WO 2020/081784
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`PCT/US2019/056693
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`MIDSTREAM URINE COLLECTION
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`CROSS-REFERENCE TO RELATED APPLICATIONS
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`[0001] This application claims priority to U.S. provisional application No. 62/746,948
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`filed on October 17, 2019 incorporated herein by referencein its entirety.
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`FIELD OF THE INVENTION
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`[0002] The present disclosure generally relates to midstream urine collection and, in
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`particular, a device for midstream urine collection which usesa rotatable diverter having
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`an actuation panel with a piece of absorbent material affixed thereto.
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`BACKGROUND OF INVENTION
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`[0003] To diagnose a urinary tract infection (UTI) and determine which antibiotic
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`should be usedfor treatment, a patient’s urine is streaked on an agar plate and
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`sensitivity analysis is performed. In order to collect a “clean” sample that is
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`representative of what is in the bladder and not on the external skin, the patient must
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`urinate about 10-25 mL into the toilet and then catch some urine in a small plastic cup.
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`There are multiple error-prone steps in this process, and it is difficult to perform for
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`many patients, especially women and those with dexterity deficits. A 2007 study showed
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`that UTIs accounted for 13.5 million office visits and a total cost of $13.5 billion
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`(including the time lost from work). Before the age of 60, women are more 30 times
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`morelikely to experience a UTI than men (as patients age, the incidence of UTIs among
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`men and women becomes comparable). Consequently, women constitute 97% of the
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`UTI population.
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`[0004] A midstream, clean catch sample is considered ideal for culture and sensitivity
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`testing of the urine. In practice, however, patients often are not providing adequate
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`clean catch samples. The ideal process entails many detailed steps and, in many
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`cases, the patient is either not counseled or is given confusing instructions for providing
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`an “ideal’ sample. Moreover, the instructions given can vary widely among providers.
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`For women, the process is moredifficult than for men. Women maygeturine on their
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`hand, for example, or may not be able to direct their urine stream. For these reasons
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`and others, most patients do not adequately collect a clean catch sample.
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`Contamination is a very common problem in such samples, and it delays evidence-
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`based decision making. At a typical institution, there may be a contamination rate of 35-
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`45% for urine samples. Without a sensitivity analysis from culture, the best antibiotic
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`cannot be prescribed, and instead the provideris left with three bad options: (1) do
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`nothing, (2) prescribe an empiric antibiotic which might not provide the best coverage,
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`(3) redo the test, which takes a minimum of 48 hours to perform. Doing nothing risks
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`leaving a potential underlying infection to grow. Prescribing antibiotics without sensitivity
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`information is not ideal either, as antibiotic stewardship is important in a world with ever-
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`increasing antibiotic resistance. Redoing the test is time-consuming, which delays
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`patient treatment and clinical decision-making in addition to adding cost to the hospital.
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`SUMMARYOF INVENTION
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`[0005] Disclosed embodiments provide a device which simplifies the clean-catch urine
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`collection process and decreases rates of contamination during microbial culture.
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`Disclosed embodiments provide a gravity fed system that compartmentalizes dirty and
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`clean catch urine samples. The dirty sample, whichis filled with epithelial and skin cells,
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`is not only separated from the clean but discarded along with the remaining excess
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`urine not neededfor either urinalysis or urine culture.
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`[0006] Disclosed embodiments provide a container that includes a rotating internal
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`partition that diverts the flow of fluid during collection. The first 10-25 mL of “dirty” urine
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`falls into an initial compartment and causesthe internal partition to flip. This
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`rearrangementredirects the next portion of fluid into the second “clean” compartment. A
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`needle is recessed into the container for use with vacuum collection tubes which allows
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`for easy transfer of urine into separate vials. The device has the potential to include an
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`ergonomic funnel whichfits comfortably with the patient’s anatomy and directs the flow
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`of urine. The device also has the potential to include an outflow modality in the outer
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`container shell.
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`[0007] The device described in the disclosed embodiments makesthe process of
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`providing a urine sample easier for the patient. Instead of multiple confusing steps to
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`follow, the patient simply needs to urinate into the device. The automatic separation of
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`“dirty” from “clean” portions decreases the rate of contamination. The current “gold
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`standard”is a simple screw-cap plastic cup that has not been improved in decades. The
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`new design greatly improves on the old methodof collecting urine for culture testing.
