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WO2024250069A1 - Dispositif de diagnostic et procédé d'utilisation - Google Patents

Dispositif de diagnostic et procédé d'utilisation Download PDF

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Publication number
WO2024250069A1
WO2024250069A1 PCT/AU2024/050598 AU2024050598W WO2024250069A1 WO 2024250069 A1 WO2024250069 A1 WO 2024250069A1 AU 2024050598 W AU2024050598 W AU 2024050598W WO 2024250069 A1 WO2024250069 A1 WO 2024250069A1
Authority
WO
WIPO (PCT)
Prior art keywords
container
upper portion
cap
diagnostic device
liquid sample
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/AU2024/050598
Other languages
English (en)
Inventor
Allan Chisholm
Shane O’NEILL
Marc Veenendaal
Michelle Garcia
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ath Australia Ltd
Original Assignee
Ath Australia Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from AU2023901816A external-priority patent/AU2023901816A0/en
Application filed by Ath Australia Ltd filed Critical Ath Australia Ltd
Priority to AU2024284065A priority Critical patent/AU2024284065A1/en
Publication of WO2024250069A1 publication Critical patent/WO2024250069A1/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • 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
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • 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
    • B01L3/505—Containers for the purpose of retaining a material to be analysed, e.g. test tubes flexible containers not provided for above
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed
    • 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
    • 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
    • B01L3/52—Containers specially adapted for storing or dispensing a reagent
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
    • G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
    • G01J3/02—Details
    • G01J3/0267—Sample holders for colorimetry
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N21/78—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator producing a change of colour
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6803—General methods of protein analysis not limited to specific proteins or families of proteins
    • G01N33/6806—Determination of free amino acids
    • G01N33/6812—Assays for specific amino acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B10/007—Devices for taking samples of body liquids for taking urine samples
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B2010/0003—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements including means for analysis by an unskilled person
    • A61B2010/0006—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements including means for analysis by an unskilled person involving a colour change
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
    • A61J1/06—Ampoules or carpules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1412—Containers with closing means, e.g. caps
    • A61J1/1418—Threaded type
    • 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
    • B01L2200/14—Process control and prevention of errors
    • B01L2200/141—Preventing contamination, tampering
    • 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
    • B01L2200/16—Reagents, handling or storing thereof
    • 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
    • B01L2300/042—Caps; Plugs
    • 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
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/0609—Holders integrated in container to position an object
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01J—MEASUREMENT OF INTENSITY, VELOCITY, SPECTRAL CONTENT, POLARISATION, PHASE OR PULSE CHARACTERISTICS OF INFRARED, VISIBLE OR ULTRAVIOLET LIGHT; COLORIMETRY; RADIATION PYROMETRY
    • G01J3/00—Spectrometry; Spectrophotometry; Monochromators; Measuring colours
    • G01J3/46—Measurement of colour; Colour measuring devices, e.g. colorimeters
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/17—Systems in which incident light is modified in accordance with the properties of the material investigated
    • G01N21/25—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands
    • G01N21/29—Colour; Spectral properties, i.e. comparison of effect of material on the light at two or more different wavelengths or wavelength bands using visual detection

