and 13e or between the active elements 13c and 13d in Fig. 3C, can be in the range of 0.5 to 20 mm, or in the range of 1 to 10 mm, or in the range of 1.5 to 6 mm, or in the range of 2 to 5 mm. The distance dvert can be the same for the left, middle, and right active elements.

[0162] Such distances (d Kante and d vert ) are optimized to mitigate edge effects (e.g., preventing the formation of hot spots near edges) or leakage currents and effectively treat, for example, the frontalis muscle or the procerus muscle during treatment. The active edge elements (e.g., electrodes) - 13a, 13c, 13d, and 13f in Fig. 3C - are used for the treatment of the frontalis muscle and / or the corrugator supercilii muscle and the active central elements (e.g. electrodes) - 13b and 13e in Fig. 3C - are used for the treatment of the procerus muscle.

[0163] The forehead pad (pad 4 is used to treat the forehead) in Fig. 3C also shows a possible arrangement of the lower middle part of the pad 4, comprising the lower middle active element (e.g., electrode) 13b. The pad 4 can have a convex protrusion 4p and / or a concave depression in the lower middle part. Furthermore, the active element 13b can be designed in a shape corresponding to an elongated or rectangular shape with a convex protrusion 13p and / or a concave depression in the center of the lower part of the active element 13b, which copies a shape of the pad 4 with the protrusion 4p and / or the depression of the pad. This protrusion 4p and / or this depression can serve as a focal point for correct coupling of the pad 4 to the patient's forehead area, wherein the protrusion 4p and / or the depression should be aligned with the center of the patient's nose (e.g., in the center of the procerus muscle), and at the same time, the lower edge of the pad 4 should be coupled slightly above the patient's eyebrows.

[0164] A possible non-restrictive configuration of the pad 4 used for the treatment of the left cheek is shown in Fig. 3D. In this non-limiting example, the active center elements (e.g., electrodes) - the active elements 13g, 13h, 13i, and 13j - may be separated on the substrate, and the distance d Mitte between the nearest points of two adjacent active central elements (e.g. electrodes) in the range of 0.5 to 5 mm or in the range of 0.8 to 3 mm or in the range of 1 to 2.5 mm or in the range of 1.2 to 2.3 mm. Fig. The pad for the left cheek shown in 3D (pad 4 is used for the treatment of the left cheek) can be designed to be coupled to the patient in such a way that the underside of the pad 4 is aligned with the left part of the mandibular base and is slightly above it, which in Fig. 3D is represented by the number 301. The active central elements (e.g. electrodes) 13g, 13h, 13i and 13j in Fig. 3D can cover a surface in the range of 1 to 15 cm 2 or in the range of 2 to 8 cm 2 or in the range of 2.5 to 6 cm 2 or in the range of 3 to 5 cm 2 The active edge elements (e.g. electrodes) 13k, 131 and 13m can have a surface area in the range of 1 to 20 cm 2 or in the range of 2 to 10 cm 2 or in the range of 2.5 to 8 cm 2 or in the range of 3.5 to 7 cm 2 The ratio of the surface area of ​​the active edge element (e.g. electrode) - one of 13k, 131 or 13m - to the surface area of ​​the active center element (e.g. electrode) - one of 13g, 13h, 13i or 13j in Fig. 3D - can be in a range of 0.5 to 3 or in a range of 0.8 to 2.5 or in a range of 1 to 2 or in a range of 1 to 1.8.

[0165] The active middle elements (e.g. electrodes) 13g, 13h, 13i and 13j in Fig. 3D are optimally configured to mitigate edge effects (e.g., preventing the formation of hot spots near edges) or leakage currents and to treat, for example, the buccinator, risorius, zygomaticus, and / or masseter muscles. The active center elements (e.g., electrodes) 13g, 13h, 13i, and 13j in Fig. 3D devices are optimally configured to treat, for example, the platysma, depressor, and / or levator labii superioris muscles. The number of active center elements (e.g., electrodes) can range from 1 to 10, from 1 to 8, from 2 to 6, or from 2 to 4. The number of active edge elements (e.g., electrodes) can range from 1 to 10, from 1 to 7, from 1 to 6, or from 2 to 5.

[0166] Pad 4 used to treat the right cheek can be placed symmetrically to the pad shown in Fig. Pad 4 shown in 3D for the left cheek.

[0167] In one aspect, the cheek pad 4 may be symmetrical, as in Fig. 3E. Such a symmetrical cheek pad can be used for the treatment of the left or right cheek. The symmetry lies along the axis 333 (dashed line in Fig. 3E). A first line of active elements (e.g., electrodes) 13n1, 13o1, and 13p1 is located above the axis 333, and the symmetrical second line of active elements (e.g., electrodes) 13n2, 13o2, and 13p2 is located below the axis 333. Thus, the symmetrical cheek pad can have pairs of active elements (e.g., electrodes)—e.g., 13n1 and 13n2, 13o1 and 13o2, or 13p1 and 13p2—where the active elements (e.g., electrodes) in each pair have the same shape symmetrical to the axis 333. The area of ​​the active elements (e.g., electrodes) can be the same or different for all active elements (e.g., electrodes). In one aspect, all active elements (e.g., electrodes) 13n1-13p2 may have the same surface area, wherein the surface area of ​​an active element (e.g., electrode) may be in the range of 1 to 15 cm 2 , in the range of 2 to 8 cm 2 , in the range of 2.5 to 6 cm 2 or in the range of 3 to 5 cm 2In another aspect, the surface of the active elements (e.g. Electrodes) 13n1-13p2 may be different for each active element (e.g. electrode) or active pair elements (e.g. pair 13n1 and 13n2) may have the same surface area, which is different from the surface area of ​​other active pair elements (e.g. pair 13p1 and 13p2), where the surface area of ​​an active element (e.g. electrode) may be in the range of 1 to 20 cm 2 , in the range of 2 to 10 cm 2 or in the range of 2.5 to 8 cm 2 or in the range of 3.5 to 7 cm 2 can lie.

[0168] The Fig. Distance d shown in Figure 3E intr between the active elements is a distance between the two nearest points of adjacent active elements (e.g., electrodes), e.g., the active element 13o1 and the active element 13p1. The distance d intrbetween the active elements can be in the range of 0.5 to 5 mm, in the range of 0.8 to 4 mm, in the range of 1 to 3.3 mm or in the range of 1.2 to 2.8 mm. The active elements (e.g. electrodes) 13n1-13p2 in Fig. 3E are optimally configured to minimize edge effects (e.g. Preventing the formation of hot spots near edges) or attenuating leakage currents and treating, for example, the buccinator, risorius, zygomaticus, masseter, platysma, depressor and / or levator labii superioris muscles.

[0169] Another possible non-limiting configuration of the pad 4 that can be used for the treatment of the forehead is in Fig. 3F. The pad 4 may include a pair of active left edge elements (e.g., electrodes) 13q1 and 13q2 and a pair of active right edge elements (e.g., electrodes) 13s1 and 13s2. The active left edge elements (e.g., electrodes) 13q1 and 13q2 may be aligned along at least one axis, e.g., the horizontal axis 332 in Fig. 3F, be symmetrical. The active right edge elements (e.g., electrodes) 13s1 and 13s2 may be arranged along at least one axis, e.g., the horizontal axis 332 in Fig. 3F, be symmetrical. The pad 4 may have a pair of active center elements (e.g., electrodes) 13r1 and 13r2, which may be symmetrical along the horizontal axis 332 or may not be symmetrical along the horizontal axis 332, but may be symmetrical along the vertical axis 334. In fact, the entire layout of the active elements (e.g., electrodes) on the pad 4 may be symmetrical along at least one axis, e.g., the vertical axis 334 in Fig. 3F, be symmetrical.

[0170] The active elements (e.g., electrodes) may have the same or different surface areas, or active pair elements (e.g., active elements 13q1 and 13q2) may have the same surface area, which may differ from the surface area of ​​other active pair elements (e.g., active elements 13r1 and 13r2). The surface area of ​​the active element (e.g., the electrode) is in the range of 1 to 10 cm 2 or in the range of 2 to 6.5 cm 2 or in the range of 2.3 to 6 cm 2 or in the range of 2.5 to 5.5 cm 2 . The active elements (e.g. electrodes) can change the distances d Kanteand dvert between them, as described above, which are optimized to mitigate edge effects (e.g., preventing the formation of hot spots near edges) or leakage currents and, for example, to effectively treat the frontalis muscle or procerus muscle during treatment. Some active elements (e.g., electrodes) may also be at least partially separated by the slots 43 of the pad, e.g., the active elements 13r2 and 13s2 for better coupling of the pad 4 to the patient.

[0171] All in the Fig. The non-limiting examples of the pad shown in Figures 3C-3F also show the sticker 44 on a top side of the pad 4. The sticker may have the same or a similar shape as the pad 4 with an additional overlap beyond the pad 4. The overlap is shown in the Fig. 3C-3F hatched. The sticker overlap may exceed the pad 4 in the range of 0.1 to 10 cm, or in the range of 0.1 to 7 cm, or in the range of 0.2 to 5 cm, or in the range of 0.2 to 3 cm, or in the range of 0.3 to 1 cm. In one aspect, the sticker overlap may further include sticker slots 45 (see, e.g., Fig. 3E and Fig. 3F) near the pad slots 43, which allow better adhesion of the overlap of the sticker 44 to the uneven areas of the body part.

[0172] A treatment pad suitable for treating the submental region can cover both the submentum and part of the neck. In one aspect, such a submental pad can include active elements (e.g., electrodes) that deliver energy suitable for providing contractions (e.g., electrical current) only to the submentum (submental and submandibular triangle, e.g., suprahyoid muscles - mylohyoid muscles, stylohyoid muscles, geniohyoid muscles, and digastric muscles) and platysma muscles; and other active elements (e.g., electrodes) that deliver energy suitable for heating (e.g., radiofrequency) the submentum and / or the neck (e.g., carotid triangle, muscular triangle). Such a layout of the pad may be suitable for the treatment of double chin, where the heat is evenly distributed under the pad and the contractions are only directed to some submental muscles (e.g.Digastric, mylohyoid, and / or stylohyoid muscles) that may overlie the hyoid bone. In one aspect, the submental pad may be symmetrical. In one aspect, the submental pad may have a "banana shape," as described above, configured to treat the submentum in a manner that excludes the area of ​​the laryngeal protrusion from being treated with either radiofrequency energy or electrical current to avoid damage to the thyroid.

[0173] The submental pad can be configured for aesthetic treatment to improve the visual appearance, such as skin rejuvenation, wrinkle removal, rhytides, skin tightening and lifting, cellulite and fat reduction, treatment of pigmented lesions, tattoo removal, soft tissue coagulation and ablation, reduction of vascular lesions, facelift, muscle contraction and strengthening, temporary pain relief, muscle spasms, increase of local blood circulation, etc.

[0174] In another aspect, the submental pad can be configured to treat sleep apnea and / or snoring. One of the causes of snoring is the collapse of soft tissues toward the airway. Depending on the severity, this can manifest as anything from snoring (turbulent airflow, creating noise, while soft tissues are moved, also creating noise) to sleep apnea, which results in a lack of oxygen supply. In these cases, the submental pad can be configured to stimulate the genioglossus and the muscles near the airway. This stimulation increases muscle tone, allowing soft tissues to be better kept away from the airway, which can reduce sleep apnea and / or snoring.

[0175] The pads can have different sizes, with surfaces ranging from 0.1 to 150 cm 2 or from 0.2 to 125 cm 2 or from 0.5 to 100 cm2 or in the range of 1 to 50 cm 2 or in the range of 10 to 50 cm 2 or in the range of 15 to 47 cm 2 or in the range of 18 to 45 cm 2 The pad can cover approximately 1 to 99%, or 1 to 80%, or 1 to 60%, or 1 to 50% of the face. The number of active elements 13 (e.g., electrodes) within a single pad 4 is in the range of 1 to 100, or from 1 to 80, or from 1 to 60, or from 2 to 20, or from 3 to 10, or from 4 to 9. A thickness in at least a portion of the pad 4 can be in the range of 0.01 to 15 mm, or in the range of 0.02 to 10 mm, or in the range of 0.05 to 7 mm, or in the range of 0.1 to 2 mm.

[0176] In one aspect, the pad 4 may comprise an active element 13 (e.g., electrode) that provides one or more treatments (e.g., radiofrequency energy and electrical current), while a plurality of such pads may be used to treat the same area during a treatment. Instead of using one pad 4 with six active elements 13 (e.g., electrodes), which may be used to treat a forehead, for example, six pads 4, each with one active element 13 (e.g., electrode), may be used for the same treatment. In another aspect, the pad 4 may comprise one active element 13 (e.g., electrode) that provides one type of treatment / energy, and a plurality of pads 4, which provide the same or a different treatment / energy, may be used to treat the same area during a treatment. Instead of the pad 4 with one active element 13 (e.g.,electrode) that provides high-frequency energy and electric current, it is possible, for example, to use two pads 4, one with an active element 13 (e.g. electrode) that provides high-frequency energy, and the other with an active element 13 (e.g. electrode) that provides electrical current.

[0177] Alternatively, only one or more active elements 13 (e.g., electrodes) themselves may be used instead of the pad 4 with a substrate and the active element 13. In one aspect, the active element 13 (e.g., electrode), which provides one or more treatments (e.g., radiofrequency energy and electrical current), may be used to treat a part of the patient's body. In another aspect, a plurality of active elements 13 (e.g., electrodes) may be used to treat the same part of the body during a treatment. Instead of using one pad 4 with six active elements 13 (e.g., electrodes), which may be used for the treatment of a forehead, for example, six individual active elements 13 (e.g., electrodes) may be used for the same treatment. In another aspect, the active element 13 (e.g., electrode) may provide one type of treatment / energy and may include a plurality of active elements 13 (e.g.,Electrodes) providing the same or different treatment / energy can be used to treat the same area during one treatment. Instead of using the pad 4 with at least one active element 13 (e.g., electrode) providing radiofrequency energy and electrical current, it is possible, for example, to use at least two individual active elements (e.g., electrodes), at least one active element 13 (e.g., electrode) providing radiofrequency energy and at least one active element 13 (e.g., electrode) providing electrical current.

[0178] In one aspect, the active elements 13 (e.g., electrodes or coils) may at least partially overlap each other. For example, the electrode may be located at least partially below or above the coil in the pad 4.

