Aortic valve positioning systems, devices, and methods

• US 9,078,993 B2
• Filed: 11/01/2012
• Issued: 07/14/2015
• Est. Priority Date: 11/01/2011
• Status: Active Grant

• Current Assignee: Vascular Solutions Incorporated
• Original Assignee: Vascular Solutions Incorporated
• Inventors: Stinis, Curtiss T
• Primary Examiner(s): MEHTA, PARIKHA SOLANKI
• Application Number:
  US13/666,700
• Publication Number:
  US 20130109960A1
• Time in Patent Office: 985 Days
• US Class Current: 1/1
• 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 and defining a lumen having an opening;

an expandable element, at least partially disposed within the lumen, extending from a proximal end portion to a distal end portion and including a plurality of flexible members and radiographic markers, a distal tip portion of each flexible member including a pigtail shape or a J-shape having a distal most curvature to which a radiopaque marker is disposed or integrated; and

a knob engaged with the proximal end portion of the expandable element, the knob, when actuated, configured to move the expandable element back and forth between a first configuration, in which the plurality of radiographic markers are disposed within the lumen, and a second configuration, in which the plurality of radiographic markers are disposed outside of the lumen,

wherein the plurality of radiographic markers pass through the opening of the body member when the expandable element moves between the first configuration and the second configuration.

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

3. The medical device of claim 2, wherein the three radiographic markers are equally radially offset from the longitudinal axis of the body member 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 form a common line, indicative of at least one dimension along an entry plane to an aortic root, when the expandable element is at the second configuration.

5. The medical device of claim 2, wherein the plurality of flexible members includes three flexible members.

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

7. The medical device of claim 6, further comprising a radiographic marker coupled to or integrated with the distal tip portion of the body member.

8. The medical device of claim 7, wherein the plurality of flexible members includes two flexible members.

9. The medical device of claim 8, wherein the radiographic markers of the two flexible members and the radiographic marker of the distal tip portion of the body member are equally radially offset from the longitudinal axis of the body member when the expandable element is at the second configuration.

10. The medical device of claim 8, wherein the radiographic markers of the two flexible members and the radiographic marker of the distal tip portion of the body member form a common line, indicative of at least one dimension along an entry plane to an aortic root, when the expandable element is at the second configuration.

11. The medical device of claim 8, wherein the distal tip portion of the body member is sized and shaped to complement and be received by an aortic valve cusp.

12. The medical device of claim 11, wherein the distal tip portion of the body member includes a pigtail shape or a J-shape.

13. The medical device of claim 6, wherein the distal tip portion of the body member includes at least one port disposed in fluid communication with the lumen.

14. The medical device of claim 1, wherein the plurality of flexible members are configured such that rotational manipulation, applied at the proximal end portion of the expandable member post-implant, leads the radiographic marker of each flexible member to a location at or near a lowest point of a respective aortic valve cusp.

15. The medical device of claim 1, wherein the knob is disposed at a proximal end portion of the body member and is movable within a track or slot in a wall of the body member.

16. A method comprising:

introducing at least three radiographic markers into a vessel;

advancing each of the at least three radiographic markers to one of a plurality of aortic valve cusps, including moving an expandable element from a first configuration, in which at least two of the radiographic markers are disposed within a body member lumen, to a second configuration, in which the at least two radiographic markers are disposed outside of the body member lumen;

with the expandable element at the second configuration, defining a geometric plane at the aortic valve cusps using the at least three radiographic markers; and

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

17. The method of claim 16, wherein defining the geometric plane at the aortic valve cusps includes disposing each radiographic marker in direct contact with a nadir of a respective aortic valve cusp.

18. The method of claim 16, 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.

19. The method of claim 16, further comprising advancing an aortic valve prosthesis through the vessel and positioning the aortic valve prosthesis adjacent the aortic valve cusps.

20. The method of claim 19, 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.

21. The method of claim 16, wherein moving the expandable element from the first configuration to the second configuration includes moving a knob engaged with the proximal end portion of the expandable element.

22. The method of claim 21, wherein moving the knob includes rotating the knob.