Patent Application
20220062660
The invention is in the field of skin tightening systems and methods, in particular to those applying ultrasonic energy to the skin and sub-cutaneous tissue thereof.
Non-invasive body contouring and tissue tightening by energy-based devices (EBDs) have gained popularity in recent years and form now the largest segment in the aesthetic market.
US 2001/0014819 A1 discloses devices, methods, and systems for shrinking of collagenated tissues, particularly for treating urinary incontinence in a noninvasive manner by directing energy to a patient's own support tissues. This energy heats fascia and other collagenated support tissues, causing them to contract. The energy can be applied intermittently, often between a pair of large plate electrodes having cooled flat electrode surfaces, the electrodes optionally being supported by a clamp structure. Such cooled plate electrodes are capable of directing electrical energy through an intermediate tissue and into fascia while the cooled electrode surface prevents injury to the intermediate tissue, particularly where the electrode surfaces are cooled before, during, and after an intermittent heating cycle. Ideally, the plate electrode comprises an electrode array including discrete electrode surface segments so that the current flux can be varied to selectively target the fascia.
US 2018/0130457 discloses an ultrasound array comprising a plurality of ultrasound transducer elements on a carrier, the carrier further carrying an actuator arrangement of a material having an adjustable shape in response to an electromagnetic stimulus. e.g. an electro active polymer or optically responsive polymer, wherein tile material is arranged to change the orientation of said ultrasound transducer elements in response to said stimulus. This facilitates configurable beam shaping and/or body contour matching with the ultrasound array. An ultrasound system composing such an ultrasound array is also disclosed.
U.S. Pat. No. 10,292,859 discloses a cooling device for removing heat from subcutaneous lipid-rich cells of a subject having skin. The cooling device includes a plurality of cooling elements movable relative to each other to conform to the contours of the subject's skin. The cooling elements have a plurality of controllable thermoelectric coolers. The cooling elements can be controlled to provide a time-varying cooling profile in a predetermined sequence, can be controlled to provide a spatial cooling profile in a selected pattern, or can be adjusted to maintain constant process parameters, or can be controlled to provide a combination thereof.
U.S. Pat. No. 8,915,948 discloses a method and apparatus for treating tissue in a region at depth by applying optical radiation thereto of a wavelength able to reach the depth of the region and of a selected relatively low power for a duration sufficient for the radiation to effect the desired treatment while concurrently cooling tissue above the selected region to protect such tissue. Treatment may be enhanced by applying mechanical, acoustic or electrical stimulation to the region.
U.S. Pat. No. 10,265,550 discloses a probe for ultrasound treatment of skin laxity. Systems and methods can include ultrasound imaging of the region of interest for localization of the treatment area, delivering ultrasound energy at a depth and pattern to achieve the desired therapeutic effects, and/or monitoring the treatment area to assess the results and/or provide feedback. In an embodiment, a treatment system and method can be configured for producing arrays of sub-millimeter and larger zones of thermal ablation to treat the epidermal, superficial dermal, mid-dermal or deep dermal components of tissue.
U.S. Pat. No. 9,108,037 B2 discloses a tissue ablation system that facilitates lesioning deep tissue while preventing damage to superficial tissue and includes a probe having a distal end portion, at least one transducer carried on the distal end portion, and at least one acoustically transparent heat removal element thermally coupled to a target tissue within the beam path of the transducer. The transducer delivers acoustic energy to the tissue through the heat removal element in order to ablate the tissue; the heat removal element removes sufficient thermal energy from the tissue volume to prevent thermal necrosis in superficial tissue. The heat removal element may be a heat sink or a convective element. An optional temperature sensor provides advisory data to a practitioner and/or is coupled to a feedback control system operable to control delivery of acoustic energy to the tissue and/or a rate of thermal energy removal therefrom.
Novel and inventive features of the present invention advance the field of systems for skin-tightening and body shaping, as described below.
