CA2526671A1

CA2526671A1 - Improved system and method for heating biological tissue via rf energy

Info

Publication number: CA2526671A1
Application number: CA002526671A
Authority: CA
Inventors: Ziv Karni; Alexander Britva
Original assignee: Msq Ltd.; Ziv Karni; Alexander Britva; Alma Lasers Ltd.
Current assignee: Alma Lasers Ltd
Priority date: 2005-01-18
Filing date: 2005-03-17
Publication date: 2006-07-18
Anticipated expiration: 2025-03-17
Also published as: CA2526671C; CN101160103A; WO2006077567A1; KR101319453B1; KR20080004452A; ES2383376T3; US20120239120A1; WO2006077582A2; JP2008526421A; EP1715810A4; US8150532B2; JP2008526423A; KR100895939B1; ATE556745T1; BRPI0606120A2; EP1715810A1; US20090326528A1; WO2006077582A3; KR20060103814A; US7630774B2

Abstract

A system 30 and method(s) 100 for thermal treatment of a selected target within a subject is disclosed. System 30 includes RF source 10, phase shifter 14, impedance matching network 11 and resonator 13. Applicator 3 conveys output signal 17 from energy source 10 through surface 6 of biological tissue 4 to predetermined energy dissipation zone 5 after output 17 has been processed by the phase shifter 14, IMN 11 and resonator 13. Stationary water molecules 1, such as those in fat cells, are preferentially heated. Operation of system 30 produces a reverse thermal gradient so that surface 6 of biological tissue 4 is maintained at a lower temperature than predetermined energy dissipation zone 5 without a cooling device. The invention is useful in selective heating of cellulite bodies as a means of treating cellulite.

Description

IMPROVED SYSTEM AND METHOD FOR HEATING
BIOLOGICAL TISSUE VIA RF ENERGY
FIELD AND BACKGROUND OF THE INVENTION
The present invention relates to an improved system and method for heating biological tissue via RF energy and, more particularly, to a system and method which rely upon a single electrode. Control of phase and pulse width modulation of applied RF
waves obviate the need for cooling of the skin surface while facilitating efficient heating of underlying layers of tissue such as dermis and subcutaneous layers. Specif cally, heating and contraction of adipose tissues as a means of cellulite reduction is achieved.
Adipose tissues, particularly cellulite, are typically treatable only with a strict regimen of diet and exercise. Patient compliance with these previously available regimens is poor. Cellulite occurs when fat cells swell compressing the flow of blood and I S lymph. This leads to build-up of fluid and toxins. Connective tissue forms hard fibrous capsules around the fat cells. This results in a "lumpy" appearance. The fat cells involved are located primarily in the third and most deep (skin) layer, which has a variable by thickness depending on the amount fat in the subject. Thickness of this layer typically increases in areas such as abdomen, thighs and buttocks.
Previously proposed methods for cellulite treatment include Topical treatment, Teas and capsules, Cellulite wraps, Endermologie, Mesotherapy, Acthyderm and Ultrasonic and particularly focused ultrasonic treatment. These techniques have not demonstrated clinical efficacy in reducing the "lumpy" appearance associated with cellulite deposits.
In addition, thermotherapy using electromagnetic radiation or radio-frequency (RF) waves has been proposed. RF treatment is more effective than other available therapy regimens since it permits the body to heal itself. However, previously available thermotherapy solutions share, as an inherent disadvantage, a tendency to heat the skin to the point of causing a burn when sufficient RF energy is applied to heat the fat cell target in the deepest skin layer. .
The currently accepted RF technique for heating of biological tissues involves exposing the tissue to RF voltage, which produces RF conductive current through the tissue at a level su~cient to overcome the tissue resistance. The current heats the tissue.
This method causes uneven heat accompanied by burning of the outer layers) the skin.
As a result, systems for implementation of this method share, as an inherent disadvantage, a strict requirement for a cooling mechanism to remove an excessive heat of the skin during the treatment.
Previously available alternatives are characterized by disadvantages which are obviated by the present invention.
One example of a prior art systems) is disclosed in US Patent No. 6,662,054 assigned to Syneron Medical Ltd. This patent teaches deforming the skin so that a region of skin protrudes from the surrounding skin; and applying RF energy to the protruded skin. The system includes one or more RF electrodes, configured to apply conducted RF
current to the skin, and a skin deformer, so that a region of skin protrudes out from surrounding skin and is exposed to the conducted RF current, which follows the deforming act. Teachings of this patent have, as an inherent disadvantage, a strict requirement for cooling of the skin to prevent burning.
Additional examples of prior art systems which require cooling of the skin to prevent burning include those disclosed in US Patent Application No.

assigned to Thermage, Inc. which teaches a method of creating a tissue effect by delivering electromagnetic energy through a skin surface from an electromagnetic energy delivery device coupled to an electromagnetic energy source. At least one of the electromagnetic energy delivery device or electromagnetic energy source includes a memory. A reverse thermal gradient is created through the skin surface to sufficiently heat an underlying tissue site to provide that the temperature of the skin surface is lower than the temperature of the underlying tissue. The reverse thermal gradient is established by use of a cooling system, which is an inherent disadvantage.

Further additional examples of prior art systems which require cooling of the skin to prevent burning include those disclosed in US Patent Application No.
2004030332 and US Patent No. 5919219 assigned to Thermage, Inc., which teach a system and method for providing treatment to a skin surface by applying RF energy through the skin using a memory for gathering information. These systems include, as an inherent disadvantage, a strict requirement for a cooling lumen for receiving cooling fluid and a number of RF
electrodes. The RF electrodes are provided to transfer RF current to the skin and are configured to be capacitive coupled to the skin surface, thus creating a heating effect through RF conducted current.
In sununary, all previously available methods require the use of a cooling system to cool the outer skin layer throughout the RF treatment. Further, many of the previously available solutions require a memory unit to store local information pertaining to the treated area throughout the treatment. Further, many of the previously available solutions require extensive preliminary adjustments; such as local impedance matching, prior to each treatment. Further, despite use of the phrase "one or more electrodes in many prior art documents, all previously available alternatives share, as an inherent disadvantage, a strict requirement for a return electrode to receive the RF currents after passing tissue being treated. This return electrode for volumetric treatment of adipose tissue (e.g.
cellulite) routes a majority of energy through blood and lymphatic vessels.
Fat cells are heated only by heat dissipated from these non-target tissues as a result of their inherent resistance.
There is thus a widely recognized need for, and it would be highly advantageous to have, an improved system and method for heating biological tissue via RF
energy devoid of the above limitation(s).
SUMMARY OF THE INVENTION
According to one aspect of the present invention there is provided a system for RF
(I~) energy treatment of deep layers of human tissue (e.g.dermis and/or hypodermis) to achieve adipose tissue contraction and/or cellulite reduction.

