Patent Publication Number: US-2022233851-A1

Title: Method and device for skin treatment by muscle stimulation and pressure

Description:
RELATED APPLICATIONS 
     This application is a continuation of and claims priority to U.S. application Ser. No. 16/907,252, filed Jun. 21, 2020, which is a continuation of and claims priority to U.S. application Ser. No. 15/587,487, filed May 5, 2017, now abandoned, which is a continuation of and claims priority to U.S. application Ser. No. 13/510,062, filed May 16, 2012, now abandoned, which is a U.S. National Stage application from and claims priority to PCT Application No. PCT/IL2010/00947, filed Nov. 16, 2010, which claims priority from U.S. provisional application No. 61/261,381 filed on Nov. 16, 2009, all of which disclosures are herein incorporated by reference. 
    
    
     FIELD OF THE INVENTION 
     The present invention relates generally to a device and method for treating skin tissue by using a radio frequency (RF) generator combined with muscle stimulation (MS), including electrical muscle stimulation (EMS). 
     BACKGROUND OF THE INVENTION 
     Skin tissue comprises an outer epidermal layer overlaying a dermal layer. The dermal layer is in contact with a subcutaneous adipose layer referred to as fatty tissue. Massaging the skin is known to improve blood circulation in the subcutaneous adipose tissue and help release fat from the cells of the fatty tissue into the surrounding cellular matrix. The fat is then removed by the body&#39;s lymphatic system. 
     U.S. Pat. No. 5,961,475 to Guitay discloses a massaging device in which negative pressure is applied to the user&#39;s skin while massaging. The combined treatment increases the blood circulation in the subcutaneous adipose tissue and breaks connections between adipose cells in the tissue. 
     U.S. Pat. No. 6,273,884 to Altshuler et al. discloses simultaneous application of optical energy and negative pressure to the user&#39;s skin for treating skin defects. 
     There is however a need for improved methods to enhance the release of fat from adipose tissue to increase lymphatic drainage. 
     SUMMARY OF THE INVENTION 
     An aspect of an embodiment of the invention, relates to an apparatus and method for accelerating lymphatic drainage. The method includes applying RF energy to heat the adipose layer. Additionally the method includes massaging the skin above the area that is heated by RF energy. Further additionally the method includes electrical muscle stimulation (EMS) to contract the muscles below the heated area thus providing pressure on the adipose layer from below. The apparatus is designed to apply the above three methods either separately or any combination of them simultaneously: namely, massaging the skin from above, causing electrical muscle stimulation from below, and heating the fatty tissue with RF radiation. 
     In an exemplary embodiment of the invention, the RF energy is provided by a high frequency AC current, and the EMS energy is provided by a low current DC pulse signal. Optionally, the electrical energies (RF and EMS) are provided by a mono-polar configuration wherein the apparatus applied to the user&#39;s skin is provided with a first electrode of one polarity, and a second electrode of the opposite polarity is attached to the user or held by the user to form a closed circuit. Alternatively, the electrical energy may be provided by a bi-polar configuration wherein the apparatus applied to the userl s skin includes two electrodes to form a closed circuit without attaching electrodes external to the apparatus to the body of the user. In some embodiments of the invention, the apparatus uses a multi-pole configuration wherein the apparatus includes multiple electrodes of both poles of the circuit. 
     In some embodiments of the invention, some electrodes provide RF energy and other electrodes provide EMS energy. Alternatively, the sanle electrodes are designed to synchronize the pulses and deliver any of the two currents by control of the apparatus. 
     In an exemplary embodiment of the invention, the skin massage may be performed by applying positive pressure, for example in the form of vibrations, pushing, pounding and the like. Alternatively or additionally, the skin massage may be perfomled by applying negative pressure, for example using a vacuum or suction and the like. Optionally, the element of the apparatus applying the pressure may be heated or cooled while applying the pressure. 
