Note: Descriptions are shown in the official language in which they were submitted.
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TISSUE COLLECTION LID FOR A SPECIMEN CUP
PRIORITY
[0001] This application claims the benefit under 35 U.S.C. 11'9(e) of U.S.
Provisional Application No. 60/580,499, filed June 17, 2004, which is
expressly
incorporated by reference as if fully set forth herein.
BACKGROUND
[0002] Sample and specimen cups for collection of tissue and bodily fluids are
well known in the art and include, for example, urine collection cups, vacuum
containers for blood collection and cups for tissue sainples. It is not
uncominon for a
specimen container to be utilized without a lid or other top tliereon during
placement
of a sample inside. Consequently, while such a specimen container may utilize
a'
plastic lid to seal the cup for transport of the sample(s) to a pathology lab,
there is
nothing thereon to prevent splashing or escaping of fluid and/or tissue during
discharge of a specimen collection instrument. In such a situation, a biologic
hazard
is created for the instrument user. Therefore, lids for specimen containers
have been
proposed that incorporate a diaphragm design for a needle, pipette or test
strip to enter
therein and are generally fashioned to prevent spilling of the fluid or sample
from the
container as it is being placed inside.
[0003] Examples of various specimen containers and sample cups are shown
and described in USPN 2,196,785, entitled "RUBBER STOPPER FOR BOTTLES,
JARS, VESSELS, AND LIKE CONTAINERS" issued 04/09/40; USPN 2,436,291,
entitled "SELF-SEALING CLOSURE FOR CONTAINERS" issued 02/17/48; USPN
2,957,503, entitled "PILL DISPENSER" issued 10/25/60; USPN 3,478,922, entitled
"SELF-CLOSING VAPOR CONTROLLING CAP" issued 11/18/69; USPN
3,629,873, entitled "CONTAINER STRUCTURE" issued 12/18/71; USPN 4,040,791,
entitled "SPECIMEN COLLECTING DEVICE" issued 08/09/77; USPN 4,064,760,
entitled "STERILE URINE COLLECTION DEVICE" issued 12/27/77; USPN
4,248,355, entitled "CLOSURE FOR SAMPLE VIALS" issued 02/03/81; USPN
4,362,698, entitled "CLOSURES FOR FLUID SAMPLE CUPS" issued 12/07/82;
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USPN 4,515,752, entitled "STOPPER FOR CONTAINERS FOR USE IN
ANALYSES" issued 05/07/85; USPN 4,863,453, entitled "STERILE CLOSURE
DEVICE" issued 09/05/89; USPN 4,998,633, entitled "STOPPER FOR A
CONTAINER SUCH AS A BOTTLE AND INCLUDING SLIT VALVE
STRUCTURE, FOR USE WITH A PUMP FOR ALTERING AND THEREAFTER
MAINTAINING ALTERED PRESSURE IN THE CONTAINER" issued 03/12/91;
USPN 5,071,017, entitled "CLOSURE CAP CONSTRUCTION WITH SLITTED
- FLEXIBLE DIAPHRAGM" issued 12/1-0/91; USPN 5,088,612, entitled "VIAL CAP"
issued 02/18/92; USPN 5,111,946, entitled "SAFETY BOTTLE" issued 05/12/92;
USPN 5,169,602, entitled "RESEALABLE CONDUIT AND METHOD" issued
12/08/92; USPN 5,202,093, entitled "SEALING CAP WITH A ONE WAY VALVE
HAVING SEMI-CYLINDRICAL VALVE CLOSURE SPRINGS" issued 04/13/93;
USPN 5,257,984, entitled "BLOOD COLLECTOR" issued 11/02/93; USPN
5,352,413, entitled "DEVICE FOR THE SAFE REMOVAL OF BLOOD FROM A
SUPPLY VESSEL" issued 10/04/94; USPN 5,395,590, entitled "VALVED
CONTAINED LID" issued 03/07/95; USPN 5,458,854, entitled "COLLECTION
ASSEMBLY" issued 10/17/95; USPN 5,511,557, entitled "URINE SPECIMEN
COLLECTION DEVICE" issued 04/30/96; USPN 5,611,792, entitled "VALVE
DEVICE FOR ASEPTIC INJECTION AND REMOVAL OF A MEDICAL FLUID
INTO/FROM A CONTAINER" issued 03/18/97; USPN 5,753,186, entitled
"REACTION TUBE WITH A PENETRABLE MEMBRANE TO MINIMIZE
