(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2013/0123765 A1
`Zarsky et al.
`(43) Pub. Date:
`May 16, 2013
`
`US 2013 0123765A1
`
`(54) METHODS AND SYSTEMS FOR
`SUBCUTANEOUSTREATMENTS
`(75) Inventors: Jan Zarsky, Framingham, MA (US);
`Tomás Schwarz, Prague (CZ)
`(73) Assignee: BTL HOLDINGS LIMITED, Limassol
`(CY)
`(21) Appl. No.: 13/297,934
`1-1.
`(22) Filed:
`
`Nov. 16, 2011
`Publication Classification
`
`(51) Int. Cl.
`A6 IB 8/8
`A6IN 5/06
`
`(2006.01)
`(2006.01)
`
`(52) U.S. Cl.
`USPC ............................................... 606/13:607/90
`
`(57)
`
`ABSTRACT
`
`Methods for focused remodeling and downsizing the volume
`of Subcutaneous lipid-rich cells, body contouring, and tight
`ening skin tissue, using controlled heating of the targeted
`areas on the body. The electromagnetic energy heats the Sub
`cutaneous tissues which provides the desired effect. The elec
`tromagnetic energy is applied via an applicator without con
`tinuously moving the applicator. A spacer of insulating or
`dielectric material may be provided between the applicator
`and the skin.
`
`16-N
`
`
`
`POWER
`SOURCE
`
`O O
`POWER
`SBEY
`
`-(O
`HF
`GENERATOR
`
`1.
`TRANSMATCH
`
`BALUN
`TRANSFORMER
`
`TRANSMATCHAND
`GENERATOR
`CONTROL UNIT
`
`MICROPROCESSOR
`CONTROLUNT WITH
`USERINTERFACE
`
`LUMENIS EX1064
`Page 1
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`Patent Application Publication May 16, 2013 Sheet 1 of 2
`
`US 2013/O123765 A1
`
`POWER
`
`SOURCE
`
`DO
`POWER
`SUPPLY
`
`(O
`HF
`GENERATOR
`
`1.
`
`TRANSMATCH
`
`Sec.
`TRANSFORMER
`
`TRANSMATCHAND
`GENERATOR
`CONTROL UNIT
`
`MICROPROCESSOR
`CONTROL UNIT WITH
`USERINTERFACE
`
`FIG. 1
`
`FIG. 2
`
`
`
`
`
`2
`
`
`
`W
`
`w
`
`w
`
`
`
`
`
`
`
`LUMENIS EX1064
`Page 2
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`Patent Application Publication May 16, 2013 Sheet 2 of 2
`
`US 2013/O123765 A1
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`
`
`20
`
`20
`
`FIG. 3
`
`FIG. 4
`
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`US 2013/O123765 A1
`
`May 16, 2013
`
`METHODS AND SYSTEMIS FOR
`SUBCUTANEOUSTREATMENTS
`
`FIELD OF THE INVENTION
`0001. The field of the invention is non-invasive, non-trau
`matic focused remodeling and downsizing Subcutaneous
`lipid-rich cells, body contouring and skin tightening. In par
`ticular, the invention relates to controlled heating of the tar
`geted areas on the human body using electromagnetic waves
`without a need for continuous movement of an applicator or
`electrode.
`
`BACKGROUND OF THE INVENTION
`0002 Human skin is composed of three basic elements:
`the epidermis, the dermis and the hypodermis or so called
`Subcutis. The dermis consists of collagen, elastic tissue and
`reticular fibers. The hypodermis is the lowest layer of skin and
`contains hair follicle roots, lymphatic vessels, collagentissue,
`nerves and also subcutaneous fat forming an adipose fattis
`Sue. Adipose fat tissue is formed by aggregation of fat cells
`containing stored lipid (fat). Most fat tissue accumulations
`result from lipids (fat) primarily from food, when energy
`intake derived from food exceeds daily energy needs. This
`may result in an increase in fat cell size or fat cell number or
`both. Mature fat cells are very large, ranging up to 120
`microns in diameter and containing as much as 95% lipid (fat)
`by Volume. The Subcutaneous adipose tissue layer may be
`thin (about 1 cm or less) or in humans of slight or moderate
`body type.
