Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
PATENT APPLICATION
Attorney Docket IME-2 P('T
LIQUID SAMPLING APPARATUS AND METHOD OF USING SAME
This application claims priority to U.S. Provisional Application Serial No.
60/550,743, filed on March 5, 2004, which is herein incorporated by reference
in
its entirety.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates to sampling liquids, and more particularly, to
an apparatus for sampling a liquid and automatically performing a test.
2. Discussion of Related Art
Sampling methods for liquids typically involve drawing a sampie into a
pipet, syringe, or other container from a cup. Such a sampling method exposes
the sample taker to the liquid. Limiting a sample taker's exposure to a sample
may be desirable, such as in urine analysis. Further, sampling methods may
include exposing the sample to contaminants leading to, for example, sampling
errors.
Therefore, a need exists at least for a system and/or method for reducing
exposure to a sample, reducing sampling errors and limiting contamination of
test
samples.
1
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
SUMMARY OF THE INVENTION
According to an embodiment of the present disclosure, a sampling
apparatus comprises an ampoule barrel for receiving an ampoule through a first
opening, the ampoule barrel comprising a second opening adapted to flow a
liquid into the ampoule barrel and a structure adapted break a frangible tip
of the
ampoule.
The ampoule is a sealed container having a negative pressure therein for
drawing a predetermined volume of liquid into the ampoule, wherein a flow rate
of
the ampoule is less than or equal to a flow rate of the second opening.
The sampling apparatus includes a seal located between an outer surface
of the ampoule and an inner surface of the ampoule barrel. The seal prevents
the
liquid from passing into an upper portion of the ampoule barrel.
The frangible tip is scored to promote a break in the frangible tip in a
predetermined direction. The predetermined direction is substantially
perpendicular to a descent of the ampoule into the ampoule barrel. The
frangible
tip includes a rounded terminus. The frangible tip is offset from a
longitudinal
center of the ampoule.
The sampling apparatus includes a cap for covering the second opening of
the ampoule barrel.
The sampling apparatus includes a carrier, wherein the carrier comprises
a trench receiving an end portion of the ampoule, opposite from the frangible
tip,
and an upper surface supporting the ampoule barrel, wherein a distance between
2
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
a bottom of the trench and the upper surface is adapted to prevent the descent
of
the ampoule into the ampoule barrel.
According to an embodiment of the present disclosure, a method for taking
a liquid sample comprises selecting a test system including an ampoule barrel
and an ampoule comprising a desired reagent, immersing a portion of the
ampoule barrel in a liquid, and breaking the ampoule within the ampoule
barrel,
wherein the ampoule draws the liquid sample.
The method includes extracting the ampoule from the ampoule barrel.
The method includes determining a test result according to the reagent
and liquid sample.
According to an embodiment of the present disclosure, an ampoule barrel
comprises a first opening for receiving an ampoule, a tip, offset from a
longitudinal center of the ampoule barrel, the tip including an elongated
second
opening for flowing a liquid into the ampoule barrel, and an inner surface
effective
for breaking a tip of the ampoule.
The inner surface is disposed at an angle is between about 15 degrees
and about 30 degrees from the longitudinal center of the ampoule barrel. The
inner surface is a convex radius relative to an interior of the ampoule
barrel.
The ampoule barrel includes at least a third opening on a sidewall of the
ampoule barrel for flowing the liquid into the ampoule barrel.
The ampoule barrel includes a flange at an end portion, opposite the tip.
