(19) United States
`(12) Patent Application Publication (10) Pub. No.: US 2015/0025299 A1
`(43) Pub. Date:
`Jan. 22, 2015
`RON EDOUTE et al.
`
`US 2015.0025299A1
`
`(54)
`
`(71)
`(72)
`
`ESTHETIC APPARATUS USEFUL FOR
`INCREASING SKIN REUVENATION AND
`METHODS THEREOF
`
`Applicant: VENUS CONCEPT LTD, Karmiel (IL)
`Inventors: Oded RON EDOUTE, Tel Aviv (IL);
`Orit RON EDOUTE, Tel Aviv (IL);
`Itzhak KREMIN, Givatayim (IL);
`Vadim POLYAKOV, Petach Tikva (IL)
`
`(21)
`
`Appl. No.: 14/489,572
`
`(22)
`
`Filed:
`
`Sep. 18, 2014
`
`Publication Classification
`
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`(2006.01)
`
`(51) Int. Cl.
`A6N2/00
`A6IN5/06
`A6F 7/00
`A6N2/02
`A6IN5/00
`(52) U.S. Cl.
`CPC A61N 2/002 (2013.01); A61N 2/02 (2013.01);
`A6IN5/00 (2013.01); A61F 7/007 (2013.01);
`A61N5/0625 (2013.01); A61F 7700 (2013.01);
`A61F 2007/0052 (2013.01)
`... 600/14: 607/103; 607/101: 607/98; 607/88;
`601/1; 601/15
`
`USPC
`
`(62)
`
`(60)
`
`Related U.S. Application Data
`Division of application No. 13/954,320, filed on Jul.
`30, 2013, which is a division of application No.
`13/001,834, filed on Feb. 1, 2011, filed as application
`No. PCT/IL2009/000644 on Jun. 29, 2009.
`Provisional application No. 61/076,652, filed on Jun.
`29, 2008, provisional application No. 61/112,783,
`filed on Nov. 10, 2008.
`
`ABSTRACT
`(57)
`Systems and methods for increasing skin rejuvenation of a
`region of a patient’s skin. The system includes: a pulsed
`electromagnetic field (PEMF) frequency generator that emits
`electromagnetic pulses to the region of the patient’s skin; and
`a deep tissue diathermy device that applies heat to the region
`of the patient’s skin up to temperature T. The system simul
`taneously applies the heat and the PEMF to the region of a
`patient’s skin.
`
`
`
`LUMENIS EX1061
`Page 1
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`

`

`Patent Application Publication
`
`Jan. 22, 2015 Sheet 1 of 17
`
`US 2015/0025299 A1
`
`Pulsed electromagnetic
`frequency generator
`
`
`
`Tissue heating
`apparatuS
`
`FIG. A
`
`LUMENIS EX1061
`Page 2
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`

`

`
`
`
`
`rasta=Pas 7
`
`
`
`FIG. 1B
`
`LUMENIS EX1061
`Page 3
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`LUMENIS EX1061
`Page 3
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`

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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 3 of 17
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`US 2015/0025299 A1
`
`
`
`FIG. 1C
`
`
`
`FIG. 1D
`
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`Patent Application Publication
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`Jan. 22, 2015 Sheet 4 of 17
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`US 2015/0025299 A1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`f
`
`SS ecords
`
`FIG, IE
`
`LUMENIS EX1061
`Page 5
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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 5 of 17
`
`US 2015/0025299 A1
`
`
`
`Power Supply and
`control System
`
`Pulsed electromagnetic
`frequency generator
`
`Tissue heating
`apparatuS
`
`FIG. 2
`
`LUMENIS EX1061
`Page 6
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`

