WO2018127921A1

WO2018127921A1 - Apparatus and method for skin rejuvenation

Info

Publication number: WO2018127921A1
Application number: PCT/IL2018/050019
Authority: WO
Inventors: Genady Nahshon; Lion Flyash
Original assignee: Brighttonix Medical Ltd.
Priority date: 2017-01-09
Filing date: 2018-01-07
Publication date: 2018-07-12

Abstract

Apparatus and method for facial skin tissue rejuvenation are provided. The apparatus comprises a mouth-piece applicator inserted into the mouth for applying RF energy to a portion of oral mucosa located opposite a facial skin tissue portion, the applicator comprising a housing comprising a treatment surface for positioning in the vicinity of the portion of oral mucosa; and an electrode assembly mounted on the treatment surface such that the electrode assembly faces the portion of oral mucosa, the electrode assembly delivers RF current of a predetermined profile to the portion of oral mucosa, thereby heating deep tissue layers under the portion of oral mucosa to a predetermined temperature profile; and a power source and control unit configured to generate at least one activation signal having a predetermined time-frequency profile to controllably operate the electrode assembly to create said predetermined profile of RF current and generate said predetermined temperature profile.

Description

APPARATUS AND METHOD FOR SKIN REJUVENATION

TECHNOLOGICAL FIELD

The present invention is generally in the field of aesthetic and cosmetic devices and methods, and relates specifically to tissue rejuvenation, and more specifically to facial skin rejuvenation. BACKGROUND

Facial rejuvenation is a cosmetic treatment aimed at restoring a youthful appearance to the human face. Facial rejuvenation can be achieved through either invasive and/or non-invasive procedures.

Invasive procedures can restore facial symmetry through surgical interventions, such as facial restructuring and skin alterations. The surgical procedures include, for example, a brow lift (forehead lift), eye lift (blepharoplasty), facelift (rhytidectomy), chin lift and neck lift.

Non-invasive procedures can target and treat specific or localized facial structures, such as wrinkles, skin laxity, hyperpigmentation and scars. The non-invasive treatments include, for example, chemical peels, neuromodulator (e.g., botulinum toxin

(Botox)), dermal fillers (e.g., collagen), laser resurfacing, photo-rejuvenation, radiofrequency and ultrasound.

WO04011086 describes a method for rejuvenating face neck and body skin. The method includes simultaneously exposing a skin to the action of electric current and electromagnetic radiation (red laser and/or infrared laser radiation) . the method makes it possible to use ozone for photobiological activation of tissue and cell metabolism.

WO 16066051 describes a 3D integrated facial beauty instrument, comprising a mask and a circuit board provided in the mask, wherein several RF metal bump means electrically connected to the circuit board are provided in the mask for performing radio frequency nursing with a deep transparent effect on the face, and can solve facial problems such as skin rejuvenation, and can be used against wrinkles, for acne treatment, whitening, and removing blemishes at the same time. WO2014150090 describes a device directed to treatment of a migraine headache or other nervous system malady such as seizures and epilepsy by applying electrical stimulation to a subject's oral mucosa. Noninvasive electrodes may be placed against the subject's oral mucosa tissue by inserting a mouthpiece comprising the electrodes into the subject's mouth. One or more electrical pulses may be applied to the electrodes to stimulate the subjects cranial nerves and thereby treat the malady.

GENERAL DESCRIPTION

The present invention provides novel apparatus and method for non-invasively and safely rejuvenating and tightening facial skin with remarkable and effective results. The invention enables easy, safe and accessible facial rejuvenation for home as well as professional use. The technique of the invention utilizes application of Radio-Frequency (RF) energy/current to internal side (from intraoral cavity) of the face, inter alia to oral mucosa. In contrast, current techniques apply RF energy to the outer facial skin tissue which is occasionally accompanied with side effects, such as burns and varied, non- homogeneous, skin look and color.

According to the invention, the application of the RF current/energy is aimed at heating the internal side of the facial tissue, i.e. the deep layers of the skin tissue, in order to stimulate a healing process that causes tightening of the facial outer skin. The heating of surface and deep intraoral tissue according to a predetermined temperature profile, caused by a defined RF energy application, induces tissue remodeling and stimulates sub- dermal collagen and and/or elastin production which in turn reduces the appearance of fine lines and loose skin on the outer facial tissue.

According to the invention, the skin rejuvenation can be further enhanced by simultaneous application of the RF energy together with a specific formulation to the internal facial tissue. The formulation can be selected from a group of formulations known for their collagen building effects and contribution to the tightening of the skin. For example, the formulation is Hyaluronic Acid.

