COPYRIGHT NOTICE

[0001] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the United States Patent and Trademark Office patent file or records, but otherwise reserves all copyright rights whatsoever. CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This international patent application claims benefit and priority to US utility patent application No. 15/943,549, filed on April 2, 2018, titled: "FEMALE URINE STRAINERS AND SAMPLERS", which in turn claims benefit and priority to US provisional patent application No. 62/489,251 filed on April 24, 2017, titled “FEMALE URINE STRAINER”, the contents of all of which are incorporated by reference as if fully set forth herein for all purposes.

BACKGROUND OF THE INVENTION

[0003] Field of the Invention: The present invention relates generally to urine samplers. More particularly, this invention relates to disposable hand-held urine samplers for use by anyone that needs to produce a urine sample.

[0004] Description of Related Art: The process for obtaining a urine sample from a patient typically involves a medical professional providing a urine sample cup that has a cap that screws onto the top rim of the cup and provides for safe transportation of the urine sample once delivered. The patient is left to dispense a limited stream of urine into the cup and secure the lid upon the cup after dispensing the urine. This task is complicated by a preference for a "clean catch" of the urine, i.e., initiating urination for a brief duration, stopping the stream of urine long enough to place the open cup in the path of the urine stream (or simply introducing the open cup to the initiated urine stream) and then stopping the urine stream (or removing the cup from the urine stream) once the desired measure of urine has been obtained and then capping the cup. As one can imagine from the process description above, there are multiple opportunities to deliver the urine in undesirable locations, e.g., outside surface of the cup, on the fingers, hands, and/or thighs of the patient, on the floor or walls, etc.

[0005] Additionally, one can further imagine that it is much easier for men to direct a urine stream into a sample cup than it is for women. Merely obtaining a urine sample presents difficulties for men, and particularly women, for these reasons. Accordingly, there exists a need in the art for improved urine samplers, particularly samplers better suited for use by female patients.

BRIEF SUMMARY OF THE INVENTION

[0006] The present invention includes embodiments of disposable urine samplers which are used to obtain urine samples. The embodiments of disposable urine samplers generally include a handle leading to a urine cup receptacle. The embodiments of urine samplers disclosed herein may be used by patients who have been instructed, or otherwise need, to produce a urine sample in a urine sample cup. The embodiments of urine samplers disclosed herein help prevent accidental urination on the hands or fingers of the user during the urine sampling process.

[0007] The embodiments of urine samplers disclosed herein are particularly adapted for use by female patients, though male patients may also use the devices. Because each embodiment disclosed may be used by either gender, they may find universal application as urine samplers. The urine samplers disclosed herein are thus advantageous over conventional samplers that are available in the market to date, which are generally more convenient for use by male patients.

[0008] Additional features and advantages of the invention will be apparent from the detailed description which follows, taken in conjunction with the accompanying drawings, which together illustrate, by way of example, features of embodiments of the present invention.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0009] The following drawings illustrate exemplary embodiments for carrying out the invention. Like reference numerals refer to like parts in different views or embodiments of the present invention in the drawings. [0010] FIG. 1 is a perspective image of a first embodiment of a disposable hand-held urine sampler, according to the present invention.

[0011] FIG. 2 is a close-up side image of a second embodiment of a disposable hand-held urine sampler illustrating a specimen cup with fluid therein as it would be immediately after use, according to the present invention.

[0012] FIG. 3 is a top image of the first embodiment of a disposable hand-held urine sampler, according to the present invention.

[0013] FIG. 4 is a side image of the first embodiment of a disposable hand-held urine sampler, according to the present invention.

[0014] FIG. 5 is a top front image of the first embodiment of a disposable hand held urine sampler with specimen cup inserted and cap removed, according to the present invention.

[0015] FIG. 6 is a side image of the first embodiment of a disposable hand-held urine sampler with specimen cup with cap installed and inserted, according to the present invention.

[0016] FIG. 7 A is a plan view of an embodiment of a pattern for a disposable hand-held urine sampler, according to the present invention.

