Patent Publication Number: US-2016228322-A1

Title: Method and apparatus for non-invasive aesthetic treatment of skin and sub-dermis

Description:
TECHNICAL FIELD 
     The method and apparatus relate to the field of aesthetic body shaping devices and more specifically to methods and apparatuses for aesthetic massage treatment of human skin and sub-dermis. 
     BACKGROUND 
     Cellulite affects around 85-90% of post-pubertal females and some men of all races and is characterized by a dimpled appearance of the skin. It occurs mainly around the arms, hips, thighs, and buttocks. 
     Collagen fibrous walls in the sub-dermal fat layer, named septae, connect the sub-dermal fat tissue to the skin. Cellulite occurs when sub-dermal fat cells are pushed upwards, and the septae pushed downwards pulling the attached skin with them. As a result, the septae urge the fat cells deposited therebetween into small bulges protruding from the surface of the skin and resulting in a characteristic dimpled, pitted appearance of the skin surface. 
     Numerous therapies are used in the treatment of cellulite which include physical and mechanical methods as well as the use of pharmacological agents. The physical and mechanical methods include iontophoresis, light, ultrasound, thermotherapy, pressotherapy (pneumatic massaging in the direction of the circulation), lymphatic drainage (massage technique to stimulate lymphatic flow), electrolipophoresis (application of a low frequency electric current) and high frequency electrical current such as RF. 
     Aesthetic treatments of cellulite combining the application of sub-atmospheric pressure (a vacuum) to a segment of skin, urging it into a chamber and skin massage, with or without the application of heat energy, are documented in the art. 
     Almost all massage elements described in the art are based on mechanical displacement of a moving part, such as a roller or a pivoting divider. In most cases this mechanical action is driven by an actuator such as a motor. In few cases vacuum is used for manipulation of a mechanical element. 
     The use of moving mechanical elements and actuators in such applicators increases their complexity, required maintenance and cost. Moving mechanical elements may also interfere with the various types of heating energy delivery surfaces typically employed by such applicators. 
     Attempts have been made in the art to simplify applicators by replacing the mechanical elements with a deformable membrane, the inside surface thereof sealing a vacuum chamber and the outside surface adhering to the skin. Creation of sub-atmospheric pressure inside the chamber creates a suction effect on the membrane and skin, drawing both into the chamber. 
     Furthermore, MR imaging 3D reconstruction of the collagen fibrous septae network in the skin tissue demonstrates a high percentage of septae oriented in a direction perpendicular to the skin surface in women with cellulite. The massage elements described in the art cause the skin tissue to move in and out of a single vacuum chamber, resulting in displacement of the skin tissue in a direction vertical to the skin surface and in parallel to the fibrous septae orientation. 
     Additionally, methods in the art couple heating energy treatment to the skin massage treatment. The applied energy source (For example, ultrasound) employed by these methods is typically positioned over skin areas that are not adhered to a vacuum chamber or a deformable membrane and therefore are not being concurrently massaged. Application of energy to non-massaged skin areas negates the synergistic effect produced by the concurrent combination of skin massage and energy application. 
     The combination of heat and concurrent back and forth massaging movement of skin break down the fibrous septae network thus eliminating the pitted appearance of the skin surface. The combination of heat and vacuum also enhances circulation in the treated area and increases metabolic action, which reduces the amount of sub-dermal fat further contributing to the elimination of the pitted appearance of the skin surface. Therefore, there is a need for improved cellulite treatments that would include massaging movement of skin, with or without the application of heating energy, would bring improved treatment results and better elimination of the undesired effects of cellulite. 
     SUMMARY 
     The present method and apparatus effect vacuum and massage to human skin tissue for reduction of effects of cellulite. The method and apparatus are based on coupling an applicator accommodating one or more vacuum chambers sharing one or more common walls therebetween to the surface of the skin and alternately reducing the air pressure in the vacuum chambers to affect vacuum suction to the skin, alternately drawing adjacent segments of skin into the vacuum chambers. 
