Prosthetic heart valve and endoprosthesis comprising a prosthetic heart valve and a stent

• US 10,603,164 B2
• Filed: 07/25/2017
• Issued: 03/31/2020
• Est. Priority Date: 05/25/2010
• Status: Active Grant

• Current Assignee: JenaValve Technology, Inc.
• Original Assignee: JenaValve Technology, Inc.
• Inventors: Girard, Michael J., Lane, Randy, Mayer, Arnulf
• Primary Examiner(s): Prebilic, Paul B
• Application Number:
  US15/658,955
• Publication Number:
  US 20180008405A1
• Time in Patent Office: 980 Days
• 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 assembly comprising:

at least two pieces of tissue comprising;

a distal portion including a leaflet between a first sleeve and a second sleeve; and

a proximal portion having a width less than a width of the distal portion; and

at least two reinforcement elements;

wherein the first sleeve of each piece is coupled to the second sleeve of an adjacent piece to form a commissure of the prosthetic heart valve assembly, and an outer surface of each commissure is covered by one of the reinforcement elements; and

wherein the proximal portion of each piece includes (1) a first side edge extending from the first sleeve to a proximal zigzag edge and (2) a second side edge extending from the second sleeve to the proximal zigzag edge, and wherein the first side edge of each piece is sutured to the second side edge of an adjacent piece.

2. The prosthetic heart valve assembly of claim 1, wherein each piece of tissue is a monolithic piece of natural tissue or synthetic tissue.

3. The prosthetic heart valve assembly of claim 1, wherein each reinforcement element of the at least two reinforcement elements is flexible and comprises a polymer.

4. The prosthetic heart valve assembly of claim 1, wherein each reinforcement element of the at least two reinforcement elements is made of polytetrafluoroethylene or polyethylene terephthalate.

5. The prosthetic heart valve assembly of claim 1, wherein each piece of tissue is a monolithic piece of pericardial tissue that includes the distal portion and the proximal portion and has a thickness ranging from 160 μ

m to 300 μ

m.

6. The prosthetic heart valve assembly of claim 1, wherein, for each commissure, end portions of the first sleeve and the second sleeve are folded away from each other.

7. The prosthetic heart valve assembly of claim 1, wherein, for each commissure, end portions of the first sleeve and the second sleeve are sutured to a perimeter of the reinforcement element.

8. The prosthetic heart valve assembly of claim 1, wherein the at least two pieces are cut from a single sheet of pericardial tissue.

9. The prosthetic heart valve assembly of claim 1, wherein the at least two pieces are cut from different sheets of pericardial tissue.

10. The prosthetic heart valve assembly of claim 1, wherein the prosthetic heart valve assembly is attached to an inner surface of an expandable stent, the at least two reinforcement elements being sutured to respective commissure posts of the stent.

11. The prosthetic heart valve assembly of claim 10, wherein each commissure post includes two holes distributed along a longitudinal axis of the commissure post.

12. The prosthetic heart valve assembly of claim 10, wherein a distal end of each commissure post includes a rounded element for attachment to a catheter, each reinforcement element being sutured to a respective commissure post at a location proximal to the rounded element.