Design of a custom metamaterial insert for improved pressure distribution within transtibial prosthetic sockets.

Uneven pressure distribution within a transtibial prosthetic socket can lead to discomfort, skin degradation, and suspended prosthesis use. Current custom interfaces to improve pressure distribution are often costly, time-intensive to fabricate, or cannot be incorporated into standard socket fabrication methods. In this technical note, we describe the design and preliminary clinical evaluation of a novel transtibial prosthetic socket insert with modifiable mechanical properties, which can be incorporated into the current clinical cycle of care. The custom insert (termed "inlay") relies on a triangular unit cell, which can be modified based on the desired stiffness profile. Inserts are 3D printed in a soft polymer material and inset into shape-matched voids in a socket creating regions of custom offloading. Preliminary clinical efficacy of the inserts was assessed in a pilot long-term cross-over evaluation. After Institutional Review Board approval, 3 pilot participants wore a shape-matched replica of their habitual socket modified for insert use and a shape-matched socket without. Sockets were worn for 4-week each, and inner socket pressures were measured with thin film pressure sensors at the end of the wear period. Peak pressures within the distal tibial region of interest were decreased for 2 of 3 participants during midstance of level-ground walking when wearing the socket with inlays. The technical methods and results presented provide a new method to address high pressure regions within a transtibial prosthetic socket. The 3D-printed inlays can be rapidly produced allowing for easy modification and replacement without require new socket fabrication.