The present invention provides flexible, selective and controllable application of the rejuvenation procedure, i.e. control over precise location of the treatment and/or control over the treatment parameter(s)/condition(s) of the specific facial tissue portion. The present invention provides a flexible tissue tightening device which enables selective application of a treatment mode having defined conditions/parameters to a specific facial tissue site. For example, applying a single mode treatment session of defined parameters (e.g., temperature, duration) to the facial tissue. On the other side, different facial regions, such as cheeks, lips and chin, can be subjected to different profiles of the applied RF energy, e.g. by differentiating the magnitude and/or duration and/or time pattern of the applied RF energy to specific simultaneously treated facial regions. For instance, there might be a need to apply multiple intensities to different adjacent facial tissue portions. Accordingly, the present invention provides a flexible tissue tightening device which enables selective application of a plurality (at least two) of treatment modes of different conditions/parameters to different facial tissue sites at the same time or during the same treatment session, thus providing fast and effective treatment.

The application of the RF energy and the formulation, when used, is carried out by a dedicated mouth-piece applicator configured to be positioned in the oral cavity and contact the internal side, the oral mucosa, of the facial tissue. The applicator carries thereon electrode(s) and a chamber for receiving the formulation, such that the formulation is located between the electrode(s) and the intraoral tissue.

The RF energy can be applied in mono or bi-polar mode. The electrode(s) is/are located on the applicator, either fully or partially exposed on the outer side thereof. In one example, two electrodes working in bi-polar mode are located with a predetermined distance one above the other on the mouth-piece applicator, such that a current flows therebetween through the facial tissue and the formulation, if used.

It should be noted that for the purposes of the present invention, the term "RF energy" should be interpreted broadly covering at least "electric field", "magnetic field", or "electromagnetic field" utilizing both electric and magnetic energies. Such RF energy may be applied by an alternating current (AC) signal.

According to the invention, the application of RF energy, during a treatment session, can have certain time and frequency pattern (i.e. being a function of time and/or frequency), the application can be continuous or pulsatile.

It should further be noted that alternating field (electric or magnetic or electromagnetic), as used for the purposes of the present application, refers to a field that reverses its polarity at regularly or irregularly recurring intervals of time, and which thus has alternatively positive and negative values. The shape / profile of the alternating field/current could be of a sinusoidal, rectangular, triangular, saw tooth or any other shape.

Thus according to a first broad aspect of the present invention, there is provided an apparatus for facial skin tissue rejuvenation, comprising: a mouth-piece applicator configured to be inserted into the mouth for applying RF energy to at least a portion of oral mucosa located opposite a facial skin tissue portion undergoing rejuvenation treatment, the applicator comprising: a housing comprising a treatment surface configured to be positioned in the vicinity of the portion of oral mucosa; an electrode assembly mounted on the treatment surface such that the electrode assembly faces the portion of the oral mucosa, the electrode assembly being configured to deliver RF current of a predetermined profile to the portion of oral mucosa, thereby heating deep tissue layers under the portion of oral mucosa to a predetermined temperature profile; and a power source and control unit being in signal communication with said electrode assembly and configured to generate at least one activation signal having a predetermined time-frequency profile to controllably operate the electrode assembly to create said predetermined profile of RF current and generate said predetermined temperature profile, thereby stimulating collagen formation and tightening of said facial skin tissue portion.

The housing may further comprise a chamber aligned with said electrode assembly and configured to receive therein a formulation, such that the formulation is located in the vicinity of both said electrode assembly and said portion of oral mucosa.

In some embodiments, said housing has a U-like shape having U arms configured to surround the subject's teeth and push against right and left sides of the oral mucosa. In some embodiments, said housing has a dental tray-like shape being configured to be placed on the subject's arcade, said treatment surface being on outer side of the dental tray such that the treatment surface faces the oral mucosa.

The electrode assembly may comprise at least one electrode aligned with said portion of oral mucosa, said at least one electrode being operated in a monopolar activation mode. In some embodiments, the electrode assembly comprises at least one pair of electrodes located one above the other with a predetermined distance therebetween, said at least one pair of electrodes being operated in a bi-polar activation mode. In some embodiments, the electrode assembly comprises an array of spaced-apart electrodes configured and operable to be individually or collectively operated in mono- and/or bi-polar activation mode to deliver a plurality of RF currents to a respective plurality of oral mucosa tissue portions.

