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This study aims to integrate design methods and additive manufacturing with the use of a thermoplastic elastomer certified for medical use and reverse engineering towards a new concept of a customized buttress model with optimized features for the reconstruction of the osteo-dural opening after endoscopic endonasal transtuberculum-transplanum approach.

Additive manufacturing allows making of cost-effective and useable devices with tailored properties for biomedical applications. The endoscopic endonasal approach to the suprasellar area enables the management of different intradural tumours, and the craniectomy at the skull base is generally wide and irregular. Defining an optimal strategy for osteodural defect closure at the preoperative stage represents a significant challenge.

Using the results obtained from a computed tomography analysis, skull base defects were designed to plan the surgical approach. Several concepts of customized buttress models were first built up, initially focusing on thin, flexible edges characterized by different thicknesses. Finite element analyses and design optimization allowed us to achieve the optimal design solution with improved compliance/flexibility for easy intranasal manoeuvrability, maintaining an adequate mechanical stability. As the thickness of the edges decreased, an increase of strain energy values was found (i.e. 1.2 mJ – Model A, 1.7 mJ – Model B, 2.3 mJ – Model C, 4.3 mJ – Model D). However, a further optimization (Model E) led to a significant increase of the compliance (strain energy of 14.1 mJ).

The results obtained from clinical evaluations demonstrated the feasibility of the proposed technical solutions, improving surgery effectiveness.