Systems for subcutaneous treatments

[0001] The field of the invention is non-invasive, non-traumatic, focused remodeling and reduction of fat cells in the subcutaneous tissue, body shaping and skin tightening.

BACKGROUND OF THE INVENTION [0002] Human skin consists of three main parts: epidermis, dermis and hypoderma or so-called subcutaneous tissue. The dermis is made of collagen elastic tissue and reticulin fibers. The subcutaneous tissue is the deepest layer of skin and contains hair follicles, lymphatic vessels, collagen tissue, nerve fibers, as well as subcutaneous fat that forms adipose tissue. Adipose tissue is formed by the aggregation of fat cells containing stored lipid (fat). Most of the accumulated fat comes mainly from lipids (fats) from food, when the energy value from the food exceeds the daily energy requirement. This can result in an increase in fat cells or the number of fat cells, or both. Mature fat cells are not very large, their size ranges up to 120 microns in diameter and they contain up to 95% of the lipid (fat) volume. In people with a slim or moderate figure, the subcutaneous fat layer may be thin (about 1 cm or less).

[0003] Excess body fat can be seen as aesthetically undesirable. Diet and exercise can result in reduced body fat and weight. However, for most people, the reduction in body fat occurs quite unpredictably in various anatomical areas. Thus, even significant weight loss may not affect the areas desired to decrease, for example the abdomen. Many invasive and non-invasive methods have been developed to remove unwanted subcutaneous fat from specific areas of the body.

[0004] Invasive methods such as liposuction and lipolysis can be painful and traumatic, with many undesirable side effects and risks. Non-invasive methods focus on accelerating lipolysis as a natural process of reducing body fat. This can be achieved in many ways. One of them is the use of pharmaceuticals that accelerate lipolysis. However, when applied topically, they usually affect only the outermost layers of the skin, rarely penetrating the deep vascular plexus. Another method uses radio frequency or ultrasonic energy focused on adipose tissue to cause cell destruction and death. These methods can lead to damage to melanocytes in the epidermis. Hyperthermic temperatures destroy target tissue and allow the body to remove dead cells and other residues. Non-invasive heating methods are also used. They include heating fat to around 40 ° C or more by direct contact with the heating element. These non-invasive methods also have some disadvantages and are used with varying degrees of effectiveness.

[0005] Patent application EP-A1-1158919 discloses a system for treating a patient's subcutaneous fat comprising capacitive electrodes for use on the skin.

[0006] Accordingly, there is a need for improved subcutaneous therapy systems.

VP / 5135 / AG

EP 2 780 080 B1

SUMMARY OF THE INVENTION [0007] The invention relates to a system as defined in the appended claims and can be used in a method of treating subcutaneous tissue as described in the following sections. The method of treating subcutaneous tissue includes placing one or more applicators adjacent to the patient's skin but not touching the skin. Electromagnetic energy is transmitted from the applicators to the subcutaneous tissue. The subcutaneous tissue is heated by electromagnetic energy. The subcutaneous tissue may be remodeled. The volume of fat cells in the subcutaneous tissue can be reduced by heating. Electromagnetic waves can be used in pulse mode or in continuous mode. Optionally, the skin can be actively cooled without touching the skin. This method can also be used to tighten the skin and model collagen tissue in the subcutaneous tissue. Since the applicator does not touch the skin, there is no need to cool the skin or take into account biocompatibility factors.

[0008] Another method of treating subcutaneous tissue involves using one or more applicators without constantly moving the applicator. One or more applicators can be mounted on a tripod or holder instead of being held in your hand. Exclusive and continuous therapy supervision by a qualified system user may not be necessary.

BRIEF DESCRIPTION OF THE FIGURES [0009]

Fig. 1 is a pictorial diagram of a system for controlled deep heating of subcutaneous tissues;

Fig. 2 is a schematic view of the inter-area path of the electromagnetic field;

Figures 3 and 4 are schematic examples of placement of the electrodes shown in Fig. 1.

