Fluid collection assemblies including at least one surfactant

Abstract

An example fluid collection assembly includes a fluid impermeable barrier, The fluid impermeable barrier at least defines a chamber, at least one opening, and a fluid outlet, The fluid collection assembly also includes at least one porous material disposed in the chamber. Additionally, the fluid collection assembly includes at least one surfactant disposed on at least a portion of the porous material. The at least one surfactant may include, for example, a polyethylene glycol fatty acid ester. The surfactant of the fluid impermeable barrier may facilitate the ability of the porous material to receive bodily fluids into the porous material.

Description

FLUID COLLECTION ASSEMBLIES INCLUDING AT LEAST ONE SURFACTANTCROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 568,615 filed on March 22, 2024, the disclosure of which is incorporated herein, in its entirety, by this reference.BACKGROUND

[0002] A person or animal may have limited or impaired mobility so typical urination processes are challenging or impossible. For example, a person may experience or have a disability that impairs mobility. A person may have restricted travel conditions such as those experienced by pilots, drivers, and workers in hazardous areas. Additionally, sometimes bodily fluids collection is needed for monitoring purposes or clinical testing.

[0003] Urinary catheters, such as a Foley catheter, can address some of these circumstances, such as incontinence. Unfortunately, urinary catheters can be uncomfortable, painful, and can lead to complications, such as infections. Additionally, bed pans, which are receptacles used for the toileting of bedridden individuals are sometimes used. However, bedpans can be prone to discomfort, spills, and other hygiene issues.SUMMARY

[0004] In an embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier at least defining a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. Additionally, the fluid collection assembly includes at least one surfactant disposed on at least a portion of the at least one porous material.

[0005] In an embodiment, a fluid collection system is disclosed. The fluid collection system includes a fluid collection assembly. The fluid collection assembly includes a fluid impermeable barrier at least defining a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. Additionally, the fluid collection assembly includes at least one surfactant disposed on at least a portion of the at least one porous material. 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 morebodily fluids are present in the chamber, a suction provided from the vacuum source to the chamber of the fluid collection assembly removes the one or more bodily fluids from the chamber and deposits the bodily fluids in the fluid storage container.

[0006] In an embodiment, a method to form a fluid collection assembly is disclosed. The method includes disposing at least one surfactant on at least a portion of at least one porous material. The method also includes positioning the at least one porous material in a chamber defined by a fluid impermeable barrier. The fluid impermeable barrier at least defines the chamber, at least one opening, and a fluid outlet.

[0007] Features from any of the disclosed embodiments may be used in combination with one another, without limitation. In addition, other features and advantages of the present disclosure will become apparent to those of ordinary skill in the art through consideration of the following detailed description and the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The drawings illustrate several embodiments of the present disclosure, wherein identical reference numerals refer to identical or similar elements or features in different views or embodiments shown in the drawings.

[0009] FIG. 1 is a cross-sectional schematic of a porous body, according to an embodiment.

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

[0011] FIGS. 2B and 2C are cross-sectional views of the fluid collection assembly taken along planes 2B-2B and 2C-2C, respectively, shown in FIG. 2A.

[0012] FIG. 2D is a cross-sectional schematic of a portion of the fluid collection assembly taken from the box 2D illustrated in FIG. 2C, according to an embodiment.

[0013] FIG. 2E is a cross-sectional view of the conduit, according to an embodiment.

[0014] FIG. 3A is a cross-sectional view of a fluid collection assembly, according to an embodiment.

[0015] FIG. 3B is a cross-sectional view of the fluid collection assembly taken along plane 3B-3B shown in FIG. 3A.

[0016] FIG. A is an isometric view of a fluid collection assembly, according to an embodiment.

[0017] FIGS. 4B and 4C are cross-sectional views of the fluid collection assembly taken along planes 4B-4B and 4C-4C, respectively, shown in FIG. 4A.

[0018] FIG. 4D is a view illustration of a system 450 configured to form the porous material 410, according to an embodiment.

[0019] FIG. 5A is isometric view of a fluid collection assembly, according to an embodiment.

[0020] FIG. 5B is a cross-sectional view of the fluid collection assembly shown in FIG. 5A.

[0021] FIG. 6 is an isometric view of a fluid collection assembly, according to an embodiment.

[0022] FIGS. 7A and 7B are top isometric and bottom isometric views of a fluid collection assembly, respectively, according to an embodiment.

[0023] FIG. 8 is a cross-sectional view of a fluid collection assembly, according to an embodiment.

[0024] FIG. 9 is a front view of a male urine collection device, according to an embodiment.

[0025] FIG. 10A is an isometric view of a fluid collection assembly, according to an embodiment.

[0026] FIGS. 10B and 10C are cross-sectional views of the fluid collection assembly taken along planes 10B-10B and 10C-10C, respectively, shown in FIG. 10A.

[0027] FIG. 11 is a block diagram of a fluid collection system for fluid collection, according to an embodiment.

[0028] FIG. 12 is a graph illustrating the capture rate of the fluid collection assemblies of Working Examples 1-3.DETAILED DESCRIPTION

[0029] Embodiments disclosed herein related to methods to fluid collection assemblies including at least one surfactant, fluid collection systems including the same, and methods of making and using the same. An example fluid collection assembly includes a fluid impermeable barrier. The fluid impermeable barrier at least defines a chamber, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the chamber. Additionally, the fluid collection assembly includes at least one surfactant disposed on at least a portion of the porous material. The at least one surfactant may include, forexample, a polyethylene glycol fatty acid ester (“PEGFA”). The surfactant of the fluid impermeable barrier may facilitate the ability of the porous material to receive bodily fluids into the porous material.

[0030] During use, the fluid collection assembly may be positioned on an individual such that the opening is positioned adjacent to a urethral opening (e.g., female urethral opening or a buried penis) 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.

[0031] 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, 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 wi eking (i.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. Therelatively 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.

[0032] Some other conventional fluid collection assemblies attempt to resolve these issues associated with hydrophobic porous material by including a hydrophilic porous material. Examples of hydrophilic porous materials that are used in conventional fluid collection assemblies include some types of polyesters. 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, the hydrophilic 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.

[0033] 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.

[0034] The fluid collection assemblies disclosed herein are an improvement over such conventional fluid collection assemblies. For example, the fluid collection assemblies disclosed herein include at least one surfactant disposed on at least a portion of the porous material. As used herein, “disposed on” or similar terms (e.g., “disposing on”) is broad enough to include“disposed in” (e.g., the surfactant disposed on the porous material may also refer to the surfactant being disposed in the porous material). The surfactant modifies the water absorption and wi eking ability of the porous material. For example, the surfactant may improve the water absorption and wicking ability of the porous material. As such, the surfactant may allow the porous material to receive bodily fluids quickly and effectively. However, unlike the hydrophilic porous materials used in some conventional fluid collection assemblies, the porous material and the surfactant may not retain significant quantities of bodily fluids therein due to the hydrophobic characteristics of the porous material carrying the hydrophilic surfactant(s) thereon or therein.

[0035] The porous materials including the at least one surfactant disclosed herein may be used in any suitable fluid collection assembly. In an example, the porous materials including the at least one surfactant disclosed herein may be used in female fluid collection assemblies or male fluid collection assemblies. In an example, the porous materials including the at least one surfactant disclosed here may be configured to be used in any fluid collection assembly that includes a porous material that is configured to contact the anatomy of an individual.

[0036] FIG. 1 is a cross-sectional schematic of a porous body 101, according to an embodiment. The porous body 101 may be any of the porous materials disclosed herein or a layer of any of the porous materials disclosed herein. The porous body 101 includes an outer surface 103 and an inner surface 105 opposite the outer surface 103. The outer surface 103 may be a surface of the porous body 101 that is configured e.g., positioned) to contact the individual, such as at the urethral opening of the individual, or otherwise be more likely to receive bodily fluids discharged by an individual before the inner surface 105.

[0037] The porous body 101 is configured to be disposed in a chamber defined by a fluid impermeable barrier of a fluid collection assembly. The at least one porous body 101 may include one or more of a foam, spun fibers, a vertical nonwoven material, a woven material, a quilted material, or the like. The at least one porous body 101 may be formed from any suitable natural material (e.g., fibers, fabric, foam) or synthetic material (e.g., fibers, fabric, foam). In some embodiments, the at least one porous body 101 may include an open cell foam (e.g., polyethylene terephthalate foam), a carded web, spun fibers (e.g., spun nylon fibers), nonwoven fibers (e.g., polyethylene terephthalate nonwoven material), woven fibers, or the like. For example, the porous body 101 may include an open cell foam or a vertically nonwoven material. In an embodiment, the at least one porous body 101 may be formed from synthetic fibers orfoam. Examples of synthetic fibers or foam includes a polyester (e.g., polyethylene terephthalate), polyethylene, polypropylene, polyurethane (e.g., viscoelastic polyurethane), latex, silicone, nylon, nitrile, or the like. Some embodiments, the at least one porous body 101 may be formed from natural fibers which may be more sustainable and biodegradable than the synthetic fibers. Examples of natural fibers includes cellulose, cotton, bamboo, wool, or the like. The porous body 101 may include any of the other porous materials disclosed herein.

[0038] In some embodiments, an open-cell foam may be used for the porous body 101. The open-cell foam may have a density and porosity selected to provide a desired amount and rate of fluid transport therethrough. For example, the open-cell foam may have a density of at least 40 kg / m3, such as about 40 kg / m3to about 500 kg / m3, about 50 kg / m3to about 400 kg / m3, about 50 kg / m3to about 200 kg / m3, about 200 kg / m3to about 400 kg / m3, or less than 500 kg / m3. The open-cell foam may exhibit a porosity of at least about 15 pores per inch (PPI), such as about 20 PPI to about 120 PPI, about 20 PPI to about 50 PPI, about 50 PPI to about 100 PPI, or less than about 120 PPI. The material of the open-cell foam may be selected to have desired surface properties (e.g., hydrophilicity or hydrophobicity) and structural properties (e.g., bending stiffness or the like). As explained in more detail below, the open-cell foam may include any of a number of different materials, such as rubber, one or more polymers, or the like.

[0039] In some embodiments, the porous body 101 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 porous body 101 exhibits a basis weight of about 10 gsm to about 35 gsm. The basis weight of the porous body 101 is a function of the density and thickness of the porous body 101. It is noted that the surface area of the porous body 101 depends, in part, on the basis weight thereof. As such, increasing the basis weight of the porous body 101 (to an extent) may increase the surface area of the porous body 101. How quickly the porous body 101 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 porous body 101 may improve the rate at which the porous body 101 may receive the bodily fluids. However, increasing the basis weight of the porous body 101 may decrease the volume of the void space ofthe porous body 101 that may temporarily hold the bodily fluids therein. As such, the basis weight of the porous body 101 may be selected by balancing these factors.

[0040] In an embodiment, the porous body 101 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 about 4.25 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 about 500:1, about 450: 1 to about 550: 1, about 500: 1 toabout 600: 1, about 550: 1 to about 650:1 , about 600: 1 to about 700: 1, about 650: 1 to about 750: 1 , about 700: 1 to about 800:1, about 750: 1 to about 850:1, about 800:1 to about 900: 1, about 850: 1 to about 950: 1, or about 900: 1 to about 1,000:1.

[0041] 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 porous body 101 but may decrease the strength of the porous body 101. 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 which increases the strength and durability of the porous body 101. The entanglement of the fibers may also preclude or minimize the amount of other binding techniques that are applied to the porous body 101, such as heat, chemical binding, or other mechanical binding (e.g., further entanglement caused by needle punching or high- pressure waterjets). However, increasing the aspect ratio of the fibers may make dispersion of the fibers more difficult (e.g., uniformity of the porous body 101 difficult). Further, increasing the aspect ratio may limit the type of nonwoven webs that may form the porous body 101. 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 porous body 101 (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.

[0042] 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 urinate may vary, such as based on the size of the person and the age of the person. The porous body 101 may be selected to capture and transport the bodily fluids at a rate that is comparable to the rate at which the individual discharged bodily fluids to prevent leaks. For example, the at least one porous body 101 may be selected to capture and transport the bodily fluids at a rate that is greater than about 6 ml / s, greater than about 10 ml / s, greater than about 30 ml / s, about 6 ml / s to about 50ml / s, about 6 ml / s to about 20 ml / s, about 20 ml / s to about 40 ml / s, about 6 ml / s to about 15 ml / s, about 15 ml / s to about 25 ml / s, less than about 50 ml / s, or less than about 30 ml / s.

[0043] In some embodiments, at least one porous body 101 may be configured to wick and / or otherwise allow transport of any bodily fluids away from an opening defined by a fluid impermeable barrier or otherwise transport the bodily fluids away from the urethral opening and the individual, thereby preventing the bodily fluids from leaking or remaining in contact with the individual. The permeable properties referred to herein may be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and / or “wicking.” Such “wicking” and / or “permeable” properties may not include absorption of the bodily fluids into at least a portion of the at least one porous body 101. Put another way, substantially no absorption or solubility of the bodily fluids into the at least one porous body 101 material may take place after the at least one porous body 101 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 at least one porous body 101 (e.g., absorbency), such as less than about 30 wt% of the dry weight of the at least one porous body 101, less than about 20 wt%, less than about 10 wt%, less than about 7 wt%, less than about 5 wt%, less than about 3 wt%, less than about 2 wt%, less than about 1 wt%, or less than about 0.5 wt% of the dry weight of the at least one porous body 101. In an embodiment, the at least one porous body 101 may include at least one absorbent or adsorbent material.

[0044] In an embodiment, the at least one porous body 101 may be hydrophobic. The at least one porous body 101 may be hydrophobic when the at least one porous body 101 exhibits a contact angle with water that is about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 165°, or greater than 150°. The hydrophobic at least one porous body 101 may more quickly transport the bodily fluids received thereby than if the at least one porous body 101 is hydrophilic. Generally, increasing the hydrophobicity of the at least one porous body 101 (i.e., increasing the contact angle between the porous body 101 and water) may decrease the quantity of bodily fluids that are retained in the at least one porous body 101 after the at least one porous body 101 receives the bodily fluids. However, increasing the hydrophobicity of the at least one porous body 101 may decrease the quantity of bodily fluids that the at least one porous body 101 may receive over a certain period of time. As such, thehydrophobicity of the at least one porous body 101 may be selected based on balancing the need to receive bodily fluids quickly while also keeping the at least one porous body 101 dry.

[0045] Notwithstanding the foregoing, in an embodiment, the at least one porous body 101 may by hydrophilic. The hydrophilicity of the at least one porous body 101 may cause the at least one porous body 101 to quickly capture bodily fluids therein thereby preventing or at least inhibiting leakage of bodily fluids caused by a large discharge of bodily fluids over a short period of time. The at least one porous body 101 may be hydrophilic when the at least one porous body 101 material exhibits a contact angle with water (a major constituent of bodily fluids) that is about 0° to about 90°, about 0° to about 15°, about 15° to about 30°, about 30° to about 45°, about 45° to about 60°, about 60° to about 90°, about 10° to about 40°, about 40° to about 80°, less than about 90°, less than about 60°, or less than about 30°. Generally, increasing the hydrophilicity of the at least one porous body 101 (z.e., decreasing the contact angle between the porous body 101 and water) increases the quantity of bodily fluids that the at least one porous body 101 may receive over a certain period of time. However, increasing the hydrophilicity of the at least one porous body 101 may increase the quantity of bodily fluids that are retained in the at least one porous body 101 after the at least one porous body 101 receives the bodily fluids. As such, the hydrophilicity of the at least one porous body 101 may be selected based on balancing the need to receive bodily fluids quickly while also keeping the at least one porous body 101 dry. For example, a fluid collection assembly 100 configured to be used with an individual with a large bladder for short periods of time may include a at least one porous body 101 exhibiting a hydrophilicity that is greater than at least one porous body 101 of a fluid collection assembly 100 configured to be used with an individual with an average to small sized bladder for long period of time. It is noted that materials of at least some conventional fluid collection assemblies are selected to be hydrophobic to improve the fluid transport thereof. However, it has been unexpectedly found that vertical nonwoven materials exhibit quick fluid transport even when the vertical nonwoven materials are hydrophilic. In an embodiment, the surfactant disposed on the porous body 101 may cause the porous body 101 to be hydrophilic (e.g, the porous body 101 is hydrophobic before disposing the surfactant on the porous body 101). In an embodiment, the porous body 101 is hydrophilic before disposing the surfactant on the porous body 101. In such an embodiment, the surfactant may increase or otherwise modify the hydrophilicity of the porous body 101.

[0046] In an embodiment, the hydrophobicity or hydrophilicity of the at least one porous body 101 may be an inherent property of the material(s) (e.g., fibers) used to form the at least one porous body 101. In an embodiment, the hydrophobicity or hydrophilicity of the at least one porous body 101 may be changed by at least one of impurities or functional groups added to the at least one porous body 101, otherwise treating the at least one porous body 101, or coating the at least one porous body 101 with a material that exhibits a hydrophobicity or hydrophilicity that is different than the at least one porous body 101.

[0047] A surfactant is disposed on (e.g., coats) at least a portion of the porous body 101. In an embodiment, the surfactant may be disposed on at least the outer surface 103 of the porous body 101. Disposing the surfactant on at least the outer surface 103 of the porous body 101 may modify the outer surface 103 of the porous body 101. During use, the outer surface 103 of the porous body 101 is the surface of the porous body 101 at least one of contacts the urethral opening of the individual, is positioned closer to the urethral opening of the individual than the inner surface 105, or is otherwise positioned to be more likely to initially receive bodily fluids discharged from the individual than the inner surface 105. As such, modifying the outer surface 103 of the porous body 101 with the surfactant allows the porous body 101 to receive the bodily fluids quickly and effectively into the porous body 101.

