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WO2025136399A1 - Fluid collection devices including a fluid impermeable film and flat fluid permeable material disposed therein, and related systems and methods - Google Patents

Fluid collection devices including a fluid impermeable film and flat fluid permeable material disposed therein, and related systems and methods Download PDF

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Publication number
WO2025136399A1
WO2025136399A1 PCT/US2023/085516 US2023085516W WO2025136399A1 WO 2025136399 A1 WO2025136399 A1 WO 2025136399A1 US 2023085516 W US2023085516 W US 2023085516W WO 2025136399 A1 WO2025136399 A1 WO 2025136399A1
Authority
WO
WIPO (PCT)
Prior art keywords
fluid
panel
conduit
collection device
permeable material
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2023/085516
Other languages
French (fr)
Inventor
Arwen BROUGHTON
Melody Mei Hee KURODA
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PureWick Corp
Original Assignee
PureWick Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by PureWick Corp filed Critical PureWick Corp
Priority to PCT/US2023/085516 priority Critical patent/WO2025136399A1/en
Publication of WO2025136399A1 publication Critical patent/WO2025136399A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/451Genital or anal receptacles
    • A61F5/455Genital or anal receptacles for collecting urine or discharge from female member
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices ; Anti-rape devices
    • A61F5/44Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices
    • A61F5/4401Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Colostomy devices with absorbent pads

Definitions

  • FLUID COLLECTION DEVICES INCLUDING A FLUID IMPERMEABLE FILM AND FLAT FLUID PERMEABLE MATERIAL DISPOSED THEREIN, AND RELATED SYSTEMS AND METHODS
  • An individual may have limited or impaired mobility such that typical urination processes are challenging or impossible.
  • the individual may have surgery or a disability that impairs mobility.
  • the individual may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from the individual may be needed for monitoring purposes or clinical testing.
  • Bed pans and urinary catheters such as a Foley catheter, can be used to address some of these circumstances.
  • bed pans and urinary catheters have several problems associated therewith.
  • bed pans can be prone to discomfort, pressure ulcers spills, and other hygiene issues.
  • Urinary catheters be can be uncomfortable, painful, and can cause urinary' tract infections.
  • Embodiments disclosed herein include fluid collection devices, and related assemblies, systems, and methods of manufacture.
  • a fluid collection device includes a fluid impermeable film including a distal region, a proximal region, a first panel positioned at least partially between the distal region and the proximal region and having a first proximal end, and a second panel positioned at least partially between the distal region and the proximal region and having a second proximal end spaced proximally from the first proximal end of the first panel.
  • the first panel and the second panel at least partially define a chamber therebetween and an opening in fluid communication with the chamber.
  • the fluid collection device includes a fluid permeable material positioned within the chamber and configured to space the first panel from the second panel and retain the opening between the first panel and the second panel.
  • the fluid collection device includes one or more porous materials extending between the proximal region and the distal region. A first portion of the one or more porous materials is secured to the first panel opposite to the second panel and extends distally from at least proximate to the first proximal end of the first panel. A second portion of the one or more porous materials extends proximally from at least proximate to the first proximal end of the first panel and is secured to the second panel such that the second portion extends from the first panel to the second panel over the opening.
  • the fluid collection device includes a conduit having an inlet positioned in the chamber and extending proximally from the fluid collection device.
  • a fluid collection device in an embodiment, includes a fluid impermeable barrier defining a chamber and an opening in fluid communication with the chamber.
  • the fluid collection device includes a fluid permeable material positioned within the chamber and configured to space apart the fluid impermeable barrier and retain the opening in the fluid impermeable barrier, the fluid permeable material including a hydrophobic material.
  • the fluid collection device includes a conduit having an inlet positioned in the chamber and extend outward from the fluid impermeable barrier.
  • the conduit includes an additional fluid permeable material positioned within the conduit having a hydrophilic region extending outward from the inlet into the chamber and a hydrophobic region positioned within the conduit.
  • a method of manufacturing a fluid collection device includes securing a first panel of fluid impermeable film to a second panel of fluid impermeable film to form a fluid impermeable body including a distal region, a proximal region, a chamber positioned between the first panel and the second panel, and an opening in fluid communication with the chamber.
  • the first panel is positioned at least partially between the distal region and the proximal region and has a first proximal end.
  • the second panel is positioned at least partially between the distal region and the proximal region and has a second proximal end spaced proximally from the first proximal end of the first panel.
  • the method includes inserting a fluid permeable material into the chamber effective to space the first panel from the second panel around the chamber and retain the opening between the first panel and the second panel.
  • the method includes securing a first portion of one or more porous materials to the first panel opposite to the second panel with the first portion of the one or more porous material extending distally from at least proximate to the first proximal end of the first panel.
  • the method includes securing a second portion of the one or more porous materials to the second panel such that the second portion extends proximally from at least proximate to the first proximal end of the first panel and angles or curves from the first panel to the second panel over the opening.
  • the method includes disposing an inlet of a conduit in the chamber with the conduit extending proximally from the fluid collection device.
  • FIG. 2A is a front view of a fluid collection device, according to an embodiment.
  • FIG. 2B is a cross-sectional view of the fluid collection device of FIG. 2A taken along 2B-2B in FIG. 2A.
  • FIG. 3A is a front view of a fluid collection device, according to an embodiment.
  • FIG. 4 is a flow diagram of a method of manufacturing a fluid collection device, according to an embodiment.
  • FIG. 5A is a top isometric view of a portion of fluid permeable material of a conduit, according to an embodiment.
  • FIG. 5B is a side view of the portion of fluid permeable material of FIG. 5A.
  • Fluid collection devices are used to collect fluids such as urine, vaginal discharge, penile discharge, reproductive fluids, blood, sweat, or other bodily fluids from a user.
  • a fluid (e.g., urine) collection device includes a generally a fluid impermeable fdm forming a chamber (e.g, reservoir) with a generally flat fluid permeable material disposed therein.
  • the fluid impermeable film includes two pieces or panels of fluid impermeable film (e.g., plastic film) sealed together to create a chamber (e.g., pocket or chamber pocket) for the fluid permeable material.
  • the configuration of a generally flat fluid permeable material and the fluid impermeable film results in the technical effect of the fluid collection device having a smaller, more flexible profile that allows the fluid collection device to be compatible with a user’s own clothes without reducing the effectiveness of fluid withdrawal from the fluid collection device.
  • the low profile of the fluid collection device, particularly the chamber combined with the flexibility of the fluid impermeable film, enables concealment beneath clothing while enabling fluid collection and subsequent drainage.
  • the generally flat fluid permeable material in the chamber is configured to support the fluid impermeable film, thereby keeping the chamber open for reception of fluid from the user, temporary storage within the chamber, and removal from the chamber through the tube. In at least one.
  • this configuration of the fluid collection device results in the technical effect of a much more comfortable fluid collection device than conventional fluid collection devices, especially for ambulatory users.
  • This configuration of the fluid collection device also results in the technical effect of the fluid collection device being more flexible for positioning than conventional fluid collection devices, as the fluid collection devices of this disclosure do not require placement of the fluid collection device directly between a female user’s labia.
  • the configurations of the fluid collection devices disclosed herein result in the technical effect of the fluid collection device being flexible for use in a wide range of user underwear (e.g., the fluid collection devices are not dependent upon any specific type of underwear use).
  • the tube extending from the fluid collection device may include a fluid impermeable film wrapped and/or sealed around a fluid permeable material effective for form a flexible, flat tube.
  • the fluid permeable material in the tube is configured to prevent the tube from kinking or collapsing when a negative pressure is applied to the tube by the vacuum source. Instead, the fluid permeable material in the tube retains fluid communication between the chamber of the fluid collection device and the vacuum source such that fluid may be withdrawn without unintended interruption when a negative pressure is applied to the tube and the chamber of the fluid collection device.
  • the fluid permeable material in the tube may include the same material as the fluid impermeable material in the chamber of the fluid collection device.
  • the fluid impermeable material in both the chamber and most of the tube may include hydrophobic fluid permeable material.
  • the fluid collection device also may include a hydrophilic material disposed at the inlet of the tube and extending partially into the tube and partially into the chamber. This combination of the hydrophobic material in the chamber and most of the tube improves draining capabilities, while the segment of hydrophilic material improves capture of fluid in the chamber into the conduit for removal.
  • FIG. 1 is a block diagram of a system 10 for fluid collection, according to an embodiment.
  • the system 10 includes a fluid collection device 12, a fluid storage container 14, and a portable vacuum source 16.
  • the fluid collection device 12 may include any of the fluid collection devices disclosed herein, such as the fluid collection device 200. 300.
  • the fluid collection device 12, the fluid storage container 14, and the portable vacuum source 16 may be fluidly coupled to each other via one or more conduits 17.
  • the conduit 17 may include any of the conduits disclosed herein, such as the conduit 208, 308.
  • the fluid collection device 12 may be operably coupled to one or more of the fluid storage container 14 or the portable vacuum source via the conduit 17.
  • Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device 12 may be removed from the fluid collection device 12 via the conduit 17, which protrudes into an interior region of the fluid collection device 12.
  • a first open end of the conduit 17 may extend into the fluid collection device 12 to a reservoir therein.
  • the second open end of the conduit 17 may extend into the fluid storage container 14 or the portable vacuum source 16.
  • the suction force may be introduced into the interior region of the fluid collection device 12 via the first open end of the conduit 17 responsive to a suction (e.g., vacuum) force applied at the second end of the conduit 17.
  • the suction force may be applied to the second open end of the conduit 17 by the portable vacuum source 16 either directly or indirectly.
  • the suction force may be applied indirectly via the fluid storage container 14.
  • the second open end of the conduit 17 may be disposed within the fluid storage container 14 and an additional conduit 17 may extend from the fluid storage container 14 to the portable vacuum source 16.
  • the portable vacuum source 16 may apply suction to the fluid collection device 12 via the fluid storage container 14.
  • the suction force may be applied directly via the fluid storage container 14.
  • the second open end of the conduit 17 may be disposed within the portable vacuum source 16.
  • An additional conduit 17 may extend from the portable vacuum source 16 to a point outside of the fluid collection device 12, such as to the fluid storage container 14.
  • the portable vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.
  • the fluid collection device 12 may be shaped and sized to be positioned adjacent or proximate to a female urethra.
  • the fluid collection member of the fluid collection device 12 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device member) of the fluid collection device 12.
  • the fluid collection device 12 may include a softer, thinner fluid impermeable barrier than conventional fluid collection devices.