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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 6 of 17
`
`US 2015/0025299 A1
`
`PEMF for Angiogenesys
`
`Miliseconds
`
`FIG. 3
`
`
`
`PEMF for Collagen stimulation
`
`Miliseconcils
`
`FIG. 4
`
`LUMENIS EX1061
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`Patent Application Publication
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`Jan. 22, 2015 Sheet 7 of 17
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`US 2015/0025299 A1
`
`FIG. 5
`
`
`
`FIG. 6
`
`LUMENIS EX1061
`Page 8
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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 8 of 17
`
`US 2015/0025299 A1
`
`400 /N,
`
`obtaining (i) pulsed electromagnetic frequency generator; and, (ii)
`a deep tissue diathermy device
`
`401
`
`
`
`
`
`applying heat to a subcutaneous tissue within Said region up to
`temperature T
`
`402
`
`Applying pulsed electromagnetic therapy
`
`403
`
`FIG. T.
`
`LUMENIS EX1061
`Page 9
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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 9 of 17
`
`US 2015/0025299 A1
`
`400 /N
`
`
`
`obtaining (i) pulsed electromagnetic frequency generator; and, (ii) a
`deep tissue diathermy device
`
`Applying heat to a Subcutaneous tissue within Said region up to
`temperature T
`
`Applying pulsed electromagnetic therapy
`
`Monitoring tissue parameters and controlling pulsed electromagnetic
`frequency generator (2) and deep tissue diathermy device (4)
`accordingly
`
`FIG. 8
`
`LUMENIS EX1061
`Page 10
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`

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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 10 of 17
`
`US 2015/0025299 A1
`
`410 /N,
`
`
`
`obtaining (i) pulsed electromagnetic frequency generator; and, (ii)
`a deep tissue diathermy device
`
`Applying pulsed electromagnetic therapy
`
`Applying heat to a Subcutaneous tissue within Said region up to
`temperature T
`
`FIG. 9
`
`LUMENIS EX1061
`Page 11
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`

`

`Patent Application Publication
`
`Jan. 22, 2015 Sheet 11 of 17
`
`US 2015/0025299 A1
`
`410 /N
`
`
`
`Obtaining (i) pulsed electromagnetic frequency generator; and, (ii)
`a deep tissue diathermy device
`
`Applying pulsed electromagnetic therapy
`
`Applying heat to a Subcutaneous tissue within said region up to
`temperature T
`
`Monitoring tissue parameters and controlling pulsed
`electromagnetic frequency generator (2) and deep tissue diathermy
`device (4) accordingly
`
`FIG. O
`
`LUMENIS EX1061
`Page 12
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`

`

`Patent Application Publication
`
`Jan. 22, 2015 Sheet 12 of 17
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`US 2015/0025299 A1
`
`420 /N,
`
`Obtaining (i) pulsed electromagnetic frequency generator; and,
`(ii) a deep tissue diathermy device
`
`421
`
`Applying pulsed electromagnetic therapy whilst
`Simultaneously applying heat to a Subcutaneous tissue within
`Said region up to temperature T
`
`
`
`422
`
`
`
`
`
`
`
`
`
`
`
`FIG 11
`
`LUMENIS EX1061
`Page 13
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`

`

`Patent Application Publication
`
`Jan. 22, 2015 Sheet 13 of 17
`
`US 2015/0025299 A1
`
`420 /N,
`
`Obtaining (i) pulsed electromagnetic frequency generator; and, (ii) a
`deep tissue diathermy device
`
`42
`
`
`
`
`
`
`
`Applying pulsed electromagnetic therapy whilst simultaneously
`applying heat to a Subcutaneous tissue within Said region up to
`temperature T
`
`Monitoring tissue parameters and controlling pulsed electromagnetic
`frequency generator (2) and deep tissue diathermy device (4)
`accordingly
`
`422
`
`423
`
`FIG. 12
`
`LUMENIS EX1061
`Page 14
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`

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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 14 of 17
`
`US 2015/0025299 A1
`
`
`
`
`
`FIG.13C
`
`FIG.13F
`
`FIG.13D
`
`FIG.13B
`
`LUMENIS EX1061
`Page 15
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`

