Granted Patent B1

US 12,295,841 · App. 19/021,911 · Granted May 13, 2025

Inventors: Yossi Tuval (Netanya, IL); Raphael Benary (Tel Aviv, IL)

Assignee: Medtronic, Inc.

A61F2/2427A61F2/2418A61F2/2436A61B34/20A61B2090/376A61F2220/0016A61F2220/0075A61F2230/005A61F2230/0054A61F2230/008A61F2250/0097A61F2250/0098

Abstract

Claims (37)

1. A method comprising:

delivering a valve prosthesis in a collapsed configuration in a catheter via a blood vessel of a subject to a vicinity of a functioning native heart valve of a heart of the subject using a retrograde approach, wherein the heart valve prosthesis includes a support structure and a prosthetic valve coupled to the support structure, wherein the support structure includes three engagement arms extending proximally and at least one imaging identifier;

generating an image of the functioning native heart valve and the valve prosthesis; and

rotationally aligning the engagement arms with sinuses of the functioning native heart valve using the at least one imaging identifier visible in the image.

2. The method of claim 1 , wherein the support structure further includes three commissural posts, wherein the at least one imaging identifier is coupled to the support structure at a location that is not on the commissural posts.

3. The method of claim 1 , wherein the at least one imaging identifier comprises exactly three imaging identifiers.

4. The method of claim 1 , wherein the at least one imaging identifier comprises a first material having a first radiopacity and the support structure comprises a second material having a second radiopacity, wherein the first radiopacity and the second radiopacity are different.

5. The method of claim 1 , further comprising radially expanding the engagement arms.

6. The method of claim 5 , wherein the support structure further includes a proximal portion, wherein during the delivering step the proximal portion is retained within a cap of the catheter, further comprising, after radially expanding the engagement arms, advancing the cap towards an apex of the heart to release the proximal portion of the support structure from the catheter, thereby enabling the proximal portion to expand to a radially expanded configuration.

7. The method of claim 6 , further comprising, after advancing the cap, retracting a catheter tube of the catheter to release an outflow portion of the valve prosthesis from the catheter tube.

8. The method of claim 1 , wherein the image is a radiographic image.

9. The method of claim 1 , wherein the image is a fluoroscopic image.

10. The method of claim 1 , wherein the imaging identifier has a reflection-asymmetric shape.

11. The method of claim 1 , wherein rotationally aligning comprises:

rotating the valve prosthesis;

observing whether the imaging identifier appears to move in the image in the same direction that the valve prosthesis is rotated, or in an opposite direction; and

if the imaging identifier appears to move in the image in the opposite direction, rotating the valve prosthesis approximately 60 degrees to correct a rotational alignment of the valve prosthesis.

12. The method of claim 1 , wherein rotationally aligning the engagement arms with sinuses comprises rotationally aligning a prosthetic heart valve commissure of the valve prosthesis with a native commissure of the functioning native heart valve using the at least one imaging identifier visible in the image.

13. The method of claim 12 , wherein the imaging identifier visible in the image is radially aligned with the prosthetic heart valve commissure.

14. A method comprising:

delivering a valve prosthesis in a collapsed configuration in a catheter via a blood vessel of a subject to a vicinity of a functioning native aortic heart valve of a heart of the subject using a retrograde approach, wherein the heart valve prosthesis includes,

a support structure having exactly three commissural posts, an inflow portion, and exactly three engagement arms extending proximally,

a prosthetic valve coupled to the support structure, the prosthetic valve having exactly three prosthetic valve leaflets coupled to the commissural posts, and

three imaging identifiers, wherein the three imaging identifiers are radiographic identifiers;

generating an image of the functioning native heart valve and the valve prosthesis;

rotationally aligning the valve prosthesis such that the engagement arms are aligned with aortic sinuses of the functioning native aortic heart valve using a first imaging identifier of the imaging identifiers visible in the image

radially expanding the engagement arms;

inserting the engagement arms into the aortic sinuses;

advancing a cap of the catheter towards an apex of the native aortic heart valve to release the inflow portion of the support structure from the cap, thereby enabling the inflow portion of the support structure to radially expand.

15. The method of claim 14 , wherein the three imaging identifiers are coupled to the support structure at a location that is not on the three commissural posts.

16. The method of claim 15 , wherein the three imaging identifiers are coupled to the inflow portion of the support structure.

17. The method of claim 14 , wherein the imaging identifiers are coupled to the commissural posts.

18. The method of claim 14 , wherein rotationally aligning comprises:

rotating the valve prosthesis;

observing whether the first imaging identifier appears to move in the image in the same direction that the valve prosthesis is rotated, or in an opposite direction; and

if the first imaging identifier appears to move in the image in the opposite direction, rotating the valve prosthesis approximately 60 degrees to correct a rotational alignment of the valve prosthesis.

19. The method of claim 14 , wherein rotationally aligning the valve prosthesis comprises rotationally aligning a prosthetic heart valve commissure of the valve prosthesis with a native commissure of the functioning native heart valve using the first imaging identifier visible in the image.

Assignments (1)

Continuity (6)

References Cited (400)