Fluid Collection Assembly Including At Least One of Polyurethane Foam and Polyethylene Foam - Patent application

Abstract

The exemplary fluid collection assembly 100 comprises a fluid impermeable barrier 102. The fluid impermeable barrier 102 at least defines a cavity 104, at least one opening 106, and a fluid outlet 108. The fluid collection assembly 100 also comprises at least one porous material 110 disposed within the cavity 104. The porous material 110 comprises at least one of a polyurethane foam or a polyethylene foam. In one embodiment, the porous material 110 comprises an outer layer 112 disposed on an inner layer 114, the outer layer 112 comprising a polyurethane foam and the inner layer 114 comprising a polyethylene foam.

Description

[Technical field]

[0001] The present invention relates to a fluid collection assembly including at least one of polyurethane foam and polyethylene foam. [Background technology]

[0002] A human or animal may have a limitation or impairment in mobility that makes the normal process of urination difficult or impossible. For example, a human may experience or have an impairment that impairs mobility. A human may have limited mobility, such as conditions experienced by pilots, drivers, and workers in hazardous areas. In addition, collection of bodily fluids may be required for monitoring purposes or for clinical testing. Summary of the Invention [Problem to be solved by the invention]

[0003] Urinary catheters, such as Foley catheters, may address some of these conditions, such as incontinence. Unfortunately, urinary catheters can be uncomfortable and painful, and can lead to complications such as infection. In addition, commodes, which are containers used for toileting by bedridden individuals, are sometimes used. However, commodes are prone to discomfort, leakage, and other hygiene problems. [Means for solving the problem]

[0004] Embodiments are directed to a fluid collection assembly including at least one of a polyurethane foam and a polyethylene foam, a fluid collection system including said fluid collection assembly, and methods of using and forming said fluid collection assembly. In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier that at least defines a cavity, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the cavity. The at least one porous material includes a polyurethane foam.

[0005] In one embodiment, a fluid collection assembly is disclosed. The fluid collection assembly includes a fluid impermeable barrier that at least defines a cavity, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the cavity. The at least one porous material includes polyethylene foam.

[0006] In one 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 that at least defines a cavity, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the cavity. The at least one porous material includes at least one of a polyurethane foam and a polyethylene foam. The fluid collection system also includes a fluid reservoir and a vacuum source. The cavity of the fluid collection assembly, the fluid reservoir, and the vacuum source are in fluid communication with each other such that suction force provided from the vacuum source to the cavity removes one or more bodily fluids from the cavity and accumulates the one or more bodily fluids in the fluid reservoir.

[0007] Features from any of the disclosed embodiments may be used in combination with each other without limitation.In addition, other features and advantages of the present disclosure will become apparent to those skilled in the art upon review of the following detailed description and accompanying drawings. [Brief description of the drawings]

[0008] The drawings illustrate several embodiments of the present disclosure, in which the same reference numerals refer to the same or similar elements or features from the various views or in the various embodiments shown in the drawings. [Figure 1A] 1 is a perspective view of a fluid collection assembly according to one embodiment. [Figure 1B] 1B-1B and 1C-1C are cross-sectional schematic views of the fluid collection assembly shown in FIG. 1A, taken along planes 1B-1B and 1C-1C, respectively. [Figure 1C]1B-1B and 1C-1C are cross-sectional schematic views of the fluid collection assembly shown in FIG. 1A, taken along planes 1B-1B and 1C-1C, respectively. [Figure 2A] 1 is a cross-sectional schematic diagram of a fluid collection assembly according to one embodiment. [Figure 2B] 2B is a cross-sectional schematic diagram of the fluid collection assembly taken along plane 2B-2B shown in FIG. 2A. [Diagram 3] FIG. 1 is a cross-sectional view of a male fluid collection assembly according to one embodiment. [Figure 4A] 1 is a perspective view of a fluid collection assembly according to one embodiment. [Figure 4B] FIG. 4B is a cross-sectional schematic view of the fluid collection assembly taken along plane 4B-4B. [Diagram 5] FIG. 1 is a block diagram of a fluid collection system for fluid collection, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Embodiments are directed to a fluid collection assembly including at least one of polyurethane foam and polyethylene foam, a fluid collection system including said fluid collection assembly, and methods of using and forming said fluid collection assembly. An exemplary fluid collection assembly includes a fluid impermeable barrier that at least defines a cavity, at least one opening, and a fluid outlet. The fluid collection assembly also includes at least one porous material disposed in the cavity. The porous material includes at least one of polyurethane foam or polyethylene foam. In one example, the porous material includes an outer layer disposed on a surface of the inner layer, the outer layer including polyurethane foam and the inner layer including polyethylene foam.

[0010] In use, the fluid collection assembly can be placed against an individual such that the opening is positioned adjacent to a female urethral opening or receives a male urethral opening (i.e., the penis). The individual can discharge one or more bodily fluids, such as urine, blood, or sweat. The bodily fluids can flow through the opening and into the porous material. The bodily fluids can be removed from the cavity via the fluid outlet. In one embodiment, suction can be applied to the cavity from a vacuum source, thereby removing the bodily fluids from the cavity.

[0011] Conventional fluid collection assemblies include porous materials other than polyurethane foam and / or polyethylene foam. The porous materials of such conventional fluid collection assemblies may include porous membranes, gauze disposed on a polyethylene terephthalate or spun nylon fiber core, or a cover sheet disposed on a cross-wrapped nonwoven filtration material. However, it has been found that the porous materials used in such conventional fluid collection assemblies may have difficulty initially receiving bodily fluids, which may cause leakage in such conventional fluid collection assemblies when an individual using such conventional fluid collection assemblies discharges a large amount of bodily fluids in a short period of time (e.g., urinates). Furthermore, the porous materials of such conventional fluid collection assemblies are unable to dry quickly, which may cause skin conditions to worsen if such conventional fluid collection assemblies are not replaced relatively frequently (e.g., after at least approximately 12 hours, approximately 18 hours, or approximately 24 hours of use). Other conventional fluid collection assemblies do not include porous materials in an attempt to solve these problems associated with conventional fluid collection assemblies that include porous materials. However, such conventional fluid collection assemblies that do not include porous materials can have difficulty receiving bodily fluids and preventing the fluid from pooling on the individual, which may in any event aggravate the skin condition.

[0012] The fluid collection assemblies disclosed herein provide an improvement over such conventional fluid collection assemblies at least because the fluid collection assemblies include a porous material that includes at least one of polyurethane foam or polyethylene foam. In one embodiment, the polyurethane foam can quickly receive bodily fluids from an individual, even if the individual discharges a large amount of bodily fluids in a short period of time. The polyurethane foam can also feel comfortable against the sensitive skin surrounding the individual's urethral opening (e.g., the vaginal area). In one embodiment, the polyethylene foam can facilitate the movement of bodily fluids through the cavity of the fluid collection assembly to an outlet (e.g., a fluid outlet or an inlet of a conduit disposed through the fluid outlet), thereby allowing the porous material to remain dry. When the porous material includes both polyurethane foam and polyethylene foam, the porous material can quickly receive bodily fluids, can quickly transfer bodily fluids through the cavity, and can be comfortable. Additionally, bodily fluids received within the polyurethane foam can easily flow from the polyurethane foam into the polyethylene foam, which draws bodily fluids from the polyurethane foam that would otherwise remain within the polyurethane foam. Due to the properties of the porous materials disclosed herein, the fluid collection assemblies including at least one of polyurethane foam or polyethylene foam can be used for extended periods of time without causing deterioration of the skin condition. For example, the fluid collection assemblies including at least one of polyurethane foam or polyethylene foam disclosed herein can be used for 24 hours or more, about 30 hours or more, about 36 hours or more, about 42 hours or more, about 48 hours or more, or in the range of about 24 hours to about 36 hours, about 30 hours to about 42 hours, or about 36 hours to about 48 hours.

[0013] FIG. 1A is a perspective view of a fluid collection assembly 100, according to one embodiment. FIGS. 1B-1C are cross-sectional schematic views of the fluid collection assembly 100 along planes 1B-1B and 1C-1C, respectively, shown in FIG. 1A. The fluid collection assembly is an example of a fluid collection assembly configured to receive bodily fluids from a female urethral meatus. The fluid collection assembly 100 comprises a fluid-impermeable barrier 102. The fluid-impermeable barrier 102 at least defines a cavity 104, at least one opening 106, and a fluid outlet 108. The fluid collection assembly 100 also comprises at least one porous material 110 disposed within the cavity 104. In one embodiment, as shown, the porous material 110 comprises an outer layer 112 extending across the opening 106 and an inner layer 114 supporting the outer layer 112 (i.e., the outer layer 112 is disposed on a surface of the inner layer 114). The outer layer 112 may include polyurethane foam and the inner layer 114 may include polyethylene foam, although, as discussed in more detail below, either the outer layer 112 or the inner layer 114 may include a material other than polyurethane foam or polyethylene foam, respectively.

