United States Patent
`
`[19]
`
`Layton et al.
`
`[541
`
`MIDSTREAM SAMPLING DEVICE
`Inventors:
`
`Terry N. Layton, Arlington Heights;
`Carl J. Steigerwald, Wauconda, both
`of Ill.
`
`Assignee:
`
`App]. No.:
`Filed:
`
`The Kendall Company, Boston, Mass.
`102,673
`Dec. 12, 1979
`
`Int. Cl.3 ...................... .. A61B 10/00; GOIN 1/10
`U.S. C1. ............................... .. 128/761; 73/863.52;
`128/762
`Field of Search ........... .. 73/421 R; 128/761, 762,
`128/295; 4/144.3
`
`References Cited
`U.S. PATENT DOCUMENTS
`1/1972
`Linzer et al.
`................... .. 73/421 R
`Cox
`8/1972
`Gleason et al.
`8/1973
`Gleason et al.
`8/1973
`
`3,635,091
`3,680,543
`3,7 50,647
`3.7 50,648
`
`[11]
`
`[45]
`
`4,301,812 -
`
`Nov. 24, 1981
`
`1/1975 Tomasello .................... .. 128/762 X
`3,859,671
`3,929,412 12/1975 Villari
`128/295 X
`4,106,490
`8/1978 Spilman et al.
`128/761
`
`Primmy Examiner—Daniel M. Yasich
`Attorney, Agent, or Firm—Powel1 L. Sprunger
`
`ABSTRACT
`[57]
`A midstream sampling device comprising, a housing
`having a chamber, a distal outer mouth defining an
`outer port, an inner mouth in the chamber defining an
`inner port, and an outlet opening. The housing has a
`first cavity communicating between the inner port and
`the outlet opening, and a second cavity at least partially
`below the inner mouth and communicating with the
`outer port. The housing has an elongated depending
`post having a channel, and an upper aperture communi-
`cating with at least one of the cavities. The device also
`has a receptacle having a chamber communicating with
`the outlet opening.
`
`14 Claims, 15 Drawing Figures
`
`DNA Genotek, Inc. Exhibit 2010 Page 1
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`

`
`US. Patent
`
`Nov. 24, 1981
`
`4,301,812
`
`DNA Genotek, Inc. Exhibit 2010 Page 2
`
`

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`US. Patent
`
`Nov. 24, 1931
`
`Sheet 2 of?»
`
`4,301,812
`
`;r
`
`DNA Genotek, Inc. Exhibit 2010 Page 3
`
`

`
`US. Patent
`
`Nov. 24, 1981
`
`Sheet 3 of3
`
`4,301,812
`
`DNA Genotek, Inc. Exhibit 2010 Page 4
`
`

`
`1
`
`4,301,812
`
`MIDSTREAM SAMPLING DEVICE
`
`BACKGROUND OF THE INVENTION
`
`The present invention relates to midstream sampling
`devices.
`It is frequently desirable to obtain a clean sample of
`urine from a patient for purposes of analysis. A number
`of devices have been proposed for obtaining such a
`sample from male patients, but it has been more difficult
`to obtain a clean sample of urine from a female patient.
`A clean sample requires that the urine not touch a non-
`sterile area, such as the labia in the case of female pa-
`tients. Also, it is desirable to collect the midstream por-
`tion of the urine discharge, since the initial portion of
`the discharge may become contaminated due to retro-
`grade contamination in the urethra.
`SUMMARY OF THE INVENTION
`
`A principal feature of the present invention is the
`provision of an improved device for collecting the mid-
`stream portion of a urine discharge from a female pa-
`tient.
`invention comprises, a
`The device of the present
`housing having a chamber, a distal outer mouth defining
`an outer port, and an inner mouth in the chamber defin-
`ing an inner port generally aligned with the outer port.
`The housing has a first lower proximal outlet opening,
`and a first proximal cavity communicating between the
`inner port and the first outlet opening. The housing has
`a second lower distal outlet opening, and a second distal
`cavity at least partially below the inner mouth and com-
`municating between the outer port and the second out-
`let opening. The housing has a pair of depending elon-
`gated posts adjacent opposed sides of the housing inter-
`mediate the first and second outlet openings, with the
`ports defining a pair of channels extending through the
`posts, and defining a pair of apertures communicating
`between the channels and a lower portion of the first
`and second cavities. The device has a first receptacle
`releasably attached to the housing and having a cham-
`ber in the first receptacle, and a second receptacle re-
`leasably attached to the housing and having a chamber
`in the second receptacle.
`A feature of the present invention is that the outer
`mouth may be positioned inside a labia of a patient to
`capture a urine sample without contamination by the
`labia.
`Another feature of the invention is that the initial
`portion of the discharge passes through the second
`cavity to the second outlet opening due to its relatively
`low velocity.
