Fluid collection assemblies including at least one inflation device

Abstract

An example fluid collection assembly includes a fluid impermeable barrier. The fluid impermeable barrier defines a chamber, at least one opening permitting access to the chamber, and a fluid outlet configured to remove bodily fluids (e.g., urine or other bodily fluids) from the chamber. The fluid collection assembly also includes at least one porous material at least partially occupying the chamber. Further, the fluid collection assembly includes at least one inflation device attached to or integrally formed with the fluid impermeable barrier. The inflation device defines at least one inflation chamber that is configured to receive an inflation fluid (e.g., air, water, etc.). The inflation device is configured to increase a rigidity of at least a portion of the fluid collection assembly (e.g., at least a portion of the fluid impermeable barrier) when the inflation fluid at least partially occupies the inflation chamber.

Description

FLUID COLLECTION ASSEMBLIES INCLUDING AT LEAST ONE INFLATION DEVICEBACKGROUND

[0001] A person or animal may have limited or impaired mobility so typical urination processes are challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes bodily fluids collection is needed for monitoring purposes or clinical testing.

[0002] Urinary catheters, such as a Foley catheter, can address some of these circumstances, such as incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections. Additionally, bed pans, which are receptacles used for the toileting of bedridden individuals are sometimes used. However, bedpans can be prone to discomfort, spills, and other hygiene issues.SUMMARY

[0003] Embodiments disclosed herein are related to fluid collection assemblies including at least one inflation device, systems including the same, and methods of using the same. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier including at least one exterior surface and at least one inner surface. The at least one inner surface defines a chamber. The fluid impermeable barrier defines an opening and a fluid outlet. The fluid collection assembly also includes at least one porous material at least partially occupying the chamber. Further, the fluid collection assembly includes at least one inflation device attached to or integrally formed with the fluid impermeable barrier. The at least one inflation device defines at least one inflation chamber configured to receive an inflation fluid. The at least one inflation device is configured to increase a rigidity of at least a portion of the fluid collection assembly when the at least one inflation chamber is at least partially occupied by the inflation fluid. At least deflating the at least one inflation devices causes negligible shape change in the fluid collection assembly when the fluid collection assembly is resting on a surface.

[0004] In an embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid impermeable barrier including at least one exterior surface and at least one innersurface. The at least one inner surface defines a chamber. The fluid impermeable barrier defines an opening and a fluid outlet. The fluid collection assembly also includes at least one porous material at least partially occupying the chamber. Further, the fluid collection assembly includes at least one inflation device attached to or integrally formed with the fluid impermeable barrier. The at least one inflation device defines at least one inflation chamber configured to receive an inflation fluid. The at least one inflation device is configured to increase a rigidity of at least a portion of the fluid collection assembly when the at least one inflation chamber is at least partially occupied by the inflation fluid. At least deflating the at least one inflation devices causes negligible shape change in the fluid collection assembly when the fluid collection assembly is resting on a surface. The fluid collection system also includes a fluid storage container and a vacuum source. The chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other so that, when one or more bodily fluids are present in the chamber, a suction provided from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and deposits the bodily fluids in the fluid storage container.

[0005] In an embodiment, a method to use a fluid collection assembly is disclosed. The method includes positioning an opening of the fluid collection assembly adjacent to a urethral opening or positioning a penis through the opening. The fluid impermeable barrier includes a fluid impermeable barrier including at least one exterior surface and at least one inner surface. The at least one inner surface defines a chamber. The fluid impermeable barrier defines the opening and a fluid outlet. The fluid collection assembly also includes at least one porous material at least partially occupying the chamber. The method also includes inflating at least one inflation device attached to or integrally formed with the fluid impermeable barrier with an inflation fluid to increase the rigidity of the fluid collection assembly. The at least one inflation device defines at least one inflation chamber configured to receive an inflation fluid. The at least one inflation device is configured to increase a rigidity of at least a portion of the fluid collection assembly when the at least one inflation chamber is at least partially occupied by the inflation fluid. Inflating the at least one inflation devices causes a negligible shape change in the fluid collection assembly when the fluid collection assembly is resting on a surface.

[0006] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of thepresent 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

[0007] 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.

[0008] FIG. 1A is a top plan view of a fluid collection assembly, according to an embodiment.

[0009] FIGS. IB and 1C are cross-sectional views of the fluid collection assembly taken along planes 1B-1B and 1C-1C, respectively.

[0010] FIG. 2 is a top plan view of a fluid collection assembly, according to an embodiment.

[0011] FIG. 3 is a top plan view of a fluid collection assembly including an inflation device extending at a non-parallel angle relative to a longitudinal axis of the fluid impermeable barrier, according to an embodiment.

[0012] FIG. 4 is top plan view a fluid collection assembly, according to an embodiment.

[0013] FIG. 5 is a cross-sectional view of a fluid collection assembly including at least one inflation device disposed on the inner surface and a bottom panel of a fluid impermeable barrier, according to an embodiment.

[0014] FIG. 6A is a top plan view of a fluid collection assembly, according to an embodiment.

[0015] FIG. 6B is an example cross-sectional view of a portion of the fluid collection assembly taken along plane 6B-6B, according to an embodiment.

[0016] FIG. 6C is an example cross-sectional view of a portion of the fluid collection assembly taken along plane 6C-6C that is different than the example cross-sectional view shown in FIG. 6B, according to an embodiment.

[0017] FIG. 7 is a top plan view of a fluid collection assembly, according to an embodiment.

[0018] FIG. 8A is a top plan view of a fluid collection assembly, according to an embodiment.

[0019] FIG. 8B is a cross-sectional view of a collapsible pump that may be used with the fluid collection assembly, according to an embodiment.

[0020] FIG. 9 is a cross-sectional view of a portion of a fluid collection assembly, according to an embodiment.

[0021] FIG. 10 is a cross-sectional view of an inflation device, according to an embodiment.

[0022] FIG. 11 is a cross-sectional view of a male fluid collection assembly, according to an embodiment.

[0023] FIG. 12 is an isometric view of a female fluid collection assembly, according to an embodiment.

[0024] FIG. 13 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.DETAILED DESCRIPTION

[0025] Embodiments disclosed herein are related to fluid collection assemblies including at least one inflation device, systems including the same, and methods of using the same. An example fluid collection assembly includes a fluid impermeable barrier. The fluid impermeable barrier defines a chamber, at least one opening permitting access to the chamber, and a fluid outlet configured to remove bodily fluids (e.g., urine or other bodily fluids) from the chamber. The fluid collection assembly also includes at least one porous material at least partially occupying the chamber. Further, the fluid collection assembly includes at least one inflation device attached to or integrally formed with the fluid impermeable barrier. The inflation device defines at least one inflation chamber that is configured to receive an inflation fluid (e.g., air, gas, water, etc.). The inflation device is configured to increase a rigidity of at least a portion of the fluid collection assembly (e.g., at least a portion of the fluid impermeable barrier) when the inflation fluid at least partially occupies the inflation chamber.

[0026] During use, the fluid collection assembly may be positioned on an individual such that the opening receives a penis or is otherwise positioned adjacent to a urethral opening of the individual (e.g., positioned adjacent to a vaginal region or a buried penis). The individual may discharge bodily fluids from the urethral opening into the chamber. The bodily fluids may be received into the porous material and flow through the porous material towards the fluid outlet or an inlet of a conduit that extends through the fluid outlet. A suction may be provided to the chamber via the fluid outlet and / or the conduit. The suction may remove at least most of the bodily fluids from the chamber.

[0027] The fluid collection assemblies including the inflation device are an improvement over conventional fluid collection assemblies. At least some conventionalfluid collection assemblies are generally flexible (e.g. , flimsy) which allow the conventional fluid collection assemblies to conform to a shape of the anatomy of the user. However, the flexibility of the conventional fluid collection assemblies present several issues. For example, movement of the individual may cause the conventional fluid collection assemblies to fall between the legs of the individual or otherwise shift due to the flexibility thereof. Allowing the conventional fluid collection assemblies to fall between the legs or otherwise move may cause at least one of: patient discomfort, skin integrity issues (e.g., rashes), or bodily fluids to leak therefrom. Also, the flexibility of the conventional fluid collection assemblies may collapse or kink when an external pressure is applied thereto, for instance, when the conventional fluid collection assemblies fall between the legs of the individual and the legs are subsequently closed.

[0028] However, the inflation devices of the fluid collection assemblies disclosed herein allow at least the fluid impermeable barrier around the inflation devices to exhibit increased rigidity which, in turn, allows the fluid collection assembly to be more rigid than if the fluid collection assembly did not include the inflation device. The increased rigidity of the fluid impermeable barrier better allows the fluid collection assembly to maintain a shape thereof. The ability of the fluid collection assembly to maintain the shape thereof decreases the likelihood that the fluid collection assembly falls between the legs of the individual and inhibits the collapse or kinking of the fluid collection assembly when an external pressure is applied to the fluid collection assembly. The inflation device may also allow the fluid impermeable barrier to maintain some of the flexibility thereof such that the fluid collection assembly may still conform to the shape of the anatomy of the individual. In an embodiment, the rigidity of the fluid impermeable barrier provided by the inflation device may be controlled by adding or removing an inflation fluid from the inflation device. Controlling the rigidity of the fluid impermeable barrier with the inflation device allows rigidity of the fluid impermeable barrier to be selected based on particular situations and / or the particular individual using the fluid collection assembly, for example, based on the individual’s preference (e.g., what the individual finds most comfortable) or the expected amount of movement by the individual.

[0029] FIG. 1A is a top plan view of a fluid collection assembly 100, according to an embodiment. FIGS. IB and 1C are cross-sectional views of the fluid collection assembly 100 taken along planes 1B-1B and 1C-1C, respectively. The fluid collection assembly 100 includes a fluid impermeable barrier 102. The fluid impermeable barrier 102includes at least one outer surface 104 and at least one inner surface 106. The inner surface 106 of the fluid impermeable barrier 102 defines a chamber 108. The fluid impermeable barrier 102 also defines at least one opening 110 and a fluid outlet 112. The fluid collection assembly 100 includes at least one porous material 114 that is disposed in the chamber 108. The porous material 114 is configured to receive bodily fluids that enter the chamber 108 (e.g., urine discharged from a penis extending through the opening 110) and moves the bodily fluids towards the fluid outlet 112. The fluid collection assembly 100 also includes an inflation device 118 that is configured to affect the rigidity of the fluid collection assembly 100 e.g., affect the rigidity of the fluid impermeable barrier 102).

[0030] The fluid collection assembly 100 is an example of a male fluid collection assembly though, in some embodiments, the fluid collection assembly 100 may be used to receive bodily fluids from a female urethral opening. The fluid collection assembly 100 includes a sheath 120 and a base 122. The base 122 is configured to be attached (e.g., permanently attached to or configured to be permanently attached) to the sheath 120. The base 122 is also configured to be attached to the region about the urethral opening (e.g., penis) of the individual.

[0031] The sheath 120 includes a fluid impermeable barrier 102 that is at least partially formed from a top panel 124 and a bottom panel 126. The top panel 124 and the bottom panel 126 may be attached together (e.g., exhibits multi -piece construction) or integrally formed together (e.g. , exhibits single piece construction). In an embodiment, as illustrated, the top panel 124 and the bottom panel 126 are distinct sheets. The fluid impermeable barrier 102 also defines a chamber 108 between the top panel 124 and the bottom panel 126, an opening 110 at a proximal end region 128 of the sheath 120, and a fluid outlet 112 at a distal end region 130 of the sheath 120. In an embodiment, the fluid impermeable barrier 102 is formed from one or more additional structures instead of or in addition to the top panel 124 and / or the bottom panel 126.

