Note: Descriptions are shown in the official language in which they were submitted.
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DRAIN WITH OCCLUSION REMOVING STRUCTURE
CROSS-REFERENCE TO RELATED APPLICATIONS
This Application claims priority from International Patent Application No.
PCT/US05/00508 titled "Drain with Occlusion Removing Structure," filed January
7,
2005, the contents of which are incorporated in this disclosure by reference
in their
entirety.
BACKGROUND
There are a variety of medical drains, such as Penrose and Jackson-Pratt
drains,
used post-operatively to control blood and serosanguinous discharge from
operative sites
and wounds. Drains are typically used following major open abdominal
operations, as well
as during operations involving the back, breast, chest, head, hip and
vertebral column.
Drains help prevent the accumulation of hematomas and seromas in post-
operative sites that
lead to infections, abscesses, poor wound healing and wound dehiscence.
Medical drains generally have a distal end that is placed in the surgical site
and a
proximal end that is brought through the skin through a stab incision adjacent
to the closed
surgical incision. The proximal end of the drain is usually secured to the
skin by one or
more sutures.
Further, the proximal end of the drain is typically connected to a suction
device,
such as a compressible egg-shaped, container or bulb (a "hand grenade").
Connecting the
suction device to the drain applies negative pressure through the drain and
into the surgical
site, encouraging the egress of fluid from the surgical site through the
drain. The suction
device is emptied of drainage fluid, and the amount of drainage is measured
periodically,
such as per nursing shift or per day. The drain is removed when the amount of
drainage
diminishes below a set amount during a specific time.
Disadvantageously, however, medical drains are prone to occlusion with
inspissated
bloody or serosanguinous drainage, allowing fluids to collect at the surgical
site. When a
drain occludes, it must be replaced, either by an open surgical procedure or
by a minimally
invasive surgical procedure, such as, for example, a procedure involving
interventional
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radiology. Drain replacement procedures add significant extra expense and
increase the
risk of patient morbidity during the patient's post-operative course.
Therefore, there is a need for a new device or method that addresses the issue
of
occluded drains that involves less expense or less risk to the patient.
SUMMARY
According to one embodiment of the present invention, there is provided a
drainage
device for draining a space or cavity defined by a wall. The drainage device
comprises:
a) a first component comprising a proximal segment, an intermediate segment
and a distal
segment, where the intermediate segment and the distal segment function as an
occlusion
removing structure; and b) a second component that functions as a drain; where
the
drainage device comprises a proximal end and a distal end; where the proximal
end of the
proximal-segment comprises an instrument for creating an opening in the wall
of the space
or cavity; where the intermediate segment comprises a proximal end and a
distal end, and
further comprises a hollow tube comprising a wall with an outer surface and an
inner
=surface defining a central lumen; where the distal segment comprises an
elongated tubular
mesh comprising a proximal end, a distal end, an outer surface and an inner
surface
defining a central lumen; where the second component comprises a proximal end
and a
distal end, and further comprises a hollow tube comprising a wall with an
outer surface and
an inner surface defining a central lumen; where the first component and the
second
component are non-integrally connected; where the first component further
comprises a
proximal segment comprising a proximal end and a distal end; where the distal
end of the
proximal *segment is connected to the proximal end of the intermediate
segment; and where
the distal end of the intermediate segment is connected to the proximal end of
the distal
segment. In one embodiment, the instrument is a trocar. In another embodiment,
the
instrument is bent or curved along its longitudinal axis. In one embodiment,
the distal end
of the proximal segment comprises a first connector for joining the proximal
segment to the
intermediate segment. In another embodiment, the inner surface of the wall of
the hollow
tube of the intermediate segment fits snugly over the distal end of the first
connector of the
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proximal segment. In one embodiment, the first connector integrally joins the
proximal
segment to -the intermediate segment.
According to another embodiment of the present invention, there is provided a
drainage device for draining a space or cavity defined by a wall. The drainage
device
comprises: a) a first component comprising an intermediate segment and a
distal segment;
and b) a second component that functions as a drain; where the drainage device
comprises a
proximal end and a distal end; where the intermediate segment comprises a
proximal end
and a distal end, and further comprises a hollow tube comprising a wall with
an outer
surface and an inner surface defining a central lumen; where the distal
segment comprises
an elongated tubular mesh comprising a proximal end, a distal end, an outer
surface and an
inner surface defining a central lumen; where the second component comprises a
proximal
end and a distal end, and further comprises a hollow tube comprising a wall
with an outer
surface and an inner surface defining a central lumen; where the first
component and the
second component are non-integrally connected; and where the distal end of the
intermediate segment is connected to the proximal end of the distal segment.
In one
embodiment, the method further comprises creating a second opening using an
instrument
separate from the drainage device. In another embodiment, the method further
comprises
closing the second opening after withdrawing the second component.
According to another embodiment of the present invention, there is provided a
drainage device for draining a space or cavity defined by a wall. The drainage
device
comprises means for drainage and means for removing an occlusion.
In one embodiment, the drainage device further comprises a proximal end, a
distal
end, and a drainage device axial length between the proximal end of the
drainage device
and the distal end of the drainage device; and where the first component
extends
substantially from the proximal end of the drainage device to the distal end
of the drainage
device.
In one embodiment, the distal end of the intermediate segment comprises a
second
connector for joining the intermediate segment to the second component non-
integrally.
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In one embodiment, the proximal end of the distal segment is integrally joined
to the
distal end of the intermediate segment.
In one embodiment, the hollow tube of the second component is flexible.
In one embodiment, the hollow tube of the intermediate segment is flexible.
In one embodiment, the hollow tube of the second component further comprises a
plurality of apertures extending completely through the wall of the hollow
tube of the
second component, from the outer surface of the hollow tube of the second
component to
the inner surface of the hollow tube of the second component. In a preferred
embodiment,
the plurality of apertures are arranged in a plurality of rows.
In one embodiment, the second component further comprises a third connector at
the proximal end of the second component; and where the third connector is
configured to
mate non-integrally with the second connector on the distal end of the
intermediate
segment.
