U.S. patent application number 13/656061 was filed with the patent office on 2013-04-25 for devices and methods for stenting an airway.
This patent application is currently assigned to MERIT MEDICAL SYSTEMS, INC.. The applicant listed for this patent is Zeke Eller, William Krimsky. Invention is credited to Zeke Eller, William Krimsky.
Application Number | 20130103163 13/656061 |
Document ID | / |
Family ID | 48136617 |
Filed Date | 2013-04-25 |
United States Patent
Application |
20130103163 |
Kind Code |
A1 |
Krimsky; William ; et
al. |
April 25, 2013 |
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.
Inventors: |
Krimsky; William; (Owings
Mills, MD) ; Eller; Zeke; (Dallas, TX) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Krimsky; William
Eller; Zeke |
Owings Mills
Dallas |
MD
TX |
US
US |
|
|
Assignee: |
MERIT MEDICAL SYSTEMS, INC.
South Jordan
UT
|
Family ID: |
48136617 |
Appl. No.: |
13/656061 |
Filed: |
October 19, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61549874 |
Oct 21, 2011 |
|
|
|
Current U.S.
Class: |
623/23.65 |
Current CPC
Class: |
A61F 2/915 20130101;
A61F 2250/0039 20130101; A61F 2/04 20130101; A61F 2230/0067
20130101; A61F 2/95 20130101; A61F 2/90 20130101; A61F 2230/0069
20130101; A61F 2002/043 20130101 |
Class at
Publication: |
623/23.65 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
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; 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.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit under 35 U.S.C.
.sctn.119(e) of U.S. Provisional Patent Application No. 61/549,874,
entitled "CARINAL STENT," filed Oct. 21, 2011, which is hereby
incorporated herein by reference in its entirety.
TECHNICAL FIELD
[0002] The present disclosure relates generally to devices
configured to be implanted within a body lumen. More particularly,
the present disclosure relates to stents or similar prosthetic
devices which, in certain embodiments, are configured to be
disposed within an airway lumen, specifically, at a bifurcation of
the airway lumen.
BRIEF DESCRIPTION OF THE DRAWINGS
[0003] The written disclosure herein describes illustrative
embodiments that are non-limiting and non-exhaustive. Reference is
made to certain of such illustrative embodiments that are depicted
in the figures, in which:
[0004] FIG. 1 is a diagram of the human lungs and principle parts
of the airway.
[0005] FIG. 2 is a cross-sectional view of the trachea looking
distally to the carina and the right principal bronchus and the
main left bronchus.
[0006] FIG. 3A is a side elevation view of an airway stent,
according to one embodiment of the present disclosure that may be
positioned at the main bifurcation junction of the airway, at or
near the carinal region of the trachea.
[0007] FIG. 3B is a perspective view of the airway stent of FIG.
3A.
[0008] FIG. 3C is a cross-sectional distal-facing view of the
airway stent of FIG. 3A.
[0009] FIG. 3D is a cross-sectional proximal-facing view of the
airway stent of FIG. 3A.
[0010] FIG. 3E is another cross-sectional proximal-facing view of
the airway stent of FIG. 3A.
[0011] FIG. 3F is another perspective view of the airway stent of
FIG. 3A.
[0012] FIG. 4A is a partial sectional view of the human lungs with
the airway stent of FIGS. 3A-3F positioned at the main bifurcation
junction.
[0013] FIG. 4B is a partial sectional view of the human lungs with
an airway stent, according to one embodiment, positioned at a
bifurcation junction of the left main bronchus.
[0014] FIG. 4C is a partial sectional view of the human lungs with
an airway stent, according to one embodiment, positioned in the
airway at a position distal to the left main bronchus.
[0015] FIG. 5A is a side elevation view of an airway stent,
according to another embodiment of the present disclosure.
[0016] FIG. 5B is a perspective view of the airway stent of FIG.
5A.
[0017] FIG. 5C is another perspective view of the airway stent of
FIG. 5A.
[0018] FIG. 6 is a partial sectional view of the airway stent of
FIGS. 5A-5C positioned in an airway at the main bifurcation
junction.
[0019] FIG. 7A is a side elevation view of an airway stent,
according to another embodiment of the present disclosure.
[0020] FIG. 7B is a perspective view of the airway stent of FIG.
7A.
[0021] FIG. 7C is another perspective view of the airway stent of
FIG. 7A.
[0022] FIG. 8 is a partial sectional view of the airway stent of
FIGS. 7A-7C positioned in an airway at the main bifurcation
junction.
[0023] FIG. 9A is a side elevation view of an airway stent,
according to another embodiment of the present disclosure.
[0024] FIG. 9B is a perspective view of the airway stent of FIG.
9A.
[0025] FIG. 9C is another perspective view of the airway stent of
FIG. 9A.
[0026] FIG. 9D is an end view of the airway stent of FIG. 9A.
[0027] FIG. 10 is a partial sectional view of the airway stent of
FIGS. 9A-9D positioned in an airway at the main bifurcation
junction.
DETAILED DESCRIPTION
[0028] Tracheo-bronchial (or "airway") stenting is more and more
commonly performed to relieve difficult or labored breathing caused
by a variety of conditions, including but not limited to extrinsic
and/or intrinsic compression (e.g., stenosis), disease, and loss of
cartilaginous support. Airway stenting can relieve airway
obstruction caused by strictures, injury, disease, or the like that
may not suitably be resolved by debridement, resection,
reconstruction or the like. Airway stenting can also provide
structural support for an airway structurally damaged through
repairing an obstruction, such as by debridement, resection, or
reconstruction.