[0017] FIG. 7B illustrates an image of the pattern shown in FIG. 7A after it has been cut from lightweight milled paper or cardboard, according to the present invention.

[0018] FIG. 7C illustrates a perspective image of the embodiment of the disposable hand-held urine sampler shown in FIGS. 7A and 7B, folded with a urine sample cup placed through first and second circular openings, according to the present invention.

[0019] FIG. 7D illustrates another perspective image of the embodiment of the disposable hand-held urine sampler shown in FIGS. 7A-7C, completely folded and ready to use with urine sample cup cap removed.

[0020] FIG. 8A is a plan view of another embodiment of a disposable hand-held- urine sampler, according to the present invention.

[0021] FIG. 8B is a perspective view of the embodiment of the disposable hand- held-urine sampler shown in FIG. 8A, according to the present invention.

[0022] FIG. 8C is a top view of the disposable hand-held-urine sampler shown in FIGS. 8A and 8B, folded flat, according to the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0023] Embodiments of the present invention include disposable urine samplers that may be used with conventional urine sample cups to gather urine from a patient for content analysis. The embodiments of urine samplers disclosed herein are particularly adapted for use by female patients, but may also be used by male patients.

[0024] The structural features of the various embodiments of urine samplers disclosed herein may be used with a variety of conventional urine sample cups having a variety of capacities and cylindrical diameters, for example and not by way of limitation: ClikSeal™ brand specimen containers, part number, 02058, 4oz/120mL capacity, and part number 02057, 3oz/120mL capacity, light blue cap, both available from Medegen Medical Products, 209 Medegen Drive, Gallaway, TN, 38036, USA; BD Vacutainer® brand specimen containers, reference number 364975, 4.5oz/120mL, dark blue cap, available from Becton, Dickinson and

Company, 1 Becton Drive, Franklin Lakes, NJ 07417, USA; CardinalHealth™ sterile specimen containers, e.g., catalog number CHB13902, 90mL/55mm sterile and catalog number CHB13903, 120mL/55mm sterile, orange cap, both available from CardinalHealth™, 7000 Cardinal Place, Dublin, OH 43017, USA.

[0025] FIG. 1 is a perspective image of a first embodiment of a disposable hand-held urine sampler 100, according to the present invention. The sampler 100 may include a planar handle 102 having proximate 104 and distal 106 ends. The sampler 100 may further include a bottom cup holder panel 108 having a first edge 1 10 attached to, and extending from, the distal end 106 of the handle 102. The bottom cup holder panel 108 may further include a second edge 1 12 opposite the first edgel 10. The sampler 100 may further include an upper cup holder panel 1 14 having a third edge 1 16 attached to, and extending from the handle 102. The upper cup holder panel 1 14 may further include a fourth edge 1 18 opposite the third edge 1 16. The upper cup holder panel 1 14 may be disposed parallel to the bottom cup holder panel 108. The sampler 100 may further include a bridge panel 120 (not shown in FIG. 1 , but see, e.g., FIG. 4) attached to, and extending between, the second edge 1 12 and the fourth edge 1 18. [0026] Another embodiment of a disposable hand-held urine sampler may further include a hole 122 disposed through the handle 102 at a location closer to the proximate end 104 versus the distal end 106. Hole 122 may be used to hang multiple samplers 100 on a post for storage or easy access when dispensing to patients.

[0027] Embodiments of a disposable hand-held urine sampler 100 may further include a first circular opening 124 disposed in the bottom cup holder panel 108. The first circular opening 124 may having a diameter, d. The first circular opening 124 may define a bottom rim 124A. Bottom rim 124A may be located between the first 1 10 and second 1 12 edges as shown, e.g., in FIG. 1. Embodiments of a disposable hand-held urine sampler 100 may further include a second circular opening 126 disposed in the upper cup holder panel 1 14. The second circular opening 126 may also have diameter, d. The second circular opening 126 may also define an upper rim 126A located between the third 1 16 and fourth 1 18 edges.

