U.S. patent application number 14/954910 was filed with the patent office on 2016-07-14 for articulable anchor.
The applicant listed for this patent is Spiration, Inc.. Invention is credited to Clinton Lee Finger, James Kutsko, Seung Yi.
Application Number | 20160199066 14/954910 |
Document ID | / |
Family ID | 38560205 |
Filed Date | 2016-07-14 |
United States Patent
Application |
20160199066 |
Kind Code |
A1 |
Kutsko; James ; et
al. |
July 14, 2016 |
ARTICULABLE ANCHOR
Abstract
Embodiments disclosed herein relate to devices implantable into
a human lung, for example to reduce the volume of air trapped in a
diseased portion of the lung to prevent inhalation while permitting
expiration out of the diseased portion. In some embodiments, the
device comprises a distal portion with an anchor system that may
anchor the device into tissue of an air passageway wall, and the
distal portion may be connected to a proximal portion via a
flexible portion that permits the distal portion to articulate
substantially with respect to the proximal portion, such that the
distal portion and the proximal portion may be non-collinear along
a longitudinal axis of the distal portion. This may facilitate
implantation of the device into a non-linear air passageway.
Inventors: |
Kutsko; James; (Carnation,
WA) ; Yi; Seung; (Aliso Viejo, CA) ; Finger;
Clinton Lee; (Bellevue, WA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Spiration, Inc. |
Redmond |
WA |
US |
|
|
Family ID: |
38560205 |
Appl. No.: |
14/954910 |
Filed: |
November 30, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14106459 |
Dec 13, 2013 |
9198669 |
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14954910 |
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13457346 |
Apr 26, 2012 |
8647392 |
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14106459 |
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12754394 |
Apr 5, 2010 |
8454708 |
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13457346 |
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11585415 |
Oct 24, 2006 |
7691151 |
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12754394 |
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60787995 |
Mar 31, 2006 |
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Current U.S.
Class: |
606/191 |
Current CPC
Class: |
A61F 2002/043 20130101;
A61F 2220/0016 20130101; A61F 2002/828 20130101; A61F 2310/00011
20130101; A61B 17/12172 20130101; A61F 2220/0091 20130101; A61F
2230/0006 20130101; A61B 17/12104 20130101; A61B 17/12022 20130101;
A61F 2/04 20130101; A61F 2/24 20130101 |
International
Class: |
A61B 17/12 20060101
A61B017/12; A61F 2/04 20060101 A61F002/04 |
Claims
1. (canceled)
2. An implantable device configured to be secured within an air
passageway, the device comprising: an anchor system comprising at
least one piercing tip and being configured to engage tissue of an
air passageway wall; a proximal valve portion; and a flexible
connecting portion connected to both the proximal valve portion and
the anchor system and positioned there between, the flexible
connecting portion configured to apply a force to the proximal
valve portion to enhance seating between the proximal valve portion
and airway passage.
3. The device of claim 2 wherein the proximal valve portion is
configured to move in a distal and a proximal direction with
respect to the anchor system in response to exhalation and
inhalation when implanted in the air passageway.
4. The device of claim 2, wherein the flexible connecting portion
comprises a coil spring.
5. The device of claim 2, wherein the flexible connecting portion
comprises a tube in which slots of an alternating pattern are
cut.
6. The device of claim 2, wherein the flexible connecting portion
comprises a mesh.
7. The device of claim 2, wherein the anchor system comprises one
or more stops configured to limit a depth to which the piercing tip
engages tissue of the air passageway wall.
8. An implantable device configured to be secured within an air
passageway, the device comprising: an anchor system having portions
configured to pierce tissue of an air passageway wall; a proximal
one-way valve; and a connecting portion having a first end
connected to the proximal one-way valve and a second end connected
to the anchor system, the connecting portion configured to apply
distal force on the one-way valve to enhance seating between the
proximal valve portion and airway passage.
9. The device of claim 8, wherein the proximal one-way valve is
configured to move in a distal and a proximal direction with
respect to the anchor system in response to exhalation and
inhalation when implanted in the air passageway.
10. The device of claim 8, wherein the connecting portion comprises
a coil spring.
11. The device of claim 8, wherein the connecting portion comprises
a tube in which slots of an alternating pattern are cut.
12. The device of claim 8, wherein the connecting portion comprises
a mesh.
13. An implantable device configured to be secured within an air
passageway, the device comprising: a frame having a concave side
and a convex side; a membrane supported by the frame; an anchor
system comprising a plurality of anchor arms; and a connecting
portion having a first end connected to the frame and a second end
connected to the anchor system, the connecting portion configured
to bias the frame toward the anchor system.
14. The device of claim 13, wherein the frame, anchor system, and
connecting portion are formed as a unitary part.
15. The device of claim 13, wherein the convex side of the frame is
connected to the connecting portion.
16. The device of claim 13, wherein the concave side of the frame
faces away from the anchor system.
17. The device of claim 13, wherein a distance between the first
and second ends of the connecting portion is configured to change
in response to inhalation and exhalation when the device is
implanted in the air passageway.
18. The device of claim 13, wherein the connecting portion is
constructed by cutting a tube.
19. The device of claim 13, wherein the membrane is carried on the
entire frame.