Definitions

  • diagnostic devices for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient. Also described herein are methods for indicating the presence of a species indicative of a disease using the diagnostic device.
  • Millon’s Reagent contains mercury, however, it needs to be very carefully handled.
  • Millon’s Reagent was used in a glass ampoule with a frangible portion. Immediately before use, the ampoule was broken and a urine sample mixed with the Millon’s Reagent. However, the broken glass ampoule has sharp edges and presents a health hazard, and there is a risk that the user may be exposed to mercury (e.g. due to spillage). Furthermore, if the ampoule is not broken with a good sharp knock, it may shatter. For at least these reasons, existing tests involving Millon’s Reagent are not really suitable for non-specialised use.
  • a non-flowing carrier such as a gel carrier or an absorbent material.
  • a liquid sample from a patient e.g. a urine sample
  • the non-flowing carrier quickly disintegrates, thus enabling rapid and complete mixing of the fluid sample and mercury-containing reagent.
  • the Millon’s Reagent (or other acidic and mercury-containing reagents) may be provided in a test cell of the device and covered with a film of polymeric material.
  • a fluid sample having a different pH e.g. a urine sample
  • the film quickly disintegrates, thus again enabling rapid and complete mixing of the fluid sample and mercury-containing reagent.
  • test devices While such test devices are effective and have been successfully used to detect abnormal cell activity in many patients, stability issues can occur if the gel carrier or polymeric material are, contrary to their storage instructions, allowed to heat up too much, or if they are stored for particularly long periods of time.
  • a diagnostic device for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient (e.g. a urine sample).
  • the device comprises: a container configured to receive the liquid sample, the container comprising an upper portion, a lower portion and a weakened portion therebetween; the upper portion comprising an opening configured to receive the liquid sample, and the lower portion being in fluid communication with the upper portion and configured to receive therein an ampoule containing a reagent which, when contacted with the liquid sample, colorimetrically indicates whether the liquid sample contains the species; and a cap for sealing the container, the cap being configured for receipt at the opening of the upper portion and which, upon attachment thereto, cannot be detached, wherein, in use, bending of the container at the weakened portion breaks open the ampoule, whereupon the liquid sample and the reagent can mix and a colour of the resultant mixture is visible through a transparent portion (e.g. a transparent wall or walls) of the
  • the diagnostic device of the present invention provides a reliable test kit that can be used by a patient themselves, potentially in the comfort of their own home, and without any need for specialised medical training.
  • the diagnostic device also provides for the safe containment of toxic (or otherwise hazardous) liquid reagents required to produce the colorimetric result, such as mercury-containing reagents and biohazardous waste, (e.g. blood, urine or the like), due to it not being reopenable after the cap is attached.
  • the diagnostic device overcomes stability problems associated with mercury-containing reagents, such as those described above, because ampoules do not degrade upon prolonged storage or when exposed to extremes of temperature.
  • the species indicative of a disease may be an amino acid such as tyrosine (or its metabolites) and the disease a cancer (e.g. colorectal cancer).
  • the liquid sample may be a urine sample.
  • the reagent may be a mercury-containing liquid acid reagent, such as that described in international (PCT) application no. PCT/AU2016/050067, the contents of which are incorporated herein in their entirety.
  • the cap may comprise one or more engagement elements configured to engage with corresponding elements on the upper portion, whereby such engagement prevents detachment of the cap after attachment to the container.
  • the corresponding elements on the upper portion may comprise one or more projections extending outwardly from a periphery of the upper portion, wherein, when the cap is attached to the upper portion, the one or more projections irreversibly engage with the one or more engagement elements of the cap.
  • the one or more projections extending outwardly from the periphery of the upper portion may define a pawl and the engagement elements of the cap may define a ratchet.
  • the engagement elements may be located on an inner wall of the cap.
  • the upper portion of the container and the cap may comprise complementary screw-threaded portions.
  • the cap may comprise one or more transparent portions.
  • the lower portion may comprise one or more tabs extending outwardly from the lower portion.
  • the one or more tabs may, for example, comprise a colour chart, whereby the colour of the resultant mixture can be compared to the colour chart to determine whether the sample contains the species.
  • the upper portion may comprise a dividing wall, whereby one side of the dividing wall is in fluid communication with the lower portion and the other side of the dividing wall is in fluid communication with an overflow chamber.
  • the dividing wall may be circular/annular in shape, with the overflow chamber being formed between the dividing wall and an outer wall of the upper portion.
  • a height of the dividing wall may correspond to a predefined volume of the liquid sample.
  • the upper portion may comprise one or more baffles.
  • the reagent may be a toxic liquid reagent.
  • the reagent may be a liquid acidic reagent.
  • the reagent may be a mercury-containing reagent.
  • the method comprises the steps of:
