United States Patent
`
`[19]
`
`Layton
`
`[11]
`
`[45]
`
`4,131,016
`
`Dec. 26, 1978
`
`[54] PEAK FLOW MEASURING DEVICE
`
`[75]
`
`Inventor:
`
`Terry N. Layton, Wheeling, Ill.
`
`[73] Assignee:
`
`The Kendall Company, Boston, Mass.
`
`[21] Appl. No.: 849,747
`
`[22] Filed:
`
`Nov. 9, 1977
`
`....................... GOIF 1/20
`Int. Cl.2 ......................
`[51]
`[52] U.S. Cl. ...................................... 73/215; 128/2 F;
`128/295
`[58] Field of Search ............... .. 73/194 R, 215, 421 R;
`I16/117 R; 128/2 F, 295
`
`[56]
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`2,648,981
`3,859,671
`3.859.854
`3,871,231
`
`8/1953 Drake ..................................... 73/215
`1/1975
`1/1975
`3/1975
`
`Primary Examiner—Herbert Goldstein
`Attorney, Agent, or Firm—Powell L. Sprunger
`
`ABSTRACT
`[57]
`A device for measuring the peak flow rate of a urine
`discharge comprising, a hollow receptacle having a
`chamber, an inlet port for passage of the discharge into
`the chamber, and an outlet port for passage of the dis-
`charge from the chamber at a predetermined flow rate.
`The device has a collection container having a closed
`bottom, a cavity, and an opening adjacent an upper end
`of the container. The receptacle has an aperture in a
`lower wall of the receptacle to removably receive the
`container with the container opening located a prede-
`termined height above the receptacle lower wall in the
`chamber, such that the discharge passes from the cham-
`ber into the container cavity at a predetermined height
`of the liquid in the receptacle chamber.
`
`8 Claims, 4 Drawing Figures
`
`DNA Genotek, Inc. Exhibit 2009 Page 1
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`

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`U.S. Patent
`
`Dec. 26, 1978
`
`4,131,016
`
`__ __ ..1l..
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`DNA Genotek, Inc. Exhibit 2009 Page 2
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`PEAK FLOW MEASURING DEVICE
`
`BACKGROUND OF THE INVENTION
`
`The present invention relates to a device for measur-
`ing a discharge of urine.
`In the past, it has been found desirable to obtain vari-
`ous data pertaining to a liquid discharge. In particular, it
`was discovered that many urological problem could be
`readily diagnosed by analyzing information obtained
`during the natural voiding of urine by patients. Pres-
`ently, various types of devices are utilized to obtain data
`on the urine stream, such as total volume, average flow
`rate, force, velocity, and configuration of the stream.
`Most of these devices have suffered from less than
`total reliability because they have required the presence
`of one or more observers while the patient is voiding. It
`is obvious that administration of such devices in this
`manner creates sufficient psychological difficulties for
`many of the patients to effect voiding. Consequently, if
`the patients void at all, the potentially erroneous data
`‘obtained may result in a false diagnosis and a loss of
`confidence in the device by the physician. A further
`complication arises from the fact that many of these
`devices are rather bulky, and somewhat difficult to use.
`SUMMARY OF THE INVENTION
`
`A principal feature of the present invention is the
`provision of a device of simplified construction for
`measuring a discharge of urine, and which may be self-
`administered by a patient.
`The device of the present invention comprises, a
`hollow receptacle having sidewalls at least partially
`defining a chamber, a lower wall having an aperture, an
`inlet port adjacent an upper end of the receptacle and
`communicating with the chamber to receive the dis-
`' —.charge for passage into the chamber, and an outlet port
`adjacent a lower end of the receptacle and communicat-
`ing with the chamber for passage of the discharge at a
`predetermined rate out of the chamber. The device has
`a collection container having a closed bottom, an elon-
`gated generally tubular section defining a collection
`cavity in the container, and an opening adjacent an
`upper end of the container communicating with the
`cavity. The container is removably received in the re-
`ceptacle aperture with the container opening spaced a
`predetermined distance above the lower receptacle wall
`in the receptacle chamber, and with the receptacle seal-
`ingly engaging against an outer surface of the container.