In one embodiment, the distal segment of the first component has a distal
segment
axial length extending from the proximal end of the tubular mesh to the distal
end of the
tubular mesh; where the second component has a second component axial length
extending
from the proximal end of the second component to the distal end of the second
component;
and where the distal segment axial length is between 60% and 100% of the
second
component axial length. In another embodiment, the distal segment of the first
component
has a distal segment axial length extending from the proximal end of the
tubular mesh to the
distal end of the tubular mesh; where the second component has a second
component axial
length extending from the proximal end of the second component to the distal
end of the
second component; and where the distal segment axial length is between 70% and
100% of
the second component axial length. In another embodiment, the distal segment
of the first
component has a distal segment axial length extending from the proximal end of
the tubular
mesh to the distal end of the tubular mesh; where the second component has a
second
component axial length extending from the proximal end of the second component
to the
distal end of the second component; and where the distal segment axial length
is between
80% and 100% of the second component axial length. In another embodiment, the
distal
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segment of the first component has a distal segment axial length extending
from the
proximal end of the tubular mesh to the distal end of the tubular mesh; where
the second
component has a second component axial length extending from the proximal end
of the
second component to the distal end of the second component; and where the
distal segment
5 axial length is between 90% and 100% of the second component axial length.
In another
embodiment, the distal segment of the first component has a distal segment
axial length
extending from the proximal end of the tubular mesh to the distal end of the
tubular mesh;
where the second component has a second component axial length extending from
the
proximal end of the second component to the distal end of the second
component; and
where the distal segment axial length is between 95 % and 100 % of the second
component
axial length. In another embodiment, the distal segment of the first component
has a distal
segment axial length extending from the proximal end of the tubular mesh to
the distal end
of the tubular mesh; where the second component has a second component axial
length
extending from the proximal end of the second component to the distal end of
the second
component; and where the distal segment axial length is between 99 % and 100 %
of the
second component axial length.
In one embodiment, the drainage device further comprises a third component
comprising a proximal end, a distal end, and a hollow tube comprising a wall
with an outer
surface and an inner surface defining a central lumen; and where the proximal
end of the
proximal segment fits snugly into the central lumen of the third component;
and where the
third component is non-integral with the first component. In another
embodiment, the
hollow tube of the third component is flexible.
In one embodiment, the drainage device further comprises one or more than one
structure for securing the drainage device connected to the proximal end of
the second
component: In another embodiment, the one or more than one structure is a
loop.
According to another embodiment of the present invention, there is provided a
kit
for removing an occlusion from an occluded drain comprising a drainage device
according
to the present invention, and further comprising an introducer. In one
embodiment, the
introducer comprises a replacement occlusion removing structure. In one
embodiment, the
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occlusion removing structure comprises a tubular mesh. In another embodiment,
the
tubular mesh is preloaded into the introducer.
According to another embodiment of the present invention, there is provided a
method for draining a cavity or space with a drain, and unoccluding the drain.
The method
comprises : a) selecting a space or cavity to be drained, where the space or
cavity comprises
a wall substantially defining the space or cavity to be drained; b) providing
a drainage
device according to the present invention; c) placing the distal end of the
drainage device
within the space or cavity to be drained through a first opening; d) using the
proximal end
of the proximal segment to create a second opening in the wall of the space or
cavity to be
drained, and advancing the proximal segment completely through the second
opening
created in the wall, before or after placing the distal end of the drainage
device within the
space or cavity to be drained through a first opening; e) allowing the distal
end of the
second component of the drainage device to remain in place for an extended
period of time
in order to drain drainage material from the space or cavity into the central
lumen of the
tubular mesh; f) allowing the second component to become occluded with
drainage
material; and g) withdrawing the tubular mesh proximally from the second
component,
thereby binding the occluding drainage material within the tubular mesh, and
thereby
unoccluc_'~ng the second component.
According to another embodiment of the present invention, there is provided a
method for draining a cavity or space with a drain, and unoccluding the drain.
The method
coniprises: a) selecting a space or cavity to be drained, where the space or
cavity comprises
a wall substantially defining the space or cavity to be drained; b) providing
a drainage
device according to the present invention; c) placing the distal end of the
drainage device
within the space or cavity to be drained through a first opening; d) allowing
the distal end
of the second component of the drainage device to remain in place for an
extended period
of time in order to drain drainage material from the space or cavity into the
central lumen
of the tubular mesh; e) allowing the second component to become occluded with
drainage
nlaterial; f) withdrawing the tubular mesh proximally from the second
component, thereby
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binding the occluding drainage material within the tubular mesh, and thereby
unoccluding
the second component.
In one embodiment, the space or cavity is within a human. In another
embodiment,
the space or cavity is created by a surgical procedure.
In one embodiment, the first opening is a naturally existing opening. In
another
embodiment, the first opening is a man-made opening. In another embodiment,
the first
opening is a surgical incision.
In one embodiment, withdrawing the tubular mesh proximally comprises rotating
the intermediate segment relative to the second component, and then by axially
sliding the
intermediate segment proximally relative to the second component.
Iin one embodiment, the method further comprises separating the proximal
segment
of the first component from the intermediate segment after creating the second
opening in
the wall of the space or cavity.
In one embodiment, the drainage device further comprises a third component
comprising a proximal end, a distal end, and a hollow tube comprising a wall
with an outer
surface and an inner surface defining a central lumen; and where the proximal
end of the
proximal segment fits snugly into the central lumen of the third component;
where the third
component is non-integral with the first component; and where the method
further
comprises removing the third component by axially sliding the third component
proximally
relative to the first component.
In one embodiment, the first opening through which the distal end of the
drainage
device is placed is closed after placing the distal end of the drainage device
within the space
or cavity. In another embodiment, the first opening is closed by suturing or
stapling.
In one embodiment, the method further comprises withdrawing the second
component from the space or cavity after withdrawing the tubular mesh
proximally from
the second component.
In one embodiment, the drainage device further comprises one or more than one
structure for securing the drainage device connected to the proximal end of
the second
component; and the method further comprises attaching the one or more than one
structure
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to a surface to anchor the drainage device. In another embodiment, the method
further
comprises detaching the one or more than one structure from the surface before
withdrawing the second component. In one embodiment, the method further
comprises
closing the second opening after withdrawing the second component.
