(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(19) World Intellectual Property
`Organization
`International Bureau
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`UN ANICM ATTAUTAAAAA
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`\=z
`=
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`(10) International Publication Number
`WO 2014/009875 A2
`(43) International Publication Date
`16 January 2014 (16.01.2014) WIPO! PCT
`
`
`(GD)
`
`@2)
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`International Patent Classification: Not classified
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`International Application Number:
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`PCT/IB2013/055625
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`(22)
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`International Filing Date:
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`(25)
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`(26)
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`(39)
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`(71)
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`(72)
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`(74)
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`(81)
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`Filing Language:
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`Publication Language:
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`9 July 2013 (09.07.2013)
`
`English
`
`English
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`Priority Data:
`61/669, 187
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`9 July 2012 (09.07.2012)
`
`US
`
`[NL/NL];
`Applicant: KONINKLIJKE PHILIPS N.V.
`High Tech Campus 5, NL-5656 AE Eindhoven (NL).
`
`Inventors: HORTON, Margaret, Ruth; c/o High Tech
`Campus Building 5, NL-5656 AE Eindhoven (NL).
`JURNA, Martin; c/o High Tech Campus Building 5, NL-
`5656 AE Eindhoven (NL). PALERO, Jonathan, Alam-
`bra; c/o High Tech Campus Building 5, NL-5656 AE
`Eindhoven (NL).
`
`Agents: COOPS,Peter et al.; Philips Intellectual Property
`& Standards, P.O. Box 220, NL-5600 AE Eindhoven (NL).
`
`Designated States (unless otherwise indicated, for every
`kind of national protection available): AE, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY,
`BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM,
`
`DO, DZ, EC, EE, EG, ES, Fl, GB, GD, GE, GH, GM, GT,
`HN, HR, HU,ID, IL, IN, IS, JP, KE, KG, KN, KP, KR,
`KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, ME,
`MG, MK, MN, MW, MX, MY, MZ, NA, NG, NL NO, NZ,
`OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SC,
`SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, 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, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ,
`UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ,
`TM), European (AL, AT, BE, BG, CIT, 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. RS, SE, SI. SK, SM,
`TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW,
`KM, 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))
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`as to the applicant's entitlement to claim the priority of the
`earlier application (Rule 4.17/(iii))
`Published:
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`without international search report and to be republished
`upon receipt ofthat report (Rule 48.2(g))
`
`(54) Title: SKIN TREATMENT METHOD AND APPARATUS
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`
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`FIG. 3
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`(57) Abstract: A method oftreating a skin tissue area (3) having a skin surface (5) is provided. The method comprisesthe steps of:
`deforming the skin tissue area into a deformed shape comprising a plurality of folds (17) in the skin tissue area; arranging radiofre-
`quencyelectrodes (13) in contact with the skin surface on opposite sides of the deformed skin tissue area; and, while maintaining the
`skin tissue area in said deformed shape, providing a spatially continuous radiofrequency energy flow between the radiofrequency
`electrodes on opposite sides of the deformed skintissue area through the deformed skintissue area, thereby heating at least a portion
`(19) of the deformed skin tissue area; and releasing the skin tissue area from said detormed shape, thereby detorming said heated
`portion (19) into a wave- shaped zoneof heated skin tissue having a depthrelative to the skin surface that varies between a minimum
`and a maximum value in a direction between said opposite sides. Accordingly, an apparatus for treating a skin tissue area (3) is
`provided.
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`
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`2014/009875A2[IINIIMITINATANINIIAUMNTAINATA
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`©=
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`WO 2014/009875
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`PCT/1B2013/055625
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`Skin treatment method and apparatus
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`FIELD OF THE INVENTION
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`The present disclosure relates to treatment of skin tissue with radiofrequency
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`(RF) energy,e.g. for rejuvenation, and in particular to fractional RF treatment.
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`wn
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`BACKGROUND OF THE INVENTION
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`Radiofrequency (RF) is a commonly used technology to heat skin tissue to
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`treat wrinkles and skin laxity.
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`For skin tightening, RF is used to heat below the surface of the skin to contract
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`collagen. Dermal collagen contracts whenit is heated at temperatures between 60°C and
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`10
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`70°C, and it denatures at higher temperatures, depending upon the duration of the applied
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`heat. The shrinkage of the tissuc can reach tens of percents of the hcated tissue volume, and
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`15
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`20
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`25
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`results in tightening of the skin.
