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. (
Background:3D-printing is a potential manufacturing process for optimizing the design and manufacture of ankle foot orthosis (AFOs). The feasibility of an AFO with interchangeable strut that is suitable for 3D-printing is created and evaluated.Objective:A segmented AFO with 3D-printed custom footplate and calf shell connected by a custom-made strut is studied.Study design:The duration of a healthy subject wearing the 3D-printed segmented AFO in daily activities is used to evaluate the feasibility and durability to integrate 3D-printed AFOs into orthotics practice.Technique:The 3D-scanning of a patient's leg is first conducted. The scanned 3D surface is modified by creating the clearance around bony prominences and trimlines for the footplate and calf shell. The footplate has a custom-shaped inside to match with the foot and a standard shape outside at the top to match and connect with the strut. For the calf shell, the inside shape is custom fit with the shank and the outside shape is standard to connect with the strut. Material extrusion is the 3D-printing process selected. Tree-like support structures are used to avoid the use of soluble support material and to eliminate the risk of residual chemical solvent in the orthosis.Results:The segmented AFO with material extrusion footplate and calf shell was tested in a healthy subject with an active lifestyle, offering comfort, and stability for over 4 months without breakage.Conclusions:This segmented AFO is durable, requires short 3D-printing time, and enables the quick adjustment of bending stiffness via an interchangeable strut design.
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