Note: Descriptions are shown in the official language in which they were submitted.
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METHOD AND DEVICE FOR REMOVING AN OCCLUSION
CROSS-REFERENCE TO RELATED APPLICATION
The present Application claims the benefit of United States Provisional Patent
Application 60/63,597 titled "Cleaner for Tubular Structure," filed December
23, 2004, and
claims priority from International Patent Application No. PCT/USOS/00508,
filed January 7,
2005, the contents of which are incorporated in this disclosure by reference
in their entirety.
BACKGROUND
There are a large variety of tubular structures having a central axial lumen
used in
medical applications, and in non-medical commercial and industrial
applications. Examples
of tubular structures used in medical applications include catheters, drains
and tubes. In
many such applications, the tubular structure is prone to collecting debris
within the central
lumen of the tubular structure that occludes the tubular structure, causing a
decrease or
cessation of function of the tubular structure, and necessitating that the
occlusion be removed
or that the tubular structure be replaced.
In medical applications in particular, replacing a tubular structure can be
very costly,
and can put a patient at increased risk of infection. Therefore, it is often
preferable to
remove the occlusion from within the central lumen of the tubular structure.
In some
applications, the occlusion can be removed by flushing the central lumen of
the tubular
structure with a liquid, thereby moving the occlusion distally. In many
applications,
however, flushing the occlusion distally is not acceptable, such as, for
example, when using a
tubular structure to drain a cavity or space within the human body.
Therefore, there is a need for a method of removing an occlusion from within
the
central lumen of a tubular structure, such as a tubular structure used in a
medical application,
that does not comprise flushing the occlusion distally.
SUMMARY
According to one embodiment of the present invention, there is provided a
device for
removing an occlusion from within the central lumen of a tubular structure. In
one
embodiment the device comprises a proximal end, a distal end and an
intermediate segment
between the proximal end and 'the distal end; and comprises an occlusion
removing structure
having a low profile configuration and having a high profile configuration,
the occlusion
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removing structure comprising a proximal end, a distal end and an intermediate
segment
between the proximal end and the distal end, and comprising an outer diameter.
In a preferred embodiment, the occlusion removing structure comprises an
extension
of the intermediate segment; and the occlusion removing structure further
comprises one or
more than one foldable disc mounted transversely on the extension, and
converting the device
from the low profile configuration to the high profile configuration comprises
unfolding the
one or more than one disc; where the device further comprises a sheath
comprising a
proximal end, a distal end, and a central lumen; where the sheath surrounds
the intermediate
segment of the occlusion removing structure, and where the sheath is axially
movable with
respect to the occlusion removing structure. Tn one embodiment, the one or
more than one
foldable disc is a plurality of discs. In another embodiment, at least one of
the plurality of
discs has a diameter different from another of the plurality of discs. In one
embodiment, the
one or more than one foldable disc is at least three discs, and the distance
between two
adjacent discs is different from the distance between two different adjacent
discs. In one
embodiment, each disc comprises silicone.
In a preferred embodiment, the device further comprises a sheath comprising a
proximal end, a distal end, and a central lumen; where the sheath is axially
movable with
respect to the occlusion removing structure; where the distal end of the
occlusion removing
structure comprises a self-expanding portion; where the sheath functions to
compress the self
expanding portion within the central lumen of the sheath; and where converting
the device
from the low profile configuration to the high profile configuration comprises
relieving the
compression on the self-expanding portion. In one embodiment, the distal end
of the sheath
further comprises a flaring distal collar configured to permit the self
expanding portion of the
distal end of the device to be retracted into the central lumen of the sheath.
In one embodiment, the device, further comprises a removable tab surrounding
the
intermediate segment of the occlusion removing structure, immediately distal
to the proximal
end of the device, where the tab prevents extrusion of the distal end of the
occlusion
removing structure from the distal end of the sheath. In another embodiment,
the sheath
comprises a proximal collar configured to prevent the proximal end of the
occlusion
removing structure from entering the central Iumen of the sheath. In one
embodiment, the
occlusion removing structure further comprises a mechanism for applying axial
force to the
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distal end of the occlusion removing structure. In another embodiment, the
device further
comprises an enclosure bag comprising a proximal end, a distal end and an
intermediate
segment, where the intermediate segment of the enclosure bag comprises a tube
of material
capable of being reversibly compressed and extended axially.
In another preferred embodiment, the distal end of the occlusion removing
structure
comprises an inflatable balloon, and converting the device from the Iow
profile configuration
to the high profile configuration comprises inflating the balloon; and the
device further
comprises an enclosure bag comprising a proximal end, a distal end and an
intermediate
segment, where the intermediate segment of the enclosure bag comprises a tube
of material
capable of being reversibly compressed and extended axially. In another
preferred
embodinnent, the device has a long axis, the distal end of the occlusion
removing structure
comprises an expandable wire basket, and converting the device from the low
profile
configuration to the high profile configuration comprises activating a
mechanism, thereby
transmitting axial force to contract the wire basket in a distal to proximal
direction, and
thereby expanding the wire basket in a direction perpendicular to the axis of
the device; and
where the device further comprises an enclosure bag comprising a proximal end,
a distal end
and an intermediate segment, where the intermediate segment of the enclosure
bag comprises
a tube of material capable of being reversibly compressed and extended
axially.
