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, biologically compatible restorative composition comprising
 sterilizing a filler coated with a silane using gamma radiation, E beam, ethylene oxide, or a combination thereof;   sterilizing at least one monomer using high pressure filtration; and   aseptically combining the filler coated with the silane and the monomer within a delivery vessel to form the restorative composition.   
   
   
       2 . The method of  claim 1 , wherein the filler is barium glass, barium-boroaluminosilicate glass, silica, 45S5 glass, bioactive glass, ceramics, glass-ceramics, bioactive synthetic combeite glass-ceramic, or a combination thereof. 
   
   
       3 . The method of  claim 1 , wherein the silane is γ-methyacryloxypropyltrimethoxysilane. 
   
   
       4 . The method of  claim 1 , wherein the filler coated with the silane is sterilized using gamma radiation. 
   
   
       5 . The method of  claim 1 , wherein the filler coated with the silane is sterilized using E beam. 
   
   
       6 . The method of  claim 1 , wherein the filler coated with the silane is sterilized using ethylene oxide. 
   
   
       7 . The method of  claim 1 , wherein the at least one monomer is bisphenol-A-diglycidyl methacrylate, triethyleneglycol dimethacrylate, diurethane dimethacrylate, bisphenol-A-ethyl methacrylate, or a combination thereof. 
   
   
       8 . The method of  claim 1 , wherein the filler coated with the silane has a sterility assurance level of at least 10 −6  after sterilization. 
   
   
       9 . The method of  claim 1 , wherein the filler coated with the silane has a sterility assurance level of at least 10 −3  after sterilization.