Note: Descriptions are shown in the official language in which they were submitted.
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DEVICES AND METHODS FOR LUNG VOLUME REDUCTION
CROSS-REFERENCE TO RELATED APPLICATIONS
[001] This application claims the priority of the following applications, the
disclosures of which are
incorporated by reference herein: U.S. Provisional Application No. 61/845,355,
filed July 11, 2013;
U.S. Provisional Application No. 61/846,992, filed July 16, 2013; U.S.
Provisional Application No.
61/856,227, filed July 19, 2013; U.S. Provisional Application No. 61/906,711,
filed November 20,
2013; U.S. Provisional Application No. 61/914,330, filed December 10, 2013;
U.S. Provisional
Application No. 61/921,070, filed December 26, 2013; and U.S. Provisional
Application No.
61/934,638, filed January 31, 2014
[002] This application incorporates by reference herein the disclosure of U.S.
Provisional Application
No. 61/938,352, filed February 11,2014.
INCORPORATION BY REFERENCE
[003] All publications and patent applications mentioned in this specification
are herein incorporated by
reference to the same extent as if each individual publication or patent
application was specifically
and individually indicated to be incorporated by reference.
BACKGROUND OF THE DISCLOSURE
[004] Lung volume reduction (LVR) is an important procedure in the treatment
of emphysema or
chronic bronchitis, a form of Chronic Obstructive Pulmonary Disease (COPD).
COPD is the third
leading cause of death in the United States. Emphysema is a type of COPD
involving damage to the
air sacs (alveoli) in the lungs. As it worsens, emphysema turns the alveoli
into large, irregular pockets
with gaping holes in their inner walls. This reduces the surface area of the
lungs and, in turn, the
amount of oxygen that reaches the bloodstream during each breadth. The damaged
lung tissue
additionally loses its ability to hold its normal shape and becomes hyper-
inflated, thereby consuming
a larger volume than comparable healthy tissue. Emphysema also slowly destroys
the elastic fibers
that hold open the small airways leading to the air sacs. This allows these
airways to collapse upon
exhalation, trapping air in the lungs. Treatment may slow the progression of
emphysema, but it can't
reverse the damage. The disclosure described herein comprise minimally
invasive treatments intended
to bring relief to patients suffering from the stages of emphysema where
diseased portions of the lung
no longer efficiently contribute to the oxygenation of the blood, but instead
provide a hindrance to
lung function and capacity.
[005] Emphysema is often classified as to how uniformly diseased tissue or how
uniformly the diseased
state of the tissue is distributed through the lung. The two extremes are
heterogeneous, where there
are distinct pockets of diseased tissue separated by healthier tissue, and
homogeneous, where the
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distribution of the diseased state of the tissue is more uniform. When there
is a heterogeneous
presentation it is useful to reduce the volume of the most diseased area of a
lung. When the
presentation is homogeneous it is useful to treat a portion of the most
diseased lobe of the lung.
SUMMARY OF THE DISCLOSURE
[006] The disclosure described herein relates to apparatuses and methods which
provide for minimally
invasive treatment via LVR in patients suffering from emphysema by providing
mechanical
compression of the emphysematous tissue. This compression serves to reduce the
volume occupied
by the emphysematous tissue. Additionally, the compression of diseased tissue
restores some of the
lost compliance or elasticity of the original tissue and allows for the distal
airways to remain open
during exhalation, thereby allowing the release of trapped gas from within the
healthy tissue. This
procedure provides the benefits of surgical lung volume reduction while
minimizing the risks
associated with the far more invasive surgical procedure.
[007] The apparatus of this disclosure comprises an anchoring system which in
turn comprises at least
two anchors connected to one another by a tethering structure, the system
configured such that the
distance between the two anchors can be decreased. In some embodiments the two
anchors are
comprised of at least a proximal anchor, at least a distal anchor, the at
least one distal anchor and the
at least one proximal anchor connected to one another by a tether, and a
mechanism to decrease the
distance between the proximal and distal anchors. In some embodiments there
will be more than one
distal anchors connected to a proximal anchor. In an alternate embodiment, the
two anchors will be
distal anchors and the proximal anchor will be the interface between the
tether and a bifurcation in the
bronchi. In many embodiments the distal anchor will be a fixation anchor
designed to affix to the
surrounding tissue, typically the wall of an airway, and in some cases
additionally the tissues
surrounding the airway.
[008] In some embodiments the distance between two anchors may be adjusted by
shortening the tether,
in others by reducing the amount of tether between the two anchors. For the
purposes of discussions
herein foreshortening will describe either means of reducing the distance
between anchors spanned by
a tether. In some preferred embodiments the distance between an at least one
proximal and one or
more distal anchor(s) is adjustable such that the distance may be increased,
or decreased. Yet other
anchor embodiments allow for the release of the tether completely. A number of
embodiments
described in which the tether is shortened follow. The proximal anchor
comprises a way of twisting
the tether on itself such that the tether winds on itself, thereby
foreshortening. The tether comprises a
spring which on deployment shortens. Some embodiment in which the distance
between two anchors
is reduced by reducing the length of tether between two anchors are as
follows. The proximal anchor
comprises a means of winding the tether onto a spool. The tether is pulled
through a catch
mechanism comprised in the anchor. Additionally the tether comprises a feature
which interfaces
with the catch mechanism. The tether is comprised of a material which can be
caused to shrink, such
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as by denaturation resulting from heating or a pH change, after deployment.
Twisting or spooling of
the tether and thereby managing any and all excess tether length that may
result from the tensioning
and foreshortening of the tether on implementing a lung volume reduction
reduces the likelihood of
the anchoring system causing an inflammatory response within the lung. Once
the volume of the lung
is reduced in the desired area, the remaining portion of the lung continues to
function. This dynamic
motion could exacerbate any local damage or inflammatory response that excess
tether or protruding
features may cause.
[009] As used herein a fixation anchor is a device which is designed to be
affixed to an airway. Such
anchors comprise a fixation mechanism which fixes the anchor to the airway
wall. In some
embodiments the fixation means is a mechanical means where fixation results
from a mechanical
interference with the airway wall. Mechanical embodiments may pierce the
airway wall, rely on local
expansion of the airway, rely on the branching characteristic of the airways,
rely on the alveolar
interface at the terminus of the airways. In alternate embodiments the
fixation may be by adhesive
means, and in others it use combinations of the above.
[010] Some embodiments presented herein use a spike as fixation means. The
spike is incorporated into
the anchor such that, when deployed, tensions applied to the spike by the
anchoring system, as a distal
and proximal anchor are drawn together, will drive the spike into, and
maintain the spike in, the
airway wall. In such embodiments the spikes may be configured such that upon
release form a
delivery device the spikes will move from a delivery configuration, in which
the spikes are directed at
an angle roughly along the longitudinal axis of the anchor, to a delivered
configuration in which the
spikes are directed at least partially radially outward. In other embodiments
the spikes may be
maintained in the delivery configuration by a removable wire or tab which is
removed at the time of
deployment. Such embodiments comprise an actuable fixation means. In some
embodiments the
spikes may be barbed such that once the tip passes through the airway wall the
barb inhibits the
ability of the airway wall to slip off the spike. In yet other embodiments the
distal fixation means
may comprise the whole anchor. Such an embodiment is comprised in a tagging
fastener where the
end of the tether comprises the fixation anchor. In a tagging fastener the
fixation anchor portion of
the tether is "T" shaped. During deployment the top of the "T" is folded
parallel to the stem of the
"T" and is passed through the wall of an airway. After passing the end through
the airway wall it
relaxes into its deployed state where it takes the shape of the "T". The top
of the "T" now locking the
tether to the airway. In some embodiments the tether may be terminated by a
volume of porous
material which is saturated by an adhesive delivered via a lumen in the
tether.
[011] In alternate embodiments the fixation means is purely mechanical in
nature, where the airway
wall is not breached by the fixation means. Such embodiments comprise any of
the following.
Expanding structures such as spiral springs which expand the airway wall to a
point where the
structure is unable to slip. An anchor comprised of an array of interconnected
distal airways filled
with an adhesive or expanding material such as a PMMA or a collagen plug.
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[012] In some embodiments each proximal anchor will connect to one distal
anchor. In others, each
proximal anchor will connect with one distal anchor. In yet other embodiments
the anchoring features
will be distributed along the entire extent of the anchoring structure.
[013] In some embodiments the proximal anchors will be placed in tissue less
diseased than that in
which the distal anchors are placed. Such an embodiment will be particularly
useful in treating a
more heterogeneous presentation of the disease. In other embodiments the
distal anchors will be
placed in tissues at the borders of diseased tissue also useful in treating a
more heterogeneous
presentation. In other embodiments the anchors will be placed in airways
surrounded by tissues of a
relatively uniform disease state such as in a homogeneous presentation where
the tissues of a
particular lobe are of a relatively uniform diseased state, but the particular
lobe is more diseased the
other lobes of the lung.
[014] In some embodiments of this disclosure the anchors will be drawn
together in a sequential
fashion. Such a sequential foreshortening minimizes stress gradients across
the volume reduced
tissue both during the procedure and after completion of the procedure thereby
reducing the risk of
tears arising in the tissue and resultant loss in the total volume reduction.
In a sequential procedure
multiple anchor systems and or anchors within an anchor system will be
foreshortened in an
incremental fashion. Each tether will be foreshortened incrementally by an
amount less than the total
expected for the end LVR. In this way each tether will be foreshortened
multiple times during the
procedure. Alternatively, sequential may mean foreshortening one tether at a
time.
[015] In some instances such as when treating heterogeneous emphysematous
tissue where some
anchors can be placed in the peripheral healthier tissue at the borders of the
more diseased tissue, and
others are placed within more diseased tissues, the sequential procedure will
allow the peripheral
anchors to be drawn up first followed by those in the less healthy tissue. In
such a situation it can be
desirable to draw in the boundary tissues more than the central anchors to
start. As the healthier
tissue compresses in on the less healthy tissue less force will be required to
draw in the less healthy
tissue thereby reducing the risks of tears in the tissue. In situations where
the tissue is of more
uniform quality, adjusting each anchor by a consistent amount and cycling
through all of the anchors
multiple times will be more advantageous. In any procedure if tears are
observed either by imaging
or other means to be described, the foreshortening of individual anchors can
be reversed relieving the
stress gradients across the tissue. In such situations additional anchors may
also be placed. Such a
procedure is facilitated when performed under Fluoro or other medical imaging
system.
[016] Prior to any procedure a pre-evaluation can be performed to facilitate
the eventual procedure.
Such a pre evaluation can comprise any of the following procedures. Imaging
procedures such as CT,
standard Xray, Fluoroscopy (Fluoro), MRI, or ultrasound. Functional
evaluations such as FEV1, RV,
FVC, TLC, or other lung function test. Additionally tests which provide
insights into the compliance,
both dynamic and static, and or density distribution of the lung tissue will
be useful. For the purpose
of characterizing density and compliance an intrabronchial ultrasound will be
useful.
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[017] After the pre-procedure evaluations are concluded a planning step will
be performed. Such a step
may be performed at the time of the LVR procedure and incorporate additional
evaluations or it may
be performed prior to the LVR procedure. The planning step will comprise some
combination of the
following. The identification of regions to be treated based on, density and
or compliance as
determined by medical imaging. An intrabronchial ultrasound can be
particularly useful in such
determinations, especially when preformed during the procedure. The
identification of boundary
between emphysematous and normal tissue using any of the techniques described
herein. A
determination of the number of and location of devices to be placed within and
around or at the
boundary of the emphysematous tissue. A determination of an initial goal for
amount of tissue
reduction predicated on any of the evaluations described herein.
[018] A stepwise reduction may be performed in addition to or in combination
with sequential
reduction. In a stepwise reduction a period of time is allowed to pass prior
to each incremental
reduction, where each incremental reduction may comprise a foreshortening of
all tethers or some
subset of all of the tethers. A stepwise reduction may comprise any
combination of the following. A
stepwise reduction predicated on a healing response. Such a procedure would
incorporate some
combination of the following steps. Implant a set of anchors then apply
coordinated sequential
loading, load or displacement, to each anchor. The target magnitude of the
loading or displacement
increments characterized by any of the evaluations performed previously or
elsewhere herein. The
amount of displacement or loading applied determined using flouro, force
measurements or torque
measurements. Allow for tissue stabilization for a period of 5 minutes to 3
months (or more such as
out to one or more years) depending on the magnitude of the healing response
desired. Repeat the
process until the desired LVR is achieved.