CONTAMINATION" issued 05/19/98; USPN 5,904,677, entitled "STERILE
SPECIMEN CAPTURE DEVICE" issued 05/18/99; USPN 6,030,582, entitled
"SELF-RESEALING, PUNCTURABLE CONTAINER CAP" issued 02/29/00;
USPN 6,054,099, entitled "URINE SPECIMEN CONTAINER" issued 04/25/00;
USPN 6,173,851, entitled "METHOD AND APPARATUS FOR THE INTERIM
STORAGE OF MEDICATED ORAL DOSAGE FORMS" issued 01/16/01; USPN
6,210,909, entitled "LIQUID SPECIMEN CONTAINER AND ATTACHABLE
TESTING MODULES" issued 04/03/01; USPN 6,277,646, entitled "FLUID
SPECIMEN COLLECTING AND TESTING APPARATUS" issued 08/21/01; USPN
6,286,698, entitled "METHODS AND APPARATUS FOR THE INTERIM
STORAGE OF MEDICATED ORAL DOSAGE FORMS" issued 09/11/01; USPN
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6,361,744, entitled "SELF-RESEALING CLOSURE FOR CONTAINERS" issued
03/26/02; USPN 6,402,407, entitled "DEVICE FOR HOLDING A WRITING
INSTRUMENT" issued 06/11/02; USPN 6,409,970, entitled "BIOPSY
COLLECTION SYSTEM" issued 06/25/02; USPN 6,509,164, entitled "LIQUID
SPECIMEN CONTAINER AND ATTACHABLE TESTING MODULES" issued
01/21/03; USPN 6,589,749, entitled "LIQUID SPECIMEN CONTAINER AND
ATTACHABLE TESTING MODULES" issued 07/08/03; and USPN 6,716,396,
entitled "PENETRABLE CAP" issued 04/06/04; each of which is incorporated by
reference herein in its entirety.
[0004] Many of the above-referenced patents include sample cups having lid
closure devices that utilize rubber bladders, liners, lips, etc. to prevent
escape of fluid
and/or tissue during discharge of the sample from an instrument inserted
tlierethrough.
Such designs may be optimal and preferable for large gauge needles or otlier
small
diameter instruments. However, for small gauge needles and other instruments
having inuch larger diameters, such as certain biopsy needles, insertion
thereof
through a solid material (e.g., rubber gasket, septum, etc.) is not only
difficult for the
user, but will tend to cut the material, contaminating both the biopsy sample
and the
needle. Such contamination is problematic, for example, in the case of a
biopsy
needle due to the fact that in a typical biopsy procedure numerous samples are
talcen
using the same needle.
BRIEF SUMMARY OF THE INVENTION
[0005] Accordingly, described herein is a specimen cup having a tissue
collection lid configured to prevent escape of fluid and/or tissue from the
specimen
cup during ejection of the fluid and/or tissue from a sampling instrument,
such as a
biopsy needle. In addition, the tissue collection lid is also configured to
remove
excess fluid and/or tissue remaining in the sampling instrument as the
sampling
instrument is withdrawn from the specimen cup. The tissue collection lid
described
herein may be utilized with various types of specimen cups or containers,
having
different sizes, shapes and materials. The tissue collection lid may be
configured to
be pressed into an open specimen cup or container, such that the lid forms a
fluid tight
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seal therewitli, or may be otherwise configured to form a sealing connection
with a
specimen cup or container (e.g., threaded configuration).
[0006] In one aspect, a lid for a container includes a rim defining a.n
opening,
the rim including an upper section and a lower section, the lower section
being
configured for insertion into an open end of a container, and a fla.nge
connected to the
upper section of the rim, the flange being positioned within the opening, the
flange
including an aperture and a plurality of slits, the plurality of slits
extending radially
from the aperture toward the rim.
