U.S. patent application number 15/300687 was filed with the patent office on 2017-06-22 for anchoring mechanisms and systems for endoluminal devices.
This patent application is currently assigned to Spiration, Inc. d.b.a. Olympus Respiratory America. The applicant listed for this patent is Spiration, Inc. d.b.a. Olympus Respiratory America. Invention is credited to Jean-Martin Baillargeon, David H. Dillard, Timothy J. Johnson, Lisa Lauer, Brandon James Shuman.
Application Number | 20170172722 15/300687 |
Document ID | / |
Family ID | 59523814 |
Filed Date | 2017-06-22 |
United States Patent
Application |
20170172722 |
Kind Code |
A1 |
Dillard; David H. ; et
al. |
June 22, 2017 |
ANCHORING MECHANISMS AND SYSTEMS FOR ENDOLUMINAL DEVICES
Abstract
Devices and methods for occluding airways in at least one
direction are disclosed. In some cases, the devices include
anchoring mechanisms configured to keep an operative portion of the
device (e.g., a valve) in position along a length of a lumen in
which the device is deployed. The anchoring mechanisms can include
anchors configured to settle into the lumen walls with little or no
axial movement of the operative portion of the device. In some
embodiments, the anchoring mechanisms include a secondary set of
anchors configured to engage with the lumen wall to reduce,
inhibit, or prevent axial movement of the operative portion of the
device when the primary anchors settle into the walls of the
lumen.
Inventors: |
Dillard; David H.;
(Grapeview, WA) ; Johnson; Timothy J.; (Kent,
WA) ; Shuman; Brandon James; (Kirkland, WA) ;
Baillargeon; Jean-Martin; (Seattle, WA) ; Lauer;
Lisa; (Seattle, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Spiration, Inc. d.b.a. Olympus Respiratory America |
Redmond |
WA |
US |
|
|
Assignee: |
Spiration, Inc. d.b.a. Olympus
Respiratory America
Redmond
WA
|
Family ID: |
59523814 |
Appl. No.: |
15/300687 |
Filed: |
March 30, 2015 |
PCT Filed: |
March 30, 2015 |
PCT NO: |
PCT/US2015/023421 |
371 Date: |
September 29, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61973142 |
Mar 31, 2014 |
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61973105 |
Mar 31, 2014 |
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61973110 |
Mar 31, 2014 |
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61973169 |
Mar 31, 2014 |
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61973137 |
Mar 31, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2090/061 20160201;
A61B 1/0661 20130101; A61B 17/12109 20130101; A61B 90/06 20160201;
A61B 5/1076 20130101; A61F 2002/043 20130101; A61B 1/0684 20130101;
A61B 17/12172 20130101; A61B 1/018 20130101; A61B 1/04 20130101;
A61B 5/107 20130101; A61B 1/0623 20130101; A61B 1/015 20130101;
A61B 1/0676 20130101; A61B 5/103 20130101; A61B 2017/00867
20130101; A61B 17/12036 20130101; A61B 1/267 20130101; A61B 5/1079
20130101; A61F 2220/0016 20130101; A61B 1/012 20130101; A61B 5/08
20130101; A61B 1/2676 20130101; A61F 2/04 20130101; A61B 2017/00699
20130101; A61B 17/12104 20130101; A61B 1/06 20130101; A61B 17/12177
20130101; A61B 1/07 20130101 |
International
Class: |
A61F 2/04 20060101
A61F002/04 |
Claims
1. A mechanism for anchoring endoluminal devices to a lumen, the
mechanism comprising: a hub member configured to be located at a
predetermined location inside the lumen; and a plurality of
anchoring struts, the plurality of anchoring struts comprising: a
spring portion attached to the hub member and configured to extend
or contract during expansion and contraction of the lumen; and an
anchoring portion connecting the spring portion to the lumen, the
anchoring portion configured to penetrate a portion of the lumen;
wherein the hub member is positioned on a plane with the anchoring
portions of the plurality of anchoring struts.
2. The mechanism of claim 1, wherein the anchoring portion
comprises a bidirectional anchoring tip comprising a first tip
pointed to a first direction and a second tip pointed to a second
direction at an angle from the first direction, wherein at least a
portion of the first tip penetrates the lumen in a transverse
direction to the lumen.
3. The mechanism of claim 1, wherein each of the plurality of
anchoring struts comprise equal lengths.
4. The mechanism of claim 1, wherein each of the spring portions of
the plurality of anchoring struts extends radially outward from the
hub member.
5. The mechanism of claim 1, wherein each of the spring portion of
the plurality of anchoring struts comprise a helically coiled
spring.
6. The mechanism of claim 1, wherein each of the spring portion of
the plurality of anchoring struts comprise bent strut members
configured to straighten during expansion of the lumen and bend
during contraction of the lumen.
7. The mechanism of claim 6, wherein the bent strut members
comprise a vortex shape when viewed along a longitudinal axis of
the lumen.
8. The mechanism of claim 6, wherein the bent strut members
comprise a spiral shape when viewed along a longitudinal axis of
the lumen.
9. The mechanism of claim 6, wherein each of the bent strut members
comprise undulating strut members having a substantially straight
shape when viewed in a transverse direction.
10. The mechanism of claim 6, wherein the bent strut members
comprise one or more thin portions and one or more thick portions
thicker than the thin portions.
11. The mechanism of claim 1, wherein the hub member comprises a
first hub and a second hub collinear and connected to the first
hub, wherein the plurality of anchoring struts are connected to the
first hub.
12. An endoluminal device comprising: an operative portion
configured to obstruct fluid flow inside the lumen; a hub member,
the hub member connected to the operative portion and comprising a
hub and a centering rod; and a plurality of anchoring struts, the
plurality of anchoring struts comprising: a strut portion attached
to the hub member and configured to expand and contract in response
to expansion and contraction of the lumen; and an anchoring portion
connecting the deflectable portion to the lumen; wherein the hub
member substantially remains on or near an axial line of the lumen
during movement of the lumen.
13. The device of claim 12, wherein the strut portion is connected
to a sliding hub configured to slide along a length of the
centering rod.
14. The device of claim 12, wherein the plurality of anchoring
struts comprise a plurality of quadrilateral-shaped members.
15. The device of claim 14, wherein each of the
quadrilateral-shaped members lies on a separate plane parallel to a
longitudinal axis of the device.
16. A mechanism for anchoring endoluminal devices to a lumen, the
mechanism comprising: a hub member; a plurality of distal anchoring
struts connected to the hub member and extending radially and
distally from the hub member and bending in a proximal direction,
each of the plurality of distal anchoring struts comprising
anchoring tips; and a plurality of opposing anchor struts connected
to the hub member and extending proximally and radially from the
hub member and bending in a distal direction, each of the plurality
of opposing anchor struts comprising opposing anchor tips; wherein
the distal anchoring struts and the opposing anchoring struts are
configured to pinch a portion of the lumen.
17. (canceled)
18. (canceled)
Description
REFERENCE TO RELATED APPLICATIONS
[0001] Any and all applications for which a foreign or domestic
priority claim is identified in the Application Data Sheet as filed
with the present application are hereby incorporated by reference
under 37 CFR 1.57. This application claims priority to U.S.
Provisional Patent Application No. 61/973,142, filed Mar. 31, 2014
(Atty. Ref. No. SPIRTN.106PR). The entire disclosure of the
foregoing application is hereby made part of this specification as
if set forth fully herein and incorporated by reference for all
purposes, for all that each contain.
BACKGROUND
[0002] This disclosure relates to anchoring mechanisms for devices
used inside lung airways.
RELATED ART
[0003] Struts having anchors are typically used to anchor devices
used inside airways to lungs. However, provided herein are devices
and methods that can help anchor devices used inside airways to
lungs using springs, for example.
SUMMARY
[0004] The present technology relates to anchoring mechanisms and
systems for endoluminal devices.
[0005] A mechanism for anchoring endoluminal devices to a lumen can
comprise a hub member. The hub member can be configured to be
located at a predetermined location inside the lumen. The mechanism
can comprise a plurality of anchoring struts. The plurality of
anchoring struts can comprise a spring portion. The spring portion
can be attached to the hub member. The spring portion can be
configured to extend or contract during expansion and contraction
of the lumen. The mechanism can comprise an anchoring portion. The
anchoring portion can connect the spring portion to the lumen. The
anchoring portion can be configured to penetrate a portion of the
lumen. The hub member can be positioned on a plane with the
anchoring portions of the plurality of anchoring struts.
[0006] The anchoring portion can comprise a bi-directional
anchoring tip. The bi-directional anchoring tip can comprise a
first tip pointed to a first direction. The bi-directional
anchoring tip can comprise a second tip pointed to a second
direction at an angle from the first direction. At least a portion
of the first tip can penetrate the lumen in a transverse direction
to the lumen. The plurality of anchoring struts can comprise equal
lengths.
[0007] Each of the spring portions of the plurality of anchoring
struts can extend radially outward from the hub member. Each of the
spring portion of the plurality of anchoring struts can comprise a
helically coiled spring. Each of the spring portion of the
plurality of anchoring struts can comprise bent strut members
configured to straighten during expansion of the lumen and bend
during contraction of the lumen.
[0008] The bent strut members can comprise a vortex shape when
viewed along a longitudinal axis of the lumen. The bent strut
members can comprise a spiral shape when viewed along a
longitudinal axis of the lumen. Each of the bent strut members can
comprise undulating strut members having a substantially straight
shape when viewed in a transverse direction.
[0009] The bent strut members can comprise one or more thin
portions and one or more thick portions thicker than the thin
portions. The hub member can comprise a first hub and a second hub
collinear and connected to the first hub. The plurality of
anchoring struts can be connected to the first hub.
