Note: Descriptions are shown in the official language in which they were submitted.
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METHOD AND DEVICE FOR SECLUDING A BODY VESSEL
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present application claims the benefit of priority of U.S.
Patent Application No.
15/929,937, filed on May 29, 2020, the contents of which are hereby
incorporated by reference
in its entirety for all purposes.
FIELD OF THE INVENTION
[0002] The following invention generally relates to the field of body
vessel seclusion.
BACKGROUND OF THE INVENTION
[0003] For certain medical conditions, it may be necessary or desirable to
seclude (i.e., to
close off, collapse, or significantly narrow) a body vessel such as a vein or
artery. One situation
in which seclusion may be desirable is in the treatment of varicose veins,
which are swollen,
twisted, or enlarged veins that may be visible under a patient's skin. By
closing off the varicose
vein, blood ceases to flow in the varicose vein and is naturally redirected to
healthy veins. Over
time, the closed-off vein may be completely absorbed into surrounding tissue.
[0004] There are several techniques currently in use for secluding a blood
vessel such as a
varicose vein. Examples of these techniques include surgery, heat ablation,
and chemical
treatment. Surgically, veins may be subjected to a seclusion procedure known
as ligation. During
ligation, a small incision may be made near the target vein and the vein may
be tied off. The
ligated vein may be left in place and absorbed into surrounding tissue, as
noted above.
Alternatively, the ligated vein may be removed by a process known as
"stripping" the vein. The
surgical treatment of veins in this manner is sometimes referred to as
phlebectomy.
[0005] The surgical treatment of varicose veins is generally effective, but
may carry certain
risks and disadvantages. The procedure is relatively invasive compared to
other varicose vein
treatment methods, and accordingly may be painful for some patients. Surgical
treatment of
varicose veins also carries a risk of nerve injury, may require the use of
general anesthesia and an
overnight hospital stay, and may require a relatively long recovery time.
Accordingly, other
types of vein treatment have been developed. These treatments generally
involve damaging the
walls of the vein, which causes the vein walls to collapse, close, or narrow.
For example, in heat
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ablation treatment, a heat source (typically a laser or radio frequency
transmitter) may be
inserted into the vein through a catheter. Upon reaching a target area of the
vein, the heat source
may be turned on for a predetermined period of time, which damages the target
area of the vein
and causes scar tissue to form on the inner walls of the vein. The build-up of
scar tissue closes
the vein. Problematically, the same heat that damages the vein can also damage
surrounding
tissue and nearby nerves. It can also cause skin burns and blood clots, and
may not be
appropriate for all types of veins.
[0006] The vein walls can also be damaged chemically in a procedure known
as
sclerotherapy. In sclerotherapy, a chemical known as a sclerosing agent may be
injected into the
vein. The sclerosing agent may damage the walls of the vein and cause the vein
to narrow or
close. However, in order to be effective, the sclerosing agent needs to remain
in contact with the
inside walls of the target area of the vein for some time (e.g., up to one
minute). This is difficult
to achieve using conventional sclerotherapy procedures because the sclerosing
agent may be
quickly washed away by the flow of blood through the vein. As a result, the
sclerosing agent
may be diluted and flow to other portions of the body, and hence the
sclerosing agent may not be
sufficiently effective to close the vein upon an initial application.
Accordingly, patients may
need several treatment sessions with one or more injections of sclerosing
agent applied in each
session. In order to address these issues, a new sclerotherapy treatment
method called catheter-
directed foam sclerotherapy ("CDFS") has recently been employed. In this
method, a catheter is
inserted into the vein and moved to the target site. The sclerosing agent is
injected into the vein
through the catheter in the form of a foam. Because the agent is a foam, it is
relatively more
difficult for the blood flow to dilute and remove the sclerosing agent.
Therefore, as compared to
conventional sclerotherapy, CDFS allows the sclerosing agent to be present at
the target site for a
relatively longer period of time, in a relatively larger concentration.
Nonetheless, the sclerosing
agent will still be washed away from the target site due to the flow of the
blood in the vein, so
repeated treatments may remain necessary.
[0007] Therefore there at least remains a need in the art for a method and
device for
secluding a body vessel such that a sclerosing agent may be maintained at the
target site without
being washed away due to blood flow in the vessel.
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SUMMARY OF THE INVENTION
[0008] One or more embodiments of the invention may address one or more of
the
aforementioned problems. In an example embodiment, a lumen assembly of a body
vessel
seclusion device is provided. The lumen assembly includes an aspiration port
lumen defining a
plurality of aspiration ports. The aspiration port lumen and the plurality of
aspiration ports being
configured to remove at least one of blood, a bodily fluid, a chemical agent
for permanently
secluding a body vessel, or any combination thereof from a treatment chamber
in a body vessel.
The lumen assembly also includes an injection port lumen defining a plurality
of injection ports.
The injection port lumen and the injection ports being configured to deliver
the chemical agent
for permanently secluding the body vessel to the treatment chamber. The lumen
assembly also
includes a proximal balloon lumen. The proximal balloon lumen being configured
to adjust an
inflation level of a proximal balloon. The lumen assembly further includes a
distal balloon
lumen. The distal balloon lumen being configured to adjust an inflation level
of a distal balloon.
The aspiration port lumen and the injection port lumen are disposed along a
first transverse axis,
and the proximal balloon lumen and the distal balloon lumen are disposed along
a second
transverse axis. The aspiration port lumen includes an aspiration port lumen
diameter, the
injection port lumen includes an injection port lumen diameter, the proximal
balloon lumen
includes a proximal balloon lumen diameter, the distal balloon lumen includes
a distal balloon
lumen diameter, and each of the aspiration port lumen diameter and the
injection port lumen
diameter are larger than each of the proximal balloon lumen diameter and the
distal balloon
lumen diameter.
[0009] In some embodiments, the first transverse axis is perpendicular to
the second
transverse axis. In some embodiments, the first transverse axis is vertical,
and the second
transverse axis is horizontal. In some embodiments, the plurality of
aspiration ports are evenly
spaced on the aspiration port lumen. In some embodiments, the aspiration port
lumen includes
three aspiration ports, and the injection port lumen includes four injection
ports. In some
embodiments, the three aspiration ports include a proximal aspiration port, an
intermediate
aspiration port, and a distal aspiration port, the four injection ports
include a first set of two
injection ports and a second set of two injection ports, the first set of two
injection ports is
disposed between the proximal aspiration port and the intermediate aspiration
port in the
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treatment chamber, and the second set of two injection ports is disposed
between the
intermediate aspiration port and the distal aspiration port in the treatment
chamber.
[0010] In some embodiments, at least one of the aspiration port lumen, the
injection port
lumen, the proximal balloon lumen, or the distal balloon lumen has a circular
cross-section. In
some embodiments, the lumen assembly has the same length as the body vessel
seclusion device.
In some embodiments, at least one of the aspiration port lumen and the
injection port lumen is
configured to receive a guide wire. In some embodiments, the proximal balloon
lumen and the
distal balloon lumen are configured to independently inflate the proximal
balloon and distal
balloon respectively.
