Note: Descriptions are shown in the official language in which they were submitted.
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FOR: COLLECTION CONTAINER ASSEMBLY
0 BACKGROUND OF THE INVENTION
1 Field of the Invention
This invention relates to a specimen collection container assembly and more
5 particularly to a collection container for collecting biological fluid specimens where
a small quantity of fluid may be collected and retained in the container while
maintaining a container size sufficient to be easily accommodated and/or
compatible with standard clinical equipment and instrumentation.
2 Description of Related Art
Blood samples and other biological fluid specimens are routinely taken and
analyzed in hospital and ~linic~l situations for various medical purposes.
Collection, han-lling and testing of these samples typica~ly requires the use of2s various medical testing instruments. As the blood and fluid specimens are usually
collected in a standard sized collection tube, the medical instruments used to test
the samples are designed to accommodate these standard sized collection tubes
Conventional blood collection tubes used in most clinical situations are
30 elongated cylindrical containers having one end closed by a semi-spherical orrounded portion and an opposed open end. The open end may be sealed by a
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resilient cap or stopper. The tube defines a collection interior which collects and
holds the blood sample. The most common size of these blood collection tubes aredesigned to accommodate approximately 10 ml of blood or other biological fluid
samples. Illustrative of such blood collection tubes is the VACUTAINER~9 brand
s blood collection tube sold by Becton, Dickinson and Company, 1 Becton Drive,
Franklin Lakes, NJ (registered trademark of Becton, Dickinson and Company).
A phlebotomist or other medical tel hni(~ n typically obtains a specimen of
the patient's blood in the tube by techniques well known in the art. The tube is0 then appropriately labeled and transferred from the site of collection to a laboratory
or other location where the contents of the tube are analyzed. During collection and
analysis the tube may be supported by various medical instruments. The plasma orserum derived therefrom is processed and analyzed either manually, semi-
automatically or automatically. In some cases, the specimen must first be
5 dispensed from the collection tube to a sample test tube or cuvette.
In certain situations it is only necessary to obtain a small quantity of blood or
other biologi~l fluid specimens. These situations may include pediatric, or
geriatric patients and other instances where large blood samples are not required.
20 Small quantities of blood cannot be easily collected in standard collection tubes as
~lesrribed above because the sample level in such containers would not be adequate
for retrieval prior to analysis. Such small quantities of fluids also have a tendency
to .~ignifirc~ntly evaporate when stored in larger containers, thus concentrating the
chemical and enzymatic constituents therein. This may result in erroneous
2~ analytical results and could possibly affect the diagnosis and treatment given the
patient. Thelefole, it is desirable to employ small-volume con~iners which
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substantially inhibit evaporation for the storage and delivery of minute fluid
samples in the laboratory.
Various specimen containers such as those incorporating a "false bottom"
s have been proposed to achieve decreased volume capacity in conjunction with
standard external dimensions. However, these various specimen containers are notcompatible with standard ~.linic~l equipment and instrumentation due to their
lle.~ign In particular, these specimen containers have false bottoms with a
generally flat, planar bottom end and a circular shaped opening.
Other specimen containers include partial-draw tubes which have standard
extern~l dimensions with partial evacuation so that blood fills only a portion of the
internal volume However, partial-draw tubes exhibit a reduction in the draw rateof a sample which reduces the collection efficiency of such tubes. In addition,
5 partial-draw tubes may result in an inconsistent fill volume which may alter test
results. Furthermore, it is difficult to determine the accurate sample quantities
with such partial-draw tubes because the slow rate of sample draw is not
consistently measurable.
In l~linic~ql use, it is desirable for such specimen collection containers to have
rounded bottom configurations that closely simulate a standard-sized blood
collection tube configuration instead of planar bottoms. Rounded bottom
configurations facilitate compatibility with clinical equipment and instrumentation.
2s Therefore there is a need to provide a specimen collection container assembly
for collecting blood samples and other biological fluid specimens of relatively small
volumes where the assembly may be accommodated and/or compatible with
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standard ~.linic~ql equipment and/or instrumentation and where the integrity of the
sample and specimens are maintained during draw, storage and transport
SUMMAB~Y OF THE INVENTION
s
The present invention is a collection assembly comprising a first container
and a second container. The first container preferably comprises an open top
portion, a bottom portion and a sidewall extending from the open top portion to the
bottom portion. The bottom portion comprises a closed bottom end or true bottom
o and an annular skirt extending from the closed bottom end to a stop end at a lower
bottom portion. The assembly further comprises a second container that may be
secured and unsecured to the lower bottom portion of the container.
Most preferably, the second container comprises a top portion, a bottom
5 portion, a sidewall extending from the top portion to the bottom portion and an
open end associated with the top portion having an integral connector Most
preferably, the integral connector has an inner surface, an outer surface, and ribs
associated with the outer surface of the connector. Most preferably, the bottom
portion is fully rounded or substantially spherical in shape. Most preferably, the
20 integral connector fits or mates with the lower bottom portion of the annual skirt of
the first container.
