Classifications

• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/02—Devices for withdrawing samples
  • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
  • A61B10/0045—Devices for taking samples of body liquids
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
  • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
  • B01L3/508—Containers for the purpose of retaining a material to be analysed, e.g. test tubes rigid containers not provided for above
  • B01L3/5082—Test tubes per se
  • B01L3/50825—Closing or opening means, corks, bungs
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/02—Devices for withdrawing samples
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/02—Devices for withdrawing samples
  • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
  • G01N1/14—Suction devices, e.g. pumps; Ejector devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
  • A61B2017/00561—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated creating a vacuum
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
  • A61B90/03—Automatic limiting or abutting means, e.g. for safety
  • A61B2090/037—Automatic limiting or abutting means, e.g. for safety with a frangible part, e.g. by reduced diameter
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2200/00—Solutions for specific problems relating to chemical or physical laboratory apparatus
  • B01L2200/06—Fluid handling related problems
  • B01L2200/0642—Filling fluids into wells by specific techniques
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/04—Closures and closing means
  • B01L2300/041—Connecting closures to device or container
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2300/00—Additional constructional details
  • B01L2300/08—Geometry, shape and general structure
  • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
  • B01L2300/0835—Ampoules
• • B—PERFORMING OPERATIONS; TRANSPORTING
  • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
  • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
  • B01L2400/00—Moving or stopping fluids
  • B01L2400/06—Valves, specific forms thereof
  • B01L2400/0677—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers
  • B01L2400/0683—Valves, specific forms thereof phase change valves; Meltable, freezing, dissolvable plugs; Destructible barriers mechanically breaking a wall or membrane within a channel or chamber
• • G—PHYSICS
  • G01—MEASURING; TESTING
  • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
  • G01N1/00—Sampling; Preparing specimens for investigation
  • G01N1/02—Devices for withdrawing samples
  • G01N1/10—Devices for withdrawing samples in the liquid or fluent state
  • G01N1/14—Suction devices, e.g. pumps; Ejector devices
  • G01N2001/1418—Depression, aspiration

Definitions

• the present invention relates to sampling liquids, and more particularly, to an apparatus for sampling a liquid and automatically performing a test.
• sampling methods 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
• apparatus comprises an ampoule barrel for receiving an ampoule through a first
• 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
• the ampoule is a sealed container having a negative pressure therein for
• the sampling apparatus includes a seal located between an outer surface
• 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
• 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 liquid sample comprises selecting a test system including an ampoule barrel and an ampoule comprising a desired reagent, immersing a portion of the
• the method includes extracting the ampoule from the ampoule barrel.
• the method includes determining a test result according to the reagent
• an ampoule barrel comprises a first opening for receiving an ampoule, a tip, offset from a
• 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
• 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.
• Figures 1 A-C are an illustration of a test system according to an
• 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 ;
• FIGS. 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
• 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
• Figure 10 is a flow chart of a method according to an embodiment of the
• test system is a test system according to an embodiment of the present disclosure.
• test system 100 a test system 100
• the ampoule 102 includes an ampoule barrel 101 , an ampoule 102 and a cap 103.
• the ampoule 102 may be removed from the ampoule barrel 101.
• the ampoule 102 includes a frangible tip 104.
• frangible tip 104 may be offset from a center of a main body 105 of the ampoule
• 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
• 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
• 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
• sampling cup may be held on edge to
• the off center tip 107 may be
• FIG 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
• a tip 104 of the ampoule 102 projects through the seal 201 and into a sample chamber. Upon placing the barrel tip 107
• the seal 201 prevents the liquid from passing into an upper portion of
• 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.
• 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
• 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
• the terminus 305 has a rounded structure.
• 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
• the score 306 is located on a portion, e.g., about 90 degrees or about 180 degrees, of the circumference of the tip 104.
• the score 306 is located on a portion, e.g., about 90 degrees or about 180 degrees, of the circumference of the tip 104.
• the score 306 is located on a portion, e.g., about 90 degrees or about 180 degrees, of the circumference of the tip 104.
• the score 306 is located on a portion, e.g., about 90 degrees or about 180 degrees, of the circumference of the tip 104.
• 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 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
• the tip 104 breaks at about
• 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
• sampling cap 401 may be placed over a broken tip of the ampoule 102.
• the sampling cap 401 includes a nipple 403.
• the nipple is a nipple 403.
• the cap 401 fits within the sheath 402.
• the cap 401 reduces a potential for contact with
• the nipple 403 cooperates with the sheath 402, securing the sampling cap 401 to the ampoule 102.
• the nipple 403 may be a
• ampoule barrels 101 having a bottom port 501 with no offset relative to a centerline of the ampoule barrel 101 are shown.
• 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
• Figures 5C and 5D illustrate ampoule barrels 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.
• 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.
• 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.
• a lead in angle 502 of the face 304 is about 30 degrees.
• a mechanism such as a cooperating shape of the ampoule
• a sheath 402 may be
• a bottom port 501 of the ampoule barrel 101 is
• 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
• a height of the face is not uniform around the ampoule barrel 101. The rotation of the ampoule 102 within
• 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
• 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
• the ampoule 102 prevents user contamination or hazard, has about a 4-year product shelf life, does not trigger transportation restrictions and
• a test of a liquid may be performed using a test system 100 according to
• the ampoule 101 secures a test ampoule 102 for extracting a liquid sample.
• the ampoule 101 secures a test ampoule 102 for extracting a liquid sample.
• the barrel 101 limits a sample taker's exposure to the liquid.
• the ampoule barrel 101 and test ampoule 102 automatically start a test of the sampled liquid under the pressure of the vacuum.
• the sample 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 may be any number of inlets.
• 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.
• the sample may enter the ampoule 102 in a predetermined dose
• the ampoule tip breaker assembly 900 is stabilized in the sample chamber 303 to receive a tip 104 of the
• the ampoule tip breaker assembly 900 is formed such that the sample may flow around the assembly and enter the
• the ampoule tip breaker assembly 900 includes a surface
• the surface may be a hollow tube 901 for receiving a tip 104 of an ampoule 102 and for breaking the tip 104.
• the hollow tube 901 is disposed at an angle to apply a
• the hollow tube may be disposed at about 45 degrees from the
• the assembly 900 includes a stabilizer support 902 disposed at an angle for supporting the hollow tube 901 , e.g., at about 90
• 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
• 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
• test ampoules may be sealed, having a vacuum of about 20-30 inches of mercury or more.
• test ampoule includes a frangible area that can be
• test ampoule may be an ampoule as described in U.S. Patent Numbers 5,159,799 entitled VIAL WITH POWDERED REAGENT, 5,550,032
• BIOLOGICAL ASSAY FOR MICROBIAL CONTAMINATION entitled BIOLOGICAL ASSAY FOR MICROBIAL CONTAMINATION, and 5,935,799 entitled BIOLOGICAL ASSAY FOR MICROBIAL CONTAMINATION,
• 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.
• a aqueous sample of a predetermined volume e.g., 7.5 ml
• 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
• Test results may come as fast as one (1 ) hour for concentrations of 201 or twelve (12) hours for 10 1 microbial concentrations.
• the test ampoule may be used as
• TTC Triphenyltetrazoliumchloride
• 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
• Test incubation temperature can be controlled, and may be set to, for example, 95°F or room
• 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.
• test ampoules 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).
• 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
• an ampoule for a desired test is selected 1000.
• ampoule is placed in an ampoule barrel.
• the ampoule barrel is at least partially
• the ampoule containing a sample is extracted from the sample module
• a cap may be placed over the broken tip of the test ampoule.
• the cap may include, for example, a bar code for tracking and/or a color chart for determining
• test ampoule may be placed in an autoincubation testing chamber
• the autoincubation testing chamber may be designed for shipping to a laboratory or other location, wherein the autoincubation testing chamber may be
• 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
• 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

