HEART VALVE PROSTHESIS

• US 20150088248A1
• Filed: 04/26/2013
• Published: 03/26/2015
• Est. Priority Date: 04/27/2012
• Status: Active Grant

• Current Assignee: Epygon
• Original Assignee: Epygon SASU (Affluent Medical SA)
• Inventors: Scorsin, Marcio, Pasquino, Enrico
• Granted Patent: US 10,278,814 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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

1-22. -22. (canceled)

23. A heart valve prosthesis comprising a ring-shaped supporting structure to be anchored at the valve annulus, and a valve leaflet of flexible material floatingly supported by said supporting structure, characterized in that

said supporting structure comprises a support wall portion at which a root end of the valve leaflet is connected, and a complementary wall portion opposite to said support wall portion, which supports a static or quasi-static coaptation surface adapted to be sealingly engaged by a free end of the valve leaflet, and extending in a direction substantially parallel to the movement direction of the free end of the valve leaflet at the coaptation surface;

said free end of the valve leaflet is connected to said support wall portion or to said complementary wall portion by means of at least one traction member of flexible material, which is dimensioned to such a length that the movement of the free end of the valve leaflet is stopped at said coaptation surface.

24. A prosthesis according to claim 23, wherein said 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.

25. A prosthesis according to claim 23, wherein said coaptation surface is formed by an inner face of said complementary wall portion of the supporting structure.

26. A prosthesis according to claim 23, wherein said coaptation surface is formed by a quasi-static coaptation leaflet which comprises a root end connected to said complementary wall portion, and a free end connected to said support wall portion or to said complementary wall portion by means of at least one traction member of flexible material which is dimensioned to such a length that said coaptation leaflet is kept bent towards said complementary wall portion.

27. A prosthesis according to claim 23, wherein said supporting structure comprises a skeleton constituted by a valve stent, which is capable to assume a delivery configuration wherein the stent is collapsed, and an implantation configuration wherein the stent is expanded.

28. A prosthesis according to claim 23, wherein said supporting structure is configured for a sutureless implantation on the valve annulus.

29. A prosthesis according to claim 23, wherein said at least one traction member is connected to a post portion of said support wall portion or said complementary wall portion, said post portion axially protruding from the blood outflow side of said supporting structure.

30. A prosthesis according to claim 23, wherein at least one predetermined area of said supporting structure is provided with a positioning marker of material opaque to radiation of a predetermined wavelength.

31. A prosthesis according to claim 23, wherein there is a plurality of said 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.

32. A prosthesis according to claim 23, wherein said 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.

33. A prosthesis according to claim 23, wherein the supporting structure has a D-shaped cross section.

34. A prosthesis according to claim 33, 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.

35. A prosthesis according to claim 23, wherein the valve and the at least one traction member are constructed as a single piece, preferably as a single piece made of pericardium.

36. A prosthesis according to claim 23, wherein the at least one traction member is attached to lateral portions of the supporting structure.

37. A prosthesis according to claim 23, wherein ends of the supporting structure are flared outwardly with respect to a blood flow direction.

38. A prosthesis according to claim 37, wherein the flared ends are flared differently such that one end, preferably an inflow end, is flared with a wider angle with respect to the blood flow direction than an opposite end, preferably an outflow end.

39. A prosthesis having a support structure and at least one valve leaflet supported by said support structure, according to claim 23, wherein a supporting structure has an asymmetric arrangement such that one side, preferably the anterior side is axially shorter than an opposite side, preferably the posterior side.

40. A prosthesis having a support structure and at least one valve leaflet supported by said support structure, according to claim 23, wherein ends of the supporting structure are curvilinearly flared with respect to a blood flow direction.

41. A prosthesis having a support structure and at least one valve leaflet supported by said support structure, according to claim 23, wherein ends of the supporting structure are asymmetrically flared such that one side, preferably an anterior side, is flared with wider angle with respect to a blood flow direction than an opposite side, preferably a posterior side.

44. A prosthesis according to claim 23 which is adapted to be used as a mitral valve.

45. A delivery device comprising a prosthesis according to claim 23.

46. A method for manufacturing a heart valve prosthesis, according to claim 23, comprising the steps of

providing a support structure, preferably a D-shaped support structure with a support wall portion and a complementary wall portion,

assembling a valve leaflet of flexible material in the support structure,

wherein the valve leaflet is connected with a root end to the support wall or the complementary wall, preferably through stitching,

and a free end of the valve is attached to the other wall portion, the complementary wall portion or the support wall portion through a traction member.

47. A method according to claim 46, wherein the valve and the traction member are constructed as a single piece, preferably a single piece made of pericardium.

42. A prosthesis having a support structure, a support wall portion, a complementary wall portion and a single extended valve leaflet supported by said support structure, wherein said complementary wall portion supports a static or quasi-static coaptation surface adapted to be sealingly engaged by a free end of the valve leaflet.

43. A prosthesis according to claim 42 wherein the supporting structure has a D-shaped cross section.