G2) INFERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT)
`(19) World Intellectual Property
`~
`Organization
`International Bureau
`
`CEE
`
`(43) International Publication Date
`4 May 2017 (64.05.2017)
`
`WIPO) POT
`
`AK
`
`(19) international Publication Number
`WO2017/074731 Al
`
`Designated States (unless otherwise indicated, for every
`Kind ofnational protection availiable}, AB, AG, AL, AM,
`AO, AT, AU, AZ, BA, BB, BG, BU, BN, BR, BW, BY,
`RBZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM,
`DO, DZ, EC, FE, EG, ES, FL, GB, GD, GE, GH, GM, GT,
`AN, HR, HU, 1D, OL, IN, IR, IS, IP, KE, KG, EN, KP, KR,
`KW, KA, LA, LO, LK, LR, LS, LU, LY, MA, MD, ME,
`MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ,
`OM, PA, PE, PG, PH, PL, PT, QA, KO, RS, RU, RW, SA,
`SC, SD, SF, SG, SK, SL, SM, ST, SV, SY, TH, TE TM,
`TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM,
`iW,
`
`8H
`
`International Patent Classification:
`ABLM 39/00 (2006.01)
`AGIM 39/22 (2006.01)
`ABIM 39/16 (2006.61)
`
`ish
`
`ay
`
`international Application Number:
`
`PCT/US261 6/057348
`
`a2
`
`International Filing Date:
`
`17 October 2016 17.16.2016)
`
`Qs)
`
`26)
`
`30)
`
`7D
`
`(72)
`
`Filine Language:
`
`Publication Language:
`
`English
`
`English
`
`Priority Data:
`62/248,505
`
`30 October 2015 6,10.2015)}
`
`US
`
`Applicant: C.K. BARB, INC. [US/OS]: 730 Central Av-
`enue, Murray Hill, New Jersey 07974 CUS).
`
`inventors: GLITHERO, Jason fain; 604 Broken Arrow
`Cove, McDonough, Georgia 30252 CUS). SWHENEY,
`Lyadsay Alison; 5205 Grayson Place, Decatur, Georgia
`30030 CUS). PRIVITERA, Salvatore, 6403 Edgebrook
`Court, Mason, Ohio 45040 CUS),
`
`(74)
`
`Agents: SIMON, Marcus §$. et al; Dorsey & Whitney
`LLP, 136 S. Main Street, Suile 1000, Salt Lake City, Utah
`34101 (US).
`
`(84)
`
`Pesigmated States (unless otherwise indicated, for every
`kind ofregional protection available}; ARIPO (BW, GH,
`GM, KE, LR, LS, MW, MZ, NA, BW, 5D, SL, ST, SZ,
`TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU,
`TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE,
`DK, EE, ES, FL FR, GB, GR, HR, AU, TE, 1S, IT, LP, LU,
`LV, MC, ME, MT, NEL, NO, PL, PT, RO, RS, SE, SL SK,
`SM, TR), OAPI (BP, BI, CP, CG, CL CM, GA, GN, GQ,
`GW, EM, ML, MR, NE, 5N, TD, TG).
`Published:
`
`with international search report (Art. 213)
`
`(54) Title: VENT ADAPTOR ASSEMBLIES, METHODS OF MAKING THE SAME, METHODS OF USING THE SAME, AND
`URINARY DRAINAGEBAG SYSTEMS USING TILE SAME
`
`directed to vent adaptor assemblies inchiding a
`vent adaptor, methods of making such vent ad-
`aptor assemblies, method of using such vent ad-
`aptor assemblies, and urinary drainage bag sys-
`tems including such vent adaptor assemblies. in
`an embodiment, a vert adaptor assembly includes
`a filter that is configured to permit gas (e.g., ait)
`to flowtherethrough, while simultaneously at least
`partially preventing fhud present within the vent
`adaptor assembly fe.g..
`urine)
`from flowing
`therethrough.
`
` G7) Abstract: Embodiments disclosed herein are
`
`
`
`
`
`wo2017074731At(HT
`
`

`

`WO 201 7/074731
`
`PCT/US82016/037348
`
`H
`
`iD
`
`VENT ADAPTOR ASSEMBLIES,METHODS OF MAKING THE SAME,
`METHODS OF USING THE SAME, AND URINARY DRAINAGE BAG
`SYSTEMS USING THE SAME
`
`CROSS-REFERENCE TO RELATED APPLICATIONS
`
`[0001]
`
`This
`
`application claims priority to U.S. Provisional Application No.
