U.S. patent application number 17/643320 was filed with the patent office on 2022-03-31 for device for collecting a biological sample.
The applicant listed for this patent is Case Western Reserve University. Invention is credited to Rebecca Blice, Amitabh Chak, Sanford Markowitz, Dean Secrest, Dennis Siedlak, Jeffrey Silver Taggart, Joseph Willis.
Application Number | 20220096061 17/643320 |
Document ID | / |
Family ID | |
Filed Date | 2022-03-31 |
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United States Patent
Application |
20220096061 |
Kind Code |
A1 |
Markowitz; Sanford ; et
al. |
March 31, 2022 |
DEVICE FOR COLLECTING A BIOLOGICAL SAMPLE
Abstract
A device for collecting a biological sample in a patient
includes a collection portion having a first axial end portion and
a second axial end portion. The second axial end portion has a
collapsed position and an expanded position. The second axial end
portion moves in an axial direction relative to the first axial end
portion when the second axial end portion moves between the
collapsed position and the expanded position. The second axial end
portion extends axially into the first axial end portion and has a
concave shape when in the collapsed position. The second axial end
portion is convex when in the expanded position.
Inventors: |
Markowitz; Sanford;
(Cleveland, OH) ; Chak; Amitabh; (Cleveland,
OH) ; Willis; Joseph; (Cleveland, OH) ; Silver
Taggart; Jeffrey; (Cleveland, OH) ; Blice;
Rebecca; (Cleveland, OH) ; Secrest; Dean;
(Cleveland, OH) ; Siedlak; Dennis; (Cleveland,
OH) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Case Western Reserve University |
Cleveland |
OH |
US |
|
|
Appl. No.: |
17/643320 |
Filed: |
December 8, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16405634 |
May 7, 2019 |
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17643320 |
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15103638 |
Jun 10, 2016 |
10660621 |
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PCT/US2014/070060 |
Dec 12, 2014 |
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16405634 |
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61915029 |
Dec 12, 2013 |
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International
Class: |
A61B 10/02 20060101
A61B010/02 |
Goverment Interests
GOVERNMENT SUPPORT
[0002] This invention was made with government support under Grant
Nos. P50CA150964, UO1CA152756, U54CA163060 awarded by The National
Institutes of Health. The United States government has certain
rights to the invention.
Claims
1. A device for collecting a biological sample in a patient, the
device comprising a collection portion sufficiently dimensioned to
be swallowed by the patient, the collection portion having a first
axial end portion and a second axial end portion; and the first
axial end portion having a first radius, and the second axial end
portion having a collapsed position having a second radius and an
expanded position having a third radius; and wherein the first
radius is larger than the second radius, and the first radius is
smaller than the third radius.
2. A device for collecting a biological sample as set forth in
claim 1 wherein upon application of a pressurized fluid to the
collection portion, the second axial end portion is configured to
be actuated from the collapsed position having the second radius to
the expanded position having the third radius.
3. A device for collecting a biological sample as set forth in
claim 2, wherein the first axial end portion is rigid such that the
first axial end portion maintains the first radius upon application
of the pressurized fluid to the collection portion.
4. A device for collecting a biological sample as set forth in
claim 2, wherein upon application of a vacuum pressure to the
collection portion, the second axial end portion is configured to
be actuated from the expanded position having the third radius to
the collapsed position having the second radius.
5. A device for collecting a biological sample as set forth in
claim 4, wherein the first axial end portion is rigid such that the
first axial end portion maintains the first radius upon application
of the vacuum pressure to the collection portion.
6. A device for collecting a biological sample as set forth in
claim 2, wherein the second axial end portion has an additional
expanded configuration having a fourth radius, and wherein the
fourth radius is different than the third radius.
7. A device for collecting a biological sample as set forth in
claim 1, wherein the second axial end portion is inverted at least
partially within the first axial end portion in the collapsed
position.
8. A device for collecting a biological sample as set forth in
claim 1 wherein the second axial end portion includes a plurality
of tissue collecting projections.
9. A device for collecting a biological sample as set forth in
claim 8 wherein at least one of the plurality of tissue collecting
projections has a V-shape.
10. A device for collecting a biological sample as set forth in
claim 9 wherein the at least one of the plurality of tissue
collecting projections has first and second sides extending from an
intersection at an angle to each other, the first and second sides
extending toward the first axial end portion from the intersection
when the second axial end portion is in the expanded position.
11. A device for collecting a biological sample as set forth in
claim 8 wherein the plurality of tissue collecting projections
includes at least one circumferentially extending rib.
12. A device for collecting a biological sample as set forth in
claim 8 wherein the plurality of tissue collecting projections
includes at least one radially extending cylindrical
projection.
13. A device for collecting a biological sample as set forth in
claim 8 wherein the plurality of tissue collecting projections
includes at least one bi-directional curved shaped projection.
14. A device for collecting a biological sample as set forth in
claim 1 wherein the first and second axial end portions are
integrally formed as one-piece.
15. A device for collecting a biological sample as set forth in
claim 1 wherein the first and second axial end portions are formed
as separate pieces and connected together.
16. A device for collecting a biological sample as set forth in
claim 1 wherein the first and second axial end portions are
connected by a circumferentially extending hinge.
17. A device for collecting a biological sample as set forth in
claim 1 wherein the second axial end portion is held in the
collapsed position by a cap or cover that falls off, pops off, or
dissolves when the collection portion reaches a collection
site.
18. A method for collecting a biological sample from a collection
site of a lumen of a patient, the method comprising: moving a
collection portion of a device having a first axial end portion,
the first axial end portion having a first radius, and a second
axial end portion into a lumen of a patient with the second axial
end portion in a collapsed position, the second axial end portion
having a second radius in the collapsed position, the first radius
is larger than the second radius; moving the second axial end
portion relative to the first axial end portion from the collapsed
position into an expanded position, the second axial end portion
having a third radius in the expanded position, the third radius is
larger than the first radius; collecting a biological sample with
the second axial end portion in the expanded position; moving the
second axial end portion into the first axial end portion from the
expanded position into the collapsed position; and removing the
device from the lumen of the patient.
