Abstract:
A needleless microprotrusion method for infusion of a medicament into a patient includes disposing a substrate plurality of microprotrusions onto a patients&#39; palm. A chemodenervating agent is disposed for delivery by the microprotrusions and the substrate supports and conforms the microprotrusions to the patients&#39; palm in order to enable uniform penetration of the microprotrusions into the corneum.

Description:
[0001]     The present application is a division of U.S. Ser. No. 10/915,792 filed Aug. 10, 2004. This application is to be incorporated herewith in toto into the present application. 
     
    
       [0002]     The present invention is generally directed to a delivery system for a medicament and is more particularly directed to a needleless microprotrusion system for infusion of a medicament into a patient.  
         [0003]     Still more particularly, the present invention relates to a novel method of administering chemodenervating agents in a controlled and reproducible manner so as to confine effectiveness of the agent to a given region while minimizing the effects of the agent on adjacent tissue.  
         [0004]     Chemodenervating agents such as, for example, botulinum toxin, has been found effective for the treatment of hyperhidrosis and other dermological indications, such as glabellar lines and brow furrow. Current therapies include topicals, that is, for example, antiperspirants, creams and systemic products. All to often these are short acting and/or ineffective.  
         [0005]     As noted, a significant advantage in ameliorating sweating and removing wrinkle lines has been achieved through the action of botulinum toxin injections. While this specific treatment is revolutionary and efficacious, the patient is unfortunately placed under significant amount of duress and discomfort due to need to administer multiple injections.  
         [0006]     In addition, since each injection represents a possibility for infection, the injections are typically spaced apart from one another, which results in peak and valley concentrations of the medicament.  
         [0007]     The epithelia layer of the skin, also referred to as the epidermis, is a part of the skin which provides a barrier against penetration and consists of four layers. These layers are an outermost layer called the stratum corneum and three underlying layers called the stratum granulosum, the stratum malpighii, and the stratum germinativum.  
         [0008]     The present invention provides for a system for intradermal administration of neurotoxins in the treatment of hyperhidrosis, skin wrinkles including facial lines.  
       SUMMARY OF THE INVENTION  
       [0009]     The present invention provides for a needleless microprotrusion system for infusion of a medicament into a patient which includes a plurality of microprotrusions having a length sufficient to penetrate a stratum corneum of the patient and a chemodenervating agent disposed on or in the microprotrusions.  
         [0010]     A substrate is provided for supporting the microprotrusions with the substrate. The substrate features a shape for conforming to a selected patient body part in order to enable uniform penetration of the microprotrusions into the stratum corneum.  
         [0011]     In one embodiment of the present invention, two pluralities of microprotrusions are provided with one plurality of microprotrusions disposed on one side of the substrate and another plurality of microprotrusions disposed on another side of the substrate.  
         [0012]     A preferred shape for this embodiment includes a substrate sized for positioning within the palm of a patient and preferably the chemodenervating agent in accordance with the present invention comprises botulinum toxin, preferably type A.  
         [0013]     A method in accordance with the present invention utilizing this embodiment basically includes the steps providing a substrate having a shape for conforming to the palm of a patient with the substrate having microintrusions disposed on opposite sides of the substrates. The substrates have a length sufficient to penetrate the stratum corneum of the patients&#39; palm.  
         [0014]     A chemodenervating agent is provided for delivery by the microprotrusions and the patent is instructed to dispose the substrate on one palm and press the other palm against the substrate in order to effect simultaneous delivery of the chemodenervating agent into both palms.  
         [0015]     In another embodiment of the present invention a substrate is size and shaped for conforming to a patients armpit and in yet another embodiment of the present invention the substrate is sized and shaped for application to a glabellar region of the patient.  
         [0016]     In addition, an adhesive disposed on the substrate may be provided for temporarily adhering the substrate to a patients&#39; skin at a selected location and is suitable for receiving the size and shape of the substrate.  
         [0017]     To further enhance uniform penetration of the microprotrusions into the stratum corneum, the substrate is preferably flexible. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0018]     The present invention may be more clearly understood with reference to the following detailed description in conjunction with the appended drawings, of which:  
         [0019]      FIG. 1  is a side view of one embodiment of the present invention generally showing two pluralities of microprotrusions disposed on opposite sides of a substrate;  
         [0020]      FIGS. 2 and 3  illustrate the use of the system shown in  FIG. 1  which includes a substrate sized for positioning within the palm of a user;  
         [0021]      FIGS. 4-5  show other embodiments of the system in accordance with the present invention utilizing a single plurality of microprotrusions and a substrate for supporting the microprotrusions and having a shape for conforming to a selected body part along with an adhesive for temporarily adhering a substrate to a patients&#39; skin;  
         [0022]      FIGS. 6 and 7  illustrate application of the embodiment shown in  FIGS. 4 and 5 ;  
         [0023]      FIG. 8  shows an alternative embodiment of the present invention in which the substrate is sized and shaped for fitting the fossa axillaris (armpit) of a patient;  
         [0024]      FIG. 9  shows and alternative embodiment of the present invention in which the substrate is sized and shaped for positioning against a users&#39; palm and fingers;  
         [0025]      FIG. 10  shows an alternative embodiment of the present invention in whish the substrate is sized and shaped for positioning against a users&#39; sole and toes; and  
         [0026]      FIG. 11  is an enlarge view of the microprotrusions shown in  FIGS. 1 and 4 . 
     
