( 19 ) United States
`( 12 ) Patent Application Publication ( 10 ) Pub . No .: US 2020/0155221 A1
`( 43 ) Pub . Date :
`May 21 , 2020
`Marchitto et al .
`
`US 20200155221A1
`
`IN
`
`( 71 )
`
`( 54 ) INDUCTIVE HEATING OF TISSUES USING
`ALTERNATING MAGNETIC FIELDS AND
`USES THEREOF
`Applicant : ROCKY MOUNTAIN
`BIOSYSTEMS , INC . , WHEAT
`RIDGE , CO ( US )
`( 72 ) Inventors : Kevin S. Marchitto , Golden , CO ( US ) ;
`Stephen T. Flock , Arvada , CO ( US )
`( 21 ) Appl . No .: 16 / 600,677
`( 22 ) Filed :
`Oct. 14 , 2019
`Related U.S. Application Data
`( 63 ) Continuation of application No. 12 / 927,746 , filed on
`Nov. 23 , 2010 , now Pat . No. 10,441,346 , which is a
`continuation - in - part of application No. 12 / 080,897 ,
`filed on Apr. 7 , 2008 , now Pat . No. 10,271,900 .
`( 60 ) Provisional application No. 60 / 922,249 , filed on Apr.
`6 , 2007 .
`
`Publication Classification
`
`( 51 ) Int . Ci .
`A61B 18/14
`A61N 2/00
`A61N 2/02
`
`( 2006.01 )
`( 2006.01 )
`( 2006.01 )
`
`2210
`
`2450
`
`2330
`
`2320
`
`2310
`
`( 52 ) U.S. CI .
`A61B 18/14 ( 2013.01 ) ; A61N 2/002
`CPC
`( 2013.01 ) ; A61B 2018/00452 ( 2013.01 ) ; A61N
`2/02 ( 2013.01 ) ; A61N 2/004 ( 2013.01 )
`
`( 57 )
`
`ABSTRACT
`
`Provided herein are methods and devices for inductively
`heating a tissue to effect a biological response in the tissue
`or in a biomolecule comprising the same . The methods and
`devices comprise means for applying a high frequency
`alternating magnetic field via an inductive coil comprising
`an applicator to the tissue and means for monitoring feed
`back from the alternating magnetic field to control and / or
`adjust heat , for example , in the tissue , which further includes
`a means for cooling the tissue . Particularly , the device may
`be a hand held piece that incorporates or has at least an
`applicator , including a radiofrequency energy generator and
`output , an inductive coil , an impedance matching system , a
`cooling system , including a thermally conductive surface
`and a coolant housing containing a coolant that circulates
`through the thermally conductive surface , and a feedback
`monitor . Optionally , the device may comprise a tissue
`shaper .
`
`-2220
`
`2230
`
`2240
`
`2250
`
`2260
`
`2270
`
`2280
`
`LUMENIS EX1066
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`

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`Patent Application Publication May 21 , 2020 Sheet 1 of 10
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`US 2020/0155221 A1
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`2210
`
`2450
`
`2330
`
`2320
`
`2310
`
`2220
`
`2230
`
`2240
`
`2250
`
`-2260
`
`2270
`
`2280
`
`FIG . 1
`
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`Patent Application Publication May 21 , 2020 Sheet 2 of 10
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`US 2020/0155221 A1
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`3520
`
`3560
`
`3350
`
`3600
`
`3500
`
`3300
`
`4300
`
`FIG . 2A
`
`FIG . 2B
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`

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`Patent Application Publication May 21 , 2020 Sheet 3 of 10
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`US 2020/0155221 A1
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`3500
`
`2450
`
`000 0000
`
`3350
`
`3450
`
`2280
`
`3550
`
`FIG . 3
`
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`Patent Application Publication May 21 , 2020 Sheet 4 of 10
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`US 2020/0155221 A1
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`3500
`
`4260
`
`0
`
`4150
`
`4300
`
`FIG . 4
`
`LUMENIS EX1066
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`Patent Application Publication
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`May 21 , 2020 Sheet 5 of 10
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`US 2020/0155221 A1