[0029] In particular, stents are used in tumor patients, to ensure
that the respiratory tract is kept open when the risk exists that
the trachea may be compressed by a tumor. Stents are also used for
stabilization of the airway in the context of tissue distension
(malacia), or to seal off defects in the tracheal or bronchial
walls (fistulae).
[0030] Because of the anatomic structure, airway stenting can be
extremely difficult when an obstruction or structural failure of
the airway involves the carinal region (the main bifurcation
junction between the openings of the right and left principal
bronchi) or another, more distal, bifurcation junction where the
airway branches. The anatomy or structure of a bifurcation junction
is not readily supported by a typical cylindrical stent. A
bifurcation junction is not easily stented with a cylindrical stent
because the cylindrical shape can result in partial occlusion of
the branches. Similarly the branches create flaring or expansion of
the airway, allowing instability in the positioning of the stent. A
cylindrical stent can shift within the expanded area of the
bifurcation junction and migrate down one of the branches, thereby
partially or entirely occluding the other branch.
[0031] Though many of the examples provided herein refer to stents
configured for use within the airway, the present disclosure is
also applicable to a variety of stents designed for a variety of
applications in various lumens of the body.
[0032] It will be readily understood with the aid of the present
disclosure that the components of the embodiments, as generally
described and illustrated in the figures herein, could be arranged
and designed in a variety of configurations. Thus, the following
more detailed description of various embodiments, as represented in
the figures, is not intended to limit the scope of the disclosure,
but is merely representative of various embodiments. While the
various aspects of the embodiments are presented in drawings, the
drawings are not necessarily drawn to scale unless specifically
indicated.
[0033] The phrases "connected to," "coupled to," and "in
communication with" refer to any form of interaction between two or
more entities, including but not limited to mechanical, electrical,
magnetic, electromagnetic, fluid, and thermal interaction. Two
components may be coupled to each other even though they are not in
direct contact with each other. For example, two components may be
coupled to each other through an intermediate component.
[0034] The terms "proximal" and "distal" refer to opposite ends of
a medical device, including the implantable devices disclosed
herein. As used herein, the proximal end of a medical device is the
end nearest a practitioner during use, while the distal end is the
opposite end. For example, the proximal end of a stent refers to
the end nearest the practitioner when the stent is disposed within,
or being deployed from, a deployment apparatus. For consistency
throughout, these terms remain constant in the case of a deployed
stent, regardless of the orientation of the stent within the body.
In the case of an airway stent--deployed through the mouth of a
patient--the proximal end will be nearer the head of the patient
and the distal end nearer the abdomen (or deeper into the lungs)
when the stent is in a deployed position.
[0035] FIG. 1 is a diagram of the human lungs 100. The trachea 102
branches into the right principal bronchus 104 and the left
principal bronchus 106. The bronchus 104, 106 in turn branch into
bronchi 108, which in turn branch into bronchioles 110 and
terminate at alveoli 112. The carina 114 of the trachea 102 is a
cartilaginous ridge that runs anteroposteriorly at a first and main
bifurcation junction 103 of the airway between the right principal
bronchus 104 and the left principal bronchus 106. More distal
(i.e., deeper into the lungs) bifurcation junctions, such as a
bifurcation 105 of the right principal bronchus 104 (or right
bronchus bifurcation junction 105) and the bifurcation 107 of the
left principal bronchus 106 (or left bronchus bifurcation junction
107), may also include a cartilaginous ridge-like structure that is
similar to the carina 114. FIG. 2 is a cross-sectional view of the
main bifurcation junction 103, looking down the trachea 102 (i.e.,
distally, or deeper into the lungs) at the carina 114 and the right
principal bronchus 104 and the left principal bronchus 106. The
bronch.+-.108 of the right principal bronchus 104 are also
illustrated.
[0036] Traditionally a Y-shaped stent has been used in bifurcation
junctions of the airway. A Y-shaped stent can be inadequate
because, among other things, it may not conform to the anatomy of
the patient. For example, the angles of the branches of the stent
may differ from the angles of the principal bronchi 104, 106 or
other more distal airway branches. Also, the diameter of the
branches of the stent may be smaller than the diameter of the
respective airway branches. The greater the differences of the
stent from the anatomy of the patient, the greater the chance for
discomfort or even pain (e.g., the branches of the stent applying
pressure to the sidewall of the bronchi or altering the positioning
of the bronchi) and for partial or complete obstruction of the
airway (e.g., a stent with a diameter that may be too small will
unavoidably function as an obstruction of at least a portion of the
airway and reduce airflow). The present disclosure provides novel
systems and methods for stenting bifurcation junctions of the
airway, including the main bifurcation junction 103, the bronchus
bifurcation junctions 105, 107, and more distal bifurcation
junctions such as bifurcation junctions of the bronchi 108 and/or
bronchioles 110.
[0037] Embodiments may be best understood by reference to the
drawings, wherein like parts are designated by like numerals
throughout. It will be readily understood that the components of
the present disclosure, as generally described and illustrated in
the drawings herein, could be arranged and designed in a wide
variety of different configurations. Thus, the following more
detailed description of the embodiments of the apparatus is not
intended to limit the scope of the disclosure, but is merely
representative of possible embodiments of the disclosure. In some
cases, well-known structures, materials, or operations are not
shown or described in detail.
