Intra-annular mounting frame for aortic valve repair

• US 20080086204A1
• Filed: 05/03/2007
• Published: 04/10/2008
• Est. Priority Date: 10/06/2006
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: BioStable Science & Engineering, Inc.
• Inventors: Rankin, J. Scott
• Granted Patent: US 8,163,011 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2442 Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 2240/002 Designing or making customized prostheses

Abstract

An intra-annular mounting frame useful for, inter alia, restoring the geometry of a valve to achieve proper coaptation.

Claims

1. An intra-annular mounting frame for a valve having a radius, diameter and circumference, comprising:

a plurality of curvatures, each of the curvatures curved in a first plane and curved in a second plane with the center of each of the curvatures below the ends of each of the curvatures, with each curvature corresponding to a valve'"'"'s three-dimensional geometry about a cusp of the valve; and

a plurality of points interconnecting the ends of each of the curvatures to form an interior area with each point corresponding to a valve'"'"'s three-dimensional geometry about a commissure of the valve.

2. The mounting frame of claim 1 wherein the frame comprises three curvatures and three points.

3. The mounting frame of claim 1 wherein the frame comprises two curvatures and two points.

4. The mounting frame of claim 1 further comprising a plurality of posts, one of which extends from each of the plurality of points.

5. The mounting frame of claim 4 wherein the posts extend toward the interior area of the frame at an angle of from about 60 degrees to about 90 degrees measured from the internal area of a latitudinal plane of the frame.

6. The mounting frame of claim 4 wherein the posts extend away from the interior area of the frame at an angle of from about 90 degrees to about 120 degrees measured from the internal area of a latitudinal plane of the frame.

7. The mounting frame of claim 4 wherein the posts extending perpendicularly upward from the latitudinal plane of the frame.

8. The mounting frame of claim 4 wherein each post comprises a length equal to about the radius of the valve.

9. The mounting frame of claim 4 wherein each post comprises a length of about 70% to about 130% of the radius of the valve.

10. The mounting frame of claim 4 wherein the length of the post is of from about 8 millimeters to about 16 millimeters.

11. The mounting frame of claim 1 wherein the frame has a circumference of about the circumference of the valve.

12. The mounting frame of claim 1 wherein the frame has a diameter of about 16 millimeters to about 30 millimeters.

13. The mounting frame of claim 1 wherein the frame has a diameter less than the diameter of the valve.

14. The mounting frame of claim 13 wherein the frame has a diameter of about 2 millimeters to about 8 millimeters less than the diameter of the valve.

15. The mounting frame of claim 1 wherein the frame is comprised of metal.

16. The mounting frame of claim 15 wherein the frame comprises metal wire.

17. The mounting frame of claim 1 wherein the frame is comprised of a material selected from the group consisting of plastics, polymers, metal, thermoplastics, resins, and combinations thereof.

18. The mounting frame of claim 1 wherein the frame further comprises perforations through the frame.

19. The mounting frame of claim 1 wherein the frame further comprises stripes through the frame.

20. The mounting frame of claim 1 further comprising a surface covering of polymer-type fiber cloth.

21. The mounting frame of claim 1 further comprising a surface covering of gluteraldehyde-fixed bovine pericardium.

22. An intra-annular mounting frame for mounting into an aortic valve having an aortic wall, cusps and commissures, comprising:

a plurality of curvatures for extending about the cusps'"'"' location on the aortic wall;

a plurality of points interconnecting the plurality of curvatures; and

a plurality of post, one of which extends from each point.