19. A method for collecting a biological sample from a lumen as set
forth in claim 18 wherein the step of collecting a biological
sample includes collecting at least one of cells, DNA and/or
RNA.
20. A method for collecting a biological sample from a lumen as set
forth in claim 18 further comprising expanding the second axial end
portion to an additional expanded position, wherein the second
axial end portion has a different geometry in the additional
expanded position than in the expanded position.
21. A method for collecting a biological sample from a lumen as set
forth in claim 18 wherein the step of moving the second axial end
portion from the collapsed position into the expanded position
includes moving the second axial end portion from a concave shape
to a convex shape.
22. A method for collecting a biological sample from a lumen as set
forth in claim 18 wherein the step of moving the second axial end
portion from the expanded position into the collapsed position
includes moving the second axial end portion from a convex shape to
a concave shape.
23. A method for collecting a biological sample from a lumen as set
forth in claim 18 wherein the lumen is an esophagus of the patient,
and wherein the step of moving the collection portion of the device
into the esophagus includes at least one of swallowing the
collection portion and intubating the collection portion.
24. A method for collecting a biological sample from a lumen as set
forth in claim 18 wherein the step of moving the second axial end
portion from the collapsed position into the expanded position
includes applying pressurized air to the second axial end portion
and the step of moving the second axial end portion from the
expanded position into the collapsed position includes applying a
vacuum to the collection portion.
25. A device for placing a collection portion at a site of interest
in a lumen for collecting a sample in a patient, the device
comprising a collection portion provided with a size and shape
sufficiently dimensioned to be swallowed by the patient, the
collection portion having a first axial end portion and a second
axial end portion, wherein the first axial end portion has a fixed
radius, and the second axial end portion is expandable and
collapsible to have a variable radius.
26. A device for placing a collection portion at a site of interest
in a lumen as set forth in claim 25 wherein upon application of a
pressurized fluid to the collection portion, the second axial end
portion is configured to be actuated from a collapsed position
having a first radius to an expanded position having a second
radius.
27. A device for placing a collection portion at a site of interest
in a lumen as set forth in claim 26, wherein upon application of a
vacuum pressure to the collection portion, the second axial end
portion is configured to be actuated from the expanded position
having the second radius to the collapsed position having the first
radius.
28. A device for placing a collection portion at a site of interest
in a lumen as set forth in claim 26, wherein the first radius is
less than the fixed radius of the first axial end portion, and
wherein the second radius is larger than the fixed radius of the
first axial end portion.
29. A device for placing a collection portion at a site of interest
in a lumen as set forth in claim 26, wherein the second axial end
portion is inverted at least partially within the first axial end
portion in the collapsed position.
30. A device for placing a collection portion at a site of interest
in a lumen as set forth in claim 26, wherein the second axial end
portion includes a plurality of tissue collecting projections.
Description
RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
application Ser. No. 16/405,634, filed May 7, 2019, which is a
divisional of U.S. application Ser. No. 15/103,638, filed Jun. 10,
2016, now U.S. Pat. No. 10,660,621, which is a U.S. 371 National
Stage of PCT/US2014/070060, filed Dec. 12, 2014, which claims
priority to and the benefit of Provisional Application No.
61/915,029, filed Dec. 12, 2013, the subject matter of each of
which are incorporated herein by reference in their entireties.
BACKGROUND OF THE INVENTION
[0003] The present invention is directed to a device for collecting
a biological sample, and more specifically, to a device for
collecting a biological sample, such as tissue, cells, protein, RNA
and/or DNA from an esophagus of a patient.
[0004] A known issue collection device includes an expandable
device with longitudinally extending folds. The expandable device
expands radially at a collection site within a body lumen, such as
an esophagus. After the device is expanded, tissue is collected
from the collection site. The expandable device is deflated after
tissue is collected. The folds trap collected tissue when the
device is deflated after collection of tissue. The known tissue
collection device may be inserted through an endoscope to the
collection site or via standard catheter intubation techniques.
SUMMARY OF THE INVENTION
[0005] The present invention relates to a device for collection a
biological a sample in a patient. The device includes a collection
portion having a first axial end portion and a second axial end
portion. The second axial end portion has a collapsed position and
an expanded position. The second axial end portion moves in an
axial direction relative to the first axial end portion when the
second axial end portion moves between the collapsed position and
the expanded position.
[0006] In another aspect of the present invention, a device for
collecting a biological sample in a patient includes a collection
portion having a first axial end portion and a second axial end
portion. The second axial end portion has a collapsed position and
an expanded position. The second axial end portion extends axially
into the first axial end portion and has a concave shape when in
the collapsed position. The second axial end portion is convex when
in the expanded position.
BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The foregoing and other features of the present invention
will become apparent to those skilled in the art to which the
present invention relates upon reading the following description
with reference to the accompanying drawings, in which:
[0008] FIG. 1 is a schematic pictorial view of a biological sample
collection device constructed in accordance with the present
invention;
[0009] FIG. 2 is a schematic pictorial view of the collection
device of FIG. 1 shown in a collapsed position;
[0010] FIG. 3 is a sectional view of the collection device of FIG.
2;
[0011] FIG. 4 is an enlarged plan view of a projection or bristle
of the collection device
[0012] FIG. 5 is a sectional view of the projection taken along the
line 5-5 in FIG. 4;
[0013] FIG. 6 is a schematic pictorial view of a collection device
constructed in accordance with a second embodiment of the present
invention;
[0014] FIG. 7 is a schematic pictorial view of a collection device
constructed in accordance with a third embodiment of the present
invention;
[0015] FIG. 8 is a schematic pictorial view of a collection device
constructed in accordance with a fourth embodiment of the present
invention;
[0016] FIG. 9 is a side view of a projection of the collection
device of FIG. 8;
[0017] FIG. 10 is a schematic pictorial view of a collection device
constructed in accordance with a fifth embodiment of the present
invention;
[0018] FIG. 11 is a schematic pictorial view of a collection device
constructed in accordance with a sixth embodiment of the present
invention;
[0019] FIG. 12 is a schematic sectional view of a collection device
constructed in accordance with a seventh embodiment of the present
invention;
[0020] FIG. 13 is a schematic sectional view of a collection device
constructed in accordance with an eighth embodiment of the present
invention;
[0021] FIG. 14 is a schematic sectional view of the collection
device of FIG. 13 shown in a collapsed position; and
[0022] FIG. 15 is a schematic pictorial view of a collection device
constructed in accordance with a ninth embodiment of the present
invention.
