Development and safety study of a 3D printed middle turbinate splint

Abstract

Adhesion of the middle turbinate to the lateral wall of the nasal cavity and synechia of the middle meatus are one of the common reasons for the failure of surgical interventions for chronic sinusitis. The use of specially shaped intranasal splints can solve the problem of preventing synechiae in the postoperative period. Many different devices and approaches have been proposed to prevent the development of this category of complications. This study proposes an anatomical version of the splint for the middle turbinate, developed using 3D computer modeling technologies followed by printing from a biocompatible elastic material on a Formlabs 3BL 3D printer. The shape and size of the splint were developed based on the analysis of computed tomography data of 50 adult patients. The safety of the developed device was studied in a group of 20 volunteers in whom the developed splint was installed on one side of the nasal cavity for 2 weeks after bilateral surgery. According to endoscopic examination and patient questionnaires, the developed splint did not cause local or systemic allergic reactions and did not create additional discomfort for the patient in the postoperative period. Installing a splint helped prevent the formation of synechiae. However, to determine clinical effectiveness, a study with a larger sample of patients is required.