Mitral valve annuloplasty ring having a posterior bow

• US 6,858,039 B2
• Filed: 07/08/2002
• Issued: 02/22/2005
• Est. Priority Date: 07/08/2002
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: McCarthy, Patrick
• Primary Examiner(s): Barrett, Thomas C.
• Application Number:
  US10/192,516
• Publication Number:
  US 20040006384A1
• Time in Patent Office: 960 Days
• Field of Search: 623 236- 237
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2448 D-shaped rings
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility

Abstract

A mitral heart valve annuloplasty ring having a posterior bow that conforms to an abnormal posterior aspect of the mitral annulus. The ring may be generally oval having a major axis and a minor axis, wherein the posterior bow may be centered along the minor axis or offset in a posterior section. The ring may be substantially planar, or may include upward bows on either side of the posterior bow. The ring may include a ring body surrounded by a suture-permeable fabric sheath, and the ring body may be formed of a plurality of concentric ring elements. The ring is semi-rigid and the posterior bow is stiff enough to withstand deformation once implanted and subjected to normal physiologic stresses. The ring elements may be bands of semi-rigid material. A method of repairing an abnormal mitral heart valve annulus having a depressed posterior aspect includes providing a ring with a posterior bow and implanting the ring to support the annulus without unduly stressing the attachment sutures.

Claims

1. An annuloplasty ring for implantation in a mitral valve annulus, said annuloplasty ring comprising:

a rounded ring body having an anterior section adapted to be implanted on the anterior aspect of the mitral valve annulus, and a posterior section adapted to be implanted on the posterior aspect of the mitral valva annulus;

wherein the ring body is oriented about a central flow axis, the flow axis defining an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus; and

,

wherein in the posterior section the ring body bows downward out of a plane perpendicular to the central flow axis, and wherein the downward bow in off-center in the posterior section and exhibits smooth curvilinear transitions to the adjacent ring body sections.

2. The annuloplasty ring of claim 1, wherein, in the posterior section, the ring body bows downward between about 2-15 mm as measured along the flow axis from a point around the ring body at which the downward bow begins to a lowest point of the downward bow.

3. The annuloplasty ring of claim 2, wherein the ring body bows downward between about 4-8 mm.

4. The annuloplasty ring of claim 1, wherein the bow in the ring body is off-center in the posterior section toward a posterio-medial side of the ring body as viewed from an inflow perspective.

5. The annuloplasty ring of claim 4, wherein in plan view as seen along the flow axis the ring body generally defines an oval shape with a major axis perpendicular to a minor axis, wherein the minor axis bisects both the anterior and posterior sections, and wherein the bow in the posterior section is offset toward the posterio-medial side by about 20% of the entire major axis width of the ring body.

6. The annuloplasty ring of claim 4, wherein in plan view as seen along the flow axis the ring body generally defines an oval shape with a major axis perpendicular to a minor axis, wherein the minor axis bisects both the anterior and posterior sections, and wherein the bow in the posterior section is centered at a clock position, with 12:

00 being centered in the anterior side, and the bow is centered between 3;

00 and 6;

00.

7. The annuloplasty ring of claim 1, wherein the ring body is made of a malleable material such that the bow in the ring body may be manually reshaped.

8. The annuloplasty ring of claim 1, wherein the ring body is made of a semi-rigid material that will retain its posterior bow in opposition to the stresses that will be imparted by muscles of the heart throughout each beating cycle.

9. The annuloplasty ring of claim 1, wherein in the anterior section the ring body bows upward from adjacent trigone markers.

10. The annuloplasty ring of claim 1, wherein the ring body comprises a plurality of ring elements concentrically disposed.

11. The annuloplasty ring of claim 10, further including a polymer strip in between each ring element.

12. The annuloplasty ring of claim 10, wherein the ring elements comprise bands that have a substantially larger height in the flow axis dimension than in the dimension perpendicular to the flow axis.

13. The annuloplasty ring of claim 12, wherein the ring elements have varying heights so that the ring body is more flexible in the posterior section than around the remainder of the ring body.

14. A method of repairing a mitral heart valve annulus that has a posterior aspect that is depressed downward along the blood flow axis relative to an anterior aspect, comprising:

implanting an annuloplasty ring having an anterior section sized to fit the anterior aspect of the annulus and a posterior section sized to the posterior aspect, wherein the ring posterior section bows downward parallel to the central axis relative to the anterior section.

15. The method of claim 14, wherein the annuloplasty ring is malleable and the surgeon adjusts the bow in the posterior section manually.

16. The method of claim 14, wherein the ring posterior section bows downward between about 4-8 mm parallel to the central axis relative to the anterior section.

17. The method of claim 14, wherein the posterior aspect is depressed downward along the blood flow axis off-center in the posterior section and the bow in the ring is similarly off-center in the posterior section.

18. The method of claim 17, wherein the posterior aspect is depressed downward along the blood flow axis toward a posterio-medial side of the mitral annulus and the bow in the ring is similarly off-center in the posterior section toward a posterio-medial side of the ring.

19. The method of claim 14, wherein the ring body is made of a malleable material and the method includes manually reshaping the ring to have the posterior bow.

20. A method of repairing a mitral heart valve annulus that has a downwardly depressed posterior aspect, an anterior aspect, and a blood flow axis, comprising:

inspecting the shape of the mitral annulus;

selecting a three-dimensional annuloplasty ring based on the shape of the mitral annulus, the annuloplasty ring having an anterior section and a posterior section generally arranged around a central axis, the central axis defining an upward direction and a downward direction, wherein the ring posterior section bows downward out of a plane perpendicular to the central axis; and

implanting the annuloplasty ring so that the ring posterior section attaches to the posterior aspect of the mitral valve annulus and the posterior section bows in the blood flow direction.

21. An annuloplasty ring for implantation in a mitral valve annulus, said annuloplasty ring comprising:

a rounded ring body having an anterior section adapted to be implanted on the anterior aspect of the mitral valve annulus and a posterior section adapted to be implanted on the posterior aspect of the mitral valve annulus;

wherein the ring body is oriented about a central flow axis, the flow axis defining an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus wherein the ring body comprises a plurality of bands concentrically disposed that have a substantially larger height in the flow axis dimension than in the dimension perpendicular to the flow axis, and wherein the bands have varying heights so that the ring body is more flexible in the posterior section than around the remainder of the ring body; and

,

wherein in the posterior section the ring body bows downward out of a plane perpendicular to the central flow axis.

22. The annuloplasty ring of claim 21, further including a polymer strip in between each ring element.

23. The annuloplasty ring of claim 21, wherein the bands overlap in the anterior section of the ring body and are fastened together at multiple points.