Delivery devices and methods for making the same

Abstract

In an example of a method for making a pulsatile delivery device, one type of charges are generated on a polymeric layer, and charges opposite the one type of charges are generated on a delivery layer including a film forming material and a predetermined substance dispersed throughout the film forming material. The charged polymeric and delivery layers are placed into contact to form a bi-layer structure. A stack with at least two bi-layer structures is formed so that the polymeric layers and the delivery layers are alternating throughout the stack. The stack is sealed so that one of the polymeric layers remains exposed.

1 .- 11 . (canceled) 
     
     
         12 . A continuous delivery device, comprising:
 a disk including a plurality of substance-encapsulated polymeric microspheres compressed together.   
     
     
         13 . The continuous delivery device as defined in  claim 12 , further comprising an elastic sealant partially surrounding the disk so that at least one surface of the disk is exposed. 
     
     
         14 . The continuous delivery device as defined in  claim 12  wherein:
 a substance encapsulated in the substance-encapsulated polymeric microspheres is selected from the group consisting of a drug, a vaccine, a protein, a peptide, a growth factor, a hormone, a deoxyribonucleic acid, a ribonucleic acid, and combinations thereof; and 
 a polymer of the substance-encapsulated polymeric microspheres is selected from the group consisting of polyanhydrides, poly(ortho esters), poly(lactide-co-glycolide), polyglycolic acid, poly(L-lactic acid), polycaprolactone, poly(hydroxy butyrate), poly(phosphoesters), poly(propylene fumarate), polyphosphazenes, polycarbonates, polyurethane, copolymers thereof, and combinations thereof. 
 
     
     
         15 . The continuous delivery device as defined in  claim 14  wherein the substance is contained in hydrophilic domains distributed throughout the polymer, and wherein the hydrophilic domain is selected from the group consisting of alginate, polyethylene glycol, collagen, gelatin, hyaluronic acid, starch, glycogen, cellulose, caragena, dextran, chitin, chitosan, pectin, heparin, heparan sulfate, copolymers thereof, a sugar, a salt, and combinations thereof. 
     
     
         16 . A method for making a continuous delivery device, the method comprising:
 forming substance-encapsulated polymeric microspheres using a double emulsion technique; and   compressing the substance-encapsulated polymeric microspheres into a disk.   
     
     
         17 . The method as defined in  claim 16 , further comprising sealing the disk so that one surface of the disk remains exposed. 
     
     
         18 . The method as defined in  claim 17  wherein sealing the disk includes casting a solution of an elastic sealant material on the outer edge of the disk to form a construct, and wherein the method further comprises:
 subjecting the construct to vacuum; 
 repeating the casting and subjecting; and 
 drying the construct. 
 
     
     
         19 . The continuous delivery device as defined in  claim 12  wherein the substance-encapsulated polymeric microspheres have dimensions ranging from about 1 nm to about 1000 nm. 
     
     
         20 . The continuous delivery device as defined in  claim 12  wherein the elastic sealant is selected from the group consisting of polycaprolactone (PCL), a PCL copolymer, poly(glycerol sebacate)), polyurethane, poly(diol citrate), elastin, and an elastin-like polypeptide. 
     
     
         21 . The method as defined in  claim 16  wherein the double emulsion technique involves:
 dissolving a substance in water to form a water phase; 
 mixing a biodegradable material and a solvent to form an oil phase; 
 emulsifying the oil phase in the water phase to form a first emulsion; 
 adding the first emulsion to a second water phase under sonication to form a second emulsion; 
 allowing liquid of the second emulsion to evaporate. 
 
     
     
         22 . The method as defined in  claim 16  wherein the water phase further includes a denaturing agent selected from the group consisting of alginate, poly(ethylene glycol), collagen, gelatin, hyaluronic acid, starch, glycogen, cellulose, caragena, dextran, chitin, chitosan, pectin, heparin, heparan sulfate, copolymers thereof, and combinations thereof.