Note: Descriptions are shown in the official language in which they were submitted.
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DEVICES AND METHODS FOR USE WITH A SAMPLE CONTAINER
BACKGROUND
[00011 Analyte testing and resulting measurements are often used in
clinical settings to
provide a medical practitioner with data for use in medical decision making.
The method of
obtaining such analyte measurements typically involves some type of sample
collection from. the
subject. The collected sample m.ay include blood, urine, or other liquid
sample. The collection
and processing of such samples can present certain challenges to the personnel
in charge of
sample collection, preparation, and/or handling.
INCORPORATION BY REFERENCE
[00021 All publications, patents, and patent applications mentioned in
this specification
are herein incorporated by reference to the same extent as if each individual
publication, patent,
or patent application was specifically and individually indicated to be
incorporated by reference.
COPYRIGHT
[00031 This document contains material subject to copyright protection.
The copyright
owner (Applicant herein) has no objection to facsimile reproduction of the
patent documents and
disclosures, as they appear in the US Patent and Trademark Office patent file
or records, but
otherwise reserves all copyright rights whatsoever. The following notice shall
apply: Copyright
2013-2015 Theranos, Inc.
SUMMARY
100041 The disadvantages associated with the prior art are overcome by at
least some
embodiments described herein.
100051 In one embodiment, a device is provided for use with a sample
container. This
non-limiting example of the device comprises a first portion shaped to contain
at least a portion
of the sample container; a second portion configured for user handling and
force application; and
a guide portion sized and shaped to be received in a channel of a bulk sample
container; wherein
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the first portion and second portion are sized to minimize thermal transfer
between a user and the
sample container.
100061 in another embodiment, a device is provided for use with a sample
container.
This non-limiting example of the device comprises a first portion shaped to
contain at least a
portion of the sample container; a second portion configured for user handling
and force
application from a proximal end of the device; and a guide portion.
100071 in another embodiment, a device is provided for use with a sample,
such as but
not limited to a bodily fluid sample. This non-limiting example of the device
comprises a first
portion defining a sample container; a second portion configured for user
handling and force
application from a proximal end of the device; and a guide portion.
100081 Optionally, any of the embodiments herein may be adapted with one
or more of
the following. For example, the first portion may define a cavity for holding
the sample
container. Optionally, the second portion defines at least a bottom surface of
the device.
Optionally, the second portion defines a grip surface on the device.
Optionally, the second
portion defines an indented grip feature on the device. Optionally, the guide
portion defines at
least one interface surface that is configured to contact at least a portion
of the channel.
Optionally, the guide portion has a cross-sectional shape matching a channel
cross-sectional
shape. Optionally, the second portion has at least one flat side to prevent
undesired rolling of the
device when placed on a side surface. Optionally, the channel comprises an
access channel.
Optionally, the channel comprises a guide channel. Optionally, the first
portion and second
portion comprise a thermally insulating material. Optionally, the first
portion and second portion
provide a dual function device that is both a device alignment guide and a
reduced thermal
conductivity user handling surface. Optionally, the first portion defines a
plurality of openings
configured to show the sample container when the sample container is
positioned therein.
Optionally, the first portion defines view windows into a container holding
area of the device.
Optionally, the sample container has a length along a longitudinal axis that
is less than a length
along a longitudinal axis of the device. Optionally, a cartridge is provided
that is sized to receive
the sample container, wherein the sample container has a length allowing the
sample container to
be placed substantially fully within the cartridge while the sample container
is in a non-
horizontal orientation. Optionally, the device has a length along a
longitudinal axis that is less
than a height of the cartridge. Optionally, a cartridge is provided that is
sized to receive the
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sample container, wherein the sample container has a length allowing the
sample container to be
placed substantially fully within the cartridge while the sample container is
in a non-horizontal
orientation. Optionally, the sample container comprises a septa in at least
one end of the
container, wherein the septa defines a re-sealable fluid access port.
Optionally, the sample
container comprises a liquid impermeable, gas permeable vent. Optionally, the
sample container
comprises a vent.
100091 it should be understood that embodiments in this disclosure may be
adapted to
have one or more of the features described below. In one nonlimiting example,
other non-blood
samples can be used in the container, such as but not limited to semen,
vaginal fluid, or other
liquid sample.