The power source and control unit may comprise at least one of the following: a power inlet for connecting to a DC outlet, a power inlet for connecting to an AC outlet, a rechargeable battery, a single-use battery, a mobile phone, a tablet computer, a laptop computer, and a DC to AC converter. In some embodiments, the power source and control unit further comprises a memory unit, the memory unit being configured to store at least one of the following: i) at least one treatment parameter, and ii) at least one physical parameter. The power source and control unit may be configured to control said at least one treatment parameter or said at least one physical parameter. The treatment parameter may comprise at least one of the following: treatment time, magnitude of the RF current, type of AC waveform, AC frequency, temperature of the oral cavity, temperature of the deep tissue layers, magnitude of the voltage and duty cycle of the RF current. The physical parameter may be related to at least one of the following: the formulation, the applicator, at least one electrode, the oral mucosa portion or a tissue in the vicinity of the oral mucosa portion, tissue reflectivity, tissue impedance, applicator temperature, electrode assembly temperature, formulation temperature, formulation impedance, current, and voltage.

The apparatus may comprise at least one sensor comprising at least one of the following: a thermistor, an optical sensor, an ammeter, an impedance meter, and a voltage meter. The control unit may be configured to store at least one measurement by said at least one sensor.

The apparatus may comprise feedback control for said at least one treatment parameter, wherein said feedback control operates in method comprising steps of: (i) measuring a physical parameter and (ii) altering at least one said treatment parameter based on said measurement of said physical parameter.

According to another broad aspect of the present invention, there is provided a method of facial tissue rejuvenation treatment, the method comprises applying RF current of a predetermined profile to at least a portion of oral mucosa located opposite a facial skin tissue portion undergoing the facial tissue rejuvenation treatment; and maintaining said application of the RF current until a predetermined temperature profile is achieved in deep tissue layers under said portion of oral mucosa; thereby stimulating collagen formation in said deep tissue layers and tightening of said facial skin tissue portion.

The method may further comprise simultaneously applying to said portion of oral mucosa, with said RF current, a formulation known for its collagen building stimulating effect. The formulation may include Hyaluronic Acid.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to better understand the subject matter that is disclosed herein and to exemplify how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:

Fig. 1 is a schematic illustration of structural characteristics of an apparatus of the present invention;

Figs. 2A-2C schematically illustrate examples of mouth-piece applicator embodiments of the present invention for facial skin rejuvenation;

Fig. 3 is an example of a power source and control unit for use with the mouthpiece applicator; and

Figs. 4A-4D depict AC waveforms that may be used for generation of the RF current. DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to Fig. 1 showing a schematic block diagram of An apparatus 10 (medical or cosmetic) configured in accordance with the present invention. As shown in the figure, the apparatus 10 includes an applicator 100, and an electromagnetic (RF) power source and control device 400. The applicator 100 and the power source and control device 400 are configured for connection between them, generally designated 200, which may refer to a direct electric connector 200 or a signal transmission 200. As shown in the figure by the dashed line 30, the power source and control device 400 may be integrated with the applicator 100, being a constructional part of the applicator 100, and being operable either using a battery or connection to a power network. As also shown in the figure as an alternative option, the power source and control device 400 may be placed in a separate package/enclosure 20. In yet another example, the elements of the power source and control device 400 may be distributed between the applicator unit 100 and separate package/enclosure 20. The applicator 100 includes an electrode assembly 120, configured to be in electric communication with the power source and control unit 400, via the connection 200. The electrode assembly 120, when operated (supplied with electrical signal), creates one or more of RF current/energy regions (generally at 101) in the treated facial internal tissue. The power source and control unit 400 includes a control unit 444, and a power generator 430 which is connected to and activated by the control unit 444 via a connection circuit 452, which may be a wired or wireless connection. As shown in the figure, the power generator 430 and the control unit 444 may be joined together in a common package/enclosure 20, or may be placed in two separate packages/enclosures 22 and 24. In some embodiments (not specifically shown), one of the power generator 430 and the control unit 444 may be integrated with the applicator 100, while the other of them is left in its separate package. It might be more practical that the power generator 430 is integral with the electric applicator, while the control unit 444 is a separate unit which controllably modifies the electric signal generated by the power generator 430 by a predetermined activation function and possibly its settings are updated for a specific individual (via user interface) 450. In some embodiments, the power generator 430 is integral with the applicator 100 and is controlled by specially designed application for personal electronic devices, such as smartphones and tablets. To this end, the control unit 444 is at least partially embedded in such personal electronic device. In some embodiments, a feedback control system 454 may be incorporated in the control unit 444 and used to determine at least one of the parameters of a treatment as a function of time or position. In such embodiments, at least one sensor 456 is located in the mouthpiece applicator 100 and configured to measure a parameter related to the tissue under treatment, such as the oral mucosa, or different parameters of the RF energy. The parameter may also relate to the formulation, the applicator, or at least one electrode in the electrode assembly. The parameter can be related to tissue characteristics such as temperature, conductivity, reflectivity, impedance and any combination thereof. The feedback control may be based on at least one of the following: the measurement, the change in measurement as a function of time, the difference between a measurement for one tissue portion and the measurement for another tissue portion, the difference between change in measurement for one tissue portion and the change in measurement for another tissue portion and any combination thereof. The control unit 444 alters the at least one parameter of the treatment in order to accomplish the desired rejuvenation treatment. As a non-limiting example, if the sensor 456 determines that a desired tissue heating effect has been achieved for a tissue portion, the control unit 444 can discontinue treatment for that tissue portion, while continuing treatment to other tissue portion(s) which have not yet arrived at the desired heating/temperature effect. Similarly, if a tissue portion is heating more slowly than desired, or more slowly than other tissue portion(s), then the treatment parameters can be adjusted for that tissue portion, for example by increasing the RF current intensity or duration to that tissue portion.