`A feature of the present invention is that the urine
`discharge collects in the receptacle chamber, and passes
`from the chamber into the container cavity if and only
`if the peak flow rate of the discharge is greater than a
`predetermined value.
`Another feature of the invention is that the device
`thus provides a discrete indication whether the peak
`flow rate of the urine discharge is above or below a
`predetermined value as determined by passage or non-
`passage respectively of the discharge into the container
`cavity.
`A further feature of the invention is that the predeter-
`mined peak flow rate value is established by the height
`of the container opening in the chamber, and the dis-
`crete peak flow rate value may be preselected by adjust-
`ing the height of the container opening in the receptacle
`chamber.
`Thus, a feature of the present invention is that the
`device may be utilized to assess the patient’s ability to
`
`2
`void by determining whether the peak flow rate of the
`discharge is above or below the predetermined value.
`Another feature of the invention is that the device
`may be self-administered by the patient.
`Still another feature of the invention is that the con-
`tainer may be removed from the receptacle after void-
`ing to provide a convenient specimen of urine for analy-
`sis.
`
`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 fragmentary perspective view, partly
`broken away, of a urine measuring device of the present
`invention;
`FIG. 2 is a fragmentary view, taken partly in section,
`illustrating a lower pa.rt of a receptacle in the device of
`FIG. 1 and a container to receive accumulated urine
`above a predetermined peak flow rate of a urine dis-
`charge;
`FIG. 3 is a fragmentary sectional view of the device
`of FIG. 2 illustrating passage of accumulated urine into
`the container responsive to a peak flow rate above the
`predetermined amount; and
`FIG. 4 is a fragmentary elevational view, taken partly
`in section, of the device illustrating use of the container
`for handling a urine specimen.
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`Referring now to FIGS. 1-3, there is shown a device
`generally designated 20 for measuring the peak flow
`rate of a urine discharge. The device 20 has a hollow
`receptacle generally designated 22 having sidewalls 24
`and a lower wall 26 defining a chamber 28 in the recep-
`tacle 22. The receptacle 22 has an aperture 30 defined
`by a flange 32 depending from the receptacle lower
`wall 26, with the flange 32 having a sealing ring 34
`extending peripherally around the aperture 30. The
`receptacle 22 also has an inlet port 36 adjacent an upper
`end 38 of the receptacle, and a diverting plate 40 below
`the inlet port 36 to direct the incoming discharge into
`the chamber 28 away from the receptacle aperture 30.
`The receptacle 22 has a tubular section 42 depending
`from the receptacle lower wall 26 and defining an outlet
`port 44 communicating with the chamber 28 and con-
`trolling passage of liquid fromthe receptacle chamber
`28 at a predetermined flow rate.
`With reference to FIG. 1, the device 20 may also
`have a collection bag generally designated 46 having
`flexible sidewalls 48 defining a cavity 50 in the bag. The
`bag 46 has an upper opening 54 to releasably receive the
`receptacle tubular section 42 such that the receptacle
`outlet port communicates with the bag cavity 50 for
`passage of the urine at a predetermined flow rate from
`the receptacle chamber 28 into the bag cavity 50. If
`desired, the bag 46 may have a cap 52 to close the bag
`opening 54 when the bag is removed from the recepta-
`cle, with the cap 52 being connected by a strap 56 to the
`bag 46. If desired, the bag sidewalls 48 may be made
`from a transparent plastic material, and may have indi-
`cia I on an outer surface of the sidewalls 48 to provide
`an indication of the volume of urine collected in the bag
`cavity 50.
