Vascular implant

• US 9,585,747 B2
• Filed: 06/24/2014
• Issued: 03/07/2017
• Est. Priority Date: 04/15/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Primary Examiner(s): Anderson, Gregory
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US14/313,160
• Publication Number:
  US 20140309731A1
• Time in Patent Office: 987 Days
• Field of Search: 623 111- 112, 623/1.15, 623/1.23, 623/2.1, 623 211- 219
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0805 Implements for inserting tendons or ligaments
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2002/0882 Anchor in or on top of a bone tunnel, i.e. a hole running through the entire bone
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/001 for adjusting a diameter

Abstract

A vascular implant for replacing a native heart valve comprises a self expanding stent supporting a valve body having leaflets. The stent preferably comprises an anchoring structure configured to prevent the implant from passing through the valve annulus. For delivery, the implant is compacted within a delivery device and secured at one end. During delivery the implant is partially released from the delivery device, and positioning of the implant can be verified prior to full release. The implant can be at least partially resheathed and repositioned if desired.

Claims

1. A replacement mitral heart valve comprising:

an expandable frame comprising a first portion configured to be positioned in the left atrium of the heart and a second portion configured to be positioned inside of the native mitral valve annulus, wherein the frame comprises a D-shaped cross-section to facilitate engagement with the native mitral valve annulus;

a plurality of anchors extending from the frame, wherein the plurality of anchors are sized to contact a native mitral valve on a ventricular side of the native mitral valve annulus, wherein each of the plurality of anchors extends generally toward the first portion of the frame when the frame is in an expanded configuration, and wherein the plurality of anchors are approximately equally spaced around an entire perimeter of the frame; and

a valve body attached to the frame;

wherein the first portion comprises an anchoring feature configured to contact the native mitral valve on an atrial side of the native mitral valve annulus; and

wherein the replacement mitral heart valve is configured such that, after the replacement mitral heart valve has been delivered to a native mitral valve and expanded, the anchoring feature contacts tissue on the atrial side of the native mitral valve annulus and at least some of the plurality of anchors contact tissue on the ventricular side of the native mitral valve annulus.

2. The replacement mitral heart valve of claim 1, wherein the frame further comprises a third portion configured to be positioned in the left ventricle of the heart, wherein the plurality of anchors extend from the third portion of the frame.

3. The replacement mitral heart valve of claim 2, wherein the plurality of anchors extend radially outward from the third portion of the frame and in a direction substantially parallel with a longitudinal axis of the frame.

4. The replacement mitral heart valve of claim 1, wherein the plurality of anchors comprise tips having a smooth radius.

5. The replacement mitral heart valve of claim 1, further comprising eyelets on at least some of the plurality of anchors.

6. The replacement mitral heart valve of claim 1, wherein a portion of the frame is flared to provide the anchoring feature.

7. The replacement mitral heart valve of claim 1, wherein the anchoring feature is a shoulder.

8. The replacement mitral heart valve of claim 1, wherein the anchoring feature comprises a plurality of outwardly extending anchoring features.

9. The replacement mitral heart valve of claim 1, further comprising a liner covering at least part of the frame.

10. The replacement mitral heart valve of claim 9, wherein the liner extends along at least the second portion of the frame.

11. The replacement mitral heart valve of claim 9, wherein the liner covers at least part of the plurality of anchors.

12. The replacement mitral heart valve of claim 1, wherein the frame is made of a self-expanding material.

13. The replacement mitral heart valve of claim 1, wherein the frame comprises a plurality of diamond-shaped cells.

14. The replacement mitral heart valve of claim 13, wherein each of the plurality of anchors extends from one of the diamond-shaped cells.

15. The replacement mitral heart valve of claim 1, wherein the valve body comprises three leaflets.

16. The replacement mitral heart valve of claim 1, further comprising locking features provided on the first portion of the frame to engage with mating features of a delivery device.

17. The replacement mitral heart valve of claim 1, wherein a proximalmost portion of the plurality of anchors are proximal to where the plurality of anchors connect to the frame.

18. A replacement mitral heart valve comprising:

an expandable frame comprising a first portion configured to be positioned in the left atrium of the heart and a second portion configured to be positioned inside of the native mitral valve annulus, wherein the frame comprises a D-shaped cross-section to facilitate engagement with the native mitral valve annulus;

a plurality of anchors extending from the frame, wherein each of the plurality of anchors extends generally toward the first portion of the frame when the frame is in an expanded configuration, and wherein at least one anchor of the plurality of anchors extends towards an anterior side of the native mitral valve; and

a valve body attached to the frame;

wherein the first portion comprises an anchoring feature configured to contact the native mitral valve on an atrial side of the native mitral valve annulus; and

wherein the replacement mitral heart valve is configured such that, after the replacement mitral heart valve has been delivered to a native mitral valve and expanded, the anchoring feature contacts tissue on the atrial side of the native mitral valve annulus and at least some of the plurality of anchors contact tissue on the ventricular side of the native mitral valve annulus.

19. The replacement mitral heart valve of claim 18, wherein the at least one anchor which extends towards an anterior side of the native mitral valve includes an end which extends in a direction substantially parallel with a longitudinal axis of the frame.

20. A replacement mitral heart valve comprising:

an expandable frame comprising a first portion configured to be positioned in the left atrium of the heart and a second portion configured to be positioned inside of the native mitral valve annulus;

a plurality of anchors extending from the frame, wherein tips of each of the plurality of anchors extend generally parallel to a longitudinal axis of the frame when the frame is in an expanded configuration; and

a valve body attached to the frame, wherein the valve body is configured such that, after the replacement mitral heart valve has been delivered to a native mitral valve and expanded, the valve body is primarily positioned within the left atrium of the heart;

wherein the first portion comprises an anchoring feature configured to be positioned on an atrial side of the native mitral valve annulus, and

wherein the replacement mitral heart valve is configured such that, after the replacement mitral heart valve has been delivered to a native mitral valve and expanded, at least one tip of the plurality of anchors is configured to exert a force on the native mitral valve annulus in a direction generally parallel to a longitudinal axis of the expandable frame.

21. The replacement heart valve of claim 20, further comprising a liner which extends radially outward from the longitudinal axis of the frame when the frame is in the expanded configuration, the liner sized to engage the atrial side of the native mitral valve annulus.

22. The replacement mitral heart valve of claim 20, wherein the anchoring feature comprises a plurality of ends which are circumferentially offset from tips of the plurality of anchors.

23. The replacement mitral heart valve of claim 20, wherein the anchoring feature comprises a plurality of ends which extend distally from a row of circumferentially expansible elements extending continuously around the first portion, the circumferentially expansible elements being connected to a plurality of generally longitudinally extending struts.