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`A major disadvantage of the prior art for skin treatments based on uniform
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`heating is that there is a high risk of pain and healing complications.
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`Fractional or pixelated treatment systems are known, which aim to provide
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`that injured tissue is surrounded by non-injured tissue to promote healing and reduce pain,
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`downtime and risks. US 2006/0047281 discloses an example of the use of multi-electrode RF
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`treatment systems, where an electrode is distributed into several elements to heat discrete
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`volumes.
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`Fractional devices in the prior art are not able to selectively treat small
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`localized areas of skin without the use of complex, multiple and relatively small electrode
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`configurations. Also, they are in general not able to non-ablatively treat skin, causing related
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`pain andthe risk of complications.
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`Improvements in RF treatment of skin are therefore desired.
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`SUMMARY OF ‘THE INVENTION
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`A methodof treating a skin tissue area having a skin surface according to the
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`appendedclaims is provided. ‘The method comprises the steps of: deforming the skin tissue
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`area into a deformed shape comprising a plurality of folds in the skin tissue area; arranging
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`radiofrequency (RF) electrodes in contact with the skin surface on opposite sides of the
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`deformed skin tissuc area; and, while maintaining the skin tissue area in said deformed shape,
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`providing a spatially continuous radiofrequency (RI’) energy flow between the
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`radiofrequency electrodes on opposite sides of the deformed skin tissue area through the
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`deformed skin tissue area, and releasing the skin tissue area from said deformed shape,
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`thereby deforming said heated portion into a wave-shaped zone of heated skin tissue having a
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`depth relative to the skin surface that varies between a minimum and a maximum value in a
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`direction between said opposite sides.
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`The folds can be any type of undulation or corrugation of the skin tissue,
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`10
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`ranging from smoothly varying ripples having a numberofprotrusions and depressionsin
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`between to one or more fully closed folds with skin tissue surface portions on opposite sides
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`of the fold touching each other.
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`Thus, a temperature profile having an oscillating depth variation relative to the
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`surface of the skin tissue area is provided and a pattern of surface heated zones and a pattern
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`15
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`of deeper tissue heated zones are created in an efficient manner. The wavelike pattern of
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`thermal zoncsin the skin tissuc arca is provided in a controllable manner using only two
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`skin-contact electrodes. This facilitates treatment. Further, by using skin manipulation to
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`distribute the energy between the dermis and epidermis, leaving certain tissue zones
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`untreated, the resulting tissue injury is also distributed and the presence of untreated tissue
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`20
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`promotes healing of injured tissue. By adjustment of the amplitude and/or “wavelength” of
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`the skin tissue folds, the treatment depth can be adjusted, e.g. by determination and possible
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`adjustment of height differences between adjacentrelative protrusions and depressions. For
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`increased accuracy, such determination may take further reference to the relief of the skin
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`tissue area prior to deformation and/or un-deformed skin tissue portions adjacent the
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`deformedskin tissue area. A suitable apparatus for performing the method may comprise a
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`profilometer coupled with a memory for storing reference data and a controller for comparing
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`measurement data with stored reference data.
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`In a particular embodiment, the skin tissue area comprises an epidermis layer
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`and a dermis layer, and an amplitude of at least part of the folds is arranged such thatat least
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`30
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`a part of the path defined by the spatially continuous flow of radiofrequency energy between
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`the radiofrequency electrodes and through the deformed skin tissue area extends through a
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`portion of the dermis layer. Thus, the heating pattern extends through the epidermis and
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`dermis that connect through the dermal-epidermal junction. Whenthe treatment is directed
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`also to both the dermis and the epidermal-dermal junction, then the RF treatment can also
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`target pigmentation and induce skin textural changes through neocollagenesis. Heating the
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`dermis can initiate such ncocollagenesis and/or neoclastogcenesis, heating the cpidcrmal-
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`dermal junction can stimulate the melanocytes and basal cell layer, and heating the epidermis
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`can incite a healing response and also target pigmentation. As a result, skin rejuvenation and
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`tightening may be improved.
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`With regard to the dermis, the main disadvantage of the known methods and
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`devices relying on uniform dermal heating is that the heating is difficult to control. In
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`particular for mono-polar and bipolar RF configurations, the time for heating the tissue can
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`be in the millisecond range and the heat immediately dissipates into the surroundingtissue.
