WO2016151570A1

WO2016151570A1 - System and method for tissue whitning by applying electromgnetic field

Info

Publication number: WO2016151570A1
Application number: PCT/IL2016/050242
Authority: WO
Inventors: Orit Ron Edoute
Original assignee: Brighttonix Medical Ltd.
Priority date: 2015-03-25
Filing date: 2016-03-03
Publication date: 2016-09-29
Also published as: WO2016151570A9

Abstract

Tissue whitening system and method are provided. The system comprises an applicator unit comprising: a treatment surface comprising a plurality of treatment sites, each of the treatment sites being configured such that, when the applicator unit is in operation during a whitening treatment procedure, the treatment site is in contact with a whitening substance to apply treatment to a respective tissue portion via the whitening substance; and an electrode assembly configured to create a plurality of electromagnetic field regions within a treatment zone in the vicinity of the treatment surface, such that, when the applicator unit is in operation, the plurality of treatment sites are located in the plurality of the electromagnetic field regions thereby affecting the whitening substance at the treatment sites. The system further comprises an electromagnetic power source being in signal communication with the electrode assembly and configured to generate activation signals to operate the electrode assembly to create the electromagnetic field regions in at least some of the treatment sites; wherein each of the activation signals has a predetermined time-frequency profile to thereby apply an alternating electromagnetic field of the predetermined profile to the respective treatment site.

Description

SYSTEM AND METHOD FOR TISSUE WHITNING BY APPLYING

ELECTROMGNETIC FIELD

TECHNOLOGICAL FIELD

The present invention is generally in the field of medical applications, and relates to a system and method for tissue whitening. The invention can particularly be used for skin whitening or dental treatment for tooth/teeth whitening. BACKGROUND

Tissue whitening, in particular skin or teeth, is gaining significant attention recently in different parts of the globe. As commonly referred to, tissue whitening, or the so called tissue lightening/bleaching is the practice of using chemical compounds in an attempt to lighten the tissue tone or provide an even look to the tissue.

When talking about skin, the color tone is caused mainly by Melanin in the skin tissue. More abundance of melanin means darker skin. Thus, lightning skin is achieved by reducing the melanin concentration in the skin. Skin discoloration may also be caused by age or by overexposure to the sun. Several chemicals have been shown to be effective in skin whitening, while some have proven to be toxic or have questionable safety profiles, adding to the controversy surrounding their use and impacts on certain ethnic groups.

In medical literature, hydroquinone is considered the primary topical ingredient for inhibiting melanin production and accordingly for lightening the skin. However, some research results have shown hydroquinone to cause some types of cancer. Therefore, its use is banned in some countries and limited, with very little concentrations, in other countries.

In the case of teeth, discoloration of the teeth has many causes including consumption of staining materials such as coffee, tea or red wine, use of tobacco products, consumption of food or water with a high mineral content, and use of certain antibiotics. .

Many devices and materials have been developed for removing stains from teeth, both for home use and for use by a professional such as a dentist or dental technician or a tooth-whitening professional. Devices, materials and methods intended for home use are less effective than those intended for use by professionals. Because of this, home tooth whitening treatments usually either take significantly more time or are significantly less effective than the results obtained by professionals, either dentists or dental bleaching service providers.

Many materials contain strong oxidizers, such as hydrogen peroxide, a known bleaching agent. However, hydrogen peroxide, like many bleaching agents, is a known irritant which can cause pain and, sometimes, even inflammation if it comes in contact with tissue in the oral cavity. Typically, in home tooth whitening, a dental tray or an adhesive strip will be used to apply whitening material to the teeth. Unless a dam or other separation means is provided as part of the device, the whitening material can escape from the tray or around the edges of the adhesive strip and come in contact with the gingival tissue. Therefore, typically, the patient's gingival tissue is kept from contact with the whitening agent by including a rubber dam at the top of the tray or by covering the gingival tissue by a protective material such as a lacquer.

WO09/072108 discloses a skin treatment apparatus that includes a disposable electrode carrier with a plurality of voltage-applying dome-shaped elements protruding from the surface of the electrode carrier. Further, the protruding elements are spaced apart in a pattern. The apparatus operates to apply a voltage to at least some of the protruding elements. The apparatus applies a voltage to the protruding elements with a magnitude that is sufficient to result in an electrical break down of the skin and thereby cause electric current enabling the desired treatment. GENERAL DESCRIPTION

There is a need in the art to provide a novel tissue whitening technique which is effective, safe, easy to apply, enabling accessible way for home, as well as professional use (including dental and cosmetic clinics such as spa).

To this end, the present invention provides for a novel approach for tissue whitening, which may be implemented by simple yet strongly effective device and method, which is suitable for use in personal and professional whitening technique. The technique of the present invention provides the treatment results at the level of professional treatment while being safe, saving time and money. Additionally, as the technique can be made by the individual at home, it can be repeated as needed while saving the effort of repeatedly visiting professional clinics.

There is a need also to provide flexible, selective and controllable application of the whitening procedure, i.e. control over precise location of the treatment and/or control over the treatment parameter(s)/condition(s) of the specific tissue portion. For example, different tissue regions may be subjected to different profiles of the applied field, e.g. by differentiating the magnitude and/or duration and/or time pattern of the applied field to specific simultaneously treated tissue regions. For instance, when treating skin tissue, there might be a need to apply multiple intensities to different adjacent tissue portions. The present invention provides a flexible tissue whitening device which enables selective application of a plurality (at least two) of treatment modes of different conditions/parameters to different tissue sites at the same time or during the same treatment session, thus providing fast and effective treatment.

It should be understood that the term "whitening" treatment in this application should be interpreted widely, and it includes, inter alia, whitening of tissue, i.e. changing the tissue color to be closer in its characteristics to the white color. Further, the term may be interpreted also as brightening of tissue. However, a treatment which causes the color of the tissue to be more uniform or homogeneous with respect to its surrounding is also included in the meaning of whitening as used in this application (e.g. removal/reduction or pigment spots, typically developing with aging or various abnormalities).

The inventors have found that application to the tissue portion a whitening substance, e.g. a substance based on a regular toothpaste, together with application of a customized alternating electromagnetic field / alternating current (AC) to the whitening substance and/or tissue under treatment (typically, skin region or at least one tooth) provides relatively short and safe treatment procedure leading to the results comparable with professional long-term and less safe / less comfortable treatment (as described above).

It should be noted that for the purposes of the present application the term

"regular toothpaste " refers to a toothpaste having no oxidizing agents (such as used in conventional teeth whitening procedures), and may be any known suitable commercially available toothpaste, but preferably of the type containing teeth whitening agents and/or hyaluronic acid. This makes the tissue whitening procedure more safe and simple.

