Abstract: 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.

Abstract: The invention relates to a method for preparing a polymer scaffold that comprises the steps of providing a piece of a fabric of filaments of a first biodegradable or biocompatible polymer, applying a coating of a second polymer to said arrangement of filaments, and stretching the piece along its axis of longitudinal extension, thereby obtaining an aligned microfibrillar scaffold. The invention further relates to a method for providing an artificial tissue, and to a microfibrillar scaffold of aligned filaments obtained by the method of the invention.

Abstract: 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.

Abstract: The invention relates to a method for preparing a polymer scaffold that comprises the steps of providing a piece of a fabric of filaments of a first biodegradable or biocompatible polymer, applying a coating of a second polymer to said arrangement of filaments, and stretching the piece along its axis of longitudinal extension, thereby obtaining an aligned microfibrillar scaffold. The invention further relates to a method for providing an artificial tissue, and to a microfibrillar scaffold of aligned filaments obtained by the method of the invention.

Abstract: The invention relates to a medical implant, comprising an expandable structure (100) which is designed to be expanded from a crimped state into an expanded state, wherein the structure (100) forms a tubular scaffolding in the expanded state, and wherein the structure (100) comprises a plurality of first struts (101) arranged along a periphery of the structure in said expanded state. According to the invention, the first struts (101) each comprise a recess (O), wherein the medical implant (1) further comprises a sealing member (200) arranged in said recesses (O), wherein said sealing member (200) is formed annularly in said expanded state.

Abstract: A biological heart valve replacement, particularly for pediatric patients, comprises a tubular segment (A) comprising a proximal end (Ep), a distal end (Ed) and a central portion (Pc) arranged between said proximal and distal ends and defining a longitudinal direction of the valve. The valve further comprises at least one inner leaflet (C) attached in hinge-like manner to a connection zone (F) at an inner wall (W) region of said central portion, each one of said inner leaflets being movable between a closing position and an opening position of the valve. In order to provide growth adaptability, the tubular segment comprises at least one tubular growth zone (B; B1,B2) configured as a longitudinal strip made of a growth-adaptive biomaterial, with the remainder of the tubular segment being made of a non-growth-adaptive biomaterial.

Abstract: Various inserts, called shapers and spacers, are provided for controlling tissue engineered heart valve (TEHV) leaflet geometry during culture. These inserts will prevent TEHV leaflet retraction during culture, be able to control the leaflet geometry during culture, enable culturing TEHV leaflets with a larger coaptation area, control the height of the coaptation area, maintain TEHV leaflet curvatures, and/or enable possibilities to culture TEHV leaflets in open configuration.

Abstract: The invention relates to a medical implant, comprising an expandable structure (100) which is designed to be expanded from a crimped state into an expanded state, wherein the structure (100) forms a tubular scaffolding in the expanded state, and wherein the structure (100) comprises a plurality of first struts (101) arranged along a periphery of the structure in said expanded state. According to the invention, the first struts (101) each comprise a recess (O), wherein the medical implant (1) further comprises a sealing member (200) arranged in said recesses (O), wherein said sealing member (200) is formed annularly in said expanded state.

Abstract: Various inserts, called shapers and spacers, are provided for controlling tissue engineered heart valve (TEHV) leaflet geometry during culture. These inserts will prevent TEHV leaflet retraction during culture, be able to control the leaflet geometry during culture, enable culturing TEHV leaflets with a larger coaptation area, control the height of the coaptation area, maintain TEHV leaflet curvatures, and/or enable possibilities to culture TEHV leaflets in open configuration.

Abstract: A biological heart valve replacement, particularly for pediatric patients, comprises a tubular segment (A) comprising a proximal end (Ep), a distal end (Ed) and a central portion (Pc) arranged between said proximal and distal ends and defining a longitudinal direction of the valve. The valve further comprises at least one inner leaflet (C) attached in hinge-like manner to a connection zone (F) at an inner wall (W) region of said central portion, each one of said inner leaflets being movable between a closing position and an opening position of the valve. In order to provide growth adaptability, the tubular segment comprises at least one tubular growth zone (B; B1,B2) configured as a longitudinal strip made of a growth-adaptive biomaterial, with the remainder of the tubular segment being made of a non-growth-adaptive biomaterial.

Abstract: The invention relates to a tubular supporting prosthesis capable of growing, comprising a mesh structure, wherein the mesh structure comprises at least two structural rings, which are connected to each other via connecting members and are disposed point-symmetrically about the longitudinal supporting prosthesis axis, wherein the structural rings and/or the connecting members have at least one predetermined breaking point.

Abstract: The invention relates to a tubular supporting prosthesis, comprising two terminal regions relative to the longitudinal supporting prosthesis axis and a center region disposed between the two terminal regions, wherein every terminal region is provided with a mesh structure made of at least two structural rings, which are connected to each other via connecting members and are disposed point-symmetrically about the longitudinal supporting prosthesis axis. The center region is formed by elongated connecting members, which are connected to the structural rings respectively disposed adjacent to the center of the longitudinal supporting prosthesis axis. An aortic valve, which is produced by means of tissue engineering, is fastened and/or integrated in the center region.

Abstract: The invention relates to a tubular supporting prosthesis capable of growing, comprising a mesh structure, wherein the mesh structure comprises at least two structural rings, which are connected to each other via connecting members and are disposed point-symmetrically about the longitudinal supporting prosthesis axis, wherein the structural rings and/or the connecting members have at least one predetermined breaking point.

Abstract: The invention relates to a tubular supporting prosthesis, comprising two terminal regions relative to the longitudinal supporting prosthesis axis and a center region disposed between the two terminal regions, wherein every terminal region is provided with a mesh structure made of at least two structural rings, which are connected to each other via connecting members and are disposed point-symmetrically about the longitudinal supporting prosthesis axis. The center region is formed by elongated connecting members, which are connected to the structural rings respectively disposed adjacent to the center of the longitudinal supporting prosthesis axis. An aortic valve, which is produced by means of tissue engineering, is fastened and/or integrated in the center region.