Nasal septal perforation (NSP) is a clinical condition characterized by tissue damage in the nasal septum creating communication between the nasal cavities. NSP can arise from pathological or iatrogenic causes and may significantly impact the patient’s quality of life. Treatment options include surgical closure or the use of septal buttons which occlude the perforation and reduce symptoms. Due to limited success rates of surgical treatment, septal buttons are a commonly used alternative. Since improper fit may worsen the condition, patient-specific septal buttons represent a promising solution.
The aim of this thesis was to develop a feasible in-house fabrication method for patient-specific septal buttons at the 3D Center at Karolinska University Hospital. The study included literature review, evaluation of current clinical workflow, development of an optimized in-house workflow, prototype development, silicone curing inhibition testing and a final fabrication evaluation. Product and manufacturing requirements were established to guide development.
The results showed that a feasible fabrication method could be established through iterative prototyping and material evaluation. Silicone curing inhibition associated with SLA printed molds was investigated and a compatible fabrication process was identified using BioMed White resin as mold material in combination with the high consistency silicone elastomer NuSil MED-4050. The final fabrication method enabled production of septal buttons adaptable to different perforation geometries and demonstrated the feasibility of in-house fabrication as an alternative to external manufacturing.
Further work is required before clinical implementation, including biocompatibility validation, optimization of final device and workflow and evaluation using real patient data.