KR20130128391A - Method and device for soft tissue treatment - Google Patents

Abstract

A method and system for non-invasive cosmetic treatment of soft tissues such as adipose tissue, muscle tissue or connective tissue. The device includes an applicator configured to apply a positive and negative pressure phase to the skin surface relative to ambient pressure. The positive pressure phase is considerably longer than the negative pressure phase and the negative pressure phase directly follows the positive pressure phase.

Description

METHOD AND DEVICE FOR SOFT TISSUE TREATMENT}

The methods and devices of the present invention relate to cosmetic devices and more particularly to devices and methods for non-invasive treatment of soft tissues such as adipose tissue.

Adipose tissue is located below the skin layer. Therefore, the energy applied to the skin surface must pass through the skin and reach the adipose tissue in order to break down the adipose tissue.

Various devices have been used for the treatment of adipose tissue, the partial removal of which is known as "circumference reduction". One popular method of treating adipose tissue is liposuction. This is a surgical technique involving mechanical destruction of fat followed by a subsequent procedure of inhaling the resulting debris from the body. The main disadvantage of this method is its invasive nature.

There are methods for treating adipose tissue based on thermal destruction of fat by exposing the adipose tissue to focused microwaves or ultrasound. The intensity and focus of the energy is determined to selectively destroy fat cells without damaging skin or deep tissues. In some cases, high intensity focused ultrasound (HIFU) is used to destroy adipose tissue. HIFU is applied in pulses to create cavitation that destroys fat cells.

It is known to use an applicator with a vacuum chamber to pull segments of skin into the chamber and to apply various energy treatments to it. Such applicators usually include a rigid plate or flexible membrane, or a combination of a rigid plate and a flexible membrane located inside the chamber. The plate or membrane is forced to move quickly away from the surface of the skin within the chamber in order to create a negative pressure on the portion inside the chamber between the skin and the plate surface.

Movement of the plate or membrane sucks the skin outward from the subject body, where RF voltage is usually applied to the skin, for example. Moving the skin outward into the chamber from the subject's body stretches the skin and increases the pressure on the skin at the edges or corners of the chamber rim. This kidney pressure often results in unpleasant and painful sensations in the person being treated.

Movement of the plate or membrane and movement of the skin into the chamber are limited because the trapped air of the pockets remains in the chamber and the air pressure in the pocket increases when the plate or membrane, which actually acts as a piston, moves up.

The present invention is a method and apparatus for the treatment of soft tissues such as adipose tissue, muscle tissue or connective tissue. In the method and apparatus, a pressure pulse is applied to the skin region above the volume of soft tissue. The pressure pulse has one or more positive and one musical phases relative to ambient pressure. The positive pressure phase is considerably longer than the negative pressure phase. The positive phase period is sufficient to ensure synchronous migration between the soft tissue itself or the skin surface above the soft tissue volume or adipose tissue volume. The pressure change during the positive pressure phase is considerably slower than the pressure change during the negative pressure phase. The positive phase phase displaces or pushes all of the skin layers, including adipose tissue, into the body to be treated. Negative pressure quickly pulls or bends the tissue being treated out of the body.

In the case of adipose tissue, the action of negative pressure results in the destruction of fat cells with little or no damage to other tissues, since the fat tissue or fat cells are larger and weaker than other cells. The intensity and time of the pressure pulse is selected to cause maximum destruction of adipocytes with minimal damage to other tissues. In the case of other types of soft tissues such as muscle tissue or connective tissue, the pulses cause tissue massage effects.

In one embodiment of the device of the invention, the positive pressure phase is created by a mechanical gear that slowly pushes a rod with a piston or plate into the body to be treated. When the desired skin and tissue tension is reached, the gears unload and the spring quickly relaxes the rod, creating a negative pressure phase relative to ambient pressure.

In the course of slow positive pressure application during such applicator operation, the skin exhibits maximum migration and minimal skin elongation. The adipose tissue layer follows the deflection or deflection of the outer skin layer and actually moves with the movement of the outer skin layer. Because skin elongation does not occur when the skin is bent or displaced out of the subject's body, the treated subject will not feel pain or other unpleasant sensations. Another embodiment of the device of the present invention is based on an actuator that creates a push-pull (positive-negative pressure) action by controlling the application or removal of a pressure pulse of a gas such as air inside the actuator.