The power source and control unit 400 is responsible for generating the RF signals which are then transmitted (via the operation of the control unit to provide a desired profile of said signals) to the electrode assembly 120 in the applicator 100.

As briefly described above, the power source and control unit 400 includes the power generator 430 which physically generates the RF signals modified by the activation function produced by the control unit 444. To this end, the control unit 444 is typically a computerized system being hardware and/or software based system, and includes at least such as modules as a field profiling module 446, a duration controlling module 448 for controlling duration of a treatment session, and a user interface module 450. In some embodiments, the control unit 444 also includes a formulation/gel/substance controller 451, configured for measuring or monitoring one or more parameters of the formulation/substance (material status), which may be indicative of the treatment process, such as for example measurement of impedance of the formulation/substance. The substance controller is actually associated with a measurement / sensing circuit (electric, optical, electro-optical, etc.), which is typically integral with the applicator 100 and connectable (via wires or wireless) to the formulation controller 451. Also, as shown in the figure, the control unit may also include a process controller 453 for controlling various parameters and conditions of the rejuvenation treatment process, such as one of the following: control the amount and location of the formulation. As will be described further below, the power source and control unit 400 may include one or more indicators which is/are associated with one or more sensor(s) and controller(s) to provide indication and alert the user if the treatment process deviates from the treatment plan / program.

The field profiling module 446 generates a control function (shown at 201) which is a time and frequency function and controls the profile / shape (the frequency and amplitude over time) of the electric/magnetic RF field/signals to form a desired RF activation function 202. The control function (shown at 201) may be applied to the output of the power generator 430 (or may be fed into the power generator) in order to properly modify the electric/magnetic RF field activating signal. The power generator can be supplied with a power inlet for connecting to a direct current (DC) outlet or a power inlet for connecting to an AC outlet. It should be understood that in case the power generator is configured to be directly connected to a DC power network, the power generator or the control unit (as the case may be) can include an AC-DC converter and/or a DC-AC converter (as well as A-to-D converter). If the power generator includes a battery, then either the power generator or the control unit includes an appropriate DC-AC converter. Generally, the parameters of the control function and accordingly of the activation function (shape, frequency and amplitude) may be of any suitable shape or magnitude. For example, the shape of the activation function may be one or a combination of sinusoidal, rectangular, triangular, saw tooth or any other suitable shape. Preferably, the frequency of the RF electrical signal is relatively high, e.g. of a few hundreds of kHz and up to the range of tens of MHz, as will be detailed further below. The amplitude may be in the range from 3Vrms up to 800Vrms. The activation function may also be a combination of different activation sub-functions (via multiplexing or any other combining method known in the art). In other words, the treatment protocol may include application of a generated RF signal which has a single shape and a single frequency for the whole duration of activation, or it may have a consequence of shapes and frequencies. It is also noted that the treatment session may include several activation functions applied to several electrodes in order to activate several localized treatment protocols to selected tissue portions in the region being treated.

The control unit 444 also controls the duration of the treatment session via the module 448, and possibly also a time pattern of multiple treatment sessions, which may be similar or different in the duration times and/or activation functions produced by the module 446.

Finally, the user interface 450 of the control unit 444 enables the user to control the whole treatment session, by defining each of the parameters of the activation function and its duration. The applicator 100 includes a treatment surface 102 and a formulation/substance chamber 106. The treatment surface/interface 102 is configured to be placed on the intraoral tissue undergoing treatment. The electrode assembly is mounted on the treatment surface/interface 102 and preferably touches the tissue. The formulation/substance used with the treatment procedure (such as Hyaluronic Acid) is placed in the chamber 106 such that the formulation is located between the treatment surface 102, including the electrode assembly 120, and the treated tissue. The treatment surface 102 can include one continuous treatment site or a plurality of spaced-apart treatment sites 104 defined and configured to contact the formulation, such that the treatment site(s) define respective electrode-formulation-tissue contact region(s) located inside the RF energy region 101 thereby defining treatment zone(s) where treatment is applied, in the case, more than one treatment site exists, the applicator 100 may include one chamber 106 being in contact with the plurality of treatment sites, or a corresponding plurality of respective chamber(s) 106.

