Systems for replacing a native heart valve and aorta with a prosthetic heart valve and conduit

• US 10,307,248 B2
• Filed: 02/28/2017
• Issued: 06/04/2019
• Est. Priority Date: 09/25/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Wright, Gregory A.
• Primary Examiner(s): Eastwood, David C
• Assistant Examiner(s): Gabr, Mohamed G
• Application Number:
  US15/445,651
• Publication Number:
  US 20170165056A1
• Time in Patent Office: 826 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 2/2412 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 system for use in replacing a native aortic heart valve of a human and repairing a defect in a section of the aorta contiguous with the native aortic heart valve, the system comprising:

a catheter having a balloon thereon;

a retractable sheath defining an interior portion;

a medical device sleeved over the catheter, the medical device having a length sufficient to extend from a first end configured to be secured at the native aortic heart valve to a second end configured to be attached within and extending along the aorta at least as far as the aortic arch, the medical device comprising;

a self-expandable prosthetic valve located at the first end compressed radially inwardly and held in a delivery state within the interior portion of the retractable sheath and configured to expand in a radially outward direction to frictionally engage at least a portion of the native heart valve;

an aortic conduit comprising a balloon-expandable tubular frame and a tubular sleeve extending axially along and against the balloon-expandable frame, the aortic conduit being coupled to an end of the prosthetic valve and crimped around the balloon, the balloon extending along the conduit but not within the prosthetic valve.

2. The system of claim 1, wherein the balloon-expandable tubular frame comprises a plastically deformable metal material.

3. The system of claim 1, wherein prosthetic valve includes a self-expandable stent and flexible valve leaflets supported within the self-expandable stent.

4. The system of claim 3, wherein the balloon-expandable tubular frame and self-expandable stent are a single stent contiguously formed of a Nitinol alloy.

5. The system of claim 3, wherein the prosthetic valve further comprises an annular ring of a woven material coupling the valve leaflets to the self-expandable stent.

6. The system of claim 5, further including an outer tubular sleeve extending axially along and outside of the balloon-expandable tubular frame to provide a tubular surface between the aortic conduit and surrounding native tissue.

7. The system of claim 1, wherein the tubular sleeve is an inner tubular sleeve that extends axially along and within the balloon-expandable tubular frame to provide a tubular barrier between the balloon-expandable conduit and blood flowing through the aortic conduit.

8. The system of claim 1, wherein the tubular sleeve comprises a collagen gel absorbed into a woven polyester substrate.

9. The system of claim 1, wherein the tubular sleeve comprises bioprosthetic tissue selected from a group consisting of a bovine pericardium, a porcine pericardium, and an allogenic/autogenic collagen matrix tissue.

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

11. The system of claim 1, further comprising one or more anchors that are circumferentially spaced apart about an outer surface of the medical device and extend radially outwardly to facilitate attachment to surrounding tissue.

12. A system for use in replacing a native aortic heart valve of a human and repairing a defect in a section of the aorta contiguous with the native aortic heart valve, the system comprising:

a catheter having a balloon thereon;

a retractable sheath defining an interior portion;

a medical device sleeved over the catheter having a length sufficient to extend from a first end configured to be secured at the native aortic heart valve to a second end configured to be attached within and extending along the aorta at least as far as the aortic arch, the medical device comprising;

a prosthetic valve comprising a self-expandable stent and located at the first end, the prosthetic valve compressed radially inwardly and held in a delivery state by the retractable sheath and configured to expand in a radially outward direction to frictionally engage at least a portion of the native heart valve;

an aortic conduit comprising a balloon-expandable tubular frame and a tubular sleeve extending axially along and against the balloon-expandable frame, wherein the tubular frame and the self-expandable stent are a single stent contiguously formed of a Nitinol alloy, the aortic conduit being coupled to an end of the prosthetic valve and crimped around the balloon, the balloon extending along the conduit but not within the prosthetic valve.

13. The system of claim 12, wherein prosthetic valve includes flexible valve leaflets supported within the self-expandable stent.

14. The system of claim 13, wherein the prosthetic valve further comprises an annular ring of a woven material coupling the valve leaflets to the self-expandable stent.

15. The system of claim 12, wherein the tubular sleeve is an inner tubular sleeve that extends axially along and within the balloon-expandable tubular frame to provide a tubular barrier between the balloon-expandable conduit and blood flowing through the aortic conduit.

16. The system of claim 15, further including an outer tubular sleeve extending axially along and outside of the balloon-expandable tubular frame to provide a tubular surface between the aortic conduit and surrounding native tissue.

17. The system of claim 12, wherein the tubular sleeve comprises a collagen gel absorbed into a woven polyester substrate.

18. The system of claim 12, wherein the tubular sleeve comprises bioprosthetic tissue selected from a group consisting of a bovine pericardium, a porcine pericardium, and an allogenic/autogenic collagen matrix tissue.

19. The system of claim 18, wherein the bioprosthetic tissue is glycerolized to facilitate dry storage.

20. The system of claim 12, further comprising one or more anchors that are circumferentially spaced apart about an outer surface of the medical device and extend radially outwardly to facilitate attachment to surrounding tissue.