In one embodiment, the method further comprises attaching the proximal end of
the
intermediate segment to a suction device after placing the distal end of the
drainage device
in the space or cavity. In another embodiment, the method further comprises
attaching the
proximal end of the second component to a suction device after withdrawing the
tubular
mesh.
In one embodiment, the method further comprises cutting the distal end of the
drainage device before placing the drainage device within the space or cavity.
In another
embodiment, cutting the distal end of the drainage device causes the cut
distal end of the
tubular mesh to retract slightly into the cut distal end of the second
component, thereby
preventing sharp points of the distal end of the tubular mesh from damaging
the wall of the
space or cavity during use of the drainage device.
In one embodiment, the method further comprises providing a replacement
occlusion removing structure, and inserting the replacement occlusion removing
structure
into the second component after unoccluding the second component. In another
embodiment, the method further comprises repeating the step of providing a
replacement
occlusion removing structure, and inserting the replacement occlusion removing
structure
into the second component after unoccluding the second component. In another
embodirnent, providing a replacement occlusion removing structure, and
inserting the
replacement occlusion removing structure into the second component after
unoccluding the
second component comprises: a) providing an introducer comprising a proximal
end and a
distal end; b) loading the replacement occlusion removing structure into an
introducer to
create a loaded introducer; c) inserting the distal end of the introducer
containing the
replacement occlusion removing structure into the proximal end of the second
component.
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FIGURES
These and other features, aspects and advantages of the present inventioin
will
become better understood with regard to the following description, appended
claims, and
accompa:uying figures where:
Figure 1 is a top perspective view of one embodiment of a drainage device
according to the present invention comprising a drain witli an occlusion
removing structure;
Figure 2 is a partial, close-up, lateral perspective view of the drainage
device shown
in Figure 1;
Figure 3 is a close-up lateral perspective view of the second component of the
drainage device shown in Figure 1 and Figure 2;
Figure 4 is a lateral perspective view of an alternate embodiment of the
drainage
device according to the present invention;
Figure 5 is a top perspective view of the optional third component of the
drainage
device as shown in Figure 1 and Figure 2;
Figure 6 is a lateral perspective view of an introducer according to the
present
invention;
Figure 7 is a bottom perspective view of the introducer shown in Figure 6;
Figure 8, is a lateral perspective view of an introducer preloaded with a
replacement
occlusion removing structure according to the present invention; and
Figure 9 through Figure 15 show partial cutaway, lateral perspective views of
various steps in a method of removing an occlusion from an occluded drain
according to the
present invention.
DESCRIPTION
According to one embodiment of the present invention, there is provided a
drainage
device comprising an occlusion removing structure. According to another
embodiment of
the present invention, there is provided a method for draining a cavity or
space with a
drain, and unoccluding the drain. In a preferred embodiment, the method
comprises
providing a device according to the present invention. The device and method
prolong the
useful life of a drain, such as a medical drain, and obviate the need for
replacing the drain
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when it becomes occluded, thereby decreasing the cost associated with drain
replacement,
and the risk of patient morbidity associated with drain replacement. Though
the drainage
device of the present invention is presented primarily in the context of a
medical drain in
this disclosure, the drainage device can also be used for other non-surgical
purposes, as
5 will be understood by those with skill in the art with reference to this
disclosure. The
device and method will now be presented in detail.
As used in this disclosure, the term "comprise" and variations of the term,
such as
"comprising" and "comprises," are not intended to exclude other additives,
components,
integers or steps.
10 As used in this disclosure, two elements of a device are"integral" if they
are joined
together in a manner that does not allow separation of the two elements from
one another
by the user of the device without cutting through or destroying the element.
As used in this disclosure, two elements of a device are"non-integral" if they
are
joined together in a manner to allow separation of the two elements from one
another by the
user of the device without cutting through or destroying the element.
As used in this disclosure, the term "occlude" and variations of the term,
such as
"occluded," "occluding," and "occlusion" means a mass or clog of occluding
material
within the central lumen of a drain, which either partially or completely
decreases the
function of a drain. As will be understood by those with skill in the art with
reference to
this disclosure, debris being aspirated from inside a blood vessel left after
removal of an
embolus or plaque from the blood vessel wall by a therapy catheter does not
decrease the
function of an aspiration catheter aspirating the debris and, therefore, the
debris within the
aspiration catheter is not an occlusion within the aspiration catheter.
As used in this disclosure, the term "occlusion removing structure" refers to
the
intermediate segment and the distal segment of the first component, as these
elements are
disclosed in this disclosure.
As used in this disclosure, the term "drain" refers to the distal end of the
second
component.
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All dimensions specified in this disclosure are by way of example only and are
not
intended to be limiting. Further, the proportions shown in these Figures are
not necessarily
to scale. As will be understood by those with skill in the art with reference
to this
disclosure, the actual dimensions of any device or part of a device disclosed
in this
disclosure will be determined by its intended use.
The' devices of the present invention and their component parts comprise any
suitable material for the intended purpose of the device, as will be
understood by those with
skill in the art with reference to this disclosure. For example, when used as
a medical
drain, the device will usually comprise one or more than one biocompatible
material
capable of being sterilized.
As will be understood by those with skill in the art with reference to this
disclosure,
the device of the present invention can be used for a variety of both surgical
and non-
surgical uses. Examples of surgical uses include biliary tubes and stents,
chest tubes,
decompression catheters, feeding tubes, gastrointestinal decompression
catheters,
gastrostomy tubes, jejunostomy tubes, mediastinal tubes, nasogastric tubes,
nephrostomy
catheters, percutaneous drainage catheters, peritoneal dialysis catheters such
as abscess
drainage catheters, vascular catheters such as venous hemodialysis catheters,
and
ventriculostomy tubes. Further, the device of the present invention can be
used as biliary
and urinary drainage catheters, such as Foley-type bladder catheters placed
after bloody
surgeries, such as prostate resections, where drain tubes tend to occlude with
blood clots.
Additionally, the device of the present invention can be utilized as a sump-
type tube, that
is, a drain possessing an additional lumen used to draw external air into the
patient while
suction is applied to the drain to prevent adhesion of the drain's side
apertures to the
surrounding tissues within the wound or body cavity, thereby preventing fluid
drainage
through the drain.
