Abstract:
A method and system for wrinkle reduction. The method includes the steps of positioning and applying a patch to skin of a consumer and adhesively securing the patch to the skin. A chemical composition on the patch includes both active ingredients and adhesive. A pair of electrodes are connected to a battery-driven, microprocessor-based controller. A current is applied through the electrodes in the patch for a selected lime. The chemical composition in the patch is propelled into the consumer through use of the current in order to relax the skin or the consumer. The patch is removed and any residue of the chemical composition is massaged into the skin.

Description:
INCORPORATION BY REFERENCE TO ANY PRIORITY APPLICATIONS 
       [0001]    Any and all applications for which a foreign or domestic priority claim is identified in the Application Data Sheet as filed with the present application are hereby incorporated by reference under 37 CFR 1.57. 
         [0002]    This application is a continuation of U.S. patent application No. 12/970,224 filed Dec. 16, 2010, which claims priority to U.S. Provisional Patent Application Ser. No. 61/288,088, filed Dec. 18, 2009, both are incorporated in their entireties herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0003]    1. Field of the Invention 
         [0004]    The present invention relates and is directed to a process or method of use and a system including a disposable patch to treat wrinkles and fine lines with a chemical composition administered by iontophoresis. 
         [0005]    2. Prior Art 
         [0006]    There are various known procedures and various known chemical compositions for treating, reducing or preventing fine lines or wrinkles of the facial skin. It is known that moisturizers containing amino acids play a significant role in skin care by increasing skin elasticity and smoothing the skin. In addition, anti-aging active agents are known to change the skin condition by smoothing and tightening. 
         [0007]    Chemical compositions may be administered topically, such as lotions, or administered through transdermal patches. Additionally, chemical compositions may be administered by direct injection. Chemical compositions presently available include those which moisturize the outer skin or epidermis. Other compositions tend to promote cell growth in the skin. Other treatments of wrinkles and fine lines include botulinum toxin (marketed under the trademark Botox®) which inhibits neurotransmission in nerve cells, thereby causing contracted muscles to relax. 
         [0008]    In order to increase the speed and effectiveness of delivery of chemical compositions for treatment, it is known to utilize sonic vibrations. For example, Fahim (U.S. Pat. No. 4,372,296) discloses topical treatment of acne with zinc salt and ascorbic acid in a pharmaceutical carrier which is applied with ultra sonic vibrations. 
         [0009]    Stephen et al. (U.S. Pat. No. 4,979,938) disclose a method of treating acne using an applicator electrode having a solution capable of producing hydroxyl ions. An applicator electrode is placed against the skin and a voltage differential is applied to produce and drive hydroxyl ions into the skin tissue. 
         [0010]    Sun et al. (U.S. Pat. No. 7,479,133) discloses a device for treating acne or rosacea by applying an electrical charge with two conductive electrodes in communication with a carrier containing an electrolyte. 
         [0011]    More recently, the Durand patent publications (U.S. Patent Publication No. 2009/0048556 and 2009/0149800) disclose a drug delivery system including a pair of electrodes coupled to drug reservoirs  24  controlled by a microprocessor  12 . The microprocessor may be programmed through a wireless signal receiver. 
         [0012]    Notwithstanding the forgoing, there remains a need for an effective, simple, non-invasive and non-surgical process and system utilizing a disposable patch for treating wrinkles and fine lines. 
         [0013]    There also remains a need for a process and system utilizing a disposable patch for wrinkle reduction which may be manufactured at low-cost and high volume. 
         [0014]    There also remains a need for a process and system utilizing a disposable patch for wrinkle reduction with precision timing of delivery of active ingredients. 
         [0015]    There also remains a need for an apparatus having an adhesive disposable patch with a plurality of active ingredients, a power supply, and a controller in communication with the power supply controlling current using a ramping current profile. 
       SUMMARY OF INVENTION 
       [0016]    The present invention is directed to a process or method of use and a system for wrinkle reduction. 
         [0017]    The system includes a patch assembly applied and adhesively secured to the skin of the consumer. Each patch assembly includes a substantially planar top sheet and a substantially planar substrate. Connectors or snaps pass through the top sheet and substrate. On the substrate is a layer of a chemical composition including active ingredients and an adhesive in order to adhere to the skin. 
         [0018]    The patch assembly or assemblies are connectable to a detachable electronic locket assembly. The locket assembly may include a housing to form an enclosure. Within the enclosure of the housing is a battery which powers a microprocessor based controller or printed circuit board (PCB). The controller is wired to a pair of electrodes through wires to a wiring harness. The housing, the battery and the controller are suspended from the wiring harness. 
