Combined ultrasonic and electric muscle stimulation device, system and methods

Abstract

Techniques, system, applicator, and method, for body contouring, skin tightening, fat reduction, and / or muscle stimulation, utilizing a plurality of surface electrodes for application of electric stimulation through one or more pairs of the plurality of surface electrodes, a plurality of ultrasound-radiators arranged in one or more groups, wherein each group of the ultrasound-applicators is positioned along at least one of the surface electrodes and / or between two or more of the surface electrodes, and one or more cooling elements configured to regulate temperature of tissue situated under the applicator.

Description

[0001] COMBINED ULTRASONIC AND ELECTRIC MUSCLE STIMULATION DEVICE, SYSTEM AND METHODS

[0002] TECHNOLOGICAL FIELD

[0003] The present application is generally in the field of aesthetic treatment procedures and techniques, particularly useful for skin tightening, circumference reduction and the treatment of cellulite, all together known as body contouring.

[0004] BACKGROUND ART

[0005] References considered to be relevant as background to the presently disclosed subject matter are listed below:

[0006] [1] T. Paillard, "Neuromuscular or Sensory Electrical Stimulation for Reconditioning Motor Output and Postural Balance in Older Subjects?" , Front. Physiol., 12 January 2022.

[0007] [2] Lake, D. A. "Neuromuscular electrical stimulation. An overview and its application in the treatment of sports injuries" Sports Med. 13, 320-336, 1992.

[0008] Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.

[0009] BACKGROUND

[0010] This section intends to provide background information concerning the present application, which is not necessarily prior art.

[0011] The present disclosure generally relates to cosmetic / aesthetic body contouring techniques and instrumentations operating on subcutaneous body fat and skin, by delivery of heat energy into under-skin (subcutaneous) and skin tissue regions of a treated subject. Such body contouring techniques can be effectively used to break apart and remove subcutaneous fat deposits, and thus considered as non-invasive and safer alternatives to surgical fat removing procedures, such as liposuction.

[0012] There are two fat layers under the dermis and epidermis skin layers, of which the upper subcutaneous fat layer (hypodermis) contains fat cells in lobules held in connective tissue bundles (fibrous septa) connecting the dermis (the skin) and the superficial fascia. The superficial fascia (SF) is a fibrous (extracellular matrix - ECM) connective tissue passing through the subcutaneous fat tissue (SFT), that separates the superficial and deep fat layers. The SF is a tissue layer with a thickness of about 1 to 3 mm, present nearly over all body parts at about 2 mm to 20 mm beneath the dermis. The superficial fascia together with the septa which connect the SF and dermis hold together the fat structures located under the dermis by a fibrous septal connective tissue network that connects to the dermis and envelopes clusters of adipocyte cells.

[0013] Because the fascia does not stretch, the accumulation of fat in septal connective tissue chambers / lobes can cause cellulite in 80-90% of females. In cellulite there are skin surface irregularities, such as dimples and outward projections. The SF, fibrous septa and dermis, become loose overtime due to collagen fragmentation and matrix breakdown occurring with aging, leading to tissue sagging, wrinkles, cellulite and an uneven skin surface.

[0014] Cellulite is mainly a cosmetic problem which causes a lot of suffering due to the unattractive dimpled appearance of the skin.

[0015] Cellulite can be treated by two main mechanisms: Mechanical or chemical breakdown of the septa (e.g., subcision or massage) or by heating the subcutaneous fat tissue and dermis. Both lead to breakdown of collagen, and later on to new collagen formation. Heating also leads to shrinkage of collagen fibers and stimulation of new collagen production. This leads to skin tightening, resulting in a more even skin surface.

[0016] Another problem of cellulite is unwanted fat accumulations in different body areas, such as the abdomen, thighs, buttocks, arms and more. These fat accumulations are a major disturbance, and moreover, when they are accompanied by obesity, together they also pose multiple severe health risks such as cardiovascular and metabolic diseases.

[0017] Yet another problem associated with cellulite is sagging of the skin and subcutaneous fat tissue with aging. This leads to loose “hanging” wrinkly skin. The above problems are many times accompanied by sarcopenia, which is age-related progressive loss of muscle mass and strength.

[0018] Different treatments are available for the above problems. For example, different radiofrequency and ultrasound technologies have been used to either heat or mechanically treat the subcutaneous fat and the dermis. Lately, electric muscle stimulation (EMS) techniques, also called neuromuscular electrical stimulation (NMES), are used not only to treat degenerative muscle disease, but also to improve the appearance together with the improvement of general well-being and health due to an increased muscle mass and strength.

[0019] Mainly ultrasound and radiofrequency technologies can be used to apply controlled heating of deep tissue structures for reduction in subcutaneous fat layer by apoptosis (slow fat cell death), production of new collagen, refine wrinkles and rejuvenate the skin, resulting in tighter and young-looking tissue that improves the overall body shape e.g., within few months, without leaving surgical scars and without surgical complications or side effects. Accordingly, effective non-invasive body contouring can be achieved by heating of the dermis, the superficial subcutaneous fat tissue and its fibrous septa, and the fibrous superficial fascia thereunder.

[0020] For example, very high frequency US waves oscillate material particles as they pass through the tissue, thereby causing generation of heat, and density and pressure changes therein Ze., the ultrasound wave energy is transferred into thermal energy inside the tissues. The US waves cause the fat molecules to vibrate, which generates heat that can break down and dissolve the fat, resulting in compression within the fat enclosing capsules. Heating dermis and subcutaneous fat connective tissue to 40-55°C causes collagen shrinkage and stimulates production of new collagen, while heating the same tissue to above 55°C results in destruction of chemical bonds, collagen denaturation and more pronounced delayed skin tightening.

[0021] Electrical current stimulation applied to the under-skin tissue by electrodes placed on the skin, causes alternate muscle contractions leading gradually to an increased muscle tone and strength. For example, NMES is typically used to apply low-frequency electric stimulation signals above a defined motor threshold (i.e., a minimal stimulation intensity for involuntary non-controlled segmental movements) via surface electrodes placed over motor points of target muscle(s), in order to directly activate muscle fibres. NMES thus produces strong muscle contraction patterns, which are different from voluntary contractions. The main problem of this treatment is that it can provoke pain [2],

[0022] US Patent Publication No. 2018 / 369583 discloses a portable electronic pulse stimulator with integrated Ultrasound and TENSZEMS that includes a unit and an electrode pad. The unit includes IC board and housing; the IC board has an Ultrasound output module and a TENSZEMS output module; The electrode pad has Ultrasound therapy head and TENSZEMS electrode. The heating function can be added, and the heating intensity can be adjusted if needed. At the same time, remote control function can be added, meaning the electronic pulse stimulator can both receive, and send data. The unit can work independently and is portable.