20. The device of claim 13, wherein each of the anchor arms
comprises a first end connected to the connecting portion and a
second end positioned away from the connecting portion.
21. The device of claim 20, wherein the second end of each of the
anchor arms is positioned entirely distal of the connecting portion
and of the frame when the device is implanted in the air passageway
and when the concave side of the frame faces a proximal direction
Description
RELATED APPLICATIONS
[0001] This application is a continuation U.S. application Ser. No.
14/106,459, filed Dec. 13, 2013, which is a continuation of U.S.
application Ser. No. 13/457,346, filed Apr. 26, 2012, now issued as
U.S. Pat. No. 8,647,392, which is a continuation of U.S.
application Ser. No. 12/754,394, filed Apr. 5, 2010, now issued as
U.S. Pat. No. 8,454,708, which is a continuation of U.S.
application Ser. No. 11/585,415, filed Oct. 24, 2006, now issued as
U.S. Pat. No. 7,691,151, which claims the benefit under 35 U.S.C.
119(c) to U.S. Provisional Patent Application No. 60/787,995, filed
Mar. 31, 2006. The foregoing applications are hereby incorporated
by reference in their entirety.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The inventions relate in general to the field of pulmonary
treatments, and specifically to systems, devices, and methods for
treating a patient's lung or portion thereof.
[0004] 2. Description of the Related Art
[0005] Chronic Obstructive Pulmonary Disease ("COPD") has become a
major cause of morbidity and mortality in the United States. COPD
is typically characterized by the presence of airflow obstructions
due to chronic bronchitis or emphysema. The airflow obstructions in
COPD are due largely to structural abnormalities in the smaller
airways in the lungs.
[0006] Mortality, health-related costs, and the segment of the
population having adverse effects due to COPD are substantial. COPD
is a progressive disease that can severely affect a person's
ability to accomplish normal tasks. One method of treating COPD is
the insertion of one-way valves into lumens in the lung. The valves
inhibit inhalation, but permit exhalation of air already within the
lung. The lung presents challenge in mounting such valves because
lumens within it are rarely linear over a useful distance.
Accordingly, there is a need for a device to permit mounting of
valves within non-linear lumens in the lung.
SUMMARY OF THE INVENTION
[0007] Accordingly, one aspect of the invention comprises an
implantable device for providing substantially one-way flow of air
through a lumen in a human lung to reduce the volume of air trapped
in a diseased portion of the lung. The implantable device occludes
the lumen to substantially prevent inhalation while substantially
permitting expiration out of said diseased portion of the lung. The
implantable device is deployable into the lumen with a
catheter.
[0008] One aspect of an embodiment of the implantable device can
comprise a one-way valve being generally umbrella-shaped in
configuration. The valve is collapsible for containment within a
delivery catheter and expandable in situ when deployed. The valve
substantially occludes the lumen. The valve is configured so that
when deployed in an orientation to substantially preclude
inhalation, inhaled air is prevented from flowing past the valve
into said lung by capturing said air within the umbrella-shaped
valve. The air exerts an outward force on the umbrella shape and
forces said valve to tightly engage the lumen. The valve is
configured to permit expiration to occur between the perimeter of
the valve and the lumen.
[0009] The valve also defines a longitudinal axis and comprises a
plurality of metal struts that define a generally bell-shaped
frame. Each of the struts have a first end that curves slightly
inward towards the longitudinal axis of said implantable device
when deployed and a second end proximal a junction of the second
ends of the other struts, The valve also has a resilient membrane
that wraps around at least a part of the metal struts and is
supported by them. The membrane extends from the junction of the
plurality of metal struts toward the first end of said struts. The
valve also comprises a central post with a first part that extends
within the membrane from the junction of said plurality of metal
struts at the center of the bell-shaped frame. The post has a
flange at an end distal from the strut junction. The flange is
configured to permit deployment, positioning, and recapture of said
implantable device. The central post further comprises a second
part that extends axially outside the membrane.
[0010] Another aspect of the invention comprises an anchor for
securing the implantable device within the lumen by inhibiting
migration of the device once deployed. The anchor comprises a
plurality of resilient arms extending outwardly and radially from
the second part of the central post. Each of said arms are
configured so as to be collapsible for containment within a
delivery catheter and expandable to engage the lumen when deployed
in situ. Each of the arms comprises a generally tapered distal end
to permit the arm to penetrate the wall of the lumen. The arms
further comprise a planar member proximal the tapered distal end
and positioned at an angle to the arm to limit advancement of said
arm into the lumen wall by contacting the surface of said lumen
wall.
[0011] Another aspect of the invention comprises a mechanism
connecting the one-way valve to the anchor and being disposed
generally along the longitudinal axis when the device is in a
collapsed state. The mechanism is configured to permit the valve to
be oriented at an angle to the anchor when deployed, thereby
allowing the anchor to be positioned in a section of the lumen that
is at an angle to a section of said lumen in which the one-way
valve is positioned. The mechanism comprises at least one connector
at a first end to connect the mechanism to the valve. In some
embodiments, the mechanism comprises a flexible member configured
to be articulable to permit angled orientation of the anchor. In
some embodiments, the flexible member comprises a helical spring.
In some embodiments, the flexible member comprises a generally
cylindrical mesh.
