EXPANDABLE RADIOPAQUE MARKER FOR TRANSCATHETER AORTIC VALVE IMPLANTATION

• US 20130073032A1
• Filed: 07/19/2012
• Published: 03/21/2013
• Est. Priority Date: 07/28/2011
• Status: Active Grant

• Current Assignee: St Jude Medical LLC (Abbott Laboratories)
• Original Assignee: St Jude Medical Incorporated (Abbott Laboratories)
• Inventors: Wang, Huisun
• Granted Patent: US 9,370,422 B2
• Time in Patent Office: Days
• US Class Current: 623/2.11
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/243 Deployment by mechanical expansion
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2/246 Devices for obstructing a leak through a native valve in a closed condition
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A delivery device for a collapsible prosthetic heart valve includes a support shaft around which a compartment for the valve is defined, a distal sheath adapted to selectively cover and uncover the compartment and the valve, and a marker cage having a collapsed condition when the distal sheath covers the compartment and an expanded condition when the compartment is uncovered. The marker cage includes at least one rib having a radiopaque marker for determining the positioning of the valve as it is deployed. The valve may be assembled around the marker cage so that the marker cage does not interfere with the radial expansion of the valve during deployment.

Claims

1. A delivery device for a collapsible prosthetic heart valve, the delivery device comprising:

a support shaft around which a compartment is defined, the compartment being adapted to receive the valve in an assembled condition;

a distal sheath adapted to selectively cover and uncover the compartment and the valve;

a marker cage having a collapsed condition when the distal sheath covers the compartment and an expanded condition when the compartment is uncovered, the marker cage being adapted to engage the valve in the assembled condition; and

at least one radiopaque marker on the marker cage.

2. The delivery device of claim 1, wherein each radiopaque marker includes a material selected from the group consisting of gold, platinum, nitinol, and combinations thereof.

3. The delivery device of claim 1, wherein the marker cage is formed from a memory material tube having an aperture extending therethrough.

4. The delivery device of claim 1, wherein the marker cage has a first end fixedly connected to the support shaft and at least one rib having a fixed end connected to the first end.

5. The delivery device of claim 4, wherein the marker cage has a second end slidably connected to the support shaft, and the at least one rib has another end connected to the second end.

6. The delivery device of claim 4, wherein the marker cage has a second end fixedly connected to the support shaft, and the at least one rib has another end connected to the second end.

7. The delivery device of claim 4, wherein the at least one rib has a free end opposite the fixed end.

8. The delivery device of claim 4, wherein substantially all of the at least one rib is radiopaque or is surrounded by a radiopaque material.

9. The delivery device of claim 4, wherein the at least one rib is adapted to be engaged between adjacent leaflets of the valve in the assembled condition.

10. The delivery device of claim 9, wherein the prosthetic heart valve includes a tissue cuff having a longitudinal axis, and the at least one marker is adapted to be oriented substantially parallel to the longitudinal axis in the assembled condition.

11. The delivery device of claim 1, wherein the marker cage has an expanded diameter that is greater than an expanded diameter of the prosthetic heart valve.

12. The delivery device of claim 4, wherein the marker cage includes a plurality of ribs disposed around a longitudinal axis of the support shaft, each rib having at least one radiopaque marker, the radiopaque markers being positioned equidistantly from the longitudinal axis in an expanded condition of the marker cage.

13. The delivery device of claim 4, wherein the at least one rib has first and second legs, the first leg having one end connected to the first end of the marker cage and another end, the second leg having a first end connected to the another end of the first leg and a second end, wherein the second leg extends substantially parallel to the support shaft when the marker cage is in the expanded condition.

14. The delivery device of claim 13, wherein the marker cage has a second end slidably connected to the support shaft, and the at least one rib further includes a third leg having one end connected to the second end of the second leg and another end connected to the second end of the marker cage, wherein the first and third legs of the at least one rib extend in substantially opposite transverse directions to the support shaft when the marker cage is in the expanded condition.

