Low profile combination device for gastrostomy or jejunostomy applications having anti-granuloma formation characteristics

Abstract

A removable anti-granuloma covering made from an anti-granuloma composition including at least one anti-granuloma agent, wherein the removable anti-granuloma covering is adapted to outfit a medical device for insertion in an artificial opening in a body of a being and wherein the removable covering is adapted to contact an area on a skin surface adjacent to the artificial opening. In certain embodiments, the removable anti-granuloma covering is in a shape of a sleeve, a disk, a sheet, or a layer.

1 . A removable anti-granuloma covering made from an anti-granuloma composition comprising at least one anti-granuloma agent, wherein said removable anti-granuloma covering is adapted to outfit a medical device for insertion in an artificial opening in a body of a being and wherein said removable covering is adapted to contact an area on a skin surface adjacent to the artificial opening.  
   
   
       2 . The removable anti-granuloma covering of  claim 1 , wherein said removable anti-granuloma covering in a shape of a sleeve, a disk, a sheet, or a layer.  
   
   
       3 . The removable anti-granuloma covering of  claim 2 , wherein said removable anti-granuloma covering has an opening shaped to outfit a medical device for insertion in an artificial opening in a body of a being and wherein said removable covering is adapted to contact an area on a skin surface adjacent to the artificial opening.  
   
   
       4 . The removable anti-granuloma covering of  claim 3 , wherein said removable anti-granuloma covering is in a shape of the disk having the opening and wherein said disk comprises said anti-granuloma composition.  
   
   
       5 . The removable anti-granuloma covering of  claim 4 , wherein said at least one anti-granuloma agent is a member selected from the group consisting of an anti-fibrotic agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anti-proliferative agent, cytokine, cytokine inhibitor, growth factor, vascular growth factor, neutralizing antibody, hormone, a cytotoxic agent, an antibiotic, an anti-fungal agent, an anesthetic agent, and a vasoconstrictor.  
   
   
       6 . The removable anti-granuloma covering of  claim 4 , wherein said at least one anti-granuloma agent is a member selected from the group consisting of 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal, 2-(3-benzophenyl)propionic acid, 9-alpha-fluoro-16-alpha-methylprednisolone, methyl prednisone, fluoroxyprednisolone, 17-hydroxycorticosterone, cyclosporin, D-2-(6-methoxy-2-naphthyl)propionic acid, 4-isobutyl-α-methylphenyl acetic acid, Mitomicyin C, transforming growth factor alpha, anti-transforming growth factor beta, epidermal growth factor, vascular endothelial growth factor, anti-transforming growth factor beta antibody, anti-fibroblast antibody, and anti-transforming growth factor beta receptor antibody.  
   
   
       7 . The removable anti-granuloma covering of  claim 4 , wherein said at least one anti-granuloma agent is triamcinolone acetonide or triamcinolone hexacetonide.  
   
   
       8 . The removable anti-granuloma covering of  claim 4 , wherein the anti-granuloma composition further comprises at least one controlled release agent selected from the group consisting of a biodegradable polymer, a nanoparticle, an emulsion, a liposome, and a microsphere.  
   
   
       9 . The removable anti-granuloma covering of  claim 8 , wherein said biodegradable polymer is a member selected from the group consisting of a polysaccharide, poly(lactic acid) and isomers thereof, poly(glycolic acid), poly(lactide-co-glycolide), polyorthoesters, polyanhydrides, polyphosphazene, polycaprolactone, polyhydroxybutyrate, p-dioxanone, poly(dioxanone)(polyether-ester), and blends and copolymers thereof.  
   
   
       10 . The removable anti-granuloma covering of  claim 9 , wherein said biodegradable polymer is poly(lactic acid) and isomers thereof, poly(glycolic acid), or poly(lactide-co-glycolide).  
   
   
       11 . The removable anti-granuloma covering of  claim 4 , wherein said disk is split.  
   
   
       12 . The removable anti-granuloma covering of  claim 11 , wherein said at least one anti-granuloma agent is a member selected from the group consisting of an anti-fibrotic agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anti-proliferative agent, cytokine, cytokine inhibitor, growth factor, vascular growth factor, neutralizing antibody, hormone, a cytotoxic agent, an antibiotic, an anti-fungal agent, an anesthetic agent, and a vasoconstrictor.  
   
   
       13 . The removable anti-granuloma covering of  claim 12 , wherein said at least one anti-granuloma agent is a member selected from the group consisting of 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal, 2-(3-benzophenyl)propionic acid, 9-alpha-fluoro-16-alpha-methylprednisolone, methyl prednisone, fluoroxyprednisolone, 17-hydroxycorticosterone, cyclosporin, D-2-(6-methoxy-2-naphthyl)propionic acid, 4-isobutyl-α-methylphenyl acetic acid, Mitomicyin C, transforming growth factor alpha, anti-transforming growth factor beta, epidermal growth factor, vascular endothelial growth factor, anti-transforming growth factor beta antibody, anti-fibroblast antibody, and anti-transforming growth factor beta receptor antibody.  
   
   
       14 . The removable anti-granuloma covering of  claim 2 , wherein said removable anti-granuloma covering is in a shape of the sleeve, wherein said sleeve is adapted to outfit a medical device for insertion in an artificial opening in a body of a being such that at least a portion of the sleeve is placed to be below a skin surface of the body.  
   
   
       15 . The removable anti-granuloma covering of  claim 14 , wherein said at least one anti-granuloma agent is triamcinolone acetonide or triamcinolone hexacetonide.  
   
   
       16 . The removable anti-granuloma covering of  claim 14 , wherein the anti-granuloma composition further comprises at least one controlled release agent selected from the group consisting of a biodegradable polymer, a nanoparticle, an emulsion, a liposome, and a microsphere.  
   
   
       17 . The removable anti-granuloma covering of  claim 16 , wherein said biodegradable polymer is a member selected from the group consisting of a polysaccharide, poly(lactic acid) and isomers thereof, poly(glycolic acid), poly(lactide-co-glycolide), polyorthoesters, polyanhydrides, polyphosphazene, polycaprolactone, polyhydroxybutyrate, p-dioxanone, poly(dioxanone)(polyether-ester), and blends and copolymers thereof.  
   
   
       18 . The removable anti-granuloma covering of  claim 17 , wherein said biodegradable polymer is poly(lactic acid) and isomers thereof, poly(glycolic acid), or poly(lactide-co-glycolide).  
   
   
       19 . The removable anti-granuloma covering of  claim 14 , wherein said sleeve is split.