[0012] In some embodiments of the connector, a second end of the
mechanism comprises a generally spherical connector. In some
embodiments, the second end of the mechanism resides in a cavity
within the anchor. In some embodiments the cavity is elongated. In
some embodiments, the first end of the mechanism comprises a
generally spherical connector.
[0013] In some embodiments, a cavity is within the anchor, wherein
the first end of the mechanism can reside. In some embodiments, the
implantable device comprises a second end of the mechanism which
comprises a generally spherical connector. In some embodiments, the
second end of the mechanism resides in a cavity within the valve.
In some embodiments, at least one of the cavities is elongated.
[0014] Another aspect of an embodiment is an implantable device for
deployment in an anatomical lumen wherein the device comprises an
occluding device and an articulable anchor for securing the
occluding device within the lumen in a manner that permits the
anchor to articulate substantially with respect to said occluding
device. The articulable anchor comprises a mechanism connecting
said anchor to the occluding device. Additionally, the mechanism
comprises at least one connector at a first end to connect said
mechanism to at least one anchoring member and the articulable
anchor includes a cavity.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a perspective view of an implantable device with a
one-way valve, an anchor, and a connector;
[0016] FIG. 2 is a side view of an implantable device with an
articulable anchor.
[0017] FIG. 3 is a cross-sectional view of the device of FIG.
2.
[0018] FIG. 4 is a cross-sectional view of an air passageway and an
implantable device with an articulable anchor that spans a
bifurcated air passageway;
[0019] FIG. 5 is a cross-sectional view of an implantable device
with an articulable anchor in accordance with another
embodiment;
[0020] FIG. 6 is a cross-sectional view of an implantable device
with an articulable anchor in accordance with another
embodiment;
[0021] FIG. 7 is a side view of an implantable device with an
articulable anchor in accordance with another embodiment;
[0022] FIG. 8 is a side view of a flexible connector for use in an
implantable device with an articulable anchor;
[0023] FIG. 9 is a side view of an implantable device with an
articulable anchor having a biasing member and a connector
positioned between an obstruction member and the anchor system;
[0024] FIGS. 10A-10C are side views of alternative embodiments of
frames for implantable devices with articulable members embodied as
flexible connectors; and
[0025] FIG. 11 is a cross-sectional view of an air passageway and a
flexible implantable device positioned in the air passageway
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0026] FIG. 1 illustrates an implantable device in an expanded
position. The implantable device 10 is configured to affect airflow
in an air passageway in a lung. The implantable device comprises an
anchor 12 and an obstruction member 14. A connecting mechanism 16
couples the anchor 12 to the obstruction member 14. The illustrated
implantable device 10 includes a support structure 18 that can form
the frame of the implantable device 10. At least a portion of the
anchor 12, the connecting mechanism 16, and the obstruction member
14 can be formed by the support structure 18. An elongated member
20 extends axially through obstruction member 14 and can be
directly or indirectly coupled to the support structure 18.
[0027] The obstruction member 14 surrounds at least a portion of
the elongated member 20 and is configured to interact with an
anatomical lumen, such as an air passageway, to regulate the flow
of fluid through the lumen. The obstruction member 14 can
effectively function as a one-way valve. One example of an
obstruction member is an occluding device.
[0028] The anchor 12 comprises a plurality of anchor members 22
that extend from the connecting mechanism 16. In the illustrated
embodiment, each of the anchor members 22 is an elongated member
that extends radially outward from the connecting mechanism 16 and
terminates at a piercing end 24, although the anchor members 22 can
have any number of piercing ends. One or more stops 26 can be
positioned along each anchor member 22, preferably positioned at
some point near the piercing members 24. The stops 26 can be
configured to limit the puncturing by the piercing member 24
through lung tissue beyond a desired depth.
[0029] The stops 26 can be formed by splitting the distal ends of
the anchor members 22. One of the split sections can be bent
downwardly to form the stop 26, while leaving the second split
section to extend outwardly to form the piercing member 24.
Although the stops 26 can be formed integrally with the anchor
member 22, the stops 26 can also be applied in a subsequent
process. For example, each stop 26 can be a piece of metal that is
mounted to the anchor members 22. Thus, each of the anchor members
22 can be of a one piece or multi-piece construction.
[0030] Any number of anchor members 22 can be used to limit
migration of the implantable device 10 implanted at a desired
deployment site. The illustrated implantable device 10 comprises
five anchor members 22 that are coupled to the connecting mechanism
16. However, the anchor 12 can comprise any suitable number of
anchor members in any various configurations. A skilled artisan can
select the number of anchor members 22 based on the size of an air
passageway, anchor design, and the like. The anchor members 22 can
be positioned at regular or irregular intervals. When the anchor 12
is positioned in situ, the piercing members 24 can engage tissue of
an air passageway wall of a lung to retain the implantable device
10 at a desired location. One non-limiting example of such an
engagement occurs when at least one piercing member punctures the
wall of the air passageway.
[0031] With continued reference to FIG. 1, the obstruction member
14 is generally umbrella-shaped and comprises an obstructing member
frame 28 that carries a membrane 32. The obstructing frame 28
includes a plurality of arcuate struts 30 that support the membrane
32.
