SYSTEMS AND METHODS FOR REPLACING A NATIVE HEART VALVE AND AORTA WITH A PROSTHETIC HEART VALVE AND CONDUIT

• US 20140088692A1
• Filed: 09/20/2013
• Published: 03/27/2014
• Est. Priority Date: 09/25/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Wright, Gregory A.
• Granted Patent: US 9,585,748 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• 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 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

Abstract

A medical device includes an expandable conduit, a prosthetic heart valve and a delivery device, including a balloon catheter. The expandable conduit may include one or more inner or outer sleeves supported by a frame or stent. The sleeve(s) may be a bioprosthetic tissue wrapped, molded or sewn about the frame or stent. Coupled to an end of the expandable conduit is the prosthetic heart valve. The conduit and heart valve may be crimped on the balloon catheter for percutaneous deployment. The frame may be constructed of a balloon-expandable material for the conduit portion and a self-expandable material for the prosthetic heart valve portion. The prosthetic heart valve is anchored at the native heart valve and then the conduit to be expanded into place to protect the aorta. The self-expanding prosthetic heart valve avoids the need for balloon mounting. This provides for a smaller diameter and easier delivery.

Claims

1. A medical device for use in a heart having a native heart valve and a vessel extending from the native heart valve, the medical device comprising:

a balloon-expandable conduit; and

a prosthetic valve coupled to an end of the balloon-expandable conduit,

wherein the prosthetic valve comprises a self-expandable material configured to expand in a radially outward direction to frictionally engage at least a portion of the native heart valve and inhibit axial movement of the prosthetic valve and the balloon-expandable conduit relative to the native heart valve.

2. The medical device of claim 1, wherein the balloon-expandable conduit includes a balloon-expandable tubular frame and a sleeve extending axially along and against the balloon-expandable frame.

3. The medical device of claim 2, wherein the self-expandable material of the prosthetic valve includes a self-expandable tubular frame and the prosthetic valve includes valve leaflets supported within the self-expandable tubular frame.

4. The medical device of claim 3, wherein the balloon-expandable tubular frame and self-expandable tubular frame are contiguously formed of a nitinol alloy.

5. The medical device of claim 4, wherein the self-expandable tubular frame has an expanded memory shape.

6. The medical device of claim 5, wherein the prosthetic valve further comprises an annular ring of a woven material coupling the valve leaflets to the self-expandable tubular frame.

7. The medical device of claim 2, wherein the sleeve includes a bioprosthetic tissue.

8. The medical device of claim 7, wherein the sleeve extends along an inner diameter surface of the balloon-expandable tubular frame.

9. The medical device of claim 7, wherein the bioprosthetic tissue is selected from a group consisting of a bovine pericardium, a porcine pericardium, and an allogenic/autogenic collagen matrix tissue.

10. The medical device of claim 9, wherein the bioprosthetic tissue is glycerolized to facilitate dry storage.

11. The medical device of claim 2, wherein the sleeve includes at least one of a polymer or gel coatings.

12. The medical device of claim 1, further comprising a retractable sheath, the retractable sheath defining an interior portion into which at least the prosthetic valve is compressed radially inwardly.

13. The medical device of claim 12, wherein the retractable sheath comprises at least one radiopaque marker on an outer surface of the retractable sheath.

14. The medical device of claim 2, wherein the balloon-expandable tubular frame comprises a plastically deformable metal material.

15. The medical device of claim 1, further comprising one or more anchors that extend outwardly from at least one of the balloon-expandable conduit or the prosthetic valve.

16. The medical device of claim 15, wherein the one or more anchors comprise a tissue irritation structure to induce tissue ingrowth.

17. The medical device of claim 16, wherein the tissue irritation structure includes at least one of a fenestration or a dimple.

18. The medical device of claim 15, wherein the one or more anchors are circumferentially spaced apart about an outer surface of the medical device and extend radially outwardly.

24. The medical device of claim 1, further comprising a catheter with a balloon disposed inside the balloon expandable conduit.

19. A method, comprising:

delivering a balloon-expandable conduit coupled to a self-expandable prosthetic heart valve into a vessel extending from a native heart valve and the self-expandable prosthetic heart valve into the native heart valve;

inflating a balloon disposed within the balloon-expandable conduit such that an outer surface of the balloon-expandable conduit is urged substantially toward the vessel; and

expanding the self-expandable prosthetic heart valve within or near the native heart valve by axially moving a retractable sheath away from an outer surface of the self-expandable prosthetic heart valve.

20. The method of claim 19, further comprising engaging at least one of the vessel or native heart valve with one or more anchors coupled to at least one of the conduit or prosthetic heart valve.

21. A method comprising:

coupling a self-expandable prosthetic heart valve adjacent a balloon-expandable conduit;

disposing a balloon and balloon catheter within an interior portion of the balloon-expandable conduit;

compressing the balloon-expandable conduit and the prosthetic valve radially inwardly; and

disposing at least the self-expandable prosthetic valve into an interior portion of a retractable sheath.

22. The method of claim 21, wherein coupling the self-expandable prosthetic heart valve adjacent the balloon-expandable conduit includes forming a contiguous frame, coupling a bioprosthetic sleeve to at least one end of the frame and valve leaflets to the other end of the frame.

23. The method of claim 22, further comprising forming the other end of the frame to have an expanded memory shape.