[0023] US Patent Publication No. 2007 / 055154 discloses a treatment system and method for reducing body perimeter, primarily aimed at reducing cellulite and / or fat at a region of treatment. Ultrasound waves and pressure exertion are applied to the region of treatment, preferably simultaneously. The pressure exertion may include manual or mechanical massage, and / or electrical muscle stimulation. An optional ultrasonic transducer head is utilized to also apply pressure and massage. Preferable frequencies and intensities of the ultrasound and the stimulation are also provided. US Patent Publication No. 3,735,756 discloses a duplex electro-ultrasonic medical therapy apparatus comprising a pair of ultrasound generators connected to a common power source and keyed by a duplex keyer circuit, the output of which is connected to a transducer which converts the electrical oscillations into mechanical vibrations for application to the patient's body to administer the ultrasonic medical therapy treatment. The apparatus also comprises an integrated electrical pulse generator having outputs connected to a pair of conductive pads to supply electrical muscle stimulation to the patient's body simultaneously with the ultrasound treatment. The electrical pulse generator further serves as a driving function for the ultrasound duplex keyer circuit.

[0024] GENERAL DESCRIPTION

[0025] The present application provides aesthetic body contouring procedures, based on thermal tissue effects and electric muscle stimulation (EMS) muscle contractions, and instruments for heating the dermis and subcutaneous fat tissue and applying electric current stimulation to the underlying muscle tissue, for skin-tightening and body shaping. In a broad aspect there is provided an (e.g., automatically) adaptable personalized system for skin tightening and fat reduction treatments, comprising an adjustable applicator e.g., using an adjustable strap or sleeve structure) configured to fit an arrangement of one or more surface electrodes and an array of US -radiators arranged adjacent and / or between at least some of the electrodes, and having adaptive cooling components, for successive (or simultaneous) application of US and electric stimulations to tissue of a body portion of a treated subject. A control unit can be used to periodically or intermittently apply low frequency and / or RF electrical stimulation pulses to the tissue via one or more selected pairs of the electrodes of the adjustable applicator, before, after, or with some overlap with, application of US-stimulation applied by one or more of the US-radiators of the adjustable applicator.

[0026] The control unit can be configured to select one or more pairs of surface electrodes of the adjustable applicator for application of the low frequency and / or RF electrical stimulation pulses, and apply therethrough the low frequency and / or RF electrical stimulation electriccurrent stimulation pulses to a selected portion of the tissue situated beneath the adjustable applicator. The control unit can be further or alternatively configured to select one or more of the US radiators of the applicator for thereby applying US-stimulation to a selected portion of the tissue situated beneath the adjustable applicator, simultaneously, in between, or with partial overlap, with the application of the low frequency and / or RF electrical-current stimulation pulses. The control unit can be configured to set frequency, amplitude, duty cycle, and / or prioritization of applicator's elements selection, for application of the low frequency electriccurrent stimulation pulses, and / or of the RF electric-current stimulation pulses, and / or of the US-stimulation pulses.

[0027] One or more sensor elements are provided in some embodiments in the adjustable applicator for obtaining one or more skin and / or under-skin measures / conditions of the treated subject e.g., temperature and / or depths and / or thicknesses of (e.g., fat and fascia) tissue layers. The control unit can be configured to acquire measurement data of the treated body portion from the sensor elements, and based thereon determine operational parameters (e.g., amplitudes, frequency, duty-cycle, time duration, cooling power, and / or prioritization of applicator's elements selection) for controlled transmittal and deposition of energy emitted by the applicator into the target tissue in the treated body portion, while avoiding excess heating of the treated tissue. The control unit utilizes in some embodiments self-learning (e.g., artificial intelligence) algorithms configured to determine based on the measurement data received from the sensor elements, and accumulated treatment session results of past treatments, the operational parameters for the adjustable applicator and the cooling elements used therewith.

[0028] In one aspect there is provided a body contouring and / or skin tightening applicator comprising a plurality of surface electrodes for application of electric stimulation through one or more pairs of the plurality of surface electrodes, a plurality of ultrasound-radiators arranged in one or more groups, wherein each group of the ultrasound-applicators is arranged along one or more of the surface electrodes and / or positioned between two or more of the surface electrodes, and one or more cooling elements configured to regulate temperature of tissue situated under said applicator. The applicator can be configured to apply EMS or RF electricstimulations via selected one or more pairs of the surface electrodes simultaneously, in between, or with at least some overlap, with application of ultrasound-stimulations applied via one or more ultrasound-radiators selected from the plurality of ultrasound-radiators.

[0029] In possible embodiments the groups of the US-radiators are positioned between two or more short surface electrodes forming an applicator-block. The applicator can comprise two or more of the applicator-blocks arranged in a side-by-side conformation and having at least one long surface electrode position between each pair of adjacently located applicator-blocks.

[0030] In possible applications the groups of the US-radiators are positioned between two or more arch-shaped surface electrodes forming an applicator-sector. The applicator can comprise two or more of the applicator-sectors arranged in a side-by-side conformation and having at least one radial surface electrode position between each pair of adjacently located applicatorsectors e.g., to form a circular applicator structure. In a possible application the applicator comprises two lateral surface electrodes and a plurality of US-radiators arranged between the lateral surface electrodes. Optionally, the surface electrodes are configured for application of EMS and / or RF stimulations. The applicator can comprise six US-radiators arranged in two parallel columns between the lateral electrodes. The applicator can comprise a central surface electrode and two groups of the US- radiators arranged at opposite sides of the central surface electrode.

[0031] Optionally, the lateral and central electrodes are configured for application of EMS and / or RF stimulations. In a variant, each group of the US-radiators comprises three US- radiators. The lateral surface electrodes are configured in possible embodiments for application of the EMS-stimulations, and the central surface electrode is configured for application of the RF-stimulations together with a selected one of said lateral surface electrodes. The US- radiators can be configured to form a fluid channel for streaming a coolant through the applicator. Optionally, at least one of the surface electrodes is implemented by at least some portion of a support frame and / or housing of at least one of the US-radiators.

[0032] In another aspect there is provided a non-therapeutic, non-surgical method of body contouring and / or skin tightening. The method comprises fitting an applicator to a body portion of a treated subject, selecting one or more US-radiators of the applicator for thereby applying periodic or intermittent US-stimulation to underlying tissue structures, and selecting one or more pairs of surface electrodes of the applicator for thereby applying EMS and / or RF stimulation to the underlying tissue structures. The method can comprise selecting the one or more pairs of surface electrodes in a vicinity of the selected one or more US-radiators of the applicator. The method comprises in sone embodiments streaming a coolant through the US- radiators to prevent overheating of the stimulated tissue structures.

[0033] In yet another aspect there is provided a body contouring, skin tightening, fat reduction, and / or muscle stimulation, system comprising: one or more applicators according to any one of the embodiments disclosed herein; an EMS stimulator configured for application of EMS electric-stimulations via selected one or more pairs of the surface electrodes; a RF stimulator configured for application of RF electric-stimulations via selected one or more pairs of the surface electrodes; and an ultrasound (US) stimulator for application of ultrasound stimulations via selected one or more of the plurality of ultrasound-radiators.

[0034] The system comprises in some embodiments a control unit configured to operate the EMS, RF and US stimulators for application of the EMS and / or the RF electric-stimulations simultaneously, in between, or with at least some overlap, with application of the ultrasoundstimulations applied via the one or more ultrasound-radiators. One or more sensor elements can be used in the system to generate measurement data indicative of measures / conditions of skin and / or under-skin situated under the applicator. The control unit can be configured to process the measurement data from the one or more sensor elements, and determine based thereon at least one operational parameter of the EMS, RF and / or US stimulators.

[0035] The one or more sensor elements can comprise at least one temperature sensor and / or at least one deep tissue imaging sensor. The system can comprise image processing tools configured to determine parameters of tissue situated under the applicator based on measurement data from the deep tissue imaging sensor.

