ERS
`
`SSE ANS
`
`RS
`
`SUS FS
`
`United States Patent aad Trademark Office
`
`October 31, 2019
`
`
`
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`UNTTED STATES DEPARTMENT OF COMMERCE
`
`
`
`
`
`
`
`
`
`
`
`
`“3
`e
`
`pe AB ERANLome
`
`
`
`Under Seerctary of Commerce
`for Intellectual Praperty
`
`
`and Director of Ure United States
`
`Patent and Yrademark Office
`
`THIS IS TO CERTIFY THAT ANNEXED HERETO IS A TRUE COPY FROM
`THE RECORDSOF THE UNITED STATES PATENT AND TRADEMARK
`OFFICE OF THOSE PAPERS OF THE BELOW IDENTIFIED PATENT
`APPLICATION THAT MET THE REQUIREMENTSTO BE GRANTED A
`FILING DATE.
`
`APPLICATION NUMBER: 62/746,948
`FILING DATE: October 17, 2018
`RELATED PCT APPLICATION NUMBER: PCT/US19/56693
`
`
`
`THE COUNTRY CODE AND NUMBER OF YOUR PRIORITY
`APPLICATION, TO BE USED FOR FILING ABROAD UNDER THE PARIS
`CONVENTION,IS US62/746,948
`
`Certified by
`
`

`

`PROVISIONAL APPLICATION COVER SHEET
`
`This is a requestforfiling a PROVISIONAL APPLICATION under 37 CFR 1.53(c).
`
`Docket #: 6107-233P/440710|eeearssenrimses
`
`
`INVENTOR(S)/APPLICANT(S)
`
`
`NAME (First, Middle, Last)
`
`RESIDENCE(City and either State or Country)
`
`Dante VAROTSIS
`
`Anthony DIFRANCO
`
`Christopher NEELY
`
`Helen XU
`
`Philadelphia, PA,
`
`Philadelphia, PA,
`
`Macungie, PA
`
`Philadelphia, PA
`
`credit any overpayment to Deposit Acct. No. 503111.
`
`ENCLOSED APPLICATION PARTS(checkail that apply)
`Numberof Pages[18]
`[] Other (specify)
`
`TITLE OF THE INVENTION (280 characters max)
`
`Midstream Urine Collection
`
`CORRESPONDENCE ADDRESS
`
`
`Carl B. Wischhusen, Esq.
`(212) 883-4900
`
`Cozen O'Connor
`277 Park Avenue
`New York, NY 10172
`
`Customer Number:
`27799
`
`[x]
`
`Specification
`
`Drawing(s)
`
`Numberof Pages[14]
`
`METHOD OF PAYMENT (check one)
`
`[x]
`
`The Commissioneris hereby authorized to chargethefiling fees or
`
`PROVISIONAL FILING FEE
`AMOUNTS:
`$140
`[] Each Add 50 Sheetsin
`
`LEGAL\38776152\1
`
`

`

`The invention was made by an agency of the United States Government or under a contract with an agency
`of the United States Government
`
`[x]
`
`[
`
`]
`
`[x]
`
`No
`
`Yes, the name of the U.S. Government agency and the Governmentcontract numberare:
`
`Small Entity Status is claimed
`
`Respectfully submitted,
`COZEN O’CONNOR
`
`By:
`
`‘Carl B. Wischhusen/
`Carl B. Wischhusen
`Reg. No. 43,279
`2/7 Park Avenue
`New York, New York 10172
`(212) 883-4900
`
`Dated: October 17, 2018
`
`PROVISIONAL APPLICATION FILING ONLY
`
`LEGAL\38776152\1
`
`