DETAILED OF THE INVENTION
[0023] A collection device 10 for the collecting a biological
sample constructed in accordance with the present invention is
illustrated in FIGS. 1-5. The collection device 10 may used to
collect tissue, cells, protein, RNA and/or DNA from a body lumen,
such as an esophagus of a patient. The tissue, cells, protein, RNA
and/or DNA collected from the esophagus may be used in any one of
the methods disclosed in U.S. patent application Ser. No.
14/109,041, U.S. patent application Ser. No. 13/670,155, U.S.
patent application Ser. No. 13/263,020, U.S. Pat. Nos. 8,642,271,
8,481,707, 8,415,100, 8,221,977, 7,964,353, and 7,485,420, which
are incorporated herein by reference in their entirety.
[0024] The collection device 10 includes a generally hollow
longitudinally extending collection portion 12. The collection
portion 12 has a first or proximal axial end portion 14 and a
second or distal axial end portion 16. The proximal axial end
portion 14 and the distal axial end portion 16 may be made of a
flexible polymer, such as silicone or polyurethane. The distal
axial end portion 16 has a lower durometer than the proximal axial
end portion 14. The distal axial end portion 16 may expand and
contract. The first or proximal axial end portion 14 is relatively
rigid. Therefore, the proximal end portion 14 has a fixed radial
extent. The first axial end portion 14 and the second axial end
portion 16 may be integrally formed as one-piece or may be formed
as separate pieces that are connected together in any desire
manner. Although the proximal end portion 14 is illustrated as
having a cylindrical shape, the proximal end portion may have any
desired shape.
[0025] The proximal axial end portion 14 is connected to a support
member 20, such as a catheter. The support member 20 may be a
tubular member in fluid communication with the interior of the
collection portion 12. The proximal axial end portion 14 conducts
fluid, such as air, from the support member 20 to the distal axial
end portion 16. A proximal end of the support 20 may be connected
to a stopcock and syringe to control the injection of fluid to move
the distal end portion 16 between the collapsed and expanded
positions. The support 20 resists collapsing when a vacuum is
applied to the support member and resists stretching during
withdrawal of the collection device 10 from the collection
site.
[0026] The second or distal end portion 16 of the collection
portion 12 has an expanded or inflated position (FIG. 1) and a
collapsed or deflated position (FIGS. 2-3). The expanded position
shown in FIG. 1 may be one of many expanded positions for the
distal end portion 16. It is contemplated that the distal end
portion 16 may expand more than shown in FIG. 1 so that the distal
end portion obtains a more spherical shape and looks similar to a
hot air balloon, see FIG. 15 for example. The distal end portion 16
has a convex shape, shown in FIG. 1, when in the expanded or
inflated position. The distal end portion 16 may extend radially
outward a greater distance than the proximal end portion 14 when in
the expanded position.
[0027] The distal end portion 16 extends into the first or proximal
axial end portion 14 and has a concave shape, shown in FIGS. 2 and
3, when in the collapsed or deflated position. The distal end
portion 16 may be inverted when in the collapsed position. The
distal end portion 16 extends axially into the interior of the
proximal end portion 14 when in the collapsed or deflated position.
Therefore, the distal end portion 16 moves axially or
longitudinally relative to the proximal end portion 14 when moving
between the deflated and inflated positions. The distal end portion
16 may be biased into the collapsed or deflated position in any
desired manner.
[0028] The proximal end portion 14 has a relatively high durometer
so that the proximal end portion does not collapse when a vacuum is
applied to the proximal end portion through the support 20. The
shape of the proximal end portion 14 does not change when the
distal end portion 16 moves between the deflated and inflated
positions. The proximal end portion 14 does not move radially when
the distal end portion 16 moves between the deflated and inflated
positions.
[0029] The distal end portion 16 of the collection portion 12 may
be connected to the proximal end portion 14 by a circumferentially
extending hinge 30. The hinge 30 may be a fold. The hinge 30 may
extend circumferentially around the collection portion 12. The
hinge 30 defines a distal axial end surface of the collection
portion 12 when the distal end portion 16 is in the deflated or
collapsed position. The distal end portion 16 defines an axial end
surface of the collection portion 12 when the distal end portion is
in the inflated or expanded position.
[0030] The distal end portion 16 has an outer surface 32 for
collecting tissue when the distal portion is in the expanded
position. The outer surface 32 faces radially outwardly when the
distal end portion 16 is in the expanded position and may face
radially inwardly when the distal end portion is in the collapsed
or inverted position. It is contemplated that the outer surface 32
of the distal end portion 16 may have any desired construction for
collecting tissue. The outer surface 32 of the distal end portion
16 may have a plurality of projections or bristles 40 for
collecting tissue. The distal end portion 16 may have any desired
number of projections or bristles 40.
[0031] The projections or bristles 40 may have a V-shape (FIG. 4).
Each projection 40 has a first side 42 and a second side 44
extending from an intersection 48. The first and second sides 42,
44 extend in a generally proximal direction from the intersection
48 when the distal end portion 16 is in the expanded position (FIG.
1). The first and second sides 42, 44 extend in a generally distal
direction when the distal end portion 16 is in the collapsed or
inverted position (FIGS. 2 and 3). The first and second sides 42,
44 define a cup 50 for receiving collected biological samples. The
cup 50 faces in a proximal direction when the distal portion 16 is
in the expanded position and faces in a distal direction when the
distal portion is in the collapsed position.
[0032] The first and second sides 42, 44 may extend at an angle of
approximately 90.degree. relative to each other. It is contemplated
that the first and second sides 42 and 44 may extend at any desired
angle relative to each other. The desired angle may be determined
based on the type of biological sample to be collected.
Alternatively, the projections 40 may be cup shaped or have a
semi-circular shape.