[019] Alternatively or in combination the stepwise procedure may be predicated
on allowing for an
initial ingrowth / fixation of the anchors. Such a procedure would comprise
some combination of the
following steps. Implant anchors and allow tissue ingrowth to stabilize for a
period of 7 days to 3
months. Then apply coordinated sequential loading load or displacement to each
anchor. The target
magnitude of the loading or displacement increments characterized by any of
the evaluations
performed previously. The amount of displacement or loading applied determined
using flouro, force
measurements or torque measurements. Allow for tissue stabilization for a
period of 5 minutes to 3
months (or more such as out to one or more years) depending on the magnitude
of the healing
response desired. Repeat the process until the desired LVR is achieved. The
process can be repeated
until the desired outcome is achieved. In some circumstances adjustments may
be repeated at time
periods of one year or more to accommodate further deterioration of the
emphysematous condition.
[020] In some embodiments the device is implanted but lung volume is not
immediately reduced. This
can be done to allow initial ingrowth/fixation as discussed herein with risk
of tearing of tissue.
Methods of reducing lung volume can therefor include endobronchially
delivering an anchoring
device to a location within the lung within a delivery device, the anchoring
device comprising a distal
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anchor, a proximal anchor, and a tether extending between the distal and
proximal anchors, the device
configured such that the distance between the distal and proximal anchors
measured along the tether
can be increased or decreased and then maintained after release of the
anchoring device from a
delivery device, deploying the anchoring device completely out of the delivery
device, and removing
the delivery device from the lung without increasing or decreasing the
distance between the proximal
and distal anchors. After a period of time that has sufficiently allowed
fixation or ingrowth, the lung
volume is then reduced.
[021] In stepwise and sequential procedures the number reductions can be
predicated on the pre
evaluation and or pre procedure data. Procedure planning and pre-
characterization of tissue quality
can improve procedure outcome and is an important part of such procedures.
[022] Some of the procedures described herein are facilitated by apparatus
comprising some
combination of the following. A flexible multi-lumen catheter suitable for use
in an airway.
Catheters comprising balloons or multiple balloons which may be used as
temporary or permanent
anchoring devices. Balloons which are permeable and allow for an adhesive to
permeate through the
balloon wall. Medical grade tissue adhesives or bio adhesives for use in
fixing anchoring components.
Space filling bio-materials such as gels and solids such as epoxies. Catheters
comprising a means for
penetrating the airway wall such as a directable hypo-tube capable of piercing
the wall of an airway
and delivering a mechanical anchor to a target area, and or delivering an
adhesive or space filling
material to a target area. Catheters comprising optical means such as a
flexible fiber-optic fiber or
LED capable of light by which the adhesive may be cured and other means for
curing adhesives and
space filling materials. In some embodiments a flexible fiber-optic tube
capable of delivering both a
light-curable adhesive and the light by which the adhesive may be cured may be
used. A flexible
catheter and balloon system capable of delivering an adhesive and providing a
specified vacuum force
to a target area. Such systems capable of releasing the implant portions of
any anchoring system.
[023] Some of the apparatus may additionally comprise devices capable of
performing diagnostics such
as the following. An intra-bronchial ultrasound transducer for use in
characterizing density or
compliance of local tissue. Alternatively, electrodes may be provided to allow
for electrical
impedance (El) measurements as a way of characterizing tissue electrical
impedance as a function of
hyper inflated state and or changes in tissue electrical impedance as a
function of tissue compression
arising from the lung volume reduction. In other embodiments electrical
impedance changes between
multiple anchors may be used to indicate appropriate compression or tearing of
tissues between the
multiple anchors. In these embodiments the methods can include endobronchially
positioning a tissue
characterizing device within the lung, activating the characterizing device at
one or more locations in
the lung, and endobronchially deploying a distal anchor of a lung volume
reduction device within the
lung at a target location after determining that the target location of the
lung is emphysematous tissue.
[024] To enhance the efficacy and safety of the sequential and stepwise
foreshortening procedures
anchors may have load monitoring means incorporated into their structure.
Alternatively load may be
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derived from the amount of spiraled tether as noted by fluoroscopy.
Alternatively the amount of
torque required to foreshorten a tether will indicate the forces acting on the
tether. In such systems
the force to displacement behavior may be monitored to indicate how the tissue
under volume
reduction is responding. When tissue begins to tear as noted by a decrease in
load associated with a
foreshortening the user may back off and lengthen that tether thereby removing
tension. Alternate
surrounding tethers or new tethers can be placed in the surrounding tissues.
Alternatively or in
combination some form of stepwise procedure may be instituted. In some
embodiments the force
displacement curves are displayed real time to the user. In some embodiments
the expected
maximum compression of portions of the lung to be treated will be predicted by
density and or
compliance measurements and these predictions used to inform the size of load
or displacement
increments to be applied during a sequential tether foreshortening procedure.
[025] In some circumstances, such as when the treatment in a non responder
provides no or minimal
clinically positive outcomes, it may be desired by the physician to return the
patient to the pre-
operative state, or as close as possible to it. Some embodiments include
reducing the tension applied
to the lung tissue. In other embodiments, the proximal anchor or the entering
anchoring device can
be removed.
[026] One aspect of the disclosure is a device for reducing the volume of a
lung, comprising: a distal
anchor, a proximal anchor, and a tether extending between the distal and
proximal anchors, the device
configured so that the distance between the anchors measured along the tether
can be increased or
decreased and maintained after release of a delivery device.
[027] In some embodiments of this aspect the device is further configured so
that the distance between
the anchors can be further increased or decreased after the device has been
released from a delivery
device.
[028] In some embodiments of this aspect the device further comprises a
tensioning controller that
interfaces with the tether, the tensioning controller configured to be
actuated to increase or decrease
the distance between the proximal and distal anchors.
[029] In some embodiments of this aspect a tether actual length between the
anchors stays the same.
The tether can be adapted to be reconfigured such that the distance measured
along the tether between
the anchors can be reduced. In some embodiments only a portion of the tether
is configured to be
reconfigured.
[030] In some embodiments of this aspect the tether is configured to wind up
on itself to decrease the
distance between the anchors.
[031] In some embodiments of this aspect the distal anchor is disposed at a
distal end of the device, the
proximal anchor disposed at a proximal end of the device, and the device does
not include any other
anchors disposed between the distal and proximal anchors.
[032] In some embodiments of this aspect the distal and proximal anchors are
expandable.
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[033] In some embodiments of this aspect at least one of the distal and
proximal anchors has an
electrode thereon.
[034] In some embodiments of this aspect the device is configured so that as
the distance between
anchors changes, a tether axis remains in the same direction. The axis can
remain in the same
direction even though the tether changes configuration.
[035] In some embodiments of this aspect the device is configured so that as
the distance between
anchors changes, the rotational orientation, out of a plane comprising the
tether axis, of the distal
anchor stays the same relative to the proximal anchor.
[036] In some embodiments of this aspect the proximal anchor is configured to
be collapsed and
removed from the lung after it has been expanded towards an expanded
configuration. The distal
anchor can be configured to be collapsed and removed from the lung after it
has been expanded
towards an expanded configuration.
[037] One aspect of the disclosure is a method of reducing the volume of a
lung, comprising
endobronchially deploying an anchoring device within the lung, the anchoring
device comprising a
distal anchor, a proximal anchor, and a tether extending between the distal
and proximal anchors, the
device configured such that the distance between the distal and proximal
anchors measured along the
tether can be increased or decreased and then maintained after release of the
anchoring device from a
delivery device; reducing the volume of the lung by decreasing the distance
between the distal and
proximal anchors; and maintaining the decreased distance.
[038] In some embodiments of this aspect the method further comprises, after
the positioning step,
releasing the anchoring device from a delivery device and removing the
delivery device from the lung
without decreasing the distance between the proximal and distal anchors,
wherein the reducing and
maintaining steps are performed after the releasing and removing steps. The
reducing and maintaining
steps can be performed after a second delivery device is endobronchially
positioned within the lung.
[039] In some embodiments of this aspect, after the maintaining step, waiting
a period of time during
which the distance between the anchors is not changed, and after the waiting
step, at least one of
increasing or decreasing the distance between the proximal and distal anchors.
The waiting step can
comprise monitoring a characteristic of the lung. The waiting step can
comprise waiting a period of
time for at least one of the following to occur: tissue relaxation, tissue
ingrowth into one or both
anchors; and a healing response in the volume reduced tissue. The method can
comprise, after the
waiting step, decreasing the distance between the proximal and distal anchors
to further reduce the
volume of the lung. The waiting step can comprise waiting at least 2 minutes
during which the
distance between the anchors is not changed.
[040] In some embodiments of this aspect decreasing the distance comprises
increasing the tension in
the tether.
[041] In some embodiments of this aspect, after the maintaining step,
increasing the tension in a second
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tether extending from a second distal anchor also positioned in the lung.
Increasing the tension in a
second tether can comprise increasing the tension in a second tether that is
coupled to a second
proximal anchor different than the proximal anchor. Increasing the tension in
a second tether can
comprise increasing the tension in a second tether that is coupled to the
proximal anchor.
[042] In some embodiments of this aspect the method further comprises
endobronchially positioning a
second anchoring device within the lung, the second anchoring device
comprising a second distal
anchor, a second proximal anchor, and a second tether extending between the
second distal and
second proximal anchors, the second device configured such that the distance
between the second
distal and second proximal anchors can be increased or decreased and then
maintained after release of
the second anchoring device from a delivery device.
[043] In some embodiments of this aspect decreasing the distance comprises
causing at least a portion
of the tether to wind up on itself.
[044] In some embodiments of this aspect the method further comprises, prior
to the deploying step,
characterizing a physical quality of lung tissue using an endobronchially
placed characterization
device. Characterizing a physical quality of a portion of the lung can
comprise characterizing a
physical quality of the lung that is indicative of emphysematous tissue. The
physical quality can be at
least one of tissue compliance and tissue density. After the characterizing
step characterizes the
portion of the lung as emphysematous tissue, the method can include anchoring
the distal anchor in
the emphysematous tissue. The characterizing step can comprise measuring the
electrical impedance
of the lung tissue. The method can also include determining a maximum tension
to apply to the distal
anchor using the results of the characterizing step.
[045] In some embodiments of this aspect decreasing the distance between the
distal and proximal
anchors comprises actuating a tension controller secured to the proximal
anchor.
[046] In some embodiments of this aspect the method further comprises, after
the reducing step,
increasing the lung volume by adjusting the anchoring device. Adjusting the
anchoring device can
comprise increasing the distance between the anchors. Adjusting the anchoring
device can comprise
removing the proximal anchor from the lung. Adjusting the anchoring device can
comprise removing
the distal anchor from the lung.
[047] One aspect of the disclosure is a method of reducing lung volume,
comprising endobronchially
positioning a tissue characterizing device within the lung; activating the
characterizing device at one
or more locations in the lung; and endobronchially deploying a distal anchor
of a lung volume
reduction device within the lung at a target location after determining that
the target location of the
lung is emphysematous tissue. The activating step comprises activating an
electrical impedance
device, wherein the distal anchor includes an electrode thereon. The
activating step can comprise
activating an electrical impedance device, wherein a delivery device includes
an electrode thereon.
The activating step can comprise activating an ultrasound device on a delivery
tool.
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[048] One aspect of the disclosure is a method of reducing lung volume,
comprising endobronchially
reducing a volume of lung with a lung volume reduction device; waiting a
period of time at least 2
minutes without further reducing the volume of the lung; and after the waiting
step, further reducing
the volume of the lung.
[049] One aspect of the disclosure is a method of reducing lung volume,
comprising endobronchially
reducing a volume of lung with a lung volume reduction device; after the
reducing step, waiting a
period of time without further reducing lung volume sufficient to allow at
least one of tissue
relaxation, tissue ingrowth into a part of the device; and a healing response
in the volume of reduced
tissue to occur; and after the waiting step, further reducing the volume of
the lung.
[050] One aspect of the disclosure is a method of reducing the volume of a
lung, comprising
endobronchially delivering an anchoring device to a location within the lung
within a delivery device,
the anchoring device comprising a distal anchor, a proximal anchor, and a
tether extending between
the distal and proximal anchors, the device configured such that the distance
between the distal and
proximal anchors measured along the tether can be increased or decreased and
then maintained after
release of the anchoring device from a delivery device; deploying the
anchoring device completely
out of the delivery device; and removing the delivery device from the lung
without increasing or
decreasing the distance between the proximal and distal anchors.
BRIEF DESCRIPTION OF THE DRAWINGS
[051] Figures 1A-1C illustrates an exemplary treatment device comprised of
three components.
[052] Figure 2 shows the airway anchor in a cutaway view.
[053] Figure 3 identifies structures of the lung for the purposes of
simplification. Additionally, a portion
of the parenchyma is afflicted with emphysema.
