HEART VALVE

• US 20100082094A1
• Filed: 09/29/2009
• Published: 04/01/2010
• Est. Priority Date: 09/29/2008
• Status: Active Grant

• Current Assignee: Edwards Lifesciences CardiAQ LLC (Edwards Lifesciences Corporation)
• Original Assignee: Cardiaq Valve Technologies Incorporated
• Inventors: Ratz, J. Brent, Quadri, Arshad
• Granted Patent: US 8,403,983 B2
• Time in Patent Office: Days
• US Class Current: 623/1.260
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2412 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 2/2415 Manufacturing methods
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/848 having means for fixation to the vessel wall, e.g. barbs
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/8486 provided on at least one of the ends
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• 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 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: Y10T 29/49426 including metal shaping and diverse operation

Abstract

A heart valve includes a valve body made of a flexible material such as pericardium. The valve body is made of two layers of material, an outer layer, and an inner layer that defines a plurality of leaflets. The leaflets of the inner layer are attached to the outer layer. In some embodiments the valve body is made by cutting a single piece of flat source tissue, folding the cut tissue and forming it into a tubular pattern having the inner and outer layers. The multi-layer valve body can be mounted on a stent for delivery within a patient'"'"'s heart.

Claims

1. A replacement heart valve, comprising:

A valve body comprising an outer layer and an inner layer;

The outer layer being tubular and having a longitudinal axis, an upstream end and a downstream end, the outer layer formed from a thin, flexible material;

The inner layer being generally tubular, having a longitudinal axis generally collinear with the outer layer, and being positioned within the tubular outer layer, the inner layer formed from a thin, flexible material and defining a plurality of leaflets adapted to move between an open state and a coapted state, each leaflet having a side edge and a downstream portion, adjacent leaflets of the inner layer being connected by a commissural portion;

wherein the leaflets are attached to the outer layer along the leaflet side edges, and the commissural portions are attached to the outer layer downstream of at least a portion of the leaflet side edges;

2. A replacement heart valve as in claim 1, wherein the inner and outer layers are constructed from a single, contiguous section of the flexible material.

3. A replacement heart valve as in claim 2, wherein the inner and outer layers are folded relative to one another at the upstream end so that the inner layer is contiguous with the outer layer at the upstream end.

4. A replacement heart valve as in claim 1, wherein the outer layer comprises a commissural slit, and an edge of one of the commissural portions of the inner layer extends at least partially through the slit.

5. A replacement heart valve as in claim 4, wherein the outer layer comprises a leaflet slit shaped to complement a corresponding leaflet side edge, and the leaflet side edge extends at least partially through the slit.

6. A replacement heart valve as in claim 1, wherein the outer layer has a plurality of windows formed therethrough, the windows configured so that, when the leaflets are in the coapted state, blood readily flows through the windows.

7. A replacement heart valve as in claim 1 additionally comprising an elongate stent that can be radially compacted to a compacted state and radially expanded to an expanded state, the stent having a longitudinal axis, and wherein the valve body is attached to the stent.

8. A replacement heart valve as in claim 7, wherein the outer layer is on an outer side of the stent and the inner layer is on an inner side of the stent so that the stent is sandwiched between the inner and outer layers.

9. A replacement heart valve as in claim 7, wherein the valve body is positioned so that the stent is adjacent an outer surface of the outer layer.

10. A replacement heart valve as in claim 9, wherein the outer layer of the valve body is connected to the stent, and the inner layer of the valve body is directly connected to the inner layer, but is not directly connected to the stent.

11. A replacement heart valve as in claim 9, wherein when the leaflets are in an open position, the outer layer is interposed between the open leaflets and the stent.

12. A replacement heart valve as in claim 7, wherein the stent has a foreshortening portion, the foreshortening portion configured so that as the stent is radially compacted, the foreshortening portion longitudinally expands, and as the stent is radially expanded, the foreshortening portion longitudinally contracts.

13. A replacement heart valve as in claim 12, wherein at least a portion of the valve body is disposed at least partially within the foreshortening portion, and the valve body is attached to the stent at one or more connecting points, which connecting points are generally aligned with an axial point along the stent longitudinal axis, so that during foreshortening the stent longitudinally moves relative to the valve body without longitudinally stretching or crushing the valve body.

14. A replacement heart valve as in claim 13 additionally comprising a longitudinally expandable material that is directly connected to the stent and to the valve body, the flexible material directly connected to the stent at one or more connection points that are longitudinally spaced from the axial point.

15. A replacement heart valve as in claim 12, wherein the stent additionally comprises a non-foreshortening portion, and the valve body is maintained within the non-foreshortening portion.

16. A method of making a replacement heart valve, comprising:

providing a flat, flexible source material;

cutting the flat material according to a desired pattern, the pattern defining first and second pattern ends, a skirt portion, and a leaflet portion, the leaflet portion defining a plurality of leaflets, commissures extending between adjacent leaflets, and each leaflet having side edges;

adjoining the first and second pattern ends so as to form the flat material into a tube;

folding the leaflet portion relative to the skirt portion along a fold line so that the leaflet portion is generally within the skirt portion;

attaching the commissures to the skirt portion; and

attaching the leaflet side edges to the skirt portion.

17. A method of making a replacement heart valve as in claim 16 additionally comprising providing a form having a shape that is substantially the negative of a desired shape of the valve in a closed state, the form having leaflet shaping portions, and after the flat material has been formed into a tube and the commissures attached to the skirt portion, placing the valve upon the form so that the leaflets engage the leaflet shaping portions, and attaching the leaflet side edges to the skirt portion when the leaflets are engaged with the leaflet shaping portions.

18. A method of making a replacement heart valve as in claim 17 additionally comprising forming leaflet slits in the skirt portion, the leaflet slits generally corresponding the a desired curvature of the leaflets, and placing the valve upon the form so that the leaflets engage the leaflet shaping portions comprises extending the leaflet side edges through the leaflet slits in the skirt portion.

19. A method of making a replacement heart valve as in claim 16 additionally comprising providing an elongate stent, and attaching the skirt portion to the stent.

20. A method of treating valve insufficiency of a patient by delivering a replacement heart valve, comprising:

providing a replacement heart valve comprising a valve body attached to a stent, the valve body having an upstream end and a plurality of leaflets adapted to open and close, the leaflets each having a downstream portion, the stent being elongate and having an upstream end, a downstream end, and a longitudinal midpoint halfway between the upstream and downstream ends, the stent having an annulus attachment zone adapted to engage a native valve annulus, the annulus attachment zone disposed at or adjacent the downstream end of the stent;

positioning the heart valve within a patient'"'"'s heart so that the annulus attachment zone of the stent engages a patient'"'"'s mitral annulus, and the longitudinal midpoint of the stent is disposed within the patient'"'"'s left atrium.

21. A method of treating valve insufficiency as in claim 20, wherein positioning the heart valve comprises positioning the valve so that substantially all of the stent is disposed in the patient'"'"'s mitral annulus or left atrium.

22. A method of treating valve insufficiency as in claim 20, wherein the valve body is connected to the stent so that the downstream ends of the leaflets are within the left atrium.

23. A method of treating valve insufficiency as in claim 20, wherein the valve body is connected to the stent so that the downstream ends of the leaflets are disposed generally within the mitral annulus.