  • the fluid impermeable barrier also defines an opening extending therethrough from the external environment. The opening may be positioned on the fluid collection member to be aligned adjacent or proximate to a female urethra.
  • the fluid collection member of the fluid collection device 12 may include a fluid permeable body disposed within the fluid impermeable barrier.
  • the fluid permeably body may include a fluid permeable membrane and fluid permeable support disposed within the fluid permeable membrane.
  • the conduit 17 may extend into the fluid collection device 12 at a first end region, through one or more of the fluid impermeable barrier, fluid permeable membrane, or the fluid permeable support to a second end region of the fluid collection member of the fluid collection device 12.
  • Example fluid collection devices for use with the systems and methods herein are described in more detail below.
  • the fluid storage container 14 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection j ar), or any other enclosed container for storing bodily fluids such as urine.
  • the conduit 17 may extend from the fluid collection device 12 and attach to the fluid storage container 14 at a first point therein.
  • An additional conduit 17 may atach to the fluid storage container 14 at a second point thereon and may extend and atach to the portable vacuum source 16.
  • the fluid storage container 14 may include a container fluidly coupled to a first conduit section that is also fluidly coupled to the fluid collection member of the fluid collection device 12.
  • the container may be fluidly coupled to a second section of the conduit 17 that is also fluidly coupled to a portable vacuum source.
  • the portable vacuum source 16 may provide a vacuum/suction through the container to the fluid collection member to provide suction in the chamber of the fluid collection member. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14. As the fluid is drained from the chamber, the fluid may travel through the first section of conduit to the fluid storage container where it may be retained. Fluid, such as urine, may be drained from the fluid collection device 12 using the portable vacuum source 16.
  • a vacuum e.g., suction
  • the portable vacuum source 16 may be disposed in or on the fluid collection device 12.
  • the conduit 17 may extend from the fluid collection device and attach to the portable vacuum source 16 at a first point therein.
  • An additional conduit 17 may attach to the portable vacuum source 16 at a second point thereon and may extend out of the fluid collection device 12, and may attach to the fluid storage container 14. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14.
  • a vacuum e.g., suction
  • the portable vacuum source 16 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum.
  • the portable vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12.
  • the portable vacuum source 16 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump).
  • the portable vacuum source 16 may be sized and shaped to fit outside of, on, or within the fluid collection device 12.
  • the portable vacuum source 16 may include one or more miniaturized pumps or one or more micro pumps.
  • the portable vacuum sources 16 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the portable vacuum source 16.
  • the portable vacuum sources 16 disclosed herein may provide a portable means of providing a suction or vacuum that allows use of the devices and systems herein outside of hospital or care facility environments where vacuum lines are plumbed into patient rooms or large (e.g., larger or heavier than a patient can readily carry ) vacuum sources are located.
  • a portable vacuum source may be small and light enough to be carried by a user (e.g., patient) or aid (e.g., nurse) during transportation of the user.
  • FIG. 2A is a front view of a fluid collection device 200 and FIG. 2B is a cross-sectional view of the fluid collection device 200 of FIG. 2A.
  • the fluid collection device 200 may include a fluid impermeable film 210 (e.g, fluid impermeable barrier), a fluid permeable material 206, one or more porous materials on the outside of the fluid collection device 200, and a conduit 208.
  • the fluid impermeable film 210 includes a distal region 212 and a proximal region 214.
  • the fluid impermeable film 210 includes two panels of fluid impermeable film 210 sealed or otherwise secured together.
  • the fluid impermeable film 210 may include a first panel 210a of the fluid impermeable film 210 positioned at least partially between the distal region 212 and the proximal region 214 and having a first proximal end 214a disposed between the distal region 212 and the proximal region 214.
  • the fluid impermeable film 210 also may include a second panel 210b positioned at least partially between the distal region 212 and the proximal region 214 and having a second proximal end 214b spaced proximally from the first proximal end 214a of the first panel 210a.
  • the first panel 210a may terminate at the first proximal end 214a before reaching the proximal region 214 and/or the second proximal end 214b.
  • the first proximal end 214a of the first panel includes a generally concave profile that recesses towards the distal region 212.
  • the second proximal end 214b includes a generally convex profile that extends proximally.
  • the first panel 210a and the second panel 210b at least partially define a chamber 216 (e.g., pocket or chamber pocket) therebetween and an opening 207 in fluid communication with the chamber 216.
  • the opening 207 may extending across substantially all of a lateral width of the fluid impermeable film 210.
  • the chamber 216 may extend and narrow distally from the opening 207 and may terminate before the distal region 212 of the fluid impermeable film 210.
  • the chamber 216 may extend less than halfway from the first proximal end 214a of the first panel 210a to the terminating end at the distal region 212 of the fluid impermeable film 210.
  • the chamber 216 may include a profile that is substantially crescent-shaped.
  • the second panel 210b terminates at the distal end of the chamber 216.
  • the second panel 210b may be sealed or secured laterally to the first panel 210a to form distal end of the chamber 216, and the second panel 210b may terminate immediately after the seal at the distal end of the chamber 216.
  • the second panel 210b may extend from the distal end of the chamber 216 to the end of the distal region 212, and the first panel 210a and the second panel 210b may be sealed continuously from the end of the chamber 216 to the end of the distal region 212.
  • the fluid impermeable film 210 includes one or more of a closed cell polyurethane, polyvinyl chloride, and/or a polyethylene foam.
  • the fluid impermeable film 210 may include a thickness of less than about 40 mils, less than about 35 mils, less than about 30 mils, less than about 25 mils, less than about 20 mils, less than about 15 mils, or less than about 10 mils.
  • the fluid impermeable film 210 includes a material configured to be heat sealed together such that the first panel 210a and the second panel 210b may be heat-sealed to form the chamber 216.
  • the fluid permeable material 206 when the chamber 216 is substantially crescent-shaped, the fluid permeable material 206 also may be substantially crescent-shaped generally complementary to the crescent-shape of the chamber 216.
  • the fluid permeable material 206 extends proximally at least partially beyond the first proximal end 214a of the first panel 210. Accordingly, the fluid permeable material 206 extends at least to the first proximal end 214a and/or partially beyond the first proximal end 214a. Thus, the fluid permeable material 206 is sandwiched between the first panel 210a and the second panel 210b in the chamber 216.
  • This configuration promotes retaining the opening 207 and the chamber 216 in an open position to allow fluid to enter the chamber 216 and also allow fluid to be removed from the chamber 216 through the conduit 208.
  • the fluid permeable material 206 may fill substantially all of the chamber 216. Accordingly, the fluid permeable material 206 may extend continuously between the opening 207 of the chamber 216 and the inlet 218 of the conduit 208 disposed in the chamber 216. This configuration may promote flow of fluid from the opening 207 to the inlet 218 of the conduit 208 for removal from the chamber 216.
  • the fluid permeable material 206 may include a high-loft, non-woven material.
  • the fluid permeable material 206 may include a high-loft material that is about 5 gsm to about 20 gsm, about 5 gsm to about 10 gsm, about 7.5 gsm to about 12.5 gsm, about 10 gsm to about 15 gsm, about 12.5 gsm to about 17.5 gsm, or about 15 gsm to about 20 gsm.
  • the fluid permeable material includes a non-woven polyester fiber material having a high loft.
  • the fluid permeable material 206 may include a spacer fabric.
  • the fluid permeable material 206 may include a single, continuous material throughout the chamber 216 (e.g., the fluid impermeable film 210 may include a single-layered material rather than a multiple-layered material).
  • the fluid permeable material 206 includes a maximum or average cross-sectional thickness (shown in FIG. 2B) of about 2 mm to about 6 mm, about 2 mm to about 4 mm, 3 mm to about 5 mm, about 4 mm to about 6 mm, about 2 mm to about 3 mm, about 3 mm to about 4 mm, about 4 mm to about 5 mm, or about 5 mm to about 6 mm.
  • the fluid permeable material 206 may be folded one or more times such that the fluid permeable material includes multiple layers positioned within the chamber 216. These multiple layers may together total any of the thicknesses of the fluid permeable material 206 provided above.
  • the fluid impermeable material 206 may include a layer having a thickness of about 1.5 mm that is folded one or more times such that the fluid permeable material 206 has a total thickness of about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 2 mm to about 3 mm. about 3 mm to about 4 mm, about 4 mm to about 5 mm, or about 5 mm to about 6 mm.
  • the fluid permeable film 206 includes a maximum or average cross-sectional length (shown in FIG. 2B) of about 14 mm to about 24 mm, about
  • the fluid permeable material 206 may include a ‘’wicking feature” that excludes absorption into the fluid permeable material 206. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the fluid permeable material 206 is exposed to the bodily fluids and removed from the bodily fluids for a time.
  • the term ‘"substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into the fluid permeable material 206 (e.g., absorbency), such as less than about 30 wt% of the dry weight of the fluid permeable body 206, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the fluid permeable material 206.
  • absorbency e.g., absorbency
  • the fluid collection device also may include one or more porous materials extending between the proximal region 214 and the distal region 212.
  • the one or more porous materials may be positioned to cover the opening 207 and the side of the fluid impermeable film 210 that is oriented towards the user during use.
  • a first portion 202 of the one or more porous materials may secured to the first panel 210a opposite to the second panel 210b (e.g., oriented to face the user during use) and a second portion 204 of the one or more porous materials may extend proximally from at least proximate to the first proximal end 214a of the first panel 210a.
  • the first portion 202 of the one or more porous material may extend distally from at least proximate to the first proximal end 214a of the first panel 210a.
  • the first portion 202 of the one or more porous materials may be secured (e.g. , adhesively secured) to the first panel 210a at least proximate to the first proximal end
  • the first portion 202 of the one or more porous materials may be shaped generally complementary to the shape of the first panel 210a of the fluid impermeable film 210.
  • the first portion 202 of the one or more materials includes an absorbent material. Accordingly, while the fluid permeable material 206 in the chamber 216 and the wicking material of the second portion 204 (described below) are configured to be substantially non-absorbent, the fluid collection device 200 also includes an absorbent region in the first portion 202 that is configured to absorb fluids that may miss the opening 207 of the chamber 216.
  • the material of the second portion 204 is more absorbent than the material of the fluid permeable material 206 in the chamber 216 and the material of the second portion 204, according to an embodiment.
