Prosthetic Heart Valve Having Identifiers for Aiding in Radiographic Positioning

• US 20100121436A1
• Filed: 09/15/2009
• Published: 05/13/2010
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Bernary, Raphael, Tuval, Yossi
• Granted Patent: US 8,998,981 B2
• Time in Patent Office: Days
• US Class Current: 623/2.170
• CPC Class Codes: A61B 2090/376 using X-rays, e.g. fluoroscopy
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• 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 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A prosthetic heart valve having identifiers for aiding in radiographic positioning is described.

Claims

1. Apparatus comprising a valve prosthesis, which comprises:

a prosthetic heart valve; and

three or more commissural posts, to which the prosthetic heart valve is coupled, which posts are arranged circumferentially around a central longitudinal axis of the valve prosthesis, and are configured to assume a collapsed position prior to implantation of the prosthesis, and an expanded position upon the implantation of the prosthesis,

wherein one or more of the commissural posts are provided with respective radiographic identifiers that are shaped to be reflection-asymmetric about respective post axes that are generally parallel with the central longitudinal axis when the posts assume the collapsed position.

2. The apparatus according to claim 1, wherein the radiographic identifiers have the shape of one or more reflection-asymmetric characters.

3. The apparatus according to claim 1, wherein the one or more of the commissural posts are shaped to define respective openings therethrough which define the respective radiographic identifiers.

4. The apparatus according to claim 1, wherein the radiographic identifiers comprise a material having a first radiopacity that is different from a second radiopacity of the commissural posts, which material is coupled to the one or more of the commissural posts.

5. The apparatus according to claim 1, wherein the valve prosthesis comprises exactly three commissural posts.

6. A method comprising:

providing a valve prosthesis that includes a prosthetic heart valve, and three or more commissural posts, to which the prosthetic heart valve is coupled, which posts are arranged circumferentially around a central longitudinal axis of the valve prosthesis, and are configured to assume a collapsed position prior to implantation of the prosthesis, and an expanded position upon the implantation of the prosthesis, and at least one of which commissural posts is provided with a radiographic identifier;

while the posts assume the collapsed position, placing, via a blood vessel of the subject, the valve prosthesis at least partially in a heart of a subject in a vicinity of a native heart valve having native commissures;

generating a fluoroscopic image of the native commissures and valve prosthesis; and

rotationally aligning the at least one of the commissural posts with one of the native commissures using the radiographic identifier visible in the image.

7. The method according to claim 6, wherein rotationally aligning comprises:

rotating the valve prosthesis;

observing whether the at least one of the commissural posts appears to move in the image in the same direction that the valve prosthesis is rotated, or in an opposite direction; and

if the at least one of the commissural posts appears to move in the image in the opposite direction, rotating the valve prosthesis to correct a rotational alignment of the valve prosthesis.

8. The method according to claim 7, wherein the valve prosthesis includes exactly three commissural posts, and is configured to have three-fold rotational symmetry, and wherein rotating the valve prosthesis to correct the rotational alignment comprises rotating the valve prosthesis approximately 60 degrees.

9. The method according to claim 6, wherein the radiographic identifier is shaped to be reflection-asymmetric about a post axis of the at least one of the commissural posts, which axis is generally parallel with the central longitudinal axis when the posts assume the collapsed position.

10. The method according to claim 9, wherein the radiographic identifier has the shape of a reflection-asymmetric character.

11. The method according to claim 9, wherein rotationally aligning comprises:

observing in the image whether the radiographic identifier appears in a correct left-right orientation; and

if the radiographic identifier does not appear in the correct left-right orientation, rotating the valve prosthesis to correct a rotational alignment of the valve prosthesis.

12. The method according to claim 11, wherein the valve prosthesis includes exactly three commissural posts, and is configured to have three-fold rotational symmetry, and wherein rotating the valve prosthesis to correct the rotational alignment comprises rotating the valve prosthesis approximately 60 degrees.

13. The method according to claim 6, wherein the at least one of the commissural posts is shaped to define an opening therethrough which defines the radiographic identifier.

14. The method according to claim 6, wherein the radiographic identifier comprises a material having a first radiopacity that is different from a second radiopacity of the at least one of the commissural posts, which material is coupled to the at least one of the commissural posts.

15. The method according to claim 6, wherein the one of the native commissures is a native commissure (C_RL) between a left coronary sinus and a right coronary sinus, and wherein rotationally aligning comprises rotationally aligned the one of the commissural posts with the C_RL.

16. A method comprising:

providing a valve prosthesis that includes a prosthetic heart valve, and three or more commissural posts, to which the prosthetic heart valve is coupled, which posts are arranged circumferentially around a central longitudinal axis of the valve prosthesis, and are configured to assume a collapsed position prior to implantation of the prosthesis, and an expanded position upon the implantation of the prosthesis;

while the posts assume the collapsed position, placing, via a blood vessel of the subject, the valve prosthesis at least partially in a heart of a subject in a vicinity of a native heart valve having native commissures;

generating a fluoroscopic image of the native commissures and valve prosthesis; and

rotationally aligning the at least one of the commissural posts with one of the native commissures by;

rotating the valve prosthesis,

observing whether the at least one of the commissural posts appears to move in the image in the same direction that the valve prosthesis is rotated, or in an opposite direction, and

if the at least one of the commissural posts appears to move in the image in the opposite direction, rotating the valve prosthesis to correct a rotational alignment of the valve prosthesis.

17. The method according to claim 16, wherein the valve prosthesis includes exactly three commissural posts, and is configured to have three-fold rotational symmetry, and wherein rotating the valve prosthesis to correct the rotational alignment comprises rotating the valve prosthesis approximately 60 degrees.

18. Apparatus comprising a valve prosthesis, which comprises:

a prosthetic heart valve;

a support structure, which comprises a first material having a first radiopacity; and

one or more radiographic identifiers, which comprise a second material having a second radiopacity different from the first radiopacity, and which are coupled to the support structure at respective locations.

19. The apparatus according to claim 18, wherein the radiographic identifiers are shaped to be reflection-asymmetric about respective identifier axes that are generally parallel with a central longitudinal axis of the valve prosthesis.

20. The apparatus according to claim 18, wherein the identifiers are arranged circumferentially around a central longitudinal axis of the valve prosthesis.

21. The apparatus according to claim 18, wherein the support structure is shaped so as to define a bulging proximal skirt, and wherein the identifiers are coupled to the skirt.

22. The apparatus according to claim 18, wherein the support structure comprises three or more commissural posts, to which the prosthetic heart valve is coupled, which posts are arranged circumferentially around a central longitudinal axis of the valve prosthesis, wherein the locations at which the identifiers are coupled to the support structure are not on the posts, and wherein the locations are radially aligned with the posts.

23. The apparatus according to claim 18, wherein the support structure comprises three or more commissural posts, to which the prosthetic heart valve is coupled, which posts are arranged circumferentially around a central longitudinal axis of the valve prosthesis, wherein the locations at which the identifiers are coupled to the support structure are on the posts.