Fluid collection assemblies including a hydrophilic outer layer and a hydrophilic intermediate layer

Abstract

An example fluid collection assembly includes a fluid impermeable barrier. The fluid impermeable barrier defines at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes a porous material at least partially disposed in the chamber. The porous material includes an outer layer, an intermediate layer, at least one inner, support layer, a first bonding layer between the outer layer and the intermediate layer, and a second bonding layer between the intermediate layer and the inner, support layer.

Description

FLUID COLLECTION ASSEMBLIES INCLUDING A HYDROPHILIC OUTER LAYER AND A HYDROPHILIC INTERMEDIATELAYERBACKGROUND

[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 are directed to fluid collection assemblies include a hydrophilic outer layer and hydrophilic intermediate layer, fluid collection systems including the same, and methods of forming and using the same. In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes a porous material disposed in the chamber. The porous material includes an outer layer including at least one outer hydrophilic material. The at least one outer hydrophilic material includes at least one of hydrophilic polypropylene or hydrophilic polyethylene. The porous material also includes an intermediate layer including at least one intermediate hydrophilic material. The porous material further includes an inner, support layer. The porous material additionally includes a first bonding layer between the outer layer and the intermediate layer and a second bonding layer between the intermediate layer and the inner, support layer.

[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 defining at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes a porous material disposed in the chamber. The porous material includes an outer layer including at least one outerhydrophilic material. The at least one outer hydrophilic material includes at least one of hydrophilic polypropylene or hydrophilic polyethylene. The porous material also includes an intermediate layer including at least one intermediate hydrophilic material. The porous material further includes an inner, support layer. The porous material additionally includes a first bonding layer between the outer layer and the intermediate layer and a second bonding layer between the intermediate layer and the inner, support layer. 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.

[0005] In an embodiment, a method to form a fluid collection assembly is disclosed. The method includes forming a porous material attaching an outer layer to an intermediate layer using a first bonding layer and attaching the intermediate layer to an inner, support layer using a second bonding layer. The outer layer includes at least one outer hydrophilic material. The at least one outer hydrophilic material includes at least one of hydrophilic polypropylene or hydrophilic polyethylene. The intermediate layer includes at least one intermediate hydrophilic material. The method also includes disposing the porous material in a chamber defined by a fluid impermeable barrier. The fluid impermeable barrier also defines at least one opening and a fluid outlet.

[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] FIG. 1A is an isometric 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, shown in FIG. 1A.

[0010] FIG. ID is a schematic illustration of a system configured to form the porous material, according to an embodiment.

[0011] FIG. 2A is an isometric view of a fluid collection assembly, according to an embodiment.

[0012] FIG. 2B is a cross-sectional schematic of the fluid collection assembly taken along plane 2B-2B shown in FIG. 2A.

[0013] FIG. 3 is a cross-sectional schematic of male fluid collection assembly, according to an embodiment.

[0014] FIG. 4 is a cross-sectional schematic of a fluid collection assembly, according to an embodiment.

[0015] FIG. 5 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.DETAILED DESCRIPTION

[0016] Embodiments are directed to fluid collection assemblies include a hydrophilic outer layer and hydrophilic intermediate layer, fluid collection systems including the same, and methods of forming and using the same. An example fluid collection assembly includes a fluid impermeable barrier. The fluid impermeable harrier defines at least a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes a porous material at least partially disposed in the chamber. The porous material includes an outer layer, an intermediate layer, at least one inner, support layer, a first bonding layer between the outer layer and the intermediate layer, and a second bonding layer between the intermediate layer and the inner, support layer.

[0017] During use, the fluid collection assembly may be positioned on an individual such that the opening is positioned adjacent to a female urethral opening or receives a male urethral opening (i.e., penis). The individual may discharge one or more bodily fluids, such as urine, blood, or sweat. The bodily fluids may flow through the opening and into the porous material. The bodily fluids may be removed from the chamber via the fluid outlet (e.g., via an inlet of a conduit that is at least partially disposed in the fluid outlet). In an embodiment, a suction may be applied to the chamber from a vacuum source which removes the bodily fluids from the chamber.

[0018] Some conventional fluid collection assemblies include a hydrophobic porous material. Examples of the hydrophobic porous material that may be used in conventional fluid collection assemblies include hydrophobic polyester foam, hydrophobic polyester fabric, hydrophobic polyester compression bandages, spandex compression bandages,polyamide compression bandages, hydrophobic polypropylene foams, hydrophobic polypropylene fabrics, spun nylon fibers, or other synthetic materials. The hydrophobic porous material exhibits a porosity and fluid permeability that allows the hydrophobic porous material to receive bodily fluids from an individual and have the bodily fluids flow therethrough. The hydrophobic porous material is also, inherently, hydrophobic (e.g., exhibits a contact angle with water that is greater than 90°). The hydrophobicity of the hydrophobic porous material pushes the bodily fluids received by the hydrophobic porous material towards an outlet of the conventional fluid collection assemblies and inhibits bodily fluids remaining in the hydrophobic porous material. As such, the hydrophobicity of the hydrophobic porous material allows the conventional fluid collection assembly to be relatively dry a short period of time after receiving one or more bodily fluids from the individual which prevents skin irritation and degradation. However, it has been found that the hydrophobic porous material exhibits relatively poor water absorption and wicking (z.e., spontaneous flow of the bodily fluids received thereby driven by capillary forces and / or capillary pressure). In particular, the hydrophobic porous material exhibits relatively poor water absorption and wicking since, at least initially, the hydrophobicity of the hydrophobic porous material resists receiving the bodily fluids and resists wetting the hydrophobic material. The relatively poor water absorption and wicking ability of the hydrophobic porous material may result in bodily fluids initially being ineffectively received into the hydrophobic porous material which, in turn, causes the bodily fluids to leak from the conventional fluid collection assembly. The relatively poor wicking of the hydrophobic porous material may limit flow of the bodily fluids therethrough until the bodily fluids wet a significant portion of the surfaces of the hydrophobic porous material which may result, at least initially, in limited flow of the bodily fluids through the hydrophobic material and localized saturation of the bodily fluids in the hydrophobic porous material. The limited flow of the bodily fluids through the hydrophobic porous material and / or the localized saturation of the bodily fluids may also result in leakage of the bodily fluids from the hydrophobic porous material.

[0019] Some other conventional fluid collection assemblies attempt to resolve these issues associated with hydrophobic porous material by including a hydrophilic porous material. Example of hydrophilic porous materials that are used in conventional fluid collection assemblies include polyester. The hydrophilic porous material of the conventional fluid collection assemblies exhibit relatively good water absorption and wicking. However, unlike the hydrophobic porous materials discussed above, thehydrophilic porous material retains a significant quantity of bodily fluids received thereby and remains wet for a prolonged period of time. Since the hydrophilic porous material remains wet, the conventional fluid collection assemblies including the hydrophilic porous material may only be used for a short period of time after receiving the bodily fluids to prevent skin irritation and degradation.

[0020] Other conventional fluid collection assemblies attempt to resolve these issues associated with hydrophobic and hydrophilic porous materials by not including any porous materials or by spacing the porous materials from the skin of the individual. However, the conventional fluid collection assemblies that do not include any porous material or include the porous materials spaced from the skin have difficulty receiving bodily fluids and may result in the bodily fluids pooling, both of which may result in leakage of the bodily fluids, skin degradation, and skin irritation.

[0021] The fluid collection assemblies disclosed herein include a porous material. The porous material includes an outer layer, an intermediate layer, and an inner, support layer. The outer layer and the intermediate layer include hydrophilic materials. As will be discussed in more detail below, the outer layer and the intermediate layer include hydrophilic materials. The hydrophilic materials of the outer layer and the intermediate layer allow the porous material to exhibit good water absorption and wicking. In other words, the hydrophilic materials of the outer layer and the intermediate layer allow the porous material to quickly and effectively receive bodily fluids. The outer and intermediate layers also work synergistically together to more quickly and effectively receive the bodily fluids and move the bodily fluids into the porous material than if the porous material only included one of the outer layer or the intermediate layer.

[0022] In an embodiment, the hydrophilicity of the hydrophilic materials of the outer layer and the intermediate layer may be different. In particular, the hydrophilic material of the intermediate layer may exhibit a hydrophilicity that is greater than (e.g., exhibit a contact angle with water that is less than) the hydrophilicity of the hydrophilic material of the outer layer. The lower hydrophilicity of the hydrophilic material of the outer layer causes the outer layer to retain less of the bodily fluids than if the outer layer was formed from the same hydrophilic material as the intermediate layer. In other words, the lower hydrophilicity of the hydrophilic material of the outer layer causes the porous material to feel drier against the skin of the individual than if the outer layer was omitted from the porous material. Further, the greater hydrophilicity of the intermediate layer causes the intermediate layer to pull bodily fluids from the outer layer thereby causing the outerlayer to retain less bodily fluids than if the intermediate layer was omitted from the porous material. As such, the outer and intermediate layers work synergistically to minimize the amount of bodily fluids that contact the patient which, in turn, increases the time period that the fluid collection assembly may be used, minimized patient discomfort, and minimizes skin degradation (e.g., rashes).

[0023] The inner, support layer may facilitate movement of the bodily fluids towards the fluid outlet (e.g., towards an inlet of a conduit disposed through the fluid outlet). For example, the inner, support layer may include at least one hydrophobic material or a material exhibiting a hydrophobicity that is greater than (e.g., contact angle with water that is greater than) either of the outer layer or the intermediate layer. As such, the inner, support layer exhibits a porosity and fluid permeability that allows the bodily fluids to flow therethrough thereby maintaining the inner, support layer dry. Surprisingly, the bodily fluids that are received by the intermediate layer are able to quickly and effectively flow from the intermediate layer to the inner, support layer. The quick and effective removal of bodily fluids from the intermediate layer to the inner, support layer allows the inner, support layer to pull bodily fluids from the intermediate layer into the inner, support layer as the inner, support layer moves the bodily therethrough. For example, the bodily fluids and bonded together via hydrogen bonding. As such, the quick and effective removal of the bodily fluids from the intermediate layer to the inner, support layer and moving said bodily fluids towards the fluid outlet pulls additional bodily fluids from the intermediate layer due to the hydrogen bonding. Pulling the bodily fluids from the intermediate layer into the inner, support layer causes the intermediate layer (and by extension the outer layer since the intermediate layer pulls bodily fluids out of the outer layer) to be substantially dry a short period of time after the individual discharges the bodily fluids into the porous material. In other words, the outer and intermediate layers do not remain wet, thereby allowing the porous material to be used for prolonged periods of time (e.g., greater than 24 hours, greater than 36 hours, or greater than 48 hours). The quick and effective removal of bodily fluids from the intermediate layer to the inner, support layer also allows the inner, support layer to more quickly receive the bodily fluids than if the outer and intermediate layers were omitted. Thus, the porous material of the fluid collection assemblies disclosed herein exhibit the benefits of all of the conventional fluid collection assemblies disclosed herein while preventing or at least minimizing the issues associated with the conventional fluid collection assemblies.

[0024] It has been found that each of the layers of the porous material should directly contact adjacent layers of the porous material for the quick and effective transfer of bodily fluids from the outer layer to the intermediate layer and from the intermediate layer to the inner, support layer to occur. It has been found that it is difficult to maintain direct contact between the adjacent layers of the porous material without using a bonding layer. For example, wrinkles and other air gaps may form between the adjacent layers when the one layer is not tightly wrapped around another layer or the one layer is larger than another layer about which it is wrapped. Wrinkles and other air gaps may also form between the adjacent layers even when the one layer is tightly wrapped around another layer, for instance, due to bending of the porous material during use, stretching of the one layer during use (especially during prolonged use), and / or tearing of one or more of the layers. As such, in an embodiment, the adjacent layers of the porous material may be attached together using a bonding layer to maintain direct contact therebetween.

[0025] Generally, adhesively attaching two different porous layers together has been avoided since the adhesive or other attachment occupies the pores of the porous materials thereby preventing or inhibiting bodily fluids flowing through the porous material. However, the bonding layers disclosed herein are only disposed between a portion of the outer layer and the intermediate layer and between a portion of the intermediate layer and the inner, support layer. For example, the bonding layers may form at least one of distinct patches of the bonding layer that are spaced from other patches of bonding layer or interconnected patches defining holes. In such an example, there are locations between adjacent layers that are not occupied by the bonding layer through which the bodily fluids may flow between adjacent layers without being impeded by the bonding layer. Even though the bonding layer may obstruct flow of the bodily fluids between adjacent layers at certain locations, it has been surprisingly found that the bonding layer has a negligible effect on the quick and effective flow of bodily fluids between the adjacent layers due, in part, to the ability of the layers of the porous material to synergistically receive bodily fluids and move the bodily fluids through the porous material, as previously discussed. This is especially true when the outer layer and the intermediate layer include the particular materials disclosed herein. It has also been found that the locations between the adjacent layers that are not occupied by the bonding layer have minimal effect on the ability of the bonding layer to maintain direct contact between the adjacent layers so long as the minimum dimension of these locations is kept below a threshold value (e.g., lessthan about 5 mm, less than about 4 mm, less than about 3 mm, less than about 2 mm, or less than about 1 mm).

[0026] FIG. 1A is an isometric 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, shown in FIG. 1A. The fluid collection assembly is an example of a fluid collection assembly configured to receive bodily fluids from a female urethral opening. The fluid collection assembly 100 includes a fluid impermeable barrier 102. The fluid impermeable barrier 102 at least defines a chamber 104, at least one opening 106, and a fluid outlet 108. The fluid collection assembly 100 also includes at least one porous material 110 disposed in the chamber 104 that extends across the opening 106. The porous material 110 includes an outer layer 112, an intermediate layer 114, and an inner, support layer 116. The outer layer 112 includes at least one outer hydrophilic material. The intermediate layer 114 includes at least one intermediate hydrophilic material. The porous material 110 also includes a first bonding layer 118 (shown schematically in FIGS. IB and 1C as a bolded line) between the outer layer 112 and the intermediate layer 114 thereby maintaining the outer layer 1 12 and the intermediate layer 1 14 together. Further, the porous material 1 10 includes a second bonding layer 120 (shown schematically in FIGS. IB and 1C as a bolded line) between the intermediate layer 114 and the inner, support layer 116 thereby maintain the intermediate layer 114 and the inner, support layer 116 together.

[0027] The fluid impermeable barrier 102 at least partially defines a chamber 104 (e.g., interior region) and an opening 106. The fluid impermeable barrier 102 temporarily stores the bodily fluids in the chamber 104. 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, a polycarbonate, 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 of the fluid impermeable barrier 102 may be formed from a soft and / or smooth material, thereby reducing chaffing.