23. The mounting frame of claim 22 wherein the posts have a length about equal to a radius of the valve.

24. The mounting frame of claim 22 wherein the posts extend toward the commissures of the aortic valve.

25. A method of repairing an aortic valve having an aortic wall, cusps and commissures, comprising:

a) providing an intra-annular mounting frame comprising,

a plurality of curvatures, each of the curvatures curved in a first plane and curved in a second plane with the center of each of the curvatures below the ends of each of the curvatures, with each curvature corresponding to a valve'"'"'s three-dimensional geometry about a cusp of the valve; and

a plurality of points interconnecting the ends of each of the curvatures to form an interior area with each point corresponding to a valve'"'"'s three-dimensional geometry about a commissure of the valve;

b) inserting the intra-annular mounting frame directly into the aortic valve annulus with the intra-annular mounting frame positioned up under the cusps; and

c) suturing the intra-annular mounting frame into the aortic valve with the sutures passing through the aortic wall and passing both above and below the cusps.

26. The method of claim 25 further comprising the sutures passing through perforations in the intra-annular mounting frame.

27. The method of claim 25 further comprising the sutures passing through stripes in the intra-annular mounting frame.

28. The method of claim 25 wherein the sutures are mattress sutures.

29. The method of claim 25 wherein step c) further comprises buttressing tissue of the aortic wall by placing pledgets onto the sutures above the cusps of the aortic valve.

30. The method of claim 26 wherein the pledgets comprise felt pledgets.

31. The method of claim 25 further comprising:

d) reorienting the cusps and commissures of the aortic valve so that the aortic valve has a diameter of from about 16 millimeters to about 27 millimeters.

32. A method of repairing an aortic valve having an aortic wall, cusps and commissures, comprising the steps of:

a) providing an intra-annular mounting frame comprising,

a plurality of curvatures, each of the curvatures curved in a first plane and curved in a second plane with the center of each of the curvatures below the ends of each of the curvatures, with each curvature corresponding to a valve'"'"'s three-dimensional geometry about a cusp of the valve; and

a plurality of points interconnecting the ends of each of the curvatures to form an interior area with each point corresponding to a valve'"'"'s three-dimensional geometry about a commissure of the valve;

b) inserting the intra-annular mounting frame directly into the aortic valve annulus with the intra-annular mounting frame positioned up under the cusps; and

c) employing a plurality of support arcs similar in shape to the curvatures of the intra-annular mounting frame above the cusps of the aortic valve; and

d) passing sutures through the aortic wall and between the intra-annular mounting frame and the plurality of support arcs.

33. The method of claim 32 wherein the plurality of support arcs further comprise cloth covered arcs.

34. The method of claim 32 further comprising:

e) reorienting the cusps and commissures of the aortic valve so that the aortic valve has a diameter of from about 16 millimeters to about 27 millimeters.

35. A system for the repair of an aortic valve comprising:

a mounting frame comprising

three curvatures with each of the curvatures curved in a first plane and curved in a second plane;

three points interconnecting the three curvatures; and

posts extending upward from the three points;

buttressing elements; and

sutures.

36. The system of claim 35 wherein the buttressing elements are felt pledgets.

37. The system of claim 35 wherein the buttressing elements are support arcs similar in shape to the three curvatures of the frame.

38. A method of selecting a size of an intra-annular hemispherical mounting frame for implantation into an aortic valve, comprising the steps of:

a) determining at least one measurement of an aortic valve; and

b) selecting an appropriately-sized intra-annular hemispherical mounting frame using the at least one measurement of the aortic valve.

39. The method of claim 38 wherein step b) further comprises using the at least one measurement of the aortic valve and a hemispherical mathematical model of the aortic valve to select an appropriately sized intra-annular mounting frame.

40. The method of claim 38 wherein step a) further comprises using a non-invasive imaging technique in determining at least one measurement of the aortic valve.

41. The method of claim 40 wherein the non-invasive imaging technique comprises magnetic resonance imaging.

42. The method of claim 40 wherein the non-invasive imaging technique comprises echocardiography.

43. The method of claim 40 wherein step b) further comprises using a control system with preset conditions with the imaging technique for generating output of at least one appropriately-sized intra-annular hemispherical mounting frame based at least one measurement of the aortic valve.

44. The method of claim 43 wherein the preset conditions of the imagining technique include mathematical representations of the hemispherical mathematical model of the aortic valve.