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 2 (i.e., SMA 2 ), 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. SMA 2 embeds 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.
Additive Manufacturing (AM) is not only an innovative approach of fabrication but it fosters a new paradigm to design products. The possibility to confer inhomogeneous properties to the product provides an important design key. This paper concerns the design and manufacture of medical devices that require a high level of customization. We focus the attention on lower limb prosthesis and in particular on the prosthetic socket. The proposed method is centered on the virtual modeling of patient’s residual limb and the virtual process is highly integrated and the data flow is as fluid as possible. Three main phases can be identified: design, validation and manufacture of the socket. Firstly, the technician uses the Socket Modeling Assistant (SMA) tool to design the socket shape. Then, a numerical simulation is run to check pressure distribution and validate the socket shape. Finally, a multi-material 3D printer is used to build the socket. Preliminary results are presented and conclusions are drawn concerning the challenge of multi-material 3D printing of the socket.
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