[0033] Each of the projections or bristles 40 has side walls 54 and
56 (FIG. 5) that extend radially outward from the outer surface 32
when the distal portion 16 is in the expanded position. The side
walls 54 and 56 extend from the outer surface 32 to a radially
outer surface 58 of the projection 40. The side walls 54 and 56
taper toward each other as the side walls extend from the outer
surface 32 toward the radially outer surface 58 of the projection
40. It is contemplated that the side walls 54 and 56 may not taper
toward each other.
[0034] The distal end portion 16 may include a plurality of
projections or bristles 60 (FIG. 1) extending from a distal portion
of the distal end portion 16. The projections 60 have the same
general V-shape as the projections 40 and are smaller than the
projections 40. The projections 60 have first and second sides 62
and 64 that have a length smaller than the first and second sides
42, 44 of the projections 40.
[0035] The projections or bristles 40, 60 are arranged in
circumferentially extending rows (FIG. 1). It is contemplated that
each row has six projections 40 or 60. It is contemplated that each
of the rows may have any desired number of projections 40 or 60.
Each of the projections 40, 60 is circumferentially offset from the
projections on an adjacent row. Ribs 66 extend circumferentially
between adjacent projections 40, 60 in each row. The ribs 66 extend
between ends of the sides walls 54, 56 opposite the intersections
48.
[0036] The collection portion 12 is moved to a collection site
within a body lumen, such as an esophagus, with the distal end
portion 16 in the collapsed or deflated position. The collection
portion 12 may be swallowed by a patient. It is also contemplated
that the patient may be intubated with the collection portion 12
attached to a catheter. The distal end portion 16 may be held in
the collapsed or deflated position by the hinge 30 and/or by
applying a vacuum to the collection portion 12 through the support
20. The distal end portion 16 may also be held in the collapsed
position by a cap or cover that falls off, pops off and/or
dissolves when the collection portion 12 reaches the body lumen.
The support member 20 or catheter may have depth markings to
determine the collection site within the patient's anatomy. The
distal end portion 16 is moved from the collapsed position to the
expanded position when the collection portion 12 is at the
collection site. A pressurized fluid, such as air, may be applied
to the distal end portion 16 to cause the distal end portion to
move axially from the collapsed position to the expanded
position.
[0037] The collection portion 12 is moved in the body lumen to
collect a biological sample, such as, tissue, cells, protein, RNA
and/or DNA from the collection site when the distal portion is in
the expanded position. It is contemplated that the collection
portion 12 is only moved in a proximal direction so that the
expanded distal end portion 16 engages the collection site to
collect biological samples. The depth markings on the support
member 20 or catheter may be used as a guide. After the biological
sample is collected, the distal end portion 16 is moved from the
expanded position to the collapsed or inverted position. The distal
end portion 16 may be moved from the expanded position to the
collapsed position by applying a vacuum to the collection portion
12. As the collection portion 12 moves out of the body lumen, the
distal end portion 16 does not engage the body lumen and prevents
the collected biological samples from being contaminated by tissue
from areas along the body lumen different from the collection site.
Once the collection device 10 is removed from the patient, the
biological samples are collected via a wash and/or the collection
portion 12 or the distal end portion 16 may be cut from the support
member 20 and deposited in a biological sample vial.
[0038] A second exemplary embodiment of a collection device
constructed in accordance with the present invention is illustrated
in FIG. 6. The collection device of FIG. 6 is generally similar to
the collection device of FIGS. 1-5. Accordingly, similar numerals
will be used to describe similar components.
[0039] A collection device 110 (FIG. 6) includes a generally hollow
longitudinally extending collection portion 112. The collection
portion 112 has a first or proximal axial end portion 114 and a
second or distal axial end portion 116. The distal axial end
portion 116 may expand and contract. The proximal end portion 114
is relatively rigid. Therefore, the proximal end portion 114 has a
fixed radial extent. The first axial end portion 114 and the second
axial end portion 116 may be integrally formed as one-piece or may
be formed as separate pieces that are connected together in any
desired manner.
[0040] The proximal axial end portion 114 is connected to a support
member 120, such as a catheter. The support member 120 may be a
tubular member in fluid communication with the interior of the
collection portion 112. The proximal end portion 114 conducts
fluid, such as air, from the support member 120 to the distal axial
end portion 116.
[0041] The second or distal end portion 116 of the collection
portion 112 has an expanded or inflated position (FIG. 6) and a
collapsed or deflated position similar to the position shown in
FIGS. 2 and 3. The distal end portion 116 has a convex shape, shown
in FIG. 6, when in the expanded or inflated position. The expanded
position shown in FIG. 6 may be one of many expanded positions for
the distal end portion 116. It is contemplated that the distal end
portion 116 may expand more than shown in FIG. 6 so that the distal
end portion obtains a more spherical shape and looks similar to a
hot air balloon, see FIG. 15 for example.
[0042] The distal end portion 116 extends into the first or
proximal end portion 114 and has a concave shape when in the
collapsed or deflated position. The distal end portion 116 may be
biased into the collapsed or deflated position in any desired
manner. Therefore, the distal end portion 116 moves axially
relative to the proximal end portion 114 when moving between the
deflated and inflated positions. The shape of the proximal end
portion 114 does not change when the distal end portion 116 moves
between the deflated and inflated positions. The proximal end
portion 114 does not move radially when the distal end portion 116
moves between the deflated and inflated positions.
[0043] The distal end portion 116 of the collection portion 112 may
be connected to the proximal end portion 114 by a circumferentially
extending hinge 130. The hinge 130 may be a fold. The hinge 130 may
extend circumferentially around the collection portion 112. The
hinge 130 defines a distal axial end surface of the collection
portion 112 when the distal end portion 116 is in the deflated or
collapsed position. The distal end portion 116 defines an axial end
surface of the collection portion 112 when the distal end portion
is in the inflated or expanded position.
[0044] The distal end portion 116 has an outer surface 132 for
collecting biological samples. The outer surface 132 of the distal
end portion 116 may have a plurality of projections or ribs 140 for
collecting biological samples. The ribs 140 extend
circumferentially around the distal end portion 116 and may extend
generally parallel to each other. Although the outer surface 132 is
shown as having seven projections or ribs 140, it is contemplated
that the outer surface may have any desired number of ribs. The
ribs 140 may extend radially from the outer surface 132 any
distance. It is also contemplated that the ribs 140 may extend
different distances from the outer surface 132.
