Mitral Annuloplasty Ring Having Upward Bows

• US 20080097593A1
• Filed: 12/18/2007
• Published: 04/24/2008
• Est. Priority Date: 11/13/2001
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rhee, Richard, Bolling, Steven
• Granted Patent: US 8,236,050 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

Abstract

Methods of implanting an annuloplasty ring to correct maladies of the mitral annulus that not only reshapes the annulus but also reconfigures the adjacent left ventricular muscle wall. The ring may be continuous and is made of a relatively rigid material, such as Stellite. The ring has a generally oval shape that is three-dimensional at least on the posterior side. A posterior portion of the ring rises or bows upward from adjacent sides to pull the posterior aspect of the native annulus farther up than its original, healthy shape. In doing so, the ring also pulls the ventricular wall upward which helps mitigate some of the effects of congestive heart failure. Further, one or both of the posterior and anterior portions of the ring may also bow inward. The methods include securing the annuloplasty ring with the anterior portion against the annulus anterior aspect and the posterior portion against the annulus posterior aspect so that the ring posterior portion elevates, and may also pull radially inward, the annulus posterior aspect and corrects the mitral regurgitation.

Claims

1. A mitral annuloplasty ring for implantation in a mitral valve annulus having an anterior aspect and a posterior aspect, the annuloplasty ring comprising:

a continuous ring body having an anterior portion, a posterior portion opposite the anterior portion, right and left sides between the anterior and posterior portions with transition segments between the sides and the anterior and posterior portions;

wherein the ring body is oriented about a central axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus, the ring having in plan view perpendicular to the central axis a major axis and a minor axis;

wherein the anterior portion has an upward bow, and,

wherein the posterior portion has an upward bow.

2. The annuloplasty ring of claim 1, wherein the ring is substantially saddle-shaped with the right and left sides also having upward bows.

3. The annuloplasty ring of claim 2, wherein the right and left sides each rise upward to an axial position about the same level as the anterior portion.

4. The annuloplasty ring of claim 1, wherein both the anterior and posterior portions have approximately equal height upward bows.

5. The annuloplasty ring of claim 1, wherein the posterior portion bows radially inward to a radial position along the minor axis that is closer to the central axis than an imaginary posterior projection in plan view of the sides toward each other.

6. The annuloplasty ring of claim 5, wherein the radial position is about 30-50% closer to the central axis than the imaginary posterior projection in plan view of the sides toward each other.

7. The annuloplasty ring of claim 5, wherein the anterior portion of the ring bows radially inward to a radial position along the minor axis that is closer to the central axis than an imaginary anterior projection in plan view of the sides toward each other.

8. The annuloplasty ring of claim 1, wherein the ring body is comprised of a material having a high modulus of elasticity that will substantially resist distortion when subjected to the stress imparted thereon when the ring is implanted in the mitral valve annulus of an operating human heart.

9. The annuloplasty ring of claim 8, wherein the ring is comprised of titanium.

10. The annuloplasty ring of claim 1, wherein the ring body periphery comprises gentle blended curves except in the posterior portion which exhibits a relatively sudden elevation from adjacent sides.

17. The annuloplasty ring of claim 1, wherein the anterior portion of the ring bows radially inward to a radial position along the minor axis that is closer to the central axis than an imaginary anterior projection in plan view of the sides toward each other.

11. A mitral annuloplasty ring for implantation in a mitral valve annulus having an anterior aspect and a posterior aspect, comprising:

a continuous ring body made of a material having a high modulus of elasticity that will substantially resist distortion when subjected to the stress imparted thereon when the ring is implanted in the mitral valve annulus of an operating human heart,

the ring body being oriented about a central axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus, the ring having in plan view perpendicular to the central Z axis a major Y axis and a minor X axis,

the ring body having an anterior portion, a posterior portion opposite the anterior portion, and right and left sides between the anterior and posterior portions, and

wherein the ring has equal height upward axial bows on both the anterior and posterior portions.

12. The annuloplasty ring of claim 11, wherein the ring body is substantially saddle-shaped with the right and left sides also having upward bows.

13. The annuloplasty ring of claim 12, wherein the right and left side upward bows are about the same height as a height of the anterior portion.

14. The annul oplasty ring of claim 11, wherein both the anterior and posterior portions bow upward to axial positions above the height of the right and left sides.

15. The annuloplasty ring of claim 11, wherein the posterior portion bows radially inward to a radial position along the minor axis that is closer to the central axis than an imaginary posterior projection in plan view of the sides toward each other.

16. The annuloplasty ring of claim 15, wherein the radial position is about 30-50% closer to the central axis than the imaginary posterior projection in plan view of the sides toward each other.

18. A mitral annuloplasty ring for implantation in a mitral valve annulus having an anterior aspect and a posterior aspect, said annuloplasty ring comprising:

a continuous ring body having an anterior portion, a posterior portion opposite the anterior portion, right and left sides between the anterior and posterior portions with transition segments between the sides and the anterior and posterior portions,

wherein the ring body is oriented about a central axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus, the ring having in plan view perpendicular to the central axis a major axis and a minor axis,

wherein the ring body is substantially saddle-shaped with the anterior and posterior portions having upward bows, and the right and left sides also having upward bows, and

wherein the anterior and posterior portions bow radially inward to radial positions along the minor axis that are closer to the central axis than imaginary anterior and posterior projections in plan view of the sides toward each other.

19. The annuloplasty ring of claim 18, wherein the posterior portion bows radially inward to a radial position along the minor axis that is about 30-50% closer to the central axis than the imaginary posterior projection in plan view of the sides toward each other.

20. The annuloplasty ring of claim 18, wherein the posterior portion bows radially inward farther than does the anterior portion.

21. The annuloplasty ring of claim 18, wherein the posterior portion upward bow is higher than the anterior portion upward bow.

22. The annuloplasty ring of claim 21, wherein the anterior portion upward bow is 10-20% of the height of the posterior portion upward bow.

23. The annuloplasty ring of claim 18, wherein the posterior portion upward bow rises about 3-8 mm above adjacent transition segments.

24. The annuloplasty ring of claim 18, wherein the posterior portion is generally rounded except for a plateau at its highest point on the minor axis.

25. The annuloplasty ring of claim 18, wherein the ring body is comprised of a material having a high modulus of elasticity that will substantially resist distortion when subjected to the stress imparted thereon when the ring is implanted in the mitral valve annulus of an operating human heart.