The system includes an RF-energy applicator (e.g.spherical shape) which serves as RF-energy coupling antenna that functions in combination with an adjacent tissue as a losses transmission line when contacted with epidermis of the tissue.
The system further includes a treated area (part) of human tissue placed in direct contact with RF-energy applicator whereas underlying subcutaneous tissues acts as a dissipative load of the said applicator and the transmission line.
The system further includes a parallel resonance circuit (RF-resonator) including inductor and capacitor and maximally closely contacted with the said applicator by its central point whereas merit factor of this resonant circuit must be sufficiently high that provides active losses determined by equivalent resistance, which is at least 20 times higher that modulus of impedance of a said area of attached human tissue The system further includes impedance matching network (IMI~ converting the impedance of treated area of human tissue into 50 Ohms in order to minimize reflected power from human tissue and provide a traveling wave through a human tissue.
The system further includes a phase shifting device at the input of the lNlT1 providing an achievement of maximum of RF traveling -wave at a predetermined depth under the surface or on the surface.
According to another aspect of the present invention there is provided a method, which includes operation of the system.
According to further features in preferred embodiments of the invention described below the applicator is made from Al, Ag, Au, copper, or copper and aluminum alloys and coated with dielectric material.
According to still further features in the described preferred embodiments the applicator is made from A1 coated by alumina.
According to still fiirther features in the described preferred embodiments the applicator is moved on the surface of treated skin.
According to still further features in the described preferred embodiments the feeding cable connects RF- applicator and RF-resonator with impedance matching systems.

According to still further features in the described preferred embodiments the feeding cable has resonance (n*~,/2) length, where 7~- is a wavelength of RF-energy in the cable material and n - is whole number According to still further features in the described preferred embodiments the impedance matching system provides compensation of the reactance of the attached piece of human tissue.
According to still further features in the described preferred embodiments the impedance matching system is fixed L, T or lI shape structure.
According to still further features in the described preferred embodiments the IO impedance matching system is broadband impedance transformer.
According to still further features in the described preferred embodiments the impedance matching system is vaxiable.
According to still further features in the described preferred embodiments the phase shifter is trombone type.
15 According to still further features in the described preferred embodiments the phase shifter is constructed of coaxial cable.
According to still further features in the described preferred embodiments the phase shift provided by the phase shifter is variable in time.
According to still further features in the described preferred embodiments the 20 impedance meter (sensor) is inserted between matching system and RF-applicator.
According to still further features in the described preferred embodiments the said impedance matching system is controllable by feedback system obtaining the signal from the said impedance meter (sensor) for the purpose of reaching the optimal impedance matching and maximal energy deposition into human tissue.
25 According to still further features in the described preferred embodiments the coupled energy is delivered from RF-generator (amplifier).
According to still further features in the described preferred embodiments the delivered RF-power is coupled in continuous or pulsing mode.

