`Marchitto et al .
`
`( 10 ) Patent No . : US 10 , 271 , 900 B2
`( 45 ) Date of Patent :
`Apr . 30 , 2019
`
`US010271900B2
`
`( * ) Notice :
`
`( 54 ) INDUCTIVE HEATING OF TISSUES USING
`ALTERNATING MAGNETIC FIELDS AND
`USES THEREOF
`( 75 ) Inventors : Kevin S . Marchitto , Golden , CO ( US ) ;
`Stephen T . Flock , Arvada , CO ( US )
`( 73 ) Assignee : ROCKY MOUNTAIN
`BIOSYSTEMS , INC , Wheat Ridge ,
`CO ( US )
`Subject to any disclaimer , the term of this
`patent is extended or adjusted under 35
`U . S . C . 154 ( b ) by 175 days .
`( 21 ) Appl . No . : 12 / 080 , 897
`( 22 ) Filed :
`Apr . 7 , 2008
`( 65 )
`Prior Publication Data
`US 2008 / 0249350 A1
`Oct . 9 , 2008
`Related U . S . Application Data
`( 60 ) Provisional application No . 60 / 922 , 249 , filed on Apr .
`6 , 2007 .
`Int . CI .
`A61B 18 / 18
`A61B 18 / 14
`
`( 51 )
`
`( 52 ) U . S . CI .
`CPC
`
`( 58 )
`
`( 2006 . 01 )
`( 2006 . 01 )
`( Continued )
`A61B 18 / 18 ( 2013 . 01 ) ; A61B 18 / 14
`( 2013 . 01 ) ; A61N 2 / 002 ( 2013 . 01 ) ; A61N
`2 / 004 ( 2013 . 01 ) ;
`( Continued )
`Field of Classification Search
`CPC . . . . . . . . . . A61B 18 / 14 ; A61B 2018 / 00452 ; A61B
`2018 / 0047
`( Continued )
`
`( 56 )
`
`References Cited
`U . S . PATENT DOCUMENTS
`4 , 889 , 120 A
`12 / 1989 Gordon
`5 , 057 , 106 A
`10 / 1991 Kasevich et al .
`( Continued )
`OTHER PUBLICATIONS
`“ Electromagnetic radiation . ” Collins Dictionary of Astronomy . Lon
`don : Collins , 2006 . Credo Reference . Web . May 24 , 2012 . *
`( Continued )
`Primary Examiner - Michael F Peffley
`Assistant Examiner — Samantha M Good
`( 74 ) Attorney , Agent , or Firm — Merchant & Gould P . C .
`( 57 )
`ABSTRACT
`The present invention improves the cosmetic appearance of
`skin by controllably heating a superficial layer of skin
`thereby inducing acute tissue contraction or shrinkage and a
`wound response leading to the production of biomolecules ,
`all of which result in improved cosmesis . The invention
`incorporates a source of radiofrequency electrical energy
`coupled to coil , with requisite impedance matching network ,
`thereby resulting in the production of an alternating mag
`netic field . When tissue is brought into proximity of the
`alternating magnetic field , inductive heating of the tissue
`results as a consequence of either or both of dipole formation
`and oscillation , and eddy current formation . Optionally ,
`cooling is provided to remove heat from the coil , the source
`of radiofrequency electrical energy , or the surface of the skin
`alone or in combination . The invention exhibits the signifi
`cant 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 .
`16 Claims , 10 Drawing Sheets
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`US 10 , 271 , 900 B2
`Page 2
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`( 51 )
`
`( 2006 . 01 )
`( 2006 . 01 )
`( 2006 . 01 )
`
`Int . CI .
`A6IN 2 / 00
`A61N 2 / 02
`A61B 18 / 00
`( 52 ) U . S . CI .
`CPC . . . . . . . . A61N 2 / 02 ( 2013 . 01 ) ; A61B 2018 / 0047
`( 2013 . 01 ) ; A61B 2018 / 00452 ( 2013 . 01 )
`( 58 ) Field of Classification Search
`. . . . . . . . . . . 606 / 32 – 33 ; 607 / 100 - 102
`USPC . . . . . . . . . . .
`See application file for complete search history .
`
`( 56 )
`
`219 / 635
`
`. 606 / 27
`
`References Cited
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`3 / 2007 Knowlton
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`7 , 967 , 839 B26 / 2011 Flock et al .