[0010] An endoluminal device can comprise an operative portion. The
operative portion can be configured to obstruct fluid flow inside
the lumen. The endoluminal device can comprise a hub member. The
hub member can be connected to the operative portion. The hub
member can comprise a hub and a centering rod. The endoluminal
device can comprise a plurality of anchoring struts. The plurality
of anchoring struts can comprise a strut portion. The strut portion
can be attached to the hub member. The strut portion can be
configured to expand and contract in response to expansion and
contraction of the lumen. The anchoring portion can connect the
deflectable portion to the lumen. The hub member can substantially
remain on or near an axial line of the lumen during movement of the
lumen.
[0011] The strut portion can be connected to a sliding hub
configured to slide along a length of the centering rod. The
plurality of anchoring struts can comprise a plurality of
quadrilateral-shaped members. Each of the quadrilateral-shaped
members can lie on a separate plane parallel to a longitudinal axis
of the device.
[0012] A mechanism for anchoring endoluminal devices to a lumen can
comprise a hub member. A plurality of distal anchoring struts can
be connected to the hub member. The plurality of distal anchoring
struts can extend radially and distally from the hub member and
bend in a proximal direction. Each of the plurality of distal
anchoring struts can comprise anchoring tips. The mechanism for
anchoring endoluminal devices can comprise a plurality of opposing
anchor struts. The plurality of opposing anchoring struts can be
connected to the hub member. The plurality of opposing anchoring
struts can extend proximally and radially from the hub member and
bend in a distal direction. Each of the plurality of opposing
anchor struts can comprise opposing anchor tips. The distal
anchoring struts and the opposing anchoring struts can be
configured to pinch a portion of the lumen.
[0013] A mechanism for anchoring endoluminal devices to a lumen can
comprise a hub member. A plurality of anchoring struts can extend
radially outward and distally from the hub member. Each of the
plurality of anchoring struts can be configured to transition from
a straightened configuration to a curved configuration when
deployed in the lumen. Each of the plurality of anchoring struts
can have a length when in the straightened configuration. The
length of one or more of the plurality of anchor struts in the
straightened configuration can be at least 1.5 times the fully
expanded diameter of the lumen.
[0014] A mechanism for anchoring endoluminal devices to a lumen can
comprise an operative portion. The operative portion can comprise a
plurality of frame struts. Each frame strut can comprise a frame
strut tip. A hub member can be connected to a distal end of the
operative portion. A plurality of distal anchoring struts can
extend radially from the hub member and bend in a proximal
direction. Each distal anchoring strut can comprise an anchoring
tip. The anchor tips can be positioned between the hub member and
the frame strut tips. The frame strut tips and the anchoring tips
can be interposed when viewed in a transverse direction.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The following drawings and the associated descriptions are
provided to illustrate the present disclosure and do not limit the
scope of the claims.
[0016] FIG. 1 shows a schematic drawing of an example of a
spring-type anchoring mechanism.
[0017] FIG. 2 shows a schematic drawing of an example of a
spiral-type anchoring mechanism.
[0018] FIGS. 3A and 3B show perspective views of an example of a
vortex-type anchoring mechanism.
[0019] FIGS. 4A and 4B show a schematic drawing of an example of a
wave-type anchoring mechanism.
[0020] FIGS. 5A and 5B show a schematic drawing of an example of a
wave-type anchoring mechanism having bends near the hub.
[0021] FIG. 6 shows a perspective view an example of a wave-type
anchoring mechanism with proximal struts.
[0022] FIGS. 7A and 7B show schematic drawings of examples of
anchoring mechanisms having diamond-shaped anchoring struts.
[0023] FIGS. 8A and 8B show schematic drawings of an example
anchoring mechanism having bowtie-shaped anchoring struts.
[0024] FIGS. 9A and 9B show perspective views of an example of a
pinch-type anchoring mechanism.
[0025] FIG. 10 shows a schematic drawing of an example of an
elongated anchoring strut mechanism.
[0026] FIG. 1I shows an example shape of a pinch-type anchoring
mechanism having elongated distal anchors.
[0027] FIGS. 12A to 12C show an example of a pinch-type anchoring
mechanism having elongated distal anchors with an operative
portion.
[0028] FIGS. 13A to 13C show different views of an example of a
bi-directional anchoring tip.
[0029] FIG. 14A to 14C show an example of an anchoring mechanism
having interposing anchors.
[0030] FIGS. 15A and 15B show an example of an elastic connecting
portion.
[0031] FIGS. 16A and 16B show an example of an elastic connecting
portion used in a branching lumen.
[0032] These and other features will now be described with
reference to the drawings summarized above. The drawings and the
associated descriptions are provided to illustrate embodiments and
not to limit the scope of any claim. Throughout the drawings,
reference numbers may be reused to indicate correspondence between
referenced elements.
DETAILED DESCRIPTION OF EMBODIMENTS
[0033] Certain anchoring mechanisms for devices used inside airways
to lungs can have anchoring struts that can apply an outward force
to a lumen (e.g., a lung airway). Such anchoring mechanisms can
allow devices to be securely positioned during expansion and
contraction of the lumen. Anchoring mechanisms can enter the lumen
in a compressed state when devices having valves are being inserted
into the lumen. Outward force of the anchoring mechanism can allow
the anchoring mechanism to reach its fully expanded state during
operation within the lumen. The outward force can maintain a slight
outward pressure on the lumen during exhalation.
[0034] In some cases, the outward force of the anchors can deform
the lumen walls. For example, the outward force can push the lumen
walls radially outward from a central axis of the lumen. Expansion
of the anchors and/or deformation of the lumen walls can cause an
operative portion (e.g., a valve portion) of the device to be
pulled towards the anchors (e.g., in a distal direction) as the
anchors move outward and away from the axis of the lumen. Such
"settling" of the anchors and operative portion of the device can
occur gradually or quickly, depending on the geometry, elasticity,
and/or other features of the lumen in which the device is
implanted.
[0035] Pulling of the operative portion during lumen expansion can
cause the operative portion to move longitudinally from its initial
placement position. The dimensions of the device can be calibrated
to account for such movement before placing the device in the
lumen. Such calibration can be done by, for example, adjusting the
placement of the operative portion (e.g., by placing the operative
portion proximal of the intended final location), though a precise
adjustment to account for the movement can be difficult. In some
cases, movement of the device occurs over a time period beyond
which the physician can reasonably observe using a visualization
device such as a bronchoscope. In some cases, it can be difficult
for the physician to approximate the final resting place of the
device. A displacement of a device resulting from the bodily
movement can result in unwanted side-branch ventilation due to the
sealing portion being moved from its original position, which can
compromise the effectiveness of such devices. In some cases, the
valve of a device can become over-compressed when moved (e.g., in a
distal direction). In some cases, the valve of a device can be
moved to a portion of a lumen larger than the valve, thereby
reducing or eliminating the efficacy of the valve.
[0036] Some mechanisms use stent anchoring designs that can
overpower the lumen wall and press against the lumen wall to about
the full diameter of the device. Such mechanisms can become affixed
to the final resting position in the lumen immediately upon placing
the device inside the lumen. However, such mechanisms can present
problems over time because those mechanisms may not adjust properly
with the expansion and contraction of airways to lungs caused by
breathing. The tissue of the lumen may remodel to accommodate the
device diameter, possibly causing the device to be loosened and/or
coughed out.
[0037] Disclosed herein are anchoring mechanisms that can track the
movement of a lumen wall (e.g., during breathing and/or coughing)
and can allow the sealing portion of a valve to remain at a
substantially consistent position in the airway as the anchoring
mechanisms transition to a final resting position. In some cases,
the anchoring mechanisms apply a vortexly expanding outward force
with little or no axial component to the lumen wall. In some cases,
the anchoring mechanisms apply a force with an axial vector in the
proximal direction to push the device in the proximal direction as
the lumen lengthens (e.g., during re-expansion of a collapsed
lung).
Spring-Type Anchoring Mechanism
[0038] An anchoring mechanism that can adapt to change in lumen
dimensions can be used to place a medical device to a lumen. The
medical device can be an endoluminal medical device. The
endoluminal medical device used with an anchoring mechanism can
include, for example, stents, sensors, valves, etc. The lumen can
include, for example, veins, airways, digestive tracts, etc. FIG. 1
shows a schematic transverse cross-sectional view of an example
shape of a spring-type anchoring mechanism used inside a lumen. The
spring type anchoring mechanism 100 can comprise a hub 120 and a
plurality of spring-type anchoring struts 130. The spring-type
anchoring struts 130 can comprise an anchoring tip 140.
[0039] The hub 120 can be a collet configured to bundle the
plurality of spring-type anchoring struts 130. The hub 120 can
comprise a centering rod and a forceps knob, not shown. The
spring-type anchoring struts 130 can be arranged radially from the
hub 120. The spring-type anchoring struts 130 can comprise coiled
springs, bent springs, or other expandable geometries and
configurations. The anchoring struts 130 used in the spring-type
anchoring mechanism 100 can comprise an elastic structure
configured to expand or contract according to the movement of the
lumen. For example, the plurality of anchoring struts 130 can
comprise an expansion spring, such as the spring-type anchoring
mechanism shown schematically in FIG. 1. In some embodiments, the
anchoring struts 130 are formed as compression springs.
[0040] The anchoring tip 140 can be configured to removably attach
to the lumen 110. In some embodiments, the anchoring tip 140 can be
configured to penetrate a portion of the lumen 110. For example,
the anchoring tip 140 can comprise a tapered shape. The anchoring
tip 140 can comprise a first piercing mechanism. The first piercing
mechanism can comprise a shank. The anchoring tip 140 can comprise
an anchor projection 150. The anchor projection 150 can comprise a
second piercing mechanism forming an angle with the spring-type
anchoring struts 130. For example, as shown schematically in FIG.
1, the anchor projection 150 can form about a 90 degree angle from
the radius of the lumen 110. The anchor projection 150 can form an
angle less than 90 degrees, about 75 degrees from the radius of the
lumen, for example. The anchor projection 150 can comprise a tack.
