Note: Descriptions are shown in the official language in which they were submitted.
APPARATUS AND METHOD COMPRISING AN EXPANDABLE BALLOON OR
MEMBER FOR TREATING OBSTRUCTIONS WITHIN BODY LUMENS
FIELD OF THE INVENTION
The present invention relates generally to apparatus for treating obstructive
material
and/or other obstructions within a body lumen of a patient, e.g., within a
tubular graft, aorto-
venous fistula, blood vessel, and the like. More particularly, the present
invention relates to
apparatus, e.g., balloon catheters, for infusing fluids into a body lumen, for
removing or
otherwise capturing thrombus or other obstructive material within a body
lumen, and/or for
dilating a body lumen, and to methods for making and using such apparatus.
BACKGROUND
Flow within a blood vessel or other body lumen within a patient's vaseulature
may
become constricted or ultimately interrupted for a variety of reasons. For
example, a vessel
may gradually narrow due to inflammation and/or cell proliferation. In
addition, thrombus
may form due to such narrowing or other flow problems within a vessel.
For example, an aorto-venous graft may be implanted in an arm of a patient
experiencing kidney failure, e.g., to facilitate dialysis treatment. Such
grafts may be a fistula
formed directly in the patient's body, e.g., through tissue between an
adjacent artery and vein
or other vessels, may be a xenograft implanted between two vessels, or may be
a synthetic
graft. Such grafts only have a limited life cycle due to inflammation,
thrombus formation, and
the like. Once such a graft becomes sufficiently occluded or otherwise
deteriorates, a new
graft must be implanted at a new location for subsequent treatment.
Accordingly, apparatus and methods for removing material from aorto-venous
grafts, blood vessels, or other body lumens and/or otherwise treating body
lumens would
be useful.
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SUMMARY
The present invention is directed to apparatus for treating a body lumen of a
patient,
e.g., a tubular graft, aorto-venous fistula, blood vessel, and the like. More
particularly, the
present invention is directed to apparatus for infusing fluids into a body
lumen, for removing
or otherwise capturing thrombus or other obstructive material within a body
lumen, and/or for
dilating a body lumen, and to methods for making and using such apparatus.
In accordance with a first embodiment, an apparatus is provided for treating a
body
lumen that is operable in different modes to perform various functions, e.g.,
possibly reducing
the number of device exchanges during a procedure. For example, the apparatus
may include
a shaft including a proximal end, a distal end sized for introduction into a
body lumen, a
lumen extending therebetween, and a balloon on the distal end having an
interior
communicating with the lumen. The apparatus may also include a valve on the
distal end of
the shaft that selectively opens or closes an outlet communicating with the
lumen. With the
valve open, fluid introduced into the lumen may exit the outlet into a body
lumen beyond the
distal end. With the valve closed, fluid introduced into the lumen may expand
the balloon from
a contracted condition to an expanded condition, e.g., a cylindrical shape for
dilating an
obstruction within a body lumen or a bulbous shape for removing material
within the body
lumen. Optionally, the valve may include a stop that may be extended to push a
distal end of
the balloon, e.g., to stretch or otherwise reduce a profile of the balloon
and/or otherwise
facilitate introduction into a patient's body.
In addition or alternatively, the apparatus may include an actuator for
axially
compressing the balloon, and the balloon may be configured to expand from the
contracted
condition to an expanded helical shape when axially compressed. For example,
the actuator
may include an inner member within the shaft that is coupled to a distal end
of the balloon, and
a helical member may extend around the inner member within the balloon. When
the inner
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member is directed proximally or otherwise actuated, the helical member may be
compressed
and consequently expand radially outwardly, thereby expanding the balloon to
the expanded
helical shape. The inner member may be extended distally to extend and return
the balloon back
towards the contracted condition, e.g., after using the balloon in the
expanded helical shape to
remove material within a body lumen.
In accordance with another embodiment, an apparatus is provided for treating a
body lumen that includes an elongate tubular member including a proximal end,
a distal
end, and a first lumen extending between the proximal and distal ends; an
expandable
balloon including a proximal end secured to the tubular member distal end, and
a distal end
including an outlet, the balloon including an interior communicating with the
first lumen
and the balloon outlet; and an elongate member slidably disposed within the
first lumen.
The elongate member may include a proximal end adjacent the tubular member
proximal end,
and a distal end extending from the balloon outlet. The balloon and elongate
member may
include cooperating features providing a valve for selectively opening and
closing the
balloon outlet. For example, a sealing member on the distal end of the
elongate member
sized to be engaged with the balloon distal end to substantially seal the
outlet from fluid
flow.
The elongate member may be movable between a first position wherein the
sealing
member is spaced apart from the balloon outlet such that fluid introduced
through the first
lumen passes through the balloon interior and out the balloon outlet, and a
second position
wherein the sealing member substantially seals the balloon outlet such that
fluid introduced
through the first lumen enters the balloon interior to expand the balloon.
Optionally, the apparatus may include a helical member including a first end
coupled to
the tubular member distal end and a second end coupled to the elongate member
distal end, the
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helical member extending helically around the elongate member within the
balloon interior.
The elongate member may be movable to a third position in which the elongate
member distal
end is directed towards the tubular member distal end to cause the helical
member to compress
axially and expand radially outwardly, thereby expanding the balloon to an
expanded helical
shape.
In accordance with yet another embodiment, an apparatus is provided for
treating a
body lumen that includes an outer tubular member including a proximal end, a
distal end, and
a first lumen extending between the proximal and distal ends; an inner member
slidably
disposed within the first lumen; and an expandable balloon including a
proximal end secured
to the outer member distal end, an interior communicating with the first lumen
and a balloon
outlet. The inner member includes a distal end extending from the balloon
outlet, and carrying
one or more sealing members. A helical member includes a first end coupled to
the outer
member distal end and a second end coupled to the inner member distal end, the
helical
member extending helically around the inner member within the balloon
interior.
The inner member may be movable relative to the outer member for deploying the
balloon in multiple modes. For example, the inner member may be movable from a
first
position wherein the sealing member is spaced from the balloon outlet such
that fluid
introduced through the first lumen passes through the balloon interior and out
the balloon
outlet, and a second position wherein the sealing member substantially seals
the balloon outlet
such that fluid introduced through the first lumen enters the balloon interior
to expand the
balloon. In addition or alternatively, the inner member may be movable from
the first position
to a third position in which the inner member distal end is directed
proximally towards the
outer member distal end to cause the helical member to expand radially
outwardly, thereby
expanding the balloon to an expanded helical shape.
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In accordance with still another embodiment, an apparatus is provided for
treating a
body lumen that includes an outer tubular member including a first lumen
extending between
proximal and distal ends thereof, an inner member slidably disposed within the
first lumen, and
an expandable balloon comprising a proximal end secured to the outer member
distal end, and
a distal end coupled to a distal end of the inner member. The balloon includes
an interior
communicating with the first lumen such that inflation media may be delivered
through the
first lumen into the balloon interior for expanding the balloon radially
outwardly from a
contracted condition to an expanded condition, e.g., defining a cylindrical or
bulbous shape.
The inner member may be movable axially relative to the outer member for
causing the
balloon to compress axially and expand radially from the contracted condition
to an expanded
helical shape.
For example, the apparatus may include a helical member extending helically
around
the inner member within the balloon interior, and including a first end
coupled to the outer
member distal end and a second end coupled to the inner member. When the inner
member is
moved axially, the helical member may be compressed axially and expanded
radially
outwardly, thereby directing the balloon to the expanded helical shape.
Optionally, the inner member may include a second lumen extending between the
inner member proximal and distal ends, e.g., for receiving a guidewire or
other rail. Thus,
the apparatus may be advanced over a guidewire loaded through the second
lumen. Once the
balloon is disposed within a target body lumen, the inner member may be
directed to one or
more of the first, second, and/or third positions, as desired, to perform
various functions
using the apparatus, e.g,, without having to remove the apparatus and/or
introduce another
device into the body lumen.
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In accordance with another embodiment, a method is provided for treating a
body
lumen of a patient using a balloon apparatus that includes an elongate shaft
including a first
lumen extending between proximal and distal ends thereof, and a balloon
carried on the distal
end of the shaft that includes an outlet and an interior communicating with
the first lumen and
the outlet. The distal end of the shaft may be introduced into a body lumen
with the balloon in
a contracted condition, and positioned relative to obstructive material within
the body lumen
that is to be removed. Once positioned adjacent the obstructive material, the
balloon may be
expanded from the contracted condition to an expanded helical shape, and the
distal end of the
apparatus may be directed along the body lumen with the balloon in the
expanded helical
shape to remove the material from the body lumen. For example, the helical
shape of the
balloon may enhance dislodging material adhered to a wall of the body lumen.
Optionally, the
balloon may include one or more features, e.g., edges, grooves, and the like,
to facilitate
separating adherent material from the wall of the body lumen. If desired, the
balloon may be
returned to the contracted condition, moved to a new location within the body
lumen, and
again expanded to the expanded helical shape to remove additional material
within the body
lumen. Once sufficient material is removed, the balloon may be returned to the
contracted
condition.
Before or after removing obstructive material from the body lumen, inflation
media
may be introduced through the first lumen into the balloon interior to expand
the balloon
from the contracted condition to an expanded condition, e.g., defining a
substantially
cylindrical shape. The balloon may be expanded to dilate an obstruction,
lesion or otherwise
treat a wall of the body lumen. After dilating the body lumen, the inflation
media may be
withdrawn from the balloon interior through the first lumen to collapse the
balloon back
towards the contracted condition.
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If the apparatus includes a valve adjacent the balloon for opening or closing
an
outlet communicating with the first lumen and the balloon interior, the valve
may be
closed before inflating the balloon. Optionally, at any time during the
procedure, the
valve may be opened, e.g., to infuse fluid into the body lumen, e.g., for
diagnostic and/or
therapeutic purposes. After expanding the balloon one or more times, e.g., to
the
cylindrical shape and/or helical shape, the distal end of the apparatus may be
removed
from the body lumen and/or entirely from the patient's body with the balloon
in the
contracted condition.
In one embodiment of the present invention, the apparatus includes an elongate
tubular member including a proximal end, a distal end sized for Introduction
into a body
lumen, and an aspiration lumen extending between the proximal and distal ends.
The
apparatus also includes an elongate guide member extending from the distal end
and
terminating in a distal tip and a fragmentor device. The guide member is
reciprocal relative
to the tubular member such that the distal tip is moved towards and away from
the tubular
member distal end. The fragmentor device includes a plurality of loops coupled
sequentially to one another. A first loop is coupled to the tubular member
distal end and a
last loop is coupled to the guide member such that, as the guide member is
reciprocated, the
loops are directed between a low profile extending generally along the guide
member and a
large profile in which the loops extend transversely relative to the guide
member.
Other aspects and features of the present invention will become apparent from
consideration of the following description taken in conjunction with the
accompanying
drawings.
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BRIEF DESCRIPTION OF THE DRAWINGS
It will be appreciated that the exemplary apparatus shown in the drawings are
not necessarily
drawn to scale, with emphasis instead being placed on illustrating the various
aspects and features of the
illustrated embodiments.
FIG. 1 is a side view of a first exemplary embodiment of an apparatus
including a balloon for
treating a body lumen, the apparatus operable in a first mode for minimizing a
profile of the apparatus
for introduction into the body lumen, a second mode for infusing fluid into
the body lumen, and a third
mode for removing material within the body lumen.
FIG. 2 is a side view of the apparatus of FIG. 1 in the first mode for
minimizing a profile of
the apparatus for introduction into a body lumen.
FIG. 3 is a side view of the apparatus of FIG. 1 in the second mode for
infusing fluid into a
body lumen.
FIG. 4 is a side view of the apparatus of FIG. 1 in the third mode in which
the balloon is
expanded for removing material within a body lumen.
FIG. 5 is a side view of the apparatus of FIGS. I and 4 in the third mode,
showing a size of
the balloon being increased to facilitate removing material within a body
lumen.
FIGS. 6A-6D arc side view details of the apparatus of FIGS. 1-5, showing
alternative
configurations for the balloon.
FIG. 7 is a side view of a second exemplary embodiment of an apparatus
including a
balloon for treating a body lumen, the apparatus operable in a first mode for
infusing fluid into the
body lumen, a second mode for dilating an obstruction within the body lumen,
and a third mode for
removing material within the body lumen.
FIGS. 7A-7H are cross-sections of the balloon of the apparatus of FIG. 7,
showing
alternate constructions for integrally forming a helical member into the
balloon.
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FIG. 8 is a side view of a third exemplary embodiment of an apparatus
including a
balloon for treating a body lumen, the apparatus operable in a first mode for
dilating an
obstruction within the body lumen, and a second mode for removing material
within the body
lumen.
FIGS. 9A-9G are cross-sections of a body lumen showing exemplary methods for
removing thrombus or other obstructive material from the body lumen and/or for
dilating an
obstruction within the body lumen using the apparatus of FIG. 7 or 8.
FIGS. 10A-10D are cross-sectional views of alternative embodiments of balloon
structures that may be provided on the apparatus of FIG. 8 to enhance removal
of adherent
material within a body lumen.
FIG. 11 is a side view of an alternative embodiment of the apparatus of FIG. 7
or 8,
including an obstruction removal balloon having different size coils in
different regions of the
balloon.
FIGS. 12 and 13 are cross-sectional views of a patient's body, showing methods
for
treating an arterio-venous dialysis graft using the apparatus of FIG. 11.
FIG. 14 is a side view of another alternative embodiment of the apparatus of
FIG. 11,
including a dilation balloon adjacent the obstruction removal balloon.
