Non-axisymmetric aortic valve devices

• US 9,161,835 B2
• Filed: 03/26/2012
• Issued: 10/20/2015
• Est. Priority Date: 09/30/2010
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc)
• Original Assignee: BioStable Science & Engineering, Inc.
• Inventors: Rankin, J. Scott, Beavan, Al, Cohn, William E.
• Primary Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US13/430,642
• Publication Number:
  US 20120239143A1
• Time in Patent Office: 1,303 Days
• Field of Search: 623/1.24, 623/1.26, 623 21- 219
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/2463 Implants forming part of the valve leaflets
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0063 Three-dimensional shapes
• CPC Class Codes: A61F 2250/0087 colour-coded

Abstract

The present disclosure provides aortic valve prosthetic devices that are constructed in a non-axisymmetric shape, or are expandable to a non-axisymmetric shape for improved results in the repair of defective aortic valves. The devices can be surgically implanted, or they can be implanted percutaneously through an insertion catheter. The expandable devices can be self-expanding or expanded by an inflatable balloon to a non-axisymmetric cross-section geometry.

Claims

1. A non-axisymmetric device for implantation into a native aortic valve of a mammal comprising a non-axisymmetric cross-sectional shape, a base and commissure support members attached to the base, wherein the members flare outwardly from the base at an angle of from about 1°

to about 30°

from a line perpendicular to the outer edge of the non-axisymmetric cross-sectional shape.

2. The device of claim 1, wherein the device comprises an elliptical cross-sectional shape.

3. The device of claim 1, wherein the members flare outwardly from the base at an angle of from 8°

-12°

from a line perpendicular to the outer edge of the non-axisymmetric cross-sectional shape.

4. The device of claim 1, wherein the members extend away from the base at an outward angle of about 10°

from a line perpendicular to the outer edge of the elliptical cross-section.

5. The device of claim 1, wherein the non-axisymmetric cross-sectional shape has a major axis and a minor axis, and wherein the ratio of the major axis to the minor axis is between about 1.1 and 1.8.

6. The device of claim 5, wherein the ratio of the major axis to the minor axis is about 1.5.

7. The device of claim 1, wherein the non-axisymmetric cross-sectional shape has a major axis having a length between about 10 millimeters and about 35 millimeters.

8. The device of claim 1, wherein the non-axisymmetric cross-sectional shape has a minor axis having a length between about 8 millimeters and about 25 millimeters.

9. The device of claim 1, wherein the device is non-axisymmetrically constructed.

10. The device of claim 9, wherein the device comprises at least two different materials.

11. The device of claim 9, wherein the device comprises at least two different thicknesses of a material.

12. The device of claim 1, wherein the device comprises a plastic, a polymer, a metal, a thermoplastic, a resin, or combinations thereof.

13. The device of claim 12, wherein the device comprises metal.

14. The device of claim 13, wherein the device comprises metal wire.

15. The device of claim 1, wherein the device comprises animal tissue.

16. The device of claim 1, wherein at least a portion of the device is coated or covered.

17. The device of claim 16, wherein at least a portion of the device is coated or covered with a polymer cloth.

18. The device of claim 1, wherein the device is constructed of a compressible and expandable material effective to be compressible into a percutaneous delivery system and expandable to a non-axisymmetric geometry when released.

19. The device of claim 18, wherein the device is expandable to an elliptical geometry when released.

20. The device of claim 18, wherein the device is self-expanding.

21. The device of claim 20, wherein the device comprises Nitinol.

22. The device of claim 1, wherein the device avoids or reduces pressure on the atrioventricular node when placed into the aortic valve region.

23. The device of claim 1, wherein the device is a non-axisymmetric valve prostheses.