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`[0008] The disclosed embodiments provide a device which improvesclinical decision
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`making, decreasesurine collection costs, and aligns with the goals of antibiotic
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`stewardship programs. The improved outcomesas a result of decreased contamination
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`and better patient experience are expected to outweigh increased cost and size.
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`Furthermore, the overall cost of the urine collection process will be decreased with this
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`device due to a decrease in contamination rates.
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`[0009]
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`In one aspect, the disclosed embodiments provide a midstream urine collection
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`device and associated method. The device has a housing comprising an outer wall
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`enclosing an interior volume, the interior volume having an upper portion which forms
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`an initial collection well, and a lower portion which is divided by a dividing wall into an
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`initial stream collection reservoir and a midstream collection reservoir. A collection
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`cavity is formed on top of the housing by an upwardly-extending portion of the outer
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`wall, the collection cavity having a collection drain in a bottom thereof to allow a urine
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`stream to flow into the housing. The housing has a rotatable diverter having a deflection
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`panel and an actuation panel joined along a fulcrum axis. The diverter is adapted to
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`rotate between a first position in which the actuation panel is positioned to separate the
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`initial collection well from the initial stream collection reservoir and the deflection panel
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`is positioned to separate theinitial collection well from the midstream collection
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`reservoir; and a second position in which the deflector panel deflects the urine stream
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`received through the collection drain into the midstream collection reservoir. The
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`actuation panel has a piece of absorbent material affixed to a top surface thereof, within
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`the initial collection well.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`[0010]
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`In the drawings, identical reference numbers identify similar elements or acts.
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`The sizes and relative positions of elements in the drawings are not necessarily drawn
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`to scale. For example, the shapes of various elements and angles are not necessarily
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`drawn to scale, and some of these elements may be arbitrarily enlarged and positioned
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`to improve drawing legibility. Further, the particular shapes of the elements as drawn,
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`are not necessarily intended to convey any information regarding the actual shape of
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`the particular elements, and may have been solely selected for ease of recognition in
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`the drawings.
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`[0011]
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`Fig. 1 is a top perspective view of a first embodiment of a midstream urine
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`collection device.
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`[0012]
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`Fig. 2 is a bottom perspective view of the first embodiment of the midstream
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`urine collection device.
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`[0013] Figs. 3 and 4 are side, hidden line viewsofthe first embodiment of the
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`midstream urine collection device.
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`[0014]
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`Fig. 5 is a side cross-sectional view of the first embodiment of the midstream
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`urine collection device, the view depicting a first stage of a urine collection process.
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`[0015]
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`Fig. 6 is a side cross-sectional view of the first embodiment of the midstream
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`urine collection device, the view depicting a second stage of a urine collection process.
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`[0016]
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`Fig. 7 is a side cross-sectional view of the first embodiment of the midstream
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`urine collection device, the view depicting a third stage of a urine collection process.
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`[0017]
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`Fig. 8 is aside, hidden line view of a second embodiment of a midstream urine
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`collection device.
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`[0018]
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`Fig. 9 is a side, hidden line view of the second embodiment of the midstream
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`urine collection device, the view depicting a first stage of a urine collection process.
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`[0019]
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`Fig. 10 is a side, hidden line view of the second embodiment of the midstream
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`urine collection device, the view depicting a second stage of a urine collection process.
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`[0020]
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`Fig. 11 is a side, hidden line view of the second embodiment of the midstream
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`urine collection device, the view depicting a third stage of a urine collection process.
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`[0021]
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`Fig. 12 is an exploded perspective view of a third embodiment of the midstream
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`urine collection device.
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`[0022]
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`Fig. 13A is a perspective view of the third embodiment of the midstream urine
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`collection device.
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`[0023]
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`Fig. 13B is a partial perspective view of the third embodiment of the midstream
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`urine collection device.
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`[0024]
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`Fig. 14A is a side, hidden line view of the third embodiment of the midstream
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`urine collection device showing the carousel compartment in a first position.
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`[0025]
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`Fig. 14B is a side, hidden line view of the third embodiment of the midstream
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`urine collection device showing the carousel compartment in a second position.
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`DETAILED DESCRIPTION OF THE EMBODIMENTS
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`[0026]
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`In the following description, certain specific details are set forth in order to
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`provide a thorough understanding of various disclosed implementations. However, one
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`skilled in the relevant art will recognize that implementations may be practiced without
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`one or moreof these specific details, or with other methods, components, materials, etc.
