Vascular implant and delivery system

• US 9,339,379 B2
• Filed: 01/31/2013
• Issued: 05/17/2016
• 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:
  US13/755,863
• Publication Number:
  US 20130138207A1
• Time in Patent Office: 1,202 Days
• 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 valve configured to be delivered to a native mitral valve and secured relative to a native mitral valve annulus, the native mitral valve positioned between a left atrium and a left ventricle, the replacement mitral valve comprising:

an expandable frame comprising a proximal end and a distal end and having a longitudinal axis extending between the proximal end and the distal end, the expandable frame configured to radially expand and contract for deployment within the native mitral valve;

a first anchoring portion configured to at least partially engage an atrial side of the native mitral valve annulus, the first anchoring portion comprising a plurality of circumferentially-spaced tips connected by at least one row of circumferentially expansible elements extending continuously around the first anchoring portion, wherein when the expandable frame is in an expanded configuration, the first anchoring portion extends radially outwardly from a portion of the expandable frame that has a first cross-sectional dimension such that the at least one row of circumferentially expansible elements has a second cross-sectional dimension greater than the first cross-sectional dimension;

a second anchoring portion distal to the first anchoring portion and comprising a plurality of anchors extending from the expandable frame configured for placement on a ventricular side of the native mitral valve annulus, wherein when the expandable frame is in an expanded configuration, the plurality of anchors extend at least partially proximally toward the first anchoring portion; and

a valve body connected to the expandable frame;

wherein radial expansion of the expandable frame causes the first anchoring portion and the second anchoring portion to draw closer together; and

wherein, when the expandable frame is in the expanded configuration, tips of the plurality of anchors of the second anchoring portion extend to a third cross-sectional dimension which is at least about the same as the second cross-sectional dimension.

2. The replacement mitral valve of claim 1, wherein the plurality of anchoring tips of the first anchoring portion extend radially outward when the expandable frame is in an expanded configuration.

3. The replacement mitral valve of claim 1, wherein the plurality of tips of the first anchoring portion extend generally distally when the expandable frame is in an expanded configuration.

4. The replacement mitral valve of claim 1, wherein the first anchoring portion extends radially outwardly from the portion of the expandable frame having the first cross-sectional dimension in a direction generally perpendicular to the longitudinal axis.

5. The replacement mitral valve of claim 1, wherein when the expandable frame is in an expanded configuration, the expandable frame has a substantially constant outer diameter from where the plurality of anchors of the second anchoring portion connect to the expandable frame to where the first anchoring portion extends radially outwardly from the portion of the expandable frame having the first cross-sectional dimension.

6. The replacement mitral valve of claim 1, wherein the plurality of anchors of the second anchoring portion extend from a foreshortening portion of the expandable frame.

7. The replacement mitral valve of claim 1, wherein the first anchoring portion comprises a non-foreshortening portion that does not substantially foreshorten when the expandable frame radially expands.

8. The replacement mitral valve of claim 1, wherein when the expandable frame is in an expanded configuration, the plurality of anchors of the second anchoring portion extend substantially parallel to the longitudinal axis of the expandable frame toward the first anchoring portion.

9. The replacement mitral valve of claim 1, wherein when the expandable frame is in an expanded configuration, the plurality of anchors of the second anchoring portion extend distally away from the distal end of the expandable frame and then extend proximally toward the proximal end of the expandable frame.

10. The replacement mitral valve of claim 1, wherein the plurality of anchors of the second anchoring portion are atraumatic.

11. The replacement mitral valve of claim 1, wherein the at least one row of circumferentially expansible elements are arranged in a zig-zag pattern.

12. The replacement mitral valve of claim 1, wherein the replacement mitral valve is shaped such that, after the replacement mitral valve has been delivered to the native mitral valve and expanded, at least a portion of the first anchoring portion contacts tissue on the atrial side of the native mitral valve annulus and at least a portion of the second anchoring portion contacts tissue on the ventricular side of the native mitral valve annulus.

13. The replacement mitral valve of claim 1, wherein the expandable frame comprises a D-shaped cross-section.

14. A replacement mitral valve configured to be delivered to a native mitral valve and secured relative to a native mitral valve annulus, the native mitral valve positioned between a left atrium and a left ventricle, the replacement mitral valve comprising:

an expandable frame extending along a longitudinal axis between a first end and a second end, the expandable frame comprising a first portion and a second portion, the first portion being closer to the first end than the second portion is to the first end, and the second portion being closer to the second end than the first portion is to the second end, wherein the second portion comprises a plurality of foreshortening cells and the first portion comprises a plurality of struts having at least a portion thereof extending longitudinally from foreshortening cells of the second portion toward the first end of the expandable frame, wherein the first portion comprises a non-foreshortening portion that does not substantially foreshorten when the expandable frame is radially expanded;

a plurality of anchors connected to the second portion of the expandable frame, wherein the plurality of anchors extend radially outward from the expandable frame and extend in a direction generally toward the first end when the expandable frame is in an expanded configuration; and

a valve body attached to the expandable frame;

wherein when the expandable frame is in an expanded configuration, the first portion comprises an anchoring portion configured to engage an atrial side of the native mitral valve annulus that extends radially outwardly from the second portion in a direction generally perpendicular to the longitudinal axis, and

wherein the replacement mitral valve is shaped such that, after the replacement mitral valve has been delivered to the native mitral valve and expanded, at least a portion of the anchoring portion 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.

