Heart valve anchor and method

• US 20050137687A1
• Filed: 12/23/2003
• Published: 06/23/2005
• Est. Priority Date: 12/23/2003
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Krolik, Jeff, Valencia, Hans F., Morejohn, Dwight P., Haug, Ulrich R., Brandt, Brian D., Geshlider, Robert A., Salahieh, Amr, Dueri, Jean-Pierre
• Application Number:
  US10/746,240
• Publication Number:
  US 20050137687A1
• Time in Patent Office: Days
• US Class Current: 623/2.110
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/243 Deployment by mechanical expansion
• 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 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/9528 for retrieval of stents
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/006 modular

Abstract

Apparatus for endovascularly replacing a patient'"'"'s heart valve. In some embodiments the apparatus includes an expandable anchor with a lip region and a skirt region; and a replacement valve, wherein the lip region and skirt region are configured for percutaneous expansion to engage leaflets of the heart valve. The invention is also a method for endovascularly replacing a patient'"'"'s heart valve. In some embodiments the method includes the steps of endovascularly delivering apparatus including an anchor having lip and skirt regions, and a replacement valve coupled to the anchor, to a vicinity of the heart valve in a collapsed delivery configuration; and expanding the apparatus such that leaflets of the heart valve are captured between the lip and skirt regions of the anchor.

Claims

1. Apparatus for endovascularly replacing a patient'"'"'s heart valve, the apparatus comprising:

an expandable anchor comprising a lip region and a skirt region; and

a replacement valve,

wherein the lip region and skirt region are configured for percutaneous expansion to engage leaflets of the heart valve.

2. The apparatus of claim 1 wherein the lip region and skirt region are configured for independent expansion.

3. The apparatus of claim 1 wherein the lip region and skirt region are configured for concurrent expansion.

4. The apparatus of claim 1 wherein the lip region is adapted to preclude distal migration of the apparatus post-deployment and expansion.

5. The apparatus of claim 1 wherein the skirt section is adapted to preclude proximal migration of the apparatus post-deployment and expansion.

6. The apparatus of claim 1 wherein the anchor is at least partially covered by a biocompatible film.

7. The apparatus of claim 1 wherein the replacement valve is configured to be coupled to the anchor during percutaneous delivery.

8. The apparatus of claim 1 wherein the anchor and the replacement valve are adapted for expansion from the delivery to the deployed configurations via a mechanism chosen from the group consisting of balloon-expansion, self-expansion, and combinations thereof.

9. The apparatus of claim 1 further comprising a delivery system configured for percutaneous advancement of the apparatus to a vicinity of the patient'"'"'s diseased valve while the anchor is disposed in a collapsed delivery configuration.

10. The apparatus of claim 9 wherein the delivery system facilitates deployment and expansion of the apparatus to endovascularly replace the heart valve.

11. The apparatus of claim 10 wherein the delivery system is configured to retrieve the apparatus.

12. The apparatus of claim 1 further comprising at least one locking element configured to maintain expansion of the lip region and the skirt region.

13. A method for endovascularly replacing a patient'"'"'s heart valve, the method comprising:

endovascularly delivering apparatus comprising an anchor having lip and skirt regions, and a replacement valve coupled to the anchor, to a vicinity of the heart valve in a collapsed delivery configuration;

expanding the apparatus such that leaflets of the heart valve are captured between the lip and skirt regions of the anchor.

14. The method of claim 13, wherein expanding the apparatus further comprises dynamically repositioning the apparatus relative to the heart valve prior to capturing the leaflets.

15. The method of claim 13, wherein expanding the apparatus further comprises expanding either the lip region or the skirt region, positively engaging the heart valve with the expanded lip or skirt region, and then expanding the unexpanded region.

16. The method of claim 13 wherein expanding the apparatus further comprises retrieving the apparatus, repositioning the apparatus, and redeploying the apparatus.

17. The method of claim 13 further comprising locking the apparatus in the expanded configuration.

18. The method of claim 13, wherein capturing the leaflets further comprises precluding proximal and distal migration of the apparatus relative to the patient'"'"'s diseased valve.