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`10
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`Overheating can lead to patient discomfort, burns and fat atrophy. The presently provided
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`method overcomes such disadvantage by dispersing the heat in the dermis into local
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`treatment zones, providing slow heating of the dermis compared to known uniform heating
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`systems, which allows for more control.
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`The step of providing the spatially continuous radiofrequency energy flow
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`15
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`between the radiofrequency electrodes and through the deformed skin tissue area may
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`comprise heating at least a portion of the deformed skin tissuc areca to a temperature above
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`about 60 degrees Celsius.
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`Dermal collagen contracts whenit is heated to temperatures between 60°C and
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`70°C, and it denatures at higher temperatures, which effect can depend on the duration of the
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`20
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`applied heat. The shrinkage of the tissue can reach tens of percents of the heated tissue
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`volume, and results in tightening of the skin. To prevent denaturation and/or necrosis, the
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`skin tissue area may be heated to a temperature in a range of 60-70 degrees Celsius, and
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`heating to a higher temperature can be prevented.
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`‘The step of deforming the skin tissue area into a deformed shape comprises
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`deforming at least a portion of the skin tissue area using a mechanical deformer. Use of a
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`mechanical deformer, e.g. a compression device, facilitates providing and/or maintaining a
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`desired deformed shapereliably, also over prolonged and/orrepetitive application of the
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`method. Such a method maysuitably comprise pressing a mask into a portion of the skin
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`tissue area, compressing at least two portions of skin tissue towards each other and/or
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`30
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`applying vacuum suctionto at least part of the skin tissue area, so that the skin may be
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`deformed in different ways and according to a desired pattern. ‘he mask suitably comprises a
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`pattern of protrusions corresponding to the plurality of folds to be formed into the skin tissue
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`area, and application of vacuum suction suitably comprises applying vacuum suction to one
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`or more vacuum chambers corresponding to the plurality of folds to be formed in contact
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`with the skin tissuc arca.
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`In an embodiment, the step of deforming the skin tissue area is performed by
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`engaging the skin tissue with the radiofrequency electrodes, in particular by bringing the skin
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`surface in frictional contact with the radiofrequency electrodes, and displacing the electrodes
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`towards each other, which facilitates arrangement of the electrodes around the deformed skin
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`tussue to be treated. In a particular embodiment, the RF electrodes may be hand-held by a
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`person performing the treatment, e.g. with RF electrodes imbeddedinto the fingers of a
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`flexible glove, allowing simultaneous skin manipulation and RF treatment.
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`10
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`The method may further compriseat least one of the steps of dermabrasion,
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`microdermabrasion, the application of microlesions and outer skin layer resurfacing to
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`promote rejuvenation of the skin tissue.
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`In accordance with the above, in an aspect, an apparatus for treating a skin
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`tissue area having a skin surface is provided. The apparatus comprises a skin tissue deformer
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`15
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`configured to form the skin tissue area into a deformed shape comprising a plurality of folds
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`in the skin tissue area and to maintain the skin tissue area in the deformed shape, and a
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`numberofradiofrequency (RE) electrodes, configurable to be in contact with the skin surface
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`on opposite sides of the deformed skin tissue area. The apparatus is configured for applying,
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`while maintaining the skin tissue area in said deformed shape, a spatially continuous
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`20
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`radiofrequency (RF) energy flow between the radiofrequency electrodes on opposite sides of
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`the deformed skin tissue area through the deformed skin tissue area, and for releasing the skin
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`tissue area from said deformed shape after application of the spatially continuous
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`radiofrequency energy flow. Thereby, a portion of the deformed skin tissue area is heated
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`such that, when the skin tissue area is released from said deformed shape, said heated portion
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`is deformed into a zone of heated skin tissue having a depth variation relative to the skin
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`surface that varies between a minimum and a different maximum value in a direction
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`between said opposite sides. Thus, application of fractional RF treatmentis facilitated.
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`In a particular embodiment, the apparatus comprises a control unit configured
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`and arranged to operate the apparatus so as to form the skin tissue area into a deformed shape
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`30
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`comprising a plurality of folds in the skin tissue area, maintain the skin tissue area in the
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`deformed shape by application of the skin tissue deformer, and apply a spatially continuous
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`radiofrequency (RI") energy flow through the deformedskin tissue area by application of the
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`radiofrequency electrodes when arranged on opposite sides of the deformed skin tissue area,
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`WO 2014/009875
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`PCT/1B2013/055625
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`)
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`andrelease the skin tissue area from said deformed shape by application of the skin tissue
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`deformerafter application of the spatially continuous radiofrequency energy flow.