15. The replacement mitral valve of claim 14, wherein the first portion comprises a plurality of anchoring tips configured to engage the valve on an atrial side of the native mitral valve annulus when the expandable frame is in an expanded configuration.

16. The replacement mitral valve of claim 14, wherein the first portion comprises at least one row of circumferentially expansible elements, and wherein the struts extend transversely across the at least one row.

17. The replacement mitral valve of claim 14, wherein the plurality of anchors are atraumatic.

18. The replacement mitral valve of claim 14, wherein when the expandable frame is in an expanded configuration, each of the struts lies in a plane parallel to and intersecting the longitudinal axis.

19. The replacement mitral valve of claim 14, wherein when the expandable frame is in an expanded configuration, the first portion of the expandable frame has a cross-sectional dimension greater than a cross-sectional dimension of the second portion of the expandable frame.

20. A replacement mitral valve configured to be delivered to a native mitral valve and secured relative to a native mitral valve annulus, the native mitral valve positioned between a left atrium and a left ventricle, the replacement mitral valve comprising:

an expandable frame comprising a proximal end and a distal end and having a longitudinal axis extending between the proximal end and the distal end, the expandable frame configured to radially expand and contract for deployment within the native mitral valve;

a first anchoring portion sized to at least partially engage an atrial side of the native mitral valve annulus, wherein when the expandable frame is in an expanded configuration;

a first section of the first anchoring portion extends radially outwardly of the longitudinal axis and at least partially proximally; and

a second section of the first anchoring portion proximal to the first section extends radially inwardly from the first section towards the longitudinal axis and at least partially proximally;

a second anchoring portion distal to the first anchoring portion and comprising a plurality of anchors extending from the expandable frame sized for placement on a ventricular side of the native mitral valve annulus, wherein when the expandable frame is in an expanded configuration, the plurality of anchors extend at least partially proximally toward the first anchoring portion; and

a valve body connected to the expandable frame.

21. The replacement mitral valve of claim 20, wherein the replacement mitral valve is shaped such that, after the replacement mitral valve has been delivered to the native mitral valve and expanded, at least a portion of the first anchoring portion contacts tissue on the atrial side of the native mitral valve annulus and at least a portion of the second anchoring portion contacts tissue on the ventricular side of the native mitral valve annulus.

22. The replacement mitral valve of claim 21, wherein the replacement mitral valve is shaped such that, after the replacement mitral valve has been delivered to the native mitral valve and expanded, at least a portion of the second anchoring portion contacts at least one of the native mitral valve annulus and leaflets of the native mitral valve.

23. The replacement mitral valve of claim 21, wherein the replacement mitral valve is shaped such that, after the replacement mitral valve has been delivered to the native mitral valve and expanded, the expandable frame comprises a cylindrical portion extending within a chamber of the heart with at least a portion of the valve body positioned within the cylindrical portion such that the valve body is located substantially outside of the native valve annulus.

24. The replacement mitral valve of claim 20, wherein the first section of the first anchoring portion extends radially outwardly to define a shoulder.

25. The replacement mitral valve of claim 20, wherein when the expandable frame is in an expanded configuration, the expandable frame has a substantially constant outer diameter from where the plurality of anchors of the second anchoring portion connect to the expandable frame to where the first section of the first anchoring portion extends radially outwardly of the longitudinal axis.

26. The replacement mitral valve of claim 20, wherein when the expandable frame is in an expanded configuration, the second section of the first anchoring portion, after extending radially inwardly from the first section towards the longitudinal axis and at least partially proximally, extends in a direction generally parallel to the longitudinal axis.

27. The replacement mitral valve of claim 20, wherein when the expandable frame is in an expanded configuration, a cross-sectional dimension of the proximal end of the expandable frame is less than a cross-sectional dimension of the second anchoring portion.

28. The replacement mitral valve of claim 20, wherein when the expandable frame is in an expanded configuration, a cross-sectional dimension of the proximal end of the expandable frame is about the same as a cross-sectional dimension of the distal end of the expandable frame.

29. The replacement mitral valve of claim 20, wherein when the frame is in an expanded configuration, the expandable frame comprises a cylindrical portion which extends away from both the first and second anchoring portions towards one of the ends of the frame, wherein at least a portion of the valve body is positioned within the cylindrical portion when the expandable frame is in an expanded configuration.