`With reference to FIGS. 1-3, the device 20 also has a
`collection container or vial generally designated 58
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`DNA Genotek, Inc. Exhibit 2009 Page 3
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`4,131,016
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`having a transparent cylindrical sidewall 60 and a bot-
`tom wall 62 defining a cavity 64 in the container, with
`the container sidewall 60 defining an opening 66 at the
`top or upper part of the vial. As shown, the container 58
`may have a cap 68 having an annular sidewall 70 and
`top wall 72 defining a recess 74 in the cap 68 which is
`dimensioned to snugly and releasably receive a lower
`part 76 of the vial 58. With reference to FIG. 2, the vial
`58 may have calibrated indicia I’ on an outer surface 78
`of the sidewall 60 for use in positioning the vial 58in the
`receptacle 22, and for use in connection with the vol-
`ume of urine which may eventually be collected in the
`vial cavity 64.
`As shown in FIGS. 1-3, the vial 58 is slidably re-
`ceived in the receptacle aperture 30 with the receptacle
`sealing ring 34 sealingly engaging against the outer
`surface 78 of the vial to prevent passage of liquid
`through the aperture 30 between the receptacle and the
`vial. The longitudinal position of the vial 58 in the re-
`ceptacle aperture 30 may be adjusted to modify the
`height of the vial opening 66 above the receptacle lower
`wall 26 and the lower part of the chamber 28.
`In use of the device, the cap 52 of the collection bag
`46 is removed from the opening 54, and the bag 46 is
`attached to the receptacle tubular extension 42. In addi-
`tion, the collection vial 58 is placed in the receptacle
`aperture 30 with the vial opening 66 located at a desired
`height in the chamber 28 as detennined by the indicia I’
`to provide a preselected peak flow rate value of the
`urine discharge, as will be further discussed below.
`The inlet port 36 of the receptacle 22 is then posi-
`tioned by a patient in privacy to receive the discharge of
`urine. With reference to FIG. 2, as the liquid discharge
`passes through the port 36 into the receptacle chamber
`28 it begins to collect in the lower part of the receptacle
`chamber 28 and pass through the outlet port 44 into the
`collection bag 46. As previously indicated, the tubular
`section 42 defining the outlet port 44 establishes a pre-
`determined flow rate of the liquid discharge from the
`receptacle chamber 28, and if the flow rate of urine
`through the outlet port 44 is greater than the flow rate
`of the urine discharge into the receptacle, the urine will
`pass into the collection bag 46 without accumulating
`significantly in the receptacle chamber. Thus, under
`such a condition of relatively low discharge flow rate,
`the urine which accumulates in the receptacle chamber
`28 will not attain the height of the vial opening 66 as-
`suming that it has been positioned a sufficient height
`above the receptacle lower wall 26.
`However, in the normal case, the flow rate of the
`urine discharge passing into the receptacle chamber 28
`will be greater than the predetermined flow rate of the
`accumulated discharge through the outlet port 44, such
`that the height of collected liquid in the receptacle
`chamber 28 will rise as the discharge passes into the
`receptacle. In the event that the peak or maximum flow
`rate is less than the predetermined value, the height of
`accumulated liquid in the receptacle chamber 28 will
`not reach the level of the vial opening 66 which has
`been set at a predetermined distance above the con-
`tainer lower wall 26. In this case, the liquid will accu-
`mulate to a maximum height in the receptacle chamber
`28 below the vial opening 66, and all of the liquid will
`eventually pass through the outlet port 44 of the recep-
`tacle 22 as voiding ceases and the height of collected
`liquid in the chamber 28 abates.
`In the event that the peak flow rate of the urine dis-
`charge is greater than the predetermined amount, the
`
`4
`height of liquid in the receptacle chamber 28 rises above
`the level of the vial opening 66, such that the liquid
`begins to pass through the vial opening 66 into the vial
`cavity 64, as iflustrated in connection with FIG. 3.
`Thus, passage of urine from the chamber 28 into the vial
`cavity 64 during voiding provides an indication that the
`peak flow rate of the urine discharge is greater than a
`predetermined value as determined by the height ad-
`justment of the vial opening 66 in the receptacle 22.