         [0019]    In order to use the present invention, the patch assembly or assemblies are positioned and aligned on the skin so that the chemical composition is in contact with and applied to the skin. A pair of electrodes arc connected to the connectors or snaps of the patch assembly. 
         [0020]    A current is applied from the locket assembly through the electrodes into the chemical composition of the patch assembly for a selected time period. The active ingredients of the chemical composition are propelled into the skin of the consumer in order to relax the skin. Alter a selected period of time, the current is stopped and the patch assembly is removed. 
         [0021]    The patch assembly may then be disconnected from the locket assembly. The patch assembly may thereafter be discarded and the locket assembly may be reused. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0022]      FIG. 1  is an illustration of a first preferred embodiment of a process and system for iontophoretic wrinkle reduction in accordance with the present invention; 
           [0023]      FIG. 2A  illustrates a prospective view and  FIG. 2B  is an exploded view of patch assemblies of the first preferred embodiment of the present invention; 
           [0024]      FIG. 3A  is a patch assembly of a second preferred embodiment while  FIG. 3B  is an exploded view of the patch assembly shown in  FIG. 3A ; 
           [0025]      FIG. 4  illustrates an exploded view of an electronic locket assembly utilized in connection with the present invention; 
           [0026]      FIGS. 5A ,  5 B and  5 C show alternate views of the lock assembly shown in  FIG. 4 ; 
           [0027]      FIG. 5D  is a sectional view taken through section line D-D of  FIG. 5A ; 
           [0028]      FIG. 6  is a diagrammatic flow chart of the process or method of application of the present invention; and 
           [0029]      FIG. 7  illustrates a schematic representation of delivery of the electric current cycle during usage of the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
       [0030]    The embodiments discussed herein are merely illustrative of specific manners in which to make and use the invention and are not to be interpreted as limiting the scope of the present invention. 
         [0031]    While the invention has been described with a certain degree of particularity, it is to be noted that many modifications may be made in the details of the invention&#39;s construction and the arrangement of its components without departing from the spirit and scope of this disclosure. It is understood that the invention is not limited to the embodiments set forth herein for purposes or exemplification. 
         [0032]    The present invention includes at least two preferred embodiments—a first preferred embodiment utilized on the skin surrounding the eyes of a consumer and a second preferred embodiment utilized on the forehead and bridge of the nose of a consumer. 
         [0033]    Referring to the drawings in detail,  FIG. 1  is an illustration of the first preferred embodiment  10  of the present invention surrounding the eyes of a consumer. As will be described herein in detail, a pair of patch assemblies  12  and  14  are applied and adhesively secured to the skin of a consumer surrounding the eyes. 
         [0034]      FIG. 2A  illustrates a perspective view of the patch assemblies  12  and  14  prior to use and  FIG. 2B  is an exploded view of the patch assemblies  12  and  14  illustrating the components thereof 
         [0035]    Each of the patch assemblies  12  and  14  may include a substantially planar top sheet  16  and  18 , respectively. The patch assemblies  12  and  14  may also include a substantially planar substrate  20  and  22 , respectively. 
         [0036]    The top sheet  16  and  18  and the substrates  20  and  22  each have holes or apertures which are aligned in order to receive conductive connectors or snaps  24  and  26  that pass therethrough. Each of the connectors or snaps may be in two-part form. In one non-limiting example, known type electro-mechanical connectors may be utilized. 
         [0037]    Adjacent and on the substrates  20  and  22  are layers of a chemical composition, which may be in the nature of a hydrogel  28  and  30 , respectively. The hydrogel  28  and  30  will contain active ingredients of the chemical composition and may also include an adhesive in order to adhere to the skin. The active ingredients may include hyaluronic acid, stressed yeast cell lysate, yeast cell derivative, and cross-linked synthetically derived protein. The hyaluronic acid may be in the range of 0.1 to 15%. 
         [0038]    The hydrogel  28  and  30  are in fluid communication with the connections or snaps  24  and  26 . Accordingly, current or voltage delivered to the connectors or snaps is delivered to the hydrogel. Alternatively or additionally, carbon ink may be added to the substrate layers to improve the conductivity of the electrode assembly. 
         [0039]    The patch assemblies  12  and  14  may be stored and transported on a release liner sheet  32 . The patch assemblies may be easily peeled off or removed from the liner sheet. The entire assemblies and the liner sheet  32  may be stored in a pouch  34 . 
         [0040]    A second preferred embodiment of the present invention to be applied to the forehead and bridge of the nose is shown in assembled form in  FIG. 3A  and is shown exploded in  FIG. 3B . 
         [0041]    The second preferred embodiment includes a patch assembly  42  shown fully assembled in  FIG. 3A  prior to use. The patch assembly  42  may include a substantially planar top sheet  44  and an aligned substantially planar substrate  46 . The top sheet  44  and substrate  46  each include aligned holes or apertures to receive a pair of connectors or snaps  48  and  50 . 
