Abbate, Valentina (2020) “New method of production of orthopedic back brace for the treatment of scoliosis through Additive Manufacturing techniques: an application case”. [Tesi di dottorato]

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The latest industrial revolution, Industry 4.0, is encouraging the integration of intelligent production systems and advanced information technologies. Additive manufacturing (AM) is considered to be an essential ingredient in this new movement. In the medical sector use of scanning technologies combined with computer aided design (CAD) and AM are gaining attention in the fabrication of customized medical devices, implants and products. Particularly, in orthopedic the patient-specific analysis is essential to obtain an accurate medical imaging data of the individual patient. Building end-use functional parts, like back brace for scoliosis, with additive manufacturing (AM) technologies is a challenging task and it will be described in the present work. This aim of the present thesis is the design and fabrication of a customized orthopedic back brace by Additive Manufacturing technique. Chapter 1 provides an analysis of Industry 4.0 and how it is changing the industrial scenario in Europe. AM is considered to be an essential ingredient in this new movement and the author provides a comprehensive review on AM technologies together with its contributions to Industry 4.0 and potential uses. In particular, the authors focus its attention on the possible application of AM in the medical field. Chapter 2 gives an overview on idiopathic scoliosis with a focus on the commercial back braces present on the market. Moreover, the authors proposed a comparison between three different manufacturing processes for back brace: the old, the present and the proposed approach. In particular, the proposed approach is based on the combination of 3D medical imaging and AM technologies to realize customized back braces for scoliosis. Chapter 3 describes in details the methods to design and manufacture an orthopedic back brace from the material testing to the final back brace design and manufacturing. Mechanical, thermal and morphological properties of two commercial polymers (PLA and PETG) have been investigated to determine the best 3D printer material for developing the back brace. Starting from the patient imaging an orthopedic back brace have been designed by dedicated software (Rodin4D). Fused deposition modeling (FDM) have been selected for the realization of the back brace due to its ease of use and the possibility to have a wide range of processable materials. Finally, Chapter 4 reports the pre-clinical trial of the realized back braces on ten patients in collaboration with the orthopedic clinic “La Nostra Famiglia - Eugenio Medea” of Bosisio Parini (Lecco). The pre-clinical investigation is a pilot study that will involve pediatric patients suffering from rachis alterations (idiopathic scoliosis and osteogenesis imperfecta) whose main objective will be the evaluation of the acceptance, safety and satisfaction of patients in the use of 3D printed back braces respect to the traditional ones with consolidated clinical effectiveness.

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