[0048] In an embodiment, the surfactant may extend a distance from the outer surface 103 into the porous body 101. For example, the surfactant may extend from the outer surface 103 about 1% or more of a thickness t of the porous body 101, such as at least about 5% or more, about 10% or more, about 15% or more, about 20% or more, about 20% or more, about 30% or more, about 40% or more, about 50% or more, about 60% or more, about 70% or more, about 80% or more, about 90% or more, or about 100% (i.e., extends through all of the porous body 101) of the thickness t, such as in ranges of about 1% to about 10%, about 5% to about 15%, about 10% to about 20%, about 15% to about 30%, about 20% to about 40%, about 30% to about 50%, about 40% to about 60%, about 50% to about 70%, about 60% to about 80%, about 70% to about 90%, or about 80% to about 100% of the thickness t. Extending the surfactant a distance from the outer surface 103 into the porous body 101 may allow the porous body 101 to pull the bodily fluids received at the outer surface 103 into the porous body 101 which, in turn, facilitates the flow of the bodily fluids through the porous body 101. The distance that the surfactant extends from the outer surface 103 into the porous body 101 may depend on the thickness of theporous body 101. For example, the surfactant may only extend from the outer surface 103 through a relatively small percentage of the thickness t of the porous body 101 (e.g., less than 50%) when the thickness of the porous body 101 is relatively thick (e.g., about 1.5 mm or greater, about 5 mm or greater, or about 1 cm or greater). Meanwhile, the surfactant may extend from the outer surface 103 through a relatively large percentage (e.g., greater than 50%) or all of the thickness t of the porous body 101 when the thickness of the porous body 101 is relatively small (e.g, about 2 mm or less, about 1 mm or less, or about 0.75 mm or less). The distance that the surfactant extends from the outer surface 103 into the porous body 101 may also depend on the process used to apply the surfactant to the porous body 101, the viscosity of the surfactant or the solution that includes the surfactant applied to the porous body 101, the water contact angle between the surfactant or the solution that includes the surfactant and the porous body 101, the quantity of the surfactant or the solution that includes the surfactant that is applied to the porous body 101, or any other suitable factor.

[0049] In an embodiment, the surfactant is only disposed through a portion of the thickness t of the porous body 101 which allows the water absorption rates and wi eking ability of the porous body 101 to vary in the porous body 101. For example, the portions of the porous body 101 that include the surfactant may exhibit a water absorption rate and wicking ability that is better than the portions of the porous body 101 that does not include the surfactant. The better water absorption and wicking ability of the portions of the porous body 101 that include the surfactant allows the porous body 101 to receive the bodily fluids quickly and effectively into the porous body 101. The portions of the porous body 101 that do not include the surfactant may push the bodily fluids out of the porous body 101 towards the inner surface 105. The surfactant extending only partially through the porous body 101 may be beneficial when the porous body 101 forms substantially all of the porous material disposed in a chamber of a fluid collection assembly. In an embodiment, the surfactant is disposed through all or substantially all of the thickness t of the porous body 101 which allows the water absorption rates and wicking ability of all of the porous body 101 to be improved. As such, all of the porous body 101 is able to quickly receive the bodily fluids. The surfactant disposed in all or substantially all of the porous body 101 may be beneficial when the porous body 101 only forms a portion of a porous material disposed in a chamber of a fluid collection assembly since the porous material may have another porous body that is able to push the bodily fluids towards the fluid outlet.

[0050] In an embodiment, the surfactant may be disposed on the inner surface 105 and, optionally, may extend a distance from the inner surface 105 into the porous body 101. Disposing the surfactant on the inner surface 105 may facilitate disposing the surfactant on a greater percentage of the porous body 101. Disposing the surfactant on the inner surface 105 may also facilitate receiving bodily fluids into the porous body 101 that were not received into the outer surface 103 (e.g., flowed around the porous body 101 when the porous body 101 is a sheet) or receive bodily fluids back into the porous body 101 that leaked out of the porous body 101.

[0051] The surfactant may be disposed on the porous body 101 using any suitable technique. In an embodiment, the surfactant may be disposed on the porous body 101 using a spray coating technique, a kiss roll coating technique, a dip coating technique, or any other suitable technique. In an embodiment, the surfactant may only be disposed on one surface of the porous body 101. For example, the surfactant may be disposed on the outer surface 103 of the porous body 101. It is noted that the surfactant may penetrate into the porous body 101 after being disposed on the outer surface 103. In a particular embodiment, the porous body 101 forms a long sheet that, at some later point, will be cut into a plurality of porous bodies that, for example, may each be disposed in different fluid collection assemblies. In such an embodiment, the surfactant may be disposed on a surface (e.g., the outer surface 103) of the porous body 101. After disposing the surfactant on the surface, the porous body 101 may be collected on a roll. Collecting the porous body 101 on the roll may cause the surface of the porous body 101 that received the surfactant to contact the surface of the porous body 101 that did not receive the surfactant. Contacting the two surfaces together may cause the surfactant to migrate from the surface that received the surfactant to the surface that did not receive the surfactant such that both surfaces of the porous body 101 are able to receive the surfactant while the surfactant was only disposed on one surface of the porous body 101. In an embodiment, the surfactant may be disposed on both the outer surface 103 and the inner surface 105 of the porous body 101. It is noted that the surfactant may penetrate into the porous body 101 after disposing the surfactant on both the outer surface 103 and the inner surface 105 of the porous body 101.

[0052] Disposing the surfactant on the porous body 101 may include disposing a solution that includes the surfactant on the porous body 101. The solution includes at least one major component (e.g., water, alcohol, isopropanol, other polar solvents, or other non-polar solvents)and the surfactant. The surfactant may or may not be at least partially soluble in the major component. The surfactant may form about 1 wt% or more of the solution, such as in ranges of about 1 wt% to about 3 wt%, about 2 wt% to about 4 wt%, about 3 wt% to about 5 wt%, about 4 wt% to about 6 wt%, about 5 wt% to about 7 wt%, about 6 wt% to about 8 wt%, about 7 wt% to about 9 wt%, about 8 wt% to about 10 wt%, about 9 wt% to about 12 wt%, about 10 wt% to about 15 wt%, or greater than 15 wt% of the solution. In a particular example, the surfactant may form about 2 wt% to about 10 wt% of the solution since, for some surfactants (e.g., PEGFA), decreasing the concentration of the surfactant below 2 wt% may cause too little of the surfactant to be disposed on the porous body 101 and increasing the concentration of the surfactant above 10 wt% may cause too much of the surfactant to be on the porous body 101.

[0053] The surfactant may form about 0.1 wt% to about 2 wt% of the porous body 101, such as in ranges of about 0.1 wt% to about 1.4 wt% or about 0.2 wt% to about 0.8 wt%. It is noted that these weight percentages refer to the average weight percent of the surfactant in the portions of the porous body 101 that includes the surfactant. Generally, the amount of the surfactant in the porous body 101 is selected to be 0.1 wt% or greater since lesser concentrations of the surfactant may have negligible effect on the porous body 101. It is noted that the amount of the surfactant in the porous body 101 may be selected to be greater than 0.2 wt% since the surfactant may have a small but non-negligible effect on the porous body 101 when present at weight percentages between 0.1 wt% and 0.2 wt%. Generally, the amount of the surfactant in the porous body 101 may be selected to be about 2 wt% or less since increasing the quantity of the surfactant in the porous body 101 above 2 wt% may cause the porous body 101 to feel wet against the skin of the individual. It is noted that the porous body 101 may still feel wet against the skin of certain sensitive individuals when the surfactant is present at weight percentages between 1.5 wt% and 2 wt% and, for certain extra-sensitive individuals, the porous body 101 may still feel wet against the skin of certain sensitive individuals when the surfactant is present at weight percentages between 0.9 wt% and 1.4 wt%.

[0054] In a particular embodiment, the porous body 101 includes a hydrophobic material. For example, the porous body 101 may include hydrophobic polypropylene, hydrophobic polyethylene, a blend of hydrophobic polypropylene and hydrophobic polyethylene, or another hydrophobic material. The surfactant present in the porous body 101 may cause the porous body 101 including the hydrophobic material to exhibit a water absorption rate and wi eking ability thatis comparable to a substantially similar porous body including a hydrophilic material. However, the porous body 101 is still formed from a hydrophobic material and, thus, may push the bodily fluids out of the porous body 101 (e.g., due to the hydrophobic material repelling the water such that the porous body 101 does not retain the bodily fluids) instead of retaining the bodily fluids therein. As such, the hydrophobic material of the porous body 101 may be relatively dry shortly after the individual stops discharging bodily fluids.

[0055] The surfactant may include any suitable type of surfactant. For example, the surfactants may include at least one anionic surfactant, at least one nonionic surfactant, at least one cationic surfactant, at least one amphoteric surfactant, or combinations thereof. In an example, the surfactant may include at least one nonionic surfactant. In some examples, the surfactant may include polyethylene glycol oleic acid ester, polysorbate 20, polysorbate 40, polysorbate 60 and polysorbate 80, silicone polyether, fluorinated silicone polyether surfactants, dioctyl sodium sulfosuccinate, or the like.

[0056] In an embodiment, the surfactant may include PEGFA. Like the surfactants disclosed herein, PEGFA increases the water absorption rate and wicking abilities of the porous body 101 even when the porous body 101 is formed from a hydrophobic material. However, unlike at least some surfactants, PEGFA remains attached to the porous body 101 for prolonged periods of times (e.g., 1 month to over a year). For example, it has been found that non-PEGFA surfactants typically migrated from the porous body 101, such as from the porous body 101 to packaging or into another layer of the porous material that includes the porous body 101. This means that the ability of the porous body 101 including non-PEGFA surfactants disposed thereon to quick and effectively receive bodily fluids decreases over time which may result in unneeded waste if the fluid collection assembly including the non-PEGFA surfactants are not promptly used. In other words, the fluid collection assembly including the non-PEGFA surfactants may exhibit a short shelf life compared to the fluid collection assembly including the PEGFA surfactant. Unlike these other surfactants, it has been found that PEGFA surfactants remain attached to the porous body 101 and did not significantly migrate from the porous body 101 over time. As such, the porous body 101 including PEGFA may be able to receive bodily fluids even quickly and effectively if a prolonged period of time lapses between manufacturing and use of fluid collection assembly including PEGFA.

[0057] The PEGFA surfactant includes a fatty acid chain, an ester, and a polyethylene glycol chain. For example, the PEGFA may exhibit the chemical formula R COO PEG, where R is an aliphatic chain, COO is the ester group, and PEG is polyethylene glycol chain. The aliphatic chain R forms at least a portion of the hydrophobic portion of the PEGFA surfactant and attaches the PEGFA to the porous body 101. The PEG chain forms the hydrophilic head of the PEGFA surfactant. The ester group bonds the aliphatic chain R and the PEG chain together. It is noted that the ester group and the PEG chain may also help attach the PEGFA to the porous body 101. Particular example of PEGFA include STANTEX® S 6887 and STANTEX® S 6327.

[0058] Suitable PEGFA surfactants may include surfactants of formula 1 below:Formula 1 : Ri COO PEG, where: Ri = C7-C31 aliphatic chain; and PEG = a polyethylene glycol polymer chain of 200 to 4000 Daltons (“Da”).

[0059] The aliphatic chain R may include a saturated or unsaturated aliphatic carbon chain. In a particular example, the aliphatic chain R may be a saturated aliphatic carbon chain since it is currently believed that a saturated aliphatic carbon chain may better attach the PEGFA to the porous body 101 including polypropylene or polyethylene since it is more similar to polypropylene or polyethylene than an unsaturated aliphatic carbon chain. The aliphatic chain R may include 7 to 31 carbon atoms. In a particular example, the aliphatic chain R may include 8 to 24 carbon atoms since such aliphatic carbon chains are readily available.

[0060] The PEG chain of the PEGFA includes a plurality of repeating units [OCFECFEJn. In an example, n may be selected to be 5 to 600, such as in ranges of 5 to 50, 25 to 75, 50 to 100, 75 to 150, 100 to 200, 150 to 250, 200 to 300, 250 to 350, 300 to 400, 350 to 450, 400 to 500, 450 to 550, or 500 to 600. In an example, the polyethylene glycol may exhibit a molecular weight of about 200 Da to about 10,000 Da, such as in ranges of about 200 Da to about 500 Da, about 400 Da to about 1,000 Da, about 750 Da to about 1,500 Da, about 1,000 Da to about 2,000 Da, about 1,500 Da to about 2,500 Da, about 2,000 Da to about 3,000 Da, about 2,500 Da to about 3,500 Da, about 3,000 Da to about 4,000 Da, about 3,500 Da to about 5,000 Da, about 4,000 Da to about 6,000 Da, about 5,000 Da to about 7,000 Da, about 6,000 Da to about 8,000 Da, about 7,000 Da to about 9,000 Da, or about 8,000 Da to about 10,000 Da. It is noted that the number of repeated units n and the molecular weight of the polyethylene glycol may affect the ability of the PEGFA to improve the water absorption rate and wicking ability of the porous body 101.For example, increasing the number of repeating units n and the molecular weight of the polyethylene glycol may cause the PEGFA to behave more like a hydrophobic material than a surfactant.

[0061] In an embodiment, as previously discussed, the surfactant may be disposed in and / or on the porous body 101 before a fluid collection assembly including the porous body 101 is formed. In an embodiment, the surfactant may be disposed in and / or on porous body 101 after the fluid collection assembly including the porous body 101 is formed. In such an embodiment, a preformed fluid collection assembly may be retrofitted to include the surfactant. The preformed fluid collection assembly may be retrofitted by spraying or otherwise disposing at least one surfactant on the porous material of the preformed fluid collection assembly. The surfactant may be disposed on the porous material immediately (e.g., within an hour) before the preformed fluid collection assembly is used (e.g., the surfactant may include at least one PEGFA surfactant or at least one non-PEGFA surfactant) or a period of time before the preformed fluid collection assembly is used (e.g., the surfactant may include at least one PEGFA surfactant). In an example, the preformed fluid collection assembly may include the Purewick™ female external catheter available from Becton, Dickinson and Company, the PrimaFit® external urine management device available from Sage Products LLC, or the Versette® external catheter available from Medline. In such an example, disposing the surfactant on the preformed fluid collection assembly may include disposing the surfactant on a portion of the porous material extending across the opening defined by the fluid impermeable barrier (e.g., disposing the surfactant only on the portion of the portion material extending across the opening). In an example, the preformed fluid collection assembly may include the Purewick™ male external catheter available from Becton, Dickinson and Company, the PrimoFit® external urine management device available from Sage Products LLC, or the Qivi external urine management device from Consure Medical. In such an example, disposing the surfactant on the preformed fluid collection assembly may include disposing the surfactant through an opening defined by the fluid impermeable barrier, into a chamber defined by the fluid impermeable barrier, and into the porous material.

[0062] The porous body 101 may be used in any suitable fluid collection assembly. FIGS. 2A-8C are examples of fluid collection assemblies that may include the porous body 101.

[0063] FIG. 2A is an isometric view of a fluid collection assembly 200, according to an embodiment. FIGS. 2B and 2C are cross-sectional views of the fluid collection assembly 200 taken along planes 2B-2B and 2C-2C, respectively, shown in FIG. 2A. The fluid collection assembly is an example of a fluid collection assembly configured to receive bodily fluids from a urethral opening. The fluid collection assembly 200 includes a fluid impermeable barrier 202. 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 disposed in the chamber 204 that extends across the opening 206. The fluid collection assembly 200 also includes a conduit 214 having a multi -lumen configuration.

[0064] The fluid impermeable barrier 202 at least partially defines a chamber 204 (e.g., interior region) and an opening 206. The fluid impermeable barrier 202 temporarily stores the bodily fluids in the chamber 204. The fluid impermeable barrier 202 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 202 substantially prevents the bodily fluids from passing through the fluid impermeable barrier 202. In an example, the fluid impermeable barrier 202 may be air permeable and fluid impermeable. In such an example, the fluid impermeable barrier 202 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 202 may be formed from a soft and / or smooth material, thereby reducing chaffing on a wearer or user of the assembly.

[0065] The opening 206 provides an ingress route for bodily fluids to enter the chamber 204. The opening 206 may be defined by the fluid impermeable barrier 202 such as by an inner edge of the fluid impermeable barrier 202. For example, the opening 206 is formed in and extends through the fluid impermeable barrier 202 thereby enabling bodily fluids to enter the chamber 204 from outside of the fluid collection assembly 200.

[0066] In some examples, the fluid impermeable barrier 202 may define a fluid outlet 208 sized to receive the conduit 214. The at least one conduit 214 may be disposed in the chamber 204 via the fluid outlet 208. The fluid outlet 208 may be sized and shaped to form an at leastsubstantially fluid tight seal against the conduit 214 (e.g., drainage tube) thereby substantially preventing the bodily fluids from escaping the chamber 204.

[0067] As previously discussed, the fluid collection assembly 200 includes porous material 210 disposed in the chamber 204. The porous material 210 may cover at least a portion (e.g., all) of the opening 206. The at least one porous material 210 may include one or more of a foam, spun fibers, a vertical nonwoven material, a woven material, a quilted material, or the like. The porous material 210 may be the same as or substantially similar to the porous body 101 of FIG. 1. For example, the porous material 210 may include an outer surface 203. The porous material 210 may include at least one surfactant (e.g., PEGFA) extending inwardly from the outer surface 203 of the porous material 210.

[0068] FIG. 2D is a cross-sectional view of a portion of the fluid collection assembly 200 taken from the box illustrated in FIG. 2C, according to an embodiment. As shown, the at least one porous material 210 may include a vertical nonwoven material. The vertical nonwoven material is formed from a nonwoven web 218 that is folded. The folded nonwoven web 218 may include a plurality of folded portions 220 and a plurality of intermediate portions 222 extending between the folded portions 220. The folded nonwoven web 218 may include an outer surface adjacent to the fluid impermeable barrier 202 and an opposing inner surface (e.g., defining a bore that received the conduit 214). The folded portion 220 may extend generally parallel to the outer and inner surfaces of folded nonwoven web 218. The intermediate portions 222 may extend between the outer and inner surfaces of the folded nonwoven web 218. In an embodiment, the folded nonwoven web 218 may be positioned in the chamber 204 such that the folded portions 220 extend generally parallel to a longitudinal (e.g., central) axis 216 of the fluid collection assembly 200 (e.g., generally parallel to a longitudinal axis of the porous material 210) and / or extend circumferentially when the porous material 210 exhibits a generally cylindrical shape. The folded nonwoven web 218 may be positioned in the chamber 204 such that the intermediate portions 222 extend generally parallel to the longitudinal axis 216 of the fluid collection assembly 200 (e.g., generally parallel to a longitudinal axis of the porous material 210) and / or extend radially when the porous material 210 exhibits a generally cylindrical shape.