`
`62/248,505 filed on October 30, 2015, the disclosure of which is incorporated herein, in
`
`its entirety, by the reference.
`
`BACKGROURD
`
`[0002]
`
`Typically, unnary catheterization involves insertion of a urinary catheter (e.g.
`
`tube) through a patient’s urethra and into the patient’s bladder. Conventional drainage
`
`systems
`
`for urmary catheterization include a urinary catheter @¢., a Foley urmary
`
`catheter} coupled to a drainage bag using a drainage tube. As such, the urinary catheter
`
`allows the patient’s urmeto dramfromthe bladder through the draimage tube and into the
`
`drainage bag.
`
`(8803;
`
`However, conventional drainage systerns using urinary catheters may exhibit a
`
`number of fluid flow problerns. For example, vapor lock, bends, or kinks in a drainage
`
`tube canrestrict (¢.¢., prevent) the flow of anne from the urinary catheter to the drainage
`
`bag. Limiting the flow of unne may increase the patient’s chances of developing a
`
`catheter-associated urinary tract
`
`imfection (CAUTT), create a backpressure that
`
`increases patient discomfort (e.g, increase patient’s urge to void bladder}, and prevent
`
`accurate determination of urine output. Additionally, negative pressures may be created
`
`while using the drainage system (¢.g., when rapidly draimmg urine from a bend in the
`
`drainage tube). Such negative pressures may inadvertently create a suction event within
`
`the bladder that may cause bladder mucosa of the bladder to be partially suctioned mto
`
`the urinary catheter. Such suction events may darnage the bladder mucosa which,intum,
`
`may increase the patient’s chances of developing a CAUTI. Tvpicaily, vents are coupled
`
`to a component ofthe dramage system to alleviate these drainage problems.
`
`[0004]
`
`However, the vents may adversely affect the functionality of the drainage
`
`system. For example, conventional drainage system may be used to measure the intra-
`
`abdominal pressure of the patient.
`
`Typically, the intra-abdominal pressure is measured bv
`
`clampmg ibe drainage tube closed, filling the bladder with a solution(e.2., 0.9%sodiam
`
`chloride solution) using a sample port. and measuring the mean pressure within the
`
`drainage tube. However, vents coupled to the drainage system may prevent accurate
`
`intra-abdominal pressure measurements.
`
`- Page I -
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`SUBSTIPUTE SHEET (RULE 26)
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`WO 2617/074731
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`[0005]
`Accordingly, manufacturers and users of urimary dramage bag systems, such
`
`as catheterization systems, continue to seek improvements thereto.
`
`SUMMARY
`
`(0606)
`
`Embodiments disclosed herem are directed to vent adaptor assemblies
`
`5
`
` meluding a filter, methods of making such vent adaptor assemblies, methods of using
`
`such vent adaptor assemblies, and urimary drainage bag systems including such vent
`
`adaptor assemblies. The vent adaptor assemblies disclosed herein include a filter that is
`
`configured to permit gas (e.g, air) to flow therethrough, while simultaneously at least
`
`partiaily preventing fluid present within the drainage bag system (e.g, umne} from
`
`ig
`
`Howing therethrough.
`
`(0007)
`
`In an embodiment, a vent adaptor assembly is disclosed. The vent adaptor
`
`assembly inchides a dramage body defining a vent opening, a proximal opening, a distal
`
`opening spaced fromthe proximal opening, and a draimage lumen extending between the
`
`proximal and distal operungs. The dramage lumen is m fhud communication with the
`
`15
`
`vent opening
`
`The vent
`
`adaptor
`
`assembly
`
`also includes
`
`a
`
`sintered porous
`
`polvtetrafluoroethylene (“PTFE”) filter disposed in fluid corarounication with the vent
`
`opening of the drainage body. The sintered porous PTFE fitter defines a plurality of
`
`pores therein. The sintered porous PTFE filter is directly welded to a component of the
`
`vent adaptor assembly. The component is formed at least partially from polycarbonate.
`
`boa
`
`At least some of the plurality of pores of the sintered porous PTFE filter are occupied by
`
`the polycarbonate ofthe component ofthe vent adaptor.