The anchor projection 150 can be configured to allow the anchoring
tip to penetrate a portion of the lumen 110. For example, the
anchor projection 150 can have a length equal to or less than about
2 times the diameter of the anchoring struts.
[0041] In some embodiments, the anchor projection 150 is configured
to limit degree of penetration of the anchoring tip 140. For
example, the anchor projection 150 can comprise an additional pad
portion pointing in a vertical (e.g., circumferential) direction
with respect to the hub 120. The anchor projection 150 can be
positioned to rest against an inner surface of the lumen 110 to
inhibit or prevent penetration of the anchoring tip 140 beyond a
predetermined distance.
[0042] Dimensional changes of the lumen 110 can include changes in
longitudinal dimension and changes in radial dimension. The lumen
110 can comprise a largest fully expanded diameter and a smallest
fully contracted diameter. The plurality of spring-type anchoring
struts 130 can extend radially from the hub 120 to contact the
lumen 110. Each of the struts 130 can have an extended length
(e.g., a length to which the struts 130 extend if unobstructed). In
some embodiments, the extended length of the struts is greater than
an expanded radius of the lumen 110 in which the struts 130 are
deployed. In some embodiments, the extended length of the struts
130 is greater than 1.1 times, greater than 1.25 times, greater
than 1.4 times, greater than 2 times, and/or greater than 4 times
the expanded radius of the lumen 100. Many variations are
possible.
[0043] The length of the plurality of spring-type anchoring struts
130 can comprise a coiled length (e.g., a minimum length the struts
130 can assume when the struts 130 are compressed). In some
embodiments, the coiled length of the struts 130 is less than the
radius of the lumen 110 in the smallest fully contracted diameter
of the lumen 110. For example, the coiled length of the struts 130
can be less than about 0.9 times the contracted diameter, less than
about 0.75 times the contracted diameter, less than 0.6 times the
contracted diameter, and/or less than about 0.5 times the
contracted diameter of the lumen 100. Many variations are
possible.
[0044] The spring type anchoring mechanism 100 can comprise an even
number of spring-type anchoring struts 130. For example, as shown
in FIG. 1, the spring type anchoring mechanism 100 can comprise six
spring-type anchoring struts 130. An even number of spring-type
anchoring struts 130 can be used, for example, to counteract
expansion and/or contraction forces of opposing spring-type
anchoring struts 130. In some embodiments, the anchoring mechanism
100 includes an odd number of anchoring struts 130.
[0045] The spring-type anchoring struts 130 can comprise varying
lengths. For example, two or more spring-type anchoring struts 130
can have an equal length and a third spring-type anchoring strut
130 can have a length greater than or equal to the other two. In
some cases, each of the struts 130 has a different length.
[0046] The hub 120 can be disposed on or near the longitudinal axis
of the lumen 110 when the anchoring mechanism 100 is deployed. The
spring-type anchoring struts 130 can at least partially uncoil
during expansion of the lumen 110 and maintain contact with the
lumen 110. The spring-type anchoring struts 130 can coil during
contraction of the lumen 110 and apply a radial outward force to
the lumen 110.
[0047] The struts 130 can be configured to maintain the hub 120 in
a relatively stable position along a length of the lumen 110 in
which the anchoring mechanism 100 before and/or after settling
(e.g., expansion of the airway due to outward force of the struts
130) of the anchoring mechanism 100. The longitudinal movement
(e.g., movement along a length of the lumen 110) of the hub 120
during and/or before settling can be limited to be within about 1
mm. The movement of the hub 120 can be limited to be, within about
2 mm, within about 0.5 mm, within about 0.3 mm, and/or within about
0.2 mm during and/or before settling.
[0048] A user may deploy the anchoring mechanism 100 by using a
delivery device, such as an endoscope. The spring type anchoring
mechanism 100 can be folded and transported within a catheter used
with an endoscope. The spring type anchoring mechanism 100 can be
deployed by being pushed out of the catheter. In some embodiments,
the anchoring mechanism 100 can be deployed by withdrawing the
catheter from the anchoring mechanism 100 at a deployment site. The
spring-type anchoring struts 130 can expand radially outward to
contact the lumen 110 once placed outside the catheter. The
spring-type anchoring struts 130 can exert a radial outward force
on the lumen wall 110. The radial outward force can allow each of
the anchoring tips 140 to penetrate the lumen 110.
[0049] The hub 120 and the anchoring tip 140 can be on the same or
substantially same transverse plane upon deployment. In some
embodiments, the anchoring mechanism 100 can comprise two or more
anchoring struts 130. The spring-type anchoring struts 130 can
comprise a combination of elastic and static anchoring struts. For
example, the spring-type anchoring struts 130 can comprise two
spring-shaped elastic anchoring struts and one stiff, static
anchoring strut. The hub 120 can comprise an axial bearing. The hub
120 can be positioned off-center. For example, the hub 120 can be
located adjacent to wall of the lumen 110. The hub 120 can comprise
various different shapes. For example, the hub can have a round,
polygonal, oval-shaped, or other-shaped cross-section in a plane
perpendicular to a longitudinal axis of the lumen 110. The
anchoring tip 140 can comprise a blunt tip, such that no portion of
the anchoring tip penetrates the lumen 110. The anchoring tip 140
having a blunt tip can comprise a traction surface. For example,
the traction surface can comprise a plurality of cleats.
Spiral-Type Anchoring Mechanism
[0050] Anchoring struts can comprise a spiral shape, or a torsion
spring shape. The spiral shape can be used, for example, to exert
torsional force during expansion and contraction of the lumen. FIG.
2 shows a schematic transverse cross-sectional view of an example
shape of a spiral type anchoring mechanism 200. The spiral type
anchoring mechanism 200 can comprise a hub 220, a plurality of
anchoring struts 230, and anchoring tips 240. The plurality of
anchoring struts 230 can comprise an elongate (e.g., generally
straight) portion 232 and a spiral portion 233. The anchoring tips
240 can be configured to penetrate the lumen 210.
[0051] The hub 220 can be placed on or near the longitudinal axis
of the lumen 210. The hub 220 of the spiral type anchoring
mechanism 200 can remain substantially in the same axial position
irrespective of the movement of the lumen. The hub 120 can rotate
as the spirals expand. For example, the hub 120 can rotate
independently from an operative portion of the medical device
during lumen expansion or contraction. In some embodiments, the hub
120 is rotatably locked with and connected to the operative
portion. The operative portion can be, for example, a lung airway
valve.
[0052] During an expansion and contraction of the lumen 110, the
spiral type anchoring mechanism 200 can inhibit, reduce, or prevent
displacement of a medical device while allowing the hub 220 to
remain substantially at its original position. For example, during
expansion of the lumen, the spiral portion 233 of the anchoring
struts 230 can straighten. The hub 220 can remain suspended from
the lumen wall and remain substantially at its original position.
In some embodiments, the anchoring mechanism 200 is configured to
maintain the hub 200 (e.g., and, consequently, the operative
portion) in a relatively constant position along a length of the
lumen 210 in which the mechanism 200 is deployed.
[0053] The plurality of anchoring struts 230 can be made of shape
memory material, such as Nitinol. In some embodiments, the struts
230 are constructed from another, resilient and/or flexible
material. The plurality of anchoring struts 230 can comprise a
coiled length. The coiled length can comprise the shortest length
between the hub 220 and the end of the anchoring tip 240 when the
struts 230 are radially compressed. In some embodiments, the coiled
length of the struts 230 is less than about 0.9 times, less than
about 0.75 times, less than about 0.6 times, less than about 0.4
times, and/or less than about 0.25 times a radius of the lumen 210.
The plurality of anchoring struts 230 can comprise an uncoiled
length larger than a radius of lumen 210. For example, the straight
length of the anchoring struts 230 can be more than 2 times larger,
more than 1.5 times larger, and/or more than 1.1 times larger than
a radius of the lumen 210.
[0054] The spiral shapes anchoring mechanism 200 can be transported
across a catheter by being folded into the catheter prior to
deployment. The anchoring struts 230 can be coiled further to be
transported through the catheter. The spiral shape anchoring
mechanism 200 can uncoil to its pre-formed spiral shape when pushed
out of the catheter. In some embodiments, the anchoring mechanism
200 uncoils upon withdrawal of the catheter from the struts 230 at
a deployment site in the lumen 210. The anchoring tips 240 can
contact the lumen 210 once deployed, and exert an outward force
from the hub 220 to the lumen 210. The anchoring tips 240 can
penetrate the flesh of the lumen 210 by exerting outward force. In
some embodiments, the anchoring tips 240 include pads or other
mechanisms configured to limit the depth to which the tips 240
penetrate the lumen wall.
[0055] The anchoring struts 230 can be straightened to be
transported through the catheter prior to deployment. The hub 220
can be a dual hub configured to allow rotation of the hub 220
without rotating the attached portion of the medical device (e.g.
the operative portion). The spiral shaped anchoring mechanism 200
can comprise three or more anchoring struts 230. The anchoring
struts 230 can comprise a combination of different spring shapes.
For example, the anchoring struts 230 can comprise a plurality of
spring-type anchoring struts 130 (e.g., shown in FIG. 1) helically
coiled and forming a spiral around the hub 220.
Vortex-Type Anchoring Mechanism
[0056] An anchoring mechanism can comprise a plurality of flexible
struts that are bent in a same circumferential direction to form a
vortex shape when viewed in a transverse cross-section. The
flexible vortex struts can bend or straighten, bending further
during contraction of the lumen and straightening as the lumen
expands. FIGS. 3A and 3B show perspective views of an example shape
of a vortex-type anchoring mechanism. The vortex-type anchoring
mechanism 300 can comprise a hub 320, a plurality of flexible
anchoring struts 332, a plurality of proximal struts 336, a center
rod 360, and/or a forceps knob 362. The hub 320 can comprise a
dual-hub configuration having a distal hub 322 and a proximal hub
324. The flexible anchoring struts 332 can comprise an anchoring
tip 340. The proximal struts 336 can comprise a bent contact
surface 338. The proximal struts 336 can comprise frame struts of
an operative portion 1135 (e.g., shown in FIGS. 12A to 12C).