According to still fizrther features in the described preferred embodiments the control of the energy coupled to human tissue is achieved by variation of amplitude or duty cycle of RF-power in pulsing mode (PWM- control).
According to still further features in the described preferred embodiments the certain part of human body is in contact with second point of the said RF-resonator (for example ground).
According to still further features in the described preferred embodiments the operation is provided on the resonance frequency of human body.
According to still further features in the described preferred embodiments the treatment with RF-applicator t is combined with the laser treatment.
According to still further features in the described preferred embodiments the treatment with RF-applicator t is combined with ultrasonic treatment According to still further features in the described preferred embodiments the treatment with RF-applicator t is combined with LTV-treatment According to still further features in the described preferred embodiments the treatment with RF-applicator t is combined with plasma treatment According to still further features in the described preferred embodiments the treatment with RF-applicator t is combined with flash-lamp treatment.
According to one aspect of the present invention there is provided an improved system for thermal treatment of a selected target within a subject, the system includes: (a) an RF energy source capable of producing an output RF power signal directed to an applicator contactable with a surface of a biological tissue belonging to the subject, the applicator capable of delivering a desired amount of energy to a predetermined energy dissipation zone beneath the surface of the biological tissue, the selected target positioned within the predetermined energy dissipation zone; (b) a phase shifter, the phase shifter capable of shifting a phase of directed traveling waves of the output signal so that energy therefrom is concentrated primarily in the predetermined energy dissipation zone, which lies at a desired depth beneath the surface of the biological tissue; (c) an impedance matching network (IMN), the IMN capable of converting the impedance of the biological tissue belonging to the subject from a nominal value to a corrected value, the corrected value matching an impedance characteristic of the RF transmission line so that the directed traveling wave may pass through the surface of the biological tissue without being converted to a standing wave; (d) an 1ZF resonator located in the applicator, the RF
resonator capable of cyclically accumulating and releasing the desired amount of energy, the RF resonator further capable of concentrating the desired amount of energy so that a significant portion thereof is concentrated in the predetermined energy dissipation zone;
and (e) the applicator capable of conveying the output RF power signal from the RF
energy source through the surface of the biological tissue to the predetermined energy dissipation zone after the output has been processed by the phase shifter, the IMN and the resonator. Operation of the system produces a reverse thermal gradient so that the surface of the biological tissue is maintained at a lower temperature than the predetermined energy. The absence of a ground electrode permits free propagation of the waves of the output RF power signal in the energy dissipation zone.
According to another aspect of the present invention there is provided an improved method for thermal treatment of a selected target within a subject. The method includes:
(a) providing an output RF power signal directed to an applicator contactable with a surface of a biological tissue belonging to the subject, (b) employing a phase shifter to shift a phase of directed traveling waves of the output RF power so that energy therefrom is concentrated primarily in a predetermined energy dissipation zone which lies at a desired depth beneath the surface of the biological tissue, wherein the selected target is positioned within the predetermined energy dissipation zone; (c) converting the impedance of the biological tissue belonging to the subject from a nominal value to a corrected value, the corrected value matching an impedance characteristic of RF-transmission line so that the directed traveling wave may pass through the surface of the biological tissue without being converted to a standing wave by means of an impedance matching network (IMl~; (d) cyclically accumulating in an RF resonator located in the applicator, and releasing therefrom, the desired amount of energy, (e) concentrating the desired amount of energy in the RF resonator so that a significant portion thereof is concentrated in the predetermined energy dissipation zone upon release therefrom; and (f) conveying the output signal of RF energy through the surface of the biological tissue to the predetermined energy dissipation zone after the output has been processed by the phase shifter, the IMN and the resonator by means of the applicator.
Performance of (a) -(f) produces a reverse thermal gradient so that the surface of the biological tissue is maintained at a lower temperature than the predetermined energy dissipation zone, thereby obviating the need for a cooling device. The absence of a ground electrode permits free propagation of the waves in the output signal in the energy dissipation zone.
According to yet another aspect of the present invention there is provided an improved method for cellulite treatment. The method includes: (a) providing an output signal of RF energy directable to an applicator contactable with a surface of a biological tissue belonging to the subject, (b) employing a phase shifter to shift a phase of directed traveling waves of the output RF power so that energy therefrom is concentrated primarily in a predetermined energy dissipation zone which lies at a desired depth beneath the surface of the biological tissue, wherein the selected target is positioned within the predetermined energy dissipation zone, the predetermined energy dissipation zone including at Ieast one cellulite body; (c) converting the impedance of the biological tissue belonging to the subject from a nominal value to a corrected value, the corrected value matching an impedance characteristic of 1RF-transmission line so that the directed traveling wave so that the output signal may pass through the surface of the biological tissue without being converted to a standing wave by means of an impedance matching network (I~; (d) cyclically accumulating in an RF resonator located in the applicator, and releasing therefrom, the desired amount of energy, (e) concentrating the desired amount of energy in the RF resonator so that a significant portion thereof is concentrated in the predetermined energy dissipation zone upon release therefrom; and(f) conveying the output power from the RF energy source through the surface of the biological tissue to the predetermined energy dissipation zone after the output has been processed by the phase shifter, the IMN and the resonator by means of the applicator.
Performance of (a) ~f) produces a reverse thermal gradient so that the surface of the biological tissue is maintained at a lower temperature than the predetermined energy dissipation zone, thereby obviating the need for a cooling device. The absence of a ground electrode permits free propagation of the waves in the output signal in the energy dissipation zone.
The at least one cellulite body is heated to a greater degree than a tissue adjacent thereto.
According to further features in preferred embodiments of the invention described below, the system further includes a pulse width modulation (PWM)- controller, the PWM- controller capable of causing the RF energy source to deliver the output signal in pulses of a desired amplitude, a predetermined duration with a desired repetition frequency for average output power control.
According to still further features in the described preferred embodiments the system further includes a dielectric barrier positionable between the applicator and the surface of the biological tissue; the dielectric barrier preventing transmission of a conductive current.
According to still further features in the described preferred embodiments the applicator is made from at least one metal selected from the group consisting of aluminum; silver, gold, copper and alloys thereof.
According to still further features in the described preferred embodiments the dielectric barrier is supplied as a dielectric coating on the applicator.
According to still further features in the described preferred embodiments the applicator is constructed primarily of aluminum and the dielectric barrier is supplied as an alumina coating.
According to still further features in the described preferred embodiments the applicator is movable on the surface of the biological tissue as a means of altering a location of the energy dissipation zone.
According to still further features in the described preferred embodiments the system further includes a feeding cable, the feeding cable connecting the RF-applicator and the RF-resonator with the IMN.

According to still further features in the described preferred embodiments the feeding cable has a resonance length defined by n*~,/2 length, where ~, is a wavelength of RF-energy in the cable material and n is a whole number.
According to still further features in the described preferred embodiments the IMN
includes a fixed structure characterized by a shape selected from the group consisting of L shaped, T shaped and II shaped structure.
According to still further features in the described preferred embodiments the ININ
includes a broadband impedance transformer.
According to still further features in the described preferred embodiments the IMN
is variable.
According to still further features in the described preferred embodiments the phase shifter includes a trombone type phase shifting mechanism. Trombone type phase shifters are well known to those of ordinary skill in the art and are described in detail at www.microwaves101.com/encyclopedia/phaseshifters.cfm which is fully incorporated herein by reference (see Appendix A).
According to still further features in the described preferred embodiments the phase shifter is at least partially constructed of coaxial cable.
According to still further features in the described preferred embodiments a phase shift provided by the phase shifter is variable.
According to still further features in the described preferred embodiments the energy delivered to the predetermined energy dissipation zone is coupled in continuous or pulsing mode. The RF-energy is produced in the form of sinusoidal signal that can be modulated by rectangular pulses with Iower frequency by PWM controller) According to still further features in the described preferred embodiments the RF-energy is characterized by a resonance frequency which matches a known natural resonance frequency of the selected target According to still further features in the described preferred embodiments the system further includes at least one additional component selected from the group consisting of a laser beam, an ultrasonic transducer, a UV light source, a plasma treatment device and a flash lamp.
According to still further features in the described preferred embodiments the providing indicates provision of the output signal in pulses of a predetermined duration with a desired frequency.
According to still further features in the described preferred embodiments the method further includes interposing a dielectric barrier between the applicator and the surface of the biological tissue. The dielectric barner prevents transmission of a conductive current.
According to still further features in the described preferred embodiments the method further includes constructing the applicator primarily of aluminum.
More preferably, the dielectric barrier is supplied as an alumina coating on an aluminum applicator.
According to still further features in the described preferred embodiments the method further includes moving the applicator with respect to the surface of the biological tissue as a means of altering a location of the energy dissipation zone.
According to still further features in the described preferred embodiments the method further includes employing a feeding cable to connect the RF-applicator and the RF-resonator with the IMN.
According to still further features in the described preferred embodiments the method further includes varying the phase shift provided by the phase shifter.
The present invention successfully addresses the shortcomings of the presently known configurations by providing an improved system and method for heating biological tissue via RF energy, which relies upon a single electrode and does not require a cooling system to prevent burning of skin.
Implementation of the method and system of the present invention involves performing or completing selected tasks or steps manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present invention, selected steps could be implemented by hardware or by software on any operating system of any firmware or a combination thereof. For example, as hardware, selected steps of the invention could be implemented as a chip or a circuit. As software, selected steps of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected steps of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.
In the drawings:
FIG. 1 is a simplified schematic diagram illustrating RF-power coupling to a treated tissue according to the present invention.
FIG. 2 is simplified schematic diagram of RF-system according to the present invention illustrating the principles of output power control with PWM and treating space control with phase shifting of incident RF-wave in accordance with a preferred embodiment of the present invention FIG. 3 illustrates an impedance matching system in accordance with the present invention.