3
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
BRIEF DESCRIPTION OF THE DRAWINGS
Preferred embodiments of the present invention will be described below in
more detail, with reference to the accompanying drawings:
Figures 1 A-C are an illustration of a test system according to an
embodiment of the present disclosure;
Figure 2 is a cross-section view of the test system of Figure 1;
Figure 3 is a cross-section view of a tip area of the test system of Figure 1;
Figures 4A-C are illustrations of a sampling cap, sheath and ampoule
according to an embodiment of the present disclosure;
Figures 5A-D are illustrations of an ampoule barrel having no offset
according to an embodiment of the present disclosure;
Figures 6A-D are illustrations of an ampoule barrel having an offset
according to an embodiment of the present disclosure;
Figures 7A-D are illustrations of an ampoule barrel having an offset
according to an embodiment of the present disclosure;
Figures 8A-C are illustrations of a carrier for a test system according to an
embodiment of the present disclosure;
Figures 9A-C are illustrations of a breaking mechanism according to an
embodiment of the present disclosure; and
Figure 10 is a flow chart of a method according to an embodiment of the
present disclosure.
4
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
A test system according to an embodiment of the present disclosure is a
self-contained total microbe test. Referring to Figure 1 A, a test system 100
includes an ampoule barrel 101, an ampoule 102 and a cap 103. The ampoule
102 may be removed from the ampoule barrel 101.
Referring to Figure 1 B, the ampoule 102 includes a frangible tip 104. The
frangible tip 104 may be offset from a center of a main body 105 of the
ampoule
102. The ampoule 102 is a sealed container, which is opened open breaking the
frangible tip 104. The interior of the ampoule 102 is a vacuum-sealed
environment. Upon breaking the tip 104, the ampoule 102 is adapted to draw a
predetermined volume of liquid according to an internal pressure of the
ampoule
102.
Referring to Figure 1 C, the ampoule barrel 101 includes an opening 106
for receiving an ampoule. The ampoule barrel 101 includes a tip 107 for
allowing
a liquid into the ampoule barrel 101. The barrel tip 107 includes one or more
ports for drawing the liquid into the ampoule barrel 101 under the vacuum of
an
ampoule. The tip 107 of the ampoule barrel may be off center relative to a
longitudinal center of the ampoule barrel 101. An off center tip 107 may be
inserted into a sampling cup, wherein the sampling cup may be held on edge to
pool a sample, increasing a depth of the sample. The off center tip 107 may be
immersed in the pooled sample.
5
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
Figure 2 is a cross-section view of a test system 100. An ampoule barrel
101 receives an ampoule 102. A seal 201, formed of for example, a rubber
substance secures the ampoule 102. A tip 104 of the ampoule 102 projects
through the seal 201 and into a sample chamber. Upon placing the barrel tip
107
in a liquid, the sea1201 prevents the liquid from passing into an upper
portion of
the ampoule barrel 101. The cap 103 is removable. The cap 103 prevents
contaminants from entering the ampoule barrel 101 or contacting the barrel tip
107 prior to a test.
Referring to Figure 3, the ampoule barrel 101 includes ports, e.g., 301 and
302, for allowing a liquid to pass into a lower portion or sample chamber 303
of
the ampoule barrel 101. The ports may be located on an end, e.g., 301, of the
ampoule barrel 101 and/or on a side of the ampoule barrel, e.g., 302. The seal
201 prevents the liquid form passing into an upper portion of the ampoule
barrel
101. The ampoule 102 includes a frangible tip 104. The tip 104 includes a
terminus 305. The terminus 305 has a rounded structure. Above the terminus
305, a score 306 is provided on a portion of the tip 104. The score 306 is
located
to control the height at which the tip 104 breaks. The score 306 may be
located
on a portion, e.g., about 90 degrees or about 180 degrees, of the
circumference
of the tip 104. For example, as shown in Figure 3, the score 306 is located on
a
portion of the tip 104 away from the direction of the intended breakage. The
ampoule 102 may be depressed into the ampoule barrel 101, wherein the
terminus 305 meets an angled face 304 of the ampoule barrel 101. A pressure
6
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
applied to the ampoule 102 causes the ampoule to descend into the ampoule
barrel 101 with the seal 201. The angled face 304 converts the pressure into a
lateral pressure on the terminus 305 of the tip 104. The tip 104 breaks at
about
the height of the score 306 under the lateral pressure. The terminus 305
breaks
away from the tip 104 allowing the liquid in the lower portion 303 of the
ampoule
barrel 101 into the ampoule 102. A flow rate at which the ampoule 102 draws
liquid may be slower than a flow rate of the ports of the ampoule barrel 101.