     The alternating suction effect generates enhanced massaging back and forth movement of the skin tissue against the common wall between adjacent vacuum chambers, parallel to the skin surface and perpendicular to the collagen fibrous septae orientation. This action is achieved using vacuum chambers alone without the use of mechanical actuators and/or any moving parts. 
     The method and apparatus also couple heating energy to the application of vacuum and massage. Such heating energy may be in different forms selected from a group of light, RF, ultrasound, electrolipophoresis, iontophoresisand and microwaves and delivered by heating energy delivery surfaces. The heating energy delivery surfaces may be located in one or more locations including inside the vacuum chambers, between the vacuum chambers or any combination thereof. 
     According to an exemplary embodiment of the method and apparatus, the vacuum chamber walls, or segments thereof, are made of conductive material and are operative to deliver RF heating energy. Alternatively, only the common wall between adjacent vacuum chambers may be made of an electrically conductive material and function, as a whole, as an RF electrode. 
     According to another exemplary embodiment of the method and apparatus one or more RF electrodes are located on the inner face of one or more walls of adjacent vacuum chambers. Additional one or more RF electrodes are located on either or both faces of the common wall therebetween. Alternatively and additionally, the RF electrodes may extend beyond the inner face of the vacuum chamber walls to apply heating energy to adjacent skin tissue about to be drawn into the vacuum chambers. 
     RF energy delivery may be controlled by a machine controller in only one vacuum chamber or more than one vacuum chambers, concurrently, in an alternating fashion or in any other sequence according to a predetermined treatment protocol. 
     According to yet another exemplary embodiment of the method and apparatus the machine control is operative to control the alternating sequence of vacuum application in adjacent vacuum chambers as well as the type of air pressure so that to effect an asymmetric massaging movement of the skin tissue in parallel to the surface of said skin so as to displace the applicator along the surface of the skin. 
     Exemplary embodiments of the method and apparatus may also be employed in other aesthetic skin tissue treatments such as sub-dermal fat cells breakdown lessening the amount of sub-dermal fat, tightening loose skin, tightening and firming body surface, reducing wrinkles in the skin and collagen remodeling. 
     GLOSSARY 
     The terms “Skin tissue” and “Skin” are used interchangeably in the present disclosure and mean the superficial layer of skin including the epidermis and dermis and all dermal structures such as sensory nerve endings, blood vessels, sweat glands, etc. 
     The term “Sub-Dermis” as used in the present disclosure means the skin layer below the dermis including tissues such as fat and collagen fibrous septae. 
     The terms “Vacuum”, “Suction” and “Sub-atmospheric air pressure” are used interchangeably in the present disclosure and mean any air pressure less or lower than ambient air pressure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present method and apparatus will be understood and appreciated from the following detailed description, taken in conjunction with the drawings in which: 
         FIG. 1  is a simplified cross-sectional view of an applicator for treatment of human skin and sub-dermis in accordance with an exemplary embodiment of the present method and apparatus. 
         FIGS. 2A, 2B, 2C &amp; 2D , collectively referred to as  FIG. 2 , are simplified illustrations of various alternative configurations of the energy delivery surfaces of the apparatus of  FIG. 1 ; 
         FIGS. 3A, 3B, 3C &amp; 3D , collectively referred to as  FIG. 3 , are simplified illustration of the operation of the applicator of  FIG. 1  in massaging the skin tissue in accordance with another exemplary embodiment of the method and apparatus. 
         FIGS. 4A, 4B, 4C, 4D, 4E and 4F , collectively referred to as  FIG. 4 , are simplified illustration of the operation of the applicator of  FIG. 1  effecting the displacement thereof in accordance with yet another exemplary embodiment of the method and apparatus. 
         FIG. 5  is a simplified illustration of the apparatus of  FIG. 1  arranged in a three-chamber arrangement. 
         FIG. 6  is a simplified illustration of the apparatus of  FIG. 1  further including a roller in accordance with still another exemplary embodiment of the method and apparatus. 
         FIG. 7  is a simplified illustration of the apparatus of  FIG. 1  further including a flexible divider between adjacent vacuum chambers in accordance with further exemplary embodiment of the method and apparatus. 