[0011] In another example embodiment, a method of permanently secluding a
body vessel is
provided. The method includes adjusting an inflation level of a distal balloon
via a distal balloon
lumen. The method also includes adjusting an inflation level of a proximal
balloon via a
proximal balloon lumen. The method further includes removing blood from a
treatment chamber
in the body vessel via an aspiration port lumen having a plurality of
aspiration ports in fluid
communication with the treatment chamber. The method still further includes
delivering a
chemical agent to the treatment chamber via an injection port lumen having a
plurality of
injection ports in fluid communication with the treatment chamber. The method
also includes
removing the chemical agent from the treatment chamber via the aspiration port
lumen. The
aspiration port lumen and the injection port lumen are disposed along a first
transverse axis, and
the proximal balloon lumen and the distal balloon lumen are disposed along a
second transverse
axis. The aspiration port lumen includes an aspiration port lumen diameter,
the injection port
lumen includes an injection port lumen diameter, the proximal balloon lumen
includes a
proximal balloon lumen diameter, the distal balloon lumen includes a distal
balloon lumen
diameter, and each of the aspiration port lumen diameter and the injection
port lumen diameter
are larger than each of the proximal balloon lumen diameter and the distal
balloon lumen
diameter.
[0012] In some embodiments, the proximal balloon lumen and the distal
balloon lumen are
configured to independently inflate the proximal balloon and distal balloon
respectively. In some
embodiments, the first transverse axis is perpendicular to the second
transverse axis. In some
embodiments, the first transverse axis is vertical, and the second transverse
axis is horizontal. In
some embodiments, the plurality of aspiration ports are evenly spaced on the
aspiration port
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lumen. In some embodiments, the aspiration port lumen includes three
aspiration ports, and the
injection port lumen includes four injection ports. In some embodiments, the
three aspiration
ports include a proximal aspiration port, an intermediate aspiration port, and
a distal aspiration
port, the four injection ports include a first set of two injection ports and
a second set of two
injection ports, the first set of two injection ports is disposed between the
proximal aspiration
port and the intermediate aspiration port in the treatment chamber, and the
second set of two
injection ports is disposed between the intermediate aspiration port and the
distal aspiration port
in the treatment chamber.
[0013] In some embodiments, at least one of the aspiration port lumen, the
injection port, the
proximal balloon lumen, or the distal balloon lumen has a circular cross-
section. In some
embodiments, the lumen assembly has the same length as the body vessel
seclusion device. In
some embodiments, at least one of the aspiration port lumen and the injection
port lumen is
configured to receive a guide wire.
[0014] In one aspect, a device for secluding a body vessel is provided. In
accordance with
certain embodiments, the device may include a distal balloon, a proximal
balloon, an aspiration
port positioned adjacent to the distal balloon, an injection port positioned
adjacent to the
proximal balloon, and a lumen assembly. The lumen assembly may comprise a
central lumen, a
distal balloon lumen operably coupled to the distal balloon, a proximal
balloon lumen operably
coupled to the proximal balloon, an aspiration port lumen operably coupled to
the aspiration port,
and an injection port lumen operably coupled to the injection port. The distal
balloon and the
proximal balloon may define a treatment chamber therebetween, and the
aspiration port and the
injection port may be positioned within the treatment chamber on the lumen
assembly.
[0015] In another aspect, a method for secluding a body vessel is provided.
In accordance
with certain embodiments, the method may include removing blood from a
treatment chamber in
the body vessel via an aspiration port, delivering a chemical agent to the
treatment chamber via
an injection port, maintaining the chemical agent in the treatment chamber for
a predetermined
period of time to seclude the body vessel within the treatment chamber, and
removing the
chemical agent from the treatment chamber via the aspiration port. The
aspiration port may be
operably coupled to an aspiration port lumen of a vessel seclusion device, and
the injection port
may be operably coupled to an injection port lumen of the vessel seclusion
device.
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[0016] In yet another aspect, another method for secluding a body vessel is
provided. In
accordance with certain embodiments, the method may include selecting a
seclusion length of
the body vessel such that the seclusion length has a starting point and an
ending point, dividing
the seclusion length into at least two treatment chambers, secluding the first
treatment chamber
with a vessel seclusion device, moving the vessel seclusion device to the
second treatment
chamber, and secluding the second treatment chamber. The first treatment
chamber may be
defined by the starting point and a first intermediate point, and the second
treatment chamber
may be defined by the first intermediate point and the ending point. Secluding
each of the first
treatment chamber and the second treatment chamber may comprise removing blood
from the
treatment chamber in the body vessel via an aspiration port, delivering a
chemical agent to the
treatment chamber via an injection port, maintaining the chemical agent in the
treatment chamber
for a predetermined period of time to seclude the body vessel within the
treatment chamber, and
removing the chemical agent from the treatment chamber via the aspiration
port. The aspiration
port may be operably coupled to an aspiration port lumen of a vessel seclusion
device, and the
injection port may be operably coupled to an injection port lumen of the
vessel seclusion device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Exemplary embodiments now will be described more fully hereinafter
with reference
to the accompanying drawings, in which some, but not all embodiments of the
invention are
shown. The present invention may be embodied in many different forms and
should not be
construed as limited to the embodiments set forth herein; rather, these
embodiments are provided
so that this disclosure will satisfy applicable legal requirements and
demonstrate exemplary
embodiments of the invention. Repeat use of reference characters in the
present specification
and drawings is intended to represent same or analogous features or elements
of the invention.
[0018] FIG. 1 illustrates a partial view of a device for secluding a body
vessel in a pre-
deployed form according to an example embodiment;
[0019] FIG. 2 illustrates a device for secluding a body vessel including
the lumens according
to an example embodiment;
[0020] FIG. 3 illustrates a cross-section of a lumen assembly in a device
for secluding a body
vessel according to an example embodiment;
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[0021] FIG. 4 illustrates a partial view of a device for secluding a body
vessel in a deployed
form according to an example embodiment;
[0022] FIG. 5 illustrates a body vessel with an identified area to be
secluded according to an
example embodiment;
[0023] FIG. 6 illustrates a block diagram of a method of secluding a body
vessel according to
an example embodiment;
[0024] FIG. 7 illustrates a block diagram of a method of secluding a body
vessel according to
an example embodiment;
[0025] FIG. 8 illustrates a cross-section of another lumen assembly in a
device for secluding
a body vessel according to an example embodiment;
[0026] FIG. 9 illustrates a cross-section of yet another lumen assembly in
a device for
secluding a body vessel according to an example embodiment;
[0027] FIG. 10A illustrates a device for secluding a body vessel including
the lumens and a
marking system according to an example embodiment;
[0028] FIG. 10B illustrates the marking system and a reference point, such
as an introducer,
used according to an example embodiment;
[0029] FIG. 11 illustrates a block diagram of a method of secluding a body
vessel using the
marking system according to an example embodiment; and
[0030] FIG. 12 illustrates a partial view of a device for secluding a body
vessel in a deployed
form according to an example embodiment.
DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS
[0031] Reference will now be made in detail to exemplary embodiments of the
invention,
one or more examples of which are illustrated in the accompanying drawings.
Each example is
provided by way of explanation of the invention, not limitation of the
invention. In fact, it will
be apparent to those skilled in the art that modifications and variations can
be made in the
present invention without departing from the scope or spirit thereof. For
instance, features
illustrated or described as part of one embodiment may be used on another
embodiment to yield
a still further embodiment. Thus, it is intended that the present invention
covers such
modifications and variations as come within the scope of the appended claims
and their
equivalents.
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[0032] In contrast to conventional treatment methods and devices, the
exemplary
embodiments disclosed herein may be less invasive and may require less
recovery time.
Moreover, the exemplary embodiments disclosed herein may eliminate the need
for a general
anesthetic, instead relying on a local anesthetic. In this regard, the
exemplary embodiments
disclosed herein may reduce procedural risks and further decrease required
recovery time. In
addition, the exemplary embodiments disclosed herein may be associated with a
reduced risk of
nerve damage, skin damage, and recovery pain.
[0033] As used herein, the term "body vessel" may comprise any lumen or
other similar
region in a body, such as a blood vessel or the intestines. Although specific
examples are
provided herein with reference to veins, one of ordinary skill in the art will
recognize that the
device and methods disclosed herein are not limited to these particular
examples but rather may
be employed in any suitable body vessel.