[0028] The opening 106 provides an ingress route for bodily fluids to enter the chamber 104. The opening 106 may be defined by the fluid impermeable barrier 102 such as by an inner edge of the fluid impermeable barrier 102. For example, the opening 106 is formed in and extends through the fluid impermeable barrier 102 thereby enabling bodily fluids to enter the chamber 104 from outside of the fluid collection assembly 100.

[0029] In some examples, the fluid impermeable barrier 102 may define a fluid outlet 108 sized to receive the conduit 126. The at least one conduit 126 may be disposed in the chamber 104 via the fluid outlet 108. The fluid outlet 108 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 126 or the at least one tube thereby substantially preventing the bodily fluids from escaping the chamber 104.

[0030] As previously discussed, the fluid collection assembly 100 includes porous material 110 disposed in the chamber 104. The porous material 110 may cover at least a portion (e.g., all) of the opening 106. The porous material 110 is exposed to the environment outside of the chamber 104 through the opening 106. The porous material 110 may include an outer layer 112, an intermediate layer 114, and at least one inner, support layer 116 that are each distinct from each other (e.g., formed from different materials, exhibit different contact angles with water, etc.).

[0031] The outer layer 112 of the porous material 110 is positioned within the chamber 104 to extend across the opening 106. The outer layer 112 is positioned in the porous material 110 to be closer to the urethral opening of the individual than the intermediate layer 114. In other words, the outer layer 112 may include the portions of the porous material 110 that initially receive the bodily fluids from the individual. As such, in an embodiment, the outer layer 112 may include at least one hydrophilic material. For example, the outer layer 112 is configured to quickly receive the bodily fluids discharged from the individual since the outer layer 112 may initially receive (or at least receive before the intermediate layer 114) the bodily fluids to prevent the bodily fluids leaking from the porous material 110. As previously discussed, the outer layer 112 is able to quickly receive the bodily fluids and, thus, forming the outer layer 112 from at least one hydrophilic material allows the outer layer 112 to quickly receive the bodily fluids.

[0032] As previously discussed, the outer layer 112 includes an outer hydrophilic material. The outer hydrophilic material is hydrophilic. The hydrophilicity of the outer hydrophilic material and the outer layer 112 may cause the outer layer 112 to quickly receive bodily fluids therein, thereby preventing or at least inhibiting leakage of bodilyfluids caused by a large discharge of bodily fluids over a short period of time. The outer hydrophilic material may be hydrophilic when the outer hydrophilic material exhibits a contact angle with water (a major constituent of bodily fluids) that is about 20° to about 30°, about 25° to about 35°, about 30° to about 40°, about 35° to about 45°, about 40° to about 50°, about 45° to about 55°, about 50° to about 60°, about 55° to about 65°, about 60° to about 70°, about 65° to about 75°, about 70° to about 80°, about 75° to about 85°, or about 80° to 90°. Generally, increasing the hydrophilicity of the outer layer 112 (i.e., decreasing the contact angle between the outer layer 112 and water) increases the quantity of bodily fluids that the outer layer 112 may receive over a certain period of time. However, increasing the hydrophilicity of the outer layer 112 may increase the quantity of bodily fluids that are retained in the outer layer 112 after the outer layer 112 receives the bodily fluids. As such, the hydrophilicity of the outer layer 112 may be selected based on balancing the need to receive bodily fluids quickly while also keeping the porous material 110 dry.

[0033] As will be discussed in more detail below, the outer hydrophilic material is selected to exhibit a hydrophilicity that is less than (e.g., exhibit a contact angle that is greater than) the intermediate hydrophilic material of the intermediate layer 1 14. Since the outer hydrophilic material is hydrophilic, the outer hydrophilic material is able to quickly receive bodily fluids. However, the decreased hydrophilicity of the outer hydrophilic material relative to the inner hydrophilic material allows the portions of the porous material 110 that contact the patient to be drier than if the outer layer 112 or the intermediate layer 114 was omitted from the porous material 110.

[0034] In an embodiment, the outer hydrophilic material may include at least one of hydrophilic polypropylene or hydrophilic polyethylene, such as a blend of hydrophilic polypropylene and hydrophilic polyethylene. It is noted that, generally, polypropylene and polyethylene are hydrophobic. As such, as used herein, hydrophilic polypropylene and hydrophilic polyethylene may refer to polypropylene and polyethylene, respectively, that are treated to increase the hydrophilicity (e.g., decrease the contact angle with water) thereof using any suitable technique, such as by at least one of thin layer deposition, surfactant coating, plasma treatment, graft polymerization, or physical modification. It has been found that hydrophilic polypropylene and hydrophilic polyethylene operate more synergistically with the other layers of the porous material 110 compared to other hydrophilic materials that may form the outer layer 112. For example, it has been found that hydrophilic polypropylene and hydrophilic polyethylene are better able to quicklyand effectively receive bodily fluids therein, transfer the bodily fluids to the intermediate layer 114, and have the intermediate layer 114 pull additional quantities of the bodily fluids from the outer layer 112 compared to at least some other hydrophilic materials.

[0035] That said, the outer hydrophilic material may include one or more additional hydrophilic materials other than or in addition to hydrophilic polypropylene and hydrophilic polyethylene. For example, the hydrophilic material may include at least one of natural or treated acrylics, polyvinylchloride, polyester, polyurethane, cellulose-based fibers, or any other suitable hydrophilic material.

[0036] The outer layer 112 of the porous material 110 may be selected to exhibit a density of about 50 kg / m3to about 100 kg / m3, about 75 kg / m3to about 125 kg / m3, about 100 kg / m3to about 150 kg / m3, about 125 kg / m3to about 175 kg / m3, about 150 kg / m3to about 200 kg / m3, about 175 kg / m3to about 225 kg / m3, about 200 kg / m3to about 250 kg / m3, about 225 kg / m3to about 275 kg / m3, about 250 kg / m3to about 300 kg / m3, about 275 kg / m3to about 325 kg / m3, about 300 kg / m3to about 350 kg / m3, about 325 kg / m3to about 375 kg / m3, or about 350 kg / m3to about 400 kg / m3.

[0037] As previously discussed, the outer layer 112 may be formed from a hydrophilic material which may cause the outer layer 1 12 to retain the bodily fluids therein. To decrease the quantity of bodily fluids retained by the outer layer 112, the outer layer 112 may be configured to be relatively thin. For example, the outer layer 112 may be configured to exhibit a thickness measured perpendicularly to the longitudinal axis 130 (<?.g., measured radially) that is about 2 mm or less, about 1.5 mm or less, about 1.25 mm or less, about 1 mm or less, about 800 pm or less, about 700 pm or less, about 600 pm or less, about 500 pm or less, about 400 pm or less, about 300 pm or less, about 250 pm or less, about 200 pm or less, about 150 pm or less, about 130 pm or less, about 100 pm or less, about 75 pm or less, about 60 pm or less, about 50 pm or less, about 40 pm or less, about 30 pm or less, about 25 pm or less, about 20 pm or less, or in ranges of about 20 pm to about 30 pm, about 25 pm to about 40 pm, about 30 pm to about 50 pm, about 40 pm to about 60 pm, about 50 pm to about 75 pm, about 60 pm to about 100 pm, about 75 pm to about 130 pm, about 100 pm to about 150 pm, about 130 pm to about 200 pm, about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to about 600 pm, about 500 pm to about 700 pm, about 600 pm to about 800 pm, about 700 pm to about 1 mm, about 800 pm to about 1.25 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm. The relatively small thickness of the outer layer 112 decreases the overall volume of the outer layer 112thereby decreasing the volume of bodily fluids that may be retained in the outer layer 112. The decreasing volume of bodily fluids held within the outer layer 112 allows the air flow through the chamber 104 to quickly evaporate the bodily fluids that are retained in the outer layer 112 (i.e., the bodily fluids that failed to transfer from the outer layer 112 to the intermediate layer 114) thereby maintaining the porous material 110 dry. Further, decreasing the thickness of the outer layer 112 may allow the intermediate layer 114 to pull more bodily fluids from the outer layer 112.

[0038] The outer layer 112 of the porous material 110 may be selected to exhibit a basis weight of about 5 grams per square meter (“gsm”) to about 10 gsm, about 7.5 gsm to about 15 gsm, about 10 gsm to about 20 gsm, about 15 gm / m2to about 25 gsm, about 20 gsm to about 30 gsm, about 25 gsm to about 35 gsm, about 30 gsm to about 40 gsm, about 35 gsm to about 45 gsm, about 40 gsm to about 50 gsm, about 45 gsm to about 55 gsm, about 50 gsm to about 60 gsm, or about 55 gsm to about 70 gsm. In a particular embodiment, the outer layer 112 exhibits a basis weight of about 10 gsm to about 35 gsm. The basis weight of the outer layer 112 is a function of the density and thickness of the outer layer 112. As such, the basis weight of the outer layer 112 may be selected for any of the same reasons as the density and thickness of the outer layer 112. It is noted that the surface area of the outer layer 112 depends, in part, on the basis weight thereof. As such, increasing the basis weight of the outer layer 112 (to an extent) may increase the surface area of the outer layer 112. How quickly the outer layer 112 is able to pull bodily fluids into itself depends, in part, on the surface area thereof. In other words, increasing the basis weight of the outer layer 112 may improve the rate at which the outer layer 112 may receive the bodily fluids. However, increasing the basis weight of the outer layer 112 may decrease the volume of the void space of the outer layer 112 that may temporarily hold the bodily fluids therein. As such, the basis weight of the outer layer 112 may be selected by balancing these factors.

[0039] As previously discussed, the outer layer 112 is formed from a plurality of fibers. The plurality of fibers may exhibit an average length and an average lateral dimension (e.g. , diameter). In an example, the plurality of fibers may be selected to exhibit an average length that is about 500 pm to about 2 mm, about 1 mm to about 3 mm, about 2 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7 mm, about 6 mm to about 8 mm, about 7 mm to about 9 mm, about 8 mm to about 1 cm, about 9 mm to about 1.2 cm, about 1 cm to about 1.4 cm, about 1.2 cm to about 1.6 cm, about 1.4 cm to about 1.8 cm, about 1.6 cm to about 2 cm,about 1.8 cm to about 2.25 cm, about 2 cm to about 2.5 cm, about 2.25 cm to about 2.75 cm, about 2.5 cm to about 3 cm, about 2.75 cm to about 3.25 cm, about 3 cm to about 3.5 cm, about 3.25 cm to about 3.75 cm, about 3.5 cm to about 4 cm, about 3.75 cm to about4.25 cm, about 4 cm to about 4.5 cm, about 4.25 cm to about 4.75 cm, about 4.5 cm to about 5 cm, about 4.75 cm to about 5.5 cm, about 5 cm to about 6 cm, about 5.5 cm to about 6.5 cm, about 6 cm to about 7 cm, about 6.5 cm to about 7.5 cm, about 7 cm to about 8 cm, about 7.5 cm to about 8.5 cm, about 8 cm to about 9 cm, about 8.5 cm to about 9.5 cm, or about 9 cm to about 10 cm. In an example, the fibers may exhibit an average lateral dimension (e.g., diameter) that is about 1 pm to about 2 pm, about 1.5 pm to about 3 pm, about 2 pm to about 4 pm, about 3 pm to about 5 pm, about 4 pm to about 7 pm, about 6 pm to about 10 pm, about 8 pm to about 12.5 pm, about 10 pm to about 15 pm, about 12.5 pm to about 17.5 pm, about 15 pm to about 20 pm, about 17.5 pm to about 25 pm, about 20 pm to about 30 pm, about 25 pm to about 35 pm, about 30 pm to about 40 pm, about 35 pm to about 45 pm, about 40 pm to about 50 pm, about 45 pm to about 55 pm, about 50 pm to about 60 pm, about 55 pm to about 65 pm, about 60 pm to about 70 pm, about 65 pm to about 75 pm, about 70 pm to about 80 pm, about 75 pm to about 85 pm, about 80 pm to about 90 pm, about 85 pm to about 95 pm, or about 90 pm to about 100 pm. The average length and average lateral dimension of the fibers may be selected such that the fibers exhibits an average aspect ratio. For example, the average length and average lateral dimension of the fibers may be selected such that the fibers exhibit an average aspect ratio (average length: average lateral dimension) of about 100: 1 to about 200:1, about 150:1 to about 250:1, about 200:1 to about 300:1, about 250:1 to about 350:1, about 300:1 to about 400: 1, about 350:1 to about 450: 1, about 400:1 to about500:1, about 450: 1 to about 550:1, about 500: 1 to about 600:1, about 550: 1 to about650:1, about 600:1 to about 700: 1, about 650: 1 to about 750: 1, about 700: 1 to about800:1, about 750:1 to about 850:1, about 800: 1 to about 900: 1, about 850:1 to about950:1, or about 900:1 to about 1,000: 1.

[0040] The average length, average lateral dimension, and the average aspect ratio of the fibers may be selected based on a number of factors. In an example, increasing the aspect ratio (e.g., decreasing the average length and / or increasing the average lateral dimension) increases the durability of the outer layer 112 but may decrease the strength of the outer layer 112. In an example, increasing the aspect ratio e.g., increasing average length) of the fibers may increase the mechanical binding of the fibers. For instance, increasing the aspect ratio of the fibers facilitates entanglement of the fibers whichincreases the strength and durability of the outer layer 112. The entanglement of the fibers may also preclude or minimize the amount of other binding techniques that are applied to the outer layer 112, such as heat, chemical binding, or other mechanical binding (e.g., further entanglement caused by needle punching or high pressure water jets). However, increasing the aspect ratio of the fibers may make dispersion of the fibers more difficult (e.g., uniformity of the outer layer 112 difficult). Further, increasing the aspect ratio may limit the type of non woven webs that may form the outer layer 112. For instance, fibers with large average lengths e.g., large aspect ratios) may not be used in carded webs and may have to be used in air laid webs. In an example, decreasing the aspect ratio may decrease the entanglement of the fibers thereby necessitating further binding of the fibers. As such, the average length, average lateral dimension, and average aspect ratio of the fibers may be selected based on the desired strength, mechanical binding between the fibers, the amount of processing of the outer layer 112 (e.g., is further processing to increasing the binding via heat, etc. desired), the type of nonwoven web that includes the fibers, the uniformity of the fibers, etc.