[054] Figure 4 shows a bronchoscope tracked into the airway leading to the
emphysematous tissue to be
treated.
[055] Figure 5 a distal anchor is deployed from the treatment device.
[056] Figure 6 the delivery sheath is withdrawn further back into the
bronchoscope to deploy the
proximal anchor.
[057] Figure 7 a drive shaft engages with the interface of a socket in the
proximal anchor.
[058] Figures 8A and 8B illustrate drive shaft rotation transmitted through
the socket and into the tether,
with the distal anchor drawn into closer proximity to the proximal anchor.
[059] Figure 9 a volumetric reduction in the emphysematous portion of the lung
can be observed.
[060] Figures 10 and 11 a preferred embodiment having a tension monitoring
mechanism is shown.
[061] Figures 12, 13A, 13B, 14A, 14B, 15, 16, 17, and 18 show a mechanism used
to hold and adjust
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tension within a tether. This design allows for a completely adjustable and
reversible tension to be
applied to tethers within the airways of the lung.
[062] Figure 19 shows a top view of an embodiment of a tensioning mechanism,
while
[063] Figure 20 shows the side view and Figure 21 shows the front of the same
design.
[064] Figure 22 shows a top view of another embodiment of a tensioning
mechanism while
10651 Figure 23 shows the side view of the same design.
10661 Figure 24 shows a top view of another embodiment of a tensioning
mechanism, while
10671 Figure 25 shows the side view of the same design.
[068] Figure 26 shows a top view of another embodiment of a tensioning
mechanism while
10691 Figure 27 shows the side view of the same design.
[070] Figure 28 shows an alternative embodiment to that shown in Figs. 29 and
30.
10711 Figure 29 shows a first embodiment of an adjustable anchor system for
lung volume reduction.
[072] Figure 30 shows the first embodiment of the adjustable anchor system for
lung volume reduction
after the tethers have been tightened.
[073] Figure 31 is a section view of an emphysematous lung.
[074] Figures 32 and 33 are an example of a single lung anchor utilized for
lung volume reduction.
Tension applied to the anchor in Figure 33 has exceeded the tensile strength
of the parenchyma
resulting in a tear.
[075] Figures 34 and 35 are an example of multiple lung anchors with applied
tension loads spread over
a larger area thereby avoiding tears in the surrounding tissue.
10761 Figures 36A-36D illustrate different outcomes to the surrounding tissue
based on the timing of
applied tension to distal anchors during lung volume reduction.
[077] Figure 37 shows the top view of one embodiment of a tensioning mechanism
for each tether;
[078] Figure 38 shows the side view of the same design.
[079] Figure 39 shows the top view of another embodiment of a tensioning
mechanism;
10801 Figure 40 shows the side view of the same design.
[081] Figure 41 shows the top view of another embodiment of a tensioning
mechanism, while
10821 Figure 42 shows the side view of the same design.
[083] Figure 43 shows the top view of another embodiment of a tensioning
mechanism;
[084] Figure 44 shows the bottom view from Figure 43.
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[085] Figure 45 shows a side view of the same design from Figure 43.
[086] Figure 46 shows a top view of tether and anchoring system, while
[087] Figure 47 shows a side view of the same design.
10881 Figure 48 shows a top view of tether and anchoring system, while
[089] Figure 49 shows a side view of the same design.
[090] Figure 50 a spring element design for the purpose of lung volume
reduction is shown.
[091] Figure 51 device shape-set to have a relaxed state resembling that of a
helix.
[092] Figure 52 device set to resemble a torsional spring.
[093] Figure 53 illustrates how a device with longitudinal element wrapping in
a spiral axis and
stretched would appear.
[094] Figure 54 shows a foreshortening for the helical design.
[095] Figure 55 illustrates that of the torsional spring configuration.
[096] Figure 56 the tissue along the airway wall surrounding the device is
engaged and drawn together.
[097] Figure 57 and figure 58 show tissue engaged and the feature length
simultaneously foreshortens
reducing the length of the tissue of the airway wall.
[098] Figure 59, a series of sharp tines run along the trailing edge of the
longitudinal element.
[099] Figure 60, tine feature can be incorporated into a raised element within
the face of the element.
[0100] Figure 61 shows another embodiment of a tensioning mechanism.
[0101] Figure 62 shows another embodiment of a tensioning mechanism.
[0102] Figure 63 shows another embodiment of a tensioning mechanism.
[0103] Figure 64, hypothetical target for volume reduction shown in the upper
right of the illustration.
[0104] Figure 65, single device or multiple devices are individually
introduced into the desired airway.
[0105] Figure 66, device is released and foreshortening from the spring force
it draws in the engaged
tissue, compressing the volume of the tissue attached to the airway in that
portion of the lung.
[0106] Figure 67, devices can stand alone as a unitary feature, or can be
connected to a central node.
[0107] Figures 68A and 68B show a flat pattern design for a stent-like anchor
that could be delivered to
the periphery of the airway in the lung.
[0108] Figure 69 shows a lung with a diseased upper lobe. An endoscope has
been tracked within the
bronchial tree so that its tip is engaging within the upper lobe.
[0109] Figure 70 shows a small diameter catheter is advanced into a segment of
distal bronchial lumen,
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the catheter tip in a segment of the bronchial tree having one or more
bifurcations within its structure.
[0110] Figure 71, a curable material is injected into the segment of distal
bronchial lumen.
[0111] Figure 72, additional small diameter catheters are placed, and curable
material injected and cured.
[0112] Figure 73, an anchoring catheter is advanced as far forward as
possible, stopping upon reaching a
bifurcation of the bronchial tree.
[0113] Figure 74, an anchor is deployed to stabilize the anchoring catheter in
the bronchial tree.
[0114] Figure 75, small diameter catheters are retracted back into the
anchoring catheter.
[0115] Figure 76, small diameter catheters are trimmed at the anchor, and the
anchor is detached from
the anchoring catheter.
[0116] Figure 77, a primary anchor balloon is deployed with a smaller
retractable balloon.
[0117] Figures 78A and 78B, an anchor balloon is established in an airway
through which a catheter
delivers flexible tubes capable of delivering an adhesive.
[0118] Figures 79A, 79B and 79C, a multi-lumen delivery catheter equipped to
install multiple
anchoring and adhesive points and to provide various treatment monitoring and
feedback
components is described.
[0119] Figure 79D, an outer airway wall is pierced by a hypo-tube or hollow
tether producing an
adhesive bleb at the outer airway wall.
[0120] Figures 80A-80C illustrate two possible styles of barbed lead.
[0121] Figures 81A-81B employ a "T"-style barbed lead in an alternate
anchoring system.
[0122] Figures 82A-82F and 83A-83B present another embodiment of the present
disclosure
incorporating the hypotube delivery of a looping stitch.
[0123] Figure 84 shows a graph of the relationship between load applied to a
distal anchor and the
resulting displacement of that anchor.
[0124] Figure 85 and Figure 86 show the impact of emphysematous tissue on the
relationship between
load applied and the resulting displacement of an anchor.
[0125] Figure 87 shows the relationship between torque applied to the line
attached to anchors described
in Fig. 85.
[0126] Figure 88 shows the torque applied in a line attached between anchors
as a function of the
number of turns applied to that anchor.
[0127] Figure 89A shows the line before it has reached its limit in number of
turns before forming a
loop.
[0128] Figure 89B shows the line having loops in it after the line has
increased past point "T" of Fig. 84.
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101291 Figure 90 illustrates an exemplary anchoring device with electrodes
disposed on the anchors.
[0130] Figure 91 presents a flow chart of possible steps for use in performing
a lung volume reduction as
described herein.
DETAILED DESCRIPTION OF DISCLOSURE
[0131] The disclosure describes methods, devices, and systems for reducing the
volume of a lung.
[0132] Figures 1A-1C and 2 illustrate an exemplary embodiment of a lung volume
reduction apparatus.
The embodiment in figures IA-1C and 2 is an example of a device for reducing
the volume of a lung
that includes a distal anchor, a proximal anchor, and a tether extending
between the distal and
proximal anchors, the device configured so that the distance between the
anchors measured along the
tether can be increased or decreased and maintained after release of a
delivery device. Apparatuses
and devices configured and/or adapted to reduce the volume of a lung may also
be referred to herein
as "treatment devices." The apparatus shown in figures 1A-1C includes three
components. The first
component is an airway anchor (1001) as shown in Figure 1A. An "airway anchor"
may also be
referred to herein as an "airway anchoring device" or other derivative. The
airway anchor is designed
to be collapsed into a small profile and delivered by the second component, a
delivery sheath (1002);
which is illustrated in figure 1B. The third component of the apparatus is a
drive shaft (1003), shown
in figure 1C, configured to tighten the airway anchor (1001) once the airway
anchor is positioned in
its target location. The act of "tightening" as used herein may also be
referred to herein as
"tensioning." Delivery sheath (1002) shown in figure 1B includes a lumen
configured to house
therein a plurality of separate anchoring devices, the plurality of anchoring
devices positioned along
the length of the lumen. That is, the anchoring devices are disposed within
the lumen axially from
one another rather than radially. In this embodiment an inner lumen of
delivery sheath includes four
anchor housing regions, each for receiving an anchor therein. The distal two
regions thus receive the
distal and proximal anchors of a first anchoring device, and the proximal two
regions receive the
distal and proximal anchors of a second anchoring device. The lumen can be
configured to stably
house any number of anchoring devices therein. The use of multiple anchoring
devices is described
below.
[0133] Figure 2 illustrates a sectional view of airway anchor (1001) from
figure 1A. The airway anchor
(1001) includes an actuable distal anchor (1005), which is configured to be
expanded from a first
compressed configuration that allows it to be collapsed within delivery sheath
(1002) for delivery to
an expanded configuration for engaging an airway wall. Such exemplary
expansible structures may
include laser cut nitinol, braided nitinol, inflatable structures, and the
like. The distal anchor (1005)
may comprise a plurality of tines (as described further below) to maintain
traction with the airway
wall. The airway anchor (1001) also includes tether (1004) that is fixedly
attached to the distal
anchor (1005) on one end, and attached to, while maintaining rotation freedom
from, the proximal
anchor (1006). In this embodiment tether (1004) is constructed of material
that maintains a high
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tensile and torsional strength to prevent breakage. In this embodiment tether
(1004) is also somewhat
flexible, so that upon twisting it is capable of winding itself into a non-
straight configuration, and
therefore becoming shorter without breaking or transmitting excessive torque
to the distal anchor.
[0134] In some embodiments the tether is any of or a combination of Dacron ,
Dyneema , Spectra and
Kevlar . The tether can be a wide variety of common fishing line. In some
embodiments braided
Dacron can be used. The tether can be a monofilament, a nanofilament (i.e.,
hundreds of
longitudinal strands), as well as braided.
[0135] Adequate volume reduction may be achieved with reductions in proximal
to distal anchor
distance associated with less than a few percent of initial length, especially
when initial tether length
is great, and up to 100%, especially when initial tether lengths are short.
Large reductions may be
effected in multiple smaller increments with time periods allowed between
reductions for tissue
relaxation or healing as is described elsewhere herein. The effect of the sum
of local anchor
adjustments will typically support lobal lung volume reductions of up to 30%,
more typically 20%,
and some situations, such as but not limited to when tissue is particularly
friable, less than 20%
perhaps only a few percent. Local tissue volume reductions may be even
greater.
[0136] In some embodiments the tether winds up on itself when twisted. In
these embodiments the tether
may wind up in a very controlled and repeatable configuration, or it may wind
up and take on a
variety of configurations. In either case the winding is reliable and
repeatable, even if the wound up
configuration is not completely predictable. In some embodiments the tether
could be material used
for fishing line, that when twisted will wind up, or bunch up, on itself.
[0137] The airway anchor (1001) also includes proximal anchor (1006).
Similarly to the distal anchor
(1005), proximal anchor (1006) is configured to be expansible from first
compressed configuration so
that it can fit within the delivery sheath (1002), to a larger expanded
configuration for engaging the
airway wall. Such expansible structures may include laser cut nitinol, braided
nitinol, or inflatable
structures and the like. The proximal anchor (1006) may optionally include a
plurality of tines (as
described further below) to maintain traction with the airway wall. The
anchoring device also
includes socket (1007), which is secured to the proximal anchor (1006), and
which is mechanically
connected to tether (1004), but allows the tether to rotate within and with
respect to the proximal
anchor. The socket (1007) includes an interface (1008) configured to receive
drive shaft (1003)
therein. The drive shaft and interface are configured such that the drive
shaft, when positioned in the
socket, is rotational fixed with respect to the socket. Rotation of the drive
shaft thus causes rotation of
the socket. This arrangement allows the user to engage the drive shaft (1003)
into the socket (1007) of
the proximal anchor (1006), and twist the tether by twisting the drive shaft.