[0014] The fluid-impermeable barrier 102 at least defines a cavity 104 (e.g., an interior region) and an opening 106. The fluid-impermeable barrier 102 temporarily stores bodily fluids in the cavity 104. The fluid-impermeable barrier 102 can be formed of any suitable fluid-impermeable material, such as a fluid-impermeable polymer (e.g., silicone, polypropylene, polyethylene, polyethylene terephthalate, neoprene, polycarbonate, etc.), a thin metal film, natural rubber, another suitable material, any other fluid-impermeable material disclosed herein, or a combination thereof. Thus, the fluid-impermeable barrier 102 substantially prevents bodily fluids from passing through the fluid-impermeable barrier 102. In one embodiment, the fluid-impermeable barrier 102 can be air permeable and fluid-impermeable. In such an embodiment, the fluid-impermeable barrier 102 can be formed of a hydrophobic material that defines a plurality of pores. At least one or more portions of at least one outer surface of the fluid impermeable barrier 102 may be formed from a flexible and / or smooth material, thereby reducing the occurrence of trauma.

[0015] The opening 106 provides an entry route for bodily fluids to enter the cavity 104. The opening 106 may be defined by the fluid-impermeable barrier 102, such as an inner edge of the fluid-impermeable barrier 102. For example, the opening 106 is formed in and extends through the fluid-impermeable barrier 102, thereby allowing bodily fluids to enter the cavity 104 from outside the fluid collection assembly 100.

[0016] In some examples, the fluid impermeable barrier 102 can define a fluid outlet 108 sized to receive a conduit 116. At least one conduit 116 can be disposed within the cavity 104 through the fluid outlet 108. The fluid outlet 108 can be sized and shaped to form an at least substantially fluid-tight seal with the conduit 116 or at least one tube, thereby substantially preventing bodily fluids from escaping the cavity 104.

[0017] As described above, the fluid collection assembly 100 includes a porous material 110 disposed within the cavity 104. The porous material 110 can span at least a portion (e.g., all) of the opening 106. The porous material 110 can include an outer layer 112 and an inner layer 114. The porous material 110 is exposed to an environment outside the cavity 104 through the opening 106.

[0018] As discussed above, the outer layer 112 may include polyurethane foam. In one embodiment, the polyurethane foam may be hydrophilic, which allows the polyurethane foam to quickly draw bodily fluids into itself, thereby preventing or at least inhibiting leakage of bodily fluids that may occur due to the loss of a large amount of bodily fluid in a short period of time. A polyurethane foam can be hydrophilic if it exhibits a contact angle with water (the major component of bodily fluids) that is about 0° to about 10°, about 5° to about 15°, about 10° to about 20°, about 15° to about 25°, about 20° to about 30°, about 25° to about 35°, about 30° to about 40°, about 35° to about 45°, about 40° to about 50°, about 45° to about 55°, about 50° to about 60°, about 55° to about 65°, about 60° to about 70°, about 65° to about 75°, about 70° to about 80°, about 75° to about 85°, or about 80° to about 90°. In general, as the hydrophilicity of a polyurethane foam increases (i.e., the contact angle between the polyurethane foam and water decreases), the amount of bodily fluid that the polyurethane foam can receive in a given period of time increases. However, increasing the hydrophilicity of the polyurethane foam may increase the amount of bodily fluid that may be retained within the polyurethane foam after it receives the bodily fluid. Thus, the hydrophilicity of the polyurethane foam may be selected based on adequately meeting the need to quickly receive bodily fluid while also keeping the porous material 110 dry. For example, a fluid collection assembly 100 configured for short-term use with individuals having large bladders may include a polyurethane foam that exhibits greater hydrophilicity than the polyurethane foam of a fluid collection assembly 100 configured for long-term use with individuals having average to small sized bladders.

[0019] In one embodiment, the hydrophilicity of the polyurethane foam may be an inherent property of the polyurethane foam, hi one embodiment, the hydrophilicity of the polyurethane foam may be altered by adding at least one of impurities (e.g., fibers) or functional groups to the polyurethane foam, otherwise treating the polyurethane foam, or coating the polyurethane foam with a material that exhibits a different hydrophilicity than the polyurethane foam.

[0020] The polyurethane foam defines one or more pores. The pores form passageways through the polyurethane foam through which one or more bodily fluids can flow. In one embodiment, the polyurethane foam has about 4 pores / cm. 2 ~ 6 holes / cm 2 , 5 holes / cm 2 ~ 7 holes / cm 2 , 6 holes / cm 2 ~ approx. 8 holes / cm 2 , 7 holes / cm 2 ~ approx. 9 holes / cm 2 , 8 holes / cm 2 ~ approx. 10 holes / cm 2 , 9 holes / cm 2 ~ approx. 11 holes / cm 2 , 10 holes / cm 2 ~ approx. 12 holes / cm 2 , 11 holes / cm 2 ~ approx. 13 holes / cm 2 , 12 holes / cm 2 ~ approx. 14 holes / cm 2 , 13 holes / cm 2 ~ approx. 15 holes / cm 2 , 14 holes / cm 2 ~ approx. 16 holes / cm 2 , or 15 holes / cm 2 ~ approx. 17 holes / cm 2 The porosity of the polyurethane foam can be selected based on the desired maximum amount of bodily fluids that can flow through the polyurethane foam in a given period of time, the density of the polyurethane foam, and the roughness of the surface of the polyurethane foam, which affects the degree of comfort of the polyurethane foam against the vaginal area.

[0021] The porosity of the polyurethane foam also depends on the average lateral dimension of the pores along a direction perpendicular to the longitudinal axis 118 of the fluid collection assembly 100 . The average lateral dimension of the pores can be selected to be about 100 μm to about 300 μm, about 200 μm to about 400 μm, about 300 μm to about 500 μm, about 400 μm to about 600 μm, about 500 μm to about 700 μm, about 600 μm to about 800 μm, about 700 μm to about 900 μm, about 800 μm to about 1 mm, about 900 μm to about 1.2 mm, about 1 mm to about 1.5 mm, about 1.25 mm to about 1.75 mm, about 1.5 mm to about 2 mm, about 1.75 mm to about 2.5 mm, about 2 mm to about 3 mm, about 2.5 mm to about 3.5 mm, about 3 mm to about 4 mm, about 3.5 mm to about 4.5 mm, or about 4 mm to about 5 mm. In general, increasing the average lateral dimension of the stoma may decrease the porosity, decrease the density of the polyurethane foam, and increase the amount of bodily fluid that can be received within the polyurethane foam at a given time. However, increasing the average lateral dimension of the stoma may increase the roughness of the surface of the polyurethane foam, making the polyurethane foam more comfortable when in contact with the vaginal area. Thus, the average lateral dimension of the stoma of the polyurethane foam may be selected based on balancing these factors. For example, a fluid collection assembly configured for use with individuals exhibiting large bladders or that includes a gauze layer covering the polyurethane foam (as shown in FIG. 2A or 2B) may include a polyurethane foam that exhibits a larger average lateral dimension of the stoma than the polyurethane foam of a fluid collection assembly configured for use with individuals having average or small bladders and / or configured to place the polyurethane foam in direct contact with the vaginal area.

[0022] Polyurethane foam is approximately 70 kg / m 3 ~about 90kg / m 3 , about 80kg / m 3 ~about 100kg / m 3 , about 90kg / m 3 ~Approx. 110kg / m 3 , about 100kg / m 3 ~Approx. 120kg / m 3 , about 110kg / m 3~Approx. 130kg / m 3 , about 120kg / m 3 ~Approx. 140kg / m 3 , or about 130 kg / m 3 ~Approx. 150kg / m 3 The polyurethane foam may exhibit an average density of 0.1 to 0.5 mm. In general, decreasing the density of the polyurethane foam may result in at least one of an increase in the porosity of the polyurethane foam, an increase in the average lateral dimension of the pores, an increase in the amount of bodily fluid that can be received within the polyurethane foam at a given time, an increase in the surface roughness of the polyurethane foam, and a decrease in the strength and toughness of the polyurethane foam. Thus, the density of the polyurethane foam may be selected based on balancing these factors, as discussed above.