[0041] Generally, the average person discharges urine at a rate of about 6 ml / s to about 50 ml / s, such as at a rate of about 10 ml / s to about 25 ml / s. The rate at which the person urinates may vary, such as based on the size of the person and the age of the person. The outer layer 112 may be selected to receive bodily fluids and have the bodily fluids flow through a portion thereof at a rate that is comparable to the rate at which the individual discharges bodily fluids to prevent leaks. For example, the outer layer 112 may be selected to receive bodily fluids and have the bodily fluids flow through a portion thereof at a rate that is greater than about 6 ml / s, greater than about 10 ml / s, greater than about 20 ml / s, greater than about 30 ml / s, greater than about 40 ml / s, greater than about 50 ml / s, or in ranges of about 6 ml / s to about 10 ml / s, about 8 ml / s to about 12 ml / s, about 10 ml / s to about 15 ml / s, about 12.5 ml / s to about 17.5 ml / s, about 15 ml / s to about 20 ml / s, about 17.5 ml / s to about 22.5 ml / s, about 20 ml / s to about 25 ml / s, about 22.5 ml / s to about 27.5 ml / s, about 25 ml / s to about 30 ml / s, about 27.5 ml / s to about 35 ml / s, about 30 ml / s to about 40 ml / s, about 35 ml / s to about 45 ml / s, or about 40 ml / s to about 50 ml / s.

[0042] The rate at which the outer layer 112 receives bodily fluids and has the bodily fluids flow through a portion thereof may depend on a number of factors. In an example, the rate at which the outer layer 112 receives bodily fluids and has the bodily fluids flow through a portion thereof may depend inversely on the density and weight basis of theouter layer 112, wherein increasing the density and / or weight basis of the outer layer 112 may decrease the rate at which the outer layer 112 receives bodily fluids and has the bodily fluids flow through a portion thereof and vice versa. In an example, the rate at which the outer layer 112 receives bodily fluids and has the bodily fluids flow through a portion thereof may depend on the hydrophilicity of the outer layer 112. In an example, the rate at which the outer layer 112 receives bodily fluids and has the bodily fluids flow through a portion thereof may depend on the type of nonwoven web (e.g. , carded web, needle punched web, etc.) since each type of nonwoven web may exhibit a different rate at which the outer layer 112 captures and transports the bodily fluids.

[0043] As previously discussed, the outer layer 112 may be formed from at least one non wo ven web. The outer layer 112 may be formed from any suitable non woven web. In an embodiment, the nonwoven web of the outer layer 112 includes at least one carded web. The carded web includes a plurality of fibers that may be generally oriented in the same direction. The generally same orientation of the fibers of the carded web cause the carded web to be anisotropic. For example, the strength of the carded web is greatest when a force applied thereto is generally parallel to the fibers, but the strength of the carded web decreases as the force applied thereto becomes more oblique or perpendicular to the orientation of the fibers. As such, the carded web may need to be positioned in the chamber 104 to mitigate forces being applied to the carded web that are not generally parallel to the orientation of the fibers or requires addition binding between the fibers (e.g., heat or chemical) to prevent unsatisfactory wear of the carded web. The initial flow the bodily fluids through the carded web may vary depending on whether the bodily fluids are flowing parallel, obliquely, or perpendicular to the orientation of the fibers. As such, selecting the nonwoven web to include the carded web allows for selecting the strength and flow characteristics of the porous material 110 based on the orientation of the fibers. Even though the fibers are generally oriented, the orientation of each of the fibers may slightly vary which causes the porosity of the carded web to be sufficiently high that the carded web exhibits any of the density, thickness, basis weight, and flow rates disclosed herein.

[0044] In an embodiment, the nonwoven web of the outer layer 112 may include at least one needle punched web. The needle punched web may be formed from a sheet including a plurality of fibers. The sheet may include a plurality of randomly oriented fibers (e.g., the fibers are generally parallel to and randomly oriented in the plane), or generally oriented fibers e.g., a carded web) since the orientation of the fibers may betterfacilitate flow of the bodily fluids therethrough. A plurality of needles (e.g. , a plurality of barbed needles) are inserted into the sheet in a direction that is generally parallel to a thickness of the sheet which causes some of the fibers to become entangled and interlocked. For example, insertion of the needles into the sheet cause some of the fibers to reorient and migrate from the surface of the sheet to an interior thereof to form columns. The entanglement of the fibers caused by the insertion of the needles may sufficiently entangle the fibers such that no additional binding is necessary to bond the fibers together. The entanglement of the fibers may cause the needle punched web to exhibit more isotropic properties compared to the carded web and, thus, may not require specific orientation in the chamber 104 or additional binding of the fibers. The needle punched web may exhibit good flow features. For example, the needles extending into the sheet may form divots which facilitate flow of the bodily fluids vertically through the needle punched web.

[0045] In an embodiment, the nonwoven web of the outer layer 112 may include at least one air laid web. The air laid web may exhibit a plurality of randomly oriented fibers. The plurality of random fibers may exhibit a length that is sufficiently large that the fibers become entangled and do not need to be bounded together or the fibers may be bonded. Due to the random orientation of the fibers, the air laid web tends to be isotropic and exhibit a high porosity. Similarly, due to the random orientation of the fibers, the air laid web may exhibit a high loft. The air laid web may be formed from fibers that cannot be carded (e.g. , short fibers).

[0046] In an embodiment, the nonwoven web of the outer layer 112 may include at least one spunbonded web. The spunbonded web is formed by tangling the fibers before depositing the fibers on a belt. The belt then carries the fibers to a device that bonds (e.g., thermally, mechanically, or chemically bonds) the fibers together. Generally, the fibers are randomly oriented in the spunbonded web though the fibers may be slightly biased in the direction that the belt moves. Due to the random orientation of the fibers, the air laid web tends to be isotropic and exhibit a high porosity. Similarly, due to the random orientation of the fibers, the air laid web may exhibit a high loft. The spunbonded web may exhibit relatively good water absorption. The spunbonded web may exhibit a durability that is less than at least some of the nonwoven webs disclosed herein. In a particular example, the nonwoven web may be a spunbonded web when the outer layer 112 includes bamboo since a spunbonded web including bamboo exhibits better fluid permeability, better wicking, and retains less bodily fluids than if the spunbonded webincluding at least some other materials or the bamboo was included in at least some other nonwoven web.

[0047] In an embodiment, the nonwoven web of the outer layer 112 may include at least one spunlaced web. The spunlaced web is formed by providing a sheet that includes randomly oriented fibers or a carded web. High pressure water jets that are generally parallel to the thickness of the sheet are directed towards the sheet. Similar to the needle punched web, the high pressure jets of water cause some of the fibers to migrate from an exterior of the sheet to an interior thereof to form columns. Thus, the spunlaced web may function similar to the needle punched web, namely that the spunlaced web may be more isotropic than the carded web and includes divots. However, the spunlaced web may exhibit at least one of a density that is less than, a thickness that is greater than, or a basis weight that is less than the needle punched web. As such, the spunlaced web may be more delicate (e.g. , less durable or softer) than the needle punched web. The more delicate spunlaced web may more comfortably contact the skin of the patient than the needle punched web.

[0048] In an embodiment, the nonwoven web of the outer layer 112 may include at least one vertical lapped nonwoven fabric. The vertical lapped nonwoven fabric is formed by lapping a sheet vertically such that a cross-section of the vertical lapped nonwoven fabric taken along a plane that is parallel to the thickness and length of the vertical lapped nonwoven fabric shows a periodic wavy (e.g., sinusoidal) structure. The folds in the sheet cause the fibers of the non wo ven web to be preferentially oriented vertically between the folds and the fibers at the folds to be preferentially oriented horizontally. Thus, the vertically lapped nonwoven fabric causes the bodily fluids to wick both horizontally and vertically. The vertically oriented fibers also cause the vertical lapped nonwoven fabric to be resistant to collapse, even at high vacuum pressures. Similarly, the vertically oriented fibers also cause the vertical lapped nonwoven fabric to exhibit excellent elastic recovery and localized deformation when a force is applied thereto that is generally parallel to the vertically oriented fibers. The elastic recovery and localized deformation minimize the likelihood that the nonwoven material collapses when both a suction force and an external force is applied to the nonwoven web (e.g., laying on or pressing against fluid collection assembly 100) and increases the likelihood that any collapse is localized and temporary. The vertical lapped nonwoven fabric may also exhibit low density and is highly moldable. The verticallapped nonwoven fabric may exhibit any suitable thickness by increasing or decreasing the distance between folds.

[0049] In an embodiment, the nonwoven web of the outer layer 112 may include at least one horizontal lapped nonwoven fabric. The horizontal lapped nonwoven fabric is formed by lapping a sheet horizontally. The folds in the sheet cause the fibers of the nonwoven web to be preferentially oriented horizontally between the folds and the fibers at the folds to be preferentially oriented vertically. Thus, the horizontal lapped nonwoven fabric causes the bodily fluids to wick both horizontally and vertically. The horizontal lapped nonwoven fabric may exhibit high thickness by merely increasing the number of folds formed therein.

[0050] In an embodiment, the nonwoven web of the outer layer 112 may include at least one crossed lapped nonwoven fabric. The crossed lapped nonwoven fabric is substantially similar to the horizontal lapped nonwoven fabric except that each layer is not parallel to the adjacent layers. Instead, each layer extends obliquely relative to the previously layer which causes the crossed lapped nonwoven fabric to exhibit more isotropic properties than the horizontal lapped nonwoven web, especially when the horizontal and crossed lapped nonwoven fabrics are formed from a carded web.

[0051] It is currently believed that the carded web, needle punched web, the air laid web, the spunlaced web, spunbonded web, vertical lapped nonwoven web, horizontal lapped nonwoven web, and the cross lapped nonwoven web, are the preferred nonwoven webs to be included in the outer layer 112. However, it is noted that the outer layer 112 may include one or more nonwoven webs other than the carded web, needle punched web, the air laid web, and the spunlaced web. In an example, the outer layer 112 may include a wet laid web even though the wet laid web may exhibit low durability compared to the other nonwoven webs disclosed herein. In an example, the outer layer 112 may include melt-blown nonwoven webs even though such nonwoven webs may exhibit too low of porosity for some applications.

[0052] In an embodiment, the outer layer 112 may include a woven fabric instead of or in addition to a nonwoven web. Forming the outer layer 112 from a woven material may increase the durability of the porous material 110 than if the outer layer 112 is formed from a nonwoven material. However, forming the outer layer 112 from a woven material may decrease the compressibility of the porous material 110 thereby making the porous material 110 less comfortable and may make conforming the porous material 110 to the vaginal region, which limits leaks, more difficult. Also, it is more difficult to forma woven outer layer 112 than a nonwoven outer layer 112. As such, using the woven outer layer 112 may cause logistic issues, increase manufacturing difficulties, and increase cost. Further, it may be difficult to obtain a woven outer layer 112 exhibiting a sufficiently low basis weight to be effective wherein a nonwoven outer layer 112 exhibiting a sufficiently low basis weight may be easy to obtain.

[0053] The outer layer 112 is disposed on an outer surface of the intermediate layer 114. The bodily fluids received (e.g., directly) by the outer layer 112 flow from the outer layer 112 to the intermediate layer 114. The bodily fluids may flow from the outer layer 112 to the intermediate layer 114 for a variety of reasons. For example, the relatively small thickness of the outer layer 112 only allows the outer layer 112 to hold a relatively small volume of bodily fluids. As such, the outer layer 112 may become quickly saturated with the bodily fluids thereby forcing the bodily fluids to flow from the outer layer 112 to the intermediate layer 114. Further, as will be discussed in more detail below, a suction may be applied to the chamber 104. The suction may cause the bodily fluids to flow from the outer layer 112 into the intermediate layer 114. Additionally, the intermediate layer 114 includes an intermediate hydrophilic material. The hydrophilicity of the intermediate hydrophilic material pulls the bodily fluids from the outer layer 1 12 into the intermediate layer 114. It is noted that the flow of the bodily fluids from the outer layer 112 to the intermediate layer 114 prevents or at least inhibits the bodily fluids that are received into the outer layer 112 from leaking from the outer layer 112. The flow of the bodily fluids from the outer layer 112 to the intermediate layer 114 decreases the volume of bodily fluids that are retained in the outer layer 112 after the patient urinates (i.e., makes the outer layer 112 feel more dry).

[0054] As previously discussed, the intermediate layer 114 may be hydrophilic. For example, the intermediate layer 114 may include an intermediate hydrophilic material that is hydrophilic. The intermediate hydrophilic material may be hydrophilic when the intermediate hydrophilic material exhibits a contact angle with water (a major constituent of bodily fluids) that is about 0° to about 10°, about 5° to about 15°, about 10° to about 20°, about 15° to about 25°, about 20° to about 30°, about 25° to about 35°, about 30° to about 40°, about 35° to about 45°, about 40° to about 50°, about 45° to about 55°, about 50° to about 60°, about 55° to about 65°, about 60° to about 70°, about 65° to about 75°, about 70° to about 80°, about 75° to about 85°, or about 80° to 90°. It is noted that the overall hydrophilicity of the intermediate layer 114 may exhibit any of the above contact angles. Generally, increasing the hydrophilicity of the intermediate hydrophilic material(i.e., decreasing the contact angle between the intermediate hydrophilic material and water) increases the quantity of bodily fluids that the intermediate layer 114 may receive over a certain period of time. However, increasing the hydrophilicity of the intermediate hydrophilic material may increase the quantity of bodily fluids that are retained in the intermediate layer 114 after the intermediate layer 114 receives the bodily fluids. As such, the hydrophilicity of the intermediate hydrophilic material may be selected based on balancing the need to receive bodily fluids quickly while also keeping the porous material 110 dry. That said, the inner, support layer 116 may pull bodily fluids from the intermediate layer 114 regardless of the hydrophilicity of the intermediate hydrophilic material thereby decreasing the amount of bodily fluids that are retained in the intermediate layer 114. Further, the intermediate layer 114 does not directly contact the skin of the patient thereby minimizing the adverse effect any bodily fluids retained in the intermediate layer 114 has on the patient.

