Flushable chromatographic urine tester and method

Abstract

A flushable apparatus (10) for testing a liquid specimen such as urine for a condition such as pregnancy. The apparatus includes a pliable sheet (11) that can be secured to the rim of a toilet bowl. The sheet is shaped and dimensioned to cause a flow of urine to impact a testing unit (30) such as a pH indicator patch, a biodegradable immunoassay, a metal organic framework composite containing assay, or a removable, non-flushable chromatographic strip, and to dram excess urine away from the testing unit. The apparatus can be disposed of in a convenient, environmentally responsible way. The testing unit can provide results in a color-coded manner that can be easier to read by inexperienced users.

Description

Flushable chromatographic urine tester and methodPrior Application

[0001] This application claims the benefit of US Provisional Patent Application Serial No. 63720431, filed 2024-11-14 incorporated herein by reference.Field of the Invention

[0002] This invention relates to fluid testing and more particularly to preliminary screening of bodily fluids, such as urine, to detect various conditions such as pregnancy.Background of the Invention

[0003] Liquid specimen diagnostic testing devices are commonly used to collect and test liquid specimens such as bodily fluids such as urine for the presence or absence of specific "indicators" which show the presence of certain chemicals, hormones, antibodies or antigens associated with various physiological conditions and are commonly used to indicate pregnancy status, detect various diseases, and screen for drugs of abuse. Such devices commonly use immunoassay techniques to detect the indicators.

[0004] In many cases, an immunoassay test device can include a porous strip testing unit which drives the specimen along a path where the specimen is first exposed to a mobilized binding member, conjugated to a visually detectable label such as colloidal gold, that can bind to an analyte in the specimen which is specific to the condition being tested. The specimen including its labeled analytes then flows onward past a region of immobilized binding members upon which the labeled analytes can accumulate.Accumulation of labeled analytes in sufficient numbers can signal the test result in a chromatographic manner. One problem with such strip-type testing units is that the signal is often a weakly appearing line which may be difficult for some people to perceive. Another problem is the use of a control line to ensure the validity of the test. This creates multiple result scenarios including no lines, one of the two lines, or both lines which can confuse some users.

[0005] Immunoassay rapid test devices have been adapted for in-home use. For example, devices such as shown in May et al., US Pat. No. 5602040 provide for testing urine specimens among other possible specimens. A testing strip can be mounted within ahousing grasped by the donor and held within a stream of urine to initiate the test.Conducting such tests can be difficult and / or distasteful for the donor, can often result in splashing of urine onto the hands or legs, and can be difficult for users to determine the proper amount of urine and / or duration of exposure. In addition, such devices are often made of single use plastics which have been found to be an environmental hazard.

[0006] In order to reduce the volume of single-use plastics, efforts have been made to provide biodegradable components on preliminary screening test devices. For example, devices such as shown in Edwards et al., US Pat. No. 11911771 attempt to provide components made from materials which can be water dispersible, flushable, biodegradable, compostable, and / or water-soluble. It is recognized that many chromatographic test strips use non- water-soluble nitrocellulose membranes and a plastic backing.

[0007] Collectors for solid specimens such as feces or stools have been proposed in an attempt to reduce contact with donors. For example, Stover et al., US Pat. No. 4445235 provides a receptacle which spans a toilet seat and is oriented to trap the solid stool while allowing urine to pass through a plurality of holes. Adhesive pads are provided to allow the receptacle to be temporarily secured to the toilet seat in an effective location.

[0008] The pH of a urine specimen can be used to detect various health-related conditions such as kidney malfunction, urinary tract infections, dietary problems, or whether the donor is taking certain drugs. Testing the pH of a urine specimen can often include exposing a testing unit in the form of a paper pH indicator strip to the urine. The color of the indicator strip can be used to indicate a range of pH values by comparing the color with color swatches each associated with a particular range of values. Paper based pH indicators such as Hydrion brand indicators are commercially available from Micro Essential Laboratory Inc of Brooklyn, New York. The advantage of a color- based indicator testing units is that it would avoid the confusion associated with control lines and potential weak signaling of many common chromatographic testing units.

