Devices and methods for non-attended treatment of patients

Abstract

To provide a method and a device for minimally invasive to noninvasive electromagnetic energy delivery through a single or a plurality of active elements.SOLUTION: A device for noninvasive treatment for improving visual appearance of a patient includes: a primary electromagnetic wave generator for generating electromagnetic energy; a secondary generator for generating secondary energy; a switching circuit; a pad configured so as to be attached to a treatment area of the body of the patient; at least one active element attached to the treatment area configured so as to deliver electromagnetic energy from the primary electromagnetic wave generator or the secondary energy from the secondary generator to the treatment area; and a CPU for controlling the energy delivered to the at least one active element from the primary electromagnetic wave generator and the secondary energy generator. The at least one active element is disposed on the pad.SELECTED DRAWING: None

Description

Cross-reference of related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 019,619, filed on 4 May 2020, which is incorporated herein by reference in its entirety. [Technical Field]

[0002] The present invention relates to a method and apparatus for treating a patient with an active element, which delivers electromagnetic energy and / or secondary energy so that a treatment area is treated uniformly without the need to manipulate the active element during treatment. [Background technology]

[0003] The delivery of various forms of electromagnetic energy to patients for medical and cosmetic purposes has been widely used in the past. These common procedures include, but are not limited to, skin rejuvenation, wrinkle removal, skin tightening and lifting, cellulite and fat reduction, treatment of pigmented lesions, tattoo removal, soft tissue coagulation and excision, reduction of vascular lesions, facial lifting, muscle contraction and strengthening.

[0004] All of these procedures are performed to improve the patient's visual appearance.

[0005] These procedures also bring certain limitations and associated risks, in addition to the many obvious benefits of thermotherapy. In particular, there are limitations to what can be achieved regarding reproducible results, as these depend heavily on the treatment techniques applied and the skill of the operator. Furthermore, improper treatment increases the risk of burns and adverse events.

[0006] When energy delivery is controlled by the manual movements of the operator's hand, which is the most common procedure, ensuring a uniform energy distribution is extremely difficult. Certain spots can easily be over-treated or under-treated. For this reason, devices have emerged that include scanning or other mechanisms that allow delivery to non-attended skin. These devices typically deliver energy only to a limited, clearly defined area without apparent heterogeneity, and without direct contact with the area being treated. Maintaining the same distance between the tissue being treated and the energy generator, or maintaining the necessary tissue contact, can be difficult when treating areas that are uneven or undulating. Therefore, using commonly available devices on such specific areas (e.g., the face) that vary from patient to patient can be practically impossible.

[0007] The application of non-attached devices to the face is unique due to the complexity arising from the need to attach them to uneven surfaces and adapt them to different patient shapes, in addition to the heightened need to protect against burns and other side effects. While the face heals more easily than other areas of the body, it is also more exposed, presenting much higher requirements for treatment rest periods. Another crucial aspect of facial treatment is that the face is the primary source of the most important human senses, and their function must not be impaired during treatment. Above all, eye safety must be ensured throughout the entire treatment.

[0008] The current beauty market offers either conventional manually controlled radiofrequency or light devices that allow facial tissues to be heated to target temperatures ranging from 40°C to 100°C, or non-attendant LED facial masks that operate based on the effects of light (phototherapy) rather than heat. These masks are primarily intended for home use and do not pose a risk to patients of burns, overheating, or overtreatment. Variations in the shape of individual patients' faces may affect the delivery. Because the energy and temperature reached are very low, the risk of thermal tissue damage is minimized, and uniform treatment is not required; therefore, these masks do not represent any particular problem. Also, due to the low temperature, it is not important for such devices to maintain a predetermined distance between the individual diodes and the patient's skin, and the shape of the mask is merely a very approximate representation of the human face. However, their use is greatly limited due to the low energy and minimal or no thermal effect, and they are considered a preventative tool for routine use rather than a method of in-clinic skin rejuvenation with immediate effects.

[0009] Today, the cosmetic market sees a need to combine thermal therapy, performed by delivering electromagnetic energy to the epidermis, dermis, subcutaneous tissue, or adipose tissue, with secondary energy that induces muscle contraction or stimulation, in the field of improving patients' visual appearance. However, none of the actual devices are adapted to treat uneven areas like the face. Furthermore, commercially available devices are typically handheld devices that need to be operated by a medical professional throughout the entire treatment.

[0010] Therefore, it is necessary to improve medical devices that supply two or more therapeutic energies (e.g., electromagnetic energy and electric current) so that both energies can be delivered through different or the same active element (e.g., electrodes). Furthermore, the applicator or pad of a device that enables non-attending treatment of the patient needs to be attached to the patient. In some embodiments, the applicator or pad is made of a flexible material that allows sufficient contact with the uneven treatment area of ​​the patient's body part. [Overview of the project]

[0011] To enable well-defined, non-attendant treatment of uneven and irregular areas of a patient's body (e.g., facial areas) while maintaining safety, methods and devices for minimally invasive to non-invasive electromagnetic energy delivery via one or more active elements have been proposed.

[0012] The term "patient" can include skin and body parts, and body parts can refer to areas of the body.

[0013] The desired effect of improving the patient's visual appearance may include heating of tissue (e.g., skin) in the range of 40°C to 50°C, tissue coagulation at temperatures of 40°C to 80°C, or tissue ablation at temperatures of 60°C to 100°C. Different patients and skin conditions may require different treatment approaches; higher temperatures allow for better results in fewer sessions but require a longer healing time, while lower temperatures allow for treatment with no downtime but yield limited results in more sessions. Another effect of heating in some embodiments is to reduce the number of fat cells.

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

[0015] Configurations for contact therapy or non-contact therapy have been proposed.

[0016] For contact therapy, the proposed device comprises at least one electromagnetic energy generator in a main unit that generates electromagnetic energy delivered to the treatment area via at least one active element attached to the skin. The at least one active element may be embedded in a pad made of a flexible material that conforms to the shape of the uneven surface. The underside of the pad may include an adhesive layer that allows the active element to adhere to the treatment area and maintain the necessary tissue contact. Furthermore, the device may receive measurements from at least one sensor, for example, a thermal sensor or impedance measuring sensor capable of measuring the quality of contact with the tissue being treated. Based on this, a safety system can be used that allows for the adjustment of one or more treatment parameters.

[0017] For non-contact therapy, the proposed device comprises at least one electromagnetic energy generator within a main unit that generates electromagnetic energy delivered to a treatment area via at least one active element positioned at a predetermined distance from the tissue to be treated. The distance of at least one active element from the treatment area can be monitored before treatment, throughout the treatment, or after treatment. Furthermore, the device may utilize a safety system that can adjust one or more treatment parameters based on measurements from at least one sensor, e.g., one or more distance sensors. Energy can be delivered by one or more static active elements, or by moving one or more active elements across the treatment area, e.g., via a built-in automatic movement system, e.g., an integrated scanner. The treatment area can be defined by the laser field of view, and the operator can mark the area to be treated before treatment.

[0018] If the active element contains a matrix formed by points of a predetermined size, energy can be delivered through its entire surface or by so-called partial arrangement. These points may be separated by inactive (and therefore non-healing) areas that allow for faster tissue healing. The surface of the points can constitute 1% to 99% of the active element area.

[0019] Electromagnetic energy can be generated primarily by lasers, laser diode modules, LEDs, flash lamps or incandescent bulbs, or by high-frequency generators to cause heating of the patient. Furthermore, acoustic or electrical or electromagnetic energy that does not heat the patient may be delivered simultaneously, alternately, or in overlap with the primary electromagnetic energy.

[0020] An active element can deliver two or more energies simultaneously, sequentially, or overlappingly. For example, an active element can deliver high-frequency energy followed by electrical energy (electric current). In another example, an active element can deliver both high-frequency energy and electrical energy simultaneously.

[0021] Furthermore, the device may be configured to deliver an electromagnetic field by at least one active element and simultaneously deliver electrical energy by, for example, different elements.

[0022] Therefore, the proposed methods and devices may result in proper skin rejuvenation of uneven and bumpy areas, wrinkle removal, skin tightening and lifting, reduction of cellulite and fat, treatment of pigmented lesions, tattoo removal, soft tissue coagulation and excision, reduction of vascular lesions, etc., without causing further harm to important parts of the patient's body, such as nerves or internal organs. The proposed methods and devices may result in a reduction of adipose tissue, for example, by lipolysis or apoptosis of adipocytes.

[0023] Furthermore, the proposed methods and devices may lead to tissue rejuvenation, for example, muscle strengthening or muscle tone through muscle contraction induced by electrical or electromagnetic energy. [Brief explanation of the drawing]

[0024] [Figure 1] A block diagram of the apparatus for contact therapy is shown. [Figure 2] This is a diagram of a device for contact therapy. [Figure 3] This shows the shape and layout of the pads. [Figure 4] This image shows a side view of a pad intended for contact therapy. [Figure 5] This demonstrates one variation of energy delivery by switching between multiple active elements. [Figure 6] A block diagram of a device for non-contact therapy is shown. [Figure 7] This is a diagram of a device for non-contact therapy. [Figure 8A] This is a diagram of a framed grid-like electrode. [Figure 8B] This is a diagram of another framed grid electrode. [Figure 8C] This is a diagram of a framed grid-like electrode with thin conductive lines. [Figure 8D] This is a diagram of a grid-like electrode that is not framed. [Figure 9] This is a diagram of the forehead applicator. [Modes for carrying out the invention]

[0025] The presented methods and devices can be used to stimulate and / or treat tissues including but not limited to the skin, epidermis, dermis, subcutaneous tissue, or muscle. The proposed devices are designed for minimally non-invasive treatment of one or more areas of tissue to enable well-defined, non-attendant treatment of uneven areas (e.g., facial areas) by electromagnetic energy delivery via one or more active elements without causing further harm to important parts of the patient's body, such as nerves or internal organs.

[0026] Furthermore, the presented methods and devices can be used to stimulate body parts or regions such as the head, neck, bra fat, flank fat, torso, back, abdomen, buttocks, thighs, calves, legs, arms, forearms, hands, fingers, or body cavities (e.g., vagina, anus, mouth, inner ear, etc.).

[0027] The proposed method and device may include several protocols for improving the visual appearance, which can be pre-programmed into a control unit (which may include, for example, a flexible circuit or printed circuit board and a CPU that may include a microprocessor or memory for controlling the device).

[0028] The desired effects may include heating (thermotherapy) of tissue (e.g., skin) in the range of 37.5°C to 65°C, or 38°C to 60°C, or 39°C to 55°C, or 40°C to 50°C; tissue coagulation at temperatures in the range of 37.5°C to 95°C, or 38°C to 90°C, or 39°C to 85°C, or 40°C to 80°C; or tissue ablation at temperatures in the range of 50°C to 130°C, or 55°C to 120°C, or 60°C to 110°C, or 60°C to 100°C. The device can be operated in a contact or non-contact manner. In contact therapy, the target skin temperature can typically be in the range of 37.5°C to 95°C, 38°C to 90°C, 39°C to 85°C, or 40°C to 80°C, while in non-contact therapy, the target skin temperature can be in the range of 37.5°C to 130°C, 38°C to 120°C, 39°C to 110°C, or 40°C to 100°C. Temperatures in the range of 37.5°C to 130°C, 38°C to 120°C, 39°C to 110°C, or 40°C to 100°C can lead to fibroblast stimulation and the formation of connective tissue—e.g., collagen, elastin, hyaluronic acid, etc. Depending on the target temperature, controlled tissue damage is induced, initiating a physiological repair process and leading to the formation of new tissue. Temperatures within the range of 37.5°C to 130°C, 38°C to 120°C, 39°C to 110°C, or 40°C to 100°C can further alter adipose tissue. During the apoptosis process induced by high temperatures, adipocytes break down into apoptotic bodies, which are further removed through the process of phagocytosis. In a process called necrosis, adipocytes rupture due to high temperatures. The contents are then released into the extracellular matrix. Both processes can result in a reduction of the fat layer, which allows for facial reshaping. Removing fat from the face can be beneficial in areas such as the lower lip subcosa or cheeks.

[0029] Other desired effects may include tissue rejuvenation. For example, this could be muscle strengthening through muscle contraction induced by electrical or electromagnetic energy without applying heat to the patient, or muscle relaxation induced by compression massage. The combined effect of muscle contraction via heating of tissue (e.g., skin) by electrical energy and electromagnetic fields as described herein may result in a significant improvement in visual appearance.