[0034] The term "seclusion", as used herein, may refer to the narrowing,
collapsing, or
closing off of a body vessel. Accordingly, seclusion may be distinct from
therapies intended to
open or widen a vessel and from therapies intended to prevent the vessel from
narrowing. The
term "two-point seclusion", as used herein, may refer to secluding the body
vessel at two points
with a narrowed, collapsed, or closed space between the points.
[0035] For ease of reference, exemplary embodiments will be described in
terms of use in
human subjects. It will be understood, however, that such descriptions are not
limited to use to
humans, but will also include use in other animals unless explicitly stated
otherwise. Moreover,
although a catheter is referred to herein, one of ordinary skill in the art
will recognize that a
catheter is merely an exemplary device as disclosed herein.
[0036] In one aspect, a device for secluding a body vessel is provided. In
accordance with
certain embodiments, the device for secluding a body vessel may include a
distal balloon, a
proximal balloon, an aspiration port positioned adjacent to the distal
balloon, an injection port
positioned adjacent to the proximal balloon, and a lumen assembly. In some
embodiments, for
instance, the lumen assembly may comprise a central lumen, a distal balloon
lumen operably
coupled to the distal balloon, a proximal balloon lumen operably coupled to
the proximal
balloon, an aspiration port lumen operably coupled to the aspiration port, and
an injection port
lumen operably coupled to the injection port. In certain embodiments, for
example, the distal
balloon and the proximal balloon may define a treatment chamber therebetween,
and the
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aspiration port and the injection port may be positioned within the treatment
chamber on the
lumen assembly.
[0037] FIG. 1, for instance, illustrates a partial view of a device for
secluding a body vessel
in a pre-deployed form according to an example embodiment. As shown in FIG. 1,
for example,
the device may be a catheter. The catheter may include a lumen assembly 10, a
proximal balloon
20, an injection port 25 positioned adjacent to the proximal balloon 20, a
distal balloon 30, and
an aspiration port 35 positioned adjacent to the distal balloon 30. The
proximal balloon 20 and
the distal balloon 30 may define a treatment chamber 40 therebetween inside of
a body vessel 50
when the balloons 20, 30 are inflated. In this regard, for example, a chemical
agent may be
introduced into the treatment chamber 40 to seclude the body vessel 50 within
the treatment
chamber 40. The balloons 20, 30 may be made of any suitable material as
understood by one of
ordinary skill in the art including, but not limited, to polymeric materials.
In accordance with
certain embodiments, for example, the body vessel 50 may comprise at least one
of a varicose
vein, a portal vein, a perforator vein, a superficial vein, a peripheral vein,
an arteriovenous
malformation, or any combination thereof The catheter may be of any length
suitable for
secluding a variety of body vessels as understood by one of ordinary skill in
the art (e.g., 100
cm).
[0038] According to certain embodiments, for instance, the treatment
chamber 40 may
comprise a length from about 3 cm to about 15 cm. In some embodiments, for
example, the
treatment chamber 40 may comprise a length from about 5 cm to about 10 cm. In
further
embodiments, for instance, the treatment chamber 40 may comprise a length from
about 6 cm to
about 8 cm. In certain embodiments, for example, the treatment chamber 40 may
comprise a
length of about 7 cm. As such, in certain embodiments, the treatment chamber
40 may comprise
a length from at least about any of the following: 3, 4, 5, 6, and 7 cm and/or
at most about 15, 12,
10, 9, 8, and 7 cm (e.g., about 4-9 cm, about 6-12 cm, etc.).
[0039] The lumen assembly 10 may comprise a flexible tube having several
hollow lumens
therein as described in more detail below. The individual lumens may not be
very flexible. For
example, the individual lumens within the lumen assembly 10 may only bend
and/or move from
about 2 mm to about 3 mm. However, the lumen assembly 10 may be sufficiently
flexible to
navigate through the body vessels of an individual. For instance, the lumen
assembly 10 may be
used to guide the device into position inside the body vessel 50, for example,
via a guide wire 5.
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[0040] According to certain embodiments, for instance, the guide wire 5 may
comprise a
diameter from about .001 cm to about .025 cm. In some embodiments, for
example, the guide
wire 5 may comprise a diameter from about .01 cm to about .02 cm. In further
embodiments, for
instance, the guide wire 5 may comprise a diameter from about .015 cm to about
.019 cm. In
other embodiments, for example, the guide wire 5 may comprise a diameter of
about .018 cm.
As such, in certain embodiments, the guide wire 5 may comprise a diameter from
at least about
any of the following: .001, .005, .01, .015, .016, .017, and .018 cm and/or at
most about .025,
.024, .023, .022, .021, .02, .019, and .018 cm (e.g., about .01-.019 cm, about
.017-.024 cm, etc.).
However, the guide wire 5 may comprise any guide wire suitable for use with
the device
disclosed herein as understood by one of ordinary skill in the art.
[0041] In accordance with certain embodiments, for instance, the lumen
assembly 10 may
include the injection port 25 and the aspiration port 35 to introduce and
evacuate fluids
respectively. In certain embodiments, for example, the injection port 25 and
the aspiration port
35 may be positioned on the lumen assembly 10 within the treatment chamber 40
created by the
inflated proximal balloon 20 and the distal balloon 30. In some embodiments,
for example, each
of the aspiration port 35 and the injection port 25 comprise a port orifice
and a one-way valve at
the port orifice. In this regard, for instance, the aspiration port 35 may
evacuate blood and other
bodily fluids from the treatment chamber 40 to provide an empty area for the
chemical agent to
occupy and to prevent the chemical agent from being diluted. Additionally, the
aspiration port
35 may evacuate the chemical agent from the treatment chamber 40 after
treatment. Moreover,
the injection port 25 may introduce the chemical agent into the treatment
chamber 40 to initiate
seclusion of the body vessel 50.
[0042] FIG. 2, for instance, illustrates a device for secluding a body
vessel including the
lumens according to an example embodiment. As shown in FIG. 2, for example,
the lumen
assembly 10 divides into individual lumens outside of the body vessel 50. The
individual lumens
include a distal balloon lumen 11, a proximal balloon lumen 12, a central
lumen 13, an injection
port lumen 14, and an aspiration port lumen 15. FIG. 3, for instance,
illustrates a cross-section of
the lumen assembly 10 in a device for secluding a body vessel according to an
example
embodiment. As shown in FIG. 3, for example, the lumen assembly 10 channels
each of the
lumens 11-15 through a single tube such that the distal balloon lumen 11, the
proximal balloon
lumen 12, the injection port lumen 14, and the aspiration port lumen 15 are
arranged around the
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central lumen 13 such that the two balloon lumens 11, 12 are positioned
diagonally across from
each other within the lumen assembly 10. The two port lumens 14, 15 are
similarly positioned
diagonally across from each other within the lumen assembly 10.