[0032] The fluid impermeable barrier 102 at least partially defines a chamber 108 (e.g., interior region) and an opening 110. For example, the inner surface 106 of the fluid impermeable barrier 102 at least partially defines the chamber 108 within the fluid collection assembly 100. The fluid impermeable barrier 102 temporarily stores the bodily fluids in the chamber 108. The fluid impermeable barrier 102 may be formed of any suitable fluid impermeable material(s), such as a fluid impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, apolycarbonate, etc.), a metal film, natural rubber, another suitable material, any other fluid impermeable material disclosed herein, or combinations thereof. As such, the fluid impermeable barrier 102 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 102. In an example, the fluid impermeable barrier 102 may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier 102 may be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least an outer surface 104 of the fluid impermeable barrier 102 may be formed from a soft and / or smooth material, thereby reducing chaffing.

[0033] In an embodiment, at least one of the top panel 124 or the bottom panel 126 is formed from an at least partially transparent fluid impermeable material, such as polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. Forming at least one of the top panel 124 or the bottom panel 126 from an at least partially transparent fluid impermeable material allows a person (e.g., medical practitioner) to examine the penis. In some embodiments, both the top panel 124 and the bottom panel 126 are formed from an at least partially transparent fluid impermeable material. Selecting at least one of the top panel 124 or the bottom panel 126 to be formed from an at least partially transparent impermeable material allows the penis to be examined without detaching the entire fluid collection assembly 100 from the region about the penis. For example, the chamber 108 may include a penis receiving area 132 that is configured to receive the penis of the individual when the penis extends into the chamber 108. The penis receiving area 132 may be defined by at least the porous material 114 and at least a portion of the at least partially transparent material of the top panel 124 and / or the bottom panel 126. In other words, the porous material 114 is positioned in the chamber 108 such that the porous material 114 is not positioned between the penis and at least a portion of the transparent portion of the top panel 124 and / or bottom panel 126 when the penis is inserted into the chamber 108 through the opening 110. The porous material 114 is generally not transparent and, thus, the portion of the at least partially transparent material of the top panel 124 and / or the bottom panel 126 that defines the penis receiving area 132 forms a window which allows the person to view into the penis receiving area 132 and examine the penis.

[0034] The opening 110 defined by the fluid impermeable barrier 102 provides an ingress route for bodily fluids to enter the chamber 108 when the penis is a buried penis and allow the penis to enter the chamber 108 (e.g., the penis receiving area 132) when the penis is not buried. The opening 110 may be defined by the fluid impermeable barrier102 (e.g., an inner edge of the fluid impermeable barrier 102). For example, the opening 110 is formed in and extends through the fluid impermeable barrier 102 thereby enabling bodily fluids to enter the chamber 108 from outside of the fluid collection assembly 100.

[0035] The fluid impermeable barrier 102 defines the fluid outlet 112 sized to receive the conduit 134. The conduit 134 may be at least partially disposed in the chamber 108 or otherwise in fluid communication with the chamber 108 through the fluid outlet 112. The fluid outlet 112 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 134, thereby substantially preventing the bodily fluids from escaping the chamber 108. In an embodiment, the fluid outlet 112 may be formed from a portion of the top panel 124 and the bottom panel 126 that are not attached or integrally formed together. In such an embodiment, the fluid impermeable barrier 102 may not include a rigid structure exhibiting a rigidity that is greater than the portions of the fluid impermeable barrier 102 thereabout which may facilitate manufacturing of the fluid collection assembly 100 and may decrease the number of parts that are used to form the fluid collection assembly 100 and may decrease the time required to manufacture the fluid collection assembly 100. The lack of the cap may make securing the conduit 134 to the fluid outlet 1 12 using interference fit difficult, though it is noted, attaching the conduit 134 to the fluid outlet 112 may still be possible. As such, the conduit 134 may be attached to the fluid outlet 112 (e.g., to the top and bottom panels 124, 126) using an adhesive, a weld, or otherwise bonding the conduit 134 to the fluid outlet 112. Attaching the conduit 134 to the fluid outlet 112 may prevent leaks and may prevent the conduit 134 from inadvertently becoming detached from the fluid outlet 112. In an example, the conduit 134 may be attached to the fluid outlet 112 in the same manufacturing step that attaches the top and bottom panels 124, 126 together. In an embodiment, as shown, the fluid outlet 112 includes a rigid structure 135. The rigid structure 135 may be attached to the panels of the fluid impermeable barrier 102. The rigid structure 135 may facilitate attachment of the conduit 134 to the fluid outlet 112. For example, the rigid structure 135 may be configured to be received into the conduit 134 (e.g., form a male connector) or receive the conduit (e.g., form a female connector) and be secured to the conduit 134 via an interference fit.

[0036] In an embodiment, the porous material 114 may be configured to wick any bodily fluids away from the opening 110, thereby preventing the bodily fluids from escaping the chamber 108. The porous material 114 may direct the bodily fluids to one ormore selected regions of the chamber 108, such as away from the penis and towards the fluid outlet 112.

[0037] The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and / or “wicking.” Such “wicking” and / or “permeable” properties may not include absorption of the bodily fluids into at least a portion of the porous material 114, such as not include adsorption of the bodily fluids into the fluid permeable support. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the material 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 porous material 114 (e.g., absorbency), such as less than about 30 wt% of the dry weight of the porous material 114, 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 porous material 114. The porous material 114 may also wick the bodily fluids generally towards an interior of the chamber 108, as discussed in more detail below. In an embodiment, the porous material 114 may include at least one absorbent or adsorbent material.

[0038] The porous material 114 may be formed from any of the porous materials disclosed herein. In an example, the porous material 114 may be formed from a single layer, two layers e.g. , a fluid permeable membrane extending across the opening 110 and a fluid permeable support since the fluid permeable membrane may be formed from a relatively foldable, flimsy, or otherwise easily deformable material), or three or more layers. In an example, the porous material 114 may be formed from a nonwoven material or a woven material (e.g., spun nylon fibers). In an example, the porous material 114 may include at least one material exhibiting substantially no absorption or at least one absorbent or adsorbent material.

[0039] In an embodiment, the porous material 114 may be a sheet. Forming the porous material 114 as a sheet may facilitate the manufacturing of the fluid collection assembly 100. For example, forming the porous material 114 as a sheet allows the top panel 124, the bottom panel 126, and the porous material 114 to each be sheets. During the manufacturing of the fluid collection assembly 100, the top panel 124, the bottom panel 126, and the porous material 114 may be stacked and then attached to each other inthe same manufacturing step. For instance, the porous material 114 may exhibit a shape that is the same size or, more preferably, slightly smaller than the size of the top panel 124 and the bottom panel 126. As such, attaching the top panel 124 and the bottom panel 126 together along the outer edges thereof may also attach the porous material 114 to the top panel 124 and the bottom panel 126. The porous material 114 may be slightly smaller than the top panel 124 and the bottom panel 126 such that the top panel 124 and / or the bottom panel 126 extend around the porous material 114 such that the porous material 114 does not form a passageway through the fluid impermeable barrier 102 through which the bodily fluids may leak. Also, attaching the porous material 114 to the top panel 124 and / or the bottom panel 126 may prevent the porous material 114 from significantly moving in the chamber 108, such as preventing the porous material 114 from bunching together near the fluid outlet 112. In an example, the porous material 114 may be attached to the top panel 124 or the bottom panel 126 (e.g., via an adhesive) before or after attaching the top panel 124 to the bottom panel 126. In an example, the porous material 114 may merely be disposed in the chamber 108 without attaching the porous material 114 to at least one of the top panel 124 or the bottom panel 126. In an embodiment, the porous material 1 14 may exhibit shapes other than a sheet, such as a hollow generally cylindrical shape.

[0040] In an embodiment, the porous material 114 may include the fluid permeable membrane disposed in the chamber 108. The fluid permeable membrane may cover at least a portion (e.g., all) of the opening 110. The fluid permeable membrane may be composed to wick the bodily fluids away from the opening 110, thereby preventing the bodily fluids from escaping the chamber 108.

[0041] In an embodiment, the fluid permeable membrane may include any material that may wick the bodily fluids. For example, the fluid permeable membrane may include fabric, such as a gauze (e.g., a silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a nonwoven material, or any of the other porous materials disclosed herein. Forming the fluid permeable membrane from gauze, soft fabric, and / or smooth fabric may reduce chaffing caused by the fluid collection assembly 100.

[0042] The fluid collection assembly 100 may include the fluid permeable support disposed in the chamber 108. The fluid permeable support is configured to support the fluid permeable membrane since the fluid permeable membrane may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the fluid permeable support may be positioned such that the fluid permeable membrane isdisposed between the fluid permeable support and the fluid impermeable barrier 102. As such, the fluid permeable support may support and maintain the position of the fluid permeable membrane. The fluid permeable support may include any material that may wick, absorb, adsorb, or otherwise allow fluid transport of the bodily fluids, such as any of the fluid permeable membrane materials disclosed herein above. For example, the fluid permeable membrane material(s) may be utilized in a more dense or rigid form than in the fluid permeable membrane when used as the fluid permeable support. The fluid permeable support may be formed from any fluid permeable material that is less deformable than the fluid permeable membrane. For example, the fluid permeable support may include a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam, such as spun nylon fiber. In some examples, the fluid permeable support may include a nonwoven material. In some examples, the fluid permeable support may be formed from a natural material, such as cotton, wool, silk, or combinations thereof. In such examples, the material may have a coating to prevent or limit absorption of fluid into the material, such as a water repellent coating. In some examples, the fluid permeable support may be formed from fabric, felt, gauze, or combinations thereof.

[0043] In some examples, the fluid permeable membrane may be optional. For example, the porous material 114 may include only the fluid permeable support. In some examples, the fluid permeable support may be optionally omitted from the fluid collection assembly 100. For example, the porous material 114 may only include the fluid permeable membrane.

[0044] Other examples of porous materials that may be included in fluid collection assembly 100 are disclosed in PCT International Application No. PCT / US2022 / 011281 filed on January 5, 2022; PCT International Application No. PCT / US2022 / 042719 filed on September 7, 2022; PCT International Application No. PCT / US2022 / 042725 filed on September 7, 2022; PCT International Application No. PCT / US2022 / 015418 filed on February 7, 2022; PCT Patent Application No. PCT / US2021 / 039866 filed on June 30, 2021; and PCT International Application No. PCT / US2022 / 015420 filed on February 7, 2022, the disclosures of each of which are incorporated herein, in their entirety, by this reference.

[0045] In an embodiment, at least a portion of the porous material 114 (e.g. , one or more of the fluid permeable membrane or, more preferably, the fluid permeable support) may be hydrophobic. The porous material 114 may be hydrophobic when the porousmaterial 114 exhibits a contact angle with water (a major constituent of bodily fluids) that is greater than about 90°, such as in ranges of about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 175°, or about 150° to about 180°. The hydrophobicity of the porous material 114 may limit absorption, adsorption, and solubility of the bodily fluids in the porous material 114 thereby decreasing the amount of bodily fluids held in the porous material 114. In an embodiment, at least a portion of the porous material 114 is hydrophobic or hydrophilic. In an embodiment, the fluid permeable support is more hydrophobic (e.g., exhibits a larger contact angle with water) than the fluid permeable membrane. The lower hydrophobicity of the fluid permeable membrane may help the porous material 114 receive the bodily fluids from the urethral opening while the hydrophobicity of the fluid permeable support limits the bodily fluids that are retained in the porous material 114.

[0046] Generally, the sheath 120 is substantially flat when the penis is not in the penis receiving area 132 and the sheath 120 is resting on a flat surface. The sheath 120 is substantially flat because the fluid impermeable barrier 102 is formed from the top panel 124 and the bottom panel 126 instead of a generally tubular fluid impermeable barrier. Further, as previously discussed, the porous material 1 14 may be a sheet, which also causes the sheath 120 to be substantially flat. The sheath 120 may also be substantially flat because the fluid collection assembly 100 may not include relatively rigid rings or caps that exhibit a rigidity that is greater than the portions of the fluid impermeable barrier 102 thereabout since such rings and caps may inhibit the sheath 120 being substantially flat. It is noted that the sheath 120 is described as being substantially flat because at least one of the porous material 114 may cause a slight bulge to form in the sheath 120 depending on the thickness of the porous material 114, the fluid outlet 112 and / or conduit 134 may cause a bulge thereabout, or the base 122 may pull on portions of the sheath 120 thereabout. It is also noted that the sheath 120 may also be compliant and, as such, the sheath 120 may not be substantially flat during use since, during use, the sheath 120 may rest on a non-flat surface (e.g., may rest on the testicles, the perineum, and / or between the thighs) and the sheath 120 may conform to the surface of these shapes.

