3D interactive environment for the design of medical devices

The effectiveness of custom-made prostheses or orthoses heavily depends on the experience and skills of the personnel involved in their production. For complex devices, such as lower limb prosthesis, a conventional manual approach affects the process at the point that the result is frequently not acceptable at the first trial. The paper presents a computer-aided environment, named socket modelling assistant 22 (i.e., SMA2) , to interactively design the socket of lower limb prosthesis by implementing a set of design rules extrapolated from the traditional development process. The new computer-aided environment has been implemented embracing a low-cost philosophy and using open source libraries to provide a solution affordable also by small orthopaedic laboratories. The system permits to modify and interact with the 3D model of residual limb to create the socket geometric model ready to be manufactured by means of additive manufacturing. SMA2embeds medical knowledge related to the device functioning, the conventional process and the way orthopaedic technicians work so that it can be much more reliable and repeatable compared to the conventional process, but still enough similar to it to be accepted by the involved personnel. In the paper, the new 3D design procedure is described in detail, from the acquisition of patient’s data to preliminary and customized modelling, and new geometric tools to perform context–related operations are shown. A case study is used to clarify the way the system works and to provide an example of the outcome.