[0179] In addition, the pads 4 can have a shape that at least partially replicates the shape of the galea aponeurotica, the procerus muscle, the levator labii superioris alaeque nasi, nasalis, the levator labii superioris, the zygomaticus minor, the zygomaticus major, the levator anguli oris, the risorius, the platysma, the depressor anguli oris, the depressor labii inferioris, the occipitofrontalis (frontal muscle), the corrugator supercilii, the orbicularis oculi, the buccinator, the masseter, the orbicularis oris or mentalis when the pad 4 is applied to the surface of the patient's skin.

[0180] The pad 4 may be characterized by at least one aspect mentioned above or by a combination of more than one aspect mentioned above or by a combination of all aspects mentioned above.

[0181] The electromagnetic energy generator 6 or secondary generator 9 inside the main housing can generate electromagnetic or secondary energy (e.g., electric current) that can be delivered via a conductive line to at least one active element 13 (e.g., electrode) applied to the skin. The active element 13 can deliver energy over its entire surface or through a so-called fractional arrangement. The active element 13 can be an active electrode in a monopolar, unipolar, bipolar, or multipolar radiofrequency system. In the monopolar radiofrequency system, the energy is delivered between an active electrode (an active element 13) and a neutral electrode 7 with a much larger surface area.Due to the mutual distance and the different surface areas of the active and neutral electrodes, the energy is concentrated under the active electrode, allowing it to heat the treated area. In the monopolar radiofrequency system, the energy can be delivered at a frequency in the range of 100 kHz to 550 MHz, or in the range of 200 kHz to 300 MHz, or in the range of 250 kHz to 100 MHz, or in the range of 300 kHz to 50 MHz, or in the range of 350 kHz to 14 MHz. In the unipolar, bipolar, or multipolar radiofrequency systems, there is no need for a neutral electrode 7. In the bipolar and multipolar radiofrequency systems, the energy is delivered between two or more active electrodes with similar surface areas. The distance between these electrodes determines the depth of penetration of the energy.Only a single active electrode is incorporated into the unipolar radiofrequency system, and the energy is delivered to the tissue and the surrounding area around the active electrode. The distance between the two nearest active elements 13 (e.g., the nearest adjacent sides of electrodes) in a pad 4 can be in the range of 0.1 to 100 mm, or in the range of 0.3 to 70 mm, or in the range of 0.5 to 60 mm, or in the range of 0.7 to 30 mm, or in the range of 1 to 10 mm, or in the range of 1 to 5 mm. The distance between the two nearest adjacent sides of the electrodes can be the distance between the two nearest points of the adjacent electrodes.

[0182] A distance between the nearest point of the active element 13 (e.g. electrode) and the nearest edge of the pad 4 may be in the range of 0.1 to 10 mm or in the range of 0.5 to 5 mm or in the range of 1 to 4 mm or in the range of 1 to 3 mm.

[0183] The Fig. 4A-D depict a side view of possible configurations of the pad 4 configured for contact therapy. The pads 4 can be made of a flexible carrier material 42—polyimide (PI) films, PTFE (e.g., Teflon®), PET, epoxy, or PE foam—with an additional adhesive layer 40 on the underside. They can have different shapes to allow an operator to select according to the area to be treated. Active elements 13 (e.g., electrodes) can have a circumference of annular, semicircular, elliptical, oblong, square, rectangular, trapezoidal, or polygonal shape with a surface area in the range of 0.1 to 70 cm2 or from 0.5 to 50 cm 2 or from 1 to 25 cm 2 or from 1 to 10 cm 2 or from 2 to 9.5 cm 2 or from 2.5 to 9 cm 2 The material used for the active elements (e.g., electrodes) can be copper, aluminum, lead, or another conductive medium that can be disposed on or integrated into the pad 4. Furthermore, the active elements 13 (e.g., electrodes) can be made of silver, gold, or graphite. The electrodes in the pad 4 can be printed using biocompatible ink, such as silver ink, graphite ink, or a combination of inks made of different conductive materials.

[0184] In some aspects, the active elements 13 (e.g., electrodes) may also be flexible. A stiffness of the pad 4, the flexible substrate, or the active elements 13 (e.g., electrodes) may be in a range from Shore 0010 to Shore D80, in a range from Shore 0030 to Shore A100, in a range from Shore A10 to Shore A80, or in a range from Shore A20 to A70. In another aspect, the pad 4 may be made of a flexible substrate with rigid active elements 13 (e.g., electrodes), or some active elements 13 (e.g., electrodes) may be rigid and some may be flexible, with the aforementioned Shore ranges (e.g., RF electrodes may be rigid and the electrodes for electrotherapy may be flexible, and vice versa).

[0185] In one aspect, the active elements 13 (e.g., electrodes) suitable for one treatment (e.g., radiofrequency) may have different shapes and surfaces than the active elements 13 (e.g., electrodes) suitable for a second treatment (e.g., electrical current). For example, the radiofrequency electrodes may have a larger surface area than the electrotherapy electrodes.

[0186] The thickness of the active elements 13 (e.g., electrode) can be in the range of 1 µm to 500 µm, in the range of 2 µm to 400 µm, in the range of 3 µm to 300 µm, or in the range of 5 µm to 100 µm. In another aspect, the electrode thickness can be in the range of 0.2 mm to 10 mm, in the range of 0.4 mm to 8 mm, or in the range of 0.5 mm to 5 mm.

[0187] In one aspect, the active elements 13 (e.g., electrodes) may have a sandwich structure in which several conductive materials are arranged gradually on top of one another, e.g., a copper-nickel-gold structure. The copper may, for example, be arranged on the substrate with a thickness in the range of 5 to 100 µm, or in the range of 15 to 55 µm, or in the range of 25 to 45 µm. The nickel may be arranged on the copper with a thickness in the range of 0.1 to 15 µm, or in the range of 0.5 to 8 µm, or in the range of 1 to 6 µm. And the gold may be arranged on the nickel with a thickness in the range of 25 to 200 nm, or in the range of 50 to 100 nm, or in the range of 60 to 90 nm. Such a sandwich structure can, for example, be produced using an ENIG process.

[0188] In another aspect, the active elements 13 (e.g., electrodes) may be made of copper and covered with another conductive layer, e.g., silver or silver chloride ink, carbon paste, or aluminum segments coupled to the copper by a conductive adhesive. In yet another aspect, the electrodes may be printed, e.g., with a silver ink or silver chloride ink or a carbon paste, with the electrode thickness in the range of 1 to 100 µm, or in the range of 5 to 55 µm, or in the range of 8 to 45 µm.

[0189] The active element 13 (e.g., electrode) may have a shape having a total number of convex or concave arcs in a range from 1 to 12, or in a range from 2 to 10, or in a range from 3 to 9, or in a range from 4 to 8. In addition, the active element (e.g., electrode) may have a number of concave interior angles in a range from 1 to 7, or in a range from 1 to 6, or in a range from 1 to 5, or in a range from 2 to 4, or the active element (e.g., electrode) may have a number of convex interior angles in a range from 1 to 10, or in a range from 1 to 9, or in a range from 2 to 8, or in a range from 3 to 7. A possible arrangement of convex-concave active elements 13 (e.g., electrodes) is shown in Fig. 3C.

[0190] The active element 13 (e.g., the electrode that provides radiofrequency energy and / or electrical current) may be a full-surface electrode having a full active surface. This means that the entire patient-facing surface of the electrode is made of conductive material, which, as mentioned above, is disposed on or integrated into the pad 4.

[0191] In one aspect, the patient-facing electrode (made of conductive material) may, for example, have one or more passages, cutouts, and / or protrusions that may, for example, be used to improve the flexibility of the electrode and / or pad and / or to reduce edge effects and / or to improve the homogeneity of the density of the delivered energy and / or to improve the homogeneity of the delivered

[0192] treatment. The passages can be an opening in the body of the electrode. A cutout can be an opening in the body of the electrode along the boundary of the electrode. Openings in the body of the electrode can be defined by a view of ground projections showing a view of the electrode from above. The openings, e.g., passages, cutouts, and / or areas outside the protrusions can be filled with air, dielectric material, insulating material, the substrate of the pad, air, or hydrogel. The electrode is therefore segmented by a discontinuity in the surface compared to a regular electrode (i.e., an electrode without passages and cutouts). The two or more passages or cutouts of the one electrode can be asymmetric. The one or more passages and cutouts can, for example, be rectangular or circular.The apertures and / or cutouts may have regular, irregular, symmetrical, and / or asymmetrical shapes. If the electrode has two or more apertures or cutouts, the apertures or cutouts may share the same point of symmetry and / or the same line of symmetry. The distance between the two nearest points located at the edges of two different apertures and / or cutouts of the electrode may range from 1 μm to 10 mm, or from 10 μm to 8 mm, or from 20 μm to 5 mm, or from 50 μm to 3 mm, or from 100 μm to 2 mm.

[0193] The active element (e.g., the electrode) having one or more openings (e.g., vias and / or cutouts) and / or protrusions may be framed by the conductive material, and the interior of the frame may comprise a combination of conductive material and the openings. As shown in the Fig. As shown in Figures 9A-9C and 9I, the frame 801 may form the outermost periphery of the electrode 800 from the side facing the patient. The frame 801 may have an annular, semicircular, elliptical, oblong, square, rectangular, trapezoidal, or polygonal shape. The interior of the frame 801 may have the structure of a grid 802, as shown in Fig. 9A and Fig. 9B with the passages 803. The frame 801 and the grid lines 802 are made of conductive material and are part of the electrode 800. The frame 801 can have the same thickness as the thickness of the grid lines 802 or the thickness of the frame 801 can be thicker than the grid lines 802 in the range of 1% to 2000% or in the range of 10% to 1000% or in the range of 20% to 500% or in the range of 50% to 200%. In addition, the frame 801 may be 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 thinner than the raster lines 802.

[0194] The thickness of the frame 801, as in the Fig. 9A-9C and Fig. 9I, may be in a range of 0.1 to 5 mm, in a range of 0.5 to 2.3 mm, in a range of 0.6 to 1.9 mm, or in a range of 0.8 to 1.6 mm. The thickness of the grid lines 802, as shown in the Fig. 9A-9I, the thickness may be in a range of 0.01 to 2.3 mm, in a range of 0.05 to 1.1 mm, in a range of 0.1 to 0.8 mm, or in a range of 0.2 to 0.6 mm. The thickness of the frame 801 and the grid lines 802 is in Fig. 9I, which is a zoom view of the electrode 800 with the frame 801, the grid lines 802, and the vias 803. It may also be possible to design the electrode such that the conductive material of the electrode becomes thinner from the center 804 of the electrode 800, as in Fig. 9C. The thinning step between adjacent raster lines 802 in the direction from the center 804 to the frame 801 may be in the range of 0.1 to 10 times, or in the range of 0.2 to 5 times, or in the range of 0.5 to 2 times, with the frame 801 having the thinnest line of conductive material.

[0195] In a first aspect, the total area of ​​the electrode 800 (comprising the frame 801 and the grid lines 802) and all passages 803 within the frame 801 of the electrode 800 can be in the range of 1 to 15 cm 2 or in the range of 2 to 8 cm 2 or in the range of 2.5 to 6 cm 2 or in the range of 3 to 5 cm2 lay.

[0196] In a second aspect, the total area of ​​the electrode 800 (comprising the frame 801 and the grid lines 802) and all passages 803 within the frame 801 of the electrode 800 can be in the range of 1 to 20 cm 2 or in the range of 2 to 10 cm 2 or in the range of 2.5 to 8 cm 2 or in the range of 3.5 to 7 cm 2 lay.

[0197] In a third aspect, the total area of ​​the electrode 800 (comprising the frame 801 and the grid lines 802) and all passages 803 within the frame 801 of the electrode 800 can be in the range of 1 to 10 cm 2 or in the range of 2 to 6.5 cm 2 or in the range of 2.3 to 6 cm 2 or in the range of 2.5 to 5.5 cm 2 lay.

[0198] In a fourth aspect, the total area of ​​the electrode 800 (comprising the frame 801 and the grid lines 802) and all passages 803 within the frame 801 of the electrode 800 may be in the range of 1 to 20 cm 2 or in the range of 2 to 15 cm 2 or in the range of 3 to 12 cm 2 or in the range of 4 to 10 cm 2 lay.

[0199] The ratio of the area of ​​the conductive material of the electrode 800 (i.e., the frame 801 and the grid lines 802) to the total area of ​​all vias within the frame 801 of the electrode 800 may be in the range of 1% to 50%, or in the range of 2% to 45%, or in the range of 5% to 40%, or in the range of 8% to 35%, or in the range of 10% to 33%. Additionally, the ratio 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%.

[0200] Alternatively, the electrode 800 may not be framed, e.g., it may have a grid shape without boundaries formed by openings 803, as in Fig. 9D. A ratio of the conductive material to cutouts and / or apertures of the electrode may be in the range of 1% to 50%, or in the range of 2% to 45%, or in the range of 5% to 40%, or in the range of 8% to 35%, or in the range of 10% to 33%. Additionally, the ratio of conductive material to electrode openings can range from 1% to 20%, or from 10% to 40%, or from 33% to 67%, or from 50% to 70%, or from 66% to 100%. Such a gridded electrode can be very advantageous. It can be much more flexible, it can ensure better contact with the patient, and it can have much better self-cooling properties than the full-surface electrode.

[0201] With reference to Fig. 9E, a distance between the two nearest parallel grid lines 802a and 802b may be illustrated by at least one circle 820, which may hypothetically be entered into an opening and / or a cutout 803 and between the two nearest parallel grid lines 802a and 802b and may have at least one tangent point lying on the first grid line 802a and at least one tangent point lying on the second grid line 802b, and thus has a diameter equal to the distance between the two nearest parallel grid lines 802a and 802b. The at least one hypothetical circle 820 may have a diameter in a range of 0.001 to 10 mm or 0.005 mm to 9 mm or 0.01 mm to 8 mm or 0.05 mm to 7 mm or 0.1 mm to 6 mm or 0.2 mm to 5 mm or 0.3 mm to 5 mm or 0.5 mm to 5 mm.

