US2003211073A1PendingUtilityA1

Tissue bulking and coating compositions

42
Priority: Mar 13, 2000Filed: Jun 19, 2003Published: Nov 13, 2003
Est. expiryMar 13, 2020(expired)· nominal 20-yr term from priority
Inventors:Dennis W. GoupilHassan ChaoukTroy Vernon HollandBruktawit AsfawStephen D. GoodrichLucas Latini
A61B 17/1219A61L 27/16A61B 17/12099A61L 31/048C08F 290/00A61L 24/06A61B 17/12186A61L 27/34A61L 2430/36C08L 51/003C08F 8/30C08F 271/02C08L 51/08A61L 29/085A61L 27/52A61B 17/12122C08F 261/04A61L 24/0031C08F 261/00A61B 17/12022C08F 277/00C08F 290/12A61L 31/10C08F 290/14A61L 29/041
42
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Claims

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 bulk and coat tissue.

Claims

exact text as granted — not AI-modified
What is claimed is:  
     
         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 macromers can be crosslinked to form a hydrogel.  
     
     
         2 . The composition of  claim 1 , wherein the backbone polymer comprises a polyhydroxy polymer.  
     
     
         3 . The composition of  claim 1 , 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 macromer comprises units having the formula:  
       
         
           
           
               
               
           
         
         in which R is a linear or branched C 1 -C 8  alkylene or a linear or branched C 1 -C 12  alkane; 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 macromer further comprises 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 crosslinkable via free radical polymerization.  
     
     
         13 . The composition of  claim 12 , wherein the crosslinkable groups are olefinically unsaturated groups.  
     
     
         14 . The composition of  claim 12 , wherein the free radical polymerization is redox initiated.  
     
     
         15 . The composition of  claim 1 , wherein the macromers are crosslinked into a hydrogel prior to administration to the patient.  
     
     
         16 . The composition of  claim 15 , wherein the hydrogel article is a microsphere.  
     
     
         17 . The composition of  claim 1 , wherein the macromers are polymerized in situ.  
     
     
         18 . A composition comprising macromers that can be crosslinked in situ to form a hydrogel, wherein the macromers having a polymeric backbone comprising units having a 1,2-diol or 1,3-diol structure and at least two pendant chains bearing groups that are crosslinkable via redox initiated free radical polymerization, wherein the composition comprises a first component comprising a reductant and a second component comprising an oxidant wherein the macromers are present in either or both components.  
     
     
         19 . The composition of  claim 18 , wherein the first and second components can be delivered to an intended site of tissue bulking with a microcatheter.  
     
     
         20 . The composition of  claim 18 , wherein the backbone polymer comprises a polyhydroxy polymer.  
     
     
         21 . The composition of  claim 18 . wherein the pendant chains beari .g crosslinkable groups are attached to the backbone via the 1,2-diol or 1,3-diol groups.  
     
     
         22 . The composition of  claim 21 , wherein the pendant chains bearing crosslinkable groups are attached to the backbone via cyclic acetal linkages.  
     
     
         23 . The composition of  claim 18 , wherein the polymer comprises poly(vinyl alcohol) (PVA) and copolymers thereof.  
     
     
         24 . The composition of  claim 18 , wherein the macromer comprises units having the formula:  
       
         
           
           
               
               
           
         
         in which R is a linear or branched C 1 -C 8  alkylene or a linear or branched C 1 -C 12  alkane; 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.  
       
     
     
         25 . The composition of  claim 18 , wherein the macromer further comprises pendant modifier groups.  
     
     
         26 . The composition of  claim 18 , further comprising an active agent.  
     
     
         27 . The composition of  claim 18 , wherein the macromers form a hydrogel that is biodegradable.  
     
     
         28 . The composition of  claim 18 , further comprising a contrast agent.  
     
     
         29 . The composition of  claim 18 , further comprising a copolymerizable monomer.  
     
     
         30 . The composition of  claim 18 , wherein the crosslinkable groups are olefinically unsaturated groups.  
     
     
         31 . A method for tissue bulking or coating, comprising the steps: 
 providing a 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;    delivering the composition to the intended site of bulking or coating; and    crosslinking the macromers to form a hydrogel.    
     
     
         32 . The method of  claim 31 , wherein the backbone polymer comprises a polyhydroxy polymer.  
     
     
         33 . The method of  claim 31 , wherein the pendant chains bearing crosslinkable groups are attached to the backbone via the 1,2-diol or 1,3-diol groups.  
     