The act of twisting the
tether changes the configuration of the tether from a straight configuration
to a non-straight
configuration, resulting in the distal and proximal anchors being drawn
together, and the distance
between the anchors measured along the tether reduced.
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[0138] Figures 1A-1C and 2 illustrate a merely exemplary lung volume reduction
device and additional
exemplary devices are descried below. Figures 3-9 illustrate an exemplary
method of using the device
shown in Figures 1A-1C and 2.
[0139] Figure 3 illustrates a portion of a lung, a complex organ composed of
airways, blood vessels,
alveolar tissue, lymphatic tissue among other structures. In this section,
only major airways (1009)
and parenchyma (1010) will be referred to for the purposes of simplification.
Major airways (1009)
refers to the bronchi that carry air to and from the parenchyma (1010) for
oxygen transport. The
parenchyma (1010) refers to all other structures in the lung, a majority
volume of which is alveolar
tissue. In figure 3, both major airways (1009) and parenchyma (1010) are
present. Additionally, a
portion of the parenchyma (1011) shown with grey shading is afflicted with
emphysema.
[0140] Figure 4 illustrates an initial step in the delivery of a treatment
device to a target location within
the lung. Bronchoscope (1012) has been navigated and tracked into the airway
leading to the
emphysematous tissue to be treated. Once in place, delivery sheath (1002) is
tracked distally into the
emphysematous tissue. The delivery sheath should be advanced as far as
practical, while avoiding
potentially rupturing the parenchyma.
[0141] In some embodiments the distal end of the delivery sheath will comprise
a tissue evaluation
device which is used to identify emphysematous tissue. One such evaluation
comprises the
measurement of the electrical impedance of the tissue. Alternative means
include but are not limited
to, ultrasonic, and optical means. Electrode elements 1131 comprised on the
distal end of the delivery
sheath (1013) are used query the adjacent tissue as the device is delivered
down the bronchi. If
emphysematous tissue is observed, as would be the case in the illustration of
figure 4, a distal anchor
may be placed.
[0142] Figure 5 illustrates a subsequent step (not necessarily immediate
after) in the delivery of the
device. As shown in figure 5, distal anchor (1005) has been deployed from the
delivery sheath and
has expanded into or towards its expanded configuration. Methods of deploying
an expandable
anchor from a delivery sheath are known, such as retracting a delivery sheath
relative to an anchor
whose position in maintained. The distal anchor optionally has a plurality of
tines (i.e., sharp
protrusions that puncture, hook into, or otherwise obtain traction) that
engage the airway wall in
which the anchor is deployed. In some embodiments there can be between 4- 300
barbs or tines that
engage the vessel wall, with larger numbers being preferred (but not required)
because the load
carried by the anchor will be better distributed as more tines are involved.
[0143] Distal anchor (1005) is configured to radially expand in response to
expansion of the airway in
which it is anchored. The anchor should be capable of 100% - 700% of the
maximum expansion
expected of the airway in which it is deployed. Providing such expansibility
will prevent the airway
from expanding to a diameter that exceeds the ability of the anchor to remain
engaged with the
airway, resulting in a loss of anchoring.
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[0144] A subsequent step (but not necessarily immediate after), as shown in
figure 6, is to deploy the
proximal anchor (1006) from the delivery sheath and expanding proximal anchor
(1006). Tether
(1004) can be seen extending between the distal anchor (1005) and the proximal
anchor (1006). The
delivery sheath (1002) can be withdrawn proximally to deploy the proximal
anchor (1006). The
tether (1004) maintains a mechanical connection between the distal anchor
(1005) and the proximal
anchor (1006).
[0145] Figure 7 shows, after the proximal anchor has been deployed at a target
location, a drive shaft
(1003) can then be tracked through the bronchoscope or through the sheath
contained within the
bronchoscope so that its distal end engages with the interface (1008) of the
socket (1007) in the
proximal anchor (1006). In this embodiment, when the drive shaft engages with
interface (1008), the
drive shaft and the socket are rotationally coupled.
[0146] As shown in figures 8A and 8B, the user then actuates (in this
embodiment by rotating) the drive
shaft (1003), causing the rotation to be transmitted through the socket (1007)
and into the tether
(1004). Rotating the drive shaft causes the tether to change configurations
from a first configuration
to a second configuration, which shortens the distance between the anchors. In
this embodiment, as
shown in the detailed view in figure 8B, the actuation causes a first portion
(1015) of the tether to coil
up into a non-straight configuration. This act of assuming a non-straight
configuration causes the
distal anchor (1005) to be drawn towards the proximal anchor into closer
proximity to the proximal
anchor (1006). The shortening of the distance between the distal anchor (1005)
and the proximal
anchor (1006) measured along the tether collapses the tissue between the
anchor and has caused a
volumetric reduction in the emphysematous portion of the lung.
[0147] Figure 9 illustrates the treatment device in place within the lung
after the bronchoscope has been
removed. At this stage the final outcome of the lung volume reduction
procedure can be observed.
[0148] Some treatment devices herein include tension monitoring mechanisms. A
tension monitoring
mechanism is configured to allow the amount of tension that is applied to the
tether to be monitored.
Figures 10 and 11 illustrate a treatment device that includes a tension
monitoring mechanism.
Tension monitoring mechanism (10016) includes a central marker (10017) that is
attached to the
distal end of tether (10004), compression spring (10018) that is positioned
between the central marker
(10017) and a proximal region of distal anchor (10005), and a plurality of
anchor markers (10019)
= that are fixedly attached to the distal anchor (10005) along the length
of the distal anchor.
[0149] In figure 10, the lung volume reduction system is shown with no tension
applied to tether
(10004). As a result, the compression spring (10018) does not have a
compressive load on it, and
maintains a fully elongated condition. The distance between the anchors along
the tether is a first
distance. Referring to figure 11, the lung volume reduction system has been
tensioned (using any of
the tensioning mechanisms and methods herein) within the airways (not shown)
in order to compress
them and their associated parenchyma. The tension carried in the tether
(10004) is transmitted to the
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compression spring (10018), which assumes a compressed condition as a result
of this applied load.
Because the spring constant k follows the typical linear relationship between
applied load F and its
degree of compression x, the spring equation F=k*x can be used to monitor the
tension in the tether
of the lung volume reduction system. A user may therefore monitor the position
of the central marker
(10017) relative to the position of the anchor markers (10019) in order to
determine the tension on the
lung volume reduction system. Additionally, the geometry of the compression
spring (10018) can be
controlled to the degree that the spring constant k can be known, allowing the
tension in the lung
volume reduction system to be known with accuracy. The central marker (10017)
and anchor
markers (10019) can be constructed from radiopaque materials so that they can
be seen using
fluoroscopy or other X-ray imaging techniques. Alternatively, they may be
constructed to be visible
via other methodologies (i.e. MRI, ultrasound, and the like).
101501 The embodiment in figures 10 and 11 also illustrates the manner in
which the distal anchor is
drawn closer to the proximal anchor when the tether is tensioned. The
embodiment in figures 10 and
11 is shown as manufactured, that is, outside of a lung. When the tether is
tensioned, the tether
changes configuration and becomes shorter as measured along the tether (as
shown in figure 11).
Because the tether is fixed to the distal anchor, the shortening of the tether
pulls on distal anchor
(10005) in the proximal direction "P" as shown in figure 11 (to the right in
the figure). The axis of
the tether stays the same when tensioned, even though the configuration may
change. For example,
the axis of the tether in figures 10 and 11 is the same direction even though
the configuration in figure
11 is wound up on itself. Tensioning the tether pulls the distal anchor in the
proximal direction "P"
towards the proximal anchor. In general, the distal anchor is pulled linearly
towards the proximal
anchor in the P direction. The distance between the distal anchor and proximal
anchor measured
along the tether is decreased, even though the actual length of the tether
between the anchors remains
the same (i.e., the tether winds up on itself, but the actual length of the
tether between the anchors
remains the same). Also, in the embodiment in figures 10 and 11 (and some
others herein), when the
distal anchor is pulled towards the proximal anchor, its rotational
orientation (out of a plane
comprising the tether axis) relative to the proximal anchor stays the same as
it is pulled towards the
proximal anchor. For purposes of simplification, when the embodiments herein
are described as
being configured such that the distance between distal and proximal anchors
can be reduced or
increased, they are being described in their as-manufactured configurations
(e.g., the embodiment
shown in figures 10 and 11), or what happens when actuated on a tabletop
outside of a lung.
[0151] In contrast to the descriptions in the paragraph above, a device that
has an initial straight
configuration and is configured to bend with a pullwire or other means, for
example, does not have a
distal anchor that moves towards a proximal end or proximal anchor as
described herein. For
example, when bent, the tether (bent) axis is not in the same direction as
when the device is straight.
Additionally, the distal end of the bend device does not have the same
rotational orientation relative to
the proximal end. These are examples of structural differences between devices
herein and devices
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configured to bend when actuated. Again, the structural descriptions and how
the devices are
configured reflect the devices when they are outside of the human body, in
their as-manufactured
configuration (although the devices are intended to change configurations in
the same or similar
manner when in use within the lung). When in use, the shortening of the
distance between the distal
anchor (10005) and the proximal anchor (10006) measured along the tether
causes a volumetric
reduction in the emphysematous portion of the lung.
101521 In some alternative embodiment to that shown in figures 10 and 11, the
distance central marker
(10017) travels can also be used to determine how much the distance between
the anchors changes, if
a correlation exists between the distance central marker (10017) travels and
the distance the tether
shortens in the portion that changes configuration.
[0153] Figures 12 through 18 illustrate an exemplary mechanism configured to
hold and adjust tension
on a tether. This design includes a stent like tube (12020) shown in figure
14A, into which an
expandable structure is cut. In one end of this tube a window (12022) is cut
as illustrated in fig. 14A
and corresponding inset fig.14B. The spring like element of fig. 15 (12023) is
cut into a smaller tube
that fits within the distal end of the larger tube 12020 and rests upon the
flange of fig. 18 (12026)
fixed within the inner diameter of the outer tube. This flange prevents the
element from moving
beyond the tube under tension but allows for the element to rotate. A tab
(12021) is cut into the
smaller tube, which is then shape-set to extend slightly out of the surface of
the inner tube and into
that of the outer tube. The tab fits within the window of the outer tube. When
the drive shaft of fig. 17
(12003) with interface tip (12025) is advanced to the interface of the spring
element (12024) and is
rotated the element twists and the tab allows for rotational motion in only
one direction. The
orientation of the tab results in any rotational motion that is opposite of
that which is desired being
halted. This feature allows for tension to be increased or decreased and held
in place. By rotating the
tether it twists and foreshortens drawing the distal anchor it is affixed to
in towards this proximal
ratcheting structure. Should it be desired to release the tension in the line
the drive shaft can be
advanced further as to depress the spring of the spring element within the
outer tube. When this
spring is depressed the raised tab is forced to lay flat as it is disengages
from the outer tube window it
extends into. As it is disengaged it is free to spin freely within the
stationary outer tube. This design
allows for a completely adjustable and reversible tension to be applied to
tethers within the airways of
the lung.
[0154] Figures 19-21 illustrate an exemplary embodiment of an apparatus
configured to tighten the tether
and thus reduce the volume of the lung. Only a portion of the treatment device
is shown in this
embodiment for clarity. Figure 19 shows a back view, figure 20 shows the side
view, and figure 21
shows the front view. In the side view of figure 20, the distal direction is
downward. The treatment
device includes a proximal anchor, which includes an expandable stent like
structure (19027) coupled
to an internal ratcheting shaft (19029). The ratcheting shaft (19029) has an
interface (19008) that is
configured to receive a drive shaft therein such that the drive shaft and
ratcheting shaft (19029) are
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rotationally coupled. As the shaft rotates within the outer tube the keyed
channels machined into the
shaft (19030) also rotate. The outer tube is shaped in such a way that there
are tabs (19028) set down
to interface with the keyed channels of the inner shaft. The outer stent like
structure remains
rotationally fixed within the tissue and as an external torque is applied
rotating the shaft the tabs snap
into the keyed channels of the ratcheting shaft. These tabs are designed in
such a way to provide just
enough resistance to ensure no rotation in either direction without the
introduction of external force.
This allows for the operator to selectively set the tension within the tether
attached to the distal
portion of the inner shaft. As the shaft is rotated, the motion is transferred
to the tether (19004). By
setting the external stent like structure as well as the distal anchor in
place, the torque applied to the
tether is captured within the line resulting in a reduction of the tether
length, thus reducing the volume
of the lung. The drive shaft can then at any time be repositioned within the
interface to modify the
tether configuration to increase or decrease the distance between the anchors.