`Yet another feature of the invention is that the second
`receptacle communicates with the second outlet open-
`ing to capture the initial portion of the urine discharge.
`A further feature of the invention is that the mid-
`stream portion of the discharge passes through the inner
`mouth due to its relatively high velocity.
`Still another feature of the invention is that the first
`receptacle communicates with the first outlet opening
`to capture the midstream portion of the urine discharge.
`A further feature of the invention is that overflow of
`liquid from the first or second receptacle passes through
`the apertures into the posts and out of the housing.
`A feature of the present invention is that the overflow
`liquid is disposed of through the posts without wetting
`the first or second receptacle.
`
`5
`
`15
`
`65
`
`2
`Further features will become more fully apparent in '
`the following description of the embodiments of this
`invention and from the appended claims.
`DESCRIPTION OF THE DRAWINGS
`
`_
`
`In the drawings:
`FIG. 1 is a side elevational view showing a housing of
`a midstream sampling device of the present invention;
`FIG. 2 is a rear elevational view of the housing of
`FIG. 1;
`FIG. 3 is a front elevational view of the housing of
`FIG. 1;
`FIG. 4 is a lower plan view of the housing of FIG. 1;
`FIG. 5 is a fragmentary sectional view of the housing
`of FIG. 1;
`FIG. 6 _is a sectional view taken substantially as indi-
`cated along the line 6--6 of FIG. 5;
`FIG. 7 is a sectional View taken substantially as indi-
`cated along the line 7—7 of FIG. 5;
`FIG. 8 is a sectional view taken substantially as indi-
`cated along the line 8-8 of FIG. 5;
`FIG. 9 is a fragmentary elevational view of the hous-
`ing of FIG. 1 and a pair of receptacles which are releas-
`ably attached to the housing;
`FIGS. 10 and 11 are elevational views, partly broken
`away, of preformed halves which may be assembled
`into the housing of FIG. 1;
`,
`FIG. 12 is a perspective view of an inner mouth fo
`the housing of FIGS. 10 and 11;
`FIG. 13 is a perspective view of another embodiment
`of the mouth of FIG. 12;
`V
`FIG. 14 is a fragmentary elevational view illustrating
`the device with the mouth of FIG. 13; and
`FIG. 15 is a lower view taken substantially as indi-
`cated along the line 15-15 of FIG. 14.
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`Referring now to FIGS. 1-9, there is shown a mid-
`stream sampling device generally designated 20 lizwing
`a housing 22 and first and second receptacles 24 (FIG.
`14) and 26 (FIG. 9), respectively. The housing 22 has an
`outer wall 28 defining an internal chamber 30, and a
`distal outer oval mouth 32 defining an outer port 34. In
`a preferred form, the outer wall 28 is recessed adjacent
`the outer mouth 32 to receive a resilient bumper mem-
`ber 36 extending peripherally around the outer port 34,
`as shown. The housing 22 has an outwardly and up-
`wardly extending proximal portion defining a handle 38
`for the device during use. The housing may be made
`from a suitable material, such as plastic, and the bumper
`member 36 may be constructed from rubber.-
`The housing 22 has an inner mouth 40 generally
`aligned with the outer mouth 32 and defining an inner
`port 42. The housing has a ledge 44 extending from a
`lower portion of the inner mouth 40 to a central portion
`of a lower wall 46 of the housing. The lower wall 46 has
`a first proximal depending tubular extension 48 defining
`a first proximal outlet opening 50, and a more distal
`second depending tubular extension 52 defining a sec-
`ond distal outlet opening 54. As shown, the inner mouth
`40 and ledge 44 define a first cavity 56 extending be-
`tween the inner port 42 and first outlet opening 50, and
`a second cavity 58 partially below the inner mouth 40
`and communicating between the outer port 34 and the
`second outlet opening 54.
`The housing 22 has a pair of hollow equal-length
`depending posts 60 located adjacent opposed sides of
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`4,301,812
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`the housing and located intermediate the first and sec-
`ond outlet openings 50 and 54, respectively. The posts
`60 each have a chamiel 62 extending through the posts
`60, with the lower wall 46 defining respective apertures
`64 communicating with the channels 62. As shown, the
`ledge 44 has a proximal end portion separating the aper-
`tures 64 into a first portion communicating with the first
`cavity 56 and a second portion communicating with the
`second cavity 58. The housing 22 has a distal depending
`post 66 having a length approximately equal
`to the
`length of the posts 60 and located adjacent the second
`outlet opening 54. The posts 60 and 66 may be utilized
`to support the device 20 on a suitable flat surface when
`not in use. Also, as shown, the ledge 44 has a depending
`stop member 68 extending across the housing 22 in the
`second cavity 58 centrally above the second outlet
`opening 54.
