Project Overview

Case: In the orthopedic operating room (OR), liquid bone cement monomers are stored in glass ampoules. These are mixed with bone cement monomer powder to form a polymer used to secure implants in place. Ampoules are typically opened by snapping off the neck, which should create a clean break without extra glass shards or slivers. In practice, shards and sharp slivers can occur, creating a cutting hazard for technicians. In addition, small glass shards may transfer into the bone cement mix. While generally harmless, they can be visible on post-op X-rays.

Solution: Tri-Power Design (TPD) designed and developed a plastic sheath with an integrated bellows that slides over the glass ampoule. When the technician breaks the ampoule during use, the bellows contains shards and sharp slivers to help protect the user. The pour spout was also filtered to reduce the chance of glass transferring into the bone cement mix.

Design Challenges: Create a one-piece, cost-effective assembly that is intuitive to use and compatible with existing packaging and packaging lines. Material selection also required biocompatibility and mechanical properties suitable for exposure to monomer, flexibility for the bellows, and puncture resistance.

Call 973.227.8214 or email us today to learn more about the Disposable Ampoule Cracker.