[0009] Metal-organic frameworks (MOF) have been proposed for use as a biosensor for detecting the presence of specific viral sequences for Influenza A and B as described in Rapid Detection of Viruses via Metal Organic Frameworks (MOFs), New Mexico EPSCoR, October 2023.

[0010] Because preliminary screening tests are being performed and evaluated by relatively unskilled members of the general public, preliminary rapid screening devices need to be relatively simple to operate to ensure adequate exposure of the testing unit and to provide more consistent results.

[0011] Therefore, there is a need for a liquid specimen test device which addresses some or all of the above identified inadequacies,

[0012] The instant invention results from efforts to provide an improved preliminary fluid specimen testing system which addresses one or more of the above problems.Summary

[0013] The primary and secondary objects of the claimed invention are to provide a simple to use and environmentally friendly bodily fluid testing apparatus.

[0014] These and other objects are achieved by a piece of flushable material carrying a testing unit responsive to at least one analyte present in an amount of fluid specimen from a donor.

[0015] In some embodiments there is a provided an apparatus which comprises: a sheet of pliable, flushable, biodegradable material having an upper surface and a lower surface; wherein the sheet has a length dimension and a width dimension; wherein the sheet has a front edge and a back edge separated by the length dimension; wherein the sheet has a pair of opposite lateral side edges separated by the width dimension; wherein the width dimension is selected to allow the sheet to span a central hole of a common toilet bowl; wherein the sheet is shaped to have a medial concave depression in the upper surface; wherein the depression is shaped to direct a flow of liquid toward an aperture; wherein the aperture is located within the depression; a testing unit located adjacent to said aperture; wherein the testing unit is made from a flushable, biodegradable material; wherein the testing unit is visually responsive to the presence of liquid containing components indicating a condition being tested for.

[0016] In some embodiments there is a provided an apparatus for testing a liquid specimen, the apparatus comprises: a support structure; wherein said support structure is biodegradable; a testing unit responsive to an analyte in an amount of said liquid; wherein said testing unit is secured to the support structure; wherein said support structure comprises: a first surface oriented to capture said amount falling under the force ofgravity; a channel directing the amount from said surface toward the testing unit; and, a drain adjacent to said testing unit.

[0017] In some embodiments said support structure comprises: a sheet of pliable, flushable, biodegradable material having an upper surface and a lower surface; wherein the sheet has a length dimension and a width dimension; wherein the sheet has a front edge and a back edge separated by the length dimension; wherein the sheet has a pair of opposite lateral side edges separated by the width dimension; wherein the width dimension is selected to allow the sheet to span a central hole of a common toilet bowl; wherein the sheet is shaped to have a medial concave depression in the upper surface; wherein the depression is shaped to direct a flow of liquid toward an aperture forming said drain; wherein the aperture is located within the depression; wherein said testing unit is located adjacent to said aperture; wherein the testing unit is made from a flushable, biodegradable material; wherein the testing unit is visually responsive to the presence of liquid containing components indicating a condition being tested for.

[0018] In some embodiments the width dimension is between 20cm and 50cm.

[0019] In some embodiments the depression has a backwardly descending slope from the front edge toward the aperture; wherein the slope is at an angle to the horizontal; and, wherein the angle is between 5 degrees and 45 degrees.

[0020] In some embodiments the testing unit is visually responsive in a color-coded manner.

[0021] In some embodiments the testing unit comprises a paper pH indicator.

[0022] In some embodiments the testing unit comprises a metal-organic framework (MOF) composite.

[0023] In some embodiments the testing unit comprises an immunoassay for detecting a female hormone.

[0024] In some embodiments the testing unit is an immunoassay comprising cellulose nanobeads.

[0025] In some embodiments said apparatus further comprises a placard visibly located on the support structure; and wherein the placard includes colored swatches corresponding to the color of the result of the testing unit.

[0026] In some embodiments the depression is funnel shaped, and wherein the testing unit is located at the bottom of the depression; and wherein the aperture is one of a plurality of apertures surrounding said testing unit.

