Fragmented polymeric compositions and methods for their use

Abstract

Cross-linked hydrogels comprise a variety of biologic and non-biologic polymers, such as proteins, polysaccharides, and synthetic polymers. Such hydrogels preferably have no free aqueous phase and may be applied to target sites in a patient's body by extruding the hydrogel through an orifice at the target site. Alternatively, the hydrogels may be mechanically disrupted and used in implantable articles, such as breast implants. When used in vivo, the compositions are useful for controlled release drug delivery, for inhibiting post-surgical spinal and other tissue adhesions, for filling tissue divots, tissue tracts, body cavities, surgical defects, and the like.

What is claimed is:  
     
         1 . A fragmented biocompatible hydrogel which is substantially free from an aqueous phase.  
     
     
         2 . The hydrogel of  claim 1 , having a subunit size when fully hydrated in the range from 0.01 mm to 5 mm.  
     
     
         3 . The hydrogel of  claim 1 , having an equilibrium swell from 400% to 5000%.  
     
     
         4 . The hydrogel of  claim 1 , having an in vivo degradation time of less than one year.  
     
     
         5 . The hydrogel of  claim 1 , having at least one characteristic selected from the group consisting of (a) a subunit size when fully hydrated in the range from 0.01 mm to 5 mm, (b) an equilibrium swell from 400% to 5000%, and (c) an in vivo degradation time of less than one year.  
     
     
         6 . The hydrogel of  claim 5 , having at least two of the three characteristics.  
     
     
         7 . The hydrogel of  claim 5 , having all three characteristics.  
     
     
         8 . The hydrogel of any of  claims 1  to  7 , said hydrogel being at least partially hydrated with an aqueous medium comprising an active agent.  
     
     
         9 . The hydrogel of  claim 8 , wherein the active agent is a clotting agent.  
     
     
         10 . The hydrogel of  claim 9 , wherein the clotting agent is thrombin.  
     
     
         11 . A method for delivering an active agent to a patient, said method comprising administering to a target site on the patient an amount of the hydrogel of any of  claims 8  to  10 .  
     
     
         12 . A composition comprising a fragmented biocompatible hydrogel being substantially free of an aqueous phase, wherein the hydrogel is at least partially hydrated with an aqueous solution of thrombin.  
     
     
         13 . A composition as in  claim 12 , wherein the hydrogel comprises a protein.  
     
     
         14 . A composition as in  claim 13 , wherein the protein comprises gelatin.  
     
     
         15 . A composition as in  claim 12 , wherein the hydrogel comprises a polysaccharide.  
     
     
         16 . A composition as in  claim 12 , wherein the hydrogel comprises a non-biological polymer.  
     
     
         17 . A composition as in  claim 12 , wherein the hydrogel comprises two of the following components a) a protein, b) a polysaccharide, and c) a non-biological polymer.  
     
     
         18 . A composition as in  claim 12 , wherein the hydrogel comprises a) a protein, b) a polysaccharide and c) a non-biological polymer.