PROSTHETIC LEAFLET ASSEMBLY FOR REPAIRING A DEFECTIVE CARDIAC VALVE AND METHODS OF USING THE SAME

• US 20120323313A1
• Filed: 06/19/2012
• Published: 12/20/2012
• Est. Priority Date: 06/20/2011
• Status: Active Grant

• Current Assignee: Jacques Seguin
• Original Assignee: Jacques Seguin
• Inventors: Seguin, Jacques
• Granted Patent: US 9,011,523 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 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/2454 Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition

Abstract

Methods and apparatus are provided for repairing or replacing a defective cardiac valve including a prosthetic leaflet assembly having an expandable frame with one or more anchors configured to engage a predetermined region of the defective cardiac valve in an expanded deployed state, and at least one prosthetic leaflet coupled to the expandable frame. The prosthetic leaflet assembly is configured such that the prosthetic leaflet is suspended within a flow path of the defective cardiac valve and coapts with, and improves functioning of, one or more native leaflets of the defective cardiac valve.

Claims

1. A prosthetic leaflet assembly for repairing a defective cardiac valve having one or more native leaflets defining a flow path, the prosthetic leaflet assembly comprising:

an expandable frame configured to transition from a contracted delivery state to an expanded deployed state, the expandable frame having one or more anchors configured to engage a predetermined region of the defective cardiac valve in the expanded deployed state; and

one or more prosthetic leaflets coupled to the expandable frame, the one or more prosthetic leaflets configured to be suspended within the flow path and to coapt with, and improve functioning of, the one or more native leaflets.

2. The prosthetic leaflet assembly of claim 1, wherein the expandable frame further comprises one or more stabilization members configured to be disposed upstream of the defective cardiac valve to prevent the one or more native leaflets from prolapsing and to prevent migration of the prosthetic leaflet assembly.

3. The prosthetic leaflet assembly of claim 1, wherein the expandable frame further comprises one or more biasing members configured to urge the one or more anchors into engagement with the predetermined regions.

4. The prosthetic leaflet assembly of claim 1, wherein the one or more anchors comprise first and second anchors, and wherein the one or more prosthetic leaflets are disposed between the first and second anchors.

5. The prosthetic leaflet assembly of claim 1, wherein the predetermined region comprises commissural areas of the defective cardiac valve.

6. The prosthetic leaflet assembly of claim 1, wherein the expandable frame and the one or more prosthetic leaflets are configured to transition between a delivery state enabling transcatheter delivery and an expanded, deployed state.

7. The prosthetic leaflet assembly of claim 1, wherein the prosthetic leaflet assembly is configured to repair one of a mitral valve, a tricuspid valve, an aortic valve, or a pulmonary valve.

8. The prosthetic leaflet assembly of claim 1, wherein the expandable frame is self-expanding.

9. The prosthetic leaflet assembly of claim 8, wherein the expandable frame comprises a nickel-titanium alloy.

10. The prosthetic leaflet assembly of claim 1, wherein the one or more prosthetic leaflets comprise animal tissue.

11. The prosthetic leaflet assembly of claim 10, wherein the animal tissue comprises porcine, equine, or bovine pericardial tissue.

12. The prosthetic leaflet assembly of claim 1, wherein the one or more prosthetic leaflets comprise a synthetic fabric.

13. The prosthetic leaflet assembly of claim 1, wherein the prosthetic leaflet assembly is configured to be delivered transvascularly or transapically using a minimally invasive approach.

14. The prosthetic leaflet assembly of claim 1, wherein the expandable frame is configured to accommodate deployment of a replacement valve, such that the expandable frame serves as an anchor for the replacement valve.

15. The prosthetic leaflet assembly of claim 14, wherein the replacement valve prosthesis is configured to be implanted seconds, days, months, or years after the prosthetic leaflet assembly is deployed.

16. A method of repairing a defective cardiac valve having one or more native leaflets defining a flow path, the method comprising:

providing a prosthetic leaflet assembly having one or more prosthetic leaflets mounted on an expandable frame, the expandable frame having one or more anchors;

implanting the prosthetic leaflet assembly in a heart having the defective cardiac valve by engaging the one or more anchors to a predetermined region of the defective cardiac valve, such that the one or more prosthetic leaflets are suspended within the flow path and coapt with, and improve functioning of, the one or more native leaflets.

17. The method of claim 16, wherein engaging the predetermined region further comprises transitioning the prosthetic leaflet assembly between a delivery state and an expanded, deployed state.

18. The method of claim 16, wherein the expandable frame is self-expanding, and wherein engaging the predetermined region further comprises releasing the self-expanding expandable frame.

19. The method of claim 16, further comprising preventing the one or more native leaflets from prolapsing during systole using one or more stabilization members of the expandable frame disposed upstream of the defective cardiac valve.

20. A catheter for delivering a prosthetic leaflet assembly at a defective cardiac valve, the catheter comprising:

a tube having a distal end, a proximal end, and an internal lumen extending between the distal and proximal ends;

a stylet disposed within the internal lumen, the stylet having an end cap disposed at a distal end of the stylet; and

a suture disposed within the internal lumen, the suture engaging the prosthetic leaflet assembly when the prosthetic leaflet assembly is disposed within the internal lumen in a contracted delivery state,

wherein the end cap contacts the distal end of the tube in the contracted delivery state.