Everting Heart Valve

• US 20090076598A1
• Filed: 11/12/2008
• Published: 03/19/2009
• 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: Valencia, Hans F., Morejohn, Dwight P., Haug, Ulrich R., Geshlider, Robert A., Michlitsch, Kenneth J., Salahieh, Amr, Saul, Tom
• Granted Patent: US 8,668,733 B2
• Time in Patent Office: Days
• US Class Current: 623/2.110
• 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 comprising a braided material,

a replacement heart valve; and

a delivery device, wherein the expandable anchor and the replacement heart 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,

wherein the expandable anchor is axially spaced from the replacement heart 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 heart valve are coupled to each other.

3. The system of claim 1 wherein the replacement heart 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 heart 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 heart valve is disposed axially within the expandable anchor when the expandable anchor is in the fully deployed configuration.

6. A system for replacing a heart valve, comprising

an expandable anchor having a collapsed delivery configuration and an expanded configuration;

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 seal at least partially disposed around an exterior portion of the expandable anchor when the anchor is in the expanded configuration, wherein the seal is adapted to prevent blood from flowing between the seal and heart tissue,

wherein a distal end of the replacement valve leaflet is attached to the seal.

7. The system of claim 6 wherein the expandable anchor is not attached to the replacement valve leaflet.

8. The system of claim 6 wherein the distal end of the replacement valve leaflet is attached to a distal end of the seal when the expandable anchor is in the expanded configuration.

9. The system of claim 6 wherein the commissure support element is configured to interface with an anchor actuator.

10. The system of claim 9 wherein the anchor actuator is adapted to apply a proximally directed force on the commissure support element to foreshorten the expandable anchor.

11. The system of claim 6 further comprising a lock comprising a first lock element and a second lock element, wherein the first and second lock elements are attached to the expandable anchor and adapted to engage with one another to lock the expandable anchor in the expanded configuration, and

wherein the commissure support element includes the first lock element.

12. The system of claim 11 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 configuration within a delivery catheter.