`

`PTO/SB/14 (08-12)
`Approvedfor use through 01/31/2014. OMB 0651-0032
`U.S. Patent and Trademark Office; U.S. DEPARTMENT OF COMMERCE
`Under the Paperwork Reduction Act of 1995, no persons are required to respondto a collection of information unless it contains a valid OMB control number
`Att
`Docket Numb
`6107-233P/440710
`Application Data Sheet 37 CFR 1.76
`Title of Invention Midstream Urine Collection
`
`
`
`The application data sheetis part of the provisional or nonprovisional application for whichit is being submitted. The following form
`contains the bibliographic data arranged in a format specified by the United States Patent and Trademark Office as outlined in 37 CFR
`1.76. This document may be completed electronically and submitted to the Office in electronic format using the Electronic Filing System
`
`Secrecy Order 37 CFR 5.2
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`L]
`
`Inventor Information:
`
`omy oer Application Number
`(EFS) or the document may be printed and included in a paperfiled application.
`Portionsorall of the application associated with this Application Data Sheet mayfall under a Secrecy Order pursuant to 37 CFR5.2 (Paperfilers only. Applications that fall under Secrecy Order may not befiled electronically.)
`
`
`Inventor
`1
`Legal Name
`
`
`
`
`
`
`Prefix
`
`Middle Name
`
`Family Name
`|Civen Name
`VAROTSIS
`Dante
`Non US Residency
`Residence Information (Select One) X US Residency
`Active US Military Service
`
`
`City Country of Residence|USAPhiladelphia, PA State/Province PA
`
`
`
`
`Mailing Addressof Inventor:
`
`Address 1
`1232 Chestnut St, Apt 4002
`
`Address 2
`
`City
`Postal Code
`
`Philadelphia, PA
`19107
`
`State/Province
`USA
`
`PA
`
` Postal Cod a
`
`
`
`Inventor 2
`
`Legal Name
`
`
`Prefix
`
`Middle Name
`
`uffIX
`
`
`
`
`
`
`Family Name
`|Given Name
`DIFRANCO
`Anthony
`Non US Residency
`Active US Military Service
`Residence Information (Select One) X US Residency
`PA
`Country of Residence
`USA
`City
`Philadelphia, PA
`State/Province
`
`
`Mailing Addressof Inventor:
`
`Address 1
`4329 Terrace St.
`
`Address 2
`
`City
`
`Philadelphia, PA
`
`State/Province
`
`PA
`
`LEGAL\38776376\1
`
`

`

` Address 1
`
`Prefix
`
`Middle Name
`
`UffIX
`
`
`
`
`
`
`
`Family Name
`|Given Name
`Helen
`XU
`
`Residence Information (Select One) X US Residency
`Non US Residency
`Active US Military Service
`City
`Philadelphia, PA
`State/Province
`PA
`Country of Residence
`USA
`
`
`
`
`Inventor 3
`
`Legal Name
`
`Prefix
`
`Middle Name
`
`
`
`
`Family Name
`|Given Name
`NEELY
`Christopher
`Active US Military Service
`Non US Residency
`Residence Information (Select One) X US Residency
`
`City Macungie, PA State/Province | PA Country of Residence | USA
`
`
`
`
`
`
`
`
`
`Mailing Address of Inventor:
`
`
`Address1
`7219 Myrtle Dr
`
`Address 2
`
`
`
`City
`Macungie, PA
`State/Province
`PA
`
`
` Postal Code | 18062 Country USA
`
`
`
`
`Inventor
`4
`Legal Name
`
`Mailing Address of Inventor:
`
`1106 Fitzwater St
`
`Address 2
`PA
`[Philadelphia,PA__—=StatevProvince
`City
`
`Postal Code USA 19147 Country
`
`
`
`CorrespondenceInformation:
`
`Enter either Customer Number or complete the CorrespondenceInformation section below. For further information see 37 CFR
`4.33(a).
`
`| An Addressis being provided for the correspondenceInformation of this application. Customer
`
`Number_—_—_—(27798
`
`Email Address
`nyipdocketing@cozen.com
`
`LEGAL\38776376\1
`
`

