Valve replacement using moveable restraints and angled struts

Patent metadata

Field	Value
Publication number	US-10939997-B2
Application number	US-201916285566-A
Country	US
Kind code	B2
Filing date	Feb 26, 2019
Priority date	Feb 13, 2015
Publication date	Mar 9, 2021
Grant date	Mar 9, 2021

Abstract

Features for a heart valve device are described. The device may include a frame with anchors configured to secure the device to tissue. The frame may include a flared end or skirt for additional securement of the implanted device. The device may include a seal such as a barrier and/or cuff for preventing leakage. The device may contract for endovascular delivery of the device to the heart and expand for securement within the heart, such as the within the native mitral valve annulus. The device may include a replacement valve. The valve may have leaflets configured to re-direct blood flow along a primary flow axis.

First claim

What is claimed is:

1. An implantable heart valve device comprising:
a frame having a proximal end and a distal end and comprising at least a first pair of adjacent struts, the frame including an anti-backout feature configured to resist movement of the frame within a valve annulus;
a plurality of distally facing anchors carried by and extending distally away from the distal end of the frame in a distal direction and having distally extending ends configured to at least partially embed into tissue surrounding a native valve;
a valve disposed within the frame; and
a moveable restraint coupled with the frame and configured to restrain the frame at a desired configuration.

2. The implantable heart valve device of claim 1 , wherein the frame comprises a proximal end and a distal end, and the anti-backout feature is disposed on the distal end of the frame, the proximal end of the frame, or both.

3. The implantable heart valve device of claim 2 , wherein the anti-backout feature comprises a skirt formed from one of the proximal end or the distal end of the frame.

4. The implantable heart valve device of claim 3 , wherein the frame is disposed about a central axis, and the skirt is angled relative to the central axis of the frame.

5. The implantable heart valve device of claim 4 , wherein the skirt is formed from the distal end of the frame and angled upwards towards the proximal end of the frame.

6. The implantable heart valve device of claim 4 , wherein the skirt is formed from the proximal end of the frame and angled towards the distal end of the frame.

7. The implantable heart valve device of claim 4 , wherein the skirt supports the distally facing anchors and angularly displaces the distally facing anchors relative to the central axis of the frame.

8. The implantable heart valve device of claim 7 , wherein the skirt is configured to provide different angular displacements from the central axis for at least two of the distally facing anchors.

9. The implantable heart valve device of claim 3 , wherein the frame is comprised of a plurality of struts joined in pairs to form a plurality of vertices, and wherein the skirt is formed from the plurality of vertices.

10. The implantable heart valve device of claim 1 , wherein the plurality of distally facing anchors are rotatably carried by the frame.

11. The implantable heart valve device of claim 1 , wherein the frame is disposed about a central axis, and the anti-backout feature is formed from a material that expands during deployment of the frame to change an angular displacement between the anti-backout feature and the central axis of the frame.

12. An implant device comprising:
a frame having a proximal end and a distal end, the frame comprised of a plurality of adjacent struts joined to provide proximal apices and distal apices, the frame including an anti-backout feature configured to resist movement of the frame within a valve annulus;
a plurality of anchors coupled to the anti-backout feature of the frame and having distal ends extending distally away from the distal end of the frame in a distal direction and configured to engage tissue; and
at least one moveable restraint coupled to at least one proximal apex of the frame and configured to restrain the frame to a contracted configuration.

13. The implant device of claim 12 , wherein the anti-backout feature is formed on the distal end of the frame, the proximal end of the frame, or both.

14. The implant device of claim 12 , wherein the anti-backout feature comprises a skirt formed from one of the proximal apices or the distal apices of the frame.

15. The implant device of claim 14 , wherein the frame is disposed about a central axis, and the skirt is angled relative to the central axis of the frame.

16. The implant device of claim 15 , wherein the skirt is formed from the distal end of the frame and angled upwards towards the proximal end of the frame.

17. The implant device of claim 15 , wherein the skirt supports the distally facing anchors and angularly displaces the distally facing anchors relative to the central axis of the frame.

18. The implant device of claim 17 , wherein the skirt is angularly displaced to different extents around a circumference of the frame to provide different angular displacements for the distally facing anchors.

19. The implant device of claim 12 , wherein the frame is disposed about a central axis, and the anti-backout feature is formed from a material that expands during deployment of the frame to change an angular displacement between the anti-backout feature and the central axis of the frame.

20. A method comprising:
deploying a distal end of a delivery catheter to a native valve, the distal end of the delivery catheter carrying an implant comprising:
a frame comprising a proximal end and a distal end, the frame comprised of a plurality of adjacent struts joined to provide proximal and distal apices, the frame including an anti-backout feature configured to resist movement of the frame within a valve annulus;
a plurality of distally facing anchors extending distally away from the distal end of the frame in a distal direction, at least some of the distally facing anchors carried by the anti-backout feature of the frame and having distally extending ends configured to engage tissue;
a valve, disposed within the frame; and
at least one moveable restraint coupled to at least one proximal apex of the frame and configured to restrain the frame to a contracted configuration;

positioning the implant within the native valve, causing the anti-backout feature to expand within the native valve to secure the implant within a native valve annulus; and
driving the plurality of distally facing anchors into the native valve annulus to retain the valve within the native valve annulus.

Assignees

• Millipede Inc
• Boston Scient Scimed Inc

Inventors

• Lashinski Randall
• Rust Matthew
• Macaulay Patrick
• Glenn Richard

Classifications

• A61F2/2445

  Annuloplasty rings in direct contact with the valve annulus · CPC title

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2/2463

  Implants forming part of the valve leaflets · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2250/0007

  for adjusting length · CPC title