Prosthetic aortic heart valves

• US 9,421,097 B2
• Filed: 04/25/2014
• Issued: 08/23/2016
• Est. Priority Date: 08/24/2007
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Alkhatib, Yousef F.
• Primary Examiner(s): Iwamaye, Andrew
• Assistant Examiner(s): LOPEZ, LESLIE ANN
• Application Number:
  US14/261,628
• Publication Number:
  US 20140236289A1
• Time in Patent Office: 851 Days
• 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 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2445 Annuloplasty rings in direct contact with the valve annulus
• 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 2230/0017 Angular shapes
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid

Abstract

A prosthetic aortic valve includes an annular, annulus inflow portion that is designed to reside in or near the patient'"'"'s native aortic valve annulus, and an annular, aortic outflow portion that is designed to reside in the patient'"'"'s aorta downstream from at least a portion of the valsalva sinus. The annulus inflow portion and the aortic outflow portion are connected to one another by a plurality of connecting struts that are confined to regions near the commissures of the patient'"'"'s native aortic valve. The connecting struts are designed to bulge out into the valsalva sinus to help anchor the prosthetic valve in place. The valve is circumferentially collapsible to a relatively small diameter for less-invasive delivery into the patient. The valve circumferentially expands to a larger operational diameter when deployed at the implant site.

Claims

1. A prosthetic aortic valve, comprising:

an annular stent frame including (1) an annulus inflow portion configured for disposition, in use, adjacent a patient'"'"'s native aortic valve annulus, (2) an aortic outflow portion configured for disposition, in use, in the patient'"'"'s native aorta downstream from at least a portion of the patient'"'"'s native valsalva sinus, and (3) a plurality of connecting struts connecting the annulus inflow portion to the aortic outflow portion, each of the connecting struts, in use, having a shape that is bulged radially outwardly into the sinus of valsalva between the annulus inflow portion and the aortic outflow portion, the annulus inflow portion defining a plurality of commissure tips that are spaced from one another in an annular direction around the annulus inflow portion, each of the commissure tips having a free end, the free ends being features of the annulus inflow portion that are closest to the aortic outflow portion, each of the connecting struts being connected to the annulus inflow portion only at points that are farther from the aortic outflow portion than each of the commissure tips, each of the commissure tips having;

a pair of the connecting struts associated with the commissure tip including a first connecting strut disposed on one side of the commissure tip in the annular direction and a second connecting strut disposed on another side of the commissure tip in the annular direction, so that the first connecting strut and the second connecting strut are spaced apart from one another by a distance in the annular direction that is less than the distance in the annular direction between the first connecting strut and a next adjacent connecting strut not in the pair and the second connecting strut is not between the first connecting strut and the next adjacent connecting strut, each of the distances being measured at the free end of each of the commissure tips; and

a plurality of valve leaflets supported by the annulus inflow portion.

2. The prosthetic aortic valve defined in claim 1 wherein the stent frame is elastically and annularly compressible to a first relatively small size.

3. The prosthetic aortic valve defined in claim 2 wherein the stent frame is elastically and annularly re-expandable from the first size to a second relatively large size.

4. The prosthetic aortic defined in claim 3 wherein the first size is suitable for delivery of the valve into the patient.

5. The prosthetic aortic valve defined in claim 4 wherein the second size is suitable for use of the valve in and by the patient.

6. The prosthetic aortic valve defined in claim 1 wherein the annulus inflow portion is annularly continuous all the way around the valve.

7. The prosthetic aortic valve defined in claim 1 wherein the aortic outflow portion is annularly continuous all the way around the valve.

8. The prosthetic aortic valve defined in claim 1 wherein the annulus inflow portion has at least one interruption in the annular direction.

9. The prosthetic aortic valve defined in claim 1 wherein the aortic outflow portion has at least one interruption in the annular direction.

10. The prosthetic aortic valve defined in claim 1 further comprising a plurality of anchor members that are resiliently biased to incline outwardly from the stent frame.

11. The prosthetic aortic valve defined in claim 1 further comprising an annular cuff that is mounted on the annulus inflow portion.

12. The prosthetic aortic valve defined in claim 1 wherein each of the commissure tips is at a free end of a respective single structural member that is cantilevered from at least a respective single point on remaining structure of the annulus inflow portion.

13. The prosthetic aortic valve defined in claim 1 wherein each of the commissure tips is at a free apex of a V-shaped structure that is cantilevered from at least a respective pair of points on remaining structure of the annulus inflow portion.

14. The prosthetic aortic valve defined in claim 1 wherein the stent frame defines a plurality of apertures for use in securing at least one of the leaflets to the stent frame.

15. The prosthetic aortic valve defined in claim 1 wherein the stent frame defines a plurality of apertures for use with a delivery system for the valve.

16. The prosthetic aortic valve defined in claim 1 wherein the annulus inflow portion includes a pair of structural members that are integral with one another at a curved corner that is initially C-shaped and that becomes more U-shaped when the structural members move away from one another in a direction that is annular of the valve.

17. The prosthetic aortic valve defined in claim 1 wherein the aortic outflow portion includes one structure that undulates toward and away from the annulus inflow portion as one proceeds in the annular direction around the valve and the annulus inflow portion includes another structure that undulates toward and away from the aortic outflow portion as one proceeds in the annular direction around the valve.

18. The prosthetic aortic valve defined in claim 17 wherein the structure of the aortic outflow portion that undulates has approximately a same number of undulations as the structure of the annulus inflow portion that undulates.

19. The prosthetic aortic valve defined in claim 17 wherein the structure of the aortic outflow portion that undulates has more undulations than the structure of the annulus inflow portion that undulates.

20. The prosthetic aortic valve defined in claim 1 wherein an edge of the annulus inflow portion that is most remote from the aortic outflow portion includes a recessed edge portion aligned with at least one of the commissure tips, the recessed edge portion being closer to the aortic outflow portion than other portions of the edge of the annulus inflow portion.

21. The prosthetic aortic valve defined in claim 1 further comprising fabric inside at least a portion of the stent frame.

22. The prosthetic aortic valve defined in claim 1 further comprising fabric outside at least a portion of the stent frame.

23. The prosthetic aortic valve defined in claim 1 further comprising tissue material as a buffer between the stent frame and at least one of the leaflets to prevent abrasion and provide longer durability performance.

24. The prosthetic aortic valve defined in claim 23 wherein the tissue material is thinner than each of the leaflets.

25. The prosthetic aortic valve defined in claim 1 wherein each of the leaflets is made of a material selected from the group consisting of biological tissue, polymer, thin metal, and reinforced polymer.