Method for treating an aortic valve

• US 9,241,788 B2
• Filed: 06/21/2012
• Issued: 01/26/2016
• 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): Sweet, Thomas J
• Assistant Examiner(s): Miller, Cheryl
• Application Number:
  US13/529,955
• Publication Number:
  US 20130023983A1
• Time in Patent Office: 1,314 Days
• Field of Search: 623/1.24, 623/1.16, 623 212- 219, 623/900
• 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 2/2436 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 outwardly 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 method for treating a damaged or diseased native aortic valve, the method comprising:

inserting a delivery catheter into a patient;

loading a prosthetic heart valve in a contracted configuration into the delivery catheter, the prosthetic heart valve comprising a one-way valve structure and a one-piece, tubular stent body defining a flow orifice therethrough, the tubular stent body comprising, from an inflow end to an outflow end thereof, an annulus anchoring section, a sinus section, and an outflow section, the one-way valve structure disposed within the sinus section, wherein the valve structure comprises three bovine pericardium membranes disposed within the sinus section of the tubular stent body, each membrane comprising a free edge and an outer edge portion, the free edges of the membranes meeting in the flow orifice and coapting with each other in a closed position and flexing open against the tubular stent body in an open position, the outer edge portions of the membranes sutured to the sinus section, the free edges meeting one another at axially extending commissures of the sinus section;

positioning a distal end of the delivery catheter adjacent a native aortic valve;

retracting the delivery catheter relative to the prosthetic heart valve, thereby delivering the prosthetic heart valve from the distal end of the delivery catheter into an annulus of the native aortic valve;

expanding the annulus anchoring section of the tubular stent body into an expanded configuration in the annulus of the native aortic valve, thereby anchoring the annulus anchoring section in the annulus and compressing native leaflets of the aortic valve; and

expanding an outflow section of the tubular stent body into an expanded configuration in an ascending aorta, the outflow section flaring outwardly from the sinus section, the outflow section conforming to and contacting the ascending aorta, thereby stabilizing the prosthetic heart valve.

2. The method of claim 1, wherein inserting a delivery catheter into the patient comprises inserting a chest cannula into the patient.

3. The method of claim 1, wherein inserting a delivery catheter into a patient comprises inserting the delivery catheter percutaneously into the patient.

4. The method of claim 1, further comprising advancing the prosthetic heart valve through the delivery catheter.

5. The method of claim 4, wherein advancing the prosthetic heart valve through the delivery catheter comprises using a pusher to advance the prosthetic heart valve.

6. The method of claim 1, further comprising rolling the tubular stent body axially into the contracted configuration.

7. The method of claim 1, wherein expanding the annulus anchoring section of the tubular stent body comprises expanding the annulus anchoring section using a balloon.

8. The method of claim 1, wherein expanding the annulus anchoring section of the tubular stent body comprises allowing the annulus anchoring section to self-expand.

9. The method of claim 1, wherein expanding the outflow section of the tubular stent body comprises expanding the outflow section using a balloon.

10. The method of claim 1, wherein expanding the outflow section of the tubular stent body comprises allowing the outflow section to self-expand.

11. The method of claim 1, wherein the sinus section of the tubular stent body comprises a plurality of sinus apertures and the outflow section comprises at least one of a lattice, a mesh, or a grid.

12. The method of claim 11, wherein the outflow section comprises a plurality of diamond-shaped apertures.

13. The method of claim 1, wherein the sinus section of the stent body includes three apertures and each pericardium membrane fastens around one of the tubular apertures with sutures.

14. The method of claim 1, wherein the tubular stent body is nitinol.

15. The method of claim 1, wherein the annulus anchoring section is more rigid than the flared outflow section.

16. A method for treating a damaged or diseased native aortic valve, the method comprising:

percutaneously inserting a delivery catheter into a patient;

loading a prosthetic heart valve in a contracted configuration into the delivery catheter, the prosthetic heart valve comprising a one-way valve structure and a one-piece, nitinol, tubular stent body comprising, from an inflow end to an outflow end thereof, an annulus anchoring section, a sinus section, and an outflow section, the one-way valve structure disposed within the sinus section, wherein the valve structure comprises three pericardium membranes disposed within the sinus section of the tubular stent body, each membrane comprising a free edge and an outer edge portion, the free edges of the membranes coapting with each other to define a one-way valve, the outer edge portions of the membranes sutured to the sinus section, the free edges meeting one another at axially extending commissures of the sinus section;

advancing the prosthetic heart valve through the delivery catheter;

positioning a distal end of the delivery catheter adjacent a native aortic valve;

retracting the delivery catheter relative to the prosthetic heart valve, thereby delivering the prosthetic heart valve from the distal end of the delivery catheter into an annulus of the native aortic valve;

allowing the annulus anchoring section of the tubular stent body to self-expand into an expanded configuration in the annulus of the native aortic valve, thereby anchoring the annulus anchoring section in the annulus and compressing native leaflets of the aortic valve; and

allowing the outflow section of the tubular stent body to self-expand in an ascending aorta to an expanded configuration, the outflow section flaring outwardly from the sinus section, the outflow section conforming to and contacting the ascending aorta, the outflow section being flexible to accommodate movement of the ascending aorta, thereby stabilizing the prosthetic heart valve, wherein

the sinus section of the tubular stent body comprises a plurality of sinus apertures and the outflow section comprises a plurality of diamond-shaped apertures,

and the annulus anchoring section is more rigid than the flared outflow section.

17. The method of claim 16, wherein advancing the prosthetic heart valve through the delivery catheter comprises using a pusher to advance the prosthetic heart valve.

18. The method of claim 16, further comprising rolling the tubular stent body axially into the contracted configuration.

19. The method of claim 16, wherein loading the prosthetic heart valve in a contracted configuration comprises loading the prosthetic heart valve, wherein the sinus section of the tubular stent body comprises a plurality of sinus apertures and the outflow section comprises at least one of a lattice, a mesh, or a grid.