`

`Application Information:
`Title of the Invention
`
`Midstream Urine Collection
`
`6107-233P/440710
`Attorney Docket Number
`Provisional
`Application Type
`Utility
`Subject Matter
`(Total Number of Drawing Sheets(if any)
`
`14
`
`
`
`
`
`
`Small Entity Status Claimed: Yes
`
`Suggested Figure for Publication (if any)
`
`Publication Information:
`
`Request Early Publication (Fee required at time of Request 37 CFR 1.219)
`
`Request Not to Publish. | hereby request that the attached application not be published under 35 U.S.C. 122(b) and certify that
`the invention disclosed in the attached application has not and will not be the subject of an application filed in another
`
`country, or under a multilateral international agreement, that requires publication at eighteen monthsafterfiling.
`during processing.
`
`Representative Information:
`
`Representative information should be providedforall practitioners having a powerof attorney in the application. Providing this information in the
`Application Data Sheet does not constitute a powerof attorney in the application (see 37 CFR 1.32). Either enter Customer Numberor complete
`the Representative Name section below.If both sections are completed the customer Numberwill be used for the Representative Information
`
`
`Please Select One:
`°
`Customer Number
`US Patent Practitioner
`Limited Recognition (37 CFR 11.9)
`
`Customer Number
`
`27799
`
`Domestic Benefit/National Stage Information:
`
`This section allowsfor the applicantto either claim benefit under 35 U.S.C. 119(e), 120, 121, or 365(c) or indicate National Stage entry from a
`PCT application. Providing this information in the application data sheet constitutes the specific reference required by 35 U.S.C. 119(e) or 120,
`
`and 37 CFR 1.78.
`
`Prior Application Status
`
`Application Number
`
`Continuity Type
`
`Prior Application Number
`
`Filing Date (YYYY-MM-DD)
`
`
`
`
`
`This section allows for the applicant to claim benefit of foreign priority and to identify any prior foreign application for which priority is not
`claimed. Providing this information in the application data sheet constitutes the claim for priority as required by 35 U.S.C. 119(b)
`
`LEGAL\38776376\1
`
`

`

`Statement under 37 CFR 1.55 or 1.78 for AIA (First Inventor to File) Transition
`
`This application (1) claims priority to or the benefit of an applicationfiled before March 16, 2013 and (2) also contains, or
`contained at any time, a claim to a claimed invention that has an effective filing date on or after March 16, 2013.
`NOTE: By providing this statement under 37 CFR 1.55 or 1.78, this application, withafiling date on or after March 16, 2013,will
`
`be examined underthefirst inventorto file provisions of the AIA.
`
`Authorization to Permit Access:
`
`[]
`
`Authcrization to Permit Accessto the Instant Application by the Participating Offices
`If checked, the undersigned hereby grants the USPTO authority to provide the European Patent Office (EPO), the Japan Patent
`Office (JPO), the Korean Intellectual Property Office (KIPO), the World Intellectual Property Office (WIPO), and any otherintellectual
`property offices in whicha foreign application claiming priority to the instant patent application is filed access to the instant patent
`application. See 37 CFR 1.14(c) and (h). This box should not be checkedif the applicant does not wish the EPO, JPO, KIPO,
`WIPO,orotherintellectual property office in whicha foreign application claimingpriority to the instant patent applicationisfiled to
`have accessto the instant patent application.
`In accordance with 37 CFR 1.1 4(h)(3), accesswill be provided to a copy of the instant patent application with respectto: 1) the
`instant patent application-as-filed; 2) any foreign application to which the instant patent application claims priority under 35 U.S.C.
`1 19(a)-(d) if a copy of the foreign application that satisfies the certified copy requirement of 37 CFR 1.55 has beenfiled in the instant
`patent application; and 3) any U.S. application-as-filed from which benefit is sought in the instant patent application.
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`
`Applicant Information:
`Providing assignmentinformation in this section does not substitute fer compliance with any requirementof part 3 of Title 37 of CFR to have an
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`
`If the applicant is the inventor (or the remaining joint inventor or inventors under 37 CFR 1.45), this section should not be completed.
`The information to be provided in this section is the name and addressof the legal representative who is the applicant under 37 CFR 1.43;or the
`name and addressof the assignee, person to whom the inventor is under an obligation to assign the invention, or person who otherwise shows
`sufficient proprietary interest in the matter who is the applicant under 37 CFR 1.46. If the applicant is an applicant under 37 CFR 1.46 (assignee,
`person to whom theinventoris obligated to assign, or person who otherwise showssufficient proprietary interest) together with one or more
`joint inventors, then the joint inventor or inventors whoare also the applicant should beidentified in this section.
`
`
`Applicant 1
`
`[]
`
`Assignee
`
`
`
`
`
` If the Assignee is an Organization check here.
`
`[ ]
`Person to whom the inventor is obligated to assign.
`[ ] Person who showssufficient proprietary interest
`If applicant is the legal representative, indicate the authority to file the patent application, the inventoris:
`
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`
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`Nameof the Deceased or Legally Incapacitated Inventor:
`
`
`
`[ ]
`_
`
`LEGAL\38776376\1
`
`