In the case of the treatment of adipose tissue, the temperature of the adipose tissue can be raised during treatment to enhance the effect of cell destruction by pressure pulses. Prior to and / or concurrent with the application of the pressure pulse, the adipose tissue is typically heated to a temperature that is not high enough to damage the skin surface but equal to or above normal body tissue temperature (37 ° C.). Fats such as flowing RF current through tissue through conducting electrodes on the surface of the skin, irradiating the skin surface with the light of a flash lamp or laser, or radiating microwave power or high intensity ultrasound inside the tissue. Any known method for heating tissue can be used. The applicator may be configured to apply heat to the tissue volume being treated, which heat is typically applied at a predetermined depth below the skin surface.

In another embodiment, an applicator is disclosed having a valve that opens in the course of a push to release air that can be trapped between the skin and the piston so that the piston can make firm contact with the skin.

In order to understand the present invention and to actually see how it is practiced, numerous embodiments will be described with reference to the following figures by way of illustration only.
1 illustrates an embodiment of a system for applying a positive pressure and negative pressure phase to a skin surface in accordance with one embodiment of the method and apparatus of the present invention;
2A-2C illustrate the principle of operation of one embodiment of an applicator suitable for applying a positive and negative pressure phase that reduced pain for a subject to be treated;
3 briefly illustrates an embodiment of the positive and negative pressure phases generated in accordance with the method of the present invention,
4A-4D briefly illustrate the principle of operation of another embodiment of an applicator suitable for generating positive and negative pressure phases in accordance with the method of the present invention;
5 briefly illustrates another embodiment of an applicator suitable for generating positive and negative pressure phases in accordance with the method of the present invention;
6 briefly illustrates a further embodiment of the RF electrode configuration.

1 shows an embodiment of a device for treating soft body tissues, such as adipose tissue, in accordance with one embodiment of the device of the present invention. The applicator 100 described in detail below is adapted to be applied to the skin of the subject 104 during operation. The applicator 100 is connected to the control unit 106 via the wires of the cable 102. The control unit 106 also includes a temperature control unit 112 that cools the fluid, such as ethanol or water, to maintain the applicator 100 at the predetermined temperature described below. The control unit 106 is provided with an input device such as the keypad 110 to allow the operator to input selected values of treatment parameters, such as intensity and duration of positive and negative pressure phases and pulse or phase repetition rates.

2A-2C illustrate the principle of operation of one embodiment of an applicator suitable for generating positive and negative pressure phases to reduce or eliminate pain in a subject being treated. 2A shows an initial state, in which the applicator 200 has a chamber 228 having a rim 250 against the skin surface 204 in such a way that the rim 250 contacts the skin surface over adipose tissue. ) At least. The piston 208 is a rigid body that moves in the chamber 228. The piston 208 has a curved convex surface that contacts the skin surface 204 when the applicator 200 is against the skin surface 204. When a positive pressure phase (see FIG. 2B) is applied to the applicator relative to the periphery, the piston or actuator plate 208 pushes the skin layer 212 into the subject's body to the skin layer 212 and the underlying adipose tissue 216. Produces a positive pressure. Skin 212 and adipose tissue 216 follow the convex contour of the piston. During the slow push operation, the skin will follow the piston contour without tension and pain while the adipose tissue will flow out of the treatment zone under pressure as indicated by arrow 220, and the thinner adipose tissue below the actuator plate 208. Convex layers will remain. The valve 244 will open in the course of a push phase where air trapped between the skin 204 and the piston is discharged to push the piston into tight contact with the skin.

When the actuator plate 208 is displaced out of the subject's body as indicated by the arrow 224, the skin layer 212 is drawn into the chamber 228 of the applicator 200 to create a negative pressure in the chamber 228. Pulled to form protrusions 232. The action of pulling the skin into the chamber 228 does not extend the skin segment located on the rim 250 of the chamber 228 and, even though the pull operation is very fast, the skin bending into the chamber is only bent and not stretched. In addition, pain may be alleviated or prevented for the subject being treated. One or more one-way valves 244 can be used to prevent the occasional increase in pressure in the air pocket 240. During the pull phase, these valves are closed, so that a vacuum is formed to attract the skin. The intensity and time profile of the pressure pulse can be selected to cause maximum damage to adipose tissue while minimal damage to other tissues. The pushing phase is 0.1 to 10 seconds long and the pulling phase is 0.1 to 100 milliseconds or 0.1 to 10 milliseconds long. The applicator 200 may have an opening 254 in communication with the ambient atmosphere to prevent an increase in pressure in the chamber 228 during formation of the protrusion 232. The control unit 106 (FIG. 1) controls and operates the applicator 200.