[0045] A third exemplary embodiment of a collection device
constructed in accordance with the present invention is illustrated
in FIG. 7. The collection device of FIG. 7 is generally similar to
the collection devices of FIGS. 1-6. Accordingly, similar numerals
will be used to describe similar components.
[0046] A collection device 210 (FIG. 7) includes a generally hollow
longitudinally extending collection portion 212. The collection
portion 212 has a first or proximal axial end portion 214 and a
second or distal axial end portion 216. The distal axial end
portion 216 may expand and contract. The proximal end portion 214
is relatively rigid. Therefore, the proximal end portion 214 has a
fixed radial extent. The first axial end portion 214 and the second
axial end portion 216 may be integrally formed as one-piece or may
be formed as separate pieces that are connected together in any
desired manner.
[0047] The proximal end portion 214 has a fixed radial extent. The
proximal axial end portion 214 is connected to a support member
220, such as a catheter. The support member 220 may be a tubular
member in fluid communication with the interior of the collection
portion 212. The proximal axial end portion 214 conducts fluid,
such as air, from the support member 20 to the distal axial end
portion 216.
[0048] The distal end portion 216 of the collection portion 212 has
an expanded or inflated position (FIG. 7) and a collapsed or
deflated position similar to the position shown in FIGS. 2 and 3.
The expanded position shown in FIG. 7 may be one of many expanded
positions for the distal end portion 216. It is contemplated that
the distal end portion 216 may expand more than shown in FIG. 7 so
that the distal end portion obtains a more spherical shape and
looks similar to a hot air balloon, see FIG. 15 for example. The
distal end portion 216 has a convex shape, shown in FIG. 7, when in
the expanded or inflated position.
[0049] The distal end portion 216 extends into the proximal end
portion 214 and has a concave shape when in the collapsed or
deflated position. Therefore, the distal end portion 216 moves
axially relative to the proximal end portion 214 when moving
between the deflated and inflated positions. The distal end portion
216 may be biased into the collapsed or deflated position in any
desired manner. The shape of the proximal end portion 214 does not
change when the distal end portion 216 moves between the deflated
and inflated positions. The proximal end portion 214 does not move
radially when the distal end portion 216 moves between the deflated
and inflated positions.
[0050] The distal end portion 216 of the collection portion 212 may
be connected to the proximal end portion 214 by a circumferentially
extending hinge 230. The hinge 230 may be a fold. The hinge 230 may
extend circumferentially around the collection portion 212. The
hinge 230 defines a distal axial end surface of the collection
portion 212 when the distal end portion 216 is in the deflated or
collapsed position. The distal end portion 216 defines an axial end
surface of the collection portion 212 when the distal end portion
is in the inflated or expanded position.
[0051] The distal end portion 216 has an outer surface 232 for
collecting biological samples. The outer surface 232 of the distal
end portion 216 may have a plurality of projections or bristles 240
for collecting biological samples. The projections 240 have a
generally cylindrical shape. The outer surface 232 may have any
desired number of projections 240. The projections 240 may extend
radially from the outer surface 232 any distance. It is also
contemplated that the projections 240 may extend different
distances from the outer surface 232. The projections 240 may have
any desired diameters and may have different diameters.
[0052] A fourth exemplary embodiment of a collection device
constructed in accordance with the present invention is illustrated
in FIGS. 8 and 9. The collection device of FIGS. 8 and 9 is
generally similar to the collection devices of FIGS. 1-7.
Accordingly, similar numerals will be used to describe similar
components.
[0053] A collection device 310 (FIGS. 8-9) includes a generally
hollow longitudinally extending tissue collection portion 312. The
collection portion 312 has a first or proximal axial end portion
314 and a second or distal axial end portion 316. The distal axial
end portion 316 may expand and contract. The proximal end portion
314 is relatively rigid. Therefore, the proximal end portion 314
has a fixed radial extent. The first axial end portion 314 and the
second axial end portion 316 may be integrally formed as one-piece
or may be formed as separate pieces that are connected together in
any desired manner.
[0054] The proximal end portion 314 has a fixed radial extent. The
proximal axial end portion 314 is connected to a support member
320, such as a catheter. The support member 320 may be a tubular
member in fluid communication with the interior of the collection
portion 312. The proximal axial end portion 314 conducts fluid from
the support member 320 to the distal axial end portion 316.
[0055] The distal end portion 316 of the collection portion 312 has
an expanded or inflated position (FIG. 8) and a collapsed or
deflated position similar to the position shown in FIGS. 2 and 3.
The expanded position shown in FIG. 8 may be one of many expanded
positions for the distal end portion 316. It is contemplated that
the distal end portion 316 may expand more than shown in FIG. 8 so
that the distal end portion obtains a more spherical shape and
looks similar to a hot air balloon, see FIG. 15 for example. The
distal end portion 316 has a convex shape, shown in FIG. 8, when in
the expanded or inflated position.
[0056] The distal end portion 316 extends into the proximal end
portion 314 and has a concave shape when in the collapsed or
deflated position. Therefore, the distal end portion 316 moves
axially relative to the proximal end portion 314 when moving
between the deflated and inflated positions. The distal end portion
316 may be biased into the collapsed or deflated position in any
desired manner. The shape of the proximal end portion 314 does not
change when the distal end portion 316 moves between the deflated
and inflated positions. The proximal end portion 314 does not move
radially when the distal end portion 316 moves between the deflated
and inflated positions.
[0057] The distal end portion 316 of the collection portion 312 may
be connected to the proximal end portion 314 by a circumferentially
extending hinge 330. The hinge 330 may be a fold. The hinge 330 may
extend circumferentially around the collection portion 312. The
hinge 330 defines a distal axial end surface of the collection
portion 312 when the distal end portion 316 is in the deflated or
collapsed position. The distal end portion 316 defines an axial end
surface of the collection portion 312 when the distal end portion
is in the inflated or expanded position.