  • the absorbent material may include a non-woven material, such as a non-woven polyester material, an open cell foam (e.g., polyurethane, diisocyanate, hy drophili c-treated polyethylene), cellulose fibers, non-woven or woven fibers, and/or gel sorbents (e.g., crosslinked sodium polyacrylate polymer beads/granules).
  • the absorbent material may include one or more of a foam, woven, bamboo-fibers, cellulose, biodegradable, linen, hemp, and/or other fibrous material.
  • the second portion 204 of the one or more porous materials may extend proximally from at least proximate to the first proximal end 214a of the first panel 210a and be secured to the second panel 210b such that the second portion 204 extends (e.g., angles or curves) from the first panel 210a to the second panel 210b over the opening 207. Accordingly, the second portion 204 may be secured (e.g.
  • the second portion 204 of the one or more porous materials includes a wicking material (e.g., fluid permeable membrane) extending proximally from at least proximate to the first proximal end 214a of the first panel 210a such that the wicking material extends over the opening 207.
  • the wicking material of the second portion 204 may be positioned on the fluid collection device 200 to contact a region of a user at least proximate to a urethra of the user.
  • the wicking material of the second portion 204 extends proximally to the second proximal end 214b of the second panel 210b.
  • the wicking material of the second portion 204 may include a “‘wicking feature” that excludes absorption into the wicking material of the second portion 204. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the wicking material of the second portion 204 is exposed to the bodily fluids and removed from the bodily fluids for a time.
  • the term ‘‘substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into the wicking material of the second portion 204 (e.g., absorbency), such as less than about 30 wt% of the dry weight of the wicking material, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the wicking material of the second portion 204.
  • the wicking material of the second portion 204 is substantially a hydrophilic material and may have relatively greater absorption in some cases.
  • the wicking material or fluid permeable membrane of the second portion 204 may also wick the fluid generally towards an interior of the chamber 216 where the fluid permeable material 206 is disposed.
  • the wicking material of the second portion 204 may include any material that may wick the fluid.
  • the fluid permeable membrane may include fabric, such as a gauze (e.g., a silk, linen, polymer based materials such as polyester, or cotton gauze), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g., rayon, satin, or the like). Forming the wicking material of the second portion 204 from gauze, soft fabric, and/or smooth fabric may reduce chaffing caused by the fluid collection device 200.
  • the fluid collection device 200 also may include the conduit 208.
  • the conduit 208 includes an inlet 218 positioned in the chamber 216 and may extend proximally from the fluid collection device 200.
  • the conduit 208 may disposed in the chamber 216 between the fluid permeable material 206 and the second panel 210b of the fluid impermeable film 210.
  • the conduit 208 is positioned and/or exits between the wicking material of the second portion 204 and the second panel 210b.
  • the inlet 218 of the conduit 208 may be positioned proximate to but spaced from the distal end of the chamber 216, and the conduit 208 may then extend between the second panel 210b and the wicking material of the second portion 204 until the conduit 208 extends proximally from the fluid collection device 200 between the second panel 210b and the wicking material of the second portion 204.
  • the inlet 218 of the conduit 208 is disposed adjacent to and/or interfacing with the fluid permeable material 206 in the chamber 216.
  • the fluid permeable material 206 includes a distal lip 217 or recessed region that prevents or inhibits the inlet 218 of the conduit 208 from interfacing or contacting the distal end of the chamber 216 (and blocking suction of the conduit 208).
  • the fluid permeable material 206 includes a bore sized to receive a portion of the conduit 208 including the inlet 218, with the bore terminating before extending all the way through the fluid permeable material 206. This bore, then prevents the inlet 218 from interfacing or contacting the distal end of the chamber 216.
  • the conduit 208 may include a flexible material such as plastic tubing (e.g, medical tubing).
  • plastic tubing may include a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing.
  • the conduit 208 may include silicone or latex.
  • a fluid collection device may include a conduit formed from a fluid impermeable film and having a fluid permeable material disposed therein.
  • FIG. 3A is a front view of a fluid collection device 300
  • FIG. 3B is a cross-sectional view of the fluid collection device 300 of FIG. 3A, according to an embodiment.
  • the fluid collection device 300 may include any aspect of the fluid collection device 200.
  • the additional fluid impermeable film of the conduit 308 may include any film described above in relation to the fluid impermeable film 210.
  • the additional fluid impermeable film of the conduit 308 includes a panel of the fluid impermeable film folded over itself and heat-, solvent-, or adhesive-sealed along a seam to form the conduit 308.
  • the conduit 308 includes two panels of the additional fluid impermeable film heat, solvent, or adhesive-sealed together on two opposing longitudinal edges to form the conduit 308.
  • the additional fluid impermeable film of the conduit 308 includes a heat-shrinkable film that is heat shrunk around the additional fluid permeable material 326.
  • the conduit 308 and the additional fluid permeable material 326 may be configured such that the additional fluid permeable material 326 always extend at least to the inlet 318 and/or beyond the inlet 318.
  • the additional fluid impermeable film of the conduit 308 may be configured to form a tight fit around the additional fluid permeable material 326 such that the additional fluid permeable 326 material is not movable within the conduit 308.
  • the additional fluid impermeable film of the conduit 308 may be heat shrunk around the additional fluid permeable material
  • the additional fluid permeable material 326 may have a cross-sectional thickness (shown in FIG. 3B) of about 0.25 cm to about 1.5 cm. about 0.25 cm to about 0.75 cm. about 0.50 cm to about 1.0 cm. about 0.75 cm to about 1.25 cm, about
  • the additional fluid permeable material 326 may include any of the materials and characteristics described above in relation to the fluid permeable material 206 disposed in the chamber 216.
  • at least some (e.g, all) of the additional fluid permeable material 326 may include a non-woven polyester fiber material.
  • the fluid permeable material 206 in the chamber 216 includes a hydrophobic material.
  • the additional fluid permeable material 326 may include both a hydrophilic region 326a extending outward from the inlet 318 into the chamber 216 and a hydrophobic region 326b positioned within the conduit 308. This configuration results in the technical effect of improved draining capabilities of the fluid collection device 300.
  • the hydrophilic region 326a may be integrally formed with or otherwise secured to the hydrophobic region 326b.
  • the additional fluid permeable material 326 includes a non-linear configuration within the conduit 308.
  • the additional fluid permeable material includes one or more of longitudinal ridges 324, posts, and/or dimples 328 on a surface of the additional fluid permeable material 326.
  • the additional fluid impermeable film of the conduit 308 may be sealed around the additional fluid permeable material 326 and the longitudinal ridges 324, posts, and/or dimples 328 promote an open configuration of the conduit 308. Even with the one or more of longitudinal ridges 324.
  • the fluid collection device 300 also may include an adapter secured or securable to the conduit 308 at a predetermined distance from the fluid impermeable panel 210 and configured to secure to a tube or conduit that provides the negative pressure from the vacuum source for fluid removal from the fluid collection device 300.
  • FIG. 5A is a top isometric view of a portion of a fluid permeable material 526 of a conduit, according to an embodiment
  • FIG. 5B is a side view of the portion of the fluid permeable matenal 526 of FIG. 5A.
  • the fluid permeable material 526 may be used with the conduit 308 (e.g, the fluid permeable material 526 may replace the fluid permeable material 326 in the conduit 308). Only a portion of the fluid permeable material 526 is shown, and the fluid permeable material 526 may include any shape and/or configuration shown and/or described in relation to the fluid permeable material 326.
  • the fluid permeable material 526 may include any aspect of the fluid permeable material 326, including but not limited to the materials, thicknesses, and/or features of the fluid permeable material 326.
  • the fluid permeable material 526 may be printed three-dimensionally.
  • the fluid permeable material 526 may include a thermoformed elastomer that is cast, embossed, thermoformed, or extruded.
  • the fluid permeable material 526 may include a substantially planar surface 525 having raised protuberances 528.
  • the protuberances 528 may include posts that are rounded and/or have a circular profile. In some embodiments, at least some (e.g, all) of the protuberances 528 may be raised from the surface 525 about 1.5 mils to about 5.0 mils, about 1.5 mils to about 2.0 mils, about 1.75 mils to about 2.25 mils, about 2.0 mils to about 2.5 mils, about 2.25 mils to about 2.75 mils, about 2.5 mils to about 3.0 mils, about 2.75 mils to about 3.25 mils, about 3.0 mils to about 3.5 mils, about 3.25 mils to about 3.75 mils, about 3.5 mils to about 4.0 mils, about 3.75 mils to about 4.25 mils, about 4.0 mils to about 4.5 mils, about 4.25 mils to about 4.75 mils, or about 4.5 mils to about 5.0 mils.
  • the fluid permeable material also may include an edge 524 raised from the surface 525 and defining a trough.
  • the raised edge 524 and/or the protuberances 528 result in the technical effect of maintaining a fluid path through the conduit 308, even when the conduit 308 is under a negative pressure.
  • the raised edge 524 and/or the protuberances 528 also may reduce the sound of fluid flowing through the conduit 308 during use.
  • FIG. 4 is a flow diagram of a method 400 of manufacturing a fluid collection device, according to an embodiment.
  • the method 400 may be performed to form any of the fluid collection devices 200, 300 described herein.
  • the method 400 includes an act 405 of securing a first panel of fluid impermeable film to a second panel of fluid impermeable film to form a fluid impermeable body including a distal region, a proximal region, a chamber positioned between the first panel and the second panel, and an opening in fluid communication with the chamber.
  • the first panel may be positioned at least partially between the distal region and the proximal region and having a first proximal end
  • the second panel may be positioned at least partially between the distal region and the proximal region and have a second proximal end spaced proximally from the first proximal end of the first panel.
  • the method 400 also may include an act 410 of inserting a fluid permeable material into the chamber effective to space the first panel from the second panel around the chamber and retain the opening between the first panel and the second panel.
  • the method 400 also may include an act 415 of securing a first portion of one or more porous materials to the first panel opposite to the second panel with the first portion of the one or more porous material extending distally from at least proximate to the first proximal end of the first panel.
  • the method 400 also may include an act 420 of securing a second portion of the one or more porous materials to the second panel such that the second portion extends proximally from at least proximate to the first proximal end of the first panel and extends from the first panel to the second panel over the opening.
  • the method also may include an act 425 of disposing an inlet of a conduit in the chamber with the conduit extending proximally from the fluid collection device.
  • the first portion of the one more porous materials includes an absorbent material secured to the first panel opposite to the second panel and extending distally from at least proximate to the first proximal end of the first panel.
