Prosthetic Monoleaflet Valve and Delivery Device

• US 20160367359A1
• Filed: 03/09/2015
• Published: 12/22/2016
• Est. Priority Date: 03/11/2014
• Status: Active Grant

• Current Assignee: Epygon
• Original Assignee: Epygon
• Inventors: Pasquino, Enrico, Scorsin, Marcio, Casalegno, Sergio
• Granted Patent: US 10,779,934 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• 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 2230/0034 D-shaped
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic valve, preferably an expandable prosthetic valve, having a valve component (3), preferably a mitral valve component, made of a single functional leaflet (6) wherein the prosthetic valve (1) comprises at least two tissue supports (4′, 4″,4′″,4″″) attachable to an inner surface (5) of a stent component (2), wherein at least one tissue support (4′, 4″,4′″,4″″) comprises at least one attachment area (7′, 7″), at least a section of the attachment area extending essentially inwardly from the inner surface (5), wherein said leaflet (6) is attached to at least one tissue support (4′, 4″,4′″,4′″) at the section of said attachment area(s) (7′, 7″) such that the leaflet (6) is arranged between said attachment area(s) (7′,7″) or integrally formed with one tissue support (4′,4″,4′″,4″″) and attached to the second tissue support (4′,4″,4′″,4″″) at the section of the attachment area(s) (7′,7″).

Claims

1-15. -15. (canceled)

16. A prosthetic valve comprising:

a first tissue support and a second tissue support, each attachable to an inner surface of a stent component, the first tissue support including an attachment area, a section of the attachment area extending essentially inwardly away from the inner surface of the stent component; and

a single functional leaflet as a valve component,

wherein the single functional leaflet is attached to the first tissue support at the section of the attachment area such that the single functional leaflet is arranged between the attachment area of the first tissue support and the second tissue support, or the single functional leaflet is integrally formed with the first tissue support and attached to the second tissue support at a section of an attachment area of the second tissue support.

17. The prosthetic valve according to claim 16, wherein the first and the second tissue supports are attached to the inner surface of the stent component and are at least partly covering the inner surface of the stent component.

18. The prosthetic valve according to claim 16, wherein the single functional leaflet is elastic and has sutures that are arranged at a minimum distance of 1 mm from the attachment area of the first tissue support, such that the single functional leaflet elastically absorbs chain shock during systo-diastolic leaflet opening and closure.

19. The prosthetic valve according to claim 16, wherein the single functional leaflet is elastic and has sutures arranged at a minimum distance of 2 mm from the attachment area of the first tissue support, such that stress generated by the single functional leaflet along an insertion line to the first and second tissue supports are evenly distributed to the inner surface of the stent component.

20. The prosthetic valve according to claim 16, wherein the single functional leaflet is arranged between the first and second tissue supports, and the first and second tissue supports are separated from each other.

21. The prosthetic valve according to claim 20, wherein

each first and second tissue supports have an attachment area, and the inner surface of the stent component between the attachment areas of the first and second tissue supports is not covered with the first and second tissue supports.

22. The prosthetic valve according to claim 16, wherein the single functional leaflet is integrally formed with a tissue support of the first and the second tissue supports that is positioned at an inflow end of the prosthetic valve.

23. The prosthetic valve according to claim 16, wherein the single functional leaflet is integrally formed with a tissue support of the first and the second tissue supports that is positioned at an outflow end of the prosthetic valve.

24. The prosthetic valve according to claim 16, wherein the single functional leaflet is integrally formed with the first tissue support, and

wherein both the first tissue support and the single functional leaflet have tubular shapes.

25. The prosthetic valve according to claim 16, wherein the single functional leaflet is attached to the attachment area of the first tissue support with sutures.

26. The prosthetic valve according to claim 16, wherein the first and the second tissue supports are attached to the inner surface of the stent component with sutures.

27. The prosthetic valve according to claim 16, wherein at least one of the single functional leaflet, the first tissue support, and the second tissue support are substantially made of pericardium.

28. The prosthetic valve according to claim 16, wherein the prosthetic valve is self-expandable.

29. The prosthetic valve according to claim 16, wherein the attachment area has a length in a range between 2 mm to 10 mm.

30. The prosthetic valve according to claim 16, wherein the single functional leaflet forms a mitral valve component.

31. The prosthetic valve according to claim 18, wherein the sutures are arranged at a distance in a range between 1 mm and 5 mm.

32. A delivery system comprising:

a delivery device; and

a prosthetic valve including,

a first tissue support and a second tissue support, each attachable to an inner surface of a stent component, the first tissue support including an attachment area, a section of the attachment area extending essentially inwardly away from the inner surface of the stent component; and

a single functional leaflet as a valve component,

wherein the single functional leaflet is attached to the first tissue support at the section of the attachment area such that the single functional leaflet is arranged between the attachment area of the first tissue support and the second tissue support, or the single functional leaflet is integrally formed with the first tissue support and attached to the second tissue support at a section of an attachment area of the second tissue support.