Patent Publication Number: US-2010121259-A1

Title: Device and system for skin treatment

Description:
FIELD OF THE INVENTION 
     The present invention relates to a device, system and method for the removal of pigment from skin, and in particular, to such a device, system and method which non-invasively removes pigment through the application of fluid and vibrations to the skin. 
     BACKGROUND OF THE INVENTION 
     Unwanted skin pigmentation may take many forms and may arise from many different processes, some of which are natural while other such processes are artificial. A prominent example of an artificial process which results in skin pigmentation is tattooing. This process involves injection of colored pigment into small but deep holes in the skin, typically with needles. Frequently a subject who has a tattoo may wish to remove it. Other types of natural and artificial skin pigmentation may also be unwanted by the subject and so may be desirable to remove. 
     Pigment removal from skin is currently a difficult process which requires multiple treatments over an extensive period of time. For example, the state of the art treatment involves the use of lasers to remove pigment from the superficial layers of skin. The lasers must be applied at least five times over a period of about 6-8 months, such that the skin has sufficient time to heal between applications. Each application of the laser is painful and results in inflammation and swelling of the skin, accompanied by pain after treatment. The laser cannot remove colors which are similar to skin color, such as yellow or other colors which are not within the spectrum of the laser. Furthermore, side effects may occur, such as burning of the skin, or hypopigmentation (reduced skin color) or hyperpigmentation (increased skin color), all of which are cosmetically undesired. 
     Other methods of pigment removal include dermabrasion, in which the skin is abraded and hence removed, thereby also removing the pigment. Such treatment is very painful and may cause collateral damage to the skin, potentially resulting in further scarring. Cryosurgery may be used, to freeze a portion of the skin and hence to destroy it, although again this method is very invasive and destructive of the skin. The skin may also be removed by surgery but again this is likely to cause additional scarring and other cosmetic problems. 
     In an attempt to overcome the drawbacks of known treatments, other methods of pigment removal have been proposed. However, each suffers from many disadvantages. For example, U.S. Pat. No. 6,743,215 to Bernabei relates to a method of dermabrasion, accompanied by mechanical vibrations and the administration of a solution containing some type of pharmaceutical material for treatment of the pigmented area. However, this method suffers from the drawbacks described above, as dermabrasion is highly destructive of the skin and may cause additional scarring. 
     PCT Publication No. WO2004/009177 to Bernabei relates to the use of electrical pulses in order to cause skin to become permeable, followed by insertion of a solution containing a drug to the permeable skin. This method is suitable for drug delivery but is not suitable for pigment removal, since the skin is caused to become deeply permeable, such that treatment materials would become systemically absorbed. By contrast, pigment removal preferably only involves treatment of the superficial layers of the skin, rather than systemic treatment of the body. 
     SUMMARY OF THE INVENTION 
     There is an unmet need for, and it would be highly useful to have, a system, device and method for removing pigment from the skin which does not cause scarring, skin damage or additional skin complications. 
     There is also an unmet need for, and it would be highly useful to have, a system, device and method for removing pigment from the skin which is capable of removing pigment of any color without restriction. 
     There is also an unmet need for, and it would be highly useful to have, a system, device and method for removing pigment from the skin which more rapidly removes the pigmentation, particularly with fewer treatments and/or less time required for recovery of the skin between treatments. 
     The present invention overcomes these drawbacks of the background art by providing a system, device and method for non-invasively removing pigment from the skin through the application of fluid and vibrations to the skin. Preferably, the fluid is applied under pressure. The vibrations are also preferably at a high rate, up to and including ultrasonic rates. Optionally and more preferably, as described herein, the skin in the area of treatment is caused to protrude, for example through application of a vacuum. 
     The device preferably comprises a handle for being grasped, from which fluid is emitted, preferably by being sprayed. The handle is also preferably connected to a probe which vibrates and which is capable of applying mechanical vibrations to the area of skin to be treated. Preferably the probe length is between 5 cm to 20 cm while the probe. The handle is manipulated by the user in order to apply the fluid to the area of skin to be treated. The handle is preferably connected to a tube which is in turn connected to a container for containing the fluid. The fluid is pumped out of the container by a pump, which is also connected to the container and/or tube, or both (directly or indirectly). The pump is in turn preferably connected to a power source, which may optionally be a battery or an electrical outlet for example. The fluid in the container may also optionally be warmed or cooled for application. 
     The distal end of the probe preferably features a tip for being placed on the area of skin to be treated. This tip may optionally enable the user to more steadily and easily center the probe on the area of skin to be treated for example. The tip also preferably provides the vibrations for application to the area of skin to be treated, which are more preferably provided at a high rate, most preferably up to and including ultrasonic rates. Preferably the frequency used is above about 25 kHz and below about 40 kHz and most preferably in the range of 28 kHz to 32 kHz for example 30 kHz. The distal end of the probe is preferably either capable of being sterilized or is disposable. Most preferably the distal end of the probe is 1 mm to 20 mm in diameter or length. Most preferably the probe does not enter the skin while providing a treatment to a specific small area between 1 mm and 20 min. 
     According to preferred embodiments, the distal end of the probe features one or more outlets for the fluid, most preferably at least two or more fluid outlets. The probe handle also preferably features one or more buttons or other controls for controlling the rate of vibrations, the amount of fluid, whether fluid is applied (if the fluid is not provided continuously), and/or optionally temperature of the fluid, and/or pressure of the applied fluid. 