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`[0027] The disclosed embodiments relate to devices for clean catch urine collection for
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`microbial culture. The devices are not meantto replace all other urine cups, as notall
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`urine tests require a “clean” sample. Therefore, the disclosed devices mayfill a niche for
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`urine culture and sensitivity testing. The devices are sterile and disposable. In practice,
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`one device is used per urine collection. The portion of the device that contains the
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`needle may be separately disposed of as a sharp, while the rest of the plastic can
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`potentially be recycled or disposedof in the regular waste, as urine is not considered a
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`biohazard.
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`[0028] Figs.
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`1 and 2 show a top and bottom perspective view, respectively, of a first
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`embodiment of a midstream urine collection device 100. The collection device 100 has
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`a housing 110 formed of plastic, e.g., injection molded polypropylene, with a generally
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`roundedor oval shapeto allowit to be easily gripped. The collection device 100 has a
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`flat bottom 120 to allow it to stand on a flat surface. An output, i.e., an excess spout
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`170, is formedin the bottom 120 of the housing 110 to allow excessurine to be
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`dispelled.
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`[0029]
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`In an upper portion of the collection device 100, an outer wall 130 of the
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`housing 110 extends upward to form an open cavity, i.e., a collection cavity 140,
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`surroundedby a funnel wall 150. An extended lip 155 is formed in a front portion of the
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`funnel wall 150. The extendedlip 155 extends higher than a remaining portion of the
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`funnel wall 150 and curves outward in a forward direction. The lip 155 of the funnel wall
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`150 serves to direct the urine stream into the collection cavity 140.
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`[0030] An extraction port 160 is formed at a rear portion of the funnel wall 150. In the
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`illustrated implementation, the extraction port 160 extends from a top edgeof the funnel
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`wall 150, or just below the top edge, into the interior volume of the housing 110. As
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`discussed in further detail below, the extraction port 160 allows accessto urine stored in
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`the housing 110 so that it can be collected. The extraction port 160 has a cannula 161
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`extending therefrom for insertion into a vacuum collection tube (not shown). In such a
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`case, the vacuum collection tube (not shown) is pressed down on to the extraction port
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`160, which results in the cannula 161 entering a sealed opening in the lid of the vacuum
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`collection tube. This connection allows negative pressure in the vacuum collection tube
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`to extract the urine via an extraction tube 162 (see Figs. 3-7). The extraction tube 162 is
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`connected to a back side of the extraction port 160 and extends downinto the
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`midstream collection reservoir 420 (see Fig. 4 and corresponding description below).
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`[0031] Figs. 3 and 4 are side, hidden line viewsofthe first embodiment of the
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`midstream urine collection device 100. Fig. 3 shows an implementation having a
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`shorter, more gently sloped lip 155 and includes an enlarged view of the hinge, which is
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`discussed below. Fig. 4 shows an implementation having a longer, peaked lip 155 and a
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`simplified representation of the hinge for ease of description.
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`[0032] Referring to Fig. 4, the outer wall 130 of the housing 110 extends upward to
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`form the collection cavity 140, which is surrounded by the funnel wall 150. The lip 155 of
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`the funnel wall 150 servesto direct the urine stream into the collection cavity 140. A
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`collection drain 405 is formed in the bottom of the collection cavity 140 to allow urine to
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`flow into the interior volume defined by the housing 110. The interior volume has a lower
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`portion which is divided into an initial stream collection reservoir 415 and a midstream
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`collection reservoir 420 by an inwardly-extending portion of the housing 110 which
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`forms a dividing wall 425 between the two reservoirs. In implementations, the dividing
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`wall 425 may be formedbya barrier formedin, or installed in, the interior volume (see
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`Fig. 3).
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`[0033] The interior volume has an upper portion which forms an initial collection well
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`430. In a first stage of a urine collection process, which is discussed in further detail
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`below, the initial collection well 430 is isolated from the midstream collection reservoir
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`420 by a rotatable diverter 440 having a deflection panel 445 and an actuation panel
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`450, which are joined along one side at a fulcrum axis 455 at or near an axis of rotation
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`of the diverter 440. The fulcrum axis 455 is positioned at or near a top edge of the
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`dividing wall 425 and runs parallel to the dividing wall 425, extending from one side of
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`the housing 110 to the other. The actuation panel 450is fixed in a generally horizontal
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`orientation defining a bottom of the initial collection well 430. The actuation panel 450 is
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`maintained in this position by a piece of adhesive paper 460 whichis affixed to the
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`actuation panel 450 and to an inner surface of the housing 110. A piece of absorbent
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`material, €¢.g., a sponge 465, is affixed to a top surface of the actuation panel 450 so
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`that it is positioned at the bottom of the initial collection well 430. The deflection panel
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`445 may form an obtuse angle with the actuation panel 450. This arrangementholds the
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`deflection panel 445 in a position such that it blocks the flow of urine into the midstream
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`collection reservoir 420.
