WO2025128394A1

WO2025128394A1 - Fluid collection assemblies inluding at least one pooling inhibiting feature

Info

Publication number: WO2025128394A1
Application number: PCT/US2024/058598
Authority: WO
Inventors: Robert Hine; Taylor Matthew Eley; Kathleen DAVIS; Kathleen GRUPP; Kamil Szymaniak
Original assignee: PureWick Corp
Current assignee: PureWick Corp
Priority date: 2023-12-11
Filing date: 2024-12-05
Publication date: 2025-06-19
Anticipated expiration: 2026-06-11

Abstract

An example fluid collection assembly includes a sheath. The sheath includes at least one fluid impermeable barrier defining at least a chamber, an opening, and at least one fluid outlet. The fluid collection assembly also includes a base attached or attachable to the sheath. The base is configured to be attached to skin at least proximate to a penis. The fluid collection assembly further includes at least one pooling inhibiting feature that is configured to prevent or limit bending or twisting of the sheath.

Description

FLUID COLLECTION ASSEMBLIES INLUDING AT LEAST ONE POOLING INHIBITING FEATURE

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Application No. 63/608,553 filed on December 11, 2023, the disclosure of which is incorporated herein, in its entirety, by this reference.

BACKGROUND

[0002] 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.

[0003] 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

[0004] Embodiments disclosed herein related to fluid collection assemblies including at least one pooling inhibiting feature, fluid collection systems including the same, and methods of using and manufacturing the same. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a sheath including at least one fluid impermeable barrier. The at least one fluid impermeable barrier defines a chamber, an opening, and at least one fluid outlet. The sheath includes a proximal end region defining the opening and a distal end region opposite the proximal end region. The fluid collection assembly also includes a base attached or attachable to the sheath. The base is configured to be attached to skin at least proximate to the penis. The fluid collection assembly further includes at least one pooling inhibiting feature configured to prevent or limit at least one of bending or twisting of the sheath.

[0005] In an embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a sheath including at least one fluid impermeable barrier. The at least one fluid impermeable barrier defines a chamber, an opening, and at least one fluid outlet. The sheath includes a proximal end region defining the opening and a distal end region opposite the proximal end region. The fluid collection assembly also includes a base attached or attachable to the sheath. The base is configured to be attached to skin at least proximate to the penis. The fluid collection assembly further includes at least one pooling inhibiting feature configured to prevent or limit at least one of bending or twisting of the sheath. 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 such 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.

[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 the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[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] FIGS. 1A and IB are a top isometric view and a bottom isometric view, respectively, of a fluid collection assembly in a first state, according to an embodiment.

[0009] FIG. 1C is a cross-sectional view of the fluid collection assembly taken along plane 1C-1C shown in FIG. 1A.

[0010] FIG. ID is a top isometric view of the fluid collection assembly when the sheath exhibits the second state, according to an embodiment.

[0011] FIG. IE is a cross-sectional view of the fluid collection assembly taken along plane IE- IE shown in FIG. ID. [0012] FIGS. 2A and 2B are top isometric views of a fluid collection assembly including an outer shell, according to an embodiment.

[0013] FIG. 3A is an isometric view of a fluid collection assembly including a pooling inhibiting feature disposed in the chamber, according to an embodiment. [0014] FIG. 3B is cross-sectional view of the fluid collection assembly taken along plane 3B-3B shown in FIG. 3A. according to an embodiment.

[0015] FIG. 3C is a cross-sectional view of a fluid collection assembly taken along plane 3B-3B, according to a different embodiment. [0016] FIG. 4 is an isometric view of a fluid collection assembly, according to an embodiment.

[0017] FIG. 5 is an isometric view of a fluid collection assembly, according to an embodiment.

[0018] FIG. 6 is a cross-sectional view of a fluid collection assembly, according to an embodiment.

[0019] FIG. 7 is an isometric view of a fluid collection assembly, according to an embodiment.

[0020] FIG. 8 is a top plan view of a fluid collection assembly, according to an embodiment. [0021] FIG. 9A is a top isometric view of a fluid collection assembly including a conduit that does not extend from the proximal end region of a sheath, according to an embodiment.

[0022] FIG. 9B is a side view of a portion of the fluid collection assembly.

[0023] FIG. 10 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.

DETAILED DESCRIPTION

[0024] Embodiments disclosed herein related to fluid collection assemblies including at least one pooling inhibiting feature, fluid collection systems including the same, and methods of using and manufacturing the same. An example fluid collection assembly includes a sheath. The sheath includes at least one fluid impermeable barrier defining at least a chamber, an opening, and at least one fluid outlet. The fluid collection assembly also includes a base attached or attachable to the sheath. The base is configured to be attached to skin at least proximate to a penis. The fluid collection assembly further includes at least one pooling inhibiting feature that is configured to prevent or limit bending or twisting of the sheath.

[0025] During use, the fluid collection assembly may be positioned such that the opening of the sheath receives a penis (z.e., at least a portion of the penis is positioned in the chamber) or is adjacent to a buried penis. Urine or other bodily fluids may be discharged from the penis or the region about the penis. At least some of the bodily fluids may be received in the chamber and removed from the chamber via the fluid outlet. For example, a conduit may be attached to the fluid outlet or extend through the fluid outlet into the chamber. The conduit may remove at least some of the bodily fluids that are received into the chamber. [0026] At least some conventional fluid collection assemblies that are configured to receive penises include sheaths configured to be flexible (z.e.. the sheaths are unable or substantially unable to maintain its shape when unsupported) to allow the sheaths to conform to the shape of different penises. The flexibility of the sheaths of such conventional fluid collection assemblies can lead to bending or twisting during use. Such bending and twisting of the sheaths of such conventional fluid collection assemblies may form gravimetric low spots that are spaced from the fluid outlet or the inlet of the conduit. Bodily fluids received into the sheaths of such conventional fluid collection assemblies may pool in such gravimetric low spots and be difficult to remove using the fluid outlet and the conduit. The pooling of the bodily fluids in the gravimetric low spots may have a compounding effect since the weight of the pooling bodily fluids may cause additional bending and/or twisting of the sheaths of such conventional fluid collection assemblies thereby allowing additional bodily fluids to pool in the gravimetric low spots. The pooling of the bodily fluids may cause several issues, including leaking of the bodily fluids from the sheaths of such conventional fluid collection assemblies, cause moisture to remain in contact with the penis which may cause discomfort and skin degradation, make using the conventional fluid collection assemblies unsanitary, and cause undesirable odors to originate from the sheaths.

[0027] The fluid collection assemblies disclosed herein prevent or at least inhibit pooling of the bodily fluids in the chamber thereof since the fluid collection assemblies disclosed herein include pooling inhibiting features. The pooling inhibiting features may prevent or inhibit pooling of the bodily fluids by preventing or inhibiting bending and/or twisting of the sheaths compared to substantially similar sheaths that do not include the pooling inhibiting features. The pooling inhibiting features may inhibit or prevent bending or twisting of the sheaths by at least one of effectively increasing a rigidity of at least a portion of the sheath, decreasing the effective size of the sheath, or otherwise inhibiting movement of the sheath that may cause bending or twisting of the sheath compared to a substantially similar sheath that does not include the pooling inhibiting feature. As such, the fluid collection assemblies disclosed herein prevent or at least inhibit pooling of bodily fluids therein which, in turn, prevents or reduces the occurrence of bodily fluid leaks, moisture remaining in contact with the penis, unsanitary conditions, and undesirable odors compared to at least some conventional fluid collection assemblies. Examples of pooling inhibiting features are disclosed below.