  • the second portion of the one or more porous materials includes a wicking material extending proximally from at least proximate to the first proximal end of the first panel such that the wicking material extends over the opening.
  • the wicking material may be positioned on the fluid collection device to contact a region of a user at least proximate to a urethra of the user.
  • the wicking material may extend proximally to the second proximal end of the second panel, and the conduit may be positioned between the wicking material and the second panel.
  • the fluid permeable material includes a non-woven polyester fiber material.
  • the act 405 of securing a first panel of fluid impermeable film to a second panel of fluid impermeable film may include sealing the first panel to the second panel, according to an embodiment.
  • the method 400 may further comprise an act of inserting an additional fluid permeable material into the conduit.
  • the method 400 may further comprise an act of forming the conduit with an additional fluid impermeable film before inserting the additional fluid permeable material into the conduit.
  • the additional fluid permeable material may retain the conduit in fluid communication with the chamber when a vacuum pressure is applied to the conduit.
  • the additional fluid permeable material may extend from the inlet of the conduit and into the chamber, and at least some of the additional fluid permeable material includes anon-woven polyester fiber material.
  • the fluid permeable material in the chamber includes a hydrophobic material and the additional fluid permeable material includes a hydrophilic region extend outward from the inlet into the chamber and a hydrophobic region positioned within the conduit.
  • the additional fluid permeable material includes a non-linear configuration and/or one or more of longitudinal ridges, posts, and/or dimples on a surface of the additional fluid permeable material.
  • the method 400 further comprises an act of heat shrinking the fluid impermeable around the additional fluid permeable material.
  • Acts of the method 400 are for illustrative purposes.
  • the acts of the method 400 may be performed in different orders, split into multiple acts, modified. supplemented, or combined.
  • the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ⁇ 10% or ⁇ 5%. Further, the terms “less than,” “or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.” [0059] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiment disclosed herein are for purposes of illustration and are not intended to be limiting.

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Abstract

Embodiments disclosed herein are methods of manufacture of fluid collection devices, and related systems and devices. In an embodiment, the fluid collection device includes a fluid impermeable film defining a chamber, a fluid permeable material positioned within the chamber, one or more porous materials position on the fluid collection device to contact the user, and a conduit having an inlet positioned in the chamber and extending proximally from the fluid collection device.

Description

FLUID COLLECTION DEVICES INCLUDING A FLUID IMPERMEABLE FILM AND FLAT FLUID PERMEABLE MATERIAL DISPOSED THEREIN, AND RELATED SYSTEMS AND METHODS
BACKGROUND
[0001] An individual may have limited or impaired mobility such that typical urination processes are challenging or impossible. For example, the individual may have surgery or a disability that impairs mobility. In another example, the individual may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, fluid collection from the individual may be needed for monitoring purposes or clinical testing.
[0002] Bed pans and urinary catheters, such as a Foley catheter, can be used to address some of these circumstances. However, bed pans and urinary catheters have several problems associated therewith. For example, bed pans can be prone to discomfort, pressure ulcers spills, and other hygiene issues. Urinary catheters be can be uncomfortable, painful, and can cause urinary' tract infections.
[0003] Thus, users and manufacturers of fluid collection devices continue to seek new and improved devices, systems, and methods to collect urine.
SUMMARY
[0004] Embodiments disclosed herein include fluid collection devices, and related assemblies, systems, and methods of manufacture. In an embodiment, a fluid collection device is disclosed. The fluid collection device includes a fluid impermeable film including a distal region, a proximal region, a first panel positioned at least partially between the distal region and the proximal region and having a first proximal end, and a second panel positioned at least partially between the distal region and the proximal region and having a second proximal end spaced proximally from the first proximal end of the first panel. The first panel and the second panel at least partially define a chamber therebetween and an opening in fluid communication with the chamber. The fluid collection device includes a fluid permeable material positioned within the chamber and configured to space the first panel from the second panel and retain the opening between the first panel and the second panel. The fluid collection device includes one or more porous materials extending between the proximal region and the distal region. A first portion of the one or more porous materials is secured to the first panel opposite to the second panel and extends distally from at least proximate to the first proximal end of the first panel. A second portion of the one or more porous materials extends proximally from at least proximate to the first proximal end of the first panel and is secured to the second panel such that the second portion extends from the first panel to the second panel over the opening. The fluid collection device includes a conduit having an inlet positioned in the chamber and extending proximally from the fluid collection device.
[0005] In an embodiment, a fluid collection device is disclosed. The fluid collection device includes a fluid impermeable barrier defining a chamber and an opening in fluid communication with the chamber. The fluid collection device includes a fluid permeable material positioned within the chamber and configured to space apart the fluid impermeable barrier and retain the opening in the fluid impermeable barrier, the fluid permeable material including a hydrophobic material. The fluid collection device includes a conduit having an inlet positioned in the chamber and extend outward from the fluid impermeable barrier. The conduit includes an additional fluid permeable material positioned within the conduit having a hydrophilic region extending outward from the inlet into the chamber and a hydrophobic region positioned within the conduit.
[0006] In an embodiment, a method of manufacturing a fluid collection device is disclosed. The method includes securing a first panel of fluid impermeable film to a second panel of fluid impermeable film to form a fluid impermeable body including a distal region, a proximal region, a chamber positioned between the first panel and the second panel, and an opening in fluid communication with the chamber. The first panel is positioned at least partially between the distal region and the proximal region and has a first proximal end. The second panel is positioned at least partially between the distal region and the proximal region and has a second proximal end spaced proximally from the first proximal end of the first panel. The method includes inserting a fluid permeable material into the chamber effective to space the first panel from the second panel around the chamber and retain the opening between the first panel and the second panel. The method includes securing a first portion of one or more porous materials to the first panel opposite to the second panel with the first portion of the one or more porous material extending distally from at least proximate to the first proximal end of the first panel. The method includes securing a second portion of the one or more porous materials to the second panel such that the second portion extends proximally from at least proximate to the first proximal end of the first panel and angles or curves from the first panel to the second panel over the opening. The method includes disposing an inlet of a conduit in the chamber with the conduit extending proximally from the fluid collection device.
[0007] Features from any of the 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.
[0009] FIG. 1A is a block diagram of a system for fluid collection, according to an embodiment.
[0010] FIG. 2A is a front view of a fluid collection device, according to an embodiment. [0011] FIG. 2B is a cross-sectional view of the fluid collection device of FIG. 2A taken along 2B-2B in FIG. 2A.
[0012] FIG. 3A is a front view of a fluid collection device, according to an embodiment.
[0013] FIG. 3B is a cross-sectional view of the fluid collection device of FIG. 3A taken along 3B-3B in FIG. 3A.
[0014] FIG. 4 is a flow diagram of a method of manufacturing a fluid collection device, according to an embodiment.
[0015] FIG. 5A is a top isometric view of a portion of fluid permeable material of a conduit, according to an embodiment. [0016] FIG. 5B is a side view of the portion of fluid permeable material of FIG. 5A.
DETAILED DESCRIPTION
[0017] Fluid collection devices are used to collect fluids such as urine, vaginal discharge, penile discharge, reproductive fluids, blood, sweat, or other bodily fluids from a user. In at least one, some, or all embodiments disclosed herein, a fluid (e.g., urine) collection device includes a generally a fluid impermeable fdm forming a chamber (e.g, reservoir) with a generally flat fluid permeable material disposed therein. In some embodiments, the fluid impermeable film includes two pieces or panels of fluid impermeable film (e.g., plastic film) sealed together to create a chamber (e.g., pocket or chamber pocket) for the fluid permeable material. In some embodiments, the fluid collection device also may include a soft wicking material at least partially (e.g.. entirely) covering the opening to the chamber and positioned to contact the user at least proximate to the urethra. In some embodiments, the fluid collection device also may include an absorbent material on a user-facing side of the fluid impermeable fdm. Fluid collection devices also may include a tube (e.g., conduit) exiting the chamber and configured to provide fluid communication between a vacuum source and the chamber such that fluid in the chamber may be transferred out of the chamber when a negative pressure is applied to the conduit. [0018] The configuration of a generally flat fluid permeable material and the fluid impermeable film results in the technical effect of the fluid collection device having a smaller, more flexible profile that allows the fluid collection device to be compatible with a user’s own clothes without reducing the effectiveness of fluid withdrawal from the fluid collection device. In other words, the low profile of the fluid collection device, particularly the chamber, combined with the flexibility of the fluid impermeable film, enables concealment beneath clothing while enabling fluid collection and subsequent drainage. For example, the generally flat fluid permeable material in the chamber is configured to support the fluid impermeable film, thereby keeping the chamber open for reception of fluid from the user, temporary storage within the chamber, and removal from the chamber through the tube. In at least one. some, or all embodiments, this configuration of the fluid collection device results in the technical effect of a much more comfortable fluid collection device than conventional fluid collection devices, especially for ambulatory users. This configuration of the fluid collection device also results in the technical effect of the fluid collection device being more flexible for positioning than conventional fluid collection devices, as the fluid collection devices of this disclosure do not require placement of the fluid collection device directly between a female user’s labia. The configurations of the fluid collection devices disclosed herein result in the technical effect of the fluid collection device being flexible for use in a wide range of user underwear (e.g., the fluid collection devices are not dependent upon any specific type of underwear use). [0019] In at least one, some, or all embodiments disclosed herein, the tube extending from the fluid collection device may include a fluid impermeable film wrapped and/or sealed around a fluid permeable material effective for form a flexible, flat tube. The fluid permeable material in the tube, however, is configured to prevent the tube from kinking or collapsing when a negative pressure is applied to the tube by the vacuum source. Instead, the fluid permeable material in the tube retains fluid communication between the chamber of the fluid collection device and the vacuum source such that fluid may be withdrawn without unintended interruption when a negative pressure is applied to the tube and the chamber of the fluid collection device. In some embodiments, at least some of the fluid permeable material in the tube may include the same material as the fluid impermeable material in the chamber of the fluid collection device. For example, the fluid impermeable material in both the chamber and most of the tube may include hydrophobic fluid permeable material. The fluid collection device, however, also may include a hydrophilic material disposed at the inlet of the tube and extending partially into the tube and partially into the chamber. This combination of the hydrophobic material in the chamber and most of the tube improves draining capabilities, while the segment of hydrophilic material improves capture of fluid in the chamber into the conduit for removal.