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`In a particular embodiment, the apparatus is configured to heat at least a
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`portion of the deformed skin tissue area to a temperature above about 60 degrees Celsius to
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`LS
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`cause contraction and/or denaturation of collagen for tightening ofthe skin tissue and/or
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`inciting rejuvenation. Preferably, the heating is performed to a temperature in a range of
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`about 60-70 degrees Celsius.
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`The apparatus may comprise a controller configured to operate the apparatus
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`as a function of one or more input signals, e.g. from a user interface. In an embodiment, the
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`10
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`controller may be configured to operate the deformer.
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`The apparatus may comprise a thermometer configured to detect a temperature
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`of the skin tissue area and the controller may be configured to operate the apparatus as a
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`function of one or more signals from the thermometer. This facilitates controlled operation,
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`e.g. providing safety against overheating and/or including a feedback mechanism. The
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`15
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`apparatus may also include detection of impedance of the skin to give feedback, for example,
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`on the tempcrature or the extent of heating.
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`In order to provide a controlled thermal pattern, the skin tissue deformer may
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`comprise a mask comprising a pattern of protrusions corresponding to the plurality of folds to
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`be formedinto the skin tissue area to define a plurality of adjacent skin tissue folds.
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`20
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`Alternatively, the skin tissue deformer may comprise a vacuum system comprising one or
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`more vacuum chambers corresponding to the plurality of folds to be formed for creation of
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`skin tissue folds by vacuum suction. The skin tissue deformer may be configured to provide a
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`two-dimensional array of skin tissue folds. The spacing of the mask and/or the vacuum
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`pressure mayassist in determining the depth of the skin tissue folds.
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`25
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`The skin tissue deformer may comprise a plurality of probes and/or
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`radiofrequency electrodes configured to be broughtinto frictional contact with the skin
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`surface and engagethe skin surface, and to be movable with respect to each other to thereby
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`deform the skin tissue area into the deformed shape. The probes and/or electrodes may
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`comprise surface portions providing a high coefficient of friction when in contact with
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`30
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`humanskin surface, e.g. comprising a rubber and/or roughened contact surface for contacting
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`humanskin, and/or comprising one or more vacuum cups configured to engage the skin by
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`suction. Thus, skin tissue may be pushed and/or pulled in a desired direction to fold the skin
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`tissue area. Such a deformerfacilitates maintaining a particular deformation for extended
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`periods of time non-invasively. The deformer may be adjustable to establish and/or maintain
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`6
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`a particular deformed shape. In an embodiment, the apparatus may comprise a flexible glove
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`comprising the RF clectrodes.
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`Preferably, the apparatus comprises a cooler, e.g. being configured to cool the
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`skin tissue area to a temperature at or near normal body temperature. Thus, a particular
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`thermal gradient in the skin may be provided and/or a hot feeling may be soothed.
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`The cooler may comprise a heat sink, such as a radiator with a high thermal
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`conductance and a large surface, convective cooling or chilled gas, possibly in combination
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`with a heat sink, and/or a cryogenic cooling element, but preferred is an active cooling
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`element such as a Peltier-element and/or a refrigerator device, which may be controllably
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`10
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`operated.
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`The apparatus may comprise a profilometer, e.g. to provide information on a
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`height profile of a skin tissue relief feature. The profilometer may be configured to provide
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`one or more signals, such as visual indications and/or signals to be used as input signals, to a
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`controller configured to operate the apparatus as a function of one or more signals from the
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`15
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`profilometer, e.g. for adjustment of the deformer to provide a deformation of a desired
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`amplitude and/or wavelength. The profilometer can also provide information on the progress
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`and/or effectiveness of the method. It is conceivable that a plurality of cycles of heating,
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`cooling, reheating and re-cooling are performed according to the method presented herein
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`until a particular skin tissue profile is reached.
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`20
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`The profilometer may comprise a mechanical detector, e.g. with one or more
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`mechanical probes, an electrical detector, e.g. with one or more capacitive or resistive sensors
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`and/or an optical detector, e.g. with an optical reflectance sensor, a camera etc. The
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`profilometer may be coupled with a memory and/or a controller, which may be contained in
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`the apparatus.
