Method and container for testing a sample

Abstract

The present disclosure provides a method, comprising: introducing a fluid sample into an inner container of a sample container, the inner container nestable and twistable relative to an outer container, the bottom wall of the inner container forming at least one aperture; and twisting the inner container relative to the outer container to establish fluid communication between the inner container and the outer container through the at least one aperture to allow at least a portion of the fluid sample to contact an indicator located between the inner and outer containers. The present disclosure also provides a sample container for performing said method.

Description

METHOD AND CONTAINER FOR TESTING A SAMPLEPRIORITY CLAIM

[0001] This application claims the benefit of and priority to U.S. Provisional Application No. 63 / 687,633 filed on August 27, 2024 and titled “METHOD AND CONTAINER FOR TESTING A SAMPLE,” the entire contents of which are herein incorporated by reference.FIELD

[0002] The present disclosure relates to a method and apparatus for testing a sample for one or more indications, for example, a fluid sample.BACKGROUND

[0003] The following paragraphs are not an admission that anything discussed in them is prior art or part of the knowledge of persons skilled in the art.

[0004] Fluid samples from a wide range of fields, including medical, environmental, industrial, and engineering applications, are tested for a variety of reasons, such as diagnosing and / or monitoring a health condition, ensuring environmental safety, monitoring industrial processes, and maintaining equipment.INTRODUCTION

[0005] The following introduction is intended to introduce the reader to this specification but not to define any invention. One or more inventions may reside in a combination or sub-combination of the apparatus elements or method steps described below or in other parts of this document. The inventors do not waive or disclaim their rights to any invention or inventions disclosed in this specification merely by not describing such other invention or inventions in the claims.

[0006] Collection of a fluid sample for testing routinely comprises an individual using a single, sterile container sealed with a lid. Generally, said container is opened at least once by the individual depositing the fluid sample, and again by trained personnel who test the fluid sample. One or more known apparatuses or methods for testing a fluid sample may: 1) increase the risk of contamination, for example, when the container is opened and exposed to ambient air between sample deposit and sample testing; 2) increase the risk of exposure to aharmful or hazardous toxin within the fluid sample, for example, when the container is opened and exposed to ambient air between sample deposit and sample testing; 3) decrease the efficiency of sample testing, for example, when using the entire fluid sample to run one or more tests; or 4) any combination thereof.

[0007] The present disclosure provides a method for selectively moving a desired portion of a fluid sample from a sample deposit section of a sample container to a testing section of the sample container under sealed conditions. The present disclosure also provides a sample container for performing the herein provided method.

[0008] Herein disclosed sample containers and methods may: 1) decrease the risk of contamination by, for example, maintaining the fluid sample under sealed conditions between sample deposit and sample testing; 2) decrease the risk of exposure of an individual to a harmful or hazardous toxin by, for example, maintaining the fluid sample under sealed conditions between sample deposit and sample testing; 3) increasing the efficiency of sample testing by, for example, selectively portioning the fluid sample for testing while maintaining the remaining fluid sample under sealed conditions; or 4) any combination thereof.

[0009] The present disclosure discusses a method comprising introducing a fluid sample into an inner container of a sample container. The inner container is nestable and twistable relative to an outer container. The bottom wall of the inner container forms at least one aperture. Twisting the inner container relative to the outer container establishes fluid communication between the inner container and the outer container through the at least one aperture to allow at least a portion of the fluid sample to contact an indicator located between the inner and outer containers.

[0010] The method may comprise twisting about the central axis of the inner container. The twisting may move the inner container towards or away from the outer container. The twisting may move the inner container towards or away from the outer container along the central axis. Moving the inner container away from the outer container may establish fluid communication between the inner and outer container. Moving the inner container towards the outer container may seal the at least one aperture.

[0011] The method may comprise the inner container being movable towards the outer container to physically engage the outer container at at least the portion forming the at least one aperture. The method may comprise the inner container being movable away from the outer container to create an annular gap between the inner and outer containers at at least theportion forming the at least one aperture. The method may comprise the inner container being nestable concentrically with the outer container.

[0012] The method may comprise twisting to secure the inner container in at least one position relative to the outer container. The one position may establish fluid communication between the inner container and the outer container. Another position may seal the at least one aperture. The method may comprise the totality of fluid communication between the inner container and the outer container being through the at least one aperture.

[0013] The method may comprise contacting the indicator with at least a portion of the fluid sample. The method may comprise the indicator being contacted by at least a portion of the fluid sample by pivoting the sample container around a point or along an edge thereof, wherein the point may be on the central axis.

[0014] The method may comprise, when nested, the sidewalls of the inner and outer containers meeting at at least one junction to produce a seal. The method may further comprise sealing the fluid sample within the inner container.

[0015] The method may comprise using the sample container disclosed herein.

[0016] The method may comprise the introduced fluid sample being a blood sample, a urine sample, a peritoneal fluid sample, a pericardial fluid sample, a pleural fluid sample, a synovial fluid sample, a cerebrospinal fluid sample, an amniotic fluid sample, a saliva sample, semen sample, and / or a cervical mucus sample. The introduced fluid sample may be a water sample, a wastewater sample, an air sample, a hydraulic fluid sample, an engine oil sample, a coolant sample, a chemical solvent sample, or a liquid fuel sample.

[0017] The present disclosure also discusses a sample container comprising an inner container with a body having at least one sidewall and a bottom wall defining an internal space to hold a fluid sample. The inner container is nestable and twistable relative to an outer container between an open position and a closed position. The bottom wall of the inner container forms at least one aperture. The sample container also comprises an indicator located between the inner and outer containers. When the sample container is in an open position, the inner and outer containers are in fluid communication through the at least one aperture. When the sample container is in a closed position, the at least one aperture is sealed.

[0018] The sample container may be twistable about its central axis and moveable along its central axis relative to the outer container. When nested, the inner container may be moveable away from the outer container when in an open position. The inner container maybe moveable towards the outer container when in a closed position. The sample container may be concentrically nestable with the outer container.

[0019] The sample container may comprise an outer container comprising at least one protrusion designed to engage with a corresponding track formed at the inner container. The track may have an inclined slope facilitating the relative motion between the inner and outer containers. The at least one protrusion may extend outwardly from the outer container. The at least one protrusion may be located near the opening of the outer container.