[0069] In an embodiment, the surfactant may be applied to the porous material 210 before the nonwoven web 218 is folded. In such an embodiment, the surfactant may extend from the outer surface 203 (e.g., the portions of the folded portions 220 that form the outermostcircumference of the porous material 210) and the surfaces of the intermediate portions 222 of the nonwoven material extending from the outer surface 203. In an embodiment, the surfactant may be applied to the porous material 210 after the nonwoven web 218 is folded. In such an embodiment, the surfactant may extend inwardly from the outer surface 203. In an embodiment, the surfactant may only extend inwardly from the outer surface 203 and, optional, the surfaces of the intermediate portions 222 of the nonwoven material extending from the outer surface 203. In other words, the surfactant may only be present in a portion of the porous material 210. The surfactant may only be present in a portion of the porous material 210 for a variety of reasons, such as the thickness of the porous material 210 makes it difficult to allow the surfactant to penetrate all of the porous material 210 using certain processes (e.g., spray coating processes or kiss roll coating processes), or to ensure that the porous material 210 includes a hydrophobic portion that pushes the bodily fluids towards the fluid outlet 208. In an embodiment, the surfactant is present on the inner surface 205 (e.g., the portions of the folded portions 220 that form the innermost circumference of the porous material 210) and / or is present throughout the entire porous material 210.

[0070] The vertical nonwoven material includes a plurality of fibers 224. In an embodiment, the nonwoven web 218 that forms the vertical nonwoven material may include a plurality of generally oriented fibers 224. The generally oriented fibers 224 may improve the ability of the vertical nonwoven material to capture bodily fluids and transport bodily fluids. The generally oriented fibers 224 may also improve the mechanical properties of the vertical nonwoven material. As used herein, the fibers 224 are “generally aligned” when a certain percentage of the fibers 224 are substantially parallel to each other. The certain percentage of the fibers 124 refers to at least about 70% of the fibers 124, more preferably at least about 80% of the fibers 124, more preferable 90% of the fibers 124, and even more preferably at least about 95% of the fibers 224. The fibers 224 are generally parallel to each other when the certain percentage of fibers 224 are parallel to each other ±30° more preferable ±20°, more preferably ±10°, or even more preferably ±5°.

[0071] The nonwoven web 218 may be disposed in the chamber 204 such that the fibers 224 of the folded portions 220 are generally oriented circumferentially and the fibers 224 of the intermediate portions 222 are generally oriented radially. Not wishing to be bound to theory, the circumferentially orientation of the fibers 224 of the folded portions 220 may cause the bodilyfluids received by the vertical nonwoven material to initially preferentially disperse circumferentially and the radial orientation of the fibers 224 of the intermediate portions may cause the bodily fluids to initially preferentially disperse radially into the porous material 210. Causing the bodily fluids to initially disperse circumferentially and radially quickly disperses the bodily fluids throughout a large volume of the vertical nonwoven material thereby allowing the vertical nonwoven material to quickly capture and transport the bodily fluids. It is noted that the fibers 224 do not inhibit flow of the bodily fluids in a direction that is generally parallel to the longitudinal axis 216, especially after the fibers 224 are wetted. Further, dispersing the bodily fluids throughout the vertical nonwoven material increases the surface area of any bodily fluids that may remain in the vertical nonwoven material after removing the bodily fluids from the porous material 210. The large surface area facilitates evaporation of the remaining bodily fluids with the air flow through the porous material 210. In an embodiment, the fibers 224 are randomly oriented or may be oriented differently than what is shown in FIG. 2D.

[0072] In an embodiment, as illustrated, folding the nonwoven web 218 may cause the formation of gaps 225 that extending generally parallel to the longitudinal axis 216. The gaps 225 may facilitate fluid flow in a direction that is generally parallel to the longitudinal axis 216. However, the nonwoven web 218 may be folded or compressed by the fluid impermeable barrier 202 to minimize the size of the gaps 225 to prevent pooling of the bodily fluids in the chamber 204. For example, the nonwoven web 218 may be folded or compressed by the fluid impermeable barrier 202 to cause the gaps 125 to exhibit a dimension measured perpendicular to the longitudinal axis 216 that is less than about 1 mm, less than about 0.75 mm, less than about 0.5 mm, or less than about 0.25 mm.

[0073] As previously discussed, the vertical nonwoven material may be formed from at least one nonwoven web 218 that is folded. The vertical nonwoven material may be formed from any suitable nonwoven web. In an embodiment, the nonwoven web includes at least one carded web. The carded web includes a plurality of fibers 224 that may be generally oriented in the same direction. The generally same orientation of the fibers 224 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 224 but the strength of the carded web decreases as the force applied thereto becomes more oblique or perpendicular to the orientation of the fibers 224. As such, the carded web may need to be positioned in the chamber 204 to mitigateforces being applied to the carded web that are not generally parallel to the orientation of the fibers 224 or requires addition binding between the fibers 224 (e.g., heat or chemical) to prevent unsatisfactory wear of the carded web.

[0074] In an embodiment, the nonwoven web 218 may include at least one needle punched web. The needle punched web may be formed from a sheet including a plurality of fibers 224. The sheet may include a plurality of randomly oriented fibers 224 (e.g., the fibers 224 are generally parallel to and randomly oriented in the plane), or generally oriented fibers 224 (e.g., a carded web) since the orientation of the fibers 224 may better facilitate 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 224 to become entangled and interlocked.

[0075] In an embodiment, the nonwoven web 218 may include at least one air laid web. The air laid web may exhibit a plurality of randomly oriented fibers 224. The plurality of random fibers 224 may exhibit a length that is sufficiently large that the fibers 224 become entangled and do not need be bounded together or the fibers 224 may be bonded. Due to the random orientation of the fibers 224, the air laid web tends to be isotropic and exhibit a high porosity. Similar, due to the random orientation of the fibers 224, the air laid web may exhibit a high loft. The air laid web may be formed from fibers 224 that cannot be carded (e.g., short fibers).

[0076] In an embodiment, the nonwoven web 218 may include at least one spunlaced web. The spunlaced web is formed by providing a sheet that includes randomly oriented fibers 224 or a carded web. High pressure waterjets 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 224 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.

[0077] While carded web, needle punched web, the air laid web, and the spunlaced web are the preferred nonwoven webs to be included in the vertical nonwoven material, the vertical nonwoven material may include one or more nonwoven webs other than the carded web, needle punched web, the air laid web, and the spunlaced web. For example, the vertical nonwoven material may include a wet laid web, a spunbond nonwoven web, or a meltblown nonwoven web.

[0078] The folded nonwoven web 218 may be formed from a sheet. When resting the sheet on a horizontal planar surface, the folded portions 220 may extend parallel to the horizontal planar surface and the intermediate portions 222 may extend vertically from the horizontal planar surface. The folded nonwoven web 218 may then be rolled to form the cylindrical folded nonwoven web 218.

[0079] In some embodiments, the vertical nonwoven material may include a material there does not have fibers. For example, a foam body may be utilized instead of a nonwoven web 218. The foam body may be sized, shaped, and folded similarly or identically to the folded nonwoven web 218 to form the porous body of the porous material 210. For example, the foam body may include an open cell foam body folded to have the plurality of folded portions 220 and the plurality of intermediate portions 222 extending between the folded portions 220 to form the vertical nonwoven material. In such examples, the foam body may include a foam of any of the polymers disclosed herein, such as polyurethane, polyethylene, polyethylene terephthalate, other polyesters, polyether, or the like. Bodily fluids may move through the open cell structure of the foam toward the reservoir or vacuum force (e.g., inlet of conduit 214).

[0080] Suitable vertical nonwoven materials and their properties for use in the porous material 110 are disclosed in International Patent Application No. PCT / US2022 / 042719 filed on 7 September 2022, and U.S. Provisional Patent Application No. 63 / 241,575 filed on 8 September 2021, the disclosure of each of which is incorporated herein, in its entirety, by this reference for any purpose.

[0081] The porous material 210 may exhibit a thickness t that is greater than about 1 mm, such as in ranges of 1 mm to about 30 mm, about 1 mm to about 10 mm, about 10 mm to about 20 mm, about 20 mm to about 30 mm, about 5 mm to about 15 mm, about 15 mm to about 25 mm, less than about 30 mm, or less than about 20 mm. Increasing the thickness t of the porous material 210 generally increases the volume of bodily fluids that may be temporarily stored in the porous material 210, and allows greater flexibility in selecting the density and basis weight of the porous material 210. However, the thickness t of the porous material 210 may be limited by the size and functionality of the fluid collection assembly 200. For example, the thickness t of the porous material 210 may be selected such that the porous material 210 may be disposed in the chamber 204, along with any other components that may also be disposed in the chamber 204, such as porous membrane material 336 (FIG. 3B), or a conduit 214.

[0082] The rate at which the porous material 210 captures and transports the bodily fluids may depend on a number of factors. For example, the rate at which a vertical nonwoven material captures and transports the bodily fluids may depend inversely on the density and weight basis of the vertical nonwoven material, wherein increasing the density and / or weight basis of the vertical nonwoven material may decrease the rate at which the vertical nonwoven material captures and transports the bodily fluids and vice versa. In an example, the rate at which the porous material 210 captures and transports the bodily fluids may depend on the material (e.g, hydrophilicity of the material) that forms the porous material 210. The rate at which the porous material 210 captures and transports the bodily fluids may increase with increasing thickness t since increasing the thickness t increases the cross-sectional area through which the bodily fluids may flow.

[0083] Referring back to FIGS. 2A-2C, in an embodiment, as illustrated, the porous material 210 may only or substantially only include a single porous layer. In such an embodiment, the single porous layer may define a bore that is configured to receive the conduit 214 and the single porous layer extends from the bore to the fluid impermeable barrier 202. When the porous material 210 includes only or substantially only the single porous layer, all of the porous material 210 is able to quickly capture and transport the bodily fluids. As explained in more detail below, the porous material 210 may include at least one additional material, such as porous membrane material, even though such additional material may decrease at least one of the ability of the porous material 210 to capture and / or transport the bodily fluids.

[0084] The fluid collection assembly 200 may include a sump or reservoir therein to collect bodily fluids. The sump may be an occupied or unoccupied portion of the chamber 204. The sump may be a portion within the chamber 204 at or near where the inlet of the conduit 214 is located. The porous material 210 may at least substantially completely fill the portions of the chamber 204 that are not occupied by the conduit 214. In some examples, the porous material 210 may not substantially completely fill the portions of the chamber 204 that are not occupied by the conduit 214. In such an example, the fluid collection assembly 200 includes a reservoir 226 (e.g., sump) disposed in the chamber 204.

[0085] As depicted, the reservoir 226 (sump) may be a substantially unoccupied portion of the chamber 204. The reservoir 226 may be defined between the fluid impermeable barrier 202 and porous material 210. The bodily fluids that are in the chamber 204 may flow through theporous material 210 to the reservoir 226. The reservoir 226 may retain of the bodily fluids therein. The fluid impermeable barrier 202 may retain the bodily fluids in the reservoir 226. While depicted in the distal end region 232, the reservoir 226 may be located in any portion of the chamber 204 such as the proximal end region 234. The reservoir 226 may be located in a portion of the chamber 204 that is designed to be located in a gravimetrically low point of the fluid collection assembly when the fluid collection assembly 200 is worn.

[0086] While depicted as portions of the chamber 204 not occupied by the porous material 210, the reservoir 226 or sump may be occupied by the porous material 210 and still function as a reservoir or sump. For example, the porous material 210 may fdl substantially of the chamber 204 not occupied by the conduit 214 and the reservoir 226 may be a distal end region of the chamber or any other region of the chamber 204 configured to retain the bodily fluid therein while or prior to being removed via the conduit 214.

[0087] In some examples (not shown), the fluid collection assembly 200 may include multiple reservoirs, such as a first reservoir that is located at the portion of the chamber 204 closest to the inlet of the conduit 214 (e.g., distal end region 232) and a second reservoir that is located at the portion of the of the chamber 204 that is at or near proximal end region 234). In another example, the porous material 210 is spaced from at least a portion of the conduit 214, and the reservoir 226 may be the space between the porous material 210 and the conduit 214.

[0088] FIG. 2E is a cross-sectional view of the conduit 214, according to an embodiment. Referring to FIGS. 2B, 2C and 2E, the conduit 214 includes a fluid lumen 247 and a shape memory lumen 249 therein. The conduit 214 includes an outer wall 246 and an inner wall 248 at least partially defining the fluid lumen 247 and shape memory lumen 249, respectively. The outer wall 246 and the inner wall 248 of the conduit 214 may be constructed of a polymer, such as silicone, polyvinyl chloride (PVC), polyethylene, thermoplastic polyurethane, a thermoplastic elastomer (e.g., a synthetic rubber), or the like. The conduit 214 may have a Shore A hardness of at least 40, such as about 40 to about 95, about 50 to about 95, about 40 to about 60, about 60 to about 80, about 75 to about 95, less than 95, or less than 75. The conduit 114 may have a length of at least a meter, such as about 1 m to about 5 m, about 1 m to about 3 m, about 2 m to about 4 m, or less than 5 m.

[0089] The conduit 214 may be at least partially disposed in the chamber 204. The conduit 214 may be used to remove the bodily fluids from the chamber 204. The conduit 214 includes atleast one wall (e g., outer wall 246) defining an inlet 212, an outlet (not shown) downstream from the inlet 212, and a passageway therebetween.

[0090] The outlet of the conduit 214 may be operably coupled to a vacuum source, such as a vacuum pump for withdrawing fluid from the chamber 204 through the conduit 214. For example, the conduit 214 may extend into the fluid impermeable barrier 202 from the proximal end region 234 and may extend to the distal end region 232 to a point proximate to the reservoir 226 therein such that the inlet 212 is in fluid communication with the reservoir 226. The conduit 214 fluidly couples the chamber 204 with the fluid storage container (not shown) or the vacuum source (not shown). In some embodiments, the inlet 212 may be disposed at or near the fluid impermeable barrier 202 in the distal end region 232.

[0091] The conduit 214 may extend through a bore in the porous material 210. In an embodiment, the conduit 214 extends from the fluid outlet 208, through the bore, to a location that is proximate to the reservoir 226. In such an embodiment, the inlet 212 may not extend into the reservoir 226 and, instead, the inlet 212 may be disposed within the porous material 210 or at a terminal end thereof. For example, an end of the conduit 214 may be coextensive with or recessed within the porous material 210. In an embodiment, the conduit 214 is at least partially disposed in the reservoir 226 and the inlet 212 may be extended into or be positioned in the reservoir 226. In an embodiment, the inlet 212 may be positioned aft of the reservoir 226. The bodily fluids collected in the fluid collection assembly 200 may be removed from the chamber 204 via the conduit 214.

[0092] Locating the inlet 212 at or near a location expected to be the gravimetrically low point of the chamber 204 when worn by an individual enables the conduit 214 to receive more of the bodily fluids than if inlet 212 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 210 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 210 is saturated with the bodily fluids. Accordingly, one or more of the inlet 212 or the reservoir 226 may be located in the fluid collection assembly 200 in a position expected to be the gravimetrically low point in the fluid collection assembly 200 when worn by an individual, such as the distal end region 232.

[0093] The inlet 212 and the outlet of the conduit 214 are configured to fluidly couple (e.g., directly or indirectly) the vacuum source (not shown) to the chamber 204 (e.g., the reservoir 226). As the vacuum source (FIG. 11) applies a vacuum / suction in the conduit 214, the bodily fluids in the chamber 204 (e.g., at the distal end region 232 such as in the reservoir 226) may be drawn into the inlet 212 and out of the fluid collection assembly 200 via the conduit 214. In some examples, the conduit 214 may be frosted or opaque (e.g., black) to obscure visibility of the bodily fluids therein.

[0094] As previously discussed, the conduit 214 may be configured to be at least insertable into the chamber 204. In an example, the conduit 214 may be positioned in the chamber 204 such that a terminal end of the conduit 214 is spaced from the fluid impermeable barrier 202 or other components of the fluid collection assembly 200 that may at least partially obstruct or block the inlet 212. Further, the inlet 212 of the conduit 214 may be offset relative to a terminal end of the porous material 210 such that the inlet 212 is closer to the proximal end region 234 of the fluid collection assembly 200 than the terminal end of the porous material 210. Offsetting the inlet 212 in such a manner relative to the terminal end of the porous material 210 allows the inlet 212 to receive bodily fluids directly from the porous material 210 and, due to hydrogen bonding, pulls more bodily fluids from the porous material 210 into the conduit 214.

[0095] The multiple lumen configuration may include the fluid lumen 247 for transporting fluids and at least one shape memory lumen 249 for containing a shape memory material 250 therein.

[0096] The fluid lumen 247 is sized and shaped to allow bodily fluids to flow therethrough. As shown in FIG. 2E, the fluid lumen 247 may be a larger than the shape memory lumen 249. For example, the fluid lumen 247 may have an inside diameter (or major dimension) of at least about 0.1 inches (2.5 mm), such as about 0.1 inches to about 0.5 inches (12.7 mm), about 0.15 inches (3.8 mm) to about 0.35 inches (8.9 mm), about 0.25 inches (6.3 mm) to about 0.4 inches (10.2 mm), or less than about 0.5 inches.

[0097] The shape memory lumen 249 is sized and shaped to accommodate a shape memory material 250 therein. For example, the shape memory lumen 249 may have an inside diameter (or major dimension) of at least about 0.03 inches (0.76 mm), such as about 0.03 inches to about 0.1 inches (2.5 mm), about 0.03 inches to about 0.05 inches (1.3 mm), about 0.05 inches to about 0.07 inches (1.8 mm), or less than about 0.1 inches. While the shape memory lumen 249 isdepicted as being positioned in the gravimetrically low point of the conduit 214 (e.g., in the bottom of the fluid lumen 247), the shape memory lumen may be disposed at any point in the fluid lumen 247, such as at the lateral sides (e.g., 3 o’clock or 9 o’clock) or the top (e.g., 12 o’clock position).

[0098] Referring back to FIGS. 2B and 2C, the shape memory lumen 249 may contain the shape memory material 250 in a discrete portion of the longitudinal length of the conduit 214, such as a portion of the shape memory lumen 249 that is within the longitudinal length of the fluid impermeable barrier 202. The shape memory material 250 may include an element configured to allow the shape of the fluid collection assemblies to be controllably changed and / or maintain a selected shape.