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`The apparatus may be configured for performing dermabrasion,
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`microdermabrasion, and for the application of microlesions and/or outer skin layer
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`resurfacing to the skin tissue area, for which purpose the apparatus comprises, e.g., a
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`mechanical skin tissue perforator, a suitable light source, an ultrasound generator etc. Such
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`apparatus facilitates inducing skin rejuvenation in addition to providing a reformed skin
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`30
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`shape to provide a smoother, younger-looking skin.
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`The apparatus may comprise a controller, possibly having a memory which
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`may be programmable, the controller being configured to operate the apparatus as a function
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`of one or more signals from a thermometer, a profilometer and/ora userinterface.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`In the drawings:
`
`~
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`Figs. 1-4 show steps of a method of treating a skin tissue area;
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`Fig. 5 is a cross sectional view of skin tissue treated with the method;
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`Fig. 6 indicates skin tissue treated with fractional RF treatment, for
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`comparison;
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`Fig. 7 is a top view of skin tissue treated with the method;
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`Figs. 8-12 are thermographsof steps of a method oftreating a skin tissue area,
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`a corresponding cartoon and a graph of a measurementresult, respectively;
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`Fig. 13 indicates an embodiment of an apparatus for treating a skin tissue area
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`as disclosed herein;
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`Figs. 14A-14F indicate mask patterns for use in embodiments of an apparatus;
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`Figs. 15A-15B indicate another embodiment of an apparatus for treating a skin
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`tissue area as disclosed herein;
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`Figs. 16A-16B indicate part of an embodiment of an apparatus with a
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`combination mask and electrode arrangement.
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`TS
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`10
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`15
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`DETAILED DESCRIPTION OF EMBODIMENTS
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`It is noted that, in the drawings, like features may be identified with like
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`20
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`reference signs. It is further noted that the drawings are schematic, not necessarily to scale
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`and that details that are not required for understanding the present invention may have been
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`omitted. The terms "upward", "downward", "below", “above”, and the like relate to the
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`embodiments as oriented in the drawings. Further, elements that are at least substantially
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`identical or that perform anat least substantially identical function are denoted by the same
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`numeral.
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`Figs. 1 and 2 show steps of the methodof treating a skin tissue area. Figs. 1
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`and 2 show in cross section an apparatus 1 for treating skin tissue, which apparatus is placed
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`on a humanskin tissue area 3. The skin tissue area 3 has a skin surface 5, an epidermis layer
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`7, a dermis layer 9 and a dermal-epidermal junction 11. Below the dermis layer 9 further
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`30
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`tissue layers are present, which are not shown. The apparatus | comprises a numberof
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`radiofrequency (RE) electrodes 13, arrangeable in contact with the skin surface 5, and a
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`powersource 15 connected with the RI’ electrodes 13 to apply RI’ energyto the skin tissue
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`area 3.
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`In this embodiment, the RF electrodes 13 are configured to be brought into
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`frictional contact with the skin surface 5, and to be movable with respect to each other
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`(indicated with the arrows in Fig. 1) to thereby deform the skin tissue area 3 between the
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`electrodes 13 from an initial shape (Fig. 1) into a deformed shape (Fig. 2) having a plurality
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`TS
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`of folds 17 in the skin tissue area 3 with relative protrusions and depressions of a desired
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`amplitude anddistance relative to each other, so that the dermal-epidermal junction 11 is
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`folded into an oscillating wavy shape (Fig. 2).
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`Fig. 3 indicates operation of the RF source 15, with the RF electrodes 13 in
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`bipolar configuration and the polarity of the electrodes being varied with respect to each
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`10
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`other, at high radiofrequency, while maintaining the skin tissue area 3 in the deformed shape.
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`The RF energy flow will take the path of least electrical resistance between the RF electrodes
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`13 which generally corresponds to the shortest geometrical path. Thus, a spatially continuous
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`radiofrequency energy flow is provided from one RF electrode 13 to the RF electrode 13 on
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`the opposite side of the deformed skin tissue area 3 through the deformed skin tissue area 3,
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`15
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`wherein the RF energyis distributed in a skin tissue zone 19 extending at varying depths with
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`respect to the skin surface 5, here also crossing the dermal-cpidermaljunction 11.The RF
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`energy is dissipated in the skin tissue zone 19 and heats it.he temperature and spatial extent
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`of the skin tissue zone 19 are related to the power and duration of the applied RF energy.