[0202] With reference to Fig. 9F, in one aspect, an electrode 800 may include a plurality of protrusions in the form of radial conductive lines 808 separated by cutouts 803, wherein the plurality of radial conductive lines 808 protrude from a point of the electrode 805. The plurality of radial conductive lines 808 merge near the point 805 of the electrode and together create a solid conductive surface 810 around the point 805 of the electrode. The radial conductive lines 808 protruding from the point 805 may have the same length or may have different lengths. Additionally, some of the radial conductive lines 808 protruding from the point 805 may have the same length and some may have different lengths.

[0203] With reference to Fig. 9G, in another aspect, the electrode 800 may include a base portion 806 of a defined shape and protrusions (radial conductive lines) 808 separated by cutouts 803. The base portion 806 may have an annular, semicircular, elliptical, oblong, square, rectangular, trapezoidal, or polygonal shape. The base portion 806 may be connected to the conductive lines.

[0204] With reference to Fig. 9H, in yet another aspect, the electrode 800 may include a conductive base line 807 and a plurality of protrusions (radial conductive lines) 808 separated by the cutouts 803. The conductive base line 807 is connected to all of the radial conductive lines 808, as shown in Fig. 9H. The conductive base line may also be connected to the conductive line. The radial conductive lines 808 extending from the conductive base line 807 may have the same length and / or may have different lengths.

[0205] The distance between two nearest protrusions 808 may be illustrated as at least one circle (similar to circle 820 in Fig. 9E), which can hypothetically be entered into a passage and / or a cutout 803 and between two nearest protrusions 808 and can have at least one tangent point lying on the first protrusion and at least one tangent point lying on the second protrusion, such that it has a diameter corresponding to the distance between the two nearest protrusions. The at least one circle can have a diameter in a range from 0.001 to 10 mm, or 0.005 mm to 9 mm, or from 0.01 mm to 8 mm, or 0.05 mm to 7 mm, or from 0.1 mm to 6 mm, or from 0.2 mm to 5 mm, or from 0.3 mm to 5 mm, or from 0.5 mm to 5 mm.

[0206] The protrusions 808 or cutouts 803 may have a symmetrical, asymmetrical, irregular, and / or regular shape. The size, shape, and / or symmetry of the individual radial conductive lines may be the same and / or different across the entire electrode. For example, each protrusion 808 may have the same shape, dimension, direction, and / or symmetry. The protrusions 808 may be characterized by a thickness and a length of the protrusion, where the length is greater than the thickness by a factor in the range of 2 to 100, or in the range of 4 to 80, or in the range of 5 to 70. The thickness of a projection may be in the range of 1 µm to 5 mm or in the range of 20 µm to 4 mm or in the range of 50 µm to 3 mm or in the range of 100 µm to 2.5 mm or in the range of 120 µm to 2 mm or in the range of 150 µm to 1.5 mm or in the range from 200 µm to 1 mm. The length of the protrusions can be in the range from 0.05 to 50 mm or in the range from 0.1 to 30 mm or in the range from 0.5 to 20 mm. The number of protrusions that an electrode can comprise can be in a range from 1 to 1000 or from 5 to 500 or from 10 to 300 or from 15 to 250 or from 20 to 240.

[0207] The surface of the electrode 800 with the projections 808 can be in the range of 0.1 to 10 cm 2 or in the range of 0.3 to 9.5 cm 2 or in the range of 0.4 to 9 cm 2 or in the range of 0.5 to 8.5 cm 2 lay.

[0208] In addition, all Fig. 9F-H may be framed with a conductive frame 801, such as shown in Fig. 9A, where the frame 801 is also part of the electrode.

[0209] The total number of passages and / or cutouts in an electrode, regardless of the parallel cuts, may range from 5 to 250 or from 10 to 200 or from 15 to 170 or from 20 to 150 or from 300 to 1500 or from 400 to 1400 or from 500 to 1300 or from 600 to 1200.

[0210] In one aspect, wherein one or more active elements are in the form of an electrode that is gridded ( Fig. 9A-9D), the energy flux of one or more gridded electrodes can be calculated as the energy flux of the grid 802 and / or the frame 801 of the active element and can be in the range of 0.001 W / cm 2 up to 1500 W / cm 2 or 0.01 W / cm 2 up to 1000 W / cm 2 or 0.5 W / cm 2 up to 500 W / cm 2 or 0.5 W / cm 2 up to 200 W / cm 2 or 0.5 W / cm 2 up to 100 W / cm 2 or 1 W / cm 2 up to 70 W / cm 2 lay.

[0211] In another aspect, in which one or more active elements are in the form of an electrode with openings and / or projections ( Fig. 9F-9H), the energy flux of one or more electrodes with protrusions can be calculated as the energy flux of the base part 806 or the conductive base line 807 and the protrusions 808 of the active element and can be in the range of 0.001 W / cm 2 up to 1500 W / cm 2 or 0.01 W / cm 2 up to 1000 W / cm 2 or 0.5 W / cm 2 up to 500 W / cm 2 or 0.5 W / cm 2 up to 200 W / cm 2 or 0.5 W / cm 2 up to 100 W / cm 2 or 1 W / cm 2 up to 70 W / cm 2 lay.

[0212] As in the Fig. 4A and Fig. 4B, the active elements 13 (e.g., electrodes) may be partially embedded in the flexible substrate layer 42 or the adhesive layer 40, or in the interface between the flexible substrate layer 42 and the adhesive layer 40. The active elements 13 (e.g., electrodes) may be independently powered and controlled by multiple conductive lines 41a ( Fig. 4A) or they can be conductively interconnected and supplied / controlled via a single conductive line 41b ( Fig. 4B). The plurality of conductive lines 41a may be connected to the active elements 13 (e.g., electrodes) via a free space (e.g., a hole) in the flexible substrate layer 42. The free space (e.g., hole) may have dimensions such that each conductive line 41a can fit tightly into the substrate layer 42, e.g., the conductive line 41a may be encapsulated by a flexible substrate layer 42. Furthermore, the free space (e.g., hole) may itself be metallized and serve as a connection between the respective conductive lines 41a and the active elements 13 (e.g., electrodes). As shown in Fig. 4A, the active elements 13 (e.g., electrodes) may also be arranged on the underside of the flexible substrate 42 and may be covered by the adhesive layer 40 on the sides not coupled to the substrate 42.

[0213] In another aspect, the active elements 13 (e.g., electrodes) may be embedded in the flexible substrate 42 such that the bottom side of the substrate 401 and the bottom side of the active elements 13A-D are in a plane, as shown in Fig. 4C. For clarity, the flexible substrate 42 is shown in Fig. 4C. The substrate 42 may not have free space for the conductive lines 41a, since the conductive line may be directly coupled to the top of the active element (e.g., electrode), as in the active elements 13A and 13B in Fig. 4C. Alternatively, the flexible substrate may have a free space (e.g., hole or metallized hole) for coupling the conductive lines 41a to the active elements (e.g., electrodes), which may be thinner than the substrate, as in the active elements 13C and 13D in Fig. 4C shown.

[0214] Another possible arrangement of the active elements (e.g. electrodes) in pad 4 is shown in Fig. 4D. In a first aspect, the active element 13E can be arranged on the top surface of the substrate 402 such that the bottom surface of the active element 13E is arranged on the top surface of the substrate 402, thereby creating an interface between the active element 13E and the substrate 42 on the top surface of the substrate 402. In a second aspect, the active element 13F can be embedded into the substrate 42 from the top surface of the substrate 402 such that the top surface of the active element (e.g., electrode) and the top surface of the substrate 402 lie in a plane. In this case, the thickness of the active element 13F is less than the thickness of the substrate 42. In a third aspect, the active element 13G can be arranged on the top surface of the surface 402 similar to the active element 13E, but furthermore, the active element 13G is partially embedded into the substrate 42 from the top surface of the substrate.In all these cases (active elements 13E-G), the substrate 42 is perforated, which enables the coupling of the adhesive layer 40 to the active elements 13E-G through the perforations 403.

[0215] Alternatively, the active element (e.g., electrode) can be completely embedded in the substrate and protrude from its top or bottom surface. Thus, the thickness of the active element (e.g., electrode) can be greater than the thickness of the substrate.

[0216] In addition, combinations of the above-mentioned structures of the pad 4 may also be possible, e.g., an active element (e.g., first electrode) is arranged on the underside of the pad 4 and another active element (e.g., second electrode) is embedded in the pad 4.

[0217] In the case of a single conductive line connection, the active elements 13 (e.g., electrode) may be partially embedded in the flexible substrate 42 or the adhesive layer 40 or in the interface between the flexible substrate layer 42 and the adhesive layer 40, and the active elements 13 (e.g., electrode) may be connected via a single conductive line 41b, which may be located in the flexible substrate 42 or at the interface between the flexible substrate 42 and the adhesive layer 40, as shown in Fig. 4B. The single conductive line 41b may exit the pad 4 at its lateral or top surface in a direction away from the patient. In either case, the conductive line 41a or 41b does not come into contact with the treatment area.

[0218] In addition, the active elements 13 (e.g., the electrode) may be partially embedded in the flexible substrate 42 and the adhesive layer 40 may surround the active elements 13, so that a surface of the active elements 13 may be at least partially in direct contact with the surface of a treatment area.

[0219] In addition, the top side of the pad 4 can be protected by a cover layer 410, which for the sake of simplicity is only shown in Fig. 4C is shown.

[0220] In one aspect, all layers from the top to the bottom may be as in Fig. 4E, where the underside is the part that faces the patient during therapy. Layer 451 is an upper non-adhesive portion of the sticker 450. Layer 452 is a lower adhesive portion (e.g., medical-grade foam tape) of the sticker that attaches the sticker 451 to the substrate 421 (e.g., PET-based) of the pad 420 and / or attaches the sticker 451 to the patient. On the underside of the substrate 421, there may be a conductive line 422 separated from the active element (e.g., electrode) 424 by N dielectric layers 423-1 to 423-N (where N is a non-negative integer) with the same or different dielectric properties. The active element 424 (e.g., electrode) may be connected to the pad 420 via the hole connection 425 in the dielectric layer(s) shown in Fig. 4E is hatched, connected to the conductive line 422. The active element 424 (e.g., electrode), the conductive line 422, and the hole connection 425 can be printed with the same biocompatible material, such as silver ink, silver chloride ink, or graphite ink, or a combination of inks made of different conductive materials, or they can be fabricated using any other known technology for depositing conductive materials (e.g., lithography). The adhesive layer (e.g., hydrogel) 430 can be deposited on the underside of the active element 424 (e.g., electrode) and may be covered by a releaser 440 which is removed before the pad is applied to the patient.

[0221] In other aspects, the layers may be different and it may be possible to separate layers from the structure of the pad 420 that are in Fig. 4E. For example, as described above, the adhesive layer 430 (and the release agent 440) may not be part of the pad 420, but rather the adhesive layer 430 may be applied directly to the patient's skin before the pad 420 is coupled to the patient. In another aspect, the sticker 450 may not be shown on the pad 420. In yet another aspect, the substrate 421 and / or the dielectric layer(s) 423-1-423-N may not be part of the pad 420. Furthermore, in one aspect, only the active element 424 with the conductive line 422 may be part of the pad 420. The aspects may be combined.

[0222] A pad 4 may include a flexible substrate 500 comprising a central part 501 and one or more segments 502 that can move at least partially independently of each other, as shown in Fig. 5A. The flexible substrate may have a thickness in a range of 1 to 500 µm or in a range of 1 to 350 µm or in a range of 1 to 200 µm or in a range of 5 to 100 µm or in a range of 10 to 75 µm or in a range of 15 to 65 µm. The central part or the segments may include a sensor 15. The number of segments on the pad 4 may be in the range of 1 to 100 or in the range of 1 to 80 or in the range of 1 to 60 or in the range of 2 to 20 or in the

[0223] The number of segments can be in the range of 3 to 10 or in the range of 4 to 9, wherein each segment can comprise at least one active element 13 (e.g., an electrode). The adjacent segments can be at least partially separated by slots 503.

[0224] Conventional therapy pads are routinely manufactured on a single, non-segmented substrate, which in some cases includes a flexible metal material or a polymer material with a layer of metallic material disposed thereon.

[0225] As in Fig. 5A, the proposed segmented pad 4 may be more flexible and may provide a greater degree of contact with the patient than conventional pads that are routinely used. The substrate 500 of the pad 4 is divided into a central part 501 and a plurality of connected segments 502. The plurality of segments 502 may move at least partially independently of one another. The individual segments 502 may be at least partially separated from one another by, for example, one or more slots 503 or other open area between adjacent segments 502. The plurality of segments 502 may be physically coupled together by a central part 501, including one of a plurality of conductive lines 506. In one aspect, the central part 501 may further include one or more active elements 13 (e.g., electrodes). In another aspect, each active element 13 (e.g.,Electrode) may be arranged partially in the central part 501 and partially in the corresponding segment 502. In another aspect, some active elements (e.g., electrodes) may be arranged on the central part, and some active elements (e.g., electrodes) may be arranged at least partially on the segments.

[0226] As in Fig. 5A, the slots 503 may extend from the central portion 501 of the substrate 500 of the pad 4 near a conductive line 508 and between adjacent segments 502 to an edge of the substrate 500. Providing the plurality of segments 502 of the pad 4 to move at least partially independently of one another may facilitate conforming the pad 4 to the curves or contours of a patient's body. A segmented pad 4, as shown in Fig. 5A, may provide a larger area or a larger percentage of the total area of ​​the portion of the pad 4 in contact with the patient's body than if the pad 4 were formed as a single, non-segmented substrate. In addition, the segments 502 may Fig. 5A, which also provides better adaptation of the pad 4 to the curves or contours of a patient's body.

[0227] The shapes and positions of the segments 502 and / or the slots 503 may be in other than those shown in Fig. 5A. The segments 502 may, for example, include rounded or square ends or have different dimensional relationships than illustrated. The slots 503 may be curved, square, triangular, elongated, polygonal, or may include re-entrant sections extending between one of the segments 502 and the central part 501. The slots 503 may also be a combination of the aforementioned shapes, e.g., a combination of a triangular slot with the curved end, as shown in Fig. 5B, which shows a detail of a possible slot arrangement between two adjacent segments 502' and 502". The slots can be very narrow or can be wide, wherein the width of the slot t Scan be illustrated in an example as follows: First, an imaginary curved or straight line 520 runs through the center of the slot, dividing the slot into two symmetrical parts 503a and 503b, respectively. The width is then given by a second imaginary line 530, which is perpendicular to the first imaginary line 520 and which would connect the edges of the adjacent segments facing the slot 502a and 502b, and wherein the second imaginary line 530 is at least 1 mm away from the beginning of the slot 503c. The beginning of the slot 503c is a point in the slot 503 that is closest to the central part 501 of the substrate 500 of the pad 4, as in Fig. 5B. The first imaginary line 520 is in Fig. 5B is represented by a dashed line and the second imaginary line 530 is in Fig. 5B is shown as a dotted line. The width of the slit w can be in the range from 100 µm to 10 mm, or in the range from 500 µm to 8 mm, or in the range from 600 µm to 7 mm, or in the range from 800 µm to 5 mm.