[0047] The ability of the sheath 120 to be substantially flat when the penis is not in the penis receiving area 132 and the sheath 120 is resting on a flat surface allows the fluid collection assembly 100 to be used with a buried and a non-buried penis. For example, when the fluid collection assembly 100 is being used with a buried penis, the penis doesnot extend into the penis receiving area 132 which causes the sheath 120 to lie relatively flat across the aperture 160 of the base 122. When the sheath 120 lies relatively flat across the aperture 160, the porous material 114 extends across the opening 110 and the aperture 160 and is in close proximity to the buried penis. As such, the porous material 114 prevents or inhibits pooling of bodily fluids discharged from the buried penis against the skin of the individual since the porous material 114 will receive and remove at least a significant portion of the bodily fluids that would otherwise pool against the skin of the individual. Thus, the skin of the individual remains dry thereby improving comfort of using the fluid collection assembly 100 and preventing skin degradation. However, unlike other conventional fluid collection assemblies that are configured to be used with buried penises, the fluid collection assembly 100 may still be used with a non-buried penis since the non-buried penis can still be received into the penis receiving area 132, even when the penis is fully erect. Additionally, the ability of the sheath 120 to be substantially flat allows the fluid collection assembly 100 to be used more discretely than if the sheath 120 was not substantially flat thereby avoiding possibly embarrassing scenarios.

[0048] When the sheath 120 is substantially flat, the porous material 1 14 occupies substantially all of the chamber 108 and the penis receiving area 132 is collapsed (shown as being non-collapsed in FIGS. IB and 1C for illustrative purposes to show the penis receiving area 132). In other words, the sheath 120 may not define a region that is constantly unoccupied by the porous material 114. When the porous material 114 occupies substantially all of the chamber 108, the bodily fluids discharged into the chamber 108 are unlikely to pool for significant periods of time since pooling of the bodily fluids may cause sanitation issues, cause an odor, and / or may cause the skin of the individual to remain in contact with the bodily fluids which may cause discomfort and skin degradation.

[0049] As previously discussed, the top panel 124, the bottom panel 126, and the porous material 114 may be selected to be relatively flexible. The top panel 124, the bottom panel 126, and the porous material 114 are relatively flexible when the top panel 124, the bottom panel 126, and the porous material 114, respectively, are unable to maintain their shape when unsupported. The flexibility of the top panel 124, the bottom panel 126, and the porous material 114 may allow the sheath 120 to be substantially flat, as discussed above. The flexibility of the top panel 124, the bottom panel 126, and the porous material 114 may also allow the sheath 120 to conform to the shape of the peniseven when the size and shape of the penis changes (e.g., becomes erect) and to minimize any unoccupied spaces in the chamber 108 in which bodily fluids may pool.

[0050] The porous material 114 may at least substantially completely fill the portions of the chamber 108 that are not occupied by the conduit 134. In some examples, the porous material 114 may not substantially completely fill the portions of the chamber 108 that are not occupied by the conduit 134. In such an example, the fluid collection assembly 100 includes the reservoir 136 disposed in the chamber 108.

[0051] The reservoir 136 is a substantially unoccupied portion of the chamber 108. The reservoir 136 may be defined between the fluid impermeable barrier 102 and one or both of the fluid permeable membrane and fluid permeable support. The bodily fluids that are in the chamber 108 may flow through the fluid permeable membrane and / or fluid permeable support to the reservoir 136. The reservoir 136 may retain of the bodily fluids therein.

[0052] The bodily fluids that are in the chamber 108 may flow through the fluid permeable membrane and / or fluid permeable support to the reservoir 136. The fluid impermeable barrier 102 may retain the bodily fluids in the reservoir 136. While depicted in the distal end region 130, the reservoir 136 may be located in any portion of the chamber 108 such as the proximal end region 128. The reservoir 136 may be located in a portion of the chamber 108 that is designed to be located in a gravimetrically low point of the fluid collection assembly when the fluid collection assembly is worn.

[0053] In some examples (not shown), the fluid collection assembly 100 may include multiple reservoirs, such as a first reservoir that is located at the portion of the chamber 108 closest to the inlet of the conduit 134 (e.g., distal end region 130) and a second reservoir that is located at the portion of the chamber 108 that is at or near proximal end region 128. In another example, the fluid permeable support is spaced from at least a portion of the conduit 134, and the reservoir 136 may be the space between the fluid permeable support and the conduit 134.

[0054] As previously discussed, a suction is applied to the chamber 108 via the fluid outlet 112. In an embodiment, the fluid collection assembly 100 may include one or more vents. The vents may include one or more holes 138 extending through the fluid impermeable barrier 102. For example, the top panel 124 of the fluid impermeable barrier 102 may define the holes 138. The holes 138 allow air to flow from an exterior of the fluid collection assembly 100 into the chamber 108 and through the chamber 108 to the fluid outlet 112 responsive to the suction being applied to the chamber 108. Such airflow may allow the pressure within the chamber 108 to be substantially at atmospheric pressure thereby minimizing patient discomfort (e.g. , preventing hickies on the individual’s penis caused by the suction). The air flow may also facilitate flow of the bodily fluids through the chamber 108. For example, the air flow through the chamber 108 may push the bodily fluids towards the fluid outlet 112. In an example, the vents also include an air permeable and fluid impermeable material 140 e.g., a porous hydrophobic material, such as a porous polytetrafluoroethylene membrane) extending across the holes 138 to prevent or at least inhibit leakage of the bodily fluids from the chamber 108 via the vents.

[0055] The vents may be positioned on the fluid collection assembly 100 to allow air flow through substantially all of the chamber 108. In an embodiment, the vents may include a proximal vent 142. The proximal vent 142 may be positioned in the proximal end region 128. The proximal vent 142 allows air to flow through substantially all of a length of the chamber 108. The proximal vent 142 may exhibit a longitudinal shape that extends from or near a lateral edge 158 of the fluid impermeable barrier 102 to an opposing lateral edge 158 of the fluid impermeable barrier 102 thereby inhibiting pooling of bodily fluids in the corners of the chamber 108 within the proximal end region 128. In an embodiment, the vents may include one or more lateral vents 144 positioned adjacent to the lateral edges 158 of the fluid impermeable barrier 102. The lateral vents 144 may be positioned in the distal end region 130 or, as shown, in an intermediate location between the proximal and distal end regions 128, 130. The lateral vents 144 promote air flow through the lateral portions of the chamber 108. For example, the air flow caused by the proximal vent 142 may generally flow in a straight line between the proximal vent 142 and the fluid outlet 112. In other words, the proximal vent 142 may not cause significant air flow through the lateral portions of the chamber 108. The lateral vents 144 remedy this issue by facilitating air flow through the lateral portions of the chamber 108.

[0056] As previously discussed, the fluid collection assembly 100 includes at least one inflation device 118. The inflation device 118 includes a bladder 146. The bladder 146 includes one or more walls 148 that at least partially define at least one inflation chamber 150. The inflation chamber 150 includes at least one inflation fluid therein. The inflation fluid in the inflation chamber 150 causes the inflation device 118 to exhibit a rigidity that is greater than if the inflation fluid were not in the inflation chamber 150. The increased rigidity of the inflation device 118 causes the inflation device 118 to increase the rigidity of at least a portion of the fluid impermeable barrier 102 thereabout.The increased rigidity of the fluid impermeable barrier 102 allows the fluid collection assembly 100 to maintain a shape thereof or exhibit any of the other benefits disclosed herein. The inflation device 118 may increase the rigidity of the fluid collection assembly 100 while causing, at most, negligible shape change in the fluid collection assembly. For example, when the inflation device 118 is resting on a surface (e.g., flat surface), the inflation device 118 may cause at most negligible shape changes in the fluid collection assembly when the inflation device 118 is attached to the fluid impermeable barrier 102 or the inflation device 118 is deflated (e.g., popped). As used herein, negligible shape changes refers to no shape changes or shape changes that do not cause the fluid impermeable barrier 102 to exhibit a shape that is substantially different than the shape of the surface. Examples of negligible shape changes may include one or more of localized curvatures causes by inherent curvature of the bladder 146 or shape changes that do not cause the fluid collection assembly 100 to exhibit a shape that corresponds to the vaginal region and / or perineum of the individual.

[0057] In an embodiment, the inflation device 118 may increase the rigidity of at least a portion of the fluid collection assembly 100 by about 10 % or more, about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, about 80% or more, about 100% or more, about 125% or more, about 150% or more, about 175% or more, about 200% or more, about 250% or more, about 300% or more, about 400% or more, about 500% or more, about 600% or more, about 800% or more, about 1000% or more, or in ranges of about 10% to about 30%, about 20% or to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 80%, about 60% to about 100%, about 80% to about 125%, about 100% to about 150%, about 125% to about 175%, about 150% to about 200%, about 175% to about 250%, about 200% to about 300%, about 250% to about 400%, about 300% to about 500%, about 400% to about 600%, about 500% to about 800%, or about 600% to about 1000%. In an embodiment, the inflation device 188 may increase the rigidity of at least a portion the fluid collection assembly 100 such that the at least a portion of the fluid collection assembly 100 substantially maintains a shape thereof regardless if the fluid collection assembly 100 is resting on a surface or gripped on the proximal or distal ends 128, 130 thereof.

[0058] The walls 148 are formed from a material that is substantially impermeable to the inflation fluid (e.g., substantially impermeable to a gas and / or a liquid) which allows the bladder 146 to retain the inflation fluids without leaks. The walls 148 may also beformed from a flexible material. The flexible material of the walls 148 allows the bladder 146 to stretch as needed. For example, the walls 148 may need to stretch when a quantity of inflations fluids disposed therein is greater than a relaxed volume of the inflation chamber 150 (e.g., the maximum volume of the inflation chamber 150 when the pressure therein is equal to atmospheric pressure) or when the inflation device 118 is partially bent (e.g., as the individual moves). Examples of materials that may form the walls 148 of the bladder 146 include silicone, rubber, latex, polychloroprene, nylon fabric, polypropylene, polyvinyl chloride, nitrile rubber, other suitable polymers, a metal foil, a composite, or combinations thereof. It is noted that the walls 148 may contact the patient and be formed from a biocompatible material. In an embodiment, the walls 148 are configured to stretch (e.g. , elastically or plastically stretch) so the walls 148 remain taut.

[0059] The inflation device 118 may include any suitable number of bladders 146. In an example, as shown, the inflation device 118 includes two bladders 146. The two bladders 146 allow the inflation device 118 to increase the rigidity of two different portions of the fluid impermeable barrier 102, such as the portions of the fluid impermeable barrier 102 adjacent to the two bladders 146. The two bladders 146 may also increase the rigidity of the fluid impermeable barrier 102 therebetween when the two bladders 146 are connected together by at least one component exhibiting a rigidity that is greater than the remainder of the fluid collection assembly 100 (e.g. , by the connector 152 or rigid wire or plate extending between the two bladders 146). In an embodiment, the inflation device 118 may include a single bladder 146 or three or more bladders 146.