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`2 / 2003 Altshuler et al . . . . . . . . . . . . . . . . . . 606 / 9
`2004 / 0122494 A1 *
`6 / 2004 Eggers et al . . . . . . . . . . . . . . . . 607 / 103
`
`2004 / 0127895 A1 *
`2004 / 02 10214 A1 *
`2011 / 0077451 AL
`
`7 / 2004 Flock et al . . . . . . . . . . . . . . . . . . . . . 606 / 41
`10 / 2004 Knowlton
`606 / 41
`3 / 2011 Marchitto et al .
`
`OTHER PUBLICATIONS
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`2003 .
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`published 1999 .
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`Edition , Chapter 4 , pp . 46 - 71 , published 2012 , originally published
`1999 .
`Cameron , editor . “ Physical Agents in Clinical Practice , ” Physical
`Agents in Rehabilitation , 4th Edition , Chapter 2 , pp . 15 - 22 , pub
`lished 2012 , originally published 1999 .
`Cameron , editor . " Superficial Cold and Heat , ” Physical Agents in
`Rehabilitation , 4th Edition , Chapter 8 , pp . 129 - 172 , published 2012 ,
`originally published 1999 .
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`Agents in Rehabilitation , 4th Edition , Chapter 1 , pp . 1 - 14 , published
`2012 , originally published 1999 .
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`bilitation , 4th Edition , Chapter 5 , pp . 72 - 105 , published 2012 ,
`originally published 1999 .
`Franco et al . , “ Hyperthermic injury to adipocyte cells by selective
`heating of subcutaneous fat with a novel radiofrequency device :
`feasibility studies , ” Lasers Surg Med . , 42 ( 5 ) : 361 - 370 , Jul . 2010 .
`Klein , “ Deep Heat , ” emedicine . medscape . com [ online ] dated Sep .
`25 , 2008 . Retrieved from the Internet < URL : http : / / emedicine .
`medscape . com / article / 325046 - print > , retrieved on Jan . 27 , 2010 , 8
`pages .
`Leitgeb , “ Exposure of non - target tissues in medical diathermy , "
`Bioelectromagnetics , 31 ( 1 ) : 12 - 19 , Jan . 2010 .
`* cited by examiner
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`Applicator
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`c = 6 . 8 PF
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`generator
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`L - 200nh
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`LUMENIS EX1035
`Page 12
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`
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`US 10 , 271 , 900 B2
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`5
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`10
`
`INDUCTIVE HEATING OF TISSUES USING
`ALTERNATING MAGNETIC FIELDS AND
`USES THEREOF
`
`nation have been developed that employ ultrasound , high
`temperature plasma directed at the tissue , or radiofrequency
`electromagnetic fields .
`All of the current technology can result in deleterious
`effects in patients and create problems for the operators . For
`CROSS - REFERENCE TO RELATED
`example , laser radiant energy is potentially hazardous to the
`APPLICATION
`operator and precautions must be made to safely contain it ,
`This non - provisional application claims benefit of priority
`and patients often report burns resulting from laser treat
`of provisional application U . S . Ser . No . 60 / 922 , 249 , filed
`ments .
`Most radiofrequency devices work through capacitive
`Apr . 6 , 2007 , now abandoned .
`coupling whereby potentially hazardous electrical current
`passes through the patient ' s body , resulting in the creation of
`BACKGROUND OF THE INVENTION
`radiofrequency electric fields at the interfaces of tissues that
`Field of the Invention
`are weak - or non - polarity . This effect capacitive coupling
`The present invention relates generally to the fields of 15 can lead to burns at electrodes , and inadvertent heating of
`biomedical engineering , biochemistry , medical treatment ,
`collateral tissues , such as adipose tissue . This heating of
`and surgical procedures . More specifically , the present
`collateral tissues is an undesirable consequence for skin
`invention provides methods , devices , and compositions for
`rejuvenation that can result in atrophy , particularly in fat
`inducing changes in tissues , biomolecules , and bioactive
`layers in skin during cosmetic treatments . Further , genera
`molecules . These changes are notably useful for inducing 20 tion of smoke and charring of tissue is a common conse
`alterations in tissues , most notably in skin , for cosmetic
`quence of the use of electrosurgical devices . For example ,
`during surgery , an “ inadvertent capacitor ” can be created
`purposes .