`

`Organization Name
`
`Mailing Address Information:
`[Address1
`
`Address 2
`
`
`
`City
`State/Province
`
`
`Country |
`Postal Code
`
`Phone Number
`
`Fax Number Email Address
`
`Signature:
`
`NOTE: This form must be signed in accordance with 37 CFR 1.33. See 37 CFR 1.4 for signature requirements and certifications
`
`Signature
`
`/Carl B. Wischhusen/
`
`Date (YYYY-MM-DD)
`
`
`
`
`
` 2018-10-17
`
`
`
`
`
`
`
`FirstName=|LastName|Wischhusen Registration Number=|43,279 Carl
`
`This collection of information is required by 37 CFR 1.76. The information is required to obtain or retain a benefit by the public
`whichis to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR 1.14.
`This collection is estimated to take 23 minutes to complete,
`including gathering, preparing, and submitting the completed
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`NOT SEND FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450,
`Alexandria, VA 2231 3-1450.
`
`LEGAL\38776376\1
`
`

`

`[00
`
`ZISS
`
`Fig. 1
`
`
`

`

`
`
`Fig. 2
`
`

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`the stream of urine
`fram side & to side B.
`
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`itis adhered to
`the well and rests
`
`an the ridqe.
`
`435 a
`
`ny
`
`Ais
`
`4, Excess Soout
`dispels extra uring”
`not needed for
`sarmpling.
`
`
`
`
`5. Wall that creates a
`
`partition where the bad
`sarnple is quided inta
`side B and disposed of
`via excess spout, The
`clean sample ques inta
`side A,
`
`Fig. 4
`
`

`

`- (00
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`xae
`
`‘‘
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`f Bs
`
`Fig. 5
`
`
`
`

`

`O02. Sponge absorbs
`10ml, weight weakens
`paper, which causes the
`well to flip. Bad sample
`leaks out through excess.
`
`
`
`sf0
`
`
`
`

`

`03. Nurse or
`technician sticks
`centrifuge vile
`onto needle,
`capturing urine
`
`ready for culturing.
`
`rig. 7
`
`

`

`5. Gelluiose sponge
`abserbs 16mi of
`sample. Acis as a
`coumerweight and
`causes trapdoor to flip.
`
`
`
`1, 30 degree trapdoor
`urine well diverts the
`stream from the top
`parilion to tne bottom
`partition.
`
`
`
`
`
`
`
`fo------#--------—---
`
`
`
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`mF
`
`
`
`Fig. 8
`
`

`

`
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`Stream hits cellulose sponge, .
`4.
`which sits on trapdoor.
`
`Fig. 9
`
`

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`22.
`
`2. Paper weakens\due to weight,
`which causes trapcgor to flip.
`
`N27
`
`Fig. 10
`
`

`

`
`
`338
`
`O22.
`
`
`
`
`
`
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`
`3. Urine overflows in top partition = oFO
`and flows into centrifuge vial. Rest
`of urine flows into bottom partition
`and is expelled through excess
`spout.
`
`Fig. 11
`
`