FIGS. 15A and 15B are alternative embodiments of coil structures that may be
provided
within the balloon of any of the apparatus of FIGS. 8-14.
FIG. 16 is a side view of a fourth exemplary embodiment of an apparatus
including a
balloon for treating a body lumen, the apparatus operable in a first mode for
removing material
within the body lumen, and in a second mode for dilating an obstruction within
the body lumen.
FIGS. 17A-17D are side views of the apparatus of FIG. 10, showing operation of
the
apparatus between an initial delivery configuration (FIG. 1 1A), the first
mode for removing
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material within a body lumen (FIGS. 11B and 11C), and the second mode for
dilating an obstruction
within a body lumen (FIG. 11D).
FIG. 18 is a side view of a distal end of another embodiment of a balloon
catheter
including a plurality of difference size balloons and a valve member for
selectively delivering
inflation media to one of the balloons.
FIG. 19 is a side view of an exemplary embodiment of an apparatus for removing
obstructive
material within a body lumen.
FIG. 20 is a detail of a handle of the apparatus of FIG.19.
FIGS. 21A and 21B are details of a distal end of the apparatus of FIG. 19,
showing lumen
clearing elements being actuated between a low profile and a large profile,
respectively.
FIGS. 22A-22F are cross-sectional views of a body lumen, showing a method for
removing
obstructive material within the body lumen using the apparatus of FIGS. 18-
21B.
FIG.23A is a perspective view of an apparatus, similar to that shown in FIG.
7, including a
first exemplary embodiment of a handle for actuating the apparatus.
FIG. 23B is a cross-sectional detail of components of a rotary knob control on
the handle of
FIG. 23A with a housing of the handle removed to show internal components.
FIG. 24A is a perspective view of another apparatus, similar to that shown in
FIG. 7,
including a second exemplary embodiment of a handle for actuating the
apparatus.
FIG. 24B is a cross-sectional detail of components of a slider control on the
handle of FIG.
24A with a housing of the handle removed to show inter components;
FIG. 24C is a detail of an alternate slider control, similar to that shown in
FIGS. 24A and
24B, including visual indicators identifying actuatable positions of the
apparatus.
FIG. 25A is a perspective view of yet another apparatus, similar to that shown
in FIG. 7,
including a third exemplary embodiment of a handle for actuating the
apparatus.
FIG. 25B is a cross-sectional detail of components of a rotary wheel control
on the handle
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of FIG. 25A with a housing of the handle removed to show internal components.
FIG. 26A is a perspective view of still another apparatus, similar to that
shown in FIG. 7,
including a fourth exemplary embodiment of a handle for actuating the
apparatus.
FIG. 26B is a cross-sectional detail of components of a squeeze control on the
handle of
FIG. 26A with a housing of the handle removed to show internal components.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
Turning to the drawings, FIGS. 1-5 show a first exemplary embodiment of an
apparatus 10
for treating a body lumen, e.g., for infusing fluid into a body lumen and/or
for removing thrombus,
objects, and/or obstructive material from within a body lumen, such as a blood
vessel, aorta-venous
fistula, tubular graft, and the like (not shown). Generally, the apparatus 10
includes a catheter,
sheath, or other tubular outer member 20, a core wire, shaft, or other
elongate inner member 30, and
an expandable balloon 50 carried by the inner and/or outer members 20, 30. The
apparatus 10 may
be operable in multiple modes, for example, to perform various treatments or
other functions within a
body lumen, e.g., to reduce or eliminate the need to exchange multiple devices
during a procedure
within a body lumen. For example, the apparatus 10 may be operable in a first
mode for minimizing
a profile of the apparatus 10, e.g., to facilitate introduction into a
patient's body (FIG. 2), a second
mode for infusing fluid into a body lumen (FIG. 3), and a third mode for
removing material within a
body lumen (FIGS. 4 and 5), as described further below.
As best seen in FIG. 1, the outer member 20 includes a proximal end 22, a
distal end 24 sized
for introduction into a body lumen, and a first lumen 26 extending
therebetween. The outer member
20 may have a substantially uniform construction along its length, or
alternatively, the construction
may be varied. For example, a proximal portion of the outer member 20 may be
substantially rigid or
semi-rigid to facilitate advancement of the apparatus 10 from the proximal end
22 and/or a distal
portion of the outer member 20 may be flexible, e.g., to facilitate bending
and/or advancement
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through tortuous anatomy without substantial risk of kinking or buckling. In
exemplary
embodiments, the outer member 20 may be formed from materials such as metal,
plastic, e.g., PEEK,
Grilamed L25, and the like, or composite materials. The outer member 20 may
have a length between
about thirty and one hundred thirty centimeters (30-130 cm) and an outer
diameter between about 1.2
to 2.0 millimeters, and the first lumen 26 may have a diameter between about
1.0 and 1.8 millimeters.
The inner member 30 also includes a proximal end 32, a distal end 34, and,
optionally, may
include a second lumen 36 extending between the proximal and distal ends 32,
34, which may be sized
to slidably receive a guide wire, or other rail (not shown) therethrough,
e.g., having a diameter
between about 0.3 and 1.0 millimeter. The inner member 30 is sized to be
slidably received within the
first lumen 26 of the outer member 20, e.g., such that an annular space is
defined between the outer
and inner members 20, 30 for passing one or more fluids therethrough, as
described further below.
The inner member 30 may have a length relative to the outer member 20 such
that the inner member
proximal end 32 is received within or extends proximally beyond the outer
member proximal end 22
and the inner member distal end 34 extends distally beyond the outer member
distal end 24, e.g.,
through the balloon 50, as described further below.
The balloon 50 includes a proximal end 52 coupled to the outer member distal
end 24, a distal
end 54 defining an outlet 58, and an interior 56 communicating with the first
lumen 26 and the outlet
58. The proximal end 52 of the balloon 50 may be attached or otherwise secured
to the distal end 24 of
the outer member 20 to provide a fluid-tight connection, e.g., by one or more
of bonding with
adhesive, interference fit, sonic welding, fusing, engagement with a
surrounding sleeve or other
connector (not shown), and the like.
The distal end 34 of the inner member 30 may extend through the distal end 54
of the
balloon 50, e.g., such that the outlet 58 defines an annular passage between
the distal end 54 of the
balloon 50 and the distal end 34 of the inner member 30. The size of the
outlet 58 may be
substantially the same as the size of the first lumen 26, or alternatively,
the outlet 58 may be larger or
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smaller than the first lumen 26, as desired, depending on the desired degree
of friction or resistance to
fluid flow through the outlet 58. For example, with the outlet 58 open to
allow fluid flow, the
resistance to fluid flowing through the outlet 58 may be substantially less
than the resistance of the
balloon 50 to expansion, such that the fluid preferentially flows through the
outlet 58, rather than
expanding the balloon 50, as described further below.
As shown in FIG. 1, the distal end 54 of the balloon 50 may be integrally
formed with the
main wall of the balloon 50 (defining the interior 56), and, optionally the
proximal end 52 of the
balloon 50. For example, the balloon 50 and its proximal and distal ends 52,
54 may be molded,
blown, or otherwise formed from a single tubular section of material.
Optionally, the main wall of the
balloon 50 may be relatively thin compared to the distal end 54, e.g., such
that the distal end 54 of the
balloon 50 maintains its original size and/or shape as the balloon 50 is
expanded.
For example, the distal end 54 of the balloon 50 may be sufficiently thick
and/or rigid to
provide a sealing ring on the distal end 54. Optionally, the distal end 54 of
the balloon 50 may
include one or more additional features, e.g., surrounding or otherwise
defining the outlet 58 and/or
reinforcing the distal end 54. For example, the distal end 54 may include a
collar or sleeve (not
shown, see, e.g., sleeve 155 shown in FIG. 7), within or around the distal end
54 e.g., attached or
otherwise secured to the distal end 54, e.g., by bonding with adhesive,
interference fit, sonic welding,
fusing, and the like.
The balloon 50 may be formed from elastic material, e.g., to provide a
compliant or semi-
compliant balloon that may be expanded to a variety of sizes and/or shapes,
e.g., based on the amount
of fluid and/or pressure within the interior 54 of the balloon 50 and/or the
relative position of the inner
member 30, as described further below. Alternatively, the balloon 50 may be
formed from
substantially inelastic material, e.g., to provide a non-compliant balloon
that expands to a
predetermined size when inflated independent of pressure (once a minimum
volume and/or pressure is
introduced to achieve the predetermined size). Such a non-compliant balloon 50
may expand to the
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predetermined size even if inflated to relatively high pressures, e.g., until
the balloon 50 bursts or
otherwise ruptures, e.g., at pressures of ten atmospheres, twenty atmospheres,
thirty atmospheres, and
the like.
One or more sealing members 38 may be carried on the inner member distal end
34, e.g., such
that the sealing member(s) 38 are movable relative to the balloon 50 as the
inner member 30 is moved,
e.g., for selectively opening and closing the outlet 58 of the balloon 50 to
provide a valve, as described
further below. The sealing member(s) 38 may be formed from flexible materials,
e.g., which may
enhance engagement with the balloon distal end 54, such as elastomeric
materials, e.g., silicone, or
other plastics, e.g., PEBAX.
As best seen in FIG. 1, a first sealing member 38a may be provided on the
inner member 30
proximal to or otherwise adjacent a second sealing member 38b. The sealing
member(s) 38 may be
disposed adjacent a distal tip 35 of the inner member 30 or may extend beyond
the distal tip 35. The
distal tip 35 (or the sealing member extending beyond the distal tip 35) may
be substantially
atraumatic, e.g., rounded, softened, provided with a "J" tip, and the like
(not shown), to facilitate
advancement of the apparatus 10 within a patient's body without substantial
risk of the distal tip 35
puncturing or otherwise damaging walls of body lumens through which the distal
tip 35 passes.
The sealing member(s) 38 may have a size, e.g., outer diameter, that is larger
than the distal
end 54 of the balloon 50, e.g., larger than the inner diameter of the outlet
58. As shown in FIG. 1,
the sealing members 38 are spaced apart sufficiently from one another such
that the distal end 54 of
the balloon 50 is free floating between the sealing members 38. When the inner
member 30 is
directed axially, one of the sealing members 38 may engage or otherwise
contact the distal end 54
of the balloon 50. The sealing member(s) 38 may have tapered shapes to
facilitate seating or other
engagement by the sealing member(s) 38 with the distal end 54.
For example, with additional reference to FIG. 2, the inner member 30 may be
directed
distally to a first or distal position wherein the first sealing member 38a
pushes or otherwise
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contacts the distal end 54, and the second sealing member 38b is spaced from
the balloon outlet 58.
As shown, the inner member 30 may be advanced distally to cause the first
sealing member 38a to
push the distal end 54. Because the outer diameter of the first sealing member
38a is larger than
inner diameter of the distal end 54, the first sealing member 38a pushes the
distal end 54 of the
balloon 50 away from the proximal end 52tie, thereby stretching the balloon
50. This configuration
may minimize or otherwise reduce the profile of the balloon 50, e.g., to
facilitate introduction into a
patient's body. In this first position, the first sealing member 38a may
substantially seal the outlet
58, although alternatively, the first sealing member 38a may include one or
more axial grooves or
other features that allow at least some fluid to pass through the outlet 58
even when the first sealing
member 38a is seated or pushing against the distal end 54.
Turning to FIG. 3, the inner member 30 may be directed axially to a second
position, e.g.,
proximal to the first position, such that the distal end 54 of the balloon 50
is disposed between the
sealing members 38a, 38b and the outlet 58 is substantially open. Thus, fluid
introduced through the
first lumen 26 of the outer member 20 may pass through the balloon interior 56
and exit through the
outlet 58, e.g., between the balloon distal end 54 and inner member distal end
24 into the body lumen
beyond the distal tip 35.
As shown in FIG. 4, the inner member 30 may also be directed proximally to a
third position,
e.g., proximal to the second position, in which the second sealing member 38b
engages the distal end
54 of the balloon 50, thereby substantially sealing the outlet 58 from fluid
flowtherethrough. Thus,
any fluid introduced through the first lumen 26 enters the balloon interior 56
and expands the balloon
50. Optionally, as shown in FIG. 5, once the balloon 50 is expanded, the inner
member 30 may be
directed further proximally, e.g., to an indefinite number of positions
wherein the second sealing
member 38b continues to seal the outlet 58, and the size and/or shape of the
expanded balloon 50
may be changed. For example, as shown in FIG. 4, with the inner member 30 in
the third position,
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the balloon 50 may be inflated to an elliptical or generally spherical shape,
e.g., by delivering a
predetermined volume of fluid into the interior 56 of the balloon 50. If the
balloon 50 is compliant,
one of a range of desired volumes may be delivered into the interior 56 to
expand the balloon 50 to a
desired diameter.
With further reference to FIG. 5, thereafter, as the inner member 30 is
directed proximally
further, the distal end 54 of the balloon 50 (captured between the sealing
members 38) is also
directed proximally, i.e., towards the proximal end 52 of the balloon 50,
thereby compressing the
balloon 50 axially and expanding the balloon 50 further.
As shown in FIG. 6A, the balloon 50 wall may have a substantially uniform wall
thickness
between the proximal and distal ends 52, 54. Thus, when the balloon is
compressed, as shown in FIG. 5,
the proximal and/or distal ends 52, 54 of the balloon 50 may at least
partially evert into the interior 56 of the
balloon 50. Thus, the wall of the balloon 50 may fold over onto the outside of
the proximal and/or distal
ends 52, 54 as the inner member 30 is directed proximally from the third
position.