FIG. 4 is a thermo-gram illustrating heat distribution resulting from operation of a system according to the present invention using a slice of an apple as a target.
FIG. 5 is a thermo-gram illustrating heat distribution resulting from operation of a prior art system according to the present invention using a slice of an apple as a target.
FIG. 6 is a simplified flow diagram illustrating a sequence of events associated with performance of a method according to the present invention.
BRIEF DESCRIPTION OF PREFERRED EMBODIMENTS
The present invention is of an improved system and method for heating biological tissue via RF energy, which requires only a single electrode.
Specifically, control of phase and pulse with modulation (PWM)-control of applied RF
waves through the single electrode of the present invention obviate the need for cooling of the skin surface while facilitating efficient heating of underlying layers of tissue such as dermis and subcutaneous layers. As a result, the desired heating and contraction of adipose tissues is achieved. This allows, for the first time, non-invasive cellulite reduction.
The principles and operation of an improved system and method for heating biological tissue via RF energy according to the present invention may be better understood with reference to the drawings and accompanying descriptions.
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. In addition, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
The present invention offers several advantages with regard to previously available alternatives.

A single electrode, or applicator, employed without a ground electrode permits homogeneous application of RF-energy, which is directed primarily towards rotation, and vibration of dipole molecules, especially water molecules, in the applied electromagnetic wave.
S Phase shifting techniques provide the possibility of concentration of RF-energy at a predetermined depth with respect to the skin surface by variation of position of RF-wave maximum Organization of energy dissipation inside of subcutaneous tissue insures maintenance of a relatively low temperature on the skin surface (epidermis).
This provides a reverse thermal gradient without use of an external cooling system.
Preferably, an Alumina- ceramic-coated applicator minimizes energy losses and prevents unwanted conductive current through human tissue A supporting parallel resonator attached in proximity to the applicator accumulates RF-energy and provides efficient excitation of the applicator and high RF-voltage on the application surface.
Application of high RF-power in short-pulses provides fast and effective heating of cellulite capsules with relatively low average RF-power level.
PWM-control of output RF-power and simple IMN techniques provide good matching and low RF-power reflection with all types of human tissues. The additional advantage of applied fixed IMN and PWM-control ensure good impedance matching with variable types of human tissue without complicated impedance matching correction.
The RF-applicator can be moved on the treated surface.
It will be appreciated that volumetric fatty tissue treatment requires deployment of a homogeneous RF-wave (through cross-section transversal to wave propagation) with maximum at a desired distance from the electrode-applicator. This homogeneous and high intensity 1RF-wave insures efficient heating of cellulite capsules and fat cells because they retain water molecules. In contrast, blood and lymphatic vessels will not be subject to undesired heating because the natural circulation of water molecules in these vessels provides convective cooling. Further, blood and lymphatic vessels provide conductive cooling for other non-target tissues such as muscle, nerve tissue and connective tissue.
Referring now to the- figures, principle components of a system according to the present invention and their operation are explained in greater detail.
The present invention is primarily embodied by a system 30 (Figures 1-3) for thermal treatment of a selected target within a subj ect. System 30 includes an RF energy source 10 capable of producing an output RF power signal 17 directed to an applicator 3 contactable with a surface 6 of a biological tissue 4 belonging to the subject. Applicator 3 is capable of delivering a desired amount of energy to a predetermined energy dissipation I O zone 5 beneath surface 6 of biological tissue 4. The selected target is positioned within the predetermined energy dissipation zone 5 and is represented in the figures as water molecules 1.
System 30 further includes a phase shifter (e.g. trombone-type phase shifter 14).
Phase shifter 14 is capable of shifting a phase of directed traveling waves of output 15 powerl7 so that energy therefrom is concentrated primarily in the predetermined energy dissipation zone 5, which lies at a desired depth beneath surface 6 of biological tissue 4.
System 30 further includes an impedance matching network I1 (IMN capable of converting the impedance of biological tissue 4 belonging to the subject from a nominal value (e.g. 250-350 Ohms) to a corrected value (e.g. 50 Ohms). The corrected value 20 matches an impedance characteristic of RF energy source and RF transmission line including phase shifter 14 and cable 11, so that output RF traveling wave 17 may pass through surface 6 of biological tissue 4 without being converted to a standing wave.
System 30 further includes an RF resonator 13 located in applicator 3. , RF
resonator 13 is capable of cyclically accumulating and releasing the desired amount of 25 energy and is further capable of concentrating the desired amount of energy so that a significant portion thereof may be transmitted to predetermined energy dissipation zone 5.
System 30 further includes applicator 3 capable of conveying output RF power signal 17 from the RF energy source 10 through surface 6 of biological tissue 4 to predetermined energy dissipation zone 5 after output 17 has been processed by the phase shifter I4, IMN I1 and resonator 13.
Typically, operation of system 30 results in 2 to 4% loss of energy from output signal I7 with ban additional 2-4% reflection of energy from output signal 17.
This means that system 30 can reliably deliver 90-95% of energy from output signal 17 into zone 5. Neither concentration of energy from output signal 17 into a small zone 5, nor this degree of efficiency, were achievable with previously available alternatives. IMN 11 reduces reflection of applied output signal I7 from surface 6 thereby increasing efficiency of delivery of energy to energy dissipation zone 5.
It is an inherent advantage of system 30 that its operation produces a reverse thermal gradient so that surface 6 of biological tissue 4 is maintained at a lower temperature than predetermined energy dissipation zone 5 without use of a cooling device.
Further, the absence of a ground electrode from system 30 permits free propagation of the waves of output RF power signal 17 in energy dissipation zone 5.
These factors serve to greatly increase the degree of heating of water molecules 1 relative to the degree of heating of water molecules 1 achieved with prior art alternatives.
The inherent advantages of system 30 are clear from comparison of thermo-grams of energy dissipation zone 5 using system 30 (Figure 4) and a prior art bipolar (i.e. 2 electrode) system (Figure 5). Each thermo-gram is accompanied by a key on the left which indicates that the colors white, yellow, orange, red, green, blue and violet represent concentrations of heat energy in decreasing order. In each figure, an apple slice is used as biological tissue 4. Specif cally, it is clear that system 30 moves zone 4 away from surface 6 of tissue 4.