[0030] Figures 1 and 2 will be explained together. Figure 1 shows a block diagram of the device 1 for contact therapy. Figure 2 is a diagram of the device 1 for contact therapy. The device 1 for contact therapy may comprise two main blocks, namely the main unit 2 and the pad 4. Furthermore, the device 1 may comprise an interconnection block 3 or a neutral electrode 7. However, the components of the interconnection block 3 may be mounted on the main unit 2.

[0031] The main unit 2 may include one or more generators, which are preferably a primary electromagnetic generator 6 capable of delivering high-frequency energy in the range of 10 kHz to 300 GHz, 300 kHz to 10 GHz, or 400 kHz to 6 GHz, or in the range of 100 kHz to 550 MHz, 250 kHz to 500 MHz, 350 kHz to 100 MHz, or 400 kHz to 80 MHz; a secondary generator 9 capable of further delivering electromagnetic energy that does not heat the patient, or a current in the range of 1 Hz to 10 MHz, 5 Hz to 5 MHz, or 10 Hz to 1 MHz; and / or an ultrasonic emitter 10 capable of further delivering acoustic energy having a frequency in the range of 20 kHz to 25 GHz, 20 kHz to 1 GHz, 50 kHz to 250 MHz, or 100 kHz to 100 MHz. Furthermore, the frequency of the ultrasonic energy may be in the range of 20 kHz to 80 MHz, 50 kHz to 50 MHz, or 150 kHz to 20 MHz.

[0032] The output power of the high-frequency energy may be 450, 300, 250, or 220 W or less. Furthermore, the high-frequency energy at the output of the primary electromagnetic generator 6 (e.g., high-frequency generator) may be in the range of 0.1 W to 400 W, or 0.5 W to 300 W, or 1 W to 200 W, or 10 W to 150 W. The high-frequency energy can be applied within or near the ISM bands of 6.78 MHz, 13.56 MHz, 27.12 MHz, 40.68 MHz, 433.92 MHz, 915 MHz, 2.45 GHz, and 5.8 GHz.

[0033] The main unit 2 may further include a human-machine interface 8, represented by a display, buttons, keyboard, touchpad, touch panel, or other control element, which allows the operator to check and adjust parameters of treatment and other devices. For example, it may be possible to independently set the power, treatment time, or other treatment parameters of each generator (primary electromagnetic generator 6, secondary generator 9, and ultrasonic emitter 10). The human-machine interface 8 may be connected to the CPU 11. The power supply 5 located in the main unit 2 may include a transformer, disposable batteries, rechargeable batteries, a power plug, or a standard power cord. The output power of the power supply 5 may be in the range of 10W to 600W, 50W to 500W, or 80W to 450W.

[0034] Interconnection block 3 can function as a communication channel between the main unit 2 and the pad 4. It is a simple device including basic indicators 17 and a mechanism for treatment control. It may be represented by a chair. The indicator 17 can be implemented by a display, LED, acoustic signal, vibration, or other form that can provide appropriate notification to the operator and / or patient. The indicator 17 can show the actual patient temperature, contact information or other sensor measurements, as well as the status of the switching process between active elements, the quality of contact with the tissue being treated, actual treatment parameters, treatment in progress, etc. The indicator 17 may be configured to warn the operator in case of suspicious treatment behavior, such as out-of-range temperature, inappropriate contact with the tissue being treated, or automatically adjusted parameters. The interconnection block 3 can be used as an additional safety feature for heat-sensitive patients. It may include an emergency stop button 16 so that the patient can immediately stop treatment at any time during treatment. The switching circuit 14 can be responsible for switching between active elements or adjusting energy delivery from the primary electromagnetic generator 6, secondary generator 9, or ultrasonic emitter 10. The switching speed between active elements 13 may depend on the amount of energy delivered, pulse length, etc., and / or the speed of the switching circuit 14 and CPU 11. The switching circuit 14 may include a relay switch, a transistor (bipolar, PNP, NPN, FET, JFET, MOSFET), a thyristor, a diode, or an opto-mechanical switch, or any other suitable switch known in the prior art. The switching circuit associated with the CPU can control the switching between the primary electromagnetic energy generated by the primary electromagnetic generator 6 and the secondary energy generated by the secondary generator 9 using at least one active element.

[0035] Furthermore, the interconnection block 3 may include a primary electromagnetic generator 6, a secondary generator 9, or an ultrasonic emitter 10, or one of them, or any combination thereof.

[0036] CPU11 has a primary electromagnetic energy of 10 mJ / cm². 2 From 50 kJ / cm² 2 The range of, or 100 mJ / cm² 2 From 10 kJ / cm²2 Within the range of 0.5 J / cm², or 0.5 J / cm². 2 From 1 kJ / cm² 2The primary electromagnetic generator 6 is controlled so that it can be delivered in continuous mode (CM) or pulsed mode to at least one active element having a fluence in the range of . Electromagnetic energy can be generated primarily by a laser, laser diode module, LED, flash lamp or incandescent bulb, or by a high-frequency generator to cause heating of the patient. The CM mode can be operated at time intervals ranging from 0.05 seconds to 60 minutes, or from 0.1 seconds to 45 minutes, or from 0.2 seconds to 30 minutes. The pulse duration of energy delivery operating in the pulsed region may be in the range of 0.1 milliseconds to 10 seconds, or from 0.2 milliseconds to 7 seconds, or from 0.5 milliseconds to 5 seconds. The primary electromagnetic generator 6 in the pulsed region can be operated by the CPU 11 in single-shot mode or repetitive mode. The frequency in repetitive mode may be in the range of 0.05 to 10000 Hz, or from 0.1 to 5000 Hz, or from 0.3 to 2000 Hz, or from 0.5 to 1000 Hz. Alternatively, the frequency of the repetition mode may be in the range of 0.1 kHz to 200 MHz, or 0.5 kHz to 150 MHz, or 0.8 kHz to 100 MHz, or 1 kHz to 80 MHz. The single-shot mode may mean the generation of just one electromagnetic pulse with specific parameters (e.g., intensity, duration, etc.) for delivery to a single treatment area. The repetition mode may mean the generation of one or more electromagnetic pulses, which may have specific parameters (e.g., intensity, duration, etc.) at the repetition rate of the aforementioned frequencies for delivery to a single treatment area. The CPU 11 can provide control over the treatment, such as stabilization of treatment parameters including treatment time, power, duty cycle, the period for adjusting switching between multiple active elements, the temperature of device 1, and the temperatures of the primary electromagnetic generator 6 and secondary generator 9 or ultrasonic emitter 10. The CPU 11 can drive the switching circuit 14 to provide information. The CPU 11 can also receive and provide information from sensors located on or within the pad 4, or somewhere on device 1. PU11 may include a flexible circuit or a printed circuit board, and may also include a microprocessor or a memory for controlling the device.

[0037] CPU11 can control the secondary generator 9 so that secondary energy (e.g., current or magnetic field) can be delivered to at least one active element having a fluence in the range of 10 mJ / cm 2 to 50 kJ / cm 2 or in the range of 100 mJ / cm 2 to 10 kJ / cm 2 or in the range of 0.5 J / cm 2 to 1 kJ / cm 2 in a continuous mode (CM) or a pulse mode. Applying secondary energy to the treatment area of the patient can cause muscle contraction of the patient. The CM mode can be operated at time intervals in the range of 0.05 seconds to 60 minutes, or in the range of 0.1 seconds to 45 minutes, or in the range of 0.2 seconds to 30 minutes. The pulse duration of the delivery of secondary energy operating in the pulse region can be in the range of 0.1 microseconds to 10 seconds, or in the range of 0.2 microseconds to 1 second, or in the range of 0.5 microseconds to 500 milliseconds. The secondary generator 9 in the pulse region can be operated by the CPU11 in a single-shot mode or a repetitive mode. The frequency of the repetitive mode can be in the range of 0.1 to 12000 Hz, or in the range of 0.1 to 8000 Hz, or in the range of 0.1 to 5000 Hz, or in the range of 0.5 to 1000 Hz.

[0038] The proposed device may be a multi-channel device that enables the CPU11 to control the treatment of multiple treatment areas at once.

[0039] Alternatively, the interconnection block 3 does not have to be part of device 1, and the CPU 11, switching circuit 14, indicator 17, and emergency stop unit 16 may be part of the main unit 2 or pad 4. Furthermore, some of the CPU 11, switching circuit 14, indicator 17, and emergency stop unit 16 may be part of the main unit 2, and some of them may be part of pad 4. For example, the CPU 11, switching circuit 14, and emergency stop unit 16 may be part of the main unit 2, and the indicator 17 may be part of pad 4.

[0040] Pad 4 represents the portion of the device that may come into contact with the patient's skin during treatment. Pad 4 may be made of a flexible substrate material, such as a polymer-based material, polyimide (PI) film, Teflon®, epoxy, polyethylene terephthalate (PET), polyamide, or PE foam, and may have an additional adhesive layer on the underside, such as a hypoallergenic adhesive gel 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 from a fabric, such as a nonwoven fabric. The adhesive layer may have an impedance to current at a frequency of 500 kHz in the range of 1 to 150 Ω, or 5 to 130 Ω, or 10 to 100 Ω, and the impedance to current at frequencies below 100 Hz is at least three times the impedance to current at 500 kHz. The adhesive hydrogel may be made from a polymer matrix or mixture containing water, polyhydric alcohols, polyvinylpyrrolidone, polyisocyanate components, polyol components, or having a methylenediphenyl structure in its main chain. Furthermore, the conductive adhesive may be reinforced with metal fillers such as silver, gold, copper, aluminum, platinum, titanium, or graphite, which constitute 1 to 90%, 2 to 80%, or 5 to 70% of the adhesive. The adhesive layer may be covered with "ST-gel®" or "Tensive®" conductive adhesive gel, which is applied to the body to reduce its impedance and thereby facilitate the delivery of electric shock.

[0041] The adhesive layer beneath pad 4 may mean that the adhesive layer is located between the surface of the pad facing the patient and the patient's body. The adhesive layer may have an impedance 1.1 times, 2 times, 4 times, or up to 10 times higher than the impedance of the patient's skin beneath pad 4. The definition of impedance may be that it is a portion of the total impedance measured between two equipotential surfaces in contact with the epidermis, i.e., inversely proportional to the area of ​​the electrodes, when the internal current flux path is kept constant. Data applicable to this definition are conveniently recorded as admittance per unit area to facilitate application to other geometric shapes. The impedance of the adhesive layer can be set by the same experimental setup used to measure skin impedance. The impedance of the adhesive layer may be higher than the impedance of the skin by a coefficient ranging from 1.1 to 20 times, or from 1.2 to 15 times, or from 1.3 to 10 times.

[0042] The impedance of the adhesive layer may have different values ​​for different types of energy delivered to the patient; for example, the impedance may differ for the delivery of high-frequency and current. The impedance of the hydrogel may range from 100 to 2000 ohms, or from 150 to 1800 ohms, or from 200 to 1500 ohms, or from 300 to 1200 ohms, when current (e.g., during electrotherapy) is delivered.

[0043] Pad 4 may also have a sticker on its upper surface. The upper surface is the portion opposite to the lower surface (the side on which the adhesive layer may be deposited), in other words, the upper surface is the side of the pad that faces outward from the patient during treatment. The sticker may have a bottom surface and a top surface, the bottom surface of the sticker may include an adhesive layer, and the top surface of the sticker may include a non-adhesive layer (e.g., polyimide (PI) film, Teflon®, epoxy, polyethylene terephthalate (PET), polyamide, or PE foam).

[0044] The sticker may have the same shape as pad 4, or it may have an additional overlap on the pad. The sticker may be adhered to the pad such that the adhesive layer on the bottom of the sticker faces the top surface of pad 4. The top surface of the sticker facing outward from pad 4 may be made of a non-adhesive layer. The size of the sticker with the additional overlap can extend beyond the pad by 0.1 to 10 cm, or 0.1 to 7 cm, or 0.2 to 5 cm, or 0.2 to 3 cm. This overlap may also include an adhesive layer and may be used to form additional, better contact between the pad and the patient.

[0045] Alternatively, the pad 4 may include at least one suction opening, for example, a small cavity or slit adjacent to the active element, or the active element may be embedded inside the cavity. The suction opening may be connected via a connecting tube to a pump, which may be part of the main unit 2. When the suction opening comes into contact with the skin, air drawn in from the suction opening flows toward the connecting tube and the pump, causing the skin to be slightly drawn into the suction opening. Thus, by applying vacuum, adhesion of the pad 4 can be achieved. Furthermore, the pad 4 may be provided with an adhesive layer and a suction opening to combine for stronger adhesion.