Alternatively, as shown in FIG. 6B, the thickness of the balloon 50' may be
reduced along
its length, e.g., thinning from the proximal and distal ends 52,' 54' towards
a central region 55' of the
balloon 50.' Thus, the regions of the balloon 50' immediately adjacent the
proximal and distal ends
52, 54' may be relatively rigid compared to the central region 55: When the
balloon 50' is
compressed after expansion, the regions immediately adjacent the proximal and
distal ends 52,' 54'
may resist the balloon 50' everting and the thinner central region 55' may
expand to a greater
diameter compared to the balloon 50 of FIG. 6A.
In further alternatives, shown in FIGS. 6C and 6D, the regions of the balloon
50," 50"
immediately adjacent the proximal and/or distal ends 52," 54" or 52," 54" may
be reinforced
further, e.g., including additional materials, to reinforce the base of the
balloon 50," 50" to reduce
everting and/or otherwise preferentially control expansion of the balloon 50,"
50." For example, in
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FIG. 6C, composite materials 53" have been embedded or otherwise provided in
the balloon material
adjacent the proximal and distal ends 52," 54," while in FIG. 6D, an
additional layer of material 53"
has been added, which may be the same material or different material than the
rest of the balloon
50." The layer may be attached to the balloon 50" similar to the materials and
methods described
elsewhere herein for attaching the balloon 50" to the outer member 20.
Returning to FIG.1, a handle or hub 60 may be coupled to or otherwise provided
on the
proximal end 22 of the outer member 20, e.g., for manipulating the outer
member 20 and/or the entire
apparatus 10. The handle 60 may have an ergonomic shape, e.g., to facilitate
holding and/or
manipulating the handle 60, and including one or more controls or actuators
for actuating the
components of the apparatus 10. For example, as shown, a pull handle 62 may be
provided adjacent
the handle 60 that is coupled to the inner member 30. Thus, to move the inner
member 30 to the
various positions described above, the pull handle 62 may be pushed or pulled,
e.g., pushed distally to
direct the inner member 30 to the first position shown in FIG. 2, and pulled
proximally to direct the
inner member 30 to the second and third (or further proximal) positions, shown
in FIGS. 3-5.
Alternatively, similar to the embodiments shown in FIGS. 11 and 14 a slider
actuator (not shown)
may be provided on the handle 60 that is coupled to the inner member 30 for
directing the inner
member 30 axially relative to the handle 60 and outer member 20. In a further
alternative, a wheel or
other actuator may be provided for directing the inner member 30 axially
relative to the outer
member 20.
The pull handle 62 and/or inner member 30 may be biased to one of the
positions shown in
FIGS. 2-5, e.g., by one or more springs or other biasing mechanisms (not
shown) within the handle
60. For example, the inner member 30 may be biased to the second (infusion)
position, but may be
directed to the other positions by overcoming the bias. Alternatively, the
handle 60 may include one
or more features, e.g., pockets, notches, and the like (not shown), providing
tactile feedback and/or
for releasably securing the inner member 30 in one of the positions. In
addition or alternatively, the
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handle 60 may include one or more visual markers (not shown), e.g., to inform
the user when the
various positions are achieved. In a further alternative, the first sealing
member 38a may be
eliminated and the first position eliminated, e.g., if there is less concern
with profile of the apparatus
during introduction and/or to simplify operation of the apparatus 10.
With continued reference to FIG. 1, the handle 60 may also include one or more
ports for
coupling one or more fluid sources to the apparatus 10, such as a source of
inflation media, a source of
vacuum, and/or a source of diagnostic and/or therapeutic agents (not shown).
For example, as shown,
a side port 64 may communicate with the first lumen 26. The side port 64 may
include one or more
connectors (not shown) to facilitate coupling one or more sources of fluid to
the side port 64, e.g., a
Luer lock connector, and/or one or more seals, e.g., a hemostatic seal, to
prevent fluid from leaking
from the side port 64.
A syringe or other source of fluid (not shown) may be coupled to the side port
64 to allow
delivery of the fluid through the first lumen 26 into the interior 56 of the
balloon 50 and/or through the
outlet 58, depending upon the position of the inner member. For example, if
the inner member 30 is in
the second (infusion) position, contrast material, e.g., radiopaque,
echogenic, or other fluid that
facilitates observation using fluoroscopy, ultrasound, or other external
imaging, may be delivered
through the first lumen 26 and outlet 58 into a body lumen. Such material may
facilitate monitoring
the apparatus 10 during advancement through a patient's body into a target
body lumen and/or to
identify the status of treatment of a body lumen, as described further below.
With the inner member 30
in the third position, the same fluid may be delivered through the first lumen
26 to expand the balloon
50, or the source of contrast material may be replaced with a source of a
different fluid, e.g., a syringe
of saline, to facilitate expansion and/or collapse of the balloon 50.
Alternatively, multiple ports may be provided that communicate with the first
lumen 26, e.g.,
such that various fluids may be delivered selectively through the first lumen
26 depending upon the
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desired function. For example, a source of contrast and a source of saline
could be coupled to
different ports such that each fluid may be delivered independently depending
upon the position of
the inner member 30 without having to change out the sources. Alternatively, a
source of one or
more therapeutic agents may be coupled to the side port 64 (or to a separate
port), e.g., when
desired, to deliver the agent(s) into the target body lumen.
Optionally, the handle 60 may include one or more seals, bushings, and the
like to facilitate
relative motion of the outer and inner members 20, 30 and/or to seal the first
lumen 26. For example,
as shown in FIG. 1, an o-ring 66 may be provided between the outer and inner
members 20, 30,
which may guide the inner member 30 as it moves axially relative to the outer
member 30 and
handle 60. The o-ring 66 may also be located proximal to the side port 64,
thereby providing a
substantially fluid-tight seal between the outer and inner members 20, 30 to
prevent leakage of fluid
introduced into the side port 64 from the handle 60.
As shown, the pull handle 162 includes a port 163 for receiving a guidewire or
other rail
(not shown) therethrough. For example, a guidewire may be introduced into the
second lumen 136,
e.g., from the port 163 or by backloading into the inner member distal end
134. The port 163 may
include one or more seals, e.g., a hemostatic seal (not shown), to accommodate
passage of a
guidewire through without risk of substantial risk of leakage of blood or
other body fluids from the
second lumen 136.
Optionally, the outer member 20 may include one or more additional lumens (not
shown)
extending between the proximal and distal ends 22, 24, e.g., a guidewire lumen
for receiving a
guidewire or other rail (not shown), e.g., if the inner member 30 does not
include the second lumen
36, an inflation lumen for delivering inflation media to another balloon (not
shown) on the distal
end 24, and the like.
In addition or alternatively, if desired, the apparatus 10 may include one or
more markers to
facilitate positioning and/or advancement of the apparatus 10 during use. For
example, one or more
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radiopaque markers may be placed on the outer member distal end 24, on the
inner member 30 within
or adjacent the balloon 50 or distal tip 35, on the balloon 50, e.g., on the
proximal and/or distal ends
52, 54, and/or on the sealing member(s) 38. Alternatively, one or more
components of the apparatus
may be formed from radiopaque or other materials that may facilitate imaging
the apparatus 10
during use. For example, radiopaque markers and/or materials may facilitate
positioning or otherwise
imaging the apparatus 10 using fluoroscopy or other x-ray imaging, e.g., when
positioning the balloon
50 (either before or after expansion) and/or when infusing fluid via the
outlet 48. Alternatively,
echogenie markers and/or materials may be provided to facilitate imaging using
ultrasound or similar
imaging techniques.
With continued reference to FIGS. 2-5, an exemplary method will now be
described for
treating a body lumen (not shown), e.g., using an apparatus 10, which may be
any of the
embodiments described herein, and not necessarily limited to the embodiment
shown and described
below with reference to FIG. 1. The target body lumen may be a blood vessel,
e.g., a vein or artery,
a graft, e.g., an aorto-venous fistula, tubular xenograft, or synthetic
tubular graft, and the like. For
example, the body lumen may be a passage communicating between an adjacent
artery and vein
(not shown), e.g., in an arm or other region of a dialysis patient.
Alternatively, the body lumen may
be a blood vessel within a patient's vasculature, e.g., a peripheral vessel in
a patient's leg, a cerebral
vessel, and the like. In a further alternative, the material may be a stone
within a patient's urinary
tract or other foreign object to be removed from the patient's body.
Optionally, the body lumen may be accessed using one or more additional
instruments (not
shown), which may be part of a system or kit including the apparatus 10. For
example, an introducer
sheath, guide catheter, or other tubular member (not shown) may be introduced
adjacent the target
site where the material is to be removed, or may be introduced elsewhere in
the patient's body to
provide access to the patient's vasculature or other passages communicating
with the body lumen. If
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the body lumen is located in a peripheral vessel of the patient, a
percutaneous puncture or cut-down
may be created using a needle or other instrument (not shown) at a peripheral
location, such as a
femoral artery, carotid artery, or other entry site (also not shown), and an
introducer sheath may be
placed through the puncture at the peripheral location to provide access. The
apparatus 10 may be
advanced through the patient's vasculature from the entry site, e.g., alone or
with the aid of a guide
catheter, guidewire, and the like (not shown).
For example, to facilitate directing the apparatus 10 from an entry site to
the target body
lumen, a guide catheter, micro-catheter, or other tubular body may be placed
from the entry site to the
body lumen using conventional methods. In addition or alternatively, a
guidewire (not shown) may
be placed from the entry site to the body lumen if desired, e.g., if the inner
member 30 includes the
second lumen 36. The tubular body may also be used for aspiration, e.g.,
coupled to a source of
vacuum for capturing material removed by the apparatus 10.
Initially, with reference to FIG. 2, the apparatus 10 may be advanced into the
body lumen
with the inner member 30 in the second or distal position, e.g., such that the
balloon 50 is stretched to
reduce its profile. Optionally, if the first sealing member 38a does not seal
the outlet 58, one or more
fluids may be delivered into the body lumen, e.g., to facilitate imaging
and/or positioning the
apparatus 10. Alternatively, the inner member 30 may be directed to the first
position, shown in FIG.
3, and fluid delivered to facilitate imaging.
For example, radiopaque contrast or other fluid may be delivered into the body
lumen via the
annular passage defined by the first lumen 26 between the outer and inner
members 20, 30 to facilitate
locating and/or measuring the size of the material 92 using fluoroscopy.
Markers (not shown) on the
apparatus 10 may facilitate positioning the balloon 50 relative to material
intended to be removed
before the balloon 50 is expanded, e.g., to facilitate verifying that the
balloon 50 is positioned distal to
or otherwise beyond the material. If desired, the inner member 30 may be
directed back and forth
between the first and second positions, e.g., to allow infusion of contrast
and to reduce the profile of
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the apparatus 10 to facilitate further advancement, e.g., until the balloon 50
is located beyond
obstructive material targeted for removal.
Optionally, the apparatus 10 may be introduced through a guide catheter or
other tubular
member (not shown), that includes a lumen communicating with a source of
vacuum. With the
balloon 50 disposed beyond the guide catheter but not yet expanded, the source
of vacuum may be
activated to aspirate material within the body lumen during the subsequent
treatment.
Turning to FIG. 4, the inner member 30 may be directed to the third position,
thereby
sealing the outlet 58, and the balloon 50 may be inflated within the body
lumen, e.g., such that the
balloon 50 extends substantially entirely across the body lumen. The entire
apparatus 10 may then
be retracted to pull the occlusive material from the body lumen, e.g., to be
aspirated into guide
catheter, or otherwise removed from the body lumen. As shown in FIG. 5, if
desired, the inner
member 30 may be pulled to further expand the balloon 50, e.g., to
substantially engage the wall of
the body lumen. The additional pressure from the balloon 50 may facilitate
separating adherent
material from the wall of the body lumen and allow its removal.
Once material is removed, the inner member 30 may be directed back towards the
second
position, and fluid introduced to observe the amount of material removed
and/or remaining within the
body lumen. If additional material is to be removed, the inner member back be
directed to the first
position, e.g., if desired to advance the apparatus 10 through additional
material to be removed. Once
the balloon 50 is located beyond the material, the process may be repeated as
often as desired.
If desired, the obstructive material may be treated, e.g., at least partially
dissolved,
macerated, and the like before, during, or after withdrawal. For example, a
therapeutic agent may be
delivered into the body lumen via the first lumen 26 of the outer member 20,
e.g., to at least partially
dissolve or separate thrombus or other relatively soft material before being
removed by the balloon
50 and/or otherwise to treat the wall of the body lumen.
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Because a single lumen, i.e., the first lumen 26, is used for both inflation
of the balloon 50
and delivering fluid into the body lumen, the profile of the outer member 20
and therefore of the
overall apparatus 10 may be smaller than devices that include separate
inflation and infusion lumens.
Further, although the second lumen 36 of the inner member 30 could be used for
infusion of fluids,
this would generally require removing the guidewire over which the apparatus
10 is introduced since
the guidewire may substantially fill the second lumen 36. Because the first
lumen 26 may be used for
infusion, the guidewire may remain within the second lumen 36 throughout the
procedure, thereby
potentially reducing the number of guidewire or other device exchanges.
Further, the apparatus 10
may remain over the guidewire, which may facilitate advancing the apparatus 10
to other target body
lumens intended for treatment.
In various alternatives, the valve created by the sealing member(s) 38 and the
outlet 58 of the
balloon 50 may be provided at other locations on the apparatus 10, if desired.
For example, the
configuration may be reversed such that the outlet 58 and sealing members 38
may be located
proximal to the balloon 50. For example, a sealing member (not shown) may be
provided on the
distal end 24 of the outer member 20, and the proximal end 52 of the balloon
50 may float adjacent
the sealing member(s), with the distal end 54 of the balloon 50 is secured to
the distal end 34 of the
inner member 30 (also not shown). Thus, movement of the inner member 30
relative to the outer
member 20 may cause the balloon proximal end to selectively engage or
disengage the sealing
member(s), allowing infusion from the first lumen 24 when the balloon proximal
end is not engaged
with the sealing member(s) and allowing balloon inflation when the balloon
proximal end engages
the sealing member(s).
