(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`21 January 2010 (21.01.2010) (10) International Publication Number
`
`(43) International Publication Date
`
`WO 2010/007614 A3
`
`
`(51)
`
`International Patent Classification:
`A61N 2/00 (2006.01)
`A61N 1/40 (2006.01)
`A61N 1/32 (2006.01)
`
`(21)
`
`International Application Number:
`
`PCT/IL2009/000644
`
`(74)
`
`(81)
`
`(22)
`
`International Filing Date:
`
`29 June 2009 (29.06.2009)
`
`(25)
`
`(26)
`
`(30)
`
`(71)
`
`(72)
`(75)
`
`Filing Language:
`
`Publication Language:
`
`Priority Data:
`61/076,652
`61/112,783
`
`29 June 2008 (29.06.2008)
`10 November 2008 (10.11.2008)
`
`English
`
`English
`
`US
`US
`
`Applicant O’or all designated States except US): VENUS
`TECHNOLOGIES LTD [IL/IL];
`38 Ha'Barzel St,
`69710 Tel Aviv (IL).
`
`Inventors; and
`Inventors/Applicants (for US only): RON EDOUTE,
`Oded [IL/IL]; 14A Josef Milo St., 69643 Tel Aviv (IL).
`RON EDOUTE, Orit [IL/IL]; 14A Josef Milo St., 69643
`Tel Aviv (IL). KREMIN, Itzhak [IL/IL]; 7 Remez St.,
`53242 Givatayim (IL). POLYAKOV, Vadim [IL/IL]; 38
`Henrieta Sold St., 49532 Petach Tikva (IL).
`
`Agent: DR. EYAL BRESSLER LTD.; 11 Tuval St.,
`52522 Ramat Gan (IL).
`
`Designated States (unless otherwise indicated, for every
`kind ofnational protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
`CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO,
`DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
`HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP,
`KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD,
`ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI,
`NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD,
`SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT,
`TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`(84)
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ,
`TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE,
`ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV,
`MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, TR),
`OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML,
`MR, NE, SN, TD, TG).
`Declarations under Rule 4.17:
`
`as to applicant’s entitlement to apply for and be granted
`a patent (Rule 4.17(ii))
`
`[Continued on nextpage]
`
`(54) Title: AN ESTHETIC APPARATUS USEFUL FOR INCREASING SKIN REJUVENATION AND METHODS THEREOF
`
`Power supply and control
`system
`
`
`
`
`
`Pulsed electromagnetic
`frequency generator
`
`Tissue heating apparatus
`
`Ix)
`
`Tissue
`
`
`
`(57) Abstract: The present invention provides a system for increasing skin rejuvenation of a region of a patient's skin comprising
`a pulsed electromagnetic field (PEMF) frequency generator for constantly providing electromagnetic pulses to said region of a pa-
`tient's skin and a deep tissue diathermy device for constantly applying heat to said region of a patient's skin up to temperature T.
`The system is adapted for simultaneously applying heat and PEMF to theregion of a patient's skin,- wherein application of the sys-
`tem increases skin rejuvenation such that the skin rejuvenation increase (SRI) is greater than the sum of the SRI provided by elec—
`tromagnetic pulses increase and the SRl provided by the deep tissue diathermy device increase.
`
`
`
`W02010/007614A3|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`

