Sterile Polymerizable Systems And Kits And Methods Of Their Manufacture And Use

Abstract

The present invention overcomes the difficulties in the sterilization and delivery of viscous, multi-component compositions that require pre-mixing prior to usage by disclosing a sterile, multi-component, ready-to-use product wherein each component is sterilized independently and then assembled into a sterilized delivery kit. In certain preferred embodiments of the present invention, a sterile, polymerizable system is provided that comprises a plurality of sterile polymerizable monomers, said monomers having been sterilized by passing them through a filter; at least one sterile filler which has been exposed to conditions effective to render said filler sterile, and the sterile monomers and the sterile filler being blended together to form at least one substantially homogeneous blend contained within a sterile delivery vessel. Still other embodiments include a single-use kit that comprises a delivery gun, mix tips, and cartridges that comprise one or more pastes of the present invention that are housed within one or more pouches to ensure sterility of the internal contents.

1 . A method of preparing a sterile, polymerizable blend, the method comprising:
 exposing at least one filler, said filler having been at least partially coated with a coupling agent, to dry heat for a time and at a temperature sufficient to render the at least one filler sterile and maintain the integrity of the coating; and   combining the filler with at least one monomer.   
   
   
       2 . The method of  claim 1 , wherein the filler is bioactive glass, bioactive glass-ceramic, barium glass, barium-boroaluminosilicate glass, silica, or combinations thereof. 
   
   
       3 . The method of  claim 1 , wherein the coupling agent is silane. 
   
   
       4 . The method of  claim 1  wherein the filler is sterilized at a temperature of about 121° C. for at least 8 hours. 
   
   
       5 . The method of  claim 1  wherein the filler is sterilized at a temperature of about 140° C. for at least 6 hours. 
   
   
       6 . A method of preparing a sterile, biologically compatible restorative composition, the method comprising:
 exposing at least one filler, said filler having been at least partially coated with a coupling agent, to dry heat for a time and at a temperature sufficient to render the at least one filler sterile and maintain the integrity of the coating.   
   
   
       7 . The method of  claim 6 , wherein the filler is bioactive glass, bioactive glass-ceramic, barium glass, barium-boroaluminosilicate glass, silica, or combinations thereof. 
   
   
       8 . The method of  claim 6 , wherein the coupling agent is silane. 
   
   
       9 . A method of restoring osseous tissue in an animal, the method comprising:
 exposing at least one filler, said filler having been at least partially coated with a coupling agent, to dry heat for a time and at a temperature sufficient to render the at least one filler sterile and maintain the integrity of the coating;   combining the filler with at least one sterile monomer to form at least one sterile polymerizable restorative composition;   containing the sterile polymerizable restorative composition into a sterile delivery vessel; and   delivering the sterile polymerizable restorative composition from the sterile delivery vessel to an osseous defect in the animal.   
   
   
       10 . The method of  claim 9 , wherein the filler is bioactive glass, bioactive glass-ceramic, barium glass, barium-boroaluminosilicate glass, silica, or combinations thereof. 
   
   
       11 . The method of  claim 9 , wherein the coupling agent is silane. 
   
   
       12 . A method of preparing a sterile, polymerizable blend, the method comprising:
 exposing at least one filler, said filler having been at least partially coated with a coupling agent, to gamma radiation, E beam radiation, light, or ethylene oxide under conditions sufficient to render the at least one filler sterile and maintain the integrity of the coating; and   combining the filler with at least one monomer.   
   
   
       13 . The method of  claim 12 , wherein the filler is bioactive glass, bioactive glass-ceramic, barium glass, barium-boroaluminosilicate glass, silica, or combinations thereof. 
   
   
       14 . The method of  claim 12 , wherein the coupling agent is silane.