Prosthetic heart valve having identifiers for aiding in radiographic positioning

• US 9,943,407 B2
• Filed: 03/09/2015
• Issued: 04/17/2018
• Est. Priority Date: 09/15/2008
• Status: Active Grant

• Current Assignee: Medtronic Ventor Technologies LTD. (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Tuval, Yossi, Bernary, Raphael
• Primary Examiner(s): Matthews, Howie
• Application Number:
  US14/641,545
• Publication Number:
  US 20150182333A1
• Time in Patent Office: 1,135 Days
• 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

Methods for implanting a collapsible prosthetic heart valve having commissural posts including the steps of placement through a blood vessel, using a fluoroscopic image, and rotationally aligning at least one post with a native commissure.

Claims

1. A method comprising:

providing a valve prosthesis that includes a prosthetic heart valve, and exactly three 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 the 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;

wherein the valve prosthesis is configured to have threefold rotational symmetry;

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;

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 approximately 60 degrees to correct a rotational alignment of the valve prosthesis.

2. The method according to claim 1, 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.

3. The method according to claim 2, wherein the radiographic identifier has the shape of a reflection-asymmetric character.

4. The method according to claim 1, wherein the at least one of the commissural posts is shaped to define an opening therethrough which defines the radiographic identifier.

5. The method according to claim 1, 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.

6. The method according to claim 1, wherein the native commissures of the native heart valve includes a first native commissure between a left coronary sinus and a right coronary sinus of the native heart valve, and wherein rotationally aligning comprises rotationally aligning the one of the commissural posts with the first native commissure.

7. A method comprising:

providing a valve prosthesis that includes a prosthetic heart valve, and exactly three 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 the valve prosthesis is configured to have threefold rotational symmetry;

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;

wherein rotating the valve prosthesis to correct the rotational alignment comprises rotating the valve prosthesis approximately 60 degrees.

8. A method comprising:

providing a valve prosthesis that includes a prosthetic heart valve, and exactly three 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 the 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;

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;

wherein the valve is configured to have three-fold rotational symmetry;

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;

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;

wherein rotating the valve prosthesis to correct the rotational alignment comprises rotating the valve prosthesis approximately 60 degrees.