Annuloplasty ring for mitral valve prolapse

• US 7,294,148 B2
• Filed: 04/29/2004
• Issued: 11/13/2007
• Est. Priority Date: 04/29/2004
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: McCarthy, Patrick M.
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): Prone; Christopher Daniel
• Application Number:
  US10/834,556
• Publication Number:
  US 20050246014A1
• Time in Patent Office: 1,293 Days
• Field of Search: None
• US Class Current: 623/2.36
• CPC Class Codes: A61F 2/2448 D-shaped rings

Abstract

A mitral annuloplasty ring that has an outward and an upward posterior bow. The ring defines a closed, modified oval shape with a minor-major axis dimension ratio of between about 3.3:4 to 4:4. The ring is made of a material 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. As a result, the annuloplasty ring corrects for pathologies associated with mitral valve prolapse, or Barlow'"'"'s syndrome, in which the leaflets tend to be elongated or floppy.

Claims

1. A mitral annuloplasty ring, comprising a ring body made of a material that will substantially resist distortion when subjected to the stress imparted thereon after implantation in the mitral valve annulus of an operating human heart, the ring body defining:

an anterior segment and a posterior portion opposite the anterior segment;

right and left sides between the anterior segment and posterior portion;

a central flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus when the annuloplasty ring is implanted;

a modified oval shape with a minor axis extending between the anterior segment and posterior portion, and a major axis extending between the sides; and

a bow in the posterior portion that extends both radially outward and axially upward, wherein an outward convexity of the bow has a smaller radius than adjacent sections, and wherein an axial height h of the bow exceeds about 3 mm.

2. The mitral annuloplasty ring of claim 1, wherein the radially outward portion of the bow is not co-extensive with the axially upward portion.

3. The mitral annuloplasty ring of claim 2, wherein in atrial plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis, and wherein the ring body has a minor-major dimension ratio of between 3.3:

4(82.5%) and 4;

4(100%).

4. The mitral annuloplasty ring of claim 1, wherein the axial height h of the bow is between about 3-10 mm.

5. The mitral annuloplasty ring of claim 1, wherein in plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis, and wherein the ring body has a minor-major dimension ratio of between 3.3:

4 (82.5%) and 4;

4 (100%).

6. The mitral annuloplasty ring of claim 5, wherein the minor-major dimension ratio is about 3.5:

4 (87.5%).

7. The mitral annuloplasty ring of claim 5, wherein the bow is centered about the minor axis and has an angular extent of between 90-110°

.

8. The mitral annuloplasty ring of claim 7, wherein the bow has an angular extent of about 100°

.

9. The mitral annuloplasty ring of claim 1, wherein in atrial plan view as seen along the flow axis the ring body has an anterior segment generally defined between an anterolateral trigone and a posteromedial trigone, and a posterior portion around the remaining periphery of the ring body and between the trigones, the posterior portion being divided into three sequential segments, P₁, P₂, and P₃, starting from the anterolateral trigone and continuing in a counterclockwise direction, and wherein the bow in the posterior portion is wholly within the middle segment P₂ of the posterior portion of the ring.

10. The mitral annuloplasty ring of claim 1, wherein in atrial plan view as seen along the flow axis the ring body has an anterior segment generally defined between an anterolateral trigone and a posteromedial trigone, and a posterior portion around the remaining periphery of the ring body and between the trigones, the posterior portion being divided into three sequential segments, P₁, P₂, and P₃, starting from the anterolateral trigone and continuing in a counterclockwise direction, and wherein the bow in the posterior portion is within the middle segment P₂ and at least one other segment P₁ or P₃ of the posterior portion of the ring.

11. A mitral annuloplasty ring, comprising a ring body made of a material that will substantially resist distortion when subjected to the stress imparted thereon after implantation in the mitral valve annulus of an operating human heart, the ring body defining:

a rounded ring body having an anterior segment and a posterior portion;

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 in atrial plan view as seen along the flow axis the anterior segment is generally defined between an anterolateral trigone and a posteromedial trigone, and the posterior portion extends around the remaining periphery of the ring body and between the trigones, the posterior portion being divided into three sequential segments, P₁, P₂, and P₃, starting from the anterolateral trigone and continuing in a counterclockwise direction; and

,

wherein in the posterior portion the ring body bows upward out of a plane perpendicular to the central flow axis and wholly within the middle segment P₂ of the posterior portion of the ring, and also has a radially outward curve more pronounced than adjacent sections.

12. The mitral annuloplasty ring of claim 11, wherein an axial height h of the upward bow exceeds about 3 mm.

13. The mitral annuloplasty ring of claim 12, wherein the axial height h of the upward bow is between about 3-10 mm.

14. The mitral annuloplasty ring of claim 12, wherein in atrial plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis, and wherein the ring body has a minor-major dimension ratio of between 3.3:

4 (82.5%) and 4;

4 (100%).

15. The mitral annuloplasty ring of claim 14, wherein the minor-major dimension ratio is about 3.5:

4 (87.5%).

16. The mitral annuloplasty ring of claim 14, wherein the bow is centered about the minor axis and has an angular extent of between 90-110°

.

17. The mitral annuloplasty ring of claim 11, wherein the radially outward curve is not co-extensive with the upward bow.

