There is controversy about the use of polytetrafluoroethylene (Teflon) paste in children for the endoscopic treatment of vesicoureteral reflux due to evidence of particle migration. However, there are definite advantages in treating patients endoscopically. It is evident that the ideal substance should be able to be delivered endoscopically, conserve its volume, and be nonmigratory and nonantigenic. Towards this goal we developed a catheter with an inflatable, detachable and self-sealing silicone balloon that would fit through a 19 gauge cystoscopic needle. Hydroxy-ethyl-methyl acrylate, a hydrophilic polymer that solidifies within 60 minutes after the addition of ferrous sulfate, was chosen as the filling material for the balloon. Conceptually, the sealed balloon would prevent the migration of hydroxy- ethyl-methyl acrylate and the solidified polymer would prevent volume loss. To test this system reflux was created in 6 Hanford mini-pigs by unroofing the ureters bilaterally. In 2 pigs a previously described method of open surgery was used and in the other 4 reflux was created endoscopically using the resectoscope and laparoscopic scissors. The presence of bilateral reflux was confirmed 4 weeks later with a cystogram and the balloon was implanted unilaterally through a cystoscope. The opposite ureter served as an internal control in all animals. A repeat cystogram was performed 2 to 4 weeks after implantation, demonstrating resolution of reflux in the treated side and persistence of reflux in the opposite untreated ureter. Serial cystograms, ultrasound and excretory urography showed no reflux on the implanted side nor any evidence of obstruction. Tissue sections from various organs showed no evidence of particle migration, granuloma formation or inflammatory reaction. Short-term results show that the balloon implants are able to correct reflux without evidence of obstruction.
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