`
`[19]
`
`[11] Patent Number:
`
`4,728,324
`
`Steigerwald et al.
`
`[45] Date of Patent:
`
`Mar. 1, 1988
`
`[75]
`
`[54] URINE METER VALVE WITH TAMPER
`INDICATOR
`Inventors: Carl J. Steigerwald Fox River
`Grove; Terry N. Léyton, Arlington
`Heights: 130“! Of 111-
`B t
`: Th
`C
`A -
`e Kendall ompany’ Os on
`sslgnee
`Appl. No.: 919,290
`
`, M _
`ass
`
`Filed:
`
`Oct. 15, 1986
`
`Int. Cl.4 ............................................... A61M 1/00
`U.S. Cl. .................................... 604/323; 128/766;
`604/335; 604/318; 251/7
`Field of Search .................... 604/33, 34, 322-325,
`604/335 350 91 110 111 318_ 116/200 277_
`137/553, 251/4 7, 128/200.” 760 762 764
`’
`’
`’
`’ 766’, 767’, 771’
`
`_
`Refemnces Clted
`U.S. PATENT DOCUMENTS
`
`1/1977 Hanifl .................................. 123/771
`4,000,649
`4,018,224 4/1977 Kurtz et al. ......................... 604/321
`
`4,305,403 12/1981 Dunn ................................... 604/323
`FOREIGN PATENT DOCUMENTS
`
`2900806 7/1980 Fed. Rep. of Germany ...... 128/771
`Primary Examiner—C. Fred Rosenbaum
`Assistant Examiner——J. L. Kruter
`Attorney, Agent, or Firm——Donald N. Halgren
`[57]
`ABSTRACT
`
`A multiple sample valve assembly for a urine collection
`system with a valve for taking small urine samples in a
`safe manner. The valve also has a valve for taking large
`“me Smples While having 3 f’a“=‘=’“’1° P°“i°“ f°’ indi‘
`cating that the large sampling valve was used, so as to
`alert medical personnel to the possibility of contamina-
`tion or infection if proper procedures are not under-
`taken. The element for indicating use comprises frangi-
`ble panels or bands which may be disturbed by opening
`the valve.
`
`13 Claims, 3 Drawing Figures
`
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`ACTA EX. 1019-001
`
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`
`ACTA Ex. 1019-001
`
`
`
`U.S. Patent Mar. 1,1988
`
`Sheet 1 of2
`
`4,728,324
`
`ACTA EX. 1019-002
`
`ACTA Ex. 1019-002
`
`
`
`U.S. Patent Mar. 1, 1988
`
`Sheet 2 of 2
`
`4,728,324
`
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`
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`
`ACTA Ex. 1019-003
`
`
`
`4,728,324
`
`1
`
`URINE METER VALVE WIT]-I TAMPER
`INDICATOR
`
`BACKGROUND OF THE INVENTION
`
`(1) Field of the Invention
`The present invention relates to a closed system uri-
`nary drainage bag, and more particularly to tamper
`evident drain valve arranged on a urine meter disposed
`on the front of an urine collection bag.
`(2) PRIOR ART
`Urine collection begins after catheterization of a pa-
`tient, wherein urine drains from the bladder, through a
`catheter and drainage tube connected to the catheter,
`and into a urine collection system. The urine collection
`system generally comprises a urine bag, and a urine
`meter. A urine collection bag, for example, is shown in
`U.S. Pat. No. 4,465,484. A urine collection system with
`a holding chamber and a one way valve is shown in U.S.
`Pat. No. 4,460,362. These urine collection systems did
`not fully provide for metering capabilities and which
`permitted small samples to be taken while limiting the
`likelihood of retrograde infection or bacterial contami-
`nation within the metering chamber.
`U.S. Pat. No. 4,305,405 shows a urine collection bag
`with a meter attached thereto. The meter has a sampling
`port thereon. The meter however fails to permit sam-
`ples to be taken from the meter in such a quantity such
`as 30 to 40 ml. for tests for specific gravity or the like.
`U.S. Pat. Nos. 3,683,894 and 4,305,403 disclose valves
`for urine collection systems. U.S. patent application
`Ser. No. 780,042 discloses tamper (or use) evident
`means disposed on a catheter in a urinary collection
`system.