`0003 Excess adipose tissue may be perceived as aestheti
`cally undesirable. Dieting and exercise may result in reduc
`tion of adipose tissue and weight loss. However, for most
`people, the reduction in adipose tissue Volume occurs rather
`unpredictably from all anatomical areas. This can leave the
`areas intended for reduction, for example, the abdomen,
`largely unaffected, even after significant body weight loss.
`Various invasive and non-invasive methods have been devel
`oped to remove unwanted Subcutaneous fat from specific
`areas of the body.
`0004. The main invasive method is surgical-assisted lipo
`Suction, where selected Volumes of Subcutaneous fat are
`mechanically aspirated out from the patient at desired ana
`tomical sites of the body. However, liposuction procedures
`are invasive and can be painful and traumatic, with many
`undesirable side effects and risks. Lipodissolve is another
`invasive procedure involving a series of drug injections
`intended to dissolve and permanently remove Small pockets
`of fat from various parts of the body. It also is known as
`mesotherapy, lipoZap, lipotherapy, or injection lipolysis.
`Lipodissolve also has many disadvantages and risks, to the
`extent that various medical associations have issued health
`warnings against using it.
`0005. The non-invasive methods concentrate on the accel
`eration of the lipolysis as the natural process of the fat reduc
`tion. This can be achieved in several ways. One of them is
`application of pharmaceuticals accelerating the lipolysis.
`However, when applied topically they tend only to affect the
`outermost layers of the skin, rarely penetrating to the Subder
`mal vascular plexus. Another method uses radio frequency or
`ultrasound energy focused on adipose tissue to cause cell
`destruction and death. These methods tend to damage the
`melanocyte in the epidermis. The hyperthermic temperatures
`destroy the target tissues and leave the body to remove the
`
`dead cellular and other debris. Non-invasive heating tech
`niques have also been used. These involve heating the adipose
`fat tissue to about 40°C. or higher via direct contact with a
`heating element. These non-invasive methods have certain
`disadvantages as well, and have been used with varying
`degrees of Success.
`0006. Accordingly, there is need for improved methods
`and systems for Subcutaneous treatments.
`
`SUMMARY OF THE INVENTION
`0007 New methods have now been invented. A method
`for treating Subcutaneous tissue includes positioning one or
`more applicators adjacent to the skin of a patient, without a
`need for continuously moving the applicator. The applicator
`may be positioned so that it does not touch the skin. Electro
`magnetic energy is transmitted from the applicators into the
`Subcutaneous tissue. The Subcutaneous tissue is heated via
`the electromagnetic energy. The Subcutaneous tissue may be
`remodeled. The volume of lipid-rich cells in the subcutaneous
`tissue may be reduced via the heating.
`0008. The electromagnetic waves may be applied in a
`pulsed mode or in a continuous mode. The skin may option
`ally be actively cooled, without contacting the skin. This
`method may also be used for tightening the skin and for
`remodeling collagen tissue in the Subcutaneous tissue. The
`applicator may be spaced apart from the skin of the patient.
`There is no need to continuously move the applicator. One or
`more applicators may be supported on fixtures or holders,
`rather than hand-held. Exclusive and continuous attention to
`the treatment by an experienced user of the system may not
`necessarily be required.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`0009 FIG. 1 is a schematic diagram of a system for con
`trolled deep heating of Sub dermal tissues.
`0010 FIG. 2 is a schematic view of a trans-regional course
`of electromagnetic field;
`0011
`FIGS. 3 and 4 are schematic examples of position
`ing of electrodes shown in FIG. 1.