[0043] According to certain embodiments, for example, the central lumen 13
is configured to
introduce the guide wire 5 into the body vessel 50. Prior to the guide wire 5
moving through the
central lumen 13, the body vessel 50 may be prepared. For example, an incision
in a patient's
skin may be made, and the body vessel 50 may be opened at the location of the
incision. The
guide wire 5 may then be inserted into the opening in the body vessel 50 and
threaded through
the body vessel 50 under guidance of a visualization device (e.g., ultrasound
95), as described in
more detail below. In various embodiments, the visualization device (e.g., an
ultrasound
transducer 95) may be used during the operation of the catheter. For example,
the ultrasound
transducer may be used to position the catheter within a body vessel. In
various embodiments,
one or more substances used in the catheter may be visible via ultrasound,
such that the
movement and operation of the body vessel seclusion system may be monitored in
real time
during operation. For example, the ultrasound transducer may be used to
monitor the contraction
and/or deflection of the body vessel in an instance in which the balloons are
inflated and the
treatment chamber is defined (e.g., a vein may deflect approximately 1 mm in
an instance in
which the vein is prepared for seclusion). When the guide wire 5 reaches the
appropriate
treatment point within the body vessel 50, the central lumen 13 may be
threaded over the guide
wire 5 and into the body vessel 50. The central lumen 13 (and similarly the
entire device) may
be pushed along the length of the guide wire 5 until the distal balloon 30 is
in a suitable location
in the body vessel 50 as indicated by the visualization device.
[0044] In various embodiments, the visualization device (e.g., an
ultrasound transducer 95)
may be used to monitor the operation of the body vessel seclusion system in
approximately real-
time. In various embodiments, the visualization device (e.g., the ultrasound
transducer) may
monitor the balloon inflation during operation (e.g., the balloons may be
filled with a substance
visible under an ultrasound, such as air). In various embodiments, the
visualization device (e.g.,
the ultrasound transducer) may be used to position the catheter within the
body vessel (e.g.,
originally for the first treatment chamber and/or during repositioning for
subsequent treatment
chambers). For example, the catheter may include a reflective substance such
that at least a
portion of the catheter may be visible via an ultrasound. In various
embodiments, the
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visualization device may be used to monitor the infusion and/or aspiration of
the chemical agent
into the body vessel during operation. For example, the chemical agent may be
visible by the
visualization device, such that the amount and/or distribution of chemical
agent in the body
vessel can be monitored (e.g., a doctor may, in some examples, be able to
determine when a
sufficient amount of chemical agent has been provided to the body vessel for
seclusion).
[0045] According to certain embodiments, for instance, the aspiration port
35 and the
aspiration port lumen 15 may be configured to remove at least one of blood,
bodily fluid, a
chemical agent, or any combination thereof from the treatment chamber 40. In
further
embodiments, for example, the injection port 25 and the injection port lumen14
may be
configured to deliver a chemical agent to the treatment chamber 40.
[0046] Moreover, according to certain embodiments, for instance, the
proximal balloon 20
and the distal balloon 30 may be inflated through the proximal balloon lumen
12 and the distal
balloon lumen 11 respectively. The balloons 20, 30 may be inflated using air
or any other
suitable fluid as understood by one of ordinary skill in the art. In this
regard, the inflation of the
balloons 20, 30 may secure the catheter in place and isolate the treatment
chamber 40.
[0047] FIG. 4, for example, illustrates a partial view of a device for
secluding a body vessel
in a deployed form according to an example embodiment. As shown in FIG. 4, for
instance, the
balloons 20, 30 are inflated to define the treatment chamber 40. To define the
treatment chamber
40, for example, the proximal balloon 20 and the distal balloon 30 may be
inflated with a fluid.
When inflated, for instance, the interior sides of the distal balloon 30 and
the proximal balloon
20 (i.e. the sides facing internally towards each other) may define the outer
limits (e.g., starting
point 60 and ending point 70) of the treatment chamber 40. For example, the
proximal and distal
balloons 20, 30 may be sized so that, when inflated, the outer ends of the
balloons 20, 30 contact
the interior surface of the body vessel 50 and form a seal, preventing fluids
from entering or
leaving the treatment chamber 40. According to certain embodiments, each of
the distal balloon
30 and the proximal balloon 20 are spherical. However, the balloons 20, 30 may
be any shape
suitable for use in the device as understood by one of ordinary skill in the
art.
[0048] In some embodiments, for instance, the distal balloon 30 may
comprise an inflated
distal balloon diameter, the proximal balloon 20 may comprise an inflated
proximal balloon
diameter, and each of the inflated distal balloon diameter and the inflated
proximal balloon
diameter may be from about 5 mm to about 20 mm. In further embodiments, for
example, each
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of the inflated distal balloon diameter and the inflated proximal balloon
diameter may be from
about 7 mm to about 15 mm. In other embodiments, for instance, each of the
inflated distal
balloon diameter and the inflated proximal balloon diameter may be from about
8 mm to about
12 mm. As such, in certain embodiments, each of the inflated distal balloon
diameter and the
inflated proximal balloon diameter may be from at least about any of the
following: 5, 6, 7, and 8
mm and/or at most about 20, 19, 18, 17, 16, 15, 14, 13, and 12 mm (e.g., about
6-18 mm, about
5-14 mm, etc.).
[0049] In another aspect, a method for secluding a body vessel is provided.
In accordance
with certain embodiments, the method may include removing blood from a
treatment chamber 40
in the body vessel 50 via an aspiration port 35, delivering a chemical agent
to the treatment
chamber 40 via an injection port 25, maintaining the chemical agent in the
treatment chamber 40
for a predetermined period of time to seclude the body vessel 50 within the
treatment chamber
40, and removing the chemical agent from the treatment chamber 40 via the
aspiration port 35.
The aspiration port 35 may be operably coupled to an aspiration port lumen 15
of a vessel
seclusion device (e.g., catheter), and the injection port 25 may be operably
coupled to an
injection port lumen 14 of the vessel seclusion device.
[0050] FIG. 6, for example, illustrates a block diagram of a method of
secluding a body
vessel 50 according to an example embodiment. As shown in FIG. 6, for
instance, the method
includes the initial steps of inserting a guide wire 5 into the body vessel 50
via a central lumen
13 of the vessel seclusion device at operation 110, inserting at least a
portion of the vessel
seclusion device into the body vessel 50 via the guide wire 5 at operation
120, positioning the
vessel seclusion device within the body vessel 50 via ultrasound 95 at
operation 130, and
inflating a distal balloon 30 and a proximal balloon 20 of the vessel
seclusion device within the
body vessel 50 to define the treatment chamber 40 at operation 140. The method
continues with
the primary treatment steps of removing blood from the treatment chamber 40 in
the body vessel
50 via an aspiration port 35 at operation 150, delivering a chemical agent to
the treatment
chamber 40 via an injection port 25 at operation 160, maintaining the chemical
agent in the
treatment chamber 40 for a predetermined period of time to seclude the body
vessel 50 within the
treatment chamber 40 at operation 170, and removing the chemical agent from
the treatment
chamber 40 via the aspiration port 35 at operation 180.
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[0051] In accordance with certain embodiments, for instance, the chemical
agent may be any
agent known to chemically damage the body vessel 50 into which the catheter
has been
introduced, thereby causing the body vessel 50 to narrow or close. In some
embodiments, for
example, the chemical agent may be a sclerosing agent typically used in
sclerotherapy including,
but not limited to, polidocanol, sotra-decol, hypertonic saline, or any other
chemical agent
suitable for damaging the vessel in the context of the sclerosing effect as
understood by one of
ordinary skill in the art. Alternatively or in addition, for instance, the
chemical agent may be an
agent known to elicit a biological response from the body vessel 50 into which
the catheter has
been introduced. In such embodiments, for example, the agent may be selected
so as to induce
the biological reaction substantially immediately after the catheter is
withdrawn from the
treatment chamber 40 (i.e. the body vessel 50 closes or narrows around the
catheter as the
catheter is withdrawn from the body vessel 50). In this regard, the body
vessel 50 may be caused
to immediately close following application of the chemical agent (as compared
to traditional
sclerotherapies, in which the vessel may take several days, or even several
weeks, to close
following application of the sclerosing agent).