  • a diagnostic device comprising: a container configured to receive the liquid sample, the container comprising an upper portion, a lower portion and a weakened portion therebetween; the upper portion comprising an opening configured to receive the liquid sample and being in fluid communication with the lower portion, wherein the lower portion houses an ampoule that contains a reagent which, when contacted with the liquid sample, colorimetrically indicates whether the liquid sample contains the species; and a cap for sealing the container, the cap being configured for receipt at the opening of the upper portion, and which upon attachment thereto, cannot be detached,
  • viewing the colour of the resultant mixture through the transparent walls of the container may further comprise comparing the colour of the resultant mixture with a colour chart (e.g. a chart supplied on or otherwise associated with the diagnostic device).
  • a colour chart e.g. a chart supplied on or otherwise associated with the diagnostic device.
  • a cap for a container of a diagnostic device for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient comprising: a body capable of covering an opening of the container, the body having an upper wall and a tubular skirt extending downwardly from the upper wall, and one or more engagement elements located on an inner wall of the cap, wherein, when the cap is received on the container, the one or more engagement elements are configured to engage with corresponding elements on the container, whereby such engagement prevents detachment of the cap after attachment to the container.
  • the cap and the outer surface of the container may comprise complementary screw-threaded portions.
  • the cap may comprise one or more transparent portions.
  • the transparent portions may, for example, be located on the tubular skirt.
  • the cap configured to close the open upper end of the container according to the first aspect is the cap according to the third aspect.
  • Figure 1 shows an isometric view of a container for a diagnostic device in accordance with an embodiment of the present invention.
  • Figure 2 shows a front and a sectional view of the container of Figure 1 , with Figure 2(a) showing a front view and Figure 2(b) showing a sectional view along the line A-A through the container of Figure 2(a).
  • Figure 3 shows a side and a sectional view of the container of Figure 1 , with Figure 3(a) showing a side view and Figure 3(b) showing a sectional view along the line B-B through the container of Figure 3(a).
  • Figure 4 shows a top isometric view of an embodiment of a cap for a container such as that shown in Figure 1 .
  • Figure 5 shows a bottom isometric view of the cap of Figure 4.
  • Figure 6 shows a front view of a diagnostic device including the container of Figure 1 and the cap of Figure 4 in a closed configuration.
  • Figure 7 shows a sectional view along the line A-A through the container shown in Figure 6.
  • Figure 8 shows a sectional view along the line B-B through the diagnostic device shown in Figure 6.
  • Figure 9 shows steps of a method for colorimetrically indicating the presence of a species indicative of a disease.
  • the invention provides a diagnostic device for colorimetrically indicating the presence of a species indicative of a disease in a liquid sample from a patient and, in another aspect, a method for detecting this species using such a diagnostic device.
  • the diagnostic device includes a container configured to receive the patient’s liquid sample, where the container comprises an upper portion, a lower portion and a weakened portion therebetween.
  • the upper portion comprises an opening configured to receive the liquid sample.
  • the lower portion is in fluid communication with the upper portion and is configured to receive therein an ampoule containing a reagent which, when contacted with the patient’s sample, colorimetrically indicates whether the sample contains the species.
  • the device also includes a cap for sealing the container, where the cap is configured for receipt at the opening of the upper portion and which cannot be detached upon attachment thereto.
  • a cap for sealing the container, where the cap is configured for receipt at the opening of the upper portion and which cannot be detached upon attachment thereto.
  • bending the container at the weakened portion breaks open the ampoule, whereupon the liquid sample and the reagent can mix, with the colour of the resultant mixture being visible through one or more transparent portions (e.g. walls) of the container.
  • the diagnostic device of the present invention will be described below primarily in the context of the safe containment of liquid acidic reagents (pre- and post-use) and, in particular, mercury-containing liquid acidic reagents. It will be appreciated, however, that applications for the present invention are more extensive than this.
  • the diagnostic device may be used for the safe containment of any toxic or noxious reagent, biohazard, or system which generates a toxic or noxious by-product or a biohazardous waste. Liquid samples taken from patients are also potential biohazards, and safely containing them is therefore also advantageous.
  • Mercury-containing liquid acidic reagents such as Millon’s Reagent and the improved forms of Millon’s Reagent described in detail in the applicant’s earlier international patent application nos. PCT/AU2016/050067 and PCT/AU2022/051524, the contents of which are hereby incorporated by reference in their entirety, can be used to colorimetrically indicate the presence of certain species indicative of disease in a sample.
  • the presence of phenolic compounds such as tyrosine and its metabolites in a patient’s urine can be indicative of the patient having a cancer, for example, colorectal cancer.
  • Millon’s Reagent is exposed to a fluid sample containing phenolic compounds (e.g.
  • FIGs 1 to 3 depict a container (100) for a diagnostic device (102, see Figure 6) in accordance with an embodiment of the invention.
