Devices and methods for stenting an airway

• US 9,539,083 B2
• Filed: 11/21/2014
• Issued: 01/10/2017
• Est. Priority Date: 10/21/2011
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Merit Medical Systems, Inc.
• Inventors: Krimsky, William, Eller, Zeke
• Primary Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US14/550,455
• Publication Number:
  US 20150081035A1
• Time in Patent Office: 781 Days
• Field of Search: 623/1.31, 623/23.65
• US Class Current: 1/1
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/043 Bronchi
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0039 differing in diameter

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.

Claims

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, 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; 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, 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.

10. The airway stent of claim 9, 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.

11. The airway stent of claim 9, wherein each annular segment of the plurality of annular segments is coupled to an adjacent annular segment.

12. The airway stent of claim 11, 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.

13. 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 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;

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.

14. The implantable device of claim 13, 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.

15. The implantable device of claim 13, wherein the distal region flares anteroposteriorly at a first angle and flares laterally at a second angle.

16. The implantable device of claim 13, wherein a distal edge of the distal region lies in a plane orthogonal to the longitudinal axis.

17. The implantable device of claim 13, wherein a distal edge of the distal region does not lie entirely in a plane orthogonal to the longitudinal axis.

18. The implantable device of claim 13, 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.