In one embodiment, the intermediate segment of the enclosure bag comprises a
substantially transparent material. In another embodiment, the proximal end of
the enclosure
bag comprises a proximal end piece comprising an axial lumen having a diameter
greater than
the outer diameter of the occlusion removing structure. In another embodiment,
the distal
end of the enclosure bag comprises a distal end piece comprising an axial
lumen having a
diameter greater than the outer diameter of the occlusion removing structure.
In another
embodiment, the distal end of the enclosure bag comprises a connector for
mating with the
proximal end of the tubular structure with an occlusion. In a preferred
embodiment, the
connector is a "Christmas Tree" type connector or is a Luer-lock type
connector. In one
embodiment, the enclosure bag further comprises a removable cover.
In one embodiment, the proximal end of the device further comprises a
connector. In
another embodiment, the occlusion removing structure comprises an extension of
the
intermediate segment, and the extension comprises a blunted tip at the distal
end of the
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occlusion removing structure.
According to one embodiment of the present invention, there is provided a
method for
removing an occlusion from a tubular structure, where the tubular structure
comprises a
proximal end, a distal end, an intermediate segment and a central lumen within
the
intermediate segment, and where the occlusion is within the central lumen. The
method
comprises a) providing means for removing an occlusion from within the central
lumen of a
tubular structure, where the means for removing an occlusion comprises a
proximal end and a
distal end, and comprises an occlusion removing structure having a low profile
configuration
and having a high profile configuration; b) inserting the distal end of the
means for removing
an occlusion into the proximal end of the tubular structure in the low profile
configuration;
c) advancing the means for removing an occlusion through the central lumen of
the tubular
structure until the distal end of the means for removing an occlusion is at
least partly distal to
the occluding material; d) converting the occlusion removing structure into
the high profile
configuration; and e) withdrawing the means for removing an occlusion from the
tubular
structure while the occlusion removing structure is in the high profile
configuration, thereby
removing some or all of the occluding material from the tubular structure. In
one
embodiment, the means for removing an occlusion comprises one or more than one
foldable
disc, and converting the occlusion removing structure into the high profile
configuration
comprises unfolding the one or more than one foldable disc. In another
embodiment, the
means for removing an occlusion comprises a self expanding portion, and where
converting
the occlusion removing structure into the high profile configuration comprises
relieving
compressive force on the self expanding portion. In another embodiment, the
means for
removing an occlusion comprises an enclosure bag; and withdrawing the means
for removing
an occlusion causes the occluding material to deposit within the enclosure
bag. In one
embodiment, the means for removing an occlusion comprises an inflatable
balloon;
converting the occlusion removing structure into the high profile
configuration comprises
inflating the inflatable balloon; the means for removing an occlusion
comprises an enclosure
bag; and withdrawing the means for removing an occlusion causes the occluding
material to
deposit within the enclosure bag. In one embodiment, the means for removing an
occlusion
comprises a wire basket; converting the occlusion removing structure into the
high profile
configuration comprises activating a mechanism to transmit axial force to
contract a wire
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basket in a distal to proximal direction thereby expanding the wire basket;
the means for
removing an occlusion comprises an enclosure bag; and withdrawing the means
for removing
an occlusion causes the occluding material to deposit within the enclosure
bag. In a preferred
embodiment, the method comprises repeating steps b) through e). In another
embodiment,
5 the means for removing an occlusion is a first means for removing an
occlusion, and the
method further comprises performing the steps b) through e) with a second
means for
removing an occlusion, where the first means for removing an occlusion and the
second
means for removing an occlusion comprise different mechanisms for converting
the occlusion
removing structure from the low profile configuration to the high profile
configuration. In
another embodiment, the tubular structure comprises a connector on the
proximal end, and
the method further comprises connecting the means for removing an occlusion to
the
connector.
According to one embodiment of the present invention, there is provided a
method for
removinb.an occlusion from a tubular structure, where the tubular structure
comprises a
proximal end, a distal end, an intermediate segment and a central lumen within
the
intermediate segment, and where the occlusion is within the central lumen. The
method
comprises a) providing a device according to the present invention; b)
inserting the distal end
of the device into the proximal end of the tubular structure in the low
profile configuration; c)
advancing the device through the central lumen of the tubular structure until
the distal end of
the device is at least partly distal to the occluding material; d) converting
the occlusion
removing structure into the high profile configuration; and e) withdrawing the
device from
the tubular structure while the occlusion removing structure is in the high
profile
configuration, thereby removing the occluding material from the tubular
structure. In one
embodiment, the device comprises an enclosure bag, and withdrawing the device
causes the
occluding material to deposit within the enclosure bag. In another embodiment,
the device
further comprises a removable tab; and the method further comprises removing
the tab from
the intermediate segment, thereby permitting the distal end of the occlusion
removing
structure to extrude through the distal end of the sheath. In ane embodiment,
withdrawing
the device causes the occluding material to deposit within the enclosure bag.
