Custom Silicone Distal Cup Designed and Fabricated Using 3D Optical Scanning and Additive Manufacturing to Improve Socket Fit of an Individual with Tranfemoral Amputation with Irregular Distal Residual Limb Morphology.

Introduction: The study presents the design and manufacturing of a custom silicone distal cup, with a high spatial resolution, to fit inside the prosthetic liner for the treatment of irregular morphology at the distal residual limb of a patient with lower-limb amputation. This distal cup for the inside of the prosthetic liner has intricate interior features matching the shape of the distal residual limb to prevent localized high-pressure regions. Methods: High-resolution 3D optical scanning, computer-aided design (CAD), and material extrusion (MEX) process for additive manufacturing of molds are three key techniques for designing and manufacturing this custom distal cup. A three-part mold for molding the distal cup with matching features was designed by CAD and fabricated by MEX. The subject evaluated the distal cup by walking using the distal cup before wearing the prosthetic liner in the lower-limb prosthesis. Results: A custom silicone distal cup was fabricated using a 3D-printed mold and evaluated using a Prosthetic User's Survey. Based on the survey, the insert has an acceptable comfort, suspension requirement, and ease of use. Conclusions: The scan by high spatial resolution Space Spider optical scanner could capture detailed features of the distal residual limb. The resulting distal cup had the protrusion that functioned to separate the invaginations. The subject was satisfied with the distal cup based on the Prosthetic User's Survey. Clinical Relevance: The approach to fabricate the custom silicone distal cup using a high-resolution 3D optical scanner and a 3D-printed mold can be applied to fabricate the distal cup with intricate features for a patient with irregular morphology at the distal residual limbs. [ABSTRACT FROM AUTHOR]