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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 15 of 17
`
`US 2015/0025299 A1
`
`Right Side-ths
`device of e
`presertieweries
`
`RightSide-the
`getic as
`presertiewettist
`
`Right Sicis-the
`cycle
`presentieties
`
`
`
`FIG.14E
`
`FIG.14C
`
`FIG.14A
`
`RightSide-the
`ce:$888
`presertisties:
`
`Rightside the
`device of the
`preservestics:
`
`Sise-RF
`s
`
`SERF
`
`S
`
`RisitSide-tie
`88site:8
`
`
`
`FIG.14F
`
`FIG.14D
`
`FIG.14B
`
`LUMENIS EX1061
`Page 16
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`

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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 16 of 17
`
`US 2015/0025299 A1
`
`RightSide-tie
`issets
`tive
`
`LetSide-PESF
`Š &
`
`RightSide-th:
`essee site
`
`Sise-FE
`8
`
`&
`
`tight Sicig-tite
`sistice site
`presertieties
`
`sit Side-FESF
`Šx$
`
`
`
`S
`FIG.15E
`
`Š
`FIG.15C
`
`FIG.15A
`
`RightSide-tie
`ce::88
`
`
`
`
`
`
`
`Sci-FESF
`
`Rigit Side-tire
`si:it:8:8
`eitsstie
`
`Rigit Sitie-ite
`&ices:
`se
`Sis
`
`F
`
`FIG.15F
`
`FIG.15D
`
`FIG.15B
`
`LUMENIS EX1061
`Page 17
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`