`
`Applicator
`
`
`
`Small capacitor C = 6.8 PF
`
`Pancake Coil L = 200 nH
`
`
`
`Large capacitor c = 69.7 PF
`
`+
`
`Radiofrequency Generator Z = 50 ohms
`
`FIG . 5
`
`LUMENIS EX1066
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`Patent Application Publication May 21 , 2020 Sheet 6 of 10
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`US 2020/0155221 A1
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`muscle
`
`blood
`
`40
`
`30
`
`20 Time ( seconds )
`
`10
`
`FIG . 6
`
`0
`
`10 o
`
`C )
`( degrees
`
`Temperature
`
`LUMENIS EX1066
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`

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`Patent Application Publication
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`May 21 , 2020 Sheet 7 of 10
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`US 2020/0155221 A1
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`fat muscle
`
`skin
`
`25
`
`20
`
`15 Time ( seconds )
`
`FIG . 7
`
`10
`
`5
`
`o
`
`09
`
`40
`
`20
`
`C )
`( degrees
`
`Temperature
`
`LUMENIS EX1066
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`Patent Application Publication May 21 , 2020 Sheet 8 of 10
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`US 2020/0155221 A1
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`Untreated
`
`Treated + 2 weeks
`
`Treated + 2 weeks
`
`FIG . 8A
`
`FIG . 8B
`
`FIG . 8C
`
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`Patent Application Publication May 21 , 2020 Sheet 9 of 10
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`US 2020/0155221 A1
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`Untreated control
`
`Treated
`
`FIG . 9A
`
`FIG . 9B
`
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`Patent Application Publication May 21 , 2020 Sheet 10 of 10
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`US 2020/0155221 A1
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`elastic fiber
`
`het en
`ovell
`GO
`
`Stretch
`
`Relax
`
`single elastin molecule
`cross - link
`
`Tighten
`
`Je
`T Wood
`
`FIG . 10
`
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`US 2020/0155221 A1
`
`1
`
`May 21 , 2020
`
`INDUCTIVE HEATING OF TISSUES USING
`ALTERNATING MAGNETIC FIELDS AND
`USES THEREOF
`
`CROSS - REFERENCE TO RELATED
`APPLICATIONS
`This application is a continuation of U.S. patent
`[ 0001 ]
`application Ser . No. 12 / 927,746 filed Nov. 23 , 2010 , which
`is a continuation - in - part of U.S. patent application Ser . No.
`12 / 080,897 filed Apr. 7 , 2008 , now U.S. Pat . No. 10,271 ,
`900 , which issued on Apr. 30 , 2019 , which claims the benefit
`of U.S. Provisional Application No. 60 / 922,249 , filed Apr. 6 ,
`2007 , now abandoned , the entirety of which are hereby
`incorporated by reference .
`BACKGROUND OF THE INVENTION
`
`Field of the Invention
`[ 0002 ] The present invention relates generally to the fields
`of biomedical engineering , biochemistry , medical treatment ,
`and surgical procedures . More specifically , the present
`invention provides methods , devices , and compositions for
`inducing changes in tissues , biomolecules , including bioac
`tive molecules . These changes are notably useful for induc
`ing alterations in tissues , most notably in skin , for cosmetic
`purposes .
`
`Description of the Related Art
`[ 0003 ] Heating of tissue is a fundamental physical event in
`many different medical procedures . Depending on the time
`temperature history of the tissue , a cascade of physical ,
`chemical , and biological events occurs when tissue is
`heated . These events can lead to a beneficial or deleterious
`response . One example of a beneficial response is the
`reduction or elimination of the appearance of skin wrinkles
`as a result of heat induced tissue contraction and skin
`thickening as a result of neocollagen formation following
`heat stimulation in tissues .