[0038] FIGS. 3A-3F are an airway stent 300 according to one
embodiment of the present disclosure. FIG. 3A is a side elevation
view of the airway stent 300, providing an anteroposterior view of
the airway stent 300. FIG. 3B is a perspective view of the airway
stent 300. FIG. 3C is a cross-sectional distal-facing view of the
airway stent 300. FIG. 3D is a cross-sectional proximal-facing view
of the airway stent 300. FIG. 3E is another cross-sectional
proximal-facing view of the airway stent 300. FIG. 3F is another
perspective view of the airway stent 300.
[0039] The airway stent 300 may be an implantable device configured
for placement in a lumen of an airway to treat, for example, a
stricture, closure, blockage or occlusion of the airway. The airway
stent 300 may be configured to resist stricture and otherwise
function to maintain patency of the airway. Additionally, the stent
300 may comprise a variety of components, and the parameters of
these components (e.g., shape, length, thickness, position, etc.)
may be configured to provide the stent 300 with certain properties.
For example, the stent 300 may be configured to distribute
transverse loads or to change shape in response to certain
forces.
[0040] Referring collectively to FIGS. 3A-3F, the airway stent 300
may be formed of a suitable material configured in a scaffolding
structure 301 (only partially depicted for simplicity) or mesh and
formed into a tube having a substantially cylindrical shape
(although one or more cross-sectional diameters of the tube may
vary independently as will be described below). The scaffolding
structure 301 may be constructed of a memory material, such as
Nitinol.RTM., including ASTM F2063.
[0041] The thickness of the scaffolding structure 301 may be
between about 0.30 mm and about 0.60 mm. In other embodiments, the
thickness of the scaffolding structure 301 may be between about
0.35 mm and about 0.55 mm. In other embodiments, the thickness of
the scaffolding structure 301 may be between about 0.40 mm and
about 0.50 mm. In other embodiments, the thickness of the
scaffolding structure 301 may be about 0.45 mm.
[0042] As illustrated best in FIG. 3A, the scaffolding structure
301 may be formed of multiple annular segments 322 (or rings)
disposed on a circumference and defining at least a portion of the
generally cylindrical shape of the scaffolding structure 301. Each
annular segment 322 may comprise a plurality of interconnected
strut arms 324. For example, the strut arms 324 may be connected
such that they form a zigzag pattern, defining alternating "peaks"
and "valleys," around the annular segment 322. (As used herein,
"peaks" refer to the relative high points and "valleys" refer to
the relative low points where strut arms 324 arranged in a zigzag
pattern connect. In other words, the peaks and valleys may be
relative to one end 306, 308 of the stent 300, rather than relative
to the circumference of the stent 300.) In some embodiments
adjacent strut arms 324 may form acute angles relative to each
other.
[0043] The adjacent annular segments 322 may be arranged in rows
around a longitudinal axis A.sub.L of the generally cylindrical
shape of the scaffolding structure 301. The rows may be arranged in
the longitudinal direction of the generally cylindrical shape of
the scaffolding structure 301. Adjacent annular segments 322 may be
coupled to each other by connectors 326.
[0044] The components and elements of the scaffolding structure
301, including the annular segments 322, the strut arms 324, and
the connectors 326, may be configured to balance transverse forces
applied to the scaffolding structure 301, for example, to reduce
the incidence of infolding. The components and elements of the
scaffolding structure 301 may be configured to allow at least a
portion of the scaffolding structure 301 to decrease in diameter in
response to an axial force applied to the scaffolding structure
301, for example to enable sheathing of the stent 300 in a
deployment device and/or retrieval of the stent 300.
[0045] Some example embodiments of a scaffolding structure 301 are
disclosed in U.S. patent application Ser. No. 10/288,615 (issued as
U.S. Pat. No. 7,527,644) and U.S. patent application Ser. No.
13/285,358, which are hereby incorporated herein by reference in
their entirety.
[0046] In the figures, only portions of the scaffolding structure
301 are shown, for simplicity. As will be appreciated, the entire
stent 300 may be defined by an integrally formed scaffolding
structure 301. In other embodiments, the scaffolding structure 301
may form merely a portion of the stent 300, such as all or a
portion of a proximal region 302 (or a mid-body) and/or all or a
portion of a distal region 304 (or a flared region), and other
portions of the stent 300 may be formed by another structure and/or
material, such a woven Nitinol wire mesh that may be coupled to the
laser cut scaffolding structure 301 through a winding or weaving
process.
[0047] The scaffolding structure 301 may be coated, or otherwise be
enclosed in a cover 340 formed of a flexible material. The cover
340 may be elastomeric, polymeric, or comprised of any other
material known in the art. In some embodiments, the cover 340 may
include polyurethane, while in certain embodiments the cover may be
comprised only of polyurethane. In some embodiments, the cover 340
may include silicone, while in certain embodiments the cover may be
comprised only of silicone. In some embodiments, an internal
surface of the cover may be coated with a hydrophilic layer. Some
example embodiments of coverings are disclosed in U.S. patent
application Ser. No. 10/669,450 (issued as U.S. Pat. No.
7,637,942), U.S. patent application Ser. No, 10/718,217 (issued as
U.S. Pat. No. 7,959,671), and U.S. patent application Ser. No.
12/616,455 (issued as U.S. Pat. No. 8,206,436), all of which are
hereby incorporated herein by reference in their entirety.