[0027] In some embodiments the sheet is wrapped into an oblong handle.

[0028] In some embodiments the apparatus further comprises: a paddle extending from a distal end of said handle; wherein said testing unit is secured to an upper surface of said paddle.

[0029] In some embodiments the support structure loses structural rigidity within 45 seconds of being immersed in water.

[0030] In some embodiments the support structure retains 95% of its structural rigidity for at least 20 seconds when the support structure is immersed in water.

[0031] In some embodiments said support structure comprises: a handle; a paddle extending from a distal end of said handle; wherein said testing unit is secured to an upper surface of said paddle.

[0032] In some embodiments there is a provided a method for conducting a preliminary screening test a urine specimen, said method comprises: selecting a flushable test apparatus carrying a testing unit visually responsive to a condition being tested; adhering the test apparatus to a toilet; urinating on the test apparatus; observing the testing unit for a color; comparing the color against colored swatches corresponding to different results to obtain a result; and flushing the apparatus down the toilet.

[0033] In some embodiments said method further comprises: removing the testing unit prior to said flushing.

[0034] The content of the original claims is incorporated herein by reference as summarizing features in one or more exemplary embodiments.Brief Description of the Drawings

[0035] Fig. 1 is a diagrammatical perspective illustration of a toilet including a preliminary urine screening apparatus secured thereto.

[0036] Fig. 2 is a diagrammatical perspective illustration of a preliminary urine screening apparatus according to an exemplary embodiment of the invention.

[0037] Fig. 3 is a partial cross-sectional side view of the apparatus of Fig. 2 taken along line 3 — 3.

[0038] Fig. 4 is a diagrammatic top view of the apparatus of Fig. 2.

[0039] Fig. 5 is a partial cross-sectional side view of a preliminary' urine screening apparatus according to an alternate embodiment having a removable, non-flushable testing unit strip.

[0040] Fig. 6 is a diagrammatical perspective illustration of a preliminary urine screening apparatus having a central testing unit in the bottom of a depression.

[0041] Fig. 7 is a diagrammatic top view of a preliminary urine screening apparatus according to an alternate embodiment of the invention having a planar configuration,

[0042] Fig. 8 is a diagrammatical perspective illustration of a preliminary urine screening apparatus having a flushable wound paper handle.

[0043] Fig. 9 is a cross-sectional side view of the apparatus of Fig. 8 taken along line 9 — 9.

[0044] Fig. 10 is a diagrammatical perspective illustration of a preliminary urine screening apparatus made from starch-based biodegradable foam.

[0045] Fig. 11 is a diagrammatical perspective illustration of the support paddle made from starch-based biodegradable foam.

[0046] Fig. 12 is a flow chart block diagram of a method for conducting preliminary¬ urine screening test according to an exemplary embodiment of the invention.Description of the Exemplary Embodiments

[0047] In this specification, the references to top, bottom, upward, downward, upper, lower, vertical, horizontal, sideways, lateral, back, front, proximal, distal, etc. can be used to provide a clear frame of reference for the various structures when the sheet is oriented upright on a typical toilet seat oriented perpendicular to the force of Earth’s gravity', and not treated as absolutes when the frame of reference is changed, or when the sheet is oriented differently.

[0048] If used in this specification, the term “substantially” can be used because manufacturing and assembly imprecision and inaccuracies can lead to non-symmetricity and other inexactitudes in the shape, dimensioning and orientation of various structures. Further, use of “substantially” in connection with certain geometrical shapes, such as “planar”, “conical”, “triangular”, “wedge-shaped” and “cylindrical”, and orientations, such as “parallel” and “perpendicular”, can be given as a guide to generally describe thefunction of various structures, and to allow for slight departures from exact mathematical geometrical shapes and orientations, while providing adequately similar function. Those skilled in the art will readily appreciate the degree to which a departure can be made from the mathematically exact geometrical references.