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`Patent Application Publication
`
`Jan. 22, 2015 Sheet 17 of 17
`
`US 2015/0025299 A1
`
`RightSide-tre
`dies:e of the
`present invention
`
`Rigt Scie-the
`ess.
`FESF fesweet by RF device of the
`settias
`
`Side:
`RightSide-the
`Sis
`PEI followed
`Exce tie-ice af 8. 8.8
`presentity ention by R.
`
`FIG.16E
`
`FIG.16C
`
`FIG.16A
`
`RightSide-tive
`ties:
`the
`
`
`
`&Sier
`RightSide-the
`PERF followed by RF is
`
`
`
`RightSide-the
`device of the
`
`FIG.16F
`
`FIG.16D
`
`FIG.16B
`
`LUMENIS EX1061
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`US 2015/0025299 A1
`
`Jan. 22, 2015
`
`ESTHETIC APPARATUS USEFUL FOR
`INCREASING SKIN REUVENATION AND
`METHODS THEREOF
`
`FIELD OF THE INVENTION
`0001. This invention generally relates to an esthetic device
`used to improve skin viability and skin rejuvenation, and a
`method of using the device.
`
`BACKGROUND OF THE INVENTION
`0002 Improving the appearance of the skin has been the
`goal of many esthetic products and procedures for many
`years, since a tight skin, without wrinkles or cellulite, has a
`younger and more appealing appearance. Apart from age
`related changes, the skin also Suffers from exposure to chemi
`cal and physical injuries, such as tobacco, cosmetics, esthet
`ics and radiation from the Sun and other sources. Those fac
`tors contribute to the decrease in collagen production, to
`reduced elasticity, and the appearance of wrinkles
`0003. A few main approaches to tightening of the skin are
`common practice today. The Surgical approach carries disad
`Vantages related to the anesthesia, the Surgical complications,
`and the healing process, which may cause Scars. The chemical
`peel approach usually involves injury to the outermost layer
`of the skin—the epidermis—which may cause discoloration.
`Since collagen fibers are found in the dermis—the subcuta
`neous layer of the skin, and since heat was shown to contract
`these fibers and generate their production Zelickson B D.
`Kist D, Bernstein E, Brown D B, Ksenzenko S, Burns J.
`Kilmer S. Mehregan D. Pope K. Histological and ultrastruc
`tural evaluation of the effects of a radiofrequency-based
`nonablative dermal remodeling device: a pilot study. Arch
`Dermatol. 2004 February: 140(2):204-9), methods of differ
`entially heating the dermis (deep tissue diathermy) have
`recently arisen.
`0004. A unique method of treating the dermis is called
`Pulsed Electromagnetic Fields (PEMF) therapy. This method
`usually employs electromagnetic radiation of different fre
`quencies—ranging from static magnetic fields, through
`extremely low frequencies (ELF) to higher radiofrequencies
`(RF)—administered in pulses.
`0005 PEMF works in few ways. Due to the radiation
`absorbed in the tissue, it can be heated to various tempera
`tures, depending on the power applied, the frequency trans
`mitted, and more importantly the tissue characteristics. Even
`tually, the tissue can be warmed to denaturation temperatures,
`which cause coagulation necrosis and tissue damage. It can
`also be heated to lower temperatures, which proved to result
`in the afore-mentioned contraction of collagen fibers.
`0006 Another modus operandi involves non thermal
`effects. These rely on specific tissue components and their
`reaction to the applied radiation characteristics. These effects
`might be due to large charged molecules and their reaction to
`various frequencies and frequency harmonies, charged Small
`ions in the cell membranes affecting the cells function and
`reactions to hormones and chemical signals, charged Small
`ions in the extracellular space and other poorly understood
`mechanisms.
`0007 Furthermore, applying the radiation in pulses was
`also found to have non thermal effects. Yet more, only a
`specific combination of frequency, duty cycle and transmitted
`power achieve a specific tissue response. Recent scientific
`
`research has confronted these challenges and found the
`PEMF characteristics needed for the desired biophysical
`response.
`0008. It is now commonly accepted that weak electromag
`netic fields (EMF) administered in pulses are capable of ini
`tiating various healing processes in fractures, multiple scle
`rosis and Parkinson's disease, and even delivering pain relief
`however it seems that most of the conditions that seem most
`likely to respond to PEMF are musculoskeletal. The FDA has
`allowed the use of pulsed radiofrequency electromagnetic
`field for treatment of pain and edema in superficial soft tissues
`two decades ago. Rosch, P. J., Markov, M. S., eds. Bioelec
`tromagnetic Medicine, Marcel Dekker, NY, 251-264).
`0009. The use of PEMF can also be recruited for cosmetic
`purposes as described above. Several studies have addressed
`the effect of PEMF on dermal components. For example, in
`vivo trials showed that pulsed electromagnetic field of certain
`field intensities and frequencies increased epidermal collagen
`synthesis Ahmadian S, Zarchi S R. Bolouri B. Effects of
`extremely-low-frequency pulsed electromagnetic fields on
`collagen synthesis in rat skin. Biotechnol Appl Biochem.