[0055] In an embodiment, the overall hydrophilicity of the intermediate layer 114 is greater than the overall hydrophilicity of the outer layer 112. For example, the intermediate layer 114 may exhibit a contact angle with water than is less than the outer layer 1 12, respectively, by about 5° of more, about 10° or more, about 15° or more, about 20° or more, about 25° or more, about 30° or more, about 35° or more, about 40° or more, about 45° or more, about 50° or more, about 60° or more, about 70° or more, about 80° or more, or in ranges of about 5° to about 15°, about 10° to about 20°, about 15° to about 25°, about 20° to about 30°, about 25° to about 35°, about 30° to about 40°, about 35° to about 45°, about 40° to about 50°, about 45° to about 60°, about 50° to about 70°, or about 60° to about 80°. The increased hydrophilicity of the intermediate layer 114 relative to the outer layer 112 causes the intermediate hydrophilic material to pull bodily fluids from the outer layer 112. For example, the increased hydrophilicity of the intermediate layer 114 relative to the outer layer 112 causes the intermediate layer 114 to exhibit a greater affinity for the bodily fluids thereby causing the bodily fluids in the outer layer 112 to preferentially flow to the intermediate layer 114. Due to hydrogen bonding, the bodily fluids that flow into the intermediate layer 114 also pull additional bodily fluids into the intermediate layer 114. The ability of the intermediate layer 114 to pull bodily fluids from the outer layer 112 into the intermediate layer 114 decreases the volume of bodily fluids in the outer layer 112 (i.e., dries the outer layer 112). For example, the intermediate layer 114 may pull sufficient quantities of bodily fluids from the outer layer 112 that the quantities of bodily fluids in the outer layer 112 is negligibleand may be relatively quickly evaporated due to air flow through the outer layer 112 caused by the suction provided to the chamber 104. Further, the increased hydrophilicity of the intermediate layer 114 prevent or at least minimizes backflow of the bodily fluids from the intermediate layer 114 to the outer layer 112.

[0056] In an embodiment, the intermediate layer 114 includes bamboo. Bamboo is a hydrophilic material that exhibits a relatively low contact angle of water. For example, bamboo naturally exhibits a hydrophilicity that is greater than hydrophilic polypropylene and hydrophilic polyethylene. It has also been found that bamboo has a greater synergistic effect with hydrophilic polypropylene and hydrophilic polyethylene than expected. For example, an intermediate layer 114 including bamboo is able to pull a greater percentage of bodily fluids from a hydrophilic polypropylene and / or hydrophilic polyethylene and minimize back flow of bodily fluids from the intermediate layer 114 to the outer layer 112 better than expected.

[0057] The bamboo of the intermediate layer 114 may be formed from any bamboo material. In an example, the intermediate layer 114 is formed from natural bamboo. The natural bamboo may be more ecologically friendly than other bamboo materials and may require less manufacturing than non-natural bamboo. In an example, the intermediate layer 114 may include black bamboo (z.<?., bamboo from phyllostachys nigra). Black bamboo exhibits greater antimicrobial properties than other types of bamboo; though, it is noted, the other types of bamboo also exhibit antimicrobial properties.

[0058] The bamboo of the intermediate layer 114 may include bamboo kun. Bamboo kun is a material naturally found in bamboo. The bamboo kun causes the intermediate layer 114 to exhibit antifungal properties and antibacterial properties against both Grampositive and Gram-negative bacteria. As such, the presence of the bamboo kun in the intermediate layer 114 causes the fluid collection assemblies to be substantially as likely to cause catheter-assisted urinary tract infections (“CAUTI”) as sterilized conventional external fluid collection assemblies without actually sterilizing the fluid collection assemblies. Also, the bamboo kun of the intermediate layer 114 is not vulnerable to attack by infectious microbials that may cause CAUTI. The bamboo kun also causes the intermediate layer 114 to be odor resistant, unlike porous materials used in conventional fluid collection assemblies. The odor resistant abilities of the intermediate layer 114 makes using the fluid collection assemblies including the intermediate layer 114 less embarrassing to use since, unlike conventional fluid collection assemblies, the fluid collection assemblies including the intermediate layer 114 are unlikely to have anoticeable odor of urine or blood. Unlike the porous materials of conventional fluid collection assemblies, the bamboo kun also causes the intermediate layer 114 to repel dust mites, other bugs, other infectious microorganisms, and viruses. The bamboo kun also repeals these organisms while the bamboo that forms the intermediate layer 114 is grown. As such, unlike the materials used to form other natural porous materials (e.g., cotton and cellulose), the bamboo that forms the intermediate layer 114 may be grown without pesticides, fungicides, and insecticides. This results in the intermediate layer 114 to be less likely to be contaminated with pesticides, fungicides, and insecticides compared to other natural porous materials without having to process the intermediate layer 114 to remove such materials. Also, the bamboo kun causes the intermediate layer 114 to be more hypoallergenic than other porous materials used in conventional fluid collection assemblies.

[0059] The intermediate layer 114 may include one or more hydrophilic intermediate materials instead of or in addition to bamboo. In an example, the intermediate layer 114 includes at least one of cotton, rayon, or viscose. In an embodiment, the intermediate layer 114 may be formed from any cellulose-based material. In an example, the intermediate layer 1 14 is formed from naturally derived cellulose which may be more ecologically friendly than other cellulose materials. It has been surprisingly found that cotton, rayon, viscose, and other cellulose -base materials have a more synergistic relationship with the outer layer 112 (e.g., hydrophilic polypropylene and hydrophilic polyethylene) than other hydrophilic materials. The synergistic relationship includes quickly and effectively moving the bodily fluids from the outer layer 112 to the intermediate layer 114. That said, it is currently believed that bamboo is better able to receive bodily fluids from the outer layer 112 and minimize back flow of the bodily fluids than cotton, rayon, viscose, and other cellulose-base materials.

[0060] In an embodiment, the hydrophilicity of the intermediate layer 114 may be an inherent property of the bamboo and some of the other materials disclosed herein that are used to form the intermediate layer 114. In an embodiment, the hydrophilicity of the intermediate layer 114 may be changed (e.g., increased or decreased) by at least one of impurities or functional groups added to the intermediate layer 114, otherwise treating the intermediate layer 114, or coating the intermediate layer 114 with a material that exhibits a hydrophilicity that is different than the intermediate layer 114. It is noted that the hydrophilicity of the intermediate layer 114 may depend on the temperature, humidity,and other factors and that the hydrophilicity of the materials disclosed herein are measured at room temperature, at sea level, and at a humidity of 30-50%.

[0061] The intermediate layer 114 of the porous material 110 may be selected to exhibit a density of about 50 kg / m3to about 100 kg / m3, about 75 kg / m3to about 125 kg / m3, about 100 kg / m3to about 150 kg / m3, about 125 kg / m3to about 175 kg / m3, about 150 kg / m3to about 200 kg / m3, about 175 kg / m3to about 225 kg / m3, about 200 kg / m3to about 250 kg / m3, about 225 kg / m3to about 275 kg / m3, about 250 kg / m3to about 300 kg / m3, about 275 kg / m3to about 325 kg / m3, about 300 kg / m3to about 350 kg / m3, about 325 kg / m3to about 375 kg / m3, about 350 kg / m3to about 400 kg / m3, about 375 kg / m3to about 425 kg / m3, about 400 kg / m3to about 450 kg / m3, about 425 kg / m3to about 475 kg / m3, about 450 kg / m3to about 500 kg / m3, about 475 kg / m3to about 525 kg / m3, about 500 kg / m3to about 550 kg / m3, about 525 kg / m3to about 575 kg / m3, or about 550 kg / m3to about 600 kg / m3.

[0062] As previously discussed, the intermediate layer 114 may be formed from a hydrophilic material which may cause the intermediate layer 114 to retain the bodily fluids therein. To decrease the quantity of bodily fluids retained by the intermediate layer 1 14, the intermediate layer 114 may be configured to be relatively thin. For example, the intermediate layer 114 may be configured to exhibit a thickness measured perpendicularly to the longitudinal axis 130 (e.g., measured radially) that is about 2 mm or less, about 1.5 mm or less, about 1.25 mm or less, about 1 mm or less, about 800 pm or less, about 700 pm or less, about 600 pm or less, about 500 pm or less, about 400 pm or less, about 300 pm or less, about 250 pm or less, about 200 pm or less, about 150 pm or less, about 130 pm or less, about 100 pm or less, about 75 pm or less, about 60 pm or less, about 50 pm or less, about 40 pm or less, about 30 pm or less, about 25 pm or less, about 20 pm or less, or in ranges of about 20 pm to about 30 pm, about 25 pm to about 40 pm, about 30 pm to about 50 pm, about 40 pm to about 60 pm, about 50 pm to about 75 pm, about 60 pm to about 100 pm, about 75 pm to about 130 pm, about 100 pm to about 150 pm, about 130 pm to about 200 pm, about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to about 600 pm, about 500 pm to about 700 pm, about 600 pm to about 800 pm, about 700 pm to about 1 mm, about 800 pm to about 1.25 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm. The relatively small thickness of the intermediate layer 114 decreases the overall volume of the intermediate layer 114 thereby decreasing the volume of bodily fluids that may be retained in the intermediate layer 114. The decreasing volume of bodily fluids heldwithin the intermediate layer 114 allows air flow through the chamber 104 to quickly evaporate the bodily fluids that are retained in the intermediate layer 114 (i.e., the bodily fluids that failed to transfer from the intermediate layer 114 to the intermediate layer 114) thereby maintaining the porous material 110 dry. Further, decreasing the thickness of the intermediate layer 114 may allow the intermediate layer 114 to pull more bodily fluids from the intermediate layer 114.

[0063] The intermediate layer 114 of the porous material 110 may be selected to exhibit a basis weight of about 15 gsm to about 25 gsm, about 10 gsm to about 20 gsm, about 15 gm / m2to about 25 gsm, about 20 gsm to about 30 gsm, about 25 gsm to about 35 gsm, about 30 gsm to about 40 gsm, about 35 gsm to about 45 gsm, about 40 gsm to about 50 gsm, about 45 gsm to about 55 gsm, about 50 gsm to about 60 gsm, about 55 gsm to about 70 gsm, about 60 gsm to about 80 gsm, about 70 gsm to about 90 gsm, about 80 gsm to about 100 gsm, about 90 gsm to about 120 gsm, or about 105 gsm to about 130 gsm. In a particular embodiment, the intermediate layer 114 exhibits a basis weight of about 25 gsm to about 65 gsm. The basis weight of the intermediate layer 114 is a function of the density and thickness of the intermediate layer 114. As such, the basis weight of the intermediate layer 1 14 may be selected for any of the same reasons as the density and thickness of the intermediate layer 114. It is noted that the surface area of the intermediate layer 114 depends, in part, on the basis weight thereof. As such, increasing the basis weight of the intermediate layer 114 (to an extent) may increase the surface area of the intermediate layer 114. How quickly the intermediate layer 114 is able to pull bodily fluids into itself from the outer layer 112 depends, in part, on the surface area thereof. However, increasing the basis weight of the intermediate layer 114 may decrease the volume of the void space of the intermediate layer 114 that may temporarily hold the bodily fluids therein. As such, the basis weight of the intermediate layer 114 may be selected by balancing these factors.

[0064] As previously discussed, the intermediate layer 114 is formed from a plurality of fibers. The plurality of fibers may exhibit an average length, an average lateral dimension, and an average aspect ratio. The average length, average lateral dimension, and average aspect ratio of the intermediate layer 114 may be selected to exhibit any of the average lengths, average lateral dimensions, and average aspect ratios disclosed herein. The average length, average lateral dimension, and average aspect ratio of the intermediate layer 114 may be selected for any of the same reasons as the average length, average lateral dimension, and average aspect ratio of the outer layer 112.

[0065] The intermediate layer 114 may include any of the nonwoven or woven fabrics disclosed herein.

[0066] The intermediate layer 114 may be disposed on an outer surface of the inner, support layer 116. The inner, support layer 116 is configured to support the outer layer 112 and the intermediate layer 114 since the outer layer 112 and the intermediate layer 114 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the inner, support layer 116 may be positioned such that the outer layer 112 and the intermediate layer 114 are disposed between the inner, support layer 116 and the fluid impermeable barrier 102. As such, the inner, support layer 116 may support and maintain the position of the outer layer 112 and the intermediate layer 114. The inner, support layer 116 may include any hydrophobic material. In an example, the inner, support layer 116 may include any other suitable hydrophobic material (e.g., spun nylon fiber, a gauze, a polyurethane foam, a polyethylene foam, hydrophobic polypropylene, hydrophobic polyethylene, or a polyvinyl chloride foam) instead of or in addition to hydrophobic polypropylene or hydrophobic polyethylene. The inner, support layer 116 may include a plurality of fibers formed into a nonwoven material (e.g., any of the nonwoven materials disclosed herein), a woven material, or an open cell foam.

[0067] In an embodiment, the inner, support layer 116 may be configured to move any bodily fluids away from the intermediate layer 114, thereby preventing the bodily fluids from escaping the chamber 104. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the inner, support layer 116 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 inner, support layer 116 (e.g., absorbency), such as less than about 30 wt% of the dry weight of the inner, support layer 116, less than about 20 wt%, less than about 15 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 intermediate layer 114. The inner, support layer 116 may also wick the bodily fluids generally towards an interior of the chamber 104, as discussed in more detail below.

[0068] In an embodiment, at least a portion of the inner, support layer 116 may be hydrophobic or at least more hydrophobic than the intermediate layer 114. The inner, support layer 116 may be hydrophobic when the inner, support layer 116 exhibits acontact 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 inner, support layer 116 may limit absorption, adsorption, and solubility of the bodily fluids in the inner, support layer 116 thereby decreasing the amount of bodily fluids held in the inner, support layer 116. The lower hydrophilicity of the outer layer 112 and the intermediate layer 114 may help the porous material 110 receive the bodily fluids from the urethral opening while the hydrophobicity of the inner, support layer 116 limits the bodily fluids that are retained in the porous material 110.

[0069] The hydrophobicity of the inner, support layer 116 facilitates flow of the bodily fluids from the outer layer 112 and the intermediate layer 114 towards the fluid outlet 108 (<?.g., towards an inlet of the conduit 126 positioned through the fluid outlet 108). For example, some of the bodily fluids that are received by the intermediate layer 114 flow into the inner, support layer 116. The bodily fluids may flow from the intermediate layer 114 to the inner, support layer 116 because, for example, the bodily fluids are already flowing from the outer layer 112 into the intermediate layer 114 and the suction provided to the chamber 104 causes the bodily fluids to preferentially flow from the intermediate layer 114 towards the inner, support layer 116. The hydrophobicity of the inner, support layer 116 discourages the bodily fluids from remaining in the inner, support layer 116 which, in turn, pushes the bodily fluids towards the fluid outlet 108. However, the bodily fluids received into the inner, support layer 116 are still hydrogen bonded to the bodily fluids in the intermediate layer 114. As such, the inner, support layer 116 pulls bodily fluids from the intermediate layer 114 into the inner, support layer 116 as the inner, support layer 116 pushes the bodily fluids towards the fluid outlet 108. The ability of the inner, support layer 116 to pull bodily fluids into itself decreases the quantity of bodily fluids that are retained in the intermediate layer 114 (even when the intermediate layer 114 includes bamboo) can cause the intermediate layer 114 to more effectively pull bodily fluids into itself from the outer layer 112. Thus, the inner, support layer 116 effectively decreases the quantity of bodily fluids that are retained in the porous material 110 after urination.

