Heart valve prosthesis

• US 10,206,775 B2
• Filed: 02/07/2014
• Issued: 02/19/2019
• Est. Priority Date: 08/13/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kovalsky, Igor, Garde, Kshitija, Lo, Pham, Quill, Jason, Savage, Padraig
• Primary Examiner(s): Baria, Dinah
• Application Number:
  US14/175,100
• Publication Number:
  US 20140222142A1
• Time in Patent Office: 1,838 Days
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2457 Chordae tendineae prostheses
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0058 soldered or brazed or welded
• 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 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0071 breakable or frangible

Abstract

Heart valve prosthesis are disclosed that include a frame or support structure having an inflow portion, a valve-retaining tubular or central portion and a pair of support arms. The inflow portion radially extends from a first end of the valve-retaining tubular portion and the pair of support arms are circumferentially spaced apart and radially extend from an opposing second end of the valve-retaining tubular portion.

Claims

1. A valve prosthesis for implantation into a native valve site, the valve prosthesis comprising:

a valve body; and

a frame comprising,

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

an inflow portion configured to engage an upstream side of the annulus and restrict movement of the valve prosthesis in a downstream direction of blood flow at the native valve site, and

a support arm configured to engage one or more structures of the native valve site and restrict movement of the valve prosthesis in an upstream direction of blood flow at the native valve site, the support arm having a curved U shape with side segments connected to the central portion and a curved middle segment extending between the side segments, the middle segment spaced radially outward from the central portion when the valve prosthesis is in a deployed configuration; and

a chordae engagement element extending from the support arm of the frame and configured to engage chordae of the native valve site, wherein the chordae engagement element has a tent portion that forms a taut pocket spaced apart from the support arm and the central portion of the frame, the taut pocket generally radially extending from the middle segment of the support arm to the central portion of the frame when the valve prosthesis is in the deployed configuration, wherein the taut pocket is configured to allow the chordae to rest thereon such that the chordae are spaced apart from the support arm and the frame when resting on the taut pocket and the chordae interact only with the taut pocket without contacting the frame or the support arm when resting on the taut pocket, and wherein the tent portion includes a rectangular or diamond-shaped flap attached to the frame, wherein the rectangular or diamond-shaped flap includes at least two edges circumferentially spaced apart on the frame and is attached to the central portion to cover only a portion of a circumference of an outer surface thereof, to prevent the flap from bending and flexing and thereby cause the taut pocket to be taut such that the taut pocket during engagement with the chordae remains spaced apart from the support arm and the central portion of the frame.

2. The valve prosthesis of claim 1, wherein the support arm is configured to engage a native valve leaflet and the chordae engagement 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 engagement element is configured to reduce bending of the chordae to reduce stress on the chordae during a cardiac cycle.

3. The valve prosthesis of claim 1, wherein the inflow portion includes an extension that protrudes in a substantially 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.

4. The valve prosthesis of claim 1, wherein the inflow portion comprises a substantially s-shaped portion.

5. The valve prosthesis of claim 1, wherein the inflow portion comprises a substantially saddle shaped portion.

6. The valve prosthesis of claim 1, wherein the inflow portion is formed from a plurality of struts that extend outwardly with adjacent struts of the plurality of struts being joined and wherein each strut of the plurality of struts has a substantially s-shaped profile.

7. The valve prosthesis of claim 1, further comprising one or more fixation elements.

8. The valve prosthesis of claim 1, wherein the tent portion is formed from a material selected from the group consisting of a native valve tissue, an artificial valve tissue, a fabric, a mesh, and an elastic material.

9. The valve prosthesis of claim 1, wherein the tent portion is attached to at least one of the support arm and the central portion via sutures.

10. The valve prosthesis of claim 1, wherein a gap is created by the tent portion between the central portion of the frame and the support arm of the frame.

11. The valve prosthesis of claim 1, wherein the rectangular or diamond-shaped flap is rectangular and includes four corners that are spaced apart on the frame.

12. The valve prosthesis of claim 1, wherein the rectangular or diamond-shaped flap extends lateral of each of the side segments of the support arm.

13. A prosthetic valve comprising:

an annular frame configured to fit within an annulus of a native valve site;

a support arm configured to engage one or more structures of the native valve site and extending radially outward from the annular frame; and

a chordae engagement element configured to engage chordae of the native valve site, wherein the chordae engagement element extends from the support arm to the annular frame when the prosthetic valve is in a deployed configuration, and wherein the chordae engagement element is configured to allow the chordae to rest thereon such that the chordae are spaced apart from the support arm and the annular frame when resting on the chordae engagement element and the chordae interact only with the chordae engagement element without contacting the annular frame or the support arm and wherein the chordae engagement element includes a rectangular or diamond-shaped flap attached to the annular frame to prevent the flap from bending and flexing and thereby cause the chordae engagement element to be taut, the rectangular or diamond-shaped flap including at least two edges spaced apart on the annular frame to cover only a portion of a circumference an outer surface thereof.

14. The prosthetic valve of claim 13, wherein the rectangular or diamond-shaped flap is rectangular and includes four corners that are spaced apart on the annular frame.

15. The prosthetic valve of claim 13, wherein the support arm is a curved U shape with side segments and a middle segment extending between the side segments and wherein the rectangular or diamond-shaped flap extends lateral of each of the side segments of the support arm.