  • the container (100) is configured to receive a liquid sample from a patient (e.g. a urine, saliva or blood sample) and to house a glass ampoule (50, see Figure 7).
  • Container (100) has an upper portion (30), a lower portion (10) and a weakened portion (20) therebetween.
  • the weakened portion (20) may be sufficient to allow the container (100) to bend or flex in the region of the weakened portion and may, for example, be provided in the form of an area of reduced thickness.
  • the container (100) may be fabricated from any material that is stable when exposed to highly acidic or alkaline substances (although, as the material is only exposed to the reagent in a diluted form, a high stability may not necessarily be essential), and which is at least partially optically transparent.
  • the container may be fabricated from acrylic or polymethyl methacrylate (PMMA), polycarbonate (PC), polyethylene (PE), high density polyethylene, polymethyl pentene, polypropylene (PP), polyethylene terephthalate (PETE or PET), polyvinyl chloride (PVC), acrylonitrile-butadiene-styrene (ABS). bio thermoplastic polyurethane (Bio TPU) and polylactic acid (PLA), or the like.
  • the upper portion (30) has an opening (32) configured to receive the patient’s liquid sample.
  • the lower portion (10) is in fluid communication with the opening (32) and is also shaped to contain an ampoule (described below).
  • the diagnostic device (102) also includes a cap (described below, see Figures 4 to 8) that is configured for receipt at the opening (32) of the upper portion (30) in order to seal the container (100) such that no fluid can escape and which, upon attachment thereto, cannot be detached.
  • bending of the container (100) at the weakened portion (20) breaks open the ampoule (as described below), whereupon the sample and the reagent can mix, and a colour of the resultant mixture is visible through transparent walls (16) of the container (100).
  • the container (100) includes a chamber (18), which extends from the opening (32) of the upper portion (30) to the bottom of the lower portion (10).
  • the chamber (18) is configured to receive and retain an ampoule therein and provides a reaction chamber in which the reagent and the sample can mix and react in order to produce the colorimetric effect.
  • the chamber (18) is sized so as to receive a volume of the patient’s liquid sample sufficient to detect whether the sample contains the species, taking into consideration the volume of space occupied by the ampoule.
  • connecting the tabs (14) to the upper portion (30) in this manner may improve stability of the container about the weakened portion (20).
  • the container (100) and/or the cap (200) may also include printed information for a user, such as a warning or poisoning statement, expiry dates, instructions for use, branding, supplier information, or the like.
  • the lower portion (10) of the container (100) has transparent walls (16), through which the colour of the resultant mixture in chamber (18) is visible. The colour of this mixture may be compared to the colour chart described above, for example, to determine whether the patient’s sample contains the species indicative of disease.
  • the transparent walls (16) may be located on any suitable portion of the container (100).
  • the transparent walls (16) may be located on the lower end (34) of the upper portion (30) and/or on the at least one side wall (12) of the lower portion (10).
  • the transparent walls (16) may be located adjacent a tab (14) of the container (100).
  • the container (100) may be formed entirely from an opaque material, through which the colour of the liquid in chamber (18) can be discerned.
  • the upper portion (30) includes a circular dividing wall (38), with the inside of the dividing wall being in fluid communication with the lower portion (10) and the outside of the dividing wall (38) being in fluid communication with an overflow chamber (40), which is formed between the dividing wall and an outer wall (36) of the upper portion (30).
  • the height of the dividing wall (38) corresponds to a predefined volume of the liquid sample. In use, overflow will occur when the chamber (18) has been filled to the brim with the liquid sample, with the overflow being directed into the overflow chamber (40). When the container (100) is closed by the cap (200), as described below, any liquid overflow is retained within the overflow chamber (40) and cannot flow over the dividing wall (38), even when the container is shaken or inverted.
  • the upper portion (30) has a number of internal baffles (42).
  • the baffles (42) are located on an inner surface of the dividing wall (38) and act to channel the sample away from the opening (32) to the chamber (18). Baffles (42) may also assist with alignment of an ampoule (40) during its insertion into the container (100) so as to minimise the risk of the ampoule breaking during insertion. Finally, the baffles (42) also ensure that the top of the ampoule (40) is supported in a manner that quickly results in it breaking from the bottom upon binding of the device (102) about the weakened portion (20), as discussed in further detail below.
  • the upper portion (30) includes a screw-threaded portion (44). As will be described in further detail below, the screw-threaded portion enables cap (200) to be attached to the container (100).
  • the screw thread on the cap and/or upper portion of the container may be configured to operate in one way only, or include only a few threads which, once they have travelled over the corresponding threads of the other part, permanently disengage from that thread and effectively locking the cap to the container.
  • the cap and upper portion of the container may be configured with a snap lock-type fitting, where pressing the cap onto the opening causes the snap lock to engage and the cap thus irreversibly locked onto the container.