[0048] The airway stent 300 may comprise a proximal region 302 (or
a mid-body) and a distal region 304 (or a flared region). The
distal region 304 may be at a distal end 308 of the proximal region
302. A non-bifurcated single lumen 330 extends axially through the
stent 300 along a longitudinal axis A.sub.L of the stent 300. The
airway stent 300 is configured such that a proximal end 306 of the
proximal region 302 can be positioned in a portion of the airway
and a distal end 308, including the distal region 304, can be
positioned in a bifurcation junction of the airway. For example,
the proximal end 306 may be positioned in the trachea 102 (FIG. 1)
and the distal region 304 can be positioned in the main bifurcation
junction 103 (FIGS. 1 and 2) at the carinal region, as shown, for
example in FIG. 4. The airway stent 300 may have an anterior side
310, a posterior side 312, a left side 314, and a right side 316
(see FIG. 3C). In some embodiments, the airway stent 300 may have a
specific orientation when disposed in the airway. In other words,
the airway stent 300 may only fit in the target bifurcation
junction oriented a certain way.
[0049] The proximal region 302 may have a hollow substantially
cylindrical shape. Particularly at or near the proximal end 306,
the shape of the proximal region 302 may be substantially
cylindrical. The proximal region 302 may be hollow to define a
portion of a lumen 330 through the stent 300. The lumen 330 may
extend axially along a longitudinal axis A.sub.L of both the
cylindrical shape of the proximal region 302 and the stent 300 from
a first opening 332 at the proximal end 306 of the stent 300 to a
second opening 334 at the distal end 308 of the stent 300. A
cross-section of the proximal region 302 may be substantially
circular, particularly at the proximal end 306. The circular
cross-section of the proximal region 302 is shown in FIG. 3D. The
first opening 332 may be circular. A transverse cross-section of
the proximal region 302 and the lumen 330 at a distal end of the
proximal region 302 may be circular or approximately circular.
Described differently, a diameter D1 of the proximal region 302
extending from the anterior side 310 to the posterior side 312 (an
anteroposterior diameter) may be substantially the same as a
diameter D2 of the proximal region 302 extending from the left side
314 to the right side 316 (a lateral diameter). For example, in one
embodiment, the airway stent 300 may be designed and configured for
placement in the trachea 102 (see FIG. 1) and may have a
cross-sectional diameter D1, D2 of the proximal region 302 that is
between approximately fourteen millimeters and twenty-two
millimeters. In another embodiment, the airway stent 300 may be
designed and configured for placement in a bronchial portion of the
airway (e.g., in the bronchi 108 shown in FIG. 1). An airway stent
300 configured for placement in the left main bronchus 106, the
cross-sectional diameter D1, D2 of the proximal region 302 may
between approximately six millimeters and sixteen millimeters. As
can be appreciated, in an airway stent 300 configured for placement
in the bronchioles, the diameter D1, D2 of the proximal region 302
may be smaller.
[0050] In other embodiments, the cross-sectional shape of the
proximal region 302 and/or the lumen 330 may vary along the length
L1 of the stent 300, for example to conform to the shape and/or
features of the airway.
The length L1 of the proximal region 302 can vary as appropriate to
provide desired stenting support and/or to conform to patient
anatomy. For example, an airway stent 300 configured for placement
in the trachea 102, to stent the main bifurcation junction 103 (see
FIGS. 1 and 2), may have a proximal region 302 with a length L1
that is between approximately thirty millimeters and ninety
millimeters. An airway stent 300 configured for placement in a
bronchial portion of the airway (e.g., in the bronch.+-.108 of
FIGS. 1 and 2) may have a proximal region 302 with a length L1 that
is between approximately fifteen millimeters and fifty millimeters.
As can be appreciated, in an airway stent 300 configured for
placement in the bronchioles, the length L1 of the proximal region
302 may be smaller.
[0051] The distal region 304 is positioned at the distal end 308 of
the stent 300 and/or the proximal region 302. A proximal end of the
distal region 304 couples to and conforms to a circumference of a
distal end of the proximal region 302. The distal region 304 may be
configured to flare distally and outwardly to substantially conform
to the anatomy of a bifurcation junction. The distal region 304 may
define a distal portion of the lumen 330 through the stent 300 and
a second opening 334 into the lumen 330. An airway bifurcation
junction, such as the main bifurcation junction 103 near the
carinal region, naturally flares. However, the anteroposterior
diameter of the airway in a bifurcation junction may not flare to
the same degree as the lateral diameter of the airway. The lateral
diameter may typically flare to a greater degree than the
anteroposterior diameter. Accordingly, a cross-section of the
distal region 304 of the stent 300 may have a substantially
elliptical shape, having a greater lateral diameter D2 than an
anteroposterior diameter D1, as shown in FIGS. 3C and 3E. (The
anteroposterior diameter D1 and the lateral diameter D2 may be
transverse to and may intersect the longitudinal axis A.sub.L of
the stent 300 and may also be referred to herein as first and
second diameters, respectively.) For example, an airway stent 300
configured for placement in the trachea 102, to stent the main
bifurcation junction 103 (see FIGS. 1 and 2), may have a distal
region 304 with an anteroposterior diameter D1 at the edge 320 of
the distal region 304 that is between approximately fourteen
millimeters and twenty-two millimeters and a lateral diameter D2 at
the edge 320 of the distal region 304 that is between approximately
nineteen millimeters and thirty-two millimeters. An airway stent
300 configured for placement in a bronchial portion of the airway
(e.g., in the bronchi 108) may have a distal region 304 with an
anteroposterior diameter D1 at the edge 320 of the distal region
304 that is between approximately six millimeters and sixteen
millimeters and a lateral diameter D2 that is between approximately
twelve millimeters and twenty-eight millimeters. As can be
appreciated, in an airway stent 300 configured for placement in the
bronchioles, the diameter D1, D2 of the distal region 302 may be
smaller.
