Method and apparatus for manufacturing a device

Abstract

A device, preferably a micro-device, is molded from a plastic material by injection molding, compression molding or embossing. A microabrader can be molded having microneedles for abrading the stratum corneum of the skin to form an abraded site in the tissue for enhancing drug delivery. The micro-device is molded using a mold assembly having a silicon molding surface. The silicon molding surface can include a recess corresponding to the desired shape and length of the microneedles. The silicon molding surface enables micron and submicron size features to be molded from polymeric materials without the polymeric material adhering to the mold surface. Micro-devices having molded features having micron and submicron dimensions can be rapidly produced without the use of a release agent.

What is claimed is:  
     
         1 . A method of making a molded device comprising the steps of: 
 providing a mold assembly having a mold section with a recess defining a mold cavity and having a silicon mold member disposed in said mold cavity, said silicon mold member having a mold surface with a contoured surface defining an impression of said device facing said mold cavity;    introducing a plastic material into said mold cavity to fill said mold cavity and said contoured surface in said silicon mold member to form said molded device having a body and molded surface corresponding to said contoured surface; and    removing said molded device from said mold section.    
     
     
         2 . The method of  claim 1 , wherein said molded device is a microneedle device having a plurality of microneedles, about 5 to 250 microns in length.  
     
     
         3 . The method of  claim 2 , wherein said microneedles are hollow.  
     
     
         4 . The method of  claim 1 , wherein said silicon mold member releases of said device from the mold surface and said molding is in the absence of a release agent, whereby said molded device is substantially clean and sterile.  
     
     
         5 . The method of  claim 1 , wherein said mold cavity has a plurality of side walls and a bottom surface, and said silicon mold member is bonded to said bottom surface.  
     
     
         6 . The method of  claim 5 , wherein said silicon mold member has an outer peripheral edge corresponding to the shape of said mold cavity, wherein said silicon mold member substantially covers said bottom surface of said mold cavity.  
     
     
         7 . The method of  claim 6 , wherein said mold surface of said silicon mold member is substantially flat.  
     
     
         8 . The method of  claim 7 , wherein said recesses in said mold surface are spaced apart uniformly to form rows and columns, each of said recesses having a depth of about 5 to about 250 microns and said recesses being spaced to provide a density of about 4 to about 100 of said recesses per mm 2 .  
     
     
         9 . The method of  claim 1 , wherein said polymeric material is selected from the group consisting of polycarbonates, polyethylenes, polypropylene, polystyrene, polyesters and polyamides.  
     
     
         10 . The method of  claim 1 , wherein said contoured surface of said silicon mold member has at least one recess, peak or ridge with at least one dimension ranging from about 0.5 micron to about 500 microns.  
     
     
         11 . The method of  claim 1 , wherein said mold assembly includes an inlet in communication with said mold cavity, and said introducing step comprises injecting said plastic material through said inlet to said mold cavity.  
     
     
         12 . The method of  claim 1 , wherein said introducing step comprises injecting a hot thermoplastic material into said mold cavity.  
     
     
         13 . The method of  claim 1 , wherein said introducing step comprises introducing a thermoplastic material into said cavity and heating and compressing said thermoplastic material to mold said device.  
     
     
         14 . The method of  claim 1 , wherein said introducing step comprises positioning a thermoplastic substrate on said mold cavity and pressing said mold assembly against said substrate to form said molded device.  
     
     
         15 . A device made by the method of  claim 1 .  
     
     
         16 . A method of injection molding a device, said method comprising the steps of: 
 providing a mold assembly having a mold section with a recess defining a mold cavity, said recess having at least one side wall and a bottom wall, and a silicon mold member coupled to said mold section within said recess, said silicon mold member having a contoured mold surface facing said mold cavity and having at least one recess of about 5 to about 250 microns in at least one dimension;    closing said mold cavity and injecting a hot polymeric material into said mold cavity to substantially fill said mold cavity and to form a molded device, without said polymeric material adhering to said silicon mold member; and    cooling the mold assembly and removing said molded device from said mold cavity, said molded device having a surface corresponding to said mold surface.    
     
     
         17 . The method of  claim 16 , wherein said molded device is molded substantially in the absence of a release agent on said silicon mold member or said mold surface.  
     
     
         18 . The method of  claim 16 , wherein said silicon mold member has an outer peripheral edge corresponding to the shape of said mold cavity, wherein said silicon mold member substantially covers said bottom wall of said mold cavity.  
     
     
         19 . The method of  claim 16 , wherein said mold surface includes a plurality of spaced apart recess to form rows and columns, and said recesses being spaced to provide a density of about 4 to about 100 of said recesses per mm 2 .  
     
     
         20 . The method of  claim 16 , wherein said polymeric material is selected from the group consisting of polycarbonates, polyethylenes, polypropylene, polystyrene, polyesters and polyamides.  
     
     
         21 . The method of  claim 16 , wherein said molded device is a microneedle device.  
     
     
         22 . The method of  claim 16 , wherein said contoured surface of said silicon mold member has at least one recess, peak or ridge with at least one dimension ranging from about 0.5 micron to about 500 microns.  
     
     
         23 . A mold assembly comprising: 
 a mold section with a recess defining a mold cavity for receiving a molding material and forming a molded device; and    a silicon mold member disposed in said mold cavity, said silicon mold member with a mold surface facing said mold cavity, said mold surface having a contoured surface defining an impression for molding said device.    
     
     
         24 . The assembly of  claim 23 , wherein said mold member includes a plurality of recesses, about 5 to 250 microns deep.  
     
     
         25 . The assembly of  claim 23 , wherein said mold cavity has a plurality of side walls and a bottom surface, and said silicon mold member is bonded to said bottom surface.  
     
     
         26 . The assembly of  claim 25 , wherein said silicon mold member has an outer peripheral edge corresponding to the shape of said mold cavity, wherein said silicon mold member substantially covers said bottom surface of said mold cavity.  
     
     
         27 . The assembly of  claim 26 , wherein said mold surface of said silicon mold member is substantially flat.  
     
     
         28 . The assembly of  claim 23 , wherein said recesses in said mold surface are spaced apart uniformly to form rows and columns, each of said recesses having a depth of about 5 to about 250 microns and said recesses being spaced to provide a density of about 4 to about 100 of said recesses per mm 2 .