[0032] A plurality of pathways can be defined by the obstruction
member 14 between each pair of struts 30. When the implantable
device 10 is securely anchored in a lung passageway, the struts 30
can bias the obstruction member 14 outwardly against the air
passageway wall. Between each pair of struts 30, the membrane 32
can define the pathway that permits mucus transport past the
obstruction member 14 through the associated air passageway.
[0033] Proper mucociliary functioning can be maintained to ensure
that the respiratory system continues to self clean after an
implantable device has been deployed. To maintain mucociliary
transport the membrane 32 can be folded inwardly away from the air
passageway wall, especially during exhalation when the implantable
device 10 has the anchor 12 positioned distally. The membrane 32
can press lightly against the air passageway wall in order to
permit cilliary action for the movement of mucus past the membrane
32. Of course, the implantable device can have other configurations
that permit mucus transport.
[0034] The membrane 32 can be treated to enhance sealing, improve
biostability, and/or enhance mucus transport. To enhance valving
action, the membrane 32 can be treated with a material that
interacts with a wall of an air passageway to improve functioning.
A coating on the membrane can reduce airflow in at least one
direction between the air passageway and the expanded membrane
engaging the air passageway wall. The coating can be a hydrogel
that helps the membrane 32 adhere to the air passageway wall to
further limit air flow past the implantable device in at least one
direction. Other coating materials can be applied to the membrane
or other portions of the implantable device depending on the
intended application. The coating can be applied before, during, or
after the implantable device is placed in a passageway.
[0035] In some embodiments, the membrane 32 can be coated with a
lubricious material to limit adherence to an air passageway.
Additionally, an implantable device may partially or fully collapse
when subjected to rapid pressure changes, such as when a person
coughs. If the membrane is folded together, the lubricious material
can inhibit sticking of the membrane to itself so that the
implantable device can quickly re-expand to function effectively
again.
[0036] The implantable device can be adapted to facilitated
movement through a delivery lumen. To reduce frictional forces
between the implantable device and a lumen of a delivery
instrument, a release agent can be applied to the implantable
device. The release agent can reduce the force required to eject
the implantable device out of the lumen as detailed above.
[0037] The struts can have first strut ends connected to the
connecting mechanism 16 and opposing second strut ends. The
proximal tips of the struts can curve radially inward toward the
longitudinal axis of the implantable device 10.
[0038] With continued reference to FIG. 1, the elongated member 20
comprises a rod 34 that is connected to the connecting mechanism 16
and a gripping head 36. The rod 34 is a generally cylindrical body
that extends along the longitudinal axis of the implantable device
10, although the rod 34 can be at other suitable locations. For
example, the rod 34 can be angled or offset from the longitudinal
axial of the implantable device 10.
[0039] The rod 34 is connected to the gripping head 36 that is
positioned exterior to the chamber defined by the membrane 32. The
rod 34 extends from the opening such that the gripping head 36 is
spaced outwardly from the opening defined by the membrane 32. The
elongated member 20 can be of such a length that it extends beyond
the second end of the struts when the implantable 10 occupies an
expanded position. When the gripping head 36 is spaced from the
proximal ends of the struts and the membrane 32, a removal device
(not shown) can easily grip the exposed gripping head 36. In
alternative embodiments, the rod 34 terminates to form the gripping
head 36 positioned inwardly of the opening defined by the member
32. Other embodiments of the gripping head 36 can include various
changes in shape and size of the gripping head 36 to cooperate with
different coupling mechanisms.
[0040] The elongated member 20 can also be of such a length that
the elongated member 20 and the struts 30 extend substantially the
same distance from the connecting mechanism 16 when the implantable
device 10 is in a fully collapsed state (not shown). The struts 30
can lie flat along the rod 34 for a low profile configuration. The
gripping head 36 preferably remains exposed so that the implantable
device 10 can be pushed out of a delivery instrument by
conveniently applying a force to the gripping head 36.
[0041] A variety of removal devices can be used to engage the
implantable device to, for example, reposition, re-implant, or
remove the implantable device as discussed above. The enlarged
gripping head 36 can be designed to facilitate removal of the
implantable device 10 by any of numerous extracting devices and
methods as are known in the art. The removal gripping head 36 can
be gripped by a removal device (such as forceps, an extractor, a
retractor, gripping device, or other suitable device for gripping a
portion of the implantable device 10). A sufficient proximal force
can be applied to displace the implanted implantable device 10 from
the implantation site. The illustrated gripping head 36 is a
somewhat cylindrical knob having an outer diameter that is greater
than the outer diameter of the rod 34. The gripping head 36 can
have other configurations for engaging a removal device. Exemplary
gripping heads can comprise a hook, ring, enlarged portion,
connectors (e.g., snap connector, threaded connector, etc), or
other structure for permanently or temporarily coupling to a
removal device.
[0042] FIG. 2 is a side view of an embodiment of an implantable
device 50. The obstruction member 58 is coupled with the anchor 56
by a connecting mechanism 52. In the illustrated embodiment, the
connecting mechanism 52 comprises a connecting member 54. The
connecting mechanism 52 permits articulation between the
obstruction member 58 and the anchor 56. In the illustrated
position, the obstruction member 58 and the anchor 56 are collinear
along the longitudinal axis of the implantable device 50. Through
articulation of the connecting mechanism 52, the obstruction member
58 and the anchor 56 can be configured to no longer be collinear
along the longitudinal axis of the implantable device 50. As one
non-limiting example, the obstruction member 58 can be maintained
at an unaltered orientation while the connecting mechanism 52,
either by pivoting or flexing, can continue to couple the
obstruction member 58 to the anchor 56 while the anchor 56 is moved
to a different orientation than that of the obstruction member 58.
