Delivery system having an integral centering mechanism for positioning a valve prosthesis in situ
Embodiments hereof relate to a delivery system for a transcatheter valve prosthesis, the delivery system having an integral centering mechanism to circumferentially center both the delivery system and the valve prosthesis within a vessel at the target implantation site. The centering mechanism may include expandable wings that may be selectively aligned with openings formed through a sidewall of an outer shaft of the delivery system, a coiled wing that may be selectively exposed through an opening formed through a sidewall of an outer shaft of the delivery system, a plurality of elongated filaments extending through a plurality of lumens of an outermost shaft of the delivery system that may be selectively deployed or expanded, an outer shaft that includes at least one pre-formed deflection segment formed thereon, a tool having a deployable lever arm, and/or a plurality of loops deployable via simultaneous longitudinal and rotational movement.
1 . A tool for use with a delivery system for a valve prosthesis configured for delivery within a vasculature, the tool comprising:
a shaft component defining a lumen, the shaft component having a proximal end and a distal end;
a handle coupled to the proximal end of the shaft component;
a lever arm coupled to the distal end of the shaft component, the lever arm having a first end attached to an outer surface of the shaft component, wherein when
the lever arm is in a delivery configuration a second end of the lever arm is detachably coupled to the outer surface of the shaft component and the lever arm has a straightened profile that is flush against the outer surface of the shaft component and when the lever arm is in an expanded configuration the second end of the lever arm is detached from the shaft component and the second end of the lever arm expands radially away from the shaft component such that the lever arm forms an acute angle with respect to the outer surface of the shaft component; and
wherein the shaft component includes a window formed through a sidewall thereof, the window being in fluid communication with the lumen, and wherein the tool further includes a pull wire extending within the lumen of the shaft component and through the window of the shaft component with a proximal end thereof being attached to a trigger of the handle and a distal end thereof being attached to the lever arm.
2 . The tool of claim 1 , wherein the shaft component is configured to be slidingly positioned over the delivery system.
3 . The tool of claim 1 , wherein the shaft component is integrated onto the delivery system.
4 . The tool of claim 1 , wherein the second end of the lever arm is atraumatic.
5 . The tool of claim 1 , wherein tensioning of the pull wire moves the lever arm from the delivery configuration to the expanded configuration.
6 . The tool of claim 1 , wherein a distal portion of the pull wire is positioned exterior to the shaft component and the remaining length of the pull wire is positioned within the lumen of the shaft component.
7 . The tool of claim 1 , wherein the trigger is operable to retract the pull wire.
8 . The tool of claim 1 , wherein the lever arm includes a cut-out portion forming an integral tab and a distal end of the pull wire is attached to the integral tab.
9 . The tool of claim 8 , wherein the integral tab is configured to bow radially outward when the pull wire is retracted such that the second end of the lever arm is deflected radially outward in the expanded configuration.
10 . The tool of claim 1 , further compromising a hinge positioned on the outer surface of the shaft component, the hinge extending over the proximal end of the lever arm, wherein the distal end of the pull wire is attached to an exterior surface of the lever arm.
11 . The tool of claim 10 , wherein the lever arm bends and deforms underneath the hinge when the pull wire is retracted such that the second end of the lever arm flares radially outward to in the expanded configuration.
12 . The tool of claim 10 , wherein the lever arm is formed from a self-expanding material that is shape-set in the delivery configuration.
13 . The tool of claim 12 , where the lever arm is configured to collapse and return to the delivery configuration when tension is removed from the pull wire.
14 . The tool of claim 1 , wherein the lever arm in the expanded configuration is configured to apply a spring force against a vessel wall of the vasculature in situ.
15 . The tool of claim 14 , wherein the lever arm in the expanded configuration is curved.
16 . The tool of claim 1 , wherein the second end of the lever arm has rounded edges.
17 . The tool of claim 1 , wherein the lever arm is configured to push the delivery system away from a vessel wall of the vasculature in situ and center the delivery system within the vessel.