The main emphasis in the development of tissue tightening systems has been on the dermis. The present invention arises in part from an understanding that not only the dermis but also the subcutaneous fat tissue has to be tightened to achieve optimal tightening and contouring results.
Tissue tightening can be achieved by heating the dermis and the fibroseptal network in the subcutaneous fat tissue. This heating leads to shrinkage of collagen and to stimulation of new collagen production and thus tissue tightening. Heating the connective tissue in the dermis and in the subcutaneous fat to 40-55° C. induces collagen shrinkage and partially reversible damage with stimulation of new collagen production. Heating to above 55° C. causes destruction of chemical bonds, immediate collagen denaturation and immediate and delayed skin tightening. Tightening of skin and underlying tissue leads to tighter, younger-looking tissue.
Moreover it has been shown in multiple in-vitro studies (e.g., “Hyperthermic injury to adipocyte cells by selective heating of subcutaneous fat with a novel radiofrequency device: Feasibility studies”; Franco W et al.; Lasers Surg Med 2010; 42(5):361-370) that adipocytes are heat sensitive and that heating fat tissue for a certain time to up to 50° C. induces fat cell apoptosis or delayed adipocyte cell death. Heating fat for three minutes at 45° C. induces apoptosis in 60% of cells; heating for 1 minute at 50° C. induces apoptosis in 80% of cells; and 15 minutes at 43-45° C. leads to 80% apoptosis. This controlled heating later leads to a reduction of the subcutaneous fat layer together with new collagen production and thus an improved body shape.
Up to now, little to no attention has been paid to the superficial fascia (SF). SF passes as a sheet of fibrous connective tissue composed of extracellular matrix (ECM) through the subcutaneous fat tissue (SFT) and separates the superficial fat layer from the deep fat layer. It holds together the structures underneath and is connected to the dermis by a fibrous septal connective tissue network that envelopes clusters of adipocyte cells. The SF is present nearly everywhere in the body; it is 1-3 mm thick and is at a depth between 3.5 mm and 2 mm beneath the skin's outside surface, the depth depending on body area, sex, age, and BMI.
The superficial fascia, together with the fibrous septa and the dermis, loosen with age due to collagen fragmentation and matrix breakdown. This leads to tissue sagging, wrinkles, uneven skin surface and cellulite.
To be able to achieve the most effective non-invasive body contouring, it is important therefore to address all layers involved in the pathology of tissue. Not only the skin and the superficial subcutaneous fat tissue with its fibrous septa should be treated, but also the fibrous superficial fascia underneath.
Multiple EBDs on the market are for body contouring. Some are radio-frequency or ultrasound based devices and exert their effect on the tissue by heating. Other devices cool the fat tissue and induce fat cell death and thus circumference reduction by cooling.
Most existing devices either tighten the skin (mainly RF- and ultrasound-based devices) or reduce the circumference (cooling devices, ultrasound, RF, or laser). However, using generally available devices it is not possible to achieve both tightening and body contouring in the same device and thus multiple devices and combinations of different treatments are needed to achieve the desired results.
For some of the devices a well-trained technician and multiple and long treatments are needed to achieve the desired results. As large areas of the body need to be covered, the treatment may be very long (lasting up to a few hours) and results may depend on the professionalism of the technician sliding a movable energy source, e.g. a wand, over the skin. Thus, these treatments are expensive (taking into account treatment time and consumables) and results may be variable and vary greatly from clinic to clinic.
Lately, hands free devices—mostly cooling devices and some heating devices—for circumference reduction have taken up a large segment of the market. Their results are easier to reproduce than for the hand-moved ones, as their use is less technician dependent.
Most technologies do not provide visualization of tissue before or during treatment, so it is not exactly clear at which depth the treatment should be performed (e.g. the superficial fascia depth is different from person to person) and which exactly what layers have been treated. Thus many technologies are not effective as they do not treat tissue at the correct depth. A few technologies do have visualization by ultrasound of the treated area (as disclosed in U.S. Pat. No. 10,265,550) but due to limited energy penetration depth cannot reach the needed depth to treat superficial fascia.
