Physiologic tricuspid annuloplasty ring

• US 8,915,960 B2
• Filed: 08/30/2011
• Issued: 12/23/2014
• Est. Priority Date: 08/31/2010
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Carpentier, Alain F., Brunnett, William C., Campbell, Louis A., Chang, Da-Yu, Ford, Steven, Migliazza, John F., Rao, Anand
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Ganesan, Suba
• Application Number:
  US13/221,700
• Publication Number:
  US 20120071970A1
• Time in Patent Office: 1,211 Days
• Field of Search: 623 236- 241
• 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 2/2466 Delivery devices therefor
• CPC Class Codes: A61F 2230/0039 H-shaped
• CPC Class Codes: A61F 2230/0052 T-shaped

Abstract

A prosthetic tricuspid remodeling annuloplasty ring for use in tricuspid valve repairs to provide annular support after reconstructive valve surgery. The ring maintains an optimal annular dimension to prevent excessive dilatation of the natural valve annulus while adapting to the dynamic motion of the tricuspid annulus during the cardiac cycle. An exemplary ring features a waveform contour and may be constructed of a titanium core having a varying cross-section for selective flexibility for good Z-axis or out-of plane movement. The “waveform” contour and selective flexibility of the different segments of this ring are designed to adapt to the complex motion of the annulus. This reduces the stress on the anatomical structures and therefore minimizes the risk of arrhythmia and ring dehiscence.

Claims

1. A prosthetic tricuspid annuloplasty ring, comprising:

an asymmetric generally ovoid ring body having an inflow side and an outflow side with a first free end located adjacent an antero-septal commissure when implanted and a second free end located at a septal point, wherein the ring body extends in a clockwise direction as seen looking at the inflow side from the first free end around a first segment, a second segment, and a third segment that terminates in the second free end, and the ring body includes a relatively rigid inner core member and a suture-permeable interface surrounding the inner core member, wherein the inner core member, in the second segment, has a U-shaped radial cross-section open toward the inflow side with a first height h₁ and which, in the first and third segments, also has a U-shaped cross-section open toward the inflow side with lesser heights relative to h₁.

2. The tricuspid annuloplasty ring of claim 1, wherein the suture-permeable interface includes an outwardly projecting flange on an inflow edge of the ring body and an outer fabric cover, and the ring further includes a visible marker line on the fabric cover at the base of the flange on its outflow side.

3. The tricuspid annuloplasty ring of claim 1, wherein the core member includes gradual transitions between the U-shaped radial cross-section of the first height h₁ and the U-shaped cross-sections of lesser heights.

4. The tricuspid annuloplasty ring of claim 1, wherein at any one point around the core member the U-shaped radial cross-sections include side walls having a thickness t₁ and a web having a thickness t₂, and wherein the thicknesses t₁ and t₂ vary gradually around the core member to provide optimal flexibility.

5. The tricuspid annuloplasty ring of claim 4, wherein the thicknesses t₁ and t₂ taper down from the second segment to both the first and third segments.

6. The tricuspid annuloplasty ring of claim 1, wherein the core member has an in-plane bending stiffness measured by moving one free end in the radial plane with respect to the other free end that is at least 10 times the torsional out-of-plane bending stiffness measured by moving one free end vertically with respect to the other free end.

7. The tricuspid annuloplasty ring of claim 1, wherein the second segment is generally planar with the first segment rising up therefrom in a complex curve and the third segment descending down therefrom in a complex curve.

8. The tricuspid annuloplasty ring of claim 7, wherein the complex curves in both the first and third segments terminate in upturned free ends.

9. A prosthetic tricuspid annuloplasty ring, comprising:

a ring body circumscribing a central area and having an inflow side and an outflow side facing in opposite directions, a portion of the ring body being generally planar so as to define a radial plane, with a first free end and a second free end separated across a gap and the ring body extends at least half-way around the central area, wherein the ring body includes a relatively rigid inner core member having a U-shaped radial cross-section open toward the inflow side and an in-plane bending stiffness measured by moving one free end in the radial plane with respect to the other free end that is at least 10 times the torsional out-of-plane bending stiffness measured by moving one free end perpendicular to the radial plane with respect to the other free end.

10. The tricuspid annuloplasty ring of claim 9, wherein the core member has an in-plane bending stiffness that is between about 10-200 times the torsional out-of-plane bending stiffness.

11. The tricuspid annuloplasty ring of claim 9, wherein the core member has an in-plane bending stiffness that is between about 20-60 times the torsional out-of-plane bending stiffness.

12. The tricuspid annuloplasty ring of claim 9, wherein the second segment is generally planar with the first segment rising up therefrom in a complex curve and the third segment descending down therefrom in a complex curve, and wherein the complex curves in both the first and third segments terminate in upturned free ends.

13. The tricuspid annuloplasty ring of claim 9, further including a suture-permeable interface surrounding the core member, and an outer fabric covering, wherein the suture-permeable interface includes an outwardly projecting flange on an inflow edge of the ring body, and the ring further includes a visible marker line on the fabric cover at the base of the flange on its outflow side.

14. The tricuspid annuloplasty ring of claim 9, wherein the U-shaped radial cross-section of the core member in the second segment has a first height h₁ and in the first and third segments has lesser heights relative to h₁ and includes gradual transitions between the U-shaped radial cross-section of the first height h₁ and the U-shaped cross-sections of lesser heights.

15. The tricuspid annuloplasty ring of claim 9, wherein at any one point around the core member the U-shaped radial cross-sections include side walls having a thickness t₁ and a web having a thickness t₂, and wherein the thicknesses t₁ and t₂ vary gradually around the core member.