[0046] In addition to vacuum (negative pressure), pumps can also supply positive pressure by pressurizing fluid into a suction opening. 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 a room during treatment.

[0047] Pressure (positive or negative) may be applied to the treatment area in pulses that provide massage therapy. Massage therapy may also be performed by one or more suction openings that vary the value of the pressure applied to the patient's soft tissue, meaning that the suction openings apply different pressures to the patient's tissue. Furthermore, the suction openings can create a pressure gradient in the soft tissue without touching the skin. Such pressure gradients can target soft tissue layers, subsurface, and / or different soft tissue structures.

[0048] Massage accelerates and improves therapeutic treatment by using non-heating electromagnetic energy, electrical energy, or electromagnetic energy to improve blood and / or lymphatic circulation, angioedema, erythema, fat removal, metabolism, and elastic formation and / or neogenesis.

[0049] Each suction opening can be supplied with pressure by a suction mechanism, a flow of air or gas, a flow of liquid, pressure supplied by an object contained within the suction opening (e.g., an object to be massaged, a pressure cell, etc.), and / or by other means.

[0050] The pressure values ​​applied to the patient's tissues mean that the suction openings that produce the massage effect apply positive, negative, and / or sequentially changing positive and negative pressures to the treated and / or adjacent patient tissue structures and / or create a pressure gradient beneath the patient's tissue surface.

[0051] Massage applied to improve fluid flow (e.g., lymphatic drainage) and / or relax the tissues of the surface soft tissue layers may be applied at lower pressures than during massage of deeper soft tissue layers. Such positive or negative pressures compared to atmospheric pressure may range from 10 Pa to 30,000 Pa, or from 100 Pa to 20,000 Pa, or from 0.5 kPa to 19 kPa, or from 1 kPa to 15 kPa.

[0052] Massage applied to improve fluid flow and / or relaxation of deeper soft tissue layers may be applied at higher pressures. Such positive or negative pressures may range from 12 kPa to 400 kPa, or from 15 kPa to 300 kPa, or from 20 kPa to 200 kPa. Pressure thresholds can be set according to individual patient feedback, using discomfort caused by excessively high pressure.

[0053] Negative pressure can stimulate the flow of bodily fluids and / or relaxation of the deep soft tissue layers (up to 0.5 cm to an unspecified depth of soft tissue) and / or the soft tissue layers near the patient's surface (0.1 mm to 0.5 cm). To enhance the effectiveness of massage, negative pressure therapy may be used followed by positive pressure therapy.

[0054] The number of suction openings that vary the pressure value of the patient's soft tissue in one pad 4 may be between 1 and 100, or between 1 and 80, or between 1 and 40, or between 1 and 10.

[0055] The size and / or shape of the suction opening may vary depending on the characteristics of the treatment area. One suction opening may be 0.1 mm. 2 1cm 2 , or 0.1mm 2 From 50mm 2 , or 0.1mm 2 From 40mm 2 , or 0.1mm 2 From 20mm 2 It can cover an area of ​​the patient's surface. Another suction opening is 1 cm. 2 1m 2 , or 1cm 2 From 100cm 2 , or 1cm 2 50cm 2 , or 1cm 2 40cm 2 It can cover a surface area of ​​the patient.

[0056] Several suction openings may function simultaneously, or the switching between them may occur at intervals of 1 millisecond to 10 seconds, or 10 milliseconds to 5 seconds, or 0.5 seconds to 2 seconds.

[0057] The suction opening for producing a massage effect may be guided according to one or more predetermined massage profiles included in one or more treatment protocols. The massage profile can be selected by the operator and / or CPU in relation to the patient's condition. For example, a patient with lymphedema may have a different massage profile than a patient with lower limb ulcers to be healed. Bell's compression profile and applied pressure may be required.

[0058] The pressure applied by one or more suction openings may preferably be gradually applied in the positive direction of lymphatic flow and / or intravenous blood flow. According to a specific treatment protocol, the pressure may also be gradually applied in the opposite or different direction to normal lymphatic flow. The value of the pressure applied during treatment may vary according to the treatment protocol.

[0059] A pressure gradient may occur between individual suction openings. Examples of gradients described are not limited to this method and / or device. The pressure gradient between at least two preceding suction openings and a successor suction opening may be set to 0%, i.e., the pressure applied by the suction openings is the same (e.g., the pressure at all suction openings in the pad is the same), 1%, i.e., the pressure applied between the preceding and successor suction openings decreases and / or increases with a 1% gradient (e.g., the pressure at the first suction opening is 5 kPa and the pressure at the successor suction opening is 4.95 kPa), or 2%, i.e., the pressure decreases or increases with a 2% gradient. The pressure gradient between two suction openings can range from 0% to 100%, where 100% means that one suction opening is not active and / or does not apply any pressure to the patient's soft tissue.

[0060] The treatment protocol controlling the application of a pressure gradient between the previous suction opening and the successive suction opening may range from 0.1% to 95%, or from 0.1% to 70%, or from 1% to 50%.

[0061] The suction opening may also include an impact massager powered by a piston, a massager operated by filling or sucking liquid or air from the volume portion of the gap by an inlet / outlet valve, or a massager powered by an element that generates an electric field, magnetic field, or electromagnetic field. Furthermore, the massage may be brought about by the striking of multiple massagers. The multiple massagers may be the same or different in size, shape, and weight, or may be made from the same or different materials. The massagers may be accelerated by air or liquid flowing (through a valve), or by an electric field, magnetic field, or electromagnetic field. The trajectory of the massagers may be random, circular, or linear, and / or the massagers may rotate around one or more axes, and / or perform other types of motion in the volume portion of the gap.

[0062] The massage unit may also be equipped with a membrane on the patient-facing side that can be accelerated by an electric field, magnetic field, electromagnetic field, or by changing the pressure value of the volume of the gap between the chamber wall and the membrane. This membrane can act as a massage object. During treatment, it may be convenient to use a combination of a pad with an adhesive layer and a pad with a suction opening. 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, a pad with an adhesive layer may be suitable for treating more uneven areas, such as the periorbital region, while a pad with a suction opening may be suitable for treating smoother areas, such as the cheek.

[0063] An advantage of devices in which the pad attachment may be provided by an adhesive layer, a suction opening, or a combination thereof is that there is no need for any additional gripping system, such as a band or felt, that would need to hold the pad in place in the treatment area during treatment, which could cause discomfort to the patient.

[0064] In yet another embodiment, the flexible pad 4 is secured to the face by at least one band or felt made of an elastic material and thus adjustable to fit an individual face. This is possible. In this case, the flexible pad, which may not have an adhesive layer or suction openings, is placed in the patient's treatment area, and its position is then secured by a band or felt to prevent the pad from flexing away from the treatment area. Alternatively, the band may be replaced by an elastic mask that covers 5% to 100%, or 30% to 99%, or 40% to 95%, or 50% to 90% of the face and can help secure the flexible pad to the treatment area. Furthermore, it may be possible to use a combination of a pad with an adhesive layer or suction openings and a fastening band, felt, or mask to ensure a firm attachment of the pad to the treatment area.

[0065] Furthermore, the fastening mechanism may be in the form of a fabric or garment that can be attached to a part of the user's body. When the device is in use, the surface of the electrode or electrode pad 4 is along the inner surface of the garment, while the opposite surface of the electrode or electrode pad 4 is in contact with the user's skin, preferably by a skin-electrode hydrogel interface.

[0066] The garment can be fastened to or around the user's body by means of, for example, hook-and-loop fasteners, buttons, buckles, studs, strings or cords, magnetic induction locking systems or clamp bands, and the garment can be made of a flexible material or fabric that conforms to the shape of the user's body or limbs. The electrode pads 4 may similarly be configured to be fixed to the inner surface of the garment. The garment is preferably made of a breathable material. Non-limiting examples of such materials are soft neoprene, nylon, polyurethane, polyester, polyamide, polypropylene, silicone, cotton, or any other soft and flexible material. All specified materials can be used as woven fabrics, nonwoven fabrics, disposable cloths or laminated structures.

[0067] The clothing and pads may be a modular system, meaning that the modules or elements of the device (pads, clothing) and / or the system are designed to be compatible with each other, while also being separate and independent from the remaining modules or elements.

[0068] Pad 4 may be attached to clothing or designed to contact clothing, and is therefore carried by clothing in a stationary or fixed state so that the pad is positioned in a fixed location on the clothing. The clothing ensures that the pad adheres or is positioned correctly to the user's skin. In use of the device, the surfaces of one or more active elements that are not in contact with the clothing are preferably in contact with the patient's skin by a hydrogel layer that acts as a pad-skin interface. Thus, the active elements contained in the pad are in contact with the patient's skin.

[0069] The optimal placement of pads on the patient's body parts, and therefore the clothing that carries the pads containing the active elements, can be determined by a technician or clinician assisting the patient.

[0070] Furthermore, clothing may contain two or more pads, or a patient may wear two or more garments containing one or more pads during a single treatment session.

[0071] The pad 4 may include at least one active element 13 capable of delivering energy from a primary electromagnetic generator 6 or a secondary generator 9 or an ultrasonic emitter 10. The active element may be in the form of an electrode, an optical element, an acoustic window, an ultrasonic emitter, or other energy delivery element 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 unipolar, bipolar, unipolar, or multipolar. A bipolar configuration may consist of electrodes that alternately perform an active function and a return function, in which case the temperature gradient under the electrodes is approximately the same during treatment. The bipolar electrode may form a circular or elliptical shape, and the electrodes may be concentric with each other. However, a group of bipolar electrode systems can also be used. Unipolar electrodes or one or more multipolar electrodes can also be used. The system may alternatively use a monopolar electrode, where the so-called return electrode has a larger surface area than the so-called active electrode. Thus, the thermal gradient under the active electrode is higher than under the return electrode. The active electrode may be part of the pad, and a passive electrode with a larger surface area may be located at least 5 cm, 10 cm, or 20 cm from the pad. A neutral electrode may be used as the passive electrode. The neutral electrode may be on the patient's body opposite to where the pad is attached. Unipolar electrodes can also be used optionally. During energy delivery in a unipolar configuration, there is one electrode, no neutral electrode, and a large RF field is radiated in an omnidirectional field around the single electrode. Capacitive electrodes and / or resistive electrodes may be used. The radio frequency energy is 0.001 W / cm². 2 From 1500W / cm² 2 Or 0.01 W / cm² 2 From 1000W / cm² 2 Or 0.5 W / cm² 2 From 500W / cm 2 Or 0.5 W / cm² 2 From 100W / cm 2 or 1 W / cm 2 From 50W / cm 2 Within this range, a bundle of energy can be supplied to the surface of the active element 13 or to the surface of the tissue being treated (e.g., skin). The bundle of energy on the surface of the active element 13 can be calculated from the size of the active element 13 and its output energy value. The bundle of energy on the surface of the tissue being treated can be calculated from the size of the tissue being treated directly beneath the active element 13 and its input energy value supplied by the active element 13. Furthermore, the RF electrodes placed on the pad 4 can act as acoustic windows for ultrasonic energy.

[0072] The active element 13 can receive secondary energy from the secondary generator 9 in the form of an electric current or a magnetic field. By applying secondary energy to the treatment area of ​​the patient's body, muscle fiber stimulation can be achieved, thus increasing muscle tone, muscle strengthening, restoration of sensation within the muscle, relaxation of muscle tissue, and / or stretching of muscle tissue.

[0073] The proposed device can perform electrotherapy when the secondary energy delivered by the active element 13 (e.g., a high-frequency electrode, or simply an electrode) is an electric current. The main effects of electrotherapy are analgesia, muscle relaxation, iontophoresis, anti-edema effects, or muscle stimulation that induces muscle fiber contraction. Each of these effects can be achieved by one or more types of electrotherapy, namely galvanic current, pulsed DC current, and AC current.

[0074] A galvanic current (or "continuous") is a current that can have a constant current, and / or whose absolute value is greater than 0 at any given moment. It may be used primarily for iontophoresis or for its nutritional stimulating (congestive) effect. In this invention, this current can be replaced with a galvanic intermittent current. Furthermore, although the galvanic component may be about 95%, the frequency can reach 5–12 kHz, 5–10 kHz, 5–9 kHz, or 5–8 kHz due to interruptions in the originally continuous intensity.

