The ampoules are usually opened by snapping off the neck, which should theoretically create a clean break without any extra glass shards or slivers. Realistically, some number of shards and sharp slivers are always present, where in lies the problem. The ampoules pose a cutting hazard to technicians opening the ampoules. Additionally, shards of glass can be transferred from the ampoule into the bone cement mix. These shards, although harmless, are visible on post-op x-rays.

Solution: TPD designed and developed a plastic sheathwith bellows that slid over the glass ampoule. When the technician breaks the ampoule during use, the shards and sharp slivers would be contained in the bellows of the sheath protecting the user. Additionally, the pour spot was filtered to eliminate shards of glass being transferred into the bone cement mix.

Design Challenges: Creating a one piece assembly that was cost effective, intuitive and could be assembled in existing packaging lines and packaging. Additionally, selecting a material(s) that were biocompatible and had the mechanical properties that allow it to be used with the monomer, be flexible enough for a bellows and be puncture resistanc