Vascular implant

• US 9,339,380 B2
• Filed: 02/21/2014
• 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:
  US14/186,989
• Publication Number:
  US 20140172086A1
• Time in Patent Office: 816 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 for delivery to a native mitral valve to be 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 a longitudinal axis extending therethrough, the frame shaped to radially expand and collapse for deployment within the native mitral valve annulus;

a plurality of proximal anchors connected to the frame and sized to contact the native mitral valve on an atrial side of the native mitral valve annulus, wherein when the frame is in an expanded configuration within the native mitral valve annulus, the plurality of proximal anchors extend radially outward on the atrial side of the native mitral valve annulus and extend at least partially distally;

a plurality of distal anchors connected to the frame and sized to contact the native mitral valve on a ventricular side of the native mitral valve annulus, wherein when the frame is in an expanded configuration within the native mitral valve annulus;

each distal anchor extends at least partially distally away from the distal end of the frame and then extends at least partially proximally toward the proximal end of the frame;

a proximalmost portion of each distal anchor is positioned radially outward from the frame; and

the proximalmost portions of the distal anchors are proximal to where the distal anchors connect to the frame; and

a valve body attached to the expandable frame;

wherein radial expansion of the frame causes the plurality of distal anchors to draw closer to the plurality of proximal anchors; 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 some of the plurality of proximal anchors contact tissue on the atrial side of the native mitral valve annulus and at least some of the plurality of distal anchors contact tissue on the ventricular side of the native mitral valve annulus.

2. The replacement mitral valve of claim 1, wherein the proximalmost portions of the distal anchors extend substantially parallel with the longitudinal axis.

3. The replacement mitral valve of claim 1, wherein at least a portion of the distal anchors are covered with a fabric.

4. The replacement mitral valve of claim 1, wherein the plurality of proximal anchors extend from a portion of the frame that does not substantially foreshorten when the frame radially expands.

5. The replacement mitral valve of claim 1, wherein the plurality of distal anchors extend from a portion of the frame that substantially foreshortens when the frame radially expands.

6. The replacement mitral valve of claim 1, wherein the proximalmost portions of the plurality of distal anchors are atraumatic.

7. The replacement mitral valve of claim 1, wherein the frame comprises a plurality of foreshortening cells each having a proximalmost end, a distalmost end and a midpoint between the proximalmost and distalmost ends, wherein the distal anchors extend proximally past the midpoint of a foreshortening cell of the plurality of foreshortening cells.

8. The replacement mitral valve of claim 1, wherein the distal anchors comprise a first length extending distally and a second length extending proximally, wherein the first length does not extend radially outward.

9. A replacement mitral valve for delivery to a native mitral valve to be 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 a longitudinal axis extending therethrough, the frame shaped to radially expand and collapse for deployment within the native mitral valve annulus;

a plurality of proximal anchors each connected to the frame so that when the frame is in an expanded configuration, outermost ends of the proximal anchors are positioned radially outward from a portion of the frame; and

a plurality of distal anchors each connected to the frame so that when the frame is in an expanded configuration, the distal anchors have outermost ends that are positioned radially outward from a portion of the frame and the distal anchors extend generally proximally so that the outermost ends of the distal anchors are proximal to where the distal anchors connect to the frame; and

a valve body attached to the expandable frame;

wherein the outermost ends of the proximal anchors are not circumferentially aligned with the outermost ends of the distal anchors when the frame is in an expanded configuration; and

wherein the frame is shaped such that radial expansion of the frame causes the proximal anchors and the distal anchors to draw closer together;

wherein the proximal and distal anchors are arranged along a circumference of the replacement mitral valve such that, when the frame is in the expanded configuration within the native mitral valve annulus, at least some of the plurality of proximal anchors contact tissue on an atrial side of the native mitral valve annulus and at least some of the plurality of distal anchors contact tissue on a ventricular side of the native mitral valve annulus.

10. The replacement mitral valve of claim 9, wherein the outermost ends of the plurality of distal anchors are atraumatic.

11. The replacement mitral valve of claim 9, wherein when the frame is in an expanded configuration, the distal anchors extend generally distally away from the distal end of the frame and then extend generally proximally toward the proximal end of the frame.

12. The replacement mitral valve of claim 9, wherein the distal anchors comprise anchoring portions that extend substantially parallel to the longitudinal axis when the frame is in an expanded configuration.

13. The replacement mitral valve of claim 9, wherein when the frame is in an expanded configuration, the proximal anchors extend generally distally so that the outermost ends of the proximal anchors are distal to where the proximal anchors connect to the frame.

14. The replacement mitral valve of claim 9, wherein the proximal anchors extend distally from the frame substantially parallel to the longitudinal axis when the frame is in an expanded configuration.

15. The replacement mitral valve of claim 9, wherein the frame comprises a foreshortening portion that substantially foreshortens when the frame radially expands.

16. The replacement mitral valve of claim 15, wherein the distal anchors are connected to the foreshortening portion.

17. The replacement mitral valve of claim 9, wherein the frame comprises a non-foreshortening portion that does not substantially foreshorten when the frame radially expands.

18. The replacement mitral valve of claim 17, wherein the proximal anchors extend from the non-foreshortening portion of the frame.

19. The replacement mitral valve of claim 9, wherein the plurality of proximal anchors are sized to contact the native mitral valve on an atrial side of the native mitral valve annulus and the plurality of distal anchors are sized to contact the native mitral valve on a ventricular side of the native mitral valve annulus.