[0052] The degree or angle at which the anteroposterior diameter D1
and the lateral diameter D2 may flare can vary. Differing degrees
of flaring are possible, and can be configured independently as
desired according to the anatomy of a patient. Stated differently,
an angle A1 at which the distal region 304 flares anteroposteriorly
can vary independently from the angle A2 at which the distal region
304 flares laterally.
[0053] A length L2 of the distal region 304 can vary, for example,
to provide desired stenting support and according to patient
anatomy. As an example, an airway stent 300 configured for
placement in the trachea 102, to stent the main bifurcation
junction 103 (see FIGS. 1 and 2), may have a distal region 304 with
a length L2 that is between approximately five millimeters and
fifteen millimeters. An airway stent 300 configured for placement
in a bronchial portion of the airway (e.g., in the bronchi 108) may
have a distal region 304 with a length L2 that is between
approximately two millimeters and ten millimeters. As can be
appreciated, in an airway stent 300 configured for placement in the
bronchioles, the length L2 of the distal region 304 may be
smaller.
[0054] In the FIGS. 3A, 3B, and 3F, the airway stent 300 is
depicted as having an abrupt transition from the proximal region
302 to the distal region 304. However, as can be appreciated, in
other embodiments the transition from the proximal region 302 to
the distal region 304 may be gradual. In some embodiments, the
transition may be imperceptible. The proximal region 302 may simply
gradually flare distally. Moreover, the transition from a circular
cross-section of the proximal region 302 to an elliptical
cross-section of the distal region 304 may be gradual and nearly
imperceptible.
[0055] In the illustrated embodiment of FIGS. 3A-3F, the distal
edge 320 of the distal region 304 may be configured to have a
planar configuration, meaning that the distal edge 320 may appear
substantially flush or planar (for example, relative to a plane
orthogonal to the longitudinal axis of the stent) when viewing the
stent 300 from the side, such as anteroposteriorly or laterally. As
appreciated, other configurations are possible, as will be
described below with reference to FIGS. 5A-5C and 7A-7C.
[0056] The flare of the distal region 304 and/or the elliptical
shape of the distal edge 320 may serve as anti-migration features
to secure the stent 300 from proximal (toward the mouth) and/or
distal migration (down deeper into the airway). The stent 300, and
in particular the scaffolding structure 301, may include additional
anti-migration features. For example, one or more strut arms 324
may be slightly raised above (outward from) an outer circumference
of the scaffolding structure 301.
[0057] FIG. 4 is a cross-sectional view of the human lungs 100 and
a sectional view of the airway stent 300 of FIGS. 3A-3F positioned
in the airway to stent the trachea 102 near the carinal region
and/or the main bifurcation junction 103. The main body 302 of the
stent 300 is disposed within the trachea 102 and the distal region
304 flares and opens into the main bifurcation junction 103. The
distal region 304 is disposed in the main bifurcation junction 103
above (proximal to) the carina 114 and between the right bronchus
104 and the left bronchus 106.
[0058] Presently available airway stents are delivered or deployed
using a rigid bronchoscope. The rigidity, size, shape, and/or
configuration of a bronchoscope prevent deployment of presently
available airway stents deeper than the main bifurcation junction
(or the tracheal bifurcation junction) at the carina 114. Moreover,
presently available stents for stenting a bifurcation junction are
Y-shaped (with a bifurcated lumen) and must be deployed by a rigid
bronchoscope, and thus cannot be deployed distal to the carina 114
and/or the bronchi 104, 106. By contrast, the disclosed embodiments
may be configured to be deployed with a deployment mechanism that
can be guided over a guide wire. Accordingly, the embodiments of
the present disclosure can be deployed almost anywhere a guide wire
can be positioned within the lungs, including bifurcation junctions
of the main bronchi 104, 106 and/or bifurcation junctions distal to
the main bronchi 104, 106.
[0059] FIG. 4B is a sectional view of the human lungs 100 with an
airway stent 300b positioned at left bronchus bifurcation junction
107 at a distal end of the left main bronchus 106. In FIG. 4B,
guide wire 402 is shown, which may be used in positioning and/or
guiding a tubular member 404 of a deployment apparatus into the
airway to a desired target location. The tubular member 404 is
illustrated in FIG. 4B advanced down the trachea 102 over a portion
of the guide wire 402. A flared portion of the stent 300b is
positioned in the bifurcation junction where the left main bronchus
106 branches into secondary bronchi 108. The stent 300b is
positioned proximal to the bronchioles 110.
[0060] FIG. 4C is a sectional view of the human lungs 100 with an
airway stent 300c positioned at a location distal to the left main
bronchus 106. More specifically, the airway stent 300c is deployed
within a branch of the airway at a bifurcation junction 412 that is
distal to the left bronchus bifurcation junction 107 located at a
distal end of the left principal bronchus 106 of the airway. The
airway stent 300c may be deployed within bronchi 108 and/or
bronchioles 110 that branch into bronchioles 110. As noted above,
the embodiments of the present disclosure can be deployed almost
anywhere a guide wire can be positioned within the lungs, including
bifurcation junctions relatively deep within the airway and far
distal to the main bronchi 104, 106 and the main bifurcation
junction 103.
[0061] FIGS. 5A-5C illustrate an airway stent 500, according to
another embodiment of the present disclosure. The airway stent 500
may include a distal region 504 with a convex configuration,
meaning that the distal edge 520 of the distal region 504 may
appear convex when viewed anteroposteriorly from the side. FIG. 5A
is a side elevation view of the airway stent 500 viewed
anteroposteriorly. FIG. 5B is a perspective view of the airway
stent 500 of FIG. 5A. FIG. 5C is another perspective view of the
airway stent 500 of FIG. 5A.
