Valve Prosthesis and Method for Delivery

• US 20140194982A1
• Filed: 01/08/2013
• Published: 07/10/2014
• Est. Priority Date: 01/08/2013
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kovalsky, Igor, Quill, Jason, Glozman, Daniel, Tuval, Yossi, Yellin, Nadav, Hariton, Ilia
• Granted Patent: US 9,232,995 B2
• Time in Patent Office: Days
• US Class Current: 623/2.38
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2230/001 Figure-8-shaped, e.g. hourglass-shaped
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

In some embodiments, a valve prosthesis includes an inlet portion that is substantially s-shaped and configured to engage the floor of the outflow tract of the native heart atrium. In some embodiments, a valve prosthesis includes a chordae guiding element configured to reduce bending of the chordae to reduce stress on the chordae during the cardiac cycle. In some embodiments, a valve prosthesis includes a central portion having an hourglass shape configured to pinch a native annulus in order to provide axial fixation of the valve prosthesis within a valve site. In some embodiments, a valve prosthesis includes a frame having an outflow end that is flared to provide a gap between an outflow end of the frame and an outflow end of prosthetic leaflets when the prosthetic leaflets are fully opened.

Claims

1. A valve prosthesis for implantation into a native cardiac valve site of an individual, the valve prosthesis comprising:

a valve body; and

a frame supporting the valve body, the frame comprising;

an inlet portion configured to engage the floor of the outflow tract of the native heart atrium and restrict movement of the valve prosthesis in a downstream direction of blood flow at the valve site;

wherein the inlet portion is substantially s-shaped.

2. The valve prosthesis of claim 1, wherein the inlet portion includes an extension that protrudes in a radially outward direction from the frame, bends in a first curve from an inflow end of the frame towards an outflow end of the frame, and then bends in a second curve towards the inflow end.

3. The valve prosthesis of claim 1, wherein the inlet portion is sized to contact the entire floor of the outflow tract and a portion of the atrial wall.

4. The valve prosthesis of claim 1, wherein at least a portion of the inlet portion has a flexibility from about 0.8 N/m to about 2 N/m.

5. The valve prosthesis of claim 1, wherein at least a portion of the inlet portion has a flexibility of about 1.25 N/m.

6. The valve prosthesis of claim 1, wherein the inlet portion is formed of twisted strands of nitinol.

7. A valve prosthesis for implantation into a native cardiac valve site of an individual, the valve prosthesis comprising:

a valve body; and

a frame supporting the valve body, the frame comprising;

a central portion configured to fit securely within an annulus of the valve site;

a support arm extending from the central portion and configured to extend over and secure a native valve leaflet; and

a chordae guiding element extending from the support arm and configured to engage chordae of the valve site,

wherein the chordae guiding element is configured to angle the chordae so that the chordae are stretched to restrict movement of the valve prosthesis in an upstream direction of blood flow at the valve site, and

wherein the chordae guiding element is configured to reduce bending of the chordae to reduce stress on the chordae during the cardiac cycle.

8. The valve prosthesis of claim 7, wherein the chordae guiding element is configured to position native chordae attached to the native leaflet such that the native chordae are not bent at an angle less than about 90 degrees.

9. The valve prosthesis of claim 7, wherein an outflow end of the support arm is longitudinally offset from an outflow end of the chordae guiding element.

10. The valve prosthesis of claim 9, wherein the offset between the outflow end of the support arm and the outflow end of the chordae guiding element is from about 1 mm to about 5 mm.

11. The valve prosthesis of claim 7, wherein an outflow end of the support arm is laterally offset from an outflow end of the chordae guiding element.

12. The valve prosthesis of claim 7, wherein the chordae guiding element is directly attached to the support arm and extends outward from the support arm.

13. The valve prosthesis of claim 7, wherein one end of the chordae guiding element is directly attached to the support arm and a second end of the chordae guiding element is directly attached to the central portion.

14. The valve prosthesis of claim 7, wherein a first end and a second end of the chordae guiding element are both attached to the frame.

15. The valve prosthesis of claim 7, wherein the support arm is coated with a biocompatible polymer.

16. The valve prosthesis of claim 7, wherein the support arm is coated with expanded polytetrafluoroethylene.

17. The valve prosthesis of claim 7, further comprising:

a second support arm connected to and extending from the central portion and configured to extend over and engage a second native valve leaflet.

18. The valve prosthesis of claim 17, further comprising a second chordae guiding element connected to the second support arm.

19. The valve prosthesis of claim 7, further comprising:

an inlet portion configured to engage the floor of the outflow tract of the native heart atrium and restrict movement of the valve prosthesis in a downstream direction of blood flow at the valve site.

29. The valve prosthesis of claim 7, wherein the chordae guiding element is configured to position native chordae attached to the native leaflet such that the native chordae are bent at an angle less than about 90 degrees.

20. A valve prosthesis for implantation into a native cardiac valve site of an individual, the valve prosthesis comprising:

a valve body; and

a frame supporting the valve body, the frame comprising;

a central portion configured to fit securely within an annulus of the native valve site,

wherein the central portion has an hourglass shape configured to pinch the annulus in order to provide axial fixation of the valve prosthesis within the valve site.

21. The valve prosthesis of claim 20, wherein the hourglass shape is located on the central portion corresponding to a location of the commissures of the native valve within the valve site.

22. The valve prosthesis of claim 20, wherein the hourglass shape is located on the central portion around the entire circumference of the frame,

23. The valve prosthesis of claim 20, wherein an outflow end of the valve body is substantially elliptical.

24. A valve prosthesis for implantation into a native cardiac valve site of an individual, the valve prosthesis comprising:

a valve body including prosthetic leaflets; and

a frame secured to the valve body, the frame comprising;

an inlet portion configured to engage the floor of an outflow tract of the native heart atrium and restrict movement of the frame in a downstream direction of blood flow at the valve site;

a central portion connected to the inlet portion and configured to fit securely within the native valve annulus,

wherein portions of the outflow end of the frame are flared to provide a gap between an outflow end of the frame and an outflow end of the prosthetic leaflets when the prosthetic leaflets are fully opened.

25. The valve prosthesis of claim 24, wherein the cross-section of the valve outlet is a rounded triangle with each vertex of the triangle aligned with a corresponding prosthetic leaflet of the valve body to provide the gap between the frame and the prosthetic leaflets,

26. The valve prosthesis of claim 24, wherein the sides of the rounded triangle curve inward.

27. The valve prosthesis of claim 24, wherein the mid-section of each side of the rounded triangle are aligned with a corresponding commissure of the valve body.

28. The valve prosthesis of claim 24, wherein the cross-section of the valve base is a rounded triangular and rotated about 60 degrees relative to the cross-section of the valve outlet so that the valve forms a roughly cylindrical shape.