100101 In at least another embodiment described herein, a device is
provided for use with
a sample, the device comprising: a first portion defining a sample container;
a second portion
configured for user handling and force application from a proximal end of the
device.
[0011) In at least another embodiment described herein, a method is
provided for use
with a sample, the method comprising: using a sample container having a first
portion and a
second portion, wherein the second portion configured for user handling and
force application
from a proximal end of the device.
[00121 In at least another embodiment described herein, a method is
provided for use
with a sample, the method comprising: using a sample container having a first
portion and a
second portion, wherein the second portion configured for user handling and
force application
from a proximal end of the device, wherein the sample container has an
internal volume of about
200 microliters or less.
100131 In at least another embodiment described herein, a method is
provided for use
with a sample, the method comprising: using a sample container having a first
portion and a
second portion, wherein the second portion configured for user handling and
force application
from a proximal end of the device, wherein the sample container has an
internal volume of about
300 microliters or less.
100141 in at least another embodiment described herein, a method is
provided for use
with a sample, the method comprising: using a sample container having a first
portion and a
second portion, wherein the second portion configured for user handling and
force application
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from a proximal end of the device, wherein the sample container has an
internal volume of about
400 microliters or less.
100151 in at least another embodiment described herein, a method is
provided for use
with a sample, the method comprising: using a sample container having a first
portion and a
second portion, wherein the second portion configured for user handling and
force application
from a proximal end of the device, wherein the sample container has an
internal volume of about
500 microliters or less.
100161 Optionally, any of the embodiments herein may be adapted with one
or more of
the following. For example, a device at least one technical feature from one
or more of the
embodiments herein. Optionally, a method may comprise at least any two
technical features
from one or more of the embodiments herein. Optionally, a device may comprise
at least one
technical feature from one or more of the embodiments herein. Optionally, a
device may
comprise at least one or more two technical features from one or more of the
embodiments
herein. Optionally, a system may comprise at least one technical feature from
one or more of the
embodiments herein. Optionally, a system may comprise at least any two
technical features from
one or more of the embodiments herein.
100171 This Summary is provided to introduce a selection of concepts in a
simplified
form that are further described below in the Detailed Description. This
Summary is not intended
to identify key features or essential features of the claimed subject matter,
nor is it intended to be
used to limit the scope of the claimed subject matter.
BRIEF DESCRIPTION OF THE DRAWINGS
100181 Figures 1 A to IB show perspective views of one embodiment as
described herein.
100191 Figures 2A to 2B show perspective views of another embodiment as
described
herein.
100201 Figures 3A to 3C show perspective views of other embodiments as
described
herein.
100211 Figures 4A to 4B show perspective views of other embodiments as
described
herein.
100221 Figures 5A to 5C show various views of embodiments as described
herein.
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100231 Figures 6A to 7B show methods of using sample containers to engage
larger
containers according to various embodiments herein.
100241 Figure 8 shows a perspective view of a cartridge configured to
receive at least one
sample container according to an embodiment as described herein.
DESCRIPTION OF THE SPECIFIC EMBODIMENTS
100251 it is to be understood that both the foregoing general description
and the
following detailed description are exemplary and explanatory only and are not
restrictive of the
invention, as claimed. It may be noted that, as used in the specification and
the appended claims,
the singular forms "a", "an" and "the" include plural referents unless the
context clearly dictates
otherwise. Thus, for example, reference to "a material" may include mixtures
of materials,
reference to "a compound" may include multiple compounds, and the like.
References cited
herein are hereby incorporated by reference in their entirety, except to the
extent that they
conflict with teachings explicitly set forth in this specification.
100261 In this specification and in the claims which follow, reference
will be made to a
number of terms which shall be defined to have the following meanings:
100271 "Optional" or "optionally" means that the subsequently described
circumstance
may or may not occur, so that the description includes instances where the
circumstance occurs
and instances where it does not. For example, if a device optionally contains
a feature for a
sample collection unit, this means that the sample collection unit may or may
not be present, and,
thus, the description includes both structures wherein a device possesses the
sample collection
unit and structures wherein sample collection unit is not present.