[0028] FIGS. 1A and IB are a top isometric view and a bottom isometric view, respectively, of a fluid collection assembly 100 in a first state, according to an embodiment. FIG. 1C is a cross-sectional view of the fluid collection assembly 100 taken along plane 1C-1C shown in FIG. 1A. 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 102 and a base 104. The base 104 is configured to be attached (e.g.. permanently attached to or configured to be permanently attached) to the sheath 102. The base 104 is also configured to be attached to the region about the urethral opening (e.g., penis) of the individual.

[0029] The sheath 102 includes at least one fluid impermeable barrier 106 that is at least partially formed from a first panel 108 (e.g., top panel) and a second panel 110 (e.g, bottom panel). The first panel 108 and the second panel 110 may be attached or integrally formed together (e.g., exhibits single piece construction). In an embodiment, as illustrated, the first panel 108 and the second panel 110 are distinct sheets. The fluid impermeable barrier 106 also defines a chamber 112 between the first panel 108 and the second panel 110, an opening 114 at a proximal end region 118 of the sheath 102, and a fluid outlet 1 16 at a distal end region 120 of the sheath 102. The sheath 102 also includes at least one porous material 124 disposed in the chamber 112.

[0030] The inner surface(s) of the fluid impermeable barrier 106 (e.g.. inner surfaces of the first and second panels 108, 110) at least partially defines the chamber 112 within the fluid collection assembly 100. The fluid impermeable bam er 106 temporarily stores the bodily fluids in the chamber 112. The fluid impermeable barrier 106 may be formed from any of the fluid impermeable materials disclosed herein. As such, the fluid impermeable barrier 106 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 106. [0031] In an embodiment, at least one of the first panel 108 or the second panel 110 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 first panel 108 or the second panel 110 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 first panel 108 and the second panel 110 are formed from at least partially transparent fluid impermeable material. Selecting at least one of the first panel 108 or the second panel 110 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 112 may include a penis receiving area 122 that is configured to receive the penis of the individual when the penis extends into the chamber 112. The penis receiving area 122 may be defined by at least the porous material 124 and at least a portion of the at least partially transparent material of the first panel 108 and/or the second panel 110. In other words, the porous material 124 is positioned in the chamber 112 such that the porous material 124 is not positioned between the penis and at least a portion of the transparent portion of the first panel 108 and/or second panel 110 when the penis is inserted into the chamber 112 through the opening 114. The porous material 124 is generally not transparent and, thus, the portion of the at least partially transparent material of the first panel 108 and/or the second panel 110 that defines the penis receiving area 122 forms a window which allows the person to view into the penis receiving area 122 and examine the penis.

[0032] The opening 114 defined by the fluid impermeable barrier 106 provides an ingress route for bodily fluids to enter the chamber 112 when the penis is a buried penis and allow the penis to enter the chamber 112 (e.g, the penis receiving area 122) when the penis is not buried. The opening 1 14 may be defined by the fluid impermeable barrier 106 (e.g., an inner edge of the fluid impermeable barrier 106). For example, the opening 114 is formed in and extends through the fluid impermeable barrier 106 thereby enabling bodily fluids to enter the chamber 112 from outside of the fluid collection assembly 100. [0033] The fluid impermeable barrier 106 defines the fluid outlet 116 sized to receive the conduit 126. The conduit 126 may be at least partially disposed in the chamber 112 or otherwise in fluid communication with the chamber 112 through the fluid outlet 116. The fluid outlet 116 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 126 thereby substantially preventing the bodily fluids from escaping the chamber 112.

[0034] In an embodiment, the fluid impermeable barrier 106 includes a cap 128 that is distinct from the first and second panels 108, 110. The cap 128 may exhibit a rigidity that is greater than the first and second panels 108, 110. The increased rigidity of the cap 128 may facilitate attachment of the conduit 126 to the fluid impermeable barrier 106 than if the fluid impermeable barrier 106 did not include the cap 128. In an embodiment, the fluid outlet 116 may be formed from a portion of the first panel 108 and the second panel 110 that are not attached or integrally formed together. In such an embodiment, the fluid impermeable barrier 106 may not include the cap 128 which may facilitate manufacturing of the fluid collection assembly 100 may decreasing 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 128 may make securing the conduit 126 to the fluid outlet 116 using interference fit to be difficult though, it is noted, attaching the conduit 126 to the fluid outlet 116 may still be possible. As such, the conduit 126 may be attached to the fluid outlet 116 (e.g., to the first and second panels 108, 110) using an adhesive, a weld, or otherwise bonding the fluid outlet 1 16 to the fluid outlet 116. Attaching the conduit 126 to the fluid outlet 116 may prevent leaks and may prevent the conduit 126 from inadvertently becoming detached from the fluid outlet 116. In an example, the conduit 126 may be attached to the fluid outlet 116 in the same manufacturing step that attaches the first and second panels 108, 110 together.

[0035] The sheath 102 may include at least one porous material 124 disclosed in the chamber 112. The porous material 124 may direct the bodily fluids to one or more selected regions of the chamber 112, such as away from the penis and towards the fluid outlet 116. The porous material 124 may be formed from any of the porous materials disclosed herein. In an example, the porous material 124 may be formed from a single layer, two layers (e.g., a fluid permeable membrane extending across the opening 114 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 124 may be formed from a nonwoven material or a woven material (e.g., spun nylon fibers). In an example, the porous material 124 may include at least one material exhibiting substantially no absorption or at least one absorbent or adsorbent material.

[0036] In an embodiment, the porous material 124 may be a sheet. Forming the porous material 124 as a sheet may facilitate the manufacturing of the fluid collection assembly 100. For example, forming the porous material 124 as a sheet allows the first panel 108, the second panel 110, and the porous material 124 to each be sheets. During the manufacturing of the fluid collection assembly 100, the first panel 108, the second panel 110, and the porous material 124 may be stacked and then attached to each other in the same manufacturing step. For instance, the porous material 124 may exhibit a shape that is the same size or slightly smaller than the size of the first panel 108 and the second panel 110. As such, attaching the first panel 108 and the second panel 110 together along the outer edges thereof may also attach the porous material 124 to the first panel 108 and the second panel 110. The porous material 124 may be slightly smaller than the first panel 108 and the second panel 110 such that the first panel 108 and/or the second panel 110 extend around the porous material 124 such that the porous material 124 does not form a passageway through the fluid impermeable barrier 106 through which the bodily fluids may leak. Also, attaching the porous material 124 to the first panel 108 and/or the second panel 110 may prevent the porous material 124 from significantly moving in the chamber 112, such as preventing the porous material 124 from bunching together near the fluid outlet 116. In an example, the porous material 124 may be attached to the first panel 108 or the second panel 110 (e.g, via an adhesive) before or after attaching the first panel 108 to the second panel 110. In an example, the porous material 124 may merely be disposed in the chamber 112 without attaching the porous material 124 to at least one of the first panel 108 or the second panel 110. In an embodiment, the porous material 124 may exhibit shapes other than a sheet, such as a hollow generally cylindrical shape.

[0037] In an embodiment, the porous material 124 may be configured to wick any bodily fluids away from the opening 114, thereby preventing the bodily fluids from escaping the chamber 112. 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 124, such as not include adsorption of the bodily fluids into the porous material 124. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the porous material 124 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 124 (e.g, absorbency), such as less than about 30 wt% of the dry weight of the porous material 124. 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 124. The porous material 124 may also wick the bodily fluids generally towards an interior of the chamber 112, as discussed in more detail below. In an embodiment, the porous material 124 may include at least one absorbent or adsorbent material.