     
         34 . The method of  claim 33 , wherein the pendant chains bearing crosslinkable groups are attached to the backbone via cyclic acetal linkages.  
     
     
         35 . The method of  claim 31 , wherein the polymer comprises poly(vinyl alcohol) (PVA) and copolymers thereof.  
     
     
         36 . The method of  claim 31 , wherein the macromer comprises units having the formula:  
       
         
           
           
               
               
           
         
         in which R is a linear or branched C 1 -C 8  alkylene or a linear or branched C 1 -C 12  alkane; 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.  
       
     
     
         37 . The method of  claim 31 , wherein the macromer further comprises pendant modifier groups.  
     
     
         38 . The method of  claim 31 , further comprising administering an active agent.  
     
     
         39 . The method of  claim 38 , wherein the active agent is a chemotherapeutic agent.  
     
     
         40 . The method of  claim 38 , wherein the active agent is encapsulated in the hydrogel and the hydrogel releases the agent over a period of time ranging from about 1 day to 6 months.  
     
     
         41 . The method of  claim 31 , wherein the hydrogel is biodegradable.  
     
     
         42 . The method of  claim 31 , further comprising administering a contrast agent.  
     
     
         43 . The method of  claim 31 , wherein the composition further comprises a copolymerizable monomer.  
     
     
         44 . The method of  claim 31 , wherein the crosslinkable groups are crosslinkable via free radical polymerization.  
     
     
         45 . The method of  claim 44 , wherein the crosslinkable groups are olefinically unsaturated groups.  
     
     
         46 . The composition of  claim 44 , wherein the free radical polymerization is redox initiated.  
     
     
         47 . The method of  claim 31 , wherein the macromers are crosslinked into a hydrogel prior to delivery of the composition.  
     
     
         48 . The method of  claim 31 , wherein the macroiners are crosslinked in situ.  
     
     
         49 . The method of  claim 46 , wherein the macromers are crosslinked via redox initiated free radical polymerization and the composition comprises a first component comprising a reductant and a second component comprising an oxidant wherein the macromers are present in either or both components.  
     
     
         50 . A tissue bulking composition comprising hydrogel articles formed from macromers.  
     
     
         51 . The composition of  claim 50 , wherein the 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 macromers are crosslinked to form a hydrogel.  
     
     
         52 . The composition of  claim 51 , wherein the backbone polymer comprises a polyhydroxy polymer.  
     
     
         53 . The composition of  claim 51 , wherein the pendant chains bearing crosslinkable groups are attached to the backbone via the 1,2-diol or 1,3-diol groups.  
     
     
         54 . The composition of  claim 53 , wherein the pendant chains bearing crosslinkable groups are attached to the backbone via cyclic acetal linkages.  
     
     
         55 . The composition of  claim 51 , wherein the polymer comprises poly(vinyl alcohol) (PVA) and copolymers thereof.  
     
     
         56 . The composition of  claim 50 , wherein the macromer comprises units having the formula:  
       
         
           
           
               
               
           
         
         in which R is a linear or branched C 1 -C 8  alkylene or a linear or branched C 1 -C 12  alkane; 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.  
       
     
     
         57 . The composition of  claim 51 , wherein the macromer further comprises pendant modifier groups.  
     
     
         58 . The composition of  claim 50 , further comprising an active agent.  
     
     
         59 . The composition of  claim 50 , wherein the hydrogel is biodegradable.  
     
     
         60 . The composition of  claim 50 , further comprising a contrast agent.  
     
     
         61 . The composition of  claim 51 , wherein the crosslinkable groups are crosslinked via free radical polymerization.  
     
     
         62 . The composition of  claim 61  wherein the crosslinkable groups are olefinically unsaturated groups.  
     
     
         63 . The composition of  claim 61 , wherein the free radical polymerization is redox initiated.  
     
     
         64 . The composition of  claim 50 , wherein the hydrogel articles are microspheres.  
     
     
         65 . The composition of  claim 56 , wherein the hydrogel articles are microspheres.  
     
     
         66 . A method for tissue bulking comprising administering the preformed articles of  claim 50 .  
     
     
         67 . A method for tissue bulking comprising administering the preformed articles of  claim 66 .  
     
     
         68 . A method for tissue bulking or coating comprising administering the composition of  claim 1 .  
     
     
         69 . A method for tissue bulking or coating comprising administering the composition of  claim 18.

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