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Selective laser sintering (SLS) is a powerful manufacturing technology that does not require part-specific tooling or significant human intervention and provides the ability to easily generate parts with complex geometric designs. The present work focuses on developing a manufacturing framework using this technology to produce subject-specific transtibial amputee prosthetic sockets made of Duraform PA, which is a nylon-based material. The framework includes establishing an overall socket design (using the patellar-tendon bearing approach), performing a structural analysis using the finite element method (FEM) to ensure structural reliability during patient use, and validating the results by comparing the model output with experimental data. The validation included quantifying the failure conditions for the socket through a series of bending moment and compression tests. In the case study performed, the FEM results were within 3% of the experimental failure loads for the socket and were considered satisfactory.

A very attractive advantage of manufacturing prosthetic sockets using solid freeform fabrication is the freedom to introduce design solutions that would be difficult to implement using traditional manufacturing techniques. Such is the case with compliant features embedded in amputee prosthetic sockets to relieve contact pressure at the residual limb-socket interface. The purpose of this study was to present a framework for designing compliant features to be incorporated into transtibial sockets and manufacturing prototypes using selective laser sintering (SLS) and Duraform material. The design process included identifying optimal compliant features using topology optimization algorithms and integrating these features within the geometry of the socket model. Using this process, a compliant feature consisting of spiral beams and a supporting external structure was identified. To assess its effectiveness in reducing residual limb-socket interface pressure, a case study was conducted using SLS manufactured prototypes to quantify the difference in interface pressure while a patient walked at his self-selected pace with one noncompliant and two different compliant sockets. The pressure measurements were performed using thin pressure transducers located at the distal tibia and fibula head. The measurements revealed that the socket with the greatest compliance reduced the average and peak pressure by 22% and 45% at the anterior side distal tibia, respectively, and 19% and 23% at the lateral side of the fibula head, respectively. These results indicate that the integration of compliant features within the socket structure is an effective way to reduce potentially harmful contact pressure and increase patient comfort.