The
tip 104 may be sheathed, such that upon breaking the terminus 305, a lower
portion of the tip drop away into the ampoule barrel 101 and a remaining
portion
of the tip 104 is guarded within the sheath.
Referring to Figures 4A-C, upon drawing a sample into the ampoule 102 a
sampling cap 401 may be placed over a broken tip of the ampoule 102. A sheath
402 guards any sharps. The sampling cap 401 includes a nipple 403. The nipple
403 fits within the sheath 402. The cap 401 reduces a potential for contact
with
the liquid in the ampoule 102. The nipple 403 cooperates with the sheath 402,
securing the sampling cap 401 to the ampoule 102. The nipple 403 may be a
tube through which a syringe 404 or other device may gain access to the
contents of the ampoule 102.
Referring to Figures 5-7, various ampoule barrels are depicted. It should
be noted that modifications and variations of the ampoule barrels are
contempiated herein.
Referring to Figures 5A-D, ampoule barrels 101 having a bottom port 501
7
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
with no offset relative to a centerline of the ampoule barrel 101 are shown.
Referring to Figure 5A, a lead in angle 502 of the face 304 is -about 60
degrees.
The ampoule 102 includes an offset tip 104. The tip 104 is guarded by a sheath
402. The offset tip 104 is aligned to meet the face 304 as the ampoule 102
descends into the ampoule barrel 101. Figure 5B illustrates an ampoule barrel
101 having a face 304 with a lead in angle of about 30 degrees. Figures 5C and
5D illustrate ampoule barrels 101 having a face 304. The face 304 has a
radius.
For example, the radius of the face 304 in Figure 5C is about 0.500 inches and
the radius of the face 304 in Figure 5D is about 0.110 inches. The radius of
the
face 304 converts the descent of the ampoule 102 into a lateral force that
breaks
the tip 104.
Referring to Figures 6A-D, a bottom port 501 of the ampoule barrel 101 is
offset, for example, by 0.065 inches from a centerline of the ampoule barrel
101.
Referring to Figure 6A, a lead in angle 502 of the face 304 is about 30
degrees. A
height of the face is not uniform around the ampoule barrel 101. The rotation
of
the ampoule 102 within the ampoule barrel 101 ensures that the tip 104
contacts
the face 304 upon descending into the ampoule barrel 101' The rotation may be
adjusted manually. A mechanism, such as a cooperating shape of the ampoule
barrel 101 and ampoule 102, may secure an alignment. A sheath 402 may be
implemented as a guard over the tip 104. Referring to Figure 6B, a lead in
angle
of the face 304 is about 60 degrees. Referring to Figures 6C and 6D a face 304
has a radius of about 0.500 inches and 0.250 inches, respectively.
8
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
Referring to Figures 7A-D, a bottom port 501 of the ampoule barrel 101 is
offset, for example, by 0.130 inches from a centerline of the ampoule barrel
101.
Referring to Figure 7A, a lead in angle 502 of the face 304 is about 30
degrees.
The angle of the face varies around the circumference of the ampoule barrel
101
between about 90 degrees and about 75 degrees. A height of the face is not
uniform around the ampoule barrel 101. The rotation of the ampoule 102 within
the ampoule barrel 101 ensures that the tip 104 contacts the face 304 upon
descending into the ampoule barrel 101. Referring to Figure 7B, a lead in
angle
of the face 304 is about 60 degrees. Referring to Figures 7C and 7D a face 304
has a radius of about 0.500 inches and 0.250 inches, respectively. A sheath
402
may be implemented as a guard over the tip 104.