Some specific but not limiting examples of the suitable toothpaste include the following: Aquafresh multi-action +whitening, Oral-B complete mouthwash + whitening, Colgate MaxWhite One, Colgate Optic White, Colgate Sensitive Whitening, Dr. John's Formula Toothpaste Gel.

Also, it should be noted that in the description below the terms "regular toothpaste", "whitening toothpaste", "whitening substance" and "whitening material" are used interchangeably, all relating to a whitening substance, e.g. regular toothpaste, without strong oxidizing agents (such as conventionally used hydrogen peroxide). In some embodiments of the invention the "regular toothpaste" is modified to include ferromagnetic particles (e.g. nanostructures) embedded therein and/or hyaluronic acid. Thus, the term "whitening substance based on a regular toothpaste" refers to the regular toothpaste itself or the regular toothpaste with the embedded magnetic particles and/or hyaluronic acid.

It should be noted that for the purposes of the present invention, the term "electromagnetic field" should be interpreted broadly covering at least "electric field", "magnetic field", or "electromagnetic field" utilizing both electric and magnetic energies. Such electromagnetic field may be a directly applied AC field inducing AC current or that resulting from application of AC current. Thus, the term "AC current", used herein, is interchangeable with "alternating field", whether being an electric or a magnetic field causing said alternating current.

The inventors have found that the application of AC electric field having certain time and frequency pattern (i.e. being a function of time and/or frequency) to a regular toothpaste (or the tissue contacting the toothpaste) during a treatment session (i.e. when the whitening substance is in contact with tissue) provides for remarkable improvement of several shade degrees in accordance with the common shading grading, while in a relatively short duration of the treatment session (in comparison to the common professional practice) and without a need for strong oxidizing agents in the whitening substance. Preferably, the AC field application during the treatment session is continuous, but generally a proper pulsed mode can be used.

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 invention, there is provided a tissue whitening device comprising:

an applicator unit comprising: a treatment surface comprising a plurality of treatment sites, each of the treatment sites being configured such that, when the applicator unit is in operation during a whitening treatment procedure, the treatment site is in contact with a whitening substance to apply treatment to a respective tissue portion via the whitening substance; and an electrode assembly configured to create a plurality of electromagnetic field regions within a treatment zone in the vicinity of said treatment surface, such that, when the applicator unit is in operation, said plurality of treatment sites are located in said plurality of the electromagnetic field regions thereby affecting said whitening substance at said treatment sites; and an electromagnetic power source being in signal communication with said electrode assembly and configured to generate activation signals to operate the electrode assembly to create the electromagnetic field regions in at least some of the treatment sites; wherein each of the activation signals has a predetermined time- frequency profile to thereby apply an alternating electromagnetic field of the predetermined profile to the respective treatment site.

As indicated above, the treatment sites are configured such that, when the applicator unit is in operation, the treatment sites can be in contact with the whitening substance. This can be implemented by configuring the treatment site as a groove/recess made in the treatment surface such that the whitening substance is hold inside the groove; or by configuring the treatment site as a protrusion from the treatment surface such that the treatment site penetrates into the whitening substance applied directly to the tissue to be treated.

The electromagnetic power source may comprise an electromagnetic signal generator for generating an alternating activation signal, and a control unit configured for modifying said activation signal by a predetermined control function to create said predetermined time-frequency profile of the activation signal.

In some embodiments, the applicator unit is configured to wrap a tissue region or organ undergoing whitening treatment procedure. At least some of said treatment sites comprise compartments configured to receive therein a whitening substance. The treatment sites may be different from each other in at least one of the following: i) their shapes, ii) their volumes, and iii) their surface area facing the respective tissue portion undergoing the whitening treatment procedure.

In some embodiments, the electrode assembly comprises a single electrode unit. In some embodiments, the electrode assembly comprises a plurality of spaced- apart electrode units. In some embodiments, at least some of these electrode units are operated in bipolar configuration. In some embodiments, at least one of the electrode units is operated in monopolar configuration. The plurality of the spaced-apart electrode units may form a three-dimensional array of electrode units. In some embodiments, the electromagnetic power source activates each of the electrode units by a respective activation signal having a respective predetermined time- frequency profile. The activation signal may be an AC current.

In some embodiments, the electromagnetic power source is locatable in a unit separate from said applicator unit. The electromagnetic power source may comprise at least one of the following: a rechargeable battery, a single -use battery, a mobile phone, a tablet computer, and a laptop computer plus a DC to AC converter.

In some embodiments, the control unit 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 control unit may be configured to control said at least one treatment parameter or said at least one physical parameter of the whitening substance. The treatment parameter may comprise at least one of the following: treatment time, magnitude of the current, type of AC waveform, temperature of said tissue portion or of a tissue in the vicinity of the tissue portion, magnitude of the voltage, AC frequency, duty cycle of said current, and change in color of said tissue. The treatment time may be in a range from about O.OlOsec to about 30min. The AC frequency may be in a range from about 300 kHz to about 40.0MHz, or preferably in a range from about 1 MHz to about 10 MHz. The AC waveform may be configured in one of the following shapes: a sine wave, a square wave, a triangular wave, and a saw- tooth wave. The temperature may be in a range from about 39° C to about 48° C.

In some embodiments, the tissue whitening device comprises 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.

In some embodiments, the tissue whitening device comprises feedback control for said at least one treatment parameter, wherein said feedback control can be implemented by (i) measuring a physical parameter and (ii) altering at least one said treatment parameter based on said measurement of said physical parameter. 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 the measurement for one portion of the tissue and the measurement for another portion of the tissue, the difference between change in measurement for one portion of the tissue and the change in measurement for another portion of the tissue.

In some embodiments, the physical parameter is related to at least one of the following: the whitening substance, the applicator unit, at least one electrode unit, the tissue portion or a tissue in the vicinity of the tissue portion, tissue reflectivity, tissue impedance, tissue color, tissue temperature, applicator unit temperature, electrode unit temperature, whitening substance temperature, whitening substance impedance, current, and voltage.

In some embodiments, the electrode assembly is coupled to the whitening substance by one of the following: a capacitive coupling, and a conductive coupling. In the case of capacitive coupling, the electrode assembly may be covered by a non- conductive material. The non-conductive material may be of a thickness in a range from about 0.05mm to 0.2mm.

In the case of conductive coupling, at least one of the following holds true: (a) at least a portion of at least one surface of said electrode assembly is bare, at least a portion of said bare portion of said surface is exposable to said whitening substance, and (b) at least a portion of at least one surface of said electrode assembly is covered by a conductive material.