100281 As used herein, the terms "substantial" means more than a minimal
or
insignificant amount; and "substantially" means more than a minimally or
insignificantly. Thus,
for example, the phrase "substantially different", as used herein, denotes a
sufficiently high
degree of difference between two numeric values such that one of skill in the
art would consider
the difference between the two values to be of statistical significance within
the context of the
characteristic measured by said values. Thus, the difference between two
values that are
substantially different from each other is typically greater than about 10%,
and may be greater
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than about 20%, preferably greater than about 30%, preferably greater than
about 40%,
preferably greater than about 50% as a function of the reference value or
comparator value.
100291 As used herein, a "sample" may be but is not limited to a blood
sample, or a
portion of a blood sample, may be of any suitable size or volume, and is
preferably of small size
or volume, in some embodiments of the assays and methods disclosed herein,
measurements
may be made using a small volume blood sample, or no more than a small volume
portion of a
blood sample, where a small volume comprises no more than about 5 mL; or
comprises no more
than about 3 mL; or comprises no more than about 2 mL; or comprises no more
than about 1 mL;
or comprises no more than about 500 p.L; or comprises no more than about 250
lit; or comprises
no more than about 100 AL; or comprises no more than about 75 L; or comprises
no more than
about 50 AL; or comprises no more than about 35 L; or comprises no more than
about 25 pL;
or comprises no more than about 20 lit; or comprises no more than about 15 AL;
or comprises
no more than about 10 gL; or comprises no more than about 8 L; or comprises
no more than
about 6 I..; or comprises no more than about 5 lit; or comprises no more than
about 4 AL; or
comprises no more than about 3 pL; or comprises no more than about 2 jaL; or
comprises no
more than about 1 AL; or comprises no more than about 0.8 nt; or comprises no
more than about
0.5 AL; or comprises no more than about 0.3 tit; or comprises no more than
about 0.2 nt; or
comprises no more than about 0.1111.4 or comprises no more than about
0.05111.4 or comprises
no more than about 0.01 pL.
100301 As used herein, the term "point of service location" may include
locations where a
subject may receive a service (e.g. testing, monitoring, treatment, diagnosis,
guidance, sample
collection, ID verification, medical services, non-medical services, etc.),
and may include,
without limitation, a subject's home, a subject's business, the location of a
healthcare provider
(e.g., doctor), hospitals, emergency rooms, operating rooms, clinics, health
care professionals'
offices, laboratories, retailers [e.g. pharmacies (e.g., retail pharmacy,
clinical pharmacy, hospital
pharmacy), drugstores, supermarkets, grocers, etc.], transportation vehicles
(e.g. car, boat, truck,
bus, airplane, motorcycle, ambulance, mobile unit, fire engine/truck,
emergency vehicle, law
enforcement vehicle, police car, or other vehicle configured to transport a
subject from one point
to another, etc.), traveling medical care units, mobile units, schools, day-
care centers, security
screening locations, combat locations, health assisted living residences,
government offices,
office buildings, tents, bodily fluid sample acquisition sites (e.g. blood
collection centers), sites
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at or near an entrance to a location that a subject may wish to access, sites
on or near a device
that a subject may wish to access (e.g., the location of a computer if the
subject wishes to access
the computer), a location where a sample processing device receives a sample,
or any other point
of service location described elsewhere herein.
100311 Referring now to Figures IA and 1B, non-limiting examples of
devices for use
with sample containers are shown. Figure IA shows one embodiment of a sample
container 10
at least partially surrounded by an adapter 20. It should be understood that
the adapter 20, in the
present embodiment, is configured to have an outer peripheral surface that is
sized to engage a
channel, cavity, or other feature on larger sample container. This allows the
sample container 10
to be received in a channel sized for a larger container while the sample
container 10 can be
disengaged from the adapter 20 so that the sample container 10, with its
smaller form factor, can
be received in a cartridge where it is desirable that the sample container 10
occupy a minimum
footprint, minimum volume, or other size requirement. Although Figure IA shows
an adapter 20
with a circular cross-sectional shape for a sample container 10 with a
circular cross-sectional
shape, it should be understood that other embodiments may have a sample
container 10 with one
peripheral cross-sectional shape that is received by an adapter 20 with a
different peripheral
cross-sectional shape. Optionally, some embodiments may have an adapter 20
with both the
inner and outer peripheral surfaces having cross-sectional shapes that do not
match the shape of
the sample container 10.