[0155] Figures 22 and 23 illustrate another exemplary embodiment of an
apparatus configured to tighten
the tether and thus reduce the volume of the lung. Figure 22 is a top view and
figure 23 is a side
view. Only a portion of the treatment device is shown. In this embodiment
there is an outer tube with
an internal spring loaded collar (22031) resting on a flange at the distal tip
of the tube. The tether
(22024) is affixed to the distal end of a core shaft (22032) within the spring
element. A drive shaft is
inserted into the interface (22008) with an integrated feature that depresses
the collar releasing the
catch feature of the inner shaft from the pocket it fits into within the
collar. By releasing this feature
the shaft is free to rotate in both directions. The drive shaft is used to
apply torque to the tether
through this inner shaft. Once the desired torque is reached the drive shaft
is withdrawn which allows
the spring loaded collar to again snap over the catch feature of the inner
shaft preventing any
additional rotation or release of tension. In this way the tether is
maintained in a desired
configuration. The drive shaft can then at any time be repositioned within
interface 22008 to modify
the tether configuration to increase or decrease the distance between the
anchors.
[0156] Figures 24 and 25 illustrate another embodiment of an apparatus
configured to tighten the tether
and thus reduce the volume of the lung. Figure 24 shows a top view and figure
25 shows a side view,
and only a portion of the treatment device is shown for clarity. In this
embodiment the proximal
anchor includes an outer stent like structure (24027) cut into a tube and a
pocketed collar (24033) that
rests within the inner diameter of this tube. The tether (24004) runs through
the inner channel of the
collar (24035) that is fixed within the outer tube. This tether terminates in
a catch (24034) that is
shaped in such a way that it fits within the pocket of the collar (24033). A
drive shaft is advanced to
the collar and interfaces with the catch which is pulled proximally slightly
to free it from the pocket it
rests within. Torque is then applied to the catch which is transferred to the
tether to foreshorten it.
Once the desired tension is reached the catch is placed back into the pocket
of the collar. The tension
within the line keeps the catch seated within the collar which in turn
prevents any additional rotation
or release of tension within the tether. In this way the tether is maintained
in a desired configuration.
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The drive shaft can then at any time be repositioned within the interface to
modify the tether
configuration to increase or decrease the distance between the anchors.
[0157] Figures 26 and 27 illustrate another embodiment of an apparatus
configured to tighten the tether
and thus reduce the volume of the lung. Figure 26 shows a top view and figure
27 shows a side view.
Only a portion of the treatment device is shown for clarity. This embodiment
includes two stent like
tubular elements. The outer tubular element (26027) is set and an internal
tubular element (26036) is
inverted in such a way that the expanded features of this inner tubular
element interfaces with those
of the outer tubular element. This interface prevents any rotation until a
drive shaft is used to
introduce the necessary force to rotate the inner tubular element. The
internal stent rotates within the
stationary external tubular element and the inverted members snap out in
between each longitudinal
element of the external tubular element. Once the desired torque is reached
the drive shaft is
withdrawn and the interference between the elements of the two tubular
elements prevents any
additional rotation or loss of tension in the tether (26004). In this way the
tether is maintained in a
desired configuration. The drive shaft can then at any time be repositioned
within the interface to
modify the tether configuration to increase or decrease the distance between
the anchors.
Alternatively, the drive shaft may be configured to reversibly lock to the
internal tubular element. In
such an embodiment the internal tubular element is drawn proximally to rotate,
either for
foreshortening or lengthening. Upon completion of the adjustment step the
drive shaft is released and
the tension between the distal and proximal anchors holds the inner tubular
element in the rotationally
interlocked position relative to the outer tubular element.
101581 Figure 28 illustrates an embodiment of a method of reducing the volume
of a lung by positioning
a plurality of separated treatment devices with the lung. In this embodiment
each of the individual
treatment devices includes a distal anchor (28005), a proximal anchor (28006),
and a tether (28004),
similar to the embodiment shown in figures 1A-1C and figure 2. Each of the
individual treatment
devices can be actuated with a drive shaft to control the tension in the
respective tether and thus the
distance between the respective distal and proximal anchors. The physician may
evaluate the
resulting tissue response and may decide to continue treatment by increasing,
decreasing, or
maintaining the tension on each tether. The tension may be applied to all
tethers uniformly, or may be
applied individually depending on the adjustable proximal anchor design.
Furthermore, the physician
may choose to completely eliminate tension on the tether between anchors if it
is no longer desired.
[0159] In some embodiments a treatment device includes a plurality of distal
anchors coupled to one
proximal anchor. A tensioning component secured to the proximal anchor is
actuated to modify the
tension in the plurality of tethers. Each of the plurality of tethers can be
individually tensioned or they
can be tensioned together. The configuration of each of the tethers can thus
be different, or the tethers
can all change configurations to the same extent. Figure 29 illustrates an
exemplary embodiment in
which the treatment device has been positioned within the lung and the
plurality of distal anchors and
the single proximal anchor are expanded and anchored to respective lumens.
Figure 30 illustrates the
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treatment device after each of the tethers has been tensioned, which has
pulled each of the distal
anchors towards the proximal anchor. In this exemplary embodiment each tether
is coupled to the
proximal anchor at substantially the same location. In this embodiment of an
adjustable anchor
system for lung volume reduction, the apparatus includes a plurality of distal
anchors (29005), an
adjustable proximal anchor (29006), and tethers (29004) connecting the distal
anchors and the
adjustable proximal anchors. As previously discussed, the tethers may also be
tightened in a stepwise
fashion over time to provide maximal lung volume reduction while minimizing
the chance of tearing
of the parenchyma and other unwanted side effects (i.e. inflammation, bleeding
etc.). Figure 30
shows the apparatus after the tethers (29004) have been tightened and the
delivery device removed.
Because all of the anchors (29005) are tethered to a single adjustable
proximal anchor (29006), they
will all be drawn together towards a single location. The physician may
evaluate the resulting tissue
response and may decide to continue treatment by increasing, decreasing, or
maintaining the tension
on each tether. The tension may be applied to all tethers uniformly, or may be
applied individually
depending on the adjustable proximal anchor design. Furthermore, the physician
may choose to
completely eliminate tension on the tether between anchors if it is no longer
desired.
[01601 The method shown in figure 28 may have an advantage of use when the
lung tissues are more
diseased and are not able to support the localized loading associated with a
single location adjustable
proximal anchor, such as in the embodiment shown in figures 29 and 30. The
method shown in figure
28 also allows the physician to only need to consider a single airway when
placing each of the
devices. Likewise, tensioning could be a simpler procedure because only one
tensioning line is
present in the airway, whereas the design shown in figures 29 and 30 could
require the user to
discriminate between tensioning mechanisms for each tether. Alternatively, in
some lungs there may
not be enough healthy lumens in which to anchor more than one proximal anchor.
In those situations
it may not be safe to use more than one anchoring device, each with its own
proximal anchor. In
these situations a single proximal anchor design may provide the benefit of
being able to be anchored
in a single healthy tissue lumen while still being connected to a plurality of
distal anchors. For
example, in the embodiment in figures 29 and 30, only proximal anchor (29006)
need be anchored in
healthy tissue. In figure 28, proximal anchor (28006) is anchored in healthy
tissue. But if in figure 28
three healthy lumens cannot be detected, a choice of the procedure may be to
use a single proximal
anchor device.
[0161] Figures 31-36 illustrate methods of use that can be used when placing a
plurality of distal anchors
in different lumens, regardless if one or more proximal anchors are used.
Proximal anchors are thus
not shown for clarity, but may be a single proximal anchor or a plurality of
proximal anchors as
described herein. Figure 31 illustrates a sectional view of a portion of an
emphysematous lung.
Figure 31 shows a surface of the lung, or visceral pleura (31038), a network
of airways (31039), and a
finer structure of bronchioles, blood vessels, and alveolar tissue herein
referred to as the parenchyma
(31010). Figure 32 illustrates a single lung distal anchor (32040) configured
for lung volume
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reduction. Tension (T) is applied to the anchor in figure 33 via a proximal
anchor and tether (not
shown for clarity), causing the adjacent airway (33041) to foreshorten. The
tension is transmitted to
the parenchyma (33010) surrounding the airway. The parenchyma (33010) is a
delicate tissue, and in
this case, the tension has exceeded the tensile strength of the parenchyma
(33010), resulting in a tear
(33042). The tear (33042) causes a degree of mechanical isolation between the
airway containing the
anchor and the outer extremities of the adjacent parenchyma, preventing the
applied tension from
reaching those extremities. As a result, the lung volume reduction is smaller
than if no tear had
occurred. Tearing is an undesired consequence and should be prevented.
[0162] Figures 34 and 35 illustrate an exemplary embodiment of a method using
a plurality of distal
anchors for lung volume reduction. In this embodiment a plurality of lung
anchors (34044) are
utilized. Tensions (T1, T2, T3, T4) are applied by tethers (see figure 35)
interfacing either a single or
multiple proximal anchors (not shown) causing the adjacent airways (35045) to
foreshorten. The
tensions are transmitted to the parenchyma (35010) area surrounding the
airways (35045). While the
parenchyma tissue (35010) remains delicate, the applied loads are spread over
a larger area, and do
not exceed the tensile strength of the parenchyma. As a result, no tear is
formed, and the applied
tensions can reach the outer extremities of the parenchyma. A much more
effective lung volume
reduction is achieved by avoiding tearing of the parenchymal tissue.
[0163] Figures 36A-36D illustrate an embodiment in which tension in respective
tethers can be
individually controlled. This embodiment also illustrates advantages of timing
aspects of tensioning a
plurality of tethers. Figure 36A illustrates a portion of an emphysematous
portion of the lung, wherein
a plurality of lung anchors (36040) have been placed. Figure 36B shows a
potential result if a high
level of tension is immediately placed on the anchors (36040). Tears (36047)
are formed due to the
high level of tension applied resulting in a reduced ability to reduce lung
volume as similarly
discussed for Fig. 33. Alternatively, figures 36C and 36D illustrate a result
if the tension to the
tethers and anchors is applied stepwise and sequentially. An initial tension
applied to all anchors as
shown in figure 36C is significantly less than what will cause tearing in the
parenchyma. After the
initial tensioning, a period of time is allowed to elapse before applying
additional tension. After the
period of time has elapsed, additional tensioning is applied to all of the
anchors, as shown in figure
36D. By performing the tensioning in a stepwise and sequential fashion,
healing can occur in the
tissue between tensioning events, which will allow greater ultimate
deformation in the tissue without
tearing. Another advantage of this stepwise tensioning is that any
inflammation or other biological
response from each tensioning event can subside before performing the next
tensioning event.
Additionally, imaging studies (e.g., X-ray, CT, MRI, and the like) may be
performed between
tensioning events to evaluate the impact of the previous tensioning event, and
provide guidance for
further tensioning events. Varying levels of tension may be applied to each
anchor in order to
maximize its reduction in lung volume, while preventing tearing of the
parenchyma. In some
situations it will be appropriate to perform the procedure in either a
stepwise or a sequential fashion.
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In some embodiments in which stepwise and sequential tensioning are performed,
one proximal
anchor is used, and in some embodiments a plurality of proximal anchors are
used.
101641 In some of the embodiments herein, a tensioning controller is used to
modify the tension in a
plurality of tethers. Figures 37-44 illustrate exemplary embodiments in which
a plurality of tethers
can be controlled with a single tensioning controller. Figure 37 is a top view
and figure 38 is a side
view of one embodiment of a tensioning apparatus configured to tighten a
plurality of tethers of a
treatment device to draw the distal anchors closer to a proximal anchor and
reduce the volume of the
lung. The tensioning apparatus is also configured so that the tension in the
tethers can be modified
repeatedly over time even after a delivery device has been removed from the
lung. In this
embodiment a drive shaft can be inserted into interface (37048) and motion
clockwise or counter-
clockwise is translated into radial motion of the main geared collar (37049)
shown in the side view of
figure 38. The teeth of this collar (37050) interface with the gear (37051) of
each tether spool
(37052). As the drive shaft and collar are rotated, the tether (37004) is
either wound or unwound for
each spool depending on the direction of rotation. Winding or unwinding the
tether decreases or
increases the distance between the anchors as described herein.
101651 Figures 39 and 40 illustrate an alternative embodiment of a tensioning
controller configured to
modify the tension in a plurality of tethers. In this embodiment the
tensioning controller is configured
to be able to individually tension each tether, rather than tensioning all
tethers at the same time.
Figure 39 shows a top view and figure 40 shows the side view. This embodiment
in similar to the
embodiment in figure 37 and 38 but in this embodiment the spool engagement is
different. In this
design the teeth of the collar (39050) are on a gear mounted on the collar.