     
    
    
     DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS 
     Reference is now made to  FIG. 1 , which illustrates a cross-sectional view of an applicator  100  having a housing  102  accommodating one or more vacuum chambers.  FIG. 1 , for example, illustrates two vacuum chambers  104 . Chambers  104  are defined by the inner surfaces of walls  106  and  108 , closed portion  110  and the surface of skin tissue  116 . Sealing edges  114  of walls  106  may be flared to increase contact area with the surface of skin tissue  116  and provide a better seal therewith. Additionally, sealing edge  114  of wall  108  may be coated with a high friction coating to enhance massaging of skin tissue  116  being urged there against. For example, the vacuum chamber may be of the type disclosed in assignee&#39;s U.S. patent application assigned Ser. No. 12/503,834 the disclosures of which is hereby incorporated by reference. 
     One or more sources of one or more air pressure types selected from a group consisting of sub-atmospheric air pressure, positive air pressure and ambient air pressure communicate with chambers  104 . For example, in the exemplary embodiment shown in  FIG. 1 , sub-atmospheric air pressure is applied to chambers  104  through a conduit  122  and a bore  120  in closed portion  110  thus creating a vacuum within chambers  104 . Chambers  104  are also vented to the surrounding ambient air through conduit  126 . Alternatively positive air pressure may be delivered through conduit  126  or through another conduit (not shown). 
     The desired source of air pressure in chambers  104  is selected by employing a valve  124 , which may be any standard single-way or multiple way valve as known in the art. 
     Vacuum values within vacuum chambers  104  may be within the range of 0.05 Bar to 1 Bar below ambient pressure. Typically, the vacuum values are within the range of 0.1 Bar to 0.5 Bar below ambient pressure. 
     A machine controller (not shown) connected to each selector valve  124  by electrical conductors  128  selects the desired type of air pressure and sequence of application thereof, for each vacuum chamber  104  individually, from a multiplicity of predetermined treatment program protocols. For example, alternating the application of sub-atmospheric pressure in each of two adjacent vacuum chambers  104  creates alternating suction forces on adjacent areas of treated skin tissue  116 , urging skin tissue  116  to move in and out of the corresponding vacuum chambers  104 . Suction of skin tissue  116  into a vacuum chamber  104  creates a skin protrusion (as illustrated in  FIGS. 3 and 4 ) drawing adjacent skin tissue into the chamber. Concurrent relief of suction in an adjacent chamber  104  releases the tension on the protrusion within the chamber allowing skin tissue  116  to relax, exit the chamber and be drawn into the adjacent chamber  104  in which suction is concurrently being applied. This creates additional and concurrent back and forth movement of skin tissue  116 , between adjacent chambers  104 , parallel to the surface of skin tissue  116 , against the sealing edge  114  of wall  108 . This parallel skin and tissue movement creates a massaging effect, perpendicular to the collagen fibrous septae in the sub-dermis (not shown) resulting in breaking down of the septae. Actuation of the skin tissue parallel to the surface thereof and perpendicular to the collagen fibrous septae orientation has been shown to be more effective in breaking down the fibrous septae and reducing the ill-effects of cellulite and will be described below in detail. 
     According to an exemplary embodiment of the method and apparatus heating energy may be coupled to skin tissue  116  concurrently with the application of vacuum and massage. Such heating energy may be in different heating energy forms selected from a group consisting of light, RF, ultrasound, electrolipophoresis, iontophoresis and microwaves. Different forms of energy may be concurrently applied in each chamber. 
     According to an exemplary embodiment of the method and apparatus, RF energy is employed so that energy is delivered into skin tissue to heat the skin and sub-dermal tissues inside, and adjacent to, the vacuum chambers that are concurrently being massaged. This produces a synergistic effect and enhances the breakdown of the dermal collagen fibrous septae. 
     The sequence and duration of RF energy emission by the RF electrodes in vacuum chambers  104  is synchronized with the sequence and duration of application of the selected type of air pressure in vacuum chambers  104  by the machine controller (not shown) connected to switch  138  (connection not shown). 
