The invention relates to a device for producing a spacer having a stem mold (1) which has an inner space (2), wherein the inner space (2) is accessible via a proximal opening (3) and wherein the stem mold (1) has a proximal wall (4) which peripherally delimits the proximal opening (3) of the stem mold (1), a head mold (5) which has in the interior thereof a hollow space (6), wherein the hollow space (6) has a spherical surface-shaped inner surface (7) and is accessible via a distal opening (8), wherein the head mold (5) has a distal wall (9) which peripherally delimits the distal opening (8) of the head mold (5), a metal core (10) which has a stem part (12), a head part (14) and a flange (16), wherein the flange (16) projects out from the metal core (10), is arranged between the stem part (12) and the head part (14) and has a proximal surface (18) and a distal surface (20), wherein the stem mold (1) and the stem part (12) are shaped such that the stem part (12) is arranged in the inner space (2), when the proximal wall (4) is resting against the distal surface (20), and wherein the head mold (5) and the head part (14) are shaped such that the head part (14) is arranged in the hollow space (6), when the distal wall (9) is resting against the proximal surface (18).

The invention also relates to a set with such a device and to a method for producing spacers with such a device.

A personalized prosthesis for implantation at a treatment site of a patient includes a self-expanding mesh or membrane having collapsed and expanded configurations. The collapsed configuration is adapted to be delivered to the treatment site, and the expanded configuration engages the personalized prosthesis with the treatment site. The mesh or membrane is personalized to match the treatment site in the expanded configuration, and has an outer surface that substantially matches the treatment site shape and size. The self-expanding mesh or membrane forms a central lumen configured to allow blood or other body fluids to flow therethrough. Methods of manufacturing and delivery of the personalized prosthesis are also disclosed.

Methods and materials for making complex, living, vascularized tissues for organ and tissue replacement, especially complex and/or thick, structures, such as liver tissue is provided. Tissue lamina is made in a system comprising an apparatus having (a) a first mold or polymer scaffold, a semi-permeable membrane, and a second mold or polymer scaffold, wherein the semi-permeable membrane is disposed between the first and second molds or polymer scaffolds, wherein the first and second molds or polymer scaffolds have means defining microchannels positioned toward the semi-permeable membrane, wherein the first and second molds or polymer scaffolds are fastened together; and (b) animal cells. Methods for producing complex, three-dimensional tissues or organs from tissue lamina are also provided.

A method includes mixing a polymer, an organic solvent, and a porogen such that an initial paste is formed. The method also includes in-situ shaping the initial paste; creating a plurality of channels within the shaped paste and removing the organic solvent from the shaped paste such that a solidified perforated paste is formed; and leaching out the porogen from the solidified perforated paste such that a porous scaffold is formed.

A personalized prosthetic valve for implantation at a native valve treatment site includes a self-expanding mesh and a plurality of valve leaflets coupled to the mesh. The mesh may be delivered to the native valve in a collapsed configuration, and in an expanded configuration the mesh engages the native valve. The mesh in the expanded configuration is also personalized to match the treatment site, such that the outer mesh surface substantially matches the treatment site shape and size. The self-expanding mesh forms a central lumen configured to allow blood or other body fluids to pass therethrough. In the open configuration, blood passes through the prosthetic valve, and in the closed configuration, the plurality of leaflets are closer together and blood is prevented from flowing upstream through the prosthetic valve.

The application provides molds for the manufacture of intraluminal endoprostheses and methods for their manufacture. In particular embodiments, the methods comprise the steps of providing a 3D model of the mold, meshing the model, manufacturing a mold based on said meshed 3D model. Also provided herein are methods for manufacturing an endoprosthesis using said mold.

An earplug device that is placed in the ear canal to attenuate sound frequencies within a selected frequency range. The earplug has a plug body with a first end, an opposite second end, and an exterior surface that extends from the first end to the second end. An opening is formed in the plug body at the first end. The opening leads to an internal conduit within the plug body. The internal conduit terminates at a closed membrane wall proximate the second end of the plug body. The internal conduit and the membrane wall both act upon incoming acoustic signals to both lower volume and attenuate certain undesired frequency ranges.

Methods and apparatus are provided for forming a patient-specific surgical implant based on mold system. The apparatus comprises a forming tool and a mold that may be generated using imaging and processing techniques and rapid prototyping methods. The mold apparatus includes at least two non-adjacent surface features for securing an implant forming material (such as a titanium mesh) during the forming process, enabling the implant forming material to be stretched beyond its elastic and thus permanently deformed with the correct patient-specific curvature. The implant may include one or more anatomic surface features for guidance and registration when transferring the implant to a patient.

The specification relates to a method of manufacturing a diabetic foot patient-specific skin regeneration sheet, and a diabetic foot patient-specific skin regeneration sheet.

Systems and methods for the manufacture of an hourglass shaped stent-graft assembly comprising an hourglass shaped stent, graft layers, and an assembly mandrel having an hourglass shaped mandrel portion. Hourglass shaped stent may have superelastic and self-expanding properties. Hourglass shaped stent may be encapsulated using hourglass shaped mandrel assembly coupled to a dilatation mandrel used for depositing graft layers upon hourglass shaped mandrel assembly. Hourglass shaped mandrel assembly may have removably coupled conical portions. The stent-graft assembly may be compressed and heated to form a monolithic layer of biocompatible material. Encapsulated hourglass shaped stents may be used to treat subjects suffering from heart failure by implanting the encapsulated stent securely in the atrial septum to allow blood flow from the left atrium to the right atrium when blood pressure in the left atrium exceeds that on the right atrium. The encapsulated stents may also be used to treat pulmonary hypertension.