[0036] In some embodiments the system comprises a repository for storing a plurality treatment session data records of treatment sessions carried out by the system. The system can comprise an artificial intelligence module configured to process and analyze the plurality of treatment session data records stored in the repository and determine based thereon and based on the measurement data from the one or more sensor elements at least one operational parameter of the EMS, RF and / or US stimulators.

[0037] In yet another aspect there is provide a method of manufacture of a body contouring, skin tightening, fat reduction, and / or muscle stimulation, applicator. The method comprising determining a desired configuration and geometry of the applicator, preparing components of the applicator to achieve the desired configuration and geometry, where the components are configured to implement a plurality of surface electrodes and a plurality of US radiators of the applicator, forming electrical connectivity to PZ-transducer of each of said plurality of US radiators, attaching each of said PZ-transducers to a respective support or housing, attaching the plurality of surface electrodes and the support or housings of the US radiators to assemble the applicator of the desired geometry.

[0038] The method comprising in some embodiments attaching the plurality of surface electrodes and support or housings such that at least some of the PZ-transducers are arranged along at least one of the surface electrodes and / or between two or more of the surface electrodes. The determining of the desired configuration and geometry of the applicator can comprise determining number and / or geometry of the plurality of US -radiators, and / or of their support or housings , and of the plurality of surface electrodes.

[0039] The method can further comprise measuring resonance and / or impedance of each PZ- transducer while being attached to its support or housing, configuring a matching filter to each PZ-transducer based on the resonance and / or impedance measurement thereof, and electrically coupling the matching filters to their respective PZ-transducers. The method comprises in some embodiments coupling fluid inlet and outlet ports to the applicator for streaming a coolant therethrough. The method can also comprise electrically connecting an electric board of the applicator to each one of the plurality PZ-transducers and the plurality of surface electrodes. Optionally, the method comprising implementing at least one of the plurality of surface electrodes by at least some portion of the support or housing of at least one of the plurality of PZ-transducers.

[0040] The embodiments disclosed herein can be implemented in accordance with configuration and / or features disclosed in international patent publication No. WO 2020 / 121307 of the same coinventors hereof, and which is incorporated herein by reference.

[0041] BRIEF DESCRIPTION OF THE DRAWINGS

[0042] In order to understand the invention and to see 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. Features shown in the drawings are meant to be illustrative of only some embodiments of the invention, unless otherwise implicitly indicated. In the drawings like reference numerals are used to indicate corresponding parts, and in which:

[0043] Figs. 1A and IB schematically illustrates a body contouring system according to some possible embodiments, wherein Fig. 1A exemplifies the system utilizing a rectangular applicator and Fig. IB exemplifies the system utilizing a circular applicator;

[0044] Figs. 2A and Fig. 2B schematically illustrate specific implementations of the body contouring system according to some possible embodiments, wherein Fig. 2A exemplifies the system utilizing a rectangular applicator having two surface electrodes and a plurality of US- radiators and Fig. 2B exemplifies the system utilizing a rectangular applicator having three surface electrodes and a plurality of US -radiators;

[0045] Fig. 3 depicts a specific implementation of the applicator shown in Fig. 2A according to some possible embodiments;

[0046] Fig. 4 presents heat distribution obtained with a specific implementation of the applicator shown in Fig. 2B according to some possible embodiments;

[0047] Fig- 5 shows imaging of under skin tissue structures during body contouring procedures, and extraction of characteristic parameters therefrom according to some possible embodiments; and

[0048] Fig. 6 is a flowchart illustrating a process of manufacture of an applicator according to possible embodiments. DETAILED DESCRIPTION OF EMBODIMENTS

[0049] The subject matter disclosed herein generally pertains to body contouring techniques and instrumentations, configured to apply sequences of US and electric-current stimulations to under-skin tissue structures. One or more specific and / or alternative embodiments of the present disclosure will be described below with reference to the drawings, which are to be considered in all aspects as illustrative only and not restrictive in any manner. It shall be apparent to one skilled in the art that these embodiments may be practiced without such specific details. In an effort to provide a concise description of these embodiments, not all features or details of an actual implementation are described at length in the specification. Elements illustrated in the drawings are not necessarily to scale, or in correct proportional relationships, which are not critical. Emphasis instead being placed upon clearly illustrating the principles of the invention such that persons skilled in the art will be able to make the instrumentations and use the procedures, once they understand the principles of the subject matter disclosed herein. This subject matter may be however provided in other specific forms and embodiments without departing from the essential characteristics described herein.

[0050] The body contouring techniques and instrumentations disclosed herein are configured to schedule periodic or intermittent application of US and electric-current stimulations to under-skin tissue structures, for breaking, removing and / or flattening, under-skin fat deposits. A specially designed applicator, which can be configured to elastically / flexibly adjust and / or fit over a (e.g., curved) body portion of a treated subject, is utilized to selectively apply the US and electric-current stimulations over a certain tissue area and / or volume covered by the applicator, with a preferred / desirable distribution thereover, for pain relief and substantially even distribution of thermal and muscle contractions energy therewithin. The applicator embodiments disclosed herein can be similarly used to focus the application of the US and / or electric-current stimulations to a specific under-skin target tissue, and / or to tissue structures surrounding such under-skin target tissue, so as to restrict the stimulations being applied to a specific predefined area and / or volume of the underlying tissue.

[0051] The applicator of embodiments hereof generally comprises one or more groups of US- radiators, each group comprising at least one US-radiator, arranged along at least one surface electrode and or between at least two surface electrodes. In possible embodiments, each group of the US-radiators is surrounded by / located between two, or three, or four, or more, surface electrodes, or by at least some portion thereof. For example, such applicator configurations can be achieved utilizing rectangular or circular arrangements of the US-radiators and surface electrodes, or a combination thereof. Such applicator configurations can be used to periodically or intermittently apply EMS or RF electric-current stimulation(s) through one or more selected pairs of the surface electrodes, and to concurrently and periodically or intermittently apply the US-stimulation(s) through one or more US-radiators selected from the one or more groups (or form the same group) of US-radiators. Optionally, but in some embodiments preferably, the applicator is used to periodically or intermittently apply EMS electric-current stimulation through one or more selected pairs of the surface electrodes, apply the US-stimulation through one or more US-radiators selected from the one or more groups (or from the same group) of US-radiators, and to apply RF electric-current stimulation through one or more other (or the same) selected pairs of the surface electrodes.

[0052] In possible embodiments, a plurality of US-radiators of the applicator can be arranged in rectangular groups of one or more US-radiators located between two, or three, or four, or more, of the surface electrodes. Alternatively, in possible embodiments the US-radiators can be arranged in circular groups of US-radiators, each group comprising one or more concentric circular arrangements of the US-radiators located between one or more arch-shaped surface electrodes. In some embodiments such circular applicator arrangement further comprises surface electrodes radially extending from a central region of the applicator towards a circumference of the applicator. Optionally, a single central US-applicator is placed in the central region of the applicator, such that one or more surface electrodes can radially extend from the central region of the applicator ( / .< ., from the central US-applicator) towards the circumference of the applicator.