`

`WO 2010/007614 A3 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`Published:
`
`— with international search report (Art. 21(3))
`— before the expiration of the time limitfor amending the
`claims and to be republished in the event of receipt of
`amendments (Rule 48.2(h))
`
`(88) Date of publication of the international search report:0
`6 May “010
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`
`CLASSIFICATION OF SUBJECT MATTER
`iNv. A61N2/OO
`A61N1/32
`
`A61N1/40
`
`International application No
`
`PCT/IL2009/000644
`
`According to international Patent Classification (IPC) or to both national classification and lPC
`B. FIELDS SEARCHED
`
`Minimum documentation searched (classification system followed by classification symbols)
`A61N
`
`Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched
`
`Electronic data base consulted during the international search (name of data base and, where practical, search terms used)
`
`EPO—Internai,,WPI Data
`
`C. DOCUMENTS CONSIDERED TO BE RELEVANT
`
`Category‘
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`DE 33 40 974 A1 (KRAUS WERNER DIPL PHYS
`KRAUS WERNER DIPL PHYS [DE])
`23 May 1985 (1985—05—23)
`abstract
`
`page 4,
`
`line 4 — page 10,
`
`line 16
`
`GB 2 188 238 A (VMEI LENIN NIS VMEI LENIN
`N15 [86]) 30 September 1987 (1987—09—30)
`abstract
`
`page 2, paragraph 25 — paragraph 53
`
`US 2006/293719 A1 (NAGHAVI MORTEZA [US])
`28 December 2006 (2006—12—28)
`paragraph [0048]
`paragraph [0068]
`
`1,4~18,
`24—28
`
`2,3,
`19-23
`
`2,3
`
`Further documents are listed in the continuation of Box C.
`
`See patent family annex.
`
` Relevant to claim No.
`
`* Special categories of cited documents :
`
`"A" document defining the general state of the art which is not
`considered to be of particular relevance
`"E" earlier document but published on or afterthe international
`filing date
`"i." document which may throw doubts on priority claim(s) or
`which is cited to establish the publication date of another
`citation or other special reason (as specified)
`"0" document referring to an oral disclosure. use, exhibition or
`other means
`
`"P“ document published prior to the international
`iaterthan the priority date claimed
`Date of the actual completion of the international search
`
`tiling date but
`
`5 November 2009
`
`"T" later document published atterthe international tiling date
`or priority date and not in conflict with the application but
`cited to understand the principle or theory underlying the
`invention
`
`"X" document of particular relevance; the claimed invention
`cannot be considered novel or cannot be considered to
`Involve an Inventive step when the document IS taken alone
`"Y" document of particular relevance; the claimed invention
`cannot be considered to involve an inventive step when the
`document is combined with one or more other such docu»
`ments, such combination being obvious to a person skilled
`In the art.
`"88' document member of the same patent family
`Date of mailing of the international search report
`
`Name and mailing address of the lSA/
`European Patent Office, PB. 5818 Patentlaan 2
`NL — 2280 HV Hijswijk
`Tel. (+31 ~70) 340—2040,
`Fax: (+31—70) 340—3016
`Beck, Ewa
`
`Form PCT/lSAl21O (second sheei) (April 2005)
`
`23/03/2010
`Authorized officer
`
`

`

`INTERNAHONALSEARCHREPORT
`
`
`C(Confinuation). DOCUMENTS CONSIDERED TO BE RELEVANT
`
`International application No
`
`PCT/IL2009/000644
`
`Category“
`
`Citation of document, with indication, where appropriate, of the relevant passages
`
`Relevant to claim No.
`
`US 2005/187599 A1 (SHARKEY HUGH [US] ET
`AL) 25 August 2005 (2005—08-25)
`abstract
`
`paragraph [0059] — paragraph [0068]
`
`NO 93/12835 A (FREE WORLD TRUST [US];
`DROLET ROLAND A [CA1)
`8 July 1993 (1993—07—08)
`abstract; figure 2k
`
`US 2004/034346 A1 (STERN ROGER A [US] ET
`AL) 19 February 2004 (2004—02—19)
`abstract
`
`paragraph [0075] — paragraph [0078]
`paragraph [0089] — paragraph [0093]
`
`no 00/53113 A (THERMAGE INC [US]; STERN
`ROGER [US]) 14 September 2000 (2000-09—14)
`abstract
`
`page 8, Tine 29 — page 9, Tine 31
`page 28, Iine 26 — page 30,
`line 3
`
`DE 38 25 165 A1 (KASTL ELECTRONIC GMBH &
`CO KG [DE]) 25 January 1990 (1990—01—25)
`c1a1m 1
`
`19,21,22
`
`
`
`GB 304 587 A (ABRAHAM ESAU)
`13 March 1930 (1930—03—13)
`c1a1m 1
`page 2, Tine 37 ~ Tine 45
`
`NO 2009/047628 A (ENDYMION MEDICAL LTD
`[IL]; LISCHINSKY DANIEL [IL]; HARTH YORAM
`[IL] EN) 16 Apri] 2009 (2009—04—16)
`the whoIe document
`
`
`Form PCT/lsA/21D (continuation of second sheet) (Apnl 2005)
`
`

