AORTIC INSUFFICIENCY REPAIR DEVICE AND METHOD

• US 20160081829A1
• Filed: 09/22/2015
• Published: 03/24/2016
• Est. Priority Date: 09/22/2014
• Status: Abandoned Application

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Rowe, Stanton J.
• Application Number:
  US14/861,140
• Publication Number:
  US 20160081829A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 2002/061 provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2250/006 modular

Abstract

The present application concerns embodiments of methods, systems, and apparatus for treating aortic insufficiency. Disclosed methods, systems and apparatus can also be used to treat aortic root dilation. Certain embodiments include a percutaneous or minimally invasively implantable prosthetic device, such as a stented graft, that is configured to be implanted in the sinus of Valsalva (the aortic sinuses) and anchored within one or both of the coronary arteries. An expandable prosthetic heart valve can then be implanted in the previously implanted prosthetic device. In patients suffering from root dilation, another percutaneous or minimally invasively implantable graft can be implanted within the ascending aorta.

Claims

1. A method comprising:

introducing a guidewire into a patient'"'"'s body;

advancing the guidewire until a distal end portion of the guidewire extends into the aortic root and into one of the coronary arteries;

advancing a prosthetic device along the guidewire into the aortic root;

aligning a side opening of the prosthetic device with the coronary artery into which the guidewire extends; and

radially expanding the prosthetic device within the aortic root.

2. The method of claim 1, further comprising implanting a prosthetic valve within the prosthetic device.

3. The method of claim 2, wherein implanting the prosthetic valve within the prosthetic device comprises introducing the prosthetic valve into the patient'"'"'s body on a catheter and radially expanding the prosthetic valve within the prosthetic device.

4. The method of claim 1, wherein the prosthetic device comprises prosthetic valve leaflets.

5. The method of claim 1, further comprising implanting a stented graft in the ascending aorta.

6. The method of claim 5, wherein an inflow end portion of the stented graft overlaps an outflow end portion of the prosthetic device.

7. The method of claim 1, wherein:

the act of introducing a guidewire into a patient'"'"'s body comprises introducing first and second guidewires into the patient'"'"'s body;

the act of advancing the guidewire comprises advancing the first and second guidewires until distal end portions of the guidewires extend into the aortic root and each distal end portion extends into one of the coronary arteries;

the act of advancing a prosthetic device comprises advancing the prosthetic device along the first and second guidewires into the aortic root; and

the act of aligning a side opening of the prosthetic device comprises aligning first and second side openings of the prosthetic device with the coronary arteries.

8. The method of claim 7, wherein prior to the act of advancing the prosthetic device along the first and second guidewires, placing the prosthetic device on a delivery apparatus and inserting the proximal ends of the first and second guidewires through the first and second side openings of the prosthetic device.

9. The method of claim 1, further comprising implanting a branch conduit in the coronary artery into which the guidewire extends, one end of the branch conduit being in communication with the side opening of the prosthetic device to allow blood to flow outwardly through the branch conduit into the coronary artery.

10. The method of claim 9, wherein the prosthetic device comprises an annular main body and the branch conduit, which is connected to the main body, wherein the main body and the branch conduit are delivered to the aortic root at the same time.

11. The method of claim 9, wherein the prosthetic device comprises an annular main body that is radially expanded in the aortic root and the branch conduit is separate from the main body and is inserted into the patient and implanted after the main body is implanted.

12. The method of claim 1, wherein an inflow end of the prosthetic device is implanted above the native aortic valve leaflets.

13. The method of claim 1, wherein radially expanding the prosthetic device causes the prosthetic device to engage the inner wall of the aortic root.

14. An implantable prosthetic device configured for implantation in the aortic root of a patient, the prosthetic device comprising:

an annular body configured to be radially compressed to a delivery state for insertion into the patient and expandable to an expanded state against the inner wall of the aortic root; and

first and second openings in the annular body and configured to allow blood to flow outwardly through the openings and into the coronary arteries when the annular body is in an expanded state engaging the inner wall of the aortic root.

15. The prosthetic device of claim 14, further comprising at least one branch conduit extending from one of the first and second openings and configured to be implanted within one of the coronary arteries.

16. The prosthetic device of claim 15, wherein the at least one branch conduit comprises first and second branch conduits extending from the first and second side openings, respectively, and configured to be implanted within the coronary arteries.

17. The prosthetic device of claim 15, wherein the at least one branch conduit is separate from the annular body.

18. The prosthetic device of claim 14, wherein the annular body comprises a radially compressible and expandable metal frame and a blood-impermeable liner supported by the frame.

19. The prosthetic device of claim 14, further comprising prosthetic valve leaflets supported within the annular body.

20. The prosthetic device of claim 15, wherein the branch conduit is radially compressible for delivery into the patient and radially expandable to an expanded state to engage an inner wall of the coronary artery.

21. A medical device assembly comprising:

first and second guidewires;

an elongated delivery apparatus having a distal end portion; and

an implantable prosthetic device configured to be implanted within the aortic root of a patient'"'"'s body, the prosthetic device being mounted in a radially compressed state on the distal end portion of the delivery apparatus, the prosthetic device comprising an annular body and first and second openings in the annular body and configured to allow blood to flow outwardly through the openings and into the coronary arteries when the annular body is in an expanded state engaging the inner wall of the aortic root;

wherein the first and second guidewires extend into and through the first and second openings, respectively, and through the annular body.