Sizing methods for a valved conduit graft

• US 10,537,430 B2
• Filed: 12/18/2017
• Issued: 01/21/2020
• 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 R
• Application Number:
  US15/844,878
• Publication Number:
  US 20180104058A1
• Time in Patent Office: 764 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 method of sizing a patient'"'"'s aortic valve annulus and two coronary arteries for implant of a composite valved conduit having a prosthetic heart valve on a distal end attached to a conduit graft that extends to a proximal end, comprising:

obtaining a sizing tool having a proximal handle and a shaft extending distally therefrom, a heart valve sizer defining an axis and affixed to a distal end of the shaft, and a conduit graft replica defining an axis and mounted on the shaft proximal to the heart valve sizer;

accessing the patient'"'"'s heart;

severing the two coronary arteries from the patient'"'"'s ascending aorta;

resecting a section of the ascending aorta from a location adjacent to the aortic valve annulus to leave a remaining portion;

advancing the heart valve sizer of the sizing tool to the aortic valve annulus;

determining the diameter of the aortic valve annulus by inserting the heart valve sizer into the aortic valve annulus;

assessing whether the severed coronary arteries are long enough to reach the conduit graft replica;

adding a tubular coronary extension segment to either of the severed coronary arteries that are not long enough to reach the conduit graft replica;

preparing the composite valved conduit for implant;

attaching the composite valved conduit between the aortic valve annulus and the remaining portion of the ascending aorta; and

forming anastomotic connections between the coronary arteries and the conduit graft.

2. The method of claim 1, wherein the conduit graft replica is mounted to slide on the shaft, and the method includes spacing the conduit graft replica on the shaft proximally away from the heart valve sizer during the steps of advancing the heart valve sizer and determining the diameter of the aortic valve annulus.

3. The method of claim 1, wherein the conduit graft replica has an outwardly-bulged portion simulating an outwardly-bulged distal region of the conduit graft, and the step of assessing involves assessing whether the severed coronary arteries are long enough to reach the outwardly-bulged portion.

4. The method of claim 3, wherein the outwardly-bulged portion of the conduit graft replica has at least one target marker indicating a location where one of the coronary arteries would attach to the outwardly-bulged distal region of the conduit graft once implanted.

5. The method of claim 3, wherein the outwardly-bulged portion of the conduit graft replica has three vertical marker lines and an equatorial marker line, and the step of assessing includes extending each severed coronary artery to the equatorial marker line between two of the three vertical marker lines.

6. The method of claim 1, wherein the heart valve sizer has a portion with a diameter that corresponds to a labeled size of the prosthetic heart valve, and the conduit graft replica has a diameter that is larger than the heart valve sizer portion diameter.

7. The method of claim 1, wherein the heart valve sizer has a diameter that corresponds to a labeled size of the prosthetic heart valve, and the step of determining the diameter of the aortic valve annulus includes inserting the heart valve sizer of a first sizing tool into the aortic valve annulus, removing the first sizing tool, and performing the steps of advancing and determining using a second sizing tool.

8. A method of sizing a patient'"'"'s aortic valve annulus and two coronary arteries for implant of a composite valved conduit having a prosthetic heart valve on a distal end attached to a conduit graft that extends to a proximal end, comprising:

obtaining a sizing tool having a distal heart valve sizer defining an axis and a conduit graft replica defining an axis and located proximal to the heart valve sizer;

accessing the patient'"'"'s heart;

severing the two coronary arteries from the patient'"'"'s ascending aorta;

resecting a section of the ascending aorta from a location adjacent to the aortic valve annulus to leave a remaining portion;

spacing the conduit graft replica proximally away from the heart valve sizer;

advancing the heart valve sizer of the sizing tool to the aortic valve annulus;

determining the diameter of the aortic valve annulus by inserting the heart valve sizer into the aortic valve annulus;

sliding the conduit graft replica into contact with the heart valve sizer and then assessing whether the severed coronary arteries are long enough to reach the conduit graft replica;

adding a tubular coronary extension segment to either of the severed coronary arteries that are not long enough to reach the conduit graft replica;

preparing the composite valved conduit for implant;

attaching the composite valved conduit between the aortic valve annulus and the remaining portion of the ascending aorta; and

forming anastomotic connections between the coronary arteries and the conduit graft.

9. The method of claim 8, wherein the sizing tool has a proximal handle and a shaft extending distally therefrom and includes a locking mechanism for fixing the position of the conduit graft replica spaced on the shaft proximally away from the heart valve sizer.

