A new design paradigm for the development of custom-fit soft sockets for lower limb prostheses

This paper presents a new 3D design paradigm for the development of specific custom-fit products, such as the soft socket of prostheses for lower limb amputees. It is centered on the digital model of the human body and, contrarily to the traditional process almost manually based, it considers the integration of methods and tools coming from different research and application fields: Reverse Engineering, Medical Imaging, Virtual Prototyping, Physics-based Simulation, and Rapid Prototyping. The paper describes the techniques adopted to acquire and create the digital model of the residual limb, the procedure to generate the socket model, the strategy developed for the functional simulation of the socket-stump interaction and, finally, the realization of the physical prototype. Each design step is described with the related problems and the obtained results. Both trans-tibial and trans-femoral amputees have been considered; however, for now the complete process has been validated for trans-tibial prostheses. Major outcomes of the proposed approach stand in a better quality of the final product, in a shorter involvement of the amputee implying a lower psychological impact, in a limited use of physical prototypes, and in a shorter development time. Moreover, the resulting paradigm answers to the Collaborative Engineering guidelines by optimizing the interaction between different domains and enhancing their contributions in a homogeneous development framework.