`Description of the Related Art
`between a laparoscope and the electrosurgical probe , result
`ing in the creation of electrical currents where they are not
`Heating of tissue is a fundamental physical event in many
`different medical procedures . Depending on the time - tem - 25 expected .
`perature history of the tissue , a cascade of physical , chemi .
`The instant invention eliminates the risk of charring and
`cal , and biological events occurs when tissue is heated
`the generation of smoke , as it does not rely on capacitive
`These events can lead to a beneficial or deleterious response .
`coupling for its effects . The patient is isolated from the
`One example of a beneficial response is the reduction or
`electrical current in the devices and no electrical current is
`elimination of the appearance of skin wrinkles as a result of 30 conducted from the applicator or the patient . The invention
`heat induced tissue contraction .
`preferably is used for the direct heating of moist conductive
`tissues , such as the viable dermis during cosmetic skin
`Skin Wrinkles
`Skin wrinkles are often the consequence of advancing age
`treatment , and less efficiently for tissues of low hydration
`( e . g . stratum corneum ) , or of low polarity ( adipose ) , thereby
`and sun exposure . With increasing age and excessive sun
`exposure , skin quality deteriorates . This is due , in part , to
`35 providing a safer means for treating skin .
`changes in hydration and epidermal thickness , and on a
`Skin Cooling
`molecular scale , to a decrease in the amount of collagen in
`When viable tissues reach temperatures of 55 C to 60 C ,
`the dermis . Further , subcutaneous fat accumulates or atro -
`tissue necrosis may occur . This is one concern during laser
`phies leading to furrowing of the skin , which produces
`and radiofrequency cosmetic skin treatments . Thus , various
`wrinkles . In today ' s society , the appearance of skin wrinkles 40 methods of skin cooling are often employed ( Anderson , RR ,
`is often viewed negatively and so there is a desire in the
`2003 ) , including the spraying of cryogen on the skin surface
`community for a means to safely reduce or eliminate
`or on an applicator , or applying cold air , water or ice to the
`skin . One prior art method for the purpose of skin cooling is
`wrinkles .
`Skin Rejuvenation
`the application of ice cubes to the skin surface prior to laser
`For many years , wrinkles have been treated with chemical 45 treatment , ( Gilchrest et al . , 1982 ) . These treatments have not
`peels or mechanical dermabrasion , cosmetic medical proce -
`proven entirely satisfactory , nor more importantly led to an
`dures in which the surface of the epidermis of the skin ( the
`improved therapeutic response , that is improved blanching
`stratum corneum ) is removed chemically or by abrasion
`of the port wine stain , ( nevus flammeus ) , which is a vascular
`( sanding ) , respectively . In the late 1980s , laser ablation
`birthmark consisting of superficial and deep dilated capil
`procedures for skin resurfacing were developed and 50 laries in the skin that produce a reddish to purplish discol
`approved . Today they remain in use , but are being replaced
`oration of the skin .
`by laser procedures that are non - ablative and less damaging
`Other prior art attempts to provide surface cooling of the
`to surrounding tissues . The goal of these procedures includes
`epidermis using plastic bags filled with ice placed on the
`tissue contraction , or skin - tightening , as well as induction of
`skin surface for five minutes , compressed freon gas used
`a wound response that leads to the generation of new 55 during irradiation , or chilled water spread directly on the
`collagen , and hence , dermal thickening . In the mid to late
`area being irradiated have also been explored , ( Welch et al . ,
`1990s , another cosmetic technique for skin was developed
`1983 ) . However , these studies were done with pig cadaver
`that involves a non - ablative thermal alteration to skin . This
`tissue and normally utilized cooling periods of 2 to 14
`procedure , referred to as radiofrequency ( RF ) skin rejuve -
`seconds . The reported results with freon were good in only
`nation , is mediated through capacitive - coupling of radiof - 60 28 . 5 percent of the cases , in some cases , the skin surface was
`requency energy ( e . g . U . S . Pat . No . 7 , 189 , 230 ) , using modi -
`momentarily frozen , and in others , the freon jet was found
`fied electrosurgical devices .
`to overcool the skin surface .