The inventors of the method and apparatus of the present invention experimentally found that when the magnitude of the force applied to the skin slowly changes during the course of the negative pressure phase, rather, the adipose tissue acting close to the fluid easily follows the skin or moves almost simultaneously with the skin. Proved.

Since the force required to slowly push the skin and fat is so small, the pressure gradient formed is small. When the transition to the negative pressure phase is rapid, the pulling force on the adipose tissue is significantly greater. Basically, this can be explained by Newton's second law, which means that faster object motion means greater acceleration and can be generated by the application of greater force. These pulling forces create negative pressure in the deeper fat layers. In fact, this pulling force and sound pressure last as long as the skin and adipose tissue accelerate outwards. Under the skin-like layer of supple, unextended upper, fluid pressures up to -1 Bar at depths of 5 mm, sound pressures of about -0.7 Bar at depths of 10 mm and sound pressures of -0.4 Bar at depths of 15 mm It has been experimentally confirmed that it can occur inside adipose tissue that behaves as follows. Negative and positive pressure phases have a period and amplitude selected to cause maximum destruction of fat cells and minimal damage to other tissues.

Those skilled in the art will appreciate that other applicators may also be suitable for generating a positive and negative pressure phase in which pain for the subject being treated is reduced or eliminated. Such applicators may include an applicator having a magnetic solenoid actuator or an applicator that generates sparks in the liquid to generate positive and negative pressure pulses, both of which are disclosed in US Pat. No. 7,857,775 and The contents are incorporated herein by reference. Other actuators may also include positive and negative pressure actuators such as compressed gas actuators, motor actuators, and spring actuators.

3, which schematically shows an embodiment of the positive and negative pressure phases generated in accordance with the method of the present invention, according to the present invention, the "pushing" phase or positive pressure phase has a significantly longer period than the negative pressure phase period. . The positive pressure phase period is sufficient to ensure skin-fat tissue joint movement of the outer skin layer 212 and the adipose tissue layer 216. For example, positive pressure phase 304 may be between 0.1 and 10 seconds. Such slow motion or displacement of the skin and adipose tissue layers ensures joint movement between the outer skin layer 212 and the adipose tissue 216 over the adipose tissue layer. The pressure applied to skin layer 212 during the positive pressure phase also changes significantly slower than the pressure change during the negative pressure phase. Negative pressure phase 308 immediately follows positive pressure phase 304. The duration of the sound pressure 308 is extremely short and can be between 0.1 ms and 10 ms. During this rapid phase of negative pressure, both the skin and the adipose tissue layers are accelerated to move outwardly; High levels of acceleration are generated by high speed motion, and according to Newton's second law, this acceleration creates a force on the tissue layers that creates a large peak of negative pressure in the subcutaneous tissue.

An illumination source, which may be included in the RF electrode or the ultrasonic transducer, or the applicator, may be used to apply therapeutic energy to a meaningful portion of the adipose tissue 216 to result in the desired heating to enhance the effect of negative pressure on the tissue. Can be. The tissue is heated above its normal temperature to enhance the effect of negative pressure on the adipose tissue. The outer skin layer is commonly known to have a temperature of about 30-33 ° C. The temperature usually rises from the outer skin layer to the inner skin layer, in particular to a layer of adipose tissue located between the skin and the muscles. Because of this temperature hardness, the significant volume of fat is below 36.6 ° C. The inventors of the present invention have experimentally confirmed that the fat cell destruction by the negative pressure pulse is promoted when the fat is heated to 37 ℃ or more.

4 schematically illustrates a typical applicator suitable for generating positive and negative pressure phases in accordance with the method of the present invention. Applicator 400 (FIG. 4A) includes rod 408 to which actuator 404 and flexible plate or membrane 412 are attached. Electrode 416 may also be attached to rod 408 or coupled to a membrane. Actuator 404 may be a worm gear driven by a rack and pinion mechanism or a DC (direct current) motor. Alternatively, the actuator 404 can be driven by a stepper motor with a suitable gear.