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`[0034] As explained below, in the description associated with Figs. 5-7, the diverter
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`440 rotates during the urine collection processto direct the initial portion of the stream
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`into the initial stream collection reservoir 415 and the remainderof the stream into the
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`midstream collection reservoir 420.
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`[0035]
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`Fig. 5is a side cross-sectional view of the first embodiment of the midstream
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`urine collection device. The view depicts a first stage of a urine collection process, i.¢., a
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`stage in which the collection of the urine stream 510 has been initiated. The urine
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`stream 510 is captured in the collection cavity 140 and enters the initial collection well
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`430 via the collection drain 405 is formed in the bottom of the collection cavity 140. The
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`stream 510 is at least partially directed to the sponge 465, although a portion of the
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`urine flows over the actuation panel 450. The adhesive paper 460 and the sponge 465
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`absorb urine as it enters the initial collection well 430, which causes the adhesive paper
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`460 to deteriorate and causes the sponge 465to increasein weight.
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`[0036]
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`Fig. 6 is a side cross-sectional view of the first embodiment of the midstream
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`urine collection device. The view depicts a second stage of a urine collection process,
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`i.e., a stage in which midstream urine is collected. The adhesive paper 460 deteriorates
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`as the urine flow continues and the sponge 465 continuesto increase in weight until its
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`absorbent capacity has been reached. At some pointafter initiation of the urine stream,
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`the adhesive paper 460 breaks, thereby allowing rotation of the diverter 440 (i.e.,
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`rotation in the counter clockwise direction in the illustrated implementation). The paper
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`460 breaks when its tensile strength is overcome due to a combination of dissolution of
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`the paper 460 by the urine and the increasing tensile force applied by the actuation
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`panel 450 as the weight of the sponge 465 increases due to absorption of the urine. The
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`rotation of the diverter 440 results in the actuation panel 450 extending generally
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`downward, about 90 degreesfrom its original position in this example. This, in turn,
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`causes any remaining urine in the initial collection well 430 to drain into the initial stream
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`collection reservoir 415. The urine collected in the initial stream collection reservoir 415
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`drains from the excess spout 170 at the bottom of the housing 110 until the reservoir
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`415 is empty.
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`[0037] The rotation of the diverter 440 causes the deflector panel 445 to moveinto a
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`position such that it deflects the urine stream 510 received through the collection drain
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`405 into the midstream collection reservoir 420. In this position, the deflector panel 445
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`may be at an acute angle with respect to horizontal, such that it slopes downward
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`toward the fulcrum axis 455 and the midstream collection reservoir 420. By virtue of this
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`configuration, the initial stream urine is discarded via the excess spout 170, and the
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`midstream urine is collected in the midstream collection reservoir 420.
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`[0038]
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`Fig. 7 is a side cross-sectional view of the first embodiment of the midstream
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`urine collection device. The view depicts a third stage of a urine collection process, i.e.,
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`a stage in which the urine is retrieved from the midstream collection reservoir 420 using
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`a vacuum collection tube arrangement. The extraction port 160 has a cannula 161
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`extending therefrom for insertion into a vacuum collection tube 710. In such a case, the
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`vacuum collection tube 710 is pressed down on to the extraction port 160, which results
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`in the cannula 161 entering a sealed opening in the lid 720 of the vacuum collection
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`tube 710. This connection allows negative pressure in the vacuum collection tube 710 to
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`extract the urine via an extraction tube 162. The extraction tube 162 is connected to a
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`back side of the extraction port 160 and extends downinto the midstream collection
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`reservoir 420
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`[0039]
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`Fig. 8 is a side, hidden line view of a second embodiment of a midstream urine
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`collection device 800. The device 800 has a housing 805 enclosing an interior volume.
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`The housing 805 may have various shapes, such as, for example, round, square with
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`rounded corners and sides, and rectangular with rounded corners and sides. The
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`housing 805 is open at the top to receive a urine stream. A collection tube 822 extends
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`downward from a collection tube output 833 which extends through the housing 805.