[0007] In another aspect, a lid for a container includes a rim defining an
opening, the rim including an upper section and a lower section, the lower
section
being configured for insertion into an open end of a container, the rim
including
means for forming a seal upon insertion of the lower section into an open end
of a
container, and a flange of different material than the rim, an outer edge of
the flange
being embedded in the upper section of the rim such that the flange is
positioned
within the opening, the flange including an aperture and a plurality of slits,
the
plurality of slits extending radially from the aperture toward the rim,
creating a
plurality of flange meinbers.
[0008] In one aspect, a tissue collection lid includes a rim and a flange, the
rim including an upper section and a lower section, the flange including a
plurality of
slits extending radially outward from an aperture in a mid-region thereof
toward the
rim. The rim defines an opening therethrough and the flange is positioned
within the
opening. The flange in one embodiment is embedded in the upper section of the
rim.
The slits of the flange may be arranged spaced apart from one another to
create
similarly shaped flange members that are capable of independent flexing with
respect
to one another. The flange may be of a different material than the rim and in
one
embodiment is made of a metal material to reduce the likelihood of
contamination. In
one aspect, the rim is made of a low density polyethylene material, while the
flange is
made of a stainless steel material. In another aspect, the lower section of
the rim
includes gripping barbs arranged around an outer surface thereof to provide a
seal
with a specimen cup into which it is inserted. In another aspect, the rim is
circular in
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shape and the upper section has an outer diaineter that is greater than that
of the lower
section.
[0009] In yet another aspect, a method of ejecting a biopsy sample into a
specimen cup is provided. The method can be achieved by inserting a distal end
of a
biopsy needle through a lid of the specimen cup, the lid including a flange
with an
aperture and a plurality of slits, the plurality of slits extending radially
from the
aperture toward the rim, creating a plurality of flange members, the biopsy
needle
being inserted through the aperture, ejecting the biopsy sample into the
specimen cup,
and removing material disposed in a part of the biopsy needle via at least one
of the
flange members. In still another aspect, a method of reducing contamination of
a
biopsy sample is provided. The method caii be achieved by providing a
plurality of
flange members arcuately disposed about a central opening, inserting a biopsy
needle
having a material hardness equal to or less than the material hardness of the
flange
members through the central opening, and removing material disposed in a part
of the
biopsy needle via at least one of the flange members.
[0010] ~ - ~) These and other embodiments, features and advantages of the
present
inventioii will become more apparent to those skilled in the art when taken
with
reference to the following more detailed description of the invention in
conjunction
with the accompanying drawings that are first briefly described.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a side perspective view of one embodimeht of a tissue
collection lid and a specimen cup.
[0012] FIG. 2 is a side perspective view of the tissue collection lid of FIG.
1
inserted within the specimen cup.
[0013] FIG. 3 is a top perspective view of the tissue collection lid of FIG.
1.
[0014] FIG. 4 is side perspective view of the tissue collection lid and
specimen cup of FIG. 2, showing a biopsy needle inserted through the tissue
collection lid.
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[0015] FIG. 5 is a view of the biopsy needle of FIG. 4 being withdrawn from
the specimen cup through the tissue collection lid.
[0016] FIG. 6 is a top view of one embodiment of a flange of a tissue
collection lid.
[0017] FIG. 7 is a bottom view of a tissue collection lid.
[0018] FIG. 8 is a cross-sectional view of the tissue collection lid of FIG.
7.
[0019] FIG. 9 is an enlarged cross-sectional view of a section of FIG. 8.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0020] The following detailed description should be read with reference to the
drawings, in which like elements in different drawings are identically
numbered. The
drawings, which are not necessarily to scale, depict selected preferred
embodiments
and are not intended to limit the scope of the invention. The detailed
description
illustrates by way of example, not by way of limitation, the principles of the
invention. This description will clearly enable one skilled in the art to make
and use
the invention, and describes several embodiments, adaptations, variations,
alternatives
and uses of the invention, including what is presently believed to be the best
mode of
carrying out the invention.