The actuator 404 applies a positive pressure to the skin and slowly pushes the skin into the subject to be treated at a rate that ensures co-movement between the soft or fat tissue layer 216 and the outer skin layer 212 (FIG. 4B) during the procedure. For example, the deflection or sag of the skin 212 may be between 5 mm and 20 mm, depending on the size of the skin segment and applicator being treated and the positive pressure phase period will be between 0.1 and 10 seconds. Can be. In the course of skin displacement, the rod 408 tensions the spring 420 (FIG. 4A) and a ratchet-and-pawl type mechanism 424 or simply a pin when the desired displacement size is reached. ) Moves into the position indicated by arrow 428 and secures rod 408 at the position where maximum pressure is applied to the skin. Applicator 400 may have an opening 444 in communication with the ambient atmosphere to prevent an increase in pressure in chamber 428 during formation of protrusion 432 (FIG. 4C).

The advantage of such an applicator procedure is that the skin shows maximum movement and minimal skin elongation during slow positive pressure application. The adipose tissue layer 216 has sufficient time to follow the displacement or curvature of the outer skin layer 212 and in practice moves jointly with the outer skin layer movement.

After reaching this condition, the ratchet device 424 can be released and the spring 420 releases the rod 408, membrane 412 (FIG. 4A) and the skin, which move up with high acceleration, creating a negative pressure phase. . The duration of the sound pressure phase may be between 0.1 ms and 10 ms. Soft tissues, in particular adipose tissue, are at high acceleration during this high speed movement, thus creating a negative pressure deep inside the tissue and generating a force to destroy it, destroying the adipose tissue cells; And because the skin has already been displaced or flexed during the positive pressure phase into the subject's body; The curved skin segment during the negative pressure phase process simply bends outwardly of the subject body to become the protrusion 432. Because the skin elongation does not occur when the skin is bent or displaced out of the subject's body, the treated subject does not feel pain or other discomfort.

RF voltage source 108 (FIG. 1) applies RF voltage to protruding skin 212 and adipose tissue 216 through electrode 416 and circular electrode 440 (FIG. 4D). The current induced by the applied RF voltage shown by dashed line 450 (FIG. 4D) affects almost all of the adipose tissue 216 located within the protrusion 432. The control unit 106 (FIG. 1) controls and operates the applicator 400.

The upward movement of the membrane 412 and the rod 408 may be limited by including a simple photoelectric protrusion sensor 460 or mechanical stop in the applicator, further minimizing the risk of skin elongation. The positive and negative pressure phases can be repeated until the desired therapeutic effect is achieved.

5 schematically illustrates an embodiment of another applicator suitable for generating a positive and negative pressure phase in accordance with the method of the present invention. Applicator 500 includes a rod 408 to which actuator 404 and a flexible plate or membrane 512 are attached. Electrode 516 may also be attached to rod 408 or coupled to membrane 512. Membrane 512 may be inserted into a soft hinge type circular channel 544 that is easily bent as indicated by arrow 548. The stiffness of the circular channel 544 may be lower than the stiffness of the membrane 512. This allows for more flexible, larger and higher protrusion formation. In addition, the operation of the applicator actuator 404 is similar to that of the applicator 404 disclosed in connection with FIG. 4.

6 shows a further embodiment of the RF electrode configuration. RF voltage source 436 applies an RF voltage between at least one pair of oppositely disposed electrodes 540 that are segments of the circle. RF voltage is applied to the skin and adipose tissue that are sucked into the protrusions. The current induced by the applied RF voltage affects almost all of the adipose tissue located within the protrusions. In further embodiments, the RF voltage may be applied alternately between a pair of oppositely disposed electrodes 540 or between at least one of the electrodes 540 and the center electrode 516.

According to another embodiment, a worm gear driven by the rack-pinion device or a DC (direct current) motor or by a stepper motor with a suitable gear operates as an actuator and moves the piston 208 (FIG. 2). And move slowly into the subject's body at a rate that ensures joint movement between the outer skin layer 212 (FIG. 4B) and the soft or fat tissue layer 216. When the piston 228 reaches the proper depth (and the appropriate pressure) into the body to be treated, the ratchet device 424 (FIG. 4) is released and the spring 420 prevents the piston 208 from moving upward with high acceleration. To generate a negative pressure phase.

Optionally, the applicators 400 and 500 may include one or more light sources that illuminate the protrusions by one or more wavelengths to heat the adipose tissue in the protrusions 432. In further embodiments, applicators 400 and 500 may include two or more energy sources that act on tissue temperature. For example, an ultrasonic energy source can be included in any of the applicators.