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`[0040] The interior volume has an upperportion which forms an initial collection well
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`830. In a first stage of a urine collection process, which is discussed in further detail
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`below, the initial collection well 830 is separated from the initial stream collection
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`reservoir 815 by a rotatable diverter 840 having a deflection panel 845 and an actuation
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`panel 850, which are joined along one side at a fulcrum axis 855 at or near an axis of
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`rotation of the diverter 840. The fulcrum axis 855 (which in this example is coincident
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`with an axis of rotation of the diverter 840) is positioned at or near an inner sidewall of
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`the housing 805, in an approximate midsection of the housing 805, and extends from
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`one side of the housing 805 to the other.
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`[0041] The actuation panel 850is fixed in a generally horizontal orientation defining a
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`bottom ofthe initial collection well 830. The actuation panel 850 is maintained in this
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`position by a piece of adhesive paper 860 whichis affixed to the actuation panel 850
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`and to an inner surface of the housing 805, e.g., a protrusion 807 extending from the
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`inner surface. A piece of absorbent material, e.g., a sponge 865, is affixed to a top
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`surface of the actuation panel 850 sothatit is positioned at the bottom of the initial
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`collection well 830. The deflection panel 845 forms a generally perpendicular angle with
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`the actuation panel 850. This arrangement holds the deflection panel 845 in a position
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`suchthatit blocks the flow of urine into the collection tube output 833 and the collection
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`tube 822. In the depicted implementation, the collection tube output 833 is positioned at
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`or near the bottom of the initial collection well 830, i.e., the bottom formed by the
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`actuation panel 850.
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`[0042] As explained below, in the description associated with Figs. 9-11, the diverter
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`840 rotates during the urine collection processto direct the initial portion of the urine
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`stream into the initial stream collection reservoir 815 and the remainder of the stream
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`into the collection tube output 833.
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`[0043]
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`Fig. 9 is a side, hidden line view of the second embodimentof the midstream
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`urine collection device 800. The view depicts a first stage of a urine collection process,
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`i.€., a stage in which the collection of the urine stream 510 has been initiated. The urine
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`stream 510 enters the initial collection well 830 via the opening 802 at the top of the
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`housing 805. The stream 510 is at least partially directed to the sponge 865, although a
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`portion of the urine flows over and around the actuation panel 850. The adhesive paper
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`860 and the sponge 865 absorburine asit enters theinitial collection well 830, which
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`causes the adhesive paper 860 to deteriorate and causes the sponge 865to increasein
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`weight.
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`[0044]
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`Fig. 10 is a side, hidden line view of the second embodiment of the midstream
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`urine collection device 800. The view depicts a second stage of a urine collection
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`process, i.e., a stage in which midstream urine is collected. The adhesive paper 860
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`deteriorates as the urine flow continues and the sponge 865 continuesto increase in
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`weight until its absorbent capacity has been reached. The adhesive paper 860
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`eventually breaks, thereby allowing rotation of the diverter 840 (i.e., rotation in the
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`counter clockwise direction in the illustrated implementation) under the weight of the
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`sponge 865. Therotation of the diverter 840 results in the actuation panel 850
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`extending generally downward. This, in turn, causes any remaining urine in the initial
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`collection well 830 to drain into the initial stream collection reservoir 815. The urine
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`collected in the initial stream collection reservoir 815 drains from the excess spout 870
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`at the bottom of the housing 805 until the reservoir 815 is empty.
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`[0045] The rotation of the diverter 840 causes the deflector panel 845 to moveinto a
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`position such that it deflects the urine stream to the collection tube output 833 and the
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`collection tube 822. In this position, the deflector panel 845 initially may be at an acute
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`angle with respect to horizontal, such that it slopes downward toward the collection tube
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`output 833.
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`[0046]
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`Fig. 11 is a side, hidden line view of the second embodiment of the midstream
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`urine collection device. The view depicts a third stage of a urine collection process, i.e.,
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`a stage in which the deflector panel 845 settles into a horizontal orientation such thatit
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`separates the initial collection well 830 from the initial stream collection reservoir 815. At
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`this point, the initial collection well 830 serves, in effect, as a midstream collection
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`reservoir. By virtue of this configuration, the initial stream urine is discarded via the
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`excess spout 870, and the midstream urine is collected in the collection tube 822. The
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`collection tube output 833 may include an extraction port (not shown) and an extraction
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`tube (not shown) which extends into the collection tube 822 to allow extraction of the
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`urine via a vacuum collection tube. Alternatively, the collection tube output 833 may
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`include an extraction port (not shown) which allows a vacuum collection tube to be
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`directly connected to extract urine from the initial collection well/midstream collection
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`reservoir 830.