`
`j0008{
`
`In an embodiment, a vent adaptor assembly is disclosed. The vent adaptor
`
`assembly includes a dramage body defining a proximal opening, a distal opening, and a
`
`drainage fumen extending between the proximal and distal openings. The drainage body
`
`25
`
`further at least partially defines a vent opening in fluid communication with the drainage
`
`lumen. The vent adaptor assembly also mcludes a filter in fluid communication with ihe
`
`vent opening of the drainage bodv. The vent adaptor assembly further includes a flow
`
`regulator. The flow regulator includes a flow barrier positioned at least partially within
`
`the drainage himen of the drainage body. The flow regulator also includes an actuaior
`
`30
`
`operably coupled to the flow barner. The actuator is configured to move the flow barner
`
`between @ first position and a second position. The flow barrier permits fd to flow
`
`through the dramage himen to the distal opening when the flow barrter ts in the first
`
`position and substantially prevents the fluid to flow through the drainage lumen to the
`
`disial opening when the barrier is in the second position.
`
`- Page 2 -
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`WO 2017/074731
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`(6009;
`In an embodiment, a urinary drainage bag systemis disclosed. The urinary
`
`drainage bag system includes a drainage bag having an inlet and configured to store at
`
`least one fluid therein.
`
`The urinary drainage bag system also includes a catheter.
`
`Additionally, the armary drainage bag system imcludes at least one dramage tube fhuadly
`
`5
`
`coupling the inlet of the drainage bag to the catheter. The urinary drainage bag system
`
`further includes a vent adaptor coupled ihe at
`
`least one drainage tube between the
`
`drainage bag and the catheter. The vent adaptor assembly includes a dramage body
`
`defining a proximal opening, a distal opening, and a drainage lumen extending between
`
`the proximal and distal openings. The drainage body further at least partially defines a
`
`id
`
`vent opening in fluid communication with the drainage lumen.
`
`The vent adaptor
`
`assembly also includes a filter in fluid communication with the vent opening of the
`
`drainage body. The filter includes a material that is at least substantially impermeable to
`
`a liquid and at least partially permeable to a gas. The vent adaptor includes a device that
`
`includes a cap configured to cover at least a portion of the vent opening or a flow
`
`15
`
`regulator configured to regulate fluid flow through the drainage lumen the device. The
`
`device is configured to selectively switch between a first position and a second position.
`
`The device permits a flow of ihe gas through the filter into at least the entire dramage
`
`lumen when in the first position and restricts the flowof the gas through the filter into at
`
`least a portion of the drainage lumen when in the second position.
`
`20,
`
`{0020}
`
`In an embodiment, a method of ultrasonically welding a sintered porous PTFE
`
`filter to a component of a vent adaptor assembly is disclosed. The method includes
`
`posttioning the sintered porous PTFE filter adjacent to the component of the vent adapior
`
`assembly. The sintered porous PTFE filter defining a plurality of pores therein and the
`
`component of the vent adaptor assemblyat least partially formed of polvcarbonate. The
`
`25.
`
`method also inchides ultrasonically welding the sintered porous PTFE filter to the
`
`component of the vent adaptor assembly such that at feast some of the polycarbonate of
`
`the component of the vent adaptor assermbly softens and flows into and at least partially
`
`occupies some ofthe plurality of pores ofthe sintered porous PTFE filter.
`
`(0041;
`
`In an embodiment, a method of using drainage bag systern that includes a vent
`
`30=adaptor is disclosed. The method includes flowing a liquid through a drainage lumen
`
`defined by a drainage body of the vent adaptor. The method also inchides flowing a gas
`
`through a vent opening that is at least partially defined by the dramnage body, through a
`
`filter that is in flhid communication with the vent openmng of the drainage bedv. and inte
`
`al least an entirety of the drainage lumen of the drainage body. The method further
`
`- Page 3 -
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`SUBSTITUTE SHEET (RULE 26}
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`WO 2017/074731
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`includes, after flowing the gas through the vent opening, through the filter, and into at
`
`least an errtirety of the drainage lumen: restricting the flow of the gas into at least a
`
`portion of the drainage lumen using a cap that is configured to at least partially cover the
`
`vent opening or a flow regulator that is configured to regulate flund flowthrough ihe
`
`drainage lumen.
`
`[0812]
`
`Features from any ofthe disclosed embodiments may be used in combination
`
`with one another, without limitation.