100321 By way of non-limiting example, one embodiment of container 10 can
be sized to
have an internal volume of about 100 uL or less. Optionally, another
embodiment of container
is sized to have an internal volume of about 150 uL or less. Optionally,
another embodiment
of container 10 is sized to have an internal volume of about 200 uL or less.
Optionally, another
embodiment of container 10 is sized to have an internal volume of about 250 uL
or less.
Optionally, another embodiment of container 10 is sized to have an internal
volume of about 300
uL or less. Optionally, another embodiment of container 10 is sized to have an
internal volume
of about 350 uL or less. Optionally, another embodiment of container 10 is
sized to have an
internal volume of about 400 uL or less. Optionally, another embodiment of
container 10 is
sized to have an internal volume of about 450 uL or less. Optionally, another
embodiment of
container 10 is sized to have an internal volume of about 500 uL or less.
Optionally, another
embodiment of container 10 is sized to have an internal volume of about 600 uL
or less.
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100331 Figure IA also shows that the adapter 20, in one embodiment, only
covers a
portion of the sample container 10, such as but not limited to not extending
along an entire length
of the sample container 10. Some embodiments may additionally, or
alternatively, only cover a
portion of the perimeter of the sample container 10. For example, some
embodiments may have
cutouts in the outer peripheral surface of the adapter 20 so that the adapter
20 does not define a
continuous surface around at least a portion of the perimeter of sample
container 10. In such a
non-limiting example, there may be some cost savings, materials saving, or the
like while
substantially allowing the sample container 10 to have an expanded perimeter
or other external
shape to facilitate interaction with another device. Although the sample
container 10 and adapter
20 combination is typically used to engage a channel or cavity of a larger
sample container (not
shown), it should be understood that the sample container 10 and adapter 20
combination can
also be used to engage other devices and is not limited to sample containers.
100341 As seen in Figure 1A, this embodiment of the sample container 10
shows that
some containers 10 may include or be used with a structure with at least one
resealable access
feature, such as but not limited to a pierceable septa, self-sealing port, or
similar structure that
allows for a piercing element to enter but then be able to provide a fluid
tight seal after the
piercing element is removed.
[00351 Referring now to Figure 1B, another embodiment of an adapter 30 for
use with a
sample container 10 will now be described. In this non-limiting example, the
adapter 30 covers
at least a portion of the sample container 10. In one embodiment, the adapter
30 covers only a
portion and not all of the side wall length of the sample container 10. Figure
1B shows that the
adapter 30 has an outer cross-sectional shape that is different from the inner
cross-sectional
shape. In the present non-limiting example, the adapter 30 has an outer cross-
sectional shape
that is square and an inner cross-sectional shape that is circular. Of course,
these shapes are
exemplary and the shapes are not limited to those shown. For example, some
embodiments may
have oval outer cross-sectional shape and a square inner cross-sectional
shape. Other
combinations of shapes are possible and are not excluded. In one non-limiting
example, the
inner cross-sectional shape is configured (such as but not limited to shape
and/or size) to engage
the sample container 10 while the outer cross-sectional shape is configured
(such as but not
limited to shape and/or size) to engage an opening, cavity, or receiving
location of another
device or container. In one embodiment, the outer cross-sectional shape is
configured to one that
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minimizes "rolling" of the container and adapter when they are placed in a
substantially
horizontal configuration on a work surface such as a table. As seen in Figure
1B, the thickness
of the adapter 30 can also be configured to allow for the smaller container 10
to fit in a larger
opening with the adapter 30 acting as a guide to align the container 10 to
engage a needle, tube,
or other connector for the other device. In one embodiment, the guide portion
has a size and
shape closer to the cross-sectional shape of the receiver R in the bulk
container. Optionally, it
may be as long as the container 10. Optionally, it is less than 1/2 of the
length of the container 10.