`
`DETAILED DESCRIPTION
`0012 Methods and apparatus for focused remodeling and
`downsizing the Volume of subcutaneous lipid-rich cells, body
`contouring and tightening skin tissue, without contact with
`the skin, have now been invented. Prior art methods generally
`require direct contact of an applicator onto the skin. This in
`turn typically also requires use of active skin cooling ele
`ments. Direct skin contact can also raise bio-compatibility
`issues with the applicator material and further requires high
`sanitary standards, since the applicators are used for treat
`ment of different patients. With the prior art methods, the
`practitioner must also continuously move the applicator, to
`reduce the risk of burning the patient.
`0013 These disadvantages are overcome by transmitting
`electromagnetic energy into the Sub Subcutaneous tissue,
`without physical contact with the patient, and without a need
`for continuous movement of the applicator. The step and
`repeat movements of the applicator over a grid pattern on the
`patient’s skin is obviated. With the applicator applying heat
`ing over a larger area, constant movement of the applicator is
`not needed. The applicator may remain in a stationery posi
`tion relative to the patient for several seconds or longer, for
`example, for at least 10, 30, 60, 120 or 240 seconds, or longer.
`
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`US 2013/O123765 A1
`
`May 16, 2013
`
`Contactless application enables simultaneous treatment of
`large areas of human body. It also avoids the need for artificial
`cooling of the skin. In the present contactless methods, the
`skin may be sufficiently cooled passively by circulating air.
`Optionally, the skin may be cooled via a stream of chilled or
`room temperature air. The present methods also do not
`require use of cooling fluids and gels. This reduces costs and
`increases patient comfort.
`0014. In one aspect, the present methods work on the
`principle of selective deep heating of the human tissue con
`taining low volume of water, such as adipose tissue. Radiant
`energy may be provided to the Sub dermal tissue by one or
`more capacitive electrodes generating an electromagnetic
`field. Selective heating in the dermis occurs due to dielectric
`losses. An inductive electrode may alternatively be used.
`0015. In a continuous application mode, the electromag
`netic field is applied continuously, which provides a maxi
`mum amount of heating. Using a pulse mode, the heat is local
`and typically limited to about 400 W. With the pulse mode, a
`high frequency field is applied in short intervals (typically
`(50-2000 us) and at various pulse frequencies (typically 50 to
`1500 Hz or pulses per second). The maximum Output during
`the continuous method is typically limited to 200 W.
`0016. The increase of the temperature in the dermal and
`the sub dermal tissues also affects the triple-helix structure of
`collagen fibers contained in Such tissues. This may result in
`remodeling and rejuvenation of collagen, increase of skin
`density and dermal thickening based on neocollagenesis.
`Skin tightening may also be achieved.
`0017 Remodeling and reducing the volume of subcutane
`ous lipid-rich cells, and skin tightening in the targeted areas,
`can change the overall appearance of the body, for use in body
`contouring and body reshaping.
`00.18
`Electromagnetic energy is provided through the
`skin to the underlying Sub dermal tissue, without contacting
`the skin. The radiant energy is converted into heat in the sub
`dermal tissue. The radiant energy enables focused heating of
`the Subcutaneous adipose tissue and Sub dermal collagen
`tissue, leading to accelerating lipolysis. At the same time the
`triple-helix structure of collagen fibers may result in remod
`eling and/or rejuvenation of collagen, increase of skin density
`and dermal thickening based on neocollagenesis. Subcutane
`ous lipid-rich cells may be remodeled and/or reduced in vol
`ume, contouring and tightening skin tissue.
`0019 Referring now to FIG. 1, a system 16 applies elec
`tromagnetic energy through a skin layer, Such as the epider
`mis, and to the underlying Sub dermal tissue, and underlying
`collagentissue, causing acceleration of lipolysis and collagen
`remodeling. The system may include 6 blocks. The power
`Supply 10 is connected to a power source. An HF generator
`(high frequency generator) 11 and a transmatch and generator
`control unit 14, and a microprocessor control unit with user
`interface 15, are connected to the power supply 10. The HF
`generator 11 may generate an electromagnetic field at 13.56
`or 40.68 or 27.12 MHz, or 2.45 GHZ, or optionally at other
`frequencies as well. The 13.56, 27.12 and 40.68 MHz and
`2.45 GHZ, frequencies avoid creating radio interference, as
`these frequencies are exclusively assigned as free frequen
`C1GS.
