Devices and methods for stenting an airway

Abstract

An implantable device and method are disclosed for stenting an occlusion of an airway. The implantable device includes a cylindrical tube shaped proximal region, a flared distal region, and a non-bifurcated single lumen extending through the device. The proximal region defines a proximal portion of the lumen and the distal region defines a distal portion of the lumen. The distal region may flare outward laterally at a first angle and anteroposterior at a second angle, thereby forming an elliptically shaped distal opening to the lumen. The distal edge of distal opening may lie entirely in a plane orthogonal to a longitudinal axis of the device. Alternatively, the distal edge may be non-planar, such as concave or convex, when viewed in an anteroposterior direction. The implantable device may be formed of a scaffolding structure.

What is claimed is: 
     
         1 . An airway stent, comprising:
 a proximal region having a cylindrical shape with a first opening at a proximal end, the first opening having a diameter equivalent to a diameter of the proximal region of the airway stent;   a distal region extending from the proximal region to a second opening at a distal end, the distal region flaring outward such that the second opening has a transverse cross-section with an elliptical shape having a lateral diameter that is larger than an anteroposterior diameter; and   a non-bifurcated single lumen that extends from the first opening and through the proximal and distal regions to the second opening.   
     
     
         2 . The airway stent of  claim 1 , wherein a transverse cross-section of the non-bifurcated single lumen at a proximal end of the distal region is approximately circular. 
     
     
         3 . The airway stent of  claim 1 , wherein the anteroposterior diameter of the second opening is larger than an anteroposterior diameter of a transverse cross-section of the non-bifurcated single lumen at a proximal end of the distal region. 
     
     
         4 . The airway stent of  claim 1 , wherein the distal region flares outward at a plurality of angles about a circumference of the distal region to conform to an upper surface of an anatomy of a target bifurcation junction of an airway. 
     
     
         5 . The airway stent of  claim 1 , wherein the distal region flares anteroposteriorly at a first angle and flares laterally at a second angle. 
     
     
         6 . The airway stent of  claim 1 , wherein a distal edge of the distal region lies in a plane orthogonal to a longitudinal axis of the non-bifurcated single lumen. 
     
     
         7 . The airway stent of  claim 1 , wherein a distal edge of the distal region is convex as viewed in an anteroposterior direction. 
     
     
         8 . The airway stent of  claim 1 , wherein a distal edge of the distal region is concave as viewed in an anteroposterior direction. 
     
     
         9 . The airway stent of  claim 1 , wherein a distal edge of the distal region includes a first notch at an anterior side and a second notch at a posterior side, wherein the first and second notches are configured to engage a cartilaginous ridge that runs anteroposteriorly between branches of an airway at a target bifurcation junction. 
     
     
         10 . The airway stent of  claim 1 , further comprising a scaffolding structure forming at least a portion of at least one of the proximal region and the distal region and defining a portion of the non-bifurcated single lumen through the airway stent, the scaffolding structure formed of a plurality of annular segments each comprising a plurality of interconnected struts with adjacent struts disposed at angles relative to each other around a circumference of the at least one of the proximal region and the distal region, wherein the plurality of annular segments are arranged in rows in a longitudinal direction of the cylindrical shape. 
     
     
         11 . The airway stent of  claim 10 , further comprising a polymeric cover applied to and between the struts of the plurality of annular segments, the polymeric cover defining an interior region within the scaffolding structure. 
     
     
         12 . The airway stent of  claim 10 , wherein each annular segment of the plurality of annular segments is coupled to an adjacent annular segment. 
     
     
         13 . The airway stent of  claim 12 , wherein the scaffolding structure further comprises a plurality of connectors extending between and interconnecting adjacent annular segments, the connectors arranged in an alternating pattern, such that connectors that are adjacent in the longitudinal direction are offset from each other in a circumferential direction. 
     