There is a need for a tissue tightening and body-contouring device; which diagnoses the treatment layer at the correct depth; which addresses both circumference reduction and tissue tightening in one device; which provides the operator with visualization of the treatment; and which is easy to operate, is hands free, and can offer marked results after only one or two treatment sessions.
The suggested invention offers a solution that is efficacious for both skin laxity (at treatment depths of 3-20 mm) and fat deposits (at treatment depths of 10-30 mm). It offers a hands-free, thermal based solution for heating the subcutaneous fat and fascia while keeping the epidermis cooled with a temperature below the level of causing damage.
It is therefore within the scope of the invention to provide a system for ultrasonic skin-tightening and body shaping treatment, comprising
a. a sleeve configured for fixedly wrapping around an organ of a mammalian body; the organ comprising a treated volume of a layer of tissue(s) underneath an area of skin surface of the organ;
b. an arrangement of one or more treatment panels disposed on an inside surface of the sleeve, each the treatment panel comprising
c. a control module, in electrical connection with the treatment panels, configured to receive temperature outputs of the temperature sensors and to control the ultrasonic elements—including intensity, frequency, and/or duty cycle of the ultrasound waves—and to control the cooling plate temperature;
wherein the control module is further configured to control the ultrasonic elements and the cooling plates of each the treatment panel independently, thereby enabling hands-free treatment, with localized variations in the controls as needed, throughout the treatment volume.
It is further within the scope of the invention to provide the abovementioned system, wherein one or more of the treatment panels comprises a temperature sensor configured to monitor temperature on an outside surface of the treated volume portion.
It is further within the scope of the invention to provide any of the abovementioned systems, wherein the controller is further configured to receive one or more of preliminary inputs from the user according to anatomical area and size of patient.
It is further within the scope of the invention to provide any of the abovementioned systems, wherein the sleeve comprises a wrap-around cuff or a closed elastic loop.
It is further within the scope of the invention to provide any of the abovementioned systems, wherein the sleeve is configured for wrapping around one or more of an arm, the neck, the abdomen, the back, a thigh, and the face.
It is further within the scope of the invention to provide any of the abovementioned systems, wherein the treatment panels are arranged on the sleeve inside surface in one dimension, in two dimensions, or any combination thereof.
It is further within the scope of the invention to provide any of the abovementioned systems, wherein the treatment panels cover a portion of skin underneath the sleeve.
It is further within the scope of the invention to provide any of the abovementioned systems, wherein the control module is configurable to disable one or more of the treatment panels during any time interval of the treatment.
It is further within the scope of the invention to provide any of the abovementioned systems, wherein the control module is further configured to change of ultrasound parameters to change from skin tightening to fat destruction.
It is further within the scope of the invention to provide any of the abovementioned systems, further comprising a tether providing electrical connections to the ultrasonic elements and the cooling plate from the control module.
It is further within the scope of the invention to provide any of the abovementioned systems, wherein a treatment depth, in a portion of the treatment volume underneath one or more of the treatment panels, is controlled by varying one or more of the intensity, frequency, and temperature.
It is further within the scope of the invention to provide any of the abovementioned systems, wherein the system is configured for treatment of skin laxity, wherein the depth is 3-20 mm, and of fat deposits, wherein the depth is 10-30 mm.
It is further within the scope of the invention to provide any of the abovementioned systems, further comprising ultrasound imaging transducers, the system further configured to
a. acquire real-time ultrasound images of the treatment volume before, during, and/or after the treatment;
b. analyze the images during treatment to determine cumulative effects of the treatment at varying depths of the treatment volume; and
c. adjust the treatment parameters in real time as a function of the cumulative effects.
It is further within the scope of the invention to provide the previous system, wherein the control module is configured to employ a neural network algorithm to compute the depth indication.
It is further within the scope of the invention to provide any of the abovementioned systems including ultrasound image transducers, wherein the system is further configured to determine a depth of treatment prior to the treatment.