  • Cap (200) for use with the diagnostic device (102, see Figure 6).
  • Cap (200) is configured to be affixed to the opening (32), whereupon it seals the container (100) in a liquid-tight manner. Once screwed onto the container, the cap is prevented from moving in a direction that would unscrew the cap, thereby securely retaining the patient’s liquid sample and the reagent (i.e. once released from the ampoule, as described below) within the sealed device (102).
  • providing the diagnostic device with a cap configured to be irremovably placed on the container prevents access to or spillage of the liquid acidic reagents, fluid sample (e.g. a urine sample) and/or reaction by-products in the chamber (18).
  • the cap (200) includes a body (60) having an upper wall (62) and a tubular skirt (64), which extends downwardly from the upper wall (62).
  • a number of engagement elements shown in the form of ratchet engagement elements (66), are located on the lower edge of an inner wall of the skirt (64), above which is a screw-thread (68) that is complementary to screw thread (44) of container (100).
  • the pawl like projections (46) engage with the ratchet engagement elements (66), which prevents detachment of the cap (i.e. by unscrewing) after attachment to the container.
  • the cap (200) also has a transparent portion (70).
  • the transparent portion (70) is, in the depicted embodiment, located on the upper wall (62), but may be located on any suitable portion of the body (60), such as on the tubular skirt (64).
  • the colour of the liquid in the container may be viewed through the cap and compared with a colour chart to determine whether the patient’s liquid sample contains the species indicative of disease.
  • the colour of the liquid in the chamber may be compared to a colour chart printed on the skirt of the cap (200) to determine whether the liquid contains the species to be detected.
  • FIG. 6 a diagnostic device (102) in a closed configuration is illustrated.
  • the device includes a container (100) and a cap (200). As described above, cap (200) cannot be detached from container (100).
  • an ampoule (50) in an unopened condition is contained within the container (100) of the assembled device (102).
  • the ampoule (50) is received within the chamber (18) of the container (100), the chamber extending from the opening (32) of the container to the bottom of the lower portion (10).
  • the head (52) of the ampoule extends at least partially into the upper portion (30) of the container (100) where, as can be seen in Figure 7, it is located between opposing baffles (42).
  • the neck of the ampoule typically including a frangible portion in the form of a score line (54) is located at the weakened portion (20).
  • the weakened portion (20) of the container (100) thus causes the ampoule (50) to break at the score line (54).
  • the ampoule has been broken in this manner, its contents are released into the chamber (18), where they can mix with the patient’s liquid sample and react with any reactive species that may be present in the sample.
  • a resultant change in colour of the mixture can be comparted with a colour chart, for example, to indicate the presence of species in the sample that are indicative of abnormal cell behaviour.
  • FIG. 9 a flow diagram of a method (300) for detecting a species indicative of a disease in a patient is illustrated.
  • a diagnostic device such as that described above with reference to Figures 1 to 8, for example.
  • the device comprises an ampoule containing a reagent which, when contacted with the sample, colorimetrically indicates whether the sample contains the species; a container configured to receive the liquid sample, the container comprising an upper portion, a lower portion and a weakened portion therebetween; the upper portion comprising an opening configured to receive the sample, and the lower portion being in fluid communication with the upper portion and configured to receive therein the ampoule, and a cap configured for receipt at the opening of the upper portion and which, upon attachment thereto, cannot be detached.
  • Step C of the method a cap is secured to the upper portion. Once so attached (e.g. by screwing onto the container), the cap cannot be detached from the container.
  • one or more engagement elements engage with corresponding elements on the upper portion of the container located on an inner wall of the cap, whereby such engagement prevents detachment of the cap after attachment to the container.
  • the engagement elements may substantially prevent the cap from rotating in a direction which would enable the cap to be detached from the container.
  • Step D of the method the container is bent at its weakened portion to break open the ampoule so that the sample and the reagent can mix. Typically, bending the container at the weakened portion will break the ampoule at a micro-score in the ampoule, enabling the release of reagent held within the ampoule.
  • Step E of the method the sample and the reagent are caused to become mixed (e.g. by shaking, inverting or the like).
  • Step F of the method the colour of the resultant mixture is viewed through transparent walls of the container.
  • the colour of the resultant mixture may be compared with a colour chart to indicate the presence of the species in the sample.
  • the colour chart may be printed on the container, such as on a tab or tabs extending outwardly from the lower portion.
  • a positive result e.g. a matching colour
  • would prompt the patient to contact their medical service provider to arrange for further testing e.g. a colonoscopy, as described in PCT/AU2016/050067 and PCT/AU2022/051524.
  • the diagnostic device and method of the present invention enable users having no medical training to be able to test for markers that may indicate an underlying disease or condition. Any toxic reagents and biological species are safely and stably contained both pre- and post-use of the device.