     The fluid may optionally and preferably consist of water alone and/or of an aqueous solution. The fluid may also optionally comprise a non-aqueous solution. The fluid may optionally comprise a drug or other treatment material, or a combination of drugs or treatment materials. 
     The fluid is preferably applied under pressure to the skin. Preferably, the fluid is provided through at least one and more preferably a plurality of fluid jets. The pressure and/or volume of the fluid being administered are each preferably adjustable, for example by providing a plurality of controls to the user. Fluid pressure produced by the jets and applied to the skin optionally and preferably is within the range of 25 to 75′ psig. Most preferably the fluid pressure does not exceed up to about 70 psig. The vibrations are also preferably controllable with regard to frequency, more preferably from about 20 kHz to about 40 kHz. More preferably vibration frequency is controlled to be more than 25 kHz and up to 40 kHz. Most preferably, the vibration frequency is within the range of 28-32 kHz, for example 30 kHz. 
     According to preferred embodiments of the present invention, there is provided a skin protruder for causing the portion of the skin to be treated to protrude. The protruder preferably lifts the portion the skin away from the tissues below. 
     The skin protruder preferably comprises a suction device for causing a vacuum to be applied to the portion of the skin to be treated. The device may optionally comprise a cup to be applied to the portion of skin to be treated, connected to a tube which is in turn connected to a pump or other device for inducing suction. For this exemplary embodiment, the previously described probe is preferably inserted through the cup such that the vacuum may be maintained, optionally and preferably through a sleeve which maintains the seal. 
     Alternatively, a cup or other type of cover may optionally be applied without the application of a vacuum to the skin, for example in order to protect the surrounding skin from contacting the fluid and/or to keep the area of skin to be treated clean and hygienic. Furthermore, such a cover may optionally be applied to protect the user who is applying the treatment from contacting the fluid and/or biological tissue from the subject of the treatment, wherein tissue may comprise liquid and/or solid material. 
     According to other preferred embodiments of the present invention, if a cover is used (with or without a protruder to cause the skin to protrude), optionally and preferably a suction device is included to remove fluid being applied under the cover. The suction device may optionally be separate from the device for applying a vacuum; either or both may optionally be present on the probe or as separate device(s). 
     According to still other preferred embodiments of the present invention, there is provided a control center for controlling the frequency of the vibrations, and/or the amount of fluid and/or pressure of the fluid being provided. The control center also preferably enables the user to select the strength of protrusion of the skin (ie the extent to which it protrudes), for example by controlling the amount of vacuum applied to the area of the skin to be treated. These functions of the control center are optionally and preferably implemented through the use of suitable electronic components as is known in the art. 
     Optionally and preferably, the control center may comprise one or more programmed treatment routines, which may optionally be pre-programmed or alternatively programmed by the user, for automatically performing a particular type of treatment. Optionally, the control center comprises a display as is known and accepted in the art. Optionally, the display provides a user with the ability of selecting a programmed treatment or customizing a treatment routine. 
     As described herein, the term “pigment” may optionally and preferably include, but is not limited to, pigments which are artificially introduced (for example through tattooing), pigmentation which is the result of wound healing or scarring (or any other damage to the skin), or any naturally occurring pigmentation, including but not limited to age spots, freckles, port wine stains and other birthmarks, and the like. 
     Without wishing to be limited by a single hypothesis, the present invention permits the use of less aggressive treatment than methods of the background art. In turn, this permits the skin to heal more rapidly. Without wishing to be limited in any way, it is believed that the present invention has at least the following advantages: ability to remove any type of pigment without being limited by pigment color or any other limitation; non invasive; reduced likelihood of scarring; reduced time between successive treatments (due to shortened skin healing time); reduction of time from initial removal until complete disappearance; optional use of acid or other treatment solutions having low concentrations (thereby reducing the potential for side effects); parallel control of pulse frequency and pressure, and application of the fluid; optionally enclosing the working area (through the application of a cup or other cover) such that the surrounding skin does not come into contact with the solution/acids and also preventing the user of the device from coming into contact with biological liquids and/or solids; keeping the working area sterile and hygienic through the optional use of an enclosure for the working area; ability to change the profile of the fluid application according to the location of the treatment area; increased ease of use, including also for low skill or non-skilled users; low cost, particularly as compared to laser treatment. 
     The present invention differs from the solutions proposed in the art in many ways. One non-limiting example of such a difference relates to spraying fluid under pressure. Another non-limiting example of such a difference is the avoidance of needles for puncturing the skin and/or other invasive methods. 
     Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The materials, methods, and examples provided herein are illustrative only and not intended to be limiting. 
     Implementation of the method and system of the present invention involves performing or completing certain selected tasks or stages manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of preferred embodiments of the method and system of the present invention, several selected stages could be implemented by hardware or by software on any operating system of any firmware or a combination thereof. For example, as hardware, selected stages of the invention could be implemented as a chip or a circuit. As software, selected stages of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In any case, selected stages of the method and system of the invention could be described as being performed by a data processor, such as a computing platform for executing a plurality of instructions. 
     It should be noted that optionally any device featuring a data processor and/or the ability to execute one or more instructions may be described as a computer, including but not limited to a PC (personal computer), a server, a minicomputer, a cellular telephone, a smart phone, a PDA (personal data assistant) or a pager. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The invention is herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present invention only, and are presented in order to provide what is believed to be the most useful and readily understood description of the principles and conceptual aspects of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for a fundamental understanding of the invention, the description taken with the drawings making apparent to those skilled in the art how the several forms of the invention may be embodied in practice. 