[0058] The distal end portion 316 has an outer surface 332 for
collecting biological samples. The outer surface 332 is generally
cylindrical. The outer surface 332 has an axially extending surface
334 and an axial end surface 336. The axially extending surface 334
of the outer surface 332 may have a plurality of projections or
bristles 340 for collecting tissue. It is contemplated that the
axial end surface 336 may also include projections 340.
[0059] Each of the projections 340 has a support portion 342 (FIG.
9). The support portion 342 may have a bi-directional curve shape
or S-shape extending radially outward from the outer surface 332. A
bi-directional curve shaped or S-shaped portion 344 having a
cross-section larger than the support portion 342 extends from the
support portion, as shown in FIG. 9. The outer surface 332 may have
any desired number of projections 340. The projections 340 may
extend radially from the outer surface 332 any distance. It is also
contemplated that the projections 340 may extend different
distances from the outer surface 332.
[0060] A fifth exemplary embodiment of a collection device
constructed in accordance with the present invention is illustrated
in FIG. 10. The collection device of FIG. 10 is generally similar
to the collection devices of FIGS. 1-9. Accordingly, similar
numerals will be used to describe similar components.
[0061] A collection device 410 (FIG. 10) includes a generally
hollow longitudinally extending collection portion 412. The
collection portion 412 has a first or proximal axial end portion
414 and a second or distal axial end portion 416. The distal axial
end portion 416 may expand and contract. The proximal end portion
414 is relatively rigid. Therefore, the proximal end portion 414
has a fixed radial extent. The first axial end portion 414 and the
second axial end portion 416 may be integrally formed as one-piece
or may be formed as separate pieces that are connected together in
any desired manner.
[0062] The proximal end portion 414 has a fixed radial extent. The
proximal axial end portion 414 is connected to a support member
420, such as a catheter. The support member 420 may be a tubular
member in fluid communication with the interior of the collection
portion 412. The proximal end portion 414 conducts fluid, such as
air, from the support member 420 to the distal axial end portion
416.
[0063] The distal end portion 416 of the collection portion 412 has
an expanded or inflated position (FIG. 10) and a collapsed or
deflated position similar to the position shown in FIGS. 2 and 3.
The expanded position shown in FIG. 10 may be one of many expanded
positions for the distal end portion 416. It is contemplated that
the distal end portion 416 may expand more than shown in FIG. 10 so
that the distal end portion obtains a more spherical shape and
looks similar to a hot air balloon, see FIG. 15 for example. The
distal end portion 16 has a convex shape, shown in FIG. 10, when in
the expanded or inflated position.
[0064] The distal end portion 416 extends into the proximal end
portion and has a concave shape when in the collapsed or deflated
position. Therefore, the distal end portion 416 moves axially
relative to the proximal end portion 414 when moving between the
deflated and inflated positions. The distal end portion 416 may be
biased into the collapsed or deflated position in any desired
manner. The shape of the proximal end portion 414 does not change
when the distal end portion 416 moves between the deflated and
inflated positions. The proximal end portion 414 does not move
radially when the distal end portion 416 moves between the deflated
and inflated positions.
[0065] The distal end portion 416 of the collection portion 412 may
be connected to the proximal end portion 414 by a circumferentially
extending hinge 430. The hinge 430 may be a fold. The hinge 430 may
extend circumferentially around the collection portion 412. The
hinge 430 defines a distal axial end surface of the collection
portion 412 when the distal end portion 416 is in the deflated or
collapsed position. The distal end portion 416 defines an axial end
surface of the collection portion 412 when the distal end portion
is in the inflated or expanded position.
[0066] The distal end portion 416 has an outer surface 432 for
collecting biological samples. The outer surface 432 of the distal
end portion 416 may have a plurality of projections or bristles 440
for collecting biological samples. The projections or bristles 440
may have a V-shape and be generally similar to the V-shaped
projections 40 described in connection with the embodiment
illustrated in FIGS. 1-5. Each projection 440 has a side 442 and a
second side 444 extending in a generally proximal direction from an
intersection 448 when the distal end portion 416 is in the expanded
position. Therefore, the first and second sides 442, 444 define a
proximally facing cup 450 for receiving collected tissue. The first
and second sides 442, 444 extend at an angle to each other. The
first and second sides 442, 444 may extend at an angle of
approximately 90.degree. relative to each other. It is contemplated
that the first and second sides 442 and 444 may extend at any
desired angle relative to each other. The desired angle may be
determined based on the type of biological sample to be
collected.
[0067] The distal end portion 416 may include a plurality of
projections or bristles 460 extending from a distal portion of the
distal end portion 416. The projections 460 have the same general
V-shape as the projections 440. The projections 460 are smaller
than the projections 440 and are located distally to the
projections 440 when the distal end portion 416 is in the expanded
position.
[0068] A sixth exemplary embodiment of a collection device
constructed in accordance with the present invention is illustrated
in FIG. 11. The collection device of FIG. 10 is generally similar
to the collection devices of FIGS. 1-10. Accordingly, similar
numerals will be used to describe similar components.
[0069] A collection device 510 (FIG. 11) includes a generally
hollow longitudinally extending collection portion 512. The
collection portion 512 has a first or proximal axial end portion
514 and a second or distal axial end portion 516. The distal axial
end portion 516 may expand and contract. The proximal end portion
514 is relatively rigid. Therefore, the proximal end portion 514
has a fixed radial extent. The first axial end portion 514 and the
second axial end portion 516 may be integrally formed as one-piece
or may be formed as separate pieces that are connected together in
any desired manner.
[0070] The proximal end portion 514 has a fixed radial extent. The
proximal axial end portion 514 is connected to a support member
520, such as a catheter. The support member 520 may be a tubular
member in fluid communication with the interior of the collection
portion 512. The proximal end portion 514 conducts fluid from the
support member 520 to the distal axial end portion 516.
[0071] The distal end portion 516 of the collection portion 512 has
an expanded or inflated position (FIG. 11) and a collapsed or
deflated position similar to the position shown in FIGS. 2 and 3.