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Abstract

Est divulgué dans la présente invention un dispositif de diagnostic pour indiquer de manière colorimétrique la présence d'une espèce indicative d'une maladie dans un échantillon liquide provenant d'un patient. Le dispositif comprend un récipient conçu pour recevoir l'échantillon liquide, le récipient comprenant une partie supérieure, une partie inférieure et une partie affaiblie entre celles-ci. La partie supérieure comprend une ouverture conçue pour recevoir l'échantillon liquide, et la partie inférieure est en communication fluidique avec la partie supérieure et conçue pour recevoir à l'intérieur de celle-ci une ampoule contenant un réactif qui, lorsqu'il est mis en contact avec l'échantillon liquide, indique de manière colorimétrique si l'échantillon liquide contient l'espèce. Le dispositif comprend également un capuchon pour sceller le récipient, le capuchon étant conçu pour être reçu au niveau de l'ouverture de la partie supérieure et qui, lors de la fixation à celle-ci, ne peut pas être détaché. Lors de l'utilisation, la courbure du récipient au niveau de la partie affaiblie rompt l'ouverture de l'ampoule, après quoi l'échantillon liquide et le réactif peuvent se mélanger et une couleur du mélange résultant est visible à travers une partie transparente (par exemple une paroi ou des parois transparentes) du récipient.
PCT/AU2024/050598 2023-06-08 2024-06-06 Dispositif de diagnostic et procédé d'utilisation Pending WO2024250069A1 (fr)

Priority Applications (1)

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AU2024284065A AU2024284065A1 (en) 2023-06-08 2024-06-06 A diagnostic device and a method of use

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AU2023901816A AU2023901816A0 (en) 2023-06-08 A diagnostic device and a method of use
AU2023901816 2023-06-08

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3741727A (en) * 1972-02-04 1973-06-26 Us Army Arsenic sampler
US5830344A (en) * 1995-02-22 1998-11-03 Environmental Technologies Group, Inc. Disposable sensor for metal analysis and method of using same
US20090068065A1 (en) * 2007-08-02 2009-03-12 Pagoria Philip F Simple, Field Portable Colorimetric Detection Device For Organic Peroxides and Hydrogen Peroxide
US20150037830A1 (en) * 2011-06-14 2015-02-05 Ax-Lab Innovation Aps Container assembly and associated method

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3741727A (en) * 1972-02-04 1973-06-26 Us Army Arsenic sampler
US5830344A (en) * 1995-02-22 1998-11-03 Environmental Technologies Group, Inc. Disposable sensor for metal analysis and method of using same
US20090068065A1 (en) * 2007-08-02 2009-03-12 Pagoria Philip F Simple, Field Portable Colorimetric Detection Device For Organic Peroxides and Hydrogen Peroxide
US20150037830A1 (en) * 2011-06-14 2015-02-05 Ax-Lab Innovation Aps Container assembly and associated method

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