Figure 4 clearly shows that when applicator 3 of system 30 is contacted with surface 6 of tissue 4, delivery of output energy 17 results in delivery of energy primarily to zone 5. Line 26 passes through the center of zone 5. The temperature at surface 6 of tissue 4 is clearly lower than along line 26 in zone 5. In other words, operation of system 30 creates a reverse thermal gradient and obviates the need for a cooling system to prevent undesired overheating of surface 6.
In sharp contrast, Figure 5 clearly shows that when applicator 3 of a prior art bipolar system is contacted with surface 6 of tissue 4, delivery of output energy 17 results in delivery of energy primarily to a zone 5 which is adjacent to surface 6 of tissue 4. This reduces the distance between line 26, which passes through the center of zone 5, and surface 6. In other words, the prior art bipolar system delivers heat energy primarily in proximity to surface 6. The thermo-gram of Figure 5 illustrates a distribution of heat energy observed when the prior art bipolar system is operated with a cooling system.
Despite this cooling system, no reverse thermal gradient is achieved.
Optionally, but preferably, system 30 further includes a PWM controller, the PWM controller 12 capable of causing the RF energy source to deliver the output power signal in pulses of a predetermined duration and amplitude with a desired frequency. For example, the operating RF-frequency is 40.68 MHz, a PWM-frequency is 1 to 20 kHz and a duty cycle is 10 to 90 %.
According to some preferred embodiments of the invention, applicator 3 is made from metals such as, for example, aluminum, silver, gold, copper or alloys thereof.
Alternately, or additionally, a dielectric barrier 2 may be positioned between applicator 3 and surface 6 of biological tissue 4. Dielectric barrier 2 prevents unwanted transmission of a conductive current to tissue 4. According to some preferred embodiments of the invention, dielectric barrier 2 is supplied as a dielectric coating on applicator 3.
According to a most preferred embodiment, applicator 3 is constructed primarily of aluminum and dielectric barrier 2 is supplied as an alumina coating.
Optionally, but preferably, applicator 3 is movable on surface 6 of biological tissue 4 as a means of altering a location of energy dissipation zone 5.
Optionally, but preferably, system 30 further includes a feeding cable 7, the feeding cable 7 connecting RF- applicator 3 and the RF-resonator 13 with IMN
11.
Optionally, but preferably, feeding cable 7 has a resonance length defined by n*7~/2 length, where ~, is a wavelength of RF-energy in the cable material and n is a whole number.
Optionally, but preferably, IMN 11 includes a fixed structure characterized by a shape such as, for example, L shaped, T shaped or II shaped structure.
Optionally, but preferably, IMN 11 includes a broadband impedance transformer. Optionally, but preferably, IMN 11 is variable.
Optionally, but preferably, phase shifter 14 includes a trombone type phase shifting mechanism.
Alternately, or additionally, phase shifter 14 may be at least partially constructed of coaxial cable.
Optionally, but preferably, phase shifter 14 provides a variable phase shift.
.
Optionally, but preferably, RF-generator 10 delivers coupled energy.
Optionally, but preferably, the energy delivered to the predetermined energy dissipation zone 5 is coupled in a continuous or a pulsing mode. RF-generator produces output 17 in the form of a sinusoidal signal which may be modulated by rectangular pulses with lower frequency. This may be accomplished, for example, by PWM controller 12.
According to one most preferred embodiment of the invention, system 30 employs RF-energy 17 which is characterized by a resonance frequency that matches a known natural resonance frequency of the selected target.
Optionally, but preferably, system 30 may further include additional components, such as, for example, a laser beam, an ultrasonic transducer, a UV light source, a plasma treatment device and a flash lamp.
The present invention is further embodied by an improved method 100 for thermal treatment of a selected target within a subject. Method 100 includes:
providing 102 output RF power signal 17 directed to applicator 3 contactable with surface 6 of biological tissue 4 belonging to the subject.
Method 100 includes employing 104 a phase shifter 14 to shift a phase of RF-traveling waves of output RF power 17 so that energy therefrom is concentrated primarily in predetermined energy dissipation zone 5 which lies at a desired depth beneath surface 6 of biological tissue 4. The selected target is positioned within energy dissipation zone 5.
Method 100 further includes converting 106 impedance of biological tissue 4 belonging to the subject from a nominal value to a corrected value. The corrected value matches a characteristic impedance characteristic of RF energy source and RF
transmission Line including a cable 1 l and a phase shifter 14 so that output RF-traveling wave 17 may pass through surface 6 of biological tissue 4 without being converted to a standing wave by means of IMN l I;
Method 100 further includes cyclically 108 accumulating/releasing in an RF
resonator 13 located in applicator 3 the desired amount of energy.
Method 100 further includes concentrating 110 the desired amount of energy in RF resonator 13 so that a significant portion thereof is concentrated in the predetermined energy dissipation zone 5 upon release from resonator 13.
Method 100 further includes conveying I12 output 17 from RF energy source 10 through surface 6 of biological tissue 4 to predetermined energy dissipation zone S after output 17 has been processed by the phase shifter 14, the IMN I1 and resonator 13 by means of applicator 3.
Performance of 102, 104, 105, 108, 110 and 112 produce 114 a reverse thermal gradient so that surface 6 of biological tissue 4 is maintained at a lower temperature than predetermined energy dissipation zone 5, thereby obviating the need for a cooling device.
The absence of a ground electrode permits free propagation of the waves in output signal 17 in energy dissipation zone 5.
According to still further features in the described preferred embodiments the providing indicates provision 118 of output signal 17 in pulses of a predetermined duration and an amplitude with a desired frequency as detailed hereinabove.
Preferably, method 100 further includes interposing 120 a dielectric barrier 2 between applicator 3 and surface 6 of biological tissue 4. Dielectric barrier 2 prevents transmission of a conductive current. Preferably, method 100 further includes constructing applicator 3 primarily of aluminum. More preferably, dielectric barrier 2 is supplied as an alumina coating on an aluminum applicator 3.
Preferably, method I00 further includes moving 122 applicator 3 with respect to surface 6 of biological tissue 4 as a means of altering a location of energy dissipation zone 5.
Optionally, but preferably, method 100 further includes employing 124 a feeding cable XX to connect applicator 3, and resonator 11 with IMN 11.
Optionally, but preferably, method 100 further includes varying 126 the phase sluft provided by phase shifterl4.
Method 100 is optimally employed for cellulite treatment by selecting a predetermined energy dissipation including at least one cellulite body which serves as a target which is heated to a greater degree than tissue adjacent thereto. As a result, cellulite is reduced 128.