It is further within the scope of the invention to provide any of the abovementioned systems including ultrasound image transducers, wherein the control module comprises a user interface that displays the real-time image and/or the depth indication.
It is further within the scope of the invention to provide a method for providing real-time in-treatment depth indications from ultrasound images of a treatment volume, comprising steps of
a. obtaining any of the abovementioned systems;
b. acquiring training images taken during treatments by the system;
c. annotating the training images with observed depths of treatment;
d. processing an aggregation of the annotated images to develop a neural network algorithm for indicating treatment depth as a function of an ultrasound image 520;
e. deploying the neural network algorithm to indicate a treatment depth in a depth-monitoring image taken during a treatment 525.
Examples illustrative of embodiments of the disclosure are described below with reference to figures attached hereto. Dimensions of components and features shown in the figures are generally chosen for convenience and clarity of presentation and are not necessarily shown to scale. Many of the figures presented are in the form of schematic illustrations and, as such, certain elements may be drawn greatly simplified or not-to-scale, for illustrative clarity. The figures are not intended to be production drawings.
The present invention provides a novel system for skin tightening as described herein in detail.
Although various features of the disclosure may be described in the context of a single embodiment, the features may also be provided separately or in any suitable combination. Conversely, although the disclosure may be described herein in the context of separate embodiments for clarity, the disclosure may also be implemented in a single embodiment. Furthermore, it should be understood that the disclosure can be carried out or practiced in various ways, and that the disclosure can be implemented in embodiments other than the exemplary ones described herein. The descriptions, examples, and materials presented in herein should not be construed as limiting, but rather as illustrative.
The terms “treated volume” and “treatment volume” refer to a layer of tissue(s) underneath an area of skin surface that is to be treated with ultrasound.
The term “treatment volume portion” refers to some portion of the treatment volume, comprising tissue(s) underneath a particular area of the skin surface and/or at a particular depth beneath the skin surface.
The term “treatment surface” refers to the most superficial layer of a treatment volume, namely the epidermis. It may also refer to the portion of the epidermis on which a treatment panel of the invention is placed during treatment.
Reference is now made to
Apparatus 100 comprises a flexible or elastic sleeve 110, which can be a wrap-around cuff (similar to one used for a blood-pressure measurement apparatus). The wrap-around cuff may be secured by Velcro pads, snaps, laces, or adhesive tape. Alternatively, sleeve 110 can be a closed elastic loop or any flexible wrapping that can be fixedly wrapped around a treated volume of a patient. Sleeve 110 may be configured for wrapping around a treatment volume comprising any of one or more parts of the body, such as an arm, the neck, the abdomen, the back, a thigh, and any other anatomical areas that can be wrapped around. In some embodiments, a flexible mask is used for treatment of the face.
One or more treatment panels 120 are fixedly arranged on the surface of sleeve 110. Treatment panels 120 provide ultrasonic energy and heat removal (cooling) to the treatment volume, as further described herein. Treatment panels 120 face the inside of the sleeve 110, so as to provide ultrasonic and cooling treatment to the treatment volume. Treatment panels 120 may be secured to the inside of the sleeve 110. Alternatively, or in addition, treatment panels 120 may be secured to edges of openings in sleeve, for example, by stitching or fasteners.
As an alternative to a panel structure, one or more of the treatment elements providing ultrasound and cooling functions may have a cylindrical cross section.
A tether 130 connects treatment panels 120 to a control module (not shown). The control module provides driving power and signals to treatment panels 120. Alternatively, in some embodiments patient-connected apparatus 100 is wirelessly connected to the control module, whereby a power source and driving electronics are within patient-connected apparatus 100 and control signals are communicated wirelessly from the control module to treatment panels 120.
In some embodiments, the control module controls treatment parameters of ultrasonic energy and/or heat removal independently for each treatment panel 120. Ultrasonic energy parameters comprise ultrasonic intensity, frequency, and duty cycle. Heat removal parameters comprise surface temperature. By independent control of treatment parameters of each treatment panel, treatment may thereby be customized locally to different portions of the treatment volume underneath each treatment panel, depending on treatment requirements of each portion.
