Pearls and Pitfalls in an Innovative Approach to Trismus Management

Objectives: Restricted jaw opening (trismus) affects roughly 47% of patients who undergo radiotherapy for head and neck cancer, and can greatly impact on their quality of life. Moderate to severe trismus impairs mastication, decreases nutrition, and makes access to the oral cavity difficult hampering oral hygiene. A range of commercial devices have demonstrated significant functional benefit in the treatment of trismus. Major barriers to the use of these devices include significant cost and poor patient fit. Through identification of this clinical problem and collaborating with an in-house biomedical engineering team, we aimed to produce a cost effective medical device that provided better patient fit and could be distributed open-source, allowing treatment of patients around the world at minimal cost.
Methods: A literature review and evaluation of current commercially available products were conducted by the study team, in collaboration with the investigating biomedical engineer. Key design elements were noted. Post-graduate students were then invited to design a novel device that would encompass these key design elements, could be distributed by open-source, 3-D printed locally and address issues of cost and patient fit.
Results: The team was successful in developing a prototype trismus device, capable of addressing the key clinical issues of cost and fit. The device has been developed such that it is able to be distributed open-source.
Conclusions: This presentation aims to discuss the pearls and pitfalls involved in the process of bringing a concept to a tangible outcome, the benefits of having an in-house biomedical engineering facility, and the challenges that open-source engineering may create in the current legal framework.