       In the drawings: 
         FIG. 1A-B  are a schematic diagrams of optional embodiments of a system according to the present invention,  FIG. 1A  according to a first exemplary embodiment and  FIG. 1B  according to a second exemplary embodiment. 
         FIG. 2  is a schematic diagram of a system according to the present invention according to a second exemplary embodiment. 
         FIG. 3A-E  are schematic diagrams of bottom views of the probe&#39;s distal face according to optional embodiments of the present invention. 
         FIG. 4A-I  are schematic diagrams of the probe and treatment area according to an optional embodiments according to the present invention. 
         FIG. 5  shows a flowchart of an exemplary, non-limiting method according to the present invention for pigment removal. 
         FIG. 6  is a photograph showing all eight sites after tattooing (introduction of pigment) prior to treatment according to an optional embodiment of the present invention. 
         FIG. 7  is a photograph showing four sites following one treatment according to the present invention. 
         FIG. 8  is a photograph of two of the four sites of  FIG. 7  following a second treatment according to the present invention. 
         FIG. 9  is a photograph showing the entire area of skin as in  FIG. 6  after the second treatment was applied according to an optional embodiment of the present invention. 
         FIG. 10A-C  depicts close up comparative views of before and after treatment according to an optional embodiment of the present invention. 
         FIG. 11  A-D are photographs of histological slides of the skin following treatment according to an optional embodiment of the present invention. 
     
    
    
     DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     The present invention is of a system, device and method for removing pigment from the skin through the application of fluid and vibrations to the skin. The fluid may optionally and preferably be applied continuously or alternatively may optionally be provided discontinuously or intermittently, optionally and preferably according to manual control. The device preferably comprises a handle for being grasped, from which fluid is emitted. The handle is manipulated by the user in order to apply the fluid to the area of skin to be treated, wherein the fluid is preferably under pressure. Most preferably the fluid is pumped under pressure, optionally providing a fluid pressure from about 25 psig to about 75 psig, most preferably the fluid pressure is about 70 psig. The handle is preferably connected to a probe which vibrates and which is capable of applying mechanical vibrations to the area of skin to be treated. The vibrations are preferably at a high rate, more preferably up to and including ultrasonic rates. Preferably, the vibration frequency is more than about 25 kHz and below about 40 kHz, most preferably in the range of about 28 kHz to about 32 kHz, providing for a probe that vibrates at a frequent of about 30 kHz for example. Optionally the probe is between 5 cm and 20 cm in length. The handle is also preferably connected to a tube which is in turn connected to a container for containing the fluid. The fluid is pumped out of the container by a pump, which is also connected to the container and/or tube, or both (directly or indirectly). Most preferably the fluid is pumped under pressure, optionally providing a fluid pressure from about 25 psig to about 75 psig; optionally and most preferably the fluid pressure is about 70 psig. The pump is in turn preferably connected to a power source, which may optionally be a battery or an electrical outlet for example. 
     The distal end of the probe preferably features a tip for being placed on the area of skin to be treated. This tip may optionally enable the user to more steadily and easily center the probe on the area of skin to be treated for example. Optionally, the probe tip is optionally 1 mm to 20 mm in diameters. The tip also provides the vibrations for application to the area of skin to be treated. The distal end of the probe is preferably either capable of being sterilized or is disposable. 
     According to preferred embodiments, the distal end of the probe preferably features one or more outlets for the fluid. The handle also preferably features one or more buttons or other controls for controlling the fluid amount, whether fluid is applied (if not applied continuously) and/or pressure of the fluid, as well as preferably enabling control of the rate of vibrations. 
     The fluid may optionally and preferably consist of water alone and/or of an aqueous solution. The fluid may also optionally comprise a non-aqueous solution. The fluid may optionally comprise a drug or other treatment material, or a combination of drugs or treatment materials. The drug or treatment material may optionally comprise one or more of an alpha hydroxy acid or a beta hydroxy acid, including but not limited to one or more of salicylic acid, glycolic acid or lactic acid, or a combination thereof. 
     The fluid is preferably applied under pressure to the skin. Preferably, the fluid is provided through at least one and more preferably a plurality of fluid jets. The pressure and/or volume and/or optionally the temperature of the liquid are each preferably adjustable, for example by providing a plurality of controls to the user. 
     According to preferred embodiments of the present invention, there is provided a skin protruder for causing the portion of the skin to be treated to protrude. The protruder preferably lifts the portion the skin away from the tissues below. Without wishing to be limited by a single hypothesis, it is believed that lifting the skin causes it to become stretched, hence rendering it more permeable or at least sensitive to the treatment. With such stretching, it is believed that one or more treatment parameters may be altered, preferably through reduction, including but not limited to reducing the length of each treatment, the total number of treatments, the pressure for each pulse, the frequency of pulses, or the concentration of the drug or other treatment material included in the solution (if any), or a combination thereof. 
     The skin protruder preferably comprises a suction device for causing a vacuum to be applied to the portion of the skin to be treated, which may optionally be located on the probe or which alternatively may optionally be separate from the probe. The device may optionally comprise a cup to be applied to the portion of skin to be treated, connected to a tube which is in turn connected to a pump or other device for inducing suction. For this exemplary embodiment, the previously described probe is preferably inserted through the cup such that the vacuum may be maintained, more preferably with a sleeve for maintaining the vacuum. Optionally and preferably, the cup features a seal for sealing the edge of the cup to the skin. 