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`[0047]
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`Fig. 12 is an exploded perspective view of a third embodiment of the midstream
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`urine collection device 1200. The device 1200 has a housing 1205 formed bya left side
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`housing 1210 and a right side housing 1215. The side housings (1210 and 1215) each
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`have a side outer face (1220 and 1222) generally in the shape of a quarter of a circle,
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`with an arcuate portion being the front facing edge. Walls (1224 and 1226) extend from
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`the side outer faces (1220 and 1222) to form an interior volume of the housing 1205.
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`[0048] The side housings (1210 and 1215) each have arcuate protrusions and/or
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`grooves (1230 and 1232) which are generally parallel to arcuate portions of the walls
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`(1224 and 1226). The arcuate protrusions and/or grooves 1230 serve as guide tracks
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`for positioning and rotation of a carousel 1235 installed within the housing 1205 (the
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`protrusions and/or groovesin the left side housing are not visible in Fig. 12). The
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`carousel 1235 has corresponding arcuate protrusions and/or grooves 1237 which mate
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`with the protrusions and/or grooves 1230 of the side housings (1210 and 1215) to allow
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`the carousel 1235 to rotate within the side housings (1210 and 1215). The carousel
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`1235 has two compartments for receiving the urine stream: an initial stream collection
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`compartment 1245, in an lower position, and a midstream collection compartment 1250,
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`in a upper position. The initial stream collection compartment 1245 may be covered with
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`a piece of one ply paper (not shown) which dissolves shortly after the initiation of the
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`urine stream. The initial stream collection compartment 1245 may include an opening
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`1247 on a wall thereof to allow excess urine to be dispelled.
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`[0049] The side housings (1210 and 1215) have generally rectangular receptacles
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`(1211 and 1216) at a top portion thereof which are configured to receive a footing 1239
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`of a handle 1240 to attach the handle to the top of the housing 1205. The walls (1224
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`and 1226) have gaps in an arcuate portion thereof adapted to receive a lid 1255 which
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`creates a seal with the initial stream collection compartment 1245 and the midstream
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`collection compartment 1250, depending upon the position of the carousel 1235. The lid
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`may be formed, for example, of a plastic elastomer, and may have an opening 1257
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`adapted to receive a vacuum collection tube.
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`[0050]
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`Ina first stage of the urine collection process, the carousel 1235 is positioned
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`so thatthe initial stream collection compartment 1245 is aligned with the lid 1255. Ina
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`second stage of the urine collection process, after initiation of the urine stream, the
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`weight of the urine in the initial stream collection compartment 1245 causes the
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`carousel 1235 to rotate so that the midstream collection compartment 1250 is aligned
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`with the lid 1255. This allows the midstream collection compartment 1250 to collect the
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`midstream urine sample.
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`12
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`

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`WO 2020/081784
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`PCT/US2019/056693
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`[0051] Figs. 13A and 13B are perspective viewsof the third embodimentof the
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`midstream urine collection device 1200. The view of Fig. 13 shows the midstream urine
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`collection device 1200 in its assembled form. The patient holds the device by the handle
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`1240 while directing the urine stream to the opening in the lid 1255.
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`[0052] Figs. 14A and 14B showa side, hidden line view of the midstream urine
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`collection device 1200. In FIG. 14A, the carousel is in a first position, i.e., a position in
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`which the initial stream collection compartment 1245 is aligned with the lid 1255 in the
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`first stage of the urine collection process. In FIG. 14B, the carousel is in a second
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`position, i.e., a position in which the midstream collection compartment 1250 is aligned
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`with the lid 1255.
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`[0053] The various implementations described above can be changed and/or
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`combined to provide further implementations in light of the above-detailed description.
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`In general, in the following claims, the terms used should not be construedto limit the
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`claims to the specific implementations disclosed in the specification and the claims, but
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`should be construedto include all possible implementations along with the full scope of
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`equivalents to which such claims are entitled. Accordingly, the claims are not limited by
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`the disclosure.
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`13
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