[0021] The tissue collection, lid described herein is designed to serve a
number
of purposes, depending,on the type of instrument used and the application of
use. In a
medical context, the tissue collection lid is designed, for example, to
prevent biologic
hazard associated with the splash of biologic fluids, while also aiding in the
removal
of fluid and/or tissue from a sampling instrument, such as a biopsy needle.
The tissue
collection lid, as described herein, may optimally be designed for use with an
instrument having a biopsy needle of small gauge with a port in a distal end
thereof
designed to hold a biopsy sample, such as the Bard VacoraTM Vacuum Assisted
Biopsy System, manufactured by Bard Biopsy Systems, a business unit of Bard
Peripheral Vascular, Inc. of Tempe, Arizona, which is disclosed in WO
03/077767
and WO 03/077768, each of wliich is incorporated by reference herein in its
entirety.
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While the examples provided herein are with respect to use of the tissue
collection lid
with a biopsy needle, one of skill in the art would appreciate that the tissue
collection
lid described herein could also be used with various other instruments.
Therefore, the
scope of the invention should not be limited for use with a biopsy needle
instrument,
and is not intended to be so limited.
[0022] The tissue collection lid as described herein may be made of different
materials and can be fashioned in different shapes and sizes, depending on the
shape
and size of the specimen cup or other container with which it is to be used.
In the
embodiment described herein, the tissue collection lid can be circular to fit
within a
cylindrical specimen cup and can include a rim made of a plastic material
(e.g., low
density polyethylene) and a flange made of a metal material (e.g., stainless
steel). The
hardness of the flange material can be less than, equal to or substantially
equivalent to
the hardness of the biopsy needle. For example, if the biopsy needle is made
of 316
stainless steel (Rockwell 'B' hardness of approximately 92) and the flange is
made of
304 stainless steel (Rockwell 'B' hardness of approximately 95), the flange
hardness
is less than that of the biopsy needle. In another example, the flange a.nd
biopsy
needle are made from materials with approximately equivalent hardness.
[0023] Referring to FIG. 1, a tissue collection lid 10 and specimen cup 20 are
shown in a disassembled state. It can be seen from this view that the tissue
collection
lid 10 includes a rim 12 and a flange 30, the rim 12 including a lower section
16 and
an upper section 14. An opening is defined by the inner circumference of the
upper
section 14 and extends througll the rim. In the embodiment shown in FIG. 1,
the
upper section outer diameter is greater than the lower section outer diameter,
while
the lower section inner diameter is greater than the upper section inner
diameter (FIG.
8). The flange 30 is positioned within the opening of the rim 12. In the
assembled
view of FIG. 2, the tissue collection lid 10 is placed into an open end of the
specimen
cup 20. The lower section 16 is pressed into the open end of the specimen cup
20,
fitting tightly against the inside wall thereof. In one embodiment, the tissue
collection
lid 10 can be interference fitted (e.g., slip fit or permanent fit) due to
closely
toleranced diameters of the lower section and the open end of the container so
that a
fluid tight seal can be achieved when the tissue collection lid 10 is placed
into the
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specimen cup 20. Of course, if the specimen cup is formed with a square,
rectangle,
triangle or other-shaped cross-section, the tissue collection lid would be
configured in
a similar manner to provide a fluid tight seal. Other configurations for
securing the
lid to a specimen cup can also be utilized in the examples described herein,
such as a
threaded arrangeinent.
[0024] In the embodiment shown, the upper section 14 of the rim 12 is made
of the same material as the lower section 16 (e.g., low density
polyetliylene), the
entire rim 12 being manufactured as one unit, for example through an injection
molding process. The flange 30, including a plurality of flange members 32, is
made
of a different material (e.g., stainless steel) in this embodiment, and is
embedded in
the wall of the upper section 14 by methods known to one of skill in the art,
such as
by insert overmolding. It should be noted that by fashioning the flange 30
from a
metal or other like material, contamination (which would likely occur if the
flanges
were made of plastic) can be largely avoided or at least significantly
reduced. The
flange 30 in this embodiment includes flange members 32 in the form of eight
triangular or pie-shaped segments, although certainly any number of segments
would
be possible (three, four, five, six, ten, twelve, etc.). Also, an embodiment
of a flange
can include a single flange member. In one embodiment, the flange 30 is
created by
forming an aper-ture 18 in a solid piece of material and cutting a plurality
of slits 34
(e.g., through laser-cutting, etc.) through a surface thereof around the
circumference
of the aperture 18 and extending radially outward to a perimeter 36 (FIG. 6).