     Alternatively, a cup or other type of cover may optionally be applied without the application of a vacuum to the skin, for example in order to protect the surrounding skin from contacting the fluid and/or to keep the area of skin to be treated clean and hygienic. Furthermore, such a cover may optionally be applied to protect the user who is applying the treatment from contacting the fluid and/or biological tissue from the subject of the treatment. 
     According to other preferred embodiments of the present invention, if a cover is used (with or without a protruder to cause the skin to protrude), optionally and preferably a suction device is included to remove fluid being applied under the cover. The suction device may optionally be separate from the device for applying a vacuum. 
     For either embodiment, the cup or cover is preferably transparent or translucent for viewing the area of skin to be treated. 
     According to still other preferred embodiments of the present invention, there is provided a control center for controlling the frequency of the vibrations, and/or the amount of fluid and/or pressure and/or optionally the temperature of the fluid provided. If more than one such fluid is applied (for example, a fluid containing a treatment material and another fluid which does not contain such a material), then preferably the control center allows the user to select the rate of application of each fluid separately. The control center also preferably enables the user to select the strength of protrusion of the skin (ie the degree to which it protrudes), for example by controlling the amount of vacuum applied to the area of the skin to be treated. These functions of the control center are optionally and preferably implemented through the use of suitable electronic components as is known in the art. 
     Optionally and preferably, the control center may comprise one or more programmed treatment routines, which may optionally be pre-programmed or alternatively programmed by the user, for automatically performing a particular type of treatment. For example, one or more routines may optionally be provided for different types of applications of fluid according to the nature of the pigment (for example, whether it is a tattoo or a naturally occurring pigmentation) and/or the nature of the skin of the user (thick or thin, sun damaged, young or old, etc) and/or according to the number of the treatment (ie whether the treatment is the first treatment, second treatment and so forth) and/or according to the response of the skin to a previous treatment. Such programmed routines may optionally be programmed onto some type of processor and memory, optionally in some type of computational device. 
     The principles and operation of the present invention may be better understood with reference to the drawings and the accompanying description. 
     Referring now to the drawings,  FIG. 1  is a schematic diagram of a system according to the present invention according to a first exemplary embodiment. A system  100  features a probe  1 , which preferably delivers fluid to the area of skin to be treated  102 , for example through one or more tubes (not shown). If present, optionally suction is also delivered through probe  1 , again for example through one or more tubes (not shown). 
     The distal end of probe  1  preferably features one or more fluid outlets  2 , of which two are shown for the purpose of illustration only and without any intention of being limiting. If two such outlets  2  are present, preferably each outlet  2  is disposed on an opposing side of the distal end of probe  1 . If more than two such outlets  2  are present, preferably outlets  2  are disposed evenly around the distal end of probe  1 . Each fluid outlet  2  preferably sprays fluid onto skin area  102  for treatment. The size of fluid outlet  2  is optionally and preferably determined according to the desired energy of the fluid to be applied, which in turn is dependant upon a combination of parameters, including but not limited to, the diameter of fluid outlet  2 , the pressure of spraying of the fluid and the distance from fluid outlet  2  to skin area  102 . Each fluid outlet  2  may also optionally comprise a plurality of holes (or optionally protrusions) for emitting the fluid, preferably having a configuration for altering the pressure or velocity of fluid as emitted. 
     The distal end of probe  1  preferably also features a probe head  3 . Probe head  3  may optionally be made from metal or any other sterilizable material. Alternatively or additionally, probe head  3  may optionally and preferably be disposable. Probe head  3  may optionally be placed in contact with skin area  102 , for example to enable the user (not shown) to more readily maintain contact with skin area  102  and/or to ensure proper placement of the distal end of probe  1 . Probe head  3  may also optionally itself vibrate at a rate of from about 20 kHz to about 40 kHz. 
     Probe head  3 , as described in greater detail below, may optionally and preferably vibrate due to vibrations from a vibration source (not shown), optionally and more preferably according to a piezoelectric effect (or rather transduction of such an effect). Such a general effect is known in the art for dental tools for cleaning teeth, for example. U.S. Pat. No. 4,038,571 to LITTON INDUSTRIAL PRODUCTS, issued on Jul. 26, 1977 and hereby incorporated by reference as if fully set forth herein, describes a device which uses a piezoelectric crystal for converting electrical energy into mechanical vibrations which are transmitted to a dental workpiece for use in cleaning teeth. As described in the patent, a piezoelectric material, such as a crystal for example (a non-limiting example of which is a lead zirconate-lead titanate ceramic crystal), is supplied with electrical energy. The piezoelectric material then vibrates according to the amount and/or frequency of energy supplied and the inherent properties of the piezoelectrical material itself. The vibrations of the piezoelectric material then causes probe head  3  to vibrate, either directly or through some type of connector or transducer as described in greater detail below. 
     The function of system  100  is preferably controlled through a control center  4 , which contains a pump for pumping the fluid through probe  1  to each outlet  2  (not shown). Control center  4  optionally and preferably includes a pump for providing suction (also not shown), as well any electrical components for controlling the function of system  100  as described herein. The fluid itself is preferably contained in a container  8 , which is fluidly connected to probe  1  through control center  4 , for being pumped out by the pump in control center  4 . The fluid in container  8  may optionally be warmed or cooled as is known in the art. 