[0075] Pulsed direct current (DC) is variable in intensity but has only one polarity. The basic pulse shape may vary. This includes, for example, single-polarity diadynamics, rectangular, triangular, and exponential pulses. Depending on the frequency and intensity used, it may have stimulant, tropic, analgesic, muscle relaxant, iontophoresis, at least partial muscle contraction, and anti-edema effects and / or other effects.

[0076] Alternating current (AC or two-phase) is one in which the basic pulse shape can vary, being rectangular, triangular, harmonic sine wave, exponential and / or other shapes, and / or combinations of the above. It can be alternating, symmetrical and / or asymmetrical. The use of alternating current in contact electrotherapy means much lower stress on the tissue beneath the electrode. For these types of currents, the capacitive component of skin resistance is involved, and therefore these currents are very well tolerated by the patient.

[0077] AC therapy can be classified into five subtypes: TENS, classical (quadripolar) interference, bipolar interference, equiplane interference, and dipole vector field. There are also variations in the electrotherapy energy, the modularity of the period, and the shape of the energy.

[0078] Interferential electrotherapy allows for the creation of pulse envelopes for nerve and tissue stimulation at frequencies such as sympathetic nerves (0.1 to 5 Hz), parasympathetic nerves (10 to 150 Hz), motor nerves (10 to 50 Hz), smooth muscle (0.1 to 10 Hz), sensory nerves (90 to 100 Hz), and nociceptive fibers (90 to 150 Hz) by stimulating different nerve and tissue structures with medium frequencies in the range of 500 Hz to 12 kHz, 500 Hz to 8 kHz, or 500 Hz to 6 kHz.

[0079] Electrotherapy can stimulate the body with currents at frequencies ranging from 0.1 Hz to 12 kHz, 0.1 Hz to 8 kHz, or 0.1 Hz to 6 kHz.

[0080] Electrotherapy-induced muscle fiber stimulation can be important during and / or as part of RF therapy. Muscle stimulation increases blood flow and lymphatic circulation. This can improve the removal of cells being treated and / or prevent the formation of hot spots. Furthermore, internal massage stimulation of adjacent tissues improves tissue uniformity and the distribution of delivered energy. Electrotherapy-induced muscle fiber stimulation can induce muscle contractions, which can lead to an improvement in the patient's visual appearance through muscle hardening and strengthening. Another beneficial effect is, for example, during fat removal with RF therapy. RF therapy can alter the structure of adipose tissue. Muscle fiber stimulation can provide an internal massage that may be more effective for obese patients than classical massage.

[0081] Muscle stimulation can be supplied, for example, by intermittent direct current, alternating current (medium frequency and TENS current), Faradic current as a method for multiple stimuli, and / or other means.

[0082] The current frequency may be in the range of 0.1 Hz to 1500 Hz, or 0.1 to 1000 Hz, or 0.1 Hz to 500 Hz, or 0.1 to 300 Hz.

[0083] The frequency of the current envelope is typically in the range of 0.1 Hz to 500 Hz, or 0.1 to 250 Hz, or 0.1 Hz to 150 Hz, or 0.1 to 140 Hz.

[0084] Electrical stimulation can be supplied in combinations that can achieve a variety of therapies with various effects. As an exemplary example, electromagnetic energy accompanied by electrical stimulation may be administered in a pulsed current train in which a first series of electrical stimulations can achieve a different effect from a second or other consecutive series of stimulations. Thus, the therapy can result in muscle fiber stimulation or contraction, followed by relaxation, during continuous or pulsed high-frequency thermal heating supplied by electromagnetic energy provided by an electromagnetic energy generator.

[0085] Electrical stimulation may be provided in unipolar, bipolar, or multipolar modes.

[0086] Operated in bipolar multipolar mode (current flow between three or more electrodes), and / or provided on at least one electrotherapy electrode, the absolute value of the voltage between the electrotherapy electrodes may be in the range of 0.8V to 10kV, or 1V to 1kV; or 1V to 300V, or 1V to 100V.

[0087] The current density of electrotherapy for non-galvanic currents is 0.1 mA / cm². 2 150m from A / cm 2 The range, or 0.1 mA / cm². 2 From 100mA / cm 2 The range, or 0.1 mA / cm². 2 From 50mA / cm 2 The range, or 0.1 mA / cm². 2 From 20mA / cm 2 It can be in the range of, and the galvanic current is preferably 0.05 mA / cm². 2 From 3mA / cm 2 The range, or 0.1 mA / cm². 2 From 1 mA / cm 2 The range is 0.01 mA / cm², or 0.01 mA / cm². 2 From 0.5 mA / cm 2 It may be within this range. The current density can be calculated at the surface of the electrodes used to administer electrotherapy to the patient.

[0088] During electrotherapy, such as bipolar electrotherapy, two or more electrodes may be used. If the polarity of at least one electrode in the electrode group is non-zero during bipolar mode, the electrode group must include at least one electrode with the opposite polarity. The absolute values ​​of the polarities of both electrodes may or may not be equal. In bipolar electrical stimulation mode, the stimulation signal passes through the tissue between electrodes with opposite polarities.

[0089] The distance between the two electrodes operating in bipolar mode may be in the range of 0.1 mm to 4 cm, or 0.2 mm to 3 cm, or 0.5 mm to 2 cm, or 1 mm to 1 cm, or 0.1 cm to 40 cm, or 1 cm to 30 cm, or 1 cm to 20 cm.

[0090] During unipolar electrotherapy mode, the stimulation signal may be induced by the excitation of an action potential by changing the polarity of one electrode, which alters the polarization of nerve fibers and / or neuromuscular disease.

[0091] During electrotherapy, one of either a bipolar or unipolar electrotherapy mode may be used, or a combination of both modes may be used.

[0092] The ultrasonic emitter can supply focused or unfocused ultrasonic energy. The ultrasonic energy may be transmitted to the tissue through an acoustic window. The output power of the ultrasonic energy on the surface of the active element 13 may be 20W or less, 15W or less, 10W or less, or 5W or less. The ultrasonic energy is 0.001 W / cm². 2 From 250W / cm 2 Within the range of 0.005 W / cm², or 0.005 W / cm². 2 From 50W / cm 2 Within the range of 0.01 W / cm², or 0.01 W / cm². 2 From 25W / cm 2 Within the range of 0.05 W / cm², or 0.05 W / cm². 2 From 20W / cm 2 Within this range, a bundle of energy can be delivered to the surface of the active element 13 or the surface of the tissue being treated (e.g., skin). The treatment depth of the ultrasonic energy may range from 0.1 mm to 100 mm, or from 0.2 mm to 50 mm, or from 0.25 mm to 25 mm, or from 0.3 mm to 15 mm. At a depth of 5 mm, the ultrasonic energy is 0.01 W / cm². 2 From 20W / cm 2 Or 0.05 W / cm² 2 From 15W / cm 2It can supply a beam of energy in the range of 0.1 to 20 or 2 to 15 to 4 to 10. The ultrasonic beam has a beam heterogeneity ratio (R) in the range of 0.1 to 20 or 2 to 15 to 4 to 10. BN ) may have. Furthermore, the ultrasonic beam may have a beam heterogeneity ratio of less than 15 or less than 10. The ultrasonic beam may diverge, converge, and / or collimate. Ultrasonic energy may be transmitted to the tissue through an acoustic window. An RF electrode may act as an acoustic window. Furthermore, the ultrasonic emitter 10 may be part of the active element 13, and therefore the ultrasonic emitter 10 may be part of the pad 4.

[0093] At least some of the active elements 13 may deliver energy from the primary electromagnetic generator 6 or the secondary generator 9 or the ultrasonic emitter 10 simultaneously, sequentially, overlappingly, or in any combination thereof. For example, the active elements 13 may sequentially deliver high-frequency energy and current, so that the active elements 13 first supply the primary electromagnetic energy generated by the primary electromagnetic generator 6, and then the active elements 13 supply the secondary energy generated by the secondary generator 9. This could mean that the active element 13 can, for example, apply high-frequency energy to the patient's tissue, and then the same active element 13 can, for example, apply electric current to the patient's tissue.

[0094] Pad 4 may further include a thermal sensor 15 that enables temperature control during treatment, provides feedback to the CPU 11, allows adjustment of treatment parameters for each active element, and provides information to the operator. The thermal sensor 15 may be a contact sensor, a non-contact sensor (e.g., an infrared temperature sensor), or an invasive sensor (e.g., a thermocouple) for accurate temperature measurement of the deep layers of the skin, such as the epidermis, dermis, or subcutaneous tissue. The CPU 11 may also use an algorithm to calculate the deep or uppermost temperature. The temperature feedback system can control the temperature and warn the operator in a human-perceptible form based on set or preset limits, for example, through the human-machine interface 8 or via the indicator 17. At critical temperature conditions, the device may be configured to adjust one or more treatment parameters, such as output power, switching mode, pulse length, etc., or to stop treatment. Human-perceptible warnings may be voice, warning messages, or color changes of any part of the interconnection block 3 or pad 4, shown on the human-machine interface 8 or indicator 17.

[0095] Memory 12 may contain information such as the type and shape of pad 4, the remaining lifespan of the pad, or the time of treatment already performed on the pad.

[0096] The neutral electrode 7 can ensure proper high-frequency distribution within the patient's body for a unipolar high-frequency system. The neutral electrode 7 is attached to the patient's skin before each treatment so that energy can be distributed between the active element 13 and the neutral electrode 7. In some bipolar or multipolar high-frequency systems, a neutral electrode is not required, and the high-frequency energy is distributed among multiple active elements 13. The neutral electrode 7 can integrate any type of high-frequency system and therefore represents any block of the apparatus 1.

[0097] Furthermore, device 1 may include one or more sensors. A sensor may provide information about at least one physical quantity, the measured value of which may result in feedback that can be displayed by a human-machine interface 8 or indicator 17. One or more sensors may be used to sense delivered electromagnetic energy, skin impedance, skin resistance, temperature of treated skin, temperature of untreated skin, temperature of at least one layer of skin, water content of the device, phase angle of delivered or reflected energy, position of the active element 13, position of the interconnection block 3, temperature of the cooling medium, temperature of the primary electromagnetic generator 6 and secondary generator 9 and ultrasonic emitter 10, or contact with skin. The sensors may be thermal sensors, acoustic sensors, vibration sensors, electrical sensors, magnetic sensors, flow sensors, position sensors, optical sensors, imaging sensors, pressure sensors, force sensors, energy flux sensors, impedance sensors, current sensors, Hall sensors, or proximity sensors. The sensors may be capacitive displacement sensors, acoustic proximity sensors, gyroscopes, accelerometers, magnetometers, infrared cameras, or thermographic cameras. The sensors may be invasive or non-contact. The sensor may be located on or within the pad 4, within the main unit 2, within the interconnection block 3, or as part of the thermal sensor 15. A single sensor may measure multiple physical quantities. For example, the sensor may include a combination of a gyroscope, an accelerometer, and / or a magnetometer. Furthermore, the sensor may measure one or more physical quantities of treated or untreated skin.

[0098] A resistance sensor can measure skin resistance, which can vary from patient to patient. Humidity—wetting and sweat—affects resistance, and thus the energy field of the skin. This is because it can affect skin behavior. Based on the measured skin resistance, skin impedance can also be calculated.

[0099] Information from one or more sensors can be used, for example, to generate pathways on a model, such as a model of the human body shown on the display of the human-machine interface 8. These pathways may represent the surface or volume of tissue that has already been treated, is currently being treated, is being treated, or is not being treated. The model may also show a temperature map of the tissue being treated, while providing information about the tissue that has already been treated or is not being treated.

[0100] Sensors can provide information about the location of bones, inflamed tissues, or joints. Such types of tissues may not be targeted by electromagnetic energy due to the potential for painful treatment. Bones, joints, or inflamed tissues can be detected by any type of sensor, such as imaging sensors (ultrasound sensors, IR sensors) or impedance sensors. The detected presence of these tissue types can cause a disruption in the generation of general human-perceptible signals or electromagnetic energy. Bones can be detected by changes in tissue impedance or by analysis of reflected electromagnetic energy.