[0099] The at least one shape memory material 250 may prevent or at least inhibit bodily fluids leaking from the fluid collection assembly 200. For example, bodily fluids may leak from the fluid collection assembly because, initially, the fluid collection assembly 200 may exhibit a poor fit with the anatomy of a wearer (e.g., user) about the urethral opening. The poor fit may cause gaps to be present between the porous material 210 and the region about the urethral opening. These gaps may provide locations through which the bodily fluids may flow without being received by the porous material 210 and / or locations at which bodily fluids may leave the porous material 210. To minimize or eliminate the gaps, the fluid collection assembly 200 includes the shape memory material 250 disposed in the shape memory lumen 249. The shape memory material 250 is configured to be manipulated (e.g., bent or otherwise shaped) which, in turn, causes the fluid collection assembly 200 to exhibit a shape that matches the anatomical shape of the patient and to conform to the shape of the anatomy of the wearer about the urethral opening (e.g., vaginal region). In other words, the shape memory material 250 enables a more anatomically precise fit for the fluid collection assembly 200 with the region about the urethral opening than conventional fluid collection assemblies.

[0100] The shape memory material 250 is sized, shaped, and positioned in the fluid collection assembly 200 to cause at least a portion of the fluid collection assembly 200 to retain a selected shape (e.g., geometric configuration). The shape memory material 250 is configured to be bent, shaped, or otherwise deformed (hereafter collectively referred to as “shape,” “shaped,” or “shaping”). The shape memory material 250 may be configured to be shaped along an entire length thereof. Allowing the shape memory material 250 to be shaped along the entire lengththereof may allow the fluid collection assembly 200 to exhibit a shape that substantially corresponds to the anatomical features of the patient. For example, the shape memory material 250 may exhibit a first (e.g., initial) shape and the fluid collection assembly 200 may exhibit the first configuration (i.e., a generally linear shape) when the shape memory material 250 exhibits the first shape. The shape memory material 250 may be manipulated to exhibit a second shape that is different than the first shape and the fluid collection assembly 200 may exhibit the second configuration (e.g., a generally curved cylindrical shape) when the shape memory material 250 exhibits the second shape. The second configuration of the fluid collection assembly 200 may better correspond to the shape of the region about the urethral opening than the first configuration.

[0101] The shape memory material 250 may include a shape memory polymer or a metal (e.g., shape memory metal). Generally, the shape memory material 250 is composed to adopt an intermediate or permanent shape in response to a stimuli. For example, the shape memory material 250 may exhibit a first (e.g., initial) shape and may be switched from the first shape to a second shape by an external stimuli to adopt a second shape that is different from the first shape. The shape memory material 250 may also be switched from the second shape back to the first shape or a third shape that is different than the first and second shapes in response to the stimuli.

[0102] The stimuli may include an external physical force (e.g., bending force), heat, electrical bias, or a magnetic field. While the term “shape memory” is used to describe some of the “shape memory materials” herein, it should be understood that, in some examples, the material modified by the term “shape memory” may not necessarily need to return to a preselected shape upon application of a stimuli, as understood as the classical definition of the “shape memory material.” Rather, at least some of the shape memory materials disclosed herein may simply hold a selected shape when bent, set, or cured into a specific shape and / or when cooled in a specific shape, regardless of the stimuli applied thereto after. The shape memory materials may be returned to the original shape or changed to a new shape by application of the stimuli. For example, a metal wire bent to a first shape may be utilized as the shape memory material 250, whereinafter the metal wire may be modified to a second shape via physical force applied thereto or via heating. However, in some embodiments, the shape memory material 250 may exhibit a selected shape, as discussed above and application of the stimuli may cause the shape memory material to deform (e.g., elastically deform or bend) into an intermediateshape. In such embodiments, the shape memory material 250 may return to the first initial shape upon removal of the stimuli such that the shape memory material 250 does not maintain the intermediate shape.

[0103] The shape memory material 250 is distinct (e.g., may move independently) from the conduit 214. The shape memory material 250 may include a rod, a wire, a cable, or other structure disposed in the shape memory lumen 249. The shape memory material 250 may have a cylindrical shape, an extruded ovoid shape, or a polygonal extruded shape. The shape memory material 250 may be sized to fit within the shape memory lumen 249. For example, the shape memory material 250 may have a diameter (or major dimension) that is at least about 0.03 inches, such as about 0.03 inches to about 0.1 inches, about 0.03 inches to about 0.05 inches, about 0.05 inches to about 0.07 inches, less than about 0.15 inches, or less than about 0.1 inches. In some embodiments, the shape memory material 250 may include a 12 gauge (2.05 mm) to 20 gauge (0.81 mm) wire, such as a 14 gauge (1.63 mm) wire. The shape memory material 250 may be smaller than the shape memory lumen 249, such as at least 0.001 inches (25.4 pm) smaller, 0.001 inches to 0.1 inches, 0.001 inches to 0.01 inches (254 pm), 0.01 inches to 0.04 inches, 0.04 inches to 0.1 inches smaller than the shape memory lumen 249. Such examples provide a selected fit between the shape memory material 250 and the shape memory lumen 249, such as a slip fit, a sliding fit, a running fit, a loose fit, or the like that allow the shape memory material 150 to move (e.g., longitudinally) with respect to the shape memory lumen 249.

[0104] In some examples, the shape memory material 250 may be slightly larger than the shape memory lumen 249, such as 0.001 inches larger to 0.01 inches larger. Such examples may provide a tight fit between the shape memory material 250 and the shape memory lumen 249 such that the shape memory material 250 does not move with respect to the shape memory lumen 249.

[0105] In an embodiment, the shape memory material 250 may include metal, such as an elemental metal, an alloy, or shape memory alloy. Suitable shape memory metals may include aluminum, silver, copper, iron, nickel, zinc, tin, beryllium, or the like. Suitable shape memory alloys may include standard steels, stainless steel, carbon alloy steel, head treated steel, galvanized steel, aluminum alloys, nickel -titanium alloys (e.g., Nitinol, Ni — Ti — Cu, Ni — Ti, Co, or the like), copper, copper-based alloys (e.g., brass, Cu — Zn — Al, Cu — Al — Ni, Cu — Al — Sn, or the like), Co — Cr — Ni — Mo alloys (e.g., Elgiloy® or the like), or any other alloy havingshape memory characteristics. As explained above, the shape memory metals or alloys may merely be metals or alloys that may be shaped to a selected configuration. In some examples, the shape memory metals or alloys may return to a primary shape when an external stimuli is applied thereto. In some examples, the outer surface of the shape memory metal may be coated with a polymer, anodized, passivated, or otherwise treated to prevent corrosion. In some examples, the shape memory metal may be annealed, tempered, or otherwise heat treated. Such heat treating may reduce brittle breakage and increase ductility of the shape memory material 250.

[0106] Shape memory polymers (“SMPs”) may include polyurethane-based SMPs such as a copolymer (e.g., copolyester, polyurethane, polyetherester, etc.) including blocks of one or more of poly(s-caprolactone), polyethyleneterephthalate (PET), polyethyleneoxide (PEO), polyethylene glycol (PEG), polystyrene, polymethylmethacrylate (612MA), Polybutylmethacrylate (PBMA), poly(N,N-butadiene), poly(N-methyl-N-oxazoline), polytetrahydrofuran, or poly(butylene terephthalate); thermoplastic polymers such as polyether ether ketone (PEEK), nylon, acetal, polytetrafluoroethylene (PTFE), polypropylene, polyethylene, acrylonitrile butadiene styrene (ABS), polysulphone, or the like; Polynorbonene; other deformable polymers; or any other shape memory polymer.

[0107] The shape memory material 250 may be retained within the shape memory lumen 249 by one or more plugs disposed at or near the (opposite) longitudinal ends thereof. The plugs may include a stop plug 254 and an end plug 252. The plugs may be sized, shaped, and located to fit within the shape memory lumen 249 and to prevent the shape memory material 250 from moving (longitudinally) within the shape memory lumen 249 beyond the plugs. For example, the stop plug 254 and end plug 252 may be disposed at opposite ends of the shape memory material 250 in the shape memory lumen 249 to prevent longitudinal movement of the shape memory material 250 within the shape memory lumen 249.

[0108] The stop plug 254 and end plug 252 may be constructed of a resilient material, such as a polymer, an epoxy, rubber, a metal, wood, or the like. Suitable polymers may include a PVC, a polycarbonate, a polyethylene, a polypropylene, a polyacetal, polytetrafluoroethylene, an acrylic, or any of the polymers disclosed herein. For example, the stop plug 254 and end plug 252 may be constructed of a heat seal PVC. The stop plug 254 and end plug 252 may be constructed of any of the metal materials disclosed herein. In such examples, the stop plug 254 and end plug 252 may be annealed, tempered, or otherwise heat treated. The stop plug 254 andend plug 252 may be constructed of an adhesive, such as adhesive dams formed in the shape memory lumen 249. The adhesive may be a UV cured adhesive, a catalyst cured adhesive, a heat cured adhesive, or the like. The stop plug 254 and end plug 252 may have a major dimension that is sized to provide a press fit, an interference fit, a fixed fit, a similar fit, a force fit, or any other tight fit within the shape memory lumen 249. For example, the stop plug 254 and end plug 252 may have a largest outer dimension that is about 0.001 inches to 0.03 inches, about 0.001 inches to about 0.01 inches, about 0.01 inches to about 0.02 inches, or less than about 0.03 inches smaller than the inner dimension of the shape memory lumen 249. The stop plug 254 and end plug 252 may match the shape of the shape memory lumen 249, such as cylindrical, an extruded ovoid, an extruded polygonal shape, or the like. In some examples, one or more portions of the stop plug 254 and end plug 252 may have a tapered shape, such as cylindrical, rounded, or the like. The stop plug 254 and end plug 252 may have a length or lengths that is at least about 0.05 inches (0.13 cm), such as about 0.05 inches to about 0.2 inches (0.51 cm), about 0.1 inches (0.25 cm) to about 0.25 inches (0.64 cm), or less than about 0.25 inches.

[0109] The end plug 252 may (longitudinally) positioned within the shape memory lumen 249 at a point therein selected to be a distal-most point that the shape memory material 250 may extend. For example, the end plug 252 may be positioned within the shape memory lumen 249 at or adjacent to the inlet 212. The end plug 252 may be spaced from the inlet 212 by at least about 0.01 inches, about 0.01 inches to about 0.25 inches, or less than about 0.5 inches. The end plug 252 is sized, shaped, and positioned to retain the shape memory material 250 within the shape memory lumen 249 by preventing the shape memory material 250 from falling out of the distal end of the shape memory lumen 249. Accordingly, the end plug 252 is retained in place within the shape memory lumen 249 such as by fit with the shape memory lumen 249, an adhesive, or welding.

[0110] The stop plug 254 may be (longitudinally) positioned within the shape memory lumen 249 at a point therein selected to be a proximal-most point that the shape memory material 250 may extend. For example, the stop plug 254 may be disposed at a point in the shape memory lumen 249 that is within the chamber 204, within the fluid outlet 208, or even outside of the fluid outlet 208 (e.g., more proximal to the wearer or user than the fluid impermeable barrier).

[0111] In some embodiments, the stop plug 254 may be disposed at a point in the shape memory lumen 249 that is outside of the fluid outlet 208 (e g., more proximal to the wearer oruser than the fluid impermeable barrier 202). The stop plug 254 is sized, shaped, and positioned to retain the shape memory material 250 within the distal end region of the shape memory lumen 249 by preventing the shape memory material 250 from sliding into a more proximal region of the shape memory lumen 249 than the region within or near the fluid impermeable barrier 202. Accordingly, the stop plug 254 is retained in place within the shape memory lumen 249 such as by fit with the shape memory lumen 249, an adhesive, or welding.

[0112] The space in the shape memory lumen 249 between the end plug 252 and the stop plug 254 may be longer than the shape memory material 250 to allow a selected amount of movement of the shape memory material 250 therein. For example, the space in the shape memory lumen 249 between the end plug 252 and the stop plug 254 may be at least about 0.1 inches longer than the shape memory material 250, such as about 0.1 inches to about 1 inch (2.5 cm), about 0.1 inches to about 0.3 inches (0.76 cm), 0.15 (0.38 cm) inches to 0.35 inches (0.89 cm), 0.3 inches to 0.6 inches (1.52 cm), about 0.5 inches (1.27 cm) to 1 inch, less than 1 inch, or less than 0.5 inches. Such a space allows a selected amount of longitudinal movement of the shape memory material 250 within the shape memory lumen 249. The ability of the shape memory material 250 to move within the shape memory lumen 249, provided by the space and a shape memory material 250 that is slidable within the shape memory lumen 249, allows for better bending (radial bending, kinking, or the like) of the shape memory material 250, conduit 214, and fluid collection assembly 200, than a shape memory material 250 that is fixed with respect to the shape memory lumen 249. Such improved bending is due to a reduction in tensile forces introduced during bending of the shape memory material 250 when the shape memory material 250 is not adhered to the inside surface of the shape memory lumen 249.

[0113] As noted above, the end plug 252 and stop plug 254 may be retained within the shape memory lumen 249 by an adhesive, fit (between the plugs and the lumen), or welding (e.g., melting). The stop plug 254 may have an adhesive applied thereto prior to positioning with the shape memory lumen 249. After the stop plug 254 is positioned and the adhesive cures or dries, the shape memory material 250 may be disposed in the shape memory lumen 249 so that the shape memory material can slide or move longitudinally therein. The end plug 252 may have an adhesive applied thereto prior to positioning with the shape memory lumen 249, such that a selected amount of space is provided between the plugs and the shape memory material 250.

[0114] The porous materials of fluid collection assemblies disclosed herein may include both a porous (fluid permeable) body and a porous membrane. FIG. 3A is a cross-sectional view of a fluid collection assembly 300, according to an embodiment. FIG. 3B is a cross-sectional view of the fluid collection assembly 300 taken along plane 3B-3B shown in FIG. 3A. The fluid collection assembly 300 includes a porous material 310 having a porous body material 338 and a porous membrane material 336 disposed thereover. Except as otherwise disclosed herein, the fluid collection assembly 300 may be similar or identical to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 300 may include a fluid impermeable barrier 302 at least defining a chamber 304, at least one opening 306, and a fluid outlet 308. The fluid collection assembly 300 includes the conduit 314, having the shape memory material 350, end plug 352, and stop plug 354 therein. Also, the at least one porous body material 338 of the porous material 310 may be the same or substantially similar to any of the porous materials disclosed herein, such as any of the porous body materials 338 disclosed herein (e.g., polyurethane foam, spun nylon fibers, or vertical nonwoven material). In an embodiment, the porous body material 338 may support the porous membrane material 336 disposed thereover, while in other embodiments the porous membrane material 336 may be supported by the fluid impermeable barrier 302 or another component.

[0115] The porous membrane material 336 may include any suitable porous material, such as a porous sheet. In an example, the porous membrane material 336 may include gauze (e.g., a silk, linen, or cotton gauze), another soft fabric, another smooth fabric, a horizontal lapped nonwoven material, a cross lapped nonwoven material, a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam (e.g, spun nylon fiber), or any other suitable porous material. The porous material 336 may be formed from natural fibers which may be more sustainable and biodegradable than the synthetic fibers. Examples of natural fibers includes cellulose, cotton, bamboo, wool, or the like. In some examples, the fibers of the porous membrane material 336 (e.g., gauze) may include a blend of natural fibers and synthetic fibers. For example, the porous membrane material 336 may include bamboo fibers and polypropylene fibers. In an example, the porous membrane material 336 may include a hydrophobic material (e.g., a material exhibiting a contact angle with water that is greater than 90°).

[0116] In an example, the porous membrane material 336 (e.g., a gauze, a vertical nonwoven material, or a quilted material) may exhibit a density, basis weight, thickness, different average fiber length, different average fiber lateral dimension, different average fiber aspect ratio, or different rate at which the porous membrane material 336 captures and transports the bodily fluids than the porous body material 338.

[0117] In some examples, the porous membrane material 336 may include a three- dimensional mesh material (3D mesh material). The 3D mesh material may include a top layer, a fiber layer, and a bottom layer. The top layer includes a mesh textile. The mesh textile may include polyester, polypropylene, nylon, cellulose, cotton, bamboo, any other materials, or combinations of any of the foregoing. The top layer may be hydrophilic. The hydrophilicity may be from the material itself or a coating applied thereto. By utilizing a hydrophilic material in the top layer, moisture is preferentially moved away from the skin of the wearer of the fluid collection assembly 300. The top layer may include pores formed in the mesh. Larger pores may provide faster incorporation of urine into the porous material below (e.g., fiber layer or porous body material 338). The fiber layer includes a plurality of fibers, such as spun plastic fibers or the like. The fiber layer may include polyester, nylon, or cellulose fibers. The fiber layer may be bound to the top layer by one or more of an adhesive, welding (e.g., melting together), or the like. The fiber layer is constructed to separate the top layer from the bottom layer and move urine from the top layer to the bottom layer without retaining the urine. The bottom layer includes a mesh textile. The mesh textile may include polyester, polypropylene, nylon, cellulose, cotton, bamboo, any other materials, or combinations of any of the foregoing. The bottom may be hydrophobic. The hydrophobicity may be from the material itself or a coating applied thereto. The bottom layer includes pores formed in the mesh. The pores in the top layer may be larger than the pores in the bottom layer. The bottom layer may be joined to the fiber layer in the same manner as the top layer.

[0118] In an embodiment, as illustrated, the porous membrane material 336 is disposed on an outer surface of the at least one porous body material 338 (e.g., between the fluid impermeable barrier 302 and the porous body material 338) such that the porous membrane material 336 extends across the opening 306 and contacts the individual during use. The porous membrane material 336 may be disposed on the porous body material 338 to make the fluid collection assembly 300 more comfortable to use and / or improve capture of the bodily fluids. In anexample, an individual may find direct contact between the porous body material 338 and the sensitive vaginal region of the individual uncomfortable, for instance, due to the surface roughness of a foam or fibers protruding of the porous body material 338. In such an example, the porous membrane material 336 may include a material (e.g., gauze) that is smoother or otherwise more comfortable than the porous body material 338. In an example, as previously discussed, the hydrophilicity of the porous body material 338 may be limited to facilitate removing bodily fluids therefrom. However, limiting the hydrophilicity of the porous body material 338 may limit the ability of the porous body material 338 to capture bodily fluids. As such, the porous membrane material 336 may be selected to exhibit a hydrophilicity that is greater than (i.e., a contact angle with water that is less than) the porous body material 338 which allows the porous membrane material 336 to capture bodily fluids more quickly than the porous body material 338. When the porous membrane material 336 exhibits a hydrophilicity that is greater than the porous body material 338, the porous membrane material 336 may exhibit a thickness that is significantly less than the thickness of the porous body material 338. The smaller thickness of the porous membrane material 336 decreases the volume of bodily fluids that are retained in the porous membrane material 336 that have to be evaporated by air flow through the chamber 304.