`0020. The microprocessor control unit with user interface
`15 provides communication between the transmatch and gen
`erator control unit 14 and user interface, which may be a touch
`screen on the device display.
`
`0021. The transmatch and generator control unit 14
`receives information from the operator via the control unit
`and regulates the operation of the HF generator 11 and the
`transmatch 12. The transmatch transmits HF to a balun trans
`former 13, which converts unbalanced impedance to bal
`anced impedance. This processed signal goes to two capaci
`tive applicators 6, which may be positioned approximately
`2-3 cm above the surface of the skin or applied on dielectric
`material which is in contact with the skin Surface.
`0022 FIG. 2 is a schematic representation of a heat distri
`bution under the skin. One or more applicators 6 create an
`electromagnetic field. This electromagnetic field crosses
`through the skin 2, Subcutaneous fat 3 and muscle 4 or the
`bone 5. Capacitive applicators 6 provide deep heating, which
`heats selectively only structures with low volume of water. A
`spacer 7 of a dielectric or non electrically conductive mate
`rial. Such as a towel, gauze pad, foam pad, cloth pad, etc. may
`be placed on the skin, with the applicator then placed on top
`of the spacer 7.
`0023. A selective heating process is observed in the dermis
`3 due to dielectric losses. Dielectric loss is created as part of
`an AC electromagnetic field power is converted to heat in the
`dielectric. During this process, polar molecules rotate, and
`their movement produces the thermal energy. Skin and
`muscle are largely not affected by electromagnetic field 1 as
`they contain water and the blood circulation provides for
`cooling. Bone 5 gets little if any heating because the applica
`tors 6 are positioned to create a field only on the upper struc
`tures. The lipid cells of the adipose tissue contain less water
`than the Surrounding tissue and are therefore heated at higher
`level than the Surrounding tissue.
`0024 FIGS. 3 and 4 are schematic examples of position
`ing of the applicators or electrodes 6 providing radiant energy
`through the skin 2 to subcutaneous fat 3. The electrodes are
`positioned approximately 2-3 cm above the surface of the
`skin or placed onto a spacer 7 which is in contact with the skin
`surface, as shown in FIG. 2. The spacer 7, if used, may
`correspondingly be 0.5 to 1 cm thick. The applicator 6 may be
`temporarily fixed in position relative to the patient, if desired,
`for example on a mechanical fixture or holder 20. The fixture
`20 may be a rigid bracket, a flexible gooseneck arm, an
`adjustable position arm, etc. Two or more applicators may be
`Supported on a single fixture 20 or on separate fixtures.
`0025. It is not necessary in each instance for the applicator
`to be continuously moving during the procedure. This makes
`the procedure easier to perform, since user need not con
`stantly keep moving the applicator over the patient's skin.
`Consequently, the user can accordingly simultaneously
`attend to other needs of a patient. The applicator 6 may have
`a relatively large surface area, so that the field 1 is distributed
`more widely through the Subcutaneous tissue. For example,
`the applicator may have a surface area of at least about 15, 30,
`50, 75, 100 or 150 cm.
`0026 Methods may include one or more of the following
`steps: positioning a spacer in between the applicator and the
`skin of the patient; transmitting electromagnetic energy in the
`range of 13.553-13.567 or 26.957-27.83 or 40.66-40.70 MHz
`or 2.4-2.5 GHZ, from the applicator into the subcutaneous
`tissue; and placing or holding the applicatorina fixed position
`relative to the tissue for at least 60 seconds; optionally with
`the applicator not touching the skin of the patient. If two or
`more applicators are used, the applicators may be positioned
`on opposite sides of the patient. The applicator may be an
`inductive electrode, or two or more capacitive electrodes.