[0101] The patient's skin over at least one treatment area may be pre-cooled to a selected temperature over a selected period of time, the selected temperature and period for pre-cooling being sufficient to cool the skin to at least a selected temperature lower than normal body temperature. The skin may be cooled to at least a selected temperature to a depth below at least one depth of the treatment area, such that at least one treatment area is substantially surrounded by the cooled skin. Cooling may be continued during the application of energy, and the duration of energy application may be longer than the thermal relaxation time of the treatment area. Cooling may be brought about by any known mechanism, including water cooling, spray coolant, the presence of an active solid cooling element (e.g., a thermoelectric cooler), or cooling of airflow. The cooling element may act as an optical element, or the cooling element may be a spacer. Cooling may be performed during, before, or after treatment with electromagnetic energy. Pre-treatment cooling may also provide an environment for rapid thermal shock, while post-treatment cooling may result in faster regeneration after thermal shock. The temperature of the coolant may be in the range of -200°C to 36°C. The temperature of the cooling element during treatment may be in the range of -80°C to 36°C, -70°C to 35°C, or -60°C to 34°C. Furthermore, if the pad is not in contact with the patient's skin, cryogenic spray cooling, gas flow, or other non-contact cooling techniques can be utilized. In addition to, or instead of, one of the above cooling techniques, a cooling gel on the skin surface can also be used.

[0102] Figures 3A and 3B show different shapes and layouts of pads 4 used by the device for contact therapy. Pads 4 may be available in various shapes and layouts so that they cover a variety of different treatment areas and can accommodate the needs of individual patients, e.g., annular, semicircular, elliptical, oblong, square, rectangular, trapezoidal, polygonal, or amorphous (not having a regular shape or form). The shape and layout of pads 4 may be such that they cover at least a portion of one or more of the following areas: periorbital area, forehead (including frown lines), jawline, perioral area (including marionette lines, perioral lines - so-called smoking lines, nasolabial folds, lips and chin), cheek or lower lip subproximal. The shape of pads 4 and the distribution, size, and number of active elements 13 may vary depending on the area being treated; for example, the active elements 13 in pads 4 may be in one, two, three, four, or more rows. The pad 4 having the active elements 13 may be of various shapes, for example, arranged in a row, with the centers of at least two of the active elements 13 being in a straight line, and any additional centers of the active elements 13 being in the same or different rows within the pad 4.

[0103] In addition, pad 4 may be used to treat at least partially the neck, bra fat, flank fat, torso, back, abdomen, buttocks, thighs, calves, legs, arms, forearms, hands, fingers, or body cavities (e.g., vagina, anus, mouth, inner ear, etc.).

[0104] The pad 4 may have a rectangular, oval, square, trapezoidal shape, or a convex or concave polygonal shape, and the pad 4 may have at least two different interior angles of the convex or concave polygonal structure. Furthermore, the pad 4 can at least partially form a conical cross-section (also called a cone), for example, a circle, ellipse, parabola, or hyperbola. The pad 4 may be 0.002 to 10 mm -1 The range, or 0.004 to 5 mm -1 The range, or 0.005 to 3 mm -1 The range, or 0.006 to 2 mm -1The shape of the arc has a curvature k in the range of 1, 2, 3, 4, 5, or more of the curvatures of at least one, two, three, four, five, or more arcs having curvature k, or it can have at least two different interior angles of a convex or concave polygonal structure and may be suitable for the treatment of the jaw, cheeks, submandibular region (e.g., "banana shape 1" 4.2), jawline, perioral region, marionette lines and nasolabial folds (e.g., "banana shape 2" 4.4), periorbital region (e.g., "horseshoe shape" 4.3) or other areas of the face and neck. The "banana-shaped" pads 4.2 or 4.4 may have a convex-concave shape, meaning one side is convex and the other side is concave, which occupies at least 5% to 50%, or 10% to 60%, or 15% to 70%, or 20% to 90% of the entire circumference of the pad 4 as viewed from above, and the shortest distance between the endpoints 4.21a and 4.21b of the "banana-shaped" pad 4.2 (dashed line in Figure 3A) is longer than the shortest distance between the endpoint 4.21a or 4.21b of the "banana-shaped" pad and the midpoint 4.22 (solid line of pad 4.2 in Figure 3A). The horseshoe-shaped pad 4.3, viewed from above, may have an uneven shape that occupies at least 15% to 50%, 20% to 60%, 25% to 70%, or 30% to 90% of its circumference. The shortest distance between the endpoints 4.31a and 4.31b of the horseshoe-shaped pad 4.3 (dashed line in Figure 3B) is equal to or shorter than the shortest distance between the endpoint 4.31a or 4.31b of the horseshoe-shaped pad and the midpoint 4.32 (solid line in pad 4.3 in Figure 3B). When viewed from above, it may be convex or concave, and the longest possible central curve, where the perpendicular line at a given point is equidistant from the periphery of the pad at each of those points (dotted line in pad 4.2 in Figure 3A), intersects the circumference of pad 4, which is the endpoint of the pad, for example, endpoint 4.21a or 4.21b. At that time, the midpoint, for example 4.22, is given as the midpoint of the central curve, and the total length of the central curve is given by the two endpoints, for example 4.21a and 4.21b. Therefore, the length of the central curve from point 4.21a to point 4.22 (the dotted line in pad 4.2 in Figure 3A) is the same as the length from point 4.21b to point 4.22.The total length of the central curve may be in the range of 0.1 to 30 cm, or 0.5 to 25 cm, or 1 to 20 cm.

[0105] In addition, the central curve may have a curve that is at least partially circular, elliptic, parabolic, hyperbolic, exponential, convex, or concave, such that a straight line connecting the endpoint of pad 4 to the midpoint of the central curve forms an angle alpha with the tangent to the midpoint of the central curve. The angle alpha may be in the range of 0.1° to 179°, or 0.2° to 170°, or 0.5° to 160°, or 1° to 150°.

[0106] A pad 4 having a shape with at least two concave arcs having curvature k, or a polygonal structure with at least two concave interior angles, may be suitable for forehead treatment, such as the "T-shape" 4.1 in Figure 3A. The "T-shape" 4.1 may also feature a configuration of active elements 13 in which the centers of at least two active elements 13 are on one straight line and the center of at least one additional element 13 is on a different line.

[0107] The pads range from 0.1 to 150 cm. 2 or 0.2 to 125 cm 2 or 0.5 to 100 cm 2 Within the range of 1 to 50 cm 2 The pads may have different sizes with surface areas in the range of . The pads may occupy about 1 to 99%, or 1 to 80%, or 1 to 60%, or 1 to 50% of the surface. The number of active elements 13 within a single pad 4 is in the range of 1 to 100, or 1 to 80, or 1 to 60, or 1 to 40. The thickness of at least a portion of the pad 4 may be in the range of 0.01 to 15 cm, or 0.02 to 10 cm, or 0.05 to 7 cm, or 0.1 to 7 cm.

[0108] Furthermore, when Pad 4 is attached to the surface of the patient's skin, it will affect the following muscles: galea aponeurotica, procerus, cleft lip, nasal alae, lavator labii superior, zygomaticus minor, zygomaticus major, corner of the mouth, rhomboids, platysma, corner of the mouth, lower lip, occipitofrontalis (frontal belly), currugator supercilii, orbicularis oculi, buccinator, masseter, orbicularis oris, or mentalis. It may have a shape that at least partially replicates the shape of the muscle.

[0109] Pad 4 may be characterized by at least one of the aforementioned embodiments, or by a combination of two or more of the aforementioned embodiments, or by a combination of all of the aforementioned embodiments.

[0110] The electromagnetic energy generator 6 or secondary generator 9 within the main case can generate electromagnetic energy or secondary energy (e.g., electric current), which can be delivered to at least one active element 13 attached to the skin via conductive lead wires. The active element 13 can be supplied with energy through its entire surface or by so-called partial placement. The active element 13 may have an active electrode in a unipolar, bipolar, or multipolar high-frequency system. In a unipolar high-frequency system, energy is supplied between the active electrode (active element 13) and a neutral electrode 7 having a much larger surface area. The distance and difference between the surface areas of the active electrode and the neutral electrode allows energy to concentrate beneath the active electrode, enabling heating of the treatment area. In unipolar, bipolar, or multipolar high-frequency systems, the neutral electrode 7 is not required. In bipolar and multipolar high-frequency systems, energy is delivered between two and more active electrodes, respectively, having similar surface areas. The distance between these electrodes determines the depth of energy penetration. In a unipolar high-frequency system, only a single active electrode is incorporated, and energy is delivered to the tissue and environment surrounding the active electrode. The distance between the two nearest active elements 13 of a single pad 4 (e.g., the nearest adjacent sides of the electrodes) may be in the range of 0.1 to 100 mm, or 0.3 to 70 mm, or 0.5 to 60 mm, or 1 to 50 mm.

[0111] Figure 4 shows a side view of a pad 4 configured for contact therapy. The pad 4 can be made from a flexible substrate material 42 – a polyimide (PI) film, Teflon®, epoxy, or PE foam – with an additional adhesive layer 40 on the underside. They can be in various shapes to allow the operator to select one depending on the area to be treated. The active element 13 is 0.1 to 70 cm². 2 , or 0.5 to 50 cm 2 , or 1 to 25 cm 2 , or 1 to 10 cm 2The pad may have a circular, semicircular, elliptical, oblong, square, rectangular, trapezoidal, or polygonal perimeter with a surface area in the range of . The material used may be copper, aluminum, lead, or any other conductive medium that can be deposited or integrated into the pad. Furthermore, the active element 13 (e.g., electrode) may be made of silver, gold, or graphite. The electrode 13 in the pad 4 may be printed with biocompatible inks such as silver ink, graphite ink, or a combination of inks of different conductive materials.

[0112] The active element 13 (e.g., an electrode that provides a high-frequency electric field and / or electric field) may be a whole-area electrode having a complete active surface. This means that the entire surface of the electrode facing the patient may be made of a conductive material deposited or integrated into the pad 4 as described above.

[0113] Alternatively, the surface of the electrode 13 facing the patient may be formed from a combination of a conductive material (e.g., copper) and a non-conductive material (e.g., dielectric material, insulating material, pad substrate, air, or hydrogel). The electrode 13 may be framed with a conductive material, and the inside of the frame may have a combination of conductive and non-conductive materials. The frame can form the outermost periphery of the electrode from the patient-facing side. The frame may have an annular, semicircular, elliptical, oblong, square, rectangular, trapezoidal, or polygonal shape. The interior of the frame 801 may have a grid structure 802 with a non-conductive portion 803, as shown in Figures 8A and 8B. The frame 801 may have the same thickness as the grid lines 802, or the thickness of the frame 801 may be thicker than the grid lines 802 in the range of 1% to 2000%, 10% to 1000%, 20% to 500%, or 50% to 200%. Furthermore, the frame 801 may be thinner than the grid lines 802 in the range of 0.01 to 20 times, or 0.1 to 10 times, or 0.2 to 5 times, or 0.5 to 2 times. As shown in Figure 8C, it is also possible to design the electrode such that the conductive material of the electrode becomes thinner from the center 804 of the electrode 13. The thinning step between adjacent grid lines 802 in the direction from the center 804 may be in the range of 0.1 to 10 times, 0.2 to 5 times, or 0.5 to 2 times with respect to the frame 801 having the thinnest conductive material line. Alternatively, the electrode may not be framed and may have a grid configuration without boundaries, for example, as shown in Figure 8D. The ratio of conductive material to non-conductive material in the electrode may range from 1% to 99%, or from 5% to 95%, or from 10% to 90%, or from 20% to 80%, or from 30% to 70%, or from 40% to 60%. Furthermore, the ratio of conductive material to non-conductive material in the electrode may 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 grid electrode can be very advantageous.It can be far more flexible, ensure better patient contact, and may have much better self-cooling properties than full-area electrodes.

[0114] If the active element 13 is in the form of a grid electrode, the energy bundle of the grid electrode can be calculated as the energy bundle of the grid 802 and / or flame 801 of the active element 13, which is 0.001 W / cm². 2 From 1500W / cm² 2 Or 0.01 W / cm² 2 From 1000W / cm² 2 Or 0.5 W / cm² 2 From 500W / cm 2 It can be set to the range of

[0115] The active element 13 may be partially embedded in the flexible substrate layer 42 or the adhesive layer 40, or at the interface between the flexible substrate layer 42 and the adhesive layer 40. The active element 13 may be independently supplied and controlled by a plurality of conductive leads 41a, or they may be electrically interconnected and supplied / controlled via a single conductive lead 41b. The plurality of conductive leads 41a are connected to the active element 13 through free space (e.g., holes) within the flexible substrate layer 42. Alternatively, the free space (e.g., a hole) may be sized such that each conductive lead 41a can be firmly fitted into the substrate layer 42, for example, the conductive leads 41a may be encapsulated by the flexible substrate layer 42. In the case of a single conductive lead connection, the active element 13 may be partially embedded inside the flexible substrate 42 or the adhesive layer 40, or at the interface between the flexible substrate layer 42 and the adhesive layer 40, and the active element 13 may be connected via a single conductive lead 41b which may be located inside the flexible substrate 42 or at the interface between the flexible substrate 42 and the adhesive layer 40. The single conductive lead 41b may face outward from the patient and leave a pad 4 on its side or top surface. In either case, the conductive leads 41a or 41b do not come into contact with the treatment area.