`

`
`
`

`

`
`
`Fig. 13A
`
`Fig. 13B
`
`

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`[200
`
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`
`“(Zoo
`
`
`
`
`
`Fig. 144
`
`Fig. 14B
`
`

`

`
`
`
`
`Attorney Docket Number: 6107-233P/440710
`
`Receipt Date:
`
`17-OCT-2018
`
`Paymentinformation:
`
`Payment Type
`
`CARD
`
`RAM confirmation Number
`
`101818INTEFSW17473700
`
`
`
`The Director of the USPTO is hereby authorized to charge indicated fees and credit any overpayment as follows:
`
`
`
`Electronic Acknowledgement Receipt
`
`ae
`
`a
`
`Title of Invention:
`
`Midstream Urine Collection
`
`
`
`First Named Inventor/Applicant Name: Dante VAROTSIS
`
`Customer Number:
`
`27799
`
`Edward M. Weisz/Marie Mendoza
`Filer:
`
`
`Filer Authorized By:
`
`Edward M. Weisz
`
`

`

`Information:
`
`d5cdb11c3be1c376c1bf1 5a09730ed825ac
`4ce85
`
`
`File Listing:
`
`Document
`Number
`
`Document Description
`P
`
`File Size(Bytes)/
`Message Digest
`
`Multi
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`
`Pages
`(if appl.)
`
`Provisional Cover Sheet (SB16)
`
`6107-233P-Transmittal.pdf
`
`Sdc536be751ec6506cdba0a71585076425}
`7eeda
`
`This is not a USPTO supplied Provisional Cover Sheet SB16 form.
`
`Information:
`
`Application Data Sheet
`
`6107-233P-ADS.pdf
`
`459Se31ce979d2e3b7dSeac7e7df990246b]
`638c0
`
`Information:
`
`
`This is not an USPTO supplied ADS fillable form
`
`Specification
`
`6107-233P-Application.pdf
`
`badSfc020b7ec705816149ceeb02b8ct289
`be
`
`Information:
`
`Drawings-only black and white line
`drawings
`
`6107-233P-Drawings.pdf
`
`665d5 e92Fdf4heSd8a30144563a4b2e7875]
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`
`1654276
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`
`Fee Worksheet (SBO6)
`
`fee-info.pdf
`
`Warnings:
`
`
`
`Total Files Size (in bytes) 1900684
`
`

`

`This Acknowledgement Receipt evidences receipt on the noted date by the USPTO of the indicated documents,
`characterized by the applicant, and including page counts, where applicable.It serves as evidence of receipt similar to a
`Post Card, as described in MPEP 503.
`
`the application.
`
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`

`

`Docket No: (6107-233P-4407100)
`
`MIDSTREAM URINE COLLECTION
`
`FIELD OF THE INVENTION
`
`[0001] The present disclosure generally relates to midstream urine collection and, in
`
`particular, a device for midstream urine collection which uses a rotatable diverter having
`
`an actuation panel with a piece of absorbent material affixed thereto.
`
`BACKGROUND OF INVENTION
`
`[0002] To diagnosea urinary tract infection (UTI) and determine which antibiotic
`
`should be usedfor treatment, a patient’s urine is streaked on an agar plate and
`
`sensitivity analysis is performed. In order to collect a “clean” sample thatis
`
`representative of what is in the bladder and not on the external skin, the patient must
`
`urinate about 10-25 mL into the toilet and then catch some urine in a small plastic cup.
`
`There are multiple error-prone steps in this process, and it is difficult to perform for
`
`many patients, especially women and those with dexterity deficits. A 2007 study showed
`
`that UTIs accounted for 13.5 million office visits and a total cost of $13.5 billion
`
`(including the time lost from work). Before the age of 60, women are more 30 times
`
`more likely to experience a UTI than men (as patients age, the incidence of UTIs among
`
`men and women becomes comparable). Consequently, women constitute 97% of the
`
`UTI population.
`
`[0003] A midstream, clean catch sample is considered ideal for culture and sensitivity
`
`testing of the urine. In practice, however, patients often are not providing adequate
`
`clean catch samples. The ideal process entails many detailed steps and, in many
`
`cases, the patient is either not counseled or is given confusing instructions for providing
`
`an “ideal” sample. Moreover, the instructions given can vary widely among providers.
`
`For women, the process is moredifficult than for men. Women may geturine on their
`
`hand, for example, or may not be able to direct their urine stream. For these reasons
`
`and others, most patients do not adequately collect a clean catch sample.
`
`Contamination is a very common problem in such samples, and it delays evidence-
`
`based decision making. At a typical institution, there may be a contamination rate of 35-
`
`