In another alternative, a balloon (not shown) may be provided on the distal
end 24 of the
outer member 20 proximal to the balloon 50 and/or on the distal end 34 of the
inner member 30
distal to the balloon 50, if desired, similar to other embodiments described
herein. Such a balloon
may be a non-compliant, high pressure balloon, e.g., for dilating the body
lumen, or an elastic,
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compliant balloon for substantially sealing the body lumen to isolate one or
more regions of the body
lumen before infusion of fluid therein.
Turning to FIG. 7, another embodiment of an apparatus 110 is shown for
treating a body
lumen that generally includes an outer tubular member 120, an inner member
130, and an
expandable balloon 150 carried by the inner and/or outer members 120, 130,
similar to the previous
embodiments. The apparatus 110 may be operable in a first mode for infusing
fluid into a body
lumen, a second mode for dilating an obstruction within a body lumen, and/or a
third mode for
removing obstructive material within a body lumen, as described further below.
As shown, the outer member 120 includes a proximal end 122, a distal end 124
sized for
introduction into a body lumen, and a first lumen 126 extending therebetween,
which may be
constructed similar to the previous embodiments. The inner member 130 also
includes a proximal
end 132, a distal end 134, and, optionally, a second lumen 136 extending
between the proximal and
distal ends 132, 134, e.g., sized to slidably receive a guide wire, or other
rail (not shown)
therethrough. The inner member 130 is sized to be slidably received within the
first lumen 126 of
the outer member 120, e.g., such that an annular space is defined between the
outer and inner
members 120, 130 for passing one or more fluids therethrough, also similar to
the previous
embodiments.
The balloon 150 includes a proximal end 152 coupled to the outer member distal
end 124, a
distal end 154 defining an outlet 158, and an interior 156 communicating with
the first lumen 126 and
the outlet 158. The distal end 134 of the inner member 130 may extend through
the distal end 154 of
the balloon 150, e.g., such that the outlet 158 defines an annular passage
between the distal end 154 of
the balloon 150 and the distal end 134 of the inner member 130. As shown, the
distal end 154 of the
balloon 150 includes a collar or sleeve 155 attached or otherwise secured to
the distal end 154, e.g.,
by bonding with adhesive, interference fit, sonic welding, fusing, and the
like. Optionally, the collar
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155 may extend proximally into the interior 156 of the balloon 150 (not shown)
and the interior
section of the collar 155 may include one or more side ports or other openings
(also not shown), e.g.,
to facilitate fluid passing from the balloon interior 156 through the outlet
158.
The balloon 150 may be formed from substantially inelastic material, e.g., to
provide a non-
compliant balloon that expands to a predetermined size when inflated
independent of pressure (once
a minimum volume is introduced to achieve the predetermined size). Such a non-
compliant balloon
150 may expand to the predetermined size even if inflated to relatively high
pressures, e.g., until the
balloon 150 bursts or otherwise ruptures, e.g., at pressures at ten
atmospheres, twenty atmospheres,
thirty atmospheres, and the like. Alternatively, the balloon 150 may be formed
from elastic material,
similar to other embodiments described elsewhere herein.
One or more sealing members 138 may be carried on the inner member distal end
134, e.g.,
such that the sealing member(s) 138 are movable relative to the balloon 150 as
the inner member 130
is moved, e.g., to provide a valve for selectively opening and closing the
outlet 158 of the balloon
150. As shown, a first sealing member 138 is provided on the inner member 130
distal to the balloon
distal end 154 and collar 155. The sealing member 138 may have a size, e.g.,
outer diameter, that is
larger than the collar 155 and distal end 154 of the balloon 150 such that the
sealing member 138 may
substantially engage the collar 155 and/or distal end 154 of the balloon 150
to substantially seal the
outlet 158.
In the exemplary embodiment shown, the sealing member 138 may include a
tapered shape,
e.g., on one or both of its proximal and distal ends. For example, a tapered
shape on the proximal
end of the sealing member 138 may automatically guide the sealing member 138
into being seated in
the outlet 158 of the balloon 150, e.g., to enhance a fluid-tight seal
therebetween. A tapered shape
on the distal end of the sealing member 138 may provide a rounded or otherwise
substantially
atraumatic tip for the apparatus 110. Alternatively, a substantially
atraumatic distal tip (not shown)
may be provided on the inner member 130 beyond the first sealing member 138,
similar to the
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previous embodiments.
With continued reference to FIG. 7, a handle or hub 160 may be coupled to or
otherwise
provided on the proximal end 122 of the outer member 120, e.g., for
manipulating the outer member
120 and/or the entire apparatus 110, generally similar to the previous
embodiments. The handle 160
may include a pull handle 162 or other actuator coupled to the inner member
130 for moving the
inner member 130 to the various positions described below. The handle 160 may
also include one or
more ports, such as side port 164 for coupling one or more fluid sources to
the apparatus 110, e.g., a
syringe or other source of fluid for delivering fluid through the first lumen
126 into the interior 156 of
the balloon 150 and/or through the outlet 158, depending upon the position of
the inner member 130.
Optionally, the handle 160 may include one or more seals, bushings, and the
like, such as a-
ring 166, between the outer and inner members 120, 130, which may guide the
inner member 130 as it
moves axially relative to the outer member 130 and handle 160. In this
embodiment, the inner
member 130 includes a section of hypotube or other substantially rigid tubing
131 attached or
otherwise coupled to the proximal end 132 of the inner member 130. The tubing
131 may provide
axial support for the inner member 130, e.g., to prevent buckling or kinking
when the inner member
130 is directed axially. The tubing 131 may also allow the inner member 130 to
move axially more
easily, e.g., if the tubing 131 has a substantially smooth or lubricated outer
surface that slides easily
through the o-ring 166 while maintaining a fluid-tight seal therebetween.
In addition or alternatively, if desired, the apparatus 110 may include one or
more markers
to facilitate positioning and/or advancement of the apparatus 110 during use.
For example, as
shown in FIG. 7, radiopaque marker bands 137 may be attached around the distal
end 134 of the
inner member 130, e.g., within the balloon interior 56. As shown, a marker 137
is attached
adjacent both the proximal end 152 and the distal end 154 of the balloon 150,
which may facilitate
monitoring the location of the balloon 150 before dilating an obstruction
within a body lumen. In
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addition or alternatively, a core wire of the helical member 170 may be formed
from radiopaque
material, and/or radiopaque filler material, BAS04, may be dispersed into
plastic material used to
form the helical member 170, if desired.
Unlike the previous embodiments, the apparatus 110 includes a helical member
170
coupled between the outer and inner members 120, 130 within the balloon
interior 156. The
helical member 170 may be movable from a relatively low profile, such as that
shown in FIG. 7,
to an expanded helical shape, as described further below. As shown, the
helical member 170 is a
wire, tube, or other filament including a first end 172 coupled to the distal
end 124 of the outer
member 120 and a second end 174 coupled to the distal end 134 of the inner
member 130. For
example, the helical member 170 may be from a core wire having a tube or
sleeve formed or
attached around the wire (not shown). Between the first and second ends 172,
174, the helical
member 170 may wrap helically around the inner member 130 one or more times.
As shown, the
helical member 170 extends around the inner member 130 about one and a half
turns, although it
will be appreciated that the helical member 170 may include more or fewer
turns.
As shown, the first end 172 of the helical member 170 may be attached or
otherwise secured
directly to the distal end 124 of the outer member 120, e.g., by one or more
of bonding with adhesive,
sonic welding, soldering, interference fit (e.g., by wrapping the first end
172 one or more times around
the distal end 124), inserting the first end 172 into an annular groove, hole,
or pocket (not shown) in the
distal end 124, fusing, and the like. The second end 174 of the helical member
170 may be similarly
attached or otherwise secured to a sleeve 178 fixed to the distal end 134 of
the inner member 130 or
directly to the distal end 134.
The sleeve 178 may be a relatively short tube attached to the inner member
distal end 134
adjacent the balloon distal end 154, e.g., by bonding with adhesive, sonic
welding, interference fit,
fusing, and the like. The sleeve 178 may have an outer diameter larger than
the inner diameter of the
collar 155 and/or distal end 154 of the balloon 150, thereby providing a stop
that limits movement of
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the collar 155 and distal end 154 relative to the inner member 130. When the
sleeve 178 contacts the
collar 155 and/or distal end 154, the sleeve 178 may not substantially
obstruct the annular passage
communicating with the outlet 158, e.g., such that fluid may still flow
through the outlet 158 when
introduced into the balloon interior 156. Alternatively, the sleeve 178 may be
shaped to substantially
seal the outlet 158 when the sleeve 178 engages the collar 155 and/or distal
end 154 of the balloon
150, similar to the other sealing members described elsewhere herein.
Optionally, during
manufacturing or assembly, the collar 155 may be positioned between the
sealing member 138 and the
sleeve 178 when the collar and sleeve 178 are attached to the inner member
distal end 134, i.e., before
attaching the collar 155 to the balloon distal end 154. The balloon distal end
154 may then be attached
over the collar 155 when the balloon 154 is attached to the outer member
distal end 124. If desired,
the balloon distal end 154 may be attached to the collar 155 such that a
proximal section of the collar
155 is disposed within the interior 156 of the balloon 150. If so, the
proximal section of the collar 155
may include one or more openings (not shown) to facilitate fluid passing from
the balloon interior 156
through the collar 155 and out the outlet 158, i.e., when the outlet 158 is
not sealed by the sealing
member 138, as described further below.
The inner member 130 may be movable axially relative to the outer member 120,
e.g.,
between a first or distal position, a second or intermediate position (shown
in FIG. 7), and/or a third
or proximal position (not shown), thereby allowing the apparatus 110 to
provide different functions
for treating a body lumen. For example, in the first position, the inner
member 130 may direct the
sealing member 138 distally such that the sealing member 138 is spaced apart
from the balloon
outlet 158. Thus, fluid introduced through the first lumen 126 of the outer
member 120 may pass
through the balloon interior 156 and out the outlet 158, e.g., into the body
lumen beyond the distal
tip 35, similar to the previous embodiments.
If desired, the inner member 130 may be directed proximally to a second
position, such as
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that shown in FIG. 7, in which the sealing member 138 engages the collar 155
and/or distal end
154 of the balloon 150, thereby substantially sealing the outlet 158 from
fluid flow therethrough.
Thus, any fluid introduced through the first lumen 126 enters the balloon
interior 156 and may
expand the balloon 150. In this mode, the balloon 150 may be expanded to an
elongate
substantially cylindrical shape, e.g., having a substantially uniform diameter
main portion between
tapered end portions. In the expanded condition, the main portion of the
balloon 150 may have a
length between about twenty and eighty millimeters (20-80 mm) and a diameter
between about
three and twelve millimeters (3-12 mm). The balloon 150 may be used to dilate
or otherwise apply
substantial pressure to a wall of a body lumen, e.g., for dilating a stenosis,
lesion, or other
obstruction, similar to the method shown in FIGS. 9E-9G and described further
below.
In addition or alternatively, after inflating the balloon 150 to dilate the
body lumen, a source
of vacuum may be coupled to the side port 164 and the balloon 150 collapsed to
a contracted
condition around the helical member 170. Alternatively, if the balloon 150 has
not been previously
inflated, it may not be necessary to collapse the balloon 150 using vacuum
since the balloon 150 may
already be sufficiently collapsed or otherwise remain in the contracted
condition.
The inner member 130 may then be directed proximally to the third position,
thereby
directing the ends of the helical member 170 towards one another. This causes
the helical
member 170 to expand radially outwardly as it is compressed axially, thereby
causing the balloon
150 also to compress axially and expand radially into an expanded helical
shape around the
helical member 170, e.g., as shown in FIG. 7A. Optionally, the inner member
130 and/or handle
150 may include one or more stops (not shown) that limit proximal movement of
the inner
member 130 when compressing and expanding the balloon 150 and helical member
170. For
example, the stop(s) may allow the inner member 130 to be pulled until the
balloon length is
reduced to between about six and thirty millimeters (6-30 mm), thereby
preventing
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CA 2913525 2017-08-02
overcompression of the balloon 150 and/or helical member 170.
In one embodiment, the helical member 170 may have sufficient rigidity that
the helical
member 170 may simply buckle elastically from the low profile towards the
helical shape as it is
compressed axially. Thus, the helical member 170 may expand without
substantial plastic
deformation such that the helical member 170 may be returned to its original
low profile shape (and
expanded and collapsed repeatedly, if desired). Alternatively, the helical
member 170 may be biased
to a predetermined expanded helical shape but may be constrained in the low
profile, e.g., by
providing axial tension on the ends 172, 174 of the helical member 170 when
the inner member 130
is in the first or second positions. As the inner member 130 is directed
towards the third position,
the tension may be released, whereupon the helical member 170 may resiliently
expand towards the
expanded helical shape.
In another alternative, the helical member may be integrally formed or
otherwise coupled
directly to the balloon 150, e.g., attached to, embedded within, or otherwise
secured to the balloon
wall (not shown) between the proximal and distal ends 152, 154. For example,
as shown in FIG. 7B
and 7D, one or more helically shaped wires or fibers 157' (e.g., one shown in
FIG. 7B, two shown in
FIG. 7D) may be molded, embedded, or integrally formed in the wall of the
balloon 150.' As the
balloon 150' is compressed axially when the inner member 130 is moved towards
the third position,
the fiber(s) 157' may automatically bias the balloon 150' towards the expanded
helical shape.