[0038] In an embodiment, the porous material 124 may include the fluid permeable membrane and a fluid permeable support disposed in the chamber 112. The fluid permeable membrane may cover at least a portion (e.g., all) of the opening 114. The fluid permeable membrane may be composed to wick the bodily fluids away from the opening 114, thereby preventing the bodily fluids from escaping the chamber 112. 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.

[0039] The fluid collection assembly 100 may include the fluid permeable support disposed in the chamber 112. 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 is disposed between the fluid permeable support and the fluid impermeable barrier 106. 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.

[0040] In some examples, the fluid permeable membrane may be omitted. For example, the porous material 124 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 124 may only include the fluid permeable membrane.

[0041] In an embodiment, at least a portion of the porous material 124 (e.g., one or more of the fluid permeable membrane or, more preferably, the fluid permeable support) may be hydrophobic. The porous material 124 may be hydrophobic when the porous material 124 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 124 may limit absorption, adsorption, and solubility of the bodily fluids in the porous material 124 thereby decreasing the volume of bodily fluids held in the porous material 124. In an embodiment, at least a portion of the porous material 124 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 124 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 124.

[0042] In a particular embodiment, the porous material 124 includes a hydrophilic polypropylene or hydrophilic polyethylene outer layer, a bamboo intermediate layer, and a nonwoven polyester (e.g, polyethylene terephthalate) inner layer. The hydrophilic polypropylene or hydrophilic polyethylene outer layer may quickly receive bodily fluids therein due to the hy drophilicity thereof. It is noted that polypropylene and polyethylene are generally not naturally hydrophilic and, as such, may be treated to become hydrophilic. For example, the hydrophilic polypropylene or hydrophilic polyethylene outer layer may include a polyethylene glycol surfactant disposed therein to make the outer layer hydrophilic. The bamboo layer may be more hydrophilic than the hydrophilic polypropylene or hydrophilic polyethylene outer layer. The greater hydrophilicity of the bamboo layer may pull bodily fluids from the hydrophilic polypropylene or hydrophilic polyethylene outer layer, thereby allowing the outer layer to remain dry shortly after receiving the bodily fluids. The polyester layer may be hydrophobic which pushes the bodily fluids towards the fluid outlet 116. It has been surprisingly found that bodily fluids readily flow from the bamboo layer to the polyester layer even though the polyester layer may be hydrophobic or at least less hydrophilic than the bamboo layer. [0043] Further examples of porous materials that may be included in the fluid collection assembly 100 are disclosed in U.S. Patent Application No. 18/003,029 filed on June 30, 2021. 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. U.S. Provisional Patent Application No. 63/241,564 filed on September 8, 2021,

PCT International Application No. PCT/US2022/015418 filed on February 7, 2022, and PCT International Application No. PCT/US2022/015420 filed on February 7, 2022, the disclosure of each of which is incorporated herein, in its entirety, by this reference.

[0044] Generally, the sheath 102 is substantially flat when the penis is not in the penis receiving area 122 and the sheath 102 is resting on a flat surface. The sheath 102 is substantially flat because the fluid impermeable barrier 106 is formed from the first panel 108 and the second panel 110 instead of a generally tubular fluid impermeable barrier. Further, as previously discussed, the porous material 124 may be a sheet, which also causes the sheath 102 to be substantially flat. The sheath 102 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 106 thereabout since such rings and caps may inhibit the sheath 102 being substantially flat. It is noted that the sheath 102 is described as substantially flat because at least one of the porous material 124 may cause a slight bulge to form in the sheath 102 depending on the thickness of the porous material 124, the fluid outlet 116 and/or conduit 126 may cause a bulge thereabout, or the base 104 may pull on portions of the sheath 102 thereabout. It is also noted that the sheath 102 may also be compliant and, as such, the sheath 102 may not be substantially flat during use since, during use, the sheath 102 may rest on a non-flat surface (e.g.. may rest on the testicles, the perineum, and/or between the thighs) and the sheath 102 may conform to the surface of these shapes.

[0045] The ability of the sheath 102 to be substantially flat when the penis is not in the penis receiving area 122 and the sheath 102 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 does not extend into the penis receiving area 122 which causes the sheath 102 to lie relatively flat across the aperture 130 of the base 104. When the sheath 102 lies relatively flat across the aperture 130, the porous material 124 extends across the opening 114 and the aperture 130 and is near the buried penis. As such, the porous material 124 prevents or inhibits pooling of bodily fluids discharged from the buried penis against the skin of the individual since the porous material 124 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 122, even when the penis is fully erect. Additionally, the ability of the sheath 102 to be substantially flat allows the fluid collection assembly 100 to be used more discretely than if the sheath 102 was not substantially flat thereby avoiding possibly embarrassing scenarios.

[0046] When the sheath 102 is substantially flat, the porous material 124 occupies substantially all of the chamber 112 and the penis receiving area 122 is collapsed (shown as being non-collapsed in FIG. 1C for illustrative purposes to show the penis receiving area 122). In other words, the sheath 102 may not define a region that is constantly unoccupied by the porous material 124. When the porous material 124 occupies substantially all of the chamber 1 12, the bodily fluids discharged into the chamber 1 12 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.

[0047] As previously discussed, the first panel 108, the second panel 110, and the porous material 124 may be selected to be relatively flexible. The first panel 108, the second panel 110, and the porous material 124 are relatively flexible when the first panel 108, the second panel HO. and the porous material 124, respectively, are unable to maintain their shape when unsupported. The flexibility of the first panel 108, the second panel 110, and the porous material 124 may allow the sheath 102 to be substantially flat, as discussed above. The flexibility of the first panel 108, the second panel 110, and the porous material 124 may also allow the sheath 102 to conform to the shape of the penis even when the size and shape of the penis changes (e.g., becomes erect) and to minimize any unoccupied spaces in the chamber 112 in which bodily fluids may pool. In an embodiment, at least a portion of the fluid impermeable barrier 106 (e.g, one of the first panel 108 and/or the second panel 110) may be relatively rigid such that the fluid impermeable barrier 106 generally maintains a shape thereof when unsupported, such as a planar or non-planar shape.

[0048] The conduit 126 may be in fluid communication with the chamber 112. The conduit 126 may be used to remove the bodily fluids from the chamber 112. The conduit 126 includes at least one wall defining an inlet, an outlet downstream from the inlet, and a passageway. The outlet of the conduit 126 may be operably coupled to a vacuum source, such as a vacuum pump for withdrawing fluid from the chamber 112 through the conduit 126. The conduit 126 fluidly couples the chamber 112 with the fluid storage container (not shown) or the vacuum source (not show n).

[0049] Locating the inlet of the conduit 126 at or near a location expected to be the gravimetrically low point of the chamber 112 when worn by an individual enables the conduit 126 to receive more of the bodily fluids than if inlet was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors). For instance, the bodily fluids in the porous material 124 may flow in any direction due to capillary' forces. However, the bodily fluids may exhibit a preference to flow in the direction of gravity, especially when at least a portion of the porous material 124 is saturated with the bodily fluids. Accordingly, the inlet of the conduit 126 may be in the fluid collection assembly 100 in a position expected to be at or near the gravimetrically low point when the fluid collection assembly 100 is worn by an individual, such as the distal end region 120.