In one embodiment, the present invention comprises a drainage device. The
drainage device comprises means for drainage and means for removing an
occlusion. .In
each of the embodiments of the drainage device disclosed, the means for
drainage and the
means for removing an occlusion will be identified or will be understood by
those with skill
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in the art with reference to this disclosure. In general, the means for
removing an
occlusion is the occlusion removing structure referred to in this disclosure
(the second
component), and the means for drainage is the drain (the third component).
Referring now to Figure 1 and Figure 2, there are shown, respectively, a top
perspective view of one embodiment of a drainage device according to the
present invention
comprising a drain with an occlusion removing structure (Figure 1); and a
partial, close-up,
lateral perspective view of the drainage device shown in Figure 1 (Figure 2).
As can be
seen, in one embodiment of the present invention, the drainage device 10
comprises two
components, a first component 12 and a second component 14. In a preferred
embodiment,
the drainage device 10 further comprises a third component 16 as seen in
Figure 1 and
Figure 2. The first component 12, the second component 14, and the third
component 16
when present, are all non-integral with respect to each other as they are
configured to join
together in a manner to allow separation of each of the three components from
one another
by the user of the device without cutting through and without destroying the
component.
For example, in one embodiment, the first component 12 can be separated from
the second
component 14 by rotating the first component 12 relative to the second
component 14
around the coaxial long axes of the first component 12 and the second
component 14, and
then by axially sliding the first component 12 proximally relative to the
second component
14. The third component 16 can be separated from the first component 12 by
axially
sliding the third component 16 proximally relative to the first component 12.
The three
components will now be disclosed in greater detail.
The drainage device 10 comprises a proximal end 18 and a distal end 20, and
comprises a drainage device axial length between the proximal end 28 and the
distal end 20.
In a preferred embodiment, the first component 12 extends substantially from
the proximal
end 18 of the drainage device 10 to the distal end 20 of the drainage device
10.
In one embodiment, the first component 12 comprises three integral segments,
which are in the proximal to distal direction, a proximal segment 22, an
intermediate
segment 24 and a distal segment 26. In another embodiment, as will be
understood by
those with skill in the art with reference to this disclosure, (and as shown
in Figure 4), the
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first component 12 comprises the intermediate segment 24 and the distal
segment 26, but
does not comprise the proximal segment 22. In this latter embodiment the
intermediate
segment 24 and the distal segment 26, can also be called a first portion 24
(intermediate
segment 24) and a second portion 26 (distal segment 26) for the sake of
clarity, since this
embodiment does not include a proximal segment 22.
The proximal segment 22 comprises a proximal end 28 and a distal end 30. The
proximal end 28 of the proximal segment 22 comprises an instrument for
creating an
opening in a wall that defines a space or cavity to be drained, such as, for
example, the
chest wall or abdominal wall of a human, and advancing the proximal segment 22
completely through the opening created in the wall. The proximal end 28 of the
proximal
segment 22 can be any suitable instrument, as will be understood by those with
skill in the
art with reference to this disclosure, such as, for example, a rod comprising
a tapered
proximal end. In a preferred embodiment, the proximal segment 22 comprises a
trocar,
such as a surgical trocar comprising a double, triple or quatro cut bullet
point. In a
preferred embodiment, the proximal end 28 of the proximal segment 22 is bent
or curved as
shown along its longitudinal axis.
The distal end 30 of the proximal segment 22 comprises a first connector 32
for
joining the proximal segment 22 to the intermediate segment 24. In a preferred
embodiment, the first connector 32 integrally joins the proximal segment 22 to
the
intermediate segment 24. The first connector 32 can be any suitable connector,
as will be
understood by those with skill in the art with reference to this disclosure.
In a preferred
embodiment, as shown particularly in Figure 2 and Figure 14, the first
connector 32 is a
Christmas-tree type connector. In another preferred embodiment, the proximal
segment 22
comprises stainless steel or another biocompatible surgical grade metal.
Referring again to Figure 1 and Figure 2, and particularly to Figure 2, the
intermediate segment 24 comprises a hollow tube 34 comprising a wall 36 with
an outer
surface 38 and an inner surface 40 defining a central lumen 42, and comprises
a proximal
end 44 and a distal end 46. In a preferred embodiment, the hollow tube 34 is
flexible.
Preferably, the proximal end 44 of the intermediate segment 24 is integrally
joined to the
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first connector 32 of the proximal segment 22, such as, for example, by an
adhesive. In
one embodiment, as shown particularly in Figure 2, the inner surface 40 of the
wall 36 of
the hollow tube 34 at the proximal end 44 of the intermediate segment 24 fits
snugly over
the distal end of the first connector 32 of the proximal segment 22.
The distal end 46 of the intermediate segment 24 comprises a second connector
48
for joining the intermediate segment 24 to the second component 14. In a
preferred
embodiment, the second connector 48 joins the intermediate segment 24 to the
second
component 14 non-integrally. The second connector 48 can be any suitable
connector, as
will be understood by those with skill in the art with reference to this
disclosure. In a
preferred embodiment, as shown particularly in Figure 2, the second connector
48
comprises a female end of a luer-type connector; however, the second connector
48 can
also be the male end of a luer-type connector, or can be any other suitable
connector. In
another preferred embodiment, the intermediate segment 24 comprises a
biocompatible
flexible polymer, such as, for example, polyethylene, or comprises silicone
rubber.
Referring again to Figure 1 and Figure 2, and particularly to Figure 2, the
distal
segment 26 comprises an elongated tubular mesh 50 comprising a proximal end
52, a distal
end 54, an outer surface 56 and an inner surface 58. The proximal end 52 of
the distal
segment 26 is integrally joined to the second connector 48 of the intermediate
segment 24
either mechanically or by chemical means, such as, for example, by an
adhesive, such as,
for example, an epoxy. In a preferred embodiment, the tubular mesh 50
comprises a
material that can be easily cut using a pair of surgical scissors or similar
instrument to a
desired length as appropriate for the intended use, such as, for example, a
cobalt-chromium-nickel-molybdenum-iron alloy specified by ASTM F1058 and ISO
5832-7, stainless steel or a ferrous alloy containing cobalt, chromium,
nickel, molybdenum,
manganese, carbon, and beryllium, such as Elgiloy .