[0020] The sample container may comprise the corresponding track forming. The corresponding track may have a spiral path. The track may be located near the opening of the inner container. The corresponding track may form at least one notch designed to interact with the at least one protrusion securing the inner container in a specific position relative to the outer container. The corresponding track may form at least two notches spaced apart along the inclined slope, where the at least one protrusion interacts with the lower notch in an open position and the at least one protrusion interacts with the upper notch in a closed position. The lower notch may be closer to the bottom wall than the upper notch. The sample container may comprise an outer container comprising two protrusions and the inner container forming two corresponding tracks.

[0021] The sample container may comprise a sealer located between the inner and outer containers and aligned with the at least one aperture. The sealer may physically engage and seal the at least one aperture when in a closed position. The sealer may not be physically engaged with the at least one aperture when in an open position. The sealer may be a sealing ring, a gasket, a threaded connection, and / or an O-ring.

[0022] The sample container may comprise at least one sidewall forming at least one aperture. The inner and outer containers may be in fluid communication through the at least one aperture of the at least one sidewall when in an open position, and the at least one aperture of the at least one sidewall may be sealed in a closed position. Alternatively, the at least one aperture may be only formed by the bottom wall of the inner container.

[0023] When nested, the sample container may comprise an annular region bounded by at least a portion of the external surface of the inner container and at least a portion of the internal surface of the outer container forming an annular gap. The external surface of the inner container may be an external surface of the at least one sidewall.

[0024] The indicator may be located within the annular gap. The indicator may be couplable to the external surface of the inner container. The indicator may be configured to test the fluid sample for at least one indication. The indicator may be configured to activate upon contact with at least a portion of the fluid sample. The sample container may further comprise an indicator support. The indicator support may be shaped to correspond to the outer circumference of the inner container. The indicator may comprise a paper or plastic indicator strip, and / or the indicator may comprise paper, plastic, an indicator pad, a sponge, a dye, a powder, or a film.

[0025] The sample container, when nested, may comprise the sidewalls of the inner and outer containers meeting at at least one junction to produce a seal. The seal may be produced using a sealer, wherein the sealer may be a sealing ring, a gasket, a threaded connection, and / or an O-ring.

[0026] The sample container may comprise the inner container defining an opening opposite the bottom wall. The inner container may comprise a lid configured to cover the opening. The lid may comprise a sealing gasket to create a fluid-tight seal when the lid covers the opening.

[0027] The sample container may be used to hold a fluid sample such as a blood sample, a urine sample, a peritoneal fluid sample, a pericardial fluid sample, a pleural fluid sample, a synovial fluid sample, a cerebrospinal fluid sample, an amniotic fluid sample, a saliva sample, semen sample, and / or a cervical mucus sample. The fluid sample may be a water sample, a wastewater sample, an air sample, a hydraulic fluid sample, an engine oil sample, a coolant sample, a chemical solvent sample, or a liquid fuel sample.

[0028] Other aspects and features of the present disclosure will become apparent to those ordinarily skilled in the art upon review of the following description of specific embodiments in conjunction with the accompanying figures.BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Embodiments of the present disclosure will now be described, by way of example only, with reference to the attached Figures.

[0030] Fig. 1 is an exploded view of an example of a sample container according to the present disclosure.

[0031] Fig. 2 is a cross-sectional side view of the sample container illustrated in Fig. 1.

[0032] Figs. 3A-B are cut away illustrations of the sample container illustrated in Fig. 1 in an open position (Fig. 3A) and a closed position (Fig. 3B). Portions of the sidewalls of the inner and outer containers have been cut away as indicated by hatching.

[0033] Figs. 4A-B are cut away illustrations of another example of the sample container according to the present disclosure in an open position (Fig. 4A) and a closed position (Fig. 4B). Portions of the sidewalls of the inner and outer containers have been cut away as indicated by hatching.

[0034] Fig 5 is an exploded view of another example of a sample container according to the present disclosure.

[0035] Fig. 6 is an exploded view of the inner container and lid of the sample container illustrated in Fig. 5.

[0036] Fig. 7 is an exploded view of the outer container and the aperture blocker or sealer of the sample container illustrated in Fig. 5.

[0037] Fig. 8 is an exploded view of the indicator and indicator support of the sample container illustrated in Fig. 5.DETAILED DESCRIPTION

[0038] Generally, the present disclosure provides a method, comprising: introducing a fluid sample into an inner container of a sample container, the inner container nestable and twistable relative to an outer container, the bottom wall of the inner container forming at least one aperture; and twisting the inner container relative to the outer container to establish fluid communication between the inner container and the outer container through the at least one aperture to allow at least a portion of the fluid sample to contact an indicator located between the inner and outer containers.

[0039] The present disclosure also provides a sample container, comprising: an inner container comprising a body having at least one sidewall and a bottom wall defining an internal space to hold a fluid sample, the inner container nestable and twistable relative to an outer container between an open position and a closed position, wherein the bottom wall of the inner container forms at least one aperture; and an indicator between the inner and outer containers, wherein in an open position, the inner and outer containers are in fluid communication through the at least one aperture, and wherein in a closed position, the at least one aperture is sealed.

[0040] In the context of the present disclosure, a sample is any fluid that is desired to be tested to gather information about the composition, quality, function, and / or potential hazards of the fluid. The type and number of tests will vary depending on the desired information and field of testing. For example, in medical diagnosis and monitoring, a fluid sample may be tested to detect a disease or disorder, such as an infection, diabetes, and liver disease; monitor health, such as monitoring glucose levels, pH levels, and cholesterol; and / or screening for conditions, disorders, or complications, such as genetic conditions, neurological disorders, and pregnancy complications. Examples of fluid samples used in medical diagnosis and monitoring include blood, urine, peritoneal fluid, pericardial fluid, pleural fluid, synovial fluid, cerebrospinal fluid, amniotic fluid, saliva, semen, and cervical mucus. In the field of environmental safety, water, wastewater, and air samples may be tested to identify pollutants, contaminants, and toxins. In the field of industry and engineering, chemicals, liquid fuel, hydraulic fluid, coolant, and engine oil may be tested to identify contamination, viscosity, and quality. In the field of research and development, chemical solvents and fuel compositions may be tested to identify toxins or to determine the properties and compositions of the fluids for developing testing products or new products. In the public health and safety field, fluid samples may be tested to identify biological, chemical, or radioactive substances in the fluids that may pose a risk to public health or to ensure that the fluids meet legal and safety standards.