The applicator unit is either single-use (disposable) or reusable. In some embodiments, the location of the electrode assembly in the applicator unit is selected from one or more of the following: embedded in said applicator unit, on a surface of said applicator, and proud of the surface of said applicator. The stiffness of the applicator unit may be selected from at least one of the following: flexible, semi-rigid, and substantially rigid. The applicator unit may comprise a biocompatible, nonconductive polymer selected from at least one of the following: silicone, a foam material, nylon, and PVC.

In some embodiments, the tissue undergoing a whitening treatment is skin tissue. The applicator unit may comprise at least one of the following: a glove, a fingerless glove, a tube configured to fit a finger, a tube configured to fit a toe, a boot, a boot with integral toes, a mask configured to fit the face, a nose-cap configured to fit over the nose, a chin-cap to fit over the chin, a cap to fit over the head, an ear-cap to fit over an ear, and a substantially flat band. The substantially flat band may be configured to fit the forehead, the neck, the arm, the chest, the hips, the waist, the thigh, the knee, the calf, the ankle, the foot, a finger, a toe and any combination thereof. The applicator unit may be retained in position by at least one of the following: a tie, a buckle, an elastic band, Velcro™, a clip, and a clip-on band.

In some embodiments, the tissue undergoing a whitening treatment is teeth tissue. The applicator unit is configured as a dental tray and each of said treatment sites is sized and shaped to enclose said whitening substance and at least one tooth. The applicator unit may comprise one or more of the following: a biocompatible, nonconductive polymer; cardboard; and molded paper pulp.

The whitening substance may comprise at least one of the following: a regular, commercially available, toothpaste; a regular, commercially available, whitening toothpaste; a commercially-available skin treatment material; a commercially-available skin whitening material, specially formulated skin whitening material, and skin tightening material.

According to another broad aspect of the invention, there is provided an applicator device, for use in a tissue whitening device, the applicator comprising: a treatment surface comprising a plurality of treatment sites, each of the treatment sites being configured such that, when the applicator is in operation during a whitening treatment procedure, the treatment site is in contact with a whitening substance to apply treatment to a respective tissue portion via the whitening substance; and an electrode assembly configured to create an electromagnetic field within a treatment zone in the vicinity of said treatment surface, such that, when the applicator is in operation, the electromagnetic field is induced in at least said whitening substance at said treatment sites.

According to yet another broad aspect of the invention, there is provided a method of tissue whitening comprising: applying a layer of a whitening substance to at least one tissue portion; applying to said at least one tissue portion, covered by the layer of the whitening substance, an alternating electromagnetic field according to a predetermined activation function having one or more frequencies in a range from a few hundreds of kHz to a few tens of MHz; and maintaining the application of said alternating electric field for a predetermined duration of a treatment session, thereby whitening said at least one tissue portion.

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 a system of the present invention;

Figs. 2A-2D schematically illustrate examples of applicator embodiments for skin whitening used in the present tissue whitening system;

Fig. 3 schematically illustrates an applicator embodiment for teeth whitening used in the present tissue whitening system;

Fig. 4 schematically illustrates an embodiment of the electrodes that may be used with the invention;

Fig. 5 schematically illustrates an embodiment of segmented electrodes that may be used with the invention;

Fig. 6 schematically illustrates an embodiment of the electrodes that may be used with the invention;

Fig. 7 schematically illustrates one more embodiment of the electrodes that may be used with the invention;

Fig. 8 is an example of a tray used in the present whitening method for concurrent whitening of the upper and lower teeth sets

Fig. 9 is an example of a power supply and control unit for use with the whitening device; and

Figs. 10A-10D depicts AC waveforms that may be used for generation of the AC current. DETAILED DESCRIPTION OF EMBODIMENTS

The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a medical treatment. The device and method of the present invention can be used for tissue treatment, particularly to whiten the tissue, such as skin tissue and teeth tissue.

The present invention provides a novel tissue whitening device, which is advantageously configured to improve safety and reduce the cost of the tissue whitening treatment procedure, as well reduce the time it takes to achieve desirable results in a residential and professional environment. Typically, the desired results are at least those achievable with respect to tissue whitening in a convention professional procedure.

Many materials currently on the market are used to whiten or bleach teeth, some intended for use by professionals, some for home use. Most require a consumable bleaching or whitening material and, for most, the consumable material is a specially formulated material designed to work with one particular device. Frequently, such specially formulated materials are significantly more expensive than more general- purpose materials.

Materials for dental bleaching for use in the home typically are less effective than materials for use by professionals such as a dentists or dental technicians, or professional dental bleaching service providers, so that they either take more time to achieve the desired whitening, or the results are less satisfactory, in that less whitening is achieved.

Toothpaste, applied (with the help of a brush) to the teeth in order to clean the teeth, is a solid or gel phase of different components suspended in an aqueous phase. Almost all commercially available types of toothpastes include a lot of similar ingredients. These ingredients could be: abrasives such as baking soda, hydrated silica, detergents that create the foaming action associated with toothpastes use; humectants that retain moisture and prevent the toothpaste from not drying out; fluoride that maintains tooth resistance to acids and bacteria; preservative that prevent the growth of microorganisms in toothpaste; flavoring agents and sweeteners that improve the taste of toothpaste and a bleaching component that could be hydrogen peroxide, Sodium Lauryl Sulfate, hydrated silica, Pentasodium Triphosphate, Tetrasodium Pyrophosphate and Tetrapotassium Pyrophosphate and others.

Some of the toothpastes could include one or more coloring agents that provide the toothpaste a pleasing color and disinfectants. Toothpastes have been used for many years and no adverse effects have been communicated by users of the toothpastes.

The inventors of the present invention have found that when a layer of whitening substance (e.g., a regular toothpaste) is applied to tissue in the body and alternating electromagnetic field is applied, to the tissue being covered by a layer of whitening substance/regular toothpaste, the application of the AC signal to the whitening substance/regular toothpaste whitens the tissue. The regular toothpaste could be applied to the tissue in a number of ways including use of a suitable bandage, a patch, a dental tray, a brush or other paste deposition means.

It should be noted that applying heated toothpaste to the teeth without application of electric current does not whiten teeth significantly more than the minimal whitening of unheated toothpaste. Furthermore, applying DC current to the toothpaste- covered teeth also does not significantly affect whitening.

The mechanism by which the present process whitens tissue may be based on that AC current has at least one of the following effects on the toothpaste: (a) the current causes an electrochemical reaction that decomposes one or more components of the toothpaste, with at least one of the decomposition products having a significantly increased whitening effect or (b) the current causes a catalytic reaction in the toothpaste, thereby significantly increasing the reaction rate for one or more of the whitening reactions normally occurring when the toothpaste is used.