18. A mitral annuloplasty ring, comprising a ring body made of a material that will substantially resist distortion when subjected to the stress imparted thereon after implantation in the mitral valve annulus of an operating human heart, the ring body defining:

a modified oval-shaped ring body 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 from the left atrium to the left ventricle, and wherein in plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis,

the ring body having in atrial plan view an anterior segment generally defined between an anterolateral trigone and a posteromedial trigone, and a posterior portion around the remaining periphery of the ring body and between the trigones, the posterior portion being divided into three sequential segments, P₁, P₂, and P₃ starting from the anterolateral trigone and continuing in a counterclockwise direction, the segments generally corresponding to the size of the native posterior leaflet cusps, wherein the minor axis intersects both the anterior segment and the P₂ segment of the posterior portion; and

,

wherein the ring body lies substantially in a plane defined by the major and minor axes or in a saddle-shaped three-dimensional surface except for the P₂ segment of the posterior portion located which is deflected upward and outward in a more pronounced, smaller radius curve with respect to the adjacent sections of the ring body, wherein an axial height h of the upward deflection exceeds about 3 mm.

19. The mitral annuloplasty ring of claim 18, the outward deflection is not co-extensive with the upward deflection.

20. The mitral annuloplasty ring of claim 18, wherein the axial height h of the upward deflection is between about 3-10 mm.

21. The mitral annuloplasty ring of claim 18, wherein in atrial plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis, and wherein the ring body has a minor-major dimension ratio of between 3.3:

4 (82.5%) and 4;

4 (100%).

22. The mitral annuloplasty ring of claim 21, wherein the minor-major dimension ratio is about 3.5:

4 (87.5%).

23. The mitral annuloplasty ring of claim 21, wherein the outward deflection is centered about the minor axis and has an angular extent of between 90-110°

.

24. A mitral annuloplasty ring, comprising a ring body made of a material that will substantially resist distortion when subjected to the stress imparted thereon after implantation in the mitral valve annulus of an operating human heart, the ring body defining:

an anterior segment and a posterior portion opposite the anterior segment;

right and left sides between the anterior segment and posterior portion;

a central flow axis having an upward direction and a downward direction, the downward direction corresponding to the direction of blood flow through the mitral valve annulus when the annuloplasty ring is implanted;

a modified oval shape with a minor axis extending between the anterior segment and posterior portion, and a major axis extending between the sides, wherein in plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis, and wherein the ring body has a minor-major dimension ratio of between 3.3;

4 (82.5%) and 4;

4 (100%); and

a bow in the posterior portion that extends both radially outward and axially upward, wherein an outward convexity of the bow has a smaller radius than adjacent sections.

25. The mitral annuloplasty ring of claim 24, wherein the minor-major dimension ratio is about 3.5:

4 (87.5%).

26. The mitral annuloplasty ring of claim 24, wherein the bow is centered about the minor axis and has an angular extent of between 90-110°

.

27. The mitral annuloplasty ring of claim 24, wherein the radially outward portion of the bow is co-extensive with the axially upward portion.

28. The mitral annuloplasty ring of claim 24, wherein the radially outward portion of the bow is not co-extensive with the axially upward portion.

29. The mitral annuloplasty ring of claim 24, wherein the axial height h of the bow is between about 3-10 mm.

30. The mitral annuloplasty ring of claim 24, wherein in atrial plan view as seen along the flow axis the anterior segment is generally defined between an anterolateral trigone and a posteromedial trigone, and the posterior portion extends around the remaining periphery of the ring body and between the trigones, the posterior portion being divided into three sequential segments, P₁, P₂, and P₃, starting from the anterolateral trigone and continuing in a counterclockwise direction, and wherein the bow in the posterior portion is wholly within the middle segment P₂ of the posterior portion of the ring.

31. The mitral annuloplasty ring of claim 24, wherein in atrial plan view as seen along the flow axis the anterior segment is generally defined between an anterolateral trigone and a posteromedial trigone, and the posterior portion extends around the remaining periphery of the ring body and between the trigones, the posterior portion being divided into three sequential segments, P₁, P₂, and P₃, starting from the anterolateral trigone and continuing in a counterclockwise direction, and wherein the bow in the posterior portion is within the middle segment P₂ and at least one other segment P₁ or P₃ of the posterior portion of the ring.

32. The mitral annuloplasty ring of claim 31, wherein the bow in the posterior portion extends into both the first and third segments P₁ and P₃ of the posterior portion.

33. The mitral annuloplasty ring of claim 31, wherein the bow in the posterior portion extends into only one of the first and third segments P₁ and P₃ of the posterior portion.

34. The mitral annuloplasty ring of claim 31, wherein the radially outward portion of the bow extends into only one of the first and third segments P₁ and P₃ of the posterior portion.

35. A mitral annuloplasty ring, comprising a ring body made of a material that will substantially resist distortion when subjected to the stress imparted thereon after implantation in the mitral valve annulus of an operating human heart, the ring body defining:

a rounded ring body having an anterior segment and a posterior portion;

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 portion the ring body bows upward out of a plane perpendicular to the central flow axis to an axial height h of that exceeds about 3 mm and also has a radially outward curve more pronounced than adjacent sections.

36. The mitral annuloplasty ring of claim 35, wherein the axial height h of the upward bow is between about 3-10 mm.

37. The mitral annuloplasty ring of claim 35, wherein in atrial plan view as seen along the flow axis the ring body has a major axis perpendicular to a minor axis, the major and minor axes being perpendicular to the flow axis, and wherein the ring body has a minor-major dimension ratio of between 3.3:

4 (82.5%) and 4;

4 (100%).

38. The mitral annuloplasty ring of claim 35, wherein the minor-major dimension ratio is about 3.5:

4 (87.5%).

39. The mitral annuloplasty ring of claim 35, wherein the bow is centered about the minor axis and has an angular extent of between 90-110°

.

40. The mitral annuloplasty ring of claim 35, wherein the radially outward curve is not co-extensive with the upward bow.