`
`In addition, other features and advantages of the
`
`present disclosure will become apparent to those of ordinary skill
`
`in the art through
`
`consideration of the following detailed description and the accompanying drawings.
`
`10
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`(0023]
`
`The drawings ifustrate several embodiments of the present disclosure,
`
`wherem identical reference numerals refer to identical or similar elements or features in
`
`different views or embodiments shownin the drawings.
`
`{014}
`
`FIG. 1 is a top plan viewof a urinary drainage bag system including a vent
`
`adaptor assembly, accordmg to an embodiment,
`
`[6045]
`
`FIG. 2A is an exploded isometric viewof a vent adaptor assembly including
`
`a vent, according to an embodiment,
`
`[0616]
`
`FIG, 2B is an assembled cross-sectional view of the vent adaptor assembly
`
`taken along line 2B-2B thereof.
`
`boa
`
`[0017]
`
`FIG, 3 is a Bow diagram of a method of manufacturing the vent adaptor
`
`asserobly shown in FIGS, 24-26. according to an embodiment.
`
`{0078}
`
`FIG, 4A 1s an exploded isometric view of a vent adaptor assembly including
`
`a filter and a sampling port, according to an embodiment.
`
`(68 19}
`
`PEG. 4B is an assembled cross-sectional view of the vent adaptor assembly
`
`shown in FIG. 4A taken along line 4B-4B thereof,
`
`(0620)
`
`FIG, 5A is an exploded isometric viewof a vent adaptor assembly including
`
`a vent adaptor and a sampling port adaptor, according tc an embodiment.
`
`[6021]
`
`FIGS. SB and 5C are isometric cutaway views of the assembled vent
`
`adaptor assembly shown in FRG, SA illustrating a flowbarrier thereof in first and second
`
`30
`
`positions, according to an embodiment.
`
`
`
`{0022} FHG. 6 is an isometric cutaway viewofavent adaptor assembly including a
`
`vent and a flowregulator, accordmeg to an embodiment.
`
`[0023]
`
`FIG. 7 is an isometric view of a vent adaptor assembly inchidine a vent, a
`
`flowregulator, and a sampling port, according to an embodiment.
`
`- Page 4 -
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`SUBSTIPUTE SHEET (RULE 26}
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`WO 2617/074731
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`PCT/US2016/037348
`
`DETAILED DESCRIPTION
`
`{0024}
`
`Embodiments disclosed herein are directed to vent adaptor assemblies
`
`inchiding a filter, methods of making such vent adaptor assemblies, methods of using
`
`such vent adaptor assemblies, and urinary drainage bag systems includmg such vent
`
`
`
`5 adaptor assembles. The vent adaptor assemblies disclosed herein includeafilter that is
`
`configured to permit gas (e.g., air) to flow therethrough, while simultaneously at least
`
`partially preventing fluid present within the vent adaptor assembly {e.¢., urine) from
`
`flowing therethrough.
`
`In an embediment, the filter includes a sintered porous PTFEfilter,
`
`which may be m the form of a film that
`
`is ultrasonicallv directly welded to a
`
`ig
`
`polycarbonate component (¢.2, non-porous polycarbonate component) of the vent
`
`adaptor assembly.
`
`{0025}
`
`While many of the embodiments disclosed herein discuss the vent adaptor
`
`assemblies in relation to a urinary drainage bag system {e.g., a Folev catheterization
`
`system), 1 should be understood that the vent adaptor assemblies disclosed herem may be
`
`15
`
`used in other types of dramage systems.
`
`For example, the vent adaptor assemblies
`
`disclosed herem may be used in a blood collection systemor in other types of fluid
`
`drainage bag systems.
`
`[0026]
`
` FEG. 1 is a top plan view of a urinary drainage bag system 100 including a
`
`vent adaptor assembly 102, according to an embodiment. The urmary drainage bag
`
`boa
`
`system 100 ulustrates one environment in which the vent adaptor assemblies disclosed
`
`herein may be employed.
`
`[t should be noted that any of the vent adaptor assemblies
`
`disclosed herein raay be meorporated in the urinary drainage bag system 100 or other
`
`suitable urmary drainage bag systems.