[0049] If used in this specification, the word “axial” is meant to refer to directions, movement, or forces acting substantially parallel with or along a respective axis, and not to refer to rotational nor radial nor angular directions, movement or forces, nor torsional forces,

[0050] In this specification the units “millimeter” or “millimeters” can be abbreviated “mm”, “centimeter” or “centimeters” can be abbreviated “cm”, and “milligram” or “milligrams” can be abbreviated “mg”. Units of temperature such as “degrees centigrade” can be abbreviated “PC”.

[0051] The following description will describe the exemplary embodiments primarily in connection with the testing of an amount of urine to make a preliminary determination of a pregnancy condition of the donor. However, those skilled in the art of bodily fluid testing will readily appreciate the applicability of the embodiments to other testing of other fluids for medical conditions such as urinary tract infection, and other various types of testing such as environmental testing.

[0052] In this specification use of the term “flushable” is meant to refer to an item that is both biodegradable, non-hazardous and water soluble within an amount of time that allows it to be flushed in a standard, commercially available consumer toilet. Thus, the term is consistent with the use of the term in Edwards et al., US Pat. No. 11911771, incorporated herein by reference, which attempts to provide components made from materials which can be water dispersible, flushable, biodegradable, or water-soluble.

[0053] Referring now to the drawing, there is shown in Figs. 1-4 an environmentally friendly bodily fluid testing apparatus 10 including a support structure such as a sheet 11 made from a biodegradable, flushable material such as waxed paper. The sheet can be shaped and dimensioned to droopingly span the top opening 3 of a typical toilet bowl 2. The sheet can be substantially quadrangular having a top surface 12 substantially parallel to a bottom surface 13 providing the sheet with a substantially uniform thickness. The sheet can have a front edge 14 and a substantially parallel back edge 15 separated by alength dimension L. A pair of substantially parallel lateral side edges 16,17 are separated by a width dimension W. The width can be selected to cause a medial concave depression in the upper surface, in other words a central droop. The width dimension can typically be between 20cm and 50cm. The sheet can be releasably secured to the toilet bowl rim by a pair of adhesive patches 18,19 located on the bottom surface near the side edges.

[0054] The center drooping portion of the sheet 11 can be shaped to have a central, downwardly extending funnel, terminating in a central drainage aperture or dram 21 dimensioned to allow' a flow of urine to pass therethrough. The funnel can be formed in the sheet by a number of pleats 22a-22e. A front pair of the pleats 22d,22e can be substantially parallel to form a channel 23 which slopes downwardly toward the central drainage aperture. The channel can support a testing unit 30 such as a pH testing paper, responsive to an analyte in question such as an acid or base molecule. The testing unit can be secured by an amount of flushable adhesive 31 such as white glue.

[0055] The shape and positioning of the pleats 22a-22e can be selected to provide a front slope angle Al of between 5 and 45 degrees, and a back slope angle A2 of between 5 and 45 degrees. Similarly, the shape and dimensioning of the drainage aperture 21, including its diameter DI can be selected to cooperate with the funnel shape to provide rapid movement of urine toward the drainage aperture while still providing an adequate duration of exposure of the testing unit 30. In this way the support structure 11 provides a top surface 12 oriented to capture the urine falling under the force of gravity, and to direct the urine along the channel 23 toward the testing unit 30 and on toward the adjacent downstream drain 21. Further, in this way the testing unit can be visually responsive to the presence of liquid, such as urine, containing components or analytes, such as an acid or basic character molecules, indicating a condition being tested.

[0056] A color-coded placard 33 can be imprinted upon a portion of the upper surface 12 of the sheet 11 where the sheet is expected to stay dry. In this way the colors will not be shifted by the presence of wetness. The placard can include a number of different color swatches 34 indicating the colors of the liquid exposed testing unit 30 corresponding to the various possible results.

[0057] It shall be understood that the pH paper testing unit can be replaced with a graphical immunoassay testing unit that is biodegradable such as the cellulose nanobead-based units commercially available from Asahi Kasei Pharma Corporation of Tokyo, Japan. Further, the testing unit can include a metal-organic framework (MOF) composite adapted to detect one or more specific analytes indicating the condition being tested.