         [0042]    The patch assembly includes a layer of chemical composition in the hydrogel  52 . The entire patch assembly  42  may be transported and stored on a liner sheet  54 . The patch assembly  42  and the liner sheet may be stored in a pouch  56 . 
         [0043]    In a preferred arrangement, the patch assemblies are disposable after use. In each embodiment, the patch assemblies are connectable to an electronic locket assembly  60 . 
         [0044]      FIG. 4  illustrates an exploded view of the electronic locket assembly  60 .  FIGS. 5A ,  5 B and  5 C show alternate views of the locket assembly  60  with  FIG. 5D  illustrating a sectional view taken through section line D-D of  FIG. 5A . The locket assembly  60  may include a front housing  62  which mates with a rear housing  64  to form an enclosure. Attached to the housing may be an optional clasp or clip  66 . Within the enclosure of the housing is a battery  68  which powers a microprocessor based controller or printed circuit board (PCB)  70 . A contact or contacts  72  connect the battery  68  to the controller  70 . 
         [0045]    The microprocessor based controller  70  is, in turn, wired to a pair of electrodes  74  and  76  through wires or a wiring harness  78 . 
         [0046]    The housing  62  and  64 , the battery  68  and controller  70  may hang from or be suspended from the wiring harness  78 . 
         [0047]    The process and system of the present invention uses iontophoresis as the motive force for transdermal delivery of a defined amount of active ingredients. 
         [0048]    In order to use the system of the present invention, initially, the patch assembly or assemblies are removed from the storage pouch and removed from the liner sheet and then positioned and aligned on the skin so that the chemical composition is in contact with and applied to the skin. The adhesive in the chemical composition serves to removably secure the patch assembly to the skin. 
         [0049]    The pair of electrodes  74  and  76  are connected to the connectors or snaps of the patch assembly either in advance of application to the skin or after application. The process is continued by electronically activating the patch assembly. 
         [0050]    Thereafter, a current is applied from the locket assembly  60  through the electrodes  74  and  76  into the chemical composition of the patch assembly for a selected time period. The active ingredients of the chemical composition are propelled into the skin of the consumer in order to relax the skin or achieve other beneficial results. After a selected period of time, the current is stopped and the patch assembly is removed from the skin. The patch assembly may be disconnected from the locket assembly  60 . The patch assembly may thereafter be discarded. 
         [0051]    As an additional step or measure, after the patch assembly is removed, any residue of the chemical composition may be massaged into the skin. The procedure may be periodically repeated. 
         [0052]      FIG. 6  illustrates a diagrammatic, flow chart of the process or method of application of the current during the delivery cycle of the invention. After start of the procedure, as shown in Box  82 , the microprocessor based controller  70  will conduct a self initialization test as shown in Box  84 . The process can be started conventionally by a button or switch or may be activated by a change in resistance between the electrodes triggered by skin contact. 
         [0053]    If the initialization test does not result in an affirmative outcome, a solid red LED or other indicator will be provided as shown at Box  86  and the device will not be used. If the initialization test is satisfactory, as shown in Diamond  88 , proper functioning will be indicated by a green LED as shown at Box  90 . 
         [0054]    Current to the device will be permitted to ramp up and a timer will be started as shown at Box  92 . While the current is being delivered through the chemical composition and into the skin, a blinking green LED will be employed, as shown at Box  94 . 
         [0055]    The polarity of the current will be cycled or alternated as shown at Box  96 .  FIG. 7  illustrates a schematic representation of the current cycle. The current will be ramped up and then held for a time period. Thereafter, the current will be ramped down and the polarity changed. 
         [0056]    Additionally, a mid-cycle self diagnostic test may be performed by the controller as shown at box  98 . If an error is detected, a red LED will be displayed as shown at Box  100  and the procedure will be terminated. If the diagnostic test is satisfactory, as shown at Diamond  102 , the procedure will be continued until the time period is completed as shown at Diamond  104 . When the time period has been completed, the green light ceases to blink and remains on for a period of time to indicate the end of the procedure as shown at Box  106 . 
         [0057]    Thereafter, the patch assembly is removed from the skin and the locket assembly  60  is detached from the patch assembly. The locket assembly may be reused. 
         [0058]    If at any time after the cycle has started, one of the electrodes or patch assemblies falls off, an error condition is signaled. If not reconnected within a reasonable time, the system defaults to an off position. 
         [0059]    Whereas, the present invention has been described in relation to the drawings attached hereto, it should be understood that other and further modifications, apart from those shown or suggested herein, may be made within the spirit and scope of this invention.