`Radiofrequency rejuvenation can result in tissue contrac -
`Thus , the prior art is deficient in methods and devices for
`non - invasive and safer methods of skin rejuvenation induced
`tion as tissue structural proteins and proteoglycans thermally
`denature and coagulate . A second effect of this procedure is 65 by high frequency alternating magnetic fields that induc
`a beneficial wound response causing the production of new
`tively heat skin tissues . The prior art is also deficient in the
`collagen . More recently , additional devices for skin rejuve
`use of alternating magnetic fields to inductively heat con
`
`LUMENIS EX1035
`Page 13
`
`
`
`US 10 , 271 , 900 B2
`
`T he present invention is yet directed further still to a
`ductive dermal tissues with a high degree of specificity . The
`device for altering tissue incorporating a source of electro
`prior art is also deficient in methods and devices to target
`magnetic energy , an induction coil , a cooling system , an
`during the skin rejuvenation process only conductive dermal
`impedance matching network , and a means of controlling
`tissue and have little effect on fat and skin surface tissues .
`eed and 5 the process through feedback monitoring by detection of
`The present invention fulfills this longstanding need and 5
`eddy currents , or detection of an additional source of radiant
`desire in the art .
`energy , plasma energy , acoustic energy , bipolar electrosur
`gical energy , or monopolar electrosurgical energy .
`SUMMARY OF THE INVENTION
`Other and further aspects , features , and advantages of the
`The present invention is directed to a method of treatment 10 present invention will be apparent from the following
`description of the presently preferred embodiments of the
`of tissues in a subject , most notably for cosmetic treatment
`invention given for the purpose of disclosure .
`of skin . The method involves creating a high - frequency
`alternating magnetic field that , when directed in proximity
`BRIEF DESCRIPTION OF THE DRAWINGS
`with tissue , results in the production of heat through induc
`tive coupling with the tissue thus resulting in the desired 15
`So that the matter in which the above - recited features ,
`biologic effect . Representative examples of such biologic
`advantages and objects of the invention , as well as others
`effects include , but are not limited to coagulation , cauter
`that will become clear , are attained and can be understood in
`ization , tissue contraction or shrinkage , and induction of a
`detail , more particular descriptions of the invention briefly
`wound response that leads to biomolecular changes such as
`summarized above may be had by reference to certain
`the production of collagen by cells .
`20 embodiments thereof that are illustrated in the appended
`The present invention also is directed to methods to
`drawings . These drawings form a part of the specification . It
`coagulate tissue . The coagulation process may be beneficial
`is to be noted , however , that the appended drawings illus
`in ablating tissue , fusing tissue , and in improving skin
`trate preferred embodiments of the invention and therefore
`cosmesis .
`are not to be considered limiting in their scope .
`The present invention is directed further still to a method 25
`FIG . 1 depicts an applicator that transduces radiofre
`of monitoring the treatment process in tissue . The heating
`quency electrical energy into a magnetic field .
`process may be controlled by feedback monitoring and
`FIG . 2 depicts a hand piece incorporating a magnetic field
`adjustment of the heating process in accord to the results .
`applicator with optional cooling system .
`Methods of monitoring include , but are not limited to ,
`FIG . 3 depicts the endplate of the hand piece .
`detection heat generation , monitoring eddy current forma - 30
`FIG . 4 depicts a hand piece incorporating a solenoid - type
`tion in the tissue , ultrasound detection of tissue alterations or
`inductor and positioning of tissue using pneumatic pressure .
`changes in impedence in tissues that lead to an impedance
`FIG . 5 depicts a circuit diagram of the applicator .
`mis - match between the magnetic field applicator and the
`FIG . 6 shows measurements taken at 27 MHz and 600 W .
`radiofrequency generator .
`Bovine muscle , bovine fat , ovine skin , and human blood
`The present invention is yet directed further still to a
`35 were used for comparison . The tissues were cut to
`2 . times . 2 . times . 5 cm samples . Each sample was placed
`method of cooling the surface of the skin during a treatment
`with . The cooling method of the present invention preferably
`directly on the cap of the 27 MHz device and imaged from
`involves cooling of a thermally conductive surface in con -
`above with a Raytek IR thermometer . The device was
`tact with the skin . This may be accomplished by circulating
`activated and the time to heat was recorded . ( n = 3 for each
`coolant through the component in contact with the surface of 40 tissue type ) .