Reference is made to Fig. 1 showing a schematic block diagram of a device 10

(medical or cosmetic) configured in accordance with the present invention. As shown in the figure, the device 10 includes an applicator 100, and an electromagnetic power source device 400. The applicator 100 and the power source 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 device 400 may be integrated with the applicator 100, being a constructional part of the applicator, and being operable either using a battery or connection to a power network. As also shown in the figure as alternative option, the power source device 400 may be placed in a separate housing / package 20. In yet another example, the elements of the power source device 400 may be distributed between the applicator unit 100 and separate package 20.

The applicator 100 includes an electrode assembly 110, configured to be in electric communication with the electric power source unit 400, via the connection 200. The applicator 100 is therefore at times referred to below as "electric applicator". The electrode assembly 110, when operated (supplied with electric signal), creates one or more of alternating field regions, generally at 101, in the vicinity thereof.

It should be understood, that generally, the electrode assembly may include at least one electrode (keeping in mind that the subject's body may serve as the counter electrode), or may include at least one pair of electrodes. Preferably, as will be described further below, the electrode assembly is configured to create a plurality (one- or two-dimensional array) of electric field regions. These field parameters/conditions in the multiple field regions are preferably separately controlled/operated. This may be achieved by providing a plurality (array / matrix) of spaced-apart electrodes, where either each electrode or each group of electrodes is separately operated. Such electrode assembly, when operated, creates multiple field regions associated with respective multiple treatment sites on the tissue.

The applicator 100 includes a treatment surface 102 which is configured to be placed on the tissue undergoing treatment. The treatment surface 102 may touch the tissue or may not touch the tissue directly. Usually, the whitening substance (not shown) used with the treatment procedure is placed in between the treatment surface and the treated tissue. The treatment surface 102 includes a plurality of spaced-apart treatment sites 104 defined and configured to contact the whitening substance, such that the treatment sites define tissue-substance contact regions 106.

In this connection, the following should be noted: Practically, the applicator 100 is configured for mounting on the tissue region/part undergoing the treatment (e.g., a skin portion, the lower or upper teeth arcades). However, when a selected tissue portion (e.g., local skin portion inside the tissue portion, or one or more teeth) is to be treated, the applicator can be configured accordingly by activating the relevant treatment site on the treatment surface. For example, the applicator may be placed on skin of a whole finger (wrapping the finger), while a treatment is applied selectively to one or various skin portions of the finger. In another example, when selected tooth/teeth is/are to be treated, the technique of the present invention allows for using a typical dental tray mountable on the entire teeth arcades, the tray includes a plurality of treatment sites configured to apply treatment to a single or plural number of teeth. Advantageously, according to the invention, no strong oxidizing agents are needed and therefore treatment of a selected tissue, while the applicator and whitening substance are placed on a tissue portion larger than the treated one, would not damage the neighboring tissue.

When the applicator 100 is mounted on (applied to) the individual's tissue, the tissue and the whitening substance are in contact with each other in the tissue-substance contact region 106, and this tissue-substance contact region 106 becomes located inside the alternating field region 101 thereby defining a treatment zone 106 where treatment by AC field is applied during the treatment session.

The power source 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 housing / package 20, or may be placed in two separate housings 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 housing. It might be more practical that the power generator is integral with the electric applicator, while the control unit is a separate unit which controllably modifies the electric signal generated by the power generator by a predetermined activation function and possibly its settings are updated for a specific individual (via user interface) 450. In some embodiments, the AC power generator is integral with the applicator and is controlled by specially designed application for personal electronic devices, such as smartphones and tablets. To this end, the control unit is at least partially embedded in such personal electronic device.

As indicated above, the electrode assembly 110 includes at least one electrode configured for applying the AC current to the whitening substance. In some embodiments, the electrode assembly 110 may include more that one electrode, such as two or more. For example, the electrode assembly 110 applies the AC current by a capacitive coupling mode, in which case the assembly 110 may include at least one pair of spaced-apart electrodes with the whitening substance in the space between the two electrodes. In some other examples, the AC current is produced using conductive coupling mode. More details about the different coupling modes are further detailed below. In some further embodiments, the electrode assembly 110 may include an array of electrodes spaced by the region(s) in which the whitening substance, and possibly the tissue, is (are) situated.

It should be understood, the electrode assembly 110 may include a single electrode configured to apply alternating field in the treatment zone, via one or more treatment sites. Alternatively, the electrode assembly may include a plurality of electrodes, such that each electrode is configured to apply the alternating field to one or more treatment sites 104. In one specific embodiment, the number of electrodes may be equal to (or twice of) the number of treatment sites 104, such that each treatment site is operated by a single electrode (or a pair of electrodes, e.g. in capacitive coupling mode).

In preferred variants of embodiments with more than one electrode, the electrodes are individually controllable. For 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.

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. In such embodiments, at least one sensor 456 is configured to measure a parameter related to the tissue under treatment, such as a tooth, the oral cavity or a skin portion. The parameter may also relate to the substrate, the applicator, at least one electrode in the electrode assembly. The parameter can be related to tissue characteristics such as reflectivity, impedance, color, 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 whitening result. For non-limiting example, if the sensor 456 determines that a desired change in shade has been achieved for a tissue portion, the control unit can discontinue treatment for that tissue portion, while continuing treatment to other tissue portion(s). Similarly, if a tissue portion is whitening 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 electromagnetic field to it.

The power source unit 400 is responsible for generating the electric/magnetic signals which are then transmitted (via the operation of the control unit to provide desired profile of said signals) to the electrode 110 in the applicator 100, in order to generate the AC electric field / current which acts on the whitening substance (which is typically electrically conductive) and causes the bleaching of the tissue. The AC current causes an electrochemical reaction (decomposition) within the whitening substance (regular toothpaste) that breaks down the components thereof and at least one of these components causes the tissue whitening effect. For example, some bleaching ingredients of a toothpaste may be bonded to chromophores (which typically color the teeth) on the teeth and destroy the chromophores as a result of the high frequency AC current (i.e. that changes its direction very rapidly, e.g. few millions times per second). As indicated above, the regular toothpaste may comprise magnetic particles embedded therein. In this case, application of alternating magnetic field of a desired profile results in a corresponding motion pattern of the magnetic particles in the toothpaste. This motion has rapidly varying motion vector affecting interaction between the ingredients of the toothpaste and the teeth resulting in the teeth whitening.