15. A marker cage for use in deployment of a collapsible prosthetic heart valve, the marker cage comprising:

a first end;

at least one rib having one end connected to the first end; and

at least one radiopaque marker,

the marker cage having a collapsed condition and an expanded condition and being adapted to engage the valve in an assembled condition.

16. The marker cage of claim 15, wherein each radiopaque marker includes a material selected from the group consisting of gold, platinum, nitinol, and combinations thereof.

17. The marker cage of claim 15, wherein the marker cage is formed from a memory material tube having an aperture extending therethrough.

18. The marker cage of claim 15, further comprising a second end, the at least one rib having another end connected to the second end.

19. The marker cage of claim 15, wherein the at least one rib has a free end opposite the one end.

20. The marker cage of claim 15, wherein substantially all of the at least one rib is radiopaque or is surrounded by a radiopaque material.

21. The marker cage of claim 15, wherein the marker cage has an expanded diameter that is greater than an expanded diameter of the prosthetic heart valve.

22. The marker cage of claim 15, wherein the marker cage includes a plurality of ribs disposed around a longitudinal axis, each rib having at least one radiopaque marker, the radiopaque markers being positioned equidistantly from the longitudinal axis in an expanded condition of the marker cage.

23. The marker cage of claim 15, wherein the at least one rib has first and second legs, the first leg having one end connected to the first end of the marker cage and another end, the second leg having a first end connected to the another end of the first leg and a second end, wherein the second leg extends substantially parallel to a longitudinal axis of the marker cage when the marker cage is in the expanded condition.

24. The marker cage of claim 23, wherein the marker cage has a second end, and the at least one rib further includes a third leg having one end connected to the second end of the second leg and another end connected to the second end of the marker cage, wherein the first and third legs of the at least one rib extend in substantially opposite transverse directions to the longitudinal axis when the marker cage is in the expanded condition.

25. A method of determining the position of a collapsible prosthetic heart valve in a patient, the method comprising:

providing a delivery device including a support shaft around which a compartment is defined, a distal sheath adapted to selectively cover and uncover the compartment, and a marker cage including at least one radiopaque marker and having a collapsed condition when the distal sheath covers the compartment and an expanded condition when the compartment is uncovered;

mounting a collapsible prosthetic heart valve in the compartment so that the marker cage is positioned within the valve;

sliding the distal sheath to cover the compartment and the valve, and to maintain the marker cage in the collapsed condition;

inserting the delivery device into the patient;

positioning the delivery device so that the valve is positioned at a target location within the patient;

partially deploying the valve by sliding the distal sheath to partially uncover the compartment and the valve;

determining the position of the at least one marker relative to a native valve annulus of the patient;

fully deploying the valve by continuing to slide the distal sheath to fully uncover the valve, whereupon the marker cage will be in the expanded condition; and

compressing the marker cage to the collapsed condition by sliding the distal sheath to at least partially cover the compartment and the marker cage.

26. The method of claim 25, wherein the marker cage has a first end fixedly connected to the support shaft and at least one rib having a fixed end connected to the first end.

27. The method of claim 26, wherein the marker cage includes a plurality of ribs disposed around a longitudinal axis of the support shaft, each rib having at least one radiopaque marker, the radiopaque markers being positioned equidistantly from the longitudinal axis in an expanded condition of the marker cage.

28. The method of claim 27, wherein the steps of partially deploying and fully deploying include expanding the marker cage with each rib positioned between adjacent leaflets of the valve.

29. The method of claim 28, wherein the compressing step includes compressing the marker cage during a portion of the heart beat cycle when blood is flowing through the leaflets of the valve.

30. The method of claim 27, wherein the prosthetic heart valve includes a tissue cuff having a longitudinal axis, and the steps of partially deploying and fully deploying include expanding the marker cage with the at least one marker oriented substantially parallel to the longitudinal axis.