Non-axisymmetric aortic valve devices
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.
1. A device for implantation into a native aortic valve of a mammal comprising: a geometrical cross-sectional shape that is not superimposable on itself more than twice during a 360 degree rotation, 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 geometrical shape.
2. The device of claim 1 , wherein the device comprises a non-axisymmetric cross-sectional shape.
3. The device of claim 2 , wherein the device comprises an elliptical cross-sectional shape.
4. 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 geometrical shape.
5. The device of claim 4 , 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 geometrical shape.
6. The device of claim 1 , wherein the geometrical shape comprises a major axis and a minor axis, and wherein the ratio of the major axis of the ellipse to the minor axis of the ellipse is between about 1.1 and 1.8.
7. The device of claim 6 , wherein the ratio of the major axis to the minor axis of the ellipse is about 1.5.
8. The device of claim 6 , wherein the length of the major axis of the elliptical cross-section is between about 10 millimeters and about 35 millimeters.
9. The device of claim 6 , wherein the length of the minor axis of the elliptical cross-section is between about 8 millimeters and about 25 millimeters.
10. The device of claim 1 , wherein the device is non-axisymmetrically constructed.
11. The device of claim 1 , wherein the device comprises at least two different materials.
12. The device of claim 1 , wherein the device comprises at least two different thicknesses of a material.
13. The device of claim 1 , wherein the device comprises a plastic, a polymer, a metal, a thermoplastic, a resin, or combinations thereof.
14. The device of claim 13 , wherein the device comprises metal.
15. The device of claim 14 , wherein the device comprises metal wire.
16. The device of claim 1 , wherein the device comprises animal tissue.
17. The device of claim 1 , wherein at least a portion of the device is coated or covered.
18. The device of claim 17 , wherein at least a portion of the device is coated or covered with a polymer cloth.
19. 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 the geometrical shape when released.
20. The device of claim 19 , wherein the device is expandable to an elliptical geometry when released.
21. The device of claim 19 , wherein the device is self-expanding.
22. The device of claim 21 , wherein the device comprises a nickel-titanium alloy.
23. The device of claim 1 , wherein the device avoids or reduces pressure on the atrioventricular node when placed into the aortic valve region.
24. The device of claim 1 , wherein the device is a valve prosthesis.