`2006 February; 43(Pt 2):71-5). This new formed collagen
`increases skin elasticity and rejuvenates its appearance.
`0010. In vitro trials showed that PEMF increased the
`degree of endothelial cell tubulization and proliferation, and
`augmented angiogenesis primarily by stimulating endothelial
`release of FGF-2, inducing paracrine and autocrine changes
`in the surrounding tissue Tepper O Metal. Electromagnetic
`fields increase in vitro and in vivo angiogenesis through
`endothelial release of FGF-2. FASEB.J. 2004 August; 18(11):
`1231-3. Epub 2004 Jun. 18. Angiogenesis, the sprouting of
`new blood vessels, increases blood flow to the tissue, which in
`turn increases oxygen and nutritional Substances delivery to
`the tissue. This effect is most beneficial for an injured tissue,
`promoting rapid and improved healing. The growth factor
`released further enhances the healing process, both in quality
`and time of improvement.
`0011. The scientific evidence of the effect of PEMF on
`tissues was utilized in various applications. For example,
`US20050182462A1 discloses healthy deep tissue heating
`using PEMF for the purpose of causing contraction and tight
`ening of the skin.
`0012 PEMF has also been used to improve skin wound
`healing. For example, WO08064272 discloses a method of
`treating a severe diabetic ulcer using PEMF. The patent also
`discloses the addition of intermittent compression therapy
`(ICT) and the use of low intensity ultrasound (up to 50
`W/cm), the latter aimed at inhibiting microbial growth.
`0013. Other methods of heating the dermis used non pull
`sating RF radiation, applied by antenna or electrodes. For
`example, WO98005380 discloses a method of tightening skin
`using an RF electromagnetic energy delivery device.
`0014 Improving the results of skin tightening based on
`dermis diathermy is still along felt need, both foresthetic and
`therapeutic purposes.
`
`SUMMARY OF THE INVENTION
`0015. It is one object of the present invention to provide a
`system (10) adapted to increase skin rejuvenation of a region
`of a patient’s skin, said system comprising
`0016 a. a pulsed electromagnetic field (PEMF) fre
`quency generator (2) for constantly providing electro
`magnetic pulses to said region of a patient’s skin; and,
`
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`US 2015/0025299 A1
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`Jan. 22, 2015
`
`0017 b. a deep tissue diathermy device (4) for con
`stantly applying heat to said region of a patient’s skin up
`to temperature T.
`said system (10) is adapted for simultaneously applying heat
`and PEMF to said region of a patient’s skin; wherein appli
`cation of said system increases said skin rejuvenation Such
`that said skin rejuvenation increase (SRI) is greater than the
`Sum of said SRI provided by electromagnetic pulses increase
`and said SRI provided by said deep tissue diathermy device
`increase.
`0018. It is another object of the present invention to pro
`vide the system as defined above, wherein said electromag
`netic pulse is a triangular shaped at frequency of 25 Hz and
`intensity of 20 Gauss.
`0019. It is another object of the present invention to pro
`vide the system as defined above, wherein said electromag
`netic pulse is square shaped at a frequency of 16 Hz, duration
`of about 5 milliseconds and intensity of 12 Gauss.
`0020. It is another object of the present invention to pro
`vide the system as defined above, wherein said deep tissue
`diathermy device (4) is selected from any device emitting RF
`radiation or any means adapted for producing electrical cur
`rent absorbed by subcutaneous tissue.
`0021. It is another object of the present invention to pro
`vide the system as defined above, wherein said deep tissue
`diathermy device (4) additionally comprises:
`0022 a. at least one electrical output device adapted to
`generate RF electromagnetic energy;
`0023 b. at least two electrodes electrically coupled to
`said electrical output device and placed on said skin
`region, wherein all said electrodes are adapted to simul
`taneously apply said RF energy to said skin region.
`0024. It is another object of the present invention to pro
`vide the system as defined above, wherein said deep tissue
`diathermy device (4) additionally comprises:
`0025 a. at least one electrical output device adapted to
`generate electrical current;
`0026 b. at least two electrodes electrically coupled to
`said electrical output device and placed on said skin
`region, wherein all said electrodes are adapted to simul
`taneously apply said electrical current to said skin
`region.
`0027. It is another object of the present invention to pro
`vide the system as defined above, wherein said system
`reduces side effects and/or harmful effects of said electro
`magnetic pulses and/or said deep tissue diathermy Such that
`said reduction of said side effects and/or said harmful effects
`is greater than the Sum of said reduction of said electromag
`netic pulses and/or said reduction of said deep tissue
`diathermy.
`0028. It is another object of the present invention to pro
