Heart valve prosthesis

• US 10,278,814 B2
• Filed: 04/26/2013
• Issued: 05/07/2019
• Est. Priority Date: 04/27/2012
• Status: Active Grant

• Current Assignee: Epygon
• Original Assignee: Epygon
• Inventors: Scorsin, Marcio, Pasquino, Enrico
• Primary Examiner(s): Mathew, Seema
• Application Number:
  US14/396,254
• Publication Number:
  US 20150088248A1
• Time in Patent Office: 2,202 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0096 Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
• CPC Class Codes: Y10T 29/49838 by stringing

Abstract

Heart valve prosthesis, comprising a ring-shaped supporting structure (3) to be anchored at the valve annulus, and a valve leaflet (5) supported by the supporting structure. The supporting structure comprises a support wall portion (31), at which a root end (51) of the valve leaflet is connected, and a complementary wall portion (32) opposite the support wall portion, which supports a coaptation surface (33) adapted to be sealingly engaged by a free end (52) of the valve leaflet (5), and extending in a direction parallel to the direction of movement of the free end (52) of the valve leaflet (5) at the coaptation surface (33). The free end of the valve leaflet (5) is connected to the support wall portion or to the complementary wall portion by means of a traction member (55), dimensioned in such a way that the free end (52) of the valve leaflet (5) is stopped at the coaptation surface.

Claims

1. An atrio-ventricular valve prosthesis comprising:

a ring-shaped supporting structure to be anchored at the valve annulus; and

a single extended valve leaflet having a free end and a root end, made of flexible material floatingly supported by the supporting structure allowing for a movement of the free end within the supporting structure,

wherein the supporting structure includes,

a support wall portion at which the root end of the valve leaflet is connected, and

a complementary wall portion opposite to the support wall portion having a coaptation surface configured to be sealingly engaged with the free end of the valve leaflet, and extending in a direction substantially parallel to a movement direction of the free end of the valve leaflet at the coaptation surface,

wherein the free end of the valve leaflet is connected to the support wall portion or to the complementary wall portion by a traction member of flexible material having a length that the movement of the free end of the valve leaflet is stopped at the coaptation surface.

2. The prosthesis according to claim 1, wherein the coaptation surface extends in the direction parallel to the movement direction of the free end of the valve leaflet for a width (h) of at least 5 mm.

3. The prosthesis according to claim 1, wherein the coaptation surface is formed by an inner face of the complementary wall portion of the supporting structure.

4. The prosthesis according to claim 1, wherein the coaptation surface is formed by a quasi-static coaptation leaflet which comprises a root end connected to the complementary wall portion, and a free end connected to the support wall portion or to the complementary wall portion by the traction member of flexible material which is dimensioned to such a length that the coaptation leaflet is kept bent towards the complementary wall portion.

5. The prosthesis according to claim 1, wherein the supporting structure comprises a skeleton forming a valve stent, configured to assume a delivery configuration when the stent is collapsed, and an implantation configuration when the stent is expanded.

6. The prosthesis according to claim 1, wherein the supporting structure is configured for a sutureless implantation on the valve annulus.

7. The prosthesis according to claim 1, wherein the traction member is connected to a post portion of the support wall portion or the complementary wall portion, the post portion axially protruding from a blood outflow side of the supporting structure.

8. The prosthesis according to claim 1, wherein at least one predetermined area of the supporting structure is provided with a positioning marker of material opaque to radiation of a predetermined wavelength.

9. The prosthesis according to claim 1, wherein there are a plurality of the traction members having different lengths that are connected to a plurality of sites distributed along the edge of the free end of the valve leaflet.

10. The prosthesis according to claim 1, wherein the traction member constitutes an integral extension of the valve leaflet, and extends transversely along the entire edge of the free end of the valve leaflet.

11. The prosthesis according to claim 1, wherein the valve and the traction member are constructed as a single piece.

12. The prosthesis according to claim 1, wherein the valve and the traction member are constructed as a single piece made of pericardium.

13. The prosthesis according to claim 1, wherein the traction member is attached to lateral portions of the supporting structure.

14. The prosthesis according to claim 1, wherein ends of the supporting structure are flared outwardly with respect to a blood flow direction.

15. The prosthesis according to claim 14, wherein the flared ends are flared differently such that an inflow end is flared with a wider angle with respect to the blood flow direction than an outflow end.

16. The delivery device comprising a prosthesis according to claim 1.

17. The prosthesis according to claim 1, wherein the supporting structure has a D-shaped cross section in the area where the valve leaflet is contacting the structure.

18. The prosthesis according to claim 17, wherein the straight part of the D shape is the support wall portion or the complementary wall portion and the bent part of the D shape is the other wall portion, complementary wall portion or support wall portion, respectively.

19. The prosthesis according to claim 18, wherein the coaptation surface is arranged at an arc-shaped side of the D-shaped cross section of the supporting structure.

20. The prosthesis according to claim 18, wherein traction member reaches up to an edge of the supporting structure.

21. The prosthesis according to claim 1, wherein the ring-shaped supporting structure includes flares at an inflow end and flares at an outflow end, wherein the flares at an inflow end and the flares at an outflow end are asymmetrically arranged.