The formulation chamber(s) 106 is/are configured as compartment(s) configured to receive the formulation (substance, gel) therein. In some embodiments, the applicator 100 is configured to hold the formulation embedded in a specially designed grooves or pockets which are configured to controllably release the formulation into the chamber(s) to be in contact with the electrode assembly 120 and the tissue when required.

The electrode assembly 120 of the applicator 100 may include at least one electrode working in a monopolar mode (such that the subject's body may serve as the counter electrode), or may include at least one pair of electrodes working for example in bipolar mode. As will be described further below, the electrode assembly can include a plurality of electrodes (an array of electrodes, a matrix of fractionated electrodes) configured to create a plurality (one- two- or three-dimensional array) of RF current regions defining the different treatment sites 104. In the latter case, the parameters/conditions in the multiple RF current regions are preferably separately controlled/operated by separately operating and controlling each or a group of electrodes in the electrode array. Such electrode assembly, when operated, creates multiple RF regions associated with respective multiple treatment sites. It should be understood that, the electrode assembly 120 may include a single electrode configured to apply RF energy in the treatment zone, via one or more treatment sites 104. Alternatively, the electrode assembly may include a plurality of electrodes, such that each electrode is configured to apply the RF energy to one or more treatment sites 104. As describes above in one specific embodiment, the number of electrodes may be equal to (or twice of, in the case of bipolar activation mode) the number of treatment sites 104, such that each treatment site is operated by a single electrode (or a pair of electrodes).

The electrode(s) of the electrode assembly is/are preferably made of a biocompatible conductive material such as, but not limited to, stainless steel, titanium, gold and any combination thereof.

In embodiments with more than one electrode, the electrodes are preferably individually controllable via the control unit 444. As a non-limiting example, between any two electrodes, the electrodes can have either same or different currents, voltages, waveforms, frequencies, duty cycles, treatment times, and any combination thereof.

Thus, the apparatus 10 of the present invention provides full control over all the parameters needed to execute a successful and effective tissue rejuvenation treatment. The full or partial control of the treatment process parameters (including also a treatment session duration, number of treatment sessions, the time pattern of the multiple treatment sessions, etc.) may be setup in the control unit 444 prior to supplying the apparatus, or only the control unit, to the user, and/or may give the user access for updating / adjusting the parameter(s). The apparatus 10 may be supplied in a specific kit for use in tissue rejuvenation treatment (professional or home use). The kit includes a set of one or more applicators, one or more power source and control units, and one or more formulation (such as Hyaluronic Acid) packages.

Reference is made to Figs. 2A-2C showing schematically different examples of the mouth-piece applicator for applying RF energy to the intraoral facial tissue, i.e. the oral mucosa, in accordance with the present invention, it should be understood that the presented applicators are examples only and they do not limit the invention. It should also be noted that, the combinations of features, such as the applicator housing, electrode assembly and formulation chamber, are not limited to the specific examples, and it is possible to mix and match between the different embodiments. For example, it possible to use each of the described housings with each of the described electrode assemblies.

In Fig. 2A, the mouth-piece applicator 100A includes a housing 110A including the treatment surface 102A, an electrode assembly 120A and a formulation chamber 106A. The housing 110A is configured to be positioned inside the subject's mouth such that it contacts or attaches to the internal facial tissue undergoing treatment. Generally, the housing 110A is configured to be inserted into the subject's mouth such that it surrounds the teeth on their outer side, by its internal side llOi, and is pushed against the internal side of the face (the oral mucosa), by its external side llOe which is the treatment surface.

In one embodiment, as shown in the figure, the housing 110A has a U-like shape, such that the bottom side of the U-like shape surrounds the frontal teeth when the applicator is located inside the mouth. In some embodiments, the housing is configured as a two U-like upper and lower portions configured to surround the upper and lower teeth arcades and to contact the upper and lower parts of the facial internal tissue respectively. In yet some other embodiments, the housing may be configured as a right or left half U- like shape configured to be applied to one side of the face. In other words, the housing shape can be custom-made to fit the shape of the specific facial internal tissue portion to which the RF energy is going to be applied. Additionally or alternatively, the control over the tissue portion undergoing treatment can be achieved through the activation of a specific part of the electrode assembly as will be detailed below, while using a unified U- like housing.