     In an exemplary embodiment of the invention, when the apparatus is placed m contact with the user 1s skin an electric circuit is formed and electric current flows automatically from the electrode to the user. Optionally, the RF energy may be coordinated with the EMS energy so that both will be activated simultaneously or separately by control of the apparatus. 
     In an exemplary embodiment of the invention, the frequency of the RF energy is selected to heat the user&#39;s skin mainly at the adipose layer positioned under the apparatus. The EMS flow is designed to contract the muscles below the adipose layer causing pressure on the fatty cells from below. 
     In some embodiments of the invention, parameters related to the RF energy are user selectable, for example signal intensity, frequency, duration and the like, to optimize usage of the apparatus for different users or different positions on the body of the user. Optionally, the parameters related to the EMS energy can be modified to fit the needs of the user, for example by selecting intensity, frequency, duration and the like. 
     In some embodiments of the invention, parameters related to massaging the skin are user selectable, for example the vibration rate, duration of vibrations, intensity, temperature of the massaging element and the like. Alternatively, the massaging may be performed by manually pressing the apparatus on the user&#39;s skin and moving it over a designated area. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The present invention will be understood and better appreciated from the following detailed description taken in conjunction with the drawings. Identical structures, elements or parts, which appear in more than one figure, are generally labeled with the same or similar number in all the figures in which they appear, wherein: 
         FIG. 1  is a schematic illustration of a fat reduction device deployed upon a user&#39;s skin, according to an exemplary embodiment of the invention; 
         FIG. 2  is a schematic illustration of liquefied fat exiting from fat cells into the extra cellular matrix responsive to the use of the fat reduction device, according to an exemplary embodiment of the invention; 
         FIG. 3  is a schematic illustration of a fat reduction device applying an electrical current to stimulate a user&#39;s muscles, according to an exemplary embodiment of the invention; 
         FIG. 4  is a schematic illustration of a fat reduction device and the user&#39;s skin following use of the fat reduction device, according to an exemplary embodiment of the invention; 
         FIG. 5  is a schematic block diagram of the elements of a fat reduction device, according to an exemplary embodiment of the invention; and 
         FIG. 6  is a schematic illustration of an RF signal combined with an EMS signal, according to an exemplary embodiment of the invention. 
     
    
    
     DETAILED DESCRIPTION 
       FIG. 1  is a schematic illustration of a fat reduction device  110  deployed upon a user&#39;s skin  120 , according to an exemplary embodiment of the invention. The skin  120  includes an upper epidermal layer  160 , a lower dermal layer  170 , and an adipose layer  140  (fat tissue layer). Muscles  150  are located below the adipose layer  140 . 
     In an exemplary embodiment of the invention, fat reduction device  110  includes one or more heads  115  that serve as massage contacts and optionally also as electrodes for applying electrical energy. Optionally, fat reduction device  110  is adapted to perform at least three actions: 
     1. Massaging the outer layer of skin  120 ; 
     2. Heating the adipose layer  140  using RF energy  130  (e.g., with a frequency between 0.5 MHz to 2 MHz); 
     3. Stimulating the muscles  150  below the adipose layer  140  with an electrical muscle stimulation (EMS) signal (e.g., with pulses of DC current between+/− 500 ma). 
     In an exemplary embodiment of the invention, fat reduction device  110  is deployed upon the user&#39;s skin  120  and applies pressure with heads  115  to massage the skin  120 . Optionally the pressure may be in the form of vibrations, pushing, pounding, or other tactile forms. Alternatively, or additionally, the massaging may be in a negative form, for example by applying a vacuum or suction or similar form.  FIG. 1  demonstrates how the skin  120  takes an uneven form due to the physical pressure exelied upon it. In some embodiments of the invention, fat reduction device  110  includes an element that applies the pressure, for example a motor a piezoelectric chip or other devices known in the art. Alternatively, the pressure may be exerted by manually pressing heads  115  against the user&#39;s skin. 
