FlushCut: A Reusable Intra-Operative Precision Cutting System

FlushCut is a simple, intra-operative tool that facilitates mandibular reconstruction surgery for head and neck surgeons, improving efficiency and yielding successful surgical outcomes. In the United States, 50,000 oral cancer patients are treated annually. Surgical treatment often requires the removal of the tumor from the mandible and replacement with a reconstructed fibula bone. Complete or partial mandibular reconstruction may also be required in treating facial fractures, which comprise about 250,000 cases yearly. Reconstruction requires a head and neck surgeon to remove the section of the mandible that needs to be replaced. The majority of surgeons do so by using the “freehand method” of a tongue depressor or ruler to mark and measure the cuts needed for bony reconstruction. The surgeon then estimates cuts along the fibula to resemble the missing mandibular portion, a process that lengthens and introduces error into an already long and strenuous surgery. This process can negatively affect long-term patient outcomes including the ability to speak, eat and smile. All currently available technique alternatives are either less precise or considerably more expensive. To address the limitations of the current approach to mandibular reconstruction, we propose the development of FlushCut – a mechanical tool that allows surgeons to efficiently make precise reconstructive cuts in surgery. FlushCut is an accessible product for use by head and neck surgeons to individualize reconstructive measures to a patient’s specific problem. This tool will allow for reduction of operative time by 60 minutes, yielding $3,500 - $5,000 savings per case from time savings alone. Its use may greatly improve aesthetic and functional results to optimize patient outcomes and satisfaction. B) Over the course of the grant period, our team plans to finalize our concept for the FlushCut. This includes prototype development, manufacturing, beta-testing with model fibular bones, sterilizing for surgical use, trialing use in surgery and, ultimately, marketing. Clinical trials and FDA clearance as a class II medical device will be completed by the licensed medical company.

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Final paper and final poster available upon request.