[0041] Introducing a fluid sample into an inner container of a sample container refers to placing the fluid sample into one container of at least a two-container system. The one container being the inner container having at least a sidewall and bottom wall defining a space therebetween sufficiently large to hold the fluid sample. The inner container also comprises an open end opposite the bottom wall through which the fluid sample can be introduced. The volume or size of the inner container may vary depending on the type of fluid sample for testing and / or type of testing. For example, a routine urinalysis typically requires about 30 mL to about 50 mL of urine, however, a typical semen sample for testing is from about 1 .5 mL to about 5.0 mL. Moreover, a typical drug test may require more urine than a routine urinalysis, for example, from about 45 mL to about 60 mL. In some examples, the inner container has a volume of from about 1 mL to about 100 mL; about 1 mL; about 2 mL; about 3 mL; about 4 mL; about 5 mL; about 6 mL; about 7 mL; about 8 mL; about 9 mL; about 10 mL; about 11 mL; about 12 mL; about 13 mL; about 14 mL; about 15 mL; about 16 mL; about 17 mL; about 18 mL; about 19 mL; about 20 mL; about 25 mL; about 30 mL; about 35 mL; about 40 mL; about 45 mL; about50 mL; about 55 mL; about 60 mL; about 65 mL; about 70 mL; about 75 mL; about 80 mL; about 85 mL; about 90 mL; about 95 mL; about 100 mL; or from any one of the previously received volumes to any other previously recited volumes. The shape of the inner container may vary provided that the inner container is able to hold the fluid sample. In some examples, the inner container is cylindrical, rectangular or cuboidal, spherical, conical, pyramidical, oval or elliptical, hexagonal, triangular, capsule, or an irregular or custom shape.

[0042] Optionally, the inner container is made of a material sufficient to hold the fluid sample without leakage and be sterilizable. The material may also be clear or translucent to allow for visual inspection of the fluid sample within the container. Optionally, the material is disposable for hygiene and convenience after a single use. Examples of the material include polypropylene or polyethylene plastic, and glass.

[0043] The bottom wall of the inner container forms at least one aperture. The at least one aperture is of sufficient size to allow at least a portion of the fluid sample within the inner container to flow therethrough by gravitational force and exit the inner container when the aperture is open or free from obstruction. The size and number of apertures formed by the bottom wall may vary provided that at least one aperture is of sufficient size to allow at least a portion of the fluid sample to flow therethrough. Optionally, the size of the at least one aperture is from about 0.1 mm to about 10 mm in diameter, for example, about 0.1 mm; about 0.2 mm; about 0.3 mm; about 0.4 mm; about 0.5 mm; about 0.6 mm; about 0.7 mm; about 0.8 mm; about 0.9 mm; about 1.0 mm; about 2.0 mm; about 3.0 mm; about 4.0 mm; about 5.0 mm; about 6.0 mm; about 7.0 mm; about 8.0 mm; about 9.0 mm; about 10.0 mm in diameter; or the size of the at least one aperture is from any one of the previously recited sizes to any other of the previous recited sizes. Optionally, the inner container may form one or more apertures in the sidewall. In some examples, the only aperture or apertures formed by the inner container are located at the bottom wall of the inner container. In some examples, the bottom wall of the inner container forms from 1 aperture to 20 apertures; 1 aperture; 2 apertures; 3 apertures; 4 apertures; 5 apertures; 6 apertures; 7 apertures; 8 apertures; 9 apertures; 10 apertures; 11 apertures; 12 apertures; 13 apertures; 14 apertures; 15 apertures; 16 apertures; 17 apertures; 18 apertures; 19 apertures; 20 apertures; or the number of apertures is from any one of the previously recited number of apertures to any other of the previous recited apertures. In examples of inner containers forming multiple apertures, the size of each of the multiple apertures may be uniform or may vary from another of the multiple apertures. The aperturesmay be arranged in a defined pattern or organization such as a linear array, radial arrangement, grid pattern, or irregular distribution depending on the functional requirements of fluid flow, pressure distribution, or other design criteria.

[0044] The fluid sample may be placed into the inner container by any known method. In some examples, the fluid sample is transferred directly from an individual’s body to the sample container, for example, urinating directly into the inner container. In other examples, equipment such as a needle, syringe, pipette, or funnel is used to transfer the fluid sample from the source of the sample into the inner container. To avoid contamination, the equipment may be clean and sterilized.

[0045] The outer container has at least a sidewall and bottom wall defining a space therebetween sufficiently large to accommodate at least a portion of the inner container. The outer container also comprises an open end opposite the bottom wall through which the inner container is inserted into the outer container. Being nestable and twistable relative to the outer container refers to the inner container and the outer container being designed such that at least a portion of the inner container fits inside the outer container, and while inside, the inner container has the ability to be twisted or rotated in relation to the outer container. The twisting or rotating may be caused by manual action using normal turning force easily applied by hand or the action may be automated. The volume or size and shape of the outer container may vary provided that the inner container is nestable therein and is able to be twisted or rotated within the outer container. The degree of nesting, which includes the depth of insertion and fit and tolerance, may vary provided that the inner container is accessible to accept a fluid sample while nested and the inner container is twistable or rotatable while nested. The inner container may comprise a ridge positioned circumferentially or partially around the external surface of the sidewall of the inner container and configured to abut the top edge or end of the sidewall of the outer container, or abut a ridge positioned circumferentially or partially around the internal surface of the sidewall of the outer container, when the inner and outer containers are nested thereby preventing the inner container from nesting further into the outer container beyond a predetermined depth. The ridge acts as a physical stop ensuring the inner container remains at a fixed depth within the outer container providing consistent alignment and spacing between the two containers. The space between the inner and outer containers, when nested, is defined as the annular region bounded by the external surface of the inner container and the internal surface of the outer container. This space, referred to as the annular gap, forms a shellaround at least a portion of the inner container. The volume of the annular gap may vary provided that the inner container is twistable or rotatable relative to the outer container when nested. In some examples, the annular gap is sufficiently small such that when nested: 1) portions of the external surface of the sidewall of the inner container physically contact corresponding portions of the internal surface of the sidewall of the outer container; and 2) the inner container is twistable or rotatable relative to and within the outer container. These examples may be desirable for facilitating frictional twistable or rotational retention and / or by forming a seal between the inner and outer containers at the portions of physical contact. Optionally, the inner container is concentrically nestable with the outer container such that the central axis of the inner container aligns with the central axis of the outer container.