[0228] Each segment 502 of the substrate 500 may include an active element 13 (e.g., electrode) on a portion or the entirety of the segment 502.

[0229] The central part 501 may have a proximal end 504 and a distal end 505, wherein the proximal end 504 of the central part 501 may extend through or be connected to the connecting part 507. The central part 501 is connected to the connecting part 507 in the region of the dotted circle in Fig. 5A. The connecting part 507 can have a conductive line 508 for each active element 13 (e.g. Electrode) 13a-13f in Fig. 5A or the sensor(s) 15 contained in a pad 4, wherein all conductive lines 508 of the connecting part 507 enter the pad 4 in the proximal end 504 of the central part 501 of the pad 4. The conductive lines 508 are mainly guided through the central part 501 until they reach the respective segment and the active element(s) or the sensor(s), thus no conductive line may be present at the distal end 505 of the central part 501, as in Fig. 5A. The conductive lines 506 may be routed on the top side of the substrate 500 (e.g., the side facing away from the patient) and may be covered with a cover layer (e.g., made of a synthetic polymer such as polyimide). In one aspect, the underside of the pad 4 (the side facing the patient's body area) may also be at least partially covered by the cover layer, primarily in the area where the pad 4 is coupled to the connecting part 507 - dotted circle in Fig. 5A - thereby bypassing the active elements 13; this serves, among other advantages, to improve the mechanical reinforcement of this portion of the pad 4. The cover layer (e.g., polyimide film or foam) may have a thickness in a range of 5 to 50 µm, or in a range of 7 to 35 µm, or in a range of 10 to 30 µm. In another aspect, the conductive lines 506 may be routed on the underside of the substrate 500 (e.g., the side facing the patient) and covered with a dielectric layer to prevent contact of the conductive lines 506 with the patient (e.g., the cover layer of polyimide film or foam).

[0230] The connecting part 507 can be flexible or partially elastic. The connecting part can be made of a flexible PCB with a cover layer as an insulating layer on the top and / or bottom of the connecting part 507.

[0231] In one aspect, the connecting part 507 may be printed on the substrate made of the same material as the substrate 500 of the pad, and it may be printed on the underside of the substrate 500 (e.g., with metallic ink) and covered by the cover layer so that it does not come into contact with the patient.

[0232] The connecting part may have a connector at its ends, which may be rigid. The connector may be any of USB Type A, USB Type B, USB Type C, USB Micro B, DC power cord, AC power cord, computer power cord, Firewire, RJ11, fiber connector, USB 3.0, mini display, pin connector, SMA, DVI, BNC, IDE, PS / 2, RCA, DisplayPort, PSU, SATA, mSATA, DB9, RJ45, RS232, or any other connector known in the art. The pin connector may have a number of pins in a range of 5 to 60, or in a range of 10 to 44, or in a range of 15 to 36, or in a range of 20 to 34. Alternatively, the connector may be manufactured on the flexible PCB with a stiffener attached underneath to rigidify the connector against out-of-plane deformation. The stiffener may be made of a non-conductive material, including, but not limited to, plastic or fiberglass.The stiffener may have a thickness in a range of 0.1 to 5 mm, or in a range of 0.5 to 2 mm, or in a range of 1 to 1.5 mm. The flexible PCB connector may comprise a number of contacts in a range of 5 to 60, or in a range of 10 to 44, or in a range of 15 to 36, or in a range of 20 to 34.

[0233] In one aspect, the pad 4, the connecting part 507 and the connector can all be part of the applicator.

[0234] The connection block 3 or the main unit 2 can comprise one or more sockets configured to connect the connecting part via the connector on the opposite side to the side on which the pad 4 is located, wherein the one or more sockets are configured to connect any pad and / or any applicator. Alternatively, the connection block or the main unit can comprise multiple sockets, each socket configured to connect a specific pad and / or applicator for a specific treatment area. The socket can be configured to automatically determine a currently connected pad and / or applicator. The information about the connected pad and / or applicator can be read from the memory of the pad. Alternatively, the memory can be part of the connector.After connection, the connector can be linked to the control unit 11 (e.g., CPU). The control unit 11 (e.g., CPU) can provide the user with one or more predetermined treatment protocols via the human-machine interface 8 after the pad has been detected in the socket. For example, if only one forehead pad is connected, the system can automatically detect that specific pad and suggest treatment only for the patient's forehead, without allowing the user to stop treatment of other parts of the patient's body. Furthermore, the connector can include cutouts, grooves, slots, holes, and / or notches to lock the connector in the socket. The socket can also include a safety feature that prevents accidental connection of the connector in the socket.

[0235] In one aspect, the connector may include a symbol indicating which body part the pad and / or applicator is intended to treat.

[0236] In addition, a supplementary connection between the main unit 2 and the connecting part or between the connecting block 3 and the connecting part can be used to extend the connection between the main unit 3 and the pad 4 or the connecting block 3 and the pad 4.

[0237] The average pad thickness can be in the range of 10 µm to 2000 µm or in the range of 50 µm to 1000 µm or in the range of 80 µm to 300 µm or in the range of 100 µm to 200 µm.

[0238] The device, configured in a fractionated arrangement, may comprise the active element 13 (e.g., electrode) comprising a matrix formed by active points of defined size. These points are separated by inactive (and therefore untreated) areas that allow for faster healing of the tissue. The surface containing active points may comprise from 1 to 99%, or from 2 to 90%, or from 3 to 80%, or from 4 to 75% of the total surface area of ​​the active element (active and inactive surface). The active points may have blunt ends on the tissue contact side that do not penetrate the tissue, with the tissue-contacting surface having a surface area in the range of 500 µm 2 up to 250,000 µm 2 or in the range of 1000 µm 2 up to 200,000 µm 2 or in the range of 200 µm 2 up to 180,000 µm 2 or in the range of 5000 µm 2 up to 160,000 µm 2The blunt end may have a radius of curvature of at least 0.05 mm. The diameter of the tissue-contacting surface of an active point may be in the range of 25 µm to 1500 µm, or in the range of 50 µm to 1000 µm, or in the range of 80 µm to 800 µm, or in the range of 100 µm to 600 µm.

[0239] Additionally, the device can employ a safety system that includes heat sensors and circuitry capable of adjusting the therapy parameters based on the measured values. Depending on the number and distribution of the active elements 13 (e.g., electrodes), one or more heat sensors can be integrated into the pad 4 to collect data from different points to ensure homogeneous heating. The data can be collected directly from the treatment area or from the active elements 13 (e.g., electrodes). If uneven heating or overheating is detected, the device can notify the operator and simultaneously adjust the therapy parameters to avoid burns to the patient. The treatment parameters of one or more active elements (e.g., electrodes) can be adjusted.The main therapy parameters are power, duty cycle, and time period, which regulate switching between multiple active elements 13 (e.g., electrodes). Therapy can be automatically stopped if the temperature rises above the safety threshold.

[0240] In addition, an impedance measurement can be incorporated to monitor the correct contact of the active element 13 (e.g., electrodes) with the skin. If the impedance value is outside the permissible limits, therapy can be automatically interrupted and the operator can be informed of possible contact problems. In this case, the active element (e.g., electrode) itself can serve as an impedance sensor. The impedance of one or more active elements (e.g., electrodes) of the pad can be measured before, during, or after treatment.

[0241] In one aspect, the measurement of the voltage pulses and / or the current pulses and / or the phase shift can be used to monitor the progress of the electrical current therapy. As a non-limiting example, the electrical current pulses can have a rectangular shape, and the corresponding measured voltage pulses can have a shape that depends on the amount of current flowing through the patient. Thus, it may be possible to determine the correct contact of the active element 13 (e.g., electrode) with the patient based on the measurement of the voltage pulses.

[0242] The control unit 11 (e.g., CPU) may be incorporated into the pad 4 itself or it may be a separate part conductively connected to the pad 4. In addition to the control mechanism, the control unit 11 (e.g., CPU) may also contain key indicators (e.g., ongoing therapy, actual temperature, and contact of the active element with the skin).

[0243] Fig. Figure 6 shows some of the facility’s delivery approaches for contact therapy.

[0244] It is possible to switch between multiple active elements 13 (e.g., electrodes) within the single pad 4 such that the multiple active elements 13 release energy simultaneously, successively, or in an overlapping process, or any combination thereof. For example, in the case of two active elements: In the simultaneous process, both active elements (e.g., electrodes) are used simultaneously during the time interval of, for example, 1-20 s. In the successive process, the first active element (e.g., first electrode) is used during the first time interval, for example, from 1 s to 10 s. The first active element is then stopped, and the second active element (e.g., second electrode) is used immediately in a subsequent time interval, e.g., from 10 s to 20 s. This successive step can be repeated. In the overlapping process, the first active element (e.g., first electrode) is used during one time interval, e.g., for 1-10 s, and the second active element (e.g., second electrode) is used in a second overlapping time interval, e.g., for 1-10 s, wherein during the second time interval, the first active element and the second active element overlap, e.g., with a total time for the overlapping process of 0.1-9.9 s. The active elements 13 (e.g.,

[0245] Electrodes) can deliver energy sequentially in a predefined switching sequence or randomly, as set by the operator via the human-machine interface 8. Scheme I in Fig. Figure 6 illustrates the switching between pairs / groups of non-adjacent active elements 13 (e.g., electrodes) located within a pad 4. Each pair / group of active elements 13 (e.g., electrodes) emits energy for a predefined period of time (dark gray elements in Fig. 6 - in Scheme I, elements 1 and 3), while the remaining pairs / groups of active elements 13 (e.g. electrodes) remain inactive with respect to energy release (light grey elements in Fig. 6 - in Scheme I, elements 2 and 4). After a predefined period of time, the energy is released by another pair / group of active elements 13 (e.g., electrodes) and the initial active elements (e.g., electrodes) become inactive. This is in Fig. 6 is indicated by arrows. Switching between pairs / groups of active elements 13 (e.g., electrodes) can continue until a target temperature is reached in the entire treatment area or a predefined energy is delivered by all active elements 13 (e.g., electrodes). Scheme II in Fig. Figure 6 illustrates the switching of all active elements 13 (e.g., electrodes) within the pad 4 between the ON state, when active elements (e.g., electrodes) emit energy, and the OFF state, when they do not emit energy. The duration of the ON and OFF states may vary depending on predefined settings and / or information provided by sensors, e.g., thermal sensors. Scheme III in Fig. Figure 6 shows the sequential switching of individual active elements 13 (e.g., electrodes) within a pad 4. Each active element 13 (e.g., electrode) emits energy for predefined periods of time until a target temperature is reached in the entire treatment area or a predefined energy is emitted by all active elements 13 (e.g., electrodes). This sequential switching can be performed in a clockwise or counterclockwise sequence. Scheme IV in Fig. 6 illustrates a zigzag switching sequence during which preferably non-adjacent active elements 13 (e.g., electrodes) sequentially deliver energy until all active elements 13 (e.g., electrodes) within a pad 4 have been switched on. Each active element 13 (e.g., electrode) delivers energy for a predefined period of time until a target temperature is reached in the entire treatment area or a predefined energy is delivered by all active elements (e.g., electrodes).

[0246] The control unit (e.g., CPU) can be configured to control the stimulation device and deliver treatment through at least one treatment protocol for improving visual appearance. The treatment protocol is a set of parameters for the primary electromagnetic energy and the secondary energy that ensure the desired treatment effect. Each pad can be controlled by the control unit (e.g., CPU) to deliver the same or alternatively a different protocol. Paired areas or areas where a symmetrical effect is desired can be treated using the same treatment protocol. Each protocol can include one or more sections or steps.

[0247] As a non-limiting example, in the case of applying the high frequency energy through the active elements (e.g. electrodes) sequentially, as shown in Schemes III and IV in Fig. As shown in Figure 6, the time during which an active element (e.g., electrode) delivers radiofrequency energy to the patient's tissue can be in the range of 1 ms to 10 s, or in the range of 10 ms to 5 s, or in the range of 50 ms to 2 s, or in the range of 100 ms to 1500 ms. Two consecutive elements can be turned on and off in a successive or overlapping manner. Additionally, the delivery of radiofrequency energy by two consecutive active elements (e.g., electrodes) can be separated by the time with no or little radiofrequency stimulation, such that neither of the two consecutive active elements (e.g., electrodes) delivers radiofrequency energy that causes heating of the treatment tissue. The time with no or low high frequency stimulation can be in the range of 1 µs to 1000 ms or in the range of 500 µs to 500 ms or in the range of 1 ms to 300 ms or in the range of 10 ms to 250 ms.

[0248] In the case of treatment where more than one pad is used, the sequential switching of the active elements (e.g. electrodes) providing the high frequency treatment can be provided in each pad independently of the other pads or the active elements (e.g. electrodes) can deliver the energy sequentially through all pads.

[0249] As an example for three dependent pads, each with two active elements (e.g. electrodes), the following applies: first step - the high-frequency energy can be provided by the active element one in the first pad, with the other active elements switched off, second step - the active element two of the first pad is switched on and the remaining active elements are switched off, third step - the active element one of the second pad is switched on and the remaining active elements are switched off, fourth step - the active element two of the second pad is switched on and the remaining active elements are switched off, fifth step - the active element one of the third pad is switched on and the remaining active elements are switched off, sixth step - the active element two of the third pad is turned on and the remaining active elements are turned off.

[0250] Another non-limiting example may be as follows: First step - the high frequency energy can be provided by the active element one in the first pad, with the other active elements switched off, second step - the active element one of the second pad is switched on and the remaining active elements are switched off, third step - the active element one of the third pad is switched on and the remaining active elements are switched off, fourth step - the active element two of the first pad is switched on and the remaining active elements are switched off, fifth step - the active element two of the second pad is switched on and the remaining active elements are switched off, sixth step - the active element two of the third pad is turned on and the remaining active elements are turned off.

