Unibody endoskeletal transtibial prosthetic devices and digital fabrication workflow

Abstract

A unibody transtibial prosthetic device includes a socket personalized for a specific patient’s residual limb. A pylon extends from the socket, the pylon being a unitary polymer structure of interconnected elongated supports having open spaces therebetween. The device also includes a foot-ankle complex, the foot-ankle complex being a unitary polymer extending from the pylon, the foot and ankle unitary structure being shaped to provide multi-axial dynamic flex to enable dorsiflexion, plantar flexion, inversion and eversion motion for smooth symmetric gait performance and energy capture and return. The socket, pylon and foot-ankle complex are portions of a unibody.

1 . A unibody transtibial prosthetic device, comprising:
 a socket configured to attach to a residual limb;   a pylon extending from the socket, the pylon being a unitary polymer structure of interconnected elongated supports having open spaces therebetween; and   a foot-ankle complex, the foot-ankle complex being a unitary polymer extending from the pylon, the foot and ankle unitary structure being shaped to provide multi-axial dynamic flex.   
     
     
         2 . The unibody transtibial prosthetic device of  claim 1 , wherein the socket, pylon and foot-ankle complex are a unitary single piece. 
     
     
         3 . The unibody transtibial prosthetic device of  claim 1 , wherein the unitary single piece comprises a single polymer. 
     
     
         4 . The unibody transtibial prosthetic device of  claim 1 , wherein the unitary single piece comprises multiple materials with different stiffnesses. 
     
     
         5 . The unibody transtibial prosthetic device of  claim 1 , wherein the pylon is shaped and dimensioned to be within extended external boundaries of the residual limb. 
     
     
         6 . The unibody transtibial prosthetic device of  claim 1 , wherein the interconnected elongated supports define a central open cavity and curve around the open cavity. 
     
     
         7 . The unibody transtibial prosthetic device of  claim 6 , wherein the interconnected elongated supports and open spaces therebetween model a mirrored boundary of a contralateral transtibial leg portion of a patient. 
     
     
         8 . The unibody transtibial prosthetic device of  claim 6 , wherein the central open cavity has a decreasing diameter from the socket to the foot-ankle complex. 
     
     
         9 . The unibody transtibial prosthetic device of  claim 1 , wherein the interconnected elongated supports and open spaces define an endoskeleton shape complementary model of a contralateral transtibial leg portion of a patient. 
     
     
         10 . The unibody transtibial prosthetic device of  claim 1 , wherein the pylon is formed of thermoplastic. 
     
     
         11 . The unibody transtibial prosthetic device of  claim 1 , wherein the foot-ankle complex comprises a split ankle structure. 
     
     
         12 . The unibody transtibial prosthetic device of  claim 11 , wherein the split ankle structure comprises an s-shaped posterior portion and s-shaped anterior portion separated from each other by a gap extending from terminal portion of the s-shaped anterior portion to a sole portion. 
     
     
         13 . The unibody transtibial prosthetic device of  claim 12 , wherein the s-shaped posterior portion is solid and thicker than the s-shaped anterior portion. 
     
     
         14 . The unibody transtibial prosthetic device of  claim 13 , wherein an upper portion of the s-shaped posterior portion is unitary with lowest portion of the pylon. 
     
     
         15 . The unibody transtibial prosthetic device of  claim 13 , wherein the s-shaped anterior portion comprises one or more pass-through openings. 
     
     
         16 . The unibody transtibial prosthetic device of  claim 11 , wherein the sole portion comprises a split toe and a split heel. 
     
     
         17 . The unibody transtibial prosthetic device of  claim 1 , wherein the foot-ankle complex comprises a central strip of stiffer material surrounded by more flexible material. 
     
     
         18 . The unibody transtibial prosthetic device of  claim 1 , wherein an outer surface of the entire transtibial prosthetic device is flexible material and includes a core of stiffer material. 
     
     
         19 . A patient specific workflow method for producing a unibody transtibial prosthetic device, the workflow comprising:
 acquiring patient data via imaging and/or scanning;   constructing a 3D model from the patient data;   translating the 3D model to 3D printable design of a unibody transtibial prosthesis;   3D printing the unibody transtibial prosthesis.   
     
     
         20 . The method of  claim 19 , wherein the acquiring patient data comprises imaging a contralateral limb and residual limb..