METHODS, DEVICES, AND SYSTEMS FOR PERCUTANEOUSLY ANCHORING ANNULOPLASTY RINGS

• US 20130226290A1
• Filed: 03/13/2013
• Published: 08/29/2013
• Est. Priority Date: 02/29/2012
• Status: Active Grant

• Current Assignee: ValCare Medical, Inc.
• Original Assignee: ValCare, Inc.
• Inventors: Yellin, Nadav, Shaolian, Samuel M., DuMontelle, Jeffrey P.
• Granted Patent: US 9,180,008 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

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

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 with respect to 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 device for transcatheter heart valve repair, the annuloplasty device comprising:

a tubular body member comprising shape memory material, the tubular body member including a plurality of anchors cut therein, each of the plurality of anchors cut along a circumference of the tubular body member such that, in an introduction configuration, the anchors are in a radial plane of the tubular body member and are concentric with the tubular body member, the plurality of anchors heat treated to a deployed configuration that extends from the radial plane of the tubular body member;

a retaining ribbon to hold the plurality of anchors in the introduction configuration and to selectively release the plurality of anchors to the deployed configuration; and

one or more retainer features extending from an outer surface of the tubular body member, the one or more retainer features to hold the retaining ribbon against the outer surface of tubular body member and the plurality of anchors in introduction configuration, and the one or more retainer features allowing the retaining ribbon to slide along the surface of the tubular body member to selectively release one or more of the plurality of anchors.

13. The annuloplasty device of claim 12, wherein the plurality anchors in the deployed configuration are curved in an opposite direction from that of the radial plane of the tubular body member such that a transition from the introduction configuration to the deployed configuration increases a force of a superelastic property of the shape memory material to drive the plurality of anchors into tissue of a heart valve annulus.

14. The annuloplasty device of claim 12, wherein the tubular body member is 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 and to be anchored to a heart valve annulus in the annular operable geometry.

15. 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.

16. The annuloplasty ring of claim 15, wherein the plurality of first anchors and the plurality of second anchors are configured to deploy at substantially the same time.

17. The annuloplasty ring of claim 15, wherein the plurality of first anchors and the plurality of second anchors are configured to selectively deploy at different times.

18. The annuloplasty ring of claim 15, 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.

19. The annuloplasty ring of claim 18, wherein the plurality of first anchors are each adjacent to a corresponding one of the plurality of second anchors in the deployed configuration.

20. The annuloplasty ring of claim 19, wherein adjacent anchors deploy through a same window of the plurality of windows.

21. The annuloplasty ring of claim 19, wherein adjacent anchors deploy through separate, adjacent windows of the plurality of windows.

22. The annuloplasty ring of claim 15, 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.

23. The annuloplasty ring of claim 15, further comprising:

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

24. A method for percutaneous transcatheter repair of a heart valve, the method comprising:

percutaneously introducing a distal end of a first catheter into a left atrium of the heart;

inserting an annuloplasty ring, attached to a second catheter, through the first catheter into the left atrium, the ring including a superelastic shape memory material that transforms the ring from an elongate insertion geometry to an annular operable geometry as the ring exits the distal end of the first catheter; and

controlling a line, connected to the ring through the second catheter, to rotate an internal body member of the ring, the rotation deploying a plurality of tissue anchors from the ring.

25. The method of claim 24, wherein pulling the line rotates the internal body member in a first direction to deploy the plurality of anchors and pushing the line rotates the internal body member in a second direction to retract the plurality of anchors.

26. The method of claim 24, wherein percutaneously introducing the distal end of the first catheter into the left atrium of the heart comprises a trans-septal approach through the inferior vena cava, right atrium, and interatrial septum into the left atrium.

27. The method of claim 24, wherein percutaneously introducing the distal end of the first catheter into the left atrium of the heart comprises a retrograde approach through the aorta, aortic valve, left ventricle, and mitral valve into the left atrium.

28. The method of claim 24, wherein percutaneously introducing the distal end of the first catheter into the left atrium of the heart comprises a trans-apical approach through the apex of the heart, left ventricle, and mitral valve into the left atrium.