[0119] In an embodiment, the porous membrane material 336 may be the same as or substantially similar to the porous body 101 of FIG. 1 since the porous membrane material 336 is the portion of the porous material 310 that is configured to initially receive bodily fluids discharged from the individual. For example, the porous membrane material 336 may include an outer surface 303 and a surfactant (e.g., any of the surfactants disclosed herein) may extend from the outer surface 303 through at least a portion of the porous membrane material 336.

[0120] In an embodiment, the porous membrane material 336 may be positioned between the porous body material 338 and the conduit 314 instead of or in addition to being disposed on the outer surface of the porous body material 338.

[0121] The porous materials of fluid collection assemblies disclosed herein may include three or more layers. For example, FIG. 4A is an isometric view of a fluid collection assembly 400, according to an embodiment. FIGS. 4B and 4C are cross-sectional views of the fluid collection assembly 400 taken along planes 4B-4B and 4C-4C, respectively, shown in FIG. 4A. Except as otherwise disclosed herein, the fluid collection assembly 400 is the same as orsubstantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 400 includes a fluid impermeable barrier 402. The fluid impermeable barrier 402 at least defines a chamber 404, at least one opening 406, and a fluid outlet 408. The fluid collection assembly 400 also includes at least one porous material 410 disposed in the chamber 404 that extends across the opening 406. The porous material 410 includes an outer layer 412, an intermediate layer 414, and an inner, support layer 416. The outer layer 412 includes at least one outer hydrophilic material. The intermediate layer 414 includes at least one intermediate hydrophilic material.

[0122] The fluid collection assembly 400 includes at least one porous material 410 disposed in the chamber 404. The porous material 410 may cover at least a portion (e.g., all) of the opening 406. The porous material 410 is exposed to the environment outside of the chamber 404 through the opening 406. The porous material 410 may include an outer layer 412, an intermediate layer 414, and at least one inner, support layer 416 that are each distinct from each other (e.g., formed from different materials, exhibit different contact angles with water, etc.).

[0123] The outer layer 412 of the porous material 410 is positioned within the chamber 404 to extend across the opening 406. The outer layer 412 is positioned in the porous material 410 to be closer to the urethral opening of the individual than the intermediate layer 414. In other words, the outer layer 412 may include the portions of the porous material 410 that initially receive the bodily fluids from the individual. As such, in an embodiment, the outer layer 412 may include at least one hydrophilic material. For example, the outer layer 412 is configured to quickly receive the bodily fluids discharged from the individual since the outer layer 412 may initially receive (or at least receive before the intermediate layer 414) the bodily fluids to prevent the bodily fluids leaking from the porous material 410. As previously discussed, the outer layer 412 is able to quickly receive the bodily fluids and, thus, forming the outer layer 412 from at least one hydrophilic material allows the outer layer 412 to quickly receive the bodily fluids.

[0124] The outer layer 412 may is hydrophilic. The hydrophilicity of the outer layer 412 may cause the outer layer 412 to quickly receive bodily fluids therein, thereby preventing or at least inhibiting leakage of bodily fluids caused by a large discharge of bodily fluids over a short period of time. As will be discussed in more detail below, the outer layer 412 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 414. Since the outer layer 412 ishydrophilic, the outer layer 412 is able to quickly receive bodily fluids. However, the decreased hydrophilicity of the outer layer 412 relative to the inner hydrophilic material allows the portions of the porous material 410 that contact the patient to be drier than if the outer layer 412 or the intermediate layer 414 was omitted from the porous material 410.

[0125] In an embodiment, the outer layer 412 may include at least one of polypropylene or polyethylene, such as a blend of polypropylene and polyethylene. It is noted that, generally, polypropylene and polyethylene are hydrophobic. As such, the outer layer 412 may include at least one surfactant (e.g., any of the surfactants disclosed herein) disposed in at least a portion thereof which effectively causes the outer layer 412 to behave similar to a hydrophilic material. In other words, the outer layer 412 may be the same as or substantially similar to the porous body 101 of FIG. 1.

[0126] That said, the outer layer 412 may include one or more hydrophilic materials other than or in addition to polypropylene and polyethylene. For example, the outer layer 412 may include at least one of natural or treated acrylics, polyvinylchloride, polyester, polyurethane, cellulose-based fibers, or any other suitable hydrophilic material.

[0127] The outer layer 412 of the porous material 410 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.

[0128] As previously discussed, the outer layer 412 may be hydrophilic due to the presence of the surfactant therein which may cause the outer layer 412 to retain the bodily fluids therein. It is noted that the hydrophobicity of the polypropylene or the polyethylene may reduce the quantity of bodily fluids that are retained in the outer layer 412. However, to further decrease the quantity of bodily fluids retained by the outer layer 412, the outer layer 412 may be configured to be relatively thin. For example, the outer layer 412 may be configured to exhibit a thickness measured perpendicularly to the longitudinal axis 430 (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 orless, about 300 pm or less, about 250 irn or less, about 200 pirn or less, about 150 pim or less, about 130 pirn or less, about 100 pirn or less, about 75 pun or less, about 60 pun or less, about 50 pun or less, about 40 pun or less, about 30 pun or less, about 25 pun or less, about 20 pun or less, or in ranges of about 20 pun to about 30 pun, about 25 pim to about 40 pun, about 30 pun to about 50 pun, about 40 pim to about 60 pim, about 50 pim to about 75 pim, about 60 pim to about 100 pim, about 75 pim to about 130 pim, about 100 pim to about 150 pim, about 130 pim to about 200 pim, about 150 pim to about 300 pim, about 200 pim to about 400 pim, about 300 pim to about 500 pim, about 400 pim to about 600 pim, about 500 pim to about 700 pim, about 600 pim to about 800 pim, about 700 pim to about 1 mm, about 800 pim 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 412 decreases the overall volume of the outer layer 412 thereby decreasing the volume of bodily fluids that may be retained in the outer layer 412. The decreasing volume of bodily fluids held within the outer layer 412 allows the air flow through the chamber 404 to quickly evaporate the bodily fluids that are retained in the outer layer 412 (i.e., the bodily fluids that failed to transfer from the outer layer 412 to the intermediate layer 414) thereby maintaining the porous material 410 dry. Further, decreasing the thickness of the outer layer 412 may allow the intermediate layer 414 to pull more bodily fluids from the outer layer 412.

[0129] In an embodiment, the outer layer 412 may be formed from at least one nonwoven web. The outer layer 412 may be formed from any suitable nonwoven web. In an embodiment, the nonwoven web of the outer layer 412 includes one or more of at least one carded web, at least one needle punched web, at least one air laid web, at least one spunbonded web, at least one spunlaced web, at least one vertical lapped nonwoven fabric, at least one horizontal lapped nonwoven fabric, at least one crossed lapped nonwoven fabric, or any of the other nonwoven webs disclosed herein. In an embodiment, the outer layer 412 may include a woven fabric instead of or in addition to a nonwoven web. Forming the outer layer 412 from a woven material may increase the durability of the porous material 410 than if the outer layer 412 is formed from a nonwoven material. However, forming the outer layer 412 from a woven material may decrease the compressibility of the porous material 410 thereby making the porous material 410 less comfortable and may make conforming the porous material 410 to the vaginal region, which limits leaks, more difficult. Also, it is more difficult to form a woven outer layer 412 than a nonwoven outer layer 412. As such, using the woven outer layer 412 may cause logistic issues,increase manufacturing difficulties, and increase cost. Further, it may be difficult to obtain a woven outer layer 412 exhibiting a sufficiently low basis weight to be effective wherein a nonwoven outer layer 412 exhibiting a sufficiently low basis weight may be easy to obtain.

[0130] The outer layer 412 is disposed on an outer surface of the intermediate layer 414. The bodily fluids received (e.g., directly) by the outer layer 412 flow from the outer layer 412 to the intermediate layer 414. The bodily fluids may flow from the outer layer 412 to the intermediate layer 414 for a variety of reasons. For example, the relatively small thickness of the outer layer 412 only allows the outer layer 412 to hold a relatively small volume of bodily fluids. As such, the outer layer 412 may become quickly saturated with the bodily fluids thereby forcing the bodily fluids to flow from the outer layer 412 to the intermediate layer 414. Further, as will be discussed in more detail below, a suction may be applied to the chamber 404. The suction may cause the bodily fluids to flow from the outer layer 412 into the intermediate layer 414. Additionally, the intermediate layer 414 includes an intermediate hydrophilic material. The hydrophilicity of the intermediate hydrophilic material pulls the bodily fluids from the outer layer 412 into the intermediate layer 414. It is noted that the flow of the bodily fluids from the outer layer 412 to the intermediate layer 414 prevents or at least inhibits the bodily fluids that are received into the outer layer 412 from leaking from the outer layer 412. The flow of the bodily fluids from the outer layer 412 to the intermediate layer 414 decreases the volume of bodily fluids that are retained in the outer layer 412 after the patient urinates (z.c., makes the outer layer 412 feel drier).

[0131] The intermediate layer 414 may be hydrophilic. For example, the intermediate layer 414 may include an intermediate hydrophilic material that is hydrophilic. In an embodiment, the overall hydrophilicity of the intermediate layer 414 is greater than the overall hydrophilicity of the outer layer 412. For example, the intermediate layer 414 may exhibit a contact angle with water than is less than the outer layer 412, 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 414 relative to the outer layer412 causes the intermediate hydrophilic material to pull bodily fluids from the outer layer 412. For example, the increased hydrophilicity of the intermediate layer 414 relative to the outer layer 412 causes the intermediate layer 414 to exhibit a greater affinity for the bodily fluids thereby causing the bodily fluids in the outer layer 412 to preferentially flow to the intermediate layer 414. Due to hydrogen bonding, the bodily fluids that flow into the intermediate layer 414 also pull additional bodily fluids into the intermediate layer 414. The ability of the intermediate layer 414 to pull bodily fluids from the outer layer 412 into the intermediate layer 414 decreases the volume of bodily fluids in the outer layer 412 (z.e., dries the outer layer 412). For example, the intermediate layer 414 may pull sufficient quantities of bodily fluids from the outer layer 412 that the quantities of bodily fluids in the outer layer 412 is negligible and may be relatively quickly evaporated due to air flow through the outer layer 412 caused by the suction provided to the chamber 404. Further, the increased hydrophilicity of the intermediate layer 414 prevent or at least minimizes backflow of the bodily fluids from the intermediate layer 414 to the outer layer 412.

[0132] In an embodiment, the intermediate layer 414 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 polypropylene and polyethylene. It has also been found that bamboo has a greater synergistic effect with polypropylene and polyethylene than expected. For example, an intermediate layer 414 including bamboo is able to pull a greater percentage of bodily fluids from a polypropylene and / or polyethylene and minimize back flow of bodily fluids from the intermediate layer 414 to the outer layer 412 better than expected.

[0133] The bamboo of the intermediate layer 414 may be formed from any bamboo material. In an example, the intermediate layer 414 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 414 may include black bamboo (z.e., 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.

[0134] The bamboo of the intermediate layer 414 may include bamboo kun. Bamboo kun is a material naturally found in bamboo. The bamboo kun causes the intermediate layer 414 toexhibit antifungal properties and antibacterial properties against both Gram-positive and Gramnegative bacteria. As such, the presence of the bamboo kun in the intermediate layer 414 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 414 is not vulnerable to attack by infectious microbials that may cause CAUTI. The bamboo kun also causes the intermediate layer 414 to be odor resistant, unlike porous materials used in conventional fluid collection assemblies. The odor resistant abilities of the intermediate layer 414 makes using the fluid collection assemblies including the intermediate layer 414 less embarrassing to use since, unlike conventional fluid collection assemblies, the fluid collection assemblies including the intermediate layer 414 are unlikely to have a noticeable odor of urine or blood. Unlike the porous materials of conventional fluid collection assemblies, the bamboo kun also causes the intermediate layer 414 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 414 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 414 may be grown without pesticides, fungicides, and insecticides. This results in the intermediate layer 414 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 414 to remove such materials. Also, the bamboo kun causes the intermediate layer 414 to be more hypoallergenic than other porous materials used in conventional fluid collection assemblies.

[0135] The intermediate layer 414 may include one or more hydrophilic intermediate materials instead of or in addition to bamboo. In an example, the intermediate layer 414 includes at least one of cotton, rayon, or viscose. In an embodiment, the intermediate layer 414 may be formed from any cellulose-based material. In an example, the intermediate layer 414 is formed from naturally derived cellulose which may be more ecologically friendly than other cellulose materials. In an example, the intermediate layer 414 may include any of the nonwoven or woven fabrics disclosed herein. In an example, the intermediate layer 414 may include any of the porous materials disclosed herein, such as a porous material including at least one surfactant disposed therein. It has been surprisingly found that cotton, rayon, viscose, and other cellulose-base materials have a more synergistic relationship with the outer layer 412 (e.g., polypropylene and polyethylene) than other hydrophilic materials. The synergistic relationship includes quickly and effectively moving the bodily fluids from the outer layer 412 to the intermediate layer 414. That said, it is currently believed that bamboo is better able to receive bodily fluids from the outer layer 412 and minimize back flow of the bodily fluids than cotton, rayon, viscose, and other cellulose-base materials.

[0136] In an embodiment, the hydrophilicity of the intermediate layer 414 may be an inherent property of the bamboo and some of the other materials disclosed herein that are used to form the intermediate layer 414. In an embodiment, the hydrophilicity of the intermediate layer 414 may be changed (e.g., increased or decreased) by at least one of impurities or functional groups added to the intermediate layer 414, otherwise treating the intermediate layer 414, or coating the intermediate layer 414 with a material that exhibits a hydrophilicity that is different than the intermediate layer 414. It is noted that the hydrophilicity of the intermediate layer 414 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%.

[0137] The intermediate layer 414 of the porous material 410 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.

[0138] As previously discussed, the intermediate layer 414 may be formed from a hydrophilic material which may cause the intermediate layer 414 to retain the bodily fluids therein. To decrease the quantity of bodily fluids retained by the intermediate layer 414, the intermediate layer 414 may be configured to be relatively thin. For example, the intermediate layer 414 may be configured to exhibit a thickness measured perpendicularly to the longitudinalaxis 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 m 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 414 decreases the overall volume of the intermediate layer 414 thereby decreasing the volume of bodily fluids that may be retained in the intermediate layer 414. The decreasing volume of bodily fluids held within the intermediate layer 414 allows air flow through the chamber 404 to quickly evaporate the bodily fluids that are retained in the intermediate layer 414 (z.e., the bodily fluids that failed to transfer from the intermediate layer 414 to the intermediate layer 414) thereby maintaining the porous material 410 dry. Further, decreasing the thickness of the intermediate layer 414 may allow the intermediate layer 414 to pull more bodily fluids from the intermediate layer 414.

[0139] The intermediate layer 414 of the porous material 410 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 414 exhibits a basis weight of about 25 gsm to about 65 gsm. The basis weight of the intermediate layer 414 is a function of the density and thickness of the intermediate layer 414. As such, the basis weight of the intermediate layer 414 may be selected for any of the same reasons as the density and thickness of the intermediate layer 414. It is noted that thesurface area of the intermediate layer 414 depends, in part, on the basis weight thereof As such, increasing the basis weight of the intermediate layer 414 (to an extent) may increase the surface area of the intermediate layer 414. How quickly the intermediate layer 414 is able to pull bodily fluids into itself from the outer layer 412 depends, in part, on the surface area thereof. However, increasing the basis weight of the intermediate layer 414 may decrease the volume of the void space of the intermediate layer 414 that may temporarily hold the bodily fluids therein. As such, the basis weight of the intermediate layer 414 may be selected by balancing these factors.

[0140] The intermediate layer 414 may be disposed on an outer surface of the inner, support layer 416. The inner, support layer 416 is configured to support the outer layer 412 and the intermediate layer 414 since the outer layer 412 and the intermediate layer 414 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material. For example, the inner, support layer 416 may be positioned such that the outer layer 412 and the intermediate layer 414 are disposed between the inner, support layer 416 and the fluid impermeable barrier 402. As such, the inner, support layer 416 may support and maintain the position of the outer layer 412 and the intermediate layer 414. The inner, support layer 416 may include any hydrophobic material. In an example, the inner, support layer 416 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). The inner, support layer 416 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. In an example, the inner, support layer 416 is substantially similar to the porous material 210. In an example, the inner, support layer 416 may include any of the porous material disclosed herein.

[0141] In an embodiment, the inner, support layer 416 may be configured to move any bodily fluids away from the intermediate layer 414, thereby preventing the bodily fluids from escaping the chamber 404. Put another way, substantially no absorption or solubility of the bodily fluids into the material may take place after the inner, support layer 416 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 414. The inner, support layer 416 may also wick the bodily fluids generally towards an interior of the chamber 404, as discussed in more detail below.

[0142] In an embodiment, at least a portion of the inner, support layer 416 may be hydrophobic or at least more hydrophobic than the intermediate layer 414. The inner, support layer 416 may be hydrophobic when the inner, support layer 416 exhibits a contact angle with water (a major constituent of bodily fluids) that is greater than about 90°, such as in ranges of about 90° to about 120°, about 105° to about 135°, about 120° to about 150°, about 135° to about 175°, or about 150° to about 180°. The hydrophobicity of the inner, support layer 416 may limit absorption, adsorption, and solubility of the bodily fluids in the inner, support layer 416 thereby decreasing the amount of bodily fluids held in the inner, support layer 416. The lower hydrophilicity of the outer layer 412 and the intermediate layer 414 may help the porous material 410 receive the bodily fluids from the urethral opening while the hydrophobicity of the inner, support layer 416 limits the bodily fluids that are retained in the porous material 410.