As briefly described above, the power source 400 includes the power generator 430 which physically generates the electric/magnetic field / 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 substance controller 451, configured for measuring / monitoring one or more parameters of the whitening substance (material status), which may be indicative of the treatment process, such as for example measurement of impedance of the of the whitening substance, as will be described further below. The substance controller is actually associated with a measurement / sensing circuit (electric, optical, electro-optical, etc.), which is typically integral with the applicator and connectable (via wires or wireless) to the substrate 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 treatment (whitening) process, such as one of the following: control the amount and location of the toothpaste, custom formulated whitening substance between the applicator and the tissue. As will be described further below, the power source unit 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 whitening 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 field/signals to form a desired AC electric 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 field activating signal. It should be understood that in case the power generator is configured to be directly connected to a power network, the power generator or the control unit (as the case may be) includes an AC- DC converter and 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 electric signal is relatively high, e.g. of a few hundreds of kHz and up to the range of MHz. The amplitude may be in the range from 3Vrms up to 50Vrms. 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 alternating electric field 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 control unit also includes a suitable user interface 450 which enables the user to control the whole treatment session, by defining each of the parameters of the activation function and its duration.

Thus the device of the present invention provides full control over all the parameters needed to execute a successful and effective tissue whitening 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 prior to supplying the device, or only the control unit, to the user, and/or may give the user access for updating / adjusting the parameter(s).

The above described device may be supplied in a specific kit for use in tissue whitening treatment (professional or home use). The kit includes a set of one or more electric applicators, one or more power source units, and one or more toothpaste packages. The toothpaste package includes a regular toothpaste, e.g. toothpaste containing whitening agent(s); or toothpaste (with or without whitening agents) containing magnetic particles therein; or toothpaste (with or without whitening agents, and with or without magnetic particles) containing or accompanied with hyaluronic acid.

As said above, the invention is especially useful for treating skin or teeth. Herein below, several possible embodiments illustrating the applicator are listed.

The device of the present invention can be used for treating skin. One non- limiting example is removing freckles or age spots. In such case, the device comprises an applicator adapted to fit against the skin and to retain a substrate against the skin, with the applicator comprising electrode(s), as described above. In a non-limiting example, the number of electrodes in a skin-treatment device can be typically in the range from 1 to 100.

The treatment substrate can be a whitening material. The whitening material can comprise commercial toothpaste, a commercial skin whitening cream, or a specially- formulated whitening material.

The applicator may comprise a substantially flat band, and may be shaped to fit a portion of the anatomy of the treated organ or part of the body. The substantially flat band is preferably flexible and configured to fit to the various anatomy shapes of the body. However, the applicator may be made from a rigid or semi-rigid material(s), and in this case, several costumed applicator shapes may be supplied.

The applicator for skin treatment is preferably shaped so that the whitening material is retained between the applicator and the skin, with substantially none of the whitening material escaping outside the perimeter of the applicator. In some embodiments, the applicator may be provided with compartments that are configured to receive the whitening material therein. In some other embodiments, the applicator is configured to hold a whitening material embedded in a specially designed grooves or pockets which are configured to controllably release the whitening substance onto the tissue when required.

Reference is made to Figs. 2A-2D illustrating non-limiting examples of skin treating applicators 700 with substrate 720 in position. The portion of the anatomy to which an applicator would be applied is not shown. Ties or other fastenings to hold the applicator 700 in place are not shown. The applicator 700 can have a substantially flat cross-section through its thickness (Fig. 2A); it can have a domed cross-section (Fig. 2B), with the center of the dome bulging away from the skin; it can have a triangular (Fig. 2C), rectangular (Fig. 2D) or other polygonal cross-section (not shown) and any combination thereof.

In some embodiments, the applicator has an elastic edge, configured to hold the edges of the applicator against the skin. Generally, the applicator can be held in place by one or more of the following mechanisms: a tie, a buckle, an elastic band, Velcro™, a clip, a clip-on band, and any combination thereof.

An applicator shaped to fit a portion of the anatomy can be in the form of a glove, a fingerless glove, a tube configured to fit a finger, a tube configured to fit a toe, a boot, a boot with integral toes, a mask configured to fit the face, a nose-cap configured to fit over the nose, a chin-cap to fit over the chin, a cap to fit over the head, an ear-cap to fit over an ear, and a substantially flat band.

The substantially flat band can be configured to fit the forehead, the neck, the arm, the chest, the hips, the waist, the thigh, the knee, the calf, the ankle, the foot, a finger, and a toe.

In some embodiments, for at least two electrodes, the distance between the electrodes is adjustable. In preferred variants of these embodiments, it is the distance between electrodes in the flat band that is adjustable.

As mentioned above, the invention provides also a powerful teeth whitening technique. In preferred embodiments, the device of the present invention comprises a dental tray constructed to fit around at least one tooth of the upper and lower sets of teeth. The tray comprises a cavity or channel for containing the toothpaste and receiving the tooth or teeth, and electrodes for applying the AC current. If plurality of teeth are simultaneously treated, In preferred embodiments, the electrodes are individually controllable so that treatments can be different for different teeth. The tray can be either a disposable tray or a reusable tray.

Fig. 3 shows an embodiment of an applicator unit 1000 for use in a teeth whitening procedure. As shown, the applicator is in the form of a dental tray (herein below, applicator and tray are used interchangeably). In this non-limiting example, the dental tray 1000 comprises a treatment surface 1040 in the form of a cavity or channel into which the teeth are inserted for treatment. The treatment surface 1040 includes two treatment sites 1042 and 1044 which are configured to apply whitening treatment to the teeth via a whitening material which is also inserted into the channel 1040 and the channel 1040 is configured to retain the whitening material against the teeth. The applicator further includes an electrode assembly 1105 which is configured to apply alternating electromagnetic field to the teeth. In this example, the electrode assembly includes two electrodes 1110 and 1120 positioned at the treatment sites 1042 and 1044 respectively. The electrode assembly is activated by an activation signal generated by the power source (not shown) through a connection 1130 (e.g. a wired connection).

In some embodiments, the applicator 1000 also comprises a thermistor which monitors the temperature during the whitening process. The thermistor can be embedded in the applicator tray 1000, attached to the surface of the tray, preferably in the channel 1040, or can stand proud of the tray 1000. In preferred embodiments, the temperature in the oral cavity is 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 dental tray 1000 can be rigid or flexible. Preferably, it is sufficiently stiff such that the whitening material can be placed therein without significant deformation of the tray 1000 and such that, during use, deformation of the tray is sufficiently small that the whitening material substantially remains therein.

The dental tray 1000 can comprise cardboard; molded paper pulp; a biocompatible, nonconductive polymer such as, but not limited to, silicone, a foam material, nylon, or PVC; and any combination thereof.

The dental tray 1000 can be shaped to fit around, and therefore whiten, a predetermined number of teeth in a predetermined region of the mouth; a single set of teeth, as shown in the embodiment of Fig. 3; or both sets of teeth, as shown in Fig. 8 below.

