Tissue bulking and coating compositions

Abstract

Compositions comprising macromers having a backbone comprising units having a 1,2-diol and/or 1,3-diol structure for tissue bulking and coating. Such polymers include poly(vinyl alcohol) (PVA) and hydrolyzed copolymers of vinyl acetate, for example, copolymers with vinyl chloride, N-vinylpyrrolidone, etc. The backbone polymer contains pendant chains bearing crosslinkable groups and, optionally, other modifiers. When crosslinked, the macromers form hydrogels having many properties advantageous for use as agents to hulk and coat tissues.

1 . A tissue bulking or coating composition comprising macromers having a polymeric backbone comprising units having a 1,2-diol or 1,3-diol structure and at least two pendant chains bearing crosslinkable groups, wherein the composition can be delivered to the intended site of bulking or coating and the macromers crosslinked in situ to form a hydrogel, without the application of heat or light.  
     
     
         2 . (canceled)  
     
     
         3 . The composition of  claim 2 , wherein the pendant chains bearing crosslinkable groups are attached to the backbone via the 1,2-diol or 1,3-diol groups.  
     
     
         4 . The composition of  claim 3 , wherein the pendant chains bearing crosslinkable groups are attached to the backbone via cyclic acetal linkages.  
     
     
         5 . The composition of  claim 1 , wherein the polymer comprises poly(vinyl alcohol) (PVA) and copolymers thereof.  
     
     
         6 . The composition of  claim 1 , wherein the macromers comprise units having the formula:  
       
         
           
           
               
               
           
         
       
       in which R is a linear or branched C 1 -C 8  alkylene; R 1  is hydrogen, a C 1 -C 6  alkyl, or a cycloalkyl; R 2  is hydrogen or a C 1 -C 6  alkyl; and R 3  is an olefinically unsaturated electron attracting copolymerizable radical having up to 25 carbon atoms.  
     
     
         7 . The composition of  claim 1 , wherein the macromers further comprise pendant modifier groups.  
     
     
         8 . The composition of  claim 1 , further comprising an active agent.  
     
     
         9 . The composition of  claim 1 , wherein the macromers form a hydrogel that is biodegradable.  
     
     
         10 . The composition of  claim 1 , further comprising a contrast agent.  
     
     
         11 . The composition of  claim 1 , further comprising a copolymerizable monomer.  
     
     
         12 . The composition of  claim 1 , wherein the crosslinkable groups are olefinically unsaturated groups and are crosslinkable via free radical polymerization.  
     
     
         13 . (canceled)  
     
     
         14 . The composition of  claim 12 , wherein the free radical polymerization is redox initiated.  
     
     
         15 - 67 . (canceled)  
     
     
         68 . A method for tissue bulking or coating comprising administering the composition of  claim 1 .  
     
     
         69 . (canceled)  
     
     
         70 . A composition for forming a tissue bulking or coating article in situ comprising at least two parts, wherein a first part is a solution of macromers having a polymeric backbone including units with a 1,2-diol or 1,3-diol structure and at least two pendant chains bearing crosslinkable groups, and a second part includes a crosslinking initiator, and wherein the composition forms a hydrogel when the parts are combined inside the body.  
     
     
         71 . The composition of  claim 70 , wherein the crosslinking initiator is selected from the group consisting of a second macromer that crosslinks with the macromer in the first part, and a redox initiator.  
     
     
         72 . The composition of  claim 70 , wherein the first part includes one component of a redox couple and the crosslinking initiator in the second part is the other component of the redox couple.  
     
     
         73 . The composition of  claim 70 , wherein the second part is also a solution and the two parts are delivered to the intended site of embolization using a multi lumen catheter.  
     
     
         74 . The embolic composition of  claim 70 , wherein the macromers comprise units having the formula:  
       
         
           
           
               
               
           
         
       
       in which R is a linear or branched C 1 -C 8  alkylene; R 1  is hydrogen, a C 1 -C 6  alkyl, or a cycloalkyl; R 2  is hydrogen or a C 1 -C 6  alkyl; and R 3  is an olefinically unsaturated electron attracting copolymerizable radical having up to 25 carbon atoms.