Everting heart valve

• US 8,668,733 B2
• Filed: 11/12/2008
• Issued: 03/11/2014
• Est. Priority Date: 06/16/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Sadra Medical, Inc. (Boston Scientific Corporation)
• Inventors: Haug, Ulrich R., Valencia, Hans F., Geshlider, Robert A., Saul, Tom, Salahieh, Amr, Morejohn, Dwight P., Michlitsch, Kenneth J.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): SCHILLINGER, ANN M
• Application Number:
  US12/269,213
• Publication Number:
  US 20090076598A1
• Time in Patent Office: 1,945 Days
• Field of Search: 623 21- 242
• US Class Current: 623/2.18
• 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. A system for replacing a heart valve, comprising:

a replacement heart valve, the replacement heart valve having;

an expandable anchor comprising a braided material, and

a replacement valve comprising an everting segment;

a delivery device, wherein the expandable anchor and the replacement valve are adapted to be delivered within the delivery device to a vicinity of a heart valve, and wherein the expandable anchor has a delivery configuration within the delivery device; and

a plurality of delivery system actuation elements reversibly coupled to a proximal end of the replacement heart valve when the expandable anchor is in the delivery configuration,

wherein the expandable anchor is axially spaced from the replacement valve when the expandable anchor is in the delivery configuration within the delivery device.

2. The system of claim 1 wherein the expandable anchor and the replacement valve are coupled to each other.

3. The system of claim 1 wherein the replacement valve is distally spaced from the expandable anchor when the expandable anchor is in the delivery configuration within the delivery device.

4. The system of claim 1 wherein at least a portion of the replacement valve is disposed within the expandable anchor when the expandable anchor is in a fully deployed configuration.

5. The system of claim 4 wherein at least a portion of the replacement valve is disposed axially within the expandable anchor when the expandable anchor is in the fully deployed configuration.

6. The system of claim 1 wherein the plurality of delivery system actuation elements remain reversibly coupled to the replacement heart valve after the expandable anchor is deployed from the delivery device.

7. The system of claim 1 wherein the plurality of actuation elements are adapted to apply a distally directed force on the replacement heart valve when reversibly coupled thereto.

8. A system for replacing a heart valve, comprising:

a replacement heart valve having;

an expandable anchor comprising a braided material, and

a replacement valve comprising an everting segment;

a delivery device, wherein the expandable anchor and the replacement valve are adapted to be delivered within the delivery device to a vicinity of a heart valve, and wherein the expandable anchor has a delivery configuration within the delivery device; and

a delivery system control element passing through a proximal region of the replacement heart valve when the expandable anchor is in the delivery configuration,

wherein the expandable anchor is axially spaced from the replacement valve when the expandable anchor is in the delivery configuration.

9. The system of claim 8 wherein the system comprises a plurality of delivery system control elements adapted to pass through a proximal region of the replacement heart valve when the expandable anchor is in the delivery configuration.

10. The system of claim 8 wherein the expandable anchor and the replacement valve are coupled to each other.

11. The system of claim 8 wherein the replacement valve is distally spaced from the expandable anchor when the expandable anchor is in the delivery configuration.

12. The system of claim 8 wherein at least a portion of the replacement valve is disposed axially within the expandable anchor when the expandable anchor is in a fully deployed configuration.

13. The system of claim 8 wherein the control element is adapted to pass through a proximal region of the replacement heart valve when the expandable anchor is outside of the delivery device.

14. A system for replacing a heart valve, comprising:

a sheath defining a lumen;

an implantable prosthetic collapsed within said lumen, said implantable prosthetic having;

a replacement valve comprising an everting segment, and

an expandable anchor axially spaced from said replacement valve; and

a first control rod and a second control rod within said lumen, said first control rod and said second control rod reversibly coupled to a proximal end of said expandable anchor.

15. The system of claim 14 further comprising, a first control wire passing through said first control rod and a second control wire passing through said second control rod, said first control wire coupling said first control rod to the proximal end of said expandable anchor, and said second control wire coupling said second control rod to the proximal end of said expandable anchor.

16. The system of claim 15 wherein said first control wire extends through said first control rod, loops through the proximal end of said expandable anchor and extends at least partially back into said first control rod.

17. The system of claim 14 wherein a distal end of said first control rod defines a notch.

18. The system of claim 14 further comprising a valve control wire coupled to said everting segment.

19. The system of claim 14 further comprising a base coupled to a distal end of said expandable anchor;

a post extending proximally from said base; and

a female element within the proximal end of said expandable anchor.

20. The system of claim 19 further comprising a distal region control wire passing through said female element, through said post and back through said female element.