Prosthetic heart valve having flared outflow section

• US 8,206,438 B2
• Filed: 02/16/2011
• Issued: 06/26/2012
• Est. Priority Date: 03/23/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yang, Jibin, Pease, Matthew L., Walsh, Brandon G.
• Primary Examiner(s): Pellegrino, Brian E
• Assistant Examiner(s): MILLER, CHERYL L
• Application Number:
  US13/029,033
• Publication Number:
  US 20110137409A1
• Time in Patent Office: 496 Days
• Field of Search: 623 124- 126, 623 212- 219, 623/900
• US Class Current: 623/2.14
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/006 modular
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

Expandable, percutaneously deployable, prosthetic heart valves and systems for minimally invasive replacement of damaged or diseased native aortic valves comprise an expandable, tubular stent body and a unidirectional valve assembly. Embodiments of the stent body comprise an annulus anchoring section, a sinus section, and an outflow section, with the outflow section flared outward from the sinus section in an expanded configuration. Embodiments of the stent body are self-expanding, comprising, for example nitinol. The valve assembly disposed within the sinus section of the stent body and sutured thereto. Embodiments of the valve assembly comprise three leaflets, each leaflet comprising a curved outer edge sutured to the sinus section of the stent body, and a coapting free edge. Embodiments of the valve leaflets comprise pericardium. Embodiments of the prosthetic heart valve have a contracted configuration dimensioned for percutaneous delivery thereof.

Claims

1. A percutaneously deployable prosthetic aortic valve for replacing a damaged or diseased native aortic valve, the prosthetic aortic valve comprising:

a self-expanding, tubular stent body having an axial axis, an inflow end, and an outflow end, the stent body comprising a one-piece, nitinol wall defining an interior and an exterior of the stent body, the wall of the stent body comprising, from the inflow end to the outflow end of the prosthetic valve, an annulus anchoring section, a sinus section, and an outflow section, the sinus section of the wall of the stent body comprising a plurality of apertures dimensioned to permit blood flow therethrough, and the outflow section of the wall comprising at least one of an apertured lattice, a mesh, and a grid pattern; and

a valve structure disposed within an interior of the sinus section of the stent body wall, the valve structure having an open state permitting blood flow from the inflow end to the outflow end of the prosthetic valve, and a closed state preventing blood flow from the outflow end to the inflow end of the prosthetic valve, the valve structure comprising three pericardium membrane leaflets, each leaflet comprising a free edge and a curved outer edge, the free edges of the leaflets dimensioned to coapt when the valve structure is in the closed state, the free edges of the leaflets meet the stent body at axially extending commissures, and the outer edges of the leaflets sutured to the sinus section of the stent body wall;

wherein the prosthetic valve has a contracted configuration and an expanded configuration, in the expanded configuration, the outflow section of the stent body wall is flared outward from the sinus section for providing the outflow end with an expanded diameter larger than an expanded diameter at the inflow end, the flared outflow section of the stent body wall is dimensioned to contact an ascending aorta above the native aortic valve and is flexible for accommodating aortic wall movement, the annulus anchoring section is more rigid than the flared outflow section for providing a support structure for the leaflets, and the annulus anchoring section of the stent body wall is dimensioned to engage an annulus of the native aortic valve, and in the contracted configuration, the prosthetic valve is dimensioned for percutaneous delivery via a delivery catheter.

2. A system for replacing a damaged or diseased native aortic valve, the system comprising:

a flexible, elongate delivery catheter; and

a collapsible and expandable prosthetic heart valve adapted to be inserted into a distal end portion of the delivery catheter, the prosthetic heart valve comprising;

a self-expandable stent body having an axial axis, an inflow end and an outflow end, the stent body made of nitinol, the stent body comprising a wall defining an interior and an exterior of the stent body, the wall of the stent body comprising, from the inflow end to the outflow end of the prosthetic valve, an annulus anchoring section, a sinus section, and an outflow section, the sinus section of the wall of the stent body comprising a plurality of apertures dimensioned to permit blood flow therethrough, and the outflow section of the wall comprising at least one of an apertured lattice, a mesh, and a grid pattern; and

a valve structure disposed within an interior of the sinus section of the stent body wall, the valve structure having an open state permitting blood flow from the inflow end to the outflow end of the prosthetic valve, and a closed state preventing blood flow from the outflow end to the inflow end of the prosthetic valve, the valve structure comprising three pericardium membrane leaflets, each leaflet comprising a free edge and a curved outer edge, the free edges of the leaflets dimensioned to coapt when the valve structure is in the closed state, the free edges of the leaflets meet the stent body at axially extending commissures, and the outer edges of the leaflets sutured to the sinus section of the stent body;

wherein the prosthetic valve has a contracted configuration and an expanded configuration, in the expanded configuration, the outflow section of the stent body wall is flared outward from the sinus section for providing the outflow end with an expanded diameter larger than an expanded diameter at the inflow end, the flared outflow section of the stent body wall is dimensioned to contact an ascending aorta above the native aortic valve and the flared outflow section is flexible for accommodating aortic wall movement, the annulus anchoring section is more rigid than the flared outflow section for providing a support structure for the leaflets, and the annulus anchoring section of the stent body wall is dimensioned to engage an annulus of the native aortic valve, and in the contracted configuration, the prosthetic valve is dimensioned for percutaneous delivery via the delivery catheter.

3. The system of claim 2, wherein the wall of the stent body is a one-piece wall.

4. The system of claim 2, wherein, in the contracted configuration, the stent body is rolled axially.

5. The system of claim 4, wherein the stent body comprises a first side edge and a second side edge, the first side edge and the second side edge extending axially, and the first side edge mating with the second side edge in the expanded configuration.

6. The system of claim 5, wherein the first edge and second edge of the stent body comprise corresponding tabs and slots that engage each other in the expanded configuration.

7. The system of claim 2, wherein the annulus anchoring section of the wall of stent body is substantially solid.

8. The system of claim 2, wherein the valve leaflets comprise bovine pericardium.

9. The system of claim 2, wherein the curved outer edge of each leaflet is substantially semi-circular.

10. The system of claim 2, wherein the sinus section of the wall of the stent body further comprises a plurality of attachment apertures through which the leaflets of the valve structure are sutured.

11. The system of claim 2, wherein a diameter of the prosthetic valve in the contracted configuration is less than about 20 mm.

12. The system of claim 2, further comprising a pusher dimensioned to advance the prosthetic heart valve in the contracted configuration through the delivery catheter.