[0046] Optionally, the outer container is made of a material sufficient to hold the fluid sample without leakage and be sterilizable. The material may also be clear or translucent to allow for visual inspection of the contents of the outer container, including the fluid sample and / or the indicator. Optionally, the material is disposable for hygiene and convenience after a single use. Examples of material include polypropylene or polyethylene plastic, and glass.

[0047] Twisting or rotating refers to moving the inner container about its central axis relative to the outer container. The degree of twisting or rotating may vary, for example, the inner container may be twisted or rotated about 1 degree to about 360 degrees in either direction relative to the outer container. In some examples, the degree of rotation is from about 1 degree to about 180 degrees, for example, about 1 degree; about 2 degrees; about 3 degrees; about 4 degrees; about 5 degrees; about 10 degrees; about 15 degrees; about 20 degrees; about 25 degrees; about 30 degrees; about 35 degrees; about 40 degrees; about 45 degrees; about 50 degrees; about 60 degrees; about 70 degrees; about 80 degrees; about 100 degrees; about 120 degrees; about 140 degrees; about 160 degrees; about 180 degrees; or from any one of the previously recited degrees to any other of the previously recited degrees.

[0048] Optionally, while nested, the sidewalls of the inner and outer containers meet at at least one junction, which forms a seal therebetween. Alternatively, while nested, the sidewalls of the inner and outer containers meet at at least one junction through an intermediary sealer, such as a sealing ring, a gasket, a threaded connection, and / or an O-ring. The at least one junction is a certain point at which: 1) the sidewalls of the inner and outer containers touch or meet directly or through a sealer, to form a seal which prevents fluid leakage, contamination, and / or air entering or exiting between the inner and outer containers;and / or 2) the top edge or end of the sidewall of the outer container and the sidewall of the inner container, or the top edge or ends of the sidewalls of the inner and outer containers, touch or meet directly or through a sealer, to form a seal which prevents fluid leakage, contamination, and / or air entering or exiting between the inner and outer containers. The junction may span the circumference of the inner container and create a continuous seal that covers the entire junction where the inner and outer containers touch or meet directly or though a sealer. The size or area of the junction and / or the type or size of the sealer may vary provided that when nested, the inner container is twistable or rotatable relative to the outer container. In examples where the top edges or ends of the sidewalls of the inner and outer containers touch or meet, the inner container may comprise a ridge or rim formed at the top edge or end of its sidewall that spans the perimeter of the open end and touches or meets the top edge or end of the sidewall of the outer container.

[0049] The herein disclosed container comprises at least one indicator located between the inner and outer containers. The indicator may be located in the herein disclosed annular gap or between the bottom wall of the inner container and the bottom wall of the outer container. Optionally, the herein disclosed container comprises more than one indicator located between the inner and outer containers. The indicator may be any substrate that is able to detect the presence or a characteristic of the fluid sample when it comes into contact with the fluid sample. The indicator may be chemically and / or physically responsive to one or more properties of the fluid sample, for example, the indicator may undergo a change in color, fluorescence, or electrical conductivity, or any other measurable change. The indicator may provide an indication of the presence, concentration, or specific property of the fluid sample, for example, pH level, biological or chemical composition, or the presence of a specific analyte, for example, a hormone, antibody, inorganic acid, organic acid, amino acid, protein, enzyme, fat, sugar, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), purine and / or pyrimidine, red and / or white blood cells, a virus, a bacteria, or any combination thereof. In some examples, the indicator is a paper, a plastic, an indicator pad, a sponge, a dye, a powder, or a film. As disclosed herein, the outer container may be clear or translucent to allow for visual inspection of the contents within the outer container, including the indicator.

[0050] Optionally, the indicator is couplable to the external surface of the inner container or the internal surface of the outer container. Optionally, the indicator is couplable to the inner or outer container via an indicator support. The indicator support may be shaped tocorrespond to the external circumference of the sidewall of the inner container or to the internal circumference of the sidewall of the outer container to form a band encircling the external surface of the inner container. The indicator support may be used to secure one or more indicators between the inner and outer containers. The indicator support may have an elastic or rigid material composition. The material may be sterilizable and / or disposable for hygiene and convenience after a single use. Examples of the material include polypropylene or polyethylene plastic, and glass.

[0051] Twisting the inner container relative to the outer container to establish fluid communication between the inner and outer container refers to selectively unblocking or unsealing the herein disclosed at least one aperture by twisting or rotating the inner container relative to the outer container to allow a desired portion of sample fluid located within the inner container to flow through the at least one aperture and exit the inner container and enter the outer container. The desired portion of sample fluid within the outer container is able to contact the herein disclosed indicator for testing the sample fluid.

[0052] The herein disclosed twisting or rotating moves the inner container between a closed position, which blocks or seals the herein disclosed at least one aperture and disallows fluid communication through the at least one aperture thereby maintaining fluid sample within the inner container, and an open position, which unblocks or unseals the herein disclosed at least one aperture allowing fluid communication through the herein disclosed at least one aperture. Allowing fluid communication and disallowing fluid communication through the at least one aperture may be performed by moving the at least one aperture towards or away from an aperture blocker or sealer, for example, by: 1) moving the at least one aperture upwards or downwards relative to an aperture blocker or sealer; and / or 2) moving the at least one aperture laterally towards or away from an aperture blocker or sealer.

[0053] In some examples of moving the at least one aperture towards or away from an aperture blocker or sealer, while nested, twisting or rotating the inner container relative to the outer container moves or slides the inner container along its central axis relative to the outer container causing the inner container to move towards or away from the outer container. When the inner container is moved towards the outer container, an aperture blocker or sealer couplable to the outer container, or formed from a portion of the internal surface of the bottom wall of the outer container, and in an alignment with the at least one aperture, physically engages and seals or blocks the at least one aperture thereby disallowing the sample fluid toflow through the at least one aperture. In this sealed or blocked position, the sample container may be referred to being in a closed position. When the inner container is moved away from the outer container, the aperture blocker or sealer physically disengages and unseals or unblocks the at least one aperture thereby allowing the sample fluid to flow through the at least one aperture. In this unsealed or unblocked position, the sample container may be referred to being in an open position. Optionally, the herein disclosed aperture blocker or sealer is any barrier that is in alignment with the at least one aperture and is configured to seal or block the aperture when physically engaged with the aperture. Examples of blockers and sealers include a sealing ring, a gasket, a threaded connection, an O-ring, and / or a portion of the bottom wall of the outer container.