[0052] According to certain embodiments, for example, after evacuating the
treatment
chamber 40 of all blood and/or other bodily fluids via the aspiration port
lumen 15 and the
aspiration port 35, a chemical agent may be introduced into the treatment
chamber 40 via the
injection port lumen 14 and injection port 25 and then maintained in the
treatment chamber 40
for a predetermined amount of time due to the inflated balloons 20, 30. In
some embodiments,
for instance, maintaining the chemical agent in the treatment chamber for the
predetermined
period of time may comprise maintaining the chemical agent in the treatment
chamber for up to
one minute (i.e. from about 1 second to about 60 seconds). As such, in certain
embodiments, for
instance, the chemical agent may be maintained in the treatment chamber for a
time from at least
about any of the following: 1, 5, 10, 20, 30, 40, 50, and 60 seconds and/or at
most 60 seconds
(e.g., about 5-60 seconds, about 30-60 seconds, etc.). In this regard, the
chemical agent remains
in contact with walls of the body vessel 50 in the treatment chamber 40 for a
sufficient amount of
time to seclude the body vessel 50 without being diluted or washed away by the
flow of fluid in
the body vessel 50 shortly after introduction of the chemical agent. After the
predetermined
period of time, the chemical agent may be removed from the body vessel 50 via
the aspiration
port 35 and the aspiration port lumen 15. If the treatment chamber 40 fully
encompassed the
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area to be secluded, the balloons 20, 30 may be deflated and the catheter may
be withdrawn from
the body vessel 50 through the original incision. The original incision in the
body vessel 50
and/or skin may then be closed (e.g., via sutures). In this regard, the body
vessel 50 may be
secluded between two points (e.g., the starting point 60 and the ending point
70 in FIG. 4).
[0053] Following treatment, a patient will typically be capable of walking
immediately and
can return home after the procedure (i.e. the patient does not need to remain
in a hospital
overnight). The body vessel 50 may be secluded immediately, as opposed to
conventional
sclerotherapy, which may require additional time following treatment and/or
multiple treatments
in order to seclude the body vessel 50, and the body vessel 50 may be absorbed
into surrounding
tissue over a period of several months. The patient may be scheduled for a
follow-up visit to
verify that the body vessel 50 has been properly secluded and absorbed. If a
problem is noted at
the follow-up visit, for instance, the patient may undergo another round of
treatment using the
methods and devices disclosed herein or may be treated using a different
method. In this regard,
the methods disclosed herein may be used in combination with other
conventional treatments.
[0054] In yet another aspect, another method for secluding a body vessel is
provided. In
accordance with certain embodiments, the method may include selecting a
seclusion length of
the body vessel such that the seclusion length has a starting point and an
ending point, dividing
the seclusion length into at least two treatment chambers, secluding the first
treatment chamber
with a vessel seclusion device (e.g., catheter), moving the vessel seclusion
device to the second
treatment chamber, and secluding the second treatment chamber. The first
treatment chamber
may be defined by the starting point and a first intermediate point, and the
second treatment
chamber may be defined by the first intermediate point and the ending point.
Secluding each of
the first treatment chamber and the second treatment chamber may comprise
removing blood
from the treatment chamber in the body vessel via an aspiration port,
delivering a chemical agent
to the treatment chamber via an injection port, maintaining the chemical agent
in the treatment
chamber for a predetermined period of time to seclude the body vessel within
the treatment
chamber, and removing the chemical agent from the treatment chamber via the
aspiration port as
previously discussed herein. The aspiration port may be operably coupled to an
aspiration port
lumen of a vessel seclusion device, and the injection port may be operably
coupled to an
injection port lumen of the vessel seclusion device.
[0055] Lumen Assembly without Guide Wire Lumen (FIG. 8)
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[0056] In some embodiments, the number of lumens in the lumen assembly 10
may be
different than shown in FIG. 2. In some embodiments, the lumen assembly 10 may
be configured
to function without the need for a central lumen that includes a guide wire.
In some
embodiments, the lumen assembly 10 may include a distal balloon lumen 11, a
proximal balloon
lumen 12, an injection port lumen 14, and an aspiration port lumen 15. FIG. 8,
for instance,
illustrates a cross-section of the lumen assembly 10 in a device for secluding
a body vessel
according to an example embodiment. As shown in FIG. 8, for example, the lumen
assembly 10,
including the distal balloon lumen 11, the proximal balloon lumen 12, the
injection port lumen
14, and the aspiration port lumen 15 may be arranged in a single tube. In
various embodiments,
the lumen assembly 10 may be made out of a single material. In various
embodiments, the lumen
assembly 10 may be extruded (e.g., an extruded plastic). In various
embodiments, each of the
distal balloon lumen 11, the proximal balloon lumen 12, the injection port
lumen 14, and the
aspiration port lumen 15 may be a bore hole through the extruded material
(e.g., a bore hole
through the extruded plastic). The lumen assembly 10, in some examples, may
have increased
structural integrity due to the position of the lumen bore-holes within the
lumen assembly 10. For
example, the material through which the bore holes are extruded may be
arranged to give the
lumen rigidity (i.e., the arrangement of the bore holes with respect to the
material may provide
additional lumen rigidity). In various embodiments, the larger diameter of the
injection port
lumen 14 and the aspiration port lumen 15 may be approximately perpendicular
to provide lumen
rigidity.
[0057] As shown in FIG. 8, in some embodiments, the aspiration port lumen
15 and the
injection port lumen 14 may be generally disposed along a first transverse
axis 800. In some
embodiments, the proximal balloon lumen 12 and the distal balloon lumen 11 may
be generally
disposed along a second transverse axis 810. In some embodiments, the first
transverse axis 800
and the second transverse axis 810 may be approximately perpendicular to one
another. For
example, in an instance the first transverse axis 800 is generally vertical,
the second transverse
axis 810 may be generally horizontal. In various embodiments, the first
transverse axis 800 and
the second transverse axis 810 may be defined along the cross-section of the
lumen assembly 10
(e.g., as shown in FIG. 8). In various embodiments, the lumen assembly 10 may
have a sufficient
rigidity, such that, in some examples, the lumen assembly 10 is resistant to
kinking, for example,
during insertion into and positioning within the body lumen.
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[0058] In some embodiments, at least one of the aspiration port lumen 15,
the injection port
lumen 14, the proximal balloon lumen 12, or the distal balloon lumen 11 may
have a circular, or
generally circular (e.g., an oval), cross-section. In some embodiments, the
aspiration port lumen
15 may have an aspiration port lumen diameter, the injection port lumen 14 may
have an
injection port lumen diameter, the proximal balloon lumen 12 may have a
proximal balloon
lumen diameter, and the distal balloon lumen 11 may have a distal balloon
lumen diameter. As
shown in FIG. 8, in some embodiments, each of the aspiration port lumen
diameter and the
injection port lumen diameter may be larger than each of the proximal balloon
lumen diameter
and the distal balloon lumen diameter. In some embodiments, at least one of
the aspiration port
lumen 15 or the injection port lumen 14 may be configured to receive a guide
wire. For example,
the guide wire may be received by one or both of the aspiration port lumen 15
or the injection
port lumen 14 and does not require a separate guide wire lumen.
Additional Example Lumen Assembly Configuration (FIG. 9)
[0059] FIG. 9 illustrates another example lumen assembly 10 configuration
including a distal
balloon lumen 11, a proximal balloon lumen 12, a guide wire lumen 13, an
injection port lumen
14, and an aspiration port lumen 15. As shown in FIG. 9, for example, the
lumen assembly 10,
including the distal balloon lumen 11, the proximal balloon lumen 12, the
guide wire lumen 13,
the injection port lumen 14, and the aspiration port lumen 15 may be arranged
in a single tube. In
some embodiments, the aspiration port lumen 15 and the injection port lumen 14
may be
generally disposed along a first transverse axis 800. In some embodiments, the
proximal balloon
lumen 12 and the distal balloon lumen 11 may be generally disposed along a
second transverse
axis 810. In some embodiments, the first transverse axis 800 and the second
transverse axis 810
may be approximately perpendicular to one another. For example, in a
configuration in which the
first transverse axis 800 is generally vertical, the second transverse axis
810 may be horizontal.
