Design for Disability: Prosthetic BK Socket's Manufacturing with New Digital Methodology

This study presents the definition and validation of a new process methodology for the creation of sockets for transtibial amputations and has the objective of automating and digitizing the prosthesis production process through digital transformation activities of the orthopedic workshop, additive manufacturing and advanced manufacturing solutions, as well as simulation for Gait analysis.The work is part of an interdisciplinary project which sees, in addition to the experience of the orthopedic technician, the involvement of the mechanical engineer, the biomedical engineer and the designer.The elements of digital innovation concern: the acquisition of the digital 3D model of the stump through scanning with the scanner and MRI; physically based modeling and FEM simulation of the stump to obtain the "compressed and stylized" model through new quantitative rules developed by the work team; rapid prototyping of the 3D model of the stump; the autoclave lamination process of prepreg fabrics or the socket printed directly in 3D thanks to the use of innovative printers; the acquisition of 3D models of leg, foot and cover foot or leg for the creation of customized parts; static and dynamic alignment; validation of the prosthesis via Gait analysis; monitoring the patient's health status during the life of the device supplied with the Gait analysis system.The innovations made and the new methodology certainly revolutionize an obsolete sector and speedup the creation of prostheses, with aspects of eco-innovation of the product and process and with significant energy savings.In this context, "inclusive" design aims to allow all disabled people to have equal opportunities for participation in every aspect of social and cultural life, thanks to innovative prostheses that improve the quality of their life.This holistic and innovative approach constitutes a creative and ethical challenge for all designers because human diversity, social inclusion and equality are aspects to be considered in the design process, enhancing human needs and aspirations.To achieve this, end-user involvement is required at every stage of the design process.Furthermore, technological innovation brings benefits for everyone and competitive and economic advantages, since the possibility of remotely producing the orthopedic prosthesis customized for each patient makes the technology accessible to users, guaranteeing high technology at low costs.The methodology was tested on seven patients with transtibial amputation: the results obtained and the final considerations can be considered satisfactory.Future research, in this way, can increase the fields of application using the same digital methodologies.