Systems and methods for positioning a heart valve using visual markers

• US 9,579,197 B2
• Filed: 12/14/2011
• Issued: 02/28/2017
• Est. Priority Date: 12/15/2010
• Status: Active Grant

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Duffy, Niall, McCaffrey, Gerry, Miller, Noam, Tuval, Yossi, Glozman, Daniel
• Primary Examiner(s): Rosen, Eric
• Assistant Examiner(s): PAEZ, LUCAS M
• Application Number:
  US13/325,439
• Publication Number:
  US 20120158129A1
• Time in Patent Office: 1,903 Days
• Field of Search: 623/1.11, 623/2.11, 623/2.12, 623/2.17
• US Class Current: 1/1
• 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 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2250/0032 differing in radiographic density
• 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 valve retainer is connected to an elongate delivery member. The valve retainer is configured to releasably secure a prosthesis (e.g., a heart valve prosthesis) to the delivery member during delivery to a target site in a body (e.g., a native valve annulus). The valve retainer includes a rotational identifier that identifies the rotational orientation of the valve retainer when the valve retainer is positioned proximate to the target site. A heart valve prosthesis can include a commissural post that has a predetermined rotational position relative to the rotational identifier, such that the heart valve prosthesis can be rotationally aligned with the native commissures of the native valve by rotating the delivery member and the valve retainer until the commissural post is aligned with a native valve commissure and the rotational identifier is visible.

Claims

1. An assembly for delivering an implantable prosthesis to a target site in a body, the assembly comprising:

an elongate inner delivery member disposed within an outer shaft, the elongated delivery member including a longitudinal axis; and

a valve retainer connected to the elongate inner delivery member and disposed within the outer shaft during delivery to a target site in the body, wherein the valve retainer has an outer surface, wherein the valve retainer is configured to releasably secure a proximal end of a prosthesis to the elongate inner delivery member during delivery to the target site in a body, and

wherein the valve retainer includes a rotational identifier that identifies the rotational orientation of the valve retainer around the longitudinal axis when the valve retainer is positioned proximate to the target site in the body, wherein the rotational identifier is a notch formed in the outer surface of the valve retainer such that the valve retainer is asymmetric relative to the longitudinal axis.

2. The assembly of claim 1, wherein the notch extends approximately 180 degrees around the outer surface of the valve retainer.

3. The assembly of claim 1, wherein the valve retainer includes a distal surface and a proximal surface, and wherein the distal surface includes a prosthesis retaining slot.

4. The assembly of claim 3 further comprising a heart valve prosthesis configured to be releasably secured by the valve retainer, wherein the heart valve prosthesis includes a support member and a valve member, wherein the support member includes a commissural post.

5. The assembly of claim 4, wherein the heart valve prosthesis includes a connection member, and wherein the prosthesis retaining slot of the valve retainer is configured to receive and secure the connection member of the heart valve prosthesis.

6. The assembly of claim 5, wherein the commissural post is positioned on the support member such that when the connection member is secured within the prosthesis retaining slot and the rotational identifier is visible, the commissural post has a predetermined rotational position relative to the rotational identifier.

7. The assembly of claim 6, wherein the heart valve prosthesis includes three commissural posts and three engagement arms, and wherein each of the engagement arms is configured to engage a native aortic sinus.

8. A method for implanting a heart valve prosthesis in a body, the method comprising:

advancing a delivery system to a native valve annulus in a body, wherein the delivery system includes

an outer shaft,

an elongate inner delivery member disposed within the outer shaft, the elongate inner delivery member having a longitudinal axis, a distal end and proximal end,

a valve retainer connected to the elongate inner delivery member and disposed within the outer shaft, wherein the valve retainer has an outer surface, wherein the valve retainer includes a rotational identifier that identifies the rotational orientation of the valve retainer around the longitudinal axis when the valve retainer is positioned proximate to a target site in a body, wherein the rotational identifier is a notch formed in the outer surface of the valve retainer such that the valve retainer is asymmetric relative to the longitudinal axis, and

a heart valve prosthesis having a proximal end releasably secured to the valve retainer, wherein the heart valve prosthesis includes a commissural post;

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

rotationally aligning the heart valve prosthesis by rotating the elongate inner delivery member and the valve retainer until the commissural post is aligned with a native valve commissure and the rotational identifier is visible on a predetermined side of the valve retainer such that the rotational position of the commissural post with respect to the rotational identifier is known.

9. The method of claim 8, wherein the commissural post of the heart valve prosthesis further includes a radiographic identifier.

10. The method of claim 9, wherein the radiographic identifier is visible in the fluoroscopic image.

11. The method of claim 8, wherein the notch extends approximately 180 degrees around the outer surface of the valve retainer.

12. The method of claim 8, wherein the heart valve prosthesis includes three commissural posts and three engagement arms, and wherein each of the engagement arms is configured to engage a native aortic sinus.

13. An apparatus comprising:

a valve prosthesis comprising;

a prosthetic heart valve,

a support structure, wherein the support structure includes a first material having a first radiopacity, and

one or more radiographic identifiers, wherein the radiographic identifiers include a second material having a second radiopacity different from the first radiopacity,

an elongate inner delivery member disposed within an outer shaft and having a longitudinal axis; and

a valve retainer connected to the elongate inner delivery member and disposed within the outer shaft, wherein the valve retainer has an outer surface, wherein the valve retainer is configured to releasably secure a proximal end the heart valve prosthesis to the elongate inner delivery member during delivery to a target site in a body,

wherein the valve retainer includes a rotational identifier that identifies the rotational orientation of the valve retainer around the longitudinal axis when the valve retainer is positioned proximate to the target site in the body, wherein the rotational identifier includes a notch on the other surface of the valve retainer such that the valve retainer is asymmetric relative to the longitudinal axis.

14. The apparatus of claim 13, wherein the rotational identifier includes a radiopaque material.

15. The apparatus of claim 13, wherein the valve prosthesis includes three commissural posts and three engagement arms, wherein each of the engagement arms is configured to engage a native aortic sinus.