The present invention relies upon RF-heating of biological tissues via rotation of molecules of the water molecules 1 (fg.l), which are dipole structures, in an alternating electromagnetic field. In order to avoid a conductive HF-current a dielectric barrier 2 provides insulation between the applicator 3 and a biological tissue surface 6.
Preferably, applicator 3 is constructed from aluminum or an aluminum alloy covered by alumina coating with a thickness 40-50 p,m. Applicator 3 serves also to cool tissue surface 6, thereby obviating the need for a separate cooling system.
Applicator 3 can be also described as an antenna coupler that irradiates the RF-wave into deep tissue 4. The resultant dissipation of the energy load can be described as irradiative coupling of RF-energy.
The area through which applied RF energy is primarily applied 5 is determined by the contact area between tissue surface 6 and applicator 3 and by the phase of incident electromagnetic wave pulses 17. The energy diverges from surface 6 and is effectively dissipated 5 through tissue 4. The depth of RF-energy penetration depends on RF-power and area of applicator and phase shift of electromagnetic wave. By application of phase shifting device 14 it is possible to adjust a position of energy dissipation zone 5 and to coincide with a selected target (e.g. cellulite lesions).
The applied oscillating RF-field stimulates all dipole molecules (mostly water molecules 1) to rotate and vibrate with consequent heating of energy dissipation zone 5.
Zone 5 may be controlled by phase shifting device 14 between RF-generator 10 and applicator 3. Heating will be primarily in adipose tissue because it is rich in liquids but not subject to convective cooling as blood vessels are. Thus, collagen capsules will be destroyed by heating because their high thermo isolation. The pulse width modulation (PWM) control 12 of output RF- power that provide a possibility to keep a high peak RF-power with low average power level will leads to the most efficient collagen capsule destruction.
It is an advantage of the present invention that epidermal layer 6 is heated much less than subcutaneous tissue 4. An inverse thermal gradient that is provided by intensive cooling of epidermis that described by Thermage patents is achieved automatically with deep heating of tissues.
The absence of a second or ground electrode in the pictured configuration permits free propagation of 1RF waves inside tissue 4.
In order to maximize transmission of RF-energy from RF-source 10 (Figure 2) through resonant cable 7 to applicator 3, it is connected to the central point of a parallel resonator I3 including a capacitor 8 and an inductor 9 connected in parallel and characterized by very high-Q- factor for example more than 20.
The delivered oscillating RF-power (e.g. 25-300 watts) is stored in the resonator 13 therefore an active (dissipative) load of resonator 13 is only an adjacent tissue.
The active losses of resonator 13 are very low (20-50 times less than energy dissipated inside tissue 4). The intermittent discharge of capacitor 18 and the inductor 19 is coupled through applicator 3 to tissue 4.
RF-generator 10 capable of producing 200-400 Watts full power at 40.68 MHz operating frequency demonstrates an optimal performance at 50 Ohms resistive load.
Optimal performance means minimal reflected RF-power with maximum RF-forward -:--~_ power dissipated by a load. Thus, the real load that includes treated volume 5 of tissue 4 is matched as 50 Ohms load.
The used impedance matching network (IMN 11; see Fig.2) is fixed (the elements are not variable operatively); therefore operation occurs without 1RF-power amplitude changes. The control of output power is reached by PWM-control (pulse width modulation). PMW achieves modulation of output power by rectangular power pulses applied with a frequency lower than that of the 1RF wave. In order to decrease RF-power coupling it is necessary to reduce a duty cycle of PWM. PWM-controller 12 produces rectangular pulses with a modulation frequency range of 2-10 kHz. The duty cycle may be varied from 5 to 100%. The shape of RF-power pulse 17 is showed in Fig.2.
The PWM-control of output RF-power permits high peak RF-power level in heating zone 5 with lower average power. This provides effcient heating of adipose capsules with minimal impact on blood vessels and other tissues.
The reflected RF-power is 1-2 % of output power therefore 98% of output power is dissipated in the treated volume. Typically, we concentrate energy in adipose tissue therefore coupled RF-energy is dissipated by fat cells, cellulite capsules and by blood and lymphatic liquids. The energy that produces a useful job in fat cells and cellulite tissue will reach 70-80 % of total energy coupled to the volume. The rest energy is dissipated through diffusion of the heat to the surface and by convection of natural liquids of human body.
Applicator 3 is connected to parallel resonator 13. Applicator 3 and resonator are physically positioned inside of operating hand-piece 22 used for treatment procedure.
The IMN-system locates inside the main system 23. In order to avoid a mismatching phase shift between the applicator 3 and the IMN 11, the length of cable 7 is equal to the whole number (n) of wavelength of RF-energy (~,) in the cable material.
In order to reach necessary amplitude under the surface 6 of tissue 4, a phase shifting system (e.g. trombone-type system 14) is inserted between output of RF-generator IO and an input of IIVIN 11. The position of the maximum of energy dissipation can be controlled by this phase shifting system and can be placed under surface 6 of tissue 4. In order to control the depth of RF-energy penetration the length of trombone can be shortened that change a position of dissipated electromagnetic wave in the tissue or an area of the maximum of RF-voltage. Consequently, RF-energy will be dissipated most efficiently in the volume around maximum of the RF-voltage.
The phase shifter 14 can be controlled automatically, for example by motors 15.
This change of phase could be linear or periodical that provides a displacement of maximal heating zone inside the tissue or scanning of maximal heating zone position.
The practical implementation of impedance matching system 11 is illustrated by Fig.3. The RF-power delivered from RF-generator 10 through coaxial cable 16 is modulated by rectangular pulses 17. Because RF-generator 10 is matched to 50 Ohms and impedance of human tissue is close to 300 Ohms, it is necessary to convert 50 to 300 Ohms with compensation of electromagnetic reactance of tissue 4. This is achieved with impedance matching network 11. L-type simple fixed IMN consisting of RF-capacitor 18 and RF-inductor I9 (Fig.3) were applied for this purpose. Half wave cable 7 is applied for transmission of RF-energy from IMN 11 to RF applicator 3 without phase shifting that is controllable by phase shifting system. The measured impedance in the point 20 is 50 Ohms and in the point 21 is 300 Ohms. Impedance matching networks of various types may be employed without significantly altering performance of the present invention. Regardless of the exact IMN type employed, the IMN 11 can be variably and/or automatically controlled to trace an impedance changing.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modif cations and variations that fall within the spirit and broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identif cation of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.