[0057] The flexible anchoring struts 332 can extend radially
outward from the distal hub 322. The proximal hub 324 can be
connected to and/or form a monolithic part with the distal hub 322.
The proximal struts 336 can extend radially and proximally from the
proximal hub 324. The proximal struts 336 can form a basket. The
proximal hub 324 can be a collet. The center rod 362 can be
connected to the proximal hub 324 and extend proximally from the
center hub. The center rod 362 can connect the hub 320 and the
forceps knob 362. The forceps knob 362 can be shaped and sized to
be grasped by a forceps. The plurality of flexible anchoring struts
332 can be configured to radially expand and exert an outward force
on the lumen. The bent surface 338 of the plurality of proximal
struts 336 can comprise portions of the proximal struts that bend
at an angle from the rest of each proximal strut member 336 towards
the longitudinal axis, or the center rod 360. The bent contact
surface 338 can be used, for example, to inhibit or prevent trauma
to the lumen wall by the proximal struts 336.
[0058] The distal hub 322 and the proximal hub 324 can comprise
collinear cylindrical structures. The distal hub 322 and the
proximal hub 324 can comprise cylindrical structures having
different diameters. For example, the diameter of the distal hub
322 can be smaller than the diameter of the proximal hub 324. The
smaller diameter of the distal hub 322 can be shaped and sized, for
example, to allow the plurality of distal struts to coil and fit
inside a delivery catheter. Each of the plurality of proximal
struts 336 can have a straightened length. The straightened length
can comprise the length of the proximal strut member at a fully
straightened state with no bends. The straightened length can be
less than 1.5 times the length of the center rod 362. The
straightened length can be equal to or less than the length of the
center rod 362. In some cases, the straightened length can be
greater than 1.5 times the length of the center rod 362.
[0059] The stiffness of the flexible anchoring struts 332 can be
tuned to counteract the forces (e.g., tension and compression)
occurring during expansion of the struts 332. For example,
stiffness of some portions in the struts 332 may be greater than
the stiffness in other portions. Areas near the hub 320 and near
the anchor tip 340 can be relatively stiff, while near the middle
of the struts can be made more flexible to allow bending. The
stiffness can be tuned by changing dimensions and/or shape of
portions of the anchoring struts 332. For example, the plurality of
anchoring struts 332 can comprise bent portions, thin portions,
thick portions, and/or spiral portions.
[0060] The vortex shape anchoring mechanism 300 can be folded and
transported across a delivery catheter. The flexible anchoring
struts 332 can be coiled in the direction of the bend to fold and
fit inside a catheter. For example, the flexible anchoring struts
332 shown in FIGS. 3A to 3B can be coiled by rotating the hub 320
relative to the anchoring tip 340 in a counter-clockwise direction.
The proximal struts 336 can be straightened to fold and fit inside
a catheter. The proximal struts 336 can be straightened along the
direction of the length of the center rod 362.
[0061] The flexible anchoring struts 332 in a fully coiled state
can have a cross-sectional diameter equal to or less than 1.5 times
larger than the diameter of the proximal hub. The flexible
anchoring struts 332 in a fully coiled state can have a
cross-sectional diameter equal to or less than the diameter of the
proximal hub. The plurality of proximal struts 336 in a fully
straightened state can have a cross-sectional diameter equal to or
less than 1.5 times larger than the diameter of the proximal hub.
The plurality of proximal struts 336 in a fully straightened state
can have a cross-sectional diameter equal to or less than the
diameter of the proximal hub.
[0062] The vortex strut anchoring mechanism 300 can counteract
movement of the lumen. For example, the vortex strut anchoring
mechanism 300 can adjust to expand during lumen expansion and
contract during lumen contraction. The anchoring tips 340 can
remain in a substantially same transverse plane (e.g.,
perpendicular to the centerline of the lumen) during lumen
expansion and contraction. For example, the flexible anchoring
struts 330 can be bent further to have a smaller diameter, such
that the anchoring tip 340 and the hub 320 can remain in a
substantially constant transverse plane. The arc of the curvature
of the anchoring struts 332 can straighten more as the lumen
expands, while contact points and the hub remain in substantially
the same plane. The stiffness of the anchoring struts can be tuned
to counteract distal and proximal forces applied when the anchoring
struts 330 expand. In some embodiments, the struts 332 are
configured to remain in substantially the same transverse plane
during and/or after settling of the device 300.
[0063] The plurality of proximal struts 336 can comprise two or
more bent surfaces 338. For example, a proximal strut 336 can have
two connected bent surfaces that form two included angles from the
proximal strut 336. Two or more bent surfaces 338 can be used, for
example, to allow different atraumatic contact surfaces to contact
the lumen during expansion and contraction. For example, bent
surfaces 338 can comprise a first surface configured to contact the
lumen at an expanded state, and a second surface configured to
contact the lumen at the contracted state.
[0064] The plurality of flexible anchoring struts 332 can comprise
anchoring tips 340. For example, the plurality of flexible
anchoring struts 332 can comprise multiple anchoring structures
pointing in different directions. For example, the anchoring tip
340 can comprise a bi-directional anchoring tip 640 (shown in FIG.
6). In some embodiments, the anchor tips 340 comprise atraumatic
and/or high friction tips configured to engage with the wall of a
lumen.
[0065] The plurality of flexible anchoring struts 332 can comprise
a spiral shape, such as the spiral-type anchoring struts 230 shown
and described above in reference to FIG. 2. The proximal struts 336
can be used to counteract movements of the attached medical device
in the proximal direction.
[0066] The position of the proximal struts 336 and the flexible
anchoring struts 330 can be reversed. For example, the proximal
struts 336 can be positioned distally relative to the flexible
anchoring struts 330. The proximal struts 336 can extend in the
opposite direction, such that the bent contact surface 338 can be
positioned distally relative to the hub 320. The vortex strut
anchoring mechanism 300 can comprise different number of flexible
anchoring struts 330 as the number of proximal struts 336. The
vortex strut anchoring mechanism 300 can comprise the same number
of flexible anchoring struts 330 as the number of proximal struts
336. For example, where the vortex strut anchoring mechanism 300
has three flexible anchoring struts 330, the mechanism 300 can
comprise three proximal struts 336. In some embodiments, each of
proximal struts 336 and each of flexible anchoring struts 330 can
be connected and can comprise portions of singular strut members.
For example, a plurality of singular strut structures can be
bundled together between the two ends of each strut structure by a
collet.
Wave-Type Anchoring Mechanism
[0067] In some embodiments, and anchoring mechanism 400 can include
struts having a wave-like shape when viewed from a longitudinal
cross-sectional view of the lumen. FIGS. 4A and 4B show a schematic
drawing of an example shape of a wave-type anchoring mechanism 400.
The wave-type anchoring mechanism 400 can include a hub 420, a
center rod 460, and a plurality of undulating anchoring struts 430.
The undulating anchoring struts 430 can comprise one or more thick
portions 433A, one or more thin portions 433B, and anchoring tips
440. The undulating anchoring struts 430 can comprise a
substantially straight shape when viewed in a transverse direction.
The wave-type anchoring mechanism 400 can limit displacement of the
hub 420 as the lumen 410 shifts between a contracted state (FIG.
4A) and an expanded state (FIG. 4B). In some cases, the anchoring
mechanism 400 limits displacement of the hub 420 (e.g., and,
consequently, an operative portion connected to the hub 400) when
the mechanism 400 settles in the membrane 450.
[0068] The hub 420 can connect the plurality of undulating
anchoring struts 430 to the center rod 460. For example, the
wave-type anchoring mechanism 400 can comprise two undulating
anchoring struts 430 connected to the center rod 460 via the hub
420. In some embodiments, the anchoring mechanism 400 includes
three or more anchoring struts 430 emanating from the hub 420. The
undulating anchoring struts 430 can comprise one or more inflection
points and undulation points. For example, as shown in FIGS. 4A and
4B, a wave-type anchoring mechanism 400 can have at least one
undulation point on each strut 433.
[0069] The anchoring tip 440 can be located proximally to the
location of the hub 420 at a distance D1 when the anchoring struts
430 are in a first, less-expanded configuration. For example, the
distance between the anchoring tip 440 and the hub 420 in a fully
contracted state lumen (FIG. 4A) can comprise a first distance D1.
The distance between the anchoring tip 440 and the hub 420 in a
fully expanded state lumen (FIG. 4B) can comprise a second distance
D2. The displacement of the hub 420 can be limited such that the
difference between the first distance D1 and the second distance D2
can be less than 0.5 mm. The difference between the first distance
D1 and the second distance D2 can be less than 0.1 mm. The
difference between the first distance D1 and the second distance D2
can be less than 0.05 mm. In some cases, the difference between the
first distance D1 and the second distance D2 can be less than 0.02
mm.
[0070] The anchor struts 430 can have non-uniform thickness between
the hub 420 and the anchor tips 440. For example, the anchor struts
430 can include a thick portion 433A which can be more rigid than a
thinner portion (e.g. having a greater degree of freedom). For
example, the thick portion 433A can retain its bent shape while
experiencing deflection during expansion of the lumen 410 and/or
during settling of the anchoring mechanism 400. The anchoring
mechanism 400 can include a thin portion 433B may deflect to a
greater degree than the thick portion 433A during expansion of the
lumen 410. The thick portion 433A and the thin portion 433B can
comprise portions of undulating anchoring strut 430 having
different structures and dimensions. For example, the thick portion
433A can comprise a portion of the strut member 430 having a
greater thickness along a direction transverse to the longitudinal
direction of the lumen 410 while the thin portion 433B comprises a
strut portion having a greater thickness along a longitudinal
direction of the lumen 410. Such a configuration can be used to
allow the thick portion 433A to withstand stress from repeated
expansion and contraction motion of the lumen 410.