[0054] Optionally, moving the inner container towards or away from the outer container along the axis of the inner container is performed using a track mechanism. The outer container comprises at least one protrusion or peg that extends outwardly from the outer container and is designed to engage with at least one corresponding track formed at the inner container that is designed to receive the at least one protrusion or peg. Each track is inclined forming a helical or spiral path that slopes upwards away from the bottom wall of the inner container. As the inner container is twisted or rotated relative to the outer container, the at least one protrusion or peg moves along the inclined track, which guides the inner container towards or away from the outer container along the central axis of the inner container. Each herein disclosed inclined track may comprise end or stop points that prevent further movement of that at least one protrusion or peg along the track. When the inner container is twisted or rotated in a direction that moves the at least one protrusion along the inclined track in a direction towards the bottom wall of the inner container, the inner container moves away from the outer container into an open position. When the inner container is twisted or rotated in a direction that moves the at least one protrusion along the inclined track in a direction away from the bottom wall of the inner container, the inner container moves towards the outer container into a closed position. The location and number of protrusions or pegs and corresponding tracks may vary depending on the sample container size and use. For example, relatively large containers may comprise more protrusions or pegs and tracks, while relatively small containers may comprise fewer protrusions or pegs and tracks. In some examples, the outer container comprises two protrusions or pegs located near or at the opening of the outer container on about opposite regions of the sidewall such that each region is about 180 degrees from the other region whenmeasured around the circumference of the sidewall of the outer container. In such examples, the inner container comprises two inclined tracks corresponding and engageable with the two protrusions or pegs, located near or at the opening of the inner container on about opposite regions of the sidewall of the inner container.

[0055] Optionally, the herein disclosed inclined track forms at least one notch designed to interact with the at least one protrusion or peg and secure the inner container in a specific position relative to the outer container. The at least one notch is a recessed area within the inclined track that creates a detent mechanism allowing the at least one protrusion or peg to snap into place and resist further movement along the inclined track unless additional force is applied. The at least one notch provides a discrete locking point, ensuring that the inner container remains securely in place until the inner container is twisted or rotated again to release the at least one protrusion or peg from the notch. In some examples, each herein disclosed inclined track comprises two notches spaced apart along the inclined slope resulting in a lower notch closer to the bottom wall of the inner container and an upper notch. In some examples, the at least one protrusion or peg snaps into the lower notch securing the inner and outer container in an open position, and the at least one protrusion or peg snaps into the upper notch securing the inner and outer container in a closed position.

[0056] In other examples of moving the at least one aperture towards or away from an aperture blocker or sealer, the at least one aperture is located off-center such that the at least one aperture is displaced from the central axis of the bottom wall of the inner container. Similarly, an aperture blocker or sealer couplable to the internal surface of the bottom wall of the outer container, or formed from a portion of the internal surface of the bottom wall of the outer container, is located off-center such that the aperture blocker or sealer is displaced from the central axis from the bottom wall of the outer container. While nested, twisting or rotating the inner container relative to the outer container aligns or disaligns the at least one aperture with the aperture blocker or sealer. The twisting or rotating may also cause the inner container to move towards or away from the outer container along the central axis of the inner container as disclosed herein. Alternatively, the twisting or rotating does not cause the inner container to move towards or away from the outer container along the central axis of the inner container.

[0057] When the inner container is twisted or rotated to align the at least one aperture with the aperture blocker or sealer, the at least one aperture physically engages and seals or blocks the at least one aperture thereby disallowing the sample fluid to flow through the at leastone aperture. In this sealed or blocked position, the sample container may be referred to being in a closed position. When the inner container is twisted or rotated to disalign the at least one aperture from the aperture blocker or sealer, the at least one aperture physically disengages and unseals or unblocks the at least one aperture thereby allowing the sample fluid to flow through the at least one aperture. In this unsealed or unblocked position, the sample container may be referred to being in an open position. Optionally, the herein disclosed aperture blocker or sealer is any barrier that can be aligned with the at least one aperture and is configured to seal or block the aperture when physically engaged with the aperture. Examples of blockers and sealers include a sealing ring, a gasket, a threaded connection, an O-ring, and / or a portion of the bottom wall of the outer container.

[0058] Optionally, twisting or rotating the inner container relative to the outer container to align or disalign the at least one aperture with the aperture blocker or sealer without causing the inner container to move towards or away from the outer container along the central axis of the inner container is performed using a track mechanism. The outer container comprises at least one protrusion or peg that extends outwardly from the outer container and is designed to engage with at least one corresponding track formed at the inner container that is designed to receive the at least one protrusion or peg. Each track is substantially planar such that it is neither inclined nor declined maintaining an about uniform height relative to a reference plane parallel to the top surface of the inner container. As the inner container is twisted or rotated relative to the outer container, the at least one protrusion or peg moves along the substantially planar track maintaining the distance between the inner and outer containers along the central axis of the inner container. Each herein disclosed substantially planar track may comprise end or stop points that prevent further movement of that at least one protrusion or peg along the track. In some examples, the outer container comprises two protrusions or pegs located near or at the opening of the outer container on about opposite regions of the sidewall such that each region is about 180 degrees from the other region when measured around the circumference of the sidewall of the outer container. In such examples, the inner container comprises two substantially planar tracks corresponding and engageable with the two protrusions or pegs, located near or at the opening of the inner container on about opposite regions of the sidewall of the inner container.

[0059] Optionally, the herein disclosed substantially planar track forms at least one notch designed to interact with the at least one protrusion or peg and secure the inner containerin a specific position relative to the outer container. The at least one notch is a recessed area within the substantially planar track that creates a detent mechanism allowing the at least one protrusion or peg to snap into place and resist further movement along the substantially planar track unless additional force is applied. The at least one notch provides a discrete locking point, ensuring that the inner container remains securely in place until the inner container is twisted or rotated again to release the at least one protrusion or peg from the notch. In some examples, each herein disclosed substantially planar track comprises two notches spaced apart. In some examples, the at least one protrusion or peg snaps into one of the two notches when the at least one aperture is disaligned with the aperture blocker or sealer thereby securing the inner and outer container in an open position, and the at least one protrusion or peg snaps into the other notch when the at least one aperture is aligned with the aperture blocker or sealer thereby securing the inner and outer container in a closed position.

