Conduit cardiac-valve prosthesis and a method for the production thereof

• US 20030187500A1
• Filed: 02/28/2003
• Published: 10/02/2003
• Est. Priority Date: 10/09/2000
• Status: Abandoned Application

• Current Assignee: Adiam Life Science AG
• Original Assignee: Adiam Life Science AG
• Inventors: Haller, Oliver, Meess, Rudolf F J, Willeke, Sebastien, Classen, Christoph, Jansen, Josef
• Application Number:
  US10/363,477
• Publication Number:
  US 20030187500A1
• Time in Patent Office: Days
• US Class Current: 623/1.26
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: B29C 2791/001 Shaping in several steps
• CPC Class Codes: B29C 41/08 Coating a former, core or other substrate by spraying or fluidisation, e.g. spraying powder spray-up of reinforcing fibres B29C70/305
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 45/00 Injection moulding, i.e. forcing the required volume of moulding material through a nozzle into a closed mould; Apparatus therefor injection blow-moulding B29C49/06
• CPC Class Codes: B29C 69/02 of moulding techniques only
• CPC Class Codes: B29L 2031/7532 Artificial members, protheses
• CPC Class Codes: C08L 75/04 Polyurethanes

Abstract

The invention relates to a conduit cardiac-valve prosthesis. Said prosthesis consists of a cylindrical tube or a tube provided with bulbous projections with an integrated support housing comprising a base ring, which bears at least two stanchions that are orientated substantially in the direction of the ring axis and are connected by an arc-shaped wall that fixes flexible leaflets. The invention aims to improve the physiological properties of said prosthesis. To achieve this, the tube, the support housing and the leaflets consist of a single material, preferably polyurethane or another polymer and form a one-piece body.

Claims

1. A tubular valve prosthesis comprised of a cylindrical or bulb-shaped tube (1) with an integral support (2) consisting of a base ring (21) that carries at least two posts (22, 23, 24) extending parallel to the ring axis (3) and connected by arcuate walls carrying flexible cusps, characterized in that the tube (1), the support (2), and the cusps (3, 4, and 5) are made unitarily of a single material, preferably polyurethane or another polymer, and form a one-piece body.

2. The tubular valve prosthesis according to claim 1, characterized in that tube ends (1) connected to the support (2) are made of a microporous and elastic polyurethane having a greater elasticity than the support (2), the microporous material having pores that seen flat have a size from 20 μ

m to 80 μ

m.

3. The tubular valve prosthesis according to one of claims 1 or 2, characterized in that a reinforcement ring (6) preferably made of titanium or a titanium alloy is imbedded in the base ring (21).

4. A method of making a tubular valve prosthesis according to one of claim 1 to 3, wherein to make the cusps (3, 4, and 5) a male mold with surfaces corresponding to the shape of the cusps is repeatedly dipped in a polyurethane solution and the polyurethane film is dried between immersions and then the cusps (3, 4, and 5) are bonded with a tube (1), characterized in that after making the cusps (3, 4, and 5) the male mold is fitted to a female mold whose cavity is shaped like the support (2) and the support (2) is cast onto the cusps by injection molding, and thereafter tube ends (1) are either sprayed on both ends of the support or tube ends premade in another mold are adhered to the support, all materials being polyurethane

5. A method of making a tubular valve prosthesis according to one of claims 1 to 3, characterized in that to start with cusp-shaped surfaces (31) of a male mold (30) are coated by individual drops or a stream of a polymer solution or drops or a stream of a viscose polymerizing multicomponent system applied in points, in lines, in strips, in beads, or as a layer to the base body or a support tool, the layer is dried, and the application of drops or of the stream and the subsequent drying is repeated until the desired three-dimensionally shaped polymer body forms the cusp foils, that then the free cusp edges are separated, then a cusp-shaped surface of a female mold (32) is fitted over which forms the downstream part and if necessary also has bulb-shaped bulges (33), that a support (2) is then formed on the male mold (30) by dipping in a polymer solution or application of drops of a continuous stream, a metal ring (6) preferably of titanium or a titanium alloy is slipped over the lower part of this support (2) and it is subsequently imbedded with a polymer by dipping in the appropriate solution alternating with drying, and finally both molds (32 and 30) are sprayed to form the tube ends (1) or the tube ends are made separately and affixed by an adhesive.