[0071] As shown in FIGS. 4A and 4B, the wave-type anchoring
mechanism 400 can comprise an anchoring tip 440. The anchoring tips
440 can be curved and pointing at a distal direction. The wave-type
anchoring mechanism 400 can be placed proximally or distally of an
operative portion of a medical device, such as a valve.
[0072] The undulating anchoring struts 430 can comprise struts
having different lengths, shapes, points of inflection/undulation,
stiffness, etc. For example, FIGS. 5A and 5B show an example shape
of a wave-type anchoring mechanism having a bow-shaped bend near
the hub 520. The wave-type anchoring mechanism 500 having a sharper
bend near the hub 520 can comprise a center rod 560, a hub 520, and
a plurality of anchoring struts 530. The plurality of anchoring
struts 530 can comprise a thick portion 533A, a thin portion 533B,
a bow-shaped bend 533C, and anchoring tips 540. The bow-shaped bend
533B can comprise a different structure from the remainder of the
anchoring struts 530. For example, the bow-shaped bend 533B can
comprise a bent shape in a transverse direction.
[0073] The anchoring tip 440 can be located on the same transverse
plane as the hub 420. The anchoring tip 440 can point in a proximal
or distal direction. In some embodiments the anchoring tip 440
includes a pad portion configured to limit a depth to which the
anchoring tip 440 penetrates the lumens 410. The wave-type
anchoring struts 430 can extend radially from the hub 420. For
example, FIG. 6 shows a perspective view of an example shape of a
wave-type anchoring mechanism 600 comprising undulating struts 632.
The anchoring mechanism 600 can share many or most of the
characteristics and features of the anchoring mechanism 300
described above, wherein the distal anchors 632 comprise undulating
struts rather than the vertical struts 332 described above, and
wherein like parts include like numbers (e.g., proximal struts 336
v. proximal struts 636). The hub 620 can comprise a proximal hub
622 and a distal hub 624. The plurality of vortex undulating struts
632 can comprise a thick portion 633A, a thin portion 633B, and a
bi-directional anchoring tip 640. The bi-directional anchoring tip
640 can comprise a first anchoring tip 640A and a second anchoring
tip 640B. The second anchoring tip 640B can be configured to limit
the extent to which the first anchoring tip 640A.
[0074] As shown in FIG. 6, the wave-type anchoring mechanism
comprising undulating struts 600 can comprise three or more
undulating struts 632. The bi-directional tip 640 can comprise the
bi-directional tip 1335A, 1335B shown and described in reference to
FIGS. 13A to 13C of this application.
Diamond-Shaped Anchoring Mechanism
[0075] FIGS. 7A and 7B schematically show examples of a diamond
shaped anchoring mechanism. The diamond shaped anchoring mechanism
700 can comprise a forceps knob 762, a center rod 760 extending
distally from the forceps knob 762, a first hub 720 connected to
the center rod 760 distal from the forceps knob 762, a second hub
722 connected to the center rod 760 distal of the first hub 720,
and/or a plurality of diamond-shaped anchoring struts 730. The
plurality of diamond-shaped anchoring struts 730 can comprise a
proximal portion 734, a distal portion 732, a distal point 795, and
anchoring tips 740. In some embodiments, an operative portion 750
is connected to the center rod 760 between the first hub 720 and
the forceps knob 762.
[0076] The center rod 760 can connect the forceps knob 762 and the
distal point 795. For example, the distal point of the struts 730
can be connected to the second hub 722. The proximal portion 734
and the distal portion 732 can comprise two sides of a diamond. The
proximal portion 734 and the distal portion 732 can comprise a
singular strut member wherein the proximal portion 734 is connected
to the first hub 720.
[0077] The proximal portion 734 and the distal portion 732 can form
an included angle. For example, in a first state (e.g. before
settling of the device 700 and/or before expansion of the lumen
710), the proximal portion 734 and the distal portion 732 can form
an angle less than about 150 degrees. The proximal portion 734 and
the distal portion 732 can form an angle less than about 80 degrees
in the original state. The proximal portion 734 and the distal
portion 732 can form an angle less than about 60 degrees in the
original state. The proximal portion 734 and the distal portion 732
can form an angle less than about 45 degrees in the original
state.
[0078] The anchoring tip 740 can comprise an anchoring structure.
For example, the anchoring tip can comprise a barb, high friction
pad, or other structure configured to penetrate and/or frictionally
engage with the lumen 710. The anchoring tip 740 can comprise a
bi-directional anchoring tip. For example, the anchoring tip 740
can comprise bi-directional tip shown and described in reference to
FIGS. 13A to 13C of this application. In some embodiments, the
anchoring tip 740 can comprise cleats, studs, tracks, etc.
[0079] As shown in FIGS. 7A-7B, when viewed in a longitudinal cross
section, the diamond-shaped anchoring struts 730 can comprise a
diamond shape, or two mirroring triangles. A proximal end of the
triangles can be connected to the first hub 720. In some
embodiments the distal end of the triangles is connected to the
second hub 722. The struts 730 can be configured to expand and/or
contract in a radial direction in reaction to expansion and
contraction of the lumen 710 (e.g., due to breathing, settling of
the device 700, or other circumstances).
[0080] The struts 730 can be configured to expand/contract in a
radial direction with limited or no movement of the center rod 760
along a length of the lumen 710. For example, the first hub 720 can
be a sliding hub (FIG. 7A). The hub 720 can comprise an annular
shape with a hollow center shaped and sized to slide along the
center rod 760. The hub 720 (e.g., and the proximal end of the
struts 730) can be configured to slide in a distal direction when
the struts 730 expand. The mechanism 700 can include a proximal
stop 743 configured to limit the proximal movement of the first hub
720 along the center rod 760.
[0081] In some embodiments the second hub 722 is configured to
slide along the center rod 760 (FIG. 7B). In some cases, the second
hub 722 is slidable and the first hub 720 is fixed on the center
rod 760. The second hub 722 (e.g., and the distal end of the struts
730) can be configured to slide in a proximal direction when the
struts 730 expand. In some embodiments, the mechanism 700 includes
a distal stop 745 configured to limit distal movement of the second
hub 722 when the second hub 722 is a sliding hub (FIG. 7B).
[0082] In some cases, sliding of the first hub 720 or second hub
722 can permit radial expansion and contraction of the struts 730
(e.g., in reaction to inhalation/exhalation and/or settling of the
mechanism 700) with little or no movement of the center rod 760
along a length of the lumen 710. Limiting or preventing movement of
the center rod 760 along the length of the lumen 710 can facilitate
constant or semi-constant positioning of the operative portion
750.
[0083] The proximal portion 734 and the distal portion 732 can have
approximately equal lengths. In some embodiments, the proximal
portion 734 and the distal portion 732 comprise different lengths.
The diamond-shaped anchoring mechanism 700 can comprise a
telescopically sliding rod. For example, a sliding rod can slidably
connect the center rod 760 to the distal point 795. The center rod
760 can comprise a hollow center shaped and sized to accept the
sliding rod.
Bowtie-Shaped Anchoring Mechanism
[0084] FIGS. 8A and 8B show an example shape of an anchoring
mechanism having bowtie-shaped anchoring struts 834 used with an
operative portion 825. The bowtie-shaped anchoring mechanism 800
can comprise a forceps knob 862 and a center rod 860 connected to
and extending distally from the forceps knob 862. An operative
portion 825 (e.g., valve) can be connected to the center rod 860
distal from the forceps knob 862. The mechanism 800 can include a
hub 820 connected to the center rod 860 distal of the operative
portion 825.
[0085] As illustrated, the mechanism 800 can include a plurality of
bowtie-shaped anchoring struts 830. The struts 830 can be connected
to and extend radially from the hub 820. The bowtie-shaped
anchoring struts 830 can comprise a plurality of
quadrilateral-shaped members. The struts 830 can each comprise a
proximal portion 834, a distal portion 832, and anchoring tips 850.
The proximal portion 834 can comprise a proximal point 835A. The
distal portion 832 can comprise a distal point 835B. The proximal
and distal points 835A, 835B can comprise bendable or articulated
joints. The bowtie-shaped anchoring struts 800 can be used with an
operative portion 825, such as a valve used in a lung airway
valve.
[0086] The shape of the bowtie-shaped anchoring struts 830 can
change during movement of the lumen 815 (e.g., during
inhalation/exhalation and/or during settling of the mechanism 800).
For example, the distance between axis of the lumen 815 and the
anchoring tips 850 can grow larger during expansion of the lumen
wall. The proximal point 835A and the distal point 835B can move
away from each other during contraction of the lumen 810. The
proximal point 835A and the distal point 835B can move closer
during expansion of the lumen 810.
[0087] In some embodiments, the points 835A, 835B of each strut 830
lie on a plane substantially parallel a longitudinal axis of the
lumen 815. In some cases, the points 835A, 835B of each strut 830
lie on a plane substantially perpendicular to the longitudinal axis
of the lumen 815. In some embodiments, the points 835A, 835B of
each strut 830 lie on planes neither perpendicular nor parallel to
the longitudinal axis of the lumen 815. Many variations are
possible.
[0088] The struts 830 can be configured to expand and/or contract
with little or no movement of the hub 820 (e.g., and, consequently,
the operative portion 825) along a length of the lumen 815. For
example, radial movement of the anchor portions 850 of the struts
830 can occur on a substantially constant plane perpendicular to a
length of the lumen 815.