[0070] It is noted that the intermediate layer’s 114 ability to pull bodily fluids from the outer layer 112 and move the bodily fluids into the inner, support layer 116 are different. For example, the intermediate layer 114 uses a hydrophilic-hydrophilic interaction between the outer layer 112 and the intermediate layer 114 to move bodilyfluids from the outer layer 112 to the intermediate layer 114 and a hydrophilic- hydrophobic interaction between the intermediate layer 114 and the inner, support layer 116 to move the bodily fluids from the intermediate layer 114 to the inner, support layer 116. It is surprising that the intermediate layer 114 is able to effectively cause bodily fluids to flow effectively through the porous material 110 even though the intermediate layer 114 using two different interactions. Further, it is currently believed that the cellulose materials disclosed herein, and in particular bamboo, have a more effective hydrophilic -hydrophobic interaction with the inner, support layer 116 (z.<?., are able to more effectively move bodily fluids from the intermediate layer 114 to the inner, support layer 116) than other hydrophilic materials.

[0071] The inner, support layer 116 may exhibit a thickness (e.g. , radius and / or diameter) that is about 100 pm to about 150 pm, about 130 pm to about 200 pm, about 150 pm to about 300 pm, about 200 pm to about 400 pm, about 300 pm to about 500 pm, about 400 pm to about 600 pm, about 500 pm to about 700 pm, about 600 pm to about 800 pm, about 700 pm to about 1 mm, about 800 pm to about 1.25 mm, about 1 mm to about 4 mm, about 2 mm to about 6 mm about 4 mm to about 8 mm, about 6 mm to about 10 mm, about 8 mm to about 12 mm, about 10 mm to about 14 mm, about 12 mm to about 16 mm, about 14 mm to about 18 mm, about 16 mm to about 20 mm, about 18 mm to about 22 mm, or about 20 mm to about 25 mm. Generally, increasing the thickness of the inner, support layer 116 increases the quantity of bodily fluids that may be temporarily stored therein and may flow therethrough thereby decreasing the likelihood that the fluid collection assembly 100 leaks. However, increasing the thickness of the inner, support layer 116 may dilute any suction force applied to the chamber 104 and may make it difficult to position the fluid collection assembly 100 between the legs of the patient.

[0072] In an embodiment, the thickness of the inner, support layer 116 may be greater than the thickness of the outer layer 112. Generally, decreasing the thickness of the outer layer 112 decreases the volume of bodily fluids that may be stored in the outer layer 112 and decreases the volume of bodily fluids that the inner, support layer 116 may pull from the outer layer 112. Also, increasing the thickness of the inner, support layer 116 may increase the ability of inner, support layer 116 to promote flow of the bodily fluids towards to the fluid outlet 108 e.g., towards an inlet of the conduit 126).

[0073] In an embodiment, the inner, support layer 116 includes at least one inner porous material. In an example, the inner porous material 116 includes at least one of avertical lapped nonwoven material, another nonwoven material, a woven material, spun nylon fibers, a polyurethane foam, a polyvinyl chloride foam, a polyethylene foam, a hydrophobic polypropylene, or hydrophobic polyethylene. In an example, the inner porous material 116 includes one of the porous materials (e.g., a porous material including a first layer, a second layer, and a plurality of fibers extending between the first and second layers, wherein the first and second layers may include a woven material) disclosed in U.S. Patent Application No. 18 / 164,800 filed on February 6, 2023, the disclosure of which is incorporated herein, in its entirety, by this reference The inner porous material is able to quickly receive bodily fluids from the individual, even when the individual discharges a large quantity of bodily fluids over a short period of time. In an example, the inner porous material may facilitate moving the bodily fluids through the chamber 104 of the fluid collection assembly 100 and towards an outlet (<?.g.4the fluid outlet 108 or an inlet of a conduit 126 disposed through the fluid outlet 108) which allows the porous material 110 to remain dry. Further, it has been surprisingly found that the bodily fluids received into the outer layer 112 may flow easily from the outer layer 112 into the inner porous material and the inner porous material pulls bodily fluids from the outer layer 112 that would otherwise remain in the polyurethane foam.

[0074] When the inner porous material includes a foam (i.e., at least one of the polyurethane foam, the polyethylene foam, or the polyvinyl chloride foam), the inner porous material may exhibit about 5 pores / cm2to about 20 pores / cm2, such as about 5 pores / cm2to about 7 pores / cm2, about 6 pores / cm2to about 8 pores / cm2, about 7 pores / cm2to about 9 pores / cm2, about 8 pores / cm2to about 10 pores / cm2, about 9 pores / cm2to about 11 pores / cm2, about 10 pores / cm2to about 12 pores / cm2, about 11 pores / cm2to about 13 pores / cm2, about 12 pores / cm2to about 14 pores / cm2, about 13 pores / cm2to about 15 pores / cm2, about 14 pores / cm2to about 16 pores / cm2, about 15 pores / cm2to about 17 pores / cm2, about 16 pores / cm2to about 18 pores / cm2, about 17 pores / cm2to about 19 pores / cm2, or about 18 pores / cm2to about 20 pores / cm2.Generally, increasing the number of pores / cm2of the foam increases the number of interconnected pores formed in the porous material, increases the quantity of bodily fluids that may be stored in the foam, and the quantity of and rate at which the bodily fluids may flow through the foam. However, increasing the number of pores / cm2decreases the strength of the foam. As such, the number of pores / cm2of the foam may be selected based on balancing these factors.

[0075] The inner porous material may exhibit a density of about 100 g / m2 / cm to about 250 g / m2 / cm, such as about 130 g / m2 / cm to about 240 g / m2 / cm, about 100 g / m2 / cm to about 140 g / m2 / cm, about 120 g / m2 / cm to about 160 g / m2 / cm, about 140 g / m2 / cm to about 180 g / m2 / cm, about 160 g / m2 / cm to about 200 g / m2 / cm, about 180 g / m2 / cm to about 220 g / m2 / cm, or about 200 g / m2 / cm to about 250 g / m2 / cm. Generally, increasing the density of the inner porous material increases the strength of the inner porous material. However, increasing the density of the inner porous material may decrease the porosity of the inner porous material which decreases the quantity of bodily fluids that may be temporarily stored in the porous material 110 and decrease the flow rate of the bodily fluids through the inner porous material. As such, the density of the inner porous material may be selected based on balancing the desired strength, porosity, and flow rate of the bodily fluids through the inner porous material.

[0076] When the inner porous material includes a vertical lapped nonwoven material, the inner porous material may exhibit a density of about 50 kgsm-cm or greater, about 75 kgsm-cm or greater, about 100 kgsm-cm or greater, about 125 kgsm-cm or greater, about 150 kgsm-cm or greater, about 175 kgsm-cm or greater, about 200 kgsm-cm or greater, about 250 kgsm-cm or greater, about 300 kgsm-cm or greater, or in ranges of about 50 kgsm-cm to about 100 kgsm-cm, about 75 kgsm-cm to about 125 kgsm-cm, about 100 kgsm-cm to about 150 kgsm-cm, about 125 kgsm-cm to about 175 kgsm-cm, about 150 kgsm-cm to about 200 kgsm-cm, about 175 kgsm-cm to about 250 kgsm-cm, or about 200 kgsm-cm to about 300 kgsm-cm. Generally, increasing the density of the inner porous material increases the strength of the inner porous material. However, increasing the density of the inner porous material may decrease the porosity of the inner porous material which decreases the quantity of bodily fluids that may be temporarily stored in the porous material 110 and decrease the flow rate of the bodily fluids through the inner porous material. As such, the density of the inner porous material may be selected based on balancing the desired strength, porosity, and flow rate of the bodily fluids through the inner porous material.

[0077] The inner, support layer 116 may exhibit a basis weight of about 2 gsm to about 5 gsm, about 4 gsm to about 7.5 gsm, about 5 gsm to about 10 gsm, about 7.5 gsm to about 12.5 gsm, about 10 gsm to about 15 gsm, about 12.5 gsm to about 20 gsm, about 15 gsm to about 25 gsm, about 20 gsm to about 30 gsm, about 25 gsm to about 35 gsm, about 30 gsm to about 40 gsm, about 35 gsm to about 45 gsm, about 40 gsm to about 50 gsm, about 45 gsm to about 55 gsm, or about 50 gsm to about 60 gsm. The basis weightof the inner, support layer 116 is a function of the density and thickness of the inner, support layer 116. As such, the basis weight of the inner, support layer 116 may be selected for any of the same reasons as the density and thickness of the inner, support layer 116. Generally, the basis weight of the inner, support layer 116 is selected to be less than the basis weight of the outer layer 112. The lower basis weight of the inner, support layer 116 increases the void space in the inner, support layer 116 which facilitate flowing the bodily fluids therethrough (e.g., towards the fluid outlet 108) whereas the greater basis weight of the outer layer 112 may increase the surface area thereof.

[0078] In a particular example, the porous material 110 includes an outer layer 112 including hydrophobic polypropylene or hydrophobic polyethylene, an intermediate layer 114 including bamboo, and an inner support layer 116 including polyurethane, polyether, nylon, or hydrophobic polypropylene. In a particular example, the porous material 110 includes an outer layer 112 including hydrophobic polypropylene or hydrophobic polyethylene, an intermediate layer 114 including bamboo, and an inner support layer 116 including a nonwoven material (e.g., a vertical lapped nonwoven material). In a particular example, the porous material 110 includes an outer layer 112 including hydrophobic polypropylene or hydrophobic polyethylene, an intermediate layer 114 including bamboo, and an inner support layer 116 including a first layer, a second layer, and a plurality of fibers extending between the first and second layers, wherein the first and second layers may include a woven material. It is currently believed that these particular porous materials 110 may exhibit a relatively good synergistic relationship compared to other porous materials.

[0079] As previously discussed, the porous material 110 includes a first bonding layer 118 e.g., porous bonding layer) between the outer layer 112 and the intermediate layer 114 and a second bonding layer 120 between the intermediate layer 114 and the inner, support layer 116. The first bonding layer 118 bonds the outer layer 112 and the intermediate layer 114 together such that substantially no air gaps form therebetween. The second bonding layer 120 bonds the intermediate layer 114 and the inner, support layer 116 together such that substantially no air gaps form therebetween. For example, the first and second bonding layers 118, 120 may prevent or at least inhibit air gaps from forming between the layers of the porous material 110 even during prolonged use of the fluid collection assembly 100, when the fluid collection assembly 100 is bent, or even when the outer layer 112 accidently rips. The first and second bonding layers 118, 120 may include any suitable material that bonds the layers of the porous material 110together. In an example, the first bonding layer 120 and / or the second bonding layer 120 includes a hot melt adhesive or any other suitable adhesive. In an example, the outer layer 112 and the intermediate layer 114 and / or the intermediate layer 114 and the inner, support layer 116 are ultrasonically welded together. In such an example, the first bonding layer 118 and / or the second bonding layer 120 includes the portions of the layers of the porous material 110 that are welded together.

[0080] The first bonding layer 118 is only positioned between a portion of the outer layer 112 and the intermediate layer 114 and the second bonding layer 120 is only positioned between a portion of the intermediate layer 114 and the inner, support layer 116. For example, the first and second bonding layers 118, 120 may be positioned between about 10% to about 80% of the surface area of the adjacent layers of the porous material 110, such as about 10% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%, or about 60% to about 80%. Positioning the first and second bonding layers 118, 120 between a portion of the adjacent layers allows holes to be present in the first and second bonding layers 118, 120. The bodily fluids may flow between the layers of the porous material 110 through the holes in the first and second bonding layers 1 18, 120. It is noted that the first bonding layer 118 and / or the second bonding layer 120 may form a plurality of patches. At least some of the patches formed by the bonding layers 118, 120 may be interconnected or not interconnected (z.<?., spaced from each other).

[0081] In an embodiment, one or more layers of the porous material 110 may be omitted. For example, one or more of the outer layer 112, the intermediate layer 114, or the inner, support layer 116 may be omitted. The thicknesses of the layers of the porous material 110 may be adjusted when one or more layers are omitted. For example, the thickness of the intermediate layer 114 may be increased to extend from the conduit 126 to the outer layer 112 when the inner, support layer 116 is omitted. In an embodiment, the porous material 110 may include one or more additional layers (not shown), such as a thin layer on the outer layer 112 that is more comfortable than the outer layer 112.

[0082] The porous material 110 may at least substantially completely fill the portions of the chamber 104 that are not occupied by the conduit 126. In some examples, the porous material 110 may not substantially completely fill the portions of the chamber 104 that are not occupied by the conduit 126. In such an example, the fluid collection assembly 100 includes the reservoir 128 disposed in the chamber 104.

[0083] The reservoir 128 is a substantially unoccupied portion of the chamber 104. The reservoir 128 may be defined between the fluid impermeable barrier 102 and porous material 110. The bodily fluids that are in the chamber 104 may flow through the porous material 110 to the reservoir 128. The reservoir 128 may retain the bodily fluids therein.

[0084] The bodily fluids that are in the chamber 104 may flow through the porous material 110 to the reservoir 128. The fluid impermeable barrier 102 may retain the bodily fluids in the reservoir 128. While depicted in the distal end region 122, the reservoir 128 may be located in any portion of the chamber 104 such as the proximal end region 124. The reservoir 128 may be located in a portion of the chamber 104 that is designed to be located in a gravimetrically low point of the fluid collection assembly when the fluid collection assembly is worn.

[0085] 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 104 closest to the inlet of the conduit 126 (e.g., distal end region 122) and a second reservoir that is located at the portion of the chamber 104 that is at or near proximal end region 124. In another example, the porous material 110 is spaced from at least a portion of the conduit 126, and the reservoir 128 may be the space between the porous material 110 and the conduit 126.

[0086] The conduit 126 may be at least partially disposed in the chamber 104. The conduit 126 may be used to remove the bodily fluids from the chamber 104. The conduit 126 includes at least one wall defining an inlet, an outlet (not shown) 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 104 through the conduit 126. For example, the conduit 126 may extend into the fluid impermeable barrier 102 from the proximal end region 124 and may extend to the distal end region 122 to a point proximate to the reservoir 128 therein such that the inlet is in fluid communication with the reservoir 128. The conduit 126 fluidly couples the chamber 104 with the fluid storage container (not shown) or the vacuum source (not shown).

[0087] The conduit 126 may extend through a bore in the porous material 110. In an embodiment, the conduit 126 extends from the fluid outlet 108, through the bore, to a location that is proximate to the reservoir 128. In such an embodiment, the inlet may not extend into the reservoir 128 and, instead, the inlet may be disposed within the porous material 110 or at a terminal end thereof. For example, an end of the conduit 126 may be co-extensive with or recessed within the porous material 110. In an embodiment, theconduit 126 is at least partially disposed in the reservoir 128 and the inlet may be extended into or be positioned in the reservoir 128. The bodily fluids collected in the fluid collection assembly 100 may be removed from the chamber 104 via the conduit 126.