     Commonly RF frequency is in the range from 50 KHz to 200 MHz. Typically, RF frequency is from 100 KHz to 10 MHz or from 100 KHZ to 100 MHz or, alternatively, from 300 KHz to 3 MHz. 
     Commonly, RF power is in the range from 0.5 W to 300 W. Typically, the range of the RF power is from 1 W to 200 W or from 10 W to 100 W. 
     Commonly, the range of ultrasound energy frequency is from 100 kHz to 10 MHz. Typically, the range of ultrasound energy frequency is from 500 kHz to 5 MHz. Typically, the range of power density is 0.1 W/cm2 up to 5 W/cm2. 
     Reference is now made to  FIGS. 2A, 2B, 2C, and 2D , which are simplified illustrations of various alternative configurations of the energy delivery surfaces of the apparatus of  FIG. 1 . 
     In the embodiment of  FIG. 2A , heating energy delivery surfaces  202  are located on the inner face of walls  206  of adjacent vacuum chambers and energy delivery surfaces  214  are located on both faces of the common wall  208  therebetween. 
     In the embodiment of  FIG. 2B , heating energy delivery surfaces  202  extend beyond the inner face of the vacuum chamber walls  206 , of which sealing edges  214  are flared outwardly to provide extended heating energy delivery surfaces and apply heating energy not only to tissues within vacuum chambers  204 , but to adjacent skin tissue  216  as well about to be drawn into the vacuum chambers. 
     In the embodiment of  FIG. 2C , heating energy delivery surfaces  202  are located on the inner face of walls  206 , which are made of an electrically insulating material. Wall  208  is made of a conductive material, as indicated in  FIG. 2C  by a diagonal-lines-fill, and serves, as a whole, as an RF electrode. 
     In the embodiment of  FIG. 2D , Walls  206  and  208  are electrically conductive, in which case walls  206  and  208 , as a whole, serve as RF electrodes. The walls bordering walls  206  and  208  (not shown) are made of an electrically insulating material. Alternatively, segments of walls  206  and  208  may be electrically conductive while others may be electrically insulated. 
     In any one of the above configurations, wall  208 , or energy delivery surface  202  thereon, is electrically connected to pole  230  of an RF energy source through conductor  232 . A pole  234  of the RF energy source is electrically connected to one or more walls  206 , or energy delivery surfaces  202  thereon, through conductors  236 . RF energy delivery from the RF energy source to walls  206  and  208 , or energy delivery surface  202  thereon, is controlled by switch  238 . 
     It will be appreciated that apparatus  100  may employ any one or combination of the above configurations. 
     Reference is now made to  FIGS. 3A, 3B, 3C &amp; 3D , which illustrate stages of the operation of applicator  100  of  FIG. 1  in massaging the skin tissue  316  and sub-dermis  320 , including collagen fibrous septae, which are generally in parallel to the surface of skin  316 , in accordance with an exemplary embodiment of the method and apparatus. 
     In  FIG. 3A , sub-atmospheric pressure is applied in vacuum chamber  304 , as indicated by arrow  340 , drawing skin tissue  316  and sub-dermis  320  into chamber  304  creating skin protrusion  318 . The suction of skin tissue  316  and sub-dermis  320  into vacuum chamber  304  draws adjacent skin tissue to converge, parallel to the surface of skin tissue  316 , towards and into vacuum chamber  304  as depicted by arrows designated by reference numeral  350 . This movement urges skin tissue  316  and sub-dermis  320  against sealing edges  314  of walls  306  and  308  massaging skin tissue  316  and breaking down collagen fiber septae in sub-dermis  320 , which are perpendicular in orientation to the direction of movement of skin tissue  316 . 
     In  FIG. 3B , protrusion  318  fills vacuum chamber  304 , suction is maintained by sub-atmospheric pressure in chamber  304 , as indicated by arrow  342 , holding in place protrusion  318 . 