`
`(6027;
`
`The umnary drainage bag system 100 imeludes a drainage bag 104 that is
`
`25
`
`fluidfy coupled to a catheter 106 (e.g., urinary catheter) via a drainage tube 108. When
`
`the catheter 106 is mserted into a bladder of a patient, a fhad (e.g, urine) may flowfrom
`
`andthrough the catheter 106 into the drainage bag 104. The vent adaptor assembly 102
`
`may be physically and fluidly coupled io one or more components of the urinary drainage
`
`bag system 100 to improve fluid flow benween the catheter 106 and the drainage bag 104,
`
`30
`
`-For example, the vent adaptor assembly 102 mcludes a vent 110 that permits ar to enter
`
`the urinary drainage bag system 100, while partially or substantially preventing fluid
`
`(v.2., urine) fromexiting the urinary dramage bag system 100 through the vent 110. The
`
`vent 110 also helps maintain atmospheric pressure within the urinary drainage bae system
`
`100 at least al and/or near the vent 110. For example, the vent 110 may help mamiain
`
`- Page 5 -
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`SUBSTITUTE SHEET (RULE 26}
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`WO 2017/074731
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`atroospheric pressure through substantially all of the drainage tube 108 and/or the urimary
`
`drainage bag systern 100.
`
`(0828)
`
`In the ilustrated embodiment, the drainage bag 104 includes a front panel
`
`112 and a back panel bonded together to form a fhud tight container. However, in other
`
`embodiments, the drainage bag 104 ray include and/or may be formed by three or more
`
`panels, or a single body. Moreover,
`
`it should be appreciated that the panels of the
`
`drainage bag 104 may include flexible, ngid,
`
`resilient, any suitable material, or
`
`combinations of materials.
`
`In any event, the panels of the drainage bag 104 may be
`
`connected and/or bonded together in a manner that forms or defines an mterior space of
`
`10
`
`the drainage bag 104, which may contain fluid therein. Generally, the drainage bag 104
`
`may have any suilable geometry.
`
`fn the illustrated embodiment. the drainage bag 104 has
`
`a generally tear-shaped geometry. However, in other embodiments, the drainage bag 104
`
`may have a generally circular geometry, a generally rectangular geometry, or other
`
`suilable geometry.
`
`[6029]
`
`The drainage bag 104 also includes an inlet 114, which may be configured to
`
`accept fluid from the patient into the drainage bag 104. For example, the inlet 114 may
`
`receive or connect to the dramage tube 108 that may be m fluid communication with ihe
`
`catheter 106 positioned in the pattent’s bladder.
`
`in the uhistrated embodiment.
`
`the
`
`catheter 106 may include a Foley urinary catheter, such that urine may flow inte the
`
`boa
`
`drainage bag 104 fromthe catheter 106.
`
`(0030;
`
`In an embodiment, the dramage bag 104 mayinclude an outlet 116 fe... at or
`
`neat abottom of the dramnage bag 104). For example, the outlet 116 may be configured to
`
`allowfluid collected in the dramage bag 104 to flow or drain from the dramage bag 104
`
`(e.g., for collecting or extracting the fluid fromthe dramnage bag 104). For example, the
`
`outlet 116 may include the Safety-Flow™outlet device or another simular outlet device.
`
`[0031]
`
`The front panel 112 of the drainage bag 104 may further mclude one
`
`or more
`
`graduated markings 118 that may indicate an arnount of fluid collected in the drainage
`
`bag 104.
`
`For example,
`
`the graduated markings 118 mayfacilitate determining the
`
`amount of fluid discharged by the patient in a selected time span.
`
`In some embodiments,
`
`30
`
`the graduated markmg 118 may facilitate one or more determining or approximating time
`
`and/or date for draining, removing, or changing out the drainage bag 104. Flowproblems
`
`within the drainage bag system 100 may prevent accurate measurement of the fluid using
`
`the eraduated markings 118.
`
`- Page 6 -
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`WO 2017/074731
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`[6032]
`The drainage tube 108 may define a himentherethrough that extends fromthe
`
`catheter 106 to the drainage bag 104. At least a portion of the drainage tube 108 may be
`
`sufficiently flexible to allowa clamp to at least partially collapse the dramage tube 108
`
`such that fluid cannot pass through the collapsed portion of the dramage tube 108.
`
`5
`
`Collapsing the drainage tube 108 may enable one or more tests to be performed, such as
`
`an intra-abdominal pressure measurement.