[0058] Alternately, as shown in Fig. 5 a non-flushable immunoassay testing strip 40 can be used as the testing unit in the above embodiment. The strip can be secured to the sheet 11 using a releasable flushable adhesive 43. In this way the testing unit can be visually responsive to the presence of liquid, such as urine, containing components, such as pregnancy related analytes, such as certain female hormones including human chorionic gonadotropin (hCG), progesterone, and / or estrogen indicating a condition, such as pregnancy.

[0059] The strip 40 can include a pull-tab 41 at its upper end that is to remain out of the flow of urine so that the user can grasp and remove it prior to flushing the sheet. This allows for the user to retain evidence of the test result while disposing of the remainder of the test apparatus in a convenient, environmentally responsible manner.

[0060] Fig. 6 shows an alternate embodiment of an environmentally friendly bodily fluid testing apparatus 50 similar to the embodiment of Figs. 1-4, but with a testing unit 52 such as a patch of pH responsive material located at the bottom of the funnel structure. The testing unit can be surrounded by a number of drainage apertures 53a- 53d, each of which extend through the sheet from its top surface 54 to its bottom surface 55. The shape and dimensioning of the drainage apertures, and their location with respect to the testing unit, and the slopes of the funnel can be selected to provide rapid movement of urine toward the testing unit while rapidly draining excess urine from the apparatus.

[0061] Fig. 7 shows an alternate embodiment of an environmentally friendly bodily fluid testing apparatus 60 similar to the embodiment of Fig. 6, but manufactured in a completely flat manner. The testing unit 61 can be located in the central area of the sheet. Similar to the earlier embodiments, the width W2 of the sheet is selected so that the central area droops downwardly. In addition, the adhesive patches 68,69 can each be canted inwardly at an angle A3 toward the front 64 of the sheet. This causes the user to attempt to align the patches with the opposite edges of the bowl. That attempt causes the rear edge 65 of the sheet to droop downwardly more than the front edge. In this way liquid impacting the sheet nearer the front edge is driven toward the back edge, passingover the testing unit. The angle can preferably range between about 2 and 30 degrees. Further, the testing unit can be surrounded by a number of drainage apertures 63a-63f, extending through the sheet from the top surface to the bottom surface. In this way the sheet can accommodate a high volume of liquid being rapidly drained from the apparatus.

[0062] Figs. 8-9 show an alternate embodiment of an environmentally friendly bodily fluid testing apparatus 70 which includes a support structure including a handle 71 having a distal end 72 which supports a paddle 73 upon which is supported a testing unit 74. The user can grasp the handle and hold the testing unit under a stream of urine for a period of time in order to conduct the test. After observing the result the user can then drop the apparatus into the toilet and flush it. The handle can be made of a sheet of water-soluble paper wound in a spiral. In this way the handle maintains its rigidity while conducting the test but rapidly loses that rigidity when immersed in water. For example, the thickness and number of windings of the handle along with other parameters such as material tightness of windings, length and diameter of the handle can be selected to allow the handle to maintain 95% of its structural rigidity for at least 20 seconds when the support structure is immersed in water. Further, these parameters can be selected so that the support structure loses its structural rigidity within 45 seconds of being immersed in water so that it may be flushable.

[0063] The type of testing unit can be selected from those that are flushable such as a paper pH indicator. Alternately, the testing unit can be a biodegradable chromatographic immunoassay made using cellulose nanobeads, such as those commercially available from Asahi Kasei Pharma Corporation of Tokyo, Japan.

[0064] Figs. 10-11 show an alternate embodiment of an environmentally friendly bodily fluid testing apparatus 80 similar to the embodiment of Figs. 8-9, but which includes a support structure, including handle 81 and a support paddle 83 at the distal end 82 of the handle all made from a starch-based biodegradable foam commercially available from Polycell Packaging Corp, of Cerritos, California. The support paddle carries a testing unit 84.