In some embodiments, the connecting mechanism 52 can permit axial
movement, changing the distance between the distal end of the
obstruction member 58 and the proximal end of the anchor 56. In
some embodiments, the articulation of the connecting mechanism 52
is accomplished through discrete pivotal orientation changes. In
other embodiments, the connecting mechanism 52 is configured to
articulate through continuous flexing, such as the bending of a
flexible member. In still other embodiments, the connecting
mechanism 52 can be configured to permit changes in orientation
between the obstruction member 58 and the anchor 56 by limiting
separation between the obstruction member 58 and the anchor 56 when
the connecting mechanism 52 is not rigidly coupled to the two
components. In these embodiments, the connecting mechanism 52 can
comprise a tether or other limiting component.
[0043] FIG. 3 is a cross-sectional view of another embodiment of an
implantable device 100. The implantable device 100 is configured to
permit an angled position. The implantable device 100 can be
positioned in a naturally angled air passageway (e.g., a bifurcated
air passageway, tortuous air passageway, etc.) in a lung. The
implantable device 100 has an anchor sufficiently articulable so as
to permit deployment of the implantable device 100 within the
angled air passageway without substantially altering the natural
geometry of the air passageway. The implantable device 100 can
effectively function even though the obstructing member 102
conforms to the natural shape of the air passageway. The
implantable device 100 can be generally similar to the implantable
device 10 of FIG. 1, and accordingly, the following description of
the implantable device 100 can equally apply to the implantable
devices described below, unless indicated otherwise.
[0044] As used herein, the term "implantable device" is a broad
term and is used in its ordinary meaning and includes, without
limitation, articulated implantable devices, actuatable implantable
devices, and other implantable devices that have one or more means
for providing articulation, actuating, or flexibility between an
anchor and a functional member, such as an obstruction member. The
implantable devices may have any number of pivot points or flexible
portions. These implantable devices can be placed along tortuous
pathways, such as a section of a lung passageway that is
substantially curved along its length. Some embodiments include a
means for providing flexibility that comprises any combination of a
biasing member, a flexible member, a ball and socket arrangement, a
joint, a linkage, a hinge, and/or a flexible connector. As such,
the flexible implantable device can be selectively curved or angled
along its length to match the shape of the air passageway.
[0045] The illustrated implantable device 100 comprises an
obstructing member 102 articulably and pivotally connected to an
anchor system 104. The anchor system 104 can be moved relative to
the obstructing member 102 to a desired position depending on the
functional application of the device 100. An articulating
connecting portion 106 connects and permits movement between the
obstructing member 102 and the anchor system 104. The articulating
connecting portion 106 permits articulation of the device 100 such
that the device 100 can be implanted in curved air passageways
without significantly altering the natural geometry of the air
passageway. For example, the implantable device 100 can span a
bronchial branching section of a lung. The implantable device 100
can be articulated repeatedly (e.g., during normal lung
functioning) without appreciable trauma to the lung, or to the
implantable device 100. Traditional stent-based devices for
implantation in air passageways are typically rigid elongated
structures that are not suitable for placement in bifurcated or
substantially curved air passageways. These stent-based devices
maintain their linear configuration thus rendering them unsuitable
for use in these types of air passageways.
[0046] With reference again to FIG. 3, the articulating connecting
portion 106 can have various configurations for permitting relative
movement between the anchor system 104 and the obstructing member
102. In some embodiments, including the illustrated embodiment, the
articulating connecting portion 106 comprises at least one ball and
socket arrangement. The illustrated anchor system 104 has an anchor
socket 120 comprising a generally spherical cavity that holds one
end of the connecting rod 124, while the obstructing member 102 has
an obstructing socket 122 that holds the other end of the
connecting rod 124.
[0047] The connecting rod 124 has a first end 128 and an opposing
second end 126. Each of the ends 126, 128 is generally spheroidal
and sized to be received by the corresponding socket 122, 120. The
spheroidal shape the ends 126, 128 can be integral with the
connecting rod 124 or generally spheroidal-shaped members can be
coupled to or mounted on the ends 126, 128. The first end 128 is
rotatably mounted in the obstructing socket 122. The second end 126
is rotatably mounted in the anchor socket 120. As such, the sockets
120, 122 can rotate freely about the ends of the connecting rod
124. Thus, the implantable device 100 has a plurality of joints
that permit articulation. The implantable device can have any
number of articulable connecting portions for a particular
application.
[0048] To reduce wear of the balls and the sockets, the surface(s)
of the sockets and/or ends 126, 128 can be coated with a material
to reduce frictional interaction. For example, the interior surface
130 of the anchor socket 120 can comprise one or more of the
following: a somewhat lubricious material (e.g., Teflon.RTM.),
ceramics, metals, polymers (preferably hard polymers), or
combinations thereof. However, other materials can be utilized to
limit or inhibit wear between the connecting rod 124 and the
obstructing member 102 and/or the anchor system 104. When the
implantable device 100 is deployed in the lungs, the anchor socket
120 can move, preferably slightly, with respect to the ball at the
second end 126 during normal respiration. The wear-resistant
surfaces can minimize debris build up that can impede performance
of the implantable device 100. In view of the present disclosure,
one of ordinary skill in the art can determine the appropriate
combination of materials, geometry of the ball and socket
arrangement, and the length of the connecting rod 124 to achieve
the desired positioning of the implantable device 100.