`It is an object of the present invention to provide a
`urine meter with a drain valve thereon which will per-
`mit both means for taking small fresh samples such as
`with a syringe, while permitting larger fresh volumes to
`be removed from the urine source i.e., the meter, by
`opening of the drain valve. It is a further object of the
`invention to provide sampling ports which will mini-
`mize retrograde'contamination of the fluid within the
`meter and hence within the system and ultimately the
`patient.
`It is a further object of the present invention to pro-
`vide a drain valve on a urine meter which drain valve
`has tamper evident means thereon so as to discourage
`use of the large volume drain valve for small volume
`usage.
`
`BRIEF SUMMARY OF THE INVENTION
`
`The present invention comprises a use or tamper
`evident valve with a combined urine output meter and
`a drainage bag for collecting, measuring and sampling
`urine output from a catheterized patient. The present
`invention permits small samples of fresh urine to be
`taken from the meter as well as permitting large samples
`to be taken from the meter when larger volumes of
`urine are required.
`The urine meter comprises a receptacle having a wall
`defining a cavity and an opening at the top receptacle
`for communication with the cavity. A valve is disposed
`at the bottom of the meter body. A conduit is disposed
`through the bottom of the meter body and is in fluid
`communication with the valve thereat. The valve com-
`prises a generally longitudinally extending housing hav-
`ing an adapter opening at its upper end into which the
`conduit extends. The valve has an opening at its lower
`
`2
`end. A resilient, flexible tube is disposed within the
`generally longitudinal housing of the valve and is in
`overlapping relationship with the adapter which mates
`with the conduit from the bottom of the meter body.
`The housing for the valve, has a front side and a back
`side; A biased slider plunger extends through an open-
`ing in the front side of the housing and is movable trans-
`versely across the body of the valve. An opening
`through the slider permits the flexible conduit to pass
`therethrough. A pair of wall members are disposed on
`either side of the slider. The wall members define the
`opening therethrough to permit the flexible conduit to
`pass. A biasing means such as a spring is disposed
`against the front wall of the housing and a tab on the
`distalmost portion of the slider. The spring acts as bias-
`ing means which causes the proximal end of the slider to
`pinch the flexible conduit against a bracket arrangement
`on the housing and thus close the conduit off.
`A sampling port is disposed between the slider and
`the body of the urine meter. An opening comprising the
`port is disposed in the upper half of a front portion of
`the valve body or housing. A septum, or rubber plug, is
`disposed over the opening.
`The septum permits sampling of minute quantities of
`urine within the conduit before it reaches the shut off
`portion of the valve.
`'
`The back portion of the housing adjacent the proxi-
`mal end of the slider unit has a frangible portion there-
`across. The frangible portion includes a boss which
`extends inwardly into the valve which frangible portion
`will break from the back side of the valve when the
`slider has been (pushed inwardly) advanced so as to
`permit fluid flow therethrough. The frangible portion
`comprises a tamper evident means for determining use
`of the large sampling or drain portion of the valve.
`A shrinkable tape may be disposed about the valve
`body to cover portions of the back of the valve housing
`so as to indicate tampering therewith when the valve
`has been opened, which could be used instead of or in
`addition to the frangible panel thereon.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`10
`
`15
`
`20
`
`25
`
`35
`
`The objects and advantages of the present invention
`will become more apparent when viewed in conjunc-
`tion with the following drawings, in which:
`FIG. 1 is a front elevational view of a urine bag as-
`sembly having a meter therewith and a valve attached
`to said meter;
`FIG. 2 is a side elevational view of the valve shown
`in FIG. 1; and
`FIG. 3 is a sectional view taken along the lines III-
`—-III of FIG. 2.
`—
`
`DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`60
`
`Referring now to the drawings in detail, and particu-
`larly to FIG. 1, there is shown a urine collection assem-
`bly 20, having a rigid front receptacle 22, a flexible rear
`container. or bag 24, a support arrangement 26, and inlet
`conduit means 28, similar to that shown in commonly
`assigned patent application Ser. Nos. 876,622 and
`919,276 both incorporated herein by reference. The
`receptacle 22 may be made of any suitable rigid plastic
`material which is transparent. The container 24 may
`have walls constructed of any suitable, flexible plastic
`material.