[0020] FIG. 1 is a block diagram of a system 10 for fluid collection, according to an embodiment. The system 10 includes a fluid collection device 12, a fluid storage container 14, and a portable vacuum source 16. The fluid collection device 12 may include any of the fluid collection devices disclosed herein, such as the fluid collection device 200. 300. The fluid collection device 12, the fluid storage container 14, and the portable vacuum source 16 may be fluidly coupled to each other via one or more conduits 17. The conduit 17 may include any of the conduits disclosed herein, such as the conduit 208, 308. The fluid collection device 12 may be operably coupled to one or more of the fluid storage container 14 or the portable vacuum source via the conduit 17. Fluid (e.g., urine or other bodily fluids) collected in the fluid collection device 12 may be removed from the fluid collection device 12 via the conduit 17, which protrudes into an interior region of the fluid collection device 12. For example, a first open end of the conduit 17 may extend into the fluid collection device 12 to a reservoir therein. The second open end of the conduit 17 may extend into the fluid storage container 14 or the portable vacuum source 16. The suction force may be introduced into the interior region of the fluid collection device 12 via the first open end of the conduit 17 responsive to a suction (e.g., vacuum) force applied at the second end of the conduit 17. The suction force may be applied to the second open end of the conduit 17 by the portable vacuum source 16 either directly or indirectly.
[0021] The suction force may be applied indirectly via the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the fluid storage container 14 and an additional conduit 17 may extend from the fluid storage container 14 to the portable vacuum source 16. Accordingly, the portable vacuum source 16 may apply suction to the fluid collection device 12 via the fluid storage container 14. The suction force may be applied directly via the fluid storage container 14. For example, the second open end of the conduit 17 may be disposed within the portable vacuum source 16. An additional conduit 17 may extend from the portable vacuum source 16 to a point outside of the fluid collection device 12, such as to the fluid storage container 14. In such examples, the portable vacuum source 16 may be disposed between the fluid collection device 12 and the fluid storage container 14.
[0022] The fluid collection device 12 may be shaped and sized to be positioned adjacent or proximate to a female urethra. The fluid collection member of the fluid collection device 12 may include a fluid impermeable barrier at least partially defining a chamber (e.g., interior region of the fluid collection device member) of the fluid collection device 12. As described in more detail above, the fluid collection device 12 may include a softer, thinner fluid impermeable barrier than conventional fluid collection devices. The fluid impermeable barrier also defines an opening extending therethrough from the external environment. The opening may be positioned on the fluid collection member to be aligned adjacent or proximate to a female urethra. The fluid collection member of the fluid collection device 12 may include a fluid permeable body disposed within the fluid impermeable barrier. The fluid permeably body may include a fluid permeable membrane and fluid permeable support disposed within the fluid permeable membrane. The conduit 17 may extend into the fluid collection device 12 at a first end region, through one or more of the fluid impermeable barrier, fluid permeable membrane, or the fluid permeable support to a second end region of the fluid collection member of the fluid collection device 12. Example fluid collection devices for use with the systems and methods herein are described in more detail below. [0023] In some embodiments, the fluid storage container 14 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection j ar), or any other enclosed container for storing bodily fluids such as urine. In examples, the conduit 17 may extend from the fluid collection device 12 and attach to the fluid storage container 14 at a first point therein. An additional conduit 17 may atach to the fluid storage container 14 at a second point thereon and may extend and atach to the portable vacuum source 16. For example, the fluid storage container 14 may include a container fluidly coupled to a first conduit section that is also fluidly coupled to the fluid collection member of the fluid collection device 12. The container may be fluidly coupled to a second section of the conduit 17 that is also fluidly coupled to a portable vacuum source. In such examples, the portable vacuum source 16 may provide a vacuum/suction through the container to the fluid collection member to provide suction in the chamber of the fluid collection member. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14. As the fluid is drained from the chamber, the fluid may travel through the first section of conduit to the fluid storage container where it may be retained. Fluid, such as urine, may be drained from the fluid collection device 12 using the portable vacuum source 16.
[0024] In some embodiments, the portable vacuum source 16 may be disposed in or on the fluid collection device 12. In such examples, the conduit 17 may extend from the fluid collection device and attach to the portable vacuum source 16 at a first point therein. An additional conduit 17 may attach to the portable vacuum source 16 at a second point thereon and may extend out of the fluid collection device 12, and may attach to the fluid storage container 14. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection device 12 via the fluid storage container 14. [0025] The portable vacuum source 16 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The portable vacuum source 16 may provide a vacuum or suction to remove fluid from the fluid collection member of the fluid collection device 12. In some embodiments, the portable vacuum source 16 may be powered by one or more of a power cord (e.g., connected to a power socket), one or more batteries, or even manual power (e.g., a hand operated vacuum pump). In examples, the portable vacuum source 16 may be sized and shaped to fit outside of, on, or within the fluid collection device 12. For example, the portable vacuum source 16 may include one or more miniaturized pumps or one or more micro pumps. The portable vacuum sources 16 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the portable vacuum source 16. It should be understood that the portable vacuum sources 16 disclosed herein may provide a portable means of providing a suction or vacuum that allows use of the devices and systems herein outside of hospital or care facility environments where vacuum lines are plumbed into patient rooms or large (e.g., larger or heavier than a patient can readily carry ) vacuum sources are located. For example, a portable vacuum source may be small and light enough to be carried by a user (e.g., patient) or aid (e.g., nurse) during transportation of the user.
[0026] Turning ahead in the drawings, FIG. 2A is a front view of a fluid collection device 200 and FIG. 2B is a cross-sectional view of the fluid collection device 200 of FIG. 2A. according to an embodiment. The fluid collection device 200 may include a fluid impermeable film 210 (e.g, fluid impermeable barrier), a fluid permeable material 206, one or more porous materials on the outside of the fluid collection device 200, and a conduit 208.
[0027] The fluid impermeable film 210 includes a distal region 212 and a proximal region 214. In some embodiments, the fluid impermeable film 210 includes two panels of fluid impermeable film 210 sealed or otherwise secured together. For example, the fluid impermeable film 210 may include a first panel 210a of the fluid impermeable film 210 positioned at least partially between the distal region 212 and the proximal region 214 and having a first proximal end 214a disposed between the distal region 212 and the proximal region 214. The fluid impermeable film 210 also may include a second panel 210b positioned at least partially between the distal region 212 and the proximal region 214 and having a second proximal end 214b spaced proximally from the first proximal end 214a of the first panel 210a. In other words, the first panel 210a may terminate at the first proximal end 214a before reaching the proximal region 214 and/or the second proximal end 214b. In some embodiments, the first proximal end 214a of the first panel includes a generally concave profile that recesses towards the distal region 212. In some embodiments, the second proximal end 214b includes a generally convex profile that extends proximally. [0028] The first panel 210a and the second panel 210b at least partially define a chamber 216 (e.g., pocket or chamber pocket) therebetween and an opening 207 in fluid communication with the chamber 216. The opening 207 may extending across substantially all of a lateral width of the fluid impermeable film 210. The chamber 216 may extend and narrow distally from the opening 207 and may terminate before the distal region 212 of the fluid impermeable film 210. For example, the chamber 216 may extend less than halfway from the first proximal end 214a of the first panel 210a to the terminating end at the distal region 212 of the fluid impermeable film 210. In some embodiments, the chamber 216 may include a profile that is substantially crescent-shaped. The second panel 210b terminates at the distal end of the chamber 216. For example, the second panel 210b may be sealed or secured laterally to the first panel 210a to form distal end of the chamber 216, and the second panel 210b may terminate immediately after the seal at the distal end of the chamber 216. In some embodiments, the second panel 210b may extend from the distal end of the chamber 216 to the end of the distal region 212, and the first panel 210a and the second panel 210b may be sealed continuously from the end of the chamber 216 to the end of the distal region 212.
[0029] The fluid impermeable film may include a fluid impermeable polyurethane film and/or a polyethylene film. In some embodiments, the fluid impermeable film 210 may include a thickness of about 1.5 mils to about 5.0 mils, about 1.5 mils to about 2.0 mils, about 1.75 mils to about 2.25 mils, about 2.0 mils to about 2.5 mils, about 2.25 mils to about 2.75 mils, about 2.5 mils to about 3.0 mils, about 2.75 mils to about 3.25 mils, about 3.0 mils to about 3.5 mils, about 3.25 mils to about 3.75 mils, about 3.5 mils to about 4.0 mils, about 3.75 mils to about 4.25 mils, about 4.0 mils to about 4.5 mils, about 4.25 mils to about 4.75 mils, about 4.5 mils to about 5.0 mils, less than about 5.0 mils, less than about 4.5 mils, less than about 4.0 mils, less than about 3.5 mils, less than about 3.0 mils, less than about 2.75 mils, less than about 2.5 mils, less than about 2.25 mils, less than about 2.0 mils, less than about 1.75 mils, less than about 1.5 mils, or less than about 1.25 mils. In some embodiments, the fluid impermeable film 210 includes one or more of a closed cell polyurethane, polyvinyl chloride, and/or a polyethylene foam. In these and other embodiments, the fluid impermeable film 210 may include a thickness of less than about 40 mils, less than about 35 mils, less than about 30 mils, less than about 25 mils, less than about 20 mils, less than about 15 mils, or less than about 10 mils. In many embodiments, the fluid impermeable film 210 includes a material configured to be heat sealed together such that the first panel 210a and the second panel 210b may be heat-sealed to form the chamber 216.
[0030] The fluid collection device 200 also includes the fluid permeable material 206 positioned within the chamber 216. The fluid permeable material 206 is configured to space the first panel 210a from the second panel 210b in the chamber 216 even when a negative pressure is applied to the chamber 216, thereby retaining the opening 207 between the first panel 210a and the second panel 210b. The fluid permeable material 206 is sized to extend from a distal end of the chamber 216 to at least the first proximal end 214a of the first panel 210a. In some embodiments, the fluid permeable material 206 is shaped generally complementary to the shape of the chamber 216. For example, when the chamber 216 is substantially crescent-shaped, the fluid permeable material 206 also may be substantially crescent-shaped generally complementary to the crescent-shape of the chamber 216. In some embodiments, the fluid permeable material 206 extends proximally at least partially beyond the first proximal end 214a of the first panel 210. Accordingly, the fluid permeable material 206 extends at least to the first proximal end 214a and/or partially beyond the first proximal end 214a. Thus, the fluid permeable material 206 is sandwiched between the first panel 210a and the second panel 210b in the chamber 216. This configuration promotes retaining the opening 207 and the chamber 216 in an open position to allow fluid to enter the chamber 216 and also allow fluid to be removed from the chamber 216 through the conduit 208. The fluid permeable material 206 may fill substantially all of the chamber 216. Accordingly, the fluid permeable material 206 may extend continuously between the opening 207 of the chamber 216 and the inlet 218 of the conduit 208 disposed in the chamber 216. This configuration may promote flow of fluid from the opening 207 to the inlet 218 of the conduit 208 for removal from the chamber 216.