[0053] The US and electric-current stimulations can be applied to the underlying tissue in a predetermined order of stimulations, or as separate independent sequences, which may have some overlap therebetween, for periodic or intermittent application of low-frequency electriccurrent stimulations (also referred to herein as EMS stimulations), and / or US-stimulations, and / or high-frequency electrical-current stimulations (also referred to herein as radiofrequency - RF stimulations), in any suitable order, or concurrently with or without overlap, or in an unordered fashion.

[0054] Optionally, but in some embodiments preferably, one or more sensor elements are used e.g., in the applicator or externally, to provide data / signals indicative of skin and / or under-skin measures / conditions (temperature, deep tissue imaging). A control unit is used in some embodiments to determine operational parameters (e.g., amplitudes, frequencies, duty-cycles, prioritization of applicator's elements selection) for the EMS, US and / or RF, stimulations to be applied by the applicator, based at least in part on the measurement data / signals received from the one or more sensor elements.

[0055] For example, one or more cooling elements are provided in some embodiments in the applicator, and / or external thereto, and controllably operated during treatment procedures carried therewith, for regulating the temperature of the skin, and / or of the underlying tissue structures, to prevent overheating thereof. As another non-limiting example, tissue (e.g., US) imaging can be used in some embodiments in the applicator, and / or external to the applicator, to visualize the underlying tissue structures, determine depths and / or thicknesses of the underlying tissue structures, and determine based thereon operational parameters of the EMS, US and / or RF, stimulations to be applied by the applicator. Accordingly, the stimulation energy can be applied to specific region / area of the underlying tissue e.g., by selectively activating a subset of the plurality of US -radiators and a subset of the surface electrodes. This way, the electrical and US stimulations applied to the treated subject can be adjusted and optimized to suit a specific physiological profile of the treated subject, while focusing the applied stimulation onto a specific region of the underlying tissue, or evenly distributing it thereinside.

[0056] Alternatively, the intensities, duty cycles, and / or frequencies, of the stimulations applied by selected groups of the US-radiators and / or of the surface electrodes can be adjusted to geometrically shape the stimulations thereby applied towards a specific target underlying tissue regions / structures. For example, in possible embodiments the applied stimulations can be geometrically shaped such that high intensity stimulations are applied by the US-radiators and / or of the surface electrodes located substantially over the target underlying tissue regions / structures, and application of gradually decreasing stimulations by the US-radiators and / or of the surface electrodes surrounding the target underlying tissue regions / structures e.g., as a function of distance from the target tissue regions / structures.

[0057] For an overview of several example features, process stages, and principles of the invention, the applicators and their system examples, illustrated schematically and diagrammatically in the figures, are intended for body contouring procedures. These applicators / sy stems are shown as one example implementation that demonstrates a number of features, processes, and principles used to break, remove and / or flatten, fat from under-skin tissue structures, but they are also useful for other applications and can be made in different variations. Therefore, this description will proceed with reference to the shown examples, but with the understanding that the applicators / systems, and related techniques, recited in the claims below, can be also implemented in myriad other ways, once the principles are understood from the descriptions, explanations, and drawings herein. All such variations, as well as any other modifications apparent to one of ordinary skill in the art and useful in applications of US and electric-current stimulations, may be suitably employed, and are intended to fall within the scope of this disclosure.

[0058] Fig. 1A exemplifies a stimulation system 100 utilizing a rectangular applicator configuration 11, according to some possible embodiments. The system 100 generally comprises the rectangular applicator 11, having a plurality of rectangular-shaped groups 3u of US-radiators 13u, wherein each group 3u of the US-radiators 13 is arranged along at least one surface electrode le and / or between at least two surface electrodes le, a US-stimulator 13 configured to periodically or intermittently generate US-stimulation signals applied through one or more US-radiators 13u selected from the one or more groups 3u (or from the same group) of US-radiators 13u, and an electric stimulator 12' configured to periodically or intermittently generate electric-current stimulation signals applied through one or more pairs of surface electrodes le selected from the plurality of surface electrodes le of the applicator. Optionally, but in some embodiments preferably, the one or more pairs of surface electrodes le selected for application of the electric-current (e.g., EMS or RF) stimulation are located in the vicinity of the one or more US-radiators 13u selected for application of the US-stimulation.

[0059] In this non-limiting example, each rectangular group 3u of US-radiators 13u is surrounded by four surface electrodes le, or some portion thereof. Particularly, as seen, each rectangular group 3u of the US-radiators 13u can be located between a pair of short (e.g., horizontal) surface electrodes le having a length substantially of one side of the rectangular group 3u of the US-radiators 13u, and between a pair of long (e.g., vertical) surface electrodes having a length that is substantially greater than a side-length of the rectangular group 3u of the US-radiators 13u. One or more of the rectangular groups 3u of US-radiators 13u, with their short surface electrodes, can be sequentially (e.g., vertically) arranged along pairs of the long electrodes, such that each pair of adjacently located rectangular groups 3u of US-radiators 13u has at least one common short surface electrode thereby shared, so as to form an applicatorblock 11b of the rectangular groups 3u of US-radiators 13u and of the short and long surface electrodes le surrounding them. One or more of such applicator-blocks 11b can be arranged in a side-by-side conformation, such that each pair of adjacently located applicator-blocks 11b is sharing at least one long surface electrode, to thereby form a matrix of the US-radiators 13u and of the short and long surface electrodes le partitioning between the rectangular groups 3u of the US-radiators 13u.

[0060] The electric-stimulator 12' is configured in some embodiments to apply EMS stimulation via one or more of the short and / or long surface electrodes le of the applicator 11. The electric-stimulator 12' can be alternatively, or additionally, configured in some embodiments to apply FM stimulation via one or more of the short and / or long surface electrodes le of the applicator 11. Optionally, but in some embodiments preferably, the rectangular groups 3u of the US-radiators 13u and the plurality of surface electrodes le of the applicator 11 are arranged on an elastically adjustable mat or strap configured to allow effectively fitting them over a (e.g., curved) body part (e.g., belly, leg / thigh, hand) of a treated subject, or over a selected portion thereof. The applicator 11 can be attached to the treated body part by one or more retaining straps (not shown) e.g., utilizing Velcro and / or buckle retainer means.

[0061] Optionally, but in some embodiments preferably, the system 100 comprises a control unit 15 configured to communicate control / operational data / signals 13d for operation of the US-stimulator 13, and control / operational data / signals 12d for operation of the electricstimulator 12'. One or more sensor elements Ils can be used in (or external to) the applicator 11, for generation of measurement data / signals lid indicative of one or more skin and / or under-skin measures or conditions (e.g., temperature, thicknesses and / or depths of under-skin tissue structures) at the treated body part. The control unit 15 generally comprises one or more processors 15c and memories 15m, which can be configured to select one or more of the US- radiators 13u for application of the US-stimulation by the US-stimulator 13, and one or more pairs of the surface electrodes le for application of the electric-current stimulation by the electric-stimulator 12', and / or adjust and / or regulate the stimulations generated by the stimulators 13,12', at least partially based on the measurement data / signals lid generated by the one or more sensor elements Ils.

