AORTIC VALVE POSITIONING SYSTEMS, DEVICES, AND METHODS

• US 20130109960A1
• Filed: 11/01/2012
• Published: 05/02/2013
• Est. Priority Date: 11/01/2011
• Status: Active Grant

• Current Assignee: Vascular Solutions Incorporated
• Original Assignee: Vascular Solutions Incorporated
• Inventors: Stinis, Curtiss T.
• Granted Patent: US 9,078,993 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 6/508 for non-human patients
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2439 Expansion controlled by filaments
• CPC Class Codes: A61F 2250/0008 for adjusting a position by translation along an axis or two perpendicular axes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 31/005 for contrast media

Abstract

Systems, devices, and methods for locating a geometric plane within a patient'"'"'s vasculature, for example, an entry plane to a valve, are disclosed. In one example, a medical device can include a body member and an expandable element. The body member can extend along a longitudinal axis of the medical device and at least partially define a lumen. The body member can include at least one opening disposed in fluid communication with the lumen. The expandable element can include at least two radiographic markers and can be movable between at least a first configuration and a second configuration. The at least two radiographic markers can be disposed within the lumen when the expandable element is in the first configuration. The at least two radiographic members can be disposed outside of the lumen and can be radially offset from the longitudinal axis when the expandable element is in the second configuration.

Claims

1. A medical device comprising:

a body member extending along a longitudinal axis, the body member at least partially defining a lumen and having an opening disposed in communication with the lumen; and

an expandable element including at least two radiographic markers, the expandable element movable between at least a first configuration, in which the at least two radiographic markers are disposed within the lumen, and a second configuration, in which the at least two radiographic markers are disposed outside of the lumen and are radially offset from the longitudinal axis,

wherein the at least two radiographic markers pass through the opening when the expandable element moves between the first configuration and the second configuration.

2. The medical device of claim 1, wherein the expandable element includes three radiographic markers.

3. The medical device of claim 2, wherein the three radiographic markers are equally radially offset from the longitudinal axis or equally longitudinally spaced from the opening of the body member when the expandable element is at the second configuration.

4. The medical device of claim 2, wherein the three radiographic markers define a geometric plane when the expandable element is at the second configuration.

5. The medical device of claim 2, wherein the expandable element includes three members, with each member including a radiographic marker.

6. The medical device of claim 5, wherein each radiographic marker is disposed on a tip portion of a member.

7. The medical device of claim 6, wherein each tip portion is sized and shaped to complement, and be received by, an aortic valve cusp.

8. The medical device of claim 7, wherein at least one tip portion includes a pigtail shape or a J-shape.

9. The medical device of claim 1, wherein the body member includes a tip portion, and wherein the opening is longitudinally offset from the tip portion along the body member.

10. The medical device of claim 9, further comprising a radiographic marker coupled to or integrated with the tip portion.

11. The medical device of claim 10, wherein the expandable element includes two members, and wherein each member includes a radiographic marker at an end portion.

12. The medical device of claim 11, wherein the radiographic markers of the expandable element and the radiographic marker of the tip portion are equally radially offset from the longitudinal axis when the expandable element is at the second configuration.

13. The medical device of claim 11, wherein the radiographic markers of the expandable element and the radiographic marker of the tip portion define a geometric plane when the expandable element is at the second configuration.

14. The medical device of claim 11, wherein the tip portion and the end portions are sized and shaped to complement, and be received by, an aortic valve cusp.

15. The medical device of claim 14, wherein at least one of the tip portion and the end portions includes a pigtail shape or a J-shape.

16. The medical device of claim 9, wherein the tip portion includes at least one port disposed in fluid communication with the lumen.

17. A catheter comprising:

a body member extending along a longitudinal axis, the body member at least partially defining a lumen and having an opening disposed in communication with the lumen; and

an expandable element including at least two radiographic markers and at least two members, the expandable element movable between at least a first configuration, in which the at least two radiographic markers are disposed within the lumen, and a second configuration, in which the at least two radiographic markers are disposed outside of the lumen and are radially offset from the longitudinal axis,

wherein the at least two radiographic markers pass through the opening when the expandable element moves between the first configuration and the second configuration, and

wherein the members are flexible such that rotational manipulation, applied at a proximal end of the body member post-implant, leads a distal tip of each member to a location at or near a lowest point of an aortic valve cusp.

18. A method comprising:

introducing at least three radiographic markers into a vessel;

advancing the at least three radiographic markers to a target location in the vessel;

defining a geometric plane at the target location using the at least three radiographic markers; and

manipulating a radiographic imaging device, configured to produce a radiographic image, including producing a radiographic image in which the at least three radiographic markers are disposed in a common line segment.

19. The method of claim 18, wherein advancing the at least three radiographic markers to the target location includes moving an expandable element from a first configuration, in which at least two of the radiographic markers are disposed within a body member lumen, and a second configuration, in which the at least two of the radiographic markers are disposed outside of the body member lumen.

20. The method of claim 18, wherein defining the geometric plane at the target location includes disposing each radiographic marker proximal to a nadir of an aortic cusp in a patient.

21. The method of claim 18, wherein providing the radiographic image in which the at least three radiographic markers are disposed in the common line segment includes identifying at least one dimension of the geometric plane.

22. The method of claim 18, further comprising advancing an aortic valve prosthesis through the vessel and positioning the aortic valve prosthesis adjacent the target location.

23. The method of claim 22, wherein positioning the aortic valve prosthesis includes positioning a first portion of the aortic valve prosthesis on a first side of the geometric plane and positioning a second portion of the aortic valve prosthesis on a second side of the geometric plane, which is opposite to the first side.