EXPANDABLE VALVE PROSTHESIS WITH SEALING MECHANISM

• US 20090099653A1
• Filed: 10/12/2007
• Published: 04/16/2009
• Est. Priority Date: 10/12/2007
• Status: Active Grant

• Current Assignee: Corcym SRL (LivaNova Plc), Mayo Foundation For Medical Education And Research (Mayo Clinic)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Suri, Rakesh M., Manasse, Eric, Ziarno, W. Andrew
• Granted Patent: US 9,848,981 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0069 Sealing means

Abstract

A prosthetic heart valve includes at least one sealing member. The sealing member is adapted to conform to any surface irregularities found on the inner surface of the valve annulus, including any calcium deposits formed on the valve leaflets. The sealing member can be self-expanding or non-expanding. When deployed, the sealing member is adapted to create a blood tight seal between the prosthetic heart valve and the inner surface of the valve annulus thereby minimizing and/or eliminating perivalvular leakage at the implantation site.

Claims

1. An expandable heart valve prosthesis comprising:

at least one sealing member, the sealing member sized and dimensioned to provide a seal between stenotic native valve leaflets and the prosthesis prevents paravalvular leakage.

2. The prosthesis of claim 1, wherein the sealing member is selected from the group consisting of a viscoelastic material and pericardium.

3. The prosthesis of claim 1, wherein the sealing member comprises silicone rubber or latex rubber.

4. The prosthesis of claim 1, wherein the expandable valve prosthesis is selected from the group consisting of a self-expanding heart valve prosthesis and a balloon expandable heart valve prosthesis.

5. The prosthesis of claim 1, wherein the sealing member does not need to expand in volume to provide the seal.

6. The prosthesis of claim 1, wherein the sealing member decreases in volume upon expansion of the prosthesis, from an undeployed state to a deployed state.

7. The prosthesis of claim 1, wherein the sealing member comprises a gel.

8. The prosthesis of claim 1, wherein the seal formed between the prosthesis and the inner surface of the valve annulus is an annular seal.

9. A method of replacing a diseased native heart valve, the method comprising:

placing at least a portion of an expandable heart valve prosthesis over a calcification on a native valve leaflet, and conforming the portion to the contours of the calcification using a sealing member that does not increase in volume during deployment.

10. The method of claim 9 further comprising excising at least a portion of the native heart valve leaflet to obtain an excised portion.

11. The method of claim 9 further comprising capturing the excised portion for external removal thereof.

12. The method of claim 9, wherein the portion located within the annulus comprises extracellular matrix material, the material adapted to promote natural tissue ingrowth in the portion.

13. A kit for replacement of a diseased heart valve, the kit comprising:

an expandable heart valve prosthesis, a seal sized and dimensioned to restrict the flow of blood between the prosthesis and an inner surface of the valve annulus, and a delivery system for deployment of the prosthesis.

14. The kit of claim 13, wherein the inner surface of the valve annulus includes one or more calcified valve leaflets.

15. The kit of claim 13, wherein the seal is sized and dimensioned to conform to one or more surface irregularities on the inner surface of the valve annulus.

16. The kit of claim 13 further comprising a leaflet excision tool.

17. A method of replacing a diseased native heart valve comprising:

creating an aperture by excising one or more heart valve leaflets or portions thereof, deploying an expandable heart valve prosthesis, at least a portion of the prosthesis being located in the aperture, and forming a seal between the prosthesis and the aperture to prevent blood flow past the prosthesis in a manner in which the seal does not expand in volume.

18. The method of claim 17, wherein the seal is formed between the prosthesis and the annulus by positioning a sealing member at a location selected from the group consisting of:

the valve annulus, a location above the valve annulus, a location below the valve annulus, and combinations thereof.

19. An expandable heart valve prosthesis comprising a free floating seal above the annulus.

20. The prosthesis of claim 19 further comprising an inflow portion, the inflow portion formed of a material capable of exerting a sufficient radial force to maintain a steady state, expanded orifice in relation to ballooned, calcified, native valve leaflets.