[0143] The hydrophobicity of the inner, support layer 416 facilitates flow of the bodily fluids from the outer layer 412 and the intermediate layer 414 towards the fluid outlet 408 (e.g., towards an inlet of the conduit 426 positioned through the fluid outlet 408). For example, some of the bodily fluids that are received by the intermediate layer 414 flow into the inner, support layer 416. The bodily fluids may flow from the intermediate layer 414 to the inner, support layer 416 because, for example, the bodily fluids are already flowing from the outer layer 412 into the intermediate layer 414 and the suction provided to the chamber 404 causes the bodily fluids to preferentially flow from the intermediate layer 414 towards the inner, support layer 416. The hydrophobicity of the inner, support layer 416 discourages the bodily fluids from remaining in the inner, support layer 416 which, in turn, pushes the bodily fluids towards the fluid outlet 408. However, the bodily fluids received into the inner, support layer 416 are still hydrogen bonded to the bodily fluids in the intermediate layer 414. As such, the inner, support layer 416 pulls bodily fluids from the intermediate layer 414 into the inner, support layer 416 as the inner, support layer 416 pushes the bodily fluids towards the fluid outlet 408. The ability of the inner, support layer 416 to pull bodily fluids into itself decreases the quantity of bodily fluids that are retained in theintermediate layer 414 (even when the intermediate layer 414 includes bamboo) can cause the intermediate layer 414 to pull bodily fluids more effectively into itself from the outer layer 412. Thus, the inner, support layer 416 effectively decreases the quantity of bodily fluids that are retained in the porous material 410 after urination.

[0144] It is noted that the intermediate layer’s 414 ability to pull bodily fluids from the outer layer 412 and move the bodily fluids into the inner, support layer 416 are different. For example, the intermediate layer 414 uses a hydrophilic-hydrophilic interaction between the outer layer 412 (e.g., the outer layer 412 may be hydrophilic due to the presence of the surfactant therein) and the intermediate layer 414 to move bodily fluids from the outer layer 412 to the intermediate layer 414 and a hydrophilic-hydrophobic interaction between the intermediate layer 414 and the inner, support layer 416 to move the bodily fluids from the intermediate layer 414 to the inner, support layer 416. It is surprising that the intermediate layer 414 is able to effectively cause bodily fluids to flow effectively through the porous material 410 even though the intermediate layer 414 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 416 (i.e., are able to more effectively move bodily fluids from the intermediate layer 414 to the inner, support layer 416) than other hydrophilic materials.

[0145] The inner, support layer 416 may exhibit a thickness (e. ., 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 416 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 400 leaks. However, increasing the thickness of the inner, support layer 416 may dilute any suction force applied to the chamber 404 and may make it difficult to position the fluid collection assembly 400 between the legs of the patient.

[0146] In an embodiment, the thickness of the inner, support layer 416 may be greater than the thickness of the outer layer 412. Generally, decreasing the thickness of the outer layer 412 decreases the volume of bodily fluids that may be stored in the outer layer 412 and decreases the volume of bodily fluids that the inner, support layer 416 may pull from the outer layer 412. Also, increasing the thickness of the inner, support layer 416 may increase the ability of inner, support layer 416 to promote flow of the bodily fluids towards to the fluid outlet 408 (e.g., towards an inlet of the conduit 426).

[0147] In an embodiment, the inner, support layer 416 includes at least one inner porous material. In an example, the inner porous material 416 includes at least one of a vertical 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 404 of the fluid collection assembly 400 and towards an outlet e.g. , the fluid outlet 408 or an inlet of a conduit 426 disposed through the fluid outlet 408) which allows the porous material 410 to remain dry. Further, it has been surprisingly found that the bodily fluids received into the outer layer 412 may flow easily from the outer layer 412 into the inner porous material and the inner porous material pulls bodily fluids from the outer layer 412 that would otherwise remain in the polyurethane foam.

[0148] 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 ofthe 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 410 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.

[0149] 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 410 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.

[0150] The inner, support layer 416 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 weight of the inner, support layer 416 is a function of the density and thickness of the inner, support layer 416. As such, the basis weight of the inner, support layer 416 may be selected for any of the same reasons as the density and thickness of the inner, support layer 416. Generally, the basis weight of the inner, support layer 416 is selected to be less than the basis weight of the outer layer 412. The lower basis weight of the inner, support layer 416 increases the void space in the inner, support layer 416 whichfacilitate flowing the bodily fluids therethrough (e.g., towards the fluid outlet 408) whereas the greater basis weight of the outer layer 412 may increase the surface area thereof.

[0151] In a particular example, the porous material 410 includes an outer layer 412 including polypropylene or polyethylene with at least one surfactant, an intermediate layer 414 including bamboo, and an inner support layer 416 including polyurethane, poly ether, nylon, polyethylene terephthalate, or hydrophobic polypropylene. In a particular example, the porous material 410 includes an outer layer 412 including polypropylene or polyethylene, an intermediate layer 414 including bamboo, and an inner support layer 416 including a nonwoven material (e.g, a vertical lapped nonwoven material and / or a polyethylene terephthalate nonwoven material). In a particular example, the porous material 410 includes an outer layer 412 including polypropylene or polyethylene, an intermediate layer 414 including bamboo, and an inner support layer 416 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 410 may exhibit a relatively good synergistic relationship compared to other porous materials.

[0152] 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, it has been found that each of the layers of the porous materials 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. To remedy these issues, the porous material 410 may include a first bonding layer 418 (shown schematically in FIGS. 4B and 4C as a bolded line) between the outer layer 412 and the intermediate layer 414 thereby maintaining the outer layer 412 and the intermediate layer 414together. Further, the porous material 410 may include a second bonding layer 420 (shown schematically in FIGS. 4B and 4C as a bolded line) between the intermediate layer 414 and the inner, support layer 416 thereby maintain the intermediate layer 414 and the inner, support layer 416 together. The first bonding layer 418 bonds the outer layer 412 and the intermediate layer 414 together such that substantially no air gaps form therebetween. The second bonding layer 420 bonds the intermediate layer 414 and the inner, support layer 416 together such that substantially no air gaps form therebetween. For example, the first and second bonding layers 418, 420 may prevent or at least inhibit air gaps from forming between the layers of the porous material 410 even during prolonged use of the fluid collection assembly 400, when the fluid collection assembly 400 is bent, or even when the outer layer 412 accidently rips.

[0153] The first and second bonding layers 418, 420 may include any suitable material that bonds the layers of the porous material 410 together. In an example, the first bonding layer 420 and / or the second bonding layer 420 includes a hot melt adhesive or any other suitable adhesive. In an example, the outer layer 412 and the intermediate layer 414 and / or the intermediate layer 414 and the inner, support layer 416 are ultrasonically welded together. In such an example, the first bonding layer 418 and / or the second bonding layer 420 includes the portions of the layers of the porous material 410 that are welded together.

[0154] The first bonding layer 418 is only positioned between a portion of the outer layer 412 and the intermediate layer 414 and the second bonding layer 420 is only positioned between a portion of the intermediate layer 414 and the inner, support layer 416. For example, the first and second bonding layers 418, 420 may be positioned between about 40% to about 80% of the surface area of the adjacent layers of the porous material 410, such as about 40% 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 418, 420 between a portion of the adjacent layers allows holes to be present in the first and second bonding layers 418, 420. The bodily fluids may flow between the layers of the porous material 410 through the holes in the first and second bonding layers 418, 420. It is noted that the first bonding layer 418 and / or the second bonding layer 420 may form a plurality of patches. At least some of the patches formed by the bonding layers 418, 420 may be interconnected or not interconnected (z.e., spaced from each other).

[0155] It is noted that any of the porous materials disclosed herein that include a plurality of porous layers may include a bonding layer, as discussed above.

[0156] In an embodiment, one or more layers of the porous material 410 may be omitted. For example, one or more of the outer layer 412, the intermediate layer 414, or the inner, support layer 416 may be omitted. The thicknesses of the layers of the porous material 410 may be adjusted when one or more layers are omitted. For example, the thickness of the intermediate layer 414 may be increased to extend from the conduit 426 to the outer layer 412 when the inner, support layer 416 is omitted. In an embodiment, the porous material 410 may include one or more additional layers (not shown), such as a thin layer on the outer layer 412 that is more comfortable than the outer layer 412.

[0157] FIG. 4D is a view illustration of a system 450 configured to form the porous material 410, according to an embodiment. It is noted that the system 450 may be configured to form any of the porous materials disclosed herein, for example, by adding or removing rollers. The system 450 includes a first roll 452, a second roll 454, and a third roll 456. The first roll 452 includes and is a source of the hydrophilic outer material of the outer layer 412. The second roll 454 includes and is a source of the hydrophilic intermediate material of the intermediate layer 414. The third roll 456 includes and is a source of the inner porous material of the inner, support layer 416. The system 450 may further include at least one of a fourth roll 458 and a fifth roll 460. The fourth and fifth rolls 458, 460 may include an adhesive material (c.g., hot melt adhesive, polyurethane, polyether, or acrylic) when the first and second bonding layers 418, 420 are formed from a porous adhesive material.

[0158] The system 450 is configured to position the outer layer 412 adjacent to the intermediate layer 414 and the intermediate layer 414 adjacent to the inner, support layer 416. In other words, the system 450 is configured to position the intermediate layer 414 between the outer layer 412 and the inner, support layer 416. The second roll 454 may be positioned between the first roll 452 and the third roll 456. Such position of the second roll 454 allows the hydrophilic intermediate material to be positioned between the hydrophilic outer material and the inner porous material when the porous material 410 is formed.

[0159] When the system 450 includes the fourth and / or fifth rolls 458, 460, the system 450 may also be configured to position the first bonding layer 418 between the outer layer 412 and the intermediate layer 414 and the second bonding layer 420 between the intermediate layer 414and the inner, support layer 416. For example, the fourth roll 458 may be positioned between the first and second rolls 452, 454 and / or the fifth roll 460 may be positioned between the second roll 454 and the third roll 456.

[0160] The system 450 may pull the materials from the rolls to form the porous material 410 using any suitable technique. In an example, as illustrated, the system 450 may include one or more rollers 462. The roller 462 may rotate and, responsive to the rotation thereof, pull the materials from the rolls to form the porous material 410. The rollers 462 may allow each of the layers to be simultaneously or substantially simultaneously positioned adjacent to each other. The system 450 including the rollers 462 may pull the layers into the rollers 462 and form the porous material 410 at a rate of about 45 cm / minute to 300 cm / minute, such as in ranges of about 45 cm / minutes to about 50 cm / minutes, about 25 cm / minute to about 75 cm / minute, about 50 cm / minute to about 400 cm / minute, about 75 cm / minute to about 425 cm / minute, about 400 cm / minute to about 450 cm / minutes, about 425 cm / minute to about 200 cm / minute, about 450 cm / minute to about 250 cm / minute, or about 200 cm / minute to about 300 cm / minute. In an example, the system 450 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 416 may be positioned on the conveyor belt, the first bonding layer 418 may be positioned on the inner, support layer 416, the intermediate layer 414 may be positioned on the first bonding layer 418, and so forth) to form the porous material 410.

[0161] The layers of the porous material 410 may be attached to each other using any suitable technique. In an embodiment, as shown, the rollers 462 may be configured to attach the layers of the porous material 410 together. In an example, the first and second bonding layers 418, 420 may include a heat-activated adhesive (e.g., a hot melt adhesive). In such an example, one or more of the rollers 462 may be heated such that passing the layers of the porous material 410 adjacent to the heated roller 462 activates the heat-activated adhesive. The temperature of the heated rollers 462 may depend on the composition of the heat-activated adhesive. In a particular example, the heated rollers 462 may exhibit a temperature of about 440 °C to about 480 °C since such temperature are able to activate some hot melt adhesives without damaging the polypropylene and / or polyethylene outer layer 412 or the bamboo intermediate layer 414. In an example, the first and second bonding layers 418, 420 may include a pressure-activated adhesive and passing the layers of the porous material 410 adjacent to the roller 462 provides thepressure that activates the adhesive. Tn an embodiment, the first and second bonding layers 418, 420 are formed using an ultrasonic weld, a radio frequency weld, or any other suitable weld.

[0162] In an embodiment, the system 450 forms a porous material 410 that is a long, continuous sheet. In such an embodiment, the system 450 may include cutting the long, continuous porous material 410 to form a plurality of porous materials 410 that are sized to fit in the chamber 404. For example, the system 450 may cut the continuous porous materials 410 into a plurality of porous materials 410 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).

[0163] The surfactant may be disposed on the outer layer 412 using any suitable technique. In an embodiment, the surfactant may be disposed on the outer layer 412 when the outer layer 412 is collected on the roller 452. In an embodiment, the surfactant may be sprayed on the outer layer 412 after the outer layer 412 is pulled off the roller 452, such as when the outer layer 412 is between the roller 452 and the heated rollers 462 or after the porous material 410 is formed using the heated rollers 462. In an embodiment, the surfactant may be disposed on the outer layer 412 using a kiss roll coating processes. In such an embodiment, the top heated roller 462 or another roller may be configured to dispose the surfactant in or on the outer layer 412.

[0164] In some embodiments, the fluid collection assemblies disclosed herein may include four or more porous materials.

[0165] FIG. 5A is an isometric of a fluid collection assembly 500, according to an embodiment. FIG. 5B is a cross-sectional view of the fluid collection assembly 500. Except as otherwise disclosed herein, the fluid collection assembly 500 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 500 includes a fluid impermeable barrier 502. The fluid impermeable barrier 502 at least defines a chamber 504, at least one opening 506, and a fluid outlet 508. The fluid collection assembly 500 also includes at least one porous material 510 disposed in the chamber 504 that extends across the opening 506.

[0166] The porous material 510 includes a porous membrane material 536 and a porous body material 538. Except as otherwise disclosed herein, the porous membrane material 536 may be the same as or substantially similar to the porous membrane material 336 and the porous bodymaterial 538 may be the same or substantially similar to the porous body material 538. For example, the porous membrane material 536 may be disposed on the porous body material 538, extend across the opening 506, and include at least one surfactant e.g., any of the surfactants disclosed herein) disposed in at least a portion thereof. However, unlike the porous membrane material 536, the porous membrane material 536 does not extend around the circumference of the porous body material 538 but only extends around a portion of the porous body material 538, such as around the portion of the body material 538 adjacent to the opening 506.

[0167] In an embodiment, the fluid collection assembly 500 include flexible gooseneck tubing 555. The gooseneck tubing 555 may be disposed over the conduit 514 (as shown) or in the conduit 514. The gooseneck tubing 555 may be a modular hose that is capable of manipulation responsive to external forces and rigid retention of a selected configuration after manipulation. For example, the gooseneck tubing 555 may include a ball and socket construction such as a Loc-Line® type modular hose or the like. The size of the balls and sockets of the gooseneck tubing 555 provide a selected fit therebetween (e.g., slip fit, interference fit, etc.) to provide a selected amount of resistance to deformation. Accordingly, the gooseneck tubing 555 may be selectively shaped (e.g., deformed) and retain the selected shape or conformation. In some examples, the gooseneck tubing 555 may be constructed of polymer balls and sockets. It is noted that the gooseneck tubing 555 may be used in any of the fluid collection assemblies disclosed herein.

[0168] Further examples of gooseneck tubing that may be used in the fluid collection assembly 555 or any of the fluid collection assemblies disclosed herein are disclosed in U.S. Patent No. 11,865,030 issued on January 9, 2024, U.S. Patent Application No. 17 / 013,822 filed on September 7, 2020, and U.S. Patent 11,839,567 issued on December 12, 2023, the disclosure of each of which are incorporated herein, in its entirety, by this reference.

[0169] In an embodiment, fluid collection assembly 500 includes an adhesive securement feature secured or securable to the fluid impermeable barrier 502 and configured to attach the fluid collection assembly 502 to an individual. The one or more adhesive securement features may be positioned on at least one of the fluid impermeable barrier 502 or the conduit 514 of the fluid collection assembly 500 resulting in the technical effect of attaching the one or more adhesive securement features to the abdominal, pubic, or pelvic area of the user. Once attached to the user, the one or more adhesive securement features also may provide the technical effectof preventing dislodgement of the fluid collection assembly 500 from the desired position against the user. For example, the fluid collection assembly 100 includes one or more (e.g., two) arms 557 or wings configured to attach or secure the fluid collection assembly 100 to an individual. The arms 557 may each include an adhesive surface oriented towards the opening 506 or generally in the same direction as the opening 506 is oriented. The adhesive surface may include an adhesive material, such as a glue, contact adhesive, epoxy, hydrogel adhesive, tape, an acrylic adhesive, a silicone adhesive, a hydrogel adhesive, other adhesives suitable for placement on the body of a user or fabric worn by the user, or any combination thereof. For example, the adhesive may include an acrylate (e.g., methacrylate or epoxy diacrylate) or any other adhesive suitable for use on bandages. The arms 557 also may include a removable cover secured to the adhesive layer that may be removed prior to securing the adhesive layer to the user.

[0170] The adhesive surface of each of the arms 557 may attach the fluid collection assembly 500 to the individual, and the arms 557 also may include a non-adhesive surface opposite or distal to the adhesive surface. The adhesive surface may attach directly to the skin of the individual or may attach to the fabric worn by the individual, such as undergarments. The arms 557 may be positioned at various areas on the fluid collection assembly 500 to secure the fluid collection assembly 500 directly to a predetermined area of the body of the individual, such as the abdominal region, the pubic region, the pelvic region, the hypogastrium (or hypogastric) region, the legs (including thighs) of the individual, or any combination thereof. For example, the arms 557 are positioned on the fluid collection assembly 500 to provide the technical effect of attaching the adhesive surface of each of the arms 555 to the pelvic region of the individual. The pelvic region may include the area of the individual between the abdomen and the pubic bone or labia of the individual.

[0171] In some embodiments, the two arms 557 are positioned on the fluid collection assembly 100 on a rear or back surface of the fluid impermeable barrier 502, generally distal to the opening 506. In other embodiments, the two arms 557 may be positioned at various positions on the rear or back surface of the fluid impermeable barrier 502. In some embodiments (not shown), the two arms 557 may be positioned on the fluid collection assembly on a front surface of the fluid impermeable barrier 502.