The housing 110A is made from a biocompatible, nonconductive material, such as , but not limited to, silicon , a foam material, nylon, or PVC; and any combination thereof. The housing is configured to attach or conform to the treated tissue by pushing against the internal facial tissue, either by adjusting its size such that it fits tightly, yet comfortably, between the teeth and the facial internal tissue, or by providing it with a structure that pushes the U arms outwardly such that they attach and stick to the facial internal tissue even if they do not come in contact with the teeth. The latter can be achieved by a spring in compression located between the U arms which naturally causes the U arms to move outwardly via the spring' s relaxation. The spring' s stiffness is defined in view of the desired pushing force applied against the facial internal tissue.

In this example, the electrode assembly includes a single electrode 120A extending along the perimeter/envelope of the housing 110A, to thereby enable treating the whole facial tissue; therefore, a single, monopolar, treatment is applied to the whole treated tissue each time. The electrode assembly is mounted on the external side llOe , being fully exposed, such that it contacts the oral mucosa, when the applicator is inserted in the subject's mouth.

The formulation chamber 106A is in the form of a groove located on the external side llOe and extends along the perimeter of the U-like housing 110A, substantially parallel to the electrode assembly, for receiving the formulation and enabling the electrode-formulation-tissue contact and defining the treatment zone.

In Fig. 2B, other possible variations of the electrode assembly and the applicator housing are shown. Again, it is noted that all the presented variations can be mixed and matched. In other words, the configuration of the housing can be used with the single electrode 120A described above in Fig. 2A. As shown, the applicator 100B has a housing HOB of a U-like shape, similar to the applicator 100A, however, the electrode assembly 120B is partially exposed on the outer side of the housing HOB, such that the housing has openings or channels 112B along its perimeter configured to insert the electrode assembly 120B therethrough. This is particularly helpful when building the housing from a flexible material, such as silicon, because this helps in fixating the electrode assembly on the housing.

The electrode assembly 120B includes two electrodes 120B1 and 120B2, arranged one above the other, with a predefined distance therebetween. This configuration enables at least two different activation modes depending on how they are connected to the power source and control unit 400. The first activation mode is by activating the two electrodes in bi-polar mode, such that the RF current flows from one electrode through the facial tissue and the formulation (if used) to the second electrode. This enables a single treatment to the whole contacted tissue each time. The second activation mode is by activating each of the two electrodes separately in monopolar mode, and in this case two separate treatments can be applied to two different tissue portions (practically, the upper part of the face and the lower part of the face), or if needed the treatment is applied only to one tissue portion by activating only one of the electrodes.

The formulation chamber 106B includes two chambers 106B1 and 106B2, each aligned with one of the two electrodes to enable maximum activation flexibility, e.g. when activating only one electrode, there is no need to use the chamber aligned with the second electrode.

In Fig. 2C, the applicator lOOC has a housing HOC having a dental tray form, such as those used by dentists to take samples of the teeth arcades. This structure can enable easy installation of the applicator inside the mouth and secure fit and positioning.

The electrode assembly 120C includes an mxn array of point fractionated electrodes 120C configured to apply localized RF energy in the vicinity of each electrode, therefore allowing greater control over the treated tissue portions with respect to the location and the localized treatment profiles. As appreciated, some or all the electrodes in the array can be activated in monopolar mode(s), some or all the electrodes can be activated as pairs in bi-polar mode(s), some can be activated in monopolar mode(s) while the rest are activated as pairs in bi-polar mode(s). The activation modes, mono- as well as bi-polar, can be identical or different across the whole electrode assembly.

Preferably, the formulation chamber 104C includes, in this case (though not specifically shown), a plurality of localized chambers aligned with the electrodes in the electrode assembly. It is not necessary, and it might not be practical, that the ratio between the chambers and the electrodes is 1: 1, however, a ratio as close as possible to 1 : 1 enables greater control over the treatment to different tissue portions.

In each of the exemplified applicators, the applicator can also comprise a thermistor which monitors the temperature during the heating process. The thermistor can be embedded in the applicator, attached to the surface of the applicator, or can stand proud of the applicator. In preferred embodiments, the temperature in the oral cavity can be kept in a range between about 39 degrees C and about 48 degrees C. It should be noted that the term 'about' used herein typically refers to a range of plus or minus 25% around the nominal value.

In some embodiments, the applicator comprises sensors, such as, but not limited to a thermistor, an ammeter, a voltage meter, an optical sensor and any combination thereof.

The applicator can be rigid or flexible. Preferably, it is sufficiently stiff such that the formulation can be placed in the chamber without significant deformation of the applicator and such that, during use, deformation of the applicator is sufficiently small that the formulation substantially remains therein.