[0116] Furthermore, the active element 13 may be partially embedded within the flexible substrate 42, and the adhesive layer 40 may surround the active element 13 such that the surface of the active element 13 can be at least partially in direct contact with the surface of the treatment area.

[0117] The overall pad thickness of the narrower spot can range from 0.1 mm to 60 mm, or from 0.5 mm to 50 mm, or from 0.7 mm to 40 mm, or from 1 mm to 30 mm.

[0118] The device configured in a partial arrangement can have an active element 13 that includes a matrix formed by active points of a defined size. These points are separated by inactive (and thus non - treating) regions that allow for faster tissue healing. The surface including the active points can constitute 1 to 99%, or 2 to 90%, or 3 to 80%, or 4 to 75% of the entire active element area. The active points can have a blunt end on the tissue - contacting side that does not penetrate the tissue, and the surface - contacting tissue can be in the range of 2 from 500 μm 2 to 250000 μm 2 or in the range of 1000 μm 2 to 200000 μm 2 or in the range of 200 μm 2 to 180000 μm 2 or in the range of 5000 μm 2 to 160000 μm and can have a surface area in this range. The blunt end can have a radius of curvature of at least 0.05 mm. The diameter of the surface - contacting tissue of one active point can range from 25 μm to 1500 μm, or from 50 μm to 1000 μm, or from 80 μm to 800 μm, or from 100 μm to 600 μm.

[0119] Furthermore, the device may utilize a safety system comprising a thermal sensor and a circuit that can adjust treatment parameters based on the measured values. Depending on the number and distribution of the active elements 13, one or more thermal sensors may be integrated onto the pad 4 to collect data from different locations to ensure uniform heating. Data may also be collected directly from the treatment area or the active elements 13. If uneven heating or overheating is detected, the device can notify the operator and simultaneously adjust the treatment parameters to avoid burns to the patient. Treatment parameters for one or more active elements can be adjusted. The main treatment parameters are power, duty cycle, and duration, which adjust the switching between multiple active elements 13. If the temperature rises above a safety threshold, treatment may be automatically stopped.

[0120] Furthermore, impedance measurements may be incorporated to monitor the appropriateness of the active element 13 in response to skin contact. If the impedance value is outside the acceptable limits, the treatment may be automatically interrupted, and the operator may be informed of the potential contact problem.

[0121] The CPU 11 may be integrated into the pad 4 itself, or it may form a separate part electrically connected to the pad 4. In addition to the control mechanism, the CPU 11 may also include main indicators (e.g., treatment in progress, actual temperature, and contact between the active element and the skin).

[0122] Figure 5 shows several delivery approaches for devices used in contact therapy.

[0123] It is possible to switch between multiple active elements 13 within a single pad 4 so that multiple active elements 13 deliver energy simultaneously, sequentially, in an overlapping manner, or in any combination thereof. For example, in the case of two active elements, in the simultaneous method, both active elements are used simultaneously during a time interval, e.g., 1 to 20 seconds. In the sequential method, the first active element is used during a first time interval, e.g., from 1 to 10 seconds. The first active element is then stopped, and the second active element is immediately used during a subsequent time interval, e.g., from 10 to 20 seconds. This sequential step may be repeated. In the overlapping method, the first active element is used during a time interval, e.g., from 1 to 10 seconds, and the second active element is used during a second overlapping time interval, e.g., from 1 to 10 seconds, during which the first and second active elements overlap for a total overlapping time, e.g., from 0.1 to 9.9 seconds. The active elements 13 can deliver energy in a predetermined switching sequence or randomly as set by the operator via the human-machine interface 8. Schema I in Figure 5 represents the switching between pairs / groups formed from non-adjacent active elements 13 located within the pad 4. All pairs / groups of active elements 13 deliver energy for a predetermined period (dark gray elements in Figure 5 - elements 1 and 3 in Schema I), while the remaining pairs / groups of active elements 13 remain inactive with respect to energy delivery (light gray elements in Figure 5 - elements 2 and 4 in Schema I). ​​After the predetermined period, energy is supplied by another pair / group of active elements 13, and the initial active elements become inactive. This is indicated by arrows in Figure 5. The switching between pairs / groups of active elements 13 can continue until the target temperature is reached across the entire treatment area, or until a predetermined amount of energy is delivered by all active elements 13. Schema II in Figure 5 represents the switching of all active elements 13 within the pad 4 between the on state, when active elements are supplying energy, and the off state, when active elements are not supplying energy. The duration of the on and off states may vary depending on predetermined settings and / or information provided by sensors, such as thermal sensors.Schema III in Figure 5 illustrates the sequential switching of individual active elements 13 within the pad 4. Each active element 13 delivers energy for a predetermined period until the target temperature is reached across the entire treatment area or until a predetermined energy is delivered by all active elements 13. This sequential switching may be performed in a clockwise or counterclockwise order. Schema IV in Figure 5 preferably represents a zigzag switching sequence in which non-adjacent active elements 13 sequentially deliver energy until all active elements 13 in the pad 4 are turned on. Each active element 13 delivers energy for a predetermined period until the target temperature is reached across the entire treatment area or until a predetermined energy is delivered by all active elements.

[0124] The CPU may be configured to control the stimulating device and administer treatment according to at least one treatment protocol that improves the visual appearance. The treatment protocol is a set of primary and secondary energy parameters that ensure the desired therapeutic effect. Each pad may be controlled to provide the same or alternatively different protocols. Paired areas, or areas where symmetrical effects are desired, can be treated with the same treatment protocol. Each protocol may contain one or more sections or steps.

[0125] As a non-limiting example, when high-frequency energy is applied one by one by active elements, as shown in schemas III and IV of Figure 5, the time it takes for one active element to deliver high-frequency energy to the patient's tissue may range from 1 millisecond to 10 seconds, or from 10 milliseconds to 5 seconds, or from 50 milliseconds to 2 seconds, or from 100 milliseconds to 1500 milliseconds. Two consecutive elements can be switched on and off in a consecutive or overlapping manner. Furthermore, the delivery of high-frequency energy by two consecutive active elements is performed in such a way that neither of the two consecutive active elements causes high-frequency heating of the treatment tissue. The time intervals may be separated by the duration of no high-frequency stimulation or low-frequency stimulation. The durations of no high-frequency stimulation or low-frequency stimulation may range from 1 microsecond to 1000 milliseconds, or from 500 microseconds to 500 milliseconds, or from 1 millisecond to 300 milliseconds, or from 10 milliseconds to 250 milliseconds.

[0126] In treatments using two or more pads, the sequential switching of the active elements delivering high-frequency treatment may be performed within each pad independently of the other pads, or the active elements may sequentially supply energy through all pads.

[0127] As an example of three dependent pads, each has two active elements. First step - The high frequency may be provided by the active element 1 of the first pad, and the other active elements are turned off. Step 2 - Activating element 2 of the first pad is turned on, and the remaining activating elements are turned off. Step 3 - Activation element 1 of the second pad is turned on, and the remaining activation elements are turned off. Step 4 - Activation element 2 of the second pad is turned on, and the remaining activation elements are turned off. Step 5 - Activation element 1 of the third pad is turned on, and the remaining activation elements are turned off. Step 6 - Activator 2 of the third pad is turned on, and the remaining activators are turned off.

[0128] Another non-restrictive example is, First step - The high frequency may be provided by the active element 1 of the first pad, and the other active elements are turned off. Step 2 - Activation element 1 of the second pad is turned on, and the remaining activation elements are turned off. Step 3 - Activating element 1 of the third pad is turned on, and the remaining activating elements are turned off. Step 4 - Activating element 2 of the first pad is turned on, and the remaining activating elements are turned off. Step 5 - Activation element 2 of the second pad is turned on, and the remaining activation elements are turned off. Step 6 - Activator 2 of the third pad is turned on, and the remaining activators are turned off.

[0129] If the pads are treating a pair of areas where a symmetrical effect is desired (e.g., cheeks, thighs, or buttocks), the pair of pads may be driven simultaneously by the same protocol.

[0130] An example of a single-pad treatment protocol for delivering high-frequency energy to heat a patient and current to induce muscle contraction is as follows: The protocol may include a first section in which the electrode of a single pad can be processed so that the electrode supplies a current pulse modulated in an increasing amplitude-modulated envelope (increasing envelope), followed by a constant amplitude (rectangular envelope), and then a decreasing amplitude-modulated envelope (decreasing envelope), and all three of these envelopes together can produce a trapezoidal amplitude-modulated envelope (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 envelope, rectangular envelope, 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 simultaneously, however This generates a symmetrical trapezoidal envelope. Alternatively, the current may be modulated into a sinusoidal envelope, a rectangular envelope, or a triangular envelope. Each envelope that induces muscle contraction may be separated by a period of no current or low current stimulation, or by high-frequency energy that induces tissue heating, so that muscle contraction is not achieved. During this time without muscle contraction, compression massage may be applied by the suction opening, which may induce muscle relaxation. The first section may be pre-programmed so that electrodes at various locations on the pad can be switched in a timely manner to supply AC pulses, while some other electrodes on the pad may supply only RF pulses that induce tissue heating, without supplying any AC pulses. All electrodes on the pad can be ensured to supply (by switching circuit 14 to supply) RF pulses for heating tissue during a section of the protocol or during the protocol, but only a limited number of electrodes may supply (by switching circuit 14 to supply) AC for muscle contraction during a section of the protocol or during the protocol. The device may be configured so that the first section lasts from 1 to 5 minutes.

[0131] The second section may follow the first section. The second section may be pre-programmed to be switched in time to supply alternating current pulses to electrodes at various locations on the pad that are different from those used in the first section, in which some other electrodes on the pad (the same or different from those used in the first section) may supply only RF pulses that cause tissue heating, without supplying any alternating current pulses.

[0132] A third section may follow the second section. The third section may be pre-programmed to be switched in time to supply alternating current pulses to electrodes at various locations on the pad that are different from those used in the second section, in which some other electrodes on the pad (the same or different from those used in the second section) may supply only RF pulses that cause tissue heating, without supplying any alternating current pulses.

[0133] The protocol may be pre-programmed so that the electrodes supplying the current that induces muscle contraction are switched to provide high-frequency heating after generating up to 1, 2, 3, 4, or 5 contractions.

[0134] Each section is assembled by a control unit (CPU) of the treatment protocol, resulting in a single pad producing at least 60 to 900 contractions, 90 to 800 contractions, or 150 to 700 contractions.

[0135] The forehead pad may include an electrode layout such that anatomical regions 1 and 2 are stimulated by alternating current that can induce muscle contraction, while anatomical region 3 is not stimulated by alternating current that can induce muscle contraction. The control unit (CPU) is configured to administer a treatment protocol, as shown in Figure 9, that applies alternating current only to electrodes located near or above anatomical regions 1 and 2, and applies high-frequency signals only to one or more electrodes near or above anatomical region 3. Anatomical regions 1 and 2 may include the frontalis muscle, and anatomical region 3 may include the center of the procerus muscle.

[0136] Pads used for treating the cheeks (below the eyes on both sides of the face) may include an electrode layout such that anatomical areas including the buccinator, masseter, zygomatic muscles, or risorius muscles are stimulated by electric current, potentially causing muscle contractions, while other anatomical areas can be heated only by high-frequency energy.

[0137] Conversely, the pads may be configured such that the electrode layout near the eyes (e.g., body parts including the orbicularis oculi muscle) or teeth (e.g., body parts including the orbicularis oris muscle) does not supply the energy that causes muscle contraction.