The electrodes 1110 and 1120 can be embedded in the walls of the tray 1000, can be attached to the surface of the tray 1000, selectively plated or coated on the walls of the tray 1000 and any combination thereof. In preferred embodiments, the electrodes follow the perimeter/contour of the walls of channel 1040. An electrode can be in one piece (unitary), or can comprise a plurality of segmented electrodes as will be shown more specifically further below. In some embodiments, the tray comprises a plurality of electrodes, with each electrode whitening a predetermined number of teeth. For non-limiting example, for whitening the upper teeth using pairs of electrodes, one pair of electrodes whitens the right rear molars (teeth 1-3), a second pair whitens the right front molars (teeth 4-6), a third pair whitens the canines and the incisors (teeth 7-10), a fourth pair whitens the left front molars (teeth 11-13), and a fifth pair whitens the left rear molars (teeth 14-16). Typically, the maximum number of electrodes would be 64, one pair for each tooth in the mouth, or a multiplication of 64, if more than one electrode pair is allocated for each tooth.

Figs. 3 and 4 show two embodiments with two unitary electrodes. As mentioned, Fig. 3 shows electrodes 1110 and 1120 embedded in a tray 1000, while Fig. 4 shows an embodiment of electrodes 1100 only, with the two electrodes 1110 and 1120 and the connection 1130, however without the tray. In use, the electrodes can be embedded in a tray, on the surface of the tray, clear of the tray, in a channel or cavity and any combination thereof.

An electrode providing a capacitive coupling can be covered by a layer of non- conductive material, for non-limiting example, by embedding it under the surface of the tray. If the electrode is covered by tray material, the thickness of the layer of tray material is typically in a range between about 0.05mm and about 0.2mm.

An electrode providing a conductive coupling can be left exposed (bare) or one or more surfaces can be partially or fully covered by a layer of conductive material. The means of covering can be selective plating, coating with conductive material and any combination thereof.

The electrodes (1110, 1120) are preferably made of a bio-compatible conductive material such as, but not limited to, stainless steel, titanium, gold and any combination thereof.

Fig. 5 shows an embodiment of electrodes 1200 with a plurality of pairs of electrodes 1210 and 1220. The electrodes are electrically connectable to the power supply 430 and, to the control unit 444 via the reversible connector 1130. In preferred embodiments, each electrode (1210, 1220) is individually connected to the power supply 430 and to the control unit 444 so that each electrode (1210, 1220) can be individually controlled.

Communication between the control unit 444 and the individual electrodes is schematically shown by fixed connectors 1250. The communication typically comprises the current and voltage to be applied to the teeth by the electrodes.

In Fig. 6, an embodiment of the electrodes 1300 is illustrated in which there are a plurality of outer electrodes 1220 and there is a unitary inner electrode 1110. Communication between the control unit 444 and the individual outer electrodes is schematically shown by fixed connectors 1250. In some embodiments, the outer electrode 1220 is unitary, while there is plurality of inner electrodes 1110.

In reference to Fig. 7, another non-limiting example of an applicator 1400 is shown with a single row of electrodes 1210. Communication between the control unit 444 and the individual electrodes is schematically shown by fixed connectors 1250; the electrodes are connected to the power source 430 via a reversible connector 1130.

Fig. 8 shows an embodiment of a dental tray 2000 for concurrent whitening of both the upper and lower teeth arcades, comprising an upper portion 2000A for whitening the upper teeth and a lower portion 2000B for whitening the lower teeth. The upper 2000A and lower 2000B portions can be unitary or they can be separate parts joined together by any means known in the art.

The connector to the power source comprises two separable components, a tray portion 1232 and a cable portion 1235. The upper tray 2000A comprises at least one electrode 2100 and the lower tray 2000B comprises at least one electrode 2200. In some embodiments, the number of electrodes per tray is in the range from about 1 to about 100.lt should be noted that the two trays 2000A and 2000B need not have the same number of electrodes and it all depends on the specific application and the individual's teeth situation.

The tray portion of the connector 1232 is reversibly connectable to the cable portion 1235, which provides a wired connection to the power source and to the control unit. The proximal end of the wired connection is connectable to the power source and/or the control unit. The proximal connection can be separable or it can be non- separable. Any connection means known in the art can be used to provide the wired electrical connection between the tray and the power supply and control unit.

In this example, thermistors 2700 are mounted to the tray to monitor the temperature during the whitening process and to prevent the temperature from becoming high enough to cause pain or harm the teeth, or to cause unwanted chemical reactions in the whitening material. In some embodiments, as disclosed above, there is no thermistor. A thermistor can be embedded in the tray, on a surface of the tray, stand proud of the tray by being, for example, embedded in the whitening material during use, and any combination thereof.

In reference to Fig. 9, a schematic illustration of an embodiment of the device

10 of the present invention is shown. In this non-limiting example, the applicator is one used to treat the teeth, however it should be understood that any other applicator can be used, including an applicator for use in skin treatment. As shown in the figure, a power source unit 1900 located in a separate housing 1950, and an applicator (a dental tray) 1000 are connected together with the help of wired connection 1800. It should be noted that a wireless connection may be established instead of the wired connection. The dental tray 1000 includes a channel 1040 and electrodes 1110 and 1120. A control unit (hardware/software), installed in the power source unit, includes a user interface including external controls 1910 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, magnitude of the voltage, AC frequency, and any combination thereof. The control unit can also include one or more display means 1920 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 1920 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 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.

Preferably, the frequency of the current is 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. If the alternating signal is an alternating electric current, the RMS amplitude of the current can be in the range from about 0.005 amp to about 1.0 amp. Preferably, it is the range from about 0.05 amp to about 0.5 amp. The RMS power can be in the range from about 0.005 W to about 5.0 W. Preferably, it is the range from about 0.05 W to about 3.0 W.

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 reference to Figs. 10A-10D, the waveform can be of any useful shape. For example, the waveform can be a sine wave (Fig. 10A), a square wave (Fig. 10B), a triangular wave (Fig. IOC), a saw-tooth wave (Fig. 10D), and any combination thereof.

A non-limiting example of a treatment using the device of the invention includes the following steps: (a) setting the parameters of a treatment; (b) filling an applicator, e.g. a dental tray (1000, 2000), with a substrate; (c) placing the dental tray (1000, 2000) in the mouth; (d) closing the mouth so as to retain the tray stably in position; (e) starting the treatment by activating the power source (f) waiting until the treatment is complete; and (g) removing the tray from the mouth. In some embodiments, the connector (1230, 1232) can be used as a handle when the tray is placed in the mouth or removed from the mouth.

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.

Parameters of the whitening process such as the treatment time, treatment process temperature change, applied current and current application duty cycle can be determined from the impedance of the tooth paste or custom whitening material.

In preferred embodiments, the device is configured to control the amount and location of the tooth paste and/or or custom whitening material within the tray cavity or channel 1040 and alerts the user if the cavity or channel 1040 contains a sufficient amount of the whitening material.