[0023] The polyurethane foam can absorb body fluids within itself at a rate of about 10 milliliters per second ("mL / s") or more, about 12.5 mL / s or more, about 15 mL / s or more, about 17.5 mL / s or more, about 20 mL / s or more, about 22.25 mL / s, about 25 mL / s or more, about 27.5 mL / s or more, about 30 mL / s or more, about 35 mL / s or more, about 40 mL / s or more, or at a rate of about 10 mL / s to about 15 mL / s, about 1 The polyurethane foam may be configured to receive bodily fluids at a rate ranging from about 2.5 mL / s to about 17.5 mL / s, about 15 mL / s to about 20 mL / s, about 17.5 mL / s to about 22.5 mL / s, about 20 mL / s to about 25 mL / s, about 22.5 mL / s to about 27.5 mL / s, about 25 mL / s to about 30 mL / s, about 27.5 mL / s to about 35 mL / s, or about 30 mL / s to about 40 mL / s. As discussed above, the rate at which the polyurethane foam receives bodily fluids depends at least in part on the porosity, average lateral dimension of the pores, density, and hydrophilicity of the polyurethane foam.

[0024] As discussed above, the polyurethane foam can be formed from a hydrophilic material, which allows the polyurethane foam to retain bodily fluids within the polyurethane foam. To reduce the amount of bodily fluid retained by the polyurethane foam, the outer layer 112 can be constructed to be relatively thin. For example, the outer layer 112 can be configured to exhibit a thickness, measured perpendicular to the longitudinal axis 118 (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 0.8 mm or less, about 0.7 mm or less, about 0.6 mm or less, about 0.5 mm or less, about 0.4 mm or less, about 0.3 mm or less, about 0.2 mm or less, or in a range from about 0.2 mm to about 0.4 mm, about 0.3 mm to about 0.5 mm, about 0.4 mm to about 0.6 mm, about 0.5 mm to about 0.7 mm, about 0.6 mm to about 0.8 mm, about 0.7 mm to about 1 mm, about 0.8 mm to about 1.25 mm, about 1 mm to about 1.5 mm, or about 1.25 mm to about 2 mm. The relatively small thickness of the outer layer 112 reduces the overall volume of the polyurethane foam, thereby reducing the volume of bodily fluid that can be retained within the polyurethane foam. The reduced volume of bodily fluid retained within the polyurethane foam allows airflow through the cavities 104 to quickly evaporate the bodily fluid retained within the polyurethane foam, thereby keeping the porous material 110 dry. Additionally, the reduced thickness of the outer layer 112 may allow the inner layer 114 (e.g., polyethylene foam) to draw more bodily fluid from the polyurethane foam.

[0025] In one example, the polyurethane foam of the outer layer 112 may be formed by extrusion, such as by coextrusion with the inner layer 114. In one example, the polyurethane foam may be formed as a sheet (e.g., using molding, casting, extrusion, or tape casting techniques) and then placed over the inner layer 114. In one example, the polyurethane foam may be molded or cast over (e.g., around) a pre-formed inner layer 114.

[0026] In some embodiments, the outer layer 112 may include at least one additional material instead of or in addition to polyurethane foam. In one example, the additional material of the outer layer 112 may include a gauze (e.g., silk, linen, or cotton gauze), a woven material, a nonwoven material, a fabric such as another soft fabric, another smooth fabric, a polyethylene foam, or another suitable porous material. Forming the additional material of the outer layer 112 from a gauze, a soft fabric, and / or a smooth fabric may reduce the occurrence of wounds caused by the fluid collection assembly 100. In one example, the additional material of the outer layer 112 may exhibit hydrophobicity, porosity, average lateral dimension of the pores, density, or rate at which the additional material can receive bodily fluids that are the same or different from the hydrophobicity, porosity, average lateral dimension of the pores, density, or rate at which the additional material can receive bodily fluids (e.g., mL / s) described above with respect to polyurethane foam.

[0027] As discussed above, the porous material 110 may include an inner layer 114 disposed within the cavity 104. The outer layer 112 may be formed from a relatively foldable, flimsy, or otherwise easily deformable material such that the inner layer 114 is configured to support the outer layer 112. For example, the inner layer 114 may be positioned such that the outer layer 112 is disposed between the inner layer 114 and the fluid impermeable barrier 102. In that manner, the inner layer 114 may support the outer layer 112 and maintain its position.

[0028] As discussed above, the inner layer 114 may include polyethylene foam. In one embodiment, the polyethylene foam may be hydrophobic. The hydrophobic nature of the polyethylene foam allows the polyethylene foam to rapidly push or draw bodily fluids through the polyethylene foam and into an outlet of the fluid collection assembly 100 (e.g., into the fluid outlet 108 or into the inlet of a conduit 116 disposed within the cavity 104). Pushing or drawing bodily fluids into the outlet of the fluid collection assembly 100 allows the porous material 110 to be dry or substantially dry immediately after receiving the bodily fluid. A polyethylene foam can be hydrophobic if it exhibits a contact angle with water (a major component of bodily fluids) of about 90° to about 100°, about 95° to about 105°, about 100° to about 110°, about 105° to about 115°, about 110° to about 120°, about 115° to about 125°, about 120° to about 130°, about 125° to about 135°, about 130° to about 140°, about 135° to about 145°, about 140° to about 150°, about 145° to about 155°, about 150° to about 160°, about 155° to about 165°, about 160° to about 170°, about 165° to about 175°, or about 170° to about 180°. Generally, increasing the hydrophobicity of the polyethylene foam (i.e., increasing the contact angle between the polyethylene foam and water) allows the polyethylene foam to transfer bodily fluids to an outlet more quickly. However, increasing the hydrophobicity of the polyethylene foam may decrease the amount of bodily fluid that can be received within the polyethylene foam over a period of time. However, it has been surprisingly found that by using polyurethane foam, more bodily fluids can enter the polyethylene foam than when the porous material 110 comprises other materials. Thus, the hydrophobicity of the polyethylene foam can be selected based on adequately meeting the need to transfer bodily fluids quickly to an outlet of the fluid collection assembly 100 while also allowing the polyethylene foam to receive bodily fluids from the outer layer 112.For example, a fluid collection assembly 100 configured for short-term use with individuals with large bladders may include a polyethylene foam that exhibits weaker hydrophobicity than the polyethylene foam of a fluid collection assembly 100 configured for long-term use with individuals with average to small sized bladders.

[0029] In one embodiment, the hydrophobicity of the polyethylene foam (i.e., the contact angle between the polyethylene foam and water) may be an inherent property of the polyethylene foam, hi one embodiment, the hydrophobicity of the polyethylene foam may be altered by adding at least one of impurities (e.g., fibers) or functional groups to the polyethylene foam, otherwise treating the polyethylene foam, or coating the polyethylene foam with a material that exhibits a different hydrophobicity than the polyethylene foam.

[0030] The polyethylene foam defines one or more pores. The pores form passageways through the polyethylene foam through which one or more bodily fluids can flow. In one embodiment, the polyethylene foam has 8 pores / cm 2 ~ approx. 10 holes / cm 2 , 9 holes / cm 2 ~ approx. 11 holes / cm 2 , 10 holes / cm 2 ~ approx. 12 holes / cm 2 , 11 holes / cm 2 ~ approx. 13 holes / cm 2 , 12 holes / cm 2 ~ approx. 14 holes / cm 2 , 13 holes / cm 2 ~ approx. 15 holes / cm 2 , 14 holes / cm 2 ~ approx. 16 holes / cm 2 , 15 holes / cm 2 ~ approx. 17 holes / cm 2 , approximately 16 holes / cm 2 ~ approx. 18 holes / cm 2 , 17 holes / cm 2 ~ approx. 19 holes / cm 2 , 18 holes / cm 2~ 20 holes / cm 2 , 19 holes / cm 2 ~ approx. 21 holes / cm 2 , about 20 holes / cm 2 ~ approx. 22 holes / cm 2 , 21 holes / cm 2 ~ approx. 23 holes / cm 2 , 22 holes / cm 2 ~ approx. 24 holes / cm 2 , 23 holes / cm 2 ~ approx. 25 holes / cm 2 , approximately 24 holes / cm 2 ~ approx. 26 holes / cm 2 , 25 holes / cm 2 ~ approx. 27 holes / cm 2 , 26 holes / cm 2 ~ Approximately 28 holes / cm 2 , 27 holes / cm 2 ~ approx. 29 holes / cm 2 , or approximately 28 holes / cm 2 ~ approx. 30 holes / cm 2 The porosity of the polyethylene foam can be selected based on the desired amount of bodily fluid that can be received by and flow through the polyethylene foam over a period of time, the average lateral dimension of the pores, and the density of the polyethylene foam.