[0138] The treatment device may be configured such that, at each part or step, an impedance sensor provides the CPU with information regarding the contact between the pad or active element and the patient. The CPU can determine, based on preset conditions, whether the contact between the pad or active element and the patient is sufficient. If the contact is sufficient, the CPU can continue the treatment protocol. If the contact is inadequate, the evaluated pad or active element is turned off, and the treatment protocol continues until the next pad or active element, or the treatment ends. The determination of appropriate contact of the pad or active element can be displayed on the human-machine interface 8.

[0139] Impedance measurements can be performed at the beginning, during, or at the end of a section / step. Impedance measurements and / or appropriate contact evaluation may be determined only on the active electrode of a given section / step, or on all electrodes of all pads used during the section / step.

[0140] Figures 6 and 7 will be explained together. Figure 6 shows a block diagram of the device 100 for non-contact therapy. Figure 7 is a diagram of the device 100 for non-contact therapy. The device 100 for non-contact therapy may comprise two main blocks, namely a main unit 2 and a delivery head 19 interconnected via a fixed or adjustable arm 21.

[0141] The main unit 2 may include an electromagnetic generator 6 capable of generating one or more forms of electromagnetic radiation, which may be, for example, in the form of incoherent light or coherent light of a predetermined wavelength (e.g., laser light). The electromagnetic field may be primarily generated by a laser, laser diode module, LED, flash lamp, or incandescent light bulb. The electromagnetic radiation may be such that it can be absorbed at least partially beneath the surface of the patient's skin. The wavelength of the radiation applied may be in the range of 100 to 15000 nm, or 200 to 12000 nm, or 300 to 11000 nm, or 400 to 10600 nm, or in the form of wavelengths of the second, third, fourth, fifth, sixth, seventh, or eighth harmonics within the aforementioned wavelength ranges. The main unit 2 may further include a human-machine interface 8, represented by a display, buttons, keyboard, touchpad, touch panel, or other control member, which allows the operator to check and adjust the parameters of the treatment and other devices. The power supply 5 located in the main unit may include a transformer, disposable batteries, rechargeable batteries, a power plug, or a standard power cord. The output power of the power supply 5 may be in the range of 10W to 600W, 50W to 500W, or 80W to 450W. The indicator 17 can independently provide additional information about the current status of the device via the human-machine interface 8. The indicator 17 may be implemented by a display, LEDs, acoustic signals, vibrations, or other forms capable of providing appropriate notification.

[0142] The delivery head 19 may be interconnected with the main unit via an arm 21 that can form the main optical and electrical path. The arm 21 may include a transmission medium for electromagnetic radiation in the form of light or additional electrical signals necessary to power the delivery head 19, such as a wire or waveguide, such as a mirror or optical fiber cable. The CPU 11 is supplied with 0.1 pJ / cm² of electromagnetic radiation from the output of the electromagnetic generator. 2 From 1000 J / cm² 2in the range of, or 0.5 pJ / cm 2 to 800 J / cm 2 in the range of, or 0.8 pJ / cm 2 to 700 J / cm 2 in the range of, or 1 pJ / cm 2 to 600 J / cm 2The electromagnetic generator 6 is controlled, which can generate continuous electromagnetic energy (CM) or pulses having a fluence in the range of . The CM mode can operate at time intervals ranging from 0.1 seconds to 24 hours, or from 0.2 seconds to 12 hours, or from 0.5 seconds to 6 hours, or from 1 second to 3 hours. The pulse duration of electromagnetic radiation operating in the pulsed region may range from 0.1 femtoseconds to 2000 milliseconds, or from 0.5 femtoseconds to 1500 milliseconds, or from 1 femtosecond to 1200 milliseconds, or from 1 femtosecond to 1000 milliseconds. Alternatively, the pulse duration may range from 0.1 femtoseconds to 1000 nanoseconds, or from 0.5 femtoseconds to 800 nanoseconds, or from 1 femtosecond to 500 nanoseconds, or from 1 femtosecond to 300 nanoseconds. Alternatively, the pulse duration may be in the range of 0.3 to 5000 picoseconds, or 1 to 4000 picoseconds, or 5 to 3500 picoseconds, or 10 to 3000 picoseconds. Alternatively, the pulse duration may be in the range of 0.05 to 2000 milliseconds, or 0.1 to 1500 milliseconds, or 0.5 to 1250 milliseconds, or 1 to 1000 milliseconds. The pulsed electromagnetic generator 6 can be operated by the CPU 11 in single-shot mode, repeat mode, or burst mode. The frequency in repeat mode or burst mode may be in the range of 0.05 to 10000 Hz, or 0.1 to 5000 Hz, or 0.3 to 2000 Hz, or 0.5 to 1000 Hz. Alternatively, the frequency of the repeating or burst mode may be in the range of 0.1 kHz to 200 MHz, or 0.5 kHz to 150 MHz, or 0.8 kHz to 100 MHz, or 1 kHz to 80 MHz. The single-shot mode may be configured to generate a single electromagnetic energy of specific parameters (e.g., intensity, duration, etc.) for irradiation of a single treatment area.The repeating mode may be configured to generate electromagnetic energy that may have one or more specific parameters (e.g., intensity, duration, etc.) at a repeating rate of the frequency described above for irradiation of a single treatment area. The burst mode may be configured to generate multiple continuous electromagnetic energies that may have variable parameters (e.g., intensity, duration, delay, etc.) in a single sequence, the sequence being repeated at the frequency described above, and the sequence may contain the same or different sets of continuous electromagnetic energies.

[0143] Alternatively, the device may include two or more electromagnetic generators 6 for generating the same or different electromagnetic energy, for example, one electromagnetic generator for generating excision electromagnetic energy and the other for generating non-excision electromagnetic energy. In this case, the operator can select which electromagnetic generator can be used for a given treatment, or a clinician can select the required treatment via a human-machine interface 8, and the CPU 11 selects which electromagnetic generator to use. One or more electromagnetic generators of device 100 can be operated simultaneously, sequentially, or overlappingly. For example, in the case of two electromagnetic generators, in the simultaneous method, both electromagnetic generators are used simultaneously during a time interval, e.g., 1 to 20 picoseconds. In the sequential method, the first electromagnetic generator is used during a first time interval, e.g., 1 to 10 picoseconds. The first electromagnetic generator is then stopped, and the second electromagnetic generator is immediately used during a subsequent time interval, e.g., 10 to 20 picoseconds. Two or more such consecutive steps may be repeated. In the overlapping method, the first electromagnetic generator is used, for example, during a time interval of 1 to 10 picoseconds, and the second electromagnetic generator is used, for example, during a second overlapping time interval of 2 to 11 picoseconds, and during the second time interval, the first and second electromagnetic generators overlap in a comprehensive overlapping manner, for example, from 2 to 10 picoseconds. In the case of three or more electromagnetic generators, the operation and stopping of the electromagnetic generators in a continuous or overlapping manner may be driven by the CPU 11 in an order suitable for a given treatment, for example, by first operating the preheating electromagnetic generator, then the excision type electromagnetic generator, and then the non-excision type electromagnetic generator.

[0144] The active element 13 of the delivery head 19 may be in the form of an optical element, which may be represented by one or more optical windows, lenses, mirrors, fibers, or diffracting elements. The optical element representing the active element 13 may be connected to or include an electromagnetic generator 6 inside the delivery head 19. The optical element can generate a single beam of electromagnetic energy and provide an energy spot having a size defined as the surface of tissue irradiated by the light of the single beam. A single light generator can provide one or more energy spots, for example, by splitting one beam into multiple beams. The size of the energy spot is 0.001 cm². 2 From 1000cm 2 Within the range of 0.005 cm, or 0.005 cm 2 From 700cm 2 Within the range of 0.01 cm, or 0.01 cm 2 From 300cm 2 Within the range of 0.03 cm, or 0.03 cm 2 From 80cm 2 The range may be such that energy spots of different or the same wavelength are superimposed or separated. Two or more light beams may irradiate the same spot simultaneously or with a time gap ranging from 0.1 microseconds to 30 seconds. The energy spots may be separated by at least 1% of their diameter, and furthermore, the energy spots may closely follow each other or be separated by a gap ranging from 0.01 mm to 20 mm, or from 0.05 mm to 15 mm, or from 0.1 mm to 10 mm.

[0145] The CPU 11 may further be responsible for switching between the active elements 13 or moving the active elements 13 within the delivery head 19 so that electromagnetic radiation can be uniformly delivered across the entire treatment area marked by the targeting beam 18. The switching speed between the active elements 13 may depend on the amount of energy to be delivered, the pulse length, and the speed of the CPU 11 or other mechanisms (e.g., a scanner) responsible for switching or moving the active elements 13. Furthermore, the device may be configured to switch between multiple active elements 13 so that they supply energy simultaneously, sequentially, or overlappingly. For example, in the case of two active elements, in the simultaneous method, both active elements are used simultaneously during a time interval, e.g., 1 to 20 picoseconds. In the sequential method, the first active element is used during a first time interval, e.g., 1 to 10 picoseconds. The first active element is then stopped, and the second active element is immediately used during a subsequent time interval, e.g., 10 to 20 picoseconds. This sequential step may be repeated. In the overlapping method, the first active element is used, for example, during a time interval of 1 to 10 picoseconds, and the second active element is used, for example, during a second overlapping time interval of 2 to 11 picoseconds, during which the first and second active elements overlap for a total overlapping method time of, for example, 2 to 10 picoseconds.

[0146] The targeting beam 18 can function as a tool to mark the area to be treated without clinically affecting the tissue being treated, so that the operator knows exactly which area will be irradiated, and the CPU 11 can set and adjust the treatment parameters accordingly. The targeting beam may be generated by a separate electromagnetic generator or by the primary electromagnetic generator 6. The targeting beam 18 can deliver energy at wavelengths in the range of 300 to 800 nm and can supply energy at a maximum output of 10 mW.

[0147] Furthermore, the pad may include a CPU 11-driven distance sensor 22 for measuring the distance from the active element 13 within the treatment area marked by the aiming beam 18 to the treatment point. The measurement can be used by the CPU 11 as a parameter for adjusting one or more treatment parameters that may depend on the distance between the electromagnetic generator and the treatment point, e.g., fluence. Information from the distance sensor 22 may be provided to the CPU 11 before all switching / movement of the active element 13, thereby ensuring that the energy delivered remains the same across the treatment area, regardless of its shape or non-uniformity.

[0148] The patient's skin may be pre-cooled to a selected temperature over a selected period of time over at least one treatment area, the selected temperature and period for pre-cooling being preferably sufficient to cool the skin to at least a selected temperature lower than normal body temperature. The skin may be cooled to at least a selected temperature to a depth below at least one depth of the treatment area, such that at least one treatment area is substantially surrounded by the cooled skin. Cooling may be continued during the application of radiation, and the duration of radiation application may be longer than the thermal relaxation time of the treatment area. Cooling may be brought about by any known mechanism, including water cooling, spray coolant, the presence of an active solid cooling element (e.g., a thermoelectric cooler), or cooling of airflow. The cooling element may act as an optical element. Alternatively, a spacer may function as a cooling element. Cooling can be performed during, before, or after treatment with electromagnetic energy. Pre-treatment cooling may also provide an environment for rapid thermal shock, while post-treatment cooling may result in faster regeneration after thermal shock. The temperature of the coolant may be in the range of -200°C to 36°C. The temperature of the cooling element during treatment may be in the range of -80°C to 36°C, -70°C to 35°C, or -60°C to 34°C. Furthermore, if the pad is not in contact with the patient's skin, cryogenic spray cooling, gas flow, or other non-contact cooling techniques can be utilized. In addition to, or instead of, one of the above cooling techniques, a cooling gel on the skin surface can also be used.

[0149] Furthermore, device 100 may include one or more sensors. A sensor can provide information about at least one physical quantity, the measured value of which may result in feedback that can be displayed by the human-machine interface 8 or indicator 17. One or more sensors may be used to sense a variety of physical quantities, including but not limited to the energy of delivered or backscattered electromagnetic radiation from the skin, skin impedance, skin resistance, temperature of treated skin, temperature of untreated skin, temperature of at least one layer of skin, water content of the device, phase angle of delivered or reflected energy, position of the active element 13, position of the delivery element 19, temperature of the cooling medium, or temperature of the electromagnetic generator 6. A sensor may be a temperature sensor, acoustic sensor, vibration sensor, electrical sensor, magnetic sensor, flow sensor, position sensor, optical sensor, imaging sensor, pressure sensor, force sensor, energy flux sensor, impedance sensor, current sensor, Hall sensor, or proximity sensor. A sensor may be a capacitive displacement sensor, acoustic proximity sensor, gyroscope, accelerometer, magnetometer, infrared camera, or thermographic camera. A sensor may be invasive or non-contact. The sensor may be located in the delivery element 19 or the main unit 2, or it may be part of the distance sensor 22. A single sensor may measure multiple physical quantities. For example, the sensor may include a combination of a gyroscope, an accelerometer, and / or a magnetometer. Furthermore, the sensor may measure one or more physical quantities of the treated or untreated skin.