Referring now to Figure 3, there is shown a close-up lateral perspective view
of the
second component of the drainage device shown in Figure 1 and Figure 2. As can
be seen,
in Figure 1, Figure 2 and Figure 3, the second component 14 comprises a hollow
tube 60
comprising a wa1162 with an outer surface 64, an inner surface 66 defining a
central lumen
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68, and comprises a proximal end 70 and a distal end 72. In a preferred
embodiment, the
hollow tube 60 is flexible.
The hollow tube 60 further comprises a plurality of apertures 74 extending
completely through the wall 62 from the outer surface 64 to the inner surface
66, thereby
5 creating a communication between the central lumen 68 and the space outward
from the
outer surface 64. The configuration, number, shape, size and spacing of the
apertures 74
will vary with the intended use. In one embodiment, the hollow tube 60
comprises a
plurality of rows of apertures 74. In another embodiment, the hollow tube 60
comprises
one row of apertures 74. In another embodiment, the hollow tube 60 comprises
two rows
10 of apertures 74. In another embodiment, the hollow tube 60 comprises three
rows of
apertures 74. In another embodiment, the hollow tube 60 comprises four or more
rows of
apertures 74. In one embodiment, the hollow tube 60 comprises between about 4
and about
200 apertures 74. In another embodiment, the hollow tube 60 comprises between
about 10
and about 100 apertures 74. In another embodiment, the hollow tube 60
comprises between
15 about 20 and about 50 apertures 74. In another embodiment, the hollow tube
60 comprises
about 30 apertures 74. In one embodiment, each aperture 74 is round. In
another
embodiment, each aperture 74 is oval. In another embodiment, each aperture 74
is
rectangular. In another embodiment, each aperture 74 is a shape other than
round, oval or
rectangular. In another embodiment,~ at least two apertures 74 are different
shapes. In one
embodiment, each aperture 74 has a maximum length of between about 1 mm and 20
mm.
In another embodiment, each aperture 74 has a maximum length of between about
2 mm
and 10 mm. In another embodiment, each aperture 74 has a maximum length of
between
about 3 mm and 5 mm. In another embodiment, at least two apertures 74 have
different
maximum lengths. In one embodiment, each aperture 74 is spaced apart from the
center of
the next closest aperture 74 of between about 0.5 mm and 50 mm. In another
embodiment,
each aperture 74 is spaced apart from the center of the next closest aperture
74 of between
about 1 mm and 20 mm. In another embodiment, each aperture 74 is spaced apart
from the
center of the next closest aperture 74 of between about 2 mm and 10 mm. In
another
embodiment, each aperture 74 is spaced apart from the center of the next
closest aperture
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74 of between about 3 mm and 5 mm. In another embodiment, the spacing between
the
center of two apertures 74 is different from the spacing between the center of
two other
apertures 74. As shown in Figure 3, by way of example only, in one embodiment,
the
hollow tube 60 comprises two opposing rows of round apertures 74 each about 3
mm in
diameter and spaced about 1 cm apart from the center of the next closest
aperture 74 in the
same row. In a preferred embodiment, the hollow tube 60 also has an opening 76
at the
distal end 72 of the second component 14.
The second component 14 further comprises a third connector 78 at the proximal
end 70, configured to mate non-integrally with the second connector 48 on the
distal end 46
of the intermediate segment 24. The third connector 78 can be any suitable
connector, as
will be understood by those with skill in the art with reference to this
disclosure. In a
preferred embodiment, as shown particularly in Figure 3, the third connector
78 is the male
end of a luer-type connector when the second connector 48 is a female end of
luer-type
connector; however, the third connector 78 can also be the female end of a
luer-type
connector when the second connector 48 is a male end of luer-type connector,
or can be
any other suitable connector, such as, for example, a Christmas-tree type
connector or a
hemostasis Y-connector. In another preferred embodiment, the second component
14
comprises a biocompatible flexible polymer, such as, for example,
polyethylene,
polytetrafluoroethylene and polyamide, or silicone rubber that can be easily
cut using a pair
of surgical scissors or similar instrument to a desired length as appropriate
for the intended
use. In another preferred embodiment, both the second component 14 and the
tubular mesh
50 comprise material that can be easily cut using a pair of surgical scissors
or similar.
instrument using approximately the same force, to a desired length as
appropriate for the
intended use.
Referring now to Figure 4, there is shown a lateral perspective view of an
alternate
embodiment of the drainage device according to the present invention. In this
embodiment,
the first component 12 comprises the intermediate segment 24 and the distal
segment 26,
but does not comprise the proximal segment 22. In this embodiment, the
intermediate
segment 24 and the distal segment 26 can also be called a first portion 24
(intermediate
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17
segment 24) and a second portion 26 (distal segment 26) for the sake of
clarity, since this
embodiment does not include a proximal segment 22.
The first component 12 has a first component axial length extending from the
proximal end 28 of the proximal segment (when the proximal segment 22 is
present) or
from the proximal end of the intermediate segment 24 (when the proximal
segment is not
present) to the distal end 54 of the distal segment 26. In one embodiment, the
first
component axial length is between 60 % and 100 % of the device axial length.
In another
embodiment, the first component axial length is between 70% and 100% of the
device. In
another embodiment, the first component axial length is between 80% and 100%
of the
device axial length. In another embodiment, the first component axial length
is between
90% and 100% of the device axial length. In another embodiment, the first
component
axial length is between 95 % and 100 % of the device axial length. In another
embodiment,
the first component axial length is between 99% and 100% of the device axial
length.
The distal segment 26 of the first component 12 has a distal segment axial
length
extending from the proximal end 52 of the distal segment 26 to the distal end
54 of the
distal segment 26. The second component 14 has a second component axial length
extending from the proximal end 70 of the second component 14 to the distal
end 72 of the
second component 14. In one embodiment, the distal segment axial length is
between 60%
and 100% of the second component axial length. In another embodiment, the
distal
segment axial length is between 70 % and 100 % of the second component axial
length. In
another embodiment, the distal segment axial length is between 80% and 100% of
the
second component axial length. In another embodiment, the distal segment axial
length is
between 90 % and 100 % of the second component axial length. In another
embodiment, the
distal segment axial length is between 95 % and 100 % of the second component
axial
length. In another embodiment, the distal segment axial length is between 99 %
and 100 %
of the second component axial length. For example, in one embodiment, the
distal segment
axial length and the second component axial length are both 50 cm.