The repetition rate of the negative and positive pressure phases can be slow, typically from 10 to 0.1 cycles / second. The slow movement of the skin into the body caused by the positive pressure phase and the positive pressure phase immediately following the application of the sudden negative pressure phase are more useful for the destruction of fat cells, and damage to other tissues than the application of the high-speed positive pressure and negative pressure phase is more likely. Few or few

The method and apparatus of the present invention allow for better fat tissue destruction and circumference reduction. There is no pretreatment or post-treatment of the skin, which increases the comfort of the subject being treated. The skin segment located on the rim of the chamber of the applicator may not be stretched to alleviate or prevent pain in the subject being treated.

While embodiments of apparatus and methods for adipose tissue destruction have been presented so far, it will be appreciated that various changes may be made without affecting the spirit and scope of the apparatus and methods of the present invention. Therefore, the scope of the method and apparatus of the present invention is defined based on the claims of the following claims.

Claims (41)

In the non-invasive method of treating adipose tissue volume,
At least one positive pressure phase relative to the periphery by pushing the skin over the adipose tissue into the subject body; And
Pulling the skin over the adipose tissue volume outward of the subject body to generate one or more negative pressure phases in the adipose tissue relative to the periphery,
The negative pressure phase immediately follows the positive pressure phase;
A non-fatty tissue that bends the skin inwards during the positive pressure phase and quickly bends outward from the subject's body without elongating the skin during the negative pressure phase, thereby preventing pain in the treated subject associated with elongation of the skin. Invasive treatment method. The method of claim 1,
The positive pressure phase is considerably longer than the negative pressure phase, noninvasive treatment of adipose tissue. 3. The method of claim 2,
Wherein said positive pressure phase period is 0.1-10 seconds and said negative pressure phase period is 0.1-100 milliseconds (ms). The method of claim 3, wherein
Wherein said positive phase phase period is sufficient to ensure joint skin-fat tissue migration of the outer skin layers and the adipose tissue layer. The method of claim 1,
Wherein said negative pressure is below -1 Bar at a depth of 5 mm, below -0.7 Bar at a depth of 10 mm, and below -0.4 Bar at a depth of 15 mm, below the upper skin layer, which is supple but not stretched. The method of claim 1,
The negative pressure inside the adipose tissue generates a pulling force to destroy the adipose tissue cells, non-invasive treatment method of adipose tissue. The method according to claim 6,
Further strengthening the effect of the negative pressure on adipose tissue by heating the adipose tissue to at least 37 ° C., non-invasive treatment method of adipose tissue. The method of claim 7, wherein
The heating of the adipose tissue above 37 ° C. is by one of a group of energies applied by an RF electrode, an ultrasonic transducer, and a light source. The method of claim 1,
And the repetition rate of the negative and positive pressure phases is 10-0.1 cycles / second. The method of claim 1,
The movement of the piston and the rod creates the negative and positive pressure phases. 11. The method of claim 10,
And employing a salient sensor to limit the outward movement of the piston and rod and to minimize the risk of skin elongation. In the non-invasive method of treating adipose tissue volume,
Providing an applicator comprising one or more chambers having a rim; And
In the adipose tissue by applying the rim of the applicator to the skin on the adipose tissue:
At least one positive pressure phase relative to the periphery by pushing the skin surface above the adipose tissue into the subject body; And
Drawing a skin surface over the adipose tissue volume from the subject body into the chamber of the applicator to generate one or more negative pressure phases around the periphery;
The negative pressure phase immediately follows the positive pressure phase,
During the positive pressure phase the skin is bent inward and during the negative pressure phase the skin is bent outwardly from the subject body without elongation, thereby preventing pain in the treated subject associated with stretching of the skin segment located in the rim of the chamber, Non-invasive method of treatment of adipose tissue volume. 13. The method of claim 12,
The applicator comprises a piston having one or more one-way valves,
And the one-way valve prevents occasional increase in pressure in the air pocket between the piston and the skin surface drawn into the chamber of the applicator. The method of claim 13,
And the piston consists of a rigid body having a curved convex surface. 13. The method of claim 12,
Wherein the applicator further comprises a piston comprised of a flexible membrane. The method of claim 15,
And said flexible membrane comprises an RF electrode. The method of claim 15,
The piston consists of a flexible membrane inserted into a flexible hinge type circular channel,
And wherein the stiffness of the circular channel is lower than the membrane. 13. The method of claim 12,