The expanded position shown in FIG. 11 may be one of many expanded
positions for the distal end portion 516. It is contemplated that
the distal end portion 516 may expand more than shown in FIG. 11 so
that the distal end portion obtains a more spherical shape and
looks similar to a hot air balloon, see FIG. 15 for example. The
distal end portion 16 has a convex shape, shown in FIG. 11, when in
the expanded or inflated position.
[0072] The distal end portion 516 extends into the proximal end
portion 514 and has a concave shape when in the collapsed or
deflated position. Therefore, the distal end portion 516 moves
axially relative to the proximal end portion 514 when moving
between the deflated and inflated positions. The distal end portion
516 may be biased into the collapsed or deflated position in any
desired manner. The shape of the proximal end portion 514 does not
change when the distal end portion 516 moves between the deflated
and inflated positions. The proximal end portion 514 does not move
radially when the distal end portion 516 moves between the deflated
and inflated positions.
[0073] The distal end portion 516 of the collection portion 512 may
be connected to the proximal end portion 514 by a circumferentially
extending hinge 530. The hinge 530 may be a fold. The hinge 530 may
extend circumferentially around the collection portion 512. The
hinge 530 defines a distal axial end surface of the collection
portion 512 when the distal end portion 516 is in the deflated or
collapsed position. The distal end portion 516 defines an axial end
surface of the collection portion 512 when the distal end portion
is in the inflated or expanded position.
[0074] The distal end portion 516 has an outer surface 532 for
collecting biological samples. The outer surface 532 of the distal
end portion 516 may have a plurality of projections or bristles 540
for collecting biological samples. The projections or bristles 540
may have an X-shape. The distal end portion 516 may include a
plurality of projections or bristles 560 extending from a distal
portion of the distal end portion 516. The projections 560 have the
same general X-shape as the projections 540. However, the
projections 560 are smaller than the projections 540.
[0075] A seventh exemplary embodiment of a collection device
constructed in accordance with the present invention is illustrated
in FIG. 12. The collection device of FIG. 12 is generally similar
to the collection devices of FIGS. 1-11. Accordingly, similar
numerals will be used to describe similar components.
[0076] A collection device 610 (FIG. 12) includes a generally
hollow longitudinally extending collection portion 612. The
collection portion 612 has a first or proximal axial end portion
614 and a second or distal axial end portion 616. The distal axial
end portion 616 may expand and contract. The proximal end portion
614 is relatively rigid. Therefore, the proximal end portion 614
has a fixed radial extent.
[0077] The proximal axial end portion 614 is connected to a support
member, such as a catheter. The support member may be a tubular
member in fluid communication with the interior of the collection
portion 612. The proximal end portion 614 conducts fluid from the
support member to the distal end portion 616.
[0078] The distal end portion 616 has a first axial end portion 622
connected to the proximal axial end portion 614. The first end
portion 622 may be connected to the proximal end portion 614 in any
desired manner, such as by using an adhesive. The first axial end
portion 622 engages a shoulder 624 on the proximal axial end
portion 614. Therefore, the collection portion 612 has a smooth
outer surface.
[0079] The distal end portion 616 of the collection portion 612 has
an expanded or inflated position (FIG. 12) and a collapsed or
deflated position similar to the position shown in FIGS. 2 and 3.
The expanded position shown in FIG. 12 may be one of many expanded
positions for the distal end portion 616. It is contemplated that
the distal end portion 616 may expand more than shown in FIG. 12 so
that the distal end portion obtains a more spherical shape and
looks similar to a hot air balloon, see FIG. 15 for example. The
distal end portion 16 has a convex shape, shown in FIG. 12, when in
the expanded or inflated position.
[0080] The distal end portion 616 extends into the proximal end
portion 614 and has a concave shape when in the collapsed or
deflated position. Therefore, the distal end portion 616 moves
axially relative to the proximal end portion 614 when moving
between the deflated and inflated positions. The distal end portion
616 may be biased into the collapsed or deflated position in any
desired manner. The shape of the proximal end portion 614 does not
change when the distal end portion 616 moves between the deflated
and inflated positions. The proximal end portion 614 does not move
radially when the distal end portion 616 moves between the deflated
and inflated positions.
[0081] The distal end portion 616 of the collection portion 612 may
be connected to the proximal end portion 614 at a circumferentially
extending hinge 630. The hinge 630 may extend circumferentially
around the collection portion 612. The hinge 630 defines a distal
axial end surface of the collection portion 612 when the distal end
portion 616 is in the deflated or collapsed position. The distal
end portion 616 defines an axial end surface of the collection
portion 612 when the distal end portion is in the inflated or
expanded position.
[0082] The distal end portion 616 has an outer surface 632 for
collecting biological samples. It is contemplated that the outer
surface 632 of the distal end portion 616 may have any desired
construction for collecting biological samples. The outer surface
632 of the distal end portion 616 may have a plurality of
projections or bristles for collecting biological samples. The
projections or bristles may have any desired shape, such as the
shapes shown in FIGS. 1-11.
[0083] An eighth exemplary embodiment of a collection device
constructed in accordance with the present invention is illustrated
in FIGS. 13-14. The collection device of FIGS. 13-14 is generally
similar to the collection devices of FIGS. 1-12. Accordingly,
similar numerals will be used to describe similar components.
[0084] A collection device 710 (FIG. 11) includes a generally
hollow longitudinally extending collection portion 712. The
collection portion 712 has a first or proximal axial end portion
714 and a second or distal axial end portion 716. The distal axial
end portion 716 may expand and contract. The proximal end portion
714 is relatively rigid. Therefore, the proximal end portion 714
has a fixed radial extent. The first axial end portion 714 and the
second axial end portion 716 may be integrally formed as one-piece
or may be formed as separate pieces that are connected together in
any desired manner.
[0085] The proximal end portion 714 has a fixed radial extent. The
proximal axial end portion 714 is connected to a support member
720. The support member 720 may be a tubular member in fluid
communication with the interior of the collection portion 712. The
proximal end portion 714 conducts fluid from the support member 720
to the distal end portion 716.
