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

Patent metadata

Field	Value
Publication number	US-12447015-B2
Application number	US-202318175319-A
Country	US
Kind code	B2
Filing date	Feb 27, 2023
Priority date	May 25, 2010
Publication date	Oct 21, 2025
Grant date	Oct 21, 2025

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 ).

First claim

The invention claimed is:

1. A prosthetic heart valve comprising:
a stent comprising a plurality of cells, a plurality of retaining arches comprising a plurality of bending edges and defining an outflow edge of the plurality of cells, and a plurality of commissure attachment regions;
at least two leaflets comprising natural tissue and/or synthetic material and having a first opened position for opening the heart chamber and a second closed position for closing the heart chamber, the leaflets configured to switch between the first opened position and the second closed position in response to a blood flow through the heart, the at least two leaflets each coupled to one or more commissure attachment regions of the plurality of commissure attachment regions at one end of each leaflet of the at least two leaflets and each leaflet coupled to a respective retaining arch of the plurality of retaining arches by one or more sutures secured to the plurality of retaining arches by the bending edges;
a skirt portion comprising natural tissue and/or synthetic material, the skirt portion coupled to the plurality of cells and the plurality of retaining arches; and
a bendable transition area formed at the plurality of retaining arches and defining a junction between at least one of the at least two leaflets and the skirt portion, the bendable transition area progressing essentially in a U-shaped manner and configured to reduce tissue stresses during opening and closing motion of the at least two leaflets.

2. The prosthetic heart valve of claim 1 , wherein the skirt portion is integral with the at least one of the at least two leaflets.

3. The prosthetic heart valve of claim 1 , wherein the stent further comprises a plurality of positioning arches configured to be inserted into cusps of native leaflets of a native valve.

4. The prosthetic heart valve of claim 3 , wherein a native leaflet is positioned between each positioning arch of the plurality of positioning arches and each retaining arch of the plurality of retaining arches when plurality of positioning arches are inserted into the cusps of the native valve.

5. The prosthetic heart valve of claim 3 , wherein each positioning arch of the plurality of positioning arches is circumferentially aligned with each retaining arch of the plurality of retaining arches.

6. The prosthetic heart valve of claim 1 , wherein the bending edges of the plurality of retaining arches form fastening notches configured to receive the one or more sutures.

7. The prosthetic heart valve of claim 1 , wherein the bending edges divide each retaining arch of the plurality of retaining arches into a plurality of arm segments.

8. The prosthetic heart valve of claim 1 , wherein the commissure attachment region is positioned at an outflow region of the stent.

9. The prosthetic heart valve of claim 1 , wherein the skirt portion and at least a portion of the plurality of cells are configured to form a seal against an inner wall of a blood vessel.

10. The prosthetic heart valve of claim 1 , wherein each leaflet of the plurality of leaflets comprise a tab extending only a portion of a length of each leaflet and configured to be secured to a respective commissure attachment region of the plurality of commissure attachment regions.

11. A prosthetic heart valve comprising:
a stent comprising a plurality of cells, a plurality of retaining arches comprising a plurality of bending edges and defining an outflow edge of the plurality of cells, and a plurality of commissure attachment regions; and
a prosthetic valve comprising a plurality of pieces, each piece of the prosthetic valve configured to be secured to at least one commissure attachment region of the plurality of commissure attachment regions and the plurality of cells via one or more sutures and further configured to be secured to a retaining arch of the plurality of retaining arches by one or more second sutures positioned around the bending edges of the retaining arches,
wherein the one or more second sutures secure each piece of the plurality of pieces of the prosthetic valve to a respective retaining arch of the plurality of retaining arches to define a transition area in each piece of the plurality of pieces, resulting in a skirt portion on an inflow side of the respective retaining arch and a prosthetic valve portion on an outflow side of the respective retaining arch, the prosthetic valve portion configured to transition between an open position and a closed position.

12. The prosthetic heart valve of claim 11 , wherein the prosthetic valve comprises natural tissue and/or synthetic material.

13. The prosthetic heart valve of claim 11 , wherein the stent further comprises a plurality of positioning arches configured to be inserted into cusps of native leaflets a native valve.

14. The prosthetic heart valve of claim 13 , wherein a native leaflet is positioned between each positioning arch of the plurality of positioning arches and each retaining arch of the plurality of retaining arches when plurality of positioning arches are inserted into the cusps of the native valve.

15. The prosthetic heart valve of claim 13 , wherein each positioning arch of the plurality of positioning arches is circumferentially aligned with each retaining arch of the plurality of retaining arches.

16. The prosthetic heart valve of claim 11 , wherein the bending edges of the plurality of retaining arches form fastening notches configured to receive the one or more sutures.

17. The prosthetic heart valve of claim 11 , wherein the bending edges divide each retaining arch of the plurality of retaining arches into a plurality of arm segments.

18. The prosthetic heart valve of claim 11 , wherein the plurality of commissure attachment regions is positioned at an outflow region of the stent.

19. The prosthetic heart valve of claim 11 , wherein the skirt portion and at least a portion of the plurality of cells are configured to form a seal against an inner wall of a blood vessel.

20. The prosthetic heart valve of claim 11 , wherein each pieces of the plurality of pieces of the prosthetic valve comprise a tab extending only a portion of a length of each leaflet and configured to be secured to a respective commissure attachment region of the plurality of commissure attachment regions.

Assignees

• Jenavalve Tech Inc

Inventors

• Girard Michael J
• Lane Randy
• Mayer Arnulf

Classifications

• A61F2220/0075

  sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable · CPC title

• A61F2240/001

  Designing or manufacturing processes · CPC title

• A61F2220/0025

  Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2/2412 Primary

  with soft flexible valve members, e.g. tissue valves shaped like natural valves · CPC title