[0060] In an embodiment, as shown, at least two of the bladders 146 are in fluid communication with each other. The bladders 146 are in fluid communication with each other when the inflation fluids may flow from the inflation chamber 150 defined by one bladder 146 to the inflation chamber 150 of another chamber 150. For example, the bladders 146 may be in fluid communication with each other when at least one connector 152 extends between the bladders 146. The connector 152 includes one or more walls 154 that at least a portion define a passageway 156 that extends between at least two bladders 146. The walls 154 may completely define the passageway 156 or, as shown, may define the passageway 156 with the fluid impermeable barrier 102. The connector 152 may be distinguishable from the bladders 146 because at least one of the connector 152 at least one of exhibits a width that is less than a width of the bladder 146 (as shown), is formed of a material that is different than the bladders 146, or the connector 152 increases the rigidity of the rest of the fluid collection assembly 100 less than the bladders146 (e.g., the walls 154 of the connector 152 are more elastic than the walls 148 of the bladders 146). The connector 152 may partially maintain the position and distance between the bladders 146 thereby allowing the fluid impermeable barrier 102 between the bladders 146 to be rigid, as previously discussed. The connector 152 also decreases the likelihood that a large external compressive applied to one bladder 146 e.g., caused by the individual moving) ruptures the bladder 146 since inflation fluids may flow from the compressed bladder 146 to an uncompressed bladder 146. In an embodiment, the connector 152 is omitted from the inflation device 118 such that each bladder 146 is not in fluid communication with another bladder 146.

[0061] In an embodiment, as shown, the inflation device 118 may be disposed on an outer surface 104 of the fluid impermeable barrier 102. Disposing the inflation device 118 on the outer surface 104 may facilitate assembly of the fluid collection assembly 100 since the inflation device 118 may be attached to the fluid impermeable barrier 102 after fluid impermeable barrier 102 is fully assembled. However, disposing the inflation device 118 on the outer surface 104 of the fluid impermeable barrier 102 may make it easier for the individual to feel the inflation device 118 which may make the fluid collection assembly 100 more uncomfortable to wear than if the inflation device 1 18 is disposed on an inner surface 106 (as shown in FIG. 5). Disposing the inflation device 118 on the outer surface 104 may also increase the likelihood that the inflation device 118 is inadvertently popped, such as while zipping up the individual’s pants.

[0062] In an embodiment, as shown, the inflation device 118 may be disposed on the top panel 124 (e.g., a top layer of the fluid impermeable barrier 102). During use, the bottom panel 126 of the fluid impermeable barrier 102 may contact the skin of the individual. In other words, the top panel 124 may be spaced from the skin of the individual by the bottom panel 126 and the porous material 114. As such, disposing the inflation device 118 on the top panel 124 causes the inflation device 118 to be less likely felt by the individual thereby minimizing any discomfort caused by the inflation device 118 than if the inflation device 118 is disposed on the bottom panel 126. Disposing the inflation device 118 on the top panel 124 also prevents the inflation device 118 from affecting the transparency of the bottom panel 126 when the bottom panel 126 is used to examine the individual’ s penis, as previously discussed.

[0063] At least a portion of the inflation device 118 (e.g., the bladder 146) is at least partially disposed along or adjacent (e.g., within 5 mm of) to the lateral edges 158 of the fluid impermeable barrier 102. Disposing the inflation device along the lateral edges 158prevents or minimizes the percentage of the fluid impermeable barrier 102 that extend laterally outwardly from the inflation device 118. For example, portions of the fluid impermeable barrier 102 that extend laterally outwardly from the inflation device 118 may droop during use. Bodily fluids that enter portions of the chamber 108 defined by such drooped portions of the fluid impermeable barrier 102 are likely to pool thereby increasing the moisture in the chamber 108 which may cause discomfort to the individual and cause unsanitary conditions to develop within the chamber 108. However, disposing the inflation device 118 along or adjacent to the lateral edges 158 prevents or at least inhibits such pooling of bodily fluids.

[0064] In an embodiment, the inflation device 118 (e.g., the bladder 146) may only extend along a portion of the lateral edges 158. In an example, the inflation device 118 may extend from or near the distal end region 126 to or near the lateral vent 144. In such an example, the inflation device 118 extends along the lateral edge 158 while also allowing the lateral vent 144 to be adjacent to the lateral edge 158. In an example, the portions of the fluid impermeable barrier 102 at the proximal end region 124 and between the opening 110 and the lateral edge 158 are likely to be supported by the region of the individual about the penis such that such portions of the fluid impermeable barrier 102 are unlikely to fall between the legs of the individual. As such, in such an example, the inflation device 118 may extend along the lateral edge 158 to or near such portions of the fluid impermeable barrier 102 since such portions may not need the increased rigidity provided by the inflation device 118.

[0065] The inflation device 118 and the bladders 146 thereof may exhibit any suitable shape. In an embodiment, as previously discussed, at least a portion of the inflation device 118 may extend along or adjacent to the lateral edge 158. In such an embodiment, at least a portion of the inflation device 118 may exhibit a shape that conforms to the shape of the lateral edge 158. Such shapes may include a generally U-like shape (as shown) when the inflation device 118 extends along both lateral edges 158, a generally J- like shape when the inflation device 118 extends along one lateral edge 158, a generally linear shape when the lateral edge 158 extends in a generally linear manner, or any other shape that corresponds to the shape of the lateral edge(s) 158. In an embodiment, the fluid impermeable barrier 102 may exhibit a longitudinal (e.g., central) axis and at least a portion of the inflation device 118 may exhibit a shape that is generally parallel to the longitudinal axis of the fluid impermeable barrier 102. That is, at least a portion of the inflation device 118 may extend generally parallel to the longitudinal axis of the fluidimpermeable barrier 102. The inflation device 118 extending parallel to the longitudinal axis may minimize the length and size of the inflation device 118 while maximizing the length of the fluid impermeable barrier 102 that is supported by the inflation device 118.

[0066] The at least one inflation fluid present in the inflation chamber 150 may include any suitable fluid, such as any suitable liquid or any suitable gas. In an embodiment, the inflation fluids include a generally regarded as safe (“GRAS”) material which may decrease health risks caused by inadvertently exposing the individual to the inflation fluids. Examples of GRAS materials that may form the inflation fluids includes water, saline solution, alcohol solution, atmospheric air, nitrogen, any other GRAS material, or combinations thereof.

[0067] The inflation device 118 does not include a port through which the inflation fluids may be inserted into or removed from the inflation chamber 150. In other words, inflation fluids may not be inserted into or removed from the inflation chamber 150 without damaging the inflation device 118. As such, the inflation device 118 is provided in an inflated state and remains in the inflated state. Providing the inflation device 118 in an inflated state makes using the inflation device 118 simpler since there is no need to at least partially inflate or deflate the inflation device 1 18. Instead, the inflation device 1 18 may be provided with sufficient inflation fluids that the inflation device 118 increases the rigidity of at least a portion of the rest of the fluid impermeable barrier 102. The inflation device 118 without a port may also facilitate manufacturing of the inflation device 118 since no port needs to be formed or a component (e.g., valve, pump, etc.) attached to the port. It is noted that the inflation fluids may be disposed in the inflation chamber 150 during manufacturing using any suitable technique, such as using a hole to insert the inflation fluids into the inflation chamber 150 and (depending on the size of the hole and the hydrophobicity of the walls 148) the hole may be subsequently patched over. It is also noted that the rigidity provided by the inflation device 118 to the rest of the fluid collection assembly 100 may be controlled by popping or otherwise forming a hole in the walls 148 thereby allowing the inflation fluid to leave the inflation chamber 150.

[0068] As previously discussed, the fluid collection assembly 100 includes a base 122 that is configured to be attached to the sheath 120. For example, the base 122 is configured to be permanently attached to the sheath 120. The base 122 is configured to be permanently attached to the sheath 120 when, for example, the fluid collection assembly 100 is provided with the base 122 permanently attached to the sheath 120 or the base 122 is provided without being permanently attached to the sheath 120 but isconfigured to be permanently attached to the sheath 120 at some point in the future. Permanently attached means that the sheath 120 cannot be detached from the base 122 without damaging at least one of the sheath 120 or the base 122, using a blade to separate the sheath 120 from the base 122, and / or using chemicals to dissolve the adhesive that attaches the sheath 120 from the base 122. The base 122 may be permanently attached to the sheath 120 using an adhesive, sewing, heat sealing, RF welding, or US welding. In an embodiment, the base 122 is configured to be reversibly attached to the sheath 120. In an embodiment, the base 122 is integrally formed with the sheath 120.

[0069] The base 122 includes an aperture 160. The base 122 is permanently attached to the distal end region 130 of the sheath 120 such that the aperture 160 is aligned with the opening 110.

[0070] The base 122 is sized, shaped, and made of a material to be coupled to the skin that surrounds the penis (e.g., mons pubis, thighs, testicles, and / or perineum) and have the penis disposed therethrough. For example, the base 122 may define an aperture 160 configured to have the penis positioned therethrough. In an example, the base 122 may exhibit the general shape or contours of the skin surface that the base 122 is configured to be coupled with. The base 122 may be flexible, thereby allowing the base 122 to conform to any shape of the skin surface and mitigate the base 122 pulling the on skin surface. The base 122 may extend laterally past the sheath 120 thereby increasing the surface area of the skin of the individual to which the fluid collection assembly 100 may be attached compared to a substantially similar fluid collection assembly 100 that did not include a base.

[0071] The fluid collection assembly 100 may include a conduit 134 (shown in FIG. IB). The conduit 134 is in fluid communication with the chamber 108. For example, as shown, the conduit 134 may be attached to the rigid structure of the fluid. The conduit 134 may be used to remove the bodily fluids from the chamber 108. The conduit 134 includes at least one wall defining an inlet, an outlet (not shown) downstream from the inlet, and a passageway. The outlet of the conduit 134 may be operably coupled (e.g. , directly or indirectly) to a vacuum source, such as a vacuum pump for withdrawing fluid from the chamber 108 through the conduit 134. For example, the conduit 134 may extend into the fluid impermeable barrier 102 from the proximal end region 128 and may extend to the distal end region 130 to a point proximate to the reservoir 136 therein such that the inlet is in fluid communication with the reservoir 136. The conduit 134 fluidly couplesthe chamber 108 with the fluid storage container (not shown) or the vacuum source (not shown).

[0072] The inlet of the conduit 134 may be located near the distal end region 130 of the sheath 120 which is expected to be the gravimetric ally low point of the chamber 108 when worn by an individual. Locating the inlet at or near the distal end region 130 of the sheath 120 enables the conduit 134 to receive more of the bodily fluids than if the inlet of the conduit 134 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors).

[0073] The inflation device 118 illustrated in FIGS. 1A-1C is merely one example of the orientations and positions that the inflation devices disclosed herein may exhibit. FIGS. 2-5 illustrate other examples of the orientations and positions that the inflation devices disclosed herein may exhibit. FIG. 2 is a top plan view of a fluid collection assembly 200, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 200 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 200 includes a fluid impermeable barrier 202 extending from a proximal end region 228 to a distal end region 230. The fluid impermeable barrier 202 also includes lateral edges 258 and, optionally, a proximal vent 242 and at least one lateral vent 244. The fluid collection assembly 200 further includes at least one inflation device 218.

[0074] The inflation device 218 extends from the proximal end region 228 to the distal end region 230. For example, the inflation device 218 extends along or adjacent to substantially all of the lateral edge 258 of the fluid impermeable barrier 202. As such, the inflation device 218 may increase the rigidity of substantially all of the fluid impermeable barrier 202. Increasing the rigidity of substantially all of the fluid impermeable barrier 202 may better prevent the fluid collection assembly 200 falling between the legs of the individual and may decrease the likelihood that the fluid impermeable barrier 202 kinks e.g., due to the individual sitting up) compared to the fluid collection assembly 100 shown in FIGS. 1A-1C. However, extending the inflation device 218 from the proximal end region 228 to the distal end region 230 may limit the locations of the vents on the fluid impermeable barrier 202. For example, as shown, the length of the proximal vent 242 may be limited and the lateral vents 244 may need to be shifted inwardly when the inflation device 218 extends along or adjacent to substantially all of the lateral edges 258 of the fluid impermeable barrier 202. Limiting the length of the proximal vent 242 and shifting the lateral vents 244 inwardly may limit air flow through the lateral portions ofthe chamber which may result in pooling of the bodily fluids in such lateral portions of the chamber.