[0150] A temperature sensor measures and monitors the temperature of the skin being treated. The temperature can be analyzed by the CPU 11. The temperature sensor may be a non-contact sensor (e.g., an infrared temperature sensor). The CPU 11 can also use an algorithm to calculate the temperature below the skin surface based on the skin surface temperature and one or more additional parameters. The temperature feedback system can control the temperature and warn the operator in a human-perceptible form, for example, through the human-machine interface 8 or indicator 17, based on set or preset limits. Under limit temperature conditions, the device may be configured to adjust the treatment parameters of each active element, such as output power, activate cooling, or stop treatment. The human-perceptible form may be a voice, a warning message, or a change in color of any part of the device 100, shown on the human-machine interface 8 or indicator 17.

[0151] Because resistance sensors can vary from patient to patient, it is possible to measure skin resistance. Humidity—wetting and sweat—can affect the behavior of the skin in the field of resistance, and therefore energy. Based on the measured resistance of the skin, skin impedance can also be calculated.

[0152] Information from one or more sensors can be used to generate a convenient model, for example, a model of the human body displayed on the human-machine interface 8. The path may show the surface or volume of tissue that has already been treated, is currently being treated, is being treated, or is not being treated. The convenient model may show a temperature map of the tissue being treated, while also providing information about the tissue that has already been treated or is not being treated.

[0153] Sensors can provide information about the location of bones, inflamed tissues, or joints. Such types of tissues may not be targeted by electromagnetic radiation because they may involve painful treatments. Bones, joints, or inflamed tissues can be detected by any type of sensor, such as imaging sensors (ultrasonic sensors, IR sensors), impedance sensors, etc. The detected presence of these tissue types can cause interruptions in the generation of general human-perceptible signals or electromagnetic radiation. Bones can be detected, for example, by changes in tissue impedance or by analysis of reflected electromagnetic radiation.

[0154] Furthermore, the device 100 may include an emergency stop button 16 so that the patient can immediately stop treatment at any time during treatment.

[0155] The present invention may be partly defined by a treatment method that includes the following steps: tissue preparation, positioning of the proposed device, selection or setting of treatment parameters, and application of energy. Multiple steps may be performed simultaneously.

[0156] Tissue preparation may include removing makeup or washing the patient's skin. At higher target temperatures, anesthetics may be applied topically or by injection.

[0157] Device positioning may include selecting the correct pad shape depending on the area to be treated, securing the pad or neutral electrode to the patient using, for example, an adhesive layer, vacuum suction, band, or mask, and verifying proper contact with the tissue to be treated in the case of contact therapy. In the case of non-contact therapy, device positioning may include adjusting the aiming beam of the proposed device so that the device can measure the distance of the active element from the treatment area and adjust the treatment parameters accordingly.

[0158] Selecting or setting treatment parameters may include adjusting treatment time, power, duty cycle, delivery time and mode (CM or pulse), partial placement and active point surface density / size for operating modes. Selecting an operating mode may mean selecting simultaneous, continuous or overlapping methods, or selecting the switching sequence of active elements or groups of active elements, or selecting an appropriate pre-programmed protocol.

[0159] The application of energy may include providing at least one type of energy in the form of RF energy, ultrasonic energy or electromagnetic energy in the form of polychromatic or monochromatic light, or a combination thereof. The energy may be delivered into the skin from at least one active element by the proposed device. The energy may be automatically delivered and adjusted by the CPU according to information from temperature sensors and impedance measurements, as well as distance sensors in the case of non-contact therapy. All automatic adjustments and potential effects on the treatment may be displayed on the device's display. Any of the patients may interrupt the treatment at any time during the treatment. A typical treatment may have a duration of approximately 1 to 60 minutes, 2 to 50 minutes, or 3 to 40 minutes per pad, depending on the area being treated and the size and number of active elements located within the pad.

[0160] In one example, the application of energy to tissue may involve supplying radiofrequency energy, ultrasonic energy, or a combination thereof to the patient's skin from an active element embedded in a pad. In such a case, the active element supplying the radiofrequency energy may be a dielectric and capacitive or resistive RF electrode, and the RF energy may cause heating, coagulation, or ablation of the skin. Ultrasonic energy may be supplied through an acoustic window, which can raise the temperature to a depth where gradient loss of RF energy can be suppressed, and thus the desired temperature of the embryonic layer can be reached. Furthermore, the RF electrode can function as an acoustic window for ultrasonic energy.

[0161] Alternatively, the application of energy to the tissue may include supplying electromagnetic energy in the form of polychromatic or monochromatic light from an active element to the patient's skin. In such cases, the active element supplying the electromagnetic energy may include the optical elements described in the proposed device. The optical elements may be represented by optical windows, lenses, mirrors, fibers, or electromagnetic field generators, such as LEDs, lasers, flash lamps, incandescent bulbs, or other light sources known in modern technology. The electromagnetic energy in the form of polychromatic or monochromatic light may be accompanied by heating, coagulation, or ablation of the skin in the area being treated.

[0162] Once the treatment is complete and the required temperature and treatment time have been reached, the device accessories can be removed and the patient's skin can be cleaned.

Claims

1. A device for treating patients, A high-frequency energy generator configured to generate high-frequency energy having a frequency range of 100 kHz to 550 MHz, A current generator configured to generate a pulsed current having a pulse duration in the range of 0.1 microseconds to 10 seconds and a frequency in the range of 0.1 Hz to 12 kHz, wherein the pulsed current is different from the high-frequency energy. Switching circuit, A control unit including a control processing unit or microprocessor configured to control the high-frequency energy generator, the current generator, and the switching circuit, A display configured to allow the user of the device to set the treatment parameters of the device, 0.5 cm ２ From 100cm ２ A flexible pad having a surface area in the range of and configured to be adaptable to the patient's body part, including the face, the subcostal joint of the lower lip, or the neck, A flexible substrate having a lower side configured to face and contact the aforementioned body part of the patient during treatment, A plurality of flexible electrodes are disposed on the underside of the flexible substrate, and each flexible electrode has a surface area of ​​1 cm² ２ 10cm ２ It is within the range, and each flexible electrode is Equipped with a frame and grid wires made of conductive material, The grid lines are separated by a non-conductive material. The frame comprises a plurality of flexible electrodes defining the boundary between the grid lines and the nonconductive material, and A pad including a plurality of conductive leads configured to connect the plurality of flexible electrodes to the high-frequency energy generator and the current generator via the switching circuit, and Displaced below the lower side of the flexible substrate and the plurality of flexible electrodes, and configured to attach the pad to the body portion, the plurality of flexible electrodes are in electrical contact with the body portion via the conductive adhesive layer, including a conductive adhesive layer, The control unit is configured to electrically connect each of the flexible electrodes independently to the high-frequency energy generator and / or the current generator via the switching circuit, and the plurality of flexible electrodes are configured to apply the high-frequency energy and the pulsed current to the body part, thereby the high-frequency energy heating the skin of the body part to a temperature in the range of 38°C to 60°C, and the pulsed current causing muscle contractions within the body part. The device is configured to apply the high-frequency energy and the pulsed current during the treatment.

2. Each of the flexible electrodes is partially embedded in the conductive adhesive layer, The conductive adhesive layer covers the entire surface of the pad. The device according to claim 1, wherein the pad is fixed to the body portion by the conductive adhesive layer.

3. The device according to claim 2, wherein the conductive adhesive layer comprises water or a mixture containing adhesive tape.

4. The device according to claim 3, wherein the impedance of the conductive adhesive layer is higher than the impedance of the skin by a coefficient in the range of 1.1 to 20 times.

5. The pad further comprises a sticker on the upper surface of the flexible substrate. The dimensions of the sticker exceed the edge of the pad by a range of 0.1 cm to 10 cm. The device according to claim 1, wherein the bottom surface of the sticker comprises an adhesive layer configured to provide additional fastening of the pad to the body part of the patient.

6. The pad has a thickness ranging from 0.1 mm to 60 mm. The device according to claim 1, wherein the flexible substrate comprises at least one of a polymer-based material, a silicone-based material, or a fabric.

7. The device according to claim 1, wherein the frame is 0.2 to 5 times thinner than the grid lines.

8. The device according to claim 1, wherein the current generator is configured to generate an alternating current pulse having a rectangular, triangular, sinusoidal, or exponential shape pulse having a pulse duration in the range of 0.5 microseconds to 500 milliseconds and a frequency in the range of 0.1 Hz to 6 kHz.

9. The control unit is configured to generate a trapezoidal envelope by modulating the amplitude of the continuous pulses of the pulsed current. The device according to claim 8, wherein the trapezoidal envelope is a symmetrical trapezoidal envelope having a duration in the range of 1 to 10 seconds.

10. The aforementioned high-frequency energy generator is configured to generate the high-frequency energy with an output power in the range of 10W to 150W. The device according to claim 1, wherein the control unit is configured to control the switching circuit to supply the high-frequency energy in pulses through each of the flexible electrodes with a pulse duration ranging from 0.5 milliseconds to 5 seconds.

11. A device for treating patients, A high-frequency energy generator configured to generate high-frequency energy having a frequency range of 100 kHz to 550 MHz and an output range of 1 W to 200 W. A current generator configured to generate a pulsed current having a pulse duration in the range of 0.1 microseconds to 10 seconds and a frequency in the range of 0.1 Hz to 12 kHz, wherein the pulsed current is different from the high-frequency energy. 0.5 cm ２ From 100cm ２ A flexible pad having a surface area in the range of, configured and attached to conform to a body part of a patient, wherein the body part is at least one selected from the group consisting of the face, the lower lip subproximal, or the neck, The aforementioned flexible pad is 0.002 mm －１ 10mm －１ Having one or more convex or concave polygonal shapes with curvatures k within the range of a circular arc, A flexible substrate having a lower side configured to face and contact the face, the lower lip subcosum, or the neck, A plurality of flexible electrodes including a first flexible electrode, wherein the plurality of flexible electrodes are disposed on the lower side of the flexible substrate and have a surface area ranging from 1 cm ２ to 10 cm ２ in the range of, Equipped with a frame and grid wires made of conductive material, The grid lines are separated by a non-conductive material. The frame comprises a plurality of flexible electrodes defining the boundary between the grid lines and the nonconductive material, and A flexible pad, including a first conductive lead configured to connect the first flexible electrode to the high-frequency energy generator and the current generator, and Includes an adhesive layer disposed below the lower side of the flexible substrate and the plurality of flexible electrodes, The plurality of flexible electrodes electrically contact the face, the lower lip subproximal ridge, or the neck via the adhesive layer during treatment. Each of the aforementioned flexible electrodes is electrically connected independently to the high-frequency energy generator and / or the current generator. The first flexible electrode is configured to alternately apply the high-frequency energy and the pulsed current to the body portion. As a result, the high-frequency energy heats the skin of each body part to a range of 38°C to 60°C, and the pulsed current causes muscle contraction within the same body part. The device is configured to apply the high-frequency energy and the pulsed current for the treatment of the patient.

12. The surface area of ​​the flexible pad is 1 cm². ２ 50cm ２ The device according to claim 1, which is within the range of.

13. The plurality of flexible electrodes comprises a second flexible electrode positioned below the flexible substrate and configured to supply the high-frequency energy to the face, the lower lip subproximal segment, or the neck to cause the high-frequency heating of the face, the lower lip subproximal segment, or the neck, The device according to claim 11, wherein the distance between the first flexible electrode and the second flexible electrode is in the range of 1 mm to 50 mm.

14. The aforementioned flexible pad is configured for the treatment of the forehead, The device according to claim 13, wherein the first flexible electrode and the second flexible electrode are arranged on the flexible pad such that when the flexible pad is attached to the forehead, the first flexible electrode is configured to induce contraction of the frontalis muscle and the second flexible electrode is configured to supply heat to the procerus muscle.

15. The flexible pad is configured for the treatment of the left or right cheek, The device according to claim 13, wherein the first flexible electrode is configured to induce contraction of at least one of the buccinator muscle, masseter muscle, zygomatic muscle, or risorius muscle.

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