In another
embodiment, the method comprises repeating steps b) through e). In one
embodiment, the
device is a first device, and the method further comprises performing the
steps b) through e)
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with a second device, where the first device and the second device comprise
different
mechanisms for converting the occlusion removing structure from the low
profile
configuration to the high profile configuration. In another embodiment, the
tubular structure
comprises a connector on the proximal end, and the method further comprises
connecting the
device to the connector. In another embodiment, the method further comprises
unconnecting
the connector from the device after removing the occluding material.
FIGURES
These and other features, aspects and advantages of the present invention will
become
better understood with regard to the following description, appended claims,
and
accompanying figures where:
Figure 1 is a lateral perspective view of one embodiment of a device for
removing an
occlusion from within the central lumen of a tubular structure according to
the present
invention including the optional enclosure bag;
Figure 2 is a lateral perspective view of the occlusion removing structure of
the device
shown in Figure 1;
Figure 3 is an enlarged cutaway lateral perspective view of the distal end of
the device
shown in Figure 1;
Figure 4 is an enlarged lateral perspective view of the distal end of the
occlusion
removing structure of the device shown in Figure 1, Figure 2 and Figure 3;
Figure 5 is a lateral perspective view of an enclosure bag of the device
according to
the present invention;
Figure 6 is a lateral perspective view of another embodiment of a device for
removing
an occlusion from within the central lumen of a tubular structure according to
the present
invention;
Figure 7 is a partial lateral perspective view of the device shown in Figure 6
with the
distal end of the occlusion removing structure extruded from the distal end of
the sheath;
Figure 8 is an enlarged cutaway partial lateral perspective view of the device
shown in
Figure 6 including the optional enclosure bag;
Figure 9 is a lateral perspective view of another embodiment of a device for
removing
an occlusion from within the central lumen of a tubular structure according to
the present
invention in the low profile configuration;
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Figure 10 is a close-up lateral perspective view of the distal end of the
device shown
in Figure 9 in the high profile configuration;
Figure 11 is a lateral perspective view of another embodiment of a device for
removing an occlusion from within the central lumen of a tubular structure
according to the
present invention in the low profile configuration;
Figure 12 is a close-up lateral perspective view of the distal end of the
device shown
in Figure 9 in the high profile configuration; and
Figure 13 through Figure 16 show partial, cutaway, lateral perspective views
of
various steps in a method for removing an occlusion from an occluded tubular
structure
according to the present invention.
DESCRIPTION
According to one embodiment of the present invention, there is provided a
device for
removing an occlusion from within the central lumen of a tubular structure.
The device
comprises an occlusion removing structure having a low profile configuration
and having a
high profile configuration. The device is particularly useful for removing an
occlusion from
within the central lumen of a tubular structure without having to apply
proximal suction, or
having to, move the occlusion distally. According to another embodiment of the
present
invention, there is provided a method for removing an occlusion from within
the central
lumen of a tubular structure. In one embodiment, the method comprises
providing a device
according to the present invention. The method further comprises inserting the
device while
in the low profile configuration into the tubular structure with an occlusion.
Then, the device
is converted to its high profile configuration, and the device is withdrawn
from the tubular
structure, thereby removing the occlusion from the tubular structure. The
device and method
of the present invention will now be disclosed 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 fr steps.
As used in this disclosure, the term "tubular structure" should be understood
as any
elongated structure having an open proximal end, a distal end and a
continuously hollow
. 30 central lumen extending from the open proximal end to the distal end. The
distal end of the
tubular structure can be either open or closed, as will be understood by those
with skill in the
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art with reference to this disclosure. The term "tubular structure"
encompasses catheters,
drains, tubes such as gastrostomy and feeding tubes, and any other similar
devices.
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 material
within the
central lumen of a tubular structure, which either partially or completely
decreases the
function of the tubular structure. 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 on or within 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 .
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.
Although the present invention is disclosed specifically with reference to its
applications in the medical field, the invention can also be used in any other
suitable
applicati;~n, including other non-medical commercial or industrial
applications, as will be
understood by those with skill in the art with reference to this disclosure.
The device of the present invention, and its various parts, comprises any
material
suitable for the purposes disclosed in this disclosure. When used in medical
applications, the
device will generally comprise one or more than one biocompatible material. In
one
embodiment, the device comprises one or more than one material that can be
sterilized. In a
preferred embodiment, the device consists of one or more than one
biocompatible material.
In another embodiment, the device comprises one or more than one material that
can be
discarded without creating a significant biohazard. In a preferred embodiment,
the device
consists of one or more than one material that can be discarded without
creating a significant
biohazard.
The device of the present invention, and its various parts, are manufactured
according
to techniques well known to those with skill in the art, as will be understood
by those with
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skill in the art with reference to this disclosure.