The collar (39049) is
configured to be rotated until it is over the particular spool (39052) for
which tension is desired. The
collar is then depressed which engages that particular spool gear (39051). The
collar gear is
connected to the drive shaft interface (39048) via a worm drive. When the
collar is depressed and the
drive shaft rotates, so does the collar gear. This motion is transferred to
the spool which winds or
unwinds the particular tether (39004) depending on the direction of rotation.
Each tether can thus be
individually tensioned. This allows each of a plurality of distal anchors to
be individually controlled.
In alternative embodiments the tensioning controlled is configured to tension
more than one tether at
the same time, but is also configured to not tension one or more other tethers
at that time.
[0166] Figure 41 and 42 illustrate an exemplary embodiment of a tensioning
controller configured to
tension tethers individually. Figure 41 shows a top view and figure 42 shows a
side view. In this
embodiment a drive shaft (41003) is inserted into a drive shaft interface
(41048) thereby connecting
that interface to a spool drive (41050). As each shaft is rotated its
corresponding spool (41052) also
rotates as it is interfaced to the spool drive through a gear (41051) which
winds and unwinds the
tether (41004). While this could be adapted to any number of spools, this
embodiment illustrates a
configuration of 4 different spools that can be utilized individually to
tension individual tethers.
[0167] Figures 43-45 illustrate an alternative embodiment of a tensioning
controller configured to
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tension tethers together. Figure 43 is a top view, figure 44 is a side view,
and figure 45 is a bottom
view. In this design a core rod (not shown) connects the drive shaft interface
(43048) to the collar
gear (43050). All of the spools (43052) can be advanced on its center shaft
which engages its spool
gear (43051) with the collar gear. As the gear is rotated, whichever spool is
engaged also rotates
winding or unwinding the tether (43004) to draw tension in the lines.
101681 Figures 46-49 illustrate two tether and anchoring apparatuses. Figures
46 and 47 are side views,
respectively, of one embodiment. In this embodiment, in use, a cleating system
(46053) is placed
over a bifurcation of an airway within the lungs. The barbed catch features
(46055) (see figure 47)
interface with the tissue at the bifurcation to help prevent the cleat from
backing off or coming loose
from the tissue once positioned. The tether (46004) is affixed to a distal
anchor within the airway and
the proximal end of the tether is fed through the interface with the cleat
(46054). This interface is
configured in such a way that it ratchets over the ball on a line design of
the tether. As tension is
pulled on the tether the balls advance through the cleat, which snaps over
each capturing the line and
ensuring the tension within the line is maintained.
101691 Figures 48 and 49 illustrate an alternative embodiment of a tether and
anchoring apparatus, with
top and side views, respectively. This design is similar to that illustrated
in figures 46 and 47 with the
exception of the tether design and its interface with the cleat. As opposed to
the balls on a line design
this embodiment utilizes a ladder like design (48004) and the interface with
the cleat (48053) has a
step that is extended. As the tether is advanced into the cleat a raised stop
(48055) snaps into each
rung of the ladder holding the line in place and preventing the tension within
the line from being
released.
101701 In some embodiments the tether comprises a spring or spring-like
element (generally referred to
herein as a "spring"). The spring can be stretched to an extended length, as
shown in the exemplary
embodiment in figure 50, and released. This device could be shape-set to have
a relaxed state
resembling that of a helix, such as is as shown in figure 51, where the edge
of each element (50056)
comes into contact with itself along the trailing edge as is wraps around the
spiral path. The device
could also be set to resemble a torsional spring, such as in the exemplary
embodiment shown in figure
52. In this torsional spring configuration the longitudinal elements on
opposing ends of the device lay
over one another as they wrap in ever increasing diameters. While the helical
and torsional spring
designs could be stretched prior to delivery and appear to have the same
pattern, when the two
designs relax the amount they foreshorten as well as radial expand will vary.
Figure 53 illustrates
how a device with longitudinal element wrapping in a spiral axis and stretched
would appear. The
overall device length (Ldev,õ) and feature length (Lfeature) will be greater
than the relaxed stated. As the
device is released there is uniform engagement along the length of the device
as the total length of the
device and the feature length reduce. Figure 54 shows this foreshortening for
the helical design, while
figure 55 illustrates the foreshortening of a torsional spring configuration.
As the elements draw
together from the spring force stored within the device, the tissue along the
airway wall surrounding
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the device (50057), seen in figure 56, is engaged and drawn together. This
uniform engagement of the
tissue (50058) occurs between the trailing edges of the elements as shown in
the reconfigured states
shown in figures 57 and 58. As the tissue is engaged and the feature length
simultaneously
foreshortens, the length of the tissue of the wall also reduces, reducing the
volume of the lung.
101711 Figures 59 and 60 illustrate exemplary ways to increase the extent of
tissue engagement and
improve reduction. In figure 59 a plurality of sharp tines (59061) run along
the trailing edge of the
longitudinal element. By incorporating this feature into either a helical or
torsional spring design the
tissue would be less apt to slip or become disengaged from the surface of that
element as the device
length shortens. Figure 60 illustrates how this tine feature can be
incorporated into a raised element
(59059) within the face of the element. One potential means for deploying or
raising this feature
would be to include a release wire (59060) within the design. The raised
feature could be shape-set in
a deployed, expanded, state, and then held flat until desired via the wire
which would be woven over
each raised feature and under the main structure of the longitudinal element.
By withdrawing this
wire the tines would be allowed to raise and become proud. If the procedure
dictates this be done
prior to releasing the stored spring force of the device, the tines could
further ensure tissue
engagement as the elements draw together. This release wire could also be used
in the design
illustrated in figure 59 to control the width or length of the longitudinal
elements (59059). Through
controlling these items the tines could be allowed to further engage the
tissue through the release of
some stored spring energy within the element.
101721 Figure 61 illustrates an alternative embodiment of a tensioning
mechanism in a treatment device.
In this embodiment spool (61063) is set on a fixed diameter portion on a tube
(61004) into which a
stent like reconfigurable structure is cut at both ends of the tube on either
side of the spool. These
expanded elements keep the structure in place within the airway while a tether
that runs from a distal
anchor to this structure is wound up on the spool. A drive shaft is advanced
to the structure and when
rotated the spool also rotates which winds and unwinds the tether (61004)
depending on the direction
of rotation. A ratcheting feature is integrated into the spool and tube
interface to prevent any
undesired rotation of the spool. This design allows for a desired tension to
be applied to the tether and
maintained.
101731 Figure 62 illustrates an alternative embodiment of a tensioning
mechanism in a treatment device.
In this embodiment a stent like structure is cut into a tube (62064) which is
then inverted. It is onto
this inverted potion of the tube that a spool (62063) is mounted. A drive
shaft is then advanced to the
structure where it interfaces with the core rod of the spool (62065). Any
rotation of the drive shaft is
transferred to the spool which winds or unwinds the tether (62004) depending
on direction of rotation.
A ratcheting feature is integrated into the spool and tube interface to
prevent any undesired rotation of
the spool. This design allows for a desired tension to be applied to the
tether and maintained.
101741 Figure 63 shows another embodiment of a tensioning mechanism. This
design is a slight variation
of that show in figure 62. This design also utilizes a spool (63063) mounted
on a laser cut tube
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(63066) that is used to hold and adjust tension by winding and unwinding the
tether (63004). The
variation for this design is that the stent like structure cut into the tube
is only incorporated into one
end of the tube. The stent-like structure in this embodiment has a tapered
proximal end, and as such
is configured to be collapsed and retrieved into a retrieval catheter upon
engagement between the
tapered end and the retrieval catheter (a retrieval catheter could be advanced
or the stent-like structure
could be proximally withdrawn to initiate the collapse of the structure). The
distal anchor could also
be configured in such a way to allow for its collapse and retrieval subsequent
to the proximal anchor
retrieval. Retrieval of the proximal anchor or both anchors can be performed
to reduce tension that
has been applied to the lung, or return the patient towards the pre-operative
states (regardless of
whether the actual pre-op state is fully achieved or not). If just the
proximal anchor is to be removed,
the tether can be cut, leaving the distal anchor implanted.
[0175] Figures 64-67 describe alternative methods and devices for lung volume
reduction. Figure 64
shows an illustration of a hypothetical human lung for a patient suffering
from emphysema. The
hypothetical target tissue for volume reduction (64067) is identified in the
left superior lobe, or upper
right of the illustration. Each device is individually introduced into the
desired airway (64068) of the
lung. A single device (65057) can be delivered to a single airway or multiple
devices to several
airways, as seen in figure 65. The device is released, and as it foreshortens
from the spring force it
draws in the engaged tissue, reducing the volume of the tissue attached to the
airway in that portion of
the lung, as seen in figure 66. The devices can stand alone as a unitary
feature, or can be connected to
a central node (67069) at a bifurcation via anchoring lines (67070) as shown
in figure 67. Should
anchoring lines be drawn to a node a tethering system could be used to fix the
lines and hold them in
place. This system could allow for adjustability through the ability to
individually change the tension
on each of the anchoring lines. Each device is removable, as is any node or
anchoring line that may
be added as an option. The devices (65057) may be comprised of a super elastic
material such as but
not limited to memory metals. Additionally, in some configurations the
elements (65057) may rely on
the memory characteristics to transform from a delivery to a delivered
configuration at implant. In
particular as is known the device (65057) can be delivered at one temperature
lower than body
temperature, and rely on body heat to bring about a transition into the
compressed state.
Alternatively, the design can comprise a transition temperature greater then
body temperature and rely
on heating the device (65057) after delivery using the delivery tool, either
by direct heating or joule
heating mediated by inductive coupling.
[0176] Figures 68A and 68B illustrate an exemplary flat pattern design for a
stent-like anchor that could
be delivered to the periphery of the airway in the lung. The embodiment in
figures 68A and 68B
could be delivered according to the methods in figures 64-67. The anchor would
be fixed to a tether
attached to the proximal ring or proximal anchor (not shown). When deployed
the device is capable
of expanding to roughly five times its original diameter. As the device
expands the distance between
the longitudinal elements (68071) increases which straightens out the struts
(68072). The tines
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(68073) would be placed along the ends of each of these struts and be
configured such that either
through shape-setting or mechanical interface would become proud and stick up
from the expanded
surface of the device. These tines would engage the tissue and help to hold
the anchor in position
within the airway. Through sizing and potentially shape-setting, the final
diameter of the device is in
excess of that of the airway it in the deployed state. As such, the device
remains in contact with the
tissue of the airway wall as the airway moves and the diameter fluctuates.
Having affixed to the distal
portion of the airway, the tethers could then be pulled to the appropriate
tension for each device and
the tethers gathered at a node, much like that previously shown in figure 67.
By drawing in each
anchor and pulling the airways the volume of that portion of the lung is
reduced. Should adjustments
need to be made the tension in each line could be adjusted (examples of which
are described herein),
or the tether cut all-together to release that portion of tissue. This
adjustability and removability
ensures that the device platform is applicable to the widest range of patient
needs and procedural
constraints.
[0177] Figure 69 illustrates a lung (69074) with a diseased upper lobe
(69075). The diseased upper lobe
is characterized as having a poor oxygen transport and may additionally be
hyperinflated (i.e., having
a larger volume than it would in a healthy state). Hyper-inflation is not
shown here, but it can be
appreciated that it would have a larger volume and compress the lower lobe
(69076) due to the spatial
constraints within the chest cavity. An endoscope (69077) has been tracked
within the bronchial tree
so that its tip is engaging within the upper lobe.
[0178] Figure 70 illustrates a close up view of the diseased upper lobe of the
lung, and a first step in the
lung volume reduction procedure. A small diameter catheter (70079a) is
advanced into a segment of
distal bronchial lumen (70078). The small diameter catheter may be advanced
directly, or may be
advanced with the aid of a guidewire if the risk of damaging the bronchial
tree is considered to be
high. The tip of the small diameter catheter (70080) is placed in a segment of
the bronchial tree
having one or more bifurcations within its structure.
[0179] Figure 71 shows a next step in the lung volume reduction procedure.
With the small diameter
catheter (71079a) placed in the diseased upper lobe, a curable material
(71081a) is injected into the
segment of distal bronchial lumen. The material is then cured to transform
from a fluid (i.e.,
flowable) to a solid (i.e., non-flowable) state. Upon curing, the distal end
of the catheter is bonded
within and affixed to the cured material (71081a).
[0180] Figure 72 illustrates additional small diameter catheters (72079b,
72079c) positioned within the
lung, and curable material (72081b, 72081c) injected and cured to affix the
catheters within the
material as described in figure 71.