[0062] The stent 500 of FIGS. 5A-5C may resemble the stent 300
described above with respect to FIGS. 3A-3F. Accordingly, like
features may be designated with like reference numerals, with the
leading digits incremented to "5." Relevant disclosure set forth
above regarding similarly identified features thus may not be
repeated hereafter. Moreover, specific features of the stent 500
may not be shown or identified by a reference numeral in the
drawings or specifically discussed in the written description that
follows. However, such features may clearly be the same, or
substantially the same, as features depicted in other embodiments
and/or described with respect to such embodiments. Accordingly, the
relevant descriptions of such features apply equally to the
features of the stent 500. Any suitable combination of the features
and variations of the same described with respect to the stent 300
can be employed with the stent 500, and vice versa. This pattern of
disclosure applies equally to further embodiments depicted in
subsequent figures and described hereafter.
[0063] Referring collectively to FIGS. 5A-5C, the airway stent 500
includes a proximal region 502 (or a mid-body) and a distal region
504 (or a flared region). A non-bifurcated single lumen 530 may be
defined through the airway stent 500. The airway stent 500 may be
formed of a suitable material configured in a scaffolding structure
501 (only partially depicted for simplicity). The scaffolding
structure 501 may form or define at least a portion of the mid body
502 and/or the distal region 504. The scaffolding structure 501 may
form a hollow, substantially cylindrical shaped tube (although one
or more cross-sectional diameters of the tube may vary
independently as will be described below). The scaffolding
structure 501 may be constructed of a memory material, such as
Nitinol.RTM., including ASTM F2063.
[0064] As illustrated in FIGS. 5A-5C, the scaffolding structure 501
may be formed of multiple annular segments, similar to the annular
segments 322 of the stent 300 shown in FIGS. 3A-3F and described
above with respect to the same. However, the scaffolding structure
501 may include annular segments that may be interconnected to one
or more adjacent annular segments by a plurality of connectors, or
otherwise directly interconnect, to form diamond-shaped cells.
[0065] As mentioned above, the distal region 504 of the airway
stent 500 may have a convex configuration. The airway stent 500
having the distal region 504 in a convex configuration may be
positioned in a bifurcation junction of an airway differently than
an airway stent having a planar configuration, such as the stent
300 of FIGS. 3A-3F and 4. In particular, than the left side 514 and
right side 516 of the distal edge 520 of airway stent 500 may sit
more proximal (or higher, with less depth) in the airway than the
corresponding left side 314 and right side 316 of the distal edge
320 of airway stent 300, which has a planar configuration.
[0066] The left side 514 and right side 516 of the distal region
504 of the airway stent 500 may form and/or comprise lateral
support regions. The depth of these lateral support regions within
the airway may be dependent on the concavity or convexity of the
distal region 504. When a tumor is positioned substantially down a
branch of a bifurcation junction, for example on a wall opposite
the carina 114 (or analogous ridge-like structure of another
bifurcation junction), positioning the lateral support regions more
distal may be desirable. In other words, an airway stent having a
planar configuration, such as the airway stent 300 of FIGS. 3A-3F
and 4, or an airway stent having a convex configuration, such as
the airway stent 700 of FIGS. 7A-7C and 8, which is described more
fully below, may better perform a desired stenting function or
treatment.
[0067] By contrast, the anatomy of a patient may be such that the
branches of a target bifurcation junction (i.e., the bifurcation
junction to be stented) may branch at a relatively high angle. As a
result, the branches may be partially occluded by lateral support
regions positioned too deeply in the target bifurcation junction.
Accordingly, a convex configuration may be desirable to maintain or
preserve patency of the airway.
[0068] FIG. 6 is a partial sectional view of the airway stent of
FIGS. 5A-5C positioned in an airway to stent the trachea 102 at or
near the carinal region and/or the main bifurcation junction 103.
The main body 502 of the stent 500 is disposed within the trachea
102 and the distal region 504 flares and opens into the main
bifurcation junction 103. As illustrated in FIG. 6, the left and
right sides 514, 516, or lateral support regions, of the distal
region 504 are positioned high against an upper surface of the main
bifurcation junction 103, thereby avoiding occlusion of the right
and left bronchi 104, 106. The distal region 504 is disposed in the
main bifurcation junction 103 above (proximal to) the carina 114
and between the right bronchus 104 and the left bronchus 106.
[0069] As can be appreciated, a variety of configurations of the
distal region are possible to provide varying lateral support while
avoiding unnecessary occlusion of the branches of a bifurcation
junction of an airway.
[0070] FIGS. 7A-7C illustrate an airway stent 700, according to
another embodiment of the present disclosure. The airway stent 700
may include a distal region 704 with a concave configuration,
meaning that the distal edge 720 of the distal region 704 may
appear convex when viewed anteroposteriorly from the side. FIG. 7A
is a side elevation view of the airway stent 700. FIG. 7B is a
perspective view of the airway stent of FIG. 7A. FIG. 7C is another
perspective view of the airway stent of FIG. 7A.
[0071] The stent 700 of FIGS. 7A-7C may resemble the stent
embodiments described above. Accordingly, like features may be
designated with like reference numerals, with the leading digits
incremented to "7." Relevant disclosure set forth above regarding
similarly identified features thus may not be repeated hereafter.
