Bulking agent

Abstract

The invention relates to bulking agents and apparatus and methods for using the disclosed bulking agents. The bulking agents can be used to treat such conditions as urinary and fecal incontinence, gastro-esophageal reflux, aneurismal blockages, and cosmetic deformities. The invention also relates to an injection method that reduces the injection pressure required to place the bulking agents.

What is claimed is:  
     
         1 . A bulking agent for medical applications comprising: 
 a carrier; and    a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier, the carrier aiding delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked.    
     
     
         2 . The bulking agent of  claim 1  wherein the bulking agent comprises a volume from about 1 ml to about 30 ml.  
     
     
         3 . The bulking agent of  claim 1  wherein the bulking agent comprises a volume from about 20 ml to about 30 ml.  
     
     
         4 . The bulking agent of  claim 1  wherein the bulking agent comprises a volume from about 2 ml to about 16 ml.  
     
     
         5 . The bulking agent of  claim 1  wherein at least some of the substantially spherical polyvinyl alcohol particles are sized from about 40 micron to about 1500 microns in diameter.  
     
     
         6 . The bulking agent of  claim 1  wherein at least some of the substantially spherical polyvinyl alcohol particles are sized from about 150 micron to about 1100 microns in diameter.  
     
     
         7 . The bulking agent of  claim 1  wherein at least some of the substantially spherical polyvinyl alcohol particles are sized from about 500 micron to about 900 microns in diameter.  
     
     
         8 . The bulking agent of  claim 1  wherein at least some of the substantially spherical polyvinyl alcohol particles comprise pores.  
     
     
         9 . The bulking agent of  claim 1  wherein at least some of the substantially spherical polyvinyl alcohol particles are compressible.  
     
     
         10 . The bulking agent of  claim 1  wherein at least some of the substantially spherical polyvinyl alcohol particles are substantially dimensionally stable.  
     
     
         11 . The bulking agent of  claim 1  wherein at least some of the substantially spherical polyvinyl alcohol particles comprise at least one bioreactive agent selected from the group consisting of a drug, a protein, a gene, a chemo-therapeutic agent, and a growth factor.  
     
     
         12 . The bulking agent of  claim 1  wherein the substantially spherical polyvinyl alcohol particles comprise a lubricant.  
     
     
         13 . The bulking agent of  claim 1  wherein the carrier comprises a compound selected from the group consisting of a water-based solution, a lubricant, and a biocompatible thickening agent.  
     
     
         14 . A method for bulking mammalian tissue comprising the steps of: 
 introducing a bulking agent to the mammalian tissue, the bulking agent comprising: 
 a carrier, and  
 a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier, the carrier aiding delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked; and  
   coapting the mammalian tissue with the substantially spherical polyvinyl alcohol particles.    
     
     
         15 . The method of  claim 14  further comprising the step of viewing the tissue to be bulked during the introducing step.  
     
     
         16 . The method of  claim 14  wherein the bulking agent comprises a volume from about 1 ml to about 30 ml.  
     
     
         17 . The method of  claim 14  wherein at least some of the substantially spherical polyvinyl alcohol particles are sized from about 40 micron to about 1500 microns in diameter.  
     
     
         18 . An apparatus for bulking mammalian tissue comprising: 
 a needle defining a lumen, the needle adapted to penetrate the mammalian tissue;    an inflation device adapted to advance through the lumen of the needle and disposable adjacent to the mammalian tissue, where the inflation device is inflatable and subsequently deflatable to create a void in the mammalian tissue; and    a bulking agent insertable via the lumen of the needle to at least partially fill the void in the tissue.    
     
     
         19 . The apparatus of  claim 18  wherein the inflation device comprises a biocompatible balloon.  
     
     
         20 . The apparatus of  claim 18  wherein the inflation device comprises a color coating for visualization.  
     
     
         21 . The apparatus of  claim 18  wherein the inflation device comprises at least one of a silicone, an ethylene vinyl alcohol, a polypropylene, a latex rubber, a polyurethane, a polyester, a nylon, and a thermoplastic rubber.  
     
     
         22 . The apparatus of  claim 18  wherein the inflation device comprises a shape selected from the group consisting of substantially round, oval, hemi spherical, spherical, and oblong.  
     
     
         23 . The apparatus of  claim 18  wherein the bulking agent comprises a plurality of polymeric particles.  
     
     
         24 . The apparatus of  claim 18  wherein the bulking agent is injected into the void by a syringe.  
     
     
         25 . The apparatus of  claim 18  wherein the bulking agent comprises: 
 a carrier, and  
 a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier, the carrier aiding delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked.  
 
     
     
         26 . The apparatus of  claim 18  wherein the bulking agent comprises a color.  
     
     
         27 . The apparatus of  claim 18  wherein the needle is sized from 16 gauge to 24 gauge.  
     
     
         28 . A method for bulking mammalian tissue comprising the steps of: 
 inserting an inflation device within a portion of a mammal;    inflating the inflation device to compress the mammalian tissue surrounding the inflated inflation device, thereby creating a void in the tissue;    deflating the inflation device;    removing the inflation device from the mammal; and    providing a bulking agent to fill at least partially the void.    
     
     
         29 . The method of  claim 28  further comprising the steps of: 
 inserting a needle with a penetration device into the mammalian tissue;  
 removing the penetration device while retaining the inserted needle; and  
 advancing the inflation device through the needle.  
 
     
     
         30 . The method of  claim 28  wherein the inflation device comprises a color for visualization.  
     
     
         31 . The method of  claim 28  wherein the inflation device comprises at least one of a silicone, an ethylene vinyl alcohol, a polypropylene, a latex rubber, a polyurethane, a polyester, a nylon, and a thermoplastic rubber.  
     
     
         32 . The method of  claim 28  wherein the inflation device comprises a shape selected from the group consisting of substantially round, oval, hemi spherical, spherical, and oblong.  
     
     
         33 . The method of  claim 28  wherein the bulking agent comprises: 
 a carrier, and  
 a plurality of substantially spherical polyvinyl alcohol particles dispersed within the carrier, the carrier aiding delivery of the substantially spherical polyvinyl alcohol particles to a site to be bulked.