Prosthetic heart valve having identifiers for aiding in radiographic positioning

Patent metadata

Field	Value
Publication number	US-9943407-B2
Application number	US-201514641545-A
Country	US
Kind code	B2
Filing date	Mar 9, 2015
Priority date	Sep 15, 2008
Publication date	Apr 17, 2018
Grant date	Apr 17, 2018

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.

First claim

The invention claimed is:

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.

Assignees

• Medtronic Inc

Inventors

• Tuval Yossi
• Bernary Raphael

Classifications

• A61F2220/0016

  with sharp anchoring protrusions, e.g. barbs, pins, spikes · CPC title

• A61F2230/008

  paraboloidal · CPC title

• A61B34/20

  Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis · CPC title

• A61F2/2418 Primary

  Scaffolds therefor, e.g. support stents · CPC title

• A61F2230/0054

  V-shaped · CPC title