[0181] Figure 73 shows that once the small diameter catheters (73079a, 73079b,
73079c) are in place and
affixed to the injected curable material, an anchoring catheter (73083) is
advanced as far forward
(distally) as possible. The advancement of the anchoring catheter is stopped
upon reaching a
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bifurcation (73084) where at least one of the small diameter catheters passes
down a different branch
of the bronchial tree than one or more other small diameter catheters.
[0182] Figure 74 shows that once the anchoring catheter (74083) is in place,
an anchor (74085) can be
deployed to stabilize the anchoring catheter in the bronchial tree. In this
case, the anchor (74085) is
shown as a balloon that has been inflated with a curable material so that it
cannot deflate once the
material has cured. Alternatively, the balloon could be inflated with a more
common fluid (e.g.,
saline, air) and the pressure maintained via a one-way valve in the inflation
lumen.
[0183] Figure 75 illustrates that with the proximal anchor deployed, the small
diameter catheters are
retracted back into the anchoring catheter. The applied tension is transmitted
through the small
diameter catheters into the curable material injected into the distal bronchi,
and into the lung tissue
itself. Because the curable material has formed the shape of the distal
bronchi, including one or more
bifurcations, it cannot slip within the bronchi, but must displace the lung
tissue centrally towards the
anchoring catheter. As a result of the displacement of lung tissue toward the
centrally located anchor
catheter, the lung volume is effectively reduced.
101841 Figure 76 shows that once lung volume reduction has occurred, the small
diameter catheters are
trimmed at the anchor, and the anchor is detached from the anchoring catheter.
The small diameter
catheters are locked within the anchor, preventing the lung tissue from
expanding back into its
previous hyper-inflated condition.
[0185] Figure 77 illustrates an alternate embodiment in which a primary anchor
balloon (77086) is
deployed with a retractable distal secondary balloon (77087) to a target
location. Once primary
anchor balloon (77086) is positioned, secondary balloon (77087) is advanced
within an airway to a
diseased area of the lung (77088). Extending through the delivery catheter is
a lumen capable of
delivering an adhesive to the distal end of the balloon assembly. Upon
placement of balloon (77087)
an adhesive is delivered (77089) to seal the airway and secure the distal
balloon in place. After
adhesive curing, balloon (77087) is pulled upward toward primary balloon
(77086) thereby
compressing the airway below.
101861 Figures 78A and 78B illustrate an additional exemplary method of lung
volume reduction. An
anchor balloon (78041) is anchored in an airway. Extending through the
delivery catheter are a
plurality of flexible tubes (78090) adapted to deliver an adhesive. The
adhesive tubes are extended
distally from the anchor balloon and an adhesive is expelled into the diseased
area (78091). The
adhesive delivery tube may be comprised of or comprise a fiber optic material
able to deliver a curing
light to the adhesive area in vivo. After curing, the adhesive tubes are
pulled upward bringing the
bound tissue with it and compressing that portion of the target area (78092).
101871 Figures 79A-79C illustrate an additional exemplary method of lung
volume reduction. Multi-
lumen delivery catheter (79093) includes adhesive delivery tubes (79094),
directable hypo-tubes able
to pierce an airway (79095), adhesive curing element, intra-bronchial
ultrasound and/or local
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ventilation monitor for local evaluation, or other auxiliary devices (79100).
Hypo-tubes (79095) are
configured to deliver a barbed lead (79102) through the airway, the leads able
to expand and anchor
to the airway. Adhesive is then delivered to the area (79103) to seal diseased
alveoli (79104) and
airway tissue and to secure the anchors to the airway. The catheter can be
used to install multiple
anchor and adhesive points, pulling the anchor leads upward and compressing
the targeted tissue.
[0188] Figure 79D illustrates an outer airway wall (79106) that has been
pierced by a hypo-tube or
hollow tether (79107). An adhesive bleb (79108) is affixed to the outer airway
wall. Adhesive bleb
(79108) may be used alone as an anchor to the outer airway wall or in
combination with barbed
anchor (79102).
[0189] In the embodiments of figures 80A-80C and 81A and 81B, a barbed lead is
anchored to the outer
wall of an airway. The barbed leads are then retracted back through the
channeled bead compressing
the surrounding lung tissue as described in other methods disclosed herein.
The tethers are locked into
their retracted position in the bead when their channels are deformed after
crimping the bead. The
delivery catheter then detaches from the crimped bead at an airway junction
leaving it secured with
the compressed tissue.
[0190] Figures 80A-C illustrate two possible styles of barbed leads. Fig. 80A
depicts a fish-hook style
barb; fig. 80B depicts a "T"-style barb in its delivery position and in fig.
80C a T-style barb is in its
deployed or anchor position. Barbed leads may be made of a shape memory
material enabling its
complying to a delivery position during travel through a delivery lumen such
as a hypotube and self-
deploying to an anchor position when pushed out the tube or after the tube is
removed. Such devices
may be delivered through a hypotube incorporated in the delivery apparatus.
[0191] Figures 81A-B illustrate a "T"-style barbed lead (81112) in an
anchoring system (81111)
comprising a channeled bead (81113) through which a plurality of barbed leads
provided with the
ability to penetrate an airway wall (81114) can be extended and retracted.
This channeled bead is
coupled to a delivery catheter (81115). The channeled bead is configured such
that the bead may be
crimped forcing retracted leads to lock in a fixed position. The channeled
bead also has the capability
to detach (81116) from the delivery catheter. Figure 81B shows this embodiment
positioned inside an
airway at an airway branch (81117) after barbed leads (81112) are anchored
externally to the airway
wall (81118) and prior to retracting the barbed leads.
101921 Figures 82 and 83 represent another embodiment wherein lung volume
reduction is achieved by
extending and looping a circular shape-memory hypotube encasing an alternate
barbed stitching line
outward from a delivery head located within an airway and, penetrating the
airway wall into the
surrounding lung tissue, the conforming shape-memory hypotube returns to a
capture mechanism
located on the delivery head where the distal end of the stitching line may be
secured. Once captured
and secured, the hypotube is removed and the barbed stitching line is
retracted through the delivery
head compressing the gathered lung tissue. The delivery head is detached from
the delivery catheter
after the compression is achieved and left to hold the compressed tissue in
place. The hypo tube may
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additionally comprise electrodes which can be used to map the encased tissue
and direct the capture
mechanism.
[0193] In figure 82A a channeled delivery head (82119) through which a shape
memory hypotube
(82120) may be extended or retracted through delivery channel (82121) is
shown. Capture
mechanism (82122) may be extended and retracted through a second delivery
channel (82123) in the
channeled delivery head. In figure 82B shape memory hypotube (82120) loops
around and allowing
82124 to be captured by capture mechanism (82122). Figure 82C shows a
retracted barbed stitching
line (82124) secured to the capture mechanism after the hypotube has been
retracted. As illustrated
optional electrodes (82131) are comprised on hypotube (82120) and capture
mechanism (82122).
These electrodes allow for both electrical impedance mapping of the surrounded
tissue and provide
feedback to the user relative to the proximity of the capture mechanism to the
hypotube during
capture. Such information can be used to facilitate the user steering the
capture mechanism during
the capture process.
[0194] Figures 82D-F detail the hypotube and stitching line capture process.
In figure 82D hypotube
(82120) is captured. In figure 82E hypotube is removed and barbed stitching
line (82124) is exposed.
In figure 82F the barbed stitching line is secured to the delivery head when
the capture mechanism
(82122) is retracted into the head.
[0195] In figure 83A shape memory hypotube (82120) is extended though an
airway wall and into
surrounding tissue looping back to be captured by the capture mechanism. In
figure 83B the hypotube
has been removed and the secured stitching line (82124) retracted through the
delivery head
compressing the surrounding lung tissue achieving a reduction in lung volume.
Should it be desired
to remove the anchoring system, the stitching line 82124 can be clipped and
the entire anchoring
system removed. This can be performed, for example, if it is desired to reduce
tension that has been
applied to the lung.
[0196] Figure 84 shows a graph of the relationship between load applied to a
distal anchor and the
resulting displacement of that anchor. A first region of the graph is labeled
"Elastic Loading," and is
characterized by a monotonic increase in displacement as additional load is
applied. This indicates
the tissue surrounding the airway maintains mechanical integrity. A second
region of the graph is
labeled "Tearing," and is characterized by an overall drop and or non-
monotonic increase in the load
with increasing displacement. This drop in load is due to tearing in the
airway and or the surrounding
lung tissue in which the anchor is placed. This tearing reduces or completely
eliminates the
mechanical connection between the anchor and the lung tissue targeted for lung
volume reduction.
The inability to apply traction to the extremities of the area targeted for
lung volume reduction due to
tearing limits or reduces the overall effectiveness of the lung volume
reduction procedure. Figure 84
also shows an exemplary point "A" that demonstrates the load that should be
applied for optimal lung
volume reduction. This point is near the maximum load that can be applied
without tearing, but
avoids the actual maximum to ensure no tearing occurs. One way of identifying
an appropriate load
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point A is by correlating it with a maximum modulus value. In such procedures
the tissue is retracted
to a point close to but less than the predetermined maximum modulus value.
[0197] Figure 85 and figure 86 show the impact of emphysematous tissue on the
relationship between
load applied and the resulting displacement of an anchor. In figure 85, anchor
(85125) can be seen to
reside in healthy tissue (85128), anchor (85126) can be seen to reside on the
margin between healthy
tissue (85128) and emphysematous tissue (85129), and anchor (85127) can be
seen to reside
completely within emphysematous tissue (85129). Referring to Fig. 86, anchor
(85125) can be seen
as achieving the highest load prior to the initiation of tearing as a result
of it being placed in healthy
tissue. Anchor (85126) has a lower load prior to tearing because it is engaged
with both healthy and
emphysematous tissue. Anchor (85127) has a very low load prior to tearing
because it is only
engaged with emphysematous tissue, where tearing occurs easily. The
relationship depicted in the
graph of figure 86 illustrates that the maximum load supportable can be
derived from the modulus at
a low displacement. In particular, the more unhealthy tissue contributing to
the load deformation
characteristics measured for a given anchor, the lower both the average
modulus and the modulus
measured at a particular displacement or load, as measured in the elastic
region for that anchor.
Hence one method to predetermine an appropriate load point A is to use the
modulus at relatively low
and safe load or displacement point to predict the target displacement or load
point A.
[0198] In other alternate procedures an anchor may be displaced or loaded to
the point where the
modulus ceases to monotonically increase, or begins to decrease, indicating
the beginning of tissue
failure. In some alternative procedures, the patient can be lowed to heal at
this point for a period of
time as described elsewhere herein, and then the anchor can be further
tightened after that healing
period.
[0199] Figure 87 shows the relationship between torque applied to the tethers
attached to anchors
(85125, 85126, and 85127) described in figure 85. Torque initially increased
with displacement to a
maximum where tearing occurs. Once tearing occurs, the torque stays constant,
or is reduced due to
the additional degrees of freedom caused by the tears.
[0200] Figure 88 shows the torque applied in a tether attached between anchors
as a function of the
number of turns applied to that anchor. Initially, each turn causes only a
modest increase in torque.
Once a sufficient number of turns has been accumulated in the line, no
additional turns can be stored
elastically in the line and the line forms a loop and begins to wrap upon
itself. This point is shown in
figure 88 as the point denoted as "T". Figure 89A shows the line before it has
reached its limit in
number of turns before forming a loop (point "T"). Figure 89B shows the line
having loops in it after
the line has increased past point "T". Of particular interest is that in order
to cause substantial
displacement of the anchors relative to each other, the torque and number of
turns should exceed the
critical point "T", where the slope of the line increases substantially.
102011 Figure 90 is an alternative to the embodiment in figures 1A. Figure 90
illustrates optional
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electrodes (90131) on one or both anchors. The electrodes can be used as
described herein to allow
for electrical impedance (El) measurements as a way of characterizing tissue
electrical impedance. In
these embodiments the one or more tethers comprise a conductive element to
electrically
communicate with the electrodes. In other embodiments electrical impedance
changes between
multiple anchors may be used to indicate appropriate compression or tearing of
tissues between the
multiple anchors. In some embodiments the electrodes can be used to measure
tissue density at the
anchor and measure changes between the anchors as the anchors are drawn closer
to one another. The
anchoring system of figure 90 additionally provides a conical proximal portion
(90132) on the distal
anchor (90005) and a proximal conical section (90133) on the self expanding
proximal anchor
(90006), which facilitates complete collapse, retrieval, and removal of the
anchoring system should it
be desired. Either the proximal anchor or both anchors can be removed if, for
example, it is desired to
reduce a tension that has been applied to the lung, or return the lung towards
its pre-op state.
