Cuff configurations for prosthetic heart valve

• US 10,136,992 B2
• Filed: 06/22/2015
• Issued: 11/27/2018
• Est. Priority Date: 03/14/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories Incorporated)
• Inventors: Schraut, Julia A., Braido, Peter N., Venkatasubramanian, Ramji T., Kurane, Aditee, Fahim, Mina S., Kutty, Jaishankar
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): Nelson, Christine
• Application Number:
  US14/745,840
• Publication Number:
  US 20150282932A1
• Time in Patent Office: 1,254 Days
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• 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 2/2445 Annuloplasty rings in direct contact with the valve annulus
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0028 differing in fibre orientations
• CPC Class Codes: A61F 2250/0036 differing in thickness
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts. The heart valve further includes a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the cuff being coupled to selected ones of the plurality of struts and having microspheres disposed therein. The microspheres are capable of expanding upon contact with blood.

Claims

1. A prosthetic heart valve comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts;

a collapsible and expandable valve assembly including a cuff and a plurality of leaflets, the cuff being folded over itself to form an inner layer and an outer layer, the cuff being coupled to selected ones of the plurality of struts and having microspheres disposed therein, the microspheres being capable of expanding upon contact with blood.

2. The prosthetic heart valve of claim 1, wherein the cuff is formed of a porous material.

3. The prosthetic heart valve of claim 2, wherein the microspheres are embedded in the porous material.

4. The prosthetic heart valve of claim 1, wherein the microspheres comprise dry polyvinyl alcohol sodium acrylate.

5. The prosthetic heart valve of claim 1, further comprising a protection layer disposed on the cuff and configured to prevent expansion of the microspheres prior to implantation of the heart valve.

6. The prosthetic heart valve of claim 1, wherein the microspheres are incorporated into a material of the cuff.

7. The prosthetic heart valve of claim 1, wherein the cuff includes a porous membrane having a plurality of pores.

8. The prosthetic heart valve of claim 7, wherein the plurality of pores have a first size that is larger enough to allow blood to pass therethrough.

9. The prosthetic heart valve of claim 1, wherein the microspheres are capable of swelling when contacted by blood.

10. The prosthetic heart valve of claim 1, wherein expansion of the microspheres induces a diametric expansion of the cuff.

11. The prosthetic heart valve of claim 1, wherein the cuff is configured to expand from a first diameter to a second diameter upon expansion of the microspheres, the second diameter being sufficient to occlude gaps between the stent and a native valve annulus.

12. The prosthetic heart valve of claim 1, wherein the cuff is formed of a foam.

13. The prosthetic heart valve of claim 1, wherein the cuff includes a shape-memory portion.

14. The prosthetic heart valve of claim 1, wherein the cuff includes a sponge-like portion.

15. The prosthetic heart valve of claim 1, further comprising at least two sutures, a first of the at least two sutures piercing through each of the inner layer and the outer layer, and a second of the at least two sutures piercing through only one of the inner layer and the outer layer.

16. The prosthetic heart valve of claim 1, further comprising a first and a second suture piercing through each of the inner layer and the outer layer, and a third suture piercing through the inner layer.

17. A prosthetic heart valve comprising:

a collapsible and expandable stent having a proximal end, a distal end, an annulus section adjacent the proximal end and an aortic section adjacent the distal end, the stent including a plurality of struts; and

a collapsible and expandable valve assembly including a plurality of leaflets and a cuff formed of a first material, the cuff being coupled to selected ones of the plurality of struts and having swellable elements formed of a second material disposed therein, the swellable elements being capable of expanding upon contact with blood,

wherein the swellable elements include a plurality of microspheres.

18. The prosthetic heart valve of claim 17, wherein the cuff is formed of a porous material.

19. The prosthetic heart valve of claim 17, wherein each of the plurality of microspheres includes dry polyvinyl alcohol sodium acrylate.