The present invention concerns a tissue-engineered medical device, as well as a method for the production said medical device, comprising the following steps: providing a polymer scaffold comprising a mesh comprising polyglycolic acid, and a coating comprising poly-4-hydroxybutyrate; application of a cell suspension containing preferably human cells to the polymer scaffold; placement of the seeded polymer scaffold in a bioreactor and mechanical stimulation by exposure to a pulsatile flux of incremental intensity, thereby forming an extracellular matrix; mounting of the graft on a conduit stabilizer and incubation in cell culture medium; decellularisation of the graft in a washing solution; nuclease treatment of the graft; and rinsing of graft. The invention further comprises and various steps of quality control of the tissue-engineered medical device.

An implantable device for penile construction includes a tissue ingrowth cover. The tissue ingrowth cover may be disposed between a penile prosthesis and an interior wall of a neophallus, when the penile prosthesis is implanted within the neophallus.

An ocular covering fabricated from at least one amniotic membrane, at least one chorionic membrane, or at least one amniotic membrane and at least one chorionic membrane obtained from human birth tissue is provided. Methods of preparing the one or more membranes to form an ocular covering are provided. Methods of treating a disease, condition, or surgical site of the eye and surrounding tissue are also provided.

An intraocular implant, such as a corneal implant, an intraocular lens or an IOL carrier matrix, which has a dimensionally stable lattice structure and a corresponding method for producing an intraocular implant. The intraocular implant and method for producing an intraocular implant counteract metabolic problems, and thus also limited functional compatibility, and facilitates long-term tolerance. The intraocular implant has a dimensionally stable lattice structure designed in such a way that it permits permeability for small molecules and/or supports the mobility of endogenous cells in the implant.

The present disclosure relates to surgical grafts for replacing nipples and areolas lost to disease or trauma with surgical grafts of decellularized donor nipples and areolas and to placing and recellularizing such grafts. The disclosure further provides methods for decellularizing epidermis. The decellularized epidermis can be used as a protective cover for skin wounds.

A method of preparing a reconstitutable implantable bone putty includes combining a bone matrix derived from human bone and gelatin particulates derived from human tissue at a concentration of the bone matrix by dry weight of 20 to 60 percent to form the reconstitutable implantable bone putty. Preparing the gelatin particulates includes supplying a gelatin precursor of bone or soft tissue from a human, treating the gelatin precursor with phosphoric acid to generate a gelatin-acid mixture, neutralizing the gelatin-acid mixture with an alkali to a pH between 6 and 8 to allow a gelatin-rich solution and a waste solution to separate, removing residual salts from the gelatin-rich solution to obtain purified gelatin, drying the purified gelatin, and reducing the purified gelatin to particulates having a largest dimension less than 300 m. A method of preparing an implantable bone putty includes adding a reconstitution media to the reconstitutable implantable bone putty.

A method of corneal implantation with cross-linking is disclosed herein. In one or more embodiments, the method includes the steps of: (i) forming a flap in a cornea of an eye so as to expose a stromal tissue of the cornea underlying the flap; (ii) pivoting the flap so as to expose the stromal tissue of the cornea underlying the flap; (iii) inserting an implant under the flap so as to overlie the stromal tissue of the cornea; (iv) applying laser energy and/or microwaves to the implant in the eye so as to modify the refractive power of the implant; (v) applying a cross-linking solution that includes a photosensitizer to the implant; (vi) covering the implant with the flap; and (vii) irradiating the implant so as to activate cross-linkers in the implant, and thereby cross-link the implant and the stromal tissue of the cornea surrounding the implant.

An optical method for determining collagen bundle orientation in bovine pericardium includes the use of a system having a light source which transmits light through a first polarizer, a tissue for making a prosthetic valve leaflet, and a second polarizer, where the light then illuminates a detector plate. The light that illuminates the detector plate is used to determine the orientation of collagen fiber bundles. The orientation of the collagen fiber bundles is used to determine where to cut the leaflet edges.

A system for preparation of an implant and ab interno insertion of the implant into an eye including a handle having one or more actuators and an elongated shaft having an outer sheath and an elongate member positioned within a lumen of the tubular outer sheath. The system includes a recess sized for holding a patch of material fixed relative to the handle and a cutting member movable relative to the handle and to the recess. The cutting member cuts the patch of material into an implant as the cutting member moves towards a cutting configuration. The implant, once cut, is axially aligned with the lumen of the tubular outer sheath. The inner elongate member is movable relative to the tubular outer sheath to advance the implant into a deployment position in the lumen of the tubular outer sheath for delivery into the eye. Related devices and methods are provided.

A system for preparation of an implant and ab interno insertion of the implant into an eye including a handle having one or more actuators and an elongated shaft having an outer sheath and an elongate member positioned within a lumen of the tubular outer sheath. The system includes a recess sized for holding a patch of material fixed relative to the handle and a cutting member movable relative to the handle and to the recess. The cutting member cuts the patch of material into an implant as the cutting member moves towards a cutting configuration. The implant, once cut, is axially aligned with the lumen of the tubular outer sheath. The inner elongate member is movable relative to the tubular outer sheath to advance the implant into a deployment position in the lumen of the tubular outer sheath for delivery into the eye. Related devices and methods are provided.