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

• US 7,445,631 B2
• Filed: 07/15/2004
• Issued: 11/04/2008
• Est. Priority Date: 12/23/2003
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Valencia, Hans F., Morejohn, Dwight P., Haug, Ulrich R., Geshlider, Robert A., Salahieh, Amr, Saul, Tom
• Primary Examiner(s): Matthews; William H.
• Application Number:
  US10/893,142
• Publication Number:
  US 20050137702A1
• Time in Patent Office: 1,573 Days
• Field of Search: 623 113- 122, 623/1.24, 623 21- 219
• US Class Current: 623/2.18
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2415 Manufacturing methods
• 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 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 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

The present invention relates to an apparatus for replacing a native aortic valve, the apparatus includes an expandable anchor adapted to be endovascularly delivered and secured at a site within the native aortic valve. The expandable anchor has a delivery length in a delivery configuration substantially greater than a deployed length in a deployed configuration. The apparatus may also include and a replacement valve configured to be secured within the anchor.

Claims

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

an expandable anchor adapted to be endovascularly delivered and secured at an anchor site within the native aortic valve, the expandable anchor having a delivery length in a delivery configuration substantially greater than a deployed length in a deployed configuration, a proximal end, and a distal end; and

a replacement valve configured to be secured within the anchor, wherein the anchor delivery length is between about 15 mm and about 150 mm and the anchor deployed length is between about 2 mm and about 40 mm, wherein a deployment system is reversibly coupled to the proximal end of the anchor and to a distal region of the anchor, and wherein the deployment system is adapted to apply a distally directed force on the proximal end of the anchor and a proximally directed force on the distal end of the anchor to foreshorten the anchor.

2. The apparatus of claim 1 wherein the delivery length is between about 20 mm and about 140 mm and the deployed length is between about 5 mm and about 30 mm.

3. The apparatus of claim 1 wherein the delivery length is between about 25 mm and about 130 mm and the deployed length is between about 7 mm and about 20 mm.

4. The apparatus of claim 1 wherein the anchor has an at-rest configuration and wherein the anchor comprises a shape memory material that is heat set in the at-rest configuration.

5. The apparatus of claim 4 wherein the at-rest configuration has a length between the delivery length and the deployed length.

6. The apparatus of claim 1 wherein the anchor is configured for active foreshortening during endovascular deployment.

7. The apparatus of claim 1 further comprising a lock configured to maintain expansion of the anchor.

8. The apparatus of claim 1 further comprising a plurality of locks configured to maintain expansion of the anchor.

9. The apparatus of claim 8 wherein the plurality of locks are further configured to maintain expansion of the anchor at a plurality of amounts of expansion.

10. The apparatus of claim 1 further comprising a valve support adapted to support the replacement valve within the anchor.

11. The apparatus of claim 10 further comprising a lock configured to maintain expansion of the anchor.

12. The apparatus of claim 11 wherein the lock comprises an extension of the valve support.

13. The apparatus of claim 11 wherein the lock is configured to maintain expansion of the anchor by axially constraining the anchor in the deployed configuration.

14. The apparatus of claim 1 wherein the deployment system is reversibly coupled to the distal region at a distal deployment system interface, the distal deployment system interface being adapted to permit the deployment system to apply the proximally directed force on the distal end of the anchor.

15. The apparatus of claim 14 wherein the distal deployment system interface is further adapted to expand radially during application of the proximally directed force on the distal end of the anchor.

16. The apparatus of claim 15 wherein the distal deployment system interface is further adapted to permit the deployment system to apply the proximally directed force on the distal end of the anchor without passing any portion of the deployment system through a center opening of the replacement valve.

17. The apparatus of claim 1 wherein the anchor comprises a proximal deployment system interface at the proximal end of the anchor, wherein the proximal deployment system interface is further adapted to expand radially during application of the distally directed force on the proximal end of the anchor.

18. The apparatus of claim 1 wherein the deployment system comprises a plurality of fingers reversibly coupled to the proximal end of the anchor, and wherein the plurality of fingers are adapted to apply the distally directed force on the proximal end of the anchor.

19. The apparatus of claim 1 wherein the deployment system is reversibly coupled to the proximal end of the anchor after the anchor is delivered outside of a delivery catheter.

20. An apparatus for replacing a native aortic valve, the apparatus comprising:

an expandable anchor adapted to be endovascularly delivered and deployed at an anchor site within the native aortic valve,

a replacement valve secured within the anchor, and

a deployment system reversibly coupled to a proximal region of the anchor and to a distal region of the anchor,

wherein the deployment system is adapted to apply a distally directed force on the proximal region of the anchor and a proximally directed force on the distal region of the anchor to foreshorten and expand the anchor.

21. The apparatus of claim 20 further comprising a lock configured to maintain the anchor is a fully deployed configuration.