Opposing Anchoring Struts Mechanism
[0089] In some cases, an anchoring mechanism can include one or
more anchors configured to engage with a lumen wall to inhibit or
prevent movement of an operative portion of a device in a distal
direction. For example, two or more anchoring struts can be used to
pinch a portion of the lumen.
[0090] FIGS. 9A and 9B show perspective views of an example shape
of a pinch-type anchoring mechanism 900. The mechanism 900 can
include a hub 920 and a plurality of distal struts 934 extending
distally and/or radially outward from the hub 920. The mechanism
900 can include a plurality opposing struts 933 extending radially
outward from the hub 920 proximal of the distal struts 934. The
plurality of distal struts 934 can comprise distal anchoring tips
940A. The opposing struts can comprise opposing anchoring tips
940B. The distal and opposing anchoring tips 940A, 940B can
comprise bi-directional anchoring tips (shown in FIGS. 13A to
13C).
[0091] In some embodiments, the mechanism 900 includes a plurality
of proximal struts 935 extending proximally from the hub 920. The
plurality of proximal struts 935 can comprise frame struts of an
operative portion 1235 (Shown in FIGS. 12A to 12C).
[0092] The plurality of distal struts 934 can comprise a strut
member comprising one or more bends. For example, as shown in FIGS.
9A and 9B, the plurality of distal struts 934 can comprise two
bends, each bends curving each distal strut member 934 in a
proximal direction. The opposing struts 933 can comprise strut
members mirroring the distal struts 934 with respect to a plane
perpendicular to a longitudinal axis of the center post 960. For
example, the opposing struts 933 can comprise strut members
extending radially outward from the hub 920 and initially extending
in the proximal direction and bending in the distal direction as
shown in FIGS. 9A and 9B. The opposing struts 933 can comprise
opposing anchoring tips 940B. The anchoring tips 940A, 940B can
comprise a second tip 954. The second tips 954 of the anchoring
tips 940A, 940B can be configured to limit a depth to which the
anchoring tips 940A, 940B (e.g., or piercing portions 952 thereof)
penetrate a lumen wall. For example, the second tip 954 of the
proximal anchoring tip 940A can point in the proximal direction,
while the second tip 954 of the opposing anchoring tip 940B can
point in the distal direction. In some embodiments, the second tips
954 of the anchor tips 940A. 940B point in the same direction.
[0093] The hub 920 can comprise a dual-hub configuration, as
described above in reference to FIGS. 3A and 3B. The hub can
comprise a distal hub 922 and a proximal hub 924. As shown in FIGS.
9A and 9B, the distal struts 934 can extend radially from the
distal hub 922. The opposing struts 933 can extend radially from
the proximal hub 924.
[0094] The opposing struts 933 can be configured to counteract
forces created from movement of the pinch-type anchoring mechanism
900 in a distal direction (e.g., due to settling of the mechanism
900). The distal struts 934 and the opposing struts 933 can be
configured for use inside a lumen while minimizing pinching of the
lumen. Such configuration can be used, for example, to minimize
trauma to the lumen.
[0095] The pinching of the distal struts 934 and the opposing
struts 933 can cause the wall of the lumen to become pleated (see,
e.g., FIGS. 12A-12C). The pleating of the lumen wall can be used to
allow point loads to be applied to wall while permitting use of
proximal struts 933 having reduced radial stiffness compared to the
distal struts 934. For example, the pleating of the lumen wall can
permit the proximal struts 933 to contact and/or penetrate the
lumen wall at a smaller angle with respect to the longitudinal axis
of the mechanism 900 than the angle of contact when no pleating is
present. The pleating of the lumen wall and the minimal opposing
forces can be used to inhibit or reduce the likelihood of pressure
necrosis which can be caused by the directly opposing forces by the
opposing struts. The opposing struts 933 can be shorter than the
distal struts 934. The distal struts 934 can comprise elongated
anchoring mechanism shown and described in reference to FIG.
10.
[0096] The pinch-type anchoring mechanism 900 can be configured to
fit inside a delivery catheter. For example, as illustrated in
FIGS. 9A and 9B, the distal struts 934 can be straightened in the
distal direction and the opposing struts 933 can be straightened in
the proximal direction to fit inside a catheter. A user may place
the pinch-type anchoring mechanism 900 at a desired location inside
lumen and push the pinch-type anchoring mechanism 900 distally. In
some cases, the mechanism 900 is maneuvered to an installation site
using a catheter and the catheter is withdrawn from the mechanism
900 to deploy the mechanism at the installation site. Once the
distal struts 934 have been released, portions of the distal
anchoring tips 940A can connect the pinch-type anchoring mechanism
900 to the lumen and penetrate the lumen. The user may pull the
catheter to further release the pinch-type anchoring mechanism 900
such that the opposing struts 933 can be released. The opposing
struts 933 can shift shape from a straightened state inside the
catheter and return to its original fully curved shape. The
opposing struts 933 can form a relatively straight shape within the
catheter and can shift shape to curve in the distal direction upon
deployment from the catheter. The opposing anchoring tips 940B of
the opposing struts 933 can be lodged into the lumen. The
deflection force applied to the lumen as the distal struts 934 and
the opposing struts 933 return to its respective original shape can
pinch the lumen, forming a pleat. In some cases, changes in shape
of the pinch-type anchoring mechanism 900 can be triggered or
actuated by changes in temperature, by passing an electronic
current to the strut members, physical manipulation, etc.
[0097] The distal struts 934 and the opposing struts 933 can
comprise struts having different lengths, shapes, points of
inflection/undulation, stiffness, etc. For example, the distal
struts 934 and the opposing struts 933 can comprise strut members
having a curved shape, without bends.
Elongated Distal Anchors
[0098] Anchoring mechanisms having elongated strut members can be
used to reduce movement of the medical device caused by bodily
movements and/or settling of the anchoring mechanism. The degree of
movement of a medical device can be less with anchoring mechanisms
using longer strut members, compared to mechanisms using shorter
strut members. Longer strut members can expand in a large arc,
thereby reducing the axial movement of the endoluminal device as
the strut members expand to an equilibrium position (e.g., settle).
FIG. 10 schematically shows an example shape of an elongated struts
anchoring mechanism. The elongated struts anchoring mechanism 1000
can comprise a plurality of elongated anchoring struts 1034 and a
hub 1020.
[0099] The elongated anchoring struts 1034 can be configured to
reduce or limit the amount of longitudinal movement of a device
connected to the hub 1020. The plurality of elongated anchoring
struts 1034 can comprise anchoring tips 1040. The anchoring tips
1040 can be in a first location P1 in a fully contracted lumen. The
anchoring tips 1040 can be in a second location P2 in a fully
expanded state. The anchoring tips 1040 can travel at a
longitudinal travel distance D3 between P1 and P2. The longitudinal
travel distance D3 can be reduced by having elongated anchoring
struts 1040. For example, the longitudinal travel distance D3 can
be less than 0.1 mm. The longitudinal travel distance D3 can be
less than 0.05 mm. The longitudinal travel distance D3 can be less
than 0.02 mm. In some cases, the longitudinal travel distance D3
can be less than 0.01 mm. Many variations are possible.
[0100] The elongated anchoring struts 1034 can comprise curved
strut members, as shown schematically in FIG. 10. The elongated
anchoring struts 1034 can comprise a straight length, the straight
length corresponding to the length of strut members when the strut
members are straightened. The straight length can be longer than
the diameter of the expanded lumen. For example, the elongated
anchoring struts 1034 can have a straight length of at least about
1.5 times the diameter of the expanded lumen. The elongated
anchoring struts 1034 can have a straight length of at least about
two times the diameter of the expanded lumen. The elongated
anchoring struts 1034 can have a straight length of at least about
three times the diameter of the expanded lumen. The elongated
anchoring struts 1034 can have a straight length of at least about
four times the diameter of the expanded lumen. In some embodiments,
the struts 1034 have a straight length between about one and four
times the diameter of the expanded lumen. Many variations are
possible.
[0101] A user may select shape and dimension of the elongated
struts anchoring mechanism 1000 based on the lumen 1010. The
straight length and the curvature of the elongated anchoring struts
1034 can be adjusted to correspond to lumen size changes. For
example, for a lumen that shows little change in size between its
fully expanded state and fully contracted state, strut members
having a greater degree of curvature, and/or having a shorter
straightened length, can be used. A user may also calibrate the
distance traveled by the hub 1020 by adjusting the straight length
and/or the curvature. The user can limit the amount of longitudinal
distance traveled by the hub 1020 to be less than 0.02 mm by
selecting struts 1040 having a certain length, for example.
[0102] The elongated anchoring struts 1034 can comprise strut
members of different lengths and configurations. FIG. 11 shows an
example shape of a pinch-type anchoring mechanism 1100 having a
plurality of elongated distal anchor struts 1134. The pinch-type
anchoring mechanism 1100 can comprise a hub 1175. The mechanism
1100 can include plurality of elongated distal anchoring struts
1134 connected to and extending from the hub 1175 in a distal
direction. The mechanism 1100 can include a plurality of opposing
struts 1133 connected to the hub 1175 and positioned proximal to
the distal struts 1134. The elongated distal anchoring struts 1134
can comprise a distal anchoring tip 1136. The distal anchoring tip
1136 can comprise a first anchoring tip 1136A and a second
anchoring tip 1136B. The plurality of opposing anchors can comprise
an opposing anchor tip 1190.
[0103] As illustrated in FIG. 11, the opposing struts 1133 can
extend radially outward from the hub 1175 and extend in a distal
direction. The opposing anchor tip 1190 can extend at an angle from
the opposing struts 1133. The opposing anchor tip 1190 can form an
angle between about 90.degree. and 170.degree. from the opposing
struts 1133. The first anchoring tip 1136A of the elongated distal
anchoring struts 1134 can extend in the same direction as the
elongated distal anchoring struts 1134. The second anchoring tip
1136B can point in the proximal direction and form an angle with
the first anchor 1136A. The angle can be about 30 degrees to about
170 degrees. The angle can be about 45 degrees to about 150
degrees. The angle can be about 60 degrees to about 120 degrees.