`With reference to FIGS. 10-12, the housing 22 of the
`present invention may be constructed in a simplified
`manner from first and second half members 7021 and 70b,
`respectively. As shown, the inner mouth 40 has a some-
`what annular mouth member 72 defining the port 42,
`and an outwardly directed flange 74 extending from the
`mouth member 72. The half members 700 and b have a
`pair of slanted grooves 76 to receive the flange 74 of the
`inner mouth 40, and have a plurality of inwardly di-
`rected pegs 78 to hold the flange 74 of the inner mouth
`40 in place. The first half member 70a has a plurality of
`apertures 80 to receive a plurality of associated pegs 82
`extending from the second half member 70b. Also, the 30
`first half member 700 has a pair of grooves 84 to receive
`a corresponding pair of ridges 85 on the second half
`member 701). Thus, the inner mouth 40 may be posi-
`tioned on one of the half members 70a or 70b, and the
`half members 70a and b may be closed about the inner
`mouth, and may be cemented in place to form the hous-
`ing 22 through use of a suitable adhesive.
`With reference to FIG. 9, the first receptacle 24 has a
`chamber 86, an upper threaded neck 88, and a tapered
`wall 90. The second receptacle 26 also has a chamber
`92, an upper threaded neck 94, and a tapered wall 96.
`The first receptacle 24 may be releasably attached to the
`first tubular extension 48 which is snugly received in the
`first receptacle neck 88, such that the inner port 42
`communicates with the first receptacle chamber 86
`through the first cavity 56 and first outlet opening 50.
`The second receptacle 26 may be rcleasably attached to
`the second tubular extension 52 which is snugly re-
`ceived in the neck 94 of the second receptacle 26, with
`the outer port 34 communicating with the chamber 92
`of the second receptacle 26 through the second cavity
`58 and second outlet opening 54. With reference to
`FIGS. 1-9, the aligned posts 60 have a generally triang-
`ular shape in cross-section, with the vertices of the
`triangles being directed toward each other. Thus, the
`first and second receptacles 24 and 26 may be secured to
`the housing 22 with the posts 60 located intermediate
`the opposed sides of the receptacles 24 and 26, and with
`the walls 90 and 96 of the first and second receptacles 24
`and 26, respectively, facing toward the posts 60. Also,
`the second receptacle is secured to the housing 22 at a
`location intermediate the distal post 66 and the posts 60.
`The receptacles 24 and 26 have a length slightly less
`than the posts 60 and 66 when they are secured to the
`housing 22, such that the housing 22 rests upon the posts
`60 and 66 when it is placed on a surface, with the recep-
`tacles 24 and 26 being frictionally engaged to the first
`and second tubular extensions 48 and 52, respectively.
`
`ll
`With reference to FIG. 9, the first and second recepta-
`cles 24 and 26 may have a suitable cap 98 which may be
`secured to the necks of the receptacles by the threads on
`the necks.
`In use, the first and second receptacles 24 and 26 are
`secured to the first and second tubular extensions 48 and
`52 of the housing 22. Next, the labia are spread by the
`user, and the outer mouth 32 is placed within the labia
`at a location with the outer port 34 positioned to receive
`urine passing from the urethra, with the bumper mem-
`ber 36 providing comfort for the patient in this configu-
`ration. The sampling device 20 is positioned by the
`patient while sitting upon the toilet. When urination has
`started, the initial portion of the urine discharge passes
`through the outer port 34 into the second cavity 58, due
`to its relatively low velocity, and the stop member 68
`directs the initial portion of the discharge through the
`second outlet opening 54 into the chamber 92 of the
`second receptacle 26. In the event that the second re-
`ceptacle 26 overllows,
`the overflowing liquid passes
`from the second outlet opening 54 to the apertures 64,
`and through the channels 62 of the posts 60 into the
`toilet.
`As the discharge continues, the midstream portion
`thereof passes through the inner port 42 due to its rela-
`tively large velocity, and through the first cavity 56 and
`first outlet opening 50 into the chamber 86 of the first
`receptacle 24 for collection therein. In the event that
`the first receptacle 24 overflows, the overflowing liquid
`passes from the first outlet opening 50 to the apertures
`64, and through the channels 62 of the posts 60 into the
`toilet. Thus, overflowing urine from either of the cavi-
`ties 56 or 58 is directed by the posts 60 into the toilet to
`prevent wetting of the outside of the receptacles in the
`event of an overflow condition. Also, the initial portion
`of the discharge, which may be contaminated clue to
`retrograde contamination in the urethra, is collected in
`the second receptacle 26 which may be discarded, if
`desired. The clean midstream portion of the discharge is
`collected in the first receptacle 24, and a cap 98 may be
`secured to the top of the first receptacle 24 to save the
`midstream specimen for subsequent analysis.