[0060] Optionally, the aperture blocker or sealer is couplable to the internal surface of the bottom wall of the outer container through a support structure or raised platform that positions the aperture blocker or sealer in a raised position or a position closer to the bottom wall of the inner container relative to the bottom wall of the outer container when nested. The support structure or raised platform allows the blocker or sealer to physically engage the area of the bottom wall of the inner container forming the at least one aperture while providing clearance between other areas of the bottom wall of the inner container and the bottom wall of the outer container. In some examples, the aperture blocker or sealer is the support structure or raised platform. In some examples, the herein disclosed indicator is located within said other areas of clearance.

[0061] Optionally, the inner container has a lid configured to selectively cover the opening of the inner container. The lid may comprise one or more sealers to create a fluid-tight seal when the lid covers the opening, and / or a joint or hinge mechanism through which it is couplable to the sidewall of the inner container.

[0062] In use, a desired indicator is inserted between nested inner and outer containers. During nesting, the protrusion(s) or peg(s) of the outer container are aligned and engage with the corresponding track(s) on the inner container. Once nested, a user causes the inner container to twist or rotate into a closed position such that the at least one aperture is blocked or sealed. When in the closed position, the sample fluid is introduced into the inner container through the inner container opening. Optionally, to decrease contamination and / orthe risk of toxins being released from the fluid sample, the lid covering the opening of the inner container is closed and is maintained in a closed position until the testing is complete. While in a closed position, the sample fluid remains contained in the inner container and does not flow out of the inner container or into the outer container. A user causes the inner container to twist or rotate relative to the outer container from a closed position into an open position thereby unblocking or unsealing the at least one aperture allowing at least a portion of the sample fluid to flow through the at least one aperture from the inner container into the outer container. The user can select a desired portion of the fluid sample to flow through the at least one aperture by adjusting the degree of twisting or rotating and / or the length of time the inner container and outer container are in an open position. When the desired amount of sample fluid has flowed through the at least one aperture, the user causes the inner container to twist or rotate relative to the outer container from an open position into a closed position thereby blocking or sealing the at least one aperture preventing sample fluid from flowing therethrough. In examples where the indicator is located between the bottom walls of the inner and outer container, the sample fluid in the outer container may contact the indicator as soon as it flows through the at least one aperture. Alternatively, if the indicator is located between the bottom walls of the inner and outer containers but not in alignment with the at least one aperture, or if the indicator is located between the sidewalls of the inner and outer containers, the user may cause the sample container to tilt or pivot to cause the fluid sample within the outer container to contact the indicator. Following a sufficient time for the indicator to activate, the indicator may be viewed through the clear or translucent outer container without unnesting the inner and outer containers. Once the test is over, the user may cause the inner container to twist or rotate relative to the outer container from a closed position into an open position thereby unblocking or unsealing the at least one aperture allowing another portion of the sample fluid to flow through the at least one aperture from the inner container into the outer container for further testing. Alternatively, the user may open the lid and transfer the remaining fluid sample for further testing or disposal.

[0063] Optionally, the sample container has a cover configured to selectively cover the track mechanism disclosed herein. The cover may also be configured to cover the at least one junction at the meeting of the inner and outer containers. The cover may be shaped to correspond to the external circumference of the sidewall of the outer container to form a band encircling the external surface of the sidewall of the outer container. The cover may beadjustable between a covered position, which covers the track mechanism and / or the at least one junction at the meeting of the inner and outer containers, and an uncovered position, which does not cover the track mechanism and / or the at least one junction at the meeting of the inner and outer containers. The cover may be used, when in the covered position, to prevent the inner container from being twisted or rotated relative to the outer container when nested in an open or closed position, and / or to prevent or decrease leakage of fluid sample that has been deposited into the inner container and / or has entered the outer container. The cover may have an elastic or rigid material composition. The material may be sterilizable and / or disposable for hygiene and convenience after a single use. Examples of the material include polypropylene or polyethylene plastic, and glass.

[0064] Figs. 1 and 2 illustrate one example of a sample container according to the present disclosure in an exploded view (see Fig. 1) and a cross-sectional collapsed view (see Fig. 2). The sample container (100) comprises an inner container (102) with a body having at least one sidewall (104) and a bottom wall (106) defining an internal space (108) to hold a fluid sample (not shown). The inner container (102) is nestable and twistable relative to an outer container (110) between an open position (see Fig. 3A) and a closed position (see Fig. 3B). The bottom wall of the inner container (106) forms at least one aperture (112). In Fig. 2, the at least one aperture (112) is shown to be blocked or sealed. The sample container (100) also comprises an indicator (114) located between the inner and outer containers (102, 110). When the sample container (100) is in an open position, the inner and outer containers (102, 110) are in fluid communication through the at least one aperture (112). When the sample container (100) is in a closed position, the at least one aperture (112) is blocked or sealed. When the inner and outer containers (102, 110) are nested, the sidewall of the inner container (104) touches or meets the sidewall of the outer container (116) through a sealer (118) to form a seal which prevents fluid leakage, contamination, and / or air entering or exiting between the inner and outer containers (102, 110). The sample container (100) also comprises a support structure or raised platform (120) to physically engage and seal or block the at least one aperture (112) in a closed position, and to physically disengage and unseal or unlock the at least one aperture (112) in an open position.

[0065] Figs. 3A-B are cut-away illustrations of the example sample container illustrated in Figs. 1 and 2 shown in an open position (see Fig. 3A) and a closed position (see Fig. 3B). Portions of the sidewalls of the inner and outer containers (104, 116) are cut away as indicatedby hatching. In an open position, the inner container (102) is moved away from the outer container (110) along its central axis (shown as dotted line) causing the at least one aperture (112) to be physically disengaged from the support structure or raised platform (120) thereby unsealing or unblocking the at least one aperture (112) to allow at least a portion of the sample fluid to flow through the at least one aperture (112) from the inner container (102) into the outer container (110). To move from an open position to a closed position, twisting or rotating the inner container (102) relative to the outer container (110) causes the inner container to move towards the outer container (110) along its central axis causing the at least one aperture (112) to physically engage the support structure or raised platform (120) thereby sealing or blocking the at least one aperture (112) disallowing the sample fluid to flow through the at least one aperture (112). The movement is performed using a track mechanism (not shown; see Figs. 5-6). To move from a closed position to an open position, twisting or rotating the inner container (102) relative to the outer container (110) in the opposite direction as moving from an open position to a closed position causes the inner container to move away the outer container (110) along its central axis causing the at least one aperture (112) to physically disengage the support structure or raised platform (120) thereby unsealing or unblocking the at least one aperture (112) to allow at least a portion of the sample fluid to flow through the at least one aperture from the inner container (102) into the outer container (110).