[0050] As previously discussed, the fluid collection assembly 100 includes a base 104 that is configured to be attached to the sheath 102. For example, the base 104 is configured to be permanently attached to the sheath 102. The base 104 is configured to be permanently attached to the sheath 102 when, for example, when the fluid collection assembly 100 is provided with the base 104 permanently attached to the sheath 102 or the base 104 is provided without being permanently attached to the sheath 102 but is configured to be permanently attached to the sheath 102 at some point in the future.

Permanently attached means that the sheath 102 cannot be detached from the base 104 without damaging at least one of the sheath 102 or the base 104, using a blade to separate the sheath 102 from the base 104, and/or using chemicals to dissolve the adhesive that attaches the sheath 102 from the base 104. The base 104 may be permanently attached to the sheath 102 using an adhesive, sewing, heat sealing, RF welding, or US welding. In an embodiment, the base 104 is configured to be reversibly attached to the sheath 102. In an embodiment, the base 104 is integrally formed with the sheath 102.

[0051] The base 104 includes an aperture 130. The base 104 is permanently attached to the distal end region 120 of the sheath 102 such that the aperture 130 is aligned with the opening 114.

[0052] The base 104 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 104 may define an aperture 130 configured to have the penis positioned therethrough. In an example, the base 104 may exhibit the general shape or contours of the skin surface that the base 104 is configured to be coupled with. The base 104 may be flexible, thereby allowing the base 104 to conform to any shape of the skin surface and mitigate the base 104 pulling on the skin surface. The base 104 may extend laterally past the sheath 102 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.

[0053] The fluid collection assembly 100 includes a pooling inhibiting feature. The pooling inhibiting feature of the fluid collection assembly 100 is that the sheath 102 can change a length thereof. For example, the sheath 102 exhibits a first state when the sheath 102 exhibits a first length and a second state when the sheath 102 exhibits a second state. FIGS. 1A-1C illustrate the sheath 102 when the sheath 102 exhibits the first state. FIG. ID is a top isometric view of the fluid collection assembly 100 when the sheath 102 exhibits the second state, according to an embodiment. FIG. IE is a cross-sectional view of the fluid collection assembly 100 taken along plane 1E-1E shown in FIG. ID. The sheath 102 may be configured to switch from the first state to the second state, from the second state to the first state, or both.

[0054] The ability of the sheath 102 to change a length thereof prevents or inhibits bending and twisting of the sheath 102. For example, it is more difficult to bend the sheath 102 when the sheath 102 is in the second state compared to the first state because the sheath 102 in the second state has less length in which to form a bend. Also, it is more difficult to twist the sheath 102 when the sheath 102 is in the second state compared to the first state because there is less leverage to twist the sheath 102 when the sheath 102 is in the second state. That said, the sheath 102 in the second state may not exhibit a length that is sufficiently large to receive relatively large penises. For example, the sheath 102 in the second state may exhibit a length that is too small to receive at least large, erect penises. However, the sheath 102 may be switched from the second state to the first state when used with penises that are too large for the sheath 102 in the second state.

[0055] The sheath 102 may be provided in the first state or the second state. In an embodiment, the sheath 102 may be provided in the first state. In such an embodiment, the sheath 102 may remain in the first state when the sheath 102 is used with relatively large penises (/.<?., penises that are too large to fit in the sheath 102 when the sheath 102 exhibits the second state). It is noted that the relatively large penis may provide rigidity to the sheath 102 such that bending or twisting of the sheath 102 is limited. However, the sheath 102 may be switched from the first state to the second state when the sheath 102 is used with relatively small penises (z.e., penises that are able to fit into the sheath 102 when the sheath 102 exhibits the second state) thereby reducing bending or twi sting of the sheath 102. In an embodiment, the sheath 102 may be provided in the second state. In such an embodiment, the sheath 102 may remain in the second state when the sheath 102 is used with relatively small penises. However, it is noted that the sheath 102 may be switched from the second state to the first state when the sheath 102 receives relatively large penises. It is noted that the sheath 102 may also be switched between the first and second states during use since the size of the penis may change during use. For example, the sheath 102 may be switched from the second state to the first state when a flaccid penis becomes erect and then the sheath 102 may be switched from the first state to the second state when the erect penis becomes flaccid.

[0056] The sheath 102 may be able to switch from the first state to the second state and vice versa using any suitable technique. In an embodiment, as shown, the sheath 102 may include at least one fold formed therein when the sheath 102 exhibits the second state and the sheath 102 may not include the at least one fold formed therein when the sheath 102 exhibits the first state. Due to the flexibility of the sheath 102 (as previously discussed), folding and unfolding the sheath 102 is an effective technique to switch the sheath 102 between the states thereof. For example, the flexibility of the sheath 102 allows the sheath 102 to switch between the first and seconds states thereof substantially without forming cuts therein. Also, the flexibility of the fluid impermeable barrier 106 allows the sheath 102 to be folded and unfolded as many times as needed without weakening or otherw ise changing the rigidity of the fluid impermeable barrier 106. Other techniques to change the length of the sheath 102 includes forming the sheath 102 from two parts and partially fitting one part inside the other, causing the fluid impermeable barrier to exhibit an accordion structure, or any other suitable technique.

[0057] The sheath 102 may include at least one first fold formed in the first panel 108 and at least one second fold in the second panel 110 when the sheath 102 is in the second state. In an embodiment, the portions of the first and second panels 108. 110 that form the first and second folds may be folded in such a manner that the porous material 124 is not folded when the sheath 102 is resting on a flat surface since folding the porous material 124 may inhibit fluid flow therethrough. In an example, as shown, the portions of the first and second panels 108, 110 that form the first and second folds may both extend away from the chamber 112. In an example, the portions of the first and second panels 108, 110 that are folded may extend into the chamber 112 thought extending the folds into the chamber 112 decrease the volume of the chamber 112 that may hold bodily fluids. [0058] In an embodiment, as previously discussed, the porous material 124 may remain in an unfolded state when the sheath 102 is in the second state and the sheath 102 is resting on a flat surface. To accommodate folding of the fluid impermeable barrier 106 without folding the porous material 124, the porous material 124 may exhibit a length that is less than a length of the chamber 112 measured from opposing portions of the chamber 112 when the sheath 102 is in the first, unfolded stated (z.e., the unfolded state). In other w ords, the porous material 124 may not occupy substantially all of the chamber 112 when the sheath 102 is in the first state and the sheath 102 is disposed on a flat surface. For example, as shown in FIGS. 1A-1C. the porous material 124 may extend from or near the fluid outlet 116 to an intermediate location that is spaced from the proximal end region 118 of the sheath 102. In such an example, the porous material 124 may only cover a portion of the opening 114 (as showTi), all of the opening 114, or none of the opening 114. In a particular embodiment, the porous material 124 may occupy substantially all of the chamber 112 excluding the portions of the chamber 112 defined by the portions of the first and second panels 108. 110 defining the first and second folds when the sheath 102 exhibits the second, folded state.

[0059] In an embodiment, the porous material 124 may occupy all of the chamber 112 when the sheath 102 is in the first, unfolded state and resting on a flat surface. In other words, the porous material 124 may exhibit a length that is substantially equal to the length of the chamber 112. In such an embodiment, the porous material 124 may be folded when the sheath 102 is in the second, folded state.