Alternatively, as shown in FIG. 7C, a fiber 157" may be molded, embedded, or
integrally formed in
the wall of the balloon 150" that includes a core wire or member 159," e.g., a
radiopaque material, a
biased core wire, and the like. In further alternatives, FIGS. 7E-7H show
alternate shapes and/or
configurations for a fiber 157. to 157h or other stiffening features that may
be molded, embedded, or
otherwise integrally formed in the wall of the balloon 150e to 150h and extend
helically between
proximal and distal ends of the balloon 150, to 150h. The fiber(s) and/or
stiffening features may
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CA 2913525 2017-08-02
include one or more turns between the proximal and distal ends of the balloon
150', 150", or 150, to
15011, e.g., one and a half, two, three, four, or more turns. In addition, any
of the fibers and/or
stiffening features included on a balloon may provide cutting edges or
elements, e.g., that may be at
least partially embedded into a wall of a body lumen when the balloon 150',
150", or 150,to 150h is
inflated to dilate an obstruction in a body lumen.
Returning to FIG. 7, with the balloon 150 in the expanded helical shape, the
entire apparatus
110 may be directed along a body lumen, e.g., to remove obstructive material
including scraping,
scrubbing, or otherwise separating adherent material from a wall of the body
lumen, if desired, similar
to the method shown in FIGS. 9A-9D and described further below. Thus, in this
embodiment, a single
balloon 150 may be used for both dilation, e.g., using relatively high
pressures, and for scraping,
scrubbing, or otherwise removing obstructive material within a body lumen.
Turning to FIGS. 23A and 23B, an apparatus 110' is shown that is generally
similar to the
apparatus 110 of FIG. 7, except that the apparatus 110' includes an
alternative embodiment of a handle
760 on the proximal end 122' of the outer member 120'. Generally, the handle
760 includes an outer
housing 761 (shown in FIG. 23A), an inner carriage 765 (shown in FIG. 23B)
slidable axially within
the housing 761, a rotary knob 762 carried by the housing 761 and coupled to
the carriage 765, and a
hub 763 extending from the housing 761.
The housing 761 may include one or more pieces, e.g., one or more sets of
mating halves or
clamshells (not shown) that may be connected together, e.g., along a
longitudinal seam (also not
shown) to provide the housing 761, e.g., secured together by mating
connectors, bonding with
adhesive, sonic welding, fusing, and the like. The housing 761 may include a
slot, track or other
features (not shown) that allow the carriage 765 to slide axially within the
housing 761without
substantial lateral movement. The housing 761 and/or carriage 765 may include
one or more
cooperating features, e.g., stops (not shown) within the housing 761 that
limit axial movement of the
carriage 765 relative to the housing 761, for example, to limit movement of
the inner member 130'
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CA 2913525 2017-08-02
between the first position (for infusion from the outlet 158) and the third
position (where the balloon
150' is directed to an expanded helical shape, not shown).
The housing 761 may include a side port 764, e.g., including a Luer lock or
other connector,
for connecting a source of fluid to the apparatus 110.' The side port 764 may
communicate with a
lumen extending through the outer member 120' for delivering fluid into the
interior of the balloon
150; similar to the previous embodiments.
The knob 762 may include an outer portion 762a surrounding or otherwise
extending radially
from the housing 761, e.g., including ridges or other features to facilitate
rotation or other manipulation
of the knob 762 during use, and an inner stem 762b that extends axially along
a first passage 765a
within the carriage 765. The inner stem 762b and the carriage 765 may include
cooperating features,
e.g., helical threads 762c, that translate rotation of the knob 762 into axial
movement of the carriage
765. Thus, the knob 762 may be substantially fixed axially relative to the
housing 761 and freely
rotatable about a longitudinal axis of the apparatus 110.'
The proximal end 132' of the inner member 130' may pass freely through the
inner stem
762b and be fixed relative to the carriage 765. For example, the inner member
proximal end 132'
may be secured to the carriage 765 by fixing the proximal end 132' in a second
passage 765b
adjacent to and/or communicating with the first passage 765a, e.g., bonding
with adhesive, sonic
welding, fusing, interference fit, mating connectors (not shown), and the
like. Thus, axial
movement of the inner member 130' may be coupled to movement of the carriage
765.
The hub 763 may include a hypotube or other tubular member 763a and a Luer
lock or other
connector 763b secured to one another and/or to the outer housing 761. For
example, a proximal
end of the tubular member 763a and/or the connector 763b may be attached to a
proximal end of the
housing 761, e.g., by bonding with adhesive, sonic welding, fusing,
interference fit, mating
connectors (not shown), and the like.
The tubular member 763a may be slidably received in the second passage 765b
such that the
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tubular member 763a and connector 763b remain substantially stationary
relative to the housing 761
as the carriage 765 is directed axially. One or more seals, e.g., o-ring 766,
may be provided within
or around the second passage 765b that allow the tubular member 763a to slide
therethrough while
providing a fluid-tight seal that prevents fluid from leaking through the
passages 765a, 765b and out
of the housing 761.
During use, the knob 762 may be rotated in a first direction, thereby
translating the inner
member 130' distally to the first position to open the outlet 158.' Thus,
fluid delivered through the
outer member 120' may pass through the balloon 150' and exit the outlet 158,'
as described above.
The knob 762 may be rotated in a second opposite direction, thereby
translating the inner member
130' proximally to the second position, e.g., until the sealing member 138'
seals the outlet 158' to
allow balloon expansion, and/or further to the third position, e.g., to expand
the balloon 150' to the
expanded helical shape, also as described above. Optionally, the knob 762
and/or housing 761 may
include visual, audible, or other indicators (not shown) that identify the
direction to rotate the knob
762 to achieve the desired position(s) and/or that indicate when a particular
position is achieved,
e.g., by aligning an arrow (not shown) on the knob 762 with respective
indicators (also not shown)
that identify the first, second, and/or third positions. Otherwise, the
apparatus 110' may operate
similar to the previous embodiments.
Turning to FIGS. 24A-24C, another embodiment of a handle 860 is shown that
includes an
outer housing 861 with a side port 864 (shown in FIG. 24A), an inner carriage
865 (shown in FIG.
24B) slidable axially within the housing 861, and a hub 863 extending from the
housing 861,
generally similar to the handle 760. For example, the housing 861 may include
one or more pieces,
e.g., one or more sets of mating halves or clamshells (not shown) that may be
connected together
and may include a slot, track or other features (not shown) that allows the
carriage 865 to slide
axially within the housing 861, e.g., without substantial lateral movement.
The housing 861 and/or
carriage 865 may include one or more features that limit axial movement of the
carriage 865
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relative to the housing 861, e.g., to limit movement of the inner member 130'
between the first
position (for infusion from the outlet 158'), second position (for balloon
inflation), and the third
position (where the balloon 150' is directed to an expanded helical shape, not
shown).
The proximal end 132' of the inner member 130' is substantially fixed relative
to the
carriage 865, e.g., by fixing the proximal end 132 in a passage 865a adjacent
to a distal end of the
carriage 865, for example, bonding with adhesive, sonic welding, fusing,
interference fit, mating
connectors (not shown), and the like. Thus, axial movement of the inner member
130' may be
coupled to movement of the carriage 865.
The hub 863 may include a hypotube or other tubular member 863a and a Luer
lock or
other connector 863b secured to one another and/or to the outer housing 861.
For example, a
proximal end of the tubular member 863a and/or the connector 863b may be
attached to a proximal
end of the housing 861, e.g., by bonding with adhesive, sonic welding, fusing,
interference fit,
mating connectors (not shown), and the like.
The tubular member 863a may be slidably received in the passage 865a, e.g.,
adjacent a
proximal end of the carriage 865, such that the tubular member 863a and
connector 863b remain
stationary relative to the housing 861 (and inner member proximal end 132') as
the carriage 865 is
directed axially. With both the tubular member 863a and inner member proximal
end 1323' received
in the passage 865a, a guidewire or other instrument, backloaded through the
inner member 130' may
pass freely through the passage 865a, tubular member 863a, and out the
connector 863b (or inserted
through the connector 863b into the inner member 130'). One or more seals,
e.g., o-ring 866, may be
provided within or around the passage 865a that allow the tubular member 863
to slide therethrough
while providing a fluid-tight seal that prevents fluid from leaking through
the passage 865a out of the
housing 861.
Instead of a rotary knob 762, the handle 860 includes a push button 862
carried by the
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housing 861 and coupled to the carriage 865. For example, the housing 861 may
include an
elongate slot 861a and the push button 862 may be slidable axially within the
slot 861a.
Optionally, as shown, the slot 861a may include one or more pockets or detents
861b that may
capture the push button 862, e.g., to releasably secure the push button 862,
and consequently the
carriage 865 and inner member 130,' in one or more positions.
Optionally, the housing 861 may include one or more visual indicators, e.g.,
for identifying
the position of the inner member 132' when the push button 862 is received in
a particular pocket
861 b. For example, as shown in FIG. 24C, the housing 861 may include numbers
or other symbols
861c aligned with respective pockets (not shown) such that when the push
button, in this
embodiment. lever 862 is aligned with a particular symbol 861c, the user can
confirm that the inner
member 130' is in a respective particular position.
As best seen in FIG. 24B, the push button 862 may include a base 862a
substantially fixed
relative to the carriage 865 and a cap 862b slidable laterally relative to the
base 862a. For example,
the base 862a may be integrally molded or otherwise formed with the carriage
865 and the cap 862b
may be attached to the base 862a such that the cap 862b may be slid laterally,
e.g., substantially
perpendicular to the longitudinal axis of the handle 860. For example, the cap
862b may be biased
such that the cap 862b may automatically slide into a pocket 861b with which
the cap 862b is aligned,
yet the bias may be overcome to move the cap 862b out of the respective pocket
861b into the slot
861a so that the cap 862b maybe slid axially into another pocket 861b. For
example, a spring or other
biasing mechanism (not shown) may be provided within the cap 862b or housing
861 that may push
the cap 862b laterally from the base 862a.
Alternatively, the entire push button 862 may be fixed relative to the
carriage 865, e.g.,
integrally molded or formed together, and the push button 862 and carriage 865
may be pivoted about
the longitudinal axis to allow the cap 862b to be directed out of a particular
pocket 861b, directed
axially along the slot 861a, and released or otherwise placed in another
pocket 861 b. In this
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alternative, a spring or other biasing mechanism (not shown) may bias the push
button 862 and
carriage 865 to direct the cap 862b into any pocket 861b with which the cap
862b is aligned when the
cap 862b is released.
In an exemplary embodiment, the handle 860 may include three pockets 861b,
e.g., one
corresponding to the first position of the inner member 130,' one
corresponding to the second
position, and one corresponding to the third position. Thus, to place the
inner member 130' in any
of the first, second, or third positions, the cap 862b may be directed out of
a pocket within which
the cap 862b is received, the push button 862 may be slid axially along the
slot 861a, and released
or otherwise directed into the desired pocket 861b. Alternatively, the handle
860 may include only
one or two pockets 861b, e.g., if the push button 862 is biased axially to one
of the positions.
During use, the push button 862 may be directed axially in a first direction,
e.g., distally to
the indicator "R" in FIG. 24C, and released or captured in a corresponding
pocket, thereby
translating the inner member 130' distally to the first position to open the
outlet 158.' Thus, fluid
delivered through the outer member 120' may pass through the balloon 150' and
exit the outlet 158,'
as described above. The push button 862 may be directed out of the pocket and
directed axially,
e.g., proximally, to the indicator "N", thereby translating the inner member
130' proximally to the
second position, e.g., until the sealing member 138' seals the outlet 158' to
allow balloon expansion.
In addition, if desired, the push member 872 may be directed out of the "N"
pocket, axially within
the slot 861a, and released in the third pocket, corresponding to indicator
"D," thereby translating
the inner member 130' to the third position, e.g., to expand the balloon 150'
to the expanded helical
shape, also as described above.
Turning to FIGS. 25A and 25B, still another embodiment of a handle 960 is
shown that
includes an outer housing 961 including a side port 964 (shown in FIG. 25A), a
carriage (not shown)
within the housing 961, and a hub 963 extending from the housing 961,
generally similar to the
previous embodiments. The carriage may include a rack 965 (shown in FIG. 25B)
including a
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CA 2913525 2017-08-02
plurality of teeth 965a spaced apart axially along the rack 965.
The proximal end (not shown) of the inner member 130' may be substantially
fixed
relative to the carriage (not shown) such that axial movement of the inner
member 130' is
coupled to movement of the carriage and consequently to the rack 965, similar
to the previous
embodiments.
The hub 963 may include a hypotube or other tubular member (not shown) and a
Luer lock
or other connector 963b secured to one another and/or to the outer housing
961, similar to the
previous embodiments. The tubular member may be slidably received in a passage
in the carriage,
e.g., such that the connector 963b remains substantially stationary relative
to the housing 961 (and
inner member 130') as the carriage is directed axially.
In this embodiment, the actuator is a rotary wheel 962 rotatably mounted to
the housing 961,
as shown in FIG. 25A. The rotary wheel 962 includes an outer wheel 962a
including ridges or
other features to facilitate engaging and/or rotating the rotary wheel 962,
and a pinion 962b that
extends into the housing 961. As best seen in FIG. 25B, teeth on the pinion
962b may interlock with
the teeth 965a on the rack 965 such that rotation of the outer wheel 962a
causes the rack 965, and
consequently, the inner member 130,' to move axially relative to the housing
961 and outer member
120.' Optionally, the housing 961 may include one or more visual indicators,
e.g., for identifying
the position of the inner member 132' when the wheel 962a is rotated to one or
more orientations,
similar to the previous embodiments.