The angle can be about 80 degrees to about 100 degrees. The angle
can be about 90 degrees. In some embodiments, the second anchoring
tip 1136B is configured to interface with a wall of the lumen and
limit a depth to which the first anchor tip 1136A pierces the lumen
wall.
[0104] In some embodiments, the distal anchoring tip 1136 can
comprise a bi-directional anchoring tip (e.g., as shown in FIGS.
13A to 13C). The distal anchoring tip 1136 and the opposing anchor
tip 1190 can be configured to pinch a lumen wall. For example, the
elongated distal anchoring struts 1136 and the opposing struts 1133
can be configured to oppose each other to pinch a lumen wall. In
some embodiments, the opposing struts 1133 are configured to
inhibit, limit, or prevent distal movement of the operative portion
(e.g., valve) connected to the hub 1175 when the distal anchors
1134 settle in the lumen wall.
[0105] FIGS. 12A-12C shows an example shape of a pinch-type
anchoring mechanism having a plurality of elongated distal anchor
struts used with a medical device inside a lumen. As shown in FIG.
12A, the pinch-type anchoring mechanism having a plurality of
elongated distal anchor struts 1100 can comprise a pinch-type
anchoring mechanism 1100 and an operative portion 1135. The
operative portion 1135 can comprise a lung airway valve. The hub
1175 can connect the pinch-type anchoring mechanism 1100 to the
operative portion 1135.
[0106] As seen in FIGS. 12A to 12C, the elongated distal anchoring
struts 1134 can transition from a straightened configuration and
gradually return to a curved configuration. As seen in FIGS. 12A to
12C, the lumen 1110 can form a lumen wall pleat 1115 as the
elongated distal anchoring struts 1134 changes shape. The lumen
wall pleat 1115 can form between the elongated distal anchoring
struts 1134 and opposing struts 1133. In some embodiments, the
opposing struts 1133 include a bifurcated tip including a pad
configured to limit an extent to which the opposing struts 1133
pierce the lumen 1100.
[0107] The elongated distal anchoring struts 1134 can comprise a
memory shape material. The elongated distal anchoring struts 1134
can change shape in response to electronic actuation, temperature
changes, physical manipulation, dimensional changes resulting from
releasing the device from a catheter, etc. For example, the
elongated distal anchoring struts 1134 in a straightened form as
shown in FIG. 12A can be activated by passing an electric current.
The elongated distal anchoring struts 1134 can form a curved shape
when activated as shown in FIG. 12C. The elongated distal anchoring
struts 1134 in a curved form in FIG. 12C can be activated to
straighten. For example, activating the elongated distal anchoring
struts 1134 in FIG. 12C can straighten the elongated distal
anchoring struts 1134 to form a straightened shape in FIG. 12A. In
some embodiments, the struts 1133, 1134 are biased to their
respective deployed configurations and are mechanically
straightened (e.g., via a catheter and/or forceps) to fit within a
catheter or working channel of an endoscope.
Anchoring Tips
[0108] Bodily movements (e.g., inhalation and/or exhalation,
coughing, etc.) can cause a medical device used inside the lumen to
move in different directions. Anchoring tips pointing in different
directions can anchor a device to counteract such movement of the
device. FIGS. 13A to 13C show different views an example shape of a
bi-directional anchoring tip 1340. The bi-directional anchoring tip
1340 can be connected to a strut member 1330. The strut member 1330
can comprise pre-formed bends 1392A, 1392B. The strut member 1330
can be connected to an anchor hub 1375. In some embodiments, the
anchor hub 1375 is connected to an operative portion (e.g., valve)
of a medical device. The bi-directional anchoring tip 1340 can
comprise a first anchoring tip 1335A and a second anchoring tip
1335B. In some embodiments, the first and/or second anchoring tips
1335A, 1335B extend from a fork body 1337.
[0109] The first anchoring tip 1335A and the second anchoring tip
1335B can extend from the fork body 1337. The fork body 1337 can
connect the first anchoring tip 1335A and the second anchoring tip
1335B to the strut member 1330. In some embodiments, the anchoring
tips 1335A, 1335B are formed from introducing a slit to a distal
end of the strut member 1330 to split the distal end of the strut
member 1330 into two separate portions (e.g., the first and second
tips 1335A, 1335B). The first anchoring tip 1335A can extend
generally in the same direction as the strut member 1330. For
example, the first anchoring tip 1335A can extend in a radial
direction from the hub 1375. The second anchoring tip 1335B can
comprise a bend. The second anchoring tip 1335B can form an angle
with the first anchoring tip 1335A. For example, the second
anchoring tip 1335B can bend at about 10 degrees to about 170
degrees from the fork body 1337. The first anchoring tip 1335A and
the second anchoring tip 1335B can comprise different tip
structures. For example, the first anchoring tip 1335A can comprise
a sharp tip structure, such as the tip structure for the first
anchoring tip 1335A shown in FIGS. 13A-13C. The second anchoring
tip 1335B can comprise a blunt tip structure as shown in FIGS.
13A-13C.
[0110] The first anchoring tip 1335A can be configured to penetrate
the lumen. The second anchoring tip 1335B can be configured to
limit depth of penetration by the first anchoring tip 1335A. The
second anchoring tip 1335B can point proximally, as shown in FIG.
13A. The second anchoring tip 1335B can be configured to exert
radial outward force to the lumen wall. For example, the second
anchoring tip 1335B can be configured to inhibit or prevent the
movement of the device in a longitudinal direction. The proximal
direction of the second anchoring tip 1335B can be used to obstruct
movement of a medical device used with the bi-directional anchoring
tip 1300 in a proximal direction inside a lumen.
[0111] The second anchoring tip 1335B can be located on the strut
member 1330, away from the first anchoring tip 1335A. The second
anchoring tip 1335B can comprise a sharp-edged bend. The first
anchoring tip 1335A can form an angle with the fork body 1337.
Membrane-Frame Struts
[0112] An endoluminal device having a shorter overall axial length
can be useful. For example, an endoluminal device with shorter
axial length can be used in a short lumen. The shorter axial length
of the device can be used where the anchoring portion needs to be
close to the operative portion, for example, to avoid anchoring a
device on abraded patches of lumen wall. In some cases, use of a
shorter device can be beneficial when the device is implanted
adjacent an intersection of multiple branches of an airway or other
body lumen.
[0113] FIGS. 14A to 14C show perspective views of an example
endoluminal device 1400 having interposing strut members. The
device 1400 can include a hub 1420. In some embodiments, the device
1400 includes an anchoring portion 1432 connected to the hub and an
operative portion 1435 connected to the hub 1475. The anchoring
portion 1432 can comprise a plurality of anchoring struts 1432. The
plurality of anchoring struts 1432 can comprise anchoring tips
1440. The anchoring tips can comprise bi-directional tips 1335A,
1335B (shown in FIGS. 13A and 13B). The operative portion 1425 can
include membrane struts 1435 and a membrane 1463 attached to the
membrane struts 1435. The operative portion 1425 (e.g., the
membrane struts 1435) can be connected to and extend proximally
from the hub 1475. The device 1400 can include a center rod 1460
connected to the hub 1475 and positioned between the membrane
struts 1435 and a forceps knob 1462 on a proximal end of the center
rod 1460.
[0114] The anchoring struts 1432 can comprise a bent shape having
anchoring tips 1440 pointing in a radially-outward direction, as
shown in FIGS. 14A to 14C. In some embodiments, the anchor struts
1432 include a pad or other structure adjacent the tips 1440 to
limit an extent to which the tips 1440 penetrate an airway wall. As
shown in FIG. 14B, the anchoring struts 1432 can be interposed with
the frame struts 1435 around a circumference of the device 1400,
such that the anchoring tips 1440 can be interposed with the frame
strut tips 1436 when viewed in a transverse direction. In some
cases, the number of anchoring tips 1440 and anchor struts 1432
matches the number of struts 1435. Interposing of the struts 1435,
1432 can be used, for example, to minimize the total diameter of
the endoluminal device 1400 when compressed within a delivery
catheter.
[0115] The anchoring struts 1432 can extend outward from the hub
1475 and bend in a proximal direction as shown in FIGS. 14A-14C. In
some embodiments, the anchor struts 1432 are configured to exert a
radially-outward force on a lumen in which the device 1400 is
deployed. The operative portion 1435 can be disposed proximally to
the anchoring portion 1432 when placed inside the lumen. When
placed inside the lumen, the frame strut tips 1436 of the operative
portion 1435 and the anchoring tips 1440 can be placed apart at a
distance D4. The distance D4 between the anchoring tips 1440 and
the frame strut tips 1436 of the operative portion 1425 can be
large enough to reduce the risk of contact between the tips 1440
and the membrane 1463. The distance D4 can be about 0.02 mm to
about 5 mm. The distance D4 can be about 0.05 mm to about 4 mm. The
distance D4 can be about 0.1 mm to about 3 mm. The distance D4 can
be about 0.15 mm to about 2 mm. The distance D4 can be about 0.2 mm
to about 1 mm.
[0116] Positioning the anchoring tips 1440 near the frame strut
tips 1436 can reduce movement of the operative portion 1425 when
the anchor tips 1440 settle in the walls of the lumen in which the
device 1400 is deployed. For example, the anchoring struts 1432 can
be configured to limit movement of the operative portion 1435 to be
less than about 0.2 mm. The anchoring struts 1432 can be configured
to limit movement of the operative portion 1435 to be less than
about 0.15 mm. The anchoring struts 1432 can be configured to limit
movement of the operative portion 1435 to be less than about 0.05
mm. The anchoring struts 1432 can be configured to limit movement
of the operative portion 1435 to be less than about 0.02 mm. The
anchoring struts 1432 can be configured to limit movement of the
operative portion 1435 to be less than about 0.01 mm.