     Control center  4  also preferably features a frequency control switch  5  which more preferably includes a digital display and control, for the controlling the frequency of vibration of probe head  3 . Probe head  3  is optionally caused to vibrate according to any mechanism or means that are known in the art, preferably according to known ultrasonic mechanisms or means. 
     Control center  4  also optionally and preferably features a suction control switch  6  including a digital display and control, for controlling suction applied to skin area  102  as described in greater detail below. 
     Control center  4  also optionally and preferably features a fluid flow control switch  7  including a digital display and control, for controlling the volume and/or pressure of fluid to be delivered. 
     Control center  4  features a power source  9 , shown herein as an electrical cable for being connected to an electrical outlet, although of course any suitable power source may optionally be used for powering the pump(s) and controls of system  100 . 
     System  100  preferably features a connector  13  for connecting probe  1  to control center  4 . Connector  13  preferably includes a tube for carrying fluid to probe  1 , an electrical connection for connecting probe  1  to control center  4 , and also may optionally include a tube for providing suction to probe  1 . Probe  1  also preferably features at least one control button or switch  12 , for enabling the user (not shown) to control at least one function of probe  1 . As shown an “L” button preferably enables the user to control whether liquid is being sprayed from outlet(s)  2  or not. Each control button  12  is preferably electrically connected to control center  4  through connector  13 , for example for turning a pump on or off, or for opening/closing a valve for permitting fluid to flow through connector  13  to probe  1  (not shown). 
     According to preferred embodiments of the present invention, system  100  features a protruder  104  for causing skin area  102  to protrude. Protruder  104  is preferably used to cause skin area  102  to be stretched or pulled; without wishing to be limited by a single hypothesis, it is believed that such stretching increases the sensitivity and/or permeability of the skin to treatment. Protruder  104  preferably features the application of vacuum through a cover  10 , which may optionally be shaped like a cup or dome as shown. Cover  10  is preferably transparent or at least translucent, in order for the user to be able to view skin area  102 , and may be made from any suitable material, including but not limited to glass, plastic, silicon, rubber, flexible composite materials and the like. Cover  10  preferably features a seal for sealing the edge of cover  10  to skin area  102  (not shown, see  FIG. 3 ). 
     For this embodiment, system  100  also preferably features a sealing sleeve  11  through which probe  1  is inserted in order to provide a seal for the vacuum and to maintain the vacuum. Sleeve  11  is preferably made of a flexible material such as rubber or plastic to permit probe  1  to be maneuvered. More preferably, sleeve  11  provides a working angle of 60-120 degrees. Sleeve  11  may optionally be configured as an accordion or bellows unit of pleated material, for example. 
     Also for this embodiment, probe control button  12  also preferably includes a button for controlling suction, labeled “S” in  FIG. 1  for the purpose of illustration only and without any intention of being limiting. 
     Optionally and preferably, in addition to vacuum, the distal end of probe  1  system  100  may also include suction for removing fluid sprayed from outlet(s)  2  (see  FIG. 3 ). Such suction may be applied in addition to the vacuum or in place of the vacuum, for example if cover  10  is used but without the application of a vacuum to skin area  102 . Cover  10  may optionally be used without vacuum to maintain cleanliness and hygiene of the area, to prevent fluid from contacting skin other than at skin area  102 , and also to protect the user who is operating system  100  from contacting the fluid and/or biological tissue. 
       FIG. 1B  is a schematic diagram of a system according to the present invention according to a second exemplary embodiment. Components with the same numbers have the same or similar function as shown with regard to FIG.  1 A; hence the function of the system of  FIG. 1B  is very similar if not identical, except that there is no device for applying suction or a vacuum. There is also no button “S” for controlling suction; rather button  12  controls whether fluid is sprayed or not. 
       FIGS. 2A and 2B  shows a detailed view of control area  4  depicted in  FIG. 1A-B . Control unit  220  comprises control center  224 , at least one or more fluid source containers  228 . Preferably, control unit  220  further comprises at least one or more pumps (not shown). Optionally at least one or more pumps (not shown) is a fluid pump preferably able to create a fluid pressure between about 25 psig and to about 75 psig. Optionally, at least one or more pumps (not shown) is an air pump, preferably able to create a vacuum suitable for treatment according to the present invention.  FIG. 2B  provides a close up view of control center  224 . Preferably, control center  224  comprises electronics as known and accepted in the optionally powered by a battery or mains power source (not shown). Preferably control center  224  comprises components as known and accepted in the art able to provide controllable vibrations preferably in the high frequency range, more preferably above about 25 kHz and below about 40 kHz, and most preferably in the frequency range of about 28 kHz to about 32 kHz. As shown in greater detail below, and also as previously described, optionally and preferably such vibrations are provided according to a piezoelectric effect. 
     Preferably, control center  224  comprises at least one or more display units  232 . Preferably, display  232  provides an interface through which a user may interface, communicate and control the functioning of control center  224 . Control center  224  may optionally comprise relatively simple electronics for providing such control or alternatively may comprise a processor, memory and so forth, for example as implemented through a computer, for such control. Optionally, display  232  provides a user with the ability of selecting a programmed treatment or customizing a treatment routine programmed into control unit  220 . Preferably, control center  224  further comprises controls  235 ,  236  and  237  to control treatment parameters according to the present invention, for example including but not limited to vibration frequency, liquid delivery, liquid pressure, suction strength. 