[0065] Fig. 12 shows a method 100 for conducting a preliminary screening test a urine specimen according to an exemplary embodiment of the invention. The method can include first selecting 101 a flushable test apparatus that carries a testing unit visuallyresponsive to a condition being tested, such as pregnancy. The user can adhere 102 the test apparatus to a toilet before urinating 103 onto the test apparatus. The urine reacts with the testing unit during the test. Once the reaction is complete, the user can observe 104 the testing unit for a color. The user can then compare 105 the color against colored swatches corresponding to different results to obtain a result. Once the result is obtained the user can flush 106 the entire apparatus down the toilet.

[0066] While the preferred embodiment of the invention has been described, modifications can be made and other embodiments may be devised without departing from the spirit of the invention and the scope of the appended claims.

Claims

CLAIMS1. An apparatus for testing a liquid specimen, the apparatus comprises:a support structure;wherein said support structure is biodegradable;a testing unit responsive to an analyte in an amount of said liquid;wherein said testing unit is secured to the support structure;wherein said support structure comprises:a first surface oriented to capture said amount falling under the force of gravity;a channel directing the amount from said surface toward the testing unit; and,a drain adjacent to said testing unit.

2. The apparatus of Claim 1, wherein said support structure comprises:a sheet of pliable, flushable, biodegradable material having an upper surface and a lower surface;wherein the sheet has a length dimension and a width dimension;wherein the sheet has a front edge and a back edge separated by the length dimension;wherein the sheet has a pair of opposite lateral side edges separated by the width dimension;wherein the width dimension is selected to allow the sheet to span a central hole of a common toilet bowl;wherein the sheet is shaped to have a medial concave depression in the upper surface;wherein the depression is shaped to direct a flow of liquid toward an aperture forming said drain;wherein the aperture is located within the depression;wherein said testing unit is located adjacent to said aperture;wherein the testing unit is made from a flushable, biodegradable material; wherein the testing unit is visually responsive to the presence of liquid containing components indicating a condition being tested for.

3. The apparatus of Claim 2, wherein the width dimension is between 20cm and 50cm.

4. The apparatus of Claim 2, wherein the depression has a backwardly descending slope from the front edge toward the aperture; wherein the slope is at an angle to the horizontal; and, wherein the angle is between 5 degrees and 45 degrees.

5. The apparatus of Claim 1, wherein the testing unit is visually responsive in a color-coded manner.

6. The apparatus of Claim 1, wherein the testing unit comprises a paper pH indicator.

7. The apparatus of Claim 1, wherein the testing unit comprises a metal-organic framework (MOF) composite.

8. The apparatus of Claim 1, wherein the testing unit comprises an immunoassay for detecting a female hormone.

9. The apparatus of Claim 1, wherein the testing unit is an immunoassay comprising cellulose nanobeads.

10. The apparatus of Claim 1, wherein said apparatus further comprises a placard visibly located on the support structure; and wherein the placard includes colored swatches corresponding to the color of the result of the testing unit.

11. The apparatus of Claim 2, wherein the depression is funnel shaped, and wherein the testing unit is located at the bottom of the depression; and wherein the aperture is one of a plurality of apertures surrounding said testing unit.

12. The apparatus of Claim 2, wherein the sheet is wrapped into an oblong handle.

13. The apparatus of Claim 12, which further comprises:a paddle extending from a distal end of said handle;wherein said testing unit is secured to an upper surface of said paddle.

14. The apparatus of Claim 1, wherein the support structure loses structural rigidity within 45 seconds of being immersed in water.

15. The apparatus of Claim 1, wherein the support structure retains 95% of its structural rigidity for at least 20 seconds when the support structure is immersed in water.

16. The apparatus of Claim 1, wherein said support structure comprises:a handle;a paddle extending from a distal end of said handle;wherein said testing unit is secured to an upper surface of said paddle.

17. A method for conducting a preliminary screening test a urine specimen, said method comprises:selecting a flushable test apparatus carrying a testing unit visually responsive to a condition being tested;adhering the test apparatus to a toilet;urinating on the test apparatus;observing the testing unit for a color;comparing the color against colored swatches corresponding to different results to obtain a result; andflushing the apparatus down the toilet.

18. The method of Claim 15, which further comprises:removing the testing unit prior to said flushing.

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