[0086] The distal end portion 716 of the collection portion 712 has
an expanded or inflated position (FIG. 13) and a collapsed or
deflated position (FIG. 14). The expanded position shown in FIG. 13
may be one of many expanded positions for the distal end portion
716. It is contemplated that the distal end portion 716 may expand
more than shown in FIG. 13 so that the distal end portion obtains a
more spherical shape and looks similar to a hot air balloon, see
FIG. 15 for example. The distal end portion 716 has a convex shape,
shown in FIG. 13, when in the expanded or inflated position.
[0087] The distal end portion 716 extends into the proximal end
portion 714 and has a concave shape when in the collapsed or
deflated position, as shown in FIG. 14. The distal end portion 716
only moves axially relative to the proximal end portion 714 when
moving between the deflated and inflated positions. The distal end
portion 716 may be biased into the collapsed or deflated position
in any desired manner. The shape of the proximal end portion 714
does not change when the distal end portion 716 moves between the
deflated and inflated positions. The proximal end portion 714 does
not move radially when the distal end portion 716 moves between the
deflated and inflated positions.
[0088] The distal end portion 716 of the collection portion 712 may
be connected to the proximal end portion 714 by a circumferentially
extending hinge 730. The hinge 730 may be a fold. The hinge 730 may
extend circumferentially around the collection portion 712. The
hinge 730 defines a distal axial end surface of the collection
portion 712 when the distal end portion 716 is in the deflated or
collapsed position. The distal end portion 716 defines an axial end
surface of the collection portion 712 when the distal end portion
is in the inflated or expanded position.
[0089] The distal end portion 716 has an outer surface 732 for
collecting biological samples. It is contemplated that the outer
surface 732 of the distal end portion 716 may have any desired
construction for collecting biological samples. The outer surface
732 of the distal end portion 716 may have a plurality of
projections or bristles 740 for collecting biological samples. The
outer surface 732 may have any desired number of projections
740.
[0090] A ninth exemplary embodiment of a collection device
constructed in accordance with the present invention is illustrated
in FIG. 15. The collection device of FIG. 15 is generally similar
to the collection device of FIGS. 1-14. Accordingly, similar
numerals will be used to describe similar components.
[0091] A collection device 810 (FIG. 15) includes a generally
hollow longitudinally extending collection portion 812. The
collection portion 812 has a first or proximal axial end portion
814 and a second or distal axial end portion 816. The distal axial
end portion 816 may expand and contract. The proximal end portion
814 is relatively rigid. Therefore, the proximal end portion 814
has a fixed radial extent. The first axial end portion 814 and the
second axial end portion 816 may be integrally formed as one-piece
or may be formed as separate pieces that are connected together in
any desired manner.
[0092] The proximal axial end portion 814 is connected to a support
member 820, such as a catheter. The support member 820 may be a
tubular member in fluid communication with the interior of the
collection portion 812. The proximal end portion 814 conducts
fluid, such as air, from the support member 820 to the distal axial
end portion 816.
[0093] The second or distal end portion 816 of the collection
portion 812 has an expanded or inflated position (FIG. 15) and a
collapsed or deflated position similar to the position shown in
FIGS. 2 and 3. The distal end portion 816 has a convex shape, shown
in FIG. 15, when in the expanded or inflated position. The expanded
position shown in FIG. 15 may be one of many expanded positions for
the distal end portion 816. It is contemplated that the distal end
portion 816 may expand less than shown in FIG. 15 so that the
distal end portion obtains a more oblong shape and looks similar to
the distal end portion 16 shown in FIG. 1.
[0094] The distal end portion 816 extends into the first or
proximal end portion 814 and has a concave shape when in the
collapsed or deflated position. The distal end portion 816 may be
biased into the collapsed or deflated position in any desired
manner. Therefore, the distal end portion 816 moves axially
relative to the proximal end portion 814 when moving between the
deflated and inflated positions. The shape of the proximal end
portion 814 does not change when the distal end portion 816 moves
between the deflated and inflated positions. The proximal end
portion 814 does not move radially when the distal end portion 816
moves between the deflated and inflated positions.
[0095] The distal end portion 816 of the collection portion 812 may
be connected to the proximal end portion 814 by a circumferentially
extending hinge 830. The hinge 830 may be a fold. The hinge 830 may
extend circumferentially around the collection portion 812. The
hinge 830 defines a distal axial end surface of the collection
portion 812 when the distal end portion 816 is in the deflated or
collapsed position. The distal end portion 816 defines an axial end
surface of the collection portion 812 when the distal end portion
is in the inflated or expanded position. The distal end portion 816
has an outer surface 832 for collecting biological samples. The
outer surface 832 of the distal end portion 816 may have a textured
surface or include a plurality of projections or ribs for
collecting biological samples.
[0096] Each of the collection portions of the described collection
devices is moved to a collection site within a body lumen, such as
an esophagus, with the distal end portion in the collapsed or
deflated position. The collection portion may be swallowed by a
patient. The distal end portion may be held in the collapsed or
deflated position by the hinge and/or by applying a vacuum to the
collection portion through the support. The distal end portion may
also be held in the collapsed position by a cap or cover that falls
off, pops off and/or dissolves when the collection portion reaches
the collection site. The distal end portion is moved from the
collapsed position to the expanded position when the collection
portion is at the collection site. The collection portion is moved
in the body lumen to collect biological samples, such as, tissue,
cells, protein, RNA and/or DNA from the collection site when the
distal portion is in the expanded position. After the biological
sample is collected, the distal end portion is moved from the
expanded position to the collapsed position. As the collection
portion moves out of the body lumen, the distal end portion does
not engage the body lumen and prevents the collected biological
samples from being contaminated by tissue from areas along the body
lumen different from the collection site.
[0097] The collection devices described above may be formed as
one-piece or formed as separate pieces that are connected together.
Also, it is contemplated that the projections or bristles may have
any desired shape. Accordingly, the tissue collection devices may
have at least one V-shaped projection and/or at least one
circumferentially extending rib and/or at least one cylindrical
projection and/or at least one bi-directional curved shaped
projection and/or at least one X-shaped projection. It is also
contemplated that each of the collection devices may have
circumferentially extending ribs extending between adjacent
projections.
[0098] From the above description of the invention, those skilled
in the art will perceive improvements, changes and modifications.
Such improvements, changes and modifications are intended to be
covered by the appended claims.
* * * * *