Everting heart valve

• US 8,992,608 B2
• Filed: 06/26/2009
• Issued: 03/31/2015
• Est. Priority Date: 06/16/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (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:
  US12/492,512
• Publication Number:
  US 20090264997A1
• Time in Patent Office: 2,104 Days
• Field of Search: 623 111- 154
• US Class Current: 623/2.38
• 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:

an expandable anchor having a collapsed delivery configuration and an expanded configuration, the expandable anchor comprising a distal end;

a replacement valve commissure support element attached to the expandable anchor;

a commissure portion of a replacement valve leaflet attached to the commissure support element; and

a fabric seal at least partially disposed around an exterior portion of the expandable anchor when the anchor is in the expanded configuration, the fabric seal having an undeployed state and a deployed state, wherein in the deployed state the fabric seal comprises flaps that extend into spaces formed by native valve leaflets;

wherein a distal end of the replacement valve leaflet is attached to the fabric seal and when the expandable anchor is in the collapsed delivery configuration, the fabric seal extends from the distal end of the replacement valve and back proximally over the expandable anchor, the fabric seal being adapted to prevent blood from flowing between the fabric seal and heart tissue.

2. The system of claim 1, wherein, in the deployed state, the fabric seal defines a plurality of pockets.

3. The system of claim 2, wherein the pockets are adapted to fill with blood in response to backflow blood pressure.

4. The system of claim 1, wherein the expandable anchor is formed from stainless steel or nickel-titanium alloy.

5. The system of claim 1, wherein the commissure support element is configured to interface with an anchor actuator.

6. The system of claim 5, wherein the anchor actuator is adapted to apply a proximally directed force on the commissure support element to foreshorten the expandable anchor.

7. The system of claim 1 further comprising a lock having a first lock element and a second lock element, the first and second lock elements being attached to the expandable anchor and configured to interlockingly engage one another to lock the expandable anchor in the expanded configuration.

8. The system of claim 7, wherein the commissure support element includes the first lock element.

9. The system of claim 8, wherein the second lock element is attached to the expandable anchor and is disposed proximal to the first lock element when the expandable anchor is in the collapsed delivery configuration.