Sterile polymerizable systems and kits and methods of their...

A - Human Necessities – 61 – L

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A61L 2/04 (2006.01) A61L 2/00 (2006.01) A61L 2/02 (2006.01) A61L 2/07 (2006.01) A61L 2/08 (2006.01) A61L 2/20 (2006.01)

Patent

CA 2426591

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, polimerizable 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.

Le système selon l'invention permet de résoudre les difficultés de stérilisation et d'administration de compositions multicomposées visqueuses qui nécessitent d'être préalablement mélangées avant leur utilisation au moyen d'un produit prêt à l'utilisation, multicomposé et stérile, chaque composé du produit étant indépendamment stérilisé puis assemblé dans un nécessaire d'administration stérilisée. Dans certains modes de réalisation selon l'invention, un système polymérisable stérile comprend plusieurs monomères polymérisables stériles, ces monomères ayant été stérilisés après avoir été passés à travers un filtre ; au moins un excipient stérile qui a été exposé à des conditions suffisamment efficaces pour rendre ledit filtre stérile, les monomères stériles ainsi que ledit excipient stérile étant mélangés afin de former au moins un mélange sensiblement homogène versé dans un récipient d'administration stérile. D'autres modes de réalisation comprennent un nécessaire à usage unique qui comporte un pistolet d'administration, des extrémités de mélange, et des cartouches contenant au moins une pâte selon l'invention qui est logée à l'intérieur d'au moins une pochette afin d'assurer la stérilité des contenus internes.

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