[0251] In the case that the pads treat paired areas (e.g. cheeks, thighs or buttocks) where a symmetrical effect is desired, the paired pads can be operated simultaneously with the same protocol.

[0252] An example of a treatment protocol for a pad that delivers the radiofrequency energy for warming the patient and the electrical current that induces muscle contractions is as follows. The protocol may include a first section in which the electrodes in a pad can be treated so that the electrodes deliver pulses of electrical current whose envelopes are modulated with increasing amplitude modulation (increasing envelope), followed by constant amplitude (rectangular envelope), followed by decreasing amplitude modulation (decreasing envelope). All three envelopes together can produce a trapezoidal amplitude modulation (trapezoidal envelope). The trapezoidal envelope can last from 1 to 10 seconds, or 1.5 to 7 seconds, or 2 to 5 seconds. The increasing, rectangular, or decreasing envelope can last from 0.1 to 5 seconds, or 0.1 to 4 seconds, or 0.1 to 3 seconds.The increasing and decreasing envelopes can last the same time, creating a symmetrical trapezoidal envelope. Alternatively, the electrical current can be modulated into a sinusoidal, rectangular, or triangular envelope. The respective envelopes that induce muscle contractions can be separated by a period of no or low current stimulation, so that no muscle contraction is achieved, or by radiofrequency energy, which induces tissue heating. During the period without muscle contraction, pressure massage can be provided through suction ports, which can induce muscle relaxation.The first section can be preprogrammed so that electrodes at different locations on the pad can be switched in time to deliver alternating current pulses, while some other electrodes in the pad cannot deliver alternating current pulses, but only RF pulses that induce tissue heating. All electrodes in the pad can ensure the delivery of RF pulses for tissue heating during the protocol section or protocol (can be switched by circuit 14, controlled by control unit 11, to deliver these), while only a limited number of the electrodes can deliver alternating currents for muscle contraction during the protocol section or protocol (can be switched by circuit 14 to deliver these). The device can be configured so that the first section lasts 1-5 minutes.

[0253] The first section may be followed by a second section. The second section may be preprogrammed so that electrodes other than those used in the first section can be switched at different locations on the pad in time to deliver alternating current pulses. Some other electrodes (the same or different electrodes than those used in the first section) in the pad cannot deliver alternating current pulses, but only RF pulses, which induce tissue heating.

[0254] The second section may be followed by a third section. The third section may be preprogrammed so that electrodes other than those used in the second section can be switched at different locations on the pad in time to deliver alternating current pulses. Some other electrodes (the same or different electrodes than those used in the second section) in the pad cannot deliver alternating current pulses, but only RF pulses, which induce tissue heating.

[0255] An example treatment protocol for three dependent pads, e.g., one pad for treating the forehead (forehead pad) and two pads for treating the left and right cheeks (left and right cheek pads), which deliver radiofrequency energy to heat the patient and electrical current to induce muscle contractions, is as follows: The first pad, e.g., for treating the forehead, may have six active elements, e.g., electrodes E1-E6; the second pad, e.g., for treating the left cheek, may have seven active elements, e.g., electrodes E7-E13; and the third pad, e.g., for treating the right cheek, may have seven active elements, e.g., electrodes E14-E20. Some electrodes may be configured to deliver radiofrequency energy, and some electrodes may be configured to deliver both radiofrequency energy and electrical current.

[0256] The radio frequency energy may be monopolar radio frequency energy with a frequency in the range of 100 kHz to 550 MHz, or in the range of 250 kHz to 500 MHz, or in the range of 350 kHz to 100 MHz, or in the range of 350 kHz to 14 MHz. The radio frequency energy may be delivered with a rectangular envelope lasting from 200 to 3000 ms, or from 250 to 2000 ms, or from 300 to 1800 ms, or from 350 to 1500 ms. Alternatively, the radio frequency envelope (hereinafter referred to as the RF envelope) may be modulated into a sinusoidal envelope, a triangular envelope, or a trapezoidal envelope.

[0257] The electric current can be a bipolar (biphasic) rectangular AC-TENS current with a frequency in the range of 10 Hz to 10 kHz, or in the range of 25 Hz to 1 kHz, or in the range of 50 to 500 Hz, or in the range of 100 to 300 Hz, modulated to a trapezoidal envelope that can last from 1 to 10 seconds, or 1.5 to 7 seconds, or 2 to 5 seconds. An increasing, rectangular, or decreasing envelope of the trapezoidal envelope can last from 0.1 to 5 seconds, or 0.1 to 4 seconds, or 0.1 to 3 seconds. The increasing and decreasing envelopes can have the same duration, thus producing a symmetrical trapezoidal envelope. Alternatively, the envelope of the electric current (hereinafter EC envelope) can be modulated to a sinusoidal envelope, a rectangular envelope, or a triangular envelope.

[0258] The protocol may have a cycle that includes sections. The number of protocol sections in a cycle may be the same as or different from the total number of electrodes used in all pads used for treatment. The number of sections per pad can range from 1 to 100, or from 1 to 80, or from 1 to 60, or from 2 to 20, or from 3 to 10, or from 4 to 9. The number of sections per cycle can range from 1 to 100, or from 1 to 80, or from 1 to 60, or from 2 to 40, or from 3 to 35, or from 4 to 30. Each protocol section can follow the previous protocol section, e.g., the second section follows the first section. Each protocol section can last for 200 to 3000 ms, or for 250 to 2000 ms, or for 300 to 1800 ms, or for 350 to 1500 ms. The cycle can be repeated 30 to 300, or 50 to 250, or 80 to 220, or 100 to 200 times per treatment.Alternatively, the cycle may be repeated 150 to 600, or 190 to 550, or 200 to 520, or 210 to 500 times per treatment. In one aspect, the treatment protocol may repeat the same cycle. In another aspect, the treatment protocol may repeat different cycles, where the cycles may differ in the number of sections and / or in the duration of the sections and / or in the sequence of activation and / or deactivation of the electrodes and / or in the parameters specified for the RF and / or EC envelopes (e.g., envelope shape, amplitude, frequency, duration, etc.) and / or in the parameters specified for the radiofrequency and / or in the parameters of the electrical current.

[0259] An example of a cycle containing 20 sections might be as follows:

[0260] In the first section, the electrode E2 emits the RF envelope.

[0261] In the second section, electrode E7 emits the RF envelope.

[0262] In the third section, electrode E14 emits the RF envelope.

[0263] In the fourth section, electrode E5 emits the RF envelope.

[0264] In the fifth section, electrode E8 emits the RF envelope.

[0265] During the first to fifth sections, the electrode pairs E1-E4, E3-E6, E9-E10, E11-E12, E16-E17, and the electrode pair E18-E19 emit the EC envelope, which induces muscle contractions under the first, second, and third pads, e.g., under the forehead pad, the left cheek pad, and the right cheek pad.

[0266] In the sixth section, electrode E15 emits the RF envelope.

[0267] In the seventh section, electrode E13 emits the RF envelope.

[0268] In the eighth section, the electrode E20 emits the RF envelope.

[0269] In the ninth section, the electrode E1 emits the RF envelope.

[0270] In the tenth section, electrode E3 emits the RF envelope.

[0271] During the sixth to tenth sections, the electrode pairs E9-E10, E11-E12, E16-E17, and the electrode pair E18-E19 emit the EC envelope, which induces muscle contractions under the second and third pads, e.g., under the left and right cheek pads.

[0272] In the eleventh section, electrode E6 emits the RF envelope.

[0273] In the twelfth section, electrode E4 emits the RF envelope.

[0274] In the thirteenth section, electrode E9 emits the RF envelope.

[0275] In the fourteenth section, the electrode E16 emits the RF envelope.

[0276] In the fifteenth section, the electrode E12 emits the RF envelope.

[0277] During the eleventh to fifteenth sections, no electrode pairs emit the EC envelope, causing the muscles to relax.

[0278] In the sixteenth section, electrode E19 emits the RF envelope.

[0279] In the seventeenth section, the electrode E10 emits the RF envelope.

[0280] In the eighteenth section, electrode E17 emits the RF envelope.

[0281] In the nineteenth section, electrode E11 emits the RF envelope.

[0282] In the twentieth section, electrode E18 emits the RF envelope.

[0283] During the sixteenth to twentieth sections, the electrode pairs E1-E4 and E3-E6 emit the EC envelope, which induces muscle contractions under the first pad, e.g., under the forehead pad.

[0284] Another example of a treatment protocol for three dependent pads 4 controlled by the control unit 11, e.g., one pad for treating the forehead (forehead pad) and two pads for treating the left and right cheeks (left and right cheek pads), which emit radiofrequency energy to heat the patient and electrical current to induce muscle contractions, is as follows: The first pad, e.g., for treating the forehead, may have six active elements, e.g., electrodes E1-E6; the second pad, e.g., for treating the left cheek, may include six active elements, e.g., electrodes E7-E12; and the third pad, e.g., for treating the right cheek, may include six active elements, e.g., electrodes E13-E18. Some active elements may be configured to emit either electromagnetic energy (e.g., radiofrequency energy) or secondary energy (e.g.,electrical current), and some active elements may be configured to provide both electromagnetic energy and secondary energy. Alternatively, each active element may be part of a pad 4 (so that eighteen pads are used instead of three), or it may be possible to use only the active elements (e.g., electrodes without the pad substrate) attached to the treated areas. Each protocol section may last for 200 to 3000 ms, or for 250 to 2000 ms, or for 300 to 1800 ms, or for 350 to 1500 ms. The cycle may be repeated 30 to 300, or 50 to 250, or 80 to 220, or 100 to 200 times per treatment / treatment protocol. Alternatively, the cycle may be repeated 150 to 600, 190 to 550, 200 to 520, or 210 to 500 times per treatment. In one aspect, the treatment protocol may repeat the same cycle.In another aspect, the treatment protocol may repeat different cycles, wherein the cycles may differ in the number of sections and / or in the duration of the sections and / or in the sequence of activation and / or deactivation of the active elements and / or in the parameters established for the electromagnetic energy and / or the secondary energy (e.g., envelope shape, amplitude, frequency, duration, etc.).

[0285] A cycle of the exemplary treatment protocol executed by the control unit 11 may include one or more sections from the following list:

[0286] In one section, the electrode E10 emits the RF envelope.

[0287] In another section, electrode E18 emits the RF envelope.

[0288] In another section, electrode E11 emits the RF envelope.

[0289] In another section, electrode E15 emits the RF envelope.

[0290] In another section, electrode E12 emits the RF envelope.

[0291] In another section, the electrode E1 emits the RF envelope.

[0292] In another section, electrode E14 emits the RF envelope.

[0293] In another section, electrode E7 emits the RF envelope.

[0294] In another section, electrode E13 emits the RF envelope.

[0295] In another section, electrode E8 emits the RF envelope.

[0296] In another section, electrode E4 emits the RF envelope.

[0297] In another section, electrode E3 emits the RF envelope.

[0298] In another section, no electrode emits the RF envelope.

[0299] In another section, electrode E6 emits the RF envelope.

[0300] In another section, electrode E5 emits the RF envelope.

[0301] In another section, electrode E16 emits the RF envelope.

[0302] In another section, electrode E9 emits the RF envelope.

[0303] In another section, electrode E17 emits the RF envelope.

[0304] In another section, electrode E2 emits the RF envelope.

[0305] The sections may be arranged sequentially in a specific order, with each section being included one or more times in the cycle. In one aspect, some sections may not be included in the cycle (e.g., a section in which no electrode delivers the RF envelope). Each protocol section may last for 200 to 3000 ms, or for 250 to 2000 ms, or for 300 to 1800 ms, or for 350 to 1500 ms, and some sections of the cycle may last for time t1, some sections may last for time t2, where t2 is longer than t1. Additionally, some sections may last for time t3, which is longer than both t1 and t2. For example, the sections may be arranged so that the electrode following the previous electrode originates from a different pad than the previous electrode.

[0306] The cycle may further comprise delivering electrical current (e.g., one or more EC envelopes) through the electrode pairs of the first pad (e.g., E3-E5 and E4-E6) for a period of one or more sections in a row, e.g., one to seven sections, two to six sections, three to five sections, or four to five sections in a row, thereby inducing muscle contractions beneath the first pads, e.g., beneath the forehead pad. Therefore, the electrical current may be delivered by the electrode pairs of the first pad (e.g., E3-E5 and E4-E6) for a period of 200 ms to 21 s, 250 ms to 12 s, 900 ms to 9 s, or 1.4 s to 7.5 s.

[0307] The cycle may further comprise delivering electrical current (e.g., one or more EC envelopes) through the electrode pairs of the first, second, and third pads (e.g., E3-E5, E4-E6, E9-E11, E10-E12, E15-E17, and E16-E18) for a period of time of one or more sections in a row, e.g., one to seven sections, two to six sections, three to five sections, or four to five sections in a row, thereby inducing muscle contractions under the first, second, and third pads, e.g., under the forehead pad and the left and right cheek pads. Therefore, the electric current can be delivered from the electrode pairs of the first, second and third pads (e.g., E3-E5, E4-E6, E9-E11, E10-E12, E15-E17 and E16-E18) for a time period of 200 ms to 21 s, 250 ms to 12 s, 900 ms to 9 s, 1.4 s to 7.5 s.

[0308] The cycle may further comprise delivering electrical current (e.g., one or more EC envelopes) through the electrode pairs of the second and third pads (e.g., E9-E11, E10-E12, E15-E17, and E16-E18) for a period of one or more sections in a row, e.g., one to seven sections, two to six sections, three to five sections, or four to five sections in a row, thereby inducing muscle contractions under the second and third pads, e.g., under the left and right cheek pads. Therefore, the electric current can be delivered from the electrode pairs of the second and third pads (e.g., E9-E11, E10-E12, E15-E17, and E16-E18) for a duration of 200 ms to 21 s, 250 ms to 12 s, 900 ms to 9 s, and 1.4 s to 7.5 s.

[0309] During some sections of the cycle, no electrode pairs emit the EC envelope, causing the muscles to relax.