In some embodiments, the guide wire lumen 13 may be located generally in the
middle of the
lumen assembly 10. For example, the guide wire lumen 13 may be located at
approximately the
intersection of the first transverse axis 800 and the second transverse axis
810.
[0060] In some embodiments, at least one of the aspiration port lumen 15,
the injection port
lumen 14, the proximal balloon lumen 12, the distal balloon lumen 11, or the
guide wire lumen
13 may have a circular cross-section. In some embodiments, the aspiration port
lumen 15 may
have an aspiration port lumen diameter, the injection port lumen 14 may have
an injection port
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lumen diameter, the proximal balloon lumen 12 may have a proximal balloon
lumen diameter,
the distal balloon lumen 11 may have a distal balloon lumen diameter and/or
the guide wire
lumen 13 may have a guide wire lumen diameter. As shown in FIG. 9, in some
embodiments,
each of the aspiration port lumen diameter and the injection port lumen
diameter may be larger
than each of the proximal balloon lumen diameter, the distal balloon lumen
diameter, and the
guide wire lumen diameter. In some embodiments, the guide wire lumen diameter
may be
smaller than the proximal balloon lumen diameter or the distal balloon lumen
diameter. In
various embodiments, the size of the aspiration port lumen diameter and the
injection port lumen
diameter may provide more rigidity to the lumen assembly 10, such that the
guide wire lumen 13
does not have to be as large in order to provide similar rigidity compared to
a lumen assembly
with similar sized lumens, such as the lumen assembly shown in FIG. 2.
[0061] FIG. 7, for example, illustrates a block diagram of a method of
secluding a body
vessel according to an example embodiment. As shown in FIG. 7, for instance,
the method
includes selecting a seclusion length of the body vessel at operation 210,
dividing the seclusion
length into at least two treatment chambers at operation 220, secluding the
first treatment
chamber with a vessel seclusion device at operation 230, moving the vessel
seclusion device to
the second treatment chamber at operation 240, and secluding the second
treatment chamber at
operation 250. In this regard, if the seclusion length 100 extends beyond one
treatment chamber
40, the catheter may be partially withdrawn in order to reposition the
treatment chamber 40 at a
new location along the seclusion length 100.
[0062] According to certain embodiments, for instance, the seclusion length
100 may be
from about 3 cm to about 100 cm. In other embodiments, for example, the
seclusion length 100
may be from about 7 cm to about 90 cm. In further embodiments, for instance,
the seclusion
length 100 may be from about 15 cm to about 80 cm. In some embodiments, for
example, the
seclusion length 100 may be from about 60 cm to about 70 cm. As such, in
certain
embodiments, the seclusion length 100 may be from at least about any of the
following: 3, 5, 7,
10, 15, 20, 30, 40, 50, and 60 cm and/or at most about 100, 95, 90, 85, 80,
75, and 70 cm (e.g.,
about 5-70 cm, about 50-60 cm, etc.).
[0063] In accordance with certain embodiments, for example, the seclusion
length may
comprise at least three treatment chambers. In such embodiments, for instance,
the first
treatment chamber may be defined by the starting point and the first
intermediate point, the
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second treatment chamber may be defined by the first intermediate point and a
second
intermediate point, and a third treatment chamber may be defined by the second
intermediate
point and the ending point. FIG. 5, for instance, illustrates a body vessel
with an identified area
to be secluded according to an example embodiment. As shown in FIG. 5, for
example, the
seclusion length 100 is divided into three treatment chambers, with the first
treatment chamber to
be located between the starting point 60 and the first intermediate point 70,
the second treatment
chamber to be located between the first intermediate point 70 and the second
intermediate point
80, and the third treatment chamber to be located between the second
intermediate point 80 and
the ending point 90.
[0064] According to certain embodiments, moving the vessel seclusion device
comprises
positioning the vessel seclusion device within the body vessel 50 via
ultrasound 95. Ultrasound
95 may be used to position the vessel seclusion device because it is not
invasive and does not
require special equipment to be deployed on the catheter or guide wire 5.
[0065] In this regard, the catheter may initially be positioned such that
the treatment chamber
40 lies between the starting point 60 and the first intermediate point 70.
Following application of
the chemical agent between these points 60, 70, the catheter may be
repositioned so that the
distal balloon 30 is positioned at the first intermediate point 70 and the
proximal balloon 20 is
positioned at the second intermediate point 80. The method may be repeated
until the full
seclusion length 100 has been treated such that the proximal balloon 20 is
positioned at the
ending point 90.
[0066] Marking System
[0067] As shown in FIG. 10A, the lumen assembly 10 may have a plurality of
markers 1000-
1040 at least partially along the seclusion length 100, discussed above. In
some embodiments,
the plurality of markers 1000-1040 may be visible using an ultrasound. In some
embodiments,
the plurality of markers may be evenly spaced along the lumen assembly 10. In
various
embodiments, the spacing between given markers may be based on the distance
between the
distal balloon 30 and the proximal balloon 20. In some embodiments, the
spacing between a
starting point (e.g., a first marker) and an intermediate point (e.g., a
second marker) may be less
than the distance between the distal balloon 30 and the proximal balloon 20.
For example, the
distance between each marker may be approximately half of the distance between
the distal
balloon 30 and the proximal balloon 20. In some embodiments, the distance
between adjacent
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markers may be approximately 1 centimeter to 10 centimeters. In some
embodiments, the
distance between adjacent markers may be approximately 2 centimeters to 8
centimeters. In
some embodiments, the distance between adjacent markers may be approximately 7
centimeters
to 7.5 centimeters. In some embodiments, the distance between adjacent markers
may be
approximately 7 centimeters. In some embodiments, each marker may be
approximately 3
centimeters to 3.5 centimeters from the adjacent marker. In some embodiments,
each marker
may be approximately 3 centimeters from the adjacent marker. In various
embodiments, the
distance between adjacent markers may be dependent on the length of the
treatment chamber
(e.g., the distance between markers may be greater for a catheter with a
longer treatment
chamber).
[0068] In various embodiments, the position of the catheter may be based
with reference to
the position of the markers relative to a reference point. For example, as
shown in FIG. 10B, the
markers may be monitored (e.g., by ultrasound) at the location of the
introducer 1060, discussed
herein. In some embodiments, the reference point (e.g., the introducer 1060)
may be positioned
such that one of the markers aligns with the reference point in an instance in
which the catheter is
in the first treatment chamber location. As shown in FIG. 10B, in an instance
in which the
lumen assembly 10 is positioned at the first treatment chamber, one of the
markers of the lumen
assembly (e.g., marker 1040) may align with the end of the introducer 1060
disposed within the
body vessel. For example, the introducer 1060 may be placed into the body
vessel, in some
examples, to stretch the body vessel and the lumen assembly may be placed into
the body vessel
through the introducer 1060. In various embodiments, the introducer 1060 may
be placed at a
known position in the body vessel (e.g., via ultrasound), such that in an
instance in which the
lumen assembly is placed at the first treatment chamber, one of the markers
aligns with the end
of the introducer (e.g., as shown in FIG. 10B).