     Control center  224  preferably features a frequency control switch  235  for the controlling the frequency of vibration used in the treatment protocol according to the present invention. Optionally and preferably the actions of control  235  is made visible on display  232 . 
     Control center  224  also optionally and preferably features a suction control switch  236  for controlling the applied suction according to an optional treatment protocol of the present invention. Optionally and preferably the actions of control  235  is made visible on display  232 . 
     Control center  224  also optionally and preferably features a fluid flow control switch  237  preferably for controlling the volume and/or pressure of fluid to be delivered according to an optional treatment protocol of the present invention. Optionally and preferably the actions of control  235  is made visible on display  232 . 
       FIG. 3A  shows a bottom view of an exemplary device according to  FIG. 1A , specifically of the distal end of probe  1  having a probe face  310 . A seal  300  is shown for sealing cover  302  to the area of skin to be treated (not shown; see  FIG. 1A ). Seal  300  may optionally be a silicon seal or any other type of sealing material as known and accepted in the art. Outlets  306  are shown, as is probe head  303 . A suction outlet  308  is also shown, for providing suction, for example for applying a vacuum or alternatively for sucking out debris or liquid sprayed from outlets  306 . Preferably sleeve  304  provides further compartmentalization or focus on the treatment point within the treatment area. Preferably sleeve  304  improve focus and visibility during treatment. 
       FIG. 3B  shows another bottom view of another optional embodiment of the distal end of probe  1  having a probe face  320 . As shown, suction  308  is placed at either side of the distal end of probe  1 , while a plurality of outlets  306  are placed centrally, preferably arranged around probe head  303 . Sleeve  304  and seal  300  are again shown as for  FIG. 3A . Preferably sleeve  304  provides further compartmentalization or focus on the treatment point within the treatment area. Preferably sleeve  304  improve focus and visibility during treatment. 
       FIG. 3C  shows yet another bottom view of another embodiment of the distal end of a probe having a probe face  330  according to an optional embodiment of the present invention. Again seal  300  is provided, which is maintained through a suction protruder  308 . There is also preferably provided a plurality of internal seal units  332 , each of which preferably comprises an internal suction/evacuation device  336  and an internal fluid spray outlet  334 . Optionally individual fluid spray outlet  334  preferably operates in a pulsatile manner, more preferably according to manual control of the user (not shown) as depicted in  FIG. 1A-B . Optionally individual suction device  336  then removes the sprayed fluid. 
       FIG. 3D  shows another bottom view of another optional embodiment of the distal end of probe  1  having a probe face  340 . Probe face  340  optionally comprises treatment head face  342  that lies within suction cup  300  that acts to seal the treatment area.  FIG. 3E  shows a close up view of treatment head face  342  in greater detail. As shown treatment head face  342  comprises sleeve  344 , a plurality of suction nozzles  348  and a plurality of fluid jet nozzles  346 , preferably arranged centrally around probe head  343 . 
     Sleeve  304  and seal  300  are again shown as for  FIG. 3A . Preferably sleeve  304  provides further compartmentalization or focus on the treatment point within the treatment area. Preferably sleeve  304  improve focus and visibility during treatment. 
       FIG. 4A  shows an illustrative device according to the present invention, which may optionally be implemented with either of the systems shown in  FIG. 1  or  2 . 
     Probe  1  is again shown, with control buttons  12 , connector  13  and probe head  3 . Outlets  2  are optionally implemented as protruding nozzles as shown, rather than being implemented only as holes or openings. Suction  312  is also shown as optionally be implemented through a protruding tube. The operation of probe  1  may optionally be as described above. 
       FIG. 4B  is a close up view of an optional embodiment of the distal end of probe  1  of  FIG. 4A . Probe  401  preferably comprises a housing  409 , flexible portion  11  (as previously described), jets  402 , suction  404  and vibrating head  406 . 
       FIG. 4C  depicts an optional embodiment of the probe  410  according to the present invention to remove a tattoo over an area of skin  420 . Skin area comprises dermis layer  414  above which lies the epidermis  416 , above which lies the skin surface  418 . The tattoo to be removed is incorporated within the dermis layer  414  in the form of ink  412 . Probe  410  according to an optional embodiment of the present invention functions to displace ink  412  from the dermis  414  allowing it to be removed through the epidermis  416  and eventually out through the skin surface  418 . 
     Probe  410  preferably comprises suction cup  408 , a plurality of fluid jet nozzles  402 , suction tube  404 , and treatment head  406 . Optionally probe  410  is between 5 cm to 20 cm long. Preferably, suction cup  408  optionally seals the treated skin area  400  preferably providing suction to the larger overall area being treated as well as the area specifically treated with treatment head  406 . Preferably treatment head  406  is 1 mm to 20 mm in diameter. Suction tube  404  preferably provides suction over treatment area  400  within suction cup  408 , preferably allowing treatment head  406  to lift the skin at the treatment point bringing the underlying ink  412  closer to treatment head  406 . Preferably, treatment head  406  is vibrating at a frequency that is more than 25 kHz and lower than 40 kHz, most preferably between 28 kHz and 32 kHz, for example 30 kHz. Preferably while treatment head  406  treats treatment area  400  a fluid jet is applied the treatment area using a plurality of fluid jet nozzle  402 . Optionally, fluid jet nozzle  402  delivers fluid at a pressure that is below about 75 psig and more preferably between about 25 psig and 70 psig. 