     In  FIG. 3C , chamber  304  is vented, increasing the pressure inside the chamber to ambient atmospheric pressure and releasing the suction holding in place protrusion  318  inside chamber  304 . Concurrently, sub-atmospheric pressure is applied in vacuum chamber  324 , as indicated by arrow  370 , sucking skin tissue  316  into chamber  324  creating protrusion  328 . Concurrent relief of suction in adjacent chamber  304  releases the tension on the protrusion within the chamber allowing skin tissue  316  to relax, exit the chamber, travel in parallel to the surface of skin  316 , as depicted by the arrow here designated by reference numeral  352 , and be drawn into the adjacent chamber  324  in which suction is concurrently being applied. This creates additional and concurrent back and forth movement of skin tissue  316 , between adjacent chambers  304  and  324 , parallel to the surface of skin tissue  316 , against the sealing edge  314  of wall  308 . This movement, perpendicular to the orientation of the collagen fibrous septae, strongly urges skin tissue  316  and sub-dermis  320  against sealing edge  314  of wall  308 , further massaging the tissue, applying enhanced shearing forces to the collagen fibrous septae in the sub-dermis  320 , breaking down the septae as indicated by reference numeral  322 . Alternatively, positive air pressure may be pumped into chamber  304 , as indicated by arrow  360 , forcing protrusion  318  out of vacuum chamber  304 , strongly urging skin tissue  316  against sealing edge  314  of wall  308  and further enhancing the shearing forces on the collagen fibrous septae in the sub-dermis  320 . 
     In  FIG. 3D , protrusion  328  fills vacuum chamber  324 , sub-atmospheric pressure is maintained in chambers  324 , as indicated by arrow  380 , holding in place protrusion  328  and all movement of skin tissue is stopped. 
     It is appreciated that this cycle may be repeated or reversed, with or without concurrent energy treatment application, in accordance with a predetermined treatment program protocol to effect enhanced back and forth symmetrical massaging movement of the skin tissue  316  against sealing edge  314  of common wall  308  in parallel to the surface skin tissue  316 , further breaking down the collagen fibrous septae in the sub-dermis. 
     Reference is now made to  FIGS. 4A, 4B, 4C, 4D &amp; 4F , which illustrate the sequence of the application of air pressure to adjacent vacuum chambers effecting asymmetrical skin movement and displacement of the applicator  100  of  FIG. 1  along the surface of the skin  416  in accordance with an exemplary embodiment of the method and apparatus. 
     In  FIG. 4A , sub-atmospheric pressure is applied in vacuum chamber  404 , as indicated by arrow  440 , sucking skin tissue  416  into chamber  404  and creating protrusion  418 . Suction of skin tissue  416  into vacuum chamber  404  draws adjacent skin tissue to symmetrically converge, parallel to the surface of skin tissue  416 , towards vacuum chamber  404  as depicted by arrows designated by reference numeral  450 . At this stage, there is no directional displacement of applicator  100 . 
     In  FIG. 4B , skin tissue protrusion  418  fills vacuum chamber  404  and suction in chamber  404  is maintained. 
     In  FIG. 4C , sub-atmospheric pressure continues to be maintained in chamber  404 , as indicated by arrow  440 , holding in place protrusion  418 . Concurrently, sub-atmospheric pressure is applied in vacuum chamber  424 , as indicated by arrow  470 , sucking skin tissue  416  into chamber  424  and creating protrusion  428 . The movement of skin tissue  416  into vacuum chamber  424  asymmetrically draws adjacent skin tissue to travel parallel to the surface of skin tissue  416 , towards vacuum chamber  424  as depicted by the arrow here designated by reference numeral  452 . This asymmetrical movement of skin tissue  416  also pulls skin protrusion  418 , strongly adhered to chamber  404 , in a direction opposite to that indicated by arrow  452 , effecting directional displacement of applicator  100  in a direction indicated by arrow designated by reference numeral  490 . 
     In  FIG. 4D , sub-atmospheric pressure is maintained in both chambers  404  and  424 , holding in place protrusions  418  and  428  respectively. At this stage, there is no displacement of applicator  100 . 