[0069] In various embodiments, as shown in FIG. 10A, the markers may have
different
thicknesses based on the location along the lumen assembly. For example, in an
instance in
which the distance between markers is approximately half of the distance
between the distal
balloon 30 and the proximal balloon 20, every other marker may be wider (e.g.,
markers 1000,
1020, 1040), such that the user may easily move the catheter from one
treatment chamber to
another. For example, in an instance in which the first treatment chamber is
positioned such that
a bold marker (e.g., marker 1040) is located at the reference point, in order
to move to a second
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treatment chamber, the catheter may be moved to a position at which the next
bold marker (e.g.,
marker 1020) is located at the reference point. Alternatively, in an instance
in which the first
treatment chamber is positioned such that a thinner marker (e.g., marker 1030)
is located at the
reference point, in order to move to a second treatment chamber, the catheter
may be moved to a
position at which the next thinner marker (e.g., marker 1010) is located at
the reference point.
[0070] In various embodiments, the plurality of markers 1000-1040 may be
used to
determine the placement of the lumen assembly within a body vessel during
operation. In various
embodiments, the method of permanently secluding a body vessel may include
treating a
plurality of treatment chambers along the body vessel, as discussed in FIG.
11.
[0071] Referring now to Block 1100 of FIG. 11, an example embodiment of the
method of
permanently secluding a body vessel includes selecting a seclusion length of
the body vessel, the
seclusion length having a starting point and an ending point. As discussed
above, the seclusion
length may depend on various factors. For example, the seclusion length may be
based on the
length of a body vessel to be treated (e.g., the body vessel seclusion device
may be capable of
treating a certain number of consecutive treatment chambers without removal
based on the
seclusion length).
[0072] Referring now to Block 1110 of FIG. 11, an example embodiment of the
method of
permanently secluding a body vessel includes dividing the seclusion length
into at least two
treatment chambers. In some embodiments, the at least two treatment chambers
of the seclusion
length include a first treatment chamber defined by the starting point and a
first intermediate
point and a second treatment chamber defined by the first intermediate point
and the ending
point. For example, as shown in FIG. 10A, the marker 1000 may be a starting
point, the marker
1010 may be a first intermediate point, and the marker 1020 may be a ending
point, such that
moving the body seclusion device in relation to such markers may result in
multiple treatment
chambers being treated.
[0073] Referring now to Block 1120 of FIG. 11, an example embodiment of the
method of
permanently secluding a body vessel includes visualizing the starting point
and the first
intermediate point via a plurality of marker bands disposed on a lumen
assembly of a vessel
seclusion device. In various embodiments, the location of the marker bands at
a given time may
be compared to a reference point along the body vessel (e.g., the incision
location into the body
vessel or the like). For example, in an instance in which the seclusion device
is within the body
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vessel, a given marker (e.g., the marker 1040 most proximal to the manifold
1050 shown in FIG.
10A) may be even with the incision point. In various embodiments, the distance
between the
incision point and the starting point of the body vessel may be determined
based on the number
of markers that are visible within the body vessel (e.g., visible via
ultrasound). For example, a
user may know the distance between markers and a set number of markers within
the body vessel
may indicate the distance from the incision point to the end of the lumen
assembly 10, the distal
balloon 30, and/or the proximal balloon 20.
[0074] Referring now to Block 1130 of FIG. 11, an example embodiment of the
method of
permanently secluding a body vessel includes positioning a distal balloon of
the vessel seclusion
device at the starting point and a proximal balloon of the vessel seclusion
device at the first
intermediate point. As stated in reference to Block 1120, the position of the
proximal balloon 20
and the distal balloon 30 may be determined via the marking system. In an
example embodiment,
the starting point may be the point farthest from the incision point that the
body vessel will be
secluded. As discussed herein, the seclusion device may then be successively
moved along the
body vessel as each portion is secluded in order to permanently seclude the
desired length of the
body vessel.
[0075] Referring now to Block 1140 of FIG. 11, an example embodiment of the
method of
permanently secluding a body vessel includes secluding the first treatment
chamber with the
vessel seclusion device. As discussed above, a treatment chamber is a portion
of the body vessel
defined between the proximal balloon 20, the distal balloon 30, and the walls
of body vessel. In
some embodiments, the balloons 20, 30 may be independently inflated to contact
the body
vessel, such that the treatment area may be defined therein. In some
embodiments, the body
vessel may be secluded by first removing blood or a bodily fluid from the
respective treatment
chamber via an aspiration port lumen 15 having a plurality of aspiration ports
35 in fluid
communication with the respective treatment chamber. In some embodiments, once
the blood or
a bodily fluid has been removed from the respective treatment chamber (e.g.,
the first treatment
chamber), a chemical agent may be delivered to the respective treatment
chamber via an
injection port lumen 14 having a plurality of injection ports 25 in fluid
communication with the
respective treatment chamber. In some embodiments, the chemical agent may be
kept in the
treatment chamber for a predetermined amount of time (e.g., up to one minute).
In some
embodiments, the chemical agent may be removed from the respective treatment
chamber via the
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aspiration port lumen 15 after the predetermined amount of time. In some
embodiments, the
proximal balloon 20 and the distal balloon may then be independently deflated
in order to move
the body seclusion device along the body vessel to define another treatment
chamber (e.g.,
adjacent the prior treatment chamber) or for the body seclusion device to be
removed from the
body vessel if the seclusion is complete. In various embodiments, the ability
to move and define
successive adjacent treatment chamber may allow for the seclusion of a length
of the body vessel
that is longer than the length of the treatment chamber.
[0076] Referring now to Block 1150 of FIG. 11, an example embodiment of the
method of
permanently secluding a body vessel includes visualizing the first
intermediate point and the
ending point via the plurality of marker bands disposed on the lumen assembly
of the vessel
seclusion device. In various embodiments, the visualization may be completed
via ultrasound.
For example, the user of the seclusion device may use an ultrasound device to
determine the
number of markers (e.g., marker 1000-1040) that are within the body vessel. In
some
embodiments, the visualization may be based on the position of the lumen
assembly in
comparison to the incision point. For example, the positioning from a first
treatment chamber to
the second treatment chamber may be completed by removing a section of the
lumen assembly
from the body vessel in order to move from one treatment chamber to another
treatment chamber
(e.g., a user may be able to identify the position of the treatment chamber
based on the number of
markers that are outside of the body vessel).
[0077] Referring now to Block 1160 of FIG. 11, an example embodiment of the
method of
permanently secluding a body vessel includes repositioning the distal balloon
of the vessel
seclusion device at the first intermediate point and the proximal balloon of
the vessel seclusion
device at the ending point. As discussed above, the movement of the proximal
balloon 20 and the
distal balloon 30 along the body vessel may be less than the distance between
the proximal
balloon 20 and the distal balloon 30.
[0078] Referring now to Block 1170 of FIG. 11, an example embodiment of the
method of
permanently secluding a body vessel includes secluding the second treatment
chamber with the
vessel seclusion device. In various embodiments, the seclusion of the second
treatment chamber
is accomplished using the same as the seclusion process of the first treatment
chamber discussed
in reference to Block 1140 above. In various embodiments, the first treatment
chamber and the
second treatment chamber may be overlapping. In some embodiments, the first
treatment
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chamber and the second treatment chamber may overlap by approximately 0.1
centimeters (cm)
to 1.5 cm. In some embodiments, the first treatment chamber and the second
treatment chamber
may overlap by approximately 0.25 cm to 1 cm. In some embodiments, the first
treatment
chamber and the second treatment chamber may overlap by approximately 0.5
centimeters. In
various embodiments, the overlapping of the treatment chambers may be based on
the spacing
between each marker (e.g., the overlap may be the difference between the
distance between the
balloons 20, 30 and the distance between the markers). In some embodiments,
there may be little
to no overlapping of treatment chambers, such that each treatment chamber
starts approximately
where the previous treatment chamber ended. In some embodiments, the steps
discussed herein
may be repeated, such that there are more than two treatment chambers (e.g., a
third treatment
chamber, a fourth treatment chamber, etc.), depending on the desired length of
the body vessel to
be treated.