The second container is removably secured to the first container whereby the
integral connector is inserted into the annular skirt of the first container by force or
2s friction fit. Thereby, the second container provides the assembly with a false
bottom end that is rounded. The second container may be the same or different
material than the first container. The second container is removably unsecured
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from the first container whereby the user slightly twists the first container and the
second container in opposite rotating directions thereby releasing the integral
connector from the annual skirt and removing the second container from the firstcontainer.
s
The annular skirt of the container provides a false bottom effect to the
assembly and the second container provides a means for allowing the first container
to be modified so as to be compatible with standard clinical equipment and
instrumentation .
o
The true bottom may be the same or different material than the first
container and may be integral with the container or may be a discrete member.
Additionally, the true bottom may be arcuate in shape to provide an internal
volume for specimen collection having at least a partially rounded true bottom
5 portion, or may be conical in shape.
In addition, the assembly may further comprise a closure such as a cap or a
stopper at the open end of the first container.
Preferably, the external dimensions of the assembly which includes the first
container and the second container are substantially the same as a standard-sized
or full draw blood collection container assembly.
Most preferably, the assembly of the present invention can be either
2s evacuated or non-evacuated. Desirably, the assembly is made from polyethylene
terephthalate, polypropylene, polyethylene, polyethylene napthalate polyvinyl
chloride or copolymers thereof.
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An advantage of the assembly of the present invention is that it provides a
full-draw blood collection container assembly having a reduced internal volume but
with external dimensions about the same as a standard-sized blood collection
s container assembly.
A further advantage of the assembly of the present invention is that it
provides a specimen collection container which is universally compatible with
various ~linic~l equipment and instrumentation.
The assembly of the present invention may be easily handled by equipment
configured to handle standard-sized blood collection tubes having standard external
dimensions.
Most notably, is that the assembly of the present invention provides a blood
collection container having full draw external dimensions but with a reduced
internal volume as compared to standard-sized full draw blood collection.
Standard-sized full draw blood collection containers have an outer diameter
20 of about 13 to about 16 millimeters, a length of about 75 to about 100 millimeters
and an internal volume of about 6 to about 10 milliliters.
The assembly of the present invention therefore addresses the need for a full-
draw low-volume blood collection container assembly that presents the external
2s dimensions of a standard-sized blood collection tube.
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The assembly of the present invention may be used to reliably collect small
samples of blood or biological fluids and to maintain the integrity of the samples
during storage and transport as compared to using standard-sized blood collection
tubes. In addition, the assembly of the present invention can also be accommodated
s by standard-sized blood collection, transportation, storage, and diagnostic
equipment.
Most notably, is that the assembly of the present invention provides a
rounded bottom configuration that is substantially the same as a standard-sized
o blood collection tube with a fully rounded bottom. This particular feature in
conjunction with all of the features of the container, distinguishes it from thespecimen containers that have flat planar bottoms.
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The assembly of the present invention is also compatible with existing
instrumentation, labels, and bar code readers and obviates the need for new
instrumentation and handling devices or procedures that would be required for
s smaller or varying sized tubes or tubes with flat planar bottoms.
DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of a false bottom specimen tube of the prior art.
FIG. 2 is a longitudinal sectional view of the tube of FIG. 1 taken along line
2-2 thereof.
FIG. 3 is a perspective view of the assembly of the present invention with the
5 second container unsecured from the first container.
FIG. 4 is a longitudinal sectional view of the assembly of FIG. 3 taken along
line 4-4 thereof with the second container removably secured to the first container.
20FIG. 5 illustrates the removal of the second container from the first
container.
FIG. 6 is a perspective view of an alternate embodiment of the present
invention.
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DETAILED DESCRIPTION
The present invention may be embodied in other specific forms and is not
limited to any specific embodiment described in detail which is merely exemplary.
s Various other modifications will be apparent to and readily made by those skilled in
the art without departing from the scope and spi~t of the invention The scope ofthe invention will be measured by the appended claims and their equivalents.
Referring to the drawings in which like reference characters refer to like
o parts throughout the several views thereof, FIGS. 1 and 2 show a false bottom
specimen container 10 of the prior art, having a sidewall 12 having an outer surface
14 and an inner surface 16. Cylindrical sidewall 12 extends from an upper portion
18 to a lower portion 20. Upper portion 18 includes an open end 22 and a rim 24.Lower portion 20 comprises a closed bottom end 26. An annular skirt 28 extends
lS from lower portion 20 and outer surface 14 to a flat planar bottom end 30 to define
an open false bottom area 36. Interior volume 34 extends between rim 24 and
closed bottom end 26.
