Vascular implant and delivery system

• US 9,333,074 B2
• Filed: 01/16/2015
• Issued: 05/10/2016
• 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:
  US14/598,568
• Publication Number:
  US 20150209137A1
• Time in Patent Office: 480 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 delivery system configured to deliver a replacement valve to a native mitral valve and secure the replacement valve relative to a native mitral valve annulus, the native mitral valve positioned between a left atrium and a left ventricle, the delivery system comprising:

a delivery device comprising;

an elongate inner tube having a proximal end and a distal end;

a nose cone positioned at or adjacent the distal end of the elongate inner tube;

a support tube having a proximal end and a distal end, the support tube being positioned over the elongate inner tube;

a locking mechanism positioned at or adjacent the distal end of the support tube, the locking mechanism comprising;

a capture slot configured to engage one or more locking members of the replacement valve; and

one or more guide slots configured to receive a portion of the replacement valve when the one or more locking members is engaged with the capture slot, the capture slot being proximal to the one or more guide slots; and

a first sheath configured to cover at least the capture slot when the one or more locking members of the replacement valve is engaged with the capture slot;

wherein the one or more locking members is configured to be disposed between the first sheath and a surface of the capture slot; and

wherein the first sheath and support tube are configured to be moveable relative to each other.

2. The delivery system of claim 1, wherein the first sheath is configured to be moved proximally over the support tube to release the one or more locking members from the capture slot.

3. The delivery system of claim 1, wherein the support tube is slidably disposed over the elongate inner tube.

4. The delivery system of claim 1, wherein the capture slot extends circumferentially around the locking mechanism.

5. The delivery system of claim 1, further comprising a second sheath, the first sheath positioned within the second sheath and being moveable relative to the second sheath.

6. The delivery system of claim 1, further comprising a replacement valve, the replacement valve comprising:

an expandable frame having a proximal end and a distal end;

a first plurality of anchors connected to the expandable frame configured to engage the native mitral valve on a left ventricular side of the native mitral valve annulus;

a valve body attached to the expandable frame; and

the one or more locking members.

7. The delivery system of claim 6, wherein the replacement valve further comprises a second plurality of anchors connected to the expandable frame configured to engage the native mitral valve on a left atrial side of the native mitral valve annulus.

8. The delivery system of claim 6, wherein the replacement valve further comprises one or more longitudinally extending members, and wherein the one or more locking members is positioned at proximal ends of the one or more longitudinally extending members.

9. The delivery system of claim 6, wherein the one or more locking members is at a non-anchoring portion of the replacement valve.

10. The delivery system of claim 6, wherein the one or more locking members is separate from any anchors of the replacement valve.

11. The delivery system of claim 6, wherein the one or more locking members has a shape that is enlarged relative to an adjacent portion of the expandable frame.

12. The delivery system of claim 11, wherein each of the locking members has an arrowhead-type shape with a rounded end.

13. The delivery system of claim 6, wherein the first plurality of anchors are disposed radially outward from a distal portion of an outer surface of the first sheath when the expandable frame is in a radially compacted position within the first sheath.

14. The delivery system of claim 13, wherein the first plurality of anchors are positioned between the first sheath and a second sheath of the delivery device when the expandable frame is in a radially compacted position within the delivery device.