[0031] The porosity of the polyethylene foam also depends on the average lateral dimension of the pores along a direction perpendicular to the longitudinal axis 118 of the fluid collection assembly 100 . The average lateral dimension of the pores can be selected to be about 100 μm to about 300 μm, about 200 μm to about 400 μm, about 300 μm to about 500 μm, about 400 μm to about 600 μm, about 500 μm to about 700 μm, about 600 μm to about 800 μm, about 700 μm to about 900 μm, about 800 μm to about 1 mm, about 900 μm to about 1.2 mm, about 1 mm to about 1.5 mm, about 1.25 mm to about 1.75 mm, about 1.5 mm to about 2 mm, about 1.75 mm to about 2.5 mm, about 2 mm to about 3 mm, about 2.5 mm to about 3.5 mm, about 3 mm to about 4 mm, about 3.5 mm to about 4.5 mm, or about 4 mm to about 5 mm. In general, increasing the average lateral dimension of the pores decreases the porosity, decreases the density of the polyethylene foam, and may increase the amount of bodily fluid that can be received within and flow through the polyethylene foam in a given period of time. However, increasing the average lateral dimension of the pores may weaken the polyethylene foam and allow bodily fluids to pool within it. Thus, the average lateral dimension of the pores of the polyethylene foam may be selected based on balancing these factors.

[0032] Polyethylene foam is approximately 60 kg / m 3 ~about 80kg / m 3 , about 70kg / m 3 ~about 90kg / m 3 , about 80kg / m 3 ~about 100kg / m 3 , about 90kg / m 3 ~Approx. 110kg / m 3 , about 100kg / m 3 ~Approx. 120kg / m 3 , about 110kg / m 3 ~Approx. 130kg / m 3 , about 120kg / m 3 ~Approx. 140kg / m 3 , or about 130 kg / m 3 ~Approx. 150kg / m 3The polyethylene foam may exhibit an average density of 0.1 to 0.5 μm. In general, decreasing the density of the polyethylene foam may result in at least one of an increase in the porosity of the polyethylene foam, an increase in the average lateral dimension of the pores, an increase in the amount of bodily fluid that can be received within and flow through the polyethylene foam over a given period of time, and a decrease in the strength and toughness of the polyethylene foam. Thus, the density of the polyethylene foam may be selected based on balancing these factors, as discussed above.

[0033] The polyethylene foam of the inner layer 114 may be formed using any suitable technique. In one example, the polyethylene foam may be formed into a cylindrical or generally cylindrical shape (e.g., a generally hollow cylindrical shape) by casting or molding techniques. In one example, the polyethylene foam may be extruded, such as co-extruded with the outer layer 112. In one example, the polyethylene foam may be formed as a sheet (e.g., by molding, casting, extrusion, or tape casting) and then rolled to form a cylindrical or generally cylindrical shape.

[0034] In one embodiment, the outer layer 112 includes polyurethane foam and the inner layer 114 includes polyethylene foam. It has been found that selecting the porous material 110 to include both polyurethane foam and polyethylene foam may enable the porous material 110 to receive bodily fluids more quickly, move the bodily fluids to the outlet of the fluid collection assembly 100 more quickly, and keep the porous material 110 drier than if the porous material 110 included only one of the polyurethane foam and the polyethylene foam. For example, it has been found that bodily fluids received within the polyurethane foam can flow quickly from the polyurethane foam to the polyethylene foam. Additionally, the polyethylene foam may remove at least some of the bodily fluids from the polyurethane foam that would otherwise remain within the polyurethane foam.

[0035] In one embodiment, when the porous material 110 includes polyurethane foam and polyethylene foam, the polyurethane foam may exhibit a porosity that is less than that of the polyethylene foam and a density that is greater than that of the polyethylene foam. In such an embodiment, it is believed that bodily fluids may be able to flow more efficiently from the polyurethane foam to the polyethylene foam.

[0036] In some embodiments, the inner layer 114 can include at least one additional material instead of or in addition to the polyethylene foam. In one example, the additional material of the inner layer 114 can include a fabric such as gauze (e.g., silk, linen, or cotton gauze), a woven material, a nonwoven material, a porous polymer (e.g., nylon, polyester, polyurethane, polyethylene, polypropylene, etc.) structure or an open cell foam (e.g., spun nylon fibers), any other porous material disclosed herein, or any other suitable porous material. In one example, the additional material of the inner layer 114 can exhibit hydrophobicity, porosity, average lateral dimension of the pores, density, or rate at which the additional material can receive bodily fluids that are the same as or different from the hydrophobicity, porosity, average lateral dimension of the pores, density, or rate at which the additional material can receive bodily fluids discussed above with respect to the polyethylene foam.

[0037] In one embodiment, at least one of the outer layer 112 or the inner layer 114 may be omitted from the porous material 110 .

[0038] The porous material 110 may at least substantially completely fill the portion of the cavity 104 not occupied by the conduit 116. In some embodiments, the porous material 110 may not substantially completely fill the portion of the cavity 104 not occupied by the conduit 116. In such embodiments, the fluid collection assembly 100 includes a reservoir 120 disposed within the cavity 104.

[0039] The reservoir 120 is a substantially unoccupied portion of the cavity 104. The reservoir 120 may be defined between the fluid impermeable barrier 102 and one or both of the exterior layer 112 or the interior layer 114. Bodily fluid present in the cavity 104 may flow through the porous material 110 to the reservoir 120. The reservoir 120 may hold bodily fluid within.

[0040] Bodily fluid within the cavity 104 can flow through the porous material 110 to the reservoir 120. The fluid impermeable barrier 102 can retain the bodily fluid within the reservoir 120. The reservoir 120 is shown in a distal end region 122, but can be located in any portion of the cavity 104, such as in a proximal end region 124. The reservoir 120 can be located in a portion of the cavity 104 that is designed to be at a low point on the gravity basis of the fluid collection assembly when the fluid collection assembly is attached.

[0041] In some embodiments (not shown), the fluid collection assembly 100 may include multiple reservoirs, such as a first reservoir located in a portion of the cavity 104 closest to the inlet of the conduit 116 (e.g., distal end region 122) and a second reservoir located in a portion of the cavity 104 at or adjacent to the proximal end region 124. In another embodiment, the inner layer 114 may be spaced apart from at least a portion of the conduit 116, and the reservoir 120 may be the space between the inner layer 114 and the conduit 116.

[0042] The conduit 116 can be disposed at least partially within the cavity 104. The conduit 116 can be used to remove bodily fluids from the cavity 104. The conduit 116 includes at least one wall defining an inlet, an outlet (not shown) downstream from the inlet, and a passageway. The outlet of the conduit 116 can be operably coupled to a vacuum source, such as a vacuum pump, for drawing fluid from the cavity 104 through the conduit 116. For example, the conduit 116 can extend from the proximal end region 124 into the fluid-impermeable barrier 102 and can extend to the distal end region 122 adjacent the reservoir 120 therein such that the inlet is in fluid communication with the reservoir 120. The conduit 116 fluidly connects the cavity 104 to a fluid reservoir (not shown) or a vacuum source (not shown).

[0043] The conduit 116 can extend through a lumen within the porous material 110. In one embodiment, the conduit 116 extends from the fluid outlet 108 through the lumen to a location proximate the reservoir 120. In such an embodiment, the inlet may not extend into the reservoir 120, instead the inlet may be located within or at a terminal end of the porous material 110. For example, the end of the conduit 116 may be flush with the porous material 110 or may be embedded within the porous material 110. In one embodiment, the conduit 116 is at least partially located within the reservoir 120, and the inlet may extend into or be located within the reservoir 120. Bodily fluid collected within the fluid collection assembly 100 can be removed from the cavity 104 via the conduit 116.

[0044] By locating the inlet of the conduit 116 at or near a location that is expected to be a gravitational low point in the cavity 104 when worn by an individual, the conduit 116 may receive more bodily fluid than if the inlet were located at another location, reducing stagnation-like conditions (e.g., stagnation of bodily fluids may lead to microbial growth and foul odors). For example, bodily fluids within the porous material 110 may flow in any direction due to capillary forces. However, bodily fluids may exhibit a preference to flow in the direction of gravity, especially when the porous material 110 is at least partially filled with bodily fluid. Thus, one or more inlets or reservoirs 120 of the conduit 116 may be located at a location in the fluid collection assembly 100 that is expected to be a gravitational low point in the fluid collection assembly 100 when worn by an individual, such as at a distal end region 122.