[0060] In an embodiment, the fluid collection assembly 100 may include at least one fastener 132 that is configured to maintain the sheath 102 in one of the first state or the second state (e.g., maintain the sheath 102 folded). In an example, the fastener 132 includes a plastic fastener having an elongated section 134 and two heads 136 on opposing sides of the elongated section 134. The elongated section 134 may extend through one or more small holes formed in the fluid impermeable barrier 106. The holes are generally kept small enough that, in combination with the contact angle the fluid impermeable barrier 106 forms with the bodily fluids, fluid leaking through the holes is non-existent or negligible. The heads 136 may exhibit a size that is too large to fit through the holes which may allow the plastic fastener to maintain the sheath 102 in the second state. However, elongated section 134 may be easily breakable (e.g., using scissors or pulling the fold apart using a force that is greater than what is typically applied to the sheath 102 during use) and breaking the elongated section 134 may allow the sheath 102 to switch from the second state to the first state. In an example, the fastener 132 may include two magnets or a magnet and a magnetically attractable material that are positioned to maintain the sheath 102 in the second state when brought close together. In an example, the fastener 132 may include a weak adhesive, tape including a weak adhesive, tape that is easily tearable, stitches, or any other suitable fastener.

[0061] In an embodiment, as shown, the fastener 132 may only extend through the fluid impermeable barrier 106. For example, the at least one fastener 132 may include a first fastener extending through the portions of the first panel 108 that form the first fold and a second fastener extending through the portions of the second panel 110 that form the second fold. Only extending the fastener 132 through the fluid impermeable barrier 106 decreases the likelihood that the fastener 132 compresses the porous material 124. In an embodiment, the fastener 132 may extend through the fluid impermeable barrier 106 and the porous material 124. In such an embodiment, a single fastener 132 may maintain the first and second folds thereby facilitate manufacturing and subsequent breaking of the fastener 132.

[0062] The fluid collection assemblies disclosed herein may include one or more pooling inhibiting features instead of or in addition to changing a length of the sheath. For example. FIGS. 2A and 2B are top isometric views of a fluid collection assembly 200 including an outer shell 238, 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 sheath 202.

[0063] The outer shell 238 defines an interior region 240 exhibiting a size and shape that is configured to receive at least a portion of the sheath 202. The interior region 240 of the outer shell 238 may be larger than the sheath 202 such that the interior region 240 may receive the sheath 202 and a penis disposed in the sheath 202.

[0064] The outer shell 238 exhibits a rigidity that is greater than a rigidity of the sheath 202. As such, disposing at least a portion of the sheath 202 in the outer shell 238 effectively increases the rigidity of the portion of the sheath 202 disposed in the outer shell 238 which, in turn, improves the ability of the sheath 202 to resist bending and twisting. The composition and/or structure of the outer shell 238 may cause the outer shell 238 to exhibit a rigidity that is greater than the sheath 202. in an example, the outer shell 238 exhibits a rigidity that is greater than the sheath 202 because the outer shell 238 is formed from a material exhibiting a Young’s modulus that is greater than the material forming the fluid impermeable barrier 206 or because the outer shell 238 exhibits a thickness that is greater than the first and second panels of the fluid impermeable barrier 206. in an example, the outer shell 238 if formed from cardboard, cardstock, rigid plastic, or other rigid material. In an example, the outer shell 238 includes one or more folds 242 formed therein since the folds 242 may increase the bending strength of the outer shell 238.

[0065] In an embodiment, any of the fluid collection assemblies disclosed herein may include a pooling inhibiting feature disposed in the chamber of the sheath. For example, FIG. 3A is an isometric view of a fluid collection assembly 300 including a pooling inhibiting feature disposed in the chamber 312, 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.

[0066] FIG. 3B is cross-sectional view of the fluid collection assembly 300 taken along plane 3B-3B shown in FIG. 3A. according to an embodiment. In FIG. 3B, the fluid collection assembly 300 includes a porous material 324 disposed in the chamber 312 of the sheath 302. At least a portion of the porous material 324 (<?.g., one or more layers or all of the porous material 324) may include one or more fold lines 344 formed therein. For example, at least a portion of the porous material 324 may exhibit a corrugated structure. The fold lines 344 may extend generally parallel to a longitudinal axis of the sheath 302 when the sheath 302 exhibits a maximum length. The fold lines 344 formed in the porous material 324 resist bending and, thus, increase the bending strength of the porous material 324. The porous material 324 supports the rest of the sheath 302 and, thus, the increased bending strength of the porous material 324 prevents or inhibits bending of the sheath 302. It has also been found that the fold lines 344 resist twisting of the porous material 324 which causes the porous material 324 to inhibit twisting of the sheath 302.

[0067] The fold lines 344 may be formed in the porous material 324 using any suitable technique. In an example, the fold lines 344 may be induced by heating the porous material 324. Such heating may melt part of the porous material 324 thereby forming the fold lines 344 or may otherwise cause the formation of the fold lines 344. In an example, the fold lines 344 may be formed by creasing the porous material 324. In an example, the fold lines 344 may be formed by selectively thinning the porous material 324. [0068] As shown in FIG. 3B. the fold lines 344 may form void spaces between the fluid impermeable barrier 306 and the porous material 324. Such void spaces may allow limited pooling of the bodily fluids between the portions of the porous material 324 and fluid impermeable barrier 306 that define the penis receiving area 322. To minimize this pooling, in some embodiments, a folded (e.g, corrugated) structure may be disposed in the chamber that is distinct and separate from the porous material. For example. FIG. 3C is a cross-sectional view of a fluid collection assembly 300 taken along plane 3B-3B, according to a different embodiment. In FIG. 3C, the fluid collection assembly 300 includes a porous material 324' disposed in the chamber 312. The porous material 324' may not include one or more fold lines formed therein. Instead, the fluid collection assembly 300 may include a folded structure 346 (e.g, plastic corrugated structure) disposed in the chamber 312 that is distinct and separate from the porous material 324'. The folded structure 346 may be spaced from the penis receiving area 322 by the porous material 324'. In other words, the folded structure 346 may be positioned between the porous material 324' and the second panel 310. The folded structure 346 may still form void spaces. However, such positioning of the folded structure 346 minimizes pooling of bodily fluids in the void spaces since, generally, the porous material 324' is located below the folded structure 346 such that the porous material 324' may receive any bodily that would otherwise pool in the void spaces. [0069] The folded structure 346 includes one or more fold lines 344. The fold lines 344 may extend generally parallel to a longitudinal axis of the sheath 302 when the sheath 302 exhibits a maximum length. The fold lines 344 formed in the folded structure 346 resist bending and, thus, increase the bending strength of the folded structure 346. The folded structure 346 supports the rest of the sheath 302 and, thus, the increased bending strength of the folded structure 346 prevents or inhibits bending of the sheath 302. It has also been found that the fold lines 344 resist twisting of the folded structure 346 which inhibits twisting of the sheath 302.

[0070] FIG. 4 is an isometric view of a fluid collection assembly 400, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 400 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 400 includes a sheath 402.

[0071] The fluid collection assembly 400 includes at least one strap 448. The strap 448 forms the pooling inhibiting feature of the fluid collection assembly400. The strap 448 is attached to or integrally formed with the fluid impermeable barrier 406. The strap 448 extends from the fluid impermeable barrier 406, such as from the distal end region 420 of the sheath 402. The strap 448 is configured to be attached, either directly or indirectly, to an individual 450. The strap 448 may inhibit or at least prevent bending and/or twisting of the sheath 402. For example, the strap 448 may be pulled such that the sheath 402 is generally taut before attaching the strap 448 to the individual 450. Attaching the strap 448 to the individual 450 may maintain the sheath 402 generally taut, especially if the individual 450 does not move. The strap 448 includes an elongated portion 452 extending between a first end 454 and a second end 456 opposite the first end 454. The strap 448 extends from or near the distal end region 420 of the fluid impermeable barrier 406.