    
     DETAILED DESCRIPTION  
       [0027]     With reference to  FIG. 1 , there is shown a needleless microprotrusion system  10  in accordance with the present invention for infusion of a medicament (not shown) into a patient, also not shown in  FIG. 1 .  
         [0028]     The system  10  generally includes two pluralities  12 ,  14  of microprotrusions  16 ,  18  disposed on opposite sides  20 ,  22  of a substrate  24 .  
         [0029]     The microprotrusions  16 ,  18  may be of any suitable size and configuration and formed from a metal, preferably stainless steel, or other inert material that are directly embedded into the substrate  22  which is preferably an inert platform such as silicone, or polypropylene. With the proper selection of materials, the microprotrusions and substrate may be formed unitarily.  
         [0030]     A chemodenervating agent, preferably botulinum toxin, is disposed on the microprotrusions  16 ,  18  and covered with a removable liner  32  in a conventional manner, said liner being removable for exposing the microprotrusions  16 ,  18  for use.  
         [0031]     As more clearly shown in  FIGS. 2 and 3 , the substrate  22  is sized and shaped for conforming to a patients&#39; palm  36  which enables a method in accordance with the present invention as illustrated in  FIG. 3  in which a patient, following instructions, disposes the system  10  in one palm  36  and press another palm  38  against the system  10  in order to effect simultaneous delivery of the chemodenervating agent into both palms  36 ,  38 .  
         [0032]     This method for delivering the medicament is suitable for treatment of hyperhidrosis. Preferably, the substrate is flexible for enabling uniform penetration of the microprotrusions  16 ,  18  into the patients&#39; palms  36 ,  38  respectively. Microprotrusions suitable for use in the present invention are described in U.S. Pat. No. 6,322,808 which is to be incorporated herewith in its entirety for a description of suitable microprotrusions  16 ,  18  and substrates  24 .  
         [0033]     With reference to  FIGS. 4 and 5 , there are shown alternative embodiments  44 ,  46  in accordance with the present invention which further include exposed portions  48 ,  50  respectively which include an adhesive for temporarily adhering the substrate portions  48 ,  50  to a patient, see  FIGS. 6 and 7  respectively which illustrate application of the embodiment  44  for removing wrinkles adjacent a patients&#39; eye and in a glabellar region of the patient.  
         [0034]     In another embodiment  56  of the present invention as illustrated in  FIG. 8  in which a substrate  58  is sized and shaped for fitting and conforming to a patients armpit  60 .  
         [0035]      FIGS. 9-10  are alternative embodiments  64 ,  66  illustrating substrates  68 ,  70  respectively, which are sized and shaped for positioning against a palm  74  and fingers  76  of a user and for positioning against a sole  80  and toes  80  of a user. Various glove sizes and shoe sizes may be used to produce embodiments  64 ,  66  for use.  
         [0036]      FIG. 11  is an enlarged view of the microprotrusions  16 , which as hereinabove noted, may be coated with botulinum toxin or alternatively, filled with a solution including botulinum toxin.  
         [0037]     In this instance, a reservoir  90  may be provided behind the microprotrusions  16  and covered by a backing  92  for enabling pressure to be exerted on the reservoir for effecting delivery of the botulinum toxin from the microprotrusion.  
         [0038]     It should be appreciated that the length of the microprotrusions are varied depending upon the anatomy of the particular tissue being targeted by the therapeutic neurotoxin.  
         [0039]     Although there has been hereinabove described a specific needleless microprotrusion blastoplast system in accordance with the present invention for the purpose of illustrating the manner in which the invention may be used to advantage, it should be appreciated that the invention is not limited thereto. That is, the present invention may suitably comprise, consist of, or consist essentially of the recited elements. Further, the invention illustratively disclosed herein suitably may be practiced in the absence of any element which is not specifically disclosed herein. Accordingly, any and all modifications, variations or equivalent arrangements which may occur to those skilled in the art, should be considered to be within the scope of the present invention as defined in the appended claims.