According to one embodiment of the present invention, there is provided a
device for
removing an occlusion from within the central lumen of a tubular structure.
The device
comprises an occlusion removing structure having a low profile configuration
and having a
high profile configuration.
Referring now to Figure 1 through Figure 4, there are shown a lateral
perspective
view of one embodiment of a device for removing an occlusion from v~ithin the
central lumen
of a tubular structure according to the present invention including the
optional enclosure bag
(Figure 1); a lateral perspective view of the occlusion removing structure of
the device shown
in Figure 1 (Figure 2); an enlarged cutaway lateral perspective view of the
distal end of the
device shown in Figure 1 (Figure 3); and an enlarged lateral perspective view
of the distal
end of the occlusion removing structure of the device shown in Figure 1,
Figure 2 and Figure
3 (Figure 4). As can be seen, the device 10 comprises a proximal end 12, a
distal end 14 and
an intermediate segment 16 between the proximal end 12 and the distal end 14.
As shown in
Figure 1 through Figure 4, the device 10 comprises an occlusion removing
structure 18, and
as shown in Figure 1 and Figure 3, the device 10 further comprises a sheath
20.
Referring again to Figure 2, Figure 3 and Figure 4, the occlusion removing
structure
18 comprises a proximal end 22, a distal end 24 and an intermediate segment 26
between the
proximal end 22 and the distal end 24, and comprises an outer diameter. In a
preferred
embodiment, as shown in Figure 1 and Figure 2, the proximal end 22 of the
occlusion
removing'structure 18 comprises a mechanism for applying axial force 27 to the
distal end 24
of the occlusion removing structure 18, such as an enlarged end as shown. In
one
embodiment, the proximal end of the device 10 further comprises a connector,
such as, for
example, a screw type connector or a Luer-lock type connector.
Referring again to Figure 2, the intermediate segment 26 of the occlusion
removing
structure 18 is a mechanism for transmitting axial force from the proximal end
22 of the
occlusion removing structure 18 to the distal end 24 of the occlusion removing
structure 18.
In one embodiment, as shown, the intermediate segment 26 is a rod. In another
embodiment,
the intermediate segment 26 is a tube. In another embodiment, the intermediate
segment 26
is a pusher wire. In a preferred embodiment, the intermediate segment 26 is
significantly
flexible when ordinary force is applied to the proximal end by an operator
during use of the
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device 10 in a method according to the present invention, in order to permit
the device 10 to
bend around curves in the tubular structure, such as, for example, around
curves of as much
as 45 ° . 'The intermediate segment 26 has a longitudinal axis, and has
a diameter
perpendicular to the axis. In one embodiment, the axis is between about 10 cm
and about
S 200 cm. In another embodiment, the axis is between about 20 cm and about 100
cm. In
another embodiment, the axis is between about 30 cm and about SO cm. In one
embodiment,
the diameter of the intermediate segment 26 is between about 0.2 mm and 4 mm.
In another
embodiment, the diameter of the intermediate segment 26 is between about 0.4
mm and 1
mm. In another embodiment, the diameter of the intermediate segment 26 is
between about
10 O.S mm and 0.6 mm.
As shown in Figure 2, Figure 3 and particularly Figure 4, the distal end 24 of
the
occlusion removing structure 18 of the device 10 comprises a.n extension 28 of
the
intermediate segment 26. In a preferred embodiment, the extension 28 comprises
a blunted
tip 30 at the distal end 24 of the occlusion removing structure 18. In one
embodiment, the tip
1S 30 comprises a material selected from the group consisting of plastic,
rubber and silicone. In
a preferred embodiment, the tip 30 comprises a low friction material, such as,
for example,
polytetrafluoroethylene, that reduces friction between the tip 30 and the
surface of the central
lumen of the tubular structure with the occlusion.
The occlusion removing structure 18 of the device 10 further comprises one or
more
than one foldable disc 32 mounted transversely on the extension 28. In one
embodiment, the
occlusion removing structure 18 further comprises one disc 32 mounted
transversely on the
extension 28. In a preferred embodiment, the occlusion removing structure 18
further
comprises a plurality of discs 32 mounted transversely on the extension 28. In
one
embodiment, the occlusion removing structure 18 further comprises two discs 32
mounted
2S transversely on the extension 28. In another embodiment, the occlusion
removing structure
18 further comprises three discs 32 mounted transversely on the extension 28.
In another
embodiment, the occlusion removing structure 18 further comprises four or more
than four
discs 32 mounted transversely on the extension 28.
Each disc 30 has a diameter and a thickness. In one embodiment, the diameter
of
each disc is between O.S mm and 20 mm. In another embodiment, the diameter of
each disc
is between '1 mm and 10 mm. In another embodiment, the diameter of each disc
is between 2
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mm and 4 mm. In one embodiment, the thickness of each disc is between 0.2 mm
and 2 mm.
In another embodiment, the thickness of each disc is between 0.3 mm and 1 mm.