[0028] FIG. 2 is a close-up side image of a second embodiment of a disposable hand-held urine sampler 200 illustrating a specimen cup 500 with fluid therein as it would be immediately after use, according to the present invention. Sampler 200 may include a handle 202, bottom cup holder panel 208, upper cup holder panel, 214 and bridge panel 220 that form a parallelogram structure 240 supporting the loaded cup 500. Note that sampler 200 includes a first circular opening 224, bottom rim 224A, second circular opening 226 and upper rim 226A. However, sampler 200 does not include any additional special features on the upper rim 226A.

[0029] As shown in FIG. 2, the embodiment of a disposable hand-held urine sampler 200 may be used to support a cylindrical specimen cup 500. The cylindrical specimen cup 500 may include a threaded opening 504 for receiving a cap (not shown in FIG. 2, but see, e.g., 502 in FIG. 6), a closed bottom 506 and a body diameter slightly less than d, and a shoulder rim 508 greater than d, wherein the closed bottom 506 is configured to pass through the second circular opening 226 and then through the first circular opening 224 with the shoulder rim 508 resting upon the upper rim 226A during use. [0030] An important feature of all of the samplers disclosed herein is illustrated in FIG. 2. When the cup is filled as shown in FIG. 2, the weight of the cup and fluid tends to bend the sampler 200 downward because of the force of gravity. The parallelogram structure 240 (also 140) applies an outward force, f (see arrow) at bottom rim 224A and an inward force f _å (see arrow) at upper rim 226A, thus, holding the cup 500 in place and preventing it from tipping and spilling. Without this parallelogram structure 240 (also 140), the cup would bend the sampler 200 and the contents would spill out.

[0031] FIG. 3 is a top image of the first embodiment of a disposable hand-held urine sampler 100 shown in greater magnification, according to the present invention. As best shown in FIG. 3, embodiments of a disposable hand-held urine sampler 100 may further include radial cuts 128 disposed evenly along the upper rim 126A formed in the second circular opening 126. Adjacent radial cuts 128 form a bendable tab located there between. Each bendable tab 130 may extend from the upper rim 126A to a virtual rim 132 having a diameter, D, where D > d.

[0032] Another embodiment of a disposable hand-held urine sampler 100 may further include partial cuts 134 formed along the virtual rim 132 and between the radial cuts 128, thereby forming removable, or break-away, tabs 130, as shown best in FIGS. 3 and 4. Thus, the bendable tabs 130 formed by radial cuts 128 may be converted to removable, or breakaway tabs 130 by the addition of partial cuts 134 along the tabs130 opposite the upper rim 126A.

[0033] FIG. 4 is a side image of the first embodiment of a disposable hand-held urine sampler 100, according to the present invention. As shown in FIG. 4, the handle 102, bottom cup holder panel 108, bridge panel 120 and upper cup holder panel 1 14 form a parallelogram 140 that structurally supports a specimen cup (not shown in FIG. 4) when inserted for use. FIG. 4 also illustrates how the bendable tabs may become removable, or breakaway, tabs 130 by use of radial 128 and partial 134 cuts in the upper rim 126A of the second circular opening, located in the upper cup holder panel 1 14. Note that the tabs 130 are configured to bend down toward the bottom cup holder panel 108. [0034] FIG. 5 is a top front image of the first embodiment of a disposable hand held urine sampler 100 with specimen cup 500 inserted and cap 502 removed, according to the present invention. The specimen cup 500 may include a threaded rim 504 mated to threads inside lid 502.

[0035] FIG. 6 is a side image of the first embodiment of a disposable hand-held urine sampler 100 with specimen cup 500 including cap 502 installed and inserted, according to the present invention. FIG. 6 also illustrates the

parallelogram 140 formed by the handle 102, bottom cup holder panel 108, bridge panel 120 and upper cup holder panel 1 14, which structurally supports the cup 500 during use. The parallelogram structure 140 prevents the cup 500 from folding the handle 102 and spilling the contents of the cup 500, even when full of a specimen fluid (urine, etc.) As shown in FIG. 6, the bendable tabs 130 allow some flexibility in cup 500 diameter (ranging from to D, see FIG. 3).