[0049] The connecting rod 124 can have a one-piece or multi-piece
construction. In some embodiments, the connecting rod body 142 and
the ends 126, 128 are formed of a single material (e.g., a metal
such as Nitinol or titanium). In other embodiments, the connecting
rod body 142 is formed of a flexible material, and the ends 126,
128 are formed of a somewhat hard, rigid material, such as a
ceramic.
[0050] The connecting rod 124 can be generally straight, as shown
in FIG. 3. However, the connecting rod 124 can have other
configurations based on clinical need. For example, the connecting
rod 124 of FIG. 8 has an angled shape that allows placement of the
implantable device in a complex shaped airway (e.g., an airway with
sharp curves, branching portions, etc.).
[0051] With continued reference to FIG. 3, an elongated member 134
includes a rod 138 having an end portion 140 that is connected to
the obstructing member frame 136. The end portion 140 can be
connected to the frame 136 by one or more mechanical fasteners,
adhesives, welding, boarding, interference fit, threads, or other
suitable coupling means for securely coupling the rod 138 to the
frame 136. In some embodiments, including the illustrated
embodiment, the rod 138 is connected to the interior portions of
the struts 110, although the rod can be connected to other portions
of the frame 136. The rod 138 can also be formed integrally with at
least a part of the frame.
[0052] As shown in FIG. 4, the implantable device 150 can be placed
at a branching air passageway of the bronchial tree. The
obstructing member 152 is within a proximal passageway 160 and the
anchor system 154 is positioned within a distal sub-branch air
passageway 162. The implantable device 150 can therefore span the
junction 164 of the air passageway of the lung and, thus, permits
flexibility in positioning of the device 150. The air passageway
can generally retain its natural shape, such as its shape before
implantation of the implantable device 150, to minimize trauma to
the lung tissue. The orientations of the implantable devices are
not limited solely to the illustrated orientations. The implantable
device 150 can be reversed from the illustrated orientation so that
the anchors are located proximally of the obstruction member. Thus,
the implantable device 150 can be oriented to permit air flow in
any desired direction.
[0053] The implantable device 150 can also be implanted in
non-branching portions of lungs. If desired, the implantable device
150 can be implanted in continuous air passageways that are
generally straight, curved, angled, or having any other
configuration. Because the implantable device 150 can assume
various configurations, there is significant flexibility in
selecting a deployment site. The implantable device 150 can also be
implanted in air passageways that have a substantially constant or
varying cross-section. Advantageously, the physician can implant
the implantable device 150 at various locations throughout the lung
to treat specific portions of the lung. If the implantable devices
are in the form of occluding devices or flow regulating devices
(e.g., a one-way valve, flow resistor, etc.), these devices can be
implanted proximally of, and adjacent to, the diseased portions of
a lung, thus maximizing the amount of healthy lung tissue that can
function, even if the diseased lung tissue is in the far distal
portions of the bronchial tree.
[0054] FIG. 5 illustrates an implantable device 200 that comprises
an anchor system 202 that is pivotally coupled to an elongated
member 204 that extends through the obstructing member 206. The
elongated member 204 has a generally spheroidal member 208 that is
rotatably mounted in an anchor socket 210 of the anchor system 202.
The obstructing member 206 can be fixedly attached at some point
along the elongated member 204.
[0055] To secure the obstructing member 206 to the elongated member
204, a portion of an obstructing member frame 212 and/or a membrane
214 can be coupled to the elongated member 204. In the illustrated
embodiment, the struts of the obstructing member frame 212 and the
membrane 214 are both coupled to the outer surface of the elongated
member 204.
[0056] Once deployed, the implantable device 200 illustrated in
FIG. 5 can be retained in place by the anchor system 202. The
implantable device 200 can be positioned in a non-linear lumen,
such as those illustrated in FIG. 4, because the anchor system 202
may remain at a first orientation while the obstructing member 206
is pivoted to a second orientation by the generally spheroidal
member 208 and the anchor socket 210. The obstructing member 206
can be configured to move axially from the anchor system 202
through travel along the elongated member 204, which can be limited
to prevent inefficient operation of the implantable device 200.
[0057] FIG. 6 is a cross-sectional view of a implantable device 250
that has an articulable connecting portion 252 that permits axial
movement between an anchor system 254 and an obstructing member
256. The connecting portion 252 includes a holder 260 of the anchor
system 254 and a holder 262 of the obstruction member 256. Each of
the holders 260, 262 is configured to receive an end of a connector
264. The illustrated connector 264 has enlarged ends that are held
by the holders 260, 262. The chambers 268, 278 of the holders 260,
262, respectively, permit axial movement of the connector 264. The
enlarged ends of the connector 264 that are held by the holders
260, 262 can also be constructed to permit pivotal movement in
addition to axial movement.