`
`[6033]
`
`In some embodiments, the drainage tube 108 mayinclude a first portion 1084
`
`and a second portion 08>. The first portion 108a may extend downstreamfromthe vent
`
`adaptor assembly 102 at least partially towards the dramage bag 104. The second portion
`
`i0
`
`1086 may extend upstream from the vent adaptor assembly 102 at least partially towards
`
`the catheter 106. The drainage tube 108 may also include one or more additional
`
`portions, such as a third portion 108c. Alternatively, the vent adapior assembly 102 may
`
`be integrally formed with the drainage tube 108.
`
`[0834]
`
`In some embodiments,
`
`the urinary drarmage bag system 100 may further
`
`15
`
`include a sarnpling port 120. The sampling port 120 may he configured to permtt a user
`
`{e.g., a physician, a nurse, or a medical technician) to take a sample of fluid present
`
`within the drainage tube 10% in an at least substantially sterile and fhud tight manner. For
`
`example, the sampling port 120 may permit the user to take samples ofthe fluid using a
`
`syringe device, such as a catheter tip syringe or a syringe with needles.
`
`In operation, a tip
`
`boa
`
`(e.2., needle or catheter tip) of the syringe device may be inserted through the sampling
`
`port 120 such that the trp is in fhuid communication with the fluid in the dramage tubs
`
`108. The sarapling port 120 may reseal
`
`itself in an at least substantially flad tight
`
`anner after the user takes ihe sample and removes the tip of the syringe device from the
`
`sampling port 120.
`
`In some embodiments, the sampling port 120 may be configured to
`
`25.
`
`permut the user io take multiple samples of the fluid from the drainage container.
`
`In some
`
`embodiments, the sampling port 120 may be configured to permit the user to iyect a flad
`
`mite the drainage tube 108 (e.g, up into the bladder), such as during an intra-abdominal
`
`pressure measurement.
`
`(6035,
`
`The sampling port 120 may be coupled to any component of the drainage bag
`
`30
`
`system 100.
`
`For example,
`
`in the illustrated embodiment,
`
`the sampling port 120 is
`
`coupled ic the second portion 108b cf the dramage tube 108 such that the sampling port
`
`120 18 proximate to and upstream from the vent adaptor assembly 102.
`
`In such an
`
`embodiment, the second portion [08b may have a leneth sufficient to be collapsed by a
`
`clamp. The sampling port 120 may also be coupled {o the third portion 1O8c of ihe
`
`- Page 7 -
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`drainage tube 108 such that the sampling port 120 is fluidly coupledto the catheter 106.
`
`Alternatively, the sampling port 120 may be coupled to a portion of the drainage tube 108
`
`(¢.g., the first portion 108a) ihat is downsirearn from the vent adaptor assembly 102.
`
`In
`
`some embodiments, the sampling port 120 may be omitted.
`
`5
`
`{0036}
`
`FIGS. 2A and 2B are exploded isometric and assembled cross-sectional
`
`views, respectively, of a vent adaptor assembly 202 inchiding a vent 210, accordimg to an
`
`embodiment. The vent adaptor assembly 202 includes a drainage body 222 that includes
`
`a proximal portion 224 having a proximal opening 236, a distal portion 226 that is
`
`positioned downstream from the proximal portion 224 and having a distal opening 238,
`
`i0
`
`and an intermediate portion 240 that extends between the proximal portion 224 and the
`
`distal portion 226. The proximal portion 224 and the distal portion 226 are each
`
`configured io physically and/or fludly couple the vent adaptor assembly 202 to a
`
`drainage tube (e.g¢., the drainage tube 108 shown FRG. 4).
`
`(0037)
`
`in the ilustrated embodiment, the proximal portion 224 of the dramage body
`
`15
`
`222 may be configured as a female connector that is configured to mate with a dranage
`
`tube (e.¢., the drainage tube 108 shown FIG. 1). For example, an inner diameterof the
`
`proximal portion 224 al the proximal opening 236 may be sized to receive the dramage
`
`tube therein,
`
`in the illustrated embodiment, the distal portion 226 of the drainage body
`
`222 may be configured as a male connector that is configured to mate with the drainage
`
`boa
`
`tube (e.g., the drainage tube 108 shown FIG. 1). For example, the outer diameter of the
`
`distal portion 226 at the distal opening 238 may be less than an toner diameter of the
`
`drainage tube.