[0062] For example, in possible embodiments the control unit 15 comprises an electric stimulation module 15e configured and operable to generate the control data / signals 12d used for operating the electrical-stimulator 12'. The control unit 15 can further comprise a US- stimulation module 15u configured and operable to generate the control data / signals 13d used for operating the US-stimulator 13. Optionally, but in some embodiments preferably, a synchronization module 15s is used in the control unit 15 for scheduling and / or synchronizing the generation of the control data / signals 12d,13d by the electrical-current and the US stimulation modules 15e,15u, so as to schedule and / or synchronize the application of the US and electric-current stimulations by the applicator 11 accordingly. Additional modules (e.g., 15a and 15p shown in Figs. 2A and 2B) can be used for processing and analyzing the measurement data / signals lid from the one or more sensors Ils, and based thereon determine operational parameters for use by the electric-current and US stimulation modules 15e,15u in generation of the control data / signals 12d,13d.

[0063] Fig. IB exemplifies a stimulation system 100' utilizing a circular applicator configuration 11', according to some possible embodiments. The system 100' generally comprises the circular applicator 11', having a plurality of arch-shaped groups 3u' of US- radiators 13, wherein each arch-shaped group 3u' of the US-radiators 13 is arranged between at least two (short) arch-shaped surface electrodes le', a US-stimulator 13 configured to periodically or intermittently generate US-stimulation signals applied through one or more US- radiators 13u selected from the one or more groups 3u' (or from the same group) of US- radiators 13u, and an electric stimulator 12' configured to periodically or intermittently generate electric-current stimulation signals applied through one or more pairs of the archshaped surface electrodes le,le' selected from the plurality of surface electrodes le,le' of the circular applicator 100'.

[0064] In some embodiments the circular applicator 11' further comprises one or more (long) radial electrodes le radially extending from a central region of the circular applicator 100' towards a circumference thereof. Optionally, but in some embodiments preferably, the one or more pairs of surface electrodes le,le' selected for application of the electric-current stimulation are located in the vicinity of the one or more US-radiators 13u selected for application of the US-stimulation. The electric-current stimulator 12' is configured in some embodiments to apply EMS stimulation via one or more of the arch-shaped and / or long-radial surface electrodes of the applicator 11'. The electric-current stimulator 12' can be alternatively, or additionally, configured in some embodiments to apply FM stimulation via one or more of the arch-shaped le' and / or long-radial le surface electrodes of the applicator 11'.

[0065] In this non-limiting example, each arch-shaped group 3u' of the US-radiators 13u is surrounded by four surface electrodes le,le' or some portion thereof. Particularly, as seen, each arch-shaped group 3u' of the US-radiators 13u can be located between a pair of arch-shaped surface electrodes le', and between a pair of long radial surface electrodes. With this configuration a plurality of applicator-sectors 13b' can be arranged between adjacently located long-radial surface electrodes le, each applicator-sector 13b' comprising one or more of the arch-shaped groups 3u' of the US-radiators 13u, with their respective arch-shaped surface electrodes le', such that each pair of the adjacently located arch-shaped groups 3u' of US- radiators 13u has one or more common arch-shaped surface electrodes le' thereby shared.

[0066] Optionally, but in some embodiments preferably, the arch-shaped groups 3u' of the US- radiators 13u and the plurality of surface electrodes le,le' of the applicator 11' are arranged on an elastically adjustable mat or strap configured to allow effectively fitting them over a (e.g., curved) body part (e.g., belly, leg / thigh, hand) of a treated subject, or over a selected portion thereof. The applicator 11' can be attached to the treated body part by one or more retaining straps (not shown) e.g., utilizing Velcro and / or buckle retainer means.

[0067] Optionally, but in some embodiments preferably, the system 100' comprises a control unit 15 configured to communicate control / operational data / signals 13d, 12d for operation of the US and electric-current stimulators 13,12' as described hereinabove. One or more sensor elements Ils can be similarly used in (or external to) the applicator 11', for generation of measurement data / signals lid indicative of one or more skin and / or under-skin measures or conditions (e.g., temperature, thicknesses and / or depths of under-skin tissue structures) at the treated body part. The control unit 15 can similarly comprise an electric stimulation module 15e configured and operable to generate the control data / signals 12d used for operating the electric-current stimulator 12', and / or a US-stimulation module 15u configured and operable to generate the control data / signals 13d used for operating the US-stimulator 13, and / or a synchronization module 15s for scheduling and / or synchronizing the generation of the control data / signals 12d,13d by the electrical-current and the US stimulation modules 15e,15u. One or more additional modules (e.g., 15a and 15p shown in Figs. 2A and 2B) can be similarly used for processing and analyzing the measurement data / signals lid from the one or more sensors Ils, and based thereon determine operational parameters for use by the electric-current and US stimulation modules 15e,15u in generation of the control data / signals 12d,13d.

[0068] Fig. 2A schematically illustrates a stimulation system 10 utilizing a rectangular applicator 11* configuration, having two surface electrodes 12e and a plurality of US -radiators 13u arranged between the surface electrodes 12e. The US-radiators 13u can be arranged to form a matrix 13x structure having one or more rows and / or columns of the US-radiators 13u arranged between the surface electrodes 12e. The electric stimulator 12 of system 10 is accordingly configured to apply electric-current stimulations via a single pair of surface electrodes 12e, which may include EMS electric-current stimulations and / or RF electriccurrent stimulations.

[0069] For example, when used to apply the EMS electric-current stimulations, the electriccurrent stimulation generated by the electric stimulator 12 can be in a form of a train of electriccurrent pulses having pulses frequencies in the range of 3 to 150 Hz, or in the range of 3 to 200 Hz, ON / OFF duty-cycles in the range of 10 / 90% to 90 / 10%, and amplitudes in the range of 0 to 80 milliampere. Alternatively, or additionally, the electric stimulator 12 can be configured to apply RF electric-current stimulations via the electrodes 12e, which can be in a form of a train of electric-current pulses having a frequency in the range of 0.9 to 1.1 MHz, optionally about 1 MHz, ON / OFF duty-cycles in the range of 10 / 90% to 90 / 10%, and amplitudes in the range of 0 to 600 Milliamperes (e.g., on 200 ohm).

[0070] As in previously described embodiments, one or more sensor elements Ils can be used in (or external to) the applicator 11*, for generation of measurement data / signals lid indicative of one or more skin and / or under-skin measures or conditions (e.g., temperature, thicknesses and / or depths of under-skin tissue structures) at the treated body part. The control unit 15 can be similarly used to control and regulate the stimulations applied by the US and / or the electric stimulators 12,13. The control unit 15 can be configured to select one or more of the US- radiators 13u for periodic or intermittent application of the US-stimulation by the applicator 11*, and / or activate the electric-current stimulator 12 to apply periodic or intermittent EMS and / or RF electric-current stimulations via the surface electrodes 12e.

[0071] The control unit 15 can be configured to adjust and / or regulate the US and / or the electric-current stimulations generated by the stimulators 13,12, at least partially based on the measurement data / signals lid generated by the one or more sensor elements Ils. For this purpose, the control unit 15 can be similarly configured with an electric stimulation module 15e configured and operable to generate control data / signals 12d for operating the electriccurrent stimulator 12, and / or a US-stimulation module 15u configured and operable to generate control data / signals 13d used for operating the US-stimulator 13, and / or a synchronization module 15s for scheduling and / or synchronizing the generation of the control data / signals 12d,13d by the electrical-current and the US stimulation modules 15e,15u.