Referring now to Figure 5, there is shown a top perspective view of the
optional
third component of the drainage device as shown in Figure 1 and Figure 2. As
can be seen
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in Figure 1, Figure 2 and Figure 5, the drainage device 10 can optionally
comprise the
third component 16. The third component 16 comprises a hollow tube 80
comprising a
wall 82 with an outer surface 84 and an inner surface 86 defining a central
lumen 88, and
comprises a proximal end 90 and a distal end 92. In a preferred embodiment,
the hollow
tube 80 is flexible. The inner surface 86 is configured so that the proximal
end 28 of the
proximal segment 22 fits snugly into the central lumen 88 of the third
component 16,
thereby protecting the user from injury by the proximal end 28 of the proximal
segment 22
during manipulation of the drain before using the proximal end 28 of the
proximal segment
22 to create an opening in a wall defining a space or cavity to be drained.
The wall 82 is
also configured to abut the proximal end of the first connector 32 so as not
to extend over
the first connector 32, because the circumference of the inner surface 86 is
smaller than the
maximum circumference of the first connector 32. In one embodiment, the axial
length of
the third component 16 is approximately equal to the axial length of the
proximal end 28 of
the proximal segment 22. In a preferred embodiment, the axial length of the
third
component 16 exceeds the axial length of the proximal end 28 of the proximal
segment 22
as shown in Figure 1 and Figure 2. In another preferred embodiment, the axial
length of
the third component 16 is at least 10 % longer than the axial length of the
proximal end 28
of the proximal segment 22. In another preferred embodiment, the axial length
of the third
component 16 is at least 20 % longer than the axial length of the proximal end
28 of the
proximal segment 22. In another preferred embodiment, the axial length of the
third
component 16 is at least 30 % longer than the axial length of the proximal end
28 of the
proximal segment 22. In another preferred embodiment, the axial length of the
third
component 16 is between 10 % and 100 % longer than the axial length of the
proximal end
28 of the proximal segment 22. For example, if the proximal end 28 of the
proximal
segment 22 has an axial length of 16 cm, then a third component 16 having an
axial length
of 24 cm would be 50% longer and the axial length of the proximal end 28 of
the proximal
segment 22. The section of the third component 16 extending beyond the
proximal end 28
of the proximal segment 22 can be used to grasp the third component 16 and
remove it
from the remainder of the drainage device 10. In a preferred embodiment, the
third
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19
component 16 comprises a material selected from the group consisting of
polyethylene,
polycarbonate, polytetrafluoroethylene, polyamide and silicone rubber. In a
preferred
embodiment, the third component 16 is flexible.
In another embodiment, the drainage device 10 comprises one or more than one
structure 94 for securing the drainage device 10, such as one or more than one
loop
connected to the intermediate segment 24 or the second component. The
structure 94 is
used to secure the proximal end 18 of the drainage device 10 to a surface,
such as the skin
of a patient when the drainage device 10 is used as a medical drain, or to
another surface,
when the drainage device 10 is used as a non-medical drain.
As will be understood by those with skill in the art with reference to this
disclosure,
the drainage device 10 and its components can be any size suitable for the
intended use. By
way of example only, in one embodiment, both the device 10 (without the third
component
16) comprises a drainage device axial length and the first component axial
length of about
100 cm. The proximal segment 22 of the first component 12 has an axial length
of about
16 cm, of which, the proximal end 28 of the proximal segment 22 has an axial
length of
about 13 cm and the distal end 30 of the proximal segment 22 has an axial
length of about 3
cm. The intermediate segment 24 has an axial length of about 45 cm of which
about 1 cm
of the proximal end 44 of the intermediate segment 24 extends over the first
connection 22.
The distal segment 26 has an axial length of about 48 cm, of which about 3 cm
extend into
the intermediate segment 24. The second component 14 has an axial length of
about 48 cm.
The third component 16 has an axial length of about 15 cm with about 2 cm
extending
proximally beyond the proximal end 28 of the drainage device 10. In one
embodiment, the
inner surface 58 of the distal segment 26 has a diameter of between 1 and 20
mm. In
another embodiment, the outer surface 56 of the distal segment 26 has a
diameter of
between about 2 mm and about 22 mm. In another embodiment, the outer surface
64 of the
distal segment 26 has a diameter of between about 5 mm and about 20 mm. In
another
embodiment, the central lumen 68 of the second component 14 has a diameter of
between
about 2 mm and about 25 mm. In another embodiment, the central lumen 68 of the
second
component 14 has a diameter of between about 4 mm and about 22 mm. In another
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embodiment, the central lumen 68 of the second component 14 has a diameter of
between
about 6 mm and about 15 mm. In another embodiment, the central lumen 68 of the
second
component 14 has a diameter of between about 10 mm and about 15 mm.
The drainage device 10 of the present invention can be constructed according
to
5 standard techniques, as will be understood by those with skill in the art
with reference to
this disclosure.
In another embodiment, the present invention is a kit for removing an
occlusion
from an occluded drain. In this embodiment, the present invention comprises a
drainage
device 10 according to the present invention, and further comprises an
introducer.
10 Referring now to Figures 6 and 7, there are shown a lateral perspective
view of an
introducer (Figure 6); and a bottom perspective view of the introducer shown
in Figure 6
(Figure 7). As can be seen, the introducer 95 comprises an elongate, tubular
structure
comprising a proximal end 96 and a distal end 97. The proximal end 96 is open.
The
distal end 97 can be open as shown, or can be closed. In a preferred
embodiment, the
15 distal end 97 is blunted. The introducer 95 further comprises a maximum
external
circumference 98. In one embodiment, the introducer 95 is scored down its long
axis on at
least one side so that the introducer 95 can be peeled away from its contents.
In a preferred
embodiment, the introducer 95 is flexible.
In another embodiment, the kit for removing an occlusion from an occluded
drain
20 further comprises a replacement first component 12 according to the present
invention
where the replacement first component 12 provided does not comprise the
proximal
segment 22, but consists of the intermediate segment 24 and distal segment 26
only.