`the skin , or the contact component may be cooled by
`FIG . 7 shows porcine fat , muscle and skin were used for
`circulating coolant through the device coil component , or by
`comparison . The tissue samples were measured for thick
`directing cryogenic liquid or gas on the surface of the skin ,
`ness to ensure consistency between samples . The samples
`to the contact surface , or the device coil component , before ,
`were between 1 . 5 - 2 . 0 mm in thickness . The samples were
`45 placed on the faceplate which is 4 mm thick PVC and
`during or after treatment .
`The present invention is directed further still to a method
`imaged from above with a Raytek IR thermometer . The
`device was turned on and the time for the sample to reach
`of inducing a beneficial wound response in tissue by expos
`ing the tissue to a high - frequency alternating magnetic field
`70 . degree . C . was recorded . The IR thermometer is limited
`that induces the movement of charged species within the
`to recording the tissue surface opposite that which is in
`tissue leading to various biologic responses , some of which 50 contact with the device . Therefore , it is believe that the
`are induced by the concomitant production of heat in the
`actual temperature of the tissue was greater than indicated
`tissue . One beneficial would response is the production of
`on the graph .
`new collagen in the skin and dermal thickening .
`FIG . 8 shows biopsied samples at each time point dem
`The present invention is yet directed further still to a
`onstrating a thickening of the dermis as compared to
`device for altering tissue incorporating a source of electro - 55 untreated controls .
`magnetic energy , a cooling system , an induction coil , an
`FIG . 9 shows biopsied samples at each time point dem
`impedence matching network , and optionally , a means of
`onstrating a production of neo - collagen in treated tissues as
`controlling the process .
`compared to the untreated controls .
`The present invention is directed further to a device for
`FIG . 10 shows a model of the expected mode of action
`treating tissue incorporating a hand piece coupled to the 60 produced by inductive heating on collagen within the treated
`energy output of a radiofrequency generator , whereby the
`tissues .
`hand piece incorporates an impedance matching network , a
`cooling system , and optionally a feedback mechanism to
`ensure proper treatment of the tissue . Optionally , a mechani
`cal or pneumatic tissue - shaper , which can manipulate the 65
`tissue into a beneficial position and shape proximal to the
`hand piece is incorporated .
`
`DETAILED DESCRIPTION OF THE
`INVENTION
`One embodiment of the present invention provides a
`method of treatment for one or more tissue in an individual ,
`
`LUMENIS EX1035
`Page 14
`
`
`
`15
`
`US 10 , 271 , 900 B2
`comprising positioning an alternating magnetic field in
`Cooling Endplate
`proximity of the tissue , inducing heat therein , and thereby
`FIG . 3 shows a view of an endplate 3550 on the distal end
`of the hand piece housing 3500 . The endplate is in intimate
`effecting treatment .
`Radiofrequency Power Supply
`thermal contact with the coil 2280 , which has circulating
`The invention consists of a source of radiofrequency ( RF ) 5 refrigerant within , and so the endplate is cooled . This
`electrical energy , normally a radiofrequency generator such
`coolant may optionally be supplied from a circulating chiller
`as sold by Comdel , Inc . ( e . g . CV1000 or CV500 , 40 . 68
`utilizing water and antifreeze . Alternatively , gas such as air ,
`MHz ; Gloucester , Mass . ) . The electrical output of the gen -
`nitrogen , freon , R - 12 , R - 134a , and carbon dioxide could
`erator is coupled to an applicator consisting of an inductor
`serve the purpose of cooling . Keeping in mind that the
`in the form of a coil ( for the generation of a magnetic field ) , 10 disposable shield 3350 is very thin and / or is highly ther
`which is further part of an impedance matching network that
`mally conductive , it serves to cool the skin before , during
`may additionally comprise a capacitor . In some cases appli
`and / or after the treatment in order to limit the heating of the
`cator may include an antenna ( for the production of an
`very superficial skin and increase comfort for the subject .