10. The method of claim 8, wherein the heart valve sizer has a portion with a diameter that corresponds to a labeled size of the prosthetic heart valve, and the conduit graft replica has an outwardly-bulged portion simulating an outwardly-bulged distal region of the conduit graft and the outwardly-bulged portion has a diameter that is larger than the heart valve sizer portion diameter.

11. The method of claim 8, wherein the heart valve sizer has a distal cylindrical portion and a proximal undulating flange with three peaks and three valleys around the heart valve sizer axis, and the step of determining the diameter of the aortic valve annulus includes rotating the heart valve sizer to align the peaks and valleys of the undulating flange with peaks and valleys of the aortic valve annulus.

12. The method of claim 8, wherein the heart valve sizer has a proximal face that has an undulating shape around the heart valve sizer axis and the conduit graft replica has a distal face that has an undulating shape around the conduit graft replica axis that mates with the proximal face of the heart valve sizer, and the step of assessing includes first sliding the conduit graft replica into contact with the heart valve sizer and rotating the conduit graft replica to ensure the distal face thereof mates with the proximal face of the heart valve sizer.

13. The method of claim 12, wherein the conduit graft replica has markers around the axis thereof indicating locations where the coronary arteries would attach to the conduit graft once implanted, wherein the step of rotating the conduit graft replica also orients the markers on the conduit graft replica to locations where the coronary arteries would attach to the conduit graft once implanted.

14. The method of claim 13, wherein the markers include three vertical marker lines and an equatorial marker line, and the step of assessing includes extending each severed coronary artery to the equatorial marker line between two of the three vertical marker lines.

15. A method of sizing a patient'"'"'s aortic valve annulus and two coronary arteries for implant of a composite valved conduit having a prosthetic heart valve on a distal end attached to a conduit graft that extends to a proximal end, comprising:

obtaining a sizing tool having a heart valve sizer on a distal end with a diameter that corresponds to a labeled size of the prosthetic heart valve, and a conduit graft replica located proximal to the heart valve sizer having an outwardly-bulged portion with a diameter that is larger than the heart valve sizer diameter;

accessing the patient'"'"'s heart;

severing the two coronary arteries from the patient'"'"'s ascending aorta;

resecting a section of the ascending aorta from a location adjacent to the aortic valve annulus to leave a remaining portion;

advancing the heart valve sizer of the sizing tool to the aortic valve annulus;

determining the diameter of the aortic valve annulus by inserting the heart valve sizer into the aortic valve annulus;

assessing whether the severed coronary arteries are long enough to reach respective target locations on the outwardly-bulged portion of the conduit graft replica;

adding a tubular coronary extension segment to either of the severed coronary arteries that are not long enough to reach the respective target location;

preparing the composite valved conduit for implant;

attaching the composite valved conduit between the aortic valve annulus and the remaining portion of the ascending aorta; and

forming anastomotic connections between the coronary arteries and the conduit graft.

16. The method of claim 15, wherein the conduit graft replica may be displaced relative to the heart valve sizer, and the method includes spacing the conduit graft replica on the shaft proximally away from the heart valve sizer during the steps of advancing the heart valve sizer and determining the diameter of the aortic valve annulus.

17. The method of claim 16, wherein the conduit graft replica has a distal face that mates with a proximal flange of the sizer in discrete relative rotational alignments, and the conduit graft replica has a plurality of markers on the outwardly-bulged portion around an axis thereof indicating locations where the coronary arteries would attach to the conduit graft once implanted, the method including ensuring the distal face of the conduit graft replica rotationally mates with the proximal flange of the sizer to orient the markers on the conduit graft replica.

18. The method of claim 15, wherein the heart valve sizer has a distal cylindrical portion defining the diameter and a proximal undulating flange with three peaks and three valleys around a heart valve sizer axis, and the step of determining the diameter of the aortic valve annulus includes rotating the heart valve sizer to align the peaks and valleys of the undulating flange with peaks and valleys of the aortic valve annulus.

19. The method of claim 18, wherein the conduit graft replica has a plurality of markers on the outwardly-bulged portion around an axis thereof, wherein the step of rotating the heart valve sizer also orients the markers on the conduit graft replica to locations where the coronary arteries would attach to the conduit graft once implanted.

20. The method of claim 19, wherein the markers include three vertical marker lines and an equatorial marker line, and the step of assessing includes extending each severed coronary artery to the equatorial marker line between two of the three vertical marker lines.