Everting Heart Valve

• US 20150245909A1
• Filed: 03/26/2015
• Published: 09/03/2015
• Est. Priority Date: 06/16/2004
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Haug, Ulrich R., Valencia, Hans F., Geshlider, Robert A., Saul, Tom, Morejohn, Dwight P., Michlitsch, Kenneth J.
• Application Number:
  US14/669,738
• Publication Number:
  US 20150245909A1
• Time in Patent Office: Days
• 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 2/2433 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 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• 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 2230/0078 hyperboloidal

Abstract

The present invention provides methods and apparatus for endovascularly replacing a patient'"'"'s heart valve. The apparatus includes a replacement valve and an expandable anchor configured for endovascular delivery to a vicinity of the patient'"'"'s heart valve. In some embodiments, the replacement valve is adapted to wrap about the anchor, for example, by everting during endovascular deployment. In some embodiments, the replacement valve is not connected to expandable portions of the anchor. In some embodiments, the anchor is configured for active foreshortening during endovascular deployment. In some embodiments, the anchor includes expandable lip and skirt regions for engaging the patient'"'"'s heart valve during deployment. In some embodiments, the anchor comprises a braid fabricated from a single strand of wire. In some embodiments, the apparatus includes a lock configured to maintain anchor expansion. The invention also includes methods for endovascularly replacing a patient'"'"'s heart valve. In some embodiments, the method includes the steps of endovascularly delivering a replacement valve and an expandable anchor to a vicinity of the heart valve, wrapping at least a portion of the replacement valve about the anchor, and expanding the anchor to a deployed, configuration.

Claims

1. -7. (canceled)

8. A medical device comprising:

an anchor configured to be deployed in a diseased heart valve;

a replacement valve disposed within an interior of the anchor; and

a seal having a bunched-up portion, the bunched-up portion disposed around the exterior of the anchor and adapted to prevent blood flow around the anchor when the anchor is deployed.

9. The medical device of claim 8, wherein the seal is a fabric seal.

11. The medical device of claim 8, wherein the bunched-up portion of the seal is adapted to be filled with a foam.

12. The medical device of claim 8, wherein the bunched-up portion of the seal is adapted to be filled with a hydrogel.

13. The medical device of claim 8, wherein the bunched-up portion of the seal is adapted to be filled with water.

10. The medical device of 8, wherein the bunched-up portion of the seal is adapted to fill with blood in response to backflow blood pressure.

14. A medical device comprising:

an anchor configured to be deployed in a diseased heart valve;

a replacement valve disposed within the interior of the anchor; and

a seal having an exterior portion disposed around an exterior of the anchor, the exterior portion of the seal comprising one or more sacs, the sacs adapted to prevent blood flow around the anchor when the anchor is deployed.

15. The medical device of claim 14, wherein the seal is a fabric seal.

16. The medical device of claim 14, wherein the one or more sacs are adapted to fill with blood in response to backflow blood pressure.

17. The medical device of claim 14, wherein the one or more sacs are continuously cylindrical.

18. The medical device of claim 14, wherein the one or more sacs are adapted to be filled with a foam.

19. The medical device of claim 14, wherein the one or more sacs are adapted to be filled with hydrogel.

20. The medical device of claim 14, wherein the one or more sacs are adapted to be filled with water.

21. A medical device comprising:

an expandable anchor configured to be deployed in a diseased heart valve;

a replacement heart valve disposed within an interior of the expandable anchor; and

a seal that, during delivery, extends from a distal end of the replacement valve, within the interior of the expandable anchor, and back proximally over an exterior of the anchor.

22. The medical device of claim 21 wherein, when deployed, the portion of the seal exterior to the anchor bunches up and extends into spaces formed by native valve leaflets of the diseased heart valve.

23. The medical device of claim 21, wherein the seal includes at least one pocket disposed around the exterior of the anchor.

24. The medical device of claim 23, wherein the at least one pocket is adapted to prevent blood flow around the anchor when the anchor is deployed.

25. The medical device of claim 23, wherein the at least one pocket is adapted to fill with blood in response to backflow blood pressure and to extend into spaces formed by native leaflets of the diseased heart valve, thereby forming a seal around the anchor.

26. The medical device of claim 23, wherein the at least one pocket is continuously cylindrical.

27. The medical device of claim 26, wherein the at least one continuously cylindrical pocket is disposed around a distal region of the anchor.