[0045] The conduit 116 is configured to allow a vacuum source (not shown) to be in fluid communication with the cavity 104 (e.g., reservoir 120). Upon application of a vacuum / suction force at the conduit 116 by the vacuum source, bodily fluid within the cavity 104 (e.g., at the distal end region 122, such as in the reservoir 120) may be drawn into the inlet of the conduit 116 and through the conduit 116 out of the fluid collection assembly 100. In some embodiments, the conduit 116 may be frosted or opaque to reduce the visibility of bodily fluid therein.

[0046] The fluid collection assembly disclosed herein may include one or more additional layers instead of or in addition to at least one of the outer layer or inner layer. FIG. 2A is a cross-sectional schematic diagram of a fluid collection assembly 200 according to one embodiment. FIG. 2B is a cross-sectional schematic diagram of the fluid collection assembly along the plane 2B-2B shown in FIG. 2A. Except as otherwise disclosed herein, the fluid collection assembly 200 is the same as or substantially similar to any fluid collection assembly disclosed herein. For example, the fluid collection assembly 200 may include a fluid-impermeable barrier 202 that at least defines a cavity 204 and at least one opening 206. The fluid collection assembly 200 may also include at least one porous material 210 disposed within the cavity 204. The porous material 210 may include an outer layer 212 and an inner layer 214.

[0047] The porous material 210 may include one or more additional layers 226 instead of or in addition to the outer layer 212 or the inner layer 214. In one embodiment, the additional layer 226 may be disposed on a surface of the outer layer 212 and extend across the opening 206, as shown. In such an embodiment, the additional layer may include a gauze or other material that may be comfortable against the vaginal area of ​​the individual or more visually pleasing than the outer layer 212. It is noted that the thickness of the additional layer 226 may be minimized (e.g., about 1 mm or less, or about 0.5 mm or less) so that any effect the additional layer 226 has on the porous material 210 receiving bodily fluids discharged by the individual is minimized. In one embodiment, the additional layer 226 is disposed between the outer layer 212 and the inner layer 214. In one embodiment, the additional layer 226 may be disposed between the inner layer 214 and the conduit 216.

[0048] In some embodiments, the porous material 210 may include one or more additional layers. For example, the porous material 210 may include one or more additional layers disposed on at least one of the outer layer 212, between the outer layer 212 and the inner layer 214, or within the inner layer 214. The one or more additional layers may include any porous material disclosed herein.

[0049] The fluid collection assemblies shown in Figures 1A-2B are examples of female fluid collection assemblies configured to collect bodily fluids from a woman (e.g., collect urine from a female urethra). However, the fluid collection assemblies, fluid collection systems, and fluid collection methods disclosed herein may include male fluid collection assemblies that are shaped, dimensioned, and otherwise configured to collect bodily fluids from a man (e.g., collect urine from a male urethra). Figure 3 is a cross-sectional view of a male fluid collection assembly 300, according to one embodiment.

[0050] 3, the fluid collection assembly 300 includes a base 330 (e.g., an annular base) and a sheath 332. The base 330 is sized, shaped, and made of a material to be coupled to the skin surrounding the male urethral opening (e.g., the penis) and through which the male urethral opening is positioned. For example, the base 330 can define an aperture 334. The base 330 can be sized and shaped to be placed around the male urethral opening (e.g., around or on the penis) and the aperture 334 can be configured to be positioned through which the male urethral opening is positioned. The base 330 can also be sized, shaped, made of a material, or otherwise configured to be coupled to (e.g., adhesively attached, such as with a hydrogel adhesive) the skin around the male urethral opening (e.g., around the penis). In one embodiment, the base 330 can assume the general shape or contour of the skin surface to which the base 330 is selected to be coupled. The base 330 may be flexible, allowing it to conform to any shape of the skin surface. The base 330 also defines a hollow region that is configured to receive (e.g., seal against) the sheath 332. The base 330 is located at a proximal (relative to the wearer) end region 324 of the fluid collection assembly 300.

[0051] The sheath 332 comprises (e.g., can be formed from) a fluid-impermeable barrier 302 that is sized and shaped to fit into the hollow region of the base 330. For example, the sheath 332 can be generally tubular or cup-shaped as shown. The generally tubular or cup-shaped fluid-impermeable barrier 302 can at least partially define an outer surface 336 of the sheath 332. The fluid-impermeable barrier 302 can be similar or identical to any fluid-impermeable barrier disclosed herein in one or more embodiments. For example, the fluid-impermeable barrier 302 can be constructed of any material disclosed herein for a fluid-impermeable barrier. The fluid-impermeable barrier 302 at least partially defines a cavity 304. For example, an inner surface 338 of the fluid-impermeable barrier 302 at least partially defines a perimeter of the cavity 304. The cavity 304 at least temporarily retains bodily fluids therein. As shown, the fluid collection assembly 300 can include a porous material 310 therein. The porous material 310 can be similar or identical to any of the porous materials disclosed herein, in one or more embodiments. For example, the porous material 310 can include one or more of an inner layer 312, an outer layer 314, or one or more additional layers. The inner layer 312 can include polyurethane and / or the outer layer 314 can include polyethylene. The fluid impermeable barrier 302 can also define an opening 306 extending therethrough that is configured to be positioned for the male urethral meatus to pass therethrough.

[0052] The sheath 332 also includes at least a portion of the conduit 316 therein, such as at least partially disposed within the cavity 304. For example, the conduit 316 may extend from the sheath 332 at a distal end region 322 to a proximal end region 324 that is proximate to at least the opening 306. The proximal end region 324 may be disposed at or near the surface of the skin around the male urethral opening (e.g., on the penis or the surrounding pubic area). Thus, when an individual is lying on their back, bodily fluids (e.g., urine) may collect near the opening 306 against the subject's skin. The bodily fluids may be removed from the cavity 304 via the conduit 316.

[0053] In some embodiments, the fluid impermeable barrier 302 may be constructed of a material and / or have a thickness that allows it to collapse when the sheath 332 is placed under a vacuum so as to remove air from around the penis within the fluid collection assembly 300 during use. In such embodiments, the conduit 316 may extend only to or within the distal end region 322 of the cavity 304 (e.g., without extending therethrough to the region adjacent the opening 306). In such embodiments, urine may be collected and removed from the fluid collection assembly 300.

[0054] In one embodiment, some portions of the cavity 304 may be substantially empty due to the variety of sizes and hardness of male penises. However, in some embodiments, the outermost region of the cavity 304 (e.g., the periphery of the interior region of the sheath 332) may comprise a porous material 310. For example, the porous material 310 may be adhered to the inner surface 338 of the fluid impermeable barrier 302. The porous material 310 may be positioned (e.g., at the distal end of the cavity 304) to attenuate the flow of urine from the male urethral meatus, thereby preventing splashing, and / or to direct bodily fluids to selected regions of the cavity 304. Because the cavity 304 is substantially empty (e.g., substantially all of the cavity 304 forms a reservoir), bodily fluids tend to pool in the cavity 304 at low gravitational points. The gravity low point of cavity 304 may be where the individual's skin abuts fluid collection assembly 300, a corner formed in sheath 332, or another suitable location, depending on the wearer's body position.

[0055] As described above, the porous material 310 may include one or more of the outer layer 312 or the inner layer 314. One or more of the outer layer 312 or the inner layer 314 may be disposed between the fluid impermeable barrier 302 and the penis inserted into the cavity 304. The outer layer 312 may be disposed between the fluid impermeable barrier 302 and the penis inserted into the cavity 304, such as between the inner layer 314 and the wearer's penis as shown. The inner layer 314 may be disposed between the outer layer 312 and the fluid impermeable barrier 302. The inner surface 338 may be coated with one or both of the outer layer 312 and the inner layer 314, optionally including an end of the cavity 304 substantially opposite the opening 306. The outer layer 312 or the inner layer 314 may be attached (e.g., glued) to the fluid impermeable barrier 302. The outer layer 312 and the inner layer 314 may be attached to one another. In some embodiments, the porous material 310 only includes the outer layer 312 or the inner layer 314 .

[0056] The fluid collection assembly 300 includes a cap 340 at the distal end region 322. The cap 340 defines an internal conduit through which bodily fluids can be removed from the fluid collection assembly 300. The internal conduit is in fluid communication with the cavity 304. The cap 340 can be disposed over at least a portion of the distal end region 322 of one or more of the fluid impermeable barrier 302 or the porous material 310. The cap 340 can be made of a polymer, rubber, or any other fluid impermeable material. The cap 340 can be attached to one or more of the fluid impermeable barrier 302, the porous material 310, or the conduit 316. The cap 340 can cover at least a portion of the distal end region 322 of the fluid collection assembly 300. The cap 340 can define a fluid outlet 308 that is sized and configured to receive the conduit 316 and be fluidly sealed therewith. The conduit 316 may extend a distance, such as into or through the cap 340 to the porous material 310, through the porous material 310, or to a point spaced apart from the porous material 310. In the latter example, the internal conduit of the cap 340 may define a reservoir 320 therein.