[0088] Locating the inlet at or near a location expected to be the gravimetrically low point of the chamber 104 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 110 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 110 is saturated with the bodily fluids. Accordingly, one or more of the inlet or the reservoir 128 may be located in the fluid collection assembly 100 in a position expected to be the gravimetrically low point in the fluid collection assembly 100 when worn by an individual, such as the distal end region 122.

[0089] The inlet and the outlet of the conduit 126 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 104 (e.g., the reservoir 128). As the vacuum source (FIG. 6) applies a suction force in the conduit 126, the bodily fluids in the chamber 104 (e.g., at the distal end region 122 such as in the reservoir 128) may be drawn into the inlet and out of the fluid collection assembly 100 via the conduit 126. In some examples, the conduit 126 may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.

[0090] As previously discussed, the conduit 126 may be configured to be at least insertable into the chamber 104. In an example, the conduit 126 may be positioned in the chamber 104 such that a terminal end of the conduit 126 is spaced from the fluid impermeable barrier 102 or other components of the fluid collection assembly 100 that may at least partially obstruct or block the inlet. Further, the inlet of the conduit 126 may be offset relative to a terminal end of the porous material 110 such that the inlet is closer to the proximal end region 124 of the fluid collection assembly 100 than the terminal end of the porous material 110. Offsetting the inlet in such a manner relative to the terminal end of the porous material 110 allows the inlet to receive bodily fluids directly from the porous material 110 and, due to hydrogen bonding, pulls more bodily fluids from the porous material 110 into the conduit 126.

[0091] FIG. ID is a schematic illustration of a system 150 configured to form the porous material 110, according to an embodiment. The system 150 includes a first roll152, a second roll 154, and a third roll 156. The first roll 152 includes and is a source of the hydrophilic outer material of the outer layer 112. The second roll 154 includes and is a source of the hydrophilic intermediate material of the intermediate layer 114. The third roll 156 includes and is a source of the inner porous material of the inner, support layer 116. The system 150 may further include at least one of a fourth roll 158 and a fifth roll 160. The fourth and fifth rolls 158, 160 may include an adhesive material (e.g. , hot melt adhesive, polyurethane, polyether, or acrylic) when the first and second bonding layers 118, 120 are formed from a porous adhesive material.

[0092] The system 150 is configured to position the outer layer 112 adjacent to the intermediate layer 114 and the intermediate layer 114 adjacent to the inner, support layer 116. In other words, the system 150 is configured to position the intermediate layer 114 between the outer layer 112 and the inner, support layer 116. The second roll 154 may be positioned between the first roll 152 and the third roll 156. Such position of the second roll 154 allows the hydrophilic intermediate material to be positioned between the hydrophilic outer material and the inner porous material when the porous material 110 is formed.

[0093] When the system 150 includes the fourth and / or fifth rolls 158, 160, the system 150 may also be configured to position the first bonding layer 118 between the outer layer 112 and the intermediate layer 114 and the second bonding layer 120 between the intermediate layer 114 and the inner, support layer 116. For example, the fourth roll 158 may be positioned between the first and second rolls 152, 154 and / or the fifth roll 160 may be positioned between the second roll 154 and the third roll 156.

[0094] The system 150 may pull the materials from the rolls to form the porous material 110 using any suitable technique. In an example, as illustrated, the system 150 may include one or more rollers 162. The roller 162 may rotate and, responsive to the rotation thereof, pull the materials from the rolls to form the porous material 110. The rollers 162 may allow each of the layers to be simultaneously or substantially simultaneously positioned adjacent to each other. The system 150 including the rollers 162 may pull the layers into the rollers 162 and form the porous material 110 at a rate of about 15 cm / minute to 300 cm / minute, such as in ranges of about 15 cm / minutes to about 50 cm / minutes, about 25 cm / minute to about 75 cm / minute, about 50 cm / minute to about 100 cm / minute, about 75 cm / minute to about 125 cm / minute, about 100 cm / minute to about 150 cm / minutes, about 125 cm / minute to about 200 cm / minute, about 150 cm / minute to about 250 cm / minute, or about 200 cm / minute to about 300 cm / minute. Inan example, the system 150 may include a conveyor belt and one or more of the layers may be positioned sequentially on the conveyor belt (e.g., the inner, support layer 116 may be positioned on the conveyor belt, the first bonding layer 118 may be positioned on the inner, support layer 116, the intermediate layer 114 may be positioned on the first bonding layer 118, and so forth) to form the porous material 110.

[0095] The layers of the porous material 110 may be attached to each other using any suitable technique. In an embodiment, as shown, the rollers 162 may be configured to attach the layers of the porous material 110 together. In an example, the first and second bonding layers 118, 120 may include a heat-activated adhesive (e.g., a hot melt adhesive). In such an example, one or more of the rollers 162 may be heated such that passing the layers of the porous material 110 adjacent to the heated roller 162 activates the heat- activated adhesive. The temperature of the heated rollers 162 may depend on the composition of the heat-activated adhesive. In a particular example, the heated rollers 162 may exhibit a temperature of about 140 °C to about 180 °C since such temperature are able to activate some hot melt adhesives without damaging the hydrophilic polypropylene and / or hydrophilic polyethylene outer layer 112 or the bamboo intermediate layer 1 14. In an example, the first and second bonding layers 1 18, 120 may include a pressure-activated adhesive and passing the layers of the porous material 110 adjacent to the roller 162 provides the pressure that activates the adhesive. In an embodiment, the first and second bonding layers 118, 120 are formed using an ultrasonic weld, a radio frequency weld, or any other suitable weld.

[0096] In an embodiment, the system 150 forms a porous material 110 that is a long, continuous sheet. In such an embodiment, the system 150 may include cutting the long, continuous porous material 110 to form a plurality of porous materials 110 that are sized to fit in the chamber 104. For example, the system 150 may cut the continuous porous materials 110 into a plurality of porous materials 110 exhibiting a length of about 10 cm to about 30 cm (e.g., about 10 cm to 20 cm, about 15 cm to about 25 cm, or about 20 cm to about 30 cm) and a width of about 4 cm to about 12 cm (e.g., about 4 cm to about 8 cm, about 6 cm to about 10 cm, or about 8 cm to about 12 cm).

[0097] As shown in FIGS. 1A-1C, the porous material 110 may exhibit a generally cylindrical shape when disposed in the chamber 104. However, the porous material 110 illustrated in FIG. ID may exhibit a sheet- like shape. As such, the porous material 110 illustrated in FIG. ID may need to be shaped to exhibit a generally cylindrical shape. For example, opposing longitudinal edges of the porous material 110 illustrated in FIG. IDmay be brought together to form the porous material 110 into a generally cylindrical shape. The opposing longitudinal edges of the porous material 110 may be bonded together using any suitable technique such that the porous material 110 maintains the generally cylindrical shape without needing the porous material 110 to be disposed in the chamber 104. In an example, the longitudinal edges of the porous material 110 may be bonded together using a bar sealer, using one or more heated wires, or any other suitable technique.

[0098] FIG. 2A is an isometric view of a fluid collection assembly 200, according to an embodiment. FIG. 2B is a cross-sectional schematic of the fluid collection assembly 200 taken along plane 2B-2B shown in FIG. 2A. The fluid collection assembly 200 is an example of a female fluid collection assembly for receiving and collecting bodily fluids from a female. Except as otherwise disclosed herein, the fluid collection assembly is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 200 includes a fluid impermeable barrier 202 that is the same or similar to any of the fluid impermeable barriers disclosed herein in one or more aspects. The fluid impermeable barrier 202 at least defines a chamber 204, at least one opening 206, and a fluid outlet 208. The fluid collection assembly 200 also includes at least one porous material 210 positioned within the chamber 204. The porous material 210 may be the same or similar to any of the porous materials disclosed herein in one or more aspects (e.g., the porous material 210 includes an outer layer 212, an intermediate layer 214, an inner, support layer 216, a first bonding layer 218, and a second bonding layer 220). The fluid collection assembly 200 may also include at least one conduit 226 partially positioned within the fluid outlet 208 that is configured to remove one or more bodily fluids from the chamber 204. The conduit 226 may not extend through the porous material 210.

[0099] In an embodiment, the fluid impermeable barrier 202 may include a shell 232 and a connector piece 234 secured to the shell 232. The shell 232 of the fluid collection assembly 200 includes a proximal end region 224, a distal end region 222 opposite the proximal end region 224, a front side 236, and a back side 238 opposite the front side 236. Generally, during use, the distal end region 222 is closer to the gluteal cleft of the individual than the proximal end region 224 and the front side 236 generally faces the vaginal region of the individual. The shell 232 may be formed from silicone, neoprene, a thermoplastic elastomer, or other fluid impermeable materials.

[0100] In an embodiment, the shell 232 includes one or more flanges. The flanges may provide more locations for underwear or other clothing to contact and press against the fluid collection assembly 200 which may facilitate securing the fluid collection assembly 200 to the vaginal region of the individual and may improve patient comfort. In an embodiment, the flanges may include at least one of an upper flange 240 forming the proximal end region 224 and a bottom flange 242 opposite the upper flange 240 that forms the distal end region 222.

[0101] The flanges of the body may extend from the rest of the shell 232 by a distance that is about 1 mm or greater, about 2 mm or greater, about 3 mm or greater, about 4 mm or greater, about 5 mm or greater, about 6 mm or greater, about 7.5 mm or greater, about 1 cm or greater, about 1.25 cm or greater, about 1.5 cm or greater, about 2 cm or greater, about 2.5 cm or greater, about 3 cm or greater, about 4 cm or greater, about 5 cm or greater, or in ranges of about 1 mm to about 3 mm, about 1 mm to about 4 mm, about 3 mm to about 5 mm, about 4 mm to about 6 mm, about 5 mm to about 7.5 mm, about 6 mm to about 1 cm, about 7.5 mm to about 1.25 cm, about 1 cm to about 1.5 cm, about 1.25 cm to about 1 cm, about 1.5 cm to about 1.5 cm, about 1 cm to about 3 cm, about 1.5 cm to about 4 cm, or about 3 cm to about 5. The distance that the flanges extend from the rest of the shell 232 may be selected based on the expected size of the vaginal region of the individual (e.g., larger flanges for a larger vaginal region) or the expected rotational forces applied to the fluid collection assembly 200 during use. In some examples, at least some of the flanges may extend further from the rest of the shell 232 that other flanges. For instance, as illustrated, the bottom flange 242 may extend further from the rest of the fluid impermeable barrier 202 than the upper flange 240 since some individuals may find the longer bottom flange 242 more comfortable.

[0102] In an embodiment, the one or more flanges may exhibit a concave curve relative to the front side 236 of the shell 232. The concave curve of the flanges may extend from the proximal end region 224 to the distal end region 222. The concave curve of the flanges may allow the flanges to better conform to the shape of the vaginal region since the vaginal region is curved. Conforming the flanges to the shape of the vaginal region may make the fluid collection assembly 200 more comfortable by more uniformly distributing pressure across the vaginal region, especially when the flanges contact the labia majora.

[0103] In an embodiment, the shell 232 may include a sump 244 at or near the distal end region 222. The sump 244 may extend outwardly from the front side 236 of the shell232. During use, the sump 244 is configured to be at, near, or otherwise in fluid communication with a gravimetric low point of the porous material 210. For example, the sump 244 may receive a portion of the porous material 210 therein. The sump 244 may receive at least some of the bodily fluids that are received by the porous material 210. The sump 244 may prevent or at least inhibit bodily fluids from leaking from the fluid collection assembly 200. The sump 244 may include at least a portion of the connector piece 234 at least partially disposed therein.

[0104] In an embodiment, the shell 232 may define a recess that is configured to receive a conduit 226. The recess may extend from or near the proximal end region 224 to or near the distal end region 222 thereby allowing the conduit 226 to extend from or near the individual’s abdominal region to the connector piece 234. In an embodiment, the recess may be configured such that the shell 232 encloses and / or abuts less than 50% of a circumference of the conduit 226, thereby allowing the conduit 226 to freely enter and leave the recess during use. Allowing the conduit 226 to freely enter and leave the recess may facilitate positioning of the fluid collection assembly 200 such that the porous material 210 is adjacent to the vaginal region even when the conduit 226 is bending away from the vaginal region. Also, allowing the conduit 226 to freely enter and leave the recess may increase the likelihood that movement of the conduit 226 does not move the porous material 210 relative to the vaginal region since movement of the porous material 210 may cause leaking. In an embodiment, at least a portion of the recess may be configured such that the shell 232 encloses and / or abuts more than 50% (e.g., 51% to about 55%, about 53% to about 57%, or about 55% to about 60%) of the circumference of the conduit 226. Enclosing more than 50% of the circumference of the conduit 226 may more securely attach the conduit 226 to the shell 232 and may allow the conduit 226 to provide additional structure to the shell 232. The percentage of the conduit 226 enclosed and / or abutted by the shell 232 may be selected such that the inherent elasticity of the shell 232 and the conduit 226 allows the conduit 226 to be easily snapped into and out of the recess. As such, the conduit 226 may be removed from the recess to facilitate positioning the porous material 210 adjacent to the vaginal region or when the conduit 226 is moved.

[0105] As previously discussed, the fluid impermeable barrier 202 includes a connector piece 234 that is attached to (e.g., with an adhesive, welding, interference fit, etc.) or integrally formed with the shell 232. The connector piece 234 is positioned at or near the distal end region 222 of the shell 232 which allows the connector piece 234 toreceive bodily fluids that flow to the gravimetric low point of the porous material 210. In an embodiment, a portion of the connector piece 234 may be positioned in the sump 244 of the shell 232. In an embodiment, not shown, the connector piece 234 may form the sump 244 instead of the shell 232.

[0106] The connector piece 234 is configured to be connected to the conduit 226. As such, the connector piece 234 may define the fluid outlet 208 which configured to be attached to or otherwise in fluid communication with the conduit 226. The fluid outlet 208 may be positioned adjacent to the back side 238 of the fluid impermeable barrier 202. The connector piece 234 may also define a channel 246 (e.g., tube) configured to allow the porous material 210 and the sump 244 to be in fluid communication with the conduit 226.

[0107] In an embodiment, at least a portion of the connector piece 234 may exhibit a rigidity that is greater than the shell 232. The increased rigidity of the connector piece 234 relative to the shell 232 may facilitate attachment of the conduit 226 to the connector piece 234. In an example, the connector piece 234 may exhibit a rigidity that is greater than the shell 232 when the connector piece 234 is formed from a material exhibiting at least one of a greater Young’s modulus (z.<?., modulus of elasticity), yield strength, or ultimate tensile strength than a material that forms the shell 232. In an example, the connector piece 234 may exhibit a rigidity that is greater than the shell 232 when the connector piece 234 exhibits a thickness that is greater than the shell 232.