`

`INTERNATIONAL SEARCH REPORT
`
`
`lntemational application No.
`
`
`PCT/ IL12009/000644
`
`
`Box No. II Observations where certain claims were found unsearchable (Continuation of item 2 of first sheet)
`
`
`
`This international search report has not been established in respect of certain claims under Article 17(2)(a) for the following reasons:
`
`Ruie 39.1(iv)
`surgery
`
`PCT — Method for treatment of the human or animal body by
`
`
`77‘99
`29—55
`Claims Nos.:
`because they relate to subject matter not required to be searched by this Authority, namely:
`
`
`
`
`
`
`
`Claims Nos.:
`because they relate to parts of the international application that do not comply with the prescribed requirements to such
`an extent that no meaningful international search can be carried out. specifically:
`
`
`
`
`
`Claims Nos.:
`
`because they are dependent claims and are not drafted in accordance with the second and third sentences of Rule 6.4(a).
`
`
`This international Searching Authority found multiple inventions in this international application, as follows:
`
`Box No. lll Observations where unity of invention is lacking (Continuation of item 3 of first sheet)
`
`
` see additionai sheet
`
` As all required additional search fees were timely paid by the applicant, this international search report covers all searchable
`
`
`claims.
`
` As all searohable claims could be searched without effortjustiiying an additional fees, this Authority did not invite payment of
`additional fees.
`
` 8. D As only some of the required additional search fees were timely paid by the applicant, this international search report covers
`
`
`only those claims for which fees were paid, specifically claims Nos.:
`
` No required additional search tees were timely paid by the applicant. Consequently, this international search report is
`
`restricted to the invention first mentioned in the claims; it is covered by claims Nos.:
`
` see annex
`
`
`
`
`
` I: No protest accompanied the payment of additional search fees.
`
`Remark on Protest
`
`I: The additional search fees were accompanied by the applicant’s protest and, where applicable, the
`payment of a protest fee.
`
`E] The additional search fees were accompanied by the applicant's protest but the applicable protest
`fee was not paid within the time limit specified in the invitation.
`
`Form PCT/ISA/210 (continuation of first sheet (2)) (April 2005)
`
`

`

`A system adapted to increase skin rejuvenation of a region
`of a patient’s skin,
`the system comprising a pulsed
`electromagnetic field (PEMF) frequency generator and a deep
`tissue diathermy device,
`the system being adapted for
`simultaneously applying heat and PEMF to the region of
`patient skin. The system additionally comprises a control
`system adapted to monitor physical
`tissue parameters and
`change the applied heat and electromagnetic pulses
`accordingly.
`
`2. claims: 56—76
`
`An integrated system adapted to increase skin rejuvenation
`of a region of a patient’s skin,
`the system comprising at
`least two electrodes adapted to be placed on the region of
`patient’s skin; each of the electrodes being at least
`partially coiled via a coil; wherein each of the electrodes
`is adapted for both providing electromagnetic pulses to the
`region of patient’s skin and applying heat up to temperature
`
`FURTHER INFORMATION CONTINUED FROM PCT/ISA, 210
`
`International Application No. PCT/ILZOOQ /000644
`
`This International Searching Authority found multiple (groups of)
`inventions in this international application, as follows:
`
`1. claims: 1—28
`
`T to the region of patient’s skin.
`
`