Claims

1. ~An improved system for thermal treatment of a selected target within a subject, the system comprising:
(a) ~an RF energy source capable of producing an output RF power signal directed to an applicator contactable with a surface of a biological tissue belonging to the subject, said applicator capable of delivering a desired amount of energy to a predetermined energy dissipation zone beneath said surface of said biological tissue, the selected target positioned within said predetermined energy dissipation zone;
(b) ~a phase shifter, said phase shifter capable of shifting a phase of directed traveling waves of said output signal so that energy therefrom is concentrated primarily in said predetermined energy dissipation zone, which lies at a desired depth beneath said surface of said biological tissue;
(c) ~an impedance matching network (IMN), said IMN capable of converting the impedance of said biological tissue belonging to the subject from a nominal value to a corrected value, said corrected value matching an impedance characteristic of said RF
energy source and said phase shifter so that said output traveling wave may pass through said surface of said biological tissue without being converted to a standing wave;
(d) ~an RF resonator located in said applicator, said RF resonator capable of cyclically accumulating and releasing said desired amount of energy, said RF
resonator further capable of concentrating said desired amount of energy so that a significant portion thereof is concentrated in said predetermined energy dissipation zone; and (e) ~said applicator capable of conveying said output RF power signal from said RF
energy source through said surface of said biological tissue to said predetermined energy dissipation zone after said output has been processed by said phase shifter, said IMN and said resonator;
wherein operation of the system produces a reverse thermal gradient so that said surface of said biological tissue is maintained at a lower temperature than said predetermined energy dissipation zone without a cooling device; and wherein the absence of a ground electrode permits free propagation of said waves of said output RF power signal in said energy dissipation zone.

2. The system of claim 1, further comprising a pulse width modulation controller, said pulse width modulation controller capable of causing said RF
energy source to deliver said output signal in pulses of a predetermined duration and amplitude with a desired frequency.

3. The system of claim 1, further comprising a dielectric barrier positionable between said applicator and said surface of said biological tissue; said dielectric barrier preventing transmission of a conductive current.

4. The system of claim 1, wherein said applicator is made from at least one metal selected from the group consisting of aluminum, silver, gold, copper and alloys thereof.

5. The system of claim 3, wherein said dielectric barrier is supplied as a dielectric coating on said applicator.

6. The system of claim 5, wherein said applicator is constructed primarily of aluminum and said dielectric barrier is supplied as an alumina coating.

7. The system of claim 1, wherein said applicator is movable on said surface of said biological tissue as a means of altering a location of said energy dissipation zone.

8. The system of claim 1, further comprising a feeding cable, said feeding cable connecting said RF- applicator and said RF-resonator with said IMN.

9. The system of claim 8, wherein said feeding cable has a resonance length defined by n*.lambda./2 length, where .lambda. is a wavelength of RF-energy in the cable material and n is a whole number.

10. The system of claim 1, wherein said IMN includes a fixed structure characterized by a shape selected from the group consisting of L shaped, T
shaped and II-shaped structure.

