THREE-DIMENSIONAL ANNULOPLASTY RING

• US 20120143322A1
• Filed: 02/09/2012
• Published: 06/07/2012
• Est. Priority Date: 08/28/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: McCarthy, Patrick M., Rhee, Richard S., Schreck, Stefan G.
• Granted Patent: US 9,414,922 B2
• Time in Patent Office: Days
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61F 2250/0029 differing in bending or flexure capacity
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: Y10S 623/90 Stent for heart valve

Abstract

An annuloplasty ring having a three-dimensional discontinuous form generally arranged about an axis with two free ends that are axially offset. The ring is particularly suited for repair of the tricuspid valve, and more closely conforms to the annulus shape. The ring is more flexible in bending about radially extending axes than about the central axis. The ring may have an inner structural support covered by a pliable sleeve and/or a fabric tube. The structural support may have a varying cross-section, such as a C-shaped cross-section in a mid-section between two free ends and a rectangular cross-section at the free ends.

Claims

1. An annuloplasty ring sized and configured for attaching within a tricuspid annulus, comprising:

a relatively rigid inner body defining an elongated arcuate path, the inner body generally arranged about an axis and being discontinuous so as to define two free ends with a break therebetween, the inner body having, in plan view, a curvilinear anterior side terminating in a first free end, a relatively straight septal side terminating in a second free end, and a curvilinear posterior side extending between the anterior and septal sides, wherein the inner body is three-dimensional and conforms to a native tricuspid annulus when in a relaxed configuration so as not to unduly distort the annulus when secured thereto; and

a suture-permeable matrix closely surrounding the inner body.

2. The annuloplasty ring of claim 1, wherein the suture-permeable matrix includes a portion that conforms to the inner body and an outwardly-extending flange adapted to receive implantation sutures.

3. The annuloplasty ring of claim 1, wherein a middle portion of the inner body lies within a reference plane when in a relaxed configuration.

4. The annuloplasty ring of claim 3, wherein the second free end is axially offset from the reference plane.

5. The annuloplasty ring of claim 4, wherein the first free end is also axially offset from the reference plane.

6. The annuloplasty ring of claim 5, wherein the two free ends are both axially offset in the same direction from the reference plane.

7. The annuloplasty ring of claim 6, wherein the second free end is axially offset farther than the first free end from the reference plane.

8. An annuloplasty ring sized and configured for attaching within a tricuspid annulus, comprising:

a relatively rigid inner body defining an elongated arcuate path, the inner body generally arranged about an axis and being discontinuous so as to define two free ends with a break therebetween, the inner body having, in plan view, a curvilinear anterior side terminating in a first free end, a relatively straight septal side terminating in a second free end, and a curvilinear posterior side extending between the anterior and septal sides, wherein the inner body is three-dimensional such that the septal side that terminates in the second free end is formed in a gentle downward curve so as to be axially offset from a reference plane in which a middle portion of the inner body lies when in a relaxed configuration; and

a suture-permeable matrix closely surrounding the inner body.

9. The annuloplasty ring of claim 8, wherein the suture-permeable matrix includes a portion that conforms to the inner body and an outwardly-extending flange adapted to receive implantation sutures.

10. The annuloplasty ring of claim 8, wherein a majority of the inner body lies within the reference plane.

11. The annuloplasty ring of claim 8, wherein the first free end is also axially offset from the reference plane.

12. The annuloplasty ring of claim 11, wherein the two free ends are both axially offset in the same direction from the reference plane.

13. The annuloplasty ring of claim 12, wherein the second free end is axially offset farther than the first free end from the reference plane.

14. The annuloplasty ring of claim 8, wherein the inner body is more flexible in bending at the two free ends than in a midpoint thereof.

15. An annuloplasty ring sized and configured for attaching within a valve annulus, comprising:

a relatively rigid inner body defining an elongated arcuate path, the inner body generally arranged about an axis and being discontinuous so as to define two free ends with a break therebetween, the inner body being formed of at least one band that has a thinner axial dimension than a radial dimension so as to be more flexible in bending about radial lines than about the axis; and

a suture-permeable matrix closely surrounding the inner body.

16. The annuloplasty ring of claim 15, wherein there are a plurality of the bands combining to form the inner body.

17. The annuloplasty ring of claim 15, wherein the plurality of the bands are stacked axially.

18. The annuloplasty ring of claim 15, wherein the plurality of the bands are concentrically disposed about the axis and spaced radially from each other.

19. The annuloplasty ring of claim 15, wherein the inner body is embedded within the suture-permeable matrix.

20. The annuloplasty ring of claim 19, wherein the suture-permeable matrix includes a portion that conforms to the inner body and an outwardly-extending flange adapted to receive implantation sutures.