As seen, the container 10 may have an outer circumference or perimeter outline
smaller than the
outer circumference or perimeter outline of the guide portion.
[00361 Referring now to Figures 2A and 2B, still further embodiments of
adapters 40 and
50 will now be described. Figure 2A shows one non-limiting example of an
adapter 40 for use
with a sample container 10. The sample container 10 may be a cylindrical
vessel that may be
used to contain a sample fluid therein. The adapter 40 in this non-limiting
example may have a
handling feature 42 on a portion of the adapter 40. Optionally, some
embodiments may include a
support feature 44 (shown in phantom) that allows the adapter 40 to self-
standing in a vertical or
substantially vertical configuration. In this non-limiting example, the
support feature 44 may be
a support piece with at least one planar surface and that has a cross-
sectional shape such as but
not limited to rectangular, circular, or other shaped. Similar to the
embodiments of Figures I A
and 1B, the adapter 40 may have different or same inner and outer cross-
sectional shapes.
[00371 Figure 2B shows an embodiment wherein the adapter 50 has a reduced
height
support feature 54. Figure 2B is a cross-sectional view that is configured to
allow easier
visualization of the sample S in the sample container 10. The embodiment of
Figure 23 has a
bottom mounted support feature 54 that enables force application as indicated
by arrow 56. This
may be helpful for facilitating placement and/or movement of the sample
container 10 into an
external device.
[00381 Figures 3A to 3C show still further embodiments of adapters having
different
outer cross-sectional shapes. Figure 3A shows an adapter 60 having a "ridged"
exterior having a
plurality of circular outer cross-sections of different diameters. Figure 3B
shows an adapter 70
with a gear tooth shaped outer cross-section. Figure 313 shows an adapter 80
with a flower
shaped outer cross-section. As seen in these embodiments, the inner cross-
sectional shape
remains one with a circular cross-section to facilitate engagement with a
vessel such as but not
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limited to sample container 10. As seen in Figures 3A to 3C, by having the
outer cross-sectional
shape differ from the inner cross-sectional shape, the shape of the sample
container 10 can be
configured not to limit the type of cavity shape that the container 10 can be
used with. Figures
3A to 3C also show that the adapter can be configured to have at least two
different inner
diameter cavities such as at least a first dimension 90 and at least a second
dimension 92.
100391 Referring now to Figures 4A and 4B, still further embodiments are
shown of a
sample container adapter. in this embodiment of Figure 4A, at least one
portion 110 of the
adapter 100 is shaped, sized, or otherwise configured to match an opening or
cavity in another
device or object. As seem in Figure 4A, other parts 120 of the adapter 100 can
have at least one
of a different shape, a different size, or both. Figure 4A also shows that
this embodiment of
adapter 100 includes at least one open view area 130 that allows a sample
container 10 in the
adapter 100 to be visually observed. This may be helpful in visualizing the
sample level in the
container 10. This may also be helpful in providing a qualitative assessment
of the sample fluid
in the container 10. Adapter 100 can also have an indented grip feature 140
that can facilitate
handling of the adapter 100 by a user, particularly by a gloved user wherein
the manual dexterity
of the user may be reduced. As seen in Figure 4A, the interior 106 of the
adapter 100 can be
shaped to match a contour of the sample container 10 to be placed therein.
[00401 Referring now to Figure 4B, a still further embodiment of a sample
container
adapter will now be described. The embodiment of adapter 150 in Figure 4B is
similar to the
adapter 100 show in Figure 4A. Figure 4B shows that the lower portion 152 is a
flat surface
without an indented surface as seen in the embodiment of Figure 4A. In some
embodiments,
having a flat surface may be simpler to manufacture. A flat surface may also
be easier to clean
or sterilize. Similarly, an interface portion 154 may be sized, shaped, or
otherwise configured to
engage a cavity, opening, or other receiving area in an external device or
container.
100411 Figure 5A shows yet another embodiment similar to that of Figure
4A, except that
this embodiment further shows that one or more surfaces can be shaped to
facilitate user
handling of the adapter 160. In this non-limiting example, at least one
surface 162 is contoured
to accommodate a user's digit. Although not limited to the above, these finger
feature(s) can
facilitate the handling of the adapter, particularly if the adapter is sized
to hold containers smaller
than the typical vacuum container. This non-limiting embodiment also shows
that at least one
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side surface 164 of the adapter 160 can also be shaped such as but not limited
to being
contoured, textured, andlor otherwise configured to facilitate handling by a
user.