     In  FIG. 4E , sub-atmospheric pressure is maintained in chamber  424 , holding skin protrusion  428  in place. Concurrently, chamber  404  is vented, increasing the pressure inside the chamber to surrounding ambient air pressure and releasing the vacuum holding protrusion  418  inside chamber  404  in place. Alternatively, positive air pressure is pumped into chamber  404 , as indicated by arrow  460 , urging skin protrusion  418  out of vacuum chamber  404 . This releases the pulling tension on the skin tissue between chambers  404  and  424  and allowing the relaxed skin tissue to stretch asymmetrically in a direction indicated by arrow  454  and further effect directional displacement of applicator  100  in a direction opposite to that indicated by arrow  454 , here indicated by arrow  492 . 
     In  FIG. 4F , chamber  424  is vented, increasing the pressure inside the chamber to surrounding ambient air pressure and releasing the suction holding protrusion  428  inside chamber  424  in place. Alternatively, positive air pressure is pumped into chamber  424 , as indicated by arrow  480 , urging skin tissue protrusion  428  out of vacuum chamber  404  and effecting symmetrical movement of skin tissue  416  in a direction indicated by arrows  456 . At this stage there is no displacement of applicator  100 . 
     It is appreciated that this cycle may be repeated or reversed, with or without concurrent energy treatment application, in accordance with a predetermined treatment program protocol to effect back and forth massaging skin tissue  416  in parallel to the surface thereof, further breaking down the collagen fibrous septae in the sub-dermis  420 , which are perpendicular in orientation to the direction of movement of skin tissue  416 . Additionally and alternatively, this cycle may be repeated or reversed, with or without concurrent energy treatment application, in accordance with a predetermined treatment program protocol to alternate the application of suction inside adjacent chambers asymmetrically, effecting movement of applicator  100  along the surface of skin tissue  416 . 
     Reference is now made to  FIG. 5 , which is a simplified illustration of applicator  100  of  FIG. 1  arranged in a three-vacuum chamber arrangement. It will be appreciated that applicator  100  may arranged in plurality of multiple-chamber arrangements including two or more chambers arranged in a row, a grid-like arrangement or arranged in any other suitable geometrical pattern. 
     Reference is now made to  FIG. 6 , which is a simplified illustration of applicator  100  of  FIG. 1  in accordance with an exemplary embodiment further including a roller  602  at the sealing edge  614  of common wall  608  between two adjacent vacuum chambers  604  and  624  in accordance with an exemplary embodiment of the method and apparatus. Roller  602  reduces friction at the sealing edge  614  of wall  608  and facilitates back and forth displacement of applicator  100  over the surface of skin tissue  616  as indicated by arrow  650 . It will be appreciated that roller  602  may be placed at the sealing edge of any wall, such as  606  and be replaced with any element that facilitates the massaging of skin tissue  616  and displacement of applicator  100  such as a ball, a cylinder, sliders, etc. Additionally and alternatively, roller  602  may be shaped to enhance massaging of skin tissue  616  being urged thereagainst. 
     Reference is now made to  FIG. 7 , which is a simplified illustration of applicator  100  of  FIG. 1  in accordance with an exemplary embodiment further including a flexible divider  702  flexibly attached to, or partially embedded in, common wall  708  between adjacent vacuum chambers  704  and  724 . Flexible divider  702  may be made of any suitable flexible material, which would allow pivotal back and forth movement of divider  702  as indicated by arrow  750 . Alternatively, flexible divider  702  may made of either a flexible or rigid suitable material and pivotally attached to the sealing edge of wall  708 . 
     It will be appreciated that exemplary embodiments of the method and apparatus may be also employed in other aesthetic skin tissue treatments such as sub-dermal fat cells breakdown lessening the amount of sub-dermal fat, tightening loose skin, tightening and firming body surface, reducing wrinkles in the skin and collagen remodeling. 
     It will also be appreciated by persons skilled in the art that the present method and apparatus is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the method and apparatus includes both combinations and sub-combinations of various features described hereinabove as well as modifications and variations thereof which would occur to a person skilled in the art upon reading the foregoing description and which are not in the prior art.