DEVELOPMENT OF A DETACHABLE NASAL STENT TO FACILITATE NASOALVEOLAR MOLDING
Franz Bauer1, Hannes Dikel1, Markus Eblenkamp1, Florian Guell D2, Denys J Loeffelbein2
1Institute of Medical and Polymer Engineering,
2Technical University of Munich, Germany
Nasoalveolar Molding (NAM) allows to presurgically treat Cleft Lip and Palate, one of the most frequent facial deformities. It aims to reduce and facilitate surgical interventions by reducing the cleft gap and lifting the flattened nose wing. Therefore, a patientindividual palatal plate promotes the growth of the alveolar segments towards a harmonic alveolar ridge. After the reduction of the cleft gap below 6 mm, the nasal stent is added to the plate to erect the flattened nostrils towards a natural nose wing occurrence. During the treatment of 3 to 4 month the palatal plate and the nasal stent have to be adjusted by replacing the plate within the range of 3 to 4 weeks by a bigger one according to the infant’s growth. The nasal stent can be adjusted by deforming the stainless steel wire, connecting the nasal stent with the plate. Hence, the nasal stent can be reused for each plate.
Therefore, an interface for a detachable nasal stent was developed as a three-part device: a connector pin integrated in the plate, a nasal stent and a nut to fixate the nasal stent to the plate. The bent wire is plugged into the connector pin and fixated by the nut, to prevent the nasal stent from moving. The plate with the integrated pin and the nut were manufactured using the PolyJet©-Photopolymer MED610. The material is licensed under USP, Class VI.
The connection system allows a quick and easy change from one to the next plate, instead of the time-consuming attaching process of the wire by polymerizing. The design and handling was evaluated by clinicians to be easy in handling and equivalent to the traditional device.