[0172] Further examples of arms or adhesive securement features that may be used in any of the fluid collection assemblies disclosed herein are disclosed in U.S. Patent Application No. 18 / 006,807 filed on January 25, 2023, the disclosure of which is incorporated herein, in its entirety, by this reference.

[0173] FIG. 6 is an isometric view of a fluid collection assembly 600, according to an embodiment. Except as otherwise disclosed herein, the fluid collection assembly 600 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 600 may include a fluid impermeable barrier 602 defining a chamber (not labeled, occupied), an opening 604, and a fluid outlet 606. The fluid collection assembly 600 also includes at least one porous material 608 disposed in the chamber and a conduit 610 extending through the fluid outlet 606 that is in fluid communication with the chamber.

[0174] Unlike the fluid collection assemblies illustrated in FIGS. 2A-5B, the porous material 608 may exhibit a generally sheet-like shape. The porous material 608 may include any of the porous materials disclosed herein. In an example, the porous material 608 may include a single porous material, two porous materials, three porous materials, or four or more porous materials. In an example, the porous material 608 may include at least one surfactant disposed thereon, such as at least one surfactant (e.g., any of the surfactants disclosed herein) disposed on at least an outer surface 603 of the porous material 608.

[0175] The fluid collection assembly 600 may be configured to switch at least between a first state and a second state. The fluid collection assembly 600 may exhibit the first state (as shown) when the fluid collection assembly 600 exhibits a generally sheet-like shape. The fluid collection assembly 600 may exhibit the second state (not shown) when the fluid collection assembly 600 is folded and exhibits a generally U-like shape. The generally U-like shape of the fluid collection assembly 600 may help the fluid collection assembly 600 fit between the thighs of an individual. It is noted that the porous material 608 may exhibit a generally U-like shape when the fluid collection assembly 600 is in the second state. The fluid collection assembly 600 may switch between the first and second states by folding and unfolding the fluid collection assembly 600.

[0176] FIGS. 7A and 7B are top isometric and bottom isometric views of a fluid collection assembly 700, respectively, according to an embodiment. Except as otherwise disclosed herein,the fluid collection assembly 700 may be the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 700 may include a fluid impermeable barrier 702 defining a chamber (not labeled, occupied), an opening 704, and a fluid outlet 706. The fluid collection assembly 700 also includes at least one porous material 708 disposed in the chamber and a conduit 710 extending through the fluid outlet 706 that is in fluid communication with the chamber.

[0177] The porous material 708 includes a sheet portion 712 exhibiting a generally sheet-like shape. In an embodiment, the porous material 708 may include an overhanging portion 714 that overhands a portion of the sheet portion 712. The porous material 708 may include any of the porous materials disclosed herein. In an example, the porous material 708 may include a single porous material, two porous materials, three porous materials, or four or more porous materials. In an example, the porous material 708 may include at least one surfactant disposed thereon, such as at least one surfactant (e.g., any of the surfactants disclosed herein) disposed on at least an outer surface 703 of the porous material 708. In an embodiment, the fluid impermeable barrier 702 only extends along a portion of a back side of the porous material 708.

[0178] The fluid collection assembly 700 may include a base 716 that is configured to attach the fluid collection assembly 700 to an individual. The base 716 may be substantially similar to any of the bases disclosed herein and / or the other adhesive securement features disclosed herein.

[0179] The conduit 710 may extend through the fluid outlet 706 to allow the conduit 710 to be in fluid communication with the chamber. In an embodiment, the conduit 710 may separate into two or more branches. The branches may allow the conduit 710 to receive bodily fluids from a plurality of locations in the porous material 708.

[0180] The fluid collection assemblies illustrated in FIGS. 2A-7B are examples of female fluid collection assemblies. The porous materials including a surfactant disposed in at least a portion thereof may also be used in male fluid collection assemblies. FIGS. 8-10C illustrate different male fluid collection assemblies that may include a porous material including a surfactant disposed therein or any of the other features disclosed herein.

[0181] FIG. 8 is a cross-sectional view of a fluid collection assembly 800, according to an embodiment. The fluid collection assembly 800 includes a base 802 (e.g., annular base) and a sheath 804. The base 802 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 positionedtherethrough. For example, the base 802 may define an aperture 806. The base 802 is sized and shaped to be positioned around the male urethral opening (e.g., positioned around and / or over the penis) and the aperture 806 may be configured to have the male urethral opening positioned therethrough. The base 802 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 802 may exhibit the general shape or contours of the skin surface that the base 802 is selected to be coupled with. The base 802 may be flexible thereby allowing the base 802 to conform to any shape of the skin surface. The base 802 may include a laterally (e.g., radially) extending flange. The base 802 also defines a hollowed region that is configured to receive (e.g., seal against) the sheath 804. For example, the base 802 may include a longitudinally extending flange that extends upwardly from the base 802. The longitudinally extending flange may be tall enough to prevent the sheath 804 from being accidentally removed from the base 802 (e.g., at least 0.25 cm tall, 1 cm tall, at least 3 cm tall, or at least 5 cm tall). The base 802 is located at a proximal end region 824 (with respect to a wearer) of the fluid collection assembly 800.

[0182] The sheath 804 includes (e.g., may be formed from) a fluid impermeable barrier 808 that is sized and shaped to fit into the hollowed region of the base 802. For example, the sheath 804 may be generally tubular or cup-shaped, as shown. The generally tubular or cup-shaped fluid impermeable barrier 808 may at least partially define the outer surface of the sheath 804. The fluid impermeable barrier 808 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 808 may be constructed of any of the materials disclosed herein for the fluid impermeable barrier. The fluid impermeable barrier 808 at least partially defines the chamber 810. For example, the inner surface of the fluid impermeable barrier 808 at least partially defines the perimeter of the chamber 810. The chamber 810 may at least temporarily retain bodily fluids therein. As shown, the fluid collection assembly 800 may include the porous material 812 therein. The porous material 812 may be similar or identical any of the porous materials disclosed herein, in one or more aspects. For example, as shown, the porous material 812 may include one or more of a porous membrane material 814 or a porous body material 816. The porous membrane material 814 may include at least one surfactant (e.g., any of the surfactants disclosed herein) disposed therein. In other words, the porous membrane material 814 may bethe same as or substantially similar to the porous body 101 of FIG. 1. It is noted that the porous material 812 may include a single layer (similar to the porous material 210 of FIGS. 2A-2D) or three or more layers (similar to the porous material 410 of FIGS. 4A-4C). The fluid impermeable barrier 808 may also define an opening 818 extending through the fluid impermeable barrier 808 that is configured to have a male urethral opening positioned therethrough.

[0183] The sheath 804 also includes at least a portion of the conduit 820 therein, such as at least partially disposed in the chamber 810. For example, the conduit 820 may extend from the sheath 804 at the distal end region 822 to a proximal end region 824 at least proximate to the opening 818. The proximal end region 824 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 818 against the skin of the subject. The bodily fluids may be removed from the chamber 810 via the conduit 820.

[0184] In some examples, the fluid impermeable barrier 808 may be constructed of a material and / or have a thickness that allows the sheath 804 to collapse when placed under vacuum, such as to remove air around a penis in the fluid collection assembly 800 during use. In such examples, the conduit 820 may extend only to or into the distal end region 822 in the chamber 810 (e.g., not through to the area adjacent the opening 818). In such examples, urine may be collected and removed from the fluid collection assembly 800

[0185] In an example, portions of the chamber 810 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 810 (e.g., periphery of the interior regions of the sheath 804) may include the porous material 812 (e.g., one or more of the porous membrane material 814 and porous body material 816). For example, the porous material 812 may be bonded to the inner surface of the fluid impermeable barrier 808. The porous material 812 may be positioned (e.g., at the distal end of the chamber 810) 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 810. Since the chamber 810 is substantially empty (e.g., substantially all of the chamber 810 forms a reservoir), the bodily fluids are likely to pool at a gravimetrically low point of the chamber 810. The gravimetrically low point of the chamber 810 may be at an intersection of the skin of anindividual and the fluid collection assembly 800, a corner formed in the sheath 804, or another suitable location depending on the orientation of the wearer.

[0186] The porous material 812 may include one or more of the porous membrane material 814 or the fluid permeable body 816. The porous membrane material 814 and the porous body material 816 may be similar or identical to any of the porous membrane material s and the porous body material s, respectively disclosed herein, in one or more aspects. One or more of the porous membrane material 814 or the porous body material 816 may be disposed between the fluid impermeable barrier 808 and a penis inserted into the chamber 810. The porous membrane material 814 may be positioned between the fluid impermeable barrier 808 and a penis inserted into the chamber 810, such as between the porous body material 816 and penis of a wearer as shown. The porous body material 816 may be positioned between the porous membrane material 814 and the fluid impermeable barrier 808. The inner surface, optionally including the end of the chamber 810 substantially opposite the opening 818, may be covered with one or both of the porous membrane material 814 or the porous body material 816. The porous body material 816 or the porous membrane material 814 may be affixed (e.g., adhered) to the fluid impermeable barrier 808. The porous body material 816 or the porous membrane material 814 may be affixed to each other. In some examples, the porous material 812 only includes the porous membrane material 814 or the porous body material 816.

[0187] The fluid collection assembly 800 includes a cap 826 at a distal end region 822. The cap 826 defines an interior channel through which the bodily fluids may be removed from the fluid collection assembly 800. The interior channel is in fluid communication with the chamber 810. The cap 826 may be disposed over at least a portion of the distal end region 822 of one or more of the fluid impermeable barrier 808 or the porous material 812. The cap 826 may be made of a polymer, rubber, or any other fluid impermeable material. The cap 826 may be attached to one or more of the fluid impermeable barrier 808, the porous material 812, or the conduit 820. The cap 826 may cover at least a portion of the distal end region 822 of the fluid collection assembly 800. The cap 826 may define a fluid outlet 828 that is sized and configured to receive and fluidly seal against the conduit 820. The conduit 820 may extend a distance within or through the cap 826, such as to the porous material 812, through the porous material 812, or to a point set-off from the porous material 812.

[0188] The reservoir 830 is an unoccupied portion of device such as in the cap 826 and is void of other material. In some examples, the reservoir 830 is defined at least partially by the porous material 812 and the cap 826. During use, the bodily fluids that are in the chamber 810 may flow through the porous material 812 to the reservoir 830. The reservoir 830 may store at least some of the bodily fluids therein and / or position the bodily fluids for removal by the conduit 820. In some examples, at least a portion of the porous material 812 may extend continuously between at least a portion of the opening of the interior channel and chamber 810 to wick any bodily fluids from the opening directly to the reservoir 830.

[0189] In some examples (not shown), the fluid impermeable barrier 808 may be disposed on or over the cap 826, such as enclosing the cap 826 within the chamber 810.

[0190] The proximal end region 824 may be disposed near or on the skin around the male urethral opening (e.g., around the penis) and the inlet of the conduit 820 may be positioned in the proximal end region 824. The outlet of the conduit 820 may be directly or indirectly coupled to a vacuum source. Accordingly, bodily fluids may be removed from the proximal end region 824 of the chamber 810 via the conduit 820.

[0191] The base 802, the sheath 804, the cap 826, and the conduit 820 may be attached together using any suitable method. For example, at least two of the base 802, the sheath 804, the cap 826, or the conduit 820 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.

[0192] In some examples (not shown), the fluid collection assembly 800 may have a one- piece design, with one or more of the sheath 804, the base 802, and the cap 826 being a single, integrally formed piece.

[0193] Also as shown, the conduit 820 may be at least partially disposed with the chamber of a fluid collection assembly. The conduit 820 may extend from the distal end region 822 to the proximal end region 824. For example, the conduit 820 may extend through the cap 826 to a point adjacent to the base 802. The conduit 820 is sized and positioned to be coupled to a fluid storage container or the vacuum source (FIG. 11). An outlet of the conduit 820 may be operably coupled to the vacuum source, directly or indirectly. The inlet of the conduit 820 may be positioned within the chamber 810 such as at a location expected to be at the gravimetrically low point of the fluid collection assembly during use. By positioning the inlet in a location expectedto be at the gravimetrically low point of the fluid collection assembly when worn by the user, bodily fluids introduced into the chamber 810 may be removed via the conduit 820 to prevent pooling or stagnation of the bodily fluids within the chamber 810.

[0194] In some examples, the vacuum source may be remotely located from the fluid collection assembly 800. In such examples, the conduit 820 may be fluidly connected to the fluid storage container, which may be disposed between the vacuum source and the fluid collection assembly 800.

[0195] During operation, a male using the fluid collection assembly 800 may discharge bodily fluids (e.g., urine) into the chamber 810. The bodily fluids may pool or otherwise be collected in the chamber 810. At least some of the bodily fluids may be pulled through the interior of the conduit 820 via the inlet. The bodily fluids may be drawn out of the fluid collection assembly 800 via the vacuum / suction provided by the vacuum source. During operation, the vacuum relief valve may substantially maintain the pressure in the chamber 810 at atmospheric pressure even though bodily fluids is introduced into and subsequently removed from the chamber 810.

[0196] FIG. 9 is a front view of a male urine collection device 900, according to an embodiment. The urine collection device 900 includes a fluid impermeable barrier 902 at least partially defining an opening 906 and a chamber within the fluid collection assembly in fluid communication with the opening 906. In some embodiments, a bottom portion of the fluid impermeable barrier 902 may define the opening 906 and an opposite or a top portion of the fluid impermeable barrier 902 may define a fluid outlet 912. The fluid impermeable barrier 902 includes a proximal end region 903 and a distal end region 905. The opening 906 may be positioned proximate or closer to the proximal end region 903 than the distal end region 905 of the fluid impermeable barrier 902, and the fluid outlet 912 may be positioned proximate or closer to the distal end region 905 than the proximal end region 903. In some embodiments, the fluid impermeable barrier 902 narrows between the proximal end region 903 and the distal end region 905. For example, the fluid impermeable barrier 902 (and the chamber) may include a substantially triangular front profile, with the distal end region 905 being at the narrow end or tip of the triangular profile. The fluid impermeable barrier 902 may include a shape substantially complementary to the chamber, such as a substantially triangular front profile. The fluid impermeable barrier 902 may include a substantially flexible fluid impermeable material, such asa fluid impermeable polymer e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, a polycarbonate, etc.), polyurethane films, thermoplastic elastomer, oil, another suitable material, or combinations thereof. In some embodiments, the fluid impermeable barrier includes a paper-like or bag-like fluid impermeable material and / or a fluid impermeable fabric.

[0197] The urine collection device 900 also includes a porous material 910 positioned within the chamber and extending at least partially between the distal end region 905 and the proximal end region 903. The porous material 910 may be shaped generally complementary to the shape of the chamber of the fluid impermeable barrier 902. In some embodiments, the porous material 910 is spaced from the edges of the fluid impermeable barrier 902 that extend at least partially between the distal end region 905 and the proximal end region 903. In some embodiments, the porous material 910 is positioned to abut the edges of the fluid impermeable barrier 902 such that fluid impermeable barrier 902 retains fluid in the porous material 910 from the opening 906 to the sump 909.

[0198] The porous material 910 can be configured to wick and / or allow transport of fluid away from the opening 906, thereby preventing the fluid from escaping the chamber. The porous material 910 also can wick and / or allow transport of the fluid generally towards the sump 909. The porous material 910 may include any of the porous materials disclosed herein. In an embodiment, the porous material 910 may include at least one surfactant (e.g., any of the surfactants disclosed herein) extending inwardly from and / or disposed on an outer surface (not labeled, a surface of the porous material 910 that contacts the penis disposed in the chamber). In other words, the porous material 910 may be the same as or substantially similar to the porous body 101 of FIG. 1. In an embodiment, the porous material 910 can include a one-way fluid movement fabric. As such, the porous material 910 can remove fluid from the area around the penis, thereby leaving the area and urethra dry. The porous material 910 can enable the fluid to flow generally towards the sump 909 and the tube 908 within the chamber. The porous material 910 can include a porous or fibrous material, such as hydrophilic polyolefin. In some embodiments, the porous material 910 consists of or consists essentially of a porous or fibrous material, such as hydrophilic polyolefin. Examples of polyolefin that can be used in the porous material 910 include, but are not limited to, polyethylene, polypropylene, polyisobutylene, ethylene propylene rubber, ethylene propylene diene monomer, or combinations thereof. Moreover, the porous material 910 can be manufactured according to various manufacturingmethods, such as molding, extrusion, or sintering. The porous material 910 can include varying densities or dimensions.

[0199] In some embodiments, the porous material 910 can include two or more layers of fluid permeable materials. For example, the porous material 910 can include a porous membrane material (e.g., that includes at least one surfactant disposed therein) covering or wrapped around a porous body material, with both the porous membrane material and the porous body material being disposed in the chamber. The porous membrane material can cover or extend across at least a portion (e.g., all) of at least the side of the porous body material facing the penis of the user. The porous membrane material and the porous body material can be configured to wick any fluid away from the opening 906, thereby preventing the fluid from escaping the chamber and promoting removal of the fluid through the tube 908. The permeable properties referred to herein can be wicking, capillary action, diffusion, or other similar properties or processes, and are referred to herein as “permeable” and / or “wicking.”

[0200] The porous membrane material and the porous body material also can wick the fluid generally towards an interior of the chamber, such as the sump 909. The porous membrane material can include any material that can wick the fluid. For example, the porous membrane material can include fabric, such as a gauze (e.g., a silk, linen, polymer based materials such as polyester, or cotton gauze), nylon (such as a spun nylon fibers), another soft fabric (e.g., jersey knit fabric or the like), or another smooth fabric (e.g., rayon, satin, or the like). Forming the porous membrane material from gauze, soft fabric, and / or smooth fabric can reduce chaffing caused by the urine collection device 900. Other embodiments of porous membrane materials and porous body materials are disclosed in U.S. Patent Application No. 15 / 612,325 filed on June 7, 7017; U.S. Patent Application No. 15 / 260,103 filed on September 8, 7016; U.S. Patent Application No. 15 / 611,587 filed on June 1, 7017; PCT Patent Application No. PCT / US19 / 29608, filed on April 79, 7019, the disclosure of each of which is incorporated herein, in its entirety, by this reference. In many embodiments, the porous material 910 includes a porous body material including a porous spun nylon fiber structure and a fluid permeable wicking membrane including gauze at least partially enclosing the spun nylon fiber structure.