[0072] In an embodiment, the first end 454 may be integrally formed with the fluid impermeable barrier 406. In an embodiment, the first end 454 is distinct from and attached to the fluid impermeable barrier 406. In such an embodiment, the first end 454 may be attached to the fluid impermeable barrier 406 using any suitable technique. Attaching the first end 454 to the fluid impermeable barrier 406 allows the strap 448 to be added to the fluid collection assembly 400 when needed. In an example, as shown, the first end 454 may include a pad having an adhesive on one side and the first end 454 is adhesively attached to the fluid impermeable barrier 406. In an example, the first end 454 may be ultrasonically welded to the fluid impermeable barrier 406. [0073] In an embodiment, the second end 456 is configured to be directly attached to the individual 450 using any suitable technique. For example, the second end 456 may include a pad having an adhesive on one side and the second end 456 is adhesively attached to the individual 450. In an embodiment, the second end 456 is configured indirectly attached to the individual 450. In such an embodiment, the individual 450 may include a wearable item 458. such as long socks. The second end 456 may include one or more features that allows the second end 456 to be attached to the wearable item 458. For example, the second end 456 may include hooks that become entangled with the fibers of the wearable item 458, similar to a hook and loop fastener. Indirectly attaching the second end 456 to the individual 450 avoids any pain associated with detaching a directly attached second end 456 from the individual 450.

[0074] The fluid collection assembly 400 may include any suitable number of straps 448. In an embodiment, the fluid collection assembly 400 may include a single strap 448. It may be easier to handle and attach the single strap 448 to the individual 450 than if the fluid collection assembly 400 included a plurality of straps 448. In an embodiment, the fluid collection assembly 400 may include two straps 448, namely a firs strap and a second strap. In such an embodiment, the first strap may be attached to a first leg of the individual 450 and the second strap may be attached to a second leg of the individual 450 which may allow the straps 448 to prevent or at least inhibit twisting of the sheath 402. In an embodiment, the fluid collection assembly 400 may include three or more straps

448. The three or more straps 448 may allow for two straps 448 to extend from or near the distal end region 420 to prevent or inhibit twisting of the sheath 402 while one or more addition straps 448 extend from a central region of the sheath 402 to prevent or inhibit bending of the sheath 402 when the individual moves. [0075] FIG. 5 is an isometric view of a fluid collection assembly 500, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 500 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 500 includes a sheath 502.

[0076] The fluid impermeable barrier 506 defines two holes at the distal end region 520 thereof. For example, the fluid impermeable barrier 506 may define a first hole on one lateral side of the distal end region 520 and a second hole on the opposing lateral side of the distal end region 520. The first and second holes may form the fluid outlet 516 of the sheath 502. [0077] The fluid collection assembly 500 includes a tube 560. The tube 560 forms the pooling inhibiting feature of the fluid collection assembly 500. The tube 560 may extend between the first and second holes. The tube 560 may exhibit a length that is sufficiently large for the tube 560 to also extend out of the first and second holes. The tube 560 may be fixedly attached to the fluid impermeable barrier 506 such that the tube 560 maintains its position. The tube 560 exhibits a rigidity that is greater than the rigidity of the sheath 502. The increased rigidity of the tube 560 allows the tube 560 to inhibit bending and twisting of the sheath 502 at least at and near the distal end region 520 of the sheath 502. The increased rigidity of the tube 560 also allows the tube 560 to contact and extend between the leg of an individual 550 using the fluid collection assembly 500 thereby preventing or at least inhibiting the sheath 502 from falling between the legs of the individual.

[0078] The tube 560 may include a first open terminal end 562, a second open terminal end (not shown, obscured by cap 568) opposite the first open terminal end 562, and at least one intermediate opening 566. The intermediate opening 566 is in fluid communication with the chamber such that bodily fluids may be removed from the chamber and enter an interior of the tube 560 via the intermediate opening 566. One or both of the first open terminal end 562 or the second open terminal end are configured to be attached to a conduit (not shown) such that the bodily fluids in the tube 560 may be removed therefrom via the conduit. In an embodiment, the conduit is only attached to one of the first open terminal end 562 or the second open terminal end. In such an embodiment, the fluid collection assembly 500 may include a cap 568 to cover one of the first open terminal end 562 or the second open terminal end to prevent bodily fluids leaking from the open terminal end that is not attached to the conduit. [0079] The fluid collection assemblies illustrated in FIGS. 1A-5 illustrate the fluid outlet being located on or near the distal end region of the sheath. The conduit attached to the fluid outlet would likewise extend from the distal end region. The fluid outlet and the conduit extend from the distal end region because, generally, the distal end region is the gravimetrically low point of the sheath during use. As such, the bodily fluids that enter the chamber generally flow towards the distal end region where the bodily fluids may be removed from the chamber via the fluid outlet and the conduit. However, in some settings, the vacuum that is used to remove the bodily fluids from the chamber is located behind the individual or generally towards the head of the individual. For example, wall- mounted vacuum sources in hospitals are generally located behind the bed. When the vacuum is behind the individual, the conduit must be bent to reach the vacuum. Such bending of the conduit may cause the sheath to bend because, for example, the conduit may resist bending. Such bending of the conduit may also cause the sheath to twist. FIGS. 6-9B illustrate fluid collection assemblies including pooling inhibiting features configured to prevent or at least inhibit such bending and twisting of the sheaths.

[0080] FIG. 6 is a cross-sectional view of a fluid collection assembly 600, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 600 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 600 may include a sheath 602 including a fluid impermeable barrier 606 defining a chamber 612.

[0081] The fluid impermeable barrier 606 defines a fluid outlet 616 at or near the proximal end region 618. The fluid collection assembly 600 also includes a conduit 626 positioned in the fluid outlet 616 and extend to or near the portions of the chamber 612 defined by distal end region 620 of the sheath 602. As such, bodily fluids that reach the distal end region 620 may be removed from the chamber 612 using the conduit 626.

Since the fluid outlet 616 is formed in the proximal end region 618 and the conduit 626 extends away from the proximal end region 618, the conduit 626 may be bent less compared to the conduits of other fluid collection assemblies that include the fluid outlet at the distal end region when the vacuum is positioned behind the individual or near the head of the individual which, in turn, may prevent or at least inhibit bending and/or twisting of the sheath 602. Also, positioning the conduit 626 in the chamber 612 causes the conduit 626 to support the sheath 602 thereby preventing or inhibiting bending of the sheath 602.