`[ 0004 ]
`Skin wrinkles are often the consequence of advanc
`ing age and sun exposure . With increasing age and excessive
`sun exposure , skin quality deteriorates . This is due , in part ,
`to changes in hydration and epidermal thickness , and on a
`molecular scale , to a decrease in the amount of collagen in
`the dermis . Further , subcutaneous fat accumulates or atro
`phies leading to furrowing of the skin , which produces
`wrinkles . In today's society , the appearance of skin wrinkles
`is often viewed negatively and so there is a desire in the
`community for a means to safely reduce or eliminate
`wrinkles .
`[ 0005 ] For many years , wrinkles have been treated with
`chemical peels or mechanical dermabrasion , cosmetic medi
`cal procedures in which the surface of the epidermis of the
`skin , i.e. , the stratum corneum , is removed chemically or by
`abrasion , such as sanding , respectively . In the late 1980s ,
`laser ablation procedures for skin resurfacing were devel
`oped and approved .
`[ 0006 ] Some of the first laser ablation procedures involved
`CO2 lasers , which ablated some or all of the outermost layer
`of the epidermis , the stratum corneum . The CO2 lasers could
`often generate enough heat in the dermis to cause a tissue
`contraction . This and subsequent repair of the epidermis and
`stratum corneum led to visible effects including wrinkle
`reduction and smoothing of the skin .
`
`[ 0007 ] Nonetheless , inadvertent and lasting damage from
`burns to the epidermis was often evident , hypo- or hyper
`pigmentation was fairly common , and patients receiving
`these treatments were required to stay indoors for weeks in
`order to avoid damaging ultraviolet rays from sunlight in
`their now unprotected dermal layers of skin . These lasers
`gave way to various lasers that operated at different wave
`lengths with the goal of reducing the negative effects . Today ,
`laser procedures that are non - ablative and less damaging to
`surrounding tissues have replaced most of these original
`laser procedures . These lasers are much safer and produce
`much less damage to surrounding tissues , however much of
`the beneficial effects have also been lost , particularly with
`regard to skin tightening .
`[ 0008 ]
`In the mid to late 1990s , another cosmetic tech
`nique for skin was developed that involves a non - ablative
`thermal alteration to skin . This procedure was based on
`concepts drawn from radiofrequency electrosurgical devices
`where electrical current is introduced into the patient via an
`electrode in electrical contact with tissue and exits through
`a ground electrode in contact elsewhere on the patient . These
`devices are referred as capacitive coupled devices whereby
`current flows between electrodes , and on the way , fields
`build up where tissues of relatively greater resistance are
`encountered .
`[ 0009 ]
`In the case of skin , the stratum corneum and
`epidermis are only weakly conductive , so fields and heat
`build up there . Current flows through the conductive dermis ,
`and again encounters resistance at the adiposal level , again
`resulting in heat generation . In skin , the treatment technique
`is referred to as radiofrequency ( RF ) skin rejuvenation ( 1 ) .
`[ 0010 ]
`In the skin , beneficial radiofrequency rejuvenation
`can result in tissue contraction as heat flows from the areas
`of field concentration , such as the adipose layer and epider
`mis , and into the dermis . Furthermore , a beneficial wound
`response to the heat in the dermis can lead to production of
`new collagen , and ultimately the skin may thicken . When
`treating the skin with RF devices , it is necessary to provide
`a conductive coupling gel between the skin and electrodes to
`allow for current flow .
`[ 0011 ] Capacitive - coupled devices may result in negative ,
`and sometimes severe consequences with regard to damage
`to tissues where the electric fields concentrate . Current
`generally follows the path of least resistance and thus it is
`not always predictable or controllable where its effects will
`occur . Any current that flows through the body is potentially
`hazardous . As the electric fields concentrate at non - conduc
`tive interfaces , electrical burns and heat damage may
`become evident at these interfaces . Burns are common at the
`electrodes in electrosurgical devices , and similarly , RF reju
`venation devices may also produce burns . In skin , capaci
`tively - coupled radiofrequency heating exhibits preferential
`power absorption in the epidermis and in lower - conductivity
`subcutaneous fat . In
`other words , capacitive - coupled
`devices preferentially heat tissues with higher specific resis
`tance ( 2-3 ) . As a result , these tissues are at risk for damage .
