Methods and Compositions for Tissue Augmentation

Abstract

Methods and compositions for use in tissue volume replacement are provided. The present invention comprises compositions comprising a combination of materials, comprising preferably a solid polymer particle phase and a gel phase, and also comprises single phase compositions. More particularly, preferred embodiments comprise a solid polymer particle phase made of materials comprising Gore-Tex (micronized e-PTFE), PDS II (polydioxanone, a monofilament), NUROLON (a long chain aliphatic polymer Nylon 6 or Nylon 6,6) ETHILON (a long chain aliphatic polymer Nylon 6 and Nylon 6,6), PROLENE (Polypropylene, isotactic crystalline stereoisomer of polypropylene, a synthetic linear polyolefin.), VICRYL (copolymer made from 90% glycolide and 10% L-lactide), silk, MONACRYL (poly ε-caprolactone.), polylactide, polyglycolide, poly lactide-co-glycolide, and BIOPOL (polyhydroxyvalerate), MEDPOR (biocompatible (micronized) polyethylene), BIOGLASS (bioactive glass particulate), NOVABONE and NOVABONE-CM, and the gel phase comprises polyvinylpyrrolidone (PVP). Preferred single phase compositions comprise PVP. Methods of the present invention comprising injection of such compositions for tissue augmentation.

1 . A biphasic injectable composition for tissue volume replacement 
 a solid polymer phase; and    a carrier substrate phase.    
     
     
         2 . The composition of  claim 1 , wherein the solid polymer phase is made from micronized expanded polytetrafluoroethylene (“e-PTFE”) particles, polydioxanone, long chain aliphatic polymers Nylon 6, long chain aliphatic polymers Nylon 6,6, polypropylene, copolymer made from 90% glycolide and 10% L-lactide, silk, poly ε-caprolactone, polylactide, polyglycolide, poly lactide-co-glycolide, polyhydroxyvalerate, biocompatible micronized polyethylene, bioactive glass particulate, synthetic bone graft particulate, or polyhydroxyvalerate.  
     
     
         3 . The composition of  claim 1 , wherein the solid polymer phase is made from at least two of micronized expanded polytetrafluoroethylene (“e-PTFE”) particles, polydioxanone, long chain aliphatic polymers Nylon 6, long chain aliphatic polymers Nylon 6,6, polypropylene, copolymer made from 90% glycolide and 10% L-lactide, silk, poly ε-caprolactone, polylactide, polyglycolide, poly lactide-co-glycolide, polyhydroxyvalerate, biocompatible micronized polyethylene, bioactive glass particulate, synthetic bone graft particulate, or polyhydroxyvalerate.  
     
     
         4 . The composition of  claim 1 , wherein the carrier substrate phase is selected from polyvinylpyrrolidone (“PVP”), silicone oil, gelatin, collagen, fat, hyaluronic acid, saline, water or plasma.  
     
     
         5 . The composition of  claim 1  wherein the solid polymer phase comprises micronized expanded polytetrafluoroethylene (“e-PTFE”) particles.  
     
     
         6 . The composition of  claim 5 , wherein the e-PTFE particles range in size from approximately 65 to 1000 micrometers.  
     
     
         7 . The composition of  claim 1 , wherein the carrier substrate phase is PVP.  
     
     
         8 . The composition of  claim 7 , wherein the PVP comprises a K value from approximately less than 12 to 100.  
     
     
         9 . The composition of  claim 7 , wherein the PVP comprises a K value from approximately less than 12 to 50.  
     
     
         10 . The composition of  claim 7 , wherein the PVP comprises a K value from approximately less than 12 to 20.  
     
     
         11 . The composition of  claim 7 , wherein the PVP comprises a K value of 17.  
     
     
         12 . The composition of  claim 1 , wherein the solid polymer phase comprises e-PTFE; and 
 the carrier substrate phase comprises PVP.    
     
     
         13 . The composition of  claim 12  wherein the e-PTFE and the PVP are combined at a ratio of approximately 3:2 PVP to e-PTFE by weight.  
     
     
         14 . The composition of  claim 1 , wherein the carrier substrate phase comprises micronized polydioxanone particles ranging in size from approximately 65 to 1000 micrometers  
     
     
         15 . A method for tissue augmentation comprising: 
 injecting a biphasic injectable composition comprising: 
 a solid polymer phase; and  
 a carrier substrate phase.  
   
     
     
         16 . The method of  claim 15 , wherein the solid polymer phase is made from micronized expanded polytetrafluoroethylene (“e-PTFE”) particles, polydioxanone, long chain aliphatic polymers Nylon 6, long chain aliphatic polymers Nylon 6,6, polypropylene, copolymer made from 90% glycolide and 10% L-lactide, silk, poly s-caprolactone, polylactide, polyglycolide, poly lactide-co-glycolide, polyhydroxyvalerate, biocompatible micronized polyethylene, bioactive glass particulate, synthetic bone graft particulate, or polyhydroxyvalerate.  
     
     
         17 . The method of  claim 15 , wherein the carrier substrate phase is selected from polyvinylpyrrolidone (“PVP”), silicone oil, gelatin, bovine collagen, autologous fat, hyaluronic acid, saline, water or autologous plasma.  
     
     
         18 . The method of  claim 15 , wherein injecting comprises: 
 inserting a delivery apparatus containing the biphasic injectable composition into the injection site.    
     
     
         19 . The method of  claim 15 , wherein the injecting comprises subcutaneous, intradermal, intramuscular, periurethral injection or injecting the vocal cords.