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Chemical & Material Sciences (AREA)
• General Health & Medical Sciences (AREA)
• Pathology (AREA)
• Analytical Chemistry (AREA)
• Hematology (AREA)
• Immunology (AREA)
• General Physics & Mathematics (AREA)
• Biochemistry (AREA)
• Physics & Mathematics (AREA)
• Hydrology & Water Resources (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• Animal Behavior & Ethology (AREA)
• Clinical Laboratory Science (AREA)
• Chemical Kinetics & Catalysis (AREA)
• Surgery (AREA)
• Molecular Biology (AREA)
• Medical Informatics (AREA)
• Biomedical Technology (AREA)
• Engineering & Computer Science (AREA)
• Sampling And Sample Adjustment (AREA)
• Automatic Analysis And Handling Materials Therefor (AREA)

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• 2005
  • 2005-03-07 RU RU2006135014/04A patent/RU2006135014A/ru not_active Application Discontinuation
  • 2005-03-07 US US11/074,466 patent/US20050209531A1/en not_active Abandoned
  • 2005-03-07 AU AU2005220891A patent/AU2005220891A1/en not_active Abandoned
  • 2005-03-07 JP JP2007502112A patent/JP2007527998A/ja active Pending
  • 2005-03-07 WO PCT/US2005/007605 patent/WO2005086816A2/en active Application Filing
  • 2005-03-07 BR BRPI0508120-3A patent/BRPI0508120A/pt not_active IP Right Cessation
  • 2005-03-07 CA CA002610629A patent/CA2610629A1/en not_active Abandoned
  • 2005-03-07 EP EP05725009A patent/EP1749421A4/en not_active Withdrawn
  • 2005-03-07 KR KR1020067020499A patent/KR20060135015A/ko not_active Application Discontinuation
• 2006
  • 2006-08-31 IL IL177835A patent/IL177835A/en not_active IP Right Cessation
  • 2006-09-20 ZA ZA200607870A patent/ZA200607870B/xx unknown
  • 2006-10-02 NO NO20064455A patent/NO20064455L/no not_active Application Discontinuation

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