100421 Figures 4A, 4B, and 5A also show that at least some embodiments
described
herein, the cross-sectional shape of a first portion the adapter is different
from at least the cross-
sectional shape of a second portion of the adapter. In this manner, a shape
that may be selected
for one purpose, such as but not limited to being a guide into a recess or
cavity, can be combined
with a second shape that may be selected for another purpose, such as but not
limited to
preventing the adapter from rolling when adapter is placed on a surface in
horizontal
configuration. By way of non-limiting example, one embodiment may have a round
cross-
sectional shape that is combined on the adapter to have a second cross-
sectional shape with at
least one flat, substantially flat, and/or concave surface to prevent rolling
when the adapter is in a
lateral orientation.
100431 Figures 5B and 5C show cross-sectional views of at least two other
cross-
sectional shapes 170 and 180 that may be suitable to satisfy the role of anti-
rolling cross-section
by having at least one anti-rolling surface 172 and 182 respectively.
100441 Thermal issue(s) can also be addressed through the use of adapter
such as but not
limited to those shown in the figures herein. The type of sample being
collected can be, but is
not limited to, biological waste fluid. Handling waste fluid can instill some
nausea, negative
feeling, or other negative reaction in some users handling such samples. In
one non-limiting
example, a sample of waste fluid such as urine is typically at a temperature
higher than ambient
temperature. Although this does not usually happen, user handling this sample
may harbor
some less-than-fully positive feeling of having to handle this type of sample.
This less-than-fully
feeling may be amplified when the user can feeling the warmth of the sample
through their skin
or through their gloves by way of direct contact with the wall of the sample
container.
100451 Having the adapter places a thermally insulating barrier between
the user and the
sample container. Due to the lack of direct contact with the walls of the
sample container, the
user is provided a more hygienic sensation when handling such samples. In some
embodiments,
the user can still visually observe the sample in the container, not having to
feel the increased
temperature can mitigate any amplification of a less-than-fully positive
feeling of having to
handle this type of sample.
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100461 it should be understood that although many samples herein use
sample containers
that are separable from the adapter, it should understood that integrally
formed sample containers
and adapters (such as but not limited to being a single piece) are not
excluded and may be
alternative embodiments.
100471 Referring now to Figures 6A to 6B, one embodiment of an external
sample
collector C with a receptor R is shown for receiving a traditional sample
collection tube T. in
this non-limiting example, the sample collection tube T is configured to be
lowered into the
receptor R to withdraw sample from the external sample collector C and the
raised above the
collector C as indicated by arrow 200.
[00481 Figure 6B shows that in at least one embodiment herein, an adapter
such as but
not limited to adapter 40 can be used with a sample container 10 to withdraw
sample from the
external sample collector C. As seen in Figure 6B, the combination of the
sample container 10
and the adapter 40 are lowered and raised as indicated by arrow 202. By way of
non-limiting
example, the sample container 10 may have an initial interior volume under
vacuum conditions,
and this vacuum force draws sample into the container 10 when the container 10
is in fluid
communication with the container C. Optionally, a syringe-type unit or other
force can be used
to draw sample from external sample collector C into the container 10.
[00491 As seen in Figure 6B, the container 10 is significantly smaller
than the traditional
collection tube T. in one embodiment, the container 10 has an internal volume
at least about 10x
smaller than an internal volume of tube T. Optionally, the container 10 has an
internal volume at
least about llx smaller than an internal volume of tube T. Optionally, the
container 10 has an
internal volume at least about 12x smaller than an internal volume of tube T.
Optionally, the
container 10 has an internal volume at least about 13x smaller than an
internal volume of tube T.
Optionally, the container 10 has an internal volume at least about 14x smaller
than an internal
volume of tube T. Optionally, the container 10 has an internal volume at least
about 15x smaller
than an internal volume of tube T. Optionally, the container 10 has an
internal volume at least
about 9x smaller than an internal volume of tube T. Optionally, the container
10 has an internal
volume at least about 8x smaller than an internal volume of tube T.
