Vascular implant

• US 8,795,356 B2
• Filed: 02/21/2014
• Issued: 08/05/2014
• Est. Priority Date: 04/15/2009
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Quadri, Arshad, Ratz, J. Brent
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): DANG, PHONG SON H
• Application Number:
  US14/186,957
• Publication Number:
  US 20140172085A1
• Time in Patent Office: 165 Days
• US Class Current: 623/2.11
• 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 extending along a longitudinal axis between a first end and a second end, the 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 frame;

wherein the first portion comprises a non-foreshortening portion that does not substantially foreshorten when the frame is radially expanded;

a first plurality of anchors connected to the first portion of the frame, wherein the first plurality of anchors are positioned radially outward from a portion of the frame when the frame is in an expanded configuration;

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

a valve body attached to the expandable frame;

wherein radial expansion of the frame causes the plurality of first plurality of anchors and the second plurality of anchors to draw closer together.

2. The replacement mitral valve of claim 1, wherein the first portion comprises an anchoring portion that extends radially outwardly from the second portion to position the first plurality of anchors radially outward from a portion of the frame when the frame is in an expanded configuration.

3. The replacement mitral valve of claim 2, wherein the first portion comprises an anchoring portion that extends radially outwardly from the second portion in a direction generally perpendicular to the longitudinal axis.

4. The replacement mitral valve of claim 1, wherein when the frame is in an expanded configuration, the first plurality of anchors extend radially outward from the frame.

5. The replacement mitral valve of claim 1, wherein when the frame is in an expanded configuration, the first plurality of anchors extend in a direction generally toward the second end of the frame.

6. The replacement mitral valve of claim 1, wherein each of the first plurality of anchors is connected to the frame at a junction between a strut and a foreshortening cell.

7. The replacement mitral valve of claim 1, wherein each of the first plurality of anchors is connected to the frame at a location of the first portion of the frame spaced away from a junction between a strut and a foreshortening cell.

8. The replacement mitral valve of claim 1, wherein when the frame is in an expanded configuration, the second plurality of anchors extend toward the first end of the frame to outermost portions that are spaced radially outward from an outer surface of the frame.

9. The replacement mitral valve of claim 8, wherein when the frame is in an expanded configuration, the outermost portions of the second plurality of anchors extend substantially parallel to the longitudinal axis of the frame.

10. The replacement mitral valve of claim 8, wherein the outermost portions of the second plurality of anchors are atraumatic.

11. The replacement mitral valve of claim 1, wherein when the frame is in an expanded configuration, the second plurality of anchors extend generally longitudinally away from the first and second ends of the frame before bending to extend generally longitudinally toward the first end of the frame.

12. The replacement mitral valve of claim 1, 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.

13. The replacement mitral valve of claim 12, wherein first plurality of anchors extend from the circumferentially expansible elements.

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 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 frame;

wherein the first portion comprises a non-foreshortening portion that does not substantially foreshorten when the frame is radially expanded;

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

a valve body attached to the expandable frame;

wherein when the 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 radial expansion of the frame causes the plurality of first plurality of anchors and the second plurality of anchors to draw closer together.

15. The replacement mitral valve of claim 14, wherein the first portion comprises a plurality of anchoring tips configured to engage an atrial side of the native mitral valve annulus when the 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, when the frame is in an expanded configuration, each of the struts lies in a plane parallel to and intersecting the longitudinal axis.