Referring to Figures 8A-C, a test system 100 may be loaded into a carrier
801. The carrier 801 may be capped by a top 802. The carrier comprises one or
more trenches 804 for receiving a portion of an ampoule 102. The trench 804
has
a depth adapted to support an unused system 100 such that the ampoule 102 is
not pressed into the ampoule barrel 101; a distance between a bottom of the
trench and the upper surface 805 prevents the descent of the ampoule into the
ampoule barrel. A flange 803 of the ampoule barrel 101 rests on an upper
surface of the carrier 801.
An ampoule 102 according to an embodiment of the present disclosure is
a sterile vacuum packaging ampoule containing a dry, non-hazardous, test
reagent system. The ampoule 102 prevents user contamination or hazard, has
9
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
about a 4-year product shelf life, does not trigger transportation
restrictions and
does not need climate-controlled storage.
A test of a liquid may be performed using a test system 100 according to
an embodiment of the present disclosure. A sample module or ampoule barrel
101 secures a test ampoule 102 for extracting a liquid sample. The ampoule
barrel 101 limits a sample taker's exposure to the liquid. When used with a
pre-
dosed test ampoule 102, the ampoule barrel 101 and test ampoule 102
automatically start a test of the sampled liquid under the pressure of the
vacuum.
Referring to Figure 9A, the sampie chamber 303 houses an ampoule tip
breaker assembly 900. The ports or inlets, e.g., 301 and 302, may be formed on
the walls of the ampoule barrel 101 and at a tip of the ampoule barrel 101.
Any
number of inlets may be used. The inlets allow the sample to freely enter the
sample chamber at a rate at least as great as the sample enters the ampoule
102. Thus, the sample may enter the ampoule 102 in a predetermined dose,
substantially unaffected by suction or fluid resistance. The ampoule tip
breaker
assembly 900 is stabilized in the sample chamber 303 to receive a tip 104 of
the
ampoule 102.
Referring to Figures 9B and 9C, the ampoule tip breaker assembly 900 is
formed such that the sample may flow around the assembly and enter the
ampoule 102. The ampoule tip breaker assembly 900 includes a surface
disposed at an angle for breaking the frangible portion of the test ampoule.
The
surface may be a hollow tube 901 for receiving a tip 104 of an ampoule 102 and
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
for breaking the tip 104. The hollow tube 901 is disposed at an angle to apply
a
substantially lateral force against the tip to facilitate the breaking of the
tip. 104
For example, the hollow tube may be disposed at about 45 degrees from the
walls of the sample chamber. The assembly 900 includes a stabilizer support
902
disposed at an angle for supporting the hollow tube 901, e.g., at about 90
degrees from the angle of the hollow tube 901. The stabilizer support 302 and
the
hollow tube 901 'may be formed as one piece. The hollow tube 901 may collect a
broken portion of the tip of the ampoule 102 upon breaking away from the
ampoule 102.
The stabilized ampoule tip breaker 900 breaks the tip of the ampoule 102
upon the application of pressure to the ampoule 102, forcing the test ampoule
tip
104 to engage a surface disposed at an angle. The tip 104 of the ampoule 102
is
submerged in liquid as to avoid suction entrained air and creating an
unacceptable ampoule fill.
The test ampoule may be a hard-surfaced, self-filling container. The test
ampoule includes mixed test indicators/media in predetermined quantities for
performing a complete microbiological test. The test ampoules may be sealed,
having a vacuum of about 20-30 inches of mercury or more. The test ampoule
and contents may be insensitivity to storage conditions and may have a shelf
life
of about 4 years or more. The test ampoule includes a frangible area that can
be
broken, allowing a predetermined amount of sample to enter the test ampoule
and be exposed to the test indicators/media.
11
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
The test ampoule may be an ampoule as described in U.S. Patent
Numbers 5,159,799 entitled VIAL WITH POWDERED REAGENT, 5,550,032
entitled BIOLOGICAL ASSAY FOR MICROBIAL CONTAMINATION, and
5,935,799 entitled BIOLOGICAL ASSAY FOR MICROBIAL CONTAMINATION,
each patent being incorporated herein by reference in the entirety.