[0075] At least a portion of the inflation devices illustrated in FIGS. 1A-2 extending generally parallel to the longitudinal axis of the fluid impermeable barrier which prevents or at least inhibits bending of the fluid impermeable barrier along the longitudinal axis of the fluid impermeable barrier. Preventing or inhibiting bending of the fluid impermeable barrier along the longitudinal axis may prevent or inhibit pooling or otherwise limiting flow of the bodily fluids at or near the low point of the bend. In other words, preventing or inhibiting bending of the fluid impermeable barrier along the longitudinal axis may facilitate relatively quick flow of the bodily fluids towards the fluid outlet thereby helping maintain the chamber of the fluid collection assemblies dry which, in turn, may make the fluid collection assemblies more comfortable to use and avoid skin degradation caused by constant moisture. However, it is noted that at least a portion of the inflation devices disclosed herein may extend at a non-parallel angle relative to the longitudinal axis of the fluid impermeable barrier. FIG. 3 is a top plan view of a fluid collection assembly 300 including an inflation device 318 extending at a non-parallel angle relative to a longitudinal axis of the fluid impermeable barrier 302, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 300 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein.

[0076] At least a portion of (e.g., all of) the inflation device 318 may extend at any non-parallel angle relative to the longitudinal axis of the fluid impermeable barrier 302. For example, as illustrated, at least a portion of the inflation device 318 may extend at a perpendicular angle relative to the longitudinal axis of the fluid impermeable barrier 302. However, it is noted that the inflation device 318 may extend at any oblique angle such as a smallest angle between the slope of the inflation device 318 and the longitudinal axis of about 10° to about 45°, about 30° to about 60°, or about 45° to about 89°. The inflation device 318 extending at a non-parallel angle relative to the longitudinal axis of the fluid impermeable barrier 302 may prevent or inhibit bending of the fluid impermeable barrier 302 in a direction that is perpendicular to the longitudinal axis. Bending of the fluid impermeable barrier 302 in a direction that is perpendicular to the longitudinal axis may decrease the likelihood that the bodily fluids are received into the porous material which, in turn, may increase the likelihood of the bodily fluids leaking from the chamber or the bodily fluids pooling in the chamber. In other words, the inflation device 318 extending at a non-parallel angle relative to the longitudinal axis may increase the likelihood that thebodily fluids enter the porous material thereby preventing or minimizing leakage and pooling of the bodily fluids.

[0077] The inflation devices disclosed herein may exhibit different positions on and orientations relative to the fluid impermeable barrier than what is illustrated in FIGS. 1A- 3. For example, FIG. 4 is top plan view a fluid collection assembly 400, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 400 is the same as or similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 400 includes an inflation device 418 that extends parallel to the longitudinal axis of the fluid impermeable barrier 402 and is spaced from lateral edges 458 of the fluid impermeable barrier 402. For example, the inflation device 418 may be centrally positioned between the lateral edges 458. The inflation device 418 may extend further from the distal end region 430 than the fluid impermeable barriers of FIGS. 1A-2 without requiring shifting the lateral vents 444 inwardly.

[0078] The inflation devices illustrated in FIGS. 1A-4 are illustrated as being on the outer surface and the top panel of the fluid impermeable barrier. However, the inflation devices disclosed herein may be disposed on the inner surface and / or the bottom panel of the fluid impermeable barrier. For example, FIG. 5 is a cross-sectional view of a fluid collection assembly 500 including at least one inflation device 518 disposed on the inner surface 506 and a bottom panel 526 of a fluid impermeable barrier 502, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 500 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein.

[0079] As previously discussed, the inflation device 518 is disposed on the inner surface 506 of the fluid impermeable barrier 502 (e.g., the inner surface 506 of the top panel 524 or, as shown, the inner surface 506 of the bottom panel 526, as shown) which may provide several benefits. In an example, disposing the inflation device 518 on the inner surface 506 increases the volume of the chamber 508. Increasing the volume of the chamber 508 may allow the chamber 508 to receive large quantities of bodily fluids before overflowing. As such, disposing the inflation device 518 on the inner surface 506 may be beneficial when the fluid collection assembly 500 is configured to be used with individuals with large bladders. In an example, disposing the inflation device 518 on the inner surface 506 decreasing the likelihood that the inflation device 518 is inadvertently popped since the inflation device 518 is covered by at least the fluid impermeable barrier 502. However, it is noted that disposing the inflation device 518 on the inner surface 506may increase the volume of void space in the chamber 508 in which the bodily fluids may pool without being received in the porous material 14.

[0080] As previously discussed, the inflation device 518 is disposed on the bottom panel 526 of the fluid impermeable barrier 502 (e.g. , the outer surface 504 of the bottom panel 526 or, as shown, the inner surface 506 of the bottom panel 526) which may provide several benefits. In an example, disposing the inflation device 518 on the bottom panel 526 decreases the likelihood that the inflation device 518 is inadvertently popped since the inflation device 518 is adjacent to the individual’s legs (which are unlikely to inadvertently pop the inflation device 318) and covered by at least the top panel 524 and the porous material 514. In an example, disposing the inflation device 518 on the inner surface 506 of the bottom panel 526 opens the penis receiving area 532 of the chamber 508 which may minimize contact between the porous material 514 and the penis. Minimizing contact between the porous material 514 and the penis may prevent the porous material 514 from uncomfortably rubbing the penis.

[0081] It is noted that the fluid collection assemblies disclosed herein may include fluid collection assemblies having inflation devices exhibiting any of the orientations and / or positions of the inflation devices of FIGS. 1A-5, including combinations thereof. For example, a fluid collection assembly may include two inflation devices extending along or adjacent to the lateral edges of the fluid impermeable barrier (as shown in one of FIG. 1A or FIG. 2) and a third inflation device extending at a non-parallel angle relative to the longitudinal axis of the fluid impermeable barrier (as shown in FIG. 3).

[0082] FIG. 6A is a top plan view of a fluid collection assembly 600, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 600 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 600 includes a fluid impermeable barrier 602 and at least one inflation device 618.

[0083] The inflation device 618 includes one or more barriers 662. The barriers 662 divide the interior volume defined by the bladder 646 into a plurality of inflation chamber 650. The barriers 662 may include any structure that divide the interior volume of the bladder 646 into the plurality of inflation chambers 650. In an example, the barriers 662 may include a wall that extends into the interior volume of the bladder 646. In an example, the barriers 662 may include thinning of the bladder 646 e.g. , forming a valley between adjacent portions of the bladder 646), such as by crimping portions of the bladder 646 together.

[0084] The barriers 662 may help the inflation device 618 resist or permit bending of the inflation device 618 at certain locations. For example, the barriers 662 may resist bending of the inflation device 618 in any direction that is not parallel to the barriers 662 but may permit (i.e., provide significandy less resistance to) bending of the inflation device 618 in a direction that is parallel to the barriers 662. As such, the direction that the barriers 662 extend may be selected based on the desired bending of the inflation device 618. For example, at least one of the barriers 662 may extend generally perpendicularly to a longitudinal axis of the fluid impermeable barrier 602 when forming a fold in the inflation device 618 that extends generally perpendicular to the longitudinal axis of the inflation device 618 is desirable.

[0085] The barriers 662 may exhibit any suitable structure. FIG. 6B is an example cross-sectional view of a portion of the fluid collection assembly 600 taken along plane 6B-6B, according to an embodiment. As shown in FIG. 6B, the barriers 662 completely isolate the plurality of inflation chambers 650 from each other such that inflation fluids cannot flow between the plurality of inflation chambers 650. In other words, the barriers 662 of the inflation device 618 do not define passageways through which inflation fluids may flow. The barriers 662 prevent all of the inflation device 618 from deflating when the inflation device 618 is inadvertently punctured. Instead, inadvertently puncturing the inflation device 618 merely deflates one of the inflation chambers 650 while the remaining inflation chamber 650 remains inflated. In other words, the barriers 662 allow the remainder of the inflation device 618 to provide rigidity to the fluid impermeable barrier 602 even when one inflation chamber 650 is deflated. The barriers 662 also allow the rigidity of the fluid impermeable barrier 602 to be selectively controlled by intentionally puncturing one or more inflation chamber 650 where rigidity of the fluid impermeable barrier 602 is not desired (e.g., a location where bending of the fluid impermeable barrier 602 is needed) while the remaining inflation chambers 650 remain unpunctured.

[0086] FIG. 6C is an example cross-sectional view of a portion of the fluid collection assembly 600 taken along plane 6C-6C that is different than the example cross-sectional view shown in FIG. 6B, according to an embodiment. As shown in FIG. 6C, the barriers 662' do not completely isolate the plurality of inflation chambers 650’ from each other. In other words, the barriers 662' form passageways between the inflation chambers 650' through which the inflation fluid may flow. The barriers 662' minimize the likelihood that over pressurization of one of the inflation chambers 650' ruptures the inflation device618'. For example, compression of a portion of the inflation device 618' causes inflation fluid to flow from the compressed inflation chamber 650' to other inflation chambers 650' thereby decreasing the likelihood that compressing one inflation chamber 650' ruptures the inflation device 618'.

[0087] The inflation devices illustrated in FIGS. 1A-6C do not include a port. That is, the inflation devices illustrated in FIGS. 1A-6C do not allow inflation fluids to flow into or out of the inflation chambers thereof without puncturing or otherwise rupturing the inflation device. However, any of the inflation devices disclosed herein may include a port that allows inflation fluids to flow into or out of the inflation chambers. Such ports may allow inflation fluids to selectively flow into the inflation chambers, for example, when the inflation devices are provided in a deflated state (e.g., the inflation devices have a negligible effect on the rigidity of the fluid impermeable barrier) and it is desirable to inflate the inflation devices (z.<?., it is desirable to increase the rigidity of the fluid impermeable barrier) or it is desirable to further increase the rigidity of the fluid impermeable barrier. Such ports may also allow inflation fluids to be selectively removed from the inflation chambers, for example, when the inflation devices are overinflated or it is otherwise desirable to decrease the rigidity of the fluid impermeable barrier. FIGS. 7-9 illustrate different ports and components attached to the ports that may allow inflation fluids to be provided or removed from the inflation chambers.

[0088] FIG. 7 is a top plan view of a fluid collection assembly 700, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 700 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 700 includes a fluid impermeable barrier 702 and an inflation device 718. The inflation device 718 includes at least one bladder 746. The bladder 746 includes walls 748 that define an inflation chamber.

[0089] The inflation device 718 also includes a port. The port includes a hole defined by the walls 748 and at least one valve 764 covering the hole. The valve 764 is in fluid communication with the inflation chamber. The valve 764 is configured to selectively permit flow of an inflation fluid into and / or out of the inflation chamber. For example, the valve 764 may allow an inflation fluid to enter the inflation chamber when it is desirable to increase the volume of the bladder 746 which, in turn, increase the rigidity of at least a portion of the fluid impermeable barrier 702. The valve 764 may also enable removing the inflation fluids from the inflation chamber when it is desirable to decreasethe volume of the bladder 746 which, in turn decreases a rigidity of at least a portion of the fluid impermeable barrier 702.

[0090] Adding or removing the inflation fluids into and from the inflation chamber changes the state of the bladder 746. The bladder 746 may exhibit at least a first state and a second state. The amount (volume or weight) of inflation fluids present in the inflation chamber is greater when the bladder 746 is in the second state than when the bladder 746 is in the first state. In an example, the bladder 746 is in the first state when the bladder 746 is in a deflated state (e.g., there are not or substantially no fluids in the inflation chamber). However, it is noted that the bladder 746 may be in the first state when some inflation fluids are present in the inflation chamber. The fluid collection assembly 700 may be provided without any inflation fluids in the inflation chamber (e.g. , the fluid collection assembly 700 is provided with the bladder 746 in the deflated state) thereby preventing the bladder 746 from leaking during shipping and handling and inhibiting contaminant growth (e.g. , bacteria growth) in the inflation chamber before use. In an example, the bladder 746 is in the second state when the bladder 746 is in an at least partially inflated state. The fluid collection assembly 700 may not be provided with the bladder 746 in the second state since the inflation fluids may leak during shipping and handling and the inflation fluids may encourage contaminant (e.g. , bacterial) growth in the inflation chamber more than if the bladder 746 was provided in a deflated state. However, in some examples, the fluid collection assembly 700 is provided in the second state.