`
`ACTA EX. 1019-004
`
`ACTA Ex. 1019-004
`
`
`
`3
`The receptacle 22 has a front wall 30, a rear wall 32,
`a pair of sidewalls 34 and 36 at proposed sides of the
`receptacle 22, and a bottom wall 38 defining a cavity
`body in the receptacle 22. The receptacle 22 has a top
`42 defining an elongated opening. In use, urine is ini-
`tially directed into a small inner compartment 48 for
`more accurate volume measurement by indicia ar-
`ranged on the front wall 30. Urine is permitted to over-
`flow from the upper portion of the walls defining the
`inner compartment 48. The receptacle 22 has a pair of
`lower depending lift tabs 53 to facilitate movement of
`the receptacle 22 relative to the container 24, for drain-
`age of the contents of the receptacle 22 into the con-
`tainer 24.
`The receptacle 22 has a lower valve 52 communicat-
`ing with the inner compartment 48 through a conduit
`51, as shown in FIG. 2, in order to drain urine from the
`inner compartment 48 during use of the urine meter 20,
`to obtain either a large or a small fresh sample of urine.
`The valve 52 extending beneath receptacle 22 is of
`generally longitudinal shape, having a housing 54 com-
`prising a front half 56, and a rear half 58. The valve 52
`has an upper end with an opening 60 therein. The valve
`52 has a lower end 62 with an opening 64 therein. An
`adapter 66 mates in the opening 60 at the upper end of
`the valve 52. The adapter 66 is arranged to snugly fit
`into the configuration of the opening 60. The uppermost
`distal end of the adapter 66 has a circular opening 68
`theredisposed. The opening 68 in the distal end of the
`adapter 66 is in fluid communication with a bore 70
`which extends completely longitudinally through the
`adapter 66. The lower end of the adapter 66 is centrally
`disposed within the housing 54 of the valve 52. The
`distalmost end of the adapter 66 has a generally cylin-
`drically shaped configuration thereto, which mates
`with a flexible tubular conduit 71 which itself extends
`through the generally longitudinal center of the valve
`member 52. The flexible conduit 71 has an open end 72
`which is generally coincidental with the open end of the
`lower end 62 of the valve 52.
`The adapter 66 has a side portion 74 with an opening
`76 therein. The opening 76 permits communication
`H between the bore 70 of the adapter 66 from outside
`thereof.
`
`10
`
`15
`
`20
`
`25
`
`30
`
`A septum 78 made of a resilient plastic or rubber
`material mates over and covers the orifice 76 on the side
`74 of the adapter 66, is shown in FIG. 2. The septum 78
`is arranged so as to seal the opening 76 from any outside
`air or contamination and allows penetration by a needle
`or the like. An annular groove 80 around the side por-
`tion 74 on the adapter 66 receives a ridge 82 of the
`septum 78 to ensure the seal thereinbetween.
`A slide release or slider 84 extends through an open-
`ing 86 in the front panel 56. The slider 84 is arranged
`transversely across the longitudinal fluid flow path in
`the valve 52. The slider 84 has a pair of sidewalls 88,
`only one shown in FIG. 2 and a pair of transverse walls
`92 and 103 that extend between the sidewalls 88, which
`all define an opening 90 disposed therebetween. The
`flexible conduit or tube 71 is arranged to be disposed
`within the opening 90 in the slider 84. A pair of brackets
`93 and 95 are disposed above and beneath the slider 84,
`respectively. The brackets 93 and 95 extend only partly
`transversely across the body of the valve housings 56
`and 58. A nub 94 is arranged on the lower outside edge
`of the opening 86 on the front housing 56. A faceplate
`96 is disposed on the distalmost end of the slider 84. A
`spring 98 is disposed between the back side of the face
`
`4,728,324
`
`4
`plate 96 and the nub 94, so as to continuously bias the
`slider 84 outwardly from the valve 52. The flexible
`resilient conduit 71 is biased in the pinched closed con-
`dition by being pressed against the pair of brackets 93
`and 95 on the front half 56 of the housing 54, by the
`proximalmost wall 92 across the end of the slider 84.