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`Fig. 4 showsthat, if (the pinching force on) the skin tissue 3 is released and
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`20
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`the folds 17 are removed, the skin tissue zone 19 that has been heated by the RF energy
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`retains its depth variation relative to the skin surface andthe skin tissue zone 19 is
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`accordingly deformed into a wave-shaped zone having a depth that varies between a
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`minimum and a different maximum valuerelative to the skin surface in a direction between
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`said opposite sides. ‘The depth profile of the heated skin tissue may be suitably determined
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`with respect to (a maximum of) the temperature profile perpendicular to the skin surface
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`and/or with respect to one or more isothermsin the skin tissue. The minimum depth value
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`may besubstantially zero and the maximum depth value may be several millimeters or even
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`over a centimeter for deep skin folds 17, e.g. on a person’s belly- or back region.
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`Fig. 5 showsthe skin tissue area 3 of Fig. 4 without the apparatus 1. Fig. 6
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`30
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`indicates an RF energy distribution, and thus the associated heating pattern, envisioned when
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`using a known fractional RF apparatus with a relatively dense electrode pattern indicated by
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`means of the bold arrows. The similarity will be striking to the skilled reader. However, as
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`set out above, the RF fields between each pairof adjacent electrodes extend generallyto little
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`depth, which depth cannot be accurately controlled. Further, fractional RF systems and the
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`use thereof are significantly more complex and delicate as compared to the present apparatus
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`and method.
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`Fig. 7 is a schematic top view of the skin surface 5 of a skin tissue area 3
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`treated with an embodimentof the presently provided method, indicating a striped pattern of
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`SS
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`heated (dark) versus cooler (light) skin tissue portions, corresponding to superficial and deep
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`portions of the heated skin tissue zone 19, respectively. The temperature of the relatively
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`superficial portions, corresponding to the bottomsof the folds 17, is indicative of the
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`temperature in the deeper regions corresponding to the maximaof the folds 17.
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`Figs. 8,9 and 11 show photographs, taken with a temperature-sensitive
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`10
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`camera, of an underarm ofa test subject. Fig. 10 is a cartoon of Figs. 8 and 9. The thermal
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`images were recorded with an PLIR infrared camera adjusted for the emissivity of human
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`skin (0.98). For this experimental system, bipolar RF electrodes were embeddedinto fingers
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`of a flexible glove, allowing simultaneous skin manipulation and RF treatment. Fig. 10 shows
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`the underarm 21, the positions of the fingers 23 and the associated electrodes 13, as well as
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`15
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`the folds 17 in the treated skin tissue area 3.
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`Fig. 8 showsskin tissue being pinched between (the fingers 22 carrying) the
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`REelectrodes, with individual folds 17 indicated with arrows, see also Fig. 10. The color
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`scale corresponds to a surface temperature range of about 29.2-33.5°C. Fig. 9 shows the
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`effect of RF being applied to the pinched area of Fig. 8 for 2.0 seconds, increasing the
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`20
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`average surface temperature between the electrodes to 33°C from about 31°C. Fig. 11 shows
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`the effect of the heating when the pinching pressure is released. Generally linear and parallel
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`portions with elevated surface temperatures of about 32.7°C have been created in between the
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`electrodes. Fig. 12 showsa line profile analysis through the heated zone as indicated in Fig.
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`11, showing the periodic surface temperature pattern created by the RF energy, comparable
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`to Fig. 7. This allows controlling the operation of the apparatus by employing a suitable
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`thermometerand a controller.
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`Fig. 13 shows, similar to Figs 1-4, an embodimentof an apparatus 1’ thatis
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`particularly suitable for skin tissue areas 3 that are not easily folded by pinching as explained
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`supra, comprising a mechanical deformer 25 in the form of a mask comprising a pattern of
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`30
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`electrically insulating protrusions 27 correspondingto the plurality of folds 17 to be formed
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`into the skin tissue area 3,
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`Top viewsof typical patterns of electrodes 13 and protrusions 27 for forming a
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`one-dimensionalarray of depressions and folds into the skin tissue area 3 to be treated are
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`10
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`shown in Figs. 14A-14D, and Figs 14E-14F similarly show exemplary patterns of protrusions
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`27 configured to deform the skin tissue area 3 into a deformed shape comprising a
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`two-dimensional array of skin tissue folds 17. The deformercan have pins or edges of any
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`type and/or configuration, e.g. as indicated in Fig. 14A, pins 27 placed in line with RF
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`TS
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`electrodes 13 and/or elongated edges placed in line with electrodes 13 as in Figs 14B-14C.