During use, the rotary wheel 962 may be rotated in a first direction, e.g., to
translate the inner
member 130' distally to the first position to open the outlet 158.' When
desired, the rotary wheel
962 may be rotated in a second opposite direction to translate the inner
member 130' proximally to
the second position and/or third position, e.g., to allow inflation of the
balloon 150' and/or expanding
the balloon 150' to the expanded helical shape, similar to the previous
embodiments. One advantage
of the rotary wheel 962 is that the ratio of the outer wheel 962a, pinion
962b, and teeth 965 on the
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CA 2913525 2017-08-02
rack 965 may be designed to provide a desired mechanical advantage and/or
precision of movement
of the inner member 130.'
Another embodiment of a handle 1060 is shown in FIGS. 26A and 26B that may be
included
in any of the apparatus shown herein. Similar to the previous embodiments, the
handle 1060 includes
a housing 1061 including a hub 1063 and a side port 1064. In this embodiment,
the actuator is a
squeeze button 1062 that may be depressed to direct the inner member 130'
axially. e.g., from a first
position to a second position, similar to the embodiments described elsewhere
herein. Generally,
when the squeeze button 1062 is pressed inwardly, links I062a, 1062b defining
the button 1062 are
flattened out, thereby directing the proximal link 1062a proximally if the
distal link 1062b is fixed
axially relative to the housing 1061.
For example, a first end of the distal link 1062b may be pivotally coupled to
the housing
1061 and a second end pivotally coupled to a first end of the proximal link
1062. A second end of
the proximal link 1062a may be slidable axially along the housing 861, e.g.,
within a slot or track
(not shown). With the second end of the proximal link 1062a coupled to the
inner member 130,'
e.g., by a cable or other linkage 1062c, as the squeeze button 1062 is pressed
inwardly, the proximal
link 1062 pulls the inner member 130, e.g., from a first position (with the
outlet 158' open) to a
second position (allowing the balloon 158' to be inflated and/or expanded to
the expanded helical
shape).
Optionally a cover (not shown) may be placed over the squeeze button 1062 to
protect the
user from catching anything between the links 1062a, 1062b. In addition or
alternatively, the
squeeze button 1062 may be provided on the top of the housing 1061 (as shown),
e.g., to allow a user
to actuate the squeeze button 1062 with their thumb, or on the bottom of the
housing 1061 (not
shown), e.g., to allow a user to actuate the squeeze button 1062 with their
index finger. Optionally,
the handle 1060 may include one or more features (not shown) to allow the
squeeze button 1062 to be
releasably secured at one or more positions before the links 1062a, 1062b are
completely flattened,
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CA 2913525 2017-08-02
e.g., to allow the inner member 130' to be translated and fixed in different
positions, e.g., successively
in the second and third positions, similar to the previous embodiments.
Turning to FIG. 8, still another embodiment of an apparatus 210 is shown for
treating a body
lumen that generally includes an outer tubular member 220, an inner member
230, and an expandable
balloon 250, and helical member 270 carried by the inner and/or outer members
220, 230, similar to
the previous embodiments, but does not include a valve for opening or closing
an outlet in the
balloon, unlike the embodiment of FIG. 7. The apparatus 110 may be operable in
a first mode for
dilating an obstruction within a body lumen, and/or a second mode for removing
obstructive material
within a body lumen, as described further below.
As shown, the outer member 220 includes proximal and distal ends 222, 224, and
a first
lumen 226 extending therebetween, and the inner member 230 also includes
proximal and distal ends
232, 234, and a second lumen 236 extending therebetween. The inner member 230
is sized to be
slidably received within the first lumen 226 of the outer member 220, e.g.,
such that an annular space
is defined between the outer and inner members 220, 230 for passing one or
more fluids therethrough,
also similar to the previous embodiments.
A handle or hub 260 may be coupled to or otherwise provided on the proximal
end 222 of
the outer member 220, e.g., including a pull handle or other actuator 262 for
moving the inner
member 230 relative to the outer member 220, a side port 264 for coupling one
or more fluid sources
to the apparatus 210, and an o-ring or other seal 166 between the outer and
inner members 220, 230,
which may also be similar to the previous embodiments.
The balloon 250 includes a proximal end 252 coupled to the outer member distal
end 224, a
distal end 254 coupled to the inner member distal end 234, e.g., attached by
bonding with adhesive,
interference fit, sonic welding, fusing, and the like, similar to the previous
embodiments. The
balloon 250 may be formed from substantially inelastic material, e.g., to
provide a non-compliant
balloon that expands to a predetermined size when inflated independent of
pressure, or alternatively,
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the balloon 250 may be formed from elastic material, similar to the other
embodiments described
elsewhere herein.
Also similar to the embodiment of FIG. 7, the helical member 270 is coupled
between the
outer and inner members 220, 230. Thus, the helical member 270 may be movable
from a relatively
low profile, such as that shown in FIG. 8, to an expanded helical shape, as
described further below
with reference to FIGS. 9A-9D. As shown in FIG. 8, a first end 272 of the
helical member 270 may
be attached or otherwise secured directly to the distal end 224 of the outer
member 220 and a second
end 274 of the helical member 270 may be attached or otherwise secured to the
distal end 234 of the
inner member 230 adjacent the balloon distal end 252.
During use, in the exemplary methods shown in FIGS. 9A-9G, the apparatus 210
may be
used for treating a body lumen 90, e.g., for removing obstructive material 92
and/or dilating an
obstruction 94 within a body lumen 90, e.g., as shown in FIG. 9A. Similar to
the previous
embodiments, the target body lumen 90 may be a blood vessel, e.g., a vein or
artery, a graft, e.g., an
aorto-venous fistula, tubular xenograft, or synthetic tubular graft, and the
like.
Optionally, the body lumen may be accessed using one or more additional
instruments (not
shown), which may be part of a system or kit including the apparatus 210,
e.g., including one or
more introducer sheaths, guide catheters, and/or guidewires (not shown). For
example, to facilitate
directing the apparatus 210 from an entry site to the target body lumen, a
guide catheter, micro-
catheter, introducer sheath, or other tubular body (not shown) may be placed
from the entry site to
the body lumen 90 using conventional methods. In addition or alternatively, a
guidewire (not shown)
may be placed from the entry site to the body lumen 90 if desired.
Initially, with reference to FIG. 9B, the apparatus 210 may be advanced into
the body lumen
90 with the inner member 230 in the first or distal position, e.g., such that
the balloon 250 is
substantially collapsed. Optionally, contrast or other fluid may be delivered
into the body lumen 90,
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e.g., via the second lumen 236 in the inner member 230 (not shown, see FIG. 8)
or via a separate
lumen (not shown) in the outer member 220. Markers (not shown) on the
apparatus 10 may
facilitate positioning the balloon 250 relative to the material 92 intended to
be removed, e.g., to
position the balloon 250 beyond or otherwise adjacent the material 92.
Optionally, the apparatus 210 may be introduced through a guide catheter or
other tubular
member (not shown), that includes a lumen communicating with a source of
vacuum. With the
balloon 250 disposed beyond the guide catheter, the source of vacuum may be
activated to aspirate
material within the body lumen 90, e.g., as the materia192 is dislodged or
otherwise removed, by the
balloon 250, as described below.
Turning to FIG. 9C, the inner member 230 may be directed proximally relative
to the outer
member 220, thereby causing the helical member 270 and consequently the
balloon 250 to expand
towards the expanded helical shape, as described above. As shown in FIG. 9D,
the entire apparatus
210 may then be retracted to remove the materia192, e.g., scraping, scrubbing,
or otherwise
separating material that may be adhered to a wall of the body lumen 90. For
example, the apparatus
210 may be pulled to remove the material 92 from the body lumen and into the
lumen of the guide
catheter, where the materia192 may be aspirated from the patient's body.
Alternatively, the material
92 may be released in a manner that the material 92 may be metabolized
naturally by the patient's
body.
If desired, the inner member 230 may be returned to the first position to
collapse the
balloon 250, and the apparatus 210 moved to another location within the body
lumen 90. The inner
member 230 may be directed between the first and second positions as often as
desired to expand
the balloon 250 and separate or otherwise remove sufficient material 92.
Turning to FIG. 9E, with sufficient material 92 removed, a stenosis, lesion,
or other
obstruction 94 is identified within the body lumen 90. The apparatus 210 may
be reintroduced or
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repositioned in the body lumen 90 with the balloon 250 collapsed until the
balloon 250 is positioned
adjacent the obstruction 94, e.g., using fluoroscopy or other additional
imaging. Once properly
positioned, as shown in FIG. 9F, the balloon 250 may be inflated to dilate
and/or otherwise treat the
obstruction 94. Optionally, the balloon 250 may carry one or more diagnostic
and/or therapeutic
agents, which may be delivered against and/or into the obstruction 94 using
the balloon 250. After
sufficient treatment, the balloon may be deflated, and the apparatus 10
removed from the body lumen
90, as shown in FIG. 9G.
Optionally, with any of the embodiments described herein, various balloon
configurations
may be provided. For example, turning to FIG. 10A, with additional reference
to the apparatus 250 of
FIG. 8, an exemplary cross-section of the apparatus 210, taken through the
balloon 250, is shown.
FIG. 10A shows the helical member 270 wound around the inner member 230 and
surrounded by the
expanded balloon 250. Thus, both the helical member 270 and the inner member
230 are disposed
within the interior 256 of the balloon 250. One of the disadvantages of such a
balloon 250 is that the
wall must be relatively thick since it is difficult to predict which areas of
the balloon wall are going to
contact and scrape along a wall of a target body lumen.
FIGS. 10B-10D show alternative embodiments of balloon or tubular constructions
that may
be provided for any of the embodiments described herein. These constructions
may be provided for
a balloon capable of inflation or for a tubular member capable of expansion to
an expanded helical
shape without being inflated. Exemplary embodiments of such devices are
disclosed in U.S. Patent
No. 4,762,130.
For example, as shown in FIG. 10B, a balloon or tubular member 250' is shown
that
includes a first lumen 251' that receives the inner member 230 and a second
lumen 253' that
receives the helical member 270 therein. When the tubular member 250 and
helical member 270
are compressed axially, the helical member 270 may expand radially outwardly
away from the
inner member 230, thereby directing surface region 280' radially outwardly
away from the inner
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member 230 since the surface region 280' is furthest from the first lumen
251.' Thus, because the
surface region 280' is likely to contact the wall of the body lumen when the
tubular member 250'
is expanded, the construction of the tubular wall may be varied to enhance
scraping and/or other
removal of obstructive material. For example, features may be integrally
molded or otherwise
formed in the wall of the tubular member 250,' e.g., that extend helically
around the tubular
member 250' adjacent the second lumen 253.'
As shown in FIG. 10B, the surface region 280' may include a plurality of
grooves that
provide edges 282' that may facilitate scraping adherent material from the
wall of the target body
lumen, e.g., by concentrating contact forces with the wall of the body lumen.
In addition, the
tubular wall opposite the surface region 280' may be relatively thin since
this area of the wall is
unlikely to contact the wall of the body lumen, which may allow an overall
cross-section or profile
of the tubular member 250' to be reduced. Alternatively, or in addition, if
desired, different property
materials may be used, e.g., harder elastomeric materials with relatively
thinner wall thickness for
the surface region 280' or elsewhere on the tubular member 250.'
Turning to FIG. 10C, another embodiment of a tubular member 250" is shown that
includes and ridges or protrusions 282" along surface region 280" that will
contact the wall of the
body lumen when the tubular member 250" is expanded. In a further alternative,
shown in FIG.
10D, a tubular member 250" may be provided that includes a first lumen 251"
having
convolutions molded or otherwise formed into the tubular wall. The
convolutions may increase
the circumferential length of the tubular wall, and therefore allow the wall
to stretch to a greater
radial dimension, yet still direct the surface region 280" towards the wall of
a body lumen being
treated.
Turning to FIG. 11, another embodiment of an apparatus 310 is shown that
includes an
outer member 320, an inner member 330, and an expandable member 350 carried on
distal ends
324, 334 of the outer and inner members 320, 330, similar to the previous
embodiments. Unlike
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the previous embodiments, the expandable member 350 may not include an
interior coupled to a
lumen extending through the outer member 320, i.e., the expandable member 350
may not be
inflatable. However, alternatively, if desired, the apparatus 310 may include
a lumen (not shown)
extending through the outer member 320 and communicating with an interior of
the expandable
member 350 for selectively inflating or collapsing the expandable member 350.
In addition, if
desired, the apparatus 310 may include one or more sealing members or other
valve (not shown) that
may be opened or closed for selectively infusing fluid or inflating the
expandable member 350,
similar to the previous embodiments.
The expandable member 350 generally includes a proximal end 352 coupled to the
outer
member distal end 324 and a distal end 354 coupled to the inner member distal
end 334, e.g., by
bonding with adhesive, sonic welding, fusing, interference fit, one or more
bands or other connectors
(not shown), and the like. In addition, the apparatus 310 includes a helical
member (not shown) that
may also be coupled between the outer member and inner member distal ends 324,
334 and extend
helically around the inner member 330 within the interior of the expandable
member 350.
For example, the helical member may be loose within the interior of the
expandable member
350. Alternatively, the helical member may be embedded in or otherwise
attached to the wall of the
expandable member 350, e.g., to an inner surface of the expandable member 350.
Unlike the previous embodiment, the helical member includes a first coil
within a first region
350a of the expandable member 350 and a second coil within a second region
350b of the expandable
member 350 having different properties. The first and second coils may be
coupled to one another,
e.g., integrally formed together as a single wire, filament, and the like, or
may be formed as separate
wires or filaments attached to one another. Each coil includes a plurality of
turns that extend helically
around the inner member 330, e.g., between the proximal and distal ends 352,
354 of the expandable
member 350.