Reference is made to Fig. 3 showing a schematic illustration of an example of the apparatus 10 of the present invention. As shown in the figure, a power source and control unit 400A located in a separate enclosure 20A, and the applicator 100A are connected together with the help of a wired connection 200A. It should be noted that a wireless connection may be established instead of the wired connection. A control unit 444A (hardware/software), installed in the power source and control unit 400A, includes a user interface 450A including external controls 500A which enable a user to set treatment parameters including, but not limited to, treatment time, magnitude of the current, type of AC waveform, maximum and minimum temperatures in the mouth cavity during treatment, maximum and minimum temperatures in the treated tissue during treatment, magnitude of the voltage, AC frequency, and any combination thereof. The control unit can also include one or more display means 600A to display parameters such as, but not limited to, time left in a treatment, time elapsed since the start of the treatment, temperature in the oral cavity, magnitude of the current, magnitude of the voltage, selected waveform, measured waveform, and any combination thereof. The display 600A can be, for non-limiting example, a screen showing text and/or graphics, lights of different colors or in different positions, a bell, buzzer or other producer of sound, and any combination thereof. As a non-limiting example, the screen or a button could show one color if the treatment is proceeding normally, a second color if the temperature in the oral cavity or oral mucosa is too low, a third color if the temperature is approaching the upper limit, and a fourth color if the temperature is too high.

The control unit may also generate audible warnings sounds, e.g. when a treatment is completed, or when a predetermined amount of time is left before completion of a treatment (e.g., a warning one minute before a treatment is completed). In some embodiments, an audible warning is sounded after a predetermined period of time elapses during a treatment (e.g., a beep once a minute during a ten-minute treatment). Any combination of warnings can be made. Warnings can be the same, or they can be different.

If the RF current used is AC current, the frequency of the current can be defined by the control unit in the range from about 300.0 KHz to about 40.0MHz. Typically, it is in a range either from about 1.0 MHz to about 10.0 MHz or from about 1.0MHz to about 8.0MHz. The RMS amplitude of the current can be in the range from about 0.005 amp to about 1.0 amp. The RMS power can be in the range from about 0.005W to about 50.0W.

During treatment, the current and voltage can be applied continuously or they can be pulsed. In a pulsed application, alternately, AC current and voltage are applied for a time substantially longer than the time for one waveform, and no current or voltage is applied for a time substantially longer than the time for one waveform. As a non-limiting example, a pulsed treatment could comprise a treatment time of 10 min, with the AC current being on for 2 s and off for 4 s, for a total of 100 pulses during the treatment. The duty cycle of a pulsed application, the ratio of the fraction of the time that current is applied to the fraction of the time that no current is applied, can be between 0 and 100%. A 100% duty cycle is, of course, continuous treatment. In some embodiments, the control unit has separate controls for setting treatment time and activating the treatment current. In other embodiments, setting the treatment time to a non-zero value starts the treatment current.

In some embodiments, the apparatus is configured to control the amount and location of the formulation within the formulation chamber and alerts the user if the amount of the formulation is not sufficient.

In some embodiments, the apparatus, e.g. the control unit 444, can include a memory for building a database and storing physical parameters of the formulation such as, but not limited to impedance, density, heat capacity, current through the compound for a predetermined voltage, and any combination thereof and preferred or optimal treatment parameters such as, but not limited to, treatment time, treatment temperature, treatment temperature change, duty cycle, waveform, AC frequency and any combination thereof.

Reference is made to Figs. 4A-4D, showing examples of the waveform shape. For example, the waveform can be a sine wave (Fig. 4A), a square wave (Fig. 4B), a triangular wave (Fig. 4C), a saw-tooth wave (Fig. 4D), and any combination thereof.

A non-limiting example of a treatment using the apparatus of the invention includes the following steps: (a) setting the parameters of a treatment; (b) optionally, filling an applicator with a formulation; (c) placing the applicator in the mouth; (d) closing the mouth so as to retain the applicator stably in position; (e) starting the treatment by activating the power generator source (f) waiting until the treatment is complete, e.g. by achieving a predetermined required temperature in the deep layers of the facial tissue; and (g) removing the applicator from the mouth.

Claims

CLAIMS:

1. An apparatus for facial skin tissue rejuvenation, comprising:

a mouth-piece applicator configured to be inserted into the mouth for applying RF energy to at least a portion of oral mucosa located opposite a facial skin tissue portion undergoing rejuvenation treatment, the applicator comprising: a housing comprising a treatment surface configured to be positioned in the vicinity of the portion of oral mucosa; an electrode assembly mounted on the treatment surface such that the electrode assembly faces the portion of the oral mucosa, the electrode assembly being configured to deliver RF current of a predetermined profile to the portion of oral mucosa, thereby heating deep tissue layers under the portion of oral mucosa to a predetermined temperature profile; and a power source and control unit being in signal communication with said electrode assembly and configured to generate at least one activation signal having a predetermined time-frequency profile to controllably operate the electrode assembly to create said predetermined profile of RF current and generate said predetermined temperature profile, thereby stimulating collagen formation and tightening of said facial skin tissue portion.