In some embodiments, the device, e.g. the control unit 444, can include a database to store physical parameters of whitening materials 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. In preferred variants of such embodiments, the device is configured to measure parameters of the whitening material. In further preferred variants of such embodiments, the device is configured to identify whitening materials from the physical parameters and to set treatment parameters based on the identification.

Although the embodiments disclosed above use commercially-available toothpastes, in some embodiments, existing specially formulated whitening materials can be used with the device, and in some embodiments, a whitening material formulated specifically for use with the device disclosed herein can be used.

It should be noted that, with the current device and method, the tissue whitening effect, in particular teeth whitening, occurs without use of hydrogen peroxide. This is advantageous since, outside the USA, the concentration of H202 tends to be limited to 0.1%, a concentration insufficient to whiten teeth using either professional or in-home treatments. It should be further noted that there is no need to isolate or otherwise protect a user's gingival tissue from the whitening material, since the device of the present invention uses commercial toothpastes which do not cause discomfort or damage to the gingival tissue.

Tests were performed on fifteen extracted teeth using the following commercially available toothpastes: Colgate Max White One, Colgate Total, Aquafresh Fresh, Colgate Max Fresh, Oral B Proexpert, Arm & Hammer Advanced White, Aquafresh Extreme Clean Pure, Sensodyne Repair & Protect Toothpaste, Sensodyne Pronamel Toothpaste, Arm & Hammer Enamel Pro Repair Sensitive, Oral B 123 Paste, Oral B Proexpert All Around, and Oral B Paste Complete Extra Fresh.

In the tests performed herein, there did not appear to be a correlation between waveform shape and effectiveness for the sine, square, triangular and sawtooth waves tested.

"Effectiveness" of tooth whitening can be characterized by a number of parameters. For example, (a) number of shades of color removed or shade achieved during one treatment, (b) time required for a single treatment or a predetermined number of treatments to achieve a desired tooth shade, and (c) duration of the tooth whitening effect.

Effectiveness can be measured in absolute terms, for example, by comparing the change in number of shades between a standard tooth whitening technique and the present treatment, or in relative terms, for example by comparison with an untreated control tooth.

Tooth shade as used in the current disclosure is measured by means of a scale of which the whiteness and brightness of a tooth can be classified. Comparison of the effects of the tooth whitening treatments was made using the VITAPAN classical shade guide. The VITAPAN shade guide uses 16 colors arranged into four groups based on the hue and within the group of increasing Chroma. Hue is categorized by letter with A = Orange, B = Yellow, C = Yellow/Gray and D = Orange/Gray. Chroma is categorized by number with 1 = least chromatic, 4 = most chromatic. Therefore, a tooth with shade value XI is whiter than a tooth with shade value Y4. For example, C2 will appear paler than D3. Table 1 summarizes the test results.

Whitening Parameters Shade Value

Tooth

Toothpaste Current Time Temperature Initial Post #

(mA_RMS) (min) (°C) Whitenim

1 Colgate Max White 20 between 42-45 C4 B2 One

2 Colgate Max White 20 — D4 C2 One

3 Colgate Max White 20 between 42-45 C3 C3 One No electrical current.

Toothpaste heated in

"bain-marie"

4 Colgate Optic White 250 20 between 42-45 A3 B l

5 Colgate Optic White 250 20 between 42-45 C4 D3 Colgate MaxWhite 250 20 between 42-45 C2 C2 WITH

MICROCRYSTALS

Aquafresh 250 20 between 42-45 B2 B l MULTI-ACTION

+ WHITENING

Aquafresh 250 20 between 42-45 C2 CI MULTI-ACTION

+ WHITENING

Oral-B complete 250 20 between 42-45 °C B3 B2 The current tooth whitening method has proved to be substantially better than the existing tooth whitening techniques. The cost of a regular commercially available toothpaste is substantially lower than the cost of special tooth whitening gels; the treatment time of a single session is five to twenty five minutes and is substantially shorter than the treatment time by the existing gels accompanied by DC current or LEDs light, which is usually 20 to 60 minutes for a single session. The number of shades whitened at a single teeth whitening session varied from two to seven shades. A single teeth whitening session has been required to reach tooth whitening results similar to the results achieved by six to ten sessions using the existing tooth whitening gels accompanied by DC current and/or LEDs illumination. The inventors do not exclude that further improvement of teeth whitening results could be achieved by specially formulated toothpaste. For example, the inventor used a custom made paste and obtained sufficient teeth whitening results.

Claims

CLAIMS:

1. A tissue whitening device comprising:

an applicator unit comprising: a treatment surface comprising a plurality of treatment sites, each of the treatment sites being configured such that, when the applicator unit is in operation during a whitening treatment procedure, the treatment site is in contact with a whitening substance to apply treatment to a respective tissue portion via the whitening substance; and an electrode assembly configured to create a plurality of electromagnetic field regions within a treatment zone in the vicinity of said treatment surface, such that, when the applicator unit is in operation, said plurality of treatment sites are located in said plurality of the electromagnetic field regions thereby affecting said whitening substance at said treatment sites; and

an electromagnetic power source being in signal communication with said electrode assembly and configured to generate activation signals to operate the electrode assembly to create the electromagnetic field regions in at least some of the treatment sites; wherein each of the activation signals has a predetermined time- frequency profile to thereby apply an alternating electromagnetic field of the predetermined profile to the respective treatment site.

2. The tissue whitening device of claim 1, wherein said electromagnetic power source comprises an electromagnetic signal generator for generating an alternating activation signal, and a control unit configured for modifying said activation signal by a predetermined control function to create said predetermined time-frequency profile of the activation signal.

3. The tissue whitening device of claim 1 or 2, wherein said applicator unit is configured to wrap a tissue region or organ undergoing whitening treatment procedure.

4. The tissue whitening device of any of the preceding claims, wherein at least some of said treatment sites comprise compartments configured to receive therein a whitening substance.

5. The tissue whitening device of claim 4, wherein said treatment sites are different from each other in at least one of the following: i) their shapes, ii) their volumes, and iii) their surface area facing the respective tissue portion undergoing the whitening treatment procedure.

6. The tissue whitening device of any one of claims 1 to 5, wherein said electrode assembly comprises a single electrode unit.

5 7. The tissue whitening device of any one of claims 1 to 5, wherein said electrode assembly comprises a plurality of spaced-apart electrode units.

8. The tissue whitening device of claim 7, wherein at least some of the plurality of electrode units are operated in bipolar configuration.

9. The tissue whitening device of claim 7, wherein at least one of the plurality of 10 electrode units is operated in monopolar configuration.

10. The tissue whitening device of any of claims 7 to 9, wherein said plurality of spaced-apart electrode units form a three-dimensional array of electrode units.