`vide the system as defined above, wherein said system addi
`tionally comprising a control system (6) adapted to regulate
`said electromagnetic pulses and/or said electromagnetic
`pulses.
`0029. It is another object of the present invention to pro
`vide the system as defined above, wherein said pulsed elec
`tromagnetic frequency generator is adapted to provide a
`dynamic magnetic field Such that said electromagnetic pulses
`vary with time.
`0030. It is another object of the present invention to pro
`vide the system as defined above, wherein the shape of said
`electromagnetic pulse is selected in a non-limiting manner
`from a group consisting of square wave, a sine wave, a trian
`
`gular wave, sawtooth wave, ramp waves, spiked wave or any
`other mathematical combination.
`0031. It is another object of the present invention to pro
`vide the system as defined above, wherein the magnetic field
`intensity B of each pulse applied by said pulsed electromag
`netic frequency generator (2) ranges between about 0 and
`about 3 Tesla.
`0032. It is another object of the present invention to pro
`vide the system as defined above, wherein the duration of
`each pulse applied by said pulsed electromagnetic frequency
`generator (2) ranges between about 3 and about 1000 milli
`seconds.
`0033. It is another object of the present invention to pro
`vide the system as defined above, wherein the frequency F
`applied by the pulses of said pulsed electromagnetic fre
`quency generator (2) ranges between about 1 Hz and about
`1 MHZ.
`0034. It is another object of the present invention to pro
`vide the system as defined above, wherein the energy E
`applied by the pulses of said pulsed electromagnetic fre
`quency generator (2) ranges between about 1 and about 150
`watts per pulse.
`0035. It is another object of the present invention to pro
`vide the system as defined above, wherein said deep tissue
`diathermy device (4) is selected in a non-limiting manner
`from a group consisting of an ultrasonic diathermy, an optical
`device, electromagnetic induction, Sound waves emitting
`instrument, direct heat applying instrument, or from any other
`means of heating Subcutaneous tissue to temperature T.
`0036. It is another object of the present invention to pro
`vide the system as defined above, wherein said optical device
`is adapted to emit light in wavelengths absorbed by Subcuta
`neous tissue such that said Subcutaneous tissue is heated.
`0037. It is another object of the present invention to pro
`vide the system as defined above, wherein said sound waves
`emitting instrument is adapted to emit Sound waves absorbed
`by the Subcutaneous tissue such that said Subcutaneous tissue
`is heated.
`0038. It is another object of the present invention to pro
`vide the system as defined above, wherein said temperature T
`is higher than about 30 and lower than about 80 degrees.
`0039. It is another object of the present invention to pro
`vide the system as defined above, wherein said power Supply
`and control system (6) monitors physical tissue parameters
`and changes applied heat and electromagnetic pulses accord
`ingly.
`0040. It is another object of the present invention to pro
`vide the system as defined above, wherein said power Supply
`and control system (6) additionally comprising:
`0041 a. processing means, adapted to store in a com
`municable database predetermined parameters defining
`(i) safe treatment parameters and (ii) unsafe treatment
`parameters; said parameters are selected from a group
`consisting of time t of said treatment, temperature T of
`said tissue, ratio tT, Frequency F, power P. energy E
`applied by the pulses of said pulsed electromagnetic
`frequency generator, depth D of said treated tissue, mag
`netic field intensity B, tissue impedance, specific
`absorption rate (SAR), treatment depth, superficial
`muscle contractions or a combination thereof;
`0042 b. sensing means; adapted to sense electromag
`netic radiation and heat radiation parameters selected
`from a group consisting of time t of time t of said treat
`ment, temperature T of said tissue, ratio t(T. Frequency
`
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`US 2015/0025299 A1
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`
`F. power P. Intensity I of said ultrasound irradiation,
`energy E applied by the pulses of said pulsed electro
`magnetic frequency generator, depth D of said treated
`tissue, magnetic field intensity B, tissue impedance, spe
`cific absorption rate (SAR), treatment depth, superficial
`muscle contractions or a combination thereof;
`004.3
`c. regulating means, adapted to allow said elec
`tromagnetic radiation and heat radiation if said param
`eters are within said safe treatment parameters and to
`stop the electromagnetic radiation if the radiation
`parameters are in said unsafe treatment parameters.
`0044. It is another object of the present invention to pro
`vide the system as defined above, wherein said power Supply
`and control system (6) includes a mechanism for skin cooling.
`0045. It is another object of the present invention to pro