A test ampoule may be a pre-dosed, hermetically sealed, vacuum
ampoule. The vacuum packaging of test ampoule preserves the reagent/media
for years and needs no special storage conditions such as refrigeration. When
the test is started, a aqueous sample of a predetermined volume, e.g., 7.5 ml,
is
automatically drawn into the test ampoule. The volume of sample drawn can be
any predetermiried amount, depending on, for example, the size of the test
ampoule and the strength of the vacuum. The test may be concluded when the
test ampoule turns a predetermined color, e.g., orange or red. The elapsed
time
from test start to test end determines the level of microbial contamination.
Test
results may come as fast as one (1) hour for concentrations of 201 or twelve
(12)
hours for 10' microbial concentrations. The test ampoule may be used as
presence/absence test at 24 hours. A Triphenyltetrazoliumchloride (TTC)
indicator may react to aerobic microbial activity in the sample to include
facultative species. Fungi may also be detected. =The presence of fungi may be
indicated by floating red particles after 24 hours. Time/Concentration
calibrations
are based upon mixed microbial populations typically found in industrial and
natural waters. Waters dominated by a particular species may use a one-time
12
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
calibration adjustment. Each test ampoule comes complete with a
sample/ampoule, snapping cup, dechlorinating solution, sample identification
labels, waste-water instructions and a resultsAnstruction chart. Test
incubation
temperature can be controlled, and may be set to, for example, 95 F or room
temperature. Test incubation can be performed manually by purchasing a
reusable carry incubation tube or using a standard laboratory heat block or
oven.
Automatic incubation and end of test detection can accomplished using an
incubator/auto-analyzer. Factory-prepared test calibrations/formulations
and/or
private labeling may also to used.
An insulated chamber, such as an autoincubation chamber, suitable to
hold a plurality of test ampoules at a controlled temperature and for specific
time
initiates and maintains an incubation temperature for a period of time and may
return to refrigeration. This chamber may be transportable for all operational
phases of the test (refrigeration to incubation back to refrigeration). The
test
ampoule, sample module, and insulated chamber may be pre-assembled into a
clean or sterilized product that is operated by the sample technician or test
initiator.
Referring to Figure 10, an ampoule for a desired test is selected 1000. The
ampoule is piaced in an ampoule barrel. The ampoule barrel is at
least,partially
immersed in a liquid sample, and the tip of the ampoule is broken to begin a
test
1001. The ampoule containing a sample is extracted from the sample module
1002. A cap may be placed over the broken tip of the test ampoule. The cap may
13
CA 02610629 2006-08-30
WO 2005/086816 PCT/US2005/007605
include, for example, a bar code for tracking and/or a color chart for
determining
results. The test ampoule may be placed in an autoincubation testing chamber
1003. The autoincubation testing chamber may be designed for shipping to a
laboratory or other location, wherein the autoincubation testing chamber may
be
coupled to a power source. A control device of the autoincubation testing
chamber controls a temperature profile (e.g., heating or cooling of samples
under
test). The control device may include a processor for outputting control
signals to
a heater or chiller, and memory device for storing, for example, temperature
and
time settings. The results may be checked at a predetermined end time 1004.
The timing shown in Figure 10 are provide as examples, actual times may differ
depending on the test and procedures.
Having described embodiments for apparatus and method for sampling a
liquid, it is noted that modifications and variations can be made by persons
skilled in the art in light of the above teachings. It is therefore to be
understood
that changes may be made in the particular embodiments of the invention
disclosed which are within the scope and spirit of the invention as defined by
the
appended claims. Having thus described the invention with the details and
particularity required by the patent laws, what is claimed and desired
protected
by Letters Patent is set forth in the appended claims.
14
