IP Library Granted Patent US 11,571,307
Granted Patent B2
US 11,571,307 · App. 16/939,933 · Granted Feb 7, 2023

Methods, devices, and systems for percutaneously anchoring annuloplasty rings

Inventors: Nadav Yellin (Ramat Gan, IL); Samuel M. Shaolian (Newport Beach, CA); Jeffrey P. Dumontelle (Irvine, CA)
Assignee: VALCARE, INC.
A61F2/2466A61F2/2427A61F2/2448A61F2220/0016
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Quick Facts
Patent No.
US 11,571,307
App. No.
16/939,933
Granted
Feb 7, 2023
Kind
B2
Abstract

Apparatus, systems, and methods are provided for percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves. An annuloplasty ring includes an outer tube, an inner body member, and an anchor deployment system. The outer tube includes a plurality of windows and has an axis along its length. The internal body member includes a plurality of anchors formed perpendicular to the axis. The anchor deployment system selectively rotates the internal body member with respect to the axis of the outer tube. The rotation deploys the plurality of anchors through the plurality of windows.

Claims (29)

1. An annuloplasty device for transcatheter heart valve repair, the annuloplasty device comprising:

an outer tube comprising a plurality of windows, the outer tube including an axis along its length;

an internal body member within the outer tube, the internal body member comprising a plurality of anchors; and

an anchor deployment system to selectively rotate the internal body member about the axis of the outer tube, the rotation deploying the plurality of anchors through the plurality of windows.

2. The annuloplasty device of claim 1 , wherein the anchor deployment system comprises a wire configured to percutaneously rotate the internal body member.

3. The annuloplasty device of claim 1 , wherein the internal body member comprises a hollow passage and one or more tabs extending from a surface of the hollow passage, and wherein the anchor deployment system comprises:

a rotation member configured to be pushed or pulled through the hollow passage of the internal body member by a line connected to the rotation member through a catheter, the rotation member to convert linear movement of the line through the catheter into rotation of the internal body member.

4. The annuloplasty device of claim 3 , wherein the rotation member comprises:

a threaded groove along an outer surface of the rotation member, the threaded groove to engage the one or more tabs and rotate the internal body member as the rotation member is pushed or pulled through the hollow passage.

5. The annuloplasty device of claim 1 , wherein the plurality of anchors comprise a superelastic shape memory material configured to self-propel the anchors into tissue of a heart valve annulus when respective tips of the plurality of anchors are aligned with the plurality of windows.

6. The annuloplasty device of claim 5 , wherein the plurality of anchors comprise:

an introduction configuration for inserting the annuloplasty device through a catheter, wherein the plurality of anchors in the introduction configuration are curved in a first direction so as to be concentric with a surface of the internal body member with respect to the axis; and

a deployed configuration for attaching the annuloplasty device to the tissue of the heart valve annulus, wherein the plurality anchors in the deployed configuration are curved in a second direction that is opposite to the first direction, a transition from the first direction to the second direction increasing a force of the superelastic material for driving the plurality of anchors into the tissue.

7. The annuloplasty device of claim 1 , wherein at least one of the outer tube and the internal body member comprises a superelastic shape memory material configured to change from an elongate insertion geometry to an annular operable geometry, the annuloplasty device configured to pass through a catheter and into a heart chamber in the elongate insertion geometry.

8. The annuloplasty device of claim 1 , wherein at least two of the plurality of windows are aligned on the outer tube to substantially simultaneously deploy at least two corresponding anchors of the plurality of anchors.

9. The annuloplasty device of claim 1 , wherein at least two of the plurality of windows are aligned on the outer tube to selectively deploy at least two corresponding anchors of the plurality of anchors at different times.

10. The annuloplasty device of claim 1 , wherein one or more of the plurality of anchors include a shape selected from a group comprising curved, wavy, straight, and curled.

11. The annuloplasty device of claim 1 , wherein one or more of the plurality of anchors include a pattern cut therein to control at least one of strength and flexibility, the pattern selected from a group comprising a series of rounded rectangular cutouts, a plurality of wavy cutouts, and one or more slots cut along an anchor length.

12. An annuloplasty ring for transcatheter heart valve repair, the annuloplasty ring comprising:

an outer hollow member configured to change from an elongate insertion geometry to an annular operable geometry, the outer hollow member comprising a plurality of windows;

a first internal anchor member located at least partially within the outer hollow member, the first internal anchor member comprising a plurality of first anchors configured to attach the annuloplasty ring to tissue of a heart valve annulus, the first internal anchor member configured to move the plurality of first anchors with respect to corresponding windows of the plurality of windows in the outer hollow member to selectively deploy the plurality of first anchors through the corresponding windows; and

a second internal anchor member located at least partially within the outer hollow member, the second internal anchor member comprising a plurality of second anchors configured to attach the annuloplasty ring to the tissue of the heart valve annulus, the second internal anchor member configured to move the plurality of second anchors with respect to corresponding windows of the plurality of windows in the outer hollow member to selectively deploy the plurality of second anchors through the corresponding windows.

13. The annuloplasty ring of claim 12 , wherein the plurality of first anchors and the plurality of second anchors are configured to deploy at substantially the same time.

14. The annuloplasty ring of claim 12 , wherein the plurality of first anchors and the plurality of second anchors are configured to selectively deploy at different times.

15. The annuloplasty ring of claim 12 , wherein the plurality of first anchors curve in a first direction in a deployed configuration, and the plurality of second anchors curve in a second direction in the deployed configuration, the second direction being different than the first direction.

16. The annuloplasty ring of claim 15 , wherein the plurality of first anchors are each adjacent to a corresponding one of the plurality of second anchors in the deployed configuration.

17. The annuloplasty ring of claim 16 , wherein adjacent anchors deploy through a same window of the plurality of windows.

18. The annuloplasty ring of claim 16 , wherein adjacent anchors deploy through separate, adjacent windows of the plurality of windows.

19. The annuloplasty ring of claim 12 , wherein at least one of the plurality of first anchors and one of the plurality of second anchors include a shape in a deployed configuration selected from a group comprising curved, wavy, straight, and curled.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 8, 2023
From: VALCARE, INC.
To: VALCARE MEDICAL, INC.
Reel/Frame 065835/0401 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 28, 2020
From: YELLIN, NADAV; SHAOLIAN, SAMUEL M.; DUMONTELLE, JEFFREY P.
To: VALCARE, INC.
Reel/Frame 053329/0277 →
Continuity (7)
Continuation 15810936 · Nov 13, 2017
Continuation 14886175 · Oct 19, 2015
Division 13799642 · Mar 13, 2013
Continuation In Part 13779478 · Feb 27, 2013
Provisional Application 61734904 · Dec 7, 2012
Provisional Application 61604856 · Feb 29, 2012
Related Publication 20210085463A1 · Mar 25, 2021
Cited By (6)
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