`electrical field ) . The source of energy used may be a constant
`FIG . 3 also shows an optional Faraday shield 3450 , which is
`current or a constant voltage power supply or may be a
`a conductive element intended to reduce capacitive coupling
`modulated current or a modulated voltage power supply . The
`of coil to the subject , and so to minimize any stray electric
`power - supply is able to produce radiofrequency energy with
`field . Note that the cooling endplate may be in intimate
`a power in the range 10 - 10 , 000 W and , depending on the
`contact with the coil in order to provide optimal thermal
`application , may be more preferably in the range of about
`conduction . This may be accomplished by molding or by
`100 to about 1000 W . The power - supply may typically 20 forming the plate around the coil . As shown in FIG . 2 ,
`operate at frequencies of 100 kHz to 2 . 4 GHz . Preferably the
`cooling of the skin may be realized by spraying the skin with
`frequency range is about 100 kHz to about 5 . 8 GHz and ,
`a coolant before , during or after treatment .
`more preferably , the frequency range is at or near , or
`Pneumatic Applicator
`between 415 kHz to 4 MHz , 13 . 56 MHz , 27 . 12 MHz , 40 . 68 ,
`FIG . 4 shows a partial view of an applicator incorporating
`67 . 8 MHz , 95 MHz , 433 . 92 , 915 MHz , 2 . 4 GHz . The 25
`a two - turn solenoid coil 4150 , the bore of which surround
`power - supply may optionally be one used in electrosurgery .
`tissue 4260 which extrudes from the skin 4300 up into the
`Beneficially , the radiofrequency generator should be fre -
`bore as a result of negative pneumatic pressure within the
`quency - agile ; that is , as the impedance of the load changes
`housing 3500 . As the magnetic field within the turns of a
`somewhat , the frequency output of the radiofrequency gen -
`solenoid is very much stronger than the field outside of a
`erator changes slightly to provide a better impedance match 30 pancake coil , and the geometry of the tissue within the bore
`between the load and generator and so to maintain the output
`is different than illustrated in FIG . 2 , the power required to
`obtain an effect is reduced and the effect on tissue can be
`power within a controllable tolerance .
`Applicator
`more beneficial .
`FIG . 1 is a sectional view of an applicator used to produce
`Combined Devices
`In some aspects of this embodiment , the treatment may be
`a magnetic field . A center copper tube 2220 , which serves to 35
`conduct the radiofrequency electricity but also as an input
`inductive , or conductively or radiatively applied in combi
`for refrigerant , is surrounded by a TEFLON® cylinder 2240 .
`nation with the use of an alternating magnetic field . Addi
`Endcaps 2230 and 2270 serve to position and hold the
`tionally , the energy may be pulsed in order to improve the
`copper tube within the TEFLON® cylinder . The center
`thermal kinetics of the tissue heating . Examples of applied
`copper tube 2220 is formed at the distal end of the applicator 40 energy are radiofrequency energy , radiant energy , or vibra
`into a coil , 2280 , which then is fixed parallel 2320 with the
`tional energy . The radiofrequency energy may have a fre
`center copper tube and directed to an exit 2210 out of the
`quency from about 20 kHz to about 40 GHz , and may be
`applicator ; the coolant is directed out through exit 2210 . In
`applied using coils , electrodes or one or more antennae . The
`order to provide impedance matching between the radiofre
`radiant energy may have a wavelength from about 600 nm
`quency generator and applicator , a ceramic insulator 2310 is 45 to 11 m . The vibrational energy may be sonic or ultrasonic
`positioned around the TEFLON® cylinder 2240 . The
`with a frequency from about 20 Hz to 80 MHz . In the case
`ceramic insulator has two capacitor rings , 2330 and 2260 ,
`of inductive heating , the energy may not be incident on the
`made up of copper pipe . The pipe 2320 is in electrical
`target , but may be induced in the target to be converted from
`contact with the capacitor rings . By adjusting the spacing
`one form to another .
`2250 between the two capacitor rings , the impedance match 50
`In certain aspects , combined devices , using induction plus
`between the radiofrequency generator and applicator can be
`an energy source ( e . g . laser or ultrasound ) may enhance the
`effected . The applicator is encased in a copper cylinder 2450
`effects or be used to combine certain treatments . Because the
`attached to the ground shield of the coaxial wire in order to
`interaction of laser energy and ultrasound waves with tissue
`shield any stray radiated radiofrequency .
`is physically different than the present invention , it is
`HandPiece
`55 anticipated that a different effect can be elicited . An appli
`cator of radiant energy may consist of an optical assembly ,
`FIG . 2 shows a