`
`in an embodiment,
`
`the outer diameter of the distal portion 226 may be
`
`tapered and increase from the distal opening 238 towards the proximal partion 224 such
`
`that the outermost diameter of ihe distal portion 226, at a distance fromthe distal opening
`
`25
`
`238, is greater than ihe inner diameter of the drainage tube.
`
`In other embodiments, ihe
`
`proximal portion 224 may be configured as a male connector and/or the distal portion 226
`
`may be configured as a female connector.
`
`[6038]
`
`The drainage body 222 further defines a drainage lumen 225 extending
`
`through the intermediate portion 240,
`
`the proximal portion 224, and the disial portion
`
`30-226. The drainage iumen 225 is m fluid communication with the proximal openmg 236
`
`and the distal opening 238 so that fluid can flow through the proximal openme 236,
`
`through the dramage lumen 225, and out of the distal opening 238.
`
`In the illustrated
`
`embodiment, the intermediate portion 240 may exhibit a substantially evlindrical shape.
`
`However, the intermediate portion 240 may exhibit any suitable shape.
`
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`WO 2617/074731
`PCT/US2016/037348
`[0039]
`The dramage body 222 also at least partially defines a vent opening 228 that is
`
`in fluid communication with the drainage lumen 225.
`
`In the ubustrated embodiment, ihe
`
`vent opening 228 is at least partially defined by and located in the intermediate portion
`
`240 of the drainage body 222. However, in other embodiments, the vent openme 228
`
`5
`
`maybe located mm the proximal portion 224or the distal portion 226.
`
`(0040)
`
`nthe lustrated embodiment, ihe dramage body 222 includes a vent wall 242
`
`that at feast partially defines the vent opening 228. For example, the vent wall 242
`
`exhibits a generally cylindrical shape that extends outwardlyfrom the drainage body 222,
`
`such as extending outwardly from the intermediate portion 240of the drainage body 222.
`
`i0
`
`However,
`
`the vent wall 242 may exhibit any suitable shape, such as a generally
`
`rectangular shape, a generally oval shape, or any other suitable shape.
`
`In an embodiment,
`
`the vent wall 242 may be omitted such that the filter 232 and/or the retention member 230)
`
`may be directly coupled to the intermediate portion 240 or other portion of the drainage
`
`body 222.
`
`15
`
`[6047]
`
`In an embodiment,
`
`the vent wall 242 may be integrally formed with the
`
`drainage body 222. In other embodiments, the vent wall 242 may be distinct and separate
`
`from the dramage body 222 and atlached thereto using any suilable aitachment method.
`
`For example, the vent wall 242 may be attached to the drainage body 222 by ultrasonic
`
`welding, an adhesive, a threaded connection, another suitable techmique, or combinations
`
`boa
`
`thereof.
`
`[0042]
`
`The vent wall 242 may include a first mer region 244 that exhibits a first
`
`toner diameter and a second inner region 246 that exhibits a second inner diameter that is
`
`less than the first inner diameter. The second mner region 246 maybe located closer to
`
`the dratnage limen 225 than the first inner region 244. The decreased mner diameter of
`
`25
`
`the second inner region 246 of the vent wall 242 provides a flange surface that supports,
`
`1s attached to, and/or restricts movement of one or more components ofthe vent 210 (e.e.,
`
`the filter 232, the retention member 230, etc.) to which the filter 232 may be attached
`
`and/or prevent the retention member 230.
`
`In an embodiment, the second inner region 246
`
`of the vent wall 242 may be omitted such thai
`
`the vent opening 228 exhibus a
`
`30
`
`substantially uniform diameter.
`
`(0043;
`
`The drainage body 222 may be formed from one or more different materials.
`
`For example, one or more components of the drainage body 222 (e.g,
`
`the proximal
`
`portion 224, the distal portion 226, the vent wall 242, or a component of the vent 210)
`
`may include one or more of a polymeric material, a metallic material, a ceranuc, a
`
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`WO 2617/074731
`composite, or another suttable material.
`
`PCT/US2016/037348
`In particular, the drainage body 222 may beat
`
`least partially formed from at least one of poly carbonate(e.g, non-porous polycarbonate},
`
`polvviny! chloride (PVC, PTFE (¢.2, sintered PTFE},
`
`low density polyethylene
`
`CLDPE”),
`
`high
`
`density
`
`polyethylene
`
`(HDPE?)