[0058] The anchor system 254 and the obstructing member 256 of the
device 250 can move freely towards and away from each other.
However, one or more biasing members (not shown) can be positioned
between the anchor system and obstructing member of the implantable
device to adjust positioning of the implantable device. The biasing
member can cooperate with the connecting portion to ensure that the
implantable device remains in a desired position.
[0059] FIG. 7 illustrates an implantable device 300 that has an
articulating connecting portion 302 that includes a flexible member
304 connected to the anchor system 306 and the obstructing member
308. The flexible member 304 can comprise a somewhat flexible
elongated member (e.g., a solid rod, a hollow tube, ribbon, etc.)
and can comprise metal, polymers (preferably a somewhat rigid
polymer), filaments, and the like. The flexible member 304
preferably does not substantially stretch or buckle when an axial
force is applied thereto. Alternatively, the flexible member 304
can be configured to allow significant axial movement between the
anchor system 306 and the obstructing member 308. The flexible
member 304 can be, for example, a tether that holds together and
limits the axial movement of the anchor system 306 away from the
obstructing member 308. However, the flexible member 304 may be
easily collapsed as the anchor system 306 is moved towards the
obstructing member 308. The flexible member 304 can comprise a
rope, wire, filaments, or other suitable member for providing
relative movement between the anchor system 306 and the obstructing
member 308.
[0060] With reference to FIG. 8, the connecting rod 350 can have or
bend to have an angled central portion 352 that defines an angle
.theta.. The length L1 and L2 can be selected to achieve the
desired orientation and size of an implantable device. If the
implantable device is deployed at a sharp bend of an air
passageway, the angle .theta. can be matched with the angle of the
bend to generally align the longitudinal axis of an anchor system
with one of the passages and the longitudinal axis of an
obstructing member with the other passage. The implantable device,
for example, can include a connecting rod for deployment in air
passageways that together form an acute angle. Accordingly, the
configuration of the connecting rod 350 can be selected based on
the target deployment site.
[0061] As illustrated in FIG. 9, the implantable device 400 can
have a biasing member 402 positioned between an obstructing member
404 and an anchor system 406. One example of such a biasing member
is a helical spring. In the illustrated embodiment, a tether 408
extends through the biasing member 402 between the obstructing
member 404 and the anchor system 406. Other embodiments can have a
tether 408 connecting the obstructing member 404 and an anchor
system 406 that does not extend through the biasing member 402 and
instead passes at least partially outside the biasing member 402.
Alternatively, a flexible cylindrical member (not shown) can extend
between the obstructing member 404 and the anchor system 406,
substantially completely enclosing the biasing member 402. The
tether can also be a connector such as the one illustrated in FIG.
7.
[0062] FIGS. 10A-10C illustrate various embodiments of support
frames of implantable devices, each having a means for flexing.
Each of the support frames has a flexible connecting portion that
permits relative movement between an anchor system and an
obstructing member frame. The frames as illustrated do not have
membranes; however, any of various types of membranes can be
applied to the obstructing member frames. FIG. 10A illustrates a
frame support 450A that includes a flexible connecting portion 452A
in the form of slots in an alternating pattern. The connecting
portion 452A can be an integral piece with the frame, as
illustrated, or can be coupled or mounted to an anchor system 454A
and an obstruction frame 456A. The flexible connecting portion 452A
can be formed by cutting slots out of a tube. The number and size
of the slots can be selected to achieve the desired flexibility.
Additionally, the material used to construct the connecting portion
can be selected for its flexibility characteristics.
[0063] FIG. 10B illustrates a frame support 500B that is generally
similar to the frame support 450A of FIG. 10A. In the illustrated
embodiment, the frame support 500B includes a flexible connecting
portion 502B in the form of a spring member extending axially along
the longitudinal axis of the frame support 500B. As such, the
spring member can be arranged in a spiral fashion about the
longitudinal axis of the flexible connecting portion 502B. The
illustrated spring member is in the form of a helical spring,
although other types of springs or resilient members can be
utilized. The spring can comprise the connecting member alone or
can act as a biasing member, as described above. Additionally, as
described above, the spring can be formed integrally with the
frame, or serve as a coupler for both an anchor system and
obstruction frame.
[0064] FIG. 10C illustrates a frame support 550C that comprises a
flexible connecting portion 552C comprising a mesh. The connecting
portion 552C can comprise a mesh of various sizes, with large or
small mesh spaces. Additionally, the mesh can be constructed of a
variety of materials, such as metals, synthetics, or any other
resilient material. The mesh can permit flexing, as when the
obstructing frame 554C and anchor system 556C are positioned at
different orientations, as described above. In some embodiments,
the mesh can also permit axial compression along the longitudinal
axis of the frame support 550C. As described, the mesh can be
formed integrally with the frame, or be mounted or coupled at
either end to the obstructing frame 554C and anchor system
556C.
[0065] The illustrated struts 600A, 600B, 600C of FIGS. 10A-10C
each have two generally elongated straight portions connected by a
bend. The struts 600A, 600B, 600C can also have a continuously
curved configuration similar to the struts described above. The
frame supports can carry a membrane to form an obstructing member,
such as an obstructing member adapted to function as a valve
(preferably a one-way valve). The connecting portions can enhance
the seating of the obstructing member within an air passageway to
enhance valve functioning.