In another
embodiment, the diameter of each disc is between 0.4 mm and 0.6 mm.
In one embodiment, the occlusion removing structure 18 comprises a plurality
of discs
32 mounted transversely on the extension 28, and at least one of the plurality
of discs 32 has
a diameter different from another of the plurality of discs 32. In one
embodiment, the
occlusion removing structure 18 comprises at least three discs 32 mounted
transversely on the
extension 28, and each disc 32 is equally spaced apart from the adjacent disc
32. In one
embodiment, the occlusion removing structure 18 comprises at least three discs
32 mounted
transversely on the extension 28, and the distance between two adjacent discs
32 is different
from the distance between two different adjacent discs 32.
In one embodiment, the occlusion removing structure 18 comprises a plurality
of discs
32 mounted' transversely on the extension 28, and each disc 32 is spaced apart
from the
adjacent disc 32 by between 0.5 mm and 10 mm. In another embodiment, the
occlusion
removing structure 18 comprises a plurality of discs 32 mounted transversely
on the
extension 28, and each disc 32 is spaced apart from the adjacent disc 32 by
between 1 mm
and 5 mm. In another embodiment, the occlusion removing structure 18 comprises
a
plurality of discs 32 mounted transversely on the extension 28, and each disc
32 is spaced
apart from the adjacent disc 32 by between 2 mm and 4 mm.
In one embodiment, each disc 32 comprises a material selected from the group
consisting of plastic and rubber. In another embodiment, each disc 32
comprises a
thermoplastic elastomer, such as, for example, C-Flex~ (available from Cole-
Palmer~,
Vernon Hills, IL US). In a preferred embodiment, each disc comprises silicone.
R°ferring again to Figure 1 and Figure 3, the device 10 further
comprises a sheath 20.
The sheath 20 has a proximal end 34, a distal end 36, and a central lumen 38.
The sheath 20
surrounds the intermediate segment 26 of the occlusion removing structure 18,
and surrounds
at least part of the distal end 24 before the device 10 is used, and during
some steps of the
method according to the present invention. The sheath is axially movable with
respect to the
occlusion removing structure. The sheath 20 functions to fold the one or more
than one disc
32 against the extension 28, thereby converting the device 10 from a high
profile
configuration to a low profile configuration. In one embodiment, the sheath 20
comprises a
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proximal collar 40 configured to prevent the proximal end 22 of the occlusion
removing
structure 18 from entering the central lumen 38 of the sheath 20. In a
preferred embodiment,
the sheath 20 is significantly flexible when ordinary force is applied to the
proximal end by
an operator during use of the device 10 in a method according to the present
invention, in
S order to permit the device 10 to bend around curves in the tubular
structure. In one
embodiment, he sheath comprises a braided plastic sheath that resists kinking
when bent. In
another embodiment, the sheath 20 comprises a plastic or wire coil, however,
the sheath can
comprise any suitable material, as will be understood by those with skill in
the art with
reference to this disclosure.
In a preferred embodiment, the device 10 further comprises an enclosure bag.
Referring now to Figure S, there is shown a lateral perspective view of an
enclosure bag of
the device 10 according to the present invention. As can be seen, the
enclosure bag 42
comprises a proximal end 44, a distal end 46 and an intermediate segment 48.
The
intermediate segment 48 of the enclosure bag 42 comprises a tube SO of
material capable of
IS being reversibly compressed and extended axially when ordinary force is
applied to the
proximal end 44 of the enclosure bag 42 by an operator during use of the
device 10 in a
method according to the present invention. The enclosure bag 42 is configured
to protect the
portions of the device 10 inside the enclosure bag 42 as the device 10 is
introduced into a
tubular structure to remove an occlusion. The tube SO has an inner surface.
When being
used to remove an occlusion from a tubular structure functioning as a medical
device, the
inner surface of the tube 50 of the intermediate segment 48 is preferably
sterile. Further, the
intermediate segment 48 of the enclosure bag 42 functions to contain occluding
material as
the occluding material is removed from the tubular structure, as will be
better understood
with reference to the method of the present invention disclosed further below.
In a preferred
2S embodiment, the intermediate segment 48 of the enclosure bag 42 comprises a
substantially
transpar~~at material such as, for example, a substantially transparent
plastic that is
sufficiently transparent to allow an operator to view the portion of the
device 10 that is inside
the intermediate segment 48.
In one embodiment, the proximal end 44 of the enclosure bag 42 comprises a
proximal end piece S2. If present, the proximal end piece S2 comprises an
axial lumen S4
having a diameter greater than the outer diameter of the occlusion removing
structure 18 with
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the sheath 20, if present, where the diameter of the lumen 54 of the proximal
end piece 52 is
sufficient to allow the occlusion removing structure 18, and sheath 20 if
present, to translate
axially through the proximal end piece 52 and into the intermediate segment
48. In one
embodiment, the proximal end piece 52 further comprises a connector, not
shown.