`[ 0012 ]
`To counter the effects of deleterious heating at the
`skin surface , capacitive - coupled skin rejuvenation devices
`( 4 ) , and lasers ( 5-6 ) , often use some mechanism to cool the
`surface of the skin , thereby avoiding most of the damage to
`the outer epidermis and stratum corneum . Nonetheless , the
`risk of heating adipose tissue below the dermis is everpre
`sent with RF devices and , anecdotally , patients have com
`plained of long - term subcutaneous fat atrophy following
`
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`
`2
`
`May 21 , 2020
`
`treatment with these devices , with some of these requiring
`grafting . Efforts to reduce such detrimental effects require
`reduction of power output and have likely reduced efficacy
`of these devices .
`[ 0013 ] More recently , additional devices for skin rejuve
`nation have been developed that employ ultrasound In an
`attempt to provide specific and localized treatment to the
`dermis . The devices focus the ultrasound within the dermis ,
`or just below to achieve specific heating . Though specificity
`is improved , cavitation can result in pain and tissue damage .
`Burning and necrosis of the epidermis and stratum corneum
`during laser and RF cosmetic skin treatments is of major
`concern . Thus , various methods of skin cooling are often
`employed , including the spraying of cryogen on the skin
`surface or on an applicator , or applying cold air , water or ice
`to the skin .
`[ 0014 ]
`In contrast to the aforementioned tissue heating
`devices and technology , magnetic induction applicators ,
`such as those used in magnetic induction diathermy devices
`primarily induce ( eddy ) currents to flow along pathways
`governed by electric conductivities , hence depositing more
`power in tissues of higher conductivity ( 2 ) . Inductively
`coupled diathermy units use induced eddy currents to heat
`tissue , especially tissue , such as muscle , with high water
`content ( 7 ) , but only weakly affect tissues with high fat
`content ( 8 ) . Nonetheless , diathermy devices are used for
`deep heating of tissue structures , and their effects on thin
`tissue layers such as the dermis have yet to be described .
`[ 0015 ]
`Thus , there is a recognized , continuing need for
`improved methods and devices for specific heating of the
`thin dermal layer of skin with a high degree of specificity ,
`efficacy and safety . Moreover , there is a recognized need for
`improvements in the use of magnetic induction methods and
`devices to heat tissue near or at the skin surface , and
`particularly , for specific dermal heating to achieve a cos
`metic result .
`[ 0016 ] The prior art is deficient in methods and devices for
`highly efficient and safe non - invasive heating of the skin ,
`with high specificity for the dermis , while protecting col
`lateral tissue structures . The present invention fulfills this
`longstanding need and desire in the art .
`SUMMARY OF THE INVENTION
`[ 0017 ] The present invention is directed to a method for
`inducing heat in the dermis of a subject to effect a biological
`response . The method comprises the step of applying a high
`frequency alternating magnetic field to the skin of the
`individual such that the magnetic field inductively heats the
`dermis , thereby effecting the biological response therein . In
`a related method an area of skin is mechanically or pneu
`matically shaped prior to applying the high frequency alter
`nating magnetic field thereto . In another related method , one
`of radiant energy , acoustic energy or vibrational energy is
`applied to the skin concurrently or sequentially with the high
`frequency alternating magnetic field . In yet another related
`method , feedback from the magnetic field is monitored and
`an amount of heat induced in the dermis in the individual is
`adjusted based on the feedback . In yet another related
`method , the dermis of the subject is cooled to disperse heat
`generated therein .