[0091] The bladder 746 may exhibit one or more additional states (e.g., a third state, a fourth state, and so forth) besides the first and second states discussed above. In an embodiment, the one or more additional states may include less inflation fluids in the inflation chamber (e.g., is more deflated) than the first state (e.g., the first state is a partially inflated state). In such an embodiment, the one or more additional states may include a deflated or partially deflated state and may be formed by removing inflation fluids from the inflation chamber when the bladder 746 is in the first or second state. In an embodiment, the one or more additional states may include more inflation fluids in the inflation chamber (e.g., is more inflated) than the first state (e.g., the first state is a deflated or partially inflated state) and include less inflation fluids in the inflation chamber than the second state. In such an embodiment, the one or more additional states include a partially inflated state and may be formed by adding or removing inflation fluids to the inflation chamber when the bladder 746 is in the first state or second state,respectively. In an embodiment, the one or more additional states may include more inflation fluids in the inflation chamber than the second state (e.g., the second state is a partially inflated state). In such an embodiment, the one or more additional states may be an at least partially inflated state and may be formed by adding inflation fluids to the inflation chamber when the bladder 746 is in the first state or second state. It is noted that, in some embodiments, the bladder 746 may only include the first and second states. As previously discussed, switching the bladder 746 between the first state and the second state (or any of the other states thereof) changes the rigidity of the fluid impermeable barrier 702.

[0092] In an embodiment, switching the bladder 746 from the first state to the second state has negligible effect on the shape of the fluid impermeable barrier 702 since the bladder 746 is configured to increase the rigidity of the fluid impermeable barrier 702 and, optionally, not change the shape of the fluid impermeable barrier 702. As used herein, negligible effect on the shape of the fluid impermeable barrier 702 refers to not changing the shape of the fluid impermeable barrier 702 to better conform to a shape of anatomy about a urethral opening. Negligible effects on the shape of the fluid impermeable barrier 702 may include forming bulges adjacent to the inflation device 718, allowing portions of the fluid impermeable barrier 702 between or adjacent to the inflation device 718 to droop, increasing the volume of the chamber (not shown), or other similar changes in the shape of the fluid impermeable barrier 702 since such shape changes do not cause the fluid impermeable barrier 702 to conform to the shape of anatomy about a urethral opening. It is noted that shape changes in the fluid impermeable barrier 702 refer to shape changes when the fluid impermeable barrier 702 is resting on a flat surface.

[0093] The bladder 746 may have a negligible effect on the shape of the fluid impermeable barrier 702 because the walls 748 of the bladder 746 may stretch at substantially the same rate as the fluid impermeable barrier 702 as the bladder 746 is inflated. In an example, the walls 748 may stretch at substantially the same rate as the fluid impermeable barrier 702 when the walls 748 and the fluid impermeable barrier 702 exhibit a similar Young’s modulus (e.g., are formed from the same material) and a similar thickness. In an example, the wall 748 may stretch at substantially the same rate as the fluid impermeable barrier 702 when the walls 748 exhibits a Young’s modulus that is greater and a thickness that is less than the fluid impermeable barrier 702 or the walls 748exhibits a Young’s modulus that is less and a thickness that is greater than the fluid impermeable barrier 702.

[0094] In an embodiment, the bladder 746 is configured to change the shape of the fluid impermeable barrier 702 when the bladder 746 switches from the first state to the second state.

[0095] The valve 764 may include any suitable valve configured to allow for the controllable addition and removal of inflation fluids from the inflation chamber. In an embodiment, the valve 764 is a luer valve and includes a male-taper fitting or a femaletaper fitting. In an embodiment, the valve 764 includes a fluid impermeable membrane with a slit or opening formed therein. The slit or opening of the fluid impermeable membrane remains substantially closed when no external load is applied thereto but opens when an external load is applied thereto (e.g., an external load caused by pressing a syringe against the fluid impermeable membrane). In an embodiment, the valve 764 may include a mechanical valve, such as a ball valve, a butterfly valve, or any other suitable mechanical valve. The mechanical valve may be manually operated or controlled using a computer. In an embodiment, the valve 764 may include a one-way valve (e.g., check valve) to limit leaks from the bladder 746 and to make the fluid collection assembly 700 easier to use. In such an embodiment, the valve 764 may only add or remove (but not both) inflation fluid from the inflation chamber and, as such, the fluid collection assembly 700 including the check valve is configured for single use. In an embodiment, the valve 764 may include a two-way valve which allows the inflation fluid to be added and removed from the inflation chamber. In such an embodiment, at least a portion of the fluid collection assembly 700 (e.g., the fluid impermeable barrier 702 and the inflation device 716) may be reusable.

[0096] In an embodiment, as illustrated, the valve 764 may extend outwardly from the bladder 746. For example, the valve 764 may extend from the bladder 746 thereby allowing a user e.g., medical practitioner or patient) of the fluid collection assembly 700 to easily access the valve 764. As shown, the valve 764 may extend a short distance only from the fluid impermeable barrier 702, such as about 2 cm or less, about 1.5 cm or less, about 1 cm or less, about 0.75 cm or less, about 0.5 cm or less, about 0.25 cm or less, or in ranges of about 0.25 cm to about 0.75 cm, about 0.5 cm to about 1 cm, about 0.75 cm to about 1.5 cm, or about 1 cm to about 2 cm. However, the valve 764 may extend a significant distance from the fluid impermeable barrier 702, such as a distance that is about 2 cm or greater, about 5 cm or greater, about 10 cm or greater, about 50 cm orgreater, about 100 cm or greater, about 500 cm or greater, about 1 m or greater, about 2 m or greater, or in ranges of about 2 cm to about 10 cm, about 5 cm to about 1 cm, about 10 cm to about 100 cm, about 50 cm to about 500 cm, about 100 cm to about 1 m, or about 500 cm to about 2 m. When the valve 764 extends a significant distance from the fluid impermeable barrier 702, the valve 764 may include a flexible tube which allows a user of the fluid collection assembly 700 to easily access to the valve 764 while the fluid collection assembly 700 is positioned adjacent to the urethral opening without having the user near the urethral opening (which the patient may find uncomfortable).

[0097] The valve 764 may be positioned on the fluid collection assembly 700 to minimize contact between the valve 764 and the individual since the individual may find the fluid collection assembly 700 uncomfortable when the valve 764 presses into the individual. In an example, the valve 764 is positioned on or adjacent to the distal end region 730 of the fluid impermeable barrier 702 to minimize contact between the valve 764 and the individual. In an example, the valve 764 may be positioned on or adjacent the top panel 728 thereby positioning the top panel 728, the porous material, and the bottom panel between the individual and the valve 764. In an example, the valve 764 may be centrally positioned on the bottom panel since such positioning of the valve 764 may position the valve 764 between the legs of the individual thereby minimizing contact between the valve 764 and the individual.

[0098] FIG. 8A is a top plan view of a fluid collection assembly 800, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 800 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 800 includes a fluid impermeable barrier 802 and an inflation device 818 attached to the fluid impermeable barrier 802.

[0099] The inflation device 818 includes at least one bladder 846 defining an inflation chamber and a port. The inflation device 818 further includes a pump 866 in fluid communication with the port. For example, the inflation device 818 may include an inflation conduit 868 extending from the port (e.g., as shown, the connector 852 defines the port) to the pump 866. The pump 866 is configured to inflate the bladder 846 responsive to an individual actuating the pump 866.

[0100] In an embodiment, the pump 866 is disposed on e.g., attached to) the fluid impermeable barrier 802. For example, the pump 866 may be attached to the top panel 824 and / or the distal end region 830 to minimize direct contact between the pump 866 and the individual since the individual may find such contact uncomfortable. In aparticular embodiment, the pump 866 may be disposed on the rigid structure 835 since it may be difficult for the individual to feel the pump 866 through the rigid structure 835 and the rigid structure 835 provides sufficient support for the pump 866. The pump 866 disposed on the fluid impermeable barrier 802 allows the individual using the fluid collection assembly 800 to easily inflate the inflation device 818 before or after disposing the fluid collection assembly 800 on the individual. Disposing the pump 866 on the fluid impermeable barrier 802 also precludes the individual from having to find a device to inflate the inflation device 818 or, when in a hospital setting, use a wall mounted air outlet that is configured provided air flow since the wall mounted air outlet may be actively used by another process.

[0101] The pump 866 may include any suitable pump 866. In an embodiment, the pump 866 may include a collapsible pump. FIG. 8B is a cross-sectional of a collapsible pump 866a that may be used with the fluid collection assembly 800, according to an embodiment. The collapsible pump 866a includes a base layer 870 and one or more collapsible walls 872 extending from the base layer 870. The base layer 870 and the collapsible walls 872 collectively define an interior chamber 874 In FIG. 8B, the base layer 870 and the collapsible walls 872 are shown as two distinct structures that are attached together though, it is noted, the base layer 870 and the collapsible walls 872 may be integrally formed together. In an example, the base layer 870 is configured to be attached to the fluid impermeable barrier 802. In such an example, the base layer 870 may include an adhesive disposed on the outer surface thereof (not shown) or is otherwise configured to be attached to the fluid impermeable barrier 802. In an example, the base layer 870 is integrally formed with the fluid impermeable barrier 802. That is, the base layer 870 is a portion of the fluid impermeable barrier 802 and the collapsible walls 872 are attached to the portion of the fluid impermeable barrier 802 forming the base layer 870.

[0102] The collapsible pump 866a further includes an inlet 876 and an outlet 878. For example, the collapsible walls 872 or another portion of the collapsible pump 866a may define the inlet 876 and the outlet 878. The inlet 876 is in fluid communication with an exterior i.e., the atmosphere outside of the pump 866a and the inflation device 818) thereby allowing air to flow from the atmosphere into the interior chamber 874 and the outlet 878 may be in fluid communication with the inflation chamber (e.g., is attached to the inflation conduit 868) thereby allowing air in the interior chamber 874 to flow out the outlet 878. The collapsible pump 866a may also include an inlet check valve 880 (e.g., aflap) in fluid communication with the inlet 876. The inlet check valve 880 is configured to allow air to flow from the atmosphere into the interior chamber 874 through the inlet 876 while substantially preventing air from flowing out of the interior chamber 874 through the inlet 876. The collapsible pump 866a may also include an outlet check valve 882 (e.g., flap) in fluid communication with the outlet 878. The outlet check valve 882 is configured to allow air to flow out of the interior chamber 874 through the outlet 878 while substantially preventing air flowing into the interior chamber 874 via the outlet 878.

[0103] During operation, the collapsible walls 872 may be compressed (z.<?., the volume of the interior chamber 874 is decreased). Compressing the collapsible walls 872 may force the air that is present in the interior chamber 874 to flow out of the interior chamber 874 via the outlet 878. The air flowing through the outlet 878 may inflate the bladder 846. After compressing the collapsible walls 872, the collapsible walls 872 may return to their uncollapsed state. In an example, as illustrated, the collapsible pump 866a may include one or more springs 884 that force the collapsible walls 872 to return to their uncollapsed state responsive to the compressive force being removed from the collapsible pump 866a. In an example, the collapsible pump 866a does not include springs 884 and, instead, the inherent resiliency of the collapsible walls 872 is sufficient to return the collapsible walls 872 to their uncollapsed state responsive to the compressive force being removed from the collapsible pump 866a. Returning the collapsible walls 872 to their uncollapsed state (i.e., increasing the volume of the interior chamber 874) may pull air from the exterior into the interior chamber 874 via the inlet 876.

