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

• US 9,585,748 B2
• Filed: 09/20/2013
• Issued: 03/07/2017
• 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): Shi, Katherine M
• Assistant Examiner(s): Gabr, Mohamed
• Application Number:
  US14/033,075
• Publication Number:
  US 20140088692A1
• Time in Patent Office: 1,264 Days
• Field of Search: 623/2.1, 623/2.11, 623/2.14, 623 217- 218, 623/2.2, 623/2.21
• US Class Current: 1/1
• 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 method, comprising:

delivering with a sheath a balloon-expandable conduit into an ascending aorta extending from a native aortic heart valve, the balloon-expandable conduit being coupled in series to a self-expandable prosthetic heart valve having flexible leaflets to form a valved conduit, wherein the balloon-expandable conduit and the self-expandable prosthetic heart valve are both supported by a common stent contiguously formed of Nitinol, and simultaneously positioning the self-expandable prosthetic heart valve within the native aortic heart valve;

retracting the sheath from around the balloon-expandable conduit and self-expandable prosthetic heart valve so that the prosthetic heart valve expands into a functional form with the native aortic heart valve; and

inflating a balloon disposed within the balloon-expandable conduit such that the balloon-expandable conduit expands into a functional form and an outer surface thereof contacts the ascending aorta.

2. The method of claim 1, further comprising engaging at least one of the ascending aorta or native aortic heart valve with one or more anchors coupled to at least one of the conduit or prosthetic heart valve.

3. The method of claim 1, wherein the balloon-expandable conduit includes an inner tubular sleeve extending axially along and within the balloon-expandable conduit to provide a tubular barrier between the balloon-expandable conduit and blood flowing through the valved conduit.

4. The method of claim 3, wherein the valved conduit includes an outer tubular sleeve extending axially along and outside of the balloon-expandable conduit and prosthetic heart valve to provide a tubular surface between the valved conduit and surrounding native tissues.

5. The method of claim 4, wherein the inner and outer tubular sleeves comprise a collagen gel absorbed into a woven polyester substrate.

6. The method of claim 1, wherein the flexible heart valve leaflets are attached to an annular ring of a woven material that couples the valve leaflets to the tubular stent.

7. The method of claim 1, wherein a first portion of the Nitinol stent extending along the balloon-expandable conduit is plastically deformable, while a second portion of the stent extending around the prosthetic heart valve has been heat treated to have an expanded memory shape and is held along with the prosthetic heart valve in a radially compressed configuration within the sheath.

8. The method of claim 1, wherein the flexible heart valve leaflets are bioprosthetic valve leaflets glycerolized to enable dry storage of the valved conduit.

9. The method of claim 1, wherein the sheath comprises at least one radiopaque marker on an outer surface thereof, and the method includes visualizing the radiopaque marker during the step of delivering.

10. The method of claim 1, further comprising anchoring one or more anchors that extend outwardly from at least one of the balloon-expandable conduit or the prosthetic heart valve into surrounding native tissue.

11. The method of claim 10, wherein the one or more anchors comprise a tissue irritation structure to induce tissue ingrowth.

12. The method of claim 1, wherein:

a first portion of the stent extending along the balloon-expandable conduit self-maintains a compressed condition around a balloon of a balloon catheter while a second portion of the stent extending around the prosthetic heart valve has been heat treated to have an expanded memory shape and is held along with the prosthetic heart valve in a radially compressed configuration within the sheath;

delivering the valved conduit on a balloon catheter to the native aortic heart valve such that the balloon-expandable conduit resides within an ascending aorta extending from the native aortic heart valve when the prosthetic heart valve is within the native aortic heart valve.

13. The method of claim 12, wherein the valved conduit includes an inner tubular sleeve extending axially along and within the first portion of the stent to provide a tubular barrier between the first portion of the stent and blood flowing through the valved conduit.

14. The method of claim 13, wherein the valved conduit includes an outer tubular sleeve extending axially along and outside of the stent to provide a tubular surface between the stent and surrounding native tissues.

15. The method of claim 14, wherein the inner and outer tubular sleeves comprise a collagen gel absorbed into a woven polyester substrate.

16. The method of claim 12, wherein the flexible heart valve leaflets are attached to an annular ring of a woven material that couples the valve leaflets to the second portion of the stent.

17. The method of claim 12, wherein the flexible heart valve leaflets are bioprosthetic valve leaflets glycerolized to enable dry storage of the valved conduit.

18. The method of claim 12, wherein the sheath comprises at least one radiopaque marker on an outer surface thereof, and the method includes visualizing the radiopaque marker during the step of delivering the valved conduit on the balloon catheter to a site of implantation.

19. The method of claim 12, wherein one end of the stent frame is plastically expandable for supporting the balloon-expandable conduit and the other end of the stent frame has an expanded memory shape for supporting the self-expandable prosthetic valve.

20. The method of claim 12, further comprising anchoring one or more anchors that extend outwardly from at least one of the balloon-expandable conduit or the prosthetic heart valve into surrounding native tissue.

21. The method of claim 20, wherein the one or more anchors comprise a tissue irritation structure to induce tissue ingrowth.

22. A method comprising:

coupling a self-expandable prosthetic heart valve having valve leaflets adjacent a balloon-expandable conduit having a bioprosthetic sleeve to form a valved conduit, wherein the balloon-expandable conduit and prosthetic heart valve are both circumferentially supported by a common stent frame contiguously formed of Nitinol, wherein one end of the stent frame is plastically expandable for supporting the balloon-expandable conduit and the other end of the stent frame has an expanded memory shape for supporting the self-expandable prosthetic heart valve;

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

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

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