A method of manufacturing a custom device for external application to the head of a patient over a removed portion of the cranium of the patient is described. A three dimensional digital image portion of the external surface of the head comprising at least the removed portion is generated. A three dimensional digital image portion is processed to identify the removed portion. A digital file is generated that is utilized to manufacture the device.

Systems and methods for creating custom-fit prosthetic devices, orthotic devices, and related medical devices via three-dimensional printing (3D printing) or additive manufacturing techniques are described. Through the described systems and methods, a residual limb or other body part of a patient is scanned and analyzed to determine measurements and characteristics of the residual limb. The measurements and characteristics of the residual limb are used to design a customized device for the residual limb. The customized device uses multiple different materials. For example, the customized device may use a first material for a frame and a second material for a liner, wherein the first material is more rigid than the second material. The customized device is fabricated using a three-dimensional printer that is capable of printing and bonding multiple different materials at the same time.

A compression stabilized prosthetic device for a patient having an amputated limb includes a first socket portion for contacting a patient's limb, and a second portion for the attachment of a prosthetic component. The first socket portion has compression portions configured for compressing portions of the patient's limb, and relief portions for receiving other portions of the patient's limb which bulge upon the compression applied by the compression portions. The relief portions may be formed as openings or as enlarged radius portions of the first socket portion.

The invention relates to a computer-implemented method for producing an orthopedic device. The method includes receiving at least one data set with patient data, processing the patient data in order to create a patient model, using the patient model to determine patient parameters, and generating a virtual representation of the orthopedic device while using the patient parameters and device parameters. The method further includes receiving at least one input from at least one user, modifying at least one of the patient parameters or device parameters on the basis of the input, and physically creating the orthopedic device.

A compliant prosthetic foot is designed and fabricated by combining a compliant mechanism optimization technique with a calculation of low leg trajectory error under a reference loading condition. The compliant mechanism optimization technique includes a set of determinants for the compliant prosthetic foot. An optimized set of determinants of the compliant prosthetic foot is formed that minimizes the lower leg trajectory error relative to a target kinematic data set. The compliant prosthetic foot is then fabricated in conformance with the optimized set of determinants.

A method of manufacturing a custom device for external application to the head of a patient over a removed portion of the cranium of the patient is described. A three dimensional digital image portion of the external surface of the head comprising at least the removed portion is generated. A three dimensional digital image portion is processed to identify the removed portion. A digital file is generated that is utilized to manufacture the device.

A two-part prosthetic socket which includes an inner socket component having an inner profile substantially complementary to a profile of a residual limb of a patient, and an outer socket component configured to releasably attach about an outer surface of the inner socket component is disclosed. The inner profile of the inner socket component may be determined from digital data output from a medical imaging scan of the residual limb, which provides a three-dimensional digital profile of the residual limb that includes information on the size and location of at least bone and bone spurs, muscle, scar tissue, and neuroma. The digital data may further include a designed operating range for the size and shape of the three-dimensional digital profile of the residual limb based on such information. The two-part prosthetic socket may be manufactured using additive manufacturing, wherein the inner socket may be formed of a flexible material and the outer socket may be formed of a rigid material.

Orthotic and prosthetic devices having integrated features such as cushioning features are described, as well as methods for computer aided designing and making of these devices. The orthotic or prosthetic devices comprise a cushioning layer superimposed onto an orthotic or prosthetic shell, the cushioning layer comprising an array (35) of discrete solid and resilient cushioning elements (31). In one preferred embodiment, the cushioning structure is a beam, defined around a centerline of any arbitrary shape. In another preferred embodiment, the cushioning structure has the shape of a spiral.

A prosthetic limb and process to digitally construct a prosthetic limb which includes first, digitally producing a modified mold of a residual limb via 3d scanners and software known to the industry; constructing a test socket from the digitally modified mold and be equipped with an alignable system; for example, a pylon, along with the desired prosthetic foot; accurately scanning the test socket, preferably with a 3D scanner, along with finalized alignment that has been recorded and adjusted by a certified practitioner to provide a 3-D Image of the finalized prosthetic alignment; transferring the finalized digital alignment of the test socket to the finalized digitally modified mold; once the modified model has received the transferred alignment, fabricating the type of hookup in the socket; i.e., plug fit, four hole, support drop lock, or any other type of industry standard connection or accommodation via basic 3D software; and once the desired prosthetic attachment is finalized, the next step is to send the finished file to a 3-D printer to produce the definitive prosthetic device. The 3-D printed socket would then be placed in a vibratory finishing system to smooth out the interior and exterior surfaces of the printed socket; and the walls of the 3-D printed socket would be sealed by applying a mixture of epoxy sealant, for example, TC-1614, to the inside and outside walls of the socket, and placing the socket into an oven for a sufficient amount of time to seal the walls of the socket. Preferably, the prosthesis would be printed out of Nylon 12 material or of a strong plastic, such as ULTEM, or carbon fiber, or other material of equivalent or greater strength that may be known or developed in the future.

A method of manufacturing a custom device for external application to the head of a patient over a removed portion of the cranium of the patient is described. A three dimensional digital image portion of the external surface of the head comprising at least the removed portion is generated. A three dimensional digital image portion is processed to identify the removed portion. A digital file is generated that is utilized to manufacture the device.