Aortic valve positioning systems, devices, and methods

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.

1 . (canceled) 
     
     
         2 . A medical device, comprising:
 a body member extending along a longitudinal axis and defining at least one lumen;   a plurality of flexible members, at least partially disposed within the at least one lumen, extending from a proximal end portion to a distal end portion, a distal tip 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 moveably engaged with the proximal end portion of each flexible member, the knob, when actuated, configured to move the flexible members back and forth between a first configuration, in which the radiographic marker of each flexible member is disposed within the at least one lumen, and a second configuration, in which the radiographic marker of each flexible member is disposed outside of the at least one lumen,   wherein the radiographic markers pass through an opening of the at least one lumen when the flexible members move between the first configuration and the second configuration.   
     
     
         3 . The medical device of  claim 2 , wherein the plurality of flexible members includes three flexible members on which three radiographic markers are disposed or integrated. 
     
     
         4 . The medical device of  claim 3 , wherein the three radiographic markers are equally radially offset from the longitudinal axis of the body member when the flexible members are at the second configuration. 
     
     
         5 . The medical device of  claim 3 , 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 flexible members are at the second configuration. 
     
     
         6 . The medical device of  claim 2 , wherein the body member includes a distal tip portion, and wherein the opening of the least one lumen 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 are equally radially offset from the longitudinal axis of the body member when the flexible members are 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 flexible members are 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 2 , wherein the plurality of flexible members are configured such that rotational manipulation, applied at the proximal end portion of each flexible 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. 
     
     
         14 . The medical device of  claim 2 , 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. 
     
     
         15 . 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 a plurality of flexible members from a first configuration, in which at least two of the radiographic markers are disposed within at least one body member lumen, to a second configuration, in which the at least two radiographic markers are disposed outside of the at least one body member lumen;   with the flexible members 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.   
     
     
         16 . The method of  claim 15 , 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. 
     
     
         17 . The method of  claim 15 , 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. 
     
     
         18 . The method of  claim 15 , further comprising advancing an aortic valve prosthesis through the vessel and positioning the aortic valve prosthesis adjacent the aortic valve cusps. 
     
     
         19 . The method of  claim 15 , 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. 
     
     
         20 . The method of  claim 15 , wherein moving the flexible members from the first configuration to the second configuration includes moving a knob engaged with the proximal end portion of each flexible member. 
     
     
         21 . The method of  claim 20 , wherein moving the knob includes rotating the knob.