`10 Accordingly, passage or non-passage of the urine dis-
`charge into the vial provides a discrete indication
`whether the peak flow rate of the urine discharge is
`respectively greater or less
`than a predetermined
`amount. The device 20 may thus be utilized to diagnose
`patients for possible further treatment by determining
`whether the peak flow rate of the patient’s urine dis-
`charge is greater or less than a desired value.
`After voiding by the patient has ceased, the collected
`urine in the receptacle chamber 28 drains through the
`outlet port 44 into the collection bag 46. If desired, the
`approximate total volume of collected urine in the bag
`46 may be determined by the indicia I on the bag. Fur-
`ther, assuming that the peak flow rate of the patient’s
`discharge was greater than the predetermined amount
`such that urine passed into the collection via], the via]
`58 may be removed from the receptacle 22, as illus-
`trated in connection with FIG. 4, and a specimen of
`urine is thus located in the vial cavity for convenient
`access. The cap 68 may be removed from the lower part
`of the vial and placed over the upper part of the vial to
`cover the vial opening 66 and retain the specimen for
`later analysis, if desired. Alternatively, if the peak flow
`rate of the discharge was less than the predetermined
`value such that the urine did not pass into the vial 58,
`the collection bag 46 may be removed from the recepta-
`cle 22, and a specimen may be obtained through the bag
`opening 54.
`Thus, in accordance with the present invention, the
`device 20 provides a discrete indication whether the
`peak flow rate of a patient’s discharge is greater or less
`than a predetermined value as detemiined through suit-
`able adjustment of the vial in the receptacle. Further,
`the device provides a convenient sample of the urine for
`subsequent analysis, if desired.
`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.
`I claim:
`1. A device for measuring a urine discharge, compris-
`mg:
`v
`a hollow receptacle having sidewalls at least partially
`defining a chamber, a lower wall having an aper-
`ture communicating between the chamber and
`atmosphere, an inlet port adjacent an upper end of
`the receptacle and communicating with the cham-
`ber to receive the discharge for passage into the
`chamber, and an outlet port adjacent a lower end
`of the receptacle and communicating with the
`chamber for passage of the discharge at a predeter-
`mined rate out of the chamber;
`collection container having a closed bottom, an
`elongated generally tubular section defining a col-
`lection cavity in the container, and an opening
`adjacent an upper end of the container communi-
`cating with said cavity, said container being re-
`movably received in the receptacle aperture with
`the container opening spaced a predetermined dis-
`
`55
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`DNA Genotek, Inc. Exhibit 2009 Page 4
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`4,131,016
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`in said
`tance above the lower receptacle wall
`chamber, and with the receptacle sealingly engag-
`ing against a surface of the container in the region
`of said aperture, such that the discharge passes
`from the receptacle chamber through the container
`opening into said cavity at a predetermined height
`of the liquid in said chamber to provide a discrete
`indication of the discharge peak flow rate and a
`specimen of the discharge in said cavity for analysis
`upon removal of the container from the receptacle.
`2. The device of claim 1 including a cap for releasable
`attachment to an upper part of said container and clo-
`sure of said opening.
`3. The device of claim 1 wherein said cap is releasably
`attached to the bottom of said container in a storage
`position when the container is received in the receptacle
`aperture.
`
`5
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`10
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`4. The device of claim 1 including a collection bag
`communicating with said receptacle outlet port to re-
`ceive the discharge passing from the outlet port.
`5. The device of claim 1 wherein said receptacle
`includes a sealing ring sealingly engaging the outer
`surface of the container peripherally around said aper-
`ture.
`6. The device of claim 1 wherein said container is
`adjustably positioned in said receptacle aperture to
`modify the height of the container opening above the
`receptacle lower wall.
`V
`7. The device of claim 1 wherein the‘ receptacle in-
`cludes means for directing the incoming discharge
`away from the container opening.
`'
`8. The device of claim 1 wherein the container com-
`prises a vial having a cylindrical sidewall defining the
`cavity, a bottom wall closing a lower end of the cavity,
`and the opening defined by the top of the sidewall.
`t
`t
`l
`i
`it
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`DNA Genotek, Inc. Exhibit 2009 Page 5