`Another embodiment of the present invention is illus-
`trated in FIGS. 13-15, in which like reference numerals
`designate like parts. In this embodiment,
`the mouth
`member 72 has a web 100 extending across the inner
`port 42. Also, the first and second tubular extensions 48
`and 52 may have external bosses 102 to facilitate the
`frictional engagement between the tubular extensions
`and the receptacles. In other respects,
`the device of
`FIGS. 13—I5 is similar to the device previously de-
`scribed in connection with FIGS. 1-12.
`The foregoing detailed description is given for clear-
`ness of understanding only, and no unnecessary limita-
`tions should be understood therefrom, as modifications
`will be obvious to those skilled in the art.
`‘We claim:
`1. A midstream sampling device for collecting the
`midstrcam portion of a urine discharge from a female
`patient, comprising:
`a housing defining a chamber
`therewithin, said housing being structured to be sup-
`ported on a horizontal surface when not in use; means
`defining an outer port at one end of said housing, said
`port having a generally oval shape and being config-
`ured to be placed against the labia of a female and re-
`ceive urine passing from the uretha; means defining an
`inner port within said chamber, said inner port being
`smaller than said outer port and being arranged adja-
`
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`4,301,812
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`5
`cent thereto to receive the midstream portion of a urine
`discharge; means defining a first cavity within said
`housing and including a portion of said housing, said
`first cavity being connected to and in fluid communica-
`tion with said inner port for initial collection of the
`midstream discharge; a first outlet port within said first
`cavity through which the midstream discharge flows; a
`receptacle detachably connected to said first outlet port
`for receiving the midstream discharge from said first
`cavity; means defining a second cavity and including
`another portion of said housing, said second cavity
`arranged to receive the initial portion of a urine dis-
`charge through said outer port, from the lower portion
`of the space between said outer port and said inner port;
`and means defining at
`least one overflow aperture
`within said first cavity whereby, during use of said
`sampling device and upon filling of said receptacle,
`excess urine within said first cavity will drain from said
`first cavity through said aperture.
`2. The device of claim 1 wherein said housing further
`includes a handle thereon, at an end opposite said outer
`port, to facilitate manual positioning of said device to
`receive a urine discharge.
`3. The device of claim 1 wherein said means defining
`at least one overflow aperture comprises a pair of aper-
`tures formed in said first and second cavities, each aper-
`ture communicating with both of said cavities thereby
`to receive a urine discharge overflow from either or
`both of said cavities, said device further comprising a
`pair of elongated, depending posts, one for each aper-
`ture and surrounding its corresponding aperture, each
`said post being hollow and having an open channel
`defined therethrough to direct a urine discharge over-
`flow out of said sampling device.
`4. The device of claim 3 wherein said second cavity
`further includes a second outlet part through which the
`initial portion of a urine discharge flows, said device
`further comprising a second receptacle detachably con-
`
`6
`nected to said second outlet port for receiving the initial
`portion of a urine discharge from said second cavity.
`5. The device of claim 4 wherein the posts are located
`intermediate the sides of the first and "second receptacles
`when the receptacles are attached to the housing.
`6. The device of claim 5 wherein the posts have a
`generally triangular shape in cross section.
`7. The device of claim 6 wherein vertices of the tri-
`angular shaped posts are directed toward each other.
`8. The device of claim 5 wherein the housing includes
`an elongated third depending post, and in which the
`second receptacle is located intermediate the pair of
`posts and the third post when the second receptacle is
`attached to the housing, the lower ends of all three posts
`being configured to support the housing upright on a
`horizontal_ surface when the device is not in use.
`9. The device of claim 4 wherein the first and second
`receptacles include upper necks, and in which the hous-
`ing has a pair of spaced depending tubular extensions
`defining said first and second outlet openings, said necks
`releasably engaging said tubular extensions when the
`first and second receptacles are attached to the housing.
`10. The device of claim 4 wherein said apertures are
`located intermediate the first and second openings.
`11. The device of claim 10 including a stop member
`extending over the second outlet opening separating the
`second cavity over the second outlet opening and inter-
`mediate the outer port and said apertures.
`12. The device of claim 4 wherein the housing in-
`cludes a ledge extending from a lower portion of said
`inner port and separating said first and second cavities.
`13. The device of claim 12 wherein said housing in-
`cludes a lower wall defining the apertures and said first
`and second outlet openings.
`14. The device of claim 13 wherein said ledge extends
`to said lower wall across said apertures, said ledge sepa-
`rating said apertures into a first portion connected to the
`first cavity and a second portion connected to said sec-
`ond cavity.
`It
`I!
`It
`i
`It
`
`DNA Genotek, Inc. Exhibit 2010 Page 7