`[ 0018 ] The present invention also is directed to a device
`for heating a tissue in a subject . The device comprises a
`means for generating a high frequency alternating magnetic
`field to alter one or both of a tissue or a biomolecule
`
`comprising the same in the subject and a means for con
`trolling the alteration of the tissue or biomolecule . A related
`device further incorporates a means for housing the device .
`Another related device further incorporates a means for
`monitoring feedback from one or more of another source of
`radiant energy , plasma energy , acoustic energy , or bipolar or
`monopolar electrosurgical energy .
`[ 0019 ] The present invention is directed further to another
`device for heating tissue in a subject . The device comprises
`a hand held piece that incorporates or has an applicator with
`a radiofrequency energy generator and an energy output , an
`impedance matching network in electrical contact with the
`applicator , an inductive coil connected to the energy output ,
`an end plate at a distal end of the hand held piece that has
`a thermally conductive surface positionable on the tissue
`and , optionally , is in thermal contact with the inductive coil .
`A related device further comprises a coolant housing con
`taining a coolant and in fluid contact with the inductive coil
`and , optionally , the thermally conductive surface . Another
`related device further comprises a mechanical tissue - shaper
`or a pneumatic tissue - shaper in contact with the tissue .
`Another related device further comprises a heat feedback
`monitor positioned distal to the induction coil or proximate
`to the tissue .
`[ 0020 ] Other and further aspects , features , and advantages
`of the present invention will be apparent from the following
`description of the presently preferred embodiments of the
`invention given for the purpose of disclosure .
`BRIEF DESCRIPTION OF THE DRAWINGS
`[ 0021 ] So that the matter in which the above - recited
`features , advantages and objects of the invention , as well as
`others that will become clear , are attained and can be
`understood in detail , more particular descriptions of the
`invention briefly summarized above may be had by refer
`ence to certain embodiments thereof that are illustrated in
`the appended drawings . These drawings form a part of the
`specification . It is to be noted , however , that the appended
`drawings illustrate preferred embodiments of the invention
`and therefore are not to be considered limiting in their scope .
`[ 0022 ] FIG . 1 depicts an applicator that transduces radiof
`requency electrical energy into a magnetic field .
`[ 0023 ] FIGS . 2A - 2B depict a front view ( FIG . 2A ) and a
`side view ( FIG . 2B ) of a hand piece incorporating a mag
`netic field applicator with optional cooling system .
`[ 0024 ] FIG . 3 depicts the endplate of the hand piece .
`[ 0025 ] FIG . 4 depicts a hand piece incorporating a sole
`noid - type inductor and positioning of tissue using pneumatic
`pressure .
`[ 0026 ]
`FIG . 5 depicts a circuit diagram of the applicator .
`[ 0027 ] FIG . 6 shows measurements taken at 27 MHz and
`600 W. Bovine muscle , bovine fat , ovine skin , and human
`blood were used for comparison . The tissues were cut to
`2x2x5 cm samples . Each sample was placed directly on the
`cap of the 27 MHz device and imaged from above with a
`Raytek IR thermometer . The device was activated and the
`time to heat was recorded . ( n = 3 for each tissue type ) .
`[ 0028 ] FIG . 7 shows porcine fat , muscle and skin were
`used for comparison . The tissue samples were measured for
`thickness to ensure consistency between samples . The
`samples were between 1.5-2.0 mm in thickness . The samples
`were placed on the faceplate which is 4 mm thick PVC and
`imaged from above with a Raytek IR thermometer . The
`device was turned on and the time for the sample to reach
`
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`
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`
`70 ° C. was recorded . The IR thermometer is limited to
`recording the tissue surface opposite that which is in contact
`with the device . Therefore , it is believe that the actual
`temperature of the tissue was greater than indicated on the
`graph .
`[ 0029 ] FIGS . 8A - 8C show biopsied samples at the two
`week post - treatment time point ( FIGS . 8B - 8C ) demonstrat
`ing a thickening of the dermis as compared to untreated
`controls ( FIG . 8A ) .
