Everting heart valve

• US 9,744,035 B2
• Filed: 10/02/2015
• Issued: 08/29/2017
• Est. Priority Date: 06/16/2004
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Salahieh, Amr, Haug, Ulrich R., Valencia, Hans F., Geshlider, Robert A., Saul, Tom, Morejohn, Dwight P., Michlitsch, Kenneth J.
• Primary Examiner(s): Schillinger, Ann
• Application Number:
  US14/873,462
• Publication Number:
  US 20160022418A1
• Time in Patent Office: 697 Days
• 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 medical device, comprising:

a tubular anchor member reversibly actuatable between a delivery configuration and a deployed configuration; and

an everting replacement valve including a plurality of valve leaflets and an everting segment configured to translate relative to the tubular anchor member;

wherein the everting segment is disposed within the tubular anchor member when the tubular anchor member is in the delivery configuration and the everting segment is disposed at least partially outside of the tubular anchor member when the tubular anchor member is in the deployed configuration.

2. The medical device of claim 1, wherein the everting segment is disposed about a distal end of the tubular anchor member when the tubular anchor member is in the deployed configuration.

3. The medical device of claim 2, wherein the everting segment is wrapped around the distal end of the tubular anchor member during deployment.

4. The medical device of claim 1, wherein the everting segment is a sealing element between the replacement valve and a patient'"'"'s native valve.

5. The medical device of claim 1, wherein the everting segment is pulled distally out of the tubular anchor member when the tubular anchor member is translated from the delivery configuration to the deployed configuration.

6. The medical device of claim 1, further comprising a delivery system including a sheath and one or more control wires releasably coupled to the everting segment, the one or more control wires extending through a lumen of the sheath.

7. The medical device of claim 6, wherein the tubular anchor member and the replacement valve are disposed within the sheath when the tubular anchor member is in the delivery configuration.

8. The medical device of claim 6, wherein tension applied at a proximal end of the one or more control wires pulls the everting segment distally out of the tubular anchor member.

9. The medical device of claim 8, wherein tension applied at the proximal end of the one or more control wires further pulls the everting segment around a distal end of the tubular anchor member and proximally along an outer surface thereof.