[0079] FIG. 12 illustrates an additional lumen assembly in accordance with
an example
embodiment. In some embodiments, the lumen assembly 10 may have a plurality of
aspiration
ports 35 along the aspiration port lumen 14. In some embodiments, the lumen
assembly 10 may
have a plurality of injection ports 25 along the injection port lumen 15. In
some embodiments,
the plurality of injection ports 25 and/or the plurality of aspiration ports
35 may be distributed
between the proximal balloon 20 and the distal balloon 30. In some
embodiments, the aspiration
port lumen 14 may include three aspiration ports. For example, the aspiration
port lumen 14 may
include a proximal aspiration port 35a, an intermediate aspiration port 35b,
and a distal aspiration
port 35c. In some embodiments, the injection port lumen 15 may include four
injection ports. In
some embodiments, the injection port lumen 15 may include a first set of two
injection ports 25a
and a second set of two injection ports 25b. In some embodiments, the first
set of two injection
ports 25a is disposed between the proximal aspiration port 35a and the
intermediate aspiration
port 35b in the treatment chamber. In some embodiments, the second set of two
injection ports
25b is disposed between the intermediate aspiration port 35b and the distal
aspiration port 35c in
the treatment chamber. While the plurality of injection ports 25 and the
plurality of aspiration
ports 35 are discussed in reference to the example configuration shown in FIG.
12, other
configurations of the plurality of injection ports 25 and the plurality of
aspiration ports 35 may
be used.
[0080] Exemplary Embodiments
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[0081] Certain exemplary embodiments provide a device for secluding a body
vessel. For
instance, this device provides a less invasive, less damaging means for
secluding body vessels
having a reduced recovery time and that is less likely to require multiple
applications. In one
aspect, the device for secluding a body vessel includes a distal balloon, a
proximal balloon, an
aspiration port positioned adjacent to the distal balloon, an injection port
positioned adjacent to
the proximal balloon, and a lumen assembly. According to certain embodiments,
the lumen
assembly comprises a central lumen, a distal balloon lumen operably coupled to
the distal
balloon, a proximal balloon lumen operably coupled to the proximal balloon, an
aspiration port
lumen operably coupled to the aspiration port, and an injection port lumen
operably coupled to
the injection port. In some embodiments, the distal balloon and the proximal
balloon define a
treatment chamber therebetween, and the aspiration port and the injection port
are positioned
within the treatment chamber on the lumen assembly. In certain embodiments,
the treatment
chamber comprises a length from about 3 cm to about 15 cm. In further
embodiments, the
central lumen is configured to introduce a guide wire into the body vessel.
[0082] In accordance with certain embodiments, each of the aspiration port
and the injection
port comprise a port orifice and a one-way valve at the port orifice. In some
embodiments, the
aspiration port and the aspiration port lumen are configured to remove at
least one of blood,
bodily fluid, a chemical agent, or any combination thereof from the treatment
chamber. In
further embodiments, the injection port and the injection port lumen are
configured to deliver a
chemical agent to the treatment chamber.
[0083] According to certain embodiments, each of the distal balloon and the
proximal
balloon are spherical. In some embodiments, the distal balloon comprises an
inflated distal
balloon diameter, the proximal balloon comprises an inflated proximal balloon
diameter, and
each of the inflated distal balloon diameter and the inflated proximal balloon
diameter is from
about 5 mm to about 20 mm.
[0084] In another aspect, certain embodiments provide a method for
secluding a body vessel.
According to certain embodiments, the method includes removing blood from a
treatment
chamber in the body vessel via an aspiration port, delivering a chemical agent
to the treatment
chamber via an injection port, maintaining the chemical agent in the treatment
chamber for a
predetermined period of time to seclude the body vessel within the treatment
chamber, and
removing the chemical agent from the treatment chamber via the aspiration
port. In such
CA 03184469 2022-11-22
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embodiments, the aspiration port is operably coupled to an aspiration port
lumen of a vessel
seclusion device, and the injection port is operably coupled to an injection
port lumen of the
vessel seclusion device. In some embodiments, the body vessel comprises at
least one of a
varicose vein, a portal vein, a perforator vein, a superficial vein, a
peripheral vein, an
arteriovenous malformation, or any combination thereof
[0085] In accordance with certain embodiments, maintaining the chemical
agent in the
treatment chamber for the predetermined period of time comprises maintaining
the chemical
agent in the treatment chamber from about 1 second to about 60 seconds. In
some embodiments,
the chemical agent comprises a sclerosing agent.
[0086] In accordance with certain embodiments, the method further comprises
inserting a
guide wire into the body vessel via a central lumen of the vessel seclusion
device. In such
embodiments, the method further comprises inserting at least a portion of the
vessel seclusion
device into the body vessel via the guide wire. In further embodiments, the
method further
comprises positioning the vessel seclusion device with the body vessel via
ultrasound. In some
embodiments, the method further comprises inflating a distal balloon and a
proximal balloon of
the vessel seclusion device within the body vessel to define the treatment
chamber. In such
embodiments, inflating the distal balloon and the proximal balloon comprises
separately
inserting a fluid into the distal balloon via a distal balloon lumen and
inserting the fluid into the
proximal balloon via a proximal balloon lumen.
[0087] In yet another aspect, certain embodiments provide a method for
secluding a body
vessel. According to certain embodiments, the method includes selecting a
seclusion length of
the body vessel such that the seclusion length has a starting point and an
ending point, dividing
the seclusion length into at least two treatment chambers, secluding the first
treatment chamber
with a vessel seclusion device, moving the vessel seclusion device to the
second treatment
chamber, and secluding the second treatment chamber. In such embodiments, the
first treatment
chamber is defined by the starting point and a first intermediate point, and
the second treatment
chamber is defined by the first intermediate point and the ending point. In
some embodiments,
secluding each of the first treatment chamber and the second treatment chamber
comprises
removing blood from the treatment chamber in the body vessel via an aspiration
port, delivering
a chemical agent to the treatment chamber via an injection port, maintaining
the chemical agent
in the treatment chamber for a predetermined period of time to seclude the
body vessel within the
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treatment chamber, and removing the chemical agent from the treatment chamber
via the
aspiration port. In such embodiments, the aspiration port is operably coupled
to an aspiration
port lumen of a vessel seclusion device, and the injection port is operably
coupled to an injection
port lumen of the vessel seclusion device. According to certain embodiments,
moving the vessel
seclusion device comprises positioning the vessel seclusion device within the
body vessel via
ultrasound.
[0088] In accordance with certain embodiments, the seclusion length
comprises at least three
treatment chambers. In such embodiments, the first treatment chamber is
defined by the starting
point and the first intermediate point, the second treatment chamber is
defined by the first
intermediate point and a second intermediate point, and a third treatment
chamber is defined by
the second intermediate point and the ending point.
[0089] These and other modifications and variations to the invention may be
practiced by
those of ordinary skill in the art without departing from the spirit and scope
of the invention,
which is more particularly set forth in the appended claims. In addition, it
should be understood
that aspects of the various embodiments may be interchanged in whole or in
part. Furthermore,
those of ordinary skill in the art will appreciate that the foregoing
description is by way of
example only, and it is not intended to limit the invention as further
described in such appended
claims. Therefore, the spirit and scope of the appended claims should not be
limited to the
exemplary description of the versions contained herein.
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