Referring now to Figure 8, there is shown a lateral perspective view of an
introducer preloaded with a replacement occlusion removing structure. In a
preferred
embodiment, the replacement occlusion removing structure is a replacement
first
component 12 consisting of the intermediate segment 24 and distal segment 26.
In another
preferred embodiment, the replacement occlusion removing structure is a
replacement
tubular mesh 50 only, as shown in Figure 8. In another preferred embodiment,
the kit
comprises both a drainage device 10 according to the present invention, and an
introducer
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21
95 according to the present invention. In another preferred embodiment, the
kit comprises
a drainage device 10 according to the present invention, and an introducer 95
preloaded
with a replacement occlusion removing structure as shown in Figure 8.
In another embodiment, the present invention comprises a method of removing an
occlusion from an occluded drain.
Referring now to Figure 9 through Figure 15, there are shown partial cutaway,
lateral perspective views of various steps in a method of removing an
occlusion from an
occluded drain according to the present invention. As can be seen, the method
comprises,
first, selecting a space or cavity 100 to be drained. The space or cavity 100
comprises a
wall 102 substantially defining the space or cavity 100 to be drained. In one
embodiment,
the space or cavity 100 is within a human. In one embodiment, the space or
cavity 100 is
within a non-human animal. In another embodiment, the space or cavity 100 is
created by
a surgical procedure. In another embodiment, the space or cavity 100 is
selected from the
group consisting of the abdominal cavity, the bladder, the intestines, the
intracranial cavity,
the mediastinum, the nasal passages, the stomach, the renal pelvis and the
ureter. In
another embodiment, the space or cavity 100 is created during a surgical
procedure on the
back, breast, chest, head, hip or vertebral column.
Next, a drainage device is provided. In one embodiment, the drainage device
provided is a drainage device 10 according to the present invention, where the
drainage
device 10 comprises a first component 12 comprising a proximal segment 22 as
well as an
intermediate segment 24 and a distal segment 26. Reference is now made to
Figure 1
through Figure 8, in addition to Figure 9 through Figure 15. The intermediate
segment 24
and distal segment 26 are an occlusion removing structure. The second
component 14 and,
particularly, the distal end 72 of the second component 14 is a drain.
Then, the distal end 20 of the drainage device 10 is placed within the space
or cavity
100 to be drained through a first opening 104. In one embodiment, placing the
distal end
20 of the drainage device 10 within the space or cavity 100 comprises
introducing the distal
end 20 of the drainage device 10 into the space or cavity through a naturally
existing
opening. In another embodiment, as shown in Figure 10, Figure 11 and Figure
12, the
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22
distal end 20 of the drainage device 10 is placed within the space or cavity
100 through a
man-made opening, such as a surgical incision as indicated in the Figures.
Next, as shown in Figure 11, the proximal end 28 of the proximal segment 22 is
used to create a second opening 106 in the wall 102 of the space or cavity 100
to be
drained, such as, for example, by creating a stab incision from inside the
space or cavity
100 through the wall 102 to outside of the space or cavity 100, and the
proximal segment
22 is advanced completely through the second opening 106 created in the wall
102.
Before or after placing the distal end 20 of the drainage device 10 within the
space
or cavity 100 to be drained, the third component 16, if present, is removed
from the first
component 12 by axially sliding the third component 16 proximally relative to
the first
component 12.
Then, the proximal segment 22 of the first component 12 is separated from the
intermediate segment 24, such as, for example, by cutting the hollow tube 34
proximal to
the second connector 48. This leaves at least part of the second component 14
and at least
part of the occlusion removing structure consisting of the intermediate
segment 24 and
distal segment 26 within the space or cavity 100 as shown in Figure 12.
In one embodiment, as shown in Figure 12, the opening through which the distal
end 20 of the drainage device 10 is placed is then closed, such as, for
example, by suturing
or stapling the first opening 104. In another embodiment, not shown, the
drainage device
10 comprises one or more than one structure 94 for securing the drainage
device 10, such
as one or more than one loop connected to the first component 12. In this
embodiment, the
method further comprises attaching the one or more than one structure 94 to a
surface to
anchor the drainage device 10. In a preferred embodiment, the surface is the
skin of a
patient.
The distal end 72 of the second component 14 of the drainage device 10 is then
allowed to remain in place for an extended period of time in order to drain
drainage
material 108 from the space or cavity 100, such as, for example, blood, bile,
cerebrospinal
fluid, gastrointestinal contents, lymphatic fluid, pus, serosanguinous fluid
and urine, into
the central lumen 68 of the second component 14 (and therefore, into the
tubular mesh 50).
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In one embodiment, the distal end 72 of the second component 14 of the
drainage device 10
is allowed to remain within the space or cavity 100 for between 1 hour and 30
days. In
another embodiment, the distal end 72 of the second component 14 of the
drainage device
is allowed to remain within the space or cavity 100 for between 2 hours and 20
days. In
5 another embodiment, the distal end 72 of the second component 14 of the
drainage device
10 is allowed to remain within the space or cavity 100 for between 3 hours and
10 days. In
another embodiment, the distal end 72 of the second component 14 of the
drainage device
10 is allowed to remain within the space or cavity 100 for between 12 hours
and 10 days.
In another embodiment, the distal end 72 of the second component 14 of the
drainage
10 device 10 is allowed to remain within the space or cavity 100 for between
12 hours and 5
days. In another embodiment, the distal end 72 of the second component 14 of
the drainage
device 10 is allowed to remain within the space or cavity 100 for between 1
day and 7 days.
As can be seen in Figure 13 and Figure 14, after the distal end 72 of the
second
component 14 of the drainage device 10 becomes occluded with drainage material
108, the
occluding drainage material 110 is removed by first, separating the
intermediate segment 24
of the first component 12 from the second component 14, such as, for example,
by rotating
the intermediate segment 24 relative to the second component 14 around the
coaxial long
axes of the intermediate segment 24 and the second component 14, and then by
axially
sliding the intermediate segment 24 proximally relative to the second
component 14.