11. The tissue whitening device of any of claims 7 to 10, wherein said electromagnetic power source activates each of the electrode units by a respective

15 activation signal having a respective predetermined time-frequency profile.

12. The tissue whitening device of any of the preceding claims, wherein said electromagnetic power source is locatable in a unit separate from said applicator unit.

13. The tissue whitening device of any of the preceding claims, wherein said activation signal is an AC current.

20 14. The tissue whitening device of any of the preceding claims, wherein said electromagnetic power source comprises at least one of the following: a rechargeable battery, a single -use battery, a mobile phone, a tablet computer, and a laptop computer plus a DC to AC converter.

15. The tissue whitening device of any of claims 2 to 14, wherein said control unit 25 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.

16. The tissue whitening device of claim 15, wherein said control unit is configured to control said at least one treatment parameter or said at least one physical parameter of

30 the whitening substance.

17. The tissue whitening device of claim 15, wherein said treatment parameter comprises at least one of the following: treatment time, magnitude of the current, type of AC waveform, temperature of said tissue portion or of a tissue in the vicinity of the tissue portion, magnitude of the voltage, AC frequency, duty cycle of said current, and

5 change in color of said tissue.

18. The tissue whitening device of claim 17, wherein said treatment time is in a range from about O.OlOsec to about 30min.

19. The tissue whitening device of claim 17, wherein said AC frequency is in a range from about 300 kHz to about 40.0MHz.

10 20. The tissue whitening device of claim 17, wherein said AC frequency is in a range from about 1.0MHz to about 10.0MHz.

21. The tissue whitening device of claim 17, wherein said waveform has one of the following shapes: a sine wave, a square wave, a triangular wave, and a saw-tooth wave.

22. The tissue whitening device of claim 17, wherein said temperature is in a range 15 from about 39° C to about 48° C.

23. The tissue whitening device of any 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.

24. The tissue whitening device of claim 23, wherein said control unit is configured 20 to store at least one measurement by said at least one sensor.

25. The tissue whitening device of claim 15, 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

25 parameter.

26. The tissue whitening device of claim 25, wherein said feedback control is based on at least one of: the measurement, the change in measurement as a function of time, the difference between the measurement for one portion of the tissue and the measurement for another portion of the tissue, the difference between change in measurement for one portion of the tissue and the change in measurement for another portion of the tissue.

27. The tissue whitening device of claim 15, wherein said physical parameter is related to at least one of the following: the whitening substance, the applicator unit, at least one electrode unit, the tissue portion or a tissue in the vicinity of the tissue portion, tissue reflectivity, tissue impedance, tissue color, tissue temperature, applicator unit temperature, electrode unit temperature, whitening substance temperature, whitening substance impedance, current, and voltage.

28. The tissue whitening device of any of the preceding claims, wherein said electrode assembly is coupled to said whitening substance by one of the following: a capacitive coupling, and a conductive coupling.

29. The tissue whitening device of claim 28, wherein, for said capacitive coupling, said electrode assembly is covered by a non-conductive material.

30. The tissue whitening device of claim 29, wherein, for said capacitive coupling, said non-conductive material is of a thickness in a range from about 0.05mm to 0.2mm.

31. The tissue whitening device of claim 28, wherein, for said conductive coupling, at least one of the following holds true: (a) at least a portion of at least one surface of said electrode assembly is bare, at least a portion of said bare portion of said surface exposable to said whitening substance, and (b) at least a portion of at least one surface of said electrode assembly is covered by a conductive material.

32. The tissue whitening device of any of the preceding claims, wherein said applicator unit is either single -use or reusable.

33. The tissue whitening device of any of the preceding claims, wherein the location of said electrode assembly in said applicator unit is selected from one or more of the following: embedded in said applicator unit, on a surface of said applicator, and proud of the surface of said applicator.

34. The tissue whitening device of claim 32, wherein stiffness of said applicator unit is selected from at least one of the following: flexible, semi-rigid, and substantially rigid.

35. The tissue whitening device of claim 32, wherein said applicator unit comprises a biocompatible, nonconductive polymer selected from at least one of the following: silicone, a foam material, nylon, and PVC.

36. The tissue whitening device of any of the preceding claims, wherein said tissue 5 undergoing a whitening treatment is skin tissue.

37. The tissue whitening device of claim 36, wherein shape of said applicator unit comprises at least one of the following: a glove, a fingerless glove, a tube configured to fit a finger, a tube configured to fit a toe, a boot, a boot with integral toes, a mask configured to fit the face, a nose-cap configured to fit over the nose, a chin-cap to fit

10 over the chin, a cap to fit over the head, an ear-cap to fit over an ear, and a substantially flat band.

38. The tissue whitening device of claim 37, wherein said substantially flat band is configured to fit the forehead, the neck, the arm, the chest, the hips, the waist, the thigh, the knee, the calf, the ankle, the foot, a finger, a toe and any combination thereof.

15 39. The tissue whitening device of any of claims 36 to 38, wherein said applicator unit is retained in position by at least one of the following: a tie, a buckle, an elastic band, Velcro™, a clip, and a clip-on band.

40. The tissue whitening device of any of claims 36 to 39, wherein said whitening substance comprises at least one of the following: a regular, commercially available,

20 toothpaste; a regular, commercially available, whitening toothpaste; a commercially- available skin treatment material; a commercially-available skin whitening material, specially formulated skin whitening material, and skin tightening material.

41. The tissue whitening device of any of claims 1 to 35, wherein said tissue undergoing a whitening treatment is teeth tissue.

25 42. The tissue whitening device of claim 41, wherein said applicator unit is configured as a dental tray and each of said treatment sites is sized and shaped to enclose said whitening substance and at least one tooth.

43. The tissue whitening device of claim 41, wherein said applicator unit comprises one or more of the following: a biocompatible, nonconductive polymer; cardboard; and 30 molded paper pulp.

44. An applicator device, for use in a tissue whitening device, the applicator comprising: a treatment surface comprising a plurality of treatment sites, each of the treatment sites being configured such that, when the applicator is in operation during a whitening treatment procedure, the treatment site is in contact with a whitening 5 substance to apply treatment to a respective tissue portion via the whitening substance; and an electrode assembly configured to create an electromagnetic field within a treatment zone in the vicinity of said treatment surface, such that, when the applicator is in operation, the electromagnetic field is induced in at least said whitening substance at said treatment sites.

10 45. A method of tissue whitening comprising:

applying a layer of a whitening substance to at least one tissue portion; applying to said at least one tissue portion, covered by the layer of the whitening substance, an alternating electromagnetic field according to a predetermined activation function having one or more frequencies in a range from a few hundreds of kHz to a 15 few tens of MHz; and

maintaining the application of said alternating electric field for a predetermined duration of a treatment session, thereby whitening said at least one tissue portion.

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