In some embodiments, patient-attached apparatus 100 further comprises one or more types of light-emitting therapy devices, such as low-level laser therapy (LLLT), laser skin resurfacing, LED light therapy, and combinations thereof. Preferably, these additional elements are also fixedly arranged on the inside wall of sleeve 110.
Reference is now made to
Besides ultrasound intensity, frequency of ultrasound emitted by ultrasonic element 120U may be varied to affect treatment depth. For example, lower ultrasonic frequencies can be used for deeper treatment and higher ultrasonic frequencies for shallower treatment; because the higher frequencies undergo higher attenuation and are converted to heat more superficially than the lower frequencies. Additionally, duty cycle of the ultrasonic energy may be varied; i.e., reduced to prevent heat build-up in portions of the treatment volume requiring high-intensity ultrasound treatment.
Reference is now made to
Ultrasonic element 120U is composed of a piezoelectric layer 170. Piezoelectric layer 170 is composed of a piezoelectric material such as lead zirconate titanate (PZT) or a composite material. Ultrasonic element 120U further comprises two conductive plates 180 and 190. Conductive plates 180 and 190 are connected through wires 150 to an alternating-current power source, which can be disposed in a control module (not shown). One of the conductive plates 190 is connected to electrical ground 200. To meet regulatory safety requirements, grounded conductive plate 190 is usually in electrical connectivity with the body.
Conductive plate 190 is connected to a cooling device 120C, in order to keep the skin surface temperature at a requisite temperature. The requisite temperature is below a level that damages the skin. Typically, the requisite temperature is less than about 40° C. Adjacent to conductive plate 190 there may be one or more temperature sensors 210. Alternatively, or in addition, temperature sensor(s) 210 may be located within cooling device 210. Each temperature sensor 210 is wired to the control module through tether 130. Temperature sensor 210 monitors the skin temperature, by measuring either heat conduction or infrared radiation from the skin surface. Readings of temperature from temperature sensor 210 enable closed-loop control of ultrasonic element 120U and cooling plate 120C, in order to maintain the requisite skin temperature.
Each treatment panel's 120 parameters of ultrasound (intensity, frequency, and duty cycle) and of cooling (skin surface temperature) may be independently controlled, including stopping of treatment altogether. Additionally, the parameters may be time-varied, either in predetermined temporal profiles or in response to feedbacks measured during a treatment.
Reference is now made to
Reference is now made to
After obtaining a system of the invention 505, including ultrasound imaging capability, an aggregation of ultrasound training images are acquired during treatments 510. The training images are annotated (e.g., by an ultrasound specialist) with observed depths of treatment 515. The aggregation of annotated training images is processed by a neural network algorithm for indicating treatment depth as a function of an ultrasound image 520. The neural network algorithm is then deployed to indicate treatment depth of a depth-monitoring image during a treatment. The depth-monitoring image and/or the indicated depth may be displayed, so that a technician can visualize the treatment in real time. Additionally, the indicated depth may be fed back to the control module in order to adjust treatment parameters in real time.
Reference is now made to
In some embodiments, control module 300 is pre-programmed to follow a particular regimen of ultrasound and cooling parameters. In some embodiments, control module 300 may receive instructions from a user through a user interface 420 (including a display) of the control module 300. Using the user interface 420, the user may set which ultrasonic elements are to be used, their activation times, and the skin surface temperature needed. Alternatively, the user may adjust frequency, power and duty cycle of each of the ultrasonic elements 120U. Through the interface 420 the user may also receive an indication of the skin temperature measured by thermal sensors 210.
Reference is now made to
Experimental studies and results supporting operability of the invention are now described.
The prototype module 120 was tested on fresh bovine liver.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IL2019/051357 | 12/11/2019 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62777940 | Dec 2018 | US |