In another embodiment, the distal end 46 of the enclosure bag 42 further
comprises a
distal end piece 58. If present, the distal end piece 58 also comprises an
axial lumen 60
having a diameter greater than the outer diameter of the occlusion removing
structure 18 and,
the sheath 20 if present, where the diameter of the lumen 56 of the distal end
piece 58 is
sufficient to allow the occlusion removing structure 18 and, the sheath 20 if
present, to
translate axially from the intermediate segment 48 through the distal end
piece 58 with the
occluding material when the occlusion removing structure 18 is in the high
profile
configuration. In a preferred embodiment, the distal end piece 58 further
comprises a
connector 62 for mating with the proximal end of the tubular structure with an
occlusion. In
one embodiment, the connector 62 can be a screw type connector or a Luer-lock
type
connector. In a particularly preferred embodiment, the connector 62 is a
"Christmas Tree"
type connector. The connector 62 can, however, be any other type of connector
suitable for
mating with the proximal end of the tubular structure with an occlusion, as
will be understood
by those with skill in the art with reference to this disclosure.
In another preferred embodiment, the enclosure bag 42 further comprises a
removable
cover 64 (shown in Figure 8) mating with the distal end piece 52. When
present, the cover
maintains the sterility of the distal end piece 52 prior to use.
Referring now to Figure 6 through Figure 8, there are shown a lateral
perspective
view of another embodiment of a device for removing an occlusion from within
the central
lumen of a tubular structure according to the present invention (Figure 6); a
partial lateral
perspective view of the device shown in Figure 6 with the distal end of the
occlusion
removing structure extruded from the distal end of the sheath (Figure 7); and
an enlarged
cutaway partial lateral perspective view of the device shown in Figure 6
including the
optional enclosure bag (Figure 8). As can be seen, the device 66 comprises
elements
corresponding to the elements disclosed and referenced with respect to the
device 10. In the
embodiment of the device 66, however, the distal end 24 of the occlusion
removing structure
18 comprises a self-expanding portion 68 rather than one or more than one
foldable disc 32.
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The self expanding portion 68 is readily compressible by a compressive force,
and also self-
expands, that is to say, expands upon merely relieving the compressive force
without either
infusing a liquid or gas, or by unfolding, or by using a mechanism that
untwists the structure.
In this embodiment, the sheath 20 functions to compress the self-expanding
portiom 68 within
the central lumen 38 of the sheath 20, that is, the wall of the sheath applies
a compressive
force to the self-expanding portion 68, thereby converting the device 66 from
a high profile
configuration to a low profile configuration, rather than by folding the one
or more than one
foldable disc 32 as with the embodiment of the device 10. In a preferred
embodiment, the
self expanding portion 68 is a sponge, as shown, but the self-expanding
portion 68 can be a
mass of foam or of radially expanding fibers, or can be another suitable self
expanding
structure, as will be understood by those with skill in the art with reference
to this disclosure.
In the embodiment of the device 66, the distal end 36 of the sheath 20 further
comprises a flaring distal collar 70, as shown. The distal collar 36 is
configured to permit
the self-expanding portion 68 of the distal end 36 of the device 66 to be
retracted into the
central lumen 38 of the sheath 20, as well be understood more clearly with
reference to the
method of the present invention.
In another preferred embodiment, the device 66 further comprises a removable
tab 72
surrounding the intermediate segment 26 of the occlusion removing structure
18, immediately
distal to vhe proximal end 14 of the device 66. The tab 72 prevents extrusion
of the distal end
24 of the occlusion removing structure 18 from the distal end 36 of the sheath
20. The tab 72
comprises a reversibly tearable material, such as paper, or is perforated
along a line parallel
to the long axis of the intermediate segment 26 of the occlusion removing
structure 18, so
that the tab 72 can be removed from the intermediate segment 26, thereby
permitting the
distal end 24 of the occlusion removing structure 18 to extrude through the
distal collar 70 of
the sheath 20.
Referring now to Figure 9 and Figure 10, there are shown a lateral perspective
view
of another embodiment of a device for removing an occlusion from within the
central lumen
of a tubular structure according to the present invention in the low profile
configuration
(Figure 9); and a close-up lateral perspective view of the distal end of the
device shown in
Figure 9 in the high profile configuration (Figure 10). As can be seen, the
device 74
comprises elements corresponding to the elements disclosed and referenced with
respect to
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the device 10 and the device 66. In the embodiment of the device 74, however,
the distal end
24 of the occlusion removing structure 18 comprises an inflatable balloon 76
rather than one
or more than one foldable disc 32, or a self expanding portion 68. Further, in
the
embodiment of the device 74, the intermediate segment 26 of the occlusion
removing
5 structure 18 comprises a central inflation lumen that can be connected to an
inflation
mechanism for inflating the inflatable balloon 76. In this embodiment, the
device 74 is
converted from a low profile configuration to a high profile configuration by
infusing a liquid
or a gas through the central inflation lumen thereby inflating the inflatable
balloon 76, rather
than by folding the one or more than one folding disc 32 as with the
embodiment of the
10 device 10, or by relieving the compressive force on the self-expanding
portion 68 as with the
embodiment of the device 66. The device 74 further comprises an enclosure bag
42 as
disclosed in this disclosure. The device does not require a sheath 20 to
function.