[0072] Optionally, but in some embodiments preferably, the control unit 15 comprises an analysis module 15a configure to receive and process the measurement data / signals lid generated by the one or more sensor elements Ils. A parameters determining nodule 15p can be used in the control unit 15 for determining, based on the analysis carried out by the analysis module 15a and / or the measurement data / signals lid from the one or more sensor elements Ils, operational parameters for use by the electric-current and US stimulation modules 15e,15u in generation of the control data / signals 12d,13d.

[0073] Fig. 2B schematically illustrates a stimulation system 10' utilizing a rectangular applicator 11Aconfiguration, having two lateral surface electrodes 12e, a central surface electrode 14e, and a plurality of US -radiators 13u arranged between the lateral and central surface electrodes 12e,14e. The US-radiators 13u can be arranged to form two matrix 13x' structures, each of which having one or more rows and / or columns of the US-radiators 13u arranged between one of the lateral surface electrodes 12e and the central surface electrode 14e

[0074] The system 10' is configured to use the lateral and central surface electrodes 12e,14e for application of EMS and / or RF electric current stimulations, simultaneously, in between, or with at least some overlap, with US-stimulations applied via one or more selected US-radiators 13u of the applicator 11A. The system 10' therefore comprises an EMS stimulator 12 connected to the lateral surface electrodes 12e for periodic or intermittent application of EMS electriccurrent stimulation therethrough simultaneously, in between, or with at least some overlap, with US-stimulations applied via one or more selected US-radiators 13u. The system 10' further comprises a RF stimulator 14 electrically connected to the lateral and central surface electrodes 12e,14e for periodic or intermittent application of RF electric-current stimulations through a pair of surface electrodes selected therefrom, simultaneously, in between, or with at least some overlap, with US-stimulations applied via one or more selected US-radiators 13u.

[0075] Accordingly, in this configuration the EMS stimulations are applied via the lateral surface electrodes 12e, and the RF stimulations are applied either via the lateral surface electrodes 12e, or via the central surface electrode 14e and a selected one of the lateral surface electrodes 12e. Optionally, but in some embodiments preferably, the RF stimulations are applied only via the central surface electrode 14e and a selected one of the lateral surface electrodes 12e. The US-stimulator 13 is configured to apply periodic or intermittent US- stimulations via one or more US-radiators 13u selected from one or both of the US-radiators matrix 13x' structures of the applicator 11A.

[0076] The EMS and / or RF electric-current stimulations generated by the electric stimulator 12 can be in a form of a train of electric-current pulses having the same frequencies, dutycycles and / or amplitudes as indicated hereinabove. The US-stimulations applied by the one or more selected US-radiators 13u in embodiments hereof can be also in a form of a train of US pulses having frequencies in the range of 6 to 11 MHz, alternatively in the range of 6 to 10 MHz, optionally about 8 MHz, ON / OFF duty-cycles in the range of 10 / 90% to 90 / 10%, and intensity up to 10W / cm2, alternatively up to 4W / cm2, optionally about 2-3W / cm2.

[0077] As in previously described embodiments, one or more sensor elements Ils can be used in (or external to) the applicator 11*, for generation of measurement data / signals lid indicative of one or more skin and / or under-skin measures or conditions (e.g., temperature, electrical conductivity, blood perfusion, thicknesses and / or depths of under-skin tissue structures) at the treated body part. Optionally, but in some embodiments preferably, one or more under-skin imaging units e.g., US imagers) 13i are used either in the applicator or external thereto 11* for visualizing underlying tissue structures and generating imagery measurement data / signals 13g indicative thereof.

[0078] The control unit 15 in embodiments hereof can be used to control and / or regulate the stimulations applied by the US and electric stimulators 12,13, at least partially based on the imagery measurement data / signals 13g from the one or more under-skin imaging units 13i and / or the measurement data / signals lid from the one or more sensor elements Ils. The control unit 15 can be configured to select one or more of the US-radiators 13u for periodic or intermittent application of the US-stimulation by the applicator 11*, and / or activate the electric-current stimulator 12 to apply periodic or intermittent EMS and / or RF electric-current stimulations via the surface electrodes 12e / 14e.

[0079] For this purpose, the control unit 15 can be similarly configured with an electric stimulation module 15e configured and operable to generate control data / signals 12d' for operating the electric-current stimulator 12, and / or a RF stimulation module 15r configured and operable to generate control data / signals 12d" for operating the RF stimulator 14, and / or a US-stimulation module 15u configured and operable to generate control data / signals 13d used for operating the US-stimulator 13, and / or a synchronization module 15s for scheduling and / or synchronizing the generation of the control data / signals 12d, 12d",13d by the electricalcurrent and the US stimulation modules 15e,15u.

[0080] The control unit 15 may comprise a communication interface (I / F) module 15f configured to communicate control and / or measurement data / signals, wirelessly and / or over data / signals wires, with the different stimulators 12,13,14 and / or sensor elements Ils, lid.

[0081] Optionally, but in some embodiments preferably, the control unit 15 comprises an analysis module 15a configured to receive and process the measurement data / signals lid generated by the one or more sensor elements Ils and / or the imagery measurement data / signals 13g generated by the one or more under-skin imaging units 13i. The processed data from the analysis module 15a can be displayed in a display device (e.g., LCD, VGA, LED or touch screen) 15y, with or without at least some portion of the measurement data / signals lid from the one or more sensor elements Ils and / or the imagery measurement data / signals 13g from the one or more under-skin imaging units 13i. A parameters determining module 15p can be used in the control unit 15 for determining, based on the analysis carried out by analysis module 15a, and / or the measurement data / signals lid from the one or more sensor elements Ils, and / or the imagery measurement data / signals 13g from the one or more under-skin imaging units 13i, operational parameters for use by the electric-current, RF and / or US stimulation modules 15e,15r,15u in generation of the control data / signals 12d',12d",13d. For example, in some embodiments the analysis module 15a is configured to receive and process the imagery measurement data / signals 13g generated by the one or more underskin imaging units 13i, and determine based thereon depths and / or thicknesses of underlying tissue structures, such as demonstrated in Fig. 5. The analysis module 15a can accordingly utilize image processing tools 15i configured to determine the thicknesses and / or depths of the dermis, superficial, and / or superficial facia, layers of the underlying tissue. Alternatively, the thicknesses and / or depths of the underlying tissue layers can be determined manually using a pointing device (e.g., mouse or touchscreen) to make visual annotations on the under-skin tissue structures visualized on the display 15y between the tissue layers presented therein, and determining based thereon by the control unit 15 the thicknesses and / or depths of the underlying tissue layers, and use the same by the parameters determining module 15p to determine operational parameters for use by the electric-current, RF and / or US stimulation modules 15e,15r,15u in generation of the control data / signals 12d',12d",13d.

[0082] Optionally, but in some embodiments preferably, an artificial intelligence (Al) module 15q is used in the control unit 15 to process and analyze a plurality treatment session data stored over time in the system e.g., in the memory 15m and / or a database 15d. The Al module 15q can be configured to determine the operational parameters for applying the EMS, RF and / or US, stimulations based at least partially on a plurality of treatment sessions data records accumulated in the system over time, and indicative of treatment protocols used in each treatment session, characterizing information of the treated subject (e.g., gender, weight, height, circumferences of one or more body parts, and suchlike), and the results obtained.