`vide the system as defined above, wherein said system (10) is
`encased in at least one platform.
`0046. It is another object of the present invention to pro
`vide the system as defined above, wherein said pulsed elec
`tromagnetic frequency generator (2) and said deep tissue
`diathermy device (4) have more than one applicator to treat
`more than one body part simultaneously.
`0047. It is another object of the present invention to pro
`vide the system as defined above, wherein said pulsed elec
`tromagnetic frequency generator (2) has electrostatic shield
`1ng.
`0048. It is another object of the present invention to pro
`vide the system as defined above, especially adapted to
`increase skin rejuvenation in the immediate (short) range.
`0049. It is another object of the present invention to pro
`vide the system as defined above, especially adapted to
`increase skin rejuvenation in the intermediate range.
`0050. It is another object of the present invention to pro
`vide the system as defined above, especially adapted to
`increase skin rejuvenation in the long range.
`0051. It is another object of the present invention to pro
`vide the system as defined above, wherein said system is
`especially adapted to operate according to IEC selected from
`a group consisting of IEC 60601-2-35, IEC 60601-2-33, IEC
`60601-2-29, IEC 60601-2-9, IEC 60601-2-5, IEC 60601-2-3,
`IEC 60601-1-8, IEC 60601-1-6, IEC 60601-1-4, IEC 60601
`1-3, IEC 60601-1-2, IEC 60601-1-1 or any combination
`thereof.
`0052. It is another object of the present invention to pro
`vide a method (400) of increasing skin rejuvenation of a
`region of a patient’s skin. The method comprises steps
`selected interalia from:
`0053 a. obtaining (i) pulsed electromagnetic frequency
`generator, and, (ii) a deep tissue diathermy device;
`0054 b. applying heat to a subcutaneous tissue within
`said region up to temperature T, and,
`0055 c. applying pulses of electromagnetic field to said
`region;
`wherein said increasing of said skin rejuvenation is greater
`than the Sum of said applying heat to a Subcutaneous tissue
`within said region increase and said applying pulses electro
`magnetic therapy to said region increase.
`0056. It is another object of the present invention to pro
`vide a method (410) of increasing skin rejuvenation of a
`region of a patient’s skin. The method comprises steps
`selected interalia from:
`0057 a. obtaining (i) pulsed electromagnetic frequency
`generator, and, (ii) a deep tissue diathermy device;
`
`b. applying pulses of electromagnetic field to said
`0.058
`region; and,
`0059 c. applying heat to a subcutaneous tissue within
`said region up to temperature T.
`wherein said increasing of said skin rejuvenation is greater
`than the Sum of said applying heat to a Subcutaneous tissue
`within said region and said applying pulses electromagnetic
`therapy to said region
`0060. It is another object of the present invention to pro
`vide a method (420) of increasing skin rejuvenation of a
`region of a patient’s skin. The method comprises steps
`selected interalia from:
`0061 a. obtaining (i) pulsed electromagnetic frequency
`generator, and, (ii) a deep tissue diathermy device;
`0062 b. applying heat to a subcutaneous tissue within
`said region up to temperature T, whilst simultaneously
`applying pulses of electromagnetic field to said region;
`wherein said increasing of said skin rejuvenation is greater
`than the Sum of said applying heat to a Subcutaneous tissue
`within said region and said applying pulses electromagnetic
`therapy to said region.
`0063. It is another object of the present invention to pro
`vide the methods as defined above, wherein said system
`reduces side effects and/or harmful effects of said electro
`magnetic pulses and/or said deep tissue diathermy Such that
`said reduction of said side effects and/or said harmful effects
`is greater than the Sum of said reduction of said electromag
`netic pulses and/or said reduction of said deep tissue
`diathermy.
`0064. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of monitoring and/or controlling said steps of applying
`heat to a subcutaneous tissue within said region and/or said
`step of applying pulsed electromagnetic therapy to said
`region.
`0065. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of applying a dynamic magnetic field onto said region.
`0066. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`steps of
`0067 a. storing in a communicable database predeter
`mined parameters defining (i) safe treatment parameters
`and (ii) unsafe treatment parameters; said parameters are
`Selected from a group consisting of time t of said treat
`ment, temperature T of said tissue, ratio t(T. Frequency
`F. power P. energy E applied by the pulses of said pulsed
`electromagnetic frequency generator, depth D of said
`treated tissue, magnetic field intensity B, tissue imped
`ance, specific absorption rate (SAR), treatment depth,
`Superficial muscle contractions or a combination
`thereof;
`0068 b. sensing electromagnetic radiation and heat
`radiation parameters selected from a group consisting of