2. The apparatus of claim 1, wherein said housing further comprises a chamber aligned with said electrode assembly and configured to receive therein a formulation, such that the formulation is located in the vicinity of both said electrode assembly and said portion of oral mucosa.

3. The apparatus of claim 1 or 2, wherein said housing has a U-like shape having U arms configured to surround the subject's teeth and push against right and left sides of the oral mucosa.

4. The apparatus of any one of the preceding claims, wherein said housing has a dental tray-like shape being configured to be placed on the subject's arcade, said treatment surface being on outer side of the dental tray such that the treatment surface faces the oral mucosa.

5. The apparatus of any one of the preceding claims, wherein said electrode assembly comprises at least one electrode aligned with said portion of oral mucosa, said at least one electrode being operated in a monopolar activation mode.

6. The apparatus of any one of claims 1 to 4, wherein said electrode assembly comprises at least one pair of electrodes located one above the other with a predetermined distance therebetween, said at least one pair of electrodes being operated in a bi-polar activation mode.

7. The apparatus of any one of claims 1 to 4, wherein said electrode assembly comprises an array of spaced-apart electrodes configured and operable to be individually or collectively operated in mono- and/or bi-polar activation mode to deliver a plurality of RF currents to a respective plurality of oral mucosa tissue portions.

5 8. The apparatus of any one of the preceding claims, wherein said activation signal is an AC signal.

9. The apparatus of any one of the preceding claims, wherein said power source and control unit comprises at least one of the following: a power inlet for connecting to a DC outlet, a power inlet for connecting to an AC outlet, a rechargeable battery, a single-use

10 battery, a mobile phone, a tablet computer, a laptop computer, and a DC to AC converter.

10. The apparatus of any one of the preceding claims, wherein said power source and control unit further comprises a memory unit, the memory unit being configured to store at least one of the following: i) at least one treatment parameter, and ii) at least one physical parameter.

15 11. The apparatus of claim 10, wherein said power source and control unit is configured to control said at least one treatment parameter or said at least one physical parameter.

12. The apparatus of claim 11, wherein said treatment parameter comprises at least one of the following: treatment time, magnitude of the RF current, type of AC waveform,

20 AC frequency, temperature of the oral cavity, temperature of the deep tissue layers, magnitude of the voltage and duty cycle of the RF current.

13. The apparatus of claim 12, wherein said treatment time is in a range from about O.OlOsec to about 30min.

14. The apparatus of claim 12 or 13, wherein said AC frequency is in a range from 25 about 300 kHz to about 40.0MHz.

15. The apparatus of any one of claims 12 to 14, wherein said AC frequency is in a range from about 1.0MHz to about 10.0MHz.

16. The apparatus of any one of claims 12 to 15, wherein said waveform has one of the following shapes: a sine wave, a square wave, a triangular wave, and a saw-tooth

30 wave.

17. The apparatus of any one of claims 12 to 16, wherein said temperature of the deep tissue layers is in a range from about 39° C to about 48° C.

18. The apparatus of any one of the preceding claims, additionally comprising at least one sensor comprising at least one of the following: a thermistor, an optical sensor, an ammeter, an impedance meter, and a voltage meter.

19. The apparatus of claim 18, wherein said control unit is configured to store at least one measurement by said at least one sensor.

20. The apparatus of any one of claims 10 to 17, additionally comprising feedback control for said at least one treatment parameter, wherein said feedback control operates in method comprising steps of: (i) measuring a physical parameter and (ii) altering at least one said treatment parameter based on said measurement of said physical parameter.

21. The apparatus of any one of claims 10 to 17, wherein said physical parameter is related to at least one of the following: the formulation, the applicator, at least one electrode, the oral mucosa portion or a tissue in the vicinity of the oral mucosa portion, tissue reflectivity, tissue impedance, applicator temperature, electrode assembly temperature, formulation temperature, formulation impedance, current, and voltage.

22. A method of facial tissue rejuvenation treatment, comprising applying RF current of a predetermined profile to at least a portion of oral mucosa located opposite a facial skin tissue portion undergoing the facial tissue rejuvenation treatment; and maintaining said application of the RF current until a predetermined temperature profile is achieved in deep tissue layers under said portion of oral mucosa; thereby stimulating collagen formation in said deep tissue layers and tightening of said facial skin tissue portion.

23. The method of claim 22, further comprising simultaneously applying to said portion of oral mucosa, with said RF current, a formulation known for its collagen building stimulating effect.

24. The method of claim 23, wherein said formulation comprises Hyaluronic Acid.