Optionally, the container 10
has an internal volume at least about 7x smaller than an internal volume of
tube T. Optionally,
the container 10 has an internal volume at least about 6x smaller than an
internal volume of tube
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T. Optionally, the container 10 has an internal volume at least about 5x
smaller than an internal
volume of tube T.
100501 By way of non-limiting example, this reduced size can be beneficial
so that the
container 10 will occupy a smaller height, footprint, or volume when inserted
into a cartridge or
into an external device. In this non-limiting example, the adapter 40 can
adapt the size and/or
shape of the container 10 in at least one dimension to facilitate fitment of
the container 10 in the
receptor R. In Figure 6B, the sample container 10 has a diameter that is
smaller than the
diameter of the receptor R. Figure 6B also shows that the height of the sample
container 10 is
significantly less than that of a traditional collection tube T. In this non-
limiting example, the
adapter 40 can also extend the outer dimension of the sample container 10
along its longitudinal
axis. The opening 11 may be a resealable opening in the sample container 10
can be used to
connect with a tubular structure in the sample collector C or other similar
structure.
100511 Figures 7A and 7B show the sample collection tube T and the sample
container 10
in a lowered position to engage the receptor R. In some embodiments, the
sample collection tube
T and the sample container 10 can be further lowered into receptor R.
Optionally, instead of
using a container 10 that contains a vacuum or reduced pressure atmosphere
therein to pull
sample into the container 10, another embodiment of container 10 may use a
reverse-plunger
design wherein a bottom surface of the container 10 is movable (like a plunger
P) as indicated by
arrow 312. The bottom surface is initially closer to the opening 11 and as the
needle or other
item in container C engages the opening 11, it also pushes the movable bottom
surface of
container 10 as the container is pushed into the receptor R. The movement of
the bottom surface
of container 10 will create suction that will pull sample into the container
10. Optionally, some
embodiments may have a hardened core 310 as shown in Figure 6C that
facilitates engagement
with the needle N or other fluid connector in container C.
100521 Referring now to Figure 8, a still further embodiment is shown
wherein the
sample container 10 (shown removed from the adapter) is configured to be
coupled with a
support assembly such as but not limited to a cartridge 250 as indicated by
arrow 252. In this
non-limiting example, the cartridge 250 may include a plurality of other
vessels, which may each
be in an opening, well, cavity, or other holding location 100. Some
embodiments may position a
tool such as but not limited to a liquid handling tip, pipette tip, and/or
reaction vessel in one of
the locations 100. As seen in Figure 8, a fluid handling apparatus such as but
not limited to a
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pipette P may be used to move fluid from one location 100 to another location
on the cartridge
250 or to a location not on the cartridge 250. Figure 8 also shows that some
embodiments of
cartridge 250 may also include an area 260 that is not in the same plane as
openings for the other
locations 100. Optionally, the area 260 may be at a plane above the plane of
the other locations
100. Optionally, the area 260 may be at a plane below the plane of the other
locations 100.
Optionally, some embodiments may have at least one area above a plane of the
majority of
locations 100 and at least one area below a plane of the majority of locations
100. Some
embodiments may have a touch-off pad or other liquid removing component in
area 260 that
may be used to remove excess liquid from the tip that might impact liquid
transfer accurate if
excess liquid is unintentionally brought along.
100531 As seen in Figure 8, there may also be at least one opening, well,
cavity, or other
holding location 110 that may be sized different to accommodate a sample
container such as but
not limited to a container 10 as described herein. Some embodiments may
include at least one
other sample holding location 120 that may be configured to hold another type
of sample for use
with analysis. By way of non-limiting example, one embodiment may have a urine
sample in
container 10 in location 110 and a blood sample in one or more containers
sized to fit in location
120. Optionally, some embodiments may size and/or shape the opening at
locations 110 and/or
120 to accommodate the container(s) and any holder attached to or integrated
with the
container(s). It should be understood that other embodiments may be sized to
have openings to
accommodate three or more sample containers. In one non-limiting example,
there may be a lid
(not shown for ease of illustration) that covers all, a majority, or portions
of the cartridge 250.
