Microprotrusion Arrays and Methods for Using Same to Deliver Substances into Tissue

Abstract

Improved microprotrusion abrasion devices having fluid retaining or directing patterns, and specific design parameters and method for delivery of substances into the skin. Various configurations of such devices are disclosed, including domed, channeled, patterned and stepped.

1 . A microprotrusion array for the delivery of a fluid substance into tissue, said array comprising: 
 at least one platen having a platen edge, said platen comprising a lenticular microprotrusion surface, wherein said lenticular microprotrusion surface is formed from a planar microprotrusion surface which has been deformed;    a plurality of microprotrusions on said microprotrusion surface of said platen, wherein each microprotrusion has an initial shape prior to deformation of the planar microprotrusion surface, wherein each microprotrusion has substantially retained its initial shape after the deformation of the planar microprotrusion surface into the lenticular microprotrusion surface; and    at least one fluid substance retaining portion, said substance retaining portion selected from the group consisting of intra-microprotrusion spacing, one or more recesses between said microprotrusions, one or more areas devoid of microprotrusions, one or more areas of reduced microprotrusion density, one or more areas of microprotrusions attached to the platen in a pattern adapted to direct said substance toward the interior of said array, one or more channels in the platen microprotrusion attachment surface, and combinations thereof.    
   
   
       2 . The array of  claim 1 , wherein the pattern of attached microprotrusions adapted to direct said substance comprises areas of differing microprotrusion densities.  
   
   
       3 . The array of  claim 1 , wherein said platen edge has a thickness.  
   
   
       4 . The array of  claim 1 , wherein said platen edge is smooth.  
   
   
       5 . The array of  claim 1 , wherein said platen edge is beveled.  
   
   
       6 . The array of  claim 1 , wherein said platen edge is radiused.  
   
   
       7 . The array of  claim 1 , wherein said microprotrusion surface of said platen is comprised of a plastic material.  
   
   
       8 . The array of  claim 1 , wherein said microprotrusion surface comprises a plurality of channels disposed between said microprotrusion bases.  
   
   
       9 . The array of  claim 8 , wherein said channels are disposed in one direction.  
   
   
       10 . The array of  claim 8 , wherein said channels are disposed in more than one direction.  
   
   
       11 . The array of  claim 1 , wherein said microprotrusion lengths are in a range from 5 to 500 microns.  
   
   
       12 . The array of  claim 1 , wherein said microprotrusion lengths are in a range from 50 to 300 microns.  
   
   
       13 . The array of  claim 1 , wherein said microprotrusion lengths are in a range from 140 to 250 microns.  
   
   
       14 . The array of  claim 1 , wherein said microprotrusion lengths are in a range from 160 to 220 microns.  
   
   
       15 . The array of  claim 1  wherein the lenticular microprotrusion surface is substantially a converging meniscus.  
   
   
       16 . The array of  claim 1  wherein the lenticular microprotrusion surface is substantially a diverging meniscus.  
   
   
       17 . The array of  claim 1  wherein the lenticular microprotrusion surface is substantially a cylindrical bend.  
   
   
       18 . A method for forming a lenticular micro protrusion array comprising: 
 providing a substantially planar microprotrusion array comprising a plurality of microprotrusions attached to a planar substrate;    providing a fixture having a top block and a bottom block wherein the fixture is adapted to hold the planar microprotrusion array, and the top block further comprises a lenticular forming mandrel adapted to deform the planar microprotrusion array;    removably affixing the planar microprotrusion array into the bottom block with the plurality of microprotrusions facing away from the top block;    heating the microprotrusion array to a temperature such that microprotrusion array may be plastically deformed;    lowering the forming mandrel onto the microprotrusion array;    cooling the microprotrusion array to such a temperature that the geometry of the forming mandrel is substantially maintained.    
   
   
       19 . The method of  claim 18  further comprising deforming the planar array approximately 0.040″ to 0.10 inches in total height from the center of microprotrusion array to an edge of microprotrusion array.  
   
   
       20 . The method of  claim 18 , wherein the plurality of microprotrusions are substantially unchanged in shape.