Sterile Polymerizable Systems And Kits And Methods Of Their Manufacture And Use
First Claim
1. A method of preparing a sterile, biologically compatible restorative composition comprisingsterilizing 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.
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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.
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9 Claims
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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Specification