[0066] With reference to FIG. 11, an implantable device 700 is
illustrated as having a flexible connecting portion 702, such as
the one shown in FIG. 10A. The implantable device 700 is deployed
and implanted in an air passageway 708 and is held in place by its
anchor system 704. The flexible connecting position 702 can apply a
force to the obstructing member 706 of the implantable device 700
to enhance seating between the membrane of the obstructing member
706 and the wall 708. Thus, a bias of the flexible connecting
portion 702 can ensure that an effective seal is maintained between
the obstructing member 706 and the wall 708, thereby limiting or
preventing the flow of air distally past the implantable device
700. Advantageously, the implantable device 700 can permit the
passage of air proximally past the obstructing member 706 when the
pressure differential across the implantable device 700 is
sufficiently high. As the air flows proximally past the obstructing
member 706, the flexible connecting portion 702 can apply a
distally directed force. When the pressure differential is reduced
a sufficient amount, the obstructing member 706 is pulled distally
against the air passageway wall 708 to once again form a seal with
the air passageway wall. Thus, the obstructing member 706 can move
slightly during normal lung functioning while the anchor system 704
can remain securely fixed in place. The flexible connecting portion
702 can therefore enhance the valving action of the implantable
device 700.
[0067] If desired, the connecting portion 702 can also be used to
position the anchors 704 and the obstructing member 706 along a
tortuous path within a lung, as shown in FIG. 4 above. The
connecting portion 702 can be positioned along sharp turns that may
be unsuitable for rigid valves, such as stent-based devices.
[0068] All patents and publications mentioned herein are hereby
incorporated by reference in their entireties. Except as further
described herein, the embodiments, features, systems, devices,
materials, methods and techniques described herein may, in some
embodiments, be similar to any one or more of the embodiments,
features, systems, devices, materials, methods and techniques
described in U.S. patent application Ser. No. 10/409,785 (U.S.
Publication 2004-0200484), filed Apr. 8, 2003; Ser. No. 09/951,105
(U.S. Publication No. 2003/0050648A1), filed Mar. 13, 2003; Ser.
No. 10/848,571, filed May 17, 2004; Ser. No. 10/847,554, filed May
17, 2004; Ser. No. 10/418,929, filed Apr. 17, 2003; Ser. No.
10/081,712 (U.S. Publication 2002-0112729), filed Feb. 21, 2002;
Ser. No. 10/178,073 (U.S. Publication 2003-0154988), filed Jun. 21,
2002; Ser. No. 10/317,667 (U.S. Publication 2003-0158515), filed
Dec. 11, 2002; Ser. No. 10/103,487 (U.S. Publication 2003-0181922),
filed Mar. 20, 2002; Ser. No. 10/124,790 (U.S. Publication
2003-0195385), filed Apr. 16, 2002; Ser. No. 10/143,353 (U.S.
Publication 2003-0212412), filed Mar. 9, 2002; Ser. No. 10/150,547
(U.S. Publication 2003/0216769), filed May 17, 2002; Ser. No.
10/196,513 (U.S. Publication 2004-0010209), filed Jul. 15, 2002;
Ser. No. 10/254,392 (U.S. Publication 2004//0059263), filed Sep.
24, 2002; Ser. No. 10/387,963 (U.S. Publication 2004-0210248),
filed Mar. 12, 2003; Ser. No. 10/745,401, filed Dec. 22, 2003; U.S.
Pat. Nos. 6,293,951; 6,258,100; 6722360; 6,592,594, which are
hereby incorporated herein and made part of this specification. In
addition, the embodiments, features, systems, devices, materials,
methods and techniques described herein may, in certain
embodiments, be applied to or used in connection with any one or
more of the embodiments, features, systems, devices, materials,
methods and techniques disclosed in the above-mentioned
incorporated applications and patents.
[0069] The articles disclosed herein may be formed through any
suitable means. The various methods and techniques described above
provide a number of ways to carry out the invention. Of course, it
is to be understood that not necessarily all objectives or
advantages described may be achieved in accordance with any
particular embodiment described herein. Thus, for example, those
skilled in the art will recognize that the methods may be performed
in a manner that achieves or optimizes one advantage or group of
advantages as taught herein without necessarily achieving other
objectives or advantages as may be taught or suggested herein.
[0070] Furthermore, the skilled artisan will recognize the
interchangeability of various features from different embodiments
disclosed herein. Similarly, the various features and steps
discussed above, as well as other known equivalents for each such
feature or step, can be mixed and matched by one of ordinary skill
in this art to perform methods in accordance with principles
described herein. Additionally, the methods which are described and
illustrated herein are not limited to the exact sequence of acts
described, nor are they necessarily limited to the practice of all
of the acts set forth. Other sequences of events or acts, or less
than all of the events, or simultaneous occurrence of the events,
may be utilized in practicing the embodiments of the invention.
[0071] Although the invention has been disclosed in the context of
certain embodiments and examples, it will be understood by those
skilled in the art that the invention extends beyond the
specifically disclosed embodiments to other alternative embodiments
and/or uses and obvious modifications and equivalents thereof.
Accordingly, the invention is not intended to be limited by the
specific disclosures of preferred embodiments herein.
* * * * *