`

`Docket No: (6107-233P-4407100)
`
`45% for urine samples. Without a sensitivity analysis from culture, the best antibiotic
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`cannot be prescribed, and instead the provider is 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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`SUMMARY OF INVENTION
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`[0004] 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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`[0005] 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 causes the internal partition to flip. This
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`rearrangement redirects 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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`[0006] The device described in the disclosed embodiments makes the processof
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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 method of collecting urine for culture testing.
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`2
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`Docket No: (6107-233P-4407100)
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`[0007] The disclosed embodiments provide a device which improves clinical decision
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`making, decreases urine collection costs, and aligns with the goals of antibiotic
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`stewardship programs. The improved outcomes asa 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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`[0008]
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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 the initial 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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`[0009]
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`In the drawings, identical reference numbersidentify 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 maybearbitrarily 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 shapeof
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`Docket No: (6107-233P-4407100)
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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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`[0010]
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`Fig. 1
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`is a top perspective view of a first embodiment of a midstream urine
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`collection device.
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`[0011]
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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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`[0012]
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`Figs. 3 and 4 are side, hidden line viewsof the first embodiment of the
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`midstream urine collection device.
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`[0013]
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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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`[0014]
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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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`[0015]
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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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`[0016]
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`Fig. 8 is a side, hidden line view of a second embcodiment of a midstream urine
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`collection device.
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`[0017]
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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, the view depicting a first stage of a urine collection process.
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`[0018]
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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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`[0019]
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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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`[0020]
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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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`[0021]
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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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`Docket No: (6107-233P-4407100)
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`[0022]
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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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`[0023]
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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 compartmentin a first position.
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`[0024]
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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 compartmentin a second position.
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`DETAILED DESCRIPTION OF THE EMBODIMENTS
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`[0025]
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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 more of these specific details, or with other methods, components, materials, etc.
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`[0026] The disclosed embodiments relate to devices for clean catch urine collection for
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`microbial culture. The devices are not meant to 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 disposed of in the regular waste, as urine is not considered a
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`biohazard.
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`[0027]
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`Figs. 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 formedof plastic, e.g., injection molded polypropylene, with a generally
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`rounded or oval shape to allow it 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 formed in the bottom 120 of the housing 110 to allow excess urine to be
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`dispelled.
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`[0028]
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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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`Docket No: (6107-233P-4407100)
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`funnel wall 150. The extended lip 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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`[0029] 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 edge of 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 thatit 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 backside of the extraction port 160 and extends down into the
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`midstream collection reservoir 420 (see Fig. 4 and corresponding description below).
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`[0030]
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`Figs. 3 and 4 are side, hidden line viewsof the 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 anda
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`simplified representation of the hinge for ease of description.
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`[0031] 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 serves to 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 whichis dividedinto aninitial 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 formed by a barrier formed in, or installed in, the interior volume (see
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`Fig. 3).
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`Docket No: (6107-233P-4407100)
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`[0032] The interior volume has an upper portion which forms aninitial 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 450 is 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 which is 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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`thatit is positioned at the bottom ofthe initial collection well 430. The deflection panel
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`445 may form an obtuse angle with the actuation panel 450. This arrangement holds 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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`[0033] As explained belo