`
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`US 2013/O123765 A1
`
`May 16, 2013
`
`0027. The electromagnetic waves may be applied in a
`continuous mode, or pulse mode with a power range of e.g.
`30-400 W per pulse.
`0028. Thus, novel methods and systems have been shown
`and described.
`0029. Various modifications and substitutions may be
`made without departing from the spirit and scope of the
`invention. The invention, therefore, should not be limited,
`except by the following claims and their equivalents.
`1. A method for treating Subcutaneous tissue having a
`Volume of lipid-rich cells, comprising:
`positioning an applicator adjacent to the skin of a patient;
`transmitting radio frequency electromagnetic waves from
`the applicator into the Subcutaneous tissue, with the
`applicator remaining in a fixed position relative to the
`tissue for at least 10 seconds;
`heating of the Subcutaneous tissue via the radio frequency
`electromagnetic waves; and
`remodeling and/or reducing the Volume of lipid-rich cells
`in the Subcutaneous tissue via the heating.
`2. The method of claim 1 further comprising applying the
`radio frequency electromagnetic waves in a pulsed mode.
`3. The method of claim 2 further comprising applying the
`radio frequency electromagnetic waves with pulse of width
`between 50-2000 micro seconds and pulse frequency range
`from 50-1500 HZ.
`4. The method of claim 2 further comprising applying the
`radio frequency electromagnetic waves with a power range is
`30-400 W per pulse.
`5. The method of claim 1 further comprising applying the
`radio frequency electromagnetic waves in a continuous
`mode.
`6. The method of claim 1 further comprising cooling the
`skin without contacting the skin.
`7. The method of claim 1 wherein the temperature of skin
`is increased to about 32-45° C. while treating the subcutane
`ous tissue underneath the skin.
`8. The method of claim 1 further comprising positioning a
`second applicator adjacent to the skin of the patient, with
`applicators not touching the skin of the patient, and with the
`applicators comprising capacitive electrodes.
`
`9. The method of claim 1 wherein the applicator comprises
`an inductive electrode.
`10. The method of claim 1 further comprising transmitting
`radio frequency electromagnetic waves in the range of
`13.553-13.567 or 26.957-27.283 or 40.66-40.70 MHZ or 2.4-
`2.5 GHz from the applicator into the subcutaneous tissue.
`11. The method of claim 1 further comprising positioning
`a spacer in between the applicator and the skin of the patient.
`12. The method of claim 1 with the applicator not directly
`touching the skin of the patient.
`13. The method of claim 1 with the applicator remaining in
`a fixed position relative to the tissue for at least 30 seconds.
`14-30. (canceled)
`31. A non-invasive method for treating Subcutaneous tissue
`having a Volume of lipid-rich cells, comprising:
`positioning an applicator adjacent to the skin of a patient;
`positioning a spacer in between the applicator and the skin
`of the patient;
`transmitting radio frequency electromagnetic waves from
`the applicator into the Subcutaneous tissue, with the
`applicator remaining in a fixed position relative to the
`tissue for at least 10 seconds;
`heating the Subcutaneous tissue via radio frequency elec
`tromagnetic waves, with the temperature of skin over the
`subcutaneous tissue increased to about 32-45° C.; and
`remodeling and/or reducing the Volume of lipid-rich cells
`in the Subcutaneous tissue via the heating.
`32. The method of claim 31 with the spacer 0.5 to 1 cm
`thick.
`33. The method of claim 31 further comprising cooling the
`skin without contacting the skin.
`34. The method of claim 31 with the electromagnetic
`waves having a frequency in the range of 13.553-13.567 or
`26.957-27.283 or 40.66-40.70 MHZ or 2.4-2.5 GHZ.
`35. The method of claim 31 further comprising transmit
`ting the radio frequency electromagnetic waves in a continu
`ous mode.
`36. The method of claim 31 further comprising cooling the
`skin.
`
`k
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`k
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`k
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`k
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`k
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`LUMENIS EX1064
`Page 6
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