Some embodiment may have a lid with cutouts that expose the locations 110
and/or 120 or any
other sample container location even when the lid is close to facilitate
placement of the sample
container(s) in the locations without having to open the lid which may be
covering reagents or
other vessels. Some embodiments of the cartridge are configured to be inserted
into one or more
analytical or sample processing device(s). It should be understood that in
many embodiments, in
addition to having one or more samples, the cartridge also contains all
reagents that are to be
used to process the one or more samples. Optionally, the cartridge can also
contain all reagents
and handling disposables (pipette tips, cuvettes, etc...) that may be used to
process the one or
more samples.
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100541 While the invention has been described and illustrated with
reference to certain
particular embodiments thereof, those skilled in the art will appreciate that
various adaptations,
changes, modifications, substitutions, deletions, or additions of procedures
and protocols may be
made without departing from the spirit and scope of the invention. For
example, with any of the
above embodiments, it should be understood that some embodiment may have a
rotating fin
device on the holder such as that which may be similar to that of Figure 5A,
wherein the outer
holder may have fins movable from collapsed to extended position. For example,
when inserting
the container into a cartridge, the fin(s) defining the holder can move from
an extended position
(which prevented the container from rolling or falling over) to a collapsed
position to allow for
insertion of the container into a cartridge. In this manner, a device with
foldable, collapsible, or
otherwise reconfigurable structure can be used to provide an expanded
configuration when
outside the cartridge and a reduced-size configuration when in the cartridge.
Although many of
the embodiments herein discuss the sample as a urine sample, it should be
understood that this is
for ease of illustration and that the container is not restricted to that use
and can be configured for
use with other liquid sample(s).
[00551 Additionally, concentrations, amounts, and other numerical data may
be presented
herein in a range format. It is to be understood that such range format is
used merely for
convenience and brevity and should be interpreted flexibly to include not only
the numerical
values explicitly recited as the limits of the range, but also to include all
the individual numerical
values or sub-ranges encompassed within that range as if each numerical value
and sub-range is
explicitly recited. For example, a size range of about 1 nm to about 200 nm
should be interpreted
to include not only the explicitly recited limits of about 1 nm and about 200
nm, but also to
include individual sizes such as 2 nm, 3 nm, 4 nm, and sub-ranges such as 10
mu to 50 nm, 20
urn to 100 nm, etc....
100561 The publications discussed or cited herein are provided solely for
their disclosure
prior to the filing date of the present application. Nothing herein is to be
construed as an
admission that the present invention is not entitled to antedate such
publication by virtue of prior
invention. Further, the dates of publication provided may be different from
the actual publication
dates which may need to be independently confirmed. All publications mentioned
herein are
incorporated herein by reference to disclose and describe the structures
and/or methods in
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connection with which the publications are cited. The following applications
are fully
incorporated herein by reference for all purposes: U.S. Patent Application
Ser. No. 62/011,572.
100571 While preferred embodiments of the present invention have been
shown and
described herein, it will be obvious to those skilled in the art that such
embodiments are provided
by way of example only. Numerous variations, changes, and substitutions will
now occur to
those skilled in the art without departing from the invention. It should be
understood that various
alternatives to the embodiments of the invention described herein may be
employed in practicing
the invention. Any feature, whether preferred or not, may be combined with any
other feature,
whether preferred or not. The appended claims are not to be interpreted as
including means-
plus-function limitations, unless such a limitation is explicitly recited in a
given claim using the
phrase "means for." It should be understood that as used in the description
herein and
throughout the claims that follow, the meaning of "a," "an," and "the"
includes plural reference
unless the context clearly dictates otherwise. For example, a reference to "an
assay" may refer to
a single assay or multiple assays. Also, as used in the description herein and
throughout the
claims that follow, the meaning of "in" includes "in" and "on" unless the
context clearly dictates
otherwise. Finally, as used in the description herein and throughout the
claims that follow, the
meaning of "or" includes both the conjunctive and disjunctive unless the
context expressly
dictates otherwise. Thus, the term "or" includes "and/or" unless the context
expressly dictates
otherwise.
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