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, said cushioning structure is a beam, defined around a centerline of any arbitrary shape. In another preferred embodiment, said cushioning structure has the shape of a spiral.

A mechanical interface connecting a biological body segment, such as a limb, portion of a limb or other body segment, to a wearable device such as a prosthetic, orthotic or exoskeletal device, is fabricated by quantitatively mapping a characterized representation of the body segment to form a digital representation of the mechanical interface shape and mechanical interface impedance. The mechanical interface includes a continuous socket defining a contoured inside surface and a contoured outside surface, and includes a material having an intrinsic impedance that varies through the material, so that the intrinsic impedance varies along the contoured inside surface.

A transtibial prosthetic device comprises a pylon configured as a unitary truss structure formed of a plurality of elongated supports interconnected at nodes and having open spaces between supports of the plurality of elongated supports. The unitary truss structure comprises a polymer. A foot-ankle complex extends from a base of the pylon. The foot-ankle complex comprises an s-shaped posterior portion, an s-shaped anterior portion, and a sole portion. The s-shaped posterior portion and the s-shaped anterior portion both extend from the sole portion, have upper portions with curvatures that are concentric with each other, and are separated from each other by a gap.

A prosthesis system (10) adapted for being worn by a user (1) comprises at least a first cover (11), a prosthetic limb (12) and an adapter device (13, 14) for fixing the first cover to the prosthetic limb, wherein the adapter device comprises a first adapter part (13) configured for being attached to the first cover, a second adapter part (14) configured for being mounted onto the prosthetic limb and locking means (131, 141) for locking the cover (11) onto the prosthetic limb.

The present invention provides a method of manufacturing a customized breast prosthesis in such a manner as to perform three-dimensional scanning of user's body and apply the same shape, the same volume, and the same density as the actual breast to have the same weight, a system for manufacturing the same, a computer program and computer-readable record medium for the same, a customized breast prosthesis manufacture by the above method, and a customized correction brassiere for accommodating the customized breast prosthesis.

A prosthetic appendage for attachment to an outer extremity of an amputated limb that is composed of modular elements fabricated by three-dimensional printing. In one embodiment the prosthetic appendage is a leg. The prosthetic leg includes a foot portion and a plurality of modular and three-dimensionally printed limb elements. One of the plurality of limb elements is pivotally coupled to the foot portion and another of the limb elements is configured at one end to receive the outer extremity of the amputated leg. In another embodiment of the present invention the prosthetic appendage is a hand. The prosthetic hand includes a wrist element with one end configured to receive the outer extremity of an amputated hand, a base portion attached to the wrist element and a plurality of modular and three-dimensionally printed finger elements selectively coupled to adjacent finger elements or the base to form prosthetic fingers.

The invention is a method of designing and manufacturing a 3D printed prosthetic socket or a standard prosthetic socket with a 3D printed distal end, comprising a step of obtaining physical data about a patient with a residual limb and a step of creating a structural design of the 3D printed prosthetic socket or standard prosthetic socket with the 3D printed distal end. The step of creating the structural design of the 3D printed prosthetic socket (3) or standard prosthetic socket with the 3D printed distal end comprises a step of determining the bulk density of the structure of the prosthetic socket between a shaped area for positioning a linking part of the liner and a distal planar area for mounting a linking adapter of the socket directly proportional to at least one of the data from a set including at least weight, patient's degree of activity, length of the residual limb, length of the prosthesis, size of the prosthetic foot, and angle between the axis of the limb and the axis of the prosthesis.

Mould assembly for injection moulding a personalised hollow breast prosthesis, wherein the mould assembly comprises: a front mould being a female mould of a front side of a patients breast and comprising a first mould surface, a rear mould being a female mould of a patients mastectomized chest and comprising a second mould surface, a mould core comprising a mould core main body being a scaled positive mould of a combination of the patients breast and the patients mastectomized chest, wherein the mould core is smaller than the combination, a support configured to support the mould core main body in an assembled state of the mould assembly, wherein an injection opening is defined by any of the front mould, the rear mould, and the mould core, and wherein in the assembled state the mould core is located between the front mould and the rear mould in order for a mould core surface to be located at a distance from the first mould surface and the second mould surface, wherein in the assembled state an inner volume is defined by the front mould, the rear mould and mould core and is configured to be filled with an injection moulding material.

A method and associated system for designing a biomechanical interface of a device contacting a biological body segment of a subject includes forming a quantitative model of the biological body segment from subject specific data, conducting a biophysical analysis, such as a finite element analysis, to thereby establish a relationship, such as a functional relationship, between the quantitative model and at least one feature of the biomechanical interface contacting the biological body segment, and applying the relationship to the at least one feature of the biomechanical interface contacting the biological body segment to thereby obtain an interface design for the mechanical interface of the device. The subject-specific data can include geometry of the biological body segment and the at least one feature can be associated with physiological benefit of the biological body segment.

A method for producing a prosthesis socket in which a 3D-dataset is produced of an outer contour of a stump on which a prosthesis socket is to be mounted, and a base socket is produced from a first material in a 3D printing method using said 3D dataset, wherein an inner contour of the base socket corresponds to the outer contour of the stump, and at least one stabilising element consisting of a second material is laminated onto the base socket.