PROSTHETIC HEART VALVE

• US 20150320556A1
• Filed: 05/05/2015
• Published: 11/12/2015
• Est. Priority Date: 05/12/2014
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Levi, Tamir S., Sharoni, Ron, Nguyen, Son V., Sherman, Elena, Wintner, Oren H., Rupp, Kevin D., Chadha, Ajay, Lindstrom, Jeff
• Granted Patent: US 10,195,025 B2
• Time in Patent Office: Days
• 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• 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 2230/0019 rectangular
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61F 2250/0069 Sealing means
• CPC Class Codes: Y10T 29/49927 Hollow body is axially joined cup or tube

Abstract

Embodiments of a radially collapsible and expandable prosthetic heart valve are disclosed. The prosthetic valve can comprise an annular frame, leaflets, an inner skirt, and an outer skirt. The outer skirt can be secured to the outside of the inflow end portion of the frame, the outer skirt having longitudinal slack that buckles outward radially when the valve is in the expanded configuration and which lies flat when the valve is in the collapsed configuration. In some embodiments, the outer skirt is stiffer in the axial direction of the valve than in the circumferential direction of the valve. In additional embodiments, the outer skirt comprises a self-expandable fabric comprising fibers made of a shape memory material having a shape memory set to enhance the radially outward buckling of the outer skirt. Methods of crimping such valves to a collapsed or partially collapsed configuration are also disclosed.

Claims

1. An implantable prosthetic valve comprising:

an annular frame comprising an inflow end and an outflow end and being radially collapsible and expandable between a radially collapsed configuration and a radially expanded configuration, the frame defining an axial direction extending from the inflow end to the outflow end;

a leaflet structure positioned within the frame and secured thereto; and

an annular outer skirt positioned around an outer surface of the frame, wherein the outer skirt comprises;

an inflow edge secured to the frame at a first location,

an outflow edge secured to the frame at a second location;

an intermediate portion between the inflow edge and the outflow edge that comprises slack that buckles radially outwards from the inflow and outflow edges of the annular outer skirt when the valve is in the expanded configuration; and

(a) a fabric that is stiffer in the axial direction of the valve compared to a circumferential direction to enhance the radial outward buckling of the slack; and

/or

(b) a self-expandable fabric comprising fibers made of shape memory material having a shape memory set to enhance the radially outward buckling of the slack of the outer skirt.

2. The valve of claim 1, wherein the outflow edge of the outer skirt comprises a plurality of alternating projections and notches, the projections secured to the frame at the second location, the notches not directly secured to the frame.

3. The valve of claim 1, wherein when the frame is in the collapsed configuration, the axial distance between the inflow edge of the outer skirt and the outflow edge of the outer skirt is greater than when the valve is in the expanded configuration, reducing the slack in the intermediate portion of the outer skirt.

4. The valve of claim 1, wherein the fabric comprises fibers that do not comprise residual strain after the frame is expanded to the expanded configuration from the collapsed configuration.

5. The valve of claim 1, wherein the annular outer skirt comprises the fabric that is stiffer in the axial direction of the valve compared to a circumferential direction, and wherein the fabric comprises:

a plurality of first fibers parallel to the axial direction of the frame; and

a plurality of second fibers perpendicular to the plurality of first fibers; and

wherein at least some of the fibers in the plurality of first fibers are stiffer than the fibers in the plurality of second fibers.

6. The valve of claim 5, wherein the plurality of first fibers comprises monofilament fibers.

7. The valve of claim 5, wherein the plurality of second fibers comprises microfilament fibers, multifilament fibers, or a combination of microfilament fibers and multifilament fibers.

8. The valve of claim 5, wherein the plurality of second fibers comprises fibers that do not comprise residual strain after the frame is expanded to the expanded configuration from the collapsed configuration.

9. The valve of claim 1, wherein the self-expandable fabric comprises a weave of warp fibers and weft fibers.

10. The valve of claim 9, wherein the weft fibers comprise the fibers made of shape memory material.

11. The valve of claim 9, wherein the weave of warp fibers and weft fibers comprises:

a plain weave pattern comprising fibers made of non-shape memory material; and

a satin weave pattern comprising the fibers made of the shape memory material.

12. The valve claim 11, wherein the satin weave pattern comprises warp fibers made of non-shape memory material and weft fibers made of the shape memory material.

13. The valve of claims 1, wherein the shape-memory material is a nickel titanium alloy.

14. The valve of claim 1, wherein the fibers made of shape memory material comprise a diameter of from 0.5 to 15 Mils.

15. The valve of claim 1, wherein the annular frame comprises a plurality of leaflet attachment portions;

and the leaflet structure is secured to the leaflet attachment portions of the frame.

16. An assembly for implanting a prosthetic heart valve in a patient'"'"'s body comprising:

a delivery apparatus comprising an elongated shaft; and

the prosthetic heart valve of claim 1 mounted on the shaft in a radially collapsed configuration for delivery into the body.

17. A method of radially compressing a prosthetic valve, comprising:

partially inserting the valve while in a radially expanded configuration into a crimping device comprising crimping jaws, wherein a portion of the valve comprising an outer skirt extends outside of the crimper jaws;

crimping the valve to a first partially collapsed configuration;

further inserting the valve into the crimping device, such that the outer skirt is between the crimper jaws;

crimping the valve to a second partially collapsed configuration; and

optionally crimping the valve to a fully crimped configuration.

18. The method of claim 17, comprising crimping the valve to the fully crimped configuration.

19. The method of claim 17, wherein

(a) the valve in the first partially collapsed configuration comprises a diameter that is about 60% of the diameter of the valve in the expanded configuration;

(b) the valve in the second partially collapsed configuration comprises a diameter that is about 40% of the diameter of the valve in the expanded configuration;

(c) the valve in the fully collapsed configuration comprises a diameter that is about 10% of the diameter of the valve in the expanded configuration;

or

(d) a combination of two or more of (a)-(c).

20. The method of claim 17, wherein the crimping device is an automated crimping device.