Prosthetic heart valve with expandable microspheres

• US 9,155,616 B2
• Filed: 12/20/2013
• Issued: 10/13/2015
• Est. Priority Date: 02/28/2013
• Status: Active Grant

• Current Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Original Assignee: St. Jude Medical Cardiology Division Incorporated (Abbott Laboratories)
• Inventors: Venkatasubramanian, Ramji T., Cho, Eunhee
• Primary Examiner(s): Sweet, Thomas J
• Assistant Examiner(s): Schutte, Wade P
• Application Number:
  US14/136,091
• Publication Number:
  US 20140243969A1
• Time in Patent Office: 662 Days
• Field of Search: 623/2.37
• US Class Current: 1/1
• 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 2210/0061 swellable
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes a valve assembly mounted to an expandable stent. The prosthetic heart valve includes a cuff coupled to the stent. The cuff includes a pocket formed between an outer side and an inner side of the cuff. The pocket includes a plurality of biocompatible and irreversibly expandable microspheres. After implantation of the prosthetic heart valve into a patient, any gaps existing between the cuff and the native heart valve are exposed to bodily fluid, such as blood. The blood enters the pocket of the cuff through pores in the outer side of the cuff. The blood interacts with the microspheres, causing irreversible expansion of the microspheres. The microspheres expand to fill any gaps between the prosthetic heart valve and the native heart tissue, sealing the gaps and preventing leakage through the gaps.

Claims

1. A prosthetic heart valve for replacement of a native valve comprising:

a stent having an outer side and an inner side;

a valve assembly mounted to the stent;

a cuff coupled to the stent and at least partially positioned on the outer side of the stent, the cuff including a plurality of pockets sealed from one another; and

a plurality of expandable microspheres confined within the plurality of pockets.

2. The prosthetic heart valve of claim 1, wherein the plurality of pockets are formed between an inner side of the cuff and an outer side of the cuff.

3. The prosthetic heart valve of claim 2, wherein the outer side of the cuff is positioned external to the outer side of the stent and the inner side of the cuff is positioned external to the outer side of the stent.

4. The prosthetic heart valve of claim 2, wherein the outer side of the cuff is positioned external to the outer side of the stent and the inner side of the cuff is positioned internal to the inner side of the stent.

5. The prosthetic heart valve of claim 2, wherein the outer side of the cuff defines a plurality of pores.

6. The prosthetic heart valve of claim 5, wherein each microsphere has a diameter and each pore has a maximum width, the maximum width of each pore being less than the diameter of each microsphere.

7. The prosthetic heart valve of claim 5, wherein the outer side of the cuff includes salt crystals.

8. The prosthetic heart valve of claim 2, further comprising a protective layer coupled to the outer side of the cuff configured to prevent fluid crossing from the outer side of the cuff into the plurality of pockets.

9. The prosthetic heart valve of claim 8, wherein the protective layer is formed from a hydrophobic material.

10. The prosthetic heart valve of claim 8, wherein the protective layer includes an adhesive on an inner side thereof configured to adhere to the outer side of the cuff.

11. The prosthetic heart valve of claim 1, further comprising at least one suture coupling the cuff to the stent, the at least one suture forming the plurality of pockets.

12. The prosthetic heart valve of claim 11, further comprising:

a first group of microspheres within one of the plurality of pockets; and

a second group of microspheres within a second of the plurality of pockets, wherein the at least one suture separates the first group of microspheres from the second group of microspheres.

13. The prosthetic heart valve of claim 1, wherein the plurality of expandable microspheres are at least partially formed of polyvinyl alcohol.

14. A prosthetic heart valve for replacement of a native valve comprising:

a stent having an outer side and an inner side;

a valve assembly mounted to the stent;

a cuff coupled to the stent and at least partially positioned on the outer side of the stent, the cuff being coupled to the stent by at least one suture, the at least one suture forming a plurality of pockets sealed from one another; and

a biocompatible expandable material confined within at least one of the plurality of pockets.

15. The prosthetic heart valve of claim 14, wherein the biocompatible expandable material is formed as a sheet.

16. The prosthetic heart valve of claim 15, wherein the sheet of biocompatible expandable material is cylindrical.

17. The prosthetic heart valve of claim 15, wherein at least one of the plurality of pockets contains a portion of the sheet of biocompatible expandable material.