`

`INTERNAHONALSEARCHREPORT
`Information on patent family members
`
`Patent document
`cited in search report
`
`Publication
`date
`
`
`DE 3340974
`A1
`
`23—05—1985
`
`
`
`
` International application No
`
`
`PCT/IL2009/000644
`
`Publication
`Patent family
`
`date
`member(s)
`
`
`
`
`
`
`
`
`
`3153493
`28-07—1993
`CA
`2058179 A1
`21-06-1993
`
`
`GB
`2277270 A
`26—10-1994
`
`
`5620463
`15—04—1997
`
`
`
`
`
`
` 0053113
`14—09—2000
`AT
`298536 T
`15-07-2005
`AU
`779100 32
`06-01—2005
`
`
`
`
`CA
`2364098 A1
`14~09—2000
`DE
`60021063 D1
`04-08-2005
`
`
`DE
`60021063 T2
`11-05—2006
`
`
`EP
`1158919 A1
`05—12—2001
`
`
`ES
`2240078 T3
`16—10-2005
`
`
`JP
`4102031 32
`18—06—2008
`
`
`JP
`2002537939 T
`12-11-2002
`
`
`US
`6413255 B1
`02—O7~2002
`
`
`
`
`
`Form PCT/ISA/210 (patent family annex) (Aprll 2005)
`
`

`

`(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`
`(19) World Intellectual Property Organization
`International Bureau
`
`21 January 2010 (21.01.2010) (10) International Publication Number
`
`(43) International Publication Date
`
`WO 2010/007614 A2
`
`
`(51)
`
`International Patent Classification:
`A61N 2/00 (2006.01)
`A61N 1/40 (2006.01)
`A61N 1/32 (2006.01)
`
`(21)
`
`International Application Number:
`
`PCT/IL2009/000644
`
`(74)
`
`(81)
`
`(22)
`
`International Filing Date:
`
`Filing Language:
`
`Publication Language:
`
`29 June 2009 (29.06.2009)
`
`English
`
`English
`
`Priority Data:
`61/076,652
`61/112,783
`
`29 June 2008 (29.06.2008)
`10 November 2008 (10.11.2008)
`
`US
`US
`
`(84)
`
`Applicant O’or all designated States except US): VENUS
`TECHNOLOGIES LTD [IL/IL];
`38 Ha'Barzel St.,
`69710 Tel Aviv (IL).
`
`(25)
`
`(26)
`
`(30)
`
`(71)
`
`(72)
`(75)
`
`Agent: DR. EYAL BRESSLER LTD.; 11 Tuval St.,
`52522 Ramat Gan (IL).
`
`Designated States (unless otherwise indicated, for every
`kind ofnational protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ,
`CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO,
`DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT,
`HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP,
`KR, KZ, LA, LC, LK, LR, Ls, LT, LU, LY, MA, MD,
`ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI,
`NO, NZ, OM, PE, PG, PH, PL, PT, RO, RS, RU, SC, SD,
`SE, SG, SK, SL, SM, ST, SV, SY, TJ, TM, TN, TR, TT,
`TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW.
`
`Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GH,
`GM, KE, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ,
`TM), European (AT, BE, BG, CH, CY, CZ, DE, DK, EE,
`ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV,
`MC, MK, MT, NL, NO, PL, PT, RO, SE, SI, SK, TR),
`OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, ML,
`MR, NE, SN, TD, TG).
`
`Inventors; and
`Inventors/Applicants (for US only): RON EDOUTE,
`Oded [IL/IL]; 14A Josef Milo SL, 69643 Tel Aviv (IL).
`RON EDOUTE, Orit [IL/IL]; 14A Josef Milo St., 69643
`Tel Aviv (IL). KREMIN, Itzhak [IL/IL]; 7 Remez St.,
`53242 Givatayim (IL). POLYAKOV, Vadim [IL/IL]; 38 Dedarations under Rm" 4-17:
`Henrieta Sold St., 49532 Petach Tikva (IL).
`as to applicant’s entitlement to apply for and be granted
`a patent (Rule 4.17(ii))
`
`(54) Title: AN ESTHETIC APPARATUS USEFUL FOR INCREASING SKIN REJUVENATION AND METHODS THEREOF
`
`[Continued on nextpage]
`
`(57) Abstract: The present invention provides a sys-
`tem for increasing skin rejuvenation of a region of a
`patient's skin comprising a pulsed electromagnetic
`field (PEMF) frequency generator for constantly pro-
`viding electromagnetic pulses to said region of a pa-
`tient's skin and a deep tissue diathermy device for
`constantly applying heat to said region of a patient's
`skin up to temperature T. The system is adapted for
`simultaneously applying heat and PEMF to theregion
`of a patient's skin; wherein application of the system
`increases skin rejuvenation such that theskin rejuve-
`nation increase (SRI) is greater than the sum of the
`SRI provided by electromagnetic pulses increase and
`the SRI provided by the deep tissue diathermy device
`increase.
`
`Power supply and control
`system
`
`Pulsed electromagnetic
`frequency generator
`
`Tissue heating apparatus
`
`
`
`FIG. 2
`
`
`
`W02010/007614A2|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`