[0310] The treatment protocol can be preprogrammed so that each electrode used during treatment can deliver the RF envelope once per cycle, and some electrode pairs (e.g., E1-E4) can deliver the EC envelope twice per cycle. Alternatively, each electrode can deliver the RF envelope 2 to 10, 2 to 8, or 2 to 5 times per cycle; and some electrode pairs can deliver the EC envelope 1 to 10, 1 to 8, or 1 to 5 times per cycle.

[0311] In one aspect, the treatment protocol may be preprogrammed so that only one electrode delivers the RF envelope per section. In another aspect, 2 to 20, or 2 to 15, or 2 to 10, or 2 to 5, or 2 to 3 electrodes deliver RF envelopes in each section simultaneously, where the RF envelopes may be the same or different, and where the electrodes delivering RF envelopes may originate from different pads. In another aspect, no RF envelopes may be delivered during at least one section.

[0312] The treatment protocol can be preprogrammed so that during a single treatment, RF envelopes are delivered 25 to 300, 50 to 250, 80 to 200, or 100 to 180 times from each electrode, with an RF pause time between each RF envelope delivery. The RF pause time—the time during which the electrode does not deliver radiofrequency energy to the patient between two consecutive RF envelope deliveries—can range from 0.5 to 20 s, or from 1 to 15 s, or from 1.5 to 12 s, or from 2 to 10 s.

[0313] In one aspect, the radiofrequency energy can be controlled by a control unit (e.g., CPU) to provide a constant heating radiofrequency power (CHRP) to each electrode, meaning that each electrode provides homogeneous heating of the patient. A CHRP setting can be preprogrammed in the treatment protocol for each specific electrode in each specific pad based on the dimensions of the electrode and / or its position within the pad and / or its position on the patient's body area.In another aspect, the radiofrequency power can be controlled by the control unit based on feedback from at least one thermal sensor measuring the temperature of the treated body area and / or the temperature of the electrode delivering the radiofrequency energy, such that when the desired temperature is reached, the electrodes are controlled to maintain the temperature at that desired level. A typical treatment temperature of the body area beneath the electrode is in the range of 37.5°C to 55°C, or in the range of 38°C to 53°C, or in the range of 39°C to 52°C, or in the range of 40°C to 50°C, or in the range of 41°C to 45°C.

[0314] The treatment protocol can be preprogrammed so that during a single treatment, the EC envelopes are delivered 25 to 1000, or 50 to 900, or 100 to 750, or 120 to 600, or 150 to 500 times by at least one electrode pair, with an EC pause time between each EC envelope delivery. The EC pause time—the time during which the electrode pair does not deliver electrical current to the patient between two consecutive EC envelope deliveries—can range from 0.5 to 20 s, or from 1 to 15 s, or from 1.5 to 12 s, or from 2 to 10 s. Alternatively, the electrode pair can deliver one EC envelope after another without the EC pause time.

[0315] The treatment protocol may be preprogrammed so that the active element 13 (e.g. electrode) provides 1 to 900 electrical pulses, 2 to 700 electrical pulses, 10 to 500 electrical pulses, 25 to 400 electrical pulses, 50 to 375 electrical pulses or 100 to 200 electrical pulses during at least one section.

[0316] In another aspect, the radiofrequency energy can be delivered constantly through all electrodes throughout the treatment and only the EC envelopes can be delivered sequentially.

[0317] Another non-limiting example of a cycle of the treatment protocol executed by the control unit 11 for three pads 4 providing muscle contractions may be as follows:

[0318] The cycle may involve delivering electrical current (e.g., one or more EC envelopes) through the electrode pairs of the first pad (e.g., E3-E5 and E4-E6) for a duration of one or more sections in a row, e.g., one to seven sections, two to six sections, three to five sections, or four to five sections in a row, thereby inducing muscle contractions beneath the first pads, e.g., beneath the forehead pad. Therefore, the electrical current may be delivered by the electrode pairs of the first pad (e.g., E3-E5 and E4-E6) for a duration of 200 ms to 21 s, 250 ms to 12 s, 900 ms to 9 s, or 1.4 s to 7.5 s.

[0319] The cycle may further comprise delivering electrical current (e.g., one or more EC envelopes) through the electrode pairs of the first, second, and third pads (e.g., E3-E5, E4-E6, E9-E11, E10-E12, E15-E17, and E16-E18) for a period of time of one or more sections in a row, e.g., one to seven sections, two to six sections, three to five sections, or four to five sections in a row, thereby inducing muscle contractions under the first, second, and third pads, e.g., under the forehead pad and the left and right cheek pads. Therefore, the electric current can be delivered from the electrode pairs of the first, second and third pads (e.g., E3-E5, E4-E6, E9-E11, E10-E12, E15-E17 and E16-E18) for a time period of 200 ms to 21 s, 250 ms to 12 s, 900 ms to 9 s, 1.4 s to 7.5 s.

[0320] The cycle may further comprise delivering electrical current (e.g., one or more EC envelopes) through the electrode pairs of the second and third pads (e.g., E9-E11, E10-E12, E15-E17, and E16-E18) for a period of one or more sections in a row, e.g., one to seven sections, two to six sections, three to five sections, or four to five sections in a row, thereby inducing muscle contractions under the second and third pads, e.g., under the left and right cheek pads. Therefore, the electric current can be delivered from the electrode pairs of the second and third pads (e.g., E9-E11, E10-E12, E15-E17, and E16-E18) for a duration of 200 ms to 21 s, 250 ms to 12 s, 900 ms to 9 s, and 1.4 s to 7.5 s.

[0321] During some sections of the cycle, no electrode pairs emit the EC envelope, causing the muscles to relax.

[0322] In one aspect, the treatment protocol may be preprogrammed such that each active element 13 (e.g., electrode, coil, heating element, fluid conduit) used during treatment can provide heating once per cycle, and some active elements 13 (e.g., electrode, coil) can provide muscle contractions one or more times per cycle. Alternatively, each active element 13 can provide heating 2 to 10, 2 to 8, or 2 to 5 times per cycle, and some active elements 13 can provide muscle contractions 1 to 10, 1 to 8, or 1 to 5 times per cycle.

[0323] In one case, the treatment protocol may be preprogrammed so that only one active element 13 provides heating per section (e.g., using radiofrequency energy). In another aspect, 2 to 20, or 2 to 15, or 2 to 10, or 2 to 5, or 2 to 3 active elements 13 provide heating in each section simultaneously, where the heating temperature may be the same or different. In another aspect, heating may not be provided during at least one section. Each protocol section may last for 200 to 3000 ms, or for 250 to 2000 ms, or for 300 to 1800 ms, or for 350 to 1500 ms, and some sections of the cycle may last for time t1, some sections may last for time t2, where t2 is longer than t1. Additionally, some sections may last for time t3, which is longer than t1 and t2.

[0324] In one aspect, the treatment protocol may be preprogrammed such that, during a single treatment, heating (e.g., by radiofrequency energy) is provided 25 to 300, or 50 to 250, or 80 to 200, or 100 to 180 times by one or more active elements 13, with a pause time between each heating. The heating pause time—the time during which no active element 13 provides heating to the patient between two consecutive heating sessions—may range from 20 ms to 10 s, or from 50 ms to 5 s, or from 100 ms to 2 s, or from 250 ms to 1 s.

[0325] In one aspect, the active elements 13 can be controlled by a control unit (e.g., CPU) to maintain the temperature at a desired level. A typical treatment temperature of the body area under the active elements 13 is in the range of 37.5°C to 55°C, or in the range of 38°C to 53°C, or in the range of 39°C to 52°C, or in the range of 40°C to 50°C, or in the range of 41°C to 45°C.

[0326] The treatment protocol can be preprogrammed so that during a single treatment, muscle contractions are provided 25 to 1000, or 50 to 900, or 100 to 750, or 120 to 600, or 150 to 500 times by at least one active element 13 (e.g., by providing the electrical current) or at least one pair of active elements 13 with a contraction pause time between muscle contractions. A contraction can have a duration in the range of 0.1 to 15 seconds, or in the range of 0.5 to 12 seconds, or in the range of 1 to 10 seconds, or in the range of 2 to 8 seconds. The contraction pause time - the time during which the at least one active element 13 or the at least one pair of active elements 13 does not provide muscle contraction between two consecutive contractions - may range from 0.5 to 20 s or from 1 to 15 s or from 1.5 to 12 s or from 2 to 10 s.Alternatively, the at least one active element 13 or the at least one pair of active elements 13 may provide one contraction after another without the contraction pause time.

[0327] The treatment protocol may be preprogrammed so that the active element 13 (e.g., electrode or coil) delivers 1 to 900 pulses of secondary energy, or 2 to 700 pulses of secondary energy, or 10 to 500 pulses of secondary energy, or 25 to 400 pulses of secondary energy, or 50 to 375 pulses of secondary energy, or 100 to 200 pulses of secondary energy during at least one section. Furthermore, the treatment protocol may be preprogrammed so that the active element 13 (e.g., electrode or coil) delivers envelopes of secondary energy 25 to 1,000, or 50 to 900, or 100 to 750, or 120 to 600, or 150 to 500 times during the treatment.

[0328] In another aspect, the heating may be provided constantly by all active elements 13 throughout the treatment and only the contractions may be provided sequentially, for example with a contraction pause time between each muscle contraction.

[0329] In yet another aspect, the treatment or cycle may include at least one section in which no energy / signal is provided to the tissue.

[0330] In one aspect, the pad may include one or more active elements 13 (e.g., electrode or coil) that provide more than one energy, or the pad may include multiple different active elements 13 (e.g., electrode and coil) that provide more than one energy. For example, radiofrequency energy, electric current, and magnetic field, or radiofrequency energy, electric current, and ultrasound. Alternatively, the pad may be configured to produce more than two therapies, for example, heating of the skin (e.g., via radiofrequency energy), contraction of muscles (e.g., via electric current), and massage / relaxation of tissue (e.g., via pressure pulses).

[0331] A single treatment can last from 1 to 60 minutes, or 5 to 45 minutes, or 10 to 30 minutes, or 15 to 25 minutes, or 18 to 23 minutes, depending on the number of pads used during the treatment. The number of pads used in a single treatment

[0332] Pads can be 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or up to 100. The protocol can be preprogrammed so that the electrodes that provide the electrical current that causes muscle contractions are switched to providing radiofrequency heating after they produce a maximum of one, two, three, four, or five contractions.

[0333] The respective sections are compiled by the control unit (CPU) in the treatment protocol in such a way that at least 60-900 contractions or 90800 contractions or 150-700 contractions are provided by a single pad per treatment.

[0334] In addition, the respective electrode pairs that provide electrical current to the patient are controlled by the control unit (CPU) to provide at least 501000 contractions or 60-900 contractions or 90-800 contractions or 100450 contractions per treatment.

[0335] The forehead pad may include a layout of electrodes such that the anatomical area 1 and the anatomical area 2 are stimulated by alternating currents that can induce muscle contractions, while the anatomical area 3 is not stimulated by alternating currents that induce muscle contractions, as in Fig. 10. The control unit (CPU) is configured to provide a treatment protocol in which only the electrodes located near or above the anatomical region 1 and 2 are excited with alternating electrical currents; and in which only the electrode(s) near or above the anatomical region 3 are excited with radiofrequency energy, as shown in Fig. 10. Anatomical areas 1 and 2 may include the frontalis muscle, and anatomical area 3 may include the center of the procerus muscle. The forehead pad may also treat the corrugator supercilii or orbicularis oculi muscles with radiofrequency energy.

[0336] The pad used for treating the cheek (on both sides of the face below the eye) can incorporate a layout of electrodes so that the anatomical area including the buccinator, masseter, zygomatic, or risorius muscles is stimulated with electrical currents that can induce muscle contractions, while the other anatomical area can only be heated by the radiofrequency energy. A cheek pad can also be used to contract the levator labii superioris muscle.

[0337] In contrast, the pad may be configured so that the layout of the electrodes near the eyes (e.g., body part that includes the orbicularis oculi muscle) or the teeth (e.g., body part that includes the orbicularis oris muscle) cannot provide energy that causes muscle contractions.

[0338] The pad used for treating the submentum or submental area may include a layout of electrodes such that the anatomical area including the mylohyoid muscle or the digastric muscle is stimulated with electrical current, which may induce muscle contractions, while the other anatomical area may only be heated by the radiofrequency energy. In one aspect, a submental pad (a pad used to treat the submentum) may not deliver electrical current to the Adam's apple, but may instead deliver heating to the Adam's apple using radiofrequency energy.

[0339] The treatment device can be configured so that the impedance sensor in each section or step provides information about the contact of the pad or active element (e.g., electrode) with the patient to the control unit (e.g., CPU). The impedance can be measured by the active element (e.g., electrode) itself. The control unit (e.g., CPU) can determine, based on preset conditions, whether the contact of the pad or active element (e.g., electrode) with the patient is sufficient or insufficient. In case of sufficient contact, the control unit (e.g., CPU) can allow the treatment protocol to continue. In case of inappropriate contact, the evaluated pad or active element (e.g., electrode) is deactivated, and the treatment protocol proceeds to the subsequent pad or active element (e.g., electrode), or the treatment is terminated.The determination of the correct contact of the pad or the active element (e.g. electrode) can be displayed on the human-machine interface 8.

[0340] The impedance measurement can be taken at the beginning of the section / step, during the section / step, or at the end of the section / step. The impedance measurement and / or the assessment of correct contact can be determined only at the active electrodes for the given section / step or can be taken at all electrodes of all pads used during the section / step.

[0341] In one aspect, the impedance through all active elements (e.g., electrodes) can be monitored while therapy is being delivered to the patient. The device monitors the impedance between the active element (e.g., electrode) and the patient's skin while delivering treatment energy (e.g., radiofrequency or electrical current) to the patient, analyzes the monitored impedance at two or more different times to determine a change in the size of the electrode-skin contact area, and changes the stimulation delivered to the patient or terminates treatment when the change in monitored impedance reaches a predetermined threshold.The change in the impedance value at a given time point can be quantified by an impedance ratio between the impedance value at that time point and a baseline impedance, which is a first impedance value from the history of the impedance measurement of a given active element (e.g., electrode).