[0057] The reservoir 320 is a free-standing portion of the device, such as the cap 340, and is free of other materials. In some embodiments, the reservoir 320 is at least partially defined by the porous material 310 and the cap 340. During use, bodily fluid within the cavity 304 can flow through the porous material 310 to the reservoir 320. The reservoir 320 can store at least some of the bodily fluid therein and / or position the bodily fluid for removal by the conduit 316. In some embodiments, at least a portion of the porous material 310 extends continuously between at least a portion of the opening of the internal conduit and the cavity 304, allowing any bodily fluid to be wicked directly from the opening into the reservoir 320.

[0058] In some embodiments (not shown), the fluid impermeable barrier 302 can be disposed on or over the cap 340 such that it encloses the cap 340 within the cavity 304 .

[0059] In some embodiments, the sheath 332 may include the conduit 316 therein, such as with at least a portion of the conduit 316 disposed within the cavity 304. For example, the conduit 316 may extend from the sheath 332 to at least a region proximate the opening 306. The inlet of the conduit 316 may be disposed adjacent to the annular base 342. The inlet of the conduit 316 may be disposed adjacent or proximate a gravity low point of the cavity 304, such as adjacent to the annular base 342. For example, the inlet may extend to the same location as the opening 306 or may be offset from the opening 306. In some embodiments, the inlet may be disposed adjacent to the distal end region 322 of the sheath 332 (substantially opposite the opening 306).

[0060] The proximal end region 324 can be disposed near or on the skin around the male urethral meatus (e.g., around the penis) and the inlet of the conduit 316 can be disposed within the proximal end region 324. The outlet of the conduit 316 can be directly or indirectly coupled to a vacuum source. Thus, bodily fluids can be removed from the proximal end region 324 of the cavity 304 via the conduit 316.

[0061] The base 330, the sheath 332, the cap 340, and the conduit 316 may be attached together using any suitable method. For example, at least two of the base 330, the sheath 332, the cap 340, and the conduit 316 may be attached together using at least one of an interference fit, adhesive, stitching, welding (e.g., ultrasonic bonding), tape, any other suitable method, or a combination thereof.

[0062] In some embodiments (not shown), the fluid collection assembly 300 can have a one-piece design in which one or more of the sheath 332, base 330, and cap 340 are integrally formed as a single piece.

[0063] As also shown, the conduit 316 can be at least partially disposed with the cavity of the fluid collection assembly. The conduit 316 can extend from the distal end region 322 to the proximal end region 324. For example, the conduit 316 can extend through the cap 340 adjacent to the base 330. The conduit 316 is sized and positioned to be coupled to a fluid reservoir or a vacuum source. The outlet of the conduit 316 can be operably coupled, directly or indirectly, to a vacuum source. The inlet of the conduit 316 can be positioned within the cavity 304 at a location that is expected to be at a low point on the gravity basis of the fluid collection assembly in use, or the like. By positioning the inlet of the conduit 316 at a location that is expected to be at a low point on the gravity basis of the fluid collection assembly when worn by a user, bodily fluids introduced into the cavity 304 can be removed via the conduit 316 to prevent bodily fluids from accumulating or stagnating within the cavity 104.

[0064] In some embodiments, the vacuum source may be located remotely from the fluid collection assembly 300. In such embodiments, the conduit 316 may be fluidly connected to a fluid reservoir that may be located between the vacuum source and the fluid collection assembly 300.

[0065] During operation, a man using the fluid collection assembly 300 may expel bodily fluids (e.g., urine) into the cavity 304. The bodily fluids may collect or accumulate within the cavity 304. At least some of the bodily fluids may be drawn through the inlet of the conduit 316 via the inlet. The bodily fluids may be expelled from the fluid collection assembly 300 by the vacuum / suction force provided by the vacuum source.

[0066] The porous material disclosed herein can be used with fluid collection assemblies other than those shown in Figures 1A-3. Figure 4A is a perspective view of a fluid collection assembly 400, according to one embodiment. Figure 4B is a cross-sectional schematic view of the fluid collection assembly along plane 4B-4B. Although the fluid collection assembly 400 is an example of a male fluid collection assembly, in some embodiments, the fluid collection assembly 400 can be used to receive bodily fluids from a female urethral opening. The fluid collection assembly 400 comprises a sheath 432 and a base 430. The base 430 is configured to be attached (e.g., permanently attached or configured to be permanently attached) to the sheath 432. The base 430 is also configured to be attached to the area surrounding the urethral opening (e.g., the penis) of an individual.

[0067] The sheath 432 comprises a fluid impermeable barrier 402 formed at least in part from a first panel 444 and a second panel 446. The first panel 444 and the second panel 446 can be attached to each other or integrally formed together (e.g., in a manner that exhibits a single piece of construction). In one embodiment, as shown, the first panel 444 and the second panel 446 are separate sheets. The fluid impermeable barrier 402 also defines a cavity 404 between the first panel 444 and the second panel 446, an opening 406 at a proximal end region PER of the sheath 432, and a fluid outlet 408 at a distal end region DER of the sheath 432. The sheath 432 also comprises at least one porous material 410 disposed within the cavity 404.

[0068] The inner surface of the fluid impermeable barrier 402 (e.g., the inner surfaces of the first panel 444 and the second panel 446) at least partially defines a cavity 404 within the fluid collection assembly 400. The fluid impermeable barrier 402 temporarily stores bodily fluids within the cavity 404. The fluid impermeable barrier 402 can be formed from any fluid impermeable material disclosed herein. As such, the fluid impermeable barrier 402 substantially prevents bodily fluids from passing through the fluid impermeable barrier 402.

[0069] In one embodiment, at least one of the first panel 444 and the second panel 446 is formed from an at least partially transparent, fluid impermeable material, such as polyethylene, polypropylene, polycarbonate, or polyvinyl chloride. Forming at least one of the first panel 444 and the second panel 446 from an at least partially transparent, fluid impermeable material allows a person (e.g., a medical practitioner) to examine the penis. For example, the cavity 404 can include a penis receiving area 448 configured to receive an individual's penis when the penis extends into the cavity 404. The penis receiving area 448 can be defined by at least the porous material 410 and at least a portion of the at least partially transparent material of the first panel 444 and / or the second panel 446. In other words, the porous material 410 is positioned within the cavity 404 such that when a penis is inserted into the cavity 404 through the opening 406, the porous material 410 is not positioned between the penis and at least a portion of the transparent portions of the first panel 444 and / or second panel 446. The porous material 410 is generally not transparent, and thus the portions of the at least partially transparent material of the first panel 444 and / or second panel 446 that define the penis receiving area 448 form a window that allows a person to look into the penis receiving area 448 and examine the penis.

[0070] The opening 406 defined by the fluid impermeable barrier 402 provides an access route for bodily fluids to enter the cavity 404 when the penis is a buried penis and allows the penis to enter the cavity 404 (e.g., the penis receiving area 448) when the penis is not buried. The opening 406 can be defined by the fluid impermeable barrier 402 (e.g., an inner edge of the fluid impermeable barrier 402). For example, the opening 406 can be formed in and extend through the fluid impermeable barrier 402, thereby allowing bodily fluids to enter the cavity 404 from outside the fluid collection assembly 400.

[0071] The fluid impermeable barrier 402 defines a fluid outlet 408 sized to receive a conduit 416. The conduit 416 is at least partially disposed within the cavity 404 and is otherwise in fluid communication with the cavity 404 through the fluid outlet 408. The fluid outlet 408 is sized and shaped to form an at least substantially fluid-tight seal with the conduit 416, thereby substantially preventing bodily fluids from escaping the cavity 404. In one embodiment, the fluid outlet 408 may be formed from portions of the first panel 444 and the second panel 446 that are not attached or integrally formed together. In such an embodiment, the fluid impermeable barrier 402 may not include a cap that is more rigid than the surrounding portions of the fluid impermeable barrier 402, which may facilitate the manufacture of the fluid collection assembly 400, reduce the number of parts used to form the fluid collection assembly 400, and reduce the time required to manufacture the fluid collection assembly 400. It is noted that the absence of a cap may make it difficult to secure the conduit 416 to the fluid outlet 408 using an interference fit, but it may still be possible to attach the conduit 416 to the fluid outlet 408. Thus, the conduit 416 may be attached to the fluid outlet 408 by adhesive, welding, or otherwise adhering the conduit 416 to the fluid outlet 408. Attaching the conduit 416 to the fluid outlet 408 may prevent leakage and may prevent the conduit 416 from inadvertently becoming detached from the fluid outlet 408. In one embodiment, the conduit 416 may be attached to the fluid outlet 408 in the same manufacturing step that attaches the first panel 444 and the second panel 446 together.