[0083] In embodiments hereof the operational parameters determined by the control unit 15 may aim to maximize depth of maximal energy deposition, and may include frequency of applied stimulation pulses, duty-cycle of applied stimulation pulses, time intervals of application of the stimulation pulses, and / or a desired cooling temperature. The duty-cycle determined by the control unit 15 may be indicative of "ON" and "OFF" time intervals of EMS, RF and / or US, stimulation pulses e.g., when applying said stimulations intermittently. In possible embodiments the duty-cycle determined by the control unit 15 may be indicative of "ON" time intervals of different subsequently applied stimulations e.g., when periodically applying the stimulations. For example, duty-cycle parameters determined by the control unit 15 may be indicative of a "ON" time intervals: T1 for applying EMS stimulation, and / or T2 for applying US stimulation, and / or T3 for applying FM stimulation, wherein two or more of these stimulations can be repeatedly and consecutively applied one after the other. The duty-cycle parameters determined by the control unit 15 may further comprise an "OFF" time parameter T4, designating a time interval after the Tl, T2 and T3, time intervals, in which stimulations are not applied by the system.

[0084] Optionally, but in some embodiments preferably, a continuous sequence of US- stimulation pulses are applied repeatedly throughout treatment sessions with certain ON / OFF duty-cycle (e.g., between 10 / 90% to 90 / 10%) and frequencies (e.g., between 6 to 10 MHz, or to 11 MHz) for breaking apart under-skin fat deposits, and a continuous sequence of EMS stimulation pulses are applied simultaneously, optionally with at least partial overlap with the US-stimulation pulses, with certain ON / OFF duty-cycle (e.g., between 10 / 90% to 90 / 10%), frequency (e.g, between 3 to 150 Hz, or to 200 Hz) and Amplitudes (e.g., between 0 to 80 milliampere), for alleviating and sedating the pain / discomfort caused due to the US-stimulation pulses. Optionally, but in some embodiments preferably, a sequence of RF-stimulation pulses is applied with certain Amplitude (e.g., between 0 to 600 milliampere) within time intervals in which the EMS-stimulation signals are not being applied z.e., during at least part of the "OFF" time of the EMS-stimulation signals, for tightening the underlying tissue.

[0085] Fig. 3 depicts a possible implementation 11% of the applicator 11* shown in Fig. 2A, comprising two lateral surface electrodes 12e, and six (6) US-radiators 13u arranged in two columns with three (3) US-radiators 13u in each column. The applicator 11* / 11% comprises in some embodiments fluid inlet / outlet ports 16c for streaming a coolant through the US- radiators 13u. As seen, two wires 12r can be used to connect the surface electrodes 12e to the electric-current stimulator (12). In some embodiments the US-radiators 13u are configured to form an internal fluid channel 16e for streaming a coolant through the applicator 11* / 11% e.g., by means of one or more cooling ribs 16,16f.

[0086] Fig. 4 depicts a possible implementation 11$ of the applicator 11Ashown in Fig. 2B, comprising two lateral surface electrodes 12e, a central surface electrode 14e, and six (6) US- radiators 13u arranged in two columns along opposite side of the central electrode 14e, with three (3) US-radiators 13u in each column. The applicator 11$ is used in some embodiments to apply EMS stimulations via the lateral surface electrodes 12e, and / or to apply RF stimulations via the central surface electrode 14e and a selected one of the lateral surface electrodes 12e. Accordingly, in possible embodiments the applicator 11$ is utilized to apply either EMS or RF stimulation simultaneously, before / after, or with at least some overlap with, a US-stimulation applied via selected one or more of the US-radiators 13u. Fig. 4 further depicts heat distribution achieved in the underlying tissue using the applicator 11$.

[0087] Fig. 6 is a flowchart illustrating a process 60 of manufacture of an applicator (e.g., 11) according to possible embodiments. The process 60 can be started in determining a desired applicator configuration (si), including determining number and geometry e.g., triangular, rectangular, polygonal, circular, arch-shaped, or suchlike) of the US-radiators (13u), EMS electrodes (12e) and / or RF electrodes (14e). The geometry of these components (i.e., electrodes and / or transducers) is determined in some embodiments to obtain a desired geometry of the applicator (11). After determining geometry and size (si) of the applicator (11) and / or its various components, these components and / or their supports / housings are prepared accordingly to achieve the desired geometries.

[0088] The piezo-transducer (PZ-transducer e.g., ceramic / PZT) of each US radiator (13u) can be then electrically coupled (s2) to a respective connector e.g., by welding connector wires to the PZ-transducer plate. Next, each piezo-transducer can be attached (s3) to a respective support element (also referred to as housing e.g., configured for acoustic impedance matching between the PZ-transducer plate and the tissue).

[0089] Optionally, but in some embodiments preferably, resonance and / or impedance of each PZ-transducer is then measured (s4), while being attached to its support. Thereafter, a matching filter is configured (s5) and electrically coupled to each PZ-transducer based on the resonance and / or impedance measurement thereof e.g., for impedance matching. The EMS and / or RF electrodes and supports of the PZ-transducers can be then connected to assemble (s6) the applicator (11) of the desired geometry e.g., such that at least some of the PZ-transducers are arranged along at least one of the electrodes and / or between two or more of the electrodes. Finally, inlet and outlet ports are connected (s7) to the applicator (11) and an electric board of the applicator is electrically connected to the PZ-transducers, and EMS and / or RF electrodes.

[0090] It is noted that in possible embodiments disclosed herein one or more (or all) of the EMS and / or RF electrodes can be implemented by the supports of the PZ-transducers, to achieve the desired geometry of the applicator, while reducing the number of, or eliminating, separately implemented electrodes.

[0091] Relative terms such as "lower," "upper," "horizontal," "vertical," "above," "below," "up," "down," "top" and "bottom", as well as derivatives thereof (e.g., "horizontally," "downwardly," "upwardly," etc.), and similar adjectives in relation to orientation of the described elements / components refer to the manner in which the illustrations are positioned on the paper, not as any limitation to the orientations in which these elements / components can be used in actual applications. It should also be understood that throughout this disclosure, where a process or method is shown or described, the steps / acts of the method may be performed in any order and / or simultaneously, and / or with other steps / acts not-illustrated / described herein, unless it is clear from the context that one step depends on another being performed first. In possible embodiments not all of the illustrated / described steps / acts are required to carry out the method.

[0092] As will be appreciated by one skilled in the art, aspects of the present invention may be embodied as a system, method or computer program product. Accordingly, aspects of the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment (including firmware, resident software, micro-code, etc.) or an embodiment combining software and hardware aspects that may all generally be referred to herein as a "circuit," "module" or "system." Furthermore, aspects of the present invention may take the form of a computer program product embodied in one or more computer readable medium(s) having computer readable program code embodied thereon.

[0093] For example, computer programs (e.g., computer control logic) may be loaded from a secondary memory into a main memory for execution by one or more processors of the control unit 15. Alternatively or additionally, computer programs may be received via a communication interface 15f. For instance, program code stored in a computer readable storage medium in a server data processing system may be downloaded over a network from the server to data processing system. The data processing system providing program code may be a server computer, a client computer, or some other device capable of storing and transmitting program code. Such computer programs, when executed, enable the computer system to perform certain features of the present invention as discussed herein. In particular, the computer programs, when executed, enable a control processor to perform and / or cause the performance of features of the present invention. Accordingly, such computer programs may implement controllers of the computer system. The processor generally serves to execute software instructions that may be loaded into a memory. The processor may be a number of processors, a multi-processor core, or some other type of processor, depending on the particular implementation.