~P.ferr-ng to the drawings in which like reference characters refer to like
20 parts throughout the several views thereof, FIGS. 3 and 4 show the preferred
embo&ent of the present invention, assembly 50. Assembly 50 comprises a first
specimen container 52, having a cylindrical sidewall 62 having an outer surface 64
and an inner surface 66. Sidewall 62 extends from an upper portion 68 to a lowerportion 70. Upper portion 68 includes an open end 72 and an integral neck 74.
2s
Integral neck 74 has a first cylindrical sidewall 76 that extends from a rim
77 to a second cylindrical sidewall 78. Second cylindrical sidewall 78 has an
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~xtern~l diameter less than the external diameter of first cylindrical sidewall 76.
Second cylindrical sidewall 78 tapers inwardly towards cylindrical sidewall 62,
wherein the external diameter of sidewall 62 is less than the external diameter of
second cylindrical sidewall 78. First cylindrical sidewall 76 includes an inner
s surface 80 an outer surface 82 and threads 84 located on outer surface 82 for cooperating with threads on a closure.
Lower portion 70 of assembly 50 comprises a closed bottom end or true
bottom 86. An annular skirt 88 having an outer surface 90 and an inner surface
o 92, extends from lower portion 70 and outer surface 64 to a bottom end or false
bottom end 94 to define an open false bottom area 96 and planar rim surface 98.
An interior volume 99 extends between rim 77 and closed bottom end 76.
Closed bottom end 76 may be positioned at any point below rim 77 thus
s providing a variable interior volume 99. Closed bottom end 76 may be generally
flat or planar in shape to provide a flat bottom surface for interior volume 99.Alternatively, closed bottom end 76 may be arcuate in shape to provide at least a
partially rounded bottom surface for interior volume 99. Most preferably, closedbottom end is generally conical in shape to provide a conical, pointed bottom surface
20 for interior volume 99. Additionally, closed bottom end 76 may be integral with
sidewall 62 or may be a discrete member. Preferably closed bottom end 76 is
integrally formed with sidewall 62.
As shown in FIGS. 3 and 4, second container 100 includes a top portion 102,
25 a bottom portion 104, a cylindrical sidewall 106 extending from the top portion to
the bottom portion, an open end 108 associated with top portion 102 and an
integral connector 110 extending from top portion 102. Integral connector 110
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extends between a top portion 112 and a bottom portion 114 having a cylindrical
sidewall 116 that includes an inner surface 118 and an outer surface 120. A
plurality of ribs 122 are associated on outer surface 120. Cylindrical sidewall 116
has an external diameter less than the external diameter of cylindrical sidewalls 106. The bottom portion of the integral connector is connected to top portion 102 by
a flat shoulder surface 124 Bottom portion 104 is fully rounded or substantiallysemi-spherical in shape.
As shown in FIG. 4, assembly 50 has an outer diameter A of about 16
10 millimeters, a length B of about 75 millimeters, as measured from rim 74 to bottom
portion 104 of second container 100, and an interior volume 94 of about 1 to 3
mil~iliters. It is within the purview of this invention that assembly 50 may have an
outer diameter of about 13 to about 16 millimeters, a length of about 75 to about
100 millimeters and an interior volume of about 1 to about 3 milliliters.
Annular skirt 88 provides a means for allowing the container to be placed
upright on a flat surface, as well as providing a meads for converting the assembly
with the second container to substantially the same external dimensions as a
standard-sized blood collection tube.
As shown in FIGS. 4 and 5, second container 100 is readily compatible with
open false bottom area 96. Open false bottom area 96 receives integral connector110 of second container 100 whereby inner surface 92 of annular skirt 88 and ribs
122 of integral connector 110 provide an interference fit and flat shoulder surface
25 124 meets with planar rim surface 98.
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As shown in FIG. 5, the second container may be removed from the first
container whereby the user slightly twists the first container and the second
container in opposite directions thereby removing the second container from the
first container.
s
The invention, as shown in FIG. 6 includes many components which are
substantially identical to the components of FIGS. 3-4. Accordingly, .cimil~r
components performing similar functions will be numbered identically to those
components of FIGS. 3-4, except that a suffix "a" will be used to identify the .simil~r
10 components in FIG. G.
As illustrated in FIG. 6, a further embodiment of the invention is assembly
150 which includes a closure 160.
The embodiment of FIG. 6 may be evacuated or non-evacuated. When
assembly 150 is evacuated, interior volume 99a is typically maintained at a lower-
than-atmospheric internal pressure so that when a blood collection probe
penetrates through the closure placing interior volume 99a in communication withthe circulatory system of a patient, the lower-than-atmospheric pressure of interior
volume 99a will draw blood from the patient into the tube. Assembly 150 may be
Iiesl~.rihed as a full-draw blood collection tube because the internal pressure of
interior volume 99a is low enough to draw a volume of blood substantially equal to
the volume of interior volume 99a.