Wherein the period of positive pressure phase is considerably longer than the period of negative pressure phase. The method of claim 18,
The duration of the positive pressure phase is 0.1-10 seconds and the duration of the negative pressure phase is 0.1-100 milliseconds (ms) and the period is sufficient to ensure joint skin-fat tissue migration of the outer skin layers and the adipose tissue layer. Method of non-invasive treatment of tissue volume. 13. The method of claim 12,
Wherein said negative pressure is below -1 Bar at a depth of 5 mm, below -0.7 Bar at a depth of 10 mm, and below -0.4 Bar at a depth of 15 mm, below the upper skin layer, which is supple but not stretched. 13. The method of claim 12,
The negative pressure inside the adipose tissue generates a pulling force to destroy the adipose tissue cells, non-invasive treatment method of adipose tissue. 22. The method of claim 21,
Further strengthening the effect of the negative pressure on adipose tissue by heating the adipose tissue to at least 37 ° C., non-invasive treatment method of adipose tissue. 23. The method of claim 22,
The heating of the adipose tissue above 37 ° C. is by one of a group of energies applied by an RF electrode, an ultrasonic transducer, and a light source. 13. The method of claim 12,
The method of claim 1,
And the repetition rate of the negative and positive pressure phases is 1-0.1 cycles / second. 13. The method of claim 12,
Wherein said negative and positive pressure phases have a cycle and amplitude selected to maximize destruction of adipose tissue cells and minimize damage to other tissues. Applicator for non-invasive treatment of adipose tissue,
A chamber having a rim against the skin surface; And
An actuator for moving a piston located in the chamber,
Movement of the piston pulls the skin surface above the adipose tissue out of the subject's body, thereby creating one or more positive pressure phases relative to the periphery and one or more negative pressure phases relative to the periphery. Let's
During the positive pressure phase the piston movements slowly bend the skin inwards and during the negative pressure phase the piston movements rapidly bends the skin out of the subject body without stretching the skin, thereby preventing pain associated with the stretching of the skin. Applicator for non-invasive treatment of adipose tissue. The method of claim 26,
Wherein the piston consists of a rigid body having a curved convex surface. The method of claim 27,
And the piston includes one or more one-way valves to expel air trapped between the skin and the piston. 29. The method of claim 28,
The piston moves between the push phase and the pull phase,
Wherein said valve operates to expel air trapped between the skin and the piston during said pushing phase. The method of claim 26,
Wherein said piston is comprised of a flexible membrane; 31. The method of claim 30,
The flexible membrane includes an RF electrode, the applicator for non-invasive treatment of adipose tissue volume. 29. The method of claim 28,
The piston consists of a flexible membrane inserted into a flexible hinge type circular channel,
Wherein the stiffness of the circular channel is lower than that of the membrane. The method of claim 26,
The piston moves between a slow pushing phase and a fast pulling phase, wherein the pushing bends the skin into the subject's body during the pull phase and during the pull phase pulls the skin out of the subject body without stretching the skin located in the rim of the chamber. An applicator for non-invasive treatment of adipose tissue volume that flexes and thus prevents pain in the treated subject associated with the kidneys of the skin. The method of claim 26,
Wherein said actuator is one of a group of actuators comprising a positive and negative pressure applying actuator, a rack-pinion device, a worm gear, and a stepper motor with gears and springs. The method of claim 26,
Wherein the piston is coupled to the rod and the sensor restricts the outward movement of the piston and the rod to further minimize the risk of skin elongation. 36. The method of claim 35,
Wherein said sensor is one of a group of sensors consisting of a photoelectric protruding sensor or a mechanical stop mechanism. The method of claim 26,
The applicator,
A piston coupled to the actuator by a rod; And
Including the spring,
Wherein the spring displaces the rod and causes displacement of the piston and skin out of the subject body, thereby non-invasively treating the adipose tissue volume. The method of claim 26,
Wherein the chamber of the applicator has an opening in communication with the ambient atmosphere to prevent an increase in pressure in the chamber during protrusion formation. The method of claim 26,
An applicator for non-invasive treatment of adipose tissue volume further comprising at least one energy source acting on a tissue temperature that heats the tissue above 37 ° C. 40. The method of claim 39,
Wherein the energy source acting on the tissue temperature is by one of a group of RF electrodes, an ultrasonic transducer, and a light source, the applicator for non-invasive treatment of adipose tissue volume. 41. The method of claim 40,
Wherein the RF electrodes are one or more of a group of electrodes consisting of a circular electrode, a partial electrode of a circle, and a center electrode, wherein the applicator for non-invasive treatment of adipose tissue volume.

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