Abstract:
System and method for treating a skin target. A temperature effector creates a temperature difference between the target and the skin tissue surrounding the target such that the target is at a higher temperature than the surrounding the. One or more RP electrodes are attached to the skin and RE energy is applied.

Description:
FIELD OF THE INVENTION  
         [0001]    This invention relates to methods and systems for treating skin.  
         BACKGROUND OF THE INVENTION  
         [0002]    The term “target” is used herein to denote a skin defect such as a vascular lesion, pigmented lesion, acne, unwanted hair or wrinkle. Selective thermal treatment of skin is commonly used in aesthetic medicine to remove skin targets. In order to be destroyed, the target must be raised to a temperature of about 70° C. without raising the temperature of the surrounding epidermis or dermis to damaging levels. The most popular method of thermal skin treatment is selective photo-thermolysis in which light energy produced by a laser or flash lamp is selectively absorbed by a pigmented portion of the target. However, with this method it is often not possible to heat the entire target to a temperature necessary for destroying it without heating the surrounding skin to damaging levels. The main problem is that the optical contrast between the target and the surrounding skin tissue is not high enough to obtain a significant difference in temperature between the target and the surrounding skin tissue.  
           [0003]    U.S. Pat. No. 5,755,753 disclose use of the radio-frequency (RF) range of electro-magnetic energy for skin tightening, where RF energy is applied to a pre-cooled skin surface. U.S. Pat. No. 5,846,252 discloses treating hairs to reduce their electrical resistance and then applying RF current.  
         SUMMARY OF THE INVENTION  
         [0004]    The present invention is based upon the finding that selective heating of a skin target by RF energy is enhanced if prior to the application of the RF energy the skin is treated to make the temperature of the target (T t ) higher than the temperature of the surrounding skin tissue (T s ). The initial temperature gradient (T t −T s &gt;0) between tie target and surrounding tissue may be achieved either by preheating the target or pre-cooling the surrounding tissue.  
           [0005]    The invention thus provides a system for treating a skin target comprising:  
           [0006]    (a) one or more RF electrodes configured to be attached to the skin, so as to apply an RF current to the skin;  
           [0007]    (b) a temperature effector configured to create a temperature gradient between the target and skin surrounding the target such that the target is at a higher temperature than the surrounding skin.  
           [0008]    The invention still further provides a method for treating a skin target comprising:  
           [0009]    a) creating a temperature gradient between the target and skin surrounding the target such that he target is at a higher temperature than the surrounding skin; and  
           [0010]    b) applying RF energy to the skin.  
           [0011]    The system and method of the invention may be used for such skin targets as a vascular lesion, pigmented lesion, hair follicle, wrinkle and acne.  
           [0012]    While not wishing to be bound by a particular theory, it is believed that selective thermolysis of a target by RF energy is enhanced when T t −T s &gt;0 due to an increase in the electrical conductivity in the RF range of tissues when thee tissue temperature is increased [Frances A. Duck, Physical Properties of Tissue, a Comprehensive Reference Book, Academic Press, 1990, p.173]. Accordingly, the dependence of the conductivity a of a tissue on temperature T is given by:  
           σ=σ 0 (1+α( T−T   0 ))  (1)  
           [0013]    where σ 0  is the conductivity at the reference temperature T 0  and α is a constant known as the temperature coefficient.  
           [0014]    Heat generation by RF current can be estimated by Joule&#39;s Law:  
             H=σE   2   (2)  
           [0015]    and the change in temperature in the tissue is obtained using the heat conductivity equation:  
               c                 ρ          ∂   T       ∂   t         =   H           (   3   )                               
 
           [0016]    where c is the heat capacity of the tissue, ρ is the mass density and E is the intensity of the electric field.  
           [0017]    Inserting Equations 1 and 2 into (3),  
               c                 ρ          ∂   T       ∂   t         =       σ   o     (     1   +       α        (     T   -     T   o       )            E   2                   (   4   )                 Setting                 A     =         ασ   o          E   2         c                 ρ               (   5   )                               
 
           [0018]    and integrating Equation 4, the result is  
               T   ′     =       T   o     +            At     -   1     α     +       (       T   i     -     T   o       )             At                 (   6   )                               
 
           [0019]    where T i  is the initial temperature of the tissue before the application of RF energy, t is the duration of the application of RF energy, and T′ is the formal temperate of tie tissue at the end of the application of RF energy.  
           [0020]    If the initial temperatures of the target and sounding skin tissue are T t  and T s  respectively (T t T s &gt;0), then Equation 6 becomes for the target:  
               T   t   ′     =       T   o     +            At   -   1       α     +       (       T   ij     -     T   to       )        A                      it                 (   7   )                               
 
           [0021]    and for the surrounding skin,  
               T   s   ′     =       T   0   ′     +            At     -   1     α     +       (       T   st     -     T   o       )             At                 (   8   )                               
 
           [0022]    subtracting Equation (8) from Equation (7) yields  
             T′   t   −T′   s =( T   ti   −T   si ) e   At   (9)  
           [0023]    where T ti −T si  is the initial temperate gradient between the target and the surrounding skin, and T′ t −T′ s  is the final temperature gradient. Equation (9) shows that as the RF current is applied, the temperature gradient increases exponentially. Therefore, by creating an initial relatively small temperature gradient T ti −T si &gt;0, and applying RF energy, a larger temperature gradient is obtained. This allows heating of the target to a sufficiently high temperature to destroy the target without heating the surrounding skin tissues to damaging levels.  
           [0024]    Assuming a typical RF fluence (F) in the skin of 20 J/cm 2 , α=0.03 (C°) −1  and a heat capacitance cρ=3.6 J/cm 3 °K the factor e At  in Equation (9) is  
            At     =       e            ασ   o          E   2         c                 ρ         =       e          α                 Ht       c                 ρ         =          0.83     =   2.3                               
 