[0031] The fluid permeable material 206 may include a material configured to provide a porous three-dimensional structure. In some embodiments, the fluid permeable material
206 may include a high-loft, non-woven material. For example, the fluid permeable material 206 may include a high-loft material that is about 5 gsm to about 20 gsm, about 5 gsm to about 10 gsm, about 7.5 gsm to about 12.5 gsm, about 10 gsm to about 15 gsm, about 12.5 gsm to about 17.5 gsm, or about 15 gsm to about 20 gsm. In a particular example, the fluid permeable material includes a non-woven polyester fiber material having a high loft. The fluid permeable material 206 may include a spacer fabric. The fluid permeable material 206 may include a single, continuous material throughout the chamber 216 (e.g., the fluid impermeable film 210 may include a single-layered material rather than a multiple-layered material). In some embodiments, the fluid permeable material 206 includes a maximum or average cross-sectional thickness (shown in FIG. 2B) of about 2 mm to about 6 mm, about 2 mm to about 4 mm, 3 mm to about 5 mm, about 4 mm to about 6 mm, about 2 mm to about 3 mm, about 3 mm to about 4 mm, about 4 mm to about 5 mm, or about 5 mm to about 6 mm. In some embodiments, the fluid permeable material 206 may be folded one or more times such that the fluid permeable material includes multiple layers positioned within the chamber 216. These multiple layers may together total any of the thicknesses of the fluid permeable material 206 provided above. For example, the fluid impermeable material 206 may include a layer having a thickness of about 1.5 mm that is folded one or more times such that the fluid permeable material 206 has a total thickness of about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 2 mm to about 3 mm. about 3 mm to about 4 mm, about 4 mm to about 5 mm, or about 5 mm to about 6 mm.
[0032] In some embodiments, the fluid permeable film 206 includes a maximum or average cross-sectional length (shown in FIG. 2B) of about 14 mm to about 24 mm, about
14 mm to about 19 mm, about 19 mm to about 24 mm. about 14 mm to about 16 mm, about
15 mm to about 17 mm, about 16 mm to about 18 mm, about 17 mm to about 19 mm, about 18 mm to about 20 mm, about 19 mm to about 21 mm, about 20 mm to about 22 mm, about 21 mm to about 23 mm, or about 22 mm to about 24 mm.
[0033] The fluid permeable material 206 may include a ‘’wicking feature” that excludes absorption into the fluid permeable material 206. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the fluid permeable material 206 is exposed to the bodily fluids and removed from the bodily fluids for a time. While no absorption or solubility is desired, the term ‘"substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into the fluid permeable material 206 (e.g., absorbency), such as less than about 30 wt% of the dry weight of the fluid permeable body 206, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the fluid permeable material 206.
[0034] The fluid collection device also may include one or more porous materials extending between the proximal region 214 and the distal region 212. The one or more porous materials may be positioned to cover the opening 207 and the side of the fluid impermeable film 210 that is oriented towards the user during use. In some embodiments, a first portion 202 of the one or more porous materials may secured to the first panel 210a opposite to the second panel 210b (e.g., oriented to face the user during use) and a second portion 204 of the one or more porous materials may extend proximally from at least proximate to the first proximal end 214a of the first panel 210a.
[0035] The first portion 202 of the one or more porous material may extend distally from at least proximate to the first proximal end 214a of the first panel 210a. In some embodiments, the first portion 202 of the one or more porous materials may be secured (e.g. , adhesively secured) to the first panel 210a at least proximate to the first proximal end
214a and/or may extend distally and continuously from the first proximal end 214a to the end of the distal region 212. More specifically, the first portion 202 of the one or more porous materials may be shaped generally complementary to the shape of the first panel 210a of the fluid impermeable film 210. [0036] In some embodiments, the first portion 202 of the one or more materials includes an absorbent material. Accordingly, while the fluid permeable material 206 in the chamber 216 and the wicking material of the second portion 204 (described below) are configured to be substantially non-absorbent, the fluid collection device 200 also includes an absorbent region in the first portion 202 that is configured to absorb fluids that may miss the opening 207 of the chamber 216. Accordingly, the material of the second portion 204 is more absorbent than the material of the fluid permeable material 206 in the chamber 216 and the material of the second portion 204, according to an embodiment. The absorbent material may include a non-woven material, such as a non-woven polyester material, an open cell foam (e.g., polyurethane, diisocyanate, hy drophili c-treated polyethylene), cellulose fibers, non-woven or woven fibers, and/or gel sorbents (e.g., crosslinked sodium polyacrylate polymer beads/granules). In some embodiments, the absorbent material may include one or more of a foam, woven, bamboo-fibers, cellulose, biodegradable, linen, hemp, and/or other fibrous material. [0037] The second portion 204 of the one or more porous materials may extend proximally from at least proximate to the first proximal end 214a of the first panel 210a and be secured to the second panel 210b such that the second portion 204 extends (e.g., angles or curves) from the first panel 210a to the second panel 210b over the opening 207. Accordingly, the second portion 204 may be secured (e.g. with an adhesive) to the first panel 210a proximate to the first proximal end 214a and to the second panel 210b at least proximate to the second proximal end 214b. In some embodiments, the second portion 204 of the one or more porous materials includes a wicking material (e.g., fluid permeable membrane) extending proximally from at least proximate to the first proximal end 214a of the first panel 210a such that the wicking material extends over the opening 207. The wicking material of the second portion 204 may be positioned on the fluid collection device 200 to contact a region of a user at least proximate to a urethra of the user. In some embodiments, the wicking material of the second portion 204 extends proximally to the second proximal end 214b of the second panel 210b.
[0038] The wicking material of the second portion 204 may include a “‘wicking feature” that excludes absorption into the wicking material of the second portion 204. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the wicking material of the second portion 204 is exposed to the bodily fluids and removed from the bodily fluids for a time. While no absorption or solubility is desired, the term ‘‘substantially no absorption” may allow for nominal amounts of absorption and/or solubility of the bodily fluids into the wicking material of the second portion 204 (e.g., absorbency), such as less than about 30 wt% of the dry weight of the wicking material, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the wicking material of the second portion 204. In some embodiments, the wicking material of the second portion 204 is substantially a hydrophilic material and may have relatively greater absorption in some cases.
[0039] The wicking material or fluid permeable membrane of the second portion 204 may also wick the fluid generally towards an interior of the chamber 216 where the fluid permeable material 206 is disposed. The wicking material of the second portion 204 may include any material that may wick the fluid. For example, the fluid permeable membrane may include fabric, such as a gauze (e.g., a silk, linen, polymer based materials such as polyester, or cotton gauze), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g., rayon, satin, or the like). Forming the wicking material of the second portion 204 from gauze, soft fabric, and/or smooth fabric may reduce chaffing caused by the fluid collection device 200. Other embodiments of fluid permeable membranes and wicking material are disclosed in U.S. Patent Application No. 15/612,325 filed on June 2, 2017; U.S. Patent Application No. 15/260,103 filed on September 8, 2016; U.S. Patent Application No. 15/611,587 filed on June 1, 2017; PCT Patent Application No. PCT/US 19/29608, filed on April 29. 2019, the disclosure of each of which is incorporated herein, in its entirety, by this reference.
[0040] The fluid collection device 200 also may include the conduit 208. The conduit 208 includes an inlet 218 positioned in the chamber 216 and may extend proximally from the fluid collection device 200. The conduit 208 may disposed in the chamber 216 between the fluid permeable material 206 and the second panel 210b of the fluid impermeable film 210. In some embodiments, the conduit 208 is positioned and/or exits between the wicking material of the second portion 204 and the second panel 210b. For example, the inlet 218 of the conduit 208 may be positioned proximate to but spaced from the distal end of the chamber 216, and the conduit 208 may then extend between the second panel 210b and the wicking material of the second portion 204 until the conduit 208 extends proximally from the fluid collection device 200 between the second panel 210b and the wicking material of the second portion 204. In some embodiments, the inlet 218 of the conduit 208 is disposed adjacent to and/or interfacing with the fluid permeable material 206 in the chamber 216. In some embodiments, the fluid permeable material 206 includes a distal lip 217 or recessed region that prevents or inhibits the inlet 218 of the conduit 208 from interfacing or contacting the distal end of the chamber 216 (and blocking suction of the conduit 208). In some embodiments, the fluid permeable material 206 includes a bore sized to receive a portion of the conduit 208 including the inlet 218, with the bore terminating before extending all the way through the fluid permeable material 206. This bore, then prevents the inlet 218 from interfacing or contacting the distal end of the chamber 216.
[0041] The conduit 208 may include a flexible material such as plastic tubing (e.g, medical tubing). Such plastic tubing may include a thermoplastic elastomer, polyvinyl chloride, ethylene vinyl acetate, polytetrafluoroethylene, etc., tubing. In some embodiments, the conduit 208 may include silicone or latex.
[0042] In some embodiments, a fluid collection device according this disclosure may include a conduit formed from a fluid impermeable film and having a fluid permeable material disposed therein. Turning ahead in the drawings, FIG. 3A is a front view of a fluid collection device 300 and FIG. 3B is a cross-sectional view of the fluid collection device 300 of FIG. 3A, according to an embodiment. Unless otherwise noted, the fluid collection device 300 may include any aspect of the fluid collection device 200.
[0043] The fluid collection device 300 may include a conduit 308 formed from an additional fluid impermeable film and an additional fluid permeable material 326 positioned within the conduit 308 and configured to retain the conduit 308 in fluid communication with the chamber 216 when a vacuum pressure is applied to the conduit 308 (e.g.. prevent the conduit 308 from collapsing on itself under the vacuum pressure). The configurations of at least one, some, or all embodiments of the conduit 308 disclosed herein result in the technical effect of reducing the noise of negative-pressure fluid draw from the fluid collection device 300. The additional fluid permeable material 326 in the conduit 308 also may be generally capable of serving as a sound baffle.