     In an exemplary embodiment of the invention, the RF energy  130  is delivered through the skin to the adipose layer  140 . The RF energy  130  accelerates natural fat cell metabolism causing the release of liquefied fat from the cells into the extra cellular matrix. Additionally, the RF energy  130  heats collagen fibers and stimulates fibroblast metabolism resulting in tightening of the skin  120  and an increase in new collagen production. 
     Optionally, the physical pressure loosens the ties between the fat cells and together with the heating from the RF energy  130  accelerates release of liquefied fat from the fat cells. The heating and massaging also increase blood flow thus providing more nourishment to the area and removing dead cells and other impurities at all increased rate. 
       FIG. 2  is a schematic illustration of liquefied fat  220  exiting from fat cells  210  into the extra cellular matrix responsive to the use of the fat reduction device  110 , according to an exemplary embodiment of the invention. In an exemplary embodiment of the invention, the RF energy is set to heat the fat cells  210  to a level wherein the temperature on the surface of the skin does not exceed 40° C.-45° C. to prevent skin damage. Optionally, higher temperature ranges may be possible for short durations. 
       FIG. 3  is a schematic illustration of fat reduction device  110  applying an electrical current  310  to stimulate the user&#39;s muscles  150 , according to an exemplary embodiment of the invention. In an exemplary embodiment of the invention, electrical current  310  from the electrical muscle stimulation (EMS) pulse causes the muscles  150  to contract below the adipose layer  140 , which causes a dual force to be applied to the fat cells  210 . From above the adipose layer  140  is pressured physically by fat reduction device  110  and from below the EMS signals cause the muscles  150  to exert pressure on adipose layer  140 . In some embodiments of the invention, the RF energy  130  and/or the EMS pulse may be activated by an activation switch on fat reduction device  110 . Alternatively, they may be activated upon contact with the user&#39;s skin, for example by closing a circuit through the user&#39;s skin or by applying pressure on the head of fat reduction device  110 . 
       FIG. 4  is a schematic illustration of fat reduction device  110  and the user&#39;s skin  120  following use of fat reduction device  110 , according to an exemplary embodiment of the invention. Optionally, after applying fat reduction device  110  the distance between the muscles  150  and the epidermal layer  160  is reduced due to the exit of liquefied fat from the fat cells  210  of the adipose layer  140 . Additionally, the epidermal layer  160  becomes smoother due to the tightening resulting from the collagen production as described above. 
       FIG. 5  is a schematic block diagram of the elements of fat reduction device  110 , according to an exemplary embodiment of the invention. In an exemplary embodiment of the invention, fat reduction device  110  includes an RF generator  510  to provide an AC current in the form of a radio frequency (RF) electrical pulse for heating the user&#39;s skin  120 . Optionally the AC signal is a low current signal, for example of about 1-1 Oma, 24VAC with a frequency between 0.5 MHz-2 MHz to prevent damage to the user&#39;s skin  120 . In an exemplary embodiment of the invention, fat reduction device  110  also includes an electric pulse (EP) generator  520  that provides low current DC pulse signals, for example between +500 ma to −500 ma to cause the muscles  150  to expand and contract. In an exemplary embodiment of the invention, fat reduction device  110  includes a control board  530  that determines the actions of the device. Optionally, control board  530  may be a general purpose computer or a dedicated circuit. Control board  530  controls the duration, intensity, frequency and any other parameters of the electric pulses of the electrical current  310  for stimulating the muscles  150 , and the RF energy  130  for heating the adipose layer  140 . Additionally, the control board  530  determines the timing for applying the EP signal and the RF signal. In some embodiments of the invention, control board  530  includes a CPU, a memory, and input/output devices, for example a keypad and a screen. 
     In some embodiments of the invention, the control board accepts measurements from various sensors and controls fat reduction device  110  responsive to the measurements, for example temperature readings from a temperature sensor  550 , which may include a thermistor or thermocouple monitoring the skin temperature. Optionally, the sensors may be placed in head  115 , for example adjacent to the electrodes. 