`The back half 58 of the housing 54 may have a frangi-
`ble panel 100 adjacent the slider 84. The panel 100 may
`have a tab member 102 which extends inwardly
`towards the center of the valve 52 and near the proxi-
`mal most wall 103 of the slider 84.
`
`During use of the urine meter assembly 20, urine is
`first retained in the receptacle 22 for initial volume
`measurement thereof. Actual sampling of the urine for
`further testing will usually be necessary. As is most
`often the case, only small samples, say in the range of 2
`to 10 milliliters are needed. This may be done by insert-
`ing a needle with syringe through the septum 78 so as to
`retrieve the fresh urine which is collected within the
`bore 70 of the valve 52 at the bottom of the receptacle
`22. The needle may be merely inserted through the
`resealable septum 78 through the orifice 76 and the
`front portion 74 of the adapter 66 until it reaches the
`bore 70, whereupon the small sample may be taken. The
`path for this sampling is also shown in FIG. 3 wherein
`the septum 78 shows access to the orifice 76 and the
`bore 70 of the valve 52.
`When larger urine samples are required to be taken,
`such as for specific gravity tests of the urine, wherein 30
`to 40 milliliters of fresh urine may need to be removed,
`the slider 84 may be pressed inwardly against the bias-
`ing action of the spring 98 so as to open the flexible tube
`and unpinch it, thus permitting rapid drainage of the
`rigid receptacle 22. Unfortunately however, this action
`may permit the possibility of contamination of the re-
`ceptacle 22. It is important to utilize the slider 84 for
`taking urine samples as infrequently as possible. It is also
`very important to know that a large sample, has been
`taken when one actually has been done! Thus the valve
`indicating opening indicating means such as the frangi-
`ble panel on the back half of the housing 58 may be
`utilized to show that the slider 84 has been pressed
`inwardly so as to fracture the frangible panel 100 by
`pressing against the tab 102 thereof.
`A frangible panel would discourage the easy (or lazy)
`way of taking a small urine sample and make evident the
`use of such a procedure and indicate the possibility of
`contamination. The bag or collection system 20 could
`then be changed or other necessary actions undertaken.
`Other slider evident means for valve opening means
`may be arranged around the valve housing 54 as shown
`in dashed lines in FIG. 2, such as a heat shrinkable band
`or tape 110 which may be disposed about the periphery
`of the valve housing 54 and particularly about the back
`side of the back half of the housing 58. Thus if the slider
`84 were pushed inwardly to open (unpinch) the flexible
`tubing 71, the tamper evident seal or band 110 would be
`torn or otherwise disturbed by the back wall 92 of the
`slider 84, or something in the nature of a boss 105 on the
`backside to indicate that the valve had been opened for
`flow of urine samples therethrough.
`The need for fresh samples from both the small and
`large sample sources is significant because if the sample
`is mixed with older urine, important medical informa-
`tion regarding the ongoing and developing condition of
`the patient may be lost.
`Thus there has been shown a novel arrangement for
`permitting small fresh samples to be taken from a urine
`
`ACTA EX. 1019-005
`
`ACTA Ex. 1019-005
`
`
`
`4,728,324
`
`10
`
`. 5
`meter, while also permitting larger fresh urine samples
`to be taken as required before they are otherwise
`dumped into the main collection bag 24. The large sam-
`pler means, however, having utilization discouraging or
`tamper evident means therewith in order to inhibit med-
`ical personnel from taking the small samples from the
`large sampler means. The more frequently the large
`samples are taken, the more likely the possibility of
`contamination within the entire system.