       FIG. 4D  depicts a close up view of  FIG. 4C  showing the distal end of probe  410  and suction cup  408 . 
       FIG. 4E  depicts an optional embodiment of a probe  450  comprising a probe shaft  460 , control buttons  462 , and a probe distal treatment head  452 . Treatment head  452  preferably comprises probe face  454 , a plurality of suction tube nozzles  456  and a plurality of fluid jet nozzles  458 . Optionally, suction tube nozzles  456  provides suction to the treatment area allowing a user to protrude the skin toward treatment head  452  and in particular to probe face  454 , while also allowing a user to maintain a clean treatment area clear of debris. Most preferably, probe face  454  provides the treatment area with vibration frequency in the ultrasound range for example about 30 kHz. Most preferably vibration frequency is maintained within the range of about 28 kHz to about 32 kHz. Preferably, fluid jet nozzle  458  provides the treatment area with a fluid, preferably at a fluid pressure in the range of about 25 psig to about 75 psig, most preferably about 70 psig.  FIG. 4F  depicts a close up view of probe treatment head  452  wherein the plurality of suction nozzle  456 , the plurality of fluid jet nozzle  458  and probe face  454  are more clearly visualized. 
       FIG. 4G  depicts a sagittal sectional view of probe  450  of  FIG. 4E  applied to a treatment area  400 . Treatment area  400  is defined by suction cup  472  comprising the distal end of probe  450  and treatment head  452 . Optionally, suction cup  472  is made of a sealable material for example including but not limited to silicone, rubber or the like material known and accepted in the art able to create a vacuum over treatment area  400  that preferably protrudes treatment area  400  from underlying tissue (not shown) toward treatment head  452 . Preferably, the point  401  lying directly beneath treatment head  452  receives the treatment according to an optional embodiment of the present invention. Preferably treatment head  452  vibrates treatment face  454  at a frequency between 28 kHz and 32 kHz while a plurality of fluid jet nozzle  458  provides a pressurized fluid delivered through a fluid tube  468  that is linked to control unit (not shown) similar to that depicted in  FIG. 2  through tube  470 . Preferably, treatment head  452  is further provided with suction originating at a control unit (not shown) via tube  470  that leads through to suction tube  466  and delivered to treatment point  401  through suction nozzle  456 . Optionally, fluid delivery or suction delivery may be controlled with control buttons  462 .  FIG. 4H  provides a close up view of the treatment area  400  and treatment point  401 . Arrows  474  depicts the direction of fluid flow within treatment area  400 . Fluid flow depicted by arrows  474  depict the optional air flow creating the vacuum within treatment area  400  or optionally depict the flow of a liquid fluid or debris away from treatment point  401  and treatment area  400 . 
       FIG. 4I  shows a close-up, partially cut-away view of probe  450  of  FIG. 4E . As shown, removal (for the purposes of illustration only) of a portion of probe shaft  460  at cut-away  480  provides a view of internal components of probe  450 . These internal components optionally include but are not limited to a rod  482  for transducing the vibrations from a piezoelectric material as previously described to treatment head  452 . Rod  482  may optionally be constructed of any suitable material, such as a metal or metal composite for example. Preferably the material is selected so as to provide a compound resonator responsive to the frequency of vibrations of the piezoelectric material itself. 
     A tube  486 , of which a plurality is preferably provided as shown, optionally and preferably supplies fluid to each fluid jet nozzle  458 . A suction tube  488 , of which a plurality is preferably provided as shown, optionally and preferably supplies force to each suction nozzle  456 . 
       FIG. 5  depicts an optional method according to the present invention for pigment removal, for example for removing a tattoo. In stage  1  the area to be treated is identified. In stage  2  based on the parameters of the treatment the treatment parameters optionally including but not limited to vibration frequency, fluid jet pressure, and fluid solution are defined and loaded onto the system according to the present invention. In stage  3 , the treatment is initiated over the treatment are optionally and preferably by placing the suction cup over it to create an appropriate seal and suction. In stage  4  the treatment head is applied to at least a portion but preferably the whole of the treatment area, optionally point by point such that the full pigmented area is treated uniformly. Optionally, the timing of fluid provision (whether pulsed, continuous or intermittent), vibrations and suction, and frequency thereof, is adjustable according to any combination of these forces and parameters. For example, fluid may optionally be provided with the vibrations, between application of vibrations, with or between application of suction, and so forth, more preferably as determined by the practitioner applying the treatment. 
     In stage  5  the treatment area is evaluated. Optionally at stage  5  the treatment is assessed wherein a plurality of options are preferably available. For example, treatment may be evaluated as being completed there for a user would proceed to end the treatment at stage  6 . Optionally, the treatment may be reverted to stage  2  or stage  3  depending on the completeness of the applied treatment. For example, if the evaluation process reveals that the treatment parameters require adjustment, then they will be adjusted at stage  2  and continued from there. Optionally if the evaluation determined that the treatment was incomplete then the treatment would optionally be reinitiated at stage  3 . At stage  6  the treatment is completed for the chosen treatment area. Optionally, a new treatment area may be evaluated, in which case the treatment method returns to stage  1  to evaluate the new treatment area. 
     Experimental Example 
     The above described device, system and method of the present invention were tested experimentally in order to show their efficacy. The device was implemented according to a similar embodiment as for  FIG. 1B . The objective was defined as testing the ability to perform complete removal of a tattoo (skin pigmentation/coloration) without damaging the skin. Prior to commencing the experiment successful removal was defined as complete removal of the mark without affecting skin texture. 
