PROSTHETIC HEART VALVE HAVING FLARED OUTFLOW SECTION

• US 20110137409A1
• Filed: 02/16/2011
• Published: 06/09/2011
• Est. Priority Date: 03/23/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Yang, Jibin, Walsh, Brandon G., Pease, Matthew L.
• Granted Patent: US 8,206,438 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 2/2418 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, for example, porcine 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 heart valve comprising:

an axial axis, an inflow end, and an outflow end;

an expandable, tubular 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 the interior 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 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 a expanded configuration, in the expanded configuration, the outflow section of the stent body wall is flared outward from the sinus section, the flared outflow section of the stent body wall is dimensioned to contact an ascending aorta above the native heart valve, 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.

2. The prosthetic heart valve of claim 1, wherein the stent body is self-expanding.

3. The prosthetic heart valve of claim 2, wherein the wall of the stent body comprises nitinol.

4. The prosthetic heart valve of claim 2, wherein the wall of the stent body is a one-piece wall.

5. The prosthetic heart valve of claim 1, wherein, in the contracted configuration, the stent body is rolled axially.

6. The prosthetic heart valve of claim 5, 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.

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

8. The prosthetic heart valve of claim 1, wherein the annulus anchoring section of the wall of stent body is substantially solid.

9. The prosthetic heart valve of claim 1, wherein the valve leaflets comprise at least one of porcine and bovine pericardium.

10. The prosthetic heart valve of claim 1, wherein the curved edge of each leaflet is substantially semi-circular.

11. The prosthetic heart valve of claim 1, wherein the sinus portion of the wall of the stent body further comprises a plurality of attachment apertures through which the leaflets of the valve structure are sutured.

12. The prosthetic heart valve of claim 1, wherein a diameter of the prosthetic valve in the contracted configuration is less than about 20 mm.

13. An system for replacing a damaged or diseased native aortic heart valve, the system comprising:

the prosthetic heart valve of claim 1; and

a catheter or delivery tube dimensioned for percutaneous access of a native aortic valve, the catheter or delivery tube comprising a lumen dimensioned to receive the prosthetic heart valve in the contracted configuration.

14. The system of claim 13, further comprising a pusher dimensioned to advance the prosthetic heart valve in the contracted configuration through the lumen of the catheter or delivery tube.

15. The system of claim 13, further comprising an expansion balloon having a deflated state and an inflated state, the expansion balloon in the deflated state dimensioned to carry the prosthetic heart valve in the contracted configuration, and the expansion balloon in the inflated state dimensioned to convert the prosthetic heart valve carried thereon into the expanded configuration.

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

an axial axis, an inflow end, and an outflow end;

an self-expanding, tubular 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 the interior 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 porcine 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 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 a expanded configuration,

in the expanded configuration, the outflow section of the stent body wall is flared outward from the sinus section, the flared outflow section of the stent body wall is dimensioned to contact an ascending aorta above the native heart valve, 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.