Moreover, specific features of the stent 700 may not be shown or
identified by a reference numeral in the drawings or specifically
discussed in the written description that follows. However, such
features may clearly be the same, or substantially the same, as
features depicted in other embodiments and/or described with
respect to such embodiments. Accordingly, the relevant descriptions
of such features apply equally to the features of the stent 700.
Any suitable combination of the features and variations of the same
described with respect to the previously disclosed stents can be
employed with the stent 700, and vice versa. This pattern of
disclosure applies equally to further embodiments depicted in
subsequent figures and described hereafter.
[0072] Referring collectively to FIGS. 7A-7C, the airway stent 700
includes a proximal region 702 (or a mid-body) and a distal region
704 (or a flared region). A non-bifurcated single lumen 730 may be
defined through the airway stent 700. The airway stent 700 may be
formed of a suitable material configured in a scaffolding structure
701 (only partially depicted for simplicity). The scaffolding
structure 701 may form or define at least a portion of the mid body
702 and/or the distal region 704. The scaffolding structure 701 may
form a hollow, substantially cylindrical shaped tube (although one
or more cross-sectional diameters of the tube may vary
independently as will be described below). The scaffolding
structure 701 may be constructed of a memory material, such as
Nitinol.RTM., including ASTM F2063.
[0073] As illustrated in FIGS. 7A-7C, the scaffolding structure 701
may be formed of multiple annular segments, similar to the annular
segments 322 of the stent 300 shown in FIGS. 3A-3F and described
above with respect to the same. However, the scaffolding structure
701 may include annular segments that may be configured to
interconnect to one or more adjacent annular segments by a
plurality of connectors, or otherwise directly interconnect in a
helical pattern.
[0074] The scaffolding structure 701 may comprise one or more rows
of strut arms (e.g., annular segments) arranged and interconnected
in a series of turns to form a helix or helical pattern that wraps
or winds around the longitudinal axis A.sub.L of the stent 700. The
helical pattern of strut arms may be disposed on a circumference
and may define at least a portion of the generally cylindrical
shape of the scaffolding structure 301. As can be appreciated, in
some embodiments, the entire length of the stent 300 may comprise a
helical pattern of interconnected strut arms. In other embodiments,
however, only a portion of the stent 700, for example, a proximal
zone or a transition zone, may comprise a helical pattern. The
helical pattern may be right-handed or left-handed depending on
which direction the one or more rows of strut arms wrap around the
longitudinal axis A.sub.L.
[0075] The helical pattern may comprise a row of strut arms
arranged to form a zigzag pattern, defining alternating "peaks" and
"valleys," that may wrap around the longitudinal axis A.sub.L of
the stent 700. In some embodiments, the "peaks" and "valleys" on a
row of strut arms may be coupled by connectors. In particular, the
"peaks" on one turn of the helical pattern may be coupled to the
"valleys" on an adjacent turn of the helical pattern via
connectors. As used herein, a "turn" of the helical pattern refers
to a segment of strut arms that wraps 360 degrees around the
longitudinal axis A.sub.L of the stent 700. Adjacent turns of the
helical pattern may adjoin each other at an end.
[0076] The helical pattern may wrap around the longitudinal axis
A.sub.L of the stent 700 at an angle. The angle may vary and may
affect the structural properties of the stent 700. In some
embodiments, the angle may remain substantially constant throughout
the helical pattern. In other embodiments, however, the angle may
vary throughout the helical pattern.
[0077] As mentioned above, the distal region 704 of the airway
stent 700 may have a concave configuration. The airway stent 700
having the distal region 704 in a concave configuration may be
positioned in a bifurcation junction of an airway differently than
an airway stent having a planar configuration, such as the stent
300 of FIGS. 3A-3F and 4, and differently than an airway stent
having a convex configuration, such as the stent 500 of FIGS. 5A-5C
and 6. In particular, the lateral sides (e.g., the left side 714
and right side 716) of the distal edge 720 of the airway stent 700
may sit more distal in the airway than the corresponding lateral
sides (e.g., left side 314, 514 and right side 316, 516) of the
distal edge 720 of the airway stent 700.
[0078] The left side 714 and right side 716 of the distal region
704 of the airway stent 500 may form and/or comprise lateral
support regions. The depth of these lateral support regions within
the airway may be dependent on the concavity or convexity of the
distal edge of the distal region 704. When a tumor or other
occlusion is positioned substantially down a branch of a
bifurcation junction, for example on a wall opposite the carina 114
(or an analogous ridge-like structure of another target bifurcation
junction), positioning the lateral support regions more distal may
be desired. An airway stent having a concave configuration may
better perform a desired stenting function or treatment on more
distal occlusions.
[0079] FIG. 8 is a partial sectional view of the airway stent of
FIGS. 7A-7C positioned in an airway to stent the trachea 102 at or
near the carinal region and/or the main bifurcation junction 103.
The main body 702 of the stent 700 is disposed within the trachea
102. The distal region 704 is disposed in the main bifurcation
junction 103 above (proximal to) the carina 114 and between the
right bronchus 104 and the left bronchus 106. The distal region 704
flares and opens into the main bifurcation junction 103. As
illustrated in FIG. 8, the left and right sides 714, 716, or
lateral support regions, of the distal region 704 are positioned to
extend deeper into the airway against an upper surface of the main
bifurcation junction 103, thereby providing stenting support at a
greater depth into the right and left bronchi 104, 106.
[0080] As can be appreciated, a variety of configurations of the
distal region 704 are possible to provide varying lateral support
while avoiding unnecessary occlusion of the branches of a
bifurcation junction of an airway.