[0108] The fluid collection assembly shown in FIGS. 1A-2B are examples of female fluid collection assemblies that are configured to collect bodily fluids from females (e.g., collect urine from a female urethra). However, the fluid collection assemblies, systems, and methods disclosed herein may include male fluid collection assemblies shaped, sized, and otherwise configured to collect bodily fluids from males (e.g., collect urine from a male urethra). FIG. 3 is a cross-sectional schematic of male fluid collection assembly 300, according to an embodiment.

[0109] The fluid collection assembly 300 includes a base 348 (e.g., annular base) and a sheath 350. The base 348 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 348 may define an aperture 352. The base 348 is sized and shaped to be positioned around the male urethral opening (e.g., positioned around and / or over the penis) and the aperture 352 may be configured to have the male urethral opening positioned therethrough. The base 348 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 348 may exhibit the general shape or contours of the skin surface that the base 348 is selected to be coupled with. The base 348 may be flexible thereby allowing the base 348 to conform to any shape of the skin surface. The base 348 may include a laterally (e.g., radially) extending flange 354. The base 348 also defines a hollowed region that is configured to receive (e.g., seal against) the sheath 350. For example, the base 348 may include a longitudinally extending flange 356 that extends upwardly from the base 348. The longitudinally extending flange 356 may be tall enough to prevent the sheath 350 from being accidentally removed from the base 348 (e.g., at least 0.25 cm tall, 1 cm tall, at least 3 cm tall, or at least 5 cm tall). The base 348 is located at a proximal end region 324 (with respect to a wearer) of the fluid collection assembly 300.

[0110] The sheath 350 includes (e.g., may be formed from) a fluid impermeable barrier 302 that is sized and shaped to fit into the hollowed region of the base 348. For example, the sheath 350 may be generally tubular or cup-shaped, as shown. The generally tubular or cup-shaped fluid impermeable barrier 302 may at least partially define the outer surface of the sheath 350. The fluid impermeable barrier 302 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 302 may be constructed of any of the materials disclosed herein for the fluid impermeable barrier. The fluid impermeable barrier 302 at least partially defines the chamber 304. For example, the inner surface of the fluid impermeable barrier 302 at least partially defines the perimeter of the chamber 304. The chamber 304 may at least temporarily retain bodily fluids therein. The fluid impermeable barrier 302 may also define an opening 306 extending through the fluid impermeable barrier 302 that is configured to have a male urethral opening positioned therethrough.

[0111] As shown, the fluid collection assembly 300 may include the porous material 310 therein. The porous material 310 may be similar or identical any of the porous materials disclosed herein, in one or more aspects. For example, the porous material 310 may include one or more of an outer layer 312, an intermediate layer 314, an inner, support layer 316, a first bonding layer 318, and a second bonding layer 320.

[0112] The sheath 350 also includes at least a portion of the conduit 326 therein, such as at least partially disposed in the chamber 304. For example, the conduit 326 mayextend from the sheath 350 at the distal end region 322 to a proximal end region 324 at least proximate to the opening 306. The proximal end region 324 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 306 against the skin of the subject. The bodily fluids may be removed from the chamber 304 via the conduit 326.

[0113] In some examples, the fluid impermeable barrier 302 may be constructed of a material and / or have a thickness that allows the sheath 350 to collapse when placed under a vacuum, such as to remove air around a penis in the fluid collection assembly 300 during use. In such examples, the conduit 326 may extend only to or into the distal end region 322 in the chamber 304 (e.g., not through to the area adjacent the opening 306). In such examples, urine may be collected and removed from the fluid collection assembly 300.

[0114] In an example, portions of the chamber 304 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 304 (e.g., periphery of the interior regions of the sheath 350) may include the porous material 310. For example, the porous material 310 may be bonded to the inner surface of the fluid impermeable barrier 302. The porous material 310 may be positioned (e.g., at the distal end of the chamber 304) 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 304. Since the chamber 304 is substantially empty (e.g., substantially all of the chamber 304 forms a reservoir), the bodily fluids are likely to pool at a gravimetrically low point of the chamber 304. The gravimetrically low point of the chamber 304 may be at an intersection of the skin of an individual and the fluid collection assembly 300, a corner formed in the sheath 350, or another suitable location depending on the orientation of the wearer.

[0115] The porous material 310 may include one or more of the outer layer 312, the intermediate layer 314, or the inner, support layer 316. The outer layer 312, the intermediate layer 314, and the inner, support layer 316 may be similar or identical to any of the outer layers, intermediate layers, and inner, support layers, respectively disclosed herein, in one or more aspects. One or more of outer layer 312, the intermediate layer 314, or the inner, support layer 316 may be disposed between the fluid impermeable barrier 302 and a penis inserted into the chamber 304. The fluid collection assembly 300 includes a cap 357 at a distal end region 322. The cap 357 defines an interior channelthrough which the bodily fluids may be removed from the fluid collection assembly 300. The interior channel is in fluid communication with the chamber 304. The cap 357 may be disposed over at least a portion of the distal end region 322 of one or more of the fluid impermeable barrier 302 or the porous material 310. The cap 357 may be made of a polymer, rubber, or any other fluid impermeable material. The cap 357 may be attached to one or more of the fluid impermeable barrier 302, the porous material 310, or the conduit 326. The cap 357 may cover at least a portion of the distal end region 322 of the fluid collection assembly 300. The cap 357 may define a fluid outlet 308 that is sized and configured to receive and fluidly seal against the conduit 326. The conduit 326 may extend a distance within or through the cap 357, such as to the porous material 310, through the porous material 310, or to a point set-off from the porous material 310. In an example, as depicted in FIG. 3, the interior channel of the cap 357 may define a reservoir 328 therein.

[0116] The reservoir 328 is an unoccupied portion of the device such as in the cap 357 and is void of other material. In some examples, the reservoir 328 is defined at least partially by the porous material 310 and the cap 357. During use, the bodily fluids that are in the chamber 304 may flow through the porous material 310 to the reservoir 328. The reservoir 328 may store at least some of the bodily fluids therein and / or position the bodily fluids for removal by the conduit 326. In some examples, at least a portion of the porous material 310 may extend continuously between at least a portion of the opening of the interior channel and chamber 304 to wick any bodily fluids from the opening directly to the reservoir 328.

[0117] In some examples (not shown), the fluid impermeable barrier 302 may be disposed on or over the cap 357, such as enclosing the cap 357 within the chamber 304.

[0118] In some examples, the sheath 350 may include at least a portion of the conduit 326 therein, such as at least partially disposed in the chamber 304. For example, the conduit 326 may extend from the sheath 350 to a region at least proximate to the opening 306. The inlet of the conduit 326 may be positioned adjacent to the annular base 351. The inlet of the conduit 326 may be positioned to be adjacent or proximate to the gravimetrically low point of the chamber 304, such as adjacent to the annular base 351. For example, the inlet may be co-extensive with or offset from the opening 306. In examples, the inlet may be positioned adjacent to the distal end region 322 of the sheath 350 (e.g., substantially opposite the opening 306).

[0119] The proximal end region 324 may be disposed near or on the skin around the male urethral opening (e.g., around the penis) and the inlet of the conduit 326 may be positioned in the proximal end region 324. The outlet of the conduit 326 may be directly or indirectly coupled to a vacuum source. Accordingly, bodily fluids may be removed from the proximal end region 324 of the chamber 304 via the conduit 326.

[0120] The base 348, the sheath 350, the cap 357, and the conduit 326 may be attached together using any suitable method. For example, at least two of the base 348, the sheath 350, the cap 357, or the conduit 326 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.

[0121] In some examples (not shown), the fluid collection assembly 300 may have a one piece design, with one or more of the sheath 350, the base 348, and the cap 357 being a single, integrally formed piece.

[0122] Also as shown, the conduit 326 may be at least partially disposed with the chamber of a fluid collection assembly. The conduit 326 may extend from the distal end region 322 to the proximal end region 324. For example, the conduit 326 may extend through the cap 357 to a point adjacent to the base 348. The conduit 326 is sized and positioned to be coupled to a fluid storage container or the vacuum source (FIG- 6). An outlet of the conduit 326 may be operably coupled to the vacuum source, directly or indirectly. The inlet of the conduit 326 may be positioned within the chamber 304 such as at a location expected to be at the gravimetric ally low point of the fluid collection assembly 300 during use. By positioning the inlet in a location expected to be at the gravimetrically low point of the fluid collection assembly 300 when worn by the user, bodily fluids introduced into the chamber 304 may be removed via the conduit 326 to prevent pooling or stagnation of the bodily fluids within the chamber 304.

[0123] In some examples, the vacuum source may be remotely located from the fluid collection assembly 300. In such examples, the conduit 326 may be fluidly connected to the fluid storage container, which may be disposed between the vacuum source and the fluid collection assembly 300.

[0124] FIG. 4 is a cross-sectional schematic of a fluid collection assembly 400, according to an embodiment. The fluid collection assembly 400 is an example of a male fluid collection assembly though, in some embodiments, the fluid collection assembly 400 may be used to receive bodily fluids from a female urethral opening. Except as otherwise disclosed herein, the fluid collection assembly 400 is the same or substantiallysimilar to any of the fluid collection assemblies disclosed herein. The sheath 450 includes a fluid impermeable barrier 402 that is at least partially formed from a first panel 458 and a second panel 460. The first panel 458 and the second panel 460 may be attached or integrally formed together (e.g., exhibits single piece construction). In an embodiment, as illustrated, the first panel 458 and the second panel 460 are distinct sheets. The fluid impermeable barrier 402 also defines a chamber 404 between the first panel 458 and the second panel 460, an opening 406 at a proximal end region 424 of the sheath 450, and a fluid outlet 408 at a distal end region 422 of the sheath 450. The sheath 450 also includes at least one porous material 410 disposed in the chamber 404.

[0125] The inner surface(s) of the fluid impermeable barrier 402 e.g., inner surfaces of the first and second panels 454, 456) at least partially defines the chamber 404 within the fluid collection assembly 400. The fluid impermeable barrier 402 temporarily stores the bodily fluids in the chamber 404. The fluid impermeable barrier 402 may be formed from any of the fluid impermeable materials disclosed herein. As such, the fluid impermeable barrier 402 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 402.

[0126] In an embodiment, at least one of the first panel 458 or the second panel 460 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 458 or the second panel 460 from an at least partially transparent fluid impermeable material allows a person (e.g., medical practitioner) to examiner the penis. In some embodiments, both the first panel 458 and the second panel 460 are formed from at least partially transparent fluid impermeable material. Selecting at least one of the first panel 458 or the second panel 460 to be formed from an at least partially transparent impermeable material allows the penis to be examined without detaching the entire fluid collection assembly 400 from the region about the penis. For example, the chamber 404 may include a penis receiving area 462 that is configured to receive the penis of the individual when the penis extends into the chamber 404. The penis receiving area 462 may be defined by at least the porous material 410 and at least a portion of the at least partially transparent material of the first panel 458 and / or the second panel 460. In other words, the porous material 410 is positioned in the chamber 404 such that the porous material 410 is not positioned between the penis and at least a portion of the transparent portion of the first panel 458 and / or second panel 460 when the penis is inserted into the chamber 404 through the opening 406. The porous material 410 is generally nottransparent and, thus, the portion of the at least partially transparent material of the first panel 458 and / or the second panel 460 that defines the penis receiving area 462 forms a window which allows the person to view into the penis receiving area 462 and examine the penis.

[0127] The fluid collection assembly 400 includes a sheath 450 and a base 448. The base 448 is configured to be attached (e.g., permanently attached to or configured to be permanently attached) to the sheath 450. The base 448 is also configured to be attached to the region about the urethral opening (e.g., penis) of the individual.

[0128] The opening 406 defined by the fluid impermeable barrier 402 provides an ingress route for bodily fluids to enter the chamber 404 when the penis is a buried penis and allows the penis to enter the chamber 404 (e.g., the penis receiving area 462) when the penis is not buried. The opening 406 may be defined by the fluid impermeable barrier 402 (e.g., an inner edge of the fluid impermeable barrier 402). For example, the opening 406 is formed in and extends through the fluid impermeable barrier 402 thereby enabling bodily fluids to enter the chamber 404 from outside of the fluid collection assembly 400.

[0129] The fluid impermeable barrier 402 defines the fluid outlet 408 sized to receive the conduit 426. The conduit 426 may be at least partially disposed in the chamber 404 or otherwise in fluid communication with the chamber 404 through the fluid outlet 408. The fluid outlet 408 may be sized and shaped to form an at least substantially fluid tight seal against the conduit 426 thereby substantially preventing the bodily fluids from escaping the chamber 404. In an embodiment, the fluid outlet 408 may be formed from a portion of the first panel 458 and the second panel 460 that are not attached or integrally formed together. In such an embodiment, the fluid impermeable barrier 402 may not include a cap exhibiting a rigidity that is greater than the portions of the fluid impermeable barrier 402 thereabout which may facilitate manufacturing of the fluid collection assembly 400 may decreasing the number of parts that are used to form the fluid collection assembly 400 and may decrease the time required to manufacture the fluid collection assembly 400. The lack of the cap may make securing the conduit 426 to the fluid outlet 408 using interference fit to be difficult though, it is noted, attaching the conduit 426 to the fluid outlet 408 may still be possible. As such, the conduit 426 may be attached to the fluid outlet 408 (e.g., to the first and second panels 454, 456) using an adhesive, a weld, or otherwise bonding the fluid outlet 408 to the fluid outlet 408. Attaching the conduit 426 to the fluid outlet 408 may prevent leaks and may prevent the conduit 426 from inadvertently becoming detached from the fluid outlet 408. In an example, the conduit426 may be attached to the fluid outlet 408 in the same manufacturing step that attaches the first and second panels 454, 456 together. In an embodiment, the fluid collection assembly 400 includes a cap exhibiting a rigidity that is greater than portions of the fluid impermeable barrier 402 thereabout. In such an embodiment, the cap may form the fluid outlet 408. The cap may be selected to exhibit a maximum thickness that is less than equal to, or slightly greater than (e.g., at most about 3 mm greater than) the thickness of the conduit 426 such that the cap has no significant effect on the ability of the fluid impermeable barrier 402 to lie flat.