DETAILED DESCRIPTION [0010] Prior art methods usually require direct contact of the applicator with the skin. This, in turn, usually also requires the use of elements that actively cool the skin. Direct skin contact can also involve consideration of the applicability of the applicator material and also require strict sanitary standards because applicators are used to treat different patients. The operator must also be trained to use applicators as there is a risk of patient burns. In prior art methods, the operator must also move the applicator continuously to reduce the risk of patient burns.

[0011] These disadvantages are overcome by transmitting electromagnetic energy to the subcutaneous tissue without physical contact with the patient. Methods of therapy that avoid contact of the applicator with the skin allow simultaneous therapy of a larger area of ​​the human body. It also eliminates the need for artificial skin cooling. In these non-contact methods, the skin can be sufficiently cooled passively by the ambient air. Optionally, the skin can be cooled by a stream of chilled air or at room temperature. These methods also do not require the use of cooling liquids or gels. This reduces costs and increases patient comfort.

[0012] In one aspect, the present methods employ the principle of the selective, deep heating of human tissue with a low water content, such as adipose tissue. Radiant energy can be delivered to the subcutaneous tissue through one or more electrodes

VP / 5135 / AG

EP 2 780 080 B1 capacitive, generating an electromagnetic field. Selective heating in the dermis occurs through dielectric losses.

[0013] In continuous operation, the electromagnetic field is applied continuously, which ensures the maximum heating value. Using pulse mode, the heat is local and usually limited to about 400 W. In pulse mode, a high frequency field is applied at short intervals (usually 50-2000 μs) and with different pulse frequencies (usually from 50 to 1500 Hz). The maximum continuous output power is usually limited to 200 W.

[0014] The increase in temperature in skin and subcutaneous tissues also affects the triple spiral structure of collagen fibers contained in such tissues. This can result in collagen remodeling and rejuvenation, increase skin density and skin thickness, thanks to neocollagenesis. Skin tightening can also be achieved.

[0015] Remodeling and reducing the volume of subcutaneous fat cells and tightening the skin in target areas can change the overall appearance of the body, for the purpose of body shaping and body shape changes.

[0016] Electromagnetic energy is supplied through the skin to the underlying subcutaneous tissue without touching the skin. Radiant energy is transformed into heat in the subcutaneous tissue. Radiant energy enables focused heating of subcutaneous fat and subcutaneous collagen tissue, leading to accelerated lipolysis. At the same time, the heating of the triple spiral structure of collagen fibers can cause rebuilding and / or rejuvenation of collagen, increasing skin density and skin thickness due to neocollagenesis. Subcutaneous fat cells can be remodeled and / or reduced by modeling and tightening the skin.

[0017] Another method allows therapy without the need to constantly move the applicator. The step of repeatedly moving the applicator according to a set pattern above the patient's skin is omitted. With the applicator applying heat over a larger area, continuous movement of the applicator is not necessary. The applicator may remain in a stationary position relative to the patient for a few seconds or longer, for example for at least 5, 10, 30, 60, 120 or 240 seconds or longer. Non-contact methods also allow simultaneous therapy of a larger area of ​​the human body. It also eliminates the need for artificial skin cooling. In the present methods, where the applicator does not touch the skin, the skin can be sufficiently cooled passively by circulating air. Optionally, the skin can be cooled by a stream of chilled air or at room temperature. These methods also do not require the use of cooling liquids or gels. This reduces costs and increases patient comfort.

[0018] Referring to Fig. 1, system 16 applies electromagnetic energy through a skin layer, such as the epidermis, to the underlying subcutaneous tissue and collagen tissue, resulting in accelerated lipolysis and collagen remodeling. The system can contain 6 blocks. The power supply system 10 is connected to a power source. HF generator (high frequency generator high frequency) 11, generator and matching system control unit 14 and a microprocessor control unit with a user interface are connected to the supply system 10. The HF 11 generator can generate an electromagnetic field with a frequency of 13.56 or 40.68 or 27.12 MHz or 2.45 GHz or optionally also with a different frequency. Frequencies 13.56; 27.12 and 40.68 MHz and 2.45 GHz do not cause radio interference because they are only allocated as free or open frequencies.

