ENDOVASCULAR DEVICES AND METHODS FOR EXPLOITING INTRAMURAL SPACE
Devices and methods for exploiting intramural (e.g., subintimal) space of a vascular wall to facilitate the treatment of vascular disease, particularly total occlusions. For example, the devices and methods disclosed herein may be used to visually define the vessel wall boundary, protect the vessel wall boundary from perforation, bypass an occlusion, and/or remove an occlusion.
1 . An orienting device for exploiting intramural space, comprising:
an elongate shaft having a distal end region and a lumen extending therethrough;
an orienting element disposed at the distal end region of the elongate shaft, the orienting element including an expandable structure configured to expand from a first configuration to a second configuration;
a deflectable distal tip disposed distal of the orienting element, the deflectable distal tip having a distal opening in communication with the lumen of the elongate shaft; and
a tension member secured to the bi-deflectable distal tip and extending proximally through the elongate shaft, wherein manipulation of the tension member causes the deflectable distal tip to deflect the distal opening.
2 . The orienting device of claim 1 , wherein the elongate shaft includes an articulation zone located between the deflectable distal tip and the orienting element.
3 . The orienting device of claim 2 , wherein the articulation zone includes a plurality of slots.
4 . The orienting device of claim 1 , wherein the elongate shaft includes an outer tubular member and an inner tubular member extending axially through the outer tubular member.
5 . The orienting device of claim 4 , wherein the tension member extending along the elongate shaft between the inner tubular member and the outer tubular member.
6 . An orienting device for exploiting intramural space, comprising:
an elongate shaft comprising an outer tubular layer and an inner tubular layer extending axially through the outer tubular layer, the inner tubular layer defining a lumen extending therethrough;
an orienting element disposed about the inner tubular layer distal of the outer tubular layer, the orienting element including oppositely opposed wings connected to each other at a proximal end of the orienting element and connected to each other at a distal end of the orienting element; and
a first tension member extending proximally between the outer tubular layer and the inner tubular layer from the distal end of the orienting element to a proximal end of the elongate shaft;
wherein the orienting element is configured to shift between a collapsed delivery configuration and an expanded deployed configuration via longitudinal displacement of the first tension member;
wherein in the expanded deployed configuration, the wings extend laterally from the elongate shaft in opposite directions, wherein the orienting element has a substantially planar shape defining a first plane in the expanded deployed configuration;
wherein the elongate shaft includes a bi-directional distal tip configured to direct the lumen of the inner tubular layer within a second plane oriented generally perpendicular to the first plane.
7 . The orienting device of claim 6 , wherein the proximal end of the orienting element is fixedly attached to the inner tubular layer by a proximal collar disposed around the inner tubular layer and the distal end of the orienting element is fixedly connected to a distal collar slidably disposed around the inner tubular layer
8 . The orienting device of claim 7 , wherein the tension member is fixedly attached to the distal collar.
9 . The orienting device of claim 6 , wherein the wings are oriented parallel to the elongate shaft.
10 . The orienting device of claim 6 , wherein the inner tubular layer includes a helical coil proximal of the orienting element and an annular tube distal of the orienting element.
11 . The orienting device of claim 6 , wherein a distal section of the inner tubular layer includes a plurality of cutouts forming an articulation zone.
12 . The orienting device of claim 11 , wherein the distal end of the orienting element is disposed about the articulation zone in the collapsed delivery configuration.
13 . The orienting device of claim 6 , further comprising two second tension members axially extending from the bi-directional distal tip to the proximal end of the elongate shaft.
14 . The orienting device of claim 13 , wherein the two second tension members are disposed on opposite sides of the elongate shaft.
15 . The orienting device of claim 13 , wherein the two second tension members are slidably disposed between the inner tubular layer and the outer tubular layer.
16 . An orienting device for exploiting intramural space, comprising:
an elongate shaft comprising an outer tubular layer and an inner tubular layer extending axially through the outer tubular layer, the inner tubular layer defining a lumen extending therethrough along a central longitudinal axis;
an orienting element disposed about the inner tubular layer distal of the outer tubular layer, the orienting element including a first laterally extendable wing and a second laterally extendable wing connected to each other at a proximal end of the orienting element and connected to each other at a distal end of the orienting element; and
a first tension member extending proximally between the outer tubular layer and the inner tubular layer from the distal end of the orienting element to a proximal end of the elongate shaft;
wherein the orienting element is configured to shift between a collapsed delivery configuration and an expanded deployed configuration via longitudinal displacement of the tension member;
wherein in the expanded deployed configuration, the first laterally extendable wing extends laterally away from the inner tubular layer in a first direction and the second laterally extendable wing extends laterally away from the inner tubular layer a second direction 180 degrees opposite the first direction such that the first laterally extendable wing and the second laterally extendable wing lie in a first plane;
wherein the elongate shaft includes a bi-directional distal tip defining an opening at a distal end of the lumen of the inner tubular member;
wherein the opening is oriented coaxially with the lumen of the inner tubular member in collapsed delivery configuration;
wherein the bi-directional tip is configured to direct the opening away from the central longitudinal axis in a third direction generally perpendicular to the first plane in the deployed configuration.
17 . The orienting device of claim 16 , wherein the bi-directional tip is configured to direct the opening away from the central longitudinal axis in a fourth direction opposite the third direction relative to the central longitudinal axis.
18 . The orienting device of claim 16 , wherein the orienting element is self-biased towards the collapsed delivery configuration.
19 . The orienting device of claim 16 , wherein a distal section of the inner tubular layer includes a plurality of cutouts oriented perpendicular to the central longitudinal axis.
20 . The orienting device of claim 19 , wherein the plurality of cutouts comprises a first plurality of cutouts disposed along a first side of the inner tubular layer and a second plurality of cutouts disposed along a second side of the inner tubular layer opposite the first side;
wherein the first plurality of cutouts is separated from the second plurality of cutouts by opposing longitudinally extending spines oriented parallel to the first plane.