[0044] The additional fluid impermeable film of the conduit 308 may include any film described above in relation to the fluid impermeable film 210. In some embodiments, the additional fluid impermeable film of the conduit 308 includes a panel of the fluid impermeable film folded over itself and heat-, solvent-, or adhesive-sealed along a seam to form the conduit 308. In some embodiments, the conduit 308 includes two panels of the additional fluid impermeable film heat, solvent, or adhesive-sealed together on two opposing longitudinal edges to form the conduit 308. In some embodiments, the additional fluid impermeable film of the conduit 308 includes a heat-shrinkable film that is heat shrunk around the additional fluid permeable material 326. In some embodiments, the additional fluid impermeable film of the conduit 308 may include a polyethylene film, a polyurethane film, a polymeric film, and/or a thermoplastic film. In some embodiments, the additional fluid impermeable film of the conduit 308 may include a thickness of about 1.5 mils to about 3.0 mils, about 1.5 mils to about 2.0 mils, about 1.75 mils to about 2.25 mils, about 2.0 mils to about 2.5 mils, about 2.25 mils to about 2.75 mils, about 2.5 mils to about 3.0 mils, less than about 3.0 mils, less than about 2.75 mils, less than about 2.5 mils, less than about 2.25 mils, less than about 2.0 mils, less than about 1.75 mils, less than about 1.5 mils, or less than about 1.25 mils.
[0045] The additional fluid permeable material 326 may be positioned in the conduit 308 such that a portion of the additional fluid permeable material 326 extends from the inlet
318 of the conduit 308 and into the chamber 216. Having a portion of the additional fluid permeable material 326 extend from the inlet 318 into the chamber 216 retains the inlet 318 in an open position when the conduit 308 is under negative pressure from the vacuum source. Accordingly, the conduit 308 and the additional fluid permeable material 326 may be configured such that the additional fluid permeable material 326 always extend at least to the inlet 318 and/or beyond the inlet 318. For example, the additional fluid impermeable film of the conduit 308 may be configured to form a tight fit around the additional fluid permeable material 326 such that the additional fluid permeable 326 material is not movable within the conduit 308. In some embodiments, the additional fluid impermeable film of the conduit 308 may be heat shrunk around the additional fluid permeable material
326 such that the additional fluid permeable material 326 is not movable within the conduit 308.
[0046] In some embodiments, the additional fluid permeable material 326 may have a cross-sectional thickness (shown in FIG. 3B) of about 0.25 cm to about 1.5 cm. about 0.25 cm to about 0.75 cm. about 0.50 cm to about 1.0 cm. about 0.75 cm to about 1.25 cm, about
1 .0 cm to about 1 .5 cm, about 0.25 cm, about 0.5 cm, about 0.75 cm, about 1.0 cm, about 1.25 cm, about 1.5 cm, less than about 1.5 cm, less than about 1.25 cm, less than about 1.0 cm, less than about 0.75 cm, or less than about 0.5 cm.
[0047] The additional fluid permeable material 326 may include any of the materials and characteristics described above in relation to the fluid permeable material 206 disposed in the chamber 216. For example, at least some (e.g, all) of the additional fluid permeable material 326 may include a non-woven polyester fiber material. In some embodiments, the fluid permeable material 206 in the chamber 216 includes a hydrophobic material. The additional fluid permeable material 326 may include both a hydrophilic region 326a extending outward from the inlet 318 into the chamber 216 and a hydrophobic region 326b positioned within the conduit 308. This configuration results in the technical effect of improved draining capabilities of the fluid collection device 300. The hydrophilic region 326a may be integrally formed with or otherwise secured to the hydrophobic region 326b. [0048] In some embodiments, the additional fluid permeable material 326 includes a non-linear configuration within the conduit 308. In some embodiments, the additional fluid permeable material includes one or more of longitudinal ridges 324, posts, and/or dimples 328 on a surface of the additional fluid permeable material 326. In these and other embodiments, the additional fluid impermeable film of the conduit 308 may be sealed around the additional fluid permeable material 326 and the longitudinal ridges 324, posts, and/or dimples 328 promote an open configuration of the conduit 308. Even with the one or more of longitudinal ridges 324. posts, and/or dimples 328 on a surface of the additional fluid permeable material 326, the side profile of the conduit 308 may be substantially planar and/or the conventional rounding of tubes may be absent from the conduit 308. [0049] The fluid collection device 300 also may include an adapter secured or securable to the conduit 308 at a predetermined distance from the fluid impermeable panel 210 and configured to secure to a tube or conduit that provides the negative pressure from the vacuum source for fluid removal from the fluid collection device 300.
[0050] Turning ahead in the drawings, FIG. 5A is a top isometric view of a portion of a fluid permeable material 526 of a conduit, according to an embodiment, and FIG. 5B is a side view of the portion of the fluid permeable matenal 526 of FIG. 5A. The fluid permeable material 526 may be used with the conduit 308 (e.g, the fluid permeable material 526 may replace the fluid permeable material 326 in the conduit 308). Only a portion of the fluid permeable material 526 is shown, and the fluid permeable material 526 may include any shape and/or configuration shown and/or described in relation to the fluid permeable material 326. Unless otherwise noted, the fluid permeable material 526 may include any aspect of the fluid permeable material 326, including but not limited to the materials, thicknesses, and/or features of the fluid permeable material 326. In some embodiments, the fluid permeable material 526 may be printed three-dimensionally. In some embodiments, the fluid permeable material 526 may include a thermoformed elastomer that is cast, embossed, thermoformed, or extruded.
[0051] The fluid permeable material 526 may include a substantially planar surface 525 having raised protuberances 528. The protuberances 528 may include posts that are rounded and/or have a circular profile. In some embodiments, at least some (e.g, all) of the protuberances 528 may be raised from the surface 525 about 1.5 mils to about 5.0 mils, about 1.5 mils to about 2.0 mils, about 1.75 mils to about 2.25 mils, about 2.0 mils to about 2.5 mils, about 2.25 mils to about 2.75 mils, about 2.5 mils to about 3.0 mils, about 2.75 mils to about 3.25 mils, about 3.0 mils to about 3.5 mils, about 3.25 mils to about 3.75 mils, about 3.5 mils to about 4.0 mils, about 3.75 mils to about 4.25 mils, about 4.0 mils to about 4.5 mils, about 4.25 mils to about 4.75 mils, or about 4.5 mils to about 5.0 mils. The fluid permeable material also may include an edge 524 raised from the surface 525 and defining a trough. When the fluid impermeable film of the conduit 308 is secured around the fluid permeable material 526, the raised edge 524 and/or the protuberances 528 result in the technical effect of maintaining a fluid path through the conduit 308, even when the conduit 308 is under a negative pressure. The raised edge 524 and/or the protuberances 528 also may reduce the sound of fluid flowing through the conduit 308 during use.
[0052] FIG. 4 is a flow diagram of a method 400 of manufacturing a fluid collection device, according to an embodiment. The method 400 may be performed to form any of the fluid collection devices 200, 300 described herein. In an embodiment, the method 400 includes an act 405 of securing a first panel of fluid impermeable film to a second panel of fluid impermeable film to form a fluid impermeable body including a distal region, a proximal region, a chamber positioned between the first panel and the second panel, and an opening in fluid communication with the chamber. The first panel may be positioned at least partially between the distal region and the proximal region and having a first proximal end, and the second panel may be positioned at least partially between the distal region and the proximal region and have a second proximal end spaced proximally from the first proximal end of the first panel. The method 400 also may include an act 410 of inserting a fluid permeable material into the chamber effective to space the first panel from the second panel around the chamber and retain the opening between the first panel and the second panel. The method 400 also may include an act 415 of securing a first portion of one or more porous materials to the first panel opposite to the second panel with the first portion of the one or more porous material extending distally from at least proximate to the first proximal end of the first panel. The method 400 also may include an act 420 of securing a second portion of the one or more porous materials to the second panel such that the second portion extends proximally from at least proximate to the first proximal end of the first panel and extends from the first panel to the second panel over the opening. The method also may include an act 425 of disposing an inlet of a conduit in the chamber with the conduit extending proximally from the fluid collection device. [0053] In some embodiments of the method 400, the first portion of the one more porous materials includes an absorbent material secured to the first panel opposite to the second panel and extending distally from at least proximate to the first proximal end of the first panel. In some embodiments of the method 400, the second portion of the one or more porous materials includes a wicking material extending proximally from at least proximate to the first proximal end of the first panel such that the wicking material extends over the opening. The wicking material may be positioned on the fluid collection device to contact a region of a user at least proximate to a urethra of the user. In these and other embodiments, the wicking material may extend proximally to the second proximal end of the second panel, and the conduit may be positioned between the wicking material and the second panel.
[0054] In some embodiments of the method 400, the fluid permeable material includes a non-woven polyester fiber material. The act 405 of securing a first panel of fluid impermeable film to a second panel of fluid impermeable film may include sealing the first panel to the second panel, according to an embodiment.
[0055] The method 400 may further comprise an act of inserting an additional fluid permeable material into the conduit. In these and other embodiments, the method 400 may further comprise an act of forming the conduit with an additional fluid impermeable film before inserting the additional fluid permeable material into the conduit. The additional fluid permeable material may retain the conduit in fluid communication with the chamber when a vacuum pressure is applied to the conduit. The additional fluid permeable material may extend from the inlet of the conduit and into the chamber, and at least some of the additional fluid permeable material includes anon-woven polyester fiber material. In some embodiments of the method 400, the fluid permeable material in the chamber includes a hydrophobic material and the additional fluid permeable material includes a hydrophilic region extend outward from the inlet into the chamber and a hydrophobic region positioned within the conduit.
[0056] In some embodiments of the method 400, the additional fluid permeable material includes a non-linear configuration and/or one or more of longitudinal ridges, posts, and/or dimples on a surface of the additional fluid permeable material. In some embodiments, the method 400 further comprises an act of heat shrinking the fluid impermeable around the additional fluid permeable material.
[0057] Acts of the method 400 are for illustrative purposes. For example, the acts of the method 400 may be performed in different orders, split into multiple acts, modified. supplemented, or combined.
[0058] As used herein, the term “about” or “substantially” refers to an allowable variance of the term modified by “about” by ±10% or ±5%. Further, the terms “less than,” “or less,” “greater than”, “more than,” or “or more” include as an endpoint, the value that is modified by the terms “less than,” “or less,” “greater than,” “more than,” or “or more.” [0059] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiment disclosed herein are for purposes of illustration and are not intended to be limiting.