`We claim:
`1. A multiple use valve assembly having means for
`permitting only small samples to be taken therefrom and
`further means for permitting larger samples therefrom,
`said valve comprising:
`a housing having a front portion and a rear portion,
`said housing having a generally longitudinal open-
`ing therethrough;
`an intake opening at one end of said housing and a
`large sample discharge opening at the other end of 20
`said housing;
`a scalable sampling port for taking small urine sam-
`ples from said housing, adjacent its intake opening;
`a biased release means in said housing adjacent its
`discharge opening for the discharge of large sam-
`ples of urine thereby;
`a tamper evident means associated with said housing
`and said biased release means to indicate any dis-
`charge of urine through said larger sample means
`by the use of said biased release means;
`an elongated adapter comprising the intake opening
`of said housing, said elongated adapter having a
`generally longitudinally directed bore
`there-
`through;
`said elongated adapter having said sampling port
`through a sidewall
`thereof, said sampling port
`being in fluid communication with said bore; and
`a flexible tube secured to the discharge end of said
`elongated adapter, said flexible tube extending
`through said biased release means and open at the
`discharge opening said housing;
`said tamper evident means comprising a frangible
`panel disposed in said rear portion of said housing,
`in alignment with said biasing means disposed
`through said front housing, wherein displacement
`of said biased means so as to undistort said flexible
`
`tube to permit the flow of urine therethrough, will
`fracture said frangible panel in said rear housing,
`thus indicating the large sampling means’ use.
`2. A multiple use valve as recited in claim 1, wherein
`said biased release means extends through an opening in
`the front portion of said housing, adjacent its large‘
`sample discharge opening, said biased release means
`having a spring which effectuates a constant pressure to
`close said flexible tube until said means is pressed from 55
`the outside.
`.
`3. A multiple use valve assembly as recited in claim 2,
`wherein said biased release means effectuates a distor-
`tion in said flexible tube by pinching said tube against
`the inside of said housing.
`
`6
`4. A multiple use valve assembly as recited in claim 2,
`wherein said tamper evident means comprises a tearable
`band disposed about said housing adjacent said biased
`release means, wherein displacement of said release
`means will effectuate tearing of said band to indicate use
`of said biasing means.
`5. A multiple use valve assembly as recited in claim 2,’
`wherein said sampling port comprises a septum which
`may be pierced by a sampling means, which septum
`reseals itself when said sampling means is withdrawn
`therefrom.
`
`6. A multiple use valve assembly as recited in claim 2,
`wherein said biased release means has a back wall which
`strikes the tamper evident means causing a disturbance
`thereof, thus indicating its use.
`7. A valve assembly for the release of large samples of
`urine from a urine meter on a urine collection bag, said
`valve assembly comprising:
`a urine collection bag;
`a housing having a front portion and a rear portion,
`said housing having a generally longitudinal chan-
`nel therethrough;
`an intake opening at one end of said housing and a
`large sample discharge opening of the other end of
`said housing, said housing being in fluid communi-
`cation with said urine meter on said urine collec-
`tion bag;
`a biased release means disposed on the front portion
`of said housing. adjacent its discharge opening to
`permit the discharge of large samples of fresh urine
`from said urine meter; and
`frangible tamper evident means arranged on said
`housing proximal to said biased release means to
`provide indication of use of said biased release
`means.
`-
`
`8. A valve assembly as recited in claim 7, wherein
`said biased release means has a bias means disposed on
`the front portion of said housing.
`9. A valve assembly as recited in claim 7, wherein
`said tamper evident means comprises a frangible panel
`disposed on said rear portion of said housing, which
`frangible panel is struck by said biased release means to
`indicate its use.
`10. A valve assembly as recited in claim 9, wherein
`said biased release means comprises a slider which is
`disposed into said housing, said slider having one end
`which is arranged to strike said frangible panel when
`said biased release means is utilized.
`11. A valve assembly as recited in claim 10, wherein
`said bias means comprises a spring disposed between the
`front of said housing and a portion of said slider.
`12. A valve assembly as recited in claim 10, including
`a further sampling means for permitting only small
`samples of urine to be taken therefrom.
`13. A valve assembly as recited in claim 7, wherein
`said tamper evident means comprises a disturbable band
`disposed about said housing adjacent said biased release
`means so as to indicate use thereof if said band is dis-
`turbed.
`
`8
`
`1
`
`#
`
`1|
`
`*
`
`ACTA Ex. 1019-066
`
`ACTA Ex. 1019-006
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