[0072] As described above, the sheath 432 includes at least one porous material 410 exposed to the cavity 404. The porous material 410 can direct bodily fluids to one or more selected regions of the cavity 404, such as away from the penis and toward the fluid outlet 408. The porous material 410 can be formed from any of the porous materials disclosed herein. In one embodiment, the porous material 410 can be formed from a single layer, two layers (e.g., an outer layer 412 and an inner layer 414), or three or more layers (e.g., an outer layer, an inner layer, and at least one additional layer).

[0073] In one embodiment, the porous material 410 can be a sheet. Forming the porous material 410 as a sheet can facilitate the manufacturing of the fluid collection assembly 400. For example, forming the porous material 410 as a sheet can allow the first panel 444, the second panel 446, and the porous material 410 to each be a sheet. During the manufacturing of the fluid collection assembly 400, the first panel 444, the second panel 446, and the porous material 410 can be stacked and then attached to one another in the same manufacturing step. For example, the porous material 410 can have the same dimensions as the first panel 444 and the second panel 446, or more preferably, a shape that is slightly smaller than the dimensions of the first panel 444 and the second panel 446. Thus, the porous material 410 can be attached to the first panel 444 and the second panel 446 by attaching them together along their respective outer edges. The porous material 410 may be slightly smaller than the first panel 444 and the second panel 446 so that the first panel 444 and / or the second panel 446 do not extend around the porous material 410 to prevent the porous material 410 from forming a passageway through the fluid impermeable barrier 402 through which bodily fluids may escape. Additionally, the porous material 410 may be attached to the first panel 444 and / or the second panel 446 to prevent the porous material 410 from significantly moving within the cavity 404, such as to prevent the porous material 410 from clumping near the fluid outlet 408. In one embodiment, the porous material 410 may be attached (e.g., with an adhesive) to the first panel 444 or the second panel 446 before or after the first panel 444 is attached to the second panel 446. In one embodiment, the porous material 410 can simply be disposed within the cavity 404 without being attached to at least one of the first panel 444 or the second panel 446. In one embodiment, the porous material 410 can take on a shape other than a sheet, such as the shape of a hollow, generally cylindrical shape.

[0074] In general, the sheath 432 has a generally flat shape when the penis is not present in the penis receiving area 448 and the sheath 432 is placed on a flat surface. The sheath 432 has a generally flat shape because the fluid impermeable barrier 402 is formed from the first panel 444 and the second panel 446, rather than being a generally tubular fluid impermeable barrier. Additionally, as described above, the porous material 410 may be a sheet, which also results in the sheath 432 having a generally flat shape. The sheath 432 may have a generally flat shape because the fluid collection assembly 400 may not include a relatively rigid ring or cap that is more rigid than the surrounding fluid impermeable barrier 402 portions. Such rings and caps may prevent the sheath 432 from having a generally flat shape. The sheath 432 is described as having a generally flat shape because the at least one porous material 410 may cause some ridges to form within the sheath 432 depending on the thickness of the porous material 410, the fluid outlet 408 and / or conduits 416 may cause ridges to form around them, or the base 430 may pull portions of the sheath 432 around itself. It is also recognized that the sheath 432 is conformable as, during use, the sheath 432 may be placed on uneven surfaces (e.g., between the testicles, perineum, and / or thighs) and the sheath 432 may conform to those shaped surfaces, and thus the sheath 432 may not have a generally flat shape during use.

[0075] The sheath 432 may have a generally flat shape when the penis is not present in the penis receiving area 448 and the sheath 432 is resting on a flat surface, allowing the fluid collection assembly 400 to be used with buried and non-buried penises. For example, when the fluid collection assembly 400 is used with a buried penis, the penis does not extend into the penis receiving area 448, causing the sheath 432 to lie relatively flat over the aperture 434 of the base 430. When the sheath 432 lies relatively flat over the aperture 434, the porous material 410 extends over the opening 406 and aperture 434, and is in close proximity to the buried penis. The porous material 410 therefore receives and removes at least a substantial portion of the bodily fluid that would otherwise be retained against the individual's skin, thereby preventing or inhibiting bodily fluid draining from the buried penis from retaining against the individual's skin. Thus, the individual's skin remains dry, which enhances comfort when using the fluid collection assembly 400 and prevents aggravation of skin conditions. However, unlike other conventional fluid collection assemblies configured for use with buried penises, the fluid collection assembly 400 can also be used with a non-buried penis, since the non-buried penis can still be received within the penis receiving area 448 even when the penis is fully erect. Additionally, by virtue of the sheath 432 being generally flat, the fluid collection assembly 400 can be used more peacefully than if the sheath 432 were not generally flat, thereby avoiding potentially embarrassing developments.

[0076] When the sheath 432 is generally flat, the porous material 410 occupies substantially all of the cavity 404 and the penis receiving area 448 is collapsed (shown in an uncollapsed form in FIG. 4B for illustrative purposes showing the penis receiving area 448). In other words, the sheath 432 may not define an area that is not permanently occupied by the porous material 410. When the porous material 410 occupies substantially all of the cavity 404, bodily fluids that are drained into the cavity 404 tend not to remain there for a significant period of time, which could cause hygiene issues, produce odor, and / or cause discomfort and aggravation of skin conditions due to the potential for continued contact of the bodily fluids with the individual's skin.

[0077] As discussed above, the first panel 444, the second panel 446, and the porous material 410 can be selected to be relatively flexible. The first panel 444, the second panel 446, and the porous material 410 are each relatively flexible such that they cannot maintain their shape without support. The flexibility of the first panel 444, the second panel 446, and the porous material 410 allows the sheath 432 to have a generally flat shape as discussed above. The flexibility of the first panel 444, the second panel 446, and the porous material 410 also allows the sheath 432 to conform to the shape of the penis as the penis changes size and shape (e.g., erection) and minimizes any unoccupied space within the cavity 404 where bodily fluids may accumulate.

[0078] As discussed above, the fluid collection assembly 400 includes a base 430 that is configured to attach to the sheath 432. For example, the base 430 is configured to be permanently attached to the sheath 432. The base 430 is configured to be permanently attached to the sheath 432, for example, when the fluid collection assembly 400 is provided with the base 430 permanently attached to the sheath 432 or when the base 430 is provided without being permanently attached to the sheath 432, but is configured to be permanently attached to the sheath 432 at some point in the future. Permanently attached means that the sheath 432 cannot be detached from the base 430 without damaging at least one of the sheath 432 or the base 430, using a blade to separate the sheath 432 from the base 430, and / or using a chemical that breaks down the adhesive that attaches the sheath 432 to the base 430. The base 430 can be permanently attached to the sheath 432 using adhesives, sewing, heat welding, radio frequency welding, or ultrasonic bonding. In one embodiment, the base 430 is configured to be reversibly attached to the sheath 432. In one embodiment, the base 430 is integrally formed with the sheath 432.

[0079] The base 430 includes an aperture 434. The base 430 is permanently attached to the sheath 432 such that the aperture 434 is aligned with the opening 406. The base 430 is sized, shaped, and made of a material to interface with the skin surrounding the penis (e.g., the mons pubis, thighs, testicles, and / or perineum) through which the penis is placed. For example, the base 430 can define an aperture 434 configured to allow the penis to be placed through it. In one embodiment, the base 430 can assume the general shape or contour of the skin surface against which the base 430 is configured to interface. The base 430 can be flexible, allowing the base 430 to conform to any shape of the skin surface and reduce the base 430 pulling on the skin surface. The base 430 can extend laterally beyond the sheath 432, thereby increasing the surface area of ​​an individual's skin to which the fluid collection assembly 400 can be attached as compared to a substantially similar fluid collection assembly 400 that does not include a base.

[0080] As described above, the fluid collection assembly 400 includes a conduit 416. The inlet of the conduit 416 may be located near the distal end region DER of the sheath 432, which is expected to be the gravitational low point of the cavity 404 when worn by an individual.