`[ 0030 ] FIGS . 9A - 9B show biopsied samples before and
`after treatment demonstrating a production of neo - collagen
`in treated tissues ( FIG . 9B ) as compared to the untreated
`controls ( FIG . 9A ) .
`[ 0031 ]
`FIG . 10 shows a model of the expected mode of
`action produced by inductive heating on collagen within the
`treated tissues .
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`[ 0032 ] As used herein , the term , “ a ” or “ an ” may mean one
`or more . As used herein in the claim ( s ) , when used in
`conjunction with the word " comprising " , the words " a " or
`" an " may mean one or more than one . As used herein
`" another ” or “ other ” may mean at least a second or more of
`the same or different claim element or components thereof .
`[ 0033 ] As used herein , the term “ or ” in the claims refers
`to “ and / or ” unless explicitly indicated to refer to alternatives
`only or the alternatives are mutually exclusive , although the
`disclosure supports a definition that refers to only alterna
`tives and " and / or ” .
`[ 0034 ] As used herein , the term “ subject ” refers to any
`recipient of at least high frequency alternating magnetic field
`as a means for inductively heating a tissue , for example , the
`skin or dermis , thereof to cause or to effect a biological
`response in the tissue or its components or biomolecules
`comprising the same .
`[ 0035 ]
`In one embodiment of the present invention there is
`provided a method for inducing heat in the dermis of a
`subject to effect a biological response , comprising the step
`of applying a high frequency alternating magnetic field to
`the skin of the individual , whereby the magnetic field
`inductively heats the dermis , thereby effecting the biological
`response therein .
`[ 0036 ] Further to this embodiment the method may com
`prise mechanically or pneumatically shaping an area of skin
`prior to applying the high frequency alternating magnetic
`field thereto . In another further embodiment the method may
`comprise applying radiant energy , acoustic energy or vibra
`tional energy to the skin concurrently or sequentially with
`the high frequency alternating magnetic field .
`[ 0037 ]
`In another further embodiment the method may
`comprise monitoring feedback from the magnetic field and
`adjusting an amount of the heat induced in the dermis in the
`individual based on the feedback . In this further embodi
`ment the step of feedback monitoring may comprise one or
`more of detecting heat in the dermis , detecting eddy currents
`formed in the dermis , detecting hydration changes in the
`dermis , or detecting impedance changes in the dermis . In
`representative examples detecting heat in the dermis may
`comprise monitoring heat sensitive liquid crystal media or
`monitoring infrared radiation . Further to this embodiment
`feedback monitoring further may comprise monitoring heat
`generated by one or more of another source of radiant
`
`energy , plasma energy , acoustic energy , or bipolar or
`monopolar electrosurgical energy .
`[ 0038 ]
`In yet another further embodiment the method may
`comprise cooling the dermis of the subject to disperse heat
`generated therein . In this further embodiment the step of
`cooling the dermis may comprise positioning a thermally
`conductive surface in contact with one or both of the skin or
`an exterior surface of an inductive coil generating the
`alternating magnetic field . A thermally conductive surface
`may be a heat sink that passiviely disperses heat , may have
`a coolant circulating therethrough , may be a cryogenic
`material or may have a cryogenic material disposed thereon .
`[ 0039 ] In all embodiments the biological response may be
`one or more of tissue coagulation , cauterization , tissue
`contraction , tissue shrinkage , induction of wound response ,
`production of collagen . Also , the inductive heating may
`activate collagen repair and tissue growth or improves skin
`cosmesis by smoothing the skin or reducing skin laxity .
`[ 0040 ]
`In another embodiment of the present invention
`there is provided a device heating a tissue in a subject ,
`comprising means for generating a high frequency alternat
`ing magnetic field to alter one or both of a tissue or a
`biomolecule comprising the same in the subject ; and means
`for controlling the alteration of the tissue or biomolecule .
