IP Library Granted Patent US 10,939,997
Granted Patent B2
US 10,939,997 · App. 16/285,566 · Granted Mar 9, 2021

Valve replacement using moveable restraints and angled struts

Inventors: Randall Lashinski (Windsor, CA); Matthew Rust (Windsor, CA); Patrick Macaulay (Windsor, CA); Richard Glenn (Santa Rosa, CA)
Assignee: BOSTON SCIENTIFIC SCIMED, INC.
A61F2/2418A61F2/2409A61F2/2445A61F2/2412A61F2/2433A61F2220/0008A61F2220/0016A61F2230/0069A61F2230/0091A61F2250/001A61F2250/0007
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Quick Facts
Patent No.
US 10,939,997
App. No.
16/285,566
Granted
Mar 9, 2021
Kind
B2
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.

Claims (34)

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.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2020
From: LASHINSKI, RANDALL; RUST, MATTHEW; MACAULAY, PATRICK; GLENN, RICHARD
To: MILLIPEDE, INC.
Reel/Frame 051924/0425 →
NUNC PRO TUNC ASSIGNMENT Recorded Aug 27, 2019
From: MILLIPEDE, INC.
To: BOSTON SCIENTIFIC SCIMED, INC.
Reel/Frame 050188/0738 →
Continuity (4)
Continuation 15829760 · Dec 1, 2017
Continuation 15043301 · Feb 12, 2016
Provisional Application 62116248 · Feb 13, 2015
Related Publication 20190262133A1 · Aug 29, 2019