Claims

CLAIMS What is claimed is:
1. A fluid collection device, comprising: a fluid impermeable film including a distal region, a proximal region, a first panel positioned at least partially between the distal region and the proximal region and having a first proximal end, and a second panel positioned at least partially between the distal region and the proximal region and having a second proximal end spaced proximally from the first proximal end of the first panel, the first panel and the second panel at least partially defining a chamber therebetween and an opening in fluid communication with the chamber; a fluid permeable material positioned within the chamber and configured to space the first panel from the second panel and retain the opening between the first panel and the second panel; one or more porous materials extending between the proximal region and the distal region, a first portion of the one or more porous materials being secured to the first panel opposite to the second panel and extending distally from at least proximate to the first proximal end of the first panel, and a second portion of the one or more porous materials extending proximally from at least proximate to the first proximal end of the first panel and secured to the second panel such that the second portion extends from the first panel to the second panel over the opening; and a conduit having an inlet positioned in the chamber and extending proximally from the fluid collection device.
2. The fluid collection device of claim 1, wherein: the first portion of the one more porous materials includes an absorbent material secured to the first panel opposite to the second panel and extending distally from at least proximate to the first proximal end of the first panel; and the second portion of the one or more porous materials includes a wicking material extending proximally from at least proximate to the first proximal end of the first panel such that the wicking material extends over the opening, the wicking material being positioned on the fluid collection device to contact a region of a user at least proximate to a urethra of the user.
3. The fluid collection device of claim 2, wherein the wicking material extends proximally to the second proximal end of the second panel, the conduit being positioned between the wicking material and the second panel.
4. The fluid collection device of any of claims 1 -3, wherein the fluid permeable material positioned in the chamber includes a non-woven polyester fiber material.
5. The fluid collection device of any of claims 1-4, wherein the first panel and the second panel of the fluid impermeable film are sealed directly together.
6. The fluid collection device of any of claims 1-5, wherein the conduit includes an additional fluid impermeable film and an additional fluid permeable material positioned within the conduit and configured to retain the conduit in fluid communication with the chamber when a vacuum pressure is applied to the conduit.
7. The fluid collection device of claim 6, wherein the additional fluid permeable material extends from the inlet of the conduit and into the chamber.
8. The fluid collection device of claim 6 or claim 7, wherein at least some of the additional fluid permeable material includes a non-woven polyester fiber material.
9. The fluid collection device of any of claims 6-8, wherein the fluid permeable material in the chamber includes a hydrophobic material and the additional fluid permeable material includes a hydrophilic region extending outward from the inlet into the chamber and a hydrophobic region positioned within the conduit.
10. The fluid collection device of any of claims 6-9, wherein the additional fluid permeable material includes a non-linear configuration.
11. The fluid collection device of any of claims 6-10, wherein the additional fluid permeable material includes one or more of longitudinal ridges, posts, and/or dimples on a surface of the additional fluid permeable material, and the additional fluid impermeable film is sealed around the additional fluid permeable material.
12. The fluid collection device of any of claims 6-11, wherein the additional fluid impermeable film includes a polymeric film that is heat shrunk around the additional fluid permeable material.
13. A fluid collection device, comprising: a fluid impermeable barrier defining a chamber and an opening in fluid communication with the chamber; a fluid permeable material positioned within the chamber and configured to space the fluid impermeable barrier and retain the opening in the fluid impermeable barrier, the fluid permeable material including a hydrophobic material; a conduit having an inlet positioned in the chamber and extend outward from the fluid impermeable barrier, wherein the conduit includes an additional fluid permeable material positioned within the conduit having a hydrophilic region extending outward from the inlet into the chamber and a hydrophobic region positioned within the conduit.
14. The fluid collection device of 13, wherein the conduit includes an additional fluid impermeable film and the additional fluid permeable material positioned within the conduit is configured to retain the conduit in fluid communication with the chamber when a vacuum pressure is applied to the conduit.
15. The fluid collection device of claim 13 or claim 14. wherein at least some of the additional fluid permeable material includes a non-woven polyester fiber material.
16. The fluid collection device of any of claims 13-15, wherein the additional fluid permeable material includes a non-linear configuration.
17. The fluid collection device of any of claims 13-16, wherein the additional fluid permeable material includes one or more of longitudinal ridges, posts, and/or dimples on a surface of the additional fluid permeable material, and the additional fluid impermeable film is sealed around the additional fluid permeable material.
18. The fluid collection device of any of claims 13-17, wherein the additional fluid impermeable film includes a polymeric film that is heat shrunk around the additional fluid permeable material.
19. The fluid collection device of any of claims 13-18, wherein the fluid permeable material positioned in the chamber includes a non-woven polyester fiber material.
20. The fluid collection device of any of claims 13-19, wherein: the fluid impermeable barrier includes a fluid impermeable film including a distal region, a proximal region, a first panel positioned at least partially between the distal region and the proximal region and having a first proximal end, and a second panel positioned at least partially between the distal region and the proximal region and having a second proximal end spaced proximally from the first proximal end of the first panel, the first panel and the second panel at least partially defining the chamber therebetween and the opening in fluid communication with the chamber; and the fluid permeable material is positioned within the chamber and configured to space the first panel from the second panel and retain the opening between the first panel and the second panel.
21. The fluid collection device of claim 20, further comprising: an absorbent material secured to the first panel opposite to the second panel and extending distally from at least proximate to the first proximal end of the first panel; and a wicking material extending proximally from at least proximate to the first proximal end of the first panel such that the wicking material extends over the opening, the wicking material being positioned on the fluid collection device to contact a region of a user at least proximate to a urethra of the user.
22. The fluid collection device of claim 21, wherein the wicking material extends proximally to the second proximal end of the second panel, the conduit being positioned between the wicking material and the second panel.
23. The fluid collection device of any of claims 20-22, wherein the first panel and the second panel of the fluid impermeable film are sealed directly together.
24. A fluid collection system, comprising: a fluid storage container configured to hold a fluid; the fluid collection device of any one of claims 1-23; and a vacuum source fluidly coupled to one or more of the fluid storage container or the fluid collection device via the conduit, the vacuum source configured to draw fluid from the fluid collection device via the conduit.
25. A method of manufacturing a fluid collection device, the method comprising: securing a first panel of fluid impermeable film to a second panel of fluid impermeable film to form a fluid impermeable body including a distal region, a proximal region, a chamber positioned between the first panel and the second panel, and an opening in fluid communication with the chamber, the first panel being positioned at least partially between the distal region and the proximal region and having a first proximal end, and the second panel being positioned at least partially between the distal region and the proximal region and having a second proximal end spaced proximally from the first proximal end of the first panel; inserting a fluid permeable material into the chamber effective to space the first panel from the second panel around the chamber and retain the opening between the first panel and the second panel; securing a first portion of one or more porous materials to the first panel opposite to the second panel with the first portion of the one or more porous material extending distally from at least proximate to the first proximal end of the first panel; securing a second portion of the one or more porous materials to the second panel such that the second portion extends proximally from at least proximate to the first proximal end of the first panel and extends from the first panel to the second panel over the opening; and disposing an inlet of a conduit in the chamber with the conduit extending proximally from the fluid collection device.
26. The method of claim 25, wherein: the first portion of the one more porous materials includes an absorbent material secured to the first panel opposite to the second panel and extending distally from at least proximate to the first proximal end of the first panel; and the second portion of the one or more porous materials includes a wicking material extending proximally from at least proximate to the first proximal end of the first panel such that the wicking material extends over the opening, the wicking material being positioned on the fluid collection device to contact a region of a user at least proximate to a urethra of the user.
27. The method of claim 26, wherein the wicking material extends proximally to the second proximal end of the second panel, the conduit being positioned between the wicking material and the second panel.
28. The method of any of claims 25-27, wherein the fluid permeable material includes a non-woven polyester fiber material.
29. The method of any of claims 25-28, wherein securing a first panel of fluid impermeable film to a second panel of fluid impermeable film includes sealing the first panel to the second panel.
30. The method of any of claims 25-29, further comprising inserting an additional fluid permeable material into the conduit.
31. The method of claim 30, further comprising forming the conduit with an additional fluid impermeable film before inserting the additional fluid permeable material into the conduit, wherein the additional fluid permeable material retains the conduit in fluid communication with the chamber when a vacuum pressure is applied to the conduit.
32. The method of claim 31, wherein the additional fluid permeable material extends from the inlet of the conduit and into the chamber.
33. The method of claim 31 or claim 32, wherein at least some of the additional fluid permeable material includes a non-woven polyester fiber material.
34. The method of any of claims 31-33, wherein the fluid permeable material in the chamber includes a hydrophobic material and the additional fluid permeable material includes a hydrophilic region extend outward from the inlet into the chamber and a hydrophobic region positioned within the conduit.
35. The method of any of claims 31-34, wherein the additional fluid permeable material includes a non-linear configuration.
36. The method of any of claims 31-35, wherein the additional fluid permeable material includes one or more of longitudinal ridges, posts, and/or dimples on a surface of the additional fluid permeable material.
37. The method of any of claims 31-36, further comprising heat shrinking the fluid impermeable around the additional fluid permeable material.
PCT/US2023/085516 2023-12-21 2023-12-21 Fluid collection devices including a fluid impermeable film and flat fluid permeable material disposed therein, and related systems and methods Pending WO2025136399A1 (en)

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2148126A (en) * 1983-10-26 1985-05-30 Nat Res Dev Incontinence appliances
US5911222A (en) * 1992-08-07 1999-06-15 Bristol-Myers Squibb Liquid removal system
WO2022086898A1 (en) * 2020-10-21 2022-04-28 Purewick Corporation Fluid collection assemblies including one or more leak prevention features
US20220287867A1 (en) * 2021-03-10 2022-09-15 Purewick Corporation Bodily waste and fluid collection with sacral pad
WO2022216776A1 (en) * 2021-04-09 2022-10-13 Purewick Corporation Conduits including at least one conduit porous material

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2148126A (en) * 1983-10-26 1985-05-30 Nat Res Dev Incontinence appliances
US5911222A (en) * 1992-08-07 1999-06-15 Bristol-Myers Squibb Liquid removal system
WO2022086898A1 (en) * 2020-10-21 2022-04-28 Purewick Corporation Fluid collection assemblies including one or more leak prevention features
US20220287867A1 (en) * 2021-03-10 2022-09-15 Purewick Corporation Bodily waste and fluid collection with sacral pad
WO2022216776A1 (en) * 2021-04-09 2022-10-13 Purewick Corporation Conduits including at least one conduit porous material

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