[0202] Figure 91 presents an exemplary flow chart of possible steps for use in
performing a lung
reduction volume method, examples of which are described herein. Not all steps
need to be
performed, and the order or steps can be modified if desired. A pre-evaluation
step comprising
imaging and or functional tests as described above is performed. Target and/or
probable target tissues
are identified at this stage. Next, a pre-procedure evaluation may be
performed using minimally
invasive techniques such as intra-bronchial ultrasound, local intra bronchial
ventilation
measurements, other characterizations of tissue density or compliance, or any
pre-evaluation
technique. The next step is to implant the anchors. At this point an optional
stepwise delay may be
initiated to allow for a healing response, tissue relaxation, and/or ingrowth.
Next, a sequential
adjustment is performed. This can be followed with a repeat evaluation chosen
from any or any
combination of those previously described. At this point additional anchors
may be desired and the
procedure is re-entered at step "d," an additional stepwise delay may be
initiated and the procedure
re-entered at step "e," or the procedure may be considered complete.
This disclosure incorporates by reference herein the disclosure of U.S. Pat.
No. 6,997,189 and U.S. Pat.
No. 8,282,660. Any of the embodiment therein can be modified to include any of
the features or methods
of use described herein.
[0203] Alternative Embodiments:
[0204] Additional aspects of the disclosure are defined in accordance with the
following exemplary
embodiments:
[0205] 1. A method for reducing the volume of a section of diseased lung
comprising: identifying at least
one section of diseased lung; characterizing a physical quality of the at
least one diseased section of
the lung; determining the location of the at least one diseased section of
lung; endobronchially
delivering an anchoring system to the diseased portion of the lung; the anchor
system capable of,
incremental adjustment to increase or decrease the distance between a proximal
and distal anchor, and
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sustaining said adjustment upon release from a delivery system; adjusting the
system to reduce the
volume of the diseased tissues in the lung.
[0206] 2. The method of embodiment 1 where the section of diseased lung is
emphysematous comprising
hyperinflated tissue.
[0207] 3. The method of embodiment 1 where quality is a measure of tissue
compliance.
[0208] 4. The method of embodiment 3 where tissue compliance is determined
using a medical imaging
means prior to the implantation procedure.
[0209] 5. The method of embodiment 3 where tissue compliance is determined
using an endovascularly
delivered ultrasonic means during the implantation procedure.
[0210] 6. The method of embodiment I where quality is a measure of tissue
density.
[0211] 7. The method of embodiment 6 where tissue density is determined using
a medical imaging
means prior to the implantation procedure.
[0212] 8. The method of embodiment 7 where tissue density is determined using
an endovascularly
delivered ultrasonic means during the implantation procedure.
[0213] 9. The method of embodiment I where the physical quality is used to
determine the maximum
tension to apply to a distal anchor.
[0214] 10. The method of embodiment 9 where the maximum tension to the anchor
is as amount of
determined to sustain no or minimal parenchyma tearing in the tissue
surrounding the anchor.
[0215] 11. The method of embodiment 1 where location is determined via a
medical imaging means prior
to the implantation procedure.
[0216] 12. The method of embodiment 11 where location is characterized as the
tissues bounding and
internal to the boundary of healthy tissue.
[0217] 13. The method of embodiment 11 where delivery comprises placing one or
more distal anchors
within or at the boundary of diseased tissue and placing at least one or more
proximal anchors within
healthy tissue or at the boundary of the healthy tissue.
[0218] 14. The method of embodiment 11 where delivery comprises placing one or
more distal anchors
within diseased tissue and placing at least one or more proximal anchors
within diseased tissue or at
the boundary of the healthy tissue.
[0219] 15. The method of embodiment I actuating the proximal anchor to reduce
the volume of the
diseased section of lung.
[0220] 16. The method of embodiment 15 where actuating reduces the distance
between a proximal and
distal anchor.
[0221] 17. The method of embodiment 15 where actuating causes the tether to
wind on itself.
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102221 18. The method of embodiment 17 delivering multiple anchor systems to a
single diseased section
of lung.
[0223] 19. The method of embodiment ldelivering one or more anchor systems to
multiple diseased
sections of lung.
[0224] 20. The method of embodiment 1 where the magnitude of the tension on an
anchor is
determinable in situ by a medical imaging means.
[0225] 21. The method of embodiment 1 where the any distal anchor may be
released from a proximal
anchor.
[0226] 23. A method for reducing the volume of a section of diseased lung
comprising: endobronchially
delivering an anchoring system to a diseased portion of the lung where the
system is comprised of at
least one proximal anchor and at least one distal anchor; the anchor system
capable of incremental
adjustment to increase or decrease the distance between a proximal and distal
anchor, and sustaining
said adjustment upon release from a delivery system; actuating the system to
reduce the volume of the
diseased tissues in the lung; allowing a period of time to pass and then
readjusting the distance
between the at least one proximal anchor and at least one distal anchors.
[0227] 24. The method of embodiment 24 the period of time sufficient to allow
for any or any
combination of the following: tissue relaxation; tissue ingrowth into the
anchors; healing response in
the volume reduced tissue.
[0228] 25. The method of embodiment 24 the period of time in the range of 5
minutes to greater than 1
year.
[0229] 26. The method of embodiment 24 identifying at least one section of
diseased lung prior to
delivery of the anchoring system.
[0230] 27. The method of embodiment 24 characterizing a physical quality of
the at least a portion of one
diseased section of the lung.
[0231] 28. The method of embodiment 24 determining the location of the at
least one diseased section of
lung.
[0232] 29. The method of embodiment 24 the anchoring system comprising
multiple distal anchors
[0233] 30. The method of embodiment 24 delivering multiple anchor systems to a
single diseased section
of lung.
[0234] 31. The method of embodiment 24 delivering anchor systems to multiple
diseased sections of
lung.
[0235] 33. The method of embodiment 24 actuating is adjusting the distance
between at least a proximal
and distal anchor.
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[0236] 34. The method of embodiment 24 perform any preplaning or in situ study
between adjustments.
[0237] 35. The method of embodiment 24 to prevent pnuemothorax.
[0238] 36. The method of embodiment 24 where the magnitude of the tension on
an anchor is
determinable in situ by a medical imaging means.
[0239] 37. A method for reducing the volume of a section of diseased lung
comprising: identifying at
least one section of diseased lung using an endobronchial ultrasound device to
determine a physical
quality of the lung tissue in the at or near the diseased tissue;
endobronchially delivering an anchoring
system to a diseased portion of the lung where the anchor system comprising at
least one proximal
anchor and at least one distal anchor; the system capable of incremental
adjustment to increase or
decrease the distance between a proximal and distal anchor, and sustaining
said adjustment upon
release from a delivery system; adjusting the system to reduce the volume of
the diseased tissues in
the lung;
[0240] 38. The method of embodiment 37 where the physical quality is
compliance
[0241] 39. The method of embodiment 37where the physical quality is a measure
of the loading capacity
an anchor.
[0242] 40. The method of embodiment 37where the loading capacity of the anchor
is a measure of the
amount of load the anchor can sustain without parenchyma tearing.
[0243] 41. A method for reducing the volume of a section of diseased lung
comprising: endobronchially
delivering an anchoring system to the diseased portion of the lung where the
system comprises at
least one proximal anchor and at least one distal anchor, the anchor system
capable of incremental
adjustment to increase or decrease the distance between a proximal and distal
anchor, and sustaining
said adjustment upon release from a delivery system; and adjusting the system
to reduce the volume
of the diseased tissues in the lung.
[0244] 42. The method of embodiment 41 where the system is adjusted to a
predetermined tension on the
anchor.
[0245] 43. The method of embodiment 41where the predetermined tension is
characterized by any one or
combination of the following: medical imaging system, endobronchial US, a
local functional
measurement.
[0246] 44. The method of embodiment 41 adjusting is reducing or increasing the
distance between at
least a proximal and distal anchor.
[0247] 45. The method of embodiment 41 incrementally adjusting multiple distal
anchors such that the
tension on each distal anchor never exceeds a predetermined value.
[0248] 46. The method of embodiment 45 incrementally adjusting anchors in less
diseased tissue prior to
adjusting anchors in more diseased tissues.
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102491 47. The method of embodiment 45 comprising simultaneous treatment of an
entire lung by
incrementally adjusting multiple distal anchors connected to multiple proximal
anchors
[0250] 48. A method for reducing the volume of a section of diseased lung
comprising: endobronchially
delivering a lung volume reduction system to a portion of the lung; the lung
volume reduction system
comprised of an anchoring system comprising at least one proximal anchor, at
least one distal anchor,
and a means for monitoring a ventilation parameter at a target bronchi or
bronchiole; the anchor
system capable of incremental adjustment to increase or decrease the distance
between a proximal
and distal anchor; and sustaining said adjustment upon release from a delivery
system; determining
from the monitored ventilation parameters an implant location for a proximal
anchor; adjusting the
system to reduce the volume of the diseased tissues in the lung.
[0251] 49. A method for reducing the volume of a section of diseased lung
comprising: endobronchially
delivering an anchoring system to the diseased portion of the lung where the
anchor system comprises
at least one proximal anchor and at least one distal anchor; the anchor system
capable of incremental
adjustment to increase or decrease the distance between a proximal and distal
anchor, and sustaining
said adjustment upon release from a delivery system; adjusting the system to
reduce the volume of the
diseased tissues in the lung.
[0252] 50. The method of embodiment 49 where the system is incrementally
adjusted to a predetermined
tension on the anchor.
[0253] 51. The method of embodiment 50 where the predetermined tension is
characterized by any one
or combination of the following: medical imaging system; endobronchial US; and
a local functional
measurement.
[0254] 52. The method of embodiment 50 adjusting is reducing or increasing the
distance between at
least a proximal and distal anchor.
[0255] 53. The method of embodiment 50 incrementally adjusting multiple distal
anchors such that the
tension on each distal anchor never exceeds a predetermined value.
[0256] 54. The method of embodiment 53 incrementally adjusting anchors in less
diseased tissue prior to
adjusting anchors in more diseased tissues.
[0257] 55. The method of embodiment 53 simultaneous treatment of an entire
lung by incrementally
adjusting multiple distal anchors connected to multiple proximal anchors.
[0258] Alternative Embodiments:
[0259] Additional aspects of the disclosure are defined in accordance with the
following exemplary
embodiments:
[0260] 56. A device for reducing the volume of a lung, comprising: a
distal anchor, a proximal
anchor, and a tether extending between the distal and proximal anchors, the
device configured so that
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the distance between the anchors measured along the tether can be increased or
decreased and
maintained after release of a delivery device.
[0261] 57. The device of embodiment 56 wherein the device is further
configured so that the
distance between the anchors can be further increased or decreased after the
device has been released
from a delivery device.
[0262] 58. The device of any of embodiments 56-57 wherein the device
further comprises a
tensioning controller that interfaces with the tether, the tensioning
controller configured to be actuated
to increase or decrease the distance between the proximal and distal anchors.
102631 59. The device of any of embodiments 56-58 wherein a tether actual
length between the
anchors stays the same.
102641 60. The device of any of embodiments 56-59 wherein the tether is
adapted to be reconfigured
such that the distance measured along the tether between the anchors can be
reduced.
[0265] 61. The device of any of embodiments 56-60 wherein only a portion of
the tether is
configured to be reconfigured.
[0266] 62. The device of any of embodiments 56-61 wherein the tether is
configured to wind up on
itself to decrease the distance between the anchors.
[0267] 63. The device of any of embodiments 56-62 wherein the distal anchor
is disposed at a distal
end of the device, the proximal anchor disposed at a proximal end of the
device, and the device does
not include any other anchors disposed between the distal and proximal
anchors.
[0268] 64. The device of any of embodiments 56-63 wherein the distal and
proximal anchors are
expandable.
[0269] 65. The device of any of embodiments 56-64 wherein at least one of
the distal and proximal
anchors has an electrode thereon.
102701 66. The device of any of embodiments 56-65 wherein the device is
configured so that as the
distance between anchors changes, a tether axis remains in the same direction.
102711 67. The device of any of embodiments 56-66 wherein the axis remains
in the same direction
even though the tether changes configuration.
102721 68. The device of any of embodiments 56-67 wherein the device is
configured so that as the
distance between anchors changes, the rotational orientation, out of a plane
comprising the tether
axis, of the distal anchor stays the same relative to the proximal anchor.
[0273] 69. The device of any of embodiments 56-68 wherein the proximal
anchor is configured to be
collapsed and removed from the lung after it has been expanded towards an
expanded configuration.
102741 70. The device of any of embodiments 56-69 wherein the distal anchor
is configured to be
collapsed and removed from the lung after it has been expanded towards an
expanded configuration.
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