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The coils may be provided in a relatively low profile around the inner member
330, e.g., when
the inner member 330 is extended distally relative to the outer member 320 to
a first position. When
the inner member 330 is retracted proximally from the first position towards a
second position, the
coils may be compressed axially, thereby causing the coils to expand radially
outwardly and expand
the expandable member 350 radially outwardly to an expanded helical shape,
similar to the previous
embodiments.
The coils may have different mechanical properties from one another, thereby
causing the first
and second regions 350a, 350b of the expandable member 350 to expand to
different sizes and/or
shapes in the expanded helical shape. For example, as shown in FIG. 11, the
first region 350a may be
expanded to a smaller diameter than the second region 350b. This may be
achieved by forming the first
coil from thinner, narrower, or otherwise more flexible material than the
second coil. In addition or
alternatively, the coils may be biased to different diameters such that when
the inner member 330 is in
the distal or first position, the coils may be constrained in the low profile,
and when the inner member
330 is directed proximally towards the second position, the coils may
resiliently expand radially
outwardly to the diameters set into the coil material.
In addition or alternatively, the coils may be expandable sequentially, e.g.,
such that the first
region 350a of the expandable member 350 may expand to the expanded helical
shape before the
second region 350b. For example, the first coil in the first region350a may
have less resistance to
expansion than the second coil in the second region 350b, e.g., by forming the
first coil from thinner,
narrower, and/or otherwise more flexible material than the second coil. For
example, the first coil may
include a bare wire wound helically around the inner member 330, while the
second coil may include
the same or different wire wrapped in a section of tubing, a sleeve, and the
like, which may increase
resistance to expansion. Thus, when the inner member 330 is directed from the
first position towards the
second position, the compressive force may be applied initially to the first
coil, thereby expanding the
first coil and the first region 350a of the expandable member 350, until a
predetermined threshold is
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achieved, whereupon the second coil may expand and expand the second region
350b of the expandable
member 350.
In another alternative, a sleeve (not shown) attached to the inner member 330
may initially
surround the second coil in the first position such that only the first coil
is free to expand when initially
compressed. When the inner member 330 is directed towards the second position,
the second coil may
become exposed from the sleeve, and then expand radially outwardly to the
expanded helical shape.
Turning to FIGS. 12 and 13, an exemplary method is shown for treating a body
lumen, e.g., a
arterio-venous dialysis graft 190, using the apparatus 310 of FIG. 11. As
shown, the graft 190
includes a first or venous anastomosis 192 attached to a vein 193 within a
patient's body, e.g., within
the patient's arm, and a second or arterial anastomosis 194 attached to an
artery 195 adjacent the vein
193. As shown, the graft 190 includes obstructive material 92, e.g., thrombus,
plaque, and the like
at multiple locations in the graft 190 including within each anastomosis 192,
194.
Initially, an introducer or guide sheath 380 may be placed within the graft
190, e.g.,
percutaneously through the patient's skin into a central region of the graft
190, using similar
methods to those described elsewhere herein. The sheath 380 may include a
distal end 382
having a size and/or shape for introduction into the graft 190 and a balloon
382 on the distal end
384 for substantially engaging a wall of the graft 190, e.g., to stabilize the
sheath 380 relative to
the graft 190 and/or to substantially seal the graft 190 from fluid flow
between the ends 192, 194
of the graft 190. The sheath 380 may also include a reservoir 386
communicating with a lumen
extending to an opening (not shown) in the distal end 382, and a source of
vacuum 388, e.g., a
syringe, for applying a vacuum to aspirate material from within the graft 190
during treatment.
The apparatus 310 may be introduced through the sheath 380 into the graft 190
with the
expandable member 350 initially in a contracted condition. As shown in FIG.
12, the apparatus 310
may be advanced until the expandable member 350 is disposed distally beyond
obstructive
materia192 within the venous Side of the graft 190, whereupon the inner member
330 (not shown)
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may be directed proximally to expand the expandable member 350 to the expanded
helical shape.
As shown, both coils have been expanded, thereby expanding both the first and
second regions
350a, 350b of the expandable member 350, e.g., such that the second region
350b may substantially
engage or otherwise contact the wall of the graft 190.
The apparatus 310 may then be withdrawn to scrape or otherwise separate
adherent material
92 from the wall of the graft 190 and pull the material 92 towards the sheath
380. The source of
vacuum 388 may be activated, if not already, to aspirate the material 92
through the sheath 380 into
the reservoir 386. If desired, the inner member 330 may be advanced to
collapse the expandable
member 350 back towards the contracted condition and advanced further into the
graft 190, e.g., to
repeat the process of expanding the expandable member 350 to scrape or
otherwise remove material
92.
Optionally, the sheath 380 may be repositioned within the graft 190 towards
the arterial
anastomosis 194, and the apparatus 310 reintroduced with the expandable member
350 in the
contracted condition, e.g., to remove material 92 within the arterial side of
the graft 190. Turning to
FIG. 13, although material has been removed from the graft 190, additional
obstructive material 92
remains within the arterial anastomosis 194. Because the anastomosis 194
communicates with the
artery 195, care should be taken to ensure that material is not released into
the artery 195, where the
material may flow into tissue beds, cause ischemia, or other damage to tissue
downstream of the
artery 195.
The apparatus 310 may be advanced until the distal end 334 of the inner member
330 passes
through material 92 within the arterial anastomosis 194 with the expandable
member 350 in the
contracted condition. At this point, the inner member 330 may be directed
proximally sufficient
distance to expand the first region 350a of the expandable member 350 without
substantially
expanding the second region 350b. The apparatus 310 may then be withdrawn to
pull the expandable
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member 350 back towards the sheath 380, where any material 92 removed from the
anastomosis 194
may be aspirated out of the graft 190. Thus, the smaller first region 350b may
allow greater care to
remove material from sensitive regions, while the second region 350b may be
expanded within
relatively large body lumens or otherwise when it is desired to apply greater
force and/or remove
greater amounts of material.
Turning to FIG. 14, an alternative embodiment of the apparatus 310 shown in
FIG. 11 is
shown. The apparatus 310 is generally the same as apparatus 310, e.g.,
including an outer member
320',' an inner member 330,' an expandable member 350', and first and second
coils defining a helical
member within the expandable member 350 including first and second regions
350a,' 350b,' similar to
the previous embodiments. Unlike the previous embodiment, the apparatus 310'
includes a dilation
balloon 359,' e.g., a substantially non-compliant, high pressure balloon, on
the outer member distal
end 324.' In addition the apparatus 310' includes a handle 360' that includes
a side port 364' to which
a source of inflation media and/or vacuum 368' may be connected.
The apparatus 310' may be used similar to the apparatus 310 shown in FIG. 11,
e.g., using
the methods of FIGS. 12 and 13. In addition, the dilation balloon 359' may be
positioned within a
stenosis, lesion, or other obstruction, e.g., in the graft 190 of FIGS. 12 and
13, or within other body
lumens. The balloon 359' may then be inflated or otherwise expanded to dilate
the body lumen,
similar to other embodiments described above. Optionally, a stent or other
prosthesis (not shown)
may be carried by the balloon 359,' e.g., such that the prosthesis may be
implanted within a body
lumen after using the balloon 350' to remove obstructive material from the
body lumen.
Alternatively, a stent or other prosthesis may be carried and delivered using
any of the other
embodiments described herein, e.g., on the balloon 150 or 250 of the apparatus
110 or 210, shown in
FIGS. 7 or 8.
Turning to FIGS. 15A and 15B, exemplary embodiments of coils are shown that
may be
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included in any of the apparatus described above including a helical member
for expanding a balloon
or other expandable member to an expanded helical shape. For example, FIG. 15A
shows a coil
370 that includes substantially smooth, uniform turns 372 that may be
incorporated as a helical
member in any of the apparatus described above. Alternatively, as shown in
FIG. 15B, a coil 370'
may be provided that includes a plurality of turns 372' having alternating
high points 374' and low
points 376' that may increase contact force with a wall of a body lumen when
the coil 370' is
included within a balloon or expandable member (not shown), such as those
described above. The
high and low points 374,' 376' may be staggered between adjacent turns, e.g.,
to ensure that at least
some high points 374' contact and/or scrape along substantially the entire
circumference of a wall of
a target body lumen.
Turning to FIG. 16, still another embodiment of an apparatus 410 is shown that
includes
multiple expandable devices on a single shaft, e.g., such that the apparatus
410 may be operable in
multiple modes, e.g., a first mode for removing material within a body lumen,
and a second mode for
dilating an obstruction within a body lumen.
Generally, the apparatus 410 generally includes an outer member 420, an inner
member 430,
a handle 460, and a first balloon or other expandable member 450 carried by
the outer and inner
members 420, 430, similar to the previous embodiments. The outer member 420
includes proximal
and distal ends 422, 424, and a first lumen 426 extending therebetween, and
the inner member 430
also includes proximal and distal ends 432, 434, and a second lumen 436
extending therebetween.
The first balloon 450 includes a proximal end 452 coupled to the outer member
distal end 424
and a distal end coupled to the inner member distal end 434, and includes an
interior communicating
with the first lumen 426. The first balloon 450 may be formed from elastic
material, e.g., such that
the first balloon 450 may be expanded to a range of diameters and/or shapes,
e.g., depending upon the
volume of inflation media delivered into the interior of the first balloon 450
and/or the position of
the inner member 430 relative to the outer member 420.
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In addition, a second balloon 459 may be provided on the outer member 420,
e.g., proximal to
the first balloon 450. The second balloon 459 may be formed from substantially
inelastic material,
e.g., to provide a non-compliant, high pressure dilation balloon, similar to
other embodiments
described elsewhere herein. The outer member 420 includes a third inflation
lumen 465
communicating with the interior of the second balloon 459.
As shown, the handle 460 includes a first side port 464a communicating with
the first lumen
426 for delivering inflation media into the first balloon 450, and a second
side port 464b
communicating with the third inflation lumen 465 for delivering inflation
media into the second
balloon 459. In addition, the handle 460 may include a pull handle or other
actuator 462 for directing
the inner member 430 to one or more axial positions relative to the outer
member 420, and one or
more seals, e.g., o-ring 466 for sealing the first lumen 426, similar to the
previous embodiments.
Turning to FIGS. 17A-17D, the apparatus 410 is shown in different modes with
the inner
member 430 in respective positions. First, as shown in FIG. 17A, the inner
member 430 is in a first
or distal position with the first and second balloons 450, 459 in contracted
conditions. In this
configuration, the apparatus 410 may be introduced into a patient's body, into
a target body lumen
being treated, similar to the previous embodiments.
Turning to FIG. 17B, the first balloon 450 has been inflated to an expanded
condition with
the inner member remaining in the first position. Thus, the first balloon 450
may be expanded to
one or more diameters, e.g., to engage or contact the wall of a body lumen
being treated. The
apparatus 410 may then be retracted or otherwise directed axially to scrape
the first balloon 450
along the wall, e.g., to remove thrombus or other adherent material from the
wall. Optionally, as
shown in FIG. 17C, if greater pressure is desired, or a larger balloon is
desired due to the size of the
body lumen, the pull handle 462 may be directed proximally to pull the inner
member 430
proximally relative to the outer member 420, thereby axially compressing and
radially expanding
the first balloon 450.
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Finally, as shown in FIG. 17D, if it desired to dilate a stenosis, lesion, or
other obstruction,
the first balloon 450 may be collapsed to the contracted condition, and the
second balloon 459 may
be positioned adjacent the obstruction and inflated to expand and dilate the
obstruction, similar to
the previous embodiments. Thus, the apparatus 410 may be used to different
treatments, e.g.,
embolectomy and/or angioplasty, without having to remove the apparatus 410,
similar to the
previous embodiments. The apparatus 410 may be tracked over a guidewire or
other rail received
through the second lumen 436 of the inner member 430, which may facilitate
directing the apparatus
410 to various positions within a body lumen during treatment.
Turning to FIG. 18, another embodiment of a balloon apparatus 510 is shown
that includes a
catheter body or other tubular member 520 including a proximal end (not
shown), a distal end 524
sized for introduction into a body lumen, and a plurality of lumens 526
extending between the
proximal end and the distal end 524. For example, the catheter body 520 may
include a guidewire
lumen 526a, e.g., sized for slidably receiving a guidewire or other rail (not
shown) therethrough, such
that the apparatus 510 may be advanced over a guidewire into a patients body.
In addition, the catheter body 520 may include an inflation lumen 526b that
may communicate
with a source of inflation media and/or source of vacuum (not shown) connected
to the proximal end
of the catheter body 520. A plurality of balloons or other expandable members
550 are spaced apart
on the distal end 524 that may be independently expandable. For example, the
balloons 550 may be
formed from substantially inelastic material, such that the balloons 550 may
be expanded to a
predetermined diameter. Thus, the balloons 550 may be non-compliant, high
pressure dilation
balloons, similar to the other embodiments described elsewhere herein.
For example, the balloons 550 may be configured such that the inflated
diameter and/or
length of the balloons 550 vary along the distal end 524 of the catheter body
520. As shown, in an
exemplary embodiment, the first balloon 550a may be expandable to a diameter
of seven millimeters
(7 mm), the second balloon 550b to a diameter of six millimeters (6 mm), the
third balloon 550c to a
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diameter of five millimeters (5 mm), and the fourth balloon 550d to a diameter
of four millimeters (4
mm). Thus, during use, the fourth balloon 550d may be initially positioned
within an obstruction and
inflated to dilate the obstruction. If further dilation is needed, the fourth
balloon 550d may be
deflated, the third balloon 550c may be positioned with the obstruction, and
inflated to further dilate
the obstruction. Thus, each successive balloon may be used, if desired, to
provide increasing dilation
of an obstruction.