[0066] Figs. 4A-B are cut-away illustrations of another example of the sample container according to the present disclosure, shown in an open position (see Fig. 4A) and a closed position (see Fig. 4B). Portions of the sidewalls of the inner and outer containers (404, 416) are cut away as indicated by hatching. In this sample container (400), both the at least one aperture in the bottom wall of the inner container (412) and the support structure or raised platform (420) are displaced from the central axis of the bottom wall of the inner container (406). Further, the inner container (402) is twistable or rotatable relative to the outer container (410) without causing the inner container (402) to move towards or away from the outer container (410) along its central axis (shown as dotted line). When nested, the sidewalls of the inner and outer containers touch or meet directly to form a seal which prevents fluid leakage, contamination, and / or air entering or exiting between the inner and outer containers. In an open position, the at least one aperture (412) is physically disengaged and disaligned from the support structure or raised platform (420) thereby unsealing or unblocking the at least one aperture (412) to allow at least a portion of the sample fluid to flow through the at least oneaperture (412) from the inner container (402) into the outer container (410). To move from an open position to a closed position, twisting or rotating the inner container (402) relative to the outer container (410) causes the at least one aperture (412) to be aligned and physically engaged with the support structure or raised platform (420) thereby sealing or blocking the at least one aperture (412) disallowing the sample fluid to flow through the at least one aperture (412). The movement is performed using a track mechanism (now shown; see Figs. 5-6). To move from a closed position to an open position, twisting or rotating the inner container (402) relative to the outer container (410) in the opposite direction as moving from an open position to a closed position causes the at least one aperture (412) to disalign and physically disengage the support structure or raised platform (420) thereby unsealing or unblocking the at least one aperture (412) to allow at least a portion of the sample fluid to flow through the at least one aperture from the internal space of the inner container (408) into the outer container (410), and allow at least a portion of the fluid sample to contact an indicator (414) located between the inner and outer containers (402, 410).

[0067] Figs. 5-8 illustrate another example of a sample container according to the present disclosure in an exploded view (see Fig. 5), and in illustrations of the inner container and lid (see Fig. 6), the outer container and aperture blocker or sealer (see Fig. 7), and the indicator and indicator support (see Fig. 8) in isolation. The sample container (500) comprises an inner container (502) with a body having at least one sidewall (504) and a bottom wall (506) defining an internal space (508) to hold a fluid sample (not shown). The inner container (502) is nestable and twistable relative to an outer container (510) between an open position (see Fig. 3A) and a closed position (see Fig. 3B). The bottom wall of the inner container (506) forms at least one aperture (not shown). The sidewall of the inner container (504) forms a track mechanism (522, 528) with an inclined track (522) designed to engage with at least one corresponding protrusion or peg (528) extending outwardly from the outer container (510). The track mechanism (522) comprises an upper notch (524) and a lower notch (526) within the inclined track, which provide discrete locking points for the inner container (502) while nested in the outer container (510). The inner container (502) further comprises a lid (530) to selectively cover the opening of the inner container (502). The lid (530) is attached to the sidewall of the inner container (504) via a joint or hinge mechanism (532), and further comprises one or more sealers (518) to create a fluid-tight seal when the lid (530) covers the opening. The sample container (500) also comprises an aperture blocker or sealer (534) thatis couplable to the bottom wall of the inner container of the outer container (510) in an alignment with and physically engageable with the at least one aperture (not shown) when in a closed position. The sample container (500) further comprises a cover (536) as herein disclosed. The sample container (500) also further comprises an indicator (514) and an indicator support (538). The indicator (514) is a paper or plastic strip couplable to and secured in place by the indicator support (538). The indicator support (538) is shaped to correspond to the internal circumference of the sidewall of the outer container (516) and to form a band encircling the external surface of the sidewall of the inner container (504). The indicator and indicator support (514, 538) are located in the herein disclosed annular gap when the inner container (502) is nested in the outer container (510). In the preceding description, for purposes of explanation, numerous details are set forth in order to provide a thorough understanding of the embodiments. However, it will be apparent to one skilled in the art that these specific details are not required.

[0068] The above-described embodiments are intended to be examples only. Alterations, modifications and variations can be effected to the particular embodiments by those of skill in the art. The scope of the claims should not be limited by the particular embodiments set forth herein, but should be construed in a manner consistent with the specification as a whole.

Claims

WHAT IS CLAIMED IS:1 . A sample container, comprising: an inner container comprising a body having at least one sidewall and a bottom wall defining an internal space to hold a fluid sample, the inner container nestable and twistable relative to an outer container between an open position and a closed position, wherein the bottom wall of the inner container forms at least one aperture; and an indicator between the inner and outer containers, wherein in an open position, the inner and outer containers are in fluid communication through the at least one aperture, and wherein in a closed position, the at least one aperture is sealed.

2. The sample container of claim 1 , wherein the inner container is twistable about its central axis and moveable along its central axis relative to the outer container.

3. The sample container of claim 2, wherein when nested, the inner container is moveable away from the outer container when in an open position.

4. The sample container of claim 2 or 3, wherein when nested, the inner container is moveable towards the outer container when in a closed position.

5. The sample container of any one of claims 1-4, wherein the inner container is concentrically nestable with the outer container.

6. The sample container according to any one of claims 1-5, wherein the outer container comprises at least one protrusion designed to engage with a corresponding track formed at the inner container, wherein the track has an inclined slope facilitating the relative motion between the inner and outer containers.

7. The sample container according to claim 6, wherein the at least one protrusion extends outwardly from the outer container.