[0117] The anchoring struts 1432 can comprise a plurality of
pre-formed bends. In some cases, anchoring struts 1432 can have a
curved shape without identifiable bends. The anchoring struts 1432
can have uniform thickness along a length of the struts 1432. In
some embodiments, some portion of the struts 1432 is thicker than
another portion of the struts 1432. The thick portions can be
configured to have less flexibility than thinner portions. For
example, the thinner portions can be configured to allow greater
bending than the thicker portions.
[0118] The endoluminal device 1400 can be transported using a
delivery catheter. For example, the interposing anchoring struts
1432 can be folded together with the frame struts 1435 while
interposing the frame struts 1435 to fit inside the catheter. The
endoluminal device 1400 can be deployed by being pushed out of the
catheter. In some embodiments, the endoluminal device 1400 is
deployed by withdrawing the catheter from the endoluminal device
1400 when the device 1400 is positioned at the deployment site. The
endoluminal device 1400 can be pushed out such that the hub 1475,
the anchoring tip 1440, and the membrane strut tips 1432 can leave
the catheter sequentially. Once the anchoring tip 1440 leaves the
catheter, the anchoring tip 1440 can latch onto the surface of the
lumen 1410. A user can pull the catheter away from the frame struts
1435 once the anchoring tip 1440 is latched onto the lumen
1410.
[0119] In some embodiments, the anchoring struts 1432 having a
pre-formed bent shape can be straightened to extend at a distal
direction from the hub 1475 to fit inside and be transported across
the catheter. The anchoring struts 1432 can comprise a different
number of struts as the number of the frame struts 1435A.
Connecting Member
[0120] Anchoring struts can be coupled to an operative portion by
an extendable and/or flexible connecting member. FIGS. 15A and 15B
show an example of an endoluminal device 1500 having an extendable
connecting member 1560. The endoluminal device 1500 can comprise an
operative portion 1535, a connecting member 1560 connected to the
operative portion 1535, and an anchoring portion 1530 connected to
the connecting member 1560. The anchoring portion 1530 can comprise
a distal hub 1575B, anchoring struts 1532 connected to and
extending from the distal hub 1575B, and anchoring tips 1540. The
anchoring tips 1540 can comprise a first tip 1536A and a second tip
1536B. The second tips 1536B can be configured to limit a depth to
which the first tips 1536A pierce into the walls of a lumen in
which the endoluminal device 1500 is installed. The operative
portion 1535 can comprise a proximal hub 1575A, a plurality of
frame struts 1535A connected to and extending from the proximal hub
1575A, and a membrane 1535B connected to the frame struts
1535A.
[0121] The anchoring portion 1530 can be disposed distally from the
operative portion 1535. The anchoring struts 1530 can extend
radially from the distal hub 1575B and generally in a distal
direction. The frame struts 1535A can comprise a bent surface 938
(as shown in FIG. 9). The bent surface 937 can be configured to
minimize trauma to the lumen 1510. The frame struts 1535A can
extend proximally from the proximal hub 1575A. The connecting
member 1560 can connect the distal hub 1575B and the proximal hub
1575A. The connecting member 1560 can connect the anchoring portion
1530 and the operative portion 1535. The connecting member 1560 can
be extendable. For example, the connecting member 1560 can be a
helical spring as shown in FIGS. 15A and 15B.
[0122] In a first configuration shown in FIG. ISA, the connecting
member 1560 can contract to bring the operative portion 1535 and
the anchoring portion 1530 close together. In a second
configuration shown in FIG. 15B, the connecting member 1560 can
extend, and the operative portion 1535 and the anchoring portion
1530 can be spaced farther apart from each other. The distance
between the proximal hub 1575A and the distal hub 1575B can be
greater in the second configuration compared to the first
configuration.
[0123] The connecting member 1560 can be extended and/or contracted
in response to change in lumen dimension. The connecting member
1560 can be sufficiently elastic to allow axial movement of the
anchoring portion 1530 without displacing the operative portion
1535. In some embodiments, the anchoring portion 1530 can move away
from the operative portion 1535, as the anchor struts 1532 and
lumen walls 1515 expand outward. In some cases, movement of the
anchoring portion 1530 away from the operative portion 1535 can be
accomplished with little or no movement of the operative portion
1535 toward the anchoring portion 1530.
[0124] The connecting member 1560 can comprise a tensile strength
sufficient to hold the operative portion 1535 in place, regardless
of change in lumen 1510 dimension. For example, the connecting
member 1560 can be configured to counteract the contraction of the
lumen 1510, such that while the connecting mechanism 1560 initially
extends during lumen contraction, the strength of the connecting
mechanism 1560 can spring back to its original length and re-expand
the lumen 1510. The spring portion 1560 can comprise an elastic
structure, such as an elastomer. For example, the spring portion
1560 can comprise synthetic rubber, silicone, etc.
Connecting Member in Bifurcating Lumen
[0125] The endoluminal device 1500 can be used in bifurcating
lumen, such as bifurcating airways. The extendable connecting
member 1560 can be used in airways having small diameters. FIGS.
16A and 16B show an example of an endoluminal device 1500 having an
extendable connecting member used in a bifurcating lumen 1610. The
bifurcating lumen 1610 can comprise a first lumen 1615A and a
second lumen 1615B. The first and second lumens 1615A, 1615B can
comprise different dimensions. For example, the first lumen 1615A
can comprise a smaller diameter than the diameter of the second
lumen 1615B. The first and second lumens 1615A. 1615B can expand or
contract individually or together.
[0126] FIG. 16A shows the endoluminal device 1500 disposed mostly
in the first lumen 1615A. The anchoring portion 1530 can be
disposed distally in the first lumen 1615A and the operative
portion 1535 can be disposed on or near an entrance of the first
lumen 1615A. The operative portion 1535 can contact the first lumen
1615A at an expanded contact diameter 1590B. The contact diameter
1590B can comprise a diameter of the first lumen 1615A in which
portions of an outer surface of the operative portion comes in
contact with the lumen 1615A.
[0127] FIG. 16B shows the first lumen 1615A in a contracted state.
In a contracted state, the first lumen 1615A can exert a force on
the operative portion 1535 and portions of the operative portion
1535 can be disposed outside of the first lumen 1615A. For example,
the operative portion 1535 can contact the first lumen 1615A at a
contracted contact diameter 1590A. The contracted contact diameter
1590A can be closer to the proximal hub 1575A than the expanded
contact diameter 1590B. The contracted contact diameter 1590A can
be smaller than the expanded contact diameter 1590B.
[0128] The connecting portion 1560 can elastically extend to allow
the operative portion 1535 to move proximally while the first lumen
1615A contracts. The connecting portion 1560 can pull the operative
portion 1535 distally as the first lumen 1615A expands. The elastic
extension and the pulling of the connecting portion can apply a
sufficient counter force to keep the endoluminal device 1500 seated
inside the airway, without causing the anchoring mechanism to be
removed from its position. The distance which the connecting
portion 1560 can extend can be determined by the angle of the cone
of the valve portion and the diameter of the airway wall that the
operative portion 1535 covers.
[0129] The struts 1535A in the operative portion 1535 can rest
against an opening of the first lumen 1615A and into a larger lumen
1605 to counteract pulling from the anchoring portion 1530 as shown
in FIGS. 16A and 16B. The anchoring portion 1530 can remain in the
same location in the first lumen 1615A during expansion and
contraction. In some cases, the anchoring portion 1530 moves
distally within the first lumen 1615A during settling of the
anchoring portion 1530. For example, in the expanded first lumen
1615A in FIG. 16A, the connecting member 1560 can be at a first
length D5. In the contracted first lumen 1615A of shown in FIG.
16B, the connecting member 1560 can be at a second length D6. The
first length D5 can be shorter than the second length D6. The
operative portion 1535 can move further out to the larger lumen
1605 in a proximal direction as the first lumen 1615A contracts.
The distance between the proximal hub 1575A and the distal hub
1575B can increase during the contraction of the lumen 1615A. The
distance between the proximal hub 1575A and the distal hub 1575B
can decrease during the expansion of the lumen 1615A. The elastic
force generated by the connecting portion 1560 can be tuned to hold
the operative 1535 portion against the opening.
[0130] The operative portion 1535, while suited for a larger
airway, can be used in a smaller airway with an opening to a larger
airway. As shown in FIGS. 16A and 16B, the operative portion 1535
can be nested in the proximal end of the first lumen 1615A. For
example, the first lumen 1615A can comprise a contact diameter
1590A smaller than an outermost diameter of the operative portion
1535. The outermost diameter of the operative portion 1535 can be
the largest diameter of the operative portion 1535. A portion of
the operative portion 1535 can be located inside the first lumen
1615A while the remaining portion of the operative portion 1535 can
extend outside of the entrance of the first lumen 1615A. The shape
and size of the operative portion 1535 can be configured to ensure
airflow through second lumen 1615B.
[0131] Although these inventions have been disclosed in the context
of certain preferred embodiments and examples, it will be
understood by those skilled in the art that the present inventions
extend beyond the specifically disclosed embodiments to other
alternative embodiments and/or uses of the inventions and obvious
modifications and equivalents thereof. In addition, while several
variations of the inventions have been shown and described in
detail, other modifications, which are within the scope of these
inventions, will be readily apparent to those of skill in the art
based upon this disclosure. It is also contemplated that various
combinations or sub-combinations of the specific features and
aspects of the embodiments can be made and still fall within the
scope of the inventions. It should be understood that various
features and aspects of the disclosed embodiments can be combined
with or substituted for one another in order to form varying modes
of the disclosed inventions. Thus, it is intended that the scope of
at least some of the present inventions herein disclosed should not
be limited by the particular disclosed embodiments described
above.
* * * * *