`time t of said treatment, temperature T of said tissue,
`ratio t/T, Frequency F, power P. Intensity I of said ultra
`Sound irradiation, energy E applied by the pulses of said
`pulsed electromagnetic frequency generator, depth D of
`said treated tissue, magnetic field intensity B, tissue
`impedance, specific absorption rate (SAR), treatment
`depth, Superficial muscle contractions or a combination
`thereof;
`0069 c. allowing said electromagnetic radiation and
`said heat radiation if parameters within said safe treat
`
`LUMENIS EX1061
`Page 21
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`US 2015/0025299 A1
`
`Jan. 22, 2015
`
`ment parameters and to stop the electromagnetic radia
`tion if the radiation parameters are in said unsafe treat
`ment parameters.
`0070. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of selecting the shape of said electromagnetic pulse is
`selected in a non-limiting manner from a group consisting of
`square wave, a sine wave, a triangular wave, sawtooth wave,
`ramp waves, spiked wave or any other mathematical combi
`nation.
`0071. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of applying a triangular shaped electromagnetic pulse at
`frequency of 25 Hz and intensity of 20 Gauss.
`0072. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of applying a square shaped electromagnetic pulse at a
`frequency of 16 Hz, duration of about 5 milliseconds and
`intensity of 12 Gauss.
`0073. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of selecting said deep tissue diathermy device (4) from
`any device emitting RF radiation or any means adapted for
`producing electrical current absorbed by Subcutaneous tissue.
`0074. It is another object of the present invention to pro
`vide the methods as defined above, wherein said step of
`applying heat to a Subcutaneous tissue additionally compris
`ing steps of
`0075 a. obtaining at least one electrical output device
`adapted to generate RF electromagnetic energy;
`0076 b. electrically coupling at least two electrodes to
`said electrical output device;
`0077 c. placing said at least two electrodes on said skin
`region; and,
`0078 d. simultaneously applying via all said electrodes
`said RF energy to said skin region.
`0079. It is another object of the present invention to pro
`vide the methods as defined above, wherein said step of
`applying heat to a Subcutaneous tissue additionally compris
`ing steps of
`0080 a. obtaining at least one at least one electrical
`output device adapted to generate electrical current;
`I0081
`a. electrically coupling at least two electrodes to
`said electrical output device;
`I0082
`b. placing said at least two electrodes on said skin
`region; and,
`I0083
`c. simultaneously applying via all said electrodes
`said electrical current to said skin region.
`0084. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of selecting said temperature T from a region of about 30
`to about 80 degrees.
`0085. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of selecting the duration of each pulse applied by said
`pulsed electromagnetic frequency generator (2) to be higher
`than about 3 and lower than about 1000 milliseconds.
`I0086. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of selecting the magnetic field intensity B of each pulse
`applied by said step of applying pulsed electromagnetic
`therapy to said region to be higher than about 0 and lower than
`about max magnetic field used in MRI devices (i.e., 3 Tesla).
`
`I0087. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of selecting the frequency Fapplied by the pulses applied
`by said step of applying pulsed electromagnetic therapy to
`said region to be higher than about 1 and lower than about 1M
`HZ.
`I0088. It is another object of the present invention to pro
`vide the methods as defined above, additionally comprising
`step of selecting the energy E applied by said step of applying
`pulsed electromagnetic therapy to said region to be higher
`than about 1 and lower than about 150 watts per pulse.
`I0089. It is another object of the present invention to pro
`vide the methods as defined above, wherein step of applying
`heat is applied for about 0.01 to 60 minutes.
`0090. It is another object of the present invention to pro
`vide the methods as defined above, wherein the heat and the
`pulsed electromagnetic therapy are applied simultaneously,
`sequentially or separately.
`0091. It is another object of the present invention to pro
`vide the methods as defined above, wherein said method is
`repeated 1 to 100 times in each treatment.
`0092. It is another object of the present invention to pro
`vide the methods as defined above, wherein said treatment is
`repeated more than once.
`0093. It is another object of the present invention to pro
`vide the methods as defined above, wherein said step of
`applying heat is performed by devices selected from a group
`consisting of ultrasonic diathermy, an optical device, elec
`tromagnetic induction, Sound waves emitting instrument,
`direct heat applying instrument, or from any other means of
`heating Subcutaneous tissue to temperature T.
`