[0342] The device may further comprise a billing system. The billing system may be based on a reader and an information medium (e.g., a card) on which the number of therapies is recorded. The information medium (e.g., card) may be inserted into the reader or function contactlessly, and then the amount of the recorded number of therapies is deducted based on the number of pads used during therapy. A new information medium (e.g., card) may contain a recorded number of therapies in a range from 1 to 100, or in a range from 2 to 80, or in a range from 5 to 50, or in a range from 10 to 40. If the information medium (e.g., card) no longer contains the recorded number of therapies, the user can order a new information medium (e.g., card). If disposable pads or applicators are involved, the information medium can be part of the order for new pads or applicators, and the recorded number of therapies can correspond to the number of pads or applicators ordered. For example, if the device user orders 30 disposable pads, the number of recorded therapies on the information medium (e.g., the card, which is also part of the order) will also be 30. The reader can be part of the main unit 2, the connection block 3, or the applicator.

[0343] Fig. 7 and Fig. 8 are discussed together. Fig. 7 shows a block diagram of a contactless therapy device 100. Fig.8 is an illustration of a contactless therapy device 100. The contactless therapy device 100 may comprise two main blocks: the main unit 2 and a delivery head 19, which are connected to each other via a fixed or adjustable arm 21.

[0344] The main unit 2 may include a primary electromagnetic generator 6 capable of generating one or more forms of electromagnetic radiation. The electromagnetic radiation may be, for example, in the form of incoherent light or in the form of coherent light (e.g., laser light) of a predetermined wavelength. The electromagnetic field may be primarily generated by a laser, a laser diode module, an LED, a flash lamp, or a filament lamp. The electromagnetic radiation may be such that it can be at least partially absorbed below the surface of the patient's skin.The wavelength of the applied radiation may be in the range of 100 to 15,000 nm, or in the range of 200 to 12,000 nm, or in the range of 300 to 11,000 nm, or in the range of 400 to 10,600 nm, or it may be in the form of second, third, fourth, fifth, sixth, seventh, or eighth harmonic wavelengths of the aforementioned wavelength ranges. The main unit 2 may further include a human-machine interface 8 represented by a display, buttons, a keyboard, a touchpad, a touch panel, or other controls that allow an operator to review and adjust therapy and other device parameters. The power supply 5, located in the main unit, may include a transformer, a disposable battery, a rechargeable battery, a power plug, or a standard power cord.The output power of the power supply 5 can be in the range of 10 W to 600 W, or in the range of 50 W to 500 W, or in the range of 80 W to 450 W. The indicators 17 can provide additional information about the current status of the device independently of the human-machine interface 8. The indicators 17 can be implemented by display, LEDs, sound signals, vibrations, or other forms of appropriate notification.

[0345] The delivery head 19 may be connected to the main unit via an arm 21, which may form the main optical and electrical path. The arm 21 may comprise transmission media, e.g., wires or waveguides, e.g., mirrors or fiber optic cables, for electromagnetic radiation in the form of light or additional electrical signals required to supply power to the delivery head 19. The control unit (e.g., CPU) 11 controls the primary electromagnetic generator 6, which generates continuous electromagnetic energy (CM) or a pulse with a fluence in the range of 0.1 pJ / cm 2 up to 1000 J / cm 2 or in the range of 0.5 pJ / cm 2 up to 800 J / cm 2 or in the range of 0.8 pJ / cm 2 up to 700 J / cm 2 or in the range of 1 pJ / cm 2 up to 600 J / cm 2at the output of the electromagnetic generator. The CM mode can be operated for a time interval in the range of 0.1 s to 24 hours, or in the range of 0.2 s to 12 hours, or in the range of 0.5 s to 6 hours, or in the range of 1 s to 3 hours. The pulse duration of the electromagnetic radiation operated in the pulse scheme can be in the range of 0.1 fs to 2000 ms, or in the range of 0.5 fs to 1500 ms, or in the range of 1 fs to 1200 ms, or in the range of 1 fs to 1000 ms. Alternatively, the pulse duration can 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.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 primary electromagnetic generator 6 in the pulse pattern may be operated by a control unit 11 (e.g., CPU) in a single-shot mode, a repeat mode, or a burst mode. The frequency of the repeat mode or burst mode may be in the range of 0.05 to 10,000 Hz, or in the range of 0.1 to 5,000 Hz, or in the range of 0.3 to 2,000 Hz, or in the range of 0.5 to 1,000 Hz. Alternatively, the frequency of the repeat mode or the burst mode can be in the range of 0.1 kHz to 200 MHz, or in the range of 0.5 kHz to 150 MHz, or in the range of 0.8 kHz to 100 MHz, or in the range of 1 kHz to 80 MHz. The single-shot mode can be configured to deliver a single burst of electromagnetic energy with specific parameters (e.g., intensity, duration, etc.).) for irradiating a single treatment area. The repetition mode may be configured to generate electromagnetic energy, which may have one or more specific parameters (e.g., intensity, duration, etc.), at a repetition rate of the aforementioned frequency for irradiating a single treatment area. The burst mode may be configured to generate, during a sequence, multiple consecutive electromagnetic energies, which may have variable parameters (e.g., intensity, duration, delay, etc.), wherein the sequences are repeated at the aforementioned frequency and wherein the sequence may include the same or different sets of consecutive electromagnetic energies.

[0346] Alternatively, the device may include more than one primary electromagnetic generator 6 for generating the same or a different electromagnetic energy, e.g., one primary electromagnetic generator is used to generate an ablative electromagnetic energy and the other is used to generate a non-ablative electromagnetic energy. In this case, it is possible for an operator to select which primary electromagnetic generators can be used for a given treatment, or the physician can select a required treatment through the human-machine interface 8, and the control unit (e.g., CPU) 11 selects which primary electromagnetic generators are used. It is possible to operate one or more primary electromagnetic generators of the device 100 simultaneously, successively, or in an overlapping mode. For example, in the case of two primary electromagnetic generators: In the simultaneous mode, both primary electromagnetic generators are used simultaneously during a time interval of, for example, 1-20 ps. In the successive mode, the first primary electromagnetic generator is used during the first time interval of, for example, 1 to 10 ps.The first primary electromagnetic generator is then stopped, and the second primary electromagnetic generator is immediately used in a subsequent time interval of, for example, 10 to 20 ps. Such a sequence of two or more successive steps can be repeated. In the overlapping process, the first primary electromagnetic generator is used during one time interval, for example, 1-10 ps, ​​and the second primary electromagnetic generator is used in a second overlapping time interval, for example, 2-11 ps. During the second time interval, the first primary electromagnetic generator and the second primary electromagnetic generator overlap, for example, with a total time for the overlapping process of 2-10 ps.In the case of more than two primary electromagnetic generators, the activation and deactivation of the primary electromagnetic generators can be controlled in a successive or overlapping process by the control unit (e.g., CPU) 11 in the order appropriate for a given treatment, e.g., first activating the primary electromagnetic generator for preheating, then the primary electromagnetic generator for ablation, and then the non-ablative primary electromagnetic generator.

[0347] The active elements 13 in the delivery head 19 can be in the form of optical elements, which can be represented by one or more optical windows, lenses, mirrors, fibers, or diffractive elements. The optical element representing the active element 13 can be connected to or contain the primary electromagnetic generator 6 within the delivery head 19. The optical element can generate a beam of electromagnetic energy that creates an energy spot with an energy spot size defined as a tissue surface irradiated by a light beam. An optical element can provide one or more energy spots, e.g., by splitting a beam into a plurality of beams. The energy spot size can be in the range of 0.001 cm 2 up to 1000 cm 2 or in the range of 0.005 cm 2 up to 700 cm 2 or in the range of 0.01 cm 2 up to 300 cm 2 or in the range of 0.03 cm2 up to 80 cm 2 Energy points of different or the same wavelength can be superimposed or separated. Two or more light beams can be applied to the same point simultaneously or at a time interval ranging from 0.1 µs to 30 seconds. The energy points can be separated by at least 1% of their diameter. In addition, the energy points can be closely spaced or separated by a distance ranging from 0.01 mm to 20 mm, or from 0.05 mm to 15 mm, or from 0.1 mm to 10 mm.

[0348] The control unit (e.g. CPU) can also be responsible for switching between the active elements 13 or for moving the active elements 13 within the delivery head 19 so that the electromagnetic radiation can be delivered homogeneously to the entire treatment area marked by the aiming beam 18. The rate of switching between the active elements 13 can depend on the amount of delivered energy, the pulse length, etc., and the speed of the control unit (e.g. CPU) or another

[0349] mechanism responsible for switching or moving the active elements 13 (e.g. scanner). In addition, a device can be configured to switch between multiple active elements 13 so that they release energy simultaneously, successively, or in an overlapping process. For example, in the case of two active elements: In the simultaneous process, both active elements are used simultaneously during the time interval, e.g. 1-20 ps. In the successive process, the first active element is used during the first time interval, e.g. 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, e.g. from 10 to 20 ps. This successive step can be repeated. In the overlapping process, the first active element is used during a time interval for e.g.1-10 ps and the second active element is used in a second overlapping time interval for, e.g., 2-11 ps, during which time the first active element and the second active element overlap, e.g., with a total time for the overlapping process of 2-10 ps.

[0350] The aiming beam 18 has no clinical effect on the treated tissue and can serve as a tool for marking the area to be treated, allowing the operator to know the exact area being irradiated, and the control unit 11 (e.g., CPU) can set and adjust the treatment parameters accordingly. A aiming beam can be generated by a separate electromagnetic generator or by the primary electromagnetic generator 6. The aiming beam 18 can emit energy with a wavelength in the range of 300-800 nm and can deliver energy with a maximum power of 10 mW.

[0351] Additionally, the pad may include a control unit 11 (e.g., CPU) that controls a distance sensor 22 for measuring a distance from the active element 13 to the treated point within the area marked by the aiming beam 18. The measured value may be used by the CPU 11 as a parameter to adjust one or more treatment parameters that may depend on the distance between the active element and a treatment point, e.g., the fluence. The information from the distance sensor 22 may be provided to the control unit 11 (e.g., CPU) before each switching / movement of an active element 13, so that the delivered energy remains consistent across the treated area, regardless of its shape or unevenness.

[0352] The patient's skin may be pre-cooled to a selected temperature for a selected duration over at least one treatment session, wherein the selected temperature and duration of pre-cooling are preferably sufficient to cool the skin to at least a selected temperature below normal body temperature. The skin may be cooled to at least the selected temperature to a depth below the at least one depth for the treatment sessions, such that the at least one treatment session is substantially surrounded by cooled skin. Cooling may continue during the irradiation application, wherein the duration of the irradiation application may be greater than the heat relaxation time of the treatment sessions. Cooling may be provided by any known mechanism, including water cooling, sprayed coolant, the presence of an active solid cooling element (e.g.,a Peltier cooler) or airflow cooling. A cooling element can serve as an optical element. Alternatively, a spacer can serve as the cooling element. Cooling can be provided during, before, or after treatment using electromagnetic energy. Pre-treatment cooling can also provide an environment for sudden heat shock, while post-treatment cooling can provide faster recovery from the heat shock. The temperature of the coolant can range from -200°C to 36°C. The temperature of the cooling element during treatment can range from -80°C to 36°C, or -70°C to 35°C, or -60°C to 34°C, or -20°C to 30°C, or 0°C to 27°C, or 5°C to 25°C. If the pad is not in contact with the patient's skin, cooling by cryospray, gas flow, or other non-contact cooling techniques can be used.A cooling gel on the skin surface may also be used, either in addition to or instead of one of the cooling techniques listed above.

[0353] In addition, the device 100 may include one or more sensors. The sensor may provide information about at least one physical quantity, and its measurement may result in feedback that may be displayed via the human-machine interface 8 or the indicators 17. The one or more sensors may be used to detect a variety of physical quantities, including, but not limited to, the energy of the emitted electromagnetic radiation or the electromagnetic radiation scattered back by the skin, the impedance of the skin, the resistance of the Skin, the temperature of the treated skin, the temperature of the untreated skin, the temperature of at least one skin layer, the water content of the device, the phase angle of the emitted or reflected energy, the position of the active elements 13, the position of the output element 19, the temperature of the cooling media, or the temperature of the primary electromagnetic generator 6. The sensor can be a temperature, sound, vibration, electrical, magnetic, flow, position, optical, imaging, pressure, force, energy flow, impedance, current, Hall, or proximity sensor. The sensor can be a capacitive displacement sensor, a sonic proximity sensor, a gyroscope, an accelerometer, a magnetometer, an infrared camera, or a thermal imaging camera. The sensor can be invasive or contactless. The sensor can be located on the output element 19 or in the main unit 2, or it can be part of a distance sensor 22.A sensor can measure more than one physical quantity. For example, a sensor can include a combination of a gyroscope, an accelerometer, or a magnetometer. In addition, the sensor can measure one or more physical quantities of the treated or untreated skin.

[0354] The thermal sensor measures and monitors the temperature of the treated skin. The temperature can be analyzed by a control unit 11 (e.g., CPU). The thermal sensor can be a non-contact sensor (e.g., an infrared temperature sensor). The control unit 11 (e.g., CPU) can also use algorithms to calculate a sub-skin temperature based on the skin's surface temperature and one or more additional parameters. A temperature feedback system can control the temperature and warn the operator based on set or preset limits in a human-perceptible form, e.g., on the human-machine interface 8 or via the indicators 17. In a limit temperature condition, the device can be configured to adjust the treatment parameters for each active element, e.g., the output power, activate cooling, or stop the treatment.A human-perceivable form may be a sound, a warning message displayed on the human-machine interface 8 or the indicators 17, or a color change of any part of the device 100.

[0355] A resistance sensor can measure skin resistance, as it can vary between patients, as can humidity—wetness and sweat can affect the resistance and thus the skin's behavior in the energy field. Based on the measured skin resistance, skin impedance can also be calculated.

[0356] The information from one or more sensors can be used to generate a path in a suitable model, e.g., a model of the human body, shown on a display of the human-machine interface 8. The path can illustrate a surface area or volume of previously treated tissue, currently treated tissue, tissue to be treated, or untreated tissue. A suitable model can show a temperature map of the treated tissue, providing information about the previously treated tissue or the untreated tissue.

[0357] The sensor can provide information about the location of bones, inflamed tissue, or joints. Electromagnetic radiation must not be directed at such tissue types, as treatment could be painful. Bones, joints, or inflamed tissue can be detected by any type of sensor, such as an imaging sensor (ultrasound sensor, IR sensor), impedance, and the like. The detected presence of these tissue types can trigger general human-detectable signals or a cessation of the generation of electromagnetic radiation. Bones can be detected, for example, by a change in the impedance of the tissue or by analyzing the reflected electromagnetic radiation.