[0082] In an embodiment, the fluid collection assembly 600 includes a porous material 624 disposed in the chamber 612. The porous material 624 may be positioned between the portions of the conduit 626 extending in the chamber 612 and the penis receiving area 622. For example, the conduit 626 may be positioned between the first panel 608 and at least a portion of the porous material 624. Such positioning of the porous material 624 may prevent the penis from coming in direct contact with the conduit 626 which some individuals may find uncomfortable. Also, spacing the conduit 626 from the penis receiving area 622 may prevent the conduit 626 from forming void spaces in the penis receiving area 622 in which the bodily fluids may pool without being received into the porous material 624. [0083] As previously discussed, the fluid impermeable barrier 606 may be relatively flimsy which may allow the suction provided to the chamber 612 via the conduit 626 to pull the fluid impermeable barrier 606 towards the conduit 626 and block the conduit 626. To prevent the fluid impermeable barrier 606 from blocking the conduit 626, in an embodiment, the porous material 624 may be configured to curve at least partially around the open terminal end 670 of the conduit 626. As such, the porous material 624 may cover (e.g.. extend around) at least a portion of the open terminal end 670 and prevent the fluid impermeable barrier 606 from moving towards the open terminal end 670. The porous material 624 may cover the open terminal end 670 using any suitable technique. In an example, the porous material 624 may exhibit a length that is greater than the length of the chamber 612 thereby causing the porous material 624 to extend around the open terminal end 670 to fit in the chamber 612. In an example, the porous material 624 may be attached to the conduit 626 (e.g., using an adhesive) to keep the porous material 624 extending around the open terminal end 670. [0084] FIG. 7 is an isometric 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 as or substantially similar to the fluid collection assembly 600 of FIG. 6. For example, the fluid collection assembly 700 may include a sheath 702. The sheath 702 may define a fluid outlet 716 at the proximal end region 718 thereof. The fluid collection assembly 700 may also include a conduit 726 positioned in the fluid outlet 716 and extending from the fluid outlet 716 to or near the distal end region 720.

[0085] The fluid collection assembly 700 includes an end piece 771 attached to and extending from a region of the conduit 726 at or near the open terminal end thereof (not shown, obscured). The end piece 771 may include, for example, a semi-truncated conical end piece in fluid communication with the conduit 726 so fluids may enter therethrough.

The end piece 771 exhibits an opening that is larger than the open terminal end of the conduit 726. The larger opening of the end piece 771 distributes the vacuum over a larger area which decreases the likelihood that the vacuum pulls the fluid impermeable barrier 706 towards the opening of the end piece 771. The larger opening of the end piece 771 also makes it difficult for the fluid impermeable barrier 706 to cover and obstruct opening of the end piece 771.

[0086] FIGS. 6 and 7 illustrate the conduit being centrally positioned in the sheath. However, it is noted that the conduits may not be centrally positioned. For example, FIG. 8 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 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 800 may include a sheath 802. The sheath 802 may define a fluid outlet 816 at the proximal end region 818 thereof. The fluid collection assembly 800 may also include a conduit 826 positioned in the fluid outlet 816 and extending from the fluid outlet 816 to or near the distal end region 820.

[0087] The fluid outlet 816 is positioned closer (e.g.. adjacent) to one lateral edge of the sheath 802 than an opposing lateral edge of the sheath 802. Such positioning of the fluid outlet 816 may cause at least a portion of the conduit 826 extending therefrom to be positioned closer (e.g., adjacent) to the one lateral edge of the sheath 802. Positioning the fluid outlet 816 and the conduit 826 towards the lateral edge of the sheath 802 may facilitate operation of the fluid collection assembly 800. For example, during use, the conduit 826 may press against the porous material (not labeled) which may at least partially collapse the pores of the porous material adjacent to the conduit 826. Such collapsed pores may decrease the quantity of bodily fluids that may be received by the porous material and the ability of the porous material to move the bodily fluids received thereby towards the distal end region 820. The central portions of the porous material receive a greater quantity of bodily fluids and move a greater quantity' to bodily fluids towards the distal end region 820 than the lateral portions of the porous material. As such, positioning the conduit 826 towards the lateral edge of the sheath 802 may minimize the negative effect the conduit 826 may have on the ability of the porous material to receive bodily fluids and move the bodily fluids towards the distal end region 820. In an embodiment, as shown, the fluid collection assembly 800 only includes a single conduit 826 disposed in the chamber since two or more conduits in the chamber would compress more of the porous material than the single conduit 826.

[0088] In an embodiment, the conduit 826 may include a first portion 826a that extends generally parallel to a longitudinal axis 874 of the sheath 802 and a second portion 826b that extends perpendicularly or obliquely to the longitudinal axis 874. For example, as shown, the sheath 802 may exhibit a non-rectangular shape. As such, the first portion 826a by itself would be unable to reach the distal end region 820. However, the second portion 826b may allow the conduit 826 to reach the distal end region 820. The second portion 826b may define one or more openings 870 that allow bodily fluids in the distal end region 820 to be received into the conduit 826. The second portion 826b may also prevent or inhibit twisting of the sheath 802. [0089] The conduit may not need to extend from the proximal end region of the sheath to extend from the sheath towards the head of an individual without having a bend formed therein. For example, FIG. 9A is a top isometric view of a fluid collection assembly 900 including a conduit 926 that does not extend from the proximal end region 918 of a sheath 902, according to an embodiment. FIG. 9B is a side view of a portion of the fluid collection assembly 900. Except as otherwise disclosed herein, the fluid collection assembly 900 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein.

[0090] The sheath 902 includes a fluid impermeable barrier 906. The fluid impermeable barrier 906 defines a fluid outlet (not shown, obscured by the connector 976). The fluid outlet may be an opening or hole extending through the fluid impermeable barrier 906. The fluid outlet may be located at or near the distal end region 920 of the sheath 902. For example, the fluid outlet may be formed in the first panel 908 at or near the distal end region 920. The fluid outlet is at or near the distal end region 920 to allow bodily fluids that collect in the distal end region 920 to be removed therefrom.

[0091] The sheath 902 includes a connector 976. The connector 976 is attached to the fluid impermeable barrier 906 such that the connector 976 is in fluid communication with the chamber via the fluid outlet. For example, the connector 976 may include a base portion 978 that is attached to the fluid impermeable barrier 906 and covers the fluid outlet. The connector 976 is also configured to be attached to a conduit 926 and. thus, indirectly connects the chamber and configured to be attached to the conduit 926. For example, the connector 976 may include a conduit attachment portion 980 extending from the base portion 978 that is configured to be attached to the conduit 926. The connector 976 also defines a passageway extending from the base portion 978 to the conduit attachment portion 980 thus allowing the conduit 926 to remove bodily fluids from the chamber. For example, the passageway may extend from a region of the base portion 978 adjacent to the fluid outlet to a terminal end of the conduit attachment portion 980.

[0092] The connector 976 is configured to allow the conduit 926 to extend from the distal end region 920 generally towards the proximal end region 918. In an example, as shown, the conduit attachment portion 980 includes an upwardly extending portion 982 and a laterally extending portion 984 with a bend between the upwardly extending portion 982 and the laterally extending portion 984. The upwardly extending portion 982 is configured to position the laterally extending portion 984 above the base portion 978 such that the base portion 978 does not interfere with attaching the conduit 926 to the lateral extending portion 982. The laterally extending portion 982 is configured to be directly attached to the conduit 926. The laterally extending portion 982 also generally extends in a direction extending from the distal end region 920 to the proximal end region 918 such that attaching the conduit 926 to the laterally extending portion 982 causes the conduit 926 to generally extends in a direction extending from the distal end region 920 to the proximal end region 918. In an example, the conduit attachment portion 980 may extending at an angle relative to the base portion 978.

[0093] The connector 976 may exhibit a rigidity that is greater than the rigidity of the fluid impermeable barrier 906. The increase rigidity⁷ of the connector 976 may facilitate attachment of the conduit 926 to the connector 976 (e.g, via an interference fit) than if the conduit 926 was directly attached to the fluid impermeable barrier 906. The increased rigidity of the connector 976 also allows the conduit attachment portion 980 to generally maintain an orientation thereof.