     In a . . . 11 exemplary embodiment of the invention, fat reduction device  110  includes an applicator  540  for applying the actions described above. In an exemplary embodiment of the invention, fat reduction device  110  is fed from a power source  590 . Optionally, the power source  590  may be an internal power source, for example a battery. Alternatively, power source  590  may be an external power source, for example by connecting a power cable to a standard household power outlet. 
     In an exemplary embodiment of the invention, applicator  540  includes one or more heads  115  that serve as massage contacts  560 , and electrodes  570 . In some embodiments of the invention, the applicator may include an activation switch  580  to turn on and off fat reduction device  110 , Optionally, activation switch  580  may be independently controlled by the user or may be automatically controlled, for example by placing fat reduction device  110  in contact with the userls body so that an electric circuit is formed or by pressing the fat reduction device  110  against the user&#39;s body causing the activation switch  580  to be depressed. 
     In some embodiments of the invention, fat reduction device  110  may use a mono-polar configuration wherein one pole of the circuit is represented by one or more electrodes on heads  115  and placed in contact with the user&#39;s skin. Optionally, the opposite pole is placed as a patch on the user&#39;s body or on a handle for grasping fat reduction device  110 , to form a closed circuit. Alternatively, fat reduction device  110  may use a bi-polar configuration wherein both poles are represented by electrodes on the head  115  of the device, and no external electrodes are required. In some embodiments of the invention, a multi-polar configuration is used, with multiple electrodes wherein some of the electrodes on head  115  represent a first pole of the circuit and some represent the opposite pole. Optionally, the polarity of the electrodes may be controlled by control board  530 , and their polarity may alternate during use of fat reduction device  110 . 
     In some embodiments of the invention, some of the electrodes deliver RF energy  130  and some deliver electrical current  310 . Alternatively, the same electrodes may deliver RF energy  130  and electrical current  310  intermittently. In some embodiments of the invention, electrical current  310  from the electrical muscle stimulation (EMS) signal is applied independent of the RF energy signal  130 . 
     In an exemplary embodiment of the invention, control  530  controls the actions of the massage contacts  560 . Optionally, the massage contacts  560  may include a motor, a piezoelectric element, a suction, a vacuum or other devices to massage the user&#39;s skin either positively or negatively. In an exemplary embodiment of the invention, the action of massage contacts  560  are synchronized with the electrical muscle stimulation (EMS) so that the adipose layer will be pressurized on both sides simultaneously. Alternatively, each function may act independently. In some embodiments of the invention, the massage is applied manually by pressing massage contacts  560  against the user&#39;s skin  120 , and optionally moving them back and forth across the user&#39;s skin  120 . Optionally, massage contacts  560  may be made from a soft material or hard material selected for providing a comfortable feeling to the user while massaging the user&#39;s skin  120 . In some embodiments of the invention, the massage contacts  560  may include a heater to warm the contacts to enhance comfort and/or effectiveness of the massage. 
       FIG. 6  is a schematic illustration of an RF energy signal synchronized with an EMS signal, according to an exemplary embodiment of the invention. In an exemplary embodiment of the invention, an electric pulse  610  of for example 100 micro-seconds is provide during an interval of 1 ms after which a RF energy signal  620  is applied, for exanlple for a duration of 9 ms. This sequence is applied repetitively while the fat reduction device is activated. Optionally, other duration may be used, for example the duration of electric pulse  610  may be longer than the duration of RF radiation signal  620  or vice versa. 
     It should be appreciated that the above-described methods and apparatus may be varied in many ways, including omitting or adding steps, changing the order of steps and the type of devices used. It should be appreciated that different features may be combined in different ways. In particular, not all the features shown above in a particular embodiment are necessary in every embodiment of the invention. Further combinations of the above features are also considered to be within the scope of some embodiments of the invention. 
     It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather the scope of the present invention is defined only by the claims, which follow.