[0036] According to another embodiment, the disposable hand-held urine sampler may further be configured to be foldable. The sampler may become folded when the handle, the upper cup panel, the bottom cup panel and the bridge panel fold at the first, second, third and fourth edges may all lie in a single plane, when not in use, when packaged for shipping, or when in storage to reduce space.

[0037] Another useful feature of all of the embodiments of a disposable hand held urine sampler according to present invention relates to the angle of the handle 102, 202 relative to the parallelogram structure 140, 240. According to the particular embodiment of a sampler 100 shown in FIG. 1 , the handle 102 extends at an angle, Q, relative to any perpendicular line extending from a plane through which either the upper cup holder panel 1 14 or the bottom cup holder panel 108 extends when the specimen cup 500 is placed through the second 126 and first 124 circular openings during use.

[0038] FIG. 7A is a plan view of an embodiment of a pattern 704 for a disposable hand-held urine sampler 700, according to the present invention. The embodiment of a pattern 704 for sampler 700 is configured to be cut from lightweight milled paper or cardboard as shown in FIG. 7B. FIG. 7B illustrates pattern 704, shown in FIG. 7A, after it has been cut from lightweight milled paper or cardboard. [0039] As further shown in FIG. 7A, an embodiment of pattern 704 for a disposable urine sampler 700 may further include a handle floor panel 710 in which four slots 724 are cut. The embodiment of a pattern 704 for a disposable urine sampler 700 may further include opposed side panels 712, a bridge panel 708 located between first and second cup holder panels 714A and 714B and handle ceiling panel 716 adjacent to second cup holder panel 714B. The embodiment of a handle ceiling panel 716 may further include four tabs 720 each corresponding to a respective slot 724. Embodiments of opposed side panels 712 may each have notches 722 located near the first cup holder panel 714A. The notches 722 define finger tabs 726 adjacent to first cup holder panel 714A.

Second cup holder panel 714B may also be configured with cutouts 742 adjacent to handle ceiling panel 716 and fold line 734. According to the embodiment of pattern 704 illustrated in FIGS. 7A and 7B, a hole 728 may be formed in the proximate end 730 of handle floor panel 710.

[0040] Pattern 704 is configured to be assembled by folding and tucking tabs

720 into corresponding slots 724. More particularly, opposed side panels 712 are configured to be folded in toward handle floor panel 710 at fold lines 732 located between opposed side panels 712 and the handle floor panel, thus opening slots 724. Handle ceiling panel 716 is configured to be folded toward handle floor panel 710 at fold line 734 located between the handle floor panel 710 and second cup holder panel 714B. Second cup holder panel 714B may be configured to fold toward handle floor panel 710 at fold lines 736 and 738. Finally, first cup holder panel may be configured to fold toward handle floor panel 710 and fold line 740.

[0041] FIG. 7C illustrates a perspective image of the embodiment of a disposable hand-held urine sampler 700 shown in FIGS. 7A and 7B, folded with a urine sample cup 750 placed through first and second circular openings 706A and 706B, according to the present invention. As shown in FIG. 7C, handle ceiling panel 716 overlays handle floor panel 710 with slots 724 aligned with tabs 720. As further shown in FIG. 7C, first and second cup holder panels 714A-B are generally parallel to each other and separated by bridge panel 708. Additionally, first and second circular openings 706A-B are aligned by urine sample cup 750. This configuration of disposable hand-held urine sampler 700 provides stable support to urine sample cup 750 [0042] FIG. 7D illustrates another perspective image of the embodiment of the disposable hand-held urine sampler 700 shown in FIGS. 7A-7C, completely folded and ready to use with urine sample cup cap 752 removed. Finger tabs 726 may be folded in toward cup 750 as facilitated by notches 722, thereby holding first and second cup holder panels 714A-B generally parallel to each other in tandem with bridge panel 708.