[0081] A variety of configurations of the distal region 704 are
possible to provide varying lateral support for an occlusion that
is deeper into a bifurcation junction of an airway. For example,
the lateral support regions may further include projections (or
wing-like structures) that extend further distally down the airway
and provide more distal stenting support.
[0082] FIGS. 9A-9D illustrate an airway stent 900, according to
another embodiment of the present disclosure. FIG. 9A is a side
elevation view of the airway stent 900. FIG. 9B is a perspective
view of the airway stent 900 of FIG. 9A. FIG. 9C is another
perspective view of the airway stent 900 of FIG. 9A. FIG. 9C is an
end view of the airway stent 900 of FIG. 9A.
[0083] The stent 900 of FIGS. 9A-9D may resemble the stent
embodiments described above. Accordingly, like features may be
designated with like reference numerals, with the leading digits
incremented to "9." Relevant disclosure set forth above regarding
similarly identified features thus may not be repeated hereafter.
Moreover, specific features of the stent 900 may not be shown or
identified by a reference numeral in the drawings or specifically
discussed in the written description that follows. However, such
features may clearly be the same, or substantially the same, as
features depicted in other embodiments and/or described with
respect to such embodiments. Accordingly, the relevant descriptions
of such features apply equally to the features of the stent 900.
Any suitable combination of the features and variations of the same
described with respect to the previously disclosed stents can be
employed with the stent 900, and vice versa. This pattern of
disclosure applies equally to further embodiments depicted in
subsequent figures and described hereafter.
[0084] Referring collectively to FIGS. 9A-9D, the airway stent 900
may include a proximal region 902 (or a mid-body) and a distal
region 904 (or a flared region). A non-bifurcated single lumen 930
may be defined through the airway stent 900. The distal region 904
of the airway stent 900 may include a pair of notches 917 in the
distal edge 920 that may be configured to engage, for example, the
carina 114 (see FIG. 10) of the main bifurcation junction 103 of
the trachea 102 or analogous cartilaginous ridge in a more distal
bifurcation junction of the airway.
[0085] The notches 917 may be positioned opposite each other on the
anterior side 910 and posterior side 912 of the distal region 904,
as shown in FIG. 9D. The notches 917 may be substantially aligned
to form an engagement region 918 at the distal edge 920. The
notches 917 and resulting engagement region 918 can provide
stability to the positioning of the airway stent 900 by limiting
shifting of the stent toward the left or right. The notches 917, by
limiting shifting of the stent, reduce a risk that the airway stent
900 may partially occlude the bifurcation junction of the airway.
Moreover, the airway stent 900 is substantially secured in place on
the carina 114 of the main bifurcation junction 103 (see FIG. 10)
or similar cartilaginous ridge of a more distal bifurcation
junction, and is thereby limited from migrating distally down the
airway. Stabilization of the airway stent 900 at or on the carina
114 (or analogous structure) can provide lateral support for flare
region 904 and allow improved stenting expansion to open an
occluded bifurcation junction or provide needed structural support
of a bifurcation junction.
[0086] FIG. 10 is a partial sectional view of the airway stent of
FIGS. 9A-9D positioned in an airway to stent the trachea 102 at or
near the main bifurcation junction 103, which branches in to the
right bronchus 104 and the left bronchus 106. The main body 902 of
the stent 900 is disposed within the trachea 102. The distal region
904 is disposed in the main bifurcation junction 103 above
(proximal to) the carina 114 and between the right bronchus 104 and
the left bronchus 106. The distal region 904 flares and opens into
the main bifurcation junction 103. The notches 917 of the distal
region 904 are shown engaging the cartilaginous ridge of the
bifurcation junction, which in FIG. 10 is the carina 114 in the
main bifurcation junction 103.
[0087] In another embodiment of an airway stent, a proximal end of
the proximal portion may include a flared region. The flared region
may be substantially symmetrical. In one embodiment, the flared
region at the proximal end may have a diameter that is between one
millimeter and four millimeters larger than a diameter of the
main-body of the proximal region. The size and degree of the flare
region at the proximal end may depend on whether the airway stent
is configured for placement in the trachea, bronchi, or
bronchioles. The proximal flared region may be a feature of any of
the above disclosed embodiments.
[0088] The embodiments of the present disclosure may include
radiopaque markers at a proximal end and/or a distal stent ends.
The markers on the distal end of the stent may be paired at the
lateral sides and/or the anterior and posterior sides to aid a
practitioner during deployment orientation.
[0089] The proximal end may include suture eyelets and/or a suture
to aid with purse-string and removal from the airway post
deployment.
[0090] The examples and embodiments disclosed herein are to be
construed as merely illustrative and exemplary, and not a
limitation of the scope of the present disclosure in any way. It
will be understood to those having skill in the art that changes
may be made to the details of the above-described embodiments
without departing from the underlying principles of the disclosure
herein. For example, any suitable combination of various
embodiments, or the features thereof, is contemplated. For example,
any of the implantable devices disclosed herein can include a
scaffolding structure of any of the other embodiments (e.g., a
pattern of strut arms and annular segments of any one or more of
the various other disclosed embodiments). As another example, any
of the stents can include a distal edge having any of a planar
configuration, a concave configuration, or a convex configuration.
As another example, any of the stents may include notches in the
distal edge. Furthermore, although symmetries are present in the
illustrated embodiments, some embodiments may be asymmetrical.
[0091] It is intended that the scope of the invention be defined by
the claims appended hereto and their equivalents.
* * * * *