Valve prosthesis and method for delivery

• US 9,232,995 B2
• Filed: 01/08/2013
• Issued: 01/12/2016
• 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, Hariton, Ilia, Tuval, Yossi, Yellin, Nadav
• Primary Examiner(s): DUKERT, BRIAN AINSLEY
• Application Number:
  US13/736,460
• Publication Number:
  US 20140194982A1
• Time in Patent Office: 1,099 Days
• Field of Search: 623/1.26, 623 217- 219, 623/2.38
• US Class Current: 1/1
• 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;

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

a pair of support arms extending from the central portion and configured to extend over and secure a respective native valve leaflet; and

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 includes a plurality of extensions that protrude in an overall radially outward direction from the frame to circumferentially surround the central portion of the frame,

wherein each of the plurality of extensions 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, wherein first and second curves of the plurality of extensions provide the inlet portion with an s-shape that permits the inlet portion to deform upon implantation and to act in opposition with the pair of support arms to create a seal with the floor of the outflow tract of the native heart atrium after implantation.

2. 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.

3. 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.

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

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

6. 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 inwardly extending from the support arm to be disposed between the support arm and the central portion and configured to engage chordae of the valve site when the frame is expanded,

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.

7. The valve prosthesis of claim 6, 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.

8. The valve prosthesis of claim 6, wherein an outflow end of the support arm is longitudinally offset from an outflow end of the chordae guiding element such that the outflow end of the support arm is closer to an outflow end of the frame than the outflow end of the chordae guiding element.

9. The valve prosthesis of claim 8, 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.

10. The valve prosthesis of claim 6, wherein an outflow end of the support arm is laterally offset from an outflow end of the chordae guiding element.

11. The valve prosthesis of claim 6, 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.

12. The valve prosthesis of claim 6, wherein the support arm is coated with a biocompatible polymer.

13. The valve prosthesis of claim 6, wherein the support arm is coated with expanded polytetrafluoroethylene.

14. The valve prosthesis of claim 6, wherein the frame further comprises:

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

15. The valve prosthesis of claim 14, wherein the frame further comprises:

a second chordae guiding element connected to the second support arm to inwardly extend from the second support arm such that the second chordae guiding element is disposed between the second support arm and the central portion when the frame is expanded.

16. The valve prosthesis of claim 6, wherein the frame further comprises:

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.

17. The valve prosthesis of claim 6, 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.

18. 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 directly attached to the support arm, the chordae guiding element extending radially outward from the support arm and being configured to engage chordae of the valve site when the frame is expanded, wherein a first end and a second end of the chordae guiding element are both directly attached to the support arm,

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.