`[ 0041 ] In this embodiment the means for providing the
`high frequency alternating magnetic field may be an appli
`cator having an induction coil and an output for radiofre
`quency energy . Also in this embodiment the means for
`controlling the alteration of the tissue or biomolecule may
`comprise a monitoring system for feedback from the high
`frequency alternating magnetic field distal to the induction
`coil or proximate to the tissue .
`[ 0042 ] Further to these embodiments the device may com
`prise means for housing the device . In this further embodi
`ment the means for housing the device may be a hand held
`piece having an impedance matching network and a coupler
`to couple to an output of a radiofrequency energy source .
`Also , in this further embodiment the hand held piece further
`may comprise an end plate at a distal end thereof and having
`a thermally conductive surface positionable to contact one or
`both of the tissue or the exterior of the applicator . Examples
`of a thermally conductive surface are a passive heat sink , a
`cryogenic material or the thermally conductive surface has
`a cryogenic material applied thereto . In addition , the hand
`held piece further may comprise a coolant housing attached
`thereto and containing coolant which is in fluid contact with
`one or both of the thermally conductive surface on the end
`plate and an inductive coil comprising an applicator where
`the coolant circulates therethrough . Furthermore , the hand
`held piece further may comprise a mechanical tissue - shaper
`or a pneumatic tissue - shaper in contact with the tissue .
`[ 0043 ]
`In another further embodiment the device may
`comprise means for monitoring feedback from one or more
`of another source of radiant energy , plasma energy , acoustic
`energy , or bipolar or monopolar electrosurgical energy . In all
`embodiments the tissue may be skin .
`[ 0044 ]
`In yet another embodiment of the present invention
`there is provided a device for heating a tissue in a subject ,
`comprising a hand held piece incorporating an applicator
`with a radiofrequency energy generator and an energy
`output ; an impedance matching network in electrical contact
`with the applicator ; an inductive coil connected to the energy
`output ; and an end plate at a distal end of the hand held piece
`
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`4
`
`May 21 , 2020
`
`that has a thermally conductive surface positionable on the
`tissue and , optionally , is in thermal contact with the induc
`tive coil .
`[ 0045 ]
`In a further embodiment the device may comprise
`a coolant housing containing a coolant and in fluid contact
`with the inductive coil and , optionally , the thermally con
`ductive surface In another further embodiment the device
`may comprise a mechanical tissue - shaper or a pneumatic
`tissue - shaper in contact with the tissue . In yet another further
`embodiment the device may comprise a heat feedback
`monitor positioned distal to the induction coil or proximate
`to the tissue . In all embodiments the tissue may be as
`described supra .
`[ 0046 ]
`The present invention provides methods and
`devices for treatment of tissues in a subject , preferably for
`cosmetic treatment of skin , with a high degree of specificity
`for the dermis . The devices are magnetic induction devices
`of such geometry that they provide a concentrated and
`intense alternating magnetic field to shallow layers of skin ,
`when placed in close proximity to the skin . The method
`involves creating a high - frequency alternating magnetic
`field that , when directed in proximity with tissue , results in
`the production of heat through inductive coupling with the
`tissue thus resulting in the desired biologic effect . Repre
`sentative examples of such biologic effects include , but are
`not limited to coagulation , cauterization , tissue contraction
`or shrinkage , and induction of a wound response that leads
`to biomolecular changes . Generally , application of the high
`frequency alternating magnetic field itself may induce , or
`the concomitant production of heat may induce , the move
`ment of a charged species or other biomolecule or bioactive
`molecule or species within the tissue leading to various
`biological responses , such as , but not limited to , the pro
`duction of collagen by cells and dermal thickening .