[0043] Handle 702 may be gripped as shown in FIG. 7D during use. In practice, the embodiment of a disposable hand-held urine sampler 700 is held by handle 702 to capture urine from the user/patient within urine sample cup 750. After sufficient urine is filled within urine sample cup 750, cap 752 may be placed on cup 750 to seal and the sample 700 discarded. Because of the elongated handle 702 there is less risk of the patient urinating on their own hands/fingers.

[0044] FIGS. 8A and 8B are plan and perspective views of another embodiment of a disposable hand-held-urine sampler, according to the present invention. More particularly, FIG. 8A illustrates pattern or frame 804 used to form disposable hand held urine sampler 800. The terms "pattern" and "frame" are used interchangeably herein. However, it will be understood that as described herein, a pattern place on or cut from lightweight paper or cardboard stock is used to form the frame. The frame may be folded along fold lines that are identified in the pattern according to various embodiments herein. FIG. 8B illustrates a perspective view of the embodiment of a pattern 804 for sampler 800 after it has been cut from lightweight milled paper or cardboard, folded and then glued together to form a handle 802 and sample cup receptacle 848 formed coaxially aligned first and second circular openings 806A-B. FIG. 8B illustrates sampler 800 after it has been cut from lightweight milled paper or cardboard. This embodiment of sampler 800 is similar to sampler 700, except simpler in that the opposed side panels 712, and other features, have been removed in their entirety.

[0045] As further shown in FIG. 8A, an embodiment of pattern, shown generally at arrow 804 for a disposable urine sampler 800 may further include a handle floor panel 810 with proximate end 830. The embodiment of a pattern 804 for a disposable urine sampler 800 may further include a bridge panel 808 located between first and second cup holder panels 814A and 814B and handle ceiling panel 816 adjacent to second cup holder panel 814B. The embodiment of a handle ceiling panel 816, having a distal end 844, may further include four tabs 820 each corresponding to four respective tabs 820 located on handle floor panel 810. According to the embodiment of pattern 804 illustrated in FIGS. 8A and 8B, a holes 828 may be formed near the proximate end 830 of handle floor panel 810 and the distal end 844 of handle ceiling panel 816.

[0046] Disposable urine sampler 800 may be assembled from pattern 804 by:

(1 ) folding handle ceiling panel 816 toward second cup holder panel 814B at first fold line 834, (2) folding second cup holder panel 814B toward bridge panel 808 at second fold line 836, (3) folding the bridge panel 808 toward the first cup holder panel 814A at third fold line 838, folding first cup holder panel 814A toward handle floor panel 810 at fourth fold line 840, and (5) applying an adhesive between handle floor panel 810 and handle ceiling panel 816 such that when pressed together a handle 802 is formed, see FIG. 8B.

[0047] According to the illustrated embodiment of sampler 800, handle has proximate 830 and distal 844 ends of handle floor and ceiling panels 810 and 816, respectively, adjacent to one another and the four tabs 820 of handle floor panel 810 aligned with the four tabs 820 of handle ceiling panel 816. It will be

understood that other handle configurations or embodiments are also possible, for example and not by way of limitation, a handle that has no tabs at all (not shown), a handle that does not taper (not shown) from urine sample cup receptacle 848 to the aligned proximate 830 and distal 844 ends. According to the illustrated embodiment, handle 802 shown in FIG. 8B tapers from urine sample cup receptacle 848 to the aligned proximate 830 and distal 844 ends.

[0048] As shown in FIG. 8B, a urine sample cup 850, with (as shown) or without urine sample cup cap 852 may be placed in a sample cup receptacle 848 formed by the first and second circular openings 806A and 806B that are aligned with centers passing through an axis (not shown) of the cup 850. The assembled disposable hand-held urine sampler 800 shown in FIG. 8B, shows first and second cup holder panels 814A-B to be parallel to each other and separated by bridge panel 808 and a corresponding portion 846 of handle floor panel 810. The corresponding portion 846 may be located between fold line 840 and two tabs 820 located on handle floor panel 810, according to the illustrated embodiment.

