Prosthetic Heart Valve And Transcatheter Delivered Endoprosthesis Comprising A Prosthetic Heart Valve And A Stent

• US 20110295363A1
• Filed: 05/24/2011
• Published: 12/01/2011
• Est. Priority Date: 05/25/2010
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Lane, Randy, Girard, Michael J., Mayer, Arnulf
• Granted Patent: US 9,744,031 B2
• 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: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes

Abstract

The invention relates to a prosthetic heart valve (100) for an endoprosthesis (1) used in the treatment of a stenotic cardiac valve and/or a cardiac valve insufficiency. The prosthetic heart valve (100) comprises of a plurality of leaflets (102), which consist of a natural and/or synthetic material and have a first opened position for opening the heart chamber and a second closed position for closing the heart chamber, the leaflets (102) being able to switch between their first and second position in response to the blood flow through the heart. In addition, the prosthetic heart valve (100) comprises a leaflet support portion (103), consisting of biological and/or synthetic material for mounting of the prosthetic heart valve (100) to a stent (10), and a bendable transition area (104) which forms a junction between the leaflets (102) and the leaflet support portion (103), the transition area (104) progressing essentially in a U-shaped manner similar to a cusp shape of a natural aortic or pulmonary heart valve for reducing tissue stresses during opening and closing motion of the leaflets (102). The invention further relates to an endoprosthesis (1) comprising a prosthetic heart valve (100) and a stent (10)

Claims

1. A prosthetic heart valve for an endoprosthesis, the prosthetic heart valve comprising:

at least two, preferably three leaflets which comprise natural tissue and/or synthetic material and have a first opened position for opening the heart chamber and a second closed position for closing the heart chamber, the leaflets being able to switch between their first and second position in response to a blood flow through the heart;

a skirt portion comprising natural tissue and/or synthetic material for mounting of the prosthetic heart valve to a stent; and

a bendable transition area which forms a junction between the leaflets and the skirt portion, the bendable transition area progressing essentially in a U-shaped manner similar to the shape of a leaflet of a natural aortic or pulmonary heart valve for reducing tissue stresses during opening and closing motion of the leaflets.

2. The prosthetic heart valve according to claim 1, wherein the prosthetic heart valve is assembled as a one piece construction, said one piece construction being cut out of pericardial tissue, formed to build a flat tissue pattern and sewn into a cylindrical or conical shape.

3. The prosthetic heart valve according to claim 1, wherein the lower end section of the prosthetic heart valve exhibits a tapered or flared shape.

4. The prosthetic heart valve according to claim 1, wherein the leaflets have a cuspidal geometry which is formed in a elliptically, u-shaped or orbital manner.

5. The prosthetic heart valve according to claim 1, wherein the leaflets are designed to provide redundant coaptation for potential annular distortion.

6. The prosthetic heart valve according to claim 1, wherein the prosthetic heart valve comprises a plurality of fastening holes provided along the progression of the bendable transition area.

7. The prosthetic heart valve according to claim 6, wherein the fastening holes are introduced into the tissue material of the prosthetic heart valve by means of laser cutting, for strengthening tissue area around the fastening holes.

8. The prosthetic heart valve according to claim 1, wherein the bendable transition area includes a layering of various materials with differing mechanical properties, so as to provide high suture retention in lower parts of the bendable transition area, whereas the upper parts of the bendable transition area are designed to be flexible for improving the durability of the prosthetic heart valve.

9. The prosthetic heart valve according to claim 1, wherein the leaflets and the skirt portion exhibit a different stability through various cross-linking processes.

10. The prosthetic heart valve according to claim 1, wherein the prosthetic heart valve is designed for collapsing and delivering in a catheter.

11. The prosthetic heart valve according to claim 1, wherein the tissue material of the prosthetic heart valve is a xenograft made of bovine or porcine pericardial tissue.

12. The prosthetic heart valve according to claim 11, wherein the tissue material of the prosthetic heart valve has a thickness of 160 μ

m to 300 μ

m.

13. The prosthetic heart valve according to claim 1, wherein the prosthetic heart valve has a diameter ranging from 19 mm to 28 mm.

14. The prosthetic heart valve according to claim 1, wherein the prosthetic heart valve comprises three separate pieces (120) made of pericardial tissue, formed to build a flat tissue pattern.

15. The prosthetic heart valve according to claim 14, wherein each of the three separate pieces (120) has a flat tissue pattern in an essentially t-shirt like shape, exhibiting sleeves for connection between the three separate pieces, the three pieces being sewn into a cylindrical shape at contiguous edges.

16. An endoprosthesis used in the treatment of a stenosis of a cardiac valve and/or a cardiac valve insufficiency, the endoprosthesis comprising a prosthetic heart valve according to claim 1 and a stent to which the prosthetic heart valve is affixed.

17. The endoprosthesis according to claim 16, wherein the stent comprises a plurality of retaining arches and a plurality of commissure attachment regions designed for attachment to the bendable transition area of the prosthetic heart valve.

18. The endoprosthesis according to claim 17, wherein the plurality of retaining arches are provided with one or more fastening notches adapted to fix the bendable transition area of the prosthetic heart valve to the stent.

19. The endoprosthesis according to claim 16, wherein the stent comprises an annular collar arranged at a lower section of the stent, the annular collar being adapted to serve as an additional anchoring measure to hold the endoprosthesis in a desired location at the site of the diseased heart valve.

20. The endoprosthesis according to claim 16, wherein the prosthetic heart valve is stitched to the stent by means of a locking stitch or blanket stitch pattern, using braided multi-filament polyester sutures having a diameter between 0.1 mm to 0.2 mm.

21-50. -50. (canceled)