     The experimental procedure was approved and in accordance with the ethics committee on experimentation on animals (according to NIH standards), and with its prior approval. 
     Materials and Methods 
     A male pig, of the large white type mixed with the Ladrance type, weighting 15 kg, was acclimated for 1 week following its arrival to the holding area. 
     Food and Animal Care 
     The pig was fed twice daily with the commercially available product AMBAR and was allowed to drink freely ad-libitum. 
     Anesthesia 
     The pig was anesthetized with a combined IM (intra-muscular) shot containing: 15 mg/kg body weight of Ketamine with 2 mg/kg body weight Xylazine. Following confirmation of complete anesthesia, an endotracheal tube was inserted into trachea of diameter number 6. The outer portion of the pipe was connected to an automatic gas anesthesia machine using 2%-3% Isoflurane mixed with oxygen. 
     Creation of Skin Pigmentation 
     A hand held animal tattoo device was used to create the pigmentation. Blue ink was inserted into the depths of the dermis layer with a special needle. Tattoos were created in 8 locations along either side of the pig&#39;s back. 
     The pig was disconnected from the gas anesthesia machine and allowed to recover in the holding pen. The pig was kept in recovery for a period of 6 weeks following the procedure, allowing enough time, according to reports in the literature, for the pigment to sufficiently associate with macrophage cells in the tissue (which is believed to be the mechanism through which the pigment is permanently maintained in the skin). 
     Initial Treatment Procedure 
     Following 6 weeks the pig was anesthetized once more following the same protocol. The device of the present invention was used on 6 of the 8 locations tattooed. A solution containing 2% salicylic acid was used, although optionally another material such as glycolic acid, lactic acid, or a combination thereof may be used. This low concentration of salicylic acid was used because it is described in the literature as being useful for cleaning the skin in sensitive areas and does not drastically damage the skin. As a precautionary method, the antibiotic Cefazolin 750 mg was administered intravenously, to prevent any potential infection. The pig was then returned to his pen and observed for a 3 week period. The second treatment procedure was done undertaken following the skin&#39;s full recovery. 
     Secondary Treatment Procedure 
     Following 3.5 weeks from the first procedure, the pig was anesthetized as described above. The device was used on 4 tattoo sites alone. At this stage antibiotics were not used. 
     The pig was returned to the pen and follow up observation was performed including photographs of the treated sites, from both the initial and secondary procedures. 
     End of the Experiment 
     Following euthanasia all 8 procedural sites were excised and taken for histology/pathological testing. For euthanasia, the pig was first anesthetized as described above followed by an IV injection of Pentobarbitone Sodium 135 mg/kg of body weight. 
     Results and Conclusions 
     Of the eight tattooed sites, six were treated while two served as controls. Two of the treated sites underwent the initial procedure alone, while the remaining four sites were treated with the second (and final) treatment. The treatment was conducted with vibrations at the rate of about 30 kHz; the water was administered at between 25 to 70 psig.  FIG. 6  shows all eight sites after tattooing (introduction of pigment) but before treatment. 
     Following one or two treatments, changes in skin texture were not observed. No indication of scarring was found. No permanent damage was caused to the epidermis; any damage seen was temporary and was completely regenerated.  FIG. 7  shows four sites after one treatment (the four treated sites appear on the left).  FIG. 8  shows two of the four sites after two treatments.  FIG. 9  shows the entire area of skin after the second treatment was applied; the four sites on the right were treated twice and show a nearly complete eradication of the pigment. On the right, the bottom two sites (including one square and the number “one”) were not treated, while the top two sites were treated once. 
     After initial treatment alone, separation of pigment from the macrophage cells removal was estimated to be 40%, as 40% of the pigment was estimated to have been removed. Following the second treatment, removal was estimated at 70%-90%.  FIG. 10  shows a comparative look at before and after photographs following treatment at different states.  FIG. 10A  depicts photographs of tattoos in the control group before treatment while  FIG. 10D  depicts the control group&#39;s tattoo following treatment.  FIG. 10B  is a photograph of one of the tattoos prior to treatment, while  FIG. 10E  depicts the same tattoo following a first treatment according to the present invention, resulting in about 30% to 40% pigmentation removal.  FIG. 10C  is a photograph of one of the tattoos prior to any treatment, while  FIG. 10E  depicts the same tattoo following a second treatment according to the present invention, resulting in about 80% to 90% removal of the original tattoo. 
       FIG. 11  further shows the results of the histological study following the end of the experiment.  FIG. 11A  shows a histological section of the control group prior to treatment according to the present invention. The epidermis layer  1002  and the dermis layer  1004  where the ink  1006  is embedded within dermis layer  1004  below the epidermis  1002 . 
       FIG. 11B  depicts a histological section following a single treatment according to the present invention,  1008  depicts the remaining ink within the dermis  1004 .  FIGS. 11C and 11D  show the epidermis  1002  and dermis  1004  following a second treatment according to the present invention where the amount of ink  1012  is reduced and dispersed closer to the transition area between the dermis  1004  and epidermis. 
     Thus, it can be seen that the non invasive procedure according to the present invention does not affect the skin texture, and causes extensive and efficient removal of the pigment in a short period of time with very high efficiency, minimal damage to the skin and also rapid recovery. 
     While the invention has been described with respect to a limited number of embodiments, it will be appreciated that many variations, modifications and other applications of the invention may be made.