[0358] The device 100 may further include an emergency stop button 16 so that the patient can immediately stop the therapy at any time during the treatment.

[0359] It may be part of the invention that the treatment method includes the following steps: preparing the tissue, positioning the proposed device, selecting or adjusting the treatment parameters, and applying the energy. More than one step can be performed simultaneously.

[0360] Tissue preparation may include removing makeup or cleansing the patient's skin. For higher target temperatures, anesthetics can be administered topically or by injection.

[0361] Positioning the device may involve selecting the correct pad shape according to the area to be treated and attaching the pad or neutral electrode to the patient, for example, using an adhesive layer, vacuum suction, a strap, or a mask. In the case of contact therapy, verifying correct contact with the treated tissue. In the case of non-contact therapy, positioning the device may involve adjusting the aiming beam of the proposed device so that the device can measure the distance of the active element(s) from the treatment area and adjust the treatment parameters accordingly.

[0362] Selecting or adjusting treatment parameters may include adjusting the treatment time, power, duty cycle, delivery time, and delivery mode (CM or pulsed), the surface density / size of the active points for the fractional array, and the operating mode. Selecting the operating mode may involve selecting a simultaneous, sequential, or overlapping procedure; selecting the switching order of the active elements or groups of active elements; or selecting the correct preprogrammed protocol.

[0363] The application of energy may involve providing at least one type of energy in the form of RF energy, electric current, ultrasonic energy, or electromagnetic energy in the form of polychromatic or monochromatic light, or a combination thereof. The energy may be delivered to the skin by at least one active element through the proposed device. The energy may be automatically delivered and regulated by the control unit (e.g., CPU) according to information from thermal sensors and impedance measurements and, in the case of contactless therapy, distance sensors. All automatic adjustments and possible effects on the therapy may be indicated on the device's display. Either the operator or the patient may interrupt the therapy at any time during the therapy. A typical treatment may last from approximately 1 to 60 minutes, or 2 to 50 minutes, or 3 to 40 minutes, or 5 to 30 minutes, or 8 to 25 minutes, or 10 to 20 minutes, depending on the treated area and the size and number of active elements contained in one or more pads. A typical treatment with 1, 2, 3, 4, 5, or up to 10 pads can have a total duration of approximately 1 to 60 minutes, or 2 to 50 minutes, or 3 to 40 minutes, 5 to 30 minutes, or 8 to 25 minutes, or 10 to 20 minutes. A typical treatment with one pad can have a total duration of approximately 1 to 30 minutes, or 2 to 25 minutes, or 3 to 22 minutes, 5 to 20 minutes, or 5 to 15 minutes, or 5 to 12 minutes.

[0364] In one example, applying energy to the tissue may involve delivering radiofrequency energy, electrical current, and / or ultrasonic energy, or any combination thereof, from the active elements embedded in the pad to the patient's skin. In such an embodiment, the active elements delivering radiofrequency energy are capacitive or resistive RF electrodes, and the RF energy may cause heating, coagulation, or ablation of the skin. The electrical current is delivered by the RF electrodes and may cause muscle contractions. The ultrasonic energy may be delivered through an acoustic window and increase the temperature at depth, thereby suppressing the gradient loss of the RF energy and thus allowing the desired temperature in the germinal layer to be achieved. Additionally, the RF electrode may serve as an acoustic window for ultrasonic energy.

[0365] Alternatively, the application of energy to the tissue may involve delivering electromagnetic energy in the form of polychromatic or monochromatic light from the active elements to the patient's skin. In such a case, the active elements delivering the electromagnetic energy may comprise the optical elements described in the proposed device. Optical elements may be represented by an optical window, a lens, a mirror, a fiber, or an electromagnetic field generator, e.g., an LED, laser, flash lamp, filament lamp, or other light sources known in the art. The electromagnetic energy in the form of polychromatic or monochromatic light may result in heating, coagulation, or ablation of the skin in the treated area.

[0366] After the required temperature and therapy time have been reached, the therapy is terminated, the device accessories can be removed and cleansing of the patient's skin can be provided.

[0367] Furthermore, the following aspect is considered as an additional part and as a further subject of the disclosure according to the present invention, individually or in combination with further features of the present invention: Device for treating a patient, comprising: a first generator configured to generate high frequency energy; a second generator configured to generate a pulsed electric current; an applicator comprising: a connector configured to connect the applicator to the first and second generators; and a pad having at least one active element attached to a treatment area and configured to deliver radio frequency energy from the first generator or the pulsed electrical current from the second generator to the treatment area; a control unit with one or more pre-programmed protocols; wherein the control unit is configured to control the first generator and the second generator; wherein the device is configured to deliver the radiofrequency energy and the pulsed electrical current to the treatment area according to the one or more preprogrammed protocols. QUOTES CONTAINED IN THE DESCRIPTION

[0000] This list of documents submitted by the applicant was generated automatically and is included solely for the convenience of the reader. This list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions. Cited patent literature

[0000] US 17 / 664,161

[0001] US 17 / 518,243

[0001] WO 2021 / 00300

[0001] US 63 / 019,619

[0001]

Claims

[1] Device for treating a patient, comprising: a first generator configured to generate high frequency energy; an applicator adapted to be attached to a body part of a patient, the applicator comprising: a connector configured to connect the applicator to the first generator; and a pad having at least one active element attachable to a treatment area of ​​the body part and configured to deliver the radiofrequency energy of the first generator to the treatment area; a control unit with one or more pre-programmed protocols; wherein the control unit is configured to control the first generator and deliver the radiofrequency energy to the treatment area according to the one or more preprogrammed protocols. [2] The device of claim 1, wherein the at least one active element comprises an electrode configured to apply the radiofrequency energy to cause heating of the treatment area; and wherein the body part comprises a face, a neck, or a submentum. [3] The apparatus of claim 2, wherein the first generator comprises a radio frequency generator configured to generate the radio frequency energy. [4] The apparatus of claim 3, wherein the control unit is configured to control the high frequency generator to generate the high frequency energy at a frequency in a range of 400 kHz to 80 MHz with an output power in a range of 1 W to 200 W. [5] Device according to one of claims 2 to 4, wherein the surface of the electrode is in a range of 1 cm 2 up to 25 cm 2 lies. [6] Device according to claim 5, wherein the surface of the electrode is in a range of 1 cm 2 up to 10 cm 2 lies. [7] Device according to claim 5 or 6, wherein the surface of the electrode is in a range of 2.5 cm 2 up to 9 cm 2 lies. [8] Device according to one of claims 2 to 5, wherein the electrode comprises: Grid lines that contain a conductive material; Passages that separate the grid lines; and a frame comprising the conductive material and defining an edge of the grid lines and the apertures. [9] The device according to claim 8, wherein the thickness of the frame is in a range of 0.1 mm to 5 mm. [10] Apparatus according to claim 8 or 9, wherein the thickness of the grid lines is in a range of 0.01 mm to 2.3 mm. [11] The device according to any one of claims 8 to 10, wherein the total projected area of ​​the frame, the grid lines inside the frame and the passages inside the frame is in a range of 1 cm 2 up to 20 cm 2 lies. [12] A device according to any one of claims 2 to 11, wherein the electrode comprises copper, aluminum, gold, lead, silver or graphite. [13] Device according to one of claims 2 to 12, wherein the distance between the nearest point of the at least one active element and the nearest point of an edge of the pad is in a range of 0.1 to 10 mm. [14] The device according to any one of claims 2 to 13, wherein the connector comprises a flexible circuit board. [15] The apparatus of claim 14, wherein the connector comprises a stiffener configured to stiffen the flexible circuit board against out-of-plane deformation. [16] Device according to one of claims 2 to 15, wherein the connector has 5 to 60 contacts. [17] The device of any one of claims 2 to 16, wherein the applicator further comprises a flexible connecting member connected to the pad on a first side and connected to the connector on a second side opposite the first side. [18] Device according to one of claims 2 to 17, wherein the surface of the pad is in a range of 0.5 cm 2 up to 100 cm 2 lies. [19] The device according to any one of claims 2 to 18, wherein the average thickness of the pad is in a range of 10 µm to 2000 µm. [20] Device according to one of claims 2 to 19, wherein the pad is flexible and designed such that it can be attached to the treatment area during the treatment, and wherein the pad further comprises a flexible substrate having a bottom surface configured to face the body part during treatment, and wherein the electrode is connected to the underside of the flexible substrate. [21] The device of claim 20, wherein the flexible substrate comprises a polymer-based material, a silicone-based material, or a fabric. [22] The device according to any one of claims 2 to 21, wherein the treatment area comprises one of the forehead, cheeks, periorbital area, jaw line, perioral area, neck or submentum. [23] The device of any one of claims 2 to 22, further comprising an adhesive disposed between the at least one active element and the body part and configured to secure the pad to the body part during treatment. [24] The device of claim 23, wherein the adhesive is part of the pad. [25] The device of claim 23 or 24, further comprising a protective film disposed beneath the adhesive, said protective film being adapted to be removed prior to treatment. [26] The device of any one of claims 2 to 25, wherein the applicator further comprises a sticker bonded to the top surface of the pad, the sticker overlapping the pad and having a dimension that exceeds a corresponding dimension of the pad in a range of 0.1 cm to 10 cm. [27] The device of claim 26, wherein an underside of the sticker has an adhesive layer configured to provide additional fixation of the pad to the patient's body part where the sticker overlaps the pad. [28] Device according to one of claims 2 to 27, further comprising a second generator adapted to generate a pulsed electrical current, wherein the second generator comprises a power generator, and wherein the control unit is designed to control the current generator such that it generates the pulsed electric current with a pulse duration in a range of 0.5 µs to 500 ms. [29] The device of claim 28, wherein the electrode is further configured to apply the pulsed electrical current to the treatment area to provide electrical stimulation. [30] The device of claim 28, wherein the at least one active element further comprises a second electrode configured to apply the pulsed electrical current to the treatment area to provide electrical stimulation. [31] A device according to claim 29 or 30, wherein the electrical stimulation causes muscle contractions of a muscle within the body part. [32] Device according to one of claims 28 to 31, further comprising: a main unit consisting of: the first generator; the second generator; the control unit comprising a processor; and a socket connected to the first generator, the second generator and the control unit; wherein the connector is configured to releasably connect the applicator to the first generator and the second generator via the socket. [33] The device of claim 32, wherein the control unit is configured to detect the connected pad in the socket. [34] A device according to claim 32 or 33, wherein the socket has a safety feature that prevents inadvertent connection of the connector in the socket. [35] The device of any one of claims 28 to 34, further comprising a user interface configured to enable an operator of the device to select the one or more treatment protocols; wherein the control unit is configured to automatically control the radiofrequency energy and the electrical current in accordance with the one or more treatment protocols selected by the operator. [36] The device of claim 35, wherein the one or more treatment protocols comprise a protocol for delivering the pulsed electrical current at a frequency of 0.1 Hz to 12 kHz such that a muscle contraction of at least one of the frontalis muscle, the zygomaticus muscle, the platysma muscle, or the risorius muscle is elicited to provide an aesthetic treatment to the patient. [37] The device of claim 36, wherein the treatment protocol is arranged to provide 600 to 900 contractions per treatment via the pad. [38] Device according to one of claims 35 to 37, wherein the at least one active element comprises a first electrode and a second electrode adapted to apply the electrical current to the body part, wherein the pad is adapted to be attachable to the forehead of the patient, and wherein the first electrode is arranged on a left side of the pad and the second electrode is arranged on a right side of the pad for placement above the frontalis muscle to provide contraction of the frontalis muscle of the patient, and wherein the first electrode is arranged at a distance of 2 cm to 8 cm from the second electrode. [39] The device of claim 38, wherein the pad further comprises a center electrode disposed between the first electrode and the second electrode and configured to deliver the radiofrequency energy to the treatment area. [40] A device according to claim 38 or 39, wherein the pad has a convex projection or a concave depression in the lower central part of the pad. [41] The device of claim 40, wherein the convex projection or concave recess serves as a focal point for correct coupling of the pad to the forehead area of ​​the patient, the convex projection or concave recess being adapted to be aligned with the nose of the patient during treatment. [42] Device according to one of claims 35 to 37, wherein the at least one active element comprises a first electrode and a second electrode, wherein the pad is designed to be applied to the left or right cheek of the patient, and wherein the first electrode and the second electrode are arranged to be placed over at least one of the risorius or zygomaticus muscles of the patient and to cause contraction of at least one of the risorius or zygomaticus muscles to effect skin rejuvenation of the patient. [43] The device of claim 42, wherein the distance between the first electrode and the second electrode is in a range of 0.7 mm to 30 mm. [44] The device of claim 35, wherein the pad is adapted to be attachable to the submentum of the patient, and wherein the at least one active element is adapted to be placed over at least one of the mylohyoid, stylohyoid, digastric, or platysma muscles of the patient. [45] The device of claim 44, wherein the radio frequency energy is a monopolar radio frequency energy configured to heat fatty tissue within the submentum to effect fat reduction, and wherein the surface of a skin of the submentum is heated to a temperature in the range of 37.5°C to 55°C. [46] The device of claim 44 or 45, wherein the pad has a convexo-concave shape comprising at least one arcuate curvature. [47] The device of claim 46, wherein the pad has a banana-shaped structure. [48] ​​Device according to one of claims 35, wherein the at least one active element comprises a first electrode and a second electrode adapted to deliver the pulsed electrical current to the treatment area, wherein the pad is designed to be attached to the forehead of the patient, and wherein the pulsed electrical current is a biphasic alternating TENS current having a frequency in a range of 25 Hz to 1 kHz, intended to provide pain relief. [49] Device according to claim 35, wherein the control unit is designed to supply the pulsed electrical current with a pulse duration in a range of 0.5 µs to 500 ms and a current density of 0.1 mA / cm 2 and 100 mA / cm 2 for the treatment of sleep apnea or snoring; wherein the pad is configured to provide muscle contractions of at least one of the geniohyoid or genioglossus muscles. [50] Apparatus according to claim 48 or 49, wherein the pad has a surface in a range of 10 cm 2 up to 50 cm 2 has.

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