`

`WO 2010/007614 A2 |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`Published:
`
`— without international search report and to be republished
`upon receipt ofthot report (Rule 48.2(g))
`
`

`

`WO 2010/007614
`
`PCT/IL2009/000644
`
`AN ESTHETIC APPARATUS USEFUL FOR INCREASING SKIN REJ U VENATION
`
`AND METHODS THEREOF
`
`FIELD OF THE INVENTION
`
`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 ‘
`
`.
`
`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 chemical and physical
`
`injuries, such as tobacco, cosmetics, esthetics and
`
`radiation from the sun and other sources. Those factors contribute to the decrease in collagen
`production, to reduced elasticity, and the appearance of wrinkles.
`
`A few main approaches to tightening of the skin are common practice today. The surgical
`
`approach carries disadvantages related to the anesthesia, the surgical complications, and the
`
`healing process,pwhich 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 subcutaneous layer of the skin, and since heat
`
`was shown to contract these fibers and generate their production [Zelickson BD, Kist D,
`
`Bernstein E, Brown DB, Ksenzenko S, Burns J, Kilmer S, Mehregan D, Pope K. Histological
`
`and ultrastructural evaluation of the effects of a radiofrequency-based nonablative dermal
`
`remodeling device: a pilot study. Arch Dermatol. 2004 Feb;140(2):204-9], methods of
`
`differentially heating the dermis (deep tissue diathermy) have recently arisen.
`
`A unique method of treating the dermis is called Pulsed Electromagnetic Fields (PEMF)
`
`therapy. This method usually employs electromagnetic radiation of different frequencies -
`
`ranging from static magnetic fields, through extremely low frequencies (ELF) to higher
`
`radiofrequencies (RF) — administered in pulses.
`
`PEMF works in few ways. Due to the radiation absorbed in the tissue, it can be heated to
`
`various temperatures, depending on the power applied, the frequency transmitted, and more
`
`importantly the tissue characteristics. Eventually, the tissue can be warmed to denaturation
`
`temperatures, which cause coagulation necrosis and tiSSue damage. It can also be heated to
`
`

`

`WO 2010/007614
`
`PCT/IL2009/000644
`
`lower temperatures, which proved to result in the afore—mentioned contraction of collagen
`
`fibers.
`
`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.
`
`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.
`
`It is now commonly accepted that weak electromagnetic fields (EMF) administered in pulses
`
`are capable of initiating various healing processes in fractures, multiple sclerosis 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.
`
`Bioelectromagnetic Medicine, Marcel Dekker, NY, 251— 264].
`
`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 viva trials
`
`showed that pulsed electromagnetic field of certain field intensities and frequencies increased
`
`epidermal collagen synthesis [Ahmadian S, Zarchi SR, Bolouri B. Effects of extremely-low—
`
`-frequency pulsed electromagnetic fields on collagen synthesis in rat skin. Biotechnol Appl
`
`Biochem. 2006 Feb;43(Pt 2):71-5]. This new formed collagen increases skin elasticity and
`
`rejuvenates its appearance.
`
`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 OM et al.
`
`Electromagnetic fields increase in Vitro and in vivo angiogenesis through endothelial release
`
`of FGF-2. FASEB J. 2004 Aug;18(ll)2123l—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
`
`