In one embodiment, the inflatable balloon 76 has an axial length of between 1
mm and
30 mm. In another embodiment, the inflatable balloon 76 has an axial length of
between 2
15 mm and 20 mm. In another embodiment, the inflatable balloon 76 has an axial
length of
between 3 mm and IO mm. In one embodiment, the inflatable balloon 76 has a
maximum
diameter of expansion of between 1 mm and 30 mm. In one, the inflatable
balloon 76
comprises a material selected from the group consisting of latex, a plastic,
silicone rubber,
and a thermoplastic elastomer.
In a preferred embodiment, the intermediate segment 26 of the occlusion
removing
structure ~T8 of the device 74 comprises a braided plastic sheath that resists
kinking when
bent. Referring now to Figure 11 and Figure 12, there are shown a lateral
perspective view
of another embodiment of a device for removing an occlusion from within the
central lumen
of a tubular structure according to the present invention in the low profile
configuration
(Figure 11); and a close-up lateral perspective view of the distal end of the
device shown in
Figure 11 in the high profile configuration (Figure 12). As can be seen, the
device 78
comprises elements corresponding to the elements disclosed and referenced with
respect to
the device 10, the device 66 and the device 74. In the embodiment of the
device 72,
however, the distal end 24 of the occlusion removing structure 18 comprises an
expandable
wire basket 80 rather than one or more than one foldable disc 32, or a self-
expanding portion
68 or an inflatable balloon 76. Further, in the embodiment of the device 78,
the proximal
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end 22 comprises a mechanism 82 for expanding the expandable wire basket 80
and the
intermediate segment 26 of the occlusion removing structure 18 comprises a
wire within the
intermediate segment 26 connecting the mechanism 82 with the wire basket 76.
In this
embodiment, the device 78 is converted from a low profile configuration to a
high profile
configuration by activating the mechanism 82, thereby transmitting axial for
ce to contract the
wire basket 76 in a distal to proximal direction, and thereby expanding the
wire basket 76 in
a direction perpendicular to the axis of the device 78, rather than by folding
the one or more
than one foldable disc 32 as with the embodiment of the device 10, or by
relieving the
compressive force on a self expanding portion 68 as with the embodiment of the
device 66,
or by inflating the inflatable balloon 76 as with the embodiment of the device
74. The device
78 further comprises an enclosure bag 42 as disclosed in this disclosure. The
device does not
require a sheath 20 to function.
According to another embodiment of the present invention, there is provided a
method
for removing an occlusion from within the central lumen of a tubular
structure. The steps
shown are not intended to be limiting nor are they intended to indicate that
each step depicted
. is essential to the method, but instead are exemplary steps only. In one
embodiment, the
method comprises providing a device according to the present invention.
Referring now to Figure 13 through Figure 16, there are shown partial,
cutaway,
lateral perspective views of various steps in a method for removing
an.occlusion comprising
occluding material from an occluded tubular structure according to the present
invention. As
can be seen in Figure 13, a tubular structure 100 is in position, such as
within a space or
cavity within a human 102, and the central lumen 104 of the tubular structure
100 has either
partly or completely occluded with occluding material 106. The tubular
structure comprises
a proximal end 108, a distal end 110, and intermediate segment 112. In a
preferred
embodiment, the tubular structure 100 comprises a connector 114 on the
proximal end 108 as
shown.
In one embodiment, the method comprises, first, providing means for removing
an
occlusion from within the central lumen of a tubular structure. The means for
removing an
occlusion comprises a proximal end and a distal end, and comprises an
occlusion removing
structure having a low profile configuration and having a high profile
configuration. Next,
the distal end of the means for removing an occlusion is inserted into the
proximal end of the
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tubular structure in the low profile configuration. Then, the means for
removing an
occlusion is advanced through the central lumen of the tubular structure until
the distal end of
the means for removing an occlusion is at least partly distal to the occluding
material. Next,
the occlusion removing structure is converted into the high profile
configuration. In one
embodiment, converting the occlusion removing structure into the high profile
configuration
comprises unfolding one or more than one foldable disc, or comprises relieving
compressive
force on the self-expanding portion, or comprises inflating an inflatable
balloon, or comprises
activating a mechanism to transmit axial force to contract a wire basket in a
distal to
proximal direction thereby expanding the wire basket. Then, the means for
removing an
occlusion is withdrawn from the tubular structure while the occlusion removing
structure is in
the high profile configuration, thereby removing some or all of the occluding
material from
the tubular structure. In one embodiment, the means for removing an occlusion
comprises an
enclosure bag, and withdrawing the means for removing an occlusion causes the
occluding
material to deposit within the enclosure bag. In one embodiment, the method
comprises
repeating these steps. In another embodiment, the means for removing an
occlusion is a first
means for removing an occlusion, and method further comprises performing the
same steps
with a second means for removing an occlusion, where the first means for
removing an
occlusion and the second means for removing an occlusion comprise different
mechanisms
,.
for converting the occlusion removing structure from the low profile
configuration to the high
profile configuration, such as, for example, where the first means for
removing an occlusion
is a device 10 and the second means for removing an occlusion is a device 66.