`[ 0047 ] Particularly , utilizing the present methods and
`devices improves the cosmetic appearance of the skin by
`controllably heating a superficial layer of skin , preferably ,
`the dermis . An acute tissue contraction or shrinkage and / or
`a wound response is effected which leads to the production
`of biomolecules resulting in improved cosmesis . Preferably ,
`the devices are used for the direct heating of moist conduc
`tive tissues , such as the viable dermis , during cosmetic skin
`treatment , and less efficiently for tissues of low conductivity
`which may in part be due to low hydration ( e.g. stratum
`corneum ) or of low polarity ( adipose ) , thereby providing a
`safer means for treating skin . The device and its method of
`use minimizes the risk of significant burns to the skin
`surface , and eliminates charring and the generation of
`smoke , as it does not rely on capacitive coupling for its
`effects . The patient is isolated from the electrical current in
`the devices and no electrical current is conducted from the
`applicator or the patient .
`[ 0048 ] Generally , the devices provided herein comprise a
`means for generating and applying a high frequency alter
`nating magnetic field , a means for controlling the alteration
`of the tissue or biomolecule contained therein , a means for
`monitoring feedback related to heat generation , and a means
`for housing the device . Particularly , the devices may be hand
`held such that a hand held piece incorporates a source of
`radiofrequency electrical energy coupled to a coil and an
`impedance matching network to produce an alternating
`magnetic field . When tissue is brought into proximity of the
`alternating magnetic field , heating of the tissue results as a
`
`consequence of either or both of dipole formation and
`oscillation or eddy current formation .
`[ 0049 ] Optionally , cooling is provided to remove or dis
`perse heat from the coil , the source of RF electrical energy ,
`or the surface of the skin alone or in combination . For
`example , a disposable or permanent tip , or cover placed
`between the induction coil and the skin provides a thermally
`conductive surface that absorbs and distributes heat arising
`from the skin surface , for example , as a heat sink . Alterna
`tively , a thermally conductive substance may be placed on
`the skin or tissue . Also , feedback monitoring of heat gen
`eration , eddy current formation in the tissue , ultrasound
`detection of tissue alterations , changes in impedence in
`tissues that lead to an impedance mismatch between the
`magnetic field applicator and the radiofrequency generator ,
`hydration , etc. provides for the adjustable control of induc
`tively generated heat in the tissue and / or device
`[ 0050 ] The methods and devices provided herein exhibit
`the significant benefits of , among other things , being non
`invasive , not requiring electrical contact with the body of the
`subject , and providing controllable heating only to a thin
`layer of tissue . The invention is useful not only for cosmetic
`procedures such as facial rejuvenation , wrinkle treatment ,
`acne treatment , hair removal , vascular lesion treatment ,
`varicose vein treatment , curing of fillers , and treatment of
`cellulite , but also for surgical procedures such as coagula
`tion , cauterization or for induction of biomolecular events ,
`such as , but not limited to , a wound response , production of
`heat - shock proteins or an inflammatory response in tissue .
`[ 0051 ] As described below , the invention provides a num
`ber of therapeutic advantages and uses , but such advantages
`and uses are not limited by such description . Embodiments
`of the present invention are better illustrated with reference
`to the Figures , however , such reference is not meant to limit
`the present invention in any fashion . The embodiments and
`variations described in detail herein are to be interpreted by
`the appended claims and equivalents thereof .
`Radiofrequency Power Supply
`[ 0052 ] The invention consists of a source of radiofre
`quency ( RF ) electrical energy , which may be supplied using
`a RF generator such as sold by Comdel , Inc. ( e.g. CV1000
`or CV500 , preferably 40.68 MHz or 27.1 MHz , Gloucester ,
`Mass . ) . The electrical output of the generator is coupled to
`an applicator consisting of an inductor in the form of a coil
`( for the generation of a magnetic field ) , which is further part
`of an impedance matching network that may additionally
`comprise a capacitor . The source of energy used may be a
`constant current or a constant voltage power supply or may
`be a modulated current or a modulated voltage power
`supply .
`[ 0053 ] The power - supply is able to produce radiofre
`quency energy with a power in the range 10-10,000 W and ,
`depending on the application , preferably in the range of
`about 100 to about 1000 W. The power