It
should be appreciated that although the flange members illustrated herein are
of
similar shape and size, other embodiments include flange members having
different
shapes and/or sizes, which may be advantageous, for exainple, in facilitating
removal
of tissue from different sized/shaped instruments. In such embodiments, the
slits may
not be radially oriented. For example, the slits may be cut to form dissimilar
flange
members.
[0025] The size of the aperture 18 may be adjusted based on the size of the
instrument that is intended for insertion into the specimen cup and may be
created in
the flange 30 by removing through a cutting process, as discussed above.
Moreover,
the aperture 18 is configured to ensure that an instrument can be easily
inserted
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through the opening, while simultaneously ensuring that the opening will be
sufficiently closed when the instrument is inserted to prevent escape of fluid
and/or
tissue tlierethrough. Further, while the aperture 18 shown in the tissue
collection lid
is circular, it should be appreciated that any shape or size is possible,
depending on
5 the shape and size of the instrument intended for insertion tlierethrough.
The slits 34
defining flange members 32, as seen best in FIGS. 6-7, do not extend to the
outer
edge of the flange 30 and instead stop short a predetermined length therefrom
at
perimeter 36. This perimeter in one embodiment is within the inner
circumference of
the rim 12. Such a configuration removes the possibility of gaps for fluid or
tissue to
10 escape when a needle or other instrument is inserted through the opening of
the tissue
collection lid, which possibility exists in a flange in which the slits
defining the flange
members extend to the outermost perimeter of the tissue collection lid.
[0026] Referring to FIG. 4, the tissue collection lid 10 and specimen cup 20
are shown with a biopsy needle 40 being inserted through the aperture 18 in
the tissue
collection lid. Once the tissue port of the biopsy needle 40 is within the
specimen cup
20, an ejection procedure can take place to release the tissue sample into the
specimen
cup. For instance, a sample port of the biopsy needle 40 is covered by a
sheath or
other component of the biopsy needle for insertion into the specimen cup; once
the
sample port has been coinpletely inserted through the lid 10, the sample port
is
uncovered and the sample is ejected. The flange 30 prevents any fluid or
tissue
sainple that splashes off the bottom or sides of the specimen cup 20 from
escaping
therefrom. FIG. 5 illustrates the biopsy needle being withdrawn from the
specimen
cup 20, following ejection of the tissue sample. Due to the configuration of
the flange
30, as the needle 20 is withdrawn, one or more edges of the flange members 32,
including the edges defining the aperture 18 and the side edges created by
slits 34,
scrape any remaining tissue sample from the port of the biopsy needle 40 for
deposit
within the specimen cup 20,. Thus, no other surgical instruments are necessary
for
clearing the port of the biopsy needle 40, which is advantageous in terms of
time and
expenditure (e.g., cost for additional instruments).
[0027] FIG. 6 is a top perspective view of the flange 30 in isolation, showing
the aperture 18 in the mid-point thereof, as well as the slits 34, which
define the
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individual flange members 32, extending radially from the aperture 18 to the
perimeter 36. Although the aperture 18 is shown in the mid-point of flange 30
in this
embodiment, other embodiments include an aperture that is off-center such that
the
flange members of a circular flange are of different length. In such
embodiments, the
flexural stiffness of the flange members may be different, meaning that the
tissue
collection lid provides stiffness variety among the flange meinbers to provide
the user
several options for tissue extraction depending on need and/or preference.
Further,
the perimeter 36 can be sized to control the stiffness of the flanges and
therefore the
ease of probe insertion and/or tissue extraction. The thickness of the flange
will also
affect ease of insertion and tissue extraction and therefore can be sized
according to
user need and/or preference.
