ABSTRACT
Removable nasal obturators provide a treatment option for a range of patients presenting with velopharyngeal dysfunction without eliminating the possibility for future surgery, speech therapy, or the provision of other devices. The presented technique describes the fabrication of a 1-piece silicone nasal obturator to reduce hypernasality and nasal airflow errors without causing significant hyponasality. The obturator has minimal visibility and minimal risk of inhalation.
Subject(s)
Cleft Palate , Velopharyngeal Insufficiency , Humans , Velopharyngeal Insufficiency/surgery , Velopharyngeal Insufficiency/etiology , Nose , Cleft Palate/complicationsABSTRACT
The World Health Organisation has called for a 40% increase in personal protective equipment manufacturing worldwide, recognising that frontline workers need effective protection during the COVID-19 pandemic. Current devices suffer from high fit-failure rates leaving significant proportions of users exposed to risk of viral infection. Driven by non-contact, portable, and widely available 3D scanning technologies, a workflow is presented whereby a user's face is rapidly categorised using relevant facial parameters. Device design is then directed down either a semi-customised or fully-customised route. Semi-customised designs use the extracted eye-to-chin distance to categorise users in to pre-determined size brackets established via a cohort of 200 participants encompassing 87.5% of the cohort. The user's nasal profile is approximated to a Gaussian curve to further refine the selection in to one of three subsets. Flexible silicone provides the facial interface accommodating minor mismatches between true nasal profile and the approximation, maintaining a good seal in this challenging region. Critically, users with outlying facial parameters are flagged for the fully-customised route whereby the silicone interface is mapped to 3D scan data. These two approaches allow for large scale manufacture of a limited number of design variations, currently nine through the semi-customised approach, whilst ensuring effective device fit. Furthermore, labour-intensive fully-customised designs are targeted as those users who will most greatly benefit. By encompassing both approaches, the presented workflow balances manufacturing scale-up feasibility with the diverse range of users to provide well-fitting devices as widely as possible. Novel flow visualisation on a model face is presented alongside qualitative fit-testing of prototype devices to support the workflow methodology.