The interior of each of the balloons 550 may communicate with the inflation
lumen 526b, i.e.,
such that the catheter body 520 includes only a single inflation lumen 526,
which may reduce the
overall profile of the catheter body 520. In order to selectively inflate one
of the balloons 550, a
valve member 570 may be provided within the inflation lumen 526b that may be
positioned such that
the inflation lumen or a lumen 576 within the valve member 570 communicates
with an interior of
only one of the balloons 550.
For example, as shown, the valve member 570 may include an outlet port 574 on
a distal end
572 of the valve member 570 that may communicate with the valve member lumen
576. The valve
member 570 may slidably but sealingly engage the catheter body 520, such that
the outlet port 574
may be aligned with an interior of a respective balloon 526. Thus, when
inflation media is delivered
through the valve member lumen 576, the inflation media may exit the outlet
port 574 and inflate
only the balloon 526 with which the outlet port 574 is aligned. It will be
appreciated that other valve
arrangements may be provided for delivering inflation media into the balloons
individually. For
example, a valve member (not shown) may be rotatable within the inflation
lumen 526b and may
include one or more outlet ports that are aligned with passages (also not
shown) into the interiors of
respective balloons 550 when the valve member is in a predetermined angular
orientation.
Turning to 19-21B, an exemplary embodiment of an apparatus 610 is shown for
removing,
retrieving, and/or otherwise capturing thrombus, objects, and/or obstructive
material within a body
lumen 90, such as a blood vessel, aorto-venous fistula, tubular graft, and the
like. Generally, the
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apparatus 610 includes a catheter, sheath, or other tubular member 620, and an
obstruction clearing or
fragmentor device 640 including one or more fragmentor loops or elements 650
carried by a
guidewire, shaft, or other elongate member 630.
As best seen in FIG. 19, the catheter 620 includes a proximal end 622, a
distal end 624 sized for
introduction into a body lumen, and a lumen 626 extending therebetween. The
proximal end 622 is
coupled to a handle 660 that includes an actuator for activating the
fragmentor device 640 and/or other
components of the apparatus 610. As shown, the handle 660 includes first and
second handle portions
662, 664 that are movably coupled to one another, e.g., by pin, hinge, or
other fulcrum 663, such that
the second handle portion 662 may pivot or otherwise move relative to the
first handle portion 662 to
actuate the apparatus 610.
The first handle portion 662 includes a housing 666 (shown schematically in
FIGS. 19 and 20)
carrying various components of the apparatus 610 and to which the proximal end
622 of the catheter
620 is attached or otherwise coupled. For example, the housing 666 may include
a piston assembly or
other source of vacuum 668 including a piston 669 slidable within a chamber
670 and communicating
with the lumen 626 of the catheter 620 via passage 671. The piston 669 may be
coupled to the second
handle portion 664 such that the piston 669 may be directed into and out of
the chamber 670 during
actuation of the second handle portion 664, e.g. to apply a vacuum to the
catheter 620 lumen for
aspirating material adjacent the catheter distal end 624. The housing 666
includes a reservoir 672 also
communicating with the lumen 626 via passage 671. The piston assembly 668 may
also provide
positive pressure to expel fluid or other material within the passage 671 into
the reservoir 672.
For example, as best seen in FIG. 20, a pair of one-way valves, e.g., duckbill
or other check
valves 673, 674, may be provided in the passage 671 for allowing flow of fluid
or other material
through the valves 673, 674 in only one direction. For example, inlet valve
673 may allow material to
enter the passage 671 from the catheter lumen 626 without allowing substantial
flow of material back
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into the lumen 626 from the passage 671. Outlet valve 674 may allow material
to flow from the passage
671 into reservoir 672 without allowing substantial flow of material back into
the passage 671.
Thus, when the piston 669 is drawn partially from the chamber 670, e.g., by
actuation of the
second handle portion 664, a vacuum may be created, opening the inlet valve
673 and creating a
vacuum within the catheter lumen 626, thereby aspirating material from beyond
the catheter distal end
624 through the lumen 626 into the passage 671. When the piston 669 is
advanced back into the
chamber 670, e.g., when the second handle portion 664 is released or reset, a
positive pressure is
created in the passage 671, the inlet valve 673 is closed and the outlet valve
674 is opened, thereby
forcing material within the passage 671 into the reservoir 672.
Returning to FIG. 19, the guidewire 630 generally includes a proximal end 632
extending into
the handle 660, e.g., coupled to the second handle portion 664, and a distal
end extending from the
lumen 626 of the catheter 620 distally beyond the distal end 624 of the
catheter 620. A seal 623 may be
provided in the handle 660, e.g., to accommodate movement of the guidewire 630
into and out of the
handle 660 and catheter 620 while preventing fluid from leaking from within
the lumen 626.
As best seen in FIG. 20, the proximal end 632 of the guidewire 630 may be
coupled to an
adjustment control 636, e.g., to adjust a distance the guidewire 630 is pulled
when the second handle
portion 664 is actuated. For example, as shown, the proximal end 632 of the
guidewire 630 may be
slidably received in a slot 637 and coupled to a jack screw 638. The jack
screw 638 may be coupled to a
control knob 639 such that rotation of the know causes the jack screw 638 to
move the proximal end
632 of the guidewire 630 up or down in the slot 637.
As the proximal end 632 of the guidewire 630 is directed upwardly in the slot
637, the proximal
end 632 becomes further from the fulcrum 663, thereby increasing the distance
the proximal end 632 of
the guidewire 630 moves when the second handle portion 664 is actuated and
released. As the proximal
end 632 is directed downwardly in the slot 637, the distance the proximal end
632 moves decreases
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when the second handle portion 664 is actuated and released. Movement of the
proximal end 632
causes the distal end 634of the guidewire 630 to move proximally and distally
relative to the catheter
distal end 624 for actuating the fragmentor device 640, as described further
below.
Turning to FIGS 21A and 21B, the fragmentor device 640 includes a pair of
loops 650,
although alternatively, the fragmentor device 640 may include additional
loops, e.g., even numbers such
that the loops may be coupled to the guidewire 630. As shown, a proximal edge
of the first loop 650a is
coupled to the catheter distal end 624 and an opposite distal edge is coupled
to a proximal edge of the
second loop 650 whose opposite distal edge is coupled to the guidewire 630,
e.g., at hub 633. Each of
these connections may be hinged, e.g., to allow the loops 650 to move
proximally and distally during
actuation. Optionally, the proximal edge of the first loop 650a may be
hingedly coupled to the catheter
distal end 624 at least partially within the lumen 626, e.g., to partially
draw the first loop 650a into and
out of the lumen 626 during actuation.
In addition, the fragmentor device 640 includes a fragmentor coil 642
including a first end 643
coupled to the catheter distal end 624, e.g., adjacent or within the lumen
626, and a second end 644
coupled to the guidewire 630, e.g., at hub 633. The fragmentor coil 642 may
extend helically around the
guidewire 630 between the first and second ends 632, 644, as best seen in FIG.
21B.
The fragmentor device 640 has two positions that it moves between during
actuation. For
example, FIG. 21A shows the fragmentor device 640 in a first or distal
position in which the guidewire
630 is extended distally relative to the catheter distal end 624.
Consequently, the fragmentor loops 650
and coil 644 are extended distally or longitudinally so that they adopt a low
profile, e.g., with the coil
644 compressed around the guidewire 630 and the loops 650 lying substantially
flat adjacent the
guidewire 630. When the second handle portion 664 is actuated, the guidewire
630 is pulled proximally,
thereby pulling the hub 633 on the distal end 634 and consequently compressing
the fragmentor loops
650 and coil 644 proximally so that they adopt a larger profile, e.g., with
the loops 650 adjacent one
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another and the coil 642 expanded away from the guidewire 630.
In the larger profile, the orientation of the loops 650 may approximate the
diameter or other
cross-section of a body lumen 90 within which the apparatus 610 is introduced,
as best seen in FIG.
21B. To adjust the maximum diameter or cross-section of the loops 650 in the
larger profile, the
adjustment control 636 on the handle 660 may be adjusted, e.g., to shorten the
guidewire 630 travel
distance and reduce the maximum diameter, or to extend the guidewire 630
travel distance and increase
the maximum diameter, as desired.
The distal end 634 of the core wire 630 may be substantially atraumatic, e.g.,
rounded or
otherwise shaped to minimize risk of perforation and/or catching during
advancement relative to the
catheter distal end 624 within a patient's body. Optionally, the distal end
634 may be covered by a
coiled wire and/or a polymeric covering, and/or may include a "J" or other
curved tip (not shown).
Optionally, the apparatus 610 may include one or more markers to facilitate
positioning and/or
advancement of the apparatus 610 during use. For example, one or more
radiopaque markers may be
placed on the catheter distal end 624, on the guidewire distal end 630, and/or
on the fragmentor device
640. For example, one or more of the loops 650 and/or coil 642 may be formed
from radiopaque or
other materials that may facilitate imaging the apparatus 610 during use,
similar to the previous
embodiments.
Turning to FIGS. 22A-22F, an exemplary method for removing thrombus or other
material 92
from within a body lumen 90 is shown. Initially, as shown in FIG. 22A, the
apparatus 610 may be
introduced into a patient's body and directed into a target body lumen 90.
Similar to previous
embodiments, the body lumen 90 may be a blood vessel, e.g., a vein or artery,
a graft, e.g., an aorto-
venous fistula, tubular xenograft, or synthetic tubular graft, and the like.
The apparatus 610 may be
introduced from a percutaneous puncture or other entry site and advanced
through any intervening body
passages into the body lumen 90. Optionally, the apparatus 610 may be
introduced through an
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introduced sheath, guide catheter, and the like (not shown). In addition or
alternatively, the apparatus
610 may be advanced over a guidewire or other rail (now shown), e.g., if the
catheter 620 or guidewire
630 includes a guidewire lumen (now shown).
As shown in FIG. 22A, the distal end 634 of the guidewire 630 has been
directed through a
mass of thrombus 92 such that the catheter distal end 624 is adjacent the
thrombus 92 and the
fragmentor device 640 at least partially contacts the thrombus 92. The
fragmentor device 640 may be
advanced along the thrombus 92 in the low profile, e.g., to reduce the risk of
breaking off pieces of the
thrombus 92 prematurely and/or pushing he thrombus 92 away from the catheter
distal end 624.
Turning to FIGS 22B and 22C, the fragmentor device 640 is shown being
actuated, e.g., such
that the loops 650 expand from the low profile at least partially across the
body lumen 90, and the coil
642 expands away from the guidewire 630, e.g., into the thrombus 92. As
described above with
reference to FIG. 20, to actuate the fragmentor device 640, the first and
second handle portions 662,
664 may be squeezed together, e.g., pivoting the second handle portion 664
relative to the first handle
portion 662 and pulling the proximal end 632 of the guidewire 630 proximally.
This pulls the distal end
of the guidewire 630, and consequently, the hub 663, loops 650, and coil 642
proximally, e.g., until the
larger profile shown in FIG. 22C is achieved. This motion of the loops 650 and
coil 642 may engage
and cut or otherwise separate one or more pieces of the thrombus 92 from the
main mass, as shown in
FIG. 22C.
In addition, as the second handle portion 664 is actuated, the piston 669 may
be drawn out of
the chamber 670, thereby creating a vacuum to aspirate pieces of the thrombus
92 into the catheter
lumen 626 and into the reservoir 672 (see FIG. 20). Alternatively, a syringe,
external continuous source
of vacuum, and the like (not shown) may be connected to the handle 660 to
aspirate material into the
catheter lumen 626, if desired, rather than using a self-contained apparatus
610, as shown. The
separated pieces of thrombus 92 may be sufficiently small to enter freely into
the catheter lumen 626
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and/or sufficient suction may be created to pull pieces of the thrombus 92
into the catheter lumen 626.
Turning to FIG 22D, actuation of the apparatus 610 may be released, e.g., by
releasing the
second handle portion 664. The handle 660 may include one or more springs or
other biasing
mechanisms (now shown) for automatically returning the second handle portion
664 to its original
position, and consequently returning the fragmentor device 640 to the distal
low profile. Because all of
the desired thrombus 92 may not have been removed, the user may again actuate
the fragmentor device
640, e.g., as shown in FIGS 22E and 22F, by again squeezing the handle 660 and
causing the loops 650
and coil 643 to compress axially and expand radially to separate additional
pieces of the thrombus 92
for aspiration into the catheter lumen 626. The process may be monitored using
external imaging, e.g.,
fluoroscopy, ultrasound imaging, and the like, until it is confirmed that
sufficient, e.g., substantially all
of the, thrombus 92 has been broken up and aspirated. Optionally, a source of
contrast (now shown)
may be connected to the apparatus 610, e.g., that communicates with the
catheter lumen 626 or a lumen
in the guidewire 630, to inject contract to facilitate imaging the thrombus 92
within the body lumen 90,
similar to the previous embodiments. Once the body lumen 90 is sufficiently
cleared, the apparatus 610
be directed to another body lumen or removed entirely from the patient's body.
It will be appreciated that elements or components shown with any embodiment
herein
are exemplary for the specific embodiment and may be used on or in combination
with other
embodiments disclosed herein.
While the invention is susceptible to various modifications, and alternative
forms,
specific examples thereof have been shown in the drawings and are herein
described in detail.
It should be understood, however, that the invention is not to be limited to
the particular forms
or methods disclosed, but to the contrary, the invention is to cover all
modifications,
equivalents and alternatives falling within the scope of the appended claims.
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