8. The sample container of claim 6 or 7, wherein the track forms a spiral path.

9. The sample container according to any one of claims 6-8, wherein the at least one protrusion is located near the opening of the outer container.

10. The sample container according to any one of claims 6-9, wherein the corresponding track is located near the opening of the inner container.

11. The sample container according to any one of claims 6-10, wherein the track forms at least one notch designed to interact with the at least one protrusion securing the inner container in a specific position relative to the outer container.

12. The sample container of claim 11 , wherein the track forms two notches spaced apart along the inclined slope, wherein the at least one protrusion interacts with the lower notch in an open position and the at least one protrusion interacts with the upper notch in a closed position.

13. The sample container of claim 12, wherein the lower notch is closer to the bottom wall than the upper notch.

14. The sample container according to any one of claims 6-13, wherein the outer container comprises two protrusions and the inner container forms two corresponding tracks.

15. The sample container according to any one of claims 1-14, further comprising a sealer located between the inner and outer containers and aligned with the at least one aperture.

16. The sample container of claim 15, wherein the sealer physically engages and seals the at least one aperture when in a closed position.

17. The sample container of claim 15 or 16, wherein the sealer is not physically engaged with the at least one aperture when in an open position.

18. The sample container according to any one of claims 15-17, wherein the sealer is a sealing ring, a gasket, a threaded connection, and / or an O-ring.

19. The sample container according to any one of claims 1-18, wherein the at least one sidewall forms at least one aperture, wherein the inner and outer containers are in fluid communication through the at least one aperture of the at least one sidewall when in an open position, and the at least one aperture of the at least one sidewall is sealed in a closed position.

20. The sample container according to any one of claims 1-18, wherein the at least one aperture is only formed by the bottom wall of the inner container.

21. The sample container according to any one of claims 1-20, wherein when nested, an annular region bounded by at least a portion of the external surface of the inner container and at least a portion of the internal surface of the outer container forms an annular gap.

22. The sample container of claim 21 , wherein the external surface of the inner container is an external surface of the at least one sidewall.

23. The sample container of claim 21 or 22, wherein the indicator is within the annular gap.

24. The sample container according to any one of claims 21-23, wherein the indicator is couplable to the external surface of the inner container.

25. The sample container according to any one of claims 1-24, wherein the indicator is configured to test the fluid sample for at least one indication.

26. The sample container according to any one of claims 1-25, wherein the indicator is configured to activate upon contact with at least a portion of the fluid sample.

27. The sample container according to any one of claims 1-26, further comprising an indicator support.

28. The sample container of claim 27, wherein the indicator support is shaped to correspond to the outer circumference of the inner container.

29. The sample container according to any one of claims 1-28, wherein the indicator comprises a paper or plastic indicator strip.

30. The sample container according to any one of claims 1-29, wherein when nested, the sidewalls of the inner and outer containers meet at at least one junction to produce a seal.

31. The sample container of claim 30, wherein the seal is produced using a sealer.

32. The sample container of claim 31 , wherein the sealer is a sealing ring, a gasket, a threaded connection, and / or an O-ring.

33. The sample container according to any one of claims 1-32, wherein the indicator comprises paper, plastic, an indicator pad, a sponge, a dye, a powder, or a film.

34. The sample container according to any one of claims 1-33, wherein the inner container defines an opening opposite the bottom wall, and wherein the inner container further comprises a lid configured to cover the opening.

35. The sample container of claim 34, wherein the lid comprises a sealing gasket to create a fluid-tight seal when the lid covers the opening.

36. A method, comprising: introducing a fluid sample into an inner container of a sample container, the inner container nestable and twistable relative to an outer container, the bottom wall of the inner container forming at least one aperture; and twisting the inner container relative to the outer container to establish fluidcommunication between the inner container and the outer container through the at least one aperture to allow at least a portion of the fluid sample to contact an indicator located between the inner and outer containers.

37. The method of claim 36, wherein the twisting is about the central axis of the inner container.

38. The method of claim 36 or 37, wherein the twisting moves the inner container towards or away from the outer container.

39. The method of claim 36 or 37, wherein the twisting moves the inner container towards or away from the outer container along the central axis.

40. The method of claim 38 or 39, wherein moving the inner container away from the outer container establishes fluid communication between the inner and outer container.

41. The method according to any one of claims 38-40, wherein moving the inner container towards the outer container seals the at least one aperture.

42. The method according to any one of claims 38-41 , wherein the inner container is movable towards the outer container to physically engage the outer container at at least the portion forming the at least one aperture.

43. The method according to any one of claims 38-42, wherein the inner container is movable away from the outer container to create an annular gap between the inner and outer containers at at least the portion forming the at least one aperture.

44. The method according to any one of claims 36-43, wherein the inner container is nestable concentrically with the outer container.

45. The method according to any one of claims 36-44, wherein the twisting comprises securing the inner container in at least one position relative to the outer container.

46. The method of claim 45, wherein one position establishes fluid communication between the inner container and the outer container.

47. The method of claim 45 or 46, wherein another position seals the at least one aperture.

48. The method according to any one of claims 36-47, wherein the totality of fluid communication between the inner container and the outer container is through the at least one aperture.

49. The method according to any one of claims 36-48, further comprising contacting the indicator with at least a portion of the fluid sample.

50. The method of claim 49, wherein the indicator is contacted by at least a portion of the fluid sample by pivoting the sample container around a point or along an edge thereof.

51. The method of claim 50, wherein the point is on the central axis.

52. The method according to any one of claims 36-51 , wherein when nested, the sidewalls of the inner and outer containers meet at at least one junction to produce a seal.

53. The method according to any one of claims 36-52, further comprising sealing the fluid sample within the inner container.

54. The method according to any one of claims 36-53 using the sample container according to any one of claims 1-35.

55. The sample container according to any one of claims 1-35 or the method according to any one of claims 36-54, wherein the fluid sample is a blood sample, a urine sample, a peritoneal fluid sample, a pericardial fluid sample, a pleural fluid sample, a synovial fluid sample, a cerebrospinal fluid sample, an amniotic fluid sample, a saliva sample, semen sample, and / or a cervical mucus sample.

6. The sample container according to any one of claims 1-35 or the method according to any one of claims 36-54, wherein the fluid sample is a water sample, a wastewater sample, an air sample, a hydraulic fluid sample, an engine oil sample, a coolant sample, a chemical solvent sample, or a liquid fuel sample.

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