VP / 5135 / AG

[0019] The microprocessor control unit 15 with the user interface provides communication between the matching unit control unit 14 and the generator and the user interface, which may be a touch screen in the display device.

[0020] The control unit 14 of the matching system and generator receives information from the user via the control unit and regulates the operation of the HF generator 11 and the matching system 12. The matching system sends the HF to the symmetrical transformer 13, which converts asymmetrical impedance to symmetrical impedance. The processed signal runs to two capacitive applicators 6, which can be placed approximately 2-3 cm above the surface of the skin.

[0021] Fig. 2 is a schematic representation of the heat distribution under the skin. One or more applicators 6 create an electromagnetic field. This electromagnetic field cuts the air gap 25 between the applicator and the patient's skin and penetrates the skin 2, subcutaneous fat 3, muscles 4 and bones 5. Capacitive applicators 6 provide deep heating, which selectively heats only structures with low water content. Separator 7, such as towel, gauze, foam mat, fabric, etc. can be placed on the skin with the applicator placed on the separator 7. This automatically sets the separation distance between the applicator and skin and prevents the applicator from coming into contact with the skin.

[0022] If used, the separator 7 may be made of various dielectric and non-electrically conductive materials. Separator 7 is usually used dry. Alternatively, the disposable or reusable separator may be attached to the applicator. For example, the separator may include posts, a frame or other structure on the applicator that contacts the skin while keeping the applicator active surface away from the skin. As described and claimed herein, such separating elements are additional elements and do not form part of the applicator. The methods can be performed without any applicator parts or surfaces, including any connection on the applicator, touching the skin.

[0023] The selective heating process takes place in the dermis 3 as a result of dielectric losses. Dielectric losses arise when part of the power of an AC electromagnetic field is converted to heat in a dielectric. During this process, polar molecules rotate and their movement produces thermal energy. The electric field 1 does not affect the skin and muscles to a greater extent because it contains water and the circulating blood ensures cooling. The bones 5 heat up slightly because the applicators 6 are positioned to produce a field only in the upper structures. Fat cells of adipose tissue contain less water than the surrounding tissue, and therefore heat up more than the surrounding tissue.

[0024] Figures 3 and 4 are schematic examples of placement of applicators or electrodes 6 supplying radiant energy through the skin 2 to the subcutaneous fat 3. The electrodes are placed approximately 2-3 cm above the surface of the skin or placed on a separator 7 that contacts the surface of the skin, as shown in Fig. 5. Separator 7, if used, may have a thickness of typically 0.5 to 1 cm, respectively. The applicator 6 can be temporarily immobilized in relation to the patient, if necessary, for example on a mechanical tripod or handle.

[0025] In each case, it is not necessary to constantly move the applicator during the procedure. This makes the procedure easier because the user does not have to constantly move the applicator over the patient's skin. As a result, the user can respectively simultaneously

VP / 5135 / AG

EP 2 780 080 B1 to supervise the needs of other patients. The applicator 6 may have a relatively large surface area such that the distribution of field 1 is wider in the subcutaneous tissue. For example, the applicator may have a surface area₂ equal to at least about 10, 15, 30, 50, 100 or 150 cm².

[0026] When more than one applicator is used, the applicators may be located on opposite sides of the patient. The separator can be placed between one or more applicators and the patient's skin.

[0027] The methods may include one or more of the following steps: placing a separator or providing an air gap between the applicator and the patient's skin; transmission of electromagnetic energy in the range 13.553-13.567 or 26.957-27.83 or 40.66-40.70 MHz or 2.4-2.5 GHz from the applicator to the subcutaneous tissue; and placing or holding the applicator stationary relative to the tissue for at least 10 seconds; optionally with an applicator not touching the patient's skin. When two or more applicators are used, the applicators may be placed on opposite sides of the patient. The applicator can be two or more capacitive electrodes.

[0028] Electromagnetic waves may be applied in a continuous mode or in a pulsed mode with a power range of, e.g. 30-400 W per pulse.

VP / 5135 / AG

EP 2 780 080 B1