Methods and apparatus for endovascularly replacing a patient's heart valve

• US 20070162107A1
• Filed: 03/09/2007
• Published: 07/12/2007
• Est. Priority Date: 12/23/2003
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Valencia, Hans, Salahieh, Amr, Saul, Tom, Morejohn, Dwight, Geshlider, Robert, Haug, Ulrich
• Granted Patent: US 8,246,678 B2
• Time in Patent Office: Days
• US Class Current: 623/1.260
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

The present invention provides methods and apparatus for endovascularly replacing a patient'"'"'s heart valve. The apparatus includes a replacement valve and an anchor having an expandable braid. In some embodiments, the expandable braid is fabricated from a single strand of wire. In some embodiments, the expandable braid comprises at least one turn feature. The anchor and the valve preferably are configured for endovascular delivery and deployment.

Claims

1. Apparatus for replacing a native aortic valve, the apparatus comprising:

an anchor comprising an expandable braid, the anchor being adapted to be endovascularly delivered and expanded via active foreshortening at an anchor site within the native aortic valve; and

a replacement valve configured to be secured within the anchor.

2. The apparatus of claim 1 wherein the anchor comprises a central axis, the anchor being further adapted to remain substantially undeformed in response to a pressure up to 0.5 atm directed substantially radially inward toward the central axis.

3. The apparatus of claim 2 wherein the anchor is further adapted to remain substantially undeformed in response to a pressure up to 2 atm directed substantially radially inward toward the central axis.

4. The apparatus of claim 1 wherein the braid comprises a first region and a second region having a diameter larger than a diameter of the first region when the anchor is expanded.

5. The apparatus of claim 4 wherein the braid defines a plurality of cells, at least a first set of the cells in the first region each being of a substantially different configuration than a second set of the cells in the second region.

6. The apparatus of claim 5 wherein the braid further comprises a third region having a diameter larger than the first region diameter when the anchor is expanded.

7. The apparatus of claim 6 wherein the braid defines a plurality of cells, at least a first set of the cells in the first region each being of a substantially different configuration than a second set of the cells in the second region and a third set of cells in the third region.

8. The apparatus of claim 1 wherein the anchor is further adapted to avoid interference with coronary ostia.

9. The apparatus of claim 1 wherein the anchor is further adapted to avoid interference with a mitral valve.

10. The apparatus of claim 9 wherein the braid comprises a region adapted to prevent expansion of the anchor into the mitral valve.

11. The apparatus of claim 1 wherein the braid is configured to have an expanded shape that is radially symmetrical.

12. The apparatus of claim 1 wherein the braid is configured to have an expanded shape that is bilaterally symmetrical.

13. The apparatus of claim 1 wherein the delivery length is between about 15 mm and about 150 mm and the deployed length is between 5 mm and about 40 mm.

14. The apparatus of claim 1 wherein the braid is configured to have an expanded shape that is asymmetrical.

15. The apparatus of claim 1 wherein the anchor comprises first and second wires, the first wire having a diameter smaller than a diameter of the second wire.

16. The apparatus of claim 1 wherein the anchor comprises first and second wires formed from different materials.

17. The apparatus of claim 1 wherein the anchor has a collapsed delivery configuration, an at-rest configuration and an expanded deployed configuration.

18. The apparatus of claim 17 wherein the braid comprises a shape memory material that is heat set in the at-rest configuration.

19. The apparatus of claim 17 wherein the at-rest configuration is between the collapsed delivery configuration and expanded deployed configuration.

20. The apparatus of claim 1 further comprising a lock configured to maintain expansion of the braid.