[0104] FIG. 9 is a cross-sectional view of a portion of a fluid collection assembly 900, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 900 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 900 includes a first conduit 986 and a second conduit 988. The first conduit 986 is in fluid communication with a chamber defined by a fluid impermeable barrier e.g., form part of the fluid outlet formed by the fluid impermeable barrier, a rigid structure attached to or forming the fluid outlet, a portion of the chamber adjacent to the fluid outlet, or the conduit attached to the fluid outlet). The second conduit 988 is in fluid communication with an inflation chamber of an inflation device (e.g., form part of an inflation conduit extending from a port of an inflation device, the port, or a portion of an inflation chamber adjacent to the port) such that the second conduit 988 may provide inflation fluids to the inflation chamber. The first and second conduits 986, 988 are illustrated as being adjacent to eachother and sharing a dividing wall therebetween. However, it is noted that the first and second conduits 986, 988 may be spaced from each other and / or do not share a common dividing wall. The first conduit 986 defines a first passageway 990 and the second conduit 988 defines a second passageway 992.

[0105] The fluid collection assembly 900 includes at least one first propeller 994 disposed in the first passageway 990 and at least one second propeller 996 disposed in the second passageway 992. The first and second propellers 994, 996 may be operably coupled together (e.g., using gears 997 and shaft 998) such that rotating the first propeller 994 relative a rotation axis thereof also causes the second propeller 996 to rotate relative a rotation axis thereof.

[0106] During use, a suction is applied to the chamber e.g., chamber 108 of FIGS. IB and 1C) of the fluid collection assembly 900 via the first passageway 990. The suction applied to the chamber pulls bodily fluids towards the fluid outlet and removes the bodily fluids from the chamber via the fluid outlet. The flow of the air and bodily fluids caused by the suction is schematically illustrated using arrow A. The flow of the air and bodily fluids through the first passageway 990 causes the first propeller 994 to rotate about a rotation axis thereof. Such rotation of the first propeller 994 also causes the second propeller 996 to rotate about its axis. The rotation of the second propeller 996 may pull air from an exterior towards the inflation chamber of the inflation device via the second passageway 992. The flow of the air through the second passageway 992 is schematically illustrated with arrow B.

[0107] In an embodiment, the fluid collection assembly 900 includes a check valve 999 (e.g., flap) disposed in or otherwise in fluid communication with the second passageway 992. The check valve 999 may be configured to allow air to flow from an exterior of the fluid collection assembly 900 into the inflation chamber and substantially prevent air flowing from the inflation chamber to the exterior. As such, the check valve 999 may allow the inflation device to remain inflated even after a suction is no longer applied to the chamber of the fluid collection assembly 900. In an embodiment, the fluid collection assembly 900 does not include a check valve 999. In such an embodiment, the inflation of the inflation device depends on the suction provided to the chamber. In other words, the inflation device may be partially deflated by decreasing the suction provided to the chamber, completely deflated by ceasing to provide a suction to the chamber, or inflated by increasing the suction provided to the chamber.

[0108] The inflation devices illustrated in FIGS. 1C, 5, 6B, and 6C are examples of inflation devices that are integrally formed with the fluid impermeable barrier. In other words, the fluid impermeable barrier defines at least a portion of the inflation device. However, it is noted that the inflation devices disclosed herein may be distinct from the fluid impermeable barrier. FIG. 10 is a cross-sectional view of an inflation device 1018, according to an embodiment. The inflation device 1018 may be used in any of the fluid collection assemblies disclosed herein. Except as otherwise disclosed herein, the inflation device 1018 is the same as or substantially similar to any of the inflation devices disclosed herein.

[0109] The inflation device 1018 includes one or more walls 1048. The walls 1048 completely define the inflation chamber 1050. The walls 1048 may include a base surface 1011 that is configured to be attached to the fluid impermeable barrier (not shown). For example, at least a portion of the base surface 1011 may include an adhesive 1013 thereon that allows the inflation base surface 1011 to be attached to the fluid impermeable barrier. The adhesive 1013 also allows the inflation device 1018 to retrofit any fluid collection assembly by disposing the inflation device 1018 on any fluid collection assembly.

[0110] The inflation devices disclosed herein may be used with fluid collection assemblies other than the male fluid collection assemblies illustrated in FIGS. 1A-8, though, it is noted that the inflation devices may be especially beneficial with the male fluid collection assemblies illustrated in FIGS. 1A-8 due to the flimsy structures thereof. FIGS. 11 and 12 are examples of fluid collection assemblies that may include any of the inflation devices disclosed herein.

[0111] FIG. 11 is a cross-sectional view of male fluid collection assembly 1100, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 1100 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 1100 includes a sheath 1120 and a base 1122 (e.g., annular base). The fluid collection assembly 1100 also includes at least one inflation device 1118 attached to at least one of the sheath 1120 or the base 1122 that is configured to increase the rigidity of the sheath 1120 or the base 1122. The inflation device 1118 may include any of the inflation devices disclosed herein.

[0112] The base 1122 is sized, shaped, and made of a material to be coupled to skin that surrounds the male urethral opening (e.g., penis) and have the male urethral opening positioned therethrough. For example, the base 1122 may define an aperture 1160. Thebase 1122 is sized and shaped to be positioned around the male urethral opening (e.g., positioned around and / or over the penis) and the aperture 1160 may be configured to have the male urethral opening positioned therethrough. The base 1122 may also be sized, shaped, made of a material, or otherwise configured to be coupled e.g., adhesively attached, such as with a hydrogel adhesive) to the skin around the male urethral opening (e.g., around the penis). In an example, the base 1122 may exhibit the general shape or contours of the skin surface that the base 1122 is selected to be coupled with. The base 1122 may be flexible thereby allowing the base 1122 to conform to any shape of the skin surface. The base 1122 also defines a hollowed region that is configured to receive (e.g. , seal against) the sheath 1120. The base 1122 is located at a proximal end region 1128 (with respect to a wearer) of the fluid collection assembly 1100.

[0113] The sheath 1120 includes (e.g., may be formed from) a fluid impermeable barrier 1102 that is sized and shaped to fit into the hollowed region of the base 1122. For example, the sheath 1120 may be generally tubular or cup-shaped, as shown. The fluid impermeable barrier 1102 may be similar or identical to and of the fluid impermeable barriers disclosed herein, in one or more aspects. For example, the fluid impermeable barrier 1 102 may be constructed of any of the materials disclosed herein for the fluid impermeable barrier. The fluid impermeable barrier 1102 at least partially defines the chamber 1108. The chamber 1108 may at least temporarily retain bodily fluids therein. As shown, the fluid collection assembly 1100 may include the porous material 1114 therein. The porous material 1114 may be similar or identical any of the porous materials disclosed herein, in one or more aspects. The fluid impermeable barrier 1102 may also define an opening 1110 extending through the fluid impermeable barrier 1102 that is configured to have a male urethral opening positioned therethrough.

[0114] The sheath 1120 also includes at least a portion of the conduit 1134 therein, such as at least partially disposed in the chamber 1108. For example, not shown, the conduit 1134 may extend from the sheath 1120 at the distal end region 1130 to a proximal end region 1128 at least proximate to the opening 1110. The proximal end region 1128 may be disposed near or on the skin around the male urethral opening (e.g., on the penis or pubic area therearound). Accordingly, when an individual lays on their back, bodily fluids (e.g., urine) may aggregate near the opening 1110 against the skin of the subject. The bodily fluids may be removed from the chamber 1108 via the conduit 1134.

[0115] In some examples, the fluid impermeable barrier 1102 may be constructed of a material and / or have a thickness that allows the sheath 1120 to collapse when placedunder vacuum, such as to remove air around a penis in the fluid collection assembly 1100 during use. In such examples, the conduit 1134 may extend only to or into the distal end region 1130 in the chamber 1108 (e.g., not through to the area adjacent the opening 1110). In such examples, urine may be collected and removed from the fluid collection assembly 1100.

[0116] In an example, portions of the chamber 1108 may be substantially empty due to the varying sizes and rigidity of the male penis. However, in some examples, the outermost regions of the chamber 1108 (e.g., periphery of the interior regions of the sheath 1120) may include the porous material 1114. For example, the porous material 1114 may be bonded to the inner surface of the fluid impermeable barrier 1102. The porous material 1114 may be positioned (e.g., at the distal end of the chamber 1108) to blunt a stream of urine from the male urethral opening thereby limiting splashing and / or to direct the bodily fluids to a selected region of the chamber 1108. Since the chamber 1108 is substantially empty (e.g., substantially all of the chamber 1108 forms a reservoir), the bodily fluids are likely to pool at a gravimetrically low point of the chamber 1108. The gravimetrically low point of the chamber 1108 may be at an intersection of the skin of an individual and the fluid collection assembly 1100, a corner formed in the sheath 1120, or another suitable location depending on the orientation of the wearer.

[0117] The fluid collection assembly 1100 includes a cap 1135 at a distal end region 1130. The cap 1135 defines an interior channel through which the bodily fluids may be removed from the fluid collection assembly 1100. The interior channel is in fluid communication with the chamber 1108. The cap 1135 may be disposed over at least a portion of the distal end region 1130 of one or more of the fluid impermeable barrier 1102 or the porous material 1114. The cap 1135 may be made of a polymer, rubber, or any other fluid impermeable material. The cap 1135 may be attached to one or more of the fluid impermeable barrier 1102, the porous material 1114, or the conduit 1134. The cap 1135 may cover at least a portion of the distal end region 1130 of the fluid collection assembly 1100. The cap 1135 may define a fluid outlet 1112 that is sized and configured to receive and fluidly seal against the conduit 1134. The conduit 1134 may extend a distance within or through the cap 1135, such as to the porous material 1114, through the porous material 1114, or to a point set-off from the porous material 1114. In the latter example, as depicted in FIG. 11, the interior channel of the cap 1135 may define a reservoir 1136 therein.

[0118] The reservoir 1136 is an unoccupied portion of the device such as in the cap 1135 and is void of other material. In some examples, the reservoir 1136 is defined at least partially by the porous material 1114 and the cap 1135. During use, the bodily fluids that are in the chamber 1108 may flow through the porous material 1114 to the reservoir 1136. The reservoir 1136 may store at least some of the bodily fluids therein and / or position the bodily fluids for removal by the conduit 1134. In some examples, at least a portion of the porous material 1114 may extend continuously between at least a portion of the opening of the interior channel and chamber 1108 to wick any bodily fluids from the opening directly to the reservoir 1136.

[0119] In some examples (not shown), the fluid impermeable barrier 1102 may be disposed on or over the cap 1135, such as enclosing the cap 1135 within the chamber 1108.

[0120] The proximal end region 1128 may be disposed near or on the skin around the male urethral opening (e.g., around the penis) and the inlet of the conduit 1134 may be positioned in the proximal end region 1128. The outlet of the conduit 1134 may be directly or indirectly coupled to a vacuum source. Accordingly, bodily fluids may be removed from the proximal end region 1 128 of the chamber 1108 via the conduit 1134.

[0121] The base 1122, the sheath 1120, the cap 1135, and the conduit 1134 may be attached together using any suitable method. For example, at least two of the base 1122, the sheath 1120, the cap 1135, or the conduit 1134 may be attached together using at least one of an interference fit, an adhesive, stitching, welding (e.g., ultrasonic welding), tape, any other suitable method, or combinations thereof.

[0122] In some examples (not shown), the fluid collection assembly 1100 may have a one piece design, with one or more of the sheath 1120, the base 1122, and the cap 1135 being a single, integrally formed piece.

[0123] Also as shown, the conduit 1134 may be at least partially disposed with the chamber of a fluid collection assembly. The conduit 1134 may extend from the distal end region 1130 to the proximal end region 1128. For example, the conduit 1134 may extend through the cap 1135 to a point adjacent to the base 1122. The conduit 1134 is sized and positioned to be coupled to a fluid storage container or the vacuum source (e.g., vacuum source 1325 of FIG. 13). An outlet of the conduit 1134 may be operably coupled to the vacuum source, directly or indirectly.