[0049] FIG. 8C is a top view of the disposable hand-held-urine sampler 800shown in FIGS. 8A and 8B, folded flat, according to the present invention. Pre glued versions of disposable hand-held urine sampler 800 may be folded at second fold line 836 with handle floor 810 and ceiling 816 panels adhered together (using glue, staples or any other means for adhering the two panels 810 and 816 together). Pre-glued versions of disposable hand-held urine sampler 800 folded as shown in FIG. 8C may be stacked and stored in bulk or otherwise packaged for shipping and storage.

[0050] In order to use folded sampler 800, the other three fold lines, 834, 838 and 840 are engaged to separate the first and second cup holder panels 814A-B from one another in a parallel configuration thus aligning first and second circular openings 806A-B to form a receptacle 848 for receiving urine sample cup 850, see FIG. 8B. During use a cup 850 without cap 852 is placed within receptacle 848, the user grasps the handle 802, places the cup 850 adjacent to the user's urethra (not shown) and delivers the desired measure of urine into the cup without concern for urinating on the user's hands because of the extended handle 802. The cup 850 can then be capped 852 and delivered to the lab for analysis as needed.

[0051] Structural features of the embodiments of urine samplers 100, 200, 700 and 800 may be formed of any suitable material, for example and not by way of limitation, lightweight milled paper or cardboard for low cost and eco-friendly waste decomposition. Note that the embodiments of urine samplers 100, 200, 700 and 800 disclosed herein may have any suitable dimensions. The particular dimensions illustrated in the drawings are merely exemplary and not intended to limit the scope of the present invention. Having described particular embodiments of the urine samplers 100, 200, 700 and 800 disclosed above, generic

embodiments will now be described.

[0052] An embodiment of a disposable hand-held urine sampler is disclosed. The embodiment of a disposable hand-held urine sampler may include a frame cut along a pattern from lightweight milled paper or cardboard and folded to form an assembled frame for supporting a urine sample cup. According to one embodiment, the frame may further include a handle floor panel having a proximate end. The embodiment of a frame may further include a first cup holder panel extending from handle floor panel along a first fold line and including a first circular opening. The embodiment of a frame may further include a bridge panel extending from the first cup holder panel along a second fold line. The

embodiment of a frame may further include a second cup holder panel extending from the bridge panel along a third fold line and including a second circular opening. The embodiment of a frame may further include a handle ceiling panel having a distal end. According to this embodiment, the handle ceiling panel may extend from the second cup holder panel along a fourth fold line.

[0053] According to another embodiment, the disposable hand-held urine sampler may further include opposed side panels extending from the handle floor panel along respective opposing fold lines. According to yet another embodiment of the disposable hand-held urine sampler, the handle floor panel may be adhered to the handle ceiling panel with the proximate and distal ends adjacent one another by folding along the second fold line only, thereby forming a handle. According to still another embodiment of the disposable hand-held urine sampler, the first cup holder panel may be separated and parallel to the second cup holder panel by further folding along the first, third and fourth fold lines. According to still yet another embodiment of the disposable hand-held urine sampler, a urine sample cup may be placed through the first and second circular openings.

According to a particular embodiment the disposable hand-held urine sampler may be formed of lightweight milled paper or cardboard.

[0054] While the foregoing advantages of the present invention are manifested in the illustrated embodiments of the invention, a variety of changes can be made to the configuration, design and construction of the invention to achieve those advantages. For example, the tabs 820 shown on the handle 802 of sampler 800 (see FIGS. 8A-8C) may be removed in their entirety according to an alternative embodiment, with essentially the same functionality. Hence, reference herein to specific details of the structure and function of the present invention is by way of example only and not by way of limitation.