[0201] The urine collection device 900 also includes a tube 908 extending into the chamber and having an end 918 positioned proximate to the distal end region 905 of the fluid impermeable barrier 902. In an embodiment, the tube 908 includes a tube opening proximate tothe end of the tube 908. The sump 909 may be defined as the region or area between the tube opening 906 and the distal end region 905 of the fluid impermeable barrier 902. At least some of the porous material 910 may extend into the sump 909. Fluid discharged on the porous material 910 may flow to and pool in the sump 909 for removal when a vacuum is applied on the tube 908. The tube 908 may extend through a fluid outlet 912 in the distal end region 905 of the fluid impermeable barrier 902 and into the chamber.

[0202] As urine is discharged onto the porous material 910, the urine may flow to the lowest point to form a pool of urine at the distal end region 905 of the fluid impermeable barrier 902. In an embodiment, the end of the tube 908 and the tube opening are spaced from the distal end region 905 of the fluid impermeable barrier 902 such that a sump 909 for the pool of urine is defined between the tube opening and / or the end of the tube 908.

[0203] In some embodiments, the distal portion of the porous material 910 is shaped substantially complementary to the distal end region 905. The distal portion 925 of the porous material 910 may be spaced from the distal end region 905 of the fluid impermeable barrier 902, such that a portion of the sump 909 is devoid of the porous material 910. In some embodiments, the distal portion of the porous material 910 interfaces at least a portion (e.g., all) of the fluid impermeable barrier 902 at the distal end region 905.

[0204] FIG. 10A is an isometric view of a fluid collection assembly 1000, according to an embodiment. FIGS. 10B and 10C are cross-sectional views of the fluid collection assembly 1000 taken along planes 10B-10B and 10C- 10C, respectively, shown in FIG. 10A. Except as otherwise disclosed herein, the fluid collection assembly 1000 is the same as or substantially similar to any of the fluid collection assemblies disclosed herein. For example, the fluid collection assembly 1000 includes sheath 1001 including a fluid impermeable barrier 1002. The fluid impermeable barrier 1002 at least defines a chamber 1004, at least one opening 1006, and a fluid outlet 1008. The fluid collection assembly 1000 also includes at least one porous material 1010 disposed in the chamber 1004 that extends at least adjacent to the opening 1006. The porous material 1010 may include any of the porous materials disclosed herein, such as a porous material including at least one surfactant (e.g., any of the surfactants disclosed herein) extending from an outer surface thereof. The fluid collection assembly 1000 also includes a base 1003.

[0205] The fluid outlet 1008 may be located at or near the proximal end region 1012 of the sheath 1001. A conduit 1014 may extend through the fluid outlet 1008 into the chamber 1004.The conduit 1014 may include a plurality of branches in the chamber 1004 extending from the primary portion of the conduit 1014 that extends through the fluid outlet 1008. For example, the conduit 1014 may include branches that extend along an outer periphery of the chamber 1004. The branches may extend to or near the distal end region 1013.

[0206] The fluid impermeable barrier 1002 may include one or more folds 1016 formed therein. The folds 1016 may allow the volume of the fluid impermeable barrier 1002 to expand as a penis is inserted into the chamber 1004 and / or the penis disposed in the chamber 1004 changes sizes (e.g., becomes erect or flaccid).

[0207] Additional examples of fluid collection assemblies that may include any of the features disclosed herein, such as a porous body that includes at least one surfactant disposed in at least a portion thereof, are disclosed in U.S. Patent No. 11,504,265 issued on November 22, 2022, U.S. Patent No. 10,390,989 issued on August 27, 2019, U.S. Patent Application No. 17 / 996,155 filed on April 15, 2021, U.S. Patent Application No. 18 / 249,577 filed on October 19,2021, U.S. Patent Application No. 18 / 563,672 filed on June 7, 2022, International Application No. PCT / US2022 / 022111 filed on March 28, 2022, U.S. Patent Application No. 17 / 996,253 filed on April 14, 2021, International Application No. PCT / US2023 / 031432 filed on August 29, 2023, International Application No. PCT / US2023 / 36875 filed on November 6, 2023, U.S. Provisional Patent Application No. 63 / 596,012 filed on November 3, 2023, U.S. Patent Application No. 17 / 444,792 filed on August 10, 2021, International Application No. PCT / US2022 / 018170 filed on February 28, 2022, International Application No. PCT / US2022 / 019254 filed on March 8,2022, U.S. Patent Application No. 16 / 478,180 filed on January 30, 2018, U.S. Patent No. 10,973,678 filed on June 2, 2017, U.S. Patent Application No. 17 / 614,173 filed on May 15, 2020, U.S. Patent Application No. 18 / 003,029 filed on June 30, 2021, U.S. Patent No. 11,925,575 issued on March 12, 2024, U.S. Patent Application No. 18 / 164,800 filed on February 6, 2023, International Application No. PCT / US2023 / 025192 filed on June 13, 2023, and International Application No. PCT / US2023 / 030365 filed on August 16, 2023, the disclosure of each of which is incorporated herein, in its entirety, by this reference.

[0208] FIG. 11 is a block diagram of a fluid collection system 1170 for fluid collection, according to an embodiment. The fluid collection system 1170 includes a fluid collection assembly 1100, a fluid storage container 1172, and a vacuum source 1174. The fluid collection assembly 1100 may be the same or substantially similar to any of the fluid collection assembliesdisclosed herein. The fluid collection assembly 1100, the fluid storage container 1172, and the vacuum source 1174 may be fluidly coupled to each other via one or more conduits 1176. For example, fluid collection assembly 1100 may be operably coupled to one or more of the fluid storage container 1172 or the vacuum source 1174 via the conduit 1176. The bodily fluids collected in the fluid collection assembly 1100 may be removed from the fluid collection assembly 1100 via the conduit 1176 which protrudes into the fluid collection assembly 1100. For example, an inlet of the conduit 1176 may extend into the fluid collection assembly 1100, such as to a reservoir therein. The outlet of the conduit 1176 may extend into the fluid collection assembly 1100 or the vacuum source 1174. Suction force may be introduced into the chamber of the fluid collection assembly 1100 via the inlet of the conduit 1176 responsive to suction (e.g., vacuum) force applied at the outlet of the conduit 1176.

[0209] The suction force may be applied to the outlet of the conduit 1176 by the vacuum source 1174 either directly or indirectly. The suction force may be applied indirectly via the fluid storage container 1172. For example, the outlet of the conduit 1176 may be disposed within the fluid storage container 1172 and an additional conduit 1176 may extend from the fluid storage container 1172 to the vacuum source 1174. Accordingly, the vacuum source 1174 may apply suction to the fluid collection assembly 1100 via the fluid storage container 1172. The suction force may be applied directly via the vacuum source 1174. For example, the outlet of the conduit 1176 may be disposed within the vacuum source 1174. An additional conduit 1176 may extend from the vacuum source 1174 to a point outside of the fluid collection assembly 1100, such as to the fluid storage container 1172. In such examples, the vacuum source 1174 may be disposed between the fluid collection assembly 1100 and the fluid storage container 1172.

[0210] The fluid storage container 1172 is sized and shaped to retain bodily fluids therein. The fluid storage container 1172 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 1176 may extend from the fluid collection assembly 1100 and attach to the fluid storage container 1172 at a first point therein. An additional conduit 1176 may attach to the fluid storage container 1172 at a second point thereon and may extend and attach to the vacuum source 1174. Accordingly, a vacuum (e.g., suction) may be drawn through fluid collection assembly 1100 via the fluid storage container 1172. Bodily fluids, such as urine, may be drained from the fluid collection assembly 1100 using the vacuum source 1174.

[0211] The vacuum source 1174 may include one or more of a manual vacuum pump, and electric vacuum pump, a diaphragm pump, a centrifugal pump, a displacement pump, a magnetically driven pump, a peristaltic pump, or any pump configured to produce a vacuum. The vacuum source 1174 may provide a vacuum or suction to remove bodily fluids from the fluid collection assembly 1100. In some examples, the vacuum source 1174 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 1174 may be sized and shaped to fit outside of, on, or within the fluid collection assembly 1100. For example, the vacuum source 1174 may include one or more miniaturized pumps or one or more micro pumps. The vacuum sources 1174 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 1174.

[0212] The following working examples set forth examples of porous materials including at least one surfactant. In particular, the ability of porous materials including various surfactants to receive bodily fluids quickly and effectively without leaking is compared.WORKING EXAMPLES 1-3

[0213] Several polypropylene sheets were provided. Each of the polypropylene sheets were heated in an oven at 60 °C for an hour and then allowed to cool to room temperature. The weight of nine of the polypropylene sheets were determined after the polypropylene sheets were cooled. Several of the polypropylene sheets had a mixture of different PEGFA surfactants (Stantex S 6887) applied thereto. Several of the polypropylene sheets had a first proprietary anionic surfactant applied thereto. The first proprietary anionic surfactant was a fatty acid potassium. Several of the polypropylene sheets had a second proprietary anionic surfactant applied thereto. The second proprietary anionic surfactant included Silastol™ 163 (available from Schill & Seilacher of Germany, dioctyl sodium sulfosuccinate). After applying the surfactants to the polypropylene sheets, three of each type of the polypropylene sheets (nine total) were flash dried in a hood for 45 minutes, heated in an oven to 60 °C for 1 hour, and allowed to cool to room temperature. Each of the nine polypropylene sheets were weighted after cooling to room temperature. Using the weights of the polypropylene sheets before and after applying the surfactants thereto, it was determined that the average weight percent of the PEGFA surfactants in the three polypropylene sheets that included the PEGFA surfactants was 0.49 wt%, theaverage weight percent of the first anionic surfactant in the three polypropylene sheets that included the first anionic surfactants was 0.25 wt%, and the average weight percent of the second anionic surfactant in the three polypropylene sheets that included the second anionic surfactant was 0.38 wt%.

[0214] Working Examples 1-3 each included a porous material exhibiting the general structure illustrated in FIGS. 4A-4C. In particular, the porous material of each of Working Examples 1-3 included a polyethylene terephthalate inner, support layer and a bamboo intermediate layer. The porous materials of Working Example 1 each included one of the polypropylene sheets including the PEGFA surfactants forming the outer layer. The porous materials of Working Example 2 each included the polypropylene sheets including one of the first anionic surfactant forming the outer layer. The porous materials of Working Example 2 each included one of the polypropylene sheets including the second anionic surfactant forming the outer layer. Working Examples 1-3 were formed into a fluid collection assemblies by positioning the porous materials thereof in a fluid impermeable barrier and inserting a conduit through a fluid outlet into the chamber defined by the fluid impermeable barrier and through a bore defined by the porous materials. In other words, the fluid collection assemblies of Working Examples 1-3 exhibited the general structure illustrated in FIGS. 4A-4C.

[0215] The wicking ability of some of the fluid collection assemblies of Working Examples 1-3 were tested shortly after disposing the surfactants on the polypropylene sheets (labeled “new” on FIG. 12). To test the wicking ability of these fluid collection assemblies, the fluid collection assemblies were individually positioned on an anatomical model of a vaginal region with the porous material disposed between the labia folds of the model. The conduit was connected to a vacuum source and a vacuum of 40 mmHg was provided to the chamber of the fluid collection assembly. 500 ml of water was then pumped from a reservoir and out of the urethral opening of the anatomical model at 18 ml / s which is the average rate of urine discharge from women aged 18 to about 80 years old. A container was positioned under the anatomical model to catch any water that leaked from the fluid collection assembly. The results are illustrated in FIG. 12 and will be discussed below.

[0216] The wicking ability of the remainder of the fluid collection assemblies of Working Examples 1-3 were tested after subjecting the fluid collection assemblies to an accelerated aging process (labeled “aged” on FIG. 12). The accelerated aging process mimicked aging the fluidcollection assemblies for one year and included heating the fluid collection assemblies at 90 °C. The wicking ability of these fluid collection assemblies were tested using the same process discussed above.

[0217] Referring to FIG. 12, the fluid collection assemblies of Working Examples 1-3 that were tested shortly after disposing the surfactant on the polypropylene sheet captured almost all of the water discharged from the anatomical model with the average capture rate for each of Working Examples 1-3 being greater than 99%. The capture rate of the fluid collection assemblies of Working Examples 1-3 that were tested shortly after disposing the surfactant on the polypropylene liner far exceeded the minimum acceptable capture rate of 93%. This demonstrates that disposing surfactants on the polypropylene sheets causes the polypropylene sheets to receive bodily fluids quickly and effectively, at least for a short time after applying the surfactant to the polypropylene sheets.

[0218] The fluid collection assemblies of Working Example 1 that was subjected to accelerated aging process also exhibited a capture rate that far exceeded 93% and was only slightly worse than the capture rate of the fluid collection assemblies of Working Example 1 that were tested shortly after disposing the surfactant on the polypropylene sheet. It is currently believed that the superior performance of the fluid collection assemblies of Working Example 1 that were subjected to the accelerated aging process is because the PEGFA surfactants remained in the polypropylene sheet and did not migrate therefrom. The fluid collection assemblies of Working Examples 2 and 3 that was subjected to accelerated aging process exhibited a capture that that was below 93% and significantly worse than the capture rate of the fluid collection assemblies of Working Examples 2 and 3 that were tested shortly after disposing the surfactant on the polypropylene sheet. It is believed that the inferior performance of the fluid collection assemblies of Working Examples 2 and 3 that was subjected to accelerated aging process is because the surfactants thereof migrated from the polypropylene sheet leaving little if any surfactant in the polypropylene sheet.

[0219] 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.

[0220] 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 witha 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.1

Claims

CLAIMSWhat is claimed is:

1. A fluid collection assembly, comprising: a fluid impermeable barrier at least defining a chamber, at least one opening, and a fluid outlet; at least one porous material disposed in the chamber; and at least one surfactant disposed on at least a portion of the at least one porous material.

2. The fluid collection assembly of claim 1, wherein the at least one porous material includes a single layer of porous material.

3. The fluid collection assembly of claim 1, wherein the at least one porous material includes a porous body material and a porous membrane material disposed on at least a portion of the porous body material, the at least one surfactant is disposed on the porous membrane material.

4. The fluid collection assembly of claim 1, wherein the at least one porous material includes an inner layer, an outer layer, and an intermediate layer between the inner layer and the outer layer, wherein the at least one surfactant is disposed on at least a portion of the outer layer.

5. The fluid collection assembly of claim 4, wherein the outer layer exhibits a base weight of 10 grams per square meter to 35 grams per square meter.

6. The fluid collection assembly of any one of claims 4 or 5, wherein the at least one surfactant is present in substantially all of the outer layer.

7. The fluid collection assembly of any one of claims 4-6, wherein the outer layer includes a hydrophobic porous material.

8. The fluid collection assembly of any one of claims 4-7, wherein the intermediate layer includes bamboo.

9. The fluid collection assembly of any one of claims 4-8, wherein the inner layer includes non-woven polyethylene terephthalate.

10. The fluid collection assembly of any one of claims 1-9, wherein the at least one porous material includes polypropylene.

11. The fluid collection assembly of claim 1-10, wherein the at least one porous material includes polyethylene, polyester, nylon, or nitrile.

12. The fluid collection assembly of any one of claims 1-11, wherein the at least one surfactant includes at least one polyethylene glycol fatty acid ester.

13. The fluid collection assembly of claim 12, wherein the at least one polyethylene glycol fatty acid ester includes an aliphatic carbon chain including 8 carbon atoms to 24 carbon atoms.

14. The fluid collection assembly of any one of claims 12 or 13, wherein the at least one polyethylene glycol fatty acid ester includes an aliphatic saturated carbon chain.

15. The fluid collection assembly of any one of claims 12 or 13, wherein the at least one polyethylene glycol fatty acid ester includes an aliphatic unsaturated carbon chain.

16. The fluid collection assembly of any one of claims 12-15, wherein a polyethylene glycol chain of the at least one polyethylene glycol fatty acid ester exhibits a molecular weight of 200 daltons or 4000 daltons.

17. The fluid collection assembly of any one of claims 12-16, wherein the at least one surfactant includes substantially only a single composition of the at least one polyethylene glycol fatty acid ester.

18. The fluid collection assembly of any one of claims 12-16, wherein the at least one surfactant includes a plurality of different compositions of the at least one polyethylene glycol fatty acid ester.

19. The fluid collection assembly of any one of claims 1-18, wherein the at least one surfactant forms about 0.1 wt% to about 2 wt% of at least a portion of the at least one porous material.

20. The fluid collection assembly of any one of claims 1-18, wherein the at least one surfactant forms about 0.2 wt% to about 0.8 wt% of at least a portion of the at least one porous material.

21. A fluid collection system, comprising: the fluid collection assembly of any one of claims 1-20; 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.

22. A method to form a fluid collection assembly, the method comprising: disposing at least one surfactant on at least a portion of at least one porous material; and positioning the at least one porous material in a chamber defined by a fluid impermeable barrier, the fluid impermeable barrier at least defining the chamber, at least one opening, and a fluid outlet.

23. The method of claim 22, wherein disposing at least one surfactant on at least a portion of at least one porous material includes disposing polyethylene glycol fatty acid on at least a portion of the at least one porous material.

24. The method of any one of claims 22 or 23, wherein disposing at least one surfactant on at least a portion of the at least one porous material includes disposing the at least one surfactant on the at least a portion of the at least one porous material using spray coating process or a kiss roll coating process.

25. The method of any one of claims 22-24, wherein disposing at least one surfactant on at least a portion of the at least one porous material includes disposing the at least one surfactant on one side of the at least one porous material.

26. The method of claim 25, further comprising, after disposing at least one surfactant on one side of the at least one porous material, rolling the at least one porous material such that the one side of the at least one porous material that includes the at least one surfactant contacts a side of the at least one porous material that does not include the at least one surfactant.

27. The method of any one of claims 22-26, wherein disposing the at least one surfactant on the at least a portion of the at least one porous material includes disposing a solution including the at least one surfactant on the at least a portion of the at least one porous material.

28. The method of claim 27, wherein the at least one surfactant forms 4 wt% to about 8 wt% of the solution.

29. The method of any one of claims 22-28, wherein the act of disposing the at least one surfactant on the at least a portion of the at least one porous material is performed before the act of positioning the at least one porous material in the chamber.

30. The method of any one of claims 22-28, wherein the act of disposing the at least one surfactant on the at least a portion of the at least one porous material is performed after the act of positioning the at least one porous material in the chamber.

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