     
         14 . An implantable device to stent an airway at a bifurcation junction, the implantable device comprising:
 a proximal region having a cylindrical hollow tube shape defining a proximal portion of a non-bifurcated single lumen through the implantable device, the non-bifurcated single lumen extending axially along a longitudinal axis of the implantable device from a first opening at a proximal end of the implantable device to a second opening at a distal end of the implantable device;   a distal region disposed at and extending from a distal end of the proximal region, the distal region flaring distally and outwardly from the proximal region to the second opening to define a distal portion of the non-bifurcated single lumen through the implantable device and to enlarge one or more diameters of the non-bifurcated single lumen at the second opening at the distal end of the implantable device;   wherein the second opening of the non-bifurcated single lumen of the implantable device, at the distal end of the distal region, has a transverse cross-section with an elliptical shape having a first diameter and a second diameter transverse to the first diameter, the first diameter being larger than the second diameter, larger than a diameter of the first opening at the proximal end of the implantable device, and larger than a diameter of a transverse cross-section of the non-bifurcated single lumen at a proximal end of the distal region and at the distal end of the proximal region.   
     
     
         15 . The implantable device of  claim 14 , wherein the anteroposterior diameter of the distal region is larger than an anteroposterior diameter of a transverse cross-section of the non-bifurcated single lumen at a proximal end of the distal region. 
     
     
         16 . The implantable device of  claim 14 , wherein the distal region flares anteroposteriorly at a first angle and flares laterally at a second angle. 
     
     
         17 . The implantable device of  claim 14 , wherein a distal edge of the distal region lies in a plane orthogonal to the longitudinal axis. 
     
     
         18 . The implantable device of  claim 14 , wherein a distal edge of the distal region does not lie entirely in a plane orthogonal to the longitudinal axis. 
     
     
         19 . The implantable device of  claim 14 , further comprising a scaffolding structure forming at least a portion of at least one of the proximal region and the distal region and defining a portion of the non-bifurcated single lumen through the implantable device, the scaffolding structure formed of a plurality of annular segments each comprising a plurality of interconnected struts with adjacent struts disposed at angles relative to each other around a circumference of the at least a portion of the at least one of the cylindrical shape of the proximal region and the distal region, wherein the plurality of annular segments are arranged in rows in the longitudinal direction of the cylindrical shape. 
     
     
         20 . A method of stenting an airway of a patient at or near a bifurcation junction of a lumen of the airway, the method comprising:
 obtaining an implantable device having a cylindrical shaped proximal region, a distal region disposed at a distal end of the proximal region, and a non-bifurcated single lumen disposed through the implantable device;   positioning a deployment apparatus within the airway at a desired position at or near the bifurcation junction, the deployment apparatus loaded with the implantable device;   deploying the implantable device from the deployment apparatus; and   positioning the distal region of the implantable device within the bifurcation junction of the lumen of the airway.   
     
     
         21 . The method of  claim 20 , wherein a distal opening of the non-bifurcated single lumen of the implantable device, at a distal end of the distal region, has a transverse cross-section with an elliptical shape having a lateral diameter that is larger than an anteroposterior diameter, and wherein the method further comprises:
 orienting the distal region to align the anteroposterior diameter in an anteroposterior direction within bifurcation junction.   
     
     
         22 . The method of  claim 20 , wherein the distal region flares anteroposteriorly at a first angle and flares laterally at a second angle, and wherein the method further comprises:
 orienting the distal region to align the first angle of outward flare of the distal region in an anteroposterior direction within bifurcation junction.   
     
     
         23 . The method of  claim 20 , wherein a distal edge of the distal region of the implantable device comprises a notch, and wherein the method further comprises:
 aligning the notch to engage a cartilaginous ridge of the bifurcation junction that runs anteroposteriorly between branches of the airway at the bifurcation junction.   
     
     
         24 . The method of  claim 23 , wherein the cartilaginous ridge is a carina disposed between a left bronchus and a right bronchus at a main bifurcation junction at a distal end of a trachea, and
 wherein aligning the notch comprises engaging the carina within the main bifurcation junction at a distal end of a trachea.   
     
     
         25 . The method of  claim 20 , wherein the bifurcation junction is disposed distal to one of a right principal bronchus and a left principal bronchus of the airway. 
     
     
         26 . The method of  claim 20 , wherein the bifurcation junction is at a distal end of a branch of the airway that is located distal to a bifurcation junction at a distal end of one of a right principal bronchus and a left principal bronchus of the airway. 
     
     
         27 . The method of  claim 20 , further comprising:
 positioning a guidewire within the airway to a desired position at or near the bifurcation junction, wherein positioning the deployment apparatus within the airway comprises advancing the deployment apparatus, including the implantable device, over the guidewire.