[0094] In an embodiment, at least a portion of the conduit attachment portion 980 may move relative to the base portion 978. For example, the upwardly extending portion 982 may be configured to rotate (e.g., side to side or tilt) relative to the base portion 978 and/or the laterally extending portion 984 may rotate (e.g., side-to-side or tilt) relative to the upwardly extending portion 982 and the base portion 978. Allowing at least a portion of the conduit attachment portion 980 to move relative to the base portion 978 may allow conduit attachment portion 980 to accommodate movement of the conduit 926 which, in turn, may better inhibit twisting of the sheath 902.

[0095] FIG. 10 is a block diagram of a fluid collection system 1090 for fluid collection, according to an embodiment. The fluid collection system 1090 includes a fluid collection assembly 1000, a fluid storage container 1092, and a vacuum source 1094. The fluid collection assembly 1000 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 1000, the fluid storage container 1092, and the vacuum source 1094 may be fluidly coupled to each other via one or more conduits 1026. For example, fluid collection assembly 1000 may be operably coupled to one or more of the fluid storage container 1092 or the vacuum source 1094 via the conduit 1026. The bodily fluids collected in the fluid collection assembly 1000 may be removed from the fluid collection assembly 1000 via the conduit 1026 which protrudes into the fluid collection assembly 1000. For example, an inlet of the conduit 1026 may extend into the fluid collection assembly 1000, such as to a reservoir therein. The outlet of the conduit 1026 may extend into the fluid collection assembly 1000 or the vacuum source 1094. Suction force may be introduced into the chamber of the fluid collection assembly 1000 via the inlet of the conduit 1026 responsive to suction (e.g, vacuum) force applied at the outlet of the conduit 1026.

[0096] The suction force may be applied to the outlet of the conduit 1026 by the vacuum source 1094 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 1092. For example, the outlet of the conduit 1026 may be disposed within the fluid storage container 1092 and an additional conduit 1026 may extend from the fluid storage container 1092 to the vacuum source 1094. Accordingly, the vacuum source 1094 may apply suction to the fluid collection assembly 1000 via the fluid storage container 1092. The suction force may be applied directly via the vacuum source 1094. For example, the outlet of the conduit 1026 may be disposed within the vacuum source 1094. An additional conduit 1026 may extend from the vacuum source 1094 to a point outside of the fluid collection assembly 1000, such as to the fluid storage container 1092. In such examples, the vacuum source 1094 may be disposed between the fluid collection assembly 1000 and the fluid storage container 1092.

[0097] The fluid storage container 1092 is sized and shaped to retain bodily fluids therein. The fluid storage container 1092 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 1026 may extend from the fluid collection assembly 1000 and attach to the fluid storage container 1092 at a first point therein. An additional conduit 1026 may attach to the fluid storage container 1092 at a second point thereon and may extend and attach to the vacuum source 1094. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly 1000 via the fluid storage container 1092. Bodily fluids, such as urine, may be drained from the fluid collection assembly 1000 using the vacuum source 1094.

[0098] The vacuum source 1094 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 1094 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 1000. In some examples, the vacuum source 1094 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 1094 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 1000. For example, the vacuum source 1094 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 1094 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 1094.

[0099] 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.

[00100] Terms of degree (e.g, "‘about/’ “substantially,” “generally,” etc.) indicate structurally or functionally insignificant variations. In an example, when the term of degree 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 comers instead of sharp comers, curved edges instead of straight edges, one or more protrusions extending therefrom, is oblong, is the same as the disclosed shape, etc.

Claims

CLAIMS What is claimed is:

1. A fluid collection assembly, comprising: a sheath including at least one fluid impermeable barrier, the at least one fluid impermeable barrier defining a chamber, an opening, and at least one fluid outlet, the sheath including a proximal end region defining the opening and a distal end region opposite the proximal end region; a base attached or attachable to the sheath, the base configured to be attached to skin at least proximate to a penis; and at least one pooling inhibiting feature configured to prevent or limit at least one of bending or twisting of the sheath.

2. The fluid collection assembly of claim 1, wherein the at least one pooling inhibiting feature includes at least one fold formed in the fluid impermeable barrier.

3. The fluid collection assembly of claim 2, wherein the sheath includes at least one fastener configured to maintain the at least one fold in the fluid impermeable barrier.

4. The fluid collection assembly of any one of claims 1-3, wherein the at least one pooling inhibiting feature includes an outer shell defining an interior region that is configured to receive at least a portion of the sheath, the outer shell exhibiting a rigidity that is greater than a rigidity of the sheath.

5. The fluid collection assembly of any one of claims 1-4, wherein the at least one pooling inhibiting feature includes at least one sheet having one or more fold lines disposed in the chamber.

6. The fluid collection assembly of claim 5, wherein the one or more fold lines extend generally parallel to a longitudinal axis of the sheath.

7. The fluid collection assembly of any one of claims 5 or 6, wherein the at least one sheet includes at least one porous material .

8. The fluid collection assembly of any one of claims 5-7, further comprising at least one porous material disposed in the chamber, the at least one sheet is separate from and positioned adjacent to the at least one porous material.

9. The fluid collection assembly of any one of claims 1-8, wherein the at least one pooling inhibiting feature includes at least one strap including a first end and a second end, the first end attached or integrally formed with the fluid impermeable barrier, the second end attachable to an individual.

10. The fluid collection assembly of claim 9, wherein the at least one strap includes a first strap configured to be attached to a first leg of the individual and a second strap configured to be attached to a second leg of the individual.

11. The fluid collection assembly of any one of claims 1-10, wherein: the fluid impermeable barrier defines a first hole and a second hole; and the at least one pooling inhibiting feature includes a tube including a first open terminal end. a second open terminal end. and at least one intermediate opening, the tube extending out of the first hole and the second hole, the intermediate opening in fluid communication with the chamber.

12. The fluid collection assembly of claim 11, further comprising a cap, the cap configured to cover one at a time the first open terminal end or the second open terminal end of the tube.

13. The fluid collection assembly of any one of claims 1-12, wherein the proximal end region defines the fluid outlet; and wherein the at least one pooling inhibiting feature includes a conduit positioned in the fluid outlet and extending from the fluid outlet to or near the distal end region.

14. The fluid collection assembly of claim 13, wherein a portion of the conduit extending from the fluid outlet to or near the distal end region extends parallel of a longitudinal axis of the sheath.

15. The fluid collection assembly of claim 14, wherein the portion of the conduit extending generally parallel to a longitudinal axis of the sheath is centrally positioned in the chamber.

16. The fluid collection assembly of claim 14, wherein the portion of the conduit extending generally parallel to a longitudinal axis of the sheath is positioned closer to one lateral side of the chamber.

17. The fluid collection assembly of any one of claims 13-16, wherein the conduit includes an additional portion extending at least one of perpendicularly or obliquely to the longitudinal axis of the sheath.

18. The fluid collection assembly of any one of claims 13-17, wherein a portion of conduit extending from the fluid outlet to or near the distal end region is spaced from the opening by at least one porous material.

19. The fluid collection assembly of any one of claims 13-18, further comprising at least one porous material disposed in the chamber, the at least one porous material extending around at least one inlet of the conduit.

20. The fluid collection assembly of any one of claims 13-19, further comprising an end piece atached to and extending from a region of the conduit at or near an open terminal end of the conduit, the end piece exhibiting an opening that is larger than the inlet.

21. The fluid collection assembly of any one of claims 1-20, further comprising a connector atached to the fluid impermeable barrier and covering the fluid outlet, the connector exhibiting a rigidity that is greater than the rigidity of the at least one fluid impermeable barrier, the connector including a base portion atached to the at least one fluid impermeable barrier and a conduit attachment portion extending generally towards the proximal end region.

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 such 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.