[0094] As described hereinabove and shown in the associated figures, the present invention provides stimulation applicators and systems for body contouring and / or skin tightening, and related methods. While particular embodiments of the invention have been described, it will be understood, however, that the invention is not limited thereto, since modifications may be made by those skilled in the art, particularly in light of the foregoing teachings. As will be appreciated by the skilled person, the invention can be carried out in a great variety of ways, employing more than one technique from those described above, all without exceeding the scope of the claims.

Claims

CLAIMS:

1. A body contouring, skin tightening, fat reduction, and / or muscle stimulation, applicator, comprising: a plurality of surface electrodes for application of electric stimulation through one or more pairs of said plurality of surface electrodes; a plurality of ultrasound-radiators arranged in one or more groups, wherein each group of said ultrasound-applicators is positioned along at least one of said surface electrodes and / or between two or more of said surface electrodes; and one or more cooling elements configured to regulate temperature of tissue situated under said applicator.

2. The applicator of claim 1 configured to apply EMS or RF electric-stimulations via selected one or more pairs of the surface electrodes simultaneously, in between, or with at least some overlap, with application of ultrasound-stimulations applied via one or more ultrasoundradiators selected from the plurality of ultrasound-radiators.

3. The applicator of claim 1 or 2 wherein groups of the US-radiators are positioned between two or more short surface electrodes forming an applicator-block.

4. The applicator of claim 3 comprising two or more of the applicator-blocks arranged in a side-by-side conformation and having at least one long surface electrode position between each pair of adjacently located applicator-blocks.

5. The applicator of claim 1 or 2 wherein groups of the US-radiators are positioned between two or more arch-shaped surface electrodes forming an applicator-sector.

6. The applicator of claim 5 comprising two or more of the applicator-sectors arranged in a side-by-side conformation and having at least one radial surface electrode position between each pair of adjacently located applicator-sectors, so as to form a circular applicator structure.

7. The applicator of claim 1 or 2 comprising two lateral surface electrodes and a plurality of US-radiators arranged between said lateral surface electrodes, wherein said surface electrodes are configured for application of EMS or RF stimulations.

8. The applicator of claim 7 comprising six US-radiators arranged in two parallel columns between the lateral electrodes.

9. The applicator of claim 7 comprising a central surface electrode and two groups of the US-radiators arranged at opposite sides of said central surface electrode, wherein the lateral and central electrodes are configured for application of EMS and RF stimulations.

10. The applicator of claim 9 wherein each group of the US-radiators comprises three US- radiators.

11. The applicator of claim 9 or 10 wherein the lateral surface electrodes are configured for application of the EMS-stimulations and the central surface electrode is configured for application of the RF-stimulations together with a selected one of said lateral surface electrodes.

12. The applicator of any one of the preceding claims wherein the US-radiators are configured to form a fluid channel for streaming a coolant through the applicator.

13. The applicator of any one of the preceding claims wherein at least one of the surface electrodes is implemented by at least some portion of a support frame and / or housing of one of said US-radiators.

14. A non-therapeutic, non-surgical method of skin tightening, fat reduction, and / or muscle stimulation, the method comprising fitting an applicator to a body portion of a treated subject, selecting one or more US-radiators of said applicator for thereby applying periodic or intermittent US-stimulation to underlying tissue structures, and selecting one or more pairs of surface electrodes of said applicator for thereby applying EMS or RF stimulation to the underlying tissue structures.

15. The method of claim 14 comprising selecting the one or more pairs of surface electrodes in a vicinity of the selected one or more US-radiators of the applicator.

16. The method of claim 14 or 15 comprising streaming a coolant through the US-radiators to prevent overheating of the stimulated tissue structures.

17. A body contouring, skin tightening, fat reduction, and / or muscle stimulation, system comprising: one or more applicators according to any one of claims 1 to 13; a EMS stimulator configured for application of EMS electric-stimulations via selected one or more pairs of the surface electrodes; a RF stimulator configured for application of RF electric-stimulations via selected one or more pairs of said surface electrodes; and an ultrasound (US) stimulator for application of ultrasound stimulations via selected one or more of the plurality of ultrasoundradiators.

18. The system of claim 17 comprising a control unit configured to operate the EMS, RF and US stimulators for application of the EMS and / or the RF electric-stimulations simultaneously, in between, or with at least some overlap, with application of the ultrasoundstimulations applied via the one or more ultrasound-radiators.

19. The system of claim 17 or 18 comprising one or more sensor elements configured to generate measurement data indicative of measures / conditions of skin and / or under-skinsituated under the applicator, and wherein the control unit is configured to process said measurement data from said one or more sensor elements, and determine based thereon at least one operational parameter of the EMS, RF and / or US stimulators.

20. The system of claim 19 wherein the one or more sensor elements comprises at least one temperature sensor.

21. The system of any one of claims 17 to 19 wherein the one or more sensor elements comprises at least one deep tissue imaging sensor.

22. The system of claim 21 comprising image processing tools configured to determine parameters of tissue situated under the applicator.

23. The system of any one of claims 17 to 22 comprising a repository for storing a plurality treatment session data records of treatment sessions carried out by the system.

24. The system of claim 23 comprising an artificial intelligence module configured to process and analyze the plurality of treatment session data records stored in the repository and determine based thereon and based on the measurement data from the one or more sensor elements at least one operational parameter of the EMS, RF and / or US stimulators.

25. A method of manufacture of a body contouring, skin tightening, fat reduction, and / or muscle stimulation, applicator, the method comprising: determining a desired configuration and geometry of the applicator; preparing components of said applicator to achieve the desired configuration and geometry, said components configured to implement a plurality of surface electrodes and a plurality of US radiators of said applicator; forming electrical connectivity to PZ-transducer of each of said plurality of US radiators; attaching each of said PZ-transducers to a respective support or housing; attaching said plurality of surface electrodes and said supports or housings of the US radiators to assemble the applicator of the desired geometry such that at least some of the US radiators are arranged along at least one of the surface electrodes and / or between two or more of the surface electrodes.

26. The method of claims 25 wherein the determining of the desired configuration and geometry of the applicator comprises determining number and geometry of the plurality of US- radiators, and / or of their supports or housings, and of the plurality of surface electrodes.

27. The method of claim 25 or 26 comprising measuring resonance and / or impedance of each PZ-transducer while being attached to its support or housing, configuring a matching filterto each PZ-transducer based on the resonance and / or impedance measurement thereof, and electrically coupling the matching filters to their respective PZ-transducers.

28. The method of any one of claims 25 to 27 comprising coupling fluid inlet and outlet ports to the applicator for streaming a coolant therethrough.

29. The method of any one of claims 25 to 28 comprising electrically connecting an electric board of the applicator to each one of the plurality US radiators and the plurality of surface electrodes.

30. The method of any one of claims 25 to 29 comprising implementing at least one of the plurality of surface electrodes by at least some portion of the support or housing of at least one of the plurality of US radiators.

Images