Aortic valve and conduit graft implant tool

• US 9,844,436 B2
• Filed: 10/24/2013
• Issued: 12/19/2017
• Est. Priority Date: 10/26/2012
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: De Paulis, Ruggero, Murad, Michael C.
• Primary Examiner(s): Tyson, Melanie
• Application Number:
  US14/062,424
• Publication Number:
  US 20140121764A1
• Time in Patent Office: 1,517 Days
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers

Abstract

A sizing tool for use in implanting a composite valved conduit having a prosthetic heart valve on a distal end attached to a conduit graft that extends to a proximal end. The tool includes a proximal handle and a distal shaft, a prosthetic heart valve sizer having an axis affixed to a distal end of the shaft, and a conduit graft replica having an axis mounted on the shaft proximal to the heart valve sizer. A method of securing a composite valved conduit includes introducing to an excised ascending aorta the sizing tool, measuring the aortic annulus with the prosthetic heart valve sizer, and determining whether the coronary arteries have sufficient length or whether an additional tubular coronary extension segment is required to add to one or both of the ends of the coronary arteries by extending the coronary arteries toward the conduit graft replica.

Claims

1. A sizing tool for use in implanting a composite aortic valved conduit having a prosthetic aortic heart valve on a distal end attached to an aortic conduit graft that extends to a proximal end, the aortic conduit graft having an outwardly-bulged distal region adjacent an inflow end and a proximal tubular portion extending to an outflow end coincident with the proximal end of the composite aortic valved conduit, the tool comprising:

a proximal handle and a shaft extending distally therefrom;

a prosthetic heart valve sizer having an axis affixed to a distal end of the shaft; and

an aortic conduit graft replica shaped like the outwardly-bulged distal region of the aortic conduit graft and having an axis mounted on the shaft proximal to the heart valve sizer, wherein the aortic conduit graft replica is mounted to slide on the shaft between the heart valve sizer and the proximal handle.

2. The tool of claim 1, further including a locking mechanism for fixing the position of the aortic conduit graft replica on the shaft.

3. The tool of claim 1, wherein the aortic conduit graft replica has an outwardly-bulged portion that simulates the outwardly-bulged distal region of the aortic conduit graft.

4. The tool of claim 3, wherein the outwardly bulged portion of the aortic conduit graft replica is axi-symmetric.

5. The tool of claim 3, wherein the tool includes markers thereon to indicate where on the outwardly-bulged portion the coronary arteries would connect to the outwardly-bulged distal region of the aortic conduit graft.

6. The tool of claim 1, further including a locking mechanism for selectively fixing the position of the aortic conduit graft replica against the proximal handle or against the heart valve sizer.

7. A sizing tool for use in implanting a composite aortic valved conduit having a prosthetic heart valve on a distal end attached to an aortic conduit graft that extends to a proximal end, the aortic conduit graft having an outwardly-bulged distal region adjacent an inflow end and a proximal tubular portion extending to an outflow end coincident with the proximal end of the composite aortic valved conduit, the tool comprising:

a proximal handle and a shaft extending distally therefrom;

a prosthetic heart valve sizer affixed to a distal end of the shaft, the sizer having a cylindrical distal portion centered on an axis; and

a replica of the outwardly-bulged distal region of the aortic conduit graft having an axis mounted to slide on the shaft and proximal to the heart valve sizer and adapted to be displaced axially along the shaft from a distal position abutting the heart valve sizer to a proximal position adjacent the handle.

8. The tool of claim 7, further including a locking mechanism for fixing the position of the aortic conduit graft replica against the proximal handle.

9. The tool of claim 8, wherein the locking mechanism comprises an inner hub on a proximal end of the aortic conduit graft replica having a bore and an inwardly-directed rib that closely fits over a distal end of the handle having an inward circular groove that engages the rib.

10. The tool of claim 7, wherein the aortic conduit graft replica has an outwardly-bulged portion that simulates the outwardly-bulged distal region of the aortic conduit graft.

11. The tool of claim 10, wherein the tool includes markers thereon to indicate where on the outwardly-bulged portion the coronary arteries would connect to the outwardly-bulged distal region of the aortic conduit graft.

12. The tool of claim 7, wherein the heart valve sizer has a proximal face that has an undulating shape around the sizer axis and the aortic conduit graft replica has a distal face that has an undulating shape around the replica axis that mates with the proximal face of the sizer.

13. A sizing tool for use in implanting a composite aortic valved conduit having a prosthetic heart valve on a distal end attached to an aortic conduit graft that extends to a proximal end, the aortic conduit graft an elongated tubular proximal section and an outwardly-bulged distal region that mimics native aortic sinuses, the tool comprising:

a proximal handle and a distal shaft extending distally therefrom;

a prosthetic heart valve sizer having an axis affixed to a distal end of the shaft; and

an aortic conduit graft replica having an axis mounted on the shaft proximal to the heart valve sizer and having an outwardly-bulged portion that simulates the outwardly-bulged distal region of the aortic conduit graft, wherein the outwardly-bulged portion of the aortic conduit graft replica includes markers thereon to indicate where on the outwardly-bulged portion the coronary arteries would connect to the outwardly-bulged distal region of the aortic conduit graft.

14. The tool of claim 13, wherein the outwardly-bulged portion of the aortic conduit graft replica is axi-symmetric.

15. The tool of claim 13, wherein the aortic conduit graft replica is mounted to slide on the shaft between the heart valve sizer and the proximal handle.

16. The tool of claim 15, wherein the heart valve sizer has a proximal face that has an undulating shape around the sizer axis and the aortic conduit graft replica has a distal face that has an undulating shape around the replica axis that mates with the proximal face of the sizer.

17. The tool of claim 15, further including a locking mechanism for fixing the position of the aortic conduit graft replica on the shaft against the proximal handle.

18. The tool of claim 15, further including a locking mechanism for fixing the position of the aortic conduit graft replica on the shaft against the heart valve sizer.

19. A sizing tool for use in implanting a composite aortic valved conduit having a prosthetic aortic heart valve on a distal end attached to an aortic conduit graft that extends to a proximal end, the aortic conduit graft having an outwardly-bulged distal region adjacent an inflow end and a proximal tubular portion extending to an outflow end coincident with the proximal end of the composite aortic valved conduit, the tool comprising:

a proximal handle and a shaft extending distally therefrom;

a prosthetic heart valve sizer having an axis affixed to a distal end of the shaft; and

an aortic conduit graft replica shaped like the outwardly-bulged distal region of the aortic conduit graft and having an axis mounted on the shaft proximal to the heart valve sizer, wherein the heart valve sizer has a proximal face that has an undulating shape around the sizer axis and the aortic conduit graft replica has a distal face that has an undulating shape around the replica axis that mates with the proximal face of the sizer.

20. The tool of claim 19, wherein the aortic conduit graft replica has an outwardly-bulged portion that simulates the outwardly-bulged distal region of the aortic conduit graft.

21. The tool of claim 20, wherein the tool includes markers thereon to indicate where on the outwardly-bulged portion the coronary arteries would connect to the outwardly-bulged distal region of the aortic conduit graft.

22. The tool of claim 19, wherein the aortic conduit graft replica is mounted to slide on the shaft between the heart valve sizer and the proximal handle.

23. The tool of claim 22, further including a locking mechanism for fixing the position of the aortic conduit graft replica on the shaft against the proximal handle.

24. The tool of claim 23, further including a locking mechanism for fixing the position of the aortic conduit graft replica on the shaft against the heart valve sizer.