In another embodiment, the method comprises, first, providing a device
according to
the present,invention. In a preferred embodiment, the device is a device 10,
or a device 66,
or a device 74 or a device 78. The device 10, 66, 70, 74 comprises a proximal
end 12, a
distal end 14 and an intermediate segment 16 between the proximal end 12 and
the distal end
14. The device 10~ 66, 70, 74 further comprises an occlusion removing
structure 1~ having a
low profile configuration and having a high profile configuration. In a
preferred
embodiment, the device 10, 66 provided comprises a sheath 20. In another
preferred
embodiment, the device 10, 66, 70, 74 comprises an enclosure bag 42. The
device 10, 66,
70, 74, the sheath 20 and the enclosure bag 42 are according to the present
invention, as
disclosed in this disclosure. If present, the cover 64 of the enclosure bag 42
is removed after
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providing the device 10, 66, 70, 74.
Referring now to Figure 14 through Figure 16, there are shown some steps of
the
method using the device 10. As can be seen, the distal end 14 of the device 10
is inserted
into the proximal end 108 of the tubular structure 100 in the low profile
configuration. Then,
the device 10 is advanced through the central lumen 104 of the tubular
structure 100 until the
distal end 14 of the device 10 is at least partly distal to the occluding
material 106. Next, the
occlusion, removing structure 18 is converted into the high profile
configuration by advancing
the foldable discs 32 distally relative to the distal end 36 of the sheath,
thereby unfolding the
discs 32. Then, the device 10 is withdrawn from the tubular structure 100
while the
occlusion removing structure 18 in the high profile configuration, thereby
removing the
occluding material 106 from the tubular structure 100.
As will be understood by those with skill in the art with reference to this
disclosure
the method depicted in Figure 13 through Figure 16 can also be accomplished
using the
device 66, where converting the occlusion removing structure 18 of the device
66 into the
high profile configuration comprises relieving compressive force on the self
expanding
portion 68 by advancing the self expanding portion 68 distally relative to the
distal end 36 of
the sheath. The remaining steps of this embodiment of the method correspond to
the steps
disclosed in reference to the device 10.
As will be understood by those with skill in the art with reference to this
disclosure
the method depicted in Figure 13 through Figure 16 can also be accomplished
using the
device 74, where converting the occlusion removing structure 18 of the device
74 into the
high profile configuration comprises inflating the inflatable balloon 76. The
remaining steps
of this embodiment of the method correspond to the steps disclosed in
reference to the device
10.
As will be understood by those with skill in the art with reference to this
disclosure
the method depicted in Figure 13 through Figure 16 can also be accomplished
using the
device 78, where converting the occlusion removing structure 18 of the device
78 into the
high profile configuration comprises activating the mechanism 82, thereby
transmitting axial
force to contract the wire basket 76 in a distal to proximal direction, and
thereby expanding
the wire basket 76 in a direction perpendicular to the axis of the device 78.
The remaining
steps of this embodiment of the method correspond to the steps disclosed in
reference to the
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device 10.
In one embodiment of the method, the device 10, 66, 74, 78 comprises an
enclosure
bag 42, and inserting the distal end 14 of the device 10 into the proximal end
108 of the
tubular structure 100 comprises compressing the tube 50 axially, and
withdrawing the device
10, 66, 74, 78 causes the occluding material to deposit within the enclosure
bag 42.
In another embodiment of the method, the proximal end 108 of the tubular
structure
100 comprises a connector 114, and the method comprises connecting the
connector 114 to
the device 10, 66, 74, 78 through a connector on the proximal end 14 of the
device 10, 66,
74, 78, or through a connector 56 on the enclosure bag 42. In one embodiment,
the method
further comprises unconnecting the connector 114 from the device 10, 66, 74,
78 after
removing the occluding material 106.
In another embodiment of the method, the device 10, 66 comprises a sheath 20
and
further comprises a removable tab 72, and the method further comprises
removing the tab 72
from the intermediate segment 26, thereby permitting the distal end 24 of the
occlusion
removing structure 18 to extrude through the distal end 36 of the sheath.
In another embodiment, the method comprises repeating one or more than one of
.ahese steps.
In another embodiment, the device is a first device, and the method further
comprises
repeating the steps with a second device, where the occlusion removing
structure of the first
device and the occlusion removing structure of the second device are converted
from the low
profile configuration to the high profile configuration by two different steps
selected from the
group consisting of unfolding one or more than one foldable disc, relieving
compressive force
on a self expanding portion, inflating an inflatable balloon, and activating a
mechanism to
transmit axial force to contract a wire basket in a distal to proximal
direction thereby
expanding the wire basket.
Altr~ough 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.