Axially sliding the intermediate segment 24 proximally relative to the second
component 14
places proximal traction action on the tubular mesh 50 causing it to elongate
axially and
contract perpendicularly to its axis as shown in Figure 14. This contraction
tends to bind
the occluding drainage material 110 within the tubular mesh 50 and keeps the
occluding
drainage material 108 within the tubular mesh 50 as the tubular mesh 50 is
withdrawn
proximally from the second component 14. Once the tubular mesh 50 is withdrawn
with
the occluding drainage material 110, the second component 14 is unoccluded,
that is, the
occluding- drainage material 110 is removed from the drain 14.
In one embodiment, once the space or cavity 100 no longer needs to be drained,
the
drainage device 10 or what remains of the drainage device 10, such as the
second
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component 14, in the space or cavity 100 can be withdrawn from the space or
cavity 100.
If one or more than one structure 94 for securing the drainage device 10 has
been used to
secure the drainage device 10 to a surface, the method comprises detaching the
one or more
than one structure 94 from the surface before withdrawing the drainage device
10 or what
remains fo the drainage device 10 from the space or cavity 100, such as, for
example, by
cutting the sutures anchoring the one or more than one structure 94 from the
skin of a
patient.
In one embodiment, withdrawing the drainage device 10 or what remains of the
drainage device 10, such as the second component 14, from the space or cavity
100
comprises placing proximal traction on the proximal end of the drainage device
10 or what
remains of the drainage device 10, such as the second component 14, thereby
proximally
axially sliding the drainage device 10 or what remains of the drainage device
10, such as
the second component 14, through the second opening 106.
In another embodiment, the method comprises closing the second opening 106
after
withdrawing the drainage device 10 or what remains of the drainage device 10,
such as the
second component 14, such as, for example, by suturing the second opening 106
using
standard surgical techniques.
In another embodiment, the method further comprises attaching the proximal end
44
of the intermediate segment 24 to a suction device 112 after placing the
distal end 20 of the
drainage device 10 in the space or cavity 100. In another embodiment, as shown
in Figure
15, the method comprises attaching the proximal end 70 of the second component
14 to the
suction device 112 after withdrawing the tubular mesh 50.
In another embodiment, the method further comprises cutting the distal end 20
of
the drainage device 10 to shorten the axial length of the drainage device 10
before placing
the drainage device 10 within the space or cavity 100. As will be understood
by those with
skill in the art with reference to this disclosure, cutting the distal end 20
of the drainage
device 10 to shorten the axial length cuts through both the distal end 72 of
the second
component 14 as well as the tubular mesh 50, and leaves at least part of the
distal end 72 of
the second component 14 and tubular mesh 50 intact with the tubular mesh 50
still inside
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the central lumen 68 of the second component 14; therefore, this cutting
action does not
separate the first component 12 from the second component 14 in the context of
this
disclosure. In a preferred embodiment, the tubular mesh 50 comprises a
material that can
be easily cut using a pair of surgical scissors or similar instrument to a
desired length as
5 appropriate for the intended use, such as, for example, a
cobalt-chromium-nickel-molybdenum-iron alloy specified by ASTM F1058 and ISO
5832-7, stainless steel or a ferrous alloy containing cobalt, chromium,
nickel, molybdenum,
manganese, carbon, and beryllium, such as Elgiloy that causes the cut distal
end of the
tubular mesh 50 to retract slightly into the cut distal end 72 of the second
component 14,
10 thereby preventing sharp points of the distal end 54 of the tubular mesh
from damaging the
wall 102 of the space or cavity 100 during use of the drainage device 10.
According to another embodiment of the present invention, there is provided
another method of removing an occlusion from an occluded drain. In this
embodiment, the
first component 12 of the drainage device 10 provided does not comprise the
proximal
15 segment 22, but consists of the intermediate segment 24 and distal segment
26 only, as
shown in Figure 4. In this embodiment, the method does not comprise using the
proximal
end 28 of the proximal segment 22 to create a second opening 106 in the wall
102 of the
space or cavity 100 to be drained. Instead, the method comprises either
creating a second
opening 106 using an instrument separate from the drainage device 10, or
maintaining the
20 proximal end 18 of the drainage device 10 outside the space or cavity 100
while placing the
distal end 20 of the drainage device 10 within the space or cavity 100 through
a preexisting
first opening 104.
According to another embodiment of the present invention, the method
comprises,
additionally, providing a replacement occlusion removing structure where the
replacement
25 occlusion removing structure consists of the intermediate segment 24 and
distal segment 26
of a replacement first component 12. In this embodiment, the method coniprises
inserting
the replacement occlusion removing structure into the second component 14
after removing
an occlusion from the second component 14. In one embodiment, the replacement
occlusion removing structure can be inserted using an introducer 95 according
to the
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present invention, as shown in Figure 6, Figure 7 and Figure 8. In one
embodiment, the
method comprises loading the replacement occlusion removing structure into the
introducer
95 to create a loaded introducer 95 as shown in Figure 8. In another
embodiment, the
method comprises providing an introducer 95 preloaded with the replacement
occlusion
removing structure. The method further comprises inserting the distal end 97
of the
introducer 95 containing the replacement first component 12 or replacement
tubular mesh
50 into the proximal end 70 of the second component 14, and advancing the
introducer 95
until the distal end 97 of the introducer 95 is near the distal end 72 of the
second
component 14, and then, removing the introducer 95 leaving the replacement
first
component 12 or replacement tubular mesh 50 removed. In one embodiment,
removing the
introducer 95 comprises splitting the halves of the introducer 95 along its
scored lines and
peeling the split halves away from the replacement occlusion removing
structure. The
method further comprises allowing the second component 14 with the replacement
occlusion removing structure to remain in place in order to drain drainage
material 108
from the space or cavity 100. The remaining steps of the method are as
disclosed above.
In one embodiment, a second replacement occlusion removing structure is
provided and
inserted into the second component 14 after the first replacement occlusion
removing
structure is removed from the second component 14 to remove an occlusion from
the
second component 14. As will be understood by those with skill in the art with
reference to
this disclosure, additional replacement occlusion removing structures can be
inserted into
the second component 14 sequentially after removal of other occlusions,
thereby
maintaining patentcy of the drain.
Although the present invention has been discussed in considerable detail with
reference to certain preferred embodiments, other embodiments are possible.
Therefore,
the scope of the appended claims should not be limited to the description of
preferred
embodiments contained in this disclosure.
