Annuloplasty ring with variable cross-section

• US 10,188,518 B2
• Filed: 08/15/2016
• Issued: 01/29/2019
• Est. Priority Date: 08/28/2001
• Status: Expired due to Fees

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: McCarthy, Patrick M., Rhee, Richard S., Schreck, Stefan
• Primary Examiner(s): Pellegrino, Brian
• Application Number:
  US15/237,535
• Publication Number:
  US 20160354206A1
• Time in Patent Office: 897 Days
• 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. A deliver template having a mounting ring with about the same shape as the ring facilitates implant, and may be releasably attached to a delivery handle. The deliver template may include a plurality of cutting guides for releasably attaching the annuloplasty ring thereto while presenting maximum outer surface area of the ring. The template may have an outwardly-facing groove to receive and retain the ring.

Claims

1. An elongated annuloplasty ring, comprising:

an elongated ring body comprising an inner single piece metallic structural support surrounded by a suture permeable interface, the ring body surrounding a central open area through which passes a flow axis and being discontinuous so as to define two free ends at a break in continuity around a periphery of the ring body, wherein the ring body has a relaxed configuration shaped to mimic a three-dimensional path along a non-planar native valve annulus,

wherein the structural support has a radial cross-section that gradually changes around a length of the structural support and has a C-shaped part in a mid-portion, and wherein the two free ends of the structural support are rectangular in radial cross-section and are more flexible in bending about the flow axis than the C-shaped part of the cross-section, and

wherein the suture permeable interface includes a tubular inner portion that surrounds the structural support and an outer flange through which implantation sutures can pass, the outer flange is curved so as to be convex on its outer surface, and the outer flange is connected to the inner tubular portion with a plurality of circumferentially spaced apart radial walls so as to create a celled structure.

2. The annuloplasty ring as in claim 1, wherein the two free ends of the ring body are axially offset from each other.

3. The annuloplasty ring as in claim 2, wherein the two free ends of the ring body are axially offset from each other by a distance of about 2-15 mm.

4. The annuloplasty ring as in claim 1, wherein the C-shaped part defines an outwardly-facing groove between an upper web and a lower web, both extending from an inner base portion.

5. The annuloplasty ring as in claim 4, wherein the upper web extends slightly farther radially outward than the lower web.

6. An elongated annuloplasty ring, comprising:

an elongated three-dimensional ring body comprising an inner structural support surrounded by a flexible suture-permeable outer layer, the ring body surrounding a central open area through which passes a flow axis and being discontinuous so as to define two free ends at a break in continuity around a periphery of the ring body, wherein the ring body is made of a rigid yet elastic material and has a relaxed configuration shaped to mimic a non-planar path along a native valve annulus, wherein the outer layer is silicone; and

wherein the structural support has a radial cross-section that changes around a length of the structural support and is partly C-shaped in a midpoint of the ring body defining an outwardly-facing groove between an upper web and a lower web, both extending from an inner base portion.

7. The annuloplasty ring as in claim 6, wherein the cross-section of the structural support changes from the midpoint to both of two free ends thereof, and a transition between the cross-section at the midpoint and the cross-sections at the two free ends of the structural support is gradual.

8. The annuloplasty ring as in claim 6, wherein the cross-section of the structural support changes from the midpoint to both of two free ends thereof, and the webs gradually diminish in radial dimension until all that is left at the free ends of the structural support is the inner base portion.

9. The annuloplasty ring as in claim 6, wherein the upper web extends slightly farther radially outward than the lower web.

10. The annuloplasty ring as in claim 6, wherein the two free ends of the ring body are axially offset from each other by a distance of about 2-15 mm.

11. An annuloplasty ring, comprising:

a ring body comprising an inner single piece metallic structural support surrounded by a suture permeable interface, the ring body surrounding a central open area through which passes a flow axis and being discontinuous so as to define two free ends at a break in continuity around a periphery of the ring body, wherein the ring body has a relaxed configuration following a three-dimensional path configured to conform to a valve annulus,

wherein the structural support has two free ends and a radial cross-section that gradually changes around a length of the structural support and has a C-shaped part in a mid-portion, and wherein the two free ends of the structural support are rectangular in radial cross-section and are more flexible in bending about the axis than the C-shaped part of the cross-section, and wherein

the annuloplasty ring is configured to conform to a tricuspid valve annulus, and the inner structural support defines a curvilinear anterior side ending in one of the free ends of the structural support, a straight septal side ending in the other of the free ends of the structural support, and a curvilinear posterior side extending between the anterior and septal sides, wherein a portion of the posterior side lies in a plane perpendicular to the flow axis.

12. The annuloplasty ring as in claim 11, wherein the two free ends of the ring body are axially offset with respect to each other, and the posterior side and anterior side together lie in the plane all the way to the first free end of the ring body.

13. An annuloplasty ring, comprising:

a three-dimensional ring body comprising an inner structural support covered by a flexible suture-permable outer layer, the ring body surrounding a central open area through which passes a flow axis and being discontinuous so as to define two free ends at a break in continuity around a periphery of the ring body; and

wherein the structural support has a radial cross-section that changes around a length of the structural support and is partly C-shaped in a midpoint of the ring body defining an outwardly-facing groove between an upper web and a lower web, both extending from an inner base portion, wherein

the cross-section of the structural support changes from the midpoint to both of two free ends thereof, and wherein

the annuloplasty ring is configured to conforms to a tricuspid valve annulus, and the inner structural support defines a curvilinear anterior side ending in one of the free ends of the structural support, a straight septal side ending in the other of the free ends of the structural support, and a curvilinear posterior side extending between the anterior and septal sides, wherein a portion of the posterior side lies in a plane perpendicular to the flow axis.

14. The annuloplasty ring as in claim 13, wherein the two free ends of the structural support are both axially offset from an annulus reference plane through a midpoint of the ring body.

15. An elongated annuloplasty ring, comprising:

an elongated ring body comprising an inner single piece metallic structural support surrounded by a suture permeable interface, the ring body surrounding a central open area through which passes a flow axis and being discontinuous so as to define two free ends at a break in continuity around a periphery of the ring body, wherein the ring body has a relaxed configuration shaped to mimic a three-dimensional path along a non-planar native valve annulus,

wherein the structural support has a radial cross-section that gradually changes around a length of the structural support and has a C-shaped part in a mid-portion, and wherein the two free ends of the structural support are rectangular in radial cross-section and are more flexible in bending about the flow axis than the C-shaped part of the cross-section, and wherein the two free ends of the ring body are axially offset from each other.

16. The annuloplasty ring as in claim 15, wherein the two free ends of the ring body are axially offset from each other by a distance of about 2-15 mm.

17. An elongated annuloplasty ring, comprising:

an elongated three-dimensional ring body comprising an inner structural support surrounded by a flexible suture-permeable outer layer, the ring body surrounding a central open area through which passes a flow axis and being discontinuous so as to define two free ends at a break in continuity around a periphery of the ring body, wherein the ring body is made of a rigid yet elastic material and has a relaxed configuration shaped to mimic a non-planar path along a native valve annulus, wherein the two free ends of the ring body are axially offset from each other; and

wherein the structural support has a radial cross-section that changes around a length of the structural support and is partly C-shaped in a midpoint of the ring body defining an outwardly-facing groove between an upper web and a lower web, both extending from an inner base portion.

18. The annuloplasty ring as in claim 17, wherein the two free ends of the ring body are both axially offset in the same direction from the midpoint of the ring body.

19. The annuloplasty ring as in claim 17, wherein the two free ends of the ring body are axially offset from each other by a distance of about 2-15 mm.