[0130] As previously discussed, the sheath 450 includes at least one porous material 410 disclosed in the chamber 404. The porous material 410 may be the same or substantially similar to any of the porous materials disclosed herein in one or more aspects. For example, the porous material 410 may include an outer layer 412, an intermediate layer 414, an inner, support layer 416, a first bonding layer 418, and a second bonding layer 420. In a particular example, the porous material 110 includes an outer layer 112 including hydrophobic polypropylene or hydrophobic polyethylene, an intermediate layer 114 including bamboo, and an inner support layer 116 including a first layer, a second layer, and a plurality of fibers extending between the first and second layers, wherein the first and second layers may include a woven material. In such an example, the porous material 410 may exhibit a relatively synergistic relationship when used with the male fluid collection assembly 400. The porous material 410 may direct the bodily fluids to one or more selected regions of the chamber 404, such as away from the penis and towards the fluid outlet 408. The porous material 410 may be formed from any of the porous materials disclosed herein. In an example, the porous material 410 may be formed from a single layer, two layers, or three or more layers. In an example, the porous material 410 may be formed from a non wo ven material or a woven material (e.g., spun nylon fibers). In an example, the porous material 410 may include at least one material exhibiting substantially no absorption or at least one absorbent or adsorbent material.

[0131] In an embodiment, the porous material 410 may be a sheet. Forming the porous material 410 as a sheet may facilitate the manufacturing of the fluid collection assembly 400. For example, forming the porous material 410 as a sheet allows the first panel 458, the second panel 460, and the porous material 410 to each be sheets. During the manufacturing of the fluid collection assembly 400, the first panel 458, the second panel 460, and the porous material 410 may be stacked and then attached to each other in the same manufacturing step. For instance, the porous material 410 may exhibit a shapethat is the same size or, more preferably, slightly smaller than the size of the first panel 458 and the second panel 460. As such, attaching the first panel 458 and the second panel 460 together along the outer edges thereof may also attach the porous material 410 to the first panel 458 and the second panel 460. The porous material 410 may be slightly smaller than the first panel 458 and the second panel 460 such that the first panel 458 and / or the second panel 460 extend around the porous material 410 such that the porous material 410 does not form a passageway through the fluid impermeable barrier 402 through which the bodily fluids may leak. Also, attaching the porous material 410 to the first panel 458 and / or the second panel 460 may prevent the porous material 410 from significantly moving in the chamber 404, such as preventing the porous material 410 from bunching together near the fluid outlet 408. In an example, the porous material 410 may be attached to the first panel 458 or the second panel 460 (e.g., via an adhesive) before or after attaching the first panel 458 to the second panel 460. In an example, the porous material 410 may merely be disposed in the chamber 404 without attaching the porous material 410 to at least one of the first panel 458 or the second panel 460. In an embodiment, the porous material 410 may exhibit shapes other than a sheet, such as a hollow generally cylindrical shape.

[0132] Generally, the sheath 450 is substantially flat when the penis is not in the penis receiving area 462 and the sheath 450 is resting on a flat surface. The sheath 450 is substantially flat because the fluid impermeable barrier 402 is formed from the first panel 458 and the second panel 460 instead of a generally tubular fluid impermeable barrier. Further, as previously discussed, the porous material 410 may be a sheet, which also causes the sheath 450 to be substantially flat. The sheath 450 may also be substantially flat because the fluid collection assembly 400 may not include relatively rigid rings or caps that exhibit a rigidity that is greater than the portions of the fluid impermeable barrier 402 thereabout since such rings and caps may inhibit the sheath 450 being substantially flat. It is noted that the sheath 450 is described as being substantially flat because at least one of the porous material 410 may cause a slight bulge to form in the sheath 450 depending on the thickness of the porous material 410, the fluid outlet 408 and / or conduit 426 may cause a bulge thereabout, or the base 448 may pull on portions of the sheath 450 thereabout. It is also noted that the sheath 450 may also be compliant and, as such, the sheath 450 may not be substantially flat during use since, during use, the sheath 450 may rest on a non-flat surface (e.g., may rest on the testicles, the perineum,and / or between the thighs) and the sheath 450 may conform to the surface of these shapes.

[0133] The ability of the sheath 450 to be substantially flat when the penis is not in the penis receiving area 462 and the sheath 450 is resting on a flat surface allows the fluid collection assembly 400 to be used with a buried and a non-buried penis. For example, when the fluid collection assembly 400 is being used with a buried penis, the penis does not extend into the penis receiving area 462 which causes the sheath 450 to lie relatively flat across the aperture 452 of the base 448. When the sheath 450 lies relatively flat across the aperture 452, the porous material 410 extends across the opening 406 and the aperture 452 and is in close proximity to the buried penis. As such, the porous material 410 prevents or inhibits pooling of bodily fluids discharged from the buried penis against the skin of the individual since the porous material 410 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 400 and preventing skin degradation. However, unlike other conventional fluid collection assemblies that are configured to be used with buried penises, the fluid collection assembly 400 may still be used with a non-buried penis since the non-buried penis can still be received into the penis receiving area 462, even when the penis is fully erect. Additionally, the ability of the sheath 450 to be substantially flat allows the fluid collection assembly 400 to be used more discretely than if the sheath 450 was not substantially flat thereby avoiding possibly embarrassing scenarios.

[0134] When the sheath 450 is substantially flat, the porous material 410 occupies substantially all of the chamber 404 and the penis receiving area 462 is collapsed (shown as being non-collapsed in FIG. 4 for illustrative purposes to show the penis receiving area 462). In other words, the sheath 450 may not define a region that is constantly unoccupied by the porous material 410. When the porous material 410 occupies substantially all of the chamber 404, the bodily fluids discharged into the chamber 404 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.

[0135] As previously discussed, the first panel 458, the second panel 460, and the porous material 410 may be selected to be relatively flexible. The first panel 458, thesecond panel 460, and the porous material 410 are relatively flexible when the first panel 458, the second panel 460, and the porous material 410, respectively, are unable to maintain their shape when unsupported. The flexibility of the first panel 458, the second panel 460, and the porous material 410 may allow the sheath 450 to be substantially flat, as discussed above. The flexibility of the first panel 458, the second panel 460, and the porous material 410 may also allow the sheath 450 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 404 in which bodily fluids may pool.

[0136] As previously discussed, the fluid collection assembly 400 includes a base 448 that is configured to be attached to the sheath 450. For example, the base 448 is configured to be permanently attached to the sheath 450. The base 448 is configured to be permanently attached to the sheath 450 when, for example, the fluid collection assembly 400 is provided with the base 448 permanently attached to the sheath 450 or the base 448 is provided without being permanently attached to the sheath 450 but is configured to be permanently attached to the sheath 450 at some point in the future. Permanently attached means that the sheath 450 cannot be detached from the base 448 without damaging at least one of the sheath 450 or the base 448, using a blade to separate the sheath 450 from the base 448, and / or using chemicals to dissolve the adhesive that attaches the sheath 450 from the base 448. The base 448 may be permanently attached to the sheath 450 using an adhesive, sewing, heat sealing, RF welding, or US welding. In an embodiment, the base 448 is configured to be reversibly attached to the sheath 450. In an embodiment, the base 448 is integrally formed with the sheath 450.

[0137] The base 448 includes an aperture 452. The base 448 is permanently attached to the distal end region 422 of the sheath 450 such that the aperture 452 is aligned with the opening 406.

[0138] The base 448 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 448 may define an aperture 452 configured to have the penis positioned therethrough. In an example, the base 448 may exhibit the general shape or contours of the skin surface that the base 448 is configured to be coupled with. The base 448 may be flexible, thereby allowing the base 448 to conform to any shape of the skin surface and mitigate the base 448 pulling the on skin surface. The base 448 may extend laterally past the sheath 450 thereby increasing the surface area of the skin of the individual to which the fluid collection assembly 400 may be attachedcompared to a substantially similar fluid collection assembly 400 that did not include a base.

[0139] As previously discussed, the fluid collection assembly 400 includes the conduit 426. The inlet of the conduit 426 may be located near the distal end region 422 of the sheath 450 which is expected to be the gravimetrically low point of the chamber 404 when worn by an individual. Locating the inlet at or near the distal end region 422 of the sheath 450 enables the conduit 426 to receive more of the bodily fluids than if the inlet of the conduit 426 was located elsewhere and reduce the likelihood of pooling (e.g., pooling of the bodily fluids may cause microbe growth and foul odors).

[0140] FIG. 5 is a block diagram of a fluid collection system 570 for fluid collection, according to an embodiment. The fluid collection system 570 includes a fluid collection assembly 500, a fluid storage container 572, and a vacuum source 574. The fluid collection assembly 500 may be the same or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 500, the fluid storage container 572, and the vacuum source 574 may be fluidly coupled to each other via one or more conduits 526. For example, fluid collection assembly 500 may be operably coupled to one or more of the fluid storage container 572 or the vacuum source 574 via the conduit 526. The bodily fluids collected in the fluid collection assembly 500 may be removed from the fluid collection assembly 500 via the conduit 526 which protrudes into the fluid collection assembly 500. For example, an inlet of the conduit 526 may extend into the fluid collection assembly 500, such as to a reservoir therein. The outlet of the conduit 526 may extend into the fluid collection assembly 500 or the vacuum source 574. Suction force may be introduced into the chamber of the fluid collection assembly 500 via the inlet of the conduit 526 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 526.

[0141] The suction force may be applied to the outlet of the conduit 526 by the vacuum source 574 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 572. For example, the outlet of the conduit 526 may be disposed within the fluid storage container 572 and an additional conduit 526 may extend from the fluid storage container 572 to the vacuum source 574. Accordingly, the vacuum source 574 may apply suction to the fluid collection assembly 500 via the fluid storage container 572. The suction force may be applied directly via the vacuum source 574. For example, the outlet of the conduit 526 may be disposed within the vacuum source 574. An additional conduit 526 may extend from the vacuum source 574 to apoint outside of the fluid collection assembly 500, such as to the fluid storage container 572. In such examples, the vacuum source 574 may be disposed between the fluid collection assembly 500 and the fluid storage container 572.

[0142] The fluid storage container 572 is sized and shaped to retain bodily fluids therein. The fluid storage container 572 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 526 may extend from the fluid collection assembly 500 and attach to the fluid storage container 572 at a first point therein. An additional conduit 526 may attach to the fluid storage container 572 at a second point thereon and may extend and attach to the vacuum source 574. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly 500 via the fluid storage container 572. Bodily fluids, such as urine, may be drained from the fluid collection assembly 500 using the vacuum source 574.

[0143] The vacuum source 574 may include one or more of a manual vacuum pump, an 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 574 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 500. In some examples, the vacuum source 574 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 574 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 500. For example, the vacuum source 574 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 574 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 574.

[0144] 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.

[0145] 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 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 defining at least a chamber, at least one opening, and a fluid outlet; and a porous material disposed in the chamber, the porous material including: an outer layer including at least one outer hydrophilic material, the at least one outer hydrophilic material including at least one of hydrophilic polypropylene or hydrophilic polyethylene; an intermediate layer including at least one intermediate hydrophilic material; an inner, support layer, a first bonding layer between the outer layer and the intermediate layer; and a second bonding layer between the intermediate layer and the inner, support layer.

2. The fluid collection assembly of claim 1, wherein the outer layer exhibits a thickness of about 2 mm or less.

3. The fluid collection assembly of any one of claims 1 or 2, wherein the outer layer exhibits a basis weight of about 10 grams per square meter (gsm) to about 32 gsm.

4. The fluid collection assembly of any one of claims 1-3, wherein the outer hydrophobic layer includes hydrophilic polypropylene.

5. The fluid collection assembly of any one of claims 1-4, wherein the outer hydrophobic layer includes hydrophilic polyethylene.

6. The fluid collection assembly of any one of claims 1-5, wherein the intermediate hydrophilic material is more hydrophilic than the outer hydrophilic material.

7. The fluid collection assembly of any one of claims 1-6, wherein the inner, hydrophilic material includes bamboo.

8. The fluid collection assembly of any one of claims 1-7, wherein the intermediate layer exhibits a thickness of about 2 mm or less.

9. The fluid collection assembly of any one of claims 1-8, wherein the intermediate layer exhibits a basis weight of 25 gsm to about 65 gsm.

10. The fluid collection assembly of any one of claims 1-9, wherein the inner, support layer includes at least one hydrophobic material.

11. The fluid collection assembly of 10, wherein the at least one hydrophobic material includes at least one of polyurethane, polyether, nylon, or hydrophobic polypropylene.

12. The fluid collection assembly of any one of claims 1-11, wherein the inner, support layer exhibits density of about 130 g / m2 / cm to about 240 g / m2 / cm.

13. The fluid collection assembly of any one of claims 1-12, wherein at least one of the first bonding layer or the second bonding layer includes a hot melt adhesive.

14. The fluid collection assembly of any one of claims 1-13, wherein at least one of the first bonding layer or the second bonding layer exhibits a basis weight of about 10 grams per square meter (gsm) to about 32 gsm.

15. The fluid collection assembly of any one of claims 1-14, wherein at least one of the first bonding layer or the second bonding layer includes an adhesive, the adhesive including at least one of polyurethane, polyether, or acrylic.

16. The fluid collection assembly of any one of claims 1-15, wherein the porous material includes a first longitudinal edge and a second longitudinal edge, the first longitudinal edge sealed to the second longitudinal edge.

17. A fluid collection system, comprising: the fluid collection assembly of any one of claims 1-16; 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.

18. A method to form a fluid collection assembly, the method comprising: forming a porous material attaching an outer layer to an intermediate layer using a first bonding layer and attaching the intermediate layer to an inner, support layer using a second bonding layer; wherein the outer layer includes at least one outer hydrophilic material, the at least one outer hydrophilic material includes at least one of hydrophilic polypropylene or hydrophilic polyethylene, the intermediate layer includes at least one intermediatehydrophilic material; disposing the porous material in a chamber defined by a fluid impermeable barrier, the fluid impermeable barrier also defining at least one opening and a fluid outlet.

19. The method of claim 18, wherein attaching an outer layer to an intermediate layer using a first bonding layer and attaching the intermediate layer to an inner, support layer using a second bonding layer includes: positioning a first adhesive between the outer layer and the intermediate layer; positioning a second adhesive between the intermediate layer and the inner, support layer; and moving the outer layer, the intermediate layer, the inner, support layer, the first adhesive and the second adhesive against at least one heated roller at a belt feeding speed of 25 cm / min to 250 cm / min, the at least one heated roller exhibiting a temperature of about 140 °C to about 180 °C.

20. The method of any one of claims 18 or 19, further comprising attaching a first longitudinal edge of the porous material to a second longitudinal edge of the porous material, wherein the porous material exhibits a sheet-like shape before attaching the first longitudinal edge of the porous material to the second longitudinal edge of the porous material.

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