`
`polypropylene,
`
`polystyrene,
`
`5
`
`polvchlorotrifluorcethylene (-PCTFE™), aluminum, stainless steel, or any other suitable
`
`material.
`
`[6044]
`
`The vent 210 includes at least one of a filter 232, a retention member 230, or a
`
`cap 234. The filter 232 is coupled to at least one of a portion of the drainage bodv 222
`
`that defines the vent opening 228 or a portion of the vent 210 such as a retention member
`
`i0
`
`230. The filter 232 is formed from a material that is configured ic be at least partially
`
`permeable to eas (e.g, air}, while being partially or substantially impermeable to a Hquid
`
`{e.g., urine}. The vent 210 is configured to at least substantially prevent liquid that is
`
`present within the drainage body 222 from exiting the through the vent opening 228. The
`
`vent 210 may further mchide a cap 234 configured to be removably attached to at least
`
`15
`
`one of the dramage body 222 or the vent 210. The cap 234 exhibits a size and shape
`
`configured to cover the vent opening 228, thereby restricting gas from flowing into and
`
`out of the drainage lumen 225 through the vent opening 228 whenthe cap 234 is attached.
`
`[0045]
`
`The filter 232 is formed and structured from a material that is substantially
`
`impermeable to a selected liguid (e.g., urine, water), while being at
`
`least partially
`
`boa
`
`permeable (¢.g., substantially permeable} to gas (¢.2., air), For example, the filler 232
`
`may include a porous polymer film that defines a plurality of pores therein. The porous
`
`polymer film may be at least partially formed from PTFE, silicons, another hydrophobic
`
`material, or combinations thereof. For example, im an embodiment, the porous polymer
`
`film that is formed partially or substantially completed from a smmtered porous PTFE film
`
`25.
`
`may be manefactured bysintering PTFE particles together to form the sintered film. The
`
`perous polymer film may be supported by (@.u., attached to) a perous substrate or ihe
`
`porous polymer film may be unsupported.
`
`In an embodiment, the substrate may facihtate
`
`attachment of the porous polymer film to at least one of the portion of the drainage body
`
`222 that partially defines the vent opening 228 or a portion of the vent 210 (¢.2., the vent
`
`30=wall 242 or the retention member 230).
`
`(0046;
`
`The filter 232 may be attached to at least one of the portion of the dramage
`
`body 222 that defines the vent opening 228 or a portion of the vent 210 in any suitable
`
`manner.
`
`In an embodiment, the filter 232 may be positioned between the retention
`
`member 230 and the second inner region 246 of the vent wall 242, while the retention
`
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`

`WO 2017/074731
`
`PCT/US26016/657348
`
`member 230 1s attached to the vent wall 242. As such. the retention member 230 andthe
`
`second inner region 246 of the vent wall 242 prevent movement of the filter 232 and
`
`effectively secure the filter 232 within the vent opening 228 to the dramnage body 222.
`
`In
`
`another embodiment, as will be discussed in more detail below with respect to FIG. 3, the
`
`filter 232 may be welded (¢.z., ultrasonically welded) io at least one the portion of ihe
`
`drainage body 222 that partially defines the vent opening 228 or a componentofthe vent
`
`210 such as the retention member 230,
`
`In another embodiment, the filter 232 may be
`
`attached to at least one of the portion of the drainage body 222 that defines the vent
`
`opering 228 or a component of the vent 210 using an adhesive, a mechanical fastener,
`
`10
`
`another suitable technique, or combinations thereof,
`
`[0047]
`
`The reiention member 230 may be configured to al least substantially cover
`
`the vent opening 228. For exanrple, a portion of the retention member 230 may exhibit a
`
`shape and size that allows the portion of the retention member 230 to be postiioned in the
`
`vent openmg 228. The retention member 230 may be formed from anv of materials
`
`disclosed herein for the drainage body 222.
`
`In an embodunent, the retention member 230
`
`exhibits an at least two two-tiered structure including a top portion 248 and a bottom
`
`portion 250. The top portion 248 exhibiis a generally disc-like geometry and exhibits a
`
`maximum diarneter that ts greater than the inner diameter ofthe first inner region 244 of
`
`the vent wall 242. The bottom portion 250 exhibits a shape