           [0025]    Thus, the temperature gradient increases by a factor of about 2.3 during the application of the RF energy. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0026]    In order to understand the invention and to see how it may be carried out in practice, a preferred embodiment will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which:  
         [0027]    [0027]FIG. 1 shows a system for heating a skin target and applying RF to an individual in accordance with one embodiment of the invention;  
         [0028]    [0028]FIG. 2 shows a method for treating skin using the system of FIG. 1;  
         [0029]    [0029]FIG. 3 shows an applicator with two electrodes, and a light source used in tie system of FIG. 1.  
         [0030]    [0030]FIG. 4 shows a system for cooling skin surrounding a target and applying RF energy to an individual in accordance with another embodiment of the invention;  
         [0031]    [0031]FIG. 5 shows an applicator with two electrodes, and a cooling system used in the system of FIG. 3; and  
         [0032]    [0032]FIG. 6 shows a method for treating skin using the system of FIGS. 4 and 5. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0033]    Referring to FIGS. 1 and 2, a system for creating a temper gradient between a skin target and the surrounding skin, in accordance with the invention is shown. An applicator  703 , to be described in detail below, contains a pair of RF electrodes  401  and  402  and a light source  403 . The applicator  703  is adapted to be applied to the skin of an individual  705  in the region of a target. The applicator  703  is connected to a control unit  701  via a cable  702 . The control unit  701  includes a power source  708 . The power source  708  is connected to an RF generator  715  that is connected to the RF electrodes in the applicator  703  via wires in the cable  702 . The power source  708  is also connected to a light source  403  in the applicator  703  via wires in the cable  702 . The control unit  701  has an input device such as a keypad  710  that allows an operator to input selected values of parameters of the treatment, such as the frequency, pulse duration and intensity of the RF energy or the wavelength and intensity of the optical energy. The control unit  701  optionally contains a processor  709  for monitoring and controlling various functions of the device. For example, the processor  709  may monitor the electrical impedance between the electrodes in the applicator  703 , and determine the temperature distribution in the vicinity of the target. The processor  709  may also determine the parameters of the treatment based upon the impedance measurements.  
         [0034]    [0034]FIG. 2 shows the applicator  703  in detail. The applicator contains a pair of electrodes  401  and  402  that apply RF energy to the skin. A light source  403  produces a light spectrum that is delivered to the skin surface by light guide  404 .  
         [0035]    In accordance with the method of the invention, the system shown in FIG. 1 is used to first apply optical energy to a target having a diameter for example of 2 mm. The optical energy may have an intensity from about 5 to about 100 Joules/cm 2  and may be applied from about 1 to 200 msec.  
         [0036]    The parameters of RF energy may have the following exemplary values:  
         [0037]    Frequency of the RF energy: from about 300 kHz to about 100 MHz.  
         [0038]    Output power of the RF energy from about 5 to about 200 W.  
         [0039]    Duration of the irradiation: from about 1 to about 500 msec.  
         [0040]    Pulse repetition rate: from about 0.1 to about 10 pulses per second.  
         [0041]    [0041]FIG. 3 shows a flow chart for a method of treating skin using the system shown in FIGS. 1 and 2. In step  300 , the applicator  703  is applied to the skin of an individual in the region of a target in the skin. In step  310  the light source  403  is activated so that the target is irradiated with optical energy from the light source  403  conducted through the optic fiber  404  to the target. In step 320 the irradiation with optical energy is terminated. RF energy is then applied to the skin (step  330 ). Finally, in step  340 , the application of RF energy is terminated.  
         [0042]    Referring now to FIGS. 4 and 5, a system for creating a temperature gradient between a skin target and the surrounding ski, in accordance with another embodiment of the invention is shown. An applicator  803 , to be described in detail below, contains a pair of RF electrodes  401  and  402 . The applicator  803  is adapted to be applied to the skin of an individual  805  in the region of a target. The control unit  801  includes a power source  808 . The power source  808  is connected to an RF generator  815  that is connected to the RF electrodes in the applicator  803  via wires in the cable  802 . The control unit  801  controls a refrigeration unit  812  that cools a fluid such as ethanol or water for cooling the applicator  803 . The cooled fluid flows  10  from the refrigeration unit  812  to the applicator via a first tube in the cable  802 , and flows from the applicator  803  back to the refrigeration unit via a second tube in the cable  802 . The control unit  801  has an input dice such as a keypad  810  that allows an operator to input selected values of parameters of the treatment, such as the frequency, pulse duration and intensity of the RF energy or the temperature of the coating fluid. The control unit  801  optionally contains a processor  809  for monitoring and controlling various functions of the device. For example, the processor  809  may monitor the electrical impedance between the electrodes in the applicator  803 , and determine the temperature distribution in the vicinity of the target. The processor  809  may also determine the parameters of the treatment based upon the impedance measurements.  
         [0043]    [0043]FIG. 5 shows the applicator  803  in, detail. The applicator contain a pair of electrodes  401  and  402  that apply RF energy to the skin. The housing and electrodes are cooled by fluid cooled by the refrigeration unit  812  that flows in a tube  408  between inlet  405  and outlet  406 . The inlet  405  and the outlet  406  are connected to the refrigeration unit  812  via the fist and second tubes in the cable  802 .  
         [0044]    [0044]FIG. 6 shows a flow chart for a method of treating skin using the system shown in FIGS. 4 and 5. In step  600 , the applicator  703  is applied to the skin of an individual in the region of a target in the skin. In step  610  cooling system  812  is activated so that the skin surrounding the target is cooled to a temperature below that of the target, RF energy is then applied to the skin (step  620 ). Finally, in step  630 , the application of RF energy is terminated.