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`The electrodes 13 can have different geometries and can even have a high aspect ratio to
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`cover a significant area of skin. Other patterns, possibly irregularly shaped and/or producing
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`non-equidistant or unevenly deep skin tissue folds, are equally conceivable.
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`Figs. 15A-15B show, similar to Figs. 1-4 and 13, a further embodimentof an
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`10
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`apparatus 1” comprising a mechanical deformer 29 comprising a plurality of electrically
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`insulating protrusions 27 connected with a vacuum system 31 capable of providing a sub-
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`atmospheric pressure between at least some of the protrusions 27. When the deformer29 is
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`placed in contact with the skin surface 3 and the vacuum system is activated, the skin 3 can
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`be suckedinto the areas 33 of negative pressure between the protrusions 27 and conform to
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`15
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`the edges 27 forming the desired folds 17 (Fig. 15B). The vacuum pressure may be controlled
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`by employing a suitable profilometer and a controller.
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`In a preferred embodiment, the insulating deformer portions 27 and RF
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`electrodes 13 are integrated into a single series of objects, forming folds 17 by domingof the
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`skin 3 between the objects when they are pressed against the skin surface 5. Such an
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`20
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`arrangement is shown in the embodimentof Fig. 16A, the use of which is shownin Fig. 16B
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`in similar fashion as in Figs. 1-4, 13 and 15A-15B. The shown embodiment, resembling a
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`knownshaving device, enables the production of a radial pattern of skin folds 17 and
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`associated heated skin tissue zones 19.
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`In particular for flexible skin portions, e.g. facial skin, deforming features 27
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`of a skin deformer may be closely spaced in the millimeter or even sub-millimeter range, and
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`fold amplitudes in the range of about 100-300 micrometer, e.g. in a range of about 150-250
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`micrometer, may suffice for suitable heating of the dermal-epidermal junction which may be
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`located at a depth of about 100-200 micrometer from the skin surface. Little separation
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`between the RF electrodes 13 may reduce the RF powerrequired for suitable skin tissue
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`30
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`heating.
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`‘The presently provided apparatus allowstreating much smaller zones oftissue
`layers than known devices, whichserve to treat skin tissue areas of 1-50 cm’, typically
`regions of about 10 cm”. However,the use of the present apparatus and methodis not
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`dictated by inter-electrode distances and much smaller treatment areas and/or details are
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`WO 2014/009875
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`11
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`possible. For example, folded tissue areas with an interdistance of 0.1-2 cm (with respect to a
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`direction generally perpendicular to the folds) and electrode sizes of 0.1-1 cm are possible,
`resulting in heated tissue zones with typical sizes and/ordetails of the order of 0).01-2 cm*.
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`Also, in apparatus using vacuum pressure a relatively small under-pressure maysuffice, e.g.
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`it
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`0.01-0.05 atmosphere (negative pressure) with respect to ambient pressure. Other variations
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`to the disclosed embodiments can be understood and effected by those skilled in the art in
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`practicing the claimed invention, from a study of the drawings, the disclosure, and the
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`appended claims. For instance, any template capable of forming at least two skin protrusions
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`can be used with both positive and negative pressure vacuum configurations. The fold depth
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`10
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`and interfold distance can be varied to influence the treatment.
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`The deformer or the vacuum surface can be used to conductively cool the skin
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`to enhance the RF heating in deepertissue layers.
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`An additional feature of the skin manipulation can be a profilometer, e.g. a
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`contact sensor and/or an optical sensor that facilitate determination of whether the amplitude
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`15
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`of at least a portion of the skin tissue folds, e.g. particular skin tissue protrusions between
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`deformerstructures, are sufficient to trigger application of RF current.
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`Any type of RF power settings can be used. In one embodiment, a frequency
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`of 1MHz and a power of 25W isapplied to the skin for a sustained period in the range of 1
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`msec — 5 sec.
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`20
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`In any one of the embodiments of an apparatus 1, 1’, 1” according to the
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`invention described before, the apparatus may comprise a control unit configured and
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`arranged to operate the apparatus so as to form the skin tissue area into the desired deformed
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`shape comprising a plurality of folds in th