`

`WO 2010/007614
`
`PCT/IL2009/000644
`
`injured tissue, promoting rapid and improved healing. The growth factor released further
`
`enhances the healing process, both in quality and time of improvement.
`
`The scientific evidence of the effect of PEMF on tissues was utilized in Various applications.
`
`For example, U820050182462A1 discloses healthy deep tissue heating using PEMF for the
`
`purpose of causing contraction and tightening of the skin.
`
`PEMF has also been used to improve skin wound healing. For example, W008064272
`
`discloses a method of treating a severe diabetic ulcer using PEMF. The patent also discloses
`
`the addition of intermittent compression therapy (1CT) and the use of low intensity ultrasound
`
`(up to 50 W/cmz), the latter aimed at inhibiting microbial growth.
`
`Other methods of heating the dermis used non pulsating RF radiation, applied by antenna or
`
`electrodes. 'For example, WO98005380 discloses a method of tightening skin using an RF
`
`electromagnetic energy delivery device.
`
`‘
`
`Improving the results of skin tightening based on dermis diathermy is still a long felt need,
`
`both for esthetic and therapeutic purposes.
`
`SUMMARY OF THE INVENTION
`
`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
`
`a.
`
`b.
`
`a pulsed electromagnetic field (PEMF) frequency generator (2) for constantly
`
`providing electromagnetic pulses to said region of a patient's skin; and,
`
`a deep tissue diathermy device (4) for constantly 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 application of said system increases said skin rejuvenation such that”
`
`said skin rejuvenation increase (SR1) is greater than the sum of said SR1 provided by
`
`electromagnetic pulses increase and said SR1 provided by said deep tissue diathermy device
`
`increase.
`
`'It is another object of the present invention to provide the system as defined above, wherein
`
`said electromagnetic pulse is a triangular shaped at frequency of 25 Hz and intensity of 20
`
`Gauss.
`
`It is another object of the present invention to provide the systemas defined above, wherein
`
`said electromagnetic pulse is square shaped at a frequency of 16 Hz, duration of about 5
`
`milliseconds and intensity of 12 Gauss.
`
`

`

`WO 2010/007614
`
`.
`
`.
`
`PCT/IL2009/000644
`
`It is another object of the present invention to provide 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 current absorbed by subcutaneous tissue.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said deep tissue diathermy device (4) additionally comprises:
`
`a.
`
`b.
`
`'
`
`.
`
`at least one electrical output device adapted to generate RF electromagnetic
`
`energy;
`
`at least two electrodes electrically coupled to said electrical output device and
`
`placed on said skin region, wherein all said electrodes are adapted to
`
`simultaneously apply said RF energy to said skin region.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said deep tissue diathermy device (4) additionally comprises:
`
`a.
`
`b.
`
`at least one electrical output device adapted to generate electrical current;
`
`at least two electrodes electrically coupled to said electrical output device and
`
`placed on said skin region, wherein all said electrodes are adapted to
`
`simultaneously apply said electrical current to said skin region.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said system. reduces side effects and/or harmfiil effects of said electromagnetic 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 electromagnetic pulses and/or said
`
`reduction of said deep tissue diathermy.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said system additionally comprising a control
`
`system (6) adapted to regulate said
`
`electromagnetic pulses and/or said electromagnetic pulses.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said pulsed electromagnetic frequency generator is adapted to provide a dynamic magnetic
`
`field such that said electromagnetic pulses vary with time.
`
`It- is another object of the present invention to provide 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 triangular wave, sawtooth wave, ramp waves,
`
`spiked wave or any other mathematical combination.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`the magnetic field intensity B of each pulse applied by said pulsed electromagnetic frequency
`
`generator (2) ranges between about 0 and about 3 Tesla.
`
`

