Pre-filled Syringe Formatting System for Antibiotic Paste
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Solution Overview
Problem
Current medical devices for preventing surgical infections do not incorporate antibiotics, leading to extra steps and resource consumption in the operating room, and existing methods for preparing antibiotic beads are cumbersome and time-consuming.
Innovation Solution
A formatting system for a medical device that includes two syringes, one with calcium sulfate and the other with water and antibiotics like Vancomycin and Gentamicin, connected via a luer lock mechanism, allowing for rapid mixing and application of a paste to prevent surgical infections.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If antibiotics are pulled from the hospital pharmacy and mixed manually in a small bowl, then the surgeon can prepare antibiotic beads for infection prevention, but this process consumes critical time (10-15 minutes for setup plus 6-7 minutes for spreading), requires multiple steps, and creates spillage risks
Solution Approach 1:
The syringes are pre-filled with antibiotics (Vancomycin and Gentamicin) and calcium sulfate powder before sterilization, so that during surgery the surgeon only needs to connect the syringes and mix the contents. This preliminary preparation eliminates the time-consuming steps of manually retrieving antibiotics from pharmacy, measuring dosages, and mixing in open bowls during the surgical procedure.
Solution Approach 2:
The patent introduces a sterile connector as an intermediary component that joins the two pre-filled syringes. This connector enables the mixing process to occur in a closed, sterile system rather than requiring open-bowl manual mixing, thereby reducing preparation time and eliminating spillage while maintaining sterility throughout the process.
2Ease of manufacture
If antibiotics are manually mixed in a small open bowl during surgery, then the surgeon can create antibiotic beads, but this open process creates spillage and contamination risks while consuming considerable time
Solution Approach 1:
The patent uses sealed syringes with flexible barrels to contain the antibiotics and calcium sulfate powder during storage and transport. When connected, the syringes form a closed mixing system that prevents spillage and maintains sterility, eliminating the need for open-bowl mixing while keeping the preparation process simple and intuitive.
Solution Approach 2:
The syringes are sterilized as complete assemblies including the connectors, creating a sterile, controlled environment for the antibiotics and calcium sulfate. This pre-sterilized closed system prevents contamination during the mixing process, eliminating the need for sterile technique during manual mixing while ensuring product sterility.
3Ease of operation
If the surgical technician estimates drug dosages for smaller sized kits without clearly defined protocols, then the preparation can be completed, but the correct amount of drugs cannot be ensured
Solution Approach 1:
The antibiotics and calcium sulfate are pre-measured and pre-filled into the syringes at controlled manufacturing conditions with precisely defined dosages. This eliminates the need for surgical technicians to estimate or calculate dosages during surgery, ensuring manufacturing precision is maintained while keeping the surgical preparation simple—only requiring connection and mixing of the pre-dosed syringes.
Data Source
AI summary
A formatting system for a medical device for preventing surgical infection is disclosed, including a kit comprising a formatting system. The formatting system includes a first syringe having a sufficient amount of calcium sulfate and a second syringe including a sufficient amount of water, the kit including a case to provide a protective and sterile housing. A sterile tray is molded to an interior of the case to provide a mixing vessel to mix at least one medication with the sufficient amount of water via a mixing device. The second syringe and the first syringe are connectable to permit the mixing the of the at least one medication, the sufficient amount of water, and the calcium sulfate to form a paste. An elongated tip facilitates the application of the paste to a patient.