[0028] In one embodiment, the diameter of the flange 30 is approximately
1.580 inches, the diameter of the aperture 18 is approximately 0.148 inches,
the
diameter of the perimeter 36 is approximately 0.556 inches and the thickness
of the
flange is approximately 0.004 inches. FIG. 7 is a bottom view of the tissue
collection
lid 10, showing the underside of the flange 30 and rim 12. FIG. 8 is a cross-
sectional
side view of the tissue collection lid 10, where it can be seen that the
flange 30 is
embedded in the wall of the upper section 14 such that there is a space above
the
flange with respect to the top surface of the upper section 14 (i.e., the
flange is not
flush with the top surface of the upper section 14). Of course, depending on
the
thickness of the flange and/or the upper section, in other embodiments, there
could be
either more or less space above and/or below the flange. In one embodiment,
the
thickness of the upper section adjacent the flange 30 is approximately 0.125
inches,
which is slightly less that the thiclcness of the upper section outer wall,
which is
approximately 0.155 inches; the thickness of the entire rim 12 (i.e., distance
from top
surface of the upper section 14 to the bottom edge of the lower section 16) is
approximately 0.525 inches. Also, in one embodiment, the opening of the upper
section 14 into which the flange 30 resides is approximately 1.380.
[0029] It is noted here that although FIGS. 6-9 illustrate a planar flange,
there
are other possibilities for the configuration of the flange 30. For example,
in other
embodiments contemplated herein, the flange members extend slightly out of
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(e.g., the edges defining the opening in the middle point slightly upward or
downward) to create a funnel profile in cross-section. Such a configuration
may be
fiu-ther advantageous in providing a sealing and/or cleaning function as a
needle is
inserted through and withdrawn from the tissue collection lid.
[0030] FIG. 8 illustrates gripping barbs 17 extending outward from the lower
section 16, FIG. 9 providing a detailed view thereof. This feature in tissue
collection
lid 10 ensures a fluid tight, friction fit connection between the tissue
collection lid and
the specimen cup into which it is placed. The gripping barbs 17 have an angled
base
that extends to a top surface that is perpendicular with respect to the side
of the lower
section 16 from which they extend so that wlien the tissue collection lid 10
is placed
into specimen cup 20, the barbs 17 will bend slightly in an upward direction,
ensuring
a tight fit and preventing the lid from accidentally becoming dislodged from
the
specimen cup (positive force is required to remove the tissue collection lid
from the
specimen cup). In one embodiment, this angle is approximately 47 with respect
to
the top surface of the barb, although other angles would be equally suitable.
It is also
noted that the side of the lower section 16 is slightly angled from the bottom
edge
thereof to the first barb 17 (FIG. 9). In one embodiment, this angle is
approximately
80 with respect to the top surface of the first barb 17. The gripping barbs
as shown
herein are representative of one feature for a tissue collection lid for
keeping the tissue
collection lid firmly secured within a specimen cup and providing a seal
therewith.
Thus, the gripping barbs, the interference fit between the lower section and
open end
of the container, elastomeric seal, glue, sealant and other suitable seals can
be the
means for forming a seal upon insertion of the lower section into the open end
of the
container.
[0031] This invention has been described and specific examples of the
invention have been portrayed. While the invention has been described in terms
of
particular variations and illustrative figures, those of ordinary skill in the
art will
recognize that the invention is not limited to the variations or figures
described. In
addition, where methods and steps described above indicate certain events
occurring
in certain order, those of ordinary skill in the art will recognize that the
ordering of
certain steps may be modified and that such modifications are in accorda.nce
with the
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variations of the invention. Additionally, certain of the steps may be
performed
concurrently in a parallel process when possible, as well as performed
sequentially as
described above. Therefore, to the extent there are variations of the
invention, which
are within the spirit of the disclosure or equivalent to the inventions found
in the
claims, it is the intent that this patent will cover those variations as well.
Finally, all
publications and patent applications cited in this specification are herein
incorporated
by reference in their entirety as if each individual publication or patent
application
were specifically and individually put forth herein.
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