[0081] 5 is a block diagram of a fluid collection system 550 for fluid collection, according to one embodiment. The fluid collection system 550 includes a fluid collection assembly 500, a fluid reservoir 552, and a vacuum source 554. The fluid collection assembly 500 may be identical to or substantially similar to any of the fluid collection assemblies disclosed herein. The fluid collection assembly 500, the fluid reservoir 552, and the vacuum source 554 may be fluidly coupled to one another via one or more conduits 516. For example, the fluid collection assembly 500 may be operably coupled to one or more of the fluid reservoir 552 or the vacuum source 554 via the conduit 516. Bodily fluid collected within the fluid collection assembly 500 may be removed from the fluid collection assembly 500 via the conduit 516 that protrudes into the fluid collection assembly 500. For example, the inlet of the conduit 516 may extend into the fluid collection assembly 500, such as to a reservoir therein. The outlet of the conduit 516 may extend into the fluid collection assembly 500 or into the vacuum source 554. A suction force may be introduced into the cavity of the fluid collection assembly 500 via the inlet of the conduit 516 in response to a suction (e.g., vacuum) force being applied to the outlet of the conduit 516.

[0082] The suction force can be applied to the outlet of the conduit 516 either directly or indirectly by the vacuum source 554. The suction force can be applied indirectly via the fluid reservoir 552. For example, the outlet of the conduit 516 can be disposed within the fluid reservoir 552 and the additional conduit 516 can extend from the fluid reservoir 552 to the vacuum source 554. Thus, the vacuum source 554 can apply a suction force to the fluid collection assembly 500 via the fluid reservoir 552. The suction force can be applied directly via the vacuum source 554. For example, the outlet of the conduit 516 can be disposed within the vacuum source 554. The additional conduit 516 can extend from the vacuum source 554 to a location external to the fluid collection assembly 500, such as the fluid reservoir 552. In such an embodiment, the vacuum source 554 can be disposed between the fluid collection assembly 500 and the fluid reservoir 552.

[0083] The fluid reservoir 552 is sized and shaped to hold bodily fluid therein. The fluid reservoir 552 may include a bag (e.g., a drainage bag), a bottle or cup (e.g., a collection jar), or any other enclosed container for storing bodily fluids, such as urine. In some embodiments, the conduit 516 may extend from the fluid collection assembly 500 and be attached to the fluid reservoir 552 at a first location therein. An additional conduit 516 may be attached to the fluid reservoir 552 at a second location on its surface and may extend and be attached to a vacuum source 554. Thus, a vacuum (e.g., suction force) may be drawn through the fluid collection assembly 500 via the fluid reservoir 552. Bodily fluids, such as urine, may be evacuated from the fluid collection assembly 500 using the vacuum source 554.

[0084] The vacuum source 554 may include one or more of a manual vacuum pump, an electric vacuum pump, a diaphragm pump, a centrifugal pump, a positive displacement pump, a magnetic drive pump, a peristaltic pump, or any pump configured to generate a vacuum. The vacuum source 554 may provide a vacuum or suction force to remove bodily fluids from the fluid collection assembly 500. In some examples, the vacuum source 554 may be powered by one or more of a power cord (e.g., connecting to a power socket), one or more batteries, or even a manual force (e.g., a manual vacuum pump). In some examples, the vacuum source 554 may be sized and shaped to be mounted on the exterior, surface, or interior of the fluid collection assembly 500. For example, the vacuum source 554 may include one or more miniaturized pumps, or one or more micro pumps. The vacuum sources 554 disclosed herein may comprise one or more of a switch, a button, a plug, a remote controller, or any other device suitable for activating the vacuum source 554.

[0085] 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.

[0086] A degree term (e.g., "about," "approximately," "substantially," "generally," etc.) refers to a variation that is not significant structurally or functionally. In an embodiment, when a degree term is included with a term referring to a quantity, the degree term is interpreted to mean ±10%, ±5%, or +2% of the term referring to the quantity. In an embodiment, when a degree term is used to modify a shape, the degree term means that the shape modified by the degree term has the appearance of the disclosed shape. For example, the degree term can be used to mean that the shape may have rounded corners instead of sharp corners, may have curved edges instead of straight edges, may have one or more protrusions extending from it, may be oblong, may be identical to the disclosed shape, etc.

Claims

1. 1. A fluid collection assembly comprising: cavity, at least one opening; and fluid outlet a fluid-impermeable barrier defining at least at least one porous material disposed in the cavity, the porous material comprising an inner layer and an outer layer disposed on a surface of the inner layer, the inner layer including a polyethylene foam and the outer layer including a polyurethane foam; A fluid collection assembly comprising:

2. 10. The fluid collection assembly of claim 1, wherein the polyurethane foam is hydrophilic.

3. 10. The fluid collection assembly of claim 1, wherein the polyurethane foam has an average porosity of 6 pores / cm ２ ~14 holes / cm ２ A fluid collection assembly characterized in that:

4. 10. The fluid collection assembly of claim 1, wherein the polyurethane foam has an average density of about 100 kg / m ３ ~Approx. 150kg / m ３ A fluid collection assembly characterized in that:

5. 10. The fluid collection assembly of claim 1, wherein the polyethylene foam is hydrophobic.

6. 10. The fluid collection assembly of claim 1, wherein the polyethylene foam has an average porosity of about 12 pores / cm ２ ~28 holes / cm ２ A fluid collection assembly characterized in that:

7. 10. The fluid collection assembly of claim 1, wherein the polyethylene foam has a greater number of pores per cm than the polyurethane foam. ２ 10. A fluid collection assembly comprising:

8. 10. The fluid collection assembly of claim 1, wherein the polyethylene foam has a density of 70 kg / m ３ ~Approx. 150kg / m ３ A fluid collection assembly characterized in that:

9. 10. The fluid collection assembly of claim 1, wherein the polyethylene foam has a pore density of 100 pores / cm of the polyurethane foam. ２ Number of holes / cm ２ 10. A fluid collection assembly comprising:

10. 10. The fluid collection assembly of claim 1, wherein the at least one porous material comprises one or more additional layers disposed on a surface of the polyurethane foam.

11. 2. The fluid collection assembly of claim 1, wherein the polyurethane foam extends over the at least one opening.

12. 10. The fluid collection assembly of claim 1, wherein the opening is configured to be positioned adjacent to the female urethral opening to receive bodily fluids from the female urethral opening.

13. 10. The fluid collection assembly of claim 1, further comprising a sheath comprising the fluid-impermeable barrier, the sheath being configured to receive one or more bodily fluids from the male urethral meatus by positioning the male urethral meatus through the opening.

14. 10. The fluid collection assembly of claim 1, wherein bodily fluid can be stored in the cavity for a period of more than 24 hours.

15. 1. A fluid collection assembly comprising: cavity, at least one opening; and fluid outlet a fluid-impermeable barrier defining at least at least one porous material disposed in the cavity, the porous material comprising an inner layer and an outer layer disposed on a surface of the inner layer, the inner layer comprising a hydrophobic polyethylene foam and the outer layer comprising a hydrophilic polyurethane foam; A fluid collection assembly comprising:

16. cavity, at least one opening; and fluid outlet a fluid-impermeable barrier defining at least at least one porous material disposed in the cavity, the porous material comprising an inner layer and an outer layer disposed on a surface of the inner layer, the inner layer comprising polyethylene foam and the outer layer comprising polyurethane foam; a fluid collection assembly comprising: a fluid reservoir; A vacuum source; 1. A fluid collection system comprising: The fluid collection system, characterized in that the cavity of the fluid collection assembly, the fluid storage container, and the vacuum source are fluidly connected to one another so that suction force applied to the cavity from the vacuum source removes one or more body fluids from the cavity and stores the one or more body fluids in the fluid storage container.

17. 10. The fluid collection assembly of claim 1, wherein the outer layer exhibits a thickness of about 0.4 mm or less.

18. 2. The fluid collection assembly of claim 1, wherein the polyurethane foam exhibits a greater density than the polyethylene foam.

19. 16. The fluid collection assembly of claim 15, The polyethylene foam has a pore count per cm of the polyurethane foam. ２ Number of holes / cm ２ Presenting, The polyurethane foam exhibits a greater density than the polyethylene foam. A fluid collection assembly comprising:

20. 16. The fluid collection assembly of claim 15, The polyurethane foam has an average porosity of about 6 pores / cm ２ ~ about 14 holes / cm ２ and an average density of about 100 kg / m ３ ~Approx. 150kg / m ３ Within the range of The polyethylene foam has an average porosity of about 12 pores / cm ２ ~ about 28 holes / cm ２ and a density of about 70 kg / m ３ ~Approx. 150kg / m ３ A fluid collection assembly characterized in that:

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