Heart Valve Prosthesis

• US 20140222142A1
• Filed: 02/07/2014
• Published: 08/07/2014
• Est. Priority Date: 08/13/2012
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kovalsky, Igor, Bergin, Cathleen, Creaven, Marian, Dwork, Joshua, Glozman, Daniel, Hariton, Ilia, Savage, Padraig, Schendel, Michael, Tuval, Yossi, Garde, Kshitija, Lo, Pham, Quill, Jason, Sandstrom, Jeffrey, Schotzko, Elizabeth, Yellin, Nadav
• Granted Patent: US 10,206,775 B2
• Time in Patent Office: Days
• US Class Current: 623/2.17
• 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.

2. The valve prosthesis of claim 1, wherein the frame further comprises:

the support arm being configured to engage a native valve leaflet; and

a chordae engagement element extending from the support arm and configured to engage chordae of the native valve site, wherein 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 2, wherein a first end of the chordae engagement element is attached to the support arm and a second end of the chordae engagement element is attached to the central portion.

4. The valve prosthesis of claim 2, wherein a first end and a second end of the chordae engagement element are each attached to the support arm.

5. The valve prosthesis of claim 1, wherein the central portion comprises a chordae engagement element configured to engage chordae of the native valve site, wherein 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.

6. The valve prosthesis of claim 1, wherein the support arm is configured to engage a native valve leaflet and wherein the support arm translates between 135 degrees and 180 degrees from a delivery configuration to a deployed configuration.

7. The valve prosthesis of claim 1, wherein the support arm is configured to engage the annulus of the native valve site and wherein the support arm translates between 135 degrees and 180 degrees from a delivery configuration to a deployed configuration.

8. The valve prosthesis of claim 1, wherein the support arm is configured to engage a commissure of the native valve site and wherein the support arm translates between 135 degrees and 180 degrees from a delivery configuration to a deployed configuration.

9. The valve prosthesis of claim 1, wherein the support arm is configured to engage chordae of the native valve site and wherein the support arm translates between 135 degrees and 180 degrees from a delivery configuration to a deployed configuration.

10. The valve prosthesis of claim 1, 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 native valve site.

11. The valve prosthesis of claim 10, wherein the hourglass shape is located on the central portion corresponding to a location of a commissure of the native valve site.

12. The valve prosthesis of claim 10, wherein the hourglass shape is located on the central portion around the entire circumference of the frame.

13. The valve prosthesis of claim 1, wherein the frame includes a portion having a substantially elliptical cross-section.

14. The valve prosthesis of claim 1, wherein the frame includes a portion having a substantially triangular cross-section.

15. 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.

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

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

18. 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 and at least one twisted area.

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

20. The valve prosthesis of claim 1, wherein the support arm has an acute configuration and a chronic configuration.

21. The valve prosthesis of claim 1, wherein the inflow portion comprises a support arm having an acute configuration and a chronic configuration.

22. The valve prosthesis of claim 1, wherein the inflow portion comprises one or more support arms selected from the group consisting of leaflet engagement support arms, annulus engagement support arms, commissural engagement support arms, chordae engagement support arms, ventricle engagement support arms, atrium engagement support arms, pulmonary artery engagement support arms, and aorta engagement support arms.

23. The valve prosthesis of claim 1, wherein the central portion comprises one or more support arms selected from the group consisting of leaflet engagement support arms, annulus engagement support arms, commissural engagement support arms, chordae engagement support arms, ventricle engagement support arms, atrium engagement support arms, pulmonary artery engagement support arms, and aorta engagement support arms.

24. The valve prosthesis of claim 1, wherein the support arm comprises one or more support arms selected from the group consisting of leaflet engagement support arms, annulus engagement support arms, commissural engagement support arms, chordae engagement support arms, ventricle engagement support arms, atrium engagement support arms, pulmonary artery engagement support arms, and aorta engagement support arms.

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

a valve body; and

a frame comprising,

a central portion supporting the valve body, the central portion comprising an hourglass shaped portion,

an inflow portion comprising a saddle shaped portion and a strut that extends in a substantially radially outward direction from the central portion, the strut having a substantially s-shaped portion,

a leaflet engagement support arm, and

a chordae engagement element.