11. The system of claim 1, wherein said IMN includes a broadband impedance transformer.

12. The system of claim 1, wherein said IMN is variable.

13. The system of claim 1, wherein said phase shifter includes a trombone type.

14. The system of claim 1, wherein said phase shifter is at least partially constructed of coaxial cable.

15. The system of claim 1, wherein a phase shift provided by said phase shifter is variable.

16. The system of claim 1, wherein coupled energy is delivered from RF-generator (amplifier).

17. The system of claim 1, wherein said energy delivered to said predetermined energy dissipation zone is coupled in continuous or pulsing mode.

18. The system of claim 1, wherein said RF-energy is characterized by a resonance frequency which matches a known natural resonance frequency of the selected target.

19. The system of claim 1, further comprising at least one additional component selected from the group consisting of a laser beam, an ultrasonic transducer, a UV light source, a plasma treatment device and a flash lamp.

20. An improved method for thermal treatment of a selected target within a subject, the method comprising:
(a) providing an output RF power signal directed to an applicator contactable with a surface of a biological tissue belonging to the subject, (b) employing a phase shifter to shift a phase of traveling waves in said output RF power signal so that energy therefrom is concentrated primarily in a predetermined energy dissipation zone which lies at a desired depth beneath said surface of said biological tissue, wherein the selected target is positioned within said predetermined energy dissipation zone;
(c) converting the impedance of said biological tissue belonging to the subject from a nominal value to a corrected value, said corrected value matching an impedance characteristic of said RF-source and phase shifter so that said output signal may pass through said surface of said biological tissue without being converted to a standing wave by means of an impedance matching network (IMN);
(d) cyclically accumulating in an RF resonator located in said applicator, and releasing therefrom, said desired amount of energy, (e) concentrating said desired amount of energy in said RF resonator so that a significant portion thereof is concentrated in said predetermined energy dissipation zone upon release therefrom; and (f) conveying said output signal of RF energy through said surface of said biological tissue to said predetermined energy dissipation zone after said output has been processed by said phase shifter, said IMN and said resonator by means of said applicator;
wherein performance of (a)-(f) produce a reverse thermal gradient so that said surface of said biological tissue is maintained at a lower temperature than said predetermined energy dissipation zone, thereby obviating the need for a cooling device;
and wherein the absence of a ground electrode permits free propagation of said waves in said output signal in said energy dissipation zone.

21. The method of claim 20, wherein said providing indicates provision of said output signal in pulses of a predetermined duration and amplitude with a desired frequency

22. The method of claim 20, further comprising interposing a dielectric barrier between said applicator and said surface of said biological tissue; said dielectric barrier preventing transmission of a conductive current.

23. The method of claim 20, further comprising constructing said applicator from at least one metal selected from the group consisting of aluminum, silver, gold, copper and alloys thereof.

24. The method of claim 22, wherein said dielectric barrier is supplied as a dielectric coating on said applicator.

25. The method of claim 24, further comprising constructing said applicator primarily of aluminum and said dielectric barrier is supplied as an alumina coating

26. The method of claim 20, further comprising moving said applicator with respect to said surface of said biological tissue as a means of altering a location of said energy dissipation zone.

27. The method of claim 20, further comprising employing a feeding cable to connect said RF- applicator and said RF-resonator with said IMN.

28. The method of claim 27, wherein said feeding cable has a resonance length defined by n*.lambda./2 length, where .lambda. is a wavelength of RF-energy in the cable material and n is whole number

29. The method of claim 20, wherein said IMN includes a fixed structure characterized by a shape selected from the group consisting of L shaped, T
shaped and .pi.
shaped structure.

30. The method of claim 20, wherein said IMN includes a broadband impedance transformer.

31. The method of claim 20, wherein said IMN is variable.

32. The method of claim 20, wherein said phase shifter includes a trombone type.

33. The method of claim 20, wherein said phase shifter is at least partially constructed of coaxial cable.

34. The method of claim 20, wherein a phase shift provided by said phase shifter is not constant.

35. The method of claim 20, said providing an output signal of RF energy indicates coupled energy.

36. The method of claim 20, wherein said energy delivered to said predetermined energy dissipation zone is coupled in continuous or pulsing mode.

37. The method of claim 20, wherein said desired amount of energy released by said RF resonator is characterized by a resonance frequency that matches a known resonance frequency of the selected target.

38. The method of claim 20, further comprising at least one additional component selected from the group consisting of a laser beam, an ultrasonic transducer, a UV light source, a plasma treatment device and a flash lamp.

39. The method of claim 20, wherein (a) through (f) are performed in the order listed.

40. An improved method for cellulite treatment, the method comprising:
(a) providing an output signal of RF energy directable to an applicator contactable with a surface of a biological tissue belonging to the subject, (b) employing a phase shifter to shift a phase of waves in said output traveling wave so that energy therefrom is concentrated primarily in a predetermined energy dissipation zone which lies at a desired depth beneath said surface of said biological tissue, wherein the selected target is positioned within said predetermined energy dissipation zone, said predetermined energy dissipation zone including at least one cellulite body;
(c) converting the impedance of said biological tissue belonging to the subject from a nominal value to a corrected value, said corrected value matching an impedance characteristic of said RF-power source and said phase shifter so that said output signal may pass through said surface of said biological tissue without being converted to a standing wave by means of an impedance matching network (IMN);
(d) cyclically accumulating in an RF resonator located in said applicator, and releasing therefrom, said desired amount of energy, (e) concentrating said desired amount of energy in said RF resonator so that a significant portion thereof is concentrated in said predetermined energy dissipation zone upon release therefrom; and (f) conveying said output from said RF energy source through said surface of said biological tissue to said predetermined energy dissipation zone after said output has been processed by said phase shifter, said IMN and said resonator by means of said applicator;
wherein performance of (a)-(f) produce a reverse thermal gradient so that said surface of said biological tissue is maintained at a lower temperature than said predetermined energy dissipation zone, thereby obviating the need for a cooling device;
and wherein the absence of a ground electrode permits free propagation of said waves in said output signal in said energy dissipation zone; and wherein said at least one cellulite body is heated to a greater degree than a tissue adjacent thereto.