*Article* **A Structured Approach for the Design and Manufacturing of Titanium Cranial Prostheses via Sheet Metal Forming**

**Gianfranco Palumbo 1, \* , Giuseppina Ambrogio 2 , Alberto Crovace 3 , Antonio Piccininni 1 , Angela Cusanno 1 , Pasquale Guglielmi 1 , Luigi De Napoli <sup>2</sup> and Giuseppe Serratore 2**


**Abstract:** Currently, the growing need for highly customized implants has become one of the key aspects to increase the life expectancy and reduce time and costs for prolonged hospitalizations due to premature failures of implanted prostheses. According to the literature, several technological solutions are considered suitable to achieve the necessary geometrical complexity, from the conventional subtractive approaches to the more innovative additive solutions. In the case of cranial prostheses, which must guarantee a very good fitting of the region surrounding the implant in order to minimize micromotions and reduce infections, the need of a product characterized by high geometrical complexity combined with both strength and limited weight, has pushed the research towards the adoption of manufacturing processes able to improve the product's quality but being fast and flexible enough. The attention has been thus focused in this paper on sheet metal forming processes and, namely on the Single Point Incremental Forming (SPIF) and the Superplastic Forming (SPF). In particular, the complete procedure to design and produce titanium cranial prostheses for in vivo tests is described: starting from Digital Imaging and COmmunications in Medicine (DICOM) images of the ovine animal, the design was conducted and the production process simulated to evaluate the process parameters and the production set up. The forming characteristics of the prostheses were finally evaluated in terms of thickness distributions and part's geometry. The effectiveness of the proposed methodology has been finally assessed through the implantation of the manufactured prostheses in sheep.

**Keywords:** Ti-6Al-4V ELI; superplastic forming; single point incremental forming; custom prosthesis; in vivo tests