`

`WO 2010/007614
`
`PCT/IL2009/000644
`
`It is another object of the present invention to provide 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 milliseconds.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`the frequency F applied by the pulses of said pulsed electromagnetic frequency generator (2)
`
`ranges between about 1 Hz and about lMfiHz.’
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`the energy E applied by the pulses of said pulsed electromagnetic frequency generator (2)
`
`ranges between about 1 and about 150 watts per pulse.
`
`.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said deep tissue diathermy device (4) is selected in a non—limiting mannerfrom 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.
`.It is another object of the present invention to provide the system as defined above, wherein
`
`said optical device is adapted to emit light in wavelengths absorbed by subcutaneous tissue
`
`such that said subcutaneous tissue is heated.
`
`It is another object of the present invention to provide 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.
`
`It is another object of the present invention to. provide the system as defined above, wherein
`
`said temperature T is higher than about 30 and lower than about 80 degrees.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said power supply and control system (6) monitors physical tissue parameters and changes
`
`applied heat and electromagnetic pulses accordingly.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said power supply and control system (6) additionally comprising: '
`
`a.
`
`processing means, adapted to store in a communicable database predetermined .
`
`parameters defining (z) safe treatment parameters and (it) unsafe treatment
`
`. parameters; said parameters are selected from a group consisting of time t of
`
`said treatment, 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
`
`

`

`WO 2010/007614
`
`PCT/IL2009/000644
`
`impedance, specific absorption rate (SAR), treatment depth, superficial muscle
`
`contractions or a combination thereof; .
`
`b.
`
`sensing means; adapted to sense electromagnetic radiation and heat radiation
`
`parameters selected from a group consisting of time t of time t of said
`
`treatment,
`
`temperature T of said tissue, ratio t/T, Frequency F, power P,
`
`Intensity I of said ultrasound 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;
`
`0.
`
`regulating means, adapted to allow said electromagnetic radiation and heat
`
`radiation if said parameters are within said safe treatment parameters and to
`
`stop the electromagnetic radiation if the radiation parameters are in said unsafe
`
`treatment parameters.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said power supply and control system (6) includes a mechanism for skin cooling.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said system (10) is encased in at least one platform.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said pulsed electromagnetic frequency generator (2) and said deep tissue diathermy device (4)
`have more than one applicator to treat more than one body part simultaneously.
`
`It is another object of the present invention to provide the system as defined above, wherein
`
`said pulsed electromagnetic frequency generator (2) has electrostatic shielding.
`
`It is another object of the present invention to provide the system as defined above, especially
`adapted to increase skin rejuvenation in the immediate (short) range.
`I
`
`It is another object of the present invention to provide the system as defined above, especially
`
`adapted to increase skin rejuvenation in the intermediate range.
`
`It is another object of the present invention to provide the system as defined above, especially
`
`adapted to increase skin rejuvenation in the long.range.~
`
`It is another object of the present invention to provide 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.
`
`

`

`WO 2010/007614
`
`PCT/IL2009/000644
`
`It is another object of the present invention to provide a method (400) of increasing skin
`
`rejuvenation of a region of a patient's skin. The method comprises steps selected inter alia
`
`from:
`
`a.
`
`b.
`
`c.
`
`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;
`
`and,
`
`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 electromagnetic
`
`therapy to said region increase.
`
`It is another object of the present invention to provide a method (410) of increasing skin
`
`' rejuvenation of a region of a patient's skin. The method comprises steps selected inter alia
`
`from:
`
`a.
`
`b.
`
`c.
`
`obtaining (i) pulsed electromagnetic frequency generator; and, (ii) a deep
`
`tissue diathermy device;
`
`applying pulses of electromagnetic field to said region; and,
`
`applying heat to a subcutaneous tissue within said region up to temperature T;
`
`wherein said increasing of s