[0124] During operation, a male using the fluid collection assembly 1100 may discharge bodily fluids (e.g. , urine) into the chamber 1108. The bodily fluids may pool orotherwise be collected in the chamber 1108. At least some of the bodily fluids may be pulled through the interior of the conduit 1134 via the inlet. The bodily fluids may be drawn out of the fluid collection assembly 1100 via the vacuum / suction provided by the vacuum source. During operation, the vacuum relief valve may substantially maintain the pressure in the chamber 1108 at atmospheric pressure even though bodily fluids are introduced into and subsequently removed from the chamber 1108.

[0125] Other examples of male fluid collection assemblies that may include any of the inflation devices disclosed herein are disclosed in U.S. Patent Application No. 16 / 433,773 filed on June 6, 2019, the disclose of which is incorporated herein, in its entirety, by this reference.

[0126] FIG. 12 is an isometric view of a female fluid collection assembly 1200, according to an embodiment. The fluid collection assembly 1200 includes a fluid impermeable barrier 1202 defining at least an opening 1208, a chamber (not shown), and a fluid outlet 1212. The fluid collection assembly 1200 also includes at least one porous material PM disposed in a chamber. The fluid collection assembly 1200 may further includes a conduit 1234 is disposed through the fluid outlet 1212 such that an inlet of the conduit 1234 is disposed in the chamber.

[0127] In some examples, the fluid impermeable barrier 1202 may be tubular (ignoring the opening 1208), such as substantially cylindrical (as shown), oblong, prismatic, or flattened tubes. During use, the outer surface of the fluid impermeable barrier 1202 may contact the individual. The fluid impermeable barrier 1202 may be sized and shaped to fit between the labia and / or the gluteal cleft between the legs of a female user. The fluid impermeable barrier 1202 may include at least one inflation device 1218 disposed therein that is the same as or substantially similar to any of the inflation devices disclosed herein.

[0128] The opening 1208 may be an elongated hole in the fluid impermeable barrier 1202. For example, the opening 1208 may be defined as a cut-out in the fluid impermeable barrier 1202. The opening 1208 may be located and shaped to be positioned adjacent to a female urethral opening. The opening 1208 may have an elongated shape because the space between the legs of a female is relatively small when the legs of the female are closed, thereby only permitting the flow of the bodily fluids along a path that corresponds to the elongated shape of the opening 1208 (e.g., longitudinally extending opening 1208).

[0129] The fluid collection assembly 1200 may be positioned proximate to the female urethral opening and the bodily fluids may enter the chamber of the fluid collection assembly 1200 via the opening 1208. The fluid collection assembly 1200 is configured to receive the bodily fluids into the chamber via the opening 1208. When in use, the opening 1208 may have an elongated shape that extends from a first location below the urethral opening (e.g., at or near the anus or the vaginal opening) to a second location above the urethral opening (e.g., at or near the top of the vaginal opening or the pubic hair).

[0130] Other examples of female fluid collection assemblies that may include any of the inflation devices disclosed herein are disclosed in U.S. Patent No. 10,973,678 filed on June 2, 2017, U.S. Patent No. 10,390,989 filed on September 8, 2016, and U.S. Patent No. 10,226,376 filed on June 3, 2017, the disclosure of each of which is incorporated herein, in its entirety, by this reference.

[0131] FIG. 13 is a block diagram of a fluid collection system 1321 for fluid collection, according to an embodiment. The fluid collection system 1321 includes a fluid collection assembly 1300, a fluid storage container 1323, and a vacuum source 1325. The fluid collection assembly 1300 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 1300, the fluid storage container 1323, and the vacuum source 1325 may be fluidly coupled to each other via one or more conduits 1334. For example, fluid collection assembly 1300 may be operably coupled to one or more of the fluid storage container 1323 or the vacuum source 1325 via the conduit 1334. The bodily fluids collected in the fluid collection assembly 1300 may be removed from the fluid collection assembly 1300 via the conduit 1334 which protrudes into the fluid collection assembly 1300. For example, an inlet of the conduit 1334 may extend into the fluid collection assembly 1300, such as to a reservoir therein. The outlet of the conduit 1334 may extend into the fluid collection assembly 1300 or the vacuum source 1325. Suction force may be introduced into the chamber of the fluid collection assembly 1300 via the inlet of the conduit 1334 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 1334.

[0132] The suction force may be applied to the outlet of the conduit 1334 by the vacuum source 1325 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 1323. For example, the outlet of the conduit 1334 may be disposed within the fluid storage container 1323 and an additional conduit 1334 may extend from the fluid storage container 1323 to the vacuum source 1325.Accordingly, the vacuum source 1325 may apply suction to the fluid collection assembly 1300 via the fluid storage container 1323. The suction force may be applied directly via the vacuum source 1325. For example, the outlet of the conduit 1334 may be disposed within the vacuum source 1325. An additional conduit 1334 may extend from the vacuum source 1325 to a point outside of the fluid collection assembly 1300, such as to the fluid storage container 1323. In such examples, the vacuum source 1325 may be disposed between the fluid collection assembly 1300 and the fluid storage container 1323.

[0133] The fluid storage container 1323 is sized and shaped to retain bodily fluids therein. The fluid storage container 1323 may include a bag (e.g., drainage bag), a bottle or cup (e.g., collection jar), or any other enclosed container for storing bodily fluids such as urine. In some examples, the conduit 1334 may extend from the fluid collection assembly 1300 and attach to the fluid storage container 1323 at a first point therein. An additional conduit 1334 may attach to the fluid storage container 1323 at a second point thereon and may extend and attach to the vacuum source 1325. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly 1300 via the fluid storage container 1323. Bodily fluids, such as urine, may be drained from the fluid collection assembly 1300 using the vacuum source 1325.

[0134] The vacuum source 1325 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 vacuum source 1325 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 1300. In some examples, the vacuum source 1325 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 some examples, the vacuum source 1325 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 1300. For example, the vacuum source 1325 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 1325 disclosed herein may include one or more of a switch, a button, a plug, a remote, or any other device suitable to activate the vacuum source 1325.

[0135] While various aspects and embodiments have been disclosed herein, other aspects and embodiments are contemplated. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting.

[0136] Terms of degree (e.g., “about,-’ “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term ofdegree is included with a term indicating quantity, the term of degree is interpreted to mean ± 10%, ±5%, or ±2% of the term indicating quantity. In an example, when the term of degree is used to modify a shape, the term of degree indicates that the shape being modified by the term of degree has the appearance of the disclosed shape. For instance, the term of degree may be used to indicate that the shape may have rounded corners instead of sharp corners, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.

Claims

CLAIMSWhat is claimed is:

1. A fluid collection assembly, comprising: a fluid impermeable barrier including at least one exterior surface and at least one inner surface, the at least one inner surface defining a chamber, the fluid impermeable barrier defining an opening and a fluid outlet; at least one porous material at least partially occupying the chamber; and at least one inflation device attached to or integrally formed with the fluid impermeable barrier, the at least one inflation device defining at least one inflation chamber configured to receive an inflation fluid, the at least one inflation device configured to increase a rigidity of at least a portion of the fluid collection assembly when the at least one inflation chamber is at least partially occupied by the inflation fluid, wherein at least deflating the at least one inflation device causes negligible shape change in the fluid collection assembly when the fluid collection assembly is resting on a surface.

2. The fluid collection assembly of claim 1, wherein the at least one inflation device is attached to or integrally formed with the at least one exterior surface.

3. The fluid collection assembly of any one of claims 1 or 2, wherein the at least one inflation device is attached to or integrally formed with the at least one inner surface.

4. The fluid collection assembly of any one of claims 1-3, wherein the fluid impermeable barrier includes a top panel and a bottom panel opposite the top panel, the bottom panel at least partially defining the opening, the at least one inflation device is attached to or integrally formed with the top panel.

5. The fluid collection assembly of any one of claims 1-4, wherein the fluid impermeable barrier includes a top panel and a bottom panel opposite the top panel, the bottom panel at least partially defining the opening, the at least one inflation device is attached to or integrally formed with the bottom panel.

6. The fluid collection assembly of any one of claim 1-5, wherein at least a portion of the at least one inflation device extends along or adjacent to at least a portion of one or more lateral edges of the fluid impermeable barrier.

7. The fluid collection assembly of any one of claims 1-6, wherein at least a portion of the at least one inflation device is positioned centrally between lateral edges of the fluid impermeable barrier.

8. The fluid collection assembly of any one of claims 1-7, wherein the fluid impermeable barrier includes a proximal end region and a distal end region defining the fluid outlet, the at least one inflation device extends from the distal end region to the proximal end region.

9. The fluid collection assembly of any one of claims 1-8, wherein the fluid impermeable barrier includes a proximal end region and a distal end region defining the fluid outlet, the at least one inflation device extends from the distal end region to an intermediate region between the proximal end region and the distal end region.

10. The fluid collection assembly of any one of claims 1-9, wherein at least a portion of the at least one inflation device extends parallel to a longitudinal axis of the fluid impermeable barrier.

11. The fluid collection assembly of any one of claims 1-10, wherein at least a portion of the at least one inflation devices extends perpendicular to a longitudinal axis of the fluid impermeable barrier.

12. The fluid collection assembly of any one of claims 1-11, wherein the at least one inflation device includes a single inflation chamber.

13. The fluid collection assembly of any one of claims 1-11, wherein the at least one inflation device includes a plurality of inflation chambers.

14. The fluid collection assembly of claim 13, wherein the at least one inflation device includes a barrier between adjacent ones of the plurality of inflation chambers.

15. The fluid collection assembly of any one of claims 1-14, wherein the at least one inflation device includes the port configured to allow the inflation fluid to at least enter the at least one inflation chamber.

16. The fluid collection assembly of claim 15, further comprising a valve in fluid communication with the port, the valve switchable between an open state permitting the inflation fluid to flow therethrough and a closed state restricting flow of the inflation fluid therethrough.

17. The fluid collection assembly of any one of claims 15 or 16, further comprising a pump attached to the port, the pump configured to flow the fluid into the at least one inflation chamber responsive to at least partially compressing the pump.

18. The fluid collection assembly of claim 17, wherein the pump is attached to the fluid impermeable barrier.

19. The fluid collection assembly of any one of claims 17 or 18, wherein thefluid outlet includes a rigid structure and the pump is attached to the rigid structure.

20. The fluid collection assembly of any one of claims 15-19, further comprising: a first propeller disposed in a first passageway that is in fluid communication with the chamber; a second propeller operably coupled to the first propeller such that rotation of the first propeller rotates the second propeller, the second propeller in fluid communication with the at least one inflation chamber.

21. The fluid collection assembly of any one of claims 1-14, wherein the at least one inflation device does not include the port.

22. A fluid collection system, comprising: the fluid collection assembly of any one of claims 1-21; a fluid storage container; and a vacuum source; wherein the chamber of the fluid collection assembly, the fluid storage container, and the vacuum source are in fluid communication with each other so that, when one or more bodily fluids are present in the chamber, a suction provided from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and deposits the bodily fluids in the fluid storage container.

23. A method to use a fluid collection assembly, the method comprising: positioning an opening of the fluid collection assembly adjacent to a urethral opening or positioning a penis through the opening, the fluid impermeable barrier including: a fluid impermeable barrier including at least one exterior surface and at least one inner surface, the at least one inner surface defining a chamber, the fluid impermeable barrier defining the opening and a fluid outlet; and at least one porous material at least partially occupying the chamber; and inflating at least one inflation device attached to or integrally formed with the fluid impermeable barrier with an inflation fluid to increase the rigidity of the fluid collection assembly, the at least one inflation device defining at least one inflation chamber configured to receive an inflation fluid, the at least one inflation device configured to increase a rigidity of at least a portion of the fluid collection assembly when the at least one inflation chamber is at least partially occupied by the inflation fluid, wherein inflating the at least one inflation device causes a negligible shape change in thefluid collection assembly when the fluid collection assembly is resting on a surface.

24. The method of claim 24, further comprising attaching the at least one inflation device to the fluid impermeable barrier.

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